美國安進 (AMGN) 2017 Q3 法說會逐字稿

My name is Ian, and I will be your conference facilitator today for Amgen's Third Quarter 2017 Financial Results Conference Call. (Operator Instructions)

我叫伊恩，今天我將擔任安進 2017 年第三季財務業績電話會議的主持人。（操作說明）

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

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

Okay. Thanks, Ian. Good afternoon, everybody. Thanks for calling in to review and discuss our business performance for the third quarter. Consistent with the tradition that we have now established, I would like to acknowledge those who are new in their coverage or have changed firms recently, including Chris Raymond who recently joined Piper Jaffray; Laura Chico of Raymond James and Kennen MacKay of RBC. Each of us are very much looking forward to working with you.

好的。謝謝你，伊恩。大家下午好。感謝您來電回顧並討論我們第三季的業務表現。秉承我們確立的傳統，我想對那些最近加入報道團隊或更換公司的記者表示感謝，包括最近加入 Piper Jaffray 的 Chris Raymond；Raymond James 的 Laura Chico 和 RBC 的 Kennen MacKay。我們每個人都非常期待與您合作。

Turning to our quarterly performance and keeping with the theme that we articulated at the beginning of the year of growing volumes, our growth products are all benefiting from solid unit volume growth, which is a key component of our long-term growth strategy of effectively transitioning from mature products to the more recently launched products.

回到我們的季度業績，並延續年初我們提出的銷售成長主題，我們的成長型產品都受益於穩健的銷售成長，這是我們長期成長策略的關鍵組成部分，該策略旨在有效地從成熟產品過渡到新推出的產品。

To discuss this, together with other topics, our Chairman and CEO, Bob Bradway, will lead the call today; followed by our CFO, David Meline, who will review our financial results for the third quarter and our revised and tightened outlook for the remainder of 2017. Our Head of Global Commercial Operations, Tony Hooper, will review our product performance during the quarter; followed by our Head of R&D, Sean Harper, who will provide a pipeline update. In addition to posting slides that we plan to use for our presentation today on our website, we have also posted an updated statement on progress we are making with our manufacturing facilities in Puerto Rico following the aftermath of Hurricane Maria.

為了討論這個問題以及其他議題，我們的董事長兼首席執行官鮑勃·布拉德韋將於今天主持電話會議；隨後，我們的首席財務官大衛·梅林將回顧我們第三季度的財務業績以及我們對 2017 年剩餘時間的修訂和收緊的展望。我們的全球商業營運主管托尼·胡珀將回顧本季我們的產品表現；隨後，我們的研發主管肖恩·哈珀將提供產品線更新資訊。除了在網站上發布我們計劃今天演示的幻燈片外，我們還發布了一份更新聲明，介紹了我們在波多黎各的製造工廠在颶風瑪麗亞過後取得的進展。

We plan on using non-GAAP financial measures in today's presentation to provide information, which may be useful in understanding our ongoing business performance. However, these non-GAAP financial measures should be considered together with GAAP results, and reconciliations of these measures are available in the schedules accompanying today's press release 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中以及我們網站的投資者關係部分查閱。

Just a reminder that some of the statements made during the course of our presentation today are forward-looking statements, and our 2017 10-K and subsequent filings identify factors that could cause our actual results to differ materially.

提醒各位，我們今天在演講中所做的一些陳述屬於前瞻性陳述，我們在 2017 年提交的 10-K 表格及後續文件中列出了可能導致我們實際結果與預期結果存在重大差異的因素。

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

那麼，接下來我將把電話交給鮑伯。鮑伯？

Okay. Thank you, Arvind. Our operating results through the first 9 months of the year highlight that we are effectively managing our business during a period of transition as our recently launched products begin to gain traction around the world. Based on our ability to effectively manage costs, we've been able to raise our earnings outlook for full year 2017, even while absorbing the cost of Hurricane Maria and continuing to direct investments towards long-term growth. As I've said before, growing volumes will be key to driving future revenue growth. Our growth brands, including Prolia, Repatha, KYPROLIS and BLINCYTO, are all exhibiting solid unit volume growth.

好的。謝謝你，阿文德。今年前 9 個月的經營業績表明，隨著我們最近推出的產品開始在全球範圍內獲得市場認可，我們正在有效地管理轉型期的業務。憑藉我們有效控製成本的能力，即使在承受了颶風瑪麗亞帶來的損失並繼續將投資導向長期增長的情況下，我們也提高了 2017 年全年的盈利預期。正如我之前所說，銷售成長將是推動未來營收成長的關鍵。我們旗下的成長型品牌，包括 Prolia、Repatha、KYPROLIS 和 BLINCYTO，都展現出穩健的銷售成長。

I'd like to highlight Prolia in particular. Prolia is a unique asset in the bone health area and has an extremely strong value proposition. As you can see in our results, it continues to generate strong volume growth. Osteoporosis remains an under-diagnosed and under-treated disease with serious consequences, and we will continue to educate physicians and patients on the established clinical profile of Prolia and the obvious benefits of preventing fractures.

我想特別提一下Prolia。Prolia 在骨骼健康領域擁有獨特的優勢，並具有強烈的價值主張。正如您從我們的結果中看到的，它持續保持強勁的銷售成長。骨質疏鬆症仍然是一種診斷不足、治療不足的疾病，會造成嚴重的後果。我們將繼續向醫生和患者普及 Prolia 的既定臨床特徵以及預防骨折的明顯益處。

I remain optimistic that Repatha will become a significant product for Amgen as it also brings a compelling value proposition to patients. Repatha's cardiovascular outcomes data are under priority review by the FDA, as you are aware, and this underscores the significant unmet medical need in cardiovascular disease. These data have already been incorporated by global professional societies into treatment guidelines and pathways, including the recent update from the American College of Cardiology.

我仍然樂觀地認為，Repatha 將成為安進公司的一款重要產品，因為它也為患者帶來了極具吸引力的價值主張。如您所知，Repatha 的心血管結果數據正在接受 FDA 的優先審查，這凸顯了心血管疾病領域尚未滿足的重大醫療需求。全球專業協會已將這些數據納入治療指南和路徑中，包括美國心臟學會最近的更新。

As I've said before, cardiovascular disease is the leading cause of death around the world, and it's a disease that costs over $600 billion a year in the U.S. alone. Improving patient access to Repatha remains a top priority for our team.

正如我之前所說，心血管疾病是全世界首要的死亡原因，光是在美國，這種疾病每年就造成超過 6,000 億美元的損失。改善病患獲得瑞百安（Repatha）的途徑仍是我們團隊的首要任務。

Looking ahead to next year, we expect to begin tackling another significant unmet medical need in migraine. We're pleased to be pioneering the new CGRP class of medicines. We continue to receive positive feedback on Aimovig, and patients and physicians are excited on the prospects of a new, safe and effective preventative therapy. And that's exactly what we expect to deliver with Aimovig.

展望明年，我們預計將開始著手解決偏頭痛領域另一個尚未滿足的重大醫療需求。我們很高興能夠率先研發新型 CGRP 類藥物。我們不斷收到關於 Aimovig 的正面回饋，患者和醫生都對這種新的、安全有效的預防療法的前景感到興奮。而這正是我們希望透過 Aimovig 來實現的。

Given our core capabilities in biologics, I think biosimilars will become an important growth driver for us, and we continue to make progress in this area. As has become increasingly apparent, achieving biosimilarity is challenging. Our expertise in biologics development and manufacturing is a clear differentiator. This quarter, we received our second biosimilar approval with MVASI, a biosimilar to Avastin. We've also submitted our biosimilar to Herceptin to regulators for review. And importantly, we gained clarity around the launch time lines for AMGEVITA, our HUMIRA biosimilar, including an opportunity to launch in Europe starting next year.

鑑於我們在生物製劑方面的核心能力，我認為生物相似藥將成為我們重要的成長動力，我們也將繼續在這個領域取得進展。越來越明顯的是，實現生物相似性是一項挑戰。我們在生物製劑研發和生產方面的專業知識是一項明顯的競爭優勢。本季度，我們獲得了第二個生物相似藥批准，即MVASI，它是Avastin的生物相似藥。我們也已將我們的赫賽汀生物相似藥提交給監管機構審查。更重要的是，我們明確了 AMGEVITA（我們的 HUMIRA 生物相似藥）的上市時間表，包括明年開始在歐洲上市的機會。

We expect our biosimilars business to be an attractive source of revenue growth for us and one from which we expect to earn a strong return on investment for our shareholders.

我們預期生物相似藥業務將成為我們極具吸引力的收入成長來源，並有望為股東帶來豐厚的投資回報。

We're taking steps to develop our pipeline to sustain long-term growth. In addition to pursuing Phase III trials for omecamtiv mecarbil in heart failure and, of course, CNP520 for Alzheimer's disease, we are excited about moving tezepelumab into Phase III for asthma. We have a leading position in the TSLP area, and we're excited about the prospects of treating a broader population of asthmatics than other biologics on the market who are in development. Sean will address this in more detail shortly.

我們正在採取措施發展我們的產品線，以維持長期成長。除了推進 omecamtiv mecarbil 治療心臟衰竭的 III 期試驗，以及 CNP520 治療阿茲海默症的 III 期試驗之外，我們還很高興地宣布 tezepelumab 進入治療氣喘的 III 期試驗。我們在 TSLP 領域處於領先地位，我們對治療比市場上其他正在研發的生物製劑更廣泛的氣喘患者群體的前景感到興奮。肖恩稍後會更詳細地談到這一點。

Let me just say a few words about our manufacturing operations in Puerto Rico following the recent direct hit of Hurricane Maria on the island. Amgen has more than 2,000 staff members in Puerto Rico, and I'm delighted to report that all of our staff are accounted for and nearly all of our staff are now back at work. In fact, just 5 weeks after experiencing what was a 100-year storm, we have substantially resumed operations, serving patients in Puerto Rico and around the world.

鑑於颶風瑪莉亞最近正面襲擊了波多黎各島，我想就我們在波多黎各的生產營運情況簡單談幾句。安進在波多黎各擁有 2000 多名員工，我很高興地報告，我們所有的員工都已找到，幾乎所有員工現在都已返回工作崗位。事實上，在經歷了百年一遇的風暴後僅 5 週，我們就已基本恢復運營，為波多黎各和世界各地的患者提供服務。

While we did experience some damage in Puerto Rico, generally speaking, our facilities weathered the storm well and are in relatively good shape. As we've said before, we expect no impact to product supply for patients around the world, a real tribute to our team on the island and to all those at Amgen who have been working together to help us manage through these challenging circumstances. We appreciate the FDA's focus on Puerto Rico while the island recovers, and we've also been reaching out to many other pharmaceutical and medical device companies on the island to see if there are things that we can do collectively to help Puerto Rico get back on its feet as quickly as possible. We will continue to provide updates on this situation as appropriate.

雖然我們在波多黎各遭受了一些損失，但總的來說，我們的設施經歷了風暴的考驗，目前狀況良好。正如我們之前所說，我們預計不會對全球患者的產品供應造成任何影響，這要歸功於我們在島上的團隊以及安進公司所有齊心協力幫助我們應對這些挑戰的人。我們讚賞 FDA 在波多黎各災後重建期間對該島的關注，我們也一直在與島上許多其他製藥和醫療器材公司聯繫，看看我們是否可以共同做些什麼來幫助波多黎各盡快恢復正常運作。我們將根據情況繼續提供最新資訊。

Before I turn to David, let me just say that all in all, we feel we're in a strong position. We feel that we've positioned the company for the moment that we find ourselves in, as reflected in our balance sheet, which is very strong, as reflected in the cash flows that you see in our business and as reflected in our ongoing tight control of expenses.

在我把話轉給大衛之前，我想先說一句，總的來說，我們感覺我們處於有利地位。我們認為，我們已經為公司目前的處境做好了充分準備，這體現在我們非常強勁的資產負債表上，也體現在我們業務的現金流上，以及我們持續嚴格的費用控制上。

As we look to the future, we feel we have improved clarity on our opportunities for 2018 and beyond with the inclusion, obviously, of Repatha outcomes data in our label, which we think is set to happen in a matter of weeks; the prospect, as I've already mentioned, of launching our first-in-class migraine therapy Aimovig; clarity around prospective launch of Parsabiv in the U.S. for patients with kidney disease; 2 new opportunities for our denosumab franchise, including for glucocorticoid-induced osteoporosis for Prolia; and for multiple myeloma for XGEVA.

展望未來，隨著 Repatha 療效數據納入藥品標籤（我們認為這將在幾週內實現），我們對 2018 年及以後的發展機會有了更清晰的認識；正如我之前提到的，我們有望推出首創的偏頭痛療法 Aimovig；Parsabiv在美國上市治療腎臟病患者的前景也更加明朗；此外，我們的地諾單抗產品線也迎來了兩個新機遇，包括用於治療糖皮質激素引起的骨質疏鬆症的 Prolia，以及用於治療多發性骨髓瘤的 XGEVA。

We're also encouraged to have clarity now around our biosimilar franchise with, as I said a moment ago, a clear path for launching AMGEVITA internationally in 2018. And finally, following our great success with Onpro for Neulasta, we're excited to be introducing our new AutoTouch injector for Enbrel as well.

我們也感到鼓舞，因為我們的生物相似藥產品線現在有了清晰的規劃，正如我剛才所說，AMGEVITA 將於 2018 年在國際上推出，我們有了明確的路徑。最後，繼我們為 Neulasta 開發的 Onpro 取得巨大成功之後，我們很高興地推出我們為 Enbrel 開發的新型 AutoTouch 注射器。

With that, let me turn to David.

接下來，讓我把話題轉向大衛。

Okay. Thanks, Bob. We are pleased with our solid overall results and earnings growth in the third quarter as our transformation efforts continue to enable investment in our core business while also delivering operating leverage in a period of portfolio transition. I also want to take a moment to provide an update from a financial perspective on our Hurricane Maria recovery efforts at our Puerto Rican manufacturing facilities.

好的。謝謝你，鮑伯。我們對第三季穩健的整體績效和獲利成長感到滿意，因為我們的轉型努力持續推進，在投資組合轉型期間，既能對核心業務進行投資，又能實現營運槓桿效應。我也想藉此機會從財務角度介紹我們在波多黎各製造工廠應對颶風瑪莉亞災後重建工作的最新進展。

First off, I want to recognize the staff for their tireless efforts, which have ensured our patients a stable supply of Amgen's medicines even in the face of devastating personal loss and disruption across the island. As Bob mentioned, while we did experience some damage, all things considered, we weathered the storm in relatively good shape. Consistent with our approach to all other aspects of our business, we hold ourselves accountable for managing a disciplined and effective recovery effort. We incurred $67 million of pretax expenses or $0.07 a share in non-GAAP earnings in the third quarter related to inventory, idled facilities, repairs and support for our Puerto Rican staff.

首先，我要感謝全體員工的不懈努力，即使在全島遭受毀滅性的個人損失和混亂的情況下，他們也確保了安進公司藥品的穩定供應。正如鮑伯所說，雖然我們確實遭受了一些損失，但總的來說，我們相對來說比較順利地度過了這場風暴。與我們對待業務其他所有方面的態度一致，我們對管理有條不紊、卓有成效的恢復工作負責。第三季度，我們產生了 6,700 萬美元的稅前支出，相當於每股非 GAAP 收益 0.07 美元，這些支出與庫存、閒置設施、維修以及對我們波多黎各員工的支持有關。

In the fourth quarter, the company expects our manufacturing facility recovery effort to drive pretax expenses in the range of $75 million to $100 million or $0.08 to $0.11 a share.

該公司預計，第四季度製造工廠的復甦工作將導致稅前支出增加 7,500 萬美元至 1 億美元，即每股 0.08 美元至 0.11 美元。

At this time, we do not expect the recovery to have a significant impact on our full year 2018 results. We will provide further detail when we share our 2018 guidance in January. We are working with our insurance providers, but these estimates do not yet include insurance recoveries.

目前，我們預期經濟復甦不會對我們 2018 年全年業績產生重大影響。我們將在1月發布2018年業績指引時提供更多細節。我們正在與保險公司協商，但這些估算尚未包括保險賠償。

Turning to the financial results on Page 6 of the slide deck. Worldwide revenues at $5.8 billion in the third quarter are flat year-over-year excluding the impact of foreign exchange and are 1% lower on a reported basis including FX. This quarter, we saw worldwide product sales at $5.5 billion, also flat year-over-year excluding the impact of foreign exchange and 1% lower on a reported basis including FX.

接下來請看投影片第6頁的財務表現。第三季全球營收為 58 億美元，不計匯率影響與去年同期持平；若計入匯率影響，則較去年同期下降 1%。本季度，全球產品銷售額為 55 億美元，不計外匯影響與去年同期持平，但計入外匯影響後年減 1%。

Strong unit demand growth for our newer products was offset by declines in our mature brands. Other revenues at $320 million grew 8% versus the third quarter of 2016, driven by higher Ibrance royalty revenue.

雖然新產品的銷售需求強勁成長，但成熟品牌的銷售下滑抵消了這一成長。其他收入為 3.2 億美元，比 2016 年第三季增長 8%，主要得益於 Ibrance 特許權使用費收入的增加。

Non-GAAP operating income at $3 billion grew 4% from the prior year. Non-GAAP operating margin improved by 2.7 points to 55.6% for the quarter, reflecting continued favorable expense impacts from our transformation initiatives across all operating expense categories and the expiry of the Enbrel residual royalty payment.

非GAAP營業收入為30億美元，較上年成長4%。本季非GAAP營業利潤率提高了2.7個百分點，達到55.6%，這反映了我們轉型計劃在所有營運費用類別中持續帶來的有利費用影響，以及Enbrel剩餘特許權使用費的到期。

As in prior years, our operating margin is expected to be lower in the fourth quarter of the year, driven by the timing of expenses with the compare this year being especially challenged due to the $75 million to $100 million of incremental charges related to our hurricane recovery efforts. We will also pass the 1-year mark since the expiry of the Enbrel residual royalty payment at the end of October.

與往年一樣，由於費用發生的時間安排，預計今年第四季度的營業利潤率將有所下降，而今年由於與颶風災後重建工作相關的 7500 萬至 1 億美元的額外費用，今年的比較尤其具有挑戰性。到 10 月底，Enbrel 剩餘特許權使用費到期也已滿一年。

On a non-GAAP basis, cost of sales as a percent of product sales increased by 0.5 points to 13.5%, driven primarily by the impact of Hurricane Maria on our Puerto Rican operations, offset partially by manufacturing efficiencies and reduced royalties.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比上升了0.5個百分點，達到13.5%，這主要是由於颶風瑪麗亞對我們在波多黎各的業務造成了影響，部分被生產效率的提高和特許權使用費的減少所抵消。

Research and development expenses at $858 million were down 11% year-over-year, driven by several upfront payments for in-licensing transactions in Q3 of 2016, lower spending required to support certain later-stage clinical programs and continued benefits from transformation initiatives and process improvement efforts.

研發費用為 8.58 億美元，年減 11%，主要原因是 2016 年第三季支付了幾筆引進許可交易的預付款，支持某些後期臨床項目所需的支出減少，以及轉型計畫和流程改善工作帶來的持續效益。

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

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

In aggregate, non-GAAP operating expenses decreased 5% year-over-year, reflecting additional transformation savings while investing to build the business globally, support new product launches and investing in the long-term pipeline for the business.

整體而言，非GAAP營運費用年減5%，這反映出在投資拓展全球業務、支援新產品上市以及投資業務長期發展管道的同時，也實現了額外的轉型節省。

Other income and expenses were a net $58 million expense in Q3. This is favorable by $51 million on a year-over-year basis, primarily driven by higher cash balances and gains from our venture investment portfolio.

第三季其他收入和支出淨額為 5,800 萬美元。與去年同期相比，這帶來了 5,100 萬美元的收益，主要得益於現金餘額增加以及創投組合的收益。

The non-GAAP tax rate was 19.4% for the quarter, a 0.5 point increase versus the third quarter of 2016. This increase was primarily due to adjustments to certain federal tax credits and deductions, offset partially by favorable changes in the geographic mix of earnings.

本季非GAAP稅率為19.4%，較2016年第三季成長0.5個百分點。這一增長主要是由於某些聯邦稅收抵免和扣除的調整，但部分被收入地域構成有利的變化所抵消。

Non-GAAP net income increased 5% and non-GAAP earnings per share increased 8% year-over-year for the third quarter to $3.27 per share.

第三季非GAAP淨利年增5%，非GAAP每股盈餘較去年同期成長8%，達到每股3.27美元。

Turning next to cash flow and the balance sheet on Page 7. Free cash flow was $3.3 billion for the quarter compared to free cash flow of $2.5 billion in the third quarter of 2016, driven by improved collections and lower cash expenditures. We continue to provide significant cash returns to shareholders, consistent with our commitments as we deployed $0.8 billion to repurchase 4.4 million shares at an average of $177 per share and are on track to achieve our total share repurchases for this year in the range of $2.5 billion to $3.5 billion. Additionally, our third quarter dividend of $1.15 per share is an increase of 15% over last year. This reflects our balanced approach to capital allocation with significant investment in innovation in support of the long-term growth of the business as well as return of cash to shareholders.

接下來，請看第 7 頁的現金流量和資產負債表。本季自由現金流為 33 億美元，而 2016 年第三季自由現金流為 25 億美元，主要得益於收款情況的改善和現金支出的減少。我們繼續向股東提供可觀的現金回報，這與我們的承諾相符，我們已投入 8 億美元以平均每股 177 美元的價格回購了 440 萬股股票，並且預計將實現今年 25 億至 35 億美元的股票回購總額目標。此外，我們第三季每股派息 1.15 美元，比去年同期成長 15%。這反映了我們在資本配置方面採取的平衡方法，即對創新進行大量投資以支持業務的長期成長，同時向股東返還現金。

We continue to maintain financial and strategic flexibility as a result of our strengthening balance sheet position. Cash and investments totaled $41.4 billion, an increase of $3.4 billion from the third quarter of last year. This increase reflects continued solid net cash flow generation. Our debt balance stands at $35.8 billion as of September 30, carrying a weighted average interest rate of 3.7% and leverage maturity of 12 years.

由於資產負債表狀況不斷改善，我們得以繼續保持財務和策略上的靈活性。現金及投資總額為 414 億美元，比去年第三季增加了 34 億美元。這一增長反映了淨現金流的持續穩健成長。截至9月30日，我們的債務餘額為358億美元，加權平均利率為3.7%，槓桿期限為12年。

Turning to the outlook for the business for the remainder of 2017 on Page 8. Overall, our revised 2017 guidance range for revenue is $22.7 billion to $23 billion versus previous guidance of $22.5 billion to $23 billion. With regard to our non-GAAP earnings per share guidance, we are raising and narrowing the outlook to $12.50 to $12.70 per share. Our improved 2017 guidance reflects our continued conviction in our strategy as well as business performance over the first 3 quarters of the year. As a reminder, we expect to see an increase in operating expenses in Q4 versus Q3, reflecting the typical pattern for the business. Also included in this guidance is an incremental $75 million to $100 million of expenses related to Hurricane Maria recovery in the fourth quarter. Further, we are revising our non-GAAP tax guidance to 18% to 19% versus prior guidance of 18.5% to 19.5%. We continue to expect capital expenditures of approximately $700 million this year.

接下來請看第 8 頁，了解 2017 年剩餘時間的業務展望。整體而言，我們修訂後的 2017 年營收預期範圍為 227 億美元至 230 億美元，而先前的預期為 225 億美元至 230 億美元。關於我們的非GAAP每股盈餘預期，我們將預期範圍上調至每股12.50美元至12.70美元。我們上調了 2017 年業績預期，這反映了我們對自身策略的持續信心，以及今年前三個季度的業務表現。再次提醒，我們預計第四季度的營運費用將比第三季度增加，這反映了該業務的典型模式。該指導方針還包括第四季度與颶風瑪莉亞災後重建相關的額外 7,500 萬至 1 億美元的支出。此外，我們將非GAAP稅務預期從先前的18.5%至19.5%調整為18%至19%。我們預計今年的資本支出仍約為7億美元。

In summary, our 2017 performance remains on track as we continue to invest to grow the business while transforming to a more efficient operating model. We will provide 2018 guidance on our January call.

總而言之，隨著我們持續投資發展業務並轉型為更有效率的營運模式，我們 2017 年的表現仍保持在正軌上。我們將在1月份的電話會議上提供2018年的指導。

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

財務更新到此結束。現在我把電話交給東尼。

Thank you, David, and good afternoon, folks. You'll find the details of revenue starting on Slide #10 of your deck. Strong and continued volume growth by Prolia and our more recently launched brands like Repatha, KYPROLIS and BLINCYTO helped offset declines in our mature brands. Excluding the impact of foreign exchange, sales growth was flat year-over-year as reported sales declined 1%. The U.S. declined 2% year-over-year, and sales outside the U.S. grew 5% excluding the impact of foreign exchange, driven by a robust 8% volume growth.

謝謝你，大衛，各位下午好。您可以在簡報的第 10 張投影片中找到收入詳情。Prolia 和我們最近推出的品牌（如 Repatha、KYPROLIS 和 BLINCYTO）的強勁且持續的銷售成長，有助於抵消我們成熟品牌的下滑。剔除匯率影響，銷售額較去年同期持平，報告銷售額下降 1%。美國市場年減 2%，而美國以外地區的銷售額在不計匯率影響的情況下成長了 5%，這主要得益於銷量強勁成長 8%。

Let me start with Prolia. Prolia continues to deliver exceptional performance after being on the market for over 7 years. Prolia grew 22% year-over-year with double-digit volume growth in all markets, primarily from share gains. Quarter-on-quarter, we saw a slight decline, which follows the typical pattern for Prolia in the first and the third quarters. Prolia, as Bob said, is a unique asset with a very strong value proposition. There remains a large underserved osteoporotic population at risk for fracture. These fractures often cause loss of independence for patients and place a large burden on caregivers and society. We remain focused on improving diagnosis and treatment rates in order to bring Prolia to more of these patients in need. With share around 20% in most markets, there continues to be a lot of room for Prolia to grow, and we are investing accordingly.

讓我先從Prolia說起。Prolia上市7年多來，一直保持著卓越的性能。Prolia 年增 22%，所有市場的銷售量均達到兩位數成長，主要得益於市佔率的提升。與上一季相比，我們看到略有下降，這符合 Prolia 在第一季和第三季的典型模式。正如鮑伯所說，Prolia 是一項獨特的資產，具有非常強大的價值主張。仍有大量骨質疏鬆症患者未充分治療，面臨骨折風險。這些骨折往往會導致患者喪失獨立生活能力，並給照護者和社會帶來沉重的負擔。我們將繼續致力於提高診斷和治療率，以便讓更多有需要的患者能夠使用 Prolia。Prolia 在大多數市場佔有約 20% 的份額，仍有很大的成長空間，我們也正在相應地進行投資。

As I mentioned before, there are some countries, such as Australia, Switzerland and Ireland, with better diagnosis and treatment rates for osteoporosis where Prolia has a 50% share or better. These are countries that truly understand the societal cost of nonintervention.

正如我之前提到的，在某些國家，例如澳洲、瑞士和愛爾蘭，骨質疏鬆症的診斷和治療率較高，Prolia 在這些國家的市佔率達到 50% 或更高。這些國家真正了解不干預的社會代價。

KYPROLIS grew 13% year-over-year in the competitive multiple myeloma segment with several new entrants. Outside the U.S., we continue to see strong growth from both existing and new markets. KYPROLIS is a unique product in a competitive position, having 2 compelling sets of overall survival data in relapsed multiple myeloma patients. Our most recent market share data in the U.S. shows an improvement in new patient share in the second-line setting. This is an important leading indicator for sales growth in future quarters. KYPROLIS also continues to have a prominent position in the NCCN guidelines for all lines of therapy.

在競爭激烈的多發性骨髓瘤領域，KYPROLIS 年成長 13%，而該領域也湧現了許多新的競爭者。在美國以外，我們繼續看到現有市場和新市場都保持強勁成長。KYPROLIS 是一款獨特的產品，具有強大的競爭力，在復發性多發性骨髓瘤患者中擁有兩組令人信服的總生存期數據。我們最新的美國市場份額數據顯示，二線治療領域的新患者份額有所提高。這是未來幾季銷售成長的重要領先指標。KYPROLIS 在 NCCN 指南的所有治療方案中仍然佔有重要地位。

XGEVA declined 2% year-over-year, primarily due to a shift in timing of purchases from some larger end customers. We believe XGEVA is positioned for growth in 2018 with the addition of a multiple myeloma indication.

XGEVA較去年同期下降2%，主要原因是部分大型終端客戶的採購時間發生了變化。我們相信，隨著多發性骨髓瘤適應症的加入，XGEVA 將在 2018 年成長。

Neulasta declined 6% year-over-year due to a shift in timing of purchases by some larger end customers as well as a small decline in the number of myelosuppressive chemotherapy regimens.

由於一些大型終端客戶的採購時間發生了變化，以及骨髓抑制化療方案的數量略有下降，Neulasta 的銷量比去年同期下降了 6%。

The Onpro kit grew share to 56% of Neulasta units, and we expect to continue to drive additional Onpro adoption into 2018. Our most recent in-market data shows that Onpro drives better adherence to therapy, which leads to lowering of rates of febrile neutropenia, and in fact, lower rates of hospitalization. Simply put, Onpro is a better value to the health care system, and this is an important point of potential differentiation for the future.

Onpro 套件在 Neulasta 設備中的份額成長至 56%，我們預計在 2018 年將繼續推動 Onpro 的進一步普及。我們最新的市場數據顯示，Onpro 能提高病患對治療的遵從性，進而降低發燒性嗜中性白血球減少症的發生率，實際上還能降低住院率。簡而言之，Onpro 對醫療保健系統來說更有價值，這是未來潛在的重要差異化優勢。

With NEUPOGEN, the impact of short-acting biosimilar competition was consistent with prior trends. We exited the quarter with 41% share of the short-acting segment, and we have continued to maintain pricing discipline despite the competitive pressures NEUPOGEN has faced over the last several years.

對 NEUPOGEN 而言，短效生物相似藥競爭的影響與先前的趨勢一致。本季末，我們在短效藥市場佔有 41% 的份額，儘管 NEUPOGEN 在過去幾年中面臨激烈的競爭壓力，但我們仍然保持了定價紀律。

Enbrel sales declined 6% year-over-year, in line with prescription trends. We expect these prescription trends to continue into 2018. Segment growth year-over-year was in line with last quarter across both rheumatology and dermatology segments, confirming the rebound from the slower growth seen in quarter 1. Enbrel lost less than 1 point of share in both segments in this quarter, consistent with prior trends. Quarter 3 saw a low single-digit year-over-year decline in net selling price. Overall, we expect there to be a very slight year-over-year decline in net selling price for the full year 2017.

Enbrel 的銷售額年減了 6%，與處方趨勢一致。我們預計這些處方趨勢將持續到 2018 年。風濕病和皮膚病兩個細分市場的年成長率與上一季持平，證實了從第一季成長放緩的局面中反彈。本季度，恩利在兩個細分市場的市佔率均下降不到 1 個百分點，與先前的趨勢一致。第三季淨售價年減個位數百分比。總體而言，我們預計 2017 年全年淨售價將出現非常小的年減。

Most forming decisions for 2018 are now being finalized, and we expect the net selling price trends of 2017 to continue into 2018.

2018 年的大部分決策正在最終確定中，我們預計 2017 年的淨售價趨勢將延續到 2018 年。

You may recall that we noticed some potential excess end-user inventory at the end of quarter 2. End-user inventory levels are estimated by deducting the value prescriptions from the value of wholesaler shipments to end customers. Based on this data, we did not see a depletion in the third quarter. And if prior fourth quarter patterns hold, we would not expect a depletion in the fourth quarter either. We continue to make investments to maximize Enbrel's long-term value such as the imminent launch of our Enbrel AutoTouch, a reusable auto-injector that is ergonomically designed to meet the needs of rheumatoid arthritis patients.

您可能還記得，我們​​在第二季末注意到一些潛在的終端用戶庫存過剩。終端用戶庫存水準的估算方法是從批發商向終端客戶發貨的價值中減去處方價值。根據這些數據，我們沒有看到第三季出現損耗。如果以往第四季的模式保持不變，我們預期第四季也不會出現下滑。我們將繼續進行投資，以最大限度地提高恩利（Enbrel）的長期價值，例如即將推出的恩利自動注射器（Enbrel AutoTouch），這是一款可重複使用的自動注射器，其符合人體工學設計，旨在滿足類風濕性關節炎患者的需求。

Lastly, we look forward to extending our inflammation franchise into Europe next year with the launch of AMGEVITA, a biosimilar to HUMIRA.

最後，我們期待明年透過推出 AMGEVITA（一種 HUMIRA 的生物相似藥）將我們的發炎產品線擴展到歐洲。

Aranesp saw modest declined of 3% year-over-year. We had a small unfavorable impact in foreign exchange, and unit volume declined slightly globally.

Aranesp 年減 3%。我們在外匯方面受到了一些不利影響，全球銷量略有下降。

EPOGEN declined 21% year-over-year. The primary driver was lower net selling prices, in line with quarter 1 and quarter 2 as a result of our extended DaVita agreement. In the third quarter, we did not see any underlying changes in the EPOGEN business that have some unfavorable inventory changes, which added to the year-over-year decline.

EPOGEN年減21%。主要原因是淨售價下降，與第一季和第二季的情況一致，這是由於我們延長了與 DaVita 的協議。第三季度，我們沒有看到 EPOGEN 業務出現任何不利的庫存變化，這加劇了同比下降。

Sensipar increased 10% year-over-year, primarily due to net selling price.

Sensipar 年成長 10%，主要原因是淨售價上漲。

We've now launched Parsabiv in over 10 countries in Europe, and our partner-ONO has had a very successful launch in Japan. We are preparing to launch in the U.S. when CMS reimbursement code for Parsabiv becomes effective on January 1, 2018.

我們目前已在歐洲 10 多個國家推出了 Parsabiv，我們的合作夥伴 ONO 在日本的推出也非常成功。我們正準備在美國推出產品，屆時 CMS 對 Parsabiv 的報銷代碼將於 2018 年 1 月 1 日生效。

Now to Repatha. Our cardiovascular team continued its strong competitive execution, reaching 60% of total prescription share in the U.S. and 57% in the EU. In the U.S., new-to-brand share, which in my mind is a forecast of the future sales, in the U.S. reached 74%. Sequentially, our RXs grew by 20% in the U.S. However, sequential sales growth was tempered by changes in inventory and accounting adjustments that benefited the second quarter. We continue to work hard with payers to improve access for appropriate patients. And we look forward to the FDA's priority review of Repatha's cardiovascular outcomes data, which will allow us to start promoting Repatha's ability to reduce heart attacks and strokes with both physicians and patients in December this year.

現在來說說瑞帕塔。我們的心血管團隊持續保持強勁的競爭優勢，在美國的處方市佔率達到 60%，在歐盟達到 57%。在美國，新品牌份額（在我看來，這是對未來銷售的預測）達到了 74%。我們的處方藥在美國的銷售量較上季成長了 20%。然而，由於庫存變化和會計調整，第二季度的銷售額環比增長受到抑制。我們將繼續與支付方密切合作，努力改善符合條件的患者獲得醫療服務的途徑。我們期待 FDA 優先審查 Repatha 的心血管結果數據，這將使我們能夠從今年 12 月開始向醫生和患者宣傳 Repatha 降低心臟病發作和中風風險的能力。

Cardiovascular disease continues to be the #1 cause of death and disability in the world, and it's a top priority at Amgen to ensure that appropriate patients have access to Repatha.

心血管疾病仍然是全球死亡和殘疾的首要原因，安進公司的首要任務是確保合適的患者能夠獲得瑞百安（Repatha）。

So in conclusion, we are focused on a strong finish to 2017 as we prepare for numerous launches in 2018, which includes our Repatha outcomes label, the Enbrel AutoTouch device, Aimovig for migraine, Parsabiv, the XGEVA multiple myeloma indication as well as large opportunities from our biosimilar franchise.

總而言之，我們正全力以赴，力爭在 2017 年取得圓滿成功，並為 2018 年的眾多產品上市做好準備，其中包括 Repatha 的療效標籤、Enbrel AutoTouch 設備、用於治療偏頭痛的 Aimovig、Parsabiv、XGEVA 的多發性骨髓瘤適應症，以及我們生物類似藥產品線帶來的巨大藥物。

Let me for a moment stop and say thank you to all the Amgen staff who have worked so hard and tirelessly this quarter to get our important drugs to patients around the world.

請允許我停下來片刻，感謝安進公司全體員工在本季度辛勤工作，不懈努力，將我們重要的藥物送到世界各地的患者手中。

And now let me pass you to Sean. Sean?

現在讓我把麥克風交給肖恩。肖恩？

Thanks, Tony, and good afternoon. I'll begin with our cardiovascular therapeutic area. On Repatha, we continue to work with regulators towards incorporating cardiovascular outcomes data on our label, and we are looking forward to our PDUFA date of December 2. In September, the American College of Cardiology issued their updated expert consensus decision pathway for non statin therapies based largely on our cardiovascular outcomes data. It's clear that if these recommendations were followed in the United States, millions of patients would be treated with PCSK9 inhibitors. We also recently completed a Phase III Repatha LDL lowering study in diabetic patients, an important population at increased risk for cardiovascular disease. Repatha demonstrated efficacy and safety data consistent with that seen in our broader Repatha program, and we'll be presenting the results at an upcoming medical meeting.

謝謝你，托尼，下午好。我先從心血管治療領域說起。關於 Repatha，我們繼續與監管機構合作，將心血管結果數據納入我們的標籤，我們期待 12 月 2 日的 PDUFA 日期。 9 月，美國心臟學會發布了其更新的非他汀類藥物專家共識決策路徑，該路徑主要基於我們的心血管結果數據。很顯然，如果這些建議在美國被採納，數百萬名患者將接受 PCSK9 抑制劑治療。我們最近也完成了針對糖尿病患者的 Repatha LDL 降低 III 期研究，糖尿病患者是心血管疾病高風險族群。Repatha 的療效和安全性數據與我們更廣泛的 Repatha 計畫所取得的數據一致，我們將在即將舉行的醫學會議上發表這些結果。

After reviewing the recently presented outcomes data from Merck's CETP inhibitor, Anacetrapib, we feel the value of our CETP inhibitor, AMG 899, would be best realized through potential out-licensing opportunities, which we are exploring.

在審查了默克公司最近公佈的 CETP 抑制劑 Anacetrapib 的結果數據後，我們認為，透過潛在的對外授權機會，我們能夠最好地實現我們 CETP 抑制劑 AMG 899 的價值，而我們正在探索這些機會。

I'd also like to provide an update on one of our exciting Phase I cardiovascular programs, AMG 986. AMG 986 is a small molecule agonist of the apelin APJ receptor, which is associated with the body's biologics stress response to heart failure. Consistent with our strategies to pursue novel targets with human validation, administration of an endogenous peptide agonist of APJ has been shown to improve cardiac function in heart failure patients. Preclinical data support clinical testing in the setting of heart failure with both preserved and reduced ejection fraction. We're actively enrolling healthy volunteers in heart failure patients in Phase I and appear to be in a significant leading position around this exciting access.

我也想向大家介紹我們令人興奮的第一階段心血管計畫 AMG 986 的最新進展。AMG 986 是 apelin APJ 受體的小分子激動劑，該受體與身體對心臟衰竭的生物壓力反應有關。與我們追求具有人體驗證的新標靶的策略一致，已證明，施用 APJ 內源性勝肽激動劑可以改善心臟衰竭患者的心臟功能。臨床前數據支持在射血分數保留和射血分數降低的心臟衰竭患者中進行臨床試驗。我們正在積極招募健康志願者參與 I 期心臟衰竭患者研究，並且似乎在這一令人興奮的治療領域處於顯著的領先地位。

Turning to inflammation and our TSLP antibody, tezepelumab, which we're developing in collaboration with AstraZeneca. The results of a large Phase IIb study in patients with uncontrolled asthma were recently published and presented to a very enthusiastic response. TSLP is an upstream epithelial driver of inflammation in asthma. And the data supported the potential to address a broader population of patients, essentially all-comers, then targeting individual cytokines such as IL-4, 13 or IL-5. We're currently working with our partner and regulators on the design of our Phase III asthma program, and we'll provide updates as we progress.

接下來我們來談談發炎以及我們正在與阿斯特捷利康合作開發的 TSLP 抗體 tezepelumab。最近，一項針對未控制氣喘患者的大型 IIb 期研究結果已發表，並引起了非常熱烈的迴響。TSLP 是氣喘發炎的上游上皮驅動因素。數據表明，這種方法有可能惠及更廣泛的患者群體，基本上是所有患者，然後針對單一細胞因子，如 IL-4、IL-13 或 IL-5。我們目前正與合作夥伴和監管機構共同製定 III 期氣喘治療方案的設計，並將隨著進展提供最新資訊。

Finally, results from a small exploratory short-duration Phase 2a study of tezepelumab as an add-on treatment to medium and high-strength topical glucocorticoids in atopic dermatitis were recently posted. 111 patients with moderate to severe atopic dermatitis received 280 milligrams of tezepelumab or placebo every other week for 12 weeks. Statistical significance on the primary endpoint of 50% reduction in eczema area and severity index at 12 weeks was not achieved, though positive trends were observed across a number of disease activity endpoints, suggesting that tezepelumab may deliver clinical benefit as add-on treatments to topical glucocorticoids. The evaluation of tezepelumab in atopic dermatitis may require further study, and we continue to consider this indication, among others, in our life cycle development plan.

最後，最近公佈了一項小型探索性短期 2a 期研究的結果，該研究評估了 tezepelumab 作為中高強度局部糖皮質激素治療異位性皮膚炎的附加療法的療效。111 名中度至重度異位性皮膚炎患者每隔一週接受 280 毫克 tezepelumab 或安慰劑治療，持續 12 週。雖然在 12 週時濕疹面積和嚴重程度指數減少 50% 的主要終點未達到統計學意義，但在多個疾病活動終點中觀察到了積極的趨勢，這表明 tezepelumab 可作為局部糖皮質激素的附加治療帶來臨床益處。tezepelumab 在異位性皮膚炎中的療效評估可能需要進一步研究，我們將繼續在生命週期開發計劃中考慮此適應症以及其他適應症。

I'll begin my comments on our oncology efforts with KYPROLIS. In the second line of relapsed multiple myeloma setting, we now have an April 2018 PDUFA date for the ENDEAVOR overall survival data, and we're busy preparing a submission for the ASPIRE overall survival data. In frontline or newly diagnosed multiple myeloma, we're supporting high-quality evidence generation through randomized Amgen-supported studies, sponsored by investigators and large cooperative groups with a focus on the KRd regimen, KYPROLIS, Revlimid and dexamethasone. We're particularly interested and excited about the potential of KYPROLIS plus Darzalex and will begin to support KRd plus Darzalex study along with Janssen in the frontline transplant-eligible population to build on the ongoing Kd plus Darzalex study we're running with Janssen in the relapsed and refractory setting. We believe the combination of these 2 highly potent therapies could significantly improve patient outcomes and drive patients into deep, durable remissions.

我將首先就我們的腫瘤治療工作談談 KYPROLIS。在復發性多發性骨髓瘤的二線治療中，我們現在有 ENDEAVOR 總生存期數據的 PDUFA 日期（2018 年 4 月），我們正在忙於準備 ASPIRE 總生存期數據的提交。對於一線或新診斷的多發性骨髓瘤，我們正在透過安進支持的隨機研究來支持​​高品質的證據生成，這些研究由研究人員和大型合作組贊助，重點關注 KRd 方案、KYPROLIS、Revlimid 和地塞米松。我們對 KYPROLIS 加 Darzalex 的潛力特別感興趣和興奮，並將與 Janssen 一起開始支持 KRd 加 Darzalex 在一線移植適用人群中的研究，以建立在我們與 Janssen 在復發和難治性環境中正在進行的 Kd 加 Darzalex 研究的基礎上。我們相信，這兩種高效療法的結合可以顯著改善患者的治療效果，並使患者達到深度、持久的緩解。

Lastly on KYPROLIS, the Phase III ARROW study of KYPROLIS administered at 70 milligrams per meter squared weekly versus 27 milligrams per meter squared twice weekly in combination with dexamethasone met its progression-free survival primary endpoint at a prespecified 75% interim analysis by demonstrating superior efficacy of the 70-milligram weekly regimen with similar safety findings.

最後，關於 KYPROLIS，一項 III 期 ARROW 研究比較了每週每平方米 70 毫克 KYPROLIS 與每週兩次每平方米 27 毫克 KYPROLIS 與地塞米松聯合用藥的療效，結果在預先設定的 75% 中期分析中達到了無進展生存期的主要終點，證明每週 70 毫克安全方案相似。

Turning to our bispecific T-cell engager programs. We recently announced the collaboration with CytomX to expand our immuno-oncology capabilities with an additional and complementary bispecific technology. As part of the agreement, we will codevelop a T-cell engaging bispecific antibody against epithelial growth factor receptor, or EGFR, employing their Probody technology, and we also have exclusive rights to develop up to 3 additional undisclosed targets.

接下來，我們將介紹我們的雙特異性T細胞銜接器計畫。我們最近宣布與 CytomX 合作，利用額外的互補雙特異性技術來擴展我們的免疫腫瘤學能力。作為協議的一部分，我們將利用他們的Probody技術共同開發一種針對表皮生長因子受體（EGFR）的T細胞結合雙特異性抗體，我們還擁有開發至多3個其他未公開靶點的專屬權利。

In our BiTE platform, we have several extended half-life BiTEs moving into Phase I: AMG 673, directed against CD33 for AML; AMG 596 against EGFR variant III for glioblastoma; and AMG 701 against BCMA for multiple myeloma.

在我們的 BiTE 平台中，我們有幾種半衰期延長的 BiTE 進入 I 期臨床試驗：AMG 673，靶向 CD33 用於治療 AML；AMG 596，靶向 EGFR 變體 III 用於治療膠質母細胞瘤；以及 AMG 701，靶向 BCMA 用於治療多發性骨髓瘤。

Importantly, we have also seen data recently that markedly increase our confidence that BiTEs can have impressive activity in solid tumors.

重要的是，我們最近也看到了一些數據，這些數據顯著增強了我們對 BiTEs 在實體瘤中具有顯著活性的信心。

Turning to IMLYGIC, our oncolytic viral therapy. In collaboration with Toni Ribas at UCLA, we recently published positive clinical and impressive biomarker data from a Phase Ib melanoma study of IMLYGIC in combination with KEYTRUDA, a checkpoint inhibitor.

接下來我們來看看溶瘤病毒療法 IMLYGIC。我們與加州大學洛杉磯分校的 Toni Ribas 合作，最近發表了 IMLYGIC 與檢查點抑制劑 KEYTRUDA 聯合治療黑色素瘤的 Ib 期研究的積極臨床數據和令人印象深刻的生物標記數據。

To the best of our knowledge, these were the first clinical data published in The Journal Cell and generated much enthusiasm among clinical investigators. These results, along with our other Phase II data, both biomarker and clinical endpoints in combination with ipilimumab, add to the growing body of evidence supporting the systemic effect of IMLYGIC and its considerable potential for combination with checkpoint inhibitors.

據我們所知，這些是《細胞》雜誌上發表的首批臨床數據，引起了臨床研究人員的極大熱情。這些結果，連同我們其他的 II 期數據，包括生物標記和臨床終點與伊匹木單抗聯合應用的結果，進一步證實了 IMLYGIC 的全身作用及其與檢查點抑製劑聯合應用的巨大潛力。

A word on Aranesp, after many years of intense effort, our final postmarketing requirement study on tumor progression and overall survival has read out. This was a prospective 2,500 patient double-blind placebo-controlled study to evaluate the safety and efficacy of Aranesp in anemic populations with advanced non-small cell lung cancer receiving multicycle chemotherapy. Recall that this was one of the tumor types that had suggested potential tumor progression effects in a small study. The data monitoring committee determined that the primary endpoint would be met with near certainty and recommended that we stop the study early. After discussion with global regulators, we ended the study, and the data indeed showed that the primary endpoint of non inferiority of Aranesp to placebo in overall survival was successfully achieved as were the secondary endpoints of non inferiority to progression-free survival and non inferiority to objective tumor response. As expected, transfusions were lower in the Aranesp arm.

關於 Aranesp，經過多年的努力，我們關於腫瘤進展和總體生存期的最終上市後要求研究結果已經公佈。這是一項前瞻性的雙盲安慰劑對照研究，納入 2500 名患者，旨在評估 Aranesp 在接受多周期化療的晚期非小細胞肺癌貧血患者中的安全性和有效性。回想一下，這是在一項小型研究中顯示出可能對腫瘤進展產生影響的腫瘤類型之一。數據監測委員會認定主要終點幾乎肯定會達到，並建議我們提前停止研究。在與全球監管機構討論後，我們結束了這項研究，數據確實表明，Aranesp 在總生存期方面不劣於安慰劑的主要終點已成功實現，無進展生存期和客觀腫瘤反應方面不劣於安慰劑的次要終點也已成功實現。正如預期的那樣，Aranesp 組的輸血量較低。

In bone health, our Prolia submission for the treatment of glucocorticoid-induced osteoporosis is under review with a May 2018 PDUFA action date. Results of the Phase III ARCH study with romosozumab, or EVENITY, compared to alendronate in postmenopausal women with osteoporosis were recently published and presented. We continue to believe from our interactions with experts in the field and regulators that there may be a patient population at high risk for fractures for whom EVENITY could provide a positive benefit risk. And we're evaluating all of our Phase III clinical trial data to gain a comprehensive understanding of the cardiovascular safety results that were observed in ARCH, yet not observed in our placebo-controlled FRAME study.

在骨骼健康方面，我們用於治療糖皮質激素引起的骨質疏鬆症的 Prolia 申請正在接受審查，PDUFA 將於 2018 年 5 月做出決定。最近發表並公佈了 romosozumab（或 EVENITY）與阿崙膦酸鈉治療停經後骨質疏鬆症婦女的 III 期 ARCH 研究結果。我們透過與該領域專家和監管機構的交流，繼續相信可能有一部分骨折風險較高的患者群體，EVENITY 可以為他們帶來積極的獲益風險。我們正在評估所有 III 期臨床試驗數據，以全面了解在 ARCH 研究中觀察到的、但在安慰劑對照的 FRAME 研究中未觀察到的心血管安全性結果。

In our neuroscience collaboration with Novartis, we recently presented the results from a unique dedicated study that demonstrated that Aimovig did not aggravate ischemia in patients with stable angina, contributing further to the growing body of evidence supporting the safety profile of CGRP receptor inhibition with Aimovig.

在我們與諾華的神經科學合作中，我們最近公佈了一項獨特的專案研究的結果，該研究表明 Aimovig 不會加重穩定型心絞痛患者的缺血症狀，進一步為支持 Aimovig 抑制 CGRP 受體安全性的證據庫做出了貢獻。

In our second migraine program, I am pleased to report we're currently enrolling migraine patients now in a Phase IIb study of our PAC1 antibody AMG 301. PAC1 inhibition is a novel approach to migraine prevention that is mechanistically differentiated from the CGRP pathway.

我很高興地報告，在我們的第二個偏頭痛計畫中，我們目前正在招募偏頭痛患者參與我們的 PAC1 抗體 AMG 301 的 IIb 期研究。PAC1 抑制是一種預防偏頭痛的新方法，其機制與 CGRP 路徑不同。

And finally, I'd like to highlight our second U.S. biosimilar approval, in this case, for all eligible indications of Avastin; and the U.S. submission of ABP 980, our biosimilar, Herceptin. Achieving biosimilarity in the U.S. regulatory environment has turned out to be more challenging than many expected, and our continued success is a testament to our unsurpassed biologics development and manufacturing capabilities.

最後，我想重點介紹我們第二個在美國核准的生物類似藥，這次是針對阿瓦斯汀所有符合條件的適應症；以及我們向美國提交的生物類似藥 ABP 980（赫賽汀）的上市申請。在美國監管環境下實現生物相似性比許多人預期的更具挑戰性，而我們持續的成功證明了我們無與倫比的生物製劑開發和生產能力。

As always, I'd like to thank all of the staff at Amgen that make it possible to wage war against the worst forms of disease.

一如既往，我要感謝安進公司的所有員工，正是他們的努力使得我們能夠對抗最嚴重的疾病。

Bob?

鮑伯？

Okay, thank you, Sean. Ian, can we open up the lines for questions now? And would you remind our callers of the process?

好的，謝謝你，肖恩。伊恩，現在可以開始接受提問了嗎？您能否提醒一下來電者相關流程？

(Operator Instructions) Our first question is from Chris Raymond from Piper Jaffray.

（操作說明）我們的第一個問題來自 Piper Jaffray 公司的 Chris Raymond。

So just a question on the Neulasta Onpro Kit, if you don't mind. Noticing that quarter-on-quarter share ticked up about 1%, it looks like, to 56%. I think that's a little bit of a leveling off from what you've seen in previous quarters. Just wondering if you could maybe comment on what you think a steady-state share would be for that presentation of the product ahead of any biosimilar in Neulasta launch?

如果您不介意的話，我想問一個關於Neulasta Onpro套件的問題。注意到季度環比份額似乎小幅上升了約 1%，達到 56%。我認為這比前幾季的情況略有趨於平穩。我想請問您能否就該產品在Neulasta生物相似藥上市前的穩定市佔率發表一下看法？

So Chris, this is Tony. Clearly, I am not happy with 56%. If I look at the product value that this thing brings in terms of enhancing patient's ability to go home, the value to a large institution in terms of how they treat patients, we will continue to drive hard to increase that share beyond 56%.

克里斯，這位是東尼。顯然，我對56%這個結果並不滿意。如果我審視該產品在提高患者出院能力方面的價值，以及它對大型醫療機構在治療患者方面的價值，我們將繼續努力，使市場份額超過 56%。

And our next question is from the line of Geoffrey Porges from Leerink Partners.

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

A question for David. Look, you highlighted the operating margin uptick in the quarter and then the potential step-down in Q4. But as you look ahead, you must have gone through your sort of long-range planning exercise, David, how do things look in terms of your ability to maintain those operating margins as you change the mix of products and pivot over to partnerships and collaborations? Is this 55% looking sustainable to you? Or should we be anticipating that there'll be some reduction over the next few years?

問大衛一個問題。你看，你強調了本季營業利潤率的成長，以及第四季可能出現的下滑。但展望未來，大衛，你肯定已經進行過某種長期規劃了，隨著你改變產品組合併轉向合作關係，你認為你維持這些營運利潤率的能力如何？你覺得55%的比例可持續嗎？或者我們應該預期未來幾年會出現一些減少？

Sure. So yes, so if you recall, we set out a plan for the company a few years ago to get to 52% to 54% objective by 2018. And the good news for the company is we've been able to certainly move that forward and achieve that type of performance upwards to a year in advance of our original goal. So we've been quite pleased with our ability to deliver on that performance. And I think, importantly, during the period, while we were accomplishing that, we've had record levels of investment in R&D, we've stood up a cardiovascular franchise, we're about to stand up a neuro franchise here next year, built the biosimilars business and increased our footprint from 50 to 100 countries. So if I look at that performance and I look at our ability to continue to invest, I think it's quite encouraging. And while we haven't given guidance post-2018 yet, I think suffice to say, we feel very good about the sustainability of that type of margin performance for the company.

當然。是的，如果你還記得的話，幾年前我們為公司製定了一個計劃，目標是在 2018 年達到 52% 到 54% 的目標。對公司來說，好消息是我們已經能夠推進這項工作，並提前一年實現了我們原定目標的業績。因此，我們對自身的表現能力感到非常滿意。而且我認為，更重要的是，在此期間，在我們實現這些目標的同時，我們在研發方面投入了創紀錄的資金，我們建立了心血管特許經營權，明年我們將在這裡建立一個神經特許經營權，建立了生物類似藥業務，並將我們的業務範圍從 50 個國家擴大到 100 個國家。所以，如果我看一下業績，再看看我們繼續投資的能力，我認為這相當令人鼓舞。雖然我們尚未給出 2018 年以後的業績指引，但我認為可以肯定的是，我們對公司這種利潤率表現的可持續性感到非常樂觀。

And our next question is from the line of Matthew Harrison from Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

A 2-parter for me on Repatha. I guess, maybe could you comment on what your view is on the market share for that product going forward? Obviously, you pointed to NBRxs that are quite high, though your competitor products obviously may remain on the market longer than you originally thought. And then any comments on how formularies for Repatha are shaping up into 2018?

對我來說，關於Repatha的文章分為兩個部分。我想，您能否談談您對該產品未來市佔率的看法？顯然，你指出的 NBRx 值相當高，儘管你的競爭對手的產品顯然可能會比你最初預想的在市場上停留更長時間。那麼，對於Repatha公司2018年的藥品目錄制定狀況，您有什麼看法？

Okay. Matt, so it's Tony. Let me respond there. So the market share we've achieved to date has been in the presence of a competitor. So as I think about going forward, we will continue to be competitive. And I think getting more and more patients on Repatha is our objective, which we've been quite successful with. We are working extensively with the payers at the moment in terms of improving potentially the utilization management criteria and working on trying to reduce the onerous bureaucracy that takes place and frustrate physicians at the moment. We look forward to being able to pull some of these things through potentially in 2018.

好的。馬特，原來是東尼。我稍後會在那裡回覆。因此，我們迄今為止所取得的市佔率都是在有競爭對手的情況下取得的。所以展望未來，我們將持續保持競爭力。我認為讓越來越多的患者使用瑞百安是我們的目標，而我們在這方面也取得了相當大的成功。目前，我們正在與支付方廣泛合作，以期改善利用管理標準，並努力減少目前令醫生感到沮喪的繁瑣官僚程序。我們期待在 2018 年實現其中一些目標。

And our next question is from the line of Terence Flynn from Goldman Sachs.

下一個問題來自高盛的 Terence Flynn。

I was just wondering, Bob, if you could just give us your view on tax reform as we head into 2018? I know there's a lot of moving pieces there, but do you anticipate that Puerto Rico would still be advantaged relative to the U.S.? And then on the capital allocation front, how do you think about the potential for use of capital if you -- if there is a repatriation allowed under the deal?

鮑勃，我只是想問你，在即將進入2018年之際，你能不能談談你對稅制改革的看法？我知道這裡面有很多變數，但你認為波多黎各相對於美國仍然具有優勢嗎？那麼在資本配置方面，如果協議允許資金匯回，您如何看待資本的潛在用途？

Sure, Terence. Thanks for the question. Obviously, we think tax reform makes sense for the country. We've been advocating for that for some time. We continue to advocate for it and continue to advocate for the need for that tax reform to reflect the reality in Puerto Rico, which is that a number of organizations, including Amgen, have major investments in Puerto Rico that were made there to capitalize on the tax advantages created by U.S. laws. So we're keen to see that as tax reform plays out, the important role of manufacturing in the island is reflected and that the appropriate language is included in the tax reform to continue to maintain the incentive for us and others to invest on the island. So we're watching the process closely, Terence. And interested, no doubt all of you are, to see exactly how language will be written to address the needs in Puerto Rico. And then more broadly on capital allocation, obviously, we have a track record of returning significant capital to our shareholders. And to the extent that tax reform happens and provides greater flexibility for us, we'll take that into account in our capital allocation plans. But as you know, from our track record over the last many years, we've been actively returning capital in the form of growing dividend and buyback, and I would expect us to continue that.

當然可以，特倫斯。謝謝你的提問。顯然，我們認為稅制改革對國家來說是有意義的。我們一直以來都在倡導這一點。我們繼續倡導這項改革，並繼續倡導進行稅收改革的必要性，以反映波多黎各的現實情況，即包括安進在內的許多組織在波多黎各進行了大量投資，這些投資是為了利用美國法律創造的稅收優勢。因此，我們熱切希望看到，隨著稅制改革的實施，製造業在島上的重要作用能夠得到體現，並且稅制改革中能夠包含適當的措辭，以繼續保持我們和其他人在島上投資的動力。所以，特倫斯，我們正在密切關注這個過程。毫無疑問，你們都很有興趣看看究竟會如何寫語言來滿足波多黎各的需求。更廣泛地說，就資本配置而言，顯然，我們有向股東返還大量資本的良好記錄。如果稅制改革得以實施，並為我們提供了更大的靈活性，我們將在資本配置計畫中考慮這一點。但正如您所知，從我們過去多年的業績來看，我們一直在積極地透過提高股息和股票回購來回報資本，我希望我們能夠繼續這樣做。

And our next question is from the line of Robyn Karnauskas from Citi.

下一個問題來自花旗銀行的 Robyn Karnauskas。

So you kind of had a lot of success getting biosimilars approved and through. There's been a lot of other rejections or delays. And we have noted that NEUPOGEN really was impacted by biosimilars while REMICADE was not. So I was just wondering if you could help us understand, given what you've seen in the biosimilar space, how to think about -- how you will launch your biosimilars. How do we think about the REMICADE analogy and the NEUPOGEN analogy and how to model your biosimilar business?

所以你們在生物相似藥的審批和上市方面取得了很大的成功。還有許多其他的拒絕或延誤。我們注意到，NEUPOGEN確實受到了生物相似藥的影響，而REMICADE則沒有。所以我想問您，鑑於您在生物相似藥領域所看到的，您能否幫助我們理解一下，您將如何考慮——如何推出您的生物類似藥。我們如何看待 REMICADE 的類比和 NEUPOGEN 的類比，以及如何建立您的生物相似藥業務模型？

Okay. Robyn, I'll ask Tony to comment on the specifics of how we're looking at going to market. But your general point is noted. It has proven difficult for our competitors to get biologics approved and biosimilars approved on time. And we're not fully surprised by that. We expected that there would be difficulties, and we expected that the capabilities we had will be helpful for us to differentiate versus some of our competitors, and I think that's what's playing out. But I think the gist of your question about how we're planning to go to market is one for Tony to address.

好的。羅賓，我會請托尼就我們計劃如何進入市場的具體細節發表意見。但你的觀點我已記住。事實證明，我們的競爭對手很難按時獲得生物製劑和生物相似藥的批准。我們對此並不感到完全意外。我們預料到會遇到困難，也預料到我們擁有的能力將有助於我們與一些競爭對手區分開來，我認為現在的情況正是如此。但我認為，你提出的關於我們計劃如何進入市場的問題，應該由東尼來回答。

Okay. So Robyn, clearly, we think that the market in the beginning will be a branded biosimilar market. And therefore, the value we bring as an organization about the quality and the continuity of our supply is really important. The relationships we have with large institutions, with small community clinics is really going to be important as well. So we will focus very clearly on our relationships of the past, our skills of the past as well as the value of the product we bring to market.

好的。所以羅賓，很顯然，我們認為最初的市場將是一個品牌生物相似藥市場。因此，我們作為一家企業，在品質和供應連續性方面所帶來的價值非常重要。我們與大型機構以及小型社區診所的關係也至關重要。因此，我們將非常明確地關注我們過去的人際關係、我們過去的技能以及我們推向市場的產品的價值。

And our next question is from the line of Ying Huang from Bank of America Merrill Lynch.

下一個問題來自美國銀行美林證券的黃穎。

I have one on Enbrel maybe for Tony. So one, I'm curious on your comment that you do not expect further depletion of Enbrel inventory in Q4. And I was wondering why that could be. And then secondly, can you comment on 2018 net pricing trend for Enbrel now that we're kind of like late 2017 already?

我這裡有一份關於恩利（Enbrel）的處方，或許可以給托尼用。首先，我對您所說的「預計第四季度 Enbrel 庫存不會進一步減少」的評論感到好奇。我想知道這是為什麼。其次，現在差不多已經是 2017 年底了，您能否談談 2018 年 Enbrel 的淨價趨勢？

Okay, Ying. So as I've said, the end-user inventory is a triangulation we do in an attempt to give you guys as much visibility as possible about what we know to allow you to run your models. But fundamentally, we do the calculation based on what the RXs are in the marketplace, which are never 100%, minus what we know our wholesalers sold to the end users, and the balance we assume is an inventory build. When I look back 5 years, I've never seen an inventory burn in the fourth quarter, so we're making the assumption that there wouldn't be an inventory burn this fourth quarter as well. As regards to 2018, as I said to my earlier comments, most of our contracts have been negotiated, although that doesn't mean that there won't be negotiations that continue going forward during 2018. But we do expect the net selling price for Enbrel -- the trend you've seen in 2017, we expect that to continue into 2018.

好的，穎。正如我之前所說，最終用戶庫存是我們透過三角測量法來嘗試盡可能地向你們展示我們所掌握的信息，以便你們能夠運行自己的模型。但從根本上講，我們是根據市場上的處方藥數量（永遠不會達到 100%）進行計算的，減去我們知道的批發商賣給最終用戶的數量，剩下的部分我們假設為庫存增加。回顧過去 5 年，我從未見過第四季度出現庫存消耗，因此我們假設今年第四季也不會出現庫存消耗。至於 2018 年，正如我之前所說，我們的大部分合約已經談判完成，但這並不意味著 2018 年不會繼續進行談判。但我們預計 Enbrel 的淨售價——您在 2017 年看到的趨勢——將延續到 2018 年。

And our next question is from the line of Eric Schmidt from Cowen and Company.

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

It's on Sensipar and Parsabiv. I guess, first, are we expecting generic Sensipar in March of next year? Or were you able to extend pediatric exclusivity, I think, is what you're looking for, for another 6 months? And second, can Tony talk a little bit about the switching strategy to Parsabiv starting January 1?

它出現在 Sensipar 和 Parsabiv 上。首先，我想問的是，我們是否可以期待明年三月上市仿製版Sensipar？或者，您是否能夠將兒科獨家銷售權再延長 6 個月？我想，這才是您想要的。其次，Tony 能否談談從 1 月 1 日起轉向 Parsabiv 的策略？

So let me just take your question on Sensipar and then, Tony, you talk about Parsabiv. We have litigation, as you know, Eric, underway regarding the pediatric extension, so I don't want to comment on that while the litigation is pending. But Tony, why don't you talk about Parsabiv?

那麼，我就先回答你關於 Sensipar 的問題，然後，Tony，你來談談 Parsabiv。正如你所知，埃里克，我們正在就兒科延期問題進行訴訟，所以在訴訟進行期間，我不想對此發表評論。但是托尼，你為什麼不談談帕薩比夫呢？

So we are bringing Parsabiv to market based on the clinical data we have at present, right? So by definition, secondary HPT is a very difficult thing to treat, and adherence is a real problem. I think we have about 150,000 patients on the drug at the moment, which is only about a 26% penetration. The head to head data we have as shown great levels of efficacy in Parsabiv. And without a doubt in our mind, we will see a better level of adherence as physicians are back in control. All the feedback we've had to-date from nephrologists in the marketplace have been very good. They are looking forward to having this drug available. So whether it's a switch or replacement or usage during a treatment period will be dependent upon the physician or the dialysis unit in terms of their guidelines.

所以，我們是根據目前掌握的臨床數據將Parsabiv推向市場，對嗎？因此，從定義上講，繼發性副甲狀腺功能亢進症是一種非常難以治療的疾病，而且治療依從性是一個真正的問題。我認為目前大約有 15 萬名患者正在服用這種藥物，滲透率只有 26% 左右。我們掌握的直接比較數據顯示，Parsabiv 具有很高的療效。我們毫不懷疑，隨著醫師重新掌控局面，患者的依從性將會提高。到目前為止，我們從市場上的腎臟科醫生那裡收到的所有回饋都非常好。他們期待著這種藥物早日上市。因此，是更換、替換還是在治療期間使用，將取決於醫生或透析中心的指導方針。

And our next question is from the line of Umer Raffat from Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Umer Raffat。

I actually had a strategy question today, if I may. And I'm curious, has there been any consideration or deliberation internally on possibly extending the Novartis partnership to include the CV franchise also? And I'm just thinking out loud about Novartis' increased presence in cardiology with ENTRESTO as well as their new CANTOS data. I wasn't sure if this is something that has been deliberated previously and/or how you think about pushes and pulls on a possible setup like this. And it doesn't have to be necessarily a 50-50 but just perhaps thinking about margins and taking advantage of their presence now.

今天我其實有個策略方面的問題想請教一下。我很好奇，公司內部是否考慮過或討論過將與諾華的合作關係擴展到心血管產品線？我只是在自言自語地談論諾華公司憑藉 ENTRESTO 以及他們新的 CANTOS 數據在心臟病學領域日益增強的影響力。我不確定之前是否討論過這個問題，以及您是如何看待在這種可能的安排下各方之間的博弈和拉動的。不一定要是五五開，但或許應該考慮一下利潤空間，並利用他們現在的優勢。

With respect to our partnership with Novartis, we're very happy with how we're collaborating with each other in neuroscience. As you know, we were really attracted to their BACE program because we liked the clinical experiment that's being run there. We believe strongly in BACE, and we believe that the appropriate way to test it is by getting to patients early. And together, that's what we're doing. And they liked our CGRP program and our commitment to migraines. I think we have a good partnership there. We have pioneered a lot of new ground in the cardiovascular space. And we're excited about our intellectual property there, excited about our -- what we see in the pipeline. And so we're content to continue to own all of that franchise certainly in atherosclerosis. And as you know, we have partnerships already in heart failure. So we're generally optimistic and upbeat about what we see happening in cardiovascular. And as David said, we fully invested in the standing up of that franchise.

關於我們與諾華的合作，我們對雙方在神經科學領域的合作方式感到非常滿意。如您所知，我們非常看好他們的 BACE 項目，因為我們喜歡那裡正在進行的臨床試驗。我們堅信 BACE 的療效，並且我們認為檢驗其療效的正確方法是儘早接觸患者。這就是我們共同努力的方向。他們很欣賞我們的 CGRP 計畫以及我們對偏頭痛的治療承諾。我認為我們在那裡建立了良好的合作關係。我們在心血管領域開闢了許多新天地。我們對我們在那裡的知識產權感到興奮，對我們——我們正在研發的項目感到興奮。因此，我們很樂意繼續擁有動脈粥狀硬化領域的所有特許經營權。如您所知，我們在心臟衰竭領域已經有一些合作夥伴。因此，我們對心血管領域的發展前景總體上持樂觀和積極的態度。正如大衛所說，我們為這家特許經營店的建立投入了全部資金。

And our next question is from the line of Michael Yee from Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

I know that you're prepared to give, I'm sure, 2018 guidance in due time, but many years ago you gave longer-term guidance. As you think ahead over the next few years, which I think The Street remains uncertain about, what are the push and pulls that you think need to happen to be able to have visibility to provide that? Or should we stay tuned? How do we think about that? Because that seems to be something, I think, that's weighing on people.

我知道您已做好準備，我相信您會在適當的時候給出 2018 年的指導意見，但多年前您曾給出過更長期的指導意見。展望未來幾年，我認為華爾街對此仍不確定，您認為需要哪些推動和拉動因素才能實現可視性？或者我們應該繼續關注？我們該如何看待這個問題？因為我覺得，這似乎是困擾人們的事。

Yes. Michael, as David said in his remarks, we would expect -- we'd normally give guidance in January for 2018, so we'd expect to do that. As David also said in his remarks, we've made great progress on achieving the objectives that we established for 2018. In some areas, obviously, we're moving more quickly to achieve those objectives than we had expected. So we're looking at the options, what makes sense when we get to providing the next batch of guidance and talking to our shareholders about that.

是的。邁克爾，正如大衛在演講中所說，我們預計——我們通常會在 2018 年 1 月給出業績指引，所以我們預計會這樣做。正如大衛在演講中所說，我們在實現 2018 年制定的目標方面取得了巨大進展。顯然，在某些領域，我們實現這些目標的速度比我們預期的要快得多。所以我們正在研究各種方案，考慮在發布下一批業績指引並與股東討論時，哪些方案才是合理的。

And our next question is from the line of Geoffrey Meacham from Barclays.

下一個問題來自巴克萊銀行的傑弗裡·米查姆。

Real quick one. Sean, on the migraine program, maybe just can you go into a little bit more on 301, what you'd be looking for in a Phase II above and beyond what we see with erenumab? I'm just trying to think about kind of cost benefit and risk benefit.

簡單問一個。Sean，關於偏頭痛項目，你能再詳細談談 301 嗎？在 II 期臨床試驗中，除了 erenumab 的療效之外，你還希望看到什麼？我只是想考慮一下成本效益和風險效益。

Yes, thanks for the question. I think, initially, we have a form of human validation for this pathway and that if the ligand for this receptor is infused into migraineurs, they experience migraine. And this is seen with CGRP as well. And we also have a pharmacodynamic assay that we look at in Phase I, which is very similar to what we did with erenumab, where we know that we're covering the target and peripheral tissues. So the next step for this is to achieve clinical proof-of-concept for the pathway and in terms of the ability to prevent migraine and to understand the dose that's required for that. And then I believe that we need to begin to understand, since these are such different neural circuits in the brain, whether there is a situation in which we can see additive or synergistic activity between PAC1 inhibition and CGRP inhibition, whether there are certain patients who respond to one but not the other or whether we can get, again, a kind of a synergistic effect in patients who do already respond to CGRP inhibition. So I think that's all work that remains, and we, of course, have the option to pursue that either through fixed dose-type combinations, but we also have a bispecific program where we're actually able to inhibit both these targets in a single molecule. And that's all work that's going to be done, as we've mentioned, collaboratively here at Amgen but in collaboration with Novartis.

是的，謝謝你的提問。我認為，首先，我們對這條通路有了某種形式的人體驗證，即如果將該受體的配體注射到偏頭痛患者體內，他們就會經歷偏頭痛。CGRP也有同樣的問題。此外，我們還有一項藥效學檢測，我們在 I 期臨床試驗中進行研究，這與我們之前對 erenumab 所做的非常相似，我們知道我們能夠涵蓋目標組織和周邊組織。因此，下一步是實現該途徑的臨床概念驗證，以及在預防偏頭痛方面的能力，並了解所需的劑量。然後我認為我們需要開始了解，由於這些是大腦中如此不同的神經迴路，是否存在這樣一種情況：我們可以觀察到 PAC1 抑制和 CGRP 抑制之間的疊加或協同作用，是否存在某些患者對其中一種有反應而對另一種沒有反應，或者我們是否可以在已經對 CGRP 抑制有反應的患者身上再次獲得某種協同效應。所以我認為剩下的工作就這些了，當然，我們可以選擇透過固定劑量組合的方式來推進這項工作，但我們也有一個雙特異性方案，我們實際上能夠在一個分子中抑制這兩個靶點。正如我們之前提到的，所有這些工作都將在安進公司內部，並與諾華公司合作完成。

And our next question is from the line of Cory Kasimov from JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

Thanks for taking my question which is on erenumab as well or Aimovig. I wanted to ask about the progress of your prelaunch activities, how they're going and the early reception you're seeing in the part of physicians and especially payers in terms of the level of enthusiasm for the class in general and this product in particular. And maybe how are the responsibilities towards these activities being divided by you and Novartis?

感謝您回答我的問題，我的問題也與依瑞奈單抗（erenumab）或艾莫維格（Aimovig）有關。我想詢問一下你們的上市前活動進展情況，以及你們從醫生和支付方那裡了解到的早期反響，特別是他們對這門課程和這款產品的熱情程度。那麼，您和諾華公司是如何劃分這些活動的責任的呢？

This is Tony. Thanks, Cory. I just came back from the international headache conference, which was in Vancouver, where I was meeting with a group of key opinion leaders and individuals who run headache clinics. Together with me was my counterpart from Novartis, Paul Hudson. So he and I will work in this together. So as we think strategically -- the 2 organizations are doing a lot of strategic thinking together. We both jointly agree we probably saw more enthusiasm from this set of neuro physicians than we've ever seen in many other physicians in other congresses. People talking about this is the first time they have been able to potentially prescribe a migraine drug for migraine patients in 2 decades. So I came away feeling much more positive about the scientific understanding, the clinical needs and the large population that is waiting for this. The work we've done at the moment with migraine bloggers and patients who are suffering from migraine has also been very beneficial. We understand much better now the patient journey, the importance of the work we have to do with patients and their willingness to work with us to spread this good message once we have our drug approved. Obviously, we continue to work with payers in strategic discussions, but we haven't made any final decisions around pricing as we go forward.

這是托尼。謝謝你，科里。我剛從溫哥華舉行的國際頭痛大會回來，在那裡我與一群關鍵意見領袖和經營頭痛診所的人士會面。與我同行的還有諾華公司的保羅‧哈德森。所以，我和他將共同努力。因此，從策略角度來看──這兩個組織正在共同進行大量的策略思考。我們一致認為，這群神經科醫師所展現的熱情，可能比我們在其他大會上看到的許多醫生都要高。人們談論此事時表示，這是二十年來他們第一次有可能為偏頭痛患者開立偏頭痛藥物。因此，我帶著更積極的態度離開了，對科學認知、臨床需求以及等待這項技術的大量人群有了更清晰的認識。我們目前與偏頭痛部落客和偏頭痛患者所進行的工作也非常有益。我們現在對患者的就醫歷程有了更深入的了解，也更明白我們與患者共同努力的重要性，以及一旦我們的藥物獲得批准，他們願意與我們合作傳播這一好消息。顯然，我們仍在與支付方進行策略討論，但對於未來的定價，我們還沒有做出任何最終決定。

And our next question is from the line of Alethia Young from Credit Suisse.

下一個問題來自瑞士信貸的 Alethia Young。

Another one for you, Tony, on the migraine. I guess, can you maybe talk about parallel learnings from PCSK9, they are kind of similarly big and like how to think about the migraine market in light of what the payers could do and strategies you have there?

東尼，再給你講講偏頭痛的事。我想，您能否談談從 PCSK9 中獲得的類似經驗？它們規模相當大，例如如何根據支付方可能採取的措施以及您在這方面的策略來思考偏頭痛市場？

Sure, Alethia. So I think, first of all, the magnitude of the market is different, right? In the U.S., we estimate about 3.5 million patients right now are being treated for prophylactic treatment of migraine. A lot of those patients fail, a lot of those patients go off treatment because of side effects, a lot of those patients find the treatment is not effective. I think we believe that we will clearly be positioned for patients who failed existing therapy. And last but not least, I think patients are much more aware of the disease. This is a symptomatic disease. When you have a migraine, you're very much aware of it. So I think patient mobilization in terms of their voice around the need to have access to drug is going to be important. The value these drugs bring to the marketplace, too, when you think about how debilitating migraine really is in terms of stopping people from going to work, preventing people from being mothers or caregivers, there's huge value to society to allow these people to get back their independence and to become normal citizens again.

當然可以，阿萊西亞。所以我覺得，首先，市場規模是不同的，對吧？據估計，目前美國約有 350 萬名患者正在接受偏頭痛的預防性治療。很多患者治療失敗，很多患者因為副作用而停止治療，很多患者發現治療無效。我認為我們有信心，我們將為那些現有療法無效的患者提供明確的治療方案。最後但同樣重要的是，我認為患者對這種疾病的認識大大提高了。這是一種症狀性疾病。當偏頭痛發作時，你會非常清楚地感受到它。所以我認為，動員患者表達他們獲得藥物的需求是很重要的。考慮到偏頭痛對人們的危害有多大，它會阻止人們工作，阻止人們成為母親或照顧者，這些藥物對市場的價值就顯而易見了。讓這些人重獲獨立，重新成為正常公民，對社會有巨大的價值。

Our next question is from the line of Ronny Gal from Bernstein.

我們的下一個問題來自伯恩斯坦的 Ronny Gal 的系列。

Two questions. First, CMS seems to be contemplating a single J-code for biosimilars innovative products. How do you guys feel that would help the biosimilar market? And second, one of your peers appears to be pushing up the pricing band for oncolytics. What is your take on that? Is the current investment into oncolytics justifies gradually raising the price band on those products?

兩個問題。首先，CMS似乎正在考慮為生物相似藥創新產品設立一個單一的J程式碼。你們覺得這對生物相似藥市場有什麼幫助？其次，你的一位同行似乎正在推高腫瘤治療藥物的價格區間。你對此有何看法？目前對腫瘤治療藥物的投資是否足以支撐逐步提高這些產品的價格區間？

Yes. Okay, there's 2 questions there, Ronny. I'm not sure we're going to want to talk about pricing. But with respect to J-codes, this is an important issue that we've been active in trying to help legislators understand. So Tony, go ahead.

是的。好的，羅尼，這裡有兩個問題。我不確定我們是否要討論價格問題。但就 J 代碼而言，這是我們一直積極努力幫助立法者理解的重要議題。東尼，你開始吧。

So we clearly believe that having a single J-code is not what you want, right? If you believe that a biosimilar has to be a decision made by a physician, you want clarity around each single product, has to be able to reflect in the marketplace. So we're working hard to ensure that we have actual J-code by product as we go forward. On the pricing one, I'm not quite sure what the competition is doing, and that's their decision.

所以，我們顯然認為您並不想要一個單一的 J 代碼，對嗎？如果你認為生物相似藥必須由醫生決定，那麼你希望每個產品都有明確的訊息，並且能夠反映在市場上。因此，我們正在努力確保我們未來的產品能夠真正實現 J 程式碼。關於定價方面，我不太清楚競爭對手的做法，那是他們的決定。

Yes. We launched our oncolytic antiviral product -- or antiviral therapy with a very, we think, compelling value proposition, as you perhaps recall, Ronny. So we were trying to help institutions and patients understand that we are willing to cap their exposure from a price perspective. And I think that's well received in the marketplace.

是的。羅尼，你可能還記得，我們​​推出了溶瘤抗病毒產品——或者說抗病毒療法，我們認為它具有非常有吸引力的價值主張。因此，我們試圖幫助機構和患者理解，我們願意從價格角度限制他們的風險敞口。我認為這在市場上會受到好評。

And our next question is from the line of Kennen MacKay from RBC Capital Markets.

下一個問題來自加拿大皇家銀行資本市場的 Kennen MacKay。

Arvind, thank you for the recognition of our initiation. And Bob, it's a huge relief to hear that your Puerto Rico staff is safe and accounted for here. I actually had one quick question on Hurricane Maria. David, you'd mentioned the $67 million in one-time quarterly damage associated with the hurricane was partially due to inventory and was just curious if this was inventory lost in Puerto Rico? And I had also been looking at the product slides Tony had in the slide deck and it looked like there were inventory drawdowns across the board with the exception of Sensipar. Is that a function of hurricane disruption? Or is that just sort of quarterly reflection there?

Arvind，謝謝你對我們入會儀式的認可。鮑勃，聽到你的波多黎各員工平安無事，我真是鬆了一口氣。我其實有個關於瑪莉亞颶風的小問題。大衛，你之前提到颶風造成的 6700 萬美元季度一次性損失部分是由於庫存損失造成的，我只是好奇這是否是指在波多黎各損失的庫存？而且我還看了托尼在幻燈片裡展示的產品幻燈片，看起來除了 Sensipar 之外，所有產品的庫存都出現了下降。這是颶風造成的破壞嗎？或者那隻是某種季度回顧？

Sure. So it is true, what happened as a result of the hurricane is we have some product that was in process that it turned out was contaminated, and so we have to scrap that product. So that was the inventory impact, which was a portion of the $67 million of cost for the company. In terms of other disruption within the context of Puerto Rico, we have ample inventory for such interruptions. And so it hasn't impacted, obviously, our ability to supply. And Tony will probably comment. But I think the -- as to the second part of the question, that's your normal dynamics that we see...

當然。所以確實，颶風造成的後果是，我們有一些正在生產的產品被污染了，所以我們不得不報廢這些產品。這就是庫存的影響，占公司 6700 萬美元成本的一部分。就波多黎各可能出現的其他中斷情況而言，我們有充足的庫存來應對此類中斷。因此，顯然這並沒有影響我們的供應能力。托尼可能會發表評論。但我認為——至於問題的第二部分，那是我們通常看到的動態…

Yes. I don't think any of the inventory movement had anything to do with the hurricane. Most of the discrepancies were as a result of contracts ending early and buying-in that took place in the second quarter, which would normally happen in the third quarter. There was sufficient inventory both in our supply chain here as well as in the wholesaler supply chain during this period.

是的。我認為庫存變動與颶風沒有任何關係。大部分差異是由於合約提前結束以及在第二季度進行的買入造成的，而這些買入通常應該在第三季進行。在此期間，我們自身的供應鏈以及批發商的供應鏈中都有充足的庫存。

And our next question is from the line of Andrew Peters from Deutsche Bank.

下一個問題來自德意志銀行的安德魯彼得斯。

I guess, just another biosimilar one. So regarding the overall portfolio, while regulatory time lines appear relatively straightforward, wondering if you can provide a little bit more context regarding potential launch timing. I know it's kind of on a case-by-case basis relative to, I guess, legal negotiations, et cetera. Just wanted to understand if you have any sense of where we are in the process for the various products and how you think about timing overall to come into market.

我猜，這不過是另一種生物相似藥而已。因此，就整體產品組合而言，雖然監管時間表看起來相對簡單明了，但我想知道您能否提供一些關於潛在發佈時間的更多資訊。我知道這在某種程度上要視具體情況而定，例如涉及法律談判等等。我只是想了解一下，您是否知道我們各個產品的研發進度如何，以及您對產品整體上市時間的看法。

Well, Andrew, I guess, the premise that it's relatively straightforward to develop these is one that people are struggling with in the industry. But as I said earlier, I think we expected that some of our competitors would struggle to achieve biosimilarity, and we would observe that, that's been playing out. So far we've been fortunate to be able to advance molecules that have passed the test with not just regulators here in the U.S. but globally. We're committed to continue to try to do that. Obviously, the first step through -- along the journey is getting our products approved. We have now, as you know, 2 of them, AMGEVITA and MVASI, which is our biosimilar to Avastin. And we now have clarity around our launch plans for AMGEVITA. And we're excited about that. We have ongoing litigation with respect to MVASI, so I think it's probably inappropriate to talk about that now. But generally, I think that since -- in the U.S. anyway, this pathway is still so new, there probably are still some regulatory paths to be made more clear. And I think certainly on the intellectual property front, there's still more work to be done in the field before we can all start to predict launch timetables accurately. So I'd like to resist trying to do that on this call. But I would remind you that we continue to be transparent about where our products are, when they enter pivotal Phase III trials and when we file them with regulators, and we'll continue to do that.

安德魯，我想，開發這些東西相對簡單易行的前提，正是業內人士正在努力克服的難題。但正如我之前所說，我認為我們預料到一些競爭對手在實現生物相似性方面會遇到困難，而我們也觀察到這種情況正在發生。到目前為止，我們很幸運能夠推進一些分子的研發，這些分子不僅通過了美國監管機構的審查，也通過了全球監管機構的審查。我們將繼續努力實現這一目標。顯然，實現這一目標的第一步是獲得產品批准。如您所知，我們現在有 2 種這樣的藥物，分別是 AMGEVITA 和 MVASI，後者是我​​們的 Avastin 生物相似藥。現在我們對AMGEVITA的發布計劃有了更清楚的了解。我們對此感到興奮。我們目前正與 MVASI 進行訴訟，所以我覺得現在談論這件事可能不太合適。但總的來說，我認為，由於——至少在美國——這條途徑仍然很新，可能還有一些監管途徑需要進一步明確。而且我認為，在智慧財產權方面，我們還有很多工作要做，才能開始準確預測產品發佈時間表。所以，我希望在這通電話中盡量避免這樣做。但我要提醒各位，我們將繼續保持透明，公開我們的產品現狀、何時進入關鍵的 III 期試驗以及何時向監管機構提交申請，我們也會繼續這樣做。

And our next question is from the line of Salim Syed from Mizuho Securities.

下一個問題來自瑞穗證券的 Salim Syed。

I had a question on Repatha. So we're getting the ODYSSEY outcomes data early 2018. And if we get a scenario here where the data is optically -- looks optically better, right, because of the longer duration trial, but it still falls along the CTC line, how do you guys view that? Is that a good because it grows the market, you think, or a bad because that's competitor data? Just curious what your thoughts are there?

我有一個關於Repatha的問題。因此，我們將在 2018 年初獲得 ODYSSEY 的結果數據。如果發生這樣一種情況：數據從光學角度來看更好，對吧，因為試驗持續時間更長，但它仍然落在 CTC 線上，你們怎麼看？你認為這是好事，因為它能擴大市場；還是壞事，因為這是競爭對手的數據？只是好奇你對此有何看法？

It sounds like you're trying to draw us into a discussion of hypotheticals there, Salim. I think, Sean, if you feel you want to draw on that, fire away. But I hope to take a moment just to reiterate what we've learned about our products in the outcomes trial.

薩利姆，聽起來你好像想引導我們討論一些假設性的問題。肖恩，我覺得，如果你想利用這一點，那就儘管放手去做吧。但我希望花一點時間重申我們在結果試驗中了解到的產品資訊。

Yes. Well, I mean, my view would be that we have already seen with bococizumab, although they had their immunogenicity issues, which caused the molecule not to be able to be commercialized. We've already seen 2 PCSK9 inhibitors clearly fall along the CTC line. And so is it good for the science and for the field to have a third outcomes result? Sure. I mean, the reason there's so much confidence in statins, for example, is we have a couple dozen outcomes trials that all more or less show the same thing. And I think -- so from a scientific perspective, I think it will reinforce a number of the issues. And so in that way, I look forward to having -- seeing the additional data. Tony, obviously.

是的。嗯，我的意思是，我的看法是，我們已經從 bococizumab 身上看到了這一點，儘管它存在免疫原性問題，導致該分子無法商業化。我們已經看到 2 種 PCSK9 抑制劑明顯屬於 CTC 線。那麼，對於科學和該領域來說，出現第三種結果是否有益呢？當然。我的意思是，例如，人們對他汀類藥物如此有信心的原因是，我們有幾十項結果試驗，這些試驗或多或少都顯示了相同的結果。而且我認為——從科學的角度來看，我認為這將強化一些問題。因此，我期待看到更多的數據。當然是托尼。

I think, if you would, at the ESC, recently when we presented some of the subcuts of the Repatha outcomes data and we looked at the cohort where you had patients who entered at LDLs below 70 and how as you drove LDL down to levels way below 70, you actually got a higher reduction in myocardial infarction and reduction in stroke. And our data alone showing up to about a 33% reduction in MI. I can't understand why you wouldn't want to do anything other than drive LDL down as low as you can. So our drug does that. Other drugs don't.

我想，如果您願意的話，在最近的歐洲心臟病學會 (ESC) 會議上，當我們展示 Repatha 結果數據的一些子數據時，我們研究了低密度脂蛋白膽固醇 (LDL) 低於 70 的患者隊列，以及當 LDL 降至遠低於 70 的水平時，心肌梗塞和中風的發生率實際上顯著降低。僅我們的數據顯示，MI 減少了約 33%。我不明白為什麼你除了盡可能降低低密度脂蛋白膽固醇（LDL）水平之外，什麼都不想做。我們的藥物就是起到這種作用的。其他藥物則不會。

And our next question is from the line of Ian?Somaiya from BMO Capital Markets.

下一個問題來自 BMO 資本市場的 Ian Somaiya。

Just wanted to follow up on one of the earlier questions on Puerto Rico. Can you just give us a sense for your ability to continue to sort of manufacture in Puerto Rico? Is that based on resumption of some sense of normalcy? And when would that need to occur? Or can you continue to manufacture based on sort of the contingency plans that you have in place?

我想就之前關於波多黎各的一個問題做個後續說明。您能否簡要說明一下您在波多黎各繼續進行生產的能力？這是基於某種程度的正常生活恢復嗎？那又該何時發生呢？或者，你們能否根據現有的緊急應變計畫繼續生產？

We have very robust contingency plans in place, Ian, and we're up and running. Virtually, all of our activities are up and running. We have astonishingly almost all of our 2,000 staff are back at work. Despite enormous disruptions in their personal lives, they're back at work and making products for patients around the world. So we are -- I must say, we're humbled and incredibly proud of what we've seen from our staff down there over the last 5 weeks. So we're up and running. We are dependent on our own sources of power right now, and we're looking forward to the island getting the electrical grid restored. We're looking forward to the communications grid getting restored, looking forward to a reliable water supply. We think we're in pretty good shape there at the moment, though. And the roads -- and gradually, things are getting back to normal for the families who work at companies like Amgen. But the good news is we're up and running.

伊恩，我們已經制定了非常完善的緊急應變計畫，而且一切運作都正常。實際上，我們所有的活動都已恢復並正常進行。令人驚訝的是，我們2,000名員工幾乎全部都已復工。儘管他們的個人生活受到了巨大的干擾，但他們已經重返工作崗位，為世界各地的患者生產產品。所以，我必須說，我們對過去 5 週我們在那裡的員工所展現出的能力感到無比榮幸和自豪。我們已經啟動並開始運行了。我們目前依靠自己的電力來源，期待島上的電網能盡快恢復。我們期待通訊網路恢復正常，期待可靠的供水。不過，我們認為目前我們的情況還不錯。道路也逐漸恢復正常了——對於在安進等公司工作的家庭來說，生活也慢慢恢復正常了。但好消息是我們已經恢復運作了。

Yes. No, that's right. As of this week, all of the plants where we have demand requirements are fully ramped up and are producing. So -- and that's very recently that's happened. But we don't see any -- as I said earlier, we don't see any risk of disruption of supply. And I think, importantly, we're back up and running and feel very good about that. And the one thing that's not as convenient is the fact we're running on our own power, and we look forward to that being restored. But that doesn't create any risk of our ability to produce. So yes, it's come out very well, I think.

是的。沒錯。截至本週，所有我們有需求的工廠都已全面開工生產。所以——而且這件事是最近才發生的。但正如我之前所說，我們沒有看到任何供應中斷的風險。而且我認為，更重要的是，我們已經恢復正常運轉，對此我感到非常滿意。唯一不太方便的是，我們目前依靠自身電力運營，我們期待電力供應能夠盡快恢復。但這並不會對我們的生產能力造成任何風險。是的，我覺得效果非常好。

Our next question is from the line of Jim Birchenough from Wells Fargo Securities.

我們的下一個問題來自富國證券的吉姆·伯奇諾夫。

I guess, just a strategic question and given your focus on bispecific T-cell engagers and BLINCYTO and given the acquisition of Kite by Gilead and your relationship with Kite as well, can you maybe speak to your interest in the cell therapy area to complement what you're doing with bispecifics?

我想問一個策略性的問題，鑑於您專注於雙特異性 T 細胞銜接器和 BLINCYTO，以及吉利德收購 Kite 並與您保持聯繫，您能否談談您對細胞療法領域的興趣，以補充您在雙特異性療法方面的工作？

Yes. Thanks for the question. I think we do have an interest in cell-based therapies, and we're very happy that we have the collaboration with Kite, now Gilead, around the 6 targets that we set up in that original deal. And we're learning a lot there and we're progressing those programs. I think our perspective remains, as we've looked at the technologies that the bispecific T-cell engaging approach both in hematologic malignancies and increasingly in solid tumors, particularly in combination with checkpoint inhibitors, is appearing to be a very powerful technology. And these are off-the-shelf products that can be administered virtually immediately to patients and may offer a benefit-risk profile that would allow them to be used in earlier lines of therapy than the current benefit-risk profile for CAR T therapies, for example, tends to limit them to later stages of situations, where patients are rather deep into their relapsed and refractory phases of their disease. I also think that we have a significant opportunity here now that we have the sense from accumulating data in our own hands and seeing what's going on out in the rest of the industry of the opportunity for BiTEs to have activity in solid tumors. And so I think we have a very large number of programs that we are pushing through the pipeline right now against both hematologic and solid tumor products. I think cell-based therapies do have a role, and that role will probably increase over time as some of the technology matures. And it may be possible to use them in earlier lines of therapy, as I mentioned. And we're tracking that closely. But right now, for the immediate kind of foreseeable 3- to 5-year period, we remain very enthusiastic about the bispecific T-cell engaging platform, particularly now with the half-life extended protein engineering.

是的。謝謝你的提問。我認為我們對細胞療法很感興趣，我們很高興能與 Kite（現為 Gilead）就我們在最初協議中確定的 6 個靶點展開合作。我們在那裡學到了很多東西，並且正在推進這些項目。我認為我們的觀點仍然如此，正如我們所看到的，雙特異性 T 細胞接合療法在血液惡性腫瘤和越來越多的實體瘤中，尤其是在與檢查點抑制劑聯合使用時，似乎是一種非常強大的技術。這些都是現成的產品，可以立即給患者使用，並且其獲益風險比可能使其能夠用於更早的治療階段。例如，目前的 CAR-T 療法的獲益風險比往往將其限制在疾病的後期階段，此時患者已處於疾病復發和難治期的相當深入的階段。我也認為，現在我們面臨著一個重要的機遇，因為我們透過累積自己的數據，並了解了產業其他領域的情況，意識到 BiTE 在實體瘤治療中具有活性。因此，我認為我們目前正在大力推動大量針對血液腫瘤和實體腫瘤產品的研發項目。我認為細胞療法確實有其作用，而且隨著一些技術的成熟，這種作用可能會隨著時間的推移而增加。正如我之前提到的，它們或許可以用於更早的治療方案。我們正在密切關注此事。但就目前而言，在可預見的 3 到 5 年內，我們仍然對雙特異性 T 細胞接合平台充滿熱情，尤其是在半衰期延長的蛋白質工程技術出現之後。

And our next question is from the line of Carter Gould from UBS Equities.

下一個問題來自瑞銀證券的卡特古爾德。

One for Sean real quick. How should we think about AMG 986 development in the context of omecamtiv. Is this -- should it proceed more as a backup or complementary? And if there's any sort of just natural patient segmentation that might follow off from the mechanism for these 2 assets, that would be helpful.

給肖恩快速回答一個問題。我們應該如何看待 omecamtiv 背景下的 AMG 986 開發？這——應該更多地作為備用方案還是補充方案？如果這兩種資產的機制能夠自然而然地產生某種患者細分，那將會很有幫助。

Yes. It's a great question. I mean, this is really a completely different mechanism of action than myosin activation. And while they're both targeting patients with heart failure, that's kind of where the obvious similarities end. I would say that what's been particularly exciting with apelin is the fact that we are seeing not only enhanced contractility, so systolic effect, but we're actually seeing enhancement of cardiac relaxation or diastolic effect. And that is unique in our knowledge to this particular mechanism. So it allows us to consider pursuing add-on therapy presumably to standard of care in the reduced ejection fraction setting as we are doing with omecamtiv mecarbil in our experiment right now in Phase III, which by the way, is enrolling extremely well. And -- but also to explore the situation where there's absolutely no registered therapy available for the heart failure with preserved ejection fraction population, which is a very large population and is currently very underserved. So it's still reasonably early days in the clinic, Phase I, but this is one of the more exciting programs we have in cardiovascular arena.

是的。這是一個很好的問題。我的意思是，這與肌球蛋白活化的作用機製完全不同。雖然它們都以心臟衰竭患者為目標，但除此之外，兩者之間幾乎沒有其他明顯的相似之處。我認為apelin 最令人興奮的地方在於，我們不僅看到了增強的收縮力（即收縮期效應），而且實際上還看到了增強的心臟舒張作用（即舒張期效應）。據我們所知，這是這種特定機制所獨有的。因此，我們可以考慮在射血分數降低的情況下，對標準治療進行附加治療，就像我們目前正在進行的 III 期試驗中用 omecamtiv mecarbil 進行治療一樣，順便說一句，該試驗的招募工作進展得非常順利。此外，也要探討目前對於射血分數保留的心臟衰竭患者群體（這是一個非常龐大的群體，目前卻沒有得到充分的醫療服務）而言，完全沒有註冊療法的情況。所以目前還處於臨床早期階段，屬於第一階段，但這是我們在心血管領域最令人興奮的項目之一。

Okay. Well, thank you, Sean. I think we probably should break now, but let me just say a couple of quick thoughts in conclusion. First, I hope you can see that we're executing on our strategy and that we've put the company in a strong position for dealing with the realities of the environment that exist in our industry today. I'm pleased with our efforts to drive growth

好的。謝謝你，肖恩。我想我們現在應該休息一下了，但最後我想簡單說幾點。首先，我希望你們能夠看到我們正在執行我們的策略，並且我們已經使公司處於一個強大的地位，能夠應對當今行業環境中存在的現實情況。我對我們推動成長的努力感到滿意。

As well as with the life cycle management of our mature brands. And I want to just end by thanking our staff globally and particularly once more our colleagues in Puerto Rico for driving results and delivering for patients.

以及我們成熟品牌的生命週期管理。最後，我要感謝我們全球的員工，特別要再次感謝我們在波多黎各的同事們，感謝他們為病人帶來成果和福祉。

Great. Thanks, Bob, and I would like to thank all of you for your participation. Of course, if you have any follow-on questions, comments that you would like to discuss, feel free to reach out to me and my team. We'll be around for several hours. Thanks again.

偉大的。謝謝你，鮑勃，我也要感謝各位的參與。當然，如果您有任何後續問題或想討論的意見，請隨時與我和我的團隊聯繫。我們將在這裡待幾個小時。再次感謝。

Ladies and gentlemen, this concludes Amgen's Third Quarter 2017 Financial Results Conference Call. You may now disconnect.

女士們、先生們，安進公司2017年第三季財務業績電話會議到此結束。您現在可以斷開連線了。