美國安進 (AMGN) 2016 Q3 法說會逐字稿

My name is Jake Wong and I will be your conference facilitator today for Amgen's third-quarter 2016 financial results conference call.

我叫 Jake Wong，今天我將擔任安進公司 2016 年第三季財務業績電話會議的主持人。

(Operator Instructions)

（操作說明）

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

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, thank you. Good afternoon, everybody. I'd like to welcome you to our third-quarter financial results conference call. I would like to begin today by wishing Mark Schoenebaum of ISI Evercore, who as many of you might know, is on medical leave, I'd like to wish him a speedy recovery, and also welcome John Scotti who is covering the large cap biotech companies in Mark's absence. Also in acknowledging those were new in the coverage, I would like to welcome Carter Gould of UBS, who will be initiating coverage of the sector and our Company.

好的，謝謝。大家下午好。歡迎各位參加我們第三季財務業績電話會議。今天首先，我想向 ISI Evercore 的 Mark Schoenebaum 致以問候，正如你們中的許多人可能知道的那樣，他正在休病假，我祝他早日康復。同時，我也歡迎 John Scotti 加入，他將在 Mark 不在期間負責報道大型生技公司。此外，考慮到這些是報導中的新內容，我謹歡迎瑞銀集團的卡特·古爾德先生，他將負責對該行業和我們公司進行報告。

Our performance during the quarter is best characterized by considerable operating leverage, as earnings growth well exceed revenue growth. We successfully executed on our lifecycle management strategies for older products while continuing to make efforts to make our new product launches a success. To discuss our performance in greater detail, I'm joined today by Bob Bradway, our Chairman and CEO, who will make some introductory comments. Our CFO, David Meline, will then review our quarterly results and update you on our guidance for 2016. Following David, our Head of Global Commercial Operations, Tony Hooper, will discuss our product performance during the quarter, followed by our Head of R&D, Sean Harper, who will provide a pipeline update. We should have plenty of time for Q&A after Sean's comments.

本季業績最顯著的特點是營運槓桿效應顯著，獲利成長遠超營收成長。我們成功執行了舊產品的生命週期管理策略，同時繼續努力確保新產品的發布成功。為了更詳細地討論我們的業績，今天我邀請到了我們的董事長兼首席執行官鮑勃·布拉德韋，他將作一些開場白。我們的財務長大衛梅林隨後將審查我們的季度業績，並向您報告我們對 2016 年的業績展望。繼 David 之後，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，隨後是我們的研發主管 Sean Harper，他將提供產品線更新資訊。在肖恩發言結束後，我們應該有足夠的時間進行問答環節。

As in the past, we will use slides for presentation today which have been posted on our website and a link was sent to you separately by e-mail. 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 schedule accompanying today's press release, our Form 8-K and also on the Investor Relations section of our website.

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

Just a reminder that some of the statements 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. With that, I would like to turn the call over to Bob.

提醒各位，我們今天演講中的一些陳述屬於前瞻性陳述，我們在 2015 年提交的 10-K 表格及後續文件中列出了可能導致我們實際結果與預期結果有重大差異的因素。接下來，我想把電話交給鮑伯。

Okay, thank you, Arvind. Our business has performed well through the first nine months of the year and we continue to make progress in delivering our strategy for long-term growth. At the heart of our strategy is innovation. As you can see, once again in the third quarter we enjoyed strong unit volume growth for a number of our newer innovative products including Prolia, XGEVA, Sensipar, Vectibix and Nplate.

好的，謝謝你，Arvind。今年前九個月，我們的業務表現良好，我們將繼續推動長期成長策略的實施。創新是我們策略的核心。正如您所看到的，第三季度我們許多較新的創新產品（包括 Prolia、XGEVA、Sensipar、Vectibix 和 Nplate）的銷售再次實現了強勁增長。

As international expansion is an important objective for us, it is worth noting as well that our unit volumes grew 12% outside of the US. With respect to that 12%, recognize that the competition for our legacy products began much earlier outside of the US than inside, so what you see in this number is the strong demand for our new innovative medicines emerging internationally. Our transformation program, which we announced over two years ago, is foundational for our long-term objectives and we've achieved momentum in that effort as evidenced in this quarter's results, with operating leverage across all of our business, enabling us to grow earnings well ahead of revenues and deliver a nearly 53% operating margin.

國際擴張是我們的重要目標，值得一提的是，我們在美國以外的銷售量成長了 12%。關於這 12%，要知道，我們傳統產品的競爭在美國以外地區比在美國境內開始得早得多，所以你從這個數字中看到的是國際上對我們新出現的創新藥物的強勁需求。我們兩年前宣布的轉型計劃是我們長期目標的基礎，並且我們已經取得了進展，本季度的業績證明了這一點。我們所有業務的營運槓桿作用使我們能夠實現遠超收入成長的獲利成長，並實現了近 53% 的營業利潤率。

Just as importantly, the transformation is improving our agility, which shows up in our ability to move a program like Erenumab to market ahead of the competition and in our ability to rapidly adapt to changing demands in the marketplace as we have done in the dialysis market with our long-acting Aranesp. I've said for some time that the strength of our legacy franchises is reflected in our durable cash flows. This quarter we generated $2.5 billion of free cash flow. Stable cash flow like this enables us to invest for the long-term both internally and externally while at the same time returning significant cash to our shareholders.

同樣重要的是，這種轉型提高了我們的敏捷性，這體現在我們能夠比競爭對手更快地將 Erenumab 等項目推向市場，以及我們能夠快速適應市場不斷變化的需求，就像我們在透析市場推出長效 Aranesp 一樣。我曾多次說過，我們傳統特許經營業務的實力體現在我們持續穩定的現金流上。本季我們產生了25億美元的自由現金流。穩定的現金流使我們能夠進行長期的內部和外部投資，同時也能為股東帶來可觀的現金回報。

We continue to invest globally in the long-term success of our newly launched products, which we expect will generate meaningful revenues over time. In cardiovascular, the Phase 3 results from our recent Repatha coronary imaging study constitutes one more success in our clinical development program for this molecule.

我們將繼續在全球範圍內投資，以確保新推出的產品能夠取得長期成功，我們預計這些產品隨著時間的推移將產生可觀的收入。在心血管領域，我們最近進行的 Repatha 冠狀動脈影像研究的 3 期結果，標誌著我們針對該分子所進行的臨床開發計畫又取得了一項成功。

This study demonstrates the powerful effects of Repatha on atherosclerotic plaque in the coronary arteries, the major underlying cause of cardiovascular disease and the leading cause of death worldwide. This is especially impressive considering that these results were generated on top of maximized statin therapy. Cardiovascular outcomes data, which are expected in the first quarter next year, will obviously be important for Repatha and should definitively establish the importance of this therapy for those at risk of cardiovascular disease.

這項研究表明，Repatha 對冠狀動脈粥樣硬化斑塊具有強大的作用，而冠狀動脈粥樣硬化斑塊是心血管疾病的主要潛在病因，也是全球主要的死亡原因。考慮到這些結果是在最大限度使用他汀類藥物治療的基礎上取得的，這一點尤其令人印象深刻。預計明年第一季公佈的心血管結果數據對 Repatha 來說顯然非常重要，並且應該能夠最終確定這種療法對有心血管疾病風險的人的重要性。

In oncology, the Neulasta Onpro kit continues to impress adopters in the marketplace and this has proven to be a very successful launch. Multiple myeloma is a rapidly changing field where we've proven KYPROLIS to be the superior proteasome inhibitor for relapsed multiple myeloma patients. We are focused on growing KYPROLIS in this important segment around the world and early launch results in Europe are encouraging, especially in Germany.

在腫瘤學領域，Neulasta Onpro 套件持續給市場上的使用者留下深刻印象，事實證明，這是一個非常成功的上市。多發性骨髓瘤是一個快速變化的領域，我們證明 KYPROLIS 是治療復發性多發性骨髓瘤患者的優良蛋白酶體抑制劑。我們致力於在全球發展 KYPROLIS 在這一重要領域，目前在歐洲的早期上市結果令人鼓舞，尤其是在德國。

With respect to our innovative pipeline, our focus remains on addressing unmet medical needs with innovative medicines that make a big difference for patients. Our next wave of new medicines is set to do just that. In neuroscience we've already reported successful pivotal studies with our migraine medicine, Erenumab, in both chronic and episodic migraine. This is a potentially life-changing medicine for migraine sufferers and we are pleased to be the in the lead position in the CGRP class.

就我們的創新研發管線而言，我們始終專注於以創新藥物滿足未被滿足的醫療需求，為病患帶來重大改變。我們下一批新藥的目標正是如此。在神經科學領域，我們已經報告了我們的偏頭痛藥物 Erenumab 在治療慢性偏頭痛和發作性偏頭痛方面取得的關鍵性研究成功。對於偏頭痛患者來說，這是一種可能改變人生的藥物，我們很高興能在 CGRP 類藥物中處於領先地位。

Round out our franchise in bone health, we recently shared more clinical data on our novel bone building agent, Romosozumab. Experts in the field are excited about the potential of Romosozumab and we look forward to our PDUFA date in July. In biosimilars, Amjevita, which is of course our biosimilar to adalimumab, is our first approval among the many biosimilar programs that we expect will help generate long-term growth in Amgen. As you know, we're in litigation with AbbVie over Amjevita and it is safe to say that there will be more litigation before there's a launch. Given the pace of that litigation, it is unlikely that this that it will be clarified in time for us to launch in 2017. We've also successfully completed Phase 3 studies in two more biosimilars and look forward to their regulatory progress.

為了完善我們在骨骼健康領域的業務，我們最近分享了更多關於我們新型骨骼構建藥物 Romosozumab 的臨床數據。該領域的專家對 Romosozumab 的潛力感到興奮，我們期待著 7 月的 PDUFA 日期。在生物相似藥領域，Amjevita（當然是我們針對阿達木單抗的生物相似藥）是我們眾多生物相似藥計畫中第一個獲得批准的產品，我們期望它能幫助安進實現長期成長。如您所知，我們正在與艾伯維就Amjevita進行訴訟，可以肯定的是，在產品上市之前還會有更多的訴訟。鑑於該訴訟的進展速度，不太可能在 2017 年我們能夠順利推出產品之前得到澄清。我們也成功完成了另外兩種生物相似藥的3期臨床試驗，並期待它們在監管審批方面取得進展。

While talking about R&D I want to say also a few words about the healthcare debate in the United States. I think it's obvious that this debate is not going to dissipate anytime soon and that all of us in the community must work together to find more affordable healthcare solutions. As we seek to do that, we should not lose sight of the fact that it is the economic and societal burden of disease that is the enemy, and innovative biopharmaceutical drugs offer the promise of addressing that burden. We're at the dawn of a very exciting era for innovation. We see that today in cancer, we see in cardiovascular medicine and I think we will see it Alzheimer's and other devastating illness as well.

在談到研發時，我也想談談美國的醫療保健辯論。我認為很明顯，這場爭論不會很快平息，我們社區的所有人都必須共同努力，尋找更經濟實惠的醫療保健解決方案。在我們努力實現這一目標的過程中，我們不應忘記，疾病帶來的經濟和社會負擔才是真正的敵人，而創新的生物製藥藥物可望解決這一負擔。我們正處於一個激動人心的創新時代的黎明。我們今天在癌症領域看到了這一點，在心血管疾病領域也看到了這一點，我認為我們也會在阿茲海默症和其他毀滅性疾病中看到這一點。

But if we're to advance promising new medicines, we have to do that with an eye to both the price and the value of these therapies. We must do it in a way that maintains the role of physicians in making the best decisions for patients. We price our products to offer a strong value proposition for patients, payers and providers. We believe the differentiated efficacy of our products enables us to take a leading role in our industry in structuring value-based partnerships for our medicines.

但是，如果我們想要推進有前景的新藥研發，就必須同時考慮這些療法的價格和價值。我們必須以一種能夠維護醫生在為患者做出最佳決策方面所發揮作用的方式來做到這一點。我們為產品定價，旨在為患者、支付者和醫療服務提供強大的價值主張。我們相信，我們產品的差異化功效使我們能夠在建立基於價值的藥品合作夥伴關係方面，在產業中發揮領導作用。

We accept that our products need to deliver clear benefit for our customers and accept that we should not be rewarded when they do not. We have value-based contracts in place with a number of payers already and expect to do more. While the regulatory environment is complex in this area today, making each individual contract challenging and time-consuming to put in place, we would expect to see more and more value-based contracts arise as one of the ways of enabling more patients to gain access to the right innovative medicines for their ailments of the right time. We don't have all the solutions, obviously, at Amgen but we're committed to working with others to address challenges and approve the short- and long-term health of our society as a whole.

我們認同我們的產品必須為客戶帶來明顯的利益，也認同當產品沒有帶來利益時，我們不應該獲得獎勵。我們已經與多家支付方簽訂了基於價值的合同，並希望未來能與更多支付方簽訂此類合約。儘管目前該領域的監管環境十分複雜，使得每份合約的簽訂都充滿挑戰且耗時，但我們預計，隨著越來越多的患者能夠在合適的時間獲得適合自身疾病的創新藥物，基於價值的合約將會越來越多地出現。顯然，安進公司並沒有所有的解決方案，但我們致力於與他人合作，共同應對挑戰，並維護我們整個社會的短期和長期健康。

Shifting gears, we have a strong balance sheet and the flexibility and willingness to invest in external innovation. We are active in our review of opportunities, principally in our core therapeutic categories and we're disciplined as to the price that we will pay for assets. Of late, we've seen better opportunities to create value with earlier stage assets. For example, in immuno-oncology, which is of course a focus area for us, we expanded our arsenal during the quarter with a collaboration with Advaxis, as well as through the re-acquisition of a BiTE molecule to the BCMA target for multiple myeloma from Boehringer Ingelheim. We also expanded our cardiovascular franchise with an early-stage collaboration with Arrowhead.

換個角度來說，我們擁有強勁的資產負債表，並且有靈活性和意願投資外部創新。我們積極評估各種機會，主要集中在我們的核心治療領域，我們對資產的收購價格非常謹慎。最近，我們看到了利用早期資產創造價值的更好機會。例如，在免疫腫瘤學領域（這當然是我們重點關注的領域），我們在本季度透過與 Advaxis 的合作以及從勃林格殷格翰重新收購針對多發性骨髓瘤 BCMA 靶點的 BiTE 分子，擴大了我們的武器庫。我們也與 Arrowhead 展開了早期合作，拓展了我們的心血管業務。

Wrapping up, I would offer that the long-term prospects of our business are bright and I want to thank our teams around the world for their continuing focus on serving patients. David?

最後，我想說，我們業務的長期前景一片光明，我要感謝我們世界各地的團隊一直以來對服務患者的專注。大衛？

Okay. Thanks, Bob. Turning to the third-quarter financial results on page 6 of the slide deck, revenues at $5.8 billion grew 2% year over year. This quarter we saw steady product sales performance anniversarying against a strong third quarter comparison to last year. Other revenues at $295 million increased $88 million versus the third quarter of 2015. Other revenue benefited primarily from milestone payments, notably a milestone received related to the approval of KYPROLIS in Japan.

好的。謝謝你，鮑伯。翻到投影片第 6 頁的第三季財務業績，營收為 58 億美元，年增 2%。本季產品銷售業績維持穩定，與去年同期相比，第三季業績強勁成長。其他收入為 2.95 億美元，比 2015 年第三季增加了 8,800 萬美元。其他收入主要受益於里程碑付款，特別是與 KYPROLIS 在日本獲得批准相關的里程碑付款。

Changes in foreign exchange had less than a 1% negative impact to total revenue in product sales in the quarter on a year-over-year basis. Non-GAAP operating income at $2.9 billion grew 9% from prior year. Non-GAAP operating margin improved by over four points to 52.9% for the quarter, reflecting continued revenue performance and favorable expense impacts from our transformation initiatives across all operating expense categories. On a non-GAAP basis, cost of sales as a percent of product sales improved by 0.5 points to 13%, driven by manufacturing efficiencies and higher net selling price, partially offset by product mix.

外匯變動對本季產品銷售總收入較去年同期影響不到 1%。非GAAP營業收入為29億美元，較上年成長9%。本季非GAAP營業利潤率提高了4個百分點以上，達到52.9%，反映了持續的收入表現以及我們在所有營運費用類別中推行的轉型舉措帶來的有利費用影響。以非GAAP準則計算，銷售成本佔產品銷售額的百分比提高了0.5個百分點，達到13%，這主要得益於生產效率的提高和淨售價的增加，但部分被產品組合所抵消。

Research and development expenses at $963 million decreased by 11% versus last year, driven primarily by lower spending required to support certain late-stage clinical programs and transformation and process improvement efforts, partially offset by increases in upfront payment for several in-licensing transactions. SG&A expenses increased 1% on a year-over-year basis as increased commercial investments in new product launches, primarily in International markets, were enabled by savings from transformation and process improvement efforts. In total, non-GAAP operating expenses decreased 5% year over year.

研發費用為 9.63 億美元，比去年減少了 11%，這主要是由於支持某些後期臨床項目以及轉型和流程改進工作所需的支出減少，但部分被幾項引進許可交易的預付款增加所抵消。由於轉型和流程改善工作帶來的節約，使得在新產品上市（主要是在國際市場）方面的商業投資增加，因此銷售、一般及行政費用年增 1%。整體而言，非GAAP營運費用較去年同期下降5%。

Other income and expenses were a net $109 million expense in Q3. This is favorable by $38 million on a year-over-year basis. This year-over-year favorability was primarily due to gains in the third quarter from rebalancing our investment portfolio. The non-GAAP tax rate was 18.9% for the quarter, a 0.9 point increase versus Q3 of 2015. This increase reflects unfavorable changes in the geographic mix of earnings, offset by the benefit of the federal R&D credit in 2016. Non-GAAP net income increased 9% and non-GAAP earnings per share increased 11% year over year.

第三季其他收入和支出淨額為 1.09 億美元。與上年同期相比，這節省了 3,800 萬美元。這一同比利好主要歸功於第三季我們重新平衡投資組合所獲得的收益。本季非GAAP稅率為18.9%，較2015年第三季成長0.9個百分點。這一增長反映了收入地域構成不利的變化，但被 2016 年聯邦研發稅收抵免的益處所抵消。非GAAP淨利年增9%，非GAAP每股盈餘較去年同期成長11%。

Turning next to cash flow and the balance sheet on page 7, free cash flow was $2.5 billion for the quarter compared to free cash flow of $2.8 billion in the third quarter of 2015. We deployed $0.7 billion to repurchase 4.4 million shares in the quarter. Our year-to-date repurchases now total $2 billion at an average of $157 per share. We continue to plan on repurchases of up to $3 billion in total this year. Additionally, our third-quarter dividend was $1 per share, an increase of 27% over last year. In October 2016, the Board of Directors approved an increase in the share repurchase authorization to $5 billion.

接下來，我們來看第 7 頁的現金流量和資產負債表，本季自由現金流為 25 億美元，而 2015 年第三季的自由現金流為 28 億美元。本季我們投入了 7 億美元回購了 440 萬股股票。今年迄今為止，我們的股票回購總額已達 20 億美元，平均每股 157 美元。我們今年仍計劃回購總額高達 30 億美元的股票。此外，我們第三季的股息為每股 1 美元，比去年增長了 27%。2016 年 10 月，董事會批准將股票回購授權額度提高至 50 億美元。

Cash and investments totaled $38 billion, an increase of approximately $7 billion from last year's third-quarter level. This increase reflects continued solid net cash flow and the net effect of the third-quarter debt issuance. Our debt balance stands at $35.3 billion as of September 30. Our total debt portfolio has a weighted average interest rate of 3.7% and an average maturity of 12 years.

現金和投資總額為 380 億美元，比去年第三季增加了約 70 億美元。這一增長反映了持續穩健的淨現金流以及第三季債務發行的淨影響。截至9月30日，我們的債務餘額為353億美元。我們的總債務組合的加權平均利率為 3.7%，平均到期期限為 12 年。

Turning to the outlook for the business for the remainder of 2016 on page 8, we remain on track with our plans to continue investing to grow the business while transforming to a more agile and efficient operating model. Today we are increasing our 2016 guidance, which reflects continued conviction in executing our strategy and business performance through the first three quarters of this year. As a reminder, we expect to see an increase in operating expenses in Q4 versus Q3, reflecting the typical pattern for the business.

在第 8 頁，我們將展望 2016 年剩餘時間的業務前景，我們將繼續按計劃投資以發展業務，同時轉型為更靈活、更有效率的營運模式。今天，我們提高了 2016 年的業績預期，這反映了我們對今年前三個季度策略執行和業務表現的持續信心。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。

With respect to our updated guidance, our 2016 revenue guidance is now $22.6 billion to $22.8 billion versus prior guidance of $22.5 billion to $22.8 billion. Our non-GAAP earnings-per-share guidance is now $11.40 to $11.55 per share versus prior guidance of $11.10 to $11.40. Finally, we continue to expect our adjusted tax rate to be in the range of 19% to 20% and capital expenditures to be approximately $700 million this year.

關於我們更新後的業績指引，我們 2016 年的營收指引為 226 億美元至 228 億美元，而先前的指引為 225 億美元至 228 億美元。我們目前的非GAAP每股盈餘預期為每股11.40美元至11.55美元，而先前的預期為每股11.10美元至11.40美元。最後，我們仍然預計今年的調整後稅率將在 19% 至 20% 之間，資本支出約為 7 億美元。

In summary, our performance in 2016 remains on track. In this regard, we will be providing 2017 guidance in our January call. We continue to be on track to meet our commitments through 2018 based on our balanced portfolio of launch, growth and legacy products, along with a steady progress on expenses due to our transformation efforts. This concludes the financial update. I'd like to turn the call over now to Tony.

總而言之，我們2016年的表現依然符合預期。在這方面，我們將在1月的電話會議上提供2017年的指導意見。憑藉均衡的新產品、成長型產品和傳統產品組合，以及轉型努力帶來的支出穩定下降，我們將繼續按計畫履行 2018 年的承諾。財務更新到此結束。現在我想把電話交給東尼。

Thank you, David. You will find a summary of our performance for the third quarter on slide number 10. Our total revenues increased 2% year over year as we continue to drive strong volume growth, as Bob said, across several important brands, including Prolia, Sensipar, XGEVA, Nplate and Vectibix. We are bringing our new products, notably KYPROLIS and Repatha, to more patients in more markets. These gains were offset by declines in our legacy products, primarily due to competition, along with the negative impact of changes in inventory levels.

謝謝你，大衛。您可以在第 10 頁投影片上找到我們第三季的業績總結。正如鮑伯所說，隨著我們繼續推動幾個重要品牌（包括 Prolia、Sensipar、XGEVA、Nplate 和 Vectibix）的強勁銷售成長，我們的總收入年增了 2%。我們將把我們的新產品，特別是 KYPROLIS 和 Repatha，帶給更多市場中的更多患者。這些收益被我們傳統產品的下滑所抵消，這主要是由於競爭以及庫存水準變化帶來的負面影響。

In the US, our product sales declined 1% year over year and internationally product sales grew 4%, or 7% including -- excluding the impact of foreign exchange. This performance was fueled by 12% volume growth.

在美國，我們的產品銷售額年減了 1%；在國際市場，產品銷售額成長了 4%，若計入匯率影響，則成長了 7%。這一業績得益於12%的銷量成長。

Let me start with an update on how we are executing the lifecycle management strategies across our mature brands, beginning with Neulasta. Neulasta treats cancer patients who are at risk of febrile neutropenia. Each year around 100,000 patients in the US are hospitalized due to potentially fatal febrile neutropenia. Not only are these hospitalizations costly to our healthcare system and potentially devastating to patients, but also they result in potential excessive use of broad-spectrum antibiotics, which can contribute to hospital-based antibody resistance. This is a prime example of how our innovative medicines can deliver value to the healthcare system. Year over year, Neulasta declined 5% due to a small segment contraction in the US along with increased competition in our International business.

首先，讓我向大家介紹一下我們是如何在我們成熟品牌中執行生命週期管理策略的，首先從 Neulasta 開始。Neulasta 用於治療有發燒性嗜中性白血球減少症風險的癌症患者。美國每年約有 10 萬名患者因可能致命的發燒性嗜中性白血球減少症而住院。這些住院治療不僅會為我們的醫療保健系統帶來高昂的成本，而且可能對患者造成毀滅性的打擊，還會導致廣譜抗生素的過度使用，從而導致醫院內出現抗體抗藥性。這是我們的創新藥物如何為醫療保健系統帶來價值的絕佳例證。由於美國市場小幅萎縮以及國際業務競爭加劇，Neulasta 的業績年減了 5%。

We continue to see strong performance from our Onpro delivery kit in the US and are on track to exit 2016 at close to 50% market share. The Onpro delivery kit is a clear example of our commitment to innovation to improve the quality of patient care throughout the product lifecycle. Onpro improves the patient experience by eliminating the need to return to a doctor's office the day after chemotherapy for a Neulasta injection. This translates to increased value for providers, patients and payers. We expect adoption of this device to continue.

我們的 Onpro 配送套件在美國市場持續表現強勁，預計在 2016 年底達到接近 50% 的市佔率。Onpro 輸送套件清楚地體現了我們致力於在產品生命週期中不斷創新，以提高患者護理品質的承諾。Onpro 改善了患者的體驗，使患者無需在化療後第二天返回醫生辦公室接受 Neulasta 注射。這意味著對醫療服務提供者、患者和支付方而言，價值將會增加。我們預計該設備的普及率將會持續上升。

The short-acting filgrastim market in the US continued to behave as expected, with the entrance of a short-acting biosimilar in September last year. Neupogen declined 36% year over year, mainly due to this competition. We continue to compete account by account and hold 55% of the short-acting market as we exit the third quarter.

美國短效非格司亭市場持續如預期發展，去年 9 月推出了短效生物相似藥。受此競爭影響，Neupogen 的股價較去年同期下降了 36%。我們繼續逐個客戶競爭，並在第三季末佔據了短期市場 55% 的份額。

Turning to our ESA business, Aranesp increased 8% year over year, mainly due to growth in the US dialysis segment. We have successfully transferred over 80% of the ESA use in independent and midsize dialysis centers from Epogen to Aranesp. We don't expect much further transition to Aranesp moving forward.

再來看我們的 ESA 業務，Aranesp 年成長 8%，主要得益於美國透析領域的成長。我們已成功將獨立和中型透析中心的 ESA 使用量從 Epogen 轉移到 Aranesp。我們預計未來不會有太多向Aranesp過渡的跡象。

EPOGEN declined 31% year over year. The largest driver was conversion to Mircera by Fresenius, which began in earnest in the fourth quarter of 2015. We don't expect a short-acting biosimilar entrant until late next year at the earliest.

EPOGEN年減31%。最大的驅動因素是費森尤斯公司向米爾塞拉的轉換，這項轉換於 2015 年第四季正式開始。我們預計最快也要到明年年底才會出現短效生物相似藥。

Now to Enbrel, where segment growth remained strong in rheumatology and dermatology. Our primary focus is in rheumatology, which represents in excess of 80% of our business, where Enbrel offers a very competitive efficacy and safety profile as well as a strong economic value. Enbrel sales were unchanged year over year, driven by several factors. First, volume declined due to increased competition. Sequentially on a value basis we maintained share in rheumatology and lost one percentage point in dermatology. Competition in these segments continues to intensify. Secondly, we experienced a negative impact from changes in inventory levels.

接下來是恩利（Enbrel），在風濕病學和皮膚病學領域的成長依然強勁。我們的主要關注點是風濕病學，這占我們業務的 80% 以上，恩利在該領域具有非常有競爭力的療效和安全性，以及強大的經濟價值。受多種因素影響，恩利（Enbrel）的銷售額與去年同期持平。首先，由於競爭加劇，銷售量下降。以價值計算，我們在風濕病領域保持了市場份額，但在皮膚病領域下降了 1 個百分點。這些領域的競爭持續加劇。其次，庫存水準的變化對我們產生了負面影響。

Both of these dynamics were offset by positive changes in net selling price. You'll recall that changes in net selling price comprise several components, including changes to list price as well as impacts from rebates we provide to payers, including those related to their formulary decisions. Enbrel is another example of our focus on innovation, where we continue to pursue additional indications including one for children suffering from chronic moderate to severe plaque psoriasis. We're also investing in novel delivery systems to help patients with chronic inflammatory diseases to more effectively and efficiently inject themselves and ensure optimal therapy over the treatment period. We will continue to compete on a payer-contracting basis to maximize patient access to Enbrel.

淨售價的正面變化抵消了這兩種不利因素。您應該記得，淨售價的變化包括幾個組成部分，包括標價的變化以及我們向付款方提供的回扣的影響，包括與他們的處方集決定相關的回扣。Enbrel 是我們專注於創新的又一例證，我們將繼續探索更多適應症，包括用於治療患有慢性中度至重度斑塊狀乾癬的兒童。我們也正在投資新型給藥系統，以幫助患有慢性發炎性疾病的患者更有效、更有效率地進行自我注射，並確保在整個治療期間獲得最佳療效。我們將繼續透過與支付方簽訂合約的方式競爭，以最大限度地提高患者獲得恩利（Enbrel）的機會。

In highly competitive markets, PBMs can require incremental rebates from us in order for us to maintain our formulary positioning. Maintaining our formulary position is essential to ensure patients have access to a drug like Enbrel, which as has the longest in-market history of efficacy and safety. Given this dynamic and present complex negotiations, we expect relatively little benefit from net selling price changes in 2017.

在競爭激烈的市場中，藥品福利管理機構 (PBM) 可能會要求我們支付額外的回扣，以維持我們在藥品目錄中的地位。維持我們在藥品目錄中的地位至關重要，這能確保患者能夠獲得像恩利這樣的藥物，該藥物在市場上擁有最長的療效和安全性歷史。鑑於目前談判的動態性和複雜性，我們預計 2017 年淨售價變化帶來的收益相對較小。

Sensipar grew 18% year over year, driven by net selling price and strong unit growth globally. We look forward to Parsabiv's European approval and are working with the FDA to attain approval in the US.

受淨售價上漲和全球銷售強勁成長的推動，Sensipar 年成長 18%。我們期待 Parsabiv 獲得歐洲批准，並正在與 FDA 合作，爭取在美國獲得批准。

Prolia delivered strong growth of 18% year over year. Quarter over quarter, we saw the typical seasonality in quarter three with a decline of 14%. Prolia remains an important growth driver and we continue to invest to realize its full potential. Volume growth continued at nearly 20% in both the US and the EU as we continue to capture share across these markets.

Prolia實現了強勁的年成長，達到18%。與上一季相比，第三季出現了典型的季節性波動，下降了 14%。Prolia 仍然是重要的成長動力，我們將繼續投資以充分發揮其潛力。美國和歐盟的銷售量持續保持近 20% 的成長，我們不斷擴大在這些市場的份額。

XGEVA showed continued volume growth of about 7% year on year. We were pleased to see the recent result of the successful Phase 3 trial with XGEVA in multiple myeloma. About half the patients diagnosed with multiple myeloma will develop renal impairment, limiting the options for skeletal growth-related events. We look forward to bringing XGEVA to these patients, who until recently we had no other option.

XGEVA 的銷量持續保持年增，約 7%。我們很高興看到 XGEVA 在多發性骨髓瘤的 3 期試驗中取得了成功。約有一半被診斷出患有多發性骨髓瘤的患者會出現腎功能損害，這限制了與骨骼生長相關的事件的選擇。我們期待著將 XGEVA 帶給這些患者，直到最近我們才為他們帶來其他選擇。

Vectibix and Nplate continued to deliver double-digit growth, driven mainly by volume gains. Vectibix also benefited this quarter from shipments to our Japanese partner which can fluctuate throughout the year.

Vectibix 和 Nplate 持續保持兩位數成長，主要得益於銷售成長。Vectibix 本季也受惠於日本合作夥伴的出貨，而出貨量在一年中可能會有所波動。

Let me now turn to our launch products, Repatha and KYPROLIS. Both products represent substantial opportunities as they address serious diseases with significant unmet needs. Starting with our cardiovascular franchise, Corlanor helped us to establish our presence in cardiovascular space and better understand the cardiology community. Corlanor was approved to prevent re-hospitalization, one of the single largest costs in the healthcare system and thus offers a strong value proposition for chronic heart failure patients. It has also now been included in the heart failure guidelines. Nonetheless, Corlanor sales have been modest to date, as it faces steep payer hurdles. We do not expect a dramatic change in this trend in the near future.

現在讓我來介紹一下我們的首發產品，Repatha 和 KYPROLIS。這兩款產品都蘊含著龐大的市場機遇，因為它們針對的是一些尚未充分滿足的嚴重疾病治療需求。從我們的心血管特許經營業務開始，Corlanor 幫助我們在心血管領域站穩腳跟，並更好地了解心臟病學界。Corlanor 獲準用於預防再次住院，這是醫療保健系統中最大的單項支出之一，因此對慢性心臟衰竭患者來說具有很強的價值。現在它也被納入了心臟衰竭診療指南。儘管如此，由於面臨高昂的付款門檻，Corlanor 迄今為止的銷售額一直不高。我們預期這種趨勢在短期內不會發生劇烈變化。

As for Repatha, we are working with payers and providers to allow on-label patient access. We've seen some minor improvements in the utilization management criteria, but high hurdles remain for both physicians and patients to gain access. We're very pleased with the Repatha GLAGOV results, which Sean will discuss in a moment. We believe that GLAGOV, along with the expected positive outcomes data from the FOURIER study in the first quarter of 2017, will certainly strengthen Repatha's value proposition. We look forward to having these data included in our label.

至於 Repatha，我們正在與支付方和醫療服務提供者合作，以允許患者按說明書使用該產品。我們看到醫療資源利用管理標準方面有一些小的改進，但醫生和患者在獲得醫療服務方面仍然面臨很高的門檻。我們對 Repatha GLAGOV 的結果感到非常滿意，Sean 稍後會對此進行討論。我們相信，GLAGOV 研究結果，以及 2017 年第一季 FOURIER 研究的預期正面結果數據，必將增強 Repatha 的價值主張。我們期待將這些數據納入我們的標籤中。

Now to KYPROLIS. KYPROLIS grew 34% year over year as we see strong early uptake from key markets in Europe, combined with continued growth in the US. In Europe, KYPROLIS grew 30% year over year. Multiple myeloma is a dynamic market with the entrance of new competitors. In the US we've lost some share in the third line plus as a result of these new entrants.

現在來說說 KYPROLIS。KYPROLIS 年成長 34%，這得益於歐洲主要市場的強勁早期成長，以及美國市場的持續成長。在歐洲，KYPROLIS年增30%。多發性骨髓瘤市場是一個充滿活力的市場，不斷有新的競爭者加入。在美國，由於這些新進業者的出現，我們在三線及以上產品市場失去了一些份額。

However, we expect proteasome inhibitions to remain foundational therapy and we continue to grow and generate volume growth in second line as this segment grows and patients are treated longer. We're focused on growing in second line based on the strong ASPIRE and ENDEAVOR data. Both regimens - triplet and doublet - have been recognized as preferred regimens for second-line treatment in the recently updated NCCN guidelines.

然而，我們預期蛋白酶體抑制劑仍將是基礎療法，隨著二線治療領域的成長和患者接受治療時間的延長，我們將繼續發展並實現二線治療業務量的成長。基於 ASPIRE 和 ENDEAVOR 的強勁數據，我們專注於發展二線業務。在最近更新的 NCCN 指南中，三重療法和雙聯療法均被認為是二線治療的首選方案。

Let me close by thanking our customer-facing teams around the world. Their focus and agility to continue delivering for patients in this highly dynamic environment is inspirational. Let me now pass it to Sean.

最後，我要感謝我們遍佈全球的客戶服務團隊。在這種高度動態的環境中，他們依然能夠保持專注和靈活，繼續為患者提供服務，令人鼓舞。現在我把麥克風交給肖恩。

Thanks, Tony. Good afternoon. We continued to make very good progress in the third quarter, with numerous regulatory and pipeline milestones. I will begin my review with cardiovascular.

謝謝你，托尼。午安.第三季我們繼續取得了非常好的進展，在監管和研發管線方面都取得了許多里程碑式的成就。我將首先從心血管系統開始我的綜述。

In September we received results from our intravascular ultrasound study in patients with coronary artery disease on intensive statin therapy where primary and secondary endpoints were met. From a scientific standpoint, the clear demonstration of a link between the PCSK9 mechanism of action in lowering LDL cholesterol and a reduction in atherosclerotic plaque burden in patients already treated with intensive statin therapies is truly groundbreaking. We look forward to the presentation of these results at the American Heart Association meetings in New Orleans on November 15, where we will also be hosting an investor event. We are on track to review the results from our cardiovascular outcomes study in the first quarter of next year and anticipate having the data in time for presentation at the American College of Cardiology Annual Meeting in March.

9 月，我們收到了對接受強化他汀類藥物治療的冠狀動脈疾病患者進行的血管內超音波研究結果，主要終點和次要終點均已達到。從科學角度來看，PCSK9 降低 LDL 膽固醇的機制與已接受強化他汀類藥物治療的患者動脈粥狀硬化斑塊負荷減少之間的聯繫得到了清晰的證實，這確實具有突破性意義。我們期待在 11 月 15 日於新奧爾良舉行的美國心臟協會會議上公佈這些研究結果，屆時我們還將舉辦一場投資者活動。我們正按計劃於明年第一季審查心血管結果研究的結果，並預計能夠及時獲得數據，以便在 3 月的美國心臟病學會年會上進行展示。

In heart failure, we reached agreement with the FDA on the key elements of our Omecamtiv mecarbil Phase 3 cardiovascular outcome study through a special protocol assessment. This study will enroll approximately 8,000 chronic heart failure patients with reduced ejection fraction, with the primary endpoint of time to cardiovascular death or first heart failure event. We're finalizing some of the details of the protocol with global regulators and anticipate enrolling patients early next year. Omecamtiv is being developed in collaboration with Cytokinetics and Servier.

在心臟衰竭方面，我們透過一項特殊的方案評估，與 FDA 就 Omecamtiv mecarbil 3 期心血管結果研究的關鍵要素達成了一致。這項研究將招募約 8,000 名射血分數降低的慢性心臟衰竭患者，主要終點是心血管死亡或首次心臟衰竭事件發生的時間。我們正在與全球監管機構敲定該方案的一些細節，預計明年初開始招募患者。Omecamtiv 是與 Cytokinetics 和 Servier 合作開發的。

In earlier stage cardiovascular programs, we recently announced licensing and collaboration agreements with Arrowhead Pharmaceuticals to develop and commercialize RNA interference therapies for Lp(a) and another undisclosed target. Lp(a) is a target we have gained great confidence in through advanced genetic analyses performed at deCODE. We have also recently entered the clinic with an exciting new molecule for heart failure and our ASGR1 program in atherosclerosis continues to move forward in the preclinical phase.

在早期心血管計畫中，我們最近宣布與 Arrowhead Pharmaceuticals 達成許可和合作協議，以開發和商業化針對 Lp(a) 和另一個未公開目標的 RNA 幹擾療法。Lp(a) 是我們透過在 deCODE 進行的先進基因分析而對其充滿信心的目標。我們最近也帶著一種令人興奮的治療心臟衰竭的新分子進入了臨床階段，而我們治療動脈粥狀硬化的 ASGR1 計畫也在臨床前階段繼續前進。

Turning to oncology, I will begin with KYPROLIS. In Q3 we received the results of the CLARION study, which we had the opportunity to discuss at length in our conference call. I would stress that we are committed to advancing KYPROLIS into first-line therapy and we are close to finalizing a study design focused on the combination of KYPROLIS, Revlimid and dexamethasone in transplant-eligible newly diagnosed multiple myeloma patients, where we have seen very encouraging data from large investigator sponsored studies. In fact, today many of the thought leaders in the field consider KRd the standard of care for first-line patients.

談到腫瘤學，我將從 KYPROLIS 開始。第三季我們收到了 CLARION 研究的結果，我們有機會在電話會議中詳細討論了該結果。我想強調的是，我們致力於將 KYPROLIS 推進為一線療法，並且我們即將完成一項研究方案的最終確定，該方案重點關注 KYPROLIS、Revlimid 和地塞米松聯合用於適合移植的新診斷多發性骨髓瘤患者，我們已經從大型研究者發起的研究中看到了非常令人鼓舞的數據。事實上，如今該領域的許多思想領袖都認為 KRd 是第一線患者的標準治療方案。

We are also exploring other combination studies, including with some of the newer therapies and we're currently in discussions with Janssen to co-fund the study of carfilzomib in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma. We're also currently supplying drug to Janssen for their Phase 1B dose finding combination study. Before leaving KYPROLIS, I'm pleased to report we've completed enrollment in the Phase 3 study of weekly administration in the third-line setting and expect those results next year.

我們也正在探索其他聯合治療研究，包括與一些較新的療法聯合治療，目前我們正在與強生公司商討共同資助卡非佐米聯合達雷妥尤單抗和地塞米松治療復發或難治性多發性骨髓瘤患者的研究。我們目前也正在向楊森製藥公司供應藥物，用於其 1B 期劑量探索聯合用藥研究。在離開 KYPROLIS 之前，我很高興地報告，我們已經完成了三線治療中每週給藥的 3 期研究的入組，並預計明年將公佈結果。

We're also advancing a reformulated oprozomib molecule into the clinic in order to rapidly and definitively assess the potential to develop an oral proteasome inhibitor with a benefit/risk profile that would be superior to existing oral proteasome therapy.

我們也正在推進重新配製的奧普羅佐米分子進入臨床，以便快速、明確地評估開發一種口服蛋白酶體抑制劑的潛力，使其獲益/風險比優於現有的口服蛋白酶體療法。

We recently had the opportunity to review the results of the study of XGEVA in the prevention of bone complications in the multiple myeloma population and we are pleased to report the study met its primary endpoint of non-inferiority to zoledronic acid in the time to first skeletal-related event. This was expected the efficacy was similar between the agents, the renal safety profile, particularly important in the multiple myeloma population, favored the XGEVA arm. Recall that XGEVA is not currently indicated for the prevention of skeletal-related events in the multiple myeloma population and we look forward to discussing label updates with global regulators.

我們最近有機會回顧了 XGEVA 在預防多發性骨髓瘤患者骨骼併發症方面的研究結果，我們很高興地報告，該研究達到了其主要終點，即在首次發生骨骼相關事件的時間方面不劣於唑來膦酸。這也符合預期，兩種藥物的療效相似，但腎臟安全性（對於多發性骨髓瘤患者來說尤其重要）方面，XGEVA 組更勝一籌。請注意，XGEVA 目前尚未獲準用於預防多發性骨髓瘤患者的骨骼相關事件，我們期待與全球監管機構討論標籤更新事宜。

In our immuno-oncology program, BLINCYTO, our CD19 BiTE, continues to make a meaningful impact on the lives of certain ALL patients and in 3Q, the FDA expanded the indication to include the pediatric setting. The addition of the novel immunotherapy like BLINCYTO is an important advance for these patients where the use cytotoxic chemotherapies can lead to long-term consequences such as secondary malignancies. We're also initiating several Phase 3 studies of BLINCYTO in non-Hodgkin's lymphoma, including our previously announced combination study with Merck's PD1 inhibitor, KEYTRUDA.

在我們的免疫腫瘤學計畫中，我們的 CD19 BiTE 藥物 BLINCYTO 繼續對某些 ALL 患者的生活產生有意義的影響，並且在第三季度，FDA 擴大了其適應症，包括兒科領域。對於這些患者而言，使用細胞毒性化療可能會導致繼發性惡性腫瘤等長期後果，而像 BLINCYTO 這樣的新型免疫療法的加入是一項重要的進展。我們還將啟動 BLINCYTO 在非何杰金氏淋巴瘤中的幾項 3 期研究，包括我們先前宣布的與默克 PD1 抑制劑 KEYTRUDA 的聯合研究。

As we investigate the potential for IMLYGIC in combination other immunotherapies, we recently had the opportunity to present encouraging data from an interim analysis of our Phase 2 study of IMLYGIC in combination with YERVOY at the European cancer meetings ESMO. In summary, the data suggests that the combination of IMLYGIC and YERVOY has greater efficacy than either agent alone in stage IIIb-IV melanoma patients without any additional safety burden. The study is expected to complete later this year and will be submitted for presentation at the medical meeting in 2017.

當我們研究 IMLYGIC 與其他免疫療法聯合應用的潛力時，我們最近有機會在歐洲癌症會議 ESMO 上展示了 IMLYGIC 與 YERVOY 聯合應用 2 期研究的中期分析的令人鼓舞的數據。總之，數據表明，IMLYGIC 和 YERVOY 聯合用藥對 IIIb-IV 期黑色素瘤患者的療效優於單獨使用任何一種藥物，且不會增加任何額外的安全負擔。該研究預計將於今年稍後完成，並將提交給 2017 年的醫學會議進行展示。

Our combinations of studies of IMLYGIC with the anti-PD1 antibody KEYTRUDA continue to enroll. We also re-acquired the rights to AMG 420, a Phase 1 BiTE construct directed against B-cell maturation antigen, or BCMA, a multiple myeloma target that had been licensed to Boehringer Ingelheim prior to our acquisition of Micromet. Finally, we announced the preclinical collaboration with Advaxis on a unique, innovative and bespoke approach to generating immune responses against patient-specific tumor neo-antigens.

我們正在繼續招募 IMLYGIC 與抗 PD-1 抗體 KEYTRUDA 聯合治療的患者。我們也重新獲得了 AMG 420 的權利，AMG 420 是一種針對 B 細胞成熟抗原 (BCMA) 的 1 期 BiTE 構建體，BCMA 是多發性骨髓瘤的靶點，在我們收購 Micromet 之前已授權給勃林格殷格翰。最後，我們宣布與 Advaxis 進行臨床前合作，採用獨特、創新且客製化的方法，針對患者特異性腫瘤新抗原產生免疫反應。

In our bone health programs, a Phase 3 study of Prolia compared with risedronate in patients receiving glucocorticoid treatment met all primary and secondary endpoints. Glucocorticoid-induced osteoporosis is a small but medically important indication for men and women, often under the care of rheumatologists. We will discuss in a label update with regulators soon.

在我們的骨骼健康計畫中，一項針對接受糖皮質激素治療的患者進行的 Prolia 與利塞膦酸鈉的 3 期研究達到了所有主要和次要終點。糖皮質激素引起的骨質疏鬆症雖然發生率不高，但對男性和女性來說都是重要的醫學適應症，通常由風濕病學家進行治療。我們將盡快與監管機構討論標籤更新事宜。

Last month, data from the Romosozumab Phase 3 placebo-controlled fracture study, FRAME, was presented at the American society of bone and mineral research and simultaneously published in the New England Journal of Medicine. Feedback from the bone community was very positive and there's a clear desire for new innovative anabolic therapies for the treatment of osteoporosis. FDA has accepted our Romosozumab file and along with our partners at UCB we look forward to continued interactions as we work toward our July 17 PDUFA date. We also expect to conduct the primary analysis of the Phase 3 active-controlled fracture study, ARCH, in the first half of next year.

上個月，Romosozumab 3 期安慰劑對照骨折研究 FRAME 的數據在美國骨骼和礦物質研究學會上公佈，同時發表在《新英格蘭醫學雜誌》上。骨科界的回饋非常積極，並且明確表示希望有新的創新合成代謝療法來治療骨質疏鬆症。FDA 已接受我們的 Romosozumab 文件，我們期待與 UCB 的合作夥伴繼續互動，朝著 7 月 17 日的 PDUFA 日期邁進。我們也預計明年上半年進行 ARCH 3 期主動控制骨折研究的主要分析。

In neuroscience, we continue to advance our CGRP receptor antibody Erenumab for migraine prophylaxis in collaboration with Novartis. We successfully completed the first of two Phase 3 studies in episodic migraine setting. 70 milligrams of subcutaneous Erenumab administered monthly resulted in a statistically and clinically significant reduction from baseline in monthly migraine days, with a safety profile similar to placebo. We'll see the results of the second Phase 3 study in episodic migraine by the end of this year.

在神經科學領域，我們繼續與諾華公司合作，推進用於偏頭痛預防的 CGRP 受體抗體 Erenumab 的研發。我們成功完成了兩項針對發作性偏頭痛的 3 期研究中的第一項。每月皮下注射 70 毫克 Erenumab，可使每月偏頭痛天數在統計學和臨床上較基線顯著減少，且安全性與安慰劑相似。我們將在今年底看到第二項針對發作性偏頭痛的 3 期臨床試驗結果。

We also presented the positive results from our Phase 2B chronic migraine study at the European Headache and Migraine Trust International Congress. This was a robust study of more than 650 patients experiencing 18 migraine days per month at baseline. We believe the results of this study, combined with our two Phase 3 studies in episodic migraine, could support registration for both chronic and episodic migraine indications.

我們也在歐洲頭痛和偏頭痛信託國際大會上展示了我們 2B 期慢性偏頭痛研究的正面結果。這是一項嚴謹的研究，納入了 650 多名患者，這些患者在基線時每月經歷 18 天的偏頭痛。我們相信，這項研究的結果，結合我們針對發作性偏頭痛的兩項 3 期研究，可以支持該藥物註冊用於治療慢性偏頭痛和發作性偏頭痛。

And nephrology, Parsabiv received a positive opinion in Europe for the prevention of secondary hypoparathyroidism in adults with chronic kidney disease on dialysis and we look forward receiving market authorization in the EU. In the US, we are working to FDA toward approval. Finally we received our first biosimilar approval in Q3 for Amjevita, our biosimilar Humira, which was approved in all eligible indications of the reference product. We also began enrolling Phase 3 studies for our biosimilar rituximab, ABP 798, in both rheumatoid arthritis and non-Hodgkin's lymphoma and our biosimilar infliximab, ABP 710, in rheumatoid arthritis.

在腎臟病領域，Parsabiv 在歐洲獲得了積極的評價，用於預防接受透析治療的慢性腎臟病成人繼發性副甲狀腺功能減退症，我們期待在歐盟獲得市場准入許可。在美國，我們正在努力爭取獲得FDA的批准。最終，我們在第三季度獲得了首個生物相似藥批准，即 Amjevita，它是 Humira 的生物類似藥，獲準用於參考產品的所有符合條件的適應症。我們也開始招募生物相似藥利妥昔單抗 ABP 798 治療類風濕性關節炎和非何杰金氏淋巴瘤的 3 期研究患者，以及生物相似藥英夫利西單抗 ABP 710 治療類風濕性關節炎的 3 期研究患者。

As we move toward the end of the year, we still have some important work ahead of us. As always, I would like to thank our staff for their efforts to combat serious disease. Bob?

隨著年底臨近，我們還有一些重要的工作要做。和以往一樣，我要感謝我們的員工為對抗嚴重疾病所付出的努力。鮑伯？

Thank you, Sean. We would like to open the call up now to questions and I'd ask our operator to remind everybody with procedure is for asking questions. With that, let's turn it over to your questions.

謝謝你，肖恩。現在我們想開放提問環節，請我們的接線生提醒大家，提問流程是公開的。那麼，接下來就交給各位提問吧。

(Operator Instructions)

（操作說明）

Terence Flynn, Goldman Sachs.

特倫斯·弗林，高盛集團。

Hi, thanks for taking the question. Maybe just two for me. First, Bob, I was just wondering if there is a repatriation agreement under a new administration, just wondering if you could help frame for us maybe some potential uses of your cash. Sean, was wondering, on the IVUS data that we will see, can you help us think about potential implications for the ongoing CV outcomes trial with respect to potential effect sizes. Is there any correlation there? Thank you.

您好，感謝您回答這個問題。或許我只需要兩個。首先，鮑勃，我只是想知道在新政府領導下是否有遣返協議，也想知道你是否能幫我們梳理一下你這筆錢的一些潛在用途。Sean，我想問一下，關於我們即將看到的 IVUS 數據，你能否幫助我們思考一下，這些數據對於正在進行的 CV 結果試驗的潛在影響，特別是潛在的效應大小。這兩者之間是否有相關性？謝謝。

Thanks for your question. Why don't I ask David to address your question on repatriation. Obviously, you know we're supportive of corporate tax reform and in particular reform that would enable us to think about that cash, but David, why don't you address the question and we'll have Sean talk about IVUS.

謝謝你的提問。不如我請大衛來回答你關於遣返的問題。顯然，我們支持企業稅改革，特別是能夠讓我們考慮如何利用這筆現金的改革，但大衛，不如你先回答這個問題，我們再讓肖恩談談IVUS。

Certainly. I think the first point, of course, is that we continue to generate very solid and stable cash flow for the business and what we have seen thus far is that we are able to fund all of the requirements of the business without having to repatriate the cash and pay a current very unfavorable tax rate. I think the point is, is should see tax reform in the US, would we consider to repatriate the cash? I would say yes and what we would look at would be first to maintain the lowest weighted average cost of capital for the Company. That could involve repaying some of the debt that we have on the balance sheet but maintaining a pretty healthy net debt position for the Company.

當然。我認為第一點當然是，我們繼續為公司創造非常穩健的現金流，而且到目前為止，我們看到的是，我們能夠滿足公司的所有需求，而無需將現金匯回國內並支付目前非常不利的稅率。我認為關鍵在於，如果美國進行稅制改革，我們會考慮將資金匯回國內嗎？我會說是的，我們首先要考慮的是保持公司最低的加權平均資本成本。這可能包括償還我們資產負債表上的一些債務，但要維持公司相當健康的淨債務狀況。

Then we would look at certainly deploying cash, as Bob was saying, towards external opportunities, but in that instance we would certainly lead with other strategic opportunities that make sense where we could get a return for our own shareholders from such investments. Finally, we would look at potentially buying back shares to again get to the right and balanced weighted average cost of capital.

那麼，正如鮑伯所說，我們當然會考慮將現金投入外部機會中，但在這種情況下，我們肯定會優先考慮其他有意義的策略機會，以便從這些投資中為我們自己的股東帶來回報。最後，我們會考慮回購股票，以再次達到正確且平衡的加權平均資本成本。

With regard to the IVUS results and reading them through to CV outcomes, there's obviously no formula for that. What I would say is that the scientific hypothesis behind the program is that we would see a similar impact on atherosclerotic disease and hence, outcome measures from lowering LDL by a given amount with this mechanism as we would if we did it with a statin. Obviously, here patients are already maxed out on statin therapy and you are doing something you otherwise you could not do, which is to lower LDL substantially beyond that. The hypothesis would be that you would see a reduction in the impact of atherosclerotic disease that would be generally similar because the mechanisms are very similar.

至於 IVUS 結果以及如何將其解讀為 CV 結果，顯然沒有公式可循。我想說的是，該計劃背後的科學假設是，透過這種機制將 LDL 降低一定量，會對動脈粥狀硬化疾病以及相應的結果指標產生與使用他汀類藥物類似的效果。顯然，這裡的患者已經達到了他汀類藥物治療的極限，而你正在做一件你原本無法做到的事情，那就是大幅降低低密度脂蛋白膽固醇。假設動脈粥狀硬化疾病的影響會減輕，而且這種減輕總體上會相似，因為其機制非常相似。

I think that the positive IVUS study increases one's confidence about that hypothesis substantially. As you know, the human genetics which we tended to focus on a lot here at Amgen were very strongly indicative of that already, but the IVUS data give us much more confidence. I generally expect to see something that's generally similar to what you might expect to see if you are reducing LDL in PCSK9 outcome trial with, were possible to do so on top of existing maxed-out statin therapy, with a statin. That's how I think about it.

我認為，積極的血管內超音波檢查結果大大增強了人們對該假設的信心。如您所知，我們在安進公司一直非常關注的人類遺傳學已經非常有力地表明了這一點，但 IVUS 數據給了我們更大的信心。我通常預期會看到一些與在 PCSK9 結果試驗中降低 LDL 時所預期看到的情況大致相似，如果能夠在現有最大劑量的他汀類藥物治療的基礎上，再使用他汀類藥物進行治療的話。我也是這麼想的。

Let's take the next question and just a gentle reminder that if you can please limit yourself to just one question. That way we can be sure that we get to everybody's questions. Let's go onto the next question, please.

我們來看下一個問題，再次溫馨提醒一下，請盡量只提一個問題。這樣我們就能確保每個人的問題都能得到解答。請進入下一個問題。

Matthew Harrison, Morgan Stanley.

馬修·哈里森，摩根士丹利。

Great, thanks for taking the question. If I can ask two related questions on Enbrel, hopefully that doesn't get in Arvind's way. First, Tony, you talked about expected little benefit from net selling prices in 2017. I'm wondering if you can just expand on that and tell us if there's a certain amount of price increase that you are expecting when you make that comment or if the contracts you've written have certain price protections where no matter how much list price you take you won't see much net price. Just related to that, can you tell us exactly what the dollar amount of the inventory headwind was in the third quarter? Thanks.

太好了，謝謝你回答這個問題。如果我可以問兩個關於恩利（Enbrel）的相關問題，希望不會打擾到Arvind。首先，東尼，你曾說過預計 2017 年淨售價不會帶來多少收益。我想請您詳細說明一下，您在發表那番言論時是否預期會有一定幅度的價格上漲，或者您簽訂的合約中是否有價格保護條款，無論標價是多少，最終的淨價都不會很高。關於這一點，您能否告知我們第三季庫存逆風的具體金額是多少？謝謝。

Let me start with the last one first. The inventory build was about $108 million, was the differential. From the net selling price, obviously we've never given product-specific price guidance and/or -- the contracts themselves are confidential. Clearly my statement around that there will be little impact on the net selling price changes is indicative of we'll be driving the business on volume, not on net selling price next year.

讓我先從最後一個開始。庫存增加額約為 1.08 億美元，這就是差額。從淨售價來看，顯然我們從未給出過具體的產品價格指導，而且合約本身也是保密的。顯然，我關於淨售價變化不會受到太大影響的說法表明，明年我們將依靠銷量而不是淨售價來推動業務發展。

Let's go onto the next one.

我們來看下一個。

Eric Schmidt, Cowen and Company.

Eric Sc​​hmidt，Cowen and Company。

To follow up on the same topic for Tony, are you suggesting that you've been able to contract in a better way in terms of volumes and we won't continue to see the mid- to high-single-digit volume erosions for Enbrel the we've seen over the course of this year?

關於托尼剛才提到的那個話題，你的意思是說，你們在銷量方面已經能夠更好地控制銷量，我們不會再看到恩利（Enbrel）銷量像今年以來那樣出現中高個位數的下滑嗎？

No. Volume is always driven by demand in the marketplace. What I'm saying is the contracts per se will result in little impact on net selling price.

不。銷量始終由市場需求驅動。我的意思是，合約本身對淨售價的影響很小。

Eun Yang, Jefferies.

楊恩，傑富瑞集團。

Thank you. Question on AMG 820. You had this product in development for a while, but it was quiet until you did the deal with -- a collaboration with Merck. I want to ask you what is your view on anti-CSF1R potentially in IO combination and what tumor types you think would benefit the most from this combination?

謝謝。關於AMG 820的問題。你們已經研發這款產品一段時間了，但直到與默克公司達成合作協議後，才有了動靜。我想請問您對抗 CSF1R 在免疫腫瘤聯合治療的潛在應用有何看法？您認為哪些類型的腫瘤最能從這種合併治療中獲益？

This is of course for people who are not the cognoscenti in this area, it is an antibody that would address the role of tumor macrophages in maintaining a microenvironment for tumors. There's a lot of very non-causal indirect evidence to suggest that those macrophages do play an important role in tumor genesis and maintaining surveillance -- evading the surveillance of the immune system. It's, I think, a very interesting target and something that one could imagine being synergistic with checkpoint inhibition.

當然，這是為那些並非該領域專家的人準備的，這是一種可以解決腫瘤巨噬細胞在維持腫瘤微環境中的作用的抗體。有許多非因果性的間接證據表明，這些巨噬細胞在腫瘤發生和維持監視（逃避免疫系統的監視）中確實發揮著重要作用。我認為這是一個非常有趣的目標，可以想像它與檢查點抑制有協同作用。

There are, of course, tumor types that tend to have much more infiltration of these macrophages and where you can demonstrate in fact that prognosis is related to in individual patients by the numbers or density of these infiltrating macrophages. We've tended to focus on some of those tumor types. I would not necessarily get into on the this call exactly what tumor types we are exploring, because we are doing -- we are in early stages so we are looking at lots of different tumor types and mixed population studies. It is very interesting program.

當然，有些腫瘤類型往往會有更多的巨噬細胞浸潤，而且實際上可以證明，在個別患者中，預後與這些浸潤巨噬細胞的數量或密度有關。我們往往更關注某些類型的腫瘤。我不打算在這次電話會議上詳細說明我們正在研究哪些腫瘤類型，因為我們目前還處於早期階段，所以我們正在研究許多不同的腫瘤類型和混合人群研究。這是一個非常有趣的節目。

Michael Yee, RBC Capital Markets.

Michael Yee，加拿大皇家銀行資本市場。

Thanks for the question. Sean, wanted to ask on romosozumab now that you've presented more data and it seems to be well on progress. The importance of the upcoming active-controlled study, what's your expectation for what happens there and the importance of it in the regulatory filing, presuming the FDA would want to see it. Do you think the regulatory decision is an efficacy question or a safety question and how do you think about what it is going on there? Thanks so much.

謝謝你的提問。Sean，我想問關於 romosozumab 的問題，既然你已經公佈了更多數據，而且看起來進展順利。即將進行的活性對照研究的重要性，您對該研究的結果有何預期，以及它在監管文件中的重要性（假設FDA希望看到它）。您認為監理機關的決定是療效問題還是安全性問題？您如何看待這件事？非常感謝。

Right, so from a regulatory perspective, there's absolutely no requirement for such a study. A placebo-controlled fracture trial, large placebo-controlled fracture trial that meets the guidances that exists in this field is sufficient for registration all over the world. We have made a strategic decision to file in some parts of the world with both studies and that has to with payer access determinations and so on. I think that you are right that of course any time we do studies on our products, regulators are interested to see them, mainly to be -- and we often are interested in getting those changes into the label or they are interested in them from a safety perspective and so on.

沒錯，從監管角度來看，完全沒有進行此類研究的要求。符合該領域現有指南的大型安慰劑對照骨折試驗足以在世界各地註冊。我們已做出策略決定，在世界某些地區同時提交這兩項研究，這與支付方准入決定等有關。我認為你是對的，當然，每當我們對產品進行研究時，監管機構都會很感興趣地查看這些研究結果，主要是因為他們——我們通常也希望將這些更改納入標籤，或者他們從安全角度等角度對這些更改感興趣。

I think that one thing we have to recognize is that this study is designed to be analyzed first based on a time-driven basis and that's what we are talking about when we talk about the primary analysis that comes from the first half of next year. Then because we never are sure about the event rate that we are going to experience in these kind of trials, there's an event-driven analysis for example for non-vertebral fracture, which would come later if we don't hit it based on the time-based analysis, so that's important to understand.

我認為我們必須認識到的一點是，這項研究的設計初衷是首先基於時間驅動的方式進行分析，而這正是我們所說的明年上半年的主要分析。由於我們永遠無法確定這類試驗中將會發生的事件發生率，因此，例如對於非椎體骨折，會進行事件驅動分析。如果我們在基於時間的分析中沒有達到預期結果，那麼事件驅動分析就會在之後進行。所以理解這一點很重要。

Then finally, I would say that this is a very high hurdle. No one's done an active-controlled fracture trial like this before that's actually powered and designed to actually show fractured results from the get go. It produces a high hurdle. It was our feeling that we needed to be able to demonstrate that the product could be superior to a strategy of using alendronate, so that is the idea behind having the second study. Largely, again, to work with payers.

最後，我認為這是一個非常高的門檻。以前沒有人做過像這樣的主動控制骨折試驗，這種試驗從一開始就真正有足夠的力量和設計來顯示骨折結果。它設置了一個很高的障礙。我們當時覺得，我們需要證明該產品優於使用阿崙膦酸鈉的策略，這就是我們進行第二項研究的初衷。再次強調，主要還是為了與付款者合作。

Geoffrey Porges, Leerink Partners.

Geoffrey Porges，Leerink Partners。

Thank you very much. I'm sorry to keep persisting on this Enbrel question, but this quarter revenue was obviously flat. You did have the one-time effect but units were down 7% and you commented that if you look at year over year, list price was up 26% or so, certainly above 20%. Are we to assume then that your list price increases more or less completely given up in the contracts that you are now engaged in. Just related to that, could you give us an example of some of the value-based contracts and how much of your business is involved in such contracts now? Just trying to understand what that will mean.

非常感謝。很抱歉我一直追問恩利（Enbrel）的問題，但很明顯，本季的營收持平。雖然確實產生了一次性影響，但銷量下降了 7%，而且你評論說，如果按年計算，標價上漲了 26% 左右，肯定超過 20%。那麼我們是否可以認為，在您目前簽訂的合約中，您的標價上漲幅度已經或多或少完全放棄了？關於這一點，您能否舉例說明一些基於價值的合同，以及貴公司目前有多少業務涉及此類合同？我只是想弄清楚這代表什麼。

Okay, so clearly the details of the contracts we are putting out are confidential, but as we think about list prices next year, we will be circumspect, clearly based on the environment. There's a lot of pressure in the highly competitive environments, specifically with the anti-TNFs, where we have to put large rebates on the table to maintain our formulary position. The large rebates are clearly impacting net selling price. Let me go back and say that as we think about 2017, we will see little impact on the net selling price for Enbrel. Demand will be driven by what happens in the marketplace and the trends are as they are in terms of the market share at the moment and in terms of the TRx's.

好的，很顯然，我們公佈的合約細節是保密的，但當我們考慮明年的定價時，我們會謹慎行事，顯然會根據市場環境而定。在競爭激烈的環境中，我們面臨著很大的壓力，尤其是在抗 TNF 藥物領域，我們必須提供大量的回扣才能維持我們在藥物目錄中的地位。大額折扣顯然對淨售價產生了影響。讓我回顧一下，展望 2017 年，我們認為 Enbrel 的淨售價不會受到太大影響。需求將由市場動態和目前的市佔率及交易量趨勢所驅動。

As regard to some of the value-based contracts we have, there is a contract in the Northeast where we've talked about a value-based contract with Repatha around a guaranteed level of lipid lowering, specifically linked to Repatha and our ability to lower lipids. We have some work on going with Corlanor in terms of re-hospitalization. We have some work that's happening both inside the US and outside the US on Prolia in terms of fractures. Those are three examples.

關於我們的一些基於價值的合同，我們在東北地區與 Repatha 簽訂了一份基於價值的合同，該合同圍繞著保證降低血脂水平展開，具體來說，該合同與 Repatha 以及我們降低血脂的能力有關。我們正在與 Corlanor 就再住院治療方面進行一些合作。我們正在美國境內外進行一些關於Prolia斷裂的研究工作。以上是三個例子。

In total, Geoff, for example in Repatha, we are getting up to two handfuls -- or sorry, to two handfuls of these contracts and as I said in my remarks, each one of these takes some time to put in place, but I think we are addressing the need in the marketplace and we would expect to continue to see more of these, not just from Amgen but others in the industry and frankly in other sectors of the healthcare economy as well. I think we're at a point where consumers, payers want to pay for what works and not for what doesn't. This is one way to address that need in the marketplace. Again, I think the products that we have, products like Prolia, products like Repatha, a number of our products of us an opportunity to offer such value-based arrangements in the market.

例如，Geoff，就 Repatha 而言，我們總共獲得了兩份這樣的合約——或者抱歉，是兩份這樣的合約。正如我在演講中所說，每份合約的落實都需要一些時間，但我認為我們正在滿足市場需求，我們預計會繼續看到更多這樣的合同，不僅來自安進，也來自業內其他公司，坦白說，也來自醫療保健經濟的其他領域。我認為我們現在所處的階段是，消費者和支付方希望為有效的服務付費，而不是為無效的服務付費。這是滿足市場需求的一種方式。再次強調，我認為我們擁有的產品，例如 Prolia、Repatha 等產品，為我們提供了一個在市場上提供這種基於價值的安排的機會。

Joshua Schimmer, Piper Jaffray.

約書亞·施默，派珀·賈弗雷。

Thanks for taking the question. I was a little surprised to hear that Corlanor was facing some significant reimbursement headwinds. Hoping you can draw a fence around that and help us understand why that is not a harbinger of difficulties and headwinds for Repatha once you have the cardiovascular outcomes data in hand for that product. Thank you.

感謝您回答這個問題。聽說科拉諾公司在報銷方面面臨一些重大阻力，我感到有些驚訝。希望您能就此劃清界限，並幫助我們理解，一旦您掌握了該產品的心血管結果數據，為什麼這不會預示著 Repatha 將面臨困難和逆境。謝謝。

Let me try and answer the question. The label we eventually got from the FDA for Corlanor was a fairly limited label that pointed to re-hospitalization only. A number of restrictions are in place by the payers and of course Corlanor has been added to the standard of care at the moment. Most of the payers are busy trying to work out do they displace the ACE inhibitor with Entresto at the moment. There's a second add on for patients who have heart rate higher than 70 who would then be eligible for Corlanor. The business to date has been limited. Access is limited and a fair amount of paperwork is required by physicians and cardiologists to get patients on Corlanor.

讓我試著回答這個問題。我們最終從 FDA 獲得的 Corlanor 標籤相當有限，僅指向再次住院治療。支付者制定了一些限制措施，當然，Corlanor 目前已被納入護理標準。目前大多數支付方都在忙著研究是否要用 Entresto 取代 ACE 抑制劑。對於心率高於 70 的患者，還有第二種附加方案，這些患者將有資格使用 Corlanor。迄今為止，該業務規模有限。獲得 Corlanor 的機會有限，醫生和心臟科醫生需要填寫大量文件才能讓患者使用 Corlanor。

The other thing just remember, of course, Josh is that this product wasn't developed at all the way we've developed Repatha and we continue to be very excited about the prospects for Repatha and the importance of the outcomes data to demonstrate to everybody why lowering LDL cholesterol with this mechanism is important. We are enthusiastic. We have a set of data for Repatha that are spectacularly consistent from start to finish. We look forward to adding the outcomes data to that.

當然，Josh，你還要記住一點，這款產品的研發方式與我們研發 Repatha 的方式完全不同，我們仍然對 Repatha 的前景感到非常興奮，並認為結果數據對於向所有人證明為什麼通過這種機制降低 LDL 膽固醇非常重要至關重要。我們充滿熱情。我們掌握了一組關於 Repatha 的數據，這些數據從頭到尾都非常一致。我們期待將結果數據也添加到其中。

John Scotti, Evercore ISI.

John Scotti，Evercore ISI。

Hi, thanks for taking my question. Arvind, thank you so much for the kind words earlier. I really appreciate it. Thank you. I wanted to ask on Omecamtiv, actually. Now that you've decided to move to Phase 3, Sean, maybe your thoughts on, I guess for everyone, the size of the opportunity, how much would this program cost? Specifically on the Phase 3 design, how long do you think it will take to enroll the trial, your thoughts?

您好，感謝您回答我的問題。Arvind，非常感謝你先前的鼓勵和讚揚。我非常感謝。謝謝。我其實想在 Omecamtiv 上問。肖恩，既然你已經決定要進入第三階段，那麼你覺得對每個人來說，這個機會有多大？這個專案需要多少錢？具體到第三階段試驗設計，您認為招募受試者需要多長時間？您有什麼想法？

Then as well as your thoughts on the practical feasibility of -- my understanding is you need to thread the needle from a PK perspective with regard to any risk of increasing systole duration at high exposure. How, practically, do you intend to address that in the Phase 3 trial? Then generally, is this an opportunity that you see as the same magnitude as Repatha or what is your thoughts on the overall size? Thank you.

此外，您還需考慮實際可行性—據我了解，您需要從藥物動力學角度權衡高暴露量下增加收縮期持續時間的風險。在第三階段試驗中，您打算如何實際解決這個問題？那麼，總的來說，您認為這是一個與 Repatha 規模相當的機會嗎？或者您對整體規模有何看法？謝謝。

What I would say is if you step back and look at chronic heart failure, it is right up there on the top of global epidemic disease burden things. It is a huge unmet need. If you compare it to an area like oncology, the amount of work that's going on in terms of innovative mechanism that are directed at heart failure, is night and day. There's very little -- for example there's absolutely no competition in this space of something that would be an inotropic positive contractile mechanism like Omecamtiv. I think there's a huge opportunity and in particular, just from a purely medical perspective, this has been the Holy Grail in heart failure is to try and get something that actually can increase the efficiency of the squeeze that the living cardiac tissue can provide without increasing myocardial oxygen demand and resulting in arrhythmic death.

我想說的是，如果你退後一步，看看慢性心臟衰竭，它在全球流行病負擔中名列前茅。這是一個巨大的未被滿足的需求。如果將其與腫瘤學等領域進行比較，就會發現，在針對心臟衰竭的創新機制方面，兩者的工作量簡直是天壤之別。例如，在這個領域，像 Omecamtiv 這樣的正性肌力收縮機制幾乎沒有競爭對手。我認為這是一個巨大的機會，特別是從純粹的醫學角度來看，治療心臟衰竭的聖杯就是找到一種能夠提高活體心肌組織收縮效率，同時又不增加心肌耗氧量，從而避免心律不整性死亡的方法。

We believe at this point we have a very compelling Phase 2 experience and a lot of very sophisticated human physiologic experiments that we have done to understand how the product is working. We understand it deeply at a molecular level. I think that the PK is an important feature and one of the reasons that it is taken us this time it has to get the product into Phase 3 is that this is classic really tough relatively narrow window small molecule drug development. We had to come up with a formulation that was well behaved and also in drug testing strategy that can be implemented in the clinic to assess. We have a titrated regimen where patients get started on a dose, then they get the blood test to see what level they are at once they are at steady state and some proportion of patients get increased to a higher dose to ensure that everybody in a therapeutic range.

我們相信，目前我們已經累積了非常令人信服的二期臨床試驗經驗，並進行了許多非常複雜的人體生理實驗，以了解該產品的工作原理。我們從分子層面對其有深刻的了解。我認為藥物動力學是一個重要的特徵，而我們這次之所以要將產品推進到 3 期臨床試驗，其中一個原因是，這是一個典型的、非常困難的、窗口期相對較窄的小分子藥物開發案例。我們必須找到一種表現良好的配方，而這種配方也適用於可以在臨床中實施的藥物測試策略進行評估。我們採用滴定方案，患者開始服用一定劑量，然後進行血液檢查，看看他們在達到穩定狀態後體內的藥物水平，然後一部分患者增加到更高的劑量，以確保每個人都處於治療範圍內。

I think we've demonstrated very convincingly that we can keep all the patients out of a range we are getting too much of the mechanism, too much pharmacodynamic affect and not enough relaxation time. Bottom line is I think it is an extremely important program and I think that it will -- these programs are inherently long term because you can't, unlike Repatha, where we could get at least onto the market from the surrogate, you have to have mortality and morbidity outcomes trial just to gain market. But I'm very pleased that we are advancing this mechanism and we have a lot of interest in heart failure throughout our whole pipeline.

我認為我們已經非常令人信服地證明，我們可以讓所有患者都避免藥物作用過強、藥效作用過大而放鬆時間不足的情況。總而言之，我認為這是一個極其重要的項目，而且我認為它將——這些項目本質上都是長期的，因為你不能像 Repatha 那樣，至少透過替代藥物進入市場，你必須進行死亡率和發病率結果試驗才能獲得市場。但我很高興我們正在推進這項機制，而且我們對整個研發管線中的心臟衰竭問題都非常感興趣。

Robyn Karnauskas, Citigroup.

Robyn Karnauskas，花旗集團。

Hi, guys, thank you. Just looking big picture of the Company, it looks like product sales have been stable for a few quarters, or about four or five quarters. Given the slow uptake of the new products, it looks like a lot of the growth here is being driven by price. How are you thinking about the importance of bringing in some inorganic growth and the magnitude of that inorganic growth, given that the new products are more slow launchers? Thank you.

嗨，各位，謝謝你們。從公司整體情況來看，產品銷售額似乎穩定了幾個季度，或者說四、五個季度。鑑於新產品的接受度較低，看來此次成長很大程度上是由價格因素所驅動的。考慮到新產品上市速度較慢，您如何看待引入一些非內生成長的重要性以及非內生成長的規模？謝謝。

Robin, as I said in my remarks, we have a strong balance sheet. I think we have a world-class business development effort. We are looking, and we have been for some time, looking at opportunities. I think it is important, particularly in an environment like this, to be disciplined about price so that we can earn a return for shareholders, not just for the target's shareholders, so we'll continue to look. Of late we have found some very interesting opportunities at the early stages, so we've done a few deals. We've got a few others we're looking at now but we will continue to look at larger opportunities. For the most part, Robyn, those will be in our six areas of focus, therapeutic focus. As we've said now for more than a year, we are looking at a wider range of opportunities than we were previously.

羅賓，正如我剛才所說，我們的資產負債表非常穩健。我認為我們擁有世界一流的業務拓展能力。我們一直在尋找機會，而且已經有一段時間了。我認為，尤其是在這種環境下，保持價格紀律非常重要，這樣我們才能為股東創造回報，而不僅僅是為目標公司的股東創造回報，所以我們會繼續尋找機會。最近我們發現了一些非常有趣的早期投資機會，所以我們達成了幾筆交易。我們目前還在考察其他幾個項目，但我們會繼續尋找更大的發展機會。羅賓，這些主要將集中在我們的六個重點領域，即治療重點。正如我們一年多來一直強調的那樣，我們正在尋求比以往更廣泛的機會。

Alethia Young, Credit Suisse.

Alethia Young，瑞士信貸。

Thanks for taking my question. I guess, can you give us some more color on the Onpro kit, what market share you have right now? Also, is the IP different than the Neulasta IP? Thanks.

謝謝您回答我的問題。我想問一下，您能否詳細介紹一下Onpro套件，以及您目前的市佔率？另外，這個IP位址和Neulasta的IP位址不一樣嗎？謝謝。

This is Tony. Let me answer that one. One, we do have IP on the Onpro kit, so it is actually different to the composition of matter patent. Number two, the average market share for the Onpro in second quarter was about 34% and we've exited the third quarter at around 44%, 45% as an average. Good growth and we believe we are on track for close to [50%](corrected by company after the call) by the end of the year.

這是托尼。讓我來回答這個問題。第一，我們確實擁有 Onpro 套件的智慧財產權，所以它實際上與物質組成專利不同。第二，Onpro 在第二季的平均市佔率約為 34%，而第三季末的平均市佔率約為 44% 或 45%。成長良好，我們相信到年底我們有望實現接近 [50%](公司在​​電話會議後進行了更正)。

Ronny Gal, Sanford Bernstein.

羅尼·加爾，桑福德·伯恩斯坦。

Thank you for taking my question. A little bit on KYPROLIS. The concern out there has been that KYPROLIS was going to kind of get squeeze between the IMID on one side and daratumumab on the other. The combination with daratumumab is kind of interesting. The question is, are you thinking about this as a trial that will look at the dara plus KYPROLIS versus dara plus an IMID or is this just against a single agent? How do you guys make the case that KYPROLIS should be used instead of any one of those two agents?

感謝您回答我的問題。簡單介紹一下 KYPROLIS。外界一直擔心 KYPROLIS 會被 IMID 和 daratumumab 夾在中間，難以獲得市場認可。與達雷妥尤單抗合併用藥有點意思。問題是，您認為這是一項試驗，旨在比較達拉非尼聯合 KYPROLIS 與達拉非尼聯合 IMID 的療效，還是僅針對單一藥物進行比較？你們如何論證應該使用 KYPROLIS 而不是那兩種代理中的任何一種？

Okay. I think that what we are thinking about is really if you imagine that a lot of patients will see drugs like an IMID and potentially Velcade in earlier lines of therapy. When you get to the relapsed refractory, which is where we are talking about the study with Janssen, at that point you are really looking at, for example, the ENDEAVOR type regimen which is KYPROLIS at a particular dose with dexamethasone, that's where we were able to demonstrate a doubling of PFS versus Velcade. That base regimen plus daratumumab is -- versus the regimen alone is what we are thinking about looking at. You can imagine that this could be an extremely attractive regimen to have KYPROLIS, dex, and daratumumab as a relapsed refractory agent available to patients who have been treated with oftentimes drugs like Revlimid and steroids and Velcade in the first-line therapy. I think that's an obvious place for us to look at that kind of combination therapy and that's what we are focused on.

好的。我認為我們正在考慮的是，想像一下，許多患者會在早期治療中看到像 IMID 和 Velcade 這樣的藥物。當涉及到復發難治性病例時，也就是我們正在討論的與 Janssen 合作的研究，那時你真正關注的是，例如 ENDEAVOR 方案，即特定劑量的 KYPROLIS 與地塞米松聯合用藥，我們能夠證明，與 Velcade 相比，PFS 可以提高一倍。我們正在考慮研究的是，基礎治療方案加上達雷妥尤單抗與單獨使用該方案相比的效果。您可以想像，對於那些在第一線治療中經常使用瑞復美、類固醇和硼替佐米等藥物治療的複發難治性患者來說，KYPROLIS、地塞米松和達雷妥尤單抗作為治療方案可能極具吸引力。我認為這是我們研究這種聯合療法的一個顯而易見的方向，也是我們目前關注的重點。

In the big picture, I would say that we will be looking -- remember how rapidly moving this field has been in multiple myeloma and how many new entrants have come in place. There's also a potential role for immunotherapy here with the checkpoint inhibitors, so we are doing studies with that. It is going to continue to be a rapidly evolving field. We remain confident that proteasome inhibition is going to be a backbone component of regimens and that because of the limitations that are inherent in trying to treat with a drug that causes the kind of peripheral neuropathy that occurs with Bortezomib will end up playing an important role in the treatment regimens, for sure.

從宏觀角度來看，我認為我們將關注——請記住多發性骨髓瘤領域發展如此迅速，以及有多少新進入者湧現。免疫療法，特別是檢查點抑制劑，在這裡也可能發揮作用，所以我們正在進行這方面的研究。它將繼續是一個快速發展的領域。我們仍然相信蛋白酶體抑制劑將成為治療方案的核心組成部分，並且由於使用會引起硼替佐米引起的周邊神經病變的藥物進行治療存在固有的局限性，因此，蛋白酶體抑制劑肯定會在治療方案中發揮重要作用。

Geoff Meacham, Barclays.

巴克萊銀行的傑夫·米查姆。

Afternoon, thanks for taking the question. A lot of questions so far on Repatha from a cost benefit from a payer perspective. Sean or Tony, I want to get your perspective on Erenumab and what you have seen with ARISE and how you view that as within the context of cost benefit. Sean, looking forward for the STRIVE study, maybe help us with how those -- that patient population may be different from a placebo response perspective. Thanks.

下午好，謝謝您回答這個問題。目前關於瑞百安（Repatha）的成本效益，從支付方的角度來看，有許多問題。Sean 或 Tony，我想了解你們對 Erenumab 的看法，以及你們在 ARISE 研究中看到的情況，並請你們從成本效益的角度來看待這個問題。Sean，我很期待 STRIVE 研究，也許你能幫我們分析一下，從安慰劑反應的角度來看，這些患者群體可能有所不同。謝謝。

Let me answer the first question around cost benefit. I would say we haven't set a price for the product yet, but from what we've seen, it is a huge unmet medical need. A large number of patients who suffer from this disease, it is debilitating disease, it takes way independence and the ability to be productive, to be productive either as a worker or as a mother or father. The available treatments on the market at the moment does not help patients as much is they would like. It causes side effects that are sometimes worse than the disease itself.

讓我先回答第一個關於成本效益的問題。我想說，我們還沒有為產品定價，但從我們目前所看到的來看，這是一個巨大的未被滿足的醫療需求。患有這種疾病的患者人數眾多，這是一種使人衰弱的疾病，它會剝奪患者的獨立性和生產能力，無論是作為工人還是作為父母。目前市面上的治療方法並不能像患者希望的那樣幫助他們。它引起的副作用有時比疾病本身更嚴重。

It is a disease that patients really know about when they have it. It is not a non-observable symptom like some other diseases. Obviously, I think our ability to take away some of these migraines, to allow people to take back their lives, will allow us to build pharmacoeconomic models to show real value when we come to market. Sean?

這是一種患者一旦患上就會深有體會的疾病。它不像其他一些疾病那樣具有無法觀察到的症狀。顯然，我認為我們有能力消除這些偏頭痛，讓人們重獲新生，這將使我們能夠建立藥物經濟學模型，從而在產品上市時展現真正的價值。肖恩？

In terms of the second Phase 3 EM study, it is very similar in design and the inclusion/exclusion criteria are extremely similar to the study that we just saw recently. I don't think there's any reason to expect big differences in things like the placebo response rate, for example, between the trials. No two trials are going be identical, but there should not be big differences.

就第二項 3 期 EM 研究而言，其設計非常相似，納入/排除標準與我們最近看到的研究極為相似。我認為沒有理由預期不同試驗之間在安慰劑反應率等方面會有太大差異。沒有兩場試驗會完全相同，但應該不會有太大差異。

Cory Kasimov, JPMorgan.

科里·卡西莫夫，摩根大通。

Good afternoon, guys, thanks for taking the question. I guess this is for Bob, maybe Tony as well. Just curious as to your views on Prop 61 in California and maybe how concerned you are about this type of movement gaining steam and further shaping the overall pricing landscape? Thanks.

下午好，各位，感謝你們回答這個問題。我想這是給鮑伯的，也許也給東尼的。我很好奇您對加州61號提案的看法，以及您是否擔心這類運動愈演愈烈，進一步影響整體價格格局？謝謝。

Thanks, Corey. It should come as no surprise to you to learn that we are opposed to Proposition 61. We think the proposition itself is flawed and so we are joined in our view by most of the major newspapers in California, a very large number of the Veterans groups as well. I think even, frankly, many of the major California public entities have also come out against Proposition 61.

謝謝你，科里。您應該不會對我們反對第61號提案感到驚訝。我們認為該提議本身存在缺陷，加州的大多數主要報紙以及許多退伍軍人團體也與我們持相同觀點。坦白說，我認為就連加州許多主要的公共機構也都反對第 61 號提案。

We are working hard to try to make sure that people understand the reasons why we don't think is in interest of the citizens of the state of California. Obviously, this is a populist topic at the moment, Cory, so we think it is important to shed light on it here in California and wherever else there might be a similar ballot initiative risk, because I think fundamentally what we support is, as I described earlier, is the role of innovative biopharmaceuticals to try and address what is the real villain here, which is the economic and social burden of serious disease. We think innovative therapies are the way to help address that problem. Any initiative that might have the unintended consequences of Proposition 61 could have to the funding of innovative R&D is something we're going to look at very carefully and share our concerns about.

我們正在努力讓人們理解為什麼我們認為這不符合加州公民的利益。顯然，科里，這目前是一個民粹主義話題，所以我們認為有必要在加州以及任何可能存在類似投票倡議風險的地方闡明這一點，因為我認為，從根本上說，我們支持的，正如我之前所描述的，是創新生物製藥在努力解決真正的罪魁禍首——嚴重疾病帶來的經濟和社會負擔方面所發揮的作用。我們認為創新療法是解決這個問題的途徑。任何可能對創新研發資金產生與第 61 號提案類似意外後果的舉措，我們都會非常仔細地研究，並表達我們的擔憂。

Ying Huang, BFA Merrill Lynch.

黃穎，BFA 美林證券。

Thanks for the question. Two quick ones from me. On a high level, do guys have any strategic interest in another product like Enbrel in rheumatology and dermatology, given that there some evolving change of the approaches in treating those disease in oral drugs? As another quick one on biosimilar Soliris, given that it is targeting a very rare disease, is a possible you could actually go through the approval process without testing the drug in patients, just in healthy volunteers? Thanks.

謝謝你的提問。我這裡快速回答兩個問題。從宏觀層面來看，鑑於口服藥物在治療風濕病和皮膚病方面的方法正在發生變化，各位對像恩利（Enbrel）這樣的風濕病和皮膚病產品是否有任何戰略興趣？關於生物相似藥Soliris，鑑於它針對的是一種非常罕見的疾病，是否有可能無需在患者身上進行藥物試驗，只需在健康志願者身上進行試驗，即可通過審批流程？謝謝。

Let me take the first one. Again, it is no surprise that we've looked through the years at a broad number of potential products to treat rheumatologic and dermatologic inflammatory diseases and we continue to do that. We have a very high bar, obviously, with Enbrel given the years of safety and efficacy data that we have for that product. We have and will continue to look at other agents. As you know, we were developing a couple on our own as well and when those no longer had the opportunity to be first or best-in-class, we moved out of them. But we will continue to look for ways to add value in inflammation. That's one of our core research focuses. With respect to your question about our biosimilar program, I don't know --

我來選第一個。多年來，我們一直在研究各種治療風濕病和皮膚發炎性疾病的潛在產品，而且我們將繼續這樣做，這並不令人意外。顯然，鑑於恩利（Enbrel）產品多年來累積的安全性和有效性數據，我們對它的要求非常高。我們已經並將繼續尋找其他代理商。如您所知，我們當時也在自主開發幾個項目，但當這些項目不再有機會成為第一或同類最佳時，我們就退出了。但我們會繼續尋找在發炎領域增加價值的方法。這是我們的核心研究重點之一。關於您提出的關於我們生物相似藥計畫的問題，我並不了解—

I think that I would be surprised as this program you are referring to is quite early in its development process and in Phase 1. I think there likely would need to be experience in the patient population.

我認為我會感到驚訝，因為你提到的這個項目還處於早期研發階段，目前是第一階段。我認為可能需要在患者群體中累積一些經驗。

Clearly, the plan we have at the moment will bring us to market at the earliest time possible within the concept of patent laws.

顯然，我們目前的計畫將在專利法的框架內，盡快將產品推向市場。

Ian Somaiya, BMO Capital.

Ian Somaiya，BMO Capital。

Wanted to get your -- a sense of your level of commitment for developing biosimilar Eculizumab. Given the amount of visibility we've had on the newer branded approaches in the complement space?

想了解您對開發依庫珠單抗生物相似藥的投入程度。鑑於我們對補品領域新興品牌策略的了解程度？

Sorry, say it again, Ian. We couldn't hear at this end which molecule you were talking about?

對不起，伊恩，你再說一次。我們這邊聽不清楚您說的是哪一種分子？

Eculizumab. Soliris.

依庫珠單抗。索利里斯。

(Multiple speakers) We have a program that we are advancing. You are aware of it, Ian, because of a regulatory filing we made at the time that the trial began. We have not said much about our intention for that molecule other than that we intend to take it through development and as Tony said, have it available as soon as the patent intellectual properties patents have lapsed and enable us to launch it. If your question is, are we serious about it, do we intend to develop a molecule, yes.

（多人發言）我們正在推動一個專案。伊恩，你之所以知道這件事，是因為我們在審判開始時提交了一份監管文件。除了表示我們打算推進該分子的研發，並像托尼所說的那樣，一旦專利知識產權到期，我們就會立即推出該分子，除此之外，我們沒有透露太多關於該分子的意圖。如果你的問題是，我們是否認真看待此事，是否打算開發某種分子，那麼答案是肯定的。

Jim Birchenough, Wells Fargo.

吉姆·伯奇諾，富國銀行。

Good afternoon. It's Nick in for Jim this afternoon. Really it's about the BiTE strategy. Obviously you've been investing in ALL. You have a Phase 2/3 study listed in non-Hodgkin's lymphoma for continuous infusion. Now you've got the BI product, which is continuous infusion and also subcutaneous administration, I believe. From one perspective, this could look like this is suboptimal delivery, but maybe you disagree with that. Can you discuss the BiTE strategy, particularly against targets were there are fully human, bispecific antibodies and cell therapies also being directed at those targets? Thanks.

午安.今天下午由尼克代替吉姆上課。其實關鍵在於BiTE戰略。顯然你一直在投資ALL。您有一項針對非何杰金氏淋巴瘤的持續輸注的 2/3 期研究。現在你們有了BI產品，我相信它既可以持續輸注，也可以皮下注射。從某個角度來看，這似乎是一種不太理想的交付方式，但也許你不同意這種觀點。您能否討論一下 BiTE 策略，特別是針對那些已有全人源雙特異性抗體和細胞療法的標靶？謝謝。

I think it's -- first of all, we currently have the ability to develop the very short half-life molecules or much longer half-life versions of these constructs and we've had that in place for some time now, so we make choices between those depending on the particular circumstances. Now obviously with a molecule like BLINCYTO that's already approved, the thing that we are doing there is looking at induction regimens where an intensive treatment with an intravenous administration for a limited period of time would be acceptable if we were going to drive people into very low minimal residual disease positive state.

我認為——首先，我們目前有能力開發半衰期非常短的分子或半衰期長得多的此類結構，而且我們已經具備這種能力一段時間了，所以我們會根據具體情況在這些分子和結構之間做出選擇。現在，對於像 BLINCYTO 這樣已經獲得批准的分子，我們顯然正在研究誘導方案，如果我們要將患者控制在極低的微小殘留病灶陽性狀態，那麼在有限的時間內進行強化靜脈給藥治療是可以接受的。

It is true that for many solid tumor settings, for example, the development that we would pursue would be with the half-life extended versions of the BiTE. In the big picture, it turns out, interestingly, that for some of these molecules, when they are being used in hematologic malignancy settings and there's a real potential for these kind of cytokine storm syndromes, the ability to actually turn the drug's infusion off and have it dissipate out of the system in a matter of minutes is a huge advantage. That is something that you need to take into account. But we do, as we develop these against targets in solid tumors, we ultimately, and even in settings like lymphoma, you may see us do something with a short acting BiTE and then follow in as sort of the next generation with the half-life extended version.

確實，例如對於許多實體腫瘤，我們所追求的研發方向是開發半衰期延長的 BiTE 版本。從整體上看，有趣的是，對於某些分子而言，當它們用於血液惡性腫瘤治療，並且確實有可能引發細胞激素風暴綜合徵時，能夠在幾分鐘內停止藥物輸注並使其從系統中消散的能力，是一個巨大的優勢。這是你需要考慮的因素。但是，隨著我們針對實體瘤標靶開發這些藥物，最終，即使在淋巴瘤等情況下，您可能會看到我們先使用短效 BiTE，然後再推出半衰期延長的下一代版本。

One thing I might also add because it relates to a comment I made in my opening remarks about our transformation, but the BiTE area is one where we're moving very rapidly internally in our ability to examine targets and incorporate them into our BiTE platform. The other thing I would note is, we see some significant opportunities from a manufacturing cost standpoint in this area that we are excited about as well, consistent with the work that we're doing in our transformation. We think this is an area that has real legs at Amgen. Let's go to the next question.

我還要補充一點，因為這與我在開場白中提到的關於我們轉型的言論有關，但BiTE領域是我們內部正在快速發展的領域，我們有能力審查目標並將其納入我們的BiTE平台。我還要指出的是，從製造成本的角度來看，我們看到了該領域一些重要的機遇，對此我們也感到非常興奮，這與我們正在進行的轉型工作是一致的。我們認為這是安進公司一個很有發展潛力的領域。我們來看下一個問題。

As it's about 15 minutes past the hour, let's take one last question, please.

現在已經過了整點15分鐘了，請容許我們回答最後一個問題。

Eric Schmidt, Cowen & Company.

Eric Sc​​hmidt，Cowen & Company。

Thanks for the last question. Just a quick one for Sean on Parsabiv. Is it reasonable to expect US approval this year? Thanks.

謝謝你最後一個問題。給肖恩簡單提一下關於 Parsabiv 的問題。今年獲得美國批准是否合理？謝謝。

We are very engaged in right now in working toward approval. It is difficult for me to anticipate it. It's obviously the FDA's decision when they are going to grant an approval. I don't want to set an expectation that, that would be this year versus early next year. I'm hoping that it is going to happen in the reasonably near future.

我們目前正全力以赴地爭取獲得批准。我很難預料到。顯然，何時批准上市是由美國食品藥物管理局（FDA）決定的。我不想讓大家預期這會是今年還是明年年初。我希望這件事能在不久的將來發生。

As you know, Eric, obviously we are thrilled with the progress we're making with that in Europe as well. Arvind, why don't you go ahead and wrap up.

艾瑞克，你也知道，我們顯然對我們在歐洲的進展感到非常興奮。阿文德，你為什麼不趕快結束呢？

Thanks, everybody. Thanks for your participation in our call. If you have any other follow-on questions, comments, topics you would like to discuss, myself and my team will be standing by for several hours, so feel free to reach out to us. Thanks again.

謝謝大家。感謝您參與我們的電話會議。如果您還有其他後續問題、評論或想討論的話題，我和我的團隊將在接下來的幾個小時內隨時待命，歡迎隨時與我們聯繫。再次感謝。

Thank you.

謝謝。

Ladies and gentlemen, this concludes Amgen's third-quarter and financial results conference call. You may now disconnect.

女士們、先生們，安進公司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。