美國安進 (AMGN) 2018 Q2 法說會逐字稿

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

我叫伊恩，今天我將擔任安進公司 2018 年第二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. You may now begin.

現在我謹向大家介紹投資人關係副總裁 Arvind Sood。現在你可以開始了。

Thanks, Ian. Good afternoon, everybody. Thanks for taking the time to participate in our Second Quarter Results Conference Call today. We realize it's a very busy day with a number of companies reporting, but unfortunately, we are going to add to your already long day as we have a lot to discuss today. Our Chairman and CEO, Bob Bradway will open up the discussion today with an overview of our business, the environment we operate in and management succession. Our CFO, David Meline, will then review our financial results for the second quarter in some detail and provide updated guidance for 2018. Tony Hooper, who leads our global commercial operations, will give you an update on how our products are performing, particularly those that have been launched recently. And then our Head of R&D, Sean Harper, will provide a pipeline update.

謝謝你，伊恩。大家下午好。感謝您今天抽空參加我們的第二季業績電話會議。我們知道今天很多公司都要發布財報，非常忙碌，但很遺憾，我們今天還要再給您增加一些工作量，因為我們有很多事情要討論。今天，我們的董事長兼執行長鮑勃·布拉德韋將首先概述我們的業務、我們所處的環境以及管理層繼任情況，以此拉開討論的序幕。我們的財務長大衛梅林隨後將詳細審查我們第二季的財務業績，並提供 2018 年的最新指引。負責我們全球商業營運的東尼胡珀將向大家介紹我們產品的表現情況，特別是最近推出的產品。然後，我們的研發主管肖恩哈珀將介紹研發管線的最新進展。

We will use slides to guide our discussion today and a link to these slides were sent separately. My customary reminder that we will use non-GAAP financial measures in today's presentation and some of the statements will be forward-looking statements. Our 10-K and subsequent filings identify factors that could cause our actual results to differ materially.

今天我們將使用幻燈片來引導討論，幻燈片的連結已單獨發送。我照例提醒大家，今天的演示中我們將使用非GAAP財務指標，其中一些陳述屬於前瞻性陳述。我們的 10-K 及後續文件列出了可能導致我們實際業績與預期有重大差異的因素。

So with that, I would like to turn the call over to Bob. But before I do, I would like to find a fun fact for the day. The crossword puzzle in the New York Times today, 30 down, the answer is Amgen. So with that, Bob, over to you.

那麼，接下來我將把電話交給鮑伯。但在此之前，我想先分享一個今天的趣聞。今天《紐約時報》的縱橫字謎，第 30 題的答案是安進公司 (Amgen)。那麼，鮑勃，接下來就交給你了。

Okay, thank you. And good afternoon, everyone, and welcome to the call. On today's call, I'll provide an overview of our second quarter performance, share some thoughts on the rapidly changing U.S. healthcare environment, and, of course, comment on the succession plans that we announced earlier today for 2 senior leaders you know very well, Sean Harper and Tony Hooper.

好的，謝謝。大家下午好，歡迎參加本次電話會議。在今天的電話會議上，我將概述我們第二季度的業績，分享一些關於美國醫療保健環境快速變化的看法，當然，還會評論我們今天早些時候宣布的兩位你們非常熟悉的資深領導人肖恩·哈珀和托尼·胡珀的繼任計劃。

First, our performance. Our second quarter results demonstrate that we continue to execute effectively our long-term growth strategy as we delivered 4% top line growth and 17% growth in non-GAAP earnings per share. An important part of our strategy is to increasingly focus on volume-driven growth and our results reflect the progress that we're making on that objective. Unit volumes increased, in many cases, by double digits, for all our newer products including Repatha, KYPROLIS, Prolia and XGEVA. We also continue to generate strong volume-driven growth outside the U.S. where our legacy brands have faced competition now for many years. This includes 9% growth in the second quarter.

首先，說說我們的表現。我們第二季的業績表明，我們繼續有效地執行長期成長策略，實現了 4% 的營收成長和非 GAAP 每股收益成長 17%。我們策略的重要組成部分是越來越注重銷售驅動成長，而我們的業績也反映了我們在該目標上取得的進展。包括 Repatha、KYPROLIS、Prolia 和 XGEVA 在內的所有新產品的銷售在許多情況下都實現了兩位數的成長。在美國以外的地區，我們的傳統品牌多年來一直面臨競爭，而我們也持續保持著強勁的銷售成長。這其中包括第二季9%的成長。

We remain confident that our newer product launches, as well as the medicines advancing through our pipeline, will enable us to drive attractive volume-driven growth globally over the long-term.

我們仍然相信，我們新推出的產品以及正在研發中的藥物，將使我們能夠在全球範圍內實現長期的、以銷量為導向的可觀增長。

Let me give you a few examples of some of the newer medicines that we are seeing driving our growth. In the second quarter, we launched Aimovig in the U.S., where it is the first and only CGRP inhibitor approved for migraine prevention. Aimovig also marks Amgen's first entry into a new therapeutic area for us, which is neuroscience. We've been very encouraged by the enthusiastic reception for Aimovig from physicians and especially from migraine patients, who've waited a long time for a new treatment option like this.

讓我舉幾個例子來說明一些推動我們業務成長的新藥。第二季度，我們在美國推出了 Aimovig，它是美國第一個也是唯一一個獲準用於預防偏頭痛的 CGRP 抑制劑。Aimovig 也標誌著安進首次進軍新的治療領域，即神經科學領域。醫生們，尤其是偏頭痛患者，對 Aimovig 的熱情反響令我們倍感鼓舞，他們已經等待這種新的治療方案很久了。

We are also encouraged by the progress we are making with Repatha, which we believe can play an important role in the fight against cardiovascular disease, the world's #1 killer. As you know, Repatha significantly lowers LDL cholesterol, which is a leading modifiable risk factor for cardiovascular disease. We have and will continue to work to expand access to Repatha globally.

我們對 Repatha 的進展也感到鼓舞，我們相信 Repatha 可以在對抗心血管疾病（世界頭號殺手）的鬥爭中發揮重要作用。如您所知，Repatha 能顯著降低低密度脂蛋白膽固醇，而低密度脂蛋白膽固醇是心血管疾病的主要改變危險因子。我們過去一直致力於擴大Repatha在全球的普及範圍，並將繼續努力。

Building on our decades of leadership in nephrology, we are seeing strong early adoption of Parsabiv, which is the first new treatment in more than a decade for secondary hyperparathyroidism in patients on hemodialysis.

憑藉我們在腎臟病學領域數十年的領先地位，我們看到 Parsabiv 得到了強有力的早期推廣，這是十多年來首個用於治療血液透析患者繼發性甲狀旁腺功能亢進症的新療法。

And now I'll say I'm pleased to report that we recently launched our first biosimilar, KANJINTI, which is a biosimilar to Herceptin in Europe. We put a strategic stake in the ground a few years ago to build a world-class biosimilars business, and we continue to believe that biosimilars represent a meaningful growth opportunity for us. We look forward to launching AMGEVITA, which is our biosimilar to HUMIRA, internationally later this year and to launching a steady stream of biosimilars in the years to come. My comments on biosimilars provide a good transition to a discussion of the healthcare environment in the U.S. If you'll note, just this past week, the FDA published its Biosimilars Action Plan. We're encouraged by the FDA's actions as well as by others in the Trump administration and we welcome the opportunity for open dialogue.

現在我很高興地宣布，我們最近推出了首款生物相似藥 KANJINTI，它是歐洲赫賽汀的生物類似藥。幾年前，我們制定了策略計劃，致力於打造世界一流的生物相似藥業務，我們仍然相信生物相似藥對我們來說是一個重要的成長機會。我們期待在今年稍後在國際上推出 AMGEVITA（我們的 HUMIRA 生物相似藥），並在未來幾年內持續推出一系列生物相似藥。我對生物相似藥的評論可以很好地引出對美國醫療保健環境的討論。請注意，就在上週，FDA 發布了其生物相似藥行動計畫。我們對FDA以及川普政府其他部門的行動感到鼓舞，並歡迎有機會進行公開對話。

Although we believe biosimilars can help address the issue of rising healthcare costs in general and concerns over drug pricing in particular, we also recognize that biosimilars alone aren't enough. Fundamentally, we believe that innovation is the key to alleviating the massive financial burden placed on society by chronic diseases like cancer, neurologic disorders and cardiovascular disease. And without innovation and improved access to it, the burden of chronic disease, which already runs in the hundreds of billions of dollars annually for any single one of these diseases will only grow larger as the population ages. And we'll continue to work with our colleagues in the industry to engage with the Administration, Congress and the entire health care community to find ways to promote innovation while also ensuring that our medicines are accessible and affordable for the patients who need them. We appreciate the Administration's engagement on this important issue. And as to prices, we made decisions a few months ago not to increase the prices of any of our medicines at mid-year, and we have no plans to change that for the balance of the year.

雖然我們相信生物相似藥可以幫助解決醫療保健成本普遍上漲的問題，特別是藥品定價問題，但我們也意​​識到，單靠生物相似藥是不夠的。從根本上講，我們認為創新是減輕癌症、神經系統疾病和心血管疾病等慢性疾病對社會帶來的巨大經濟負擔的關鍵。如果沒有創新和改善取得途徑，慢性病的負擔（僅一種慢性病每年就已造成數千億美元的損失）只會隨著人口老化而加重。我們將繼續與業內同仁合作，與政府、國會和整個醫療保健界進行溝通，尋找促進創新的方法，同時確保有需要的患者能夠獲得價格合理且負擔得起的藥品。我們讚賞政府對此重要議題的關注。至於價格方面，我們幾個月前就決定年中不提高任何藥品的價格，而且我們今年餘下的時間裡也沒有改變這一決定的計劃。

My final order of business before I turn the call over to David Meline is to discuss the executive succession announcements that we issued today. One of the hallmarks of a well-run company is a carefully considered succession planning process. And I believe that Amgen has done this well through our nearly 40-year history, and I'm confident we'll do so again as Sean Harper and Tony Hooper step down from their roles in anticipation of their forthcoming retirements.

在將電話交給大衛梅林之前，我最後要討論的是今天發布的關於高階主管繼任的公告。管理良好的公司的標誌之一是精心製定的繼任計劃流程。我相信，安進在近 40 年的歷史中一直做得很好，我相信，隨著肖恩哈珀和托尼胡珀即將退休並卸任，我們也會再次做到這一點。

I can't express strongly enough my deep appreciation for the contributions these 2 leaders have made to Amgen. They have played a critical role in transforming Amgen into the company we are today and their legacies will continue in the teams they've built and the patients that we'll serve. And above all, Sean and Tony have maintained a relentless focus on Amgen's mission to serve patients and we're a better company for it. As you all know, I have great respect and admiration for Sean and Tony, and they've been great partners and colleagues. And while they leave big shoes to fill, I'm excited about the 2 leaders who are succeeding them and I know Sean and Tony are committed to working with me and my team to ensure that our new leaders successfully transition into their roles.

我無法用言語表達我對這兩位領導人為安進公司所做貢獻的深深感激之情。他們在將安進發展成為今天的公司過程中發揮了至關重要的作用，他們的貢獻將透過他們建立的團隊和我們將服務的患者得以延續。最重要的是，肖恩和東尼始終堅持安進服務患者的使命，這使我們成為一家更好的公司。大家都知道，我非常尊重和欽佩肖恩和東尼，他們一直是很棒的合作夥伴和同事。雖然他們留下的空缺難以填補，但我對接替他們的兩位領導者感到興奮，我知道肖恩和托尼致力於與我和我的團隊合作，以確保我們的新領導者順利過渡到他們的崗位。

Let me start with Dave Reese, who is known to many of you and is someone I've worked closely with over the past decade. Dave has been with Amgen since 2005 and he's been closely involved with virtually all the medicines that have emerged from our pipeline since then. An oncologist by training, Dave has led discovery and research and parts of clinical development and he's also played a critical role in building our early-stage oncology pipeline, particularly our portfolio of BiTE molecules, which we find especially promising.

首先讓我介紹一下戴夫·里斯，你們中的許多人都認識他，在過去的十年裡，我一直與他密切合作。Dave 自 2005 年加入安進公司以來，幾乎參與了我們研發管線中所有新藥的研發工作。戴夫是一位受過專業訓練的腫瘤學家，他領導了發現和研究以及部分臨床開發工作，並且在構建我們的早期腫瘤產品線方面發揮了關鍵作用，特別是我們的 BiTE 分子產品組合，我們認為這些分子特別有前途。

His background includes past faculty appointments at UCLA and UCSF, and we're excited to have him assuming the new responsibilities here at Amgen today. Dave has joined us on the call and he'll have an opportunity to say a few words a little later this afternoon. Meanwhile, Tony's successor, Murdo Gordon, will be joining us in September from Bristol-Myers Squibb, where he most recently served as Chief Commercial Officer. His experience and capabilities are a perfect fit for where we are going strategically. Murdo has global experience at a time when we're looking to continue to expand our geographic presence. He's operated in a number of our core therapeutic areas of focus including cardiovascular disease, neuroscience, inflammation and oncology. And in addition, during his time at Bristol, Murdo led commercial operations in the U.S., which, as you know, is our largest market, and also had responsibility for value and access, which as I discussed earlier is an increasingly important component of today's dynamic health care environment. Tony will be in his role through much of the third quarter. He'll join us in welcoming Murdo on this earnings call in October. I'm looking forward to having Murdo and Dave become part of our leadership team. Both are exceptional, highly accomplished leaders well-suited for the opportunities ahead.

他曾任加州大學洛杉磯分校和加州大學舊金山分校的教職，我們很高興他今天能在這裡承擔安進公司的新職責。戴夫已經加入我們的電話會議，他今天下午晚些時候會有機會說幾句話。與此同時，東尼的繼任者默多·戈登將於 9 月從百時美施貴寶公司加入我們，他最近擔任該公司的首席商務官。他的經驗和能力與我們的策略發展方向完美契合。Murdo擁有豐富的全球經驗，而我們目前正尋求繼續擴大我們的地域覆蓋範圍。他曾在我們多個核心治療領域開展工作，包括心血管疾病、神經科學、發炎和腫瘤學。此外，在布里斯托爾任職期間，默多領導了美國的商業運營，正如您所知，美國是我們最大的市場，他還負責價值和准入，正如我之前討論過的，這在當今動態的醫療保健環境中是一個越來越重要的組成部分。托尼將在第三節的大部分時間裡擔任他的角色。他將和我們一起在10月的財報電話會議上歡迎默多的到來。我期待 Murdo 和 Dave 加入我們的領導團隊。他們都是傑出的、成就卓越的領導者，完全能夠勝任未來的機會。

With that, let me turn to David Meline for financial highlights.

接下來，我將邀請大衛梅林為大家帶來一些財經方面的重要訊息。

Okay, thanks, Bob. Overall, we are pleased with our strong performance in the second quarter as investments in support of our newer products delivered growth and our business continued to generate strong cash flow.

好的，謝謝你，鮑伯。總體而言，我們對第二季的強勁業績感到滿意，因為對新產品的投資帶來了成長，而且我們的業務繼續產生強勁的現金流。

Turning to the financial results on Page 6 of the slide deck. Worldwide revenues at $6.1 billion in the second quarter grew 4% year-over-year. Worldwide product sales at $5.7 billion in the second quarter grew 2% year-over-year, and strong unit demand from our newer products outpaced declines in our mature brands. We're also encouraged by the sustained double-digit volume growth from our ex-U. S. markets.

接下來請看投影片第6頁的財務表現。第二季全球營收達 61 億美元，年增 4%。第二季全球產品銷售額達 57 億美元，年增 2%，新產品的強勁需求超過了成熟品牌的下滑。我們也對除美國以外的地區持續兩位數的銷售成長感到鼓舞。美國市場。

Other revenues at $380 million increased $144 million year-over-year due to a milestone payment received related to our Aimovig partnership with Novartis. Non-GAAP operating income at $3.1 billion grew 2% from prior year. Non-GAAP operating margin at 55.1% for the quarter. As in prior years, our operating margin is expected to be lower in the remaining quarters of the year, driven by the timing of expenses. As mentioned last quarter, we continue to evaluate incremental investments in our products and pipeline as well as external opportunities to drive growth and maximize shareholder value. On a non-GAAP basis, cost of sales as a percent of product sales increased by 0.4 points to 13.1%, driven by higher manufacturing cost and unfavorable product mix, partially offset by lower royalty revenue -- expense, sorry. Research and development expenses at $850 million or 15% of product sales were relatively unchanged in the second quarter of 2018 versus last year. For the full year, we expect research and development expense as a percent of product sales to be comparable to 2017 levels.

其他收入為 3.8 億美元，年增 1.44 億美元，因為收到了與我們和諾華公司 Aimovig 合作相關的里程碑付款。非GAAP營業收入為31億美元，較上年成長2%。本季非GAAP營業利益率為55.1%。與往年一樣，受費用發生時間的影響，預計今年剩餘幾季的營業利潤率將有所下降。正如上個季度所提到的，我們將繼續評估對產品和研發管線的增量投資，以及外部機會，以推動成長並最大限度地提高股東價值。以非GAAP準則計算，銷售成本佔產品銷售額的百分比上升了0.4個百分點，達到13.1%，主要原因是製造成本上升和產品組合不利，部分被較低的特許權使用費收入（抱歉，是費用）所抵消。2018 年第二季研發費用為 8.5 億美元，佔產品銷售額的 15%，與去年同期相比基本維持不變。我們預計全年研發費用佔產品銷售額的百分比將與 2017 年的水準相當。

SG&A expenses increased 14% on a year-over-year basis, primarily driven by investments in product launches and marketed product support. We expect Q3 and Q4 spend levels to be consistent with Q2 as we continue to invest in our launch and growth products.

銷售、一般及行政費用年增 14%，主要原因是產品發布和市場推廣支援的投資。我們預計第三季和第四季的支出水準將與第二季保持一致，因為我們將繼續投資於我們的上市和成長產品。

In aggregate, non-GAAP operating expenses increased 7% year-over-year. Other income and expenses were a net $185 million expense in Q2. This is unfavorable by $29 million on a year-over-year basis. The non-GAAP tax rate was 14.2% for the quarter, a 3.2 point decrease versus the second quarter of 2017, due to the impacts of U.S. corporate tax reform offset partially by a prior year benefit associated with the effective settlement of certain state and federal tax matters. Non-GAAP net income increased 5% and non-GAAP earnings per share increased 17% year-over-year for the second quarter to $3.83 a share.

整體而言，非GAAP營運費用年增7%。第二季其他收入和支出淨額為 1.85 億美元。與上年同期相比，這不利了 2,900 萬美元。本季非GAAP稅率為14.2%，比2017年第二季下降3.2個百分點，這是由於美國企業稅制改革的影響，但部分被上一年因有效解決某些州和聯邦稅務事項而獲得的收益所抵消。第二季非GAAP淨利年增5%，非GAAP每股盈餘較去年同期成長17%，達到每股3.83美元。

Turning next to cash flow and the balance sheet on Page 7. The company generated $1.9 billion of free cash flow in the second quarter of 2018 versus $2.1 billion in the second quarter of 2017, driven by higher cash taxes resulting from the first installment of the repatriation tax paid in Q2 of 2018, partially offset by lower ongoing income tax liability as well as higher net income. We continue to provide significant cash returns to shareholders consistent with our commitment to deploy excess cash over time. In Q2, we deployed $3.2 billion to repurchase 18.2 million shares at an average of $175 per share. Further, we plan to deploy an incremental $3 billion to $5 billion for share repurchase in the second half 2018. Lastly, our second quarter dividend increased to $1.32 per share, an increase of 15% over last year. Cash and investments totaled $29.4 billion, a decrease of $10 billion from the second quarter last year. This decrease over the last 12 months was primarily driven by $19 billion of cash returned to shareholders in the form of dividends and share buybacks, partially offset by over $10 billion of free cash flow generated in the same period. Our debt balance stands at $34.5 billion as of June 30, returning a weighted average interest rate of 3.9% and an average maturity of 11.7 years.

接下來，我們來看第 7 頁的現金流量和資產負債表。該公司在 2018 年第二季度產生了 19 億美元的自由現金流，而 2017 年第二季度為 21 億美元，這主要是由於 2018 年第二季度支付的第一筆匯回稅款導致現金稅收增加，但部分被較低的持續所得稅負債以及較高的淨收入所抵消。我們將繼續為股東提供豐厚的現金回報，這與我們承諾隨著時間的推移配置剩餘現金的承諾相一致。第二季度，我們投入 32 億美元回購了 1,820 萬股股票，平均每股價格為 175 美元。此外，我們計劃在 2018 年下半年追加 30 億至 50 億美元用於股票回購。最後，我們第二季的股息增加到每股 1.32 美元，比去年增長了 15%。現金及投資總額為294億美元，比去年第二季減少了100億美元。過去 12 個月的下降主要是由於以股息和股票回購形式向股東返還了 190 億美元的現金，部分被同期產生的超過 100 億美元的自由現金流所抵消。截至 6 月 30 日，我們的債務餘額為 345 億美元，加權平均利率為 3.9%，平均到期期限為 11.7 年。

Turning to the outlook for the business for 2018 on Page 8. We remain on track with our plans to continue investing in our pipeline, building out our global presence and increasing spend in support of long-term volume growth across large patient populations while delivering solid business performance. Today, we are revising our 2018 guidance, which reflects our strong Q2 performance and outlook for the second half of the year.

請參閱第 8 頁，以了解 2018 年的業務展望。我們將繼續按計劃投資於我們的產品線，擴大我們的全球業務，並增加支出以支持在龐大的患者群體中實現長期銷售增長，同時取得穩健的業務表現。今天，我們修訂了 2018 年的業績預期，這反映了我們第二季強勁的業績表現以及對下半年的展望。

Our latest revenue guidance is $22.5 billion to $23.2 billion versus prior guidance of $21.9 billion to $22.8 billion. This guidance reflects our solid performance to date as well as our confidence of continued good performance, while recognizing uncertainties related to potential new competition for Neulasta and Aranesp, and a range of potential Sensipar generic competition outcomes.

我們最新的營收預期為 225 億美元至 232 億美元，而先前的預期為 219 億美元至 228 億美元。這項指導意見反映了我們迄今為止的穩健表現以及我們對繼續保持良好表現的信心，同時也認識到與 Neulasta 和 Aranesp 可能出現的新競爭以及 Sensipar 仿製藥競爭可能帶來的各種不確定性。

With regard to our non-GAAP earnings per share guidance, we are revising the outlook to $13.30 to $14 per share versus previous guidance of $12.80 to $13.70 per share. We are reaffirming our prior non-GAAP tax rate guidance of 13.5% to 14.5%. We continue to expect capital expenditures of approximately $750 million this year. In this regard, we are breaking ground on our new manufacturing facility in Rhode Island in the next week.

關於我們的非GAAP每股盈餘預期，我們將預期從先前的每股12.80美元至13.70美元調整為每股13.30美元至14美元。我們重申先前的非GAAP稅率預期為13.5%至14.5%。我們預計今年的資本支出仍約為 7.5 億美元。為此，我們將在下週在羅德島為新的製造工廠舉行奠基儀式。

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

財務更新到此結束。我現在把電話轉給托尼。

Thank you very much, David, and good afternoon, folks. You'll find our product sales starting on Slide #10. I'm also pleased to report we delivered a solid second quarter with 2% year-over-year product sales growth. Let me first add to Bob and Dave's comments regarding our focus on volume-driven growth. We recognized early on that the evolving U.S. landscape should lead us to focus on investments in brands that serve large patient populations in addition to our traditional focus on more targeted specialized therapies. We also made the strategic decision to advance and bring to market a broad biosimilar portfolio. We're making good progress on all these fronts. As evidence, you can see our strong growth in Prolia and Repatha, and our early success with Aimovig, 3 medicines that treat diseases affecting tens of millions around the world. We are also now in the market with our first biosimilar with several more to follow. In addition, our continued volume growth outside the U.S. serves as a model for what growth in the U.S. can look like in the future.

非常感謝你，大衛，各位下午好。我們的產品銷售資訊從第 10 張投影片開始。我很高興地報告，我們第二季業績穩健，產品銷售額年增 2%。首先，我想補充 Bob 和 Dave 對我們專注於銷售驅動成長的評論。我們很早就意識到，不斷變化的美國市場格局應該促使我們除了繼續專注於更有針對性的專業療法之外，還要專注於服務龐大患者群體的品牌投資。我們也做出了策略決策，推進並向市場推出廣泛的生物相似藥產品組合。我們在所有這些方面都取得了良好進展。作為證據，您可以看到我們在 Prolia 和 Repatha 方面的強勁增長，以及我們在 Aimovig 方面的早期成功，這三種藥物可以治療影響全球數千萬人的疾病。我們目前也推出了首款生物相似藥，後續也將推出更多產品。此外，我們在美國以外地區的持續銷售成長，也為未來在美國的成長模式提供了範例。

With regard to U.S. pricing, in evaluating factors contributing to our reported sales growth, changes in net selling price had minimal to no impact over the last 18 months and we expect that trend to continue going forward. We've not increased the list prices of any of our medicines since the Administration's drug pricing blueprint was issued. And in May, we decided not to execute list price increases that had been planned for July. This reflects our commitment to identifying opportunities to improve affordability and access for patients. While there are no simple fixes, we want to be part of the solution.

關於美國定價，在評估促成我們報告的銷售成長的因素時，淨售價的變化在過去 18 個月中幾乎沒有產生任何影響，我們預計這一趨勢將在未來繼續下去。自從政府發布藥品定價藍圖以來，我們沒有提高任何藥品的標價。5月份，我們決定不執行原定於7月實施的商品價格上漲計畫。這反映了我們致力於尋找機會，提高病患的醫療費用可負擔性和就醫便利性的承諾。雖然沒有簡單的解決方案，但我們希望成為解決方案的一部分。

To summarize our sales performance for the quarter, we continue to generate double-digit growth, primarily driven by volume for several of our newer products and those with label expansions, such as KYPROLIS, XGEVA, BLINCYTO and Parsabiv. And once again, sales growth outside the U.S. was very strong, increasing by 9% excluding the impact of foreign exchange, driven by 14% volume growth.

總結本季銷售業績，我們持續實現兩位數成長，主要得益於幾款新產品和標籤擴展產品的銷售成長，例如 KYPROLIS、XGEVA、BLINCYTO 和 Parsabiv。再次，美國以外地區的銷售成長非常強勁，不計匯率影響，成長了 9%，這主要得益於銷量成長了 14%。

Let me now turn to our brands. Prolia delivered another outstanding quarter, with sales increasing 21% with 16% volume growth year-over-year and share gains in both the U.S. and international markets.

現在讓我來介紹一下我們的品牌。Prolia 又取得了一項出色的季度業績，銷售額同比增長 21%，銷量同比增長 16%，並在美國和國際市場均獲得了份額增長。

Moving now to oncology, let me start with KYPROLIS. KYPROLIS grew 25% year-on-year, driven primarily by our ex-U. S. business. Our European business benefited this quarter from a $27 million clinical trial purchase. Just recently, we received approval to include overall survival data from the ASPIRE study to both the U.S. and EU labels. I'm also pleased to announce we recently received reimbursement for KYPROLIS in France, and we look forward to a rapid uptake in that country.

現在我們來談談腫瘤學，先從 KYPROLIS 開始吧。KYPROLIS 年成長 25%，主要得益於我們除美國以外的業務成長。美國商業。本季度，我們歐洲業務受惠於一項價值 2,700 萬美元的臨床試驗採購。就在不久前，我們獲得了批准，可以將 ASPIRE 研究中的整體生存數據納入美國和歐盟的藥品標籤中。我也很高興地宣布，我們最近在法國獲得了 KYPROLIS 的報銷，我們期待該產品在該國迅速推廣。

XGEVA grew 14% year-over-year, primarily from volume as we expanded into multiple myeloma with our label update this January.

XGEVA 年成長 14%，主要得益於銷售成長，因為我們在今年 1 月更新了標籤，將產品擴展到了多發性骨髓瘤領域。

Turning now to Neulasta, where sales increased 1% year-over-year. We're consistent with recent trends. We saw a slight reduction in the overall market segment in the second quarter, resulting in a small decline in volume. We continue to drive the adoption of Onpro in the U.S. and exited quarter 2 at 63% share of Neulasta unit sales. Onpro's increased utilization underscores the value it provides to patients and providers, which we believe will be a clear differentiator versus the potential competition. We expect to see more global utilization of Onpro in 2018, with recent launches in Germany, the U.K., the Netherlands, Poland, Ireland and Austria. Regarding potential new entrants, we are prepared to compete even when they enter the market and have years of experience competing in the short-acting G-CSF markets across the globe as well as experience competing in select markets outside the U.S. in the long-acting GCF market. We are confident in our capabilities and we know that the reliability of quality supply is a key factor for our customers.

現在來看 Neulasta，其銷售額年增 1%。我們與近期趨勢保持一致。第二季度，我們看到整個市場細分略有下降，導致銷量小幅下滑。我們繼續推動 Onpro 在美國的普及，第二季末，Onpro 的市佔率達到 Neulasta 的 63%。Onpro 的日益普及凸顯了它為患者和醫療服務提供者帶來的價值，我們相信這將使其在與潛在競爭對手的較量中脫穎而出。我們預計 Onpro 將在 2018 年得到更廣泛的全球應用，最近在德國、英國、荷蘭、波蘭、愛爾蘭和奧地利推出。對於潛在的新進入者，即使他們進入市場，我們也做好了競爭的準備。我們在全球短效 G-CSF 市場擁有多年的競爭經驗，在美國以外的特定市場的長效 G-CSF 市場也擁有競爭經驗。我們對自己的能力充滿信心，我們知道，對於我們的客戶而言，可靠的高品質供應是一個關鍵因素。

For NEUPOGEN, we exited the second quarter holding 37% of the short-acting segment in the U.S. Some of our competitors and public officials have made statements that the U.S. biosimilar market is not working. We have a different point of view. NEUPOGEN was the first major biologic to face biosimilar competition in the U.S. The fact that a biosimilar now holds a majority of the segment in less than 3 years post-launch proves that biosimilars can find a meaningful place in the U.S. market just as they have in Europe. This also gives us confidence in the future of the Amgen biosimilar portfolio.

對紐寶根而言，我們在第二季末佔據了美國短效生物相似藥市場37%的份額。我們的一些競爭對手和政府官員曾發表聲明稱，美國生物相似藥市場運作不佳。我們有不同的觀點。紐普根是美國第一個面臨生物相似藥競爭的主要生物製劑。生物相似藥上市不到3年就佔據了該細分市場的大部分份額，這證明生物相似藥可以像在歐洲一樣，在美國市場找到重要的一席之地。這也讓我們對安進生物相似藥產品組合的未來充滿信心。

With respect to the remainder of our oncology portfolio, the combined sales of Nplate, Vectibix, IMLYGIC and BLINCYTO were $426 million in the quarter, representing 10% year-on-year growth with 11% coming from volume increases.

至於我們腫瘤產品組合的其餘部分，Nplate、Vectibix、IMLYGIC 和 BLINCYTO 在本季的總銷售額為 4.26 億美元，較去年同期成長 10%，其中 11% 來自銷售成長。

ENBREL sales declined 11% year-over-year with market growth, segment share and net selling price constant with recent trends. You'll recall that second quarter 2017 benefit from a significant inventory build creating an unfavorable year-over-year comparison. On a quarter-over-quarter basis, sales increased 18%. We continue to be pleased with the launch of ENBREL Mini with AutoTouch which have met -- was met with positive feedback from both patients and physicians. Overall, we expect fundamental drivers of ENBREL to follow the recent trends.

ENBREL 的銷售額較去年同期下降了 11%，但市場成長、細分市場佔有率和淨售價與近期趨勢保持一致。您可能還記得，2017 年第二季受益於大量庫存增加，導致年比業績不佳。與上一季相比，銷售額成長了 18%。我們對 ENBREL Mini with AutoTouch 的上市感到非常滿意，該產品已獲得患者和醫生的正面回饋。總體而言，我們預期 ENBREL 的基本驅動因素將遵循近期的趨勢。

Switching now to our ESA portfolio. EPOGEN declined 14% year-over-year due to competition and a lower net selling price driven by extended supply agreement with DaVita.

現在切換到我們的ESA產品組合。由於競爭加劇以及與 DaVita 延長供應協議導致淨售價降低，EPOGEN 年比下降 14%。

Aranesp declined 12% year-over-year, primarily driven by increased competition. We've been competing against a long-acting product in the independent and mid-sized dialysis organizations since the beginning of the year. We have volume and share-based contracts in place with some of these customers and will continue to compete on an account by account basis. We're also prepared to compete with a recently approved short-acting biosimilar in all customer segments, including hospitals and clinics. Nonetheless, we expect to lose some share in these segments once the product is available.

Aranesp 年減 12%，主要原因是競爭加劇。今年年初以來，我們一直在獨立和中型透析機構中與一種長效產品競爭。我們與其中一些客戶簽訂了基於數量和份額的合同，並將繼續逐個客戶地展開競爭。我們也已做好準備，在所有客戶群（包括醫院和診所）中與最近獲批的短效生物相似藥競爭。不過，我們預期產品上市後，在這些細分市場中會失去一些市場份額。

Let's now turn to our calcimimetics. Parsabiv has launched in several markets, including the U.S., where we have a solid uptake at the independent and mid-sized dialysis providers. Both FMC and DaVita continue to run pilots to determine the eventual treatment protocols. So looking ahead, we expect to see adoption continue to increase gradually over time.

現在讓我們來看看擬鈣劑。Parsabiv 已在包括美國在內的多個市場推出，並在美國獨立和中型透析服務提供者中獲得了良好的市場認可。FMC 和 DaVita 都仍在進行試驗研究，以確定最終的治療方案。展望未來，我們預期採用率會隨著時間的推移而逐步提高。

Turning to Sensipar. Sales declined 2% year-over-year with the launch of Parsabiv. As David mentioned, the 2018 outlook for Sensipar is still uncertain, given the ongoing litigation. It remains possible that a generic competition may enter the market later this year.

改用Sensipar。由於 Parsabiv 的推出，銷售額比去年同期下降了 2%。正如大衛所提到的那樣，鑑於訴訟仍在進行，Sensipar 2018 年的前景仍然不明朗。今年晚些時候，仿製藥仍有可能進入市場。

Repatha sales grew 78% year-over-year, primarily from volume as we continue to compete effectively maintaining a majority share on a global basis. With outcomes data added to our label in the U.S. in December and more recently, in Europe and Japan, our teams have been speaking directly to the benefits of treating patients with Repatha. We recently concluded negotiations to improve patient access in the U.S. with several payers including, but not limited to, CVS and Anthem. These payers presently represent greater than 65% of Repatha's commercial revenue. As these changes take effect in the second half of this year, we expect a proportion of commercial plans requiring documentation in the utilization management criteria to be cut in half with the rest relying on simple physician attestation. In exchange for simpler UM criteria, we have increased our rebates, which will result in a lower net price. We recognize that higher rebates unfortunately don't always result in lower out-of-pocket costs for the patients. Therefore, we continue to work with a wide range of stakeholders on continued improvement in access. We are, however, encouraged by the fact that physicians have consistently recognized the benefit of treating patients with Repatha and have demonstrated a strong demand for the drug even when faced with severe restrictions on reimbursement. Our priority remains reaching the large population of high-risk cardiovascular patients.

Repatha 的銷售額年增 78%，主要得益於銷售量的成長，因為我們繼續保持有效的競爭力，在全球範圍內保持了多數市場份額。隨著 12 月在美國的藥品標籤中添加了療效數據，以及最近在歐洲和日本的藥品標籤中添加了療效數據，我們的團隊一直在直接向患者介紹使用 Repatha 治療的益處。我們最近與包括但不限於 CVS 和 Anthem 在內的幾家支付方完成了關於改善美國患者就醫途徑的談判。這些付款方目前佔瑞百安商業收入的 65% 以上。隨著這些變更在今年下半年生效，我們預計商業計劃中需要使用管理標準文件證明的比例將減少一半，其餘部分將依靠簡單的醫生證明。為了簡化 UM 標準，我們提高了回扣，這將導致淨價降低。我們認識到，更高的回扣並不總是能降低患者的自付費用。因此，我們將繼續與各方利害關係人合作，不斷改善服務取得途徑。然而，令人鼓舞的是，醫生們一直認可使用 Repatha 治療患者的益處，並且即使面臨嚴格的報銷限制，也對該藥物表現出了強烈的需求。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。

Now on to Aimovig, the first and only therapy specifically designed to prevent migraine by targeting and blocking the CGRP receptor. Patients and physicians share our excitement for this new therapy. And as you know, we set up a hub to assist patients to gain early access to the product, while we complete negotiations with payers. This program provides a free 2-month trial of Aimovig. We have, in fact, received a large bolus of requests from the headache centers of excellence, reflecting the pent up demand for this innovative new therapy. We are busy working through these requests and expect to see the prescriptions coming through over the coming weeks. Should a patient not be approved by insurers during this 2-month period, we have a bridging program doing their negotiations to ensure that patients are not denied the drug. Negotiations with payers are progressing well and we have successfully completed contracts to obtain coverage for just under 30% of lives already. We are also excited that we launched our first biosimilar KANJINTI, a biosimilar version of Herceptin in Europe. Biosimilars represent an important growth driver for Amgen, and so far, the market is behaving as we anticipated.

接下來是 Aimovig，這是第一個也是唯一一個專門設計用於透過靶向和阻斷 CGRP 受體來預防偏頭痛的療法。患者和醫生都和我們一樣對這種新療法感到興奮。如您所知，我們設立了一個中心，幫助患者儘早獲得該產品，同時我們完成與支付方的談判。該計劃提供為期 2 個月的 Aimovig 免費試用。事實上，我們已經收到來自頭痛專科中心的大量申請，這反映出人們對這種創新療法的迫切需求。我們正在加緊處理這些申請，預計未來幾週內會收到處方。如果患者在這兩個月內未獲得保險公司的批准，我們將啟動過渡計劃，代表保險公司進行談判，以確保患者不會被拒絕用藥。與支付方的談判進展順利，我們已經成功完成了合同，為近 30% 的人獲得了保險覆蓋。我們也很高興地宣布，我們在歐洲推出了首款生物相似藥 KANJINTI，它是赫賽汀的生物相似藥版本。生物相似藥是安進公司重要的成長動力，到目前為止，市場表現符合我們的預期。

So in closing, we continue to transition our portfolio, exemplified by volume-driven growth. I'm pleased with the execution and the consistency of performance in 2018. I'm excited about the opportunities in front of us. Let me close by thanking all the Amgen staff that worked so hard to get these important products to patients and for a strong first half of 2018.

最後，我們將繼續調整我們的投資組合，以銷售驅動成長為代表。我對2018年的執行情況和表現穩定性感到滿意。我對我們面前的機會感到興奮。最後，我要感謝安進公司所有辛勤工作的員工，感謝他們為將這些重要的產品帶給患者所付出的努力，以及2018年上半年取得的強勁業績。

Let me now hand you over to Sean. Sean?

現在我把你交給肖恩。肖恩？

Thanks, Tony, and good afternoon, all. I'll begin today with our neuroscience collaboration with Novartis. Tony spoke about our U.S. launch of Aimovig and the difference it's already making for migraine patients. In addition to the U.S. approval in May, our partnership announced a CHMP positive opinion in the EU last month. And I'm pleased to announce that we recently submitted a supplemental Biologics License Application in the United States for our 140-milligram SureClick auto injector. We look forward to working closely with FDA to make this available to patients as soon as possible. Also in migraine, we expect the data from our proof-of-concept and dose-finding Phase II study of our PAC1 antibody for migraine prevention, AMG 301, to be available by the end of the year and presentation at a medical meeting in 2019.

謝謝你，東尼，大家下午好。今天我首先要談談我們與諾華公司的神經科學合作。Tony 談到了我們在美國推出 Aimovig 的情況，以及它已經為偏頭痛患者帶來的改變。除了 5 月獲得美國批准外，我們的合作夥伴上個月還宣布獲得了歐盟人用藥物委員會 (CHMP) 的積極意見。我很高興地宣布，我們最近已向美國提交了我們140毫克SureClick自動注射器的補充生物製品許可申請。我們期待與FDA密切合作，盡快讓患者能夠用上這款產品。此外，在偏頭痛方面，我們預計用於預防偏頭痛的 PAC1 抗體 AMG 301 的概念驗證和劑量探索 II 期研究的數據將於今年年底公佈，並於 2019 年在醫學會議上進行展示。

There have been a number of recent developments in Alzheimer's disease clinical programs in our industry, so I thought it would be useful to highlight our partnerships' ongoing ß-secretase inhibitor program and why we have such confidence in our approach. AMG 520, or CNP520, is a potent and selective small molecule inhibitor of BACE1, a target with strong genetic human validation from deCODE that is part of our neuroscience collaboration with Novartis. We're taking a differentiated approach with this clinical program and are currently enrolling 2 Phase III studies. In Alzheimer's disease, amyloid precursor protein cleavage products such as A-beta begin accumulating decades before symptoms present. And by the time a patient is symptomatic, A-beta accumulation has reached a plateau, and significant neurodegeneration and subsequent inflammation have already occurred. Therefore, we've always felt the potential treatment should be administered as early as is feasible in trials attempting to demonstrate disease modification. So our partnership in collaboration with the Banner Institute is focused on a population of presymptomatic cognitively normal subjects who, based on their APOE genotype and age are very highly predisposed to developing cognitive impairment. One study is enrolling approximately 1,300 APOE4 homozygotes, that is subjects with 2 copies of the APOE4 risk allele and a second study is enrolling approximately 2,000 subjects, either APOE4 homozygotes or heterozygotes, which have 1 APOE risk allele and evidence of brain amyloid calculation. While we're studying a genetically defined population, it's a large and representative one, as approximately 60% of patients who develop Alzheimer's disease have at least one of these predisposing disease alleles.

最近，我們行業在阿茲海默症臨床項目方面取得了一些進展，所以我認為有必要重點介紹我們合作夥伴正在進行的 α-分泌酶抑制劑項目，以及我們為什麼對我們的方法如此有信心。AMG 520，或 CNP520，是一種強效且選擇性的小分子 BACE1 抑制劑，BACE1 是 deCODE 的一項強有力的人類遺傳學驗證的靶點，該 deCODE 是我們與諾華公司神經科學合作的一部分。我們對這項臨床計劃採取了差異化的方法，目前正在進行 2 項 III 期研究。在阿茲海默症中，澱粉樣前驅蛋白裂解產物（如 A-β）在症狀出現前數十年就開始累積。當患者出現症狀時，Aβ 累積已經達到平台期，並且已經發生了明顯的神經退化和隨後的發炎。因此，我們一直認為，在試圖證明疾病改變的試驗中，應儘早實施潛在的治療方法。因此，我們與 Banner 研究所的合作重點是認知功能正常的無症狀受試者群體，根據他們的 APOE 基因型和年齡，他們極易患上認知障礙。一項研究正在招募約 1300 名 APOE4 純合子，即攜帶 2 個 APOE4 風險等位基因的受試者；另一項研究正在招募約 2000 名受試者，包括 APOE4 純合子或雜合子，後者攜帶 1 個 APOE 風險等位基因，並有腦澱粉樣蛋白計算的證據。雖然我們研究的是一個基因定義的群體，但它是一個龐大且具代表性的群體，因為大約 60% 的阿茲海默症患者至少攜帶一個這樣的致病基因。

We haven't been surprised by how the Alzheimer's clinical landscape has played out of late and the recent disappointments and potential signals of efficacy have not changed our overall conviction around our program, particularly that a small molecule BACE1 inhibitor administered pre-symptomatically is likely to be the best approach to address this pathway and disease.

我們對阿茲海默症臨床領域的近期發展並不感到意外，最近的失望和潛在的療效訊號並沒有改變我們對該計畫的整體信念，特別是認為在症狀出現前使用小分子 BACE1 抑制劑可能是解決該通路和疾病的最佳方法。

In oncology, I'm happy to report we've completed enrollment in 2 Phase III studies, our study of KYPROLIS + Darzalex + dexamethasone versus KYPROLIS + dexamethasone alone in relapsed or refractory multiple myeloma and our IMLYGIC combination study with KEYTRUDA in unresectable metastatic melanoma.

在腫瘤學方面，我很高興地報告，我們已經完成了 2 項 III 期研究的入組，一項是 KYPROLIS + Darzalex + 地塞米鬆與 KYPROLIS + 地塞米鬆單藥治療復發或難治性多發性骨髓瘤的研究，另一項是 IMLYGIC 與 KEYTRUDA 聯合治療不可轉移性黑色素瘤的研究。

Turning to our early-stage oncology pipeline, we've advanced a number of programs into clinical testing as reflected on Slide 26. And by the end of this year, we expect initial Phase I data from our BCMA BiTE AMG 420 in multiple myeloma and our CD33 BiTE AMG 330 in AML. We look forward to additional data from other BiTE programs over the next year or two, including both liquid and solid tumors.

再來看看我們的早期腫瘤治療產品線，我們已經將多個項目推進到臨床試驗階段，如幻燈片 26 所示。到今年年底，我們預計將獲得 BCMA BiTE AMG 420 在多發性骨髓瘤中的初步 I 期數據和 CD33 BiTE AMG 330 在 AML 中的初步 I 期數據。我們期待在未來一兩年內獲得更多來自其他 BiTE 計畫的數據，包括血液腫瘤和實體腫瘤。

We've also deprioritized AMG 224, our BCMA antibody drug conjugate based on early data reads from our AMG 224 and AMG 420 programs that support our view that our BiTE technology may be superior to current ADC technologies.

我們還降低了 AMG 224（我們的 BCMA 抗體藥物偶聯物）的優先級，這是基於我們 AMG 224 和 AMG 420 項目的早期數據讀數，這些數據支持了我們的觀點，即我們的 BiTE 技術可能優於當前的 ADC 技術。

Finally, on Nplate, we recently submitted an application in the U.S. for pediatric immune thrombocytopenia. In other regulatory news beyond the KYPROLIS update that Tony discussed, we received a Repatha label update incorporating our cardiovascular outcomes data and full approval for BLINCYTO in the EU. And Prolia was approved for the treatment of glucocorticoid-induced osteoporosis in both the U.S. and EU. Also in our bone franchise, we resubmitted our EVENITY Biologics License Application for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Finally, in our biosimilars development programs, in addition to our KANJINTI approval that Tony discussed, we received Phase III data from ABP 710, our biosimilar of REMICADE in rheumatoid arthritis that we believe demonstrates similarity to the reference product. In closing, as always, I'd like to thank our staff for continuing to deliver for patients. Bob?

最後，我們最近在美國提交了針對兒童免疫性血小板減少症的 Nplate 申請。除了 Tony 提到的 KYPROLIS 更新之外，還有其他監管方面的消息：我們收到了 Repatha 標籤更新，其中包含了我們的心血管結果數據，並且 BLINCYTO 在歐盟獲得了完全批准。Prolia 已在美國和歐盟獲準用於治療糖皮質激素引起的骨質疏鬆症。此外，在我們的骨骼產品線中，我們重新提交了 EVENITY 生物製品許可申請，​​用於治療停經後高風險骨折婦女的骨質疏鬆症。最後，在我們的生物相似藥開發項目中，除了 Tony 提到的 KANJINTI 獲批之外，我們還收到了 ABP 710 的 III 期數據，ABP 710 是 REMICADE 在類風濕性關節炎中的生物相似藥，我們認為它與參考產品具有相似性。最後，我要像往常一樣感謝我們的員工繼續為患者提供優質服務。鮑伯？

Okay. Thank you, Sean. Before we turn the call over to Q&A, Sean, if you'd like to say a few words because I guess this is your swan song earnings call. Why don't you feel free to share your thoughts and then we'll invite Dave Reese to say a few words and then open up for questions.

好的。謝謝你，肖恩。在將電話會議轉入問答環節之前，肖恩，如果你想說幾句，因為我猜這可能是你最後一次財報電話會議了。歡迎大家暢所欲言，之後我們會邀請戴夫·里斯致辭，然後開放提問環節。

Right. Well, this was, of course, an exceedingly difficult life decision for me given the wonderful experience I've had over more than 16 years at Amgen. I love the mission, the people, the science and technology and all of these are the best they've ever been, not to mention the relationships I have based on mutual trust and respect with you, Bob, and many other Amgen leaders and staff.

正確的。當然，考慮到我在安進公司超過 16 年的美好經歷，這對我來說是一個極其艱難的人生決定。我熱愛公司的使命、員工、科學和技術，所有這些都達到了前所未有的最佳狀態，更不用說我和您（鮑勃）以及安進公司的許多其他領導和員工之間建立的基於相互信任和尊重的關係了。

That said, it's rare in our industry to have the opportunity to personally hire from academia and develop over more than a dozen years such a capable individual as David Reese as a successor for head of R&D. As you all know, succession for this particular role can be very challenging. Dave is truly ready, and just as importantly, after 21 years in the industry, I'm ready for a change, likely to early biotech company creation here in this local area of California.

也就是說，在我們這個行業，有機會親自從學術界招聘，並在十多年裡培養出像大衛·里斯這樣有能力的人作為研發主管的繼任者，這種情況實屬罕見。如大家所知，這個職位的繼任者遴選可能非常具有挑戰性。戴夫確實已經準備好了，同樣重要的是，在這個行業工作了 21 年後，我也準備好做出改變，很可能是在加州當地創辦一家早期生物技術公司。

Dave's a medical oncologist who was on faculty at UCLA when I recruited him to Amgen and he served in a variety of increasingly senior roles since his hire in 2005. These have included late-stage clinical developments, Discovery and Research and as our head of Translational Sciences and oncology programs. In his last role, he's introduced all of our current pipeline into the -- of molecules into the clinic.

Dave 是腫瘤內科醫生，當我把他招募進安進公司時，他還是加州大學洛杉磯分校的教員。自 2005 年加入安進公司以來，他擔任過各種越來越高階的職位。這些工作包括後期臨床開發、發現和研究，以及擔任轉化科學和腫瘤學計畫負責人。在他上一個職位上，他把我們目前所有的研發管線都引入了臨床試驗中。

Many of you know Dave from his presence in our investor events. If not, you're going to really enjoy getting to know him. He has my full confidence and that of my team as the next head of R&D for Amgen. I will be staying around through the end of the year to ensure a smooth transition. Finally, I'd like to thank everyone at Amgen and in the investment community for the support I've received over the years. It's been a privilege to be part of the evolution of this great American company and to have such high quality interactions with our investors and analysts.

你們中的許多人都透過參加我們的投資者活動認識了戴夫。如果不是，你一定會很享受和他相處的時光。我和我的團隊對他充滿信心，相信他能勝任安進公司下一任研發主管的職位。我將留任至年底，以確保平穩過渡。最後，我要感謝安進公司和投資界的各位多年來給予我的支持。能夠參與這家偉大的美國公司的發展歷程，並與我們的投資者和分析師進行如此高品質的互動，我深感榮幸。

Dave, welcome to earnings call land. Why don't you make a few comments?

戴夫，歡迎來到財報電話會議的世界。為什麼不發表幾句評論呢？

Thank you, Sean, and thank you for your partnership. It's certainly been a highlight of my career over the last 13 years. I'd like to emphasize that we're dedicated to our core mission of advancing science for the benefit of patients. We'll continue to focus on developing medicines that produce large effect sizes in serious diseases, where there is significant unmet medical need. I've been a part of the R&D leadership team for some time as Sean mentioned, and I also believe that the commitment that we have made to using human genetics to understand the origins of disease and to suggest therapeutic interventions is the right choice and in fact will become increasingly important in our drug discovery enterprise.

謝謝你，肖恩，也謝謝你的合作。這無疑是我過去13年職業生涯中的一大亮點。我想強調的是，我們始終致力於推動科學發展，造福病人。我們將繼續專注於研發能夠對嚴重疾病產生顯著療效的藥物，以滿足尚未充分滿足的醫療需求。正如肖恩所提到的，我加入研發領導團隊已經有一段時間了，我也相信我們致力於利用人類遺傳學來了解疾病的起源並提出治療幹預措施是正確的選擇，事實上，這將在我們的藥物發現事業中變得越來越重要。

Likewise, I'm convinced that platforms such as our BiTE technology and other therapeutic modalities have the potential to deliver transformative medicines. Having led our translational sciences efforts for some time, I cannot be more excited about our preclinical and clinical pipelines. At the same time, it's undeniable that we've entered a period of remarkable technological ferment, leading to both a deeper understanding of disease and providing a wide array of new technologies that will change how we do science at the bench and advance molecules in the clinic. In light of this, I'm extraordinarily enthusiastic about the opportunities in front of us and I look forward to keeping Amgen at the forefront of this rapidly changing industry. I also very much look forward to working with all of you in the investment community as we focus on creating value through delivering our pipeline. Bob?

同樣，我相信像我們的 BiTE 技術和其他治療方式這樣的平台有潛力提供變革性的藥物。我領導轉化科學工作已有一段時間，我對我們的臨床前和臨床研發管線感到無比興奮。同時，不可否認的是，我們已經進入了一個技術快速發展的時期，這不僅加深了我們對疾病的理解，也帶來了各種各樣的新技術，這些技術將改變我們在實驗室進行科學研究的方式，並推動臨床分子療法的發展。有鑑於此，我對我們面前的機會感到無比興奮，並期待著讓安進繼續處於這個快速變化的行業的前沿。我也非常期待與投資界的各位合作，共同致力於透過推進我們的專案來創造價值。鮑伯？

Okay. Thanks, Dave. Let's open it up for questions now and I will ask our operation just to remind you of all of the procedures for doing that. Ian, over to you.

好的。謝謝你，戴夫。現在我們來開放提問環節，我先問一下操作流程，提醒大家所有相關步驟。伊恩，該你了。

(Operator Instructions) Our first question comes from the line of Ying Huang from Bank of America Merrill Lynch.

（操作員說明）我們的第一個問題來自美國銀行美林證券的黃穎。

So first one I have a high level question. You guys bought back $3.2 billion of stock in second quarter in addition to the $10 billion buyback in first quarter and then there's another plan to do $3 billion to $5 billion in second half. Does this suggest anything about your strategic thinking about M&A transactions given the large buyback? And then secondly, maybe I want to see if you have any comments on the potential entry of a Neulasta biosimilar in the second half. We saw a [line in] price at 33% discount on this price level. So what's the assumption on your second half run rate for Neulasta? And what's your defense strategy on Neulasta?

首先，我有一個比較高層次的問題。你們在第二季回購了價值 32 億美元的股票，加上第一季的 100 億美元回購，還有一項計畫在下半年再回購 30 億至 50 億美元。鑑於此次大規模股票回購，這是否暗示了您在併購交易方面的策略性思考？其次，我想聽聽您對下半年Neulasta生物相似藥的潛在進入市場有何看法。我們看到這款產品在這個價位上打了 33% 的折扣。那麼你對紐拉斯塔下半季的勝率有何預期？你們在紐拉斯特的防禦策略是什麼？

Okay, there's quite a lot there, Ying. Let's break it into 2 parts, start with David Meline in response to your question on capital allocation, and then we'll ask Tony just to reiterate what he said on the call.

好的，那裡面的東西還真不少，英。讓我們把它分成兩部分，首先請 David Meline 回答你關於資本配置的問題，然後我們請 Tony 重申他在電話會議上說過的話。

Yes. So on capital allocation, I think we've been quite clear in the past and we haven't changed our point of view, which is how we create value as an enterprise is investing in innovative medicines either internally through our own R&D efforts and also we're very active looking for opportunities externally to add to the portfolio. And so we'll continue to do that. What's also true is I think we all know that we have a tremendous capability for cash generation and we have a large amount of excess cash following tax reform and we are committed to return excess cash through time to shareholders. So I wouldn't read our ongoing repurchase activities to be anything other than following on that commitment and I would definitely not read that we're backing off from our commitment to continue to add to our pipeline and our portfolio.

是的。所以關於資本配置，我認為我們過去一直非常明確，而且我們的觀點也沒有改變，那就是我們作為一家企業創造價值的方式是投資於創新藥物，既包括透過我們自己的研發工作進行內部投資，也包括積極尋找外部機會來豐富我們的產品組合。所以我們會繼續這樣做。同樣的事實是，我認為我們都知道我們擁有強大的現金創造能力，稅制改革後我們擁有大量剩餘現金，我們致力於隨著時間的推移將剩餘現金返還給股東。因此，我認為我們持續進行的回購活動只是在履行這項承諾，我絕對不會認為我們正在放棄繼續擴充產品線和投資組合的承諾。

So as regards to the Neulasta biosimilar, I mean, clearly, we've been competing in the marketplace with NEUPOGEN and biosimilars for a number of years now. The team stands ready and able to compete. We have a long legacy and history of reliable and consistency of quality supply. We have spent quite a bit of time converting the market to the Onpro device, which is a unique and innovative device, which is beneficial for both clinical practice and for patients themselves. And I think there's quite a difference in the marketplace between the list prices of these drugs and the ASP price.

所以，關於 Neulasta 生物類似藥，我的意思是，很顯然，我們已經在市場上與 NEUPOGEN 和其他生物類似藥競爭好幾年了。球隊已做好充分準備，可以參加比賽。我們擁有悠久的可靠、穩定的優質供應歷史。我們花了大量時間將市場轉向 Onpro 設備，這是一款獨特且創新的設備，對臨床實踐和患者本身都有益處。我認為這些藥物的標價和實際銷售價格之間存在相當大的市場差異。

And our next question is from the line of Michael Yee from Jefferies.

下一個問題來自傑富瑞集團的麥可葉。

I guess, Sean, this might be your last call, so I wanted to ask you a question and that was you highlighted Alzheimer's and perhaps you could opine, obviously, on your view since you are running different studies in APOE carriers and non-carriers whether there's truly a difference there and whether there's a difference in progression and opine on the debate of course [this week.]

肖恩，我想這可能是你最後一次打電話了，所以我想問你一個問題，你重點提到了阿茲海默症，既然你正在對 APOE 攜帶者和非攜帶者進行不同的研究，那麼你或許可以就此發表一下你的看法，看看他們之間是否存在真正的差異，以及在疾病進展方面是否存在差異，當然，也請談談你對本週相關辯論的看法。

Well, Michael, I think that we've been able to utilize data that we've accumulated in Iceland through deCODE, who as you know, have done some of the really seminal breakthrough genetics in epidemiology in Alzheimer's to understand the rate of cognitive decline that occurs in patients who have 0, 1 or 2 of the APOE4 alleles and that plus age allows one to make some estimates of when people who are cognitively normal will begin to develop some cognitive impairment in the context of a disease-modifying trial. So we've had the advantage of that information and that's what led us with Novartis to move toward this kind of a genetic stratification of the population. And we again expect because we are looking at this type of enriched population that we'll be able to conduct in a feasible way these trials, which otherwise would be very difficult to conduct if you were taking patients who are cognitively normal and didn't have these high risks for conversion in the reasonably near future trying to engage in a clinical trial. So it is a differentiated approach, and I think an important one. And as I stressed before, it's not like a little proof-of-concept experiment in some tiny subset of patients with a genetic risk factor. This is 60% of the people who present with Alzheimer's disease have 1 or 2, I believe, risk alleles.

邁克爾，我認為我們已經能夠利用我們在冰島透過 deCODE 累積的數據。如你所知，deCODE 在阿茲海默症流行病學遺傳學方面取得了一些真正具有開創性的突破，從而了解攜帶 0、1 或 2 個 APOE4 等位基因的患者認知能力下降的速度。再加上年齡，我們可以對認知正常的人在疾病修飾試驗中何時開始出現認知障礙做出一些估計。因此，我們利用了這些訊息，也正是這些訊息促使我們與諾華公司一起朝著這種人口遺傳分層的方向發展。我們再次期望，由於我們關注的是這種類型的富集人群，我們將能夠以可行的方式進行這些試驗，否則，如果您招募的是認知正常且在不久的將來沒有如此高轉化風險的患者，那麼進行這些試驗將非常困難。所以這是一種差異化的方法，我認為這是一種重要的方法。正如我之前強調的那樣，這不像是在一小部分具有遺傳風險因素的患者身上進行的小型概念驗證實驗。據我所知，60%的阿茲海默症患者攜帶1個或2個風險等位基因。

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

下一個問題來自摩根士丹利的馬修·哈里森。

So before my question, let me say congratulations to Sean and Tony on their tenure and good luck if they move on and welcome to Dave. So Tony, I was hoping a question for you. You mentioned a little bit about Aimovig, I was hoping you could provide some insight into 2 factors. We're obviously seeing the scripts, but we don't really have a good idea of the translation of those scripts for free drug into revenue, so I don't know if you're willing to just give us any thoughts around how we should be thinking about the script trajectory versus your ability to generate revenue from them. And then second item is you talked about having about 30% of the lives with coverage already, could you just talk a little bit about what's the utilization management criteria that you've been able to negotiate for that? And do you think that's suggestive of the UM that we should expect for the rest of the plan?

所以在我提問之前，請允許我祝賀肖恩和托尼任期圓滿結束，如果他們之後離開，也祝他們好運，並歡迎戴夫加入。東尼，我有個問題想問你。您之前提到過Aimovig，我希望您能就以下兩個方面提供一些見解。我們當然看到了處方，但我們並不清楚如何將這些免費藥物的處方轉化為收入，所以我不知道您是否願意就我們應該如何看待處方軌跡以及您從中創造收入的能力提出一些想法。其次，您提到大約 30% 的人已經獲得了保險，您能否談談您為此協商的利用管理標準是什麼？你認為這是否預示著我們應該對該計劃的其餘部分抱持怎樣的預期？

So I want to start by saying I think from what I've seen anecdotally from both physicians and from patients, the response to Aimovig in the marketplace is beyond our expectations. So patients are really finding this to be a definitive difference in a way of managing their migraines. We knew we would have a little bit of an issue in the beginning as we have sort of put the contracts into place, so we created the hub together with Novartis to ensure all patients are referred into the hub first to allow them access if they didn't already have coverage to this 2-month free program. Right now, the majority of our business is in free drug but we are rapidly converting that business to paid prescriptions. And you'll see as the bolus comes through the hub, there's been quite a dramatic change in the number of patients that happened in the last week or so and we expect this to get back to a steady state in the next 3 or 4 weeks or so. In terms of those organizations who were visionary enough to move rapidly to give access to patients who have been struggling with this devastating disease for a long time, the UM criteria has been pretty clear. We always assume the drug we use as a second line when patients have failed on existing generic therapies and that's where it is but all the plans at the moment only require physician attestation, right. So no documentation, just the physician stating very clearly that the patient has already tried some other products.

首先我想說的是，根據我從醫生和患者那裡了解到的情況，Aimovig 在市場上的反應超出了我們的預期。因此，患者確實發現這在控制偏頭痛方面帶來了顯著的不同。我們知道一開始可能會遇到一些問題，因為我們已經簽訂了合同，所以我們與諾華公司共同創建了這個中心，以確保所有患者首先被轉診到該中心，以便那些尚未獲得這項為期 2 個月的免費計劃保障的患者能夠獲得該計劃的資格。目前，我們的大部分業務是免費藥品，但我們正在迅速將這項業務轉變為付費處方藥。你會看到，隨著藥物通過輸液港，過去一周左右患者數量發生了相當大的變化，我們預計這種情況將在接下來的 3 到 4 週內恢復穩定狀態。對於那些有遠見卓識、迅速行動，為長期與這種毀滅性疾病作鬥爭的患者提供醫療服務的組織而言，UM 的標準已經非常明確。我們總是假設，當患者對現有的仿製藥療法無效時，我們會使用一種二線藥物，情況就是這樣，但目前所有的計劃都只需要醫生證明，對吧。所以沒有任何書面記錄，只有醫生非常明確地指出，患者已經嘗試過其他一些產品。

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

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

I have a question on copay accumulator. I think last quarter, Tony, I think you indicated that you don't anticipate seeing any impact in the first half, but we're now in the thick of Q3, and for most modeling of these types of plans, it looks like much of the impact is likely to be in the summer. So I guess, maybe can you describe and also one of your big competitors actually lowered guidance for one of their drugs as a result of an impact here. Can you maybe just talk about the dynamic impacting ENBREL, in particular. I know there's a few countermeasures that you and other folks in the industry have talked about taking but maybe give an update as to how effective those countermeasures are and where things stand with this thing?

我有一個關於共付額累積器的問題。東尼，我想上個季度你曾表示預計上半年不會受到任何影響，但現在已經進入第三季度，而且對於這類計劃的大多數模型來說，大部分影響可能要到夏季才會顯現。所以我想，您能否描述一下，還有，您的一個主要競爭對手實際上因為這裡的影響而下調了其某種藥物的指導價。能否談談影響恩利（ENBREL）的動態因素？我知道您和業內其他人士已經討論過一些應對措施，但能否更新一下這些應對措施的有效性以及目前的情況？

I'm not going to talk about what the counter measures are that we've put into place, they're clearly competitive. But I have looked very closely at the potential impact of accumulative programs on ENBREL, both in the first quarter where I saw minimal to nothing and again for the second quarter, where I saw minimal to nothing and I'm not forecasting much in the third quarter, beyond.

我不打算談論我們已經採取的應對措施，它們顯然具有競爭力。但我已經非常仔細地研究了累積計劃對 ENBREL 的潛在影響，無論是在第一季（我發現影響甚微甚至沒有影響）還是在第二季度（我發現影響甚微甚至沒有影響），我預計第三季度及以後也不會有太大影響。

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

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

I figured I'll ask Tony and Sean a question each. So perhaps, first, Sean maybe just a little confused on your response to one of the prior questions on AMG 520. And I guess, what I'm asking is why not enroll noncarriers? Do you think they'll perform better and it will be harder to tease out a signal? I just want to understand why not have it in your Phase III program. And then Tony, my question to you was just to clarify how Neulasta's economics work the way it's structured currently in the face of biosimilars, and specifically, what I was looking to understand was, a, is any part of Onpro reimbursed via part D, as in David? And then also the economics, how they work for 340Bs versus clinics? And whether some part of market could be rebated more or could be more defendable, that kind of thing.

我打算分別問托尼和肖恩一個問題。所以，首先，肖恩可能對你之前關於 AMG 520 的某個問題的回答有點困惑。我想問的是，為什麼不讓非投保人投保呢？你認為它們的表現會更好，更難從中提取出訊號嗎？我只是想了解為什麼你們的第三階段方案中沒有包含這項內容。然後，Tony，我的問題只是想澄清一下，在生物類似藥出現的情況下，Neulasta 目前的經濟結構是如何運作的，具體來說，我想了解的是，a，Onpro 的任何部分是否像 David 所說的那樣通過 D 部分報銷？此外，還有經濟方面的問題，340B計畫和診所的運作方式有何不同？以及市場某些部分是否可以獲得更多折扣或更具防禦性，諸如此類的問題。

Okay. A lot of questions there, we'll try and take those one at a time.

好的。問題很多，我們會盡量逐一解答。

With respect to the strategy we're using, so the way to think about it is that we are focused on testing people before it's potentially too late to be able to show disease modification. And so we believe that means that people have to be cognitively normal on an intense battery of cognitive testing. But if you imagine bringing people in who have -- don't have a predisposing genetic driver to have them be very likely to develop the cognitive impairment in the relatively near future, you're going to be doing a study forever. So what we decided to do is basically enrich for people who have both a certain age and the APOE status that we're likely to have enough of them so people going from cognitively normal to cognitively impaired during the course of the trial that won't take forever. And given that this represents 60% of people with Alzheimer's disease, it seems like a pretty reasonable strategy to me.

就我們採用的策略而言，我們的重點是在可能為時已晚、無法證明疾病有所改變之前對人們進行測試。因此我們認為這意味著人們必須在一系列嚴格的認知測試中表現出正常的認知能力。但如果你想像一下，把那些沒有遺傳傾向的人——他們不太可能在不久的將來出現認知障礙——納入研究，那麼這項研究將永遠沒完沒了。因此，我們決定主要針對那些既有一定年齡又有 APOE 基因型的人進行研究，這樣我們就能有足夠多的這類人群參與試驗，從而使那些在試驗過程中從認知正常發展到認知受損的人不會花費太長時間。考慮到這佔阿茲海默症患者的 60%，在我看來，這似乎是一個相當合理的策略。

So as regards Neulasta, Umer, all of Neulasta is part B. Nothing is in Part D. From a reimbursement perspective, part B is obviously under ASP +. Your ASP depends on what your prices are today and what they'll evolve to be in a few quarters' time. As Amgen, as a company, we've always presented our position very strongly to both the environment and to CMS and the government that we prefer a level playing field between ourselves and biosimilars in the future and allow normal competitive factors in the marketplace to allow us to compete equally.

關於Neulasta，Umer，Neulasta的所有產品都屬於B部分，不屬於D部分。從報銷的角度來看，B部分顯然屬於ASP+的範疇。您的ASP取決於您目前的價格以及未來幾季的價格走勢。作為安進公司，我們一直以來都向環境、CMS和政府明確表明我們的立場，即我們希望未來我們與生物類似藥之間能夠擁有公平的競爭環境，並允許市場上的正常競爭因素使我們能夠公平競爭。

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

下一個問題來自高盛的 Terence Flynn。

Best of luck to Sean and Tony on next steps and congrats to Dave. Maybe first just for Tony on Repatha, I was wondering what percent of lives now have the eased utilization management criteria? And with the new treatment guidelines expected later this year, do you think that'll have a further impact on access? And then maybe just for Sean on AMG 301, you mentioned the PAC1 antibody, what are you hoping to see from this Phase II trial? And if it's positive, could you move right into Phase III?

祝福肖恩和東尼在接下來的事情中一切順利，也祝賀戴夫。或許首先只是針對服用瑞百安（Repatha）的托尼，我想知道現在有多少比例的人符合放寬後的用藥管理標準？預計今年稍後將推出新的治療指南，您認為這會對醫療服務取得產生進一步影響嗎？還有，Sean，在 AMG 301 節目中，你提到了 PAC1 抗體，你希望從這項 II 期試驗中看到什麼？如果結果呈陽性，可以直接進入第三階段嗎？

Okay, got a couple of questions there. Repatha, the utilization management question and how guidelines may affect...

好的，我還有幾個問題。Repatha，其利用管理問題以及相關指南可能產生的影響…

So as I said, about 65% of our business at the moment is going to move towards -- attestation only. And in terms of total evolution of commercial business, that's probably between 25% and 40% of the total lives available. I think as we continue to negotiate the other plans, we will get better utilization management criteria. I do believe we're going to get better access. The drug is proving to be something that physicians and cardiologists are prescribing consistently continually and the demand from patients is still there.

正如我所說，目前我們約 65% 的業務將轉向——僅提供認證服務。就商業發展的整體進程而言，這可能占到可用總壽命的 25% 到 40%。我認為，隨著我們繼續就其他方案進行談判，我們將獲得更好的利用率管理標準。我相信我們會獲得更好的獲取途徑。事實證明，醫生和心臟科醫生一直在持續開立這種藥物，而且患者的需求仍然存在。

And Terence, for AMG 301, our PAC1 antibody receptor antagonist, it -- we are doing something very similar to what we did with Aimovig where the proof of concept trial also includes dose ranging all predicated on some dermal blood flow assays that were done in healthy subjects to pinion the dose ranging. So if we're successful in demonstrating proof-of-concept, hopefully, we also would have enough dose information to be able to proceed directly into Phase III as we were able to do with Aimovig. But of course, we'll see. This is a novel pathway that needs to be validated in humans through this experiment.

Terence，對於我們的 PAC1 抗體受體拮抗劑 AMG 301，我們正在做與 Aimovig 非常相似的事情，概念驗證試驗也包括劑量範圍，所有這些都基於在健康受試者中進行的一些皮膚血流測定來確定劑量範圍。因此，如果我們成功地證明了概念，希望我們也能獲得足夠的劑量信息，從而能夠像我們對 Aimovig 所做的那樣，直接進入 III 期臨床試驗。當然，我們拭目以待。這是一條全新的途徑，需要透過這項實驗在人體中進行驗證。

And our next question is from Geoffrey Porges from Leerink Partners LLC.

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

Congratulations to Tony and Sean. One quick question on perhaps, Bob, on rebates. Could you give us a sense of what impact elimination of the Safe Harbor for rebating would have on Amgen's products access and price. And then I hate to sort of pursue this Alzheimer's question again, but Sean, could you talk, as you're sort of looking at leaving Amgen, what are the barriers to doing -- exploring all the sensible combination ideas that might be out there in Alzheimer's given all the frustration that the industry has had with single product trials?

恭喜托尼和肖恩。鮑勃，關於退款，我還有一個問題想問。您能否簡要說明一下，取消回扣安全港條款會對安進產品的市場准入和價格產生什麼影響？然後，我不太想再問阿茲海默症的問題，但是肖恩，鑑於你正在考慮離開安進，你能談談在探索阿茲海默症領域所有合理的聯合療法方面，有哪些障礙嗎？畢竟，整個產業在單一產品試驗方面都遇到了許多挫折。

Okay, Geoff, maybe we'll answer your rebate question in 2 parts. I'll start, and then Tony, you can jump in. Big picture, Geoff, as you know, the discussion about rebates is underway. The Administration has asked for perspectives and we've participated with our industry colleagues in sharing our thoughts about this. We think that the Administration is focusing on an important topic here, which is rebates and the impact that the rebate structure in our industry has on patient affordability, so we welcome an opportunity to be able to share our industry perspectives with decision-makers and the government, and that process is underway. It's a little bit premature, I think, to talk about what the specifics in your question were on our business, but I'll invite Tony to share his thoughts.

好的，傑夫，或許我們可以分兩部分來回答你的退款問題。我先開始，然後托尼，你可以接著說。傑夫，從大局來看，正如你所知，關於退款的討論正在進行中。政府徵求意見，我們與業內同行分享了我們對此的看法。我們認為，政府關注的重點是一個重要議題，即回扣以及我們行業的回扣結構對患者負擔能力的影響，因此我們歡迎有機會與決策者和政府分享我們行業的觀點，而這一過程正在進行中。我覺得現在談論你問題中關於我們業務的具體細節還為時過早，但我會邀請托尼分享他的想法。

So, maybe I can add to what Bob was saying, it's clearly in competitive markets, rebates tend to be higher. And so the gap between your list price and your net price tends to get quite large. None of which allows patients to benefit from it, of course, because they're paying co-pays, coinsurance or deductibles based on the list price. If the rebates went away by definition, your list prices would get closer to net prices and patients would be able to access drugs better.

所以，我或許可以補充鮑伯的觀點，很明顯，在競爭激烈的市場中，折扣往往更高。因此，標價和淨價之間的差距往往會變得相當大。當然，這些措施都無法讓患者從中受益，因為他們需要根據標價支付共付額、共同保險或自付額。如果取消回扣，藥品標價自然會更接近淨價，患者也能更好地獲得藥品。

And one maybe one last thought, sorry, Geoff, and then we'll kick to Sean. Rebates and the structure that exists today evolved over many decades. It's hard to imagine how -- what the impact of unraveling that would be if that unraveling occurred quickly. But again, part of the discussion, we look forward to trying to figure out whether there's a better way for patients than what's in place today. Sean?

最後還有一點，抱歉了，傑夫，然後我們就把球交給肖恩。退稅及其現行結構是經過數十年的發展演變而來的。很難想像，如果這種瓦解迅速發生，會造成怎樣的影響。但作為討論的一部分，我們期待著弄清楚是否有比目前的方法更好的方法來造福患者。肖恩？

Yes, I mean, it's a great question, Geoff. I think that what I would say is that it's difficult given the costs and complexity and duration of these kind of trials to imagine going directly into combination without having demonstrated some efficacy and safety of the individual interventions. And I think there is a very strong logic behind combination in the disease because we know from the human genetics that one problem is APP processing and degeneration of fragments like A-beta and then another problem the way in which the glial cells in the brain handle the subsequent cell detritus and death and inflammation. And that's pretty clear from the genetics, which has largely been elucidated by deCODE. And so we think that we'll get there and that there will be combination therapy but we probably need to see that the individual -- one of the individual components validated and then you'll see people adding on to that therapy to try and see more dramatic impact on disease progression.

是的，我的意思是，傑夫，這是一個很好的問題。我認為，考慮到這類試驗的成本、複雜性和持續時間，很難想像在沒有證明單一幹預措施的有效性和安全性的情況下直接進行聯合治療。我認為這種疾病的組合背後有著非常強烈的邏輯，因為我們從人類遺傳學中得知，一個問題是 APP 加工和 A-β 等片段的退化，另一個問題是大腦中的神經膠質細胞如何處理隨後的細胞碎片、死亡和發炎。從遺傳學角度來看，這一點已經很清楚了，而 deCODE 技術已經對此進行了很大程度的闡明。因此我們認為我們會實現這一目標，並且會出現聯合療法，但我們可能需要先驗證其中某個組成部分的有效性，然後人們才會將其他療法添加到該療法中，以期對疾病進展產生更顯著的影響。

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

下一個問題來自花旗銀行的 Robyn Karnauskas。下一個問題來自巴克萊銀行的傑夫·米查姆。

Just a question on health care policy. I know there's been a lot of talk about with respect to biosimilars interchangeability. And Tony, I want to get your perspective on maybe how close we are on that? And then the other issue is Part B to Part D conversions sort of demo project, kind of what your thoughts are on that?

關於醫療保健政策，我有個問題。我知道關於生物類似藥互換性的討論很多。東尼，我想聽聽你對我們距離目標還有多遠的看法？另一個問題是B部分到D部分的轉換，類似於演示項目，您對此有什麼想法？

Okay. Maybe we'll ask Sean to talk about the appropriateness of interchangeability from a regulatory standpoint first, Jeff, and then Tony, feel free to add any thoughts you have.

好的。或許我們可以先請肖恩從監管角度談談互換性的合理性，傑夫，然後托尼，你也隨時可以補充你的想法。

Yes. I mean, I think, obviously, there are 2 aspects to this. There's the regulatory piece which varies from country to country. In the U.S., the -- as you probably know, the agency has provided reasonably clear guidance around what's necessary to achieve the interchangeability. But that hasn't really been put into practice yet. If people are doing trials that are designed to meet that standard, no one's having approval based on it yet, so there's a learning curve there. But that will be an important goal that some companies will pursue with their products. Then there's the question of whether there may be, if you will, interchangeability policies that will exist at the level of payers and who can potentially do whatever they want independent of the regulatory component that, Tony, maybe you could comment on.

是的。我的意思是，顯然，我認為這件事有兩個面向。監管方面也存在差異，各國情況不盡相同。在美國，正如您可能知道的那樣，該機構已經就實現互換性所需的條件提供了相當明確的指導。但這尚未真正付諸實踐。如果人們正在進行旨在達到該標準的試驗，但目前還沒有人因此獲得批准，所以這方面還有一個學習過程。但這將是一些公司希望透過其產品實現的重要目標。那麼，還有一個問題，那就是支付方層級是否會存在所謂的互換性政策，他們可以不受監管因素的影響，為所欲為。東尼，也許你可以就此發表一下看法。

As I said, NEUPOGEN to us is probably the best example of the existing system allowing biosimilars to access the marketplace. After 3 years, they hold the majority market share, and therefore, we continued to put forth our proposal that the market be left as is, that we keep the playing field level, that we allow the normal competitive framework of the marketplace to take place.

正如我所說，對我們來說，NEUPOGEN 可能是現有體系允許生物相似藥進入市場的最佳例證。三年後，他們佔據了大部分市場份額，因此，我們繼續提出我們的建議，即保持市場現狀，保持公平競爭，允許市場正常的競爭框架發揮作用。

[And talking] about B to D, the -- I'm not so sure as to exactly what you're getting at Geoff, but obviously, one of the things that's being discussed in Washington is whether it makes sense to consider the movement of certain drugs from part B to D and, again, the early stages of discussions about what that would look like and for which products it will be relevant, so premature I think to speculate about whose products are being included in that over what time and what impact.

[說到] B 類藥物轉 D 類藥物——傑夫，我不太確定你到底想表達什麼，但顯然，華盛頓正在討論的事情之一是，是否應該考慮將某些藥物從 B 類藥物轉入 D 類藥物。而且，關於轉入 D 類藥物的具體形式以及哪些產品會受到影響的討論還處於早期階段，所以我認為現在就猜測哪些產品會在多長時間內被納入 D 類藥物的範疇以及會產生什麼影響還為時過早。

And our next question is from the line of Cory Kasimov from JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

Also let me add my congratulations to Sean and Tony on the retirements as well as to David on his well-deserved promotion. So the question is for Sean. And I wanted to ask about BCMA and kind of what you see is the bar in your ongoing Phase I trials. And I know you're looking at your products more as monotherapy assets or as part of existing combinations down the road?

另外，我還要祝賀肖恩和東尼退休，以及大衛榮升，這是他應得的。所以這個問題要問肖恩。我想問關於 BCMA 的問題，以及您在正在進行的 I 期試驗中看到的指標。我知道你們更多是將產品視為單一療法資產，還是未來作為現有聯合療法的一部分？

Yes. I think this antigen is going to likely prove to be fairly transformative in the disease. And the question becomes the modality that you go after it with, as I mentioned, we're less impressed with what we're seeing with the ADCs and the BiTE technology appears to be capable of generating early data small numbers of patients with very dramatic results. Whether some -- you gain anything from a cell-based therapy directed against this antigen nobody knows because there's no -- not even a way to do an indirect comparison at this point let alone any kind of direct comparison, so it will be really interesting. I think, of course, initially, we'll be studying it as a monotherapy in patients who are in late stage and have undergone many rounds of attempts to treat the disease. But one could easily imagine a therapy like this entering all lines of therapy and including attempts to cure the disease in first-line settings. Dave, you may want to comment further.

是的。我認為這種抗原很可能會對這種疾病產生相當大的變革性影響。問題就變成了你採用哪種治療方式，正如我所提到的，我們對ADC的療效不太滿意，而BiTE技術似乎能夠從小樣本患者中獲得非常顯著的早期數據。針對這種抗原的細胞療法是否能帶來任何益處，目前尚無人知曉，因為甚至連間接比較的方法都沒有，更不用說任何形式的直接比較了，所以這將非常有趣。當然，我認為，最初我們會將其作為單一療法，用於治療晚期患者，這些患者已經嘗試過很多輪治療這種疾病。但人們很容易想像，這樣的療法可以應用於所有治療領域，包括在一線治療中嘗試治癒這種疾病。戴夫，你可能還想再補充一些內容。

Yes. It's a very good question. We would anticipate the initial forays to be as monotherapy, but there are a variety of potential biologic combinations that makes sense and we will plan to also aggressively develop those over time as Sean mentioned earlier, we are hoping to present publicly sometime later in the year on some of the first clinical data from these programs.

是的。這是一個很好的問題。我們預計最初的嘗試將以單藥療法為主，但各種潛在的生物製劑組合都是合理的，我們將計劃隨著時間的推移積極開發這些組合。正如肖恩之前提到的，我們希望在今年稍後公開展示這些項目的首批臨床數據。

And our next question from Kennen MacKay from RBC Capital Markets.

接下來，我們向加拿大皇家銀行資本市場的 Kennen MacKay 提問。

A quick one on the EVENITY resubmission. I was wondering just how you were thinking about this internally. There's obviously, some hope, at least on the Street, that the independent blinded re-review would suggest some kind of mis adjudication of events which may really help the resubmission. And then secondly, on Neulasta, I just wanted to get your perspective on sort of the strength of the Onpro defense of the hospital protocol has changed. I know a lot of time and effort went into getting Onpro onto hospital protocols. I was just hoping to get your perspective as to how large of a barrier this is, for instance, how challenging it is to be -- to be changed to Mylan's generic?

關於 EVENITY 重新提交的問題，簡單說明一下。我想知道你內心是怎麼考慮這件事的。顯然，至少在華爾街，人們抱持一些希望，認為獨立的盲審會發現一些事件的誤判，可能會對重新提交有所幫助。其次，關於 Neulasta，我只是想了解您對 Onpro 的辯護力度以及醫院協議變化的看法。我知道為了讓Onpro進入醫院的診療流程，投入了大量的時間和精力。我只是想了解您對這究竟有多大的障礙有何看法，例如，改用邁蘭的仿製藥有多困難？

Well we'll have Sean answer the first question and Tony, if you take the second question.

好，我們讓肖恩回答第一個問題，東尼，如果你來回答第二個問題的話。

So with respect to EVENITY, we did a very comprehensive scouring of the clinical databases and then re-adjudicated all of the events that were originally identified, plus any that have been identified subsequently. The good news is it showed that our research platform is very robust because when we re-did this, we saw pretty much the same thing we did last time that we did it originally. The bad news is that it didn't really change the data set for the potential safety signal. It is the opinion, and this is just an opinion, of the people involved both at Harvard and here at Amgen that the most likely explanation for the finding in the Alendronate-controlled trial is chance. We think that's most likely. However, that's not going to be good enough to mean that you're not going to have a need to warn patients about a potential risk. And I think we are sort of back where we were before we did the exercise.

因此，對於 EVENITY，我們對臨床資料庫進行了非常全面的審查，然後重新裁定了最初確定的所有事件，以及隨後確定的任何事件。好消息是，這表明我們的研究平台非常穩健，因為當我們重新進行這項研究時，我們看到的結果與上次最初進行這項研究時的結果幾乎相同。壞消息是，它並沒有真正改變潛在安全訊號的資料集。哈佛大學和安進公司相關人員一致認為（這只是個人觀點），阿崙膦酸鈉對照試驗的結果最可能的解釋是偶然因素。我們認為這最有可能。然而，這並不足以意味著你不需要警告患者潛在的風險。我認為我們現在的情況又回到了練習之前的狀態。

And then on to your question on Neulasta Onpro. To remind you again that all the institutions are working as hard as anyone else is to improve on efficiencies of the processes. Mostly large teaching institutions took about 12 to 18 months to change the clinical practice because it does apparently take some time to change clinical practice in a large institution. The benefit of this one of course is it changes that entire protocol of how you treat a patient, how many times a patient has to come back to an institution, how many times the oncology pharmacist has to be remixing, how many times the oncology nurse has to be infusing and how many times the oncologist has to be there, which is all on top of the fact that a lot of patients live far from a hospital and have a problem to come back the next day, when they are suffering from the side effects of high-dose chemo. So what we've delivered is not just a unique opportunity to give better benefits to patients who can spend more time at home or going to have a drug administered at home, but we've also taken out a huge amount of inefficiency in the institutions, which allows the nurses, the oncologists and the pharmacist to go and do something else. So one assumes that the value we bring is more than just the drug itself, it's truly an augmented value and we believe that's fairly sticky.

接下來回答你關於Neulasta Onpro的問題。再次提醒各位，所有機構都在像其他人一樣努力工作，以提高流程效率。大型教學機構通常需要 12 到 18 個月的時間來改變臨床實踐，因為在大型機構中改變臨床實踐顯然需要一些時間。當然，這種方法的優點在於它改變了治療病人的整個流程，減少了病人需要返回醫院的次數，腫瘤藥劑師需要重新配藥的次數，腫瘤護士需要輸液的次數，以及腫瘤科醫生需要到場的次數。此外，許多病人居住地離醫院很遠，在遭受高劑量化療副作用的折磨時，隔天再回到醫院也很困難。因此，我們不僅為患者提供了一個獨特的機會，讓他們能夠花更多的時間待在家裡或在家接受藥物治療，從而獲得更好的福利，而且還消除了醫療機構中大量的低效環節，使護士、腫瘤學家和藥劑師能夠去做其他事情。因此，人們認為我們帶來的價值不僅僅是藥物本身，而是一種真正的增值，我們相信這一點相當牢固。

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

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

Just one on Repatha. In the prepared remarks, you mentioned that price was going down because the agreements that have recently been signed. Can you talk a little bit about the time course of that decline in price, when did it start? Did it start in Q2 or is it starting on July 1? And when will price stabilize again?

Repatha 上只有一輛。在事先準備好的演講稿中，你提到價格下降是因為最近簽署了一些協議。您能否談談價格下跌的時間進程，它是什麼時候開始的？是從第二季開始，還是7月1日開始？價格何時才能再次穩定下來？

So the list price hasn't changed. Some of the rebates by contract have changed. Some of the newer contracts become effective July 1, and we clearly happen to be competitive in the marketplace to maintain these contracts.

所以標價沒有變化。部分合約返利條款已變更。部分新合約將於7月1日生效，而我們顯然在市場上具有競爭力，能夠維持這些合約。

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

我們的下一個問題來自瑞銀集團的卡特古爾德。

I guess for Sean and David, coming back to the BCMA question. How should we be thinking about 420 relative to 701? I mean, is there any sort of differentiation other than the half-life format? And then sort of, I guess, is 420 just sort of proof-of-principle and the strategy would be to switch to 701?

我想對於肖恩和戴維來說，還是回到BCMA的問題上來吧。我們該如何看待 420 相對於 701 的關係？我的意思是，除了半衰期格式之外，還有其他差異嗎？然後，我猜，420 只是概念驗證，而策略是切換到 701？

Dave, why don't you?

戴夫，你為什麼不呢？

Thanks for the question and it's a good one. 420, as you may know, advanced into the clinic earlier than 701. And so our intent at this time is to continue advancing both molecules until such time as we've generated data sets definitive enough for us to make a decision. All things being equal, of course, we'll take forward the half-life extended molecule.

感謝你的提問，這是一個很好的問題。如您所知，420 比 701 更早進入臨床階段。因此，我們目前的目標是繼續推進這兩種分子的研發，直到我們獲得足夠明確的資料集，以便做出決定。當然，在其他條件相同的情況下，我們會選擇半衰期延長的分子。

And our next question is from the line of [Ronnie Gal] from Bernstein.

下一個問題來自伯恩斯坦的[羅尼·加爾]。

So we're talking about biosimilar, let me just ask something there. First, Tony, I was wondering about your Herceptin subcu in Europe since you're launching the molecule, do you think that segment of the market will be protected from biosimilar competition? Or do you think this is accessible? And then in the United States, I noticed you've signed off agreements with various providers around oncology, and I was wondering do those agreements provide economic advantages for those providers to continue to use Neulasta over the biosimilar over the duration of the agreement?

既然我們在討論生物相似藥，那我就問個問題吧。首先，Tony，我想問一下你在歐洲推出的赫賽汀皮下注射劑的情況，你認為這部分市場能否免受生物相似藥的競爭？或者你認為這很容易理解嗎？然後，我注意到您在美國與多家腫瘤治療機構簽署了協議，我想知道這些協議是否能為這些機構提供經濟優勢，使他們在協議有效期內繼續使用Neulasta而不是生物類似藥？

Okay, so any innovative SKU to any product of course makes the entry of the biosimilar a little bit more difficult. It doesn't make it impossible, so we're watching all those segments in Europe as we speak right now. And then as regards to Neulasta and our customers in the U.S., we have fairly strong relationships with our customers and we have continued to work hard to maintain and to expand those good relationships, yes.

好的，任何產品的創新 SKU 當然都會使生物類似藥進入市場變得更加困難。但這並不意味著不可能，所以我們現在正在關注歐洲的所有相關報告。至於 Neulasta 和我們在美國的客戶，我們與客戶保持著相當牢固的關係，我們也一直在努力維護和拓展這些良好的關係，是的。

And our next question is from the line of Jim Birchenough from Wells Fargo Securities.

下一個問題來自富國證券的吉姆·伯奇諾夫。

I'm just wondering if you'd be willing to give any further detail on patients in the hub for Aimovig whether you'd quantify those patients or give us a better sense of how many patients may be queued up in this bolus that may be coming?

我只是想問一下，您是否願意提供更多關於Aimovig中心患者的詳細信息，例如您能否量化這些患者的數量，或者讓我們更好地了解一下可能有多少患者正在排隊等待即將到來的這劑大劑量注射？

So we haven't made that public yet. We're trying to make sure that we understand how unique each of those patients are coming in and that there are appropriate patients. I would say that as you watch the evolution of the prescriptions coming out of that, you start getting a feel of the size of the bolus. So it's well past 6:00 p.m. on the East Coast. Why don't we take 2 last questions?

所以我們還沒有公開這件事。我們正在努力確保我們了解每位患者的獨特性，並確保收治的患者都是合適的。我想說，當你觀察由此產生的處方演變過程時，你就會開始對大劑量注射的大小有所了解。現在已經過了下午6點。在東海岸。我們何不回答最後兩個問題呢？

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

我們的下一個問題來自瑞穗銀行的 Salim Syed。

Just one on Aimovig, probably for Tony. Tony, I was wondering if you can speak to when we're thinking about Aimovig longer-term past this bolus here, what are the potential bottlenecks that you're seeing? Do you think that this is an area where you'll have to get reimbursements at the PCP level in order to not have a bottleneck in the system? And also, the neurologists that are treating, do they have additional capacity to take in additional patients?

Aimovig上只有一張，可能是給Tony的。Tony，我想請你談談，當我們考慮在這次注射之後長期使用 Aimovig 時，你認為可能存在的瓶頸是什麼？你認為在這個領域，是否需要向初級保健醫生 (PCP) 申請報銷，以避免系統出現瓶頸？此外，負責治療的神經科醫師是否還有能力接收更多病人？

So there are about 20 headache specialty centers around the country at the moment, and the volume of patients they can take in depends on how much they expand over time or not. But I'd say it's a large number of patients coming through them. And then there are another a couple of thousand neurologists who clearly are prescribers but I do believe that the role of primary care physicians down the road becomes important. They do see patients and their ability to refer patients who are appropriate for a drug like Aimovig would be critical for the long term, I guess.

目前全國約有 20 家頭痛專科中心，它們能夠接收的患者數量取決於它們是否隨著時間的推移擴張。但我認為前來就診的患者數量相當多。此外，還有數千名神經科醫生顯然是處方醫生，但我相信，從長遠來看，初級保健醫生的角色會變得非常重要。他們確實會接診病人，而且我認為，他們能否將適合使用 Aimovig 這類藥物的病人轉診出去，對於長遠發展至關重要。

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

最後一個問題來自羅伯特·W·貝爾德的布萊恩·斯科尼。

I just wanted a question on the pipeline on AMG 301 for migraine prevention. I was wondering if you could just kind of help us understand the role that you guys see at PAC1 versus CGRP? And if successful, how do you kind of envision these being used, separately or a possibility for a combination down the line?

我只是想問一下關於AMG 301預防偏頭痛的治療方案的問題。我想請你們幫我們理解一下，在PAC1和CGRP這兩個組織中，你們認為它們各自的角色有何不同？如果成功，您設想這些技術將如何應用？是單獨使用，還是將來有可能組合使用？

I guess, what I would say, this is Sean, is that the thing I'd stress is that these appear to be rather independent neural pathways in the system that -- and so if it works, if PAC1 inhibition works, one would expect that it's not likely that it's going to be kind of redundant to CGRP, so you could imagine situations in which patients who are poor responders to CGRP inhibition might respond to PAC1 or that the 2 together might give better efficacy assuming that was tolerable. But that will all have to be figured out in the clinic and we're just in the first step of trying to understand whether as monotherapy we can see efficacy of the PAC1 pathway in the first place.

我想說的是，我是肖恩，我想強調的是，這些似乎是系統中相當獨立的神經通路——因此，如果PAC1抑製劑有效，人們會預期它不太可能與CGRP抑製劑產生冗餘，所以你可以想像，對CGRP抑製劑反應不佳的患者可能對PAC1抑製劑有反應，或者假設耐受性良好，兩者聯合使用可能會有更好的療效。但這一切都需要在臨床上加以驗證，我們現在只是處於嘗試了解 PAC1 路徑作為單一療法是否有效這一第一步。

Okay, Ian. Well, thanks. Let me just say a couple of quick remarks. Obviously, we're encouraged by the strong start we've enjoyed through the first half of 2018 and hope our investors share our optimism for the long-term prospects of the business through the growth we expect from our new and recently launched products as well as our biosimilars and innovative pipeline. And finally, I would be remiss if I didn't take a moment to thank our staff for their continuing focus on our mission which is to serve patients with innovative medicines and make a big difference for serious disease. So thank you to all our staff for their focus, the results of which you see in our report through the first 6 months. Looking forward to talking to all of you in October. Thank you.

好的，伊恩。謝謝。我只想簡單說幾點。顯然，我們對 2018 年上半年取得的強勁開局感到鼓舞，並希望我們的投資者和我們一樣，對公司長期前景充滿樂觀，我們預期新產品、近期推出的產品、生物類似藥以及創新產品線將帶來成長。最後，如果我不花點時間感謝我們的員工，感謝他們一直以來對我們使命的專注，那就是用創新藥物服務患者，為重大疾病帶來巨大改變。因此，感謝我們全體員工的專注付出，您可以在我們前 6 個月的報告中看到他們的成果。期待十月能和大家見面。謝謝。

Thanks all for your participation. If we didn't get to your question, feel free to call us. The IR team will be standing by for several hours. Thanks again.

感謝大家的參與。如果您的問題沒有得到解答，請隨時致電我們。IR團隊將待命數小時。再次感謝。

Ladies and gentlemen, we thank you for joining us for Amgen's Second Quarter 2018 Financial Results Conference Call. You may now disconnect.

女士們、先生們，感謝各位參加安進公司2018年第二季財務業績電話會議。您現在可以斷開連線了。