美國安進 (AMGN) 2019 Q3 法說會逐字稿

(technical difficulty)

（技術難題）

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

我叫伊恩，今天我將擔任安進公司第三季財務業績電話會議的主持人。（操作說明）

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

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

Okay. Thank you, Ian. Good afternoon, everybody. Thanks for joining us today. So we have a lot of ground to cover so I'll keep my comments very brief.

好的。謝謝你，伊恩。大家下午好。感謝您今天收看我們的節目。所以我們有很多內容要講，所以我盡量簡短地發言。

I'd like to begin by acknowledging those who are new in their coverage of our company, with the most recent being Geoff Meacham, who's now with Bank of America Merrill Lynch. I also want to correct an oversight on my part from our Q2 call as I inadvertently forgot to acknowledge Evan Seigerman of Crédit Suisse, who initiated back in the second quarter. A warm welcome to both Evan and Geoff.

首先，我要感謝那些新近開始報道我們公司的媒體，其中最新的一位是 Geoff Meacham，他現在就職於美國銀行美林證券。我還想糾正我在第二季度電話會議上的一個疏忽，我不小心忘記感謝瑞士信貸的 Evan Seigerman，他在第二季度發起了這項業務。熱烈歡迎埃文和傑夫。

Okay. So on to our Q3 results. Continued execution on our strategy, launch progress and pipeline advancement are some key themes that come to mind as I think about our third quarter results.

好的。接下來是我們的第三季業績。在思考我們第三季業績時，我首先想到的是策略的持續執行、產品發布進度和產品線推進等幾個關鍵主題。

To discuss these in some detail, I'm joined today by Bob Bradway, our Chairman and CEO. After Bob's comments, our CFO, Dave Meline, will review our financial results for the third quarter and provide updated guidance for 2019. Our Head of Commercial Operations, Murdo Gordon, will then review our product performance, followed by David Reese, our Head of R&D, who will provide a pipeline update. We'll use slides to guide our discussion today, and a link to those slides was sent separately.

今天，我邀請到了我們的董事長兼執行長鮑勃·布拉德韋，他將與我們詳細討論這些問題。在鮑伯發言之後，我們的財務長戴夫梅林將審查我們第三季的財務業績，並提供 2019 年的最新指引。接下來，我們的商業營運主管默多·戈登將回顧我們的產品表現，隨後，我們的研發主管大衛·里斯將提供產品線更新資訊。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。

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

提醒各位，我們今天的演示將使用非GAAP財務指標，其中一些陳述屬於前瞻性陳述。我們的 10-K 表格和隨後提交給美國證券交易委員會的文件列出了可能導致我們的實際業績與預期業績有重大差異的因素。

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

那麼，接下來我將把電話交給鮑伯。鮑伯？

Okay. Thank you, Arvind, and good afternoon, everyone. I'll begin the call today with some comments about our third quarter performance while also touching on the industry environment and how we're responding to it strategically.

好的。謝謝你，Arvind，大家下午好。今天我將首先就我們第三季的業績發表一些評論，同時也會談到產業環境以及我們如何從策略上應對它。

Several years ago, we realized the need to transform certain aspects of our business to stay ahead of the curve and position ourselves for a sustained long-term growth. Anticipating pressure on drug pricing, for example, we emphasized the importance of innovative medicines that can grow over time through volume and access increases. And that's what we're seeing again in the third quarter from brands like Prolia, Repatha and Aimovig generating double-digit volume increases. It's not just these brands that are exhibiting volume growth. A number of our specialty products, including Parsabiv, KYPROLIS and Blincyto, also registered double-digit volume increases, and in aggregate for our portfolio, this is the seventh quarter in a row that we've reported volume growth globally. We think that bodes well for our long-term outlook.

幾年前，我們意識到需要對業務的某些方面進行變革，以保持領先地位並為持續的長期成長做好準備。例如，考慮到藥品定價可能面臨壓力，我們強調了創新藥物的重要性，這些藥物可以透過增加銷售量和提高可及性而隨著時間的推移而增長。我們在第三季再次看到，像 Prolia、Repatha 和 Aimovig 這樣的品牌實現了兩位數的銷售成長。銷售成長的不僅是這些品牌。我們的一些特色產品，包括 Parsabiv、KYPROLIS 和 Blincyto，銷量也實現了兩位數的成長。總的來說，這是我們連續第七個季度在全球銷售成長。我們認為這預示著我們的長期前景良好。

As you're aware, drug prices have indeed come under pressure. In the U.S. for the first time in more than 40 years, as the Council of Economic Advisers recently reported, CPI prescription drug index actually declined over the previous 12 months by 0.7%. This broad price decrease in 2019 is consistent with our own experience. Against this backdrop, a flow of innovative medicines that address major unmet medical needs will be more important than ever. As Dave Reese will discuss in a moment, we're excited about our pipeline and we're investing to rapidly advance it.

如您所知，藥品價格確實面臨壓力。根據美國經濟顧問委員會最近報告，美國 CPI 處方藥指數在過去 12 個月中實際下降了 0.7%，這是 40 多年來的首次。2019 年的這種大幅度價格下降與我們自身的經驗相符。在此背景下，源源不絕地推出能夠滿足重大未滿足醫療需求的創新藥物將比以往任何時候都更重要。正如戴夫·里斯稍後將要討論的那樣，我們對我們的產品線感到非常興奮，我們正在投資以快速推進其發展。

Thanks to a set of productivity capabilities embedded throughout our organization, we've been able to increase our R&D spending this year, up 8% in the third quarter, while keeping overall expenses flat. We've been especially focused on building differentiated capabilities in Discovery Research. For example, we think recent collaborations with the U.K. Biobank and Intermountain Healthcare will enable us to extend our industry-leading human genetics capabilities. Over time, we expect a better understanding of human genetics will enable us to dramatically improve both R&D cycle times and success rates. And with our Nuevolution deal completed earlier this year, we're positioning Amgen for what we anticipate will be a new era of multi-specific drug development, focusing initially on targeted protein degradation.

由於我們組織內部嵌入的一系列生產力能力，我們今年得以增加研發支出，第三季成長了 8%，同時保持了整體支出不變。我們尤其註重在探索性研究領域中建構差異化能力。例如，我們認為最近與英國生物銀行和Intermountain Healthcare的合作將使我們能夠擴展我們行業領先的人類遺傳學能力。隨著時間的推移，我們期望對人類遺傳學的更深入了解能夠顯著提高研發週期和成功率。隨著我們今年早些時候完成與 Nuevolution 的交易，我們正在為安進公司做好準備，迎接我們預期的多特異性藥物開發新時代，初期重點是靶向蛋白質降解。

We've made a strategic decision several years ago to build a branded biosimilars business, leveraging our world-class Biologics development and manufacturing capabilities. Our first 3 biosimilars, AMGEVITA, KANJINTI and MVASI generated about $173 million in the third quarter and are annualizing at approximately $700 million. We expect our growing portfolio of reliable, high-quality biosimilars to be an important growth opportunity for us in the years ahead.

幾年前，我們做出了一項策略性決策，即利用我們世界一流的生物製劑開發和生產能力，打造品牌生物相似藥業務。我們的前 3 款生物相似藥 AMGEVITA、KANJINTI 和 MVASI 在第三季度創造了約 1.73 億美元的收入，年收入約為 7 億美元。我們預計，我們不斷成長的可靠、高品質的生物相似藥產品組合將在未來幾年為我們帶來重要的成長機會。

The demand for quality health care is growing globally and this has led us to steadily expand our geographic presence. In the third quarter, our product sales outside the U.S. grew by 15% with volume growth of 23%. We expect sales outside the U.S. to account for an increasing percentage of our total product revenues over time. We're excited, for example, to have recently launched Repatha in China, our first product entry into the world's second-largest pharmaceutical market. We expect this to become an important market for us through time just as we can now see Japan emerging as an important new opportunity for us.

全球對優質醫療保健的需求不斷增長，這促使我們穩步擴大業務範圍。第三季度，我們在美國以外的產品銷售額成長了 15%，銷量成長了 23%。我們預計，隨著時間的推移，美國以外的銷售額將占我們產品總收入的比例越來越高。例如，我們很高興最近在中國推出了 Repatha，這是我們首次將產品推向全球第二大藥品市場。我們預計隨著時間的推移，這將成為一個對我們重要的市場，就像我們現在看到日本正在成為我們重要的新機會一樣。

In 2020, we look forward to assuming full ownership of our very successful collaboration with Astellas in Japan, the world's third-largest pharma market. We think our portfolio of product is well suited to the needs of an aging population in China and Japan, particularly.

2020年，我們期待全面接管我們與安斯泰來在日本（世界第三大醫藥市場）非常成功的合作。我們認為，我們的產品組合非常適合中國和日本等老齡化人口的需求。

And finally, let me reiterate that we're excited about our planned acquisition of Otezla, as announced in August. Amgen has been a leader in the treatment of inflammatory diseases for decades. With Enbrel, our recent launch of AMGEVITA in Europe, pipeline opportunities like tezepelumab, Otezla will significantly strengthen our inflammation portfolio. It will also enhance our geographic presence as we're acquiring global rights to the product, which is approved in more than 50 markets worldwide.

最後，我想再次重申，我們對8月宣布的收購Otezla的計畫感到非常興奮。安進公司數十年來一直是發炎性疾病治療的領導者。隨著 Enbrel 的上市，以及我們最近在歐洲推出的 AMGEVITA，還有 tezepelumab、Otezla 等在研產品，我們的發炎產品組合將顯著加強。隨著我們獲得該產品的全球權利（該產品已在全球 50 多個市場獲得批准），這將增強我們的地理影響力。

We expect the Otezla acquisition to close before the end of the fourth quarter, giving us an asset that will add to our long-term growth. Of course, we look forward to welcoming the Otezla team to Amgen.

我們預計 Otezla 的收購將在第四季末之前完成，這將使我們獲得一項有助於我們長期成長的資產。當然，我們期待 Otezla 團隊加入安進。

Our capital allocation priorities remain intact. We'll continue to invest in the growth of our business internally and through business development aligned with our stated strategy while also providing attractive returns to our shareholders through our growing dividend and continued share repurchases.

我們的資本配置優先事項保持不變。我們將繼續投資內部業務成長，並透過符合我們既定策略的業務發展，同時透過不斷增長的股息和持續的股票回購，為股東提供可觀的回報。

Before I turn the call over to David, let me just note that I'll say a few words about him and his planned retirement at the end of our call. David, over to you.

在把電話轉給大衛之前，我想先說明一下，在通話結束時，我會簡單談談他以及他計劃的退休事宜。大衛，該你了。

Okay. Thanks, Bob.

好的。謝謝你，鮑伯。

Overall, we're pleased with the strong performance in the third quarter as investments in support of our newer products continued to deliver volume-driven growth, including over 20% in our ex U.S. markets, enabling stable performance again this quarter.

總體而言，我們對第三季度的強勁業績感到滿意，因為對新產品的投資繼續帶來銷量驅動的增長，其中在美國以外的市場增長超過 20%，使得本季度再次取得穩定的業績。

Turning to the financial results on Page 6 of the slide deck. Worldwide revenues at $5.7 billion declined 3% year-over-year. Worldwide product sales at $5.5 billion declined 1% year-over-year as growth for our newer products was slightly outpaced by declines in our mature brands impacted by increasing competition due to patent expirations. Other revenues declined $120 million year-over-year due to a prior year milestone payment. We expect full year other revenues of between $1.1 billion and $1.2 billion.

接下來請看投影片第6頁的財務表現。全球營收為 57 億美元，年減 3%。由於專利到期導致競爭加劇，成熟品牌的銷售額下降，導致新產品的成長略微超過了成熟品牌的銷售額，全球產品銷售額為 55 億美元，年減 1%。由於上一年的里程碑付款，其他收入比去年同期減少了 1.2 億美元。我們預計全年其他收入將在 11 億美元至 12 億美元之間。

Non-GAAP operating income of $2.8 billion declined 6% from prior year. Non-GAAP operating margin was 51% for the third quarter as we continue to make incremental investments in our products and pipeline to drive growth and maximize shareholder value.

非GAAP營業收入為28億美元，較上年下降6%。第三季非GAAP營業利潤率為51%，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。

Consistent with prior guidance, third quarter non-GAAP operating expenses were flat year-over-year. We expect full year 2019 operating expenses on an absolute basis to be up slightly versus 2018. As a reminder, we expect to see a 15% increase in non-GAAP operating expenses in Q4 versus Q3, reflecting the typical pattern for the business.

與先前的預期一致，第三季非GAAP營運費用與去年同期持平。我們預計 2019 年全年營運支出絕對值將比 2018 年略有成長。再次提醒，我們預計第四季非GAAP營運費用將比第三季成長15%，這反映了該業務的典型模式。

On a non-GAAP basis, cost of sales as a percent of product sales was flat year-over-year at 13.9%. We continue to anticipate 2019 full year cost of sales on an absolute basis to be slightly up based on volume growth, reflecting our industry-leading manufacturing capability. As you begin to model 2020 financials, note that we expect cost of sales as a percent of product sales to be generally consistent with 2019.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比與去年持平，為13.9%。我們繼續預計，由於銷售成長，2019 年全年銷售成本絕對值將略有上升，這反映了我們領先業界的製造能力。在開始模擬 2020 年財務狀況時，請注意，我們預期銷售成本佔產品銷售額的百分比將與 2019 年基本一致。

Third quarter research and development expenses of $977 million were 8% higher year-over-year due to increased investments in support of our early- and late-stage oncology programs. Research and development expenses as a percent of product sales was 17.9%.

第三季研發支出為 9.77 億美元，年增 8%，這主要得益於對早期和晚期腫瘤學計畫的投資增加。研發費用佔產品銷售額的17.9%。

For the full year 2019, we continue to expect the R&D spend trajectory on an absolute basis to increase by a high single-digit percentage as our pipeline advances. As communicated in our August call, we highlighted that we expect 2020 R&D investment to increase by about $500 million as we invest in our innovative pipeline programs and new Otezla indications.

預計 2019 年全年，隨著產品線的推進，研發支出絕對值將以較高的個位數百分比成長。正如我們在 8 月的電話會議中所述，我們強調，隨著我們對創新產品線專案和 Otezla 新適應症的投資，我們預計 2020 年的研發投資將增加約 5 億美元。

SG&A expenses decreased 5% on a year-over-year basis in Q3, driven primarily by reduced general and administrative expenses and productivity efforts. We expect that for the full year, SG&A expense on an absolute basis will decline year-over-year.

第三季銷售、一般及行政費用較去年同期下降 5%，主要得益於一般及行政費用的減少和生產力提升。我們預計全年銷售、管理及行政費用絕對值將年減。

With regard to 2020, in addition to the $600 million to $700 million increase related to the Otezla acquisition, we also expect SG&A expense for the base business to increase modestly year-over-year as we continue to expand our international business, including China and Japan, grow our biosimilar business and begin product launch preparation for advancing innovative oncology and non-oncology pipelines. These investments will exceed the benefits of our 2020 productivity initiatives.

就 2020 年而言，除了與收購 Otezla 相關的 6 億至 7 億美元的增長外，我們還預計，隨著我們繼續擴大國際業務（包括中國和日本）、發展生物類似藥業務以及開始為推進創新腫瘤和非腫瘤產品線的產品上市做準備，基礎業務的銷售、管理及行政費用將同比小幅增長。這些投資帶來的效益將超過我們 2020 年生產力提升計畫的效益。

Other income and expenses were a net $199 million expense in Q3. This is favorable by $23 million on a year-over-year basis. We expect full year 2019 expense of about $675 million.

第三季其他收入和支出淨額為 1.99 億美元。與上年同期相比，這節省了 2,300 萬美元。我們預計 2019 年全年支出約為 6.75 億美元。

Looking ahead to 2020, we expect OI&E net expense to increase reflecting a cash drawdown for the Otezla acquisition.

展望 2020 年，我們預計 OI&E 淨支出將增加，這反映了收購 Otezla 的現金支出。

The non-GAAP tax rate was 15.2% for the quarter, a 2.2 point increase versus the third quarter of 2018 primarily due to a prior year tax benefit associated with intercompany sales under U.S. corporate tax reform. Non-GAAP net income decreased 8%, and non-GAAP earnings per share decreased 1% year-over-year for the third quarter to $3.66 per share.

本季非GAAP稅率為15.2%，比2018年第三季增加2.2個百分點，主要原因是由於美國企業稅制改革下與公司間銷售相關的上一年稅收優惠。第三季非GAAP淨利下降8%，非GAAP每股盈餘較去年同期下降1%至每股3.66美元。

Turning next to cash flow and the balance sheet on Page 7. Free cash flow for the third quarter of 2019 was $3.2 billion. This was in line with the results from the third quarter last year of $3.1 billion.

接下來請看第 7 頁的現金流量表和資產負債表。 2019 年第三季的自由現金流為 32 億美元。這與去年第三季 31 億美元的業績相符。

Consistent with our principles, we continue to provide significant cash returns to shareholders. In Q3, we deployed $1.2 billion to repurchase 6.2 million shares at an average price of $188 per share. We plan to repurchase an incremental $1 billion to $1.5 billion of our shares in Q4. Additionally, our third quarter dividend was $1.45 per share, an increase of 10% over last year.

秉承我們的原則，我們將繼續為股東提供豐厚的現金回報。第三季度，我們投入 12 億美元以每股 188 美元的平均價格回購了 620 萬股股票。我們計劃在第四季額外回購價值 10 億美元至 15 億美元的股票。此外，我們第三季的股息為每股 1.45 美元，比去年增長了 10%。

Cash and investments totaled $20.9 billion, a decrease of approximately $9 billion from the third quarter of last year primarily due to share repurchases and debt repayments. Our debt balance stands at $29.8 billion as of September 30, a reduction of $4.6 billion from a year ago as we paid down maturing debt.

現金及投資總額為 209 億美元，較去年第三季減少約 90 億美元，主因是股票回購和債務償還。截至9月30日，我們的債務餘額為298億美元，比一年前減少了46億美元，因為我們償還了到期債務。

Turning to the outlook for the business for 2019 on Page 8. We remain on track with our plans to deliver solid results while investing for the future. With regard to our updated outlook for 2019 revenue, we're increasing our revenue guidance to $22.8 billion to $23 billion from our prior range of $22.4 billion to $24.9 billion. This reflects solid revenue performance as well as ongoing competitive dynamics associated with Neulasta and other legacy products. We're also increasing our 2019 non-GAAP earnings per share guidance to $14.20 to $14.45 per share from the previous $13.75 to $14.30. In terms of the non-GAAP tax rate, our 2019 guidance range of 14% to 15% is unchanged. We expect capital expenditures of approximately $650 million this year. Note that our guidance excludes the impact of the Otezla acquisition, which we expect to close by year-end.

關於2019年的業務展望，請參閱第8頁。我們將繼續按計劃推進，在為未來投資的同時，取得穩健的績效。關於我們更新後的 2019 年營收預期，我們將營收預期從先前的 224 億美元至 249 億美元上調至 228 億美元至 230 億美元。這反映了穩健的收入表現，以及與 Neulasta 和其他傳統產品相關的持續競爭動態。我們同時將 2019 年非 GAAP 每股盈餘預期從先前的 13.75 美元至 14.30 美元上調至 14.20 美元至 14.45 美元。就非GAAP稅率而言，我們2019年的指引範圍14%至15%維持不變。我們預計今年的資本支出約為 6.5 億美元。請注意，我們的預測不包括 Otezla 收購案的影響，我們預計該收購案將在年底前完成。

As we approach the end of 2019, we're pleased with our progress again this year. As is customary, we will provide full 2020 guidance on our January call.

2019 年即將結束，我們對今年的進展感到滿意。按照慣例，我們將在1月的電話會議上提供完整的2020年業績指引。

This concludes the financial update. I now I'll 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. Good afternoon, everyone.

謝謝你，大衛。大家下午好。

Find product sales information starting on Slide 10.

從第 10 張投影片開始尋找產品銷售資訊。

In the third quarter, volumes grew by 3% year-over-year, which represents, as Bob mentioned, the seventh consecutive quarter of volume growth. Net selling prices declined 4% year-over-year, resulting in reported net sales declining by 1%. We have a stable outlook for our base business in 2020, and with the anticipated addition of Otezla, we expect revenue growth next year.

第三季銷量年增 3%，正如鮑伯所說，這是銷量連續第七個季度實現成長。淨售價年減 4%，導致報告淨銷售額下降 1%。我們對 2020 年的基礎業務前景持穩定態度，隨著 Otezla 的預期加入，我們預計明年營收將實現成長。

Now let me share some product details starting with Prolia on Slide 12. Prolia delivered another strong quarter with 18% growth year-over-year driven by volume coming from increasing rates of new patient growth as well as strong repeat rates. Recall that Prolia experiences consistent seasonal trends.

現在讓我從第 12 張投影片開始，分享一些產品詳情，首先是 Prolia。Prolia 又迎來了一個強勁的季度，年增 18%，這主要得益於新患者成長率的提高以及強勁的複診率帶來的業務量成長。請注意，Prolia 具有穩定的季節性趨勢。

The launch of EVENITY, which has been recognized by the osteoporosis community as a highly innovative therapy, is off to a solid start as sales more than doubled sequentially.

EVENITY 的上市取得了良好的開端，其銷售額環比增長超過一倍，骨質疏鬆症界普遍認為 EVENITY 是一種極具創新性的療法。

Worldwide, 8.9 million fractures due to osteoporosis occur each year. That's a fracture every 3 seconds. In the U.S., there are approximately 2 million patients who have had an osteoporosis-related fracture and are at greatest risk of having another fracture within the next 1 to 2 years. We believe EVENITY is an important option to offer these patients.

全球每年因骨質疏鬆症引起的骨折病例達 890 萬例。平均每3秒鐘就會發生一起骨折。在美國，大約有 200 萬名患者曾發生過與骨質疏鬆症相關的骨折，並且在未來 1 到 2 年內再次發生骨折的風險很高。我們認為 EVENITY 是為這些患者提供的重要選擇。

Within the U.S., we've received a permanent reimbursement J-code, which should facilitate uptake. In Japan, which currently represents the majority of EVENITY sales, uptake has been very encouraging. EVENITY creates a solid foundation in Japan upon which we anticipate adding Otezla, and that will give us an ability to deliver on our international expansion strategy.

在美國，我們已經獲得了永久性報銷 J 代碼，這應該有助於推廣應用。目前 EVENITY 的銷售額主要來自日本，在日本市場的銷售情況非常令人鼓舞。EVENITY 在日本奠定了堅實的基礎，我們預計在此基礎上收購 Otezla，這將使我們能夠實現我們的國際擴張策略。

Next on to Repatha on Slide 14. Q3 sales grew by 40% year-over-year as we continue to be the market leader of the PCSK9 Class. Worldwide unit growth was 87% year-over-year driven by the U.S. New-to-brand U.S. prescriptions are steadily improving, growing at 58% year-over-year.

接下來是第 14 張投影片上的 Repatha。第三季銷售額年增 40%，我們持續維持 PCSK9 類藥物市場的領先地位。全球銷量較去年同期成長 87%，主要得益於美國市場的成長。美國新藥處方量穩定提升，年增 58%。

Although we're pleased with the growing use of Repatha in helping to lower LDL cholesterol, the fact still remains that cardiovascular disease is much too common in our society today. Every year, 30 million people globally will suffer a heart attack or a stroke. Approximately 7 out of 10 adults in the U.S. with cardiovascular disease have elevated LDL-C despite optimal lipid-lowering treatment.

儘管我們很高興看到 Repatha 在幫助降低 LDL 膽固醇方面得到越來越廣泛的應用，但心血管疾病在當今社會仍然非常普遍這一事實仍然存在。全球每年有3000萬人會遭受心臟病或中風。在美國，約有十分之七患有心血管疾病的成年人，儘管接受了最佳的降血脂治療，但其低密度脂蛋白膽固醇（LDL-C）水平仍然升高。

The importance of lowering LDL-C levels as a means to lower the risk of cardiovascular event in high-risk adults is increasingly recognized by professional cardiology societies, including the American Heart Association, the American College of Cardiology, and most recently, the European Society of Cardiology, which now recommends LDL-C levels of less than 55 milligrams per deciliter in high-risk patients and less than 40 milligrams per deciliter in patients with 2 prior cardiovascular events. PCSK9 inhibitors like Repatha can play a critical role in helping patients achieve their cholesterol-lowering objective.

降低 LDL-C 水平對於降低高風險成年人發生心血管事件的風險至關重要，這一點已日益受到專業心臟病學會的認可，包括美國心臟協會、美國心臟病學會，以及最近的歐洲心臟病學會。歐洲心臟學會現在建議，高風險患者的 LDL-C 水平應低於每分升 55 毫克，而有 2 次既往心血管事件史的患者的 LDL-C 水平應低於每分升 40 毫克。PCSK9 抑制劑（如 Repatha）在幫助患者實現降低膽固醇的目標方面可以發揮關鍵作用。

Removing barriers for PCSK9 use is an important factor in ensuring this health crisis is effectively addressed. In the U.S., we're pleased that access is improving. A 72% of commercial plans now require physician attestation only, and that's up from just 23% last year. Additionally, more plans are removing specialty pharmacy mandates, moving Repatha to more accessible retail pharmacies which now fill a majority of Repatha prescriptions.

消除 PCSK9 使用的障礙是確保有效應對這場健康危機的重要因素。在美國，我們很高興看到醫療資源取得正在改善。目前，72%的商業保險計劃僅要求醫生證明，而去年這一比例僅為23%。此外，越來越多的保險計劃取消了專科藥房的強制要求，將 Repatha 轉移到更容易獲得的零售藥房，這些藥房現在負責配發大部分 Repatha 處方。

Overall in the U.S., commercial approval rates increased from 39% to 59% and the abandonment rate for Medicare patients has improved meaningfully.

總體而言，在美國，商業審批率從 39% 提高到 59%，Medicare 患者的放棄率也得到了顯著改善。

Affordability is a concern for Medicare patients, and in 2020, approximately half of all Medicare patients who are prescribed Repatha will have an affordable co-pay of less than $50. Although the blended net price of Repatha in the U.S. declined in Q3 2019 versus the previous year, partly due to contracting for better access and partly with the advent of the lower-list-price Repatha, net selling price was relatively stable sequentially. With lower-list-price Repatha now representing over 50% of total prescriptions, the original list price SKU will no longer be available for sale effective December 31, 2019.

對於聯邦醫療保險患者來說，價格負擔能力是一個令人擔憂的問題。 2020 年，大約有一半被處方 Repatha 的聯邦醫療保險患者的自付費用低於 50 美元。儘管 2019 年第三季度美國 Repatha 的綜合淨價較上年同期有所下降，部分原因是簽訂了更好的准入合同，部分原因是由於定價較低的 Repatha 上市，但淨售價環比相對穩定。由於低價版 Repatha 目前佔處方總量的 50% 以上，原價版 SKU 將自 2019 年 12 月 31 日起停止銷售。

Now on to Aimovig on Slide 15. On a quarter-over-quarter basis, unit volume grew 12%, although reported net sales declined by 20% primarily due to $19 million of unfavorable changes in accounting estimates for sales discounts in prior periods. These adjustments result from a higher proportion of our paid business coming from the lower-priced Medicaid population than initially anticipated.

接下來請看第15張投影片，內容是Aimovig。與上一季相比，銷量增長了 12%，但報告的淨銷售額下降了 20%，這主要是由於前期銷售折扣的會計估計發生了 1900 萬美元的不利變化。這些調整是由於我們付費業務中來自價格較低的醫療補助人口的比例高於預期。

As a reminder, we reported $20 million of favorable changes in accounting estimates in Q4 of 2018, demonstrating the impact on net price of early variability and source of business.

提醒一下，我們在 2018 年第四季報告了 2000 萬美元的會計估計有利變化，這表明早期變動和業務來源對淨價的影響。

Considering there are 4 million migraine patients in the U.S. who are eligible for CGRP treatment, Aimovig has significant potential remaining to penetrate this market. Each week, approximately 7,000 patient starts a CGRP therapy, and to date, more than 260,000 patients have been prescribed Aimovig. Additionally, the number of prescribers is consistently increasing as more than 30,000 physicians have now prescribed Aimovig since launch, including 10,000 primary care prescribers.

考慮到美國有 400 萬名偏頭痛患者符合 CGRP 治療條件，Aimovig 仍有很大的潛力打入這個市場。每週約有 7,000 名患者開始接受 CGRP 治療，迄今為止，已有超過 26 萬名患者被處方了 Aimovig。此外，開立 Aimovig 處方的醫生數量也持續增加，自上市以來已有超過 30,000 名醫生開立了 Aimovig 處方，其中包括 10,000 名初級保健醫生。

Aimovig is the market leader with 50% of total prescriptions exiting Q3.

Aimovig 是市場領導者，在第三季末佔據了處方總量的 50%。

Regarding pricing, we're pleased to see the transition of patients from our free drug program to paid demand is progressing nicely, increasing from 74% in Q2 to 81% at the end of Q3. Additionally, our recent agreement with CVS Caremark rounds out our strong access position going into 2020.

關於定價方面，我們很高興地看到，患者從免費藥物計劃過渡到付費需求的進展良好，從第二季度的 74% 增加到第三季末的 81%。此外，我們最近與 CVS Caremark 達成的協議進一步鞏固了我們在 2020 年的強大市場准入地位。

Moving to our hematology and oncology business. The portfolio of 6 brands collectively totaled $1.2 billion in the quarter, growing again by double digits at 12% on a year-over-year basis. As for some of the larger brands within this portfolio, XGEVA grew 10% in Q3 year-over-year driven by volume. As a reminder, the NCCN guidelines recognize XGEVA with preferred status over zoledronic acid in castration-resistant prostate cancer, reinforcing XGEVA's superiority in this indication.

接下來轉到我們的血液腫瘤業務。該季度旗下 6 個品牌的總銷售額為 12 億美元，年增 12%，再次實現兩位數成長。至於該投資組合中一些較大的品牌，XGEVA 在第三季年增 10%，這主要得益於銷售量的成長。需要提醒的是，NCCN 指南認可 XGEVA 在去勢抵抗性前列腺癌治療中優於唑來膦酸，進一步鞏固了 XGEVA 在該適應症中的優越性。

KYPROLIS grew 15% year-on-year driven primarily by 12% volume growth with the breadth of prescribers continuing to increase. We continue to invest behind KYPROLIS and add to the growing body of clinical evidence demonstrating KYPROLIS' important role in the treatment of multiple myeloma, as the recent results of the CANDOR study indicate. And you'll hear more on this from Dave Reese.

KYPROLIS 年成長 15%，主要得益於銷售量成長 12%，處方醫生的範圍也不斷擴大。我們將繼續增加對 KYPROLIS 的投入，並不斷增加臨床證據，以證明 KYPROLIS 在多發性骨髓瘤治療中的重要作用，正如 CANDOR 研究的最新結果所表明的那樣。戴夫·里斯會就此發表更多評論。

Moving on to Enbrel. Sales increased 6% year-over-year driven by increases in net selling price and changes in accounting estimates, offset by unit volume declines of 2% due to continued competition. Q3 results included a benefit of approximately $60 million in changes in accounting estimates related to sales discounts.

接下來是恩利。受淨售價上漲和會計估計變化的影響，銷售額年增 6%，但由於持續的競爭導致銷量下降 2%，抵消了這一增長。第三季業績包括與銷售折扣相關的會計估計變更帶來的約 6,000 萬美元收益。

We're making investments in Enbrel, including the ENBREL Mini with AutoTouch device, a multi-use product which continues to receive positive feedback from rheumatoid arthritis patients.

我們正在對 Enbrel 進行投資，包括配備 AutoTouch 裝置的 ENBREL Mini，這是一款多用途產品，持續獲得類風濕性關節炎患者的正面回饋。

Overall, we expect volume trends to continue while we anticipate a modest benefit from net selling price on a full year basis in 2019.

整體而言，我們預期銷售趨勢將持續保持，同時預期 2019 年全年淨售價將帶來適度的收益。

We're investing substantially behind our inflammation portfolio which has been strengthened by the reaffirmation of Enbrel's intellectual property; our pending addition of Otezla; our biosimilars of AMGEVITA and ABP 710, which is our biosimilar to REMICADE; the potential of tezepelumab for asthma as well as a number of other assets that are earlier in the R&D pipeline.

我們正在大力投資發炎產品組合，這得益於 Enbrel 智慧財產權的重新確認；我們即將推出的 Otezla；我們的 AMGEVITA 和 ABP 710 生物相似藥（ABP 710 是 REMICADE 的生物類似藥）；tezepelumab 在氣喘治療方面的潛力，以及許多其他處於研發早期階段的資產。

Now on to some of our more mature brands on Slide 20. In Q3, Neulasta sales declined 32% year-over-year with a 31% decline in the U.S. Exit share of Neulasta in the U.S. was comparable to Q2, just under 80% in the long-acting segment, with Onpro unit volume declining slightly on a sequential basis. We're encouraged by how well Onpro has performed so far, demonstrating the confidence that our customers have in the reliability and quality of our supply, along with our broader commercial services.

接下來，請看第 20 張投影片，了解我們一些比較成熟的品牌。第三季度，Neulasta 的銷售額年減 32%，其中美國市場下降 31%。 Neulasta 在美國市場的佔有率與第二季基本持平，在長效製劑領域略低於 80%，而 Onpro 的銷售則較上季略有下降。Onpro 目前為止的良好表現令我們倍感鼓舞，這表明我們的客戶對我們供貨的可靠性和品質以及我們更廣泛的商業服務充滿信心。

We anticipate that additional competitors could launch in the U.S. sometime in the future, but the timing is uncertain, reflecting the complexity of developing and manufacturing molecules in the space.

我們預計未來某個時候可能會有更多競爭對手在美國推出產品，但具體時間尚不確定，這反映了該領域分子研發和生產的複雜性。

Looking forward, recall that Q4 of 2018 benefited from a $55 million BARDA order that we do not anticipate repeating this quarter.

展望未來，回想一下，2018 年第四季受益於 BARDA 的 5,500 萬美元訂單，我們預計本季不會再有這樣的訂單。

Finally, outside of the U.S., Neulasta declined 40% due to increasing competition.

最後，由於競爭加劇，Neulasta 在美國以外的市佔率下降了 40%。

Switching to nephrology, starting on Slide 21. Q3 EPOGEN sales declined 15% due to lower net selling price, which is a function of our contractual pricing commitments with DaVita.

接下來轉到腎臟病學部分，從第 21 張投影片開始。第三季 EPOGEN 銷售額下降 15%，原因是淨售價降低，這與我們和 DaVita 簽訂的合約定價承諾有關。

Meanwhile, Aranesp declined 5% year-over-year in Q3 driven by lower volume due to increased competition. We expect Aranesp sales to continue to decline at a faster rate with both long-acting and short-acting competition in the U.S.

同時，受競爭加劇導致銷售下降的影響，Aranesp 第三季年減 5%。我們預計，由於美國市場上長效和短效止痛藥的競爭，Aranesp 的銷售將繼續加速下降。

Turning to Sensipar on Slide 23. As a result of some at-risk generic launches, year-over-year sales declined 73% to $109 million for the quarter. Given the ongoing legal proceedings, there remains uncertainty about the magnitude of future U.S. Sensipar sales.

請參閱第 23 張投影片中的 Sensipar。由於一些高風險仿製藥的上市，該季度銷售額年減 73% 至 1.09 億美元。鑑於目前的法律訴訟仍在進行中，Sensipar 在美國的未來銷售規模仍有不確定性。

Parsabiv grew by 54% in the third quarter. As a reminder, independent and midsized dialysis providers already utilize Parsabiv for a majority of their calcimimetic patients, while FMC and DaVita are slowly increasing adoption. On a quarter-over-quarter basis, trends were impacted by purchasing patterns, which included a larger purchase in Q2.

Parsabiv 第三季成長了 54%。需要提醒的是，獨立和中型透析服務提供者已經為大多數擬鈣劑患者使用 Parsabiv，而 FMC 和 DaVita 正在逐步增加其使用率。從季度環比來看，趨勢受到購買模式的影響，其中包括第二季更大的購買量。

Our biosimilars recorded sales of $173 million in Q3 and are noted on Slide 25. Our biosimilar strategy continues to come to fruition with 2 successful launches in Europe and 2 recent launches in the U.S.

我們的生物相似藥在第三季實現了 1.73 億美元的銷售額，詳情請見投影片 25。我們的生物相似藥策略持續取得成效，在歐洲成功推出了 2 款產品，最近在美國推出了 2 款產品。

Our global sales are already annualizing at approximately $700 million with adoption of KANJINTI and MVASI in the U.S. and continued growth of KANJINTI and AMGEVITA outside the U.S. The uptake is a result of customers recognizing the quality and importance of Amgen's supply chain as well as our commercial capabilities and services.

隨著 KANJINTI 和 MVASI 在美國的普及以及 KANJINTI 和 AMGEVITA 在美國以外的持續成長，我們的全球年銷售額已達到約 7 億美元。這一增長得益於客戶對安進供應鏈的品質和重要性以及我們的商業能力和服務的認可。

Our experience in commercializing innovative products, along with our established presence in existing commercial resources in these therapeutic areas provides us with a productive operating model. These factors help to reduce costs to the health care system while also generating a return for shareholders.

我們在創新產品商業化方面的經驗，以及我們在這些治療領域現有商業資源的穩固地位，為我們提供了高效的營運模式。這些因素有助於降低醫療保健系統的成本，同時也能為股東創造回報。

When looking at factors for success in the U.S. in terms of access, we have attained coverage in the majority of national commercial accounts and are making good progress in Medicare accounts. As of Q4, we've received reimbursement codes for both KANJINTI and MVASI and believe this will be a catalyst for further uptake. When looking at prescribers, we're seen very encouraging adoption rates in the clinic segment, while non-340B hospitals adoption is showing signs of acceleration.

從美國市場准入角度來看，我們已經獲得了大多數全國性商業保險的覆蓋，並且在醫療保險方面也取得了良好進展。截至第四季度，我們已經收到了 KANJINTI 和 MVASI 的報銷代碼，相信這將成為進一步推廣的催化劑。從處方醫生的角度來看，診所領域的採用率非常令人鼓舞，而非 340B 醫院的採用率也顯示出加速成長的跡象。

Outside the U.S., we continue to see important differences between products and markets in terms of uptake in price erosion. Some markets are experiencing strong uptake at more discounted pricing levels, while other larger markets, including Germany and France, exhibit a more balanced and sustainable opportunity. Here again, we're able to leverage our expertise and footprint in oncology while AMGEVITA will benefit from and synergize nicely with the addition of Otezla.

在美國以外，我們仍然看到產品和市場在價格侵蝕方面的接受度有重要差異。有些市場在折扣價水準下出現了強勁的銷售勢頭，而其他一些規模較大的市場，包括德國和法國，則展現出更平衡和可持續的機會。同樣，我們能夠利用我們在腫瘤學領域的專業知識和影響力，而 AMGEVITA 也將受益於 Otezla 的加入，並與之產生良好的協同效應。

In summary, we plan to continue to drive volume uptake of our more recently launched products while defending our mature brands to deliver better outcomes for patients and the health care system.

總而言之，我們計劃繼續推動近期推出的產品銷售成長，同時捍衛我們成熟的品牌，為患者和醫療保健系統帶來更好的結果。

Now let me turn over to Dave Reese.

現在讓我把麥克風交給戴夫·里斯。

Thanks, Murdo. Good afternoon, everyone.

謝謝你，默多。大家下午好。

As we've previously discussed, our key strategic priorities in R&D include increasing our success rates, improving our speed to market and ensuring access and use for our innovative products. A core component of this strategy is to the use of human genetics and allied genomic and proteomic technologies.

正如我們之前討論過的，我們在研發方面的關鍵策略重點包括提高成功率、加快產品上市速度以及確保我們的創新產品能夠被市場接受和使用。該策略的核心組成部分是利用人類遺傳學以及相關的基因組學和蛋白​​質組學技術。

Following on our collaboration with Intermountain Health disclosed last quarter, we're pleased to announce that we joined a public-private consortium to complete the whole genome sequencing of nearly 0.5 million individuals in the U.K. Biobank. DeCODE, with the Wellcome Sanger Institute, will perform sequencing to rapidly generate data in this most ambitious whole genome project to date. We believe in the power of human genetics to transform medicine, have built an industry-leading platform and anticipate well over 2 million participants in our databases at the conclusion of these projects.

繼上個季度披露的與 Intermountain Health 的合作之後，我們很高興地宣布，我們加入了一個公私合作聯盟，完成了英國生物銀行近 50 萬人的全基因組測序。DeCODE 將與 Wellcome Sanger 研究所合作，進行測序，以快速產生數據，這是迄今為止最雄心勃勃的全基因組計畫。我們相信人類遺傳學能夠改變醫學，我們已建立了一個領先業界的平台，並預計在這些計畫結束後，我們的資料庫中將有超過 200 萬名參與者。

In inflammation, our collaboration with AstraZeneca on tezepelumab continues to advance. Enrollment in our Phase III study in adults and adolescents with severe uncontrolled asthma has completed, and we expect the primary analysis in late 2020. We also recently began enrolling patients in the Phase II study of tezepelumab for the treatment of COPD, and we continue to accrue patients on our Phase II atopic dermatitis study.

在發炎領域，我們與阿斯特捷利康在tezepelumab方面的合作仍在繼續。針對患有嚴重未控制氣喘的成人和青少年的 III 期研究的入組工作已經完成，我們預計將在 2020 年底進行主要分析。我們最近也開始招募患者參與 tezepelumab 治療 COPD 的 II 期研究，並且我們繼續招募患者參與 II 期異位性皮膚炎研究。

Also in inflammation, we're enrolling patients in the Phase II study of AMG 570 for the treatment of systemic lupus erythematosus, or SLB. AMG 570 is a first-in-class bispecific antibody-peptide conjugate that targets ICOS ligand, which modulates T cell function and B cell-activating factor, or BAFF. These 2 inflammatory mediators are elevated in SLE and we believe AMG 570 has the potential to provide clinical benefit for patients suffering from this disease.

此外，在發炎方面，我們正在招募患者參與 AMG 570 治療系統性紅斑狼瘡（SLB）的 II 期研究。AMG 570 是一種首創的雙特異性抗體勝肽偶聯物，可針對 ICOS 配體（調節 T 細胞功能）和 B 細胞活化因子（BAFF）。這兩種發炎介質在系統性紅斑狼瘡 (SLE) 中升高，我們相信 AMG 570 有潛力為患有這種疾病的患者帶來臨床益處。

Finally, we continue to enroll proof-of-concept studies with AMG 592, our IL-2 mutein designed to enhance regulatory T cell function in autoimmune diseases, and we expect data from these trials beginning in 2020.

最後，我們繼續進行 AMG 592 的概念驗證研究，AMG 592 是我們設計的 IL-2 突變體，旨在增強自體免疫疾病中的調節性 T 細胞功能，我們預計這些試驗的數據將於 2020 年開始發表。

In bone health, we were pleased that the CHMP issued a positive opinion for EVENITY in the treatment of severe osteoporosis in postmenopausal women at high-risk of fracture and with no history of myocardial infarction or stroke. This is an important step, and along with our partner UCB, we look forward to the European Commission's final decision later this year.

在骨骼健康方面，我們很高興人用藥物委員會 (CHMP) 對 EVENITY 治療停經後婦女嚴重骨質疏鬆症（骨折風險高且無心肌梗塞或中風史）發表了積極意見。這是重要的一步，我們和合作夥伴 UCB 都期待歐盟委員會在今年稍後做出最終決定。

Working closely with the Ministry of Health, Labor and Welfare and the Pharmaceuticals and Medical Devices Agency in Japan, EVENITY's prescribing information was updated by making the potential cardiovascular risk more prominent and adding information to help ensure its proper use.

透過與日本厚生勞動省和藥品醫療器材管理局密切合作，EVENITY 的處方資訊進行了更新，突顯了潛在的心血管風險，並添加了有助於確保正確使用的資訊。

Turning to oncology. I'll begin with AMG 510, our first-in-class KRAS G12C inhibitor. We have the opportunity to present data from 76 patients in our first in-human monotherapy study at the World Lung and ESMO conferences where we reported responses in multiple tumor types with no dose-limiting toxicity.

轉向腫瘤學。我先從AMG 510說起，這是我們首款KRAS G12C抑制劑。我們有機會在世界肺癌大會和歐洲腫瘤內科學會 (ESMO) 大會上展示我們首次人體單藥治療研究的 76 名患者的數據，我們報告了多種腫瘤類型的療效，且無劑量限制性毒性。

In our monotherapy program, our Phase II study in non-small cell lung cancer continues to enroll briskly since initiation in August. We have also rapidly enrolled an initial Phase II cohort of colorectal cancer patients at the target dose, and as the data mature, we will determine the development path in colorectal cancer.

在我們的單藥治療計畫中，自 8 月啟動以來，針對非小細胞肺癌的 II 期研究一直在快速招募患者。我們也迅速招募了一群接受目標劑量治療的大腸直腸癌患者的初始 II 期隊列，隨著數據的成熟，我們將確定大腸直腸癌的開發路徑。

We're also moving forward with a suite of Phase Ib combination studies including PD-1, MEK and other targeted therapies. Our next clinical update will be in 2020 when we have accumulated a meaningful amount of data from these Phase II and combination studies.

我們也正在推進一系列 Ib 期聯合治療研究，包括 PD-1、MEK 和其他標靶療法。我們將於 2020 年發布下一次臨床進展更新，屆時我們將從這些 II 期研究和聯合研究中獲得大量有意義的數據。

In our BiTE development programs, 2 Blincyto Phase III studies in pediatric patients with acute lymphoblastic leukemia at first relapse were stopped early due to the treatment benefit of Blincyto when substituted for a portion of the standard chemotherapy blocks. These results have the potential to be practice-changing since patients with high-risk relapsed ALL have a poor prognosis with standard therapeutic approaches.

在我們的 BiTE 開發項目中，由於 Blincyto 替代部分標準化療方案後對首次復發的急性淋巴細胞白血病兒科患者俱有治療益處，因此 2 項 Blincyto III 期研究提前終止。這些結果有可能改變臨床實踐，因為高風險復發性 ALL 患者採用標準治療方法預後不良。

Later this year, we will be presenting data on AMG 673, a half-life extended BiTE molecule targeting CD33 and AML; AMG 596 directed against EGFRviii in glioblastoma; and we anticipate data for AMG 701, our half-life extended BCMA BiTE molecule next year.

今年晚些時候，我們將公佈 AMG 673 的數據，這是一種半衰期延長的 BiTE 分子，靶向 CD33 和 AML；AMG 596 的數據，靶向膠質母細胞瘤中的 EGFRviii；我們預計明年將公佈 AMG 701 的數據，這是一種半衰期延長的 BCMA BiTE 分子。

In the KYPROLIS program, as Murdo mentioned, the Phase III CANDOR study investigated KYPROLIS, dexamethasone and Darzalex, KDD versus the KYPROLIS-dexamethasone doublet in relapsed or refractory multiple myeloma. The study met its primary progression-free survival or PFS end point with KDD reducing the risk of progression or death by 37% compared to KYPROLIS plus dexamethasone alone.

正如 Murdo 所提到的，在 KYPROLIS 計畫中，III 期 CANDOR 研究調查了 KYPROLIS、地塞米松和 Darzalex (KDD) 與 KYPROLIS-地塞米松雙藥方案在復發或難治性多發性骨髓瘤中的療效。該研究達到了其主要無惡化存活期（PFS）終點，與單獨使用 KYPROLIS 加地塞米松相比，KDD 使疾病惡化或死亡風險降低了 37%。

The median PFS for KYPROLIS plus dexamethasone was 15.8 months, while the median PFS for KDD was not yet reached. These data demonstrate that these 2 potent therapies can be effectively combined and may provide a potential treatment option for patients who have relapsed but need a Revlimid-sparing regimen. We look forward to discussing these results with regulators.

KYPROLIS 合併地塞米松治療的中位 PFS 為 15.8 個月，而 KDD 治療的中位 PFS 尚未達到。這些數據表明，這兩種強效療法可以有效結合，並可能為復發但需要減少瑞復美用量的治療方案的患者提供潛在的治療選擇。我們期待與監管機構討論這些結果。

In hematology, FDA-approved and updated indication for Nplate that expands treatment to newly-diagnosed and persistent adult patients with ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. We have also begun enrolling a Phase III Nplate study for the treatment of chemotherapy-induced thrombocytopenia.

在血液學領域，FDA 批准並更新了 Nplate 的適應症，將治療範圍擴大到對皮質類固醇、免疫球蛋白或脾切除術反應不足的新診斷和持續性 ITP 成年患者。我們也啟動了針對化療引起的血小板減少症的 III 期 Nplate 研究。

Before leaving our therapeutic areas, I'd like to say a few words about the decision we've made to reshape our neuroscience research efforts. We believe that in order to compete effectively, we need to make investments in the areas and platforms that will position us for long-term success. Upon careful evaluation of our pipeline and the challenges inherent in developing drugs for major neurologic diseases, we've made the decision to end our neuroscience research and early development programs with the exception of programs centered on neuro inflammation that will be pursued by our inflammation TA. This was a very difficult decision, and we know it will be a disappointment for our staff and the scientific community.

在離開我們的治療領域之前，我想先就我們所做的重塑神經科學研究工作的決定談幾句。我們認為，為了有效參與競爭，我們需要在能夠幫助我們長期成功的領域和平台上進行投資。經過對我們的研發管線以及開發治療重大神經系統疾病藥物所固有的挑戰的仔細評估，我們決定終止我們的神經科學研究和早期開發項目，但以神經發炎為中心的項目除外，這些項目將由我們的發炎治療領域繼續進行。這是一個非常艱難的決定，我們知道這會讓我們的員工和科學界感到失望。

Over the years, many people at Amgen have devoted time and energy toward developing medicines for patients with neurologic conditions, and I'd like to thank and acknowledge them for their efforts.

多年來，安進公司的許多人投入了大量的時間和精力來研發治療神經系統疾病的藥物，我謹向他們表示感謝和認可。

In particular, bringing Aimovig to migraine patients is the first and innovative new class of medicines with a tremendous achievement. Aimovig is making a meaningful impact on the lives of migraine patients around the world and we will continue to actively support the program including ongoing clinical development. At the same time, we're exploring other models to capitalize on our generics capability and advance our broader efforts in neuroscience, and we'll provide guidance on those activities in the future.

尤其值得一提的是，將 Aimovig 帶給偏頭痛患者是第一個具有巨大成就的創新新藥。Aimovig 正在對世界各地的偏頭痛患者的生活產生有意義的影響，我們將繼續積極支持該項目，包括持續的臨床開發。同時，我們正在探索其他模式，以充分利用我們的仿製藥能力，推進我們在神經科學領域的更廣泛努力，我們將在未來為這些活動提供指導。

Let me conclude with a quick update on biosimilars. Our Phase III non-Hodgkin's lymphoma study of ABP 798, our biosimilar Rituxan, has successfully completed, and we expect to submit a BLA in the U.S. in Q1 2020. And finally, the FDA review of ABP 710, our biosimilar Remicade, continues to progress towards the BsUFA target action date in December.

最後，我簡單介紹一下生物相似藥的最新情況。我們的生物相似藥利妥昔單抗（Rituxan）ABP 798 的 III 期非何杰金氏淋巴瘤研究已成功完成，我們預計將於 2020 年第一季在美國提交生物製品許可申請 (BLA)。最後，FDA 對我們生物相似藥 Remicade（ABP 710）的審查繼續推進，預計將於 12 月達到 BsUFA 目標審批日期。

Bob?

鮑伯？

Okay. Thank you, David. Let's turn over now, Ian, to you and perhaps you can open up the lines for questions and remind our callers of the procedures that will follow.

好的。謝謝你，大衛。現在輪到你了，伊恩，或許你可以接聽提問電話，並提醒來電者接下來的流程。

(Operator Instructions) Our first question is from the line of Ronny Gal from Bernstein.

（操作說明）我們的第一個問題來自伯恩斯坦的 Ronny Gal 的線路。

I'd like to start actually with the last comment you made about ending neuroscience. I'm sure it was a difficult decision, and a lot of us are following it through other companies, and we've seen some really interesting breakthroughs especially when it comes to nucleic acid-based medicine.

我想先談談你上次關於終結神經科學的評論。我相信這是一個艱難的決定，我們很多人都在關注其他公司的發展，而且我們已經看到了一些非常有趣的突破，尤其是在核酸藥物領域。

Can you talk a little bit about that decision, your decision? The other option, obviously, was to double down and go even more innovative. What drove that decision in terms of your thinking? And if you can kind of like coach it in terms of how you feel about the neurology market and what it takes to succeed, that will be great.

您能談談您所做的決定嗎？顯然，另一個選擇是加倍投入，採取更具創新性的方法。從你的角度來看，是什麼促使你做出這個決定？如果你能就你對神經病學市場的看法以及成功所需的條件提供一些指導，那就太好了。

Yes. David, why don't you take a shot at that and I'll offer any thoughts at the back end.

是的。大衛，不如你先試試看，我稍後會提出我的想法。

Yes. Ronny, so this was a very difficult decision. And as you pointed out, there are new therapies becoming available, some of them nucleic acid-based. Many of those, I think, are targeted at orphan or niche diseases. And consistent with our desire to generally target diseases with a large public health impact based on what we felt was the state-of-the-art in terms of understanding the pathogenesis of major diseases, especially neurodegenerative diseases, and our overall portfolio, we made that decision to end our early neuroscience research efforts.

是的。羅尼，所以這是一個非常艱難的決定。正如你所指出的，現在出現了一些新的療法，其中一些是基於核酸的療法。我認為其中很多都是針對罕見疾病或小眾疾病的。出於我們希望針對對公共衛生影響巨大的疾病進行研究的願望，基於我們認為在理解重大疾病（尤其是神經退化性疾病）的發病機制方面最先進的技術水平，以及我們整體的研究組合，我們決定結束早期神經科學研究工作。

As I mentioned, we are looking at ways to maintain a hand in neuroscience through alternative models, and we'll discuss some of that in the future. We believe that genetics will ultimately drive progress in this area, and we'll continue to work with deCODE to generate insights. Bob?

正如我之前提到的，我們正在探索透過替代模型繼續參與神經科學研究的方法，我們將來會討論其中的一些內容。我們相信遺傳學最終將推動該領域的進步，我們將繼續與 deCODE 合作，以獲得新的見解。鮑伯？

I would just add, Ronny, just on the last point that half the genes in the body are expressed in the brain and only the brain, and we think we have some unique resources to try to capitalize on insights around that. And as Dave suggested, we'll be exploring potentially different models for doing that with venture capital and perhaps academic institutions as well.

羅尼，我只想補充一點，關於最後一點，人體內一半的基因只在大腦中表達，我們認為我們有一些獨特的資源，可以嘗試利用這方面的見解。正如戴夫所建議的那樣，我們將探索與風險投資以及學術機構合作的各種可能模式。

And I think more broadly, we're focusing our efforts on where we think we can be successful. So we're focused, as you know, in cardiovascular disease, inflammatory disease and -- oncology, of course. So those are the areas that we're focused on and expect to be successful advancing molecules in those areas over the coming years.

而且我認為更廣泛地說，我們正在將精力集中在我們認為能夠取得成功的地方。如您所知，我們專注於心血管疾病、發炎性疾病以及腫瘤學。所以，這些就是我們關注的領域，我們預期在未來幾年在這些領域成功地推動分子研發。

And our next question is from the line of Do Kim from BMO Capital Markets.

下一個問題來自 BMO 資本市場的 Do Kim。

Just wanted to ask about Otezla. As you look past the closing of the Otezla acquisition, how do you think about the disruption -- potential disruption to the ongoing commercial operations of Otezla? And how long it will take to fully onboard the drug and its components?

只是想問關於奧特茲拉的事。展望 Otezla 收購案的完成，您如何看待此次收購可能對 Otezla 的持續商業營運造成的干擾？藥物及其成分的全面導入需要多長時間？

Yes, thanks, Do. It's Murdo here. We've met with our potential future colleagues several times now around the world at different forums. We met at a few, all staffs and town halls. We've extended conditional offers of employment, and we're really pleased by the uptake there.

是的，謝謝你，Do。我是默多。我們已經在世界各地的不同論壇上與未來的潛在同事們會面過好幾次了。我們在幾次會議上見面，包括全體員工會議和市政廳會議。我們已經發出有條件錄用通知，而且我們對應聘者的接受程度非常滿意。

From Japan to the U.S. and the rest of the world, we see an eager, highly engaged workforce that's very interested in joining Amgen. So I would say that we expect minimal disruption, if any, to ongoing operations. I mean we did set patient continuity as our north star in this integration and everybody has been very focused on following that.

從日本到美國乃至世界其他地區，我們看到了充滿熱情、積極投入的員工隊伍，他們對加入安進公司非常感興趣。因此，我認為我們預計對日常營運的影響將微乎其微，甚至可能完全沒有影響。我的意思是，我們在這次整合中將患者連續性作為我們的指導原則，每個人都非常專注於遵循這項原則。

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。

Just on the Repatha pricing, I know you announced a while back that you're phasing out the higher-priced SKU beginning in next year. But it's been, I think, just over a year, I guess, since you announced this move to have the dual SKUs. And it looks like so far this transition has been a pretty decent success. I mean, looking at numbers, they're relatively stable in the U.S.

關於 Repatha 的定價，我知道你們之前宣布過，從明年開始將逐步淘汰價格較高的 SKU。但我想，距離您宣布採取雙 SKU 策略已經過去一年多了。到目前為止，這種過渡似乎相當成功。我的意思是，從數字上看，它們在美國相對穩定。

So I guess I'm just wondering if commercially, if there have been some learnings from this conversion and actually in this move that can be applied maybe to other areas or perhaps, there's like a healthy distributor margin where high-list price perhaps can impact Medicare patient access.

所以我想知道，從商業角度來看，這次轉型和舉措是否有一些經驗教訓可以應用到其他領域，或者，是否存在健康的經銷商利潤空間，而高昂的標價可能會影響醫療保險患者的獲取途徑。

Yes. Chris, if I understand your question correctly, you're looking to see if there's any lessons learned apply to other products.

是的。克里斯，如果我理解你的問題沒錯的話，你是想看看是否有任何經驗教訓可以應用到其他產品中。

Other therapeutic areas, yes.

其他治療領域，是的。

Yes, in the specialty category. I think lessons have already been learned from Repatha. I think we've applied them to the launch of Aimovig and how we priced that product. I think that, that's been a major reason for why patients have been able to access Aimovig at relatively affordable co-pay levels.

是的，屬於特色類別。我認為我們已經從瑞百莎事件中吸取了教訓。我認為我們已經將這些方法應用到了 Aimovig 的上市以及該產品的定價上。我認為，這正是患者能夠以相對較低的自付費用獲得 Aimovig 的主要原因。

I'm also pleased with the progress we've made on the commercial side with Repatha. I think where it's less clear to us and it's still an area of work in progress is how we are advancing the evolution of access to Repatha at a fixed co-pay-preferred tier benefit in Medicare Part D. We're happy that we're going to go into next year with roughly half of the lives in Medicare Part D being able to access Repatha at an affordable less than $50 co-pay, but we think that number should be much higher. And we think that national plans and PBMs should be moving to add Repatha as a preferred benefit.

我對我們在 Repatha 的商業合作方面取得的進展也感到滿意。我認為我們目前還不太清楚，並且仍在努力改進的領域是，如何在聯邦醫療保險D部分中推進以固定共付額優先級別福利獲得瑞百安（Repatha）的途徑。我們很高興明年將有大約一半的聯邦醫療保險D部分參保人能夠以低於50美元的自付額獲得瑞百安，但我們認為這個數字應該更高。我們認為，國家健保計畫和藥品福利管理機構應該將瑞百安（Repatha）列為首選福利。

So it's a very fragmented health care system with a lot of different actors in the supply chain, and I think that improvements can be made. And we, along with other companies in our industry and our partners on the insurance and PBM side will hopefully come up with better solutions going forward.

所以這是一個非常分散的醫療保健系統，供應鏈中有很多不同的參與者，我認為可以進行改進。希望我們能與業內其他公司以及保險和藥品福利管理的合作夥伴一起，在未來提出更好的解決方案。

And our question is from the line of Geoff Meacham from Bank of America.

我們的問題來自美國銀行的傑夫·米查姆。

Just had one for Murdo. On Aimovig, it's probably the highest profile launch, I think, at Amgen with a lot of prior discussion from you and others on the big unmet need in millions of eligible patients. But when I look at your Slide 15, and I understand the impact payers have on adoption, but why isn't there more of a tipping point more than a year into the launch? If you look at Lily, they've seen good growth as well, but no real inflection point either. So I guess, the question is what do you think is holding back the class? And how could you help accelerate the launch from here?

剛給默多喝了一杯。我認為，Aimovig 可能是安進公司最受矚目的產品發布，此前您和其他人曾就數百萬符合條件的患者的巨大未滿足需求進行過多次討論。但當我看到你的第 15 張投影片時，我理解了支付方對採用率的影響，但是為什麼在推出一年多後還沒有出現更大的轉折點呢？以百合花為例，它們也取得了良好的成長，但也沒有出現真正的轉折點。所以我想問的是，你認為是什麼阻礙了班級的發展？那麼，您能如何幫助加快專案的啟動呢？

Yes. Thank you, Geoff. Look, it's still very early days. And we're pleased with the uptake, over 260,000 patients treated so far with Aimovig since launch. We are really -- if you think about it, we are really only now reaching a point in the market where good access has been provided. We're now at 81% of our prescriptions being paid through some insurance benefit. We're also really only scratching the surface. As you mentioned, looking at roughly 4 million eligible patients in the U.S. alone.

是的。謝謝你，傑夫。你看，現在還為時過早。我們對市場反應感到滿意，自 Aimovig 上市以來，已有超過 26 萬名患者接受了治療。仔細想想，我們現在才真正進入市場，獲得了良好的進入條件。目前，我們81%的處方藥費用都是透過某種保險福利支付的。我們目前也僅僅觸及了皮毛。正如您所提到的，僅在美國就有大約 400 萬名符合條件的患者。

So there's a number of activities. We are investing heavily in direct-to-consumer promotion. We have a very extensive and sophisticated digital campaign, along with, as we have done since the very early days of our work in migraine, been able to activate a lot of the different patient organizations in this area.

所以有很多活動。我們正在大力投資直接面向消費者的推廣活動。我們開展了一項非常廣泛和複雜的數位宣傳活動，並且，正如我們從早期進行偏頭痛研究工作以來所做的那樣，我們能夠調動該領域的許多不同的患者組織。

So I think given the benefit that patients are experiencing with Aimovig, given the way in which it's transforming the lives of migraine sufferers and we see the letters coming in from patients, there's really -- we have a lot of confidence that this market will evolve. And I think throughout the course of 2020, we're looking for changes in the number of new patients that are coming in to the CGRP category on a weekly basis. We're running at around a 7,000-patient per-week clip, new patients to CGRP. We're hoping that, that grows into double digits throughout the course of next year.

所以我認為，鑑於 Aimovig 給患者帶來的益處，鑑於它正在改變偏頭痛患者的生活，而且我們看到了來自患者的信件，我們真的非常有信心，這個市場將會發展壯大。我認為在 2020 年全年，我們將每週觀察 CGRP 類別新增患者數量的變化。我們每周大約有 7,000 名患者接受 CGRP 治療。我們希望這個數字在明年能夠成長到兩位數。

Yes, and Just to add a clinical perspective. The drug works. We've got data out to 4 years now in some patients, and we think that, that foundation will simply lead the increased uptake over time. So we remain very optimistic about the prospects for this. It's really a transformative medicine.

是的，另外補充一點臨床方面的內容。這種藥有效。我們已經獲得了部分患者長達 4 年的數據，我們認為，這項基礎將隨著時間的推移，推動該療法的普及。因此，我們對這項計劃的前景仍然非常樂觀。它真是一種具有變革意義的藥物。

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。

Maybe just 2 from me. Murdo, just wanted to confirm that you said, I think I heard this correctly, that for 2020 you're expecting revenue growth for next year ex Otezla, and then wondering what that assumes for overall price.

或許我只會投兩票。Murdo，我只是想確認一下，我沒聽錯吧，你之前說過，你預計 2020 年的收入增長（不包括 Otezla），然後我想知道這對於整體價格意味著什麼。

And David, on margins, any reason why we would expect a step-down versus of this year? And then on the pipeline, obviously, there's some competitor KRAS data yesterday at a conference, just wondering if you can offer your perspective.

大衛，就利潤率而言，有什麼理由讓我們預期今年的利潤率會比去年有所下降嗎？然後，關於管道方面，顯然，昨天在一個會議上有一些競爭對手的 KRAS 數據，我想知道您是否可以提供您的觀點。

Terence, thanks for the opportunity to clarify. What I said was our base business will be stable going into 2020, and with the anticipated addition of Otezla, we will grow.

特倫斯，謝謝你給我這個澄清的機會。我之前說過，我們的基礎業務在 2020 年將保持穩定，隨著 Otezla 的預期加入，我們將實現成長。

David, I think you've been pretty comprehensive with margins. Do you want to add anything for Terence?

大衛，我覺得你對利潤率的考慮已經非常全面了。你還有什麼要補充給特倫斯的嗎？

No. I've tried to give a preview in terms of the components of cost for next year. And so a combination of what we're doing with revenue and those costs, I think, gives the answer. And I think importantly, we've said in the past and we continue to believe that the company's overall capability in terms of delivering profitability is very good and will continue.

不。我已嘗試對明年的成本構成進行預覽。因此，我認為，結合我們對收入和成本的處理方式，就能得出答案。而且我認為很重要的一點是，我們過去說過，現在仍然相信，公司在實現盈利方面的整體能力非常好，並且會繼續保持這種能力。

Dave, I think there was a third question in there about KRAS.

Dave，我想裡面還有第三個關於 KRAS 的問題。

Yes. Mainly related to this molecule called KRAS. We -- of course, we're aware of the data. I'll let others comment on those data.

是的。主要與一種名為KRAS的分子有關。我們——當然，我們了解這些數據。這些數據就留給其他人評論吧。

As I mentioned, we are enrolling very briskly in our Phase II non-small cell lung cancer program. We've enrolled a cohort in colorectal cancer in Phase II that we believe will inform the development pathway there. And we've got a wide-ranging combination therapy program that's opening up.

正如我之前提到的，我們的 II 期非小細胞肺癌計畫正在快速招募患者。我們已招募了一批大腸直腸癌患者參與 II 期臨床試驗，我們相信這將為該領域的研發路徑提供資訊。我們正在推出一項涵蓋廣泛的聯合療法計劃。

So I think 2020 will be a very data-rich year for the KRAS program, and we'll understand where to go from there.

所以我認為 2020 年對於 KRAS 專案來說將是數據非常豐富的一年，我們將從中了解下一步該怎麼做。

And our next question is from the line of Evan Seigerman from Crédit Suisse.

我們的下一個問題來自瑞士信貸的 Evan Seigerman。

And I want to congratulate David on his retirement, and I wish him the best. And I have a question for the other David, following up on what Terence just asked.

我謹祝賀大衛退休，並祝他一切順利。我還有一個問題想問另一位大衛，這個問題是接著特倫斯剛才提出的問題問的。

So we've seen a lot of KRAS data recently. Much of it remains pretty early. But looking ahead, what is your view on the eventual role of 510 as monotherapy in lung cancer? Or do you ultimately believe that this is probably best served in combination maybe with chemo or a checkpoint? Just to get your thoughts there on how we think about potentially moving that upline.

最近我們看到了很多 KRAS 數據。其中許多內容仍處於早期階段。但展望未來，您認為 510 最終會作為肺癌單藥療法發揮怎樣的作用？或者您最終認為，這種方法最好是與化療或免疫檢查點抑制劑合併使用？只是想聽聽你對我們如何考慮提升上級人選的看法。

Yes. Evan, thanks, and that's a great question. I think the ongoing clinical program is really designed to answer that question in monotherapy. Key things that we will be looking at in the data set over time, in addition to the response rate, will be importantly duration of response and then I think progression-free survival or median progression-free survival.

是的。埃文，謝謝，這是一個很好的問題。我認為正在進行的臨床研究計畫正是為了解答單藥治療中的這個問題而設計的。除了反應率之外，我們將在資料集中長期關注的關鍵指標是反應持續時間，以及無惡化存活期或中位無惡化存活期。

Many of the patients that we've treated to date are third-, fourth-, fifth-line patients where response rates to single-agent chemotherapy are quite low with progression -- median progressions often on the order of a few months. And so those are some of the benchmarks that we'll be looking at in terms of monotherapy.

我們迄今為止治療的許多患者都是三線、四線、五線患者，他們對單藥化療的反應率很低，病情會進展——中位進展時間通常在幾個月左右。因此，這些就是我們將要檢視的單藥治療的一些基準指標。

In terms of combinations in different indications, tumor cells can have very different wiring, and I think as -- over time, as we generate these data sets, we will determine in individual settings whether monotherapy or combination therapy is most appropriate.

就不同適應症的組合而言，腫瘤細胞可能具有非常不同的連接方式，我認為隨著時間的推移，隨著我們產生這些數據集，我們將在具體情況下確定單藥治療或聯合治療哪種最合適。

And then finally, of course, we do have a keen interest in advancing the drug into earlier lines of therapy where we would hope that the magnitude of benefit will be greater. And we will be orienting the development program in that direction as well.

最後，當然，我們也非常希望將該藥物推進到更早期的治療方案中，希望在那裡能獲得更大的益處。我們將把發展計劃朝著這個方向調整。

And our next question is from the line of Yaron Werber from Cowen and Company.

我們的下一個問題來自 Cowen and Company 的 Yaron Werber。

Maybe David, I was going to maybe just ask you another follow-up KRAS question. With -- just piggybacking on what you said, assuming that monotherapy is where you're going to go into in terms of a potential filing path from the Phase II in lung cancer, is -- what is your latest thinking? Is 50% response rate, a PR with 6-month durability, is that really where the latest bogey is for a TKI failure directed? Or is there a chance to file if the data shows you 4.5, 5 months durability, if that's going to be where it ends up?

大衛，我本來想再問你一個關於 KRAS 的後續問題。——就你剛才所說的而言，假設你打算從肺癌 II 期臨床試驗開始，走單藥治療這條潛在的申請路徑，那麼——你最新的想法是什麼？50% 的回應率，6 個月持久性的 PR，這真的是 TKI 失敗的最新目標嗎？如果數據顯示使用壽命只有 4.5 到 5 個月，如果最終結果確實如此，是否還有機會提出索賠？

And then just a question on your formulation. Can you just give us a sense, is that -- what's the size of the tablets in the current 960 mg dose?

然後，我還有一個關於你公式的問題。能大概說一下嗎？目前960毫克劑量的藥片有多大？

Yes, sure. So in terms of the monotherapy, I don't know that I would want to put a stake in the ground there. And it depends also on the patient population in prior lines of therapy. The patients that we have treated to date have all 100% received platinum-based combination chemotherapy, and a very large majority, 90% or so have received a prior checkpoint inhibitor. Beyond that, there are a very few available therapies. And so I think it's against that backdrop that we will be looking at the efficacy and safety results.

當然可以。所以就單一療法而言，我不知道我是否想在這方面表明立場。這也取決於先前接受過多種治療方案的患者群體。到目前為止，我們治療的患者 100% 都接受了以鉑類為基礎的聯合化療，而且絕大多數（約 90%）患者之前都接受過檢查點抑制劑治療。除此之外，可用的治療方法非常有限。所以我認為，我們將在這種背景下審視療效和安全性結果。

In terms of the dosing, the 960 milligrams is 8 tablets. We have not had any reports of tolerability issues, and quite frankly, that part is a nonissue in the program right now.

劑量方面，960毫克相當於8片。我們尚未收到任何關於耐受性問題的報告，坦白說，就目前該專案而言，這部分根本不是問題。

Our next question is from the line of Michael Yee from Jefferies.

我們的下一個問題來自傑富瑞集團的邁克爾葉。

Question for David Reese as well. On BCMA, you've commented that you expect half-life extended data perhaps in early 2020. I wanted to ask your confidence on the ability for that program to move forward to a pivotal, what you're looking for, what's the hurdle? Is there any chance that, that doesn't move into a pivotal? Maybe just comment on that update and what you're looking for.

也向大衛·里斯提出這個問題。在 BCMA 上，您曾表示預計半衰期延長數據可能在 2020 年初公佈。我想問您對該專案能否取得關鍵進展的信心，您在尋找什麼，遇到的障礙是什麼？有沒有可能它不會發展成關鍵事件？或許你可以對那次更新發表一下評論，說說你想要什麼。

Yes. So I think in addition to standard and efficacy and safety, we will be looking at how the molecule stacks up in what's a crowded treatment landscape. Based on what we've seen from the continuous infusion, BiTE molecule, AMG 420, we remain quite enthusiastic about the platform.

是的。所以我認為，除了標準、療效和安全性之外，我們還要考察該分子在競爭激烈的治療領域中的表現。根據我們從連續輸注、BiTE 分子、AMG 420 中看到的情況來看，我們仍然對這個平台充滿熱情。

In general, our approach in the BiTE's, after we've done finding and an expansion cohort, our intention will be generally to progress to a registration phase of the program. And that would be our goal for AMG 701. All of this, of course, is contingent on data that we generate.

總的來說，在 BiTE 計畫中，在完成招募和擴充學員之後，我們的目標通常是推進到計畫的註冊階段。這就是我們對AMG 701的目標。當然，這一切都取決於我們產生的數據。

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

下一個問題來自摩根士丹利的馬修·哈里森。

I wanted to ask Murdo on biosimilars. You gave us a nice sort of run down on some of the market dynamics. I was hoping maybe you could just talk a little bit more detail about what you're seeing in the oncology launches versus the inflammation launches and maybe just give us some sense for what's the breakdown of the revenue mix is right now.

我想問默多關於生物相似藥的問題。您給我們詳細介紹了一些市場動態。我希望您能更詳細地談談您在腫瘤藥物上市和發炎藥物上市方面看到的情況，並讓我們了解目前的收入組成。

Yes. Thank you, Matthew. We're pleased with the U.S. oncology uptake. I think what's really important to note is Amgen's capabilities across our company are known for our strength in biologics manufacturing and providing a reliable quality supply to customers.

是的。謝謝你，馬修。我們對美國腫瘤治療領域的接受度感到滿意。我認為真正需要指出的是，安進公司在生物製劑生產方面實力雄厚，能夠為客戶提供可靠的高品質供應，這一點是眾所周知的。

So I think that first box that you would anticipate oncologist would be concerned about is well checked with the capabilities at Amgen. And we've proven that on our innovative side, and now, we're demonstrating that with being the innovator, total portfolio and, of course, the launch with our biosimilars.

所以我認為，腫瘤科醫師最關心的第一個問題，安進公司在這方面的能力已經得到了很好的滿足。我們在創新方面已經證明了這一點，現在，我們正在透過創新、全面的產品組合以及生物相似藥的上市來證明這一點。

I think from a behavioral standpoint, providers in the oncology market are more than willing to try high-quality biosimilars, and we're seeing good adoption. We're able to open accounts relatively quickly. So our breadth in the community oncology market is good.

我認為從行為學的角度來看，腫瘤市場的供應商非常願意嘗試高品質的生物相似藥，而且我們看到了良好的市場接受度。我們能夠相對快速地開戶。因此，我們在社區腫瘤市場的覆蓋率很廣。

We've provided good coverage in terms of payer reimbursement. And now what we're working on is our non-340B and 340B hospital coverage. And now that we've got permanent J-code -- or permanent coding for reimbursement, we're in really good shape.

我們在支付方報銷方面提供了良好的保障。現在我們正在研究的是如何保障非 340B 和 340B 醫療保險的保障。現在我們有了永久的 J 代碼——或者說是永久的報銷代碼，我們的情況真的很好。

So I think oncologists have behaved very consistent with what we had expected given some of the uptake that we've seen on the supportive care side with the long-acting filgrastim franchise. And I think we're looking forward to continuing to supply those community oncologist providers and academic oncology cancer centers with good commercial services and good patient support as well as that quality and reliable supply that we're known for.

所以我認為，考慮到長效非格司亭產品在支持治療方面的應用，腫瘤科醫師的表現與我們的預期非常一致。我認為我們期待繼續為社區腫瘤醫生和學術腫瘤中心提供良好的商業服務和良好的患者支持，以及我們一貫的高品質和可靠的供應。

Different region, Murdo, but do you want to comment on the experience with inflam in Europe?

Murdo，雖然地區不同，但你想談談在歐洲使用 Inflam 的經驗嗎？

Yes. We've seen very quick uptake and penetration of the biosimilar into the innovator compound with AMGEVITA. We've been pleased to see that despite having multiple products early in the launch of that, all launching at the same time, that we've been able to settle in on price points that are good for our profitability. And as I mentioned earlier, we're also excited now that we've got an on-the-ground, inflammation-focused, customer-facing organization. The addition of Otezla to that is a very efficient one as we go forward.

是的。我們已經看到，AMGEVITA 的生物相似藥很快就被原廠藥吸收和滲透。我們很高興地看到，儘管在產品發布初期我們推出了多款產品，而且所有產品都是同時推出的，但我們仍然能夠確定對盈利能力有利的價格點。正如我之前提到的，我們現在也感到非常興奮，因為我們擁有了一個紮根基層、專注於發炎、面向客戶的組織。奧特茲拉的加入對我們未來的發展來說是一個非常有效的舉措。

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

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

And just so a couple of follow-ups for Dave, if I may. Dave, I'm sure in reviewing a competitor's data, it will not have been lost on you that your competitor has a longer half-life but a greater dosing frequency as well.

如果可以的話，我還想問戴夫幾個後續問題。戴夫，我相信你在查看競爭對手的數據時，肯定已經注意到，你的競爭對手的產品半衰期更長，但給藥頻率也更高。

So wondering, in the context of that, will you be studying BID dosing with 510 in any of the studies? And then could you just talk a bit about ongoing research?

所以我想知道，在這種情況下，你們會在任何研究中研究 510 的 BID 給藥方案嗎？那麼，您能否簡單談談目前正在進行的研究？

And mean this field is obviously exploding. Does Amgen have a continuing research investment in KRAS? And do you have backup molecules that you believe could have some of the attributes that -- compared to these molecules that are emerging that you're going to have?

這意味著這個領域顯然正在蓬勃發展。安進公司是否持續對KRAS進行研究投資？那麼，您是否有備用分子，您認為它們可能具有與即將出現的這些分子相同的某些特性？

Thanks, Geoff. Those are both good questions. I would -- to start, I would say that when we were developing AMG 510, we outlined a set of target parameters for the molecule that we wanted to achieve, biochemically, in terms of pharmacokinetics, et cetera. Most importantly, is the ability to inhibit the target over a dosing interval of 24 hours. We have, we believe, a wealth of data suggesting that with a covalent inhibitor, a couple hours of exposure above a threshold leads to complete inhibition of signaling over that dosing interval. And we're convinced that our 960-milligram dose achieves that and, in fact, is well above that target threshold.

謝謝你，傑夫。這兩個問題都很好。首先，我想說的是，當我們開發 AMG 510 時，我們為分子製定了一系列目標參數，這些參數是我們希望在生物化學、藥物動力學等方面實現的。最重要的是，能夠在 24 小時的給藥間隔內抑制標靶。我們相信，我們有大量數據表明，對於共價抑制劑，暴露於閾值以上幾個小時會導致該給藥間隔內信號傳導完全抑制。我們確信，960 毫克的劑量可以達到這個目標，而且實際上遠高於這個目標閾值。

Now that said, of course, it's very common in small molecule development programs early in the clinical development program to explore alternative doses and schedules, and we will do that as part of the clinical pharmacology program going forward, including split dosing such as BID.

當然，在小分子藥物開發計畫的早期臨床開發階段，探索替代劑量和給藥方案是非常常見的，我們將把這作為未來臨床藥理學計畫的一部分，包括分次給藥，例如每日兩次。

And then finally, as you noted, the field is exploding. That's a fact that is not lost on us. We have a variety of preclinical efforts ongoing there, which we'll be happy to talk about at the right moment in time.

最後，正如你所指出的，這個領域正在爆發式成長。這一點我們心知肚明。我們在那裡進行了各種臨床前研究工作，我們很樂意在適當的時機談論這些工作。

I think it's important, as you follow this field, to keep in mind that not all of those molecules are directly KRAS inhibitors but inhibit other signaling or co-signaling molecules in the pathway or have slightly different mechanisms of action. And as we've seen in oncology over the last several decades, we would expect a sort of plethora of different approaches around these targets.

我認為，在關注這個領域時，重要的是要記住，並非所有這些分子都是直接的 KRAS 抑制劑，而是抑制通路中的其他訊號分子或輔助訊號分子，或具有略微不同的作用機制。正如我們在過去幾十年腫瘤學領域所看到的，我們可以預見，圍繞這些標靶會出現大量不同的治療方法。

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。

David, back to you again on KRAS, as a surprise. We've seen 2 very different AUC disclosures on AMG 510 at the 960 milligram. It was 140 at ASCO, the AUC. And then the AUC declined to 65 at World Lung.

David，驚喜地再次回到KRAS節目。我們看到了 AMG 510 960 毫克劑量下兩種截然不同的 AUC 揭露結果。在 ASCO 和 AUC 上，這一數字為 140。然後，在世界肺臟大會上，AUC 下降到 65。

So my question to you is, what do we know about the median AUC among patients that ended up being responders versus the median AUC among patients that were not responders?

所以我的問題是，我們對最終獲得治療反應的患者的中位 AUC 與未獲得治療反應的患者的中位 AUC 有何了解？

Yes, Umer. Thanks for that. And I would point out that it's not unusual when you initially report Phase I results are often on just a handful of patients. On -- with small molecules, it's typical to have quite large error bars around the various pharmacokinetic estimates. So to see those move over time is not surprising.

是的，烏麥爾。謝謝。我想指出的是，最初報告的 I 期試驗結果通常只涉及少數患者，這並不罕見。對於小分子而言，各種藥物動力學估計值周圍通常存在相當大的誤差範圍。所以，隨著時間的推移，看到這些價格發生變化並不令人驚訝。

And as I mentioned, we're still at a target exposure. In our view, Cmax here is probably the most important parameter, and we believe we're well above our target threshold for quite a number of hours. In fact, essentially through the entire dosing interval, we believe we only need to be above it for a couple of hours to extinguish signaling. So that's really what drove us forward in terms of dose selection in the program. And as I just mentioned, we'll continue to explore other approaches as part of the standard clinical pharmacology program.

正如我之前提到的，我們仍然保持著目標敞口。我們認為，這裡的 Cmax 可能是最重要的參數，而且我們相信，在相當長的一段時間內，我們的 Cmax 都遠高於目標閾值。事實上，我們認為，在整個給藥間隔內，我們只需要保持高於該值幾個小時即可消除訊號。所以，這正是推動我們在方案劑量選擇上取得進展的真正動力。正如我剛才提到的，我們將繼續探索其他方法，作為標準臨床藥理學計劃的一部分。

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

下一個問題來自瑞穗銀行的 Salim Syed。

My congrats to David on his retirement.

恭喜大衛退休。

Just one for me on Neulasta, if I may. So when I look at the NEUPOGEN ASPs over the last 5 years when the biosimilars launched, it seems like you guys have held your ASPs more or less flat over the last 5 years. Meanwhile, the biosimilar ASPs for NEUPOGEN have come down substantially. And I'm wondering how you're thinking about that, given what we're seeing with the Neulasta numbers declining pretty quickly. Should we be expecting a similar strategy here to be price-disciplined? Or what breaks price discipline? Can Sandoz do it? If you can just opine on that.

如果可以的話，我只想問一句關於Neulasta的問題。所以，當我查看過去 5 年 NEUPOGEN 生物類似藥上市後的平均銷售價格 (ASP) 時，似乎你們在過去 5 年裡基本上保持了平均銷售價格不變。同時，NEUPOGEN 的生物相似藥 ASP 已大幅下降。鑑於我們看到 Neulasta 的數量正在迅速下降，我想知道您對此有何看法。我們是否應該預期這裡也會採取類似的價格紀律策略？或者說，什麼會打破價格紀律？山德士能做到嗎？如果你能就此發表一下意見就好了。

Yes, thanks, Salim. The general rule in these types of markets is that the more competition you have, the more number of players, the more price competition you usually see. So I think it's too early to tell in the U.S. in the -- at least the 2 oncology categories we're in with both bevazuzimab and trastuzamab. And I think overall, we're pretty pleased with how price is holding in the long-acting filgrastim arena.

是的，謝謝你，薩利姆。這類市場的一般法則是，競爭越激烈，參與者越多，價格競爭通常就越激烈。所以我認為，在美國，至少在我們目前所處的貝伐珠單抗和曲妥珠單抗這兩個腫瘤治療類別中，現在下結論還為時過早。總的來說，我認為我們對長效非格司亭的價格走勢相當滿意。

I think what we continue to do is make sure that people understand that our ability to supply a high-quality product with reliability of that supply, along with our patient programs, we're able to hold on to share quite well. And there's usually some ability for the innovator to hold on to share even at a price premium, and that's usually in the 10% to 20% range.

我認為我們一直在做的是確保人們理解，憑藉我們可靠的高品質產品供應能力，以及我們的患者項目，我們能夠很好地保持市場份額。創新者通常有能力在價格溢價的情況下保持一定的市場份額，這個份額通常在 10% 到 20% 之間。

And our next question is from the line of Jay Olson from Oppenheimer.

我們的下一個問題來自奧本海默公司的傑伊·奧爾森。

I'm curious about tezepelumab. Congratulations on completing enrollment of the 1,000 patient NAVIGATOR study. Can you describe the plans for submitting a BLA? You have a number of other studies running, including a steroid-sparing study in adults.

我對tezepelumab很有興趣。恭喜你們完成了1000名患者的NAVIGATOR研究招募工作。可否介紹一下提交生物製品許可申請（BLA）的計畫？您還有其他一些研究正在進行中，包括一項針對成年人的類固醇替代研究。

What do you -- what data do you need, and what is the time line to file? And then as you contemplate commercialization, who are the target prescribers? And how will tezepelumab fit into your commercial infrastructure?

你需要哪些數據？提交申請的時間安排是怎樣的？那麼，在考慮商業化的時候，目標處方醫生是誰呢？tezepelumab 將如何融入您的商業體系？

Let's take it 2 parts. Dave, why don't you start?

我們把它分成兩部分來討論。戴夫，你為什麼不先開始呢？

Yes, I'll start. Typically, we don't comment on regulatory filing time lines. I would point out, as you mentioned, the core of any filing package will be NAVIGATOR study. And there are a number of other studies that will provide supportive data. We expect -- those studies are 52 weeks in duration. And so given that we completed enrollment to that trial you can expect roughly a little after a year from last patient enrolled that the primary analysis reads out, following within -- following that would then be filing.

好的，我先來。通常情況下，我們不會對監管申報時間表發表評論。正如您所提到的，我想指出的是，任何申報資料的核心都將是 NAVIGATOR 研究。還有許多其他研究將提供支持性數據。我們預計—這些研究將持續 52 週。因此，鑑於我們已經完成了該試驗的招募，您可以預計在最後一名患者入組後大約一年多一點的時間裡，主要分析結果將會公佈，隨後——之後就是提交文件。

Let me turn it over to Murdo who can address some of our commercial thoughts on the opportunity for tezepelumab.

讓我把麥克風交給 Murdo，他可以談談我們對 tezepelumab 的商業前景的一些想法。

Yes. Clearly, we're working very closely with our partners at AstraZeneca who are very experienced in this area across respirology, pulmonology and even allergists, which are our target customers for at least the asthma indications. So a lot of work being done there, and we're looking forward to hopefully successful data and approval.

是的。顯然，我們正在與阿斯特捷利康的合作夥伴密切合作，他們在呼吸病學、肺病學甚至過敏症領域都擁有非常豐富的經驗，而過敏症正是我們至少在氣喘適應症方面的目標客戶。所以那邊正在做很多工作，我們期待著能夠獲得成功的數據和批准。

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 guess I'll skip another KRAS one, instead ask on the BD front. So given that you recently announced a meaningful transaction for Otezla, and now, you have CFO transitions going to be taking place, would it be fair to assume that you'd hit the pause button on other deals in the near to intermediate term? Or is it basically business as usual during this transition?

我想我還是跳過 KRAS 的問題，轉而詢問 BD 方面的問題吧。鑑於您最近宣布了對 Otezla 的一項重大交易，而且現在您還將進行首席財務官的更迭，那麼是否可以合理地假設您會在近期或中期內暫停其他交易？或者說，過渡期間一切照舊？

Well, I think it's very much business as usual, Cory. We're very clear that our capital allocation priorities remain intact. We're continuing to look for ways to invest internally, externally, and while also growing the dividend by next year. So we've got an active BD effort in those areas of our stated strategic focus, therapeutically and geographically, and we'll maintain that.

嗯，我覺得一切照舊，科里。我們非常明確，我們的資本配置優先事項保持不變。我們將繼續尋找內部和外部投資途徑，同時爭取在明年提高股利。因此，我們在既定的策略重點領域（包括治療領域和地理方面）積極開展業務拓展工作，並將繼續保持這種勢頭。

Ian, as it's past 6:00 p.m. on the East Coast, why don't we take 2 last questions, after which, Bob will make a few concluding comments.

伊恩，現在已經過了下午6點了。在東岸，我們不妨再回答最後兩個問題，之後，鮑伯將作一些總結性評論。

Our next question is from the line of Mohit Bansal from Citigroup.

我們的下一個問題來自花旗集團的莫希特·班薩爾。

And I would like to start with thanking David for all the help over the years. Moving to KRAS, we have recently learned that patients with Ltv1 mutations do not respond well to checkpoint inhibitors and they also represent about 30% of KRAS-mutated cancer. So just wanted to see if this is an idea you have looked at, and could this be your entry as a first-line agent for your AMG 510?

首先，我要感謝大衛多年來的幫助。再來看 KRAS，我們最近了解到，攜帶 Ltv1 突變的患者對檢查點抑制劑的反應不佳，而且他們也佔 KRAS 突變癌症的約 30%。所以我想看看您是否考慮過這個想法，這是否可以成為您作為AMG 510一線代理商的切入點？

Thanks, Mohit, and that's a great question. So we've got a very active biomarker program. We are sequencing as many of these tumors as we can. And as we accumulate a larger number of patients who are both responders and non-responders, we will look to see if there are signatures, molecular signatures that predict response or lack of response.

謝謝莫希特，這是一個很好的問題。所以我們有一個非常活躍的生物標誌物項目。我們正在盡可能地對這些腫瘤進行測序。隨著我們累積越來越多的有反應和無反應的患者，我們將研究是否存在可以預測反應或無反應的特徵或分子特徵。

The particular mutation that you called out is one, of course, that we will be keenly focused on. And as you mentioned, it seems to associate with relative resistance to checkpoint inhibitors. So I think there's a lot to learn. It took 40 years to get into the clinic with an inhibitor. We've been there a year. We are very rapidly generating data. I would think that when we present clinical data next year, we will also be able to have a first pass at a fair amount of biomarker data as well.

當然，您提到的那種特定突變正是我們將重點關注的對象。正如您所提到的，這似乎與對檢查點抑制劑的相對抗藥性有關。所以我覺得有很多東西要學習。花了 40 年將抑制劑引入臨床。我們在那裡待了一年了。我們正在快速產生數據。我認為，當我們明年公佈臨床數據時，我們也將能夠初步獲得相當數量的生物標記數據。

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

最後一個問題來自加拿大皇家銀行資本市場的 Kennen MacKay。

Let me offer my congrats on the quarter and guidance raise as well as congrats on the decision to pull the high-priced Repatha from the market by New Year's Eve. And on that note, just a question for Murdo.

我要祝賀貴公司本季業績和業績預期上調，同時也祝賀貴公司決定在新年夜前將高價藥物 Repatha 從市場上撤下。說到這裡，我有個問題想問默多。

Repatha's share of the PCSK9 market has increasingly gained over Praluent over the last couple of years. I was wondering if you could comment on what you see is the big driver for that, and also how you're thinking about the potential competitive impacts of the entry of bempedoic acid and inclisiran in high cholesterol?

在過去幾年裡，Repatha 在 PCSK9 市場的市佔率不斷超過 Praluent。我想請您談談您認為推動這一趨勢的主要因素是什麼，以及您如何看待貝培多酸和英克立西蘭進入高膽固醇治療領域可能帶來的競爭影響？

Thanks, Kennen. So why don't I start with the Repatha question, and then perhaps, turn it to Dave Reese to talk about the development of other competitors in the cholesterol-lowering category.

謝謝你，肯南。那麼，我先從瑞百安（Repatha）的問題開始，然後或許可以請戴夫·里斯（Dave Reese）談談降膽固醇藥物領域其他競爭對手的發展。

First off, thank you for recognizing the price -- sorry, the decision to remove the OLP from the market. I think this was something we signaled, but it's something we feel is important to do to ensure that other actors in the supply chain make the right decision and provide the low list price Repatha on their formularies and within their benefits so that patients can lower their out-of-pocket costs.

首先，感謝您認可將 OLP 從市場上撤下的價格——抱歉，是撤下 OLP 的決定。我認為這是我們之前發出的信號，但我們覺得這樣做很重要，以確保供應鏈中的其他參與者做出正確的決定，並在他們的處方集和福利範圍內提供低價的Repatha，以便患者可以降低他們的自付費用。

So this is one where we've worked very closely with payers, and we've made sure that both the prescribing community and patients understand what we're trying to do here, and that's to provide a very effective medicine for serious cardiovascular disease patients who can benefit from it.

因此，我們與支付方密切合作，確保處方醫生和患者都了解我們正在努力的方向，那就是為能夠從中受益的嚴重心血管疾病患者提供非常有效的藥物。

Overall, I think the execution on the ground has been very, very strong. The field teams, both on the medical side and on the commercial side, that are calling on cardiology have been very good at explaining who the ideal high-risk cardiovascular patient candidate is for Repatha.

總的來說，我認為實際執行情況非常非常出色。無論是醫療方面還是商業方面，拜訪心臟科醫生的現場團隊都非常擅長解釋 Repatha 的理想高風險心血管患者候選人是誰。

And so we're running at approximately 70% share right now. We don't see that declining. We see it holding or modestly increasing. We'll continue to invest in Repatha to ensure that prescribers and patients alike receive the option of using Repatha to lower cholesterol and to reduce cardiovascular risk going forward.

所以，我們目前的市佔率大約是 70%。我們認為這種情況不會惡化。我們看到它保持穩定或略有增長。我們將繼續投資瑞百安，以確保處方醫生和患者將來都能選擇使用瑞百安來降低膽固醇和減少心血管風險。

So we're feeling confident, and we're feeling like we're finally making some inroads here in addressing these -- the risk reduction for these patients.

所以我們感到充滿信心，並且感覺到我們終於在解決這些問題上取得了一些進展——降低這些患者的風險。

Yes. And in terms of other LDL-targeting molecules, bempedoic acid is an oral. We think it is really going to occupy different niche in the clinical landscape. This will be used either on top of statins or with patients who are close to goal or in those who are not tolerant to statins.

是的。至於其他針對 LDL 的分子，貝培多酸是一種口服藥物。我們認為它將在臨床領域佔據一個全新的地位。這種藥物可以與他汀類藥物合併使用，也可以用於接近治療目標的患者或對他汀類藥物不耐受的患者。

We don't -- it's got a modest LDL-lowering effect. We really don't see it as a direct competitor to Repatha. Inclisiran, I think, what we will pay attention to in the long term are long-term safety, and then of course, cardiovascular outcomes data, which are still, we think, some years out. That's what we'll be looking for in that space.

我們不這麼認為——它只有輕微的降低低密度脂蛋白膽固醇的作用。我們並不認為它是瑞百莎的直接競爭對手。我認為，從長遠來看，我們關注 Inclisiran 的重點是長期安全性，當然還有心血管結果數據，我們認為這些數據還需要幾年時間才能獲得。這就是我們將在該領域尋找的東西。

And I think now I'll turn it back over to Bob.

我想現在該把這件事交還給鮑伯了。

Okay. Thank you. Let's wrap up.

好的。謝謝。我們來總結一下。

Let me just note that we're pleased with our performance through the first 9 months of the year. We hope to share our enthusiasm for the long-term outlook at Amgen driven by our recently launched innovative products as well as our biosimilar medicines and our rapidly advancing pipeline opportunities.

我想指出的是，我們對今年前九個月的業績感到滿意。我們希望與大家分享我們對安進長期前景的熱情，這種熱情源自於我們近期推出的創新產品、生物相似藥以及我們快速推進的研發管線。

We think we're in a strong position to deliver long-term performance for our shareholders and the patients whose needs we're seeking to address.

我們認為我們處於有利地位，能夠為我們的股東和我們致力於滿足其需求的患者帶來長期的表現。

And as previously announced, David Meline will be retiring next year. And though this is not his last call with investors, I wanted to take a moment, fresh from his announcement, to thank him publicly for his contributions. He's been an extraordinary leader for us as our CFO, and he will leave Amgen a strengthened enterprise.

正如之前宣布的那樣，大衛梅林將於明年退休。雖然這並非他與投資者的最後一次通話，但我想趁著他剛剛宣布這一消息，公開感謝他所做的貢獻。作為我們的財務官，他是一位傑出的領導者，當他離開時，安進公司將變得更加強大。

At the same time, I'm delighted to welcome Peter Griffith to Amgen as David's successor. And Peter's extensive financial and operational experience will benefit Amgen as we continue our efforts globally to serve more patients and drive long-term growth.

同時，我很高興地歡迎彼得·格里菲斯加入安進公司，接替大衛的職位。Peter豐富的財務和營運經驗將使安進受益，我們將繼續在全球範圍內為更多患者提供服務，並推動長期成長。

I know the whole team joins me in welcoming Peter aboard, and we look forward to introducing him to all of you.

我知道整個團隊都跟我一樣歡迎彼得加入，我們期待著把他介紹給大家。

Finally, I'd be remiss if I didn't also thank the Amgen staff around the world who continue to deliver on our mission to serve patients and to drive value for our shareholders.

最後，如果我不感謝安進公司世界各地的員工，那就太失職了。他們繼續履行我們服務患者和為股東創造價值的使命。

Thanks for your interest in the company, and we look forward to talking to you on the next call.

感謝您對本公司的關注，我們期待在下次通話中與您交流。

Great. Thanks to all of you for your participation.

偉大的。感謝各位的參與。

If you'd like to continue the dialogue, feel free to call me. The IR team will be standing by for several hours.

如果您想繼續對話，請隨時打電話給我。IR團隊將待命數小時。

Thanks again.

再次感謝。

Ladies and gentlemen, this does conclude today's conference. We thank you greatly for joining us for Amgen's Third Quarter 2019 Financial Results Conference Call.

女士們、先生們，今天的會議到此結束。非常感謝您參加安進公司2019年第三季財務業績電話會議。

You may now disconnect.

您現在可以斷開連線了。