美國安進 (AMGN) 2013 Q4 法說會逐字稿

My name is Marvin, and I will be your conference facilitator today for Amgen's Fourth Quarter and Full Year 2013 Financial Results Conference Call.

我叫馬文，今天我將擔任安進公司 2013 年第四季度和全年財務業績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。

Thanks, Marvin, good afternoon everybody.

謝謝，馬文，大家下午好。

I would like to welcome you to our conference call to review our operating performance for the fourth quarter and full year 2013.

歡迎您參加我們的電話會議，回顧我們 2013 年第四季度和全年的經營業績。

We have accomplished a lot during 2013 on many fronts, including operational and strategic, and we are looking forward to delivering in 2014 a year which will be characterized by significant clinical data flow.

2013 年，我們在許多方面取得了很多成就，包括運營和戰略，我們期待著在 2014 年交付一個以重要的臨床數據流為特徵的一年。

Leading the call today will be our Chairman and CEO, Bob Bradway, who will provide a strategic report on our performance in 2013 and outlook for 2014.

我們的董事長兼首席執行官 Bob Bradway 將主持今天的電話會議，他將提供一份關於我們 2013 年業績和 2014 年展望的戰略報告。

We also have our Interim CFO, Michael Kelly, who will review our Q4 and full-year results and provide financial guidance for 2014.

我們還有臨時首席財務官 Michael Kelly，他將審查我們的第四季度和全年業績，並為 2014 年提供財務指導。

Tony Hooper, our Head of Global Commercial Operations, 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。

And finally, Sean Harper, our Head of R&D, will then outline the expected flow data for many of our pipeline products.

最後，我們的研發主管 Sean Harper 將概述我們許多管道產品的預期流量數據。

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。

These slides have been posted on our website, and a link was sent to you separately by e-mail.

這些幻燈片已張貼在我們的網站上，並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，通過我們今天的介紹和討論，我們可能會做出某些前瞻性陳述，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。

Bob?

鮑勃？

Okay, thank you, Arvind.

好的，謝謝你，阿文德。

I think confident is the best way to describe how we feel about our long-term growth prospects as we head into 2014.

我認為自信是描述我們在進入 2014 年時對長期增長前景的看法的最佳方式。

Our confidence is bolstered by our performance in 2013 on all fronts: financial, operational, and strategic.

2013 年我們在各方面的表現增強了我們的信心：財務、運營和戰略。

Financially in the fourth quarter, as you can see from our results, revenues were up 13%, and our earnings-per-share were up 30%.

在第四季度的財務上，正如您從我們的結果中看到的那樣，收入增長了 13%，我們的每股收益增長了 30%。

For the full-year, revenues were up 8%, and earnings-per-share up 17%, reflecting strong execution and continued momentum in our business.

全年收入增長 8%，每股收益增長 17%，反映了我們業務的強勁執行力和持續發展勢頭。

Geographically, we grew across all our markets.

從地理上講，我們在所有市場中都取得了增長。

We were strong in the US.

我們在美國很強大。

And once again this year, I believe we are one of the few companies growing revenues in Europe, and that reflects the strength of our current products, and recent launches as well.

今年再次，我相信我們是歐洲為數不多的收入增長的公司之一，這反映了我們當前產品的實力，以及最近推出的產品。

In terms of individual products, the highlights for 2013 include: Prolia and XGEVA, contributing $1.8 billion of sales, Sensipar, exceeding $1 billion for the first time, and after 15 years on the market Enbrel remaining the leading anti-TNF therapy, and of course Neulasta and NEUPOGEN, continuing to grow with the benefit of their established safety and efficacy track record.

在單個產品方面，2013 年的亮點包括：Prolia 和 XGEVA 貢獻了 18 億美元的銷售額，Sensipar 首次超過 10 億美元，Enbrel 上市 15 年後仍然是領先的抗 TNF 療法，以及當然，Neulasta 和 NEUPOGEN 憑藉其既定的安全性和有效性跟踪記錄繼續發展。

While delivering strong operating performance in 2013, we invested in the growth of our business, and that's reflected in our advanced pipeline.

在 2013 年實現強勁運營業績的同時，我們投資於業務增長，這反映在我們先進的產品線中。

We have 10 molecules that are in late stages of development, and set to deliver pivotal data by 2016.

我們有 10 個處於開發後期的分子，並準備在 2016 年之前提供關鍵數據。

We also have a portfolio of 6 biosimilar molecules that we expect to begin launching in 2017.

我們還有 6 種生物仿製藥分子的產品組合，預計將於 2017 年開始推出。

2014, in particular, will be a data rich year for us, and Sean will provide details on when we expect information to become available during the year.

尤其是 2014 年，對我們來說將是數據豐富的一年，Sean 將提供有關我們預計該年信息何時可用的詳細信息。

Just this past week and earlier this afternoon, we reported top line results from the third and fourth of our five pivotal studies for Evolocumab.

就在上周和今天下午早些時候，我們報告了 Evolocumab 五項關鍵研究中第三項和第四項的主要結果。

We're excited about the results that we're generating, and think they're forming the basis of a strong package for global registration.

我們對我們正在產生的結果感到興奮，並認為它們正在形成強大的全球註冊包的基礎。

In addition to making investments in our own R&D programs, we acquired Onyx and ivabradine rights in the US, and we look forward to advancing Kyprolis in the rapidly growing multiple myeloma market.

除了對我們自己的研發項目進行投資外，我們還在美國獲得了 Onyx 和伊伐布雷定的權利，我們期待在快速增長的多發性骨髓瘤市場推進 Kyprolis 的發展。

As you know, we believe Kyprolis has an important role to play as a backbone of therapy in multiple myeloma, and ivabradine looks to have an interesting prospect in heart failure.

如您所知，我們相信 Kyprolis 作為治療多發性骨髓瘤的支柱可以發揮重要作用，而伊伐布雷定看起來在心力衰竭方面具有有趣的前景。

On international expansion, we made significant progress in 2013 in Japan, China, and the key emerging markets.

在國際擴張方面，2013 年我們在日本、中國和主要新興市場取得了重大進展。

In Japan, our partnership with Astellas is off to a strong start, developing five innovative molecules in a business which Amgen can gain control of as early as 2020.

在日本，我們與 Astellas 的合作夥伴關係開局良好，在一項業務中開發了五種創新分子，Amgen 最早可以在 2020 年獲得該業務的控制權。

In China, we have filed (technical difficulty) and have in place a partnership with Beta Pharma to help launch the molecule.

在中國，我們已經提交了（技術難題）並與 Beta Pharma 建立了合作夥伴關係，以幫助推出該分子。

We expect to be able to launch Kryprolis in China shortly after Vectibix.

我們預計能夠在 Vectibix 之後不久在中國推出 Kryprolis。

In emerging markets through the reacquisition of our Neulasta and NEUPOGEN rights from Roche, we're now present in more than 75 countries, enabling us to exceed our international expansion goal two years earlier than originally planned.

在新興市場，通過從羅氏手中重新收購我們的 Neulasta 和 NEUPOGEN 權利，我們現在在超過 75 個國家/地區開展業務，使我們能夠比原計劃提前兩年超過我們的國際擴張目標。

Expanding our business into new regions is an important element of our growth strategy for the long-term.

將我們的業務擴展到新的地區是我們長期增長戰略的重要組成部分。

So let me conclude my comments with a few key messages.

因此，讓我用幾條關鍵信息來結束我的評論。

2014 is a year in which we expect to generate a lot of data.

2014 年是我們預計會產生大量數據的一年。

And while this data will inform our long-term growth prospects, we expect solid performance from our base business during the course of the year.

雖然這些數據將為我們的長期增長前景提供信息，但我們預計我們的基礎業務在這一年中會有穩健的表現。

With full ownership of Enbrel now in the US and Canada, we expect to grow its operating income contribution by some $800 million in 2014.

由於 Enbrel 現在在美國和加拿大擁有全部所有權，我們預計 2014 年其營業收入貢獻將增加約 8 億美元。

And as Michael Kelly will detail in a moment, we expect solid growth in revenues and adjusted earnings-per-share during 2014, which will enable us to continue growing our dividend consistent with our capital allocation strategy.

正如 Michael Kelly 稍後將詳述的那樣，我們預計 2014 年收入和調整後每股收益將實現穩健增長，這將使我們能夠根據我們的資本配置戰略繼續增加股息。

Finally, I'd like to thank all of my Amgen colleagues, many of whom may be listening into the call, for their contributions to delivering for our shareholders and patients last year.

最後，我要感謝我所有的 Amgen 同事，他們中的許多人可能正在聽電話，感謝他們去年為我們的股東和患者做出的貢獻。

I know I can count on my Amgen colleagues, as we work to create even more value in 2014.

我知道我可以依靠我的 Amgen 同事，因為我們將努力在 2014 年創造更多價值。

Now let me welcome Michael Kelly to the call, and ask him to walk you through our financial performance for the quarter.

現在讓我歡迎 Michael Kelly 來接電話，並請他向您介紹我們本季度的財務業績。

Michael?

邁克爾？

Thanks, Bob.

謝謝，鮑勃。

Turning to the fourth quarter on page 4 of the slide deck, you can see revenues grew by 13%, driven by strength across our product portfolio both in the US and internationally.

轉到幻燈片第 4 頁上的第四季度，您可以看到收入增長了 13%，這得益於我們在美國和國際上的產品組合的實力。

This also reflects incremental revenues following our acquisition of Onyx Pharmaceuticals, both from Kryprolis as well as from Nexavar and Sofargen.

這也反映了我們從 Kryprolis 以及 Nexavar 和 Sofargen 收購 Onyx Pharmaceuticals 後的增量收入。

Operating income grew by 24%, as operating costs grew well below revenues.

營業收入增長了 24%，因為營業成本的增長遠低於收入。

Within operating expenses, our cost of sales margin improved by 0.8 points to 16% driven by lower royalties.

在運營費用中，由於特許權使用費下降，我們的銷售利潤成本提高了 0.8 個百分點，達到 16%。

Research and development costs increased year-over-year, with roughly half of the increase due to the acquisition of Onyx and its Kryprolis clinical program.

研發成本同比增長，其中大約一半的增長是由於收購 Onyx 及其 Kryprolis 臨床項目。

The remainder was driven by our late stage clinical trials, particularly for Evolocumab.

其餘部分由我們的後期臨床試驗驅動，尤其是 Evolocumab。

SG&A expenses decreased by 3%, due to the end of the Enbrel profit share in the quarter.

由於本季度末 Enbrel 利潤分成，SG&A 費用下降了 3%。

Specifically, on October 31, our profit-sharing arrangement with Pfizer ended and was replaced with the royalty on Enbrel sales, which we will continue to report in the SG&A line going forward.

具體來說，10 月 31 日，我們與輝瑞公司的利潤分享安排結束，取而代之的是 Enbrel 銷售的特許權使用費，我們將繼續在 SG&A 行中報告。

The two month benefit of this change reduced expenses by about $130 million versus the year-ago quarter, and will contribute about $800 million next year.

這一變化帶來的兩個月收益與去年同期相比減少了約 1.3 億美元的支出，並將在明年貢獻約 8 億美元。

That benefit was partially offset by the addition of the Onyx SG&A expenses.

增加的 Onyx SG&A 費用部分抵消了該收益。

Net income increased 28%.

淨收入增長了 28%。

Similar to last quarter, the tax rate was lower compared to 2012, due to the federal R&D tax credit and the change in the geographic mix of expenses and revenues.

與上一季度相似，稅率低於 2012 年，原因是聯邦研發稅收抵免以及費用和收入的地域組合發生變化。

Finally, adjusted earnings-per-share were 30% higher, helped by a lower average share count compared to 2012.

最後，調整後的每股收益增加了 30%，這得益於與 2012 年相比較低的平均股數。

In summary, for the full-year on page 5, revenues grew 8% to $18.7 billion, and adjusted EPS grew 17% to $7.60 per share.

總之，第 5 頁的全年收入增長 8% 至 187 億美元，調整後每股收益增長 17% 至 7.60 美元。

We exit 2013 with good momentum as we move into 2014.

進入 2014 年，我們以良好勢頭結束 2013 年。

Turning next to cash flow and the balance sheet on page 6, we generated $5.6 billion in free cash flow in 2013, and increased our quarterly dividend per share by 31%, with payments totaling $1.4 billion.

接著轉到第 6 頁的現金流和資產負債表，我們在 2013 年產生了 56 億美元的自由現金流，並將每股季度股息增加了 31%，支付總額為 14 億美元。

As you are aware, we announced another 30% increase to the dividend starting with our first-quarter 2014 payment.

如您所知，我們宣布從 2014 年第一季度付款開始將股息再增加 30%。

We remain committed to our capital allocation strategy, and continuing to increase the dividend over time.

我們仍然致力於我們的資本配置策略，並隨著時間的推移繼續增加股息。

At the end of the year, we held $22.8 billion in cash, short-term, and restricted investments, and $32.1 billion in debt.

截至年底，我們持有 228 億美元的現金、短期和限制性投資，以及 321 億美元的債務。

The roughly $5 billion increase in debt from the end of the third quarter reflects borrowings to complete our Onyx acquisition funding.

與第三季度末相比，債務增加了大約 50 億美元，反映了為完成我們的 Onyx 收購資金而藉款。

Finally in 2013, share repurchases amounted to $800 million, at an average price of $85 per share, all in the first quarter.

最後在 2013 年，第一季度股票回購金額達到 8 億美元，平均價格為每股 85 美元。

You will notice that our average share count increased sequentially in both the third and fourth quarters, as we did not repurchase shares, and saw some dilution from stock-based compensation.

你會注意到我們的平均股票數量在第三和第四季度連續增加，因為我們沒有回購股票，並且看到基於股票的薪酬帶來了一些稀釋。

Let me remind you that we don't expect any significant repurchase activity in 2014 and 2015, and thus, expect to see similar effects on share count going forward.

讓我提醒您，我們預計 2014 年和 2015 年不會出現任何重大的回購活動，因此預計未來會看到類似的股票數量影響。

Now let me turn to guidance for 2014 on page 7. We expect total revenues in the range of $19.2 billion to $19.6 billion, and adjusted earnings-per-share in the range of $7.90 to $8.20.

現在讓我轉到第 7 頁上的 2014 年指引。我們預計總收入在 192 億美元至 196 億美元之間，調整後的每股收益在 7.90 美元至 8.20 美元之間。

This includes the $800 million operating income benefit from our full ownership of Enbrel in the US and Canada.

這包括我們在美國和加拿大完全擁有 Enbrel 所帶來的 8 億美元營業收入收益。

Our adjusted tax rate is expected to range between 15% and 16%, which assumes that the R&D tax credit legislation will be passed in 2014, and retroactively apply to all of 2014.

我們調整後的稅率預計在 15% 和 16% 之間，假設研發稅收抵免立法將於 2014 年通過，並追溯適用於 2014 年全年。

And lastly, capital expenditures are expected to be approximately $800 million, a slight increase from the last few years, reflecting investments in Onyx Pharmaceuticals and our global manufacturing operations.

最後，資本支出預計約為 8 億美元，比過去幾年略有增加，反映了對 Onyx Pharmaceuticals 和我們全球製造業務的投資。

Let me now turn to Tony.

現在讓我談談托尼。

Thank you.

謝謝你。

Thanks, Michael, and good afternoon everyone.

謝謝，邁克爾，大家下午好。

You'll find the summary of our global sales performance on slide number 8.

您會在第 8 張幻燈片上找到我們全球銷售業績的摘要。

We delivered strong fourth-quarter performance with product sales, including Kyprolis growing at about 11%.

我們在第四季度實現了強勁的產品銷售業績，其中包括增長約 11% 的 Kyprolis。

In the US, our business grew 11% year-over-year and in the fourth quarter.

在美國，我們的業務在第四季度同比增長 11%。

US wholesale inventory levels ended at the high end of our normal range.

美國批發庫存水平處於我們正常範圍的高端。

Outside the US, our business grew 9% in the fourth quarter, or 10% excluding the impact of foreign exchange.

在美國以外，我們的業務在第四季度增長了 9%，如果不考慮外彙的影響，則增長了 10%。

I'd like to review our fourth-quarter product performance, beginning with Neulasta and NEUPOGEN.

我想回顧一下我們第四季度的產品表現，首先是 Neulasta 和 NEUPOGEN。

Year-over-year global sales for Neulasta increased by 10% in the fourth quarter.

第四季度 Neulasta 的全球銷售額同比增長了 10%。

This was mainly driven by price, with unit demand remaining stable.

這主要是由價格驅動的，單位需求保持穩定。

NEUPOGEN sales were flat year-over-year, while quarter-over-quarter sales declined 34%, due to the $155 million order from the US Government in the third quarter.

NEUPOGEN 銷售額同比持平，而環比銷售額下降 34%，原因是第三季度美國政府下達了 1.55 億美元的訂單。

We've seen minimal impact from recently launched competition, as Neulasta and NEUPOGEN shares remained stable in both the US and Europe during in the fourth quarter.

我們看到最近發起的競爭的影響很小，因為 Neulasta 和 NEUPOGEN 的股票在第四季度在美國和歐洲都保持穩定。

We continue, however, to take all competition seriously.

然而，我們繼續認真對待所有競爭。

Now to Enbrel, fourth-quarter sales grew 3% year-over-year, largely due to price.

現在對 Enbrel 來說，第四季度銷售額同比增長 3%，這主要是由於價格。

Our investment in direct-to-consumer advertising with Phil Mickelson continues to drive brand awareness, which is important, as physicians continue to honor over 90% of Enbrel patient requests.

我們與 Phil Mickelson 在直接面向消費者的廣告方面的投資繼續推動品牌知名度，這很重要，因為醫生繼續滿足 90% 以上的 Enbrel 患者要求。

We remain the value share leader in both rheumatology and the dermatology segments, and we are confident in Enbrel's potential growth.

我們仍然是風濕病學和皮膚病學領域的價值份額領導者，我們對 Enbrel 的潛在增長充滿信心。

Moving on to Aranesp.

繼續 Aranesp。

Aranesp sales were down 4% year-on-year.

Aranesp 銷售額同比下降 4%。

We continue to see price pressure in Europe, and segment slowdown in the US.

我們繼續看到歐洲的價格壓力和美國的細分市場放緩。

EPOGEN sales increased 10% year-over-year.

EPOGEN 銷售額同比增長 10%。

This was mainly driven by an increase in unit demand, due to the withdrawal of Omontys in early 2013.

這主要是由於 2013 年初 Omontys 的退出導致單位需求增加。

Hemoglobin levels have remained relatively stable throughout 2013, based on our most recent data.

根據我們的最新數據，2013 年血紅蛋白水平保持相對穩定。

We will continue to monitor end user dose utilization, as the new 2014 bundle payments go into effect.

隨著新的 2014 年捆綁支付生效，我們將繼續監測最終用戶的劑量使用情況。

Now I'll turn to Sensipar.

現在我將轉向 Sensipar。

As Bob mentioned, global Sensipar sales exceeded $1 billion in 2013 for the first time ever.

正如 Bob 提到的，Sensipar 的全球銷售額在 2013 年首次超過 10 億美元。

For the fourth quarter, sales increased 20% year-over-year, due to segment growth, and increased penetration in Europe.

第四季度，銷售額同比增長 20%，這得益於細分市場的增長以及在歐洲的滲透率提高。

Nplate and Vectibix sales in aggregate were higher by 16% year-over-year, mainly due to increases in unit demand.

Nplate 和 Vectibix 的總銷售額同比增長 16%，這主要是由於單位需求的增加。

Our European Vectibix label for the treatment of meta static colorectal cancer, now includes the new end RAS and first line data.

我們用於治療轉移性結直腸癌的歐洲 Vectibix 標籤現在包括新的末端 RAS 和一線數據。

We're excited about the growth potential for Vectibix in Europe and its benefits for patients.

我們對 Vectibix 在歐洲的增長潛力及其對患者的益處感到興奮。

For Nplate, we've continued to see segment growth in both the US and European markets.

對於 Nplate，我們繼續看到美國和歐洲市場的細分市場增長。

Moving now to Denosumab.

現在轉向狄諾塞麥。

As Bob noted, the D-mab franchise contributed sales of $1.8 billion in 2013.

正如 Bob 指出的那樣，D-mab 特許經營權在 2013 年貢獻了 18 億美元的銷售額。

In the fourth quarter, Prolia sales grew 53% year-over-year, driven by increased segment share in both the US and Europe.

在第四季度，受美國和歐洲市場份額增加的推動，Prolia 銷售額同比增長 53%。

We've now launched in all major European countries.

我們現在已經在所有主要的歐洲國家推出。

In the US, our direct consumer campaign has been very successful.

在美國，我們的直接消費者活動非常成功。

Prolia is now the most requested brand by new postmenopausal osteoporosis patients.

Prolia 現在是絕經後骨質疏鬆症新患者最需要的品牌。

We are launching a new campaign with Blythe Danner in the next few weeks to continue raising patient awareness.

我們將在接下來的幾週內與 Blythe Danner 一起發起一項新活動，以繼續提高患者的意識。

I'm pleased to note that XGEVA also reached the $1 billion milestone in 2013.

我很高興地註意到 XGEVA 在 2013 年也達到了 10 億美元的里程碑。

This is our seventh product to exceed $1 billion in annual sales.

這是我們第七個年銷售額超過 10 億美元的產品。

For the fourth quarter, XGEVA global sales grew 33% year-over-year.

第四季度，XGEVA 全球銷售額同比增長 33%。

Outside the US, XGEVA grew 124% year-over-year.

在美國以外，XGEVA 同比增長 124%。

Our commercial focus remains in reminding physicians and patients of the superior clinical profile of XGEVA.

我們的商業重點仍然是提醒醫生和患者 XGEVA 卓越的臨床特徵。

This is an important differentiator in the face of generic zolodronic acid competition.

這是面對仿製藥唑洛膦酸競爭的一個重要區別因素。

We grew market share in the US by 3 percentage points, and saw successful launches and growth in Europe.

我們在美國的市場份額增長了 3 個百分點，並在歐洲成功推出並實現增長。

XGEVA is now available in all major markets.

XGEVA 現在在所有主要市場都有售。

Let me now turn to our newest product, Kyprolis.

現在讓我談談我們的最新產品 Kyprolis。

Kyprolis achieved quarter-over-quarter growth in the fourth quarter as the Onyx acquisition closed.

隨著 Onyx 收購的結束，Kyprolis 在第四季度實現了環比增長。

The underlying demand growth was consistent with second and third quarters.

潛在需求增長與第二和第三季度一致。

Based on our data, Kyprolis continues to be the therapy of choice in the relapsed refractory multiple myeloma settings in the US.

根據我們的數據，Kyprolis 仍然是美國復發難治性多發性骨髓瘤患者的首選療法。

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

我們預計 Kyprolis 的下一個主要轉折點將是在我們的標籤中包含二線數據。

In summary, we'll built on the progress we made in 2013, as we execute on growth opportunities for 2014 and beyond.

總而言之，我們將在 2013 年取得的進展的基礎上再接再厲，抓住 2014 年及以後的增長機會。

Let me now pass it to Sean.

現在讓我把它傳遞給肖恩。

Good afternoon.

下午好。

We have an exciting year ahead with data flow from our pipeline that's already begun with our new press releases recently on top line results from our third and fourth phase III studies of Evolocumab, which were very encouraging for patients with Dyslipidemia and high risk for cardiovascular [events].

我們迎來了激動人心的一年，我們管道的數據流已經開始，我們最近發布了關於 Evolocumab 第三和第四階段 III 期研究的重要結果，這對患有血脂異常和心血管疾病高風險的患者來說非常令人鼓舞 [事件]。

We anticipate the results of our last pivotal phase III efficacy study in patients with heterozygous familial hypercholesterolemia in the near future.

我們預計我們在不久的將來對雜合子家族性高膽固醇血症患者進行的最後一項關鍵 III 期療效研究的結果。

We believe these studies will support a global filing plan in 2014, based on the reduction of LDL cholesterol.

我們相信這些研究將支持 2014 年基於低密度脂蛋白膽固醇降低的全球申報計劃。

Of course, the precise timing will depend on our ongoing discussions with various regulatory agencies.

當然，確切的時間將取決於我們與各個監管機構正在進行的討論。

In the US, for example, timing for Evolocumab is dependent on having achieved appropriate progress in our outgoing outcome study.

例如，在美國，Evolocumab 的上市時間取決於我們即將進行的結局研究是否取得了適當的進展。

Turning to our oncology programs, we were encouraged by the feedback on Kyprolis from clinicians at the ASH meeting last month, and are looking forward to new Kyprolis data in the first half of this year.

談到我們的腫瘤項目，我們對上個月 ASH 會議上臨床醫生對 Kyprolis 的反饋感到鼓舞，並期待今年上半年的新 Kyprolis 數據。

Including a review by an independent data monitoring committee of an interim analysis of the ASPIRE study in relapsed multiple myeloma patients.

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

I would note that ASPIRE compares a regimen containing Kyprolis on top of Rev-Dex to Rev-Dex alone, and may be an instrumental study in expanding Kyprolis'slabel to earlier lines of therapy.

我要指出的是，ASPIRE 比較了在 Rev-Dex 之上包含 Kyprolis 的方案與單獨使用 Rev-Dex 的方案，並且可能是將 Kyprolis 的標籤擴展到早期治療線的一項工具性研究。

We are also expecting the final analysis of the FOCUS study in relapsed refractory multiple myeloma during the first half of the year.

我們也期待在今年上半年對複發難治性多發性骨髓瘤的 FOCUS 研究進行最終分析。

Our two amino oncology programs continue to advance as well.

我們的兩個氨基腫瘤學項目也在繼續推進。

In 2013, we reported that our phase III T-VEC study in metastatic melanoma met its durable response rate primary ends line with favorable interim trends in overall survival.

2013 年，我們報告說，我們在轉移性黑色素瘤中進行的 III 期 T-VEC 研究達到了持久緩解率主要終點線，並在總生存期方面取得了良好的中期趨勢。

We continue to expect the final overall survival data in the first half of this year.

我們繼續期待今年上半年的最終總生存數據。

We believe there is also an opportunity for T-VEC to prime the immune system with the so-called checkpoint inhibitors, and we are currently investigating T-VEC in combination with ipilimumab in a phase I-B study.

我們相信 T-VEC 也有機會用所謂的檢查點抑製劑啟動免疫系統，我們目前正在 I-B 期研究中研究 T-VEC 與 ipilimumab 的結合。

And are planning to study T-VEC soon with other immune-based therapies such as PD one antagonism.

併計劃很快研究 T-VEC 與其他基於免疫的療法，如 PD one 拮抗作用。

We also expect blinatumomab confirmatory phase II results in relapsed refractory adult acute lymphoblastic leukemia in the first half of 2014, and we've also initiated a phase III study in this indication.

我們還預計 2014 年上半年 blinatumomab 的 II 期驗證結果將用於治療復發性難治性成人急性淋巴細胞白血病，我們還啟動了該適應症的 III 期研究。

For trebananib, our peptibody direct to the angiopoietin access, we continue to estimate the final overall survival analysis from the ongoing pivotal study in recurrent ovarian cancer to occur in the second half of 2014.

對於 trebananib，我們的肽體直接作用於血管生成素通路，我們繼續估計 2014 年下半年正在進行的複發性卵巢癌關鍵研究的最終總體生存分析。

Recall that this study met its PFS primary endpoint in 2013.

回想一下，這項研究在 2013 年達到了其 PFS 主要終點。

Velcalcetide or AMG 416, is our novel IV calcineumatic being investigated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.

Velcalcetide 或 AMG 416 是我們正在研究的新型 IV 鈣調劑，用於治療接受血液透析的慢性腎病患者的繼發性甲狀旁腺功能亢進症。

Phase III data are expected in the second half of this year.

III 期數據預計在今年下半年公佈。

Our psoriasis program for brodalumab consists of three phase III studies, one placebo-controlled and two head-to-head studies comparing to ustekinumab or Stelara.

我們的 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。

I'm pleased to report we expect to see the data from the first of these studies in the first half, with the other two reading out during the course of the year.

我很高興地報告，我們希望在上半年看到這些研究中第一項的數據，另外兩項研究將在年內公佈。

On January 1st, our romosuzumab phase II data in postmenopausal osteoporosis was published in the New England Journal, and described in the accompanying editorial as quote, a potential breakthrough in osteoporosis therapeutics.

1 月 1 日，我們在絕經後骨質疏鬆症中的 II 期數據發表在《新英格蘭雜誌》上，並在隨附的社論中引用了引述，這是骨質疏鬆症治療的潛在突破。

We have reassessed the sample size for our placebo-controlled two-year fractures trial on the basis of a slightly lower than anticipated event rate, and accordingly increased the sample size in [debt].

我們根據略低於預期的事件發生率重新評估了安慰劑對照的兩年期骨折試驗的樣本量，並相應地增加了 [債務] 的樣本量。

The study actually completed enrollment in Q4.

該研究實際上在第 4 季度完成了招募。

Recall that this is a two-year fracture study, and consequently, we expect the study will read out in the first half of 2016.

回想一下，這是一項為期兩年的骨折研究，因此，我們預計該研究將在 2016 年上半年宣讀。

We have also initiated a phase III head-to-head study of romosuzumab against teriparatide, exploring the bone mineral density, advanced imaging, and biomarker end points in postmenopausal women previously treated with diphosphonates.

我們還啟動了 romosuzumab 與特立帕肽的 III 期頭對頭研究，探索先前接受二膦酸鹽治療的絕經後婦女的骨密度、高級成像和生物標誌物終點。

We remain very excited about the potential for romosuzumab.

我們仍然對 romosuzumab 的潛力感到非常興奮。

As you may recall, we have developed the only monoclonal antibody antagonist of the CGRP receptor that's in the clinic, AMG 334, which has demonstrated a potent ability to pharmacodynamically block this access in phase I. Accordingly, we've initiated a phase II dose ranging study in patients with episodic migraines, and are planning to soon initiate a study in chronic migraines.

您可能還記得，我們開發了臨床上唯一的 CGRP 受體單克隆抗體拮抗劑 AMG 334，它已證明在 I 期藥效學上具有阻斷這種通路的強大能力。因此，我們已經啟動了 II 期劑量對發作性偏頭痛患者進行廣泛研究，併計劃很快啟動一項針對慢性偏頭痛的研究。

Our biosimilars unit continues to make good progress, and I am pleased to report that enrollment has commenced in our biosimilar Avastin and pivotal study.

我們的生物仿製藥部門繼續取得良好進展，我很高興地報告，我們的生物仿製藥 Avastin 和關鍵研究的註冊已經開始。

To remind you, we now have three pivotal biosimilar studies underway: Avastin, Herceptin, and Humira.

提醒您，我們現在正在進行三項關鍵的生物仿製藥研究：Avastin、Herceptin 和 Humira。

Finally, I'd like to take a moment personally to thank my colleagues both in R&D and many other parts of the Company for helping to make possible a very promising 2014, with lots of momentum building toward delivering a wave of innovative therapeutics for patients in need.

最後，我想親自感謝我在研發部門和公司許多其他部門的同事，感謝他們幫助我們創造了一個充滿希望的 2014 年，為在需要。

Bob?

鮑勃？

All right.

好的。

Thank you, Sean.

謝謝你，肖恩。

Let's open it up now for questions, and Marvin why don't you remind our callers of the procedures and we'll start with the first question.

現在讓我們開始提問，馬文，你為什麼不提醒我們的來電者程序，我們將從第一個問題開始。

(Operator Instructions)

（操作員說明）

Robyn Karnauskas, Deutsche Bank.

Robyn Karnauskas，德意志銀行。

Starting off with the pipeline AMG 416, maybe you could talk a little bit about how you see its place in the market versus where Sensipar is now, and what kind of data would make doctors think it's superior?

從管道 AMG 416 開始，也許你可以談談你如何看待它在市場上的地位與 Sensipar 現在的位置，以及什麼樣的數據會讓醫生認為它更優越？

And then I guess another part of that question is it's IV, so it might be in the bundle.

然後我猜這個問題的另一部分是它是 IV，所以它可能在捆綁包中。

How do you think about the market opportunity given that?

鑑於此，您如何看待市場機會？

Thank you, Robyn.

謝謝你，羅賓。

So from a market perspective, let me just talk quickly.

因此，從市場的角度來看，讓我快速談談。

Obviously, Sensipar has been very successful in terms of both growing the segment and increasing penetration in their [one of the moment].

顯然，Sensipar 在擴大細分市場和提高 [one of the moment] 的滲透率方面都非常成功。

One of the issues we have of course is constant patient compliance, and we find a large number of patients aren't staying on their drug for the entire 12 month period.

我們遇到的問題之一當然是患者的持續依從性，我們發現大量患者在整個 12 個月期間都沒有堅持服用藥物。

The IV form, of course, which will be covered administered during dialysis would make life much easier, and therefore, we think both in terms of outcomes and in terms of maintaining patient on the drug it will be a unique opportunity to add to the bundle.

當然，IV 形式將在透析期間進行管理，這將使生活更加輕鬆，因此，我們認為無論是在結果方面還是在維持患者對藥物的方面，這都將是添加到捆綁包中的獨特機會.

Mark Schoenebaum, ISI Group.

ISI 集團的 Mark Schoenebaum。

I was just wondering, Sean, I think you said you're going to file on 145 in 2014?

我只是想知道，肖恩，我想你說過你將在 2014 年提交 145 號文件？

I was just confirming that the first time you said that or maybe I just haven't done my homework.

我只是在確認你第一次這麼說，或者我只是沒有做功課。

And second of all, there's been --we've heard from other folks that the FDA has asked PCSK9 sponsors to have roughly 25% of their events accrued in the outcomes trials at the time of filing.

其次，我們從其他人那裡聽說，FDA 已要求 PCSK9 贊助商在提交申請時將大約 25% 的事件累積在結果試驗中。

Can you give us any color if you've received that kind of feedback, or if you would encourage me not to believe those people that are saying those things?

如果你收到了那種反饋，你能給我們一些顏色嗎，或者你是否會鼓勵我不要相信那些說那些話的人？

Thank you very much.

非常感謝。

Okay.

好的。

Well first of all, yes, I think this is the first time that we've been clear that we would be receiving all the pivotal data sets in a timeframe where we would be pursuing global filing plans in 2014, and that is our intent.

首先，是的，我認為這是我們第一次明確表示我們將在 2014 年推行全球申報計劃的時間範圍內收到所有關鍵數據集，這就是我們的意圖。

As I mentioned, with each jurisdiction, we'll have discussions with regulators about the precise timing and requirements for filing.

正如我提到的，對於每個司法管轄區，我們將與監管機構討論提交的確切時間和要求。

It's clear that the FDA are interested in understanding that these outcomes studies are progressing and that there's an ability to have some sense of when the final results would become available from an outcomes study.

很明顯，FDA 有興趣了解這些結果研究正在取得進展，並且有能力了解何時可以從結果研究中獲得最終結果。

But really, these are ongoing discussions.

但實際上，這些是正在進行的討論。

We have initial consultations with regulators when we're just in a concept phase.

當我們還處於概念階段時，我們會與監管機構進行初步磋商。

And later when we actually have data, we have much more in depth interactions and discussions.

稍後當我們真正擁有數據時，我們會進行更深入的互動和討論。

So I don't generally discuss the details of these fluid interactions that go on over the course of time with regulators.

因此，我一般不會討論隨著時間的推移與監管機構發生的這些流動相互作用的細節。

But it is clear that the agency is wanting to have an understanding of the trajectory of the outcomes trials before they would proceed with approving this class of product, based on just LDL lowering alone if they did make that choice.

但很明顯，該機構希望在繼續批准此類產品之前了解結果試驗的軌跡，如果他們確實做出了這種選擇，則僅基於 LDL 降低。

Eric Schmidt, Cowen and Company.

埃里克施密特，考恩公司。

It's on the revenue guidance for 2014.

它在 2014 年的收入指導中。

It looks like you're not only forecasting a deceleration in growth, but also a slower rate for sales than you are exiting Q4 in, and I assume some of the inventory effects that Tony mentioned have to do with that.

看起來你不僅預測增長減速，而且銷售速度也比你退出第四季度時慢，我認為托尼提到的一些庫存效應與此有關。

But maybe if you could just broadly outline how you're thinking about the current portfolio and its growth prospects in 2014, which if any franchises might be declining.

但也許您可以大致概述一下您對當前投資組合的看法及其在 2014 年的增長前景，如果有任何特許經營權可能會下降。

Sure.

當然。

Go ahead, Tony, why don't address Eric's specific comments, and then I'll add if I could.

繼續吧，托尼，為什麼不解決埃里克的具體意見，如果可以的話，我會補充。

So fundamentally, the inventory we sold half of in the US when I say ending at the slight up end of the range is about a day, so it's about $50 million in terms of wholesale of inventory.

所以從根本上說，當我說結束於該範圍的小幅上升時，我們在美國售出一半的庫存大約是一天，所以就庫存批發而言，大約是 5000 萬美元。

We think there might have been another $50 million at the end user, but not a large amount of money.

我們認為最終用戶可能還有 5000 萬美元，但不是很多錢。

The product mix as we go forward into 2014 starts to change slightly, of course, as we get to the first and the full competition on the filgrastim portfolio.

隨著我們進入 2014 年，產品組合開始略有變化，當然，隨著我們進入非格司亭產品組合的第一個全面競爭。

We have potential competition from Mircera against Epogen, and our growth brands are now coming off a much higher base.

我們面臨來自 Mircera 與 Epogen 的潛在競爭，我們的成長型品牌現在的基礎要高得多。

So that's why you've possibly seen some slowdown but strong positive growth.

所以這就是為什麼你可能會看到一些放緩但強勁的正增長。

And, Eric, the other thing I'd add is while we provided revenue and earnings-per-share growth, we obviously also addressed the strong operating income growth that we're expecting driven by the improved contribution from Enbrel.

而且，埃里克，我要補充的另一件事是，雖然我們提供了收入和每股收益增長，但我們顯然也解決了我們預期由 Enbrel 的貢獻增加所推動的強勁營業收入增長。

So, you ought to expect that we're focused on driving strong operating income growth this year, and with that, strong cash flow growth.

因此，您應該期望我們今年專注於推動強勁的營業收入增長，以及隨之而來的強勁現金流增長。

Terence Flynn, Goldman Sachs.

特倫斯弗林，高盛。

Was just wondering with respect to the PCSK9, if you can give us any latest thoughts on your delivery device, and if a bridging trial is going to required for the new device?

只是想知道關於 PCSK9，您是否可以向我們提供有關您的傳輸設備的任何最新想法，以及新設備是否需要進行橋接試驗？

And then I realize you're not going to comment directly on pricing for this class, but maybe can you walk us through any of the potential factors that are going to guide your decision on pricing?

然後我意識到你不會直接評論這個課程的定價，但也許你能告訴我們任何將指導你定價決定的潛在因素嗎？

Thanks a lot.

非常感謝。

Okay, this is Sean.

好的，這是肖恩。

I think we remain clear in our position that we don't want to get into the details around these devices, and the regulatory strategy behind them.

我認為我們的立場仍然很明確，我們不想深入了解這些設備的細節，以及它們背後的監管策略。

We're confident in having a every two week and monthly presentations for the product, and I'd prefer not to get into more detail than that.

我們有信心每兩周和每月對該產品進行一次演示，我不想透露更多細節。

Tony, you may want to comment on the second half of the question.

托尼，你可能想對問題的後半部分發表評論。

So just in terms of price, everything is really around the fact that there continues to be a huge unmet medical need with patients with cardiovascular risk, even when they're on statins.

因此，就價格而言，一切都圍繞著這樣一個事實，即患有心血管疾病的患者仍然存在巨大的未得到滿足的醫療需求，即使他們正在服用他汀類藥物。

We expect or we see more than 30% of patients don't reach goal, and therefore, remain at high risk of either heart attack or death in fact.

我們預計或我們看到超過 30% 的患者沒有達到目標，因此實際上仍然處於心髒病發作或死亡的高風險中。

So we will price this drug clearly around that unmet need in the marketplace, understanding that this is a biologic, yes.

因此，我們將圍繞市場上未滿足的需求明確定價這種藥物，了解這是一種生物製劑，是的。

Yaron Werber, Citigroup.

Yaron Werber，花旗集團。

This is also a little bit of a financial question, but if you looked historically, I guess I just follow on to Eric's question.

這也是一個財務問題，但如果你從歷史上看，我想我只是繼續 Eric 的問題。

I'm just trying to get a sense here of how conservative is your guidance or rather how much competitive headwinds are you expecting in the revenue line?

我只是想在這裡了解您的指導有多保守，或者更確切地說，您在收入方面期望有多少競爭阻力？

And what are you -- help us understand maybe if you can a little bit of the OpEx, too.

你是什麼——幫助我們了解你是否也能了解一點 OpEx。

Because I think the guidance is below consensus and [it's still]surprising.

因為我認為該指南低於共識並且[它仍然]令人驚訝。

Well, Yaron, as I said, we expect to drive strong operating income growth this year, and that includes our expectations.

好吧，Yaron，正如我所說，我們預計今年將推動強勁的營業收入增長，這包括我們的預期。

We've talked about from some time that we will drive operating income contribution by an incremental $800 million for Enbrel, and we ended the quarter with momentum as you saw in our results.

一段時間以來，我們一直在討論我們將為 Enbrel 增加 8 億美元的營業收入貢獻，並且正如您在我們的結果中看到的那樣，我們在本季度結束時勢頭強勁。

Tony outlined a couple of the areas where there's some uncertainty heading into the year, but fundamentally across the products and geographies, we feel very good about the performance that we ended the year with, and therefore, the momentum that we're carrying over in the first quarter.

Tony 概述了進入今年存在一些不確定性的幾個領域，但從根本上說，在整個產品和地區，我們對今年結束時的表現感到非常滿意，因此，我們正在延續的勢頭第一季度。

So we expect strong results, as I said, during the course of 2014 as we continue to invest in the long-term drivers of growth here, which are the pipeline, and international expansion, and biosimilars and the things that I talked about my remarks.

因此，正如我所說，我們預計在 2014 年期間會取得強勁的成果，因為我們將繼續投資於這裡的長期增長驅動因素，即管道、國際擴張、生物仿製藥以及我談到的事情.

But I think we touched on the elements of Eric's comments.

但我想我們已經觸及了 Eric 評論的要點。

Tony, do you want to add anything to the --?

托尼，你想補充什麼嗎？

(multiple speakers)

（多個揚聲器）

No, we continue to drive the growth brand.

不，我們繼續推動增長品牌。

We're building market share.

我們正在建立市場份額。

It's a bit early in the year to be saying we know exactly where we will land, and we are competing at every stage, and we look forward to actually building this business and growing it.

現在說我們確切地知道我們將在哪裡著陸還為時過早，我們在每個階段都在競爭，我們期待真正建立並發展這項業務。

Yaron, I think the tax rate and shares, in terms of the bottom line, I think the tax rate and shares were probably above where we were as well if you look at those consensus numbers.

Yaron，我認為稅率和股票，就底線而言，如果你看看那些共識數字，我認為稅率和股票可能也高於我們的水平。

So the tax rate clearly in 2013 was low for reasons that won't be repeated in 2014, and I think we were pretty clear during the course of the year with each of our quarters as to what was going on there.

因此，由於 2014 年不會重複的原因，2013 年的稅率顯然很低，而且我認為我們在這一年的每個季度都非常清楚那裡發生了什麼。

And on our share count, again, I think Michael tried to provide some clear guidance for you on that front as well as we head into 2014.

關於我們的分享數量，我認為 Michael 試圖在我們進入 2014 年時在這方面為您提供一些明確的指導。

Yaron, I would just note that our guidance that we have given is actually bracketed by the consensus expectations, because the consensus is $19.5 billion for revenues, and for earnings per share it's $8.16.

Yaron，我只想指出，我們給出的指導實際上包含在共識預期中，因為共識是收入為 195 億美元，每股收益為 8.16 美元。

Michael Yee, RBC Capital Markets.

Michael Yee，RBC 資本市場。

A question actually on AMG 334, I think that's the first time that you mentioned that, at least speaking about it on the call.

實際上是關於 AMG 334 的問題，我認為這是你第一次提到這個問題，至少在電話會議上談到了它。

I'm sure you're aware that Lilly made an announcement I think just a couple weeks ago on theirs.

我相信你知道 Lilly 就在幾週前發布了他們的公告。

Maybe you could speak to whether or not we'd actually get data on that drug this year, and how that would be different than Lilly's drug?

也許你可以談談我們今年是否真的會獲得關於該藥物的數據，以及這與禮來的藥物有何不同？

So, it is hard to be sure when we'll see the data, but it is possible that data from the first study, which is in episodic migraine, might be available by the end of the calendar year.

因此，很難確定我們何時會看到數據，但第一項針對發作性偏頭痛的研究的數據可能會在日曆年年底提供。

The difference in the drugs is fundamental.

藥物的區別是根本的。

The other agents are agents that [amoclanab] are considered directed at epitopes on CGRP itself, Our strategy is to block the receptor, which is then independent of CGRP concentration and timing of release.

其他藥物是 [amoclanab] 被認為是針對 CGRP 本身表位的藥物，我們的策略是阻斷受體，然後它與 CGRP 濃度和釋放時間無關。

So then the synapse, that can be very important.

那麼突觸可能非常重要。

So, our first principles thinking about this biology as well as the pre clinical data that we've generated have suggested that it's a much more effective approach potentially to have a receptor antagonist than a ligand sequestering antibodies.

因此，我們考慮這種生物學的首要原則以及我們生成的臨床前數據表明，與配體螯合抗體相比，受體拮抗劑可能是一種更有效的方法。

So there is a differentiated feature there.

所以那裡有一個差異化的特徵。

Ian Somaiya, Nomura.

伊恩·索邁亞，野村證券。

Quick question on Kyprolis.

關於 Kyprolis 的快速問題。

I just was hoping to get your thoughts on the competitive landscape as we are expecting phase III data from Lilly's one competitor, Bristol and AbbVie, their drug elotuzumab.

我只是希望了解您對競爭格局的看法，因為我們期待來自禮來公司的一個競爭對手 Bristol 和 AbbVie 的 III 期數據，他們的藥物 elotuzumab。

So I just wanted to get your thoughts on how we should think about your data sets and also the emerging data sets for that molecule.

所以我只是想了解您對我們應該如何考慮您的數據集以及該分子的新興數據集的想法。

And then just into the future a little bit, HDAC 6 inhibitors, and how if there are any plans to run combination studies with Kyprolis.

然後就在不久的將來，HDAC 6 抑製劑，以及是否有任何計劃與 Kyprolis 進行聯合研究。

So this is Tony, let me start some of that discussion, and perhaps Sean can add.

我是托尼，讓我開始一些討論，也許肖恩可以補充。

When we looked at the multiple myeloma market, it's clear that in spite of the tremendous advances over the last decade or so, there continues to be a huge unmet medical need.

當我們審視多發性骨髓瘤市場時，很明顯，儘管在過去十年左右取得了巨大進步，但仍然存在巨大的未滿足的醫療需求。

Average life expectancy has moved now to only six years, and we clearly believe that physicians will be looking more and more for drugs that deliver efficacy or combinations of drugs that deliver efficacy and extend life.

現在的平均預期壽命已變為僅六年，我們清楚地相信，醫生將越來越多地尋找具有療效的藥物或具有療效和延長壽命的藥物組合。

As a Company, we continue to believe that the proteasome inhibitors will continue to be a backbone of multiple myeloma therapy.

作為一家公司，我們仍然相信蛋白酶體抑製劑將繼續成為多發性骨髓瘤治療的支柱。

And based on our own scientific evaluation, our clinical evaluation, and talking to experienced KOLs around the world, we continue to believe that Kyprolis has the potential to be the best in class in this particular category.

根據我們自己的科學評估、臨床評估以及與世界各地經驗豐富的 KOL 的交談，我們仍然相信 Kyprolis 有潛力成為這一特定類別中的佼佼者。

So we look forward to advancing our phase III data, expanding our label, and giving physicians an opportunity to use this drug in earlier lines with patients as we go forward.

因此，我們期待著推進我們的 III 期數據，擴大我們的標籤，並讓醫生有機會在我們前進的過程中在早期對患者使用這種藥物。

It's little to add, I agree and I think the issue of the combinations with things like the antibody therapies through HBAC inhibitors will play out over time.

沒什麼可補充的，我同意，我認為通過 HBAC 抑製劑與抗體療法等組合的問題將隨著時間的推移而發揮作用。

But it's hard to imagine a situation in which the proteasome inhibition backbone is displaced in any near-term sense.

但很難想像在任何近期意義上蛋白酶體抑制骨幹被取代的情況。

Geoffrey Porges, Bernstein.

伯恩斯坦的杰弗里波赫斯。

Sean, you've now seen four of the five pivotal trials, or at least the near term pivotal trials for 145.

肖恩，你現在已經看到了五個關鍵試驗中的四個，或者至少看到了 145 的近期關鍵試驗。

And you've disclosed more or less that the LDL reduction is consistent with phase II.

而且您或多或少地透露了 LDL 的降低與 II 期一致。

Could you give us a sense of what you're seeing qualitatively and quantitatively in terms of CV events?

您能否讓我們了解一下您在 CV 事件方面看到的定性和定量情況？

I realize there's not probably statistical significance to the studies individually, or even in aggregate.

我意識到這些研究單獨或什至總體上可能沒有統計意義。

But is the trend in the right direction?

但趨勢是正確的方向嗎？

Yes, it's an interesting question.

是的，這是一個有趣的問題。

We, as you know, these or many of these studies are 12 week efficacy studies.

如您所知，我們這些或其中許多研究是為期 12 週的療效研究。

And we do have longer safety experiences over time, but it would require many more patient years of exposure that we have currently to expect to have the numbers of events that would allow even if we were for example cutting risk in half.

隨著時間的推移，我們確實有更長的安全經驗，但它需要更多耐心的暴露年限，我們目前預計即使我們將風險降低一半，也能允許發生的事件數量。

You still couldn't expect to have any measure of real power for that.

你仍然不能指望為此擁有任何真正的力量。

So, we don't have a formal analysis looking at that, yet.

因此，我們還沒有對此進行正式分析。

When all the data are put together in total for filing, or course, we will have analyzed them at that level.

當所有數據匯總在一起進行歸檔時，或者當然，我們將在該級別對它們進行分析。

But I don't expect to see a lot of benefit when we're talking about such small numbers of events.

但是當我們談論如此少的事件時，我不希望看到很多好處。

This is of course why the very large long-term outcomes trials are required, as you know.

正如您所知，這當然是為什麼需要進行非常大規模的長期結果試驗的原因。

And fundamentally, Geoff, as you can glean from our remarks on the call, we're excited about the data we've seen.

從根本上說，傑夫，正如你可以從我們在電話會議上的評論中了解到的那樣，我們對所看到的數據感到興奮。

We're excited about the role that this medicine could play for patients that are at risk of cardiovascular disease.

我們很高興這種藥物可以為有心血管疾病風險的患者發揮作用。

So, we continue to deliver on this program, and that's what we intend to do.

因此，我們將繼續執行此計劃，這就是我們打算做的。

Chris Raymond, Robert Baird.

克里斯·雷蒙德，羅伯特·貝爾德。

Just another question on 145, if you'll bear with me.

關於 145 的另一個問題，請耐心等待。

Kind of curious, one of the earlier questions in the queue, I think Sean's answer to it, I think I heard you say, Sean, that with respect to the need for the outcomes data and the percent of events, et cetera.

有點好奇，隊列中較早的問題之一，我想肖恩對此的回答，我想我聽到你說，肖恩，關於對結果數據和事件百分比等的需求。

I understand not wanting to give a lot of answers here.

我明白不想在這裡給出很多答案。

But I think I heard you say, Sean, that essentially FDA is looking for something relative to with info on the trajectory of events.

但我想我聽到你說，肖恩，基本上 FDA 正在尋找與事件軌跡信息相關的東西。

Can you expand on that?

你能詳細說說嗎？

What are they mean by that?

他們這是什麼意思？

Is that something new?

那是新東西嗎？

Thanks.

謝謝。

No, that's the term I'm using to try to just convey the fact that I think what occurs in many cases and we all know this from the data that has been published on this issue, is that it can be very difficult to anticipate with accuracy when a sponsor is going to actually complete a post marketing commitment such as an outcomes trial.

不，這是我用來試圖表達這樣一個事實的術語，即我認為在許多情況下會發生什麼，我們都從關於這個問題的已發布數據中知道這一點，這是很難預測的贊助商實際完成營銷後承諾（例如結果試驗）時的準確性。

And I think the agency is keen to understand the time that would elapse between an initial approval based on a surrogate, even a robust surrogate like LDL, and when the outcomes data will become available.

而且我認為該機構很想了解從基於替代品（甚至是像 LDL 這樣強大的替代品）的初步批准到獲得結果數據之間所經過的時間。

So that's why I was using this term of trajectory, meaning can you predict with some reasonable idea when you're going to actually see the data?

所以這就是我使用軌跡這個術語的原因，意思是當你真正看到數據時，你能用一些合理的想法來預測嗎？

Is it going to take 3 years, 5 years, 10 years?

需要3年、5年、10年嗎？

That's meaningful from a regulatory perspective.

從監管的角度來看，這是有意義的。

Tony Butler, Barclays Capital.

托尼·巴特勒，巴克萊資本。

And sticking to 145 just briefly, Sean, would -- again the comment around the FDA, would that necessitate looking not only at Fourier but also one of the other long-term outcome trials as well?

肖恩，短暫地堅持 145 會——再次圍繞 FDA 發表評論，這是否需要不僅關注傅立葉，而且還需要關注其他長期結果試驗之一？

In other words, do both of them collectively, do they get pooled, and would that then therefore need to be disclosed?

換句話說，他們兩個都在一起，他們是否被合併，然後是否需要披露？

And I'm sorry, just one very small housekeeping, and it's really related to Tony.

對不起，只是一個非常小的家務，這真的與托尼有關。

In Q3, you commented about some of the geographies like Brazil and Turkey being negative, claiming that there would be tenders in Q4.

在第 3 季度，您對巴西和土耳其等一些地區發表了負面評論，聲稱第 4 季度將進行招標。

Was that the case for Q4?

Q4 是這樣嗎？

Thanks very much.

非常感謝。

Okay.

好的。

We'll start there with your geographic question, Tony.

托尼，我們將從你的地理問題開始。

Listen, if you look at Q4, Tony, there was actually about a 135% increase between quarter 3 and quarter 4 as the tenders both back in, and these come mainly out of the Middle East and Russia.

聽著，托尼，如果你看一下第四季度，由於招標都重新開始，第三季度和第四季度之間實際上增長了 135%，這些招標主要來自中東和俄羅斯。

So yes, a dramatic growth in that last quarter for the year.

所以是的，今年最後一個季度出現了顯著增長。

Sean?

肖恩？

I'm not sure I completely understood the first part of the question.

我不確定我是否完全理解問題的第一部分。

I think that from an outcomes data perspective, reduction of the cardiovascular events like heart attack, stroke, sudden death, cardiovascular death, the only meaningful study that we will have to address that question is the Fourier outcomes trial.

我認為，從結果數據的角度來看，減少心髒病發作、中風、猝死、心血管死亡等心血管事件，我們必須解決這個問題的唯一有意義的研究是傅立葉結果試驗。

It's properly designed and powered to read that sort of thing out.

它經過適當的設計和供電，可以讀出那種東西。

Certainly, there are combined analyses that are done across all of the studies that are performed in any of these development programs to look for generally adverse effects, including, if you saw, events traveling the wrong direction that would obviously be a concern.

當然，在任何這些開發項目中進行的所有研究都進行了綜合分析，以尋找普遍的不利影響，包括，如果你看到，顯然會引起關注的錯誤方向的事件。

So those analyses are always done more from the perspective of assuring safety than in trying to look for an efficacy signal.

因此，這些分析總是更多地從確保安全性的角度進行，而不是試圖尋找療效信號。

Geoff Meacham, JPMorgan.

傑夫·米查姆，摩根大通。

Got a couple of P&L questions.

有幾個損益問題。

You guys have made a ton of progress on the pipeline with a lot of readouts this year.

你們今年在管道上取得了很多進展，有很多讀數。

I just wanted to get your perspective on what this means to pre commercial spend on the SG&A line, and R&D as well.

我只是想听聽您對這對 SG&A 系列以及研發的商業前支出意味著什麼的看法。

And then the other revenue line has grown incrementally higher over the past couple quarters, just wanted to get a sense for the constituents and the sustainability of that looking forward.

然後其他收入線在過去幾個季度中逐漸增長，只是想了解未來的成分和可持續性。

Thanks.

謝謝。

Yes, Geoff, we provided the guidance for 2014 at the top line and EPS.

是的，傑夫，我們在頂線和每股收益方面提供了 2014 年的指導。

We weren't planning to get into detail of expense line item by line item.

我們不打算逐行詳細了解費用行項目。

But based on my comments about operating income growth, you can expect that we expect to see operating income leverage this year, again, driven by the $800 million contribution from Enbrel.

但根據我對營業收入增長的評論，您可以預期，在 Enbrel 的 8 億美元貢獻的推動下，我們預計今年將再次出現營業收入槓桿。

And with respect to other income, Michael do you want to add any insights for Jeff?

關於其他收入，Michael 你想為 Jeff 添加任何見解嗎？

I'd just say on a historical run rate basis, other revenue has been $300 million to $400 million a year, and with the addition of Onyx it will just about double.

我只想說，以歷史運行率為基礎，其他收入每年為 3 億至 4 億美元，加上 Onyx，它只會翻一番。

Not quite, but just about double.

不完全是，但大約是兩倍。

Ravi Mehrotra, Credit Suisse.

Ravi Mehrotra，瑞士信貸。

Bob, you talked about the notable international expansion you've had over the last couple of years.

鮑勃，你談到了過去幾年你的顯著國際擴張。

Can you take us through further expansion plans from a geographical perspective, your preference of organic versus M&A to do that?

您能否從地理角度為我們介紹進一步的擴張計劃，您更喜歡有機還是併購來做到這一點？

And linked to that whole commercial organization platform, for biosimilars would you commercialize those globally through the Amgen commercial branded platform, or a separate entity?

並鏈接到整個商業組織平台，對於生物仿製藥，您會通過 Amgen 商業品牌平台或單獨的實體在全球範圍內將其商業化嗎？

Thank you.

謝謝你。

Sure, thanks, Ravi.

當然，謝謝，拉維。

You're right to point out that international expansion has been an important objective for us.

您指出國際擴張一直是我們的重要目標是對的。

We see that as a source of long-term growth for Amgen, and we've talked in particular about our desire to expand into Japan, China, and selected emerging markets.

我們認為這是安進公司長期增長的源泉，我們特別談到了我們向日本、中國和選定的新興市場擴張的願望。

And so far, we've been successful we feel in doing that through a combination of partnerships and acquisitions.

到目前為止，我們已經成功地通過合作夥伴關係和收購的結合來做到這一點。

Obviously, in Japan, China, and Russia, we used partnerships to help advance our interest, and we've used acquisitions in Brazil, Turkey, and now with the reacquisition of Neupogen and Neulasta rights in a number of other key emerging markets as well.

顯然，在日本、中國和俄羅斯，我們利用合作夥伴關係來幫助提升我們的利益，我們在巴西、土耳其進行了收購，現在還重新收購了 Neupogen 和 Neulasta 在許多其他主要新興市場的權利.

So I think we feel we have a strong platform now from which to profitably expand in these international markets.

所以我認為我們覺得我們現在擁有一個強大的平台，可以從中在這些國際市場上實現盈利擴張。

So we have a presence from which we can organically launch our molecules in nearly all of the international markets that are of interest and we think important for the kind of medicines we're advancing.

因此，我們有一個存在，我們可以在幾乎所有感興趣的國際市場上有機地推出我們的分子，我們認為這對我們正在推進的藥物種類很重要。

We'll look to supplement our position with ongoing acquisitions, Ravi, but I think there aren't many and so we're right now executing against our organic plans.

我們將尋求通過正在進行的收購來補充我們的地位，拉維，但我認為沒有很多，所以我們現在正在執行我們的有機計劃。

And with respect to biosimilars, again, our first launches for biosimilars begin in 2017, so there's still quite some time before we have to commit to specific answers to your question, but we think that our biosimilar portfolio will be an attractive source of growth for Amgen, particularly internationally.

關於生物仿製藥，同樣，我們的生物仿製藥首次發佈於 2017 年，因此我們還需要相當長的時間才能對您的問題做出具體回答，但我們認為我們的生物仿製藥產品組合將成為有吸引力的增長來源Amgen，尤其是在國際上。

So where we look at international markets it's likely that it will be through the Amgen organization, and in the more developed markets, we still have time before we disclose exactly how we want to do that.

因此，在我們著眼於國際市場的地方，它很可能會通過 Amgen 組織，而在更發達的市場中，我們仍有時間披露我們想要如何做到這一點。

Matt Roden, UBS.

馬特·羅登，瑞銀。

A lot of the big picture questions have been taken, so I'm going to hit you with a nerdy one for Sean maybe.

已經回答了很多大問題，所以我可能會為 Sean 用一個書呆子的問題來打擊你。

It's on Kyprolis, the ASPIRE trial.

它在 Kyprolis 上，即 ASPIRE 試驗。

Can you remind us when the last interim data monitoring committee analysis was done on safety for ASPIRE?

您能否提醒我們上一次中期數據監測委員會對 ASPIRE 安全性的分析是什麼時候進行的？

And at what threshold difference in cardiovascular events would cause the stoppage on safety?

心血管事件的閾值差異在多大時會導致安全停工？

I'm just trying to get a sense for how to interpret what you've said earlier about the DMC findings.

我只是想了解如何解釋您之前所說的有關 DMC 調查結果的內容。

And then, just related if there are any updates on the ENDEAVOR and CLARION trials ongoing.

然後，如果正在進行的 ENDEAVOR 和 CLARION 試驗有任何更新，則與此相關。

Yes, so, I don't have on the top of my head the last ASPIRE DSMB review.

是的，所以，我沒有想到上次 ASPIRE DSMB 審查。

These typically will occur in these kind of trials on a quarterly basis often.

這些通常會經常每季度發生在此類試驗中。

And -- but I don't know off the top of my head when the most recent one was.

而且 - 但我不知道最近一次是什麼時候。

And there are no specific stopping rules in these regarding cardiovascular events, they're a overall assessment that the risk benefit of the product continues to look appropriate to a very seasoned DSMB who understand the disease and so on.

這些關於心血管事件沒有具體的停止規則，它們是一種總體評估，即該產品的風險收益對於了解該疾病等的經驗豐富的 DSMB 來說仍然是合適的。

There really aren't any updates to give on ENDEAVOR and CLARION, and they're in an enrollment phases, and there's not too much to say about those right now.

關於 ENDEAVOR 和 CLARION，確實沒有任何更新可以提供，它們正處於註冊階段，現在沒有太多要說的。

Eun Yang, Jefferies.

恩陽，傑富瑞。

Question on AMG 145, so you just said the trials were conducted in various patient populations, and according to clinicaltrials.gov outcomes data is not coming out until 2018.

關於 AMG 145 的問題，你剛才說試驗是在不同的患者人群中進行的，根據 clinicaltrials.gov，結果數據要到 2018 年才會出來。

So without outcomes data, are those patient population approval indications?

那麼，如果沒有結果數據，這些患者群體是否符合批准適應症？

And if not, what would be the reason of a indication that you couldn't go after with that prior to outcomes data?

如果不是，那麼表明您無法在結果數據之前進行處理的原因是什麼？

So, the first thing I'd point out is that the kind of date that gets put on .gov is a very crude estimate of when one would expect an event driven trial to complete, and it's often done by a straight line linear modeling, which is rarely actually accurate in terms of what happens the best you can do when you start out from the very beginning estimating that.

所以，我要指出的第一件事是，放在 .gov 上的日期是一個非常粗略的估計，估計人們期望事件驅動的試驗何時完成，而且通常是通過直線線性模型完成的，當你從一開始就開始估計時，就你能做的最好的事情而言，這很少是準確的。

So I wouldn't pin too much on that exact date when it's that far out into the future.

所以我不會過多地確定那個確切的日期，因為它是遙遠的未來。

It may take longer, it may take less, considerably less time.

它可能需要更長的時間，也可能需要更少的時間，相當短的時間。

The issue of the approvability of the various subgroups, we do study populations in our clinical trials, sometimes for purposes of being able for example to understand in a very clean background way, on a really clean background, safety for example.

關於不同亞組的認可度問題，我們在臨床試驗中研究人群，有時是為了能夠以非常乾淨的背景方式，在非常乾淨的背景下，例如安全性，來理解。

And not all of the populations that we studied, and we've studied a very broad range of populations, may end up as specific language and indications for a product like this.

並不是我們研究的所有人群，我們研究的人群範圍非常廣泛，最終可能會成為此類產品的特定語言和適應症。

In fact, if you look at the statin class, you won't find that.

事實上，如果你查看他汀類藥物，你不會發現這一點。

You won't find that, and I think the way I always think about this is this product is going to be appropriate for individuals who have high cardiovascular risk, despite having availed themselves of all available existing therapies, particularly statins, and still have a substantial modifiable risk factor in the form of LDL that's not let's say below 70 where it generally you would feel that you had it under pretty good control.

你不會發現，我認為我一直認為這個產品將適合心血管風險高的人，儘管他們已經利用了所有可用的現有療法，特別是他汀類藥物，並且仍然有LDL 形式的大量可修改風險因素，我們不會說低於 70，通常您會覺得自己控制得很好。

I think that's the population that we're seeking to serve.

我認為這就是我們要服務的人群。

And -- but it is -- you won't usually find very specific indication statements for each individual population in the labels of these products.

而且——但確實如此——你通常不會在這些產品的標籤中找到針對每個個體人群的非常具體的指示說明。

Howard Liang, Leerink Partners.

Howard Liang，Leerink Partners。

AMG 785 or romosuzumab, I think the phase III that was published in Internal Medicine has a retreatment component.

AMG 785 或 romosuzumab，我認為發表在 Internal Medicine 上的 III 期具有再治療成分。

When do we see data from the retreatment?

我們什麼時候能看到撤退的數據？

So when I say retreatment data, I noticed I think you were testing a couple of different formulations.

因此，當我說再處理數據時，我注意到我認為您正在測試幾種不同的配方。

Can you give us some color on that?

你能給我們一些顏色嗎？

So, we often do in phase II a wide range of things with the therapeutics, where we can begin to get some understanding of issues like withdrawal, retreatment, and so on.

因此，我們經常在 II 期進行廣泛的治療，我們可以開始對戒斷、再治療等問題有一些了解。

And so, we do have some features like that in the long-term extensions of these phase II studies.

因此，在這些 II 期研究的長期擴展中，我們確實有一些類似的特徵。

They don't necessarily predict claims that we would be seeking by doing phase III type studies.

他們不一定能預測我們將通過進行 III 期類型研究尋求的主張。

As you can imagine in this field with fracture endpoints being required, that it's very difficult to do ornate studies that require fracture endpoints beyond just what we're already doing with two large fracture studies that will perform with the product.

正如您可以想像的那樣，在這個需要骨折終點的領域，除了我們已經在使用該產品進行的兩項大型骨折研究之外，很難進行需要骨折終點的華麗研究。

The product has got no particularly unusual formulation issues associated with it.

該產品沒有與之相關的特別不尋常的配方問題。

It's an injectable monoclonal antibody, and we're doing the usual things with that with respect to both formulation and device formats.

它是一種可注射的單克隆抗體，我們在配方和設備格式方面都在做通常的事情。

Joel Sendek, Stifel.

喬爾森德克，Stifel。

I have a follow-on question to the biosimilar topic regarding the 2017 launch.

我有一個關於 2017 年上市的生物仿製藥主題的後續問題。

I'm wondering if you could share with us some of your assumptions behind that time frame to get there?

我想知道您是否可以與我們分享您在那個時間框架背後的一些假設？

For example, which of the three biosimilars are you contemplating?

例如，您正在考慮三種生物仿製藥中的哪一種？

Or all three of them?

還是他們三個都這樣？

And is there is the potential to accelerate that time frame?

是否有可能加快該時間框架？

And is it contingent at all upon FDA guidance to industry?

它是否完全取決於 FDA 對行業的指導？

Thank you.

謝謝你。

Sure, Joe, maybe we'll take a couple different cuts at this.

當然，喬，也許我們會對此採取一些不同的削減措施。

Just again to remind you, we have six programs under way, three of which are in pivotal trials.

再次提醒您，我們有六個項目正在進行中，其中三個處於關鍵試驗階段。

Our plan is to try to be first or certainly among the first few for these as they're -- as patents expire around the globe, we seek to be ready to launch a biosimilar product.

我們的計劃是努力成為第一名，或者肯定是前幾名——隨著全球專利到期，我們尋求準備推出生物仿製藥產品。

So, that's true in 2017, and I don't think we're going to get into specific details at this stage about which products we're launching in which jurisdictions when, but generally our strategy is to seek to be first and among the first few for these molecules.

所以，這在 2017 年是正確的，我不認為我們會在這個階段詳細說明我們在什麼時候在哪些司法管轄區推出哪些產品，但總的來說，我們的戰略是尋求成為第一名並躋身於這些分子的前幾個。

And so far, the progress in advancing them through pivotal trials is proceeding in line with our expectation, and the remaining three we expect to move forward during the course of the year as well.

到目前為止，通過關鍵試驗推進它們的進展符合我們的預期，我們預計其餘三個試驗也將在年內推進。

Sean, do you want talk about guidelines from FDA on advancing?

肖恩，你想談談 FDA 關於推進的指導方針嗎？

I think that it's fair to point out that this is unchartered territory, and a new area, and there may be issues that we don't anticipate.

我認為可以公平地指出這是一個未知領域，一個新領域，可能存在我們沒有預料到的問題。

However at this point, we wouldn't engage in enrolling pivotal trials for registration of these products if we didn't have a pretty good sense that there's a roadmap.

然而，在這一點上，如果我們沒有很好地意識到有一個路線圖，我們就不會參與註冊這些產品的關鍵試驗。

And so, obviously there's the usual dynamics, which always takes longer than we all can imagine to do these things like enroll trials, and get the data, and file, and get it reviewed, and get the product to market.

因此，顯然存在通常的動態，這總是比我們所有人想像的要花更長的時間來做這些事情，比如註冊試驗、獲取數據、歸檔、審查，以及將產品推向市場。

But in some ways, a lot of that is based on fairly standard approaches to looking at those kind of timelines.

但在某些方面，其中很多是基於相當標準的方法來查看這些時間表。

Marvin, let's go ahead and take one last question if there is one.

Marvin，如果有的話，讓我們繼續最後一個問題。

Gene Mack, Brean Capital.

Gene Mack，Brean Capital。

I wonder if there's any update you can give for us on oprozomib where the compound stands at this point, and what next steps might be in 2014 in terms of development?

我想知道您是否可以為我們提供有關 oprozomib 的任何最新信息，該化合物目前處於什麼位置，以及 2014 年在開發方面可能採取哪些後續步驟？

Thanks.

謝謝。

So oprozomib is, as you know, the oral proteasome inhibitor which is in development at Onyx, and it is sort of at a phase II A stage of development where it's still in relatively small numbers of patients.

因此，正如您所知，oprozomib 是 Onyx 正在開發的口服蛋白酶體抑製劑，它處於 II A 期開發階段，患者數量仍然相對較少。

And we're understanding the various things you do at that stage in terms of how well tolerated it is as a monotherapy formulations that we play around with, combinations with some of the things that we know that it would have to be combined with.

我們正在了解您在那個階段所做的各種事情，作為我們使用的單一療法配方的耐受性，以及我們知道它必須與之結合的一些東西的組合。

So, a lot of work that is aside from the fact that it's an oral versus an intravenous agent, is relatively straightforward from the perspective of what comparing it to the work that was done by Onyx with Kyprolis.

因此，從將其與 Onyx 與 Kyprolis 所做的工作進行比較的角度來看，除了它是口服藥物還是靜脈注射藥物這一事實之外，很多工作都相對簡單。

Great, thanks, Sean.

太好了，謝謝，肖恩。

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

我還要感謝大家今天下午參加我們的電話會議。

If you have any additional questions, of course we can continue the dialogue separately.

如果大家還有什麼問題，當然我們可以單獨繼續對話。

Thanks again.

再次感謝。

Ladies and gentlemen, thank you for joining us for today's Amgen fourth quarter and full-year 2013 financial results conference call.

女士們，先生們，感謝你們參加今天的安進第四季度和 2013 年全年財務業績電話會議。

We thank you for your participation.

我們感謝您的參與。

You may all disconnect.

你們都可以斷開連接。