ABIOMED Inc (ABMD) 2004 Q4 法說會逐字稿

Good morning. My name is Jody and I will be your conference facilitator today. At this time, I would like to welcome everyone to the ABIOMED fiscal 2004 results conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer period. (OPERATOR INSTRUCTIONS)

早安.我叫喬迪，今天我將擔任你們的會議主持人。此時，我謹歡迎大家參加 ABIOMED 2004 財年業績電話會議。所有線路均已靜音，以防止任何背景噪音。演講者發言結束後，將進入問答環節。 （操作員說明）

I would now like to introduce ABIOMED's Vice President, Edward Berger. Sir, you may begin your conference.

現在我想介紹 ABIOMED 的副總裁 Edward Berger。先生，您可以開始會議了。

Thank you. Good morning. Welcome to ABIOMED's investor conference. This is Ed Berger, Vice President for Policy, Reimbursement and External Relations. I'm here this morning with Michael Minogue, ABIOMED's new Chief Executive Officer and President. Also with us today, our Chief Scientific Officer, Dr. Robert T.V. Kung; Vice President for Sales, Gene Rabe; and Chuck Haaser, ABIOMED's Controller and Acting Chief Financial Officer. The format for today's call will be as follows. First, Mike will provide you with an overview of significant current developments and future plans, as well as its prospective on ABIOMED after a little less than two months with the company. I will then provide a summary of the financial results for our fiscal 2004 ended March 31, and we will then open the call for your questions.

謝謝。早安.歡迎參加 ABIOMED 投資者會議。我是 Ed Berger，負責政策、報銷和對外關係的副總裁。今天早上我與 ABIOMED 新任執行長兼總裁 Michael Minogue 一起來到這裡。今天與我們一起出席的還有我們的首席科學官 Robert T.V. Kung 博士；銷售副總裁 Gene Rabe；以及 ABIOMED 的財務總監兼代理財務長 Chuck Haaser。今天電話會議的格式如下。首先，Mike 將向您概述當前的重大發展和未來計劃，以及在公司任職不到兩個月後對 ABIOMED 的展望。然後我將提供截至 3 月 31 日的 2004 財年財務業績摘要，然後我們將開始電話詢問您的問題。

First, though, it is necessary to remind you that during the course of this conference, we will be making forward-looking statements, including statements regarding future financial performance, product development efforts, ABIOMED's strategic and operational initiatives, and market response to our new products. ABIOMED's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development testing and related regulatory approvals, competition, technological change, future capital needs, and other risks detailed in the company's filings with the Securities and Exchange Commission, including our annual report on Form 10-K filed this morning. Investors are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this conference. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after this conference, or to reflect the occurrence of unanticipated events.

但首先，有必要提醒您，在本次會議期間，我們將做出前瞻性陳述，包括有關未來財務業績、產品開發工作、ABIOMED 的策略和營運舉措以及市場對我們新產品的反應的陳述。 。 ABIOMED 的實際結果可能與這些前瞻性聲明中的預期存在重大差異，具體取決於多種因素，包括與開發測試和相關監管審批相關的不確定性、競爭、技術變革、未來資本需求以及公司文件中詳述的其他風險與證券交易委員會，包括我們今天早上提交的 10-K 表格年度報告。請投資人不要過度依賴任何前瞻性陳述，這些陳述僅代表本次會議召開之日的情況。本公司沒有義務公開發布這些前瞻性陳述的任何修訂結果，這些修訂可能是為了反映本次會議後發生的事件或情況，或反映意外事件的發生。

Now, I'm very pleased to introduce Michael Minogue.

現在，我很高興向大家介紹麥可·米洛。

Thank you, Ed. Good morning everyone. I'm going to apologize upfront that I am going to go through what could be a long introduction, because I haven't had the opportunity to talk to a lot of investors yet. So I'm going to try and cover as much as I can, and again there will be questions at the end. So, first of all, I am extremely excited to be here today to talk about ABIOMED, its current position, as well as my view of its prospects. David Lederman recruited me from GE Medical Systems to come here to be his successor as the CEO and President. And going through the due diligence, I was impressed with the company's resources, all of the patents, and mostly the future potential. But I want to tell you today that after two months being immersed with the company and with our customers, and I have met many of the top customers already, I am even more optimistic than I was when I started. The one thing I would like to accomplish today is tell you why I'm so confident, but more importantly why I'm personally committed to unlocking the potential of ABIOMED to save lives, but also to go from a research company to a commercial global business.

謝謝你，艾德。大家，早安。我要預先道歉，我將進行可能很長的介紹，因為我還沒有機會與許多投資者交談。因此，我將盡力涵蓋盡可能多的內容，最後仍然會提出問題。因此，首先，我非常高興今天能夠在這裡談論 ABIOMED、其當前地位以及我對其前景的看法。 David Lederman 從 GE 醫療系統公司招募我來接替他擔任執行長兼總裁。透過盡職調查，我對公司的資源、所有專利以及主要的未來潛力印象深刻。但今天我想告訴大家，在與公司和客戶相處了兩個月之後，我已經結識了許多頂級客戶，我比剛開始時更樂觀。我今天想要完成的一件事是告訴你們為什麼我如此自信，但更重要的是為什麼我個人致力於釋放 ABIOMED 的潛力來拯救生命，同時也從一家研究公司轉變為商業全球公司商業。

I was present at the implant of patient 13 at Jewish Hospital, and I have to tell you that with the exception of the birth of my son, it was probably one of the most incredible experiences of my life. The goose bumps and the amazement to sit there and to see what this technology has accomplished was basically a religious event for me. It reinforces what I kind of knew, but this is a special place that has 22 years of dedication to a dream. Already, that dream, that vision, has produced five different products, which from the BVS Console to the BVS Blood Pump to the AB5000 Console to the new Ventricle, as well as the AbioCor II that is currently under development. But this company has 77 patents that are pending in related areas of circulatory care that go from wraps to valves to hundreds of other trade secrets for the AbioCor.

我在猶太醫院見證了 13 號病患的植入，我必須告訴你，除了我兒子的出生之外，這可能是我一生中最不可思議的經歷之一。坐在那裡看到這項技術所取得的成就，對我來說，起雞皮疙瘩和驚訝基本上是一件宗教事件。它強化了我的認知，但這是一個特別的地方，22年來一直致力於夢想。這個夢想、這個願景已經產生了五種不同的產品，從 BVS 控制台到 BVS 血泵、AB5000 控制台到新的心室，以及目前正在開發的 AbioCor II。但這家公司擁有 77 項正在申請的專利，涉及循環護理相關領域，從包裝材料到閥門，再到 AbioCor 的數百項其他商業機密。

So before we get into the details of last year, I just kind of wanted to outline some of the fiscal year '05 goals in anticipation of some of your questions. The first is, we have to have success, commercial success, on AB5000 Console as well as the Ventricles, and you'll see what we're talking about doing is continuing the success that happened in Q4. The second goal for this year is getting HDE, Humanitarian Device Exemption, approval for the AbioCor so that we can move to commercial product within the U.S., as well as expanding it outside of the U.S. The third is continuing on the development and progress for AbioCor II, and having on plan that we will be doing implants in the lab of AbioCor II. Fourth is to continue to acquire and buy and develop new core competencies in circulatory care, that we are going to continue with the goal that has been put in the past of being profitable in fiscal year '05, without any exception unless, of course, we make a major acquisition.

因此，在我們詳細介紹去年的情況之前，我只是想先概述一下 05 財年的一些目標，以回應你們的一些問題。首先，我們必須在 AB5000 主機和 Ventricles 上取得成功，商業上的成功，您會看到我們正在談論的事情是繼續第四季度發生的成功。今年的第二個目標是 AbioCor 獲得 HDE（人道主義設備豁免）批准，以便我們可以在美國境內轉向商業產品，並將其擴展到美國境外。第三個目標是繼續 AbioCor 的開發和進步II，並計畫在AbioCor II 實驗室進行植入。第四是繼續獲得、購買和開發循環護理方面的新核心能力，我們將繼續實現過去設定的在 05 財年實現盈利的目標，無一例外，當然，除非，我們進行了一項重大收購。

So those are our short-term goals, and those things are going to help drive our longer-term vision. And the way we see our vision as a company is we want to be the clear leader for all short-term to long-term circulatory care. Anything in that space that goes from the patient to the cath lab to OR to discharge to home monitoring, that is going to be our focus. We also want to make sure that everyone knows that the focus in the core competency here has really been innovator and a clear technology leader for the total artificial heart, which to date we are still the total artificial heart on the market, and we have also acquired the rights to the Penn State heart. So the AbioCor II will encompass both those technologies and the best of both.

這些是我們的短期目標，這些目標將有助於推動我們的長期願景。我們對公司願景的看法是，我們希望成為所有短期到長期循環護理領域的明確領導者。從患者到導管實驗室、手術室、出院到家庭監護，該空間中的任何事情都將成為我們的重點。我們還想確保每個人都知道，這裡核心競爭力的重點確實是全人工心臟的創新者和明確的技術領導者，迄今為止，我們仍然是市場上的全人工心臟，而且我們也獲得了賓夕法尼亞州立大學心臟的權利。因此，AbioCor II 將涵蓋這兩種技術以及兩者的優點。

The third is the market for the total artificial heart is over a $1 billion market. We're going to be positioned, have the right strategy and processes that will enable us to capture the majority of that market. On the longer-term, we expect to be a $500 million company within 7 years. If you look at the size of the market, you look at the growth rates that we're seeing from third parties, on just VAD market to total artificial market, we think it is within the grasp. And last, which is most important of all, is the people. We have to have a culture here that is inspiring, that rewards employees, that recognizes meritocracy, and this is a special place that saves lives and we're going to be doing that.

第三個是整個人工心臟的市場超過10億美元的市場。我們將做好定位，制定正確的策略和流程，使我們能夠佔領該​​市場的大部分份額。從長遠來看，我們預計在 7 年內成為一家價值 5 億美元的公司。如果你看看市場的規模，看看我們從第三方看到的成長率，從 VAD 市場到整個人工市場，我們認為這是可以掌握的。最後，也是最重要的，是人。我們這裡必須有一個鼓舞人心、獎勵員工、認可菁英管理的文化，這是一個拯救生命的特殊地方，我們會這樣做。

So we have kind of a daily mantra here that these are the things we do each day, these are the focuses, and it comes around all of those encompassed into saving lives, leading always in technology innovation, becoming profitable, and having a winning culture. As we execute on our strategy, the outlook for the future gets me personally excited about the impact we can have on the lives of thousands of people all over the world. Now imagine filling up Fenway Park more than twice and being able to help keep alive that amount of people.

因此，我們這裡有一種日常口號，這些是我們每天做的事情，這些是重點，它圍繞著拯救生命、始終領先技術創新、盈利和擁有製勝文化的所有內容。 。當我們執行我們的策略時，未來的前景讓我個人對我們能夠對全世界成千上萬人的生活產生的影響感到興奮。現在想像一下，芬威球場被填滿兩次以上，並且能夠幫助這麼多人生存。

I think we have already made some good starts, and I won't take the time to describe each of all of the initiatives, but I would like to touch on a couple of things. I am very pleased by the enthusiasm and the reception of the ABIOMED's entire workforce. The people are dealing with a lot of change, but they are doing it constructively and they're doing it without sacrificing short-term productivity. I do want to also tell you that we have already strengthened our management team with the addition of several key individuals who bring with them from GE Medical a very high level of skill with processes and disciplines we need here. We will be formally introducing these individuals in a press release fairly soon, but I'm extremely pleased that these talented people have recognized our great opportunity and have chosen to join ABIOMED. Together with the very talented individuals on David Lederman's management team, I believe we're really close to have assembled a team with most of the competencies we need for success.

我認為我們已經取得了一些良好的開端，我不會花時間描述每一項舉措，但我想談談一些事情。我對 ABIOMED 全體員工的熱情和接待感到非常高興。人們正在應對許多變革，但他們正在建設性地進行變革，並且不會犧牲短期生產力。我還想告訴您，我們已經加強了我們的管理團隊，增加了幾位關鍵人員，他們從 GE Medical 帶來了我們這裡所需的流程和紀律方面的高水平技能。我們很快就會在新聞稿中正式介紹這些人，但我非常高興這些才華橫溢的人認識到我們的絕佳機會並選擇加入 ABIOMED。與 David Lederman 管理團隊中非常有才華的個人一起，我相信我們已經非常接近組建一支具備成功所需的大部分能力的團隊。

We're actively working to strengthen our organization as well today, and what we're doing is expanding our field sales team from the current of 9 salesforce to 14 in order to provide better coverage for the accounts with also our new products and our growth targets. We're also adding distribution outside of the U.S., specifically Latin America, Europe, Japan, and China, and in those markets the BVS Blood Pump provides the most cost-effective solution, whether it's used with the BVS Console or the AB5000 Console. And the same reason that it's been so successful in the U.S., the BVS is approximately in 100 out of 104 transplant centers, is the same reason why we think we will have rapid growth outside of the U.S.

今天，我們也在積極努力加強我們的組織，我們正在做的是將我們的現場銷售團隊從目前的 9 名銷售人員擴大到 14 名，以便透過我們的新產品和成長更好地覆蓋客戶目標。我們還增加了美國以外的分銷，特別是拉丁美洲、歐洲、日本和中國，在這些市場中，BVS 血泵提供了最具成本效益的解決方案，無論是與BVS 控制台還是AB5000 控制台一起使用。 BVS 在美國如此成功，約佔 104 個移植中心中的 100 個，這也是我們認為我們將在美國以外地區快速成長的原因。

On the clinical side, we intend to make similar increases. Our clinical people are extraordinarily talented and dedicated, but they have been spread too thin to provide the quality of customer support and education that we want and need to provide. We have the best technology in the industry and we have the best people. Our goal is now to provide the highest level of customer support, and we will be formally relaunching our service business to provide media, marketing, reimbursement, and patient care support and analysis to our customers.

在臨床方面，我們打算進行類似的增加。我們的臨床人員非常有才華和奉獻精神，但他們的分佈太分散，無法提供我們想要和需要提供的優質客戶支援和教育。我們擁有業界最好的技術，我們擁有最優秀的人才。我們現在的目標是提供最高水準的客戶支援，我們將正式重新啟動我們的服務業務，為客戶提供媒體、行銷、報銷以及患者護理支援和分析。

In regard to our products, the AB5000 represents the next generation of consoles. If you think about all the other consoles that are out there in the world including our BVS, the equivalent analogy is they're built basically on a calculator platform. As we move forward, our new console is a laptop computer which will enable updates, remote diagnostics, and future software programs to be added to them. With regard to our early sales experience in the AB5000 in Q4, the results are outstanding; 27 percent growth over prior Q4. That is just outstanding. Our record revenue quarter still prior to the full market release of the Ventricle was in large measure a result of the enthusiasm of our customer response.

就我們的產品而言，AB5000 代表了下一代遊戲機。如果您考慮世界上所有其他控制台（包括我們的 BVS），等效的類比是它們基本上是建構在計算器平台上。隨著我們的前進，我們的新控制台是一台筆記型電腦，它將支援更新、遠端診斷和添加未來的軟體程式。就我們第四季AB5000的早期銷售經驗來看，成績非常出色；比上一季成長 27%。這真是太出色了。在 Ventricle 全面上市之前，我們創紀錄的營收季度在很大程度上歸功於我們客戶的熱情響應。

I personally now have visited over 20 centers at the most prestigious places, and I can personally testify that the customers really value and are giving us higher rankings across the board on the product from the Console to the Ventricle itself on its reliability, on its performance. I believe that the AB5000 is going to be a strong competitor in the market, and I think it is going to be an engine for our revenue growth and cash, as well as profitability for the ABIOMED company.

我個人現在已經參觀了 20 多個最負盛名的中心，我可以親自證明，客戶確實重視我們的產品，並在從控制台到心室本身的可靠性和性能方面給予我們更高的全面排名。我相信 AB5000 將成為市場上的強大競爭對手，我認為它將成為我們收入成長和現金以及 ABIOMED 公司獲利能力的引擎。

Now the AB5000 Console is a breakthrough, and why it is a breakthrough is because today on that console, it can be used with one or two BVS Blood Pumps for short-term, or it can be used with one to two -- or it can be used with one blood pump as well as the ventricle for the AB5000, or it can be used for two ventricles from the AB5000. So you have total flexibility based on the customer decision point, as well as the patient needs. The console immediately recognizes which pump it is attached, once the proper connection has been made. The patient can have a BVS Blood Pump changed to an AB5000 bag at bedside without having another invasive operation. This is an exclusive only to ABIOMED, as well as having one console that enables full support and the capability for the patient to walk around the hospital.

現在AB5000控制台是一個突破，為什麼它是一個突破是因為今天在那個控制台上，它可以短期與一兩個BVS血泵一起使用，或者可以與一到兩個一起使用——或者它可以與一個血泵以及AB5000 的心室一起使用，也可以與AB5000 的兩個心室一起使用。因此，您可以根據客戶決策點以及患者需求擁有完全的靈活性。正確連接後，控制台會立即辨識所連接的幫浦。患者可以在床邊將 BVS 血泵更換為 AB5000 血袋，而無需再次進行侵入性手術。這是 ABIOMED 獨有的，並且擁有一個控制台，可以為患者提供全面支援並能夠在醫院周圍走動。

If you look at the design of the console itself, it is built on a platform with wheels that actually can be used almost as a walker, and for transportation you basically can remove it completely from the wheel mechanism, and it has wheels on the bottom and a handle like a luggage cart. So if you want to ambulate the patient, load him in a helicopter or move him around, it has that full capability without having to provide two consoles like other vendors offer. No matter what, though, this gives the patients what they need, and it provides physicians the best possible range of choices that are the least cost, the least discomfort, the least trauma, and no other company in the industry today can follow this model.

如果你看一下控制臺本身的設計，它是建立在一個帶輪子的平台上，實際上幾乎可以用作助行器，並且為了運輸，你基本上可以將其完全從輪子機構中移除，並且它的底部有輪子還有一個像行李車一樣的把手。因此，如果您想要移動患者、將他裝載到直升機上或移動他，它具有完整的功能，而無需像其他供應商提供的那樣提供兩個控制台。但無論如何，這都能滿足患者的需要，也為醫生提供了最佳的選擇範圍，即成本最低、不適感最小、創傷最小，當今業內沒有其他公司可以效仿這種模式。

Now, in regard to the AbioCor, most of you are already aware that we announce patient 14 this week, as well as patient 13 at Jewish hospital. And I apologize for not giving their names, but our company policy is to protect their privacy until they decide to release more information. We were all very pleased by the recent progress in the trial, progress that keeps us tracking toward our goal of HDE by year-end. While there is no patient specific information that we can provide to you about the recent implants, I will say that we are learning a great deal every day, and what we are learning is very encouraging. Through experience of Jay Croft who was patient number 12, we had over 60 days of support, and we know that he did not have any evidence of stroking and we were able to inspect the explanted AbioCor. I would like to thank Jay and has family for helping us move closer to our goal of saving thousands of lives. Our prayers, our thoughts, our sympathy, are with the family, and we understand and want to thank you for the support you made. We will provide further information on all the patients in the future reports as well, and we will be giving a day coming here in the next 30 days with more media attention.

現在，關於 AbioCor，你們大多數人已經知道我們本週宣布了第 14 號患者，以及猶太醫院的第 13 號患者。我很抱歉沒有透露他們的名字，但我們公司的政策是保護他們的隱私，直到他們決定發布更多資訊。我們對試驗最近的進展感到非常高興，這些進展使我們能夠在年底前實現 HDE 的目標。雖然我們無法向您提供有關最近植入物的患者俱體信息，但我想說的是，我們每天都在學習很多東西，而且我們所學到的東西非常令人鼓舞。根據 12 號患者 Jay Croft 的經驗，我們獲得了超過 60 天的支持，我們知道他沒有任何中風的證據，我們能夠檢查取出的 AbioCor。我要感謝傑伊和他的家人幫助我們更接近拯救數千人生命的目標。我們的祈禱、我們的思念、我們的同情都與家人同在，我們理解並感謝你們所給予的支持。我們也將在未來的報告中提供有關所有患者的更多信息，並且我們將在未來 30 天內在這裡提供一天，以獲得更多媒體關注。

The AbioCor and the AbioCor II are keys to our long-range business outlook. They are major drivers of our revenues and profits in the future, and no matter how you look at the analysis, if you say there is 50,000 to 150,000 worldwide patient, it is well over a $1 billion market, because cardiovascular disease continues to be the number one killer in every country today, and it will continue in the future.

AbioCor 和 AbioCor II 是我們長期業務前景的關鍵。它們是我們未來收入和利潤的主要驅動力，無論你如何看待分析，如果你說全球有 50,000 到 150,000 名患者，那麼這個市場遠遠超過 10 億美元，因為心血管疾病仍然是最重要的市場。當今每個國家的頭號殺手，並且在未來仍將如此。

The financial terms of fiscal year 2004, it was a good year with some growth and substantial improvements in overall operating results as measured by greatly reduced net loss and our continued reduction of cash consumption, and we have approximately 45 million in short to long-term cash ready for us to use for different acquisitions or growth currently today. We're tracking toward our previously announced goal of turning the corner into profitability during the final quarter of fiscal year 2005, assuming no substantial technology acquisitions or new investment, and we're working hard to continue to grow our revenues, rationalize operations, take costs off out of our products, and improve on our already high standards of customer service in support of that goal.

就2004 財年的財務狀況而言，這是一個良好的一年，整體經營業績有所增長和顯著改善，具體表現為淨虧損大幅減少和現金消耗持續減少，我們的短期和長期資金約為4500 萬美元。目前，我們已準備好現金用於不同的收購或成長。我們正在朝著先前宣布的目標邁進，即在 2005 財年最後一個季度扭虧為盈，假設沒有大量的技術收購或新的投資，我們正在努力繼續增加我們的收入，合理化運營，採取降低我們產品的成本，並提高我們已經很高的客戶服務標準，以支持這一目標。

I have allocated the first 60 days to immerse myself into the company and customers, of which I want to thank all of the customers that are listening, and thank all of the employees for teaching me so much. I'm in the learning mode, and I have just been so impressed with the character and the dedication of this team, and I want to thank them for allowing me to be here and to serve as the CEO. But over the next 90 days, I look forward to meeting all of the major investors and analysts in person, and I'm going to be focused on having a continuous dialogue with you in the future to ensure that our story is told. Thank you for your interest, and I look forward to working with you, meeting you in person, and more questions later on.

我分配了前 60 天的時間讓自己沉浸在公司和客戶中，其中我要感謝所有正在傾聽的客戶，並感謝所有員工教會了我這麼多。我正處於學習模式，這個團隊的個性和奉獻精神給我留下了深刻的印象，我要感謝他們允許我來到這裡並擔任執行長。但在接下來的 90 天裡，我期待與所有主要投資者和分析師親自會面，我將專注於在未來與你們進行持續對話，以確保我們的故事得到講述。感謝您的關注，我期待與您合作，親自與您會面，並稍後提出更多問題。

Thank you, Mike. Financial highlights of fiscal 2004 as detailed in our annual report on Form 10-K filed with the SEC this morning include the following. Total revenues for ABIOMED's fiscal 2004 were $25.7 million, 10 percent above the prior-year. Year's results were highlighted by a record fourth quarter of $8.6 million, 27 percent higher than the 6.8 million in revenues in the comparable quarter of the prior-year. Quarter-by-quarter comparisons of fiscal 2004 to our fiscal 2003 may be found in a supplemental financial statement schedule included in this morning's Form 10-K filing.

謝謝你，麥克。我們今天上午向 SEC 提交的 10-K 表格年度報告中詳細介紹了 2004 財年的財務要點，其中包括以下內容。 ABIOMED 2004 財年的總營收為 2,570 萬美元，較上年成長 10%。今年的業績突顯在第四季創紀錄的 860 萬美元收入，比去年同期的 680 萬美元收入高出 27%。 2004 財年與 2003 財年的逐季比較可以在今天上午提交的 10-K 表格中包含的補充財務報表表中找到。

Product revenues for the year increased by 2 million or 8 percent from 23.1 million in fiscal 2003 to 25.1 million in fiscal 2004. The increase is attributable to sales of AB5000 Consoles and Ventricles during the controlled clinical rollout that began in the first fiscal quarter for the console and in the second fiscal quarter for the ventricle. Product revenue reflects fulfillments of all of the sales backlog reported at the end of our third quarter. Going forward, we expect total revenue growth in excess of 10 percent annually, driven by sales of AB5000 Consoles and Ventricles, subsequent to the full product rollout in April of 2004. Revenue growth may be concentrated in the second half of the current fiscal year.

該年度的產品收入增加了200 萬件，即8%，從2003 財年的2310 萬件增加到2004 財年的2510 萬件。這一增長歸因於從第一財季開始的受控臨床推廣期間AB5000 控制台和心室的銷售。控制台和第二財季的心室。產品收入反映了第三季末報告的所有銷售積壓的履行。展望未來，在 2004 年 4 月全面推出產品後，我們預計在 AB5000 控制台和心室銷售的推動下，總收入每年增長超過 10%。收入增長可能集中在本財年下半年。

We also expect that the BVS will remain an important part of our heart product portfolio as we anticipate continuing demand for BVS blood pumps. Domestic sales accounted for 92 percent of total product revenue during fiscal 2004, and 94 percent of product revenue for fiscal 2003. With regard to funded research and development revenue, contract revenues increased by 0.5 million to 0.7 million in fiscal 2004, from 0.2 million in fiscal 2003. As of March 31, 2004, our total backlog of research and development contracts and grants was $0.3 million.

我們也預計 BVS 仍將是我們心臟產品組合的重要組成部分，因為我們預計對 BVS 血泵的需求將持續成長。 2004 年財年國內銷售佔產品總收入的92%，2003財年佔產品收入的94%。在資助研發收入方面，合約收入從2004財年的20萬增加到2004財年的70萬。2003 財年。截至2004 年3 月31 日，我們的研發合約和贈款積壓總額為30 萬美元。

Looking at cost of product revenues, cost of product revenues as a percentage of product revenues improved to 30 percent for fiscal 2004 from 32 percent in fiscal 2003. The improvement in margin is primarily the result of lower manufacturing costs, increased sales as a result of the introduction of the new AB5000 system, and a write-down of inventory of an older model of the BVS Console to its net realizable value during the prior year. We expect that the growth of AB5000 product revenues will support continued market improvement in future reporting periods.

從產品收入成本來看，產品收入成本佔產品收入的百分比從 2003 財年的 32% 提高到 2004 財年的 30%。利潤率的提高主要是由於製造成本降低、銷售額增加（由於引入新的AB5000 系統，並將舊型號BVS 控制台的庫存減記至前一年的可變現淨值。我們預計 AB5000 產品收入的成長將支持未來報告期間市場的持續改善。

Research and development expenses decreased by 6.3 million or 30 percent, from 20.6 million in fiscal 2003 to 14.3 million in fiscal 2004. Research and development expenses were 80 percent of total revenues for fiscal 2003, and 56 percent of total revenues in fiscal 2004. The largest portion of this decrease is attributable to research and development expenses incurred for the AbioCor. Reduction is primarily due to labor and material purchases related to manufacturer of AbioCor units, as well as development and testing activity.

研究與開發費用減少了630 萬美元，即30%，從2003 財年的2,060 萬美元減少到2004 財年的1,430 萬美元。研究與開發費用佔2003 財年總收入的80%，2004 財年佔總收入的56%。這一下降的最大部分歸因於 AbioCor 的研發費用。減少主要是由於與 AbioCor 裝置製造商相關的勞動力和材料採購，以及開發和測試活動。

Research and development expense for fiscal 2004 also included costs associated with ongoing development of the AB5000, including costs associated with efforts to obtain regulatory approval for our new AB5000 Ventricle, as well as those associated with future heart-assist blood pumps and canuli that are expected to operate with the new AB5000 Console platform. Also included in research and development expense during fiscal 2004 are lesser costs associated with continued development and testing of the AbioCor II. We anticipate that the majority of our near-term R&D focus will be on further extending the AB5000 product line, completing the initial AbioCor clinical trial, and securing approval of the Humanitarian Device Exemption for initial commercial introduction of the AbioCor, and developing the AbioCor II.

2004 財年的研發費用還包括與 AB5000 的持續開發相關的成本，其中包括與我們新的 AB5000 心室獲得監管部門批准的相關成本，以及與預期的未來心臟輔助血泵和套管相關的成本與新的AB5000 控制台平台一起操作。 2004 財年的研發費用中還包括與 AbioCor II 的持續開發和測試相關的較少成本。我們預計，我們近期的大部分研發重點將是進一步擴展 AB5000 產品線、完成初始 AbioCor 臨床試驗、獲得人道主義器材豁免批准以進行 AbioCor 的首次商業推廣，以及開發 AbioCor II 。

SG&A expenses decreased by 0.6 million or 4 percent, from 14.7 million in the prior year to 14.1 million in the fiscal year ended March 31, 2004. This reduction is attributable to lower accounting and legal costs, as well as reduction in selling and clinical support costs. As we plan to increase both sales and clinical support staffing in order to support the ongoing rollout of the AB5000 product, selling and clinical support costs are likely to increase going forward.

截至2004 年3 月31 日的財政年度，SG&A 費用減少了60 萬美元，即4%，從上一年度的1,470 萬美元減少到1,410 萬美元。這一減少歸因於會計和法律成本的降低，以及銷售和臨床支援的減少。成本。由於我們計劃增加銷售和臨床支援人員以支援 AB5000 產品的持續推出，因此未來銷售和臨床支援成本可能會增加。

Other income consists primarily of interest earned on our investment balances net of expenses and foreign exchange gain or loss. Interest and other income was $0.8 million in fiscal 2004, a decrease of 0.5 million from the 1.3 million in fiscal 2003. This decrease was primarily due to reduce yields on investments resulting from lower average interest rates and lower average fund balances available for investment. As a result of our improving financial performance and the continuing reduction in research and development expenditures as the AbioCor approaches initial commercial introduction, we were able during fiscal 2004 to move some of our cash and short-term assets into longer-term instruments in order to improve future yields. Foreign translation costs were nearly constant year to year.

其他收入主要包括我們的投資餘額扣除費用和外匯損益後賺取的利息。 2004 財年的利息和其他收入為80 萬美元，比2003 財年的130 萬美元減少了50 萬美元。這一減少主要是由於平均利率下降和可用於投資的平均資金餘額減少導致投資收益率下降。由於我們的財務表現有所改善，並且隨著 AbioCor 接近首次商業推廣，我們不斷減少研發支出，因此我們能夠在 2004 財年將部分現金和短期資產轉移到長期工具中，以便提高未來的產量。外文翻譯費用每年幾乎維持不變。

Finally, net loss for the fiscal year ended March 31, 2004 was approximately $9.4 million or 45 cents per share. This is a 48 percent reduction from the net loss of approximately 18.2 million or 87 cents per share in the prior fiscal year. The losses for both years are primarily attributable to development in clinical testing costs associated with the AbioCor, the AbioCor II, the AB5000 Circulatory Assist System, and cost of developing other technologies and products. Continued reduction of our net loss is an important goal of management, and we anticipate, absent a substantial acquisition or other new technology investment, moving into profitability before the end of fiscal 2005.

最後，截至 2004 年 3 月 31 日的財政年度淨虧損約為 940 萬美元，即每股 45 美分。這比上一財年約 1,820 萬美元（即每股 87 美分）的淨虧損減少了 48%。兩年的虧損主要歸因於與 AbioCor、AbioCor II、AB5000 循環輔助系統相關的臨床測試成本的開發，以及開發其他技術和產品的成本。持續減少淨虧損是管理層的重要目標，我們預計，如果沒有大量收購或其他新技術投資，我們將在 2005 財年結束之前實現盈利。

That concludes our formal presentation. We would like now to turn the call back to you for your questions. Thank you.

我們的正式演講到此結束。我們現在想將電話轉回給您詢問您的問題。謝謝。

(OPERATOR INSTRUCTIONS) William Frain (ph) from UBS.

（操作員說明）來自 UBS 的 William Frain (ph)。

Good morning everybody. Mike, a very big welcome to you. Most people know that I have been around since 1984, and I'm celebrating my 20th year here with ABIOMED, and I go on mass (ph). But I guess my biggest question regarding the AB5000 is, can and will it be approved for BTT, bridge to transplant, in the future?

大家早安。麥克，非常歡迎你。大多數人都知道我從 1984 年就開始工作了，現在我正在慶祝我在 ABIOMED 工作的 20 週年，我會做彌撒（ph）。但我想我對 AB5000 最大的問題是，未來它是否能夠並且會被批准用於 BTT（移植的橋樑）？

This is William?

這是威廉?

William Frain.

威廉·弗萊恩.

Hi, William. How are you?

嗨，威廉。你好嗎？

Good, Mike, thank you.

好的，麥克，謝謝你。

Thank you for the welcome. If you look at the way that the trend happens as essentially the BVS started, people will use them how they want to use them at the transplant centers, and the concern is how long and how reliable. We are going to be submitting for formal classification of bridge to transplant. However, we have already had -- I think it's seven patients have been supported on the AB5000 today that have been taken to a transplant. And if you look at the testing on it, we're beyond 90 days on the system itself, is reliability, and we actually just get our benchmark testing on the product at one year for reliability.

謝謝您的歡迎。如果你看看這種趨勢在 BVS 開始時發生的方式，人們會在移植中心按照他們想要的方式使用它們，而關心的是多長時間和有多可靠。我們將提交要移植的橋樑的正式分類。然而，我認為今天已經有 7 名患者接受了 AB5000 的支持，並接受了移植手術。如果你看一下它的測試，我們對系統本身的可靠性已經超過了 90 天，實際上我們只是在一年內對產品進行了可靠性基準測試。

So the answer to your question is, yes, that is the plan, and we already have customers out there today that are using it for that. And whether you get coded a DRG for bridge-to-transplant or bridge-to-recovery, you have the same reimbursement. It is up to the hospital site to decide which one they use.

所以你的問題的答案是，是的，這就是計劃，我們今天已經有客戶正在使用它。無論您的 DRG 編碼為橋接移植還是橋接恢復，您都可以獲得相同的報銷。由醫院現場決定使用哪一種。

Thank you very much.

非常感謝。

Robert Larson (ph) from Lyons Asset Management.

來自里昂資產管理公司的羅伯特·拉森（博士）。

That's close and I'm fine. Mike, welcome. Congratulations on a great quarter, guys. Could you go through or elaborate on the HD application process? Is it something that's lengthy, is it something that you feel you can still get accomplished this year if you complete the next transplant or two or implant that you need to do? Just elaborate in general on how you think you can have some commercial sales in fiscal -- excuse me, calendar 2005 of the AbioCor?

已經很接近了，我很好。麥克，歡迎。夥計們，恭喜你們度過了一個出色的季度。能詳細介紹一下HD申請流程嗎？這是一件很漫長的事情嗎？如果您完成下一次或兩次需要做的移植或植入，您認為今年仍然可以完成這件事嗎？請概括地闡述您認為如何在財政年度實現一些商業銷售——請問，AbioCor 的日曆是 2005 年嗎？

Sure. First of all, Robert, thank you for the welcome. I look forward to meeting you in person here quickly. I'm going to turn part of the question over to Bob, but I'm just going to give a quick update on the HDE. We also plan on expanding the use of the AbioCor outside of the U.S. So, obviously, within Europe and those areas it won't require that. But from what we're looking at where we are on our milestones, we are confident still in hitting that time frame. Bob, if you want to comment?

當然。首先，羅伯特，感謝您的歡迎。我期待盡快在這裡與您見面。我會把問題的一部分轉交給 Bob，但我只是簡單介紹一下 HDE 的最新情況。我們也計劃在美國以外擴大 AbioCor 的使用。因此，顯然，在歐洲和那些不需要這樣做的地區。但從我們目前的里程碑來看，我們仍然有信心達到這個時間框架。鮑勃，你想發表評論嗎？

Yes, just to give you a sense of an idea of what the process is, in order to -- well, first the Humanitarian Device Exemption is an approach where the patient population that it has been limited to is 4000 in the United States. Now, in order to get to that point, the first step that we have to do is call humanitarian use destination for the device. Now that is an approval step which you have to get first. That we actually got in September of last year. So with that first step accomplished, the next step for us is to actually -- is to send in the application for the HDE. By the way, when I said 4000, it's 4000 per year in the United States, okay? So, obviously, the initial introduction of the AbioCor once we get the HDE approval, there is a limit in the patient population, but 4000 is naturally a very large number to start out with.

是的，只是為了讓您了解這個過程是什麼，為了——嗯，首先，人道主義設備豁免是一種將美國的患者人數限制為 4000 人的方法。現在，為了達到這一點，我們要做的第一步是調用該設備的人道主義使用目的地。現在這是您必須先獲得的批准步驟。我們實際上是在去年九月得到的。因此，第一步完成後，我們的下一步實際上是發送 HDE 申請。對了，我說的4000，是美國每年4000，好嗎？因此，顯然，一旦我們獲得 HDE 批准，最初引入 AbioCor 的患者人數是有限的，但 4000 人自然是一個非常大的數字。

One other comment on that, Robert, is 4000 per year, and what we are likely to do is we're going to pick a select group of folks. We're not going to roll it out to all of the centers. We'll take the top centers of excellence and ask to have people funneled to those facilities for those procedures. Once we do have HDE approval, we can commercially sell the product as we would if we had FDA approval for total commercial.

羅伯特對此的另一個評論是每年 4000 人，我們可能會選擇一組精選的人。我們不會將其推廣到所有中心。我們將選擇頂級的卓越中心，並要求將人員集中到這些設施進行這些程序。一旦我們獲得 HDE 批准，我們就可以像獲得 FDA 全面商業批准一樣對產品進行商業銷售。

Right, but the periods that they take, the FDA or whoever does, to grant the approval on the HDE is not one of these one or two-year contentious debates, is it, or is it?

是的，但是 FDA 或任何機構批准 HDE 所需的時間並不是這些一年或兩年的有爭議的辯論之一，是嗎？

No, typically the process, there is a 75-day response time from the FDA. So this is as opposed to the 180 days that normally is the first step in a PMA application.

不會，通常情況下，FDA 會有 75 天的回應時間。因此，這與 PMA 申請第一步通常需要的 180 天不同。

Great. In a different area, GAAP profitability for the business would imply around $10 million of quarterly revenue with where your staffing is today. I assume if it is in the fourth quarter of fiscal '05, it is closer to 11 million. Am I right in my math if I want to assume you guys breaking even on a GAAP basis at some point in fiscal '05, having to do 10 to $11 million in revenue?

偉大的。在另一個領域，按照 GAAP 會計準則計算，企業的獲利能力意味著按照目前的員工配置，季度收入約為 1,000 萬美元。我假設如果是 05 財年第四季度，則接近 1,100 萬。如果我想假設你們在 05 財年的某個時候按照 GAAP 原則實現收支平衡，並且必須實現 10 至 1100 萬美元的收入，那麼我的數學計算是否正確？

Good question. The way I would answer that is we're going to be focused on growth in certain areas, and we're going to be looking at an overall topline growth of 10 percent or greater, but we're comfortable saying double-digit growth of 10 percent, as well as we're going to be taking out some cash. We're going to manage our cash flow, we're going to manage our inventory. We're going to try and expand our distribution, so there's other opportunities outside of the U.S. as well.

好問題。我的回答是，我們將專注於某些領域的成長，我們將尋求 10% 或更高的整體營收成長，但我們可以放心地說，兩位數的成長10%，我們還要拿出一些現金。我們將管理我們的現金流，我們將管理我們的庫存。我們將嘗試擴大我們的分銷範圍，因此在美國以外還有其他機會。

But if all I did was grow the revenues 10 percent, I don't get close to the breakeven on a GAAP basis. So you guys can lowball all you want, but you can't get from point A to point B without materially higher revenue growth than 10 percent.

但如果我所做的只是將收入成長 10%，那麼以 GAAP 計算，我就無法達到收支平衡。所以你們可以壓低你們想要的一切，但如果收入成長率不高於 10%，你們就無法從 A 點到達 B 點。

Correct.

正確的。

Thank you very much.

非常感謝。

Randy Huff (ph) from Lion's Share Financial.

來自 Lion's Share Financial 的 Randy Huff（博士）。

Thank you for the excellent overview. I, like Bill Frain, have been involved in the story since the mid '80s. He is much older than I am, though, I wanted to mention, and is looking forward to results -- positive results faster than I'm willing to wait. But anyway, I represent not only myself but another long-term investor, Ernie Burgess (ph), out on the West Coast, also an investment advisor who was unable to be on the call. So let me ask his question first so I can hold true to my pledge. He would like to get an update on the AbioCor II, in terms of both your level of optimism with respect to the potential success of that device, albeit in the lab, and a timeline if you're ready to give one on when you thought you might be filing, assuming you're going to file a PMA for the AbioCor II, what that timeline might look like?

感謝您精彩的概述。我和比爾·弗萊恩一樣，從 80 年代中期開始就參與了這個故事。不過，我想提一下，他比我大得多，並且期待著結果——正面的結果比我願意等待的更快。但無論如何，我不僅代表我自己，還代表另一位長期投資者厄尼·伯吉斯（Ernie Burgess），他在西海岸，也是一名無法參加電話會議的投資顧問。所以讓我先問他的問題，這樣我才能兌現我的承諾。他想了解 AbioCor II 的最新情況，包括您對該設備潛在成功的樂觀程度（儘管是在實驗室中），以及時間表（如果您準備好在您認為什麼時候提供）您可能正在提交，假設您要為AbioCor II 提交PMA，那麼時間表可能會是什麼樣子？

Sure. Well, I'll give you some generic, but then we also are planning on doing an update of the AbioCor as well as the AbioCor II in the short-term future. But just on the timeline for it, this fiscal year '05, one of the goals is to implant into cows, and so we are on track for that. Based on our production, I don't think there's been any significant change from what we have shown in the past and prior annual reports, as far as the time frame itself. As a confidence level, obviously I am pretty confident in it. We do have them running right now in our engineering labs, and the goal for them continues to be reliability of 5 years, to be able to take 30 percent of the size off and then decrease the cost for the existing AbioCor I today.

當然。好吧，我會給您一些通用的信息，但我們還計劃在短期內對 AbioCor 和 AbioCor II 進行更新。但就其時間表而言，即本財年 05 年，目標之一是植入乳牛體內，因此我們正在朝著這個目標邁進。根據我們的製作，我認為就時間範圍本身而言，我們在過去和之前的年度報告中所顯示的內容沒有任何重大變化。作為一個信心水平，顯然我對此很有信心。我們現在確實讓它們在我們的工程實驗室中運行，它們的目標仍然是 5 年的可靠性，能夠縮小 30% 的尺寸，然後降低現有 AbioCor I 的成本。

Okay. So we can expect a little more clarity in terms of the timeline here in the not too distant future?

好的。那麼我們可以期待在不久的將來時間安排會更加清晰嗎？

Correct.

正確的。

Then on to my question. It looks like the AB5000 has the potential to be very successful for you. I know when I visited the company last July and met with Ed Berger, we get some pretty exciting information on what your view was of market penetration opportunities or the penetrable market, I guess is the way it was termed, for temporary assist devices. So maybe this question could be directed to, it's either you, Mike, or Gene, but looking at a 7-year out revenue run rate of 500 million that you commented earlier, is that -- how are you coming up with that number, given the early rollout success in terms of number of implantations this quickly?

然後回答我的問題。看來 AB5000 有潛力為您帶來巨大成功。我知道，當我去年七月訪問該公司並會見埃德·伯傑時，我們得到了一些非常令人興奮的信息，關於您對市場滲透機會或可滲透市場的看法，我想這就是臨時輔助設備的術語。所以也許這個問題可以針對你，邁克，或者吉恩，但是看看你之前評論的 7 年收入運行率 5 億，你是如何得出這個數字的，鑑於早期推出的成功以及如此快的植入數量？

Two, something that hasn't been discussed and I've asked before, Mike, is can you disclose pricing per unit at this point, now that you're fully commercializing the AB5000 Ventricle?

第二，麥克，我之前問過，尚未討論過的事情是，既然您已將 AB5000 心室完全商業化，您現在能否透露每單位的定價？

That is a great question, Randy. I'm glad you asked that. If you look at today, and we do have a third-party report by the Health Research Institute; it's the 2004 March report. If you look at the market today, according to them it says that the U.S. only market is $143 million, and it says it is going to grow 43 percent every year until year 2008, which the VAD market is then $605 million. If you then take out where our strengths, our strategy, in the short-term today of that $143 million market, 83 percent of that market exists in the short-term 5-day to 90-day period, 83 percent. That is where our strength is, because we can have a cost-effective approach from a blood pump at a spoke hospital, and then they can transport that patient, keep them alive to the transplant center and go ahead and change them to the AB5000 VAD without having to open the patient up. That's such an enormous opportunity for productivity, for patient care, for quality, that we feel like we have a very strong position short-term.

這是一個很好的問題，蘭迪。我很高興你這麼問。如果你看看今天，我們確實有健康研究所的第三方報告；這是2004年3月的報告。如果你看看今天的市場，根據他們的說法，光是美國市場就有 1.43 億美元，而且到 2008 年，每年都會成長 43%，屆時 VAD 市場將達到 6.05 億美元。如果你把我們的優勢、我們的策略放在今天這個 1.43 億美元市場的短期內，那麼這個市場的 83% 存在於 5 天到 90 天的短期內，83%。這就是我們的優勢所在，因為我們可以透過分行醫院的血泵採取一種經濟高效的方法，然後他們可以將患者運送到移植中心，讓他們活著到移植中心，然後將他們更換為 AB5000 VAD無需打開病人的身體。對於生產力、病患照護和品質來說，這是一個巨大的機會，我們覺得我們在短期內擁有非常強大的地位。

Now, as it evolves and if you look at their market, it shifts from the short-term of today until 2008 to a market that becomes 70 percent destination therapy. So, according to them, today 83 percent is on the short-term, but by 2008, 70 percent will be in the destination therapy market, which means there is no alternative, these people are not going to get a heart, a natural heart. And the only other market, the only other products that are out there today are products that provide the left pump support only. No matter what you do, there are certain people you can't predict if the left pump is working or not working, will they have a problem with the right pump. That is why as it evolves and as we get our products out there on AbioCor I to AbioCor II, we will be in another strong position by 2008, and at this point now the market is over 1 billion worldwide.

現在，隨著它的發展，如果你觀察他們的市場，你會發現它從今天到 2008 年的短期市場轉變為 70% 的目標療法市場。因此，根據他們的說法，今天 83% 是短期治療，但到 2008 年，70% 將進入目的地治療市場，這意味著別無選擇，這些人不會獲得心臟，自然心臟。當今唯一的其他市場、唯一的其他產品是僅提供左泵支撐的產品。無論您做什麼，有些人您都無法預測左泵是否工作，右泵是否會出現問題。這就是為什麼隨著它的發展以及我們在 AbioCor I 到 AbioCor II 上推出我們的產品，到 2008 年我們將處於另一個強勢地位，目前全球市場已超過 10 億。

So we're going to become a global business, we're going to expand, and in addition to the growth rates that we're looking at from the market, we also are going to have some price increases on certain components because we are still the most cost-effective choice from the blood pump to the VAD. And on our console selection, it only requires one console that enables the patient to have the support and the reliability they need, as well as to walk around with that console to support them, whereas other vendors require them to switch from one console to the other. That is kind of the way we see our market growing.

因此，我們將成為一家全球性企業，我們將擴張，除了我們從市場上看到的成長率之外，我們還將對某些組件進行一些價格上漲，因為我們仍然是從血泵到VAD 的最具成本效益的選擇。在我們的控制台選擇上，它只需要一台控制台，使患者能夠獲得所需的支持和可靠性，並帶著該控制台四處走動以支持他們，而其他供應商則要求他們從一台控制台切換到另一台控制台。其他。這就是我們看待市場成長的方式。

On top of that, there will likely be certain technologies we have today that we can license, and there's also likely to be one or two opportunities down the road that we choose to expand to acquire to expand our portfolio into circulatory care.

最重要的是，我們今天擁有的某些技術可能是可以授權的，我們也可能會選擇擴大收購的一兩個機會，以將我們的產品組合擴展到循環護理領域。

Great. The last part of my question concerned the pricing on these new ventricles. Are you ready to disclose what the range is on the pricing?

偉大的。我問題的最後一部分涉及這些新心室的定價。您準備好透露定價範圍了嗎？

What I would say is we are competitively priced, and we are below where the competition is for their like VADs. And in the case of the blood pump, there is no other competitor in that price point or market or function. The only other alternative is a VAD, and our VAD is actually lower priced then the competition's, and again we only require one console in order to run both of those products.

我想說的是，我們的價格具有競爭力，而且我們的價格低於同類 VAD 的競爭水平。就血泵而言，在該價位、市場或功能上沒有其他競爭對手。唯一的其他選擇是 VAD，我們的 VAD 實際上比競爭對手的價格更低，而且我們只需要一個控制台即可運行這兩種產品。

Okay, thank you. Just a comment to Gene. Gene, I'm sure you're very excited about the introduction and rollout success so far, if you could comment?

好的謝謝。只是對吉恩的評論。 Gene，我相信您對迄今為止的引入和推出成功感到非常興奮，您能發表評論嗎？

Randy, I would be glad to. From the standpoint of all of these calls in the past, we have a very tenured field team, both sales and clinical. And I've been spending a lot of time in the field regarding the original controlled launch, and now under the official launch that just occurred here in April. The excitement in the team and from our customers is unbelievable. The product is exceptional, it works flawlessly. The patients that we support and the positive outcomes and the endpoints, we just don't have enough time in the day right now, Randy. And hence, as Michael mentioned, we're expanding that field team, both sales and clinical, with this official launch. So I'm excited and logging a lot of miles on planes, as well as the field team is just all-out pace right now.

蘭迪，我很樂意。從過去所有這些電話的角度來看，我們擁有一支非常資深的現場團隊，包括銷售和臨床團隊。我在最初的受控發射領域花費了大量時間，現在又在四月剛進行的正式發射中。團隊和客戶的興奮程度令人難以置信。該產品非常出色，工作完美。我們支持的患者以及積極的結果和終點，我們現在沒有足夠的時間，蘭迪。因此，正如邁克爾所提到的，隨著此次正式發布，我們正在擴大銷售和臨床領域的現場團隊。所以我很興奮，在飛機上記錄了很多英里，而且現場團隊現在正在全力以赴。

Thank you for that and good luck to you. Mike, I look forward to meeting you sometime soon.

謝謝你，祝你好運。麥克，我期待很快見到你。

Thanks, looking forward to meeting you.

謝謝，期待與您見面。

(OPERATOR INSTRUCTIONS) Philip Harris (ph) with A.G. Edwards.

（操作員說明）Philip Harris (ph) 和 A.G. Edwards。

Your current approval requires that you implant your device in patients who have a life expectancy, I believe, of 30 days or less. How will that change under the Humanitarian Device Exemption (indiscernible)?

您目前的批准要求您將設備植入預期壽命為 30 天或更短的患者。在人道主義設備豁免下，這種情況將如何變化（音頻不清）？

This is Ed Berger. Under the Humanitarian Device Exemption which will, pending final FDA approval, specify a total population and the characteristics of that population, we will be dealing with patients who in terms of the diagnoses and the lack of any alternative effective therapy are very much like the patients in the clinical trial, but there will be no requirements for calculating how soon they are likely to die. Therefore, in all probability, we will get a substantial number of patients under the HDE who are not on the precipice of death, within two or three or five days, as has characterized the very great majority of the patients enrolled in the clinical trial.

這是艾德·伯傑。根據人道主義設備豁免，在 FDA 最終批准之前，該豁免將指定總人口和該人口的特徵，我們將處理與患者在診斷和缺乏任何替代有效治療方面非常相似的患者在臨床試驗中，但不會要求計算他們可能多久就會死亡。因此，很可能，我們將在兩、三或五天內獲得 HDE 下的大量患者，他們不會像參加臨床試驗的絕大多數患者那樣處於死亡邊緣。

To say that they will be less sick is probably not to do justice to the fact that they will all be -- have dire and terminal heart failure with no help from anything else, but they will not be as fragile and as close to the end because we will not have to measure the probability of death within any particular time frame.

說他們的病情會減輕可能並不能公正地對待這樣一個事實：他們都會在沒有任何其他幫助的情況下患有嚴重的晚期心臟衰竭，但他們不會那麼脆弱，也不會那麼接近死亡。因為我們不必測量任何特定時間範圍內的死亡機率。

A follow-up question, how will the criteria for selecting a person for the ABIOMED, how will those criteria differ from the criteria that are used to select a person for a transplant?

後續問題是，選擇 ABIOMED 人員的標準如何，這些標準與選擇移植人員的標準有何不同？

By definition under the HDE, if a patient is eligible for transplantation, they are eligible for another already approved and very efficacious therapy, and they would, therefore, not be eligible as part of the HDE as the defined humanitarian use population.

根據 HDE 的定義，如果患者符合移植資格，他們就有資格接受另一種已批准且非常有效的治療，因此，他們不符合 HDE 規定的人道主義使用人群的資格。

Okay. Thank you very much.

好的。非常感謝。

Okay.

好的。

Robert Larson from Lyons Asset Management.

里昂資產管理公司的羅伯特·拉森。

Thanks for the follow-up. Back on the AB5000, the BVS is in approximately 700 hospitals globally and you're at 30, I guess, already for the AB5000. Could you elaborate as to how many potential hospitals are candidates for buying the console and using the product? Is it the same 700 or is it a product that would have a smaller market? Thank you.

感謝您的跟進。回到 AB5000，全球大約有 700 家醫院使用了 BVS，我猜，AB5000 已經有 30 家了。您能否詳細說明有多少潛在醫院適合購買該控制台並使用該產品？是同一個 700 還是市場更小的產品？謝謝。

Robert, I'll be glad to answer that. As we look at the number of open-heart programs just in the United States, that number is around 930 open-heart programs currently. There are about 1000 outside of the United States in the rest of the world. So from the standpoint of the BVS as well as the Ventricle and the AB5000 Console, all of those hospitals are potential customers. As you indicated regarding those numbers, we currently have about 700 worldwide BVS customers. Those are all possible customers for the new technology, and all hospitals that do not have the BVS currently are candidates for the AB5000 technology. So it is every program that performs open-heart surgery throughout the world is a potential customer with the existing product line and the brand-new product we just launched.

羅伯特，我很樂意回答這個問題。當我們看看美國的開心項目數量時，目前這個數字約為 930 個。美國以外的世界其他地區大約有1000個。因此，從 BVS 以及 Ventricle 和 AB5000 控制台的角度來看，所有這些醫院都是潛在客戶。正如您對這些數字所指出的，我們目前在全球擁有約 700 個 BVS 客戶。這些都是新技術的可能客戶，目前所有沒有 BVS 的醫院都是 AB5000 技術的候選人。因此，全世界每一個進行心臟直視手術的項目都是現有產品線和我們剛推出的全新產品的潛在客戶。

Thank you very much.

非常感謝。

Rob McClaine (ph) from UBS.

瑞銀 (UBS) 的 Rob McClaine（博士）。

As a follow-up on the earlier question, with the consent issue and the HDE, what would be the earliest do you think an AMI patient would be a candidate for the AbioCor?

作為先前問題的後續問題，考慮到同意問題和 HDE，您認為 AMI 患者最早什麼時候可以成為 AbioCor 的候選者？

You're talking about after we have the HDE approval?

你是說我們獲得 HDE 批准後嗎？

Yes.

是的。

I think it's -- number one, I think it's up to the choice of the surgeon and the cardiologist to decide when they become it, but technically the avenue that they could be supported on could be a ventricle-assist device to see if the heart can recover, and/or from that decision the doctor could choose to put the patient into as a candidate for the AbioCor immediately, and then that would be something that we would offer as an option.

我認為第一，我認為這取決於外科醫生和心臟病專家的選擇來決定他們何時成為這樣的人，但從技術上講，他們可以得到支持的途徑可能是心室輔助裝置，以查看心臟是否可以康復，和/或根據該決定，醫生可以選擇立即將患者作為AbioCor 的候選者，然後這將是我們提供的選擇。

The only alternative to that is if the patient looks -- if the right population -- you have to understand from the AMI or heart attack population, you're going to get a group that doesn't have the other organ trouble that the longer-term patients that we have today. So we would want to insure that the doctors go through the process of one recovery which could mean the VAD. Two could be a normal, natural heart transplant, and then third would be the capability to then go to the AbioCor.

唯一的選擇是，如果患者看起來——如果是正確的人群——你必須從 AMI 或心臟病發作人群中了解，你將得到一組沒有其他器官問題的群體，時間越長我們今天擁有的足月患者。因此，我們希望確保醫生能夠完成一次康復過程，這可能意味著 VAD。其中兩個可能是正常的、自然的心臟移植，第三個可能是能夠進行 AbioCor。

Thank you.

謝謝。

John Sherrod (ph) of Sherrod (ph) & Company.

Sherrod (ph) & Company 的 John Sherrod (ph)。

Hi, Mike. I also am looking forward to meeting you sometime in the not too distant future. There has been several references to numbers of years of investing in ABIOMED. All I would say is that I can't remember when I didn't own stock in ABIOMED, it's so long. Someone earlier asked the question about the $500 million that you mentioned in seven years. They asked how you arrived at that, what is the breakdown. And I don't think that anybody answered that.

嗨，麥克。我也期待在不久的將來與您見面。有多次提及對 ABIOMED 多年的投資。我想說的是，我不記得我什麼時候沒有持有 ABIOMED 的股票了，時間太長了。剛才有人問你提到的七年5億美元的問題。他們問你是如何得出這個結論的，故障是什麼。我認為沒有人回答這個問題。

Sure. I can walk through. Let's say that for 500 within seven years, and you just look at incremental -- if you look at the increments of the business today, today's market for the VAD market is $143 million. In 2008, it is going to be 605 just in the U.S. So that is less than seven years. And then if you look at the market opportunity, today's market of that 143, 83 percent is in where our core products are today, which is the BVS, the blood pump and the AB5000, and again this is only U.S. numbers for the market. Once we get to HDE and from the AbioCor I to the AbioCor II, just to pick a simple math, let's say the market is -- let's say just the AbioCor market is $1 billion. We don't have to get all of it, but if we do 250 or we do 500 or if we do 1000, you're now looking at a range just on that alone of 100 to $300 million, and then you add on the top of the VAD market itself, where we will be at with that.

當然。我可以走過去假設七年內有 500 家公司，您只看增量 - 如果您看一下今天業務的增量，今天的 VAD 市場價值為 1.43 億美元。 2008 年，光是美國就有 605 個，所以這還不到七年。然後，如果你看看市場機會，今天的 143 個市場，其中 83% 是我們今天的核心產品，即 BVS、血泵和 AB5000，而這也只是美國市場的數字。一旦我們談到 HDE，從 AbioCor I 到 AbioCor II，只需選擇一個簡單的數學，假設市場是 - 假設 AbioCor 市場是 10 億美元。我們不必得到全部，但如果我們做 250 或我們做 500 或如果我們做 1000，你現在看到的只是 100 到 3 億美元的範圍，然後你加上VAD 市場本身的頂部，我們將在那裡。

I missed that when you said if there's a $1 billion market, you said you'd do 250 or 500 million? But then you dropped down to 100 million.

我錯過了，當你說如果有一個 10 億美元的市場時，你說你會做 250 或 5 億？但後來你就跌到1億了。

Yes. See, it is based on -- what we're going to do is we're going to have a controlled rollout of the AbioCor at certain centers, and the amount that we ramp up is going to be based on the reliability and the target we have for the AbioCor I, followed by our size and our rollout for AbioCor II. But the market is there where today -- let's say the market between the VADs and the AbioCor, let's say it's 2 billion, $3 billion by that time globally, our share then to get to 500 would not be even a significant share.

是的。看，它是基於——我們要做的是，我們將在某些中心有控制地推出 AbioCor，並且我們增加的數量將基於可靠性和目標我們先介紹了AbioCor I，然後介紹了AbioCor II 的規模和推出情況。但今天的市場就在那裡——假設 VAD 和 AbioCor 之間的市場，假設到那時全球範圍內有 20 億、30 億美元，那麼我們的份額達到 500 甚至不會是一個重要的份額。

Well, that's the reason I was wondering why it was such a low number.

嗯，這就是我想知道為什麼這個數字這麼低的原因。

Well, I appreciate your optimism, and I think what I said is 500 million minimum -- well, maybe I didn't say it, but the goal is 500 million in less than seven years.

嗯，我很欣賞你的樂觀態度，我想我所說的最低限度是 5 億——好吧，也許我沒有說，但目標是在不到七年的時間內達到 5 億。

I don't think you did say it as a minimum.

我認為你至少沒有這麼說。

Well, I will clarify that. Thank you for bringing it up. I agree with you, and the one thing I want to be sure and you will see when I'm out meeting with all of the investors, is I'm going to be realistic about the size of the market and then the size that we're going to play in as we ramp up manufacturing. We want to insure that this is a controlled, successful rollout, and as we get healthier patients we believe you're going to see even a longer period of time on reliability and the mobility, and most importantly the quality of life for these patients.

好吧，我會澄清這一點。謝謝你提出來。我同意你的觀點，我想確定的一件事是，當我與所有投資者會面時，你會看到，我將對市場的規模以及我們的規模保持現實的態度。當我們擴大製造業時，它們將會發揮作用。我們希望確保這是一次受控、成功的推廣，隨著患者變得更健康，我們相信您將看到更長的時間可靠性和移動性，最重要的是這些患者的生活品質。

I understand that you want to be conservative on it and I have no problem with that, but you mentioned the $500 million figure and I just wanted to know what went into that because it obviously is exceedingly small penetration of what seems to be the market. You mentioned $2 billion, $3 billion. So that just gives some idea about a company with a great product and not much competition, there is a pretty good chance that that would be overly conservative.

我知道你想對此保持保守，我對此沒有問題，但你提到了 5 億美元的數字，我只是想知道其中的內容，因為它顯然對市場的滲透率非常小。你提到20億美元、30億美元。因此，這只是給出了關於一家擁有出色產品且競爭不多的公司的一些想法，很有可能過於保守。

One, I would say God bless you for that, and two, I would say I agree with you, but we're going to be conservative until we put more numbers on the board and share the results.

第一，我會說上帝保佑你，第二，我會說我同意你的觀點，但我們會保持保守，直到我們在董事會上公佈更多數字並分享結果。

I think that is just fine.

我認為這樣就很好了。

At this time, there are no further questions. Gentlemen, are there any closing remarks?

目前，沒有其他問題了。先生們，有什麼結束語嗎？

No, thank you. Thank you all very much for joining us. We look forward to future conferences and future reports on our progress. Thank you.

不，謝謝。非常感謝大家加入我們。我們期待未來的會議和未來關於我們進展的報告。謝謝。

Thank you. This concludes today's conference call. You may now disconnect.

謝謝。今天的電話會議到此結束。您現在可以斷開連線。