美國安進 (AMGN) 2016 Q1 法說會逐字稿

My name is Jake Wong and I will be your conference facilitator today for Amgen's first-quarter 2016 financial results conference call.

我叫 Jake Wong，今天我將擔任安進公司 2016 年第一季財務業績電話會議的主持人。

(Operator instructions)

（操作說明）

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

Thank you, Jake. Good afternoon, everybody. I would like to actually begin by extending my gratitude to all of you for having to deal with the deluge of earnings reports from multiple companies reporting today. I appreciate you being on our conference call to review our operating performance for the first quarter of 2016.

謝謝你，傑克。大家下午好。首先，我要感謝各位，感謝你們今天不得不處理多家公司發布的鋪天蓋地的財報。感謝您參加我們的電話會議，共同回顧我們 2016 年第一季的營運表現。

We're off to a great start for the year and to review our progress, Bob Bradway, our Chairman and CEO, will lead the call with a strategic overview. Our CFO, David Meline, will then review our quarterly results and update you on our guidance for 2016. Tony Hooper, our Head of Global Commercial Operations, is here to discuss our product performance during the quarter, followed by our Head of R&D, Sean Harper, who will provide a pipeline update.

今年我們開局良好，為了回顧我們的進展，我們的董事長兼執行長鮑勃布拉德韋將主持電話會議，進行策略概述。我們的財務長大衛梅林隨後將審查我們的季度業績，並向您報告我們對 2016 年的業績展望。我們的全球商業營運主管托尼·胡珀將在此討論我們本季的產品表現，隨後我們的研發主管肖恩·哈珀將提供產品線最新進展。

We will use slides for our presentation today. These slides have been posted on our website and a link was sent to you separately by email.

我們今天將使用幻燈片進行演示。這些幻燈片已發佈在我們的網站上，並且我們已透過電子郵件單獨向您發送了連結。

Our comments today will be governed by our Safe Harbor statement which in summary says that through the course of our presentation and discussion today, we may make certain forward-looking statements and actual results may vary materially.

我們今天的發言將受我們的「安全港聲明」約束，該聲明簡而言之就是，在今天的演示和討論過程中，我們可能會做出某些前瞻性陳述，而實際結果可能會與這些陳述存在重大差異。

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

那麼，接下來我將把電話交給鮑伯。鮑伯？

Thank you, Arvind, and let me also thank our listeners for joining the call. As Arvind said, we're off to a strong start in 2016 with 10% revenue growth and 17% adjusted earnings-per-share growth in the first quarter. Our sales were strong in the US and internationally and that was true broadly across our products.

謝謝你，Arvind，也請允許我感謝各位聽眾參與本次電話會議。正如 Arvind 所說，我們在 2016 年開局強勁，第一季營收成長 10%，調整後每股盈餘成長 17%。我們在美國和國際市場的銷售業績都很強勁，而且我們所有產品的整體銷售情況都很好。

As you can see from these results, we've put the Company in a strong position to manage competition for our legacy products while investing for growth with our newly launched and late stage pipeline products. Last year as you know, we had six launches in the US. We expect these products and especially Kyprolis and Repatha to pave the way for our long-term growth. We'll talk more about these launches and our priorities for them on this call.

從這些結果可以看出，我們已經使公司處於有利地位，能夠應對傳統產品的競爭，同時投資於我們新推出的和處於後期研發階段的產品，以實現成長。如您所知，去年我們在美國進行了六次產品發布。我們期望這些產品，特別是 Kyprolis 和 Repatha，能夠為我們的長期發展鋪平道路。我們將在本次電話會議上詳細討論這些產品發布以及我們對它們的優先考慮事項。

If last year was a year of launches in the US, this will be a year of launches for us internationally as we take Repatha, Kyprolis and our other new products into countries around the world. In total this year, we are expecting on the order of 80 new launches across our countries and products. For example, Repatha is launching now in Japan, Brazil, in multiple countries in Europe, and the early signs are good. Similarly, Kyprolis is off to a strong early start in its first markets in Europe.

如果去年是美國市場新品上市之年，那麼今年將是我們在國際市場新品上市之年，我們將把 Repatha、Kyprolis 和其他新產品推向世界各國。今年，我們預計在全國各地推出約 80 款新產品和新產品。例如，Repatha 目前在日本、巴西和歐洲多個國家上市，早期跡象良好。同樣，Kyprolis 在歐洲的首批市場也取得了強勁的開局。

Our oncology and cardiovascular franchises received a lot of visibility last year owing to the flow of data in our product launches in these areas. This year we expect attention to focus on our other franchises as well as our pipeline advances with important new opportunities. In bone health, for example, our Romosozumab opportunity is coming into focus with positive Phase 3 data.

去年，由於我們在腫瘤和心血管領域推出的產品帶來了大量數據，我們的這兩個業務領域獲得了很高的知名度。今年，我們預計關注點將集中在其他特許經營項目以及我們正在推進的項目進度上，這些項目將帶來重要的新機會。例如，在骨骼健康領域，我們的 Romosozumab 療法憑藉著積極的 3 期臨床試驗數據，其前景正逐漸明朗。

In nephrology, we expect approval later this year for Parsabiv, a therapeutic for dialysis patients and we expect pivotal data in neuroscience for our migraine antibody, AMG 334. In inflammation, we look forward later this year to establishing with the FDA that our adalimumab molecule is, indeed, biosimilar to Humira.

在腎臟病學領域，我們預計透析患者的治療藥物 Parsabiv 將於今年稍後獲得批准；我們也預計，我們的偏頭痛抗體 AMG 334 在神經科學領域將獲得關鍵數據。在發炎領域，我們期待今年稍後能與 FDA 確認，我們的阿達木單抗分子確實與 Humira 具有生物相似性。

And while I'm speaking about our biosimilars programs, I'd also remind you that we expect to submit our bevacizumab or Avastin biosimilar file to regulators this year and to have Phase 3 data for our trastuzumab or Herceptin biosimilar as well.

說到我們的生物相似藥項目，我還想提醒大家，我們預計今年將向監管機構提交貝伐單抗或阿瓦斯汀生物類似藥的文件，並公佈曲妥珠單抗或赫賽汀生物相似藥的 3 期數據。

Our transformation efforts are well underway and delivering results. This includes cost savings which David will discuss but also improved speed to market and speed in the market. And these attributes are every bit as important as cost savings as we grow our Company with new products and new territories and adapt to the changing environment for our industry.

我們的轉型工作進展順利，並已取得成效。這包括David將要討論的成本節約，以及更快的上市速度和更快的市場佔有率。隨著公司不斷發展壯大，推出新產品、開拓新市場，並適應產業環境的變化，這些特性與節省成本同樣重要。

Finally we've designed our capital allocation strategy to deliver value for shareholders through both an attractive return of capital and dividends and buybacks and vigorous investment for long-term growth. This is an exciting time in the field of biology with promising clinical opportunities and breakthroughs arising in many of our areas of interest.

最後，我們制定了資本配置策略，旨在透過具有吸引力的資本回報、股息和股票回購以及為長期成長而進行的積極投資，為股東創造價值。對於生物學領域而言，這是一個令人興奮的時代，我們許多感興趣的領域都湧現了充滿希望的臨床機會和突破。

So with a strong balance sheet and a long-term investment outlook, we will continue to look for the most promising internal and external opportunities to advance. To underscore our prior comments on this topic, our emphasis will be on focus and capital discipline as we do this.

因此，憑藉強勁的資產負債表和長期的投資前景，我們將繼續尋找最有前途的內部和外部發展機會。為了強調我們先前對此問題的評論，我們將重點放在專注和資本紀律上。

Before turning to David, let me just congratulate my colleagues around the world for the quality of their execution and a very strong start to the year. David?

在向大衛發言之前，請允許我祝賀世界各地的同事們，感謝他們出色的工作表現和今年開局的良好勢頭。大衛？

Thanks, Bob. Turning to the first-quarter financial results on page 6 of the slide deck, we are pleased with our strong performance driven by continued momentum across much of our product portfolio. Total revenues at $5.5 billion grew 10% year-over-year. Overall product sales increased 7%, reflecting continued strong performance from our growth products which more than offset the impact of competition on our legacy products, EPOGEN and NEUPOGEN.

謝謝你，鮑伯。翻到投影片第 6 頁，查看第一季財務業績，我們對公司強勁的業績感到滿意，這得益於我們大部分產品組合的持續成長勢頭。總收入達 55 億美元，年增 10%。整體產品銷售額成長了 7%，反映出我們的成長型產品持續強勁的表現，足以抵消競爭對我們傳統產品 EPOGEN 和 NEUPOGEN 的影響。

Other revenues at $288 million increased $129 million versus the first quarter of 2015. Other revenue benefited both from an upfront partner payment for a licensing transaction representing almost 40% of total other revenue for the quarter as well as higher Ibrance royalty income.

其他收入為 2.88 億美元，比 2015 年第一季增加了 1.29 億美元。其他收入受益於一筆預付給合作夥伴的許可交易款項，該款項佔本季度其他收入總額的近 40%，以及 Ibrance 特許權使用費收入的增加。

Total revenue and product sales were impacted 1% unfavorably due to foreign-exchange changes. Adjusted operating income at $2.9 billion grew 17% from prior year. Adjusted operating margin improved to 54.6% for the quarter, reflecting continued growth and progress from our transformation initiatives across all operating expense categories. As in prior years, our operating margin will likely be lower in the remaining quarters of the year driven by the timing of expenses.

受匯率變動影響，總收入和產品銷售受到1%的不利影響。經調整後的營業收入為 29 億美元，比上年增長 17%。本季調整後的營業利潤率提高至 54.6%，反映了我們在所有營運費用類別中持續成長和轉型措施的進展。與往年一樣，由於費用發生的時間安排，我們今年剩餘幾季的營業利潤率可能會降低。

In 2016 we remain on track to deliver over $400 million of gross efficiency savings from the transformation versus prior year. This enables continued investment in our pipeline and launch activities while delivering solid profitability.

2016 年，我們仍有望透過轉型實現超過 4 億美元的毛效率提升，與前一年相比。這使我們能夠繼續投資於我們的產品線和產品發布活動，同時實現穩健的獲利能力。

On an adjusted basis, cost of sales as a percent of product sales at 13.5% improved by 1.6 points, driven by manufacturing efficiencies, higher net selling price and lower royalties. Research and development expenses at $858 million were relatively unchanged in the first quarter of 2016 versus last year. SG&A expenses increased 11% on a year-over-year basis as increased commercial investments in new product launches were enabled by savings from transformation and process improvement efforts.

經調整後，銷售成本佔產品銷售額的百分比為 13.5%，改善了 1.6 個百分點，這主要得益於生產效率的提高、淨售價的提高以及特許權使用費的降低。2016 年第一季研發費用為 8.58 億美元，與去年同期相比基本維持不變。由於轉型和流程改善工作帶來的節省，使得新產品上市的商業投資得以增加，因此銷售、一般及行政費用較去年同期成長了 11%。

In total, adjusted operating expenses increased 3% year over year, including a favorable foreign exchange impact of approximately 1 percentage point. Other income and expenses were relatively flat on a year-over-year basis at $144 million in the quarter as higher interest income was offset by higher interest expense.

調整後的營運費用總額年增 3%，其中包括約 1 個百分點的有利外匯影響。本季其他收入和支出與去年同期相比基本持平，為 1.44 億美元，原因是利息收入增加被利息支出增加所抵銷。

The adjusted tax rate was 18.9% for the quarter, a 1.9 point increase versus Q1 of 2015. This increase was primarily due to the unfavorable tax impact of changes in the geographic mix of earnings and a state audit settlement in the same quarter of last year. These increases were partially offset by the adoption of Accounting Standards Update 2016-09, a new accounting standard that impacts how certain share-based compensation tax expense is recognized.

本季調整後的稅率為 18.9%，比 2015 年第一季上升了 1.9 個百分點。這一增長主要是由於去年同期收入地域構成變化帶來的不利稅收影響以及州審計和解協議所致。這些增長部分被 2016-09 號會計準則更新所抵消，這是一項新的會計準則，會影響某些股份支付稅費的確認方式。

These impacts were previously reported on the balance sheet as a change in shareholders' equity. The new rule requires these impacts to be recognized in the income statement and thus have a tax rate impact. Future tax rate impacts will depend on the movement in our stock price between when we grant share-based compensation and when it vests.

這些影響之前已在資產負債表中作為股東權益的變化進行報告。新規要求在損益表中確認這些影響，因此會對稅率產生影響。未來的稅率影響將取決於我們授予股票選擇權補償到選擇權歸屬期間股價的走勢。

The Q1 benefit of this change adds approximately $0.09 to our adjusted earnings-per-share. Adjusted net income increased 15% and adjusted earnings per share increased 17% year over year.

這項變化在第一季帶來的收益約為調整後每股收益增加 0.09 美元。經調整後的淨利年增 15%，經調整後的每股盈餘較去年同期成長 17%。

Turning next to cash flow and the balance sheet on page 7. Free cash flow was $1.8 billion, an increase of $400 million over last year. We deployed $0.7 billion to repurchase 4.6 million shares in the quarter at an average price of $147 per share. And we are on track to achieve total share repurchase for this year in the range of $2 billion to $3 billion. Additionally our first-quarter dividend increased to $1 per share, an increase of 27% of last year.

接下來請看第 7 頁的現金流量表和資產負債表。自由現金流為 18 億美元，比去年增加了 4 億美元。本季我們投入 7 億美元回購了 460 萬股股票，平均價格為每股 147 美元。我們預計將實現今年股票回購總額在 20 億至 30 億美元之間的目標。此外，我們第一季的股息增加到每股 1 美元，比去年增長了 27%。

At the end of the first quarter, we had $4.2 billion remaining on our Board-authorized share buyback program and are on track to deliver on our capital allocation commitments to shareholders. Cash and investments totaled $34.7 billion, an increase of $7.6 billion from last year's first-quarter level. This increase reflects strong net cash flow and our first-quarter debt issuance of $2.9 billion of which approximately $2 billion will be used to repay debt maturities over the balance of this year.

第一季末，我們經董事會批准的股票回購計畫中還剩餘 42 億美元，我們正按計畫履行對股東的資本配置承諾。現金及投資總額為 347 億美元，比去年第一季增加了 76 億美元。這一成長反映了強勁的淨現金流，以及我們第一季發行的 29 億美元債券，其中約 20 億美元將用於償還今年剩餘時間內到期的債務。

Our debt balance stands at $34.3 billion as of March 31 of this year. Our total debt portfolio has a weighted average interest rate of 3.7% and an average maturity of 11 years.

截至今年3月31日，我們的債務餘額為343億美元。我們的總債務組合的加權平均利率為 3.7%，平均到期期限為 11 年。

Turning to the outlook for the business for the remainder of 2016 on page 8, we remain on track with our plans to continue investing to grow the business while transforming to a more agile and efficient operating model. Today we are increasing our 2016 guidance which reflects solid Q1 performance from revenue and expense as well as a revised tax outlook.

在第 8 頁，我們將展望 2016 年剩餘時間的業務前景，我們將繼續按計劃投資以發展業務，同時轉型為更靈活、更有效率的營運模式。今天，我們提高了 2016 年的業績預期，這反映了第一季收入和支出的穩健表現以及修訂後的稅收前景。

With this background, our 2016 revenue guidance is now $22.2 to $22.6 billion versus prior guidance of $22.0 billion to $22.5 billion. And our adjusted earnings-per-share guidance is now $10.85 to $11.20 a share versus prior guidance of $10.60 to $11. In addition, we now expect our adjusted tax rate to be 19% to 20%, including the impact of the previously mentioned Accounting Standards Update, versus prior guidance of 19.5% to 20.5%. Finally we expect to invest capital expenditures of approximately $700 million this year.

基於此背景，我們 2016 年的營收預期為 222 億美元至 226 億美元，而先前的預期為 220 億美元至 225 億美元。我們調整後的每股盈餘預期為每股 10.85 美元至 11.20 美元，而先前的預期為每股 10.60 美元至 11 美元。此外，我們現在預計調整後的稅率為 19% 至 20%，其中包括先前提到的會計準則更新的影響，而先前的指導值為 19.5% 至 20.5%。最後，我們預計今年將投資約7億美元用於資本支出。

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

財務更新到此結束。現在我將把電話轉給托尼。

Thank you, David, and good afternoon folks. You'll find a summary of our sales performance for the first quarter on slide 10. As Bob said, we had a great start with global product sales in the first quarter growing by 7% year over year. Our US business delivered 9% year-over-year growth and sales growth in our international business was negatively impacted by 5 percentage points due to foreign-exchange. Excluding the foreign-exchange impact, our international business was up 7% year over year.

謝謝你，大衛，各位下午好。您可以在第 10 頁找到我們第一季的銷售業績總結。正如鮑伯所說，我們開局良好，第一季全球產品銷售額年增 7%。我們的美國業務實現了 9% 的年成長，而由於匯率波動，我們的國際業務銷售成長受到了 5 個百分點的負面影響。剔除匯率影響，我們的國際業務年增7%。

I will structure my comments in three categories today. Performance in our growth products, how we are managing the lifecycle of our mature brands and conclude with an update on the performance of our newly launched products. First our six growth products: Prolia, XGEVA, Vectibix, Nplate, Sensipar and Enbrel aggregated nearly $3 billion in sales or over 50% of the first-quarter sales, growing 20% year-over-year. Sustaining their growth continues to be priority for us.

今天我將分三類來闡述我的觀點。我們將介紹成長型產品的表現，如何管理成熟品牌的生命週期，並最後更新新推出的產品的表現。首先，我們的六款成長型產品：Prolia、XGEVA、Vectibix、Nplate、Sensipar 和 Enbrel 的總銷售額接近 30 億美元，佔第一季銷售額的 50% 以上，年增 20%。維持他們的成長仍然是我們的首要任務。

Let me start with Prolia and XGEVA which are now annualizing at approximately $3 billion per year. Prolia grew significantly at 29% year-over-year. Continued share gains drove growth in both the US and Europe, with over 25% year-over-year unit demand growth in both regions. We saw the typical seasonality in the first quarter.

讓我先從Prolia和XGEVA說起，它們目前的年收入約為30億美元。Prolia 年增 29%，增幅顯著。市場佔有率的持續成長推動了美國和歐洲市場的成長，這兩個地區的年均單位需求成長均超過 25%。第一季我們看到了典型的季節性波動。

In the US, our direct-to-consumer promotional efforts continue to drive increasing levels of new-patient adoption and we are sustaining repeat injection rates of over 65%. We expect continued growth from Prolia to come for years.

在美國，我們面向消費者的直接推廣活動持續推動新患者數量的成長，並且我們保持超過 65% 的重複注射率。我們預計Prolia未來幾年將持續成長。

XGEVA grew 11% year over year. Unit share increased about 3 percentage points over last year in both the US and Europe. The first quarter was positively impacted by increased levels of purchasing by some large end customers in the US which we expect to burn off in the next quarter. We continue to focus on XGEVA's superior clinical profile versus the competition and look forward to potential new indications which will drive sustained long - growth.

XGEVA較去年同期成長11%。美國和歐洲的市佔率均比去年增長了約 3 個百分點。第一季受到美國一些大型終端客戶採購量增加的正面影響，我們預計這些採購量將在下一季消耗掉。我們將繼續關注 XGEVA 相對於競爭對手的卓越臨床表現，並期待潛在的新適應症將推動持續的長期成長。

Turning to Vectibix and Nplate, unit demand growth drove double-digit gains year-over-year across both products. For Vectibix, we continue to make solid inroads into earlier lines of therapy in both the US and Europe.

再來看 Vectibix 和 Nplate，單位需求成長推動了這兩個產品年增兩位數。對於 Vectibix，我們繼續在美國和歐洲的早期治療領域取得穩步進展。

Sensipar grew 10% year over year driven by net selling price as well as unit growth in the US and Europe. With sales annualizing around $1.5 billion, Sensipar remains a growth driver. We look forward to adding Parsabiv as another treatment option for patients with secondary hyperparathyroidism. Our regulation filings for Parsabiv are currently under review in both the US and Europe.

受淨售價以及美國和歐洲銷量成長的推動，Sensipar 年成長 10%。Sensipar 的年銷售額約為 15 億美元，仍然是成長的驅動力。我們期待帕薩比夫（Parsabiv）作為繼發性副甲狀腺功能亢進症患者的另一個治療選擇。我們提交給 Parsabiv 的監管文件目前正在美國和歐洲接受審查。

Let me now turn to Enbrel. Enbrel grew 24% year-on-year due to changes in net selling price and inventory, which was partially offset by competition. As a reminder, net selling price change comprised several components, including list price increases as well as rebates we provide to payers and the impact of formulary decisions.

現在讓我來談談恩利（Enbrel）。由於淨售價和庫存的變化，恩利（Enbrel）同比增長 24%，但部分增長被競爭所抵消。提醒一下，淨售價變化包括幾個組成部分，包括標價上漲、我們向付款方提供的回扣以及處方集決策的影響。

In the third quarter 2016, inventory was at a normal level. The year-over-year inventory growth is as a result of prior-year dynamics. The climbs in inventory levels in the first quarter last year make for an approximately $100 million favorable comparison this quarter. As we think about the second quarter this year, we expect to see a reverse effect of a similar magnitude. In other words, the significant inventory build in the second quarter of 2015 will create an unfavorable comparison assuming inventory levels remain normal next quarter.

2016年第三季度，庫存處於正常水準。庫存同比增長是由於上年同期情況所致。去年第一季庫存水準的攀升，使得本季的年增幅約為 1 億美元。展望今年第二季度，我們預計會出現類似程度的相反影響。換句話說，2015 年第二季的大量庫存累積將導致不利的比較結果，假設下個季度的庫存水準保持正常。

Turning to underlying performance for Enbrel, we saw 14% year-on- year growth in the rheumatology segment for the first quarter and Enbrel held quarter-over-quarter value share at 28%.

從 Enbrel 的實際業績來看，第一季風濕病業務年增 14%，Enbrel 的季度環比市佔率為 28%。

In dermatology, competition from new entrants, primarily non-biologics, helped drive year-on-year segment growth of 29%. Enbrel's share in dermatology declined 1 percentage point quarter over quarter to 21%. If you'll recall, rheumatology comprises about 80% of Enbrel sales. Given Enbrel's exclusivity through 2029, it remains a critical growth driver that we are continuing to invest behind.

在皮膚病學領域，來自新進業者（主要是非生物製劑）的競爭推動了該領域每年 29% 的成長。Enbrel 在皮膚科領域的市佔率較上季下降 1 個百分點至 21%。你可能還記得，風濕病領域約佔恩利銷售額的 80%。鑑於 Enbrel 的獨家銷售權將持續到 2029 年，它仍然是一個重要的成長驅動力，我們將繼續加強對其的投資。

Let me now turn to how we're managing the lifecycle of our mature brands, starting with our ESA products. Aranesp sales increased 11% year over year, driven by 15% unit growth. In the US we are successfully transitioning our medium size and independent dialysis centers from EPOGEN to Aranesp. Aranesp now represents over 70% of ESAshare of these providers.

現在讓我談談我們是如何管理成熟品牌的生命週期的，首先從我們的 ESA 產品說起。Aranesp 的銷售額年增 11%，其中銷量成長 15%。在美國，我們正在成功地將我們的中型和獨立透析中心從 EPOGEN 過渡到 Aranesp。Aranesp 目前佔 ESAshare 這些供應商的 70% 以上。

International sales were negatively impacted by pricing pressures and foreign exchange rates. EPOGEN declined 44% year-over-year. About one-third of this decline is a shift from EPOGEN to Aranesp in the dialysis setting I mentioned above. Most of the reigning decline comes from the shift from Amgen ESA to Mircera at Fresenius.

國際銷售受到價格壓力和匯率波動的負面影響。EPOGEN年減44%。其中約三分之一的下降是由於我上面提到的透析環境中從 EPOGEN 轉向 Aranesp 所致。目前大部分的下滑是由於費森尤斯公司將安進的 ESA 產品替換為 Mircera 產品所致。

We understand that Fresenius, which represents about one-third of the US dialysis business has converted over 70% of their patients to Mircera. If you remember, we have a contract with DaVita which represents another one-third of the dialysis business through 2018 to purchase at least 90% of their ESAs from Amgen. I'd like to point that we also do not expect biosimilar competition to EPOGEN in 2016.

我們了解到，費森尤斯公司佔據了美國透析業務約三分之一的份額，該公司已將其超過 70% 的患者轉而使用 Mircera 透析系統。如果您還記得，我們​​與 DaVita 簽訂了一份合同，該合約涵蓋了 2018 年透析業務的三分之一，我們將從安進公司購買至少 90% 的 ESA。我想指出的是，我們也不認為 2016 年會有生物相似藥與 EPOGEN 競爭。

NEUPOGEN declined 13% year over year and 19% quarter over quarter with the competitive landscape playing out as we generally expected. NEUPOGEN exited the quarter with a 64% share of the short-acting segment which now consists of Zarxio, GRANIX and Leukine.

紐寶金年減 13%，季減 19%，競爭格局的發展正如我們預期的。紐普根本季末在短效藥物市場佔有 64% 的份額，目前包括 Zarxio、GRANIX 和 Leukine。

As we said before, we'll continue to compete account by account as competition intensifies. We continue to emphasize the value of NEUPOGEN, built on its track record of safety, efficacy and reliable supply.

正如我們之前所說，隨著競爭加劇，我們將繼續逐一客戶競爭。我們繼續強調NEUPOGEN的價值，這建立在其安全、有效和可靠供應的良好記錄之上。

Neulasta grew 4% during the quarter. Unit growth of 3% included purchases by some large US end customers which we expect to burn off next quarter.

Neulasta 本季成長了 4%。3%的銷售成長包括一些美國大型終端客戶的採購，我們預計這些採購將在下個季度消化掉。

Let me now turn to our launches, beginning with the Neulasta Onpro kit. The Neulasta Onpro kit has been an extremely successful launch achieving about one-third share of Neulasta units in the first quarter and approaching $1 billion in cumulative sales in the 12 months since launch. Patients undergoing myelosuppressive chemotherapy regimens are at-risk of serious infections. One of the biggest challenges physicians face in preventing these infections is patient compliance.

現在讓我來介紹一下我們的新品發布，首先是 Neulasta Onpro 套件。Neulasta Onpro 套件的推出非常成功，在第一季就佔據了 Neulasta 設備約三分之一的市場份額，自推出以來的 12 個月累計銷售額接近 10 億美元。接受骨髓抑制性化療方案的患者有發生嚴重感染的風險。醫生在預防這些感染方面面臨的最大挑戰之一是患者的依從性。

Both ensuring patients get the Neulasta injection after each course of chemo and at the right time, 24 hours after chemo. These are critical steps in order to ensure maximum benefit of Neulasta. With the Neulasta Onpro kit, we're able to address this important unmet need. This innovation also provides meaningful differentiation versus the traditional pre-filled syringe and potential future competitors.

確保患者在每次化療後 24 小時內接受 Neulasta 注射。這些都是確保Neulasta發揮最大療效的關鍵步驟。透過 Neulasta Onpro 套件，我們能夠滿足這重要的未被滿足的需求。這項創新也為與傳統預充式註射器和未來潛在的競爭對手之間提供了有意義的差異化。

We also see the compliance rates improving with the use of Neulasta Onpro based on patient level data. This is a great example of our strategy to identify and develop innovative delivery systems to improve the patient experience. By all measures, this is a highly successful launch and the value it brings to patients and the healthcare system is translating into strong performance.

根據患者層面的數據，我們也看到，使用 Neulasta Onpro 的依從性有所提高。這是我們透過識別和開發創新交付系統來改善患者體驗的策略的絕佳例證。無論從哪個角度來看，這都是一次非常成功的發布，它為患者和醫療保健系統帶來的價值正在轉化為強勁的業績。

We remain focused on increasing adoption to benefit more patients. Kyprolis grew 20% year over year on a sequential basis. US unit growth was offset by unfavorable changes to inventory and to net selling price. The addition of ENDEAVOR data, which demonstrated superiority versus Velcade, to the US label in January further solidifies Kyprolis's profile as a backbone of multiple myeloma therapy. We expect sales to continue to grow as we treat more second-line patients and they stay on therapy longer to achieve deeper and more durable responses.

我們將繼續致力於提高普及率，以使更多患者受益。Kyprolis 的表現季增了 20%。美國銷售成長被庫存和淨售價的不利變化所抵消。1 月份，ENDEAVOR 研究數據被添加到美國藥品標籤中，證明 Kyprolis 優於 Velcade，進一步鞏固了 Kyprolis 作為多發性骨髓瘤治療支柱的地位。我們預計，隨著我們治療更多二線患者，並且他們接受治療的時間更長，從而獲得更深層、更持久的療效，銷售額將繼續增長。

In markets outside the US, we're making good progress with our launches. Initial results have been very positive as we bring this important therapy to these patients. Blincyto continues to increase patient penetration in the US and launches are underway across Europe as reimbursement is secured. Sean will discuss developments of our bi-specific antibody platform in a moment.

在美國以外的市場，我們的產品上市進展順利。我們將這項重要的療法帶給這些患者，初步結果非常正面。Blincyto 在美國的病患滲透率持續提高，隨著報銷的落實，該產品正在歐洲各地陸續上市。Sean 稍後將討論我們雙特異性抗體平台的發展。

IMLYGIC, our Oncolytic immunotherapy for metastatic melanoma is currently indicated as monotherapy in the US and Europe and is playing an important role in addressing the needs for this small patient population. We believe that true potential for IMLYGIC lies in combination with other immunotherapies across different tumor types.

IMLYGIC 是我們用於治療轉移性黑色素瘤的溶瘤免疫療法，目前在美國和歐洲被批准作為單藥療法，並在滿足這一小部分患者群體的需求方面發揮著重要作用。我們相信，IMLYGIC 的真正潛力在於與其他免疫療法聯合用於治療不同類型的腫瘤。

Turning now to Repatha, which I continue to believe is one of our largest opportunities. I'm pleased with our competitiveness to date. Our robust clinical development program clearly demonstrated Repatha's ability to deliver intensive and predictable LDL-C reduction.

現在來說說Repatha，我仍然認為這是我們最大的機會之一。我對我們迄今為止的競爭力感到滿意。我們強大的臨床開發計劃清楚地證明了 Repatha 能夠實現強效且可預測的 LDL-C 降低。

This message continues to resonate well with physicians and coupled with strong execution in the marketplace we continue to lead prescribing in the US as seen in the IMS data. In Europe reimbursement are negotiations on track and we are in early launch in several countries, including Germany, Spain, the Netherlands and Scandinavia.

這項訊息持續引起醫生的共鳴，再加上我們在市場上的強有力執行，正如IMS數據所示，我們繼續在美國的處方量方面處於領先地位。在歐洲，報銷談判進展順利，我們在包括德國、西班牙、荷蘭和斯堪的納維亞半島在內的幾個國家已經開始早期推廣。

In Japan we have now received pricing approval and launch activities with our partner Astellas are well underway.

在日本，我們已經獲得了定價批准，與合作夥伴安斯泰來製藥的上市活動正在順利進行中。

Before handing over to Sean, I thought I would provide some color on the Repatha launch. In my personal experience, I have seen a number of examples of successful, high-value, slow-ramping products that share a few common traits with Repatha.

在把麥克風交給肖恩之前，我想先介紹一下Repatha的上市情況。就我個人經驗而言，我見過許多成功的、高價值的、緩慢成長的產品，它們與 Repatha 有一些共同的特徵。

First, these products often contribute to changes in treatment paradigms such as new mechanism of action and new routes of administration. In the case of Repatha, inhibition of PCSK9 is a novel mechanism and it is the first injectable biologic addressing chronic cardiovascular disease. I'm excited about the prospect of launching the Repatha monthly dosing option later this year, reducing the number of required injections and creating another potential point of differentiation from the competition.

首先，這些產品往往會改變治療模式，例如產生新的機制和新的給藥途徑。以 Repatha 為例，PCSK9 抑制是一種新的機制，它是第一個用於治療慢性心血管疾病的注射型生物製劑。我對今年稍後推出 Repatha 每月一次的給藥方案的前景感到興奮，這將減少所需的注射次數，並創造另一個與競爭對手不同的潛在優勢。

Second, these products often have significant development programs that improve the product profile, expand their patient pools or extended duration of therapy over time. With Repatha, our GAUSS-3 study in statin intolerant patients was very well received by physicians at the recent American College of Cardiology meeting.

其次，這些產品通常都有重要的研發計劃，可以改善產品特性、擴大患者群體或延長治療時間。在最近舉行的美國心臟病學會會議上，我們針對不耐受他汀類藥物的患者進行的 GAUSS-3 研究，以及 Repatha 的研究，都受到了醫生們的熱烈歡迎。

Our coronary imaging study will read out later this year was designed to demonstrate that Repatha reduces patients' plaque burden. And most significantly, of course, we expect the readout of a large 27,500 patient outcomes trial later this year, which we expect will establish a clear benefit in cardiovascular outcomes based on Repatha's profound effect on lowering LDL cholesterol.

我們今年稍後將發表的冠狀動脈成像研究旨在證明 Repatha 可以減少患者的斑塊負荷。當然，最重要的是，我們預計今年稍後將公佈一項涉及 27,500 名患者的大型療效試驗結果，我們預計今年稍後將公佈一項涉及 27,500 名患者的大型療效試驗結果，我們預計該試驗將基於 Repatha 對降低 LDL 膽固醇的顯著作用，確立其在心血管療效方面的明顯益處。

Lastly access and reimbursement hurdles, while intense, should be overcome with a demonstration of superior clinical benefits versus the current standard of care. We expect to establish this with Repatha through the outcome study I just mentioned. You might have seen this dynamic successfully play out for the Factor Xa's as they displaced warfarin.

最後，雖然准入和報銷方面的障礙很重，但只要證明其臨床療效優於目前的標準療法，這些障礙就應該被克服。我們希望透過我剛才提到的成果研究，與 Repatha 達成共識。你可能已經看到這種動態在 Xa 因子取代華法林的過程中得到了成功體現。

I am unwavering in my commitment and in the belief of Repatha. We will continue to work with payers to improve access to Repatha for appropriate patients and expect its strong value proposition to benefit patients with ASCVD who are at risk of heart attack or stroke.

我對瑞百莎的承諾和信念堅定不移。我們將繼續與支付方合作，改善合適的患者獲得瑞百安（Repatha）的機會，並期望其強大的價值主張能夠使有心臟病發作或中風風險的 ASCVD 患者受益。

In closing, I'm pleased with our execution this quarter and our strong start to the year. We've maintained focus on our growth brands while defending our mature portfolio and launching new products. We recognize that our launch products are an important long-term value driver and are working relentlessly to make them a success.

最後，我對本季的執行情況以及今年的良好開局感到滿意。我們始終專注於發展成長型品牌，同時捍衛成熟產品組合併推出新產品。我們認識到，我們的首發產品是重要的長期價值驅動因素，我們正在不懈地努力，力求使它們取得成功。

Let me close by recognizing that none of this would have been possible without the dedication of our staff and thanking them for their commitment to delivering to patients. Let me now pass to Sean.

最後，我要感謝所有員工的奉獻精神，正是他們的努力使得這一切成為可能，感謝他們為病人提供優質服務。現在把麥克風交給肖恩。

Thanks. Good afternoon. We've made a lot of exciting progress in Q1 as we continue to advance our pipeline of innovative programs. I'll begin my remarks with our cardiovascular franchise starting with Repatha. Statin-associated muscle symptoms represent a major unresolved challenge to the treatment in patients with cardiovascular disease and often result in the use of therapies that provide less LDL-cholesterol reduction than desired. In our recently completed Phase 3 study, GAUSS-3, we evaluated Repatha and ezetimibe in a group of patients whose statin intolerance was verified by rigorous blinded statin re-challenge where only those patients that experienced muscle-related side effects on statin, but not on placebo, were studied.

謝謝。午安.第一季度，我們取得了許多令人振奮的進展，我們將繼續推動創新專案的研發。我將首先介紹我們的心血管產品系列，從瑞百安（Repatha）開始。他汀類藥物引起的肌肉症狀是心血管疾病患者治療中尚未解決的主要挑戰，並且常常導致使用的療法無法達到預期的 LDL 膽固醇降低效果。在我們最近完成的 3 期研究 GAUSS-3 中，我們評估了 Repatha 和依澤替米貝在一組患者中的療效，這些患者對他汀類藥物不耐受，並通過嚴格的雙盲他汀類藥物再挑戰試驗證實了這一點。該試驗僅研究了服用他汀類藥物後出現肌肉相關副作用，但服用安慰劑後未出現此類副作用的患者。

As presented at the ACC meeting and simultaneously published in the Journal of American Medical Association, the study demonstrated that Repatha resulted in a significantly greater reduction in LDL cholesterol after 24 weeks as compared to ezetimibe with low levels of muscle-related adverse events. We believe this is an important result for those high-risk patients that are unable to effectively manage their LDL-cholesterol due to muscle symptoms from statins.

該研究在 ACC 會議上發表，並同時發表在《美國醫學會雜誌》上，結果表明，與依折麥布相比，Repatha 在 24 週後能顯著降低 LDL 膽固醇，且肌肉相關不良事件發生率較低。我們認為，對於那些因服用他汀類藥物引起的肌肉症狀而無法有效控制低密度脂蛋白膽固醇的高風險患者來說，這是一個重要的結果。

Looking ahead as Tony mentioned, we continue to look forward to the results of our coronary imaging study and cardiovascular outcome studies in the second half of this year. We also continue to work closely with regulators on their reviews of our Repatha monthly dosing option.

展望未來，正如托尼所提到的那樣，我們繼續期待今年下半年冠狀動脈成像研究和心血管結果研究的結果。我們也將繼續與監管機構密切合作，共同檢視我們 Repatha 的每月給藥方案。

Feedback from cardiologists on our innovative myosin activator Omecamtiv mecarbil, has been consistent that we have a very compelling mechanism of action in the Phase 2 data set. We are currently working with our partners at Cytokinetics and Servier, as well as global regulators to define a potential path to Phase 3 outcome studies.

心臟科醫師對我們創新的肌球蛋白活化劑 Omecamtiv mecarbil 的回饋一直一致，認為我們在 2 期資料集中具有非常令人信服的作用機制。我們目前正與 Cytokinetics 和 Servier 的合作夥伴以及全球監管機構合作，以確定進行 3 期結果研究的潛在途徑。

Turning to oncology, our Phase 3 open label study evaluating BLINCYTO versus standard of care in patients with Philadelphia chromosome negative relapsed or refractory ALL was stopped at a pre-specified interim analysis after successfully achieving the primary endpoint of overall survival. This is a first for an immunotherapy in this population and we look forward to discussions with regulators as we seek convergence to full approval.

轉向腫瘤學方面，我們針對費城染色體陰性復發或難治性 ALL 患者開展的 3 期開放標籤研究評估了 BLINCYTO 與標準治療的療效，該研究在預先設定的中期分析中成功達到了總生存期的主要終點後終止。這是針對該族群的首例免疫療法，我們期待與監管機構進行討論，以期獲得全面批准。

In Q1, we also filed an sBLA for BLINCYTO in the US to include new data supporting the treatment of pediatric and adolescent patients with ALL. We feel BLINCYTO could be an important treatment option for younger patients, potentially avoiding the complications later in life such as secondary malignancies that can arise with the use of cytotoxic chemotherapies.

第一季度，我們也在美國提交了 BLINCYTO 的補充生物製品許可申請 (sBLA)，以納入支持治療患有 ALL 的兒童和青少年患者的新數據。我們認為 BLINCYTO 可能成為年輕患者的重要治療選擇，有可能避免日後因使用細胞毒性化療而引起的併發症，例如繼發性惡性腫瘤。

We are advancing our bispecific T-cell engager or BiTE platform including AMG 330 which continues to enroll patients in its Phase 1 dose escalation study. Recall that AMG 330 is our CD33 BiTE for Acute Myelogenous Leukemia or AML. AML remains an area of profound unmet medical need. Despite adult AML being about four times as prevalent as adult ALL and with a very poor prognosis, there have been no significant advances approved in the last 20 years.

我們正在推進我們的雙特異性 T 細胞銜接器或 BiTE 平台，包括 AMG 330，該平台正在繼續招募患者參與其 1 期劑量遞增研究。請記住，AMG 330 是我們用於治療急性骨髓性白血病 (AML) 的 CD33 BiTE。急性髓性白血病（AML）仍然是一個醫療需求遠未被滿足的領域。儘管成人急性骨髓性白血病 (AML) 的發生率約為成人急性淋巴性白血病 (ALL) 的四倍，且預後極差，但在過去 20 年中，尚未有任何重大進展獲得批准。

Staying with our immuno oncology platforms, we recently initiated enrollment in the Phase 3 portion of our melanoma study of IMLYGIC in combination with KEYTRUDA, Merck's PD-1 inhibitor. And we look forward to presenting the results from the Phase 1B portion of this study at the upcoming ASCO meeting.

繼續推進我們的免疫腫瘤學平台，我們最近啟動了IMLYGIC聯合默克公司PD-1抑制劑KEYTRUDA治療黑色素瘤的3期研究的患者招募工作。我們期待在即將召開的 ASCO 會議上公佈這項研究的 1B 期部分的結果。

We also recently presented some encouraging first-in-human data at the American Association for Cancer Research annual meeting from one of our early stage immuno-oncology programs, AMG 820. This is our antibody against colony stimulating factor 1 receptor, also known as c-fms, which simulates the activation of tumor associated macrophages.

最近，我們也在美國癌症研究協會年會上展示了我們早期免疫腫瘤學計畫 AMG 820 的一些令人鼓舞的首次人體試驗數據。這是我們針對集落刺激因子 1 受體（也稱為 c-fms）的抗體，它可以模擬腫瘤相關巨噬細胞的活化。

There is great interest in the role that tumor-associated macrophages play in tumor immunosuppression and we're hoping to lead this field with AMG 820, which is now enrolling patients in a Phase 1-2 study in combination with KEYTRUDA in advanced solid tumors. Before I leave oncology, I would note we continue to have productive interactions with regulators in Europe on the Kyprolis ENDEAVOR submission.

人們對腫瘤相關巨噬細胞在腫瘤免疫抑制中的作用非常感興趣，我們希望憑藉 AMG 820 引領這一領域，AMG 820 目前正在進行一項 1-2 期研究，與 KEYTRUDA 聯合用於治療晚期實體瘤。在我離開腫瘤科之前，我想指出，我們與歐洲監管機構就 Kyprolis ENDEAVOR 申請的進展仍在持續。

And I'm also pleased to announce that our Phase 3 study of XGEVA versus zoledronic acid for the prevention of skeletal-related events in patients with newly diagnosed multiple myeloma has completed its enrollment. This is an event-driven study and based on the current event rate we estimate the data will be available in the second half of this year.

同時，我很高興地宣布，我們針對新診斷的多發性骨髓瘤患者進行的 XGEVA 與唑來膦酸預防骨骼相關事件的 3 期研究已完成入組。這是一項以事件為導向的研究，根據目前的事件發生率，我們估計數據將在今年下半年公佈。

In bone health we were pleased to report, along with our partners at UCB, the positive results from two Phase 3 Romosozumab studies in Q1. Most importantly, our placebo-controlled pivotal fracture study met both of its primary vertebral fracture end points as well as the important secondary endpoint of clinical fracture reduction. This latter endpoint consists of symptomatic vertebral fractures plus non-vertebral fractures, an endpoint increasingly recognized by physicians, payers and regulators as these are the symptomatic fractures that can be life altering.

在骨骼健康方面，我們很高興地與 UCB 的合作夥伴一起報告了第一季兩項 Romosozumab 3 期研究的正面結果。最重要的是，我們的安慰劑對照關鍵性骨折研究達到了其兩個主要椎體骨折終點以及重要的次要終點——臨床骨折減少。後一個終點包括有症狀的椎體骨折和非椎體骨折，這一終點越來越受到醫生、支付方和監管機構的認可，因為這些是有症狀的骨折可能會改變生活。

Our Phase 3 study of Romosozumab in men with osteoporosis also successfully completed in Q1 with Romosozumab treatment resulting in significant gains in bone mineral density versus placebo. We look forward to our pre-BLA meeting with FDA as we pull together our initial filing package in the US. We also await the results from the event-driven fracture study evaluating Romosozumab in comparison to alendronate which we expect to see in 2017 and will be part of our European filing.

我們針對骨質疏鬆症男性患者的 Romosozumab 3 期研究也在第一季成功完成，Romosozumab 治療與安慰劑相比，顯著提高了骨礦物質密度。我們期待與FDA召開BLA申請前會議，以便整理我們在美國提交的初步申請資料。我們也期待評估羅莫索單抗與阿崙膦酸鈉療效的事件驅動型骨折研究的結果，我們預計將在 2017 年看到該結果，並將成為我們向歐洲提交申請的一部分。

Switching to neuroscience, we had the opportunity to present the 52-week data from our Phase 2 episodic migraine study with our CGRP receptor antibody AMG 334 at the American Academy of Neurology meeting earlier this month.

轉而關注神經科學領域，我們有機會在本月初的美國神經病學學會會議上展示了我們 CGRP 受體抗體 AMG 334 治療發作性偏頭痛的 2 期研究的 52 週數據。

After one year of treatment with the 70 milligram monthly dosing regimen, more than 60% of patients experienced at least a 50% reduction in their monthly migraine days and about 20% of patients had no migraine days in month 12. These are patients that were having on the order of eight migraine days per month so this is quite a clinically meaningful result.

經過一年每月 70 毫克的劑量治療方案後，超過 60% 的患者每月偏頭痛天數至少減少了 50%，約 20% 的患者在第 12 個月沒有偏頭痛發作。這些患者平均每月有八天左右的偏頭痛，因此這是一個具有相當臨床意義的結果。

We believe the efficacy, tolerability and administration profile of AMG 334 could be an attractive option for migraine patients considering the lack of well-tolerated prophylactic options currently available. We are rapidly advancing this program through the clinic with our partners at Novartis.

考慮到目前缺乏耐受性良好的預防性治療方案，我們認為 AMG 334 的療效、耐受性和給藥特性可能對偏頭痛患者來說是一個有吸引力的選擇。我們正與諾華公司的合作夥伴一起，快速推進該計畫的臨床試驗。

We now expect to have the results from our Phase 2B chronic migraine study midyear and we intend to use this study to potentially gain an indication in chronic migraine in our initial BLA filing. We've also completed enrollment in both of our Phase 3 episodic migraine studies and expect the results from both of these in the second half of this year. Also in migraine we believe that AMG 301, our PAC1 receptor antibody could complement AMG 334 and we continue to progress this asset through Phase 1.

我們現在預計將在年中獲得 2B 期慢性偏頭痛研究的結果，我們打算利用這項研究，在我們的首次 BLA 申請中獲得慢性偏頭痛的適應症。我們已經完成了兩項 3 期發作性偏頭痛研究的受試者招募工作，預計今年下半年將獲得這兩項研究的結果。此外，我們認為，在偏頭痛方面，我們的 PAC1 受體抗體 AMG 301 可以與 AMG 334 互補，我們將繼續推進該資產進入 1 期臨床試驗。

In other regulatory activities, we continue to work with global regulators on their review of Parsabiv, our novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism in patients on hemodialysis. FDA has also accepted our sBLA for the expanded use of Enbrel to treat pediatric patients with chronic severe Plaque Psoriasis.

在其他監管活動中，我們繼續與全球監管機構合作，審查我們的新型靜脈注射擬鈣劑 Parsabiv，該藥物用於治療接受血液透析治療的患者的繼發性副甲狀腺功能亢進症。FDA 也已接受我們關於擴大 Enbrel 用於治療患有慢性重度斑塊狀乾癬的兒科患者的補充生物製品許可申請 (sBLA)。

Finally with several pivotal data sets and regulatory decisions ahead of us, we have a lot to look forward to this year and I'd like to take a moment to thank all of my colleagues at Amgen for their unwavering focus on delivering innovative new medicines for patients in need. Bob?

最後，隨著幾項關鍵數據集和監管決定即將出台，我們今年有很多值得期待的事情。我想藉此機會感謝安進的所有同事，感謝他們始終如一地致力於為有需要的患者提供創新藥物。鮑伯？

Okay. Thank you, Sean. Let's turn it over now to questions. And, Arvind, why don't you remind our callers of the procedure.

好的。謝謝你，肖恩。現在進入提問環節。阿文德，你為什麼不提醒一下我們的來電者相關流程呢？

Yes, Jake, if you go ahead and open it up for Q&A and review the procedure for asking questions, please.

是的，傑克，如果你願意的話，請開放問答環節，並講解一下提問流程。

(Operator instructions)

（操作說明）

Matthew Harrison, Morgan Stanley.

馬修·哈里森，摩根士丹利。

Just a couple for Tony. You mentioned the end customer purchases for Neulasta and XGEVA. Can you tell how large they were? And then second maybe if you could expand around your comments for Repatha. I think it's our understanding that 70%, 80% scripts are abandoned at the pharmacy.

就給托尼兩份。您提到了 Neulasta 和 XGEVA 的終端客戶採購情況。你能看出它們有多大嗎？其次，如果您能詳細闡述您對 Repatha 的評論就更好了。據我們了解，有 70% 到 80% 的處方藥被藥局遺棄。

What's your view on what needs to change to lower that rate? And how should we think about the change that outcomes data, if positive, could have there and is there a rate, a hazard ratio, for example, in the outcomes data that you think would cause a significant shift in some of those utilization management criteria?

您認為需要做出哪些改變才能降低這個比率？那麼，我們應該如何看待結果數據（如果結果是正面）可能帶來的改變？例如，結果資料中是否存在某種比率或風險比，您認為它會導致某些利用管理標準發生重大變化？

Okay. So let me try and go through this. On the large end customer user purchases for XGEVA and Neulasta, in the range of 30 million to 50 million, so not a large amount but they will clearly burn off during the second quarter.

好的。那我來試著解釋一下。XGEVA 和 Neulasta 的大宗終端客戶用戶採購額在 3,000 萬到 5,000 萬之間，雖然金額不大，但顯然會在第二季消耗掉。

When I look at Repatha, it is about a 77% rejection rate, not abandonment, that's happening at pharmacy. So a lot of the prescriptions are being denied because they don't quite fit the prior op process which has been required. Talking to cardiologists, it's clear they are extremely frustrated at the moment because the patients they are sending in are appropriate patients who have not being properly managed on a maximally-tolerated statin at the moment.

我查看 Repatha 的案例，發現藥局裡發生的是大約 77% 的拒收率，而不是放棄率。因此，許多處方都被拒絕了，因為它們不太符合先前要求的手術流程。與心臟科醫生交談後，很明顯他們目前感到非常沮喪，因為他們送來的病人都是合適的病人，但目前並沒有接受最大耐受劑量的他汀類藥物治療。

We're spending quite a bit of time with payers at the moment and helping them see what I would imagine is the unintended consequences of a rather onerous paper-based prior authorization system which is resulting in some new patients not getting access to drugs when they should. So I think with a bit more discussion, people will understand the importance of getting appropriate patients on drug. I think some of the question in terms of narrowing the population is around what will the outcomes show.

我們目前花了很多時間與付款方溝通，幫助他們了解我認為是繁瑣的紙質預先授權系統帶來的意想不到的後果，導致一些新患者在應該獲得藥物的時候卻無法獲得藥物。所以我認為，經過一番討論，人們就會明白讓合適的患者接受藥物治療的重要性。我認為，縮小人口範圍的一些問題在於，結果會如何顯示。

And there's no doubt in my mind that once we have definitive proof that this drug actually results not only in lowering LDL but in actually reducing the risk of heart attack and stroke, that more patients will gain access to the drug.

我毫不懷疑，一旦我們確鑿地證明這種藥物不僅可以降低低密度脂蛋白膽固醇，而且可以降低心臟病發作和中風的風險，就會有更多的患者獲得這種藥物。

Let's go with the next question, please.

請繼續下一個問題。

Jeff Meacham, Barclays.

傑夫·米查姆，巴克萊銀行。

Good afternoon. Thanks for taking the question. I just wanted to talk a little bit about Romo, looking at the non-vertebral fracture data, do you think this could be a big variance competitively?

午安.感謝您回答這個問題。我只是想稍微談談羅莫的情況，看看非椎體骨折的數據，你認為這會在競爭中造成很大的差異嗎？

And what's the outlook for the European filing based on the PMO data? Do you think there is a risk that secondary endpoints may have to be hit on that? Thank you.

根據PMO的數據，歐洲的申報前景如何？你認為是否有需要達到次要終點的風險？謝謝。

Thanks, Jeff Sean, why don't you take those questions.

謝謝傑夫·肖恩，不如你來回答這些問題。

In terms of results, the second part of the question relates, I think to the ability to file the data set in Europe and we do believe that data will support registration as is in Europe, but we also have always planned to file both outcomes, fracture studies. So we have the alendronate controlled study in which the primary endpoint is clinical fracture that will be part of that. Part of that file.

就結果而言，問題的第二部分我認為與在歐洲提交資料集的能力有關，我們相信資料將支持在歐洲進行註冊，但我們也一直計劃提交骨折研究的結果。因此，我們有一項阿崙膦酸鈉對照研究，其主要終點是臨床骨折，這將是其中的一部分。文件的一部分。

I think that when you step back, there's a couple things. One is that we need to present these data at the appropriate scientific congresses and publish them so that the experts in the field can look at the data. Because the paradigm for the study design is so different than what people are used to with a three-year placebo-controlled portion rather than a one-year placebo-controlled portion.

我認為，當你退後一步來看，會有兩件事。其一是我們需要在相應的科學大會上展示這些數據並發表，以便該領域的專家可以查看這些數據。因為這項研究的設計範式與人們通常所習慣的截然不同，它採用的是為期三年的安慰劑對照試驗，而不是為期一年的安慰劑對照試驗。

And in the end, the most important endpoint to look at with these therapeutics we've hit, which again is the symptomatic vertebral fractures plus non-vertebral. And we had quite a significant effect size there, as well as the transition from treatment with Romosozumab on to Prolia where we continue to see benefit of Romosozumab into the second year on Prolia. Overall, I think the data will be well-received when people are able to look at it in some detail.

最終，我們透過這些療法達到的最重要終點是症狀性椎體骨折和非椎體骨折。而且我們在那裡取得了相當大的效果，以及從 Romosozumab 治療過渡到 Prolia 治療，我們在 Prolia 治療的第二年仍然看到了 Romosozumab 的益處。總的來說，我認為當人們能夠詳細查看這些數據時，這些數據將會受到歡迎。

Terence Flynn, Goldman Sachs.

特倫斯·弗林，高盛集團。

Maybe first I was wondering if you could comment on the Treasury notice on intercompany debt and any potential impact to your longer-term tax rate, and any potential for an FDA panel on Etelcalcetide. Thank you.

首先，我想問您能否就財政部關於公司間債務的通知以及對您長期稅率的任何潛在影響發表意見，以及FDA專家組對Etelcalcetide的任何可能性。謝謝。

On the first ones, first of all Amgen, of course, is not a Company that is inverted so we are US-based company. And all of our debt is issued and received from third parties so we don't see any impact on our business in terms of our ability to finance and the ability to deduct the interest expense from our earnings. So right now we don't see any impact but it's a pretty detailed and lengthy ruling, so we continue to look at it, but we don't foresee any right now.

首先，安進當然不是一家反向收購公司，我們是一家總部位於美國的跨國公司。我們所有的債務都是從第三方發行和接收的，因此我們認為這不會對我們的業務造成任何影響，包括融資能力和從收益中扣除利息支出的能力。所以目前我們還沒有看到任何影響，但這是一份相當詳細且冗長的裁決，所以我們會繼續關注，但目前我們預計不會有任何影響。

Terrance, this is Sean. We don't anticipate the need for an advisory, an FDA advisory committee for Parsabiv.

特倫斯，我是肖恩。我們預計不需要為 Parsabiv 設立諮詢委員會或 FDA 諮詢委員會。

Okay, Jake. Let's take the next question.

好的，傑克。我們來看下一個問題。

Alethia Young, Credit Suisse.

Alethia Young，瑞士信貸。

Thanks for taking my questions. I just wanted to ask about Kyprolis and if you're seeing any competition with like Darzalex or any of the other new regimens on the market? If you could give color there, that would be great.

謝謝您回答我的問題。我只是想問一下關於Kyprolis的情況，您是否看到它與Darzalex或其他市面上的新療法有競爭關係？如果你能為那裡加上顏色，那就太好了。

Okay, so let me answer that question. This is Tony. Clearly, as I said, the addition of the ENDEAVOR data to our label giving us both a doublet and a triplet regimen in second line, both with clinical data showing great efficacy versus the prior regimens has put us in a good position to give patients in second line plus a better opportunity.

好的，那我就來回答這個問題。這是托尼。顯然，正如我所說，ENDEAVOR 數據添加到我們的標籤中，使我們在二線治療中同時擁有雙藥和三藥方案，這兩種方案的臨床數據均顯示其療效優於之前的方案，這使我們能夠為二線及以上患者提供更好的治療機會。

The data in the market is quite shallow because we happened to look at the patient chart audits. But as I look at the audits for the first quarter, I see Kyprolis continue to hold market share in the third line. I see continued growth in the second line and I see the newer entrants with very low single-digit market shares and predominantly being used in fourth line plus.

由於我們只是查閱了病人病歷，所以市面上的資料相當淺薄。但從第一季的審計結果來看，Kyprolis 在第三線市場持續保持市場佔有率。我看到第二線產品持續成長，而新進業者的市佔率只有個位數，主要用於第四線及以上產品。

Cory Kasimov, JPMorgan.

科里·卡西莫夫，摩根大通。

Good afternoon. Thanks for taking the question. With regard to Repatha access. Assuming you get positive CVOT data later this year, what's your understanding of the process you will need to follow in order to ease current utilization management.

午安.感謝您回答這個問題。關於 Repatha 的使用。假設您在今年稍後獲得積極的 CVOT 數據，您認為為了簡化目前的使用率管理，您需要遵循哪些流程？

I'm wondering how fast things could open up or if you're going to need to get the data on the label and renegotiate with payers first before you're able to detect a noticeable difference on that front? Thanks.

我想知道事情進展會有多快，或者是否需要先獲得標籤數據並與付款方重新談判，才能在這方面發現明顯的差異？謝謝。

As Sean said, we're expecting the data in the latter end of this year. Once the data becomes clear, it will become public and people have to make up their minds what that actually means. It will be presented then in a peer-reviewed publication and presented at one of the large congresses where the data will become clear to all the prescribing cardiologists.

正如肖恩所說，我們預計將在今年下半年獲得相關數據。一旦數據變得清晰明了，它就會公之於眾，人們必須自己去判斷這究竟意味著什麼。屆時，研究結果將發表在同行評審的出版物上，並在大型會議上進行展示，屆時所有開處方的心臟病專家都將清楚地了解這些數據。

We, of course, from a commercial perspective, are not in a position to negotiate or talk to payers about the data until the FDA has approved it in our label. In the interim, however, our medical affairs organization can respond to questions we receive from the payers in a balanced and medical way.

當然，從商業角度來看，在 FDA 批准我們的標籤資料之前，我們無法與付款方就這些數據進行談判或討論。但在此期間，我們的醫療事務部門可以以平衡和醫學的方式回應我們從付款方收到的問題。

But I'm assuming once this becomes clear, the details will clarify the unique value of this particular product. Sean?

但我認為，一旦這點明朗化，細節就會闡明這款產品的獨特價值。肖恩？

This is Sean. I think the other comment I would make is that you may have seen that some of the US-based guidelines for treatment of hyperlipidemia and cardiovascular risk were recently updated and included the concept of using the PCSK9 inhibitors after stepping through some other therapeutic options that have the cardiovascular outcomes data.

這是肖恩。我想補充的另一點是，您可能已經注意到，美國一些關於高脂血症和心血管風險治療的指南最近進行了更新，其中納入了在嘗試了一些其他具有心血管結果數據的治療方案後使用 PCSK9 抑製劑的概念。

It's my understanding from talking with many of the key opinion leaders who are either involved in the guidelines or just thought leaders in the field, there's a clear desire to update these guidelines as fast as possible when the cardiovascular outcomes data are available. So that's an independent process from anything to do with getting drug data into the label and can be a very important thing that payers look at when they make access decisions.

根據我與許多參與制定指南或在該領域具有影響力的意見領袖交談後了解到，他們都非常希望在獲得心血管疾病結果數據後儘快更新這些指南。所以這是一個獨立於將藥物資料輸入標籤的任何過程，而且是支付方在做出准入決定時會考慮的一個非常重要的因素。

Jake, let's take the next question.

傑克，我們來看下一個問題。

Mark Schoenebaum, Evercore ISI.

Mark Schoenebaum，Evercore ISI。

Maybe a question for Bob. In this environment biotech prices have obviously come down. I'm wondering what your current feelings, Bob, are around hostile acquisitions. Thank you very much.

或許可以問問鮑伯。在這種環境下，生物技術產品的價格顯然已經下降。鮑勃，我想知道你現在對惡意收購有何看法。非常感謝。

Well, Mark, I don't know that I would make any comments about hostile acquisitions but as you've heard us say before, valuations in some areas are more attractive this year than they were last. And we have a strong balance sheet and we continue to look carefully, both internally and externally, for the most attractive programs that we can advance.

馬克，關於敵意收購，我不太想發表任何評論，但正如你之前聽我們說​​過的那樣，今年某些領域的估值比去年更有吸引力。我們擁有穩健的資產負債表，並且我們將繼續認真地從內部和外部尋找最具吸引力的項目來推進。

But we look at all range of transactions, licensing as well as M&A and we consider them each individually. So I wouldn't speculate, Mark, about anything more than that at this point.

但我們會考察所有類型的交易，包括許可交易和併購交易，我們會逐一進行評估。所以，馬克，在這一點上，我不會妄加猜測。

Michael Yee, RBC Capital Markets.

Michael Yee，加拿大皇家銀行資本市場。

Great, thanks. Question for Sean. The pivotal CGRP data is coming in and there is a wealth of data coming. You've talked in the past about your hypothesis about your mechanism and some differentiation. Can you maybe update us on your thoughts about how you still see that playing out as some more data has come out and as more data played out. Could you maybe list one or two things where you specifically see some differentiation or how that plays in the future? Thanks.

太好了，謝謝。問肖恩一個問題。關鍵的CGRP數據即將出爐，還有大量數據即將發布。你之前談過你關於機制的假設以及一些差異化。您能否更新一下您對未來發展走向的看法，尤其是在更多數據公佈和驗證之後？您能否列舉一兩點您認為存在差異的地方，或者這些差異在未來會如何發展？謝謝。

I don't think much has really changed in terms of the fact that there are fundamental scientific principles here around the difference between a receptor antagonist and the ligand. We've always felt that the receptor antagonist would be more potent and we're seeing that play out.

我認為，就受體拮抗劑和配體之間的差異而言，基本科學原理並沒有太大變化。我們一直認為受體拮抗劑會更有效，現在看來確實如此。

We've always thought that might result in a situation in which the administration profile of the product was better than it would be if larger amounts of protein were necessary for delivery, for example, on a monthly basis in a subcutaneous delivery device.

我們一直認為，如果每月透過皮下注射裝置注射大量蛋白質，那麼該產品的給藥方案可能會更好。

So I continue to think that it's a relative advantage to have a more potent agent when you're trying to administer infrequent dosing subcutaneously. But whether that will really play into being an important clinical differentiator when these products are out in the marketplaces, I think it's too soon to know.

所以我仍然認為，在嘗試進行不頻繁的皮下給藥時，使用效力更強的藥物是一個相對的優勢。但這些產品上市後，這是否真的會成為重要的臨床差異化因素，我認為現在下結論還為時過早。

Otherwise, we continue to push very hard on the product to get it to patients as fast as we can because there are about 26 million people with migraines in the United States. And among them there's somewhere on the order of eight million to 10 million who have had attempts or are currently on and off of therapy for prophylaxis.

否則，我們將繼續大力推動產品研發，盡快將其送到患者手中，因為美國約有 2,600 萬人患有偏頭痛。其中約有 800 萬至 1,000 萬人曾嘗試或目前正在接受預防性治療，或斷斷續續地接受治療。

So there's clearly a very large unmet medical need and some proportion of that population would be an appropriate population potentially for this sort of therapeutic.

因此，顯然存在著非常大的未滿足的醫療需求，而其中一部分可能適合接受這種治療。

Joshua Schimmer, Piper Jaffray.

約書亞·施默，派珀·賈弗雷。

Thanks for taking the questions. Maybe one for Sean. Amgen had such a strong track record advancing to Phase 3 programs through commercialization. I'm curious as to what there is in the Phase 2 or earlier pipeline that you're most enthusiastic to move into Phase 3? You mentioned omecamtiv. I'm curious as to what else.

謝謝您回答問題。或許給肖恩一個。安進在推進到 3 期臨床試驗項目並實現商業化方面有著非常出色的業績記錄。我很好奇，在二期或更早期的研發管線中，您最希望推進到第三期的是什麼？你提到了omecamtiv。我很想知道還有什麼。

Sure. I like to talk about that sort of thing. Certainly omecamtiv is very exciting. We also, as I mentioned, have another migraine prophylaxis antibody and of course the potential to actually develop a bi-specific antibody that would address both of those pathways is a product behind that.

當然。我喜歡談論這類事情。omecamtiv 的確非常令人興奮。正如我之前提到的，我們還有另一種偏頭痛預防抗體，當然，開發一種能夠同時針對這兩種途徑的雙特異性抗體的潛力，也是該產品背後的目標。

Heart failure does remain a real focus for us and we actually are introducing a completely novel heart failure medicine into the clinic in a matter of days from now, which is exciting. And have quite a few early discovery level programs in that area. Cardiovascular more broadly we have some very interesting things we're working on in the early and mid-stage pipeline.

心臟衰竭仍然是我們關注的重點，而且我們實際上將在幾天後將一種全新的心臟衰竭藥物引入臨床，這令人興奮。而我們在這個領域還有不少早期探索階段的項目。在更廣泛的心血管領域，我們有一些非常有趣的研究計畫正處於早期和中期研發階段。

And, of course, the BiTE platform has a very large number of products in preclinical phases that are moving toward the clinic and we're seeing a situation in which we're going to be introducing into the clinic multiple different therapies in some cases with different targets directed at the same hematological malignancy, for example, and they are having to envision some interesting multi-armed clinical trials to try to get some efficiency in the testing when we have so many things coming forward simultaneously.

當然，BiTE 平台有大量處於臨床前階段的產品正在向臨床推進，我們看到的情況是，在某些情況下，我們將向臨床引入多種不同的療法，這些療法針對的是同一种血液惡性腫瘤，具有不同的靶點。因此，他們不得不設想一些有趣的多臂臨床試驗，以便在有這麼多產品同時推出時提高測試效率。

So there's a lot going on. Because of everything that happened it's happening at the commercialization interface, we don't get a lot of time to talk about that and perhaps we'll have an opportunity in an upcoming business review setting to go through some of this in some more detail.

所以現在發生了很多事。由於所有發生的事情都發生在商業化介面，我們沒有太多時間討論這個問題，也許在即將到來的業務審查會議上，我們會有機會更詳細地探討其中的一些問題。

Robyn Karnauskas, Citi.

Robyn Karnauskas，花旗銀行。

Thanks for taking my question. Just thinking a little bit big picture on Repatha launch, I think you called it a slow launch and you were talking about working with payers. How much are you willing to participate and deal with price versus, say, mortality outcomes? So what's the balance of lowering price and mortality outcomes as far as opening up access? Thanks.

謝謝您回答我的問題。從宏觀角度思考一下 Repatha 的上市，我想你稱之為緩慢上市，你也談到了與支付方的合作。你願意在多大程度上參與並處理價格與死亡率等結果之間的關係？那麼，在開放醫療服務取得管道的同時，如何平衡降低價格和降低死亡率之間的關係呢？謝謝。

Robyn, it's Tony. Clearly, as we said, we bring our products to market with a clear debate and discussion around the pharmacoeconomic value of the products. There was an extrapolated value that these drugs would actually result in reduction of both stroke, heart attack and early untimely death.

羅賓，我是東尼。正如我們所說，我們在將產品推向市場之前，會圍繞產品的藥物經濟學價值進行明確的辯論和討論。有推論表明，這些藥物實際上可以降低中風、心臟病發作和過早死亡的風險。

And I think we will continue to bring the value to market. There are rebates in the marketplace at the moment and that dynamic will continue over time as we jostle for formulary positions. But I think what we bring to market at the moment is a pretty decent and acceptable value proposition to treat patients at high risk.

我認為我們將繼續為市場帶來價值。目前市面上有回扣，隨著我們爭奪藥品目錄位置，這種動態還會持續下去。但我認為，我們目前推向市場的產品對於治療高風險患者來說，是一個相當不錯且可接受的價值主張。

Eun Yang, Jefferies.

楊恩，傑富瑞集團。

A question on Parsabiv. With the bundled payment in dialysis, what do you think could the pricing power could be for the product like this, particularly when Sensipar is expected to go generic in a couple of years? Thanks.

關於 Parsabiv 的一個問題。在透析治療採用打包支付模式的情況下，您認為這類產品的定價權會有多大？特別是考慮到 Sensipar 預計在幾年內就會上市仿製藥。謝謝。

It's Tony. Let me answer this one. As you know, CMS have granted a two-year period that this product will operate outside the bundle under the ASP pricing method which will give CMS two years to evaluate the product value and then to make a decision how much value is put into the bundle when the product moves from ASP into the bundle.

是托尼。讓我來回答這個問題。如您所知，CMS 已給予該產品兩年的時間，使其在捆綁包之外按照 ASP 定價方法運營，這將給 CMS 兩年的時間來評估產品價值，然後決定當該產品從 ASP 轉入捆綁包時，捆綁包中應包含多少價值。

Ying Huang, BofA Merrill Lynch.

黃穎，美國銀行美林證券。

Thanks for taking my question. First one for Sean to talk about a CV outcome trial here. I know you never disclose the powering assumption or the assumption for event rate but should we assume that it's probably similar to what your competitor has talked about?

謝謝您回答我的問題。首先，讓肖恩來談談心血管疾病預後試驗。我知道你們從未透露過功率假設或事件發生率假設，但我們是否可以假設它可能與你們的競爭對手所說的類似？

And secondly I have a question on the Epo market. First Fresenius switching to Mircera for Roche, you have a long-term contract with DaVita. What is your thought of the other one- third of the market with Epo and Aranesp going forward?

其次，我還有一個關於EPO市場的問題。首先，費森尤斯將羅氏的Mircera產品轉而使用，而你與DaVita簽有長期合約。您如何看待 Epo 和 Aranesp 未來佔據的另外三分之一的市場份額？

I will take this in two parts. Sean will take your first question and Tony can address your Epo question.

我將分兩部分來講解。Sean會回答你的第一個問題，Tony可以回答你關於Epo的問題。

Actually both we and Regeneron and Sanofi have published papers on the design of these studies where there's quite a bit of detail in the way they were constructed. And in the end, these studies, types of studies differ largely in the issue of how long it takes to enroll the population and what the event rate is once you get patients enrolled.

事實上，我們和 Regeneron 以及 Sanofi 都發表過關於這些研究設計的論文，其中詳細介紹了這些研究的建構方式。最終，這些研究、研究類型之間的很大差異體現在招募人群所需的時間以及招募患者後的事件發生率。

We don't believe -- we would not anticipate large differences in the event rates between the two populations. But there will be some difference in event rate. And I think both companies have set their studies up so that they would be able to detect what was considered to be a clinically meaningful minimum effect size, so typically one would set these kind of trials up so that you wouldn't miss a 20% reduction in risk.

我們認為－我們預期這兩個人群的事件發生率不會有很大差異。但事件發生率會有一些差異。我認為這兩家公司都已設計了研究方案，以便能夠檢測到被認為具有臨床意義的最小效應量，因此通常情況下，這類試驗的設計目的就是為了不錯過 20% 的風險降低。

Obviously you may be looking for more, but that would be the way you powered the trial. There's more similarities than there are differences.

顯然您可能想要更多，但這正是您進行試驗的方式。相似之處多於不同之處。

So let me answer your question on the dialysis market. You're right, the market is broken into three. DaVita is responsible for about one-third of the market. We have contract with them that is exclusive and runs through 2018.

那麼就讓我來回答你關於透析市場的問題。你說得對，市場分為三類。DaVita 佔據了約三分之一的市佔率。我們與他們簽訂了獨家合同，有效期至 2018 年。

Fresenius, who is another one-third of the market, are in the process of converting a lot of their patients. The last time they made any numbers public, they were talking about just over 70% conversion to Mircera.

費森尤斯公司佔據了三分之一的市場份額，目前正在努力轉化大量患者。他們上次公開數據時，說的是 Mircera 的轉換率略高於 70%。

The other one-third of the market is the independent, medium and small dialysis units. In that setting we have converted about 70% of the EPOGEN usage to Aranesp.

市場其餘三分之一是獨立營運的中小型透析中心。在這種情況下，我們將大約 70% 的 EPOGEN 使用量轉換為 Aranesp。

Geoff Porges, Leerink Partners.

Geoff Porges，Leerink Partners。

Thank you. I appreciate the question. Tony, a couple for you. Could you talk a little bit about price and Enbrel? The contribution of price. Should we just infer that it's a difference between the growth, the units and the inventory? It looks about 20%. And could you just talk about whether that looks to be sustainable given the market environment?

謝謝。感謝您的提問。東尼，給你一對。您能談談價格和恩利（Enbrel）嗎？價格因素的影響。我們是否可以推論這是成長量、銷售量和庫存量之間的差異？看起來大約是20%。鑑於當前的市場環境，您能否談談這種做法是否具有永續性？

And on a related note, could you talk about the value proposition for AMG 334? Certainly millions of patients out there with migraine, but you can imagine payers preparing to do some of the things that they did for Repatha. How do you think you're going to approach the value proposition, that indication to avoid the really tight restrictions you've encountered?

另外，您能否談談AMG 334的價值主張？當然，有數百萬偏頭痛患者，但你可以想像，支付方正在準備採取一些他們對待瑞百安（Repatha）的方式。你打算如何闡述價值主張，並說明如何避免你所遇到的那些非常嚴格的限制？

Let's go back to the pricing. Just to reconfirm again. What we report and what we talk about in terms of net price. And really that's a combination of the list price minus the rebates and/or formulary positions you have in the marketplace.

我們再回到定價問題上來。再確認一下。我們報導和討論的內容都以淨價為準。實際上，這是標價減去你在市場上的折扣和/或處方集地位的總和。

I think as a Company we are acutely aware of the issues facing the industry in the US at the moment. But Amgen's all about innovation, right? So we price our drugs around the pharmacoeconomic value of the products as we bring them to market. Enbrel itself, of course, is competing in a highly competitive marketplace where several large players are competing for formulary position to enable patient access.

我認為，作為一家公司，我們非常清楚目前美國產業面臨的問題。但安進的宗旨就是創新，對吧？因此，我們在將藥品推向市場時，會根據產品的藥物經濟學價值來定價。當然，恩利本身也身處一個競爭非常激烈的市場，多家大型企業都在爭奪藥品目錄地位，以確保患者能夠獲得該藥物。

At the same time, the health plans and the PBMs are negotiating price concessions and large rebates to set up formulary placement and it's because of the magnitude of these rebates that price increases have become part of this overall dynamic. So it's an integrated process flow as we go forward.

同時，健康計畫和藥品福利管理機構正在協商價格讓步和大額回扣，以確立藥品目錄的地位，正是由於這些回扣的規模，價格上漲才成為這種整體動態的一部分。所以，這是一個我們逐步推進的綜合流程。

Talking about 334, as Sean has said again and again, this is a huge unmet medical need in the marketplace where existing therapies have side effects that are sometimes as bad as the disease itself. Unlike most other diseases, patients with chronic migraine really know about it. It's debilitating. It is devastating.

談到 334，正如肖恩反覆強調的那樣，這是市場上一個巨大的未滿足的醫療需求，現有療法的副作用有時與疾病本身一樣嚴重。與其他大多數疾病不同，慢性偏頭痛患者對這種疾病有著切身體會。這令人痛苦不堪。這太令人震驚了。

And some of the initial research we've done have shown a much higher inclination or preparedness to pay a co-pay because patients really want to get rid of the disease as quick as they can. I think most of the patients who are available to us have been on therapy for some time and were able to show they've been on therapy, so step edits I'm sure will be there. But there's a large bolus of patients who failed consistently on existing treatment in the marketplace.

我們進行的一些初步研究表明，患者更傾向於或願意支付共同支付費用，因為他們真的希望盡快擺脫疾病。我認為我們能接觸到的大多數患者都已經接受治療一段時間了，並且能夠證明他們一直在接受治療，所以我相信肯定會有步驟修改。但市面上有大量患者對現有療法持續無效。

I'm noticing it is fast approaching 6:30 on the East Coast. Why don't we take two last questions.

我注意到東海岸時間很快就要到6:30了。我們不妨回答最後兩個問題。

Jim Birchenough, Wells Fargo Securities.

吉姆·伯奇諾，富國證券。

Thanks for squeezing us in. This is actually Yanan Zhu in for Jim. I wanted to ask a question on the CGRP program, specifically on the regulatory path. As you know, it's a competitive space with four players. You have the clear lead, the first Phase 3 data readout for that frequent episodic migraine indication.

謝謝你們擠出時間接待我們。其實是茱亞楠代替吉姆上場。我想問一個關於 CGRP 計畫的問題，特別是關於監管途徑的問題。如你所知，這是一個有四名玩家的競爭領域。你們擁有明顯的領先優勢，率先公佈了治療頻繁發作性偏頭痛的 3 期臨床試驗數據。

However, in a chronic migraine indication it's a little less clear because others have Phase 3 programs ongoing. You interest me. You just mentioned -- you commented that you might use the Phase 2 data that is going to read out, the Phase 2-B data in chronic migraine to support a BLA.

然而，對於慢性偏頭痛的適應症，情況就不太明朗了，因為其他一些研究正在進行第三階段的試驗。你引起了我的興趣。您剛才提到——您評論說，您可能會使用即將公佈的 2 期數據，即慢性偏頭痛的 2-B 期數據來支持 BLA。

Our question is, do you think you will seek a chronic migraine indication based on the Phase 2-B data? Has there been any discussion with regulators on that? Thanks.

我們的問題是，您認為您會根據 2-B 期數據尋求慢性偏頭痛適應症嗎？是否就此與監管機構進行討論？謝謝。

This is Sean. I think that the things you have to take into account is that the chronic migraine Phase 2-B study is quite a large study. And it explores doses that are used in the two large Phase 3 episodic migraine studies.

這是肖恩。我認為你需要考慮的一點是，慢性偏頭痛 2-B 期研究是一項相當大的研究。它還探討了在兩項大型 3 期發作性偏頭痛研究中使用的劑量。

These are obviously -- there is a spectrum of disease here and while there is a separate regulatory entity of chronic migraine and episodic migraine, the pathophysiology is probably quite shared across these as evidenced by the fact that all the CGRP antagonists are having similar efficacy in the different patient populations. So it's our feeling that, taken together, the data could potentially support both indications being granted, at least by some of the global regulators.

顯然，這些疾病屬於一個譜系，雖然慢性偏頭痛和發作性偏頭痛有單獨的監管實體，但它們的病理生理機制可能相當相似，所有 CGRP 拮抗劑在不同患者群體中都具有相似的療效，這證明了這一點。因此我們認為，綜合來看，這些數據可能支持批准這兩種適應症，至少有些全球監管機構會這麼認為。

And I would not typically go into the discussions about the specific conversations we've had with regulators, but I'd just say that we feel that it's a very reasonable approach to attempt to get both indications based on the aggregate data package.

我通常不會深入討論我們與監管機構的具體對話內容，但我只想說，我們認為嘗試根據匯總資料包來獲取這兩個指標是一個非常合理的方法。

Great. Let's take one last question.

偉大的。我們來看最後一個問題。

Jeff Chen, Cowen and Company.

Jeff Chen，Cowen and Company。

Thanks for taking my question. For Tony. Can you just discuss a little bit more about Repatha in the EU and Japan in terms of your experience of access and reimbursement? And if you think that the CVOT outcomes data will change the negotiation or would that be a new round of negotiations? Thanks.

謝謝您回答我的問題。致托尼。您能否再詳細談談您在歐盟和日本使用Repatha的經驗，包括取得藥物和報銷方面的情況？您認為 CVOT 結果數據會改變談判走向，還是引發新一輪談判？謝謝。

I think you've heard people talk about the Entresto performance in Europe where once the price has been set and reimbursement is agreed, there is no longer an economic decision around every prescription, so uptake happens quite fast. I believe that as we get into growing into this marketplace, pricing is just about set.

我想你一定聽過人們談論 Entresto 在歐洲的表現，一旦價格確定，報銷也達成一致，每張處方就不再需要經濟決策，因此推廣速度非常快。我認為，隨著我們在這個市場中不斷發展壯大，價格也基本定型了。

When you come in with larger expanded patient population groups, there's a chance in Europe you have to go back into a country-by- country negotiation. In Japan, historically, that hasn't happened as much and the pricing we received in Japan seems to be a longer play-through from pricing.

當你在歐洲面對更大規模的患者群體時，你很可能需要重新進行逐個國家的談判。在日本，從歷史上看，這種情況並不常見，我們在日本獲得的價格似乎是經過更長的市場消化過程才形成的。

Great. Thank you, everybody, for your participation on this busy, busy day. Of course, I'll be around together with the rest of my team so if we can offer any further assistance, please give me a call. Have a good day.

偉大的。感謝各位在今天這個繁忙的日子裡參與我們的活動。當然，我和我的團隊其他成員都會在附近，所以如果我們能提供任何進一步的幫助，請隨時打電話給我。祝你有美好的一天。

Ladies and gentlemen, this concludes Amgen's first-quarter financial results conference call. You may now disconnect.

女士們、先生們，安進公司第一季財務業績電話會議到此結束。您現在可以斷開連線了。