美國安進 (AMGN) 2014 Q2 法說會逐字稿

My name is Marvin and I will be your conference facilitator today for Amgen's second-quarter earnings conference call.

我叫馬文，今天我將擔任安進第二季度財報電話會議的會議主持人。

(Operator Instructions)

（操作員說明）

I would now like to introduce Arvind Sood, Vice President of Investor Relations.

我現在想介紹投資者關係副總裁 Arvind Sood。

Mr. Sood you may now begin.

Sood 先生，您現在可以開始了。

Okay, thank you, Marvin.

好的，謝謝你，馬文。

Good afternoon, everybody.

大家下午好。

I'd like to welcome you to our conference call to review our operating results for the second quarter.

歡迎您參加我們的電話會議，回顧我們第二季度的經營業績。

Our new CFO, and my new boss, David Meline, actually picked a great quarter to join us, as our business performance was strong across the board.

我們的新首席財務官和我的新老闆大衛梅林實際上選擇了一個很好的季度加入我們，因為我們的業務表現全面強勁。

Our CEO, Bob Bradway, will introduce David formally in just a couple of minutes, and will also review our strategic progress and actions we are taking to position ourselves for long-term growth.

我們的首席執行官 Bob Bradway 將在短短幾分鐘內正式介紹 David，還將回顧我們的戰略進展和我們為實現長期增長而採取的行動。

Following Bob, David will review our second-quarter performance.

在 Bob 之後，David 將回顧我們第二季度的業績。

Our Head of Global Commercial Operations, Tony Hooper, will then discuss our product performance during the quarter and trends that we see going forward.

我們的全球商業運營主管 Tony Hooper 隨後將討論我們本季度的產品性能以及我們看到的未來趨勢。

Following Tony, our Head of R&D, Sean Harper, will provide a brief update on the many late-stage opportunities we have in our pipeline, as well as progress we are making on the regulatory submissions.

在托尼之後，我們的研發主管肖恩哈珀將簡要介紹我們在管道中的許多後期機會，以及我們在監管提交方面取得的進展。

After Sean's comments, Bob will make a few concluding comments and then we should have plenty of time for Q&A.

在 Sean 的評論之後，Bob 將做一些總結性評論，然後我們應該有充足的時間進行問答。

We will use slides for our presentation today.

我們今天將使用幻燈片進行演示。

These slides have been posted on our website and a link was sent separately by email.

這些幻燈片已發佈在我們的網站上，並通過電子郵件單獨發送了一個鏈接。

You will notice that we have made some significant additions to our quarterly slide deck.

您會注意到我們對季度幻燈片進行了一些重要的補充。

This change was made in the spirit of providing more disclosure to further your understanding of our product trend drivers.

本著提供更多信息以加深您對我們產品趨勢驅動因素的理解的精神，進行了此更改。

And of course this will give my friend, Mark Schoenebaum, something to talk about in his next few weekly videos.

當然，這會讓我的朋友 Mark Schoenebaum 在他接下來的幾個每週視頻中談論一些話題。

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.

我們今天的評論將受我們的安全港聲明的約束，該聲明概括地說，通過我們今天的介紹和討論，我們可能會做出某些前瞻性聲明，實際結果可能會有重大差異。

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

因此，我想將電話轉給 Bob。

Okay.

好的。

Thank you, Arvind.

謝謝你，阿文德。

Let me begin by welcoming David Meline as our Chief Financial Officer.

首先讓我歡迎 David Meline 擔任我們的首席財務官。

David joins us from 3M, and his financial leadership and broad international experience will be very helpful to Amgen as we execute our strategy for long-term growth and launch our pipeline of medicines in a number of new geographies.

David 從 3M 加入我們，他的財務領導能力和廣泛的國際經驗將對 Amgen 非常有幫助，因為我們將執行我們的長期增長戰略並在許多新地區推出我們的藥物產品線。

I'd also like to thank Michael Kelly for serving as our acting CFO prior to David's appointment.

我還要感謝邁克爾凱利在大衛被任命之前擔任我們的代理首席財務官。

Our performance was strong across the board in the second quarter and our confidence in the business was buoyed by our 11% revenue growth, 30% operating income growth, and 25% earnings per share growth for the period.

我們在第二季度的整體表現強勁，我們對業務的信心受到同期 11% 的收入增長、30% 的營業收入增長和 25% 的每股收益增長的提振。

Our recently launched and legacy brands performed well in the US and internationally, and we exercised expense discipline across the business to drive these results.

我們最近推出的品牌和傳統品牌在美國和國際上表現良好，我們在整個業務中實施了費用紀律以推動這些結果。

Based on our progress through the first half of the year, and our confidence in the underlying trends of the business, we are raising guidance as David will explain shortly.

根據我們上半年的進展以及我們對業務基本趨勢的信心，我們正在提高指引，大衛將在稍後解釋。

Because we will be talking on this call both about our quarterly results and some restructuring activity, I'd like to just take a moment to set some strategic context.

因為我們將在這次電話會議上討論我們的季度業績和一些重組活動，所以我想花點時間來設定一些戰略背景。

Our strategy for long-term growth begins with a commitment to developing a robust, differentiated pipeline of new medicines addressing serious illness.

我們的長期增長戰略始於致力於開發強大的、差異化的新藥管線來治療嚴重疾病。

This strategy is beginning to bear fruit.

這一戰略開始見效。

We've talked about our substantial portfolio of 10 late-stage molecules delivering pivotal data by 2016.

我們已經討論了我們在 2016 年之前提供關鍵數據的 10 種後期分子的大量產品組合。

So far in 2014, we've reported positive pivotal data for five of these molecules and we have submitted two of them already in the US; Ivabradine, for chronic heart failure, and T-Vec, for malignant melanoma.

2014 年到目前為止，我們已經報告了其中五個分子的積極關鍵數據，並且我們已經在美國提交了其中兩個；伊伐布雷定用於慢性心力衰竭，T-Vec 用於惡性黑色素瘤。

In Q3 we expect to submit Evolocumab in the US and Europe, T-Vec in Europe, and later in the year, blinatumomab in the US with the breakthrough therapy designation.

在第三季度，我們預計將在美國和歐洲提交 Evolocumab，在歐洲提交 T-Vec，並在今年晚些時候在美國提交具有突破性治療指定的 blinatumomab。

This presents us with the prospect of several high potential new product launches beginning in 2015.

這向我們展示了從 2015 年開始推出幾款高潛力新產品的前景。

To capitalize on this opportunity, we announced today the first steps of a restructuring plan designed to improve our focus and proactively reallocate resources ahead of the commercialization of our many promising molecules on a cost-competitive basis.

為了利用這個機會，我們今天宣布了一項重組計劃的第一步，旨在提高我們的重點，並在我們許多有前途的分子商業化之前以具有成本競爭力的方式主動重新分配資源。

Our initial efforts include streamlining our organization, reducing layers of management, increasing managerial spans of responsibility, and beginning implementation of a revised geographic site plan.

我們最初的努力包括精簡我們的組織、減少管理層級、增加管理責任範圍以及開始實施修訂後的地理站點計劃。

In this regard we'll reduce our workforce by between 2,400 and 2,900 positions, beginning in the fourth quarter of 2014 and continuing through 2015, predominantly in the United States.

在這方面，我們將從 2014 年第四季度開始並持續到 2015 年，主要在美國裁員 2,400 至 2,900 個職位。

This represents approximately 12% to 15% of Amgen's global workforce of some 20,000 staff members.

這約佔安進全球約 20,000 名員工的 12% 至 15%。

The significant element of our current restructuring plan involves optimizing our sites in the United States.

我們當前重組計劃的重要組成部分涉及優化我們在美國的網站。

As part of this, we plan to close all of our facilities in Washington and Colorado by the end of 2015.

作為其中的一部分，我們計劃在 2015 年底之前關閉我們在華盛頓和科羅拉多州的所有設施。

We'll begin the process of exiting these sites in the third quarter of this year.

我們將在今年第三季度開始退出這些網站。

These sites were primarily research and development and manufacturing facilities.

這些地點主要是研發和製造設施。

Going forward, we see opportunities to concentrate more of our research and process development activities in our sites in South San Francisco and Cambridge, Massachusetts, obviously two key biotechnology hubs.

展望未來，我們看到機會將更多的研究和工藝開發活動集中在我們位於南舊金山和馬薩諸塞州劍橋的工廠，這顯然是兩個重要的生物技術中心。

We will retain our headquarters in Thousand Oaks, albeit with a reduced number of staff, and overall we anticipate approximately a 23% reduction in our facilities footprint as part of this first step in our restructuring.

我們將保留我們在千橡市的總部，儘管員工人數有所減少，總體而言，作為我們重組第一步的一部分，我們預計我們的設施足跡將減少約 23%。

These actions will result in pretax accounting charges in the range of $775 million to $950 million, primarily incurred in 2014 and 2015.

這些行動將導致 7.75 億美元至 9.5 億美元的稅前會計費用，主要發生在 2014 年和 2015 年。

The combination of these actions will reduce operating expenses by approximately $700 million in 2016, as compared to 2013, although most of the savings will be reinvested to support global launches of our new products.

與 2013 年相比，這些行動的結合將使 2016 年的運營費用減少約 7 億美元，儘管大部分節餘將用於支持我們新產品的全球發布。

These actions were contemplated as part of our 2014 guidance, and the financial benefit will be modest in 2015 due to the timing of these actions during the calendar year.

這些行動被視為我們 2014 年指南的一部分，由於這些行動的時間安排在日曆年，因此 2015 年的財務收益將是適度的。

Let me just point out that the initiatives I've described represent the first steps in our strategic resource reallocation efforts.

我只想指出，我所描述的舉措代表了我們戰略資源重新分配工作的第一步。

For much of the past year, teams across Amgen have engaged in a coordinated effort to reengineer our Company for the future.

在過去一年的大部分時間裡，Amgen 的團隊一直在協調努力，為未來重新設計我們的公司。

They are focused on ensuring that we build exactly the right capabilities to deliver on our strategy and our aspirations.

他們專注於確保我們建立正確的能力來實現我們的戰略和我們的願望。

As part of this, we've been evaluating our overall expense base, our fixed costs, our variable costs, our labor-related expenses, and our financing costs.

作為其中的一部分，我們一直在評估我們的整體費用基礎、我們的固定成本、我們的可變成本、我們的勞動力相關費用和我們的融資成本。

Our next steps, which are well underway, include evaluating additional efficiency initiatives, particularly in the shared services area.

我們正在進行的後續步驟包括評估額外的效率舉措，特別是在共享服務領域。

We'll discuss our full program with you, together with an estimate of the resulting cost savings, pipeline progress, and our commercial plans during a business review meeting that we will be hosting in the fourth quarter.

在我們將在第四季度舉辦的業務審查會議上，我們將與您討論我們的完整計劃，以及由此產生的成本節約、管道進度和我們的商業計劃的估計。

I would emphasize today that we begin these actions with a strong underlying confidence in our business.

我今天要強調的是，我們以對我們業務的強大潛在信心開始這些行動。

Our confidence is bolstered by our strong operating performance and the widespread positive reception to our Evolocumab data, and by our expectations for the well-designed ASPIRE trial for Kyprolis, results for which will be announced as soon as they are available.

我們強大的運營業績和對我們的 Evolocumab 數據的廣泛積極接受，以及我們對精心設計的 Kyprolis ASPIRE 試驗的期望，將在結果可用後立即公佈，這增強了我們的信心。

Let me now turn the call over to David Meline who will walk you through the financials for our second quarter.

現在讓我將電話轉給 David Meline，他將向您介紹我們第二季度的財務狀況。

Okay.

好的。

Thanks, Bob.

謝謝，鮑勃。

I'm pleased to join Amgen at this pivotal time.

我很高興在這個關鍵時刻加入安進。

I look forward to working with the team in order to support the global growth of the Company, while helping to prioritize the best opportunities for products and programs which will serve the Company's mission.

我期待著與團隊合作，以支持公司的全球發展，同時幫助優先考慮將服務於公司使命的產品和計劃的最佳機會。

We will also ensure that the Company is efficient and lean in order to maintain competitiveness and support our capital allocation plans.

我們還將確保公司高效精簡，以保持競爭力並支持我們的資本配置計劃。

I look forward to expanding on these themes during the fourth-quarter business review.

我期待在第四季度業務回顧期間擴展這些主題。

Turning to page 5 of the presentation, Amgen's revenue grew by 11% year over year, with 8% product sales growth driven by strength across the product portfolio, both in the US and internationally.

翻到演示文稿的第 5 頁，Amgen 的收入同比增長 11%，產品銷售增長 8%，這得益於美國和國際產品組合的實力。

We also saw a nearly $150 million increase in other revenues, primarily due to our Nexavar and Stivarga partnerships.

我們還看到其他收入增加了近 1.5 億美元，這主要歸功於我們與 Nexavar 和 Stivarga 的合作夥伴關係。

On a quarter-over-quarter basis, revenues grew 15%.

按季度計算，收入增長了 15%。

This is consistent with our product sales pattern in recent years.

這與我們近年來的產品銷售模式是一致的。

However, the increase was a bit sharper this year, in part due to inventory build for Enbrel of about $60 million in Q2, which Tony will discuss in more detail shortly.

然而，今年的增長幅度更大一些，部分原因是第二季度 Enbrel 的庫存增加了約 6000 萬美元，Tony 稍後將對此進行更詳細的討論。

Operating income grew 30%, based on the combination of solid revenue growth along with reduced operating expenses which were down year over year.

營業收入增長 30%，這得益於穩健的收入增長以及同比下降的營業支出減少。

Within operating expenses, cost of sales increased by 0.4 points to 15.9% of sales, due to the impact of the Puerto Rico excise tax.

在營業費用中，由於波多黎各消費稅的影響，銷售成本增加了 0.4 個百分點，達到銷售額的 15.9%。

Research and development expenses increased by 4% year over year, driven by the addition of the Onyx programs, offset partially by reduced expenses associated with support of marketed products.

在增加 Onyx 計劃的推動下，研發費用同比增長 4%，部分被與上市產品支持相關的費用減少所抵消。

SG&A expenses decreased by 12%, driven by significant reduction in Enbrel related expenses.

由於 Enbrel 相關費用大幅減少，SG&A 費用下降了 12%。

Other income and expenses were $144 million in the quarter, which was flat year over year.

本季度其他收入和支出為 1.44 億美元，同比持平。

Tax rate for the quarter was 16.2%, a 4.3 point increase versus the second quarter of 2013, due primarily to the geographic earnings mix and the absence of the R&D tax credit versus the year ago period.

本季度的稅率為 16.2%，與 2013 年第二季度相比增加了 4.3 個百分點，這主要是由於地域收益組合以及與去年同期相比沒有研發稅收抵免。

As a result, adjusted net income increased 26% for the quarter and adjusted earnings per share increased 25%.

因此，本季度調整後淨收入增長 26%，調整後每股收益增長 25%。

Now turning next to cash flow and the balance sheet on page 6. We generated $2.1 billion in free cash flow in the second quarter of 2014, a $600 million year-over-year increase, due primarily to the impact of higher sales and improvements in working capital.

現在轉到第 6 頁的現金流和資產負債表。我們在 2014 年第二季度產生了 21 億美元的自由現金流，同比增長 6 億美元，這主要是由於更高的銷售額和改進的影響營運資金。

Dividend payments in the quarter totaled $0.5 billion, reflecting the 30% year-over-year dividend increase.

本季度的股息支付總額為 5 億美元，反映出股息同比增長 30%。

At quarter end, Amgen held over $26 billion in cash and short-term investments, up over $4 billion versus a year ago, and our debt balance was $33 billion.

截至季度末，安進持有超過 260 億美元的現金和短期投資，比一年前增加超過 40 億美元，我們的債務餘額為 330 億美元。

The quarter-end debt and cash balances include the impact of pre-funding a majority of our $2 billion debt maturity later this year.

季度末債務和現金餘額包括為今年晚些時候到期的 20 億美元債務中的大部分提供預融資的影響。

Turning to page 7, Amgen is increasing its revenue guidance for 2014 to $19.5 billion to $19.7 billion, and adjusted EPS guidance to $8.20 to $8.40 a share.

翻到第 7 頁，Amgen 將其 2014 年的收入指引上調至 195 億至 197 億美元，並將每股收益指引調整至 8.20 至 8.40 美元。

We are reaffirming our tax rate guidance of 15% to 16% for the year, which assumes that the R&D tax credit will be extended in 2014 and applied retroactively to the full year.

我們重申今年 15% 至 16% 的稅率指導，假設研發稅收抵免將在 2014 年延長並追溯至全年。

At this point, our best view on timing is that the R&D tax credit extension would happen in the fourth quarter, which would result in a lower tax rate in Q4, as compared to the first three quarters of 2014.

在這一點上，我們對時間的最佳看法是研發稅收抵免延期將在第四季度進行，這將導致第四季度的稅率低於 2014 年前三個季度。

Our guidance on capital expenditures remains unchanged.

我們對資本支出的指引保持不變。

Finally on slide 8, we see a summary of the financial impacts from the restructuring announced today.

最後在幻燈片 8 上，我們看到了今天宣布的重組的財務影響摘要。

Specifically we will be incurring pretax GAAP charges of $775 million to $950 million in 2014 and 2015.

具體而言，我們將在 2014 年和 2015 年產生 7.75 億美元至 9.5 億美元的稅前 GAAP 費用。

In the second half of 2014, we expect an EPS impact of $0.36 to $0.45 per share on a GAAP basis, with the balance occurring substantially in 2015.

2014 年下半年，我們預計 EPS 在 GAAP 基礎上的影響為 0.36 美元至 0.45 美元，而 2015 年將大幅平衡。

Roughly 40% of total expenses will be on a cash basis.

總支出的大約 40% 將以現金為基礎。

Based on the timing of the program, savings for 2014 are reflected in the full-year guidance.

根據計劃的時間安排，2014 年的節餘反映在全年指導中。

And as a reminder, operating expenses tend to be more heavily weighted towards the second half of the year, and we expect that again to occur in 2014.

提醒一下，下半年運營費用的權重往往更大，我們預計 2014 年會再次出現這種情況。

While capital investments will also be required as part of these restructuring actions, we are maintaining our capital investment guidance for 2014, and in the future, expect to fund these investments within the capital expense run rate of approximately $800 million.

雖然作為這些重組行動的一部分也需要資本投資，但我們將維持 2014 年的資本投資指導方針，並且在未來，預計將在約 8 億美元的資本支出運行率內為這些投資提供資金。

We look forward to discussing our full program in greater detail at our business review meeting in the fourth quarter.

我們期待在第四季度的業務審查會議上更詳細地討論我們的完整計劃。

Let me now turn this over to Tony.

現在讓我把這個交給托尼。

Thanks David.

謝謝大衛。

You'll find a summary of our global sales performance for the second quarter on slide number 10.

您可以在第 10 張幻燈片上找到我們第二季度全球銷售業績的摘要。

The strong underlying demand we saw in quarter one continued into quarter two, as our legacy product franchises remain stable despite new competition, and our growth phase products continue to increased demand from both share and market growth.

我們在第一季度看到的強勁潛在需求一直持續到第二季度，因為儘管存在新的競爭，但我們的傳統產品特許經營權仍保持穩定，而我們的成長期產品繼續增加市場份額和市場增長的需求。

As a result, we delivered 8% year-over-year sales growth in quarter two, driven by solid unit demand and to a lesser extent, price, as shown on slide number 11.

結果，我們在第二季度實現了 8% 的銷售額同比增長，這得益於穩定的單位需求以及較小程度上的價格，如幻燈片 11 所示。

You will recall that last year, we realized the benefit of the Medicaid rebate adjustment in the amount of $185 million, which negatively impacted the year-on-year comparison this year by about 4 percentage points.

你會記得，去年，我們實現了 1.85 億美元的醫療補助回扣調整收益，這對今年的同比產生了約 4 個百分點的負面影響。

This adjustment mostly impacted our ESA and Filgrastim products.

這一調整主要影響了我們的 ESA 和 Filgrastim 產品。

Our performance was particularly strong in the international markets, with 13% year-on-year growth, driven by strong performance in Europe, and we also benefited from the acquisition of Pegfilgrastim rights from Roche in several new and emerging markets.

我們在國際市場的表現尤其強勁，同比增長 13%，這主要得益於歐洲的強勁表現，我們還受益於從羅氏收購 Pegfilgrastim 在幾個新興市場的權利。

Now to slide 12, where on a sequential basis sales grew 14% due to the rebound of the inventory dynamic in quarter one and solid unit demand.

現在幻燈片 12，由於第一季度庫存動態的反彈和穩定的單位需求，銷售額環比增長 14%。

We exited quarter two with wholesale inventory levels within our normal range.

我們以批發庫存水平在正常範圍內退出了第二季度。

Let's review our second-quarter product performance, beginning with Neulasta and Neupogen on slides 13 and 14.

讓我們回顧一下我們第二季度的產品表現，從幻燈片 13 和 14 上的 Neulasta 和 Neupogen 開始。

Neulasta sales were relatively flat year on year.

Neulasta 的銷售額同比相對持平。

Positive contribution from price was partially offset by the positive Medicaid rebate adjustment in quarter two of last year.

去年第二季度積極的醫療補助退稅調整部分抵消了價格的積極貢獻。

This Medicaid rebate adjustment also negatively impacted Neupogen sales as they were down 9% year on year.

這一醫療補助回扣調整也對 Neupogen 的銷售額產生了負面影響，因為它們同比下降了 9%。

Today, we have only seen a slight impact from the new Filgrastim competition in both the US and Europe.

今天，我們只看到美國和歐洲新的 Filgrastim 競爭的輕微影響。

Turning now to Enbrel on slides 15 and 16.

現在轉到幻燈片 15 和 16 上的 Enbrel。

Underlying demand continues to be strong, as sales were up 7% year on year, primarily driven by price.

基本需求繼續強勁，銷售額同比增長 7%，主要受價格推動。

Most of the inventory dynamics we saw less quarter has worked its way through the channel.

我們看到較少季度的大部分庫存動態都通過渠道發揮作用。

At the end of quarter two, we did see a slight inventory build of about $60 million that we expect to be drawn down in quarter three.

在第二季度末，我們確實看到了約 6000 萬美元的輕微庫存增加，我們預計將在第三季度減少。

We continue to see strong segment growth in both rheumatology and dermatology at 19% and 21% respectively, and we held value share in both segments quarter on quarter, as shown on slide number 17.

我們繼續看到風濕病學和皮膚病學的細分市場分別以 19% 和 21% 的速度強勁增長，並且我們在這兩個細分市場中按季度持有價值份額，如幻燈片 17 所示。

Now to slide 18.

現在幻燈片 18。

Epogen sales were up 2% year on year, as price was partially offset by last year's Medicaid rebate adjustments.

Epogen 銷售額同比增長 2%，因為價格被去年的醫療補助回扣調整部分抵消。

Unit demand has been relatively stable and we continue to monitor average hemoglobin levels and dose utilization under the bundled payment system.

單位需求相對穩定，我們繼續監測捆綁支付系統下的平均血紅蛋白水平和劑量利用率。

Aranesp was down 1% year on year, as shown on slide 19.

Aranesp 同比下降 1%，如幻燈片 19 所示。

Underlying demand for Aranesp continues to decrease slightly, due to practice patterns in both oncology and nephrology in the US, and due to price competition pressures in Europe.

由於美國腫瘤學和腎髒病學的實踐模式以及歐洲的價格競爭壓力，對 Aranesp 的潛在需求繼續略有下降。

Turning now to slide 20, the combined Denosumab franchise grew 29% year on year, with a 31% unit growth.

現在轉到幻燈片 20，合併後的狄諾塞麥特許經營權同比增長 29%，單位增長 31%。

Prolia grew 40% year on year, due to strong unit demand, as we continue to grow share in all markets.

由於強勁的單位需求，Prolia 同比增長 40%，因為我們在所有市場中的份額繼續增長。

In the US, an improved salesforce focus on high-prescribing physicians continues to drive both depth and breadth of prescriptions.

在美國，銷售人員對高處方醫師的關注度有所提高，這繼續推動處方的深度和廣度。

In fact, new patient Rx's are up 33% year on year, and our DTC programs are driving increases in patient awareness and patient requests.

事實上，新患者 Rx 同比增長 33%，我們的 DTC 計劃正在推動患者意識和患者請求的增加。

As a result, in the US, we grew market share as measured by days of therapy by 3 percentage points in the quarter, up to 17% shown on slide 21.

因此，在美國，我們在本季度以治療天數衡量的市場份額增長了 3 個百分點，如幻燈片 21 所示高達 17%。

US repeat injection rates are over 60% on second injection, and over 70% on third injection, leading to a 50% increase in repeat patients versus a year ago.

美國第二次注射的重複注射率超過 60%，第三次注射的重複注射率超過 70%，導致重複患者與一年前相比增加了 50%。

XGEVA grew 20% year on year, due to strong unit demand.

由於單位需求強勁，XGEVA 同比增長 20%。

XGEVA continues to capture market share in a growing market, despite competition from generic zoledronic acid, as shown on slide number 22.

儘管來自非專利唑來膦酸的競爭，XGEVA 繼續在不斷增長的市場中佔據市場份額，如幻燈片編號 22 所示。

Our focus with prescribers on the superior clinical efficacy profile of XGEVA continues to drive growth.

我們與處方醫生對 XGEVA 卓越臨床療效的關注繼續推動增長。

Now to Sensipar, which continues to grow and is now annualizing at a run rate of about $1.2 billion.

現在是 Sensipar，它繼續增長，現在年化率約為 12 億美元。

As a result of increased patient penetration, quarter two sales grew 15% year on year, growth included both unit demand and price.

由於患者滲透率增加，第二季度銷售額同比增長 15%，增長包括單位需求和價格。

Nplate grew 12% year on year, mainly due to a high unit demand and strong market growth across all regions.

Nplate 同比增長 12%，這主要是由於所有地區的高單位需求和強勁的市場增長。

Vectibix sales grew 42% year on year, driven by strong unit demand across all regions.

在所有地區強勁的單位需求推動下，Vectibix 銷售額同比增長 42%。

Vectibix is now the only EGFR agent approved with improved overall survival data of first-line metastatic colorectal cancer in combination with an oxaliplatin-based regimen, or FOLFOX, in KRAS wild-type patients, and will address an important unmet need in these patients.

Vectibix 現在是唯一獲批的 EGFR 藥物，與基於奧沙利鉑的方案或 FOLFOX 聯合用於 KRAS 野生型患者，一線轉移性結直腸癌的總生存數據得到改善，並將解決這些患者未滿足的重要需求。

Finally, Kyprolis sales were up 15% globally and 23% in the US on a sequential basis.

最後，Kyprolis 的全球銷售額環比增長了 15%，在美國環比增長了 23%。

In the US, roughly half of this growth is due to unit demand and the other half due to return to normal inventory levels versus last quarter.

在美國，這一增長的大約一半是由於單位需求，另一半是由於與上一季度相比恢復到正常庫存水平。

Kyprolis continues to maintain dominant share in the third line multiple myeloma setting.

Kyprolis 繼續在三線多發性骨髓瘤治療中保持主導地位。

We expect the next major inflection point for Kyprolis will be upon the inclusion of second line data in the label.

我們預計 Kyprolis 的下一個主要轉折點將是在標籤中包含二線數據。

I look forward to reviewing the ASPIRE data in the near future.

我期待在不久的將來審查 ASPIRE 數據。

As we enter into the second half of the year, we've made very good progress on a number of fronts.

進入下半年，我們在很多方面都取得了很好的進展。

I will conclude my prepared comments where I began.

我將從我開始的地方結束我準備好的評論。

Our legacy products remain stable, despite new competition, and our growth phase products continue to benefit from higher demand and increased market share.

儘管有新的競爭，我們的傳統產品仍然保持穩定，我們的成長期產品繼續受益於更高的需求和增加的市場份額。

Now I'll pass it to Sean.

現在我將它傳遞給肖恩。

Thanks, Tony.

謝謝，托尼。

Good afternoon.

下午好。

We continue to advance our pipeline so let me begin with an update on cardiovascular programs, beginning with Evolocumab, our PCSK9 antibody.

我們繼續推進我們的管道，所以讓我從心血管項目的更新開始，從我們的 PCSK9 抗體 Evolocumab 開始。

We're busy preparing our Evolocumab submission for dyslipidemia, and are targeting submissions in the US and EU this quarter.

我們正忙於準備用於治療血脂異常的 Evolocumab 提交材料，目標是本季度在美國和歐盟提交的材料。

These submissions for Evolocumab will include both Q 2-week and Q monthly dosing, however, in order to maximize the probability of a first-cycle approval for Evolocumab delivered via our autoinjector, we've decided to not include our automated mini-doser device in the initial submission.

Evolocumab 的這些提交將包括 Q 2 周和 Q 每月給藥，但是，為了最大限度地提高通過我們的自動注射器交付的 Evolocumab 第一周期批准的可能性，我們決定不包括我們的自動迷你加藥器設備在最初的提交中。

Rather, the plan is to submit the device file as a supplement shortly after the initial approval of Evolocumab.

相反，計劃是在 Evolocumab 獲得初步批准後不久提交設備文件作為補充。

We also had the opportunity to present data from our Evolocumab Phase III TESLA study in homozygous familial hypercholesterolemia, and our Phase II/III TAUSSIG study in severe familial hypercholesterolemia at the European Atherosclerosis Society meeting last month.

在上個月的歐洲動脈粥樣硬化學會會議上，我們還有機會展示我們針對純合子家族性高膽固醇血症的 Evolocumab III 期 TESLA 研究和針對嚴重家族性高膽固醇血症的 II/III 期 TAUSSIG 研究的數據。

These data generated a lot of excitement, and we continue to explore the potential for Evolocumab in these severely-affected patient populations.

這些數據令人興奮不已，我們將繼續探索 Evolocumab 在這些受到嚴重影響的患者群體中的潛力。

In addition, we have completed our submission of Ivabradine in the US for chronic heart failure.

此外，我們已經在美國完成了用於治療慢性心力衰竭的伊伐布雷定的提交。

An epidemic condition with a high degree of unmet need, based on the large data set including outcomes data.

基於包括結果數據在內的大型數據集，具有高度未滿足需求的流行病。

We anticipate that the successful launch of Evolocumab and Ivabradine will meaningfully benefit many patients with cardiovascular risk.

我們預計 Evolocumab 和 Ivabradine 的成功上市將使許多有心血管風險的患者受益。

We are looking forward to new Kyprolis data, including a review by an independent data monitoring committee of an interim analysis of the ASPIRE study in relapsed multiple myeloma patients.

我們期待新的 Kyprolis 數據，包括獨立數據監測委員會對複發多發性骨髓瘤患者 ASPIRE 研究的中期分析的審查。

And the final analysis of the FOCUS study in relapsed refractory multiple myeloma.

以及對複發難治性多發性骨髓瘤的 FOCUS 研究的最終分析。

In both of these event-driven studies, our current estimates are that these analyses will occur in the third quarter.

在這兩項事件驅動的研究中，我們目前的估計是這些分析將在第三季度進行。

We've also completed enrollment in ENDEAVOR, our Phase III head-to-head comparison of Kyprolis with dexamethasone to Velcade with dexamethasone in relapsed multiple myeloma.

我們還完成了 ENDEAVOR 的註冊，這是我們在復發性多發性骨髓瘤中對 Kyprolis 與地塞米鬆與 Velcade 與地塞米鬆的 III 期頭對頭比較。

Our immunooncology programs continue to advance and we had several data presentations at ASCO.

我們的免疫腫瘤學計劃繼續推進，我們在 ASCO 上進行了多次數據展示。

We presented the overall survival data from our Phase III T-Vec study in metastatic melanoma, which demonstrated a 4.4 month improvement in overall survival, which closely approached statistical significance.

我們介紹了轉移性黑色素瘤 III 期 T-Vec 研究的總體生存數據，該數據表明總體生存期提高了 4.4 個月，接近統計學意義。

We believe this trend, along with the successful result on our durable response rate primary end point, makes for a very compelling data set, and we recently submitted a BLA for this agent in the US, and are planning a European submission in the third quarter for regionally and distantly metastatic melanoma.

我們相信這一趨勢，連同我們持久響應率主要終點的成功結果，構成了一個非常引人注目的數據集，我們最近在美國提交了該代理的 BLA，併計劃在第三季度提交歐洲提交用於區域和遠處轉移性黑色素瘤。

In addition, we continue to believe that there's a compelling opportunity for T-Vec to prime the immune system with checkpoint inhibitors.

此外，我們仍然相信，T-Vec 有一個令人信服的機會，可以用檢查點抑製劑啟動免疫系統。

We're currently investigating T-Vec in combination with ipilimumab, or Yervoy, in a phase IB/II metastatic melanoma study.

我們目前正在 IB/II 期轉移性黑色素瘤研究中研究 T-Vec 與 ipilimumab 或 Yervoy 的結合。

The phase IB portion was presented at ASCO, and while a small study, the encouraging response rate we reported, along with no new or unexpected toxicities, generated a lot of interest.

IB 階段部分在 ASCO 上展示，雖然這是一項小型研究，但我們報告的令人鼓舞的反應率以及沒有新的或意外的毒性引起了很多興趣。

We're also moving forward aggressively with our collaborative efforts with Merck on PD-1, and expect to begin combination studies later this year.

我們還積極推進與默克公司在 PD-1 方面的合作，並預計將在今年晚些時候開始聯合研究。

We also presented the blinatumomab confirmatory Phase II results in relapsed refractory adult acute lymphoblastic leukemia at ASCO.

我們還在 ASCO 上展示了 blinatumomab 對複發難治性成人急性淋巴細胞白血病的 II 期驗證結果。

We're preparing a submission in the US where we were granted breakthrough therapy designation this year and are also in discussions with regulators about our EU submission.

我們正在準備在美國提交一份報告，我們今年在美國獲得了突破性治療指定，並且還在與監管機構討論我們在歐盟提交的報告。

Our Phase II study of Vectibix versus Avastin in first-line wild-type KRAS metastatic colorectal cancer suggested a survival advantage from Vectibix in this population, which also garnered interest at ASCO.

我們在一線野生型 KRAS 轉移性結直腸癌中對 Vectibix 與 Avastin 進行的 II 期研究表明，Vectibix 在這一人群中具有生存優勢，這也引起了 ASCO 的興趣。

As you will recall, we recently received US approval for first-line use with FOLFOX in wild-type KRAS metastatic colorectal cancer.

正如您所記得的，我們最近獲得美國批准將 FOLFOX 用於野生型 KRAS 轉移性結直腸癌的一線治療。

Our accelerated approval for monotherapy in metastatic colorectal cancer was also converted to full approval at that time.

我們對轉移性結直腸癌單藥治療的加速批准也在當時轉換為完全批准。

Regarding the ongoing Trebananib Phase III study in recurring ovarian cancer, our latest estimates from the results of this event-driven overall survival secondary endpoint is now the fourth quarter this year.

關於正在進行的針對複發性卵巢癌的 Trebananib III 期研究，我們根據這一事件驅動的總體生存次要終點結果的最新估計現在是今年第四季度。

Recall that Trebananib is a peptibody that inhibits ANG one and two, and the primary endpoint of progression free survival was met last year.

回想一下，Trebananib 是一種抑制 ANG 1 和 2 的肽體，去年達到了無進展生存期的主要終點。

Our psoriasis program for brodalumab, which we're developing with our partners at AstraZeneca, consists of three Phase III studies, one placebo-controlled and two head-to-head studies comparing to ustekinumab, or Stelara.

我們正在與阿斯利康合作夥伴共同開發的 brodalumab 銀屑病項目包括三項 III 期研究、一項安慰劑對照研究和兩項與 ustekinumab 或 Stelara 進行比較的頭對頭研究。

The efficacy data we reported from the placebo-controlled study was very positive and the other two studies we'll read out in the fourth quarter.

我們從安慰劑對照研究中報告的療效數據非常積極，我們將在第四季度宣讀另外兩項研究。

The results from our Phase II study in psoriatic arthritis with brodalumab were recently published in the New England Journal of Medicine.

我們使用 brodalumab 治療銀屑病關節炎的 II 期研究結果最近發表在《新英格蘭醫學雜誌》上。

And, as we have announced, we and our partners have initiated two Phase III studies in the psoriatic arthritis to evaluate the impact of brodalumab on improving clinical signs and symptoms as well as the ability to prevent joint damage.

而且，正如我們所宣布的，我們和我們的合作夥伴已經啟動了兩項針對銀屑病關節炎的 III 期研究，以評估 brodalumab 對改善臨床體徵和症狀以及預防關節損傷的能力的影響。

As you heard from us earlier this month, AMG 416, the intravenous calcimimetic we gained access to via the acquisition of KAI Pharmaceuticals had a very positive top-line result from the first of three Phase III studies in secondary hyperparathyroidism.

正如您本月早些時候從我們那裡聽到的那樣，AMG 416 是我們通過收購 KAI Pharmaceuticals 獲得的靜脈內擬鈣劑，在繼發性甲狀旁腺功能亢進症的三項 III 期研究中的第一項取得了非常積極的頂線結果。

We look forward to seeing the second placebo-controlled study in the third quarter, as well as the result of the head-to-head comparisons to Sensipar in the first half of next year.

我們期待在第三季度看到第二項安慰劑對照研究，以及明年上半年與 Sensipar 的直接比較結果。

Secondary hyperparathyroidism can be a challenging disease to manage, and we believe there's an important role for an effective calcimimetic that can be administered intravenously, coincident with hemodialysis.

繼發性甲狀旁腺功能亢進症可能是一種難以控制的疾病，我們相信一種有效的擬鈣劑具有重要作用，它可以與血液透析同時靜脈內給藥。

Turning to a couple of our earlier stage programs, we were pleased to see Phase I asthma data from our anti-TSLP, or thymic stromal lymphopoietin monoclonal antibody AMG 157 also highlighted in the New England Journal recently.

談到我們的幾個早期項目，我們很高興看到我們的抗 TSLP 或胸腺基質淋巴細胞生成素單克隆抗體 AMG 157 的 I 期哮喘數據最近也在新英格蘭雜誌上得到了強調。

We're developing this molecule in partnership with AstraZeneca/ MedImmune, and believe this program has the potential to help address the large unmet need in asthma.

我們正在與 AstraZeneca/MedImmune 合作開發這種分子，並相信該項目有可能幫助解決哮喘方面大量未滿足的需求。

As a quick update on our CGRP receptor antibody, AMG 334, we've completed enrollment in our Phase IIB dose ranging study in episodic migraine patients, and expect to see these data later this year.

作為對我們的 CGRP 受體抗體 AMG 334 的快速更新，我們已經完成了對發作性偏頭痛患者進行的 IIB 期劑量範圍研究的招募，並希望在今年晚些時候看到這些數據。

Our Phase IIB chronic migraine study with AMG 334 continues to enroll.

我們使用 AMG 334 進行的 IIB 期慢性偏頭痛研究仍在招募中。

Finally, I'd like to take a moment to thank my Amgen colleagues for our continued progress toward advancing these new potential medicines for patients in need.

最後，我想花點時間感謝我的 Amgen 同事，感謝我們在為有需要的患者開發這些新的潛在藥物方面取得的持續進展。

Bob.

鮑勃。

Okay.

好的。

Thank you, Sean.

謝謝你，肖恩。

Before turning to questions, let me just take a moment to put the many parts of our business into a single perspective as we move along the strategic path that we first outlined for you in 2011.

在轉向問題之前，讓我花點時間將我們業務的許多部分放在一個單一的角度來看，因為我們沿著我們在 2011 年首次為您概述的戰略路徑前進。

First we're focused on bringing forward a substantial portfolio of innovative molecules that address significant unmet medical needs in areas of grievous illness.

首先，我們專注於提出大量創新分子組合，以解決嚴重疾病領域未滿足的重大醫療需求。

Molecules that demonstrate large, clinically relevant effects and are supported where possible by human genetic validation.

分子表現出巨大的臨床相關作用，並在可能的情況下得到人類遺傳驗證的支持。

Second, we're building our business infrastructure to bring medicines to patients all around the world, shifting resources to areas of highest value and growth.

其次，我們正在建設我們的業務基礎設施，為世界各地的患者提供藥品，將資源轉移到價值最高和增長最快的領域。

And finally, we're making these investments for growth as we continue to meet our commitments to grow revenues and earnings and return capital to our shareholders.

最後，隨著我們繼續履行增加收入和收益以及向股東返還資本的承諾，我們正在進行這些投資以實現增長。

And we look forward to providing more granularity on our progressing pipeline, our commercial plans for launching new products, our expansion activities, and so forth when we're together for the business review meeting during the fourth quarter.

當我們一起參加第四季度的業務審查會議時，我們期待提供更多關於我們正在進行的管道、我們推出新產品的商業計劃、我們的擴張活動等的詳細信息。

So with that, let's turn to the question and answer session, and Marvin perhaps you can remind our callers of the procedure that we follow.

因此，讓我們轉到問答環節，馬文或許可以提醒我們的來電者我們遵循的程序。

(Operator Instructions)

（操作員說明）

Matthew Harrison, Morgan Stanley.

摩根士丹利的馬修哈里森。

Hey good afternoon everybody, thanks for taking the question.

大家下午好，謝謝你提出這個問題。

I wanted to ask specifically about the restructuring and what you indicated was potentially its impact on the guidance for this year.

我想具體詢問有關重組的問題，以及您指出的重組對今年指導的潛在影響。

If I go and I look for you at the low-end had about a $0.30 improvement in EPS, and at the high end you bumped by $0.20.

如果我去尋找你，在低端，每股收益提高了大約 0.30 美元，而在高端，你提高了 0.20 美元。

And if I take a look at that based upon your margin structure that you didn't change in your guidance, it looks like on an annualized basis that's around $30 million to about $165 million.

如果我根據你的利潤率結構看一下你沒有改變你的指導，它看起來像在年化基礎上大約在 3000 萬美元到大約 1.65 億美元之間。

Is that -- of that $700 million, is that what you expect will actually fall through to the bottom line and the rest is in terms of increased R&D or SG&A expense to launch these new products?

那是——在這 7 億美元中，你所期望的實際上會落到底線，其餘的是增加研發或 SG&A 費用來推出這些新產品嗎？

Thanks

謝謝

Thanks for the question Matt.

感謝馬特的提問。

I guess a couple things perhaps to help you think through the modeling.

我想可能有幾件事可以幫助您思考建模。

First, as I said in my remarks the restructuring announcement that we made today was contemplated when we gave initial 2014 guidance, so I wouldn't expect that you'd be adjusting your 2014 guidance as a result of today's announcement, because as I said we had these in mind when we provided 2014 guidance.

首先，正如我在發言中所說，我們在提供 2014 年初步指導時就考慮了今天發布的重組公告，因此我不認為您會因為今天的公告而調整 2014 年的指導，因為正如我所說我們在提供 2014 年指南時考慮到了這些。

And I'd just reiterate what David said which is bear in mind that it's typical for our second-quarter operating margin to be the highest for us of the year, and we expect that there will be some increase in operating expenses as normal in the third and fourth quarter, and perhaps a little bit more the usual as we begin investing in the prelaunch activities for the medicines that we file.

我只是重申大衛所說的話，請記住，我們第二季度的營業利潤率通常是我們今年最高的，我們預計營業費用會像往常一樣增加一些第三和第四季度，也許會比往常多一點，因為我們開始投資於我們提交的藥物的上市前活動。

Robyn Karnauskas, Deutsche Bank

Robyn Karnauskas，德意志銀行

Great, this is Mohit for Robyn.

太好了，這是 Robyn 的 Mohit。

Thanks for taking my question.

感謝您提出我的問題。

I have one question regarding AMG 416 regarding the head-to-head study you are doing with comparing to Sensipar.

我有一個關於 AMG 416 的問題，關於您正在進行的與 Sensipar 比較的頭對頭研究。

What do you expect to see from this trial apart from the primary endpoint?

除了主要終點之外，您希望從該試驗中看到什麼？

Which other second hand endpoint we should look at as well, and then do you expect to conduct an outcome study for this product also?

我們還應該查看哪個其他二手終點，然後您是否希望對該產品進行結果研究？

Thank you.

謝謝你。

Sure.

當然。

I would say that the comparison to Sensipar is important because we need to understand both an efficacy, a tolerability, and an adherence over time how the products compare.

我想說與 Sensipar 的比較很重要，因為我們需要了解產品的功效、耐受性和隨時間推移的依從性如何比較。

And I think all of those are important just understanding the sort of biochemical activity of the dosing that we've chosen for AMG 416 versus the current Sensipar dosing.

我認為所有這些都很重要，只要了解我們為 AMG 416 選擇的劑量與當前 Sensipar 劑量的生化活性。

Understanding the tolerability issues, which as you know are quite limiting for Sensipar given the large pill burden that these dialysis patients face.

了解耐受性問題，正如您所知，考慮到這些透析患者面臨的大量藥物負擔，這對 Sensipar 來說是非常有限的。

And finally, the adherence issue, which of course is related to tolerability but not directly.

最後，依從性問題，這當然與耐受性有關但不直接相關。

So these are all the things that we'd be looking at to try to understand where AMG 416 should be positioned to help patients and physicians manage the issues associated with these patients.

因此，這些都是我們要研究的所有內容，以試圖了解 AMG 416 應該定位在哪裡，以幫助患者和醫生管理與這些患者相關的問題。

Great, thanks.

太謝謝了。

Eric Schmidt, Cowen and Company

埃里克·施密特考恩公司

Thanks for taking the question.

感謝您提出問題。

Maybe for Bob on the restructuring I guess I understand that you don't want to be too specific until the business review meeting, but should we generally take it to mean that you're redeploying investment in R&D toward SG&A?

也許對於 Bob 的重組，我想我知道你不想在業務審查會議之前說得太具體，但我們是否應該普遍認為這意味著你正在將研發投資重新部署到 SG&A？

And if that's the case do you think you can bring Amgen's targeted R&D down to more in line with your large biopharma peers?

如果是這樣的話，您認為您可以將 Amgen 的目標研發降低到與您的大型生物製藥同行更一致的水平嗎？

Thanks for the question Eric.

感謝埃里克的提問。

Let me make clear that the changes that we announced today are Company-wide changes, so while the facilities particular in Washington and to an extent in Colorado that we're closing are primarily research and development and process development related, that the cuts themselves are Company-wide and some of the launch investments will relate to research and development activities, and obviously the bulk of it over time to commercial activities.

讓我澄清一下，我們今天宣布的變化是全公司範圍內的變化，因此雖然我們關閉的位於華盛頓和一定程度上位於科羅拉多州的設施主要與研發和流程開發相關，但削減本身是全公司範圍內的一些啟動投資將與研發活動有關，隨著時間的推移，顯然其中大部分將與商業活動有關。

So we're reallocating away from some of our lower growth, lower return areas and to what we expect to be higher growth, higher return opportunities for us, so that's how I'd characterize it.

因此，我們正在重新分配一些增長較低、回報較低的領域，轉向我們期望增長較高、回報機會較高的領域，這就是我的描述方式。

And you're right Eric that in the context of our full business review, we'll be able to expend enough time to elaborate on how we expect the cost structure to evolve as we reshape the business.

埃里克，你是對的，在我們全面業務審查的背景下，我們將能夠花費足夠的時間來詳細說明我們期望成本結構如何隨著我們重塑業務而演變。

Terence Flynn, Goldman Sachs.

特倫斯弗林，高盛。

Hi, thanks for taking the question.

您好，感謝您提出問題。

Was just wondering if there are any new pieces of clinical data that you're expecting that might change the level of reinvestment either up or down as you cited in your restructuring?

只是想知道您是否期望有任何新的臨床數據可能會像您在重組中引用的那樣改變再投資水平？

And then another question Bob is in your prepared remarks you mentioned the well-designed ASPIRE trial; I was wondering if you care to expand here as we fielded a number of questions on some of the limitations of the trial design, and just wondering if you could help us out there.

然後另一個問題 Bob 在你準備好的評論中提到了精心設計的 ASPIRE 試驗；我想知道你是否願意在這裡擴展，因為我們就試驗設計的一些局限性提出了一些問題，只是想知道你是否可以幫助我們。

Thank you

謝謝

Sure.

當然。

I would perhaps take your question in two pieces.

我也許會把你的問題分成兩部分。

Why don't I take the first part and then Sean can elaborate on the R&D question and the ASPIRE question in particular.

為什麼我不參加第一部分，然後 Sean 可以詳細說明研發問題，特別是 ASPIRE 問題。

Our expectation again is that the reception to our Evolocumab data has been very positive, so we look forward to continuing to advance that and to begin investing in the kinds of activities that would be typical before the launch of such a medicine.

我們再次期望 Evolocumab 數據的接受度非常積極，因此我們期待繼續推進這一點，並開始投資此類藥物推出前的典型活動。

In addition we shared incremental information with you on this call about our other cardiovascular medicine, Ivabradine, and Sean I think was pretty clear about the steps that we're taking with our oncology medicines and AMG 416.

此外，我們在這次電話會議上與您分享了關於我們的其他心血管藥物伊伐布雷定和肖恩的增量信息，我認為肖恩非常清楚我們在腫瘤藥物和 AMG 416 上採取的步驟。

So on the basis of those molecules and the progress we've made against them, we feel it's time now to reallocate resources and that's what we're preparing to do.

因此，基於這些分子以及我們在對抗它們方面取得的進展，我們認為現在是重新分配資源的時候了，這就是我們正準備做的事情。

Sean if you want to elaborate on any of the specific incremental programs that we embarked on or talk about ASPIRE?

肖恩，如果你想詳細說明我們開始或談論 ASPIRE 的任何具體增量計劃？

Of course fundamentally we look at each of the clinical trial results that we get on major late-stage programs and the emerging pipeline as well, and make investment decisions accordingly, so that's kind of the name of the game.

當然，從根本上說，我們會查看我們在主要後期項目和新興管道中獲得的每一個臨床試驗結果，並據此做出投資決策，這就是遊戲的名稱。

It's a little bit hard to anticipate.

有點難以預料。

You can get disappointed and invest less, and you can things can look better than you think and you invest more, so I don't know how else to address that.

你可能會感到失望而減少投資，也可能事情看起來比你想像的要好，你會投入更多，所以我不知道還有什麼辦法可以解決這個問題。

In terms of ASPIRE, I think that Bob is reflecting the sense that the R&D organization has about the ASPIRE study in general terms, which is that I would agree entirely and do agree that the study is well designed.

就 ASPIRE 而言，我認為 Bob 反映了研發組織對 ASPIRE 研究的一般看法，即我完全同意並且確實同意該研究設計良好。

It is always possible to criticize study designs and many different ways to design studies for the same basic objectives.

總是可以批評研究設計和許多不同的方法來為相同的基本目標設計研究。

Obviously, ASPIRE is designed to help us to understand the incremental benefit that occurs by adding Kyprolis to a rev-dex standard of care background in this population.

顯然，ASPIRE 旨在幫助我們了解通過將 Kyprolis 添加到該人群的 rev-dex 護理背景標準中而產生的增量收益。

So I think likely if there are real specific questions around the study design so that we can talk about that offline, but I would agree that it's a well --

所以我認為，如果研究設計存在真正的具體問題，那麼我們可以離線討論，但我同意這是一個很好的——

It's a large study.

這是一項大型研究。

It's an 800 patient study and I think we expect it to provide a pretty good window into the truth about the molecules, I think that's what I would expect from a well-designed study.

這是一項 800 名患者的研究，我認為我們希望它能為了解分子真相提供一個很好的窗口，我認為這是我對精心設計的研究的期望。

Geoffrey Porges, Bernstein

杰弗裡·波赫斯，伯恩斯坦

Thank you very much for taking the question.

非常感謝你接受這個問題。

I hate to come back to this Bob, but I'm still confused about the effects of the restructuring.

我不想回到這個鮑勃身上，但我仍然對重組的影響感到困惑。

Could I ask you are you suggesting to us that the operating expenses net will be flat in 2015 and 2016?

請問您是在向我們建議 2015 年和 2016 年的營業費用淨額持平嗎？

Because you will take R&D down and SG&A will go up to prepare for these cardiovascular launches?

因為您將減少研發並增加 SG&A 來為這些心血管產品的發布做準備？

Or are you suggesting that the operating expense ratio will be constant in 2015 through 2016 with that same reallocation?

或者您是否建議在 2015 年至 2016 年通過相同的重新分配，運營費用比率將保持不變？

I'm trying to understand what it means.

我試圖理解這意味著什麼。

Thanks Geoff.

謝謝杰夫。

What we were trying to convey is that the changes that we've announced in this for step of restructuring would aggregate to $700 million of operating expense when compared to 2013, so the things that we are eliminating for example where $700 million of operating expense in 2013.

我們試圖傳達的是，與 2013 年相比，我們在此重組步驟中宣布的變化總計將達到 7 億美元的運營費用，因此我們正在消除的事情例如其中 7 億美元的運營費用2013.

Now what we're planning to do is to reallocate much of that to the activities associated with the molecules that we've begun filing.

現在我們計劃做的是將其中大部分重新分配給與我們已經開始提交的分子相關的活動。

So you're right that what we're saying is first in 2014 we had contemplated these actions and they've taken place late in the calendar year, so this doesn't really affect the outlook for 2014.

所以你是對的，我們所說的是我們在 2014 年首先考慮了這些行動，並且它們發生在日曆年的晚些時候，所以這並沒有真正影響 2014 年的前景。

With respect to 2015, again, the actions will begin to accrue benefits for us through the course of the year, and by 2016 we think we will be through the actions that we've disclosed.

關於 2015 年，這些行動將在這一年中開始為我們帶來收益，到 2016 年，我們認為我們將通過我們所披露的行動。

And so the full benefit of these actions would be available, therefore, we'll have on order of magnitude $700 million in that year, some portion of which -- most of which we expect to invest in launch activities for the molecules that we're filing.

因此，這些行動的全部好處將是可用的，因此，我們在那一年將有大約 7 億美元的數量級，其中的一部分——我們預計其中的大部分將投資於我們“重新備案。

So assuming those activities continue to proceed as we expect them to, we would plan to reinvest most of that in the business Geoff, in that year.

因此，假設這些活動繼續按照我們的預期進行，我們將計劃在那一年將其中的大部分再投資於 Geoff 業務。

Now one of other thing just to reiterate, again the restructuring that we've announced is Company-wide, so we're reallocating resources away not just from research and development but from across the business.

現在要重申的另一件事是，我們宣布的重組是在全公司範圍內進行的，因此我們不僅要重新分配研發資源，還要重新分配整個業務部門的資源。

Okay.

好的。

Thank you.

謝謝你。

Josh Schimmer, Piper Jaffray

喬什·席默，派珀·杰弗瑞

Thanks for taking the question.

感謝您提出問題。

I guess on a high level or conceptual basis as we think about 2015 and 2016, do we think of these as transition years between the mature franchise and the emerging pipeline?

我想在我們考慮 2015 年和 2016 年時，在高層次或概念基礎上，我們是否認為這些是成熟特許經營和新興管道之間的過渡年？

Or are you confident you can still deliver meaningful EPS growth over that time?

或者您是否有信心在此期間仍能實現有意義的 EPS 增長？

Thanks.

謝謝。

As I said in my remarks our objective is to continue to grow the business and to continue to increase our returns for shareholders, including to increase our dividend during this period.

正如我在發言中所說，我們的目標是繼續發展業務並繼續增加股東回報，包括在此期間增加股息。

So that's our objective Josh, and this restructuring doesn't reflect any change to that.

所以這就是我們的目標 Josh，這次重組並未反映出任何變化。

Okay.

好的。

Thanks.

謝謝。

Yaron Werber, Citi.

Yaron Werber，花旗銀行。

Hi, thanks for taking my question.

嗨，謝謝你提出我的問題。

If you don't mind it's sort of two quick ones.

如果你不介意，那就是兩個快速的。

One, just for you Bob, when you look at Amgen, historically Amgen has had really a great franchise and very much monopoly-dominant positions.

一，只為你鮑勃，當你看看安進公司時，從歷史上看，安進公司確實擁有很好的特許經營權和非常壟斷的主導地位。

This Company historically has not had to compete in a lot of markets maybe outside of inflammation.

這家公司歷來不必在很多市場上競爭，也許在炎症之外。

The markets you're going to go into are going to be a lot more competitive, and I just want to understand how you position the Company for that?

您將要進入的市場將更具競爭力，我只想了解您如何為公司定位？

And then secondly, if you don't mind just Evolocumab, the decision to sort of split up the two formulations, what was the reason for that, the filing for the two formulations?

然後其次，如果你不介意 Evolocumab，決定將兩種製劑分開，那是什麼原因，兩種製劑的備案？

Thank you.

謝謝你。

Okay.

好的。

So two questions there.

所以有兩個問題。

Why don't I take the first part of the competitive dynamic, and I'll ask Tony to add his thoughts, and then Sean can reiterate his comments on Evolocumab.

為什麼我不參加競爭動態的第一部分，我會請託尼補充他的想法，然後肖恩可以重申他對 Evolocumab 的評論。

But Yaron, you're right we're entering a new era in the sense that we're entering into more competitive spaces than we have in the past, and that's something we've been talking about here at Amgen over the course of the last couple years.

但是 Yaron，你是對的，我們正在進入一個新時代，因為我們正在進入比過去更具競爭力的領域，這就是我們在 Amgen 的整個過程中一直在談論的事情過去幾年。

And we're excited and looking forward to have the opportunity to show what we can do in competing in some of these competitively-intense fields that we're entering.

我們很高興並期待有機會展示我們在我們正在進入的一些競爭激烈的領域中的競爭能力。

And again, we think we're entering these spaces with molecules that have large effect size, which are differentiated which form the basis of a clear approach for our developing these new product areas.

再一次，我們認為我們正在使用具有大效應大小的分子進入這些空間，這些分子是有區別的，這構成了我們開發這些新產品領域的明確方法的基礎。

Tony why don't you share your thoughts?

托尼，你為什麼不分享你的想法？

So you're right that initially Amgen specialized in building markets as they did with both Filgrastim and ESA franchises, but as you look back at the legacy portfolio now where our European team have been defending against a number of competitors in the market during the last seven years, we truly have built a competitive skill and ability.

所以你是對的，最初 Amgen 專注於建立市場，就像他們在 Filgrastim 和 ESA 特許經營權上所做的那樣，但是當你回顧現在的遺留產品組合時，我們的歐洲團隊在過去的幾年中一直在抵禦市場上的許多競爭對手七年來，我們真正打造了具有競爭力的本領和能力。

When we look at Enbrel in the US we compete on a daily basis against at least nine other competitors.

當我們審視美國的 Enbrel 時，我們每天都在與至少九個其他競爭對手競爭。

And when we launched Denosumab, we went in to launch against a branded Zometa, which became generic, had six competitors, and we still grow market share against those.

當我們推出 Denosumab 時，我們開始針對品牌 Zometa 推出，該品牌已成為仿製藥，有六個競爭對手，我們仍然在增加市場份額。

So I think we have built a skill over time to really be competitive, and this is what we're honing with the team now as we go into new therapeutic areas, building therapeutic confidence, understanding of these relationships, and assuring that we can be maximally competitive as we go to market.

因此，我認為隨著時間的推移，我們已經建立了一種真正具有競爭力的技能，這就是我們在進入新的治療領域、建立治療信心、理解這些關係並確保我們能夠成為在我們進入市場時具有最大的競爭力。

Let me clarify on the issue around the Evolocumab device, so this is not a formulation issue.

讓我澄清一下圍繞 Evolocumab 設備的問題，所以這不是配方問題。

The formulation is a formulation that's going to be registered along with the every-two week and every-month dosing data.

該配方是一種將與每兩周和每月的劑量數據一起註冊的配方。

The autoinjector, which is the SureClick autoinjector, which we have many, many patient years of exposure and the regulators are very familiar will also be registered.

自動注射器，即 SureClick 自動注射器，我們有很多很多患者多年的經驗，監管機構非常熟悉，也將註冊。

What we're not initially registering is the automated mini-doser device, which administers the entire volume necessary for monthly injection as a single infusion.

我們最初沒有註冊的是自動微型劑量器設備，它可以將每月注射所需的全部體積作為單次輸液進行管理。

And the reason for that is to not take a chance given the novelty of that device as compared to our autoinjector of delaying the entire drug submission by including that, rather than getting it approved, get the autoinjector approved, get the product ready for launch, and then submit shortly after approval the device, which will be reviewed on a device clock, not a drug review clock.

這樣做的原因是不要冒險，因為與我們的自動注射器相比，該設備的新穎性包括延遲整個藥物提交，而不是獲得批准，讓自動注射器獲得批准，讓產品準備好發布，然後在批准後不久提交設備，這將在設備時鐘上進行審查，而不是藥物審查時鐘。

Mark Schoenebaum, ISI Group

Mark Schoenebaum，ISI 集團

Hey guys.

大家好。

In all seriousness thank you for the slide deck, and Arvind I will be featuring my Arvind Sood bobble head doll this week on my video, just so you know.

非常感謝您提供的幻燈片，Arvind 本週我將在我的視頻中展示我的 Arvind Sood 搖頭娃娃，只是讓您知道。

But I had a question for Bob, and then a quick clarification.

但我有一個問題要問鮑勃，然後是一個快速的澄清。

There's been a lot of activity in the large pharma and specialty pharma space, which you guys kind of straddle that with biotech on the inversion front, and I know your tax rate is very low, but much of your cash is generated ex-US and getting access to it is maybe a bit more complicated under ideal situation, so the former and well-known banker, I'd love to just know how you're thinking about inversions in general and whether or not Amgen might be interested in something like that, whether it makes sense or not.

大型製藥和專業製藥領域有很多活動，你們在反轉方面有點跨越生物技術，我知道你們的稅率很低，但你們的大部分現金是在美國以外產生的在理想情況下訪問它可能會有點複雜，所以這位前知名銀行家，我很想知道你是如何看待一般的倒置的，以及 Amgen 是否可能對類似的東西感興趣那，不管它是否有意義。

And just a quick clarification for Tony, Tony there's a lot going on with inventory this quarter, but I want to be very clear; if one looks at the data on a year-on-year comparison the increase in inventory year on year was negligible and you remain within the normal range, correct?

快速向托尼澄清一下，托尼本季度庫存有很多變化，但我想說得非常清楚；如果看同比數據，庫存同比增長可以忽略不計，屬於正常範圍，對嗎？

Just get that one first.

先拿那個吧。

Go ahead Tony.

繼續托尼。

So the answer is we ended the quarter within our normal range, the only exception being Enbrel, there was about $60 million over the normal range sequentially.

所以答案是我們在正常範圍內結束了本季度，唯一的例外是 Enbrel，連續超過正常範圍約 6000 萬美元。

And on a year-on-year basis the build was very, very modest, correct?

與去年同期相比，構建非常非常適中，對嗎？

Correct, yes.

正確，是的。

Thank you.

謝謝你。

So Mark, on your question, you're right, there's an awful lot of activity at the moment related to tax structuring.

所以馬克，關於你的問題，你是對的，目前有很多與稅收結構相關的活動。

I guess the first thing I observe is that our focus strategically is to try to advance molecules that we think we can add value to that address grievous illness, so that's where our energy is focused from a business development and capital allocation standpoint when we think outside of our own four walls.

我想我觀察到的第一件事是，我們的戰略重點是嘗試推進我們認為可以為解決嚴重疾病增加價值的分子，因此當我們從外部思考時，從業務發展和資本配置的角度來看，這就是我們的精力集中的地方我們自己的四堵牆。

I think my take on the inversion activity is that unfortunately our country doesn't yet have a globally competitive corporate tax system or structure, and until that changes I think there will be tax financial engineering related transactions like those that we're seeing now.

我認為我對倒置活動的看法是，不幸的是，我們的國家還沒有具有全球競爭力的公司稅收制度或結構，在這種變化之前，我認為會有像我們現在看到的那些與稅收金融工程相關的交易。

I hope that congress will take action and enact broad sweeping corporate tax reform, but I'm not optimistic that that will happen.

我希望國會採取行動並實施廣泛的公司稅改革，但我對這會發生並不樂觀。

Certainly not this year, and again I hope that even if corporate tax reform doesn't happen, that there may be a window for repatriation.

今年肯定不會，我再次希望，即使公司稅改革沒有發生，也可能有一個匯回的窗口。

But I think those two steps, corporate tax reform and repatriation, are important in order to create a level playing field for corporations, particularly like ours in innovative industries, and I think that's what you see in biotechnology and pharmaceutical activity right now.

但我認為這兩個步驟，公司稅改革和匯回，對於為公司創造一個公平的競爭環境很重要，特別是像我們在創新行業的公司，我認為這就是你現在在生物技術和製藥活動中看到的。

Michael Yee, RBC Capital Markets.

Michael Yee，RBC 資本市場。

Thanks.

謝謝。

Just maybe a question for Sean going back to some of the Kyprolis data, which is coming up.

也許 Sean 有一個問題要回到即將出現的一些 Kyprolis 數據。

Maybe you could clarify for us, I know there's multiple interims, I just wanted to clarify is this a 50% or 75% interim?

也許你可以為我們澄清一下，我知道有多個過渡期，我只是想澄清一下這是 50% 還是 75% 的過渡期？

Since prior did not stop and should we have full expectation that this one would stop since you're so positive on the overall design?

既然之前沒有停止，我們是否應該完全期望這個會停止，因為你對整體設計如此積極？

And then secondly, when this data comes out what do you think is clinically meaningful here in the second line, understanding it should be positive but what would you be very pleased with?

其次，當這些數據出現時，您認為第二行的臨床意義是什麼，理解它應該是積極的，但您會對什麼感到非常滿意？

So this particular interim on ASPIRE comes up with a reasonable number of events and power.

因此，ASPIRE 上的這個特殊過渡帶來了合理數量的事件和權力。

It's not of course fully powered as a final analysis would be.

它當然不像最終分析那樣完全強大。

And whether the study is well-designed or not has in my view nothing to do with the question of whether the results are going to be positive in an interim.

在我看來，這項研究是否設計良好與過渡期間結果是否會是積極的問題無關。

It's a question of the statistical power that you have to detect the effect size.

這是一個你必須檢測效果大小的統計能力的問題。

So depending on whether you're very ambitious in your thinking about an effect size for the molecule on top of Rev dex, you might imagine a positive interim at this stage.

因此，根據您在 Rev dex 之上考慮分子的效應大小是否非常雄心勃勃，您可能會在這個階段想像一個積極的過渡期。

If you're more conservative about the effect size you could imagine the study might have to run through to completion to show that effect size.

如果您對效應量較為保守，您可以想像該研究可能必須運行到完成才能顯示該效應量。

I hate to blurt out a number because I've had so many conversations with so many experts in this field, and I've heard such a large range of answers from people about what they think would be meaningful.

我討厭脫口而出一個數字，因為我已經與該領域的眾多專家進行了多次對話，而且我從人們那裡聽到瞭如此多的關於他們認為有意義的答案。

And largely it's because they're doing some kind of back of the envelope comparison in their minds to what one might see in such an experiment with Velcade, and this is not a Velcade comparison study; that study just enrolled fully, ENDEAVOR, and will come later.

這在很大程度上是因為他們在腦海中進行了某種粗略的比較，與人們在 Velcade 的此類實驗中可能看到的結果進行比較，這不是 Velcade 比較研究；該研究剛剛完全註冊，ENDEAVOR，稍後會進行。

We're going to see the data very soon.

我們很快就會看到數據。

And I think I'm just going to look at the data when it comes and we'll figure out and work with our -- we have access to most of the really key opinion leaders in this disease realm of the world.

而且我想我會在數據到來時查看數據，我們會弄清楚並與我們合作——我們可以接觸到世界上這個疾病領域中大多數真正關鍵的意見領袖。

And we'll have them help us understand how they feel about the results assuming that we do get a readout because the study stopped early for efficacy.

我們會讓他們幫助我們了解他們對結果的看法，假設我們確實得到了讀數，因為研究因療效而提前停止。

That may or may not occur at this data set we review.

這可能會也可能不會發生在我們審查的這個數據集中。

Okay.

好的。

Thank you.

謝謝你。

That's helpful.

這很有幫助。

Geoff Meacham, JPMorgan

Geoff Meacham，摩根大通

Hey guys, congrats on the quarter and thanks for taking my question.

大家好，祝賀本季度，感謝您提出我的問題。

First question, what can you tell us about the pace of commercial investments in Evolocumab, especially given the earlier filing?

第一個問題，關於 Evolocumab 的商業投資步伐，您能告訴我們什麼，尤其是考慮到較早的申請？

And then on the restructuring for the facilities footprint, is this mostly for legacy products, does this change your view on the biosimilar opportunity or other let's say more legacy kind of assets in terms of the revenue?

然後關於設施足蹟的重組，這主要是針對遺留產品，這是否會改變您對生物仿製藥機會或其他讓我們說更多遺留資產在收入方面的看法？

Sorry Geoff, I know you asked two questions there and I got the first one clearly.

抱歉，傑夫，我知道你問了兩個問題，我清楚地知道了第一個問題。

Let me ask Tony to respond to the first question.

讓我請託尼回答第一個問題。

You recognize of course that this is a competitive space, so I'm sure we're not going to say whole lot there, but let's come back Marvin and let Geoff ask the second question; I didn't catch the beginning few words of your sentence in the second question Geoff.

你當然知道這是一個競爭激烈的領域，所以我相信我們不會在那裡說太多，但讓我們回到 Marvin，讓 Geoff 問第二個問題；在第二個問題 Geoff 中，我沒聽清你句子的開頭幾個字。

As Sean said earlier we've filed now for Ivabradine, the drug for chronic heart failure, which obviously will be a critical part to Amgen moving into the cardiovascular space.

正如 Sean 早些時候所說，我們現在已經提交了 Ivabradine 的申請，這是一種治療慢性心力衰竭的藥物，這顯然將成為 Amgen 進軍心血管領域的關鍵部分。

Clearly that's where we'll be potentially approved sometime early next year, and we're setting up the commercial launch to ready ourselves for that.

顯然，這就是我們可能在明年初某個時候獲得批准的地方，我們正在準備商業發布，為此做好準備。

That team of specialists plus the medical organization will be the same organization that then takes Evolocumab to market a bit later during 2015.

該專家團隊加上醫療組織將在 2015 年晚些時候將 Evolocumab 推向市場。

Got you.

明白了

The second one and thanks Bob, Bob just on the restructuring with the lower facilities footprint I'm assuming this is mostly for legacy products but does it change your view on the biosimilar opportunity or the revenue potential for that or for any of your legacy products?

第二個，感謝 Bob，Bob 只是在重組，減少設施足跡，我假設這主要是針對遺留產品，但這是否會改變您對生物仿製藥機會或該產品或您的任何遺留產品的收入潛力的看法？

Okay, thanks for asking that question.

好的，謝謝你提出這個問題。

I want to make sure to be clear in my response that this doesn't in any way diminish our enthusiasm for biosimilar portfolio that we're developing.

我想確保在我的回復中明確表示，這不會以任何方式削弱我們對我們正在開發的生物仿製藥產品組合的熱情。

Just remind you we have six programs advancing, three of which are already in pivotal trials, and so we're excited about the prospect of developing and launching those beginning in 2017.

請提醒您，我們有六個項目正在推進，其中三個已經在進行關鍵試驗，因此我們對從 2017 年開始開發和啟動這些項目的前景感到興奮。

And you're right to point out that this enables and gives us an opportunity to rationalize some of our manufacturing capability.

你正確地指出，這使我們有機會合理化我們的一些製造能力。

And let me just at a high level remind you that we've talked over the past couple of years about our investments in manufacturing technologies and new processes that we think will enable us to make protein therapies more reliably and at lower cost than we currently do.

讓我在高級別提醒您，我們在過去幾年中討論了我們對製造技術和新工藝的投資，我們認為這將使我們能夠以比目前更可靠和更低的成本製造蛋白質療法.

And as we progress our investments in that area, we would expect that to free up some of our legacy manufacturing capacity.

隨著我們在該領域的投資取得進展，我們預計這將釋放我們的一些遺留製造能力。

So we're exiting a 20-year-old manufacturing technologies and continuing to invest in what we think are state-of-the-art cutting edge technologies that will enable us to again rationalize, and we think make product more reliably and more cost-effectively.

因此，我們正在退出已有 20 年曆史的製造技術，並繼續投資於我們認為最先進的尖端技術，這將使我們再次合理化，我們認為使產品更可靠，成本更低-有效。

Thanks.

謝謝。

Matt Roden, UBS.

馬特·羅登，瑞銀。

Hey guys, this is Andrew Peters in for Matt.

大家好，我是馬特的安德魯·彼得斯。

Thanks for taking our question.

感謝您提出我們的問題。

I have one for Tony on the EPOGEN and dialysis market.

我在 EPOGEN 和透析市場上有一個給 Tony 的。

As both branded and potentially biosimilars begin to come to market in the US, we wanted to get your thoughts on how you view the impacts of some of the large dialysis providers and potential volume deals and how you see kind of that moving forward once Roche comes in in the biosimilars as well.

隨著品牌生物仿製藥和潛在生物仿製藥開始在美國上市，我們想了解您對一些大型透析供應商和潛在交易量的影響的看法，以及一旦羅氏來了您如何看待這種情況的進展在生物仿製藥中也是如此。

Okay so just to remind you again that Roche has the right to enter the market at present with Mircera, and then the patent will expire during 2015.

好的，再次提醒您，羅氏目前有權使用 Mircera 進入市場，然後該專利將在 2015 年到期。

The market is divided into three large chunks, obviously DaVita and FMC holding about a third of the business, and the other third being held or managed by some of the small providers.

該市場分為三大塊，顯然 DaVita 和 FMC 持有大約三分之一的業務，另外三分之一由一些小型供應商持有或管理。

With regards to DaVita, we have an exclusive supply contract with them that runs until 2018, and with FMC, we have a non-exclusive agreement at present.

關於 DaVita，我們與他們簽訂了一份到 2018 年為止的獨家供應合同，而對於 FMC，我們目前有一份非獨家協議。

So obviously all the experiences that both FMC and a few others are having in Europe, which include a number of other alternative products, is something we take into account.

因此，顯然 FMC 和其他一些公司在歐洲的所有經驗，包括許多其他替代產品，都是我們考慮的因素。

We have continued to maintain a fairly large portion of the dialysis market share in Europe, so we are modeling ourselves on that but the market of course in the US is apparently different.

我們繼續在歐洲保持相當大的透析市場份額，因此我們正在以此為榜樣，但美國的市場當然明顯不同。

Great.

偉大的。

Thanks.

謝謝。

Eun Yang, Jefferies.

恩陽，傑富瑞。

Question on romosozumab for 785 in Phase II/III patients are treated with 785 for 12 months then followed by 24 months of Prolia.

關於 romosozumab 785 的問題 II/III 期患者接受 785 治療 12 個月，然後接受 24 個月的 Prolia。

Will that be less favorable for a primary outcome measured at 24 months, compared to 24 months continuous romosozumab treatment?

與連續 24 個月的 romosozumab 治療相比，這對於 24 個月時測量的主要結果是否更有利？

Thanks for the question.

謝謝你的問題。

Sean, why don't you respond?

肖恩，你為什麼不回應？

I think that the science of this novel pathway really led us to that approach, and what we found in our Phase II work with romosozumab is while one does see the most rapid increase in bone mineral density has been seen with any agent that's been introduced into humans.

我認為這種新途徑的科學確實使我們採用了這種方法，我們在使用 romosozumab 進行的 II 期研究中發現，雖然人們確實看到任何引入的藥物都能使骨密度增加最快人類。

It does plateau by a year, and by a year essentially what one is experiencing with continued use of romosozumab is a antiresorptive effect, a kind of magnitude effect that's generally similar to that which you would see with marketed antiresorptives.

它會在一年內達到穩定狀態，而在一年內，持續使用 romosozumab 所經歷的基本上是一種抗再吸收作用，一種與市售抗再吸收藥物通常相似的幅度效應。

And so at that point it didn't seem prudent to continue to dose people with an anabolic agent which is a novel mechanism et cetera, when we have the ability to adopt a paradigm of rapidly building bone in patients who require that, and then kind of locking in those gains with an antiresorptive such as Prolia.

所以在那個時候繼續給人們服用合成代謝劑似乎並不明智使用 Prolia 等抗再吸收劑鎖定這些收益。

So that was the surprise to us of course because this is completely novel biology, and it wasn't until we got into the clinic and worked with patients in Phase II that we found that it really wasn't sensible to use the product on a chronic basis.

所以這當然讓我們感到驚訝，因為這是一種全新的生物學，直到我們進入臨床並與處於 II 期的患者一起工作，我們才發現在臨床上使用該產品確實不明智慢性基礎。

Ian Somaiya, Nomura Securities.

野村證券的 Ian Somaiya。

Thanks.

謝謝。

Just a question on the restructuring.

只是關於重組的問題。

Should we expect any kind of pipeline reprioritization?

我們應該期待任何類型的管道重新排序嗎？

When we get to the business review meeting at the end of the year, and just as you think about 2016 and beyond, how much of the shift in spending to SG&A is sort of one-time in support of launching of these products?

當我們在年底召開業務審查會議時，正如您對 2016 年及以後的看法一樣，有多少支出轉向 SG&A 是一次性支持這些產品的推出？

And how much of it should we assume is recurring?

我們應該假設其中有多少是重複發生的？

Okay, thanks for those questions.

好的，謝謝你提出這些問題。

I'll invite Sean to respond to your pipeline question, but I'd just remind you that we've been doing a fair amount of re-priorities of the pipeline -- reprioritizing of the pipeline over the past two years.

我將邀請 Sean 回答您的管道問題，但我只想提醒您，我們一直在對管道進行大量的重新優先級調整——在過去兩年中重新確定管道的優先級。

But Sean you can reiterate actions that we've taken there if you like.

但是肖恩，如果你願意，你可以重申我們在那裡採取的行動。

And of course we'll talk about where we are focusing our efforts when we're together for the full business review, and we'd like to give you an update on our approaches in the discovery research as well as the molecules that we're excited about at an earlier stage of development that we haven't had as much time to talk about given the bolus of advanced molecules that we're currently developing.

當然，當我們在一起進行全面的業務審查時，我們會討論我們的工作重點，我們想向您介紹我們在發現研究中的方法以及我們的分子考慮到我們目前正在開發的大量先進分子，我們在開發的早期階段感到興奮，我們沒有那麼多時間來談論它。

And similarly, Ian, I'd ask that rather than getting into the details now of our investment in competitive molecules that we'll use the business review at year end or in the fourth quarter as an opportunity to update you on our thinking.

同樣，伊恩，我想問的是，與其現在詳細討論我們對競爭性分子的投資，我們將在年底或第四季度使用業務審查作為一個機會讓您了解我們的想法。

But you'll appreciate that the initial stages before launch of a molecule include considerable amount of investment prior to actually generating revenues.

但是您會明白，分子推出之前的初始階段包括在實際產生收入之前進行大量投資。

Sean?

肖恩？

I think it's obvious to folks that we have an unprecedented number of late-stage programs rolling through at the moment, and this is the nature of R&D at any given company.

我認為對人們來說顯而易見的是，我們目前正在開展數量空前的後期項目，這就是任何一家公司研發的本質。

It tends to be lumpy in this way and so as you're absorbing first enormous amounts of Phase III clinical trial expenses, those of course as a bolus like this moves through, they begin to roll off.

以這種方式它往往是塊狀的，所以當你首先吸收大量的 III 期臨床試驗費用時，這些費用當然是像這樣的一團一團通過的，它們開始滾落。

But the R&D expenses associated with supporting commercialization and the pharmacovigilance and regulatory activities, et cetera, in addition to supporting the new geographies that we're moving into are substantial investments.

但是，除了支持我們正在進入的新地區之外，與支持商業化和藥物警戒和監管活動等相關的研發費用是大量投資。

And then while we may not have this number of molecules at any given time at steady-state in late-stage development, we certainly want to have plenty.

然後，雖然我們在後期開發的任何給定時間可能都沒有這麼多分子處於穩定狀態，但我們當然希望擁有足夠多的分子。

And so we're going to be continuing to make significant investment both in internal innovation as well as to be looking externally to make sure we are capturing innovation appropriately.

因此，我們將繼續在內部創新方面進行大量投資，並在外部尋找機會，以確保我們能夠適當地捕捉創新。

If you look at our late-stage portfolio right now it definitely represents a mix of those two capabilities.

如果您現在查看我們的後期產品組合，它肯定代表了這兩種功能的組合。

Ravi Mehrotra, Credit Suisse

Ravi Mehrotra，瑞士信貸

Thanks for taking my question.

感謝您提出我的問題。

Sorry another one on headcount reduction.

抱歉另一個關於裁員的問題。

And thanks for all the color; you've partly answered this, but let me ask from a very philosophical perspective, is the headcount principally being driven to squeeze out operational inefficiencies, or with a greater goal of gaining structural advantages with a view of dominating select R&D and operational domains?

感謝所有的顏色；你已經部分回答了這個問題，但讓我從一個非常哲學的角度來問，員工人數主要是為了消除運營效率低下，還是為了獲得結構優勢以主導選定的研發和運營領域的更大目標？

And the second of these, are there any subtleties in the restructuring that you can highlight which we may miss in just the headline headcount reduction numbers?

第二，重組中是否有任何微妙之處，您可以強調哪些我們可能僅在標題裁員數字中遺漏？

Thank you

謝謝

Ravi, I think in our disclosure of the reductions we were clear and transparent about what our objectives for the move are.

拉維，我認為在我們披露裁員時，我們清楚透明地說明了我們此舉的目標。

And again what we're doing is we're carefully, we're selectively reallocating resources away from some of our legacy investment areas to some of these new areas that we think offer higher growth and better returns.

同樣，我們正在做的是我們非常謹慎，我們正在有選擇地將資源從我們的一些傳統投資領域重新分配到我們認為可以提供更高增長和更好回報的一些新領域。

And again, I don't think there's a lot of subtlety to it.

再一次，我不認為它有很多微妙之處。

We try to be quite clear and transparent about what we were trying to do, both as regard to the numbers, the locations, and what we're trying to do with our fixed cost from a site standpoint.

我們試圖對我們正在嘗試做的事情非常清楚和透明，無論是關於數字、位置，還是從站點的角度來看我們試圖用我們的固定成本來做的事情。

So again, I expect when we're together in the fourth quarter if there is need for more inside on the actions that we will have taken or in the process of taking, we can provide that for you.

因此，我希望當我們在第四季度聚在一起時，如果需要更多關於我們將採取或正在採取的行動的內部信息，我們可以為您提供。

Thank you.

謝謝你。

Howard Liang, Leerink.

Howard Liang，Leerink。

Can you talk about what additional commercial infrastructure you think you will need in order to launch Evolocumab and other products?

您能否談談您認為需要哪些額外的商業基礎設施才能推出 Evolocumab 和其他產品？

And with the $700 million benefit from the restructuring, would that be sufficient, or do you think you will need more buildup from other investment to build the infrastructure?

有了重組帶來的 7 億美元收益，這是否足夠，或者您是否認為您需要更多的其他投資來建設基礎設施？

This is Tony.

這是托尼。

It's clearly a very sensitive and competitive debate we'll have about this now.

很明顯，我們現在將就此展開一場非常敏感且競爭激烈的辯論。

But we're looking at putting together a definitive cardiovascular team, and that team will evolve over time as we then go from Ivabradine to Evolocumab.

但我們正在考慮組建一支明確的心血管團隊，隨著我們從伊伐布雷定轉向 Evolocumab，該團隊將隨著時間的推移而發展。

The other products we'll be launching pretty much within our existing organization in terms of the oncology skills.

就腫瘤學技能而言，我們將在現有組織內推出其他產品。

But that's about as much as we would want to discuss at this point in time.

但這就是我們此時想要討論的內容。

Great, thanks Tony.

太好了，謝謝托尼。

Let me thank everybody for your participation in our call this afternoon.

感謝大家參加今天下午的電話會議。

If you have any other questions or thoughts, obviously I together with the rest of my team will be around for the next several hours, so feel free to reach out to me.

如果您有任何其他問題或想法，顯然我和我團隊的其他成員將在接下來的幾個小時內在場，請隨時與我聯繫。

Thanks again.

再次感謝。

Ladies and gentlemen this concludes Amgen's second-quarter earnings conference call.

女士們，先生們，安進公司第二季度財報電話會議到此結束。

You may now disconnect.

您現在可以斷開連接。