ABIOMED Inc (ABMD) 2021 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Abiomed's First Quarter 2021 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I would now like to hand the conference over to your speaker today, Mr. Todd Trapp. Sir, you may begin.

女士們、先生們，感謝大家的支持，並歡迎參加 Abiomed 2021 年第一季財報電話會議。 （操作員指示）請注意，今天的會議正在錄製中。 （操作員指示）我現在想將會議交給今天的發言人托德·特拉普先生。先生，您可以開始了。

Thanks, Crystal. Good morning, and welcome to Abiomed's First Fiscal Year '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.

謝謝，水晶。早安，歡迎參加 Abiomed 的第一個財年 '21 收益電話會議。我是 Todd Trapp，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。

The format for today's call will be as follows. First, Mike will discuss the first 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，麥克將討論第一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 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. The COVID-19 pandemic has sharpened our sense of responsibility and commitment to patients and our communities. We've had to work harder and smarter during this health crisis, and I am grateful and impressed by the way in which our employees and customers have risen and given their best to meet these unprecedented challenges. During Q1, we prioritized keeping our employees safe, supporting our patients and manufacturing our life-saving heart pumps, while investing in innovation. Coronavirus has brought changes to our operations, but our focus and the core of what we do remains the same, improving outcomes for our patients with innovation and strong execution. At Abiomed, our 4 principles, operating procedures and patients-first culture, enable us to lead, manage, adapt and execute, especially in challenging times.

謝謝托德，大家早安。 COVID-19 大流行增強了我們對患者和社區的責任感和承諾。在這場健康危機期間，我們必須更加努力、更加聰明地工作，我們的員工和客戶奮起並竭盡全力應對這些前所未有的挑戰，我對此感到感激和印象深刻。在第一季度，我們優先考慮確保員工安全、支持患者並製造救生心臟泵，同時投資創新。冠狀病毒為我們的營運帶來了變化，但我們工作的重點和核心保持不變，透過創新和強大的執行力改善患者的治療結果。在 Abiomed，我們的 4 項原則、操作程序和患者至上的文化使我們能夠領導、管理、適應和執行，尤其是在充滿挑戰的時期。

We achieved our Q1 goals, including monthly sequential growth, regulatory milestones and advanced our innovation and education. Our disciplined execution in Q1 delivered one of our most productive quarters in my 16-year tenure with the company. Despite the impact of the pandemic on our commercial organization in Q1, Abiomed delivered $165 million in revenue, down 21% year-over-year. Within the quarter, we achieved monthly sequential growth in April, May and June and 4% year-over-year growth in revenue in June overall. In June, patients and revenue increased year-over-year in the U.S., Europe and Japan, as countries began to reopen and hospital restrictions were eased on high-risk, urgent and emergent patients.

我們實現了第一季的目標，包括月度環比成長、監管里程碑，並推進了我們的創新和教育。第一季的嚴格執行使我們成為我在公司 16 年任期中最富有成效的季度之一。儘管疫情對我們第一季的商業組織產生了影響，Abiomed 仍實現了 1.65 億美元的收入，年減 21%。在本季度內，我們在 4 月、5 月和 6 月實現了月度環比增長，6 月份整體營收年增 4%。 6 月份，隨著各國開始重新開放以及醫院對高風險、緊急和急診患者的限制放鬆，美國、歐洲和日本的患者數量和收入同比增長。

Abiomed remained productive and relevant in the field by supporting cases and actively educating physicians through videoconferences and broadcasting live cases with expert panels. We successfully controlled costs and expenses, driving a solid 21% operating margin, while continuing to invest $26 million in research and innovation. Our balance sheet remains robust with nearly $600 million in cash and 0 debt, and our patent portfolio now contains 884 patents and 759 patents spending.

Abiomed 透過視訊會議和與專家小組一起直播病例來支持病例並積極教育醫生，從而在該領域保持高效和相關性。我們成功控制了成本和費用，實現了 21% 的穩定營業利潤，同時繼續投資 2,600 萬美元用於研究和創新。我們的資產負債表仍然穩健，擁有近 6 億美元的現金和零債務，我們的專利組合目前包含 884 項專利和 759 項專利支出。

For today's call, I will cover the transition from our Q1 red phase to our Q2 yellow phase and our transformation into Abiomed 2.0 in fiscal '21. We are investing in and executing on our plan for innovation, driving smaller, smarter, more connected products along with strengthening our training, education and clinical evidence. As we discussed on our last earnings call, for the fiscal year, we designated a 3-phase red, yellow, green plan, challenging realities of the COVID-19 environment. We called Q1 red because the broad state of restrictions on elective cases and limited access to most hospitals along with limitations on travel, in-person meetings and normal headquarters operations.

在今天的電話會議中，我將介紹從第一季紅色階段到第二季黃色階段的過渡以及我們在 21 財年向 Abiomed 2.0 的轉型。我們正在投資並執行我們的創新計劃，推動更小、更聰明、更互聯的產品，同時加強我們的培訓、教育和臨床證據。正如我們在上次財報電話會議上所討論的那樣，我們在本財年指定了一個紅、黃、綠三個階段的計劃，挑戰了 COVID-19 環境的現實。我們將第一季稱為紅色，因為對選擇性病例的廣泛限制和進入大多數醫院的限制，以及旅行、面對面會議和正常總部運作的限制。

In Q1, we focused on completing the SmartAssist console upgrades and accelerating the rollout of Impella Connect. Both technologies help treatment ease of use and potentially improve outcomes. We now have 1,025 sites with SmartAssist and 257 U.S. sites online with Impella Connect, more than doubling the number of connected accounts since March. Additionally, 402 sites already have the hardware on the console, and we only need hospital WiFi permission to activate the Impella Connect account.

第一季度，我們專注於完成 SmartAssist 控制台升級並加速 Impella Connect 的推出。這兩種技術都有助於提高治療的易用性，並有可能改善治療結果。目前，我們有 1,025 個站點配備了 SmartAssist，美國有 257 個站點配備了 Impella Connect，自 3 月以來，連接帳戶的數量增加了一倍多。此外，402 個站點已經在控制台上安裝了硬件，我們只需要醫院 WiFi 權限即可啟動 Impella Connect 帳戶。

Impella Connect allows Abiomed personnel to monitor the Impella console in the cloud and interact with the medical providers remotely on topics such as hemodynamics, alarm management and weaning capabilities.

Impella Connect 讓 Abiomed 人員在雲端監控 Impella 控制台，並與醫療服務提供者就血流動力學、警報管理和離線功能等主題進行遠端互動。

Our transition to Abiomed 2.0 encompasses online everything or moving a large portion of business activities to an online connected format. That includes management reviews, customer service and virtual training and education for customers and employees. An example of Abiomed 2.0 execution in Q1 was our team's ability to stay connected with doctors and customers throughout the pandemic, providing education and training virtually. Within the quarter, we reached roughly 950 doctors through online professional education and training. Additionally, on a weekly basis, we connected with anywhere from 60 to 150-plus cardiologists and cardiac surgeons to identify lessons learned in treating patients with cardiogenic shock, myocarditis, COVID-19 and organ failure. We have been reviewing and collecting specific case studies on Impella and ECMO support for patients with and without COVID-19.

我們向 Abiomed 2.0 的過渡包括一切在線或將大部分業務活動轉移到線上連接格式。這包括管理審查、客戶服務以及針對客戶和員工的虛擬培訓和教育。第一季 Abiomed 2.0 執行的一個例子是我們的團隊能夠在整個大流行期間與醫生和客戶保持聯繫，提供虛擬教育和培訓。在本季度內，我們透過線上專業教育和培訓接觸了大約 950 名醫生。此外，我們每週都會與 60 至 150 多名心臟病專家和心臟外科醫生聯繫，以總結治療心因性休克、心肌炎、COVID-19 和器官衰竭患者的經驗教訓。我們一直在審查和收集有關 Impella 和 ECMO 對患有和未患有 COVID-19 患者的支持的具體案例研究。

As a result of our ability to adapt and track data in our clinical databases, we were able to receive FDA Emergency Use Authorization for ECPELLA this week, which further validates the unloading benefit of Impella with ECMO support for patients in shock requiring oxygenation.

由於我們能夠調整和追蹤臨床資料庫中的數據，我們本週獲得了 FDA 對 ECPELLA 的緊急使用授權，這進一步驗證了具有 ECMO 支持的 Impella 對於需要氧合的休克患者的卸載益處。

Another important 2.0 milestone was the launch of CAMP PCI, our largest training and education initiative in company history. We recruited an esteemed faculty of physicians, launched a cutting-edge platform and held a successful virtual users meeting on June 5, attended by physicians from the United States and Europe. CAMP PCI leverages advanced digital content, such as live virtual weekly cases and proctorships from world-renowned interventional cardiologists. We remain focused on establishing CAMP PCI and the user group as the best online in interactive education and training resource in cardiology.

另一個重要的 2.0 里程碑是 CAMP PCI 的推出，這是我們公司歷史上最大的培訓和教育計劃。我們招募了一群受人尊敬的醫生，推出了一個尖端平台，並於 6 月 5 日成功舉辦了一次虛擬用戶會議，來自美國和歐洲的醫生參加了會議。 CAMP PCI 利用先進的數位內容，例如每週即時虛擬病例和世界知名介入性心臟病專家的指導。我們仍然致力於將 CAMP PCI 和用戶群打造為心臟病學領域最佳的線上互動教育和培訓資源。

Moving on to product pipeline. In May, we shifted to the full market release of Impella 5.5 with SmartAssist and our expanded surgical organization. At the end of the quarter, the Impella 5.5 was in 86 U.S. sites and more than half are online with Impella Connect. We will continue to launch this 5.5 product with a goal of nearly 100% of the consoles on Impella by the year-end.

轉向產品管道。 5 月份，我們轉向全面市場發布帶有 SmartAssist 的 Impella 5.5 以及我們擴大的手術組織。截至本季末，Impella 5.5 已在 86 個美國網站上使用，其中超過一半透過 Impella Connect 線上使用。我們將繼續推出這款 5.5 產品，目標是在年底前覆蓋 Impella 上近 100% 的遊戲機。

Clinical data on the first 55 patients treated with the Impella 5.5 with SmartAssist published in the July edition of the American Society of Artificial Internal Organs, or ASAIO, found 84% of patients survived to explant with 76% of survivors having native heart recovery, which is impressive for chronic heart failure patients. It is exciting to see real-world data demonstrating improved survival rates and the benefit of 5.5 unloading for acutely decompensating heart failure patients in cardiogenic shock.

美國人工內臟器官協會(ASAIO) 7 月版上發表了首批55 名使用Impella 5.5 和SmartAssist 治療的患者的臨床數據，發現84% 的患者在移植後存活下來，其中76% 的倖存者心臟恢復正常，這對於慢性心臟衰竭患者來說令人印象深刻。令人興奮的是，現實世界的數據表明，5.5 減負荷對心因性休克急性失代償性心臟衰竭患者的生存率有所提高，並且具有益處。

Now turning to the regulatory progress. On May 29, we received FDA Emergency Use Authorization for Impella RP to treat COVID-19 patients with right heart failure from pulmonary embolism. Since the onset of the pandemic, the Impella RP has become a therapeutic choice for clinicians treating certain COVID-19 patients suffering right heart failure. This EUA further validates the value of this life-saving product for those patients. On May 30, we received FDA approval for the Impella ECP early feasibility study in the U.S. The prospective multicenter, nonrandomized early feasibility study will allow Abiomed, the study investigators and the FDA to test the device in the U.S. and assess safety and feasibility in high-risk PCI patients. We look forward to beginning enrollment later this calendar year.

現在轉向監管進展。 5 月 29 日，我們獲得了 FDA 對 Impella RP 的緊急使用授權，用於治療因肺栓塞導致右心衰竭的 COVID-19 患者。自大流行爆發以來，Impella RP 已成為治療某些患有右心衰竭的 COVID-19 患者的臨床醫生的治療選擇。此 EUA 進一步驗證了這款救生產品對這些患者的價值。 5 月30 日，我們獲得FDA 批准在美國進行Impella ECP 早期可行性研究。這項前瞻性多中心、非隨機早期可行性研究將使Abiomed、研究人員和FDA 能夠在美國測試該設備，並評估高風險環境下的安全性和可行性。- 有 PCI 風險的患者。我們期待在今年晚些時候開始招生。

Moving on to Q2. We have transitioned to our yellow phase, and our manufacturing facilities in Aachen, Germany and Danvers, Massachusetts are moving back to full production. During this phase, we have begun to see the return of cardiogenic shock protocols and protected PCI procedures in most hospitals and geographies. With that said, we have seen a resurgence in COVID cases in certain areas across the globe and in the U.S., which may impact patient access and treatment. Overall, we believe hospitals are better prepared to handle the resurgence of COVID-19 patients currently due to the availability of testing and more preventative and safety measures in place versus the peak in April.

繼續第二季。我們已經過渡到黃色階段，我們位於德國亞琛和馬薩諸塞州丹佛斯的製造工廠正在恢復全面生產。在此階段，我們開始在大多數醫院和地區看到心臟休克方案和受保護的 PCI 程序的回歸。儘管如此，我們看到全球某些地區和美國的新冠病例再次出現，這可能會影響患者的就診和治療。總體而言，我們認為，由於檢測的可用性以及與 4 月高峰期相比採取的更多預防和安全措施，醫院目前已做好更充分的準備來應對 COVID-19 患者的復發。

In addition, physician societies, hospitals and government agencies are communicating and publishing guidelines on the management of patients with cardiovascular risk factors. These heart failure patients with or without COVID-19 are essential, high risk, emergent and at risk of death, if not treated in a timely manner. Extensive guidelines and physician statements have been published by U.S. and European societies as well as CMS and other government agencies around the globe. For example, a paper recently published in JACC summarizes guidance from 15 North American cardiovascular societies on the safe reintroduction of cardiovascular services during the COVID-19 pandemic. As a result, hospital systems are providing more timely and improved care for high-risk emergency cardiovascular heart failure patients. Abiomed will continue to provide 24/7 support on site, on call and online, while working to improve outcomes for the growing epidemic and increasing mortality of heart failure from coronary artery disease, obesity, type 2 diabetes, myocarditis and now COVID-19.

此外，醫師協會、醫院和政府機構正在溝通和發布有關心血管危險因子患者管理的指南。這些患有或不患有COVID-19的心臟衰竭患者都是急需、高風險、緊急的，如果不及時治療，就有死亡風險。美國和歐洲學會以及 CMS 和全球其他政府機構已發布了廣泛的指南和醫生聲明。例如，最近發表在 JACC 上的一篇論文總結了 15 個北美心血管學會關於在 COVID-19 大流行期間安全重新引入心血管服務的指導。因此，醫院系統正在為高危診心血管心臟衰竭患者提供更及時、更好的照護。 Abiomed 將繼續提供24/7 現場、隨叫隨到和線上支持，同時努力改善因冠狀動脈疾病、肥胖、2 型糖尿病、心肌炎和現在的COVID-19 導致的心臟衰竭日益流行和死亡率上升的結果。

The U.S. population 65-plus years of age is increasing 44% by 2030 and per a JAMA study, mortality is also increasing for both the 65 plus and the 45- to 65-year-old populations. No other company in med tech is focused on the science and therapy of unloading the heart and recovering the myocardium.

到 2030 年，美國 65 歲以上人口將增加 44%，根據 JAMA 的一項研究，65 歲以上和 45 至 65 歲人口的死亡率也在增加。醫療技術領域沒有其他公司專注於減輕心臟負荷和恢復心肌的科學和治療。

With our Breethe acquisition, we are now uniquely positioned to address, in the future, respiratory failure and combination heart and lung therapy with ECPELLA as well. I would like to share a story about one of our recent patients, [Devon Smith], a 42-year-old warehouse worker from Pennsylvania. He began experiencing flu-like symptoms, muscle aches and difficulty breathing. Devon was transported by ambulance to Mercy Fitzgerald Hospital in Darby, PA, where he was diagnosed with COVID-19, multi-organ failure, severe myocarditis and respiratory failure. With his ejection fraction dangerously low at 5%, interventional cardiologist, Dr. John Finley inserted the Impella CP to allow Devon's heart to rest and recover. Physicians also placed venous arterial or VA-ECMO to combat the respiratory effects of COVID-19.

透過收購 Breethe，我們現在處於獨特的地位，可以在未來解決呼吸衰竭以及使用 ECPELLA 進行心肺聯合治療。我想分享一個關於我們最近的一位患者的故事，他是來自賓夕法尼亞州的 42 歲倉庫工人 [Devon Smith]。他開始出現類似流感的症狀、肌肉疼痛和呼吸困難。 Devon 被救護車送往賓州達比的 Mercy Fitzgerald 醫院，在那裡他被診斷出患有 COVID-19、多重器官衰竭、嚴重心肌炎和呼吸衰竭。由於射血分數低至 5%，非常危險，介入心臟科醫生 John Finley 博士為 Devon 植入了 Impella CP，讓他的心臟休息和恢復。醫生也放置靜脈動脈或 VA-ECMO 來對抗 COVID-19 對呼吸系統的影響。

Shortly after Devon was transferred to the hospital of the University of Pennsylvania and Philadelphia. After 4 days on Impella CP and ECMO support called ECPELLA, Devon's heart showed dramatic improvement and the Impella and ECMO devices were weaned and explanted. Devon returned home after 3 weeks in the hospital with his native heart functioning normally at 60% to 65% EF. He is now back at work and looks forward to spending more time with family and working on his car. This remarkable story represents great care, a life saved and one of the most cost-effective treatments in health care because it eliminates some of the most expensive and invasive surgeries costing over $0.5 million in hospital charges within 6 months. These lower costs with quality of life helped both the patient and the insurance provider, which was Blue Cross Blue Shield.

不久後，德文郡被轉移到賓州大學和費城大學的醫院。使用 Impella CP 和稱為 ECPELLA 的 ECMO 支援 4 天后，Devon 的心臟出現了顯著改善，Impella 和 ECMO 設備被停用並移植。 Devon 住院 3 週後返回家中，其心臟功能正常，EF 為 60% 至 65%。他現在已經回到工作崗位，並期待花更多的時間與家人在一起並修理他的汽車。這個非凡的故事代表了極大的護理，拯救了生命，也是醫療保健中最具成本效益的治療方法之一，因為它在6 個月內消除了一些最昂貴和侵入性的手術，醫院費用超過50 萬美元。這些較低的成本和生活品質對病人和保險公司（即 Blue Cross Blue Shield）都有幫助。

Now looking towards the remainder of fiscal '21. We are focused on our goals as we rebuild Abiomed 2.0. We continue to invest in advanced pipeline technologies including the XR Sheath, Impella ECP, Impella Connect, Impella BTR and new AI algorithms. We remain on track to bring the XR Sheath, an expandable and recordable sheath, that allows for a 9 Fr closure device to the market with Impella 2.5 through a limited market release in our fiscal Q3.

現在展望 21 財年的剩餘時間。在重建 Abiomed 2.0 時，我們專注於我們的目標。我們繼續投資先進的管道技術，包括 XR Sheath、Impella ECP、Impella Connect、Impella BTR 和新的 AI 演算法。我們仍然致力於將 XR 護套（一種可擴展且可記錄的護套）透過我們第三財季的有限市場發布，與 Impella 2.5 一起將 9 Fr 閉合裝置推向市場。

Our Breethe ECMO technology remains on track for a 510(k) clearance by the end of the fiscal year. We continue to drive an accelerated rollout of Impella Connect and recently received FDA approval for data streaming from the Impella Connect console, which means console data can be streamed live via Impella Connect to a HIPAA-compliant secure server, where AI will provide predictive clinical information to physicians in the future.

我們的 Breethe ECMO 技術仍有望在本財政年度結束時獲得 510(k) 批准。我們繼續推動Impella Connect 的加速推出，最近獲得FDA 批准從Impella Connect 控制台進行資料流傳輸，這意味著控制台資料可以透過Impella Connect 即時串流傳輸到符合HIPAA 標準的安全伺服器，其中人工智慧將提供預測性臨床資訊給未來的醫師。

Turning to clinical data. We began reenrolling patients in our STEMI DTU randomized controlled trial in July. We have recently enrolled 5 patients and reactivated 5 sites, totaling 21 patients at 13 hospitals to date. We continue to advance the PROTECT IV RCT study and physician recruitment for the steering committee has been completed. In the fall, we are planning to release and publish the final data from PROTECT III, which will total over 1,000 patients. The favorable interim report on 898 patients was presented at late-breaking science at TCT in September 2019 last year. PROTECT III is the ongoing prospective single-arm FDA post-approval study for the PMA approval of Impella 2.5 and Impella CP in high-risk PCI. The PROTECT series of studies now represents the largest and most comprehensive study of approximately 1,500 patients treated for high-risk PCI with clinical data reviewed by the FDA from years 2006 to present. Overall, we expect to have multiple meaningful publications this fiscal year.

轉向臨床數據。我們於 7 月開始在 STEMI DTU 隨機對照試驗中重新招募患者。我們最近招募了 5 名患者，並重新啟動了 5 個站點，迄今為止，共有 13 家醫院的 21 名患者。我們繼續推進 PROTECT IV RCT 研究，指導委員會的醫生招募工作已經完成。今年秋天，我們計劃發布並公佈 PROTECT III 的最終數據，總計將超過 1,000 名患者。去年 2019 年 9 月，TCT 的最新科學成果發表了這份針對 898 名患者的有利中期報告。 PROTECT III 是一項正在進行的前瞻性單臂 FDA 批准後研究，旨在獲得 PMA 批准 Impella 2.5 和 Impella CP 用於高風險 PCI。 PROTECT 系列研究目前是規模最大、最全面的研究，涉及約 1,500 名接受高風險 PCI 治療的患者，其臨床數據由 FDA 從 2006 年至今進行審查。整體而言，我們預計本財年將發布多份有意義的出版品。

Before I conclude, I want to highlight and recognize the positive real-world interim data on 819 Japanese patients from a multicenter prospective study conducted by the council for the clinical use of ventricle assist device related academic societies and the PMDA in Japan. The study conducted at 109 hospitals with oversight by 10 Japanese professional societies found that the use of Impella was associated with a 77% survival rate at 30 days in AMI, cardiogenic shock patients. Other findings from the study included that the Impella therapy is highly effective treatment for myocarditis with an 88% survival rate at 30 days. The study's findings about the use of best practices are consistent with other published and investigator-led studies, such as the National Cardiogenic Shock Initiative study and the Inova Shock study that have demonstrated significant increases in survival with the use of Impella best practice protocols compared to the historical survival rate for cardiogenic shock at 50%.

在結束之前，我想強調並認可日本心室輔助裝置臨床使用委員會和日本 PMDA 進行的一項多中心前瞻性研究中關於 819 名日本患者的積極的真實中期數據。這項由 10 個日本專業協會監督的研究在 109 家醫院進行，發現使用 Impella 可使 AMI 心因性休克患者 30 天的存活率達到 77%。研究的其他發現包括，Impella 療法是治療心肌炎的高效方法，30 天存活率為 88%。該研究關於使用最佳實踐的結果與其他已發表的和研究者主導的研究一致，例如國家心臟休克倡議研究和Inova 休克研究，這些研究表明，與使用Impella 最佳實踐方案相比，使用Impella 最佳實踐方案可顯著提高存活率。心因性休克的歷史存活率為 50%。

In conclusion, I'm proud of Abiomed's execution, delivering on our Q1 red phase commitments and maintaining our focus to recover hearts and save lives. We supported each other, our customers and our patients. We achieved sequential improvements in revenue and patients, strengthened our clinical data and advanced our pipeline technology. Our operational accomplishments in Q1 span the global organization and position our company for success for many years to come.

總而言之，我對 Abiomed 的執行力感到自豪，它兌現了我們第一季紅色階段的承諾，並繼續專注於恢復心臟和拯救生命。我們互相支持，我們的客戶和患者也互相支持。我們在收入和患者方面實現了連續改善，加強了我們的臨床數據並推進了我們的管道技術。我們第一季的營運成就涵蓋了全球組織，並為我們公司在未來多年的成功奠定了基礎。

As we progress through the Q2 yellow phase, we know that we must remain focused and adapt to the ever-changing environment with speed in execution. Again, I would like to express my deepest appreciation for our teams across the company and for our customers. I would also like to thank our shareholders for their continued support. We will make fiscal '21 one of the most productive and transformative years for the company, as we build Abiomed 2.0 and continue to innovate products that are smaller, smarter and more connected, while we pursue studies for Class I guidelines.

當我們進入第二季的黃色階段時，我們知道我們必須保持專注並快速執行以適應不斷變化的環境。我想再次對整個公司的團隊和我們的客戶表達最深切的謝意。我還要感謝我們的股東一直以來的支持。我們將把 21 財年打造成公司最俱生產力和變革性的一年，我們將打造 Abiomed 2.0，並繼續創新更小、更聰明、更互聯的產品，同時繼續研究 I 類指南。

I will now turn the call over to Todd.

我現在將把電話轉給托德。

Thank you, Mike, and thanks, everyone, for joining the call today. I hope you and your families are staying safe. During our last quarter call, we talked about the actions we were taking to be prepared for the dynamics of the COVID-19 environment. Those preparations served us well, and as Mike described, we're navigating the near-term challenges, while keeping a focus on the long term.

謝謝麥克，也謝謝大家今天加入電話會議。我希望您和您的家人保持安全。在上個季度的電話會議中，我們討論了我們為應對 COVID-19 環境動態而採取的行動。這些準備工作對我們很有幫助，正如麥克所描述的，我們正在應對近期挑戰，同時專注於長期目標。

The negative effects of the pandemic resulted in Q1 revenue of $165 million, down 21% versus prior year. We felt the impact of the environment most intensely in April in terms of the decline in patients and revenue from the shelter-in-place restrictions and limitations on hospital procedures in most countries.

疫情的負面影響導致第一季營收為 1.65 億美元，比去年同期下降 21%。我們在四月感受到環境的影響最強烈，因為大多數國家的就地避難限制和醫院程序限制導致病患數量和收入下降。

As Mike mentioned, we saw sequential improvement globally in May and June as restrictions were lifted and limitations eased. In the month of June specifically, we delivered year-over-year global revenue growth of 4%, driven by growth in both patients and revenue in the U.S., Europe and Japan.

正如麥克所提到的，隨著限制的取消和限制的放鬆，我們在 5 月和 6 月看到全球範圍內的連續改善。具體來說，在 6 月份，在美國、歐洲和日本的患者數量和收入成長的推動下，我們的全球收入年增了 4%。

We believe we experienced some positive lift in June, as some patients, who had deferred treatment in April and May began to come back into the system. For your reference, we have provided a slide in our investor package, Slide 3, which breaks out reported revenue and patient performance by month and by geography.

我們相信，我們在 6 月經歷了一些積極的提升，因為一些在 4 月和 5 月推遲治療的患者開始回到系統中。為了供您參考，我們在投資者包中提供了一張幻燈片，即幻燈片 3，其中按月份和地理位置細分了報告的收入和患者表現。

In the U.S., we delivered revenue of $135 million, down 23% year-over-year, driven by a 22% decline in patient utilization. The Northeast in California declined the most from an otherwise broad-based decline in utilization in the quarter. U.S. revenue grew 3% in the month of June. In the U.S., at the end of June, the Impella 2.5 and CP have reached 1,451 sites. The Impella 5.0 has been placed in 653 sites and the RP is in 538 sites.

在美國，由於患者利用率下降 22%，我們的收入為 1.35 億美元，年減 23%。加州東北部地區的下降幅度最大，本季利用率普遍下降。美國 6 月份營收成長 3%。在美國，截至 6 月底，Impella 2.5 和 CP 已達到 1,451 個站點。 Impella 5.0已部署在653個站點，RP部署在538個站點。

The Impella 5.5 with SmartAssist is now in 86 sites. We continue to receive very positive feedback from the surgeons on this innovative technology as well as positive real-world clinical data on outcomes.

配備 SmartAssist 的 Impella 5.5 現已遍佈 86 個站點。我們繼續收到外科醫生對這項創新技術的非常積極的反饋以及關於結果的積極的現實臨床數據。

In the quarter, the reorder rate was just shy of 100%. Average combined inventory at the hospitals for the Impella 2.5 and CP was approximately 4.6 units per site, basically in line with the inventory levels we saw last quarter.

本季，再訂購率略低於 100%。醫院每個地點的 Impella 2.5 和 CP 平均合併庫存約為 4.6 台，基本上與我們上季度看到的庫存水準一致。

Outside the U.S., revenue totaled $30 million, down 6% on constant currency due to the negative impact of COVID-19 across all regions. Our European revenue decreased 10% on constant currency, driven by weakness in Germany, France and the Benelux region. Specifically, German revenue was down 9% in the quarter, driven by softness in high-risk PCI. For the month of June, revenue in Germany and Europe was flat and up 5%, respectively, on a year-over-year basis.

由於 COVID-19 對所有地區的負面影響，美國以外地區的收入總計 3,000 萬美元，以固定匯率計算下降 6%。由於德國、法國和比荷盧地區經濟疲軟，我們的歐洲收入以固定匯率計算下降了 10%。具體而言，由於高風險 PCI 疲軟，德國本季營收下降 9%。 6 月份，德國和歐洲的營收較去年同期持平，分別成長 5%。

In Japan, we delivered $9 million in revenue in Q1, up 3% on constant currency due to the impact of COVID-19 and lower site openings. This quarter, we opened 13 new sites, 9 fewer than a year ago. As a reminder to investors, we front-loaded site openings in the first half of last year to allow the local team to focus on the post-approval study in a broader CP launch. Similar to other regions, Japan did see a recovery within the quarter as revenue in the month of June increased 22% year-over-year. Gross margin was 78.2% in the quarter compared to 82.1% in the prior year. The year-over-year variance was primarily driven by lower production volume and some incremental costs to accelerate the Impella Connect rollout.

在日本，由於 COVID-19 和網站開放率下降的影響，我們第一季實現了 900 萬美元的收入，按固定匯率計算增長了 3%。本季度，我們開設了 13 個新站點，比一年前減少了 9 個。提醒投資者，我們在去年上半年提前開放了場地，以便當地團隊能夠專注於更廣泛的 CP 啟動中的批准後研究。與其他地區類似，日本在本季確實出現了復甦，6 月的營收年增 22%。本季毛利率為 78.2%，而去年同期毛利率為 82.1%。同比差異主要是由於產量下降以及加速 Impella Connect 推出的一些增加成本所造成的。

As Mike mentioned, one of the objectives of the Q1 red phase was to continue to invest in innovation, while being fiscally responsible. In the first quarter, R&D expense totaled $26 million, an increase of 11% versus prior year. We invested in small-bore devices, specifically the XR Sheath and ECP and in clinical studies including STEMI DTU and PROTECT IV, to support our long-term sustainable growth.

正如麥克所提到的，第一季紅色階段的目標之一是繼續投資於創新，同時承擔財政責任。第一季研發費用總計2,600萬美元，較去年同期成長11%。我們投資了小口徑設備，特別是 XR Sheath 和 ECP，以及包括 STEMI DTU 和 PROTECT IV 在內的臨床研究，以支持我們的長期永續成長。

SG&A expenses for the first quarter totaled $68 million, down 21% versus prior year. The variance was driven by our emphasis on lower discretionary expenses, executive and management salary reductions, reduced work schedules and lower stock-based compensation in the quarter. Q1 operating income was $34 million, translating to an operating margin of 20.7% versus 29.2% in the prior year. The year-over-year margin performance was primarily driven by lower volume and our ongoing growth investments despite the favorable impact of the cost actions we implemented.

第一季的 SG&A 支出總計 6,800 萬美元，比去年同期下降 21%。造成差異的原因是我們強調本季降低可自由支配費用、高階主管和管理階層減薪、減少工作安排以及降低股票薪資。第一季營業收入為 3,400 萬美元，營業利潤率為 20.7%，而去年同期為 29.2%。儘管我們實施的成本行動產生了有利影響，但同比利潤率表現主要是由銷售下降和我們持續的成長投資所推動的。

GAAP net income for Q1 was $45 million or $0.98 per diluted share versus $1.93 in Q1 FY '20. The year-over-year performance was driven by lower volume, a mark-to-market adjustment on our Shockwave investment and our tax rate. In Q1, our reported tax rate was 27% versus 14% in the prior year, driven by lower excess tax benefits associated with equity compensation.

第一季的 GAAP 淨利潤為 4,500 萬美元，即稀釋後每股收益 0.98 美元，而 20 財年第一季的 GAAP 淨利潤為 1.93 美元。年比業績的推動因素包括銷售下降、Shockwave 投資的按市價調整和稅率。第一季度，我們報告的稅率為 27%，而前一年為 14%，這是由於與股權薪酬相關的超額稅收優惠減少所致。

Our balance sheet remains very strong. We generated $32 million of operating cash flow in the quarter, and we ended June with a cash balance of nearly $600 million, up 13% over last year with no debt. Our cash balance declined versus fiscal year-end due to the Breethe acquisition. We continue to be disciplined and have the capital necessary to stay focused on innovation in the long term.

我們的資產負債表仍然非常強勁。本季我們產生了 3,200 萬美元的營運現金流，截至 6 月份，我們的現金餘額接近 6 億美元，比去年增長 13%，沒有債務。由於收購 Breethe，我們的現金餘額較財年末下降。我們持續遵守紀律，並擁有長期專注於創新所需的資本。

The COVID pandemic is still very fluid and continues to evolve differently across geographies. We believe we are likely to continue to experience variable impacts on our business based on some of the resurgence that is occurring in cities across the globe. Given the uncertainty in the environment and consistent with our comments last quarter, we're not in position to provide full year guidance at this time. However, to provide transparency to our investors during this period of COVID resurgence, we will provide insight into our July preliminary results.

新冠病毒大流行仍然非常不穩定，並且在不同地區繼續以不同的方式發展。我們相信，由於全球城市中出現的一些復甦，我們的業務可能會繼續受到不同的影響。鑑於環境的不確定性，並且與我們上季度的評論一致，我們目前無法提供全年指引。然而，為了在新冠疫情捲土重來期間向投資者提供透明度，我們將提供有關 7 月初步結果的見解。

For the month of July, we reported approximately 8% global revenue growth year-over-year, potentially augmented by timing of reorders, favorable sales mix and foreign exchange. However, U.S. patient utilization for the month of July was down approximately 4% year-over-year, driven by a resurgent in COVID cases across select areas, such as Florida, Texas and California. Japan has also seen a resurgence in COVID cases, which is impacting utilization, resulting in single-digit patient growth for the month.

7 月份，我們報告全球收入年增約 8%，這可能會因重新訂購的時機、有利的銷售組合和外匯而增加。然而，由於佛羅裡達州、德克薩斯州和加利福尼亞州等特定地區的新冠病例復甦，美國 7 月的患者利用率比去年同期下降了約 4%。日本的新冠病例也出現回升，影響了利用率，導致本月患者數量出現個位數成長。

Abiomed has a benefit of patient visibility by hospital, by physician and by indication through our on-site, on-call and online tracking included in our IQ database and Impella Connect platform. We will continue to monitor the fluid situation and will provide updates as necessary.

Abiomed 的優勢在於，透過我們的 IQ 資料庫和 Impella Connect 平台中包含的現場、隨叫隨到和線上跟踪，可以按醫院、醫生和指示顯示患者的可見性。我們將繼續監控流體情況，並根據需要提供最新資訊。

In conclusion, while Q1 was a challenging quarter, we are very pleased with our operational performance and our sequential improvement in both revenue and patients as we transition to the Q2 yellow phase. We still face short-term uncertainties given the depth and unknown duration of the pandemic, and we are focused on the actions we can take and what we can control. We will continue to be agile, which allows us to adapt and execute quickly and remain focused on our fiscal year '21 goals. We are confident in our overall strategy in the significant opportunities ahead for Abiomed.

總而言之，雖然第一季是一個充滿挑戰的季度，但隨著我們過渡到第二季度黃色階段，我們對我們的營運業績以及收入和患者方面的連續改善感到非常滿意。鑑於疫情的深度和持續時間未知，我們仍然面臨短期不確定性，我們關注的是我們可以採取的行動和我們可以控制的事情。我們將繼續保持敏捷性，這使我們能夠快速適應和執行，並繼續專注於我們的 21 財年目標。我們對 Abiomed 未來的重大機會的整體策略充滿信心。

With that, 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 Raj Denhoy from Jefferies.

（操作員說明）我們的第一個問題來自 Jefferies 的 Raj Denhoy。

Wonder if maybe I could start with some additional detail perhaps on June and July. I'm curious if there's anything you can provide in terms of whether there was some deferral catch-up that maybe drove the better performance in June. And then maybe as you're getting into July, that's more of a normalized demand. Is there anything you can offer just in terms of the complexion of maybe patients coming back that were previously not done? And how that maybe impacts the growth going forward?

想知道我是否可以在六月和七月開始提供一些額外的細節。我很好奇您是否可以提供任何資訊來說明是否有一些延期追趕可能推動了 6 月份更好的表現。也許隨著進入七月，這更像是一種正常化的需求。對於可能回來的患者的膚色，您是否可以提供一些以前沒有做過的東西？這可能如何影響未來的成長？

Yes, Raj, it's a good question. So in terms of June, obviously, part of it was driven from some of the, what I'd say, reorder rates that were a little bit lower in April and May as hospitals kind of managed inventory. So we saw our reorder rates fairly low in those months, and there was a little bit of a catch-up, I would say, in the month of June. With that said, I mean, our patient growth in June was up 7% in the United States versus 3% from a revenue standpoint. As I think about July, a couple of things I'd point out. First, it's 1 month, right? And I don't think you can translate the performance to the entire quarter. As I mentioned, we had a really strong finish to June, and some of those reorders did push into July. One thing we are seeing is we are seeing a favorable sales mix as the 2.5 is really being replaced by the CP and the 5.0 is being replaced by the 5.5. So we've seen some benefits of higher average selling prices there.

是的，拉傑，這是個好問題。因此，就 6 月而言，顯然，部分原因是由於醫院對庫存進行了管理，四月和五月的再訂購率略低。因此，我們看到那幾個月的再訂購率相當低，而且我想說，六月有一點追趕。話雖如此，我的意思是，我們 6 月在美國的患者成長了 7%，而從收入的角度來看，成長了 3%。當我想到七月時，我想指出一些事情。首先，是1個月吧？我認為你無法將業績轉化為整個季度。正如我所提到的，我們在 6 月的收尾表現非常強勁，其中一些重新訂購確實延續到了 7 月。我們看到的一件事是，我們看到了有利的銷售組合，因為 2.5 確實被 CP 取代，5.0 也被 5.5 取代。因此，我們已經看到了較高平均售價的一些好處。

We saw a little bit more 5.5 deals as well in the month of July. And the FX rate too, is a little bit of a -- I would say, a little bit of a tailwind. The Euro rate was $1.18 in July this year versus the $1.12 last year. So there's a little bit of noise, I would say, in the month of July. But overall, it's 1 month. We still have a long way to go. And the only other thing I'd point out about July and Q2 is, we did have a really strong September, and I just want to make sure people understand that we had some tough comps in the latter half of the year. September's growth rate was about 25%. So just, I would say, don't get ahead of us a little bit in the month of July.

7 月我們還看到了 5.5 筆交易。外匯匯率也有點——我想說，有點順風順水。今年 7 月歐元匯率為 1.18 美元，去年為 1.12 美元。所以我想說，七月有一些噪音。但總的來說，也就1個月。我們還有很長的路要走。關於 7 月和第二季度，我要指出的唯一一件事是，我們確實度過了一個非常強勁的 9 月，我只是想確保人們明白我們在下半年有一些艱難的比較。 9月份的成長率約為25%。所以，我想說的是，在 7 月不要領先我們一點點。

Understood. And maybe just one last one in terms of the complexion of revenues. It looked like shock was still down maybe high teens. PCI was down maybe twice that rate. The question is risen about why shock is not coming back? Why there's still such a falloff in that kind of very emergent kind of need to treat indication? And so anything you can offer in terms of whether you're seeing any disparate kind of rebound in that versus PCI as we're going forward?

明白了。就收入的複雜性而言，也許只是最後一項。看起來震驚仍然在十幾歲左右。 PCI 的下降率可能是這個速度的兩倍。問題是為什麼休克沒有回來？為什麼這種非常緊急的治療適應症的需求仍然如此減少？那麼，在我們前進的過程中，您是否看到了與 PCI 不同類型的反彈，您能提供什麼資訊嗎？

Yes, Raj. I can tell you, for the quarter, high-risk PCI was down 35% and shock was down 12%. But as you look at how it progressed through the quarter, for the month of June, actually, shock was up almost double digits and high-risk PCI was basically flattish. So we definitely saw a stronger recovery in both indications, but a little bit stronger on the shock side and an increase in RP.

是的，拉傑。我可以告訴你，本季度，高風險 PCI 下降了 35%，衝擊下降了 12%。但當你看看整個季度的進展時，實際上，6 月的衝擊幾乎上升了兩位數，而高風險 PCI 基本上持平。因此，我們確實看到這兩個指標都出現了更強勁的復甦，但在衝擊方面和 RP 方面有所增強。

Our next question comes from Margaret Kaczor from William Blair.

我們的下一個問題來自威廉·布萊爾的瑪格麗特·卡佐爾。

Just wanted to follow up again on the July commentary. We were (inaudible) recently who also saw some maybe delays in July, but they suggested that maybe some of those were just truly delays and already getting rescheduled for the next couple of weeks. So I was curious if you guys are seeing that as well? Or is it too early to tell?

只是想再跟進七月的評論。我們（聽不清楚）最近在 7 月也看到了一些可能的延誤，但他們表示，也許其中一些只是真正的延誤，並且已經在接下來的幾週內重新安排了時間。所以我很好奇你們是否也看到了這一點？還是現在說還太早？

So Margaret, I want to make sure I clarify the question. The -- is it about a rebound in July from some of the delays?

瑪格麗特，我想確保我澄清了這個問題。這是關於 7 月從一些延誤中反彈的情況嗎？

Yes, correct. And the timing of rescheduling some of those cases.

是，對的。以及重新安排其中一些案件的時間。

Sure. So obviously, a few of our patients are getting CPR. And in April, when systems were really overwhelmed, for example, in New York City and in Italy, basic treatment for cardiovascular diseases was pretty much on hold, unfortunately. However, what we did see is, as things progressed, we saw a strong rebound in Italy and New York City and had positive months in patients in both May and June in those areas. As I mentioned in my prepared remarks, the societies in Europe, in the U.S. and even the government agencies like CMS are now putting out guidance documents because cardiovascular patients that are high risk or urgent or emergent have high risk of death if they are not treated in a timely manner. So they're doing a much better job. And so we feel confident that the system won't get broken again or overwhelmed and what we see is that as things progress, they're able to rebound, they're able to still treat those emergency patients because again, they have an imminent risk.

當然。顯然，我們的一些患者正在接受心肺復甦術。不幸的是，四月份，當系統確實不堪重負時，例如在紐約市和義大利，心血管疾病的基本治療幾乎被擱置。然而，我們確實看到的是，隨著事情的進展，我們看到義大利和紐約市出現強勁反彈，而這些地區的患者在 5 月和 6 月都出現了積極的幾個月。正如我在準備好的演講中提到的，歐洲、美國的協會，甚至像CMS 這樣的政府機構現在都在發布指導文件，因為高風險或緊急或緊急的心血管患者如果不接受治療，死亡風險很高。及時。所以他們做得更好。因此，我們相信系統不會再次崩潰或不堪重負，我們看到的是，隨著事情的進展，他們能夠反彈，他們仍然能夠治療那些緊急患者，因為他們再次面臨迫在眉睫的緊急情況風險。

And in some cases, they have a higher risk of death than some COVID patients when they're in profound organ failure. So that's the trend we've been seeing. It's -- we're optimistic about it. However, there are some places that have been a little bit overwhelmed in the ICU. We're able to track that and those areas where we don't get as much interaction into the hospital, having the Impella Connect and having the telesales or the clinical team there calling in, helping on cases is very productive as well.

在某些情況下，當他們患有嚴重器官衰竭時，他們的死亡風險比一些新冠患者更高。這就是我們所看到的趨勢。我們對此持樂觀態度。不過，ICU裡有些地方已經有點不堪負荷了。我們能夠追蹤這一點以及那些我們與醫院互動較少的區域，透過 Impella Connect 並讓電話銷售或臨床團隊打電話過來，幫助處理病例也非常有效率。

Okay. Yes. That's helpful. And then I wanted to clarify that you -- I think you had referenced your now in the yellow phase. What are the changes that you're making commercially as you're in this phase? And should we assume that there is a potential for growth? Or is comps going to -- or comps going to impact that a bit?

好的。是的。這很有幫助。然後我想澄清一下，我想你已經提到了你現在處於黃色階段。在此階段，您在商業上做出了哪些改變？我們是否應該假設存在成長潛力？或者比較會--或者比較會對此產生一點影響嗎？

It's a great question. And so as we look at the year, we're providing total transparency to our investors, you can see how we're managing and what we're seeing relative to both revenue and patients. The red phase was really driven by a bit of the unknown, and there was less preventative care. There was less documented guidelines, and we think we've managed through that pretty well. And we really truly invested in the innovation, things that we can control. As we move to the yellow phase, it has to do now with continuing to advance the product innovation, the regulatory approvals, ramping up again our clinical studies, moving forward on lots of publications and managing not just COVID logistics but the anxieties. And so the way we're doing that is, we're -- want to become experts at testing, whether for the antibodies or the active case. And so we're buying tests. We're performing tests.

這是一個很好的問題。因此，當我們回顧這一年時，我們向投資者提供完全的透明度，您可以看到我們的管理方式以及我們所看到的相對於收入和患者的情況。紅色階段確實是由一些未知因素驅動的，而且預防性護理也較少。記錄的指導方針較少，但我們認為我們已經很好地解決了這個問題。我們確實真正投資於創新，投資於我們可以控制的事情。當我們進入黃色階段時，現在需要繼續推動產品創新、監管審批、再次加強我們的臨床研究、推動大量出版物以及管理新冠物流和焦慮。所以我們這樣做的方式是，我們希望成為測試專家，無論是抗體還是活躍病例。所以我們正在購買測試。我們正在進行測試。

We have local accounts that we can send our people to. We run drills once a week, where we do a COVID mock drill where a person is identified to potentially have it. They run through the process. We clean out their cubical, their office, we sterilize it, and we ask them now to go and get tested, not the -- not that upper nasal test but some of these less invasive procedures that are lower nasal or saliva. We just want people to get used to that process because I think the anxiety is tougher than logistics. We've only had 15 cases globally. We haven't had any patients that have had death, and we only had one hospitalized briefly, but the person is doing fine now. So we've -- again, we want to make sure that we manage everything here in the office. We've never shut down in the office, but we had a skeleton crew for manufacturing and logistics. Now we're moving back to full production. And it's a bit business as usual.

我們有本地帳戶，可以將人員派遣到其中。我們每週進行一次演習，進行新冠病毒模擬演習，確定一個人可能患有該病毒。他們貫穿整個過程。我們清理他們的隔間，他們的辦公室，我們對其進行消毒，我們要求他們現在去接受測試，不是——不是上鼻測試，而是一些侵入性較小的下鼻或唾液測試。我們只是希望人們習慣這個過程，因為我認為焦慮比後勤更難。我們全球只有 15 例。我們沒有任何患者死亡，只有一名患者短暫住院，但他現在情況良好。因此，我們再次希望確保我們管理辦公室的一切。我們的辦公室從未關閉過，但我們擁有一支負責製造和物流的骨幹人員。現在我們正在恢復全面生產。這有點像往常一樣。

From a customer education and training perspective, they are used to now being on virtual calls. We do weekly live cases now. So every Wednesday, we have a live case with -- from a hospital, where physician panel experts and people call in. We record it for people to watch it later on CAMP PCI, but we've pretty much moved everything now into supporting virtual training, virtual education for both our customers and our employees. And we are confident that we have the right blend of what we can control, what we can influence around outcomes and what we can endure. And so we'll continue to endure the COVID-19, but again, our main focus is improving outcomes and growing patients and revenue year-over-year in Q2.

從客戶教育和培訓的角度來看，他們現在已經習慣了虛擬通話。我們現在每週都會做現場案例。因此，每週三，我們都會收到來自一家醫院的現場病例，醫生小組專家和人們會打電話過來。我們將其錄製下來，供人們稍後在CAMP PCI 上觀看，但我們現在幾乎已經將所有內容都轉移到支援虛擬為我們的客戶和員工提供培訓和虛擬教育。我們相信，我們能夠正確地整合我們可以控制的事物、我們可以影響結果的事情以及我們可以忍受的事情。因此，我們將繼續忍受 COVID-19 的影響，但我們的主要重點仍在第二季度改善治療結果以及逐年增加患者和收入。

Great. And if I can, one last one. Just the new data in Japan, obviously, spectacular -- the growth that you guys saw in June was spectacular. Notwithstanding any COVID spikes, how should we think about progression there? Whether it's commercially or revenue oriented or maybe some societal responses?

偉大的。如果可以的話，最後一張。顯然，日本的新數據非常引人注目——你們在六月看到的成長是驚人的。儘管新冠肺炎疫情激增，我們該如何看待疫情的進展？是否是商業或收入導向，或者可能是一些社會反應？

The Japan interim data is very positive. We're going to finish out the final study, but that was presented by the Chairman of the Japanese committee on ventricle assist device usage. We feel good that the Japanese physicians are implementing best practices. They tend to show a lot of rigor and discipline in their protocols. And we -- with the exception of some of the flare-ups in Japan, we again love the fact that the primary focus with the Japanese physicians is native heart recovery. And we're moving forward to get the Impella 5.5 in Japan as soon as we can.

日本中期數據非常樂觀。我們將完成最終研究，該研究是由日本心室輔助裝置使用委員會主席提出的。我們對日本醫生正在實施最佳實踐感到高興。他們往往在協議中表現出非常嚴格和紀律。除了日本的一些突發事件之外，我們再次喜歡這樣一個事實：日本醫生的主要關注點是本土心臟的恢復。我們正努力盡快在日本推出 Impella 5.5。

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。

A couple of questions. First, Todd, I wanted to circle back on the June-July commentary and July specifically. The delta between revenue and patients treated is wider than we tend to see from you guys. Can you give us a better sense for the impact you're seeing from mix? And then the catch-up in reorders make sense, but you really didn't report a decrease in inventory levels or reorder rates in 1Q. So how big of a catch-up do you really need to see there? Why didn't we see more of a dip in the quarter?

有幾個問題。首先，托德，我想回顧一下六月至七月的評論，特別是七月的評論。收入和接受治療的患者之間的差異比我們從你們那裡看到的差異更大。您能否讓我們更了解您從混音中看到的影響？再訂購量的追趕是有道理的，但您確實沒有報告第一季庫存水準或再訂購率的下降。那麼你真正需要看到多大的追趕呢？為什麼我們沒有看到本季出現更多下滑？

Yes. So Chris, it's a good question. The reorder rate actually for the month of -- for the quarter was about 0.98. And so we've been typically a little over 1.01, 1.02 in the past several quarters. So the reorder rate was a little bit slow. And again, as you look at how it progressed through the quarter, I mean, April and May, the reorder rates were down in the low 90s. And then there was a little bit of a catch-up in June. But from an overall quarter perspective, it was still below 100%. So when I look at July's performance, and let's just take the U.S., for example, we are seeing about, I would say, 2 to 3 -- probably 3 plus points just from a stronger reorder point. Again, a lot of the -- June was really strong. And so at the end of June, some of those reorders did push into July, and I would say that's probably driving 3 points of growth in the month of July.

是的。克里斯，這是一個很好的問題。該季度當月的實際再訂購率約為 0.98。因此，過去幾季我們的比率通常略高於 1.01、1.02。所以重新訂購速度有點慢。再說一次，當你看看整個季度的進展時，我的意思是，4 月和 5 月，再訂購率下降到 90 左右。然後六月出現了一些追趕。但從整體季度來看，仍低於100%。因此，當我看 7 月份的表現時，我們以美國為例，我想說，我們看到的是 2 到 3 點——可能是 3 個以上的點，只是來自更強勁的再訂購點。再說一遍，六月的很多時間都非常強勁。因此，在 6 月底，其中一些重新訂購確實延續到了 7 月份，我想說這可能會推動 7 月份的 3 個百分點的成長。

The other big point, as I mentioned, is the mix on our business. And so if you think about CP, CP was down 18% in the first quarter, 2.5 was down over 60%. And so we see a higher average selling price on the CP versus 2.5. So we're seeing some mix there as well as the acceleration of our 5.5 versus our 5.0 and that's driving obviously some mix, too. So I would say from a sales mix perspective, it's probably 2.5, 3 points as well in the month of July. And the other thing too which we're seeing is because of the Emergency Use Authorization that came out in early June, we are seeing some nice pickup in RP. And our RP actually has a higher average selling price and actually had some nice growth in the month of June and as we head into July.

正如我所提到的，另一個要點是我們業務的混合。因此，如果你考慮 CP，第一季 CP 下降了 18%，2.5 下降了 60% 以上。因此我們看到 CP 的平均售價高於 2.5。所以我們看到了一些混合，以及 5.5 與 5.0 的加速，這顯然也推動了一些混合。所以我想說，從銷售組合的角度來看，7 月也可能是 2.5、3 個百分點。我們看到的另一件事是由於 6 月初發布的緊急使用授權，我們看到 RP 出現了一些不錯的回升。我們的 RP 實際上有更高的平均售價，並且在 6 月和進入 7 月時實際上有一些不錯的增長。

That's helpful. I appreciate all the detail there. And then, Mike, it basically sounds like we've transitioned directly to the green phase that you laid out in May, just based on where the business set at the end of the quarter. You're still talking about yellow in 2Q. So what elements of that green phase are you still not seeing?

這很有幫助。我很欣賞那裡的所有細節。然後，麥克，聽起來我們基本上已經直接過渡到您在五月制定的綠色階段，只是基於季度末的業務情況。你還在談論第二季度的黃色。那麼，綠色階段的哪些元素您還沒看到呢？

Chris, the perspective we have on yellow is that we're not yet green. But we're not in the red phase. And for example, we do have territories and regions that are up and positive. We are launching the new products. And we are back in the office, but we're not at 100% in both facilities while we ramp up, again, manufacturing to full production. That being said, you will have and we do have territories that are moving a bit back into the red relative to some of the access into the hospitals. And you have some areas that are moving forward into green. We're very pleased, as I announced. We're back in July reenrolling again and reactivated sites for the STEMI DTU study, so that's a positive. But we're not at every center yet.

克里斯，我們對黃色的看法是我們還不是綠色的。但我們還沒有處於紅色階段。例如，我們確實有一些地區和地區處於上升狀態且積極。我們正在推出新產品。我們回到了辦公室，但在我們再次將製造能力提升到全面生產的同時，我們的兩個工廠還沒有達到 100% 的狀態。話雖這麼說，但我們確實有一些地區，相對於進入醫院的一些通道來說，有些地區的赤字有所回升。有些領域正在朝向綠色邁進。正如我所宣布的那樣，我們非常高興。我們在 7 月再次重新註冊並重新啟動 STEMI DTU 研究站點，所以這是一個積極的結果。但我們還沒有到達每個中心。

So until we get to every center, until we get to the -- we're no longer seeing some of the flare-ups or the ICU constraints, we're not in the green phase. But we're able to look at territories and say, by the end of this quarter, we will have territories that are green, and we will have certain territories that maybe flip back to red and hopefully get out of it as fast as we can. We're also pleased that the societies and the government agencies have really stressed the importance to treat high-risk essential emergency patients. Most of our patients have an imminent risk of death if they're not treated, and therefore, they're putting in the processes and the protocols into the hospitals. And many of the hospitals give us access, but even if we don't have direct access into the room, we do with our call center. And again, with Impella Connect, we're managing and monitoring these patients real time in the cloud.

因此，在我們到達每個中心之前，直到我們到達——我們不再看到一些突發事件或 ICU 限制，我們還沒有處於綠色階段。但我們可以查看領土並說，到本季末，我們將擁有綠色的領土，我們將擁有某些可能會變回紅色的領土，並希望盡快擺脫它。我們也很高興地看到，社會和政府機構確實強調了治療高危急症患者的重要性。我們的大多數患者如果不接受治療，都有迫在眉睫的死亡風險，因此，他們將流程和方案引入醫院。許多醫院都允許我們進入，但即使我們無法直接進入房間，我們也可以透過呼叫中心進入。再次，透過 Impella Connect，我們在雲端即時管理和監控這些患者。

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。

Just a question on the COVID impact in the quarter. More specifically, the potential positive sales impact with the EUA for RP. I appreciate the left heart did not come until this month or very recently, so no impact there. Any way to quantify sort of how much of sales was tied to COVID patients?

只是關於本季新冠疫情影響的問題。更具體地說，EUA 對 RP 的潛在積極銷售影響。我很感激左心直到這個月或最近才出現，所以沒有影響。有什麼方法可以量化與新冠患者相關的銷售額有多少嗎？

That's a good question. From what we track, we have over 400 COVID or suspected COVID patients. But in many ways, you're reading about things around organ failure shock or myocarditis, that we've been talking about for 10 years, and those are indications were already approved by the FDA. So I think Danielle, the visibility of what's happening where the lungs progress to the heart and it causes kidney failure, the whole element of Impella plus with ECPELLA gives us the ability to break that chain and still drive not just survival but native heart recovery. The story that we highlighted of [Devon] is truly remarkable. And just to point out, again, to everyone is his native heart function now is back to normal. And so that's the ultimate goal. The ultimate goal should not be survival and then have to go on to other surgeries or a transplant. And I think that what COVID has done is it has increased organ failure, it has increased the need for respiratory failure, so that should drive an increase in ECPELLA. But it's also allowed for people to understand the protocols and looking for what's the cause of death. And the ultimate cause of death is either respiratory failure or heart pump failure. And so for both of those technologies, that's where we're uniquely positioned now to provide a solution and again, with the goal of native heart recovery.

這是個好問題。根據我們的追踪，我們有 400 多名新冠肺炎或疑似新冠肺炎患者。但在很多方面，您正在閱讀有關器官衰竭休克或心肌炎的內容，我們已經討論了 10 年，而這些適應症已經獲得 FDA 批准。所以我認為 Danielle，肺部進展到心臟並導致腎衰竭的情況的可見性，Impella plus 和 ECPELLA 的整個元素使我們有能力打破這個鏈條，並且仍然不僅能推動生存，還能推動原生心臟恢復。我們強調的[德文郡]的故事確實非常了不起。再次向大家指出，他的心臟功能現在已經恢復正常。這就是最終目標。最終目標不應該是生存然後必須繼續進行其他手術或移植。我認為新冠肺炎增加了器官衰竭，增加了呼吸衰竭的需要，因此應該會推動 ECPELLA 的增加。但它也可以讓人們了解協議並尋找死因。最終的死亡原因是呼吸衰竭或心臟泵衰竭。因此，對於這兩種技術，我們現在處於獨特的地位，可以提供解決方案，並再次實現原生心臟恢復的目標。

Right. So I guess the point is, it doesn't matter what causes those issues, whether it's COVID or not, Impella or ECPELLA helps. Okay. So that makes sense. The other point…

正確的。所以我想重點是，導致這些問題的原因並不重要，無論是否是新冠病毒，Impella 或 ECPELLA 都會有所幫助。好的。所以這是有道理的。另一點…

Yes. And one point on that. If you look at diabetes and obesity, that's growing to the point that, that could impact 10% of the population. And obesity and type 2 diabetes causes heart attacks, coronary disease and all these other challenges that patients have. So unfortunately, heart failure is going to continue to grow at a faster pace now with COVID. And the population of 65 is growing 44%, but also the population between 45 and 65 is also showing an increased mortality rate from heart failure.

是的。關於這一點還有一點。如果你看看糖尿病和肥胖症，你會發現這種情況正在發展到可能影響 10% 人口的程度。肥胖和第 2 型糖尿病會導致心臟病、冠心病以及患者面臨的所有其他挑戰。不幸的是，隨著新冠病毒的出現，心臟衰竭將繼續以更快的速度成長。 65 歲人口增加了 44%，但 45 歲至 65 歲人口的心臟衰竭死亡率也有所增加。

Understood. Okay. And you sort of alluded to this in the prepared remarks. But does the COVID dynamic actually motivate hospitals in a bigger way to establish and enforce protocols for cardiogenic shock and maybe even high-risk PCI? Now in this environment, hospitals are crunched for time and money. So perhaps protocols increase efficiency, while also improving outcomes. Is there any dynamic you're seeing there? Or am I stretching too much to get to that?

明白了。好的。你在準備好的發言中提到了這一點。但新冠肺炎疫情是否真的會更大程度地激勵醫院制定和執行心因性休克甚至高風險 PCI 治療方案？現在在這種環境下，醫院的時間和金錢都十分緊張。因此，也許協議可以提高效率，同時也改善結果。你在那裡看到什麼動態嗎？或者我伸展太多而無法做到這一點？

I think so. I think that's the way we look at it. It's also why we're doing these weekly calls to constantly talk about best practices, what are we learning about COVID, what are we learning about the treatment. You have COVID on the left side with the heart and the lungs, but you also have COVID causing inflammation, which increases the clotting risk. And so if a patient gets a clot in their lungs or pulmonary embolism, what happens is the right ventricle gets overwhelmed trying to pump across that extra resistance, and that can cause right heart failure. So by putting an Impella RP, the pump can take over the work of ventricle, it can reduce the oxygen demand for both right and by subsequent left ventricles themselves and it allows the physicians to either do TPA to break up the clot or do an aspiration device to suck it out. So there's just lots of tools we're enabling now, but all education is helpful, and that's what we're trying to do as much as we can through these virtual calls and live cases.

我想是這樣。我認為這就是我們看待它的方式。這也是為什麼我們每週都會打電話來不斷討論最佳實踐、我們對新冠病毒的了解以及我們對治療的了解。您的左側心臟和肺部感染了新冠病毒，但新冠病毒也會引起炎症，增加凝血風險。因此，如果患者肺部出現血栓或肺栓塞，右心室會因試圖泵送額外的阻力而不堪重負，可能導致右心衰竭。因此，透過放置 Impella RP，幫浦可以接管心室的工作，它可以減少右心室和隨後的左心室本身的氧氣需求，並且允許醫生進行 TPA 來分解血栓或進行抽吸將其吸出的裝置。因此，我們現在啟用了很多工具，但所有教育都是有幫助的，這就是我們試圖透過這些虛擬通話和現場案例盡可能做到的事情。

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。

Not to keep beating a dead horse here on July. But Todd, you've got a lot of data on the U.S. specifically. And the patient number in the quarter -- sorry, in the month is likely going to get some attention. So what are you seeing between some of the breakout areas, Texas, Florida, Arizona in terms of contraction in patients versus areas that are less affected? So COVID affected areas, are they down 10%-ish, more than that in July and then other areas are up 5%, 6%? How do we think about that?

不要在七月繼續在這裡打死馬。但是托德，你有很多關於美國的數據。本季度的患者數量——抱歉，本月可能會引起一些關注。那麼，您認為德州、佛羅裡達州、亞利桑那州等一些疫情爆發地區與受影響較小的地區相比，患者數量減少了多少？那麼受新冠疫情影響的地區是否比 7 月下降了 10% 左右，然後其他地區則上漲了 5%、6%？我們對此有何看法？

Yes. No, it's a great question. We do have -- I mean, obviously, we do track patients every day by hospital, by physician. And if you think about the hotspots in the United States, which were, obviously, Florida, Texas, a little bit of Arizona and California, that represents almost 30% of our volumes. And for the month of July, for example, Texas was down close to 30%. And we're seeing not as bad of declines in Florida and California, but still declines more than the 4%. So we are seeing an impact of COVID resurgence in these areas. The one thing I would say, Matt, is that the fact of -- it's not like we saw in New York, right? New York was overwhelmed, New York was, some would call, broken, and we saw, for example, in April, in New York, our patients were down 90%. They bounced back in June, they were up 45%. So we know at the end of the day that these patients are sick, they're not elective, and that, obviously, we'll see an impact for a month, but there will be -- there should be a bounce back based on what we saw in Q1.

是的。不，這是一個很好的問題。我們確實有——我的意思是，顯然，我們確實每天按醫院、按醫生跟踪患者。如果你考慮美國的熱點地區，顯然是佛羅裡達州、德克薩斯州、亞利桑那州和加利福尼亞州的一小部分，那麼這幾乎占我們銷售的 30%。例如，德州 7 月的房價下跌了近 30%。我們看到佛羅裡達州和加州的跌幅沒有那麼嚴重，但跌幅仍然超過 4%。因此，我們看到了新冠疫情在這些地區捲土重來的影響。馬特，我要說的一件事是，事實與我們在紐約看到的不同，對吧？紐約不堪重負，有些人會說，紐約已經支離破碎，我們看到，例如，四月，在紐約，我們的病人減少了 90%。他們在 6 月反彈，上漲了 45%。因此，我們最終知道這些患者生病了，他們沒有選擇性，顯然，我們會看到一個月的影響，但應該會出現反彈我們在第一季看到的情況。

Okay. And that Texas example you provided, you didn't lose a bunch of customers or anything like that in Texas specifically that would explain it, it's really COVID specific that's impacting the business.

好的。你提供的德克薩斯州的例子，你並沒有失去一群客戶或類似的德克薩斯州的具體情況可以解釋這一點，這確實是新冠疫情對業務的影響。

It's specifically COVID related. And it's not all in Texas.

這與新冠病毒特別相關。而且這並不全在德州。

Got it. Okay. That's really helpful. And then, Mike, you've been touching on this throughout the call. I know you don't want to capitalize on a pandemic. But the technology has been underutilized in a lot of areas for a long time. What kind of catalyst is this going to provide? Again, you talked about RP a little bit, ECPELLA, cardiomyopathy, et cetera. What areas underlying here is this going to really catalyze going forward that may be difficult for investors to see at the moment?

知道了。好的。這真的很有幫助。然後，麥克，你在整個電話會議中一直談到這一點。我知道你不想利用大流行病。但長期以來，這項技術在許多領域都沒有充分利用。這將提供什麼樣的催化劑？您再次談到了 RP、ECPELLA、心肌病變等。這將真正促進投資者目前難以看到的哪些潛在領域的發展？

I think the first subtle point, Matt, is high-risk PCI provides a minimally invasive procedure for a patient. So as compared to CABG or open heart surgery, it could be a preferred mode now for high-risk patients because it's a shorter hospital stay. The second component is for these patients, you want to get it done right, protect the patient, so they don't have a hospital -- longer hospital stay, and you need to get complete revascularization in a single setting rather than staging patients. So I think we do see that in areas, as Todd mentioned, in June, AMI shock was around 10% growth and high-risk PCI was flat. So that was the opposite of what happened in April, where everything was down, but high-risk PCI was down more. So there's a certain resiliency in our technology because even our high-risk PCI patients aren't technically elective. It's not an orthopedic procedure. And 40% of our high-risk PCI patients are urgent. So they're being admitted into the hospital with chest pain and need to be treated.

Matt，我認為第一個微妙點是高風險 PCI 為患者提供了微創手術。因此，與冠狀動脈繞道手術或心臟直視手術相比，它可能是高風險患者的首選模式，因為它的住院時間較短。第二個組成部分是針對這些患者，您希望正確完成治療，保護患者，這樣他們就沒有醫院——住院時間更長，並且您需要在單一環境中進行完全血運重建，而不是對患者進行分期。因此，我認為我們確實看到，正如托德提到的，6 月份，AMI 衝擊增長了 10% 左右，高風險 PCI 持平。這與 4 月的情況相反，當時一切都下降了，但高風險 PCI 下降得更多。因此，我們的技術具有一定的彈性，因為即使是我們的高風險 PCI 患者在技術上也不是選擇性的。這不是骨科手術。我們的高風險 PCI 患者中有 40% 是緊急的。因此，他們因胸痛而入院，需要接受治療。

For the shock side, I just think that more education that's out there on what causes a lack of oxygenation and what happens when the heart goes into cardiogenic shock and what's the impact of the kidneys. And so what we've been talking about for many years is this element that unloading itself creates a positive cascade. It rests the myocardium, it helps it to recover, it's actually in our FDA label that it's a therapy to allow for native heart recovery. We've also been publishing papers and talking about the benefits on unloading the heart has a positive impact on the kidneys themselves, allows the kidneys to turn back on, make urine and get the impurities out of the body that's in the blood. So there's just -- the whole component now of evolving that and now adding in the need for oxygenation leads to more ECPELLA discussions because the end goal for all of these patients has got to be survival with native heart recovery. And in the news, there's constant new vaccines and other drugs, and there was a lot of press on ventilators being used for the right reasons. But ultimately, what we're trying to do is get patients home with their own heart.

對於休克方面，我只是認為應該進行更多的教育，了解導致缺氧的原因、心臟發生心臟休克時會發生什麼事以及腎臟的影響。因此，我們多年來一直在談論的是卸載本身會產生積極級聯的這個元素。它可以讓心肌休息，幫助心肌恢復，實際上在我們的 FDA 標籤中，它是一種允許原生心臟恢復的療法。我們也發表了論文，討論了減輕心臟負擔的好處對腎臟本身有積極的影響，讓腎臟重新啟動，產生尿液，並將血液中的雜質排出體外。因此，現在的整個組成部分正在不斷發展，現在增加了氧合的需要，這導致了更多的 ECPELLA 討論，因為所有這些患者的最終目標必須是生存和自然心臟恢復。在新聞中，不斷有新的疫苗和其他藥物出現，並且有很多關於出於正確原因使用呼吸器的新聞。但最終，我們要做的是讓患者帶著自己的心回家。

Our next question comes from Jayson Bedford from Raymond James.

我們的下一個問題來自雷蒙德詹姆斯的傑森貝德福德。

Just a few questions here. There's been a lot of discussion around revenue growth versus patient growth. Excluding the ASP uplift tied to moving from CP -- or 2.5 to CP, 5.0 to the 5.5, can we assume that pricing in the quarter was generally stable?

這裡只是幾個問題。關於收入成長與患者成長的討論有很多。排除與從 CP 移動（或從 2.5 移動到 CP、從 5.0 移動到 5.5）相關的平均售價提升，我們是否可以假設本季的定價總體穩定？

Yes. So we -- just to clarify, we provided in our third slide on the investor deck, we broke out, you'll see on that bottom, there's 2 boxes. So you got April, May and June, and April, May and June had sequential lift. And then we also broke out to provide complete transparency for June, let everyone see the patient growth and the revenue growth. So as you can see, the U.S. patient growth was 7%. The mix is changing, but the ASPs for the products are the same. And so that's the gist of your question. As we move forward into July, when we see an area down, there's a direct correlation with some of the spike in COVID. So outside of the spike in COVID, which we think we see a rebound now as we've seen in New York and some of these other areas, including in Italy, is we feel confident moving forward that we have a good balance now between patients and revenue growth, and we have a playbook in order to go into these territories that might have a flare-up in COVID to allow for these cardiovascular, these high-risk essential patients to be treated. And so that mix is not necessarily driven by purely price, it's being driven by some of the COVID restrictions. And then the last is, we appreciate it's a challenging time to give guidance. So we're going to -- we're providing all these details so that you can see how we're managing it. And remember that when we say there's an impact in Texas, it's not all regions in Texas, it's not even every hospital. Because we have the IQ database and the telesales and Impella Connect, we're able to see it as it's happening real time in specific hospitals with specific physicians.

是的。所以我們——只是為了澄清，我們在投資者平台上的第三張幻燈片中提供了，我們爆發了，你會在底部看到，有兩個盒子。所以你得到了四月、五月和六月，並且四月、五月和六月有連續的提升。然後我們也爆出6月的數據完全透明，讓大家看到病人的成長和收入的成長。如您所見，美國患者成長率為 7%。組合正在發生變化，但產品的平均售價是相同的。這就是你問題的要點。當我們進入 7 月時，當我們看到某個區域出現下降時，這與新冠​​疫情的某些高峰有直接相關性。因此，除了新冠疫情激增之外，我們認為我們現在看到了反彈，就像我們在紐約和其他一些地區（包括義大利）看到的那樣，我們對前進充滿信心，因為我們現在在患者之間取得了良好的平衡和收入成長，我們有一個劇本可以進入這些可能出現新冠疫情爆發的地區，讓這些心血管疾病、這些高風險的基本患者得到治療。因此，這種組合不一定是純粹由價格驅動的，而是由一些新冠限制措施驅動的。最後一點是，我們意識到現在是提供指導的充滿挑戰的時期。因此，我們將提供所有這些詳細信息，以便您可以了解我們是如何管理它的。請記住，當我們說德克薩斯州受到影響時，並不是德克薩斯州的所有地區，甚至不是每家醫院。因為我們擁有 IQ 資料庫、電話銷售和 Impella Connect，所以我們能夠看到特定醫院和特定醫生即時發生的情況。

Okay. But again, as I look at the slide, patient growth was up 7% in the U.S., revenue growth was up 3%, implying some sort of price degradation. I'm guessing that is not the case.

好的。但同樣，當我查看投影片時，美國的患者成長了 7%，收入成長了 3%，這意味著某種價格下降。我猜情況並非如此。

That is not the case. Jayson, that's not the case at all. I mean the month of June, it would've been the lower reorder rates and it would've been less deals. That's really -- I mean because at the end of the day, it's 22% patient utilization and 21% growth. So it's very close. And so there's a little bit of puts and takes, but there's no degradation of price.

事實並非如此。傑森，事實並非如此。我的意思是六月，再訂購率會較低，交易也會減少。這確實是——我的意思是因為最終，患者利用率為 22%，成長率為 21%。所以它非常接近。因此，雖然有一些看跌期權和賣出選擇權，但價格並沒有下降。

Okay. Okay. That's fair. And that's what I suspected. Wanted to ask about 5.5, and I appreciate this is a difficult environment to gauge this. But is 5.5 growing in the market? Or do you see it as largely cannibalizing 5.5 at this point -- 5.0 at this point?

好的。好的。這還算公平。這就是我所懷疑的。想詢問有關 5.5 的問題，我知道這是一個很難衡量這一點的環境。但 5.5 的市場正在成長嗎？還是你認為它在很大程度上蠶食了 5.5——此時的 5.0？

Both. The 5.5 is a breakthrough product. If you watched the Investor Day, Dr. Ed Soltesz from Cleveland Clinic talked about the ease of putting it in, talked about the blood compatibility based on publications and the FDA testing parameters. We believe it's the most blood compatible heart pump ever made. And it really allows for higher flow for patients that have shock including patients that are acutely decompensating that are more heart failure chronic patients.

兩個都。 5.5 是一款突破性產品。如果您觀看了投資者日活動，克利夫蘭診所的 Ed Soltesz 博士談到了植入的簡單性，談到了基於出版物和 FDA 測試參數的血液相容性。我們相信它是迄今為止與血液最相容的心臟泵。它確實為休克患者提供了更高的流量，包括急性失代償的患者，即更多患有心臟衰竭的慢性患者。

Okay. And Mike, just -- I think 5.5 has been out in Germany a couple of years. I forget the exact approval time line. Can you just talk about the use of 5.5 versus 5.0 in Germany today?

好的。麥克，我認為 5.5 已經在德國推出幾年了。我忘了具體的審批時間。您能談談今天德國 5.5 與 5.0 的使用情況嗎？

Yes. So the 5.0 is still available. It's a lower price point, and it has it's a little more difficult to place. In Germany, we're working through reimbursement issues to -- as we go through the cycle. It's a bit of a higher price point, and the same will be true in the U.S., but both products are naturally driving into the 5.5 market. So the 5.0 and the LD, that's the direct, you're able to do both with the 5.5. You can place it direct or you can place it with the chest open or you can place it through the axillary artery. And so I think that's where the market is going to go long term.

是的。所以5.0還是可以用的。它的價格較低，而且放置起來有點困難。在德國，我們正在解決報銷問題——隨著我們經歷這個週期。價格有點高，在美國也是如此，但這兩款產品自然會進入 5.5 市場。所以 5.0 和 LD，這就是直接的，你可以用 5.5 來完成這兩個任務。您可以直接放置，也可以在胸腔打開的情況下放置，也可以透過腋動脈放置。所以我認為這就是市場長期發展的方向。

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 one clarification on June and July. So just curious, is the growth rate you have quoted for June and July inclusive of contribution or benefit from extra selling days? And if so, how many extra selling days are there relative to last year? And the same question for July. And I just have a quick follow-up.

這是加爾文替大衛發言。僅對六月和七月進行一次澄清。所以只是好奇，您所報的 6 月和 7 月成長率是否包含額外銷售天數的貢獻或收益？如果是的話，與去年相比，銷售天數增加了多少天？七月也有同樣的問題。我只是進行了快速跟進。

Yes. Calvin, this is Todd. So we have 30-patient days in June this year versus last year, and that's how we look at the business, right? So we treat patients every day of the month. Obviously, we had a few more workdays this June versus last June. And if you look at some of the patient volumes in the weekends versus weekdays, there is a little bit of a difference there. So that might have been maybe one point of growth, but we had the same opposite effect in the month of May. So from a quarter standpoint, it nets out.

是的。卡爾文，這是陶德。因此，與去年相比，今年 6 月我們有 30 個病人日，這就是我們看待業務的方式，對吧？所以我們每個月的每一天都在治療病人。顯然，今年六月比去年六月多了幾個工作天。如果你看一下週末和工作日的一些病人數量，你會發現有些差異。所以這可能是個成長點，但我們在五月也產生了相反的效果。因此，從四分之一的角度來看，它是淨值。

Got it. Understood. And just a quick follow-up on clinical trials and timing. Just -- have you guys said or disclosed on kind of estimated timing for PROTECT IV and RECOVER IV enrollment completion and readout?

知道了。明白了。只是臨床試驗和時間安排的快速跟進。只是——你們有沒有說過或透露 PROTECT IV 和 RECOVER IV 註冊完成和讀出的預計時間？

We haven't given the specifics on completion, especially in the COVID times here. However, we have said that we anticipate doing our first patient at the end of our fiscal year, but we'll be obviously monitoring that with the COVID experience around these research centers. We're very excited that the STEMI DTU study is up and running. And as I said, we've had 5 patients enrolled in July, and we're going to continue to focus on proper execution of both studies.

我們還沒有給出完成的具體細節，尤其是在新冠疫情時期。然而，我們已經說過，我們預計會在本財年結束時對第一位患者進行治療，但我們顯然會根據這些研究中心周圍的新冠疫情經驗來監測這一情況。我們非常高興 STEMI DTU 研究已經啟動並運行。正如我所說，我們在 7 月招募了 5 名患者，我們將繼續專注於兩項研究的正確執行。

And our next question comes from Chris Cooley from Stephens.

我們的下一個問題來自史蒂芬斯的克里斯·庫利。

Maybe just a quick one as a follow-up to the last kind of lot of questions. Could you maybe talk to us about what you can do to accelerate enrollment when we think about STEMI DTU? I know on the -- during the Investor Day, you mentioned some of the challenges associated with that here, the COVID environment. But are there ways in these riddled up centers that you can further accelerate that enrollment? And I'll just go ahead and ask my follow-up now in this session. You guys did a phenomenal amount of heavy lifting, while also changing strategically, I think, pretty significantly during the fiscal 1Q. When we think about Abiomed 2.0 now going forward, are there opportunities to use newer technologies like Connect and others to further accelerate or not just Connect but also just the online education to further accelerate adoption in kind of the community setting, more specifically around protected PCI?

也許只是一個快速的問題，作為最後一類問題的後續。當我們考慮 STEMI DTU 時，您能否與我們談談您可以採取哪些措施來加快入學速度？我知道在投資者日期間，您提到了與新冠疫情環境相關的一些挑戰。但在這些擁擠不堪的中心，是否有辦法進一步加快招生速度呢？我現在將在本次會議中繼續詢問我的後續行動。我認為，你們在第一財季做了相當多的繁重工作，同時也進行了策略上的改變，變化相當大。當我們考慮Abiomed 2.0 的未來發展時，是否有機會使用Connect 等新技術來進一步加速，或者不僅是Connect，還包括線上教育，以進一步加速社區環境中的採用，更具體地說是圍繞受保護的PCI ？

So Chris, thanks for the question. I'll answer the second one first. CAMP PCI is 100% focused on creating that network, the user group. Every Wednesday, we have live cases now from around the country, and it's been very helpful. I do think it creates awareness with the physicians that are calling in, talking about how they treat these patients, and I -- and we do expect it will drive -- protected PCI will drive some of the awareness of the treatment protocols. And we're very excited because physicians now routinely log in calls. They see this as the future. They enjoy getting access to the world's experts and watching these cases. And we're very pleased and very excited, and I think Abiomed 2.0, part of the big game changer for us is physicians wanting to use this type of user network like CAMP PCI.

克里斯，謝謝你的提問。我先回答第二個問題。 CAMP PCI 100% 專注於建立該網絡，即使用者群組。每個星期三，我們都會收到來自全國各地的即時案例，這非常有幫助。我確實認為它提高了打電話來的醫生的意識，談論他們如何治療這些患者，而且我 - 我們確實希望它會推動 - 受保護的 PCI 將提高人們對治療方案的認識。我們非常興奮，因為醫生現在經常撥打電話。他們認為這是未來。他們喜歡接觸世界各地的專家並觀看這些案例。我們非常高興和興奮，我認為 Abiomed 2.0 對我們來說是重大遊戲規則改變者的一部分，是希望使用 CAMP PCI 等此類用戶網路的醫生。

For your first question on STEMI DTU, there are things we can do. We're doing it, but a lot has to do with just working with our physicians, identifying the STEMI patients. With the recent guidance documents that are out there, I think there is a lot more visibility again to try to drive the STEMI DTU patients to the hospitals. And our physicians tend to be the thought leaders and the influential folks around the country.

對於您關於 STEMI DTU 的第一個問題，我們可以做一些事情。我們正在這樣做，但很大程度上需要與我們的醫生合作，識別 STEMI 患者。有了最近發布的指導文件，我認為嘗試將 STEMI DTU 患者送往醫院的知名度再次提高。我們的醫生往往是全國各地的思想領袖和有影響力的人物。

And our next question comes from Marie Thibault from BTIG.

我們的下一個問題來自 BTIG 的 Marie Thibault。

I'll ask just one here. I'm curious what you're hearing from your hospital customers on patient willingness to come in at this point. And given sort of the urgent and emergent nature of many of your procedures, when do you think you might have worked through sort of the majority of that deferred patient backlog that we had from April?

我在這裡只問一個。我很好奇您從醫院客戶那裡聽到的關於患者此時就診的意願的資訊。考慮到你們的許多程序的緊急性和緊急性，您認為你們什麼時候可以完成我們從四月以來推遲的大部分患者積壓工作？

Marie, a good question. And the answer is it's the yellow phase. So in some areas, they are making progress. The hospitals and the societies have been successful at getting people to understand the risk of staying at home with chest pain or having a heart attack. And you have sites in areas that are positive and doing well and you have other sites where there is more fear. Part of it has to do with the regional nature and what's happening with the restrictions by the government. But for the most part, everybody knows now that the risk of staying at home with a heart attack is far greater than the risk of contracting COVID-19. And I think as the logistics is worked through, the next phase of this is people understanding the anxieties. We're very confident in our physicians and these hospitals that they are completely dedicated, committed to these patients, and whether the patient has COVID-19 or not, there's lots of guidelines and protocols now of how to treat these patients even with COVID-19 that are having emergency cardiovascular issues. Thanks for the question.

瑪麗，好問題。答案是黃色階段。所以在某些領域，他們正在取得進展。醫院和社團已經成功地讓人們了解了待在家中患有胸痛或心臟病發作的風險。您的網站位於積極且表現良好的領域，而您的其他網站則有更多恐懼。部分原因與地區性質以及政府限制措施有關。但現在大多數人都知道，待在家裡罹患心臟病的風險遠大於感染 COVID-19 的風險。我認為，隨著後勤工作的完成，下一階段就是人們理解人們的焦慮。我們對我們的醫生和這些醫院非常有信心，他們完全致力於這些患者，致力於為這些患者服務，無論患者是否患有COVID-19，現在都有很多關於如何治療這些患者的指南和方案，即使患者患有COVID-19 - 19 名患有緊急心血管問題的人。謝謝你的提問。

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

今天的電話問答環節就到此結束了，現在我想將會議轉回麥克·米洛（Mike Minogue）做總結發言。

Thank you, everyone, for your time today. If you have any follow-up questions, feel free to reach out, and have a great day.

謝謝大家今天抽出時間。如果您有任何後續問題，請隨時與我們聯繫，並祝您有美好的一天。

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

女士們、先生們，感謝您參加今天的電話會議。這確實結束了程序，你們都可以斷開連接。祝大家有美好的一天。