ABIOMED Inc (ABMD) 2022 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Second Quarter 2022 Abiomed 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, Nicole Nath, Manager of Investor Relations. Please go ahead.

美好的一天，感謝您的支持。歡迎參加 2022 年第二季 Abiomed 收益電話會議。 （操作員指示）請注意，今天的會議正在錄製中。 （操作員指示）我現在想將會議交給今天的發言人，投資者關係經理 Nicole Nath。請繼續。

Good morning, and welcome to Abiomed's Second Quarter Fiscal 2022 Earnings Conference Call. This is Nicole Nath, Manager, 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 2022 財年第二季財報電話會議。我是 Nicole Nath，投資人關係經理。我和 Abiomed 董事長、總裁兼執行長 Mike Minogue 一起來到這裡。副總裁兼財務長 Todd Trapp。

The format for today's call will be as follows: First, Mike will discuss second 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，麥克將討論第二季度的業務和營運亮點，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. Good morning, everyone. During the second quarter, we made progress on advancing our innovation, expanding clinical evidence and leveraging our premier commercial field team in a challenging environment with COVID and hospital staffing shortages. In Q2, Abiomed delivered $248 million of revenue, up 18% year-over-year, driven by 16% growth in the U.S. and record revenues in Europe and Japan, up 24% and 19%, respectively. The growth was driven by higher patient utilization and continued strength in our U.S. surgical business. We believe Delta and hospital labor shortages had regional impacts beginning in August and continuing into September. As a result, only 75% of our U.S. regions grew year-over-year. For the 25% of the regions negatively impacted, we believe, based on prior experience, we will see recovery in those regions in the future.

謝謝，妮可。大家，早安。第二季度，我們在推動創新、擴大臨床證據以及在新冠肺炎和醫院人員短缺等充滿挑戰的環境中利用我們一流的商業現場團隊方面取得了進展。第二季度，Abiomed 營收 2.48 億美元，年增 18%，其中美國市場成長 16%，歐洲和日本營收創紀錄，分別成長 24% 和 19%。這一增長得益於患者利用率的提高以及我們美國外科業務的持續強勁。我們認為，達美航空和醫院勞動力短缺從 8 月開始對區域產生影響，並持續到 9 月。因此，我們的美國地區只有 75% 實現了同比增長。對於25%受到負面影響的地區，我們相信，根據以往的經驗，我們將看到這些地區在未來恢復。

In Q2, the shortage of hospital staff, especially nursing, was a new dynamic that we had not experienced during the COVID pandemic. As a result, the Q2 revenue missed our internal July expectations. Overall, hospitals today are managing the treatment of the pandemic better, but Impella usage in the cath lab is still impacted by ICU capacity limitations. Hospital staffing shortages in the U.S. caused some health systems to reduce cardiac procedures or temporarily close facilities. Despite these headwinds faced within the quarter, the majority of U.S. regions remained resilient and recorded growth.

第二季度，醫院工作人員尤其是護理人員的短缺是我們在新冠疫情期間從未經歷過的新動態。因此，第二季營收未達到我們 7 月內部預期。總體而言，如今的醫院更好地管理了大流行的治療，但導管實驗室中 Impella 的使用仍然受到 ICU 容量限制的影響。美國醫院人員短缺導致一些衛生系統減少心臟手術或暫時關閉設施。儘管本季面臨這些不利因素，但美國大多數地區仍然保持彈性並實現了成長。

In Q2, we adapted within the quarter, by leveraging our Abiomed 2.0 playbook, which included monitoring specific trends on new COVID cases and hospital ICU capacity. This gave us the ability to adapt quickly to support high-risk or emergent patients, assist in patient transfer from spoke to hub, or support the ICU and patient with an Abiomed representative bedside or on the phone with Impella Connect.

在第二季度，我們利用 Abiomed 2.0 手冊在本季度進行了調整，其中包括監測新冠病例和醫院 ICU 容量的具體趨勢。這使我們能夠快速適應，以支持高風險或緊急患者，協助患者從分支轉移到中心，或透過 Abiomed 代表床邊或透過 Impella Connect 透過電話為 ICU 和患者提供支援。

Operationally, we achieved a 24% operating margin while investing a record level of $41 million in research and development to continue to advance our pipeline of life-saving devices. Our balance sheet remains robust with $862 million in cash and 0 debt, and our patent portfolio continues to gain strength with 1,297 patents and over 1,100 patents pending. We believe Abiomed has 1 of the strongest IP portfolios in the medical device industry, and we will add to it as we continue to innovate.

在營運方面，我們實現了 24% 的營業利潤率，同時在研發方面投資了創紀錄的 4,100 萬美元，以繼續推進我們的救生設備產品線。我們的資產負債表保持強勁，擁有 8.62 億美元現金和零債務，我們的專利組合繼續增強，擁有 1,297 項專利和 1,100 多項正在申請的專利。我們相信 Abiomed 擁有醫療器材產業最強大的智慧財產權組合之一，我們將在不斷創新的過程中對其進行補充。

On today's call, I will highlight advances in innovation, progress on regulatory approvals, and how Abiomed's premier field team is providing heart hospital teams breakthrough technology, landmark clinical studies and 24/7 support during a challenging time. At Abiomed, leading in technology and innovation is 1 of our 4 principles. During the quarter, we celebrated the 2-year anniversary of the FDA PMA approval for the Impella 5.5 with SmartAssist. This is our minimally invasive forward flow, fully unloading heart pump designed for heart surgeons with direct or axillary implantation in less than 60 minutes. This game-changing technology has enabled minimally invasive implantation with ambulation for more than 3,000 patients in the U.S. and has achieved greater than a 70% survival in a very sick, cardiogenic shock patient population.

在今天的電話會議上，我將重點介紹創新方面的進展、監管審批方面的進展，以及Abiomed 的一流現場團隊如何在充滿挑戰的時期為心臟病醫院團隊提供突破性技術、具有里程碑意義的臨床研究和24/7 支援。在 Abiomed，技術和創新領先是我們的 4 項原則之一。本季度，我們慶祝了帶有 SmartAssist 的 Impella 5.5 獲得 FDA PMA 批准兩週年。這是我們的微創前流、完全卸載心臟泵，專為心臟外科醫生設計，可在 60 分鐘內直接或腋窩植入。這項改變遊戲規則的技術已為美國 3,000 多名患者實現了可移動的微創植入，並在病情嚴重的心因性休克患者群體中實現了 70% 以上的存活率。

As a result, in Q2, U.S. Surgical revenue grew 60% year-over-year. Today, Impella 5.5 is in 27% of U.S. heart hospitals or 306 of the 1,113 hospitals. Furthermore, we are eager to bring this technology to Japan, and have already applied for PMDA approval. We believe the Japanese market is ideal for Impella 5.5 given its ability to provide minimally invasive, longer-term, unloading support, enabling native heart recovery in a country culturally averse to heart transplants and invasive sternotomies. We expect to receive Japanese PMDA approval for Impella 5.5 by this April 2022.

因此，第二季度美國外科收入年增 60%。如今，Impella 5.5 已應用於 27% 的美國心臟病醫院，即 1,113 家醫院中的 306 家。此外，我們渴望將這項技術帶到日本，並且已經申請了 PMDA 批准。我們認為日本市場是 Impella 5.5 的理想市場，因為它能夠提供微創、長期卸載支持，從而在一個文化上反對心臟移植和侵入性胸骨切開術的國家實現本地心臟復健。我們預計 Impella 5.5 將於 2022 年 4 月獲得日本 PMDA 的批准。

In Q2, we also expanded our Abiomed Breethe OXY-1 System to a total of 7 U.S. sites and have treated 53 patients, which concludes Phase II of our pilot site product launch. The clinical feedback, primarily from heart surgeons on this compact cardiopulmonary bypass system, has been positive based on the ease of use with a simple, intuitive interface and the light portable design allowing for patient ambulation. We will continue introducing this device at a measured pace and bring our disciplined approach to clinical data and innovation to the ECMO space.

在第二季度，我們也將 Abiomed Breethe OXY-1 系統擴展到美國總共 7 個地點，並治療了 53 名患者，至此我們試點產品推出的第二階段結束了。主要來自心臟外科醫生對這種緊湊型心肺旁路系統的臨床反饋是積極的，因為其簡單、直觀的界面以及允許患者走動的輕便便攜式設計易於使用。我們將繼續以穩健的步伐推出該設備，並將我們嚴格的臨床數據方法和創新引入 ECMO 領域。

On the regulatory front, we achieved multiple milestones. First, we launched Impella RP with SmartAssist at 4 sites and treated patients within the quarter. This smart pump is the next generation of our FDA-approved right heart device with a sensor and exclusive weaning capability. We also continue to make progress on the Impella RP with insertion through the internal jugular vein or IJ in the neck, as compared to the femoral vein in the leg. This is the preferred placement for heart surgeon -- heart surgeons and allows for early patient ambulation. We expect to file an Impella RP PMA supplement at the end of the fiscal year.

在監管方面，我們實現了多個里程碑。首先，我們在 4 個地點推出了帶有 SmartAssist 的 Impella RP，並在本季度內治療了患者。這款智慧型幫浦是我們經 FDA 批准的下一代右心設備，配有感測器和獨特的離線功能。與腿部股靜脈相比，我們在透過頸部頸內靜脈或 IJ 插入的 Impella RP 方面也持續取得進展。這是心臟外科醫生的首選放置位置，並允許患者儘早下床活動。我們預計在本財政年度結束時提交 Impella RP PMA 補充文件。

Second, in August, the FDA granted breakthrough device designation to Impella ECP. This designation means the FDA will prioritize Impella's ECP regulatory review processes including design iterations, clinical study protocols and PMA application. To date, we have enrolled 26 patients in the pilot EFS study at 4 hospitals. Based on the interaction with the FDA, we believe the high-risk PCI pivotal study will require a single arm with up to 225 Impella ECP patients at approximately 30 sites. We expect to lock in these details this quarter and enroll our first pivotal ECP patient in March and April, around the same time as our first Impella BTR patient in our FDA early feasibility study.

其次，8 月，FDA 授予 Impella ECP 突破性器械稱號。這項指定意味著 FDA 將優先考慮 Impella 的 ECP 監管審查流程，包括設計迭代、臨床研究方案和 PMA 申請。迄今為止，我們已在 4 家醫院招募了 26 名患者參加 EFS 試驗研究。根據與 FDA 的互動，我們認為這項高風險 PCI 關鍵研究將需要在大約 30 個地點對多達 225 名 Impella ECP 患者進行單組研究。我們預計本季鎖定這些細節，並在 3 月和 4 月招募我們的第一位關鍵 ECP 患者，大約與我們 FDA 早期可行性研究中的第一位 Impella BTR 患者同時入組。

Moving to my last highlight, Abiomed's premier commercial team has positioned us as the leading heart recovery company, validated with our breakthrough technology landmark clinical studies, and 24/7 clinical support. We are also actively engaging the referring community with our direct-to-patient initiative and hub-and-spoke model to bring awareness and treatment options to this underserved cardiac disease, high-risk patient population. Our Impella Connect remote monitoring and 24/7 support has been valuable to the healthcare providers during the COVID-19 resurgence and nurse labor shortages, because we assist with patient management as ICUs become strained.

最後一個亮點是，Abiomed 的一流商業團隊將我們定位為領先的心臟復健公司，並透過我們突破性技術、里程碑式的臨床研究和 24/7 臨床支援進行了驗證。我們也透過我們的直接面向患者的計劃和中心輻射模式積極吸引轉診社區的參與，為這一服務不足的心臟病高風險患者群體帶來認識和治療選擇。在 COVID-19 捲土重來和護理人員勞動力短缺期間，我們的 Impella Connect 遠端監控和 24/7 支援對醫療保健提供者非常有價值，因為我們在 ICU 緊張時協助病患管理。

Impella Connect software is now live at more than 85% of our U.S. sites, allowing for the majority of our U.S. patients on support to be monitored in the cloud by the field, the call center or the customer. Outside of the U.S., our Impella Connect software is now live at 37% of our Japanese sites and 14% of our European sites. Today, no other company in this space offers this level of support and expertise.

Impella Connect 軟體現已在我們 85% 以上的美國站點上線，允許現場、呼叫中心或客戶在雲端中對大多數接受支援的美國患者進行監控。在美國以外，我們的 Impella Connect 軟體現已在 37% 的日本站點和 14% 的歐洲站點上運行。如今，該領域沒有其他公司能夠提供如此程度的支援和專業知識。

Before I share a patient story, I want to remind listeners that 15 million Americans live with cardiac disease and it is the #1 cause of death in the U.S. with 875,000 deaths per year. Additionally, cardiovascular disease remains the leading cause of death in women.

在分享病人故事之前，我想提醒聽眾，有 1500 萬美國人患有心臟病，這是美國第一大死因，每年有 875,000 人死亡。此外，心血管疾病仍是女性死亡的主要原因。

Now our Impella patient Frannie Argulis, 61, is a mother, grandmother and nursing supervisor from Henrico, Virginia. Earlier in the year, Frannie experienced jaw pain then collapsed at home. Frannie's husband called 911 and the paramedics transported her to where she works at St. Mary's Hospital in Richmond, Virginia. The cardiologists remove blood clots in the cath lab and placed a stent in Frannie's right coronary artery. During the procedure, she went into cardiogenic shock and the cardiologists, Dr. Darren Appleton and Dr. Peter Rowe inserted the Impella CP with SmartAssist to support her left ventricle. While on support, SmartAssist technology triggered suction alarms, alerting physicians to check for right heart failure. Further testing confirmed right ventricular failure and the physicians inserted Impella RP to provide biventricular support.

現在，我們的 Impella 患者 Frannie Argulis，61 歲，是一位來自維吉尼亞州亨利科的母親、祖母和護理主管。今年早些時候，弗蘭妮感到下巴疼痛，然後倒在家裡。弗蘭妮的丈夫撥打了 911，醫護人員將她送往她在弗吉尼亞州里士滿聖瑪麗醫院工作的地方。心臟科醫生在導管室清除血塊，並在弗蘭妮的右冠狀動脈中放置了支架。在手術過程中，她出現了心因性休克，心臟病專家 Darren Appleton 博士和 Peter Rowe 博士插入了帶有 SmartAssist 的 Impella CP 以支撐她的左心室。在獲得支援時，SmartAssist 技術會觸發抽吸警報，提醒醫生檢查是否有右心衰竭。進一步測試證實右心室衰竭，醫生插入 Impella RP 以提供雙心室支持。

After 1 day, Frannie's left ventricle function improved and Impella CP was removed. 7 days later, Impella RP was weaned and removed and 3 days later, Frannie returned home. Today, Frannie has normal heart function with an EF of 55% and is back to work as a nursing supervisor and living an active lifestyle with her grandchildren. As a heart recovery patient, her insurer, Medical Mutual, will avoid paying for the most expensive and invasive lifetime procedures that come with LVADs and heart transplant.

1天后，Frannie的左心室功能改善，Impella CP移除。 7 天后，Impella RP 斷奶並被移走，3 天后，Frannie 回家了。如今，Frannie 的心臟功能正常，EF 為 55%，並重返護理主管工作崗位，與孫子們一起過著積極的生活方式。身為心臟復健患者，她的保險公司 Medical Mutual 將避免支付伴隨 LVAD 和心臟移植而來的最昂貴、最具侵入性的終身手術費用。

In conclusion, in Q2, we made progress on product innovation and regulatory milestones, while leveraging our commercial field team and the Abiomed 2.0 playbook in a challenging environment. Abiomed remains focused on disciplined execution and sustainable growth as we continue to pursue our goal of becoming the global standard of care to recover hearts and save lives.

總而言之，在第二季度，我們在產品創新和監管里程碑方面取得了進展，同時在充滿挑戰的環境中利用了我們的商業領域團隊和 Abiomed 2.0 手冊。 Abiomed 仍然專注於嚴格的執行和永續成長，因為我們繼續追求成為心臟康復和拯救生命的全球護理標準的目標。

To our employees and customers, you are the best in the industry. Thank you for your dedication and commitment to putting patients first. And to our shareholders, thank you for your continued support.

對我們的員工和客戶來說，你們是業界最優秀的。感謝您將患者放在第一位的奉獻和承諾。感謝我們的股東一直以來的支持。

I will now turn the call over to Todd.

我現在將把電話轉給托德。

Thanks, Mike, and good morning, everyone. In the quarter, we delivered revenue of $248 million, an increase of 18% versus prior year. Despite the challenges of the Delta variant and hospital labor shortages, we delivered double-digit growth across all geographies with record revenues in Europe and Japan. By region, the U.S. reported revenue of $200 million, up 16% versus prior year, driven by higher patient utilization and continued strength in our Surgical business. U.S. patient utilization increased 8% year-over-year, with growth in high-risk PCI and double-digit growth in cardiogenic shock. As Mike mentioned, we believe Delta and labor shortages had a more significant impact on patient utilization within the quarter, which caused us to miss our internal goal.

謝謝麥克，大家早安。本季度，我們營收 2.48 億美元，比去年同期成長 18%。儘管面臨達美航空變型和醫院勞動力短缺的挑戰，我們在所有地區都實現了兩位數的成長，其中歐洲和日本的收入創歷史新高。按地區劃分，美國報告的收入為 2 億美元，較上年增長 16%，這得益於患者利用率的提高和外科業務持續強勁的推動。美國患者的使用率年增 8%，其中高風險 PCI 的成長和心因性休克的兩位數成長。正如麥克所提到的，我們認為達美航空和勞動力短缺對本季的病患利用率產生了更重大的影響，這導致我們未能實現內部目標。

We will continue to leverage our Abiomed 2.0 playbook to adapt in this environment and assist the hospital's ICUs. Our product penetration continues to drive adoption and revenue growth. As a reminder to investors, all of the following details on product installed base is summarized in our quarterly slide deck. In the U.S., at the end of September, the Impella 2.5 and CP have reached 1,549 sites. The Impella 5.0 has been placed in 666 sites, and the Impella 5.5 with SmartAssist is now in 306 sites, up 49 sites versus prior quarter. The full market release of the Impella 5.5 with SmartAssist continues to perform well, with U.S. revenue growing 116% year-over-year.

我們將繼續利用 Abiomed 2.0 手冊來適應這種環境並為醫院的 ICU 提供協助。我們的產品滲透繼續推動採用和收入成長。提醒投資者，以下有關產品安裝基礎的所有詳細資訊都匯總在我們的季度幻燈片中。在美國，截至9月底，Impella 2.5和CP已達到1,549個站點。 Impella 5.0 已部署在 666 個站點，具有 SmartAssist 的 Impella 5.5 目前已部署在 306 個站點，比上一季增加了 49 個站點。配備 SmartAssist 的 Impella 5.5 全面上市後持續表現良好，美國營收年增 116%。

Finally, the Impella RP is in 634 sites. In the quarter, the reorder rate was 102%, slightly above prior year. Average combined inventory at the hospitals for the Impella 2.5 and CP was approximately 4.8 units per site, slightly above the inventory levels we saw last quarter. We continue to see a favorable impact on revenue from sales mix in the U.S., resulting in about 4 points of growth.

最後，Impella RP 已遍佈 634 個站點。本季度，再訂購率為 102%，略高於去年同期。醫院每個地點的 Impella 2.5 和 CP 平均合併庫存約為 4.8 台，略高於我們上季度看到的庫存水準。我們繼續看到美國銷售組合對收入產生有利影響，導致約 4 個百分點的成長。

Outside the U.S., we delivered record revenue of $48 million, up 27% year-over-year. Our European revenue increased 28% to $33 million versus prior year, driven by higher patient utilization, sales mix and timing of orders. However, Germany was slightly impacted by extended physician vacations, combined with nursing shortages in select areas. Despite these headwinds, our European business delivered record revenue in our second quarter. In Japan, we also delivered a record revenue quarter of $12 million, up 19% year-over-year. Impella utilization remained strong, up 33% versus prior year despite headwinds from a COVID resurgence in the Summer Olympics.

在美國以外，我們實現了創紀錄的 4,800 萬美元收入，年增 27%。由於患者利用率、銷售組合和訂單時間的提高，我們的歐洲收入比上年增長了 28%，達到 3,300 萬美元。然而，德國受到醫生假期延長以及某些地區護理人員短缺的輕微影響。儘管存在這些不利因素，我們的歐洲業務在第二季度仍實現了創紀錄的收入。在日本，我們也創下了季度營收 1,200 萬美元的紀錄，年增 19%。儘管夏季奧運會上新冠疫情捲土重來，Impella 的利用率仍然強勁，比去年增長了 33%。

Within the quarter, we opened 9 new sites, bringing our total sites to 180 out of a potential 350 hospitals.

在本季度內，我們開設了 9 個新站點，使我們的站點總數達到 180 個（潛在的 350 家醫院中）。

Moving to key financial metrics. Gross margin was 82.3% in the quarter compared to 81.5% in the prior year. The year-over-year variance was driven by sales mix and higher production volumes. In the second quarter, R&D expense totaled $41 million, an increase of 34% versus prior year. Year-over-year growth was driven by investments in small board devices like Impella ECP and XR Sheath. Future heart failure technologies such as preCARDIA and Impella BTR and STEMI DTU and PROTECT IV randomized controlled trials.

轉向關鍵財務指標。本季毛利率為 82.3%，而去年同期毛利率為 81.5%。同比差異是由銷售組合和產量增加所造成的。第二季研發費用總計4,100萬美元，較去年同期成長34%。同比成長是由對 Impella ECP 和 XR Sheath 等小型板設備的投資所推動的。未來的心臟衰竭技術，例如 preCARDIA 和 Impella BTR 以及 STEMI DTU 和 PROTECT IV 隨機對照試驗。

SG&A expense for the second quarter totaled $103 million, up 30% versus prior year, driven by investments in our direct-to-patient initiative, customer training and additions to our premier distribution team. In the quarter, non-GAAP operating income was $60 million, down 1% versus prior year, translating to an operating margin of 24.4%. This reflects growth investments tied to our continued focus on extending our lead with innovation, advancing clinical evidence and further enhancing our distribution team. Non-GAAP net income for the quarter was $47 million or $1.03 per diluted share versus $46 million or $1.01 in Q2 of '21. The year-over-year improvement was driven by higher interest income and a lower effective tax rate.

第二季度的 SG&A 費用總計 1.03 億美元，比去年同期增長 30%，這主要得益於我們對直接面向患者計劃、客戶培訓以及對一流分銷團隊的擴充的投資。本季度，非 GAAP 營業收入為 6,000 萬美元，較上年同期下降 1%，營業利潤率為 24.4%。這反映了我們持續專注於擴大創新領先地位、推進臨床證據和進一步增強我們的分銷團隊的成長投資。該季度非 GAAP 淨利潤為 4,700 萬美元，即稀釋後每股收益 1.03 美元，而 2021 年第二季的淨利潤為 4,600 萬美元，即稀釋後每股收益 1.01 美元。同比改善是由較高的利息收入和較低的有效稅率所推動的。

We had another solid quarter on cash, as we generated $61 million of operating cash flow. Our balance sheet is robust as we ended the quarter with $862 million of cash in marketable securities.

我們又一個現金充足的季度，產生了 6,100 萬美元的營運現金流。我們的資產負債表穩健，本季末我們有 8.62 億美元的有價證券現金。

Now turning to our outlook. With the impact of the pandemic and new challenges with hospital staffing shortages, uncertain conditions remain. In order to provide full transparency to our investors, we want to give insight on our revenue expectations for the second half of the year. The Delta variant and hospital labor shortages in the U.S. impacted August, September and continues to put pressure on Impella procedural volumes in October. Abiomed started the fiscal year with a range of $990 million to $1.03 billion with growth of 17% to 22% versus the prior year. After a record Q1 and a solid July, we upgraded our guidance to $1.03 billion to $1.05 billion, with growth of 22% to 24%.

現在轉向我們的展望。受疫情影響和醫院人員短缺的新挑戰，不確定性仍然存在。為了向投資者提供完全的透明度，我們希望深入了解下半年的收入預期。 Delta 變種和美國醫院勞動力短缺影響了 8 月和 9 月，並繼續對 10 月的 Impella 手術量造成壓力。 Abiomed 本財年開始時的銷售額為 9.9 億美元至 10.3 億美元，較上年增長 17% 至 22%。在經歷了創紀錄的第一季和強勁的 7 月之後，我們將預測上調至 10.3 億美元至 10.5 億美元，成長 22% 至 24%。

Given our current visibility to October, which appears to be trending towards approximately high single-digit revenue growth year-over-year, we expect Q3 global revenue to be slightly up from Q2. This assumes some improvement in Delta rates and hospital staffing in November and December. We now expect fiscal year '22 revenue to be in the range of $1.01 billion to $1.03 billion, an increase of 19% to 22% versus prior year and slightly above our original fiscal year '22 guidance. We expect non-GAAP operating margin to be in the range of 24% to 25%.

鑑於我們目前對 10 月的預期，預計 10 月的營收年增約為個位數，我們預計第三季全球營收將略高於第二季。這是假設 11 月和 12 月達美航空的運價和醫院人員配備有所改善。我們現在預計 22 財年的營收將在 10.1 億至 10.3 億美元之間，比上一年增長 19% 至 22%，略高於我們最初的 22 財年指引。我們預計非 GAAP 營運利潤率將在 24% 至 25% 之間。

In summary, while we navigate through the uncertainties, we remain focused on investing in innovation and clinical research and operational execution to achieve our fiscal year '22 goals. We remain confident in the long-term outlook for Abiomed as we continue to improve outcomes, recover hearts and save lives.

總之，在我們應對不確定性的同時，我們仍然專注於投資創新、臨床研究和營運執行，以實現我們 22 財年的目標。我們對 Abiomed 的長期前景仍然充滿信心，因為我們將繼續改善結果、恢復心臟和拯救生命。

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 Anthony Petrone from Jefferies.

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

I have a couple of questions. The first will be just on shortages and guidance, and we're hearing this on a couple of calls this quarter. And just wondering for Impella sites specifically how pervasive nursing shortages are in the ICUs, again, at the Impella sites? And then when you sort of look at the 3Q shortfall and the $20 million downward revision of guidance, is there a way to maybe splice between the Delta headwinds in 3Q and into the next couple of quarters? What's allocated toward Delta and what's allocated toward nursing shortages? And we'll have a couple of follow-ups on the pipeline.

我有一些問題。第一個問題只是關於短缺和指導，我們在本季度的幾次電話會議中聽到了這一點。只是想知道 Impella 站點的 ICU 護理人員短缺情況有多普遍？然後，當你看看第三季的缺口和 2000 萬美元的指導下調時，是否有辦法將達美航空在第三季和未來幾季的逆風結合起來？哪些資金分配給達美航空，哪些資金用於解決護理人員短缺問題？我們將在管道上進行一些後續行動。

Anthony, thanks for the call. It's a good question. It's something that we track. As we said in the call here, 75% of our U.S. sites grew. So we have a playbook to adapt to Delta. What was new is a little bit of the shortages of staffing. So the procedures want to be done. The physicians are engaged, but they don't have the surgical techs or the cath lab techs or ICU capacity that limits use. So that impacted about 25%. If we look at our -- just the same metric for cardiogenic shock, 83% of our regions grew. So we're a little more resilient and that plays to our ability to be relevant and help the patients and also help the ICU and the nurses there with training, with support, with online CMEs and anything else that we can do bedside.

安東尼，謝謝你的來電。這是一個好問題。這是我們追蹤的東西。正如我們在電話會議中所說，我們 75% 的美國網站實現了成長。所以我們有一個適應達美航空的劇本。新鮮的是人員配備有點短缺。所以要辦手續。醫生們很投入，但他們沒有限制使用的外科技術或導管實驗室技術或 ICU 能力。所以這影響了大約 25%。如果我們用同樣的指標來衡量心因性休克，就會發現 83% 的地區出現了成長。因此，我們更有彈性，這發揮了我們的能力，幫助患者，並透過培訓、支援、線上 CME 以及我們在床邊可以做的任何其他事情來幫助 ICU 和那裡的護理師。

If I think about the next part of the year, I think we've got the Delta variant somewhat managed as the hospitals know how to do this better. They're just assuming they're going to continue to have beds allocated for Delta. And don't forget that we treat some of those most severe sick Delta patients with our emergency use authorization for the RP or ECMO, V-V ECMO, which is the majority of our Breethe patients or ECpella. So we're still there providing support.

如果我考慮今年下半年，我認為我們已經對 Delta 變種進行了某種程度的管理，因為醫院知道如何做得更好。他們只是假設他們將繼續為達美航空分配床位。不要忘記，我們透過 RP 或 ECMO、V-V ECMO 的緊急使用授權來治療一些病情最嚴重的 Delta 患者，其中大多數是 Breethe 患者或 ECpella。所以我們仍然在那裡提供支持。

On the shortages, I think what's going to happen is it's going to be incremental. They're going to continue to prioritize the sickest of the sick patients, which is some of -- or most of our patients. And I think the hospitals are resilient, but they're going to need help. And that's where the Abiomed field team, Impella Connect, IQ database, and the training as well as the networking between the hub and spoke and transfer will be helpful.

關於短缺，我認為將會發生的事情是增量的。他們將繼續優先考慮病情最嚴重的患者，這是我們的一些或大多數患者。我認為醫院很有彈性，但他們需要幫助。這就是 Abiomed 現場團隊、Impella Connect、IQ 資料庫、培訓以及中心、輻條和傳輸之間的網路將發揮作用的地方。

A quick follow-up there, Mike, would be if you have -- using your crystal ball and what you guys see, I mean how deep into 2022 do you think the nursing shortage issue will last? And what do you think the fix will be? And just quickly on the pipeline, any expectations just for timing on the launch of XR Sheath on CP specifically into calendar '22 and what should we be watching for into next year for the transition of ECP from early feasibility to the pivotal study?

麥克，一個快速的後續行動是，如果你有——使用你的水晶球和你們所看到的，我的意思是，你認為護理短缺問題會持續到 2022 年多久？您認為解決方法是什麼？很快就在醞釀中，對於在 CP 上推出 XR 護套的時間有什麼期望，特別是在 22 日曆年，我們應該關註明年 ECP 從早期可行性到關鍵研究的過渡嗎？

Sure, Anthony. So remember, the -- it's the Delta variant with ICU capacity and the nursing shortages. So that's currently impacting less than 20% of our hospitals and we do think that comes back, and we have seen that come back. So I think as time goes on, that will get minimized. I also think it's an opportunity for Abiomed, because of our field team, our clinical expertise, our bedside support, call center and Impella Connect, that we can help augment what they're doing and assist them in that shortage. And I think it's going to get better. And I think hospitals are more resilient now. So we see this as something that will allow us to continue to grow, and we're well positioned as they continue to train new nurses and we'll probably part of that process.

當然，安東尼。所以請記住，這是具有 ICU 容量和護理人員短缺的 Delta 變體。目前，這種情況影響到我們不到 20% 的醫院，我們確實認為這種情況會捲土重來，而且我們已經看到這種情況捲土重來。所以我認為隨著時間的推移，這種情況將會最小化。我還認為這對 Abiomed 來說是一個機會，因為我們的現場團隊、臨床專業知識、床邊支援、呼叫中心和 Impella Connect，我們可以幫助增強他們正在做的事情並幫助他們解決短缺問題。我認為情況會變得更好。我認為醫院現在更有彈性。因此，我們認為這將使我們能夠繼續成長，並且我們處於有利地位，因為他們繼續培訓新護士，我們可能會參與這一過程。

On the XR Sheath, nothing has changed relative to our prior. As you heard on the call, we have a list of new products and new approvals. So we're trying to prioritize for the call here, what are the biggest ones or the most important ones and ones that are happening in the next 6 months. So ECP is a great progress. I think it's ahead of schedule from everything we've been stating. We announced today that we expect to have the 5.5 approved in Japan by April, which is -- hadn't been commented on. And I think the 5.5 is going to be a breakthrough product in Japan, because of the culture there and the aversion to sternotomies and heart transplant.

在 XR 護套上，相對於我們之前的產品沒有任何變化。正如您在電話中聽到的那樣，我們有一份新產品和新批准的清單。因此，我們正在努力確定此次電話會議的優先順序，最大或最重要的事項以及未來 6 個月內發生的事項是什麼。所以ECP是一個很大的進步。我認為從我們所說的一切來看，這都提前了。我們今天宣布，預計 5.5 將於 4 月在日本獲得批准，但尚未對此發表評論。我認為 5.5 在日本將成為突破性產品，因為那裡的文化以及對胸骨切開術和心臟移植的厭惡。

The BTR pump is there's -- it's a minimally invasive dischargeable LVAD. There's nothing like it in the world. It's what physicians and surgeons have wanted for 10 years. And we expect to be doing patients first in man here in the U.S. through the early feasibility in March and April. We haven't commented about the PreCARDIA, but that continues with the EFS, and we're looking forward to going to Phase III on the ECMO.

BTR 幫浦就在那裡——它是一種微創可放電 LVAD。世界上沒有這樣的事。這是內科醫生和外科醫生十年來一直想要的。我們預計透過三月和四月的早期可行性研究，首先在美國對人類患者進行治療。我們還沒有對 PreCARDIA 發表評論，但 EFS 仍在繼續，我們期待 ECMO 進入第三階段。

So with all of that technology, we have to continue to execute, control what we control. And it just points to the fact that we are the leaders now for the heart team. Essentially, every single heart team out there is working with Abiomed on a product, in the cath lab, the surgical suite or the ICU or in the cloud. And we have the landmark clinical studies to back up the data as well. So we're excited for that. And I think we're going to continue to see more momentum. And whatever happens in the future, we'll be well positioned and will support our hospitals.

因此，對於所有這些技術，我們必須繼續執行，控制我們所控制的內容。這只是表明我們現在是心臟團隊的領導者。本質上，每個心臟團隊都在導管實驗室、手術室、重症監護室或雲端與 Abiomed 合作開發產品。我們還有具有里程碑意義的臨床研究來支持​​數據。所以我們對此感到興奮。我認為我們將繼續看到更多的勢頭。無論未來發生什麼，我們都將處於有利位置並支持我們的醫院。

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。

I was hoping to go first into a little bit more detail on how October looks. It sounded like things maybe were improving, and then based on the Q3 comments, you're sort of expecting something similar for the full quarter, but not necessarily improving from what you guys are seeing in October. So is that the right read? Or there's some comps that we're maybe not anticipating? And then what does that imply for the implied fiscal fourth quarter outlook with kind of those similar dynamics that you referenced?

我希望首先更詳細地了解十月的情況。聽起來情況可能正在改善，然後根據第三季的評論，您預計整個季度會出現類似的情況，但不一定比十月的情況有所改善。那麼這樣的讀法正確嗎？或者有一些我們可能沒有預料到的比較？那麼，這對於隱含的第四季度財政前景以及您提到的類似動態意味著什麼？

So Margaret, this is Todd. Thanks for the question. I think it was -- your read is right. I mean we -- in my prepared remarks, we said that October was up mid-single digits from a growth perspective. Obviously, for us to be slightly up from Q2 into Q3, we're somewhere in that 7%, 8% top line growth. So we do expect to see it improve a little bit from October as we get into November and December, and that's what we're hearing from our field team. We think some of the headwinds from Delta sort of subside over the next 2 months, but that's the expectation as we get into Q3.

瑪格麗特，這是托德。謝謝你的提問。我認為——你的解讀是正確的。我的意思是，在我準備好的發言中，我們說從成長的角度來看，十月成長了中位數。顯然，對我們來說，從第二季到第三季略有上升，我們的營收成長處於 7%、8% 的水平。因此，我們確實預計，隨著進入 11 月和 12 月，情況將從 10 月開始有所改善，這就是我們從現場團隊那裡聽到的。我們認為達美航空的一些不利因素將在未來兩個月內消退，但這是我們進入第三季時的預期。

And as I look at Q4, when we look at the low end of the range, I think we assume that as the business continues to recover, and we see a modest or gradual lift from Q3 to Q4. Again, as Delta cases improve and hospitals are able to manage -- I'd say, manage better their labor shortages, which are reducing some of the limitations on the ICU capacity. So I think your read is right. And again, we're just trying to be as transparent and provide investors with what we're seeing so far in the month of October.

當我觀察第四季度時，當我們觀察該範圍的低端時，我認為我們假設隨著業務的持續復甦，我們會看到從第三季到第四季的適度或逐步提升。同樣，隨著達美航空病例的改善以及醫院能夠更好地管理勞動力短缺問題，這正在減少對 ICU 容量的一些限制。所以我認為你的閱讀是正確的。再說一次，我們只是試圖保持透明，並向投資者提供我們在 10 月迄今為止所看到的情況。

Okay. Now that's useful. And then just as a follow-up, I wanted to talk a little bit about 5.5 launching in Japan and then the Breethe launches as well, because that does seem to be moving nicely. So any, I guess, first on Breethe any additional details on the rollout so far, any surprises or something that potentially could accelerate that launch. And then in Japan for that 5.5, could it be as material there as it is in the U.S., both from a pricing and demand perspective?

好的。現在這很有用。作為後續行動，我想談談 5.5 在日本的發布，然後 Breethe 也發布了，因為這似乎進展順利。因此，我想，首先，關於迄今為止推出的任何其他細節、任何驚喜或可能加速發布的事情。那麼在日本，從定價和需求的角度來看，5.5 是否會像在美國一樣重要？

Thanks, Margaret. Those are the questions that our engineering and clinical team are both working on. So starting with Breethe, we have been tracking all the patients. The ECMO space is interesting, because it does not require any clinical data. It's a 510(k) clearance only. And so we are approaching that space as a PMA company. We're looking and collecting the data as a PMA company. We're looking for best practices. What we recently did in Europe is we did our first patient under an ECpella software, where we're combining the software so you can optimize and the systems talk to each other and you can wean that patient, and know what's happening as you unload the heart and also perfuse and oxygenate the body.

謝謝，瑪格麗特。這些是我們的工程和臨床團隊正在研究的問題。從 Breethe 開始，我們一直在追蹤所有患者。 ECMO 領域很有趣，因為它不需要任何臨床數據。這只是 510(k) 許可。因此，我們作為一家 PMA 公司正在涉足這一領域。我們作為 PMA 公司正在尋找和收集數據。我們正在尋找最佳實踐。我們最近在歐洲所做的是，我們在ECpella 軟體下治療了我們的第一個患者，我們將軟體組合在一起，這樣您就可以進行優化，系統可以相互通信，您可以讓該患者斷奶，並知道當您卸載該軟體時會發生什麼。心臟，也為身體灌注和供氧。

So there's some really amazing things that we're going to be able to do currently and also some things we're going to do in the future with AI. Also, what we're starting to work on, we've done our first patient where we have Impella Connect running from a helicopter and a lot of ambulances are starting to connect with WiFi. So we're putting Impella Connect on the ECMO device. So whether you're ECMO only Impella or ECpella, we'll be able to transmit that data into the cloud. And whether the person is being -- is at a hospital or being transferred on an ambulance or in a helicopter, that will be an exclusive feature.

因此，我們目前能夠做一些非常令人驚奇的事情，並且未來我們將利用人工智慧做一些事情。此外，我們正在開始做的事情是，我們已經完成了第一個病人的治療，我們從直升機上運行 Impella Connect，並且許多救護車開始與 WiFi 連接。因此，我們將 Impella Connect 安裝在 ECMO 設備上。因此，無論您是僅使用 ECMO 的 Impella 還是 ECpella，我們都能夠將資料傳輸到雲端。無論這個人是在醫院，還是被救護車或直升機轉移，這都將是一個獨家功能。

And we're excited to bring all this innovation and knowledge and clinical expertise to that space.

我們很高興能夠將所有這些創新、知識和臨床專業知識帶入該領域。

For the 5.5, it's just -- it is a breakthrough product. I mean you have the ability to have a full VAD. So I've been in this space 18 years. And what the heart surgeons always wanted was a minimally invasive weanable VAD. And with the Impella, you get that. And the fact that it's forward flow means that as the pump is working, it's resting the heart. But as you want to reload the heart, as you turn it down, it allows the heart to naturally start to pump with sensors on the device that we can see how the heart is recovering. And it's really revolutionary, because it's -- all the other VADs and ECMO devices are essentially dumb devices. You put them in and you really don't have any way of knowing how the heart is doing.

對於 5.5 來說，它只是一個突破性的產品。我的意思是你有能力擁有完整的 VAD。我在這個領域已經工作了 18 年。心臟外科醫生一直想要的是一種可撤機的微創 VAD。有了 Impella，您就明白了。事實上，它是向前流動的，這意味著當泵工作時，它會使心臟休息。但是，當您想要重新加載心臟時，當您將其調低時，它可以讓心臟自然地開始用設備上的感測器跳動，我們可以看到心臟如何恢復。它確實具有革命性，因為所有其他 VAD 和 ECMO 設備本質上都是啞設備。你把它們放進去，你真的無法知道心臟是如何運作的。

And what's most important for these patients is you get survival with native heart recovery, because survival is the low bar. And even if you survive, many of these papers don't even give heart recovery numbers and these patients end up in hospice care or maybe even those that are lucky, they can get a transplant. So the amount of information we're doing around recovery will be accelerated in Japan where they believe in stem cell. They've been -- they've had advanced publications in science of hemodynamic unloading and pressure volume loops. And we think it will be material, be a revolutionary treatment and it will be in a country that really focuses on heart recovery more than anything else, and we're super excited to bring that product to Japan.

對於這些患者來說，最重要的是透過自然心臟恢復來獲得生存，因為生存是最低標準。即使你活了下來，這些論文中的許多甚至沒有給出心臟復健的數字，這些患者最終會接受臨終關懷，甚至那些幸運的人可能會得到移植手術。因此，在相信幹細胞的日本，我們圍繞康復所做的資訊量將會加快。他們已經在血流動力學卸載和壓力容量環科學方面發表了先進的出版物。我們認為這將是物質性的，是一種革命性的治療方法，而且將在一個真正注重心臟復健的國家進行，我們非常高興將該產品帶到日本。

Our next question comes from Chris Pasquale from Guggenheim.

我們的下一個問題來自古根漢的克里斯·帕斯誇萊。

Mike, if I look back at the good old days, before we had all this macro volatility, your second quarter tends to be about flat sequentially, plus or minus a couple of million dollars. So I'm a little surprised to hear that this quarter's result was significantly below what you were thinking. Can you break down the $20 million guidance reduction between this quarter's shortfall as you saw it and how much you're taking out of the back half of the year?

麥克，如果我回顧過去的美好時光，在我們經歷所有這些宏觀波動之前，您的第二季度往往會持平，上下浮動數百萬美元。因此，當我聽到本季的結果明顯低於您的想法時，我感到有點驚訝。您能否詳細分析您所看到的本季缺口與今年下半年的缺口之間 2000 萬美元的指導減少額？

Sure, Chris. And you're right. That is something we look at. And if you're looking at the numbers on the guidance, our normal 47%-53% puts us at a higher range. If you look at our guidance, we're essentially back to where we started the fiscal year, but we've lowered -- or we've increased the lower end of the range. So we started the fiscal year with 17% to 22%. We upgraded it to 22% to 24% after Q1, which was incredibly strong. And we had great momentum. We -- the playbook was working. We hadn't yet seen a little bit of the August impact, starting with maybe some extended vacations, Delta ramp and then also shortages that are out there in staff.

當然，克里斯。你是對的。這是我們所關注的。如果您查看指南中的數字，我們正常的 47%-53% 使我們處於更高的範圍。如果你看看我們的指導，我們基本上回到了本財年開始時的水平，但我們已經降低了——或者我們已經提高了範圍的下限。因此，本財年伊始，我們的成長率為 17% 至 22%。第一季後我們將其提升至 22% 至 24%，這是非常強勁的。我們勢頭強勁。我們——劇本正在發揮作用。我們還沒有看到八月的一點影響，首先是一些延長的假期、達美航空的停機坪，然後是員工的短缺。

So I think what happened is in July, it hit in August. August was a little bit down and that carried into September. You're also right that we usually do see the summer quarter dip a little bit. Usually, that dip is in patients, where we go a little down or flat. But we tend to open more centers, do more training. And we do have a lot of new products that we're opening in -- that we've already mentioned. So that's where we expected to see a higher number than we achieved. It is the third highest quarter we've ever done in revenue and patients, but we thought we were going to do better.

所以我認為發生的事情是在七月，八月發生的。八月略有下降，這種情況一直持續到九月。你說得也對，我們通常會看到夏季季度的銷售量會略有下降。通常，這種下降發生在患者身上，我們會稍微下降或持平。但我們傾向開設更多中心，進行更多培訓。我們確實有很多新產品即將上市——我們已經提到過。因此，我們預計會看到比我們實際實現的數字更高的數字。這是我們有史以來收入和患者數量第三高的季度，但我們認為我們會做得更好。

And I think what we're trying to give you transparency to is that the model of the 47% to 53% is just probably not going to be a perfect model this year, because of not just COVID, but some of the shortages. But as we're working through the shortages and as I think the hospitals are responding, I think we're going to end up getting back to where we were in the good old days and have just an incredible strong second half of the fiscal year.

我認為我們試圖向大家提供的透明度是，47% 到 53% 的模型今年可能不會成為一個完美的模型，不僅因為新冠疫情，還因為一些短缺。但隨著我們正在解決短缺問題，而且我認為醫院正在做出反應，我認為我們最終將回到過去的美好時光，並在本財年下半年取得令人難以置信的強勁表現。

Okay. That's helpful. And then you mentioned that Impella is used to actually treat some of these COVID patients. It would be helpful to understand a little better how material a factor that is particularly in a quarter like this where we saw a surge in COVID cases. Can you quantify at all how much do you think that contributed in the second quarter?

好的。這很有幫助。然後你提到 Impella 被用來實際治療一些新冠肺炎患者。更了解這一因素的重要性將會有所幫助，尤其是在我們看到新冠病例激增的這個季度。您能量化一下您認為這對第二季的貢獻有多大嗎？

Chris, we track every patient and all the trends. Unfortunately, the patients that we treat are really sick. So that's bad for the patient and the hospital, but what that does is that starts to take the beds and an extended stay will take out a lot of our Protected PCI patient availability. And that's where the hub and spoke and moving patients around is helpful. So if something happens in the spoke hospital, we might help with getting that patient transferred to a bigger hub hospital. What we also saw, when we track small, medium and large hospitals, is the trend in September was the medium hospitals tended to be more impacted.

克里斯，我們追蹤每一位患者和所有趨勢。不幸的是，我們治療的病人確實病得很重。因此，這對患者和醫院都不利，但這樣做會導致床位開始被佔用，並且延長住院時間將導致我們的大量受保護 PCI 患者的可用性減少。這就是中心和輻條以及移動患者的有用之處。因此，如果分支醫院發生問題，我們可能會幫助將該患者轉移到更大的中心醫院。當我們追蹤小型、中型和大型醫院時，我們也看到，9月的趨勢是中型醫院往往受到更大的影響。

And while we saw the growth happen year-over-year and especially in shock, those medium-sized users of ours were impacted a little more. Maybe they weren't as resilient with their protocols or maybe they were more impacted by the nursing shortages or the facilities were minimized, but I think as we look at the total picture, the cardiogenic shock patients, whether they have COVID or not, that's what's happening. And when you think of myocarditis shock or COVID, you're talking about problems with the lungs, the heart and the kidneys, and that's what our products are designed to do, and that's what our products are FDA approved for.

雖然我們看到年成長，尤其是在衝擊中，但我們的中型用戶受到更大的影響。也許他們對自己的方案沒有那麼有彈性，或者可能他們受到護理短缺或設施最小化的影響更大，但我認為，當我們看到整體情況時，心源性休克患者，無論他們是否患有新冠病毒，這就是發生了什麼事。當您想到心肌炎休克或新冠肺炎時，您指的是肺部、心臟和腎臟的問題，這就是我們產品的設計目的，也是 FDA 批准我們產品的用途。

So we continue to look at this as just a broader heart failure population and specifically to COVID, you've seen the majority of these patients getting ECMO where they do V-V ECMO, where it's pure oxygenation, not necessarily heart support. But that's a great question.

因此，我們繼續將其視為更廣泛的心臟衰竭人群，特別是對於新冠肺炎，您已經看到大多數患者接受了 ECMO，他們進行 V-V ECMO，這是純氧合，不一定是心臟支持。但這是一個很好的問題。

Okay. So I guess what I'm hearing is maybe at the margin that's offsetting some of the lost volume that's being squeezed out by the capacity constraints, but net-net, it's still a headwind overall?

好的。所以我想我聽到的可能是抵消一些因容量限製而被擠出的銷售損失，但總的來說，這仍然是一個逆風？

Correct.

正確的。

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。

Sorry to keep going on the guidance side of things. But I wanted to tease out this $20 million reduction from Q1 to Q2. I think you had said last quarter, the bottom end of the range is what you expected, if COVID was uneven, so that's about $10 million of the $20 million. I'm sure COVID is probably a little bit worse than you expected here in the quarter and likely for the rest of the year. So it seems like the $20 million reduction, maybe, I don't know, $12 million of that is COVID related, maybe somewhere in the $5 million to $10 million range is staffing shortage related for the back half of the year. So is that a reasonable assessment of what's kind of going on here? And then with this kind of $5 million to $10 million for half of the year impact from a shortage perspective, are hospitals able to adjust here heading into fiscal '23 to offset what's a $10 million to $20 million headwind on the staffing shortage side? I'm sorry for the long question.

很抱歉繼續提供指導。但我想弄清楚從第一季到第二季減少了 2000 萬美元。我想你在上個季度說過，如果新冠疫情不均衡，那麼這個範圍的下限就是你所期望的，所以這大約是 2000 萬美元中的 1000 萬美元。我確信新冠疫情在本季以及今年剩餘時間內的情況可能比您預期的要嚴重一些。因此，似乎減少了 2000 萬美元，也許，我不知道，其中 1200 萬美元與新冠病毒相關，也許 500 萬至 1000 萬美元範圍內的某個地方與下半年的人員短缺有關。那麼，這是對這裡發生的情況的合理評估嗎？然後，從短缺的角度來看，由於半年的 500 萬至 1000 萬美元的影響，醫院是否能夠在進入 23 財年時進行調整，以抵消人員短缺方面的 1000 萬至 2000 萬美元的逆風？我很抱歉問了這麼長的問題。

Yes, Matt, let me -- there's a lot of questions. So let me just kind of walk you through again the rationale and I tried to lay it out during the script with regard to the earnings. But again, as you said here and we got through our first quarter, right? Our first quarter was a record quarter for Abiomed on both revenue as well as patients, right? And then we got into July, and we had, I would say, a really solid July, both from a normal seasonality perspective, and expectations on both revenue and patients. And so if you just look at our annualized, our Q1 performance, at that time, you get to over $1.01 billion. And then as Mike mentioned, right, we typically have normal seasonality, right? So it's typically 47% first half, 53% second half, and that came into our process.

是的，馬特，讓我——有很多問題。因此，讓我再次向您介紹其基本原理，我試圖在劇本中就收益進行闡述。但同樣，正如你在這裡所說的，我們度過了第一季度，對嗎？我們的第一季對於 Abiomed 來說無論是收入還是患者數量都是創紀錄的，對嗎？然後我們進入了七月，我想說，從正常的季節性角度以及對收入和患者的期望來看，我們度過了一個非常穩定的七月。因此，如果你只看我們第一季的年化業績，當時的營收將超過 10.1 億美元。正如麥克所提到的，我們通常有正常的季節性，對吧？所以通常上半場佔 47%，下半場佔 53%，這也進入了我們的流程。

So after the first 4 months, of the year, we felt actually really good about the revised range of $1.03 to $1.05 at that time. And then the Delta surge impacted us in the month of August. And it really hit some of our larger markets, i.e., Florida and Texas as well as some of the other regions in the Southeast. And then what was new for us in August was this dynamic of hospital labor shortages. And so we did not encounter that headwind in the previous pandemic -- in a previous pandemic. And so I think the labor shortages are temporary, but they have been putting more pressure on procedural volumes across the U.S. And I think these 2 headwinds, as I mentioned, really impacted August and September performance and caused us to miss our internal forecast by, I'd say, that $5 million to $7 million range.

因此，在今年的前 4 個月之後，我們對當時 1.03 美元至 1.05 美元的修訂區間感到非常滿意。然後達美航空的激增在八月影響了我們。它確實影響了我們的一些較大市場，即佛羅裡達州和德克薩斯州以及東南部的一些其他地區。八月對我們來說新的事情是醫院勞動力短缺的動態。因此，我們在先前的大流行中並沒有遇到這種逆風。因此，我認為勞動力短缺是暫時的，但它們給美國各地的程序量帶來了更大的壓力。正如我所提到的，我認為這兩個不利因素確實影響了8 月和9 月的表現，並導致我們錯過了內部預測，我想說，這個範圍是 500 萬到 700 萬美元。

With that said, we did still deliver 18% growth versus prior year. And as a reminder, we did have positive growth in Q2 quarter of last year. So I think it was -- we thought it was prudent to really update our guidance at this point of time to $1.01 billion to $1.03 billion, which again was slightly above our initial guidance. And again, all we're trying to do is be as transparent with you as we can during these uneven times.

儘管如此，與去年相比，我們仍然實現了 18% 的成長。提醒一下，我們去年第二季確實實現了正成長。所以我認為，我們認為此時將我們的指導方針真正更新為 10.1 億美元至 10.3 億美元是謹慎的做法，這再次略高於我們最初的指導方針。再說一次，我們所做的就是在這個不平坦的時期盡可能對您保持透明。

Okay. And then, Mike, on the pipeline side of things, with all these headwinds on the COVID side and staffing shortages, is there any potential impact to being able to enroll studies or get anything done as far as the pipeline goes? And then on ECP, is that something you're talking about 225 patients. Is that something you can enroll in 12 to 18 months? Or is it going to take a little bit longer than that?

好的。然後，邁克，在管道方面，由於新冠疫情方面的所有不利因素和人員短缺，就管道而言，對能夠註冊研究或完成任何事情是否有任何潛在影響？關於 ECP，您正在談論 225 名患者。您可以在 12 到 18 個月內註冊嗎？還是需要比這更長一點的時間？

So Matt, great questions, a lot of questions. Let me start with our customers and our trialists are totally passionate and committed to these studies. And while other companies are not doing studies or put them on pause, we have multiple RCTs and post-approval studies running. So we did do 18 patients on PROTECT IV. We now have -- I'm going to give you up-to-date numbers. We have 24 randomized patients in P4. We have 28 in the registry for that protocol, and we have 18 sites that are fully enrolling up and running. So that's pretty impressive in the quarter with everything we just went through on Delta and shortages.

馬特，很好的問題，很多問題。讓我從我們的客戶開始，我們的試用者對這些研究充滿熱情並致力於其中。雖然其他公司沒有進行研究或暫停研究，但我們正在進行多項隨機對照試驗和批准後研究。所以我們確實對 18 位患者進行了 PROTECT IV 治療。我們現在——我將向你們提供最新的數字。我們有 24 位隨機進入 P4 的患者。我們在該協議的註冊表中有 28 個，並且有 18 個站點正在完全註冊並運行。因此，本季的表現非常令人印象深刻，因為我們剛剛經歷了達美航空和短缺的一切。

On STEMI, we are -- we did it over 10 patients in the quarter. We have 36 sites that are enrolling, and we're at 99 patients. We're going to have a 100-patient recognition here, and that continues to move. So we're excited about that.

對於 STEMI，我們在本季對 10 多名患者進行了治療。我們有 36 個站點正在招募，共有 99 名患者。我們將在這裡對 100 名患者進行表彰，而且這一情況還在繼續發展。所以我們對此感到興奮。

The last component of your question, I believe, was the ECP. And we are going to make it a priority. We're going to -- with the sites that are there. We're going to have them enroll and the fact that we'll have a 9 French device, means the peripheral vascular disease and many of these other things that might cause certain challenges, it will cast a wide net and we're going to ask the centers that are in that study to prioritize and to go efficiently, but there is tremendous demand and excitement for that product as well.

我認為你問題的最後一個組成部分是 ECP。我們將把它作為優先事項。我們將利用那裡的網站。我們會讓他們註冊，事實上我們將擁有一個 9 French 設備，這意味著周圍血管疾病和許多其他可能會帶來一定挑戰的事情，它將撒下一張廣泛的網，我們將要求參與研究的中心確定優先順序並有效率地進行，但對該產品也有巨大的需求和興奮。

So the 1 thing, regardless of what's happening, our job is to continue to adapt and execute. We have taken advantage of the internal things we can control whether it's innovation or the clinical research, and we feel that nothing stops innovation. So as we continue to innovate and improve outcomes for patients, we're incredibly confident in the time lines that are out there for new products in these clinical studies.

因此，第一件事，無論發生什麼，我們的工作就是繼續適應和執行。我們利用了我們可以控制的內部事物，無論是創新還是臨床研究，我們覺得沒有什麼可以阻止創新。因此，隨著我們不斷創新和改善患者的治療效果，我們對這些臨床研究中新產品的時間表充滿信心。

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。

Mike and Todd, with these hospital labor shortages, just giving it some thought. I mean I feel like now is the time more than ever that you guys are able to leverage Impella Connect and the capabilities there. And I'm just wondering if you're seeing any incremental traction or adoption. I know it's a net negative, COVID is a net negative, but incremental adoption because of your Impella Connect capabilities, and the hospital labor shortages, which do feel like that's not easy fix and Impella Connect offers a very good solution. Anything you can say qualitatively around that would be great.

麥克和托德，鑑於醫院勞動力短缺，只是想一下。我的意思是，我覺得現在比以往任何時候都更適合你們利用 Impella Connect 及其功能。我只是想知道您是否看到了任何增量的吸引力或採用。我知道這是一個淨負面影響，新冠疫情是一個淨負面影響，但由於Impella Connect 功能和醫院勞動力短缺而逐漸採用，這確實讓人感覺這並不容易解決，而Impella Connect 提供了一個非常好的解決方案。任何你能對此進行定性評價的事情都會很棒。

Danielle, thanks for the question. I think your -- it's a very insightful question, because you're recognizing what we've been investing in is to provide a level of support that doesn't exist in the industry, whether it's bedside or in the cloud or capturing the data, or even training nurses. So as the nurses that are coming into the ICU, they're newer, we can work with them, we can do hands-on training, they can go online and do CME training, and we can coordinate specialized care. So we continue to do that.

丹妮爾，謝謝你的提問。我認為這是一個非常有洞察力的問題，因為您認識到我們一直在投資的目的是提供行業中不存在的一定程度的支持，無論是床邊、雲端還是捕獲數據，甚至培訓護士。因此，作為進入 ICU 的護士，他們是新人，我們可以與他們一起工作，我們可以進行實踐培訓，他們可以上網進行 CME 培訓，我們可以協調專業護理。所以我們繼續這樣做。

I just want to be clear, though, that the Delta variant had the massive impact and what made it more complicated for us and the playbook was the labor shortages that did not impact 75% of our sites. The impact was more of 25% of our sites. And for shock, it impacted less than that 17%. So I think that what we're doing is we're whittling away at it, and we're trying to minimize it with exactly what you're talking about with our bedside support, with our SmartAssist. It makes managing the patient easier with Impella Connect, putting that in the cloud, so that our experts, our nurses, our call center and our local people as well as the physicians can review that patient without being bedside and then quantitatively put numbers on it and track it.

不過，我只是想澄清的是，Delta 變體產生了巨大的影響，而對我們來說，讓情況變得更加複雜的原因是勞動力短缺，但並未影響到我們 75% 的站點。我們超過 25% 的網站受到了影響。至於衝擊力，其影響不到 17%。所以我認為我們正在做的就是逐漸減少它，我們正在嘗試透過我們的床邊支援和 SmartAssist 來最大程度地減少它。透過 Impella Connect 可以更輕鬆地管理患者，並將其儲存在雲端，這樣我們的專家、護士、呼叫中心、當地人員以及醫生就可以在不床邊的情況下檢查患者，然後定量地給出數字並跟踪它。

So I think all the things that you -- we've mentioned and you're pointing to, that does give us an advantage and allows the hospital to benefit from our services, and that's where this network approach, our ability to have the premier field team is really coming into play, and I think will continue to help us drive positive growth.

因此，我認為您所提到的和您指出的所有事情確實為我們帶來了優勢，並使醫院能夠從我們的服務中受益，這就是這種網絡方法的所在，我們有能力擁有一流的服務現場團隊正在真正發揮作用，我認為將繼續幫助我們推動積極成長。

And 1 quick follow-up on the BTR. That's really great news and a big step forward. I know it's very early, you're just talking about first-in-man, but this feels like something that could get breakthrough designation. So what should we be thinking as far as time to potential commercialization? I mean, are we still talking 5-plus years away? Or could it be sooner than that?

以及 BTR 的 1 個快速跟進。這確實是個好消息，也是向前邁出的一大步。我知道現在還為時過早，你只是在談論首次人類，但這感覺像是可以獲得突破性頭銜的東西。那麼，對於潛在商業化的時間，我們該考慮什麼呢？我的意思是，五年多後我們還在談論嗎？或可以比這更早嗎？

Danielle, the way we look at the early feasibility studies is it brings a technology into the U.S. years ahead of what it would have done in the old days. And we really want to credit the FDA for this really innovative and amazing program. It's actually transformed the medical device field. And what that also means to us is you can come in, and we will be applying for breakthrough for the BTR pump as well, which is similar to the ECP is it allows the FDA to prioritize, to put resources, to be flexible and to have a faster cycle, but allows you to enter in almost in like a prelaunch. And again, on all of these studies, as you get into the pivotals, you are -- it's a controlled study, but you are generating revenue. The hospitals are getting DRG payment. And in our own space, this is kind of how we launch anyhow.

丹妮爾，我們看待早期可行性研究的方式是，它將一項技術引入美國，比過去提前了幾年。我們真的要感謝 FDA 的這項真正創新和令人驚嘆的計劃。它實際上改變了醫療設備領域。這對我們來說也意味著你可以加入，我們也將申請 BTR 泵的突破，這與 ECP 類似，它允許 FDA 確定優先順序、投入資源、靈活並有更快的周期，但允許您幾乎像預啟動一樣進入。再說一次，在所有這些研究中，當你進入關鍵點時，你是——這是一項對照研究，但你正在創造收入。醫院正在獲得 DRG 付款。在我們自己的領域，這就是我們的發射方式。

We go slow and steady, because it's so important to learn to get great outcomes. And I kind of see it as somewhat of as a preclinical launch, but it puts this technology into the hands of these U.S. physicians, and it really helps drive this heart team approach. And as you can see from our portfolio, you now have products for the cath lab, surgical suite, EP lab and of course, the ICU, all running in the cloud. And I think that just is a great advantage for us to bring technology earlier into the U.S.

我們緩慢而穩定地前進，因為學習獲得偉大的成果非常重要。我認為它有點像臨床前發布，但它將這項技術交到這些美國醫生手中，它確實有助於推動這種心臟團隊的方法。正如您從我們的產品組合中看到的，您現在擁有用於導管實驗室、手術室、EP 實驗室，當然還有 ICU 的產品，所有這些產品都在雲端中運行。我認為這對我們更早將科技引入美國來說是一個巨大的優勢。

Our next question comes from Pito Chickering from Deutsche Bank.

我們的下一個問題來自德意志銀行的 Pito Chickering。

So 1 more guidance question here, and I do apologize, but focusing just on ICU capacity, hasn't that been getting better in October versus August and September. And why are you not seeing more improvement in October? And also what are you assuming around ICU capacity changing for November, December versus October?

因此，這裡還有 1 個指導問題，我確實表示歉意，但僅關注 ICU 容量，與 8 月和 9 月相比，10 月份的情況沒有好轉嗎？為什麼十月沒有看到更多改善？另外，您對 11 月、12 月與 10 月 ICU 容量的變化有何假設？

Yes, Pito, it's a good question. Thanks for it. I think obviously, we're tracking ICU capacity by city, by state, by hospital. And I think we are seeing improvement in a lot of areas over -- since what we saw in September heading into October. With that said, if you look at some of the states like Carolina -- the Carolinas, if you look at their ICU capacity over the last 6, 7, 8 days, they've gotten worse. And so I think this is going to be a lot of these areas where you're going to see areas like North Florida, Texas. Obviously, we've seen improvement in those metrics in the month of September as we get into October, but you see some other flare ups and like I said, Carolinas, some areas in Northern New England that are just continue to pop up.

是的，皮托，這是個好問題。謝謝你。我認為顯然，我們正在按城市、州和醫院追蹤 ICU 的容量。我認為自 9 月到 10 月以來，我們在許多領域都看到了改善。話雖如此，如果你看看卡羅萊納州等一些州——卡羅萊納州，如果你看看他們過去 6、7、8 天的 ICU 容量，你會發現情況變得更糟。所以我認為這將是很多這樣的地區，你會看到像北佛羅裡達州、德克薩斯州這樣的地區。顯然，隨著進入10 月份，我們在9 月份看到這些指標有所改善，但你會看到其他一些突發事件，就像我說的，卡羅萊納州、新英格蘭北部的一些地區繼續出現。

So overall, I'd say it's getting better. But we continue to believe that you'll see these hotspots pick up, especially as people move inside during the winter months and it might move up the coast a little bit. But again, it's something we're tracking every single day.

總的來說，我想說它正在變得更好。但我們仍然相信，您會看到這些熱點地區增加，特別是當人們在冬季搬進室內時，熱點地區可能會向海岸移動一點。但同樣，這是我們每天都在追蹤的事情。

Okay. Fair enough. For Impella growth going forward, we've seen a lot of hospitals start to use ECMO due to COVID that previously didn't use it. Do you think as hospitals become more use to mechanical support, that will help drive Impella adoption? And have you already begun seeing that?

好的。很公平。對於 Impella 的未來成長，我們看到許多醫院由於新冠肺炎而開始使用 ECMO，而以前從未使用過它。您認為隨著醫院越來越多地使用機械支持，這是否有助於推動 Impella 的採用？你已經開始看到這一點了嗎？

Pito, that is something we track. And again, we've done over 15,000 patients with ECpella over the years, and now we have our own ECMO products. So that trend will continue, but that trend works both ways. One is a physician that's struggling with a 14 French hole just on the Impella, which is a 9-French catheter. That's something that ECMO is 17 to 19 French large tubes all the way through. So there's definitely an intimidation and an issue there with bleeding in ECMO, that's in the literature as well as inflammatory response and risk of stroke.

Pito，這是我們追蹤的東西。再說一遍，多年來我們已經對 15,000 多名 ECpella 患者進行了治療，現在我們擁有自己的 ECMO 產品。因此，這種趨勢將持續下去，但這種趨勢是雙向的。一位醫生正在與 Impella（9 法式導管）上的 14 個法式孔作鬥爭。 ECMO 是 17 到 19 個法國大管子。因此，ECMO 中肯定存在出血問題，以及發炎反應和中風風險，這點在文獻中也有提及。

Relative to the overall process, I think it's good, because people are learning about mechanical circulatory support. People are thinking quicker about how do I get to that support. There's been a publication that talks about the centers that have shock teams. They do a better job of getting better outcomes. They technically talked about it, they use less and what they mean less is, they're using less probably escalation of inotropes and just balloon pumps, and they're moving quicker to the best practices of pre PCI in shock or escalating, looking for right heart failure or using ECMO or ECpella where you need oxygenation.

相對於整個過程，我認為很好，因為人們正在學習機械循環支援。人們正在更快地思考我如何獲得這種支持。有一份出版物談到了擁有突擊隊的中心。他們在獲得更好結果方面做得更好。他們從技術上討論了這一點，他們使用更少，他們的意思是，他們使用不太可能升級的正性肌力藥和球囊泵，並且他們正在更快地轉向PCI 前休克或升級的最佳實踐，尋找右心衰竭或需要氧合時使用 ECMO 或 ECpella。

So I think that's all been very positive. And again, on COVID, the majority of those patients are V-V ECMO. And so I think there's also some education that's been happening around just the oxygenation and the need for oxygenation versus cardiac support. So it's all been positive. And again, we continue to do everything we can to support patients, whether they have lung problems or heart problems.

所以我認為這一切都是非常正面的。同樣，對於新冠肺炎，大多數患者都採用 V-V ECMO。因此，我認為圍繞氧合以及氧合與心臟支持的需求也進行了一些教育。所以這一切都是正面的。再次強調，我們將繼續竭盡全力支持患者，無論他們有肺部問題還是心臟問題。

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。

This is Pavan Surabhi for Jayson Bedford. I had a quick question about -- so in the U.S., revenue grew 16%, but the patient usage trailed, growing only 8%. I think Todd mentioned about 400 points of that is from mix. But is there any other dynamics playing into that discrepancy between revenue growth and patient utilization?

我是傑森貝德福德 (Jayson Bedford) 的帕萬蘇拉比 (Pavan Surabhi)。我有一個簡單的問題：在美國，營收成長了 16%，但病患使用率卻落後，僅成長了 8%。我想 Todd 提到的大約 400 點來自 mix。但是，是否還有其他因素導致了收入成長和患者利用率之間的差異？

Yes. I can walk you through the high-level walk. So you're right, patients we're up 8% in the quarter. We did see about 4 points of favorable sales mix. So again, that's just the transition from Impella 5.0 to Impella 5.5 with SmartAssist as well as the continued switch from Impella 2.5 to CP, where we have higher average selling prices. So that's about 4 points of, I would say, top line growth. We did see a slightly higher reorder rate in the quarter, 101 versus 102, that's probably a point or 2. And then we had some higher deals in the quarter from a year-over-year perspective, and that would probably be another 1 point or 2. So that's really the walk from patients to revenue in the U.S.

是的。我可以引導您完成高級步行。所以你是對的，患者們，我們本季成長了 8%。我們確實看到了大約 4 個有利的銷售組合。再說一次，這只是從 Impella 5.0 到帶有 SmartAssist 的 Impella 5.5 的過渡，以及從 Impella 2.5 到 CP 的持續轉換，我們的平均售價更高。我想說，這大約是營收成長的 4 個百分點。我們確實看到本季度的再訂購率略高，分別為101 和102，這可能是1 點或2 點。然後，從同比角度來看，本季度我們有一些更高的交易，這可能又是1 點或 2. 這就是美國從患者到收入的真正過程。

Got it. Do you guys mind providing that for Europe as well, because I think we're seeing a similar dynamic there as well?

知道了。你們介意也為歐洲提供這項服務嗎，因為我認為我們在那裡也看到了類似的動態？

Yes. So in Europe, I would say it's a couple of things. It's -- again, we had some pretty solid growth in patients. We are seeing a little bit of a higher reorder rate in Europe, as a result, it's pretty lumpy. It goes from -- 1 quarter could be 94%. This quarter was a little over 100%. And so I would say it's reorder rates as well as we are seeing a benefit of some favorable sales mix over in Europe as well as we transition from CPC 7 to CPC 8 with SmartAssist, we are seeing a little bit of a price increase as well there. So a little bit of the same dynamic that we saw in U.S. we're seeing in Europe.

是的。所以在歐洲，我想說有幾件事。再次，我們的患者人數有了相當穩健的成長。我們看到歐洲的再訂購率上升，因此，情況相當不穩定。從 - 1 季起可能達到 94%。本季略高於 100%。因此，我想說的是再訂購率，我們看到歐洲一些有利的銷售組合帶來的好處，以及我們透過 SmartAssist 從 CPC 7 過渡到 CPC 8，我們也看到價格略有上漲那裡。我們在美國看到的動態與歐洲看到的有些相同。

That's helpful. You guys -- obviously, you guys have a plan to launch 5.5 in Japan. In terms of additional international expansion, is there a time line on 5.5 in Europe or any other new geographies you guys are targeting?

這很有幫助。你們——顯然，你們計劃在日本推出 5.5。就進一步的國際擴張而言，5.5 在歐洲或你們瞄準的任何其他新地區是否有時間表？

So 5.5 launched in Europe. So that is in Europe already. We are looking and bringing other technology to the rest of the world, which would be the RP with SmartAssist, our ECMO product and those geographies continue to grow.

因此 5.5 在歐洲推出。這已經是歐洲的事了。我們正在尋找其他技術並將其引入世界其他地區，這將是帶有 SmartAssist 的 RP、我們的 ECMO 產品，這些地區正在不斷增長。

That's helpful. And finally, with the XR Sheath 2.5. You guys launched about 2 quarters ago. How has that been doing? Have you guys seen any impact on volumes from that?

這很有幫助。最後是 XR Sheath 2.5。你們大約兩個季度前推出了。進展如何？你們看到這對銷量有什麼影響了嗎？

We commented on the last quarter that 51% of our high-risk PCI cases are now being done with a single access. So they do the procedure with the Impella and the PCI in the same femoral artery. That has been the preference. Our best users, our largest users, also want the Impella CP. They want the higher flow and the sensor capability. And they also want the option to be able to wean the patient either in the cath lab or in the ICU. So the focus right now is making the XR Sheath more compatible with single access and primarily for the Impella CP.

我們在上個季度表示，我們 51% 的高風險 PCI 病例現在都是透過單一訪問完成的。因此他們在同一股動脈中使用 Impella 和 PCI 進行手術。這是人們的偏好。我們最好的用戶、最大的用戶也需要 Impella CP。他們想要更高的流量和感測器功能。他們還希望能夠選擇在導管實驗室或 ICU 中為患者斷奶。因此，現在的重點是使 XR 護套與單通道更相容，主要用於 Impella CP。

Okay. And finally, this might be way too early for this, but is there any way you guys can frame the BTR market opportunity in terms of new patient population or additional TAM?

好的。最後，這可能還為時過早，但你們有什麼辦法可以根據新患者群體或額外的 TAM 來建立 BTR 市場機會嗎？

Sure. I mean we've talked about an additional 100,000 patients that we are looking to support as a combination between Impella 5.5 and Impella BTR. And that is a very conservative number out of the 1.6 million Class III and 400,000 Class IV patients that are looking to have the ability to feel better and also potentially get better. And that's a subset of what we would call the acute on chronic heart failure patients. Those are also the patients that are, I think, the second highest admission into the hospital. To some extent, we're going to start treating those patients earlier with preCARDIA, which is a preload reduction device that can be put in, in the ICU with the heart failure cardiologists. And for those that get worse, they may go on to 5.5. And for those that are just going to require longer-term support, the Impella BTR is not FDA approved, but that is the intent to go through the study to then utilize this technology for those patients as well.

當然。我的意思是，我們已經討論過，我們希望透過 Impella 5.5 和 Impella BTR 的組合為另外 100,000 名患者提供支援。在 160 萬 III 級患者和 40 萬名 IV 級患者中，這個數字非常保守，他們希望能夠感覺更好，也有可能好轉。這是我們所說的急性慢性心臟衰竭患者的一個子集。我認為，這些患者也是入院人數第二多的患者。在某種程度上，我們將開始使用 preCARDIA 更早治療這些患者，這是一種可以與心臟衰竭心臟科醫生一起放入 ICU 的預負荷減少裝置。對於那些變得更糟的人，他們可能會繼續到 5.5。對於那些只需要長期支持的患者，Impella BTR 尚未獲得 FDA 批准，但我們的目的是透過研究，然後將這項技術用於這些患者。

The LVAD technology is vastly improved over the years. However, it still requires a sternotomy and coring out of the left ventricle, and it doesn't provide forward flow. So in some cases, the valves are sewn shut. And what we're trying to do is give that patient and that physician full support with a minimally invasive axillary implant through the shoulder, allow the patient to get up and walk around and it buys them many options of recovery and other therapies that they can utilize.

多年來，LVAD 技術得到了極大的改進。然而，它仍然需要胸骨切開術和左心室取芯，而且它不提供前向血流。因此在某些情況下，閥門會被縫合關閉。我們正在努力做的是透過肩部微創腋窩植入物為患者和醫生提供充分支持，讓患者能夠站起來走動，這為他們提供了多種康復選擇和其他治療方法利用。

Our next question comes from Marie Thibault with BTIG from BTIG.

我們的下一個問題來自 BTIG 的 Marie Thibault。

I wanted to highlight a question here on 5.5. It certainly seem like a bright in the fiscal second quarter as it has for a few quarters now. And I wanted to try to see if you could parse out for us how much of a contribution that made to sort of the overall U.S. patient usage in the quarter? And whether there were any differences in dynamics between 5.5 usage and some of the CP usage as far as kind of COVID and nursing shortages?

我想在這裡強調一個關於 5.5 的問題。正如過去幾個季度一樣，第二財季的表現無疑是光明的。我想嘗試看看您能否為我們解析出該季度對美國患者整體使用量做出了多大貢獻？就新冠肺炎和護理人員短缺而言，5.5 的使用和某些 CP 使用之間的動態是否存在差異？

Sure, Marie. So just at a high level, the 5.5 individually grew 116% year-over-year and it was up 7% quarter-over-quarter. The entire surgical business, the 5.0, 5.5 grew 60%. We also had some growth in the Impella RP. And what your -- what the impact that it's having is we're becoming quite frankly, a preferred provider for heart surgeons, especially at the top center, Cedars, Northwestern, Cleveland Clinic, Hackensack as you go around the country. And we're not necessarily looking at it as a single product. We're looking at it as a way to solidify our partnership with the hospital and bringing the heart team together, because those surgeons also do high-risk CABG, where they potentially need support. And those surgeons in some cases, turn down patients that then get referred over for PCI.

當然，瑪麗。因此，就高水準而言，5.5 單獨同比增長 116%，環比增長 7%。整個外科業務，5.0、5.5成長了60%。我們在 Impella RP 方面也取得了一些成長。坦白說，它所產生的影響是，我們正在成為心臟外科醫生的首選提供者，尤其是在全國各地的頂級中心、雪松、西北、克利夫蘭診所、哈肯薩克。我們不一定將其視為單一產品。我們將其視為鞏固我們與醫院的合作夥伴關係並將心臟團隊聚集在一起的一種方式，因為這些外科醫生也進行高風險的冠狀動脈搭橋術，他們可能需要支持。在某些情況下，這些外科醫生會拒絕轉診接受 PCI 的患者。

One example is at Cleveland Clinic in their protocol, if you're an acute on chronic patient, so the patients I just talked about, you have worn out heart, you have advanced coronary disease and you decompensate. At that facility, they're likely going to stabilize you with a 5.5, then they're going to do an evaluation of what treatment they're going to do. And some of those patients go to the cath lab with the 5.5, some of those patients go to the EP lab with the 5.5 and some of those patients go on to CABG. And so it's really designing a protocol that allows for the ability to stabilize the patient, protect the heart and the kidneys, and then bring whatever treatment adjunctive therapies that's in the best interest of that patient. Todd could comment if he wants to make a point on the breakout on the numbers.

一個例子是克利夫蘭診所在他們的治療方案中，如果你是慢性病人的急性患者，那麼我剛才談到的病人，你的心臟已經疲憊不堪，你患有晚期冠心病，並且你的代償失調。在該機構，他們可能會將您的病情穩定在 5.5 分，然後他們將對將要進行的治療進行評估。其中一些患者帶著 5.5 去導管實驗室，一些患者帶著 5.5 去 EP 實驗室，還有一些患者繼續進行 CABG。因此，它實際上是在設計一種方案，使患者能夠穩定病情，保護心臟和腎臟，然後採取最符合患者最佳利益的輔助療法。如果托德想就數字的突破發表意見，他可以發表評論。

Yes, Marie, in terms of -- if you look at the U.S. surgical business, it represents about 18% of our revenue today. And of that, 5.5 is 92% of that makeup. So if you look at our growth in the quarter, I would say it's a combination of also opening new sites, but we're also treating 27% to 30% more on patients year-over-year.

是的，瑪麗，如果你看看美國的外科業務，它約占我們今天收入的 18%。其中，5.5 佔該構成的 92%。因此，如果你看看我們本季的成長，我會說這是開設新地點的結合，但我們治療的患者數量也比去年同期增加了 27% 至 30%。

That's really helpful detail. And then my second question here. We certainly heard a lot of other med tech companies talk about concerns about the supply chain, higher input cost inflation. Would love to hear what Abiomed is seeing and whether that's been baked into the margin outlook in some way?

這確實是很有幫助的細節。然後是我的第二個問題。我們當然聽到很多其他醫療科技公司談論對供應鏈、更高的投入成本通膨的擔憂。很想聽聽 Abiomed 所看到的情況以及這是否已以某種方式納入利潤前景？

Marie, thanks for that question. I want to complement our manufacturing and ops team for the resiliency. As you know, we have redundancy. We make the product here in Massachusetts and in Aachen, Germany. We're very focused on it, like everyone else, but the team continues to execute, but it's something that we monitor and pay close attention to. So I think what you're hearing from us is transparency in the quarter, but confidence in our innovation and our ability to continue to manufacture and supply our products.

瑪麗，謝謝你的提問。我想補充我們的製造和營運團隊的彈性。如您所知，我們有裁員。我們在馬薩諸塞州和德國亞琛生產該產品。和其他人一樣，我們非常關注它，但團隊仍在繼續執行，但這是我們監控和密切關注的事情。因此，我認為您從我們這裡聽到的是本季度的透明度，但對我們的創新以及我們繼續製造和供應產品的能力充滿信心。

I'm showing no further questions at this time. I would now like to turn the call back over to Mike Minogue for any closing remarks.

我目前沒有提出任何進一步的問題。我現在想將電話轉回給麥克·米洛，請他發表結束語。

Well, thank you, everyone, for your time today. And if you have any follow-up questions, we look forward to talking with you. Have a great day.

好的，謝謝大家今天抽出時間。如果您有任何後續問題，我們期待與您交談。祝你有美好的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a wonderful day.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。祝大家有美好的一天。