ABIOMED Inc (ABMD) 2015 Q4 法說會逐字稿

Good day ladies and gentlemen, and welcome to the Abiomed Q4 2015 earnings conference call.

女士們、先生們，大家好，歡迎參加 Abiomed 2015 年第四季財報電話會議。

(Operator Instructions)

（操作員說明）

As a reminder, today's conference call is being recorded. I would now like to turn the conference over to Ingrid Goldberg, Director of Investor Relations, please go ahead.

提醒一下，今天的電話會議正在錄音。現在我想將會議交給投資者關係總監 Ingrid Goldberg，請繼續。

Good morning. Welcome to Abiomed's fourth quarter of FY15 earnings conference call. This is Ingrid Goldberg, Director of Investor Relations for Abiomed. And, I am here with Mike Minogue, Abiomed's Chairman, President and Chief Executive Officer; and Bob Bowen, Vice President and Chief Financial Officer.

早安.歡迎參加 Abiomed 2015 財年第四季財報電話會議。我是 Ingrid Goldberg，Abiomed 投資者關係總監。我和 Abiomed 董事長、總裁兼執行長 Mike Minogue 一起來到這裡。以及副總裁兼財務長鮑勃鮑文 (Bob Bowen)。

The format for today's call will be as well follows: First, Mike will discuss strategic highlights from the fourth fiscal quarter, and full fiscal year, and then turn it to our key operational and strategic objectives. Next, Bob will provide details on the financial results outlined in today's press release. We will then open the call to your questions.

今天電話會議的格式也如下：首先，麥克將討論第四財季和整個財年的戰略亮點，然後轉向我們的關鍵營運和戰略目標。接下來，鮑勃將提供今天新聞稿中概述的財務業績的詳細資訊。然後我們將開始電話詢問您的問題。

Before turning the call over to Mike, I would like to remind everyone on the call that this presentation includes forward-looking statements about the development of Abiomed's existing and new products. The Company's progress towards commercial growth and future financial performance, as well as future opportunities, and expected regulatory approvals. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements.

在將電話轉給 Mike 之前，我想提醒參加電話會議的每個人，本簡報包含有關 Abiomed 現有產品和新產品開發的前瞻性陳述。公司在商業成長和未來財務表現方面的進展，以及未來的機會和預期的監管批准。本簡報中包含的每項前瞻性陳述均面臨風險和不確定性，可能導致實際結果與此類陳述中的預測有重大差異。

Additional information regarding these factors appears in the heading forward-looking statements, in the press release we issued this morning. And in part one, item 1A risk factors, in our annual report on form 10-K, for the year ended March 31, 2014. And part two, item 1A risk factors, in our quarterly report on form 10-Q, for the quarter ended March 31, 2014, which are filed with the SEC, and available at SEC.gov, and also on our website at www.Abiomed.com.

有關這些因素的更多資​​訊出現在我們今天早上發布的新聞稿中的前瞻性聲明中。在第一部分，第1A 項風險因素，在我們的10-K 表格年度報告中，截至2014 年3 月31 日。第二部分，第1A 項風險因素，在我們的10-Q 表格季度報告中，為截至 2014 年 3 月 31 日的季度報告已向 SEC 備案，可在 SEC.gov 以及我們的網站 www.Abiomed.com 上取得。

The forward-looking statements in this presentation speak only to the original day of this presentation, and we undertake no obligation to update or revise any of these statements. Thank you for joining us. I'm now pleased to introduce Abiomed's Chairman, President and Chief Executive Officer, Mike Minogue.

本簡報中的前瞻性聲明僅針對本簡報的原始日期，我們不承擔更新或修改任何這些陳述的義務。感謝您加入我們。現在我很高興介紹 Abiomed 董事長、總裁兼執行長 Mike Minogue。

Thank you, Ingrid. Good morning, everyone. Abiomed had another breakout quarter, signifying the acceleration of Impella into the adoption curve. I am proud of our employees, and grateful to our dedicated customers, that allowed our Company to achieve our best ever quarterly results, with $67.6 million in revenue and 34% in growth.

謝謝你，英格麗。大家，早安。 Abiomed 的季度又取得了突破，這意味著 Impella 加速進入採用曲線。我為我們的員工感到自豪，並感謝我們熱忱的客戶，他們使我們公司實現了有史以來最好的季度業績，收入達 6760 萬美元，增長率為 34%。

US patient utilization set new highs, with a robust 42% growth rate, driven by record number of patients in prophylactic and emergent support. It is worth noting that high-risk PCI, with Impella support, what Abiomed now refers to as protected PCI, grew 53%. These outstanding results, prior to our PMA approval, validate the FDA recognition of the growing clinical need and new patient population. This first of it's kind FDA approval makes Impella the only safe and effective percutaneous circulatory support device for the high-risk PCI indication.

在預防性和緊急支持患者數量創紀錄的推動下，美國患者利用率創下了新高，成長率高達 42%。值得注意的是，在 Impella 的支持下，高風險 PCI（Abiomed 現在稱為受保護 PCI）增加了 53%。在我們獲得 PMA 批准之前，這些出色的結果驗證了 FDA 對不斷增長的臨床需求和新患者群體的認可。 FDA 的首次批准使 Impella 成為唯一安全有效的用於高風險 PCI 適應症的經皮循環支援設備。

Abiomed has now grown top-line revenue, double digits, year over year, for 22 straight quarters. And, our results demonstrate the incredible potential of Impella becoming the standard of care in the United States. We are committed to this ultimate goal. And we'll continue to prioritize, and invest in our field and headquarters capabilities, while maintaining rigor and discipline in our training and product launches.

Abiomed 目前已連續 22 季實現營收兩位數年成長。而且，我們的結果證明了 Impella 成為美國護理標準的巨大潛力。我們致力於實現這一最終目標。我們將繼續優先考慮並投資我們的現場和總部能力，同時在我們的培訓和產品發布中保持嚴格和紀律。

For today's call, we will first provide an update on the size of the market opportunity for protected PCI, in the elective and urgent population. And second, expand upon some of our post market approval, marketing and educational programs. The elective and urgent high-risk PCI market is a growing population for the cath lab, which we estimate at over 50,000 patients in the United States.

在今天的電話會議中，我們將首先提供有關選擇性和緊急人群中受保護 PCI 市場機會規模的最新資訊。其次，擴展我們的一些上市後批准、行銷和教育計劃。選擇性和緊急的高風險 PCI 市場是導管實驗室的人口不斷增長的市場，我們估計美國有超過 50,000 名患者。

These patients may benefit from PCI, but have poor heart function, complex coronary artery disease and comorbidities, that likely require hemodynamic support for complete revascularization in high-risk intervention. Most of this patient population has likely been turned down, or not considered for surgery, by a heart team, because of their age or prior surgical risk factors.

這些患者可能會從 PCI 中受益，但心臟功能較差，患有複雜的冠狀動脈疾病和合併症，可能需要血流動力學支持才能在高風險幹預中實現完全血管重建。由於年齡或先前手術風險因素，大多數患者可能被心臟團隊拒絕或不考慮進行手術。

The Impella approval allows for more focus on these patients, that may not have other options. And/or may be unaware of the benefits of protective PCI. We have amassed a library of clinical data, with over 225 publications referencing three FDA studies, our Impella registry and real-world usage.

Impella 的批准使我們能夠更專注於這些可能沒有其他選擇的患者。和/或可能不知道保護性 PCI 的好處。我們累積了一個臨床資料庫，其中有超過 225 篇出版物引用了三項 FDA 研究、我們的 Impella 註冊和實際使用情況。

In addition, Impella has supported over 25,000 US patients, and was referenced in our sixth AHA/ACC guideline. However, prior to the FDA approval, we were limited in educating the broader physician community and patients. This has changed, effective immediately.

此外，Impella 已為超過 25,000 名美國患者提供支持，並在我們的第六份 AHA/ACC 指南中被引用。然而，在 FDA 批准之前，我們對更廣泛的醫生群體和患者的教育受到限制。這已經改變，立即生效。

For the first time, Abiomed will now be able to assist our users in the patient identification process, and highlight the clinical benefits of protected PCI, with a 29% reduction in [maiths], a 58% reduction in heart failure classification, and a 52% reduction in repeat procedures. With a PMA for high risk PCI, the FDA has acknowledged this elective in urgent patient population.

Abiomed 現在將首次能夠在患者識別過程中協助我們的用戶，並強調受保護 PCI 的臨床益處，[maiths] 減少 29%，心臟衰竭分類減少 58%，並且重複程序減少 52%。透過針對高風險 PCI 的 PMA，FDA 認可了緊急患者群體中的這種選擇性。

In an effort to demonstrate the significance of the approval, the following outlines some of our new programs. We are now able to provide direct education and training, to interventional and referring cardiologist, on how to identify and treat patients that may benefit from protected PCI. We are also providing educational slides, Impella clinical dossiers and marketing tools, to hospitals, physicians and administrators, on how to expand their practice and improve outcomes, as well as highlight patient case studies.

為了展示批准的重要性，以下概述了我們的一些新計劃。我們現在能夠向介入和轉診心臟病專家提供直接教育和培訓，幫助他們了解如何識別和治療可能受益於受保護的 PCI 的患者。我們也向醫院、醫生和管理人員提供教育幻燈片、Impella 臨床檔案和行銷工具，介紹如何擴大他們的實踐和改善結果，並重點介紹病患案例研究。

In addition, Abiomed has launched a mobile learning lab, circling the United States. This 18-wheel double-wide trailer brings the TCT booth experience to the hospital door, drawing 50 customers to 100 customers each day, staffed by our clinical experts, teaching with our most advanced Impella simulators.

此外，Abiomed 還推出了一個環繞美國的行動學習實驗室。這款 18 輪雙寬拖車將 TCT 展位體驗帶到了醫院門口，每天吸引 50 到 100 名客戶，由我們的臨床專家組成，使用我們最先進的 Impella 模擬器進行教學。

And last, we have newly introduced a protected PCI website. It has both direct-to-patient and direct-to-physician portals, and can be found at www.protectedPCI.com.

最後，我們新推出了受保護的 PCI 網站。它有直接面向患者和直接面向醫生的入口網站，可以在 www.protectedPCI.com 上找到。

On other initiatives, our emergent business is also experiencing strong growth, and was up 42% in Q4. With regards to our pending FDA supplements, Impella RP rollout and the Japan regulatory process, all are proceeding as previously stated in prior earnings calls and Company communications.

在其他舉措上，我們的新興業務也經歷了強勁成長，第四季成長了 42%。關於我們懸而未決的 FDA 補充、Impella RP 推出和日本監管程序，所有這些都按照先前的財報電話會議和公司通訊中所述進行。

In summary, this quarter and fiscal year, Abiomed executed and achieved high-growth regulatory approvals and sustainable profitability, and is positioned to address a substantial clinical need, as Impella becomes the standard of care. We are financially sound and operationally prepared for many years of double-digit profitable growth in a $2 billion market opportunity. Abiomed would like to thank the FDA for their extensive review, and all our stakeholders for their support.

總而言之，本季和本財年，Abiomed 獲得了高成長的監管批准和可持續的獲利能力，並且隨著 Impella 成為護理標準，能夠滿足大量的臨床需求。我們財務狀況良好，營運上也做好了準備，能夠在價值 20 億美元的市場機會中實現多年兩位數的利潤成長。 Abiomed 感謝 FDA 的廣泛審查，以及我們所有利害關係人的支持。

I specifically want to thank all of our employees for their hard work and dedication, to our customers and patients. After 11 years as the Abiomed Chairman and CEO, there has never been another time with more excitement and confidence in our future. We know our success comes from our patients-first culture, and our commitment to meaningfully impacting the lives of our patients, and helping our physicians improve outcomes. I will now turn the call over to my CFO, Bob Bowen.

我特別要感謝我們所有員工的辛勤工作和對我們的客戶和患者的奉獻。在擔任 Abiomed 董事長兼執行長 11 年後，我們對未來感到前所未有的興奮和信心。我們知道我們的成功來自於我們以患者為先的文化，以及我們對有意義地影響患者的生活並幫助我們的醫生改善治療結果的承諾。我現在將把電話轉給我的財務長 Bob Bowen。

Thanks, Mike. Good morning, everyone. As noted in this mornings earnings release, fiscal fourth quarter revenue increased 34%, to a record $67.6 million, from $50.4 million in the prior year. On a constant currency basis, revenues increased 36%.

謝謝，麥克。大家，早安。正如今天早上發布的財報中所指出的，第四財季收入從上一年的 5,040 萬美元增長了 34%，達到創紀錄的 6,760 萬美元。以固定匯率計算，營收成長了 36%。

This is the second consecutive quarter where revenue growth exceeded 30%. And for the fourth fiscal quarter, this is particularly notable, given the more difficult comparison to the prior year. Worldwide total Impella product revenue of $63.4 million grew 38%, from $46.1 million in the prior year.

這是連續第二個季度營收成長超過30%。對於第四財季來說，這一點尤其值得注意，因為與前一年相比更加困難。 Impella 產品全球總營收為 6,340 萬美元，較前一年的 4,610 萬美元成長了 38%。

In the US, Impella revenue of $57.7 million grew 38%, from $41.8 million. This growth was due to Impella patient use, which was up 42%. The resulting Impella catheter reorder revenue, which totaled $51.7 million, was up 46%, and represented approximately 90% of total US Impella revenue.

在美國，Impella 的營收為 5,770 萬美元，較 4,180 萬美元成長了 38%。這一增長歸因於 Impella 患者使用量增加了 42%。由此產生的 Impella 導管再訂購收入總計 5,170 萬美元，成長了 46%，約占美國 Impella 總收入的 90%。

Outside the US, Impella revenue grew 30%, to $5.7 million. And was up 56% on a constant currency basis. Average Impella 2.5 and Impella CP combined unit inventory, at hospital sites, was 2.71 units, compared to 2.65 in the prior, sequential quarter, and 2.60 in the prior year.

在美國以外，Impella 營收成長了 30%，達到 570 萬美元。以固定匯率計算成長了 56%。醫院場所的平均 Impella 2.5 和 Impella CP 合併單位庫存為 2.71 單位，而上一季為 2.65 單位，去年同期為 2.60 單位。

We believe average site inventory levels of Impella 2.5 and Impella CP combined will trend towards three units per site, as sites increase utilization. Nonetheless, we expect sites will continue to carry the lowest reasonable Impella unit inventory level, and rely on Abiomed for restocking, based on patient usage, which is our preferred model.

我們認為，隨著站點利用率的提高，Impella 2.5 和 Impella CP 的平均站點庫存水準將趨向於每個站點 3 台。儘管如此，我們預計工廠將繼續保持最低合理的 Impella 單位庫存水平，並根據患者使用情況依靠 Abiomed 進行補貨，這是我們的首選模式。

With regard to the breakdown of patient utilization, 47% of patient use was in an elective or urgent setting, and this segment grew 53% from last year. 44% was in an emergent setting, and this segment grew 42% from last year and 9% was all other, which was, essentially, equal to the prior year.

關於患者使用情況的細分，47% 的患者使用是在選擇性或緊急情況下，該細分市場比去年增長了 53%。 44% 處於緊急環境中，該細分市場比去年增長了 42%，所有其他細分市場增長了 9%，基本上與前一年持平。

Gross margin for the quarter expanded to 84%, compared to 79.9% a year ago, up 4.1 points, due mostly to the benefit from higher-unit catheter revenue, higher production volume and a weaker euro. AIC console placements, during the quarter, were essentially unchanged at 130 this year, compared to 133 in the prior year.

本季的毛利率從去年同期的 79.9% 擴大到 84%，成長 4.1 個百分點，主要得益於單位導管收入增加、產量增加和歐元疲軟。本季 AIC 遊戲機的投放量基本保持不變，為 130 台，而去年為 133 台。

For the full year, gross margin rates of 82.7% were up three points from the prior year. For FY16, we are increasing our expected gross margin rate guidance to be in the range of 83% to 85%, from our previous expectation of 80% to 82%.

全年毛利率為82.7%，較前一年上升三個百分點。對於 2016 財年，我們將預期毛利率指引從先前的 80% 至 82% 上調至 83% 至 85%。

R&D expense for the fourth fiscal quarter, and full year, totaled $9.9 million and $36 million, respectively. And, was approximately 15% of revenue. We expect R&D expense to remain at approximately 15% of revenue for FY16. R&D expense includes research on next-generation products, product enhancements to the current product portfolios, such as the Opsens sensor, clinical studies including the US Impella registry, regulatory filing expenses and a full year of expense for ECP.

第四財季和全年的研發費用分別為 990 萬美元和 3,600 萬美元。並且，大約佔收入的15%。我們預計 2016 財年研發費用將維持在營收的 15% 左右。研發費用包括下一代產品的研究、目前產品組合的產品增強（例如 Opsens 感測器）、臨床研究（包括美國 Impella 註冊）、監管備案費用以及 ECP 的全年費用。

Not unlike FY15, we expect R&D expense, as a percentage of revenue, to be higher in the early part of the year, and trend downward toward the end of the year. SG&A expense for the fourth fiscal quarter, and full year, totaled $34.5 million and $125.7 million respectively. And, for the year, was approximately 55% of revenue.

與 2015 財年不同的是，我們預期研發費用佔營收的百分比在年初會較高，而到年底則呈現下降趨勢。第四財季和全年的 SG&A 費用分別為 3,450 萬美元和 1.257 億美元。並且，這一比例約為當年收入的 55%。

We are continuing to invest in our field personnel, training, customer support and marketing initiatives, particularly those that are incorporated into our launch of protected PCI. For FY16, we expect SG&A expense, as a percentage of revenue, to tick down a couple of points from FY15. And also, to be higher as a percentage of revenue, in the first half of the year, than in the second half.

我們將繼續投資於我們的現場人員、培訓、客戶支援和行銷計劃，特別是那些納入我們推出受保護 PCI 的計劃。對於 2016 財年，我們預期 SG&A 費用佔營收的百分比將比 2015 財年下降幾個百分點。而且，上半年佔收入的百分比高於下半年。

Operating profit for the fourth fiscal quarter of $12.4 million, or 18.3% of revenue, more than tripled from the prior year, reflecting a substantial leverage of our business model. GAAP net income for the quarter of $98.9 million, and for the year of $113.7 million, included an income tax benefit of $86.5 million, primarily due to the release of our valuation allowance on most of our deferred tax assets. This is a one-time accounting adjustment, with the offset recorded on the balance sheet as short- and long-term deferred tax assets, based on our determination that these deferred tax assets are realizable from sustained future profitability.

第四財季營業利潤為 1,240 萬美元，佔營收的 18.3%，比前一年成長了兩倍多，反映出我們業務模式的巨大槓桿作用。本季 GAAP 淨利潤為 9,890 萬美元，全年 1.137 億美元，其中包括 8,650 萬美元的所得稅收益，這主要是由於我們釋放了大部分遞延稅資產的估值準備金。這是一項一次性會計調整，根據我們確定這些遞延所得稅資產可以從持續的未來獲利能力中實現，在資產負債表上抵銷記錄為短期和長期遞延所得稅資產。

The deferred tax assets are primarily net operating loss carry-forwards in the US and Germany that we expect to utilize to offset future tax liabilities. Remember, these net operating losses were incurred over a period of many years, due to the high levels of investment needed to bring new medical device technologies to market. For future year modeling purposes, our estimated combined federal and state income tax rate, for accounting purposes, will approximate 40%.

遞延所得稅資產主要是美國和德國的淨營業虧損結轉，我們預期將用其來抵銷未來的稅務負債。請記住，這些淨營運虧損是在多年的時間內產生的，因為將新的醫療設備技術推向市場需要大量投資。出於未來年度建模的目的，出於會計目的，我們估計聯邦和州所得稅合併稅率將約為 40%。

Our balance sheet remains in excellent shape. And, we ended the quarter with cash, and short- and long-term marketable securities of $146 million. Notably, in the fourth fiscal quarter, cash provided by operating activities, less expenditures for planned property and equipment, totaled $15.2 million and for the year, totaled $38.1 million.

我們的資產負債表保持良好狀態。而且，本季結束時，我們擁有 1.46 億美元的現金以及短期和長期有價證券。值得注意的是，在第四財季，經營活動提供的現金減去計畫財產和設備的支出，總計為 1,520 萬美元，全年總計為 3,810 萬美元。

We expect to continue to generate strong cash flows in FY16, and expect to use approximately $15 million to $20 million to expand our facilities in both our Danvers, Mass an Aachen, Germany locations, to support additional manufacturing capacity, and growth in our operational support infrastructure. Our philosophy is to eliminate any risk of limitation in our supply chain, in support of our journey to become standard of care.

我們預計在2016 財年將繼續產生強勁的現金流，並預計將使用約1500 萬至2000 萬美元來擴建我們在馬薩諸塞州丹佛斯和德國亞琛的工廠，以支持額外的製造能力和運營支持的成長基礎設施。我們的理念是消除供應鏈中的任何限制風險，以支持我們成為護理標準的旅程。

Turning to guidance, as noted in our earnings release, we have increased the full year FY16 revenue guidance. And, the new range is now $285 million to $295 million, representing growth of 24% to 28% from the prior year. This new range compares to the range noted on our last conference call of $260 million to $270 million, which, at the time, represented an estimated increase of 15% to 21% from the prior year estimate.

至於指導，正如我們在財報中指出的，我們提高了 2016 財年全年收入指引。而且，新的範圍目前為 2.85 億至 2.95 億美元，較上年增長 24% 至 28%。與我們上次電話會議上指出的 2.6 億美元至 2.7 億美元的範圍相比，這一新範圍在當時比上一年的估計增加了 15% 至 21%。

Our guidance includes approximately $4 million to $6 million of revenue from the launch of Impella RP, as we plan to continue to govern the pace of the launch, maintain rigor in training and focus on optimal patient outcomes, as the best route to becoming standard of care. In addition, we have not yet Incorporated Impella revenue from Japan. And, we'll provide updates later in the year, as we get closer to approval.

我們的指導包括從 Impella RP 的推出中獲得約 400 萬至 600 萬美元的收入，因為我們計劃繼續控制推出的節奏，保持嚴格的培訓並專注於最佳的患者結果，作為成為標準的最佳途徑關心。此外，我們尚未納入 Impella 來自日本的收入。而且，當我們接近批准時，我們將在今年晚些時候提供更新。

Consistent with historical patterns, we expect to see higher revenue levels in the second half of the year than in the first half. With high levels of confidence in our guidance and we have a history of performance. I would also like to note that we expect top-tier medical device industry revenue growth for several years. And, we'll provide additional color at our investor meeting planned for later this year.

與歷史模式一致，我們預計下半年的收入水準將高於上半年。我們對我們的指導充滿信心，並且擁有良好的業績歷史。我還想指出的是，我們預計頂級醫療器材產業的收入將持續成長數年。而且，我們將在計劃於今年稍後舉行的投資者會議上提供更多資訊。

Also as noted in our earnings release, the Company is giving its fiscal year guidance of GAAP operating margin to be in the range of 12% to 16%.

另外，正如我們在財報中指出的，公司給出的 GAAP 營業利潤率財年指引為 12% 至 16%。

In summary, this past year was a record year for Abiomed, in terms of patients treated, financial performance and shareholder returns. It was also a validation of a new, high-risk patient population, and an inflection point along our journey to become the new standard of care. Operator, would you please now open the line for questions?

總而言之，過去的一年對 Abiomed 來說是創紀錄的一年，無論是在治療患者數量、財務表現或股東回報方面。這也是對新的高風險患者群體的驗證，也是我們成為新護理標準過程中的轉捩點。接線生，現在請您撥打電話提問好嗎？

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）

Danielle Antalffy, Leerink.

丹妮爾·安塔菲，萊林克。

Thanks so much, good morning guys. Thanks for taking a question and congrats on yet another awesome quarter. Mike, I was hoping you could give a little bit of color, obviously RP has now launched. How much did that contribute in the quarter? Any sort of level of clarity around the contribution of RP would be excellent.

非常感謝，大家早安。感謝您提出問題，並祝賀又一個精彩的季度。麥克，我希望你能給點顏色，顯然 RP 現在已經推出了。這對本季貢獻了多少？任何有關 RP 貢獻的清晰程度都是非常好的。

Sure, the contribution was very small, because of the snow storms we had in the beginning of the calendar year. We had to cancel the first three courses. We currently have nine sites that are ordering from a commercial perspective, and we have 20 sites that have received IRB approval.

當然，由於年初的暴風雪，貢獻很小。我們不得不取消前三門課程。目前，我們有 9 個站點正在從商業角度進行訂購，我們有 20 個站點已獲得 IRB 批准。

Okay, that's really helpful. Just to follow-up on that, will you guys breakout RP in the future or not?

好的，這真的很有幫助。順便問一下，你們以後會突破RP嗎？

We normally, Danielle, give the percent of revenues and patients for each product. And, I would expect that we would continue to do that. As Mike mentioned, we are just really getting started with the RP. There was some delays because of the weather, but we are very positive on how the launch is going to proceed. As we've indicated before, it'll be a controlled launch, focused on patient outcomes.

丹妮爾，我們通常會給出每種產品的收入和患者百分比。而且，我希望我們會繼續這樣做。正如 Mike 所提到的，我們才剛開始使用 RP。由於天氣原因出現了一些延誤，但我們對發射的進展非常樂觀。正如我們之前指出的，這將是一次受控的啟動，重點關注患者的治療結果。

As a reminder Danielle, in order to receive the RP, the sites have to come in-house for training, and that's the entire heart teams. Intervention cardiologists, the cardiac surgeon, the heart-failure cardiologist and the lead nurse. So, the snow storms affected the ability to do the in-house training. But, we're ramping it back up. And, we are still on schedule to what we had anticipated, which was to have 20 sites for the first half of the fiscal year.

提醒一下 Danielle，為了獲得 RP，這些站點必須在內部進行培訓，而這就是整個核心團隊。幹預心臟科醫生、心臟外科醫生、心臟衰竭心臟科醫生和首席護理師。因此，暴風雪影響了內部訓練的能力。但是，我們正在加大力度。而且，我們仍然按計劃實現我們的預期，即本財年上半年將擁有 20 個站點。

Got it, understood. Just wanted to follow-up on the commentary, on the way we're looking at the market opportunity now. Mike, does this change all the cadence of you bringing new centers online for the 2.5? Does it accelerate that? Or, should we still be thinking about this as 25-ish sites per quarter? Thanks so much.

明白了，明白了。只是想跟進評論，我們現在正在尋找市場機會。麥克，這是否會改變您為 2.5 引入新中心的所有節奏？它會加速這一過程嗎？或者，我們仍應將其視為每季 25 個左右的網站？非常感謝。

Thanks, Daniel. We currently have 968 sites with the Impella 2.5. It will not change the pace that we're going to be opening these sites. It's still going to be in the 20 to 25 range, per quarter. And, we continue to remain focused on going deeper and training more physicians at our existing sites.

謝謝，丹尼爾。目前，我們有 968 個站點配備了 Impella 2.5。它不會改變我們開放這些網站的步伐。每季仍將在 20 到 25 個範圍內。而且，我們繼續專注於在現有站點進行更深入的培訓並培訓更多的醫生。

Perfect, thank you so much for taking the questions.

完美，非常感謝您提出問題。

Thanks Daniel.

謝謝丹尼爾。

Chris Cooley, Stephens.

克里斯·庫利，史蒂芬斯。

Good morning and thank you for taking the questions. And, congratulations again on a record quarter. I wanted to see if we could maybe just go back, I know you mentioned that Japan was not in the guide for the upcoming year. But, could you walk us through, just in terms of your expectations there?

早上好，感謝您提出問題。並且，再次恭喜創紀錄的季度業績。我想看看我們是否可以回去，我知道你提到日本不在來年的指南中。但是，您能否就您的期望向我們介紹一下？

I believe it was mid-calendar year, this year, Ministry of Health and Welfare approval, with reimbursement around calendar year end. Could you update us on your thoughts there, as well as at Symphony, with something we haven't heard about in some time. Thanks so much.

我記得是今年年中，衛生福利部批准的，在年底左右報銷。您能否向我們介紹一下您對 Symphony 以及 Symphony 的最新想法，以及一些我們一段時間以來從未聽說過的事情。非常感謝。

Thank you for the question, Chris. Our timeline for Japan is the same as previously stated. Which means in the January to March timeframe, or our Q4. We will have a limited commercial release at selected sites. We expect the approval, obviously, in the third quarter of our fiscal year. And, the reimbursement to happen in that time, or at the beginning of our fourth quarter.

謝謝你的提問，克里斯。我們在日本的時間表與之前所述的相同。這意味著在一月到三月的時間範圍內，或是我們的第四季。我們將在選定的地點進行有限的商業發布。顯然，我們預計將在本財年第三季獲得批准。而且，報銷將在那時發生，或者在我們第四季初發生。

In regards to your question on Symphony, we have made some product enhancements. And, we'll be -- we've been doing certain research work on some of the changes. And, we will give further updates on our product development at the upcoming investor meeting, which will happen this summer.

關於您關於Symphony的問題，我們對產品進行了一些增強。而且，我們一直在對一些變化進行某些研究工作。而且，我們將在今年夏天即將舉行的投資者會議上提供有關產品開發的進一步更新。

Thank you.

謝謝。

Thanks Chris.

謝謝克里斯。

Raj Denhoy, Jefferies.

拉吉·丹霍伊，傑弗里斯。

Hi, good morning. I wonder if I could ask a bit about the evolving view of this inoperable population that you are finding out there, that simply weren't being offered PCI or surgery. Do you have a sense of how big that is? And, are certain centers discovering it quicker than others?

早安.我想知道我是否可以詢問您在那裡發現的無法手術人群的演變觀點，這些人群根本沒有接受 PCI 或手術。你知道它有多大嗎？而且，某些中心是否比其他中心更快發現它？

And maybe, just a sense of how that's developing. Because, it does seem from your comments, that that's really what is supporting this really reacceleration, or this new gear of growth you've found here. So, maybe some comments around that would be helpful.

也許，只是了解它是如何發展的。因為，從您的評論來看，這確實是支持這種真正的重新加速，或者您在這裡找到的這種新的增長齒輪的真正原因。所以，也許一些相關的評論會有所幫助。

The market for high-risk PCI has been defined, in the past, on the number patients that were receiving PCI with an intra-aortic balloon pump. Our historical research suggests that that number was around 25,000 patients to 30,000 patients per year, in the US. Now that Impella has entered the market, and has the ability to really provide stronger hemodynamic support, and the population of heart-failure patients continues to grow.

過去，高風險 PCI 市場是根據接受主動脈內球囊反搏器 PCI 的患者數量來定義的。我們的歷史研究表明，美國每年約有 25,000 至 30,000 名患者。現在Impella已經進入市場，並有能力真正提供更強的血流動力學支持，心臟衰竭患者群體持續成長。

What we're finding is patients that have class III and class IV, with ischemic disease or severe coronary artery disease, have the ability to have a treatment that can improve their injection fraction, and improve their heart classification by reducing it 58%. The numbers that we look, Raj, are based on populations around class III and class IV, which are approximately 1.6 million in class III and 300,000 class IV. And then, the other references that we see, relative to coronary artery disease, which is pretty significant. We've also followed a little bit of the model that the percutaneous valve company's have launched. And what that looks like is, patients that are now out in hospice care, or in clinics, that have limited options. And what they're doing now is screening them, to see if there's any ability to improve their quality of life.

我們發現，患有 III 級和 IV 級、患有缺血性疾病或嚴重冠狀動脈疾病的患者有能力接受治療，以改善他們的注射分數，並將其心臟分類降低 58%。 Raj，我們看到的數字是基於 III 級和 IV 級周圍的人口，其中 III 級大約有 160 萬，IV 級大約有 30 萬。然後，我們看到與冠狀動脈疾病相關的其他參考文獻，這非常重要。我們也遵循了一些經皮瓣膜公司推出的模型。看起來，現在接受臨終關懷或診所治療的患者的選擇有限。他們現在所做的就是對他們進行篩選，看看是否有能力改善他們的生活品質。

When you look at the percutaneous valve studies, it was definitely heart-team focused and, the average age was around 80 years old. And when you look at the Protect II study, the average age is 67. They're young, but they just have poor heart function and they can benefit from this PCI.

當你查看經皮瓣膜研究時，你會發現它絕對是心臟團隊的重點，平均年齡約為 80 歲。當你查看 Protect II 研究時，你會發現平均年齡是 67 歲。他們很年輕，但他們的心臟功能很差，他們可以從 PCI 中受益。

So as we've have moved forward, what we're really focused on is getting the appropriate use, the appropriate patient population and working as a heart team to identify that group, which is currently at class I recommendation for the AHA and Skye guidelines. And, that's why this population continues to grow because there is somewhat of a very large heart-failure population, in general. And in some cases, people refer to it as an epic population, because we're improving the outcomes of these patients, to live longer. However, many of them are suffering from congestive heart-failure and getting classified as class III and class IV.

因此，隨著我們不斷前進，我們真正關注的是獲得適當的用途、適當的患者群體，並作為心臟團隊工作來識別該群體，目前該群體屬於 AHA 和 Skye 指南的 I 級推薦。這就是該族群持續成長的原因，因為總體而言，心臟衰竭族群數量非常多。在某些情況下，人們稱之為史詩般的人群，因為我們正在改善這些患者的治療結果，以延長壽命。然而，他們中的許多人患有充血性心臟衰竭，被歸類為III級和IV級。

That's helpful, but maybe I can ask it in a slightly different way. You certainly -- one thing that's just been staggering the last couple of quarters is this new level of growth, in this mid 30% range. And, as you noted, this was even in the absence of really having the PMA in hand, and the ability to market Impella aggressively.

這很有幫助，但也許我可以用稍微不同的方式來問。當然，過去幾季令人震驚的一件事就是這種新的成長水平，在 30% 的中間範圍內。而且，正如您所指出的，即使沒有真正擁有 PMA，也沒有能力積極推銷 Impella，情況也是如此。

If you think about what's been behind this new level of growth, is it simply as you describe it, finding this new patient population? Is it an increase in the sales force? Is it just something that we can tangibly get our hands around, to really suggest that this is sustainable at this rate? I know your guidance is slightly below this, but still, this new level of performance from the Company.

如果您思考這種新的成長水平背後的原因，是否只是像您所描述的那樣，發現了新的患者群體？是銷售人員的增加嗎？這是否只是我們可以實際掌握的東西，以真正表明這種速度是可持續的？我知道您的指導略低於此，但公司的業績仍然達到了新的水平。

We stated in Q3 that we believe the growth was the tipping point, where we've achieved a critical mass in Impella, relative to 6 guidelines, over 200 publications and all the product awareness. In Q4, momentum did continue. And certainly, high-risk PCI accelerated at 53% growth.

我們在第三季表示，我們相信成長已經達到了臨界點，相對於 6 項指南、200 多篇出版物和所有產品認知度，我們在 Impella 中已經達到了臨界點。第四季度，勢頭確實持續。當然，高風險 PCI 以 53% 的速度加速成長。

And, we believe that does demonstrate that there is a large population. And, I think that the population has been there, but part of the process has been through education, through the guidelines, and now, through the regulatory acknowledgment from the FDA, that this is a feasible option for these patients.

而且，我們認為這確實表明存在大量人口。而且，我認為人們已經在那裡，但這個過程的一部分是透過教育、通過指南，現在，透過 FDA 的監管認可，這對這些患者來說是一個可行的選擇。

Great. That is helpful, thank you.

偉大的。這很有幫助，謝謝。

David Lewis, Morgan Stanley.

大衛路易斯，摩根士丹利。

Hi guys, thanks for taking the question. This is actually James in for David.

大家好，感謝您提問。這實際上是詹姆斯代替大衛。

Hi James.

嗨詹姆斯。

I was wondering, with a little bit of PMA experience under your belts, I was hoping you could comment a bit on the heart-team language required in the label, and how that process of approving patients with the heart team is playing out in the real world. How does the level of detail in those reviews compare to say, the process of some more familiar procedures like TAVR? And, over time, do you see that as being a gating factor at all, for utilization?

我想知道，憑藉您的一點 PMA 經驗，我希望您能對標籤中所需的心臟團隊語言發表一些評論，以及心臟團隊批准患者的過程是如何進行的真實世界。與 TAVR 等更熟悉的手術流程相比，這些審查的詳細程度如何？而且，隨著時間的推移，您是否認為這是利用的限制因素？

We received the PMA the last week of the quarter. So, I will basically comment on the end of the quarter. And then, we don't comment on current quarters. But James, the involvement of the heart team, which includes the cardiac surgeon, is not new. Our indication is consistent with the appropriate use criteria that was established by the medical community. And, that was documented in the 2011 ACC/ AHA guidelines, and that's for revascularization. We do not anticipate any change, based on our label. And, each hospital follows an appropriate use criteria, and/or has an algorithm to decide the treatment options.

我們在本季度的最後一周收到了 PMA。所以，我基本上會在季度末發表評論。然後，我們不對當前季度發表評論。但詹姆斯、包括心臟外科醫師在內的心臟團隊的參與並不新鮮。我們的適應症符合醫學界制定的適當使用標準。 2011 年 ACC/AHA 指引中記錄了這一點，即血管重建。根據我們的標籤，我們預計不會發生任何變化。並且，每家醫院都遵循適當的使用標準，和/或具有決定治療選項的演算法。

What the FDA approval does is, it further strengthens our ability to engage and educate the referring physicians, and patients, on the benefits of protective PCI. And, as we have been out surveying and getting ready for the PMA launch, it was very obvious that the heart-failure community, in general, really did not have any awareness to the clinical data and the studies that we provided to the FDA.

FDA 批准的作用是，它進一步增強了我們讓轉診醫生和患者了解保護性 PCI 益處並對其進行教育的能力。而且，當我們一直在為 PMA 的推出進行調查和準備時，很明顯，心臟衰竭社群總體上對我們向 FDA 提供的臨床數據和研究並沒有任何了解。

Okay thanks, that's helpful. Second, for Bob, with respect to the margin guidance, obviously, in the prior two quarters, you've been right at around a 20% operating margin. Your gross margin continues to get higher. So, there's some spending on SG&A. Anything, aside from supporting the launch in the US, that we need to be thinking about from a margin perspective, into 2016, in terms of, why you can't continue to achieve margin levels that you saw in the back half of 2015?

好的，謝謝，這很有幫助。其次，對鮑伯來說，就利潤率指引而言，顯然，在前兩個季度，營業利潤率一直維持在 20% 左右。您的毛利率持續提高。因此，SG&A 上有一些支出。除了支持在美國推出產品之外，我們還需要從利潤角度考慮到 2016 年的任何事情，為什麼你們不能繼續達到 2015 年下半年的利潤水平？

Well James, I think it's maintaining where we are with the R&D, for the areas that I called out in my script. And, in the SG&A area, it is basically just to continue in investment in the field organizations. And, we do have some funds set aside, also for the Japan launch.

好吧，詹姆斯，我認為對於我在劇本中提到的領域，我們正在保持研發的現狀。並且，在SG&A領域，基本上只是繼續對現場組織進行投資。而且，我們確實預留了一些資金，也用於在日本的推出。

Perfect, thank you.

完美，謝謝。

Ben Andrew, William Blair.

本安德魯，威廉布萊爾。

Good morning, thanks for taking the questions. Mike, maybe talk through how your conversations with hospitals are going, when it comes to discussing the reimbursement process, and how they are coding specifically for this. Because obviously, as the volumes go up, maybe you get a little bit more sensitivity to the cost of the device, and how hospitals are dealing with that? How it's fitting within the existing codes, what code they are using to bill under, please.

早上好，感謝您提出問題。麥克，也許可以談談您與醫院的對話進展如何，在討論報銷流程時，以及他們如何專門為此進行編碼。因為顯然，隨著數量的增加，您可能會對設備的成本更加敏感，以及醫院如何處理這個問題？它如何適應現有的代碼，他們使用什麼代碼來計費，請問。

Thanks for the question, Ben. The code we use is primarily DRG 216, and that is been in place since 2008, a when the device got 510(k) clearance. Relative to the way the discussions are going is, it's notable to look at what happens to our patients in our studies. When you track the outcomes from the procedure to 90 days, that matches the way hospitals are being rated today, from CMS, on their quality metrics.

謝謝你的提問，本。我們使用的代碼主要是 DRG 216，該代碼自 2008 年（設備獲得 510(k) 許可）起就已使用。相對於目前的討論方式，值得注意的是在我們的研究中觀察患者身上發生的情況。當您追蹤從手術到 90 天的結果時，這與 CMS 目前對醫院的品質指標進行評級的方式相符。

So specifically, all hospitals are being rated, from discharge to 90 days, on three criteria. One is heart failure, which is a subset; Protective PCI is a subset. One is AMI, which is emergency patients. And one is pneumonia, which we have no impact. So, two of the three key parameters for their metrics, Impella has the ability to impact. And specifically, what we do is, we reduce, with the Impella protective PCI, we reduce those out of hospital, adverse events.

具體來說，所有醫院都根據三個標準對從出院到 90 天的時間進行評估。一種是心臟衰竭，它是其中的一個子集；保護性 PCI 是一個子集。一是AMI，即急診患者。其中之一是肺炎，我們對此沒有影響。因此，Impella 指標的三個關鍵參數中的兩個有能力產生影響。具體來說，我們所做的是，透過 Impella 保護性 PCI，我們減少了院外不良事件。

On a hard basis overall, something called Mace, it's a 29% reduction. For the patients, you're looking at, really, a drastic improvement in the way they feel. That is the 58% reduction in heart failure. And that is something that is very important to CMS. Because, they're looking at the quality of life and the benefit of patients.

總體而言，在稱為 Mace 的硬基礎上，減少了 29%。對於患者來說，他們的感受確實得到了巨大的改善。也就是說，心臟衰竭的發生率降低了 58%。這對 CMS 來說非常重要。因為，他們關注的是病人的生活品質和利益。

And then, last is, there's a huge focus on hospitals for readmissions. And, the Impella data shows a 52% reduction in repeat procedures. So, it's a 52% reduction for that patient, that 70 year old, from coming back to the hospital to have a repeat procedure.

最後，人們非常關注醫院的再入院情況。而且，Impella 數據顯示重複手術次數減少了 52%。因此，對於這位 70 歲的患者來說，返回醫院重複手術的次數減少了 52%。

It was also important to note that, in the FDA press release on the approval, they also noted that the Impella had the ability to have fewer, later, adverse events, and gave an example as the need for repeat, high-risk PCI procedures. So, what we're looking at is, showing the benefits of better care. And, what those benefits mean in reducing the length of stay at the hospital, but most important, how the patient can improve their quality of life, and improve their heart function.

還需要注意的是，在 FDA 關於批准的新聞稿中，他們還指出 Impella 有能力減少後續的不良事件，並舉例說明需要重複、高風險 PCI 手術。因此，我們關注的是展示更好護理的好處。而且，這些好處對於減少住院時間意味著什麼，但最重要的是，患者如何改善他們的生活質量，並改善他們的心臟功能。

That's great. Obviously, the code pays at an attractive rate for the hospitals. Have you had any pushback from any of the regional payers? Or, others about the rate, or trying to use different codes, as opposed to, obviously, the hospital's would rather use a higher paying code?

那太棒了。顯然，該代碼支付的費用對醫院來說很有吸引力。您是否受到任何地區付款人的抵制？或者，其他關於費率的問題，或嘗試使用不同的代碼，而不是顯然，醫院寧願使用更高的付費代碼？

The CMS process is very thorough. And, they have a very experienced bullpen of physicians. And, we have communication with them on an ongoing basis. Now that we have an FDA approval that says we are the only safe and effective device for high-risk PCI, that should only strengthen and help us in our discussions with the regional payers. But, we have not had any changes to reimbursement from CMS, since 2008. And, we have an FDA approval now, for prophylactic use. And, we have class I recommendations for emergent use. So, we continue to work with them, but I believe this is why Impella is one of the most cost-effective devices in med tech. And, it's because we have hard information, hard data that shows these improvements in quality of life. And also, reduction of these adverse events, that are out to 90 days post-discharge.

CMS 流程非常徹底。而且，他們擁有經驗豐富的醫生牛棚。而且，我們與他們保持持續的溝通。現在我們已獲得 FDA 的批准，表明我們是唯一安全有效的高風險 PCI 設備，這只會加強和幫助我們與地區付款人的討論。但是，自 2008 年以來，我們對 CMS 的報銷沒有任何變化。而且，我們現在已獲得 FDA 批准用於預防性用途。而且，我們有緊急使用的 I 類建議。因此，我們繼續與他們合作，但我相信這就是為什麼 Impella 成為醫療技術領域最具成本效益的設備之一的原因。而且，這是因為我們有硬資訊、硬數據來顯示生活品質的這些改善。此外，還可以減少出院後 90 天內的這些不良事件。

Two more topics for me. If you think about the trajectory of balloon pump usage at some of your higher utilizing sites, even in the few months since you've had the new guidelines, and obviously the approval, what are you seeing? Does it go to zero? Does it get cut in half? Is it supplemental? What is the range of behaviors you are seeing from customers?

我還有兩個話題。如果您考慮氣球泵在一些利用率較高的場所的使用軌跡，即使在您制定新指南並顯然獲得批准後的幾個月內，您會看到什麼？它會歸零嗎？它會被切成兩半嗎？是補充的嗎？您從客戶看到的行為範圍有哪些？

Ben, at our most active sites, that are doing advanced work in hemodynamics, they no longer use a balloon pump for most of the patients, with two exceptions. One is, if there is a physician who has not gone through the learning curve, and they're not comfortable with the new technology. And, they might rely on the balloon pump because that's what they been using for 20 or 30 years.

Ben，在我們最活躍的站點，正在進行血流動力學方面的高級工作，他們不再為大多數患者使用球囊泵，但有兩個例外。一是，如果有一位醫生沒有完成學習曲線，而且他們對新科技感到不舒服。而且，他們可能會依賴氣球泵，因為他們已經使用氣球泵 20 或 30 年了。

The other is, patients that are looking for somewhat of a tune-up, before an open-heart surgery, the balloon pump can provide coronary enhancement. But it's not a hemodynamic device for that patient population. That's the trend that we see at our busiest sites.

另一個是，在心臟直視手術之前尋求某種程度調整的患者，球囊幫浦可以提供冠狀動脈增強功能。但它不是適合該患者族群的血液動力學裝置。這就是我們在最繁忙的網站上看到的趨勢。

Great. And then finally, on the manufacturing expansion that Bob mentioned before, the gross margin guidance was exceptional. Is there a window at some point over the next year or two, when we could see that dip, based upon that capacity coming online? Or, can we think of this as more of a smooth ramp, and not big chunks of capacity coming on the line, that would be underutilized? Thank you.

偉大的。最後，關於鮑伯之前提到的製造業擴張，毛利率指導非常出色。在未來一兩年的某個時間點，我們是否會看到基於上線容量的下降？或者，我們是否可以將其視為更多的平滑斜坡，而不是大量產能投入使用，從而未被充分利用？謝謝。

I think it's generally going to be a relatively smooth ramp. And, we'll add capacity. I mean, we are building out the capacity. The operators, actually, will be hired over a hard period of time. And so, I expect the ramp itself to be relatively smooth. We just want to be prepared for the upside that we see in the business.

我認為這通常會是一個相對平穩的斜坡。而且，我們將增加容量。我的意思是，我們正在增強能力。事實上，操作員的聘用將經歷一段艱難的時期。因此，我預計坡道本身會相對穩定。我們只是想為我們在業務中看到的好處做好準備。

Thank you very much.

非常感謝。

Brooks West, Piper Jaffray.

布魯克斯·韋斯特，派珀·賈弗雷。

Thank you for taking the questions. Bob, I was hoping you could help us with cadence a little bit. Obviously, you just got the high-risk PCI label at the end of March.

感謝您提出問題。鮑勃，我希望你能幫助我們調整節奏。顯然，您在三月底剛剛獲得了高風險 PCI 標籤。

You've got some easier comps in the first half. Can you just help us -- do you expect a bigger growth, year over year, in the first half of the year, or a nice ramp of growth? How should we think about the cadence throughout the year?

上半場你有一些更簡單的比賽。您能幫助我們嗎？您預計今年上半年同比會有更大的成長，還是會有一個不錯的成長？我們該如何思考全年的節奏？

Hi, Brooks. I think our expectation is that the cadence will be not unlike its been in prior years. We will see more growth in the second half than in the first half. As you know, the first and second quarters, for us, have always been more challenging than the third and the fourth.

嗨，布魯克斯。我認為我們的期望是節奏不會與前幾年不同。我們將看到下半年比上半年有更多的成長。如你所知，第一季和第二季對我們來說總是比第三季和第四季更具挑戰性。

We have this new label, and this new protective PCI launch, but this is also new territory for us. So, we are going to learn as we go. And, I think that's pretty much what our guidance incorporates.

我們有了這個新標籤，並推出了新的保護性 PCI，但這對我們來說也是一個新領域。因此，我們將邊走邊學。而且，我認為這幾乎就是我們的指南所包含的內容。

Okay. So, typical split of revenue. Quarterly, that's a way to look at it.

好的。因此，典型的所得分配。每季一次，這是一種看待問題的方式。

I would use a typical split, yes.

是的，我會使用典型的分割。

And then, going back to the operating margin question, earlier. I think, looking out a couple of years, investors see the ramp in revenue. They see the market opportunity. Your ability to hold even R&D at 15%, maybe 3 or 4 years out, is going to be challenging. Can you help us think a little bit about, what is the potential for operating margins, at the multi-year of double-digit growth rate, Mike, that you're talking about, maybe three or four years out from now?

然後，回到之前的營業利潤率問題。我認為，展望未來幾年，投資者會看到收入的成長。他們看到了市場機會。即使在 3 或 4 年後，您將研發費用維持在 15% 的能力也將是一項挑戰。麥克，您能否幫助我們思考一下，在您所說的多年兩位數成長率下，也許三、四年後，營業利潤率的潛力有多大？

I think, Brooks, right now, we think the right thing to do is to be investing in what we see as an extraordinary growth opportunity that comes along very few times in a lifetime. We have the first PMA approval for the Impella 2.5. We've got supplements to submit, and when those come along, those will be additional catalysts for the business.

我認為，布魯克斯，現在我們認為正確的做法是投資我們認為一生中很少出現的非凡成長機會。我們的 Impella 2.5 獲得了第一個 PMA 批准。我們需要提交補充資料，當這些補充資料出現時，它們將成為業務的額外催化劑。

So, our focus is really on driving the top line. And, that is how we are basically operating the business right now. On a longer-term basis, there's certainly no doubt in my mind -- and I think we have demonstrated this, by virtue of the fact that from time to time, our investment levels haven't kept pace with the growth of the business. That could happen again in FY16. But, there's no doubt in my mind that, in the long-term, we will have top-tier, industry-level operating margin rates.

因此，我們的重點實際上是提高營收。而且，這就是我們現在經營業務的基本方式。從長遠來看，我對此毫無疑問——而且我認為我們已經證明了這一點，因為我們的投資水平有時沒有跟上業務成長的步伐。這種情況可能會在 2016 財年再次發生。但是，毫無疑問，從長遠來看，我們將擁有頂級的行業級營運利潤率。

Just a couple follow-ups there. You mentioned the PMA supplements, is there any update on timing on submission there, or when you expect those to come through?

只有幾個後續行動。您提到了 PMA 補充資料，關於提交時間或您預計這些補充資料何時通過，是否有任何更新？

Brooks, this is Mike. Now that we have the PMA approved, we're working through all the specifics with the FDA for the remaining supplements, for the products and the indications. And, our current plan is to be prepared to submit the additional supplements by the end of September.

布魯克斯，這是麥克。現在我們已經獲得了 PMA 的批准，我們正在與 FDA 一起研究其餘補充劑、產品和適應症的所有細節。而且，我們目前的計劃是準備在九月底之前提交額外的補充資料。

Okay, perfect. And two more for me, if I could. Mike, there was a question earlier about new center adds. I've felt like you've been guiding us towards less of a focus on new center adds, at least in the US, and more of a focus on penetration. Can you talk about, what is the market that you are focusing on from an optimal number of centers, question one. As a follow-up to that, shouldn't your incremental SG&A spend, or at least S spend, come down, as you're not supporting as many centers to fund growth?

好的，完美。如果可以的話，再給我兩個。麥克，早些時候有一個關於新中鋒的問題。我覺得你一直在引導我們減少對新中心的關注，至少在美國，而更專注於滲透率。您能否談談，您從最佳數量的中心關注的市場是什麼，問題一。作為後續行動，您的增量 SG&A 支出（或至少是 S 支出）是否應該下降，因為您沒有支持那麼多中心來為成長提供資金？

Brooks, our main focus is, as you have stated it is, really to go deeper at the existing centers. Now that we have the PMA approval, we can really engage with the heart-failure community, the referring physicians and also direct to patients. And, we believe that our existing sites are trained and ready, and will provide the best quality and rigor, in the procedural success rate. That's really what we're focused on.

布魯克斯，正如您所說，我們的主要重點是真正深入現有中心。現在我們已經獲得了 PMA 的批准，我們可以真正與心臟衰竭社區、轉診醫生接觸，也可以直接接觸患者。而且，我們相信我們現有的站點已經過培訓和準備，並將在程序成功率方面提供最佳的品質和嚴格性。這確實是我們關注的重點。

And then, relative to the SG&A spend, Bob's already outlined that this year. And, we're really focused on getting the type of growth that maintains quality and rigor, in the outcomes and the training, because that's how you become the standard of care. We're not going to try to run too fast. And, we're not going to try to have any physicians starting to ramp the procedure, if we don't feel that they have the experience or expertise levels. So, we're going to do extensive training. And, we're going to be involved in opening up and supporting the physicians, to have better patient outcomes.

然後，相對於 SG&A 支出，鮑勃今年已經概述了這一點。而且，我們真正專注於在結果和培訓中獲得保持品質和嚴謹性的成長類型，因為這就是您成為護理標準的方式。我們不會嘗試跑得太快。而且，如果我們認為任何醫生不具備經驗或專業水平，我們就不會嘗試讓他們開始加強手術。因此，我們將進行廣泛的培訓。而且，我們將參與開放和支持醫生，以獲得更好的患者治療結果。

Great, thanks guys.

太好了，謝謝大家。

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）

Jayson Bedford, Raymond James.

傑森貝德福德，雷蒙德詹姆斯。

Good morning and congratulations on the progress. Just a few questions. On the supplements, for CP and 5.0, will the initial indication be the same as the one you received for the 2.5, or will it be different?

早上好，祝賀取得的進展。只是幾個問題。在 CP 和 5.0 的補充中，初始指示與您收到的 2.5 的指示相同還是不同？

Jayson, we will be submitting for the CP and the 5.0. We'll be submitting for additional indications. Some are larger, some are smaller. Things that have to do with myocarditis and postpartum cardiomyopathy.

Jayson，我們將提交 CP 和 5.0。我們將提交額外的指示。有些較大，有些較小。與心肌炎和產後心肌病變有關的事。

And, we do have several publications, and an FDA study, on the Impella 5.0, which tends to be more of a heart-failure patient, and more of a patient that has low cardiac output or shock. And then, just to remind all our investors, our US Registry on Impella has been a significant investment. And, we're going to continue to build that out. We have established separate data collection. We have our own executive committee. And we are -- in the end, we will create what is the largest database of high-risk patients that exists in the world.

而且，我們確實有一些關於 Impella 5.0 的出版物和一項 FDA 研究，該產品往往更多地針對心臟衰竭患者，並且更多地針對心輸出量低或休克的患者。然後，提醒我們所有的投資者，我們在 Impella 上的美國註冊中心是一項重大投資。而且，我們將繼續建造它。我們建立了單獨的數據收集。我們有自己的執行委員會。最終，我們將創建世界上最大的高風險患者資料庫。

All right, thanks. On the postapproval study, how long do think that it will take to finish enrollment, and when can we see data from the trial?

好的，謝謝。關於批准後研究，您認為需要多長時間才能完成入組，我們什麼時候可以看到試驗數據？

It's probably too soon to tell. We're still working through all of the specifics. And, we will give updates as we go, Jason. It's just a matter of how fast the enrollment, and the sites that are willing to go through and create that type of rigor, on something that they're supporting commercially.

現在說還太早。我們仍在研究所有細節。而且，我們會隨時提供最新情況，傑森。這只是一個註冊速度有多快的問題，以及願意在他們所支持的商業方面進行並創造這種嚴格性的網站的問題。

Okay. And then finally, maybe for Bob, can you break out the revenue contribution from CP, 2.5 and 5.0?

好的。最後，也許對鮑伯來說，你能列出 CP、2.5 和 5.0 的收入貢獻嗎？

Sure. The 2.5% this quarter was 26%.The CP was 65%. And, the 5.0 was 7%. And there is 1% leftover. It's some consult sales and a little bit of RP.

當然。本季的 2.5% 為 26%。CP 為 65%。而且，5.0 是 7%。還有1%的剩餘。這是一些諮詢銷售和一點點RP。

Got you, thanks.

明白了，謝謝。

Thank you. Jan Wald, The Benchmark Company.

謝謝。 Jan Wald，基準公司。

Good morning, everybody. Congratulations on the quarter. As you might imagine, most of my questions have been asked. But, one question I have is on the training and education program. I'm sure there is a lot of activity there. But, can you talk about the pace of the program? And, what you expect out of the program, in terms of the number of doctors educated, let's say, over the next fiscal year? Or, something like this, just to get a better understanding of what -- who and how many docs are going to be trained on the (inaudible) devices.

大家早安。恭喜本季。正如你可能想像的那樣，我的大部分問題都被問到了。但是，我有一個問題是關於培訓和教育計劃的。我確信那裡有很多活動。但是，您能談談該計劃的進度嗎？而且，您對該計劃的期望是什麼，就受教育的醫生數量而言，比方說，在下一個財政年度？或者，類似這樣的事情，只是為了更好地了解誰以及有多少文件將在（聽不清楚）設備上接受培訓。

Jan, thank you for the question. I think there's two pieces to the education for physicians. The first is ensuring that our users, that have the most experience, have all the tools that they need, and all the support that they need, to continue to treat the patient population that is growing.

簡，謝謝你的提問。我認為醫生的教育有兩個部分。首先是確保我們擁有最多經驗的使用者擁有他們需要的所有工具以及他們需要的所有支持，以繼續治療不斷增長的患者群體。

And, we also want to provide them tools that they can use with their hospitals, their administrators and their referring physicians, to create more awareness of the benefits of protective PCI.

而且，我們也希望為他們提供可與醫院、管理人員和轉診醫生一起使用的工具，以提高人們對保護性 PCI 益處的認識。

The second piece of our education is really, directly to the heart-failure community. And, this is a community that we haven't been able to engage in the past, because we did not have the regulatory approvals. And, to ensure that they understand that, you can have a high-risk PCI patient that is class III or class IV, and if they have ischemic disease, and you do extensive revascularization on this patient, you have real benefits and improvements in their quality of life, and improving their heart-failure status. And so, that's been documented in all of our European studies, and in the two FDA studies, Protect I and Protect II.

我們教育的第二部分其實是直接針對心臟衰竭社區的。而且，這是一個我們過去無法參與的社區，因為我們沒有獲得監管部門的批准。並且，為了確保他們了解這一點，您可以有一位III 級或IV 級高風險PCI 患者，如果他們患有缺血性疾病，並且您對這位患者進行了廣泛的血運重建，那麼您將在他們的病情中獲得真正的益處和改善。生活質量，並改善他們的心臟衰竭狀況。因此，我們所有的歐洲研究以及 FDA 的兩項研究（Protect I 和 Protect II）都記錄了這一點。

We're not looking to go out and create all new sites, with all new physicians. The product has been out under the 510(k) clearance since 2008. So really, it's about making sure our best users have all the tools they need to ensure their success. And then, to bring on the next level of adopters that have used Impella, but have not created a protected PCI practice, or who have not used it as extensively as some of their best users. And, that's really the focus right now, at our existing sites.

我們並不打算與所有新醫生一起出去創建所有新網站。該產品自 2008 年起就已獲得 510(k) 許可。因此，實際上，這是為了確保我們最好的用戶擁有確保他們成功所需的所有工具。然後，將已經使用 Impella 但尚未創建受保護的 PCI 實踐或未像一些最佳用戶那樣廣泛使用的採用者引入下一個級別。而且，這確實是我們現有站點目前的焦點。

Okay. And I guess my last question is, you talked about Symphony but, in terms of new product opportunities and where you are going to be going and how you are going to be investing in R&D over the next few years, could you talk a little bit about that strategy?

好的。我想我的最後一個問題是，您談到了 Symphony，但是，就新產品機會、您的發展方向以及未來幾年將如何投資研發而言，您能談談嗎？關於那個策略？

Jan, the amazing thing about our portfolio right now is that the Impella portfolio, from the left side to the right side, can potentially treat multiple types of patients. And, we're very focused on being the standard of care for percutaneous hemodynamic support, which is a large population of patients, as well as now, this protected PCI population.

Jan，目前我們的產品組合令人驚訝的是，Impella 產品組合，從左側到右側，可以治療多種類型的患者。而且，我們非常注重成為經皮血流動力學支持的護理標準，這是大量患者群體，以及現在受保護的 PCI 群體。

And if we do a good job here and provide a clinical solution for these patients. We're looking at $2 billion opportunity in the US, Germany, and Japan alone. So we're very focused on our existing product. However, we do have the worlds smallest heart pump. We do have extensive IP. So, you're going to see us continue to improve the existing products, to make them easier to put in. Better quality, as we expand the regulatory approvals on them. And then, later this summer at our investor day, we'll show a little but more of things we're working on. But again, we want to remain focused on this core opportunity, to become the standard of care.

如果我們在這裡做得很好並為這些患者提供臨床解決方案。我們正在尋找僅在美國、德國和日本就價值 20 億美元的機會。所以我們非常關注我們現有的產品。然而，我們確實擁有世界上最小的心臟泵。我們確實擁有廣泛的智慧財產權。因此，您將看到我們繼續改進現有產品，使它們更容易投入使用。隨著我們擴大對它們的監管審批，品質也會更好。然後，在今年夏天晚些時候的投資者日，我們將展示我們正在研究的一些但更多的東西。但同樣，我們希望繼續關注這一核心機會，成為護理標準。

Thank you very much and congratulations.

非常感謝並祝賀。

Thank you.

謝謝。

I am showing no further questions at this time. I'd like to turn the conference back to Mr. Mike Minogue for any further remarks.

我目前沒有提出任何進一步的問題。我想將會議轉回麥克·米洛先生，請他發表進一步的評論。

We just want to thank all supporters. And, if you have any follow-up questions, please feel free to call me direct. Have a great day.

我們只想感謝所有支持者。而且，如果您有任何後續問題，請隨時直接打電話給我。祝你有美好的一天。

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

女士們、先生們，感謝你們參加今天的會議。這確實結束了程序，你們都可以斷開連接。祝大家有個美好的一天。