美國安進 (AMGN) 2018 Q3 法說會逐字稿

My name is Ian, and I'll be your conference facilitator today for Amgen's Third Quarter 2018 Financial Results Conference Call. (Operator Instructions)

我叫伊恩，今天我將擔任安進 2018 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。

Excellent. Thanks, Ian. Good afternoon, everybody. Thanks for joining us today. We have a lot of ground to cover so I'll keep my comments brief. Continued execution, launch progress and pipeline advancement are some key themes that come to mind as I think about our third quarter results. To elaborate on these themes and more, I'm joined today by Bob Bradway, our Chairman and CEO. After Bob's strategic review, our CFO, David Meline, will review our financial results for the third quarter and provide updated guidance for 2018. Also joining us today is Tony Hooper. And then you'll get to hear from Murdo Gordon, our newly appointed Head of Global Commercial Operations. Following Murdo's review of product performance, our Head of R&D, Dave Reese, will provide a pipeline update.

出色的。謝謝你，伊恩。大家下午好。感謝您今天收看我們的節目。我們需要討論的內容很多，所以我盡量簡短發言。在思考我們第三季業績時，我首先想到的是持續的執行、產品發布進度和產品線推進。為了更詳細地闡述這些主題以及更多內容，今天我邀請了我們的董事長兼執行長鮑勃·布拉德韋。在鮑伯進行策略評估後，我們的財務長大衛梅林將審查我們第三季的財務業績，並提供 2018 年的最新指導。今天和我們一起做客的還有東尼胡珀。接下來，您將有機會聽到我們新任命的全球商業營運主管默多·戈登的演講。在 Murdo 對產品性能進行評估之後，我們的研發主管 Dave Reese 將提供產品線更新資訊。

We will use slides to guide our discussion today, and a link to those slides was sent separately.

今天我們將使用幻燈片來引導討論，幻燈片的連結已單獨發送。

My customary reminder, that we will use non-GAAP financial measures in today's presentation and some of the statements will be forward-looking statements. Our 10-K and subsequent filings identify factors that could cause our actual results to differ materially.

我照例提醒各位，今天的演示中我們將使用非GAAP財務指標，並且其中一些陳述屬於前瞻性陳述。我們的 10-K 及後續文件列出了可能導致我們實際業績與預期有重大差異的因素。

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

那麼，接下來我將把電話交給鮑伯。

Okay, Arvind, thank you. On today's call, I'll provide an overview of our performance in Q3, speak to the progress we're making in delivering our strategy for long-term growth and share some thoughts on the current health care environment.

好的，Arvind，謝謝你。在今天的電話會議上，我將概述我們第三季的業績，談談我們在實現長期成長策略方面取得的進展，並分享一些關於當前醫療保健環境的看法。

Let me start by acknowledging that while we're in the midst of a period of high volatility, driven by a variety of macro and political factors, our fundamental objectives of innovating for the benefit of patients and delivering for shareholders remain intact and unchanged.

首先我要承認，儘管我們正處於由各種宏觀和政治因素驅動的劇烈波動時期，但我們為患者創新並為股東創造價值的基本目標仍然完好無損，沒有改變。

Looking into the future, there are bound to be headwinds, but we're confident in our ability to navigate them from a position of strength. You see evidence of that strength reflected once again this quarter in our healthy balance sheet, strong cash flows and efficient cost structure.

展望未來，我們必然會遇到一些逆境，但我們有信心憑藉自身優勢克服這些逆境。本季度，我們健康的資產負債表、強勁的現金流和高效的成本結構再次體現了這一實力。

We've said for some time that we expected growing pressures on drug prices in our industry. We can all see that plainly today. With price under pressure, having innovative products which can deliver volume growth by meeting the needs of large numbers of patients, is ever more important.

我們早就說過，我們預期我們產業的藥品價格將面臨越來越大的壓力。今天，這一點我們都看得很清楚。在價格承壓的情況下，擁有能夠滿足大量患者需求並實現銷售成長的創新產品變得越來越重要。

We have several such products, and you can see the benefit of this in the third quarter, where our new and recently launched products had double-digit unit volume growth.

我們有好幾款這樣的產品，從第三季的業績可以看出這一點，我們新推出和最近推出的產品銷售量實現了兩位數的成長。

We believe differentiated products like Prolia, Repatha and Aimovig are for attractive long-term growth prospects. Prolia continues to build strength globally, and there continues to be large untapped potential in the area of osteoporosis. With Repatha, we're taking steps to open up access and improve patient affordability to this important therapy. Our announcements this past week are significant and reflect our commitment to lower out-of-pocket costs for patients, especially in Medicare, in order to help ensure that patients who need Repatha get Repatha.

我們相信像Prolia、Repatha和Aimovig這樣的差異化產品具有有吸引力的長期成長前景。Prolia 在全球持續發展壯大，骨質疏鬆症領域仍有巨大的未開發潛力。透過 Repatha，我們正在採取措施，讓更多人能夠獲得這種重要的療法，並提高患者的經濟承受能力。我們上週發布的公告意義重大，體現了我們致力於降低患者（尤其是醫療保險患者）自付費用的承諾，以確保需要 Repatha 的患者能夠獲得 Repatha。

Our new product story continues to unfold with Aimovig in migraine prevention. I'm sure it's not lost in you that Aimovig is off to a very strong start and in fact, is shaping up to be one of the industry's most successful recent launches, reflecting the pent-up demand that exists in this area.

我們的新產品故事仍在繼續，Aimovig 正在用於預防偏頭痛。我相信您一定注意到了，Aimovig 的開局非常強勁，事實上，它有望成為業內近期最成功的上市產品之一，這反映了該領域存在的巨大需求。

People suffering from migraine and their physicians have been waiting for years for an effective new therapy, and they've reacted very well to Aimovig.

多年來，偏頭痛患者及其醫生一直在等待一種有效的新療法，而 Aimovig 的療效非常好。

We believe biosimilars can be an important growth driver for us as well as we're now launching KANJINTI, our biosimilar to Herceptin, and AMGEVITA, our biosimilar to Humira, internationally.

我們相信生物相似藥可以成為我們重要的成長動力，因為我們現在正在國際上推出 KANJINTI（赫賽汀的生物相似藥）和 AMGEVITA（修美樂的生物相似藥）。

Our innovative pipeline is moving very quickly. As you know, we aim to allocate capital to R&D, where we believe we have innovative first-in-class molecules with the potential for large effect sizes in serious diseases.

我們創新的產品線進展非常迅速。如您所知，我們的目標是將資金投入研發，因為我們相信我們擁有創新的一流分子，這些分子有可能對嚴重疾病產生巨大的療效。

Over the past few months, we've introduced 7 such programs into the clinic. Dave Reese will talk more about these in a moment.

過去幾個月，我們已在診所引進了 7 個這樣的計畫。戴夫·里斯稍後會詳細談談這些內容。

From a capital allocation standpoint, we've continued with our share buyback and dividend increases, and we'll continue to take a disciplined approach to business development, where we believe we can create value for Amgen's shareholders.

從資本配置的角度來看，我們一直在繼續進行股票回購和提高股息，我們將繼續採取嚴謹的業務發展方式，我們相信這可以為安進的股東創造價值。

Turning to the political and policy environment for drugs in the U.S., this obviously remains very topical. We don't expect this to end anytime soon. We remain committed to working with the administration and elected officials to advance market-based reforms that will promote competition and improve access to new therapies without undermining our nation's innovative ecosystem. The U.S. leads the world in discovering new cures and treatments for serious diseases, and we believe our society benefits from embracing this innovation. If our objective is to lower health care costs and improve population health and productivity, what we need is more innovation, not less, and we need a system that ensures access to it.

就美國毒品問題的政治和政策環境而言，這顯然仍然是一個非常熱門的話題。我們預計這種情況不會很快結束。我們將繼續致力於與政府和民選官員合作，推動以市場為基礎的改革，以促進競爭並改善獲得新療法的機會，同時不破壞我們國家的創新生態系統。美國在發現治療嚴重疾病的新方法和療法方面處於世界領先地位，我們相信，接受這種創新將使我們的社會受益。如果我們的目標是降低醫療成本，提高人口健康和生產力，那麼我們需要的是更多的創新，而不是更少的創新，我們需要一個能夠確保獲得這些創新的系統。

Let me end by thanking our staff for their efforts this past quarter. I know they're working hard to finish the year on a strong note, and I'm grateful to their dedication -- or for their dedication to our mission.

最後，我要感謝全體員工在過去一個季度所付出的努力。我知道他們正在努力工作，爭取以優異的成績結束這一年，我感謝他們的奉獻精神——或者說，感謝他們對我們使命的奉獻精神。

Let me turn it over to David.

讓我把麥克風交給大衛。

Okay. Thanks, Bob. Overall, we are encouraged by our strong results on earnings in the third quarter. I'm pleased that our transformation efforts continue to enable both investment in our business and delivery of double-digit earnings per share growth as we navigate our portfolio transition.

好的。謝謝你，鮑伯。整體而言，我們對第三季強勁的獲利業績感到鼓舞。我很高興，在我們推動業務轉型的同時，我們的轉型努力繼續推動業務投資並實現兩位數的每股盈餘成長。

Turning to the financial results on Page 6 of the slide deck. Worldwide revenue at $5.9 billion in the third quarter grew 2% year-over-year. Worldwide product sales at $5.5 billion in the third quarter grew 1% year-over-year as strong unit volume growth in our new and recently launched products outpaced declines in our mature brands.

接下來請看投影片第6頁的財務表現。第三季全球營收達 59 億美元，年增 2%。第三季全球產品銷售額達 55 億美元，年增 1%，這主要得益於新產品和近期推出的產品銷售強勁成長，超過了成熟品牌銷量的下滑。

We continue to experience good volume growth in Europe at 13% in the quarter, reflecting the value of our innovative products in a market where we have experienced biosimilar competition and portfolio transition for several years.

本季我們在歐洲的銷售量持續保持良好成長，增幅達 13%，這反映了我們創新產品的價值。在這個市場中，我們經歷了生物相似藥的競爭和產品組合的轉型，這種情況已經持續了好幾年。

Other revenues at $394 million increased $74 million year-over-year, primarily due to a milestone payment received related to our Aimovig partnership with Novartis. As communicated earlier this year, we continue to expect full year other revenues to grow 15% year-over-year.

其他收入為 3.94 億美元，年增 7,400 萬美元，主要原因是收到了與我們和諾華公司 Aimovig 合作相關的里程碑付款。正如今年稍早所宣布的那樣，我們仍然預計全年其他收入將年增 15%。

Non-GAAP operating income at $3 billion declined 2% from prior year. Non-GAAP operating margin was 53.9% for the third quarter as we continue incremental investments in our products and pipeline to drive growth and maximize shareholder value.

非GAAP營業收入為30億美元，較上年下降2%。第三季非GAAP營業利潤率為53.9%，我們持續增加對產品和研發管線的投資，以推動成長並最大化股東價值。

On a non-GAAP basis, cost of sales as a percent of product sales increased by 0.3 points to 13.8%, driven by higher manufacturing cost, partially offset by lower royalty cost and the impact of Hurricane Maria-related charges in Q3 of 2017.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比上升了0.3個百分點，達到13.8%，主要原因是製造成本上升，部分被較低的特許權使用費和2017年第三季度與颶風瑪麗亞相關的費用所抵消。

Research and development expenses at $906 million or 16% of product sales increased 6% versus last year. SG&A expenses increased 11% on a year-over-year basis, primarily driven by investments in product launches and marketed product support.

研發費用為 9.06 億美元，佔產品銷售額的 16%，比去年增長 6%。銷售、一般及行政費用年增 11%，主要原因是產品發布和市場產品支援的投資。

In aggregate, third quarter non-GAAP operating expenses increased 7% year-over-year. Other income and expenses were a net $222 million expense in Q3. This is unfavorable by $164 million on a year-over-year basis due to timing of portfolio rebalancing and liquidation of marketable securities and a lower cash balance versus Q3 of 2017.

第三季非GAAP營運費用整體年增7%。第三季其他收入和支出淨額為 2.22 億美元。由於投資組合再平衡和有價證券清算的時間安排，以及與 2017 年第三季相比現金餘額較低，與上年同期相比，虧損達 1.64 億美元。

The non-GAAP tax rate was 13% for the quarter, a 6.4 point decrease versus the third quarter of 2017, due to the impacts of U.S. corporate tax reform as well as estate settlement received this quarter. Third quarter non-GAAP net income at $2.4 billion was flat year-over-year, and non-GAAP earnings per share increased 13% year-over-year for the third quarter to $3.69 per share.

本季非GAAP稅率為13%，比2017年第三季下降了6.4個百分點，這是由於美國企業稅制改革的影響以及本季​​收到的遺產結算款項所致。第三季非GAAP淨利為24億美元，與去年同期持平；第三季非GAAP每股盈餘較去年同期成長13%，達到每股3.69美元。

Turning next to cash flow and the balance sheet on Page 7. The company generated $3.1 billion of free cash flow in the third quarter of 2018 versus $3.3 billion in the third quarter of 2017, driven by timing of tax payments.

接下來，我們來看第 7 頁的現金流量和資產負債表。該公司在 2018 年第三季產生了 31 億美元的自由現金流，而 2017 年第三季為 33 億美元，這主要是由於稅款支付的時間安排所致。

We continued to provide significant cash returns to shareholders consistent with our commitment to deploy excess cash over time. Reflecting an 11% year-over-year reduction in average share count in Q3, we deployed $1.7 billion to repurchase 8.7 million shares at an average of $196 per share. Further, we have over $3 billion remaining under our current authorization, which we will continue to deploy opportunistically.

我們繼續向股東提供可觀的現金回報，這與我們承諾隨著時間的推移配置多餘現金的承諾相一致。由於第三季平均股份數量年減了 11%，我們投入了 17 億美元以每股 196 美元的平均價格回購了 870 萬股股票。此外，我們目前的授權資金還有超過 30 億美元剩餘，我們將繼續視情況靈活運用這些資金。

Lastly, our third quarter dividend increased to $1.32 per share, an increase of 15% over last year. Cash and investments totaled $29.9 billion, a decrease of $11.5 billion from the third quarter of last year. This decrease over the last 12 months was primarily driven by $20 billion of cash returned to shareholders in the form of dividends and share buybacks, partially offset by over $10 billion of free cash flow generated in the same period.

最後，我們第三季的股息增加到每股 1.32 美元，比去年增長了 15%。現金及投資總額為 299 億美元，比去年第三季減少了 115 億美元。過去 12 個月的下降主要是由於以股息和股票回購形式向股東返還了 200 億美元現金，部分被同期產生的超過 100 億美元的自由現金流所抵消。

Our net -- our total gross debt balance stands at $34.4 billion as of September 30, 2018, carrying a weighted average interest rate of 3.6% and average maturity of 11.5 years.

截至 2018 年 9 月 30 日，我們的淨負債－總債務餘額為 344 億美元，加權平均利率為 3.6%，平均到期日為 11.5 年。

Turning next to the outlook for the business for 2018 on Page 8. We remain on track with our plans to continue investing in our pipeline, building out our global presence and increasing spend in support of long-term volume growth across large patient populations while delivering solid business performance. Our revised 2018 guidance is driven by strong business performance over the first 3 quarters of the year, our confidence in solid performance in the fourth quarter and continued conviction in our strategy.

接下來，請翻到第 8 頁，看看 2018 年的業務展望。我們將繼續按計劃投資於我們的產品線，擴大我們的全球業務，並增加支出以支持在龐大的患者群體中實現長期銷售增長，同時取得穩健的業務業績。我們修訂後的 2018 年業績指引是基於今年前三個季度強勁的業務表現、對第四季度穩健業績的信心以及對我們策略的持續信念。

Our latest revenue guidance is $23.2 billion to $23.5 billion versus previous guidance of $22.5 billion to $23.2 billion for revenue. The high end of our range assumes no Sensipar generic competition for the remainder of 2018.

我們最新的營收預期為 232 億美元至 235 億美元，而先前的營收預期為 225 億美元至 232 億美元。我們高階產品系列的前提是，在 2018 年剩餘時間內不會有 Sensipar 的仿製藥競爭。

Regarding our non-GAAP earnings per share guidance, we're revising the outlook to $14 to $14.25 per share versus previous guidance of $13.30 to $14. As a reminder, we expect Q4 total operating expense to increase 12% to 15% quarter-over-quarter, reflecting the typical pattern for the business. We are reaffirming our prior non-GAAP tax guidance of 13.5% to 14.5%, and we expect capital expenditures of approximately $700 million this year.

關於我們的非GAAP每股盈餘預期，我們將預期從先前的每股13.30美元至14美元修正為每股14美元至14.25美元。提醒各位，我們預計第四季總營運支出將較上季成長 12% 至 15%，這反映了該業務的典型模式。我們重申先前的非GAAP稅收指導意見，即13.5%至14.5%，並預計今年的資本支出約為7億美元。

In summary, we are pleased that our 2018 performance remains on track as we continue investing to grow the business. We will provide 2019 guidance on our January call.

總而言之，我們很高興2018年的業績保持穩定，我們將繼續投資以發展業務。我們將在1月份的電話會議上提供2019年的指導。

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

財務更新到此結束。現在我把電話轉給默多。

Thanks, David. I'm excited to join such a special company, and my early experience here has been extremely positive. I've been impressed by the highly talented people at Amgen, along with a culture that is patient-focused. Amgen has tremendous opportunity, with highly innovative and unique products, a tradition of strong science, a rich pipeline and now commercially available biosimilars that will benefit large numbers of patients.

謝謝你，大衛。我很興奮能加入這樣一家特別的公司，而且我在這裡的初期體驗也非常好。安進公司擁有眾多才華橫溢的員工，並且以患者為中心，這給我留下了深刻的印象。安進擁有巨大的發展機遇，其產品極具創新性和獨特性，擁有強大的科學傳統、豐富的研發管線，現在已上市的生物相似藥將使大量患者受益。

Now onto Q3 performance, and you'll find information on our product sales starting on Slide 10. I'm pleased to report that despite increasing competition, we continued to deliver volume-driven sales growth in 2018. Similar to prior quarters, our international operations delivered 11% sales growth, excluding the effect of foreign exchange, which was driven by 15% volume growth.

接下來是第三季業績，您將從第 10 頁開始看到有關我們產品銷售的資訊。我很高興地報告，儘管競爭日益激烈，但我們在 2018 年繼續實現了銷售驅動的銷售成長。與前幾季類似，我們的國際業務實現了 11% 的銷售額成長（不計匯率影響），這主要得益於 15% 的銷售成長。

And if I turn to brand performance, beginning with Prolia, we delivered another outstanding quarter, with sales increasing 15% year-over-year, with 16% volume growth from share gains in both the U.S. and internationally. Repeat injection rates in the U.S. remain especially strong at over 70%. And if you recall, we do see some seasonality with Prolia demand, which held true in the third quarter this year.

如果從品牌表現來看，以 Prolia 為例，我們又取得了一項出色的季度業績，銷售額同比增長 15%，銷量增長 16%，這得益於我們在美國和國際市場的份額提升。美國的重複注射率仍然非常高，超過 70%。如果你還記得的話，我們發現 Prolia 的需求有一定的季節性，今年第三季的情況也印證了這一點。

Osteoporotic fractures represent a large burden for patients and can be very expensive to treat and result in more hospitalizations than heart attacks, strokes and breast cancer. By 2025, fragility fractures are expected to cost $25 billion in the U.S. Prolia is a novel biologic developed to address this large unmet need and is priced very competitively.

骨質疏鬆性骨折造成患者沉重的負擔，治療費用可能非常昂貴，而且導致的住院次數比心臟病、中風和乳癌還要多。預計到 2025 年，脆性骨折將對美國造成 250 億美元的損失。 Prolia 是一種新型生物製劑，旨在滿足這一巨大的未滿足需求，且定價極具競爭力。

Moving to our oncology products, starting with KYPROLIS, which grew 12% year-on-year, driven primarily by growth in our ex-U. S. business. As you will recall from the previous quarter, there was a benefit to sales due to a clinical trial purchase in Q3 which did not repeat -- sorry, in Q2, which did not repeat in Q3.

接下來談談我們的腫瘤產品，首先是 KYPROLIS，其年成長 12%，主要得益於我們在美國以外的市場的成長。美國商業。您可能還記得上一季度，由於第三季度的臨床試驗採購，銷售額有所增長，但第二季度的情況並沒有重現——抱歉，是第二季度的情況，而第二季度的情況也沒有在第三季度重現。

Our team in the U.S. is diligently executing on a strategy of emphasizing KYPROLIS' overall survival benefit, and throughout the third quarter, we have seen both new patient and total patient shares gradually increasing.

我們在美國的團隊正在努力執行一項策略，即強調 KYPROLIS 的整體生存獲益，並且在整個第三季度，我們看到新患者和總患者份額都在逐步增加。

In addition, on October 1, we received approval from the FDA to expand the label to include a more convenient once-weekly dosing option for KYPROLIS. This demonstrates Amgen's commitment to continued evidence generation and innovation to serve patients.

此外，10 月 1 日，我們獲得了 FDA 的批准，擴大了 KYPROLIS 的標籤範圍，增加了更方便的每週一次給藥方案。這體現了安進公司致力於持續產生證據和進行創新，以服務患者的承諾。

Furthermore, Amgen is committed to providing patients with next-generation innovative medicines to treat multiple myeloma, and Dave Reese will have more to say about that in his R&D update.

此外，安進致力於為多發性骨髓瘤患者提供下一代創新藥物，戴夫·里斯將在他的研發進展報告中對此進行更多闡述。

XGEVA grew 12% year-over-year, primarily from volume, as we expanded into multiple myeloma with our label update earlier this year. We continue to receive positive feedback from physicians and institutions and continue to grow share in that segment.

XGEVA 年增 12%，主要得益於銷售成長，因為我們在今年稍早更新了標籤，將產品擴展到了多發性骨髓瘤領域。我們持續收到來自醫生和醫療機構的正面回饋，並繼續擴大在該領域的市場份額。

Turning to Neulasta, sales decreased 6% year-over-year. The decline was driven by lower net selling price and a lower the unit demand due to biosimilar competition we now face in the U.S. market.

再來看 Neulasta，銷售額較去年同期下降了 6%。下降的原因是淨售價降低以及由於我們目前在美國市場面臨的生物相似藥競爭而導致的單位需求下降。

We observed a small decline in segment share and as we have seen for the past few quarters, a slight reduction in the overall market segment in the third quarter.

我們觀察到細分市場佔有率略有下降，而且正如我們在過去幾季所看到的那樣，第三季整體市場細分略有減少。

Onpro continues to represent a majority of Neulasta sales, a greater than 60% share in the U.S. We continue to believe Onpro drives a better patient experience and better adherence to therapy, which leads to lower rates of febrile neutropenia and hospitalizations. For several years, we've been preparing for a day when a biosimilar competition to Neulasta receives approval and launches. One biosimilar is in the market, and we anticipate several more by the end of next year, which will pressure Neulasta sales.

Onpro 繼續佔據 Neulasta 銷售額的大部分，在美國的市佔率超過 60%。我們仍然相信 Onpro 能帶來更好的病患體驗和更高的治療順從性，從而降低發燒性嗜中性白血球減少症和住院率。多年來，我們一直在為Neulasta的生物類似藥物獲得批准並上市的那一天做準備。目前市面上已有一款生物相似藥，我們預計到明年年底還會有幾款上市，這將對 Neulasta 的銷售帶來壓力。

We'll continue to compete account by account, and we remain confident that our experience in the long-acting G-CSF segment and established record of quality and dependable supply will serve us well.

我們將繼續逐個客戶展開競爭，並且我們仍然相信，我們在長效粒細胞集落刺激因子 (G-CSF) 領域的經驗以及在品質和可靠供應方面建立的良好記錄將對我們大有裨益。

For NEUPOGEN, we exited the third quarter holding 35% share, the short-acting segment in the U.S. As expected, biosimilars continue to gain share over time, and pricing pressure continues to intensify.

對紐寶健而言，截至第三季末，我們在美國短效生物製劑市場佔有 35% 的份額。正如預期的那樣，生物相似藥的市場份額會隨著時間的推移而繼續增長，價格壓力也會持續加劇。

Regarding Nplate, Vectibix, IMLYGIC and BLINCYTO, while smaller individually, they combine to deliver sales of $432 million in the quarter, up 10% year-over-year, with 13% volume growth.

關於 Nplate、Vectibix、IMLYGIC 和 BLINCYTO，雖然它們各自規模較小，但合計在本季度實現了 4.32 億美元的銷售額，同比增長 10%，銷量增長 13%。

Moving now to Enbrel, sales declined 5% year-over-year, with the underlying fundamentals in both dermatology and dermatology segments consistent with recent trends. This was offset by some favorable accounting adjustments.

接下來是恩利（Enbrel），其銷售額年減了 5%，皮膚科和皮膚科領域的基本面均與近期趨勢一致。但這被一些有利的會計調整所抵消。

After 20 years in the market, our commitment to patients and investment in the brand continues with positive completion of the SEAM-PsA study, the recent launch of our innovative delivery system, the ENBREL Mini touch with AutoTouch -- Mini with AutoTouch and an improved formulation. Overall, we expect the fundamental trends in volume share and net selling price to continue.

經過 20 年的市場洗禮，我們對患者的承諾和對品牌的投入仍在繼續，SEAM-PsA 研究圓滿完成，我們最近推出了創新的給藥系統 ENBREL Mini touch with AutoTouch——帶有 AutoTouch 的 Mini 以及改進的配方。總體而言，我們預計銷售份額和淨售價的基本趨勢將持續保持。

Switching to our ESA portfolio. EPOGEN declined 5% year-over-year due to lower net selling price in a category that is becoming increasingly competitive. With the potential launch of a biosimilar in the U.S., we would expect a further decline in net selling price.

切換到我們的 ESA 產品組合。由於市場競爭日益激烈，淨售價下降，EPOGEN 的銷量年減了 5%。隨著生物相似藥在美國的潛在上市，我們預計淨售價將進一步下降。

Aranesp declined 8% year-over-year, primarily driven by increased competition from a long-acting product in the independent and mid-sized dialysis organizations.

Aranesp 年減 8%，主要原因是獨立和中型透析機構中長效產品的競爭加劇。

Slide 20 provides a breakout by segment of our ESA business, which provides clarity on the size of each and performance within. Assuming that the approved EPOGEN biosimilar will launch in all segments, we're prepared to compete.

第 20 頁按 ESA 業務板塊進行了細分，清楚地展示了每個板塊的規模和績效。假設核准的 EPOGEN 生物相似藥將在所有細分市場上市，我們已做好競爭準備。

Turning now to calcimimetics. Parsabiv is launched in several markets, including the U.S., where we continue to see strong uptake at independent and mid-sized dialysis providers. Fresenius and DaVita are gradually increasing adoption. Parsabiv continues to deliver clinical benefits to patients by putting control in the hands of the health care provider, which could also drive an improved level of patient adherence.

接下來我們來談談擬鈣劑。Parsabiv 已在包括美國在內的多個市場推出，我們在美國看到獨立和中型透析服務提供者對該產品的需求持續強勁增長。費森尤斯和達維塔正在逐步擴大其應用範圍。Parsabiv 將控制權交到醫療保健提供者手中，從而持續為患者帶來臨床益處，這也有助於提高患者的依從性。

Turning to Sensipar. Sales declined 11% year-over-year with the launch of Parsabiv. The outlook for Sensipar is still uncertain given ongoing litigation. It remains possible that generic competition may enter the market at risk.

改用Sensipar。由於 Parsabiv 的推出，銷售額比去年同期下降了 11%。鑑於訴訟仍在進行中，Sensipar 的前景仍然不明朗。仿製藥進入市場仍有可能面臨風險。

Shifting gears from our innovative product portfolio. We're pleased to have launched our first commercial biosimilar products in Europe. We're excited to have launched KANJINTI, a biosimilar version of Herceptin. And earlier this month, we launched AMGEVITA, Amgen's biosimilar to HUMIRA, across a number of European countries.

轉變我們創新產品組合的策略。我們很高興在歐洲推出了首批商業化生物相似藥產品。我們很高興推出了 KANJINTI，它是赫賽汀的生物相似藥。本月初，我們在多個歐洲國家推出了安進的 HUMIRA 生物相似藥 AMGEVITA。

We have 8 additional biosimilar programs in development, and we expect this business to be an important growth driver for years to come.

我們還有 8 個生物相似藥計畫正在開發中，我們預計這項業務將在未來幾年成為重要的成長動力。

Repatha grew by 35% year-over-year as we can continue to compete effectively, with a leading share in the PCSK9 class of 62% in the U.S. and 57% in Europe. Regarding our U.S. business, we have made strong progress to improve patient access to Repatha. Despite the strides though we have made in making Repatha available to all patients who could benefit from therapy, too many of them face significant hurdles due to high co-pay expenses. In light of this, last week, we made an important decision to improve the access and affordability of Repatha, especially for Medicare Part D patients, who represent 65% of the market.

Repatha 年成長 35%，因為我們能夠繼續有效地參與競爭，在美國 PCSK9 類藥物市場中佔據 62% 的領先份額，在歐洲佔據 57% 的領先份額。關於我們在美國的業務，我們在改善患者獲得瑞百安（Repatha）的途徑方面取得了顯著進展。儘管我們在讓所有可能受益於治療的患者都能獲得 Repatha 方面取得了長足進步，但由於高昂的自付費用，許多患者仍然面臨著巨大的障礙。有鑑於此，上週我們做出了一個重要決定，以改善 Repatha 的可及性和可負擔性，特別是對於佔市場份額 65% 的 Medicare Part D 患者而言。

We've launched a new NDC at a list price of $5,850, which was the only viable option to reduce out-of-pocket costs for Medicare patients as their co-pay is calculated from the list price. This should substantially lower their out-of-pocket costs and lower the abandonment rate which is as high as 75%. Not only is this good for patients, but it's also necessary to compete.

我們推出了一款新的 NDC 產品，標價為 5,850 美元，這是降低 Medicare 患者自付費用的唯一可行方案，因為他們的共同支付是根據標價計算的。這應該能大幅降低他們的自付費用，並降低高達 75% 的放棄率。這不僅對患者有好處，也是參與競爭的必要條件。

Although the lower price may impact Repatha sales near-term as plans update, we expect to see a positive impact on volume growth as this important therapy becomes more accessible and affordable for many more patients.

儘管較低的價格可能會在短期內影響 Repatha 的銷售，因為計劃會進行調整，但我們預計隨著這種重要療法變得更加普及和價格合理，更多患者能夠獲得這種療法，銷量增長將受到積極影響。

Regarding our ex-U. S. business, we continue to maintain a majority share and continue to work with country authorities to optimize access. Overall, our priority remains to help the large population of high-risk cardiovascular patients. The cost to society of not treating these patients is unacceptable, and we continue to investigate all avenues to improve access for appropriate high-risk patients around the world.

關於我們前美國。在美國業務方面，我們繼續保持多數股權，並繼續與各國​​政府合作，以優化准入。總的來說，我們的首要任務仍然是幫助大量高風險心血管疾病患者。不治療這些患者對社會造成的損失是不可接受的，我們將繼續探索所有途徑，以改善世界各地合適的危重患者獲得治療的機會。

Now moving to Aimovig, which represents one of the strongest launches that I've seen in my experience in this industry, both within this therapeutic area and even more broadly. We've been further energized by the remarkable response from physician and patient communities due to the launch of this innovative therapy. As of the third week of October, over 12,000 health care professionals have prescribed Aimovig, resulting in over 100,000 patients starting Aimovig since launch. The services that we've set up to assist patients in gaining early access to the product have been working to resolve requests from the sizable pent-up demand in the market. As we have addressed the initial bolus of patient demand, we expect prescription activity to moderate and normalize over the coming weeks.

現在來談談 Aimovig，這是我在這個行業中見過的最強勁的上市之一，無論是在這個治療領域還是更廣泛的範圍內。這項創新療法的推出，得到了醫生和患者群體的熱烈反響，這更加鼓舞了我們。截至 10 月第三週，已有超過 12,000 名醫療保健專業人員開立了 Aimovig 處方，自上市以來，已有超過 10 萬名患者開始使用 Aimovig。我們設立的各項服務旨在幫助患者儘早獲得該產品，以解決市場上巨大的積壓需求。隨著我們應對了最初的患者需求高峰，我們預計未來幾週處方活動將趨於平穩並恢復正常。

Since our launch, 2 additional products have gained approval in the U.S. and we feel confident in our ability to compete with Aimovig's differentiated product profile.

自公司成立以來，又有 2 款產品在美國獲得批准，我們有信心與 Aimovig 的差異化產品組合競爭。

We have a first-mover advantage. And in addition, Aimovig is the first and only preventative migraine treatment that specifically blocks the receptor to CGRP. Aimovig is delivered in a simple once-monthly dose with an easy-to-use SureClick autoinjector. However, current aided awareness among patients, for whom Aimovig would be appropriate, still remains low at just above 10%. And given the debilitating nature of migraine, we've extended our patient education campaign through direct-to-consumer television advertising in the first part of Q4 as we exit the third quarter with favorable approval rates reflecting the manageable utilization management levels and co-pay levels that have been established as a result of our having priced Aimovig for access. Due to our initial success with access, patients have rapidly moved to commercial coverage.

我們擁有先發優勢。此外，Aimovig 是第一個也是唯一一個專門阻斷 CGRP 受體的預防性偏頭痛治療藥物。Aimovig 每月只需服用一次，使用方便的 SureClick 自動注射器即可。然而，目前 Aimovig 適用的患者中，有意識的輔助意識者仍然很少，僅略高於 10%。鑑於偏頭痛的嚴重性，我們在第四季度上半段透過直接面向消費者的電視廣告擴大了病患教育活動。第三季末，我們的審批率表現良好，這反映了我們透過合理定價 Aimovig 來確保患者能夠獲得治療，從而實現了可控的用藥管理水平和共同支付水平。由於我們在醫療服務取得方面取得了初步成功，患者很快就轉向了商業保險。

Migraine is a debilitating condition that continues to have a significant lasting impact on the lives of patients and society at large. Aimovig offers a new opportunity to these previously underserved patients and their loved ones to lead more normal lives.

偏頭痛是一種使人衰弱的疾病，它對患者的生活和整個社會都持續產生重大且持久的影響。Aimovig 為這些以前服務不足的患者及其親人提供了一個新的機會，讓他們能夠過上更正常的生活。

In summary, we continue to transition to a portfolio exemplified by volume-driven growth. I'm pleased with the execution and consistency of performance in 2018, and I'm excited about the opportunities in front of Amgen.

總而言之，我們將繼續轉型以銷售驅動成長為特徵的投資組合。我對 2018 年的執行情況和業績穩定性感到滿意，並對安進公司面臨的機會感到興奮。

So let me close by once again thanking the many hardworking employees of Amgen for all they do for our patients each and every day. I'd like to thank one of our most patient-focused employees, and that's Tony Hooper, who after a very successful tenure as Head of Commercial here at Amgen, is handing over a very well-run organization. Tony has been generous of his time in transitioning the commercial leadership role to me, and I'm extremely grateful for his guidance and support.

最後，我要再次感謝安進公司眾多辛勤工作的員工，感謝他們每天為我們的病人所做的一切。我要感謝我們最以病人為中心的員工之一，他就是托尼·胡珀，他在安進擔任商業主管期間取得了非常成功的成就，現在他將一個運作良好的組織移交給了我。Tony 在將商業領導角色過渡到我的過程中慷慨地投入了大量時間，我非常感謝他的指導和支持。

And with that, I'll turn it over to Dave Reese.

接下來，我將把麥克風交給戴夫‧里斯。

Thanks, Murdo. Well, as Bob mentioned, we are entering an extremely exciting phase in R&D, including 7 new early-stage clinical programs. 6 of these are within our oncology therapeutic area, and I will begin my remarks there starting with our bispecific T-cell engager platform.

謝謝你，默多。正如鮑伯所提到的，我們正進入研發領域一個極其令人興奮的階段，其中包括 7 個新的早期臨床項目。其中 6 個屬於我們的腫瘤治療領域，我將從我們的雙特異性 T 細胞銜接器平台開始我的演講。

AMG 427 is a half-life-extended BiTE that targets FLT3, a receptor that is expressed in almost all AML cells. Activating FLT3 mutations and over-expression of wild-type FLT3 are both associated with poor prognosis in the AML patients. In contrast to small-molecule inhibitors of mutant FLT3, AMG 427 targets both mutant and wild-type forms of the receptor. Also, in AML, we began enrolling a Phase I study earlier this year with AMG 673, our extended half-life CD33 BiTE, and we look forward to the opportunity to present the first in-human data from our first-generation CD33 BiTE, AMG 330, later this year.

AMG 427 是一種半衰期延長的 BiTE，靶向 FLT3，FLT3 是一種在幾乎所有 AML 細胞中表達的受體。活化型 FLT3 突變和野生型 FLT3 的過度表現均與 AML 患者的不良預後相關。與突變型 FLT3 的小分子抑制劑不同，AMG 427 可同時針對突變型和野生型受體。此外，在 AML 領域，我們今年稍早開始招募 AMG 673（一種半衰期較長的 CD33 BiTE）的 I 期研究患者，我們期待今年稍後有機會展示我們第一代 CD33 BiTE AMG 330 的首個人體試驗數據。

Having BiTEs directed against different targets on AML cells is core to our strategy of using combination or sequential therapy to eradicate the disease, which occurs in about 20,000 patients in the U.S. each year.

針對 AML 細胞上不同標靶的 BiTE 是我們採用聯合或序貫療法根除此疾病策略的核心，該疾病每年在美國約有 20,000 名患者。

Likewise, in multiple myeloma, our goal is to transform the disease through the generation of deep, durable responses and ultimately achieve a functional cure by using highly effective combinations of drugs. One foundational element is KYPROLIS, which is a potent proteasome inhibitor as demonstrated by the superior efficacy of KYPROLIS containing regimens against standards of care, including overall survival, the gold standard in oncology.

同樣，在多發性骨髓瘤中，我們的目標是透過產生深度、持久的反應來改變這種疾病，並最終透過使用高效的藥物組合來實現功能性治癒。其中一個基礎要素是 KYPROLIS，它是一種強效的蛋白酶體抑制劑，KYPROLIS 治療方案的療效優於標準治療方案，包括總存活期（腫瘤學的黃金標準）。

As Murdo mentioned, the approval of the weekly KYPROLIS regimen provides a more convenient dosing regimen of this highly potent therapy, which we hope will help serve more patients. In addition to KYPROLIS, we have a portfolio of high-potential myeloma therapeutics, including 2 that just entered the clinic: first, our CD38 bispecific antibody, AMG 424, developed in collaboration with Xencor; and second, our oral MCL-1 inhibitor, AMG 397, which we are pursuing in multiple myeloma as well as non-Hodgkin's lymphoma and AML.

正如 Murdo 所提到的，每週一次的 KYPROLIS 療法的批准為這種高效療法提供了一種更方便的給藥方案，我們希望這將有助於服務更多患者。除了 KYPROLIS 之外，我們還有一系列具有高潛力的多發性骨髓瘤治療藥物，其中包括 2 種剛進入臨床階段的藥物：首先是與 Xencor 合作開發的 CD38 雙特異性抗體 AMG 424；其次是口服 MCL-1 抑制劑 AMG 397，我們正在將其用於治療多發性骨髓瘤、非何杰金氏骨髓瘤、非何杰金氏淋巴瘤和急性髓性骨髓瘤。

You will recall that our first-in-class IV-administered small-molecule MCL-1 inhibitor is also progressing through Phase I.

您可能還記得，我們​​首創的靜脈注射小分子 MCL-1 抑制劑也正在進行 I 期臨床試驗。

Finally, we are very excited about our BCMA BiTE program, where our extended half-life molecule, AMG 701, continues to enroll in Phase I, and we are very much looking forward to the opportunity to present the initial clinical data from our first-generation BCMA BiTE, AMG 420, at a medical conference in the fourth quarter.

最後，我們對我們的 BCMA BiTE 計畫感到非常興奮，其中我們的長效半衰期分子 AMG 701 正在 I 期繼續招募患者，我們非常期待有機會在第四季度的醫學會議上展示我們第一代 BCMA BiTE AMG 420 的初步臨床數據。

Turning to precision oncology. RAS is the most frequently mutated human oncogene that has been undruggable for 35 years, therefore, we were very excited to move the first KRAS G12C inhibitor into the clinic with AMG 510. Another first-in-class clinical program is AMG 119, our CAR T directed against DLL3 for small cell lung cancer. This now gives us the unique ability to evaluate our BiTE and CAR T DLL3 programs in parallel, which will allow us to explore the optimal utilization of these therapies in small cell lung cancer, an area of significant unmet medical need. And finally, we are dosing our first patient today with AMG 562, a half-life extended version of our CD19 BiTE, BLINCYTO.

轉向精準腫瘤學。RAS 是人類最常見的突變癌基因，35 年來一直沒有藥物可以治療，因此，我們非常興奮地將第一個 KRAS G12C 抑制劑 AMG 510 推向臨床。另一個首創的臨床項目是 AMG 119，我們針對 DLL3 的 CAR-T 療法，用於治療小細胞肺癌。這使我們現在能夠並行評估我們的 BiTE 和 CAR T DLL3 項目，這將使我們能夠探索這些療法在小細胞肺癌（一個存在重大未滿足醫療需求的領域）中的最佳應用。最後，今天我們將給第一位患者註射 AMG 562，這是我們 CD19 BiTE 的半衰期延長版本 BLINCYTO。

This is a unique time at Amgen, with a number of high-potential first-in-class programs advancing through the oncology pipeline. We have designed these development programs to rapidly establish proof-of-concepts and then move into the pivotal phase so that we may get these innovative therapies to patients as quickly as possible.

對安進來說，這是一個獨特的時期，許多具有高潛力的同類首創計畫正在腫瘤治療領域穩步推進。我們設計這些研發項目是為了快速建立概念驗證，然後進入關鍵階段，以便我們能夠盡快將這些創新療法帶給患者。

I would note that we are hosting an Investor Relations event at the upcoming ASH Meeting in San Diego on Monday night, December 3, at 8:00 p.m., where we will share more on these exciting programs, and I hope to see many of you there in person.

我想指出，我們將在12月3日星期一晚上8點在聖地亞哥舉行的ASH會議上舉辦投資者關係活動，屆時我們將分享更多關於這些激動人心的項目的信息，我希望屆時能見到你們中的許多人。

Turning to our other therapeutic areas. In our neuroscience collaboration with Novartis, we continue to expect Phase II results from AMG 301, our PAC1 receptor antibody for migraine prevention, by year-end for presentation at a medical conference in 2019.

接下來，我們來看看其他治療領域。在我們與諾華的神經科學合作中，我們繼續期待在年底前獲得 AMG 301（一種用於預防偏頭痛的 PAC1 受體抗體）的 II 期臨床試驗結果，以便在 2019 年的醫學會議上進行展示。

In cardiovascular medicine, we began enrolling patients in a Phase I study of AMG 890, a novel Lp(a) small-interfering RNA therapy. Elevated Lp(a) is strongly associated with increased risk of cardiovascular disease, independent of LDL cholesterol. It has remained largely unmodifiable.

在心血管醫學領域，我們開始招募患者參與 AMG 890 的 I 期研究，AMG 890 是一種新型的 Lp(a) 小幹擾 RNA 療法。Lp(a) 水平升高與心血管疾病風險增加密切相關，且與 LDL 膽固醇無關。它基本上保持不變。

In our collaboration with Cytokinetics, a Phase III outcomes study for omecamtiv mecarbil, continues to briskly enroll heart failure patients, reflecting the enthusiasm for this approach.

我們與 Cytokinetics 合作進行的 omecamtiv mecarbil III 期療效研究正在迅速招募心臟衰竭患者，這反映了人們對這種治療方法的熱情。

We also recently filed an IND for AMG 594, a novel troponin activator for the treatment of heart failure. We look forward to advancing AMG 594 into the clinic in the near future.

我們最近也提交了 AMG 594 的 IND 申請，這是一種用於治療心臟衰竭的新型肌鈣蛋白活化劑。我們期待在不久的將來將 AMG 594 推進到臨床試驗階段。

In our inflammation collaboration with AstraZeneca, our novel first-in-class tezepelumab program that targets TSLP, an upstream modulator of multiple inflammatory pathways, continues to progress, with our Phase III study in severe uncontrolled asthma enrolling well. The potential for tezepelumab to address significant unmet need was recognized by the FDA by granting Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype.

在我們與阿斯特捷利康的發炎合作中，我們針對 TSLP（一種多種發炎路徑的上游調節劑）的新型首創 tezepelumab 計畫繼續取得進展，我們針對嚴重未控制氣喘的 III 期研究招募進展順利。FDA 認可了 tezepelumab 在解決重大未滿足需求方面的潛力，授予其突破性療法認定，用於治療無嗜酸性粒細胞表型的重度氣喘患者。

Finally, our biosimilar programs continue to advance. We are preparing our U.S. and EU regulatory submissions for ABP 710, our biosimilar, REMICADE, which we expect to occur by the first quarter of next year. We have also achieved global alignment on the study design for ABP 959, our biosimilar, Soliris, and are now in startup of the Phase III pivotal study.

最後，我們的生物相似藥計畫仍在持續進行中。我們正在準備向美國和歐盟提交 ABP 710（我們的生物相似藥 REMICADE）的監管申請，預計明年第一季完成。我們也對 ABP 959（我們的生物相似藥 Soliris）的研究設計達成了全球共識，目前正在啟動 III 期關鍵性研究。

I'll end my update there and close by thanking all of my colleagues here at Amgen who worked so hard to advance medicines that can make a real difference in the lives of patients. Bob?

我的更新就到此結束，最後我要感謝安進公司的所有同事，感謝他們為推進能夠真正改變患者生活的藥物研發所付出的辛勤努力。鮑伯？

Okay. Thank you to David. And as Arvind noted earlier, Tony Hooper is on the call with us, and though he will be at Amgen beyond year-end, this will be his last quarterly earnings call with us. This is a ritual that has been part of his life for the past 13 years. So Tony, before we start Q&A, is there anything you want to say to the listeners?

好的。感謝大衛。正如 Arvind 之前提到的，Tony Hooper 也參加了我們的電話會議，雖然他年底之後還會繼續留在安進公司，但這將是他最後一次和我們一起參加季度收益電話會議。這是他過去13年來一直堅持的儀式。東尼，在開始問答環節之前，你有什麼想對聽眾說的話嗎？

Well, Bob, thank you very much indeed. Good afternoon, folks. For those of you who have now listened to Murdo twice in the last week or so, I'm sure you understand why we are so excited about him joining the executive team at Amgen. He does bring with him decades of successful commercial experience in many of the therapeutic areas that Amgen participates in. He will also bring a set -- a fresh set of eyes to our efforts, our mission, that will help lead Amgen onto the next stage of its journey.

鮑勃，真是太感謝你了。各位下午好。在過去一周左右的時間裡，如果你已經聽過 Murdo 兩次講話，我相信你一定明白為什麼我們對他加入安進的管理團隊感到如此興奮。他在安進公司參與的許多治療領域擁有數十年的成功商業經驗。他還會帶來一套全新的視角來審視我們的努力和使命，這將有助於引領安進邁向下一個發展階段。

As Bob mentioned in our second quarter call, one of the hallmarks of a well-run company is a carefully considered succession planning process. Murdo and I are executing an orderly and planned transition. I am remaining involved to ensure that nothing falls through the cracks, so that Murdo can rapidly focus on growing revenue and defending the legacy brands.

正如鮑勃在第二季電話會議上提到的那樣，一個管理良好的公司的標誌之一是經過深思熟慮的繼任計劃流程。Murdo 和我正在執行有序且有計劃的交接工作。我將繼續參與其中，以確保萬無一失，以便 Murdo 能夠迅速專注於增加收入和捍衛傳統品牌。

I'd like to also take this opportunity to thank all the Amgen staff that I've had the pleasure to work with over my 7 years at Amgen. They're a group that sets tough goals and then delivers them. They have a passion for serving patients that is beyond words. They are also one of the most competitive groups I've ever had the pleasure to work with.

我也想藉此機會感謝我在安進工作的7年來，所有與我共事的安進員工。他們是一群設定遠大目標並努力實現目標的團隊。他們對服務患者的熱情難以言喻。他們也是我有幸合作過的最具競爭力的團隊之一。

I'd also like to thank those analysts and investors on the call today for our interactions over the years. Your challenges and your guidances have always been appreciated. Thank you very much.

我還要感謝今天參加電話會議的各位分析師和投資者，感謝我們多年來的交流。我們一直很感激您提出的挑戰和指導。非常感謝。

Okay. Thank you. With that, why don't we turn over to the Q&A. And Ian, if you'd just remind our callers of the process that we use for that purpose. Thanks.

好的。謝謝。那麼，我們接下來進入問答環節吧。伊恩，你能不能提醒一下我們的來電者，我們為此目的所採用的流程？謝謝。

(Operator Instructions) Our first question is from the line of Matthew Harrison from Morgan Stanley.

（操作員說明）我們的第一個問題來自摩根士丹利的馬修·哈里森。

I wanted to ask a question about biosimilars, if I could. So could you maybe just comment a little bit on how you view the outlook for biosimilars in Europe? Obviously, we've seen some recent TNF launches, but the HUMIRA launch is fairly competitive. And I'm just wondering, if you could comment a little bit more in detail about how you view the outlook and how you view the competitive dynamics in that market.

如果可以的話，我想問一個關於生物相似藥的問題。那麼，您能否就您如何看待歐洲生物相似藥的前景發表一下看法呢？顯然，我們最近看到了一些 TNF 的新產品發布，但 HUMIRA 的發布競爭相當激烈。我想請您更詳細地談談您對該市場前景和競爭格局的看法。

Sure, Matthew. Early days still, but we like what we see so far. As you know, we've launched our 2 products, KANJINTI and AMGEVITA. And as I said, early days, but so far so good. So we have a portfolio of 8 other molecules advancing through the clinic, and we look forward to launching those internationally as well. Murdo, you -- any incremental thoughts from you are welcome.

當然，馬修。現在還處於早期階段，但我們對目前所看到的感到滿意。如您所知，我們已經推出了兩款產品，分別是 KANJINTI 和 AMGEVITA。正如我所說，現在還處於早期階段，但目前為止一切順利。因此，我們還有 8 種其他分子正在進行臨床試驗，我們期待在國際上推出這些分子。Murdo，你－歡迎你提出任何想法。

Yes, the -- we've got more experience, obviously, with KANJINTI having been in the market for a longer period in time. We've done quite well through a series of tender processes, with particular strength in Germany. I think it's a little too early to tell with AMGEVITA, but we have obviously seen competitive activity, and it will be a competitive process but the team on the ground is very strong. The other thing to think about with the biosimilars portfolio for Amgen is, particularly as it relates to some of the oncology biosimilars in our portfolios, we will be embedding them alongside our innovative portfolio and we'll be able to explain the benefits of the Amgen quality and dependable supply to providers and reimbursement authorities around the world.

是的，顯然，KANJINTI 在市場上經營的時間更長，因此我們擁有更豐富的經驗。我們在一系列招標過程中都取得了相當不錯的成績，尤其是在德國表現強勁。我覺得現在對 AMGEVITA 下結論還為時過早，但我們顯然已經看到了他們的競爭態勢，這將是一個競爭激烈的過程，但他們的團隊實力非常強大。對於安進的生物相似藥產品組合，還有一點需要考慮，特別是對於我們產品組合中的一些腫瘤生物類似藥，我們將把它們與我們的創新產品組合一起整合，並且我們將能夠向世界各地的醫療服務提供者和醫保機構解釋安進的品質和可靠供應的優勢。

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

下一個問題來自巴克萊銀行的傑弗裡·米查姆。

And Tony, it's been great working with you. Congrats. Look, a question for Murdo and perhaps, Bob. I know it's early days in the seat, but I wanted to get, Murdo, your preliminary thoughts on strategies to grow Amgen's o-U. S. business, how much of a broader priority is this. I'm just asking because it's a much smaller component of the revenue base versus peers, but you do have assets now that can be foundational to growing o-U. S. more broadly.

托尼，和你一起工作非常愉快。恭喜。聽著，這個問題想問默多，或許也想問鮑伯。我知道你上任時間還不長，但我想聽聽 Murdo 對安進公司發展策略的初步想法。美國企業，這究竟有多重要的優先事項？我這麼問是因為與同業相比，這部分收入在公司收入基礎中所佔比例要小得多，但你們現在確實擁有一些可以作為 o-U 發展基礎的資產。更廣泛地說。

Why don't we take the answer in 2 parts, Geoff. I'll kick it off. As you know, we've been able to demonstrate double-digit volume growth now quarter after quarter in international markets. And I think that reflects the recognition of the value of our new products. And we do expect international growth to be an important part of our long-term strategy for delivering that to our shareholders. And again, I think it's still early days for us, in particular in Asia and some of the other emerging markets, but so far, we're encouraged by the results. Murdo?

傑夫，我們不妨分兩部分來回答這個問題。我先來。如您所知，我們在國際市場上已經連續幾季實現了兩位數的銷售成長。我認為這反映了市場對我們新產品價值的認可。我們預期國際成長將成為我們長期策略的重要組成部分，以此為股東創造價值。再次強調，我認為對我們來說，現在還為時過早，尤其是在亞洲和其他一些新興市場，但到目前為止，我們對結果感到鼓舞。默多？

Yes, I would echo the same remarks, Bob. And I would just add a few good events that have happened for us with the approval of Repatha in China. We have a great partnership in Japan with our partners, Astellas, and we look forward to expanding beyond that in 2020. We have great businesses across Europe, Canada, Australia and emerging businesses in the rest of the world. And it is, as it was Tony's focus, it will be my focus to continue to grow our business ex-U. S. and make the innovations from Amgen's R&D pipeline available in those markets. So we've gone from 42 countries to 102. That's a good-sized footprint for a company our size and affords us an opportunity to expand outside of the U.S.

是的，我完全同意你的看法，鮑伯。我還要補充幾件隨著瑞百安在中國獲得批准而對我們來說比較好的事情。我們與日本的合作夥伴安斯泰來製藥建立了良好的合作關係，我們期待在 2020 年進一步擴展合作關係。我們在歐洲、加拿大、澳洲擁有許多優秀的業務，並在世界其他地區擁有新興業務。而這正是東尼一直以來關注的重點，也將是我的重點，那就是繼續發展我們在美國以外的業務。並將安進研發管線中的創新成果引入這些市場。所以我們已經從 42 個國家增加到了 102 個國家。對於我們這樣規模的公司來說，這是一個相當大的佔地面積，也為我們提供了向美國以外擴張的機會。

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 want to add my congrats to Tony as well. So maybe, Bob, you can give us a little more color. Given the recent proposal from Trump administration on the recent Medicare Part B, what can Amgen do to mitigate a potential negative impact? And then second, I have a question on Aimovig. Given your current lack of differentiation in clinical data so far, how do you position Aimovig against the other 2 competing therapies in the market for the 2019 contract negotiation?

我也想向托尼表示祝賀。所以，鮑勃，或許你可以給我們補充一些細節。鑑於川普政府最近提出的關於聯邦醫療保險B部分的提案，安進公司可以採取哪些措施來減輕潛在的負面影響？其次，我有一個關於Aimovig的問題。鑑於您目前在臨床數據方面缺乏差異化優勢，您如何將 Aimovig 與市場上其他兩種競爭療法在 2019 年的合約談判中定位為競爭優勢？

Okay. Again, we'll take this in 2 parts. Why don't I start with the -- your question about the political environment and then kick it to Murdo to respond to your question about Aimovig. With respect to the proposal, I think I'd start with your question which is that, at this point, it is just a proposal. We expect there will be quite a bit of interest in trying to help shape the eventual outcome of that. But our objective and our commitment is to continue to work with the administration and Congress to try to improve the competitiveness and access for innovative drugs in our system, and that includes in Part B. We think there are some things that can be done to eliminate unnecessary cost and friction in the system and make sure the patients who need innovative therapies can get them, and we'll continue to advance those ideas in our discussions in Washington. But again, it just would underscore it's a proposal at this point, and there will be plenty of time to see the proposal take shape. Murdo, do you want to address the questions starting with the comment that there's no differentiation between the products?

好的。我們還是分兩部分來講解吧。我先回答你關於政治環境的問題，然後再把問題轉給默多，讓他來回答你關於Aimovig的問題。關於這項提議，我認為應該先回答你的問題，那就是，目前這只是一項提議。我們預計會有很多人對參與塑造最終結果表現出濃厚的興趣。但我們的目標和承諾是繼續與政府和國會合作，努力提高我們體系內創新藥物的競爭力和可及性，這也包括B部分。我們認為可以採取一些措施來消除體系中不必要的成本和摩擦，確保需要創新療法的患​​者能夠獲得這些療法，我們將繼續在華盛頓的討論中推進這些想法。但再次強調，這目前只是一個提議，還有足夠的時間來觀察該提議的最終形態。Murdo，你想先回答一下關於產品之間沒有差別這個問題嗎？

Well, yes. As I said in my prepared remarks, the launch of Aimovig has been a fantastic success. We have seen very good provider, payer and patient response to our launch. And as I also mentioned in my prepared remarks, Aimovig is indeed the only receptor antagonist for -- to CGRP. We're also hearing really good feedback on the fact that there is no loading dose and that payer approvals have been quite good so far. So about 70% payer approval rate for a new product in a symptomatic category, and that's a really, really strong signal to us that payers do indeed want to approve and want to pay for these agents. You've seen that we've been able to secure coverage at least with one large PBM with ESI, and we're working through the rest. But I continue to believe that being first-mover in this category and having over 100,000 patients initiated so far, having a really strong program to bridge patients from initiation to secured reimbursement through their insurer and having 12,000 physicians having tried the product to date, puts us in a really strong position to work with payers to make sure that reimbursement for this product is both differentiated and open.

是的。正如我在準備好的演講稿中所說，Aimovig 的推出取得了巨大的成功。我們看到，供應商、支付者和患者對我們的產品推出都給予了非常好的迴響。正如我在準備好的演講稿中提到的，Aimovig 確實是 CGRP 的唯一受體拮抗劑。我們也聽到了很多正面的回饋，例如無需負荷劑量，而且到目前為止，支付方的批准情況也相當不錯。因此，對於用於緩解症狀的新產品，支付方的批准率約為 70%，這對我們來說是一個非常強烈的信號，表明支付方確實想要批准並願意為這些藥物付費。您已經看到，我們至少已經與一家大型藥品福利管理機構 (PBM) 達成了 ESI 的承保協議，我們正在努力與其餘機構達成協議。但我仍然相信，作為該領域的先行者，我們迄今為止已為超過 10 萬名患者提供服務，我們擁有一個非常強大的項目來幫助患者從開始治療到通過保險公司獲得報銷，並且迄今為止已有 12,000 名醫生試用過該產品，這使我們處於非常有利的地位，可以與支付方合作，確保該產品的公開報銷既具有差異化又公開報銷。

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 recognize you don't want to give 2019 guidance until January, but just wondering, David, if you can walk us through maybe the puts and takes for both the top line and margins that we should think about as we look at our models here. And then just high-level expectations for pricing dynamics in 2019, should we expect something similar to what we saw this year?

我知道您不想在 1 月之前給出 2019 年的業績指引，但大衛，我只是想問，您能否為我們講解一下我們在分析模型時應該考慮的營收和利潤率方面的利弊？那麼，對於 2019 年的價格動態，我們是否應該預期會出現與今年類似的情況？

Okay. Thanks, Terence. Yes, so as I said, we'll offer formal guidance in January, but in terms of the contributors to performance next year, I guess I would start by pointing out that -- the company we've got running in a very efficient manner right now, given the work that we've done to improve our competitiveness over the last several years. And we are continuing to challenge ourselves, and we've put in place a continuous improvement program where we're going to get incremental productivity which will help us to fund what is a very exciting pipeline of opportunities that are developing. The second thing I'd mention is that we do continue to increase our investment in support of the new products, most recently Aimovig, most recently also continuing to buildout as was the question around international, which is an investment that we're committed to on an ongoing basis. And then finally, if I look at the revenue side of the business, we're encouraged by the ongoing double-digit growth that we're seeing in our new product portfolio. And of course, we have a fair amount of uncertainty now about, on the legacy side, what is going to be the path of competition and the timing, in particular as it relates to Neulasta and eventually Sensipar. So that's an open question that we'll see, by January, we'll have incremental information on those and we'll be able to share with you our guidance at that time. But overall, we think the business, we've established a nice run rate in terms of profitability and margins, and we'll continue to seek to optimize that while making sure we're not missing any opportunities to invest.

好的。謝謝你，特倫斯。是的，正如我所說，我們將在1月提供正式的業績指引，但就明年業績的貢獻因素而言，我想首先指出的是——鑑於我們在過去幾年中為提高競爭力所做的工作，我們公司目前的營運效率非常高。我們不斷挑戰自我，並製定了持續改進計劃，以提高生產力，從而幫助我們為正在開發的一系列令人興奮的機會提供資金。第二點我想提的是，我們一直在增加對新產品的支援投入，最近推出的就是 Aimovig，最近我們也在繼續拓展國際業務，正如之前提到的，這是我們持續致力於的投資。最後，從業務的營收方面來看，我們的新產品組合持續保持兩位數的成長，這令我們倍感鼓舞。當然，現在我們對傳統藥物方面的競爭路徑和時間安排存在相當大的不確定性，特別是與 Neulasta 和最終的 Sensipar 相關的方面。所以這是一個懸而未決的問題，到一月份，我們會獲得更多相關信息，屆時我們將能夠與您分享我們的指導意見。但總的來說，我們認為公司在獲利能力和利潤率方面已經建立了一個良好的運行速度，我們將繼續尋求優化這一速度，同時確保我們不會錯過任何投資機會。

I think on pricing, Terence, it's premature for us to be offering any comments about 2019 pricing. So I think we're all aware of what the environment is for pricing now globally, and we'll just leave it at that for now.

特倫斯，我認為現在談論 2019 年的定價還為時過早。所以我想我們都清楚目前全球的定價環境，我們就暫時說到這裡吧。

And our next question is from the line of Chris Raymond from Piper Jaffray.

我們的下一個問題來自 Piper Jaffray 的 Chris Raymond。

Maybe another biosimilar question, if I might. Just on the biosimilar eculizumab program, I think you guys still highlight this program pretty prominently on your biosimilar website. But I don't think you've really talked much about this effort in a while, and that I think that's despite having had the go-ahead for just over a year now, I think, from EU regulators to start that trial. So I guess the question is when will we hear more about this program, and maybe when we do, can you maybe tell us in what way?

如果可以的話，我想再問一個關於生物相似藥的問題。就生物相似藥依庫珠單抗計畫而言，我認為你們在生物相似藥網站上仍然非常突出地宣傳了這個計畫。但我認為你已經有一段時間沒有真正談論這項工作了，而且我認為，儘管歐盟監管機構已經批准這項試驗一年多了，但情況依然如此。所以我想問的是，我們什麼時候才能聽到更多關於這個專案的消息？如果聽到消息，您能否告訴我們會以什麼方式公佈？

Why don't we ask Dave to respond to your question, Chris?

克里斯，我們不如請戴夫回答你的問題吧？

Yes, I mean, so as I mentioned, we finished Phase 1 pharmacokinetic and pharmacodynamic study in this program. We have achieved global alignment in terms of the design of the Phase III trial, and we're in startup activities for that study. This, of course, targets a disease where there are limited number of patients. They tend to be focused at centers of expertise. There's competitive patient enrollment. And so we feel that based on where we are, we're well positioned to execute that program.

是的，我的意思是，正如我所提到的，我們已經完成了該計畫的第一階段藥物動力學和藥效學研究。我們在 III 期試驗的設計方面已達成全球共識，目前正在進行這項研究的啟動活動。當然，這針對的是患者數量有限的疾病。它們往往集中在專業領域中心。患者招募競爭激烈。因此，我們認為，根據我們目前所處的位置，我們完全有能力執行該計劃。

And our next question is from the line of Phil Nadeau from Cowen and Company.

我們的下一個問題來自 Cowen and Company 的 Phil Nadeau。

I wanted to ask on Sensipar and the litigation there. You mentioned, a couple of moments ago, you have more incremental information early next year. Can you remind us of the time lines of that litigation and when, in particular, you could finish?

我想問一下關於Sensipar以及相關的訴訟。您剛才提到，明年年初您會有更多後續。您能否提醒我們那場訴訟的時間線，特別是您預計何時能夠結束訴訟？

The litigation's underway now, and we don't have a time line for when the deal's process will be run there. But obviously, this will be visible as part of the normal legal process. And David, you can just reiterate what you said about guidance for the balance of the year, if you'd like, retrospectively.

訴訟正在進行中，我們目前還沒有交易流程何時完成的時間表。但很顯然，這將是正常法律程序的一部分。大衛，如果你願意的話，你可以回顧性地重申你之前對今年剩餘時間的指導意見。

Yes. So what we've indicated is that in the updated 2018 guidance, we have a range which includes, at the top end, where we would continue with Sensipar without generic competition through year-end. And obviously, within the range, we would include other scenarios. But yes, so we're continuing to monitor those, and if there were a launch, it would be at risk at the present time, at least.

是的。因此，我們已經表明，在更新後的 2018 年指導方針中，我們給出了一個範圍，其中最高限度的是我們將繼續銷售 Sensipar，直到年底沒有仿製藥競爭。顯然，在這個範圍內，我們還會包括其他情況。是的，所以我們正在繼續監測這些項目，如果真的發生了發射，至少目前來看，它們會面臨風險。

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。

And I guess another question around -- specifically about your guidance next year and just specifically around Medicare Advantage, given the steps edits that are initially allowed in August and then may go into full effect January 1. Can you help us understand what percentage of Neulasta revenue would be at risk if there was unlimited capacity for a biosimilar of a new asset given the steps edits? And can you help us understand in the scales right now, what you're seeing regarding these plans, forcing people to use a cheaper drug over a brand drug in the distribution of Neulasta and others?

我想再問一個問題——特別是關於您明年的指導意見，特別是關於Medicare Advantage，考慮到8月份最初允許的階梯式調整，然後可能在1月1日全面生效。您能否幫助我們了解，如果考慮到階梯式調整，對新資產的生物相似藥擁有無限的產能，Neulasta的收入將面臨多大的風險？您能否幫助我們了解一下，就目前的情況來看，您認為這些計劃會迫使人們在Neu​​lasta等藥物的分銷過程中使用更便宜的藥物而不是品牌藥？

Okay, Robyn. We are having a little bit of difficulty hearing you at times during your question. So I don't know that we want to give specific percentages in response to your question, but Murdo, go ahead, I invite you to offer any thoughts.

好的，羅賓。我們有時聽不太清楚您提問的內容。所以，我不知道我們是否應該針對你的問題給出具體的百分比，但是默多，請暢所欲言，歡迎你提出任何想法。

Yes, I think the specific question was related to step edits in Medicare Part B and what we think the impact of that would be on Neulasta, particularly in light of biosimilars, if I heard properly. But I would say that we've been pleased so far with how Medicare Part B plans are -- how Medicare Part B has been managed. However, we are clearly aware that on the 340B side of Medicare, there are certain advantages to biosimilars. But on the Part B side of Medicare, the Medicare Advantage step edits have been moderate so far, and we would expect that to be the case in 2019. Beyond that, I think we'll see more propagation, but it's hard to pin down specifically where we'll see it.

是的，我認為具體的問題與 Medicare B 部分的階梯式調整有關，以及我們認為這會對 Neulasta 產生什麼影響，尤其是在生物相似藥方面，如果我沒聽錯的話。但我認為，到目前為止，我們對聯邦醫療保險 B 部分的計劃——聯邦醫療保險 B 部分的管理方式——感到滿意。但是，我們清楚地知道，在 Medicare 的 340B 計劃方面，生物相似藥具有一定的優勢。但就聯邦醫療保險 B 部分而言，聯邦醫療保險優勢計劃的階梯式調整迄今為止還比較溫和，我們預計 2019 年的情況也將如此。除此之外，我認為我們會看到更多傳播，但很難具體確定會在哪裡發生。

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 wanted to ask an R&D question, and that was, obviously, you highlighting a lot more about the BiTE platform. You obviously have some early AMG 420 data you have reported out. I guess maybe if you could speak to how competitive you expect bispecific, either BCMAs or bispecifics overall, are expected to be versus CAR Ts and how you expect yourself to be positioned with bispecifics overall, and maybe with a focus on BCMA just to start off with.

我想問一個研發方面的問題，很顯然，你們重點介紹了 BiTE 平台。顯然，你已經公佈了一些早期 AMG 420 的數據。我想，如果您能談談您認為雙特異性抗體（無論是BCMA還是整體上的雙特異性抗體）與CAR-T抗體相比的競爭力如何，以及您認為自己在雙特異性抗體領域的整體定位，或許可以先重點關注BCMA。

Dave...

戴夫…

Yes, thanks for the question. I'll first start at a high level by saying don't necessarily expect CAR Ts and BiTEs to be mutually exclusive. We think all of these therapies will find a home. We've been quite pleased with the data we've seen so far in our BCMA-directed BiTE programs. We think that they do have some potential advantages. Number one, these are off-the-shelf therapies. Our goal in all of these programs is to deliver an off-the-shelf medicine that an average oncologist can deliver, whether at an academic center or in the community as opposed to a specialized center for CAR Ts. We also expect, of course, to be able to deliver these at a competitive cost of goods, which in the longer-term, I think, will be important. And then, finally, we believe that with the BiTE platform, as I mentioned, and going after multiple targets, it affords us the ability to take multiple shots at a tumor cell by either using them in combination or sequentially, and our goal here really is to produce very deep and durable responses.

是的，謝謝你的提問。首先，我要從宏觀層面說明，不要指望 CAR T 和 BiTE 是互斥的。我們認為所有這些療法都會找到用武之地。我們對目前為止在 BCMA 指導的 BiTE 專案中看到的數據非常滿意。我們認為它們確實具有一些潛在優勢。第一，這些都是現成的療法。我們在所有這些計畫中的目標是提供一種現成的藥物，讓普通腫瘤科醫生無論是在學術中心還是在社區都能使用，而不是在專門的 CAR-T 中心使用。當然，我們也希望能夠以具有競爭力的商品成本提供這些產品，我認為從長遠來看，這將非常重要。最後，正如我所提到的，我們相信借助 BiTE 平台，透過針對多個靶點，我們可以對腫瘤細胞進行多次攻擊，無論是組合使用還是順序使用，而我們的目標確實是產生非常深入和持久的反應。

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

我們的下一個問題來自 Leerink 的 Geoffrey Porges。

A question for you, Bob. Looking at your commentary and all of the results, there are obviously a lot of pressures in different parts of the portfolio but also some opportunities. The first question is, are you running the company with the expectation of growth or with the expectation of stability from the current portfolio? And then, secondly, you've commented in the past that the business development opportunities are being constrained by the price of the available assets, and obviously, that's changing. Could you give us a sense of, from both the Amgen perspective and your sort of industry perspective, on whether assets are becoming more available and attractive and what sort of cadence you would expect things to start to move?

鮑勃，我有個問題想問你。從你的評論和所有結果來看，投資組合的不同部分顯然都面臨著許多壓力，但也存在一些機會。第一個問題是，您經營公司的目的是為了追求成長，還是為了依靠現有業務來保持穩定？其次，您過去曾說過，業務發展機會受到可用資產價格的限制，顯然，這種情況正在改變。能否從安進公司和您所在行業的角度，談談資產是否變得更加可用和有吸引力，以及您預計事情會以怎樣的節奏開始發展？

Sure. Geoff, our orientation is to try to position the company to deliver long-term growth for our shareholders. So our focus is on delivering a portfolio that can generate long-term growth, and that starts with innovation, the ability to demonstrate the value of that innovation and then the ability to capture the benefit of it globally. So that's what we're focused on. And you're right, we've positioned the company to be, we think, in a strong position to deal with the kind of headwinds that the industry is dealing with at the moment. And in addition, we have some of our own individual patent expirations, but we think we're in a good position to manage through those as well. At the same time, as you point out, valuations have been volatile and have started to come down for some of the earlier-stage companies in our sector, and we'll continue to look for opportunities, and I suspect our well-capitalized peers will as well, opportunities to advance innovation where we think we can do that through business development that adds value to our shareholders. So we're paying close attention to it, as you would expect, and we will continue to do that. As with respect to cadence, Geoff, I wouldn't like to comment on whether we'll see an increase in activity or not, but I think it's fair to observe the prices are adjusting in the sector.

當然。傑夫，我們的目標是努力使公司實現長期成長，從而為股東創造價值。因此，我們的重點是打造能夠產生長期成長的產品組合，而這始於創新，在於證明創新的價值，然後在於全球取得創新帶來的效益。所以這就是我們關注的重點。你說得對，我們認為，我們已經讓公司處於一個強大的地位，能夠應對目前產業面臨的各種不利因素。此外，我們本身也有一些專利即將到期，但我們認為我們有能力應對這些問題。同時，正如您所指出的，估值一直波動較大，我們行業中一些早期公司的估值已經開始下降，我們將繼續尋找機會，我懷疑我們資金雄厚的同行也會這樣做，尋找機會，透過業務發展為股東創造價值，從而推進我們認為能夠實現的創新。所以，正如你所料，我們正在密切關注此事，並且我們將繼續這樣做。至於節奏方面，Geoff，我不想評論我們是否會看到活動增加，但我認為可以合理地觀察到該行業的價格正在調整。

And 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 的發言。

Bob, 2 questions for you. First, as the CEO of Amgen and then as the head of PhRMA. First, contextually, if you think about the biosimilar business, your biosimilar business, what kind of -- what percentage of Amgen revenue should biosimilar achieve in, say, 5, 8, 10 years, just pick a horizon of your choosing, just to get a feel of how you're thinking about this. And second, you talked about helping the administration shape their proposal. I guess the basic question is can PhRMA accept or support any proposal where the U.S. will use international benchmark data prices in other countries to set or determine U.S. prices as the principal?

鮑勃，我有兩個問題想問你。首先擔任安進公司首席執行官，然後擔任美國藥品研究與製造商協會主席。首先，從背景上看，如果你考慮一下生物相似藥業務，你自己的生物類似藥業務，生物類似藥在安進公司5年、8年、10年內應該達到多少收入百分比，隨便選一個你認為合適的期限，只是為了感受一下你是如何思考這個問題的。其次，您談到了幫助政府完善提案。我想最基本的問題是，美國藥品研究與製造商協會（PhRMA）能否接受或支持任何以其他國家的國際基準數據價格為主要依據來設定或確定美國價格的提案？

So Ronny, 2 very different questions there. First, with respect to biosimilars, as you know, we're advancing 10 products in aggregate. They address a market of $65 billion-plus of revenue opportunity. We've said that we think this can be an important growth driver for us. We have talked in the past about this being a, potentially, a multibillion dollar business unit for us. We're pleased so far. We've been operating on time and on budget in this area. We have noted that it's proving difficult for some of our competitors, but we expected that, that would be the case. So, so far, we like our hand in biosimilars, and we think that this can be a growth driver for us. But to state the obvious, we have been and we will continue to be driven by our innovative portfolio of products, and that's not going to change as we advance our 10 similar molecules. So while they can contribute to growth, the balance of our business is still going to remain overwhelmingly an innovative-led business. And with respect to your question about the pricing environment in this country, obviously, we think that innovation and having access to it are critical. We think the United States has benefited from innovation, making it to the citizens in this country more rapidly than in other countries. And we think that if you look across diseases, our citizens are benefiting from the availability of new medicines more quickly and more comprehensively than in other countries, and what we're focused on is seeing both that the innovative ecosystem is maintained and that patients can have access to those. As I've said -- or as I said earlier on this call, particularly in an aging society, we think what's required is more innovation, not less and a system that enables people to get access to that innovation swiftly. So that's what we're focused on, and I think you can see that's what our trade association has been focused on as well.

羅尼，這是兩個截然不同的問題。首先，關於生物相似藥，如您所知，我們總共推進了 10 種產品的研發。它們瞄準的是一個價值超過 650 億美元的市場，蘊藏著巨大的收入機會。我們曾表示，我們認為這可以成為我們重要的成長動力。我們過去曾討論過，這可能成為我們一個價值數十億美元的業務部門。到目前為止，我們都很滿意。我們在這個領域的營運一直按時按預算進行。我們注意到，這對我們的一些競爭對手來說很困難，但我們預料到了這種情況。所以，到目前為止，我們對生物相似藥領域很滿意，我們認為這可以成為我們成長的驅動力。但顯而易見的是，我們過去是、現在是、將來也仍將以我們創新的產品組合為驅動力，隨著我們推進 10 種類似分子的研發，這一點也不會改變。因此，儘管它們可以為成長做出貢獻，但我們業務的平衡仍然將主要以創新為主導。至於您提出的關於我國定價環境的問題，顯然，我們認為創新以及獲得創新的機會至關重要。我們認為，美國受惠於創新，創新成果能夠比其他國家更快惠及美國民眾。我們認為，從各種疾病來看，我國公民比其他國家更快、更全面地受益於新藥的供應，而我們關注的重點是，既要維護創新生態系統，又要確保患者能夠獲得這些藥物。正如我之前所說——或者正如我之前在這次電話會議上所說，尤其是在老齡化社會中，我們認為需要的是更多的創新，而不是更少的創新，以及一個能夠讓人們迅速獲得這些創新的系統。所以這就是我們關注的重點，我想你也可以看出，這也是我們產業協會一直關注的重點。

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。

First, on your BCMA, my question is not on the data, but more on just so we understand the design heading into ASH. And specifically, what's the total N in the trial versus the total N at that specific center where the investigator showed those 5 CRs, just so we have a sense for that? And then, secondly, Murdo, I don't want to ask you on the 227 TMB update, but what I do want to ask you is on CGRP. My question is, the slide mentioned, you expect the TRF activity to moderate and normalize, do you think the class is close to peaking? Or will it continue to grow and competitors are getting more sure? I just wanted to understand that better.

首先，關於您的 BCMA，我的問題不是關於數據，而是關於我們如何理解 ASH 的設計。具體來說，試驗中的總樣本量 N 與研究者展示這 5 個完全緩解病例的特定中心的總樣本量 N 相比是多少？這樣我們才能對此有所了解。其次，Murdo，我不想問你關於 227 TMB 更新的問題，但我確實想問你關於 CGRP 的問題。我的問題是，幻燈片中提到，您預計 TRF 活動會趨於緩和並恢復正常，您認為該班級的活動接近高峰了嗎？或者它會繼續成長，而競爭對手則越來越有把握？我只是想更好地理解這一點。

Okay. We'll answer it in 2 parts. Dave?

好的。我們將分兩部分來回答這個問題。戴夫？

Yes. So let me start with BCMA. The design of the trial is a standard first in-human dose escalation. So we would expect later in the year to present data across all of the cohorts, which, of course, are across quite a range of doses. I'll leave it to the investigators who run the trial to present the details of that, including the sample size and sample sizes by cohort.

是的。那麼，就讓我先從BCMA開始。本試驗的設計是標準的首次人體劑量遞增試驗。因此，我們預計在今年稍後公佈所有隊列的數據，當然，這些隊列涵蓋了相當大的劑量範圍。我將把試驗的詳細情況，包括樣本數和各隊列的樣本量，留給負責試驗的研究人員來介紹。

And Umer, thanks for not asking me technical questions but a different kind on this call, but the CGRP market is, we think, significant and we don't think we're moderating to the point of saturating the market. The point I was making was in our current trend, you see the result of some pent-up demand where patients were anticipating the availability of Aimovig. So we saw quite a large bolus of patients coming in to our patient services hub. And those patients are part of our current curve. At some point, you'll see that the pent-up demand will work through, and there will be a slight change in the slope of the uptake curve, but it will still be a very strong launch curve, especially when you compare it to other recent launches in other categories. And then the other comment that I made that I would draw your attention to is just that the spontaneous patient awareness here unaided is between 10% and 15%. And what we've seen since the launch of our DTC campaign is that our website and other digital media traffic has doubled. And so we really think we're scratching the surface of helping migraine -- chronic migraine sufferers with a preventative therapy such as Aimovig. So it's really just a comment on having a bolus of patients working through the early part of our uptake curve, but we think that we'll see continued demand growth.

Umer，謝謝你這次電話會議沒有問我技術問題，而是問了其他方面的問題。我們認為 CGRP 市場非常重要，我們認為我們還沒有達到市場飽和的程度。我的意思是，在我們目前的趨勢中，你可以看到一些被壓抑的需求的結果，患者們一直在期待 Aimovig 的上市。所以我們看到大量患者湧入我們的患者服務中心。這些患者是我們目前曲線的一部分。在某個時候，你會發現被壓抑的需求會被釋放，市場接受度曲線的斜率會略有變化，但仍然會是一條非常強勁的上市曲線，尤其是在與其他類別的近期上市產品進行比較時。還有一點要提請大家注意，那就是這裡無需幫助的自發性患者意識覺醒率在 10% 到 15% 之間。自從我們推出 DTC 行銷活動以來，我們發現我們的網站和其他數位媒體流量翻了一番。因此，我們認為我們只是在幫助偏頭痛——尤其是像 Aimovig 這樣的預防性療法——方面，才剛開始發揮作用。所以，這其實只是在說明，目前有一大批患者正在經歷我們市場接受度曲線的早期階段，但我們認為我們會看到需求持續成長。

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。

I have another commercial Aimovig question for Murdo. That 100,000 patient number is really spectacular. I was hoping you could maybe help us understand how many of those are still on free drug versus how many have been transitioned to a commercial reimbursement? And then sort of following up on the prior question relating to trajectory and moderation. On Slide 24, your chart on uptake there purely suggests sort of exponential uptake with almost 150,000 prescriptions out in October '18. Is that launch trajectory chart for sort of display purposes only? Or could I be reading into that 150k number?

我還有一個關於Aimovig商業用途的問題想問Murdo。10萬患者這個數字真是驚人。希望您能幫我們了解一下，其中有多少人仍在享受免費藥物，又有多少人已經轉為商業報銷？然後，就之前關於軌跡和調節的問題，再做進一步的探討。在第 24 張投影片中，您關於吸收率的圖表純粹表明了一種指數級吸收率，2018 年 10 月開出了近 150,000 張處方。那張發射軌跡圖只是用來展示的嗎？或者，我對這15萬這個數字有過度解讀了？

You sound like I do when I'm talking to my team here, Kennen. But thanks for the question. We're obviously very excited about this launch trajectory. It is indeed significantly better than recent launches, and there are a few things to consider about that. One, the unmet need for chronic migraine sufferers is really high. Two, this is a very interesting and helpful medicine for those chronic sufferers. And three, payers have allowed the reimbursement of Aimovig. So to your question of how much is paid and how much is free is we would anticipate that, over time, a significant portion of our early launch curve will indeed be paid. I think we have really strong patient feedback, both anecdotally and through our services hub. We have really strong physician or headache specialists feedback, and we would expect that the launch trajectory will continue to be one that exceeds other benchmarks from other categories. As for a specific percentage of free versus paid, it's really hard to do, but I will say we're closing the gap on the ratio quite quickly. So our retail uptake, those are patients going straight to paid product, not through our patient services hub, is rising rapidly and is on the same, if not, more steep trajectory than the total.

肯南，你說話的語氣跟我跟我的團隊說話的語氣一模一樣。不過，謝謝你的提問。我們顯然對這次發射軌跡感到非常興奮。它的確比最近推出的產品好得多，關於這一點有幾點需要考慮。第一，慢性偏頭痛患者的未滿足需求非常高。第二，對於慢性病患者來說，這是一種非常有趣且有益的藥物。第三，支付方已允許對 Aimovig 進行報銷。所以對於你提出的「有多少是付費的，有多少是免費的」這個問題，我們預計，隨著時間的推移，我們早期發布曲線的很大一部分確實是付費的。我認為我們獲得了非常積極的患者回饋，無論是透過口耳相傳還是透過我們的服務中心。我們收到了來自醫生或頭痛專家的非常積極的回饋，我們預計該產品的上市軌跡將繼續超越其他類別的基準。至於免費用戶與付費用戶的具體百分比，這真的很難做到，但我可以說，我們正在迅速縮小兩者之間的比例差距。因此，我們的零售購買量（即患者直接購買付費產品，而不是透過我們的患者服務中心）正在迅速成長，且其成長速度與整體成長速度相同，甚至更快。

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。

I wanted to follow up on CGRP and ask about access. So we've seen the one publicly announced incremental formulary one for Aimovig already with Express Scripts. But anecdotally, could you speak to how dynamic these payer discussions in formulary positioning are now that competition's entered the market? Or maybe more specifically, do you see this as being a market that necessitates competitive rebates or discounts to drive access, or should we be thinking about this space differently?

我想跟進 CGRP 的相關事宜，並詢問訪問權限。所以我們已經看到 Express Scripts 為 Aimovig 公開宣布的增量處方集。但就我個人觀察而言，隨著競爭對手進入市場，支付方在藥品目錄定位方面的討論現在有多活躍？或者更具體地說，您是否認為這是一個需要透過競爭性回扣或折扣來促進市場准入的市場，或者我們應該以不同的方式思考這個領域？

Yes, so far, we're feeling quite good about what we've been able to do with payers. As we mentioned, the ESI win. We also have good indications from Anthem and Kaiser. We are working through the process across other plans, and the access team here is out there negotiating. And yes, you will see some gross-to-nets in the form of rebates. Where we end up with that, it's just very early to tell. But we want to make sure that patients have access to Aimovig. You can tell that, that was our strategy from the beginning with the price point that will established in the market. And we will indeed be continuing to ensure that patients have good comprehensive access, both commercially and in Part D.

是的，到目前為止，我們對與付款者合作的成果感到非常滿意。正如我們之前提到的，ESI 獲勝了。我們也從 Anthem 和 Kaiser 那裡得到了很好的信號。我們正在其他計劃中推進這一流程，這裡的准入團隊正在外面進行談判。是的，你會看到一些稅前利潤與稅後利潤的差額，以折扣的形式反映出來。最終結果如何，現在下結論還為時過早。但我們希望確保患者能夠獲得 Aimovig。你可以看出，從一開始，我們的策略就是確定市場上的價格點。我們將繼續確保患者能夠獲得良好的全面醫療服務，包括商業醫療服務和D部分醫療服務。

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

我們的下一個問題來自瑞銀集團的卡特古爾德。

I guess, for David, on the myeloma landscape that -- your myeloma assets, between KYPROLIS, BCMA, your CD38 and MCL-1, I guess is there an underlying perspective on how you either think the myeloma landscape is going to evolve or how you think you can shape it as opposed to just viewing these as sort of disparate assets?

我想，對 David 來說，在多發性骨髓瘤領域——你的多發性骨髓瘤資產，包括 KYPROLIS、BCMA、CD38 和 MCL-1，你是否對多發性骨髓瘤領域的發展趨勢或你認為如何塑造它有一個潛在的見解，而不是僅僅將這些資產視為彼此獨立的資產？

Thank you for the question. It's a great question. Our feeling is that we're actually very well-positioned to have potentially transformative impact on this disease. Our view is that combinations of these agents will be used going forward. And the goal, I think, really now, is cure or functional cure for this disease. Someone trained as an oncologist, that's not a word you use lightly, but I think it's warranted here and we would view this as a collection of agents that we think we can use in the right combinations to really drive towards that kind of outcome as opposed to a series of one-offs.

謝謝你的提問。這是一個很好的問題。我們認為，我們實際上處於非常有利的位置，有可能對這種疾病產生變革性的影響。我們認為，未來將會使用這些試劑的組合。我認為，現在的真正目標是治癒或基本上治癒這種疾病。腫瘤科醫生，這個詞用在這裡並不合適，但我認為在這裡用它是恰當的。我們會把這看作是一系列藥物的集合，我們認為我們可以用正確的組合來真正推動那種結果，而不是一系列一次性的治療。

And our next question is from the line of Alethia Young from Cantor Fitzgerald.

我們的下一個問題來自坎托·菲茨杰拉德的阿萊西亞·楊的詩句。

Tony, congrats on a wonderful run and congrats for everybody else who has been added to the team. I guess I have a question about the PAC1 data coming. Just how do you envision this mechanism fitting with CGRP and generally what your expectations kind of heading into this readout at the end of the year?

東尼，恭喜你取得如此輝煌的成績，也恭喜所有加入團隊的成員。我想問一下關於即將發布的PAC1數據的問題。您認為該機制將如何與 CGRP 相契合？您對年底的數據公佈有何預期？

Sure. Thanks. This is Dave Reese. I'll handle that question. PAC1, the PAC1 receptor sits in a pathway that is very distinct from the CGRP pathway. The sort of neurovascular pathways that we believe are involved in the genesis of migraine are quite different here. Now what we don't have with the PAC1 receptor that we had during CGRP development was a sort of clinical validation because it is a first-in-class, first out-of-the-gate agent. The design of the Phase II trial is really quite similar to the design that we had with Aimovig, and it's designed to give us an efficacy readout as well as, of course, additional safety data. Should we see efficacy, the question will then be is there a distinct population of patients that may respond to PAC1 receptor inhibition as compared to CGRP inhibition. And that would be something that the development program would be intended to determine going forward.

當然。謝謝。這是戴夫·里斯。我會處理這個問題。PAC1，即 PAC1 受體，位於一條與 CGRP 路徑截然不同的路徑中。我們認為與偏頭痛發生有關的神經血管通路在這裡截然不同。現在，PAC1 受體不像 CGRP 開發時那樣，需要進行某種臨床驗證，因為它是一種首創的、率先上市的藥物。二期試驗的設計與我們先前對 Aimovig 的設計非常相似，其目的是為我們提供療效讀數以及額外的安全性數據。如果我們看到療效，那麼接下來的問題就是，與 CGRP 抑制劑相比，是否存在對 PAC1 受體抑制劑有反應的特定患者群體。而這正是未來發展計畫所要確定的問題。

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

我們的下一個問題來自瑞穗證券的 Salim Syed。

And best of luck to Tony. Tony, I'm still happy to send you my Repatha scripts, if you want. And welcome to Murdo. I have one on PCSK9, either for you, Murdo, or for Tony. On inclisiran, so obviously, another quarter has passed and another -- we've got another DSMB update. At what point -- or maybe how do you guys framework this in terms of threat versus being complementary to your PCSK9 maybe for primary prevention or threat regarding pricing or volume? How do you guys framework those 2 things? And maybe just give us your thoughts around that.

祝托尼好運。東尼，如果你需要的話，我仍然很樂意把我的Repatha處方寄給你。歡迎來到默多。我在 PCSK9 上有一張圖，要嘛給你，Murdo，要嘛給 Tony。關於 inclisiran，顯然，又一個季度過去了，我們又迎來了一次 DSMB 更新。在什麼情況下——或者你們如何從威脅的角度來建構這個概念，例如作為 PCSK9 的補充，用於一級預防，或在定價或數量方面作為威脅？你們是如何看待這兩件事的？或許您可以和我們分享您對此的看法。

All right. We might just start the answer to your question, Salim, with Dave Reese since you're asking questions about our clinical program.

好的。薩利姆，既然你問的是關於我們臨床計畫的問題，那我們不妨先從戴夫·里斯開始回答你的問題。

Yes, I mean, I would offer a few observations here. First, long-term safety is an absolutely critical outcome in this class. And with Repatha, we have an enormous amount of data. I think that is the -- that is probably the critical piece. We'll have to look at the efficacy. I think the accumulated data in -- with Repatha strongly support the lower-is-better hypothesis. I think there's just an overwhelming weight of evidence now in support of that and therefore, we feel very comfortable with what we can deliver with Repatha.

是的，我的意思是，我在這裡想提出幾點看法。首先，長期安全性是本課程中絕對至關重要的結果。而透過 Repatha，我們擁有大量資料。我認為那可能是關鍵。我們需要考察一下效果。我認為，使用 Repatha 累積的數據有力地支持了「越低越好」的假設。我認為現在有大量的證據支持這一點，因此，我們對Repatha能夠提供的產品感到非常有信心。

Yes. The only thing I would add, Salim, is as Tony mentioned, I've got decades of experience. And I've been in cardiovasculars now for decades. I've seen the evolution of statins. I've seen the evolution of anti-platelet drugs. I've seen the evolution of novel oral anticoagulants. And I think what I hope to be able to do is pick up where Tony left off and really expand the usage of PCSK9s and in specific Repatha for these high-risk cardiovascular patients where we've proven an event reduction benefit. We can do that with substantial time horizon prior to when we would expect other competition like inclisiran entering the market. And I think with recent moves we've made to improve access, specifically for Part D patients, which is, as you know, that 65% of the potential patient pool, we should be able to help improve the volume growth of Repatha between now and when we might face new competition. Part of me wants to say that new competition can expand the class and improve interest in it, but I would like to make sure that we're competitive when we drive share there as well.

是的。薩利姆，我唯一要補充的是，正如托尼所提到的，我有幾十年的經驗。我從事心血管疾病治療已經幾十年了。我見證了他汀類藥物的發展歷程。我見證了抗血小板藥物的發展歷程。我見證了新型口服抗凝血劑的發展歷程。我希望能夠接過托尼未竟的事業，真正擴大 PCSK9 抑制劑（特別是瑞百安）在這些高風險心血管疾病患者中的應用，我們已經證明瑞百安可以降低心血管事件的發生率。我們可以提前相當長的時間做到這一點，在我們預期像inclisiran這樣的其他競爭對手進入市場之前。我認為，隨著我們最近採取措施改善患者獲取途徑，特別是針對D部分患者（如您所知，他們佔潛在患者群體的65%），我們應該能夠幫助提高Repatha的銷售增長，直到我們可能面臨新的競爭為止。我一方面認為新的競爭可以擴大市場份額，提高人們對這個領域的興趣，但我也想確保我們在市場份額方面也具有競爭力。

And our last question comes from the line of Brian Skorney from Robert W. Baird.

最後一個問題來自羅伯特·W·貝爾德的布萊恩·斯科尼。

I just wanted to get your thoughts. I know you just had a -- completed a trial with Sandoz regarding the Enbrel infringement. I'm just wondering when you expect the drugs to return the decision in this case. And can you just kind of walk us through what the best case and worst case scenarios are for you guys in terms of potential biosimilar impact and the time line of exclusivity?

我只是想聽聽你的想法。我知道你剛結束了與山德士公司關於恩利侵權案的審判。我只是想知道您預計藥物檢測何時能得出結果。能否請您簡要介紹一下，對於你們而言，生物相似藥可能產生的影響以及獨佔期的時間安排，最好的情況和最壞的情況分別是什麼？

Well, Brian, the closing arguments are expected in that trial later this year. I think late in November, we're expecting closing arguments, and then sometime thereafter, likely months thereafter, we'll have the judge's decision. And then I'm sure whichever way the outcome is, you can expect there will be challenges in the appeals process. So at this point, why don't we just simply reiterate that we stand by the intellectual property of Enbrel and we look forward to having an opportunity to validate that intellectual property through this court process. Okay. I think -- let me thank you all for joining us on the call, and I hope you can see from our report in the third quarter that we continue to deliver solid financial performance. We're ready for the change in competitive environment that all of us, I think, in this industry face, focused on developing innovative first-in-class therapies, and we're excited about the 7 that we talked about, just having introduced them in the clinic, doing our part and working with our colleagues in the industry to improve accessibility and affordability for our products, and finally, excited about the level of engagement that we continue to enjoy from our staff around the world. So thank you all for your participation in the call. And as usual, our IR team will be standing by if you have any further questions.

布萊恩，那場審判的結案陳詞預計將於今年稍晚進行。我認為在 11 月下旬，我們會聽到結案陳詞，然後可能在幾個月之後，我們會聽到法官的判決。而且我相信，無論結果如何，上訴過程中都會遇到挑戰。所以，在這一點上，我們不妨重申一下，我們堅持恩利（Enbrel）的智慧財產權，並期待有機會透過這項法庭程序來驗證該智慧財產權。好的。我想——感謝各位參加本次電話會議，希望大家能從我們第三季的報告中看出，我們繼續取得了穩健的財務表現。我們已經準備好迎接競爭環境的變化，我認為我們這個行業的每個人都面臨著這種變化，我們專注於開發創新的一流療法，我們對剛剛在臨床上推出的7種療法感到興奮，我們正在盡自己的一份力量，與業內同行合作，提高我們產品的可及性和可負擔性，最後，我們對世界各地員工持續保持的積極參與度感到興奮。感謝各位參與本次電話會議。如往常一樣，如果您有任何其他問題，我們的投資者關係團隊將隨時為您服務。

Thanks, everybody.

謝謝大家。

Ladies and gentlemen, this does conclude the Amgen's Third Quarter 2018 Earnings Call. We thank you greatly for joining us.

女士們、先生們，安進公司2018年第三季財報電話會議到此結束。非常感謝您的參與。