ABIOMED Inc (ABMD) 2021 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Fourth Quarter 2021 Abiomed Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

女士們、先生們，感謝大家的支持，歡迎參加 2021 年第四季 Abiomed 收益電話會議。 （操作員指示）請注意，今天的會議正在錄製中。 （操作員說明）

I would now like to hand the conference over to Todd Trapp. Please go ahead.

我現在想把會議交給托德·特拉普。請繼續。

Thanks, Sara. Good morning, and welcome to Abiomed's Fourth Quarter '21 Earnings Conference Call. This is Todd Trapp, Vice President and Chief Financial Officer. And I'm here with Mike Minogue, Abiomed's Chairman, President and Chief Executive Officer. The format for today's call will be as follows. First, Mike will discuss fourth quarter business and operational highlights, and then I will review our financial results, which were outlined in today's press release. After that, we will open the call to your questions.

謝謝，薩拉。早安，歡迎參加 Abiomed '21 年第四季財報電話會議。我是托德·特拉普，副總裁兼財務長。我和 Abiomed 董事長、總裁兼執行長 Mike Minogue 一起來到這裡。今天電話會議的格式如下。首先，麥克將討論第四季度的業務和營運亮點，然後我將回顧今天的新聞稿中概述的我們的財務表現。之後，我們將打開電話回答您的問題。

Before we begin, I would like to remind everyone that today's call includes forward-looking statements. The company cautions investors that any forward-looking statements involve risks and uncertainties that are not guaranteed in the future. Actual results may differ materially due to a variety of factors identified in our earnings press release and our most recent 10-K and 10-Q filed with the SEC. We do not undertake any obligations to update forward-looking statements.

在開始之前，我想提醒大家，今天的電話會議包含前瞻性陳述。該公司提醒投資者，任何前瞻性陳述都涉及未來無法保證的風險和不確定性。由於我們的收益新聞稿以及我們最近向 SEC 提交的 10-K 和 10-Q 報告中確定的各種因素，實際結果可能會存在重大差異。我們不承擔任何更新前瞻性陳述的義務。

With that, let me turn the call over to Abiomed's Chairman, President and Chief Executive Officer, Mike Minogue.

接下來，讓我將電話轉給 Abiomed 董事長、總裁兼執行長 Mike Minogue。

Thanks, Todd, and good morning, everyone. Throughout the COVID-19 pandemic, Abiomed has remained on course to advance our innovation and become the standard of care for circulatory support. We adapted and executed while successfully transitioning from our red, yellow and green phases to Abiomed 2.0. The 2.0 marks our transformation into a smarter and more connected online medical device company with a COVID playbook. We conduct on-site and online training and education and provide patients support with smart algorithms to track real-world utilization in the cloud, identify best practices and optimize patient care.

謝謝托德，大家早安。在整個 COVID-19 大流行期間，Abiomed 始終致力於推動我們的創新，並成為循環支持護理的標準。我們進行了調整和執行，同時成功地從紅色、黃色和綠色階段過渡到 Abiomed 2.0。 2.0 標誌著我們轉型為更智慧、更互聯的線上醫療設備公司，並擁有應對新冠疫情的策略。我們進行現場和線上培訓和教育，並為患者提供智慧演算法支援，以追蹤雲端中的實際使用情況，確定最佳實踐並優化患者護理。

For the quarter, Abiomed delivered a company record of $241 million in revenue, up 17% year-over-year with double-digit growth and record revenue across the U.S., Europe and Japan. Within the quarter, we saw monthly sequential improvement in both global revenue and patient utilization. Q4 investments continued while achieving a 26% GAAP operating margin. Applying our Abiomed 2.0 COVID playbook, we definitively transitioned to the green phase validated with record number of patients supported in a quarter, in a month, in a week and in a day, all in Q4.

本季度，Abiomed 實現公司創紀錄的 2.41 億美元收入，年增 17%，實現兩位數成長，在美國、歐洲和日本的收入創歷史新高。在本季度內，我們看到全球收入和患者利用率逐月環比改善。第四季的投資繼續進行，同時實現了 26% 的 GAAP 營業利潤率。應用我們的 Abiomed 2.0 COVID 策略，我們最終過渡到了綠色階段，並在第四季度、一個月、一周和一天內支持了創紀錄的患者數量。

Turning to the full fiscal year. Abiomed delivered $848 million in revenue, up 1% year-over-year and 27% operating margin despite the COVID-19 pandemic. We took a disciplined approach to the fiscal year to help us navigate the uncertain environment and achieve our tactical plan. Over the past year, we endured the setbacks of COVID-19 and focused on keeping employees safe, making lifesaving heart pumps and supporting our hospitals and patients. We controlled expenses and invested in innovation, new clinical studies and expanded distribution, while remaining fiscally responsible.

轉向整個財年。儘管受到 COVID-19 大流行的影響，Abiomed 仍實現了 8.48 億美元的收入，年增 1%，營業利潤率達到 27%。我們對本財年採取了嚴格的方法，以幫助我們應對不確定的環境並實現我們的戰術計劃。在過去的一年裡，我們經歷了 COVID-19 的挫折，並專注於確保員工安全、製造救生心臟泵以及為我們的醫院和患者提供支援。我們控制開支並投資於創新、新的臨床研究和擴大分銷，同時保持財務責任。

Our balance sheet strengthened to $848 million in cash, while maintaining 0 debt and acquiring an ECMO platform. In addition, our IP portfolio increased to 1,150 Impella patents and 940 patents pending. We achieved a significant number of regulatory approvals and established world-class online training and education with CAMP PCI. At Abiomed, our Patients First mindset gives us purpose and courage, and we always seek opportunities to lead, manage, adapt and execute. For this fiscal year, I would like to thank our employees and customers for their courage, dedication to patients and leadership throughout the pandemic.

我們的資產負債表現金增加至 8.48 億美元，同時維持零債務並收購了 ECMO 平台。此外，我們的 IP 組合增加至 1,150 項 Impella 專利和 940 項正在申請的專利。我們獲得了大量監管部門的批准，並透過 CAMP PCI 建立了世界一流的線上培訓和教育。在 Abiomed，我們的病人至上的心態給了我們目標和勇氣，我們總是尋求領導、管理、適應和執行的機會。在本財年，我要感謝我們的員工和客戶在整個疫情期間的勇氣、對病人的奉獻和領導。

We exited the year slightly up in revenue, profitable and stronger than ever before. For today's call, I will highlight our fiscal '21 innovation that will drive our success and momentum into our fiscal year '22 goals and beyond. In fiscal year '21, Abiomed launched revolutionary innovation across multiple patient populations, starting with the accelerated rollout of Impella Connect, our remote monitoring capability, allowing us to go live at nearly 1,000 hospitals in the U.S. Currently, 70% of our patients are monitored in the cloud with Impella Connect. No other company in our space provides this level of 24/7 on site, on call and online support. This is particularly meaningful in the COVID environment. We have also expanded our global footprint with Impella Connect at 29 hospitals in Germany and 49 hospitals in Japan.

今年結束時，我們的收入、獲利能力略有上升，而且比以往任何時候都更加強勁。在今天的電話會議中，我將重點介紹我們的 21 財年創新，這些創新將推動我們實現 22 財年目標及以後的成功和動力。在21 財年，Abiomed 在多個患者群體中推出了革命性創新，首先是加速推出我們的遠端監控功能Impella Connect，使我們能夠在美國近1,000 家醫院投入使用。目前，我們70% 的患者都受到監控透過 Impella Connect 在雲端進行。我們領域中沒有其他公司提供這種級別的 24/7 現場、隨叫隨到和線上支援。這在新冠疫情環境下尤其有意義。我們也透過 Impella Connect 在德國的 29 家醫院和日本的 49 家醫院擴大了我們的全球足跡。

Next, the Impella 5.5 with SmartAssist continues to deliver strong results. Within the quarter, our U.S. surgical revenue grew 46% year-over-year as we expanded this device to 53 more sites totaling 211 sites. For the full fiscal year, U.S. surgical revenue grew 44% year-over-year, driven by strength in patient utilization. The Impella 5.5 is a revolutionary product because it is minimally invasive, provides forward flow and is a fully unloading heart pump designed for heart surgeons.

接下來，配備 SmartAssist 的 Impella 5.5 繼續取得強勁成果。在本季度內，隨著我們將該設備擴展到另外 53 個站點（總計 211 個站點），我們的美國手術收入年增 46%。在整個財年，受患者使用量強勁的推動，美國手術收入較去年同期成長 44%。 Impella 5.5 是一款革命性產品，因為它具有微創性、提供正向流量，並且是專為心臟外科醫生設計的完全卸載心臟幫浦。

It is inserted via the axillary artery or directly into the aorta and designed for longer duration support with patient ambulations. The Impella 5.5 has reported comparatively higher survival rates and native heart recovery for the acutely decompensating heart failure patient population, representing an additional 100,000 treatable U.S. patients. Heart surgeons are also enthusiastic about our BTR heart pump first-in-human experience expected in the fourth quarter of this fiscal year.

它透過腋動脈插入或直接插入主動脈，旨在為患者行走提供更長時間的支持。據報道，Impella 5.5 為急性失代償性心臟衰竭患者群體提供了相對較高的存活率和自然心臟恢復率，代表著另外 100,000 名可治療的美國患者。心臟外科醫師也對我們預計在本財年第四季實現的 BTR 心臟幫浦首次人體體驗充滿熱情。

Turning to our Abiomed Breethe Oxy-1 System, we have now treated 20 patients to date at several sites. In March, I visited our Breethe facility in Baltimore, and met a Breethe ECMO patient on support at the nearby University of Maryland Medical Center. The feedback from physicians on this innovative, compact cardiopulmonary bypass system has been positive. Customers highlight the ease of use with the simple intuitive interface and the light portable design allowing for ambulation. We will continue to innovate and plan to optimize this technology with Smart ECPELLA software and connected cloud monitoring.

談到我們的 Abiomed Breethe Oxy-1 系統，迄今為止，我們已在多個地點治療了 20 名患者。今年 3 月，我參觀了位於巴爾的摩的 Breethe 設施，並在附近的馬裡蘭大學醫療中心遇到了一位接受 Breethe ECMO 治療的患者。醫生對這種創新、緊湊的心肺旁路系統的回饋是正面的。客戶強調簡單直覺的介面和允許移動的輕巧便攜式設計的易用性。我們將繼續創新並計劃透過 Smart ECPELLA 軟體和互聯雲監控來優化這項技術。

Moving on to our regulatory progress. We advanced our U.S. FDA early feasibility study for the Impella ECP, a true 9 French heart pump. As a reminder, in early Q4, we received FDA approval for the expansion of the early feasibility study to 20 patients and have enrolled 10 patients to date. The excitement for PROTECT IV is palpable in the heart failure community, and we recently announced our first patient enrolled at Ascension St. John Hospital in Detroit. It is important to note that PROTECT IV was designed by the leaders and best clinical trialists in the field of cardiovascular medicine.

延續我們的監管進展。我們推進了美國 FDA 對 Impella ECP（真正的 9 French 心臟幫浦）的早期可行性研究。提醒一下，在第四季初，我們獲得 FDA 批准將早期可行性研究擴大到 20 名患者，迄今已入組 10 名患者。心臟衰竭社群對 PROTECT IV 的興奮是顯而易見的，我們最近宣布我們的第一位患者在底特律的 Ascension St. John 醫院入組。值得注意的是，PROTECT IV 是由心血管醫學領域的領導者和最佳臨床試驗人員設計的。

It is an on label prospective, multicenter, randomized controlled trial that is designed to provide the level of clinical evidence needed to achieve a global Class I guideline recommendation for Impella in high-risk PCI in the future. The intent of PROTECT IV RCT is to leverage and validate the best practices that we have learned over the past 10 years in the PROTECT series and cVAD studies that led to the exclusive FDA PMA approval of Impella for high-risk PCI. We believe the heart failure communities engagement will propel the PROTECT IV study to be a landmark trial for high-risk PCI overall as a new treatment alternative.

這是一項標籤上的前瞻性、多中心、隨機對照試驗，旨在提供未來高風險 PCI 中 Impella 獲得全球 I 類指南推薦所需的臨床證據。 PROTECT IV RCT 的目的是利用和驗證我們過去 10 年在 PROTECT 系列和 cVAD 研究中學到的最佳實踐，這些研究導致 FDA PMA 獨家批准 Impella 用於高風險 PCI。我們相信，心臟衰竭社區的參與將推動 PROTECT IV 研究成為高風險 PCI 作為新治療替代方案的里程碑式試驗。

In the past, we have defined our current addressable market for high-risk PCI as 121,000 U.S. patients. As a result of the PROTECT IV study, we are directly investing this year in outreach referral programs that we expect will better identify the undertreated population of an additional 319,000 high-risk PCI patients that are turned down for surgery and not referred for Protected PCI treatment due to not being diagnosed or tested for coronary artery disease. Since the PROTECT IV study is on label and spans the heart team, we now estimate our new U.S. addressable patient population for high-risk PCI to be 440,000 patients.

過去，我們將目前高風險 PCI 的目標市場定義為 121,000 名美國患者。 PROTECT IV 研究的結果是，我們今年直接投資於外展轉診計劃，我們預計該計劃將更好地識別另外319,000 名高風險PCI 患者中治療不足的人群，這些患者被拒絕接受手術且未轉診接受受保護PCI 治療由於未診斷或檢測冠狀動脈疾病。由於 PROTECT IV 研究已上市並涵蓋心臟團隊，我們現在估計新的美國可進行高風險 PCI 的患者群體為 44 萬名患者。

For context, 15 million people in the U.S. have coronary artery disease and heart failure, and it causes approximately 1 million deaths per year. Coronary artery disease and heart failure remains the leading cause of death overall and is the #1 cause of death for people with type 2 diabetes. While we will not complete this study in fiscal year '22, we now have line of sight and a path forward to solidify the new standard of care for high-risk PCI with the goal of complete revascularization and improvement in patient quality of life and ejection fraction.

就背景而言，美國有 1500 萬人患有冠狀動脈疾病和心臟衰竭，每年導致約 100 萬人死亡。冠狀動脈疾病和心臟衰竭仍然是整體死亡的主要原因，也是第 2 型糖尿病患者的第一大死因。雖然我們不會在 22 財年完成這項研究，但我們現在已經有了鞏固高風險 PCI 新護理標準的視野和前進道路，目標是完全血運重建並改善患者的生活質量和射血質量分數。

Finally, I want to highlight some of our goals for Abiomed 2.0 fiscal '22 and beyond with investments focused on extending our lead in innovation, advancing Impella clinical evidence and establishing commercial excellence with a premier distribution team. First, we will continue to invest in R&D as we innovate best-in-class heart and lung support technologies that are smaller, smarter and connected to improve ease of use and clinical outcomes. Second, we plan to execute multiple RCTs, including STEMI DTU, PROTECT IV and advance the RECOVER IV cardiogenic shock design with the goal of achieving Class I guidelines overall.

最後，我想強調我們在 22 財年及以後的 Abiomed 2.0 的一些目標，投資重點是擴大我們在創新方面的領先地位、推進 Impella 臨床證據以及與一流的分銷團隊建立商業卓越。首先，我們將繼續投資於研發，創新一流的心肺支援技術，這些技術更小、更聰明、更互聯，以提高易用性和臨床結果。其次，我們計劃執行多項隨機對照試驗，包括 STEMI DTU、PROTECT IV 並推進 RECOVER IV 心因性休克設計，目標是整體實現 I 類指南。

In addition, we expect to further validate the safety and efficacy of Impella and the importance of complete revascularization in high-risk PCI with the publications of PROTECT III and RESTORE EF. For cardiogenic shock, positive clinical results presented yesterday at the SCAI Scientific Sessions for the physician-initiated National Cardiogenic Shock Initiative will be published. Separately, the positive results presented by the MHLW, PVAD, Japanese Heart Committee will also be published.

此外，我們期望透過PROTECT III和RESTORE EF的發表進一步驗證Impella的安全性和有效性以及高風險PCI中完全血運重建的重要性。對於心臟休克，昨天在 SCAI 科學會議上公佈的由醫生發起的國家心臟休克倡議的積極臨床結果將被公佈。另外，MHLW、PVAD、日本心臟委員會提交的正面結果也將公佈。

Because these cardiogenic shock patients are difficult to randomize and consent, our best practice protocols are derived from over 10 years of real-world evidence and over 100,000 patients with physician-initiated and prospective FDA and PMDA studies in the U.S., Europe and Japan. This new paradigm focuses on improved survival and native heart recovery. And finally, through a combination of our U.S. distribution expansion and leveraging CAMP PCI, we plan to deliver best-in-class training and education on-site and online with the goal of identifying patients, improving outcomes and driving Impella adoption.

由於這些心因性休克患者很難隨機分組並獲得同意，因此我們的最佳實踐方案源自10 多年的真實世界證據以及在美國、歐洲和日本對超過100,000 名患者進行的由醫生發起的前瞻性FDA 和PMDA 研究。這種新模式的重點是提高存活率和原生心臟恢復。最後，透過美國分銷擴張和利用 CAMP PCI 相結合，我們計劃提供一流的現場和線上培訓和教育，目標是識別患者、改善結果並推動 Impella 的採用。

Before I conclude, I want to share a patient story. Chris Kirkman, a 48-year-old husband, father and sales director from Zachary, Louisiana has a family history of heart disease and has lived with hypertension for 20 years. In December 2020, after experiencing shortness of breath, fluid buildup around his abdomen and difficulty sleeping, Chris visited a local emergency clinic. He was prescribed medication and sent home. Chris' symptoms gradually became more severe over the next few months. When he experienced trouble breathing, Chris' wife drove him to the local hospital where he was diagnosed with advanced coronary disease and congestive heart failure with poor ejection fraction at 20%.

在結束之前，我想分享一個患者的故事。 Chris Kirkman 是一位來自路易斯安那州扎卡里的 48 歲丈夫、父親和銷售總監，他有心臟病家族史，患有高血壓已有 20 年了。 2020 年 12 月，克里斯出現呼吸短促、腹部積水和睡眠困難等症狀後，前往當地的急診診所就診。他被開了藥並被送回家。在接下來的幾個月裡，克里斯的症狀逐漸變得更加嚴重。當他出現呼吸困難時，克里斯的妻子開車送他去當地醫院，在那裡他被診斷出患有晚期冠心病和充血性心臟衰竭，射血分數僅為20%。

He was told he was too high-risk for bypass surgery and discharged home with a wearable defibrillator. Chris was then referred to interventional cardiologist, Dr. Abraham, at Baton Rouge General - Bluebonnet. Dr. Abraham identified Chris as an appropriate candidate for Protected PCI with Impella. When he returned for the scheduled procedure, Dr. Abraham successfully achieved complete revascularization with the help of Impella CP heart pump, and Chris was discharged home the next day. During his follow-up exam, Chris' ejection fraction improved to 45%. Today, Chris is thankful to be back at work and enjoying a healthier lifestyle with his wife and 3 children.

他被告知他的搭橋手術風險太高，並帶著可穿戴式除顫器出院回家。隨後，克里斯被轉診至巴吞魯日總醫院 - Bluebonnet 的介入性心臟病專家亞伯拉罕博士處。 Abraham 博士認為 Chris 是接受 Impella 保護性 PCI 的合適候選人。當亞伯拉罕醫生返回進行預定手術時，他在 Impella CP 心臟泵的幫助下成功實現了完全血管重建，克里斯第二天就出院回家了。在後續檢查中，克里斯的射血分數提高至 45%。今天，克里斯很高興能夠重返工作崗位，與妻子和 3 個孩子一起享受更健康的生活方式。

In conclusion, I'm very proud of our employees and customers for their dedication and courage during the COVID pandemic. Despite the challenging circumstances on both professional and personal levels, Abiomed 2.0 delivered 1 of our most productive fiscal years in my 17-year tenure as CEO. I am confident that Abiomed will not just be a successful company, but will drive a new standard of care for multiple growing populations of high-risk heart failure patients around the world. We look to the new fiscal year with great excitement because we are a stronger company today and have a clear path for execution to fulfill our heart recovery mission. And last, we sincerely appreciate the continued support from our patients, customers and shareholders.

總之，我為我們的員工和客戶在新冠疫情期間的奉獻精神和勇氣感到非常自豪。儘管專業和個人層面都面臨挑戰，但 Abiomed 2.0 仍然是我擔任執行長 17 年以來最富有成效的財年之一。我相信 Abiomed 不僅會成為一家成功的公司，還將為世界各地不斷增長的高風險心臟衰竭患者群體推動新的護理標準。我們懷著極大的興奮期待新的財年，因為我們今天是一家更強大的公司，並且有明確的執行路徑來完成我們的心臟復健使命。最後，我們衷心感謝患者、客戶和股東的持續支持。

I will now turn the call over to Todd.

我現在將把電話轉給托德。

Thank you, Mike, and good morning, everyone. Now starting with Q4 results. As Mike mentioned, we delivered record revenue of $241 million, an increase of 17% year-over-year with double-digit growth across the U.S., Europe and Japan. We leveraged our Abiomed 2.0 COVID playbook, which allowed us to transition to the green phase, where we grew patients and revenue year-over-year and delivered on our innovation, regulatory and clinical milestones despite the current environment.

謝謝你，麥克，大家早安。現在從第四季的結果開始。正如 Mike 所提到的，我們實現了 2.41 億美元的創紀錄收入，年增 17%，美國、歐洲和日本的收入均達到兩位數成長。我們利用 Abiomed 2.0 COVID 策略，使我們能夠過渡到綠色階段，在當前環境下，我們的患者數量和收入逐年增長，並實現了我們的創新、監管和臨床里程碑。

Turning to our regional performance. U.S. revenue grew 13% to $196 million, driven by a 13% increase in patient utilization. We saw double-digit growth in both high-risk PCI and cardiogenic shock. The pandemic hit peak levels in the first few weeks of January, which impacted patient utilization. However, as COVID cases and related hospitalizations began to decline and we executed our playbook, we delivered sequential improvements in patients and revenue in each month of the quarter. We also set a patient and revenue record in March.

轉向我們的區域表現。由於患者利用率增加 13%，美國營收成長 13%，達到 1.96 億美元。我們看到高風險 PCI 和心因性休克都出現了兩位數的成長。疫情在一月的前幾週達到高峰，影響了病患的就診率。然而，隨著新冠肺炎病例和相關住院人數開始下降，並且我們執行了我們的策略，我們在本季度每個月的患者數量和收入方面都取得了連續改善。我們還在三月創下了病患和收入紀錄。

At the end of our fiscal Q4 in the U.S., the CP is now in 1,509 sites. We have placed the Impella 5.0 in 663 sites, and the Impella 5.5 with SmartAssist is now in 211 sites, up 53 sites versus prior quarter. Lastly, the Impella RP is now in 588 sites, up 19 versus Q3. U.S. reorder performance in the quarter was slightly below 100% and average combined inventory at the hospitals for the Impella 2.5 and CP was 4.7 units per site, consistent with the inventory levels we saw in Q3.

截至美國第四財季末，CP 現已分佈在 1,509 個地點。我們已將 Impella 5.0 部署在 663 個站點中，帶有 SmartAssist 的 Impella 5.5 目前部署在 211 個站點中，比上一季增加了 53 個站點。最後，Impella RP 目前已覆蓋 588 個​​站點，比第三季增加了 19 個。本季美國的再訂購績效略低於 100%，醫院的 Impella 2.5 和 CP 平均綜合庫存為每個地點 4.7 台，與我們在第三季看到的庫存水準一致。

Turning to outside the U.S. In Q4, total revenue was $46 million, up 33% year-over-year, driven by strength in Europe and Japan. Our European revenue increased 28% year-over-year due to higher patient utilization in several markets, such as Germany, Austria and the U.K. and a benefit from the euro-U.S. dollar foreign exchange rate. Similar to the U.S., in Europe, we saw an impact in January, when certain countries mandated lockdowns as COVID cases and deaths accelerated. However, here too, we leveraged the COVID playbook, executed on our plan and delivered monthly sequential improvement throughout the quarter.

轉向美國以外地區，在歐洲和日本業務強勁的推動下，第四季總收入為 4,600 萬美元，年增 33%。由於德國、奧地利和英國等多個市場的患者利用率較高以及受益於歐美市場，我們的歐洲收入較去年同期成長 28%。美元外匯匯率。與美國類似，在歐洲，我們在一月也看到了影響，隨著新冠病例和死亡人數的增加，某些國家強制封鎖。然而，在這裡，我們也利用了新冠疫情行動手冊，執行了我們的計劃，並在整個季度實現了每月的連續改進。

Japan continues to perform very well, delivering $11.6 million in revenue, up 38% year-over-year, driven by patient utilization. We opened 10 new sites in the quarter, bringing our total to 166 sites. Moving forward, gross margin for Q4 was 80.9%, flat compared to the prior year due to benefits from increased production volume, offsetting higher material spend and stock-based compensation. R&D expense totaled $32 million, an increase of 26% from the prior year. The value of our ongoing innovation has been evident throughout the past year, and we believe it will continue to create value as we invest in advancing the Impella ECP, XR Sheath, Breethe Oxy-1 System and Impella BTR and in clinical evidence with PROTECT IV, STEMI DTU and DanGer.

日本繼續表現出色，在患者利用率的推動下，收入達到 1,160 萬美元，年增 38%。本季我們開設了 10 個新站點，使站點總數達到 166 個。展望未來，第四季的毛利率為 80.9%，與前一年持平，這是由於產量增加的好處，抵消了材料支出和股票補償的增加。研發費用總計3,200萬美元，較上年成長26%。我們持續創新的價值在過去的一年中已經顯而易見，我們相信，隨著我們投資推進 Impella ECP、XR 護套、Breethe Oxy-1 系統和 Impella BTR 以及 PROTECT IV 的臨床證據，它將繼續創造價值、 STEMI DTU 與危險。

SG&A expense for the quarter totaled $100 million, up 20% versus prior year. The increase was due to targeted investments we made in expanding our distribution team, incremental advertising and higher stock-based compensation. In the quarter, GAAP operating income grew 8% to $63 million, translating to an operating margin of 26%. The variance versus prior year, again, was driven by growth investments and higher stock-based compensation. Net income for the quarter was $57 million or $1.24 per diluted share versus $0.70 in Q4 '20.

本季的 SG&A 費用總計 1 億美元，比去年同期成長 20%。這一增長是由於我們在擴大分銷團隊、增量廣告和更高的股票薪酬方面進行了有針對性的投資。本季度，GAAP 營業收入成長 8%，達到 6,300 萬美元，營業利益率為 26%。與上一年相比的差異再次是由成長投資和更高的股票薪酬所推動的。該季度的淨利潤為 5,700 萬美元，即稀釋後每股收益 1.24 美元，而 20 年第四季的淨利潤為 0.70 美元。

Net income increased 79%, primarily due to the mark-to-market investment in Shockwave. Shockwave impacted our reported EPS by $0.13 in the quarter. Our balance sheet remains robust. In Q4, we generated $86 million of operating cash flow and approximately $275 million for the year. As a result, we ended the fiscal year with $848 million in cash, up $197 million or 30% versus last year, while remaining debt-free. Our strong balance sheet provides us with stability as well as with flexibility to make continued investments.

淨利潤成長 79%，主要歸功於對 Shockwave 的按市值計價的投資。 Shockwave 對我們報告的本季每股收益造成了 0.13 美元的影響。我們的資產負債表依然穩健。第四季度，我們產生了 8,600 萬美元的營運現金流，全年產生了約 2.75 億美元。結果，我們在本財年結束時擁有 8.48 億美元的現金，比去年增加了 1.97 億美元，即 30%，同時保持無債務狀態。我們強大的資產負債表為我們提供了持續投資的穩定性和靈活性。

Now turning to our full year performance. Throughout the fiscal year, we were agile within the COVID environment, navigating the challenges presented by it, but remain disciplined and executed on our goals. As a result, we saw quarterly improvement in both patients and revenue and delivered global revenue of $848 million, an increase of 1% versus prior year despite the global pandemic. By geography, on a year-over-year basis, the U.S. declined 2%, while Europe and Japan grew 12% and 22%, respectively. GAAP operating income for the fiscal year '21 was $230 million, down 8% compared to the prior year, which equates to a 27.1% operating margin.

現在轉向我們的全年業績。在整個財年中，我們在新冠疫情環境下保持敏捷，應對其帶來的挑戰，但仍保持紀律並執行我們的目標。因此，儘管全球疫情大流行，但我們的患者數量和收入均出現季度改善，全球收入達到 8.48 億美元，比上年增長 1%。按地區劃分，美國年減 2%，而歐洲和日本分別成長 12% 和 22%。 '21 財年的 GAAP 營業收入為 2.3 億美元，比上一年下降 8%，相當於 27.1% 的營業利潤率。

We took a fiscally disciplined approach throughout the year. We controlled discretionary expenses and instituted temporary actions to reduce costs, while investing at record levels in innovation. In fiscal year '21, we invested $122 million in R&D, up 23% year-over-year. Additionally, we added 40 heads to our distribution team within the year with the majority occurring in our fourth quarter. Net income for the year was $226 million or $4.94 per diluted share versus $203 million or $4.43 in the prior year. The 11% increase was primarily driven by our equity investment in Shockwave.

我們全年採取了嚴格的財務紀律。我們控制可自由支配開支並採取臨時行動來降低成本，同時以創紀錄的水平進行創新投資。 21 財年，我們在研發方面的投資為 1.22 億美元，年增 23%。此外，我們在一年內為我們的分銷團隊增加了 40 名負責人，其中大部分是在第四季度完成的。本年度淨利為 2.26 億美元，即每股攤薄收益 4.94 美元，而前一年為 2.03 億美元，即每股攤薄收益 4.43 美元。 11% 的成長主要是由我們對 Shockwave 的股權投資所推動的。

Lastly, turning to our guidance for fiscal year '22. For the full year, we expect revenue to be in the range of $990 million to $1.03 billion which translates to 17% to 22% growth for the year. At the low end, our guidance assumes some continued uncertainty with COVID, namely unevenness and recoveries caused by resurgences, national lockdowns, new strains, vaccine availability and adoption. At the high end of the range, our assumptions include vaccines are broadly distributed, leading to lower new COVID cases in a social and economic return to normalcy, which should have a positive effect on our customers and our business.

最後，轉向我們對 22 財年的指導。我們預計全年營收將在 9.9 億美元至 10.3 億美元之間，即全年成長 17% 至 22%。在低端，我們的指導假設新冠疫情存在一些持續的不確定性，即由疫情死灰復燃、國家封鎖、新毒株、疫苗供應和採用造成的不平衡和恢復。在該範圍的高端，我們的假設包括疫苗的廣泛分發，導致社會和經濟恢復正常時新冠病例減少，這應該對我們的客戶和我們的業務產生積極影響。

As we typically do when issuing guidance, I would like to provide some color on our expectations to the seasonality of our fiscal year. In Q1, we anticipate that utilization will remain uneven as we continue to endure the different transition pace across geographies of resurgences, recovery and vaccinations globally. However, we remain confident in the efficacy of our playbook and execution and our ability to continue to treat patients in this environment and believe revenue in Q1 '22 will be flat to slightly above Q4 '21 revenue of $241 million.

正如我們在發布指導時通常所做的那樣，我想對我們對本財年季節性的預期提供一些說明。在第一季度，我們預計利用率將仍然不平衡，因為我們繼續忍受全球各地復甦、恢復和疫苗接種的不同轉變速度。然而，我們對我們的策略和執行的有效性以及我們在這種環境下繼續治療患者的能力仍然充滿信心，並相信22 年第一季的收入將持平，略高於21 年第四季度的2.41億美元收入。

Historically, Q2 is a seasonally slow quarter for cardiovascular devices due to the summertime slowdown in the cath lab and physician vacations. We believe this could be exasperated this year given the potential vacations and pent-up demand for travel. So we expect Q2 revenue to be flat or slightly below the Q1 pace. As we transition to the back half of the year, we typically see sequential lift in Q3 based on increased hospital activity and physician engagement. And in Q4, our March quarter, we expect to have our best results as we end our fiscal year.

從歷史上看，由於導管實驗室和醫生假期的夏季放緩，第二季度是心血管設備的季節性淡季。我們認為，考慮到潛在的假期和被壓抑的旅行需求，今年這種情況可能會加劇。因此，我們預計第二季營收將持平或略低於第一季。當我們過渡到今年下半年時，我們通常會看到由於醫院活動和醫生參與的增加，第三季的業績會連續上升。在第四季度，也就是我們三月份的季度，我們預計在財政年度結束時將取得最好的業績。

Turning to operating margin. We expect our fiscal year '22 margin to be in the range of 24% to 26% as we step up targeted investments in innovation, clinical evidence and distribution. A significant portion of our incremental investment will be in R&D as we innovate best-in-class heart and lung support technologies and further validate the safety and efficacy of Impella with multiple ongoing randomized controlled trials. We also plan to expand our distribution, accelerate marketing initiatives and grow our training and education programs.

轉向營業利潤率。隨著我們增加對創新、臨床證據和分銷的針對性投資，我們預計 22 財年的利潤率將在 24% 至 26% 之間。我們增量投資的很大一部分將用於研發，因為我們創新一流的心肺支援技術，並透過多項正在進行的隨機對照試驗進一步驗證 Impella 的安全性和有效性。我們還計劃擴大我們的分銷範圍，加快行銷計劃並擴大我們的培訓和教育計劃。

In summary, fiscal year '21 was a challenging, but very productive year for us as we endured the pandemic and transitioned to Abiomed 2.0. We are pleased to have delivered year-over-year top line growth, achieved GAAP operating margin of 27% and increased our cash to $848 million all while continuing to make necessary investments to drive Abiomed's long-term sustainable growth. We have come through an exceptionally challenging year. I am proud of our employees around the globe for their commitment and hard work and for their accomplishments. I am very excited for the year ahead as we continue to build the new field of heart recovery.

總之，21 財年對我們來說是充滿挑戰但又非常有成效的一年，因為我們經歷了疫情並過渡到 Abiomed 2.0。我們很高興實現了同比增長，實現了 27% 的 GAAP 營業利潤率，並將我們的現金增加到 8.48 億美元，同時繼續進行必要的投資，以推動 Abiomed 的長期可持續增長。我們度過了極具挑戰性的一年。我為我們全球員工的奉獻精神、辛勤工作和所取得的成就感到自豪。我對未來的一年感到非常興奮，因為我們將繼續建立心臟復健的新領域。

Operator, please now open the line for questions.

接線員，現在請撥打電話提問。

(Operator Instructions) Our first question comes from the line of Margaret Kaczor with William Blair.

（操作員說明）我們的第一個問題來自瑪格麗特·卡佐爾和威廉·布萊爾的對話。

I wanted to start a little bit with guidance and a then bigger picture question. So first, can you provide any more clarity on March and April? And then as we look at kind of the Q1 comments that you made, Todd, it looks like historically, maybe you're up 1%, as high as 6% the last several years. I mean given that we're kind of on the back end of the recovery and you're moving into the green phase, why should we assume that Q1 maybe there's a little bit better than that given what we had seen in Q4?

我想從一些指導開始，然後提出一個更大的問題。首先，您能否更清楚地介紹一下三月和四月的情況？然後，當我們查看您在第一季發表的評論時，托德，從歷史上看，您的股價可能上漲了 1%，過去幾年高達 6%。我的意思是，考慮到我們正處於復甦的後期，並且正在進入綠色階段，考慮到我們在第四季度看到的情況，為什麼我們應該假設第一季可能會比第四季好一點呢？

Thanks, Margaret, for the question. So if you think about the progression in Q4, we did start off a fairly soft in January that we highlighted on our last call. And then we did see sequential improvement in February and March. I would tell you, if you look at just our high-risk PCI performance in March, you could make an argument that there was a little bit of bolus from procedures that were deferred, I would say, in December into January. So as it looks from an April perspective, we're not going to provide April actual performance at this point in time. I think we have factored that into the color we provided about Q1 in our prepared remarks that it would be flat to slightly above Q4. But ultimately, we think that makes sense at this point in time so based on what we've seen so far in April.

謝謝瑪格麗特提出的問題。因此，如果你考慮第四季度的進展，我們在一月份的開局確實相當疲軟，我們在上次電話會議中強調了這一點。然後我們確實看到了二月和三月的連續改善。我想告訴你，如果你只看一下我們 3 月份高風險 PCI 的表現，你可以說，有一點推注手術被推遲到了 12 月到 1 月。因此，從四月的角度來看，我們目前不打算提供四月份的實際表​​現。我認為我們已經將這一點納入我們在準備好的評論中提供的有關第一季的顏色中，即它將持平或略高於第四季度。但最終，根據我們四月迄今所看到的情況，我們認為目前這是有意義的。

Okay. Yes. And then in terms of the -- at least relative to our numbers, 5.0, 5.5 seems to do really, really well. Any kind of color you can give there, differences in utilization of accounts, maybe to upgrade the 5.5 from 5.0? Or are you going deeper in accounts given these product improvements?

好的。是的。然後就 - 至少相對於我們的數字而言，5.0、5.5 似乎做得非常非常好。您可以在那裡提供任何類型的顏色，帳戶利用率的差異，也許從 5.0 升級到 5.5？或者考慮到這些產品的改進，您是否會更深入地了解客戶？

Yes. I mean Mike's comments that 5.5, our surgical business, was up over 40% in the quarter. So it continues to perform very well. We're in over 200 hospitals today. We expect that to continue. If you look at our patients, our patients are up substantially as well on 5.5. It's a great product, and I expect to see that momentum continue into fiscal year '22.

是的。我指的是 Mike 的評論，我們的外科業務 5.5 本季成長了 40% 以上。所以它繼續表現得很好。目前我們已在 200 多家醫院開展業務。我們預計這種情況會持續下去。如果你看看我們的患者，我們的患者也大幅上升到 5.5。這是一款很棒的產品，我預計這種勢頭會持續到 22 財年。

Okay. And just kind of last one, again, kind of a little bit bigger picture. You guys have a lot of things out that you're investing in right now, whether it's the RCTs, you've got the ECMO platform, even the Shockwave investment on the side. There's a lot going on, ECP and the rest. As you think about kind of the next 2 to 3 years, how do you outline those various types of opportunities? And what's the next thing that you're going to spend your cash on?

好的。最後一個，再一次，有點更大的圖像。你們現在有很多東西正在投資，無論是 RCT、ECMO 平台，甚至還有 Shockwave 投資。 ECP 和其他方面正在發生很多事情。當您考慮未來 2 到 3 年時，您如何概述這些不同類型的機會？您接下來要花錢的是什麼？

So, Margaret, this is Mike. Thanks for the question. On the big picture, we come out of COVID-19 all in on innovation, on clinical research and on distribution. And so I think you're going to continue to see that in the tactical execution. For innovation, you're going to continue to see the execution of these new products that are revolutionary, ECP, the Impella Connect, ECMO, ECPELLA, 5.5, bridge to recovery. I mean these are -- this is the new innovation that's going to take heart failure and focus it on heart recovery. For clinical research, we're now taking all the studies and the leverage that we've done and we posted a summary of the clinical studies on a slide in our -- on the website.

瑪格麗特，這是麥克。謝謝你的提問。從大局來看，我們在應對新冠肺炎 (COVID-19) 疫情之後，全力投入創新、臨床研究和分銷。所以我認為你會繼續在戰術執行中看到這一點。在創新方面，您將繼續看到這些革命性新產品的執行，ECP、Impella Connect、ECMO、ECPELLA、5.5、恢復的橋樑。我的意思是，這是一項新的創新，它將治療心臟衰竭，並將重點放在心臟復健上。對於臨床研究，我們現在正在利用我們所做的所有研究和槓桿作用，並在網站上的幻燈片上發布了臨床研究的摘要。

But it's just we've learned now how to optimize high-risk PCI. We've learned how to optimize cardiogenic shock, and we've learned how to optimize survival and return to baseline for acute on chronic heart shock. So these are the cardiomyopathy patients. And so those are the things we're working on. We think we're going to further our lead across the board. And of course, we're going to solidify our patent position as we go. So we're very excited because as I said in my prepared remarks, I do think we will have the path forward and create a new standard of care for high-risk PCI, for STEMI, for cardiogenic shock and for heart failure overall. So we're excited to be where we are coming out of the year.

但我們現在才知道如何優化高風險 PCI。我們已經學會如何優化心因性休克，我們也學會如何優化急性或慢性心因性休克的生存率並恢復到基線。這些都是心肌病變患者。這些就是我們正在努力的事情。我們認為我們將進一步全面領先。當然，我們將不斷鞏固我們的專利地位。所以我們非常興奮，因為正如我在準備好的發言中所說，我確實認為我們將有前進的道路，並為高風險 PCI、STEMI、心臟休克和整體心臟衰竭制定新的護理標準。因此，我們很高興能夠達到今年的目標。

Our next question comes from the line of Chris Pasquale with Guggenheim.

我們的下一個問題來自克里斯·帕斯誇萊與古根漢的對話。

Congrats on a nice finish to the year. A couple of questions. One, just, Todd, circling back on the margin guidance. That's down, obviously, from FY '21, down quite a bit from where you guys were in '19 and '20. I appreciate the investment. You guys got some clinical trials starting to ramp up here. But we're also coming off of a year in which R&D spending increased quite a bit. So just curious on the other elements of the investment there. What are you doing from a distribution standpoint that's different and will require a significant step-up? And do you view this as a 1-year drop into profitability? And then you would start to see leverage again? Or is this a multiyear phase you're entering into?

恭喜您今年取得了良好的成績。有幾個問題。一，托德，回到利潤指引。顯然，這個數字比 21 財年有所下降，比你們 19 和 20 財年的水準下降了很多。我很欣賞這項投資。你們這裡開始進行一些臨床試驗。但我們也經歷了研發支出大幅增加的一年。所以只是對那裡投資的其他要素感到好奇。從發行的角度來看，您正在做什麼不同的、需要重大改進的事情？您是否認為這會導致獲利能力下降一年？然後你會再開始看到槓桿作用嗎？或者這是您正在進入的多年階段？

Yes. Thanks for the question, Chris. When I think about our investments for this year, I mean, we're all in on our, what I would call, growth enhancing investments. So it's innovation, it's clinical evidence and it's distribution. So when you think about innovation, it's smaller, smarter, more connected devices, ECP, the expandable sheaths, the AI algorithms, think about the investments we're making in BTR, which again would open up another 100,000 patient population for us for heart failure and then continued investment in Breethe.

是的。謝謝你的提問，克里斯。當我想到我們今年的投資時，我的意思是，我們都投入了我所說的促進成長的投資。所以這是創新、臨床證據和分佈。因此，當你想到創新時，它是更小、更聰明、連接性更強的設備、ECP、可擴展護套、人工智慧演算法，想想我們在BTR 上的投資，這將再次為我們開闢另外10 萬名心臟病患者族群。失敗後繼續投資 Breethe。

When I look at clinical evidence, it's really STEMI, PROTECT IV, the early feasibility study with ECP. I look at these as more digital events that require investment. They're not really long term investments in R&D. So I think over time, you'll see R&D as a percentage of sales will moderate as we execute on our trials. And then the third big bucket is around distribution. We are expanding our distribution team, Chris. We are -- we -- if you went back and looked at our performance over COVID, we noticed that the smaller regions tended to perform better than some of our larger regions. So we've made the decision to go from 17 regions in the United States to 23.

當我查看臨床證據時，它實際上是 STEMI、PROTECT IV、ECP 的早期可行性研究。我將這些視為更多需要投資的數位活動。它們並不是真正的研發長期投資。因此，我認為隨著時間的推移，隨著我們執行試驗，您會看到研發佔銷售額的百分比將會下降。第三個大桶子是關於分銷的。我們正在擴大我們的分銷團隊，克里斯。我們－如果你回顧我們在新冠疫情期間的表現，你會發現較小的地區往往比一些較大的地區表現得更好。因此我們決定將美國的 17 個地區增加到 23 個。

We've started making that investment in Q4. You'll see a little bit more of that investment in Q1. So we are expanding our distribution team, putting more feet on the street and having more local leadership. We are expanding advertising on our direct-to-patient initiatives that Mike highlighted in his comments, again, targeting that 319,000 untreated population, utilizing PROTECT IV. And then we're going to be doing a little bit more trade shows and education. So I think some of it in R&D and most of it in R&D is going to be, I would say, temporary over the next year or 2. It's a big investment year for us. With that said, at our operating margin guidance of 24% to 26%, midpoint of 25%, is still pretty strong given the fact that we're driving 17% to 22% top line growth.

我們已在第四季開始進行這項投資。您會在第一季看到更多的投資。因此，我們正在擴大我們的分銷團隊，將更多的精力投入街頭並擁有更多的當地領導力。我們正在擴大針對直接面向患者的舉措的廣告，麥克在評論中再次強調了這一點，利用 PROTECT IV 瞄準了 319,000 名未經治療的人群。然後我們將進行更多的貿易展覽和教育。因此，我認為研發中的一部分，以及研發中的大部分，我想說，在未來一兩年內將是暫時的。這對我們來說是一個巨大的投資年。話雖如此，考慮到我們正在推動 17% 至 22% 的營收成長，我們的營業利潤率指引為 24% 至 26%（中間值為 25%），仍然相當強勁。

That's helpful. And then maybe just to follow-on there. You touched on this direct-to-consumer initiative, trying to get at some of these broader population of patients who could be appropriate for high-risk PCI. But you're talking about patients who are undiagnosed, which always brings up questions about really the feasibility of getting at that type of population. It's not as if we're not looking for heart disease in this country. So how realistic is it to really bring those patients into the fold, especially since penetration of Impella supported PCI within the diagnosed population is still relatively low today?

這很有幫助。然後也許只是繼續下去。您談到了這項直接面向消費者的舉措，試圖吸引一些可能適合高風險 PCI 的更廣泛的患者群體。但你談論的是未確診的患者，這總是會引發關於接觸這類人群的可行性的問題。在這個國家，我們並不是不尋找心臟病。那麼，真正將這些患者納入其中有多現實，特別是因為目前 Impella 支持的 PCI 在診斷族群中的普及率仍然相對較低？

Chris, that's a good question and very insightful relative to why high-risk PCI still remains out there. If you look at TAVR, when they started, they went out and identified the patients that were surgical turndowns. They weren't considered for the cath lab because they didn't have the technology. The same is true with mitral as well as the WATCHMAN. When PROTECT II started, none of those patients went to the cath lab, and nearly all those patients had already been turned down for surgery, but not considered for high-risk PCI. The exciting thing about PROTECT IV and the engagement of the heart failure community and heart failure cardiology specifically is they don't consider PCI in general practice. And what they really look at is optical medical management or the invasiveness of a surgery, which many of these patients are turned down.

Chris，這是一個很好的問題，對於為什麼高風險 PCI 仍然存在非常有洞察力。如果你看看 TAVR，當他們開始時，他們就出去識別那些拒絕接受手術的病人。他們沒有被考慮進入導管實驗室，因為他們沒有技術。二尖瓣和守望者也是如此。當 PROTECT II 開始時，這些患者都沒有去導管室，幾乎所有患者都被拒絕接受手術，但沒有考慮進行高風險 PCI。 PROTECT IV 以及心臟衰竭社區和心臟衰竭心臟病學的參與的令人興奮的事情是，他們在一般實踐中不考慮 PCI。他們真正關注的是光學醫療管理或手術的侵入性，其中許多患者都拒絕了。

So moving forward, because they're involved in the design of PROTECT IV -- and as 1 physician described it the other day in a broad presentation. He said that PROTECT IV is essentially a heart failure study. And what it does is it opens up another therapy for this growing population, these type 2 diabetes patients, that have poor ejection fraction. They don't want or they're turned down for surgery. And you can see a benefit with Protected PCI. What's unique about and what's new is that our Protected PCI patients show an improvement in their quality of life and show an improvement in their ejection fraction in 90 days. And so that's what's unique.

所以向前邁進，因為他們參與了 PROTECT IV 的設計——正如一位醫生前幾天在一次廣泛的演講中所描述的那樣。他說PROTECT IV本質上是一項心臟衰竭研究。它的作用是為不斷增長的射血分數較差的 2 型糖尿病患者開闢另一種治療方法。他們不願意或被拒絕接受手術。您可以看到 Protected PCI 的優勢。獨特之處和新穎之處在於，我們的受保護 PCI 患者的生活品質得到了改善，並且射血分數在 90 天內得到了改善。這就是獨特之處。

And now that we look at the historic trends, when people do show up in the hospitals, they usually -- for these types of cases, they only look at it -- at the -- and try to look for coronary disease around 17% of the time. And it's less than 5% of the time that people are actually getting revascularization in the index admission. So there's a lot of opportunity there. And it's not anyone's fault. It's just that the heart failure community has not been looking at or considering a Protected PCI solution because in the past, PCI did not improve EF. That was only done with open heart surgery, with CABG. Moving forward, that's something we've been able to show in multiple FDA studies, PROTECT II, PROTECT III and also in RESTORE EF. And that will be the gain. And I believe that's why heart failure -- the heart failure community overall will get engaged.

現在我們來看看歷史趨勢，當人們確實出現在醫院時，他們通常 - 對於這些類型的病例，他們只會看 - 並嘗試尋找大約 17% 的冠心病的時間。人們在入院時實際接受血管重建的幾率不到 5%。所以那裡有很多機會。這不是任何人的錯。只是心臟衰竭社群一直沒有關注或考慮受保護的 PCI 解決方案，因為在過去，PCI 並沒有改善 EF。這只能透過心臟直視手術（CABG）來完成。展望未來，我們已經在多項 FDA 研究、PROTECT II、PROTECT III 以及 RESTORE EF 中證明了這一點。這就是收穫。我相信這就是心臟衰竭的原因——整個心臟衰竭社區都會參與其中。

Our next question comes from the line of Anthony Petrone with Jefferies.

我們的下一個問題來自 Anthony Petrone 和 Jefferies 的對話。

Congratulations on the quarter. Hope everyone is doing well. I have 1 on reimbursement and 1 on PROTECT IV. The first 1 on reimbursement is just sort of a rehash and a recap of the IPPS proposals from earlier this week, maybe specifically on the proposal -- the recommendation to shift high-risk PCI, add 215 to adjoining codes. Maybe just how sort of you're viewing that? It seems overall that this actually cleans up reimbursement going forward and maybe perhaps streamlines the process in future rounds. So maybe just some views there. And then I'll have a follow-up on PROTECT IV.

恭喜本季。希望每個人都做得很好。我有 1 個報銷項目和 1 個 PROTECT IV 項。關於報銷的第一個 1 只是本週早些時候 IPPS 提案的重述和回顧，也許專門針對該提案——轉移高風險 PCI 的建議，向相鄰代碼添加 215。也許你對此有何看法？總的來說，這實際上清理了未來的報銷，並可能簡化未來幾輪的流程。所以也許只是一些觀點。然後我將對 PROTECT IV 進行後續報道。

Anthony, thanks for the question on CMS and the reimbursement. We agree with your comments. We're pleased, and we believe it now provides a permanent solution. What we've always talked about is that Impella is a platform with multiple patients. And so we position the products and the reimbursement and even in the future some of the pricing. You have a 4-hour pump or procedure. That's a high-risk PCI. You've got a 4-day patient. That's the cardiogenic shock patient in the ICU on Impella Connect with smart algorithms. And you've got this acute on chronic shock patient, that's a 4-month -- up to a 4-month potential patient with the 5.5 and future BTR pump. So it definitely aligns completely what we're doing. So it allows for the differentiation for the type of resources and support that we provide.

安東尼，感謝您提出有關 CMS 和報銷的問題。我們同意您的意見。我們很高興，我們相信它現在提供了一個永久的解決方案。我們一直在談論的是 Impella 是一個擁有多個患者的平台。因此，我們對產品和報銷，甚至未來的一些定價進行了定位。您有 4 小時的幫浦或手術。這是高風險的 PCI。你有一個住院 4 天的病人。這是 ICU 中使用 Impella Connect 智慧演算法的心因性休克患者。對於慢性休克患者來說，這是一個急性發作，這是一個 4 個月甚至 4 個月的潛在患者，使用 5.5 和未來的 BTR 幫浦。所以它絕對與我們正在做的事情完全一致。因此，它允許我們提供不同類型的資源和支援。

We do think it's a permanent -- more permanent solution. And it also really aligns with our hub-and-spoke strategy. As Todd mentioned, we saw that -- when COVID hit, we saw bigger growth in the small to mid-sized hospitals and regions. So we went a little bit leaner and a little bit faster by adding more regions and more team approaches. But we also saw in March a massive swing back in the large centers. And so part of that has to do with our hub-and-spoke coordination. Where if a patient ends up in any cath lab, we're going to know about it. We're going to be there to support. We'll be in the cloud watching. But then we can also help monitor and work together the top centers that do the most complex work with the spoke centers. And what CMS also did was slightly increase our DRG 268, which allows those outlying hospitals to place the Impella, stabilize the patient and then make the decision if they want to send them to the high end center.

我們確實認為這是一個永久的、更永久的解決方案。它也確實符合我們的中心輻射策略。正如托德所提到的，我們看到，當新冠疫情來襲時，我們看到中小型醫院和地區出現了更大的增長。因此，我們透過增加更多區域和更多團隊方法，變得更精簡、更快。但我們在三月也看到了大型中心的大幅回落。因此，這在一定程度上與我們的軸輻式協調有關。如果患者最終進入任何導管實驗室，我們都會知道。我們將在那裡提供支援。我們將在雲端觀看。但我們也可以幫助監控頂級中心，並與輻條中心一起完成最複雜的工作。 CMS還做了一點，就是稍微增加我們的DRG 268，讓那些邊遠的醫院可以放置Impella，穩定病人的情況，然後再決定是否要把他們送到高端中心。

The last piece of this has to do with our distribution. We are going to maintain this distribution overall in all the cath labs but we do have a dedicated team now that's a heart recovery team that's working directly with the heart surgeons and the heart failure cardiologists. We think that will help with the referral network. But it will also allow us to go deeper to those transplant centers. There are about 140 of them that really do the most advanced work and those chronic patient care that we're excited now to bring 5.5 BTR. And RP did rebound also well in this quarter. We're going to put SmartAssist on RP. So we'll now get some of the information on a biventricular patient that has never existed, and we're going to make further improvements to the RP to ensure that the surgeons also have a way to utilize it. So lots of good things happening with CMS. We appreciate the work and the thoughtfulness that they put in to the final rule.

最後一部分與我們的發行版有關。我們將在所有導管實驗室中保持這種分佈，但我們現在確實有一個專門的團隊，這是一個心臟恢復團隊，直接與心臟外科醫生和心臟衰竭心臟病專家合作。我們認為這將有助於推薦網路。但這也將使我們能夠更深入地了解這些移植中心。其中大約有 140 個真正從事最先進的工作和長期患者護理，我們現在很高興能帶來 5.5 BTR。 RP 在本季也確實反彈良好。我們將把 SmartAssist 放在 RP 上。因此，我們現在將獲得一些從未存在過的雙心室患者的信息，並且我們將對 RP 進行進一步改進，以確保外科醫生也有辦法利用它。 CMS 發生了很多好事。我們感謝他們為最終規則所做的工作和深思熟慮。

That's very helpful. And my follow-up on PROTECT IV would be maybe just a broader view here and a sense on timing. It looks like you're targeting over 1,200 patients, 100 sites in Europe, U.S. So I just want to get a sense of timing on enrollment. And then maybe a question on the design, looking at Dr. Gregg Stone, the lead PI. He mentions obviously the goal here is to operate on more complex cases and perform more complex revascularization. And Mike, it brings me back to PROTECT II when there was the rotational atherectomy arm. And so can you give us a sense if there will be cohorts based on specific surgeries and sort of how that will sort of evolve as the study gets underway?

這非常有幫助。我對 PROTECT IV 的後續行動可能只是更廣泛的視野和對時機的掌握。看來您的目標是超過 1,200 名患者，位於歐洲和美國的 100 個地點，所以我只是想了解登記的時機。然後也許是一個關於設計的問題，看看首席 PI 格雷格·斯通 (Gregg Stone) 博士。他顯然提到這裡的目標是對更複雜的病例進行手術並進行更複雜的血管重建。麥克，這讓我想起了 PROTECT II，當時還有一個旋磨術臂。那麼，您能否讓我們了解是否會有基於特定手術的隊列，以及隨著研究的進行，隊列將如何演變？

So Anthony, the PROTECT IV study timing -- we're not giving specific timing right now just because we want to get a few months away from the transition with the vaccines. We have described in detail the study. Dr. Chuck Simonton did a webcast on it last year. So that's still up on our Investor page, and we'll give more details. But to your specific question, on the design, think of it as an on-pump PCI, which is the Impella supported PCI versus off-pump PCI, which is where the majority of these patients today -- they actually don't get a balloon pump. They get the in and out approach where the physician has to inflate the balloon and replace stent quickly or otherwise the hemodynamics will collapse, or they stage the patient or they do a combination of things or they limit the contrast because they're worried about acute kidney injury.

安東尼，PROTECT IV 研究的時間安排——我們現在沒有給出具體的時間安排，只是因為我們希望距離疫苗的過渡還有幾個月的時間。我們已經詳細描述了這項研究。查克·西蒙頓博士去年對此進行了網路廣播。所以這仍然在我們的投資者頁面上，我們將提供更多詳細資訊。但對於你的具體問題，在設計上，將其視為體外循環 PCI，即 Impella 支持的 PCI 與非體外循環 PCI，這是當今大多數患者的情況 - 他們實際上沒有得到氣球泵。他們採用進出方法，醫生必須快速為球囊充氣並更換支架，否則血流動力學就會崩潰，或者他們對患者進行分期，或者他們採取多種措施，或者因為擔心急性發作而限制對比腎損傷。

So there will be patients that they will have the option to use a balloon pump and they know that today. That's partly why they don't necessarily use it today because for many people it's not something that's going to provide hemodynamic support if the patient gets in trouble. And the majority of these patients today are in and out. What PROTECT II showed and other studies with Impella showed is that these patients that when they get complete revascularization, with Impella support, we've been able to demonstrate significant improvements in the ejection fraction or the quality of life of these patients at 90 days.

因此，有些患者可以選擇使用氣球泵，他們今天也知道這一點。這就是為什麼他們今天不一定會使用它的部分原因，因為對於許多人來說，如果患者遇到麻煩，它不會提供血液動力學支持。如今，這些患者中的大多數都在進出。 PROTECT II 和其他 Impella 研究表明，當這些患者在 Impella 支持下進行完全血管重建時，我們已經能夠證明這些患者在 90 天時的射血分數或生活品質有顯著改善。

Most recently, that was presented in the RESTORE EF and with the PROTECT III study also showed is lower adverse events on bleeding. So we've made great progress on access closure. But we're also seeing that the physicians are doing a better job leaving less ischemia. And when they do that, that's where you really see the benefit for the patient. In the past, CABG did and does get an improvement in EF because what they're doing is taking a clean vein and rerouting the blood flow. So there's an improvement in EF. But there is a price to pay with the sternotomy and the pump run and the recovery for an open heart surgery.

最近，RESTORE EF 中提出了這一點，PROTECT III 研究也顯示出血不良事件較低。所以我們在訪問關閉方面取得了很大進展。但我們也看到醫生做得更好，缺血更少。當他們這樣做時，你才能真正看到患者受益。過去，CABG 確實取得了 EF 的改善，因為他們所做的是清潔靜脈並重新引導血流。所以EF有改進。但心臟直視手術的胸骨切開術、幫浦運轉和恢復是要付出代價的。

And so in the end, what we -- what we'll have here is a design study that will be able to track everything in terms of quality of life, heart failure, readmissions, improvement in EF. And it's really a comprehensive heart failure study designed by the trialists, and it will have an adaptive design. But we feel very comfortable that the physicians know the patients are out there, and they're excited to work with their referral network. And we're very excited that this is going to -- this is an on label study. So we're excited to get out there and start identifying these patients.

所以最後，我們將進行一項設計研究，它將能夠追蹤生活品質、心臟衰竭、再入院、EF 改善等方面的一切。這確實是一項由試驗者設計的綜合性心臟衰竭研究，並且將具有適應性設計。但我們感到非常放心，因為醫生知道病人就在那裡，他們很高興與他們的轉診網絡合作。我們非常興奮，這是一項標籤研究。因此，我們很高興能夠走出去並開始識別這些患者。

Our next question comes from the line of Chris Cooley with Stephens.

我們的下一個問題來自克里斯·庫利和史蒂芬斯的對話。

Congratulations on a very strong finish to unprecedented year. If I could maybe just start with a question on the international opportunities. In the past, you've updated us a little bit about potential new markets to enter, and I've realized that you're still very low rates of penetration, sub 20%, sub 5% when we think about Europe and Japan. But if you could just walk us through how you see the international market expansion taking place and also reconcile your slide on patient growth and revenue performance? You show a 12% sequential increase in Japan in the most recent quarter and maybe it's a typo, but a 4% sequential decline in revenues. So maybe you could just help us with that. And then I've got a quick follow up.

恭喜您以優異的成績為前所未有的一年畫上了圓滿的句點。我可以先問一個關於國際機會的問題嗎？過去，您向我們介紹了一些有關潛在新市場的最新情況，我意識到，當我們考慮歐洲和日本時，您的滲透率仍然非常低，低於 20%，低於 5%。但是，您是否可以向我們介紹您如何看待國際市場的擴張，並協調您在患者成長和收入表現方面的幻燈片？您顯示日本最近一個季度的營收季增了 12%，這可能是拼字錯誤，但收入卻較上季下降了 4%。所以也許你可以幫助我們。然後我得到了快速跟進。

Thanks, Chris, for the question. In terms of -- I'll take the first part in terms of the Japanese performance in the fourth quarter. Obviously, it continues to perform very well, over $11.5 million. Patients in Japan for the quarter was up 50%. Revenue didn't grow as much, was down sequentially. And really, the function is simple, is we opened up 4 fewer sites in Japan this quarter versus what we did last year. It was about 10 sites this quarter. I think it was 14 sites last quarter. And so that's really what's driving, I would say, a little bit of a disconnect between patients in revenue in Japan. So overall, very strong performance, up 50%. Now your second question was around just countries outside of...

謝謝克里斯提出這個問題。在第一部分中，我將討論日本隊在第四季的表現。顯然，它的表現仍然非常出色，超過 1150 萬美元。本季度日本患者數量增加了 50%。收入沒有成長那麼多，而是連續下降。事實上，功能很簡單，就是本季我們在日本開設的站點比去年少了 4 個。本季大約有 10 個站點。我認為上季有 14 個站點。我想說，這確實是導致日本患者之間收入脫節的原因。總體而言，表現非常強勁，上漲了 50%。現在你的第二個問題是關於...之外的國家

Yes. No, I was just -- yes, so just kind of curious about incremental markets and your thoughts there on timing.

是的。不，我只是——是的，所以只是對增量市場以及你對時機的想法感到好奇。

Yes. Chris, the PROTECT IV is a European study as much as it is a U.S. So the co-PI is an academic leader and recognized trialist. We've had strong growth and publications from Italy. So the interventional cardiology society in Italy has been very active with publications, registry data. That's the -- that was recently presented and published last quarter, showing the benefits of Impella with high-risk PCI and higher survival by placing the Impella before the PCI and achieving complete revasc. We are seeing a lift in Europe overall. We're starting to enter some of these other markets, and many of these top centers have expressed interest and will likely be in PROTECT IV.

是的。 Chris，PROTECT IV 既是一項歐洲研究，也是一項美國研究，因此聯合 PI 是一位學術領導者和公認的試驗者。我們在義大利有強勁的成長和出版物。因此，義大利介入性心臟病學會在出版品、註冊資料方面一直非常活躍。這就是上季度最近提出和發布的，透過將 Impella 置於 PCI 之前並實現完全復甦，展示了 Impella 對高風險 PCI 和更高生存率的好處。我們看到歐洲整體有所提升。我們正開始進入其中一些其他市場，其中許多頂級中心已經表達了興趣，並且很可能會加入 PROTECT IV。

Relative to Asia, we remain focused on -- Japan is the priority, but we also are planting seeds. And again, top centers in Asia are starting to enter into the Impella training and focus on heart recovery. So we think there'll be more there, but we also don't want to lose focus that the 3 biggest drivers for global standard of care and for our execution remain U.S., Germany and Japan.

相對於亞洲，我們仍然專注於——日本是優先事項，但我們也在播種。亞洲的頂級中心再次開始參加 Impella 訓練並專注於心臟恢復。因此，我們認為還會有更多，但我們也不想失去關注，全球護理標準和我們執行的三大驅動因素仍然是美國、德國和日本。

And if I could just maybe squeeze 1 other quick 1 in here. Just when you think about the expansions here in the United States from 17 to 23 regions, conceptually it makes sense. You're closer to the customer, more frequent visits. They're helping drive greater growth in those territories. Curious though, are you seeing similar types of trends in both high-risk PCI and the shock patient populations? And also just as we see more patients on Impella Connect, help us kind of understand what this -- how the distribution is really doing out there in the field? Just kind of want to get a better feel for what kind of lift you are seeing as you expand from 17 to 23.

如果我能把另外 1 個快速的 1 擠到這裡就好了。當你想到美國從 17 個地區擴展到 23 個地區時，從概念上講這是有道理的。您與客戶的距離更近，拜訪頻率更高。他們正在幫助推動這些地區的更大成長。但好奇的是，您是否在高風險 PCI 和休克患者群體中看到了類似的趨勢？而且，正如我們在 Impella Connect 上看到更多患者一樣，請幫助我們了解這是什麼——分發在現場的實際情況如何？只是想更了解當您從 17 歲增加到 23 歲時您會看到什麼樣的提升。

Chris, the design of our distribution and what's happened out there is really part of the COVID playbook. So on the COVID playbook, we're tracking weekly access to the hospital's ICU capacity, Impella Connect. And then we do see a flip back and forth between the high-risk PCI patients and the shock patients. We know if shock or pulmonary embolism or ECPELLA and those things go up, the ICUs fill up. That means that we're going to have a bit of a delay in high-risk PCI at the big centers, but that bolus will come back. The interesting element of that is our smaller and midsized territories and hospitals. They did not see that dip as much because they then potentially do that patient and they don't refer that patient to the larger center.

克里斯，我們發行版的設計以及那裡發生的事情確實是新冠病毒策略的一部分。因此，在 COVID 手冊中，我們每週追蹤醫院 ICU 容量 Impella Connect 的訪問情況。然後我們確實看到高風險 PCI 患者和休克患者之間來回翻轉。我們知道，如果休克、肺栓塞或 ECPELLA 等情況加重，加護病房就會擠滿人。這意味著我們在大型中心的高風險 PCI 治療將會有一些延遲，但這種推注將會回來。其中有趣的元素是我們的中小型地區和醫院。他們沒有看到下降幅度那麼大，因為他們隨後可能會對該患者進行治療，並且不會將該患者轉診至更大的中心。

If we track on shock and you look at the year, 6 out of the 12 months had positive growth. 8 of the 12 months had flat to positive. And 2 -- the first 2 months of COVID last April, May were down and they were down double digit. But after that, shock itself recovered, and that's kind of part of the playbook. And then in this hub and spoke, last piece of this, is, as we've mentioned, we set records in Q4. But in March, we set our records for most patients ever, most high-risk PCI patients ever and most cardiogenic shock patients ever. So we think the playbook works, and we like this hub-and-spoke network, and we like the changes we've made to the distribution to really capitalize on that opportunity.

如果我們追蹤衝擊並回顧這一年，就會發現 12 個月中有 6 個月實現了正成長。 12 個月中有 8 個月持平轉為正值。 2、去年 4 月和 5 月新冠疫情的前 2 個月出現了下降，而且下降了兩位數。但在那之後，震驚本身就恢復了，這就是劇本的一部分。然後，在這個中心和輻射中，最後一點是，正如我們所提到的，我們在第四季度創造了記錄。但在 3 月份，我們創下了有史以來最多患者、最多高風險 PCI 患者和最多心因性休克患者的紀錄。所以我們認為這個劇本是有效的，我們喜歡這個中心輻射型網絡，我們喜歡我們對發行版所做的改變，以真正利用這個機會。

Our next question comes from the line of Matthew O'Brien with Piper Sandler.

我們的下一個問題來自馬修·奧布萊恩和派珀·桑德勒的對話。

Just a couple of questions on kind of some products that I think are helping the business right now. One of them is clearly helping the business versus just the guidance, which is good to see getting back up to low double digits here, which I think is kind of what you're targeting for the business going forward or maybe a little bit faster. But for starters on the sheath side of things and I know this is kind of getting down to the weeds a little bit, Mike or Todd. But what are you seeing as far as utilization of the 2.5 sheaths among centers that have access to it? And then what's the timing on CP? Is it still kind of expected here in a few months? Because what I'm really trying to get at is, is this starting to accelerate some adoption of Impella because of access of the sheath and then CP can hopefully help accelerate things a little bit more?

只是關於我認為目前正在幫助業務的某些產品的幾個問題。其中之一顯然是幫助業務而不是僅僅提供指導，很高興看到這裡回到低兩位數，我認為這就是您未來業務發展的目標，或者可能更快一點。但對於剛開始接觸事物的表面的人來說，我知道這有點深入到雜草中，麥克或託德。但是，就可以使用 2.5 護套的中心而言，您對使用情況有何看法？那麼CP的時間安排是怎麼樣的呢？幾個月後這裡仍然有預期嗎？因為我真正想要了解的是，這是否會因為護套的使用而開始加速 Impella 的採用，然後 CP 有望幫助加速這一進程？

Thanks, Matt, for the question. So the short answer is the XR Sheath is the priority for CP. We do have it on the 2.5, and we did do cases in the U.S. last quarter. But the majority of our larger volume users are very comfortable with access closure today. PROTECT III showed we have low single-digit vascular complications and bleeding. We also showed that in the STEMI DTU FDA study. The single access is now approved also in Europe and has been the means of choice by a lot of the physicians that do the most Impellas. And so they'd much prefer today to have the CP.

謝謝馬特提出的問題。所以簡短的回答是 XR 護套是 CP 的優先選擇。我們確實在 2.5 上有它，上個季度我們確實在美國做了案例。但我們的大多數大容量用戶對今天的訪問關閉感到非常滿意。 PROTECT III 顯示我們的血管併發症和出血率較低。我們也在 STEMI DTU FDA 研究中證明了這一點。單一通道現已在歐洲獲得批准，並已成為許多進行最多 Impella 手術的醫生的選擇方式。所以他們今天更希望有這對CP。

They're comfortable with access closure and they like single access. So what we're doing with CP is you have the XR Sheath, which is a 510(k), but we are also in coordination with that. We're making some minor adjustments to the product to augment that, but that will require a PMA submission supplement. So that's where we think we're going to have the 2 aligned by the end of this fiscal year. But we're also pretty confident that part of the momentum we're seeing is just that the new techniques, the new clinical data and the single access really are the preference of our top centers.

他們對關閉通道感到滿意，並且喜歡單一通道。因此，我們對 CP 所做的就是 XR 護套，即 510(k)，但我們也在與之協調。我們正在對產品進行一些細微調整以增強這一點，但這需要 PMA 提交補充。因此，我們認為到本財年末我們將實現兩者的一致性。但我們也非常有信心，我們看到的部分動力只是新技術、新臨床數據和單一訪問確實是我們頂級中心的偏好。

Okay. Makes sense. And then shifting over to 5.5, which is clearly a nice tailwind or a meaningful tailwind right now. Mike, it seems like there was an acceleration in the number of centers using the products or getting access to the product here in fiscal Q4. Are those 211 sites entirely sites that were using 5.0 before? And then among the sites -- and again, I know we're getting down into the weeds. But are you seeing some of the sites that were 5.5 as available, more clinicians coming over and starting to use Abiomed for other procedures, now that they can see 5.5, see how well it works and how unique it is? And then saying, okay, maybe I can use CP in some other patients as well. So are we getting any signs of kind of some growing momentum because of 5.5 throughout an entire center?

好的。說得通。然後轉向 5.5，這顯然是一個很好的順風或一個有意義的順風。麥克，第四財季使用這些產品或造訪該產品的中心數量似乎有所增加。那211個網站都是以前使用5.0的網站嗎？然後在這些網站中——我知道我們正在陷入困境。但是您是否看到一些可用 5.5 的網站，更多的臨床醫生過來並開始使用 Abiomed 進行其他程序，現在他們可以看到 5.5，看看它的效果如何以及它有多麼獨特？然後說，好吧，也許我也可以對其他一些患者使用 CP。那麼，由於整個中心的 5.5，我們是否有任何成長動力的跡象？

Matt, the answer is yes, but it's -- remember, you have 2 different customer bases. You have the heart surgeons and then you have the interventional cardiologists. And they work together well in certain cases. They work together well in TAVR because they're all aligned in the hybrid lab. But there's still this inherent competition between high-risk PCI and CABG. And what we've shown is that the 2 work together, something we call high-risk revascularization. So as we identify these patients, some of these patients go for high-risk PCI, some of these patients go for high-risk CABG, where they utilize Impella and that was presented by Dr. Ed Soltesz from Cleveland Clinic on the approach that they use. And some of those CABG patients, they do have for kidney function and they need support coming off the heart lung machine.

馬特，答案是肯定的，但記住，你有兩個不同的客戶群。有心臟外科醫生，然後有介入心臟科醫生。並且在某些情況下它們可以很好地協同工作。它們在 TAVR 中協同工作良好，因為它們在混合實驗室中都保持一致。但高風險 PCI 和 CABG 之間仍存在固有的競爭。我們已經證明兩者是協同作用的，我們稱之為高風險血管重建。因此，當我們識別這些患者時，其中一些患者接受高風險 PCI，其中一些患者接受高風險 CABG，他們使用 Impella，克利夫蘭診所的 Ed Soltesz 博士介紹了他們使用的方法。其中一些冠狀動脈繞道手術患者確實有腎功能，他們需要心肺機的支持。

And this presentation is also still up. But what their protocol is, is if there's acute on chronic patient, they go to the Impella 5.5 as the primary driver. They no longer use the 5.0. And the 5.5 has the optical sensor. It gives us the ability to see what's happening and the pressure in the left ventricle. It's ideal for weaning. Then they establish that patient, then they decide is the revascularization going to be done in the cath lab, by the intervention cardiologists, are they going to do it in the surgical suite with CABG. In certain cases, if they need a VT ablation, they'll take them to the EP lab, and they'll do a VT ablation but the Impella pump is stabilizing that acute on chronic patient.

而且這個示範也還在進行中。但他們的方案是，如果慢性病患者出現急性症狀，他們會選擇 Impella 5.5 作為主要驅動器。他們不再使用5.0。 5.5有光學感測器。它使我們能夠看到正在發生的情況以及左心室的壓力。它非常適合斷奶。然後他們確定該患者，然後決定是由介入性心臟科醫師在導管室進行血管重建，或是在手術室進行冠狀動脈繞道術（CABG）。在某些情況下，如果他們需要 VT 消融，他們會帶他們去 EP 實驗室，他們會進行 VT 消融，但 Impella 幫浦可以穩定慢性患者的急性症狀。

That's a different patient than an AMI shock patient, whose first symptom is the heart attack that leads to shock. That patient is still going quickly into the cath lab through the door to balloon time protocol, where they'll put the Impella in before they do the PCI. So the short answer is yes, because it's driving the science and the recognition of unloading. And it allows us to take patients and make sure that we maintain the ability to still provide a path of the least invasive, most cost-effective approach to not only keep the patient alive, but send them home with their own heart.

這與 AMI 休克患者不同，後者的第一個症狀是心臟病發作並導致休克。該患者仍透過球囊時間協議快速進入導管室，在進行 PCI 之前將 Impella 放入其中。所以簡短的答案是肯定的，因為它正在推動科學和對卸載的認識。它使我們能夠接收患者，並確保我們仍然有能力提供一條侵入性最小、最具成本效益的方法，不僅讓患者活著，而且讓他們帶著自己的心回家。

And so we're really excited to see the leadership by Cleveland Clinic on surgery, Cedars out in LA, the teams in Chicago, across the board. The 5.5 is really a revolutionary product for heart failure. And we've added some heart failure people in the company and on the distribution. So we really are changing heart failure now to heart recovery, and it's a different mindset, but it's what 5.5 enables and what Impella BTR will continue because now we'll have the ability to send the patient home and have a pump that runs even longer without a purge.

因此，我們非常高興看到克利夫蘭診所在手術方面的領導力、洛杉磯的 Cedars 以及芝加哥的團隊的全面領導力。 5.5確實是心臟衰竭的革命性產品。我們在公司和分銷中增加了一些心臟衰竭人員。因此，我們現在確實正在將心臟衰竭轉變為心臟恢復，這是一種不同的思維方式，但這就是5.5 所實現的，也是Impella BTR 將繼續的，因為現在我們將有能力將患者送回家，並擁有運行時間更長的泵無需清除。

Our next question comes from the line of Jayson Bedford with Raymond James.

我們的下一個問題來自傑森貝德福德和雷蒙詹姆斯的對話。

Just a couple quick ones. I realize we're at the top of the hour. Just on 5.5. So if 5.5 and 5.0 is 15% of U.S. revenue, what percent is 5.5 these days?

只是幾個快速的。我意識到我們正處於最高峰。剛剛5.5。那麼，如果 5.5 和 5.0 占美國收入的 15%，那麼現在 5.5 佔百分之多少呢？

I don't have the actual percentage in front of me. It's -- the majority of the business now is 5.5. I would say it's close to -- it's over -- it's probably over 75%, Jayson.

我面前沒有實際的百分比。現在大部分業務都是 5.5。我想說，這已經接近——結束了——可能超過 75%，傑森。

Okay. And then on the guide, just wondering if you could talk about the expected growth in the U.S., which obviously has a much easier comp versus international for fiscal '22?

好的。然後在指南中，我想知道您是否可以談談美國的預期成長，因為美國 22 財年的經濟成長顯然比國際經濟要容易得多？

I think when you look at it across all 3 regions, we do expect to see double-digit growth. Obviously, rest of the world -- OUS is going to be growing a little bit faster with Japan and Germany. But even in the United States, whether you look at the low, medium and high-end of our range, we do expect to see nice growth, double-digit, mid-teens growth in the U.S. A lot of it obviously driven by the surgical business. So I think, overall, it's pretty evenly distributed across all 3 regions.

我認為，當你縱觀所有三個地區時，我們確實預計會出現兩位數的增長。顯然，世界其他地區——OUS 的成長速度將比日本和德國快一些。但即使在美國，無論你看我們的低端、中端還是高端產品，我們確實預計美國會出現兩位數、十幾歲左右的良好增長。其中很大一部分顯然是由外科業務。所以我認為，總體而言，它在所有 3 個地區的分佈相當均勻。

Okay. That's helpful. And just quickly, Mike, where are we with RECOVER IV in terms of starting that trial?

好的。這很有幫助。麥克，請快速告訴我們 RECOVER IV 的試驗進展如何？

We've got Executive Committee, Jayson. We're working through some of the specific details of it. It's a very difficult population to randomize, as you know, we've tried in the past. We think we can satisfy that now. We're looking at some things around consent. And yesterday, we presented the final summation of the 406 patients in the NCSI with a 71% survival. But what's really interesting in the presentation is that the status C, which is the kind of the classic shock patients had a 77% survival. We even have very, very positive survival on the Class C, which is the cardiac arrest group.

我們有執行委員會，傑森。我們正在研究其中的一些具體細節。如您所知，我們過去曾嘗試過對這一群體進行隨機化，這是非常困難的。我們認為我們現在可以滿足這一點。我們正在研究一些有關同意的事情。昨天，我們公佈了 NCSI 中 406 名患者的最終總和，存活率為 71%。但演示中真正有趣的是，C 狀態（即典型的休克患者）的存活率為 77%。我們甚至在 C 級（心臟驟停組）中也有非常非常積極的生存率。

So we're -- we have a tremendous amount of information. We're now working through the logistical challenges and how we'll do the consent. We expect to finish the design end of the year and start this study the following year. But it really is a difficult population, but we feel very confident now with the best practices in Japan, in Italy and Germany and the U.S., that we have the formula for the higher survival with more than 90% having native heart recovery for this type of patient.

所以我們——我們擁有大量資訊。我們現在正在解決後勤方面的挑戰以及如何獲得同意。我們預計在今年年底完成設計，並於隔年開始這項研究。但這確實是一個困難的人群，但我們現在對日本、義大利、德國和美國的最佳實踐非常有信心，我們擁有更高生存率的公式，超過 90% 的此類患者俱有原生心臟恢復的病人。

Our next question comes from the line of Marie Thibault with BTIG.

我們的下一個問題來自 Marie Thibault 與 BTIG 的關係。

Just a quick 1 here to follow-up on the comments you made to Jayson. I wanted to confirm. We always like to see that U.S. patient metric, and I know you gave that to us this quarter, up 13% year-over-year. Is high teens the right bar to think about if we think about the midpoint of your guidance for fiscal '22?

在此快速跟進您對傑森發表的評論。我想確認一下。我們總是希望看到美國患者指標，我知道您本季向我們提供了該指標，年增 13%。如果我們考慮你們 22 財政年度指導的中點，那麼高青少年是否是正確的標準？

Are you talking from a U.S. perspective utilization?

您是從美國的角度談利用率嗎？

Yes. U.S. patient. Yes, exactly.

是的。美國病人。對，就是這樣。

I would say patient utilization would be somewhere in that mid teens. I think it makes sense based on our guidance.

我想說，患者利用率將在十幾歲左右。我認為根據我們的指導這是有道理的。

Yes. I back into that. I just wanted to confirm, given some of the higher ASPs and benefit you've been seeing there. Okay. And then a quick follow-up here. I don't think we've heard too much on Breethe, but it seems to be getting very good feedback. I would love to hear whether you've included any of that revenue in fiscal '22, whether that's something we can see as a meaningful contributor this year?

是的。我回到那個。我只是想確認一下，考慮到您在那裡看到的一些更高的平均售價和好處。好的。然後在這裡進行快速跟進。我認為我們對 Breethe 的了解不多，但似乎得到了很好的回饋。我很想知道您是否已將這些收入納入 22 財年，這是否是我們今年可以視為有意義的貢獻者？

Yes. Thanks, Marie. Good question. I think in terms of meaningful impact, it's been a great launch. We had 5 sites right now, treated over -- about 20 patients. I think as you think about fiscal year '22, it will be somewhat of that controlled rollout that we've talked about. So again, focus on training and education and, more importantly, patient outcomes. So we'll continue to do a controlled rollout. And from a revenue perspective, I'd say it's not going to probably have a material impact on us as we think about it, the big picture, probably more of a fiscal year '23 story.

是的。謝謝，瑪麗。好問題。我認為就有意義的影響而言，這是一次偉大的發布。我們現在有 5 個站點，治療了大約 20 名患者。我認為，當您考慮 22 財年時，這將在某種程度上是我們討論過的受控部署。因此，再次強調訓練和教育，更重要的是病人的治療效果。因此，我們將繼續進行受控的推出。從收入的角度來看，我想說這可能不會對我們產生實質影響，因為我們考慮的是大局，可能更多的是 23 財年的故事。

Our next question comes from the line of Cecilia Furlong with Morgan Stanley.

我們的下一個問題來自塞西莉亞·弗隆與摩根士丹利的對話。

This is Calvin on for Cecilia. Just 2 quick ones for me. The first is just could you share with us your thoughts on what your M&A strategy for FY '22 is going to be? Do you anticipate remaining kind of active on that front in '22 and beyond? And the second is just -- could you give us an update on STEMI DTU, on kind of what the pace of enrollment has been on -- perhaps on full enrollment timing to the extent you can share?

這是卡爾文為西西莉亞配音的節目。對我來說只有 2 個快速的。首先，您能否與我們分享您對 22 財年併購策略的看法？您預計 22 年及以後在這方面仍然保持活躍嗎？第二個問題是——您能否向我們介紹 STEMI DTU 的最新情況，以及招生進度——也許您可以分享一下全面招生的時間表？

I'll take the first question with regard to M&A. Obviously, if you look at our cash deployment strategy, I think our top priority remains investment in organic growth opportunities that we believe lay the groundwork for sustainable growth. With that said, we'll continue to look at new technologies and core competencies. As of the last quarter, we still have a little over $100 million investment on our balance sheet in roughly 15 to 18 companies. And we'll, again, continue to look for differentiated technologies that can either increase Impella utilization, improve patient outcomes, anything around access, closure and monitoring. But ultimately, we're looking for technology that can bring additional value to our patients, whether in the cath lab, ICU or CCU.

我回答第一個問題，關於併購。顯然，如果你看看我們的現金部署策略，我認為我們的首要任務仍然是對有機成長機會的投資，我們相信這些機會為永續成長奠定了基礎。話雖如此，我們將繼續專注於新技術和核心能力。截至上季度，我們的資產負債表上仍有約 15 至 18 家公司的投資略高於 1 億美元。我們將再次繼續尋找差異化技術，以提高 Impella 的利用率，改善患者的治療效果，以及任何有關訪問、關閉和監控的方面。但最終，我們正在尋找能夠為我們的患者帶來額外價值的技術，無論是在導管實驗室、ICU 還是 CCU。

Calvin, on the STEMI DTU, we added 6 sites in Q4, and we enrolled 28 patients in Q4. So we're now at 61 patients enrolled in 26 hospitals.

Calvin，在 STEMI DTU 上，我們在第四季度增加了 6 個站點，並在第四季度招募了 28 名患者。現在我們有 26 家醫院的 61 位病患入組。

Our next question comes from the line of Danielle Antalffy with SVB Leerink.

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

I actually just have 1 question, and it's tied to longer-term growth. So I appreciate your giving fiscal 2022 guidance today. I know you're not going to give us fiscal '23 guidance today. But at a high level, if you could comment qualitatively. Fiscal 2022 is still facing some odd comps with COVID and the recovery and things like that. So I guess, as we look longer term, what's the right way to think about the underlying growth profile of the company? Should we be thinking about it in line with sort of end cardiogenic shock and high-risk PCI volume? Or between now and, say, this time next year, do you feel like you guys are making progress among some of the sort of -- I don't know if it's too dramatic to call them deniers or the folks that were impacted by the AHA data that we should see underlying growth acceleration? I know that's really difficult to answer, but even any qualitative comments would be helpful.

實際上我只有一個問題，它與長期成長有關。因此，我感謝您今天提供的 2022 財政年度指導。我知道您今天不會向我們提供 23 財年的指導。但在高水準上，如果你能進行定性評論的話。 2022 財年仍面臨一些奇怪的情況，包括新冠疫情和經濟復甦等。所以我想，當我們著眼長遠時，思考公司潛在成長狀況的正確方法是什麼？我們是否應該根據心因性休克終末期和高風險 PCI 量來考慮它？或者從現在到明年這個時候，你們是否覺得你們在某些方面正在取得進展——我不知道稱他們為否認者或那些受到影響的人是否太戲劇化了。AHA 數據表明我們應該看到潛在的成長加速？我知道這確實很難回答，但即使是任何定性評論也會有所幫助。

Danielle, I would say at a high level, Abiomed 2.0 expects to be 1 of the fastest-growing profitable medical device companies, and we have been for the last 10 years. And we think between our existing products and new products, existing indications, new indications and potentially stronger guidelines in existing countries and new countries, we have a decade ahead of us of growth.

Danielle，我想說，從高水準來看，Abiomed 2.0 預計將成為成長最快的獲利醫療器材公司之一，過去 10 年我們一直如此。我們認為，在現有產品和新產品、現有適應症、新適應症以及現有國家和新國家可能更強的指導方針之間，我們還有十年的成長空間。

There are no further questions. I would now like to turn the call over to Mike Minogue for closing remarks.

沒有其他問題了。我現在想將電話轉給邁克·米洛 (Mike Minogue) 致閉幕詞。

Thanks, everyone, for the time today. Sorry, it went over. If there's any follow-up questions, please feel free to reach out to us. Have a great day.

謝謝大家今天抽出時間。抱歉，事情過去了。如果有任何後續問題，請隨時與我們聯繫。祝你有美好的一天。

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。