美國安進 (AMGN) 2017 Q1 法說會逐字稿

Good afternoon. My name is Derek, and I will be your conference facilitator today for Amgen's First Quarter Financial Results Conference Call. (Operator Instructions)

午安.我叫德瑞克，今天我將擔任安進公司第一季財務業績電話會議的主持人。（操作說明）

I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

現在我謹向大家介紹投資人關係副總裁 Arvind Sood。蘇德先生，您可以開始了。

Thanks, Derek. Good afternoon, everybody. So first of all, thank you for taking the time to participate in our conference call today to review our operating performance for the first quarter of 2017. Before we begin, I would like to extend a warm welcome to those who are new in their coverage of Amgen, including of Umer Raffat of ISI Evercore and Carter Gould of UBS. Each of us very much look forward to working with you.

謝謝你，德里克。大家下午好。首先，感謝各位抽出時間參加我們今天的電話會議，共同回顧我們 2017 年第一季的經營業績。在正式開始之前，我謹向那些首次關注安進公司報道的人士表示熱烈歡迎，其中包括 ISI Evercore 的 Umer Raffat 和瑞銀集團的 Carter Gould。我們都非常期待與您合作。

We made a lot of progress during the quarter both in our commercial execution as well as our R&D efforts, so I'm anxious to get started.

本季我們在商業執行和研發方面都取得了很大進展，所以我很期待開始工作。

I would urge you to listen for specific themes, including volume-driven growth and operational expense management as you hear our senior leaders describe our performance.

我建議您在聽我們高階領導描述公司績效時，注意一些具體主題，例如銷售驅動成長和營運費用管理。

Our Chairman and CEO, Bob Bradway, will lead the call today with a brief report on how we are executing against our long-term strategy for growth. Following Bob, our CFO, David Meline, will review our financial results for the first quarter and our outlook for the remainder of 2017. Our Head of Global Commercial Operations, Tony Hooper, will then discuss our product performance during the quarter; followed by our Head of R&D, Sean Harper, who will provide a pipeline update. And I'll give you a heads-up right now that we have a lot to discuss on our R&D efforts.

我們的董事長兼執行長鮑勃·布拉德韋今天將主持電話會議，簡要匯報我們如何執行長期成長策略。在鮑伯之後，我們的財務長大衛梅林將回顧我們第一季的財務業績以及我們對 2017 年剩餘時間的展望。接下來，我們的全球商業營運主管托尼·胡珀將討論本季我們的產品表現；隨後，我們的研發主管肖恩·哈珀將提供產品線更新資訊。我現在就提前告訴你們，我們有很多關於研發工作的事情要討論。

As is customary for us, we will use slides for our presentation today, which have been posted on our website and a link was sent to you separately by e-mail.

按照慣例，我們今天將使用幻燈片進行演示，幻燈片已發佈在我們的網站上，並且透過電子郵件單獨向您發送了連結。

We plan on using non-GAAP financial measures in today's presentation to provide information which may be useful in understanding our ongoing business performance. However, these non-GAAP financial measures should be considered together with GAAP results, and reconciliations of these measures are available in the schedules accompanying today's press release, our Form 8-K and also on the Investor Relations section of our website.

我們計劃在今天的演示中使用非GAAP財務指標，以提供有助於了解我們持續業務表現的資訊。然而，這些非GAAP財務指標應與GAAP結果一併考慮，這些指標的調節表可在今天新聞稿隨附的附表、我們的8-K表格以及我們網站的投資者關係部分中找到。

Just a reminder that some of the statements made during the course of our presentation are forward-looking statements, and our 2016 10-K and subsequent filings identify factors that could cause our actual results to differ materially.

提醒各位，我們在演示過程中所作的一些陳述屬於前瞻性陳述，我們在 2016 年提交的 10-K 表格及後續文件中列出了可能導致我們實際結果與預期結果有重大差異的因素。

So with that, I would like to turn the call over to Bob. Bob?

那麼，接下來我將把電話交給鮑伯。鮑伯？

Okay. Thank you, Arvind, and thank you all for joining our call. We had an active first quarter at Amgen. And before talking about our financial results, I want to put the events of the first 90 days of the year in context because I think they underscore the reasons why we're confident about achieving our long-term objectives for growth. As you know, we're focused on 6 therapeutic categories, and during the quarter, we achieved important milestones in each of them.

好的。謝謝你，Arvind，也謝謝各位參加我們的電話會議。安進公司第一季業務十分活躍。在談論我們的財務表現之前，我想先回顧一下今年前 90 天發生的事情，因為我認為這些事情凸顯了我們有信心實現長期成長目標的原因。如您所知，我們專注於 6 個治療類別，並且在本季度中，我們在每個類別中都取得了重要的里程碑。

Core to our strategy is a commitment to differentiated innovation. We aim for products with a big effect size, in areas where the unmet need is high. That's what we feel we'll be required to succeed over the long term in this industry.

我們策略的核心是致力於差異化創新。我們的目標是開發效果顯著的產品，以滿足未被滿足的高需求領域的需求。我們認為，要想在這個行業取得長期的成功，就必須具備這樣的能力。

In our cardiovascular portfolio, we strongly believe Repatha represents one such product. As all of you know, cardiovascular disease poses by far the biggest health burden on society today. And our outcomes data demonstrated unequivocally that Repatha can play an important role in reducing that burden. And the data also showed, to my mind, that the rate of cardiovascular events, which approached 10% per year in the optimized statin arm of the trial, is still far too high without Repatha.

在我們的心血管產品組合中，我們堅信 Repatha 就是這樣一款產品。如大家所知，心血管疾病是當今社會面臨的最大健康負擔。我們的研究結果數據明確表明，Repatha 可以在減輕這種負擔方面發揮重要作用。在我看來，數據還表明，在試驗中優化的他汀類藥物組中，心血管事件的發生率接近每年 10%，如果沒有 Repatha，這個發生率仍然太高。

Against this backdrop, we expect Repatha to be an important product in the fight against cardiovascular disease and increasingly expect physicians, patients and other stakeholders to recognize that rejecting an innovative drug for high-risk patients, which demonstrated beyond 12 months a 35% reduction in the risk of heart attack, a 24% reduction in the rate of stroke and a 28% reduction in the rate of revascularizations, is simply inappropriate.

在此背景下，我們期望 Repatha 成為對抗心血管疾病的重要產品，並越來越希望醫生、患者和其他利益相關者認識到，拒絕一種創新藥物用於高風險患者是完全不合適的，該藥物在 12 個月以上已證明可將心臟病發作風險降低 35%，中風率降低 24%，血管重建率降低 28%。

The practice of medicine won't change overnight but it won't stall either. Not in the face of an innovative new therapy that can prevent hundreds of thousands of otherwise needless and tragic events.

醫學實踐不會在一夜之間改變，但也不會停滯不前。面對能夠預防數十萬起原本不必要的悲劇事件的創新療法，我們卻無法改變現狀。

In the U.S. alone, cardiovascular disease costs our society in excess of $600 billion a year, and without meaningful innovation like Repatha to change the trajectory of this disease, those costs will exceed $1.2 trillion by 2035.

光是在美國，心血管疾病每年就會造成社會超過 6,000 億美元的損失，如果沒有像 Repatha 一樣有意義的創新來改變這種疾病的發展軌跡，到 2035 年，這些損失將超過 1.2 兆美元。

We believe it's right to embrace innovation not only for patients but also for society. Economic study after study has shown that society benefits financially from adopting therapies like Repatha. Nonetheless, we recognize the access challenges of the day and that's why we have and will continue to offer innovative, value-based contracts to help build a bridge between the medical need and the affordability concerns for patients and payers.

我們認為擁抱創新不僅對病人有益，對社會也有益。一項又一項經濟研究表明，採用 Repatha 等療法可以為社會帶來經濟效益。儘管如此，我們也認識到當今醫療服務獲取方面的挑戰，因此我們一直並將繼續提供創新的、以價值為導向的合同，以幫助在患者和支付方的醫療需求和支付能力問題之間搭建橋樑。

In addition to novel biology, intellectual property is another source of differentiation for our innovation. And we were obviously gratified this quarter by the Delaware Court's support for our position on Repatha, and we now stand ready for the Appeals Court to hear the case in June.

除了新穎的生物學技術外，智慧財產權也是我們創新差異化的另一個來源。本季度，特拉華州法院對我們在 Repatha 問題上的立場表示支持，我們對此感到非常欣慰。現在，我們已做好準備，等待上訴法院在 6 月審理此案。

In oncology, there's no better standard for differentiated innovation than achieving an overall survival advantage for patients. In the first quarter, we achieved that; with both KYPROLIS and BLINCYTO. The BLINCYTO results are encouraging for patients with acute lymphoblastic leukemia, obviously, but more broadly, they're encouraging as validation for the whole approach of our immuno-oncology BiTE platform.

在腫瘤學領域，衡量差異化創新的最佳標準莫過於提高病患的整體存活率。第一季度，我們實現了這個目標；KYPROLIS 和 BLINCYTO 都取得了成功。BLINCYTO 研究結果對於急性淋巴性白血病患者來說無疑是令人鼓舞的，但更廣泛地說，這些結果也驗證了我們免疫腫瘤學 BiTE 平台的整體方法，令人鼓舞。

Perhaps because we're the only company with an advanced BiTE platform, this area is not as well understood in the investment community as other areas of immuno-oncology, but we're excited about the potential of our BiTEs and have several programs moving swiftly in our pipeline. We look forward to sharing data as they become available from these efforts.

或許是因為我們是唯一一家擁有先進 BiTE 平台的公司，投資界對這一領域的了解不如對免疫腫瘤學的其他領域那麼深入，但我們對 BiTE 的潛力感到興奮，並且我們的研發管線中有幾個項目正在快速推進。我們期待在這些研究工作中獲得數據後與大家分享。

The overall survival data for KYPROLIS -- achieved at an interim analysis in relapsed multiple myeloma patients -- are also very important and timely. Having established superiority versus Velcade, we expect this data will drive increased share for KYPROLIS, particularly in the second line, and will also be helpful for reimbursement considerations.

KYPROLIS 在復發性多發性骨髓瘤患者的中期分析中獲得的整體存活數據也非常重要且及時。鑑於 KYPROLIS 已證明優於 Velcade，我們預計該數據將推動 KYPROLIS 的市場份額增加，尤其是在二線治療領域，也有助於報銷方面的考慮。

Also in multiple myeloma this quarter, we achieved positive results for XGEVA. And subject to regulatory approvals, we look forward to being able to offer this therapy to multiple myeloma patients, many of whom are at risk of skeletal-related events such as those prevented by XGEVA.

本季度，我們在多發性骨髓瘤治療中也取得了XGEVA的正面成果。在獲得監管部門批准後，我們期待能夠為多發性骨髓瘤患者提供這種療法，其中許多患者面臨骨骼相關事件的風險，而 XGEVA 可以預防這些事件。

Bone health remains an area of high unmet medical need as still millions of women, at high risk for postmenopausal fractures remain untreated. Reflecting on the number of postmenopausal fractures, the World Health Organization called this a global epidemic.

骨骼健康仍然是一個醫療需求未被充分滿足的領域，因為仍有數百萬停經後骨折高風險女性未得到治療。鑑於停經後骨折的數量，世界衛生組織稱之為全球流行病。

Prolia's ongoing significant volume-driven growth, 21% in the quarter, attests to the value of differentiated innovation in this field. Already the leader in bone health, we expect EVENITY will strengthen our hand. While we await both further clinical data and regulatory reviews, Sean will describe the encouraging results that we received this quarter for the 3-year follow-up from the FRAME study.

Prolia 持續取得顯著的銷售成長，本季成長 21%，證明了差異化創新在該領域的價值。我們已是骨骼健康領域的領導者，相信 EVENITY 將進一步增強我們的優勢。在我們等待進一步的臨床數據和監管審查的同時，肖恩將介紹我們本季從 FRAME 研究的 3 年追蹤中獲得的令人鼓舞的結果。

While discussing our strategy of differentiated innovation, I also want to address our newest therapeutic area, which is, of course, neuroscience, where we are in the threshold of a novel, first-in-class therapy for migraine sufferers.

在討論我們差異化創新策略的同時，我也想談談我們最新的治療領域，當然就是神經科學，我們正處於為偏頭痛患者研發一種新型、首創療法的門檻上。

We had the opportunity to present our registration-enabling data at the American Academy of Neurology this week. And not surprisingly, experts in the field were excited about erenumab in an area where there's otherwise precious little to offer those suffering from episodic and chronic migraine.

本週我們有機會在美國神經病學會上展示了我們用於註冊的數據。不出所料，該領域的專家們對 erenumab 感到興奮，因為對於患有發作性偏頭痛和慢性偏頭痛的人來說，目前幾乎沒有其他有效的治療方法。

I've seen some headlines asking whether our expanded collaboration with Novartis signals a waning of our enthusiasm for this opportunity. The answer is: Absolutely not. We have high hopes for erenumab, and at the same time, we recognize this is a new therapeutic category for us and will likely be a competitive race. So we were very pleased that Novartis, already our collaborator in international markets, shared our enthusiasm for this first-in-class molecule in the U.S. and our determination to resource this product to win. With their decades of experience in neurology and a shared commitment to serve those suffering for migraine, we're excited about our expanded collaboration.

我看到一些新聞標題質疑，我們擴大與諾華的合作是否意味著我們對這機會的熱情有所減退。答案是：絕對不是。我們對erenumab寄予厚望，同時我們也意識到，這對我們來說是一個新的治療領域，而且很可能是一場競爭激烈的競賽。因此，我們非常高興地看到，諾華公司（我們已經在國際市場上合作）與我們一樣，對這款美國首創分子充滿熱情，並決心投入資源，使該產品取得成功。憑藉他們在神經病學領域數十年的經驗以及為偏頭痛患者服務的共同承諾，我們對擴大合作感到非常興奮。

When it comes to strategy, you've also heard us talk about life-cycle management, especially for our legacy franchises. The Neulasta Onpro launch is now widely seen as one of the most effective examples of this, with market shares now in excess of 50% in the U.S.

談到策略，您也聽我們談過生命週期管理，特別是對於我們的傳統特許經營品牌而言。Neulasta Onpro 的上市被廣泛認為是這方面最有效的例子之一，其在美國的市佔率已超過 50%。

In nephrology, we announced earlier this quarter an extension of our partnership with DaVita for EPOGEN. And of course, we also gained approval for Parsabiv in the U.S. As the established leader in nephrology therapeutics, we continue to look for ways to serve patients with kidney disease and expect this to remain an important franchise for us.

在腎臟病領域，我們在本季早些時候宣布延長與 DaVita 在 EPOGEN 的合作關係。當然，我們的 Parsabiv 也獲得了美國市場的批准。作為腎臟病治療領域的領導企業，我們將繼續尋找服務腎臟病患者的方法，並期望這將繼續成為我們重要的業務板塊。

As you know, an element of our strategy includes developing a portfolio of biosimilars, and I'm glad that we made that commitment as I think there will be a robust market for these products. While our portfolio of 10 biosimilars is progressing across the board, the highlight for the quarter was in inflammation, where we received EU approval to go along with our U.S. approval of AMGEVITA, our biosimilar to HUMIRA. The first steps in building out this business are to establish biosimilarity and gain registration, and obviously, we have done that now for an important molecule in the biggest markets. The next step is to navigate the IP landscape and the process for that is underway.

如您所知，我們策略的一個組成部分是開發一系列生物相似藥，我很高興我們做出了這項承諾，因為我認為這些產品將擁有強勁的市場。雖然我們的 10 種生物相似藥產品組合在各個方面都取得了進展，但本季度的亮點是炎症領域，我們獲得了歐盟的批准，此前我們的 HUMIRA 生物類似藥 AMGEVITA 也獲得了美國的批准。建立這項業務的第一步是確立生物相似性並獲得註冊，顯然，我們現在已經在最大的市場中為一種重要分子做到了這一點。下一步是了解智慧財產權格局，相關工作正在進行中。

Over the past couple of years, we've talked on these calls about our ongoing transformation efforts. We committed to a company-wide transformation -- real, meaningful change designed to make us more competitive, improve our operating margins and ensure that we would be in a strong position to return capital to our shareholders during this period of increasing competition for our legacy franchises and, while launching 9 innovative products, maintaining our investment in innovation, advancing a biosimilars portfolio and expanding our international presence from 50 to over 100 countries.

在過去的幾年裡，我們透過這些電話會議討論了我們正在進行的轉型工作。我們致力於公司範圍內的轉型——真正有意義的變革，旨在提高我們的競爭力，改善我們的營業利潤率，並確保我們能夠在傳統特許經營權競爭日益激烈的時期，為股東帶來豐厚的回報。同時，我們也將推出 9 款創新產品，繼續投資於創新，推動生物相似藥產品組合，並將我們的國際業務從 50 個國家擴展到 100 多個國家。

We have asked a lot of our staff and they have delivered. In our past results, you've seen our steady progress, and you see it once again this quarter; where our margins have grown, we delivered 9% earnings per share growth.

我們對員工提出了很高的要求，他們也出色地完成了任務。從我們過去的業績來看，你們已經看到了我們穩步前進的步伐，本季度你們再次看到了這一點；我們的利潤率有所增長，每股收益增長了 9%。

Looking forward, our orientation is long-term growth with volume-driven products, and we think we can deliver that across our focused therapeutic franchises. But we're also set on managing the business tightly to deliver in the short and medium term too. You should see this in our track record, and that's what you see in this quarter as well.

展望未來，我們的目標是透過銷售驅動型產品實現長期成長，我們相信我們能夠在我們專注的治療領域實現這一目標。但我們也決心嚴格管理業務，以確保在短期和中期內都能取得預期成果。你應該能從我們的過往業績中看到這一點，本季也同樣如此。

Our balance sheet and cash flows are strong, and we're looking for investment opportunities, albeit with the determination to add value for our shareholders, not just someone else's. Given valuations across many targets in the sector at the moment, that's challenging. But we'll remain patient and discriminating when it comes to M&A.

我們的資產負債表和現金流都很強勁，我們正在尋找投資機會，但我們決心為股東創造價值，而不僅僅是為其他人創造價值。鑑於目前該行業許多目標公司的估值都很高，這確實是一個挑戰。但在併購方面，我們將保持耐心和謹慎。

We've long advocated the need for corporate tax reform. If innovative U.S. companies are to remain competitive, we need a level tax playing field. We don't have one now but we're hopeful this administration will deliver that in 2017. Obviously, we think such change will improve our flexibility for capital allocation.

我們一直倡導企業稅制改革。如果美國創新企業想要保持競爭力，我們就需要一個公平的稅務環境。我們現在還沒有，但我們希望本屆政府能在 2017 年實現這一目標。顯然，我們認為這樣的改變將提高我們資本配置的彈性。

I'm taking a bit longer than usual on this call, but with all the events in the first quarter, I want to make sure to reiterate that we're investing in long-term opportunities, managing the business tightly and are poised to capitalize on investment opportunities which might arise.

這次電話會議我花的時間比平常長一些，但鑑於第一季發生的所有事件，我想再次強調，我們正在投資長期機遇，嚴格管理業務，並隨時準備好抓住可能出現的投資機會。

With that, let me once again thank our staff for their engagement with our mission, and then turn to David. Thank you.

在此，我再次感謝全體員工對我們使命的投入，然後請大衛發言。謝謝。

Okay. Thanks, Bob. We are pleased with our solid overall results and earnings growth again in the first quarter as our transformation efforts enabled progress in an environment of strong competition and portfolio transition. We also were encouraged by our 7% volume growth in Europe, reflecting the value of our innovative products in a market where we have experienced similar competition in portfolio transition for a number of years.

好的。謝謝你，鮑伯。我們對第一季穩健的整體業績和獲利成長感到滿意，因為我們的轉型努力在激烈的競爭和投資組合轉型環境中取得了進展。我們在歐洲的銷售量成長了 7%，這讓我們倍感鼓舞，也反映了我們創新產品在該市場的價值。多年來，我們一直在該市場經歷類似的競爭，並持續進行產品組合轉型。

Turning to the financial results on Page 6 of the slide deck. Worldwide revenues at $5.5 billion in the first quarter are flat year-over-year, excluding the impact of foreign exchange and are 1% lower on a reported basis, including FX.

接下來請看投影片第6頁的財務表現。第一季全球營收為 55 億美元，不計匯率影響，與去年同期持平；若計入匯率影響，則較去年同期下降 1%。

Worldwide product sales at $5.2 billion in the first quarter are flat year-over-year, excluding the impact of foreign exchange and are 1% lower on a reported basis including FX, as strong unit demand for our newer products was offset by declines in our mature brands.

第一季全球產品銷售額為 52 億美元，不計匯率影響，與去年同期持平；若計入匯率影響，則年減 1%，原因是新產品強勁的銷售需求被成熟品牌銷售的下滑所抵銷。

Other revenues at $265 million decreased $23 million versus the first quarter of 2016.

其他收入為 2.65 億美元，比 2016 年第一季減少了 2,300 萬美元。

Non-GAAP operating income at $3 billion, grew 5% from prior year. Non-GAAP operating margin improved by 3 points to 57.6% for the quarter, reflecting continued favorable expense impacts from our transformation initiatives across all operating expense categories and the expiry of the Enbrel residual royalty payment in Q4 of 2016.

非GAAP營業收入為30億美元，較上年成長5%。本季非GAAP營業利潤率提高了3個百分點，達到57.6%，這反映了我們轉型計劃在所有營運費用類別中持續帶來的有利費用影響，以及Enbrel剩餘特許權使用費在2016年第四季到期。

As in prior years, our operating margin is expected to be lower in the remaining quarters of the year, driven by the timing of expenses.

與往年一樣，受費用發生時間的影響，預計今年剩餘幾季的營業利潤率將有所下降。

On an overall full-year basis, we expect another year of strong operating margins, driven by tight operational expense management.

從全年整體來看，我們預計在嚴格的營運費用控制下，營運利潤率將持續保持強勁成長。

On a non-GAAP basis, cost of sales as a percent of product sales improved by 0.4 points to 13.1%, driven by manufacturing efficiencies, partially offset by product mix.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比提高了0.4個百分點，達到13.1%，這主要得益於生產效率的提高，但部分被產品組合所抵銷。

Research and development expenses at $748 million were down 13% year-over-year, driven by a first quarter 2016 payment related to a third-party collaboration agreement, lower spending required to support certain later-stage clinical programs and continued benefits from our transformation initiatives.

研發費用為 7.48 億美元，年減 13%，主要原因是 2016 年第一季度支付了與第三方合作協議相關的款項、支持某些後期臨床項目所需的支出減少以及我們轉型計劃帶來的持續效益。

Research and development as a percent of product sales at 14.4% is lower in Q1; consistent with the previous years. Going forward, research and development expense as a percent of product sales is expected to normalize around 2016 levels.

研發投入佔產品銷售額的比例為 14.4%，第一季有所下降，與往年持平。展望未來，研發費用佔產品銷售額的比例預計將恢復到 2016 年左右的正常水準。

SG&A expenses decreased 6% on a year-over-year basis due to expiry of the Enbrel residual royalty payment, partially offset by increased investments in new product launches.

由於 Enbrel 剩餘特許權使用費到期，銷售、一般及行政費用年減 6%，但部分被新產品上市投資增加所抵銷。

In aggregate, non-GAAP operating expenses decreased 7% year-over-year and remain on track to meet or exceed our 2018 commitment of $1.5 billion in transformation savings while investing to build the business globally, support new product launches and invest in the long-term pipeline for the business.

總體而言，非GAAP營運費用年減7%，並有望實現或超過我們2018年15億美元的轉型節約承諾，同時投資於在全球範圍內發展業務、支持新產品發布以及投資於業務的長期發展規劃。

Other income and expenses were a net $131 million expense in Q1. This is favorable by $13 million on a year-over-year basis, primarily driven by higher cash balances.

第一季其他收入和支出淨額為 1.31 億美元。與去年同期相比，這帶來了 1,300 萬美元的收益，主要得益於現金餘額的增加。

The non-GAAP tax rate was 18.5% for the quarter, a 0.4-point decrease versus the first quarter of 2016. This decrease reflects favorable changes in the geographic mix of earnings, partially offset by a smaller benefit from share-based compensation tax expenses compared to the first quarter of last year. As you may recall, this benefit is a result of the adoption of accounting standard update 2016-9, requiring these tax impacts to be recognized on the income statement versus the balance sheet.

本季非GAAP稅率為18.5%，比2016年第一季下降了0.4個百分點。這一下降反映了盈利地域組成方面的有利變化，但部分被與去年第一季相比，股權激勵稅收支出帶來的收益減少所抵消。您可能還記得，這項優惠是由於採用了 2016-9 號會計準則更新，要求在損益表而不是資產負債表中確認這些稅務影響。

The benefit of this adoption contributed approximately $0.06 to our non-GAAP earnings per share in this quarter compared to $0.09 in the first quarter of 2016.

與 2016 年第一季的 0.09 美元相比，此次採用帶來的收益使我們本季的非 GAAP 每股收益增加了約 0.06 美元。

Non-GAAP net income increased 6% and non-GAAP earnings per share increased 9% year-over-year for the first quarter, to $3.15 per share.

第一季非GAAP淨利年增6%，非GAAP每股盈餘較去年同期成長9%，達到每股3.15美元。

Turning next to cash flow and the balance sheet on Page 7. Free cash flow was $2.2 billion for the quarter, an increase of $400 million over last year. This increase was primarily driven by higher profitability as well as timing impacts of income tax payments to the IRS.

接下來請看第 7 頁的現金流量表和資產負債表。本季自由現金流為 22 億美元，比去年同期增加了 4 億美元。這一增長主要是由於盈利能力提高以及向美國國稅局繳納所得稅的時間影響所致。

We continue to provide significant cash returns to shareholders, consistent with our commitments, as we deployed $0.6 billion to repurchase 3.4 million shares at an average of $163 per share and are on track to achieve total share repurchase for this year in the range of $2.5 billion to $3.5 billion, as previously communicated.

我們持續履行承諾，為股東提供豐厚的現金回報。我們已投入 6 億美元以每股 163 美元的平均價格回購了 340 萬股股票，並有望實現今年股票回購總額在 25 億美元至 35 億美元之間的目標，正如之前所宣布的那樣。

Additionally, our first quarter dividend increased to $1.15 per share, an increase of 15% over last year. Cash and investments totaled $38.4 billion, an increase of approximately $3.7 billion from the first quarter of last year. This increase reflects continued solid net cash flow generation.

此外，我們第一季的股息增加到每股 1.15 美元，比去年增長了 15%。現金和投資總額為 384 億美元，比去年第一季增加了約 37 億美元。這一增長反映了淨現金流的持續穩健成長。

Our debt balance stands at $34.1 billion as of March 31, carrying a weighted average interest rate of 3.8% and an average maturity of 12 years.

截至 3 月 31 日，我們的債務餘額為 341 億美元，加權平均利率為 3.8%，平均期限為 12 年。

Turning to the outlook for the business for 2017 on Page 8. Overall, our 2017 revenue guidance remains unchanged at $22.3 billion to $23.1 billion. Our first quarter volume and price performance was in line with our plans as we experienced a solid contribution from our newer products while managing the impact of competition against the balance of the portfolio.

接下來請看第 8 頁對 2017 年業務前景的展望。整體而言，我們對 2017 年的營收預期保持不變，為 223 億至 231 億美元。第一季銷售和價格表現符合我們的計劃，這得益於新產品的穩健貢獻，同時我們也控制了競爭對產品組合其他部分的影響。

Revenue guidance also reflects the potential impact of the Repatha litigation and improving access for appropriate patients as a result of the positive Repatha cardiovascular outcomes data.

收入預期也反映了 Repatha 訴訟的潛在影響，以及由於 Repatha 心血管療效數據良好，為合適的患者改善了藥物途徑。

Finally, our guidance takes into account potential biosimilar competition against Neulasta commencing as soon as the fourth quarter of this year.

最後，我們的指導意見考慮到了最早從今年第四季開始可能出現的針對 Neulasta 的生物相似藥競爭。

With regard to our non-GAAP earnings per share guidance, we are raising the outlook to $12.00 to $12.60, reflecting our overall solid Q1 performance. In addition, our non-GAAP tax rate guidance remains unchanged at 18.5% to 19.5%, and we expect capital expenditures of approximately $700 million this year.

關於我們的非GAAP每股盈餘預期，我們將預期上調至12.00美元至12.60美元，以反映我們第一季的整體穩健業績。此外，我們的非GAAP稅率指導意見仍維持在18.5%至19.5%不變，我們預計今年的資本支出約為7億美元。

As previously stated, our 2017 guidance ranges are based on application of existing laws, including the Affordable Care Act and the current U.S. tax code, as well as current interpretation of the required notice period prior to commercial marketing of a biosimilar under the BPCIA. We will continue to update guidance going forward for changes in these factors and any other business updates.

如前所述，我們 2017 年的指導範圍是基於現行法律的應用，包括《平價醫療法案》和現行的美國稅法，以及根據《生物製品價格競爭與創新法案》(BPCIA) 對生物類似藥商業化上市前所需通知期的當前解釋。我們將根據這些因素的變化以及其他業務動態，持續更新指導意見。

Finally, consistent with our 2017 outlook, we remain confident we will meet or exceed the commitments provided for the 2014 to '18 period including double-digit non-GAAP EPS growth, non-GAAP operating margin improvement from 38% to 52% to 54%, $1.5 billion of transformation savings and return to shareholders of at least 60% of non-GAAP net income on average during the period.

最後，與我們對 2017 年的展望一致，我們仍然有信心實現或超過 2014 年至 2018 年期間所作出的承諾，包括兩位數的非 GAAP 每股收益增長、非 GAAP 營業利潤率從 38% 提高到 52% 再提高到 54%、15 億美元的股東節省以及在此期間至少 60% 的平均淨收入為 60% 的淨收入。

This concludes the financial update. I now turn the call over to Tony.

財務更新到此結束。現在我把電話交給東尼。

Thanks, David, and good afternoon, everyone. You'll find our product sales starting on Slide #10. Our business performance is shifting to a more volume-driven growth as we launch innovative products targeting large patient populations with unmet medical needs.

謝謝你，大衛，大家下午好。我們的產品銷售資訊從第 10 張投影片開始。隨著我們推出針對大量存在未滿足醫療需求的患者群體的創新產品，我們的業務表現正轉向以銷售驅動的成長模式。

Whilst our focus is on innovation, we've also executed effective life-cycle management strategies with some of our legacy brands which are facing potential new competition.

雖然我們專注於創新，但我們也對一些面臨潛在新競爭的傳統品牌實施了有效的生命週期管理策略。

Although U.S. revenues declined 1%, our ex-U. S. growth was 3%, excluding the impact of foreign exchange, fueled by a 7% volume growth.

儘管美國收入下降了 1%，但我們在美國以外的收入卻增加了 1%。不計匯率影響，美國經濟成長率為 3%，這主要得益於銷量成長 7%。

I'll now discuss our specific product performance and will structure my comments by therapeutic area.

接下來我將討論我們產品的具體性能，並按治療領域組織我的評論。

Let me begin with our bone health franchise. Prolia, a great example of one of our innovative products, has realized robust volume growth during the quarter with most of its 21% year-over-year sales growth driven by unit volume.

首先，我想介紹一下我們的骨骼健康特許經營項目。Prolia 是我們創新產品的絕佳例子，本季銷售量實現了強勁成長，其 21% 的年成長主要由銷售成長推動。

Prolia, with a strong value proposition, is uniquely positioned in postmenopausal osteoporosis as the leading branded product on the market. We will continue to invest in Prolia to reach a greater number of patients whilst reinforcing adherence for those already taking Prolia to ensure they continue to realize its benefits.

Prolia 具有強大的價值主張，在停經後骨質疏鬆症領域佔據獨特的市場地位，是市場上領先的品牌產品。我們將繼續投資Prolia，以惠及更多患者，同時加強已服用Prolia患者的依從性，以確保他們繼續獲得Prolia帶來的益處。

Overall, we expect Prolia will remain a significant growth driver as the approximately 850,000 U.S. patients on Prolia therapy only represent about 20% of patients presently being treated for postmenopausal osteoporosis.

總體而言，我們預期 Prolia 仍將是重要的成長動力，因為目前接受 Prolia 治療的美國患者約有 85 萬，僅佔停經後骨質疏鬆症患者總數的 20% 左右。

We also look forward to expanding our bone health franchise with romosozumab, our innovative bone-building molecule, which we now have a trade name, EVENITY. In conjunction with our partners at UCB, we are preparing for a U.S. launch in advance of the July 19 PDUFA date.

我們也期待透過 romosozumab（我們創新的骨骼建構分子，現在我們有了商品名 EVENITY）來擴展我們的骨骼健康產品線。我們正與 UCB 的合作夥伴一起，為 7 月 19 日 PDUFA 日期之前在美國上市做準備。

As Bob pointed out, having the ability to co-position EVENITY and Prolia sequentially will improve our ability to better treat this large patient population. With thousands of high-risk postmenopausal osteoporosis patients, such as those who have fractured, we have a proven therapeutic strategy with EVENITY to first build strong, new bone in patients with 12 months of treatment, followed by Prolia for proven continued fracture risk reduction.

正如鮑勃所指出的那樣，能夠依次聯合使用 EVENITY 和 Prolia 將提高我們更好地治療這個龐大患者群體的能力。對於成千上萬的高風險停經後骨質疏鬆症患者（例如發生過骨折的患者），我們採用 EVENITY 進行治療，這是一種行之有效的治療策略，首先透過 12 個月的治療在患者體內構建強壯的新骨，然後使用 Prolia 來持續降低骨折風險。

Oncology is another area that is benefiting from volume growth with our recently launched products, and let me start with KYPROLIS. KYPROLIS realized 23% year-on-year growth during the quarter, and most of this growth was volume-driven, including our international markets.

腫瘤學是另一個受益於我們近期推出的產品銷售成長的領域，讓我先從 KYPROLIS 開始說起。KYPROLIS 本季實現了 23% 的同比增長，其中大部分增長是由銷量推動的，包括我們的國際市場。

As you know, KYPROLIS was indicated in the U.S. for second and third-line multiple myeloma. In second line, triplet regimens are used in approximately 1/3 of patients, and despite new entrants, we've been able to achieve about 50% market share for new patient starts in this segment.

如您所知，KYPROLIS 在美國被批准用於二線和三線多發性骨髓瘤治療。在二線治療中，大約有 1/3 的患者使用三重療法，儘管有新的競爭者，但我們在該細分市場的新患者起始治療中仍獲得了約 50% 的市場份額。

The other 2/3 of second-line patients are treated with doublet regimens. And recent data from our ENDEAVOR study demonstrated that KYPROLIS plus dexamethasone improved overall survival by 21% or nearly 8 months when compared to Velcade plus dexamethasone.

其餘 2/3 的二線患者採用雙藥方案治療。我們 ENDEAVOR 研究的最新數據顯示，與 Velcade 加地塞米松相比，KYPROLIS 加地塞米松可將總存活期提高 21% 或近 8 個月。

Improving overall survival is the gold standard measurement when treating cancer. This data clearly establishes KYPROLIS as the proteasome inhibitor of choice and will be a compelling differentiator in our strategy to displace Velcade in this setting.

提高癌症患者的整體存活率是衡量癌症治療效果的黃金標準。這些數據清楚地表明 KYPROLIS 是首選的蛋白酶體抑制劑，並將成為我們在此領域取代 Velcade 的策略中具有說服力的差異化因素。

KYPROLIS is well accepted in large academic centers that treat high numbers of multiple myeloma patients, and we are now focusing on extending KYPROLIS' reach into the community oncology practices.

KYPROLIS 在治療大量多發性骨髓瘤患者的大型學術中心廣受歡迎，我們現在正致力於將 KYPROLIS 推廣到社區腫瘤診所。

Despite the introduction of new competing products in the U.S., we've also regained share in new third-line patients over the last few quarters. We expect proteasome inhibition to be foundational therapy in multiple myeloma for many years to come and are focused on growing in second and third lines of therapy with plans to expand KYPROLIS' use in newly diagnosed patients.

儘管美國推出了新的競爭產品，但在過去幾個季度裡，我們也重新獲得了三線新患者的市場份額。我們預計蛋白酶體抑制劑將在未來多年內成為多發性骨髓瘤的基礎療法，並專注於發展二線和三線療法，計劃擴大 KYPROLIS 在新診斷患者中的應用。

Outside the U.S., we continue to enter into new markets and secure reimbursement with the benefit of the new KYPROLIS overall survival data.

在美國以外，我們繼續進入新市場，並憑藉新的 KYPROLIS 整體生存數據獲得報銷。

XGEVA grew 6% year-over-year, mostly due to volume as we continue to emphasize its clinical benefits. We look forward to having the positive multiple myeloma study data added to our label. This will expand the patient population eligible for XGEVA treatment.

XGEVA 年成長 6%，主要原因是銷售成長，因為我們繼續強調其臨床優勢。我們期待將積極的多發性骨髓瘤研究數據添加到我們的標籤中。這將擴大符合 XGEVA 治療條件的患者群體。

Both Nplate and Vectibix saw another good quarter with volume growth of 9% and 6%, respectively.

Nplate 和 Vectibix 的季度業績均表現良好，銷量分別成長了 9% 和 6%。

Neulasta sales increased 2% year-over-year as we continue to see a small decline in the use of myelosuppressive chemotherapeutic agents.

由於骨髓抑制性化療藥物的使用量持續小幅下降，Neulasta 的銷售額年增了 2%。

The first quarter also benefited from accounting estimate changes due to lower Onpro returns, underscoring that Onpro delivery is working better than initially assumed. We continue to drive increasing adoption and Onpro now represents over 50% share of all Neulasta purchases. This has been a great example of a very successful life-cycle management strategy. And as David explained earlier, we expect minimal impact in 2017 from potential long-acting biosimilar competition.

第一季也受惠於 Onpro 退貨率下降導致的會計估計變化，這凸顯了 Onpro 的交付效果比最初預期的要好。我們持續推動產品普及，Onpro 目前已佔 Neulasta 所有採購份額的 50% 以上。這是一個非常成功的生命週期管理策略的絕佳範例。正如大衛之前解釋的那樣，我們預計2017年潛在的長效生物相似藥競爭的影響微乎其微。

I'd also note that the first quarter has historically benefited from heavier purchasing by certain end customers, and we estimate this benefit in quarter 1 to be about $50 million, which we expect to reverse in quarter 2.

我還想指出，第一季歷來受益於某些終端客戶更大的採購量，我們估計第一季的這一收益約為 5000 萬美元，我們預計第二季將出現逆轉。

For NEUPOGEN, the impact of competition was in line with prior performance. We exited the quarter retaining 46% share of the short-acting market in the U.S. We expect these competitive dynamics to continue over the course of 2017.

對紐寶健來說，競爭的影響與先前的表現一致。本季末，我們在美國短效市場保持了 46% 的份額。我們預計這種競爭格局將在 2017 年持續下去。

Moving now to Enbrel. I would start by emphasizing that we see no trend break versus 2016, and I will go through Enbrel carefully and in some detail because I don't want you to misinterpret long-term dynamics based on some quarter 1 peculiarities.

接下來是恩利（Enbrel）。首先我想強調的是，我們並未看到與 2016 年相比出現任何趨勢性突破，我會仔細、詳細地分析 Enbrel，因為我不想讓你們根據第一季的一些特殊情況誤解長期動態。

Before getting into quarterly performance, I'd like to highlight that we utilize IMS prescription data to analyze the business. Like many of you, we noticed a slowdown in the first quarter IMS scrips. Those has implications for our views on segment demand and end-user inventory levels. We've been in close contact with IMS, and they agree that the first quarter prescription data appears soft in several specialty product categories, including rheumatology and dermatology.

在深入探討季度業績之前，我想強調一下，我們利用 IMS 處方資料來分析業務。和你們中的許多人一樣，我們也注意到第一季IMS股票交易放緩。這些都會影響我們對細分市場需求和終端用戶庫存水準的看法。我們與IMS保持著密切聯繫，他們也認為第一季的處方數據在幾個專科產品類別中表現疲軟，包括風濕病學和皮膚病學。

As a matter of fact, on a year-over-year basis, unit growth in rheumatology appeared to slow from 9% in the first quarter of 2016 to 2% in this quarter. And from 25% to 9% in the dermatology segment for the same period.

事實上，從年比來看，風濕病學的單位成長率似乎從 2016 年第一季的 9% 放緩至本季的 2%。同期，皮膚科領域的比例從 25% 降至 9%。

IMS attributed the softness to a combination of several factors, including the number of shipping days in the fourth quarter 2016 versus the first quarter 2017; the impact of patient out-of-pocket costs including deductibles; and the Part D donut hole for the start of a new year, as well as the potential increasing use of 90-day prescriptions. This is also consistent with our view of the market.

IMS 將疲軟歸因於多種因素的綜合作用，包括 2016 年第四季度與 2017 年第一季相比的運輸天數；患者自付費用（包括免賠額）的影響；以及新年伊始的 D 部分自付額缺口，以及 90 天處方藥使用量可能增加。這也與我們對市場的看法一致。

We noted our expectations that the 2016 trends will continue into 2017. On a quarter-over-quarter basis, our share declined 1 percentage point to 32% in rheumatology and declined 2 percentage points in dermatology to 15%; in line with 2016 share trends.

我們預計 2016 年的趨勢將延續到 2017 年。與上一季相比，我們在風濕病領域的市佔率下降了 1 個百分點至 32%，在皮膚病領域的市佔率下降了 2 個百分點至 15%；這與 2016 年的市佔率趨勢一致。

As for the end-user inventory, we previously said that we expected quarter 1 reductions due to the quarter 4 2016 $150 million excess inventory.

至於終端用戶庫存，我們之前說過，由於 2016 年第四季 1.5 億美元的庫存過剩，我們預計第一季庫存將減少。

Based on the IMS data, we calculated an approximate $30 million reduction in inventory levels for this quarter. And therefore, we expect the remainder to be used up during the course of the year.

根據IMS數據，我們計算出本季庫存水準將減少約3,000萬美元。因此，我們預計剩餘部分將在年內用完。

Obviously, the accuracy of the IMS data has implication for our understanding of both unit demand dynamics and end-user inventory. Consistent with our previous guidance, net selling price had a minimal impact on year-over-year sales growth during quarter 1.

顯然，IMS 資料的準確性對我們理解單位需求動態和最終用戶庫存都有影響。與先前的預期一致，淨售價對第一季同比銷售成長的影響微乎其微。

On a quarter-on-quarter basis, we have seen increased commercial patient co-pay assistance impacting net selling price, which is likely a function of higher patient out-of-pocket costs. This impact typically tapers off over the remainder of the year, and our view on net selling price in 2017 is unchanged.

從季度來看，我們看到商業患者共同支付援助的增加影響了淨售價，這可能是由於患者自付費用增加所致。這種影響通常會在今年剩餘的時間逐漸減弱，我們對 2017 年淨售價的看法保持不變。

We are optimistic about our rebound in both Enbrel and Enbrel segment growth in future quarters as IMS prescription data from the more recent weeks shows improvement versus at the beginning of the year in both rheumatology and dermatology.

我們對未來幾季 Enbrel 和 Enbrel 業務部門的成長都持樂觀態度，因為最近幾週的 IMS 處方數據顯示，風濕病和皮膚病領域的情況都比年初有所改善。

So in summary, the quarter 1 results likely reflect a temporary marketplace issue, and we believe the long-term dynamics are intact and in line with our prior expectations. There remains a substantial number of patients for which Enbrel is the best treatment option, given its competitive efficacy and long-term safety profile. We will continue to invest in Enbrel to enhance its value, to bring to patients and providers. Given its long-term period of patent protection, Enbrel will continue to be a significant cash flow generator for Amgen for many years to come.

綜上所述，第一季的業績可能反映了暫時的市場問題，我們認為長期發展趨勢依然穩固，符合我們先前的預期。鑑於恩利具有良好的療效和長期安全性，對於相當多的患者而言，恩利仍然是最佳治療選擇。我們將繼續投資恩利，以提升其價值，造福病患和醫療服務提供者。鑑於其長期的專利保護期，恩利在未來許多年仍將是安進公司重要的現金流來源。

Turning now to our nephrology products, beginning with Aranesp. On a worldwide basis, Aranesp declined 4% year-over-year. In the U.S., it increased by 7% including the conversion from EPOGEN at numerous independent and midsize dialysis centers. This conversion was substantially completed by quarter 3 of 2016, with Aranesp now representing over 85% of the ESA usage.

現在讓我們來看看我們的腎臟病產品，首先是 Aranesp。從全球範圍來看，Aranesp 年減了 4%。在美國，這一數字成長了 7%，其中包括許多獨立和中型透析中心從 EPOGEN 轉換而來。到 2016 年第三季度，此轉換已基本完成，Aranesp 目前佔 ESA 使用量的 85% 以上。

Performance outside the U.S. was negatively impacted by foreign exchange as well as the timing of tenders in certain markets.

美國以外地區的業績受到外匯波動以及某些市場投標時間表的負面影響。

Now to EPOGEN. As previously disclosed, we recently renegotiated our supply agreement with DaVita. DaVita represents about 1/3 of the U.S. dialysis market and they will continue to predominantly purchase EPOGEN through 2022. In exchange for longer supply certainty, we made concessions on net selling prices, which impacted the quarter-on-quarter results.

接下來是促黃體生成素。正如之前披露的那樣，我們最近與 DaVita 重新談判了供應協議。DaVita 佔據了美國透析市場約 1/3 的份額，並且到 2022 年，他們將繼續主要採購 EPOGEN。為了換取更長時間的供應確定性，我們在淨售價上做出了讓步，這影響了季度環比業績。

Also, as David mentioned, we do not expect a material impact to our ESA business in 2017 from a short-acting biosimilar competitor.

此外，正如大衛所提到的，我們預期2017年短效生物相似藥競爭對手不會對我們的ESA業務產生實質影響。

Sensipar increased 15% year-over-year, driven by a combination of net selling price and volume growth. Parsabiv, our innovative new calcimimetic delivered intravenously, is now approved in both the U.S. and Europe, and we are working with CMS to secure a reimbursement mechanism in the U.S.

受淨售價和銷量成長的雙重推動，Sensipar 年成長 15%。Parsabiv 是我們創新研發的新型靜脈注射擬鈣劑，目前已在美國和歐洲獲得批准，我們正在與美國醫療保險和醫療補助服務中心 (CMS) 合作，以確保在美國獲得報銷機制。

Let me now turn to our cardiovascular franchise and Repatha. Let me first address the quarter-on-quarter growth, which might look a little strange. Quarter 4 2016 was slightly inflated due to the booking of a Middle East tender, which was not repeated in quarter 1 this year.

現在讓我來談談我們的心血管產品線和瑞百阿（Repatha）。首先讓我談談季度環比成長情況，這看起來可能有點奇怪。2016 年第四季由於承接了一項中東招標項目，導致業績略有上升，而今年第一季並未再次承接該項目。

With closer examination of the data, you'll see that we recorded positive volume growth in the U.S. of 14% and 28% in Europe. In the U.S., we achieved segment share of 64% in quarter 1 for new-to-brand patients and briefly touched on 70% as we exited the quarter.

仔細查看數據，你會發現我們在美國實現了 14% 的銷售成長，在歐洲實現了 28% 的銷售成長。在美國，我們在第一季的新品牌患者市佔率達到了 64%，並在季度末短暫達到了 70%。

In Europe, we exited 2016 with 56% segment share. Our U.S. formulary coverage has greatly improved over last year, especially Medicare Part D, where we have almost tripled the number of lives covered.

2016年底，我們在歐洲的市佔率為56%。我們的美國藥品目錄涵蓋範圍比去年有了很大的改善，尤其是聯邦醫療保險D部分，我們涵蓋的人數幾乎增加了兩倍。

Results of the Repatha cardiovascular outcome study that were presented at the American College of Cardiology last month, are clearly a game changer for cardiovascular patients; showing significant reductions in MIs and strokes.

上個月在美國心臟學會上發表的 Repatha 心血管結局研究結果，顯然改變了心血管疾病患者的治療格局；該研究顯示，心肌梗塞和中風的發生率顯著降低。

We also shared our analysis on the economic value of Repatha at the ACC. This calculation used standard peer-reviewed methodology using real-world event rates and imputed mortality benefit from the meta-analysis of previous studies with CTTC relationship, and concluded that prices in the market today are well within the value-based price range. Naturally, this calculation is based on average net selling price and not the list price.

我們也向 ACC 分享了我們對 Repatha 經濟價值的分析。此計算採用標準同儕審查方法，利用真實世界的事件發生率和從先前與 CTTC 關係的研究的薈萃分析中推斷出的死亡率獲益，並得出結論：目前市場上的價格完全在基於價值的價格範圍內。當然，這種計算是基於平均淨售價，而不是標價。

Since the ACC, we've been engaging with payers in the U.S. and across the world on Repatha's clinical data and economic value. We are in active discussions with all of the large U.S. PBMs and payers, and they recognize the importance of Repatha's outcome data to patients. We are focused on reducing barriers and improving processes to make it easier for a physician to prescribe Repatha and for patients to get access to this important therapy. We expect payers will start changing utilization management criteria and processes over the coming months.

自 ACC 會議以來，我們一直在與美國和世界各地的支付方就 Repatha 的臨床數據和經濟價值進行溝通。我們正在與所有美國大型藥品福利管理機構和支付方積極進行討論，他們也認識到 Repatha 的結果數據對患者的重要性。我們致力於減少障礙、改善流程，讓醫師更容易開立 Repatha 處方，也讓病人更容易獲得這種重要的治療。我們預計，未來幾個月內，支付方將開始改變醫療資源利用管理標準和流程。

Several independent groups have studied the access situation and have concluded that current access barriers are inappropriate and potentially harmful to patients. As pointed out in the recent publication by the Partnership for Health Analytic Research, or PHAR, it started with the irresponsible prediction of healthcare cost prior to FDA approval of the PCSK9 inhibitor class. These overestimates resulted in onerous restrictions and lack of patient access from the beginning.

多個獨立團體對就醫情況進行了研究，並得出結論：目前的就醫障礙是不恰當的，並且可能對患者有害。正如健康分析研究夥伴關係（PHAR）最近發表的出版物中所指出的那樣，這一切始於在 FDA 批准 PCSK9 抑制劑類藥物之前對醫療保健成本的不負責任的預測。這些高估導致從一開始就存在著許多限制，病人難以獲得醫療服務。

At the ACC last month, 2 research teams, including one from Duke, presented data showing that patients' clinical characteristics were no different between those denied reimbursement for PCSK9 versus those approved, showing that payer utilization management processes were nothing but an arbitrary barrier to access.

上個月在 ACC 會議上，包括杜克大學在內的兩個研究團隊展示了數據，表明 PCSK9 治療被拒賠的患者與獲得批准的患者在臨床特徵上沒有區別，這表明支付方的利用管理流程只不過是人為設置的就醫障礙。

And just today, the FH Foundation published a peer-reviewed paper in the journal Circulation showing that 63% of FH patients and 58% of established ASCVD patients had their PCSK9 inhibitor claims rejected despite having sub-optimal LDL-C levels and being on moderate to high-intensity statins.

就在今天，FH 基金會在《循環》雜誌上發表了一篇同行評審論文，表明 63% 的 FH 患者和 58% 的已確診 ASCVD 患者的 PCSK9 抑製劑索賠被拒絕，儘管他們的 LDL-C 水平不理想，並且正在服用中高強度他汀類藥物。

Cardiovascular disease continues to be the #1 cause of death and disability in the world. And in a moment, Sean will remind us of the incredible outcome value that Repatha has demonstrated by its ability to reduce both MI and strokes.

心血管疾病仍然是全球首要的死亡和殘疾原因。稍後，肖恩將提醒我們，Repatha 具有降低心肌梗塞和中風發生率的驚人療效，展現了其卓越的價值。

This data, together with a groundswell of cardiology and patient pressure will result in increasing levels of patient access. Repatha will continue to grow for many years to come, making it one of the largest innovative assets Amgen has brought to market.

這些數據，加上心臟病學界和患者的強烈呼聲，將導致患者就醫機會的增加。Repatha 將在未來多年持續成長，成為安進公司推向市場的最大創新資產之一。

Let me conclude by saying a few words about erenumab and our recently announced expanded collaboration with Novartis. We believe that partnering with Novartis, a company that is well positioned in the neuroscience space, will enable us to maximize the launch of this first-in-class product.

最後，我想簡單談談erenumab以及我們最近宣布與諾華擴大合作的情況。我們相信，與在神經科學領域佔據優勢地位的諾華公司合作，將使我們能夠最大限度地推廣這款同類首創產品。

We believe that erenumab will offer a strong value proposition to millions of patients suffering from chronic or episodic migraines.

我們相信，erenumab 將為數百萬患有慢性或發作性偏頭痛的患者帶來巨大的價值。

Let me close by thanking all of the Amgen staff that worked so hard and tirelessly to get our important products to patients around the world.

最後，我要感謝安進公司所有員工，感謝他們辛勤工作、不懈努力，才將我們重要的產品送到世界各地的病人手中。

Sean?

肖恩？

Thanks, Tony, and good afternoon. I'll begin my comments today with Repatha. As you know, we presented the results of our Repatha cardiovascular outcome study at the American College of Cardiology meetings in March with simultaneous publication in the New England Journal of Medicine. This represented a major step on the path of getting this therapy to the patients who so desperately need it.

謝謝你，托尼，下午好。今天我先從瑞百莎（Repatha）說起。如你所知，我們在 3 月的美國心臟病學會會議上發表了我們的 Repatha 心血管結果研究結果，並同時在《新英格蘭醫學雜誌》上發表了這項研究成果。這標誌著在將這種療法帶給迫切需要的患者方面邁出了重要一步。

This study had several objectives. First, to validate the PCSK9 mechanism with respect to cardiovascular outcomes. Second, to establish the safety of reaching unprecedented low LDL levels. Recall that 25% of patients on the Repatha arm had on-treatment LDLs below 19. And third, to understand whether the linear relationship established by statins and ezetimibe between LDL and cardiovascular risk continues down to very low LDL levels as the human genetics had suggested. The study gave clear, positive results on all of these objectives.

本研究有幾個目標。首先，驗證 PCSK9 機制與心血管結果之間的關係。第二，要確定達到前所未有的低LDL水準的安全性。回想一下，Repatha 組有 25% 的患者在治療期間 LDL 低於 19。第三，要了解他汀類藥物和依折麥佈在低密度脂蛋白和心血管風險之間建立的線性關係是否像人類遺傳學所顯示的那樣，在非常低的低密度脂蛋白水平下仍然存在。該研究在所有這些目標上都取得了明確的積極成果。

The results also validated our dosing approach of maximally inhibiting PCSK9 with Repatha, and that when it comes to LDL, as we begin to hear cardiologists coin at the ACC, "lowest is best."

結果也驗證了我們使用 Repatha 最大限度地抑制 PCSK9 的給藥方法，並且正如我們在 ACC 上開始聽到心臟病專家所說的那樣，對於 LDL 而言，「越低越好」。

Importantly, outcomes data from Pfizer's discontinued PCSK9 program were presented and also published in the New England Journal of Medicine, confirming the efficacy seen in our study and demonstrating that not all PCSK9 antibody therapies are the same with respect to off-target liabilities.

重要的是，輝瑞公司已終止的 PCSK9 計畫的結果數據也已在《新英格蘭醫學雜誌》上發表，證實了我們研究中觀察到的療效，並表明並非所有 PCSK9 抗體療法在脫靶風險方面都相同。

Now there's been a fair amount of speculation in the press and elsewhere about the magnitude of the risk reduction observed in our studies, so I'm going to spend a bit of time on the results. We have found that the vast preponderance of experts in this field view this study as highly successful in terms of the observed effect size. Essentially, the results are exactly as what would have been achieved had one been able to reduce LDL to the same degree with additional statin therapy, were it possible to do so without unacceptable toxicity.

現在媒體和其他地方對我們研究中觀察到的風險降低幅度進行了相當多的猜測，所以我將花點時間談談結果。我們發現，該領域的絕大多數專家認為，就觀察到的效果大小而言，這項研究非常成功。從本質上講，如果能在不產生不可接受的毒性的情況下，透過額外的他汀類藥物治療將 LDL 降低到同樣的程度，那麼所取得的結果就與此完全相同。

Specifically, experts understand that the treatment lag that occurs in the first year of therapy, a phenomenon seen in all lipid-lowering trials in this type of population, represented a much larger proportion of the median time on therapy in our study, which was just over 2 years, versus the average 5.5-year-long statin study.

具體來說，專家們了解到，在治療的第一年會出現治療滯後現象，這是所有針對這類族群的降血脂試驗中都會出現的現象。在我們的研究中，治療滯後所佔的中位治療時間比例要大得多，我們的研究時間略超過 2 年，而他汀類藥物研究的平均治療時間為 5.5 年。

They also understand that adjusting appropriately for duration of therapy, the results line up extremely well with the Cholesterol Treatment Trialists' Collaboration, or CTTC meta-analysis.

他們也了解到，透過適當調整治療持續時間，結果與膽固醇治療試驗協作組（CTTC）的統合分析非常吻合。

When one looks at the prespecified landmark analysis for this chronic therapy after the first year when the treatment lag is over and the true chronic value of the therapy can be assessed accurately, the risk reductions in myocardial infarction, 35%; stroke, 24%; and revascularization, 28%, are quite impressive, particularly in the setting of such a remarkably clean safety profile.

當人們在第一年治療滯後期結束後，對這種慢性療法進行預先設定的里程碑分析，並準確評估該療法的真正慢性價值時，心肌梗塞風險降低 35%；中風風險降低 24%；血管重建風險降低 28%，這些結果令人印象深刻，尤其是在安全性如此之高的情況下。

Experts also understand why one should not have anticipated an impact on CV mortality in such a study, and I would refer those who are interested to an excellent editorial on this subject published recently in the Journal of Clinical Lipidology.

專家們也明白為什麼不應該預料到此類研究會對心血管死亡率產生影響，對此感興趣的人可以參考最近發表在《臨床脂質學雜誌》上的一篇關於此主題的優秀社論。

And to just remind us of the clinical reality here, many millions of patients, like those in our outcomes study have a high annual risk of CV events despite maximally tolerated statins and have no other therapeutic alternative to take their LDLs down to levels that significantly protect them from such events. In fact, we were all surprised by the fact that despite optimized therapy with best standard of care, including high-intensity statins, patients in the placebo arm of our CV outcomes study had an annual event rate of almost 10%, which clearly demonstrates the unmet need here, as event rates in the real world are significantly higher than those seen in clinical trial settings.

為了提醒我們這裡存在的臨床現實，數百萬患者（例如我們結果研究中的患者）儘管服用了最大耐受劑量的他汀類藥物，但每年發生心血管事件的風險仍然很高，而且沒有其他治療方案可以將他們的低密度脂蛋白降低到足以顯著保護他們免受此類事件侵害的水平。事實上，儘管我們採用了最佳標準治療方案（包括高強度他汀類藥物），但我們心血管結局研究安慰劑組的患者年事件發生率仍接近 10%，這讓我們都感到驚訝。這清楚地表明了這裡存在著未被滿足的需求，因為現實世界中的事件發生率明顯高於臨床試驗環境中的事件發生率。

Now one of our highest priorities is to ensure these results are reflected in the Repatha label as soon as possible, and we're targeting regulatory submissions by midyear.

現在，我們最重要的任務之一是確保這些結果盡快反映在 Repatha 的標籤上，我們的目標是在年中之前提交監管申請。

I'd also note that the Repatha 420-milligram single-dose delivery option was recently approved in Europe.

我還想指出，Repatha 420毫克單劑量給藥方案最近已在歐洲獲得批准。

Turning to oncology. We completed XGEVA regulatory submissions in the U.S. and Europe for the prevention of skeletal-related events in multiple myeloma patients, providing a potential new treatment option for patients, many of whom are not able to avail themselves of alternative therapies due to renal insufficiency.

轉向腫瘤學。我們已完成 XGEVA 在美國和歐洲的監管申報，用於預防多發性骨髓瘤患者的骨骼相關事件，為患者提供了一種潛在的新治療選擇，其中許多患者由於腎功能不全而無法接受其他療法。

In multiple myeloma, we received the overall survival data from the ENDEAVOR study in relapsed or refractory patients, which confirmed the superiority of KYPROLIS plus dexamethasone over Velcade plus dexamethasone. In fact, ENDEAVOR was the first head-to-head study to demonstrate a survival benefit versus a current standard of care regimen in this setting and we're preparing to submit these results to regulators as well.

在多發性骨髓瘤中，我們從 ENDEAVOR 研究獲得了復發或難治性患者的總存活期數據，證實了 KYPROLIS 加地塞米松優於 Velcade 加地塞米松。事實上，ENDEAVOR 是第一個直接比較該療法與目前標準治療方案療效的研究，我們正準備將這些結果提交給監管機構。

We also remain on track to begin enrollment this quarter in our Phase III study of KYPROLIS in combination with Darzalex in relapsed or refractory multiple myeloma and also recently began enrolling a Phase Ib study of new formulations of Oprozomib.

我們仍按計畫於本季開始招募 KYPROLIS 與 Darzalex 聯合治療復發或難治性多發性骨髓瘤的 III 期研究患者，並且最近也開始招募 Oprozomib 新製劑的 Ib 期研究患者。

Turning to our immuno-oncology programs, I'll begin with our BiTE platform. We were very pleased that FDA granted BLINCYTO priority review for our recent sBLA that includes overall survival data from our Phase III study to support conversion from accelerated to full approval. The application also includes new data in Philadelphia chromosome positive relapsed or refractory acute lymphoblastic leukemia, a small population with an area of significant unmet need. We also continue to roll out our Phase II/III BLINCYTO program in diffuse large B-cell lymphoma, the most common form of high-grade non-Hodgkin's lymphoma.

接下來談談我們的免疫腫瘤學項目，我將從我們的 BiTE 平台開始。我們非常高興 FDA 授予 BLINCYTO 優先審查資格，我們最近提交的補充生物製品許可申請 (sBLA) 包含了來自 III 期研究的總生存期數據，以支持從加速批准轉為完全批准。該申請還包括費城染色體陽性復發或難治性急性淋巴細胞白血病的新數據，這是一個小眾群體，存在著巨大的未滿足需求。我們也將繼續推進針對瀰漫性大B細胞淋巴瘤（最常見的高級別非何杰金氏淋巴瘤）的 II/III 期 BLINCYTO 計畫。

We also have the opportunity in a recent American Association for Cancer Research annual meeting, to present preclinical data from some of our new BiTE programs, including half-life extended constructs.

在最近舉行的美國癌症研究協會年會上，我們也有機會展示我們一些新的BiTE計畫的臨床前數據，包括半衰期延長的構建體。

We continue to make good progress with the investigation of IMLYGIC in combination with checkpoint inhibitors, and we'll be presenting the results of our Phase II study in combination with YERVOY at ASCO, as well as some very interesting human biomarker data at the Congress of the European Association of Dermato Oncology.

我們在 IMLYGIC 與檢查點抑制劑聯合用藥的研究方面繼續取得良好進展，我們將在 ASCO 上公佈 IMLYGIC 與 YERVOY 聯合用藥的 II 期研究結果，並在歐洲皮膚腫瘤學會大會上公佈一些非常有趣的人類生物標記數據。

Finally in the early stage immuno-oncology pipeline, we're making progress in our Advaxis collaboration and have an investigational new drug application in place for a personalized neoantigen-targeted approach to cancer immunotherapy.

最後，在早期免疫腫瘤學研發管線中，我們與 Advaxis 的合作取得了進展，並已提交了針對癌症免疫療法的個人化新抗原標靶方法的研究性新藥申請。

In our bone therapeutic area, our collaboration with UCB on EVENITY continues to advance, and we look forward to our July U.S. PDUFA date for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

在我們的骨骼治療領域，我們與 UCB 在 EVENITY 上的合作持續推進，我們期待著 7 月在美國獲得 PDUFA 批准，用於治療停經後婦女骨質疏鬆症，這些婦女骨折風險增加。

Ahead of this, we expect the primary analysis of our active-controlled fracture study, ARCH, in postmenopausal women with osteoporosis in the near future. I will remind you that the upcoming primary analysis will include the clinical fracture and vertebral fracture primary co-endpoints, as well as an interim analysis of the event-driven non-vertebral fracture study secondary endpoint. If statistical significance is not achieved at this interim analysis, the study will continue until the final analysis some months later.

在此之前，我們預計在不久的將來會公佈針對停經後骨質疏鬆症女性的主動控制骨折研究 ARCH 的主要分析結果。我在此提醒各位，即將進行的主要分析將包括臨床骨折和椎體骨折的主要共同終點，以及事件驅動的非椎體骨折研究次要終點的中期分析。如果本次中期分析未達到統計意義，則研究將繼續進行，直到幾個月後的最終分析。

We designed ARCH in this manner to ensure adequate powering at the non-vertebral fracture endpoint. I would also point out that compared to the placebo-controlled FRAME study, the ARCH study compares EVENITY followed by alendronate to antiresorptive therapy with alendronate throughout the study period. These sequences are being assessed in a higher-risk population than our FRAME study, with all subjects in ARCH required to have prevalent fracture. This was possible given the active comparator design, and we were not exposing these higher-risk patients to placebo.

我們以這種方式設計 ARCH，是為了確保在非椎體骨折終點有足夠的功率。我還想指出，與安慰劑對照的 FRAME 研究相比，ARCH 研究比較了 EVENITY 治療後使用阿崙膦酸鈉與在整個研究期間使用阿崙膦酸鈉進行抗骨吸收治療的效果。這些序列正在比我們的 FRAME 研究風險更高的群體中進行評估，ARCH 中的所有受試者都必須有既往骨折史。這是因為採用了活性對照設計，我們也沒有讓這些高風險患者接觸安慰劑。

If you recall, in the FRAME study, the event rate for non-vertebral fractures was much lower than expected, and at 12 months, the non-vertebral relative risk reduction was 25% in the EVENITY-treated patients but was not statistically significant.

如果您還記得，在 FRAME 研究中，非椎體骨折的發生率遠低於預期，12 個月時，EVENITY 治療患者的非椎體相對風險降低了 25%，但並不具有統計意義。

In an exploratory analysis reported at ASBMR, the relative risk reduction at 2 years in FRAME was 25% with a nominal P value that was less than 0.05. We recently conducted the 3-year analysis of this study, which again demonstrated nominal significance for non-vertebral fracture demonstrating that a year of EVENITY therapy still had high treatment impact through year 3 despite the fact that the control group received a very potent antiresorptive agent with Prolia in years 2 and 3.

在 ASBMR 報告的一項探索性分析中，FRAME 2 年時的相對風險降低為 25%，名目 P 值小於 0.05。我們最近對這項研究進行了 3 年的分析，結果再次表明，對於非椎體骨折而言，EVENITY 治療一年後在第 3 年仍然具有很高的治療效果，儘管對照組在第 2 年和第 3 年接受了非常有效的抗吸收劑 Prolia 治療。

Within our neuroscience collaboration with Novartis,

在我們與諾華公司的神經科學合作中，

we had the opportunity to present the results from our 2 Phase III erenumab studies in episodic migraine at the American Academy of Neurology annual meeting yesterday. The data demonstrated the robust and consistent effect of inhibiting the CGRP receptor with erenumab. And feedback from experts at the meeting have been very positive, with many viewing this as a potentially game-changing therapy for a debilitating, highly symptomatic disease. We look forward to making first-in-class regulatory submissions for erenumab that incorporate our episodic and chronic data later this quarter.

昨天，我們有機會在美國神經病學會年會上展示了我們針對發作性偏頭痛的 2 項 III 期 erenumab 研究的結果。數據表明，使用erenumab抑制CGRP受體具有穩健且一致的效果。與會專家的回饋非常積極，許多人認為這是一種可能改變這種使人衰弱、症狀嚴重的疾病的療法。我們期待在本季稍後提交 erenumab 的首創監管申請，其中將包含我們的發作性和慢性數據。

AMG 301, our PAC 1 antibody for migraine, also continues to progress. We've seen encouraging pharmacodynamic activity in our Phase I study in normal subjects and are currently designing a Phase II program in migraineurs, which we expect to begin later this year.

我們用於治療偏頭痛的 PAC 1 抗體 AMG 301 也持續進展。我們在正常受試者的 I 期研究中看到了令人鼓舞的藥效學活性，目前正在設計針對偏頭痛患者的 II 期研究方案，預計將於今年稍後開始。

Also in the quarter, Phase III enrollment in Alzheimer's disease began for the small molecule BACE inhibitor AMG 520 we are developing with Novartis.

本季度，我們與諾華公司共同開發的小分子 BACE 抑制劑 AMG 520 開始在阿茲海默症領域進行 III 期臨床試驗。

In our inflammation collaboration with AstraZeneca/MedImmune, I am pleased to provide a program update for AMG 157 or tezepelumab, our monoclonal antibody that inhibits thymic stromal lymphopoietin or TSLP. TSLP is an epithelial-derived cytokine, produced in response to pro-inflammatory stimuli that drives inflammatory responses. TSLP expression is increased in the airways of patients with asthma, the magnitude correlating with the severity of disease.

在我們與阿斯特捷利康/MedImmune的發炎合作中，我很高興地向大家介紹AMG 157或tezepelumab的計畫進展，這是一種抑制胸腺基質淋巴細胞生成素（TSLP）的單株抗體。TSLP 是一種上皮細胞衍生的細胞因子，在促發炎刺激下產生，可驅動發炎反應。氣喘患者氣道中 TSLP 表現增加，其程度與疾病的嚴重程度有關。

Some of you may recall that our Phase Ib data were quite compelling and were published in the New England Journal of Medicine in 2014.

你們當中有些可能還記得，我們​​的 Ib 期數據非常有說服力，並於 2014 年發表在《新英格蘭醫學雜誌》上。

Together with AZ MedImmune, we've now received the results from a large, double-blind, Phase IIb study in patients with inadequately controlled severe asthma, in which AMG 157 demonstrated a significant reduction in the rate of asthma exacerbations compared to placebo at 52 weeks, successfully meeting the primary endpoint.

我們與 AZ MedImmune 合作，現已收到一項針對嚴重氣喘控制不佳患者的大型雙盲 IIb 期研究的結果，該研究顯示，AMG 157 在 52 週時顯著降低了氣喘急性發作率，與安慰劑相比，成功達到了主要終點。

This is a very encouraging result and together with AZ MedImmune we are currently evaluating the potential for this agent to address a broad population of patients with severe asthma.

這是一個非常令人鼓舞的結果，我們目前正與 AZ MedImmune 一起評估該藥物治療重度氣喘患者的潛力。

Briefly in nephrology, the first quarter, we also received approval for Parsabiv, our innovative IV calcimimetic that is administered thrice weekly at the end of dialysis for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease.

簡而言之，在腎臟病學領域，第一季度，我們的創新靜脈注射擬鈣劑 Parsabiv 也獲得了批准，該藥物在透析結束時每週給藥三次，用於治療慢性腎臟病患者的繼發性副甲狀腺功能亢進症。

And lastly, in biosimilar news from Europe, we received approval for AMGEVITA, our biosimilar HUMIRA for all available indications and submitted ABP 980, our biosimilar Herceptin for approval.

最後，在歐洲生物相似藥方面，我們的生物相似藥 HUMIRA 的仿製藥 AMGEVITA 已獲準用於所有可用的適應症，並且我們的生物類似藥 Herceptin 的仿製藥 ABP 980 已提交審批。

In closing, I'd like to acknowledge our staff for advancing these important programs on behalf of patients.

最後，我要感謝我們的員工為病患推動這些重要專案所做的貢獻。

Bob?

鮑伯？

Okay, thank you, Sean. I know we've taken more time than usual in our introductory remarks, so let's go straight to questions, Derek, and just please remind our callers of the process for the next step.

好的，謝謝你，肖恩。我知道我們的開場白比平常花的時間要長，所以德里克，讓我們直接進入提問環節吧，也請你提醒一下來電者下一步的流程。

(Operator Instructions) And your first question comes from the line of Terence Flynn with Goldman Sachs.

（操作員說明）你的第一個問題來自高盛的特倫斯·弗林。

Maybe just a two-part on Repatha. First, Tony, can you comment if the payers appreciate the details of the FOURIER data that Sean walked through? And then it looks like net price might have taken a step down in the U.S. in the first quarter. Just wonder if you can confirm that and any additional commentary that you can provide.

或許可以寫兩篇關於瑞百莎的文章。首先，Tony，你能否評價一下付款方是否理解Sean詳細講解的FOURIER數據？然後看來，美國第一季的淨價可能有所下降。想請您確認一下，並補充說明一下。

Terence, sure. All our discussions with the payers have been really starting with the discussion on the Repatha outcomes data. And I don't think we've had any pushback at all in terms of people really understanding the robust value. We'll continue to work with them, obviously. Each one of them has agreed to go back and relook at the utilization and management criteria as we speak. There does appear to be a slight adjustment in the net price. One was due to a small accounting adjustment; and two, of course, we book our patient copay program to the net price. And the first quarter is normally a lot higher than second, third or fourth. So we see that normalizing as we go forward.

特倫斯，當然可以。我們與付款方的所有討論實際上都是從討論 Repatha 的結果數據開始的。而且我認為，就人們真正理解其穩健價值而言，我們完全沒有遇到任何阻力。我們當然會繼續與他們合作。目前，他們都同意重新審視利用率和管理標準。淨價似乎略有調整。其中一項是由於小的會計調整；第二項當然是，我們將患者的共同支付計劃記入淨價。通常情況下，第一季的業績遠高於第二、第三或第四季。所以我們看到這種情況會隨著時間的推移而逐漸正常化。

And your next question comes from the line of Matthew Harrison with Morgan Stanley.

你的下一個問題來自摩根士丹利的馬修·哈里森。

Tony, thanks for the detail on Enbrel. I'm sure as you appreciate, there's a lot of questions that people have on that. If I can just ask 2 points there, I mean, you cited a market slowdown which you think will improve throughout the rest of the year. Could you just talk about your confidence around that? And beyond some of the weekly data points, are there other reasons to believe that, broadly, that the market is not slowing? And then second, it seems to me that the impact on price in the first quarter is higher than you've seen in quarters past even when thinking about copay assistance and some of the other factors. Is there anything else going on there? And what's your confidence about price leveling out for the year?

Tony，謝謝你詳細介紹恩利（Enbrel）。我相信您也明白，大家對此有很多疑問。如果我只能問兩點的話，我的意思是，您提到了市場放緩，您認為這種情況會在今年餘下的時間裡有所改善。能談談您在這方面的自信嗎？除了每週的一些數據點之外，還有其他理由相信，整體而言，市場並沒有放緩嗎？其次，在我看來，即使考慮到共同支付援助和其他一些因素，第一季的價格影響也比過去幾季要高。那裡還有其他事情發生嗎？你對今年價格趨於平穩有多大信心？

Thanks, Matt. So as you know, with Enbrel as a retail product, about 97% of the volume is reported on a script basis, so we can track it quite tightly. For the quarter, it was definitely down -- both rheumatology and dermatology. When I look at it sequentially, January, February, March, and then as I see it going into April, each one of those months have shown an incremental growth both in terms of DOT as well as prescriptions and in terms of growth. So January was down a lot, February was better than January, March was better than February, and April is starting to look much better than March as well. From a net price -- we don't see a dramatic change in the net price. Some of the new contracts are coming into place, but our outlook on net price for 2017 hasn't changed at all. And when I look at abandonment rates -- the abandonment rates in the first quarter are pretty similar for Enbrel to what they were in the fourth quarter or the third quarter last year.

謝謝你，馬特。如您所知，恩利作為零售產品，約 97% 的銷售量是根據處方量報告的，因此我們可以對其進行非常嚴格的追蹤。本季度，風濕病科和皮膚科的就診量都明顯下降。從一月、二月、三月，到四月，每個月的 DOT 和處方量以及成長率都呈現逐步成長的趨勢。所以一月份情況很差，二月比一月好，三月比二月好，四月的情況也開始比三月好很多。從淨價來看——我們沒有看到淨價發生劇烈變化。一些新合約正在生效，但我們對 2017 年淨價的預期絲毫沒有改變。當我查看放棄率時——恩利（Enbrel）第一季的放棄率與去年第四季或第三季的放棄率非常相似。

And Matthew, maybe just a big picture here, when we look at the flow of patients into the -- anti-inflammation space, particularly rheum and derm, we see no reason in the marketplace that the trend of an increasing number of patients into this therapy would have abruptly changed between the fourth and the first quarter. So we think that we'll continue to see growth in the underlying demand for this kind of products.

馬修，或許從大局來看，當我們觀察進入抗炎領域（特別是風濕病和皮膚病領域）的患者流量時，我們認為市場上沒有任何理由表明，接受這種療法的患者人數不斷增加的趨勢會在第四季度和第一季之間突然改變。因此，我們認為這類產品的潛在需求將持續成長。

And your next question comes from the line of Ying Huang with Bank of America Merrill Lynch.

你的下一個問題來自美國銀行美林證券的黃穎。

I have a question on Repatha. How much have you heard from the physicians in terms of feedback that they have to wait for a treatment guideline change by, let's say, ACC or AHA before they start prescribing more Repatha? And if that's the case, when do you think those professional organizations will change the guideline?

我有一個關於Repatha的問題。您是否曾從醫生那裡聽到這樣的回饋：他們需要等待治療指南的改變，例如由 ACC 或 AHA 制定的指南，才能開始開立更多的 Repatha 處方？如果真是這樣，你認為這些專業組織何時會修改指導方針？

Yes, I think it's probably a subtle question that you're asking there, Ying, so why don't we just take a moment to really step through it. Tony, why don't you go ahead and take the first.

是的，英，我覺得你問的這個問題可能比較微妙，所以我們不妨花點時間仔細分析一下。東尼，你先來拿第一張。

So all our discussions with cardiologists have been around their frustration of the administrative burden that's been placed upon them to get a prescription for appropriate patients. A lot of them are having to hire full-time nurses to spend the entire day chasing down required patient data, to chase down interactions between the patient or between the physician and the respective payer or the PBM. The guidelines themselves clearly, in everyone's mind, would help move the decision-making and the utilization criteria a bit quicker. But our major conversation with physicians is not really around the guidelines, more around the inconvenience. From a guideline perspective, clearly both the AHA and the ACC are busy looking at the outcomes data. They have told us they are busy identifying position papers they wish to put forward, the NLA, the National Lipid Association is there, the Association of Preventive Cardiology -- run by doctor Seth Baum is in the process of looking at a revised set of guidelines, including a proposed set of utilization management criteria which they're proposing the PBMs and the payers should be using. In terms of guidelines themselves, both the AHA and the ACC have said it will take some time before they actually get to a final guideline change.

因此，我們與心臟科醫生的所有討論都圍繞著他們對為合適的患者開處方所承受的行政負擔的沮喪。許多醫院必須聘請全職護士，讓她們整天追蹤所需的病人數據，追蹤病人之間或醫生與相應付款人或藥品福利管理機構之間的互動。在大家看來，這些指導方針本身顯然有助於加速決策和利用標準的確定。但我們與醫師們的主要對話並非圍繞著指南展開，而是圍繞著指南帶來的不便。從指引的角度來看，美國心臟協會 (AHA) 和美國心臟病學會 (ACC) 顯然都在忙於研究結果數據。他們告訴我們，他們正忙於確定他們想要提出的立場文件，美國國家脂質協會 (NLA) 也參與其中，由塞思·鮑姆醫生領導的預防心臟病學協會正在研究一套修訂後的指南，其中包括一套擬議的利用管理標準，他們建議藥品福利管理機構 (PBM) 和支付方應該使用這些標準。就指引本身而言，美國心臟協會 (AHA) 和美國心臟學會 (ACC) 都表示，還需要一些時間才能最終確定指引的修改方案。

I think the important information here is that the data demonstrated that lower is better or, as Sean said and as we increasingly hear from experts in the field, lowest is best. And I think people recognize that the current guidelines are out of sync with that. So the data make the point clear, and we expect to see white papers and then, ultimately, changes in the guidelines. But for right now, the data are an important piece of getting people to understand how to manage this disease for patients.

我認為這裡的重要訊息是，數據表明越低越好，或者正如肖恩所說，正如我們越來越多地從該領域的專家那裡聽到的那樣，最低才是最好的。我認為人們也意識到，目前的指導方針與此不符。因此，數據清楚地表明了這一點，我們期待看到白皮書，並最終看到指南的改變。但就目前而言，這些數據對於讓人們了解如何為患者管理這種疾病至關重要。

Your next question comes from the line of Eric Schmidt with Cowen.

你的下一個問題來自 Eric Sc​​hmidt 與 Cowen 的合作系列。

Just as a follow-on to Ying's question, it sounds like the major bottleneck is this hassle factor, Tony, that physicians are being put through. And I guess I'm just wondering what kind of leverage Amgen has to reduce that factor? Can't payors just stay entrenched and say our policies are that we'll cover it, but we're going to make you go through x,y and z hoops and maintain the hassle factor and, I guess, the evidence of better medicine?

作為 Ying 問題的補充，Tony，聽起來主要的瓶頸在於醫生們所面臨的這些麻煩事。我想知道安進公司有哪些籌碼來降低這個因素？支付方難道不能固守成規，聲稱我們的政策是我們會承擔費用，但我們會讓你經歷 x、y 和 z 等繁瑣程序，從而維持這種麻煩感，而且，我想，還能證明醫療水平更高嗎？

So, Eric, I don't think I have spoken to a single cardiologist or general practitioner who hasn't commented on how onerous the process is to gain access to these products. I think without doubt the third-party organizations -- the professional organizations such as the ACC, the AHA, as well as patient organizations such as the FH Foundation are the ones who are running the research work at the moment, including Duke, as I said. Who actually looked at those patients who received the PCSK9 and those who didn't and actually show there's no clinical difference in the patients themselves. This type of burden, I think, is going to start putting the pressure on the payers. Talking to payers, they themselves are agreeing with us that the clinical data is important, and they need to expand access to appropriate patients. So we'll continue to drive that interaction with them.

所以，艾瑞克，我想我還沒遇到哪個心臟病專家或全科醫生不提到取得這些產品的過程有多麼繁瑣。毫無疑問，目前進行研究工作的主要是第三方組織——專業組織如 ACC、AHA，以及病患組織如 FH 基金會，正如我所說，也包括杜克大學。真正研究過接受 PCSK9 治療的患者和未接受治療的患者的人，結果表明，患者本身並沒有臨床差異。我認為，這種負擔將會開始給支付方帶來壓力。與支付方交談後，他們也認同臨床數據的重要性，並表示需要擴大對合適患者的覆蓋範圍。所以我們會繼續加強與他們的互動。

Your next question comes from the line of Cory Kasimov with JPMorgan.

你的下一個問題來自摩根大通的科里·卡西莫夫。

I have a pre-commercial question on erenumab. I wonder if you can comment on early interactions you're having with payers on that front, or maybe just general market research for the product. I guess, specifically, I'm wondering how much of an impediment you expect access to be in the early days of that pending launch and how much your research may have factored into this strategic decision to further engage with Novartis.

我有一個關於erenumab上市前的問題。我想知道您能否談談您目前與支付方在這方面進行的早期互動，或者能否談談該產品的整體市場調查情況。具體來說，我想知道您認為在即將上市的初期階段，准入問題會造成多大的阻礙，以及您的研究在多大程度上影響了您與諾華進一步合作的這一戰略決策。

Let me start, Cory, by just telling you about an interaction I had with my counterpart at Novartis yesterday. He and I have both been in recent contact with neurologists who specialize in treating patients with chronic migraine. And the two of us are quite elated at the level of excitement we're feeling amongst these physicians about having, for the first time in decades, a treatment opportunity to really help people who have this debilitating disease. It truly is one of those symptomatic diseases where if you got a migraine, you really know about it, and it impacts how you run your life, can you run your life or can you be a good caregiver. We are starting our discussions with the payers right now. We are helping them see the data from a clinical perspective. Obviously, the real negotiation can only start once we have the label and we look forward to having that in the next couple of months or so.

科里，讓我先跟你談談我昨天和諾華公司的一位同事的交流吧。我和他最近都與專門治療慢性偏頭痛患者的神經科醫生有過聯繫。我們兩人都感到非常高興，因為這些醫生們對幾十年來第一次有機會真正幫助患有這種衰弱性疾病的人感到興奮。這確實是一種症狀明顯的疾病，如果你得了偏頭痛，你會很清楚地感受到它，它會影響你的生活，影響你是否能正常生活，或者你是否能成為一個好的照顧者。我們現在就開始與付款方進行磋商。我們正在幫助他們從臨床角度看待數據。顯然，真正的談判只有在我們拿到唱片公司名稱後才能​​開始，我們期待在接下來的幾個月左右拿到唱片公司名稱。

And your next question comes from the line of Josh Schimmer with Piper Jaffray.

你的下一個問題來自 Josh Schimmer 和 Piper Jaffray 的對話。

Maybe you can help us understand the market segmentation in asthma and (inaudible) perhaps (inaudible) versus some of the other novel biologics targeting the IL4 or IL5 pathways.

或許您可以幫助我們了解氣喘和（聽不清楚）或許（聽不清楚）與其他一些針對 IL4 或 IL5 路徑的新型生物製劑的市場區隔。

Okay, question was a little bit hard to hear, Josh. But I think, Sean, why don't you take the first crack at it?

好的，喬希，這個問題有點難聽清楚。但我認為，肖恩，為什麼不讓你先嘗試呢？

Yes, what I would say is that it's still early days for a lot of the therapies that are still in development. But as you look across the biologics landscape in asthma, there's a few things that are at play. One is that, in aggregate, asthma is an enormous opportunity from the perspective of the unmet need and the number of patients who are, for example, having to take courses of oral corticosteroids throughout the course of the year to manage their disease, which is very problematic for them.

是的，我想說的是，很多療法仍處於研發初期。但縱觀氣喘生物製劑領域，有幾個因素在起作用。一方面，從未滿足的需求以及例如全年需要服用口服皮質類固醇來控制病情的患者數量來看，氣喘總體上是一個巨大的機遇，這對他們來說非常麻煩。

And I think what you're seeing is many of the mechanisms that are either out there now in biologics or being developed currently are segmented to populations that, for example, have high eosinophilia counts, atopic phenotype, et cetera. And in the case of TSLP, what we like about TSLP is it is a very upstream kind of mediator of this inflammation. And our expectation is that we could have a very broad impact on patients with activity across a spectrum of patient phenotypes within the asthma disease spectrum which would make it a very attractive therapeutic option.

我認為你現在看到的是，許多生物製劑中已經存在或正在開發的機制，都針對特定人群，例如嗜酸性粒細胞計數高、特應性表型等。而對於 TSLP 來說，我們喜歡 TSLP 的原因是它是一種非常上游的發炎介質。我們期望它能對氣喘疾病譜中各種表型的患者產生非常廣泛的影響，這將使其成為一種非常有吸引力的治療選擇。

And your next question comes from the line of Ronny Gal with Bernstein.

你的下一個問題來自 Ronny Gal 與 Bernstein 的對話。

I guess, the Supreme Court have been looking at biosimilar today. In the case they side with you and find that shall means will, can you give like kind of a feel for what will happen with the biosimilars that have already launched with Neulasta. Will they have to come back and do the full patent dance? Frankly, if you win this case, what does it mean in terms of delay of biosimilar Neulasta approvals or launches?

我猜，最高法院今天一直在關註生物相似藥的問題。如果他們站在你這邊，發現 shall 的意思是 will，你能否大致說明一下，已經與 Neulasta 一起上市的生物類似藥將會發生什麼情況？他們是否需要回來重新走一遍完整的專利申請流程？坦白說，如果你贏了這場官司，這對Neulasta生物類似藥的審批或上市會有什麼延遲？

Yes, I think there are a couple of things in your question there, Ronny. We'd tease apart the 2 pieces of it. First, as you know, Supreme Court reviewed this today, and so we'll know within a matter of weeks. I mean, obviously, we think the 180-day needs to be enforced as it was written in the law. But with respect, I think you must be referring to the short-acting competitors to NEUPOGEN.

是的，羅尼，我認為你的問題裡包含了一些內容。我們會把它分成兩個部分來分析。首先，正如您所知，最高法院今天審查了此案，因此我們將在幾週內知道結果。我的意思是，很顯然，我們認為必須按照法律規定執行 180 天的期限。但恕我直言，我認為您指的是 NEUPOGEN 的短效競爭對手。

No, I was talking about the patent dance for -- the patent dance impact of Neulasta biosimilar launches. Essentially if you win that, will the biosimilar Neulasta be delayed?

不，我指的是專利舞——Neulasta生物類似藥上市的專利舞影響。如果你贏了，生物相似藥Neulasta的上市時間會被延後嗎？

Well, I guess I'm not sure what you mean by delayed. I think, again, the big picture here, Ronny, is that we've known for some time that we'll face biosimilar competition. We're expecting that, that will happen for Neulasta. We're ready for that. You've seen the actions that we've been taking over the past couple of years to be ready for that. And we're ready to embrace the competition, and we've positioned the company from an operating expense standpoint with the knowledge that competition is coming. And we're launching medicines and entering markets that we think will help us grow beyond that. So the 180-day is obviously post-FDA approval, so we're watching different competitive products make their way through the regulatory pathway.

嗯，我不太明白你說的「延遲」是什麼意思。羅尼，我認為，從大局來看，我們早就知道我們將面臨生物相似藥的競爭。我們預計紐拉斯塔也會發生這種情況。我們已經做好準備。你們已經看到了我們過去幾年為應對這種情況所採取的行動。我們已經做好迎接競爭的準備，考慮到競爭即將到來，我們已經從營運費用的角度對公司進行了調整。我們正在推出藥品並進入我們認為有助於我們實現更大成長的市場。所以，180 天顯然是指獲得 FDA 批准後的 180 天，因此我們正在觀察不同的競爭產品如何透過監管途徑。

If I could then in terms of the guidance we've offered, there are none that have been approved yet to compete with Neulasta. There is one that's lined up, I think, in the third quarter here. So if it were approved and the 180-day stands, then that would imply, as we've indicated, that we could face competition as soon as late this year. And that's how our guidance is built right now.

如果可以的話，就我們提供的指導而言，目前還沒有任何藥物獲得批准可以與 Neulasta 競爭。我認為，第三季已經有一場比賽安排好了。因此，如果獲得批准，並且 180 天的期限仍然有效，那麼正如我們所指出的，這意味著我們最早可能在今年年底就面臨競爭。這就是我們目前指導方針的建構方式。

Your next question comes from the line of Alethia Young with Credit Suisse.

你的下一個問題來自瑞士信貸的 Alethia Young。

Just again on Neulasta, I know On Pro is picking up momentum. But I just -- I'm trying to figure out if you think -- how do you think this helps defend you against biosimilar share? I mean is it as simple as that the market is kind of remodeling itself and so like the kind of delays and prolonged some of the competition that you may see? Or is there some other dynamic we should be aware of?

關於 Neulasta，我知道 On Pro 的發展勢頭正在增強。但我只是——我想弄清楚你認為——你覺得這如何幫助你抵禦生物相似藥的市場份額？我的意思是，是不是市場正在經歷某種程度的自我重塑，所以才會出現一些延誤和競爭延長的情況？或者有其他我們應該注意的因素嗎？

Alethia, it's Tony. So let me go back to a comment I made on the last quarter earnings. Let's use MD Anderson as an example of probably one of the most premier, large oncology teaching centers in the country. It took MD Anderson almost -- just over 12 months to go through their P&T committee to get an agreement within the institution to start shifting patients to On Pro. And the rationale was they were really having a good look at the clinical value, the treatment protocols, the discharge protocols, and they finally agreed that this product was certainly worthwhile having. We spent a number of weeks training their 600 oncology nurses, so they were able to really identify the right patient, administer the drug before patients went home. And they have, therefore, changed the clinical practice. The feedback we get from both the oncology nurses, the oncologists themselves and patients, in fact, about the fact they no longer have to come back 24 hours later or a day after their chemotherapy, when they're in the middle of chemo-induced nausea and vomiting, is a huge advantage and allows them a better quality of life.

阿萊西亞，我是東尼。那麼，讓我回到我對上一季財報的評論。讓我們以MD安德森癌症中心為例，它可能是全國最頂尖、規模最大的腫瘤教學中心之一。MD 安德森癌症中心花了將近 12 個月的時間，才透過其 P&T 委員會的審批，在院內達成協議，開始將患者轉移到 On Pro 治療。他們的理由是，他們認真研究了該產品的臨床價值、治療方案和出院方案，最終一致認為該產品絕對值得擁有。我們花了幾個星期的時間培訓了他們的 600 名腫瘤科護士，以便他們能夠真正識別出合適的病人，並在病人回家前給他們用藥。因此，它們改變了臨床實踐。事實上，我們從腫瘤科護理師、腫瘤科醫生和患者那裡得到的回饋是，他們不必在化療後 24 小時或一天內返回醫院，那時他們正經歷化療引起的噁心和嘔吐，這是一個巨大的優勢，使他們的生活品質更高。

So we really believe that the benefit this drug brings is not simply a device, it's really something that allows patients to continue to live their lives whilst being treated for cancer. It also resulted in changes -- definitive changes in discharge protocols, which we think would take some time to be reversed if there's no other alternative.

因此，我們真心相信這種藥物帶來的益處不僅僅在於它是一種設備，它真正能夠讓患者在接受癌症治療的同時繼續正常生活。這也導致了出院流程的改變——徹底的改變，我們認為如果沒有其他替代方案，這些改變需要一段時間才能逆轉。

Yes, it's worth keeping in mind, the big picture here, Alethia, some data in a peer-reviewed publication from this week recognizing that there are 100,000 hospitalizations here in this country for patients who suffer from an infection while undergoing chemotherapy. And of course, that's what NEUPOGEN and Neulasta are designed to address. And any product like On Pro that can help prevent some number of those infections is an important product. So this is still -- there is still an important need in the marketplace, this innovative delivery device enables us to meet a large portion of that need.

是的，阿萊西亞，值得注意的是，本週同行評審出版物中的一些數據顯示，在這個國家，有 10 萬名患者在接受化療期間感染而住院治療。當然，NEUPOGEN 和 Neulasta 正是旨在解決這個問題。任何像 On Pro 這樣能夠幫助預防部分感染的產品都是重要的產品。所以，市場上仍然存在著重要的需求，而這種創新的輸送裝置使我們能夠滿足其中很大一部分需求。

Your next question comes from the line of Geoffrey Porges with Leerink Partners.

你的下一個問題來自 Leerink Partners 的 Geoffrey Porges。

Just a follow-up on the question about erenumab. Bob, could you take us through your thinking about the partnering decision? Because you are on a strong net cash position, you've got robust cash flow, you've got plenty of space in your R&D -- given the sequential trend, and yet you partner sort of 1 of your 2 late-stage products for what certainly looks like it's a fairly specialized prescriber base initially. So could you talk a little bit about that and then also how you'll be collaborating with Novartis on the launch, particularly who will be setting price and how you're thinking about price? Sorry, it's a complicated question.

關於erenumab的問題，我再補充一點。鮑勃，你能跟我們說說你當初做出合作決定的想法嗎？因為貴公司擁有強勁的淨現金狀況、充裕的現金流，研發方面也有足夠的空間——考慮到目前的趨勢——然而，貴公司卻將兩款後期產品中的一款與合作夥伴合作，而該合作夥伴最初的目標客戶群看起來相當專業。那麼，您能否談談這方面的情況，以及您將如何與諾華合作進行產品上市，特別是誰將制定價格，以及您是如何考慮定價的？抱歉，這個問題比較複雜。

No, that's fine, Jeff. We'll take it in 2 parts. Why don't I take the first piece, and we'll have Tony address some of the specifics of your question. We recognized and we're excited about the opportunity to have a first-in-class and a molecule that we think has a good chance to be best-in-class for a disease where there just aren't good therapies available today. So we're excited about that. But at the same time, Jeff, I think there is a specialty element to this that we don't have experience in. Novartis has been in the neurology, neuroscience field for some 60 odd years now, and so they have a real established track record there. And as we interact with them, first with respect to international markets, I think we came to realize there were opportunities to create a bigger opportunity by combining forces than by going it alone in the international markets. We've come to know and share and respect each other's capabilities over the time since that agreement went into place. And as we looked at the opportunity in the U.S. and our desire to make sure we resource this to win, including getting off to a strong start with the specialist prescribers, it was our view that our shareholders are going to be better served by our joining up with somebody that has a very established presence in this field. So that's our view and I think all of our interactions since then make us feel confident that, that was the right decision for the shareholders. But Tony, why don't you add your thoughts?

不，沒關係，傑夫。我們將分兩部分進行。不如我先回答第一個問題，然後讓托尼來具體解答你的疑問。我們認識到這是一個首創的機會，並且我們對此感到興奮，我們認為這種分子很有可能成為目前尚無有效療法的疾病的最佳療法。我們對此感到很興奮。但同時，傑夫，我認為這其中存在著一些我們不具備經驗的專業因素。諾華公司在神經病學、神經科學領域已有60多年的歷史，因此他們在該領域擁有非常成熟的業績記錄。當我們與他們互動，首先是在國際市場方面，我認為我們逐漸意識到，在國際市場上，透過聯合起來創造的機會比單打獨鬥要大得多。自從協議生效以來，我們逐漸了解、分享和尊重彼此的能力。當我們審視美國市場的機遇，以及我們確保投入資源贏得這場競爭的願望時，包括與專科處方醫生建立良好的開端，我們認為，與在該領域擁有穩固地位的公司合作，對我們的股東更有利。這就是我們的觀點，而且我認為從那時起我們所有的交流都讓我們確信，這對股東來說是正確的決定。東尼，為什麼不說說你的想法呢？

Sure. Well, I mean we've been working with Novartis now from a global research perspective and a global marketing perspective for some time. So the teams have gotten to know each other quite well. My counterpart and I have been drawn into these discussions with these experts, as I said, and he and I are becoming even more increasingly excited about the opportunity to deliver a first-in-class product like this to patients in need.

當然。嗯，我的意思是，我們已經從全球研究和全球行銷的角度與諾華公司合作了一段時間。所以兩隊隊員彼此已經相當了解了。正如我所說，我和我的同事也參與了與這些專家的討論，我們越來越興奮能有機會為有需要的患者提供如此一流的產品。

He and I both have experience in terms of launching products in the U.S. over the last 5 years or so, and we understand some of the barriers and some of the challenges. But we also understand the large unmet need over here. It's clear to us that a strong start in terms of having a clear group of physicians who realize the importance of treating patients properly is going to be important to place pressure on the entire payer system to ensure we can get access. They have a very good presence in the neuroscience market. The feedback we've had from third-party research has shown the team and the medical team are very well regarded. And this strong relationship in our mind will support the ability to launch fast, launch rapidly and be highly effective in the initial uptake. So they're a good team to be with. We'll work closely with them, and I know we can maximize our ability to bring value to patients.

在過去五年左右的時間裡，我和他都有在美國推出產品的經驗，我們了解其中的一些障礙和挑戰。但我們也了解到這裡存在著巨大的未滿足需求。我們很清楚，要取得良好的開端，首先需要有一群醫生認識到正確治療病人的重要性，這樣才能向整個支付系統施加壓力，確保我們能夠獲得醫療服務。他們在神經科學市場擁有非常強大的影響力。我們從第三方研究中獲得的回饋表明，該團隊和醫療團隊都備受好評。我們認為這種牢固的關係將有助於我們快速啟動、迅速推廣，並在初期階段取得顯著成效。所以和他們一起工作很愉快。我們將與他們密切合作，我知道我們可以最大限度地發揮自身能力，為患者帶來價值。

And Jeff, as regard to your questions about operational details, obviously, those are topics that we discuss with them in detail before we move forward. And we think we've got -- between the 2 of us, we think we've got those details worked out. But again, we're excited to have this partnership in hand, and we look forward to getting this molecule approved so we can get out and help patients with it.

傑夫，關於你提出的操作細節問題，顯然，這些都是我們在推進下一步工作之前會與他們詳細討論的話題。我們覺得──我們兩個之間，我們認為我們已經把這些細節都敲定了。但我們很高興能達成這項合作，並期待這種分子獲得批准，以便我們能夠用它來幫助患者。

Your next question comes from the line of Ian Somaiya with BMO Capital.

你的下一個問題來自 BMO Capital 的 Ian Somaiya。

Just another question on Repatha. You made a comment that payers could potentially make some changes over the coming months. I was just hoping you can clarify, are those changes in prior authorization or they're just payers being more diligent in making sure the right patients are getting access to therapy? As I think about ACC/AHA guideline changes and some of the answers you provided, do you need those changes -- do you need the new guidelines to state lower LDL goals? Or what else -- what are the type of changes could we see which would benefit PCSK9 class overall?

關於瑞百達（Repatha）還有個問題。你曾評論說，付款方可能會在未來幾個月做出一些改變。我只是想請您澄清一下，這些變化是指事先授權方面的改變，還是僅僅是支付方更加認真地確保合適的患者能夠獲得治療？考慮到 ACC/AHA 指南的變更以及您提供的一些答案，您是否需要這些變更——您是否需要新的指南規定更低的 LDL 目標？或者還有什麼其他可能的變化——哪些類型的變化會對 PCSK9 類疾病整體有利？

So Ian, it's Tony again. So I mean clearly, everything here is driven from the interpretation and understanding of our outcomes data that, fundamentally, this product, Repatha, on top of maximally tolerated statins which are the gold standard to date, is able to drive LDL down further and reduce even more dramatically the risk of heart attack and stroke. So the discussion with the payers are consistently around the utilization management criteria, to make sure that the burden is less onerous for physicians, that they and patients are able to get access to products quicker and faster. White papers or position papers from professional cardiology organizations are really essential to start paving the way to ensure we move towards the guidelines down the road. But they factor -- the good clinical data is what's important. Payers have said to us from the beginning that, yes, they see the drug lowers LDL, but they need to understand what that means. The outcomes data now shows you what that means and all our discussions have been if we had to renegotiate a contract, it is based around the payers wanting us to amend and make more simple the utilization management criteria.

伊恩，我又是東尼。所以很明顯，這裡的一切都源於我們對結果數據的解讀和理解，從根本上說，這種產品 Repatha，在最大耐受劑量的他汀類藥物（迄今為止的黃金標準）的基礎上，能夠進一步降低 LDL，並更顯著地降低心臟病發作和中風的風險。因此，與支付方的討論始終圍繞著利用管理標準展開，以確保減輕醫生的負擔，使他們和患者能夠更快地獲得產品。來自專業心臟病學組織的白皮書或立場文件對於為我們未來朝著相關指南的方向邁進至關重要。但它們並非決定性因素——重要的是良好的臨床數據。從一開始，支付方就對我們說，是的，他們看到這種藥物可以降低低密度脂蛋白膽固醇，但他們需要了解這意味著什麼。現在的結果數據表明了這意味著什麼，我們所有的討論都圍繞著，如果我們必須重新談判合同，那麼付款方希望我們修改並簡化利用管理標準。

And your next question comes from the line of Umer Raffat from Evercore ISI.

你的下一個問題來自 Evercore ISI 的 Umer Raffat。

I have 2 pipeline questions, if I may. On romosozumab, the upcoming ARCH trial, what percentage of patients were enrolled in Latin America? And secondly, on CGRP, I noticed you have a treadmill CV safety trial that wrapped up earlier in the year. Any update and/or feedback from that? And was that a study that FDA asked you to do?

如果可以的話，我有兩個關於管道方面的問題。在即將進行的 ARCH 試驗中，接受 romosozumab 治療的患者中，有多少百分比來自拉丁美洲？其次，關於 CGRP，我注意到你們今年早些時候完成了一項跑步機心血管安全試驗。有任何更新或反饋嗎？那項研究是FDA要求你做的嗎？

So with respect to ARCH, the percentage of patients in Latin America -- I don't remember an exact number but it is substantially less than it was in the FRAME study, but it is still meaningful. So I think it's about 30%, roughly. Whereas it was higher than that in FRAME. But I think it's important to recognize that it wasn't the part of the world that the drug was being administered that was the problem. It was the fact that the fracture rates in a placebo-controlled population, where physicians were very hesitant to put high-risk individuals into the trial because of the placebo arm, that the fracture rate was so low that we really didn't have any opportunity to demonstrate a further lowering of the fracture rate. And we don't expect that phenomenon in FRAME because the patients were -- that were enrolled were, by definition, by protocol, much higher risk. They had to have had prevalent fracture already, they had much lower T scores and so on because, in this case, patients are either getting romosozumab followed by alendronate or alendronate from the get-go with no placebo control. So I wouldn't focus so much around the question of Latin America, although that was where we saw the problem with the very low event rates. And then the other piece to keep in mind is that we do have an event-driven analysis for non-vertebral fracture in FRAME -- in ARCH, sorry, which we didn't have in FRAME and that also, kind of, as you know, addresses this event number powering kind of problem that you can run into which is essentially the wall we hit in FRAME. With respect to CGRP, I think it's a very good question. One of the things that I learned from talking with people at the meetings in Boston is that the real question in most neurologists' mind right now about the CGRP class remains long-term safety and tolerability. They're very impressed with the efficacy data, they're very impressed with the tolerability and safety that have been observed to date in relatively short kind of exposures in the Phase II and Phase III study. And so I think there's a number of things that we have been doing specifically as a company like we have over 3 years of long-term exposure in open-label extension studies. Other companies to our knowledge have not been doing this. We did the CV treadmill study on our own volition because we felt that, again, these were going to be the kind of questions that would exist in the marketplace. We have a number of preclinical and clinical studies, for example, on the impact on blood pressure and so on that have been done specifically to in anticipation of the kind of questions that prescribers will have around the long-term safety of the product. Many of these data are not broadly appreciated because they haven't come out in peer-reviewed publications, and they haven't been, necessarily, presented at -- in plenary-type presentations like the Phase III data were. But in aggregate, I think these are going to be important and potentially differentiating data for the product.

所以就 ARCH 而言，拉丁美洲的患者百分比——我不記得確切的數字了，但它比 FRAME 研究中的百分比要低得多，但仍然有意義。所以我認為大概是30%左右。而在 FRAME 中，它的值比這個值高。但我認為重要的是要認識到，問題不在於藥物使用的地區。事實是，在安慰劑對照人群中，骨折率非常低，醫生們因為安慰劑組的存在而非常猶豫是否要讓高風險個體參與試驗，因此我們實際上沒有任何機會證明骨折率可以進一步降低。我們預期 FRAME 研究不會出現這種現象，因為根據方案的定義，入組的病患風險要高得多。他們肯定已經患有骨折，他們的 T 值要低得多等等，因為在這種情況下，患者要么接受羅莫索單抗治療，然後接受阿崙膦酸鈉治療，要么從一開始就接受阿崙膦酸鈉治療，而沒有安慰劑對照。所以我不會太在意拉丁美洲的問題，儘管我們在那裡看到了事件發生率非常低的問題。還有一點要記住的是，我們在 FRAME 中針對非椎體骨折進行了事件驅動分析——抱歉，是在 ARCH 中，而 FRAME 中沒有這個功能。而且，如您所知，這也解決了您可能會遇到的事件數量驅動問題，這基本上就是我們在 FRAME 中遇到的瓶頸。關於CGRP，我認為這是一個很好的問題。我在波士頓的會議上與人們交談後了解到，目前大多數神經科醫生對 CGRP 類藥物最關心的問題仍然是其長期安全性和耐受性。他們對療效數據印象深刻，對 II 期和 III 期研究中相對較短的暴露時間內觀察到的耐受性和安全性也印象深刻。因此，我認為我們公司一直在做一些具體的事情，例如，我們在開放標籤擴展研究中進行了超過 3 年的長期接觸。據我們所知，其他公司還沒有這樣做。我們自願進行心血管跑步機研究，因為我們覺得，這些又是市場上會存在的問題。例如，我們進行了許多臨床前和臨床研究，研究其對血壓的影響等等，這些研究都是專門為了解答處方醫生可能對產品長期安全性提出的問題而進行的。許多此類數據並未得到廣泛重視，因為它們尚未在同行評審的出版物上發表，也未必像 III 期數據那樣在全體會議上進行展示。但總的來說，我認為這些數據對產品而言非常重要，並且有可能成為產品差異化的關鍵數據。

Your next question comes from the line of Carter Gould with UBS.

你的下一個問題來自瑞銀集團的卡特古爾德。

Sean, I'll stick with the pipeline theme. On the BLINCYTO studies you referenced DLBCL when do you think those data might be presented? Are those at the registrational? And on CNP520, is there any interim built into that Alzheimer's study?

肖恩，我還是堅持管道這個主題。您提到的BLINCYTO研究中的DLBCL，您認為這些數據何時會公佈？那些是在登記處嗎？關於 CNP520，這項阿茲海默症研究是否包含任何中期研究？

Yes, so the BLINCYTO studies are just enrolling now, so it's a little bit hard to project when we would be presenting data from them. That depends, of course, on a number of factors in terms of enrollment rate and when we might hit certain milestones with respect to interim analysis, and so on. But the program is progressing on plan, and we're seeing a lot of enthusiasm in the marketplace for the -- in clinical trial investigator space, I should say -- for the program. And then, with respect to the 520 program, there are some futility analyses built into the Alzheimer's study, which are designed to kind of cut losses if we weren't seeing some kind of an effect. And I believe there may be also an early stopping efficacy interim late in the trial, though I'd have to go back and look at the protocol to be sure about that.

是的，BLINCYTO 研究目前才剛開始招募受試者，所以很難預測我們何時會公佈相關數據。當然，這取決於入學率等諸多因素，以及我們何時能夠達到中期分析的某些里程碑等等。但該計劃正在按計劃推進，我們看到市場對該計劃——應該說是臨床試驗研究人員領域——充滿了熱情。此外，關於 520 計劃，阿茲海默症研究中內建了一些無效性分析，其目的是在未觀察到任何效果時減少損失。而我認為試驗後期可能還會有一個提前終止療效中期評估，不過我需要回去查看試驗方案才能確定。

Sean, not everybody might be familiar with the 520, so you might just remind them why we're (inaudible)

肖恩，可能不是每個人都熟悉520，所以你或許可以提醒他們我們為什麼（聽不清楚）

Yes, so you might remember that this was highlighted in the Wall Street Journal the other day. We -- Novartis and Amgen I think, had come convergently to the opinion that we have extremely high confidence in the target itself, in large part because of the genetic validation work that was done on this target at deCODE. And so the question is really a question of when to intervene. And what we're doing in this study is enriching for a population who, based on their APOE genotype and age, are very highly predisposed to converting from a normal cognitive capability to a minimally impaired cognitive capability. So we're going earlier than anyone else has done to date. This actually may be what's required to demonstrate the disease modifying effect. So the molecule itself is a very high-quality small molecule BACE inhibitor that has been demonstrated to drop a-beta levels dramatically in CSF and all that good stuff. And the main issue strategically is to go in a little bit earlier in this population. And while this is a genetically defined population, about 60% of patients who actually develop Alzheimer's have these -- one of these predisposing alleles. So it's not some tiny little population that's genetically defined.

是的，你可能還記得前幾天《華爾街日報》重點報導這件事。我認為，諾華和安進都一致認為，我們對該靶點本身非常有信心，這很大程度上是因為 deCODE 對該靶點進行了基因驗證工作。所以問題其實是何時介入的問題。我們在這項研究中所做的，是為了豐富那些根據其 APOE 基因型和年齡，極易從正常認知能力轉變為輕微認知能力受損的人群。所以，我們比迄今為止任何人都走得更早。這或許正是證明疾病改善作用所必需的。所以該分子本身是一種非常高品質的小分子 BACE 抑制劑，已被證明能顯著降低腦脊髓液中的 α-β 水平等等。從策略角度來看，主要問題在於要更早進入這個人群。雖然這是一個基因定義的群體，但大約 60% 的阿茲海默症患者都攜帶這些易感基因之一。所以這不是一個由基因定義的小群體。

Your next question comes from the line of Geoff Meacham with Barclays.

你的下一個問題來自巴克萊銀行的傑夫‧米查姆。

One for Tony or Sean. So in contrast to Repatha, you haven't had a lot of payer pushback on Prolia. So are there payer or pricing lessons to be learned when you think about the romo launch in July and its combination with Prolia?

給托尼或肖恩。因此，與 Repatha 相比，Prolia 並沒有遇到太多支付方的阻力。那麼，在考慮 7 月 romo 的推出及其與 Prolia 的結合時，我們能否從支付方或定價方面吸取一些經驗教訓呢？

Let me take that one, Jeff. The major difference, probably, between the 2 is that the majority of Prolia sales are Part B, so it's a buy-in-bulk model whereas Repatha is predominantly a Part D or a retail product itself. I think it's all around the value proposition. And we go back again to the day we presented at the ACC to just reconfirm that the present net price of Repatha in the marketplace is well within the range of the value proposition or the value-based pricing, in fact, for this particular product. So I think the 2 things are different. There was a lot of speculation upfront about how the PCSK9s could cost the market $150 billion, or whatever it was which resulted in some silly actions, I think, with all due respect. The drugs continue to show real good value. We're happy to stand up and discuss it anywhere and (inaudible) at the moment is how you change utilization management criteria, if nothing else.

傑夫，那件事交給我吧。兩者之間的主要區別可能在於，Prolia 的大部分銷售額來自 B 部分，因此它是一種批量購買模式，而 Repatha 主要屬於 D 部分或本身就是零售產品。我認為關鍵在於價值主張。我們再次回到我們在 ACC 會議上發表報告的那天，再次確認 Repatha 目前在市場上的淨價完全符合該產品的價值主張或基於價值的定價範圍。所以我認為這兩件事是不同的。之前有很多關於 PCSK9 可能對市場造成 1500 億美元損失的猜測，或者不管損失多少，這導致了一些愚蠢的舉動，恕我直言。這些藥物持續展現出極佳的價值。我們很樂意隨時隨地站出來討論這個問題，（聽不清楚）目前最重要的是如何改變使用率管理標準，至少在其他方面是如此。

And your next question comes from the line of Chris Raymond with Raymond James.

你的下一個問題來自克里斯·雷蒙德和雷蒙德·詹姆斯樂隊。

So just a broader question on the biologics market structure and maybe as it relates to your biosimilar business. So we were reading white paper that, I think, you guys put out recently in the biosimilar market. I think you guys highlight a real problem that even under a hypothetical scenario, I think your paper talked about how where a biosimilar is priced at say a 25% discount to the innovator, you still have a patient copay that's still higher than the innovative drug. I think in your paper, it said like almost 40% higher under Medicare Part D. So just curious, you guys seem as close as anyone to policymakers and directions to where this may go. And I know you've devoted a great deal of time and energy towards your biosimilar business. I assume that there's an expectation here that some of these disincentives will go away. Can you maybe talk in broad terms how you think that might play out?

所以，我想問一個關於生物製劑市場結構更廣泛的問題，以及這可能與貴公司的生物相似藥業務相關的問題。所以我們正在閱讀一份白皮書，我想應該是你們最近發布的關於生物相似藥市場的白皮書。我認為你們指出了一個真正的問題，即使在假設的情況下，你們的論文也談到，即使生物相似藥的價格比原廠藥低 25%，患者的自付費用仍然會高於原研藥。我記得你們的論文裡提到，在聯邦醫療保險D部分（Medicare Part D）下，費用大約高出40%。所以我就想問，你們似乎是最了解政策制定者，也最能把握政策走向的人。我知道您為生物相似藥業務投入了大量的時間和精力。我估計大家期望其中一些不利因素會消失。您能否大致談談您認為這件事可能會如何發展？

Tony, why don't you go ahead and take the...

東尼，你為什麼不去拿…

Sure. One, I don't remember us putting out a white paper, so I just want to make sure that we're not being given authorship of something we didn't write, because I'm unaware of Amgen putting out a white paper. We have said historically in the past that we believe that the biosimilar market will move much like a branded generic market, that the pricing in the beginning will be cautious, that the people will come to market and those who actually use biosimilars will be looking for a combination of quality, continuity of quality, continuity of supply and the reputations of the organizations coming to market. We believe that as Amgen, we have a lot of good reputation. We have a 30-year history of never shorting a patient, of having quality product consistently on the marketplace. As we've gone through the process of actually developing these biosimilars ourselves, we've realized how tough it is to actually bring these drugs to market or how to develop them. We spend time with regulators around the world making sure they understand what good looks like. So the rules and regulations are aligned with what we are doing. There is some debate in the U.S. around linked J-codes between the brand versus the biosimilar. I think those are still being debated at the moment. But until then, it's an unlinked J-code which means reimbursement of copays are different. There's a lot happening in the marketplace and how that could change, I can't speculate now.

當然。第一，我不記得我們發布過白皮書，所以我只是想確認一下，我們是否被賦予了我們並未撰寫的內容的署名權，因為我不知道安進公司發布過白皮書。我們過去曾說過，我們認為生物相似藥市場的發展趨勢將與品牌仿製藥市場非常相似，初期定價會比較謹慎，人們會進入市場，而真正使用生物相似藥的人會尋求質量、質量的持續性、供應的持續性以及進入市場的組織的聲譽等因素的綜合考慮。我們相信，作為安進公司，我們擁有良好的聲譽。30年來，我們從未讓任何一位患者失望，並始終向市場提供優質產品。在我們實際開發這些生物相似藥的過程中，我們意識到將這些藥物推向市場或如何開發它們是多麼困難。我們花時間與世界各地的監管機構溝通，確保他們了解什麼是好的標準。所以規章制度與我們正在做的事情是一致的。美國對於品牌藥與生物相似藥之間的關聯 J 代碼存在一些爭議。我認為這些問題目前仍在爭論中。但在此之前，它是一個未關聯的 J 代碼，這意味著自付費用的報銷方式有所不同。市場瞬息萬變，未來走向如何，我現在無法預測。

Derek, as it's going on 6:30 on the East Coast, let's take 2 last questions.

德里克，現在東海岸已經是 6:30 了，我們來回答最後兩個問題。

Absolutely. And your next question comes from the line of Eun Yang with Jefferies.

絕對地。你的下一個問題來自楊恩與傑富瑞的合作。

A question for Sean. In your collaboration with Arrowhead on RNAi therapies targeting cardiovascular diseases, what's your view on potential safety issues that may be related to RNAi-based therapies, and when do you expect to move into clinic?

問肖恩一個問題。在您與 Arrowhead 合作開發針對心血管疾病的 RNAi 療法的過程中，您如何看待可能與 RNAi 療法相關的潛在安全問題？您預計何時進入臨床階段？

Yes, I think that the siRNA technologies right now look good enough that in the case where the only way one can drug a target appears to be siRNA-based innovation, it's a reasonable thing to pursue. And so that's what we're doing, for example, for LP(a), where we don't feel there's any other way to drug the target. It's not a derisked platform at this point, and there obviously are concerns. And I think that regulators are going to be very cautious in approving products early on that are based on that kind of -- on this kind of novel platform unless, of course, it's in a setting where there's very high unmet need and no other kind of option. So we're exploring siRNA largely in settings in which the drug can't be -- the target can't be interdicted in other ways and also where we feel that it would be a -- that the therapy would be unique in its ability to address that target. So LP(a) represents an example like that. We have other targets that we feel are potentially that way. And so at this point, we're moving that ahead. The program is really still in a preclinical stage but it is moving very, very rapidly. The collaboration has been great. But I can't really give specific timelines of when it would be in the clinic.

是的，我認為目前的siRNA技術看起來足夠好，如果唯一能針對特定標靶進行藥物治療的方法似乎是基於siRNA的創新，那麼追求這種技術是合理的。因此，例如對於 LP(a)，我們就是這樣做的，因為我們覺得沒有其他方法可以對目標進行藥物治療。目前它還不是一個風險已消除的平台，顯然存在一些問題。我認為，監管機構在早期批准基於這種新型平台的產品時會非常謹慎，除非是在存在高度未滿足的需求且沒有其他選擇的情況下。因此，我們主要在藥物無法以其他方式阻斷標靶的情況下探索 siRNA，我們認為這種療法在解決該標靶方面具有獨特性。所以 LP(a) 代表了這樣一個例子。我們還有其他一些目標，我們認為它們也可能屬於這種情況。所以目前，我們正在推進這項工作。該計畫目前仍處於臨床前階段，但進展非常非常迅速。合作非常愉快。但我無法給出具體的診所就診時間。

Your next question comes from the line of Salim Syed.

你的下一個問題出自薩利姆·賽義德的詩句。

Just one question on romo maybe for Sean or for Tony. The non-vertebral data, guys, how are you thinking about that in terms of uptake? And then also, will we be getting that non-vertebral data in the press release either in the qualitative form or quantitative form when we get the top line?

關於羅莫，我只有一個問題想問肖恩或東尼。各位，關於非脊椎數據，你們是如何看待其吸收情況的？另外，當我們獲得主要數據時，新聞稿中是否會以定性或定量形式提供非脊椎資料？

Yes, so what I would say is that having evidence of non-vertebral fracture impact is important for these kind of therapeutics. Of course, the most important endpoint for physicians, payers and patients is clinical fracture, which is the symptomatic vertebral fractures which can be very profoundly impactful to patients' quality of life as well as the long-bone fractures or non-vertebral fractures. And there, we've seen good results. And that's one of the co-primary endpoints for ARCH as well. And I think that it is something that is an important variable. In the end, things like hip fracture are the real dreaded complications of osteoporosis. So having a sense from the aggregate data for a molecule that there can be protection at sites like the hip is important. And that's why we're anticipating ARCH keenly as it's coming very soon. I can't comment on what we exactly will decide to disclose in a press release. We are always focused on very complex embargo requirements by both the society clinical presentation venues as well as the journals that we're trying to publish in, and this can be quite an elaborate dance to figure out what we can put into our press releases in that setting.

是的，所以我想說的是，對於這類治療方法而言，有證據表明存在非椎體骨折的影響非常重要。當然，對於醫生、支付方和患者而言，最重要的終點是臨床骨折，即有症狀的椎體骨折，它會對患者的生活品質產生非常深遠的影響，以及長骨骨折或非椎體骨折。而且，我們在那裡看到了良好的效果。這也是 ARCH 的主要終點之一。我認為這是一個重要的變數。歸根究底，髖部骨折等才是骨質疏鬆症真正令人恐懼的併發症。因此，從分子的整體資料中了解髖部等部位是否可以得到保護是很重要的。正因如此，我們才對即將到來的 ARCH 充滿期待。我無法評論我們最終會在新聞稿中披露哪些內容。我們始終關注協會臨床展示場所和我們試圖發表文章的期刊非常複雜的禁令要求，而弄清楚在這種情況下我們可以在新聞稿中發布什麼內容，可能需要相當複雜的周旋。

Thank you all for your questions and for your time. We appreciate it. Maybe just a quick -- couple of quick thoughts from me, and then we'll let you get back to work. First, as you heard in our discussion, we're pleased with the volume growth, particularly from our newer products in the quarter. Clearly, there was some noise in the first quarter around Enbrel and the trends. But as you heard us say, we think the long-term trends for Enbrel are on track despite that noise in the marketplace in the first quarter. And again, lastly, we think we positioned the company well. And as a group here, we're excited about the future, given the long-term growth opportunities that we see for Amgen. So thanks for your interest. We look forward to talking to you on the second quarter call.

感謝大家的提問和抽出時間。我們非常感謝。也許我只需要簡單說幾句，然後就讓你繼續工作了。首先，正如您在我們討論中聽到的那樣，我們對銷售成長感到滿意，特別是本季新產品的銷售成長。顯然，第一季圍繞恩利（Enbrel）及其發展趨勢存在一些爭議。但正如我們所說，儘管第一季市場出現了一些波動，但我們認為 Enbrel 的長期趨勢仍然在按計劃進行。最後，我們認為我們已經為公司做好了定位。我們團隊對未來感到興奮，因為我們看到了安進的長期成長機會。感謝您的關注。我們期待在第二季電話會議上與您交流。

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

今天的電話會議到此結束。您現在可以斷開連線了。