美國安進 (AMGN) 2016 Q4 法說會逐字稿

My name is Frederick and I'll be your conference facilitator today for Amgen's fourth quarter 2016 financial results conference call.

我叫做弗雷德里克，今天我將擔任安進公司 2016 年第四季財務業績電話會議的主持人。

(Operator Instructions)

（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。

Thank you, Frederick. Good afternoon, everybody. I would like to welcome you to our conference call to review our operating performance for the fourth quarter and full year 2016. So before we start, I would like to welcome back Mark Schoenebaum of ISI Evercore, who has returned from his leave.

謝謝你，弗雷德里克。大家下午好。歡迎各位參加我們的電話會議，我們將回顧 2016 年第四季和全年的營運表現。那麼在正式開始之前，我想歡迎 ISI Evercore 的 Mark Schoenebaum 結束休假回歸。

I would also like to acknowledge those who are relatively new in their coverage of Amgen, including Salim Syed of Mizuho Securities and Leah Cann of Oppenheimer. Welcome. Each of us look forward to working with you.

我還要感謝那些對安進公司進行報告的相對較新的人士，包括瑞穗證券的 Salim Syed 和奧本海默公司的 Leah Cann。歡迎。我們每個人都期待與您合作。

So let's go ahead and get started, as we have a lot of ground to cover today. I'm sure you've seen our press release by now and we are particularly pleased to report that our Repatha FOURIER Outcome study has met its primary composite endpoint and the key secondary composite endpoint with no new safety findings.

那麼，讓我們開始吧，因為今天我們要學習的內容很多。我相信您現在已經看到了我們的新聞稿，我們特別高興地報告，我們的 Repatha FOURIER 結果研究已達到其主要複合終點和關鍵次要複合終點，且沒有發現新的安全性問題。

In order to ensure presentation of this important data at the American College of Cardiology Meeting in March, unfortunately, we will not be able to provide additional details at this time above and beyond what's in the press release. We will host an Investor event on March 17, and look forward to seeing you in Washington, DC.

為了確保在 3 月的美國心臟學會會議上展示這些重要數據，很遺憾，目前我們無法提供新聞稿以外的更多細節。我們將於3月17日舉辦投資者活動，期待在華盛頓特區與您相見。

So leading the call today will be our Chairman and CEO, Bob Bradway, who will provide a strategic report on our performance in 2016 and outlook for 2017. Following Bob, our CFO, Dave Meline, will review our Q4 and full year results and provide details on assumptions embedded in our guidance for 2017.

今天主持電話會議的將是我們董事長兼執行長鮑伯‧布拉德韋，他將就我們 2016 年的業績和 2017 年的展望提供一份策略報告。在鮑伯之後，我們的財務長戴夫梅林將回顧我們第四季和全年的業績，並詳細介紹我們 2017 年業績指引中蘊含的假設。

Our Head of Global Commercial Operations, Tony Hooper, will then discuss our product performance during the quarter, followed by a Head of R&D, Sean Harper, who will provide a pipeline update. As in the past, 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.

接下來，我們的全球商業營運主管 Tony Hooper 將討論本季我們的產品表現，隨後研發主管 Sean Harper 將提供產品線更新資訊。和以往一樣，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，連結也已透過電子郵件單獨發送給您。

We plan on using non-GAAP financial measures in today's presentation to provide information which may be useful to 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。

So just a reminder that some of the statements made during the course of our presentation today are forward-looking statements and our 2015 10-K and subsequent filings identify factors that could cause our actual results to differ materially. So with that, I would like to turn the call over to Bob.

因此，在此提醒大家，我們今天在演講過程中所作的一些陳述是前瞻性陳述，我們在 2015 年的 10-K 表格及後續文件中列出了可能導致我們實際結果與前瞻性陳述有重大差異的因素。那麼，接下來我將把電話交給鮑伯。

Okay. Thank you for joining our call. I want to start with the exciting news that we have positive results from our Repatha cardiovascular outcomes trial. In terms of efficacy, the trial met its primary composite and secondary composite endpoints and importantly, in terms of safety, there were no new findings in the trial.

好的。感謝您參加我們的電話會議。首先我想宣布一個令人振奮的消息：我們的 Repatha 心血管療效試驗取得了正面成果。就療效而言，該試驗達到了主要複合終點和次要複合終點；更重要的是，就安全性而言，該試驗沒有發現任何新結果。

This is obviously an important result for us and for the field as it clearly validates the outcomes benefit of PCSK9 inhibition in cardiovascular disease. Cardiovascular disease is the most costly disease for society today, and in the absence of new therapies, to reduce the risk of cardiovascular events for the millions of patients at high risk in the US and around the world, the burden of this disease is set to rapidly rise.

這顯然對我們和該領域來說都是一個重要的結果，因為它清楚地驗證了 PCSK9 抑制劑在心血管疾病治療中的療效。心血管疾病是當今社會最昂貴的疾病，由於缺乏新的療法來降低美國和世界各地數百萬高風險患者發生心血管事件的風險，這種疾病的負擔勢必會迅速增加。

This is why we've been of so determined to advance Repatha as an innovative treatment option for those people whose LDL levels and cardiovascular risks aren't well managed by other available therapies.

這就是為什麼我們一直決心推進 Repatha 作為一種創新治療方案，用於治療那些 LDL 水平和心血管風險無法透過其他現有療法得到良好控制的人。

Today's announcement is a culmination of many years of hard work and investment by Amgen, our scientists and collaborators around the world and I'd like to thank all of those, including the patients in the trial for making this possible. We look forward to sharing the data from this rigorous 27,500 patient outcome study at the American College of Cardiology Meeting in mid-March and to using the data from our entire comprehensive clinical development program for this molecule to prove the value of this innovative therapy to the healthcare system.

今天的公告是安進公司、我們的科學家和世界各地的合作者多年來辛勤工作和投資的成果，我要感謝所有人，包括參與試驗的患者，是他們讓這一切成為可能。我們期待在 3 月中旬的美國心臟病學會會議上分享這項嚴謹的 27,500 名患者結果研究的數據，並利用我們針對該分子開展的整個綜合臨床開發項目的數據，向醫療保健系統證明這種創新療法的價值。

As our investors know, investment in innovation and a stronger conviction to use information available from human genetics to guide that investment are at the core of our strategy. Today's results for Repatha are encouraging on both dimensions of our strategy and also underscore our confidence in our ability to drive our long-term growth.

正如我們的投資者所知，對創新進行投資，並更加堅定地利用人類遺傳學資訊來指導投資，是我們策略的核心。Repatha 現今的表現在策略的兩方面都令人鼓舞，同時也突顯了我們對推動長期成長能力的信心。

Now let me turn to update you on the substantial progress we made on our priorities for 2016 with continued solid execution across the business. Our results for the year were strong, with earnings per share growing at twice the rate of revenues, as reflected in our 12% growth of EPS on a non-GAAP basis and revenue growth of 6%.

現在讓我向大家報告我們在 2016 年各項優先事項上取得的實質進展，以及公司各部門持續穩健的執行情況。我們今年的業績表現強勁，每股盈餘成長速度是營收成長速度的兩倍，這體現在我們以非GAAP準則計算的每股盈餘成長了12%，營收成長了6%。

Our commitment to reshaping the expense base of the business delivered results once more in 2016, with a decrease in operating expenses on a growing business and a 4% improvement in our operating margin on a non-GAAP basis to 52%. Through our transformation efforts, we've been able to reshape the business while continuing to invest for long-term growth.

2016 年，我們致力於重塑業務支出基礎，並再次取得了成果，在業務成長的情況下，營運費用有所下降，非 GAAP 營運利潤率提高了 4%，達到 52%。透過轉型努力，我們得以重塑業務，同時繼續投資以實現長期成長。

International expansion is an important element of our long-term growth plan. Consistent with that aspiration, we continued to roll out our launches of new medicines internationally with some 94 new product stroke country launches in 2016.

國際擴張是我們長期成長計畫的重要組成部分。秉承這一願景，我們繼續在國際範圍內推出新藥，2016 年在約 94 個中風國家推出了新產品。

Our pipeline is core to our long-term growth aspiration as well and here, too, we made real progress in 2016, as three new late-stage products rapidly approached the market, including Parsabiv in kidney disease, which is already approved in Europe and we expect soon to be approved in the US; EVENITY, our romosozumab antibody in bone health; and Erenumab, our CGRP antibody for migraine.

我們的研發管線也是我們長期成長願景的核心，而且我們在 2016 年也取得了真正的進展，三款新的後期產品迅速接近市場，包括用於治療腎病的 Parsabiv（已在歐洲獲得批准，我們預計很快將在美國獲得批准）；用於治療骨骼健康的 romosozumab 抗體 EVENITY；以及用於治療偏頭痛的 CG mRP 抗體。

We believe our biosimilars portfolio will also be a long-term growth driver and here, too, we continue to invest in our portfolio of molecules and achieved an approval of AMJEVITA, a regulatory filing for our biosimilar to Avastin and a successful pivotal study for our biosimilar to Herceptin.

我們相信，我們的生物相似藥產品組合也將成為長期成長的驅動力，我們也將繼續投資於我們的分子產品組合，並已獲得 AMJEVITA 的批准，提交了我們針對 Avastin 的生物類似藥的監管申請，並成功完成了我們針對 Herceptin 的生物類似藥的關鍵性研究。

We've said for some time that one of the characteristics of our business is its strong cash flows. This year, we generated nearly $10 billion of free cash flow, or an 8% cash flow yield. This enables us to return significant capital to our shareholders and to invest externally in innovation, which we did once again this year. Consistent with our confidence in our outlook for long-term growth, we once more raised our dividend, this time by 15%.

我們一直以來都強調，我們業務的特點之一就是強勁的現金流。今年，我們產生了近 100 億美元的自由現金流，現金流收益率為 8%。這使我們能夠向股東返還大量資金，並進行外部創新投資，而我們今年再次這樣做了。出於對長期成長前景的信心，我們再次提高了股息，這次提高了 15%。

As I mentioned before, we're focused on long-term growth. In 2014, we provided five-year financial commitments through 2018. We've just passed the three-year mark and I'm pleased with our tangible progress against those commitments, and we're on track to meet or exceed them. We will likely face headwinds in 2017 as declines in our mature brands will begin to offset volume growth from our more recently launched products.

正如我之前提到的，我們專注於長期成長。2014年，我們提供了截至2018年的五年財務承諾。我們剛剛過了三年期限，我對我們在履行這些承諾方面取得的實際進展感到滿意，我們有望達到甚至超過這些目標。2017年，我們可能會面臨一些不利因素，因為成熟品牌的銷售下滑將開始抵銷我們新推出的產品的銷售成長。

This is reflected in our 2017 guidance, which David will discuss further. It's important to note that we began our transformation efforts here several years ago in anticipation of the competitive headwinds we expect to face. Operating leverage from the changes we've made enable us to drive earnings growth in the near term while our longer-term investments have laid the foundation for growth beyond this period.

這一點已體現在我們的 2017 年指導方針中，David 將對此進行更詳細的討論。值得注意的是，為了因應我們預期將面臨的競爭逆風，我們幾年前就開始了轉型工作。我們透過所採取的變革所帶來的經營槓桿效應，使我們能夠在短期內推動獲利成長，而我們的長期投資則為未來一段時間的成長奠定了基礎。

The elements necessary to drive that long-term growth are clearly coming into focus, with our recent launch of six new therapies including Repatha and KYPROLIS and the three we expect to launch in the near future, as well as the emergence of our biosimilar portfolio.

推動長期成長的必要因素正逐漸清晰，我們最近推出了六種新療法，包括 Repatha 和 KYPROLIS，以及我們預計在不久的將來推出的三種療法，此外，我們的生物相似藥產品組合也正在湧現。

Shifting focus to Washington, I thought perhaps I should say a few words following our meeting with President Trump and his administration earlier this week. First, I would reiterate my appreciation for the President and his administration's interest in our industry. He was very clear about his desire to promote innovation on behalf of patients, economic growth, and job creation.

把目光轉向華盛頓，我想在本週稍早與川普總統及其政府會面後，或許應該說幾句。首先，我要再次感謝總統及其政府對我們產業的關注。他非常明確地表達了自己希望為了病人、經濟成長和創造就業機會而促進創新的願望。

Second, the President and his team recognized the leading role that the United States has played in the field of biotechnology and we share their desire to strengthen the environment for employees and employers in this sector. Biotech jobs are highly skilled, desirable jobs and there's a global competition for them.

其次，總統及其團隊認可了美國在生技領域的領導作用，我們也和他們一樣希望加強該產業員工和雇主的就業環境。生技類工作是高技能、高需求的工作，而且全球競爭都很激烈。

We've long supported corporate tax reform as a way to level the playing field with our ex-US competitors and we look forward to being part of the policy discussions with the new administration around this area as well as regulatory reform, intellectual property protection and trade policy. I think this administration expects to deliver real progress in each of those areas for our industry.

我們一直支持企業稅制改革，以此作為與美國以外的競爭對手公平競爭的一種方式。我們期待與新政府就此領域以及監管改革、智慧財產權保護和貿易政策進行政策討論。我認為本屆政府期望在這些領域為我們產業帶來真正的進步。

And now on the topic of drug pricing, the President was also clear, as he was throughout his campaign, about the need for us to find ways to bring down the cost of drugs for citizens in the US. We want and expect to work with the President and the administration to be part of the solution in that effort.

至於藥品定價問題，總統也像他在整個競選期間一樣，明確表示我們需要找到降低美國公民藥品價格的方法。我們希望並期待與總統和政府合作，成為解決這個問題的一部分。

Participation with the administration and Congress, we will seek to advance changes that enable more Americans to have affordable access to life savings and cost-effective medicines. Now let's turn to David who will review our financial performance. David?

我們將與政府和國會合作，努力推動各項改革，使更多美國人能夠負擔得起救命的醫療救助和經濟有效的藥品。現在讓我們請大衛來回顧一下我們的財務表現。大衛？

Okay. Thanks, Bob. Turning to the fourth quarter financial results on page 6 of the slide deck, revenue at $6 billion grew 8% year over year. This quarter, we saw steady product sales performance driven by net selling price and unit demand growth versus last year. Other revenues at $302 million increased $95 million versus the fourth quarter of 2015.

好的。謝謝你，鮑伯。翻到投影片第 6 頁，可以看到第四季的財務業績，營收為 60 億美元，年增 8%。本季度，受淨售價和單位需求較去年同期成長的推動，產品銷售業績保持穩定。其他收入為 3.02 億美元，比 2015 年第四季增加了 9,500 萬美元。

Other revenue benefited primarily from milestone payments, notably a milestone received related to the outlicensing of AMG 139, consistent with our focus on optimizing our portfolio of pipeline assets. Changes in foreign exchange had less than a 1% negative impact to total revenue and product sales in the quarter on a year-over-year basis.

其他收入主要受益於里程碑付款，特別是與 AMG 139 對外授權相關的里程碑付款，這與我們專注於優化管道資產組合的理念相一致。外匯變動對本季總營收和產品銷售額的年比負面影響不到 1%。

Non-GAAP operating income at $2.9 billion grew 21% from prior year. Non-GAAP operating margin improved by over 6 points to 50.5% for the quarter, reflecting continued revenue performance, favorable expense impacts from our transformation initiatives across all operating expense categories, and the expiry of the Enbrel residual royalty payment on October 31.

非GAAP營業收入為29億美元，較上年成長21%。本季非GAAP營業利潤率提高了6個百分點以上，達到50.5%，這反映了持續的收入表現、我們轉型計劃在所有營運費用類別中帶來的有利費用影響，以及Enbrel剩餘特許權使用費於10月31日到期。

On a non-GAAP basis, cost of sales as a percent of product sales improved by 1 point to 13.3%, driven by manufacturing efficiencies. Research and development expenses at $1.06 billion were flat year over year. SG&A expenses decreased 4% on a year-over-year basis, primarily due to the expiry of the Enbrel residual royalty payment. In total, non-GAAP operating expenses decreased 2% year over year.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比提高了1個百分點，達到13.3%，這主要得益於生產效率的提升。研發費用為10.6億美元，與前一年持平。銷售、一般及行政費用較去年同期下降 4%，主要原因是 Enbrel 剩餘特許權使用費到期。整體而言，非GAAP營運費用較去年同期下降2%。

Other income and expenses were a net $202 million expense in Q4. This is unfavorable by $82 million on a year-over-year basis. This year-over-year unfavorability was primarily due to higher interest expense due to higher net debt levels -- sorry, higher debt levels as well as losses from investment portfolio rebalancing in the fourth quarter of this year.

第四季其他收入和支出淨額為 2.02 億美元。與上年同期相比，這不利了 8,200 萬美元。與去年同期相比，這一不利因素主要是由於淨債務水平上升導致利息支出增加——抱歉，是債務水平上升，以及今年第四季度投資組合再平衡造成的損失。

The non-GAAP tax rate was 18.7% for the quarter, a 7.1 point increase versus Q4 of 2015. This increase reflects unfavorable changes in the geographic mix of earnings this year as well as the realization of the full-year benefit of the 2015 federal R&D tax credit in the fourth quarter of 2015.

本季非GAAP稅率為18.7%，比2015年第四季成長了7.1個百分點。這一增長反映了今年收益地域構成不利的變化，以及 2015 年第四季度實現 2015 年聯邦研發稅收抵免的全年收益。

Non-GAAP net income increased 9% and non-GAAP earnings per share increased 11% year over year for the fourth quarter. Please find a summary of our 2016 full-year results on page 7 of the presentation. Our 2016 full-year revenues grew 6% to $23 billion and non-GAAP earnings per share grew 12% to $11.65 per share.

第四季度，非GAAP淨利年增9%，非GAAP每股盈餘較去年同期成長11%。請參閱簡報第 7 頁，以了解我們 2016 年全年業績的摘要。2016 年全年營收成長 6% 至 230 億美元，非 GAAP 每股盈餘成長 12% 至每股 11.65 美元。

For the full year, non-GAAP operating income at $11.4 billion grew 14% from prior year, based on the combination of solid revenue growth and a year-over-year decline in operating expenses. Non-GAAP operating margin improved by over 4 points to 52.3% for the year, demonstrating our commitment to improve the profitability of the business as we continued to realize the benefits from our ongoing transformation initiatives.

全年非GAAP營業收入為114億美元，比上年增長14%，這得益於穩健的收入增長和營業費用同比下降。本年度非GAAP營業利潤率提高了4個百分點以上，達到52.3%，這表明我們致力於提高業務盈利能力，同時我們也繼續從持續的轉型舉措中獲益。

On a non-GAAP basis, cost of sales as a percent of product sales improved by 1.2 points to 13.3%, driven by manufacturing efficiencies. This decrease is a direct result of our continuing efforts to streamline our manufacturing processes, increase utilization of our factories, and maintain our position as a leader in the field of biologic drug manufacturing.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比提高了1.2個百分點，達到13.3%，這主要得益於生產效率的提高。這一下降是我們不斷努力簡化生產流程、提高工廠利用率以及保持我們在生物藥物製造領域的領先地位的直接結果。

Research and development decreased 4% as increased new business development activities were more than offset by lower spending required to support certain later stage clinical programs, as well as transformation and process improvement efforts. SG&A expenses were up 5%, primarily due to launch product expense increases, partially offset by the benefits of our transformation efforts as well as the expiration of the Enbrel residual royalty.

由於新業務開發活動的增加被支持某些後期臨床項目以及轉型和流程改善工作所需的支出減少所抵消，研發支出減少了 4%。銷售、一般及行政費用增加了 5%，主要是由於產品上市費用增加，部分被轉型努力帶來的收益以及 Enbrel 剩餘特許權使用費的到期所抵消。

In total, non-GAAP operating expenses decreased 1% year over year to $11.5 billion, reflecting continued benefits from our transformation and process improvement efforts. Through 2016, operating expenses have decreased by approximately $200 million versus the 2013 levels, while absorbing significant investments in new product launches, advancing our new biosimilar business, and building out our global presence.

非GAAP營運支出總額較去年同期下降1%至115億美元，反映出我們轉型和流程改善工作持續帶來的效益。截至 2016 年，營運費用較 2013 年減少了約 2 億美元，同時吸收了大量投資，用於新產品上市、推進新的生物相似藥業務以及拓展全球業務。

We remain on track to our 2018 commitments. To date, we have realized approximately $1.2 billion of transformation savings, well on our way to achieving our 2018 commitment of $1.5 billion. Other income and expenses were unfavorable by $139 million on a year-over-year basis due to lower investment gains realized in 2016 and higher interest expense due to higher debt balances, offset partially by higher interest income due to higher cash balances.

我們仍按計劃履行2018年的承諾。迄今為止，我們已實現約 12 億美元的轉型節約，正朝著實現 2018 年 15 億美元的承諾穩步邁進。由於 2016 年實現的投資收益減少以及債務餘額增加導致利息支出增加，其他收入和支出同比減少了 1.39 億美元，但現金餘額增加導致利息收入增加部分抵消了這些不利影響。

The non-GAAP tax rate was 18.8%, up 2 points versus 2015. The year-over-year increase was primarily due to unfavorable changes in the geographic mix of earnings, offset partially by the adoption of Accounting Standards Update 2016-09 earlier this year.

非GAAP稅率為18.8%，較2015年上升了2個百分點。年比增幅主要是由於獲利地域組成發生不利變化，但部分被今年稍早採用的會計準則更新 2016-09 所抵銷。

Turning next to cash flow and the balance sheet on page 8. For the full year 2016, Amgen continued to demonstrate strong and durable cash flow generation with $9.6 billion in free cash flow versus $9.1 billion last year. This increase was primarily driven by higher profitability. Cash and investments increased to $38.1 billion.

接下來請看第 8 頁的現金流量表和資產負債表。 2016 年全年，安進持續展現出強勁且持久的現金流生成能力，自由現金流為 96 億美元，而去年為 91 億美元。這一增長主要是由更高的盈利能力推動的。現金及投資增至381億美元。

This balance included $2 billion in the US and $36.1 billion outside the US. Total debt outstanding increased to $34.6 billion and carries a weighted average interest rate of 3.8% and an average maturity of 13 years. In 2016, we deployed $3 billion to repurchase 19.7 million shares at an average of $154 per share.

這項餘額包括美國境內的 20 億美元和美國境外的 361 億美元。未償債務總額增至 346 億美元，加權平均利率為 3.8%，平均年期為 13 年。2016 年，我們投入 30 億美元回購了 1,970 萬股股票，平均每股價格為 154 美元。

At the end of 2016, we had $4.1 billion remaining on our share repurchase authorization. Additionally for 2016, we increased our dividend per share by 27% to $1 per quarter, with payments totaling $3 billion. Based on our confidence in the future outlook for the enterprise and our continued commitment to our capital allocation strategy, we also announced a 15% increase to the dividend to $1.15 per share in the first quarter of 2017.

截至 2016 年底，我們的股票回購授權額度還剩 41 億美元。此外，2016 年，我們將每股股利提高了 27%，達到每季 1 美元，支付總額為 30 億美元。基於我們對企業未來前景的信心以及我們對資本配置策略的持續承諾，我們也宣佈在 2017 年第一季將股利提高 15%，至每股 1.15 美元。

Turning to the outlook for the business for 2017 on page 9. 2017 will be an important year for Amgen as we continue to progress towards achievement of our long-term commitments. We've reshaped the business to deliver top tier margin performance while continuing to invest for the long-term growth of the business.

接下來，我們將在第 9 頁展望 2017 年的業務前景。 2017 年對安進來說將是重要的一年，我們將繼續朝著實現我們的長期承諾邁進。我們對業務進行了重組，以實現一流的利潤率，同時繼續投資於業務的長期成長。

As we enter 2017, there are several key assumptions embedded in our outlook that I would like to take a moment to share. First, our revenue guidance range for 2017 includes continued positive momentum from our growth brands and recent product launches.

進入 2017 年，我們的展望中包含幾個關鍵假設，我想花點時間與大家分享。首先，我們對 2017 年的營收預期範圍包括成長品牌帶來的持續正向動能和近期產品發布。

Our guidance also reflects the continued impact of competition against NEUPOGEN and EPOGEN as well as biosimilar competition against Neulasta commencing in the fourth quarter. We also expect competitive dynamics to result in limited net selling price yield through 2017. In particular, for Enbrel, as well as our contract extension with DaVita related to ESAs, as previously disclosed.

我們的指導意見也反映了來自 NEUPOGEN 和 EPOGEN 的持續競爭的影響，以及從第四季度開始來自 Neulasta 的生物相似藥競爭的影響。我們也預計，到 2017 年，競爭格局將導致淨售價收益率有限。特別是對於 Enbrel，以及我們與 DaVita 就 ESA 相關的合約延期，正如先前披露的那樣。

Next, we expect an unfavorable impact due to foreign exchange headwinds of approximately 1 percentage point to revenue growth and an approximate $0.20 unfavorable impact to non-GAAP EPS on a year-over-year basis, assuming current exchange rates prevail through 2017. With respect to other revenue, in 2016, we benefited from rising royalty income as well as several outlicensing transactions which we do not expect will repeat in 2017.

接下來，我們預計，由於外匯逆風，收入成長將受到約 1 個百分點的不利影響，非 GAAP 每股盈餘將受到約 0.20 美元的不利影響（假設當前匯率持續到 2017 年）。至於其他收入方面，2016 年我們受益於不斷增長的特許權使用費收入以及幾筆對外授權交易，但我們預計 2017 年不會再出現這種情況。

Therefore, we expect 2017 other revenue to be about $200 million less than in 2016. Finally, today's revenue and non-GAAP EPS guidance ranges are wider than we typically have provided in the past, which is primarily a reflection of the Repatha legal case potential results as well as how quickly payers provide access to appropriate patients as a result of the positive Repatha Cardiovascular outcomes data.

因此，我們預計 2017 年其他收入將比 2016 年減少約 2 億美元。最後，今天給出的收入和非GAAP每股收益預期範圍比我們過去通常給出的範圍要寬，這主要反映了Repatha法律案件的潛在結果，以及由於Repatha心血管療效數據積極，支付方能夠多快地為合適的患者提供治療。

With this background, our 2017 revenue guidance is $22.3 billion to $23.1 billion, and our non-GAAP earnings per share guidance is $11.80 to $12.60 per share. In addition, our non-GAAP tax rate guidance is 18.5% to 19.5%. We expect capital expenditures to be approximately $700 million this year. As part of our commitment to capital allocation to shareholders, we plan to repurchase shares in a range of $2.5 billion to $3.5 billion in 2017.

基於此背景，我們預計 2017 年營收為 223 億美元至 231 億美元，非 GAAP 每股盈餘預計為 11.80 美元至 12.60 美元。此外，我們的非GAAP稅率預期為18.5%至19.5%。我們預計今年的資本支出約為7億美元。作為我們對股東資本配置承諾的一部分，我們計劃在 2017 年回購 25 億美元至 35 億美元的股票。

As a result of our strong progress through 2016, as well as our 2017 outlook, we remain confident we will meet or exceed the commitments provided for the 2014 to 2018 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.

由於我們在 2016 年取得了強勁的進展，以及我們對 2017 年的展望，我們仍然有信心實現或超越 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% 股東GAAP 淨收入。

Our 2017 guidance ranges are based on application of existing laws, including the Affordable Care Act and the current US tax code, as well as current interpretation of the required 180-day notice period prior to commercial marketing of a biosimilar under the BPCIA. If any of these change in ways that are significant to our outlook, we will provide an updated view on guidance at that time.

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) 對生物相似藥商業化上市前 180 天通知期的當前解釋。如果這些因素中的任何一項發生重大變化，對我們的前景產生重大影響，我們將屆時提供更新後的指導意見。

In summary, we delivered another year of strong financial results in 2016 and we are increasingly confident in the outlook for Amgen's success in 2017 and beyond. This concludes the financial update. I will now turn the call over to Tony.

總而言之，我們在 2016 年又取得了強勁的財務業績，我們對安進在 2017 年及以後的成功前景越來越有信心。財務更新到此結束。現在我將把電話轉給托尼。

Thank you, David. You'll find a summary of our performance for the fourth quarter on slide number 11. We had a strong finish to 2016, delivering fourth quarter sales growth of 6% year over year. FY16 sales grew by 5% to a total of $21.9 billion. Our teams delivered this growth whilst absorbing significant loss of EPOGEN and NEUPOGEN sales to competition.

謝謝你，大衛。您可以在第 11 頁投影片上找到我們第四季的業績總結。2016 年末，我們取得了強勁的業績，第四季銷售額年增 6%。2016財年銷售額成長5%，總額達219億美元。我們的團隊在承受 EPOGEN 和 NEUPOGEN 銷量因競爭對手而遭受的重大損失的同時，實現了這一增長。

Growth in the fourth quarter was principally driven by Enbrel, Prolia, and our newer products, Repatha and KYPROLIS. Growth was also relatively balanced across geographies, with US growth of 7% and international growth of 5% year over year. International growth was 7%% excluding the impact of foreign exchange and was fueled by an 11% volume growth.

第四季的成長主要得益於 Enbrel、Prolia 以及我們的新產品 Repatha 和 KYPROLIS。各地區的成長也相對均衡，美國年增 7%，國際年增 5%。不計匯率影響，國際市場成長7%，銷售成長11%，推動了這項成長。

Our performance in 2016 was successful across several dimensions. We continued to drive strong volume growth of many of our brands, particularly Prolia, XGEVA, Nplate, Vectibix, KYPROLIS and Sensipar. Our international business delivered double-digit volume growth.

我們在2016年的表現各方面都取得了成功。我們持續推動旗下許多品牌的銷售強勁成長，特別是 Prolia、XGEVA、Nplate、Vectibix、KYPROLIS 和 Sensipar。我們的國際業務實現了兩位數的銷售成長。

We laid the groundwork for future growth with numerous product launches outside the United States, led by Repatha and KYPROLIS which are off to strong starts in these markets. Our life cycle management efforts in the US continued to be effective, evidenced by the uptake of Neulasta Onpro and Aranesp in the dialysis setting. We've also begun our launch preparations for the next wave of product launches, including Parsabiv, EVENITY, and Erenumab.

我們透過在美國以外地區推出眾多產品，為未來的成長奠定了基礎，其中 Repatha 和 KYPROLIS 在這些市場取得了強勁的開局。我們在美國的生命週期管理工作持續取得成效，Neulasta Onpro 和 Aranesp 在透析領域的應用證明了這一點。我們也已經開始為下一波產品上市做準備，包括 Parsabiv、EVENITY 和 Erenumab。

Let's now turn to product specific performance, beginning with our bone health franchise. Prolia delivered 25% year over year growth for the full year and a 22% year-over-year growth for the fourth quarter, as we continued to increase share in our core markets.

現在讓我們來看看特定產品的性能，首先從我們的骨骼健康產品系列開始。Prolia全年較去年同期成長25%，第四季年增22%，我們在核心市場的佔有率持續成長。

Prolia represents a unique opportunity. It has a strong clinical profile with a proven ability to reduce the risk of fractures combined with strong long-term safety data. Prolia is the market leader and continues to grow in a significantly unserved disease. For context, it's estimated that maybe 200 million people worldwide suffer from osteoporosis.

Prolia 代表著一個獨特的機會。它具有良好的臨床效果，已被證實能夠降低骨折風險，並擁有強大的長期安全性數據。Prolia是市場領導者，並且在尚未充分滿足的疾病領域中持續成長。作為參考，據估計，全世界約有 2 億人患有骨質疏鬆症。

In the US, Europe and Japan, less than 50% of these people are diagnosed and only half of those are treated. In addition, between 2000 and 2011, there were 4.9 million hospitalizations from osteoporotic fractures in the US alone. We believe there's an opportunity to improve PMO diagnosis and treatment rates and are focusing efforts in this area.

在美國、歐洲和日本，只有不到 50% 的這類患者得到診斷，而其中只有一半接受治療。此外，2000 年至 2011 年間，光在美國就有 490 萬人因骨質疏鬆性骨折住院。我們認為有機會提高 PMO 的診斷和治療率，並將努力集中精力於此領域。

Overall, we expect Prolia to remain a significant growth driver for us in the foreseeable future. We're also excited about expanding our bone health franchise with EVENITY, our innovative bone building molecule, which is under review at the FDA. We look forward to commercializing EVENITY globally with our partner, UCB.

總體而言，我們預計在可預見的未來，Prolia 仍將是我們重要的成長動力。我們也很高興能透過 EVENITY（我們創新的骨骼建構分子）來擴展我們的骨骼健康產品線，目前正在接受 FDA 的審查。我們期待與合作夥伴 UCB 一起在全球實現 EVENITY 的商業化。

Turning now to ESAs. As we previously announced, we recently renegotiated our ESA supply agreement with DaVita. DaVita represents approximately one-third of the US dialysis market and will continue to predominantly purchase EPOGEN. Our new contract replaces the previous one, extending our relationship to the end of 2022.

現在來說說環境敏感動物吧。正如我們之前宣布的那樣，我們最近與 DaVita 重新談判了 ESA 供應協議。DaVita 約占美國透析市場的三分之一，並將繼續主要採購 EPOGEN。我們的新合約取代了先前的合同，將我們的合作關係延長至 2022 年底。

In order to continue this strong partnership for a longer duration, as well as helping to increase certainty, we made some concessions to net selling price beginning in 2017. I'd point out that we don't expect a biosimilar entrant in the US until late 2017 at the earliest.

為了使這種牢固的合作關係能夠更長久地持續下去，並有助於提高確定性，我們從 2017 年開始對淨售價做出了一些讓步。我想指出的是，我們預計最早也要到 2017 年底才會有生物相似藥進入美國市場。

As David said, this assumes that the current interpretation of the required 180-day notice period prior to commercial marketing of a biosimilar under BPCIA is upheld. Aranesp grew 5% year over year, primarily from gains in the mid-size and independent dialysis organizations as they transition from EPOGEN.

正如大衛所說，這假設目前對《生物製品價格競爭與創新法案》(BPCIA) 下生物相似藥商業化上市前 180 天通知期的解釋得到維持。Aranesp 年成長 5%，主要得益於中型和獨立透析機構從 EPOGEN 過渡到 Aranesp 所帶來的成長。

As we noted in our third quarter call, we believe the majority of this transition is now complete. EPOGEN's rate of decline slowed to 8% year over year in the fourth quarter. Recall that Fresenius' transition to an alternative product began in the fourth quarter of 2015.

正如我們在第三季電話會議上提到的那樣，我們認為這次過渡的大部分工作現在已經完成。第四季度，EPOGEN 的年減速度放緩至 ​​8%。回想一下，費森尤斯向替代產品的過渡始於 2015 年第四季。

Sensipar increased 7% year over year in the fourth quarter due to net selling price and unit growth with underlying TRx growth in the US of over 5% year over year. We recently launched Parsabiv in a few of the smaller markets in Europe with about 10 more expected by the end of 2017.

由於淨售價和銷量增長，Sensipar 第四季度同比增長 7%，其中美國潛在 TRx 同比增長超過 5%。我們最近在歐洲一些較小的市場推出了 Parsabiv，預計到 2017 年底還將有大約 10 個市場推出 Parsabiv。

We look forward to launching in the US following FDA approval. Once approved by the FDA, we'll work with CMS to secure reimbursement, which we expect will take between three to four months after approval.

我們期待在獲得FDA批准後在美國上市。一旦獲得 FDA 批准，我們將與 CMS 合作以確保報銷，我們預計這將在批准後三到四個月內完成。

Moving now to Enbrel, where the market growth continued in the fourth quarter with over 20% year-over-year growth in value for both the rheumatology and the dermatology segments. Sequentially, market share of Enbrel in both segments remained relatively steady in the quarter.

現在來看看恩利（Enbrel），其市場成長在第四季度持續保持，風濕病和皮膚病領域的價值年增均超過 20%。本季度，恩利在兩個細分市場的市佔率均保持相對穩定。

Enbrel's fourth quarter sales benefited from an increase in end customer inventory levels. We expect about $150 million of this to reverse in the first quarter this year. As we previously stated, we expect to realize minimal net selling price growth throughout 2017 based on contract that went into effect on January 1. We also expect volume trends in 2017 to be similar to 2016.

恩利公司第四季的銷售額受惠於終端客戶庫存水準的提高。我們預計今年第一季其中約有 1.5 億美元將出現逆轉。正如我們之前所述，根據1月1日生效的合同，我們預計2017年全年淨售價增長將微乎其微。我們也預期2017年的銷售趨勢將與2016年類似。

We continue to invest strategically in Enbrel, including pursuit of new indications and novel delivery systems to enhance the value it brings to patients and providers. Given its long period of patent protection, Enbrel will continue to generate significant cash flows for many years to come.

我們將繼續對恩利進行策略性投資，包括尋求新的適應症和新型給藥系統，以增強其為患者和醫療服務提供者帶來的價值。鑑於其專利保護期較長，恩利在未來很多年將繼續產生可觀的現金流。

Let's now turn to our oncology brand, beginning with Neulasta. Neulasta declined 3% year-over-year due to lower unit volume, partially offset by net selling price. Sequential unit volume in the fourth quarter was adversely impacted by heavier purchasing by some customers in the US during the third quarter. Fourth quarter sales of Neulasta also benefited from a single $38 million purchase by the US Biomedical Advanced Research and Development Authority, otherwise known as BARDA.

現在讓我們來看看我們的腫瘤品牌，首先是 Neulasta。由於銷量下降，Neulasta 同比下降 3%，但淨售價的上漲部分抵消了這一影響。第四季的銷售量較上季受到第三季美國部分顧客大量採購的不利影響。Neulasta 第四季的銷售額也得益於美國生物醫學高級研究與發展局（簡稱 BARDA）的一筆 3,800 萬美元的採購。

Based on the best available data, there appears to be a small decline in the use of myelosuppressive chemotherapy regimens. Our Neulasta lifecycle management has helped to compensate for this reduction, however. The strategy includes investing in our DTC campaign, focused on raising awareness of febrile neutropenia risk, as well as the benefits of Onpro delivery kit.

根據現有最佳數據，骨髓抑制性化療方案的使用似乎略有下降。然而，我們的 Neulasta 生命週期管理有助於彌補這一減少。該策略包括投資我們的 DTC 活動，重點是提高人們對發燒性嗜中性白血球減少症風險的認識，以及 Onpro 輸液套裝的好處。

As expected, we've seen an increase in the average number of Neulasta cycles for patients being treated with the Onpro. Onpro continues to gain traction and exited 2016 with approximately 50% share in the US for all Neulasta sales. We are focused on continued growth given the value Onpro brings to patients and providers and expect Onpro will be a key differentiator for future competition.

正如預期的那樣，我們發現接受 Onpro 治療的患者平均需要 Neulasta 治療週期數增加。Onpro 持續獲得市場認可，到 2016 年底，其在美國 Neulasta 所有銷售額中佔據了約 50% 的份額。鑑於 Onpro 為患者和醫療服務提供者帶來的價值，我們專注於持續成長，並期望 Onpro 將成為未來競爭的關鍵差異化因素。

Finally, as David mentioned, we do not expect any long-acting biosimilar competition until fourth quarter 2017, assuming the current interpretation of the 180 days is upheld.

最後，正如大衛所提到的，假設目前對 180 天的解釋得到維持，我們預計在 2017 年第四季之前不會出現任何長效生物相似藥的競爭。

NEUPOGEN exited 2016 holding over 50% of the short-acting market in the US. We expect competitive trends to continue into 2017 from existing and potentially new biosimilar competition. We also now face biosimilar competition in Canada. Overall, we expect the impact from competition in 2017 to be similar in a relative magnitude as was in 2016.

截至 2016 年底，NEUPOGEN 在美國短效市場佔有超過 50% 的份額。我們預計，來自現有和潛在的新生物相似藥的競爭趨勢將持續到 2017 年。我們現在在加拿大也面臨生物相似藥的競爭。整體而言，我們預期 2017 年競爭的影響在相對程度上與 2016 年相似。

XGEVA grew 6% year over year as we continued to emphasize its clinical benefits. We look forward to having the positive multiple myeloma study data added to our label to provide these patients with a new treatment alternative. For Vectibix and Nplate, we see good year-on-year unit growth.

由於我們持續強調其臨床優勢，XGEVA 年比成長 6%。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，為這些患者提供新的治療選擇。Vectibix 和 Nplate 的銷量均實現了良好的同比增長。

Moving now to KYPROLIS. Multiple myeloma is a growing but competitive market given the number of new treatment options. In the fourth quarter, KYPROLIS unit volume grew in both the US and international markets. We are focused on growing our business in the second-line setting on the compelling ASPIRE and ENDEAVOR data.

現在轉到 KYPROLIS。由於新的治療方案越來越多，多發性骨髓瘤市場正在不斷成長，但競爭也日益激烈。第四季度，KYPROLIS 在美國和國際市場的銷售量均有所成長。我們專注於利用ASPIRE和ENDEAVOR研究的強大數據，在二線治療領域發展業務。

In the US, the focused messages of our recent campaigns are resonating with oncologists in this crowded and dynamic market. Outside the US, we continue to enter into new markets and secure reimbursement. KYPROLIS has strong uptake internationally in the fourth quarter with a sequential unit growth of over 10%. In Europe, new patient share exceeded 20% in the second-line setting and exceeded 30% in the third-line setting.

在美國，我們近期宣傳活動傳遞的重點訊息在這個競爭激烈、瞬息萬變的市場中引起了腫瘤科醫師的共鳴。在美國以外，我們繼續開拓新市場並獲得報銷。KYPROLIS 在第四季國際市場表現強勁，銷售量較上季成長超過 10%。在歐洲，二線治療的新患者份額超過 20%，三線治療的新患者份額超過 30%。

Turning now to our cardiovascular franchise. In two years, we have firmly established ourselves in the cardiovascular space. Our first product, Corlanor, helped us develop relationships and learn the market. Corlanor will continue to play a unique and essential role for certain patients.

接下來我們來看看心血管方面的產品。兩年內，我們已在心血管領域站穩腳步。我們的第一款產品 Corlanor 幫助我們建立了客戶關係並了解了市場。Corlanor 將繼續為某些患者發揮獨特且重要的作用。

Nonetheless, we expect Corlanor will remain a niche product with modest sales of under $50 million in 2017 due to its limited label. Repatha, our second cardiovascular brand, represents one of our largest opportunities. I'm very pleased with the strong competitive execution by our team since launch. We continue to increase our share of new to brand prescriptions in the US and in fact, have captured just over 60% to date in January 2017.

儘管如此，由於其有限的標籤，我們預計 Corlanor 仍將是一款小眾產品，2017 年的銷售額將低於 5,000 萬美元。Repatha 是我們的第二個心血管品牌，代表我們最大的機會之一。我對我們團隊自產品上市以來展現出的強大競爭力感到非常滿意。我們在美國新開品牌藥處方中所佔份額持續成長，事實上，截至 2017 年 1 月，我們已經佔據了超過 60% 的份額。

Our focus here remains on enabling access for appropriate patients. In Europe, we've made very good progress since approval in July 2015. We've now secured reimbursement in 14 markets, with more expected in 2017. We are the market leader in Europe, with a 57% market share.

我們目前的重點仍然是確保合適的患者能夠獲得醫療服務。自 2015 年 7 月獲得批准以來，我們在歐洲取得了非常好的進展。我們目前已在 14 個市場獲得報銷，預計 2017 年將有更多市場獲得報銷。我們在歐洲市場處於領先地位，市佔率為57%。

In closing, I'm proud of the team's execution. We delivered results in 2016 in the face of intensifying competition. As we enter 2017, I'm confident that we will continue to increase our level of competitiveness, enabling us to exercise our strategy of delivering innovative therapies to patients suffering from grievous illnesses. Let me now pass it to Sean.

最後，我對團隊的執行力感到自豪。面對日益激烈的競爭，我們在2016年取得了業績。進入 2017 年，我相信我們將繼續提高競爭力，從而能夠實施我們的策略，為身患重疾的患者提供創新療法。現在我把麥克風交給肖恩。

Thanks, Tony. Good afternoon. There's been a lot of progress in R&D since our last call and I'll begin my comments with our cardiovascular therapeutic area. Cardiologists have been looking for many years for an agent that could be used to treat patients already on statins who are nonetheless at high risk for cardiovascular events.

謝謝你，托尼。午安.自上次通話以來，研發領域取得了很大進展，我將首先談談我們的心血管治療領域。多年來，心臟科醫生一直在尋找一種藥物，可以用來治療已經服用他汀類藥物但仍有較高心血管事件風險的患者。

At the American Heart Association meetings in November, the cardiology community was excited to see in our intracoronary ultrasound study, GLAGOV, not only plaque regression when Repatha was added on top of optimized statin therapy in patients with established atherosclerotic heart disease, but also continued plaque reduction down to LDL cholesterol levels in the 20-milligram per deciliter range.

在 11 月舉行的美國心臟協會會議上，心臟病學界欣喜地看到，在我們的冠狀動脈內超音波研究 GLAGOV 中，不僅在已確診動脈粥樣硬化性心臟病的患者中，在優化的他汀類藥物治療基礎上添加 Repatha 後斑塊消退，而且還持續減少斑塊，使 LDL 膽固醇水平降至每分升 20 毫克。

Our hypothesis from inception of the Repatha program has been the that one should strive maximally to inhibit PCSK9, and thereby maximally reduce LDL to the greatest benefit in patients at high risk for cardiovascular events and that it makes no sense to treat to an arbitrary LDL goal in such patients.

從 Repatha 計畫啟動之初，我們的假設就是，應該盡最大努力抑制 PCSK9，從而最大限度地降低 LDL，使心血管事件高風險患者獲得最大益處；而對於這類患者來說，設定任意的 LDL 目標進行治療是沒有意義的。

Now, in our FOURIER outcomes trial, we have met the primary composite endpoint comprised of non-fatal MI, non-fatal stroke, non-fatal, cardiovascular death, coronary revascularization, or hospitalization for unstable angina as well as the key secondary composite endpoint around which the study was statistically powered.

現在，在我們的 FOURIER 結果試驗中，我們已經達到了主要複合終點，包括非致命性心肌梗塞、非致命性中風、非致命性心血管死亡、冠狀動脈血運重建或不穩定型心絞痛住院，以及該研究在統計上具有效力的關鍵次要複合終點。

This is the more objective MACE, or major adverse cardiac event endpoints being non-fatal MI, non-fatal stroke or cardiovascular death. Furthermore, we did not observe any new safety findings in this large placebo-controlled study. We've also seen the results of an approximately 1,900 patient study of patients in FOURIER that evaluated changes in cognitive function over time, which met its primary endpoint of non-inferiority to placebo.

這是更客觀的 MACE，即主要不良心臟事件終點，包括非致命性心肌梗塞、非致命性中風或心血管死亡。此外，在這項大型安慰劑對照研究中，我們沒有觀察到任何新的安全性問題。我們也看到了 FOURIER 研究中約 1900 名患者的研究結果，該研究評估了認知功能隨時間的變化，達到了其主要終點，即不劣於安慰劑。

From a scientific and medical standpoint, FOURIER and GLAGOV studies provide a set of landmark results, clearly validating the PCSK9 mechanism. Remember, this is in treatment context of a high hurdle of Repatha being given on top of optimized statin therapy. These are patients with no other meaningful therapeutic options for further LDL lowering.

從科學和醫學角度來看，FOURIER 和 GLAGOV 研究提供了一系列里程碑式的結果，清楚地驗證了 PCSK9 機制。請記住，這是在治療背景下，在優化的他汀類藥物治療基礎上加用 Repatha 的較高門檻。這些患者沒有其他有意義的治療方案來進一步降低低密度脂蛋白膽固醇（LDL）。

Bear in mind, the population studied in FOURIER has an approximately 50% 10-year residual risk of experiencing a CV event, despite optimized statin therapy and these patients are quite representative of the large number of patients like this out there in day-to-day medical practice.

請記住，FOURIER 研究族群即使接受了優化的他汀類藥物治療，10 年內發生心血管事件的殘餘風險仍約為 50%，而且這些患者在日常醫療實踐中也相當具有代表性，代表了大量類似的患者。

We look forward to presenting the data at the American College of Cardiology Scientific Session in March. Since statins were introduced 30 years ago, our industry's been seeking a safe and effective agent to extend beyond the benefits of statin therapy.

我們期待在三月的美國心臟病學會科學會議上展示這些數據。自從他汀類藥物在 30 年前問世以來，我們這個行業一直在尋找一種安全有效的藥物，以擴大他汀類藥物治療的益處。

From the seminal initial association in academia of PCSK9 gene variance in humans to abnormal LDL levels and cardiovascular risk, to Amgen's elucidation of the complex biology involved, and our resulting intellectual property around Repatha, and through our extensive set of clinical trials culminating in GLAGOV and FOURIER, this program's been a remarkable example of the power of human validation of a drug target from the very beginning, based on human genetic insights.

從學術界最初發現人類 PCSK9 基因變異與 LDL 水平異常和心血管風險之間的關聯，到安進公司闡明其中涉及的複雜生物學機制，以及由此產生的 Repatha 知識產權，再到我們開展的大量臨床試驗最終促成了 GLAGOV 和 FOURIER 的問世，該項目從一開始就基於人類遺傳學見解，成為藥物靶點人體力量的一個傑出靶證人體力量的一個傑出靶點人體力量。

I'm proud of the role Amgen has played here and our efforts to drive this paradigm forward and many other programs with our leading human genetics platform at deCODE, and our broad suite of modalities to interdict such targets. I'm also pleased to report that the Omecamtiv mecarbil program in collaboration with Cytokinetics and Servier is advancing nicely and our 8,000 patient Phase 3 outcome study in chronic heart failure is now actively enrolling patients.

我為安進公司在這裡發揮的作用以及我們為推動這一範式向前發展所做的努力感到自豪，我們利用 deCODE 領先的人類遺傳學平台和廣泛的療法組合來阻斷此類靶點，開展了許多其他項目。我也很高興地報告，與 Cytokinetics 和 Servier 合作的 Omecamtiv mecarbil 計畫進展順利，我們針對慢性心臟衰竭的 8,000 名患者的 3 期療效研究目前正在積極招募患者。

We have also completed enrollment in the Phase 2 study of chronic heart failure patients in Japan, and we expect to see the results later this year. Finally, in cardiovascular, we've recently submitted an sBLA for a pediatric indication for Corlanor.

我們已經完成了在日本開展的慢性心臟衰竭患者二期研究的招募工作，預計今年稍後看到結果。最後，在心血管領域，我們最近提交了Corlanor用於兒科適應症的sBLA申請。

In oncology, we announced the collaboration with Janssen to evaluate the combination of KYPROLIS and DARZALEX, two very powerful agents for the treatment of multiple myeloma. The first study, to initiate, will be a Phase 3 registrational study of KYPROLIS plus DARZALEX plus dexamethasone versus KYPROLIS plus dexamethasone in the relapsed setting with enrollment expected to begin in the second quarter of this year.

在腫瘤學領域，我們宣布與 Janssen 合作，評估 KYPROLIS 和 DARZALEX 這兩種治療多發性骨髓瘤的強效藥物的組合療效。首先啟動的研究將是一項 KYPROLIS 加 DARZALEX 加地塞米松與 KYPROLIS 加地塞米鬆在復發治療中的 3 期註冊研究，預計將於今年第二季度開始招募患者。

We also remain committed to the front-line setting and are in the design phase of the Phase 3 study of KYPROLIS plus Revlimid and dexamethasone, or KRd, versus Velcade plus RD in newly diagnosed transplant-eligible patients. And we'll provide more details on this study as we finalize our plans.

我們也繼續致力於第一線治療，目前正在進行 KYPROLIS 加 Revlimid 和地塞米松（KRd）與 Velcade 加 RD 在新診斷的符合移植條件的患者中的 3 期研究的設計階段。我們將在最終確定計劃後提供更多關於這項研究的細節。

As is common in drug development, especially in oncology, registration requirements evolve with the science as treatment landscapes change. After initial consultation with regulators, our KYPROLIS weekly administration study, ARROW, had been designed with an overall response rate as the primary endpoint.

正如藥物研發，特別是腫瘤藥物研發中常見的情況一樣，隨著治療格局的變化，註冊要求也會隨著科學的發展而演變。在與監管機構進行初步諮詢後，我們設計了 KYPROLIS 每週給藥研究 ARROW，並將整體回應率作為主要終點。

Based on recent feedback from regulators, response rate is no longer deemed an acceptable endpoint in this clinical context. Therefore, we amended the protocol, making progression-free survival the primary endpoint. As this is an event-driven endpoint, we now expect the results from the final analysis in 2019.

根據監管機構最近的回饋，在此臨床背景下，應答率不再被視為可接受的終點指標。因此，我們修改了方案，將無惡化存活期作為主要終點。由於這是一個事件驅動型終點，我們現在預計最終分析結果將在 2019 年公佈。

We're committed to increasing our footprint in multiple myeloma, and we have several early stage innovative programs ongoing, including an MCL-1 inhibitor in Phase 1 and CD38 and BCMA by specific T cell engaging programs.

我們致力於擴大在多發性骨髓瘤領域的影響力，目前有多個早期創新項目正在進行中，包括處於 1 期的 MCL-1 抑制劑以及透過特定 T 細胞活化計畫針對 CD38 和 BCMA 的療法。

We also intend to make regulatory submissions this year for XGEVA for the prevention of skeletal-related events in multiple myeloma patients. This remains an important area of unmet need, as many of these patients cannot effectively be treated with currently available therapies due to impaired renal function.

我們也計劃今年向監管機構提交 XGEVA 的申請，用於預防多發性骨髓瘤患者的骨骼相關事件。這仍然是一個亟待解決的重要需求領域，因為許多此類患者由於腎功能受損，無法透過目前可用的療法有效治療。

In immuno-oncology, our bispecific programs continue to advance. We'll be working with regulators to update the BLINCYTO label with the overall survival data from our confirmatory study in Philadelphia chromosome-negative relapsed refractory ALL. We're also pursuing new indications for BLINCYTO, including a submission this year for a small but clinically important population of Philadelphia chromosome-positive relapsed refractory ALL patients.

在免疫腫瘤學領域，我們的雙特異性抗體計畫不斷取得進展。我們將與監管機構合作，根據我們在費城染色體陰性復發難治性 ALL 患者中開展的驗證性研究的總生存期數據，更新 BLINCYTO 的標籤。我們也正在尋求 BLINCYTO 的新適應症，包括今年提交一項針對費城染色體陽性復發難治性 ALL 患者（雖然人數不多，但具有重要的臨床意義）的申請。

We're also advancing BLINCYTO into late-stage clinical studies in non-Hodgkin's lymphoma, a much larger indication. While these initial studies will be conducted with our current BLINCYTO construct, we'll also be pursuing an extended half-life version in this setting. In fact, we'll be advancing several extended half-life BiTE molecules into clinic this year, directed at various targets.

我們也正在推動 BLINCYTO 在非何杰金氏淋巴瘤（一個更大的適應症）的後期臨床研究。雖然這些初步研究將使用我們目前的 BLINCYTO 結構進行，但我們也將在此環境下研究半衰期延長的版本。事實上，今年我們將推進幾種針對不同標靶的長半衰期 BiTE 分子進入臨床階段。

We're also making good progress with AMG 330, our CD33 BiTE for acute myelogenous leukemia which is progressing through dose escalation in Phase 1. Within our growing multiple myeloma portfolio, we have several immuno-oncology programs we're excited about, including our BiTE specific CD38 molecule from Xencor and our BCMA BiTE, AMG 420, that's currently in Phase I.

我們針對急性髓性白血病的 CD33 BiTE 藥物 AMG 330 也取得了良好進展，目前正在進行第 1 期劑量遞增試驗。在我們不斷成長的多發性骨髓瘤產品組合中，我們有幾個免疫腫瘤學計畫令人振奮，包括來自 Xencor 的 BiTE 特異性 CD38 分子和我們目前處於 1 期臨床試驗的 BCMA BiTE 藥物 AMG 420。

The potency of the BiTE platform also makes target selection critical and we've developed the world-class proprietary target investigation platform. To augment this platform, earlier this month, we announced a research collaboration and exclusive licensing agreement with Immatics, who has a unique target discovery capability in order for us to develop next-generation T-cell engaging bispecific immunotherapies.

BiTE 平台的強大功能也使得目標選擇至關重要，我們開發了世界一流的專有目標調查平台。為了增強這個平台，本月初，我們宣布與 Immatics 達成研究合作和獨家授權協議，Immatics 擁有獨特的目標發現能力，以便我們開發下一代 T 細胞參與雙特異性免疫療法。

Switching to bone health, along with our partners at UCB, we continue to make progress with romosozumab, now called EVENITY. We've been having productive interactions with the FDA on our BLA filing for the treatment of osteoporosis in post-menopausal women at increased risk of fracture.

轉向骨骼健康領域，我們與 UCB 的合作夥伴一起，繼續在 romosozumab（現稱為 EVENITY）方面取得進展。我們與 FDA 就我們用於治療停經後婦女骨質疏鬆症（骨折風險增加）的生物製品許可申請進行了富有成效的互動。

We're working toward a July 19 PDUFA date and at this time, it does not appear we'll have an FDA Advisory Committee meeting for this program. We also recently submitted an application for marketing approval in Japan for the treatment of osteoporosis for men and women at high risk of fracture.

我們正在努力爭取在 7 月 19 日獲得 PDUFA 批准，但目前看來，該項目似乎不會召開 FDA 諮詢委員會會議。我們最近也向日本提交了治療骨質疏鬆症（適用於骨折高風險男性和女性）的上市許可申請。

We look forward to the primary analysis of the active controlled fracture study, ARCH, in the second quarter. In this randomized, double-blind study, patients receive either alendronate or Romosozumab in year one followed by alendronate in year two.

我們期待在第二季度獲得主動控制骨折研究 ARCH 的主要分析結果。在這項隨機、雙盲研究中，患者在第一年接受阿崙膦酸鈉或羅莫索單抗治療，第二年接受阿崙膦酸鈉治療。

The primary endpoints of this study that will be assessed at the primary analysis are the incidence of vertebral fracture at 24 months and the incidence of clinical fractures, which is event-driven. In addition, at the time of the primary analysis, an interim analysis of the secondary endpoint of non-vertebral fracture will be performed.

本研究的主要終點（將在主要分析中評估）是 24 個月時的椎體骨折發生率和臨床骨折發生率（事件驅動型）。此外，在進行主要分析的同時，也將對非椎體骨折這一次要終點進行中期分析。

In order to assure adequate powering of non-vertebral fracture, we will include an event-driven non-vertebral fracture final analysis. If we do not achieve significance at the time of the primary analysis in Q2, we expect the final analysis of non-vertebral fractures some months after the primary analysis.

為了確保非椎體骨折的充分統計效力，我們將納入事件驅動的非椎體骨折最終分析。如果在第二季度的主要分析中未達到顯著性，我們預計非椎體骨折的最終分析將在主要分析幾個月後進行。

Turning to our neuroscience collaboration with Novartis, I'll begin with our CGRP receptor antibody for migraine prophylaxis, Erenumab. We have successfully completed our registrational studies and are preparing our global regulatory submissions, which we expect to occur in the second quarter. I'd like to commend our team on their execution of this program, in which we're clearly positioned to be first to market and will be seeking registration in both episodic and chronic migraine.

談到我們與諾華公司的神經科學合作，我將首先介紹我們用於預防偏頭痛的 CGRP 受體抗體 Erenumab。我們已成功完成註冊研究，目前正在準備全球監管申報，預計第二季完成。我想表揚我們的團隊對這個計畫的執行，我們顯然已經佔據了市場先機，並將尋求在發作性偏頭痛和慢性偏頭痛領域進行註冊。

Migraine is a devastating condition and it affects millions of patients, often in their most productive years of life, and we believe that for an otherwise active population, a monthly subcutaneous self-administered presentation with a patient-friendly auto-injector pen n would be well-received. In our Alzheimer's program, CNP520 a small molecule base inhibitor, recently received Fast Track designation from the FDA.

偏頭痛是一種毀滅性的疾病，它影響著數百萬患者，而且往往發生在他們生命中最有生產力的時期。我們相信，對於其他方面都很活躍的人群來說，每月一次的皮下自我注射，配合患者方便使用的自動注射筆，將會受到歡迎。在我們的阿茲海默症治療計畫中，小分子鹼基抑制劑 CNP520 最近獲得了 FDA 的快速通道資格認定。

And patient screening is underway in the Phase 3 study we and Novartis are conducting in the Banner Institute. Recall this study will enroll patients genetically predisposed to Alzheimer's disease who are cognitively normal, an approach that differs from many of the ongoing studies in symptomatic patients.

目前，我們和諾華公司正在 Banner 研究所進行的 3 期研究正在進行患者篩選。請記住，這項研究將招募有阿茲海默症遺傳傾向但認知功能正常的患者，這種方法與目前正在進行的許多針對有症狀患者的研究有所不同。

Quickly on Enbrel, we received an expanded indication in the US. making Enbrel the first and only systemic therapy to treat pediatric patients ages four to 17 with chronic, moderate to severe plaque psoriasis. This is particularly noteworthy, as safety is always a particular concern when it comes to treating children.

Enbrel 在美國很快就獲得了擴大適應症的批准。恩利是目前唯一用於治療 4 至 17 歲患有慢性、中度至重度斑塊狀乾癬的兒科患者的全身性療法。這一點尤其值得注意，因為在治療兒童時，安全始終是一個需要特別關注的問題。

In nephrology, we're working toward a February 9 PDUFA action date for Parsabiv for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis. Parsabiv would be the only calcimimetic agent that can be administered intravenously by a healthcare provider three times a week, coincidence with the hemodialysis sessions.

在腎臟病學領域，我們正在努力爭取在 2 月 9 日獲得 PDUFA 批准，用於治療接受透析治療的慢性腎臟病成年患者的繼發性副甲狀腺功能亢進症。Parsabiv 是唯一一種可以由醫療保健提供者每週三次透過靜脈注射給藥的擬鈣劑，與血液透析療程同時進行。

And we believe this would allow physicians to have confidence that their patients are receiving the full benefit of the therapy. We also recently submitted an application to FDA for pediatric indication for our oral calcimimetic, Sensipar.

我們相信這將使醫生確信他們的病人能夠充分受益於這種療法。我們最近也向 FDA 提交了口服擬鈣劑 Sensipar 用於兒科適應症的申請。

Finally, our biosimilar programs continue to advance. In Europe, we recently received a CHMP positive opinion for ABP 501, our biosimilar, Humira. FDA has also accepted our BLA submission for ABP 215, our biosimilar, Avastin, with an action date of September of this year.

最後，我們的生物相似藥計畫仍在持續進行中。在歐洲，我們最近收到了 CHMP 對 ABP 501（我們的生物相似藥 Humira）的正面意見。FDA 也受理我們針對 ABP 215（我們的生物相似藥 Avastin）的 BLA 申請，並將於今年 9 月做出決定。

2016 was a very positive and rewarding year with many significant accomplishments and I'd like to thank all of our staff for their hard work and commitment to deliver important advances in medicine for the many patients still in need. 2017 is going to be another exciting year and I look forward to seeing many of you at ACC. Bob?

2016 年是充滿正面意義且收穫豐富的一年，並取得了許多重大成就。我要感謝我們所有員工的辛勤工作和奉獻精神，為眾多仍需醫療救治的患者帶來了重要的醫學進步。2017年將會是另一個令人興奮的年份，我期待在ACC見到你們中的許多人。鮑伯？

Thank you, Sean. Well, let me just quickly wrap up on the year then we'll open up for questions. As I hope you can tell from our remarks, we have a clear strategy for long-term growth and we're executing it effectively. That's reflected in our financials with 6% revenue growth, 12% EPS and 4 percentage points of margin improvement.

謝謝你，肖恩。好的，我先簡單總結今年的工作，然後我們就可以開始提問了。希望你們能從我們的發言中看出，我們擁有清晰的長期發展策略，並且正在有效地執行該策略。這反映在我們的財務數據中，收入成長了 6%，每股收益成長了 12%，利潤率提高了 4 個百分點。

The Repatha outcome study, we believe will enable us to show once more how we innovation benefits patients and society. The court's recent ruling in our patent litigation is a win for the patent system and patients, as it reinforces incentives for the large and risky investments we have to make in innovation to bring forward new medicines to treat serious diseases.

我們相信，Repatha 的結果研究將使我們能夠再次證明我們的創新如何造福患者和社會。法院最近在我們專利訴訟中的裁決對專利制度和患者來說都是一場勝利，因為它強化了我們在創新方面進行大量且高風險投資的動力，以便推出治療嚴重疾病的新藥。

With respect to innovation, we advanced our next set of late-stage innovative pipeline opportunities and our biosimilars program as well. We generated $10 billion of free cash flow as reflected in our free cash flow yield of 8%.We look forward to working with the administration to advance market-based reforms and solutions that further promote innovation.

在創新方面，我們推動了下一批後期創新產品線計畫以及生物相似藥計畫。我們創造了100億美元的自由現金流，自由現金流收益率達到8%。我們期待與政府合作，推動以市場為導向的改革和解決方案，進一步促進創新。

And as we work to address the headwinds that we've identified for 2017, I'd remind you we made excellent progress on our long-term commitments for 2018 and we're on track to meet or exceed them. With that, Frederick, why don't we open the line for questions? If you wouldn't mind, let's remind our callers once more what the process is for asking questions of us. Thanks.

在我們努力應對 2017 年發現的不利因素之際，我想提醒大家，我們在 2018 年的長期承諾方面取得了優異的進展，並且我們正朝著實現或超越這些承諾的目標穩步前進。那麼，弗雷德里克，我們何不開放提問環節呢？如果您不介意的話，我們再提醒一下來電者向我們提問的流程是什麼。謝謝。

(Operator Instructions)

（操作說明）

Our first question comes from the line of Mark Schoenebaum with Evercore ISI.

我們的第一個問題來自 Evercore ISI 的 Mark Schoenebaum。

Arvind, I need to disappear for three months to get the first question. Thank you so much for your kind words and thanks to your whole team for all the help while I was out. Thanks Bob for the nice note while I was gone. Congratulations to Sean on Repatha. I just had, if I may, I don't know if I'm going get an answer to this, but I thought I might try. Sean, can you give us any information at all around what the predefined non-inferiority margin might have been on the primary endpoint in the neuro cognitive trial? And if you're unwilling to answer that, maybe you can just give me your updated thoughts on the A beta hypothesis in light of the solanezumab failures? Thanks again to everybody.

Arvind，我需要消失三個月才能得到第一個問題。非常感謝您的鼓勵和讚揚，也感謝您的整個團隊在我不在期間給予的幫助。謝謝鮑伯在我不在的時候傳的留言給我。恭喜 Sean 喜提 Repatha。我只是想問一下，如果可以的話，我不知道能不能得到答案，但我還是想試試看。Sean，你能否提供一些關於神經認知試驗主要終點的預先設定的非劣效性界值的資訊？如果你不願意回答這個問題，或許你可以根據 solanezumab 治療失敗的情況，談談你對 A beta 假說的最新看法？再次感謝大家。

Hey first, Mark, on behalf of the team, great to hear your voice. Welcome back. Sean, go ahead. There's two questions there, why don't you --

嗨，馬克，首先我代表團隊，很高興聽到你的聲音。歡迎回來。肖恩，你先來。這裡有兩個問題，為什麼你不——

You only have to answer one.

你只需要回答一個問題。

The first one I can't answer. The second one I would say that we really don't see any read-through on the decision Lilly has made with their antibody to the approach of small molecule BACE inhibition. And I think that I still am a very strong believer in BACE as a drug target and don't believe that really any of the data that's emerging with these antibodies changes the point of view we have on the amyloid hypothesis.

第一個問題我無法回答。第二點我想說的是，我們真的看不到禮來公司對其抗體的決定對小分子 BACE 抑制劑方法的任何影響。而且我認為我仍然非常堅信 BACE 是一個藥物靶點，我不認為這些抗體出現的任何數據會改變我們對澱粉樣蛋白假說的看法。

Sean, you might also just remind Mark and other listeners that we could also see some setbacks for other small molecule programs directed against BACE before we know that there's only CNP520 --

肖恩，你或許還可以提醒馬克和其他聽眾，在我們確定只有 CNP520 這一種藥物之前，其他針對 BACE 的小分子藥物計畫也可能會遭遇一些挫折。

Right. Right. We do have the point of view and it's one that exists in the field as a whole, that it may be too late to intervene in patients who have frank Alzheimer's disease already at the time that we begin to administer these products in relatively short-term clinical trials. And this is why we and a few others are focusing on patients who are predisposed to developing cognitive impairment but are cognitively normal when they enter the treatment phase of the trials.

正確的。正確的。我們確實持有這種觀點，而且這種觀點在整個領域都存在，那就是當我們開始在相對短期的臨床試驗中使用這些產品時，對於已經患有明顯阿茲海默症的患者來說，幹預可能為時已晚。這就是為什麼我們和其他一些研究者將重點放在那些有認知障礙傾向但進入試驗治療階段時認知功能正常的患者身上。

And that's the approach we're taking. So I think we could actually see even some failures of BACE inhibitors before we see success of BACE inhibitors and certainly, the antibodies are a much tougher proposition in my mind.

這就是我們採取的方法。所以我認為，在看到 BACE 抑制劑取得成功之前，我們甚至可能會看到一些 BACE 抑制劑的失敗，而且在我看來，抗體藥物的研發難度要大得多。

Thanks, Sean. Congratulations to you on your trial execution.

謝謝你，肖恩。恭喜你被執行死刑。

Our next question comes from the line of Eric Schmidt with Cowen & Company.

我們的下一個問題來自 Cowen & Company 的 Eric Sc​​hmidt。

Thanks and my congrats also on the FOURIER data. Sean, I know the press release is silent on the other two secondary endpoints, CV mortality and all cause mortality. Should we take that silence to mean that they were missed or just that there's no ability to give us information on that right now? And when do you think you'll be able to submit the data in sBLA form to an FDA label? Thanks.

謝謝，也恭喜你獲得了 FOURIER 數據。肖恩，我知道新聞稿中沒有提及另外兩個次要終點，即心血管死亡率和全因死亡率。我們應該把這種沉默理解為他們失蹤了，還是只是意味著目前我們無法獲得相關資訊？您認為何時能夠以 sBLA 表格的形式向 FDA 提交標籤資料？謝謝。

It's the latter. You should probably not make conclusions about the data based on absence of statements in the press release. And we are working. As you might imagine, this is a reasonably high priority for us at the Company at the moment, so we have people working right now really hard on putting together a filing. So we'll be doing that as fast as we possibly can. And we are working as you might imagine this is a reasonably high priority for you at the Company at the moment so we have people working right now really hard on putting together a filing. So we'll be doing that as fast as we possibly can.

是後者。你不應該因為新聞稿中沒有相關聲明就對數據妄下結論。我們正在努力。正如您所想，這目前是我們公司的一項相當重要的優先事項，所以我們現在有專人正在努力準備相關文件。所以我們會盡快完成這項工作。正如您所料，目前公司非常重視此事，所以我們正在安排人員努力準備相關文件。所以我們會盡快完成這項工作。

Our next question comes from the line of Ying Huang with Bank of America-Merrill Lynch.

我們的下一個問題來自美國銀行美林證券的黃穎女士。

On the Repatha trial, quick one for Sean. You put on your press release that there's a unequivocally connection between LDL lowering and CV risk reduction. Should we infer that by, again, the data kind of like fits where we saw from the meta-analysis before? And secondly, quick question for Bob. When you met with the President earlier this week, you committed to hiring another 1,500 workers in the States. Can we get some color on that? Is it going be for manufacturing operations or is that going be for promotion of Repatha based on this data? Thank you.

關於 Repatha 的試驗，給 Sean 一個簡短的答案。你在新聞稿中明確指出，降低低密度脂蛋白膽固醇與降低心血管疾病風險之間有著毋庸置疑的關聯。我們是否應該推斷，這些數據與我們先前在統合分析中看到的結果有些吻合？其次，我有個問題想問鮑伯。本週早些時候，你與總統會面時承諾將在美國再僱用 1500 名工人。能提供一些細節資訊嗎？這些數據是用於生產運營，還是用於推廣Repatha品牌？謝謝。

What I would say about my comment in the press release about the unequivocal is that just if you think about it, we've done this very large trial which is testing the question of whether Repatha versus placebo has an impact on cardiovascular disease and the trial is statistically significant at these key primary and secondary endpoints.

關於我在新聞稿中提到的「毋庸置疑」的評論，我想說的是，如果你仔細想想，我們已經進行了一項非常大規模的試驗，旨在檢驗 Repatha 與安慰劑相比是否對心血管疾病產生影響，而且該試驗在這些關鍵的主要和次要終點上具有統計意義。

So I think just by definition, that is a validation of the connection between the LDL lowering and the cardiovascular and that's all it's meant to provide, not any magnitude of effect kind of a statement.

所以我覺得，僅從定義上來說，這驗證了 LDL 降低與心血管疾病之間的聯繫，而這正是它所要提供的全部信息，而不是對效果大小的任何陳述。

So, Ying, thanks for your question about the job creation. Couple things, first, these were jobs that were expected, contemplated in our plans for 2017. So this is a reflection both of our ongoing confidence and the attractiveness of the environment here in the US, and of the outlook we have for long-term growth. And we were happy to be able to share that publicly because as I said, that reflects what's our current planning assumptions.

穎，謝謝你提出關於創造就業機會的問題。有幾點需要說明，首先，這些都是我們 2017 年計畫中所預料到的工作。這不僅反映了我們對美國持續成長的信心，也反映了美國環境的吸引力，以及我們對長期成長前景的樂觀態度。我們很高興能夠公開分享這些訊息，因為正如我所說，這反映了我們目前的規劃假設。

So in terms of where the jobs are, really across the business. If you want to look at some specific new areas for us, obviously, we look forward to setting up a neurology franchise with our partners at Novartis. And we have exciting incremental opportunity coming in bone health that we expect to be investing in. And we have some staff that we'll be hiring here to support our ongoing international expansion as well.

所以就工作而言，實際上遍布整個公司。如果您想讓我們探索一些具體的新領域，顯然，我們期待與諾華的合作夥伴一起建立一個神經病學特許經營體系。我們在骨骼健康領域擁有令人興奮的增量機會，我們預計將對此進行投資。我們也會在這裡招募一些員工，以支持我們正在進行的國際擴張。

So as you know, we launched 94 product/country opportunities last year. And so we're continuing to support those with incremental hiring. But generally, in our transformation efforts over the last few years, we've been reallocating resources to where we see the most attractive growth opportunities and we'll continue to do that in 2017.

如您所知，我們去年推出了 94 個產品/國家機會。因此，我們將繼續透過逐步招募來支持這些人。但總的來說，在過去幾年的轉型工作中，我們一直在將資源重新分配到我們認為最具吸引力的成長機會領域，2017 年我們將繼續這樣做。

Thank you.

謝謝。

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

我們的下一個問題來自摩根士丹利的馬修·哈里森。

Great. Thanks. I'm going to try a Repatha question as well and if you don't answer that, I'll have a second one. But you've obviously had a bunch of conversations with payers over the last year and so I know you can't talk about the hazard ratio but maybe you could just comment if the hazard ratio and the data as a whole gives you a high degree of confidence that you've met the demands of payers with this data set to get broader access?

偉大的。謝謝。我打算再問一個關於瑞百莎的問題，如果你不回答，我還是會問第二個。但顯然您在過去一年裡與支付方進行了多次溝通，所以我知道您不能談論風險比，但您能否就風險比和整體數據是否讓您高度確信，您已利用該數據集滿足了支付方的要求，從而獲得更廣泛的訪問權限發表評論？

You want to offer your second question now, Matthew, so we have them both?

馬修，你現在想問第二個問題嗎？這樣我們就能把兩個問題都問完了。

Sure. Bob, I just wanted to ask you, you talked about meeting with the President, some of the goals there. Do you have a view on timelines for when we might see movement around tax reform or some of these other issues?

當然。鮑勃，我只是想問你，你剛才提到了與總統會面，以及會面的一些目標。您對稅制改革或其他一些問題的進度時間表有何看法？

I think the tax reform guidance that's out now in public is probably appropriate. So I don't think tax reform is going to be in the first wave of things to see coming out of the new administration and out of Congress but I think we will see it this year. We talked at some length about this, including comprehensive tax reform and the repatriation and whether they'll be linked or separate.

我認為目前公開的稅制改革指導意見可能是適當的。所以我認為稅制改革不會是新政府和國會上任後最先推出的政策，但我認為今年我們會看到它。我們對此進行了深入討論，包括全面的稅務改革和資金匯回問題，以及這兩者是會連結在一起還是分開進行。

We appreciated the administration and the President's updated guidance on that. But what I'd say, Matthew, is we expect that we'll see it. And generally, I think we're going to find that this is an administration with an action bias and I think they're going to expect to see ideas from us and others in pretty short order here to start addressing some of the concerns that they want to address for the American people.

我們感謝政府和總統就此發布的最新指導。但我想說的是，馬修，我們預計會看到它。總的來說，我認為我們會發現，本屆政府是一個行動導向政府，他們希望我們和其他人能盡快提出一些想法，以開始解決他們想要為美國人民解決的一些問題。

so good news is, we as a Company and we as an industry have some ideas and we look forward to being able to sit down with the administration and Congress and talk about them and see what we can do to work together and make some progress.

好消息是，我們公司和整個行業都有一些想法，我們期待著能夠與政府和國會坐下來討論這些想法，看看我們能做些什麼來共同努力並取得一些進展。

Our next question comes from the line of Terence Flynn with Goldman Sachs.

我們的下一個問題來自特倫斯·弗林在高盛集團的經歷。

Thanks for taking the question. Maybe just one on your 2017 guidance. David, I think you mentioned that there was some wider range than is typical and that really reflects two things with respect to Repatha. One is the legal case and then number two is, how quickly payers provide access given the data you saw. Can you maybe just give us a little bit more context for both of those?

感謝您回答這個問題。或許2017年的指導方針中只有一條。David，我想你提到過，Repatha 的劑量範圍比通常情況要大一些，這實際上反映了 Repatha 的兩個特徵。一是法律案件，二是根據你所看到的數據，支付方能多快提供存取權限。能否再詳細解釋這兩個問題？

Is the commentary around the quickness of access driven by the data itself or is it driven by having these additional discussions? What's driving that? And maybe just any more detail you could share on both of those? Thank you.

圍繞數據存取速度的評論是由數據本身驅動的，還是由這些額外的討論所驅動的？是什麼原因導致這種情況？您能否就這兩點提供更多細節？謝謝。

Yes. So what I would say is as in regards to the litigation, obviously, there's a range of possible outcomes and positions that we have in the market, so we tried to capture all of those in the wider range. And in terms of the uptake, what I would say is maybe Tony would like to comment but we think, again, there's a range of outcomes that you would see with the uptake and the increased access.

是的。所以我想說的是，就訴訟而言，顯然，市場上存在一系列可能的結果和立場，因此我們試圖在更廣泛的範圍內涵蓋所有這些結果和立場。至於普及程度，我想說的是，托尼或許想對此發表評論，但我們認為，隨著普及程度的提高和獲取管道的增加，將會出現一系列不同的結果。

So our focus remains on helping all payers improve access to Repatha. The utilization management criterias they have at the moment is beyond the label and we work every day to improve upon that. We look forward to seeing the payer response now that we have the outcomes data. But of course, we won't be able to promote that until it's in the label.

因此，我們的重點仍然是幫助所有支付方改善獲得瑞百阿（Repatha）的途徑。他們目前的利用管理標準超出了標籤範圍，我們每天都在努力改善這一點。現在我們已經有了結果數據，期待看到支付方的反應。當然，在唱片公司正式發行之前，我們是無法進行宣傳的。

Okay. Frederick, let's take the next question, please.

好的。弗雷德里克，我們來回答下一個問題吧。

Our next question comes from the line of Eun Yang with Jefferies.

我們的下一個問題來自楊恩與傑富瑞的對話。

Thank you. For the product that you increased the prices last year, we estimate that on average, the increase was about 7.45%. Please correct me if I'm wrong. And what was the net realized gain in the price last year?

謝謝。對於您去年漲價的產品，我們估計平均漲幅約為 7.45%。如果我錯了，請指正。那麼去年價格的淨實際漲幅是多少呢？

So we haven't provided specific disclosure on that, although if you look at the -- if you were to go through each of our quarterly calls, we do provide a summary of list price changes, volume, and other factors, right? So I think unless you'd like to comment, Tony? I think you can see it's a number obviously less than 7.5%.

所以我們沒有就此進行具體披露，不過，如果你查看——如果你仔細閱讀我們每一季度的電話會議記錄，我們會提供標價變動、銷量和其他因素的摘要，對吧？所以，除非你想發表評論，托尼？我想你可以看出，這個數字顯然小於 7.5%。

We report every quarter, Eun, the makeup of product changes in terms of units, inventory, and of course at times net selling price which is a combination of list price changes and then contractual changes which impact rebates over time.

Eun，我們每季都會報告產品變化情況，包括數量、庫存，當然有時還會報告淨售價，淨售價是標價變化和合約變化的組合，這些變化會隨著時間的推移影響返利。

Thank you.

謝謝。

Just adding to that, what I think important for us as we look into 2017, as I said in the guidance, we have limited price uptake net in 2017 which is primarily driven by the fact that we, as we said previously, we expect very limited net price on Enbrel and as Tony mentioned again today, we've given some additional discounts as it relates to EPOGEN with DaVita. So what you can expect is that for Amgen in 2017, you'll see a reduced net price including the US pricing, which will be around inflation specs.

補充一點，我認為展望 2017 年，對我們來說重要的是，正如我在指導意見中所說，我們預計 2017 年的淨價格增長有限，這主要是因為我們之前說過，我們預計 Enbrel 的淨價格非常有限，而且正如 Tony 今天再次提到的，我們已經就 DaVita 的 EPOGEN 提供了一些額外的折扣。因此，您可以預期安進公司在 2017 年的淨價（包括美國定價）將會降低，並且將與通貨膨脹率持平。

Let's go to the next question.

我們來看下一個問題。

Our next question comes from the line of Robyn Karnauskas with Citigroup.

我們的下一個問題來自花旗集團的 Robyn Karnauskas。

Hi, guys. Thank you. So Bob, one last question around the Trump meeting. What can you say that might make us more comfortable that we won't see -- because you said he's action based, or it's an action-based administration, make Drug pricing pressure ahead of some reform, like, more aggressive either tweeting or shaving or something that might be implemented ahead of some sort of reform, anything that came out of that?

嗨，大家好。謝謝。鮑勃，關於川普會面，最後一個問題。您有什麼話可以讓我們更安心，因為我們不會看到——因為您說他是一個行動派，或者說這是一個行動派政府——在進行一些改革之前，比如在推特上更積極地施壓藥品價格，或者採取一些可能在某種改革之前實施的措施，您有什麼建議嗎？

And then on the volumes, maybe you could comment a little about is there something nuanced in the fourth quarter that makes you feel comfortable that those -- that the volumes will not continue to decline, there will be less use of these types of drugs over time? What gives you that comfort that you can stabilize that?

關於銷量，您能否稍微評論一下，第四季度是否有一些細微的變化讓您感到放心，認為銷量不會繼續下降，隨著時間的推移，這類藥物的使用量會減少？是什麼讓你感到安心，覺得自己能穩定下來？

Sorry, Robyn. Just to be clear on the second part, are you talking about a particular product or in general?

對不起，羅賓。為了明確第二部分的內容，您指的是某個特定產品還是泛指某個產品？

Sorry. I was just talking about the Neulasta, you commented that there was less per cycle chemo use of these agents. I was just wondering if you could comment on that. Thanks.

對不起。我剛才在談論紐拉斯塔（Neulasta），你評論說這些藥物每個療程的化療用量較少。我只是想問您是否可以對此發表一下看法。謝謝。

I appreciate there's a lot of interest in the discussions we had in Washington and that's why I wanted to try to address it proactively. Again, genuinely, I think that those of us that were there were encouraged by the level of interest that the President has in our businesses and our industry. I think it's encouraged by the respect he has for the importance of innovation.

我知道大家對我們在華盛頓的討論非常感興趣，所以我才想主動回應大家的關注。再次真誠地，我認為在場的我們所有人都受到了總統對我們企業和行業的關注程度的鼓舞。我認為，這得益於他對創新重要性的尊重。

He spoke about the need to eradicate disease in his inaugural address, and I think recognizes the power of innovation to do that. So all that, Robyn, gives us great encouragement. He talked, I think, publicly when we were with him about the need to look at areas of reform, tax reform, regulatory reform, intellectual property protection, trade policy.

他在就職演說中談到了根除疾病的必要性，我認為他認識到創新在實現這一目標方面的力量。羅賓，這一切都給了我們很大的鼓勵。我認為，當我們和他在一起時，他曾公開談到需要審視改革領域，包括稅制改革、監管改革、智慧財產權保護和貿易政策。

So all of those, I think, are encouraging for us. He's also been very clear that drug pricing is something that's important to him, and that I'm sure he's going to want to be able to deliver real benefits to the American public on that score. So obviously, I'm not in a position to comment on what he's going say, when. But I was trying to convey that genuinely, we came away pleased that the administration led by the President was interested in engaging with us on the business and we look forward to working with them and Congress to try to identify things that we all can do differently to help provide access to medicines for the people who need them.

所以我覺得，這一切對我們來說是令人鼓舞的。他也非常明確地表示，藥品定價對他來說非常重要，我相信他一定希望在這方面為美國大眾帶來真正的好處。所以很顯然，我無法評論他會說什麼，什麼時候說。但我真心想表達的是，我們很高興總統領導的政府有興趣與我們探討業務，我們期待與他們和國會合作，努力找出我們可以採取哪些不同的措施來幫助需要藥物的人們獲得藥物。

So again, I know there's an interest on the call and by investors to better understand this but I don't think I could add any other perspective beyond what I've already said, Robyn. With respect to Neulasta, Tony, maybe you can address her question?

所以，我知道電話會議和投資者都有興趣更好地了解這一點，但我認為除了我已經說過的之外，我無法提供任何其他觀點了，Robyn。關於紐拉斯塔的問題，東尼，或許你可以回答？

We've always tried to be as transparent as possible around the data we see coming and then give you guys some heads up as to what we're seeing. The calculation of the number of you myelosuppressive regimens in the US, of course, is a complicated process to go through using a number of databases, and then from that we extract from it the number myelosuppressive chemotherapy regimens and then within that, we look at what actually falls within the label of Neulasta itself.

我們一直努力做到盡可能透明地公開我們看到的數據，然後提前告知大家我們看到的情況。當然，計算美國骨髓抑制療法的數量是一個複雜的過程，需要使用多個資料庫，然後我們從中提取骨髓抑制化療方案的數量，然後在其中，我們研究哪些方案實際上屬於 Neulasta 本身的範疇。

Looking back over the last five, eight years, it continues to fluctuate slightly all the time and when I talk about a decline, I'm talking about a very low single digit number that I see in the last quarter. And we're just watching that carefully, but it's been offset by the incremental cycles we're seeing with Onpro as we use Neulasta.

回顧過去五到八年，它一直在小幅波動，當我談到下降時，我指的是最後一個季度出現的非常低的個位數下降。我們正在密切關注這一點，但由於我們在使用 Neulasta 時 Onpro 的增量週期，這種情況已經得到緩解。

As Bob has said in the past, the number of patients being admitted to hospital with febrile neutropenia continues to increase. And the number of people that die because of that is also on the increase. So the need continues to be there and we continue to work hard to make sure that physicians and patients are aware of the availability of Neulasta.

正如鮑伯過去所說，因發燒性嗜中性白血球減少症入院的患者人數持續增加。而因此喪生的人數也在增加。因此，這種需求仍然存在，我們將繼續努力，確保醫生和患者了解 Neulasta 的供應情況。

Thank you very much.

非常感謝。

Thank you. Let's go to the next question.

謝謝。我們來看下一個問題。

Our next question comes from the line of Michael Yee with RBC Capital Markets.

下一個問題來自加拿大皇家銀行資本市場的 Michael Yee。

I had a question as it relates to expenses and operating margin. Obviously, there's a big benefit windfall from the royalty you won't pay this year. So wanted to understand how much of that do you think could drop to the bottom?

我有一個關於費用和營業利潤率的問題。顯然，今年您無需支付版稅，這將為您帶來巨大的意外之財。所以我想知道，你認為其中有多少會沉到谷底？

And just overall when you think about SG&A and R&D, can you continue to expand operating margins? Because I would think with the CVOT finishing up that there would be some benefit there. So if you look at the two of those, how much operating margin do you have? And how much can you drop from the Pfizer benefit? Thank you so much.

總的來說，考慮到銷售、管理及行政費用和研發成本，你還能繼續擴大營業利潤率嗎？因為我認為隨著 CVOT 的結束，應該會有一些好處。那麼，如果只看這兩點，你的營業利益率是多少？你能從輝瑞福利中扣除多少？太感謝了。

Sure. So I would say on the overall operating margin question and then going to the expense. So we finished last year as we mentioned at 52% and what we were able to convey again today is that we expect to meet or exceed all of our commitments and that would include operating at 52% to 54%. So we continue to feel very good about our performance from a margin perspective.

當然。所以，我會先談談整體營業利益率問題，然後再談談費用問題。正如我們之前提到的，去年我們完成了 52% 的運營，而我們今天再次傳達的訊息是，我們預計能夠實現或超過我們所有的承諾，其中包括營運效率達到 52% 至 54%。因此，從利潤率的角度來看，我們對自身的業績仍然感到非常滿意。

Secondly, if you look at the components of cost and I think about it in 2017; correct, we have quite a significant improvement in our cost base due to the reduction in the royalty that's effective in 2017 as well as the fact that we'll continue to see additional benefits from transformation initiatives incrementally in 2017 as we continue to march towards the $1.5 billion goal.

其次，如果你看一下成本構成，想想 2017 年的情況；沒錯，由於 2017 年生效的特許權使用費減少，我們的成本基礎有了相當大的改善，而且隨著我們繼續朝著 15 億美元的目標邁進，我們將在 2017 年繼續從轉型計劃中逐步獲得額外收益。

And partially offsetting that, and Bob touched on it earlier, we do have new expenses that we're building in the business, in particular, as we launch more products internationally, that adds cost to the base as well as standing up a new neuro franchise for the Company and expanding on bone, will add some cost. So I think net-net, when you net those out, we'll see most of that reduction of the royalty go to the bottom line but not all this year.

部分抵消這一點的是，正如鮑勃之前提到的，我們在業務中確實產生了一些新的支出，特別是隨著我們在國際上推出更多產品，這增加了基礎成本，此外，為公司建立一個新的神經特許經營權和擴展骨科業務也會增加一些成本。所以我覺得總的來說，把這些因素都考慮進去之後，我們會看到大部分的版稅減少會反映在利潤上，但不會全部反映在今年。

But again, we feel very good about the performance of the Company in that we're now operating amongst the top tier in terms of not only efficiency and margin, but we're continuing to invest I think very appropriately in the long-term future of the business.

但是，我們對公司的業績感到非常滿意，因為我們現在不僅在效率和利潤率方面位居前列，而且我們還在繼續對公司的長期未來進行我認為非常恰當的投資。

Thank you.

謝謝。

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

我們的下一個問題來自巴克萊銀行的傑夫·米查姆。

Afternoon, guys. Thanks for taking the question. Again, offer my congrats on the outcomes data. Tony, trying to determine the commercial path for Repatha with the new data. Are there opportunities to have formulary discussions post-ACC or do you think you'll have to wait for the formal PBM negotiation season this fall after the label's expanded?

下午好，各位。感謝您回答這個問題。再次恭喜你們取得如此優異的成績。Tony 正嘗試利用新資料來確定 Repatha 的商業發展路徑。ACC會議之後還有機會進行藥品目錄討論嗎？還是您認為必須等到今年秋季藥品標籤擴大後，才能進行正式的藥品福利管理機構（PBM）談判？

From the revised guidance on the Section 114, we can clearly go out and talk about the top line data and talk conceptually with payers about the value this data brings to them. We can't however, at this particular stage, promote it from a sales perspective because it's not in the label yet but we can talk to payers, yes.

根據修訂後的第 114 條指南，我們可以清楚地與付款方討論主要數據，並從概念上探討這些數據能為他們帶來的價值。但是，在這個階段，我們還不能從銷售的角度進行推廣，因為它還沒有正式發行，但是我們可以和付款方談談。

Got you. Okay. Thanks.

抓到你了。好的。謝謝。

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

我們的下一個問題來自 Ronny Gal 與 Bernstein 的對話。

Thank you for taking my questions. I'll touch on biosimilars here, a couple of them. With interchangeability guidance, are you guys considering starting any interchangeability trials for your [mAb] programs? And does that differ between the anti-TNFs and the oncology program?

謝謝您回答我的問題。我在這裡簡單談談生物相似藥，就舉幾個例子。鑑於互換性指導原則，你們是否考慮針對你們的[mAb]計畫進行任何互換性試驗？抗TNF療法和腫瘤治療方案之間是否有差異？

And then regarding Neulasta, you kind of mentioned the SCOTUS risk for canceling the six months warning. But there's also a chance that they'll reintroduce the patent dance. And if they do, does that essentially mean the Neulasta biosimilar will be delayed deep into 2018? Or is that still outstanding?

至於 Neulasta，你提到了最高法院取消六個月警告的風險。但他們也有可能重新啟用專利舞步。如果是這樣，那是不是意味著 Neulasta 生物相似藥的上市時間將被推遲到 2018 年下半年？或者這件事仍然懸而未決？

I think, Ronny, I'm not sure we want to comment about matters that relate to the ongoing litigation. And with respect to interchangeability, what I would say generally, is that we think that the pathway that looks like going be pursued here in US for interchangeability is consistent with what we've been advocating for and doesn't represent a change from what we've expected. So I think that's probably, from a competitive standpoint, all I want to say at this point. Again, consistent with what our expectations have been and consistent with what we've been advocating for.

羅尼，我覺得我們最好不要對正在進行的訴訟相關事宜發表評論。至於互換性，我總體上想說的是，我們認為美國目前看來將要推行的互換性路徑與我們一直倡導的一致，並沒有改變我們預期的結果。所以，從競爭的角度來看，我想這就是我現在想說的全部了。這再次印證了我們的預期，也印證了我們一直以來所倡導的。

Thanks.

謝謝。

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

我們的下一個問題來自摩根大通的 Cory Kasimov。

Good afternoon, guys and thanks for taking my question. So I'm wondering on the capital allocation front, given that you now have cash balance of nearly $40 billion to go along with significant ongoing free cash flow generation and potential favorable tax policy from the new administration, does this change the types or the size of organizations that you'd potentially be willing to look at relative to the historic strategy you guys have communicated? Thanks.

下午好，各位，感謝你們回答我的問題。所以，在資本配置方面，鑑於你們現在擁有近 400 億美元的現金餘額，加上持續的大量自由現金流以及新政府可能出台的有利稅收政策，這是否會改變你們願意考慮的組織類型或規模，與你們之前公佈的戰略相比？謝謝。

Maybe David and I can double team this, Cory. We have felt for some time that we have a lot of flexibility in our balance sheet to do acquisitions. And I think anything that provides clarity on the tax rate and clarity on the global tax structure will be helpful. It would probably increase our flexibility but again, I think we have felt for some time that we have considerable flexibility to do transactions.

科里，或許我和大衛可以聯手對付他。我們一直覺得，我們的資產負債表有很大的彈性，可以進行收購。我認為任何有助於明確稅率和全球稅收結構的措施都將有所幫助。這或許能提高我們的靈活性，但話說回來，我認為我們已經有一段時間感覺我們在進行交易方面擁有相當大的靈活性。

I know when we've talked in the past about kinds of things we're looking at, we've often talked about it in the context of the big plate of things that we have internally that we're working through. But we feel like we're in a place now where we can look externally for large and small opportunities to help grow the business.

我知道，過去我們討論正在關注的各種問題時，我們經常會把它放在我們正在內部努力解決的一系列大問題的背景下進行討論。但我們感覺現在我們已經到了可以向外部尋找大小機會來幫助業務成長的階段了。

So I think the message is we're confident in the outlook for our Company, we're confident in the importance of innovation and we've got a balance sheet that supports our ability to look at transactions, large and small. David, do you want to add anything to that?

所以我認為，我們傳遞的訊息是：我們對公司的前景充滿信心，我們對創新的重要性充滿信心，而且我們的資產負債表也支持我們進行各種規模的交易。大衛，你還有什麼要補充的嗎？

No, that's right. I would say flexibility, we remain disciplined always in making sure what we're looking at can generate a return for our shareholders, not just the sellers. And I guess from my perspective, I don't really view us even today pre-tax reform as having some arbitrary cap in terms of what we can look at. We think we need to look at all opportunities of all sizes.

沒錯。我認為關鍵在於靈活性，我們始終保持嚴謹的態度，確保我們所關注的事情能夠為股東帶來回報，而不僅僅是為賣方帶來回報。我覺得從我的角度來看，即使在稅制改革之前，我們今天在審查方面也沒有任何任意的上限。我們認為需要考慮所有規模的機會。

Okay. Thank you.

好的。謝謝。

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

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

Congratulations. It's a real milestone. Unfortunately, just a patent-related question. Could you give us a sense of the timing for your expectations for resolution of the PCSK9 litigation? And then related to that, is there any chance of an equivalent patent to the 165 patent in Europe? Do you believe that, that might be infringed?

恭喜。這是一個真正的里程碑。很抱歉，這只是一個與專利相關的問題。您能否大致說明一下您對 PCSK9 訴訟案解決的預期時間？與此相關的是，歐洲是否有可能獲得與 165 號專利等效的專利？你認為這可能構成侵權嗎？

And then lastly, there's some suggestions on Erenumab that some of your competitors have broad IP around the CGRP pathway. Are you confident that you'll be able to launch that product unencumbered and not at risk? Thanks.

最後，還有一些關於 Erenumab 的跡象表明，你們的一些競爭對手在 CGRP 通路方面擁有廣泛的智慧財產權。您是否有信心能夠順利、無風險地推出產品？謝謝。

Okay, Geoff, I think there were three questions there. With respect to your first question, I think we expect the court will rule on the request for the stay of an injunction on or before the 21st of February. With respect to the overall resolution of the case after that, I think it will probably be something in the four to 10 month time frame but we'll know more when we've heard in the courts and that will, of course, be public.

好的，傑夫，我想那裡有三個問題。關於你的第一個問題，我認為我們預計法院將在 2 月 21 日或之前對暫緩執行禁令的請求作出裁決。至於此案最終的解決情況，我認為可能需要四到十個月的時間，但等法庭審理後，我們就會知道更多，而審理結果當然也會公之於眾。

And then with respect to your question about the patent outlook and Europe, obviously we don't like to comment about ongoing litigation so I think I'll hold off on saying anything more than that. Again, with respect to Erenumab, we feel confident in both the clinical profile that's emerged for that molecule as well as our intellectual property portfolio around it.

至於你提出的關於專利前景和歐洲的問題，顯然我們不願意對正在進行的訴訟發表評論，所以我想我還是不要再多說了。再次強調，對於 Erenumab，我們對該分子已展現出的臨床特性以及我們圍繞該分子的智慧財產權組合都充滿信心。

Thanks very much.

非常感謝。

Our next question comes from the line of Salim Syed with Mizuho Securities.

我們的下一個問題來自瑞穗證券的 Salim Syed。

Great. First of all, thanks Arvind for the kind comments and congrats to everybody on the FOURIER data. Just two questions. One's a backup because the first one's on Repatha. So Sean, this is not about the results that you guys now have but it is more about the design.

偉大的。首先，感謝 Arvind 的友善評論，並祝賀大家在 FOURIER 數據方面的成就。就兩個問題。其中一張是備用的，因為第一張是用 Repatha 做的。所以肖恩，這無關你們現在的成果，而更多的是關於設計。

Could you just remind us what you were assuming in terms of bare minimum benefit in order to hit stats, say, based on how you designed the trial? And if you can't answer that, my question's around Enbrel 2018 pricing, for Tony. Is the 2017 net pricing, minimal net pricing benefit, is that a 2017 thing? Or should we assume that for 2018 and going forward as well? Thank you.

您能否提醒我們一下，根據您設計的試驗方案，為了達到統計指標，您假設的最低收益是多少？如果你不能回答這個問題，那麼我的問題是關於 Enbrel 2018 的價格，這是給 Tony 的。2017 年的淨價、最低淨價優惠是 2017 年才有的嗎？或者我們應該假設2018年及以後也是如此？謝謝。

Salim, I think we can answer your first question because that's in public -- the answer's public there.

薩利姆，我認為我們可以回答你的第一個問題，因為那是公開的——答案在那裡是公開的。

The design of the trial is published. And I guess what I would say is that, just always remember that the trial was actually designed around this harder MACE endpoint of the cardiovascular death, non-fatal MI and non-fatal stroke. And there, we wanted to be able to detect with 90% power, a 15% decrease in risk. So that was the design of the study perspective.

試驗方案已公佈。我想說的是，請始終記住，該試驗實際上是圍繞著更難達到的 MACE 終點（心血管死亡、非致命性心肌梗塞和非致命性中風）而設計的。因此，我們希望能夠以 90% 的靈敏度檢測到風險降低 15%。以上就是本研究的設計視角。

Let's go to the next question.

我們來看下一個問題。

Our next question comes from the line of Joshua Schimmer with Piper Jaffray.

我們的下一個問題來自 Joshua Schimmer 和 Piper Jaffray 的問題。

FOURIER results might reshape the cholesterol management guidelines. How important do you think that is for defining the addressable market and enabling Repatha reimbursement and when might those guidelines be revised to reflect results? Thanks.

FOURIER 研究結果可能會改變膽固醇管理指南。您認為這對於確定目標市場和實現 Repatha 報銷有多重要？這些指導方針何時會進行修訂以反映結果？謝謝。

So maybe I can talk a bit about that. Obviously, we look forward to hearing what the ACC and what the AHA have to say when they see the full data. Everyone we've talked to has talked about revising the guidelines once they see the outcomes. And I can't give you guidance on the timing, but obviously if the data is robust enough, we would certainly hope that the guidelines would come forward pretty soon.

所以也許我可以稍微談談這個話題。顯然，我們期待聽到美國心臟病學會 (ACC) 和美國心臟協會 (AHA) 在看到完整數據後會發表什麼意見。我們採訪過的每個人都表示，一旦看到結果，就會修改指導方針。我無法給出具體時間安排，但顯然，如果數據足夠可靠，我們當然希望相關指南能夠盡快出台。

Thank you.

謝謝。

Our next question comes from the line of Ian Somaiya with BMO capital.

我們的下一個問題來自 BMO 資本的 Ian Somaiya。

Thanks. Just maybe following up on the operating margin question. Tony, can you just give a sense for what the plan is for supporting the drugs that are now or will be facing biosimilar competition? And just your own biosimilar portfolio, how should we think about the impact of the launches of those on gross and operating margins?

謝謝。或許我想就營業利益率的問題做個後續說明。東尼，你能否簡單介紹一下，對於目前或將來面臨生物相似藥競爭的藥物，政府的扶持計畫是什麼？就您自己的生物相似藥產品組合而言，我們該如何看待這些產品的上市對毛利率和營業利益率的影響？

The plan for supporting existing products base income.

支持現有產品基礎收入的計劃。

We're having a little trouble hearing you, Ian, but I think we got it.

伊恩，我們聽不太清楚你的聲音，但我想我們聽到了。

So I think your question was what is our plan for supporting existing products that are facing biosimilar competition. Clearly, in places where we believe that the market is evolving to a branded-specific market, we continued to put activity behind the brands. Where they're becoming more commodity like we will reduce activities quite dramatically.

所以，我認為你的問題是，對於面臨生物相似藥競爭的現有產品，我們有什麼計劃來支持它們。顯然，在我們認為市場正在向品牌特定市場發展的地方，我們繼續加大對品牌的投入。如果它們變得越來越像商品，我們將大幅減少相關活動。

With respect, Tony, do you want to comment with respect to either the gross or the operating margin context for own biosimilar portfolio or leave that for another day?

東尼，恕我直言，您是否想就貴公司生物相似藥產品組合的毛利率或營業利潤率發表評論，還是留待以後再談？

I think we've always believed that our own biosimilar will be in a branded type market in therapeutic areas where we have strength and therefore, we'll be using existing teams to bring these to the market as effectively as we can.

我認為我們一直相信，我們自己的生物相似藥將在我們具有優勢的治療領域進入品牌藥市場，因此，我們將利用現有團隊盡可能有效地將這些產品推向市場。

Okay. I think we've got a couple more questions queued up. Let's try to get to those and then we can -- and then Arvind will be here and his team can take any follow-up questions that you all may have. Let's get to our last couple of questions here.

好的。我想我們還有幾個問題可以問。我們先來討論這些問題，然後——之後 Arvind 和他的團隊會在這裡，回答大家可能提出的任何後續問題。讓我們來回答最後幾個問題。

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

我們的下一個問題來自瑞士信貸的 Alethia Young。

Thanks for taking my question. Congrats as well. But on Repatha, maybe you can talk about some of the trends you're seeing with doctors. And are they particularly concerned around the potential for an injunction? I just am wondering if you're starting to see people who are Praluent patients move to Repatha? Thanks.

謝謝您回答我的問題。也恭喜你。但是，在 Repatha 論壇上，或許你可以和醫生聊聊你觀察到的一些趨勢。他們是否特別擔心可能會被頒布禁令？我只是想問一下，您是否開始看到一些服用Praluent的患者轉而服用Repatha？謝謝。

Alethia, it's Tony. So let me give you a response. I mean, we don't track anything other than usage by physicians and the FDA has approved Repatha for all patients, including those presently taking alirocumab and our expectation is all these patients would, in fact, become Repatha patients of the future.

阿萊西亞，我是東尼。讓我來回答你。我的意思是，我們只追蹤醫生的使用情況，而FDA已經批准Repatha用於所有患者，包括目前正在服用alirocumab的患者，我們預計所有這些患者實際上都會在未來成為Repatha的患者。

So we do see, as I said, month to date in January, 60% of new to brand patients are on Repatha. And I'd also add that a vast majority of the physicians that prescribe alirocumab have experience using Repatha, so they know the product and the benefits it provides to their patients.

正如我所說，我們看到，截至 1 月份，60% 的新品牌患者正在使用 Repatha。我還要補充一點，絕大多數開立阿利西尤單抗處方的醫生都有使用瑞百安的經驗，所以他們了解產品及其為病人帶來的益處。

Frederick, as it's about 15 minutes past the hour, let's take two last questions, please.

弗雷德里克，現在已經過了整點15分鐘了，請容許我們再回答最後兩個問題。

Thank you. Our next question comes from the line of Brian Skorney with Robert Baird.

謝謝。我們的下一個問題來自 Brian Skorney 和 Robert Baird 的對話。

Good afternoon, guys. Thanks for taking the question. In your commentary on the Trump administration meeting, you said that you're looking forward to working on market based reform around drug pricing. I just wonder, in the discussion was the idea of allowing CMS to negotiate directly with manufacturers mentioned at all?

下午好，各位。感謝您回答這個問題。您在對川普政府會議的評論中表示，您期待著圍繞藥品定價開展基於市場的改革工作。我只是想知道，在討論中，是否有人提到允許CMS直接與製造商談判的想法？

Is that still something that might be on the table for the administration? And on the regulatory reform front, you had mentioned that he may be naming a new Commissioner of FDA soon. I just wondered if you guys had any insight into how seriously he's taking his Silicon Valley advisors in terms of what seems to be complete reduction of regulatory oversight for new drugs?

這是否仍然是政府考慮的選項之一？在監管改革方面，您曾提到他可能很快就會任命一位新的FDA局長。我只是想知道你們是否了解，他對於矽谷顧問們提出的完全放鬆對新藥監管的建議，究竟有多重視？

Brian, I don't think I could comment on that specifically yet. I think you're right that we expect there will be an announcement about an FDA leader here soon. I think this President takes seriously what he's said about regulatory reform. And I suspect that will be reflected in his choice of a leader for FDA.

布萊恩，我覺得我現在還不能就此發表具體評論。我認為你說得對，我們預計很快就會宣布一位FDA領導人的人選。我認為這位總統認真看待他所提出的監理改革議題。我懷疑這一點會體現在他對FDA領導人的選擇上。

But again, I think we'll all just have to wait and see. And we didn't talk any specifics about the role of HHS. We talked about the need for all of us to work together to address and making medicines affordable and accessible to people who benefit from them, and who need them. But again, it was a constructive discussion, Brian.

但我想，我們只能拭目以待了。我們沒有具體討論衛生與公共服務部（HHS）的角色。我們討論了大家需要共同努力，解決藥品價格昂貴、取得困難等問題，讓需要藥品的人能夠負擔得起藥品。但布萊恩，這仍然是一次建設性的討論。

Let's take one last question.

我們來看最後一個問題。

Our final question comes from the line of Jim Birchenough with Wells Fargo Securities.

最後一個問題來自富國證券的吉姆·伯奇諾夫。

Thanks for fitting me in and congrats on the FOURIER data. Just wondering if there's anything to learn from the statin experience when we first saw outcomes benefits there as to whether the key is the data, the data presentation, the publication of the data, or guideline revision in terms of what really drives the inflection of following these kind of outcomes data? Thanks.

謝謝你安排時間，也恭喜你拿到了 FOURIER 數據。我想知道，當我們最初看到他汀類藥物的療效時，能否從他汀類藥物的經驗中學到些什麼，例如關鍵是數據、數據的呈現方式、數據的發布方式，還是指南的修訂，才能真正推動人們關注這類療效數據？謝謝。

Maybe I can respond to that because I'm probably old enough to remember. What happened in the mid-1990s, the market was dramatically different. It was the first time we'd ever seen real impact of lowering LDL. And clearly, there weren't as many sort of utilization management criteria as exists today. So uptake started quite fast as people saw the value. But it was a brand new concept, so it took a good 10 years to get to the peak of the market.

也許我可以回答這個問題，因為我年紀應該夠大，還記得這件事。1990年代中期，市場發生了翻天覆地的變化。這是我們第一次看到降低低密度脂蛋白膽固醇的真正效果。顯然，當時的資源利用管理標準種類遠不如現在這麼多。因此，隨著人們看到它的價值，它的普及速度非常快。但這畢竟是一個全新的概念，所以花了整整 10 年才達到市場高峰。

All right. I think at this time, we'll wrap up. As I said earlier, Arvind and his team are around for those of you who have follow-on questions or didn't get a chance to ask your questions in the hour and a bit that we've been together. But let me just again thank you for joining the call and say we're looking forward to the year.

好的。我想我們今天就到此為止吧。正如我之前所說，Arvind 和他的團隊隨時準備為那些有後續問題或在我們在一起的一個多小時裡沒有機會提問的人提供幫助。但請容許我再次感謝各位參加這次電話會議，並表示我們非常期待新的一年。

We're excited about the outlook for long-term growth and about the progress that we're making towards our 2018 commitments. So with that, we'll look forward to seeing you all at ACC. Thank you.

我們對長期成長前景感到興奮，並對我們為實現 2018 年承諾所取得的進展感到滿意。那麼，我們期待在ACC見到大家。謝謝。

Thanks, everybody.

謝謝大家。

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

謝謝。今天的電話會議到此結束。您現在可以斷開連線了。