愛德華生命科學 (EW) 2020 Q4 法說會逐字稿

Greetings, and welcome to the Edwards Lifesciences Corporation Fourth Quarter 2020 Results Conference Call. (Operator Instructions) Please note that this conference is being recorded.

您好，歡迎來到 Edwards Lifesciences Corporation 2020 年第四季度業績電話會議。（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, Vice President of Investor Relations. Thank you. You may begin.

我現在將會議轉交給我們的主持人，投資者關係副總裁 Mark Wilterding。謝謝。你可以開始了。

Thanks, Diego.

謝謝，迭戈。

Good afternoon, and thank you for joining us, everyone. With me on today's call are Mike Mussallem, Chairman and Chief Executive Officer; and Scott Ullem, Chief Financial Officer.

下午好，感謝大家加入我們。與我一起出席今天電話會議的有董事長兼首席執行官 Mike Mussallem；和首席財務官 Scott Ullem。

Just after the close of regular trading, Edwards Lifesciences released fourth quarter 2020 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 2020 年第四季度財務業績。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 when they were made, and Edwards does not take -- 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。這些聲明僅說明它們作出之日的情況，Edwards 不承擔任何在今天之後更新它們的義務。

Additionally, the statements involve risks and uncertainties, including, but not limited to, those associated with the pandemic 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 2019 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，這些陳述涉及風險和不確定性，包括但不限於與大流行相關的風險和不確定性，這些風險和不確定性可能導致實際結果存在重大差異。有關可能導致這些差異的因素的信息和重要的安全信息可以在新聞稿、我們 10-K 表格的 2019 年年度報告和 Edwards 的其他 SEC 文件中找到，所有這些都可以在公司網站 edwards.com 上找到。

Finally, a quick reminder that when using the terms underlying 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，在使用基礎和調整後的術語時，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.

謝謝你，馬克。

Before we discuss fourth quarter results and our expectations for 2021 and beyond, I want to spend a minute reflecting on 2020. Structural heart patients were severely impacted beginning in March, experiencing significant difficulties entering the system, which also had a profound impact on second quarter procedures. And even though health care systems adapted to the challenge, the resurgence of COVID that began late in the year continues to impact structural heart patients who need care.

在我們討論第四季度業績和我們對 2021 年及以後的預期之前，我想花一點時間回顧一下 2020 年。從 3 月開始，結構性心髒病患者受到嚴重影響，進入系統時遇到很大困難，這也對第二季度的程序產生了深遠影響。儘管醫療保健系統適應了挑戰，但從今年年底開始的 COVID 捲土重來繼續影響需要護理的結構性心髒病患者。

Despite unprecedented challenges throughout the year, I'm proud of our team's steadfast dedication to our patient-focused strategy. We continue to invest in developing solutions that extend lives, improve the quality of life and offer greater value for the health care system.

儘管全年面臨前所未有的挑戰，但我為我們的團隊堅定不移地致力於以患者為中心的戰略感到自豪。我們繼續投資開發延長壽命、提高生活質量並為醫療保健系統提供更大價值的解決方案。

Along those lines, we celebrated some exciting milestones in 2020 that directly impacted patients. In TAVR, despite headwinds, more than 100,000 patients benefited from treatment with SAPIEN valves worldwide. In Surgical Structural Heart, we launched our KONECT aortic valve conduit, and INSPIRIS became the leading aortic surgical valve worldwide. We've seen early positive clinical evidence across the TMTT platform. Physician feedback is encouraging, and patient outcomes have been distinguished. And in Critical Care, we met the increased demand for core pressure monitoring products due to the pandemic, and we're proud that we are able to help over 1 million COVID patients globally with our monitoring technology.

沿著這些思路，我們在 2020 年慶祝了一些直接影響患者的激動人心的里程碑。在 TAVR 中，儘管有不利因素，但全球有超過 100,000 名患者受益於 SAPIEN 瓣膜治療。在 Surgical Structural Heart 領域，我們推出了 KONECT 主動脈瓣導管，INSPIRIS 成為全球領先的主動脈手術瓣膜。我們已經在 TMTT 平台上看到了早期積極的臨床證據。醫生的反饋令人鼓舞，患者的治療效果也很出色。在重症監護方面，我們滿足了因大流行而對核心壓力監測產品不斷增長的需求，我們很自豪能夠利用我們的監測技術幫助全球超過 100 萬 COVID 患者。

To support our innovation and growth, we continued to invest in our people and our infrastructure. During a year when job losses impacted many families across the globe, Edwards prioritized protecting our employees, and we grew our team to 15,000 worldwide. We continue to make strategic R&D investments that enabled us to fuel progress. And despite this unique environment and extraordinary prior year growth, underlying sales grew 1% in 2020 to $4.4 billion, which is a reflection of the life-threatening needs of the patients that Edwards serves.

為了支持我們的創新和發展，我們繼續投資於我們的員工和基礎設施。在失業影響到全球許多家庭的一年中，Edwards 將保護我們的員工放在首位，我們的團隊在全球範圍內擴大到 15,000 人。我們繼續進行戰略研發投資，使我們能夠推動進步。儘管存在這種獨特的環境和上一年的非凡增長，但 2020 年的基本銷售額增長了 1%，達到 44 億美元，這反映了 Edwards 所服務的患者的危及生命的需求。

Looking into 2021, while we expect the pandemic to continue to impact the global health care system, we remain optimistic about the year ahead. As we indicated at our investor conference, we expect full year sales between $4.9 billion and $5.3 billion, representing mid-teens underlying growth on a year-over-year basis. Based on our year-to-date experience, we expect Q1 sales to be slightly down sequentially, although in line with the first quarter of last year, which was largely unaffected by COVID.

展望 2021 年，雖然我們預計疫情將繼續影響全球醫療保健系統，但我們對未來一年仍持樂觀態度。正如我們在投資者會議上指出的那樣，我們預計全年銷售額在 49 億美元至 53 億美元之間，與去年同期相比基礎增長達到中等水平。根據我們年初至今的經驗，我們預計第一季度的銷售額將略有下降，但與去年第一季度基本一致，而去年第一季度基本上沒有受到 COVID 的影響。

Our 2021 guidance continues to assume COVID will stress the global health care system at least through the winter months with procedures ramping later in the year. This expectation assumes that vaccines are effective and widely administered by midyear 2021 and hospitals continue to improve their ability to treat non-COVID patients who need care for conditions such as aortic stenosis. And even though we expect the COVID impact on sales at the start of the year, we are continuing to invest now in our innovations that have the tremendous opportunity to enhance patients' lives and bring significant value to the health care system.

我們的 2021 年指南繼續假設 COVID 將至少在整個冬季給全球醫療保健系統帶來壓力，並在今年晚些時候增加程序。這一預期假設疫苗在 2021 年年中之前有效並廣泛使用，並且醫院繼續提高其治療因主動脈瓣狹窄等疾病需要護理的非 COVID 患者的能力。儘管我們預計 COVID 會在年初對銷售產生影響，但我們現在仍在繼續投資於我們的創新，這些創新有巨大的機會來改善患者的生活並為醫療保健系統帶來重大價值。

We recognize the uncertain impact and time frame for recovery from this unique global challenge, but we remain confident that our patient-focused strategy of continued investment positions us well and even stronger when the world emerges from the pandemic.

我們認識到從這一獨特的全球挑戰中恢復的不確定影響和時間框架，但我們仍然相信，當世界擺脫大流行時，我們以患者為中心的持續投資戰略將使我們處於有利地位，甚至更加強大。

Now turning to our quarterly results. Consistent with our guidance at our investor conference last month, fourth quarter sales of $1.2 billion were in line with the year ago period when Edwards grew nearly 20% on an underlying basis reflecting the strength even during the ongoing pandemic. Full year 2020 global sales -- global TAVR sales of $2.9 billion increased 4% on an underlying basis over the prior year. 2020 growth reflected increased sales in every region, lifted by greater awareness of the benefits of TAVR therapy and increased adoption of our leading technologies.

現在轉向我們的季度業績。與我們在上個月的投資者會議上的指導一致，第四季度銷售額為 12 億美元，與去年同期持平，當時 Edwards 基本增長近 20%，反映了即使在持續的大流行期間的實力。2020 年全年全球銷售額——全球 TAVR 銷售額為 29 億美元，同比增長 4%。2020 年的增長反映了每個地區的銷售額增長，這得益於對 TAVR 療法好處的認識提高以及我們領先技術的採用率提高。

Based on the strength of the SAPIEN platform, we retained our strong leadership position while also maintaining our disciplined price strategy. In the fourth quarter, global TAVR sales were $776 million, up slightly from the year ago period. We estimate global TAVR procedure growth was comparable with our growth. And globally, average selling prices were stable.

基於 SAPIEN 平台的優勢，我們保持了強大的領導地位，同時也保持了我們嚴格的價格策略。第四季度，全球 TAVR 銷售額為 7.76 億美元，同比略有增長。我們估計全球 TAVR 程序的增長與我們的增長相當。在全球範圍內，平均售價穩定。

Although the rollout was somewhat impacted, SAPIEN 3 Ultra now represents more than 2/3 of our global TAVR sales, and physician feedback on ease-of-use and improved paravalvular leak performance remains outstanding. In the U.S., our Q4 TAVR sales were approximately level with the third quarter and declined in the mid-single-digit range versus last year. We estimate overall Q4 U.S. procedures declined at a comparable rate. Recall that our U.S. TAVR sales in the year ago period increased nearly 40%, driven by the strong PARTNER III evidence that led to a third quarter 2019 indication expansion and improved patient access under an updated TAVR NCD. We expect these factors to resume lifting treatment rates as the pandemic subsides.

儘管推出受到一定影響，但 SAPIEN 3 Ultra 現在占我們全球 TAVR 銷售額的 2/3 以上，醫生對易用性和改進的瓣週漏性能的反饋仍然很突出。在美國，我們第四季度的 TAVR 銷售額與第三季度大致持平，與去年相比下降了中個位數範圍。我們估計美國第四季度的整體程序以可比的速度下降。回想一下，我們去年同期在美國的 TAVR 銷售額增長了近 40%，這得益於強有力的 PARTNER III 證據，該證據導致 2019 年第三季度的適應症擴大並改善了更新後的 TAVR NCD 下的患者獲取。我們預計隨著大流行消退，這些因素將恢復提高治療率。

Growth at smaller TAVR centers, which are providing local access to aortic stenosis patients was more than offset by declines in larger accounts where referrals have been disrupted by the resurgence of COVID. Outside the U.S., in the fourth quarter, we estimated total TAVR procedures grew in the high single digits on a year-over-year basis, and Edwards' growth was comparable. Edwards underlying TAVR growth in Europe versus the prior year was in the mid-single-digit range. Growth was driven by continued strong adoption of our SAPIEN platform and was more pronounced in countries that were more severely impacted by the first wave of COVID in 2020.

較小的 TAVR 中心為主動脈瓣狹窄患者提供本地通道，其增長被大客戶的下降所抵消，大客戶的轉診因 COVID 的捲土重來而中斷。在美國以外，在第四季度，我們估計 TAVR 手術總數同比增長了高個位數，與 Edwards 的增長相當。與上一年相比，愛德華茲在歐洲的潛在 TAVR 增長處於中等個位數範圍內。增長是由我們的 SAPIEN 平台的持續強勁採用所推動的，並且在 2020 年受到第一波 COVID 浪潮影響更嚴重的國家中更為明顯。

Outside of the U.S. and Europe, we continue to see very good TAVR adoption in the fourth quarter. Sales growth in Japan, Australia and Korea were strong where therapy adoption is still low. In Japan, we continue to anticipate providing SAPIEN 3 for low-risk patients prior to the end of this year. In China, which was a minor contributor to Q4 sales, we remain focused on growing our dedicated clinical support team to assist leading hospitals as they build their TAVR programs.

在美國和歐洲之外，我們繼續看到第四季度 TAVR 的採用情況非常好。日本、澳大利亞和韓國的銷售額增長強勁，而這些國家的治療採用率仍然很低。在日本，我們繼續預計在今年年底之前為低風險患者提供 SAPIEN 3。中國是第四季度銷售額的次要貢獻者，我們仍然專注於發展我們專門的臨床支持團隊，以協助領先醫院建立他們的 TAVR 項目。

In addition to geographic expansion of our TAVR therapies, we remain focused on indication expansion. We talked at our recent investor conference about our EARLY-TAVR Trial, which is focused on the treatment of asymptomatic patients. Enrollment is now 2/3 complete, and we remain optimistic that the trial will be fully enrolled in 2021.

除了我們的 TAVR 療法的地理擴張外，我們仍然專注於適應症擴張。我們在最近的投資者會議上談到了我們的 EARLY-TAVR 試驗，該試驗專注於無症狀患者的治療。註冊現已完成 2/3，我們仍然樂觀地認為該試驗將在 2021 年全部註冊。

Separately, we continue to plan to initiate an important pivotal trial for moderate aortic stenosis to determine the optimal time to treat patients who have this progressive disease. We believe that some patients may benefit from earlier treatment when they have moderate AS rather than risking irreversible damage as the disease progresses. We're optimistic about the potential of this trial, and we anticipate FDA approval to begin enrollment this year.

另外，我們繼續計劃啟動一項針對中度主動脈瓣狹窄的重要關鍵試驗，以確定治療患有這種進行性疾病的患者的最佳時間。我們認為，一些患者在患有中度 AS 時可能會從早期治療中獲益，而不是隨著疾病的進展而冒著不可逆轉的損害的風險。我們對這項試驗的潛力持樂觀態度，我們預計 FDA 批准今年開始註冊。

In November 2020, we were pleased that the American Heart Association announced the launch of an initiative called Target: Aortic Stenosis, a quality improvement program aimed to develop optimal standards of care. The program features a learning collaborative comprised of experts and volunteers from pilot hospital locations around the nation. AHA noticed that if left untreated, the condition worsens, and patients with severe aortic stenosis have a survival rate as low as 50% at 2 years. Aortic stenosis is also a risk factor for heart failure, a costly disease projected to cost the U.S. health care system $70 billion in 2030.

2020 年 11 月，我們很高興美國心臟協會宣布啟動一項名為“目標：主動脈瓣狹窄”的計劃，這是一項旨在製定最佳護理標準的質量改進計劃。該計劃的特色是學習協作，由來自全國試點醫院地點的專家和志願者組成。AHA 注意到，如果不及時治療，病情會惡化，嚴重主動脈瓣狹窄患者的 2 年生存率低至 50%。主動脈瓣狹窄也是心力衰竭的一個危險因素，心力衰竭是一種代價高昂的疾病，預計到 2030 年美國醫療保健系統將花費 700 億美元。

In summary, we continue to anticipate 2021 underlying TAVR sales growth in the 15% to 20% range as we shared at our investor conference. We expect continuing COVID-related challenges early in 2021, turning to a more normalized growth environment in the second half of the year. We remain confident this large global opportunity will exceed $7 billion by 2024, which implies a compounded annual growth rate in the low double-digit range.

總之，正如我們在投資者會議上分享的那樣，我們繼續預計 2021 年基本 TAVR 銷售額將增長 15% 至 20%。我們預計 2021 年初將繼續面臨與 COVID 相關的挑戰，並在下半年轉向更加正常的增長環境。我們仍然相信，到 2024 年，這一巨大的全球機遇將超過 70 億美元，這意味著複合年增長率將處於較低的兩位數範圍內。

Turning to transcatheter mitral and tricuspid therapies, or TMTT. We've made meaningful progress moving from early-stage development to clinical use across all of our platforms with over 3,000 patients treated to date. To transform treatment and unlock the significant long-term growth opportunity, we remain focused on 3 key value drivers: a portfolio of differentiated therapies, positive pivotal trial results to support approvals and adoption and favorable real-world clinical outcomes.

轉向經導管二尖瓣和三尖瓣治療，或 TMTT。從早期開發到臨床使用，我們在所有平台上取得了有意義的進展，迄今為止已有超過 3,000 名患者接受了治療。為了轉變治療方法並釋放重要的長期增長機會，我們仍然專注於 3 個關鍵價值驅動因素：差異化療法組合、支持批准和採用的積極關鍵試驗結果以及有利的現實世界臨床結果。

In Europe, PASCAL leaflet repair continues to deliver excellent results. In Q4, we continued the introduction of PASCAL ACE for mitral and tricuspid patients, and we're pleased with the early real-world results and positive physician feedback regarding its differentiated features and narrower profile. We plan to make both PASCAL ACE and PASCAL available on a single next-generation platform called the PASCAL Precision System. This new system is designed to elevate the user experience with enhanced maneuverability, navigation and stability, enabling improved procedural precision.

在歐洲，PASCAL 小葉修復繼續提供出色的結果。在第四季度，我們繼續為二尖瓣和三尖瓣患者引入 PASCAL ACE ，我們對早期的真實世界結果和醫生對其差異化特徵和更窄輪廓的積極反饋感到滿意。我們計劃在稱為 PASCAL Precision System 的單一下一代平台上提供 PASCAL ACE 和 PASCAL。這個新系統旨在通過增強的機動性、導航性和穩定性來提升用戶體驗，從而提高程序精度。

From a clinical perspective, in this challenging near-term environment, we are experiencing a negative impact to clinical trial enrollment. However, our team and research partners are highly motivated to build on the differentiated data presented in 2020 and expand our body of clinical evidence in this exciting field. We will look forward to presenting meaningful follow-up data across our portfolio at medical meetings later this year.

從臨床角度來看，在這個充滿挑戰的近期環境中，我們正在經歷對臨床試驗註冊的負面影響。然而，我們的團隊和研究合作夥伴非常積極地在 2020 年提供的差異化數據的基礎上進一步擴展我們在這個激動人心的領域中的臨床證據。我們期待在今年晚些時候的醫學會議上展示我們產品組合中有意義的後續數據。

We progressed in the enrollment of our 3 CLASP pivotal studies. We also received approval for use of the Edwards PASCAL Precision System in these pivotal studies. The company still expects U.S. approval of PASCAL for patients with DMR late next year. We continue enrolling SAPIEN M3 pivotal study, ENCIRCLE, designed to demonstrate strong safety and efficacy for transcatheter mitral replacement, and we're on track to initiate our first clinical experience with our next-generation EVOQUE mitral replacement system. The EVOQUE tricuspid replacement study, TRISCEND, continued to enroll in Q4, and we're on track to initiate the TRISCEND II randomized pivotal study based on FDA's breakthrough pathway designation. We look forward to bringing this important treatment option to more patients that are in significant need.

我們在 3 項 CLASP 關鍵研究的招募方面取得了進展。我們還獲准在這些關鍵研究中使用 Edwards PASCAL 精密系統。該公司仍預計美國將在明年底批准 PASCAL 用於 DMR 患者。我們繼續招募 SAPIEN M3 關鍵研究 ENCIRCLE，該研究旨在證明經導管二尖瓣置換術的強大安全性和有效性，我們正按計劃啟動我們的下一代 EVOQUE 二尖瓣置換系統的首次臨床體驗。EVOQUE 三尖瓣置換研究 TRISCEND 繼續在第四季度註冊，我們正按計劃啟動基於 FDA 突破性途徑指定的 TRISCEND II 隨機關鍵研究。我們期待將這一重要的治療選擇帶給更多急需治療的患者。

Turning to recent news. We commend CMS for ensuring mitral valve disease patients have improved access to therapy options through the updated NCD. This update, which includes coverage with evidence development, achieves the balance of patient access with high-quality outcomes.

轉向最近的新聞。我們讚揚 CMS 確保二尖瓣疾病患者通過更新的 NCD 改善了治療選擇。此更新包括證據開發的覆蓋範圍，實現了患者可及性和高質量結果的平衡。

Fourth quarter global sales were $13 million, representing sequential improvement versus Q3. Full year 2020 sales were $42 million. We expect continuing COVID-related challenges early in 2021, but we anticipate a ramp-up through the rest of the year. We maintain our belief that the total TMTT sales will approximately double in 2021. We continue to estimate the global TMTT opportunity to reach $3 billion by 2025, with significant growth beyond. We remain committed to transforming the treatment of these patients and believe our portfolio strategy positions us well for ultimate leadership.

第四季度全球銷售額為 1300 萬美元，較第三季度有所改善。2020 年全年銷售額為 4200 萬美元。我們預計 2021 年初將繼續面臨與 COVID 相關的挑戰，但我們預計在今年餘下時間裡挑戰會加劇。我們仍然相信 TMTT 的總銷售額將在 2021 年翻一番。我們繼續估計到 2025 年全球 TMTT 機會將達到 30 億美元，並在以後有顯著增長。我們仍然致力於改變這些患者的治療方式，並相信我們的投資組合戰略使我們能夠成為最終的領導者。

In Surgical Structural Heart, full year 2020 global sales of $762 million decreased 10% on an underlying basis over the prior year, in line of our guidance -- with our guidance of 5% to 15% decline. Fourth quarter sales of $204 million held steady with Q3 and declined 2% year-over-year on an underlying basis, which was below our previous expectation for positive growth.

在 Surgical Structural Heart 方面，2020 年全年全球銷售額為 7.62 億美元，比上年下降 10%，這與我們的指導一致——我們的指導是下降 5% 至 15%。第四季度銷售額為 2.04 億美元，與第三季度持平，基本同比下降 2%，低於我們此前預期的正增長。

Over the course of the quarter, hospitals experienced an influx of COVID patients limiting surgical procedures. Despite this impact, we are encouraged that the U.S. achieved positive growth in Q4 driven by adoption of our newest premium technologies. We remain very encouraged by the steady global adoption of Edwards premium RESILIA tissue valves, including the INSPIRIS aortic surgical valve and the recently launched KONECT aortic valve conduit. In the fourth quarter, INSPIRIS valve utilization grew in all regions, and we continue to add new centers.

在本季度的過程中，醫院經歷了 COVID 患者的湧入，限制了手術程序。儘管存在這種影響，但令我們感到鼓舞的是，在採用我們最新的優質技術的推動下，美國在第四季度實現了正增長。我們對 Edwards 優質 RESILIA 組織瓣膜在全球範圍內的穩定採用感到非常鼓舞，包括 INSPIRIS 主動脈手術瓣膜和最近推出的 KONECT 主動脈瓣導管。第四季度，INSPIRIS 閥門在所有地區的使用率都有所增長，並且我們繼續增加新的中心。

Sales in the U.S. are ramping for KONECT, the first preassembled ready-to-implant aortic tissue valve conduit for patients who require replacement of the aortic valve, root and ascending aorta, which is a critical unmet patient need. We continue to focus on comprehensive physician training and robust data collection for the HARPOON beating heart mitral valve repair system. We are seeing favorable patient outcomes, with faster surgery and recovery times with this minimally invasive therapy. The U.S. pivotal trial is now underway, and the first patient was treated in December.

KONECT 在美國的銷量正在攀升，這是第一個預組裝的準備植入的主動脈組織瓣膜導管，適用於需要更換主動脈瓣、根部和升主動脈的患者，這是未滿足的關鍵患者需求。我們繼續專注於為 HARPOON 跳動心臟二尖瓣修復系統提供全面的醫師培訓和可靠的數據收集。我們看到了有利的患者結果，這種微創療法的手術和恢復時間更快。美國的關鍵試驗正在進行中，第一位患者已於 12 月接受治療。

In summary, we expect full year 2021 underlying sales growth in the high single-digit range for Surgical Structural Heart, driven by market adoption of our newest technologies. After a challenging start, we expect improving year-over-year comparisons as we progress through the year. We are excited by our ability to provide innovative surgical treatment options for more patients and to extend our global leadership in premium surgical structural heart technologies. We believe the current $1.8 billion Surgical Structural Heart opportunity will grow mid-single digits through 2026.

總之，在市場採用我們最新技術的推動下，我們預計 2021 年全年 Surgical Structural Heart 的基本銷售額將實現高個位數增長。在經歷了一個充滿挑戰的開端之後，我們預計隨著我們在這一年中的進步，我們的年度比較會有所改善。我們很高興能夠為更多患者提供創新的手術治療方案，並擴大我們在優質手術結構性心臟技術方面的全球領導地位。我們相信，到 2026 年，目前價值 18 億美元的外科結構心臟機會將增長到中等個位數。

In Critical Care, full year 2020 global sales of $725 million decreased 3% on an underlying basis versus the prior year, in line with our guidance of flat to down 5%. Fourth quarter Critical Care sales of $198 million decreased 2% on an underlying basis, driven by the decline in HemoSphere orders in the U.S. as hospitals limited their capital spending. Sales of our TruWave disposable pressure monitoring devices used in the ICU were lifted by the increased COVID hospitalizations late in the fourth quarter in both the U.S. and Europe. Demand for our products used in more intense surgeries remained strong, but were more than offset by the impact of delayed elective procedures.

在重症監護方面，2020 年全年全球銷售額為 7.25 億美元，同比下降 3%，符合我們持平至下降 5% 的指引。第四季度重症監護銷售額為 1.98 億美元，基本下降 2%，這是由於醫院限制資本支出導緻美國 HemoSphere 訂單下降所致。我們在 ICU 中使用的 TruWave 一次性壓力監測設備的銷量因第四季度末美國和歐洲 COVID 住院人數的增加而增加。對我們用於高強度手術的產品的需求依然強勁，但被延遲的擇期手術的影響所抵消。

In summary, we expect full year 2021 underlying sales growth in the high single-digit range for critical care. 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 for their patients.

總之，我們預計 2021 年全年重症監護的基礎銷售額將實現高個位數增長。隨著我們繼續將重點轉移到旨在幫助臨床醫生為患者做出更好決策的智能康復技術，我們仍然對我們的重症監護創新管道感到興奮。

Now I'll ask Scott to provide some more detail on the company's financial results.

現在，我將請 Scott 提供有關公司財務業績的更多詳細信息。

Hey. Thanks a lot, Mike.

嘿。非常感謝，邁克。

Today, I'll provide a wrap-up of 2020 including detailed results from the fourth quarter as well as provide an update on guidance for the first quarter and full year of 2021.

今天，我將提供 2020 年的總結，包括第四季度的詳細結果，並提供 2021 年第一季度和全年指導的最新情況。

Despite the wave of COVID that began during the fourth quarter, we are pleased that we were able to achieve our sales guidance ranges across all product lines. Sales in the fourth quarter were flat year-over-year on an underlying basis, and adjusted earnings per share grew 2% to $0.50 versus the prior year. GAAP earnings per share was similar at $0.49. For the full year 2020, sales increased 1% on an underlying basis to $4.4 billion. Adjusted earnings per share was flat at $1.86, and we generated over $700 million of adjusted free cash flow.

儘管 COVID 浪潮始於第四季度，但我們很高興能夠實現所有產品線的銷售指導範圍。第四季度銷售額基本同比持平，調整後每股收益同比增長 2% 至 0.50 美元。GAAP 每股收益相似，為 0.49 美元。2020 年全年銷售額基本增長 1% 至 44 億美元。調整後每股收益持平於 1.86 美元，我們產生了超過 7 億美元的調整後自由現金流。

During 2020, we achieved cost efficiencies, but we intentionally did not take any actions to significantly impact our employees or reduce investments supporting our long-term strategy.

2020 年，我們實現了成本效益，但我們有意沒有採取任何行動來顯著影響我們的員工或減少支持我們長期戰略的投資。

I'll now cover the details of our results and then discuss guidance for 2021. For the fourth quarter, our adjusted gross profit margin was 75.3% compared to 75.8% in the same period last year. This reduction was driven by a negative impact from foreign exchange and incremental costs associated with responding to COVID partially offset by lower performance-based compensation. We continue to expect our 2021 adjusted gross profit margin to be between 76% and 77%. Our rate should be lifted by an improved product mix, partially offset by a negative impact from foreign exchange.

我現在將詳細介紹我們的結果，然後討論 2021 年的指導方針。第四季度，我們調整後的毛利率為 75.3%，而去年同期為 75.8%。這種減少是由於外彙的負面影響和與應對 COVID 相關的增量成本被較低的基於績效的薪酬部分抵消。我們繼續預計 2021 年調整後的毛利率將在 76% 至 77% 之間。我們的利率應該通過改善產品組合來提高，部分被外彙的負面影響所抵消。

Selling, general and administrative expenses in the fourth quarter were $339 million or 28.4% of sales compared to $347 million in the prior year. This decrease was primarily driven by reduced spending resulting from COVID and lower performance-based compensation, partially offset by the impact from foreign exchange. We continue to expect full year 2021 SG&A as a percentage of sales, excluding special items, to be 28% to 29%, which is similar to pre-COVID levels.

第四季度的銷售、一般和管理費用為 3.39 億美元，佔銷售額的 28.4%，而去年同期為 3.47 億美元。這一下降主要是由於 COVID 導致的支出減少和基於績效的薪酬減少，部分被外彙的影響所抵消。我們繼續預計 2021 年全年 SG&A 佔銷售額的百分比（不包括特殊項目）為 28% 至 29%，這與 COVID 之前的水平相似。

Research and development expenses in the quarter grew 1% to $196 million or 16.4% of sales. This small increase was primarily the result of higher investments in TMTT and costs associated with discontinuing our SUTRAFIX program, partially offset by reduced performance-based compensation.

本季度研發費用增長 1% 至 1.96 億美元，佔銷售額的 16.4%。這一小幅增長主要是由於對 TMTT 的更高投資以及與終止我們的 SUTRAFIX 計劃相關的成本，部分被基於績效的薪酬減少所抵消。

For the full year 2021, we continue to expect R&D as a percentage of sales to be in the 17% to 18% range, similar to pre-COVID levels, as we invest in developing new technologies and generating evidence to expand indications for TAVR and TMTT including enrolling 7 clinical trials.

對於 2021 年全年，我們繼續預計研發佔銷售額的百分比將在 17% 至 18% 的範圍內，與 COVID 之前的水平相似，因為我們投資於開發新技術和收集證據以擴大 TAVR 和TMTT包括入組7項臨床試驗。

Turning to taxes. Our reported tax rate this quarter was 13.1% or 13.9%, excluding the impact of special items. This rate included a 350 basis point benefit from the accounting for stock-based compensation. Our full year 2020 tax rate, excluding special items, was 12.5%. We continue to expect our full year rate in 2021, excluding special items, to be between 11% and 15%, including an estimated benefit of 5 percentage points from stock-based compensation accounting.

轉向稅收。我們本季度報告的稅率為 13.1% 或 13.9%，不包括特殊項目的影響。該比率包括從股票薪酬會計中獲得的 350 個基點收益。我們 2020 年全年的稅率（不包括特殊項目）為 12.5%。我們繼續預計 2021 年的全年增長率（不包括特殊項目）將在 11% 至 15% 之間，其中包括基於股票的薪酬會計估計帶來的 5 個百分點的收益。

Foreign exchange rates increased fourth quarter reported sales growth by 150 basis points or $18 million compared to the prior year. At current rates, we now expect an approximate $100 million positive impact or about 2% to full year 2021 sales compared to 2020. FX rates negatively impacted our fourth quarter gross profit margin by 150 basis points compared to the prior year.

外匯匯率上漲 第四季度報告的銷售額與去年同期相比增長了 150 個基點或 1800 萬美元。按照目前的速度，我們現在預計與 2020 年相比，2021 年全年銷售額將產生約 1 億美元的積極影響或約 2%。與去年同期相比，匯率對我們第四季度的毛利率產生了 150 個基點的負面影響。

Free cash flow for the fourth quarter was $287 million, defined as cash flow from operating activities of $400 million less capital spending of $113 million.

第四季度的自由現金流為 2.87 億美元，定義為經營活動產生的現金流 4 億美元減去 1.13 億美元的資本支出。

Now turning to the balance sheet. We have a strong balance sheet with approximately $2.2 billion in cash and investments as of the end of the year. In addition, we have an undrawn line of credit of up to $1 billion. We have public bonds outstanding of about $600 million that don't mature until 2028. Average shares outstanding during the fourth quarter were 632 million, relatively consistent with the prior quarter. We now expect average diluted shares outstanding for 2021 to be between 630 million and 635 million.

現在轉向資產負債表。截至年底，我們的資產負債表穩健，現金和投資約為 22 億美元。此外，我們還有高達 10 億美元的未提取信貸額度。我們有約 6 億美元的未償還公共債券，這些債券要到 2028 年才會到期。第四季度平均流通股為 6.32 億股，與上一季度基本持平。我們現在預計 2021 年平均攤薄流通股將在 6.3 億至 6.35 億股之間。

So before turning the call back over to Mike, I'll finish with financial guidance for 2021. We are maintaining all of our previous sales guidance ranges for 2021. For total Edwards, we expect sales of $4.9 billion to $5.3 billion. For TAVR, we expect sales of $3.2 billion to $3.6 billion. For TMTT, we expect sales of approximately $80 million. We expect Surgical Structural Heart sales of $800 million to $900 million and Critical Care sales of $725 million to $800 million.

因此，在將電話轉回給邁克之前，我將完成 2021 年的財務指導。我們將維持之前 2021 年的所有銷售指導範圍。對於 Edwards 的總銷售額，我們預計銷售額為 49 億美元至 53 億美元。對於 TAVR，我們預計銷售額為 32 億美元至 36 億美元。對於 TMTT，我們預計銷售額約為 8000 萬美元。我們預計 Surgical Structural Heart 銷售額為 8 億至 9 億美元，重症監護銷售額為 7.25 億美元至 8 億美元。

For the full year 2021, we continue to expect adjusted earnings per share of $2 to $2.20. For the first quarter of 2021, we project total sales to be between $1.1 billion and $1.2 billion and adjusted earnings per share of $0.43 to $0.50.

對於 2021 年全年，我們繼續預計調整後的每股收益為 2 美元至 2.20 美元。對於 2021 年第一季度，我們預計總銷售額在 11 億美元至 12 億美元之間，調整後的每股收益為 0.43 美元至 0.50 美元。

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

因此，我會把它傳回給邁克。

Thanks, Scott.

謝謝，斯科特。

While a year like 2020 could threaten to cause persistent disruptions, our strategy of patient-focused innovations remains unwavering. As we look to 2021 and beyond, I'm as excited as ever about the work happening at Edwards and more importantly, what we envision for the future of patient care. I continue to believe we are poised for success and that our innovation and cultural imperative to put patients first will drive strong organic sales growth and create long-term value. .

雖然像 2020 年這樣的一年可能會造成持續的破壞，但我們以患者為中心的創新戰略仍然堅定不移。展望 2021 年及以後，我對 Edwards 所做的工作一如既往地感到興奮，更重要的是，我們對未來患者護理的設想。我仍然相信我們已為成功做好準備，我們將患者放在首位的創新和文化要求將推動強勁的有機銷售增長並創造長期價值。 .

And with that, I'll turn it back over to Mark.

有了這個，我會把它轉回給馬克。

Thanks a lot, Mike. With that, we're ready to take questions. (Operator Instructions) Diego?

非常感謝，邁克。有了這個，我們準備好接受提問了。（操作員說明）迭戈？

(Operator Instructions) Our first question comes from Bob Hopkins with Bank of America.

（操作員說明）我們的第一個問題來自美國銀行的鮑勃霍普金斯。

Mike, I was wondering, since we just met in December, if you can comment on maybe just 2 quick things. First question would be just how different is the environment out there right now -- the selling environment out there right now versus what you were seeing at the time of the Analyst Day? Kind of on the margins, are things getting a little worse, are they getting a little better? Just would love some thoughts on that topic. And then I have one quick follow-up.

邁克，我想知道，自從我們在 12 月才見過面，你是否可以就兩件簡單的事情發表評論。第一個問題是現在的環境有何不同——現在的銷售環境與您在分析師日時看到的情況有何不同？有點邊緣，事情變得更糟了，他們變得更好了嗎？只是會喜歡關於那個話題的一些想法。然後我有一個快速跟進。

Yes. I would say in general, it's been a little worse. It was already trending negative, and we anticipated it was going to be a tough winter, and it certainly has turned out to be that way, but probably trending a little worse since that time.

是的。我會說，總的來說，情況更糟了。它已經呈負趨勢，我們預計這將是一個艱難的冬天，結果確實如此，但自那時以來趨勢可能更糟。

Okay. And then the other thing I'd love to get your quick comments on is just thinking a little bit long term on the tricuspid opportunity. And the reason I ask is that obviously Abbott has reported some numbers, too, and their tricuspid business is already annualizing at over $50 million, if you just take the results this quarter and multiply times 4. So it looks like some pretty robust interest in tricuspid repair right off the bat.

好的。然後我想得到你的快速評論的另一件事是對三尖瓣機會的長期思考。我問的原因是，顯然雅培也報告了一些數字，他們的三尖瓣業務已經年化超過 5000 萬美元，如果你只是把這個季度的結果乘以 4。所以看起來對馬上修復三尖瓣。

So would love your thoughts on that market and how quickly you think that could develop and what hurdles might be.

所以會喜歡你對那個市場的想法，你認為它會發展多快，可能會有什麼障礙。

Yes. Thanks, Bob. It's interesting. So the tricuspid market size in terms of number of patients, it's very large. It's certainly as big as the mitral opportunity. And we've talked about the fact that, that patient group is greatly underserved. So in terms of people actually getting procedures, you're talking about 1%, 2%, 3%, very low numbers.

是的。謝謝，鮑勃。這真有趣。因此，就患者數量而言，三尖瓣市場規模非常大。它肯定和二尖瓣機會一樣大。我們已經談到了這樣一個事實，即該患者群體的服務嚴重不足。因此，就實際接受程序的人而言，你說的是 1%、2%、3%，非常低的數字。

So if we could actually develop a great solution for them, it's going to be an important deal. They don't have great answers, and so the burden is going to be on us to develop great solutions and to create evidence that we are actually doing that. We have a high level of confidence that we can do it. Of course, mitral is going to be bigger here in the near term. It's got an earlier start, but we think there's a lot of potential in this.

因此，如果我們真的能為他們開發一個很好的解決方案，那將是一筆重要的交易。他們沒有很好的答案，因此我們有責任制定很好的解決方案並創造證據證明我們確實在這樣做。我們有很高的信心，我們可以做到。當然，二尖瓣在短期內會變得更大。它起步較早，但我們認為這方面有很大的潛力。

The patients themselves are very diverse. And that's why we think when it's all done for tricuspid patients, it's going to require a portfolio.

患者本身非常多樣化。這就是為什麼我們認為當為三尖瓣患者完成所有工作後，將需要一個組合。

Our next question comes from David Lewis with Morgan Stanley.

我們的下一個問題來自摩根士丹利的大衛劉易斯。

Mike or Scott, just want to follow up here on guidance for a second. So obviously, resurge in trends have probably trended more negatively than when you sort of gave early guidance in December. So while things are trending more negatively, you're still sort of holding the outlook for '21.

邁克或斯科特，只想在這裡跟進一下指導。很明顯，趨勢的複蘇可能比你在 12 月給出早期指導時更消極。因此，儘管事情的趨勢更加消極，但您仍然對 21 年持樂觀態度。

So I guess what's providing that kind of comfort that even though your near-term things are heading more difficultly, you still feel very good about the '21 numbers? Is that just what you're seeing here in the first quarter? Is that new account recovery? Is that just the pace of the recovery you saw last time, but same confidence, stacks have changed? What's providing that confidence? And a quick follow-up.

所以我想是什麼提供了那種安慰，即使你的近期事情變得更加困難，你仍然對 21 年的數字感覺很好？這就是你在第一季度在這裡看到的嗎？那是新帳戶恢復嗎？這是否只是您上次看到的複蘇步伐，但同樣的信心，籌碼已經改變？是什麼提供了這種信心？並進行快速跟進。

Yes. Thanks, David. So we always anticipated it was going to be a slow start to the year. It was going to take a while for vaccines to have any impact. It's probably turned out to be a little worse than we thought, but it really hasn't changed our outlook. We really believe that coming out of the winter, we're going to start gaining ground on this, that you're going to have vaccines widely distributed by the middle of the year and that we're going to be returning to normalization. So when we put that together, it gives us considerable confidence.

是的。謝謝，大衛。所以我們一直預計今年的開局會很緩慢。疫苗需要一段時間才能產生任何影響。結果可能比我們想像的要糟糕一些，但它確實沒有改變我們的看法。我們真的相信，過了冬天，我們將開始在這方面取得進展，你將在今年年中廣泛分發疫苗，我們將恢復正常化。所以當我們把它們放在一起時，它給了我們相當大的信心。

Yes, is it maybe slightly weaker than it was when we gave the guidance at the investor conference. Yes, maybe, but we're still very much in the range.

是的，它可能比我們在投資者會議上給出指導時略微弱一些。是的，也許吧，但我們仍然在這個範圍內。

Okay. And then just, Mike, just strategically, this comment of clinical trial enrollment is coming up a lot from you, other companies now. And I wonder 2 things. The first is, have you rethought -- you have a significant number of clinical trials sort of ongoing, have you thought at all about change in the clinical trial strategy, slowing some down, emphasizing others as sort of question one.

好的。然後，邁克，從戰略上講，這種臨床試驗註冊的評論現在從你和其他公司那裡得到了很多。我想知道兩件事。首先是，你是否重新考慮過——你有大量的臨床試驗正在進行中，你是否考慮過改變臨床試驗策略，放慢一些，強調其他作為第一個問題。

And then related is just figuring it benefits the incumbent for all the companies that are trying to get into this marketplace. They've lost basically 18 months and sort of, competitively, does that start becoming a bigger advantage to those that are already in the market, specifically in structural heart and TAVR with the trial burden is very high?

然後相關的只是認為它有利於所有試圖進入這個市場的公司的現任者。他們基本上已經失去了 18 個月，在競爭中，這是否開始成為那些已經進入市場的人的更大優勢，特別是在結構性心臟和 TAVR 方面，試驗負擔非常高？

Yes. Thanks, David. You make a good point. The trial burden is high, and so it is more difficult right now. I can tell you that our team and our researchers are very committed. They're ready to get back at it. And so although there were delays, I don't know if it's fair to characterize it as an 18-month delay, David. I think that's probably overstating it to some extent. I think we talked when we said what happened in 2020, for example, in some of the TMTT trials, it certainly cost us a couple of quarters, and now we're seeing it a little slow again. But our team really feels, through conversations with researchers, that it's going to come back.

是的。謝謝，大衛。你說的對。審判負擔高，所以現在比較困難。我可以告訴你，我們的團隊和研究人員非常投入。他們準備好報復了。因此，雖然有延遲，但我不知道將其描述為 18 個月的延遲是否公平，大衛。我認為這可能在某種程度上誇大了它。我想當我們說 2020 年發生的事情時我們談過，例如，在一些 TMTT 試驗中，它肯定花費了我們幾個季度的時間，現在我們又看到它有點慢了。但我們的團隊通過與研究人員的交談，確實感覺到它會捲土重來。

When you're trying to develop real new opportunities like TMTT or expand indications in TAVR like early TAVR in moderate AS, those are heavy lifts that take long-term commitment, and we're getting really nice participation in cooperation with FDA. So it's going to get done. It just is a bit of a headwind right now.

當你試圖開發像 TMTT 這樣的真正的新機會或擴大 TAVR 的適應症時，比如在中度 AS 中進行早期 TAVR，這些都是需要長期承諾的繁重工作，我們在與 FDA 的合作中得到了很好的參與。所以它會完成的。現在只是有點逆風。

Our next question comes from Raj Denhoy with Jefferies.

我們的下一個問題來自 Jefferies 的 Raj Denhoy。

I wanted to ask a little bit on the near term as well. You mentioned that some of the larger centers were maybe seeing slower referrals. Is there anything you can comment really on how that pipeline looks and how quickly can refill if things do start to open up? In a sense, will there be a kind of continued lag effect on your recovery relative to what happens in the broader market because of that referral network?

我也想問一些關於近期的問題。您提到一些較大的中心可能會看到轉介速度較慢。關於管道的外觀以及如果事情確實開始開放，可以多快重新填充，您有什麼可以真正評論的嗎？從某種意義上說，相對於由於該推薦網絡而在更廣泛的市場上發生的情況，您的恢復是否會有一種持續的滯後效應？

Yes. Thanks, Raj. So what we were referring to is just reflecting back on the fourth quarter, we had this observation that the larger centers saw less growth than the smaller centers. The exactly why that happened, we can -- we only kind of speculate, Raj.

是的。謝謝，拉吉。所以我們所指的只是回顧第四季度，我們觀察到較大的中心的增長低於較小的中心。發生這種情況的確切原因，我們可以——我們只能推測，Raj。

So we obviously have conversations with them, and we have anecdotal information that suggests, hey, those larger centers maybe used to pull from much broader geography, and maybe there's less referrals during this time of COVID than you would expect in a normal environment.

因此，我們顯然與他們進行了對話，並且我們有軼事信息表明，嘿，那些較大的中心可能用於從更廣泛的地理區域中拉出，並且在 COVID 期間可能比您在正常環境中預期的要少。

So having said that, when these centers slow down, yes, they also slow down qualifying patients. So it takes a while for that pipeline to refill. So that is -- that's legitimate. But then again, when we gave our estimates, we've taken that into account. So when we say, "Hey, we think TAVR is going to grow 15% to 20% in 2021," we've taken into account that, yes, there's this lag at the beginning of the year. So we're still coming on sites to engage with patients, and they're very motivated to do that. But to give you -- you know where we're headed.

所以話雖如此，當這些中心放慢速度時，是的，它們也會放慢符合條件的患者的速度。因此，該管道需要一段時間才能重新填充。那就是——那是合法的。但話又說回來，當我們給出我們的估計時，我們已經考慮到了這一點。因此，當我們說，“嘿，我們認為 TAVR 將在 2021 年增長 15% 至 20%”時，我們已經考慮到，是的，年初存在這種滯後。所以我們仍然在網站上與患者互動，他們非常願意這樣做。但是給你——你知道我們要去哪裡。

Understood. Yes. And then just one quick follow-up on that. So LOTUS, obviously off the market globally. Have you seen much impact in the marketplace? Have you been able to capture some of that share? Any thoughts early on in how that's faring?

明白了。是的。然後只是一個快速跟進。所以 LOTUS，顯然在全球範圍內退出市場。你在市場上看到了很大的影響嗎？您是否能夠捕獲其中的一些份額？早期有什麼想法嗎？

Yes. Thanks, Raj. They didn't have a really large share position. And so I'm sure we were the beneficiary to a small extent. If I reflect all the way back to our investor conference in 2019, we estimated that we would probably have some small share loss during 2020, and we don't -- it's kind of tough for us to find that at this point. We're not sure that, that happened. That may have been part of a contributor.

是的。謝謝，拉吉。他們並沒有真正大的股份地位。所以我確信我們在一定程度上是受益者。如果我一直回想我們在 2019 年的投資者會議，我們估計我們在 2020 年可能會有一些小的份額損失，而我們沒有——我們現在很難發現這一點。我們不確定，那件事發生了。那可能是貢獻者的一部分。

Our next question comes from Larry Biegelsen with Wells Fargo.

我們的下一個問題來自富國銀行的 Larry Biegelsen。

One on PASCAL for me, one on a different one separately. So Mike, you expect to launch PASCAL in the U.S. in late '22. Does that assume completing enrollment in 2021 of CLASP IID and presenting the data in early '22? And PASCAL Precision, Mike, what are the benefits of that and the timing? And I had one follow-up.

一個對我來說是 PASCAL，另一個是分開的。所以邁克，你希望在 22 世紀末在美國推出 PASCAL。這是否假設在 2021 年完成 CLASP IID 的註冊並在 22 年初提交數據？PASCAL Precision，邁克，這樣做的好處和時機是什麼？我有一個後續行動。

Yes. Thanks, Larry. So let me be a little bit more precise. So what we said is that we'll get approval by the end of '22 and the next year, and we'll probably be launching in '23. So I wouldn't want to necessarily model sales in 2022. Exactly what the run-up looks like before that, we're not -- we haven't really talked about. We haven't laid it up. Obviously, you're right, there's multiple steps: when do we complete enrollment, when do we complete the follow-up, when do the report show up. And I don't have clear estimates for you at this time of when that's going to happen.

是的。謝謝，拉里。所以讓我更精確一點。所以我們說的是，我們將在 22 年底和明年獲得批准，我們可能會在 23 年推出。所以我不想在 2022 年對銷售進行建模。在那之前的準備工作究竟是什麼樣子，我們不是——我們還沒有真正談論過。我們還沒有把它放下。顯然，你是對的，有多個步驟：我們什麼時候完成註冊，什麼時候完成跟進，什麼時候出報告。目前我還沒有明確的估計，你會知道什麼時候會發生。

As it relates to the PASCAL Precision, we're really proud of that system. It's designed to deliver significant advancements to our stabilizer and our catheter and our handle. It's -- the Precision 1 is now -- we haven't really laid out timing. I think that's going to sort of evolve over the course of 2021, but I can probably come back with more accurate timing at a later date.

由於它與 PASCAL Precision 相關，我們為該系統感到非常自豪。它旨在為我們的穩定器、導管和手柄帶來重大進步。它是——Precision 1 現在——我們還沒有真正確定時間。我認為這將在 2021 年期間有所發展，但我可能會在晚些時候以更準確的時間回來。

And Mike, a few years ago, you were developing a product for aortic insufficiency. What's the status? And what are your thoughts on that market opportunity? Is it just to too small, given all the bigger opportunities that you're pursuing now?

邁克，幾年前，你正在開發一種治療主動脈瓣關閉不全的產品。現狀如何？您對這個市場機會有何看法？考慮到您現在正在追求的所有更大的機會，它是否太小了？

Yes. We really don't have much there, Larry, to say that, that is a pipeline item that's imminent. That goes back quite a way.

是的。拉里，我們真的沒有太多可以說的，這是一個迫在眉睫的管道項目。這可以追溯到很久以前。

The one product that we have that sort of helps that group of patients is really in the surgical side. This KONECT product that also replaces the aortic route, that certainly helps those kind of patients. But to suggest that we have a transcatheter one around the corner would be overstating it.

我們擁有的一種產品可以真正幫助那組患者進行外科手術。這種 KONECT 產品也取代了主動脈通路，這肯定會幫助那些類型的患者。但是建議我們在拐角處有一個經導管的會誇大它。

Our next question comes from Robbie Marcus with JPMorgan.

我們的下一個問題來自摩根大通的 Robbie Marcus。

Great. So with a little slowdown here with COVID, what are you seeing in terms of trial enrollment? Is that also getting delayed? And is that assumed in the time lines that you gave us today?

偉大的。因此，隨著 COVID 的放緩，您在試用註冊方面看到了什麼？是不是也耽誤了？這是在您今天給我們的時間線中假設的嗎？

Yes. Thanks, Robbie. So yes, we are feeling it in trial enrollment. This is not an easy time when we're going through what we just saw here at the end of the quarter and the start of this quarter. It is a tough time.

是的。謝謝，羅比。所以是的，我們在試註冊中感受到了這一點。當我們正在經歷我們剛剛在本季度末和本季度初看到的情況時，這不是一個輕鬆的時期。這是一段艱難的時期。

It's kind of funny. I mean, the hospitals that -- it's not like all hospitals have been impacted, but the ones that have been impacted are really full up, right? They really struggle to be able to handle new patients, which includes clinical trials.

這有點好笑。我的意思是，並不是所有醫院都受到了影響，但受到影響的醫院真的滿員了，對吧？他們真的很難處理新患者，包括臨床試驗。

So -- but having said that, all the dates that we gave you anticipated what's going on. We would give you new dates if we didn't think that we could achieve those. So yes, it's at a tough time right now. Yes, it is. But do we think that there's going to be a recovery? There's a lot of interest amongst the clinical researchers to get back at it. And really, they're enthusiastic about it as we are, and so we think that we're going to get after it pretty hard when it opens back up again.

所以 - 但話說回來，我們給你的所有日期都預料到了會發生什麼。如果我們認為我們無法實現這些目標，我們會給您新的日期。所以是的，現在正處於艱難時期。是的。但是我們認為會有復蘇嗎？臨床研究人員對此很感興趣。真的，他們和我們一樣對此充滿熱情，所以我們認為當它再次開放時我們會非常努力地追求它。

Great. Still a lot of sick patients that need help.

偉大的。還有很多病人需要幫助。

Yes, there are.

是的，有。

Unfortunately.

很遺憾。

Maybe just a quick follow-up. You're still generating a very healthy amount of cash even in 2021 here. How should we think about the priorities for that use of cash? And are there any areas to the business that might see some M&A potential?

也許只是一個快速跟進。即使在 2021 年，您仍然可以在這裡產生非常可觀的現金。我們應該如何考慮現金使用的優先順序？該業務是否有任何領域可能會出現一些併購潛力？

Robbie, it's Scott. Thanks for the question. So our focus and our priorities for use of cash haven't really changed. The first one, of course, is making sure that we've got sufficient cash to invest in internal growth opportunities, and that includes building out our plant infrastructure. So we've got now multiple production facilities around the world. We've recently gotten a lot further along and are almost completed with Costa Rica. We've broken ground on a new facility in Ireland. And as the company continues to grow, we'll continue to in a disciplined fashion, invest capital to support that growth on the production side.

羅比，是斯科特。謝謝你的問題。因此，我們使用現金的重點和優先事項並沒有真正改變。第一個當然是確保我們有足夠的現金來投資內部增長機會，其中包括建設我們的工廠基礎設施。所以我們現在在世界各地擁有多個生產設施。我們最近在哥斯達黎加取得了很大進展，幾乎完成了。我們在愛爾蘭的新工廠破土動工。隨著公司的不斷發展，我們將繼續以一種有紀律的方式，投資資金以支持生產方面的增長。

As it relates to M&A, we're very active on the business development front, and we are continually looking for external growth opportunities. As you know, most of these are typically small. We usually buy pre-revenue companies or technologies or we'll make investments in companies or buy options to acquire companies based upon how they perform in development efforts. And so those activities will continue. We've got this -- we've got a good problem to have, which is we continue to generate net cash, and that's why we've got over $2 billion now on the balance sheet.

由於涉及併購，我們在業務發展方面非常活躍，我們一直在尋找外部增長機會。如您所知，其中大多數通常都很小。我們通常購買收入前的公司或技術，或者我們將根據公司在開發工作中的表現對公司進行投資或購買期權以收購公司。因此，這些活動將繼續進行。我們有這個 - 我們有一個很好的問題，那就是我們繼續產生淨現金，這就是為什麼我們的資產負債表上現在有超過 20 億美元。

And so we think carefully about how to do that, and we think carefully about how to manage the share count. And for the time being and for the foreseeable future, our preferred means of returning capital to shareholders will be through continued share repurchase. And we've got over $600 million of share repurchase authorization left.

所以我們仔細考慮如何做到這一點，我們仔細考慮如何管理股票數量。目前和可預見的未來，我們向股東返還資本的首選方式將是通過持續的股份回購。我們還有超過 6 億美元的股票回購授權。

Our next question comes from Josh Jennings with Cowen.

我們的下一個問題來自 Josh Jennings 和 Cowen。

Just 2, one, the $7 billion -- reiteration, the $7 billion TAVR market by 2024. The first is you've had that target for a couple little while now in front of the China approval. Does that include an internal assumption for -- within the market for China TAVR?

只有 2 個，一個，70 億美元——重申一下，到 2024 年 TAVR 市場將達到 70 億美元。首先是在中國批准之前，你已經有一段時間了這個目標。這是否包括在中國 TAVR 市場內的內部假設？

And then the second layer is just thinking about TAVR-in-TAVR and TAVR-in-SAVR, could those 2 indications represent 10% or more of that $7 billion opportunity in 2024?

然後第二層只是考慮 TAVR-in-TAVR 和 TAVR-in-SAVR，這兩個適應症能否代表 2024 年 70 億美元機會的 10% 或更多？

Yes. Thanks, Josh. Yes. So we feel pretty confident in that plus $7 billion TAVR market opportunity. It does include China. It also includes most of those indication expansions like you just mentioned, like TAVR-in-TAVR and TAVR-in-SAVR. What's not in there really is EARLY TAVR, so these asymptomatic patients. If we got that, it would be very late in the period, so probably hardly an impact. And we're not expecting moderate to read out and really impact that number as well. So maybe that is -- is that sufficient to answer your question?

是的。謝謝，喬希。是的。因此，我們對此非常有信心加上 70 億美元的 TAVR 市場機會。它確實包括中國。它還包括您剛才提到的大多數適應症擴展，例如 TAVR-in-TAVR 和 TAVR-in-SAVR。那裡真正沒有的是 EARLY TAVR，所以這些無症狀的患者。如果我們得到它，那將是很晚的時期，所以可能幾乎沒有影響。而且我們不希望溫和地讀出並真正影響這個數字。所以也許這足以回答您的問題嗎？

Yes. I appreciate it.

是的。我很感激。

Our next question comes from Suraj Kalia with Oppenheimer.

我們的下一個問題來自 Suraj Kalia 和 Oppenheimer。

Mike, a couple of quick questions. I just wanted to follow up on Raj's question on TAVR, and then I have a TMTT question. Forgive me if I heard it wrong, why would referrals in the largest centers in the U.S. be different than the smaller centers?

邁克，幾個簡單的問題。我只想跟進 Raj 關於 TAVR 的問題，然後我有一個 TMTT 問題。如果我聽錯了，請原諒我，為什麼美國最大中心的推薦與較小中心的推薦不同？

And if I could throw in my TMTT question, for PASCAL in Europe, Mike, for the centers that are early adopters, what is the -- if a patient comes in, what would be the key rationale for them choosing PASCAL versus, let's say, a G3 MitraClip?

如果我可以提出我的 TMTT 問題，對於歐洲的 PASCAL，邁克，對於早期採用者的中心，是什麼 - 如果患者進來，他們選擇 PASCAL 的關鍵理由是什麼，比方說, G3 MitraClip?

Sure. So going back to the large centers versus small centers. First of all, this was simply an observation on our part. If we looked at our largest centers versus our smaller centers, the smallest centers grew faster in the fourth quarter than the largest centers. So now why is that? Well, now we start speculating to some extent because we really don't have that clear a picture. It's just the fact of how that happened.

當然。所以回到大中心與小中心。首先，這只是我們的一個觀察。如果我們比較我們最大的中心與我們較小的中心，第四季度最小的中心比最大的中心增長得更快。那麼現在為什麼會這樣呢？好吧，現在我們開始在某種程度上進行推測，因為我們真的沒有那麼清晰的畫面。這只是發生的事實。

Part of what we have heard anecdotally is that the large centers will often prove -- a matter of fact, attract patients, let's say, from a multistate area, whereas a small center might only attract patients in their local area. And given COVID being what it is, are these elderly patients willing to travel long distances to a referral center? We wonder and we hear from others, they speculate that that's the reason. So again, you can take that for what it's worth, but that's probably the best answer that we have on that one.

我們聽到的部分軼事是，大型中心通常會證明——事實上，可以吸引來自多州地區的患者，而小型中心可能只會吸引當地的患者。鑑於 COVID 的現狀，這些老年患者是否願意長途跋涉前往轉診中心？我們想知道，我們從其他人那裡聽到，他們推測這就是原因。再說一次，你可以把它當作它的價值，但這可能是我們對該問題的最佳答案。

The -- in terms of the centers that are adopters, how does it compare? We feel really good about the outcomes. We've been doing a lot of work in Europe trying to help people have outstanding outcomes. And so clinicians have experience with PASCAL, and many of those experiences have -- many of those clinicians also have experience with the MitraClip system. We have both PASCAL and PASCAL ACE, so they have options in terms of what they might use. And I think it's a patient-specific decision that clinicians are making at this point of what they think might be best for their patients.

就作為採用者的中心而言，它如何比較？我們對結果感覺非常好。我們在歐洲做了很多工作，試圖幫助人們取得出色的成果。因此，臨床醫生有使用 PASCAL 的經驗，其中許多經驗都有——其中許多臨床醫生也有使用 MitraClip 系統的經驗。我們同時擁有 PASCAL 和 PASCAL ACE，因此他們可以根據自己的用途進行選擇。我認為這是臨床醫生在他們認為可能對患者最好的這一點上做出的針對患者的決定。

It's still early. Our data by comparison is still relatively light. Although we're proud that we have 3,000 patients that were treated last year, and most of those are with PASCAL. So we're starting to get some pretty good experience. But it's still -- there is some time before this plays out.

現在還早。相比之下，我們的數據還是比較清淡的。儘管我們為去年有 3,000 名患者接受治療而感到自豪，其中大部分患者都使用 PASCAL。所以我們開始獲得一些非常好的經驗。但它仍然——還有一段時間才能結束。

Our next question comes from Matt Miksic with Credit Suisse.

我們的下一個問題來自瑞士信貸的 Matt Miksic。

So I did want to have a follow-up on MitraClip. It's just -- and on the mitral repair, I should say, and PASCAL in Europe. Wondering if you're seeing any difference in the sort of variability or referral of, say, mitral repair in the small -- relatively smaller footprint that you have there versus TAVR. Just one of your competitors reported, and those numbers were down a little harder maybe then sort TAVR volumes are down. I'm just trying to sort through what that could mean, if anything. And any color you have would be appreciated. I have one follow-up.

所以我確實想對 MitraClip 進行跟進。這只是——我應該說，在二尖瓣修復術和歐洲的 PASCAL 修復術上。想知道您是否看到在較小的二尖瓣修復中的可變性或轉診類型有任何差異 - 與 TAVR 相比，您在那裡的佔地面積相對較小。只有您的一個競爭對手報告說，這些數字下降得更厲害一些，然後排序 TAVR 量下降了。我只是想弄清楚這可能意味著什麼，如果有的話。您擁有的任何顏色都將不勝感激。我有一個跟進。

Yes. Thanks, Matt. I think I understand your question. Are you saying, "Hey, it looks like the mitral numbers are down more than the aortic numbers?" And is that the question?

是的。謝謝，馬特。我想我明白你的問題。你是說，“嘿，看起來二尖瓣數比主動脈數下降得更多？”這是問題嗎？

That is correct.

那是對的。

Okay. Yes. In fact, that is our observation as well. It appears that, that is indeed the case. Now I'm going to speculate as to why.

好的。是的。事實上，這也是我們的觀察。看來，的確如此。現在我要推測原因。

TAVR has been out there for quite a while. We have really compelling evidence. We have very mature systems, very reproducible results, well-trained infrastructure. By comparison on the mitral side, it's still relatively young. The indications aren't nearly as clear. So it's a less mature market and not a surprise probably that, that's taking place. But I think your observations are correct ones.

TAVR 已經存在了很長一段時間。我們有真正令人信服的證據。我們擁有非常成熟的系統、非常可重複的結果和訓練有素的基礎設施。相比之下，二尖瓣側還比較年輕。這些跡象幾乎沒有那麼清楚。因此，這是一個不太成熟的市場，並且正在發生這種情況可能不足為奇。但我認為你的觀察是正確的。

Great. And then just a follow-up, and I apologize if it's been asked, but just the sort of maybe confidence in the sort of, I call it, acceleration maybe off of a slightly lower, more sluggish Q1 and then getting to your original range for full year, what gives you that sort of confidence that you'll be able to kind of bounce back in Q2 and still wind up in roughly the same place?

偉大的。然後只是一個跟進，如果有人問我，我深表歉意，但我稱之為那種可能的信心，加速可能會從略低、更緩慢的 Q1 開始，然後達到你原來的範圍對於全年，是什麼讓您有信心在第二季度反彈並仍處於大致相同的位置？

Yes. There was a version of that, that, that was Matt, and that's fine. We really do have confidence that it's going to come back. We think it's going to be ramped during the course of the year.

是的。有一個版本，那就是馬特，這很好。我們確實有信心它會回來。我們認為它會在這一年中增加。

Q1, just based on what we're seeing so far, is going to be a tough quarter, and so we acknowledge that. But we always thought it would be tough. It might be a little tougher than we thought, but we really believe that there's a lot of pent-up demand of patients and that they're very much going to seek treatment. And once the fear of COVID and once hospitals get themselves squared away, we think they really will -- they'll be in much better shape by the time we get into the second half of the year that we're going to realize those kind of growth rates.

第一季度，就我們目前所看到的情況而言，將是一個艱難的季度，所以我們承認這一點。但我們一直認為這會很艱難。這可能比我們想像的要難一些，但我們真的相信患者有很多被壓抑的需求，他們非常願意尋求治療。一旦對 COVID 的恐懼和醫院擺正姿勢，我們認為他們真的會——到下半年我們將意識到這些時，他們的狀況會好得多的增長率。

Our next question comes from Danielle Antalffy with SVB Leerink.

我們的下一個問題來自 SVB Leerink 的 Danielle Antalffy。

Mike, if I could just follow up on the referral question. And I'm not sure what level of visibility you guys do have into the referral channel. But just curious what you saw in the sort of June, July, August time frame as far as refilling the funnel and how quickly that happens and whether that could serve as a proxy to what we could see whenever we get past this most recent COVID resurgence.

邁克，如果我可以跟進推薦問題。我不確定你們對推薦渠道的了解程度如何。但只是好奇你在 6 月、7 月、8 月的時間框架內看到了什麼，就重新填充漏斗而言，這種情況發生的速度有多快，以及這是否可以作為我們在度過最近的 COVID 復甦後所能看到的情況的代理.

And I don't know if the right way to think about it is diagnostic facilities were operating at x percent of normal levels or what, but any color you could give there would be great.

而且我不知道正確的思考方式是否是診斷設施運行在正常水平的 x% 或什麼，但你可以給那裡任何顏色都會很棒。

Yes, your observation is a good one. I think we all remember the trauma that happened when the sort of the bottom fell out in the middle of March last year, and -- but we also remember that things recovered pretty quickly, right? There was a pretty sharp V that we felt.

是的，你的觀察很好。我想我們都記得去年 3 月中旬那種底部跌落時發生的創傷，而且 - 但我們也記得事情恢復得很快，對吧？我們感覺到了一個非常尖銳的 V 形。

And so this question about how fast does the pipeline fill up and how fast the patients come back, if that's any indication, it didn't take -- though it wasn't quarters. It was a matter of months, when things really started to bounce and pack. So yes, you're right. You could use that as some kind of a proxy to try and estimate what might happen now.

所以這個關於管道填滿的速度和病人回來的速度的問題，如果有任何跡象的話，它不需要——儘管不是四分之一。幾個月後，事情才真正開始反彈和打包。所以是的，你是對的。您可以將其用作某種代理來嘗試估計現在可能發生的情況。

Next question comes from Vijay Kumar with Evercore ISI.

下一個問題來自 Evercore ISI 的 Vijay Kumar。

A couple of quick, I guess, guidance questions. Gross margins, I think I heard you, Scott, mention 150 basis points of headwind in Q4. Given your comments on FX, any changes on how FX impact gross margins for fiscal '21 or Q1 perhaps?

我想有幾個快速的指導問題。毛利率，我想我聽到你，斯科特，在第四季度提到了 150 個基點的逆風。考慮到您對外彙的評論，外匯對 21 財年或第一季度毛利率的影響有何變化？

Sure. So in '21, we think FX probably hits us another 50 basis points negative on the gross margin line, and so we're coming off of -- in the fourth quarter, we finished at 75.3%, but we're also expecting better mix as TAVR continues to grow.

當然。因此，在 21 年，我們認為外匯可能使我們的毛利率再下降 50 個基點，因此我們即將結束——在第四季度，我們完成了 75.3%，但我們也期待更好隨著 TAVR 的持續增長而混合。

We've also got some operational efficiencies that they're going to continue to benefit on the gross margin line. And so we think we'll be able to largely offset that additional 50 basis points of FX pressure on gross margin and end up in that 76% to 77% range that we guided to.

我們還獲得了一些運營效率，他們將繼續在毛利率線上受益。因此，我們認為我們將能夠在很大程度上抵消額外 50 個基點的外匯壓力對毛利率的影響，並最終達到我們指導的 76% 至 77% 的範圍。

That's helpful. And then perhaps, Mike, you can chime in on this, but I'm curious, the share count assumption here for Q1 presumes no buybacks. I'm just curious, given the cash position, what would cause, I guess, for you guys to be a little bit more aggressive on the buybacks?

這很有幫助。然後也許，邁克，你可以插話，但我很好奇，這裡的第一季度股票數量假設假設沒有回購。我只是很好奇，考慮到現金狀況，我猜是什麼導致你們在回購方面更加激進？

Yes. I'll start, and I'll encourage Scott to jump in because he's very much the leader of this and a good partner.

是的。我會開始，我會鼓勵斯科特加入，因為他是這方面的領導者，也是一個很好的合作夥伴。

We have a long history of opportunistically buying shares when we think that there's a disconnect, but what we do routinely is to try and offset the dilution that's associated with our equity programs. So we're going to expect to do that. And I think that would be something that's typical. In terms of doing something opportunistic, we basically just look for disconnects.

當我們認為存在脫節時，我們有機會主義購買股票的悠久歷史，但我們通常所做的是試圖抵消與我們的股票計劃相關的稀釋。所以我們期望這樣做。我認為這很典型。在做一些機會主義的事情方面，我們基本上只是尋找脫節。

Yes. So we don't match exactly period-by-period the offsetting of dilution from equity awards, but we do, over time, try to not only offset that dilution but also buy down the total net shares outstanding. You've seen us do that consistently over time.

是的。因此，我們並沒有逐個時期地完全匹配股權獎勵稀釋的抵消，但隨著時間的推移，我們確實試圖不僅抵消這種稀釋，而且還買下已發行的淨股份總數。隨著時間的推移，您已經看到我們始終如一地這樣做。

So last year, we bought back about $625 million for the stock, which was in excess of the dilution from employee option exercises and delivery of restricted stock and the like. And so you should expect that we're going to continue to be opportunistic, as Mike said, and be active repurchasers over time.

所以去年，我們回購了大約 6.25 億美元的股票，這超過了員工期權行使和限制性股票交付等帶來的稀釋。因此，正如邁克所說，您應該期望我們將繼續投機取巧，並隨著時間的推移成為積極的回購者。

Yes. I want to say those average shares are around $68 a share. We consider that an opportunity.

是的。我想說這些平均股價約為每股 68 美元。我們認為這是一個機會。

Our next question comes from Matt Taylor with UBS.

我們的下一個問題來自瑞銀的馬特泰勒。

So I had 2 related questions. So we talked a lot about your clinical pipeline and new product flow. I was just hoping you could give us a couple key guideposts. What are you looking for this year in terms of data at PCR or other places, approvals that we should be watching out for?

所以我有 2 個相關問題。所以我們談了很多關於你的臨床管道和新產品流程的問題。我只是希望你能給我們一些關鍵的指南。你今年在 PCR 或其他地方尋找什麼數據，我們應該注意的批准？

And then as we're talking about the clinical trial delays in terms of enrollment, has it gotten to a point where you feel like you need to adjust any of your time lines? Or is it just a little bit slower and you're not there yet?

然後當我們談論臨床試驗在註冊方面的延遲時，是否已經到了您覺得需要調整任何時間表的地步？或者它只是慢了一點而你還沒有到那裡？

Yes. So I'll start with the second question. We really are not changing our time lines. If we were changing our time lines, we would certainly tell you. And we believe that we're going to hit those, and those are our best estimates. We try and do that as accurately as we can.

是的。那麼我將從第二個問題開始。我們真的沒有改變我們的時間表。如果我們要更改時間線，我們肯定會告訴您。我們相信我們會達到這些目標，這是我們最好的估計。我們嘗試盡可能準確地做到這一點。

In terms of what you're going to expect to see this year out of meetings like Euro PCR, I think what you're going to see for the most part is follow-up on the many trials, everything from EFS to CE Mark trials and more. So there'll be more patients. There'll be longer time frames where data will be shared. And so you'll see that we've got quite an extensive portfolio in TMTT. So I think you're going to see a number of reports over the course of the year.

就今年您期望在 Euro PCR 等會議中看到的內容而言，我認為您將看到的大部分內容是許多試驗的後續行動，從 EFS 到 CE 標誌試驗的一切和更多。所以會有更多的病人。共享數據的時間範圍會更長。因此，您會看到我們在 TMTT 中擁有相當廣泛的產品組合。所以我認為你會在這一年中看到許多報告。

And our last question comes from -- I'm sorry, our next question comes from Pito Chickering with Deutsche Bank.

我們的最後一個問題來自——對不起，我們的下一個問題來自德意志銀行的 Pito Chickering。

Two quick ones here. For the U.S. market, like your largest competitor has been pretty aggressive trying to take back market share in the back half of 2020. I'm just curious if you can give us any color on where the market share ended up during sort of the fourth quarter, and how we should think about market share changing one way or the other in 2021?

這裡有兩個快速的。對於美國市場，您最大的競爭對手一直在積極嘗試在 2020 年下半年奪回市場份額。我只是想知道您是否可以告訴我們第四季度市場份額的最終結果，以及我們應該如何考慮 2021 年市場份額以某種方式發生變化？

Yes. So yes, I think what we try to do is to -- I provided a statement in our prepared remarks that said that we felt like the market grew pretty much at the same pace that we did. So we didn't really see appreciable share change in the quarter.

是的。所以是的，我認為我們試圖做的是——我在我們準備好的發言中發表了一份聲明，說我們覺得市場的增長速度與我們的增長速度幾乎相同。所以我們並沒有真正看到本季度明顯的份額變化。

So again, having said that, it's pretty hard to determine what exact share positions are, and it's even more difficult during a pandemic. So we're not suggesting that it's exact, but in our estimates, it was pretty flat.

因此，話雖如此，還是很難確定確切的股票頭寸，而且在大流行期間更難。所以我們並不是說它是準確的，但在我們的估計中，它非常平坦。

Great. Then a quick follow-up for guidance. The U.S. markets and Europe is obviously weaker than you expected in December. We talked about strength in Japan, Australia and South Korea. Can you walk us through if those markets have accelerated versus the year -- your guidance at the Analyst Day and getting more color on the market?

偉大的。然後快速跟進指導。美國市場和歐洲在 12 月份明顯弱於您的預期。我們談到了日本、澳大利亞和韓國的實力。如果這些市場與一年相比有所加速，你能告訴我們嗎——你在分析師日的指導以及市場上的更多色彩？

So we're not suggesting that those 3 countries, for example, were better since the Analyst Day. What we're saying is those are examples of countries where the penetration is low and the growth rate is high. So those were really healthy growth rates, significantly above the rest of the portfolio that's pulling it up.

因此，我們並不是說這 3 個國家/地區自分析師日以來表現更好。我們所說的是那些滲透率低但增長率高的國家的例子。所以這些都是真正健康的增長率，大大高於其他拉動它的投資組合。

Now some of those are pretty small base by comparison. Like Korea and Australia would be pretty small compared to what's going on in Europe, et cetera. But nonetheless, as those treatment rates increase in those countries, it certainly helps the growth rate.

相比之下，現在其中一些基數很小。與歐洲等地正在發生的事情相比，韓國和澳大利亞的規模將非常小。但是儘管如此，隨著這些國家治療率的提高，這肯定有助於增長率。

And we have time for last question and that comes from Joanne Wuensch with Citibank.

我們有時間回答最後一個問題，這個問題來自花旗銀行的 Joanne Wuensch。

I'll make it quick. Doubling TMTT revenues in 2021 is impressive. Do you think you've hit sort of a tipping point? Can we think of this as an accelerant over the next couple of years? Or how do you think, broadly speaking -- and I recognize COVID makes it more difficult -- the TMT market in Europe?

我會盡快完成的。TMTT 收入在 2021 年翻一番令人印象深刻。你認為你已經達到了臨界點嗎？我們可以將其視為未來幾年的促進劑嗎？或者，從廣義上講，您如何看待歐洲的 TMT 市場——我承認 COVID 使它變得更加困難？

Yes. I think maybe it's just fair to say, Joanne, is this is a really big market opportunity. Remember, when we talk about it, we talk about it in billions. And when you look at where our sales are right now, they're really low. So our opportunity to grow at a pretty significant pace, I don't think it should be that surprising.

是的。我想也許公平地說，喬安妮，這是一個非常大的市場機會。請記住，當我們談論它時，我們談論的是數十億。當你看看我們現在的銷售額時，它們真的很低。因此，我們有機會以非常顯著的速度增長，我認為這並不令人驚訝。

The doubling is nice, and we're pleased to do that, but we've got a long way to go. We really think it's important. It's a big opportunity for us. The big drivers are going to be our evidence. When we really put strong clinical evidence up there that's compelling in significant clinical trials, those are the kind of things that are really going to drive even more significant inflection points, if you will.

翻倍很好，我們很高興這樣做，但我們還有很長的路要走。我們真的認為這很重要。這對我們來說是一個很大的機會。主要驅動力將成為我們的證據。當我們真正提出強有力的臨床證據時，這些證據在重要的臨床試驗中具有說服力，如果你願意的話，這些確實會推動更重要的拐點。

Of course, we've got a great team and a nice reputation and nice really differentiated products, but the data is going to be the bigger issue. And again, it's got much more potential than this in the long run.

當然，我們擁有一支優秀的團隊、良好的聲譽和真正與眾不同的產品，但數據將成為更大的問題。而且，從長遠來看，它的潛力比這大得多。

And that's all the questions we have. I'll turn it back to Mr. Mussallem for closing remarks.

這就是我們所有的問題。我會把它轉回 Mussallem 先生作結束語。

Okay. Well, thanks for all the continued interest in Edwards. And even though COVID is challenging right now, we do see better days ahead, and we're very optimistic about the future of Edwards Lifesciences.

好的。好吧，感謝大家對愛德華茲的持續關注。儘管 COVID 現在充滿挑戰，但我們確實看到未來會更好，我們對 Edwards Lifesciences 的未來非常樂觀。

So Mark, Scott and I welcome any additional questions by telephone. And with that, back to you, Mark.

因此，馬克、斯科特和我歡迎通過電話提出任何其他問題。然後，馬克，回到你身邊。

I don't think Mark's mic is open now, sir.

先生，我認為 Mark 的麥克風現在沒有打開。

Thank you. And this concludes today's conference. And you can access the replay by dialing (877) 660-6853. Please use conference ID 13710472.

謝謝。今天的會議到此結束。您可以撥打 (877) 660-6853 觀看重播。請使用會議 ID 13710472。

Have a good day. Thank you.

祝你有美好的一天。謝謝。