美國安進 (AMGN) 2014 Q4 法說會逐字稿

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

我叫馬文，今天我將擔任安進第四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 hope the blizzard, for those of you in the Northeast, wasn't too disruptive.

我希望暴風雪對你們東北部的人來說沒有太大的破壞性。

I would like to welcome you to our conference call to review our operating performance for the fourth quarter and full year 2014.

歡迎您參加我們的電話會議，回顧我們 2014 年第四季度和全年的經營業績。

We accomplished a lot during 2014 on many fronts and we look forward to delivering once again for our shareholders in 2015.

2014 年，我們在許多方面都取得了很多成就，我們期待著在 2015 年再次為我們的股東做出貢獻。

While 2014 was characterized by significant clinical dataflow, 2015 will be characterized by regulatory submissions and new product launches.

雖然 2014 年的特點是大量的臨床數據流，但 2015 年的特點將是監管提交和新產品發布。

So leading the call today will be our Chairman and CEO, Bob Bradway, who will provide a strategic report on our performance in 2014 and outlook for 2015.

因此，今天主持電話會議的將是我們的董事長兼首席執行官 Bob Bradway，他將提供一份關於我們 2014 年業績和 2015 年展望的戰略報告。

Following Bob, our CFO, David Meline, will then review our Q4 and full-year results and address financial guidance for 2015.

在 Bob 之後，我們的首席財務官 David Meline 將審查我們的第四季度和全年業績，並提出 2015 年的財務指導。

Tony Hooper, our Head of Global Commercial Operations, will 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托尼·胡珀 (Tony Hooper) 將討論我們本季度的產品性能以及我們看到的未來趨勢。

And finally Sean Harper, our Head of R&D, will provide a pipeline update.

最後，我們的研發主管 Sean Harper 將提供管道更新。

After Sean's comments, we should have ample time for Q&A.

在 Sean 的評論之後，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。

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

這些幻燈片已發佈在我們的網站上，並且已通過電子郵件單獨向您發送了一個鏈接。

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，在我們今天的介紹和討論過程中，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 thank you, Arvind.

好的，謝謝你，阿文德。

I thank all of you for joining our call this afternoon.

感謝大家今天下午加入我們的電話會議。

2014 was really an outstanding year for us, and let me start with the financial highlights, which include revenue growth of 7% enabling us to eclipse $20 billion for the first time.

2014 年對我們來說確實是非凡的一年，讓我從財務亮點開始，其中包括 7% 的收入增長，使我們首次超過 200 億美元。

Consistent with our international expansion objectives, sales outside of the US grew by double-digit rates in 2014.

與我們的國際擴張目標一致，2014 年美國以外的銷售額以兩位數的速度增長。

Our adjusted operating income growth of 22% reflects our commitment to generating operating leverage from our business.

我們調整後的營業收入增長 22%，反映了我們致力於從我們的業務中產生經營槓桿。

As you know, one of our objectives for 2014 was to deliver to shareholders $800 million of improved profitability from Enbrel.

如您所知，我們 2014 年的目標之一是為股東帶來 8 億美元的 Enbrel 盈利能力提升。

We exceeded that objective in 2014.

我們在 2014 年超額完成了該目標。

In addition our free cash flow grew by 40% to $7.8 billion.

此外，我們的自由現金流增長了 40%，達到 78 億美元。

This strong financial performance,, and our confidence in the longer-term outlook, enabled us to increase our dividend by 30% in 2014 and by 30% again for 2015 while increasing our stock buyback plans as well.

這種強勁的財務表現，以及我們對長期前景的信心，使我們能夠在 2014 年將股息提高 30%，並在 2015 年再次提高 30%，同時還增加了我們的股票回購計劃。

Turning now to our progress with innovation, we had an extraordinary flow of data from our pipeline in 2014.

現在談談我們在創新方面取得的進展，2014 年我們的管道產生了非凡的數據流。

We generated positive pivotal data for six innovative programs and submitted four of them for regulatory approvals.

我們為六個創新項目生成了積極的關鍵數據，並提交了其中四個以供監管部門批准。

To remind you, this includes filings for two immuno-oncology molecules, BLINCYTO and TVEC; and two cardiovascular molecules, Evolocumab and Ivabradine.

提醒您，這包括兩種免疫腫瘤學分子 BLINCYTO 和 TVEC 的申報；以及兩種心血管分子，Evolocumab 和 Ivabradine。

In December we received FDA approval for two products, including BLINCYTO and our on-body injector for Neulasta.

12 月，我們獲得了 FDA 對兩種產品的批准，包括 BLINCYTO 和我們的 Neulasta 體內註射器。

BLINCYTO is an immuno-oncology agent which addresses an important need for acute lymphoblastic leukemia patients who currently have very limited options.

BLINCYTO 是一種免疫腫瘤藥物，可滿足目前選擇非常有限的急性淋巴細胞白血病患者的重要需求。

We are generally -- we are excited about the proof of concept represented by this approval and look forward to progressing our BiTE programs in other forms of cancer as well.

我們一般 - 我們對這一批准所代表的概念證明感到興奮，並期待在其他形式的癌症中推進我們的 BiTE 計劃。

Our on-body injector for Neulasta also represents an important innovation for cancer patients and one which will help improve patient experience for those undergoing chemotherapy and at high risk of infection.

我們的 Neulasta 體內註射器也代表了針對癌症患者的一項重要創新，它將有助於改善接受化療和感染高風險患者的體驗。

I'd like to point out of course that launches are now already underway for both of these products.

當然，我想指出這兩種產品的發布現在已經在進行中。

While 2014 was a watershed year for us in research and development, 2015 is sure to be another important year, starting with the prospects of launching three additional innovative products including Evolocumab of course for hypercholesterolemia, Ivabradine for heart failure, and TVEC for metastatic melanoma.

雖然 2014 年是我們研發的分水嶺，但 2015 年肯定又是重要的一年，首先是推出三種額外創新產品的前景，包括用於高膽固醇血症的 Evolocumab、用於心力衰竭的伊伐布雷定和用於轉移性黑色素瘤的 TVEC。

And in addition to these launches in 2015 we expect regulatory submissions for Kyprolis, which we announced earlier today, Brodalumab, and potentially AMG 416, as well as the start of a Phase III program for AMG 334 in migraine, and Phase III readouts from two of our biosimilar programs.

除了 2015 年的這些上市之外，我們預計我們今天早些時候宣布的 Kyprolis、Brodalumab 和潛在的 AMG 416 的監管提交，以及 AMG 334 治療偏頭痛的 III 期計劃的開始，以及來自兩個項目的 III 期讀數我們的生物仿製藥項目。

As we discussed in July and October, we began last year the process of transforming our Company and importantly we initiated this from a position of strength.

正如我們在 7 月和 10 月討論的那樣，我們從去年開始了對公司進行轉型的過程，重要的是，我們是從強大的地位開始的。

David will update you momentarily on our progress with that transformation and the benefits achieved in 2014.

David 將立即向您介紹我們在轉型方面取得的進展以及 2014 年取得的收益。

We are on track, as reflected in our $1.5 billion growth in operating income and 6-point operating margin improvement last year, even while absorbing the full-year impact of Onyx and investing in our launch opportunities.

正如去年我們 15 億美元的營業收入增長和 6 個百分點的營業利潤率提高所反映的那樣，我們正在走上正軌，即使在吸收 Onyx 的全年影響並投資於我們的發布機會時也是如此。

Across our Company, we will continue our transformation efforts in 2015 and deliver more progress against our long-term objectives.

在整個公司，我們將在 2015 年繼續我們的轉型努力，並在實現我們的長期目標方面取得更大進展。

Before I hand it over to David, let me thank my Amgen colleagues, many of whom are listening to this call, for their unwavering focus on delivering for patients and for shareholders.

在我把它交給大衛之前，讓我感謝我的安進同事，他們中的許多人都在聽這個電話會議，感謝他們堅定不移地專注於為患者和股東提供服務。

David?

大衛？

Okay thanks, Bob.

好的，謝謝，鮑勃。

Turning to the fourth quarter on page 5 of the slide deck, revenues grew to $5.3 billion, 6% year over year, with 8% product sales growth driven by continued momentum across our product portfolio.

轉到幻燈片第 5 頁上的第四季度，收入增長到 53 億美元，同比增長 6%，在我們產品組合的持續增長勢頭推動下，產品銷售額增長了 8%。

Other revenues at $187 million decreased by $55 million versus the fourth quarter of 2013 reflecting a reduced level of partnership payments received for Brodalumab compared to last year's fourth quarter.

其他收入為 1.87 億美元，與 2013 年第四季度相比減少了 5500 萬美元，反映出與去年第四季度相比，Brodalumab 收到的合作夥伴付款水平有所下降。

Adjusted operating income at $2 billion grew 15% from prior year.

調整後營業收入為 20 億美元，比上年增長 15%。

On an adjusted basis, the cost of sales margin at 15.9% improved by 0.1 points.

在調整後的基礎上，銷售利潤成本為 15.9%，提高了 0.1 個百分點。

Research and development expenses at $1.2 billion were flat versus prior year and included the $60 million upfront payment to Kite Pharma for our cancer immunotherapy collaboration.

研發費用為 12 億美元，與上年持平，其中包括為我們的癌症免疫療法合作向 Kite Pharma 支付的 6000 萬美元預付款。

SG&A expenses were flat year on year.

SG&A 費用同比持平。

On October 31, 2014, the Company passed the one-year anniversary of the first stepdown in Enbrel related payments.

2014 年 10 月 31 日，公司度過了首次降級 Enbrel 相關款項一周年。

This resulted in a year-over-year expense decline of approximately $100 million in Q4.

這導致第四季度費用同比下降約 1 億美元。

This compares to year-over-year expense declines of approximately $250 million per quarter in the first three quarters of 2014.

相比之下，2014 年前三個季度每季度費用同比下降約 2.5 億美元。

Additionally we incurred incremental expenses in Q4 in preparation for new product launches.

此外，我們在第四季度為準備新產品發布增加了費用。

These increased investments were offset through savings from our transformation to a more focused operating model, as well as through the reduced Enbrel related payments.

這些增加的投資被我們轉型為更專注的運營模式所節省的資金以及減少與 Enbrel 相關的付款所抵消。

Other income and expenses were flat year over year at $173 million in the quarter.

本季度其他收入和支出為 1.73 億美元，同比持平。

The tax rate was 10.2% for the quarter, a 2.5 point decrease versus Q4 2013.

本季度的稅率為 10.2%，比 2013 年第四季度下降 2.5 個百分點。

This decrease was primarily due to the favorable tax benefit from the extension of the 2014 federal R&D tax credit which occurred in Q4 of 2014, which was offset partially by unfavorable tax impact of changes in the geographic mix of earnings.

這一減少主要是由於 2014 年第四季度發生的 2014 年聯邦研發稅收抵免的延期帶來的稅收優惠，部分被收入地域組合變化的不利稅收影響所抵消。

As a result, adjusted net income increased 20% and adjusted earnings per share increased 19%.

因此，調整後的淨收入增長了 20%，調整後的每股收益增長了 19%。

In summary our fourth-quarter results from operations were in line with our previous expectations, while overall results in the quarter benefited from the extension of the R&D tax credit, which was approved in late December and had been removed from our previous guidance.

總而言之，我們第四季度的運營業績符合我們之前的預期，而本季度的整體業績受益於研發稅收抵免的延長，該延期於 12 月下旬獲得批准，並已從我們之前的指導中刪除。

You'll find a summary of our 2014 full-year results on page 6 of the presentation.

您可以在演示文稿的第 6 頁找到我們 2014 年全年業績的摘要。

Our 2014 full-year revenues grew 7% to $20.1 billion, and adjusted earnings per share grew 14% to $8.70 per share.

我們 2014 年全年收入增長 7% 至 201 億美元，調整後每股收益增長 14% 至每股 8.70 美元。

Product sales grew 6% year over year and other revenues increased by $252 million over the same period a year ago, primarily driven by our Nexavar and Stivarga partnerships.

產品銷售額同比增長 6%，其他收入同比增長 2.52 億美元，這主要得益於我們與 Nexavar 和 Stivarga 的合作夥伴關係。

For the full year, adjusted operating income grew to $8.5 billion, a 22% increase based on the combination of solid revenue growth along with stable operating expenses which were down 1% year over year.

全年，調整後的營業收入增長 22% 至 85 億美元，這主要得益於穩健的收入增長和穩定的營業支出，同比下降 1%。

On an adjusted basis, cost of sales margin was flat at 15.8% year over year.

在調整後的基礎上，銷售利潤成本同比持平於 15.8%。

Research and development expenses increased 5% driven by the addition of Onyx and support for later stage clinical programs.

在 Onyx 的加入和對後期臨床項目的支持的推動下，研發費用增加了 5%。

These increases were offset partially by lower spending associated with marketed product support.

這些增長部分被與營銷產品支持相關的支出減少所抵消。

SG&A expenses were down 10% driven primarily by reduced Enbrel related expenses, offset partially by the addition of Onyx and increased commercial expenses in preparation for new product launches.

SG&A 費用下降了 10%，主要是由於 Enbrel 相關費用減少，部分被 Onyx 的增加和為新產品發布做準備的商業費用增加所抵消。

Other income and expenses were unfavorable 7% year over year due to higher interest expense and portfolio rebalancing, partially offset by higher interest income.

由於較高的利息支出和投資組合再平衡，其他收入和支出同比增長 7%，但部分被較高的利息收入所抵消。

The tax rate was 14.9% for the full year, up 5.7 points versus 2013.

全年稅率為14.9%，比2013年提高5.7個百分點。

The year-over-year increase was primarily due to favorable resolution in 2013 of our federal income tax audit, as well as the retroactive extension of the 2012 federal R&D tax credit in 2013.

同比增長主要是由於 2013 年聯邦所得稅審計的有利決議，以及 2013 年 2012 年聯邦研發稅收抵免的追溯延期。

During 2014 the impact of the Puerto Rico excise tax was 1.9 points higher in cost of sales and 3.3 points lower in our adjusted tax rate.

2014 年，波多黎各消費稅的影響是銷售成本增加 1.9 個百分點，調整後的稅率降低 3.3 個百分點。

We would expect a similar impact to continue through 2017.

我們預計類似的影響將持續到 2017 年。

Turning to page 7, I would like to take a moment to provide an update on Amgen's transformation initiatives which we previously discussed at our July and October 2014 investor events.

翻到第 7 頁，我想花點時間介紹一下我們之前在 2014 年 7 月和 2014 年 10 月的投資者活動中討論過的 Amgen 轉型計劃的最新情況。

2015 marks an exciting year as we are in full execution mode towards our focused operating model.

2015 年是激動人心的一年，因為我們正全面執行我們專注的運營模式。

We are advancing a number of key initiatives to streamline processes, increase agility and efficiencies, and improve operating performance.

我們正在推進一系列關鍵舉措，以簡化流程、提高敏捷性和效率，並改善運營績效。

We also have completed and largely implemented the first phase of reductions in workforce announced in July, which will total approximately 3,000, and have made significant progress on reducing our facilities footprint towards the 23% goal.

我們還完成並在很大程度上實施了 7 月份宣布的第一階段裁員計劃，裁員總數約為 3,000 人，並且在減少設施足跡以實現 23% 的目標方面取得了重大進展。

In terms of the 2014 impact, all areas of operating expense benefited as our transformation to a focused operating model began to generate cost efficiencies.

就 2014 年的影響而言，隨著我們向專注運營模式的轉型開始產生成本效益，運營費用的所有領域都受益。

In 2014 we realized approximately $300 million of cost savings towards our $1.5 billion goal.

2014 年，我們實現了 15 億美元的目標，節省了大約 3 億美元的成本。

This includes lower labor costs from workforce reductions and sales force optimization.

這包括通過裁員和優化銷售人員來降低勞動力成本。

It also includes lower external expenses from improved contracting and sourcing and rationalizing discretionary spend categories.

它還包括通過改進合同和採購以及合理化可自由支配的支出類別來降低外部費用。

In 2015 we expect incremental savings of at least $400 million.

2015 年，我們預計將至少節省 4 億美元。

This will in large part be driven by the annualization of savings following the reductions in workforce, which occurred in late 2014.

這在很大程度上是由於 2014 年底發生的勞動力減少後的年化節省所致。

It also includes greater use of shared services and further external spend improvements resulting from the rigorous transformation initiatives developed over the past year.

它還包括更多地使用共享服務，以及由於過去一年制定的嚴格轉型計劃而進一步改善外部支出。

These savings will be redeployed to underwrite launch investments and one-time transition costs incurred as part of the transformation implementation.

這些節省的資金將被重新用於承保啟動投資和作為轉型實施的一部分而產生的一次性過渡成本。

As a result of revenue growth and expense discipline in 2015 we will further improve adjusted operating margins on the trajectory to our 2018 target of 52% to 54% through improved operating leverage.

由於 2015 年的收入增長和支出紀律，我們將通過提高運營槓桿率進一步提高調整後的運營利潤率，使我們的 2018 年目標達到 52% 至 54%。

We will continue to provide periodic updates on our transformation progress going forward.

我們將繼續定期更新我們未來的轉型進展。

Turning next to cash flow and the balance sheet on page 8. Based on our confidence in the performance of the business going forward, we announced a commitment to return 60% of adjusted net income to shareholders through 2018 while continuing to invest strongly in our business.

接下來轉到第 8 頁的現金流和資產負債表。基於我們對未來業務表現的信心，我們宣布承諾到 2018 年將調整後淨收入的 60% 返還給股東，同時繼續大力投資我們的業務.

For the full year 2014 we generated $7.8 billion in free cash flow, an increase of $2.2 billion over the prior year.

2014 年全年，我們產生了 78 億美元的自由現金流，比上一年增加了 22 億美元。

This increase was driven by higher sales and profitability, as well as improvement in working capital, a portion of which are permanent.

這一增長是由更高的銷售額和盈利能力以及營運資金的改善推動的，其中一部分是永久性的。

As a result of the strong cash flow performance total debt outstanding declined to $30.7 billion and total cash and investments increased to $27 billion.

由於強勁的現金流表現，未償還債務總額下降至 307 億美元，現金和投資總額增加至 270 億美元。

As a result, net debt improved by $5.6 billion to $3.7 billion at year end 2014.

因此，2014 年底的淨債務減少了 56 億美元，達到 37 億美元。

Additionally for 2014, we increased our quarterly dividend per share by 30% to $0.61 with payments totaling $1.9 billion.

此外，對於 2014 年，我們將每股季度股息提高了 30% 至 0.61 美元，支付總額為 19 億美元。

We also announced another 30% increase to the dividend to $0.79 per share, starting with our first quarter 2015 payment.

我們還宣布從 2015 年第一季度開始，將股息再增加 30% 至每股 0.79 美元。

Finally, at our October meeting, we indicated the intent to accelerate the re-initiation of our share repurchase program with up to $2 billion of repurchases by the end of 2015.

最後，在 10 月份的會議上，我們表示有意加快重新啟動我們的股票回購計劃，到 2015 年底回購金額高達 20 億美元。

In the fourth quarter we took a first step towards this commitment with $153 million deployed to repurchase approximately 900,000 shares in the period.

在第四季度，我們為實現這一承諾邁出了第一步，部署了 1.53 億美元，用於回購該期間約 900,000 股股票。

We intend to continue repurchases at a stepped up level in 2015.

我們打算在 2015 年繼續加大回購力度。

At the end of 2014 we had approximately $3.8 billion remaining under our board-authorized share repurchase program.

2014 年底，我們的董事會授權股票回購計劃剩餘約 38 億美元。

I will now turn to guidance for 2015.

我現在將轉向 2015 年的指導。

Please turn to page 9.

請翻到第 9 頁。

As you will recall, we provided preliminary 2015 guidance at our October business review.

您會記得，我們在 10 月份的業務回顧中提供了 2015 年的初步指導。

In terms of what has changed since that time, we completed 2014 with solid in-line operating performance with full-year results of 7% revenue growth, 22% adjusted operating income growth, and 14% adjusted EPS growth.

就自那時以來發生的變化而言，我們以穩健的在線經營業績結束了 2014 年，全年收入增長 7%，調整後營業收入增長 22%，調整後每股收益增長 14%。

With this background we remain confident in the outlook for 2015 despite additional potential foreign exchange headwinds.

在此背景下，儘管存在額外的潛在外匯逆風，我們仍然對 2015 年的前景充滿信心。

Today we are reaffirming our 2015 revenue guidance of $20.8 billion to $21.3 billion, adjusted tax rate of 18% to 19%, which excludes the benefit of the federal R&D tax credit in 2015, and adjusted earnings per share of $9.05 to $9.40 a share.

今天，我們重申 2015 年的收入指引為 208 億美元至 213 億美元，調整後的稅率為 18% 至 19%，其中不包括 2015 年聯邦研發稅收抵免的好處，調整後的每股收益為 9.05 美元至 9.40 美元。

Finally capital expenditures are planned at $800 million this year.

最後，今年的資本支出計劃為 8 億美元。

This concludes the financial update.

財務更新到此結束。

I now turn the call over to Tony.

我現在把電話轉給托尼。

Thank you David.

謝謝大衛。

Good afternoon, folks.

下午好，伙計們。

You'll find a summary of our global sales performance for the fourth quarter starting on slide number 11.

從第 11 號幻燈片開始，您將找到我們第四季度全球銷售業績的摘要。

The underlying prescription demand remains strong as we enter 2015.

進入 2015 年，潛在的處方藥需求依然強勁。

In 2014 the majority of products grew in volume terms across both US and ex-US markets in quarter four, as well as on a full-year basis.

2014 年，大多數產品在美國和美國以外市場的銷量在第四季度以及全年都有增長。

Globally, product sales grew 8% year over year and 6% for the full year.

在全球範圍內，產品銷售額同比增長 8%，全年增長 6%。

Our international business grew 11% in the fourth quarter, excluding the negative impact of foreign exchange.

剔除外彙的負面影響，我們的國際業務在第四季度增長了 11%。

Our new and emerging markets delivered just over $1 billion in sales in 2014.

2014 年，我們新興市場的銷售額剛剛超過 10 億美元。

So far, the first quarter of 2015 is playing out as anticipated.

到目前為止，2015 年第一季度的表現符合預期。

We are on track for the full year.

我們全年都在按計劃進行。

And let me remind you that products like Prolia and Enbrel historically experience slower first quarters.

讓我提醒您，Prolia 和 Enbrel 等產品歷來在第一季度表現較慢。

In assessing quarter-over-quarter performance it's important to note US wholesaler inventory dynamics.

在評估季度業績時，重要的是要注意美國批發商的庫存動態。

On average, wholesaler inventory levels returned to normal from rather low levels at the end of quarter three.

平均而言，批發商庫存水平從第三季度末的較低水平恢復正常。

There are some exceptions on a product basis which I will cover later.

有一些基於產品的例外情況，我將在稍後介紹。

Let me now turn to the fourth-quarter performance beginning with Enbrel.

現在讓我談談從 Enbrel 開始的第四季度業績。

Enbrel delivered strong growth of 11% year over year in the fourth quarter.

Enbrel 在第四季度實現了 11% 的強勁同比增長。

Underlying demand remains strong as both the rheumatology and dermatology segments grew on a value basis by 24%.

由於風濕病學和皮膚病學領域的價值增長了 24%，因此潛在需求依然強勁。

As expected, in the fourth quarter, we saw inventory levels increase from the relatively low levels we reported in quarter three.

正如預期的那樣，在第四季度，我們看到庫存水平比我們在第三季度報告的相對較低水平有所增加。

Quarter four ended with approximately $40 million higher wholesaler inventories than normal.

第四季度結束時，批發商庫存比正常情況高出約 4000 萬美元。

We expect to see the drawdown of the slight build along with the typical seasonality in the first quarter.

我們預計第一季度會隨著典型的季節性因素出現輕微增長的縮減。

We remain confident in the value potential of Enbrel and expect to continue to drive meaningful growth during 2015.

我們仍然對 Enbrel 的價值潛力充滿信心，並期望在 2015 年繼續推動有意義的增長。

Now turning to our Filgrastim franchise starting with Neulasta.

現在轉向我們的 Filgrastim 特許經營權，從 Neulasta 開始。

Neulasta delivered year-over-year growth of 7% in the fourth quarter.

Neulasta 在第四季度實現了 7% 的同比增長。

The growth was driven mainly by price and to a lesser extent unit demand, which included the benefit of the commercial rights we acquired outside the US from Roche as part of our international expansion strategy.

增長主要受價格驅動，其次是單位需求，其中包括作為我們國際擴張戰略的一部分，我們從羅氏公司獲得的美國境外商業權利的好處。

As Bob said, the FDA recently approved the Neulasta on-body injector and we look forward to bringing this innovative product to patients in the US shortly.

正如 Bob 所說，FDA 最近批准了 Neulasta 貼身注射器，我們期待很快將這一創新產品帶給美國患者。

The Neulasta on-body injector better serves patient needs and provides important differentiation from potential future competition.

Neulasta 貼身注射器更好地滿足了患者的需求，並提供了與未來潛在競爭的重要區別。

Next, Neupogen, which declined 11% year over year in the fourth quarter, due to branded short-acting competition in the US, as well as unfavorable changes in inventory levels and foreign exchange rates.

其次是 Neupogen，第四季度同比下降 11%，原因是美國的短效品牌競爭以及庫存水平和匯率的不利變化。

Like Neulasta, this was partially offset by the benefit of the commercial rights we acquired from Roche.

與 Neulasta 一樣，這部分被我們從羅氏獲得的商業權利所抵消。

In the US, 15 months into the launch of its first new competitor, Neupogen has retained over 80% share of the short-acting segment.

在美國，Neupogen 在推出其第一個新競爭對手 15 個月後，仍保留了 80% 以上的短效市場份額。

The balance of the market is split between Granix and Leukine.

市場的平衡被 Granix 和 Leukine 瓜分。

We continue to compete account by account and reinforce Neupogen's long track record of clinical efficacy and reliable supply to patients.

我們繼續逐個賬戶競爭，並加強 Neupogen 在臨床療效和向患者可靠供應方面的長期記錄。

With potential competition from biosimilars expected in the US, we will leverage the success we've had in the US versus branded competition, as well as our considerable experience with Neupogen biosimilars in Europe.

鑑於預計美國將面臨來自生物仿製藥的潛在競爭，我們將利用我們在美國與品牌競爭中取得的成功，以及我們在歐洲使用 Neupogen 生物仿製藥的豐富經驗。

I'll now move to our Denosumab franchise starting with Prolia.

我現在將轉向我們的 Denosumab 專營權，從 Prolia 開始。

Prolia delivered 33% growth year over year as we continue to capture share in both the US and Europe.

隨著我們繼續在美國和歐洲佔據份額，Prolia 實現了 33% 的同比增長。

In the US, unit share grew 6 percentage points over the year, exiting at 19% in the fourth quarter.

在美國，單位份額同比增長 6 個百分點，第四季度為 19%。

We continue to see strong response from our DTC campaign with one in three patients who start postmenopausal osteoporosis treatment being prescribed Prolia.

我們繼續看到我們的 DTC 運動產生強烈反響，三分之一的開始絕經後骨質疏鬆症治療的患者被開具 Prolia 處方。

In Europe we completed the buyback of the Prolia rights from GSK and transitioned the entire business to Amgen.

在歐洲，我們完成了從葛蘭素史克手中回購 Prolia 的權利，並將整個業務轉移到安進（Amgen）。

We now also have reimbursement across all EU countries.

我們現在還可以在所有歐盟國家/地區獲得報銷。

Unit share grew 4 percentage points over the year, exiting at 13% in the fourth quarter.

單位份額同比增長 4 個百分點，第四季度為 13%。

Both the US and Europe have opportunity for continued growth.

美國和歐洲都有持續增長的機會。

XGEVA continues to capture share in the US and EU markets and we expect to see continued segment share growth throughout 2015.

XGEVA 繼續佔領美國和歐盟市場的份額，我們預計整個 2015 年細分市場份額將持續增長。

US unit share increased 4 percentage points over the year and is now just under half the segment.

美國的單位份額在一年中增加了 4 個百分點，現在略低於該細分市場的一半。

In Europe unit share increased 8 percentage points for the year and is now just over one third of the European market.

在歐洲，單位份額今年增加了 8 個百分點，目前僅佔歐洲市場的三分之一多一點。

Our brand strategy continues to focus on XGEVA's superior clinical profile.

我們的品牌戰略繼續關注 XGEVA 卓越的臨床形象。

Vectibix grew 29% year over year and continues to show strong unit growth across all regions, gaining share in first-line metastatic colorectal cancer in both the US and Europe.

Vectibix 同比增長 29%，並繼續在所有地區顯示強勁的單位增長，在美國和歐洲的一線轉移性結直腸癌中獲得份額。

Now let's turn to Kyprolis, which delivered year-over-year growth of 25% following the acquisition of Onyx in quarter four 2013.

現在讓我們來看看 Kyprolis，它在 2013 年第四季度收購 Onyx 後實現了 25% 的同比增長。

Quarter over quarter we saw continued unit growth at 6% in the US, but overall net sales declined slightly due to an inventory drawdown.

季度環比，我們看到美國的銷量持續增長 6%，但由於庫存減少，整體淨銷售額略有下降。

Kyprolis continues to maintain leading 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領先地位。

As announced earlier, I'm delighted that we completed the submission of the regulatory applications for treatment of relapsed multiple myeloma in both the US and Europe.

正如之前宣布的那樣，我很高興我們在美國和歐洲完成了治療復發性多發性骨髓瘤的監管申請的提交。

Getting this into the label in the US and launching in Europe will be the next major inflection point for Kyprolis.

在美國貼牌並在歐洲上市將是 Kyprolis 的下一個主要轉折點。

We look forward to enabling more patients to benefit from Kyprolis following these regulatory approvals.

我們期待在獲得這些監管批准後，讓更多患者能夠從 Kyprolis 中受益。

Next is Epogen, which grew 3% year over year.

其次是 Epogen，同比增長 3%。

Increases in price were offset by unit declines.

價格上漲被銷量下降所抵消。

Fourth-quarter 2013 volume included a few large customer buy-ins that did not occur in the fourth quarter of 2014.

2013 年第四季度的成交量包括一些 2014 年第四季度沒有發生的大客戶買入。

Aranesp sales grew 2% year over year with unit growth from a few large customer buy-ins in the US.

Aranesp 銷售額同比增長 2%，得益於美國一些大客戶的購買量增長。

Sensipar saw year-over-year growth of 3% as 10% unit growth and higher prices were offset by low inventory levels.

Sensipar 的同比增長率為 3%，因為 10% 的單位增長率和較高的價格被低庫存水平所抵消。

Nplate continues to grow in both the US and European markets driving 7% unit growth.

Nplate 在美國和歐洲市場繼續增長，推動 7% 的單位增長。

Quarter four was negatively impacted by inventory declines.

第四季度受到庫存下降的負面影響。

Lastly BLINCYTO, we are pleased with the initial launch of BLINCYTO following the swift FDA approval in December.

最後是 BLINCYTO，我們很高興在 12 月獲得 FDA 的迅速批准後首次推出 BLINCYTO。

Physician and patient responses are indicative of the significant unmet need for patients with relapsed and refractory ALL.

醫生和患者的反應表明復發和難治性 ALL 患者的需求未得到滿足。

Regarding our upcoming launches, I'd like to share with you that our cardiovascular specialty sales force is now in place focusing on disease state awareness and profiling target segments.

關於我們即將推出的產品，我想與您分享，我們的心血管專業銷售團隊現已到位，專注於疾病狀態意識和分析目標細分市場。

We look forward to launching Corlanor, the new brand name for Ivabradine in the US, and Repatha, the new global brand name for Evolocumab, later this year.

我們期待在今年晚些時候推出 Ivabradine 在美國的新品牌 Corlanor 和 Evolocumab 的新全球品牌 Repatha。

We see a significant opportunity to address unmet need with these two medicines.

我們看到了用這兩種藥物解決未滿足需求的重要機會。

In the US over 1 million medically eligible chronic heart failure payments would benefit from Corlanor treatment once approved.

在美國，一旦獲得批准，超過 100 萬符合醫學條件的慢性心力衰竭付款將受益於 Corlanor 治療。

In the US, Europe, and Japan over 25 million people at risk for cardiovascular disease have LDL above 100 g/dL, despite current treatments, and could benefit from Repatha once approved.

在美國、歐洲和日本，超過 2500 萬處於心血管疾病風險中的人的 LDL 高於 100 g/dL，儘管目前正在接受治療，並且一旦獲得批准，他們可能會從 Repatha 中受益。

In closing I'm confident in the strength of our underlying business and I'd like to thank the Amgen teams around the world for their outstanding performance in 2014.

最後，我對我們基礎業務的實力充滿信心，我要感謝世界各地的安進團隊在 2014 年的出色表現。

Looking forward, our focus in 2015 will be threefold.

展望未來，我們在 2015 年的重點將分為三個方面。

Firstly, to build on the performance of growth products such as Enbrel, Prolia, XGEVA, Vectibix, Sensipar, and Nplate.

首先，以 Enbrel、Prolia、XGEVA、Vectibix、Sensipar 和 Nplate 等增長產品的性能為基礎。

Secondly, to successfully defend our mature brands from potential new biosimilars and branded competition, and thirdly to launch several important new medicines.

其次，成功地保護我們的成熟品牌免受潛在的新生物仿製藥和品牌競爭的影響，第三，推出幾個重要的新藥。

Let me now pass it to Sean.

現在讓我把它傳遞給肖恩。

Thanks, Tony, and good afternoon.

謝謝，托尼，下午好。

2014 was a very productive year for R&D and the last several months have been eventful as well with one regulatory highlight being the FDA approval of BLINCYTO in a remarkable 2.5 months after initial submission.

2014 年是研發成果豐碩的一年，過去幾個月也是多事之秋，其中一個監管亮點是 FDA 在首次提交後 2.5 個月內批准了 BLINCYTO。

I'd like to thank the FDA and Amgen staff who worked tirelessly to drive this outcome.

我要感謝 FDA 和 Amgen 的工作人員，他們為推動這一結果不懈努力。

BLINCYTO provides patients with a breakthrough therapy for a terrible disease, relapsed refractory acute lymphoblastic leukemia, or ALL, and clearly validates our BiTE immuno-oncology platform.

BLINCYTO 為患者提供了一種治療可怕疾病、復發難治性急性淋巴細胞白血病或 ALL 的突破性療法，並清楚地驗證了我們的 BiTE 免疫腫瘤學平台。

We look forward to introducing our next BiTE, AMG 330, into the clinic directed at acute myelogenous leukemia later this year.

我們期待在今年晚些時候將我們的下一個 BiTE AMG 330 引入針對急性髓性白血病的臨床。

We were also very pleased to receive FDA approval for the novel on-body injection system for Neulasta, which will help address the issue of having to administer Neulasta no sooner than 24 hours following chemotherapy, which can be difficult for cancer patients and interfere with optimal use of the product.

我們也很高興獲得 FDA 批准用於 Neulasta 的新型全身注射系統，這將有助於解決必須在化療後 24 小時內使用 Neulasta 的問題，這對癌症患者來說可能很困難，並且會干擾最佳狀態產品的使用。

As we announced today, we have submitted marketing applications for Kyprolis in the US and Europe in relapsed multiple myeloma, based on the Aspire data, which as you know was presented in detail at the ASH meeting and published in the New England Journal of Medicine late last year.

正如我們今天宣布的那樣，我們已經根據 Aspire 數據提交了 Kyprolis 在美國和歐洲用於治療復發性多發性骨髓瘤的營銷申請，如您所知，這些數據已在 ASH 會議上詳細介紹，並於晚些時候發表在新英格蘭醫學雜誌上去年。

We look forward to working with regulators to make Kyprolis available to patients with earlier stage relapsed multiple myeloma globally.

我們期待與監管機構合作，讓全球早期復發性多發性骨髓瘤患者能夠使用 Kyprolis。

Two of our submissions under review by FDA did receive three-month extensions to their target action dates, T-VEC for metastatic melanoma and Corlanor or Ivabradine for chronic heart failure.

我們提交給 FDA 審查的兩份申請確實收到了三個月的目標行動日期延期，T-VEC 用於轉移性黑色素瘤，Corlanor 或 Ivabradine 用於慢性心力衰竭。

In the case of T-VEC the agency requested additional manufacturing data for this very unique product which may require additional review time.

對於 T-VEC，該機構要求為這種非常獨特的產品提供額外的製造數據，這可能需要額外的審查時間。

In the case of Corlanor, the agency requested more of the existing clinical data than were originally agreed to for our heart-failure specific submission, also potentially requiring the additional review time.

在 Corlanor 的案例中，該機構要求提供比最初同意的更多的現有臨床數據，用於我們的心力衰竭特定提交，也可能需要額外的審查時間。

We provided the data for both programs as requested and we continue to work productively with regulators to bring these innovative medicines to the patients that need them as soon as possible.

我們按要求提供了這兩個項目的數據，並繼續與監管機構進行富有成效的合作，盡快將這些創新藥物帶給需要它們的患者。

For Repatha or Evolocumab our coronary intravascular ultrasound study, which is critical for the product, has completed enrollment.

對於 Repatha 或 Evolocumab，我們對產品至關重要的冠狀動脈血管內超聲研究已完成入組。

And our outcomes study continues to enroll very well.

我們的結果研究繼續很好地招募。

We're also working closely with regulators on our filings.

我們還與監管機構就我們的備案工作密切合作。

We will also be presenting some new analyses from our Evolocumab clinical program at the upcoming American College of Cardiology scientific session, including analyses of cardiovascular events in our ongoing open label extension studies.

我們還將在即將舉行的美國心髒病學會科學會議上展示我們的 Evolocumab 臨床計劃的一些新分析，包括我們正在進行的開放標籤擴展研究中的心血管事件分析。

AMG 334, our CGRP receptor antibody, performed very nicely in a Phase IIB dose ranging study, with patients with episodic migraines, resulting in our decision to move aggressively into Phase III later this year.

AMG 334，我們的 CGRP 受體抗體，在 IIB 期劑量範圍研究中表現非常好，患者為發作性偏頭痛患者，因此我們決定在今年晚些時候積極進入 III 期。

These data will be presented at the scientific forum in the first half of this year.

這些數據將在今年上半年的科學論壇上公佈。

The Phase IIB dose ranging study in chronic migraine is currently enrolled.

目前正在招募慢性偏頭痛的 IIB 期劑量範圍研究。

We feel AMG 334 has a clear potential to be a best in class agent for migraine prophylaxis with a favorable dose and schedule as a result of blocking the receptor rather than the ligand.

我們認為 AMG 334 具有明顯的潛力，可以通過阻斷受體而不是配體，以有利的劑量和時間表成為同類最佳的偏頭痛預防藥物。

We generated positive data from three Phase III psoriasis studies of Brodalumab, our IL17 receptor antibody, in 2014, including two studies that demonstrated superiority to Stelara, and we and our partners at AstraZeneca plan to file this data later this year.

我們在 2014 年從我們的 IL17 受體抗體 Brodalumab 的三項 III 期銀屑病研究中獲得了積極數據，其中包括兩項證明優於 Stelara 的研究，我們和我們在阿斯利康的合作夥伴計劃在今年晚些時候提交這些數據。

We also expect Phase III head-to-head data for AMG 416, our intravenous calcimimetic, against Sensipar in the first half of this year.

我們還預計今年上半年 AMG 416（我們的靜脈內擬鈣劑）與 Sensipar 的 III 期頭對頭數據。

This year we will also be reviewing the results of our Phase IIB study with the oral formulation of AMG 423, or omecamtiv mecarbil, the innovative cardiac myosin activator we are developing with Cytokinetics.

今年，我們還將審查我們使用 AMG 423 或 omecamtiv mecarbil 口服製劑的 IIB 期研究的結果，這是我們正在與細胞動力學開發的創新心肌肌球蛋白激活劑。

These data will be critical in informing our decision on advancing AMG 423 into Phase III.

這些數據對於我們決定將 AMG 423 推進 III 期至關重要。

Turning to our oncology pipeline, in addition to our T-VEC combination study with Ipilimumab, we've initiated a combination metastatic melanoma study with T-VEC and Merck's PD-1 antibody, and are in the planning stage for additional such combination checkpoint inhibitor studies in other tumor types.

談到我們的腫瘤管道，除了我們與 Ipilimumab 的 T-VEC 聯合研究外，我們還啟動了與 T-VEC 和默克公司的 PD-1 抗體的聯合轉移性黑色素瘤研究，並且正處於其他此類聯合檢查點抑製劑的計劃階段其他腫瘤類型的研究。

We presented BLINCYTO phase II data for both minimal residual disease positive patients with ALL and our pivotal relapsed refractory study in ALL at ASH, along with Phase II data from our lymphoma study.

我們在 ASH 上展示了微小殘留病陽性 ALL 患者的 BLINCYTO II 期數據和我們在 ALL 中的關鍵性複發難治性研究，以及我們的淋巴瘤研究的 II 期數據。

We also presented data from Vectibix Phase II PEAK study and Phase III PRIME studies supporting our approval for first-line use with FOLFOX in metastatic colorectal cancer at the ASCO annual meeting and ASCO Gastrointestinal Cancer Symposium.

我們還在 ASCO 年會和 ASCO 胃腸癌研討會上展示了 Vectibix II 期 PEAK 研究和 III 期 PRIME 研究的數據，支持我們批准 FOLFOX 一線用於轉移性結直腸癌。

And we terminated our Trebananib program directed against the angiopoietan axis in recurrent ovarian cancer, as well as our rilotumumab program directed against the MET axis in gastric cancer due to disappointing results.

由於結果令人失望，我們終止了針對複發性卵巢癌血管生成軸的 Trebananib 計劃，以及針對胃癌 MET 軸的利妥木單抗計劃。

Our recently announced collaboration with Kite Pharma on CAR-T cell technology complements our existing BiTE and oncolytic virus platforms broadening our overall immunotherapy capabilities.

我們最近宣布與 Kite Pharma 在 CAR-T 細胞技術方面的合作補充了我們現有的 BiTE 和溶瘤病毒平台，擴大了我們的整體免疫治療能力。

We have a very robust antigen discovery program at Amgen and the Kite collaboration provides another modality we can employ against these targets in both liquid and solid tumors.

我們在 Amgen 有一個非常強大的抗原發現計劃，與 Kite 的合作提供了另一種方式，我們可以在液體和實體腫瘤中針對這些目標使用。

Our biosimilars programs are advancing with Phase III data for our Humira biosimilar in moderate to severe rheumatoid arthritis, expected this quarter, and Phase III data for our Avastin biosimilar in advanced non-small-cell lung cancer, expected in the second half of this year.

我們的生物仿製藥計劃正在推進中度至重度類風濕性關節炎的 Humira 生物仿製藥的 III 期數據，預計本季度，以及我們的晚期非小細胞肺癌的 Avastin 生物仿製藥的 III 期數據，預計今年下半年.

Finally I'd like to recognize the strong execution of the R&D organization in delivering for patients.

最後，我想表彰研發組織在為患者提供服務方面的強大執行力。

2014 was an unprecedented year for Amgen in terms of the volume of pivotal data and regulatory submissions with multiple clinical and regulatory milestones ahead of us in 2015.

2014 年對於安進來說是前所未有的一年，在關鍵數據和監管提交的數量方面，我們在 2015 年取得了多項臨床和監管里程碑。

Bob?

鮑勃？

Okay thank you, Sean.

好的，謝謝你，肖恩。

All right, Marvin, I think we are ready for Q&A if you would like to remind our callers of the process for the question-and-answer session, please.

好的，馬文，我想我們已經準備好進行問答了，如果你想提醒我們的來電者問答環節的流程，請。

(Operator Instructions).

（操作員說明）。

Matthew Harrison, Morgan Stanley

馬修哈里森，摩根士丹利

Great, everyone thanks for taking the question.

太好了，謝謝大家提出問題。

So, I have two things I want to ask.

所以，我有兩件事想問。

First on Neupogen, I think in the past you've talked about having single-digit share, it sounds like it's double digits and if I look back on some of the other quarters where you have given us unit growth, the second and third quarter you were down maybe 7 to 8 percentage points in unit growth and you have grown to 11.

首先在 Neupogen 上，我認為過去你曾談論過擁有個位數的份額，這聽起來像是兩位數，如果我回顧一下你給我們單位增長的其他一些季度，第二和第三季度你的單位增長可能下降了 7 到 8 個百分點，現在你已經增長到 11 個百分點。

So I am just wondering what's happening there?

所以我只是想知道那裡發生了什麼？

Are you seeing additional traction from competitors?

您是否看到來自競爭對手的額外吸引力？

And separately, can you just comment a little bit on FX?

另外，您能否對 FX 發表一些評論？

I know you're keeping your guidance in light of increasing FX, just walk us through from a top line and bottom line perspective any hedging that you do and any offsets that you have there.

我知道你會根據不斷增加的外匯保持你的指導，只需從頂線和底線的角度向我們介紹你所做的任何對沖以及你在那裡擁有的任何抵消。

Thanks.

謝謝。

Okay sure Matt, why don't we take that two-part question in two parts.

好吧，馬特，為什麼我們不把這個由兩部分組成的問題分成兩部分。

We will start with Tony and then David can answer your FX question.

我們將從托尼開始，然後大衛可以回答您的外匯問題。

This is Tony.

這是托尼。

Some of the discussions we had in the past have referred to Granix's market share as a percentage of the overall Filgrastim market which was in the low single digits.

我們過去進行的一些討論提到 Granix 的市場份額佔整個非格司亭市場的百分比處於較低的個位數。

This quarter we have actually split it out for you, both the short acting and long-acting, so there's been no dramatic change in the fourth quarter.

這個季度我們實際上已經給你們分開了，包括短片和長片，所以第四季度沒有太大的變化。

The same trend has continued as we've seen throughout the year.

正如我們全年看到的那樣，同樣的趨勢仍在繼續。

And the FX David?

FX 大衛呢？

Sure.

當然。

So framing the FX question, a couple of context points.

因此，在構建 FX 問題時，有幾個上下文要點。

One is Amgen has about 75% of its sales currently are in the US and 25% are non-US, so vis-a-vis other global companies we have a relatively more limited level of exposure.

一是安進公司目前約有 75% 的銷售額在美國，25% 在美國以外，因此與其他全球公司相比，我們的風險敞口相對有限。

Secondly we have a three-year rolling hedge program so we're able to significantly offset in the short-term, foreign exchange movements either plus or minus.

其次，我們有一個為期三年的滾動對沖計劃，因此我們能夠在短期內顯著抵消外彙的正負波動。

If you then look at where we are in terms of rates on a current basis, if you look at the year-over-year effect on revenue if we were to stay at the current exchange rates through the balance of 2015, that would have about a $250 million impact unfavorable year over year so about 1 percentage point on revenue.

如果你看看我們在當前基礎上的匯率，如果你看看我們在 2015 年剩餘時間裡保持當前匯率對收入的同比影響，那將有大約2.5 億美元的影響同比不利，因此收入下降約 1 個百分點。

And about $0.05 a share versus what we've given as our original guidance.

與我們最初給出的指導相比，每股約 0.05 美元。

So with that in mind we felt that it would be appropriate, given the range that we are working with and other developments, that we felt it appropriate to maintain our existing guidance despite those potential headwinds.

因此，考慮到這一點，我們認為考慮到我們正在處理的範圍和其他事態發展，我們認為儘管存在這些潛在的不利因素，但維持我們現有的指導方針是適當的。

Mark Schoenebaum, Evercore ISI

Mark Schoenebaum，Evercore ISI

Hi guys, thanks a lot for taking my question.

大家好，非常感謝您提出我的問題。

If I might for Sean on the migraine antibody 334, I noticed during the prepared comments you said you thought you may have a better dosing interval or schedule than competitors.

如果我可能會為 Sean 推薦偏頭痛抗體 334，我注意到在準備好的評論中你說你認為你可能有比競爭對手更好的給藥間隔或時間表。

I think Teva -- that are targeting the ligand -- and I think Teva also has a Q-monthly dose ongoing.

我認為 Teva——針對配體——我認為 Teva 也正在進行 Q 月劑量。

So I was wondering maybe if you could expand on your rationale for that statement if possible Sean, please?

所以我想知道，如果可能的話，肖恩，你是否可以擴展你對那句話的理由？

And then also the filing strategy for that molecule, can you discuss what the FDA requires for episodic versus chronic if those need to be linked in the filing or if you think you can do it separately.

然後還有該分子的備案策略，如果需要在備案中鏈接或者您認為可以單獨進行，您能否討論 FDA 對間歇性和慢性的要求。

Thanks so much

非常感謝

I think, I don't know the details of course of the Teva program beyond what's in the public domain, but the bottom line is it's just the science here is very clear in terms of the relative potency of these approaches.

我想，除了公共領域之外，我不知道 Teva 計劃的課程細節，但底線是，就這些方法的相對效力而言，這裡的科學非常清楚。

And this has been true kind of on first principles, it is true in animal models, we're seeing the same thing in clinic.

這在第一原則上是正確的，在動物模型中也是如此，我們在臨床上也看到了同樣的事情。

So it's likely that that is difficult to overcome, a receptor antagonist is just a more efficient and potent way to address this particular biology.

所以這很可能很難克服，受體拮抗劑只是解決這種特殊生物學問題的一種更有效和更有效的方法。

And I think that will translate into situation where the amount of drug that has to be administered, presumably subcutaneously, will be an issue for the clinical approach profiles and I expect us to have the most favorable profile with respect to that just basically on those principles.

我認為這將轉化為必須給藥的情況，大概是皮下給藥，這將成為臨床方法概況的一個問題，我希望我們基本上根據這些原則在這方面擁有最有利的概況.

We'll see how it plays out, but that's what I would expect.

我們將看看結果如何，但這正是我所期望的。

We haven't had our end of Phase II discussions with the agencies yet.

我們還沒有結束與各機構的第二階段討論。

We just consolidated quite recently.

我們最近剛剛合併。

It's clear that both episodic and chronic migraine are separate regulatory entities in that you can have an approval, for example Botox is approved in chronic and not in episodic; you can have separate approvals.

很明顯，發作性偏頭痛和慢性偏頭痛都是獨立的監管實體，您可以獲得批准，例如保妥適被批准用於慢性而不是發作性；你可以有單獨的批准。

Whether the programs can be prosecuted together with some kind of efficiencies and how to coordinate those activities is something that we will be exploring with regulators.

這些項目是否可以與某種效率一起被起訴，以及如何協調這些活動是我們將與監管機構探討的問題。

So it's a good question we just don't have the advice from those type of interactions yet.

所以這是一個很好的問題，我們只是還沒有從這些類型的互動中得到建議。

Eric Schmidt with Cowen and Company

埃里克·施密特與 Cowen and Company

Thanks for taking my question.

感謝您提出我的問題。

Another one for Sean, it sounds like you are getting fairly deep in the FDA review process for Corlanor, T-VEC, and even Repatha.

Sean 的另一個問題，聽起來您在 FDA 對 Corlanor、T-VEC 甚至 Repatha 的審查過程中越來越深入。

Have you been informed for any of those three molecules that you'll need an ad comm prior to approval?

您是否被告知這三種分子中的任何一種在批准之前需要廣告傳播？

We had discussions with the agencies about the possibilities of ad comms, generally speaking when you are doing innovative new mechanism work in the United States the default would typically be to have them.

我們與代理商討論了廣告傳播的可能性，一般來說，當您在美國進行創新的新機制工作時，默認情況下通常會擁有它們。

But we always agree with the agency not to disclose anything about their intentions until they are in the federal register so we can't comment on the direction they are going with those right now.

但我們始終同意該機構在他們進入聯邦登記冊之前不要透露任何有關他們意圖的信息，因此我們現在無法評論他們的發展方向。

Thanks.

謝謝。

Michael Yee, RBC Capital Markets

Michael Yee，加拿大皇家銀行資本市場

Thanks for the question.

謝謝你的問題。

Obviously topical on mind is a lot of context around pricing and what managed care is doing these days.

顯然，腦海中的話題是很多關於定價的背景以及這些天管理式醫療正在做什麼。

So to the extent you have a multibillion-dollar product in the future, maybe you could comment to us on how discussions with payers works with that type of molecule, pre-outcomes versus post outcomes and so-called value or not value of so-called exclusive contracts.

因此，就未來您擁有數十億美元的產品而言，也許您可以向我們評論與付款人的討論如何處理這種類型的分子，結果前與結果後以及所謂的價值或非價值 -稱為獨家合同。

Maybe you can offer some perspective around those debates?

也許您可以圍繞這些辯論提供一些觀點？

Thanks Michael Tony will address that question.

謝謝邁克爾托尼將解決這個問題。

Michael, so Amgen sees both payers and providers as being essential parts of our customer base and we interact with them on a daily basis both about our products and about the contracts with our products.

邁克爾，所以安進將付款人和提供者視為我們客戶群的重要組成部分，我們每天都與他們就我們的產品以及與我們的產品簽訂的合同進行互動。

The payers often request information about Amgen's investigational products in anticipation of upcoming launches so they can make coverage decisions.

付款人經常要求提供有關安進（Amgen）研究產品的信息，以期待即將推出的產品，以便他們做出承保決定。

In these situations appropriate personnel from our medical team respond to the inquiries in a balanced, scientifically rigorous manner consistent with the FDA guidance.

在這些情況下，我們醫療團隊的適當人員會以符合 FDA 指南的平衡、科學嚴謹的方式回應詢問。

Terence Flynn, Goldman Sachs

特倫斯弗林，高盛

Hi, how are you doing?

嗨，你好嗎？

Maybe just one for me, it's a two-part question.

也許對我來說只有一個，這是一個由兩部分組成的問題。

Just wonder if you can offer your perspectives on the bar for interchangeability following the FDA panel on the biosimilar Neupogen product earlier this month?

只是想知道在本月早些時候 FDA 小組對生物仿製藥 Neupogen 產品進行調查後，您是否可以就互換性的標準提出您的看法？

And wondering if that's something you'd pursue for your drugs?

想知道這是否是您為藥物所追求的東西？

And then any thoughts on indication extrapolation for both Humira and Avastin, your biosimilars, and what can you tell us there?

然後關於 Humira 和 Avastin 的適應症外推的任何想法，你的生物仿製藥，你能告訴我們什麼？

Thanks.

謝謝。

Okay thanks Terrence.

好的，謝謝泰倫斯。

Sean, why don't you get those questions.

肖恩，你為什麼不問這些問題。

I think the interchangeability in the United States is clearly going to take a little bit longer than achieving biosimilarity through a regulatory process and the agency has been pretty clear about that.

我認為美國的可互換性顯然比通過監管程序實現生物相似性需要更長的時間，該機構對此非常清楚。

I think that all companies, including us, will of course seek to have that kind of status for the product.

我認為包括我們在內的所有公司當然都會尋求產品的這種地位。

It's just a question of what are the rules and guidance and how onerous is it to go through the process of trying to achieve that.

問題只是規則和指導是什麼，以及嘗試實現這一目標的過程有多繁重。

The indication extrapolation is something that we do expect to be the general rule.

指示外推是我們確實希望成為一般規則的東西。

There may be exceptions to it but we found generally in Europe that it was the way that things shook out and it is a reasonably scientifically sound concepts to have extrapolation across indications.

它可能有例外，但我們在歐洲普遍發現，這是事情發生變化的方式，並且跨適應症進行外推是一個合理的科學合理的概念。

But sometimes there are indications in which the pharmokinetic exposure response relationship is not as clear and in those cases some additional data can be required.

但有時有跡象表明藥代動力學暴露反應關係並不明確，在這些情況下可能需要一些額外的數據。

Robyn Karnauskas, Deutsche Bank

Robyn Karnauskas，德意志銀行

Robyn are you there?

羅賓你在嗎？

Yes I'm so sorry.

是的，我很抱歉。

I am very glad you are not hearing, let it go, because I muted the phone on my daughter singing, Let it go.

我很高興你沒有聽到，放手吧，因為我在女兒唱歌時把電話靜音了，放手吧。

I apologize.

我道歉。

[Laughter] We've all heard that.

[笑聲] 我們都聽說過。

No problem.

沒問題。

Go ahead.

前進。

So one housekeeping.

所以一個家政服務。

Is PCSK9 included in your guidance and how do we think about Enbrel given the call you gave going to fourth quarter?

PCSK9 是否包含在您的指導中？鑑於您在第四季度的電話會議，我們如何看待 Enbrel？

And the big picture question for biosimilars.

以及生物仿製藥的大局問題。

There was a company discussing how you haven't had IP around your Humira drug and manufacturing process and that could hurt you on the filing against Abbvie during the 180 day period where you -- they could assert their IP.

有一家公司討論你如何沒有圍繞你的 Humira 藥物和製造過程的知識產權，這可能會在你可以主張他們的知識產權的 180 天期限內傷害你對 Abbvie 的備案。

How do we think about your filing time lines for Humira and how you decide to protect yourself against filing against the formulation?

我們如何看待您為 Humira 提交申請的時間表，以及您如何決定保護自己免於提交針對該製劑的申請？

Thanks.

謝謝。

Lots of questions in there, Robyn.

羅賓，裡面有很多問題。

Let's see whether we can get those.

讓我們看看我們是否能得到那些。

First is PCSK9 included in our outlook for the year?

首先，PCSK9 是否包含在我們今年的展望中？

Yes it is.

是的。

Second, I wasn't clear what you were asking for on Enbrel, can you rephrase the question?

其次，我不清楚你對 Enbrel 的要求是什麼，你能改一下這個問題嗎？

You said how should we think about Enbrel given the guidance we gave from the fourth quarter, is that right Robyn?

你說根據我們從第四季度開始給出的指導，我們應該如何看待 Enbrel，是嗎 Robyn？

Robyn, did we lose you again?

羅賓，我們又失去你了嗎？

(Operator Instructions)

（操作員說明）

By our math Enbrel sales were positively impacted about $200 million this quarter for inventory, so where does the inventory stand for Enbrel versus normal ranges.

根據我們的計算，本季度 Enbrel 的銷售額對庫存產生了約 2 億美元的積極影響，那麼 Enbrel 的庫存與正常範圍相比處於什麼水平。

That's what I was asking about for the year.

這就是我今年要問的問題。

Okay.

好的。

So let me answer that one Robyn, it's Tony.

所以讓我回答那個羅賓，是托尼。

As I said, we think there's about $40 million of additional inventory that happened in the fourth quarter and that $40 million will work its way out of the first quarter but we continue to have very positive views on Enbrel through 2015.

正如我所說，我們認為第四季度發生了大約 4000 萬美元的額外庫存，這 4000 萬美元將在第一季度結束，但我們對 Enbrel 的看法在 2015 年之前仍然非常樂觀。

With respect to our biosimilar program for Humira and the other molecules that we're seeking to advance.

關於我們針對 Humira 和我們正在尋求推進的其他分子的生物仿製藥計劃。

The other eight molecules, we are obviously very attentive to the intellectual property and the statutes that exist to enable us to advance the biosimilar program, and you should expect we'll be compliant with those statutes and we provided the guidance that we think we'll be launching our first biosimilar by 2017.

其他八個分子，我們顯然非常關注知識產權和現有法規，使我們能夠推進生物仿製藥計劃，你應該期望我們會遵守這些法規，我們提供了我們認為我們的指導'到 2017 年將推出我們的第一個生物仿製藥。

Does that mean you will file ahead?

這是否意味著您將提前提交？

Thank you, sorry.

謝謝，對不起。

Let's take the next question please.

請讓我們回答下一個問題。

Ying Huang, Bank of America

Ying Huang，美國銀行

Thanks for taking my question.

感謝您提出我的問題。

First one is, to what extent does your 2015 guidance bake in the potential biosimilar competition for Neupogen?

第一個是，您的 2015 年指南在多大程度上影響了 Neupogen 的潛在生物仿製藥競爭？

And then will your litigation against Novartis Sandoz delay or even prevent marketing of Zarxio?

那麼你們對諾華山德士的訴訟是否會延遲甚至阻止 Zarxio 的營銷？

And then another question is for your PCSK9 Evolocumab, during your discussion with the payers would you actually go down the path of pursuing exclusive formulary against the other payer?

然後另一個問題是關於你的 PCSK9 Evolocumab，在你與付款人的討論中，你真的會走上尋求針對其他付款人的獨家處方的道路嗎？

Thank you.

謝謝你。

Let's take that in 2 parts.

讓我們把它分成兩部分。

Why don't I take the first part.

為什麼我不參加第一部分。

Our 2015 guidance includes our expectations across the product portfolio including the prospect of competition for Neupogen.

我們的 2015 年指南包括我們對整個產品組合的預期，包括 Neupogen 的競爭前景。

With respect to your specific question about the lawsuit versus Novartis and Sandoz, their subsidiary Sandoz, we're not going to speculate on the outcome of that litigation, as you know that's going to make its way through the courts.

關於您針對諾華和山德士及其子公司山德士提起的訴訟的具體問題，我們不會推測該訴訟的結果，因為您知道這將通過法庭審理。

And Tony if you want to address the PCSK9?

托尼，如果你想解決 PCSK9 問題？

I mean, I don't think we're going to be talking about our rebating strategy or contracting strategy at this particular stage.

我的意思是，我認為我們不會在這個特定階段談論我們的回扣策略或合同策略。

We come to market with a drug that has a unique and definitive value proposition.

我們將一種具有獨特和明確價值主張的藥物推向市場。

We'll price it accordingly and obviously the rebating contracts are essential to get a preferred position on the formulary.

我們會相應地定價，顯然，回扣合同對於在處方集上獲得優先地位至關重要。

Marvin, let's take the next question, but before you do, I would like to request that everybody limit themselves to one question just to be sure we can get through with everybody that's lined up.

Marvin，讓我們來回答下一個問題，但在你開始之前，我想請大家將自己限制在一個問題上，以確保我們能夠與排隊的每個人一起討論。

Let's go ahead with the next question, please.

請繼續下一個問題。

Geoffrey Porges, Bernstein

杰弗裡·波赫斯，伯恩斯坦

The question, David, could you just comment on your tax rate guidance?

問題是，戴維，你能評論一下你的稅率指導嗎？

For the last 2 years you've kind of had a windfall in the fourth quarter from the reinstatement of the R&D tax credit.

在過去的兩年裡，你在第四季度從恢復研發稅收抵免中獲得了一筆意外之財。

Could you give us a sense of what your full-year tax rate guidance would be if we assume that the R&D tax credit was indeed reinstated?

如果我們假設研發稅收抵免確實恢復了，您能否告訴我們您的全年稅率指導是什麼？

Sure.

當然。

So, if you look at the impact on an annual basis of the R&D tax credit it's about 1 percentage point for Amgen, so hence this quarter the gross positive impact was about four points which then netted to 2 1/2 points as I mentioned in the call.

所以，如果你看一下研發稅收抵免每年的影響，它對安進公司來說大約是 1 個百分點，因此本季度的總積極影響大約是 4 個百分點，然後達到 2 1/2 個百分點，正如我在電話。

But I think at from a planning perspective we said 18% to 19% for 2015 ex-R&D, so that would be 1 point less if the R&D credit were to be approved again this year.

但我認為，從規劃的角度來看，我們說 2015 年不包括研發的比例為 18% 至 19%，因此如果今年再次批准研發信貸，這將減少 1 個百分點。

Thanks very much.

非常感謝。

Matt Roden, UBS

馬特·羅登，瑞銀

Great, thanks very much for taking the question.

太好了，非常感謝您提出這個問題。

Tony you mentioned your confidence in Enbrel outlook for 2015.

托尼，你提到了你對 Enbrel 2015 年前景的信心。

Can you talk a little bit about the dermatology and rheumatology market share, where it stands, how it's changed on a year-on-year basis, and how you would expect Enbrel could be potentially impacted by the IL-17 launching in derm.

你能談談皮膚病學和風濕病學的市場份額，它的現狀，它是如何逐年變化的，以及你如何預期 Enbrel 可能會受到 IL-17 在皮膚中的推出的潛在影響。

Okay.

好的。

Sure.

當然。

As you've seen over the last couple of years the market continues to grow double digit, Enbrel has been losing market share in both rheumatology and dermatology.

正如您在過去幾年中看到的那樣，市場繼續以兩位數增長，Enbrel 在風濕病學和皮膚病學領域的市場份額一直在下降。

From an actual unit perspective we continue to show positive year end growth and we're in a position to drive some of the pricing in the marketplace.

從實際單位的角度來看，我們繼續顯示出積極的年終增長，並且我們能夠推動市場上的一些定價。

From a derm perspective we take all competition seriously.

從皮膚的角度來看，我們認真對待所有競爭。

But Enbrel, as you know, has been in the market for 13 years now, and when you are treating psoriasis it's a long-term chronic disease; and then both efficacy and safety are important for patients.

但是如您所知，Enbrel 已經上市 13 年了，當您治療牛皮癬時，它是一種長期慢性疾病；然後療效和安全性對患者都很重要。

And patients do switch backwards and forwards.

患者確實會來回切換。

So we continue to see a clear place for Enbrel in the marketplace in spite of the new competition.

因此，儘管存在新的競爭，我們仍繼續看到 Enbrel 在市場上的明確位置。

Cory Kasimov JPMorgan

科里卡西莫夫摩根大通

Good afternoon guys and thanks for taking my question.

大家下午好，謝謝你提出我的問題。

Following up on this Derm subject, this morning we heard Novartis talk a lot, at least relatively speaking, about the potential of Cosentix and the IL-17 pathway.

繼這個 Derm 主題之後，今天早上我們聽到 Novartis 談論了很多，至少相對而言，是關於 Cosentix 和 IL-17 通路的潛力。

So can you remind us of the differences you see between it and Brodalumab and how you see that competitive dynamic playing out there?

那麼，您能否提醒我們您所看到的它與 Brodalumab 之間的差異，以及您如何看待那裡的競爭動態？

Thanks.

謝謝。

Sean, why don't you field that question.

肖恩，你為什麼不回答這個問題。

I think that the data that we generated with Brodalumab will be included in our filing, both head-to-head to Stelara and in placebo-controlled trials, have generated the best skin clearance data that has existed for any agent that has been tested in the disease.

我認為我們使用 Brodalumab 生成的數據將包含在我們的文件中，無論是與 Stelara 的頭對頭試驗還是在安慰劑對照試驗中，都產生了最好的皮膚清除數據，這些數據已經存在於任何已經過測試的藥物中這種病。

Now that said, we don't obviously have head-to-head data against the other IL-17 molecules.

話雖如此，我們顯然沒有針對其他 IL-17 分子的直接數據。

But I think that the general impression that the experts in the field that look at the data sets have, is that the efficacy of Brodalumab is unmatched in the class so far with the data that's been generated.

但我認為，查看數據集的該領域專家的一般印像是，到目前為止，Brodalumab 的療效在同類產品中是無與倫比的。

So I think that's probably the key kind of differentiating.

所以我認為這可能是差異化的關鍵。

Remember this, of course, is a receptor blocking antibody rather than a ligand sequestering.

請記住，這當然是一種受體阻斷抗體，而不是配體螯合。

We know there are multiple ligands for the receptor so it is possible that one would see differences in efficacy.

我們知道受體有多種配體，因此人們可能會看到療效差異。

That was always our hope was that this would be the most efficacious approach to this particular axis.

我們一直希望這將是處理這個特定軸的最有效方法。

So, we'll have to get all of our data packaged together into a label and obviously, Tony could talk about the competitive environment.

因此，我們必須將所有數據打包到一個標籤中，顯然，Tony 可以談論競爭環境。

But my sense is there may be some differentiation largely on efficacy.

但我的感覺是，主要在功效上可能存在一些差異。

I think we'll see once we see the labels of all products in the marketplace.

我想我們會看到市場上所有產品的標籤。

Yaron Werber with Citi.

Yaron Werber 與花旗銀行。

Thanks for taking my question.

感謝您提出我的問題。

I have a question sort of on the EPO franchise.

我有一個關於 EPO 特許經營權的問題。

Roche is now currently testing Mircera at various clinics, sort of what Affymax did back in the days, and Hospira just filed their generic EPO for approval.

羅氏目前正在各個診所測試 Mircera，有點像 Affymax 過去所做的，而 Hospira 剛剛提交了他們的通用 EPO 以供批准。

So can you just remind us your agreement with DaVita does it, if I remember correctly, guarantees them the best price in the market for EPO based on share for 2018?

那麼，您能否提醒我們，如果我沒記錯的話，您與 DaVita 達成的協議是否可以保證他們在 2018 年基於股票獲得 EPO 市場上最優惠的價格？

If you don't mind refreshing us on that.

如果您不介意讓我們對此耳目一新。

And then just your thoughts on what happens for biosimilars when you're looking at two different indications like CKD dialysis and oncology?

然後，當您查看兩種不同的適應症（如 CKD 透析和腫瘤學）時，您對生物仿製藥會發生什麼的想法？

Is that something they can get a single label across all three diseases?

他們可以在所有三種疾病上獲得一個單一的標籤嗎？

Thank you.

謝謝你。

Let me answer those questions one by one and probably have Sean take the last one.

讓我一一回答這些問題，可能讓肖恩回答最後一個問題。

From a contract perspective we haven't made the details of our contract with DaVita public but the contract is an exclusive contract which extends to 2018.

從合同的角度來看，我們還沒有公開我們與 DaVita 的合同細節，但該合同是一份延長至 2018 年的排他性合同。

As regards to Mircera, we understand from public statements that Roche has said that they have made the product commercially available.

關於 Mircera，我們從公開聲明中了解到，羅氏表示他們已經將該產品推向市場。

We have not seen any impact on our business yet as regards to Mircera entry to the marketplace.

關於 Mircera 進入市場，我們還沒有看到對我們的業務有任何影響。

Sean?

肖恩？

Again, it will differ case-by-case by different molecules, what the agency holds as the approval standards.

同樣，它會因不同的分子而異，該機構將其視為批准標準。

In general again, the default would be indication extrapolation but it won't be true in all circumstances.

一般而言，默認值是指示外推，但並非在所有情況下都是如此。

Josh Schimmer, Piper Jaffray

喬什·席默，派珀·杰弗瑞

Thanks for taking the questions.

感謝您提出問題。

I was hoping you could discuss the expected cadence of adoption and eventual penetration levels you would be looking for the new Neulasta auto-injector and for Corlanor into their respective markets.

我希望您能討論您將尋找新的 Neulasta 自動注射器和 Corlanor 進入各自市場的預期採用節奏和最終滲透水平。

Thanks.

謝謝。

On-body injector.

身體注射器。

He's asking the penetration for the on- body injector for Neulasta.

他正在詢問 Neulasta 身上註射器的滲透率。

And then for Corlanor penetration.

然後進行 Corlanor 滲透。

Let me take those two together.

讓我把這兩個放在一起。

As we look at the marketplace we know that there are a number of patients that really struggle to come back for injections of Neulasta post-chemo, including patients who received drug on a Friday.

當我們審視市場時，我們知道有很多患者在化療後很難回來注射 Neulasta，包括週五接受藥物治療的患者。

We estimate, I think, patients get in the region of about 4.4 cycles per chemo, which is way beyond what it should be.

我認為，我們估計患者每次化療大約需要 4.4 個週期，這遠遠超出了應有的範圍。

So it's a fairly large group of patients who'll benefit definitively from access to the on-body injector.

因此，有相當大的患者群體將從使用身上註射器中獲益。

We'll be launching this in the not-too-distant future and be looking to switch as much of the business as possible to the injector.

我們將在不久的將來推出此產品，並希望將盡可能多的業務轉移到噴油器上。

When I think about Corlanor -- Corlanor, as you know, is an interesting product that will be used as an add-on to existing standard of care.

當我想到 Corlanor 時——如您所知，Corlanor 是一種有趣的產品，將用作現有護理標準的附加產品。

Irrespective of what the standard of care is, the product will augment the value and help manage patients with heart failure.

無論護理標準是什麼，該產品都將增加價值並幫助管理心力衰竭患者。

We know exactly where the heart failure clinics are and we know how large the unmet medical need is.

我們確切地知道心力衰竭診所在哪裡，我們知道未滿足的醫療需求有多大。

The cardiovascular teams that are presently in place are busy segmenting the market as we speak.

在我們說話的時候，目前就位的心血管團隊正忙於細分市場。

Geoff Meacham Barclays

傑夫·米查姆·巴克萊銀行

Hi guys, thanks so much for taking the question.

大家好，非常感謝您提出這個問題。

Sean, I have a couple related ones on Kyprolis.

肖恩，我在 Kyprolis 上有幾個相關的。

When you look beyond the label expansion, would you say that ENDEAVOR represents the next inflection point for the product?

當您超越標籤擴展時，您會說 ENDEAVOR 代表了產品的下一個拐點嗎？

And does recent data at the ASH meeting change your view on the hurdle for that study or other head-to-head studies?

ASH 會議上的最新數據是否會改變您對該研究或其他頭對頭研究的障礙的看法？

Thank you

謝謝

ASPIRE was of course really an important study for the molecule in and of itself and it performed as well as we could reasonably expect.

ASPIRE 當然是對分子本身的一項重要研究，它的表現和我們合理預期的一樣好。

Always the question has been, how they compare head-to-head to Velcade and I think it never will be the first example of that question.

一直以來的問題是，他們如何與 Velcade 進行直接比較，我認為它永遠不會成為該問題的第一個例子。

And then of course we'll see CLARION which will look at that same question in the first-line setting.

然後我們當然會看到 CLARION，它將在第一線設置中查看相同的問題。

I think we continue to have the same point of view that we've had since we acquired Onyx, and even before we acquired Onyx, is that we believe that Kyprolis is the best in class proteosome inhibitor and so we are looking forward to seeing the results of these studies over time.

我認為，自從我們收購 Onyx 以來，甚至在我們收購 Onyx 之前，我們仍然持有相同的觀點，即我們相信 Kyprolis 是同類中最好的蛋白體抑製劑，因此我們期待看到隨著時間的推移，這些研究的結果。

Thank you.

謝謝你。

Chris Raymond, Robert Baird and Company

克里斯·雷蒙德、羅伯特·貝爾德公司

Thanks.

謝謝。

Wanted to just expand a little bit on your comments to an earlier question on the ESA franchise and specifically on EPO.

想稍微擴展一下您對之前關於 ESA 專營權，特別是 EPO 的問題的評論。

I know you guys have talked pretty openly about the Fresenius pilot program going on right now.

我知道你們已經非常公開地談論了費森尤斯目前正在進行的試點項目。

But it seems from what they are saying that they are moving on pretty quickly here.

但從他們所說的看來，他們在這裡進展得相當快。

I can't imagine you'd want to talk about specific customer discussions, but given that they're such a big player in the US, I wonder if you could frame the situation for us.

我無法想像你會想談論具體的客戶討論，但鑑於他們在美國是一個如此大的參與者，我想知道你是否可以為我們描述一下情況。

I know it's probably within the realm of your guidance but, come July 1 is there any scenario perhaps where you might want to revisit what your thinking is on Epo and just put some brackets around the range of outcomes here.

我知道這可能在您的指導範圍內，但是，7 月 1 日到來時，您是否可能想要重新審視您對 Epo 的想法，並在此處為結果範圍加上一些括號。

Thanks

謝謝

This is Tony.

這是托尼。

The guidance we gave in October included the knowledge that Mircera will be coming to market.

我們在 10 月份給出的指導包括 Mircera 將上市的信息。

We have competed with Mircera in the European market now for about 5 years and they hold between 8% and 10% of the marketplace.

我們已經在歐洲市場與 Mircera 競爭了大約 5 年，他們佔據了 8% 到 10% 的市場份額。

As I said we saw no impact yet at all our business in the fourth quarter of 2014.

正如我所說，我們在 2014 年第四季度的所有業務中都沒有看到任何影響。

Eun Yang, Jefferies

恩陽傑富瑞

In 2011 you guys expected total Denosumab sales to be around $3 billion to $4 billion in 2015 and current sales and run rate are tracking below $3 billion, so can you comment on what changed sort of your vision or expectation?

2011 年，你們預計 2015 年狄諾塞麥的總銷售額約為 30 億至 40 億美元，而目前的銷售額和運行率低於 30 億美元，那麼您能否評論一下是什麼改變了您的願景或期望？

Sure we'll take it in 2 parts, Eun.

當然，我們會把它分成兩部分，Eun。

Obviously, as you know, we are pleased with the progress we are making with Denosumab both in the Prolia setting for osteoporosisand of course Xgeva in oncology.

顯然，如您所知，我們對我們在 Prolia 治療骨質疏鬆症和 Xgeva 在腫瘤學方面取得的進展感到滿意。

I think the international pricing took longer than we thought for Prolia.

我認為國際定價比我們為 Prolia 想像的要長。

So if anything has changed since the original guidance it was that, but fundamentally we still think this is going to be a big product and its continues to grow the way Tony described.

因此，如果自最初的指導以來有任何變化，那就是，但從根本上說，我們仍然認為這將是一個大產品，並且它將繼續按照托尼描述的方式增長。

Tony, I will invite you to elaborate on the outlook for Prolia and Xgeva from there.

托尼，我將邀請你從那裡詳細闡述 Prolia 和 Xgeva 的前景。

As we continue to watch the marketplace and look at the new naive or bio naive patients, our market share on new patients is to drive consistently continually higher than our normal TRx share.

隨著我們繼續關注市場並關注新的天真或生物天真患者，我們在新患者上的市場份額將持續不斷地高於我們正常的 TRx 份額。

We see our share of new patients at about 30% of the market and our actual in market share of about 19% in the US.

我們看到我們的新患者份額約佔市場的 30%，而我們在美國的實際市場份額約為 19%。

So as you extrapolate those two, there continues to be room for growth as these patients move in and get their second and third injections.

因此，當您推斷這兩者時，隨著這些患者進入並進行第二次和第三次注射，仍有增長空間。

Furthermore the long-term safety and efficacy data continue to be very encouraging for the product, so we continue to think this is a source of growth in the way we outlined earlier in the call.

此外，長期安全性和有效性數據繼續對該產品非常鼓舞人心，因此我們繼續認為這是我們在電話會議早些時候概述的方式的增長來源。

We now have our eighth year of safety data in the label, just confirming what Bob just said.

我們現在在標籤中有第八年的安全數據，只是證實了 Bob 剛才說的話。

Ravi Mehrotra.

拉維梅赫羅特拉。

Credit Suisse

瑞士信貸

Thanks for taking my question, which regards biosimilars.

感謝您回答我關於生物仿製藥的問題。

Given your relatively unique position as being both the hunter and prey, I would be very interested in your view on the defense mechanism of the originators from a regulatory and legal perspective.

鑑於你既是獵人又是獵物的相對獨特的地位，我很想知道你從監管和法律的角度對發起人的防禦機制的看法。

And then flipping that on its head, how your biosimilars programs could circumvent these defense mechanisms and link to that very specifically.

然後翻轉過來，你的生物仿製藥計劃如何規避這些防禦機制並非常具體地與之相關聯。

On Humira there's been a little bit of chatter on the frequency of dosing patterns that Abbvie has, your comments on that as a defense mechanism would be appreciated as well.

在 Humira 上，關於 Abbvie 的劑量模式頻率存在一些爭論，您也將對此作為一種防禦機制發表評論。

Ravi, I guess a couple points.

拉維，我想有幾點。

First we've said for some time we thought there was benefit for both our innovative products and our new potential biosimilar products that we participate in both aspects of the market.

首先，我們已經說過一段時間了，我們認為我們參與市場的兩個方面對我們的創新產品和新的潛在生物仿製藥產品都有好處。

So through time, what we have found is we continue to learn about our own innovative process development efforts et cetera by the virtue of the work we're doing in our biosimilars program.

因此，隨著時間的推移，我們發現，憑藉我們在生物仿製藥項目中所做的工作，我們繼續了解我們自己的創新工藝開發工作等。

I think our dialogue with the regulators around the world is enhanced by the fact we are recognized to be both an innovator and a Company that is seeking to advance biosimilar molecules; so we're continuing to work both sides of this.

我認為我們與世界各地監管機構的對話得到加強，因為我們被公認為既是創新者又是尋求推進生物仿製藥分子的公司；所以我們會繼續在這兩個方面努力。

As you know we have nine biosimilar molecules that are advancing successfully through the clinic and we continue to believe that this will be a large revenue opportunity for us.

如您所知，我們有九種生物仿製藥分子正在通過臨床成功推進，我們仍然相信這對我們來說將是一個巨大的收入機會。

So again, with respect to any individual program, the biosimilar to Humira in particular, as you know we generated positive Phase III data already.

因此，對於任何單個項目，特別是 Humira 的生物仿製藥，正如你所知，我們已經產生了積極的 III 期數據。

We added on this call that we expect another data set early in the year and we look forward to having all of that data and filing that as an attractive biosimilar alternative to proprietary adalimumab.

我們在這次電話會議上補充說，我們希望在今年年初獲得另一個數據集，我們期待獲得所有這些數據並將其作為專有阿達木單抗的有吸引力的生物仿製藥替代品進行備案。

We think we are in good shape there and we look forward to having the data and being able to file with the regulators.

我們認為我們在那里處於良好狀態，我們期待獲得數據並能夠向監管機構提交文件。

Marvin as we're going past the hour, why don't we take two more questions.

馬文，我們要過了一個小時，為什麼我們不再回答兩個問題。

Ian Somaiya, Nomura Securities

Ian Somaiya，野村證券

Thanks, just a question on the biosimilars, maybe more specifically on potential for interchangeability.

謝謝，只是關於生物仿製藥的問題，也許更具體地說是關於可互換性的潛力。

I think you had mentioned a couple of weeks ago that the FDA might require switch studies in the originator drug to the biosimilar drug to get comfortable immunogenecity and potential for immunogenecity.

我想你幾週前提到過，FDA 可能需要對原研藥進行生物仿製藥的轉換研究，以獲得舒適的免疫原性和潛在的免疫原性。

I was wondering if there any other clinical trial requirements that you feel the FDA could place before allowing a drug to get interchangeability.

我想知道在允許藥物獲得可互換性之前，您認為 FDA 是否可以提出任何其他臨床試驗要求。

This is Sean.

這是肖恩。

I think that the agency is still very much working internally on their thoughts about interchangeability.

我認為該機構仍在內部努力研究他們關於可互換性的想法。

That's the sense I have, they have not put out the same level of clear-written guidance that they have, for example, for achieving biosimilarity.

這就是我的感覺，他們沒有提出與他們所擁有的相同水平的清晰書面指導，例如，用於實現生物相似性。

I think they are in discussions about this with various sponsors.

我認為他們正在與各種贊助商討論這個問題。

And the switching issue is one that they have identified and that makes certain first principle sense.

轉換問題是他們已經確定的，這使得某些第一原則有意義。

It's hard for me to speculate really about what other requirements they might put in place beyond demonstrating that it is possible to switch patients back and forth between the agents without any untoward effects.

除了證明可以在患者之間來回切換藥物而不會產生任何不良影響之外，我很難真正推測他們可能提出的其他要求。

Howard Liang, Leerink

Howard Liang, Leerink

Thanks very much.

非常感謝。

I have a question on the proteasome inhibitor franchise.

我對蛋白酶體抑製劑專營權有疑問。

With regard Takeda's Ixazomib, my understanding is they will likely report data sometime this year.

關於武田的 Ixazomib，我的理解是他們可能會在今年某個時候報告數據。

How do you see it impact Kyprolis and then how you feel about your own oral protease inhibitor, Oprozomib?

您如何看待它對 Kyprolis 的影響，以及您對自己的口服蛋白酶抑製劑 Oprozomib 有何看法？

This is Sean.

這是肖恩。

I think we're interested in pursuing Oprozomib as an agent that may deliver a level of efficacy in a chronic maintenance setting, particularly that would be above and beyond what we are imagining is going to come from the Takeda product.

我認為我們有興趣將 Oprozomib 作為一種藥物，它可以在慢性維持環境中提供一定程度的療效，尤其是超出我們想像的武田產品的療效。

I think these are difficult molecules to develop, this oral molecules, because of the GI toxicities that can be associated with them; so there is dose limiting toxicity.

我認為這些是難以開發的分子，這種口服分子，因為可能與它們相關的 GI 毒性；所以存在劑量限制性毒性。

It can be difficult to manage around that.

圍繞這一點可能很難管理。

We're working on that problem.

我們正在解決這個問題。

Tony obviously would be the appropriate person to comment on the competitive environment.

托尼顯然是對競爭環境發表評論的合適人選。

When we think about multiple myeloma we are talking about a disease that patients will die from and they are facing -- every single physician and patient in the setting thinks about efficacy first and our belief and commitment to Kyprolis has been around the deep science of this product and we truly believe will be the best in class in this category.

當我們想到多發性骨髓瘤時，我們談論的是一種患者將死於並且他們正面臨的疾病——環境中的每一位醫生和患者都首先考慮療效，我們對 Kyprolis 的信念和承諾一直圍繞著這方面的深層科學產品，我們堅信將成為同類產品中最好的。

I think our ability based on the ASPIRE data and potentially other data coming to show the definitive improvement on progression-free survival with regimens including Kyprolis, stand us in very good stead to maintain a large part of the market.

我認為我們基於 ASPIRE 數據和其他潛在數據的能力表明，包括 Kyprolis 在內的方案對無進展生存期的明確改善，使我們能夠很好地維持大部分市場。

Excellent.

出色的。

Thank you Tony.

謝謝托尼。

I would like to thank all of you for your participation in our call this afternoon.

我要感謝大家今天下午參加我們的電話會議。

Of course, if you have any follow-up questions or comments the investor relations team will be standing by.

當然，如果您有任何後續問題或意見，投資者關係團隊將隨時待命。

Thanks again.

再次感謝。

Ladies and gentlemen this concludes Amgen's fourth-quarter and financial results conference call.

女士們，先生們，安進第四季度和財務業績電話會議到此結束。

You may now disconnect.

您現在可以斷開連接。