愛德華生命科學 (EW) 2023 Q1 法說會逐字稿

Greetings, and welcome to the Edwards Lifesciences First Quarter 2023 Earnings Results. (Operator Instructions) Please note that this conference is being recorded.

您好，歡迎閱讀 Edwards Lifesciences 2023 年第一季度收益結果。 （操作員說明）請注意，正在錄製此會議。

I will now turn the conference over to our host, Mark Wilterding, Senior Vice President, Investor Relations, and Treasurer. Thank you. You may begin.

我現在將會議轉交給我們的主持人，投資者關係高級副總裁兼財務主管 Mark Wilterding。謝謝。你可以開始了。

Thank you very much, Diego, and thank you, everyone, for joining us. With me on today's call are Mike Mussallem, Chairman and CEO; Scott Ullem, CFO; and Bernard Zovighian, President of Edwards Life Sciences. Also joining us for the Q&A portion of the call are Larry Wood, our Group President of TAVR and Surgical Structural Heart; Daveen Chopra, our global leader of TMTT; and Katie Szyman, our Global Leader of Critical Care.

非常感謝 Diego，也感謝大家加入我們。和我一起參加今天電話會議的有董事長兼首席執行官 Mike Mussallem；斯科特·烏勒姆，首席財務官；和 Edwards Life Sciences 總裁 Bernard Zovighian。我們的 TAVR 和 Surgical Structural Heart 集團總裁 Larry Wood 也加入了我們的電話問答部分； Daveen Chopra，我們 TMTT 的全球領導者；以及我們的全球重症監護負責人 Katie Szyman。

Just after the close of regular trading, Edwards Lifesciences released first quarter 2023 financial results. During today's call, management will discuss those results included in the press release and accompanying financial schedules, and then use the remaining time for Q&A.

常規交易結束後，Edwards Lifesciences 發布了 2023 年第一季度財務業績。在今天的電話會議中，管理層將討論新聞稿和隨附的財務計劃中包含的這些結果，然後使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 aren't limited to, financial guidance and expectations for longer-term growth opportunities, regulatory approvals, clinical trials, litigation, reimbursement, competitive matters and foreign currency fluctuations. 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長期增長機會的預期、監管批准、臨床試驗、訴訟、報銷、競爭事項和外匯波動。這些聲明僅代表發表之日的情況，Edwards 不承擔在今天之後更新這些聲明的任何義務。

Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially. Information concerning factors that could cause these differences and important safety information may be found in the press release, our 2022 annual report on Form 10-K, and Edwards' other SEC filings, all of which are available on the company's website at edwards.com.

此外，這些陳述涉及可能導致實際結果出現重大差異的風險和不確定性。有關可能導致這些差異的因素的信息和重要的安全信息，請參見新聞稿、我們 2022 年 10-K 表格年度報告以及愛德華茲向美國證券交易委員會提交的其他文件，所有這些信息均可在公司網站 edwards.com 上找到.

Finally, a quick reminder that when using terms constant currency and adjusted, management is referring to non-GAAP financial measures. Otherwise, they are referring to GAAP results. Reconciliations between GAAP and non-GAAP numbers mentioned during the call are included in today's press release.

最後，快速提醒一下，當使用固定貨幣和調整後的術語時，管理層指的是非 GAAP 財務指標。否則，他們指的是 GAAP 結果。電話會議中提到的 GAAP 和非 GAAP 數字之間的調節包含在今天的新聞稿中。

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

有了這個，我想把電話轉給邁克，徵求他的意見。麥克風？

Thank you, Mark. We're pleased with our first quarter performance, which exceeded our expectations and reflected an improvement in health care staffing along with strong execution of our patient-focused innovation strategy.

謝謝你，馬克。我們對第一季度的業績感到滿意，這超出了我們的預期，反映出醫療保健人員配備的改善以及我們以患者為中心的創新戰略的有力執行。

Sales of $1.46 billion represented 13% growth on a constant currency basis versus the year ago period. Strong therapy adoption of transcatheter heart valves drove the majority of growth in the first quarter, aided by better-than-expected performance of surgical structural heart and critical care.

按固定匯率計算，銷售額為 14.6 億美元，同比增長 13%。得益於外科結構性心臟和重症監護的表現好於預期，經導管心臟瓣膜的強勁療法推動了第一季度的大部分增長。

By geography, strong growth in the U.S., Europe and the rest of the world was partially offset by Japan, where COVID impacts lingered. First quarter results in the U.S. were also positively impacted in the quarter by some catch-up in procedure volumes following a seasonal slowdown late last year. While staffing remains a concern at many sites globally, we are optimistic that the environment will continue to improve.

從地域上看，美國、歐洲和世界其他地區的強勁增長被日本部分抵消了，日本的疫情影響依然存在。美國第一季度的業績也受到去年年底季節性放緩後手術量有所回升的積極影響。儘管全球許多工廠的人員配置仍然是一個問題，但我們對環境將繼續改善持樂觀態度。

In TAVR, first quarter global sales were $948 million, an increase of 11% year-over-year on a constant currency basis. We estimate global TAVR procedure growth was comparable with our growth. Local selling prices were stable. In the U.S., our first quarter TAVR sales grew in the low double digits versus the prior year and we estimate total procedure growth was comparable.

在 TAVR 方面，第一季度全球銷售額為 9.48 億美元，按固定匯率計算同比增長 11%。我們估計全球 TAVR 程序的增長與我們的增長相當。本地售價穩定。在美國，我們第一季度的 TAVR 銷售額與去年同期相比增長了兩位數，我們估計整個程序的增長是可比的。

As we indicated, we believe that first quarter trends were lifted by improved hospital staffing levels. Results were also lifted by a catch-up in procedure volumes early in the quarter following the holiday season slowdown. We're optimistic about the early results of our SAPIEN 3 Ultra RESILIA launch in the U.S. As you know, the RESILIA tissue's anti-calcification technology has demonstrated a strong track record of performance in Edwards surgical valves. Adoptions of this advanced technology is proceeding well, and we expect it to represent the majority of our U.S. TAVR sales before year-end.

正如我們所指出的，我們認為第一季度的趨勢因醫院人員配備水平的提高而得到提升。假日季放緩後，本季度初手術量的回升也提振了業績。我們對我們在美國推出的 SAPIEN 3 Ultra RESILIA 的早期結果持樂觀態度。如您所知，RESILIA 組織的抗鈣化技術在 Edwards 外科瓣膜中表現出良好的業績記錄。這項先進技術的採用進展順利，我們預計它會在年底前占我們美國 TAVR 銷售額的大部分。

TAVR growth in the first quarter was driven by larger volume centers, and our SAPIEN valves continue to demonstrate distinguished clinical performance. We're pleased with the continued enrollment of our PROGRESS clinical trial studying patients with moderate AS. Related to this, last month at the ACC Conference, data were presented that examined mortality rates and cardiac damage of 600,000 early-stage AS patients in the U.S. This study concluded that all degrees of untreated AS severity were associated with increased mortality risk. Of note, the mean 2-year all-cause mortality for moderate AS was approximately 20%, approaching the rate of those with severe AS.

第一季度的 TAVR 增長是由更大容量的中心推動的，我們的 SAPIEN 瓣膜繼續表現出卓越的臨床性能。我們對研究中度 AS 患者的 PROGRESS 臨床試驗繼續招募感到高興。與此相關的是，上個月在 ACC 會議上公佈的數據檢查了美國 600,000 名早期 AS 患者的死亡率和心臟損傷。這項研究得出結論，所有程度的未經治療的 AS 嚴重程度都與死亡風險增加有關。值得注意的是，中度 AS 的平均 2 年全因死亡率約為 20%，接近重度 AS 患者的死亡率。

Outside the U.S., in the first quarter, our constant currency TAVR sales grew approximately 10% on a year-over-year basis. Growth reflected positive contributions from all regions, excluding Japan, which was still impacted by COVID and the recent trialing of competitive products. We expect to see higher OUS growth as international adoption of TAVR therapy remains low.

在美國以外，第一季度，我們的固定貨幣 TAVR 銷售額同比增長約 10%。增長反映了所有地區的積極貢獻，但日本除外，該地區仍受到 COVID 和最近試用競爭產品的影響。由於 TAVR 療法的國際採用率仍然很低，我們預計 OUS 會出現更高的增長。

In Japan, although growth was below our expectations, we are encouraged that conditions improved as the quarter progressed, and we expect COVID headwinds to diminish substantially over the course of 2023. With the launch of the SAPIEN 3 Ultra RESILIA in Japan late last month, we expect growth rates to improve in this country where aortic stenosis remains significantly undertreated relative to other large developed countries.

在日本，儘管增長低於我們的預期，但令我們感到鼓舞的是，隨著本季度的進展，情況有所改善，我們預計 COVID 逆風將在 2023 年期間大幅減少。隨著上個月底在日本推出 SAPIEN 3 Ultra RESILIA，我們預計這個國家的增長率將會提高，與其他大的發達國家相比，主動脈瓣狹窄治療仍然嚴重不足。

In Europe, Edwards sales growth was driven by the continued strong adoption of our SAPIEN platform and was broad-based across all countries. Total TAVR procedures grew over previous quarters despite persistent disruptions related to hospital staffing shortages. It's encouraging that health care systems across Europe are prioritizing life-saving structural heart therapies, including TAVR, amidst these challenges.

在歐洲，Edwards 的銷售增長是由我們的 SAPIEN 平台的持續強勁採用推動的，並且在所有國家都有廣泛的基礎。儘管與醫院人員短缺相關的持續中斷，但 TAVR 手術總數比前幾個季度有所增長。令人鼓舞的是，在這些挑戰中，歐洲的醫療保健系統正在優先考慮挽救生命的結構性心臟療法，包括 TAVR。

Looking ahead to the EuroPCR Medical Congress next month in Paris, we anticipate additional data from the Edwards benchmark study focusing on strategies to optimize TAVR programs across 28 European centers. Data will also be presented on the outcomes of balloon expandable valves for TAVR-in-TAVR procedures.

展望下個月在巴黎舉行的 EuroPCR 醫學大會，我們預計來自 Edwards 基準研究的更多數據將側重於優化 28 個歐洲中心的 TAVR 計劃的策略。還將提供有關用於 TAVR-in-TAVR 手術的球囊擴張瓣膜結果的數據。

In summary, given the strength of our first quarter performance, we now expect constant currency growth of 10% to 12% versus our previous expectation of 9% to 12%. Our outlook assumes that hospital resource constraints continue to improve during the year. We remain confident that this large global opportunity will increase to $10 billion by 2028, which implies a compounded annual growth rate in the low double digits.

總而言之，鑑於我們第一季度的強勁表現，我們現在預計貨幣增長率將保持在 10% 至 12%，而我們之前的預期為 9% 至 12%。我們的展望假設年內醫院資源限制繼續改善。我們仍然相信，到 2028 年，這一巨大的全球機遇將增加到 100 億美元，這意味著複合年增長率將達到兩位數。

Turning to TMTT. Our confidence continues to grow in the long-term potential to transform care for the many patients with mitral and tricuspid disease who need better solutions. We remain steadfast in our 3 key value drivers to unlock this opportunity, developing a portfolio of differentiated therapies for the complex mitral and tricuspid anatomies, driving positive pivotal trial results to support approvals and adoption and prioritizing favorable real-world clinical outcomes.

轉向TMTT。我們對改變許多需要更好解決方案的二尖瓣和三尖瓣疾病患者護理的長期潛力充滿信心。我們始終堅持我們的 3 個關鍵價值驅動因素來釋放這一機會，為複雜的二尖瓣和三尖瓣解剖結構開發差異化療法組合，推動積極的關鍵試驗結果以支持批准和採用，並優先考慮有利的現實世界臨床結果。

First quarter sales of $42 million grew substantially, driven by overall TEER procedure growth, the ongoing launch and growing adoption of PASCAL PRECISION in Europe and the initial launch in the United States. We're pleased that we continue to have excellent outcomes for patients, and clinician feedback on PASCAL PRECISION has been consistently positive, particularly highlighting the differentiated premium features of the system. We are ramping production to support the launches of Europe in the U.S.

第一季度 4200 萬美元的銷售額大幅增長，這主要得益於 TEER 程序的整體增長、PASCAL PRECISION 在歐洲的持續推出和越來越多的採用以及在美國的首次推出。我們很高興我們繼續為患者帶來出色的結果，臨床醫生對 PASCAL PRECISION 的反饋一直是積極的，特別是突出了該系統的差異化高級功能。我們正在提高產量以支持歐洲在美國的推出

In mitral, we look forward to presenting 1-year data from the full click cohort of Class IID pivotal trial later this year. Meanwhile, we continue to enroll the Class IIF pivotal trial with PASCAL for patients with functional mitral regurgitation. In mitral replacement, enrollment of the ENCIRCLE pivotal trial with SAPIEN M3 is ongoing, and we anticipate completing enrollment of the main cohort around the end of 2023. We believe that this replacement therapy will expand options for a broader population of mitral patients.

在二尖瓣方面，我們期待在今年晚些時候提供來自 IID 類關鍵試驗的完整點擊隊列的 1 年數據。同時，我們繼續為患有功能性二尖瓣反流的患者註冊 PASCAL 的 IIF 類關鍵試驗。在二尖瓣置換術中，使用 SAPIEN M3 進行的 ENCIRCLE 關鍵試驗的招募正在進行中，我們預計將在 2023 年底左右完成主要隊列的招募。我們相信這種替代療法將為更廣泛的二尖瓣患者提供更多選擇。

In tricuspid, we've completed enrollment of the TRISCEND II pivotal trial of the EVOQUE tricuspid valve replacement system and remain on track for European approval by the end of 2023, and in the U.S. around the end of 2024. The FDA recently approved continued access, allowing U.S. hospitals that were involved in the clinical trial, to continue to offer EVOQUE as a therapy option. In addition, the Class II TR pivotal trial with PASCAL continues enrolling well.

在三尖瓣方面，我們已經完成了 EVOQUE 三尖瓣置換系統的 TRISCEND II 關鍵試驗的註冊，並有望在 2023 年底前獲得歐洲批准，並在 2024 年底左右在美國獲得批准。FDA 最近批准繼續使用，允許參與臨床試驗的美國醫院繼續提供 EVOQUE 作為治療選擇。此外，使用 PASCAL 進行的 II 類 TR 關鍵試驗的招募情況繼續良好。

In summary, we're pleased with our continued progress toward bringing a portfolio of therapies combined with contemporary clinical data in order to achieve our vision of transforming the lives of patients with mitral and tricuspid valve disease. We now expect full year 2023 sales of $170 million to $200 million versus our previous $160 million to $200 million.

總之，我們很高興我們在將一系列療法與當代臨床數據相結合以實現我們改變二尖瓣和三尖瓣疾病患者生活的願景方面取得的持續進展。我們現在預計 2023 年全年銷售額為 1.7 億至 2 億美元，而我們之前的銷售額為 1.6 億至 2 億美元。

In Surgical Structural Heart, better-than-expected first quarter 2023 global sales of $248 million increased a robust 17% on a constant currency basis over the prior year. Growth was driven by penetration of our premium products across all regions, and valve surgery growth was higher than our expectations as hospital staffing levels improved, leading to some catch-up in procedures. We continue to see strong momentum of the RESILIA portfolio globally. Surgeons and patients value the features and benefits of this proprietary tissue technology for both aortic and mitral surgical valve replacement procedures. And we have seen adoption of the mitral valve in the U.S. increase in the first quarter.

在 Surgical Structural Heart 方面，2023 年第一季度全球銷售額 2.48 億美元，好於預期，按固定匯率計算，較上年同期強勁增長 17%。增長是由我們的優質產品在所有地區的滲透推動的，隨著醫院人員配備水平的提高，瓣膜手術的增長高於我們的預期，導致手術有所追趕。我們繼續看到 RESILIA 投資組合在全球的強勁勢頭。外科醫生和患者重視這種專有組織技術在主動脈瓣和二尖瓣外科瓣膜置換手術中的特點和優勢。我們已經看到第一季度美國採用二尖瓣的人數有所增加。

The 7-year data from our COMMENCE clinical trial will be presented at the Annual Meeting of the American Association of Thoracic Surgeons next month. We also began enrollment of our Momentis clinical trial to demonstrate the durability of RESILIA in the mitral position.

我們 COMMENCE 臨床試驗的 7 年數據將在下個月的美國胸外科醫師協會年會上公佈。我們還開始註冊我們的 Momentis 臨床試驗，以證明 RESILIA 在二尖瓣位置的耐久性。

In summary, based on our first quarter sales, we are raising our full year sales expectation to the high end of our $870 million to $970 million guidance range. We now expect high single-digit underlying growth in 2023, driven by the adoption of our most advanced technologies and an increase in the overall heart valve surgeries.

總之，根據我們第一季度的銷售額，我們將全年銷售額預期提高到 8.7 億美元至 9.7 億美元指導範圍的高端。我們現在預計，在採用我們最先進的技術和整體心臟瓣膜手術增加的推動下，2023 年將實現高個位數的潛在增長。

In Critical Care, first quarter sales of $222 million increased 9% on a constant currency basis driven by balanced contributions from all product lines. Growth was led by our Smart Recovery portfolio and strong adoption of our Acumen IQ sensor and finger cuff, featuring our unique hypotension prediction index algorithm. Demand for our Swan-Ganz pulmonary artery catheters and our HemoSphere monitoring platform also remained strong in the first quarter with a healthy pipeline of future opportunities.

在重症監護方面，第一季度銷售額為 2.22 億美元，按固定匯率計算增長了 9%，這得益於所有產品線的均衡貢獻。增長得益於我們的 Smart Recovery 產品組合以及我們 Acumen IQ 傳感器和指套的廣泛採用，採用我們獨特的低血壓預測指數算法。對我們的 Swan-Ganz 肺動脈導管和我們的 HemoSphere 監測平台的需求在第一季度也保持強勁，未來機會的健康管道。

Based on the strong first quarter performance, we now expect Critical Care full year 2023 sales of $870 million to $940 million versus our previous $840 million to $940 million. We remain excited about our pipeline of critical care innovations as we continue to shift our focus to Smart Recovery technologies designed to help clinicians make better decisions and get patients home to their families faster.

基於第一季度的強勁表現，我們現在預計 Critical Care 2023 年全年銷售額為 8.7 億至 9.4 億美元，而我們之前的銷售額為 8.4 億至 9.4 億美元。隨著我們繼續將重點轉移到智能恢復技術，旨在幫助臨床醫生做出更好的決策並讓患者更快地回家，我們仍然對我們的重症監護創新管道感到興奮。

And now I'll turn the call over to Scott.

現在我將把電話轉給斯科特。

Thanks a lot, Mike. We are very pleased by our start to the year. Q1 was particularly strong in January relative to historical seasonality, and the rest of the quarter was more consistent with our growth expectations. All product groups performed well and sales were balanced across all regions with the exception of Japan, which was impacted by lingering COVID headwinds.

非常感謝，邁克。我們對今年的開局感到非常高興。相對於歷史季節性，第一季度在 1 月份表現尤為強勁，而本季度的其餘時間更符合我們的增長預期。所有產品組都表現良好，所有地區的銷售額都保持平衡，但日本除外，該地區受到揮之不去的 COVID 不利因素的影響。

We achieved total sales in the quarter of $1.46 billion which represents 12.6% year-over-year constant currency growth. We achieved adjusted earnings per share of $0.62. Our GAAP EPS was $0.56 and impacted by an intellectual property agreement, which I will speak to later. Contribution from our stronger-than-expected sales performance was partially offset by a higher provision for performance-based compensation. A full reconciliation between our GAAP and adjusted earnings per share for these and other items is included with today's release.

我們在本季度實現了 14.6 億美元的總銷售額，同比增長 12.6%。我們實現了 0.62 美元的調整後每股收益。我們的 GAAP 每股收益為 0.56 美元，受到知識產權協議的影響，我稍後會談到。我們強於預期的銷售業績的貢獻被更高的基於績效的薪酬準備金部分抵消。我們的 GAAP 與這些和其他項目的調整後每股收益之間的全面對賬包含在今天的發布中。

For total Edwards, based on the strong start to the year, we now expect 10% to 12% year-over-year sales growth on a constant currency basis, an increase from our prior guidance of 9% to 12%. We now expect to be at the high end of our previous range of $5.6 billion to $6.0 billion. Absent material moves in foreign exchange, we now expect full year TAVR sales of $3.8 billion to $4.0 billion, TMTT sales of $170 million to $200 million, and Critical Care sales of $870 million to $940 million.

對於 Edwards 整體而言，基於今年的強勁開局，我們現在預計按固定匯率計算，銷售額同比增長 10% 至 12%，高於我們之前 9% 至 12% 的預期。我們現在預計將處於我們之前 56 億美元至 60 億美元範圍的高端。沒有實質性的外匯變動，我們現在預計全年 TAVR 銷售額為 38 億美元至 40 億美元，TMTT 銷售額為 1.7 億美元至 2 億美元，重症監護銷售額為 8.7 億美元至 9.4 億美元。

For Surgical Structural Heart, we now expect to be at the high end of our previous guidance range of $870 million to $970 million. Lastly, we now expect our full year adjusted EPS to be between $2.48 and $2.60. We're projecting second quarter sales to be between $1.48 billion and $1.56 billion. We're also projecting second quarter adjusted earnings per share of $0.62 to $0.68.

對於 Surgical Structural Heart，我們現在預計將處於我們之前 8.7 億美元至 9.7 億美元指導範圍的高端。最後，我們現在預計全年調整後每股收益將在 2.48 美元至 2.60 美元之間。我們預計第二季度銷售額在 14.8 億美元至 15.6 億美元之間。我們還預計第二季度調整後每股收益為 0.62 美元至 0.68 美元。

I'll now cover additional details of our results. For the first quarter, our adjusted gross profit margin was 77.5% as expected, compared to 77.8% in the same period last year and 81% in Q4. This slight year-over-year reduction was driven by a less favorable impact from FX. We continue to expect our full year 2023 adjusted gross profit margin to be between 76% and 78%.

我現在將介紹我們結果的更多細節。第一季度，我們調整後的毛利率達到預期的 77.5%，去年同期為 77.8%，第四季度為 81%。同比略有下降是由於外彙的不利影響所致。我們繼續預計 2023 年全年調整後的毛利率將在 76% 至 78% 之間。

Selling, general and administrative expenses in the first quarter were $436 million or 29.9% of sales, primarily reflecting increased investments over the prior year in transcatheter field-based personnel in support of our growth strategy. These investments were partially offset by the weakening of the euro and yen against the dollar. We continue to expect full year 2023 SG&A as a percent of sales to be 29% to 30% as we continue to invest in field-based personnel and our therapy adoption initiatives.

第一季度的銷售、一般和管理費用為 4.36 億美元，佔銷售額的 29.9%，主要反映了為支持我們的增長戰略而對經導管現場人員的投資比上一年有所增加。這些投資部分被歐元和日元兌美元走弱所抵消。隨著我們繼續投資於現場人員和我們的治療採用計劃，我們繼續預計 2023 年全年 SG&A 佔銷售額的百分比將達到 29% 至 30%。

Research and development expenses in the quarter grew 14% over the prior year to $261 million or 17.9% of sales. This increase was primarily the result of continued investments in our transcatheter valve innovations, including increased clinical trial activity. For the full year 2023, we continue to expect R&D to be 17% to 18% of sales as we invest in developing new technologies and generating evidence to support TAVR and TMTT.

本季度的研發費用比上年同期增長 14%，達到 2.61 億美元，佔銷售額的 17.9%。這一增長主要是由於我們持續投資於我們的經導管瓣膜創新，包括增加臨床試驗活動。對於 2023 年全年，我們繼續預計研發將佔銷售額的 17% 至 18%，因為我們投資於開發新技術和生成支持 TAVR 和 TMTT 的證據。

Turning to taxes. Our reported tax rate this quarter was 14.6%. This rate reflects a 70 basis point excess tax benefit from stock-based compensation. We continue to expect our full year tax rate, excluding special items, to be 13% to 17%.

轉向稅收。我們本季度報告的稅率為 14.6%。該比率反映了基於股票的補償所帶來的 70 個基點的超額稅收優惠。我們繼續預計我們的全年稅率（不包括特殊項目）為 13% 至 17%。

Earlier this month, we were pleased to enter into an intellectual property agreement with Medtronic, in which we agreed to a 15-year mutual covenant not to sue with regard to certain structural heart products. We previously had a long-term IP agreement that expired last year. The terms of the new agreement limit what we disclose, but there will be a reference to it in our Form 10-Q, which we will file soon. In consideration for the agreement, we paid Medtronic $300 million, approximately half of which has been recorded as a onetime charge, and the other half will be amortized over time.

本月早些時候，我們很高興與美敦力 (Medtronic) 簽訂了知識產權協議，我們在協議中同意簽訂為期 15 年的共同契約，不就某些結構性心臟產品提起訴訟。我們之前有一份去年到期的長期知識產權協議。新協議的條款限制了我們披露的內容，但我們將在很快提交的 10-Q 表格中提及它。作為協議的對價，我們向美敦力支付了 3 億美元，其中約一半已記為一次性費用，另一半將分期攤銷。

Foreign exchange rates decreased first quarter reported sales growth by 380 percentage points or $44 million compared to the prior year. At current rates, we continue to expect an approximately flat year-over-year impact to full year 2023 sales as compared to 2022. FX rates negatively impacted our first quarter gross profit margin by 70 basis points compared to the prior year. Relative to our January guidance, FX rates had a minimal impact on first quarter earnings per share.

外匯匯率下降第一季度報告的銷售額與去年同期相比增長了 380 個百分點或 4400 萬美元。按照目前的匯率，我們繼續預計與 2022 年相比，2023 年全年銷售額的同比影響大致持平。與去年同期相比，匯率對我們第一季度的毛利率產生了 70 個基點的負面影響。相對於我們 1 月份的指引，匯率對第一季度每股收益的影響微乎其微。

Free cash flow for the first quarter was $253 million, defined as cash flow from operating activities of $314 million, less capital spending of $61 million. We continue to expect full year 2023 free cash flow will be between $1.0 billion and $1.4 billion.

第一季度的自由現金流為 2.53 億美元，定義為經營活動產生的現金流 3.14 億美元減去 6100 萬美元的資本支出。我們繼續預計 2023 年全年自由現金流將在 10 億美元至 14 億美元之間。

Before turning the call back over to Mike, I'll finish with an update on our balance sheet and share repurchase activities. We continue to maintain a strong and flexible balance sheet with approximately $1.3 billion in cash, cash equivalents and short-term investments as of March 31. In the first quarter, we repurchased approximately $250 million in stock through an accelerated share repurchase agreement as well as pre-established 10b5-1 programs.

在將電話轉回 Mike 之前，我將完成資產負債表的更新並分享回購活動。截至 3 月 31 日，我們繼續保持強大而靈活的資產負債表，擁有約 13 億美元的現金、現金等價物和短期投資。第一季度，我們通過加速股票回購協議回購了約 2.5 億美元的股票以及預先制定的 10b5-1 計劃。

As a result, average diluted shares outstanding during the quarter declined by approximately 5 million shares to $611 million. We continue to expect average diluted shares outstanding for 2023 to be between $610 million and $615 million. We have approximately $650 million remaining under our current share repurchase authorization.

因此，本季度平均稀釋流通股減少約 500 萬股至 6.11 億美元。我們繼續預計 2023 年平均攤薄流通股將在 6.1 億美元至 6.15 億美元之間。根據我們目前的股票回購授權，我們還剩下大約 6.5 億美元。

And with that, I'll hand it back to Mike. But before I do, I know everyone on both ends of this call joins me in congratulating you on this, your 92nd earnings call. We're now in our tenth year of working together, and it's been a privilege at every step along the way. Your leadership and support as the CEO of Edwards has been an inspiration to me, our employees, and I know it's also fair to say, the investment community. So with that, Mike, back to you.

有了這個，我會把它交還給邁克。但在我這樣做之前，我知道電話兩端的每個人都和我一起祝賀你的第 92 次財報電話會議。我們現在已經是合作的第十個年頭了，一路走來的每一步都是一種榮幸。作為 Edwards 的首席執行官，您的領導和支持一直激勵著我、我們的員工，而且我知道這對投資界來說也是公平的。因此，邁克，回到你身邊。

Thanks so much, Scott. That means a lot, and I truly value your trusted partnership over the years. It's also a great segue. As part of the upcoming planned CEO succession, Bernard has been serving as President of Edwards Lifesciences since January 1. Since then, we've invested all our time to successfully transition responsibilities, and I feel confident passing the baton.

非常感謝，斯科特。這意義重大，我真的很重視你們這些年來值得信賴的合作夥伴關係。這也是一個很好的轉折點。作為即將到來的 CEO 繼任計劃的一部分，Bernard 自 1 月 1 日起擔任 Edwards Lifesciences 的總裁。從那時起，我們投入了所有時間來成功交接職責，我對接過接力棒充滿信心。

Next month, I expect to transition to my new role as Nonexecutive Chairman of the Board, and Bernard will assume the CEO role. I'm excited with the Board's selection of Bernard and I'm confident that the company is in great hands and will prosper under his proven leadership.

下個月，我預計將擔任董事會非執行主席的新職務，伯納德將擔任首席執行官一職。我對董事會選擇 Bernard 感到很興奮，我相信公司在他的領導下會得到很好的管理，並會繁榮發展。

But before we go to Q&A, I'll ask Bernard to say a few words, Bernard?

但在我們進行問答之前，我會請伯納德說幾句話，伯納德？

Thanks, Mike. I feel extremely fortunate to be leading this special company that has pioneered rightful technologies and transformed care for patients around the world. During the well-planned 5-month transition, Mike has been extremely generous in sharing his learnings and experience, having successfully transformed Edwards over the last 20-plus years.

謝謝，邁克。我感到非常幸運能夠領導這家開創了合法技術並改變了全球患者護理的特殊公司。在精心策劃的 5 個月過渡期間，Mike 非常慷慨地分享了他的學習和經驗，在過去 20 多年裡成功地改變了 Edwards。

I am also grateful for the support of the Board and the partnership of the executive leadership team. In recent months, I have had the pleasure of meeting and listening to our patients, our trusted partners, and our employees around the world. I've come away from this discussion even more confident in Edwards' bright future.

我也感謝董事會的支持和執行領導團隊的合作。最近幾個月，我有幸會見了我們的患者、我們值得信賴的合作夥伴以及我們在世界各地的員工，並聆聽了他們的心聲。結束了這次討論後，我對愛德華茲的光明未來更有信心了。

For our patients, we will continue to advance breakthrough innovation that will positively impact their lives. While Edwards has grown and evolved, we never lost sight of why we are here. We will stay focused on our long-term strategic goals and foster a patient-first culture that drives everything we do.

對於我們的患者，我們將繼續推進將對他們的生活產生積極影響的突破性創新。在 Edwards 成長和發展的同時，我們從未忘記我們存在的原因。我們將繼續專注於我們的長期戰略目標，並培養一種以患者為本的文化來推動我們所做的一切。

We know health care innovation requires trusted partnership with physicians, regulators, payers, providers and innovators, and we will continue to build upon and further strengthen our deep partnerships to take on ambitious goals and address large unmet needs.

我們知道醫療保健創新需要與醫生、監管機構、付款人、提供者和創新者建立可信賴的合作夥伴關係，我們將繼續建立並進一步加強我們的深度合作夥伴關係，以實現雄心勃勃的目標並解決大量未滿足的需求。

Transforming care like we do at Edwards is complex. So we remain committed to fostering a culture where our employees really enjoy their impactful work. Our unique organic innovation strategy requires an expert, motivated and dedicated global team. I want Edwards to continue to be a place that inspires our employees to grow and succeed and attract bright talent.

像我們在 Edwards 所做的那樣轉變護理是複雜的。因此，我們仍然致力於營造一種文化，讓我們的員工真正享受他們有影響力的工作。我們獨特的有機創新戰略需要一支專業、積極和敬業的全球團隊。我希望 Edwards 繼續成為激勵我們的員工成長和成功並吸引優秀人才的地方。

As you heard from Mike and Scott, we believe that 2023 will be an important year for Edwards as we expect a return to higher sales growth and meaningful progress on our innovations to improve care for many more patients. Looking beyond 2023, I remain confident that our long-term strategy and pipeline of innovative therapy will create significant value for patients and health care systems, enabling strong organic sales growth. Finally, I am confident that as we deliver on our innovation strategy, we will create exceptional shareholder value.

正如您從邁克和斯科特那裡聽到的那樣，我們相信 2023 年對 Edwards 來說將是重要的一年，因為我們預計將恢復更高的銷售增長，並在我們的創新方面取得有意義的進展，以改善對更多患者的護理。展望 2023 年以後，我仍然相信我們的長期戰略和創新療法管道將為患者和醫療保健系統創造巨大價值，實現強勁的有機銷售增長。最後，我相信，隨著我們實施創新戰略，我們將創造非凡的股東價值。

With that, I will pass it back to Mark to open up for Q&A.

有了這個，我會把它傳回給馬克開放問答。

Thank you very much, Bernard. We're ready to take questions now. (Operator Instructions) Diego, please go ahead with additional details on accessing the Q&A portion of the call.

非常感謝，伯納德。我們現在準備好接受提問了。 （操作員說明）迭戈，請繼續提供有關訪問電話問答部分的更多詳細信息。

(Operator Instructions) Our first question comes from Larry Biegelsen with Wells Fargo.

（操作員說明）我們的第一個問題來自 Wells Fargo 的 Larry Biegelsen。

Mike, I just want to say, I think I've been on almost 70 of your 92 calls. So I just want to take this opportunity to congratulate you on what you've accomplished at Edwards and wish you well on retirement. I just want to take a minute to say, I think your pursuit of transcatheter valves may seem obvious now, Mike. But we know that it was a big risk when you decided to go down that path, and it was clearly the right decision. So congratulations again, Mike, and I'll move on to my questions now.

邁克，我只想說，我想我接聽了你 92 個電話中的近 70 個。因此，我只想藉此機會祝賀您在 Edwards 取得的成就，並祝您退休後一切順利。我只想花點時間說，我認為你對經導管瓣膜的追求現在看起來很明顯，邁克。但我們知道，當您決定走這條路時，這是一個很大的風險，而這顯然是正確的決定。再次祝賀你，邁克，我現在開始回答我的問題。

So I'd love to start just with 2 on TMTT. Just first on the TMTT result in the quarter, the $42 million. I'd love to hear a little bit about the U.S. OUS trends. How much did the U.S. contribute? And just any color on the launch of PASCAL? And I have one follow-up.

所以我想從 TMTT 上的 2 開始。首先是本季度的 TMTT 結果，即 4200 萬美元。我很想听聽一些關於美國 OUS 趨勢的信息。美國貢獻了多少？ PASCAL 的推出有什麼顏色嗎？我有一個後續行動。

Yes. Why don't I get started? First of all, thanks so much, Larry. That's very meaningful to me. And you're right, we've been on a long journey together, and I really appreciate the support from the investment community. So why don't I turn it over to Bernard and Daveen to sort of answer your questions.

是的。為什麼我不開始？首先，非常感謝拉里。這對我來說非常有意義。你是對的，我們一起走過了漫長的旅程，我非常感謝投資界的支持。那麼為什麼我不把它交給 Bernard 和 Daveen 來回答你的問題呢？

Thanks, Larry. Good question about TMTT. We are very pleased with the first quarter results. As you can imagine, we started in Europe way before. And we also got the approval in Europe for PASCAL PRECISION before the U.S. So it is going very well in Europe, but we have been in the U.S. now for a quarter, quarter plus, and it is going well also. It is at the beginning of it. I don't know, Daveen, if you want to add anything here?

謝謝，拉里。關於 TMTT 的好問題。我們對第一季度的業績感到非常滿意。可以想像，我們很早以前就在歐洲起步。我們還在歐洲獲得了 PASCAL PRECISION 在美國之前的批准，所以它在歐洲進展順利，但我們現在已經在美國呆了一個季度，一個季度以上，而且進展順利。這是它的開始。我不知道，Daveen，你是否想在這裡添加任何內容？

Yes. Just to say, Europe has obviously been the majority of our revenue. But in the U.S. and in Europe, we're in launch mode with PASCAL PRECISION. We've gotten really positive feedback so far from physicians. They love the technology. They're seeing excellent safety and efficacy. And we're continuing to grow. We're continuing to open new centers, training physicians for the first time and giving exposure to this new great technology.

是的。只是說，歐洲顯然是我們收入的大部分。但在美國和歐洲，我們正處於 PASCAL PRECISION 的啟動模式。到目前為止，我們已經從醫生那裡得到了非常積極的反饋。他們喜歡這項技術。他們看到了出色的安全性和有效性。我們正在繼續成長。我們將繼續開設新的中心，首次培訓醫生並接觸這項新技術。

That's helpful. And then just to follow up on TRILUMINATE. The reaction seemed to be mixed from some physicians. I'd love to hear you guys your reaction to the data and put EVOQUE, which you've just completed the U.S. pivotal trial for, TRISCEND II, the enrollment, I'm sorry. One would expect with replacement, you're going to see better efficacy in terms of TR reduction. But how confident are you that you'll see an improvement in outcomes such as mortality and hospitalization with a reasonable safety profile?

這很有幫助。然後只是跟進 TRILUMINATE。一些醫生的反應似乎喜憂參半。我很想听聽你們對數據的反應，並把你們剛剛完成美國關鍵試驗 TRISCEND II 的 EVOQUE 註冊，我很抱歉。人們會期望通過更換，您將在減少 TR 方面看到更好的功效。但是，您對在合理的安全狀況下看到死亡率和住院率等結果的改善有多大信心？

Yes. Sure. Thanks, Larry. Daveen again. I'll jump in a little bit on our thoughts on TRILUMINATE. Honestly, on TRILUMINATE, we're very pleased to see a high-quality randomized controlled data for the treatment of tricuspid regurgitation for the first time. We're excited to see that this trial showed that tricuspid TEER is not only safe, but offers significant TR reduction and also offers really meaningful quality of life for patients.

是的。當然。謝謝，拉里。又是達文。我將談談我們對 TRILUMINATE 的看法。老實說，在 TRILUMINATE 上，我們很高興首次看到治療三尖瓣反流的高質量隨機對照數據。我們很高興看到這項試驗表明三尖瓣 TEER 不僅安全，而且顯著降低 TR，還為患者提供真正有意義的生活質量。

And I think what we see is that the TRILUMINATE data actually kind of helps confirm outcomes that we've seen in previous PASCAL studies in the tricuspid space, like our CLASP TR EFS, TriCLASP study, et cetera, that we really see the significant TR reduction, great safety and good quality of life. For us, obviously, the Class II TR study is ongoing and maybe that'll give us some more potential on tricuspid TEER therapy.

我認為我們看到的是，TRILUMINATE 數據實際上有助於確認我們在之前的三尖瓣空間 PASCAL 研究中看到的結果，例如我們的 CLASP TR EFS、TriCLASP 研究等，我們確實看到了顯著的 TR減少，極大的安全性和良好的生活質量。顯然，對我們來說，II 類 TR 研究正在進行中，也許這會給我們帶來更多關於三尖瓣 TEER 治療的潛力。

But we also believe that you need a toolbox of technologies for tricuspid disease. And that not only does TEER offer a great solution, but we also think that tricuspid replacement also offers great solution. Obviously, as the data comes out in the future, it will help figure out and unpack a lot of the questions that you just asked right there. But I think we'll all figure this out together on this journey.

但我們也相信您需要一個三尖瓣疾病的技術工具箱。不僅 TEER 提供了一個很好的解決方案，而且我們認為三尖瓣置換術也提供了一個很好的解決方案。顯然，隨著數據在未來的出現，它將有助於找出並解開你剛才提出的許多問題。但我認為我們都會在這段旅程中一起解決這個問題。

Next question comes from Robbie Marcus with JPMorgan.

下一個問題來自摩根大通的 Robbie Marcus。

Mike, I'll add my congratulations as well. Maybe to start, I want to spend a minute on TAVR trends, U.S. and OUS, and you said there was some pent-up demand at the beginning of the quarter, but then also, it sounds like staffing continues to improve around the world. And if you get a little pricing benefit on SAPIEN 3 Ultra RESILIA that might help sales throughout the year. So I would just love to get your thoughts on what you're seeing? Do you think there was a bolus in January and it died off? Or are these trends that can continue to improve and accelerate throughout the year?

邁克，我也要表示祝賀。也許首先，我想花一點時間了解 TAVR 趨勢，美國和 OUS，你說本季度初有一些被壓抑的需求，但同時，聽起來全球的人員配置仍在繼續改善。如果您在 SAPIEN 3 Ultra RESILIA 上獲得一點定價優惠，可能有助於全年銷售。所以我很想了解您對所看到的內容的看法？你認為一月份有推注然後就消失了嗎？或者這些趨勢是否可以在全年繼續改善和加速？

Yes. Thanks, Robbie, and I appreciate your comments. Why don't we go to Larry on this one?

是的。謝謝，羅比，感謝您的評論。我們為什麼不去找拉里呢？

Yes. Thanks, Robbie. If I look at the quarter, we typically see a lot of seasonality in January as we come out of the holiday, just kind of refilling up the pipeline with screening. And we saw a much stronger January than we historically have seen, and we just saw less seasonality. I'd say February and March played out pretty much in line with our expectations. We've anticipated that staffing was going to gradually improve. And I think we see that.

是的。謝謝，羅比。如果我看一下這個季度，我們通常會在假期結束後的一月份看到很多季節性，只是通過篩選來補充管道。我們看到 1 月份的表現比以往任何時候都要強勁，只是季節性因素有所減少。我想說 2 月和 3 月的表現非常符合我們的預期。我們預計人員配置將逐漸改善。我想我們看到了。

I think that's evidenced in the Q1 results, but we expect it to also continually improve throughout the rest of the year. So in terms of trying to judge a backlog, I'm not really -- it's hard for us to do that, but we do think there was certainly some catch-up in January.

我認為第一季度的結果證明了這一點，但我們預計它在今年剩餘時間裡也會不斷改善。因此，就試圖判斷積壓而言，我並不是真的——我們很難做到這一點，但我們確實認為 1 月份肯定有一些追趕。

Great. And Scott, maybe one for you. OpEx came in a little higher than the Street had been expecting in the quarter, yet you reiterated the margin targets for the year. How should we think about the cadence of spending? And anything in the first quarter that stood at to you that won't repeat going forward?

偉大的。斯科特，也許一個給你。本季度的運營支出略高於華爾街的預期，但您重申了今年的利潤率目標。我們應該如何考慮花錢的節奏？第一季度對你來說有什麼不會重複的嗎？

Yes. So we did end up with higher spending in the first quarter than we had originally budgeted. Our plans for spending for the rest of the year are really unchanged. And for the full year, our guidance for SG&A and R&D as a percentage of sales are unchanged. In the first quarter, we came in a little bit higher for several reasons. We had some performance-based compensation. It's highly sensitive to sales by design. And so we like to reward people when the top line is performing well. We also had some little things at one time, one-off expenses for projects we were working on. We had a little bit higher tax rate as a result of income mix that came in U.S. and OUS. So those were some of the special things that you saw flow through in Q1.

是的。因此，我們在第一季度的支出確實高於我們最初的預算。我們今年剩餘時間的支出計劃實際上沒有變化。對於全年，我們對 SG&A 和 R&D 佔銷售額百分比的指導保持不變。在第一季度，由於幾個原因，我們的收入略高。我們有一些基於績效的補償。它對設計銷售高度敏感。因此，我們喜歡在頂線表現良好時獎勵員工。我們也曾經有過一些小事，比如我們正在進行的項目的一次性費用。由於美國和美國的收入組合，我們的稅率略高。因此，這些是您在第一季度看到的一些特殊情況。

Our next question comes from Vijay Kumar with Evercore.

我們的下一個問題來自 Evercore 的 Vijay Kumar。

Congrats on a good start here, and Mike, let me add my congratulations as well. I wanted to go back to a prior question here on a look at TAVR, I think it was 4%, 5% in Q4, Q1 double-digit growth. Can you quantify what that improvement from mid-single to double digits, what part of that was perhaps to catch up versus an underlying improvement in procedure trends? And when you're thinking about procedure trends, can you perhaps talk about how was the progress and what the exit rates were?

祝賀這裡有一個良好的開端，邁克，讓我也表示祝賀。我想回到之前的一個問題，看看 TAVR，我認為第四季度和第一季度的增長率分別為 4%、5% 和兩位數。您能否量化從中個位數到兩位數的改進，其中哪一部分可能是為了趕上程序趨勢的潛在改進？當您考慮程序趨勢時，您能否談談進展如何以及退出率是多少？

Yes. Thanks for your comments, Vijay. I appreciate that. I'll give it to Larry, although I think he already gave it his best shot, but wanted to see if you have anything to add, Larry?

是的。感謝您的評論，維杰。我很感激。我會把它交給拉里，雖然我認為他已經盡力了，但想看看你是否有什麼要補充的，拉里？

Yes. I don't know that I have a lot more to add on the last question. You'll note we took up the bottom of our range, and I think so we tried to reflect all of this in our guidance. But we're just encouraged overall by the staffing trends and where we're going. And I think to see TAVR back in double-digit growth after a couple of tough quarters, just really, I think, highlights that the system is getting capacity back. And I think that, that's a real plus for patients.

是的。我不知道我對最後一個問題還有很多要補充的。你會注意到我們佔據了我們範圍的底部，我認為我們試圖在我們的指南中反映所有這些。但總體而言，我們對人員配置趨勢和我們的發展方向感到鼓舞。我認為，在經歷了幾個艱難的季度後，看到 TAVR 恢復兩位數的增長，我認為，這確實凸顯了該系統正在恢復容量。我認為，這對患者來說是一個真正的好處。

Maybe I'll try to ask this a different way, Larry. Let's see if we can pin this down. So SAVR, this is the second straight quarter, SAVR is outgrowing TAVR. Is that 17% -- what percentage of that 17% is -- what is volume versus price? And do you have any thoughts on why is SAVR continuing to outgrow TAVR? Shouldn't TAVR be growing faster than SAVR?

拉里，也許我會嘗試以不同的方式提出這個問題。讓我們看看是否可以確定這一點。所以 SAVR，這是連續第二個季度，SAVR 超過 TAVR。那是 17%——這 17% 的百分比是多少——什麼是數量與價格？您對為什麼 SAVR 繼續超過 TAVR 有任何想法嗎？ TAVR 不應該比 SAVR 增長得更快嗎？

Yes. Well, I mean, I think -- first of all, we're very excited by the surgical growth that we saw in Q1. I think it probably reached probably an all-time high that we haven't seen in a long time. I think that's really a reflection of the innovation and the investments we've made over the last several years. So I think part of this has been the adoption of our premium products and the premium we get and that certainly helps our competitive position.

是的。好吧，我的意思是，我認為——首先，我們對第一季度看到的手術式增長感到非常興奮。我認為它可能達到了我們很長時間未見的歷史最高水平。我認為這確實反映了我們在過去幾年中所做的創新和投資。所以我認為部分原因是採用了我們的優質產品和我們獲得的溢價，這肯定有助於我們的競爭地位。

And at the same time, we did see procedure growth that happened that I think results from the capacity similar to what we saw in TAVR. We saw that capacity improvements on the surgical side of our business as well. But we do get some of the price from our premium products in addition to the growth in the market and then probably a little bit of competitive position as well. So there's probably more drivers on the surgical side than there are on the TAVR side.

與此同時，我們確實看到了發生的程序增長，我認為這是由於與我們在 TAVR 中看到的類似的容量造成的。我們也看到了我們業務外科方面的能力提高。但除了市場增長之外，我們確實從我們的優質產品中獲得了一些價格，然後可能還有一點競爭地位。因此，手術方面的驅動程序可能比 TAVR 方面的驅動程序更多。

Sorry, volume versus price, Larry. Can you comment whether majority of this growth was volume versus price on SAVR?

對不起，數量與價格，拉里。您能否評論這種增長的大部分是否是 SAVR 的數量與價格？

I mean, volume was certainly a key contributor to it. And I think there's no question about that. So that's a big thing. But again, yes, there's 3 things that are contributing to growth in the surgical business, whereas TAVR is pretty much primarily units.

我的意思是，銷量肯定是其中的一個關鍵因素。我認為這是毫無疑問的。所以這是一件大事。但同樣，是的，有 3 件事促進了外科業務的增長，而 TAVR 幾乎主要是單位。

Our next question comes from Joanne Wuensch with Citibank.

我們的下一個問題來自花旗銀行的 Joanne Wuensch。

Mike, you will be missed. But nice quarter to do your 92nd quarter for. I just want to spend a little bit of time on Japan and China. And particularly in Japan, if you had a tough beginning of the quarter with COVID overhang, what is your run rate looking like right now? And just on what's happening in the region.

邁克，你會被想念的。但是第 92 個季度的好季度。我只想花點時間談談日本和中國。特別是在日本，如果您在本季度開始時因 COVID 過剩而表現不佳，那麼您現在的運行率是多少？以及該地區正在發生的事情。

Yes. Thanks, Joanne. I appreciate your kind comments. Bernard, do you want to take a shot at that?

是的。謝謝，喬安妮。感謝您的友好評論。伯納德，你想嘗試一下嗎？

Yes. So Japan has been and still largely impacted by COVID headwinds. We believe it is going to diminish over the course of 2023. We are also bringing our latest technology in Japan S3 Ultra RESILIA. And we are starting to see some positive reaction from our customers here. So together with the recovery from COVID and us bringing our latest technologies, we are very hopeful for the year.

是的。因此，日本一直並且仍然在很大程度上受到 COVID 逆風的影響。我們相信它會在 2023 年期間減少。我們還將在日本 S3 Ultra RESILIA 引入我們的最新技術。我們開始看到我們客戶的一些積極反應。因此，隨著 COVID 的複蘇和我們帶來的最新技術，我們對這一年充滿希望。

Yes. The other thing I can add, Joanne, is that China is still relatively small in the TAVR front for us. Remember, we launched during the COVID years. But Japan is also going to benefit from the launch of the Ultra RESILIA product this year. And so we think that's going to be a lift for Japan as the year goes on, and it just launched here this month.

是的。喬安妮，我可以補充的另一件事是，對我們來說，中國在 TAVR 方面仍然相對較小。請記住，我們是在新冠疫情期間推出的。但日本也將受益於今年推出的 Ultra RESILIA 產品。因此，我們認為隨著時間的推移，這將對日本起到提振作用，它本月剛剛在這裡推出。

Our next question comes from Travis Steed with Bank of America.

我們的下一個問題來自美國銀行的 Travis Steed。

Congrats, Mike, you'll be missed, as well. Couple of questions here. I guess, the first, just if you normalize January -- I don't know if you could say if the U.S. still reached double digits if you just normalize the January and Q1. But then the real question is like how to think about Q2 from here? Both U.S. and worldwide cover, how much of a step-up we should expect in Q2 total TAVR sales or growth rates? Or just any color on what to expect for Q2 TAVR?

恭喜，邁克，你也會被想念的。這裡有幾個問題。我想，首先，如果你將 1 月正常化——我不知道你是否可以說如果你只是將 1 月和第一季度正常化，美國是否仍然達到兩位數。但真正的問題是如何從這裡考慮 Q2？美國和全球範圍內，我們應該期望第二季度 TAVR 總銷售額或增長率有多大的提升？或者只是對 Q2 TAVR 有什麼期待？

Okay. Travis, I appreciate that. So could you repeat your question about the Q1 growth so to make sure we get it right?

好的。特拉維斯，我很感激。那麼，您能否重複您關於第一季度增長的問題，以確保我們做對了？

Yes, of course. So January, if you normalize the January catch-up, if you will, it generally looks more normal. Did the U.S. TAVR still grow double digits? Or is it high single digits?

是的當然。所以一月份，如果你將一月份的追趕正常化，如果你願意的話，它通常看起來更正常。美國 TAVR 是否仍保持兩位數增長？還是高個位數？

Well, again, just to try to expand, we typically see fairly extreme seasonality in January, where it's our worst month of the quarter. We just didn't see as much extremism, but January was by no means our strongest month. We continue to see a ramp in the quarter. It's just February and March were pretty much in line with our expectations, where January was stronger, but it wasn't like it was our strongest month. So I hope that gives more context.

好吧，再次，只是為了擴大規模，我們通常會在 1 月份看到相當極端的季節性，這是我們本季度最糟糕的月份。我們只是沒有看到那麼多的極端主義，但 1 月絕不是我們最強勁的月份。我們繼續看到本季度的增長。只是 2 月和 3 月幾乎符合我們的預期，其中 1 月更強，但這並不是我們最強勁的月份。所以我希望這能提供更多背景信息。

And I think what we're seeing is the gradual improvement in staffing, and I think what we've tried to build into our guidance is we took up the bottom of our range because we thought we had a strong Q1, but it's kind of in our expectations now to be in that 10% to 12% range globally.

而且我認為我們看到的是人員配置的逐步改善，我認為我們試圖在我們的指導中構建的是我們佔據了範圍的底部，因為我們認為我們有一個強勁的第一季度，但這有點我們現在的預期是在全球 10% 到 12% 的範圍內。

Travis, it's Scott. I'll just add to that. Our guidance at the midpoint for Q1 was around 9% growth. That was the $1.41 billion. We beat that by $50 million, almost half of that was surgical. And so it probably would have rounded to low double digits, something like that, if we were to normalize January, but we're getting pretty precise at this point, trying to isolate every single month of the quarter.

特拉維斯，是斯科特。我會補充一點。我們對第一季度中點的指導是增長 9% 左右。那是 14.1 億美元。我們比它多了 5000 萬美元，其中幾乎一半是外科手術。因此，如果我們要使 1 月正常化，它可能會四捨五入到低兩位數，類似的東西，但我們在這一點上變得非常精確，試圖隔離本季度的每個月。

Yes. That's helpful. And I guess the next question would be on the RESILIA rollout, in terms of where you're at in penetration there. And then as you move into 2024, how you're thinking about some of the competitive launches in the U.S.?

是的。這很有幫助。我想下一個問題是關於 RESILIA 的推出，就你在那裡的滲透率而言。然後當你進入 2024 年時，你如何看待在美國推出的一些競爭性產品？

Yes. We're very pleased with how the S3 rollout has gone. We're really following in the footsteps of our surgical franchise. And RESILIA, which is on INSPIRIS and now on MITRIS, has become extremely popular with surgeons. And so we get to follow the legacy that they've really started for us. And we've seen really positive impact from S3 UR. And we expect, by the end of the year that, that's going to be our leading platform in both the U.S. and Europe.

是的。我們對 S3 推出的進展情況感到非常滿意。我們真的在追隨我們外科專營權的腳步。而在 INSPIRIS 和現在在 MITRIS 上的 RESILIA 已經非常受外科醫生的歡迎。因此，我們可以繼承他們真正為我們開創的傳統。我們已經看到 S3 UR 帶來的真正積極影響。我們預計，到今年年底，這將成為我們在美國和歐洲的領先平台。

And remember, we went for a list price increase with that, which is never easy to do. And we've been pretty pleased with how that's gone so far. And I think that just shows that physicians respect and appreciate the value that RESILIA brings to the platform. So we're very encouraged with how the launch has gone to date. We'll continue to roll it out through the rest of the year, but we do expect it to be our leading platform.

請記住，我們為此提高了標價，這絕非易事。我們對到目前為止的進展感到非常滿意。我認為這恰恰表明醫生尊重並欣賞 RESILIA 為平台帶來的價值。因此，我們對迄今為止的發布情況感到非常鼓舞。我們將在今年餘下時間繼續推出它，但我們確實希望它成為我們的領先平台。

I think you had a follow-up question on competitive launches. Is that correct?

我想你有一個關於競爭性發布的後續問題。那是對的嗎？

That's correct, yes.

沒錯，是的。

I mean, competitive launches have been going on for a long time. If we look at Europe, there's a whole complement of products out there. And outside of the #1 and #2, all of the competitors command probably around 15% of the market and that's been fairly stable. So I think for us, it's more about us continuing to innovate and rolling out our leading platforms than it is about anything else.

我的意思是，競爭性發布已經進行了很長時間。如果我們看看歐洲，那裡有完整的產品補充。在#1 和#2 之外，所有競爭對手都佔據了大約 15% 的市場份額，而且這一數字相當穩定。所以我認為對我們來說，更多的是我們繼續創新和推出我們領先的平台，而不是其他任何事情。

Our next question comes from Danielle Antalffy with UBS.

我們的下一個問題來自瑞銀集團的 Danielle Antalffy。

Mike, it may sound like a broken record over here, but it's the end of an era and you definitely will be missed, and it's been such a pleasure being on this journey with you as you had such a meaningful impact on so many patients' lives. So thanks for letting us share that with you.

邁克，這聽起來像是破紀錄，但這是一個時代的終結，你肯定會被懷念，很高興能和你一起踏上這段旅程，因為你對這麼多患者產生瞭如此有意義的影響生活。因此，感謝您讓我們與您分享。

And I guess my first question is on the TAVR growth guidance for the year. And if you look at it from a comp perspective, I mean, Q1 is a tough comp. You guys put up 11% constant currency growth. So I guess I get that we had some sort of backlog work down in January, but I guess my question is, why not a little bit more aggressive on the TAVR growth guidance given the strong Q1 print? Is there anything to consider as it relates to moving through the quarter, as comps actually get easier as we move through the year. So just wondering if you could comment on that. And then I have one quick follow-up.

我想我的第一個問題是關於今年的 TAVR 增長指南。如果你從競爭的角度來看，我的意思是，Q1 是一個艱難的競爭。你們提出了 11% 的持續貨幣增長。所以我想我知道我們在 1 月份有一些積壓工作，但我想我的問題是，鑑於第一季度的強勁表現，為什麼不在 TAVR 增長指導上更積極一點？有什麼需要考慮的，因為它與整個季度有關，因為隨著我們在這一年中的移動，補償實際上變得更容易了。所以只是想知道你是否可以對此發表評論。然後我有一個快速跟進。

Yes. Thanks so much for your nice comment, Danielle. It has been a pleasure for me. Why don't I turn this over to Scott to go through your question?

是的。非常感謝你的好評，丹妮爾。我很高興。為什麼我不把這個交給斯科特來解決你的問題？

Yes. So I mean the short answer is, we did increase the bottom of our range. So we're expecting 10% to 12%, not 9% to 12%. It's not a huge move, but it does indicate that we had a nice January, and we're still positive on the rest of the year. At this point, it's premature to start tinkering any more than that with guidance. We think this is the right modeling assumption for us in that 10% to 12% range for TAVR.

是的。所以我的意思是簡短的回答是，我們確實增加了範圍的底部。所以我們預計是 10% 到 12%，而不是 9% 到 12%。這不是一個巨大的變化，但它確實表明我們在 1 月份過得很愉快，而且我們對今年餘下的時間仍然持樂觀態度。在這一點上，開始修補比指導更多的東西還為時過早。我們認為這是我們在 TAVR 10% 到 12% 範圍內的正確建模假設。

Okay. That's fair. And I think historically, you guys don't tend to raise guidance very aggressively after the first quarter. So that's fair. And a quick question on the TMTT side of things. I know it's very early in the U.S. on PASCAL launching. But Bernard, just curious what you're seeing as it relates to market growth there, and how much you're seeing that market recover? Again, I know you guys are so early, so I'm not sure what you can say, but usually second entry comes to market and markets accelerate in med-tech, but just wondering if we're getting any signs on what market growth could look like going forward there?

好的。這還算公平。而且我認為從歷史上看，你們不會在第一季度後非常積極地提高指導。所以這很公平。還有一個關於 TMTT 方面的快速問題。我知道在美國推出 PASCAL 還為時過早。但是伯納德，只是好奇你所看到的與那裡的市場增長相關的東西，以及你看到市場復甦的程度？再一次，我知道你們來得太早了，所以我不確定你們能說什麼，但通常第二次進入市場，醫療技術市場加速，但我想知道我們是否有任何跡象表明市場增長如何看起來像往前走嗎？

Yes. No, that's a fair question. Indeed, we are pleased about Q1. We have seen some positive signs that the market is recovering. I'm sure you remember that the mitral market during COVID was not growing as expected. And in Q1, we saw that the market was growing again. But again, if you think about the U.S., we are not the share leader, correct? So we look at the market, we see a good sign that it is recovering, and we are very pleased about the introduction of our technology. So the customers are reacting very well to PASCAL PRECISION. They see a differentiated benefit. So we feel good about the impact that we can have here to obviously many patients in need.

是的。不，這是一個公平的問題。事實上，我們對第一季度感到滿意。我們已經看到市場正在復甦的一些積極跡象。我相信您還記得 COVID 期間的二尖瓣市場沒有按預期增長。在第一季度，我們看到市場再次增長。但是再一次，如果你想想美國，我們不是份額領導者，對嗎？所以我們看看市場，我們看到了一個正在復甦的好跡象，我們對引進我們的技術感到非常高興。因此，客戶對 PASCAL PRECISION 的反應非常好。他們看到了差異化的好處。因此，我們對我們可以對許多有需要的患者產生的影響感到滿意。

And our next question comes from Richard Newitter with Truist.

我們的下一個問題來自 Truist 的 Richard Newitter。

So 2 for me. I guess just the first, I know we've talked about hospital staffing. Is that just a catch-all phrase? I know in the past, you said it's the whole workup and everything from getting the patient diagnosed to the entire kind of workup to referral to getting the patient there. So with respect to the improvement that we saw from late last year, just wanted to get a sense for what specifically kind of are you referring to when you say hospital staffing is improving?

所以2對我來說。我想只是第一個，我知道我們已經討論過醫院的人員配備。這只是一個包羅萬象的短語嗎？我知道過去，你說這是整個檢查，從診斷病人到整個檢查到轉診到把病人送到那裡的一切。因此，關於我們從去年年底看到的改善，只是想了解當您說醫院人員配備正在改善時，您具體指的是哪種？

And kind of the second question on that. Just I think you talked about, in the past, a very varied kind of level of recovery across your install base. Any comments you can provide, estimate or characterize kind of where and which types of implanting centers are recovering and at what rate? Or was it just more uniform across the entire install base at this point?

第二個問題。我想你過去曾談到過，在你的安裝基礎上有一種非常不同的恢復水平。您可以提供任何評論、估計或描述植入中心的恢復地點和類型以及恢復速度嗎？還是此時整個安裝基礎更加統一？

Yes. Maybe I'll start and I'll take your second question first because it might take a couple of us to answer your first question. I think we saw the growth being driven more by larger centers than smaller centers during this quarter. And I think this is sort of a trend that we've seen throughout COVID. I think when COVID had spiked, we've seen people stay closer to home, we've seen probably more growth in the smaller centers. And as COVID waned, we see people traveling maybe a little bit further and going to the larger centers. And so I think this is consistent with trends we've seen over the last 1.5 years or so.

是的。也許我會開始，我會先回答你的第二個問題，因為我們可能需要幾個人才能回答你的第一個問題。我認為在本季度，我們看到增長更多地是由較大的中心而不是較小的中心推動的。我認為這是我們在整個 COVID 期間看到的一種趨勢。我認為當 COVID 飆升時，我們看到人們離家更近，我們看到較小的中心可能有更多的增長。隨著 COVID 的減弱，我們看到人們可能會走得更遠一點，去更大的中心。所以我認為這與我們在過去 1.5 年左右看到的趨勢一致。

In terms of when we talk about staffing, it depends when you're talking about our surgical business or our TAVR business. When you talk about the surgical business, it's primarily OR staff and ICU nurses in sort of the post-care initiative. When you're talking about TAVR, there's a lot more that goes into it because there's a lot more upfront workout. So it requires staffing improvements for CT and for angio and sort of the broader cath lab, and we don't need it so much on the aftercare side.

就我們何時談論人員配備而言，這取決於您何時談論我們的外科業務或我們的 TAVR 業務。當你談論外科業務時，它主要是 OR 工作人員和 ICU 護士在某種程度上的後期護理計劃。當您談論 TAVR 時，它涉及的內容更多，因為前期的鍛煉要多得多。因此，它需要改進 CT 和血管造影以及更廣泛的導管實驗室的人員配備，而我們在善後方面並不需要那麼多。

So what I think we've seen just generally, and I think hospital has been working at this for probably better than a year now trying to get people trained and get people in. And remember, you don't just hire a person and then they're effective from day 1. They have to go through a training process with that hospital. But I would say, generally speaking, you can look at the quarter and say, we saw staffing get better and that's reflected in I think our broad performance, but we certainly saw it in TAVR and we certainly saw it with surgical, but it needs to continue to improve over the rest of the year. It's not like we're done yet. But I think hospitals continue to work hard at this.

所以我認為我們一般都看到了什麼，我認為醫院在這方面的工作可能已經超過一年了，現在試圖讓人們接受培訓並讓人們進入。記住，你不只是僱用一個人然後他們從第一天起就有效。他們必須經過那家醫院的培訓過程。但我想說，總的來說，你可以看看這個季度，我們看到人員配備變得更好，這反映在我認為我們的廣泛表現中，但我們肯定在 TAVR 中看到了它，我們當然在外科手術中看到了它，但它需要在今年餘下的時間裡繼續改進。我們還沒有完成。但我認為醫院會繼續努力解決這個問題。

Maybe I'll ask Daveen to comment on the TMTT side what he saw.

也許我會請 Daveen 評論他所看到的 TMTT 方面。

Yes. I mean I think it's a similar kind of comment we made there. Probably all the difference is where there's a lot of people, a lot of different steps that go into a TMTT case. And again, as Bernard said, we are still a minority player here, but we continue to be optimistic that all those different parts of the full patient pathway are continuing to get a little bit better in staffing.

是的。我的意思是我認為這是我們在那裡發表的類似評論。可能所有的區別都在於有很多人，很多不同的步驟進入 TMTT 案例。再一次，正如伯納德所說，我們仍然是這裡的少數參與者，但我們仍然樂觀地認為，整個患者途徑的所有這些不同部分在人員配置方面都在繼續得到改善。

Our next question comes from Matt Miksic with Barclays.

我們的下一個問題來自巴克萊銀行的 Matt Miksic。

So a couple of just quick follow-ups here. So one on the color that you gave on RESILIA. Appreciate the target of kind of getting that to the majority of the U.S. revenues by the end of the year on the TAVR platform, if I understood that correctly. But just broadly, I know you've had a policy of maintaining this kind of set price across your TAVR platform even as you sort of moved it up through the generations of products.

所以這裡有幾個快速跟進。所以一個關於你在 RESILIA 上給的顏色。如果我理解正確的話，請欣賞到年底前在 TAVR 平台上實現美國大部分收入的目標。但從廣義上講，我知道你有一項政策，即在你的 TAVR 平台上保持這種固定價格，即使你在幾代產品中將其提高。

And that is a little bit unusual. Most companies and med devices do tend to sort of contract and rebate and make adjustments to pricing across like particularly in the U.S., given the way DRGs work and different hospitals, nonteaching hospitals get different payments and urban hospitals or hospitals here in New York. And I'm just wondering if having RESILIA in portfolio at a premium, having S3, call it, standard or however you were referring to it in the portfolio, if you're giving any thought into sort of joining the rest of the group to sort of help some of the smaller centers maybe be able to afford to do TAVR when paying for $30,000 or $32,000 for a valve just might be outreach, especially given the way staffing costs have gone up. I'd love to get your thoughts on that. And I have one quick follow-up.

這有點不尋常。考慮到 DRG 的工作方式和不同的醫院、非教學醫院獲得不同的付款以及城市醫院或紐約這裡的醫院，大多數公司和醫療設備確實傾向於簽訂合同和回扣並調整定價，尤其是在美國。而且我只是想知道是否在投資組合中擁有 RESILIA 溢價，擁有 S3，稱它為標準，或者你在投資組合中提到它，如果你正在考慮加入該小組的其他成員在支付 30,000 美元或 32,000 美元的瓣膜費用時，一些較小的中心可能能夠負擔得起 TAVR 的某種幫助可能只是外展，特別是考慮到人員成本上漲的方式。我很想听聽你的想法。我有一個快速跟進。

Sure. Well, we haven't changed really our pricing philosophy. We do try to be good partners with our hospital, and we did take a list price increase, but that's the first price increase we've rolled out really since launch. This is the first time that we've gone through our price increase. And so the other thing that we've always done is we've always rebated based on volume. So large volume centers obviously get discounted out.

當然。好吧，我們並沒有真正改變我們的定價理念。我們確實努力與我們的醫院成為良好的合作夥伴，我們確實提高了標價，但這是自推出以來我們真正推出的第一次價格上漲。這是我們第一次經歷價格上漲。因此，我們一直在做的另一件事是，我們總是根據數量進行回扣。如此大容量的中心顯然會打折。

But we try to treat everybody fairly across the country. And by having that standardized price, that's the way that we try to do that. And then we try to recognize different centers' performance based on their volume and that's been our philosophy throughout. I don't see us changing that philosophy. I think that's worked really well for us, and we do try to work with hospitals and bring a lot of value.

但我們努力在全國范圍內公平對待每個人。通過採用標準化價格，這就是我們嘗試做到這一點的方式。然後我們嘗試根據他們的數量來識別不同中心的性能，這一直是我們的理念。我不認為我們會改變這種理念。我認為這對我們來說非常有效，我們確實嘗試與醫院合作並帶來很多價值。

We still have people supporting virtually every case in the U.S. and the majority of cases in Europe and virtually all the cases in Japan. And that's just sort of the model that we have. And the other thing we try to do is partner with hospitals and run our things like our benchmark program to help them be more efficient.

在美國，我們仍然有人支持幾乎所有案件，在歐洲支持大多數案件，在日本支持幾乎所有案件。這就是我們擁有的模型。我們嘗試做的另一件事是與醫院合作並運行我們的東西，比如我們的基準計劃，以幫助他們提高效率。

But if you look at all the data that's been produced for our clinical trials, this is an incredibly cost-effective procedure with almost unprecedented benefits when you look at mortality and you look at some of the other things that it's done. So we feel the prices that we have are more than fair for the value creation that we have.

但是，如果您查看為我們的臨床試驗生成的所有數據，就會發現這是一種成本效益令人難以置信的程序，當您查看死亡率和它所做的其他一些事情時，它幾乎具有前所未有的好處。因此，我們覺得我們所擁有的價格對於我們所擁有的價值創造來說是非常公平的。

That's fair. And then I guess on the centers have gone more active and staffing pressures have eased a little bit, 1 of the pressure points has been around the extensive imaging and sort of additional sort of staffing, specialized staffing that's required for some of these mitral procedures, TEER procedures. Any thoughts along the same lines of facilitating broader utilization and adoption through partnering with hospitals? Anything that you can see yourself doing to sort of help facilitate those procedures given sort of the specialized staffing needs behind them?

這還算公平。然後我想中心變得更加活躍，人員壓力有所緩解，壓力點之一是廣泛的成像和一些額外的人員配備，其中一些二尖瓣手術所需的專業人員配備， TEER 程序。通過與醫院合作促進更廣泛的使用和採用的相同思路有什麼想法嗎？考慮到這些程序背後的專業人員配置需求，您可以看到自己正在做些什麼來幫助促進這些程序？

Yes, this is Daveen. I mean obviously, I think we're always going to look to partner with hospitals. We're going to look to try to help them across the board. We're obviously in our very early days. We try to provide excellent training, top-notch training to get these patients as efficiently and effectively treated, getting through the recovery process, et cetera. And I think our teams -- since we're a little bit more at the infancy, we don't have the same kind of detailed programs that kind of Larry has, like benchmark, et cetera, in the TAVR program. But we're working really hard to try on the TEER side as well, start creating those as we start getting more scale and being a great partner. I mean, it's a part of it, we all together just want to help more patients together in a cost-effective manner. And that's kind of how we think about it over the long term.

是的，這是戴文。我的意思是很明顯，我認為我們總是會尋求與醫院合作。我們將尋求全面幫助他們。我們顯然還處於早期階段。我們努力提供出色的培訓，一流的培訓，讓這些患者得到高效和有效的治療，完成康復過程，等等。我認為我們的團隊——因為我們還處於起步階段，所以我們沒有像拉里那樣的詳細計劃，比如 TAVR 計劃中的基準等。但我們也非常努力地嘗試在 TEER 方面，隨著我們開始擴大規模並成為一個偉大的合作夥伴，開始創造這些。我的意思是，這是其中的一部分，我們一起只是想以具有成本效益的方式一起幫助更多的患者。從長遠來看，這就是我們對它的看法。

That's fair. And Mike, I have to say it's been something to behold, the culture, the accomplishments of the company. Congrats and you will be missed.

這還算公平。邁克，我不得不說這是值得一看的，公司的文化和成就。恭喜你，你會被想念的。

Thank you, Matt.

謝謝你，馬特。

Our next question comes from Cecilia Furlong with Morgan Stanley.

我們的下一個問題來自摩根士丹利的 Cecilia Furlong。

I wanted to return to Japan some of the comments that you called out just around competitive trialing, how you would frame Edwards growth there versus the market understanding still we're seeing recovery in the region? And then looking forward to really what's reflected in guidance from Japan recovery at this point as well as Ultra RESILIA rollout?

我想回到日本，你在競爭性試驗中提出的一些評論，你如何看待 Edwards 在那裡的增長與我們仍然看到該地區復甦的市場理解？然後期待此時日本複甦的指導以及 Ultra RESILIA 的推出真的反映了什麼？

So, Cecilia, this is Mike. Can you just zoom in a little bit on the first part of that question again? I want to make sure that I understand it.

所以，塞西莉亞，這是邁克。你能再放大一點那個問題的第一部分嗎？我想確保我理解它。

You talked a bit about competitive dynamics you were seeing in the region, I believe. So just curious if you could provide a little more detail, just how that impacted your growth versus market growth.

我相信，您談到了您在該地區看到的競爭動態。所以很好奇你是否可以提供更多細節，這如何影響你的增長與市場增長。

Yes. So we had 2 of our -- the 2 other competitors in Japan, both rolled out new products. And so it's not uncommon when new products roll out that we see physicians trying those products and understanding how they work and what the features and benefits are. And I think we've seen this throughout our history and usually that ends up being largely transient. And we're excited because we're just getting ready to do our biggest launch we've done in Japan since our initial launch, which is S3 UR. And so we're excited about that.

是的。所以我們有兩個——日本的另外兩個競爭對手，都推出了新產品。因此，當新產品推出時，我們經常會看到醫生嘗試這些產品並了解它們的工作原理以及特性和優勢。而且我認為我們在整個歷史中都看到了這一點，而且通常最終在很大程度上是短暫的。我們很興奮，因為我們剛剛準備好進行自首次發布以來在日本進行的最大發布，即 S3 UR。所以我們對此感到興奮。

I think broader what's in the guidance for Japan is we're expecting a broader COVID recovery. COVID was still pretty big in Q1 and we're looking for a broader COVID recovery and continued uptake. It got better during the quarter, but we're looking forward to continue to improve throughout the year and that's what's in our guidance.

我認為更廣泛的內容是日本的指導方針是我們期待更廣泛的 COVID 復甦。 COVID 在第一季度仍然很大，我們正在尋找更廣泛的 COVID 恢復和持續吸收。本季度情況有所好轉，但我們期待全年繼續改善，這就是我們的指導方針。

Yes. The only thing I'd add to it is Japan has been a pretty strong grower for us over the last couple of years and then really slowed down when COVID hit in the second half of last year. So we're looking forward here, especially with COVID waning and the launch of SAPIEN Ultra RESILIA, it's really going to make a difference starting in Q2 and moving forward.

是的。我唯一要補充的是，日本在過去幾年中對我們來說一直是一個非常強勁的增長者，然後在去年下半年 COVID 來襲時真正放緩。所以我們在這裡期待，特別是隨著 COVID 的減弱和 SAPIEN Ultra RESILIA 的推出，它真的會從第二季度開始並向前發展。

Thank you. And ladies and gentlemen, we have time for one final question before turning it over to management for some closing remarks. And that question comes from Josh Jennings with TD Cowen.

謝謝。女士們，先生們，我們有時間提出最後一個問題，然後再交給管理層做一些結束語。這個問題來自 TD Cowen 的 Josh Jennings。

Mike, really appreciate all your insights on these 92 earnings calls and I have been on half of them. But a question really, I mean, for Larry. Just wanted to -- we're getting questions on the TAVR-in-TAVR replacement cycle. I'm wondering if you could just size up the percentage of the market currently that TAVR-in-TAVR represents. And I imagine it becomes a bigger, more meaningful piece as you get out to 2028 and that $10 billion market that you guys have forecasted, but when do we start to think about TAVR-in-TAVR contributing more meaningfully to market growth.

邁克，非常感謝你對這 92 次財報電話會議的所有見解，我參加了其中一半。但是，我的意思是，對於拉里來說，這是一個真正的問題。只是想——我們收到了關於 TAVR-in-TAVR 更換週期的問題。我想知道您是否可以估計目前 TAVR-in-TAVR 所代表的市場百分比。我想，到 2028 年和你們預測的 100 億美元市場時，它會變得更大、更有意義，但是我們什麼時候開始考慮 TAVR-in-TAVR 對市場增長做出更有意義的貢獻。

Yes. No, it's a good question. I don't know that I can quantify it for you today. But we do TAVR-in-TAVR. But we also do TAVR-in-SAVR for patients that have gotten tissue valves. But I think one of the things that TAVR enabled with its development was the opportunity for more patients to get tissue valves. So even on the surgical side of our business, younger patients can get tissue valves now because physicians and patients know if they outlive their valve, that there is a catheter-based option for them down the road. So certainly, in time, TAVR-in-SAVR will continue to grow and TAVR-in-TAVR will become a bigger part. TAVR valves now are just probably starting to get to the cusp of reaching that age that, that will start to be more meaningful, but it will be something that grows in time, certainly as we look at the period that you discussed, which is through 2028.

是的。不，這是個好問題。不知道今天能不能量化給大家。但我們做 TAVR-in-TAVR。但我們也為獲得組織瓣膜的患者進行 TAVR-in-SAVR。但我認為 TAVR 的發展帶來的其中一件事是讓更多患者有機會獲得組織瓣膜。因此，即使在我們業務的外科手術方面，年輕患者現在也可以獲得組織瓣膜，因為醫生和患者都知道，如果他們的瓣膜壽命比他們長，那麼在未來會有基於導管的選擇。因此，當然，隨著時間的推移，TAVR-in-SAVR 將繼續增長，TAVR-in-TAVR 將成為更大的一部分。 TAVR 瓣膜現在可能剛剛開始達到那個年齡的風口浪尖，那將開始變得更有意義，但它會隨著時間的推移而增長，當然正如我們所討論的時期一樣，通過2028.

Okay. Well, this is Mike. I would make some closing comments. First of all, thank you so much for many of your warm remarks. It's been a special honor and a privilege to lead our team at Edwards Lifesciences for more than 20 years. And I really want to thank our employees who have made immense contributions to advancing care and helping millions of patients around the world. I'm particularly proud of our patients first culture and our commitment to innovation and excellence.

好的。嗯，這是邁克。我會做一些結束語。首先，非常感謝您的許多熱情洋溢的評論。在 Edwards Lifesciences 領導我們的團隊 20 多年是一種特殊的榮譽和特權。我真的要感謝我們的員工，他們為推進護理和幫助全球數百萬患者做出了巨大貢獻。我為我們的患者至上文化以及我們對創新和卓越的承諾感到特別自豪。

Our success is really a testament to the talented and passionate executive leadership team and our employees worldwide, and I believe we are well-positioned for an even brighter future. It's truly been my greatest honor to be Edwards CEO, and I look forward to supporting Edwards as I transition to my new role with the Board of Directors. So thanks a lot for your continued interest in Edwards, and the team will welcome any additional questions after the call.

我們的成功確實證明了我們才華橫溢、充滿激情的執行領導團隊和我們在全球的員工，我相信我們已經做好準備迎接更加光明的未來。成為 Edwards 的首席執行官真的是我最大的榮幸，我期待在我向董事會新角色過渡時支持 Edwards。非常感謝您對 Edwards 的持續關注，團隊將歡迎您在電話會議後提出任何其他問題。

Thank you. And with that, we conclude today's conference. All parties may disconnect. Have a great evening.

謝謝。至此，我們結束今天的會議。各方可能會斷開連接。祝你有個愉快的夜晚。