ABIOMED Inc (ABMD) 2023 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Abiomed FY '23 Q1 Earnings Call. (Operator Instructions)

美好的一天，感謝您的支持。歡迎參加 Abiomed 23 財年第一季財報電話會議。 （操作員說明）

I will now turn the conference over to Nicole Nath, Head of Investor Relations. Please go ahead.

我現在將會議交給投資者關係主管 Nicole Nath。請繼續。

Good morning, and welcome to Abiomed's First Quarter Fiscal 2023 Earnings Conference Call. This is Nicole Nath, Head of Investor Relations, and I'm here with Mike Minogue, Abiomed's Chairman, President and Chief Executive Officer; and Todd Trapp, Vice President and Chief Financial Officer.

早安，歡迎參加 Abiomed 2023 財年第一季財報電話會議。我是投資者關係主管妮可·納斯 (Nicole Nath)，我和 Abiomed 董事長、總裁兼執行長 Mike Minogue 在一起。副總裁兼財務長 Todd Trapp。

The format for today's call will be as follows. First, Mike will discuss first quarter business and operational highlights, and then Todd will review our financial results, which were outlined in this morning'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，然後托德將回顧我們的財務業績，這些業績已在今天上午的新聞稿中概述。之後，我們將打開電話回答您的問題。

During the call, we will discuss certain financial information on a non-GAAP basis. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP. Reconciliations between GAAP and non-GAAP results are presented in the tables accompanying our earnings release.

在電話會議期間，我們將討論非公認會計準則基礎上的某些財務資訊。提供此非公認會計準則資訊是為了增強您對我們目前財務表現的整體了解。不應孤立地考慮此附加資訊的呈現，也不應將其視為結果的替代品或優於根據 GAAP 準備的結果。公認會計原則和非公認會計原則結果之間的對帳顯示在我們的收益發布所附的表格中。

Finally, I would like to remind everyone that today's call includes forward-looking statements. The company cautions investors that any forward-looking statements involve risks and uncertainties 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.

最後，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, Nicole, and good morning, everyone. In the first quarter of fiscal year 2023, Abiomed delivered a company record of $277 million in revenue, up 10% on a reported basis and up 12% in constant currency year-over-year with quarterly records across the U.S., Europe and Japan. Abiomed has achieved record revenue in 5 of the last 6 quarters despite ongoing headwinds with COVID variants, hospital labor shortages, supply chain constraints and most recently, contrast media shortages.

謝謝妮可，大家早安。 2023 財年第一季度，Abiomed 實現了公司創紀錄的 2.77 億美元收入，按報告計算增長 10%，按固定匯率計算同比增長 12%，在美國、歐洲和日本均創下季度記錄。儘管受到新冠病毒變異、醫院勞動力短缺、供應鏈限制以及最近的造影劑短缺等持續不利因素的影響，Abiomed 在過去 6 個季度中有 5 個季度實現了創紀錄的收入。

Abiomed 2.0 has proven to be resilient because our technology and 24/7 hospital support addresses the growing epidemic of heart disease in multiple emergency patient populations in the cath lab and surgical suite. Within the quarter, we supported a record number of patients in the U.S. and had the second highest patient utilization in Europe and Japan. We remain focused on innovation and strengthening clinical evidence, investing $41 million in research and development while achieving 23.8% operating margins.

Abiomed 2.0 已被證明具有彈性，因為我們的技術和 24/7 醫院支援解決了導管實驗室和手術室中多個急診患者群體日益流行的心臟病問題。在本季度內，我們在美國支持的患者數量創下了紀錄，並且在歐洲和日本的患者利用率位居第二。我們仍專注於創新和加強臨床證據，投資 4,100 萬美元用於研發，同時實現 23.8% 的營業利潤率。

Our IP portfolio continues to grow with 1,487 patents and 1,610 patents pending. We ended the quarter with just over $1 billion in cash and maintained 0 debt. Additionally, this morning, we announced a new $200 million share repurchase program, a component of our capital deployment strategy upon completion of our anticipated closure of the prior $200 million plan.

我們的智慧財產權組合持續成長，擁有 1,487 項專利和 1,610 項正在申請的專利。本季結束時，我們的現金略高於 10 億美元，債務為零。此外，今天早上，我們宣布了一項新的 2 億美元股票回購計劃，這是我們在完成之前 2 億美元計劃的預期結束後的資本部署策略的一部分。

Our continued strong financial and operational performance is a result of our disciplined execution of our Abiomed 2.0 playbook which enables us to innovate breakthrough technology, advance clinical research and support record levels of patients in this dynamic environment. For today's call, I'd like to highlight the continued strength of our surgical products, driven by heart recovery with Impella 5.5. Second, we will review publications of clinical data that validate the benefits associated with Impella-supported PCI procedures. And finally, we will cover the progress we've made in our pursuit of classroom guidelines with multiple pivotal trials.

我們持續強勁的財務和營運表現得益於我們嚴格執行 Abiomed 2.0 手冊，這使我們能夠在這個動態環境中創新突破性技術、推進臨床研究並支持創紀錄的患者水平。在今天的電話會議中，我想強調我們的外科產品在 Impella 5.5 心臟恢復的推動下的持續優勢。其次，我們將審查已發表的臨床數據，這些數據驗證了 Impella 支持的 PCI 手術的相關益處。最後，我們將透過多項關鍵試驗介紹我們在追求課堂指南方面取得的進展。

Starting with surgery. In the U.S., surgical revenue grew 49% year-over-year, driven by a 66% increase in Impella 5.5. This revolutionary surgical heart pump with SmartAssist provides unique advantages for the chronic heart failure patient population suffering from cardiogenic shock. As presented during our June investor call with Dr. Jane Wilcox and Dr. David D'Alessandro from Northwestern Memorial and Mass General Hospital, respectively, this game-changing technology has improved patient outcomes with 75% survival rate across all indications and 60% of patients returning home with their native hearts.

從手術開始。在美國，由於 Impella 5.5 成長 66%，手術收入較去年同期成長 49%。這款配備 SmartAssist 的革命性手術心臟幫浦為患有心因性休克的慢性心臟衰竭患者群體提供了獨特的優勢。正如我們在6 月分別與西北紀念醫院和麻省總醫院的Jane Wilcox 博士和David D'Alessandro 博士舉行的投資者電話會議中所介紹的那樣，這項改變遊戲規則的技術改善了患者的治療結果，所有適應症的存活率達到75%，所有適應症的存活率達到60%。

These outcomes are particularly meaningful because these patients previously faced irreversible heart failure, which ultimately would have required a durable, implantable LVAD or heart transplant. I encourage all investors to watch this webcast on our Investor website.

這些結果特別有意義，因為這些患者以前曾面臨不可逆的心臟衰竭，最終需要持久的、可植入的 LVAD 或心臟移植。我鼓勵所有投資者在我們的投資者網站上觀看此網路廣播。

In Japan, we continue to find success with our controlled rollout of the Impella 5.5 with overwhelmingly positive surgical feedback. We've witnessed survival rates and duration of support similar to that in the U.S. in the early stages of our product launch. We anticipate the expansion of this innovation to new sites and surgeons in Japan, setting a stage for heart recovery in surgery and protocols for the future.

在日本，我們透過控制推出 Impella 5.5 繼續取得成功，並獲得了壓倒性的積極手術回饋。在產品發布的早期階段，我們見證了與美國相似的存活率和支持持續時間。我們預計這項創新將擴展到日本的新地點和外科醫生，為未來的心臟恢復手術和方案奠定基礎。

Turning to recent clinical data. Restore EF, a prospective multicenter study evaluating best practices in contemporary high-risk PCI practice, will be published later this month in JSCAI. It was most recently presented as an abstract at a large Cardiology meeting. At their 90-day follow-up, study participants had a 29% relative improvement in their baseline LV -- left ventricular ejection fraction, an overall 76% reduction in New York Heart Association Class III and Class IV heart failure symptoms and an overall 97% reduction in Canadian Cardiovascular Society Class III or Class IV angina symptoms.

轉向最近的臨床數據。 Restore EF 是一項評估當代高風險 PCI 實踐最佳實踐的前瞻性多中心研究，將於本月稍後在 JSCAI 上發表。它最近在一次大型心臟病學會議上作為摘要提出。在 90 天的追蹤中，研究參與者的基線 LV（左心室射血分數）相對改善了 29%，紐約心臟協會 III 級和 IV 級心臟衰竭症狀總體減少了 76%，總體改善了 97%。心血管協會III 級或IV 級心絞痛症狀減少百分比。

The Restore EF study combined with PROTECT 1, PROTECT II and PROTECT III FDA studies and multiple independent physician studies demonstrate definitive proof that Impella-supported high-risk PCI can lead to a more complete revascularization and considerable left ventricular ejection fraction improvement, which improves heart function and quality of life for the patients.

Restore EF 研究與PROTECT 1、PROTECT II 和PROTECT III FDA 研究以及多項獨立醫師研究相結合，明確證明Impella 支持的高風險PCI 可以實現更完全的血運重建和顯著的左心室射血分數改善，從而改善心臟功能患者的功能和生活品質。

AMI cardiogenic shock has one of the highest mortality rates in the field of medicine. These are patients sometimes showing up at the hospital, getting CPR and rushed to the cath lab. The survival rate has remained approximately 50% without Impella and associated best practices for the last 20 years. Impella technology is designed to not only improve survival but enable heart recovery. Impella best practices such as placing Impella pre-PCI should before the physician places stents, it's been developed by the recognized physician experts in the field of circulatory support and is published in multiple clinical studies over the last decade from the United States, Germany, Italy, Denmark and now Japan.

AMI 心因性休克是醫學領域死亡率最高的疾病之一。這些患者有時會出現在醫院，接受心肺復甦術並被送往導管室。過去 20 年，在沒有 Impella 和相關最佳實踐的情況下，存活率仍維持在 50% 左右。 Impella 技術的設計不僅可以提高存活率，還可以促進心臟復健。 Impella 最佳實踐，例如在PCI 前放置Impella 應該在醫生放置支架之前，它是由循環支持領域公認的醫生專家開發的，並在過去十年中發表在來自美國、德國、意大利的多項臨床研究中，丹麥，現在是日本。

In May, the International Journal of Cardiology published a meta-analysis of Impella pre-PCI versus post-PCI implantation in AMI cardiogenic shock. This publication summarized 13 papers, totaling 6,810 patients and demonstrated a statistically significant lower mortality with Impella implantation before the PCI or the physician placing stents. Multiple Impella studies demonstrate greater than 70% survival with greater than 90% native heart recovery. Heart recovery after AMI cardiogenic shock improves patient quality of life and makes Impella one of the most cost-effective therapies in the CMS Medicare population as well as private insurance.

5 月，《國際心臟病學雜誌》發表了一項針對 AMI 心因性休克的 PCI 前與 PCI 後植入的 Impella 的統合分析。該出版物總結了 13 篇論文，總計 6,810 名患者，並證明在 PCI 或醫生放置支架之前植入 Impella 可顯著降低死亡率。多項 Impella 研究顯示存活率超過 70%，自然心臟恢復率超過 90%。 AMI 心因性休克後的心臟恢復可改善患者的生活質量，並使 Impella 成為 CMS 醫療保險人群以及私人保險中最具成本效益的療法之一。

Lastly, I'd like to highlight our progress towards advancing clinical evidence through multiple pivotal trials. We had a record quarter for patient enrollment for both PROTECT IV and STEMI DTU. Starting with PROTECT IV. In Q1, we rolled -- enrolled 91 patients. PROTECT IV is one of the most comprehensive studies ever done in the cath lab. This landmark trial will compare the benefits of an Impella-supported high-risk PCI versus high-risk PCI without Impella support. Researchers will measure complete revascularization, improvement in patient quality of life and ejection fraction.

最後，我想強調我們透過多項關鍵試驗在推動臨床證據方面所取得的進展。 PROTECT IV 和 STEMI DTU 的患者入組人數創下了季度記錄。從 PROTECT IV 開始。在第一季度，我們招募了 91 名患者。 PROTECT IV 是導管實驗室有史以來進行的最全面的研究之一。這項具有里程碑意義的試驗將比較 Impella 支持的高風險 PCI 與無 Impella 支持的高風險 PCI 的優勢。研究人員將測量血管完全重建、病患生活品質和射血分數的改善。

For the STEMI DTU pivotal trial, we enrolled 45 patients in Q1. If successful, this trial could expand our indications into heart attack patients without cardiogenic shock, which represents a 200,000 patient population in the U.S. and 4 million patients worldwide that we do not treat today. I'm also excited to announce that in July, we received FDA IDE approval for RECOVER IV. This is an FDA randomized controlled trial comparing all-cause mortality of 30 days in patients with STEMI, cardiogenic shock with an Impella-based treatment strategy initiated prior to PCI versus a non-Impella-based standard of care treatment strategy.

對於 STEMI DTU 關鍵試驗，我們在第一季招募了 45 名患者。如果成功，這項試驗可以將我們的適應症擴大到沒有心因性休克的心臟病患者，這代表了美國的 20 萬名患者群體和全球 400 萬名患者，我們目前還沒有治療這些患者。我還很高興地宣布，7 月份，我們的 RECOVER IV 獲得了 FDA IDE 批准。這是一項 FDA 隨機對照試驗，比較了 STEMI、心因性休克患者在 PCI 之前採用基於 Impella 的治療策略與非基於 Impella 的標準護理治療策略的 30 天全因死亡率。

Our teams have worked closely with the FDA to generate a protocol focused on exception from informed consent or EFIC, which we believe will help enroll patients in what has historically been a difficult patient population to enroll due to ethical and logistical concerns. The study details are posted in our earnings slides.

我們的團隊與 FDA 密切合作，制定了一項側重於知情同意或 EFIC 例外的協議，我們相信這將有助於在歷史上由於道德和後勤問題而難以招募的患者群體中招募患者。研究詳細資訊發佈在我們的收益幻燈片中。

Our current RCTs are built off a decade of prior studies and best practices with the goal of achieving Class I guidelines, the highest level of medical guidelines for high-risk PCI, cardiogenic shock and STEMI. If successful, we believe we'll be the only company in medtech with exclusive FDA approvals, a dedicated IP portfolio and Class I guidelines.

我們目前的隨機對照試驗建立在十年前的研究和最佳實踐的基礎上，目標是實現 I 類指南，即針對高風險 PCI、心因性休克和 STEMI 的最高水平的醫療指南。如果成功，我們相信我們將成為醫療技術領域唯一一家獲得 FDA 獨家批准、專門的智慧財產權組合和 I 類指南的公司。

Before concluding, I'd like to share a patient's story. Ethan Bradshaw, 30 years old, is a state trooper from North Carolina. Motivated by a family history of heart disease, Ethan takes pride in living a healthy lifestyle. He exercises several times each week and is a Brazilian Jiu-Jitsu instructor. On February 24, 2022, after experiencing chest pain and numbness in his arm at the gym, Ethan drove himself to Kernersville Medical Center. Upon arrival in the emergency room, Ethan collapsed. Medical personnel shocked Ethan multiple times and performed CPR before transferring him to Forsyth Medical Center in Winston-Salem, North Carolina.

在結束之前，我想分享一個患者的故事。伊森‧布拉德肖 (Ethan Bradshaw)，30 歲，是來自北卡羅來納州的州警。受心臟病家族史的影響，伊森對健康的生活方式感到自豪。他每週運動幾次，是巴西柔術教練。 2022 年 2 月 24 日，伊森在健身房感到胸痛和手臂麻木後，自己開車去了克納斯維爾醫療中心。到達急診室後，伊森昏倒了。醫護人員對伊森進行了多次電擊並進行了心肺復甦，然後將他轉移到北卡羅來納州溫斯頓塞勒姆的福賽斯醫療中心。

Ethan was in cardiogenic shock when he got to the catheterization lab with a reduced ejection fraction of 20%. So his heart was working about 1/3 of its strength. Dr. Samuel Turner implanted Impella CP with SmartAssist before the PCI and placing stents. After 2 days of support, Ethan's heart function showed dramatic improvement and the Impella was weaned and removed utilizing SmartAssist. After 3 weeks in the hospital, Ethan returned home with his native heart. Ethan's heart function returned to normal, and in May, he returned to the line of duty.

當 Ethan 到達導管實驗室時，他處於心因性休克狀態，射血分數降低了 20%。所以他的心臟正在工作大約1/3的力量。 Samuel Turner 博士在 PCI 和放置支架之前植入了帶有 SmartAssist 的 Impella CP。經過 2 天的支持後，Ethan 的心臟功能顯著改善，並使用 SmartAssist 斷奶並移除了 Impella。在醫院住了三週後，伊森帶著他的原生心臟回家了。伊森的心臟功能恢復正常，並於五月重返工作崗位。

In July, 5 months after his heart event, Ethan and his wife, Makela, welcomed a baby boy, Ryan. Today, Ethan and Makela are visiting our headquarters in Danvers where they'll meet with employees and share their inspiring story of heart recovery as part of our Annual Patient Summit.

7 月，心臟病發作 5 個月後，伊森和他的妻子馬克拉迎來了一個男嬰瑞安。今天，伊森和馬克拉將參觀我們位於丹佛斯的總部，他們將在那裡與員工會面，並分享他們鼓舞人心的心臟復健故事，作為我們年度患者高峰會的一部分。

In conclusion, at Abiomed, we are developing a new field of heart recovery and relentlessly pursuing better clinical outcomes and Class I guidelines. In Q1, we made progress toward our goals and remain focused on developing smaller, smarter, more connected devices, accelerating enrollment in key clinical studies and building commercial excellence as we continue through our fiscal year.

總之，在 Abiomed，我們正在開發心臟恢復的新領域，並不懈地追求更好的臨床結果和 I 類指南。在第一季度，我們在實現目標方面取得了進展，並繼續專注於開發更小、更智慧、連接性更強的設備，加快關鍵臨床研究的註冊速度，並在整個財年繼續打造卓越的商業成果。

I would like to thank our employees and customers for their commitment to advancing the standard of care and recognize our shareholders for their continued support. I will now turn the call over to Todd Trapp, our CFO.

我要感謝我們的員工和客戶致力於提高護理標準，並感謝我們的股東的持續支持。我現在將把電話轉給我們的財務長 Todd Trapp。

Thanks, Mike, and good morning, everyone. In Q1, we delivered record revenue of $277 million, up 10% on a reported basis and 12% in constant currency versus prior year, with strong growth across the U.S., Europe and Japan.

謝謝麥克，大家早安。第一季度，我們實現了創紀錄的 2.77 億美元收入，按報告計算增長 10%，按固定匯率計算比上年增長 12%，美國、歐洲和日本業務增長強勁。

We executed our Abiomed 2.0 playbook to deliver these record results despite tough year-over-year comparisons and headwinds from hospital labor shortages, contrast media supply constraints and foreign exchange rates. During the quarter, we saw the U.S. dollar continue to strengthen, which resulted in a more unfavorable impact on revenue compared to exchange rates at the time of our last earnings call and a 2-point impact on first quarter revenue versus prior year.

儘管存在嚴峻的同比比較以及醫院勞動力短缺、造影劑供應限制和外匯匯率等不利因素，但我們還是執行了 Abiomed 2.0 策略，取得了這些創紀錄的成果。在本季度，我們看到美元繼續走強，與我們上次財報電話會議時的匯率相比，這對收入產生了更不利的影響，並對第一季度收入比去年同期產生了2 個百分點的影響。

Starting with the U.S. Total revenue increased 9% year-over-year to $227 million despite the challenging environment due to a 6% growth in patient utilization and favorable sales mix. As a reminder to investors, we grew revenue 54% in Q1 of last year. AMI cardiogenic shock continues to perform well with 10% growth in the quarter on top of 41% growth in the prior year. High-risk PCI was down 1% due to challenging comps of 51% growth in the prior year and the impact from both hospital labor shortages and contrast media supply.

從美國開始，儘管環境充滿挑戰，但由於患者利用率成長 6% 和有利的銷售組合，總收入年增 9% 至 2.27 億美元。提醒投資者，我們去年第一季的營收成長了 54%。 AMI 心因性休克持續表現良好，在去年成長 41% 的基礎上，本季成長了 10%。由於上一年增長 51% 的挑戰以及醫院勞動力短缺和造影劑供應的影響，高風險 PCI 下降了 1%。

Our U.S. surgical products had another strong quarter with 49% revenue growth, driven by continued demand for the Impella 5.5 with SmartAssist. At the end of our fiscal Q1, Impella CP is in 1,598 sites in the U.S. The Impella 5.5 is now in 444 sites, up 48 sites versus the prior quarter out of the potential 1,100 hospitals with surgical suites. Lastly, the Impella RP is in 675 sites. Details of our product installed base are summarized in our quarterly slide deck.

在對帶有 SmartAssist 的 Impella 5.5 的持續需求的推動下，我們的美國外科產品在本季度再次表現強勁，收入增長了 49%。截至第一財季末，Impella CP 已部署在美國 1,598 個地點。最後，Impella RP 分佈在 675 個站點。我們的產品安裝基礎的詳細資訊在我們的季度幻燈片中進行了總結。

Our U.S. reorder performance in the quarter was 101%, in line with the prior quarter and prior year. Average combined inventory at the hospitals for the Impella 2.5 and CP with 4.9 units per site, flat with the inventory levels we saw last quarter. Outside the U.S., revenue totaled $51 million, up 11% versus prior year on a reported basis and 27% in constant currency.

本季我們美國的再訂購績效為 101%，與上一季及前一年持平。醫院的 Impella 2.5 和 CP 平均合併庫存為每個站點 4.9 台，與我們上季度看到的庫存水準持平。美國以外地區的收入總計 5,100 萬美元，以報告數據計算，較上年增長 11%，以固定匯率計算，增長 27%。

European revenue increased 19% year-over-year in constant currency on top of 50% growth in the prior year due to patient utilization and favorable sales mix. We continue to see strong patient growth in countries and regions like Italy, Belgium, Austria and the Middle East.

由於患者利用率和有利的銷售組合，歐洲收入以固定匯率計算在上一年增長 50% 的基礎上同比增長 19%。我們持續看到義大利、比利時、奧地利和中東等國家和地區的患者強勁成長。

Our Japan business delivered revenue of $13 million in the first quarter. Revenue increased 39% year-over-year in constant currency, a new record, driven by a 25% growth in patient utilization and site openings. In the quarter, we opened 8 new sites, bringing our total to 199 out of the potential 450 sites. This compares to the 4 site openings last quarter and 5 site openings in Q1 of '22.

我們的日本業務第一季實現營收 1300 萬美元。在患者利用率和站點開放量成長 25% 的推動下，以固定匯率計算，營收年增 39%，創下新紀錄。本季度，我們開設了 8 個新站點，使潛在 450 個站點中的總數達到 199 個。相比之下，上個季度有 4 個站點空缺，22 年第一季有 5 個站點空缺。

Gross margin in Q1 was 81% compared to 82% in the same period of the prior year, primarily driven by lower production volume and manufacturing investment to support our future sales growth.

第一季的毛利率為 81%，而去年同期為 82%，主要是由於產量下降和製造投資支持我們未來的銷售成長。

R&D expense for the first quarter totaled $41 million, up 7% year-over-year. The increase was driven by the investment in both PROTECT IV and STEMI DTU randomized control trials associated with site openings and patient enrollment, partially offset by a reduction in our contingent consideration liability.

第一季研發費用總計4,100萬美元，較去年同期成長7%。這一增長是由與場地開放和患者入組相關的 PROTECT IV 和 STEMI DTU 隨機對照試驗的投資推動的，但我們或有考慮負債的減少部分抵消了這一增長。

SG&A expense for the quarter totaled $118 million, an increase of 14% versus prior year, driven by headcount additions to our commercial team, our patient therapy awareness campaign and continued training and education.

本季的 SG&A 費用總計 1.18 億美元，比去年同期增加 14%，這主要得益於我們的商業團隊人數增加、患者治療意識活動以及持續的培訓和教育。

Non-GAAP operating income was $66 million in the quarter, which translated to non-GAAP operating margin of 23.8% versus 26.2% in the prior year. The variance is due to ongoing investments in innovation, clinical research and commercial excellence as we pursue our goal of becoming the global standard of care for hemodynamic support.

本季非 GAAP 營業收入為 6,600 萬美元，換算成非 GAAP 營業利益率為 23.8%，而去年同期為 26.2%。這種差異是由於我們在追求成為血流動力學支持的全球護理標準的目標時對創新、臨床研究和商業卓越的持續投資所致。

Non-GAAP net income for the quarter was $57 million. This translated to earnings per share of $1.25, an increase of 14% versus Q1 of '22. Our year-over-year performance was driven by higher interest income, an adjustment to the carrying value of our strategic investments and a lower effective tax rate.

該季度非 GAAP 淨利潤為 5700 萬美元。這意味著每股收益為 1.25 美元，比 22 年第一季增長 14%。我們的年比績效是由較高的利息收入、策略投資帳面價值的調整以及較低的有效稅率所推動的。

In the quarter, we generated $68 million of operating cash flow and ended June with just over $1 billion of cash in marketable securities. Our top priority for cash remains supporting organic growth initiatives and strengthening our intellectual property advantage.

本季度，我們產生了 6,800 萬美元的營運現金流，截至 6 月底，有價證券現金略高於 10 億美元。我們現金的首要任務仍然是支持有機成長計劃和加強我們的智慧財產權優勢。

In terms of guidance, keep in mind that our fiscal year experiences seasonality. Our Q2 is usually a slow quarter for all cardiovascular devices due to a summertime slowdown in the cath lab. We expect Q2 revenue to be in the range of 12% to 14% on a constant currency basis. This translates to a modest decline from our Q1 record revenue performance of $277 million, primarily due to a $2 million to $3 million of sequential FX headwinds at current rates. In addition, we anticipate this summer quarter to be impacted by extended vacation from physicians, nurses and our workforce, coupled with ongoing hospital labor shortages.

在指導方面，請記住我們的財政年度具有季節性。由於夏季導管實驗室的放緩，我們的第二季度通常是所有心血管設備的緩慢季度。我們預計第二季營收以固定匯率計算將在 12% 至 14% 之間。這意味著我們第一季創紀錄的 2.77 億美元收入表現略有下降，這主要是由於以當前匯率計算連續 200 萬至 300 萬美元的外匯逆風所致。此外，我們預計今年夏季季度將受到醫生、護士和員工假期延長以及醫院勞動力持續短缺的影響。

As we transition to the back half of the year, we typically expect to see sequential lift in Q3 based on increased hospital activity and physician engagement. And as we finish the fiscal year, our March quarter, we expect to deliver our best results. As noted in this morning's earnings release, we are maintaining our full year constant currency revenue guidance of 13% to 17% growth. At current FX rates, we now expect reported growth rates to be 10% to 14% for the fiscal year. This guidance continues to assume that COVID moves more to an endemic state and that future waves do not have a material impact on the business and hospital labor shortages begin to moderate as we move into the second half of the year. We are also maintaining our full year operating margin guidance of 23% to 24%.

當我們過渡到今年下半年時，我們通常預計，由於醫院活動和醫生參與度的增加，第三季的業績將持續成長。當我們完成本財年（即三月季度）時，我們預計將取得最好的業績。正如今天上午的財報中所指出的，我們維持全年 13% 至 17% 成長的固定貨幣收入指引。依照目前的匯率，我們預期本財年的成長率為 10% 至 14%。本指南繼續假設新冠疫情將進一步發展為流行狀態，並且未來的浪潮不會對業務產生重大影響，隨著進入今年下半年，醫院勞動力短缺情況開始緩解。我們也維持 23% 至 24% 的全年營業利潤率指引。

In summary, we delivered a strong first quarter through disciplined execution of our Abiomed 2.0 playbook despite the challenging environment. We remain focused on executing our fiscal year '23 goals on innovation, clinical evidence and commercial excellence as we continue to build the new field of heart recovery.

總而言之，儘管環境充滿挑戰，但透過嚴格執行 Abiomed 2.0 手冊，我們在第一季取得了強勁的業績。隨著我們繼續打造心臟復健的新領域，我們仍然專注於執行 23 財年在創新、臨床證據和商業卓越方面的目標。

Operator, please now open the line for questions.

接線員，現在請撥打電話提問。

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

（操作員說明）您的第一個問題來自瑪格麗特·卡佐爾（Margaret Kaczor）與威廉·布萊爾（William Blair）的對話。

This is Brandon on for Margaret. Just looking towards this fiscal 2023 was really encouraging, great results and able to really hold that guide. A lot of the medical device peers are kind of seeing a slower recovery than they would have starting the year. So curious if you guys have any comments on that? And kind of what's sticking out for you guys that's allowing you to hold that guide and giving you confidence in that guide despite what seems like a slightly slower recovery than much of the industry is seeing?

這是瑪格麗特的布蘭登。展望 2023 財年確實令人鼓舞，取得了巨大的成果，並且能夠真正保持這項指導方針。許多醫療器械同行的復甦速度比年初慢。很好奇你們對此有何評論？對你們來說，是什麼讓你們能夠持有這份指南並讓你們對這份指南充滿信心，儘管復甦似乎比大多數行業所看到的要慢一些？

Brandon, this is Mike. Thanks for the question. Our forecast put a little bit of an opportunity for things to happen, good and bad. I think most people were surprised a little bit with the contrast media shortage. It definitely impacted a little bit of our revenue as well. But we are, as a business, have an elective business with high-risk PCI, but we also have an emergency business. And as you can see from Q1, we're double-digit growth because of our emergency patients in the cath lab and surgical suite. And we are confident high-risk PCI is going to come back, and it always does, and that will be further upside.

布蘭登，這是麥克。謝謝你的提問。我們的預測為事情的發生提供了一點機會，無論是好的還是壞的。我認為大多數人對造影劑短缺感到有點驚訝。這肯定也影響了我們的一點收入。但作為一家企業，我們有高風險 PCI 的選擇性業務，但我們也有緊急業務。正如您從第一季看到的那樣，由於導管實驗室和手術室的急診患者，我們實現了兩位數的成長。我們相信高風險 PCI 將會捲土重來，而且總是如此，而且這將帶來進一步的上漲。

But what's also exciting for us and for the year is every quarter that goes by this fiscal year, we get closer to more launches, more new products and more clinical data. So the RPIJ will be available by the end of our fiscal year, will be a new product for surgeons for right heart failure. We're excited to launch the LP Sheath. To remind everyone, this is a smaller sheath that's compatible with single access. It's going to reduce the hole by a French 1.5. I think it's going to be very helpful for high-risk PCI and overall shock patients treated in a cath lab. We know access is a big issue for people, and we're very positive and excited to have that product in the U.S. market.

但對我們來說，今年也令人興奮的是，在本財年的每個季度，我們都更接近更多的上市、更多的新產品和更多的臨床數據。因此，RPIJ 將在我們財政年度結束時上市，並將成為外科醫生治療右心衰竭的新產品。我們很高興推出 LP 護套。提醒大家，這是一個較小的護套，與單通道相容。它將把洞減少法國 1.5。我認為這對在導管實驗室治療的高風險 PCI 和整體休克患者非常有幫助。我們知道獲取對人們來說是一個大問題，我們非常積極和興奮地將該產品推向美國市場。

We're going to have our Breethe launch at the end of the year. So again, this is probably one of the best devices for ambulation. It's the smallest, it's the size of basically a briefcase and we're very confident in the blood compatibility and durability. We did do our second patient on BTR during this quarter, but we're going to have more progress on that. And hopefully, through the EFS, we'll be able to start generating revenue with reimbursement as a category B by the end of the year.

我們將在今年底推出 Breethe。再說一次，這可能是最好的行走設備之一。它是最小的，基本上只有公文包大小，我們對血液相容性和耐用性非常有信心。本季我們確實在 BTR 上治療了第二位患者，但我們將在這方面取得更多進展。希望透過 EFS，我們能夠在今年年底前開始透過 B 類報銷來產生收入。

And of course, we're taking the opportunity right now for the IRBs and the administrative legal contracts to continue to enroll in ECP because we're in the pivotal protocol. And we're going to make enhancements as we go forward. So we feel like we're in a very good place going into Q2 and very confident in the year not just because of the clinical data, but also the new innovation coming.

當然，我們現在正在利用 IRB 和行政法律合約的機會繼續加入 ECP，因為我們處於關鍵協議中。我們將在前進的過程中進行改進。因此，我們覺得進入第二季度我們處於一個非常好的位置，並且對今年非常有信心，不僅因為臨床數據，而且因為即將到來的新創新。

And just as looking in the surgery side and 5.5, I mean those 2 continue to put up great growth numbers despite what's getting a larger business and the comps keep getting a little bit harder. Can you just talk about what's driving the underlying momentum there? Where is growth coming from? Is it coming from new accounts? Is it coming from going deeper into existing accounts? Maybe it's a little bit of both. But what are we -- what can we expect from that -- those 2 products or product in that segment and how should they trend through the rest of the year?

就像手術方面和 5.5 一樣，我的意思是，儘管業務規模不斷擴大，而且競爭變得越來越困難，但這兩家公司仍繼續呈現巨大的成長數字。您能談談是什麼推動了那裡的潛在動力嗎？成長從哪裡來？是來自新帳戶嗎？它來自於對現有帳戶的深入研究嗎？也許兩者兼而有之。但是我們是什麼——我們能從中期待什麼——這兩種產品或該細分市場的產品以及它們在今年剩餘時間裡的趨勢如何？

Great. Thanks. So there's a population out there that's not AMI shock, but chronic heart failure shock or acutely decompensating heart failure shock. So these are the frequent flyers then and what's happened is the Impella 5.5 has become the go-to product. So you have these 7-year-olds coming in, they're not -- they didn't take their inotropes or their diet's off and they're decompensating. And this gives the surgeon the ability to put something in minimally invasively through the axillary. So less than an hour, patients can get up and walk around. The device has sensors, and they can get these patients back to what's baseline or acute recovery while protecting the heart, unloading it and giving renal perfusion to the kidneys.

偉大的。謝謝。因此，有一部分不是 AMI 休克，而是慢性心臟衰竭休克或急性失代償性心臟衰竭休克。這些都是常旅客，而 Impella 5.5 已成為首選產品。所以這些 7 歲的孩子進來了，他們沒有——他們沒有服用正性肌力藥，也沒有停止飲食，他們正在失代償。這使得外科醫生能夠透過腋窩微創地放置一些東西。這樣不到一個小時，病人就可以起身走動了。該設備配有感測器，可讓這些患者恢復到基線或急性恢復，同時保護心臟、減輕心臟負荷並向腎臟提供腎臟灌注。

So it's really been a great product. It is a revolutionary product because now you have a minimally invasive weanable heart pump. All prior heart pumps required a sternotomy, and then you have to core out the apex of the heart, and then you bypass the blood out of the heart right to the aorta. So it's not ideal for older patients or patients that want recovery.

所以這確實是一個很棒的產品。這是一款革命性的產品，因為現在您擁有了一台微創可脫機心臟幫浦。以前所有的心臟幫浦都需要進行胸骨切開術，然後必須將心臟的心尖掏空，然後將血液從心臟引流到主動脈。因此，對於老年患者或想要康復的患者來說，這並不理想。

For your question of where the volume is coming, it's more patients, it's more centers. The device does run longer. In the engineering bay, it runs extensive periods of time. And it really has transformed heart failure in the heart team to try to recover these chronic patients and protect their kidneys. I would encourage all investors to watch Dr. David D'Alessandro and Dr. Jane Wilcox, both from Northwestern and Mass General because they really go deeper in that question, and they show some live cases. So I hope everyone has the opportunity to see that.

對於您提出的問題，即數量將來自哪裡，更多的患者，更多的中心。該設備確實運行時間更長。在工程區，它運行很長一段時間。它確實改變了心臟團隊的心臟衰竭，試圖讓這些慢性病患者康復並保護他們的腎臟。我鼓勵所有投資者觀看來自西北大學和麻省總醫院的大衛·達歷山德羅博士和簡·威爾科克斯博士，因為他們確實對這個問題進行了更深入的探討，並且展示了一些真實案例。所以我希望每個人都有機會看到這一點。

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

您的下一個問題來自 BTIG 的 Marie Thibault。

I wanted to start here with a quick question on sort of the contrast media shortage impact. I wonder if you could size that for us, quantify it for us? And where it is now? Do you feel that it's been fully resolved with most of your centers?

我想先問一個關於造影劑短缺影響的快速問題。我想知道您是否可以為我們確定其規模，為我們量化？現在它在哪裡？您認為您的大多數中心都已完全解決這個問題嗎？

Thanks, Marie, for the question. As we talked about each quarter, we've had a positive evolution of our customer base during COVID because the smaller hospitals had to pick up more of the work relative to emergency patients and also even the high-risk PCI. And we -- that's how we're able to maintain positive growth during the first year of COVID. That trend has been continuing.

謝謝瑪麗提出的問題。正如我們每季談到的那樣，在新冠疫情期間，我們的客戶群有了積極的發展，因為較小的醫院必須承擔更多與急診患者甚至高風險 PCI 相關的工作。這就是我們在新冠疫情第一年保持正成長的方式。這種趨勢一直持續著。

However, what we saw in the quarter was that the smaller centers didn't have access to the contrast. And that's what potentially impacted a little bit of our high-risk PCI. Todd can give the numbers on it, whereas the bigger centers had access. So it was spotty. It was all over the U.S. And we believe that the majority of that is behind us. But certainly, we're going to continue to monitor the situation. Todd, do you want to comment on the numbers?

然而，我們在本季看到的是較小的中心無法獲得對比。這可能會對我們的高風險 PCI 產生一些影響。托德可以提供上面的數字，而更大的中心可以訪問。所以它是參差不齊的。它遍布美國，我們相信其中大部分已經過去了。但當然，我們將繼續關注事態發展。托德，你想對這些數字發表評論嗎？

Yes. So Marie, to the best of our ability, we think it's somewhere around 150 plus or minus a few, but 150 patients in the quarter, which obviously would have impacted our overall patient growth by about 2 points. And as Mike mentioned, it mostly occurred in our high-risk PCI business. And so again, if you think about what we reported, that's an additional 150 patients, it's worth about 5 points of growth on high-risk PCI. So that's -- to the best of our ability, that's how -- what we came up with as the impact from contrast media in Q1. And as Mike mentioned, it was mostly at the smaller hospitals.

是的。因此，瑪麗，盡我們所能，我們認為本季度大約有 150 名左右的患者，加上或減去一些，但 150 名患者，這顯然會影響我們的整體患者增長約 2 個百分點。正如 Mike 所提到的，這主要發生在我們的高風險 PCI 業務中。再說一次，如果你考慮我們報告的內容，那就是額外的 150 名患者，值得高風險 PCI 成長約 5 個百分點。這就是我們盡我們所能得出的第一季對比媒體的影響。正如麥克所提到的，主要是在較小的醫院。

Wow, that's really great detail. And then here, my follow-up, I wanted to talk a little bit about your operating spend. You've had some very nice control on R&D. And I think I heard that your manufacturing -- you're investing in manufacturing and adding sales head count. So I wanted to hear a little bit more about where those new sales reps are going to be focused? What areas you're expanding capacity, manufacturing capacity and how you achieve some of that R&D control?

哇，這真是太詳細了。然後在這裡，我的後續行動，我想談談您的營運支出。你們對研發有一些非常好的控制。我想我聽說你們的製造業——你們正在投資製造業並增加銷售人員數量。所以我想更多地了解這些新銷售代表將重點放在哪些領域？您正在哪些領域擴大產能、製造能力以及如何實現部分研發控制？

Yes. So Marie, in terms of sales heads for the quarter, I think it was somewhere in that 18, 19 heads. We continue to, I would say, invest more on the surgical account team, just given where we are from a penetration standpoint. We're at 440 hospitals out of the 1,100. So that's really where, I would say, some of our investment went on the commercial team. We are still, I would say, looking to potentially go to a few more regions, a few more franchises. And again, that boded well for us during COVID as you know, that we grew smaller hospitals at a faster clip just because we had more feet on the ground.

是的。所以瑪麗，就本季的銷售頭而言，我認為是在 18、19 個頭中的某個地方。我想說，考慮到我們從滲透率的角度來看，我們將繼續對手術客戶團隊進行更多投資。我們在 1,100 家醫院中的 440 家提供服務。所以我想說，這確實是我們對商業團隊的一些投資。我想說，我們仍然希望有可能進入更多的地區、更多的特許經營權。再說一次，這對我們來說是個好兆頭，正如你們所知，在新冠疫情期間，我們以更快的速度發展了更小的醫院，只是因為我們有更多的腳踏實地。

With regards to gross margin, it's 81% in the quarter. Again, we are adding a little bit more, I would say, on the hourly workers as we think about ramping up our volume in the second half of the year.

毛利率方面，本季為 81%。我想說，當我們考慮在今年下半年增加產量時，我們會再增加一點小時工。

Your next question comes from the line of Pito Chickering with Deutsche Bank.

您的下一個問題來自德意志銀行的 Pito Chickering。

Can we sort of talk about the Impella ECP trials for a minute, get some updated enrollment numbers there, if possible? And then from a product perspective, any major revisions to either hardware, software during the quarter?

我們能否稍微討論一下 Impella ECP 試驗，如果可能的話，取得一些更新的註冊人數？然後從產品的角度來看，本季硬體、軟體是否有重大修改？

Sure, Peter. This is Mike. Thanks for the question. On the ECP, we've closed out the early feasibility protocol. And in March, we had the pivotal protocol approved. So we're continuing to enroll patients. We're collecting all that data. We're going to utilize all that data in our submission. The IRB process and the legal administrative work at hospitals across the board for those that don't follow this is a lot more complicated and at a best, it's a 3-month and at norm, it can be 6 months.

當然，彼得。這是麥克。謝謝你的提問。在 ECP 上，我們已經完成了早期可行性協議。三月份，我們批准了關鍵協議。所以我們正在繼續招募患者。我們正在收集所有這些數據。我們將在提交的內容中使用所有這些數據。對於那些不遵循這項規定的醫院來說，IRB 流程和醫院的法律行政工作要複雜得多，最多需要 3 個月，正常情況下可能需要 6 個月。

So as we're working through that, we have 3 IRBs approved, but we don't have a single site that has approved the site activity. We are making -- taking the opportunity to make a few enhancements that we'll continue to make on the product and we'll do that throughout the pivotal. So that's -- that part will happen. That's the benefit of doing this early feasibility. That's also the benefit of working with the FDA on something that has, again, breakthrough designation status as a product.

因此，當我們正在解決這個問題時，我們已經批准了 3 個 IRB，但我們沒有一個站點批准了站點活動。我們正在利用這個機會對產品進行一些改進，我們將繼續對產品進行改進，並且我們將在整個關鍵過程中這樣做。所以這部分將會發生。這就是進行早期可行性研究的好處。這也是與 FDA 合作開發具有突破性產品指定地位的產品的好處。

Okay. Great. And then Europe and Japan show very strong growth year-over-year and actually accelerated sequentially. Just curious is there some more details on those markets and what do you assume within your guidance for the rest of the year?

好的。偉大的。然後歐洲和日本的同比增長非常強勁，而且實際上是連續加速的。只是好奇是否有關於這些市場的更多細節以及您對今年剩餘時間的指導有何假設？

Yes. The Japan market is ideal for our focus around native heart recovery. By providing now the Impella 5.5, we allow the heart surgeons to have a longer-term pump, a device that in the engineering base gets run over a year. The Japan protocol is they tend to keep their patients in the hospital. And with their focus on myocardial recovery and stem cells, we are going to be coordinating and partnering with those institutions where we'll do extended unloading with 5.5, which we know immediately shrinks the left ventricular geography or geometry of the left ventricle. We know we get -- we rest the heart. We also know we get renal perfusion.

是的。日本市場是我們專注於本土心臟復健的理想市場。透過現在提供 Impella 5.5，我們讓心臟外科醫生能夠擁有一台長期使用的泵，該設備在工程基礎上可以運行一年以上。日本的做法是他們傾向於將病人留在醫院。由於他們專注於心肌恢復和幹細胞，我們將與那些機構進行協調和合作，在這些機構中我們將使用 5.5 進行延長卸載，我們知道這會立即縮小左心室的地理或左心室的幾何形狀。我們知道我們得到了——我們讓心得到休息。我們也知道我們得到了腎臟灌注。

So we're going to be doing continued advanced protocols now for getting back these chronic patients. And the society and the physician community there is very excited about this (inaudible) research. And we'll be there in October, I'll be there in October. And we're out, again, traveling. The shows are up and running. And so we're in Japan, we're in Germany, and we're all over the U.S. and progress and the research is moving forward.

因此，我們現在將繼續實施先進的方案來讓這些慢性病患者康復。那裡的社會和醫生界對這項（聽不清楚）研究感到非常興奮。我們將在十月到達那裡，我也會在十月到達那裡。我們又出去旅行了。演出已經開始並正在運行。所以我們在日本、在德國、在美國各地，研究正在取得進展。

Your next question comes from the line of Chris Pasquale with Nephron Research.

您的下一個問題來自 Nephron Research 的 Chris Pasquale。

Congrats on getting RECOVER IV approved and making some nice progress on the other studies this quarter. That's great to see. Mike, it's been challenging to do randomized trials in cardiogenic shock, and prior attempts have ended up with some messy data. I see that you got an exception from informed consent, which should help with enrollment. But are there other things you've done with the design of this trial to ensure that you end up with a well-balanced trial and a clean look at the clinical value of Impella in that population?

恭喜 RECOVER IV 獲得批准，並在本季度的其他研究中取得了一些良好進展。很高興看到這一點。麥克，在心因性休克中進行隨機試驗一直具有挑戰性，而先前的嘗試最終得到了一些混亂的數據。我發現您獲得了知情同意的例外情況，這應該有助於註冊。但是，您在設計本試驗時是否還做了其他事情，以確保您最終獲得平衡良好的試驗並清楚地了解 Impella 在該族群中的臨床價值？

Sure, Chris. So the Abiomed has attempted all of the cardiogenic shock studies in this space. In 2008, 2009, we did RECOVER II in the U.S. And as you mentioned, we're only able to enroll 1 patient that was based on the ethical logistical challenges back when people thought the balloon pump did more flow. In Europe, they've been able to consent these patients because they do have an exception. They can have 2 physicians make a decision where they don't have to go to somebody getting CPR or find a family member to consent the patient. That was the CULPRIT study that showed that mortality is 50% when you don't have a protocol in place and you try to bail these patients out.

當然，克里斯。因此，Abiomed 嘗試了該領域的所有心因性休克研究。 2008 年和 2009 年，我們在美國進行了 RECOVER II。在歐洲，他們能夠同意這些患者，因為他們確實有例外。他們可以讓 2 名醫生做出決定，而無需去找接受心肺復甦術的人或找家人同意患者。罪魁禍首研究表明，當你沒有製定適當的方案並試圖救助這些患者時，死亡率為 50%。

And it was also the SHOCK II study, which was published in the New England Journal of Medicine, that was a balloon pump. And that showed the balloon pump not only had zero benefit in clinical outcomes, it did not even improve the hemodynamics because the hemodynamics for the balloon pump is generated by inotropic drugs, which work, but they work the heart harder and they also cause arrhythmias, which makes a balloon pump not working almost detrimental and dangerous.

發表在《新英格蘭醫學雜誌》上的 SHOCK II 研究就是氣球幫浦。這表明球囊幫浦不僅對臨床結果沒有好處，甚至沒有改善血流動力學，因為球囊幫浦的血流動力學是由正性肌力藥物產生的，這種藥物有效，但它們會加重心臟負擔，也會導致心律不整，這使得氣球泵不工作幾乎是有害和危險的。

So now we've tried IMPRESS. We tried multiple times in Europe. We tried the (inaudible). All of those studies started with the concept of randomization. None of those studies were actually randomized. Because as they got further into the study, the physicians felt it was unethical or the consent was too difficult. So they just started -- they would -- they've ended up not being -- they're not randomized studies despite the fact that some of the authors of certain publications say they are. They're not -- there are studies we funded them.

所以現在我們嘗試了 IMPRESS。我們在歐洲嘗試過多次。我們嘗試了（聽不清楚）。所有這些研究都是從隨機化的概念開始的。這些研究其實都不是隨機的。因為隨著研究的深入，醫生們覺得這是不道德的，或者同意太困難了。所以他們剛開始——他們會——他們最終沒有——他們不是隨機研究，儘管某些出版物的一些作者說他們是隨機研究。他們不是——我們資助了一些研究。

So we went to the FDA, and we've been working with them now for 1.5 years, 2 years. They are the authority on these -- on what's called EFIC exception for informed consent. They are the ruling body as far as an authority. They work with us to get that step that they can now consider patients in cardiogenic shock can utilize the EFIC channel. However, we still need the local IRBs to approve it. And we also need the physicians to do it. We recognize not all physicians will randomize these patients. However, they're the leaders in the space, the published leaders in the space, the ones that treat these patients have developed this best practice protocol, which they've also published and they want to pursue this study.

所以我們去了FDA，現在已經和他們合作了1.5年、2年了。他們是這些方面的權威——所謂的 EFIC 知情同意例外。就權威而言，他們是統治機構。他們與我們合作，現在可以考慮心因性休克患者可以使用 EFIC 通道。然而，我們仍然需要當地IRB 的批准。我們還需要醫生來做這件事。我們認識到並非所有醫生都會對這些患者進行隨機分組。然而，他們是該領域的領導者，該領域已發表的領導者，治療這些患者的人已經制定了這個最佳實踐方案，他們也已經發表了該方案，並且他們希望繼續這項研究。

And what's new is that a lot of these centers, some of them use ECMO as first pass as the way they treat shock, not just oxygenation. So in the other arm, they'll have the option to do ECMO, anyone's ECMO. It will actually be the first study ever done with the FDA that will measure the adverse events of ECMO and ECMO has life-saving components to it and it oxidases the body, but it's not ideal for cardiogenic shock where you have a hemodynamic problem and actually can cause other issues. So that will be in the other arm. Oxygenation will be a protocol.

新鮮的是，許多這樣的中心，其中一些中心使用 ECMO 作為治療休克的第一道關卡，而不僅僅是氧合。因此，在另一隻手臂中，他們可以選擇進行 ECMO，任何人的 ECMO。這實際上是FDA 進行的第一項研究，旨在測量ECMO 的不良事件，ECMO 具有挽救生命的成分，並且會氧化身體，但對於存在血流動力學問題的心源性休克來說，它並不理想，而且實際上可能會導致其他問題。所以那將在另一隻手臂上。氧合將成為一個方案。

And really, the customer base will determine with RECOVER IV their ability to randomize, their ability to execute. And this is where all of these other studies that we've been doing around pre-PCI. We feel like we have the formula for success. This best practice protocol on Impella for shock of identifying shock really putting Impella in before the PCI, looking for right heart failure and monitoring hemodynamics has now been published and duplicated over a decade. So we're excited to do RECOVER IV.

事實上，客戶群將透過 RECOVER IV 決定他們的隨機化能力和執行能力。這就是我們圍繞 PCI 之前所做的所有其他研究的範圍。我們覺得我們擁有成功的秘訣。這項用於識別休克的 Impella 休克最佳實踐方案確實將 Impella 置於 PCI 之前，尋找右心衰竭並監測血流動力學，現已出版並複製了十多年。所以我們很高興能夠進行 RECOVER IV。

If I remember correctly, one of the issues with IMPRESS was also that a lot of patients who got enrolled already had some evidence of brain injury at admission. So we're getting to them too late. Is there anything to deal with that issue and try and make sure that these patients still have a chance at the time they're getting support?

如果我沒記錯的話，IMPRESS 的問題之一是許多入組的患者在入院時已經有一些腦損傷的證據。所以我們來得太晚了。有什麼辦法可以解決這個問題並嘗試確保這些患者在獲得支持時仍然有機會嗎？

Sure. So there were 48 patients, 24 of the patients got Impella. The majority of those patients, only 4 got Impella before the PCI, 4 out of the 5 lived. So we have an 80% survival in the IMPRESS. Unfortunately, they stopped randomizing. 15 patients within the 48 were not randomized and were not sequential. And more than half of these patients were in cardiac arrest, which is not ideal that this is not a cardiac arrest pump. And many of them got randomized after they had done the PCI and even had a balloon pump in.

當然。有 48 名患者，其中 24 名患者接受了 Impella。大多數患者中，只有 4 例在 PCI 前接受了 Impella，5 例中有 4 例存活。所以我們在 IMPRESS 中的存活率是 80%。不幸的是，他們停止了隨機化。 48 名患者中的 15 名患者未進行隨機分組，也未進行序貫研究。而且這些患者中有一半以上處於心臟驟停狀態，這不是心臟驟停泵，這並不理想。他們中的許多人在完成 PCI 後被隨機分配，甚至接受了球囊泵。

So that IMPRESS and severe shock is really cardiac arrest. The original IMPRESS that we only did 18 patients was that protocol, and we're looking to rule out cardiac arrest from the study. They will not be in the RECOVER IV protocol. And as you know, Chris, there's a range of mortality in shock and the society, interventional cardiologist guy has a class from A through E. Then you can have a range of mortality at 3% in E and you can have an 85% mortality rate in Stage E. So it really is that metric. And that's one of the challenges with these databases that they -- when people write a [paper on] data from 7 years ago, is the balloon pump arm is biased because the patients that get sick on the balloon pump come out, either they will go to ECMO and are ignored.

因此，印象深刻和嚴重的休克實際上是心臟驟停。最初印像中我們只對 18 名患者進行了研究，我們希望從研究中排除心臟驟停的情況。它們不會出現在 RECOVER IV 協定中。如你所知，克里斯，休克和社會上有一系列的死亡率，介入心臟病專家有從A 到E 的等級。率E 階段的比率。這就是這些資料庫面臨的挑戰之一，當人們寫一篇關於 7 年前的數據的論文時，球囊泵臂是有偏見的，因為使用球囊泵生病的患者要么會出來，要么他們會去ECMO 並被忽略。

In ECMO, you'll notice is not in these analysis by people that are pulling databases or they go into the Impella arm. And they're now in the Impella arm but they don't disclose that. And it also includes balloon pump patients that get [bailed] out in the Impella arms. So we have all the data. The world's experts are writing our papers and our protocols, they're one to treat that, but to the folks that want to put out databases, we encourage them to publish their own data and come join our studies and randomize.

在 ECMO 中，您會注意到這些分析中並不存在提取資料庫或進入 Impella 部門的人員。他們現在隸屬於 Impella 部門，但他們沒有透露這一點。它還包括透過 Impella 臂[保釋]出來的球囊泵患者。所以我們擁有所有數據。世界各地的專家正在撰寫我們的論文和協議，他們是解決這個問題的專家，但對於那些想要發布資料庫的人，我們鼓勵他們發布自己的數據並加入我們的研究和隨機化。

Your next question comes from the line of Matt O'Brien with Piper Sandler.

你的下一個問題來自馬特·奧布萊恩和派珀·桑德勒的對話。

Just for starters, Mike, to put a finer point on 5.5, I mean that was a meaningful acceleration sequentially with that product. You've talked a little bit about centers and utilization, but can you just put a finer point on what you're seeing as far as some of the centers that have been using 5.5 for maybe a year now as far as their trends? And then are these new systems and centers that are coming on, are they adapting even faster just based on what some of the other centers are seeing as far as outcomes?

首先，Mike，為了對 5.5 進行更詳細的闡述，我的意思是，對於該產品來說，這是一個有意義的連續加速。您已經談論了一些關於中心和利用率的問題，但是您能否更詳細地說明一下您所看到的一些中心的情況，這些中心已經使用 5.5 大約一年了，就其趨勢而言？那麼，這些即將出現的新系統和中心是否會根據其他一些中心所看到的結果而更快地適應？

Yes. Thanks for the question. I guess the best way I'd answer that is encourage everyone to watch the webcast we did with the experts because they go into detail and show some of the examples of why they now use 5.5, whereas in the past they might have done lots of either inotropes or considered patients for LVADs or transplant. I do think you pointed out, it's still growing. And what's most gratifying to see is that with the volume you're also seeing the high survival rates, high recovery rates are being maintained.

是的。謝謝你的提問。我想我回答的最好方法是鼓勵每個人觀看我們與專家一起進行的網路廣播，因為他們詳細介紹並展示了一些示例來說明為什麼他們現在使用 5.5，而在過去他們可能做了很多工作要么是正性肌力藥，要嘛是考慮接受LVAD 或移植的患者。我確實認為你指出了，它仍在增長。最令人欣慰的是，隨著數量的增加，您還看到了高存活率和高康復率。

I believe the Impella 5.5 is a full VAD. It has as good a flow or better flow than all the other VADs from the past because it's forward flow. And it really does now add to the ability not just to get the patient often better and wean the heart, but we routinely see now patients that have bad kidneys come back, the kidneys recover. And what's also interesting is patients that don't get better, that their cardiomyopathy is to advance, we do see them listed for heart and kidney transplant. And during the 2- to 4-week weight, we see the kidneys also come back. So now these patients are just getting a heart transplant, and they don't require a kidney transplant.

我相信 Impella 5.5 是一台完整的 VAD。它具有與過去所有其他 VAD 一樣好的流量或更好的流量，因為它是前向流量。現在，它確實增強了這種能力，不僅可以讓患者病情好轉，讓心臟斷奶，而且我們現在經常看到腎臟不好的患者康復，腎臟恢復。同樣有趣的是，那些沒有好轉的患者，他們的心肌病變正在惡化，我們確實看到他們被列入心臟和腎臟移植的名單。在 2 到 4 週的體重期間，我們看到腎臟也恢復了。所以現在這些病人只是進行心臟移植，不需要腎臟移植。

So there's more research and clinical data to come but it's clearly a breakthrough product. And again, for those that have covered the LVAD space, there's not anything in the world like the Impella 5.5, a minimally invasive weanable forward flow heart pump. And it's really -- it's a great tool for the heart surgeons, especially with the emergency population today that they don't know what to do, that's one of the biggest admissions into the hospitals.

因此，還有更多的研究和臨床數據出現，但它顯然是一個突破性的產品。再說一次，對於已經了解 LVAD 領域的人來說，世界上沒有什麼比 Impella 5.5 更好的了，這是一款微創可脫機正向流心臟幫浦。對於心臟外科醫生來說，這確實是一個很好的工具，特別是對於今天的急診人群，他們不知道該怎麼辦，這是醫院入院人數最多的情況之一。

Got it. And then just wanted to put another finer point on ECP. I think you've got the pivotal study going, did the EFS as well. I think collectively because you can include those EFS patients in the pivotal. So you're up to 31 patients total. Just want to make sure that's right. And then you're making some tweaks to the product, there's no delay in the product. You're still expecting kind of just the same time lines as you were expecting before? Is there -- I just want to make sure that, that's clear.

知道了。然後我想對 ECP 提出另一個更詳細的觀點。我認為您已經進行了關鍵研究，也進行了 EFS。我認為是集體的，因為你可以將那些 EFS 患者納入關鍵中。所以總共有 31 位患者。只是想確保這是正確的。然後你對產品進行一些調整，產品沒有任何延遲。您仍然期待與之前相同的時間線嗎？有嗎——我只是想確保這一點，這是明確的。

Yes. Thanks for the questions to clarify ECP. So the EFS study closed out after 26 patients. In March, we got the IDE pivotal protocol approved. So we're now collecting data on ECP using the pivotal protocol. While we're getting all the centers up for IRB and the legal activity site contracting, we are making some enhancements, but we're still collecting data, and we did 5 cases in Q1. And that data is under the pivotal protocol. So we'll absolutely be utilizing that. Remember, it's a single-arm study up to 217 patients. And what we're trying to show is it's as safe (inaudible) PCI as the Impella 2.5 and CP that we have data from the PROTECT II and PROTECT III.

是的。感謝您提出問題來澄清 ECP。因此，EFS 研究在 26 名患者參與後結束。 3 月份，我們獲得了 IDE 關鍵協議的批准。因此，我們現在正在使用關鍵協議收集 ECP 數據。雖然我們正在為所有中心建立 IRB 和法律活動網站承包，但我們仍在進行一些改進，但我們仍在收集數據，我們在第一季處理了 5 個案例。這些數據是在關鍵協議下的。所以我們絕對會利用它。請記住，這是一項最多 217 名患者參與的單臂研究。我們試圖展示的是它與 Impella 2.5 和 CP 一樣安全（聽不清楚） PCI，我們從 PROTECT II 和 PROTECT III 獲得了數據。

Your next question comes from the line of Mike Polark with Wolfe Research.

您的下一個問題來自 Wolfe Research 的 Mike Polark。

I will follow up on that. The enhancements, Mike, can you just maybe shed a little more light on what that means, what enhancements are being made? And how significant or not are they for the ECP product?

我會跟進此事。麥克，您能否進一步說明增強功能的含義以及正在進行哪些增強功能？它們對於 ECP 產品有多重要？

Well, we're -- we make constant enhancements, Mike, and for competitive reasons and all the things we're doing, we don't disclose those. But we've been making enhancements and improvements on the products since the very first patient over a year ago. One of the benefits of being in an early feasibility study is that gives you that flexibility. The other benefit of having a breakthrough designation is that you can make these enhancements as you go. We're confident in the enhancements that are lined out and -- but we're always going -- and we'll continue to make enhancements as we go through the study and we'll continue to file more patents around everything we do.

好吧，麥克，我們不斷進行改進，出於競爭原因以及我們正在做的所有事情，我們不會透露這些。但自從一年多前第一個患者出現以來，我們一直在對產品進行增強和改進。參與早期可行性研究的好處之一是為您提供靈活性。擁有突破性頭銜的另一個好處是您可以隨時進行這些增強。我們對所列出的增強功能充滿信心，並且我們將始終堅持下去，並且我們將在研究過程中繼續進行增強功能，並且我們將繼續圍繞我們所做的一切申請更多專利。

If I can for my follow-up ask on 5.5 and just kind of center activations in the U.S., 440 round numbers centers in the June quarter. We have the data you've provided in the past on 5.0 is in 660 centers, but there's 1,100 surgical suites in the U.S. I guess, as you roll this forward over the next couple of years and continue to commercialize 5.5. And -- will the kind of center network stop at the 5.0 level? Or do you think there's a good chance that you're in more centers eventually with 5.5 than you were on 5.0?

如果我可以跟進詢問美國的 5.5 個中心激活情況，那麼 6 月季度將有 440 個中心。我們有您過去提供的 5.0 數據，分佈在 660 個中心，但我猜美國有 1,100 個手術室，隨著您在未來幾年內推進這項工作並繼續將 5.5 商業化。還有──那種中心網絡會停留在5.0的水平嗎？還是你認為最終 5.5 的中心很可能比 5.0 的中心更多？

Yes, Mike, this is Todd. I'll just -- I'll answer that one. In terms of the 5.0 sites, if you just went back and looked at the last several quarters, we really haven't opened up many 5.0 sites. Every new site we open up now is going to be with 5.5. And so if you just went back and looked at the last 3 or 4 quarters, we've been averaging somewhere between 45 and 50 site openings for 5.5. And I think that should continue, I think, in the next several quarters, that cadence. So I don't think you're going to see us opening many more sites with 5.0, it's just going to be more going forward with 5.5. And again, we have 1,100 hospitals with surgical suites in the U.S. We have a long runway of growth ahead of us just with the 5.5.

是的，麥克，這是托德。我只是——我會回答這個問題。就5.0網站而言，如果你回頭看看過去幾個季度，我們確實沒有開放很多5.0網站。我們現在打開的每個新站點都將使用 5.5。因此，如果你回頭看看過去 3 或 4 個季度，我們平均 45 到 50 個網站空缺職位為 5.5 個。我認為，在接下來的幾個季度裡，這種節奏應該會繼續下去。因此，我認為您不會看到我們在 5.0 中打開更多網站，而在 5.5 中只會有更多進展。再說一次，我們在美國有 1,100 家醫院擁有手術室。

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

你的下一個問題來自傑森貝德福德和雷蒙德詹姆斯。

Just one for Todd and then a couple for Mike. Todd, on the contrast dynamic, I appreciate the detail there, but just the missed patients in 1Q, are these patients unfortunately lost? Or do you think these procedures spill into 2Q?

只給托德一份，然後給麥克幾份。托德，關於對比動態，我很欣賞那裡的細節，但只是第一季錯過的患者，這些患者是否不幸丟失了？或者您認為這些程序會蔓延到第二季嗎？

It's a great question, Jayson. I think it's something we're trying to measure ourselves. I think unfortunately, there's probably a portion of those patients that might have been staged and not obviously coming back into the cath lab, but we think a portion of them will come back at some point in time. Again, similar to what we've seen over the course of the pandemic that these patients aren't "essential" -- I mean, elective, they're essential and they need to be treated. So we do expect some of these patients to come back into the system sometime in, I'd say, Q2. The timing of it is all -- it's tough to call, but I would say there's a portion of that we expect to see to come back in to the system.

這是一個很好的問題，傑森。我認為這是我們正在嘗試衡量自己的事情。我認為不幸的是，可能有一部分患者可能已經被分期，並且沒有明顯返回導管實驗室，但我們認為其中一部分會在某個時間點回來。再一次，類似於我們在大流行過程中看到的情況，這些患者不是「必需的」——我的意思是，選擇性的，他們是必需的，需要接受治療。因此，我們確實預計其中一些患者會在第二季度的某個時候返回系統。這一切的時機是——很難說，但我想說的是，我們希望看到其中的一部分回到系統中。

Okay. And then, Mike, just on ECP, a couple of follow-ups. From the 5 patients enrolled in the pivotal protocol in 1Q, will they be included in the 217 patients needed for the trial?

好的。然後，麥克，就 ECP 而言，有一些後續行動。從第一季參與關鍵方案的 5 名患者中，他們是否會被納入試驗所需的 217 名患者中？

Yes. Remember, it's up to 217 patients. And so all the data we collect is being compared to the numbers that we know and can match on PROTECT II and PROTECT III on both Impella 2.5 and CP. And what we're comparing is 30-day MACE, but we're also looking primarily at access closure and safe-eval information. And so that's what we're working on. And we already have high-risk PCI, the indication. And we're looking to get the ECP through that process, so we can put the ECP into PROTECT IV as well as the STEMI DTU study, which is our intent.

是的。請記住，最多有 217 名患者。因此，我們收集的所有數據都與我們已知的數據進行比較，並且可以在 Impella 2.5 和 CP 上的 PROTECT II 和 PROTECT III 上進行匹配。我們比較的是 30 天的 MACE，但我們也主要關注訪問關閉和安全評估資訊。這就是我們正在努力的方向。我們已經有了高風險 PCI 的適應症。我們希望讓 ECP 通過這個過程，這樣我們就可以將 ECP 納入 PROTECT IV 以及 STEMI DTU 研究中，這就是我們的目的。

Okay. And when do you expect to enroll the first patient in the pivotal, not so much the pivotal protocol but the pivotal?

好的。您預計什麼時候在關鍵項目（不是關鍵方案而是關鍵項目）中招募第一位患者？

Yes. So the pivotal protocol is, the difference will be that the center now has IRB approval in all the site activity, but we are collecting the data that we will collect in the pivotal. And so we're -- that's the benefit of doing this procedure and having the early feasibility. So we are collecting data now that we'll be using.

是的。因此，關鍵協議是，不同之處在於該中心現在所有站點活動都獲得了 IRB 批准，但我們正在收集將在關鍵協議中收集的數據。所以我們——這就是執行此程序並具有早期可行性的好處。所以我們現在正在收集我們將要使用的數據。

Okay. I'm still just trying to reconcile the difference between the pivotal protocol and the pivotal and maybe...

好的。我仍然只是試圖協調關鍵協議和關鍵協議之間的差異，也許...

So the difference is we're utilizing the pivotal protocol approval at the existing centers that were in the early feasibility study. We're collecting the data now that was in -- that will be in the pivotal that we didn't collect in the early feasibility study. As we transition and get the site up with the IRB approval and the site activity, then that will just continue. And while we're waiting on that, we're making some enhancements to the product. We went out to 50 centers and the first 25 that can get through the process on the IRB will be in the study. But everything we're doing now, the data we're collecting will be utilized for the PMA because it is the pivotal protocol.

因此，不同之處在於我們正在利用早期可行性研究中現有中心的關鍵協議批准。我們現在正在收集的數據——這將是我們在早期可行性研究中沒有收集到的關鍵數據。當我們過渡並讓網站獲得 IRB 批准和網站活動時，這種情況就會繼續下去。在等待的同時，我們正在對產品進行一些增強。我們去了 50 個中心，最先通過 IRB 流程的 25 個中心將參與研究。但我們現在所做的一切，我們收集的數據將用於 PMA，因為它是關鍵協議。

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

你的下一個問題來自摩根士丹利的塞西莉亞·弗隆。

This is Calvin on for Cecilia. Just 2 really quick ones for me. First, just on -- particularly on your PCI side of the business, I'm just curious how meaningful of a headwind has staffing pressures -- staffing shortages been to PCI procedure volumes? Has the impact sort of intensified? Has it improved? And just what's incorporated in your reiterate outlook around staffing impact?

這是卡爾文為西西莉亞配音的節目。對我來說只有兩個非常快的。首先，特別是在您的 PCI 業務方面，我只是很好奇逆風對人員壓力有多大意義 - 人員短缺對 PCI 程序量有何影響？影響是否加劇？有改善嗎？您重申的關於人員配置影響的展望中包含了哪些內容？

So Calvin, the staffing issues is across the board in medtech. It impacts our essential high-risk PCI patients more than emergency. The emergency patients are priority. That's where they go. And then what we've also done is try to minimize the need to go to the ICU for high-risk PCI versus CCU or step down. And so similar to other people. But the one benefit that was apparent and shown this quarter is emergency patients are the priority, they get treated, and that's what drove our double-digit growth, both in the surgical suite and the cath lab.

所以卡爾文，醫療科技領域的人員配置問題是普遍存在的。它對我們重要的高風險 PCI 患者的影響比急診更大。急診患者優先。那就是他們去的地方。然後我們所做的就是盡量減少去 ICU 進行高風險 PCI 的需要，而不是 CCU 或退出。和其他人如此相似。但本季顯示的一個明顯的好處是急診患者是優先考慮的，他們得到治療，這就是推動我們在手術室和導管實驗室實現兩位數增長的原因。

Okay. And then the second one is on IPPS. So IPPS final rule again, was a positive outcome for you guys, and I think rates continue to be stable to slightly up following a pretty good proposed rule as well. I think specifically for DRG 3, I think it's associated with ECPELLA was up 10%, which is a high growth number compared to, I think historical periods and also other DRGs. So just curious, any read-through there? Is this a sustainable trend that we can perhaps see going forward?

好的。第二個是 IPPS。因此，IPPS 最終規則對你們來說再次是一個積極的結果，我認為利率也繼續保持穩定，並在遵循相當好的提議規則後略有上升。我認為特別是對於 DRG 3，我認為它與 ECPELLA 相關，增長了 10%，與歷史時期和其他 DRG 相比，這是一個很高的增長數字。所以只是好奇，有通讀嗎？這是我們未來可以看到的永續趨勢嗎？

Yes. I think we're in a great place right now for the appropriate reimbursement because the system set up by CMS and the physician experts has allowed its system of treatment for the sickest patients to be treated with DRG 1, so that's biventricular Impella or a patient that needs oxygenation and hemodynamic support, that's DRG 3, that's ECPELLA, that's around 10% to 14% of our patients every quarter, and that's growing. And we have new software now that integrates and lets the Impella know that ECMO is on board so they can wean. We have patients that are just getting high-risk PCI for -- and to support is 3 to 4 hours, that's DRG 216.

是的。我認為我們現在在適當的報銷方面處於一個很好的位置，因為 CMS 和醫生專家建立的系統已經允許其針對病情最嚴重的患者的治療系統接受 DRG 1 治療，所以這是雙心室 Impella 或患者需要氧合和血流動力學支持的患者，即DRG 3，即ECPELLA，每個季度約有10% 至14% 的患者接受該治療，而且這一數字還在不斷增長。我們現在擁有新的軟體，可以整合並讓 Impella 知道 ECMO 已安裝，以便它們可以離線。我們的患者剛接受高風險 PCI，支持時間為 3 到 4 小時，即 DRG 216。

And then, of course, we have those that are in cardiogenic shock that are going to require 3 to 4 days in the ICU, and that's DRG 215. And last is even the hub and spoke. So our ability now as the largest distribution team and the most -- the group with the most experts out there that can be bedside or it can get -- the hospitals can get phone support. And again, we're tracking nearly all our patients in the cloud in the U.S. So we have this incredible network that we're able to also support patients that want smaller hospital and then assist in transferring that patient to a large center with the Impella already in. And that's now the hospitals that receive that patient with Impella can bill for DRG 268.

當然，我們還有那些患有心因性休克的患者，需要在 ICU 待 3 到 4 天，這就是 DRG 215。因此，我們現在作為最大的分銷團隊和最多的團隊（擁有最多可以在床邊或可以獲得的專家的團隊），醫院可以獲得電話支援。再說一次，我們在美國的雲端中追蹤幾乎所有患者。現在，接收Impella 患者的醫院可以收取DRG 268 的費用。

And that gives them reimbursement to monitor and manage the patient in ICU and explant the device. So we really appreciate that the physician societies and the experts as well as CMS has really been very thoughtful about allowing heart recovery to occur. But again, Impella is one of the most cost-effective technologies that Medicare pays for and all of our FDA studies incorporate those 65-year-old patients and above. So it's taken us many years to get here, but we're appreciative because heart recovery can thrive now in the community.

這使他們能夠獲得監測和管理 ICU 患者以及移植設備的費用。因此，我們非常感謝醫師協會、專家以及 CMS 在讓心臟復健方面考慮得非常周到。但同樣，Impella 是 Medicare 支付的最具成本效益的技術之一，我們所有的 FDA 研究都納入了 65 歲及以上的患者。我們花了很多年才到達這裡，但我們很感激，因為心臟復健現在可以在社區中蓬勃發展。

This concludes the questions and answer session. I will turn the call to Michael Minogue.

問答環節到此結束。我會把電話轉給麥可·米洛。

Well, thank you, everyone, for your time today. And if you have follow-up questions, please reach out. Have a great day.

好的，謝謝大家今天抽出時間。如果您有後續問題，請與我們聯絡。祝你有美好的一天。

This concludes today's conference call. You may now disconnect your lines.

今天的電話會議到此結束。現在您可以斷開線路。