ABIOMED Inc (ABMD) 2021 Q2 法說會逐字稿

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

女士們先生們，感謝你們的支持，並歡迎參加 Abiomed 2021 年第二季財報電話會議。 （操作員指示）請注意，今天的會議可能會被錄音。 （操作員說明）

I would now like to hand the conference over to your speaker today, Mr. Todd Trapp. Sir, you may begin.

現在我想將會議交給今天的演講者托德·特拉普先生。先生，您可以開始了。

Good morning, and welcome to Abiomed's Second Quarter Fiscal 2021 Earnings 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.

早安，歡迎參加 Abiomed 的 2021 財年第二季財報電話會議。我是副總裁兼財務長 Todd Trapp，我和 Abiomed 董事長、總裁兼執行長 Mike Minogue 在一起。

The format for today's call will be as follows. First, Mike will discuss second 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.

今天電話會議的格式如下。首先，麥克將討論第二季的業務和營運亮點，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'd 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 and 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 obligation 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風險和不確定性，並且不能保證未來。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 our call over to Abiomed's Chairman, President and Chief Executive Officer, Mike Minogue.

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

Thanks, Todd, and good morning, everyone. Over the past 7 months, we've navigated the challenges presented to our patients, customers and employees by COVID-19 and coronary heart disease. Our ability to put patients first and adapt and execute as an organization has been our strength.

謝謝托德，大家早安。在過去 7 個月裡，我們應對了 COVID-19 和冠心病對患者、客戶和員工帶來的挑戰。我們將患者放在第一位以及作為一個組織進行調整和執行的能力一直是我們的優勢。

We have created the new Abiomed 2.0 operating procedures, while significantly investing in innovation and clinical research to revolutionize the standard of care for hemodynamic support. I am proud of the patients for this commitment, and leadership from our employees and customers to recover hearts and save lives every day.

我們創建了新的 Abiomed 2.0 操作程序，同時大力投資於創新和臨床研究，以徹底改變血流動力學支持的護理標準。我為患者的這項承諾以及我們的員工和客戶每天在恢復心臟和拯救生命方面的領導感到自豪。

For fiscal '21, we designated a three phase red, yellow, green approach to address the evolving COVID-19 environment. Q1 was the red phase, reflecting the broad restrictions on elective cases, limited access to hospitals and limitations on travel, meetings and headquarters operations.

對於 21 財年，我們指定了紅、黃、綠三階段方法來應對不斷變化的 COVID-19 環境。第一季是紅色階段，反映了對選擇性病例的廣泛限制、前往醫院的限制以及旅行、會議和總部運營的限制。

In our Q2, we moved to the yellow phase with the acceleration of Abiomed 2.0 and preparing to return to growth during our summer quarter with essential procedures. We were focused on sequential and year-over-year growth, which occurred in hospitals and geographies better positioned to handle the resurgence of COVID-19 patients.

在第二季度，隨著 Abiomed 2.0 的加速，我們進入了黃色階段，並準備好透過必要的程序在夏季恢復成長。我們重點關注連續增長和同比增長，這種增長發生在能夠更好地應對 COVID-19 患者復甦的醫院和地區。

However, 2 elements remain challenging in Q2. First, patient anxiety caused delays in seeking treatment for urgent and emergent care. Second, hospital ICU availability impacted patient referrals, further causing delays in cardiovascular treatment for patients without coronavirus. These factors keep patients' home longer, suppress the referral network and simultaneously increase patient risk and cardiogenic shock and right. This phenomenon has been reported for high-risk PCI, STEMI and Cardiogenic Shock.

然而，第二季有兩個因素仍然具有挑戰性。首先，患者焦慮導致尋求緊急護理的延誤。其次，醫院 ICU 的可用性影響了患者的轉診，進一步導致沒有冠狀病毒的患者的心血管治療延遲。這些因素使患者在家中停留的時間更長，抑制了轉診網絡，同時增加了患者發生心臟休克的風險。這種現像在高風險 PCI、STEMI 和心因性休克中已有報告。

However, in this COVID environment, staging PCI and high-risk open heart surgery called CABG, are less preferential. And the heart failure patient populations at the hospital tend to be higher risk and sicker. As a result, in our Q2 yellow phase, we have pockets of sustainable growth and recovery across the U.S., Europe and Japan.

然而，在這種新冠肺炎環境下，分期 PCI 和稱為 CABG 的高風險心臟直視手術就不太受青睞。醫院裡的心臟衰竭患者往往風險更高、病情更嚴重。因此，在第二季的黃色階段，我們在美國、歐洲和日本實現了永續成長和復甦。

In Q2, Abiomed delivered $210 million in revenue, up 27% sequentially over Q1 and up 2% year-over-year. During the quarter, patient utilization increased each month, led by recovery in high-risk PCI essential procedures and positive growth in cardiogenic shock. We believe that this trend will continue, but we do not expect a perfectly linear upswing, given the volatility with COVID resurgence.

第二季度，Abiomed 營收 2.1 億美元，比第一季季增 27%，年增 2%。本季度，由於高風險 PCI 基本手術的恢復和心因性休克的積極增長，患者利用率逐月增加。我們相信這一趨勢將持續下去，但考慮到新冠疫情捲土重來的波動性，我們預計不會出現完美的線性上升。

Outside of the U.S., revenue increased 25% sequentially and increased 14% year-over-year as we saw strong recovery within the quarter in both Europe and Japan. Despite the crisis in Q2, we remained operationally disciplined and focused on our fiscal '21 goals and tactical plan. We delivered 29% operating margin while continuing to invest in research and innovation at record levels for the company. Our balance sheet remains robust with $736 million in cash and 0 debt, and we continue to expand our lead with one of the strongest patent portfolios in Medtech, with 929 Impella patents and 835 patents pending.

美國以外地區的營收季增 25%，年增 14%，因為我們看到歐洲和日本在本季度出現強勁復甦。儘管第二季發生了危機，我們仍然保持營運紀律，並專注於我們的 21 財年目標和戰術計劃。我們實現了 29% 的營業利潤率，同時繼續以公司創紀錄的水平投資於研究和創新。我們的資產負債表保持強勁，擁有7.36 億美元現金和0 債務，我們憑藉醫療技術領域最強大的專利組合之一（擁有929 項Impella 專利和835 項正在申請的專利）繼續擴大我們的領先地位。

Overall, I am proud to report that we achieved our Q2 yellow phase goals and grew sequentially, stabilized revenue in the U.S. and increased revenue double digits outside of the U.S. while advancing our regulatory, clinical and engineering milestones.

總的來說，我很自豪地報告，我們實現了第二季度的黃色階段目標，並實現了連續增長，穩定了美國的收入，並在美國以外的地區實現了兩位數的收入增長，同時推進了我們的監管、臨床和工程里程碑。

For today's call, I will provide 3 updates: first, on our planned transition to the green phase; second, the new Impella clinical data; and third, our progress on new technology milestones. So first, operationally, we achieved our Q2 yellow phase goals. We also ramped manufacturing back-up to full production in Danvers, Massachusetts and Aachen, Germany. And we continue to expand training and education online with over 1,000 physicians trained in the quarter with virtual calls and leveraging protectedpci.com and CAMP PCI weekly live and tele supported cases.

在今天的電話會議中，我將提供 3 條最新消息：第一，我們計劃向綠色階段過渡；二、新Impella的臨床數據；第三，我們在新技術里程碑方面的進展。首先，在營運上，我們實現了第二季黃色階段的目標。我們也加強了馬薩諸塞州丹佛斯和德國亞琛的製造支持，以實現全面生產。我們繼續擴大線上培訓和教育，本季有 1,000 多名醫生透過虛擬電話並利用 protectedpci.com 和 CAMP PCI 每週現場和電話支援案例接受了培訓。

We are preparing for our transition to the green phase by the end of the third quarter despite the resurgence of COVID-19. This transition to green means we're playing offense versus defense, utilizing hospital protocols to improve outcomes and grow Impella and ECPELLA adoption.

儘管 COVID-19 捲土重來，我們仍準備在第三季末過渡到綠色階段。向綠色的轉變意味著我們正在攻守結合，利用醫院協議來改善結果並提高 Impella 和 ECPELLA 的採用率。

Internally, we are now routinely screening and testing employees for COVID in our manufacturing facilities in Danvers and Aachen. This enabled Abiomed to invest in innovation, achieve our time lines and treat a record number of patients in heart failure, including those with coronavirus. Abiomed 2.0 allows us to adapt our execution on training, data and time with the objectives to minimize patient anxiety and maximize the referral network with Protected PCI, cardiogenic shock protocols and FDA emergency youth authorizations for COVID treatment.

在內部，我們現在正在丹佛斯和亞琛的製造工廠定期對員工進行新冠病毒篩檢和檢測。這使得 Abiomed 能夠投資於創新，實現我們的時間表，並治療創紀錄數量的心臟衰竭患者，包括感染冠狀病毒的患者。 Abiomed 2.0 使我們能夠調整訓練、數據和時間的執行，目標是透過受保護的 PCI、心因性休克協議和 FDA 緊急青少年授權來最大程度地減少患者焦慮並最大化轉診網絡。

Transitioning to my second update, 2 weeks ago, we presented the most robust clinical data at TCT in company history. Impella was highlighted with 3 prospective FDA post-approval studies and more than 20 presentations and abstracts, including our newest PROTECT III data presented from the TCT Connect main stage and the first look of the RESTORE EF Study, which demonstrates a clear improvement in ejection fraction and patient quality of life as a result of the Impella supported Protected PCI.

兩週前，我們在 TCT 上展示了公司歷史上最可靠的臨床數據。 Impella 因3 項前瞻性FDA 批准後研究以及20 多項簡報和摘要而受到關注，其中包括TCT Connect 主階段提供的最新PROTECT III 數據以及RESTORE EF 研究的第一眼，該研究表明射血分數有明顯改善Impella 支援的受保護 PCI 提高了患者的生活品質。

The benefit of ejection fraction improvement with Impella Protected PCI is no longer debatable. And these clinical endpoints are validated in multiple prospective studies as compared to the in-and-out PCI treatment technique. The PROTECT III study also demonstrates even lower Impella rates of vascular complications, bleeding and stroke at 1%, 1.8% and 0.4%, respectively, compared to Impella 2.5 in the PROTECT II study.

Impella Protected PCI 改善射血分數的好處已不再有爭議。與進出 PCI 治療技術相比，這些臨床終點在多項前瞻性研究中得到了驗證。 PROTECT III 研究還表明，與 PROTECT II 研究中的 Impella 2.5 相比，Impella 的血管併發症、出血和中風發生率甚至更低，分別為 1%、1.8% 和 0.4%。

To note, the intra-aortic balloon pump stroke rate was statistically higher than Impella in PROTECT II at 30 days. And the intra-aortic balloon pump is now deemed in the United States Class III or harmful for post-cardiotomy cardiogenic shock.

值得注意的是，PROTECT II 中 30 天時主動脈內球囊幫浦衝程率在統計上高於 Impella。主動脈內球囊反搏器目前在美國被視為 III 級或對心臟切開術後心因性休克有害。

As a reminder, we hosted a TCT recap call with Q&A led by our Chief Medical Officer last week, and the link to this webcast can be found on our investor website. Impella is the most studied heart pump in the history of the FDA with 14 years of studies originating in 2006 and continuing to today. Impella has over 780 clinical publications, 7 completed FDA studies and 5 post-market studies completed or ongoing, validating Impella exclusively as safe and effective for Protected PCI, cardiogenic shock and right heart failure. Impella also received FDA emergency use authorizations for ECPELLA and Impella RP for COVID-related complications. We will continue to study and publish best practice protocols as we pursue Class I guideline recommendations with STEMI DTU, PROTECT IV and RECOVER IV studies.

謹此提醒，我們上週舉辦了由首席醫療官主持的 TCT 回顧電話會議，並進行了問答，該網絡廣播的鏈接可以在我們的投資者網站上找到。 Impella 是 FDA 歷史上研究最多的心臟泵，從 2006 年開始一直持續到今天，已有 14 年的研究。 Impella 擁有超過780 篇臨床出版物、7 項已完成的FDA 研究以及5 項已完成或正在進行的上市後研究，驗證了Impella 對於受保護的PCI、心源性休克和右心衰竭的安全性和有效性。 Impella 也獲得了 FDA 緊急使用 ECPELLA 和 Impella RP 治療新冠相關併發症的授權。我們將繼續研究和發布最佳實踐方案，透過 STEMI DTU、PROTECT IV 和 RECOVER IV 研究尋求 I 類指南建議。

We are currently enrolling our STEMI DTU study and plan to initiate our PROTECT IV study with a goal for our first patient treated at the end of this fiscal year or Q1 of FY '22.

我們目前正在報名 STEMI DTU 研究，並計劃啟動 PROTECT IV 研究，目標是在本財政年度結束或 22 財年第一季治療第一位患者。

Now I would like to share a recent patient story, highlighting the exclusive benefit of the Impella RP to percutaneously treat right heart failure. Andrea Fedder, a 57-year old retired teacher was visiting her daughter and son-in-law and her 2-day old grandson, when she began experiencing dizziness and other concerning symptoms. Her symptoms returned the next day, followed by convulsions. Despite the pandemic, Andrea was rushed by ambulance to Palm Beach Gardens Medical Center in Florida, where Dr. Nishant Patel diagnosed right ventricle heart failure with a life-threatening clot. He inserted the Impella RP heart pump percutaneously to allow her heart to rest and administered a drug to dissolve the clot. After 3 days of support, the Impella RP was weaned and explanted. Andrea was discharged to home a week later with normal ejection fraction for her right ventricle. Today, Andrea is grateful for quality time with her family, and she's especially grateful to hold her grandson.

現在我想分享一個最近的病患故事，強調 Impella RP 經皮治療右心衰竭的獨特優勢。 57 歲的退休教師安德里亞·費德 (Andrea Fedder) 正在探望她的女兒、女婿以及剛出生 2 天的孫子，這時她開始出現頭暈和其他令人擔憂的症狀。第二天，她的症狀再次出現，隨後出現抽搐。儘管發生了大流行，安德里亞還是被救護車送往佛羅裡達州棕櫚灘花園醫療中心，尼尚特·帕特爾醫生在那裡診斷出右心室心臟衰竭並伴隨危及生命的血栓。他經皮插入 Impella RP 心臟泵，讓她的心臟休息，並注射藥物溶解血栓。經過 3 天的支持後，Impella RP 斷奶並移出。一週後，安德里亞出院回家，右心室射血分數正常。今天，安德里亞（Andrea）很感激與家人共度的美好時光，她特別感激能抱著她的孫子。

Moving on to our third update on product pipeline. We continue to make our products smaller, smarter and more connected. The Impella 5.5 with SmartAssist is now at 121 U.S. sites, driving a 53% year-over-year increase in revenue for surgical heart pumps. This forward flow heart pump is smaller than the 5.0, easier to implant via the axillary artery and avoid the sternonomy and coring of the left ventricle to provide full hemodynamic support with smart algorithms designed for management, weaning and identification of right heart failure.

繼續我們關於產品管道的第三次更新。我們不斷讓我們的產品變得更小、更聰明、連結性更強。配備 SmartAssist 的 Impella 5.5 目前已在美國 121 個站點使用，推動手術心臟幫浦收入年增 53%。這款前向流心臟幫浦比5.0 更小，更容易透過腋動脈植入，避免了左心室的胸骨切開術和取心術，透過專為管理、離線和識別右心衰竭而設計的智慧演算法提供全面的血流動力學支持。

We also continue to receive positive feedback on the blood compatibility with the most positive testing data on record for beds. This game-changing device is designed for heart surgeon and answers the clinical need.

我們也持續收到有關血液相容性的正面回饋，以及有記錄的床位最積極的測試數據。這款改變遊戲規則的設備專為心臟外科醫生設計，可滿足臨床需求。

Our exclusive Impella Connect capability is now live at 477 U.S. sites, more than doubling the number of accounts compared to last quarter. Additionally, nearly half of our U.S. patients are now monitored in the cloud with Impella Connect. We have an additional 484 sites with the hardware already on the console, requiring only hospital WiFi permission to activate the Impella Connect account.

我們獨特的 Impella Connect 功能現已在 477 個美國站點上線，帳戶數量比上季增加了一倍多。此外，我們近一半的美國患者現在透過 Impella Connect 在雲端進行監測。我們還有另外 484 個站點的硬體已安裝在控制台上，僅需要醫院 WiFi 權限即可啟動 Impella Connect 帳戶。

Lastly, we submitted our 510(k) approval last quarter with the XR sheet with the Impella 2.5 and remain on track for a limited market release by the end of Q3. We are delivering ahead of schedule on key regulatory milestones. On October 26, we announced 510(k) clearance of the Abiomed's Breethe OXY-1 System and will initiate our controlled launch at our first 5 hospitals in Q3.

最後，我們上季度透過 Impella 2.5 的 XR 板材提交了 510(k) 批准，並預計在第三季末有限市場發布。我們正在提前實現關鍵的監管里程碑。 10 月 26 日，我們宣布 Abiomed 的 Breethe OXY-1 系統獲得 510(k) 批准，並將於第三季度在我們的前 5 家醫院啟動受控啟動。

We are very excited to add ECMO clinical capability of end organ oxygenation and combined therapy to include unloading with ECPELLA. During the COVID crisis, we have further studied the ECPELLA benefits and will expand our patient population to include respiratory therapy alone.

我們非常高興能夠增加 ECMO 終末器官氧合和聯合治療（包括 ECPELLA 卸載）的臨床能力。在新冠病毒危機期間，我們進一步研究了 ECPELLA 的益處，並將擴大我們的患者群體，將呼吸療法納入其中。

On October 28, we announced a successful first-in-man series of 2 patients in the U.S. FDA early feasibility study for Impella ECP, the world's smallest heart pump. The 2 procedures were successfully performed at Ascension St. John in Detroit and Christ Hospital in Cincinnati.

10 月 28 日，我們宣佈在美國 FDA 對世界上最小的心臟泵 Impella ECP 的早期可行性研究中成功進行了 2 名患者的首次人體試驗。這兩次手術均在底特律的阿森松聖約翰醫院和辛辛那提的基督醫院成功進行。

The Impella ECP, which stands for Expandable Cardiac Power is an innovative true 9 French access closure pump with CP-like flow. We believe this is a game changer for high-risk PCI.

Impella ECP 代表可擴展心臟動力，是一款創新型真正 9 French 通路閉合泵，具有類似 CP 的流量。我們相信這將改變高風險 PCI 的遊戲規則。

In conclusion, we executed during the yellow phase and are transitioning to the green phase in the second half of the fiscal year. COVID-19 patients present with heart, kidney and lung failure and the fear of COVID-19 keeps some patients with coronary heart disease at home causing them to be more high risk when they seek care. Hospitals are now better prepared to handle the resurgence of COVID-19 patients. And Abiomed 2.0 is in full swing with online everything, allowing support of our patients and physicians in the cloud and at the hospital bedside 24/7.

總之，我們在黃色階段執行，並在本財年下半年過渡到綠色階段。 COVID-19 患者出現心臟、腎臟和肺功能衰竭，對 COVID-19 的恐懼使一些患有冠心病的患者留在家中，導致他們在尋求治療時面臨更高的風險。醫院現在已做好更好的準備來應對 COVID-19 患者的復發。 Abiomed 2.0 正在全面展開，一切都在線，允許我們的患者和醫生在雲端和醫院床邊 24/7 獲得支援。

Our technology platform of Impella and ECMO provides unique solutions for heart muscle recovery and organ oxygenation for coronavirus, coronary heart disease and cardiogen shock patients. No other MedTech company has this innovative vision or core competency.

我們的Impella和ECMO技術平台為冠狀病毒、冠狀動脈心臟病和心因性休克患者的心肌恢復和器官氧合提供了獨特的解決方案。沒有其他醫療科技公司擁有這種創新願景或核心能力。

At Abiomed, we remain steadfast in achieving our fiscal '21 goals focused on innovation, improving clinical outcomes and growing revenue. We are playing offense with technology and clinical research, and we will emerge from COVID-19 as a stronger company, uniquely positioned to change the standard of care.

在 Abiomed，我們堅定不移地實現 21 財年目標，重點是創新、改善臨床結果和增加收入。我們正在利用技術和臨床研究進行攻勢，我們將從 COVID-19 中脫穎而出，成為一家更強大的公司，擁有獨特的優勢來改變護理標準。

We appreciate our shareholders for their continued support on this journey. I will end by thanking our customers and employees for their hard work and dedication to recovering hearts and saving lives.

我們感謝股東在過程中給予的持續支持。最後，我要感謝我們的客戶和員工為康復心臟和拯救生命所做的辛勤工作和奉獻。

I will now turn the call over to Todd Trapp, our CFO.

我現在將把電話轉給我們的財務長 Todd Trapp。

Thanks, Mike, and good morning, everyone. In the quarter, we delivered revenue of $210 million, an increase of 27% sequentially and an increase of 2% versus prior year. While our business continues to be negatively impacted by the COVID-19 pandemic, we saw a gradual improvement in patient utilization in our key geographies over the course of the quarter.

謝謝麥克，大家早安。本季度，我們營收 2.1 億美元，比上一季成長 27%，比去年同期成長 2%。儘管我們的業務繼續受到 COVID-19 大流行的負面影響，但我們看到本季主要地區的患者利用率逐漸改善。

By region, the U.S. reported revenue of $172 million, up 28% sequentially and flat versus prior year. U.S. patient utilization increased 24% sequentially and was down 4% year-over-year. Sequentially, high-risk PCI and AMI cardiogenic shock grew 33% and 20%, respectively. Versus prior year, cardiogenic shock increased 1%, while high-risk PCI declined 8%.

按地區劃分，美國報告收入為 1.72 億美元，環比增長 28%，與上年持平。美國患者利用率較上季成長 24%，年減 4%。隨後，高風險 PCI 和 AMI 心因性休克分別增加了 33% 和 20%。與去年相比，心因性休克增加了 1%，而高風險 PCI 減少了 8%。

As we discussed on our last call, we saw resurgence in COVID cases in July across some of our key markets, such as Texas, California and Florida, which impacted our utilization in that month. Within the quarter, we did see a recovery in some of these regions. And overall, we saw a sequential improvement in U.S. patients in August and September.

正如我們在上次電話會議中討論的那樣，我們看到 7 月份一些關鍵市場（例如德克薩斯州、加利福尼亞州和佛羅裡達州）的新冠病例再次出現，這影響了我們當月的利用率。在本季度內，我們確實看到其中一些地區出現復甦。總體而言，我們在 8 月和 9 月看到美國患者的病情連續改善。

In the U.S., at the end of September, the Impella 2.5 and CP have reached 1,468 sites. The Impella 5.0 has been placed in 657 sites. And the Impella 5.5 with SmartAssist is now in 121 sites, up 31 sites versus prior quarter. The full market release of the Impella 5.5 continues to deliver as our less-sided surgical portfolio, including the 5.0, TLD and the 5.5, reporting a 53% increase in revenue versus prior year. Finally, the Impella RP is in 552 sites, up 14 sites versus Q1, with RP revenue increasing 4% versus prior year.

在美國，截至9月底，Impella 2.5和CP已達到1,468個站點。 Impella 5.0 已部署在 657 個地點。配備 SmartAssist 的 Impella 5.5 目前已在 121 個站點中使用，比上一季增加了 31 個站點。 Impella 5.5 的全面市場發布繼續作為我們的次要手術產品組合（包括 5.0、TLD 和 5.5）交付，報告收入與去年相比增長了 53%。最後，Impella RP 已覆蓋 552 個站點，比第一季增加了 14 個站點，RP 收入比去年同期增加了 4%。

In the U.S., we continue to see favorable sales mix as we transition to Impella CP with SmartAssist and Impella 5.5 with SmartAssist. In the quarter, the reorder rate was 100%, a slight improvement over last quarter. Average combined inventory at the hospitals for the Impella 2.5 and CP was approximately 4.6 units per site, in line with the inventory levels we saw last quarter.

在美國，隨著我們轉向配備 SmartAssist 的 Impella CP 和配備 SmartAssist 的 Impella 5.5，我們繼續看到有利的銷售組合。本季度，再訂貨率為100%，較上季略有改善。醫院每個地點的 Impella 2.5 和 CP 平均合併庫存約為 4.6 台，與我們上季度看到的庫存水準一致。

Outside the U.S., revenue totaled $38 million, up 25% sequentially and up 14% year-over-year. Our European revenue increased 29% sequentially and 17% versus prior year, driven by a recovery in Germany, Switzerland and Italy and favorable foreign exchange. Specifically, German revenue was up 29% sequentially and up 17% versus prior year. The year-over-year performance in Germany was driven by higher patient utilization, favorable foreign exchange and timing of reorders. In Germany, both high-risk PCI and cardiogenic shock grew mid-single digits in the quarter.

美國以外地區的收入總計 3,800 萬美元，季增 25%，年增 14%。受德國、瑞士和義大利經濟復甦以及有利外匯的推動，我們的歐洲收入環比增長 29%，較上年增長 17%。具體而言，德國營收季增 29%，較前一年成長 17%。德國的年比表現是由較高的患者利用率、有利的外匯和再訂單時機所推動的。在德國，本季高風險 PCI 和心因性休克均出現中個位數成長。

In Japan, patient utilization was up 32% sequentially and up 29% year-over-year. In Q2, we delivered $10 million in revenue, up 15% sequentially and up 7% year-over-year, primarily driven by higher patient utilization, which was partially offset by lower site openings and console sales.

在日本，患者利用率較上季成長 32%，較去年同期成長 29%。第二季度，我們實現了 1000 萬美元的收入，環比增長 15%，同比增長 7%，這主要是由於患者利用率提高，但部分被較低的站點開放和控制台銷售所抵消。

As discussed on our last earnings call, we communicated lower site openings in the quarter versus prior year. We opened up 14 sites in the quarter and now are in 142 sites in Japan.

正如我們在上次財報電話會議上所討論的那樣，我們表示本季的網站空缺數量低於去年同期。我們在本季開設了 14 個站點，目前在日本已開設 142 個站點。

Moving to key financial metrics. Gross margin was 81.5% in the quarter compared to 83% in the prior year. The year-over-year variance was driven by sales mix and incremental costs to accelerate the Impella Connect rollout. One of our main objectives during the yellow phase was to continue to invest in innovation despite the short-term headwinds.

轉向關鍵財務指標。本季毛利率為 81.5%，去年同期為 83%。同比差異是由銷售組合和加速 Impella Connect 推出的增量成本所驅動的。我們在黃色階段的主要目標之一是儘管存在短期阻力，但仍繼續投資於創新。

In the second quarter, R&D expense totaled $31 million, an increase of 27% versus prior year. We continue to focus on breaking the small bore barrier with investments in the XR sheet, the 9 French ECP pump, and the Impella 5.5 with SmartAssist. We are also investing in clinical studies like STEMI DTU, PROTECT IV and RECOVER IV with the goal of achieving Class I recommendations in STEMI, high-risk PCI and AMI cardiogenic shock.

第二季研發費用總計3,100萬美元，較去年同期成長27%。我們繼續致力於透過投資 XR 板材、9 French ECP 泵浦和配備 SmartAssist 的 Impella 5.5 來打破小口徑障礙。我們也投資 STEMI DTU、PROTECT IV 和 RECOVER IV 等臨床研究，目標是在 STEMI、高風險 PCI 和 AMI 心因性休克方面達到 I 級建議。

SG&A expense for the second quarter totaled $79 million, down 8% versus prior year. We remain focused and disciplined on managing our discretionary costs and are also benefiting from lower expenses on COVID-impacted-related activities, including T&E and trade shows.

第二季的 SG&A 費用總計 7,900 萬美元，比去年同期下降 8%。我們仍然專注並嚴格管理可自由支配成本，並且還受益於受新冠疫情影響的相關活動（包括差旅及娛樂和貿易展）費用的降低。

In the quarter, operating income grew 2% to $161 million, translating to an operating margin of 29.2%. We delivered strong margins while making what we believe are the necessary investments in Abiomed 2.0, including innovation, clinical data and online training and education to drive long-term growth.

本季營業收入成長 2%，達到 1.61 億美元，營業利益率為 29.2%。我們實現了豐厚的利潤，同時對 Abiomed 2.0 進行了我們認為必要的投資，包括創新、臨床數據以及線上培訓和教育，以推動長期成長。

GAAP net income for the quarter was $62 million or $1.36 per diluted share versus $13 million or $0.28 in Q2 of '20. The year-over-year improvement was primarily driven by a mark-to-market on our shockwave investment and a lower effective tax rate. Our tax rate for Q2 was 14.7% versus 24.7% in the prior year due to higher excess tax benefits in this year's rate. We had another solid quarter on cash as we generated $77 million of operating cash flow. Our balance sheet is robust as we ended the quarter with $736 million of cash and marketable securities and no debt, which provides us continued security and flexibility.

該季度的 GAAP 淨利潤為 6,200 萬美元，即稀釋後每股收益 1.36 美元，而 20 年第二季的 GAAP 淨利潤為 1,300 萬美元，即每股稀釋收益 0.28 美元。年比改善主要是由於我們的衝擊波投資按市值計價和較低的有效稅率推動的。由於今年稅率的超額稅收優惠較高，我們第二季的稅率為 14.7%，而前一年為 24.7%。我們又一個現金充足的季度，產生了 7,700 萬美元的營運現金流。我們的資產負債表穩健，本季末我們擁有 7.36 億美元的現金和有價證券，沒有債務，這為我們提供了持續的安全性和靈活性。

With the impact of the pandemic evolving differently across geographies, we will continue to adapt to meet the needs of patients and physicians. Although there is much that remains unpredictable to provide transparency to our investors during this time, we want to give color on our top line expectations for our third quarter.

隨著大流行的影響在不同地區發生不同的變化，我們將繼續適應以滿足患者和醫生的需求。儘管在此期間為我們的投資者提供透明度仍有許多不可預測的因素，但我們希望為第三季的營收預期提供色彩。

Similar to our performance in Q2, we do expect to see a sequential improvement in revenue throughout the quarter. We expect this to be a factor of hospitals being in a better position to anticipate and be prepared with the resources needed to manage patients under the current circumstances. We also expect an increase in volume as sicker, more high-risk patients begin to return to the system for care.

與我們第二季的表現類似，我們確實預計整個季度的營收將連續改善。我們預計，這是醫院能夠更好地預測並準備好在當前情況下管理患者所需資源的因素。我們也預計，隨著病情較重、風險較高的患者開始返回系統接受護理，數量也會增加。

At this time, we expect Q3 global revenue to be in the range of $221 million to $230 million, representing flat to 4% growth compared to Q3 of last year.

目前，我們預計第三季全球營收將在 2.21 億美元至 2.3 億美元之間，與去年第三季相比成長 4%。

So in summary, despite the unpredictable environment, we delivered solid operational and financial performance in the quarter. While we navigate through the uncertainties of the pandemic, we remain focused on executing our fiscal '21 goals and transitioning to our green phase, while we continue to progress towards changing the standard of care with Impella through our proven formula of training, data and time.

總而言之，儘管環境不可預測，我們在本季仍實現了穩健的營運和財務表現。在我們克服大流行的不確定性的同時，我們仍然專注於執行我們的 21 財年目標並過渡到綠色階段，同時我們繼續通過我們經過驗證的培訓、數據和時間公式，與 Impella 一起改變護理標準。

Operator, please now open the line for questions.

接線員，現在請撥打電話提問。

(Operator Instructions) And our first question comes from Margaret Kaczor from William Blair.

（操作員說明）我們的第一個問題來自威廉·布萊爾的瑪格麗特·卡佐爾。

So first, I wanted to talk a little bit about the green phase and your comments, Mike, on being able to go on the offensive here. So can you give us a little bit more color around what that means? And then you had talked about patient cure is that something that Abiomed can directly address? Or is this more about being able to go out and kind of try to reinvigorate those referral networks and get some of these patients that maybe are backlogged or on the sidelines and get them into hospitals coming up in the fiscal third quarter?

首先，我想談談綠色階段以及你對能夠在這裡發動攻擊的評論，麥克。那麼你能給我們更多關於這意味著什麼的資訊嗎？然後您談到患者治癒是 Abiomed 可以直接解決的問題嗎？或者這更多的是能夠走出去，嘗試重振這些轉診網絡，並讓一些可能積壓或處於觀望狀態的患者進入第三財季即將到來的醫院？

Thanks, Margaret, for the question. And let me start by saying that I am very optimistic about the quarter and getting to green as well as the fiscal year, the impressive work the engineering and the clinical teams are doing and most important in the future. So let me cover what it means to go to green.

謝謝瑪格麗特提出的問題。首先我要說的是，我對本季、走向綠色以及本財年非常樂觀，工程和臨床團隊正在做的令人印象深刻的工作，也是未來最重要的工作。那麼讓我來介紹一下走向綠色意味著什麼。

So in this transition to the green, it means we want to treat more patients than ever before because the population at the hospitals is greater than it's ever been because the patients are sicker, door to balloon times longer, non-STEMI patients wait longer. So everything is -- every patient sicker has a higher risk. We don't have elective cases at Abiomed. We have high-risk PCI. We have urgent and we have emergent. And our patients have some of the highest risk factors of any patient in the hospital from a cardiovascular perspective. So that part of us needs, it means we need to be better able to adapt and execute. And the way we're doing that is working with the hospitals and the societies, which are much better prepared. I mean that it starts with being prepared. So have more knowledge around COVID. We know it's airborne. We have better testing from temperatures to looking your SpO2. And in house, we have testing for PCR, antigen and antibodies. And some of those tests are within 48 hours or some within 1 hour. And now we're routinely testing in our Danvers facility with over 100 a week, and we're starting at now in Aachen. Treatment is better. There are those that have immunity from having it already, and then, of course, everyone is waiting for the vaccines. But what that leads us to is having our plan where we know what we can control, we know what we can influence and we know what we endure. And so we're controlling the things around heads and investments and the regulatory milestones, the engineering. We're influencing things by helping with training and education online. We're helping with CAMP PCI and directly connecting with physicians. And then we just have to endure certain things, like the referral pattern or the ICUs filling up. And where we seek to influence those things, we can do work by working with the societies, by working with our physician champions for roadshows and also running commercials that are a combination of public service to identifying needs of Protected PCI. So those are the things we're doing. And again, we're very optimistic about the second half of the year.

因此，在向綠色轉型的過程中，這意味著我們希望治療比以往更多的患者，因為醫院的人數比以往任何時候都多，因為患者病情加重，球囊進入的時間更長，非STEMI 患者等待的時間更長。所以一切都是——每個病情加重的患者都有更高的風險。我們 Abiomed 沒有選擇性病例。我們有高風險 PCI。我們有緊急的，我們有緊急的。從心血管角度來看，我們的患者擁有醫院所有患者中最高的一些危險因子。所以我們的這一部分需要，這意味著我們需要能夠更好地適應和執行。我們這樣做的方式是與醫院和社會合作，他們已經做好了更充分的準備。我的意思是，一切從做好準備開始。因此，要更了解新冠病毒。我們知道它是在空中傳播的。我們有更好的測試，從溫度到觀察您的 SpO2。我們在內部進行 PCR、抗原和抗體測試。其中一些測試在 48 小時內完成，有些則在 1 小時內完成。現在，我們在丹佛斯工廠進行例行測試，每週進行 100 多次測試，我們從亞琛開始。治療效果比較好。有些人已經具有免疫力，當然，每個人都在等待疫苗。但這會導致我們制定計劃，讓我們知道我們可以控制什麼，我們知道我們可以影響什麼，我們知道我們可以忍受什麼。因此，我們正在控制有關負責人和投資以及監管里程碑和工程的事情。我們透過幫助線上培訓和教育來影響事物。我們正在幫助 CAMP PCI 並直接與醫生聯繫。然後我們就必須忍受某些事情，例如轉診模式或 ICU 人滿為患。在我們尋求影響這些事情的地方，我們可以透過與社會合作、與我們的醫生冠軍合作進行路演以及投放結合公共服務的廣告來確定受保護的 PCI 的需求。這些就是我們正在做的事情。再說一遍，我們對今年下半年非常樂觀。

Okay. Great. And then if I can, I'll ask a little bit about the third quarter guidance, which sort of stems into that. You guys are assuming a pretty sequential -- a pretty nice sequential increase as we go into that third quarter, up mid-single digit. So as we think about what that number implies, it doesn't seem to necessarily imply some kind of incremental COVID headwinds you just spoke to potentially not getting those and thinking you're better prepared. But just kind of give me a range if you can of what gets you on the low and the high end and maybe above or below that range?

好的。偉大的。然後，如果可以的話，我會詢問一些有關第三季度指導的問題，這就是源於此。你們假設一個相當連續的——當我們進入第三季時，一個相當不錯的連續成長，成長到中個位數。因此，當我們思考這個數字意味著什麼時，它似乎並不一定意味著您剛才談到的某種增量新冠逆風可能沒有得到這些逆風，並認為您已經做好了更好的準備。但如果可以的話，請給我一個範圍，什麼能讓你處於低端和高端，也許高於或低於該範圍？

Yes. Thanks, Margaret. So this is Todd. I'll take that one. So we do -- as I mentioned in my prepared remarks, we do expect to see sequential improvement from Q2 to Q3 as the gradual recovery continues and the seasonality of our business. So again, forecasting, depending on the range, growth of 5% to 10% on a sequential basis. I would say, the low end of the guidance assumes some impact of the COVID resurgence within the quarter. As we see it today in the specific hot spots, really not expecting to see the full recovery within the quarter that we've seen in the past. So if you think about Florida, we saw resurgence cases in July, but made a strong recovery in August and September and actually grew year-over-year quarter. So the timing of the bounce back of the recovery is tough to call. But as you know -- but we know it's going to happen as hospitals are better prepared to handle the resurgence. And again, our patients are not elective. They are sicker and they're in the need of hemodynamic support.

是的。謝謝，瑪格麗特。這就是托德。我會接受那個。正如我在準備好的發言中提到的那樣，隨著逐步復甦的持續和我們業務的季節性，我們確實預計第二季到第三季會出現連續改善。同樣，根據範圍，預測環比增長 5% 到 10%。我想說的是，該指引的低端假設了本季新冠疫情死灰復燃的一些影響。正如我們今天在特定熱點地區看到的那樣，確實不希望在我們過去看到的季度內看到全面復甦。因此，如果你想想佛羅裡達州，我們在 7 月看到了病例的復甦，但在 8 月和 9 月出現了強勁復甦，並且實際上同比增長。因此，復甦的反彈時機很難確定。但如你所知，但我們知道，隨著醫院為應對疫情復甦做好更好的準備，這種情況將會發生。再說一遍，我們的患者沒有選擇性。他們病情加重，需要血流動力學支持。

I would say the high end of the range, we continue to see a gradual sequential improvement, some lift from the robust clinical data from TCT that Mike highlighted earlier on the call around PROTECT III and our RESTORE EF. And again, we'll just continue to be transparent on the trends that we're seeing.

我想說的是，在範圍的高端，我們繼續看到逐步的連續改善，部分來自 TCT 的可靠臨床數據，邁克早些時候在關於 PROTECT III 和我們的 RESTORE EF 的電話會議上強調了這一點。再說一遍，我們將繼續對我們所看到的趨勢保持透明。

And our next question comes from Matthew O'Brien from Piper Sandler.

我們的下一個問題來自 Piper Sandler 的 Matthew O'Brien。

I'd like to just follow-up a little bit on the Q3 guide, especially in the U.S. I know it's a nice sequential bump that we're expecting here, but I think it's probably a little bit softer than some people may have thought just based on a little bit easier comp versus Q2 into Q3. And I think just based on what you said about the interest level in 5.5 and RP, it would imply that there's still a lot of weakness on the high-risk PCI side of things. So can you just talk a little bit about why that would be the case?

我想對第三季的指南進行一些跟進，尤其是在美國。我知道這是我們所期待的一個很好的連續性增長，但我認為它可能比一些人想像的要軟一些只是基於相對於第二季到第三季更容易的比較。我認為，根據您所說的 5.5 和 RP 的興趣水平，這意味著高風險 PCI 方面仍然存在許多弱點。那麼您能簡單談談為什麼會出現這種情況嗎？

And then, Mike, you've been doing this a long time. Is this kind of similar to what you've done historically, you're just trying to be as conservative as possible on that number, just given all these different variables that are difficult to predict?

然後，麥克，你已經這樣做很久了。這是否與您歷史上所做的類似，您只是想在這個數字上盡可能保守，只是考慮到所有這些難以預測的不同變數？

So Matt, I'll take the question. This is Mike. Thanks for the question. I think it's a good analysis to say where are we on our guidance knowing that most companies haven't given guidance for the fiscal year or for the quarter. To look back, last October was the highest patient month we've ever had in the United States in the history of the company. So October itself, as Todd mentioned, we do expect to be up sequentially from September, but it is a tougher comp. And then it gets a little bit easier as the quarter goes on. We think it's prudent to give this guidance, knowing that we are better prepared, knowing that we have new data and we do have access at most hospitals to get in with the exception of some areas in California. But we are confident that our patients are benefiting from the therapy, the societies and the hospitals are working together to treat these very sick high-risk cases or these shock cases. And we also believe that there's a range there for a reason.

馬特，我來回答這個問題。這是麥克。謝謝你的提問。我認為這是一個很好的分析，可以說明我們的指導處於什麼位置，因為大多數公司都沒有給出本財年或本季的指導。回顧過去，去年十月是我們公司史上在美國患者人數最多的月份。因此，正如托德所提到的，十月本身，我們確實預計會比九月連續上升，但這是一個更艱難的比較。隨著季度的繼續，事情會變得容易一些。我們認為給予這項指導是謹慎的，因為我們知道我們已經做好了更好的準備，知道我們有新的數據，而且我們確實可以在大多數醫院進入（除了加州的一些地區）。但我們相信，我們的患者正在從治療中受益，社會和醫院正在共同努力治療這些病情嚴重的高風險病例或休克病例。我們也相信存在一個範圍是有原因的。

In Germany, what you're seeing is there's a -- the local team has coined it. It's a COVID light resurgent, meaning that if the numbers are way up, they're anticipating and they're seeing the ICUs fill back up somewhat, but they're not as sick. And so we're balancing not just the U.S. numbers, but the global numbers. And we are taking into account that if the ICU beds fill up, it does restrict some of the care. And unfortunately, for many of our patients, we don't create a backlog. These are patients that need to be treated. And if they're not treated, unfortunately, they will die or they'll have some permanent damage that will limit the ability to treat them in the future. So we're in a situation here where, again, we're confident that we're going to be able to continue to grow sequentially with the ultimate goal of growing year-over-year, as we did in a summer quarter in Q2. But we're going to be prudent about our guidance and try to do the best to give full transparency to what we're looking at coming into this transition to green.

在德國，你看到的是當地團隊創造了這個詞。這是一種新冠病毒輕度復甦，這意味著如果數字大幅上升，他們會看到重症監護室會回升，但他們的病情並沒有那麼嚴重。因此，我們不僅要平衡美國的數據，還要平衡全球的數據。我們正在考慮到，如果 ICU 床位滿了，確實會限制一些護理。不幸的是，對於我們的許多患者來說，我們不會造成積壓。這些是需要治療的患者。不幸的是，如果他們不得到治療，他們就會死亡，或者會受到一些永久性損傷，從而限制未來治療他們的能力。因此，我們現在的情況是，我們再次有信心，我們將能夠繼續連續成長，最終目標是同比成長，就像我們在第二季夏季季度所做的那樣。但我們將謹慎對待我們的指導，並盡力使我們在向綠色過渡過程中所考慮的內容完全透明。

Okay. Fair enough. And then on the sheet side of things, great to hear that the timing for that is on track. I think you said Q3 of '21 for the limited launch there. Can you kind of frame up how often 2.5 is even used anymore in these PCI cases that we don't really get into that at this point? So given that it's going to be 2.5 with that sheet, how impactful could that product be Q3, Q4 and even into fiscal '22?

好的。很公平。然後在事情的表面上，很高興聽到時機已步入正軌。我想你說的是 21 年第三季的有限發布。您能否描述一下在這些 PCI 案例中 2.5 的使用頻率是多少，而我們目前還沒有真正討論這一點？那麼考慮到該表的值為 2.5，該產品對第三季、第四季甚至 22 財年的影響力有多大？

Matthew, question on 2.5 is used less because we have the Impella CP. However, there's probably a patient out there, population out there that doesn't get it used at all that are more female. You see that in our bail-out studies or smaller-sized individuals where that next physician group that's more worried about access closure might be more willing to use it for that patient population. And remember, the PROTECT II was only the 2.5. So we think we're going to get some of those new smaller patients, more female patients, get those doctors more comfortable. It certainly does a lot more than a balloon pump. In many cases, places are not using balloon pump, they're either just -- they're getting in and out or they're getting in and out and trying to stage and meaning they'll bring them back again in 60 days. And staging is something that is going down currently with the COVID environment. And a lot of these high-risk CABG patients are less likely to get CABG, so they're going to be referred in to interventional cardiology.

Matthew，關於 2.5 的問題很少使用，因為我們有 Impella CP。然而，可能有一些患者、那裡的人群根本沒有使用它，其中女性較多。您會發現，在我們的救助研究中，對於較小規模的個體，下一個更擔心通道關閉的醫生小組可能更願意將其用於該患者群體。請記住，PROTECT II 只是 2.5。因此，我們認為我們將接收一些新的體型較小的患者，更多的女性患者，讓醫生感到更舒適。它的作用肯定比氣球幫浦多得多。在許多情況下，地方並沒有使用氣球泵，他們要么只是進出，要么進出並試圖表演，這意味著他們會在 60 天內再次將他們帶回來。目前，隨著新冠疫情的爆發，分期的情況正在減少。許多高風險冠狀動脈搭橋術患者接受冠狀動脈繞道術的可能性較小，因此他們將被轉診至介入性心臟病學。

We also know that for high-risk PCI, that single access by our more relaxed expert and experienced user is around 40% of the Protected PCI. So they have a product they're very comfortable with single access continues to grow. And what we're doing is we're really trying to address the different levels of our users, those that are early adopters versus the early majority versus the late majority. And we know that access closure is very important, and that's why you're seeing us really leverage the PROTECT III data to show that the vascular complications are now numerically lower, and in some case, statistically better than the PROTECT II numbers, especially around the intra-aortic balloon pump.

我們也知道，對於高風險 PCI，我們更輕鬆的專家和經驗豐富的用戶的單次訪問約為受保護 PCI 的 40%。所以他們有一個他們非常滿意的產品，單一訪問持續增長。我們正在做的是真正嘗試滿足不同程度的用戶的需求，即早期採用者、早期大眾和晚期大眾。我們知道通路閉合非常重要，這就是為什麼您看到我們真正利用 PROTECT III 數據來表明血管併發症現在在數字上較低，並且在某些情況下，統計上比 PROTECT II 數字更好，尤其是在主動脈內球囊反搏器。

So we think that within the combination of the XR sheet and the new data that's out there and then our training and education program, we're really going to minimize that fear of access closure that keeps some of the physicians from holding back, and again the goal of doing a PCI is to get complete revascularization because by doing that, you enable the improvement in EF and the improvement in quality of life that's now been proven in multiple studies, including FDA studies as well.

因此，我們認為，結合 XR 表和現有的新數據以及我們的培訓和教育計劃，我們確實可以最大程度地減少對訪問關閉的恐懼，這種恐懼使一些醫生不再猶豫，並且再次進行PCI 的目標是實現完全血管重建，因為透過這樣做，您可以改善EF 和生活質量，這一點現在已在多項研究（包括FDA 研究）中得到證實。

Our next question comes from Chris Pasquale from Guggenheim.

我們的下一個問題來自古根漢的克里斯·帕斯誇萊。

Mike, just following up on the expandable sheet question, what's the timing on the CP compatible version because that's obviously more meaningful in terms of your current product mix?

Mike，接下來是關於可擴展表的問題，CP 相容版本的時間是什麼時候，因為這對於您目前的產品組合來說顯然更有意義？

What we had said and we'll -- we continue is that we're going to follow-up in the following quarter. So we're talking about end of Q3 or Q4 to submit for the CP and then depending on the cycle for that 510(k), that will lead us to the limited market release on the CP.

我們已經說過，我們將繼續我們將在下個季度採取後續行動。因此，我們正在討論在第三季或第四季末提交 CP，然後根據 510(k) 的週期，這將導致我們對 CP 進行有限的市場發布。

Okay. So still thinking about sometime in the first half of FY '22 for the market release?

好的。那麼還在考慮在 22 財年上半年的某個時間點發布市場嗎？

Correct. And I would note, though, that when we talk about Impella, one of the things to look at is TAVR. So a lot of the same centers and some of those sophisticated users, they've already mastered doing at 14 French cannula, all the way through. Remember, the Impella for the CP, it just has a 14 French motor head. The rest of the catheter and the pump is 9 French. So that's why our XR sheet is unique because it expands and recoils, so you can close with a 9 French. So that's even significantly easier than the ones who are comfortable doing a TAVR. We also know that, again, the single access technique is very popular. And most important, what PROTECT III shows is over the last 2 years, the best practice is the training. You really are looking at adverse event rates on complications such as vascular complications and bleeding similar to the rates around the balloon pump and PROTECT II. And in the case of stroke, you're looking at statistically better outcomes than what we've seen historically with balloon pump.

正確的。不過，我要指出的是，當我們談論 Impella 時，需要關注的事情之一就是 TAVR。因此，許多相同的中心和一些經驗豐富的用戶，他們已經完全掌握了 14 法式插管的操作。請記住，CP 的 Impella 只有一個 14 法國電機頭。導管和幫浦的其餘部分為 9 French。這就是為什麼我們的 XR 床單是獨一無二的，因為它可以膨脹和反沖，因此您可以用 9 French 來關閉。因此，這比那些願意進行 TAVR 的人要容易得多。我們也知道，單一存取技術非常流行。最重要的是，PROTECT III 所展示的是在過去的兩年裡，最好的實踐就是培訓。您真正關注的是血管併發症和出血等併發症的不良事件發生率，與球囊幫浦和 PROTECT II 的發生率類似。就中風而言，從統計數據來看，您會看到比我們歷史上使用球囊泵看到的結果更好的結果。

Yes. I think that's a good point, Mike. Maybe help square this for me. Given that context, vascular complications are down. We've gotten better at large bore closure. So is the expandable sheet a real catalyst for the business? Or is this sort of solving a problem that's already been solved by technology evolution in other areas?

是的。我認為這是一個很好的觀點，麥克。也許可以幫我解決這個問題。鑑於這種情況，血管併發症有所減少。我們在大口徑封閉方面做得更好。那麼可膨脹板材真的是業務的催化劑嗎？或者說，這種解決方式是否是其他領域的技術演進已經解決的問題？

It's a combination. It's all of the above, Chris. So remember, we have different sized users and different comfort levels. So what we're doing is we're giving a solution, starting with regular education. Here are the actual results of what you get and what you see in the last 2 years for vascular complications, bleeding and stroke.

這是一個組合。以上就是這些，克里斯。因此請記住，我們有不同規模的用戶和不同的舒適度。所以我們正在做的是提供一個解決方案，從常規教育開始。以下是您在過去兩年中所得到和所看到的血管併發症、出血和中風的實際結果。

And the one thing to point out in the circulation publication of amine, it does not give net outcomes for any of those 3 components. It just gives an odds ratio. So we continue to try to pursue circulation to put out the net numbers because in our own investigation and buying the data, you'll see that all of those are single-digit -- they're lower. But because you have 4,000 Impella patients and 40,000 balloon pump patients, you can get a p-value difference of 1%. When it's low single digits, it's reasonable in the database that doesn't even track it. So we're going to continue to drive the education. We believe that where we are today, in best practices, is that we've really gotten those adverse event rates to a very reasonable number and the overwhelming benefit of the hemodynamic support and being able to achieve complete revascularization is really the message you're hearing from the physicians around the PROTECT III data as well as in RESTORE EF, proving to physicians if we're going to do high-risk PCI, the ultimate goal is to do the best we can in a single setting because it has an improvement in the patient's quality of life and ejection fraction, the same way you get for CABG, where they remove and sow a vein in without having the invasive of a sternotomy. So it's the most exciting time for us as far as clinical data, education and training.

在胺的流通出版物中需要指出的一件事是，它沒有給出這三個組成部分中任何一個的淨結果。它只是給了一個優勢比。因此，我們繼續努力追求流通以公佈淨數字，因為在我們自己的調查和購買數據中，您會發現所有這些都是個位數 - 它們較低。但由於您有 4,000 名 Impella 患者和 40,000 名球囊幫浦患者，因此您可以獲得 1% 的 p 值差異。當它是低個位數時，資料庫中甚至不追蹤它是合理的。因此，我們將繼續推動教育。我們相信，在最佳實踐中，我們今天所處的位置是，我們確實已將這些不良事件發生率降至非常合理的數字，並且血流動力學支持的壓倒性優勢以及能夠實現完全血運重建確實是您要傳達的訊息聽取醫生關於 PROTECT III 數據以及 RESTORE EF 數據的意見，向醫生證明，如果我們要進行高風險 PCI，最終目標是在單一環境中做到最好，因為它有改進患者的生活品質和射血分數，與CABG 的方式相同，他們在不進行侵入性胸骨切開術的情況下移除並植入靜脈。因此，就臨床數據、教育和培訓而言，這對我們來說是最令人興奮的時刻。

And the COVID world has really opened up a new opportunity for us. We have planned to do online training and education in live cases, but we're going to be able to have more input now than ever before with online training and education. We do weekly cases where our users log in. And because they have password protected identification, we know who they are. We know their outcomes. We know their indications. We know where they're at from Impella Connect with the sole goal of getting them trained and making them more comfortable so they can continue to improve outcomes for both high-risk PCI and cardiogenic shock.

新冠病毒世界確實為我們開闢了新的機會。我們計劃在現場案例中進行線上培訓和教育，但我們現在將能夠透過線上培訓和教育獲得比以往更多的投資。我們每週都會進行使用者登入的案例。由於他們有密碼保護的身份識別，我們知道他們是誰。我們知道他們的結果。我們知道他們的跡象。我們透過 Impella Connect 了解他們的處境，唯一的目標是讓他們接受培訓並讓他們更加舒適，以便他們能夠繼續改善高風險 PCI 和心因性休克的結果。

So while there's a lot of negative things with the COVID world, there's many things that are going to be very positive for us. And what we're trying to do is become the standard of care and train the masses from small to large centers, this whole network we have now with physicians logging on and watching cases and answering questions to each other did not exist a year ago. And so with everything we're doing from Impella Connect to online training, we think we're going to be able to get in 12 to 18 months, where we have -- it would have taken us 4 to 5 years in a normal world without COVID.

因此，儘管新冠疫情給我們帶來了很多負面影響，但也有很多事情對我們來說是非常正面的。我們正在努力做的是成為護理標準並培訓從小到大中心的群眾，我們現在擁有的整個網絡，醫生登錄並觀察病例並互相回答問題，一年前還不存在。因此，透過我們所做的一切，從 Impella Connect 到線上培訓，我們認為我們將能夠在 12 到 18 個月內完成，而在正常情況下我們需要 4 到 5 年的時間沒有新冠病毒。

That's helpful. And just last one for me, picking up on your point about maybe some silver linings to what we've gone through this year. You've highlighted some of the COVID-related approvals that you've gotten over the past 6 months or so. Are you actually seeing meaningful utilization in COVID patients who you wouldn't otherwise be treating? Can you quantify the impact of that at all?

這很有幫助。我想講最後一點，談談你的觀點，也許我們今年所經歷的事情還有一線希望。您重點介紹了在過去 6 個月左右的時間裡獲得的一些與新冠肺炎相關的批准。您是否真的看到了對新冠患者的有意義的利用，而您本來不會治療這些患者？您能量化其影響嗎？

I think there's 2 pieces to that answer, Chris. First is that the majority of all our patients, because of COVID, they're sicker. So an average door to balloon time now is 3x higher than it's been. The non-STEMI's have a higher mortality rates. STEMI's have a higher mortality rate. So the -- it is increasing that component of the patients are sicker when they get to the hospital. For COVID itself, we're getting some incremental opportunity, but I still think there's a lot more education we need to do both around pulmonary embolism for people that get right heart failure as well as ECPELLA and just unloading in general. So we're going to continue to further publish papers on that -- on those populations.

我認為這個答案有兩個部分，克里斯。首先，我們大多數的患者由於新冠病毒而病情加重。因此，現在平均從門到氣球的時間比以前增加了 3 倍。非 STEMI 的死亡率較高。 STEMI 的死亡率較高。因此，當病人到醫院時病情加重的比例正在增加。對於新冠肺炎本身，我們正在獲得一些增量機會，但我仍然認為，我們需要圍繞肺栓塞對患有右心衰竭和 ECPELLA 的人們進行更多的教育，並且一般來說只是卸載。因此，我們將繼續進一步發表有關這些人群的論文。

Our next question comes from Raj Denhoy from Jefferies.

我們的下一個問題來自 Jefferies 的 Raj Denhoy。

Maybe, Mike, I could start with the ECP news this week, some of the early feedback there seem to be quite positive on that device. Maybe you could describe a bit more about the path from here and what that initial early feasibility study looks like and when you transition to something a little broader?

麥克，也許我可以從本週的 ECP 新聞開始，一些早期回饋似乎對該設備非常積極。也許您可以更多地描述從這裡開始的路徑，以及最初的早期可行性研究是什麼樣子，以及何時過渡到更廣泛的領域？

Sure, Raj. So I was in Detroit for the first case. The Impella ECP has been in the works for a while. These are very difficult pumps to do. Thorsten Siess, our Chief Technology Officer, is a Co-Inventor of it. And when I bought the original Impella company, I was not able to secure ECP. And I had been trying to get it back from the day we closed on Impella. So that was a great acquisition back. That is probably the one competitive product that would compete with Impella CP, and it's now part of Abiomed's portfolio. And it did need to utilize our core Impella patents in order to come to the market.

當然，拉傑。所以我在底特律處理第一個案件。 Impella ECP 已經研發了一段時間。這些泵是很難做到的。我們的首席技術長托爾斯滕·西斯 (Thorsten Siess) 是它的共同發明者。當我購買最初的 Impella 公司時，我無法獲得 ECP。從我們關閉 Impella 的那天起，我就一直在努力把它找回來。所以這是一場偉大的收購。這可能是與 Impella CP 競爭的一款有競爭力的產品，現在它是 Abiomed 產品組合的一部分。它確實需要利用我們的 Impella 核心專利才能進入市場。

That being said, we see the market having different needs. So a high-risk PCI patient may need 4 to 6 hours of support, whereas a cardiogenic shock patient may need 4 days of support with SmartAssist algorithms, AI and run in the cloud. And then longer-term pumps that we're working with 5.5 and the Impella BTR can really focus on those chronic patients. So we've got components that we're working on.

話雖這麼說，我們看到市場有不同的需求。因此，高風險 PCI 患者可能需要 4 至 6 小時的支持，而心因性休克患者可能需要 4 天的 SmartAssist 演算法、人工智慧和在雲端運行的支援。然後，我們正在使用 5.5 和 Impella BTR 的長期幫浦可以真正專注於那些慢性病患者。所以我們已經有了正在開發的元件。

Now what the path is for ECP is you have a product -- early feasibility process with the FDA. So we're looking to do the first 5 patients, which we should be done with shortly for high-risk PCI, will do a preliminary screen with the safety monitor and go back to the FDA to do the next 20. They consider that the pilot phase, and that will be an ongoing process. After the pilot phase is over, within anticipating -- and this has not been confirmed and agreed upon yet with the FDA, but our current plans would be that we'll move into more formal of a pivotal study. We'll be now going a bigger number in high-risk PCI, and we'll most likely be comparing it to our current data that we have coming in on the multiple studies for the Impella 2.5 and CP, especially from the PROTECT III data set.

現在 ECP 的路徑是您擁有一個產品——與 FDA 的早期可行性流程。因此，我們希望對前 5 名患者進行治療，我們應該很快就會進行高風險 PCI 治療，將使用安全監測器進行初步篩檢，然後返回 FDA 進行接下來的 20 名患者。他們認為試點階段，這將是一個持續的過程。在試點階段結束後，正如預期的那樣——這尚未得到 FDA 的確認和同意，但我們目前的計劃是，我們將進入更正式的關鍵研究。我們現在將在高風險 PCI 中進行更多的研究，並且我們很可能會將其與我們在 Impella 2.5 和 CP 的多項研究中獲得的當前數據進行比較，特別是來自 PROTECT III 資料放。

So that's the current plan. But the nice thing about the early feasibility process is once you enter the United States, and we're here. And it's not going to go away. We're going to continue now to expand the number of centers that get access to ECP as we continue down the path to get approval.

這就是目前的計劃。但早期可行性流程的好處是，一旦您進入美國，我們就在這裡。而且它不會消失。隨著我們繼續獲得批准，我們現在將繼續擴大獲得 ECP 的中心數量。

And just to put a finer point on that. So when you move into that pivotal, say, late this year -- late this fiscal year, maybe really next, when do you think that product might ultimately get approved for a much broader use?

只是為了更詳細地闡述這一點。因此，當你進入這個關鍵時刻時，比如說，今年年底 - 本財年年底，也許真的是下一個，你認為該產品什麼時候可能最終獲得批准用於更廣泛的用途？

Yes. Raj, it's a valid question. With everything going on right now, let us get through the early feasibility study. And we can tell you that, but it's going well. It's a pretty incredible product. 9 French, now you're talking about something that's essentially a similar size to a balloon pump, but it actually can flow at rates similar to the Impella CP. So it's a dynamic breakthrough product. I think all the physicians that have been waiting for it are excited. And I hear from many physicians that say, now all my partners will use the ECP. But what we're trying to do with their partners is show them today, they can get low adverse event rates and vascular complications of bleeding with today's product with training, the XR sheet will make it better and then obviously, the ECP will make it even easier. So that's our path.

是的。拉吉，這是一個有效的問題。現在一切都在進行中，讓我們完成早期的可行性研究。我們可以告訴你，但一切都很順利。這是一個非常令人難以置信的產品。 9 French，現在您談論的是本質上與氣球泵尺寸相似的東西，但它實際上可以以與 Impella CP 相似的速率流動。所以它是一個充滿活力的突破性產品。我想所有一直在等待的醫生都很興奮。我聽到許多醫生說，現在我所有的合作夥伴都將使用 ECP。但我們今天試圖與他們的合作夥伴一起做的是向他們展示，透過今天的產品和培訓，他們可以獲得較低的不良事件發生率和出血血管並發症，XR 片將使情況變得更好，然後顯然，ECP 將使之變得更好甚至更容易。這就是我們的道路。

Great. And then sort of similar questions on PROTECT IV. With PROTECT III now having been presented, it sounds like you're moving aggressively with PROTECT IV. But I don't think you've ever fully outlined for us the size of that trial, how many sites when you think it might be -- when it might be done? So anything you're willing to offer today on the path there?

偉大的。然後是有關 PROTECT IV 的類似問題。現在 PROTECT III 已經推出，聽起來您正在積極推進 PROTECT IV。但我認為您沒有向我們全面概述過該試驗的規模，您認為可能有多少個站點，什麼時候可以完成？那麼今天你願意在通往那裡的道路上提供什麼嗎？

Sure. One of the benefits, again, at COVID is the physicians now are routinely online. So we've had a weekly calls on PROTECT IV. If you look at the Executive Committee, the PIs, the Technical Committee, these are the world leaders in both their trialists, world leaders in studies around stenting or valves. And we've got complete engagement. We've locked in the protocol. We've locked in the steering committee, the country leaders. It will be a global study. It does not require an FDA IDE because we're already on label. However, we're working with the FDA to ensure that they know what we're doing, and we're looking at many things to potentially expand our label later on and we've routinely worked with the FDA and give them an update every quarter. So we'll let them know how we're moving, but it also give us the ability to move faster. We expect to have 1,200 patients. It will be an adaptive design plus there'll be a registry of another 30 or another 1,000 patients that are not in the study that will track. A big challenge will be to make sure from an ethics perspective that all patients are randomized. We'll be able to do that because we'll know every patient at every center because of Impella Connect and the IQ database. And we expect to have our first patient in PROTECT IV at the end of this fiscal year or the first quarter of next fiscal year. So we're moving fast. We're excited. The reason that this study is set up to have a long duration of tracking. So after the first year, we're then going to start looking at the data from 30 days to 6 months to up to 3 years. We really believe there's a separation of the curve for patients that get better revascularization and see an improvement in their EF. And because of that and the way the study is set up is it really is designed to have the strongest recommendation to meet all the requirements for a Class I guideline, which would then essentially mandate usage of this device, not just here in the U.S., but in a sense, globally.

當然。新冠疫情的好處之一是醫生現在經常在線上。因此，我們每週都會就 PROTECT IV 進行通話。如果你看看執行委員會、PI、技術委員會，他們都是試驗者的世界領導者，支架或瓣膜研究的世界領導者。我們已經完全投入。我們已經鎖定了協議。我們已經鎖定了指導委員會和國家領導人。這將是一項全球性研究。它不需要 FDA IDE，因為我們已經在標籤上。 However, we're working with the FDA to ensure that they know what we're doing, and we're looking at many things to potentially expand our label later on and we've routinely worked with the FDA and give them an update every四分之一.因此，我們會讓他們知道我們的進展情況，但這也讓我們能夠更快地採取行動。我們預計將有 1,200 名患者。這將是一個適應性設計，此外還將登記另外 30 名或另外 1,000 名未參與追蹤研究的患者。一個巨大的挑戰是從倫理角度確保所有患者都是隨機的。我們之所以能夠做到這一點，是因為有了 Impella Connect 和 IQ 資料庫，我們將了解每個中心的每位患者。我們預計在本財年末或下財年第一季迎來第一個接受 PROTECT IV 治療的患者。所以我們進展很快。我們很興奮。這項研究之所以設立，是為了有較長的追蹤持續時間。因此，第一年後，我們將開始查看 30 天、6 個月甚至 3 年的數據。我們確實相信，對於獲得更好的血管重建並看到 EF 改善的患者來說，曲線存在分離。正因為如此，以及這項研究的建立方式，它確實旨在提供最有力的建議，以滿足 I 類指南的所有要求，然後該指南基本上會強制使用該設備，而不僅僅是在美國，但從某種意義上說，是全球性的。

And as you've been watching with the balloon pump, the balloon pump is Class III, meaning it's harmful for shock in Europe and Asia. And now the Class -- it's -- balloon pump is Class III harmful in the United States by the Surgical Associations for patients that can't come off the heart-lung machine post-CABG. So it's a really important thing that we both get Class I guidelines for Impella as the world moves the balloon pump to Class III and list it more as harmful. So it's an exciting time. That's a great group, and I think PROTECT IV is going to be probably one of the most revolutionary clinical studies in all of cardiovascular medicine.

正如您一直在觀察氣球泵一樣，氣球泵是 III 級，這意味著它在歐洲和亞洲對休克有害。現在，這種球囊幫浦在美國被外科協會評定為 III 級危害，適用於在 CABG 後無法脫離心肺機的患者。因此，隨著世界將氣球泵移至 III 級並將其列為更有害的物質，我們都獲得 Impella 的 I 級指南是一件非常重要的事情。所以這是一個令人興奮的時刻。這是一個很棒的團隊，我認為 PROTECT IV 可能會成為所有心血管醫學領域最具革命性的臨床研究之一。

But I guess, 1,200 patients and now you're describing a potential follow-up period that could be as long as 3 years. When do you think you'll be in a position with enough data to actually move to where it could justify moving to the -- to a Class I indication? Maybe a follow-up, too, is, when do you think that 1,200 patients might be enrolled, so we could even start to see some early 90-day kind of endpoint data from it?

但我猜想，1,200 名患者現在正在描述可能長達 3 年的潛在追蹤期。您認為什麼時候您將擁有足夠的資料來實際轉移到可以證明轉移到 I 類指示的合理位置？也許後續行動是，您認為什麼時候可以招募 1,200 名患者，這樣我們甚至可以開始從中看到一些早期 90 天的終點數據？

Yes. It's a good question. And in some cases, a lot of times companies do 30 days or 90 days because they're rushing to get to the number to get the p-value. So they can go before the FDA panel and get approval. We already have that approval.

是的。這是一個好問題。在某些情況下，很多時候公司會這樣做 30 天或 90 天，因為他們急於獲得數字以獲得 p 值。這樣他們就可以向 FDA 小組提交申請並獲得批准。我們已經得到了批准。

So the way it's going to work, Raj, is at the end of one year after the last patient that we're going to have the data, then we have to process it. But it's really think of it as one year after the last patient is up to 3 years of tracking, we'll be then putting out the data. But what we'll have in that data is we'll have the 30-day to 6-month or 1 year and then beyond that. So that we'll have the kind of data that you really need to show what happens when you do better revascularization. And what we expect to happen is our patients will have better, yes, more active. And our PROTECT III data set shows our best practices, but the RESTORE EF protocol is similar to PROTECT IV, which really continues to show that you can treat these patients get a massive improvement. So if you're talking about a net 10% to 15% improvement in EF. So if you have a 30% EF going into a Protected PCI, you come out with 45%. Your quality of life is different. If your EF goes up that much, it improves the curves on your survivability. So we're going to test that. And they also feel better, in many cases, avoid having to have an ICD. So there's a cost savings for that as well.

因此，拉傑，它的運作方式是在最後一位患者獲得數據後的一年年底，然後我們必須對其進行處理。但實際上，在對最後一名患者進行長達 3 年的追蹤一年後，我們將發布數據。但我們將在該數據中獲得 30 天到 6 個月或 1 年以及更長的時間。這樣我們就能獲得您真正需要的數據來顯示當您進行更好的血管重建時會發生什麼。我們期望發生的是我們的患者會變得更好，是的，更活躍。我們的 PROTECT III 資料集顯示了我們的最佳實踐，但 RESTORE EF 協議與 PROTECT IV 類似，這確實繼續表明您可以在治療這些患者方面獲得巨大的改善。因此，如果您談論的是 EF 淨改善 10% 到 15%。因此，如果您有 30% 的 EF 進入受保護的 PCI，那麼您將獲得 45%。你的生活品質是不同的。如果你的 EF 上升那麼多，它就會改善你的生存能力曲線。所以我們要測試一下。在許多情況下，他們也感覺更好，避免了安裝 ICD。因此這也節省了成本。

So that's the reason we're doing this. We already have the label. We've already shown the best practices. But the PROTECT IV is really swinging for defenses to document that this is the way to go, similar to the way TAVR has proceeded and driven the conversion for their patients.

這就是我們這樣做的原因。我們已經有了標籤。我們已經展示了最佳實踐。但 PROTECT IV 確實在為防禦提供支持，以證明這是可行的方法，類似於 TAVR 進行並推動患者轉變的方式。

Great. I just want to squeeze one last one because I don't think we've had a chance to ask you about this since it came out last month. But the final reimbursement rates for Impella DRG 2.15 it was down, I think, roughly 11%. Any broad thoughts you want to offer on if that's going to have an impact and kind of really the future direction of reimbursement?

偉大的。我只想擠出最後一點，因為自上個月發布以來，我認為我們沒有機會向您詢問此事。但我認為 Impella DRG 2.15 的最終報銷率下降了約 11%。如果這會產生影響並且確實是未來報銷的方向，您想提出什麼廣泛的想法嗎？

Yes. We always say the reimbursement exercise is a math exercise. So if the hospital charges go up, then the reimbursement goes up. If hospital charges go down, then it goes down. Remember, though, we have a mix of patients. We have a high-risk PCI to shock. So if a patient is high-risk PCI and they do well and discharge them, they can make a little money. If the patient is in shock and not everything goes well, they can lose money. So what they do for those is they submit outlier payments to get back some of the reimbursement. And if the CMS gets it wrong and that hospital charge is higher, it goes up the following year. So we continue to monitor it. I don't see this as an impact pro or negative, and we've talked about that for years. Because what's happened is CMS, HHS and the federal government has set up a system that there's multiple ways to get paid for Impella, whether you're at the hub or the spoke, you can get DRG 1, you can get DRG 3 with ECPELLA. You can get DRG 1 with biventricular Impella, you can get 2.15, which is the DRG you're talking about where you can get DRG 2.68, which means you've accepted Impella on -- a patient on Impella already. Three of the 4 have gone up. And so it's a system of care. We're very grateful to CMS and the FDA that they've given us exclusive FDA approvals as safe and effective. And we're especially appreciative to CMS that they've given us exclusive ways to get paid for Impella that they've deemed reasonable and necessary.

是的。我們總是說報銷練習是數學練習。因此，如果醫院費用上漲，報銷費用也會上漲。如果醫院費用下降，那麼它就會下降。但請記住，我們有各種各樣的患者。我們有一個高風險的 PCI 需要震驚。因此，如果患者接受高風險 PCI，並且病情良好並出院，他們就可以賺一點錢。如果患者處於休克狀態並且一切進展不順利，他們可能會損失金錢。因此，他們所做的就是提交異常付款以收回部分報銷。如果 CMS 弄錯了，住院費用更高，那麼第二年的費用就會上漲。所以我們繼續對其進行監控。我不認為這有正面或負面的影響，我們已經討論這個問題很多年了。因為發生的事情是 CMS、HHS 和聯邦政府建立了一個系統，有多種方式獲得 Impella 的報酬，無論你是在中心還是輻射，你可以透過 ECPELLA 獲得 DRG 1、DRG 3 。您可以透過雙心室 Impella 獲得 DRG 1，您可以獲得 2.15，這就是您所說的 DRG，您可以在其中獲得 DRG 2.68，這意味著您已經接受了 Impella - 已經是 Impella 上的患者。 4 個中的 3 個上漲了。所以這是一個護理系統。我們非常感謝 CMS 和 FDA，他們給予我們安全有效的 FDA 獨家批准。我們特別感謝 CMS，他們為我們提供了獲得 Impella 報酬的獨家方式，他們認為這是合理且必要的。

Our next question comes from Danielle Antalffy from SVB Leerink.

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

Todd, maybe this question is for you, but you mentioned that July was down -- utilization was down 4% sequentially. I think that was -- I'm sorry, year-over-year, I believe. And then -- but you were up 4% for the whole quarter. Is there any way you can give us a little bit more color on what happened in August and September, obviously, would have had to grow much faster than that 4%? And then I have one follow-up.

托德，也許這個問題是問你的，但你提到 7 月的利用率下降了——利用率環比下降了 4%。我認為那是──對不起，我相信，年復一年。然後——但整個季度你上漲了 4%。您是否可以透過任何方式為我們提供更多有關 8 月和 9 月發生的情況的信息，顯然，增長速度必須比 4% 快得多？然後我有一個後續行動。

Yes, it's a good question, Danielle. I think what we talked about on the call in my prepared remarks is we did see sequential improvements in patients in August versus July and September versus August. So again, we continue to see the sequential improvement in both revenue and as well as some patients in the U.S. and now they really, that's what our focus is on getting better each month and seeing sequential improvement. And that's what we saw in July and August and September in the U.S.

是的，這是個好問題，丹妮爾。我認為我們在電話會議上在我準備好的發言中談到的是，我們確實看到了 8 月與 7 月以及 9 月與 8 月相比患者的連續改善。再說一次，我們繼續看到美國的收入和一些患者的連續改善，現在他們真的，這就是我們的重點是每個月變得更好並看到連續改善。這就是我們在美國七月、八月和九月看到的情況。

Okay. Is it fair to say maybe -- I mean, just doing the math, I mean, it would have had to be relatively meaningfully to get to that 4% for the quarter, is that fair to say?

好的。公平地說，也許——我的意思是，只要做一下數學計算，我的意思是，要在本季度達到 4%，就必須相對有意義，這樣說公平嗎？

If you look at -- if you do the math, and again, it's some of it's just a year-over-year comparison, I would say, 4% in July. We got a little bit better in August. In July -- in September, I'd say it's a little bit probably more kind of breakeven on a year-over-year perspective.

如果你再算一下，你會發現其中一些只是同比比較，我想說，7 月份為 4%。八月我們的情況有所好轉。在七月——九月，我想說，從同比的角度來看，這可能會更接近收支平衡。

Got it. Okay. And then my follow-up is around how to look at the go-forward growth outlook ex-COVID sort of getting rid of all the noise around COVID. And one of the things we've been hearing is that the high-volume users are still very much believers in Abiomed. So I was wondering if there's any -- it's been the lower volume users that have been sort of declining -- seeing declines in usage. And so I was wondering if you could help us sort of characterize how the high-volume users have been growing versus the low-volume users and sort of bridge us to, what's the go-forward ex-COVID outlook could be just sort of looking at those different dynamics?

知道了。好的。然後我的後續行動是如何看待新冠疫情之後的未來成長前景，消除圍繞新冠疫情的所有噪音。我們聽到的一件事是，大量用戶仍然非常相信 Abiomed。所以我想知道是否存在使用量下降的情況，即數量較少的用戶一直在下降。因此，我想知道您是否可以幫助我們描述高流量用戶與低流量用戶的成長情況，並幫助我們了解新冠疫情之後的未來前景是什麼？在那些不同的動態下？

Danielle, thanks for the question. So it's a very good question. It's something we track. And we have such visibility to our doctors, our indications and our hospitals that we track this on a daily basis. And we get an e-mail for every patient all day long. And if it's an independent, we ultimately find out about it, either it's on Impella Connect directly, so we know about it or in a reorder.

丹妮爾，謝謝你的提問。所以這是一個非常好的問題。這是我們追蹤的東西。我們對我們的醫生、我們的適應症和我們的醫院非常了解，因此我們每天都會追蹤這些情況。我們整天都會收到每位患者的電子郵件。如果它是獨立的，我們最終會發現它，要么直接在 Impella Connect 上，所以我們知道它，要么在重新排序中。

That being said, as we've been analyzed, the actual smaller-to-medium hospitals have gone up sequentially in the 20% range, but they actually are up year-over-year in Q2. And the reason is, is because these patients don't want to go far. You're going to see this trend where you're going to end up with more spoke hospitals, those physicians are doing -- the patients are sicker when they do high-risk PCI or potentially that's where they're going for shocks. So collectively, we're doing pretty well in those centers. It's a good trend for us. It's widening online and training education is helpful. We can get those physicians to log in and watch cases on CAMP PCI. They can ask questions of the experts. They can even get proctored, if they go through the study or a curriculum that's online as well.

話雖這麼說，正如我們分析的那樣，中小型醫院實際環比增長了 20%，但實際上第二季度同比增長了。原因是，因為這些病人不想走太遠。你會看到這種趨勢，你最終會去更多的輻照醫院，那些醫生正在做的事情——當病人進行高風險PCI 時，他們的病情會加重，或者可能這就是他們遭受休克的地方。總的來說，我們在這些中心做得很好。這對我們來說是一個好的趨勢。它在網路上不斷擴大，培訓教育很有幫助。我們可以讓這些醫生登入 CAMP PCI 並觀看病例。他們可以向專家提問。如果他們也參加了線上研究或課程，他們甚至可以得到監督。

Now when you end up looking at the large centers, so our top 20 centers that we've talked about in the past that do about 50%, they're up also in the 20% range sequentially in Q2, which is a good trend. But you're looking at in being down a little bit from 5% to 10%. And we think there's a couple of things for that reason. One is they're already doing the high volume. So when their referrals get cut down or physicians in the community don't want to refer into the big center, that hurts them. And one of the reasons that we speculate is because they've become the COVID hubs, right? They're the big centers, and they're -- they tend to take the biggest bolus of the COVID patients. So that challenges them a little bit. And when you have a flare-up, a resurgence, their ICU beds either fill up or it's the fear of filling up. So that's one.

現在，當你最終看到大型中心時，我們過去討論過的前 20 個中心的佔比約為 50%，它們在第二季度的增幅也在 20% 的範圍內，這是一個很好的趨勢。但你預計會從 5% 下降到 10%。我們認為有幾個原因。一是他們已經在做大量的工作。因此，當他們的轉診次數減少或社區醫生不想轉診到大中心時，這就會傷害他們。我們推測的原因之一是它們已經成為新冠病毒中心，對嗎？他們是大中心，他們往往會接受最大量的新冠患者的藥丸。所以這對他們來說有點挑戰。當病情突然發作、復發時，他們的加護病房病床要不是已經滿了，就是擔心床位滿了。這就是其中之一。

The other reason that we think we can help them is we're going to go out and start running our commercials in these areas. And our commercials won't be the classic Protected PCI or cardiogenic shock. They're going to have a feel of a public service message that will then ask them if they do have chest pain, these are things they shouldn't stay home and then recommend that they, of course, consult with their physicians and look for experts. And so we'll get that referral program back.

我們認為我們可以幫助他們的另一個原因是我們將走出去並開始在這些地區投放我們的廣告。我們的廣告不會是經典的受保護 PCI 或心因性休克。他們會感受到公共服務訊息，然後會詢問他們是否確實有胸痛，這些是他們不應該留在家裡的東西，然後建議他們當然諮詢他們的醫生並尋找專家。所以我們會恢復推薦計畫。

And last is on access. Even with the resurgence, with Impella Connect, we have access all the time for all these patients. We also have a call center, and we also have our people that majority of -- all of our field-based trainers and people have access to the hospitals with exception of some hospitals in California. In Germany, where we're seeing another resurgence, remember that it's not for essential workers. So our Aachen facility staying open, and our field team is also maintaining revelance and access into those hospitals as well. So that's what we're watching. We think, we can help our largest centers. The interest is still there. They're super excited about PROTECT III. And you're going to see that, that PROTECT III is being presented. And the road shows we used to do where we have to fly into the city, those roadshows are happening online almost every week, multiple nights a week with 50 to 150 physicians on calls, learning about all our new data. So thanks for the question.

最後是訪問。即使疫情捲土重來，透過 Impella Connect，我們仍可以隨時為所有這些患者提供服務。我們還有一個呼叫中心，我們的員工中的大多數人——我們所有的現場培訓師和員工都可以進入醫院，除了加州的一些醫院。在德國，我們看到了另一次復甦，請記住，這不是針對重要工作人員的。因此，我們的亞琛工廠保持開放，我們的現場團隊也保持對這些醫院的了解和進入。這就是我們正在關注的。我們認為，我們可以幫助我們最大的中心。興趣還在。他們對 PROTECT III 感到非常興奮。您將會看到 PROTECT III 正在呈現。我們過去在必須飛到城市的地方進行路演，這些路演幾乎每週都在網上進行，每週多個晚上，有 50 到 150 名醫生隨叫隨到，了解我們所有的新數據。謝謝你的提問。

Our next question comes from David Lewis from Morgan Stanley.

我們的下一個問題來自摩根士丹利的大衛劉易斯。

This is Calvin on for David. Just 2 questions for me. The first is, it's a little bit of a follow-up question to Danielle's question. Just could you help us digest a little bit more on business trends this quarter versus the June and July trends that you shared last quarter? It appears this quarter, Impella revenue is up 1%. So that's lower than June and July's monthly trends, which I think were 4% and 8% increases, respectively, although the underlying July patient trends is down 4%. So appreciate that September last year was a tough comp. So was there any other dynamic like were there any extra-selling days or perhaps extra patient days in the year ago period that further created some tough comp? Or what other factors could you share with us that could bridge that revenue growth relative to June and July? And I have a quick follow-up.

這是加爾文替大衛發言。只要問我 2 個問題。首先，這是丹妮爾問題的後續問題。您能否幫助我們更了解本季的業務趨勢以及您上季度分享的 6 月和 7 月趨勢？看來本季，Impella 營收成長了 1%。因此，這低於 6 月和 7 月的月度趨勢，我認為這兩個月趨勢分別增加了 4% 和 8%，儘管 7 月的潛在患者趨勢下降了 4%。所以要感謝去年九月是一場艱難的比賽。那麼，是否還有其他動態，例如去年同期是否有額外的銷售日或額外的耐心日，進一步創造了一些艱難的競爭？或者您可以與我們分享哪些其他因素可以彌補六月和七月的收入成長？我有一個快速的跟進。

Yes. So Calvin, thanks for the question. I think when you look at how our patients progressed over the quarter from July to August, September, again, every month, they got better. And some of them more, as you mentioned, a comp issue. I mean our patient growth in fiscal year '20 in September was up 24%. So it was -- we were lapping some very difficult comps in September. But again, sequentially, the patients got better from July to August to September.

是的。卡爾文，謝謝你的提問。我認為，當你看看我們的患者在這個季度從七月到八月、九月的進展時，每個月，他們都在好轉。正如您所提到的，其中一些更多的是補償問題。我的意思是，我們在 20 財年 9 月的患者成長了 24%。事情就是這樣——我們在九月進行了一些非常困難的比賽。但同樣，從七月到八月再到九月，患者的病情逐漸好轉。

And when you think about the revenue kind of walk from in Q2 from a patient to a revenue perspective. And again, patients were down 4%, but we continue to see positive sales mix as we transition from the 2.5 to CP with SmartAssist as well as the 5.0 to the 5.5 CP with SmartAssist. And so we're seeing a benefit of a positive sales mix there from a higher average selling prices. So when you kind of just think about the walk from a revenue standpoint in Q2, it's literally patients were down 4%. We saw probably 3 points of positive sales mix and then a little bit more, I would say, on the service side to get to walk from the negative 4% to the 0.

當你考慮第二季的收入時，你會從病人的角度轉向收入的角度。患者人數再次下降了 4%，但隨著我們從 2.5 過渡到帶有 SmartAssist 的 CP，以及從 5.0 過渡到帶有 SmartAssist 的 5.5 CP，我們繼續看到積極的銷售組合。因此，我們看到了平均售價較高所帶來的正向銷售組合的好處。因此，當你從第二季的收入角度考慮這項變化時，你會發現患者數量確實下降了 4%。我們看到了大約 3 個點的積極銷售組合，然後我想說，在服務方面還有更多，以便從負 4% 走向 0。

Got it. Okay. I just -- and my second question is, I wanted to clarify one point about the PROTECT III data that was presented at TCT. So I think in the presentation, you showed P2 like patients in P3 versus P2 results across both arms. So I think in last year's TCT, when you presented the interim data, you also showed a similar slide that compared P3 data to P2. But I think the patient population shown in the year ago presentation for the P3 had 469 patients, and that number declined to 373 this year and was -- so could you help us understand the difference between those 2? Was the 469 number from last year, not the P2 like cohort and perhaps a broader cohort?

知道了。好的。我只是 - 我的第二個問題是，我想澄清關於 TCT 上提出的 PROTECT III 數據的一點。因此，我認為在演示中，您在雙臂的 P3 與 P2 結果中展示了類似 P2 的患者。所以我認為在去年的 TCT 中，當您展示中期數據時，您還展示了一張類似的幻燈片，將 P3 數據與 P2 進行比較。但我認為一年前 P3 演示中顯示的患者群體有 469 名患者，今年這個數字下降到 373 名，所以您能幫助我們了解這 2 名患者之間的差異嗎？去年的 469 個數字，不是類似 P2 的隊列，甚至是更廣泛的隊列嗎？

Calvin, that's a really big question with a lot of things to clarify. So first is, I'd encourage you to go and watch the presentation again where Dr. Chuck Simonton, who gives all the details. Second I'm happy to get on the call with you after this, go through a line item. But at a high level, PROTECT III that was shown last year was interim post-approval study and the number had been growing. So now it's up to 1,600. And last year, we just gave an interim look to compare to PROTECT II, but we did not propensity match it. We did not have the landmark analysis, and we hadn't had the data adjudicated and reviewed by the core lab.

卡爾文，這是一個非常大的問題，有很多事情需要澄清。首先，我鼓勵您再次觀看 Chuck Simonton 博士的演示，他提供了所有詳細資訊。其次，我很高興在此之後與您通電話，查看一個訂單項目。但從高水準來看，去年展示的 PROTECT III 是批准後的臨時研究，數量一直在增加。所以現在已經達到1,600了。去年，我們只是進行了與 PROTECT II 比較的臨時觀察，但我們並沒有傾向去匹配它。我們沒有里程碑式的分析，也沒有核心實驗室對數據進行裁決和審查。

So what you're seeing now is essentially a publication report where we've hit a number. We're able to check all the blocks and to compare it with propensity matching, which was not done at interim. And I think the numbers you pointed out on PROTECT II were off a little bit. So we'll take that offline, but I think that answers the high level of your question.

所以你現在看到的本質上是一份出版報告，我們已經達到一個數字了。我們能夠檢查所有區塊並將其與傾向匹配進行比較，這是臨時未完成的。我認為你在 PROTECT II 上指出的數字有點偏差。所以我們將把它離線，但我認為這回答了你的問題的高水準。

Our next question comes from Marie Thibault from BTIG.

我們的下一個問題來自 BTIG 的 Marie Thibault。

I wanted to ask one here on Breethe and the recent clearance you've got there. I would love to hear a little bit more about what you're planning for the limited release and what you hope to learn from that experience?

我想問一下 Breethe 的一位人士以及你最近獲得的許可。我很想聽聽更多關於您對限量發行版的計劃以及您希望從這次經歷中學到什麼？

Thanks, Marie, for the question. Abiomed has been the leader in hemodynamic support. We've done over 10,000 patients with ECPELLA. And the reason they work well together is certain patients need oxygenation. But if you just oxygenate the body with retrograde flow, you will overwhelm or you will get retrograde flow and make the heart work more. So it's detrimental unless you can unload that patient within a period of time. Those publications have been studied, and we posted those slides online with our quarter update.

謝謝瑪麗提出的問題。 Abiomed 一直是血流動力學支持領域的領導者。我們已經對 10,000 多名 ECPELLA 患者進行了治療。它們能夠很好地協同工作的原因是某些患者需要氧合。但如果你只是用逆行血流給身體氧氣，你就會不知所措，或者你會得到逆行血流並使心臟更多地工作。因此，除非你能在一段時間內讓該病人擺脫困境，否則這是有害的。這些出版物已經過研究，我們將這些投影片與季度更新一起發佈到網路上。

And what we hope to see: one, is continue to find the best practices in the protocol whether the patient gets a 5.5 through the axillary with ECPELLA or has a CP; and then 2, we plan to start integrating with SmartAssist, looking at optimizing both the hemodynamic support and the oxygenation. So we can wean this patient appropriately so that they, again, get native heart recovery.

我們希望看到的是：一是繼續在方案中尋找最佳實踐，無論患者透過 ECPELLA 腋窩獲得 5.5 分或有 CP；然後 2，我們計劃開始與 SmartAssist 集成，著眼於優化血流動力學支持和氧合。因此，我們可以適當地讓這位患者斷奶，以便他們再次獲得自然的心臟恢復。

One of the issues in the Popalato study from Europe showed that ECPELLA has not only had better survival, but the majority of patients had native heart recovery versus just survival. And unfortunately, when you oxygenate the body at the expense of the heart, these patients that are -- that remain alive tend to either require a transplant or an transplant or in some cases, won't qualify and never get discharged from the hospital. They go to hospice care. So we really want to -- we want to maximize the integration of both functions. And there is a new population out there for just oxygenation. So it expands our patient population, and it gives us something else to add for our pediatric product line. So we're excited about it. We're going to turn our Abiomed engineering innovation and clinical research team on to ECMO. We know a lot about it. And to note with -- for the investors, I don't believe there's ever been a single FDA study on ECMO. We haven't seen an independent study sponsored by the ECMO companies in the last 15 years. And we're going to bring the research to it, the innovation and make it better. And I think we're excited now more than ever because ECMO is something that can help COVID patients and in the future, patients that also have just respiratory failure.

來自歐洲的 Popalato 研究的問題之一表明，ECPELLA 不僅具有更好的生存率，而且大多數患者的心臟自然恢復，而不是僅僅生存。不幸的是，當你以犧牲心臟為代價給身體供氧時，這些仍然活著的患者往往要么需要移植，要么在某些情況下，不符合資格並且永遠不會出院。他們去臨終關懷中心。所以我們真的想要——我們想要最大限度地整合這兩種功能。那裡有一群新的人口只是為了吸氧氣。因此，它擴大了我們的患者群體，並為我們的兒科產品線提供了其他內容。所以我們對此感到興奮。我們將把我們的 Abiomed 工程創新和臨床研究團隊轉向 ECMO。我們對此了解很多。需要注意的是，對於投資者來說，我認為 FDA 還沒有對 ECMO 進行任何研究。過去 15 年來，我們還沒有看到由 ECMO 公司贊助的獨立研究。我們將對其進行研究、創新並使其變得更好。我認為我們現在比以往任何時候都更加興奮，因為 ECMO 可以幫助新冠患者，以及未來的呼吸衰竭患者。

That's great, Mike. Just one quick follow-up along the lines of ASP pricing dynamics. It sounds like some of the shift towards the higher price devices, it sounds like a sustainable trend. I'm wondering if that's true or if there are other dynamics we should think about going forward on ASP? And then as kind of an accompanying question there. Notice that Japan, obviously, the patient performance, the growth there year-over-year was very strong, but revenue was a little weaker there. Was that just a result of fewer site openings, your console soles -- or sales there? Or was there another dynamic going on?

太棒了，麥克。這只是關於 ASP 定價動態的快速跟進。這聽起來像是向更高價格設備的轉變，這聽起來像是一個可持續的趨勢。我想知道這是否屬實，或者我們應該考慮推進 ASP 的其他動態？然後作為一個附帶的問題。請注意，日本的患者表現，年成長非常強勁，但收入稍弱。這僅僅是因為網站開放、遊戲機鞋底或銷售減少的結果嗎？或是還有其他動態在發生？

Yes. Thanks, Marie. I'll actually answer both them. So from an ASP perspective, we do continue to see that creep up. Again, it's a function of our CP pumps volume there going down. And our ASP on our 2.5 is somewhere in the $20,000 range and CP continues to increase faster. And the average selling price is somewhere around 24%, 25% there. And again, we have the same phenomenon occurring with the 5.0 and the 5.5. I mean, we're selling more 5.5s today at a higher average selling price anywhere from, let's call it, $35,000 versus the 5.0, which was somewhere in that 26%, 27%, 28% range. So I do expect to see that trend continue over the next several quarters as a mix with our business changes.

是的。謝謝，瑪麗。我實際上會回答他們兩個。因此，從 ASP 的角度來看，我們確實看到這種情況繼續蔓延。同樣，這是我們的 CP 泵流量下降的函數。我們 2.5 的 ASP 大約在 20,000 美元的範圍內，並且 CP 繼續以更快的速度成長。平均售價約 24%、25% 左右。同樣的現像也出現在 5.0 和 5.5 上。我的意思是，今天我們以更高的平均售價（我們稱之為 35,000 美元）銷售更多 5.5 車，而 5.0 車的平均售價則在 26%、27%、28% 的範圍內。因此，我確實預計隨著我們業務的變化，這種趨勢將在接下來的幾季繼續下去。

Your second question with regard to Japan, again, I think we had a very solid quarter there. Again, as you mentioned, we had -- patients who were up 29% in the quarter, they were up over 30% in the last quarter. And it was just a function of just opening fewer sites in the quarter. And we talked about that last year -- last quarter as well as last year is that we front-loaded last year some of the site openings in Japan to accelerate the CP SmartAssist -- the CP rollout there as well as the PMDA study. So I think that will normalize in the second half of the year, but it was just more of a function of less site openings that we had versus last year. We saw that same phenomenon as well in Q1. And again, I think that normalizes in the second half of the year.

你的第二個問題是關於日本的，我認為我們在那裡的季度表現非常穩定。再次，正如您所提到的，我們的患者數量在本季度增加了 29%，在上個季度增加了 30% 以上。這只是本季開設較少站點的結果。我們在去年 - 上個季度以及去年 - 上討論過，去年我們提前加載了日本的一些網站開放，以加速 CP SmartAssist - 在那裡的 CP 推出以及 PMDA 研究。因此，我認為這種情況將在下半年正常化，但這更多是因為與去年相比，我們的網站開放量減少了。我們在第一季也看到了同樣的現象。我再次認為，這種情況將在下半年恢復正常。

Our next question comes from Ross Osborn from Stephens.

我們的下一個問題來自史蒂芬斯的羅斯奧斯本。

This is Ross on for Chris. Just following up on Marie's question. Can you discuss expected contribution from Breethe in the fiscal 3Q and in the second half of the year on a stand-alone basis and in terms of ECPELLA cases?

這是羅斯替補克里斯。只是跟進瑪麗的問題。您能否單獨討論一下 Breethe 在第三財季和下半年的預期貢獻以及 ECPELLA 案例？

Yes. So thanks, Ross, for the question. I would say right now, we're expecting a very minimal impact in Q3 and probably into Q4 as well. I mean we are launching at 5 sites during the LMR. We're still working right now, I think, finalizing the pricing strategy. It will be similar to, I would say, that razor blade model that we have with Impella, where we'll sell consoles for somewhere 60,000, 70,000, 80,000 with an annual service contract and then we'll continue to sell what I call the disposables, which are the pumps and the auctionators, again, ranging from to $6,000 to $9,000. So I think that's kind of where we think the business model will be right now. Again, we'll work through the pricing strategy with the first 5 sites. But I wouldn't expect much of an impact right now from a revenue standpoint really in Q3 and for that much in Q4 as well. It's probably more of a -- fiscal year 2022 story.

是的。謝謝羅斯提出這個問題。我現在想說的是，我們預計第三季的影響非常小，也可能到第四季。我的意思是，我們將在 LMR 期間在 5 個站點啟動。我認為我們現在仍在努力敲定定價策略。我想說，這將類似於我們與 Impella 合作的剃須刀片模型，我們將以 60,000、70,000、80,000 的價格出售控制台，並簽訂年度服務合同，然後我們將繼續銷售我所說的一次性用品，即泵浦和拍賣機，價格從6,000 美元到9,000 美元不等。所以我認為這就是我們認為現在的商業模式。我們將再次對前 5 個站點制定定價策略。但從收入的角度來看，我目前預計第三季和第四季不會產生太大影響。這可能更像是一個 2022 財年的故事。

And our last question comes from Jayson Bedford from Raymond James.

我們的最後一個問題來自雷蒙德詹姆斯的傑森貝德福德。

I'll keep it quick. It's been a long call. Todd, is there a way you could approximate the split between 5.0 and 5.5 in the U.S.? And just to be clear, you locked 5.5 last summer fall, correct?

我會保持快點。這是一個漫長的通話。 Todd，有沒有辦法可以估算出全美 5.0 和 5.5 的差距？需要澄清的是，去年夏天秋天您鎖定了 5.5，對嗎？

That is correct. It's more of a Q3. I mean, I don't have the numbers of time, but we are selling more 5.5s. We have more higher revenue in 5.5s in the U.S. today as a result versus the 5.0. Now it's a function of patients, and it's also a function of site openings. As I mentioned in my prepared remarks, we opened up another 31 sites for Impella 5.5s in the last quarter versus 4 for 5.0s. So we're getting higher patients as well as higher revenue coming out of 5.5.

那是對的。這更像是第三季。我的意思是，我沒有時間，但我們 5.5 的銷量正在增加。因此，與 5.0 相比，我們今天在美國 5.5 的收入更高。現在它是患者的功能，也是站點開放的功能。正如我在準備好的發言中提到的，我們在上個季度為 Impella 5.5 開闢了另外 31 個站點，而為 5.0 開闢了 4 個站點。因此，5.5 的患者數量和收入都在增加。

Okay. How many patients did you enroll in the STEMI DTU study?

好的。您招募了多少位病患參加 STEMI DTU 研究？

What was it. Let me see the numbers.

它以前如何。讓我看看數字。

Yes. So we're at 15 sites now close to -- I think it's close to 30 patients now. That's where we're at.

是的。所以我們現在有 15 個站點，我想現在已經有接近 30 名患者了。這就是我們現在的處境。

Okay. And then just going back to an earlier question on PROTECT IV, will we see interim data either on 30-day or 90-day outcomes? Or will we have to wait for all of the data set at once after 1 year?

好的。然後回到之前關於 PROTECT IV 的問題，我們會看到 30 天或 90 天結果的中期數據嗎？或者我們必須在一年後立即等待所有資料集？

We're going to have to wait until 1 year after the last patient, but you'll already have most or much of that data already in-house. And the reason we're doing that is because now you're going to have something that will have up to 1 year that we believe is going to statistically show a difference in the curves. And we're setting the study up to have the highest level of evidence that we can meet every criteria for Class I guidelines. And to remind everyone, the people that are doing this study are the premier trialists are also the people that weigh in on the strength of guidelines in general. So that's why we're doing it this way, but we already have safe and effective FDA approval. We already have our best practices. And for those sites that are not going to be in the study, we expect to see further adoption with our training and data and time strategy.

我們將不得不等到最後一位患者一年後，但您已經在內部擁有了大部分數據。我們這樣做的原因是因為現在你將擁有長達一年的時間，我們相信統計數據會顯示曲線的差異。我們正在進行這項研究，以獲得最高水準的證據，證明我們可以滿足 I 類指南的所有標準。並提醒大家，正在進行這項研究的人是主要的試驗者，也是對整體指南的強度進行權衡的人。這就是我們這樣做的原因，但我們已經獲得了安全有效的 FDA 批准。我們已經有了最佳實踐。對於那些不會參與研究的網站，我們希望看到我們的培訓、數據和時間策略進一步採用。

Thank you. And that does conclude the question-and-answer session for today's conference. I'd now like to turn the call back over to Mike Minogue for any closing remarks.

謝謝。今天會議的問答環節到此結束。我現在想將電話轉回給麥克·米洛，請他發表結束語。

Just want to thank all our investors for your support during the journey. These are challenging times. Know that at Abiomed, we're grateful to help patients. We're optimistic about the future. And we're tracking as a company with close to $1 billion in sales, $1 billion in cash, 1,000 patents -- 1,000 patents pending and a product that will revolutionize the standard of care for patients that have heart failure and organ dysfunction that need oxygenation. So we'll follow-up with questions, if you have any. Thanks for your time, and have a good day.

只是想感謝我們所有投資者在過程中的支持。這是一個充滿挑戰的時代。要知道，在 Abiomed，我們很感激能夠幫助病人。我們對未來感到樂觀。我們正在追蹤一家銷售額接近10 億美元、現金10 億美元、1,000 項專利（還有1,000 項正在申請中）的公司，該產品將徹底改變患有心臟衰竭和需要氧合的器官功能障礙患者的護理標準。如果您有任何疑問，我們將跟進。感謝您抽出寶貴時間，祝您有美好的一天。

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone, have a great day.

女士們、先生們，感謝你們參加今天的會議。這確實結束了該程式。你們都可以斷開連線。大家，祝你有美好的一天。