美國安進 (AMGN) 2018 Q4 法說會逐字稿

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

我叫伊恩，今天我將擔任安進 2018 年第四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. Let's go ahead and jump right in as we have a lot of ground to cover.

好的，謝謝你，伊恩。大家下午好。感謝您今天收看我們的節目。咱們直接進入正題吧，因為要講的內容很多。

I think 2018 is a good illustration of how the capabilities we have developed over the past 5 years will help drive long-term growth for our shareholders. To describe this in much greater detail, I'm joined today by our Chairman and CEO, Bob Bradway. After Bob's strategic overview, our CFO, David Meline, will review our financial results for the fourth quarter and the full year 2018 and provide guidance for 2019. Our Head of Global Commercial Operations, Murdo Gordon, will then review our product performance; following which, Dave Reese, our Head of R&D, will provide a pipeline update. We will use slides to guide our discussion today, and you should have received a link separately.

我認為 2018 年很好地說明了我們在過去 5 年中培養的能力將如何幫助推動股東的長期成長。為了更詳細地描述這一點，今天我邀請了我們的董事長兼執行長鮑勃·布拉德韋。在鮑伯進行策略概述之後，我們的財務長大衛梅林將審查我們 2018 年第四季和全年的財務業績，並對 2019 年提供指導。接下來，我們的全球商業營運主管 Murdo Gordon 將回顧我們的產品表現；隨後，我們的研發主管 Dave Reese 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，您應該已經單獨收到連結。

Just a 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.

提醒各位，我們今天的演示將使用非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. Thank you, Arvind, and let me welcome all of you to our fourth quarter call. While the bulk of this call will be dedicated to discussing our performance in 2018 and our outlook for 2019, I'd like to begin the call today by discussing the transformation journey we've been on at Amgen for the past 5 years. One aspect of that transformation was significantly improved financial performance. 5 years ago, we made a number of financial commitments, earnings per share, margin expansion, and so forth. I am pleased to announce that we met or exceeded each one of these ambitious financial targets. David will provide more specifics on this in a few moments.

好的。謝謝 Arvind，也歡迎各位參加我們的第四季電話會議。雖然本次電話會議的大部分時間將用於討論我們在 2018 年的業績以及我們對 2019 年的展望，但今天我想首先討論一下安進在過去 5 年裡所經歷的轉型之旅。這一轉變的一個面向是財務表現顯著改善。5年前，我們做出了一系列財務承諾，包括每股盈餘、利潤率擴張等等。我很高興地宣布，我們已達到或超越了所有這些雄心勃勃的財務目標。大衛稍後會提供更多細節。

The larger goal of our transformation, however, was to dramatically enhance our ability to compete. And here, too, we've made great progress. Over the past 5 years, we launched 9 new products, including in 2 new therapeutic areas; expanded our global presence to about 100 countries; generated our largest ever number of innovative and first-in-class molecules in our pipeline; reduced our development cycle time by an average of about 36 months; expanded our industry-leading human genetics capabilities; stood up a biosimilars business; and deployed a first of its kind, highly efficient, next-generation biologics manufacturing capability. While our transformation is not complete, we're in a much better position than ever before to serve patients and to deliver long-term growth.

然而，我們轉型的更大目標是大幅提升我們的競爭力。在這方面，我們也取得了巨大進展。過去 5 年，我們推出了 9 款新產品，涵蓋 2 個新的治療領域；將我們的全球業務拓展到約 100 個國家；在我們的研發管線中產生了有史以來數量最多的創新型和同類首創分子；將我們的研發週期平均縮短了約 36 個月；擴展了我們行業領先的人類遺傳學能力；雖然我們的轉型尚未完成，但我們現在比以往任何時候都更有能力為患者服務並實現長期成長。

Our performance in 2018 is a good example of our capabilities. We generated double-digit, volume-driven growth, which is a key focus of our strategy, from innovative medicines that address serious unmet needs, including Repatha in cardiovascular disease, Prolia in osteoporosis, KYPROLIS in cancer and Aimovig in migraine. Our ability to develop and commercialize innovative therapies is particularly illustrated in the early success of Aimovig, our first-in-class, differentiated biologic for the prevention of migraine, where we quickly established and have since maintained a leadership position. We also believe that biosimilars represent an important, evolving growth opportunity. We achieved several important milestones with our biosimilars portfolio last year, including our first 2 launches, and we expect many more milestones in the years to come. Life cycle management has also been an important source of our performance over the last several years. We believe we will continue to generate strong cash flows from mature brands, including Enbrel, Neulasta, and our ESA and calcimimetic franchises. Murdo will provide more details in a moment about our commercial success.

我們在2018年的表現很好地體現了我們的能力。我們實現了兩位數的銷售驅動成長，這是我們策略的一個重點，這得益於創新藥物，這些藥物可以解決嚴重的未滿足需求，包括治療心血管疾病的 Repatha、治療骨質疏鬆症的 Prolia、治療癌症的 KYPROLIS 和治療偏頭痛的 Aimovig。我們開發和商業化創新療法的能力尤其體現在 Aimovig 的早期成功上，Aimovig 是我們首創的、差異化的偏頭痛預防生物製劑，我們迅速確立了領先地位，並且此後一直保持著這一地位。我們也認為，生物相似藥代表著一個重要的、不斷發展的成長機會。去年，我們的生物相似藥產品組合取得了幾個重要的里程碑，包括我們首次推出的兩款產品，我們預計在未來幾年還將取得更多里程碑式的成就。在過去幾年裡，生命週期管理也是我們業績成長的重要因素。我們相信，我們將繼續從成熟品牌（包括 Enbrel、Neulasta 以及我們的 ESA 和鈣敏感受體激動劑產品線）中獲得強勁的現金流。Murdo 稍後將詳細介紹我們的商業成功。

Our R&D strategy is aimed at advancing differentiated, best-in-class or first-in-class molecules that deliver large effect sizes against serious illnesses. We have made tremendous progress both in terms of the quantity and quality of potential new medicines in our innovative pipeline. We continue to leverage our industry-leading human genetics work at deCODE to identify, prioritize and accelerate R&D programs with genetic validation. And we've made great strides with respect to the speed with which we are advancing our pipeline, cutting years out of the cycle time for certain molecules, several of which will have important data read-outs this year. Dave Reese will cover our position in R&D in greater detail momentarily.

我們的研發策略旨在推動差異化、一流或首創的分子藥物的研發，以期對嚴重疾病產生顯著療效。我們在創新研發管線中潛在新藥的數量和品質方面都取得了巨大進步。我們將繼續利用 deCODE 業界領先的人類遺傳學工作，確定、優先考慮並加速具有遺傳驗證的研發專案。我們在推動研發管線的速度方面取得了巨大進步，某些分子的研發週期縮短了數年，其中幾種分子將在今年獲得重要的數據讀數。戴夫·里斯稍後將更詳細地介紹我們在研發方面的地位。

As you're well aware, innovation is flourishing in our industry, and with the flow of new medicines, there are acute concerns about the price of innovative therapies and ensuring patients have access to them. We remain committed to working with the administration and congressional leaders in the House and Senate as well as stakeholders throughout the health care system to address concerns over the cost of prescription drugs without sacrificing innovation. You will recall our decision to forego price increases scheduled for July of last year as well as our recent decision to lower the list price of Repatha by 60%. In fact, our net selling prices declined in 2018 and will decline further in 2019. For many Amgen medicines, there are no planned price increases. As has been the case for the past few years, our strategy for growth will be driven by volume, not price. Our fourth quarter product sales growth of 8% is evidence of our ability to succeed in this new environment.

如您所知，創新在我們這個行業蓬勃發展，隨著新藥的不斷湧現，人們對創新療法的價格以及如何確保患者能夠獲得這些療法感到非常擔憂。我們將繼續致力於與政府和國會眾議院和參議院的領導人以及整個醫療保健系統的利益相關者合作，在不犧牲創新的前提下，解決處方藥成本問題。您應該還記得我們去年決定放棄原定於 7 月的價格上漲計劃，以及我們最近決定將 Repatha 的價格降低 60%。事實上，我們的淨售價在 2018 年有所下降，2019 年還將進一步下降。安進公司生產的許多藥品目前沒有漲價計畫。與過去幾年一樣，我們的成長策略將以銷售而非價格為驅動力。我們第四季產品銷售額成長了 8%，證明了我們有能力在新環境中取得成功。

With a solid balance sheet, strong and consistent free cash flow generation, robust investments across the portfolio and a thoughtful capital deployment strategy, we are confident in our ability to drive long-term, volume-driven growth and provide attractive returns for our shareholders. I'm excited about the future of Amgen and the potential for long-term growth, driven by medicines like Repatha, Prolia, KYPROLIS and Aimovig, our emerging portfolio of biosimilars and the many potential new innovations advancing rapidly through our pipeline. While we have profoundly transformed the company over the last several years, our mission to serve patients has not changed. And on that note, I'd like to thank my Amgen colleagues around the globe for their continued devotion to supporting Amgen's mission to serve patients.

憑藉穩健的資產負債表、強勁且持續的自由現金流、穩健的投資組合以及周全的資本部署策略，我們有信心推動長期、銷售驅動的成長，並為股東提供可觀的回報。我對安進的未來以及長期成長的潛力感到興奮，這得益於 Repatha、Prolia、KYPROLIS 和 Aimovig 等藥物，我們新興的生物相似藥產品組合，以及我們研發管線中正在快速推進的眾多潛在創新。儘管過去幾年我們對公司進行了深刻的變革，但我們服務患者的使命始終不變。在此，我要感謝安進全球各地的同事們，感謝他們一直以來對支持安進服務患者的使命所做的貢獻。

With that, let me turn the call over to David Meline, our Chief Financial Officer.

接下來，我將把電話交給我們的財務長大衛梅林。

Okay. Thanks, Bob. Before reviewing our results and guidance, I would also like to take a moment to reflect on our performance over the last several years. In 2013, we anticipated the coming realities of an increasingly competitive and dynamic industry landscape. Accordingly, we embarked on an organizational initiative to prepare for long-term success by transforming the business to achieve maximum speed, agility and efficiency. We also set aggressive operational goals for the period through 2018 that would enable us to better serve patients and deliver solid, sustainable returns to shareholders while investing to ensure the long-term health of the business. As we have now completed the first 5 years of our transformation, I wanted to summarize the results of our efforts.

好的。謝謝你，鮑伯。在回顧我們的業績和展望之前，我還想花點時間回顧一下我們過去幾年的表現。2013年，我們預見了競爭日益激烈、瞬息萬變的產業格局即將帶來的現實。因此，我們啟動了一項組織計劃，透過變革業務以實現最大的速度、敏捷性和效率，為長期成功做好準備。我們也為 2018 年設定了積極的營運目標，這將使我們能夠更好地服務患者，並為股東帶來穩健、可持續的回報，同時進行投資以確保業務的長期健康發展。現在，我們的轉型已經走過了第一個五年，我想總結一下我們努力的成果。

First, I'm pleased to confirm that we achieved double-digit non-GAAP EPS growth with 14% annual growth for the period, with EPS rising from $7.60 to $14.40 or 89% in the period. Second, we exceeded our $1.5 billion gross cost savings target by delivering $1.9 billion of annual savings versus the 2013 base. Transformation efforts reduced 2018 operating expense on a like-for-like basis as a percent of sales by 9 percentage points. It is important to recognize that we delivered these financial results while launching multiple products and building new capabilities. Third, we had an operational goal to achieve significant improvement in our operating efficiency, agility and speed with the resulting outcome of a non-GAAP operating margin between 52% and 54% by 2018, a goal that at the midpoint represented a 15 point margin improvement. As you know, we achieved this objective starting in 2016, 2 years ahead of our commitment. Fourth, through our next-generation biomanufacturing capability as well as other efforts to optimize our fixed capital infrastructure, we reduced our facility footprint by about 24%, exceeding our target of 23% footprint reduction. Finally, based on today's 2018 earnings report, we provided returns to shareholders of 89% or $42 billion in total, well above our goal of returning at least 60% of non-GAAP net income on average during the 2014 to '18 period. In summary, we delivered on all of our commitments, which positions Amgen very well for the next phase of its development.

首先，我很高興地確認，我們實現了兩位數的非GAAP每股收益成長，該期間年增長率為14%，每股收益從7.60美元增長到14.40美元，增幅達89%。其次，我們實現了 19 億美元的年度成本節約，超過了 15 億美元的總成本節約目標（與 2013 年的基準相比）。轉型措施使 2018 年營運費用佔銷售額的百分比降低了 9 個百分點（以可比較口徑計算）。值得注意的是，我們在推出多款產品和建立新能力的同時，也實現了這些財務表現。第三，我們的營運目標是在營運效率、靈活性和速度方面取得顯著進步，到 2018 年實現非 GAAP 營運利潤率達到 52% 至 54%，該目標的中點值代表利潤率提高 15 個百分點。如您所知，我們從 2016 年開始就實現了這一目標，比我們承諾的時間提前了 2 年。第四，透過我們的下一代生物製造能力以及其他優化固定資本基礎設施的努力，我們將設施佔地面積減少了約 24%，超過了我們減少 23% 佔地面積的目標。最後，根據今天發布的 2018 年收益報告，我們為股東帶來了 89% 的回報，總計 420 億美元，遠高於我們在 2014 年至 2018 年期間平均至少返還 60% 非 GAAP 淨收入的目標。總而言之，我們履行了所有承諾，這使安進公司在下一階段的發展中處於非常有利的地位。

Looking ahead, we are excited to build on our recent transformation successes, including maintaining and improving on our leading process development and manufacturing capabilities, driving our research and development innovation, and continuing to build our market and global presence. Additionally, we're embedding a permanent productivity capability into our business. We expect our productivity capability will continue to support disciplined cost management, contribute to funding strategic growth investments, such as the 2019 investment in our early oncology programs, and continued optimization of our operating model.

展望未來，我們很高興能夠在近期轉型成功的基礎上繼續發展，包括保持和提高我們領先的製程開發和製造能力，推動我們的研發創新，並繼續擴大我們的市場和全球影響力。此外，我們正在將永久性生產力能力融入我們的業務中。我們期望我們的生產能力將繼續支持嚴格的成本管理，為策略性成長投資提供資金，例如 2019 年對早期腫瘤學計畫的投資，以及持續優化我們的營運模式。

Now let's turn to the fourth quarter financial results on Page 7 of the slide deck. Revenues at $6.2 billion increased 7% year-over-year. This quarter, we saw worldwide product sales growth to $6 billion as unit demand from our growth and launched products more than offset mature product declines. We are particularly encouraged by our 10% year-over-year volume growth in total worldwide business. Foreign exchange had a negative 1% impact to fourth quarter worldwide sales on a year-over-year basis. Other revenues at $229 million were down 2% versus 2017. Our Q4 non-GAAP operating income at $2.7 billion increased 6% from prior year. Non-GAAP operating margin was 45.3% for the quarter.

現在讓我們來看看投影片第 7 頁的第四季財務表現。營收達 62 億美元，年增 7%。本季度，全球產品銷售額成長至 60 億美元，成長和新推出的產品的單位需求超過了成熟產品的下滑。我們尤其感到鼓舞的是，全球業務總量年增了 10%。外匯波動對第四季全球銷售額較去年同期產生了1%的負面影響。其他收入為 2.29 億美元，比 2017 年下降了 2%。我們第四季非GAAP營業收入為27億美元，比上年同期成長6%。本季非GAAP營業利益率為45.3%。

As previously indicated, our operating expenses reflected the typical underlying fourth quarter pattern. We also increased investment in Aimovig in support of its rapid growth as well as other in-market products in support of greater volume-driven growth. Additionally, this quarter, we invested an incremental $90 million year-over-year in external innovation opportunities, including expansion of our genetics capability. These increases were partially offset by continued favorable expense impacts from our transformation initiatives across all operating expense categories. Other income and expenses were a net $197 million expense in Q4. This is unfavorable by $166 million on a year-over-year basis. This year-over-year unfavorability was due primarily to lower interest income on lower cash balances as well as market value fluctuations of publicly traded securities held in our ventures portfolio. The non-GAAP tax rate was 13.3% for the quarter, a 3.3 point improvement versus Q4 of 2017, reflecting favorable impacts of U.S. corporate tax reform.

如前所述，我們的營運費用反映了典型的第四季基本模式。我們還增加了對 Aimovig 的投資，以支持其快速成長，並增加了對其他在售產品的投資，以支持更大的銷售驅動成長。此外，本季我們在外部創新機會方面比去年同期增加了 9,000 萬美元的投資，包括擴大我們的基因技術能力。這些成長被我們轉型計劃在所有營運費用類別中持續帶來的有利影響部分抵消。第四季其他收入和支出淨額為 1.97 億美元。與上年同期相比，這不利了1.66億美元。與去年同期相比，這種不利局面主要是由於現金餘額減少導致利息收入下降，以及我們創投組合中持有的公開交易證券的市場價值波動所造成的。本季非GAAP稅率為13.3%，比2017年第四季提高了3.3個百分點，反映了美國企業稅制改革的有利影響。

Non-GAAP net income increased 4%, and non-GAAP earnings per share increased 18% year-over-year for the fourth quarter, supported by a 12% reduction in share count versus Q4 of 2017.

第四季非GAAP淨利成長4%，非GAAP每股盈餘較去年同期成長18%，這得益於與2017年第四季相比，股份數量減少了12%。

Please find a summary of our 2018 full year results on Page 8 of the presentation. Our 2018 full year revenues increased 4% to $23.7 billion, where our non-GAAP earnings per share grew 14% to $14.40 per share. For the full year, we saw a 3% increase in worldwide product sales growth at $22.5 billion. Other revenues increased $160 million to $1.1 billion, due largely to the year-over-year favorable impact of milestone payments. For the full year, non-GAAP operating income at $11.9 billion grew 2% from the prior year, and our non-GAAP operating margin was 52.6% for the year.

請參閱簡報第 8 頁，以了解我們 2018 年全年業績的摘要。2018 年全年營收成長 4% 至 237 億美元，非 GAAP 每股盈餘成長 14% 至每股 14.40 美元。全年來看，全球產品銷售額成長了 3%，達到 225 億美元。其他收入增加 1.6 億美元，達到 11 億美元，這主要歸功於里程碑付款帶來的同比利好影響。全年非GAAP營業收入為119億美元，較上年成長2%，全年非GAAP營業利益率為52.6%。

In total, non-GAAP operating expenses increased 6% year-over-year to $11.9 billion as increased investment in both R&D and our launched products exceeded the benefits from our ongoing transformation initiatives. To put this in perspective, through the end of 2018, overall net operating expenses increased less than 1% on a 5-year CAGR as we reinvested our transformation savings to broaden our capabilities, launch multiple products in new therapeutic areas and generate innovative first-in-class molecules, including our emerging oncology programs. Other income and expenses were unfavorable by $410 million on a year-over-year basis due to lower interest income on our lower cash balances and portfolio rebalancing. The non-GAAP tax rate was 13.5% for the total year, down 4.5 points versus 2017 due to the impacts of U.S. corporate tax reform.

由於研發投入和已上市產品的增加超過了正在進行的轉型計畫帶來的收益，非GAAP營運總支出年增6%至119億美元。從這個角度來看，截至 2018 年底，由於我們將轉型節省的資金再投資於擴大自身能力、在新的治療領域推出多種產品以及開發創新的一流分子（包括我們新興的腫瘤項目），整體淨運營支出在 5 年複合年增長率中增長不到 1%。由於現金餘額減少導致利息收入下降以及投資組合重新平衡，其他收入和支出比去年同期減少了 4.1 億美元。全年非GAAP稅率為13.5%，比2017年下降4.5個百分點，這是由於美國企業稅制改革的影響。

Turning next to cash flow on the balance sheet on Page 9. For the full year 2018, Amgen continued to demonstrate strong and stable cash flow generation, reflecting a portfolio dominated by differentiated biologic products, coupled with an industry-competitive cost structure. 2018 free cash flow was $10.6 billion versus $10.5 billion in 2017. Debt outstanding at year-end totaled $33.9 billion and carries a weighted average interest rate of 4% and an average maturity of 11.5 years.

接下來，我們來看看資產負債表第 9 頁的現金流量。 2018 年全年，安進持續展現出強勁穩定的現金流，反映出其產品組合以差異化生物製品為主，並擁有業界具有競爭力的成本結構。2018 年自由現金流為 106 億美元，而 2017 年為 105 億美元。截至年末，未償債務總額為 339 億美元，加權平均利率為 4%，平均期限為 11.5 年。

In 2018, we returned a total of over $21 billion to shareholders, including deployment of $17.9 billion to repurchase 94.5 million shares at an average of $189 per share. Additionally, for 2018, we increased our dividend per share by 15% to $1.32 per quarter, with dividend payments totaling $3.5 billion. Based on our confidence in the future outlook for the enterprise and our continued commitment to a balanced capital allocation strategy, we also announced a 10% increase to the dividend to $1.45 per share for the first quarter of 2019.

2018 年，我們向股東返還了超過 210 億美元，其中包括斥資 179 億美元以平均每股 189 美元的價格回購了 9,450 萬股股票。此外，2018 年，我們將每股股利提高了 15%，達到每季 1.32 美元，股利支付總額為 35 億美元。基於我們對公司未來前景的信心，以及我們對平衡資本配置策略的持續承諾，我們也宣布將 2019 年第一季的股息提高 10%，至每股 1.45 美元。

Turning to the outlook for the business for 2019 on Page 10. 2019 will be another important year for Amgen as we continue investing in the pipeline, building out our global business and supporting our new product growth. In anticipation of this opportunity, we transformed the business over the past several years and, more recently, embedded a permanent productivity capability to enable us to fully invest from a position of strength. This business model enables us to deliver industry-leading financial performance while continuing to invest for long-term growth and success. Our 2019 revenue guidance is $21.8 billion to $22.9 billion, and our non-GAAP earnings per share guidance is $13.10 to $14.30 per share. Our non-GAAP tax rate guidance is 14% to 15%, and we expect capital expenditures of approximately $700 million this year.

接下來請看第 10 頁對 2019 年業務前景的展望。2019 年對安進來說將是另一個重要的年份，我們將繼續投資研發管線，拓展全球業務，並支持新產品的成長。為了抓住這一機遇，我們在過去幾年中對業務進行了轉型，最近又建立了永久性的生產力能力，使我們能夠從優勢地位出發進行全面投資。這種商業模式使我們能夠在持續投資以實現長期成長和成功的同時，實現領先業界的財務表現。我們對 2019 年的營收預期為 218 億美元至 229 億美元，非 GAAP 每股盈餘預期為 13.10 美元至 14.30 美元。我們預計今年的非GAAP稅率為14%至15%，資本支出約為7億美元。

There are several key assumptions embedded in our outlook that I will take a moment to share. First, our revenue guidance range reflects both continued, solid, positive growth momentum from our newer products as well as evolving competitive dynamics related to our mature products. We have important incremental growth opportunities, driven by recently launched products, including Aimovig, Repatha and biosimilars and international expansion as well as our emerging oncology programs. We also recognize the potential challenges, including further generic competition to Sensipar, continued competitive dynamics for Enbrel, and competition against Aranesp and Neulasta. With regard to net selling prices, as referenced, overall net selling price decreased by 1% in 2018. We expect net selling prices to decline by mid-single digits in 2019. Finally, we benefit from the added flexibility enabled by our transformation and productivity capabilities to use our strong cash flow and balance sheet to invest in the continued growth of the company.

我們的觀點包含幾個關鍵假設，我將花點時間分享。首先，我們的收入預期範圍既反映了我們新產品持續穩健的積極成長勢頭，也反映了我們成熟產品相關的不斷變化的競爭格局。我們擁有重要的增量成長機會，這得益於近期推出的產品（包括 Aimovig、Repatha 和生物類似藥）和國際擴張，以及我們正在開發的腫瘤學計畫。我們也意識到潛在的挑戰，包括Sensipar面臨的進一步仿製藥競爭、Enbrel持續的競爭動態，以及與Aranesp和Neulasta的競爭。關於淨售價，如前所述，2018 年整體淨售價下降了 1%。我們預計 2019 年淨售價將下降個位數百分比。最後，由於我們的轉型和生產力提升能力，我們擁有了更大的靈活性，可以利用我們強勁的現金流和資產負債表，投資於公司的持續發展。

With regard to Sensipar, we are confident in the strength of our intellectual property. However, uncertainty as to the timing and intensity of competition will remain until the outcome of litigation becomes clear. Our guidance reflects this uncertainty. Note that Sensipar sales will be lower than 2018 in all scenarios as the result of recent, short-lived generic entry, continued adoption of Parsabiv and a non-recurrence of the substantially higher purchases in Q1 of 2018 due to the reimbursement change from Part D to Part B.

關於Sensipar，我們對我們的智慧財產權實力充滿信心。然而，在訴訟結果明朗之前，競爭的時間和強度仍存在不確定性。我們的指導意見也反映了這種不確定性。請注意，由於近期短暫的仿製藥上市、Parsabiv 的持續普及以及由於報銷方式從 D 部分改為 B 部分導致 2018 年第一季度大幅增長的採購量不再出現，Sensipar 在所有情況下的銷售額都將低於 2018 年的銷售額。

As you recall, revenue in -- as you model revenue in 2019, note that historically, the first quarter represents the lowest product sales quarter of the year. As a percent of the full year, product sales for the first quarter should look similar to the percentage we saw in Q1 of 2018. Murdo will provide further details related to first quarter sales in his remarks. With respect to other revenue, we expect about $1.1 billion for the full year 2019, reflecting the nonrecurring nature of milestone payments received in 2018.

如您所記得，在對 2019 年的收入進行建模時，請注意，從歷史上看，第一季是一年中產品銷售額最低的季度。第一季產品銷售額佔全年銷售額的百分比應與 2018 年第一季的百分比相似。默多將在演講中提供有關第一季銷售情況的更多細節。至於其他收入，我們預計 2019 年全年約為 11 億美元，這反映了 2018 年收到的里程碑付款的非經常性質。

From an operating expense perspective, our transformation enabled us to establish a highly efficient cost profile. From this lean baseline, we expect to continue to generate incremental savings through our productivity improvement capability and manage cost in a very disciplined manner while making the investments required to rapidly advance our pipeline and maximize the value of our marketed products. Overall, we expect 2019 operating expense to be flat to down from 2018 on an absolute basis. We anticipate R&D expenses to rise as our pipeline advances; cost of sales to be flat to slightly up, depending on volume; and SG&A to decline as launch expenses normalize and we continue with a resource allocation discipline. Finally, we expect all categories to benefit from our productivity program.

從營運費用角度來看，我們的轉型使我們能夠建立高效的成本結構。在此精簡的基準基礎上，我們期望透過提高生產力能力繼續創造增量節省，並以非常嚴謹的方式控製成本，同時進行必要的投資，以快速推進我們的產品線並最大限度地提高我們已上市產品的價值。總體而言，我們預計 2019 年的營運支出將與 2018 年持平或略有下降（絕對值）。我們預期隨著產品線的推進，研發費用將會增加；銷售成本將維持不變或略有上升，取決於銷售量；隨著上市費用正常化以及我們持續維持資源分配紀律，銷售、管理及行政費用將會下降。最後，我們期望所有類別都能從我們的生產力提升計畫中受益。

With regard to our 2019 guidance, our non-GAAP tax rate is forecasted between 14% and 15%. This incorporates a 21% tax rate on U.S. earnings and a 10.5% tax rate on ex U.S. earnings.

關於我們 2019 年的業績指引，我們預計非 GAAP 稅率將在 14% 至 15% 之間。其中，美國境內收入適用 21% 的稅率，美國境外收入適用 10.5% 的稅率。

With regard to capital deployment, our actions will continue to reflect the following principles: First, we will invest in our business to expand our pipeline and seek to drive long-term revenue through volume growth globally in both large and specialty care markets. Second, we will remain committed to achieving an optimal capital structure in order to minimize our weighted average cost of capital by fully deploying cash flows over time as well as deploying excess accumulated capital. Reflecting our confidence in the future and remaining excess cash position, we will continue to support a growing dividend, including the 10% increase in the first quarter of 2019, as well as continued share repurchase in 2019 and beyond. At year-end 2018, we have a remaining unused board authorization to purchase up to $5.1 billion of our common stock.

在資本部署方面，我們的行動將繼續體現以下原則：首先，我們將投資於我們的業務，以擴大我們的產品線，並尋求透過在全球大型和專科護理市場實現銷售成長來推動長期收入。其次，我們將繼續致力於實現最佳資本結構，透過充分利用現金流量以及運用累積的超額資本，最大限度地降低加權平均資本成本。鑑於我們對未來的信心以及剩餘的充裕現金，我們將繼續支持不斷增長的股息，包括 2019 年第一季 10% 的成長，以及 2019 年及以後的持續股票回購。截至 2018 年底，我們還有剩餘的未使用的董事會授權，可以購買最多 51 億美元的普通股。

Finally, today's revenue and non-GAAP EPS guidance ranges are again wider than we have historically provided at the start of each year. This wide range is primarily a reflection of uncertainties related to our Sensipar sales, coupled with other ongoing uncertainties that I outlined earlier. Consistent with our usual practice, our guidance today does not include the impact of potential business development activities.

最後，今天公佈的營收和非GAAP每股收益預期範圍再次比我們往年年初公佈的範圍要寬。這一較大波動主要反映了我們 Sensipar 銷售的不確定性，以及我之前概述的其他持續存在的不確定性。與我們一貫的做法一致，我們今天的指導意見不包括潛在的業務發展活動的影響。

In summary, we delivered another year of strong financial results in 2018, and we remain confident in the outlook for Amgen's success in 2019 and beyond.

總而言之，我們在 2018 年又取得了強勁的財務業績，我們對安進在 2019 年及以後的成功前景仍然充滿信心。

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'll take a few minutes to reflect on our 2018 performance and then review our Q4 product-specific performance.

謝謝你，大衛。我將花幾分鐘時間回顧我們 2018 年的業績，然後回顧我們第四季的具體產品業績。

In 2018, we accomplished a great deal, growing sales 3%, driven by 5% volume growth. In the U.S., we launched 2 products: first, Aimovig, an innovative, first-in-class therapy for the prevention of migraine. Aimovig reached over 150,000 patients during 2018 and represents a strong launch trajectory. We also launched Parsabiv, which provides nephrologists with better control for their sHPT patients given its mode of administration. Parsabiv generated over $300 million of sales in the U.S. the first year of launch, again, representative of the benefit that it brings as well as Amgen's strength in nephrology.

2018年，我們取得了巨大的成就，銷售額成長了3%，這主要得益於銷量成長了5%。在美國，我們推出了兩款產品：首先是 Aimovig，這是一種創新的、同類首創的偏頭痛預防療法。Aimovig 在 2018 年惠及超過 15 萬名患者，展現出強勁的上市勢頭。我們也推出了 Parsabiv，由於其給藥方式，腎臟科醫生可以更好地控制 sHPT 患者的病情。Parsabiv 在美國上市第一年就創造了超過 3 億美元的銷售額，再次體現了該藥物帶來的益處以及安進在腎臟病學領域的實力。

We made great strides in driving volume growth across much of our portfolio. Take Prolia as an example. In the 8-plus years since launch, we delivered double-digit volume growth in every quarter. This illustrates the consistency and durability of growth opportunities in diseases with large, underserved patient populations. With Repatha, we've demonstrated our competitiveness with leading market shares while improving patient access and affordability. The fundamental characteristics of Repatha are similar to Prolia. Both address an asymptomatic disease with high numbers of undertreated patients. The physical, emotional and financial cost of events to patients and society, whether they'd be fractures in the case of Prolia or stroke or heart attacks in the case of Repatha, are exceedingly large. The patients at highest risk are identifiable and therapies, such as Prolia and Repatha, can prevent such outcomes.

我們在推動旗下大部分產品組合的銷售成長方面取得了巨大進展。以Prolia為例。自推出以來的 8 年多時間裡，我們每季都實現了兩位數的銷售成長。這說明，在患者群體龐大且服務不足的疾病領域，成長機會具有一致性和持久性。透過 Repatha，我們證明了我們在市場份額領先方面具有競爭力，同時提高了患者的用藥可及性和經濟承受能力。Repatha 的基本特徵與 Prolia 相似。兩者都針對大量未充分治療的無症狀疾病患者。無論是 Prolia 導致的骨折，還是 Repatha 導致的中風或心臟病發作，這些事件對患者和社會帶來的身體、情緒和經濟損失都非常巨大。可以識別出風險最高的患者，並且可以使用 Prolia 和 Repatha 等療法來預防此類後果。

Sales of our hematology and oncology portfolio of XGEVA, KYPROLIS, Vectibix, Nplate, BLINCYTO and IMLYGIC exceeded $4.4 billion, growing 14% over last year. This is a therapeutic area where we have strong global capabilities that we will leverage as our pipeline matures. While our mature brands of Enbrel, Neulasta, NEUPOGEN, EPOGEN and Aranesp face intensifying competition, our teams continue to promote and demonstrate the value that these brands provide. With decades of clinical experience and Amgen's assurance of high-quality supply, we expect these brands to continue to generate value for many years into the future.

我們的血液腫瘤產品組合（包括 XGEVA、KYPROLIS、Vectibix、Nplate、BLINCYTO 和 IMLYGIC）的銷售額超過 44 億美元，比去年增長了 14%。這是一個我們擁有強大全球實力的治療領域，隨著我們產品線的成熟，我們將充分利用這一優勢。儘管我們的成熟品牌 Enbrel、Neulasta、NEUPOGEN、EPOGEN 和 Aranesp 面臨日益激烈的競爭，但我們的團隊仍在繼續推廣和展示這些品牌所提供的價值。憑藉數十年的臨床經驗和安進公司對高品質供應的保證，我們預計這些品牌將在未來多年繼續創造價值。

Outside of the U.S., we launched our first 2 biosimilar products: KANJINTI, a biosimilar to Herceptin; and AMGEVITA, a biosimilar to Humira. We expect to launch additional biosimilars in 2019 across multiple geographies and continue to advance additional biosimilar assets through development. We remain confident in the biosimilar business opportunity that we embarked on nearly a decade ago and expect these assets to contribute significantly to Amgen's growth.

在美國以外，我們推出了首批 2 款生物相似藥產品：KANJINTI，一種赫賽汀的生物類似藥；以及 AMGEVITA，一種修美樂的生物類似藥。我們預計 2019 年在多個地區推出更多生物相似藥，並持續推動更多生物相似藥的研發。我們仍然對近十年前開始的生物相似藥業務機會充滿信心，並期望這些資產將為安進的成長做出重大貢獻。

Also, outside the U.S., where we faced biosimilar competition for many years, we had strong volume growth of 14% in 2018, demonstrating the growth potential of our newer portfolio. These markets serve as a model for Amgen's future growth profile. In addition, our ex U.S. business represents a growing portion of our overall revenue base due to our international expansion efforts.

此外，在美國以外，儘管我們多年來一直面臨生物相似藥的競爭，但我們在 2018 年實現了 14% 的強勁銷量成長，這表明我們較新的產品組合具有成長潛力。這些市場為安進未來的成長前景提供了參考模型。此外，由於我們積極拓展國際市場，美國以外的業務在我們整體收入基礎中所佔的比例越來越高。

Finally, we continue to invest in our portfolio, particularly those brands with longer periods of patent protection, including Enbrel, Prolia and Aimovig. Those investments have taken the form of evidence generation, patient-friendly devices and formulations, as well as consumer and health care provider awareness efforts. We are encouraged by the promotional responsiveness of these brands and continue to seek additional investment opportunities that can both drive volume growth and generate shareholder returns.

最後，我們將繼續投資於我們的產品組合，特別是那些專利保護期較長的品牌，包括 Enbrel、Prolia 和 Aimovig。這些投資體現在證據生成、對患者友善的設備和配方，以及提高消費者和醫療保健提供者意識等。我們對這些品牌的促銷回應感到鼓舞，並將繼續尋找能夠推動銷售成長和創造股東回報的額外投資機會。

Now moving to fourth quarter results. You'll find reference information on our product sales on Slides 12 and 13. Fourth quarter reported sales grew at 8% year-over-year, driven by 10% volume growth.

現在來看第四季業績。您可以在第 12 和 13 頁投影片中找到有關我們產品銷售的參考資訊。第四季報告銷售額年增 8%，主要得益於銷量成長 10%。

Let me start with Repatha on Slide 14. Q4 sales of Repatha grew by 62% year-over-year as we continue to compete effectively with a leading share in the PCSK9 class of approximately 60% globally. For the full year, Repatha grew by 72% with volume nearly doubling versus 2017. In 2018, we were able to secure improved payer utilization management criteria and help HCPs treat more patients. Additionally, we launched our new, lower list price Repatha, where we reduced the list price by 60%. We've seen strong uptake of this product, representing over 25% of all units in the U.S. as we exited the fourth quarter. To date, plans formally covering lower list price Repatha represent only 43% of Medicare lives. We're encouraging plans to move more rapidly to not only cover lower list price Repatha but also to provide coverage with low fixed co-pay given the significant potential benefit this can provide Medicare patients and to reduce their out-of-pocket costs. We look forward to working with the plans and the U.S. administration to see how we can get this important treatment to patients more rapidly. At a macro level, I'll remind you that the blended net price for Repatha in the U.S. will decline in 2019 as new contracts went into effect in January. While this lower net price may impact reported Repatha sales near term, we expect to see a positive impact on volume growth and reported net sales over the longer time frame. Regarding our ex U.S. business, we continue to work with country authorities to optimize access. Overall, our priority remains to help the large population of high-risk cardiovascular patients that can benefit from Repatha.

讓我們從第 14 張投影片上的 Repatha 開始。第四季 Repatha 的銷售額年增 62%，我們繼續有效競爭，在全球 PCSK9 類藥物中佔據約 60% 的領先份額。全年來看，Repatha 成長了 72%，銷量與 2017 年相比幾乎翻了一番。2018 年，我們成功爭取到更完善的支付方利用管理標準，並幫助醫療保健專業人員治療更多病患。此外，我們還推出了價格更低的新 Repatha，價格降低了 60%。我們看到該產品銷售強勁，截至第四季末，其在美國的銷售量佔比超過 25%。迄今為止，正式涵蓋低價 Repatha 的健保計劃僅涵蓋了 43% 的 Medicare 受保人。我們鼓勵加快推進相關計劃，不僅要涵蓋價格較低的Repatha，還要提供低固定共付額的保險，因為這可以為Medicare患者帶來巨大的潛在好處，並降低他們的自付費用。我們期待與相關機構和美國政府合作，探討如何更快為患者提供這種重要的治療。從宏觀層面來看，我要提醒大家，隨著新合約在 1 月生效，Repatha 在美國的綜合淨價將在 2019 年下降。雖然較低的淨價可能會在短期內影響 Repatha 的銷售額，但我們預計從長遠來看，這將對銷售成長和淨銷售額產生正面影響。關於我們在美國以外的業務，我們將繼續與各國​​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可以從瑞百安（Repatha）中受益的高風險心血管疾病患者。

On to Prolia on Slide 15. Prolia delivered another strong quarter with sales increasing 14% year-over-year, driven by 12% volume growth. As we typically see, we also had sequential growth in the fourth quarter. For the full year, Prolia grew 16%. Let me remind you that overall penetration is still in the mid-20% range across many markets, indicating significant potential for improved treatment. We expect Prolia will remain a very strong growth driver.

接下來是投影片 15 中的 Prolia。Prolia 又迎來了一個強勁的季度，銷售額年增 14%，其中銷量成長 12%。正如我們通常看到的那樣，第四季度我們也實現了環比成長。全年來看，Prolia 成長了 16%。我想提醒各位，目前許多市場的整體滲透率仍在 20% 左右，這表明治療效果還有很大的提升空間。我們預計Prolia將持續保持強勁的成長動力。

Moving to our hem/onc business. The portfolio of KYPROLIS, XGEVA, Nplate, Vectibix, BLINCYTO and IMLYGIC collectively totaled $1.1 billion in the quarter, growing 13% year-over-year. While there may be periodic quarterly fluctuations due to purchasing patterns, we expect this portfolio to continue as a growth engine and provide the foundation for both innovative and biosimilar additions to our oncology portfolio.

轉向我們的血液/腫瘤業務。KYPROLIS、XGEVA、Nplate、Vectibix、BLINCYTO 和 IMLYGIC 的投資組合在本季總計達到 11 億美元，較去年同期成長 13%。儘管由於採購模式的變化，可能會出現週期性的季度波動，但我們預計該產品組合將繼續作為成長引擎，並為我們的腫瘤產品組合增加創新藥物和生物相似藥奠定基礎。

Looking at additional details for some of the larger brands if we start with XGEVA on Slide 17. In Q4, XGEVA grew 17% year-over-year primarily from volume as we hold close to 60% share in the U.S. Our share in multiple myeloma patients continues to grow steadily with our label expansion in 2018. On a full year basis, XGEVA grew 13%.

如果我們從第 17 張投影片中的 XGEVA 開始，再來看看一些大品牌的更多細節。第四季度，XGEVA 年增 17%，主要得益於銷售成長，因為我們在美國的市佔率接近 60%。隨著 2018 年適應症的擴大，我們在多發性骨髓瘤患者中的份額繼續穩步增長。XGEVA 全年成長 13%。

On to KYPROLIS, which in Q4 grew 11% year-on-year, driven primarily by growth in markets outside of the U.S. Since its launch, KYPROLIS has delivered a suite of clinical evidence demonstrating its ability to meaningfully extend overall survival in patients with relapsed or refractory multiple myeloma. Our team continues to emphasize KYPROLIS overall survival benefit and we've seen new patient share gradually increase. Also, there are promising signs for our newly introduced, once-weekly administration with incremental growth in second-line usage of Kd. On a full year basis, KYPROLIS grew 16%.

接下來是 KYPROLIS，第四季年增 11%，主要得益於美國以外市場的成長。自上市以來，KYPROLIS 已提供了一系列臨床證據，證明其能夠顯著延長復發或難治性多發性骨髓瘤患者的總存活期。我們的團隊持續強調 KYPROLIS 的整體存活獲益，並且我們看到新患者的比例逐漸增加。此外，我們新推出的每週一次的給藥方式也顯示出良好的前景，Kd 的二線使用量正在逐步增長。KYPROLIS 全年成長 16%。

Let me also cover our filgrastim brands, starting on Slide 19. In Q4, Neulasta sales increased 5% year-over-year, which included a $55 million purchase from BARDA. For the full year 2018, Neulasta sales declined by 1%. As we anticipated, we now have 2 biosimilar competitors in the U.S., Facing one competitor during Q4, we retained 96% share of the long-acting market with Onpro, a majority share at over 60%. A second U.S. competitor was approved in late 2018 and it launched early this month. Our guidance anticipates the possibility for other competitors to enter the U.S. during 2019. In Europe, we now face 3 long-acting biosimilar competitors which have launched over the last 4 months and expect additional entrants during 2019. Consistent with our long-held expectations related to Europe with numerous competitors launching in a short time window, we expect European sales to decline over 25% year-over-year. More broadly, with the uncertainty over the eventual number of competitors on a global basis and their launch timing, there is a range of possible outcomes for Neulasta in 2019. We remain confident that our experience, established record of quality, dependable supply and innovative solutions, such as Onpro, will serve us well.

讓我再介紹一下我們的非格司亭品牌，從第 19 張投影片開始。第四季度，Neulasta 的銷售額年增 5%，其中包括從 BARDA 獲得的 5,500 萬美元的採購款。2018 年全年，Neulasta 的銷售額下降了 1%。正如我們預期的那樣，我們現在在美國有 2 個生物相似藥競爭對手。在第四季度面對一個競爭對手時，我們憑藉 Onpro 保持了長效藥市場 96% 的份額，佔據了超過 60% 的多數市場。第二款美國競爭對手於 2018 年底獲得批准，並於本月初上市。我們的預測預計，其他競爭對手可能會在 2019 年進入美國市場。在歐洲，我們現在面臨 3 家長效生物相似藥競爭對手，它們在過去 4 個月內已經上市，預計 2019 年還會有更多競爭者。與我們對歐洲市場的長期預期一致，由於眾多競爭對手將在短時間內推出產品，我們預計歐洲市場的銷售額將年減超過 25%。更廣泛地說，由於全球範圍內最終競爭對手的數量及其推出時間存在不確定性，Neulasta 在 2019 年可能會出現一系列不同的結果。我們仍然相信，我們的經驗、良好的品質記錄、可靠的供應和創新的解決方案（例如 Onpro）將為我們帶來良好的結果。

Turning to Slide 20. NEUPOGEN exited the fourth quarter with roughly 1/3 share of the short-acting segment in the U.S.

翻到第20張投影片。紐普根在第四季末佔據了美國短效止痛藥市場約 1/3 的份額。

Moving to Enbrel. For both Q4 and the full year, sales declined 8%, primarily driven by volume and net selling price declines. In general, we expect recent trends to continue. Recall that the first quarter represents the lowest sales of the year due to insurance reverifications and resetting of deductibles and channel inventory fluctuations. As a percent of the full year, the first quarter should look similar to 2018.

改用恩利（Enbrel）。第四季和全年銷售額均下降了 8%，主要原因是銷量和淨售價下降。總體而言，我們預計近期的趨勢將會持續。請記住，由於保險重新核實、免賠額重置和通路庫存波動，第一季是一年中銷售額最低的季度。佔全年百分比來看，第一季的情況應該與 2018 年類似。

Switching to nephrology, starting on Slide 22. Q4 EPOGEN sales declined 2% due to lower net selling price and the category is becoming increasingly competitive. For the full year 2018, sales declined by 8%. With the launch of a biosimilar competitor late last year and our contractual pricing commitments with DaVita, the net price decline for EPOGEN will increase significantly in 2019 and is already in effect.

接下來轉到腎臟病學部分，從第 22 張投影片開始。第四季 EPOGEN 銷售額下降 2%，原因是淨售價降低，而且該品類競爭日益激烈。2018 年全年，銷售額下降了 8%。隨著去年底生物相似藥競爭對手的上市以及我們與 DaVita 簽訂的合約定價承諾，EPOGEN 的淨價格下降幅度將在 2019 年大幅增加，並且已經生效。

Aranesp declined 3% year-over-year in Q4, primarily driven by increased competition from a long-acting product in the independent and midsize dialysis organizations. For the full year, Aranesp declined 9%. Recall that the short-acting biosimilar is approved to compete in all market segments in the U.S. As referenced, Slide 24 shows the breakout by segment of our ESA business. We expect sales to decline at a faster rate in 2019 than 2018 with both long-acting and short-acting competition in the U.S.

第四季度，Aranesp 的銷售量年減了 3%，主要原因是獨立和中型透析機構中長效產品的競爭加劇。全年來看，Aranesp 下降了 9%。請記住，短效生物相似藥已獲准在美國所有市場領域競爭。如參考資料所示，第 24 張投影片顯示了我們 ESA 業務按細分市場劃分的情況。我們預計，由於美國市場存在長效和短效藥物的競爭，2019 年的銷售額下降速度將比 2018 年更快。

With regards to calcimimetics, we continue to see strong utilization of Parsabiv at independent and midsize dialysis providers who have incorporated it into their protocols. However, the rate of adoption with those customers slowed in Q4 as Parsabiv already represented a majority of calcimimetic utilization for their patients. We continue to see gradual adoption of Parsabiv with FMC and DaVita and expect most of the future growth to come from these customers.

關於擬鈣劑，我們繼續看到獨立和中型透析服務提供者大量使用帕沙比夫，並將其納入他們的治療方案中。然而，由於 Parsabiv 已佔據了這些患者鈣敏感受體激動劑使用的大部分份額，因此第四季度這些客戶的採用率有所放緩。我們看到 FMC 和 DaVita 等客戶逐漸採用 Parsabiv，預計未來大部分成長將來自這些客戶。

Turning to Sensipar. The outlook remains uncertain given ongoing litigation leading to a range of possible outcomes, and you heard David characterize our guidance related to Sensipar. Let me reiterate the points that he made. Recall that Q1 of 2018 had substantially higher purchases than normal run rates due to the reimbursement change from Part D to Part B. Also, looking forward, there will be volume erosion due to continued Parsabiv uptake. And finally, the short-lived generic entry will impact 2019 sales. Regarding 2018 performance, Q4 sales increased 8%, primarily driven by changes in accounting estimates, offset by lower volume due to the continued adoption of Parsabiv. Sales grew 3% on a full year basis.

改用Sensipar。鑑於持續的訴訟可能導致各種不同的結果，前景仍然不明朗，你們也聽到了 David 對我們關於 Sensipar 的指導意見的描述。讓我重申他提出的觀點。需要注意的是，由於健保報銷範圍從D部分變更為B部分，2018年第一季的採購量遠高於正常水準。此外，展望未來，由於Parsabiv的持續普及，採購量將會下滑。最後，短暫上市的仿製藥將對 2019 年的銷售額產生影響。2018 年業績方面，第四季銷售額成長 8%，主要得益於會計估計的變化，但由於 Parsabiv 的持續普及，銷量下降，抵消了這一增長。全年銷售額成長3%。

Shifting gears from our innovative products to our biosimilars portfolio. Our European launches for KANJINTI and AMGEVITA are underway. While still early in the launch cycle, the market is playing out as we anticipated and we're pleased with our performance to date. Outside of the U.S., we see important differences between products and markets in terms of biosimilar uptake and price erosion. Recent launches in markets such as Norway and the Netherlands are experiencing strong uptake at more discounted pricing levels, while in other larger markets, including Germany and France, there's a more balanced dynamic and sustainable opportunity. Our strategy is to focus primarily on these more sustainable markets, which we expect will drive our biosimilar revenues in the next several years. We also expect incremental contribution from competing selectively in certain tender-driven markets. Across Europe, there is significant demand for high-quality, reliable biosimilars. While some have speculated as to the strength of the biosimilar market in the U.S., we see biosimilars representing an important market for the future, using NEUPOGEN as an example where biosimilars continue to gain share, demonstrating that they can successfully compete in the U.S. market. We're planning for additional launches in 2019 and expect this business to be a growth driver for years to come.

我們將工作重點從創新產品轉向生物相似藥產品組合。KANJINTI 和 AMGEVITA 在歐洲的上市計劃正在進行中。雖然產品仍處於上市初期，但市場發展正如我們所預期的那樣，我們對迄今為止的業績感到滿意。在美國以外，我們在生物相似藥的接受度和價格侵蝕方面，看到不同產品和市場之間存在重要差異。最近在挪威和荷蘭等市場推出的產品，在折扣價水平下獲得了強勁的市場反響；而在德國和法國等其他更大的市場，則呈現出更加平衡的動態和可持續的發展機會。我們的策略是主要專注於這些更永續的市場，我們預計這些市場將在未來幾年推動我們的生物相似藥收入成長。我們也期望透過在某些以招標為主導的市場中進行選擇性競爭來獲得增量貢獻。在整個歐洲，對高品質、可靠的生物相似藥的需求量很大。儘管有人對美國生物相似藥市場的實力進行了猜測，但我們認為生物相似藥代表著未來一個重要的市場，以 NEUPOGEN 為例，生物相似藥不斷擴大市場份額，這表明它們可以在美國市場成功競爭。我們計劃在 2019 年推出更多產品，並預計這項業務將在未來幾年成為成長動力。

I'd like to close the product review section of my comments with Aimovig. We continue to be excited by the strong response from physician and patient community following the launch of this innovative therapy. Overall, the CGRP market grew at over 150% quarter-over-quarter in Q4, with Aimovig exiting 2018 with the majority share, demonstrating our first-mover advantage, strong product profile and ability to compete. We recently launched our DTC campaign and see early promising results. I know there's been a great deal of interest in the number of prescriptions that are being paid for, so let me share that. During Q4, the percentage paid was 50%, which was up from prior quarter at 35%. We also expect to double contracted coverage in Q1 versus Q4. Before closing on Aimovig comments, I should call out that the fourth quarter sales of $95 million benefited from $20 million of changes in prior period accounting estimates as we realized higher average net selling prices from quarters 2 and 3 versus our prior estimates. And like Enbrel, the first quarter for Aimovig will also experience insurance reverifications and resetting of deductibles, leading it to be a lower quarter than subsequent ones. We expect Aimovig to continue to be a growth driver for Amgen.

我想以Aimovig的產品評價來結束我的評論部分。這項創新療法推出後，受到了醫生和患者群體的熱烈反響，我們對此感到非常振奮。總體而言，CGRP 市場在第四季度環比增長超過 150%，Aimovig 在 2018 年結束時佔據了大部分市場份額，證明了我們的先發優勢、強大的產品組合和競爭能力。我們最近啟動了DTC行銷活動，並已看到初步的良好效果。我知道大家對健保報銷的處方數量非常感興趣，所以讓我來分享一下。第四季支付比例為 50%，高於上一季的 35%。我們也預計第一季的合約覆蓋範圍將比第四季翻一番。在結束對 Aimovig 的評論之前，我應該指出，第四季度 9500 萬美元的銷售額得益於前期會計估計的 2000 萬美元變化，因為我們實現了比之前估計更高的第二季度和第三季度平均淨售價。與 Enbrel 一樣，Aimovig 的第一季也將經歷保險重新核實和免賠額重置，導致其業績低於後續季度。我們預計 Aimovig 將繼續成為安進的成長動力。

In summary, we continue to market a portfolio exemplified by important medicines that treat serious diseases. I'm pleased with the execution and consistency of performance in 2018, demonstrating that we have established a strong foundation for the future. Our portfolio will continue to evolve during 2019, and we're prepared to maximize on the opportunities to bring Amgen's products to a greater number of patients.

總而言之，我們繼續銷售一系列產品，其中包括治療嚴重疾病的重要藥物。我對 2018 年的執行情況和業績穩定性感到滿意，這表明我們已經為未來奠定了堅實的基礎。2019年，我們的產品組合將繼續發展，我們已做好準備，最大限度地抓住機遇，將安進的產品帶給更多患者。

Now I'd like to turn the call over to Dave Reese.

現在我想把電話交給戴夫·里斯。

Thanks, Murdo. As we enter 2019, I've never felt better about our effort, progress and productivity in R&D. Our investment in human genetics continues, powered by deCODE and their work on the Icelandic population, more than 1 million participants from outside Iceland and, in the future, up to an additional 0.5 million patients following our agreement with a leading U.S. integrated delivery network. Today, over 75% of our pipeline has some degree of human genetic validation compared to just 15% 5 years ago. This increases the conviction we have in certain programs and gives us the confidence to make more aggressive strategic investment from discovery through clinical development that can improve cycle time significantly. In fact, through our use of genetics and our transformation efforts, we estimate that we have reduced the development time lines in some of our programs by an average of 3 years. To complement our human genetics work, we are partnering with SomaLogic to analyze 5,000 proteins in up to 40,000 individuals for whom sequencing data are available. To our knowledge, this is the largest proteomics experiment ever conducted and may enhance our insights into disease biology.

謝謝你，默多。進入 2019 年，我對我們在研發方面的努力、進展和效率從未感到如此滿意。在 deCODE 及其對冰島人口的研究工作的支持下，我們對人類遺傳學的投資仍在繼續，此外還有來自冰島以外的 100 多萬名參與者，未來，根據我們與美國領先的綜合醫療服務網絡達成的協議，還將有多達 50 萬名患者參與研究。如今，我們研發管線中超過 75% 的產品都經過了一定程度的人類基因驗證，而 5 年前這一比例僅為 15%。這增強了我們對某些項目的信心，也讓我們有信心從發現到臨床開發進行更積極的策略投資，從而顯著縮短週期時間。事實上，透過我們對遺傳學的運用和改造努力，我們估計，我們一些計畫的開發時間平均縮短了 3 年。為了補充我們的人類遺傳學工作，我們正在與 SomaLogic 合作，分析多達 40,000 名有定序數據的個體的 5,000 種蛋白質。據我們所知，這是迄今為止規模最大的蛋白質體學實驗，可能會加深我們對疾病生物學的理解。

R&D is firing on all cylinders as we have advanced a record number of programs. One of our key productivity metrics is the number of molecules we commit to take forward into human testing, the formation of so-called product teams. I am pleased to report that over the last 2 years, we formed more product teams than any prior 2 years in Amgen's history. In the same period, we also filed 20 INDs, approximately 70% of these being first-in-class molecules, and we also began 15 first-in-human clinical studies. Several of these will begin reading out this year.

研發工作全面展開，我們所推動的專案數量創下歷史新高。我們的關鍵生產力指標之一是我們承諾推進人體試驗的分子數量，也就是所謂的「產品團隊」的組成數量。我很高興地報告，在過去的兩年裡，我們組建的產品團隊數量超過了安進歷史上任何兩​​年。在同一時期，我們也提交了 20 份 IND 申請，其中約 70% 為同類首創分子，並且我們也啟動了 15 項首次人體臨床研究。其中一些將於今年開始播出。

I'll begin with an update on oncology. In December, we had the opportunity at ASH to present the initial clinical data from our BCMA BiTE, AMG 420 in multiple myeloma and our CD33 BiTE, AMG 330 in AML. The data were very well received by the medical community, most notably the AMG 420 data, which demonstrated a 70% response rate and a 40% MRD-negative complete response rate at our target dose in heavily pretreated patients. We look forward to additional data from those programs this year, along with initial data from our half-life extended BiTE programs, AMG 701 directed against BCMA and potentially AMG 673 directed against CD33.

我先來報告腫瘤學的最新進展。去年 12 月，我們有機會在 ASH 大會上展示了我們的 BCMA BiTE（AMG 420）在多發性骨髓瘤中的初步臨床數據，以及我們的 CD33 BiTE（AMG 330）在急性髓性白血病中的初步臨床數據。這些數據受到了醫學界的熱烈歡迎，尤其是 AMG 420 的數據，該數據表明，在接受過大量預治療的患者中，我們的目標劑量達到了 70% 的緩解率和 40% 的 MRD 陰性完全緩解率。我們期待今年能從這些項目中獲得更多數據，以及我們延長半衰期的 BiTE 項目（針對 BCMA 的 AMG 701 和可能針對 CD33 的 AMG 673）的初步數據。

We also expect initial data from our small molecule, KRAS G12C inhibitor, AMG 510 in the first half of the year. This particular mutation is easily identifiable and present in about 15% to 25% of lung adenocarcinomas and 2% to 4% of a wide range of other solid tumors, including pancreatic cancer and colorectal cancer. This is an example of a program that we accelerated significantly. We were the first into the clinic and are now moving through dose escalation, where we are seeing interesting early hints of clinical activity.

我們也預計將在今年上半年獲得我們的小分子 KRAS G12C 抑制劑 AMG 510 的初步數據。這種特殊的突變很容易識別，在約 15% 至 25% 的肺腺癌和 2% 至 4% 的其他各種實體瘤（包括胰腺癌和結直腸癌）中存在。這是一個我們大幅加速推進的專案的例子。我們是第一個進入臨床試驗的，現在正在進行劑量遞增試驗，我們已經看到了一些有趣的早期臨床療效跡象。

We also expect data from our MCL-1 inhibitor program in multiple myeloma and AML from both our IV and oral formulations, AMG 176 and AMG 397, respectively. Our preclinical data suggests that these molecules could be additive or synergistic with a BCL-2 inhibitor, and we will be advancing combination studies as we move forward.

我們也期待獲得 MCL-1 抑制劑計畫在多發性骨髓瘤和 AML 的數據，包括我們的靜脈注射製劑 AMG 176 和口服製劑 AMG 397。我們的臨床前數據表明，這些分子可能與 BCL-2 抑制劑具有疊加或協同作用，我們將推進聯合研究。

We also expect data this year from AMG 596, a first-generation EGFRvIII BiTE under investigation in patients with glioblastoma, a setting where a short half-life molecule is preferable due to potential on-target toxicity within the CNS. This mutation is present in about 25% of glioblastomas and represents a true tumor-specific antigen.

我們也期待今年能獲得 AMG 596 的數據，這是一種正在膠質母細胞瘤患者中進行研究的第一代 EGFRvIII BiTE，由於中樞神經系統內潛在的靶向毒性，短半衰期分子在膠質母細胞瘤治療中更受歡迎。這種突變存在於約 25% 的膠質母細胞瘤中，代表了一種真正的腫瘤特異性抗原。

We're also pleased to report that a single-arm Phase III trial of KYPROLIS and dexamethasone, Kd, met its response rate primary end point in China in patients with relapsed and refractory multiple myeloma. Finally in the oncology pipeline, later this year, we expect to conduct a primary analysis of our Phase III study of KYPROLIS in combination with dexamethasone and Darzalex, Kd dara, versus Kd alone in relapsed or refractory myeloma.

我們也很高興地報告，KYPROLIS 和地塞米松 (Kd) 在中國進行的單臂 III 期試驗達到了其主要終點，該試驗針對複發和難治性多發性骨髓瘤患者。最後，在腫瘤治療產品線方面，我們預計今年稍後對 KYPROLIS 聯合地塞米松和達雷妥尤單抗 (Kd dara) 與單獨使用 Kd 治療復發或難治性多發性骨髓瘤的 III 期研究進行主要分析。

In cardiovascular, the Repatha indication was recently expanded in China, making it the first PCSK9 inhibitor approved there to reduce the risk of myocardial infarction, stroke and coronary revascularization in adults with established atherosclerotic cardiovascular disease. In our other atherosclerosis clinical program, we are impressed with the initial clinical data we're seeing with AMG 890 and siRNA that targets Lp(a), high levels of which are genetically determined and associated with an increased risk of cardiovascular disease. We look forward to sharing those data with you later this year or in early 2020.

在心血管領域，瑞百安（Repatha）最近在中國擴大了適應症，成為首個在中國獲批的PCSK9抑制劑，用於降低已確診動脈粥狀硬化性心血管疾病的成年人發生心肌梗塞、中風和冠狀動脈血運重建的風險。在我們另一個動脈粥狀硬化臨床計畫中，我們對 AMG 890 和靶向 Lp(a) 的 siRNA 的初步臨床數據印象深刻，Lp(a) 的高水平是由基因決定的，並且與心血管疾病風險增加有關。我們期待在今年稍後或 2020 年初與您分享這些數據。

In bone, EVENITY was recently approved in Japan for the treatment of osteoporosis patients at high risk for fracture, and we were pleased that the FDA Advisory Committee voted in favor of approval for the treatment of postmenopausal women with osteoporosis at high risk for fracture in the United States. We will continue working with FDA towards registration and, along with our partner, UCB, look forward to bringing this effective medicine to osteoporosis patients at high risk for fracture in the U.S. and around the world.

在骨骼方面，EVENITY 最近在日本獲準用於治療骨折風險高的骨質疏鬆症患者，我們很高興 FDA 諮詢委員會投票贊成批准其在美國用於治療骨折風險高的停經後骨質疏鬆症婦女。我們將繼續與 FDA 合作，爭取獲得註冊，並與我們的合作夥伴 UCB 一起，期待將這種有效的藥物帶給美國和世界各地有骨折高風險的骨質疏鬆症患者。

Finally, we continued to advance our biosimilar programs with regulatory submissions completed in the U.S. and EU for ABP 710, our biosimilar REMICADE. On December 28, we refiled our BLA with the FDA for KANJINTI, our biosimilar Herceptin, and expect a 6-month review. ABP 798, our biosimilar Rituxan, met all of its primary and secondary end points in a Phase III trial in patients with rheumatoid arthritis, and we anticipate the completion of a second Phase III trial in non-Hodgkin's lymphoma later this year. We have also begun screening patients in the Phase III study of ABP 959, our biosimilar Soliris. Bob?

最後，我們繼續推動生物相似藥項目，完成了美國和歐盟針對 ABP 710（我們的生物相似藥 REMICADE）的監管申報。12 月 28 日，我們向 FDA 重新提交了 KANJINTI（我們的赫賽汀生物類似藥）的生物製品許可申請 (BLA)，預計將進行 6 個月的審查。我們的生物相似藥利妥昔單抗（Rituxan）ABP 798 在類風濕性關節炎患者的 III 期試驗中達到了所有主要和次要終點，我們預計將於今年稍後完成針對非何杰金氏淋巴瘤的第二項 III 期試驗。我們也已開始對 ABP 959（我們的生物相似藥 Soliris）的 III 期研究的患者進行篩選。鮑伯？

Okay. Thank you. We've covered a lot of ground now. Ian, why don't we open up the line to questions? And if you wouldn't mind, please remind the callers what the process is for asking questions.

好的。謝謝。我們現在已經討論了很多內容。伊恩，我們為什麼不開放提問環節呢？如果您不介意的話，請提醒一下來電者提問的流程是什麼。

(Operator Instructions) And our first question is from the line of Ying Huang from Bank of America Merrill Lynch.

（操作員說明）我們的第一個問題來自美國銀行美林證券的黃穎女士。

First question I have is regarding your assumption for Neulasta in the guidance. Are you assuming there will be a third entry for Neulasta biosimilar? And then are you also assuming the net price similar -- in terms of decline, similar to the 2018 or not? And then next question is, if you don't consummate a big M&A transaction, would you consider another ASR this year in 2019?

我的第一個問題是關於您在指南中對 Neulasta 的假設。您認為會有第三款Neulasta生物相似藥上市？那麼，您是否也假設淨價下跌幅度與 2018 年類似？那麼下一個問題是，如果您沒有完成大型併購交易，您是否會考慮在 2019 年再次進行 ASR 收購？

Okay. There's a couple of questions there. First, on Neulasta, I think both Murdo and David addressed this. Murdo, do you want to reiterate what you said on the call?

好的。這裡有幾個問題。首先，關於 Neulasta，我認為 Murdo 和 David 都談到了這一點。默多，你想重申一下你在電話裡說過的話嗎？

Yes, sure. On Neulasta, we're assuming that we will have, as expected, the 2 competitors in the market as well as potential additional competitors before the end of 2019 in the U.S. We're also assuming some additional competition outside the U.S.

當然可以。關於 Neulasta，我們假設，正如預期的那樣，到 2019 年底，美國市場上將出現 2 個競爭對手，以及潛在的其他競爭對手。我們也假設，美國以外地區也會有一些額外的競爭。

David, do you want to just...

大衛，你只想…

Yes, sure.

當然可以。

On the guidance more broadly?

關於更廣泛的指導意見？

Yes, yes. In terms of the capital and cash deployment, of course, our priorities are the same, which is our first priority is to invest in the business both internally at Amgen as well as looking very actively at potential additions to the portfolio through business development. And obviously, we have plenty of financial flexibility to be able to accomplish that. We're also committed to return excess cash to shareholders through time. And I would observe that we had quite significant returns to shareholders last year, over $21 billion. And I would say from a repurchase perspective, I would look at the pace at which we've been operating as a reasonable guide for us into '19. And then more specifically as to the ASR question, we haven't made a determination as to whether we'd pursue something of that sort, but obviously, if we decided to, we'd be communicating that.

是的，是的。在資本和現金部署方面，我們的優先事項當然是一樣的，那就是我們的首要任務是投資於業務，既包括安進內部的投資，也包括透過業務拓展積極尋找潛在的投資組合成長點。顯然，我們有足夠的財務靈活性來實現這一點。我們也承諾不時將多餘的現金回饋給股東。我注意到，去年我們為股東帶來了相當可觀的回報，超過 210 億美元。從回購的角度來看，我認為我們目前的營運速度可以作為 2019 年的合理參考。至於 ASR 問題，我們還沒有決定是否會推進此類項目，但顯然，如果我們決定推進，我們會對外公佈。

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。

So 2 questions from me just related to guidance as well. Can you just help us -- I'm still not clear to how much inventory Teva launched in the channel for Sensipar. Can you just tell us how much of a headwind that's expected to be for Sensipar this year? And then on EPOGEN and, I guess, Aranesp as well, you talked about significant year-over-year price decline. Can you help us with order of magnitude, these single or double-digit year-over-year kind of price declines for those products?

所以，我還有兩個問題，也跟指導有關。您能幫我們一下嗎？我仍然不清楚Teva在渠道中為Sensipar推出了多少庫存。可以告訴我們一下，今年Sensipar預計會面臨多大的阻力嗎？然後，關於 EPOGEN，我想還有 Aranesp，您也談到了價格同比大幅下降的情況。您能否幫我們估算一下這些產品年減的幅度，例如個位數或兩位數的降幅？

Yes. So maybe I'd start on the Sensipar question. And I guess what I'd say, first of all, in all scenarios that we've got for Sensipar in '19, as I said, we do expect a year-over-year decline in sales driven by the Part D to B switch last year, Parsabiv taking more share of the market, and the fact that there was the temporary entrant of a generic competitor. What's true is our agreement does not allow us to comment on the amount of product put into the market, but what I would say is we did indicate that if you look at our overall sales in the first quarter, we think as a percent of the total year, they'll be comparable to 2018. And I think it's fair to assume that the impact on the market from the Sensipar generic was likely to be certainly impacting Q1.

是的。所以或許我可以先從Sensipar的問題著手。首先，我想說的是，就我們目前對 Sensipar 在 2019 年的各種預測而言，正如我所說，我們預計銷售額將同比下降，這主要是由於去年 D 部分轉為 B 部分、Parsabiv 佔據了更大的市場份額，以及仿製藥競爭對手的暫時進入市場。事實是，我們的協議不允許我們評論投放市場的產品數量，但我可以肯定的是，我們已經表示，如果你看一下我們第一季的整體銷售額，我們認為佔全年總額的百分比將與 2018 年相當。我認為可以合理推斷，Sensipar仿製藥對市場的影響很可能肯定會對第一季產生影響。

Yes. Matthew, we're expecting trends to be fairly stable in our Aranesp and our EPOGEN business going forward.

是的。馬修，我們預期未來Aranesp和EPOGEN業務的發展趨勢將相當穩定。

(Operator Instructions) And our next question is from the line of Chris Raymond from Piper Jaffray.

（操作說明）我們的下一個問題來自 Piper Jaffray 公司的 Chris Raymond。

Maybe just a Repatha question. Murdo, I just want to make sure I understand what you're talking about with respect to net price. I think when you guys announced the new pricing structure and the new SKU, you took pains to say that -- not to expect a change in the blended net price going forward, but I look at Slide 14. It looks like you're guiding to a lower net price. So is that sort of a long-term data point? Or is there something else going on there? And then maybe just a part 2 to that question. Just kind of curious, you've mentioned 12 to 18 months to get folks to migrate to that lower-priced SKU. I'm just kind of curious how that conversation goes with payers who continue to opt for the higher-priced SKU.

或許只是關於瑞百莎（Repatha）的問題。Murdo，我只是想確認一下我是否理解你說的淨價是什麼意思。我認為，當你們宣布新的定價結構和新的 SKU 時，你們特意強調——不要指望未來的綜合淨價會發生變化，但我看了第 14 張幻燈片。看起來你是在引導用戶選擇更低的淨價。所以這算是一種長期數據點嗎？或者，那裡還有其他事情發生？然後或許可以再補充一部分這個問題。我只是有點好奇，你提到需要 12 到 18 個月的時間讓人們遷移到價格較低的 SKU。我只是有點好奇，對於那些繼續選擇價格較高的 SKU 的付款方來說，這種對話會如何進行。

Yes, thanks for the question. The -- overall, the experience with Repatha has been very good through the fourth quarter, and we're optimistic that we'll continue to make good inroads this year. If you recall, we were contracting through the middle of last year to improve utilization management criteria for Repatha and we've been competitively doing that. In addition, with the introduction of the new low list price, we were able to directly address the out-of-pocket expenses for some Medicare Part D patients. What we're signaling is that we will have some step down in net ASP with new contracts going into effect in 2019. However, we do expect that, that will be offset with volume growth throughout the course of the year. The other thing that I would point out, just to your question on how those conversations go, is we did launch the low list price Repatha late in the bid-cycle for Medicare Part D plans for payers at the end of last year. So we weren't expecting to be broadly used and listed on their formularies in the first part of this year. So we're working for off-cycle additions and we've been able to do that. And we've been able to drive about 25% of our movement as the low list price of Repatha, and that continues to climb. And we've been able to see some out-of-pocket costs being reduced at the counter for Medicare Part D patients who need access to this medicine. I would say it's going according to plan, but we are doing everything we can to work with payers to accelerate that.

是的，謝謝你的提問。總的來說，第四季與 Repatha 的合作體驗非常好，我們樂觀地認為今年我們將繼續取得良好進展。如果你還記得的話，我們去年年中一直在與 Repatha 公司簽訂合同，以改進其利用管理標準，而且我們一直在積極爭取這樣的成果。此外，隨著新的低價標價的推出，我們能夠直接解決一些 Medicare Part D 患者的自付費用問題。我們發出的信號是，隨著2019年新合約的生效，淨平均售價將會下降。不過，我們預計，全年銷售成長將抵銷這一影響。關於您提出的那些對話是如何進行的這個問題，我想指出的另一點是，我們在去年年底醫療保險D部分計劃的競標週期後期推出了低價的Repatha。因此，我們並沒有期望在今年上半年就被廣泛使用並列入他們的藥品目錄。所以我們正在努力進行非週期性擴建，而且我們已經成功地做到了這一點。我們已經能夠將大約 25% 的銷售量轉化為 Repatha 的低價，而且這個價格還在持續攀升。我們已經看到，對於需要獲得這種藥物的 Medicare Part D 患者來說，他們在藥房櫃檯的自付費用有所降低。我認為一切都在按計劃進行，但我們正在盡一切努力與支付方合作，加快這一進程。

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

下一個問題來自高盛的 Terence Flynn。

I was just wondering, with respect to Aimovig, if you can give us any update there on the formulary dynamics in terms of where you stand, how many decisions are outstanding. Any key differences versus Repatha as we think about the longer-term pricing outlook there? And then would love an update on the monthly formulation in terms of when we might expect that to launch.

我只是想問一下，關於Aimovig，您能否給我們提供一下關於藥品目錄動態的最新情況，例如您目前的立場，還有多少決定尚未做出。從長遠價格前景來看，Repatha 與該品牌有哪些關鍵差異？此外，我們也希望了解每月配方更新情況，例如預計何時推出。

Yes. I'll handle the first part and then maybe turn over to Dave Reese for the change in formulation. Overall, we're really pleased with Aimovig. We priced this product for access. It's been well received by payers for the most part. What's happened to date has been that we've received pretty good coverage with most payers even on an un-contracted basis, allowing the product to be reimbursed on the basis of physician attestation alone. What we are seeing now into the first quarter is an increase in the number of paid prescriptions. So that jumped from 35% to about half of our total prescriptions in the fourth quarter. What we will see though is from Q4 to Q1 is we will see an increase in our contracted business, and that will have a short-term step-down in net selling price. But then as the year progresses, we should stabilize because we'll have a smaller and smaller percentage of our business that is through free goods program versus contracted, paid for.

是的。第一部分我來處理，然後配方修改的部分可能交給戴夫·里斯。總的來說，我們對Aimovig非常滿意。我們為這款產品定價是為了方便用戶使用。總體而言，它受到了付款方的好評。到目前為止，我們已經從大多數支付方獲得了相當不錯的報銷，即使在沒有合約的情況下，也允許僅憑醫生證明即可報銷該產品。我們現在在第一季看到的是付費處方數量的增加。因此，第四季該比例從 35% 躍升至我們總處方量的大約一半。不過，從第四季度到第一季度，我們將看到合約業務增加，這將導致淨售價短期下降。但隨著時間的推移，情況應該會趨於穩定，因為我們透過免費商品計畫獲得的業務比例會越來越小，而透過合約約定、付費的方式獲得的業務比例則會越來越小。

And on the question, Terence, of when we're going to -- when we expect to hear from FDA...

至於特倫斯提出的問題，我們什麼時候才能收到FDA的訊息…

Yes, I mean, we've -- this is Dave Reese. We've submitted that. It's under FDA review. We'll provide guidance as those discussions are moved further along with the agency.

是的，我的意思是，我們有——這位是戴夫·里斯。我們已經提交了。目前正在接受美國食品藥物管理局（FDA）的審查。我們將根據相關機構的進展提供指導。

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

下一個問題來自巴克萊銀行的傑弗裡·米查姆。

A question for Dave on the oncology pipeline. There's a lot to digest on Slide 30 and you've got a lot of programs. I don't think this includes your recent IO collaboration. So the question, how do you prioritize? And more importantly, when you look at trying to fill the revenue gap from biosimilars, are there oncology programs that you'd call out that are closer to starting at Phase III?

關於腫瘤治療研發管線，我有個問題想問Dave。第 30 張投影片上有很多內容需要消化，而且有很多程式需要講解。我認為這不包括你最近在IO領域的合作。所以問題來了，你如何確定優先順序？更重要的是，在考慮如何填補生物相似藥的收入缺口時，您認為有哪些腫瘤治療計畫更接近進入 III 期臨床試驗？

Sure. So I think you raised an important question about how we prioritize. That's really based on emerging data. As we developed a broad-based plan to advance these agents, we went through a detailed prioritization exercise. And we would expect that over the course of the year, there will be puts and takes based on emerging data and we fully intend to invest resources behind those programs that are showing evidence of efficacy, the kind of transformative efficacy that we're aiming for.

當然。所以我覺得你提出了一個關於我們如何確定優先事項的重要問題。這確實是根據新出現的數據得出的結論。在製定推進這些代理人的全面計劃時，我們進行了詳細的優先排序工作。我們預計，在這一年中，將根據新出現的數據進行投入和調整，我們將全力投入資源支持那些顯示出有效性的項目，也就是我們所追求的那種變革性有效性。

In terms of those programs that may be closer to Phase III, that's a little harder to speculate on. I think the KRAS program, the MCL-1 programs and some of the BiTEs in the -- BCMA BiTEs in the early portfolio can transition to potential registration quality trials. I wouldn't necessarily use the Phase III nomenclature here. Again, all of that will be driven by emerging data.

至於那些可能比較接近第三階段的項目，那就比較難預測了。我認為 KRAS 專案、MCL-1 專案以及早期產品組合中的一些 BiTE（BCMA BiTE）可以過渡到潛在的註冊品質試驗。我未必會在這裡使用第三階段的命名法。再次強調，這一切都將由不斷湧現的數據驅動。

I think, Geoff, if you look at the oncology portfolio, just that segment alone, I think we're expecting report results on 7 of these assets during the course of 2019. So this would be an active year for us to share data with all of you.

傑夫，我認為，如果你看一下腫瘤產品組合，僅就這一個領域而言，我認為我們預計在 2019 年期間將公佈其中 7 項資產的業績報告。所以今年我們會積極與大家分享數據。

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。

I guess just like my peers, I'm trying to kind of work through the ups and downs of the guidance. So really 2 questions there. First, when we think about additional Sensipar competition, when is the earliest you -- in your low case you assume it could come? Is it midyear? Is it even early than that just based on the timing of the trial? And second, if we look at Aimovig, you kind of mentioned that you'll have higher paid prescription. I was wondering if you can give us a feel for where the pricing might end on the contract. I think Teva mentioned something between 4k and 4.5k as the kind of -- like the prevailing price when the market settled down. Is that roughly around what you guys think it will end up? Or is that range going to be higher than that?

我想，就像我的同齡人一樣，我正在努力應對指導過程中遇到的各種挑戰。所以其實有兩個問題。首先，當我們考慮 Sensipar 出現更多競爭對手時，您認為最早可能在什麼時候出現？ （以較低情況為例）現在是年中嗎？單從審判時間來看，現在判斷是否還太早？其次，如果我們看一下 Aimovig，你剛才提到過，它的處方藥價格會更高。我想請您大概介紹一下合約的最終價格可能是多少。我認為 Teva 提到 4000 到 4500 之間的價格，就像市場穩定下來後的普遍價格一樣。你們覺得最終結果大概是這樣嗎？或者這個範圍會比這更高？

Why don't we do it in 2 parts? David, why don't you address Sensipar?

為什麼不分成兩個部分來做呢？大衛，你為什麼不談談森西帕爾呢？

Yes. So in terms of -- if you look at the guidance that we provided, which, as I said, is a wider range than traditionally we would have, the primary driver of that increase in range, of course, is the uncertainty on Sensipar. And as to your question specifically, what we're anticipating now is that the litigation that's presently underway would conclude by around midyear, and that's how we're reflecting one of the scenarios in guidance to reflect that scenario.

是的。所以，就——如果你看一下我們提供的指導，正如我所說，這比我們以往的指導範圍要廣，當然，範圍擴大的主要驅動因素是 Sensipar 的不確定性。至於你提出的具體問題，我們目前預計正在進行的訴訟將在年中左右結束，這也是我們在指導意見中反映該情況的一種情景。

Yes. On Aimovig, I think I answered most of this before. And rather than give price-specific guidance on the product, I would say that we're pleased with how we've contracted for access so far. It is a competitive category. And then the other variable that we have to think about is the percentage of our prescriptions that get filled that's paid prescription versus free goods.

是的。關於 Aimovig，我想我之前已經回答過大部分問題了。與其給予具體的產品價格指導，不如說我們對目前為止的供貨合約簽訂情況感到滿意。這是一個競爭非常激烈的領域。我們還需要考慮的另一個變數是，我們處方藥中付費處方藥和免費藥品所佔的比例。

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。

A question for Bob. In the past, you've talked about various degrees of appetite for M&A. You talked about overcapacity in the industry. Maybe you could just revisit your thoughts around the degree of appetite. And more importantly, I'm sure you're aware of the various industry chatter about mega mergers and where Amgen's view is on mega mergers. So maybe just comment about that and to what degree you can clear that up for people?

問鮑伯一個問題。過去，您曾談到不同程度的併購意願。你談到了產業產能過剩的問題。或許你可以重新檢視一下你的食慾程度。更重要的是，我相信您也了解業界關於巨型併購的各種傳言，以及安進公司對巨型併購的看法。所以，或許你可以就此發表一下看法，以及你能在多大程度上為人們澄清這個問題？

Sure, Michael. I think our view on this has been consistent now for a while, which is we're looking at opportunities to invest in the business. Our focus is on innovation. We're likely to look most closely in those areas where we feel we can add value and create value for our shareholders. So that would imply the therapeutic areas that we're focused on. We do think there will be opportunities. We think we have the flexibility to look at those, the balance sheet and the management resources to look at those transactions. And with stocks down considerably from where they were a year ago, I would expect that we will continue to look and look across the waterfront of small and larger deals. Obviously, there are more smaller ones than large ones. So we tend to spend more of our time looking at those but we're consistent with what we said now for a while. We're looking across the waterfront to find ways to invest in the industry in ways that we think we can add value for our shareholders, not just the target shareholders.

當然可以，麥可。我認為我們對此的看法一直很一致，那就是我們正在尋找投資該業務的機會。我們專注於創新。我們可能會專注於那些我們認為能夠為股東創造價值並增加價值的領域。所以這就能說明我們關注的治療領域了。我們認為會有機會。我們認為我們有足夠的彈性來審視這些，包括資產負債表和管理資源，以便審視這些交易。由於股票價格較一年前大幅下跌，我預計我們將繼續密切關注各種規模的交易機會。顯然，小的比大的多。所以我們往往會花更多時間關注這些，但我們一段時間都會堅持我們剛才所說的話。我們正在放眼整個產業，尋找投資方式，以期為我們的股東（而不僅僅是目標股東）創造價值。

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

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

David, you spent quite a bit of time talking about the last 5 years, and I just would like you to give some sense of your outlook for the next 5 years. I'm sure you have a very detailed operating plan in place already, but many of the trends that have been highlighted on this call and your guidance have been coming for some time, Neulasta, Sensipar, et cetera. So if you can give us a sense of how long it might be before you see the current R&D portfolio providing enough opportunity to offset what's likely to be several years of erosion of these very successful legacy products.

大衛，你花了不少時間談論過去五年，我只是想請你談談對未來五年的展望。我相信你們已經制定了非常詳細的營運計劃，但是本次電話會議中強調的許多趨勢以及你們的指導意見，例如 Neulasta、Sensipar 等，其實已經出現了一段時間了。因此，如果您能告訴我們，目前的研發組合需要多久才能提供足夠的機會來抵消這些非常成功的傳統產品可能在未來幾年內逐漸衰落的影響，那就太好了。

Sure. So, yes, I'm trying to think of how to frame the answer to the question, Geoff. So certainly, what we see now and if I look, as an example, the performance in the fourth quarter, even the full year in 2018 where we have had and we continue to see increasing competition against our legacy products, we're quite pleased to see that our global volume growth last quarter was 10% and for the company in 2018 was 5% volume growth. So that gives us some positive confidence, as we look at the existing portfolio of products that are in the market right now, that they are going to provide very strong and stable growth, which will help us to offset the impact of our legacy declines. What's also true this year is we have an increasing portfolio of our own biologics in the -- biosimilars in the market, which are also going to support growth for the company. And then finally, as you're asking about what about the emerging portfolio, both of our late-stage trials of products that are more in Phase III already and the emerging oncology portfolio, quite frankly, it's a little bit early notwithstanding you're giving me credit for a lot of detail. It's a little imprecise right now especially on these earlier stage products, but we are encouraged by the speed at which they're coming forward. And certainly, in the oncology area, these products have a chance to impact quite quickly as compared to some of the other therapeutic areas. So that's the best I can offer you on that piece.

當然。是的，傑夫，我正在思考如何回答這個問題。所以，我們現在看到的，例如，以第四季度甚至 2018 年全年業績為例，儘管我們一直面臨著來自傳統產品的日益激烈的競爭，但我們非常高興地看到，上個季度我們全球銷量增長了 10%，而公司 2018 年的銷量增長了 5%。因此，當我們審視目前市場上現有的產品組合時，我們有理由相信它們將帶來非常強勁且穩定的成長，這將有助於我們抵消以往業績下滑的影響。今年另一個變化是，我們自主研發的生物製劑（包括生物相似藥）產品組合不斷擴大，這也將支持公司的成長。最後，既然你問到了新興產品組合的情況，包括我們目前處於 III 期臨床試驗階段的產品以及新興的腫瘤產品組合，坦白說，現在談論這些還為時過早，儘管你對我提供的細節給予了很高的評價。目前，尤其是在這些早期階段的產品上，情況還不太準確，但我們對它們的發展速度感到鼓舞。當然，在腫瘤領域，與一些其他治療領域相比，這些產品有機會迅速產生影響。這就是我能提供給你的全部資訊了。

I think I'd reiterate, Geoff, what we've said in a variety of different ways, which is we think we're well positioned now to deliver on our long-term growth aspirations. So look forward to doing just that.

傑夫，我想重申我們之前用各種不同方式表達過的觀點，那就是我們認為我們現在處於有利地位，可以實現我們的長期成長目標。所以，敬請期待吧。

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

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

I actually had a question for David and David. So the first one was on -- and they can pick whichever one. The first one was on operating margin, and my question really was not so much looking for guidance but hoping to understand, do -- is there -- as we enter -- as revenues grow in the future, would you expect the dollar OpEx to grow slower than that? That was the first. And the second one is KRAS is something -- and I think some of your comments at a few conferences in the last few weeks have generated a lot of investor interest. So my question is from these early scans in this relatively new trial, what are you seeing on the G12C? And would you think of this drug as a potentially best-in-class?

我其實有個問題想問大衛和大衛。所以第一個就開始了——他們可以任一個。第一個問題是關於營業利潤率的，我的問題其實並不是尋求指導，而是希望了解，隨著未來收入的成長，您是否預期美元營運支出成長速度會低於預期？那是第一個。第二點是 KRAS 是一回事——我認為你在過去幾週的一些會議上發表的評論引起了投資者的極大興趣。所以我的問題是，從這項相對較新的試驗的早期掃描結果來看，您在 G12C 上看到了什麼？你認為這種藥物有可能成為同類最佳藥物嗎？

Yes. So in terms of, Umer, operating expenses and trends there, what I would say is a couple of things. One is as we know, we put the company in a really nice position in terms of our financial performance based on the work that we've done over these last several years, and we enter the period of 2019 with quite a lean cost structure. What's also true, as I mentioned in my comments, the good news is that there's always more opportunities. The business changes. We see that there's more productivity to be had, and we think that will be an important source of financial flexibility to allow us to continue to invest going forward. And I talked about the trends that we expect in the different categories this year. I think your longer-term question, which is do we expect that in the context of a growing revenue base that we're going to get leverage off of that revenue vis-à-vis our expenses, I would say that certainly, we'd be committed to that type of performance for the company through time. And I would say as we move into the future, we'll be able to give you some more specifics as to how we're thinking about that.

是的。所以就 Umer 的營運費用和趨勢而言，我想說幾點。一是我們都知道，基於過去幾年我們所做的工作，我們已經使公司在財務業績方面處於非常有利的地位，並且我們以相當精簡的成本結構進入了 2019 年。正如我在評論中提到的，好消息是，總是會有更多機會。商業環境會改變。我們看到還有提升生產力的空間，我們認為這將是財務靈活性的重要來源，使我們能夠繼續進行未來的投資。我談到了我們預計今年各個類別的發展趨勢。我認為你提出的長期問題是，隨著收入基礎的成長，我們是否期望能夠利用收入來抵銷支出，對此我表示肯定，我們致力於長期為公司實現這種業績。隨著我們展望未來，我們將能夠為您提供更多關於我們對此的看法。

Yes. With regards to the KRAS question, as you know, this has been a holy grail of target for 35 or 40 years now. We were very happy to be first in the clinic. We are moving briskly through the Phase I dose escalation. We expect to be able to share, hopefully by midyear, initial results from that first-in-human trial. In terms of best-in-class, we're really only right now in terms of where we are in dose escalation. Ultimately, everything will depend on clinical data. I don't think it's really helpful to speculate much beyond that.

是的。關於 KRAS 問題，如您所知，這在過去 35 到 40 年裡一直是 Target 的聖杯。我們很高興成為診所的第一批患者。我們正在快速推進 I 期劑量遞增試驗。我們預計最快可以在年中公佈首次人體試驗的初步結果。就同​​類最佳而言，我們目前真正處於最佳水平的只是劑量遞增階段。最終，一切都將取決於臨床數據。我認為再做更多推測並沒有什麼實際幫助。

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

下一個問題來自花旗銀行的 Robyn Karnauskas。

So I just wanted to clarify a couple of things on just the Neulasta guidance. So first of all, is Onpro protecting you at all? I know Mylan said that they have 18% to 20% share in the injectable market. And going with that, do you -- how much insight -- how much comfort do you think you really have into the 2 generics that are on the market right now and their impact on 2019? Meaning, is that -- like is the range a little bit less than what you're saying that you described for Sensipar for your guidance?

所以我想就 Neulasta 的指導說明澄清幾點。首先，Onpro到底能不能起到保護作用？我知道邁蘭公司曾表示，他們在註射劑市場佔有 18% 到 20% 的份額。那麼，基於上述分析，您認為您對目前市場上兩種仿製藥及其對 2019 年的影響究竟有多少了解、有多少把握？也就是說，這個範圍是否比您之前描述的 Sensipar 的範圍略小一些？

Yes. Robyn, let me try to go over some of the things that we are seeing with Neulasta. As we expected at the end of last year, we saw an additional long-acting biosimilar approved. And we have, so far, seen their actions in the market as consistent with what we had expected. We are seeing very good uptake of Onpro. We're over 60% penetrated now with Onpro across our business. And we would anticipate that, that differentiated offering of having both Onpro and our other formulation that we will be able to drive some differentiation with institutions, clinics and providers. And so that is indeed the differentiated strategy that we'll pursue going forward. However, given that we're going to have now 2 long-acting biosimilars and we're assuming that there's a potential for additional before the end of the year, we would expect to see some share erosion in 2019.

是的。Robyn，讓我試著跟你談談我們目前在Neulasta身上看到的一些情況。正如我們去年年底所預期的那樣，我們看到另一種長效生物類似藥獲得批准。到目前為止，我們看到他們在市場上的行為與我們的預期一致。我們看到Onpro的市場反應非常好。目前，Onpro 在我們公司的滲透率已超過 60%。我們預計，憑藉 Onpro 和我們其他配方的差異化產品，我們將能夠與機構、診所和醫療服務提供者建立差異化優勢。因此，這確實是我們今後將要採取的差異化策略。然而，鑑於我們現在將有 2 種長效生物類似藥，並且我們假設在年底前還有可能出現更多，我們預計 2019 年市場份額將會下降。

Maybe I'd add. If you look, it comes back a bit, I think, to your question to the guidance and how broad it is. And as I said earlier, Robyn, the primary driver of that additional guidance range is, of course, Sensipar. But I think it's fair to say that there are other factors embedded there. So if not for Sensipar, perhaps our guidance would have been a little bit broader than traditionally would be the case, including the uncertainties around the path for Neulasta, which is obviously an important product for us.

或許我會補充一點。我認為，仔細想想，這其實多少還是回到了你提出的關於指導方針及其適用範圍的問題。正如我之前所說，Robyn，推動這項額外指導的主要因素當然是 Sensipar。但我認為可以公平地說，其中還包含其他因素。因此，如果不是因為 Sensipar，我們的指導意見可能會比以往更加廣泛一些，包括 Neulasta 的發展路徑的不確定性，這顯然是我們的一個重要產品。

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 wanted to ask about when you might expect an initial verdict from the litigation around Enbrel's IP? And can you walk us through the potential scenarios that you see there?

我想問的是，您預計何時能對圍繞恩利（Enbrel）智慧財產權的訴訟做出初步判決？您能否為我們詳細介紹一下您認為可能出現的情況？

Well, Cory, as you pointed out in your question, we were in the District Court defending the intellectual property around Enbrel. We feel good about the intellectual property surrounding Enbrel, but the District Court needs to render a judgment and we think it will happen at some point later this quarter. And then obviously, it could even be later than that, Cory, but then obviously, whatever the decision is, I'll remind you that Sandoz has agreed they infringe. The question is whether the IP is valid. And whatever the decision, I'm sure you can expect there would be appeals. So this process will run on now for a little while, I would suspect.

科里，正如你在問題中指出的那樣，我們當時正在地區法院捍衛恩利（Enbrel）相關的智慧財產權。我們對 Enbrel 相關的智慧財產權感到樂觀，但地方法院需要判決，我們認為判決將在本季稍後做出。當然，科里，這件事可能還會持續更久，但無論最終決定如何，我都要提醒你，山德士已經承認他們侵權了。問題是該IP位址是否有效。無論最終決定如何，我相信肯定會有上訴。因此，我估計這個過程還會持續一段時間。

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。

Just one on EVENITY. If it happens to be approved, I guess, have your perspectives or views changed on what the potential market opportunity? And then just one quick one on Enbrel. I see that the quarter-over-quarter trends have been fairly stable. I'm just wondering if we should think about kind of the trends over the next couple of quarters in 2019 should they be stable as well?

EVENITY 上只有一張。如果最終獲得批准，我想，您對潛在市場機會的看法或觀點是否有所改變？然後就簡單問一下關於恩利的問題。我發現季度環比趨勢相當穩定。我只是在想，我們是否應該考慮一下2019年接下來幾季的趨勢，看看它們是否也會保持穩定？

Maybe I'll start with Enbrel. I would say that we have seen stability in Enbrel both in share performance as well as price evolution and I think that those -- both of those will continue to be stable going into the new year at least over the foreseeable few quarters. And then on EVENITY, we continue to see EVENITY as a really good complement to our overall focus on bone health. And with the approval in Japan for high-risk patients and the FDA decision with the AdCom, most of that is consistent with what we had planned for the product and how it would be positioned in the market but however there's still a lot of work and discussions still to have with the FDA.

或許我會先試試恩利。我認為，無論是在股價表現還是價格走勢方面，Enbrel 都表現出了穩定性，而且我認為，至少在可預見的幾個季度內，這兩方面都將在新的一年裡繼續保持穩定。至於 EVENITY，我們仍然認為 EVENITY 是我們整體關注骨骼健康的一個很好的補充。在日本獲得高風險患者批准，以及美國食品藥物管理局 (FDA) 和諮詢委員會 (AdCom) 做出的決定，大部分都與我們對該產品的計劃及其市場定位相符，但是，我們仍然需要與 FDA 進行大量的工作和討論。

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。

For David, on the biosimilar franchise, you mentioned you've done the Phase III study of biosimilar, Soliris. Can you confirm that you've enrolled patients into that study? And if so, was the team waiting on any gating factors prior to moving ahead with the trial?

David，關於生物相似藥產品線，你提到你已經完成了生物相似藥 Soliris 的 III 期研究。您能確認是否已經招募患者參與這項研究嗎？如果是這樣，那麼在進行試驗之前，團隊是否在等待任何阻礙因素？

Yes, I can confirm that we're screening patients. We expect enrollment to begin anytime now. The launch of the trial was really predicated on regulatory discussions that we had around the world to agree on the appropriate design end points and approvability.

是的，我可以確認我們正在對患者進行篩檢。我們預計招生工作隨時可能開始。試驗的啟動實際上是基於我們與世界各地監管機構進行的討論，以就適當的設計終點和可批准性達成一致。

I think the other thing -- maybe I'll add, Kennen, on that, is we think we're in pretty good shape here. We think -- we're excited to run the trial and establish biosimilarity, safety and efficacy. And with the recent patent decision in Europe in our favor, we're looking forward to having those data, seeking registration and beginning to serve patients.

我認為還有一點——肯南，也許我應該補充一點——我們認為我們目前的情況相當不錯。我們認為——我們很興奮能夠進行試驗並確定生物相似性、安全性和有效性。鑑於最近歐洲的專利裁決對我們有利，我們期待獲得這些數據，申請註冊並開始為患者服務。

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。

One on just Repatha, the lower-priced SKU. So when you're looking at your percentage of revenues coming from that lower-priced SKU, could you give us the payer split in the Medicare, Medicaid and from commercial? Is it anywhere close to the natural distribution that you put out when you had the call in October?

僅 Repatha（價格較低的 SKU）一款。那麼，當您查看來自低價 SKU 的收入百分比時，您能否提供 Medicare、Medicaid 和商業保險的支付方比例？它與您在 10 月發布看漲期權時所預測的自然分佈情況有接近的程度嗎？

Yes. Thanks, Salim. It's -- actually, right now, of total units that we're selling, it's over 25%. And it's roughly 43% of Medicare lives that have coverage, and it does skew a little more to Medicare than it does commercial at this point in time. But it's evolving fairly rapidly and is -- I wouldn't say that's steady state by any stretch.

是的。謝謝你，薩利姆。實際上，目前在我們銷售的總單位中，超過 25%。大約有 43% 的聯邦醫療保險參保人擁有醫療保險，目前來看，聯邦醫療保險參保人比商業保險參保人略多一些。但它的發展速度相當快，而且──我絕對不會說它已經處於穩定狀態。

(Operator Instructions) And our next question is from the line of Phil Nadeau from Cowen and Company.

（操作說明）我們的下一個問題來自 Cowen and Company 的 Phil Nadeau。

Just one on the overall pricing dynamics. David, in the prepared remarks, you mentioned that pricing was going to decline mid-single digits in 2019. That's versus 1% in 2018. Can you discuss what you expect longer term on pricing? Is 2019 the new normal? Or are there some elements in 2019, due to the competitive product launches and price cuts, that will make that more severe for net pricing than we should expect in the future?

僅就整體定價動態而言。戴維，你在準備好的發言稿中提到，2019 年價格將下降個位數百分比。而2018年這一比例為1%。您能否談談您對長期價格走勢的預期？2019年是新常態嗎？或者，由於競爭激烈的產品發布和價格下調，2019 年是否存在某些因素，使得淨定價面臨的挑戰比我們未來預期的要大？

Yes. So we wanted to communicate the outlook for net price for 2019. And I guess what I would say is that from a macro perspective in the U.S. market, I think we've been quite consistent in expecting that we would see more pressure on price, a combination of increasing intensity of competition, the concerns about affordability that are expressed in the regulatory and political environment. And then I would say in addition to that, for us specifically in '19, as Murdo commented, there are some specific cases where we have products that are either facing new competition in their post-exclusivity period or other factors that are impacting pricing. So I wouldn't draw a conclusion that that's a new, permanent level of price performance for Amgen, but I would say that it is fair to assume and we've been assuming a tougher pricing environment, which is why we've gone about putting ourselves in a very competitive position from a efficiency and cost perspective, and why we continue to be very careful in terms of making sure we're going after new pipeline products that really change the standard of care because those are the products where we'll be able to get a return going forward.

是的。因此，我們想向大家介紹一下 2019 年的淨價預期。我想說的是，從美國市場的宏觀角度來看，我們一直都預期價格會面臨更大的壓力，這是由於競爭日益激烈，以及監管和政治環境中對價格承受能力的擔憂共同造成的。此外，我想補充一點，就我們而言，正如 Murdo 所評論的那樣，在 2019 年，有一些特殊情況，我們的產品要么在獨家銷售期結束後面臨新的競爭，要么面臨其他影響定價的因素。因此，我不會就此得出結論，認為這是安進公司新的、永久性的價格表現水平，但我認為，假設（而且我們也一直假設）定價環境會更加嚴峻是合理的，這就是為什麼我們從效率和成本的角度讓自己處於非常有競爭力的地位，也是為什麼我們繼續非常謹慎地確保我們追求產品是真正改變治療標準的新回報，因為這些產品才能讓我們在未來獲得新回報，因為未來的新回報

(Operator Instructions)

（操作說明）

Okay. If there are no further questions, Bob, do you want to make some closing comments?

好的。鮑勃，如果沒有其他問題，你還有什麼要補充的嗎？

Sure. Thank you all again for dialing in to our fourth quarter call. We're excited about the outlook for the future. I hope by now, we established with you and our shareholders, as I know we have with our staff, a good track record of delivering against our financial commitments, and we look forward to doing that again this year. With the actions that we've taken to transform the company, we think we're well positioned to deliver our long-term growth aspirations. And we're encouraged, as you've heard us say in this Q&A, about the momentum that we see for our newer products and the pipeline of differentiated first-in-class molecules we've been rapidly advancing. So with our strong balance sheet and cash flows, we expect to continue to invest in this business and to deliver return for our shareholders. So thanks for joining, and we look forward to talking to you again in April. And of course, in the meantime, Arvind and his team are here to take any questions if you didn't get a chance to ask him on the call.

當然。再次感謝各位撥入我們的第四季電話會議。我們對未來前景感到興奮。我希望到目前為止，我們已經像對待員工一樣，與您和我們的股東建立了良好的履行財務承諾的記錄，我們期待今年繼續這樣做。透過我們為公司轉型所採取的行動，我們認為我們有能力實現我們的長期成長目標。正如您在本次問答中聽到的那樣，我們對新產品的發展勢頭以及我們一直在快速推進的差異化首創分子產品線感到鼓舞。憑藉我們強勁的資產負債表和現金流，我們預計將繼續投資於這項業務，並為我們的股東帶來回報。感謝您的參與，我們期待四月再次與您交流。當然，與此同時，如果您在電話會議上沒有機會向 Arvind 提問，他和他的團隊隨時準備回答您的任何問題。

Thank you, everybody.

謝謝大家。

Ladies and gentlemen, this does conclude today's Amgen's Fourth Quarter 2018 Financial Results Conference Call. We thank you for your participation. You may now disconnect.

女士們、先生們，安進公司2018年第四季財務業績電話會議到此結束。感謝您的參與。您現在可以斷開連線了。