美國安進 (AMGN) 2017 Q4 法說會逐字稿

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

我叫史金納，今天我將擔任安進公司 2017 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, Skinner. Good afternoon, everybody. I'd like to welcome you to our conference call to discuss our business performance for 2017 and our outlook for 2018. Although our results exemplify our focus on volume-driven growth, tax reform has created profound changes and opportunities for our industry and our company. So to begin this dialog, our Chairman and CEO, Bob Bradway, will provide some perspective, followed by our CFO, David Meline, who will review our Q4 and full year 2017 results and provide guidance for 2018. Our Head of Global Commercial Operations, Tony Hooper, will review our product and geographic performance in 2017. Followed by our Head of R&D, Sean Harper, who will provide a pipeline update.

好的。謝謝你，史金納。大家下午好。歡迎各位參加我們的電話會議，我們將討論公司 2017 年的業務表現以及 2018 年的展望。儘管我們的業績體現了我們對銷售驅動成長的重視，但稅收改革為我們的行業和公司帶來了深刻的變化和機會。為了開啟本次對話，我們的董事長兼執行長鮑勃·布拉德韋將提供一些觀點，隨後我們的財務長大衛·梅林將回顧我們 2017 年第四季和全年的業績，並對 2018 年做出指導。我們的全球商業營運主管托尼胡珀將對我們 2017 年的產品和地理業績進行評估。接下來，我們的研發主管肖恩哈珀將介紹產品線的最新進展。

As in the past, we will use slides corresponding to our presentation today and a link to these slides was sent earlier.

與以往一樣，我們將使用與今天演講相對應的幻燈片，這些幻燈片的連結已於先前發送。

We plan on using non-GAAP financial measures in today's presentation to provide information, which may be useful in understanding our ongoing business performance. However, these non-GAAP financial measures should be considered together with GAAP results, and reconciliations of these measures are available in the schedule accompanying today's press release, our Form 8-K and also on the Investor Relations section of our website.

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

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

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

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

那麼，接下來我將把電話交給鮑伯。

Okay. Thank you for joining our call. We have more ground than usual to cover with you in our prepared remarks this afternoon. We'll be addressing not only our results for 2017 and our outlook for this year, but also the impact of tax reform, which we see as a very favorable development for our business. To kick off, I'd offer that with another year of strong performance behind us. We're even more excited about the long-term prospects for our business than we were a year ago.

好的。感謝您參加我們的電話會議。今天下午，我們需要在準備好的演講稿中涵蓋比平常更多的內容。我們不僅會討論 2017 年的業績和今年的展望，還會討論稅制改革的影響，我們認為這對我們的業務來說是一個非常有利的發展。首先，我想說，在過去一年裡，我們取得了另一個強勁的成績。與一年前相比，我們現在對公司的長期前景更加充滿信心。

In 2017, we continued to deliver solid operating performance, and earnings per share growing 8%, and operating margins improving to an industry-leading 53.5%. In capital terms, payout to our shareholders grew by 14%, and we improved our return on capital to 33%. We delivered these results in a period of increased competition from many of our largest products, several of which have lost patent protection, and while continuing to invest heavily in the future of our business. Our steady progress through 2017 places us squarely on track to deliver against the long-term commitments we set several years ago for 2018.

2017年，我們持續維持穩健的經營業績，每股盈餘成長8%，營業利益率提升至業界領先的53.5%。從資本角度來看，我們向股東支付的股息增加了 14%，資本回報率提高到 33%。我們是在面臨來自許多最暢銷產品日益激烈的競爭（其中一些產品已失去專利保護）的同時，取得了這些成果，同時我們也繼續對公司的未來進行大量投資。我們在 2017 年取得的穩定進展，使我們完全走在實現幾年前為 2018 年制定的長期承諾的軌道上。

We entered 2018 in a firm position. I'm confident about our long-term outlook. Those franchises which have come off patent in nephrology and oncology have held up well, and we expect them to remain competitive.

2018年伊始，我們便處於穩固的地位。我對我們的長期前景充滿信心。那些在腎臟病學和腫瘤學領域專利到期的特許經營權表現良好，我們預計它們將繼續保持競爭力。

The brands that we expect to drive our future growth, led, of course, by Repatha, Prolia and KYPROLIS, with Aimovig and the biosimilars coming close behind, are emerging, now and the strong data we have to support them are encouraging.

我們期望推動未來成長的品牌，當然以 Repatha、Prolia 和 KYPROLIS 為首，Aimovig 和生物相似藥緊隨其後，這些品牌正在崛起，我們擁有的強有力的數據支持它們，這令人鼓舞。

And finally, we have stable cash flows and a strong balance sheet, both of which are improved by tax reform. We intend to use our resources to continue to invest in our people and the attractive long-term growth opportunities we see in our industry, including M&A where it fits our focus, while also returning capital to our shareholders.

最後，我們擁有穩定的現金流和強勁的資產負債表，這兩方面都因稅制改革而得到改善。我們打算利用我們的資源繼續投資於我們的員工和我們看到的行業中具有吸引力的長期成長機會，包括符合我們重點的併購，同時向股東返還資本。

To be successful in the long run in our industry, we think it will be essential to have innovative differentiated medicines that deliver large beneficial effects for patients suffering from serious illness and to demonstrate that these medicines provide value for all stakeholders in the health care system.

我們認為，要想在醫藥行業取得長期的成功，至關重要的是擁有創新且差異化的藥物，這些藥物能夠為患有嚴重疾病的患者帶來巨大的益處，並證明這些藥物能夠為醫療保健系統中的所有利益相關者帶來價值。

We have a number of these medicines on the market now and in our pipeline, some of which meet the needs of large patient populations and some of which are for more specialized markets.

我們目前已有許多此類藥物上市，還有一些正在研發中，其中一些滿足了廣大患者的需求，而另一些則面向更專業的市場。

With pressure on prices globally, we think revenue growth will be more tightly linked to volume growth than was the case historically. In this regard, medicines that serve the needs of large number of patients will be particularly attractive growth drivers. Repatha is a clear example of this.

鑑於全球價格面臨壓力，我們認為營收成長將比以往更加緊密地與銷售成長掛鉤。在這方面，能夠滿足大量患者需求的藥物將成為特別有吸引力的成長動力。瑞百莎就是一個明顯的例子。

On this call last year, we announced the successful conclusion of the Repatha outcomes trial. Now following an expedited review by the FDA, we're able to talk to patients, payers and prescribers about the unique role of Repatha in significantly reducing the risk of heart attack and stroke. Cardiovascular disease is the single greatest problem facing health care systems around the world today. And as the population ages globally, this problem will only grow unless we embrace important new innovations. Repatha is exactly the type of innovation needed today by millions of patients to bring down the risk of cardiovascular disease. Our job now is to see that prescribers, patients and payers understand this product and recognize the importance of adopting it for high-risk patients.

在去年的電話會議上，我們宣布了 Repatha 結果試驗的成功完成。現在，經過 FDA 的快速審查，我們能夠與患者、付款者和處方醫生討論 Repatha 在顯著降低心臟病發作和中風風險方面的獨特作用。心血管疾病是當今世界各國醫療保健系統面臨的最大難題。隨著全球人口老化，除非我們接受重要的創新，否則這個問題只會愈演愈烈。Repatha正是當今數百萬患者降低心血管疾病風險所需的創新藥物。我們現在的工作是確保處方醫生、患者和支付方了解該產品，並認識到對高風險患者採用該產品的重要性。

As they do, we expect Repatha to be an important growth driver for us for many years to come. We'll continue to work to ensure that patients gain access to this therapy worldwide, especially those for whom other therapies have not proven effective.

隨著他們的發展，我們預計 Repatha 在未來許多年成為我們重要的成長動力。我們將繼續努力，確保世界各地的患者都能獲得這種療法，特別是那些其他療法無效的患者。

Like Repatha, Prolia represented a paradigm-changing biologic when it was first launched for osteoporosis. Today, it is, of course, the leading osteoporosis therapy. In fact, there are 3.5 million patients worldwide taking Prolia, and the demand for it continues to grow by double-digit percentages. With only 25% of women in the U.S. who might benefit from osteoporosis therapy receiving it, we continue to see significant growth potential for Prolia in osteoporosis.

與 Repatha 一樣，Prolia 在首次推出用於治療骨質疏鬆症時，代表了一種改變模式的生物製劑。當然，如今它已成為治療骨質疏鬆症的主要療法。事實上，全球有 350 萬名患者正在服用 Prolia，而且對它的需求還在以兩位數的百分比持續成長。在美國，只有 25% 的女性可能受益於骨質疏鬆症治療，但她們接受了治療，因此我們繼續看到 Prolia 在骨質疏鬆症領域具有巨大的成長潛力。

In our pipeline, I would highlight 2 products which have similar attractive characteristics but which address more symptomatic diseases. One of these is Aimovig, our first-in-class product to prevent migraine. Current therapies don't work adequately for this debilitating disease, and patients and prescribers are anxious to have a better option. We're hopeful that Aimovig, which uniquely blocks the CGRP receptor, will be the answer that millions of patients have been waiting for.

在我們的研發管線中，我想重點介紹兩款具有相似吸引力特性的產品，但它們主要針對的是症狀性疾病。其中之一是 Aimovig，這是我們首款預防偏頭痛的產品。目前的療法對這種使人衰弱的疾病效果不佳，患者和醫生都渴望有更好的治療方案。我們希望Aimovig（一種能夠獨特阻斷CGRP受體的藥物）能夠成為數百萬患者一直期盼的答案。

The other product I would highlight is tezepelumab, a first-in-class molecule that has shown very encouraging Phase II results in treating asthma. There are millions of asthma sufferers worldwide in need of better therapy. We're hopeful that tezepelumab might be just that, and we're actively enrolling a Phase III trial to establish the answer.

另一款我要重點介紹的產品是tezepelumab，這是一種首創分子，在治療氣喘方面已顯示出非常令人鼓舞的 II 期臨床試驗結果。全世界有數百萬名氣喘患者需要更好的治療方法。我們希望 tezepelumab 能夠達到預期效果，我們正在積極進行 III 期試驗以確定答案。

We've enjoyed great success in specialty markets historically, and with our innovative medicines, we expect that to continue. XGEVA represents a good example of this. And with the addition of multiple myeloma to our label, we would expect to see more growth from this product beginning in 2018.

我們歷來在專業市場取得了巨大的成功，憑藉我們的創新藥物，我們預計這種情況將持續下去。XGEVA 就是一個很好的例子。隨著多發性骨髓瘤被納入我們的產品標籤，我們預計該產品從 2018 年開始將實現更大的成長。

In cancer, more generally, overall survival is the gold standard. We entered 2018 with fresh overall survival data in our labels for KYPROLIS and BLINCYTO. KYPROLIS has established strong share in second and later lines of multiple myeloma therapy, and we expect the addition of overall survival data to strengthen its appeal to physicians, payers and patients.

在癌症治療領域，整體存活率是衡量療效的黃金標準。2018 年，我們在 KYPROLIS 和 BLINCYTO 的標籤中加入了最新的整體存活數據。KYPROLIS 在多發性骨髓瘤二線及後續治療中已佔據重要份額，我們預計總生存期數據的加入將增強其對醫生、支付方和患者的吸引力。

With overall survival for relapse refractory acute lymphoblastic leukemia patients, BLINCYTO was a game-changer in its own right, but importantly, it provides confidence for the long-term outlook for our broader BiTE platform. We have 12 BiTE programs progressing in both liquid and solid tumors. And data over the next 2 years will inform the future for many of these molecules.

BLINCYTO 本身就改變了復發難治性急性淋巴性白血病患者的整體存活率，但更重要的是，它為我們更廣泛的 BiTE 平台的長期前景提供了信心。我們有 12 個 BiTE 項目正在推進，涵蓋血液腫瘤和實體腫瘤。未來兩年的數據將為許多這類分子的未來發展提供基礎。

2018 will be another year of new product launches for Amgen. In addition to our launch plans for Aimovig, we are extending our long-standing leadership in nephrology with the launch of Parsabiv, a specialty product for kidney disease in a number of companies -- countries rather, including the U.S.

2018年將是安進公司推出新產品的另一年。除了我們推出 Aimovig 的計劃外，我們還透過在包括美國在內的多家公司（更確切地說是多個國家）推出用於治療腎臟疾病的特效藥 Parsabiv，進一步鞏固了我們在腎臟病領域的長期領先地位。

And finally, I want to highlight that we have clarity now around AMGEVITA, our adalimumab biosimilar, and we look forward to launching that internationally later in the year. This will be the first of our biosimilars to launch. We have a strong portfolio coming behind it with one other approval already and several Phase III programs awaiting approval and launch. We think this recommend -- represent compelling growth opportunities for us around the world.

最後，我想強調的是，我們現在對我們的阿達木單抗生物相似藥 AMGEVITA 有了清晰的了解，我們期待在今年稍後在國際上推出該產品。這將是我們首個上市的生物相似藥。我們還有強大的產品組合在支撐著這個項目，其中一項已經獲得批准，還有幾個三期臨床試驗項目正在等待批准和啟動。我們認為這些建議代表著我們在全球範圍內極具吸引力的成長機會。

We think tax reform provides a number of important benefits for our company. First, it puts us on a more level playing field strategically with our international competitors who previously were advantaged by lower rates and global access to their cash. Second, in addition to a more level playing field, tax reform clearly provides incentives for us to invest heavily in innovation and advanced technologies here in the U.S., and that is exactly what we will do. The timing of tax reform is particularly relevant for us right now as we are on the cusp of deploying our so-called next-generation biomanufacturing technologies, which enable us to make biologics with much improved productivity, a smaller footprint and much reduced levels of waste and environmental impact.

我們認為稅制改革能為公司帶來許多重要的好處。首先，這使我們在策略上與國際競爭對手處於更公平的競爭環境，而此前國際競爭對手憑藉較低的利率和全球現金獲取管道獲得了優勢。其次，除了創造一個更公平的競爭環境外，稅改顯然也為我們提供了激勵，促使我們在美國大力投資創新和先進技術，而這正是我們將要做的。稅收改革的時機對我們來說現在尤其重要，因為我們正處於部署所謂下一代生物製造技術的風口浪尖，這些技術使我們能夠以更高的生產效率、更小的佔地面積和更低的廢物及環境影響來生產生物製劑。

We developed these technologies in the U.S., and thanks to tax reform, we will now build new manufacturing capacity and add highly skilled jobs here in the U.S. to capitalize on them.

這些技術是我們在美國研發的，由於稅制改革，我們現在將在美國建立新的生產能力，並增加高技能就業崗位，以充分利用這些技術。

It's worth noting that with tax reform, we'll make products in the U.S. and export it to cover 85% of our international sales.

值得注意的是，隨著稅制改革的實施，我們將在美國生產產品並出口，以滿足我們85%的國際銷售。

With improved clarity on tax reform, we expect to invest on the order of $2.5 billion in capital expenditures in the U.S. over the next 5 years.

隨著稅收改革情勢的日益明朗，我們預計未來 5 年將在美國進行約 25 億美元的資本支出投資。

We see tax reform benefiting us in other areas as well. Amgen Ventures, our vehicle for early-stage investing, will also make close to $300 million available for new investments in innovative biotechnology, digital and health care information companies. We'll also grow our already substantial commitment to our communities with plans for the Amgen Foundation's investments in the proven Amgen Scholars and Amgen Biotech Experience programs, which we expect to reach $100 million of commitment within 4 years.

我們看到稅制改革在其他方面也使我們受益。安進創投（Amgen Ventures）是我們早期投資的管道，也將提供近 3 億美元，用於對創新生物技術、數位和醫療保健資訊公司進行新的投資。我們還將增加對社區的投入，安進基金會計劃加大對已取得成功的安進學者計劃和安進生物技術體驗計劃的投資，預計在 4 年內投入將達到 1 億美元。

We have engaged some 600,000 high school and college students in person through these programs. Consider this our commitment to helping build a pipeline of talented scientists and biologists in the U.S. and beyond.

我們透過這些計畫與大約 60 萬名高中生和大學生進行了面對面的交流。請將此視為我們致力於幫助美國及其他地區培養優秀科學家和生物學家的決心。

Through our foundation's philanthropic giving, we expect to deploy $100 million over the next 5 years in the communities where we work and live. We've also assessed that tax reform will be generally positive for our staff, especially for our nonexecutive U.S. staff a number about 12,000. We estimate that lower personal tax rates, combined with investments we are making in enhancing base wages for these staff, will create literally thousands of dollars of improvement in the average take-home pay for our typical U.S. nonexecutive staff member.

透過我們基金會的慈善捐贈，我們預計在未來 5 年內向我們工作和生活的社區投入 1 億美元。我們也評估認為，稅務改革對我們的員工來說總體上是正面的，尤其是對我們約 12,000 名非管理層美國員工而言。我們估計，降低個人所得稅率，再加上我們為提高這些員工的基本工資所做的投資，將使我們典型的美國非管理層員工的平均到手收入增加數千美元。

When you pair all these with the fact that some 90% of all Amgen staff members globally have held Amgen stock, you can see that the benefits of tax reform will be quite broad.

考慮到安進公司全球約 90% 的員工都持有安進公司的股票，由此可見，稅改帶來的好處將非常廣泛。

Finally, tax reform also provides us with more flexibility for capital deployment. Since 2011, we have invested more than $42 billion in research and development, innovation-based acquisitions and long-term-oriented capital expenditures. We expect to continue making such long-term investments now while also being able to return excess capital to our shareholders in the form of growing dividends and share buybacks.

最後，稅制改革也為我們提供了更大的資本部署彈性。自 2011 年以來，我們已在研發、創新收購和長期資本支出方面投資超過 420 億美元。我們預計未來將繼續進行此類長期投資，同時能夠以不斷增長的股息和股票回購的形式將多餘的資本返還給股東。

Based on our confidence in the long-term outlook for the business, which is enhanced by the benefits of tax reform, we have increased our share repurchase authorization by $10 billion. We expect to retire shares on an accelerated basis of this year, as David will describe shortly. As I've highlighted for you, the benefits of tax reform for our shareholders do not come at the expense of others, but come in addition to the investments that we're making for our staff, the patients we're seeking to serve and our communities.

基於我們對公司長期前景的信心（稅制改革帶來的利多進一步增強了這種信心），我們已將股票回購授權額度增加了 100 億美元。我們預計今年將加快股票回購速度，David稍後會詳細介紹。正如我之前向你們強調的，稅收改革給我們的股東帶來的好處並非以犧牲他人利益為代價，而是在我們為員工、我們所服務的患者以及我們所在的社區進行投資的基礎上增加的。

So to reiterate, we're operating the business well. We've seen that in our financials and you saw it in our successful response to the extraordinary challenge of Hurricane Maria, too. Our in market products are strong. We have attractive assets advancing in the pipeline. And we have a strong balance sheet. Strategically, we're well-positioned to adapt to the growing pressures in the health care environment and to capitalize on consolidation opportunities for our shareholders.

所以再次重申一下，我們的業務運作良好。我們從財務數據中已經看到了這一點，你們也從我們成功應對颶風瑪莉亞這一巨大挑戰中看到了這一點。我們市場上的產品實力很強。我們有一些極具吸引力的資產正在推進中。而且我們的資產負債表非常穩健。從策略角度來看，我們已做好充分準備，適應醫療保健領域日益增長的壓力，並為我們的股東抓住整合機會。

Let me conclude with a word of thanks to our staff around the world for their tireless devotion to our mission. I can assure you, they are focused on serving patients and driving growth in 2018 and beyond.

最後，我要感謝世界各地的員工，感謝他們為實現我們的使命所做的不懈努力。我可以向你保證，他們專注於服務患者，並在 2018 年及以後推動業務成長。

Let's turn to David.

讓我們來看看大衛。

Okay. Thanks, Bob. Before I review our results and guidance, I would like to take a moment to reflect on our performance over the last several years. As Bob mentioned, we entered 2017 as another year which presented significant challenges related to the transition of our portfolio as well as the evolving competitive dynamics of the industry as a whole. In the face of these expected and other not-so-expected challenges, including Hurricane Maria, I'm pleased to report that we delivered positive performance again in 2017. Additionally, with regard to our 5-year goals, we have already delivered or have clear line of sight to delivering on the commitments we established in 2014.

好的。謝謝你，鮑伯。在回顧我們的績效和指導意見之前，我想花點時間回顧一下我們過去幾年的表現。正如鮑伯所提到的那樣，2017 年對我們來說又是充滿挑戰的一年，這不僅與我們投資組合的轉型有關，也與整個產業不斷變化的競爭格局有關。面對這些預料之中的挑戰以及其他一些意料之外的挑戰，包括颶風瑪麗亞，我很高興地報告說，我們在 2017 年再次取得了積極的業績。此外，關於我們的五年目標，我們已經實現了或即將實現我們在 2014 年制定的承諾。

The first goal was to achieve a substantial improvement in our operating efficiency, agility and speed with the resulting outcome of a non-GAAP operating margin between 52% and 54%, representing a 15-point increase at the midpoint. We achieved these objectives starting in 2016, 2 years ahead of our commitment.

第一個目標是大幅提高我們的營運效率、彈性和速度，最終實現非GAAP營業利潤率在52%至54%之間，中點值成長15個百分點。我們從 2016 年開始實現這些目標，比我們承諾的時間提早了 2 年。

Second, in 2017, we delivered the $1.5 billion transformation savings commitment and we'll exceed that goal in 2018.

其次，2017 年我們實現了 15 億美元的轉型節約承諾，2018 年我們將超額完成這個目標。

Third, through our next-generation biomanufacturing capability as well as other efforts to optimize our fixed capital infrastructure, we are on track to meet our 2018 goal of reducing our facility footprint by 23%.

第三，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，我們有望實現 2018 年將設施佔地面積減少 23% 的目標。

Finally, based on today's 2018 guidance, I'm pleased to confirm our expected delivery on the other key objectives of both double-digit non-GAAP EPS growth and providing returns to shareholders of at least 60% of non-GAAP net income on average during the period 2014 to 2018. These commitments are being achieved before benefiting from tax reform, which further enhances Amgen's performance in 2018 and beyond.

最後，根據今天發布的 2018 年業績指引，我很高興地確認，我們預期能夠實現其他關鍵目標，即兩位數的非 GAAP 每股收益增長，以及在 2014 年至 2018 年期間平均為股東提供至少 60% 的非 GAAP 淨收入回報。這些承諾是在稅改帶來的好處之前實現的，這將進一步提升安進公司在 2018 年及以後的表現。

Now let's turn to the fourth quarter financial results on Page 6 of the slide deck. Revenue at $5.8 billion declined 3% year-over-year. This quarter, we saw worldwide product sales at $5.6 billion as unit demand from our growth products largely offset mature product declines.

現在讓我們來看看投影片第 6 頁的第四季財務表現。營收為 58 億美元，年減 3%。本季度，全球產品銷售額達 56 億美元，成長型產品的銷售成長基本上抵銷了成熟型產品的銷售下滑。

We are particularly encouraged by our 10% year-over-year volume growth in markets outside the U.S., reflecting the value of our innovative products in these international markets, many of which have experienced biosimilar competition and portfolio transition for a number of years.

我們尤其感到鼓舞的是，美國以外市場的銷售量年增了 10%，這反映了我們創新產品在這些國際市場的價值，其中許多市場多年來都經歷了生物相似藥的競爭和產品組合的轉型。

Other revenues at $233 million decreased $69 million year-over-year as a result of the milestone payment received in the fourth quarter of 2016 related to the out licensing of AMG 139.

其他收入為 2.33 億美元，年比減少 6,900 萬美元，原因是 2016 年第四季收到了與 AMG 139 對外授權相關的里程碑付款。

Our Q4 non-GAAP operating income at $2.6 billion declined 11% from prior year. Non-GAAP operating margin was 45.9% for the quarter. As previously indicated, our operating expenses reflected the typical underlying fourth quarter pattern. We also experienced a number of additional expenses in the quarter, including $79 million of Hurricane Maria recovery costs, incremental expenses accelerated for tax planning purposes as well as inventory-related costs.

我們第四季非GAAP營業收入為26億美元，比上年同期下降11%。本季非GAAP營業利益率為45.9%。如前所述，我們的營運費用反映了典型的第四季基本模式。本季我們也經歷了一些額外的支出，包括 7,900 萬美元的颶風瑪莉亞災後重建費用、為稅務規劃目的而加速產生的增量支出以及與庫存相關的成本。

Finally, we increased our investments in support of volume-driven growth as we expand activities for our products addressing unmet medical needs in large patient populations, including launch preparations in advance of the upcoming Aimovig launch. These increases were partially offset by continued favorable expense impacts from our transformation initiatives across all operating expense categories and the expiry of the Enbrel residual royalty payment on October 31, 2016.

最後，我們加強了投資力度，以支持銷售驅動型成長，同時擴大了針對大量患者群體未滿足的醫療需求的產品的活動，包括為即將上市的 Aimovig 做準備。這些成長部分被我們轉型計畫在所有營運費用類別中持續帶來的有利費用影響以及 Enbrel 剩餘特許權使用費於 2016 年 10 月 31 日到期所抵消。

Other income and expenses were a net $31 million expense in Q4. This is favorable $171 million on a year-over-year basis. This year-over-year favorability was primarily due to higher interest income, gains in our venture portfolio and gains from investment portfolio rebalancing in the fourth quarter of this year, coupled with favorable compares on both of these items in 2016. A portion of these activities were taken in anticipation of changes in tax and accounting standards effective in 2018.

第四季其他收入和支出淨額為 3,100 萬美元。與上年同期相比，這是一個可觀的1.71億美元。與去年同期相比，這一利好主要歸功於更高的利息收入、創投組合的收益以及今年第四季投資組合再平衡帶來的收益，再加上 2016 年這兩項指標的基數都比較有利。這些活動的一部分是為了因應 2018 年生效的稅務和會計準則的變化而採取的。

The non-GAAP tax rate was 16.6% for the quarter, a 2.1 point improvement versus Q4 2016, reflecting favorable changes in the geographic mix of earnings this year. While not impacting our non-GAAP P&L, we incurred a $6.1 billion charge on our fourth quarter GAAP P&L related to U.S. corporate tax reform, including the repatriation tax and revaluation of net deferred tax liabilities. The repatriation tax will be paid to the U.S. government over an 8-year period.

本季非GAAP稅率為16.6%，比2016年第四季改善了2.1個百分點，反映出今年獲利地域組成發生了有利變化。雖然這不會影響我們的非GAAP損益表，但我們第四季GAAP損益表中產生了與美國企業稅制改革相關的61億美元費用，其中包括匯回稅和淨遞延所得稅負債的重估。遣返稅款將在 8 年內支付給美國政府。

Non-GAAP net income decreased 3%, and non-GAAP earnings per share was flat year-over-year for the fourth quarter. Please find a summary of our 2017 full year results on Page 7 of the presentation.

第四季非GAAP淨利下降3%，非GAAP每股盈餘與去年同期持平。請參閱簡報第 7 頁，以了解我們 2017 年全年業績的摘要。

Our 2017 full year revenues declined 1% to $22.85 billion, while our non-GAAP earnings per share grew 8% to $12.58 per share. For the full year, we saw flat worldwide product sales growth at $21.8 billion. Changes in foreign exchange had a 1% negative impact to total revenue and product sales for the full year on a year-over-year basis.

2017 年全年營收下降 1% 至 228.5 億美元，而非 GAAP 每股收益成長 8% 至每股 12.58 美元。全年來看，全球產品銷售額成長持平，為 218 億美元。外匯變動對全年總收入和產品銷售額造成了同比 1% 的負面影響。

For the full year, non-GAAP operating income at $11.7 billion grew 2% from prior year. Including $146 million of nonrecurring expenses associated with the recovery from Hurricane Maria, our non-GAAP operating margin improved by 1.2 points to 53.5% for the year as we realized the benefits of -- from our ongoing transformation initiatives and the expiry of the Enbrel residual royalty payment.

全年非GAAP營業收入為117億美元，較上年成長2%。在計入與颶風瑪麗亞災後重建相關的 1.46 億美元非經常性支出後，由於我們持續推進轉型計劃以及 Enbrel 剩餘特許權使用費到期，我們的非 GAAP 營業利潤率提高了 1.2 個百分點，達到 53.5%。

On a non-GAAP basis, cost of sales as a percent of product sales increased by 0.2 points to 13.5%, driven primarily by expenses related to Hurricane Maria recovery efforts, unfavorable product mix and other inventory costs offset partially by lower royalties and manufacturing costs efficiencies.

以非GAAP準則計算，銷售成本佔產品銷售額的百分比上升了0.2個百分點，達到13.5%，主要原因是與颶風瑪麗亞災後重建工作相關的支出、不利的產品組合和其他庫存成本，部分被較低的特許權使用費和製造成本效率所抵消。

Research and development decreased 7% year-over-year, driven primarily by lower external business development expenses and lower spending required to support certain later-stage clinical programs.

研發投入年減 7%，主要原因是外部業務拓展費用減少以及支持某些後期臨床項目所需的支出減少。

SG&A expenses decreased 2% year-over-year due to the expiration of the Enbrel residual royalty, partially offset by our increasing investments to drive volume growth in our products, which address unmet needs in large patient populations.

由於 Enbrel 剩餘特許權使用費到期，銷售、一般及行政費用同比下降 2%，但部分被我們為推動產品銷售增長而增加的投資所抵消，這些產品旨在滿足大量患者群體未被滿足的需求。

In total, non-GAAP operating expenses decreased 3% year-over-year to $11.2 billion. Through the end of 2017, overall operating expenses have decreased by approximately $500 million versus 2013 levels. Included within this total is an incremental annual expense of $1.5 billion required to launch and maintain new products, build out new therapeutic areas, advance our biosimilars business and increase our global presence.

總計，非GAAP營運費用年減3%至112億美元。截至 2017 年底，整體營運支出比 2013 年水準減少了約 5 億美元。該總額包含每年新增的 15 億美元支出，用於推出和維護新產品、拓展新的治療領域、推進我們的生物相似藥業務以及擴大我們的全球影響力。

Other income and expenses were favorable by $255 million on a year-over-year basis due to higher interest income on our higher cash balances as well as venture portfolio gains and milestones realized across the course of the year.

由於現金餘額增加帶來的利息收入增加，以及創投組合收益和全年實現的里程碑，其他收入和支出比去年同期減少了 2.55 億美元。

The non-GAAP tax rate was 18% for the full year, down 0.8 points versus 2016. The year-over-year decline was primarily driven by changes in the geographic mix of earnings, offset partially by lower tax benefits from share-based compensation payments.

全年非GAAP稅率為18%，較2016年下降0.8個百分點。年比下降的主要原因是獲利地域組成發生變化，部分被股權激勵支付帶來的稅收優惠減少所抵消。

Turning next to cash flow in the balance sheet on Page 8. For the full year 2017, Amgen continued to demonstrate strong and durable cash flow generation with $10.5 billion in free cash flow versus $9.6 billion last year. This increase was primarily driven by higher operating income and favorable changes in working capital. Cash and investments increased to $41.7 billion. This balance included $3.1 billion in the U.S. and $38.6 billion outside the U.S.

接下來請看資產負債表第 8 頁的現金流量。 2017 年全年，安進持續展現出強勁且持久的現金流產生能力，自由現金流為 105 億美元，而去年為 96 億美元。這一增長主要得益於營業收入增加和營運資本的有利變化。現金及投資增至417億美元。這項餘額包括美國境內的 31 億美元和美國境外的 386 億美元。

Total debt outstanding at year-end totaled $35.3 billion and carries a weighted average interest rate of 3.7% and an average maturity of 12 years.

截至年末，未償債務總額為 353 億美元，加權平均利率為 3.7%，平均期限為 12 年。

In 2017, we deployed $3.1 billion to repurchase 18.5 million shares at an average of $169 per share. At the end of 2017, we had $4.4 billion remaining on our existing share repurchase authorization. Additionally, for 2017, we increased our dividend per share by 15% to $1.15 per quarter with payments totaling $3.4 billion.

2017 年，我們投入 31 億美元回購了 1,850 萬股股票，平均每股價格為 169 美元。截至 2017 年底，我們現有的股票回購授權額度還剩餘 44 億美元。此外，2017 年，我們將每股股利提高了 15%，達到每季 1.15 美元，支付總額為 34 億美元。

Based on our confidence in the future outlook for the enterprise and our continued commitment to our capital allocation strategy, we also announced a 15% increase to the dividend to $1.32 per share for the first quarter of 2018.

基於我們對公司未來前景的信心以及我們對資本配置策略的持續承諾，我們也宣布將 2018 年第一季的股利提高 15%，至每股 1.32 美元。

Turning to the outlook for the business for 2018 on Page 9. 2018 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 to enable us to fully invest from a position of strength. This transformation allows us to deliver industry-leading financial performance while continuing to invest for long-term growth and success.

接下來請看第 9 頁對 2018 年業務的展望。 2018 年對安進來說將是另一個重要的年份，我們將繼續投資於研發管線，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，使我們能夠從強大的地位出發進行全面投資。這一轉型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。

Our 2018 revenue guidance is $21.8 billion to $22.8 billion, and our non-GAAP earnings per share guidance is $12.60 to $13.70 per share. Our non-GAAP tax rate guidance reflecting the impact of tax reform is 14% to 15%, and we expect capital expenditures of approximately $750 million this year.

我們對 2018 年的營收預期為 218 億美元至 228 億美元，非 GAAP 每股盈餘預期為 12.60 美元至 13.70 美元。考慮到稅收改革的影響，我們的非GAAP稅率指引為14%至15%，我們預計今年的資本支出約為7.5億美元。

There are several key assumptions embedded in our outlook that I would like to take a moment to share. First, our revenue guidance reflects both continued positive momentum from our newer products as well as evolving competitive dynamics related to our legacy products. We have important growth opportunities with the inclusion of outcomes data in Repatha's label, our plan to launch new products, including Aimovig and AMJEVITA and the added flexibility enabled by tax reform to use our strong cash flow and balance sheet to drive continued growth of the company. We also embrace the potential challenges, including the possible generic competition to Sensipar, continuing competitive dynamics for Enbrel and expected new competition against Neulasta and Aranesp.

我們的觀點包含幾個關鍵假設，我想花點時間與大家分享。首先，我們的收入預期既反映了新產品持續的積極成長勢頭，也反映了與傳統產品相關的不斷變化的競爭格局。瑞百安 (Repatha) 的標籤中包含療效數據，我們計劃推出新產品（包括 Aimovig 和 AMJEVITA），並且稅收改革帶來了更大的靈活性，使我們能夠利用強勁的現金流和資產負債表來推動公司的持續增長，這些都為我們帶來了重要的增長機會。我們也欣然接受潛在的挑戰，包括 Sensipar 可能面臨的仿製藥競爭、Enbrel 持續的競爭動態以及 Neulasta 和 Aranesp 可能面臨的新競爭。

With regard to Sensipar, although the composition of matter patent expires in March, we were involved in litigation over pediatric exclusivity with the FDA, and separately, over the formulation patent with potential generic competitors. Although we believe in the strength of our position, uncertainty as to the timing of the composition will remain until the outcome of these litigations becomes clear. Also note that historically, the first quarter represents the lowest product sales quarter for the year. For 2018, we expect this pattern to continue. Tony will provide further details related to this in his remarks.

關於 Sensipar，雖然其物質組成專利將於 3 月到期，但我們曾與 FDA 就兒科獨佔權進行訴訟，並分別與潛在的仿製藥競爭對手就製劑專利進行訴訟。儘管我們對自身立場充滿信心，但在這些訴訟的結果明朗之前，和解協議的製定時間仍存在不確定性。另請注意，從歷史數據來看，第一季通常是全年產品銷售額最低的季度。我們預計2018年這一趨勢將持續。托尼將在演講中提供更多相關細節。

With respect to other revenue, for the full year 2018, we expect to see 15% year-over-year growth. The quarterly run rate will be impacted by an unfavorable true-up of a royalty in Q1, offset by incremental milestones in the second half of the year.

至於其他收入，我們預計 2018 年全年將達到 15% 的年成長。季度運行率將受到第一季不利的特許權使用費調整的影響，但將被下半年的增量里程碑所抵消。

From an operating margin perspective, since 2016, we have delivered on our commitment of a non-GAAP operating margin between 52% and 54%. And based on today's guidance, we expect to again operate in this range in 2018 as we continue to invest in our products to drive volume growth in large patient populations. Going forward, we will continue to evaluate incremental investments, including acquisitions to drive growth and maximize shareholder value.

從營業利潤率的角度來看，自 2016 年以來，我們實現了非 GAAP 營業利潤率在 52% 至 54% 之間的承諾。根據今天的指導意見，我們預計 2018 年將繼續保持這一營運水平，因為我們將繼續投資於我們的產品，以推動龐大患者群體的銷售成長。展望未來，我們將繼續評估增量投資，包括收購，以推動成長並最大化股東價值。

The recently passed tax reform legislation provides significant financial flexibility in the form of a globally competitive tax rate and immediate access to the year-end 2017 ex-U. S. cash balance of $39 billion.

最近通過的稅務改革立法提供了重要的財務彈性，包括具有全球競爭力的稅率和立即獲得 2017 年底美國以外地區的稅收收入。美國現金餘額為390億美元。

With regard to 2018 guidance, our non-GAAP tax rate is forecast 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 2018 年的業績指引，我們預期非 GAAP 稅率將在 14% 至 15% 之間。這包括對美國收入徵收 21% 的稅率，以及對美國以外收入徵收 10.5% 的稅率。美國收入。

With regard to capital deployment, our principles over the next several years are as follows: first, we will invest in our business as we continue to expand our pipeline and seek to drive long-term volume growth globally across large patient populations. We will also invest in greater manufacturing capacity to support the volume growth we foresee. For the first time in several decades, tax reform enables us to competitively consider investment in the U.S. As a result, over the next 5 years, we expect to invest approximately $3.5 billion in capital expenditures. Starting in 2018, approximately 75% of that investment will be in the U.S., up from about 50% in recent years.

關於資本部署，我們未來幾年的原則如下：首先，我們將投資於我們的業務，繼續擴大我們的產品線，並尋求在全球範圍內，在龐大的患者群體中推動長期銷售成長。我們還將投資擴大生產能力，以支持我們預期的銷售成長。幾十年來，稅制改革首次使我們能夠更具競爭力地考慮在美國進行投資。因此，在未來5年內，我們預計將在資本支出方面投資約35億美元。從 2018 年開始，大約 75% 的投資將投向美國，高於近年來的約 50%。

As Bob mentioned, a key component of our U.S. capital investment strategy includes a new drug substance manufacturing plant, which will be built using our next-generation biomanufacturing capability. We expect to complete this expansion in about half the time of a conventional plant for approximately 1/3 of the costs.

正如鮑伯所提到的，我們美國資本投資策略的關鍵組成部分是建造一座新的藥物原料生產廠，該廠將利用我們的下一代生物製造能力進行建設。我們預計此次擴建工程將在傳統工廠一半左右的時間內完成，成本約為傳統工廠的三分之一。

In addition to investing internally, we continue to pursue external opportunities to accelerate the growth of our business in our chosen therapeutic areas as well as accelerating our global buildout.

除了內部投資外，我們還將繼續尋求外部機會，以加速我們在所選治療領域的業務成長，並加速我們的全球擴張。

Furthermore, we will invest in additional $300 million in our venture fund. Our venture fund is an important tool to ensuring we are appropriately informed, engaged and invested in cutting-edge advances in science, technology and innovation.

此外，我們將向我們的創投基金追加投資3億美元。我們的創投基金是確保我們能夠充分了解、參與並投資於科學、技術和創新領域尖端進步的重要工具。

Since 2004, we have invested over $0.5 billion in our venture funds. In addition to their scientific importance, these investments have generated returns well above our cost of capital.

自 2004 年以來，我們已在創投基金中投資超過 5 億美元。除了其科學重要性之外，這些投資產生的回報也遠高於我們的資本成本。

Second, we will remain committed to an optimal capital structure in order to minimize our weighted average cost of capital by deploying any excess accumulated capital and fully deploying cash flows going forward. As a first step to accomplishing this objective, we have received board authorization to purchase up to $10 billion of our common stock. This is in addition to the previously approved share repurchase authorization, which remained at $4.4 billion at the end of 2017. Given the scale of excess capital we have to deploy, our plan is to proceed with a Dutch auction equity tender offer consistent with the approach we used successfully in 2011. This tender offer would be for up to $10 billion and would commence as early as next week. Further, we may repurchase up to our authority in the first half of 2018.

其次，我們將繼續致力於實現最佳資本結構，透過部署任何多餘的累積資本和充分利用未來的現金流，最大限度地降低我們的加權平均資本成本。作為實現這一目標的第一步，我們已獲得董事會授權，可以購買最多 100 億美元的普通股。這是在先前已批准的股票回購授權之外的額外撥款，截至 2017 年底，該授權金額仍為 44 億美元。鑑於我們有如此龐大的剩餘資本需要部署，我們的計劃是進行荷蘭式拍賣股權要約收購，這與我們 2011 年成功採用的方法一致。此次要約收購金額最高可達100億美元，最快下週開始。此外，我們可能會在 2018 年上半年回購我們有權回購的股份。

The optimization of our capital structure will result in higher net interest expense in 2018 and beyond as we will have less interest income due to lower cash balances. For 2018, these results in expected other income and expense of $600 million to $700 million net expense.

由於現金餘額減少，利息收入減少，因此優化資本結構將導致 2018 年及以後的淨利息支出增加。2018 年，其他收入和支出預計為 6 億美元至 7 億美元淨支出。

As we deploy our excess capital in the most efficient manner over the next several years, we could find that it is prudent to pay some upcoming debt maturities in cash rather than refinancing in the market. This would translate directly into additional financial flexibility and debt capacity that we could choose to redeploy in the future.

在未來幾年，當我們以最有效的方式部署我們的剩餘資本時，我們可能會發現，用現金支付一些即將到期的債務，而不是在市場上進行再融資，是明智之舉。這將直接轉化為額外的財務靈活性和債務能力，我們可以在未來選擇重新部署這些資金。

Third, we will continue to provide meaningful returns to shareholders through both the previously mentioned share repurchases as well as continued dividend growth.

第三，我們將繼續透過前面提到的股票回購以及持續提高股息，為股東提供有意義的回報。

Finally, today's revenue and non-GAAP EPS guidance ranges are wider than we typically have provided at the start of the year, which is primarily a reflection of a range of Sensipar scenarios in addition to the other ongoing uncertainties outlined earlier. This is important to recognize that our guidance today does not include the impact of potential future M&A activities.

最後，今天公佈的收入和非GAAP每股收益預期範圍比我們通常在年初提供的要寬，這主要反映了Sensipar的各種發展情景，以及前面概述的其他持續存在的不確定性。需要注意的是，我們今天的指導意見並未考慮未來潛在的併購活動的影響。

In summary, we have delivered another year of strong financial results in 2017, and we remain confident in the outlook for Amgen's success in 2018 and beyond.

總而言之，我們在 2017 年又取得了強勁的財務業績，我們對安進在 2018 年及以後的成功前景仍然充滿信心。

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

財務更新到此結束。現在我把電話轉給托尼。

Thank you, David. I'd like to begin with a few comments on our overall performance in 2017, followed by a review of our product performance.

謝謝你，大衛。首先，我想對我們 2017 年的整體表現做一些評論，然後再回顧一下我們的產品表現。

On a full year basis, 2017 sales were in line with 2016, as the growth of our newer products offset the decline in our mature brands. We saw this play out again in quarter 4 as robust volume growth led by Prolia and our recently launched brands offset volume declines in Enbrel, ESAs and NEUPOGEN.

從全年來看，2017 年的銷售額與 2016 年持平，因為我們新產品的成長抵消了成熟品牌的下滑。第四季我們再次看到了這種情況，Prolia 和我們最近推出的品牌的強勁銷量成長抵消了 Enbrel、ESA 和 NEUPOGEN 的銷量下滑。

Our international performance in quarter 4 led by Europe, as David said, was strong with 7% growth, excluding the impact of foreign exchange, driven by volume growth of 10%.

正如大衛所說，我們第四季度的國際業績表現強勁，在歐洲的帶動下，增長了 7%（不計匯率影響），這主要得益於銷量增長了 10%。

The European portfolio has already transitioned to a majority of sales from newer brands, leading to strong volume growth for the overall portfolio. I'm pleased with the execution in 2017. Our team made excellent progress across a number of strategic fronts in building the foundation for long-term volume-driven growth.

歐洲產品組合的銷售額已基本來自新興品牌，從而帶動了整體產品組合的強勁銷售成長。我對2017年的表現很滿意。我們的團隊在多個策略層面取得了卓越的進展，為長期以銷售驅動的成長奠定了基礎。

We drove volume growth across several important brands led by Prolia. We defended Enbrel and several of our mature brands against increasing competition, and we executed some patient-focused life-cycle management strategies. We continue to advance our recently launched products with impressive new clinical data, the most significant, of course, being the Repatha outcomes data as well as 3 new sets of overall survival data, 2 for KYPROLIS and 1 for BLINCYTO. We also began laying the foundation for our next wave of launches. As we prepare for Aimovig, our migraine product in the U.S., and AMGEVITA, our HUMIRA biosimilar in Europe later this year. This will be an exciting milestone as we begin to commercialize our biosimilars in 2018. I am confident that we are well-positioned to capitalize on the opportunities within our portfolio of innovative and differentiated medicines.

我們推動了以Prolia為首的幾個重要品牌的銷售成長。我們捍衛了 Enbrel 和我們幾個成熟品牌免受日益激烈的競爭，並實施了一些以患者為中心的生命週期管理策略。我們持續推動近期推出的產品，並取得了令人矚目的新臨床數據，其中最重要的當然是 Repatha 的結果數據，以及 3 組新的總生存期數據，其中 2 組為 KYPROLIS，1 組為 BLINCYTO。我們也開始為下一波產品發布奠定基礎。今年晚些時候，我們將在美國推出治療偏頭痛的產品 Aimovig，並在歐洲推出 HUMIRA 生物相似藥 AMGEVITA。這將是一個令人興奮的里程碑，因為我們將在 2018 年開始將生物相似藥商業化。我相信，我們已做好充分準備，能夠掌握我們創新且差異化藥物組合中的各種機會。

Turning now to our product performance. Prolia ended 2017 with another impressive quarter of 24% growth year-over-year. On a full year basis, Prolia grew 20%, and as Bob said, now treats over 3.5 million patients globally. In the U.S., we achieved a record number of new patient starts in 2017. After 7 years in the market, this growth of new patient initiation underscores the continuing unmet medical need. Once patients are initiated on Prolia, we have a good track record of sustained repeat injections.

接下來我們來看看產品效能。Prolia 2017 年最後一個季度業績表現亮眼，年增 24%。從全年來看，Prolia 成長了 20%，正如 Bob 所說，現在在全球範圍內治療超過 350 萬名患者。2017 年，我們在美國實現了新患者開診數量的創紀錄成長。經過 7 年的市場檢驗，新患者數量的成長凸顯了持續存在的未被滿足的醫療需求。一旦患者開始接受 Prolia 治療，我們在持續重複注射方面有著良好的記錄。

While this is a great progress, there is still 100 million patients worldwide who suffer from osteoporosis. In the U.S., 1 in every 2 women above 50 will suffer an osteoporotic fracture, so we continue to work to improve both the diagnosis and the treatment of osteoporosis as we grow Prolia's market share within the market.

雖然這是一個巨大的進步，但全世界仍有1億名患者患有骨質疏鬆症。在美國，每 2 名 50 歲以上的女性中就有 1 人會患上骨質疏鬆性骨折，因此，隨著 Prolia 在市場中市場份額的增長，我們將繼續努力改善骨質疏鬆症的診斷和治療。

With its unique profile and through continued and sustained investment, we expect Prolia will remain a very strong growth driver.

憑藉其獨特的優勢，以及持續不斷的投資，我們預計 Prolia 將繼續保持強勁的成長動能。

Turning now onto our oncology brands. KYPROLIS grew 24% year-over-year with strong performance internationally. Uptake in these markets remains robust. Fourth quarter sales in Europe have doubled from the fourth quarter of 2016. In the U.S., KYPROLIS now has 2 compelling sets of overall survival data in both doublet and triplet regimens that demonstrate a 21% reduction in the risk of death versus standard of care in each setting.

接下來，讓我們來看看我們的腫瘤品牌。KYPROLIS年增24%，國際市場表現強勁。這些市場的消費需求依然強勁。歐洲第四季銷售額比 2016 年第四季翻了一番。在美國，KYPROLIS 目前在雙藥和三藥方案中均有 2 組令人信服的總存活期數據，顯示在每種情況下，與標準治療相比，死亡風險降低了 21%。

The FDA just approved adding the impressive overall survival data from the ENDEAVOR study to our label. KYPROLIS plus dexamethasone is the only preferred doublet regimen in the NCCN guidelines. We look forward to the equally impressive overall survival data from ASPIRE being added to our label later this year. These data are, without doubt, differentiators and should reset the treatment paradigm as the new standard of care for relapsed multiple myeloma patients.

FDA剛剛批准將ENDEAVOR研究中令人矚目的總生存期數據添加到我們的標籤中。NCCN 指南中唯一推薦的雙藥聯合方案是 KYPROLIS 加地塞米松。我們期待今年稍後將 ASPIRE 研究中同樣令人印象深刻的整體存活數據添加到我們的標籤中。毫無疑問，這些數據具有區分意義，應該重新定義治療模式，成為復發性多發性骨髓瘤患者新的治療標準。

Our focus message to physicians is pretty clear. Patients who have relapsed will live longer when treated with regimen that include KYPROLIS. And early indications are showing that this is resonating well as KYPROLIS' share of new relapsed or refractive patients continue to improve.

我們向醫生傳達的核心訊息非常明確。復發患者接受包含 KYPROLIS 的治療方案後，壽命會更長。初步跡象表明，這種做法效果顯著，KYPROLIS 在復發或難治性新患者中所佔比例持續提高。

XGEVA grew 4% year-over-year, driven by a combination of volume growth, changes in the inventory and net selling price. We are pleased to begin the year with the FDA's approval to expand the XGEVA label to include the prevention of skeletal-related events in patients with multiple myeloma. This approval was nearly a month ahead of the PDUFA date, and within 5 days of approval, the first multiple myeloma patient received an injection of XGEVA.

XGEVA 年成長 4%，這主要得益於銷售成長、庫存變化和淨售價的綜合推動。我們很高興在新的一年伊始就獲得了 FDA 的批准，擴大了 XGEVA 的適應症範圍，使其包括預防多發性骨髓瘤患者的骨骼相關事件。該批准比 PDUFA 日期提前了近一個月，批准後 5 天內，第一位多發性骨髓瘤患者接受了 XGEVA 注射。

A large portion of the over 100,000 multiple myeloma patients in the U.S. are at risk for bone complications. XGEVA can help these patients as many of them cannot effectively be treated with zoledronic acid due to renal insufficiency. CMS has recognized this issue and has designated that XGEVA as a noble therapy for these patients. This is another example of our life-cycle management strategy and investment in volume-driven growth.

美國超過 10 萬名多發性骨髓瘤患者中，很大一部分人面臨骨骼併發症的風險。由於腎功能不全，許多患者無法有效使用唑來膦酸治療，因此 XGEVA 可以幫助這些患者。美國醫療保險和醫療補助服務中心（CMS）已經意識到這個問題，並將XGEVA指定為這些患者的有效療法。這是我們的生命週期管理策略和對銷售驅動成長的投資的又一例證。

Neulasta sales were flat year-over-year as we continue to see low-single-digit decline in the use of myelosuppressive chemotherapy regimens due to growth in new and less toxic therapies. Onpro continues to gain traction, and we exited 2017 slightly above 60% of U.S. Neulasta units sold. Its compelling value proposition for patients and the health care system is clear. It delivers better adherence to therapy, lower rates of febrile neutropenia and hospitalization and more convenience for patients and oncology practices. Our patent-protected Onpro will be an important point of differentiation in the marketplace against future potential competition.

由於新的、毒性較小的療法的出現，骨髓抑制性化療方案的使用量持續出現個位數百分比的下降，Neulasta 的銷售額與去年同期持平。Onpro 繼續獲得市場認可，到 2017 年底，我們在美國 Neulasta 銷量中所佔份額略高於 60%。它對患者和醫療保健系統具有顯而易見的強大價值。它能提高治療依從性，降低發燒性嗜中性白血球減少症和住院率，並為患者和腫瘤科診療帶來更多便利。我們擁有專利保護的 Onpro 將成為我們在市場上對抗未來潛在競爭的重要差異化優勢。

On the topic of potential new competition to Neulasta in the U.S., we know there continue to be a serious amount of questions about will the competitors will be announcing their arrival in the market for some years now will be able to succeed with regulators and in the courts such that they could finally come to market in the second half of 2018. If they do arrive, we will be ready for them.

關於美國市場上可能出現對 Neulasta 構成威脅的新競爭對手，我們知道，多年來一直存在著許多疑問，例如這些競爭對手是否會宣布進入市場，能否在監管機構和法庭上取得成功，最終在 2018 年下半年進入市場。如果他們真的來了，我們會準備好迎接他們。

With Neupogen, the impact of short-acting biosimilars in the fourth quarter were consistent with prior trends as we exited 2017 with nearly 40% unit share of the short-acting market. We continue to maintain pricing discipline since the entry of competitors.

就 Neupogen 而言，第四季度短效生物相似藥的影響與先前的趨勢一致，我們在 2017 年末已佔據短效市場近 40% 的份額。自從競爭對手進入市場以來，我們一直堅持價格紀律。

Now turning to Enbrel, which declined 13% year-over-year. Underlying volume demand was in line with prescription trends in the fourth quarter. Segment growth in rheumatology and dermatology as well as changes in Enbrel volume share across each segment were in line with prior quarters. As I told you last quarter, maintaining Enbrel's strong forming position and patient access is resulting in a small decline in net selling price. We expect the fourth quarter trends for both unit demand and net selling price to continue into 2018.

現在來看恩利（Enbrel），其年減了 13%。第四季度，潛在銷售需求與處方趨勢一致。風濕病和皮膚病領域的細分市場成長以及 Enbrel 在各個細分市場的銷售份額變化與前幾季一致。正如我上個季度告訴你們的那樣，維持 Enbrel 的強勁市場地位和患者可及性，導致淨售價略有下降。我們預計第四季的單位需求和淨售價趨勢將延續到 2018 年。

You'll also recall the first quarter last year was the lowest quarter of 2017 as insurance reverifications and patient deductibles reset for the new calendar year. We expect to experience some of the dynamics this year, and therefore, expect Enbrel's first quarter to be the lowest sales for 2018, representing approximately 20% of full year 2018 sales.

您可能還記得，去年第一季是 2017 年全年最低的季度，因為保險重新核實和病患自付額在新日曆年重置。我們預計今年會經歷一些變化，因此預計 Enbrel 2018 年第一季的銷售額將是全年最低的，約佔 2018 年全年銷售額的 20%。

Critical to our strategy with Enbrel is the ongoing pursuit of innovative ways to enhance patient experience and to differentiate our product. The Enbrel Mini with AutoTouch was recently launched along with a new low-pain formulation. This is a multi-use device specifically designed to be used with ease by rheumatoid arthritis patients.

對於我們的 Enbrel 策略而言，關鍵在於不斷尋求創新方法來提升患者體驗並使我們的產品脫穎而出。Enbrel Mini with AutoTouch 近期上市，同時也推出了新的低痛配方。這是一款多功能設備，專為類風濕性關節炎患者輕鬆使用而設計。

Patient feedback has been very positive on these new innovations, and we're also very proud of the positive environmental benefit of this reusable auto-injector.

患者對這些創新技術的回饋非常積極，我們也為這種可重複使用的自動注射器帶來的正面環境效益感到非常自豪。

Switching now to our ESA portfolio. Slide 21 shows the 2017 composition of our ESA business. Aranesp declined by about 7% on a year-over-year basis with lower unit demand, favorable prior year adjustments and unfavorable foreign rates. With EPOGEN, the underlying business remained relatively stable with the primary driver being lower net selling price as a result of our extended supply agreement with DaVita until 2022.

現在切換到我們的ESA產品組合。第 21 張幻燈片顯示了我們 ESA 業務在 2017 年的組成。由於單位需求下降、上年有利調整以及不利的外匯匯率，Aranesp 年減約 7%。EPOGEN 的基礎業務保持相對穩定，主要驅動因素是由於我們與 DaVita 的供應協議延長至 2022 年，導致淨售價降低。

Over the last couple of years, we have grown our U.S. Aranesp business by converting the medium-sized and independent dialysis centers from EPOGEN to Aranesp. However, we are aware that a long-acting competitor has recently extended their product offering to these dialysis customers. So we expect to lose some of those business as early as this quarter. We're also preparing to compete with the potential short-acting biosimilar in all customer segments, including hospitals and clinics, if and when such a biosimilar is approved by the FDA.

在過去的幾年裡，我們將中型和獨立的透析中心從 EPOGEN 轉換為 Aranesp，發展壯大了我們在美國的 Aranesp 業務。然而，我們注意到，一家長期競爭對手最近已將其產品供應範圍擴大到這些透析客戶。因此，我們預計最早在本季就會失去部分業務。如果FDA批准某種短效生物相似藥，我們也準備在所有客戶群（包括醫院和診所）中與這種潛在的短效生物相似藥競爭。

Our long track record of safety, efficacy and reliable safety -- supply rather, and reliable supply, is a competitive advantage that Amgen has always had.

安進公司長期以來在安全性、有效性和可靠的安全（或更確切地說是供應，以及可靠的供應）方面擁有良好的記錄，這是安進一直擁有的競爭優勢。

Turning now to calcimimimeticsc, beginning with Parsabiv. We continue to launch Parsabiv in new markets throughout the world. This includes launching in the U.S. last month. As the head-to-head clinical data showed, Parsabiv demonstrated a greater level of efficacy when compared to Sensipar. Since the product is administered in the patient's existing IV line during dialysis, it puts control into the hands of the health care provider, which could drive an improved level of adherence. Nephrologists continue to be positive and are excited about having the product available.

現在轉向鈣調蛋白，從 Parsabiv 開始。我們將繼續在全球各地的新市場推出 Parsabiv 產品。這包括上個月在美國的上市。臨床對比數據顯示，與Sensipar相比，Parsabiv表現出更高的療效。由於該產品是在透析期間透過患者現有的靜脈輸液管給藥，因此控制權掌握在醫療保健提供者手中，這可能會提高患者的依從性。腎臟科醫生們依然持樂觀態度，並對該產品的上市感到興奮。

As David mentioned, the 2018 outlook for Sensipar is somewhat uncertain given the ongoing litigations. It is, of course, conceivable that competitors may be able to bring generic products to market at some point in 2018, although we believe we have strong litigation positions.

正如大衛所提到的，鑑於正在進行的訴訟，Sensipar 2018 年的前景有些不明朗。當然，競爭對手有可能在 2018 年的某個時候將仿製藥推向市場，儘管我們相信我們在訴訟方面擁有強大的優勢。

With Repatha, we continue to execute competitively, maintaining a majority share on a global basis. We were very excited to exit 2017 with the expedited approval by the FDA of the Repatha outcomes data. This is a very important milestone for Repatha and its potential to help cardiovascular patients with high risk of heart attacks and strokes.

憑藉 Repatha，我們持續保持競爭力，在全球範圍內維持多數市場份額。2017 年末，我們非常高興地看到 Repatha 的療效數據獲得了 FDA 的快速批准。對於Repatha及其幫助心血管疾病高風險族群（心臟病和中風）的潛力而言，這是一個非常重要的里程碑。

Our team can now, for the first time, speak directly to the benefits of treating patients with Repatha and its ability to reduce the risk of heart attack by 27% and stroke by 21%, as well as further event reductions after the first year of treatment.

我們的團隊現在可以首次直接談論使用 Repatha 治療患者的益處，以及它能夠將心臟病發作的風險降低 27%，將中風的風險降低 21%，並在治療的第一年後進一步降低事件發生率。

Our sales teams were trained and in the field shortly after the approval and are receiving positive feedback from physicians. It's still early days since the approval but signs are pointing in the right direction with NBRx gains.

我們的銷售團隊在獲得批准後不久就接受了培訓並投入工作中，並收到了醫生們的正面回饋。雖然獲批時間尚短，但NBRx的上漲表明情況正在朝著正確的方向發展。

We do, however, expect quarter 1 sales to be relatively flat sequentially as Repatha faces similar dynamic with Enbrel related to insurance reverification and resetting of patient out-of-pocket costs in the first quarter.

不過，我們預計第一季銷售額將與上一季持平，因為 Repatha 和 Enbrel 在第一季面臨類似的保險重新核實和患者自付費用重置的動態。

We continue to work with payers to improve patient access and are making progress. Our priority remains reaching the large population of high-risk cardiovascular patients.

我們繼續與支付方合作，改善患者就醫途徑，並正在取得進展。我們的首要任務仍然是接觸到大量高風險心血管疾病患者。

The cost to society of not treating these patients is unacceptable, and we are looking at all options to improve access for appropriate high-risk patients. We also look forward to having the Repatha labels updated with the outcomes data outside the U.S. soon. So 2018 will be an important year as we continue our transition of our portfolio and lay the groundwork for sustainable, volume-driven long-term growth.

不治療這些患者對社會造成的損失是不可接受的，我們正在研究所有方案，以改善合適的、高風險患者的就醫途徑。我們也期待 Repatha 的標籤能盡快更新美國以外地區的療效數據。因此，2018 年將是重要的一年，我們將繼續推動產品組合轉型，為可持續的、以銷售為導向的長期成長奠定基礎。

In closing, I'd like to thank our team for the impressive and competitive execution in 2017. I look forward to facing with them the challenges, and more importantly, the opportunities that 2018 will bring in our innovative medicines to grievously ill patients around the world.

最後，我要感謝我們的團隊在 2017 年取得的令人印象深刻且極具競爭力的成績。我期待與他們一起迎接挑戰，更重要的是，迎接2018年將帶來的機遇，將我們的創新藥物帶給世界各地的重症患者。

Let me now pass you to Sean. Sean?

現在我把麥克風交給肖恩。肖恩？

Thanks, Tony. Good afternoon. I'll begin with cardiovascular. With the recent inclusion of our cardiovascular outcomes data in the U.S. label, Repatha is the first and only PCSK9 inhibitor approved to prevent heart attack, stroke and coronary revascularization in adults with established cardiovascular disease. We now have numerous professional guidelines and treatment pathways along with the FDA all recognizing the ability of Repatha to reduce life-changing events of stroke and heart attack, and we expect payers to take an increasingly more thoughtful approach to patient access.

謝謝你，托尼。午安.我先從心血管方面說起。隨著我們最近將心血管結果數據納入美國標籤，Repatha 成為第一個也是唯一一個獲準用於預防已確診心血管疾病的成年人發生心臟病、中風和冠狀動脈血運重建的 PCSK9 抑制劑。現在，包括美國食品藥物管理局 (FDA) 在內的眾多專業指南和治療方案都認可了 Repatha 能夠減少中風和心臟病發作等改變生活的事件，我們預計支付方將採取越來越周全的方式來保障患者的用藥。

In inflammation, we began dozing tezepelumab in our 52-week Phase III study in over 1,000 patients with severe uncontrolled asthma in our collaboration with AstraZeneca. I would note that the primary endpoint in our Phase III program is the same as the one we reported for the Phase IIb study, where we demonstrated efficacy across a broad spectrum of patient types.

在發炎方面，我們與阿斯特捷利康合作，在一項為期 52 週的 III 期研究中，開始對 1000 多名患有嚴重未控制氣喘的患者使用 tezepelumab 進行鎮靜治療。我想指出，我們 III 期計畫的主要終點與我們在 IIb 期研究中報告的終點相同，在 IIb 期研究中，我們證明了該療法對各種類型的患者都有效。

We've also reacquired our IL-15 antagonist antibody, AMG 714, after our Celimmune collaboration generated intriguing Phase IIa data in severe celiac disease. We'll be discussing the data and a potential path forward with regulators as there are not clearly established end points for registration in this area.

在我們與 Celimmune 合作進行的 IL-15 拮抗劑抗體 AMG 714 在重度乳糜瀉的 IIa 期臨床試驗中獲得令人振奮的數據後，我們又重新獲得了該抗體。我們將與監管機構討論相關數據和可能的後續方案，因為該領域註冊的終點尚未明確。

In neuroscience, we and Novartis are looking forward to the FDA PDUFA date for Aimovig in May. I'm often asked about our approach with the CGRP receptor antibody versus the ligand and how it differentiates. We targeted the receptor because we wanted the most potent antibody we could develop to reduce the amount of antibody required for maximal clinical effect, and our expertise in antibody discovery and development allowed us to succeed at this. With Aimovig, we can elicit maximal CGRP inhibition with a relatively low dose. We've submitted 70 and 140 milligram per month to regulators compared with higher doses for the ligand sequestrants. This translates into monthly subcutaneous self-administration with a pen-type autoinjector that uniquely does not require loading doses, which we believe will be much more attractive to patients and providers. Also, as we've seen in other diseases, having mechanistic choices is an attractive option for physicians and patients, and Aimovig is the first and only CGRP receptor antibody ever introduced to the clinic.

在神經科學領域，我們和諾華公司都期待FDA在5月公佈Aimovig的PDUFA核准日期。我常被問到我們使用 CGRP 受體抗體與配體的方法有何不同。我們之所以選擇該受體作為靶點，是因為我們想要開發出最有效的抗體，以減少達到最大臨床效果所需的抗體數量，而我們在抗體發現和開發方面的專業知識使我們能夠成功做到這一點。使用 Aimovig，我們可以用相對較低的劑量達到最大的 CGRP 抑制效果。我們向監管機構提交了每月 70 毫克和 140 毫克的配體螯合劑，而配體螯合劑的劑量則更高。這意味著每月使用筆式自動注射器進行皮下自我注射，這種注射器無需負荷劑量，我們相信這將對患者和醫療服務提供者更具吸引力。此外，正如我們在其他疾病中所看到的，有特定機制的選擇對醫生和患者來說都是一個有吸引力的選擇，而 Aimovig 是第一個也是唯一一個被引入臨床的 CGRP 受體抗體。

We have also executed a differentiated development program with Aimovig with a dedicated cardiovascular treadmill study in patients with stable angina, and most recently demonstrated efficacy in a large study of patients with multiple prophylactic treatment failures who were not only considered difficult to treat but also have virtually no other treatment option.

我們還針對 Aimovig 開展了一項差異化的研發計劃，對患有穩定型心絞痛的患者進行了專門的心血管運動平板試驗研究，最近在一項針對多次預防性治療失敗患者的大型研究中證明了其療效，這些患者不僅被認為難以治療，而且幾乎沒有其他治療選擇。

Turning to oncology in KYPROLIS, the U.S. prescribing information was recently updated with the overall survival data from ENDEAVOR, which also received a positive opinion in Europe. The ASPIRE overall survival data have also been submitted in both regions. Having survival data from 2 studies establishes KYPROLIS as the new standard of care for relapsed multiple myeloma.

KYPROLIS 的腫瘤治療方面，美國處方資訊最近更新了 ENDEAVOR 研究的總存活期數據，該研究在歐洲也獲得了正面評價。兩個地區的 ASPIRE 總存活期數據也已提交。兩項研究的存活數據表明，KYPROLIS 已成為復發性多發性骨髓瘤的新標準療法。

XGEVA was recently approved for the prevention of skeletal-related events in multiple myeloma for patients in the U.S. As Tony mentioned, this is an important advance as myeloma patients often develop renal insufficiency, which hinders treatment with bisphosphonates, putting them at increased risk for bone complications.

XGEVA 最近在美國獲準用於預防多發性骨髓瘤患者的骨骼相關事件。正如 Tony 所提到的，這是一個重要的進展，因為骨髓瘤患者經常出現腎功能不全，這會阻礙雙磷酸鹽治療，使他們面臨更高的骨骼併發症風險。

XGEVA is not cleared through the kidneys and provides an important new treatment option. We also received the results of the Phase III D-CARE study with XGEVA. D-CARE was initiated in 2010 with the hypothesis that treatment with denosumab could potentially delay cancer recurrence in bone or other tissues in patients with early-stage breast cancer. D-CARE explored an investigational dosing schedule of denosumab as adjuvant treatment for women in high-risk early breast cancer stages, receiving standard of care neoadjuvant or adjuvant cancer therapy. Unfortunately, the trial was neutral and did not meet its primary endpoint of bone metastasis-free survival. Adverse events observed in patients treated with XGEVA were similar to the known safety profile.

XGEVA 不經腎臟清除，提供了重要的全新治療選擇。我們也收到了 XGEVA 的 III 期 D-CARE 研究結果。D-CARE 於 2010 年啟動，其假設是使用地諾單抗治療有可能延緩早期乳癌患者骨骼或其他組織的癌症復發。D-CARE 研究了地諾單抗作為高風險早期乳癌女性輔助治療的試驗性給藥方案，這些女性正在接受標準的新輔助或輔助癌症治療。可惜的是，該試驗結果為陰性，並未達到主要終點－無骨轉移存活期。使用 XGEVA 治療的患者中觀察到的不良事件與已知的安全性特徵相似。

Detailed results will be submitted to a future medical conference and/or publication. I'd like to stress, this result has no bearing on the approved and well-established indication for the prevention of skeletal-related events in breast cancer patients with bone metastasis.

詳細結果將提交給未來的醫學會議和/或出版物。我想強調的是，這一結果與已批准且已確立的用於預防乳癌骨轉移患者骨骼相關事件的適應症無關。

Finally, in other European regulatory news, Nplate received a positive opinion in Europe, recommending approval for the treatment of chronic ITP for patients 1 year of age or older or refractory to other treatments. And BLINCYTO received a CHMP-positive opinion to include overall survival data from the Phase III TOWER trial, supporting conversion from conditional to full market authorization in the current indication.

最後，在其他歐洲監管新聞方面，Nplate 在歐洲獲得了積極意見，建議批准其用於治療 1 歲或以上或對其他治療無效的慢性 ITP 患者。BLINCYTO 獲得了 CHMP 的積極意見，納入了 III 期 TOWER 試驗的總生存期數據，支持將當前適應症的有條件上市許可轉換為完全上市許可。

We had the opportunity to provide a detailed update on our oncology franchise and our excitement around our differentiated approach to immuno-oncology at the American Society of Hematology meeting in December. There, we announced that we developed a half-life extended BiTE format, and then moved 3 of these into the clinic with several others in preclinical development. We now have 7 BiTE programs in the clinic and expect data generated in the next 18 to 24 months in both hematologic and solid tumors to provide key insights on the clinical utility of this platform.

在 12 月舉行的美國血液學會會議上，我們有機會詳細介紹了我們的腫瘤產品線，並表達了我們對差異化免疫腫瘤學方法的興奮。在那裡，我們宣布我們開發了半衰期延長的 BiTE 格式，然後將其中 3 種推進臨床，另有幾種處於臨床前開發階段。目前我們有 7 個 BiTE 項目在臨床應用，預計未來 18 至 24 個月內，血液腫瘤和實體腫瘤產生的數據將為該平台的臨床應用提供關鍵見解。

We're in a unique position to evaluate both BiTE and CAR T programs, in some cases, directed against the same antigen and, in fact, we have an IND in place for our first CAR T from the Gilead Kite collaboration. We'll begin dosing patients a bit later this year.

我們處於獨特的地位，可以評估 BiTE 和 CAR T 項目，在某些情況下，這些項目針對的是相同的抗原，事實上，我們已經為與 Gilead Kite 合作的第一個 CAR T 申請了 IND。今年稍後我們會開始給患者用藥。

We also highlighted our commitment to multiple myeloma, specifically with our MCL-1 inhibitor, 2 BCMA-targeted BiTEs and a BCMA antibody drug conjugate, all moving through Phase I, and our bispecific T-cell engaging antibody directed against CD38, licensed from Xencor, which will begin dosing this year as well.

我們也重點介紹了我們對多發性骨髓瘤的投入，特別是我們的 MCL-1 抑制劑、2 種 BCMA 靶向 BiTE 和一種 BCMA 抗體藥物偶聯物，它們都已進入 I 期臨床試驗；此外，我們從 Xencor 獲得許可的針對 CD38 的雙特異性 T 細胞接合抗體也將於今年開始給藥。

In our bone franchise, UCB recently submitted Evenity in Europe for the treatment of osteoporosis in postmenopausal women and in men having increased risk of fracture. We continue to systematically reevaluate all registrational and clinical trial data to ensure we have the most comprehensive understanding of the cardiovascular safety signals observed in the active comparator ARCH study. And we will work in close collaboration with the FDA toward our resubmission under the complete response letter timelines in the U.S. later this year.

在我們的骨骼產品線中，UCB 最近向歐洲提交了 Evenity，用於治療停經後婦女和骨折風險增加的男性的骨質疏鬆症。我們將繼續系統地重新評估所有註冊和臨床試驗數據，以確保我們對在活性對照 ARCH 研究中觀察到的心血管安全性訊號有最全面的了解。我們將與美國食品藥物管理局 (FDA) 密切合作，爭取在今年稍後按照美國完整回覆函的時間表重新提交申請。

Lastly, we continue to make good progress on our biosimilars with the European approval of our biosimilar Avastin. We also expect Phase III rheumatoid arthritis data from ABP 710, our biosimilar Remicade, later in the year.

最後，我們的生物相似藥持續取得良好進展，我們的生物相似藥阿瓦斯汀已獲得歐洲批准。我們也預計將在今年稍後獲得 ABP 710（我們的生物相似藥 Remicade）的 III 期類風濕性關節炎數據。

In closing, I'd like to thank all of my colleagues at Amgen for another year of successfully advancing programs for the benefit of patients. Bob?

最後，我要感謝安進公司的所有同事，感謝他們又一年成功地推動各項計劃，造福病人。鮑伯？

Okay. Thanks. Skinner, let's go straight to the questions and could you please remind our callers of the procedure for asking questions and maybe just give them a heads up that we'll go longer than usual because, as I advertised at the beginning of my remarks, we were going to be a little bit longer in our prepared portion, so we'll stay and take the questions from the analysts, Skinner. Let's jump to it.

好的。謝謝。史金納，我們直接進入問答環節吧。請您提醒聽眾提問的流程，也請您提前告知大家，今天的節目會比平常長一些，因為正如我在發言開始時所說，我們準備的部分會稍微長一些。所以，史金納，我們會留下來回答分析師們的問題。讓我們直接進入正題。

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(Operator Instructions) And our first question comes from Robyn Karnauskas from Citigroup.

（操作員說明）我們的第一個問題來自花旗集團的 Robyn Karnauskas。

So can you really be clear about what percentage of your guidance was influenced by biosimilars? What was the real impact? And for Sean, when you think about your pipeline and really broad and (inaudible) the options are available. When you think about the probably adjusted value today in your pipeline, can you help us understand how to value that pipeline to offset the biosimilar impact?

那麼，您能否明確說明您的指導意見中有多少百分比受到了生物相似藥的影響？實際影響是什麼？對於肖恩來說，當你認真思考你的頻道，並且真正廣泛地考慮（聽不清楚）時，你會發現有很多選擇。當您考慮您產品線目前可能調整後的價值時，您能否幫助我們了解如何評估該產品線的價值，以抵消生物相似藥的影響？

Okay. Robyn, we're having a little bit difficulty hearing you, but I think, your first question was -- sounded like it was one that we should ask David to address. You were asking how much of the wide range in revenue guidance was attributable to biosimilars. I think, David tried to make it clear that a lot of it was related to Sensipar, but go ahead, David, and address this.

好的。羅賓，我們聽不太清楚你說話，但我認為，你的第一個問題——聽起來像是我們應該請大衛來回答的問題。您問的是，營收預期範圍如此之大，其中有多少是由於生物類似藥造成的。我認為，David 已經試圖表明很多事情都與 Sensipar 有關，但 David，請繼續解釋。

Yes. Right. So if you look at the guidance that we offered, it's obviously much larger than we would typically have, about double what we would have had at the beginning of the year. And certainly, a large portion of that is attributable to the uncertainty around the launch, the competitive launches that may occur this year from Sensipar. So that's the primary driver of a broader guidance than we typically would offer.

是的。正確的。所以，如果你看一下我們提供的指導意見，很明顯，它比我們通常的規模要大得多，大約是年初的兩倍。當然，這很大程度上是由於上市的不確定性，以及 Sensipar 今年可能推出的競爭性產品所致。因此，這是我們提供比通常情況下更廣泛指導的主要驅動因素。

And again, Robyn, it wasn't clear what you're trying to get out with your question about the pipeline, but Sean, go ahead.

羅賓，你關於管道的問題到底想表達什麼，我還是不太明白。肖恩，你繼續。

Yes. I mean, I think, it had to do with the value of the pipeline versus the, obviously, the pressures we're facing on some of our legacy products as they go through the portfolio transition. I would just say that you're right, Robyn, we do have a very broad and deep capability these days. It's the best it's ever been at Amgen, in my opinion. And I think that what you can observe is that across the key therapeutic areas that we're focusing in, we have a lot of really exciting opportunities. And I think that we can expect to see the same sort of productivity with respect to advancing the pipeline in over the next 5 years that we've observed over the last 5 years.

是的。我的意思是，我認為這與產品線的價值有關，而顯然，我們的一些傳統產品在進行產品組合轉型時正面臨壓力。我只想說，你說得對，羅賓，我們現在的確擁有非常廣泛和深入的能力。在我看來，這是安進公司有史以來最好的時期。我認為大家可以觀察到，在我們關注的關鍵治療領域，我們有許多非常令人興奮的機會。我認為，在未來 5 年裡，我們在推進管道建設方面可以期待看到與過去 5 年一樣的生產力。

Our next question comes from Chris Raymond from Piper Jaffray.

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

So I have a question that, I think, is mostly related to Enbrel. There's been some dust kicked up recently with regard to payers and PBMs instituting these some so-called copay accumulators, which don't allow copay assistance and other patient assistance to count against deductibles and out-of-pocket maximums. From what I've read, you guys have seemed to take in a really strong stance against this with some specific countermeasures, and you're working to ensure that patients would actually benefit the patient. But I'm just hoping if you could maybe put some brackets around the ranges of uptake that this phenomenon could have this year? And what other specific countermeasures you could take if your current measures don't work?

所以我有一個問題，我認為這個問題主要與恩利（Enbrel）有關。最近，支付方和藥品福利管理機構（PBM）實施了一些所謂的共付額累積機制，引起了一些爭議。這些機制不允許共付額援助和其他患者援助計入免賠額和自付費用上限。從我讀到的內容來看，你們似乎對此採取了非常強硬的立場，並採取了一些具體的應對措施，你們正在努力確保患者能夠真正受益。但我只是希望您能不能大致估算一下今年這種現象的接受度範圍？如果目前的措施無效，您還可以採取哪些其他具體的應對措施？

It's Tony. So let me respond to that one. You are correct that Amgen has made it pretty clear that we disagree with the concept of the accumulator. That fundamentally, our systems is, to assist patients who can't afford their copays, that the agreements and contracts we have with these organizations is around making sure patients get access. So we put that in writing and made it clear to people. As I look at quarter 1, I see a minimal impact to our Enbrel business because of these programs.

是托尼。讓我來回答這個問題。您說得對，安進公司已經非常明確地表示，我們不同意蓄能器的概念。從根本上說，我們的系統是為了幫助那些負擔不起自付費用的患者，我們與這些組織簽訂的協議和合約是為了確保患者能夠獲得醫療服務。所以我們把這些寫下來，讓大家明白了。展望第一季度，我認為這些項目對我們的恩利業務影響甚微。

And our next question comes from Geoffrey Porges from Leerink Partners.

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

Perhaps, David, could you comment a little bit on your balance sheet. You sort of alluded to the fact that there may be some moving parts on your balance sheet. And obviously, you're bringing a lot of cash back. You're effectively unlevered despite the fact you have significant debt given your cash position. As you look at opportunities across the industry, Bob has been sort of quite outspoken about the need for consolidation, I'm just wondering, what kind of leverage would you be comfortable with given the visibility you have to the future cash flow? Would you be willing to sort of go up on a net basis to several times your EBITDA?

大衛，或許你可以稍微談談你的資產負債表。你似乎暗示過你的資產負債表上可能有一些變動項目。顯然，你帶回了很多現金。儘管你負債累累，但考慮到你的現金狀況，你實際上並沒有槓桿。鑑於您對未來現金流的可見性，鮑伯一直以來都比較直言不諱地談到整合的必要性，我只是想知道，您會接受什麼樣的槓桿率？您是否願意將淨收益提高到 EBITDA 的數倍？

Yes, Jeff. So I guess, the way I would think about the balance sheet going forward is I would look at how we've managed the balance sheet over these last several years, and we did that to optimize our -- and get the lowest weighted average cost of capital. And we did that without consideration of the offshore cash balances. So we set our leverage and it's varied over the last several years out of peak, after Onyx, and then it's come down since that time. And I think it would be fair to assume that on a steady-state basis, we would think about those kinds of balance sheet leverage ratios to be similar to what we've had in the past. Now what I would say is that in the very near term, given the fact that we have such a large amount of capital that we'll be deploying, it's quite possible, as I mentioned in my comments, that we would pay some down -- some debt in the interim, but that wouldn't be mistaken to be where we think the ideal capital structure would be. So I would refer, again, without reference to the cash we've been carrying, but just look at our leverage over these last several years. I think it's a good sort of guidepost for how we'll manage the business going forward.

是的，傑夫。所以我想，展望未來，我會這樣看待資產負債表：我會回顧過去幾年我們是如何管理資產負債表的，我們這樣做是為了優化我們的——並獲得最低的加權平均資本成本。而我們當時並沒有考慮海外現金餘額。所以我們設定了槓桿率，在 Onyx 之後，槓桿率在過去幾年裡有所波動，從峰值開始下降。我認為可以合理地假設，在穩定狀態下，我們會認為這類資產負債表槓桿率與我們過去的情況類似。現在我想說的是，鑑於我們近期將要投入如此大量的資金，正如我在評論中提到的，我們很有可能會償還一些債務，但這並非我們認為理想的資本結構。所以，我再次強調，暫且不考慮我們持有的現金，而是看看我們過去幾年的槓桿率。我認為這可以作為我們未來如何管理業務的一個很好的指導方針。

Our next question comes from Ying Huang from Bank of America Merrill Lynch.

下一個問題來自美國銀行美林證券的黃穎。

Just a question for David. Can you comment whether the guided 14% to 15% tax rate for 2018 is actually also the way we should think about the long-term tax rate? And then, in 4Q '17, your OpEx went a bit higher than usual, do you expect the margin, the pretax operating margin, to go back to the level you saw in the first 3 quarters in 2017 for the 2018 period?

問大衛一個問題。您能否評論一下，2018 年 14% 至 15% 的指導稅率是否也是我們應該考慮的長期稅率？然後，在 2017 年第四季度，您的營運支出略高於往常，您預計 2018 年的稅前營業利潤率會回到 2017 年前三個季度的水平嗎？

Sure. Yes. So in terms of the tax rate, post 2018, what I would say is that if you look at our guide for this year on a non-GAAP basis, that 14% to 15%, our preliminary analysis would suggest to us that, that would be a reasonable outlook for the period post 2018. And I use some words preliminary and that sort of thing because it's still evolving, but I think, as a starting point, I think, it's reasonable to think about that as a steady-state type level of tax rate going forward. And then, in terms of -- you're correct, as I tried to articulate, if you look at our operating expense performance in Q4, basically, we typically have -- as you know, we typically have the highest level of expense is in Q4 on an annual basis. And to the extent we had expenses beyond that this past year in Q4 of '17, those were basically and entirely one-time type expenses that we wouldn't expect to be recurring. And that was related, as I said, to the hurricane costs, which were extraordinary and one-time, as well as based on the fact that we had, last year, a 35% tax rate versus taxes this year of 21% in the U.S. We looked at choices we might make around the timing of such discretionary expenses and time them into the period where we got a benefit from a tax perspective. So with all of that, you go to 2018, as I said, our guidance would suggest to you and to us that we expect to operate in the 52% to 54% range again this year. And I think you can expect the quarter-by-quarter patterns of margins and expenses to be quite consistent with what you've seen if you look at an average over the last several years.

當然。是的。因此，就 2018 年以後的稅率而言，我想說的是，如果您看一下我們今年的非 GAAP 指導價，即 14% 至 15%，我們的初步分析表明，這將是 2018 年以後時期的合理展望。我之所以用「初步的」之類的詞語，是因為它仍在發展中，但我認為，作為一個起點，將其視為未來穩定的稅率水平是合理的。然後，就——你說得對，正如我試圖闡述的那樣，如果你看一下我們第四季度的營運費用表現，基本上，我們通常——正如你所知，我們通常每年第四季度的費用水平最高。而我們在 2017 年第四季產生的額外支出，基本上都是一次性支出，我們預期不會經常發生。正如我所說，這與颶風造成的損失有關，這些損失非同尋常，而且是一次性的。此外，去年美國的稅率為 35%，而今年則為 21%。我們考慮了在何時進行此類可自由支配的支出，並將它們安排在可以從稅收方面獲益的時期。綜上所述，展望 2018 年，正如我所說，我們的指導意見表明，我們預計今年的營運率將再次達到 52% 至 54%。我認為，如果你觀察過去幾年的平均情況，你會發現，每季的利潤率和支出模式將與你所看到的非常一致。

Our next question comes from Matthew Harrison from Morgan Stanley.

下一個問題來自摩根士丹利的馬修·哈里森。

David, I was hoping you could just help us break out some items for 2018 guidance, particularly since you've got a couple moving pieces in terms of the bottom line here. If you could help us think about the impact that the tax rate had, the impact of the buyback versus the underlying performance of the business.

大衛，我希望你能幫我們分析 2018 年的績效指引，特別是考慮到這其中有幾個因素會影響最終結果。如果您能幫助我們思考稅率的影響、股票回購對公司基本績效的影響，那就太好了。

Yes. So I guess, what I would say is that, well, first of all, I think, the tax calculation is pretty straightforward in terms of take the 14% to 15% range and apply it to what would be pretax profit. I think, I gave you a range in terms of both operating margin and what we expect the below the line interest expense and income to be. So I think that, hopefully, will get you to a pretax income that you can apply the tax rate against. And then, in terms of the repurchase activity, we now have authorization in total of a little more than $14 billion for repurchases. And as I said, we could see that deployed as soon as the completion in the first half. Our guidance, of course, takes into consideration that there's some range of timing possibilities that our guidance covers in terms of the repurchase effect. So again, I think, you can apply some math to get to the share count and how that would impact your EPS. And it's included in the guidance.

是的。所以我想說的是，首先，我認為稅收計算相當簡單，只需將 14% 到 15% 的稅率範圍應用於稅前利潤。我認為，我已經給出了營業利潤率以及我們預期的線下利息支出和收入的範圍。所以，我希望這樣能讓你得到稅前收入，然後就可以再按稅率繳稅了。此外，就回購活動而言，我們現在總共獲得了略高於 140 億美元的回購授權。正如我所說，我們可以在上半場結束後立即看到它的部署。當然，我們的指導意見考慮到了回購效應方面存在一定的時機可能性範圍。所以，我認為，你可以運用一些數學方法來計算股份數量以及這會對你的每股盈餘產生怎樣的影響。而且，這部分內容也包含在指導方針中。

Our next question comes from Terence Flynn from Goldman Sachs.

下一個問題來自高盛的特倫斯·弗林。

Maybe just a follow-up to Jeff's earlier question. Bob, during your prepared remarks, you mentioned you're well-positioned to capitalize on consolidation opportunities for your shareholders, just wondering if you'd consider larger scale mergers? Or is that primarily bolt-ons, similar to your prior history as Onyx as a recent example?

或許這是對 Jeff 先前問題的後續問題。鮑勃，你在事先準備好的發言中提到，你們公司處於有利地位，能夠為股東抓住整合機會。我想知道你們是否會考慮更大規模的併購？或者說，這主要是外加一些配件，類似於你之前作為 Onyx 的經歷，例如最近的一個例子？

Well, I said 2 things, Terence. I said we're well-positioned to address ongoing changes in the health care environment and we expect there will continue to be ongoing pressure from the health care environment and that we were also well-positioned to capitalize on consolidation for the benefit of our shareholders. So we've been consistent for some time in saying that we have the financial capacity and we're interested in looking for deals that we think we can add value to in our areas of focus, so we're going to continue to do that. And as the other question implied, we have felt for some time that there are pockets of excess capacity in the industry and we'll look to see whether we can help create some value by being part of the consolidation around those.

特倫斯，我說了兩件事。我說過，我們已做好充分準備應對醫療保健環境的持續變化，我們預計醫療保健環境將繼續帶來持續的壓力，我們也已做好充分準備利用整合來造福我們的股東。因此，我們一直以來都堅持認為，我們有足夠的財力，我們有興趣尋找我們認為可以在我們關注的領域內創造價值的交易，所以我們將繼續這樣做。正如另一個問題所暗示的那樣，我們一直覺得業內存在一些產能過剩的領域，我們將看看我們是否能夠透過參與這些領域的整合來幫助創造一些價值。

Our next question comes from Michael Yee from Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

When I think about your 2018 guidance, I'm sure that people are trying to dig through the details of that, but I'm certainly trying to think that there's more uncertainties about beyond 2018. Back in 2014, you gave a long-term strategic outlook and you delivered on that, but I think people are kind of worried about beyond 2018. What are the factors that you need to get through, Bob or Dave, to think about longer-term guidance? Or maybe there is no need for longer-term guidance. What are you thinking about?

當我想到你們 2018 年的指導意見時，我相信大家都在努力挖掘其中的細節，但我當然認為 2018 年以後還有更多不確定因素。早在 2014 年，您就提出了長期策略展望，並且實現了這一目標，但我認為人們對 2018 年以後的情況有些擔憂。Bob 或 Dave，你們需要考慮哪些因素才能考慮長期指導？或許根本不需要長期指導。你在想什麼？

We'll both take a shot at your question, Mike. I think, you're right, we felt there was a big disconnect in 2014, and we were confident about the long-term outlook and we seem to be at a different place from our shareholders, so we found it helpful to try and address that disconnect with longer-term guidance. And as we said, I think, each of us said, we're confident about the long-term outlook for our business now and are excited about what we see is the long-term growth potential of the company. But we continue to talk to our shareholders and take their counsel about the benefit of thinking about the guidance question.

麥克，我們倆都來試著回答你的問題。我認為你說得對，我們感覺 2014 年存在很大的脫節，我們對長期前景充滿信心，但我們似乎與股東的看法不同，因此我們發現透過提供更長期的指導來解決這種脫節很有幫助。正如我們所說，我想我們每個人都說過，我們現在對公司的長期前景充滿信心，並對我們所看到的公司的長期成長潛力感到興奮。但我們會繼續與股東溝通，並聽取他們的意見，探討考慮績效指引問題的好處。

Our next question comes from Ronny Gal from Bernstein.

我們的下一個問題來自伯恩斯坦公司的羅尼·加爾。

Just a quick clarification for Tony and then a question for Sean. Tony, you mentioned that you're not seeing impact from the copay accelerator. My understanding of that, you will not expect to see one until late in the second quarter when patient begin to hit the maximum out-of-pocket costs. Am I -- do I have this wrong? Or is this something that we should see earlier in the year? And then, for Sean, on the BCMA program, obviously, you guys are putting some resources against it, how good does bispecifics have to be if we take them forward in comparison to what we're already seeing from the CAR T program, 50% or 70%? Or maybe just give us the parameters you're looking for to see if the product are good enough.

我先簡單澄清一下托尼的問題，然後問肖恩一個問題。東尼，你提到你沒有看到共付加速計畫的效果。據我了解，您預計要到第二季末，當患者的自付費用達到上限時，才會看到這種情況發生。我……我理解錯了嗎？或者，我們應該在今年早些時候就看到這種情況？然後，對於肖恩來說，關於BCMA項目，顯然你們投入了一些資源，如果我們要推進雙特異性抗體療法，與我們已經從CAR-T療法中看到的療效相比，雙特異性抗體療法需要達到什麼程度才行，50%還是70%？或者，您也可以告訴我們您想要的參數，以便我們判斷該產品是否夠好。

So Ronny, to answer your first part of your question, this is Tony, the accumulated programs would, of course, depend on what the individual patient's deductible is. But as I said, we are seeing and predicting minimal impact in the first quarter. And by definition, I would therefore see minimal impact in the second as well by Amgen.

所以羅尼，回答你問題的第一部分，我是東尼，累積的療程當然取決於每個病人的自付額是多少。但正如我所說，我們預計第一季受到的影響將微乎其微。因此，根據定義，我認為安進對第二方面的影響也微乎其微。

Yes, with respect to our BCMA BiTE programs, I think that our view is that it's going to be important for us to be able to demonstrate data. And these comparisons can be very complex. The patient populations and the pretreatment of patients and things of this sort in the CAR T studies is often very different than these calculations that we generate in our data set, so comparisons can be hard. But the bottom line is everyone that we talked to in this field believes that if you can take a product like a BiTE off the shelf, administer it and get a similar degree of efficacy with potentially less of the safety risk and the enormous costs that can be associated with those safety risks in the hospital, that BiTE would be preferred modality. As I've said many times, I think, there's a role for both these modalities in the spectrum of care for even an individual patient in oncology setting.

是的，就我們的 BCMA BiTE 專案而言，我認為我們的觀點是，能夠展示數據對我們來說非常重要。而且這些比較可能非常複雜。CAR T 研究中的患者群體、患者的預處理等情況通常與我們在資料集中產生的計算結果大相徑庭，因此比較起來可能很困難。但歸根結底，我們與該領域的每個人交談後都認為，如果能從貨架上買到像 BiTE 這樣的產品，使用後就能獲得類似的療效，同時安全風險可能更低，醫院裡與這些安全風險相關的成本也可能更低，那麼 BiTE 將是首選的治療方式。正如我多次說過的那樣，我認為，即使在腫瘤治療中，這兩種治療方式在護理的各個方面都有其作用，即使是對單一患者也是如此。

And our next question comes from Umer Raffat from Evercore ISI.

下一個問題來自 Evercore ISI 的 Umer Raffat。

I wanted to ask 3, if I may. One, on court decisions from PCSK9 antibody patents that we saw last year, do you think they have any read across to the upcoming Enbrel District Court litigation? Second, on Sensipar and the -- it seems like a big swing factor in your 2018 guidance. My question is this, there was an IPR on one of your 2026 patents, which was never instituted, so in that context, the question I have is, how is a generic entry possible? Or said another way, are you aware of a non-infringing formulation? And then, finally, just a quick one, how much CGRP in your 2018 guidance?

如果可以的話，我想問3個問題。第一，關於去年我們看到的 PCSK9 抗體專利的法院判決，您認為這些判決對即將到來的 Enbrel 地區法院訴訟有任何借鑒意義嗎？其次，關於 Sensipar 和——這似乎是你們 2018 年業績指引的一個重大影響因素。我的問題是這樣的，你們的一項 2026 年專利曾被提起 IPR 訴訟，但從未正式立案。在這種情況下，我的問題是，如何才能進行通用註冊？換句話說，您是否知道不存在不侵權的配方？最後，再問一個問題，你們 2018 年的績效指引中 CGRP 是多少？

Sorry, what was the third question, we're trying to track you there.

抱歉，第三個問題是什麼來著？我們正在努力找到您。

CGRP in the 2018 guidance.

2018 年指引中的 CGRP。

Okay. All right. Okay. Umer, obviously, we have ongoing litigation. I don't think it's appropriate to comment on your Sensipar question. And I wouldn't try to read across -- I wouldn't try to do the meta-analysis in intellectual property land across the 2 trials that you referenced. David, do you want to -- we're obviously not going to give individual product guidance, Umer, at this point. You know we're excited about the product, we're excited about being first. It's a symptomatic population. And the interest in having a new therapy that makes a big difference is high but we're not going to give you a product -- individual product launch guidance at this point.

好的。好的。好的。烏默，很顯然，我們還有未決的訴訟。我覺得不宜對你提出的Sensipar問題發表評論。我不會嘗試進行交叉解讀——我不會嘗試對你提到的這兩項試驗進行知識產權領域的薈萃分析。大衛，你想——顯然，烏默，在這一點上，我們不會提供具體的產品指導。你知道我們對這款產品感到非常興奮，我們對成為第一家感到興奮。這是有症狀人群。人們對能夠帶來重大改變的新療法抱有很高的興趣，但目前我們不會提供任何產品——個別產品的上市指導。

(Operator Instructions) And our next question does come from Geoffrey Meacham from Barclays.

（操作員說明）我們的下一個問題來自巴克萊銀行的傑弗裡·米查姆。

Bob, when you think about deals, how much of a priority is a return to top line growth versus just managing cash flow? And then, very related, have you guys ever explored a split or some sort of a segmentation of the business, just to separate the mature franchises from the earlier cycle products and pipeline?

鮑勃，當你考慮交易時，恢復營收成長的優先順序比管理現金流的優先順序高多少？另外，還有一個很相關的問題，你們有沒有考慮過拆分或對業務進行某種形式的細分，將成熟的特許經營權與早期週期產品和渠道分開？

Okay. Geoff, our focus when we look at deals is on -- we're looking to deploy capital that we think we can earn a return for our shareholders from. So it's very easy to find accretive deals. It's very hard to find deals that are both accretive and add to the long-term return on capital for our shareholders. So we're going to continue to be disciplined. We know the 6 areas that we're interested in. And with respect to your second question, again, I think, you know our track record in this regard. We've been very active and very focused on looking at always to create value for our shareholders. And we'll continue to do that.

好的。傑夫，我們在考察交易時關注的是──我們尋找的是能為股東帶來回報的資本。因此，找到增值交易非常容易。很難找到既能增加公司收益又能提高股東長期資本回報率的交易。所以我們會繼續保持自律。我們知道我們感興趣的六個領域。至於你的第二個問題，我想你也了解我們在這方面的過往紀錄。我們一直非常積極，並始終專注於為股東創造價值。我們將繼續這樣做。

And our next question comes from Eric Schmidt from Cowen and Company.

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

Just a question for Tony on Repatha. If I'm doing the math right on Slide 23, with the volume and sales gains that you had, it looks like there was a net 15% quarter-on-quarter decline in Repatha's price, is that true? And maybe you could provide some color on what's going on there.

我想問托尼一個關於瑞百安（Repatha）的問題。如果我按照幻燈片 23 中的計算方法正確，考慮到你們的銷量和銷售額增長，Repatha 的價格似乎環比淨下降了 15%，是這樣嗎？或許您可以詳細介紹一下那裡的情況。

Eric, I actually couldn't give you the details with that one right now. There was clearly a change in the net price but I don't think it was that high. We can come back to you guys and give you the details on that, but I don't have them with me.

艾瑞克，我現在還無法告訴你這件事的詳細情況。淨價顯然發生了變化，但我認為變化幅度並不大。我們可以稍後再向你們提供詳細信息，但我現在手頭上沒有這些信息。

Our next question comes from Alethia Young from Crédit Suisse.

下一個問題來自瑞士信貸的 Alethia Young。

One for Sean. What other additional Phase II programs would you consider for tezepelumab? Maybe anything in allergies or anything like that?

給肖恩的一份。您還會考慮哪些其他針對tezepelumab的II期臨床試驗項目？或許是過敏之類的問題？

Yes. Right now, I think, the things we're kind of excited about in Phase II are AMG 301 in migraine, which is we're in a strong leading position with that mechanism and hope to see that it will be either synergistic with CGRP or address patients that don't respond to CGRP inhibition. And we have also the IL-2 mutein program, AMG 592, I'd highlight as a program that is moving into multiple Phase II autoimmune disorders. And that's a mechanism, as you may know, where we're able to affect the population of T reg cells in a profound way with this engineered form of IL-2. The number of our BiTE programs are, while they are in Phase I, the next study for them could, in fact, like it was for BLINCYTO, be registration-enabling. So this Phase I, II, III line gets pretty blurred in the oncology area particularly. So I consider a lot of the molecules that are in the clinic, including our MCL-1 inhibitor, to be potentially in a preregistration study as the next study type of status.

是的。目前，我認為我們在 II 期臨床試驗中最令人興奮的是 AMG 301 在偏頭痛方面的應用，我們在該機制方面處於領先地位，並希望看到它能與 CGRP 產生協同作用，或者能夠治療對 CGRP 抑製劑無反應的患者。此外，我們還有IL-2突變體計畫AMG 592，我想重點介紹一下，該計畫正在進入多個II期自體免疫疾病的治療階段。正如您可能知道的那樣，我們可以透過這種經過改造的 IL-2 形式，以深刻的方式影響 T reg 細胞的數量。雖然我們的 BiTE 專案目前處於第一階段，但實際上，它們的下一個研究可能會像 BLINCYTO 一樣，最終實現註冊。因此，在腫瘤領域，I期、II期、III期之間的界線變得相當模糊。因此，我認為許多正在進行臨床研究的分子，包括我們的 MCL-1 抑制劑，都有可能進入預先註冊研究階段，這是下一個研究類型。

And our next question comes from Cory Kasimov from JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

Mine's on Repatha. And I recognize it's really recent but I'm interested in a little more color. On the early feedback you're getting from the field on the drug post the inclusion of CVOT in the label and really, more importantly, how much of a difference you expect the label to make given that you guys make it sound like it's still a payer access issue and payers have been aware of this data for a longer period of time?

我的手機在Repatha上。我知道這確實是最近才出現的，但我對色彩更豐富的一些作品更感興趣。在標籤中加入 CVOT 後，您從第一線人員那裡得到的早期回饋是什麼？更重要的是，考慮到你們的說法似乎仍然是支付方准入問題，而支付方已經了解這些數據很長時間了，你們預計標籤會帶來多大的變化？

So Tony, let me respond to that one. As I said a couple of times, since launch, we've been able to talk to physicians about the product being able to lower LDL. From a promotional perspective, which is probably 98% of our physicians who don't attend the large congresses, we have not been able to be in a position to talk about the real benefit of Repatha dramatically lowering LDL and thereby reducing the risk of heart attack and stroke. Just to give you an idea of how fast this has moved, we got the approval on the Friday at about 11:35 a.m. By Tuesday, we had trained our entire team of managers on actual promotional material. By the Thursday, we trained the entire sales force. By Saturday, we trained 250 cardiologist speakers. And by the next week, they had completed just over 200 speaker programs with an average of about 15 people attending each speaker program. I've never seen such rapid uptake of a speaker program from an -- these are promotional speaker programs where the cardiologists are talking specifically from the new label. The feedback from the sales force to date has been very positive. People now are truly understanding the value of what the drug does. And when I look at the last 2 weeks average NBRxs, they're about 18%, 20% higher than the average of the 4 weeks for December. So yes, it's tough to read this early on, but we are seeing an uptick in new patients getting through, getting approved. When I look at our payer or access environment, I see the commercial plans sort of January of 2017 are improving -- have improved by about 8% in terms of the approvals. Our Part D coverage has improved by about 30%. So we continue to work hard to make sure people understand the value of this drug. And I think more and more cardiologists and physicians are putting forward appropriate patients and fighting for them to get on the drug.

東尼，讓我來回答這個問題。正如我之前多次提到的，自從產品上市以來，我們已經能夠與醫生討論該產品降低低密度脂蛋白膽固醇（LDL）的能力。從推廣的角度來看，對於我們98%不參加大型會議的醫生來說，我們一直無法有機會談論Repatha的真正益處，即顯著降低LDL，從而降低心臟病發作和中風的風險。為了讓你們了解這件事進展有多快，我們在週五上午 11 點 35 分左右就獲得了批准。到週二，我們已經對整個管理團隊進行了實際宣傳材料的培訓。到週四，我們已經完成了全體銷售人員的培訓。到週六，我們已經培訓了 250 位心臟科醫生演講者。到下週，他們已經完成了 200 多場演講活動，平均每場演講活動約有 15 人參加。我從未見過如此迅速地接受演講者計劃——這些都是推廣演講者計劃，心臟病專家專門代表新品牌進行演講。到目前為止，銷售團隊的回饋非常積極。人們現在真正了解這種藥物的作用價值。當我查看過去兩週的平均 NBRx 時，發現它們比 12 月 4 週的平均值高出約 18% 到 20%。所以，是的，現在就得出這樣的結論很難，但我們看到獲得批准的新患者數量正在增加。當我審視我們的支付方或准入環境時，我發現商業計劃在 2017 年 1 月左右有所改善——就批准情況而言，已經改善了約 8%。我們的D部分保險覆蓋範圍提高了約30%。因此，我們繼續努力，確保人們了解這種藥物的價值。而且我認為越來越多的心臟科醫生和內科醫生正在推薦合適的患者，並爭取讓他們服用這種藥物。

And our next question comes from Salim Syed from Mizuho Securities.

下一個問題來自瑞穗證券的Salim Syed。

I just had one on Repatha. So Eugene Braunwald spoke recently at The Medicines Company Investor Day and spoke specifically regarding primary prevention with Inclisiran. I was curious what your thoughts were on that and if there's any impact to Repatha as it relates to that? And specifically, also, do you think Inclisiran can be inserted between a statin and Repatha?

我剛服用了一片瑞百安（Repatha）。所以，尤金·布勞恩瓦爾德最近在醫藥公司投資者日上發表了講話，並專門談到了使用 Inclisiran 進行一級預防。我很好奇您對此有何看法，以及這是否會對瑞百莎（Repatha）產生任何影響？另外，您認為Inclisiran可以插入他汀類藥物和Repatha之間嗎？

This is Sean. I'll try to respond. I think, obviously, the kinds of populations that can be addressed with these agents are identical, so the kind of populations that have been treated with statins over the years. We focused on a very high-risk secondary prevention type population, although our label in both the U.S. and Europe is broader than that. And I think that it's perfectly reasonable to study high-risk primary prevention patients. However, when you look at the situation we face right now where it's so difficult to get these drugs to patients who have experienced multiple events and have very high levels of LDL, I'm not sure that's the direction strategically that I would go if I were going to do another outcomes trial, but it's a reasonable thing to do. In terms of sequencing these therapies, that all depends on the effect size that can be achieved, the safety profile of a novel mechanism platform technology like siRNA in a very broad population. The bar is extremely high, obviously, from an efficacy safety perspective with Repatha.

這是肖恩。我會盡量回覆。我認為，很顯然，這些藥物可以治療的族群是相同的，也就是多年來一直用他汀類藥物治療的人。我們重點關注的是高風險二級預防族群，儘管我們在美國和歐洲的定義範圍比這更廣。我認為對高風險一級預防患者進行研究是完全合理的。然而，考慮到我們目前面臨的情況，即很難將這些藥物送到經歷過多次事件且低密度脂蛋白膽固醇水平非常高的患者手中，如果我要進行另一項結果試驗，我不確定這是否是我會採取的戰略方向，但這確實是一件合理的事情。就這些療法的順序而言，這完全取決於能夠達到的效果大小，以及像 siRNA 這樣的新型機制平台技術在非常廣泛的人群中的安全性。從療效和安全性的角度來看，Repatha 的標準顯然非常高。

And our next question comes from Ian Somaiya from BMO Capital Markets.

下一個問題來自 BMO 資本市場的 Ian Somaiya。

I had another one on Repatha. You previously commented on maybe a willingness to speak with payers or negotiate with payers on rebates and pricing once CVOT was on the label. I guess, we've gotten to that point. And then, separately, once the guidelines reflected the recommendations, I'm just curious where are we from a price rebate negotiation standpoint and how much room is there for us to see changes in sort of the pricing structure of PCSK9 going forward?

我還有一次服用的是瑞百阿。您之前曾表示，一旦 CVOT 被列入標籤，或許願意與付款方溝通或就回扣和定價進行談判。我想，我們已經到了那個地步了。然後，另外，一旦指南反映了這些建議，我很好奇從價格回扣談判的角度來看，我們現在處於什麼位置，以及我們未來在 PCSK9 的價格結構方面還有多少變化空間？

So it's Tony. So as we talked last year, we are in constant debate and discussion with payers and providers around the value of this drug, about the value-based pricing we have and the rebates that have been offered in the marketplace to ensure improved levels of access. So we continue to work with the payers on an ongoing basis to ensure we get a good position on the formulary, that we have improved on the utilization management criteria where, fundamentally, just about every plan has improved on that one quite dramatically. We have worked hard to ensure that we can assist patients where appropriate with copays, that they are not able to afford or deductibles they're unable to afford. And I don't think that we're just going stop for a while as we go forward.

原來是托尼。正如我們去年所討論的，我們一直在與支付方和醫療服務提供方就這種藥物的價值、我們基於價值的定價以及市場上提供的回扣進行辯論和討論，以確保提高藥物的可及性。因此，我們繼續與支付方持續合作，以確保我們在處方集方面取得良好地位，並且我們在利用管理標準方面有所改進，從根本上講，幾乎每個計劃在這方面都得到了相當大的改進。我們一直努力確保在適當情況下能夠幫助患者支付他們無法負擔的共同支付費用或自付額。而且我認為，我們不會就此停滯不前。

And our next question comes from Andrew Peters from Deutsche Bank Equity Research.

下一個問題來自德意志銀行股票研究部的安德魯彼得斯。

So I guess, maybe to switch gears a bit on a slightly different topic. On the next-gen manufacturing side, just wanted to see how and if this new technology could potentially impact margins? And then, more broadly, as you talk about kind of the Made by Amgen stamp for the biosimilar franchise, as you think about biosimilar production in general, how do you think Amgen is differentiated? And from a margin perspective, as you think about biosimilars, is that something that can fit into your pricing strategy on a competitive basis as well?

所以我想，或許我們應該稍微轉換一下話題，換個角度聊聊。在下一代製造方面，我只是想了解這項新技術是否會對利潤率產生潛在影響？然後，更廣泛地說，當您談到安進生物類似藥系列的「安進製造」標誌時，當您思考生物相似藥的生產時，您認為安進是如何脫穎而出的？從利潤率的角度來看，當您考慮生物相似藥時，它是否也能融入您的定價策略中，從而在競爭中發揮作用？

I'm going to take this in 2 parts, David, and I can respond to your question, Andrew. First, with respect to next-generation manufacturing, we've been talking about this, as you know, for some time. We're delighted or excited that global regulators have approved our first of these facilities in Singapore. And when we committed to that -- first began talking about some years ago, we were clear that both as a consequence of the lower capital cost and the meaningfully lower operating costs, we would expect, over time, a benefit to be reflected in our cost of sales line and that will happen. And generally, we have said and we still believe that manufacturing is a source of competitive advantage at Amgen. We have a track record of supplying every patient every time. And we think, when it comes in particular to biosimilars, the reliability, the safe supply and reliable supply of biosimilar medicines from Amgen will be a differentiator.

大衛，我會分成兩個部分來回答這個問題，安德魯，之後我再回答你的問題。首先，關於下一代製造技術，如您所知，我們已經討論這個問題一段時間了。我們非常高興，全球監管機構已經批准了我們在新加坡的首個此類設施。當我們做出承諾時——幾年前我們開始討論這個問題——我們就明確表示，由於資本成本降低和營運成本大幅降低，我們預計隨著時間的推移，銷售成本線將會受益，而這種情況也必將發生。總的來說，我們過去說過，現在仍然認為，製造業是安進的競爭優勢來源。我們一直以來都能保證每次都能為每位患者提供所需物資。我們認為，尤其是在生物相似藥方面，安進公司生物相似藥的可靠性、安全供應和穩定供應將是一個差異化因素。

Yes, I guess, I would add, when we set out on the journey to get to our current margin structure, we talked about a number of things that were contributing to us achieving that. And certainly, as Bob just talked about, the first module of this next-gen manufacturing is now going to be helping us and this next module will continue to enable us to drive our competitiveness. I would caution against thinking that you should think there's a big step up from where we're operating right now because, I think, we're operating in a very nice place in terms of our own competitiveness. And so think about driving continued cost down to enable us to then continue and increase our investments in particular in support of these new products that are going after very large patient populations. So we're thinking about continuously driving our cost base to allow us to invest heavily in support of growth for the business.

是的，我想補充一點，當我們開始建立目前的利潤結構時，我們討論了許多促成我們實現這一目標的因素。當然，正如鮑伯剛才所說，下一代製造技術的第一個模組現在正在幫助我們，而下一個模組將繼續幫助我們提升競爭力。我建議大家不要認為我們現在的經營狀況會有很大提升，因為我認為，就我們自身的競爭力而言，我們目前的經營狀況已經非常好了。因此，要考慮如何持續降低成本，以便我們能夠繼續並增加投資，特別是支持這些面向龐大患者群體的新產品。因此，我們正在考慮不斷降低成本，以便能夠大力投資，支持業務成長。

Our next question comes from Carter Gould from UBS Equities.

下一個問題來自瑞銀股票部的卡特古爾德。

For Sean, follow-up on the earlier question given all the excitement. Recently, we've seen agents focused on inflammation go relatively broad in terms of indications, yet you're proceeding relatively narrowly despite a central role in inflammation. Is that more because of the rest of your portfolio assets are risk mitigation product? Or should we expect the list of indications to expand?

對於肖恩來說，鑑於大家的熱情，請繼續回答先前的問題。最近，我們看到一些針對發炎的藥物在適應症方面發展得比較廣泛，然而，儘管發炎中起著核心作用，但你們的治療範圍卻相對狹窄。是因為你投資組合中的其他資產都是風險緩解產品？或者我們應該預期適應症清單會擴大？

Yes, it's a good question. I mean, what I would say is that we believe that there is a particularly profound level of unmet need in asthma and for an agent that could be given to sort of all comers without having to parse patients by fairly complex criteria that are difficult to assess in the average clinician's office. So I personally believe that, that is an area of particular opportunity for biologic therapy like tezepelumab. I think that COPD, it represents another very substantial opportunity. And because of the nature of this mechanism, one could believe that it might be more likely to have efficacy in a setting like that than some of the other therapies that are directed more at the inflammatory cascades that downstream in asthma. And there are other disease areas like atopic dermatitis that we continue to explore. And I'm sure, as with all of these products in the inflammation space, once a product has a kind of an anchored core profitable indication, virtually, every good idea and a variety of not so good ideas get explored by either companies or investigator-sponsored studies trying to find every possible nook and cranny where the product might work.

是的，這是個好問題。我的意思是，我們認為氣喘領域存在著非常嚴重的未滿足需求，需要一種可以用於幾乎所有患者的藥物，而無需根據相當複雜的標準來篩選患者，而這些標準在普通臨床醫生的辦公室裡很難評估。所以我個人認為，對於像tezepelumab這樣的生物療法來說，這是一個特別有發展機會的領域。我認為慢性阻塞性肺病（COPD）代表著另一個非常重要的機會。由於這種機制的性質，人們可能會認為，在這種情況下，它比一些針對氣喘下游發炎級聯的其他療法更有可能有效。我們也將繼續探索其他疾病領域，例如異位性皮膚炎。而且我確信，就像發炎領域的所有產品一樣，一旦某種產品有了某種固定的核心盈利適應症，幾乎所有好的想法和各種不太好的想法都會被公司或研究者贊助的研究探索，試圖找到該產品可能發揮作用的每一個角落。

And our last question for the call comes from Kennen MacKay from RBC Capital Markets.

本次電話會議的最後一個問題來自加拿大皇家銀行資本市場的 Kennen MacKay。

One for Bob and David here. David, you'd mentioned there was now the balance sheet strength to really sort of grow the business and really deploy some of that capital. And Bob, sort of building off what you'd mentioned surrounding a focus on transformative therapies Aimovig, like Prolia, like Repatha, I just wanted to get a perspective on what was out there that you really sort of view as interesting? We've seen a lot of consolidation in the CAR T space, do you have some exposure there owning a couple of the Kite, now Gilead program. Is there anything like in-gene therapy or gene editing? Or does that really not align with the positioning of sales and volumes converging in the years ahead?

這裡獻給鮑勃和大衛。大衛，你之前提到過，現在公司的資產負債表實力雄厚，可以真正發展業務並真正利用一些資本。鮑勃，基於你之前提到的關於變革性療法（如 Aimovig、Prolia、Repatha）的關注，我想了解一下你認為目前有哪些療法比較有趣？我們看到 CAR-T 領域出現了大量的整合，您是否在該領域有所涉足，例如持有 Kite（現為 Gilead）的幾家公司？是否存在類似基因療法或基因編輯的技術？或者說，這真的與未來幾年銷售額和銷售趨於一致的定位不符嗎？

Yes, I guess, this is Meline. What I would comment on in terms of the opportunities out there, we've been, I think, pretty clear that we're been focused in particular on the 6 areas where we've decided to establish a commercial presence, and so we tend to orient ourselves towards those opportunities. And we're quite clear in the market that we want to see everything of any size that might be of interest to us across those areas. And that, Ken -- and maybe Sean would want to comment on technology, but certainly...

是的，我想，這就是梅琳。就目前的機會而言，我認為我們已經非常明確地表示，我們特別關注我們決定建立商業存在的六個領域，因此我們傾向於將自己定位在這些機會上。我們在市場上的態度非常明確，我們希望看到各個領域中所有可能引起我們興趣的任何規模的項目。肯，還有，肖恩或許也想對科技方面發表一些看法，但當然…

I would just -- since you mention some of these emerging technology platforms like gene editing for therapeutic purposes or gene therapy, that the earlier these kind of things are, the more likely it is that we will look at them even if they aren't in 1 of the 6 areas, because if we thought there's a breakthrough opportunity emerging and we could bring to bear our scientific and manufacturing commercial capabilities and so on, we have shown that we'll move on those kind of things.

我想說的是——既然你提到了基因編輯用於治療目的或基因療法等新興技術平台，那麼這類技術出現得越早，我們就越有可能關注它們，即使它們不屬於這六個領域之一，因為如果我們認為出現了突破性的機會，並且我們可以運用我們的科學、製造和商業能力等等，我們已經表明我們會推進這類事情。

All right. Well, I think, Ken and Sean and David did a good job answering that question, so rather than add to it, let me just, again, thank you all for your forbearance on the call that went a little longer than usual from us. But just to wrap up, we're heading into 2018, as I think you can tell from our remarks, we're excited. We think we're operating the business well. We have strong products. We have an attractive pipeline that's advancing rapidly. And strategically, we think we're well-positioned and focused on delivering growth and value for our shareholders. So we look forward to reconvening with all of you in April and see how we do for the first quarter. Thank you.

好的。嗯，我覺得 Ken、Sean 和 David 已經很好地回答了這個問題，所以我就不再贅述了，再次感謝大家對我們這次通話的耐心，這次通話比平時要長一些。最後總結一下，我們即將邁入 2018 年，我想你們從我們的演講中也能看出，我們對此感到非常興奮。我們認為我們的業務運作狀況良好。我們擁有強大的產品實力。我們擁有極具吸引力且進展迅速的產品線。從策略角度來看，我們認為我們已做好充分準備，專注於為股東創造成長和價值。因此，我們期待在四月與大家再次相聚，看看第一季的業績如何。謝謝。

And I would just like to add my gratitude for your patience. Had a lot of topics to cover today, of course, between myself and my team, we'll be standing by for several hours so if you have any questions feel free to call us. Thanks again.

我還要感謝您的耐心等待。今天有很多話題要討論，當然，我和我的團隊會待命幾個小時，所以如果您有任何問題，請隨時致電我們。再次感謝。

This does conclude today's call. You may now disconnect. Thank you for your participation.

今天的電話會議到此結束。您現在可以斷開連線了。感謝您的參與。