美國安進 (AMGN) 2014 Q3 法說會逐字稿

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

我叫馬文，今天我將擔任安進第三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。

Thank you, Marvin.

謝謝你，馬文。

Good afternoon, everybody.

大家下午好。

I would like to welcome you to our third-quarter conference call.

歡迎您參加我們的第三季度電話會議。

Unlike past quarters, our format today will be a bit different.

與過去幾個季度不同，我們今天的形式會有所不同。

As we are conducting a comprehensive business review tomorrow morning, we will limit our comments to reviewing our solid performance during the third quarter, and keep this call brief, to about 30 minutes, including taking some of your questions.

由於我們明天早上將進行全面的業務審查，因此我們將把我們的評論限制在審查我們在第三季度的穩健表現上，並將本次電話會議的時間保持在 30 分鐘左右，包括回答您的一些問題。

Joining me today are Bob Bradway, our Chairman and CEO, and our CFO, David Meline, who will both make some prepared comments outlining our operating performance during the quarter.

今天加入我的是我們的董事長兼首席執行官 Bob Bradway 和我們的首席財務官 David Meline，他們都將發表一些準備好的評論，概述我們在本季度的經營業績。

Tony Hooper, who as you know is our Head of Global Commercial Operations, and Sean Harper, our Head of our R&D, are also here with us to address any questions you might have for them.

如您所知，我們的全球商業運營主管托尼·胡珀 (Tony Hooper) 和我們的研發主管肖恩·哈珀 (Sean Harper) 也與我們一起解決您可能向他們提出的任何問題。

To further help with the understanding of product sales drivers, we have posted some slides on our website.

為了進一步幫助了解產品銷售驅動因素，我們在我們的網站上發布了一些幻燈片。

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

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

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

因此，我想將電話轉給 Bob。

Bob?

鮑勃？

Thanks, Arvind.

謝謝，阿文德。

Good afternoon, everyone, and thank you for joining us to discuss our strong third-quarter results.

大家下午好，感謝您加入我們討論我們強勁的第三季度業績。

As Arvind indicated, David Meline and I will offer some brief commentary in context of the quarter, and then we will take some questions together with Tony and Sean.

正如 Arvind 指出的那樣，David Meline 和我將就本季度的背景提供一些簡短的評論，然後我們將與 Tony 和 Sean 一起回答一些問題。

Again, just to reiterate, since we're meeting tomorrow morning for a comprehensive business review, we will really try to keep the focus for this call on our quarterly results.

再次重申，由於我們明天早上要開會進行全面的業務審查，我們真的會努力將本次電話會議的重點放在我們的季度業績上。

Our third-quarter results just announced reflect strong sales performance across the portfolio, which, when combined with our ongoing expense discipline, generated 22% growth in operating income, and 19% growth in earnings per share.

我們剛剛公佈的第三季度業績反映了整個產品組合的強勁銷售業績，再加上我們持續的費用控制，營業收入增長了 22%，每股收益增長了 19%。

Given the strategic emphasis we've placed on growing our international presence, we were particularly pleased with the 14% growth in international sales during the quarter.

鑑於我們將戰略重點放在擴大國際影響力上，我們對本季度國際銷售額增長 14% 感到特別滿意。

Consistent with the strong underlying prescription trends that we've seen through the first three quarters of the year, our product sales performance for the third quarter was up 4% year-over-year.

與我們在今年前三個季度看到的強勁的潛在處方藥趨勢一致，我們第三季度的產品銷售業績同比增長 4%。

If you recall, however, last year, we recognized a $155 million government order for Neupogen that was reflected in our Q3 2013 results.

然而，如果您還記得的話，去年我們確認了 1.55 億美元的 Neupogen 政府訂單，這反映在我們 2013 年第三季度的業績中。

Sales grew 8% year-over-year, excluding that one-time order from last year.

銷售額同比增長 8%，不包括去年的一次性訂單。

Overall, then, the Q3 performance was strong across-the-board, and on a year-to-date basis, revenues have increased 8%, with operating income increasing 24%, reflecting our improving margin structure.

總的來說，第三季度的表現全面強勁，從年初至今，收入增長了 8%，營業收入增長了 24%，反映出我們不斷改善的利潤結構。

In a moment, David will review the drivers of our key products and the financials in more detail, but as you know, R&D is the engine that will drive future growth at Amgen, and we continue to make good progress in advancing our registration programs, so I'll say a few words about those.

稍後，David 將更詳細地回顧我們關鍵產品的驅動因素和財務狀況，但如您所知，研發是推動安進未來增長的引擎，我們將繼續在推進註冊計劃方面取得良好進展，所以我會就這些說幾句話。

We reported positive Phase III results from three innovative programs in the quarter, the second positive study for AMG 416, which is our intravenous calcimimetic, which performed well in a study versus placebo.

我們報告了本季度三個創新項目的積極 III 期結果，這是 AMG 416 的第二個積極研究，這是我們的靜脈內擬鈣劑，在一項研究中與安慰劑相比表現良好。

The Kyprolis ASPIRE study, which generated exceptional progression-free survival data in the relapsed myeloma setting, as well as Evolocumab data in Japan, which is also an important opportunity for us.

Kyprolis ASPIRE 研究在復發性骨髓瘤環境中產生了出色的無進展生存數據，以及日本的 Evolocumab 數據，這對我們來說也是一個重要的機會。

We submitted marketing authorizations for four programs in the quarter, with Ivabradine in the US, Evolocumab, Blinatumomab, and T-Vec in the US and EU, with both Ivabradine and Blinatumomab currently under priority review by the FDA.

我們在本季度提交了四個項目的營銷授權，包括美國的伊伐布雷定、美國和歐盟的 Evolocumab、Blinatumomab 和 T-Vec，伊伐布雷定和 Blinatumomab 目前正在接受 FDA 的優先審查。

We also announced the first positive Phase III results for one of our biosimilar programs, that being ABP 501 in psoriasis, as we prepare to begin launching our biosimilar portfolio beginning in 2017.

當我們準備從 2017 年開始推出我們的生物仿製藥組合時，我們還宣布了我們的一個生物仿製藥項目的第一個積極的 III 期結果，即銀屑病的 ABP 501。

We'll talk about strategy tomorrow, and we look forward to providing more granularity on our progressing pipeline, our commercial plans for launching new products, our capital allocation plans, our business transformation initiatives and progress, as well as an update on our biosimilar and manufacturing activities.

我們明天將討論戰略，我們期待提供更多關於我們正在進行的管道、我們推出新產品的商業計劃、我們的資本分配計劃、我們的業務轉型計劃和進展，以及我們的生物仿製藥和製造活動。

Now, let me turn to David, who will walk you through the financials, and then we will open it up for questions.

現在，讓我轉向大衛，他將向您介紹財務狀況，然後我們將公開提問。

Okay.

好的。

Thanks, Bob.

謝謝，鮑勃。

I want to take a moment to first briefly discuss the key drivers of product sales performance, during the quarter.

我想花點時間首先簡要討論本季度產品銷售業績的主要驅動因素。

Enbrel units grew 3% year-over-year, and 5% quarter-over-quarter, reflecting strong underlying demand, as is reflected in the prescription data.

Enbrel 單位同比增長 3%，環比增長 5%，反映出強勁的潛在需求，這在處方數據中有所體現。

I'd also like to point out that Enbrel continues to see strong segment growth in both rheumatology and dermatology, at 21% and 24% respectively.

我還想指出，Enbrel 在風濕病學和皮膚病學領域繼續保持強勁增長，分別達到 21% 和 24%。

Recall last quarter that we called out $60 million of Enbrel inventory build in Q2, that we expected to burn off in Q3, masking the strength in demand.

回想一下上個季度，我們在第二季度提出了 6000 萬美元的 Enbrel 庫存建設，我們預計這些庫存將在第三季度消耗殆盡，從而掩蓋了需求的強勁勢頭。

Prolia sales increased 43% in the quarter, due to strong unit demand.

由於單位需求強勁，本季度 Prolia 的銷售額增長了 43%。

As you are aware, we normally see some seasonality in Prolia in Q3, and we saw the expected sales ramp up as we exited the quarter.

如您所知，我們通常會在第 3 季度看到 Prolia 的一些季節性因素，並且在我們退出該季度時我們看到了預期的銷售增長。

We continue to capture share in a growing market with XGEVA, and despite generic competition over the past year, XGEVA sales increased 22%.

我們繼續通過 XGEVA 在不斷增長的市場中佔據份額，儘管過去一年存在仿製藥競爭，但 XGEVA 的銷售額增長了 22%。

Our newest product, Kyprolis, realized sequential sales growth of 21% to $94 million, much of which was driven by strong unit demand.

我們的最新產品 Kyprolis 實現了 21% 的連續銷售額增長，達到 9400 萬美元，其中大部分是由強勁的單位需求推動的。

We remain confident that Kyprolis will become the proteasome inhibitor of choice, and you will have the opportunity to hear from Pablo Cagnoni, who leads our Onyx business, tomorrow.

我們仍然相信 Kyprolis 將成為首選的蛋白酶體抑製劑，明天您將有機會聽到我們 Onyx 業務負責人 Pablo Cagnoni 的消息。

Finally, I would also like to highlight Vectibix, which grew 29% year-over-year, on the strength of our new first-line label in the US, as well as growth in the EU.

最後，我還想強調 Vectibix，它同比增長 29%，這得益於我們在美國的新一線品牌以及在歐盟的增長。

Let me now make a few brief comments on our operating performance.

現在讓我對我們的經營業績做一些簡短的評論。

Our operating expenses declined 5%, due to Enbrel's improved profitability from the expired profit-share agreement, as well as due to efforts to manage cost.

我們的運營費用下降了 5%，這是由於 Enbrel 從到期的利潤分成協議中提高了盈利能力，以及由於努力管理成本。

This led to a 47% operating margin, a 7-point increase, compared to the third quarter of 2013.

這導致營業利潤率為 47%，與 2013 年第三季度相比增加了 7 個百分點。

Based on our progress through the first nine months of the year, and our confidence in the underlying trends of the business, we are again raising our 2014 revenue guidance to $19.8 billion to $20 billion, and our 2014 adjusted EPS guidance to $8.45 to $8.55 per share.

基於我們今年前 9 個月的進展以及我們對業務基本趨勢的信心，我們再次將 2014 年收入指引上調至 198 億美元至 200 億美元，並將 2014 年調整後每股收益指引上調至 8.45 至 8.55 美元分享。

I would also like to provide a brief update on our transformation actions.

我還想簡要介紹一下我們的轉型行動。

At the time of our announcement in July, we estimated a headcount reduction of 12% to 15% of our global work force, or 2,400 to 2,900 staff.

在我們 7 月份發佈公告時，我們估計全球員工人數將減少 12% 至 15%，即 2,400 至 2,900 名員工。

We have now completed and largely implemented the adjustment, with a confirmed total in excess of 2,900 reductions.

我們現在已經完成並基本實施了調整，確認總計減少了 2,900 多個。

On a US GAAP basis, restructuring charges totaled $376 million in the third quarter.

根據美國公認會計原則，第三季度重組費用總計 3.76 億美元。

We now expect the total cost of this action to be $835 million to $885 million through 2015, including an estimated $150 million charge in Q4 of 2014.

我們現在預計，到 2015 年，這項行動的總成本將達到 8.35 億美元至 8.85 億美元，其中包括 2014 年第四季度估計的 1.5 億美元費用。

We are also updating our guidance for the 2014 tax rate today.

今天，我們還更新了 2014 年稅率指南。

Based on uncertainty concerning the timing for the extension of the R&D tax credit within the 2014 calendar year, we have chosen to remove the benefit from our projected 2014 adjusted tax rate, resulting in guidance of 16% to 17% for this year, versus our previous guidance of 15% to 16%.

基於在 2014 日曆年內延長研發稅收抵免的時間不確定性，我們選擇從我們預計的 2014 年調整後稅率中去除收益，導致今年的指導值為 16% 至 17%，而我們的預期為先前的指導為 15% 至 16%。

We also saw in the quarter a $1 billion increase in free cash flow to $2.6 billion, reflecting the benefit of higher product sales and ongoing improvements in working capital.

本季度我們還看到自由現金流增加了 10 億美元，達到 26 億美元，這反映了產品銷售額增加和營運資金持續改善的好處。

Our cash balance increased $1.6 billion over the previous year, now totaling $28.1 billion.

我們的現金餘額比上一年增加了 16 億美元，目前總計 281 億美元。

Our debt balance of $33 billion is $5.8 billion higher versus Q3 of 2013, due to debt related to the Onyx acquisition.

由於與 Onyx 收購相關的債務，我們的債務餘額為 330 億美元，比 2013 年第三季度高出 58 億美元。

That completes our review of the quarter.

我們對本季度的回顧到此結束。

I will now turn the call back to Arvind for Q&A.

我現在將把電話轉回給 Arvind 進行問答。

Excellent, thank you David.

太好了，謝謝大衛。

Marvin, let's go ahead and open up Q&A and let's do that for about the next 15 to 20 minutes, if you want to start out by reviewing the procedure again for asking questions?

Marvin，讓我們繼續進行問答，讓我們在接下來的 15 到 20 分鐘內這樣做，如果你想再次回顧提問的程序開始嗎？

(Operator Instructions) Eric Schmidt, Cowen and Company.

（操作員說明）Eric Schmidt、Cowen and Company。

Thanks a lot for taking my question, and congrats on a really strong performance in Q3.

非常感謝您提出我的問題，並祝賀您在第三季度取得了非常強勁的表現。

I guess the question is for David, on the guidance.

我想這個問題是針對大衛的，關於指南。

Even with the bumped up tax rate in 2014 if you hit your revenue guidance for the fourth quarter, it implies a pretty big decrease in operating margins.

即使 2014 年的稅率有所提高，如果您達到了第四季度的收入目標，這也意味著營業利潤率會大幅下降。

Just wondering what might be behind that?

只是想知道這背後可能是什麼？

Yes, Eric.

是的，埃里克。

So generally, what we see in the fourth quarter is a pick up of expenses.

所以總的來說，我們在第四季度看到的是支出的回升。

It's a seasonal trend that occurseach year.

這是每年都會出現的季節性趨勢。

And so what we're expecting is a similar pick up here in Q4.

因此，我們期待的是在第四季度這裡出現類似的回升。

So I think, nothing unusual, but there's certainly some additional costs in Q4.

所以我認為，沒有什麼不尋常的，但第四季度肯定會有一些額外的成本。

Eric, as you know, we're gearing up for some potential launches next year, including launches that could take place early in the year.

埃里克，如你所知，我們正在為明年的一些潛在發布做準備，包括可能在今年年初進行的發布。

So that will be reflected as well, when get into the fourth quarter OpEx.

因此，當進入第四季度 OpEx 時，這也會反映出來。

Matt Roden, UBS.

馬特·羅登，瑞銀。

Great, thanks very much for taking my questions as well, and congrats on the nice results.

太好了，也非常感謝您回答我的問題，並祝賀您取得了不錯的成績。

So you pointed out the expanding margin here in the second quarter and third quarter.

所以你指出了第二季度和第三季度這裡不斷擴大的利潤率。

Certainly better than it's been in recent years, and we understand that Enbrel profitability is part of that.

當然比近年來更好，我們知道 Enbrel 的盈利能力是其中的一部分。

But these numbers are also ahead of future year estimates, consensus estimates.

但這些數字也超過了未來一年的估計和共識估計。

I want to get a sense for, with the caveat of an uptick of expenses in 4Q, and realizing you can't really give guidance for 2015, at least, today, just want to get a sense for how sustainable you can keep this operating margin level, and to what extent you think you can grow from that new level?

我想了解一下，第四季度費用上升的警告，並意識到你不能真正為 2015 年提供指導，至少，今天，我只是想了解你如何保持這種運營的可持續性利潤水平，您認為您可以從這個新水平增長到什麼程度？

Thank you.

謝謝你。

Thanks for the question, Matt.

謝謝你的問題，馬特。

This is Bob.

這是鮑勃。

That's an important question for us to address tomorrow, and we look forward to addressing it head-on.

這是我們明天要解決的一個重要問題，我們期待著正面解決它。

As you point out, we benefited from an improved profitability at Enbrel, but also from ongoing across the rest of the business, and we'll have lots more to say about that when we get together tomorrow.

正如您所指出的，我們受益於 Enbrel 盈利能力的提高，但也受益於整個業務的持續發展，明天我們聚在一起時，我們將有更多話要說。

Matthew Harrison, Morgan Stanley.

摩根士丹利的馬修哈里森。

Great, thanks for taking my question.

太好了，謝謝你提出我的問題。

I just wanted to ask a two-parter on Enbrel.

我只是想問一個關於 Enbrel 的二人組。

First, in the slides, you gave price and inventory, and if you look at inventory, I know you called out the $60 million headwind that you face this quarter.

首先，在幻燈片中，你給出了價格和庫存，如果你看一下庫存，我知道你指出了本季度你面臨的 6000 萬美元逆風。

It looks like it was about, by your slide, about $110 million, so you expect some inventory to reverse in the fourth quarter.

從你的幻燈片來看，它看起來大約是 1.1 億美元，所以你預計第四季度會有一些存貨回升。

And then the second, you've taken two 7% price increases this year, yet you only shared about 1% year-over-year price bump.

然後第二個，你今年已經兩次提價 7%，但你只分享了大約 1% 的同比價格上漲。

Is that because you give most of the price back in terms of the contract, or could you just talk a little bit about that, too?

那是因為你根據合同退還了大部分價格，還是你也可以談談這個？

Thanks.

謝謝。

Sure, Matt.

當然，馬特。

Why don't we ask Tony to address those two questions?

我們為什麼不請託尼解決這兩個問題呢？

Go ahead, Tony.

來吧，托尼。

Matt, the two questions -- you are correct, we actually entered the quarter carrying about $60 million.

馬特，這兩個問題——你是對的，我們實際上進入了這個季度大約有 6000 萬美元。

Inventory is fairly normal during the week, but months and quarters tend to land in different places in that week, which causes some shifting up-and-down.

庫存在一周內相當正常，但月份和季度往往會在該週出現在不同的地方，這會導致一些上下波動。

So in addition to the $60 million we carried into the quarter that we had to burn off, we actually closed the quarter at an unusually low level of inventory, with about $40 million reduced inventory.

因此，除了我們必須燒掉本季度的 6000 萬美元外，我們實際上以異常低的庫存水平結束了本季度，庫存減少了約 4000 萬美元。

So that $100 million will correctly flow into the fourth quarter.

因此，這 1 億美元將正確地流入第四季度。

I think the price number that you are seeing for the third quarter, there's a lot of ins and outs in this calculation, and I don't think you can take this as a true reflection of the net impact of price that we are applying in the marketplace.

我認為你看到的第三季度的價格數字，在這個計算中有很多細節，我認為你不能把它當作我們在應用中應用的價格淨影響的真實反映市場。

Marvin, let's take the next question, please.

馬文，我們來回答下一個問題。

Robyn Karnauskas, Deutsche Bank.

Robyn Karnauskas，德意志銀行。

Great, congratulations.

太好了，恭喜。

This is Mohit Bansal for Robyn Karnauskas.

我是 Robyn Karnauskas 的 Mohit Bansal。

Thanks for taking my question, and congratulations on a good quarter.

感謝您提出我的問題，並祝賀您度過了一個愉快的季度。

My question is regarding Enbrel.

我的問題是關於 Enbrel 的。

So given that the decent launch of Otezla in psoriasis and psoriatic arthritis, are you seeing any impact on Enbrel's space?

因此，鑑於 Otezla 在銀屑病和銀屑病關節炎中的良好上市，您是否看到對 Enbrel 空間的任何影響？

And then you talked about geographical mix bringing up the tax rate.

然後你談到了提高稅率的地域組合。

So just wanted to get some sense of how should we think about it in the future?

所以只是想了解一下我們將來應該如何考慮它？

Thanks.

謝謝。

I think there are two separate questions there, we will have David obviously, to address the second.

我認為那裡有兩個不同的問題，顯然我們將請 David 來解決第二個問題。

Tony, do you want to tackle the first?

托尼，你想解決第一個問題嗎？

Okay.

好的。

So the product you are talking about was launched into psoriasis in late September, so the actual data we have available is fairly light at the moment.

所以你說的產品是在 9 月下旬推出的牛皮癬產品，所以我們目前可用的實際數據相當少。

I would assume that the fourth quarter will be a bit more robust data around prescriptions.

我認為第四季度的處方數據會更加穩健。

Net-net for the third quarter, we don't see any reduction in the number of new naive patients going on to injectable biologics for psoriasis, and we also don't see any dramatic change in the trend of our market share.

第三季度的淨值，我們沒有看到新的天真患者的數量有任何減少，因為牛皮癬可以注射生物製劑，我們也沒有看到我們的市場份額趨勢有任何顯著變化。

David?

大衛？

In terms of tax rate, so as I mentioned, I think you understood why we took the rate up here in the quarter, and what's going to happen now is, we'll look out and I think best address tomorrow, we have got a piece where I will talk about how to think about taxes going forward, and what are the key drivers of that.

在稅率方面，正如我提到的，我想你明白我們為什麼在這個季度提高稅率，現在要發生的是，我們會注意，我認為明天最好的地址，我們有一個我將在其中討論如何考慮未來的稅收，以及其主要驅動因素是什麼。

So if you don't mind, I'm going to take it up with you in the morning.

所以如果你不介意的話，我會在早上和你一起討論。

Okay.

好的。

Thanks.

謝謝。

Mark Schoenebaum, ISI Group.

ISI 集團的 Mark Schoenebaum。

Thanks for taking the question.

感謝您提出問題。

Looking forward to the update tomorrow.

期待明天的更新。

I have a question for Tony, on Neupogen, would it be possible to in the US, for you to please give us the unit share that Neupogen still enjoys of the short-acting GCSF market, and I noticed on that slide, the impact of price on a year-on-year basis is not in the slide.

我有一個關於 Neupogen 的問題要問 Tony，在美國是否有可能，請您告訴我們 Neupogen 在短效 GCSF 市場中仍然享有的單位份額，我注意到在那張幻燈片上的影響價格同比沒有下滑。

What happened to price on a year-on-year basis?

同比價格發生了什麼變化？

Thank you.

謝謝你。

Mark, price on Neupogen year-on-year is negligible.

馬克，Neupogen 的同比價格可以忽略不計。

That's why it was not actually listed.

這就是為什麼它實際上沒有被列出的原因。

In regard to market share, from a total Filgrastim portfolio, we still hold just over 98% of the market.

就市場份額而言，在 Filgrastim 的全部產品組合中，我們仍然佔據略高於 98% 的市場份額。

In short acting?

簡而言之？

I'll have to get you that number, but actual market share hasn't changed dramatically versus the second quarter.

我必須告訴你這個數字，但實際市場份額與第二季度相比並沒有發生顯著變化。

All right.

好的。

See you tomorrow.

明天見。

Thank you.

謝謝你。

Michael Yee, RBC Capital Markets.

Michael Yee，RBC 資本市場。

Yes, follow-up question on Neupogen as it relates to Neulasta.

是的，關於 Neupogen 的後續問題，因為它與 Neulasta 相關。

I guess, as you are seeing some competitive impacts, you noted that in your slides in the short acting.

我想，當你看到一些競爭影響時，你在幻燈片中註意到了這一點。

How would that be different, if at all, for Neulasta, and what actually happens in terms of losing share?

對於 Neulasta 來說，如果有的話，會有什麼不同，以及在失去份額方面實際發生了什麼？

Is it a price issue, does that just continue?

這是一個價格問題，只是繼續嗎？

What exactly is going on there, and how does that relate to any risk for Neulasta in the future?

那裡到底發生了什麼，這與 Neulasta 未來的任何風險有何關係？

Thanks.

謝謝。

I'm not quite sure of the detail of your question, but obviously, we're seeing Neulasta continue the trend it's had for the last couple of quarters.

我不太確定你問題的細節，但顯然，我們看到 Neulasta 延續了過去幾個季度的趨勢。

We see little to no impact from the recently-launched short-acting Granix.

我們認為最近推出的短效 Granix 幾乎沒有影響。

As you know, we do have long-acting competitor in Europe, and we've seen a fairly small impact from them over the last year or so.

如您所知，我們在歐洲確實有長期存在的競爭對手，在過去一年左右的時間裡，我們看到他們的影響相當小。

Ying Huang, Bank of America Merrill Lynch.

Ying Huang，美銀美林。

Thank you for taking my questions.

謝謝你回答我的問題。

I have a couple.

我有一對。

First one is, you had decent quarterly sales for Epogen, and its growth was primarily driven by price.

第一個是， Epogen 的季度銷售額不錯，其增長主要是由價格驅動的。

So I was wondering if you can talk about the pricing trend in that market, and then, do you expect any competition to come in 2015 in the US or not?

所以我想知道您是否可以談談該市場的定價趨勢，然後，您預計 2015 年美國是否會出現任何競爭？

Then I have a second question for maybe Sean.

然後我有第二個問題可能要問肖恩。

Have you looked at any post-hoc analysis of cardiovascular events in the DESCARTES trial?

您是否看過 DESCARTES 試驗中心血管事件的事後分析？

Okay, so let me respond to your questions.

好的，讓我回答你的問題。

As regard to price, obviously we don't give any forward guidance on price.

至於價格，顯然我們沒有給出任何價格前瞻性指導。

We did take a 4.9% price increase on Epogen in May this year, and based on the contracts we have, some of that flowed through.

今年 5 月，我們確實將 Epogen 的價格上漲了 4.9%，並且根據我們的合同，其中一些已經實現。

As regards to competition, as you know, Mircera has the rights to enter the market effective July 2014, and we do lose patent in May of 2015.

關於競爭，如您所知，Mircera 有權從 2014 年 7 月起進入市場，我們確實在 2015 年 5 月失去了專利。

And regarding the analyses of the cardiovascular events in the Phase III studies, these analyses are performed on some of the longer-term exposure studies, and those are actually published in the literature.

關於 III 期研究中心血管事件的分析，這些分析是在一些長期暴露研究中進行的，這些研究實際上已經發表在文獻中。

There's a paper in circulation where you see about half the rate of cardiovascular events in the Evolocumab arm versus the placebo control arm.

有一篇正在流通的論文，其中您看到 Evolocumab 組的心血管事件發生率大約是安慰劑對照組的一半。

I just caution interpretation around these very small numbers of events.

我只是警告對這些極少數事件的解釋。

It's extremely difficult to know if these are play of chance or a real drug effect.

很難知道這些是偶然的還是真正的藥物作用。

I'll just remind you that the numbers of events that are necessarily generally to evaluate this thing is in the thousands of events, versus double-digit numbers of events.

我只是提醒你，通常需要評估這個東西的事件數量是數千個事件，而不是兩位數的事件數量。

Thank you.

謝謝你。

Yaron Werber, Citigroup.

Yaron Werber，花旗集團。

Great, nice quarter, and also thanks for taking my question.

很棒，不錯的季度，也感謝您提出我的問題。

So Sean, it's a question for you, or I don't know if Tony wants to pick it up.

所以肖恩，這是你的問題，或者我不知道托尼是否願意接聽。

Relating to Evolocumab, so your Phase III actually hit the endpoint using the EMA definition of statin intolerance.

關於 Evolocumab，因此您的 III 期實際上使用 EMA 對他汀類藥物不耐受的定義達到了終點。

Regeneron's compound missed using the US definition, but at this point, you haven't completed your Phase III using the FDA definition of statin intolerance.

Regeneron 的化合物未使用美國定義，但此時，您尚未使用 FDA 對他汀類藥物不耐受的定義完成 III 期研究。

And so my question really has to do with, do you think you can get approved in the US, before that data is generated?

所以我的問題真的與，你認為你能在數據生成之前在美國獲得批准嗎？

Thank you.

謝謝你。

Yes, I think first of all, there has been discussion by companies in this space, both European and the US regulators, but I would not want you to think that there are clear guidances or definitions around this coming from the regulatory agencies.

是的，我認為首先，歐洲和美國監管機構都在這個領域進行過討論，但我不希望你認為監管機構對此有明確的指導或定義。

In fact, they are expressing to us the clear sense that they don't know exactly how to define this population, how to study it, what the study designs would be necessary to actually get specific language around statin intolerance, and it's unclear whether such language is necessary.

事實上，他們向我們表達了一種明確的感覺，即他們不確切地知道如何定義這個人群，如何研究它，研究設計對於實際獲得圍繞他汀類藥物不耐受的特定語言是必要的，並且不清楚這樣是否語言是必要的。

For example, one could define high risk individuals who have not reached LDL treatment goals, despite the use of available therapy, that would cover statin intolerant patients and non-statin intolerant patients, so it's a very difficult area.

例如，儘管使用了可用的治療方法，但仍未達到 LDL 治療目標的高風險個體可以定義，這將涵蓋他汀類藥物不耐受患者和非他汀類藥物不耐受患者，因此這是一個非常困難的領域。

We obviously are exploring different ways of studying this problem, so that we can eventually describe those data, hopefully, in our labeling.

我們顯然正在探索研究這個問題的不同方法，以便我們最終能夠在我們的標籤中描述這些數據。

But it's not as clear a set of guidelines from the regulators as it might appear on first blush.

但監管機構的一套指導方針並不像乍一看那樣清晰。

Terence Flynn, Goldman Sachs.

特倫斯弗林，高盛。

Thanks for taking the question.

感謝您提出問題。

So we know Sandoz filed for approval of a biosimilar version of Neupogen this summer.

所以我們知道 Sandoz 今年夏天申請了 Neupogen 的生物仿製藥版本的批准。

Our team has done some work that suggests additional patents beyond the composition of matter patent could be fairly significant impediments here in the US, for the first biosimilars, just given potential delays or litigation appeals.

我們的團隊所做的一些工作表明，在美國，物質專利之外的其他專利對於首批生物仿製藥來說可能是相當大的障礙，只是考慮到潛在的延誤或訴訟上訴。

So just want to know if you could remind us if you have any additional patents beyond composition for Neupogen and Neulasta, and if we should place any weight on those patents to potentially delay biosimilar entrants?

所以只想知道你是否可以提醒我們，如果你有任何額外的專利，除了 Neupogen 和 Neulasta 的成分，我們是否應該對這些專利施加任何影響以潛在地延遲生物仿製藥進入者？

Thanks.

謝謝。

I know there's been a lot of discussion of that recently in the investment community, and again, it's something that we'll talk about tomorrow.

我知道最近在投資界對此進行了很多討論，同樣，這是我們明天要討論的話題。

But I think as you are aware, we and Sandoz are litigating one intellectual property issue now that relates to your question, and so we'll have an answer from the courts at some point on an important piece of the question that you are asking.

但我認為，正如您所知，我們和 Sandoz 現在正在就一個與您的問題相關的知識產權問題提起訴訟，因此我們將在某個時候從法院獲得關於您提出的一個重要問題的答复。

And generally, we expect that we will face competition for Neupogen through time on the biosimilar pathway in the US, and we also expect that we'll start to see some challenges for the long-acting Neulasta product as well in the US, probably at some point in 2016.

總的來說，我們預計我們將在美國的生物仿製藥途徑上隨著時間的推移面臨 Neupogen 的競爭，我們也預計我們將開始在美國看到長效 Neulasta 產品的一些挑戰，可能在2016年的某個時候。

Marvin, before you move on to the next question, I just wanted to respond to Michael Yee's question about the market share, or about the segment share for Neulasta.

Marvin，在你繼續下一個問題之前，我只想回答 Michael Yee 關於市場份額或 Neulasta 細分市場份額的問題。

On a sequential basis, we actively gained about a percentage point, and also on a year-over-year basis, we gained about a percentage point in terms of unit share on Neulasta.

在連續的基礎上，我們積極地獲得了約一個百分點，並且在同比基礎上，我們在 Neulasta 的單位份額方面獲得了約一個百分點。

Let's take the next question, please.

請讓我們回答下一個問題。

Eun Yang, Jefferies.

恩陽，傑富瑞。

Thank you.

謝謝你。

Question on Kyprolis.

關於 Kyprolis 的問題。

Based on our discussions with the physicians, Kyprolis is being used off-label beyond relapsed and refractory multiple myeloma, so with positive interim ASPIRE data, do you expect to see increases in sales in the next couple of quarters, or do you think the medical community is waiting for all of the data?

根據我們與醫生的討論，Kyprolis 正在用於復發和難治性多發性骨髓瘤以外的標籤外使用，因此根據積極的中期 ASPIRE 數據，您是否預計未來幾個季度的銷售額會增加，或者您認為醫療社區正在等待所有數據？

Thank you.

謝謝你。

This is Tony.

這是托尼。

As you know, the data is quite sparse, so what we do is we do about 1,000 chart audits, and then we do an extrapolation each quarter to determine the market shares.

如您所知，數據非常稀少，所以我們所做的是進行大約 1,000 次圖表審計，然後我們每個季度進行一次推斷以確定市場份額。

As I look at quarter three, we saw a distinctive increase in our market share in third-line.

當我看第三季度時，我們看到我們在三線市場的份額顯著增加。

We also saw an increase in our market share in fourth-line plus.

我們還看到我們在四線以上的市場份額有所增加。

We have not seen a dramatic change in any second-line usage at this particular stage.

在這個特定階段，我們沒有看到任何二線藥物使用發生顯著變化。

We will be presenting the data at ASH, I think the publication will be -- the ASH data will be public on about November 6, and that study, we'll see what happens.

我們將在 ASH 上展示數據，我認為該出版物將是——ASH 數據將在 11 月 6 日左右公開，而這項研究，我們將看看會發生什麼。

But we haven't seen any dramatic change in the marketplace today.

但我們今天還沒有看到市場發生任何顯著變化。

None.

沒有任何。

Josh Schimmer, Piper Jaffray.

喬什·希默，派珀·杰弗瑞。

Thanks for taking my question.

感謝您提出我的問題。

Hoping you can help elucidate the extent to which in relevant territories your own internal projections been able to accurately project biosimilar impact, and then how confident are you that your internal projections, whatever they may be going forward for biosimilar erosion of your mature franchise is really to capture the likely effect?

希望你能幫助闡明在相關領域你自己的內部預測能夠準確預測生物仿製藥影響的程度，然後你對你的內部預測有多大信心，無論它們對你成熟特許經營權的生物仿製藥侵蝕是真的捕捉可能的效果？

So let me respond.

所以讓我回應。

Obviously, there's never been a historical situation in the US that we can actually model anything on.

顯然，美國從來沒有任何歷史情況可供我們實際借鑒。

The competition we have at the moment against Neupogen is of course not a biosimilar competition.

我們目前與 Neupogen 的競爭當然不是生物仿製藥競爭。

We have, however, in Europe looked over the last five to seven years, a large amount of biosimilar competition.

然而，在過去的五到七年裡，我們在歐洲看到了大量的生物仿製藥競爭。

And we have modeled Europe, and it worked successfully to defend our business in Europe for the last five, seven years, so we've done a combination of modeling Europe as a totality, we're taking countries inside Europe that as best as possible would potentially emulate practices or behaviors in the US, and we have use those models to create our long-range plans.

我們對歐洲進行了建模，並且在過去的五、七年裡成功地捍衛了我們在歐洲的業務，所以我們將歐洲作為一個整體進行了建模，我們正在盡可能地將歐洲內部的國家納入其中可能會效仿美國的做法或行為，我們已經使用這些模型來製定我們的長期計劃。

Obviously, these are our best assumptions at present.

顯然，這些是我們目前最好的假設。

Only time will tell, in terms of where the market will actually go.

就市場實際走向而言，只有時間才能證明一切。

I think as well Josh, what I would add, if you look at the big picture, we have said that reliably, safely supplying biosimilars is not something that can be taken for granted, and if you look at the experience in Europe, you see several suppliers who struggle to fulfill the different tenders that they have won through time.

我也認為 Josh，我要補充的是，如果你著眼於大局，我們已經說過，可靠、安全地供應生物仿製藥並不是理所當然的事情，如果你看看歐洲的經驗，你會發現幾家供應商努力完成他們長期以來贏得的不同標書。

So even the barriers to entry, the challenges of safely supplying the marketplace in biosimilars has proven a challenge, and that's reflected in how we see marketplace competition evolving.

因此，即使是進入壁壘，安全供應生物仿製藥市場的挑戰也被證明是一個挑戰，這反映在我們如何看待市場競爭的演變中。

I suspect that as we get into more biologics going off patent and more complex molecules, we'll continue to see that be an issue.

我懷疑隨著我們進入更多的專利生物製劑和更複雜的分子，我們將繼續看到這是一個問題。

But generally, now with the benefit of more than a handful of competitors over more than a handful of years in a number of markets in Europe, the competition has been fairly predictable.

但總的來說，現在歐洲許多市場的競爭者在幾年多的時間裡受益匪淺，競爭已經相當可預測。

Both from a pricing and share standpoint.

從定價和份額的角度來看。

Got it.

知道了。

Thank you.

謝謝你。

Howard Liang, Leerink.

Howard Liang，Leerink。

Thanks very much.

非常感謝。

So, Neulasta, you had a very strong quarter, but also mentioned slight impact by competition.

所以，Neulasta，你有一個非常強勁的季度，但也提到了競爭的輕微影響。

Does that mean that there some inventory buildup?

這是否意味著有一些庫存增加？

Can you talk about in general whether there's some meaningful or significant inventory changes quarter-over-quarter for all the products?

您能否大致談談所有產品的季度環比是否存在一些有意義或顯著的庫存變化？

So for Neulasta there was a slight decline in inventory, in fact, in the quarter.

因此，對於 Neulasta，事實上，該季度的庫存略有下降。

As you know, Neulasta is clearly aligned to the number of myelosuppressive chemo regimens that take place in a quarter.

如您所知，Neulasta 顯然與一個季度內發生的骨髓抑制化療方案的數量保持一致。

We have not seen a dramatic increase or decrease of those regimens that take place, Howard, at the moment.

霍華德，目前我們還沒有看到這些治療方案的急劇增加或減少。

So I don't think there's much inventory flow, maybe $20 million, $30 million, that will flow into next quarter.

所以我認為下個季度不會有太多庫存流動，可能有 2000 萬美元、3000 萬美元。

But the usage has not been impacted by Granix, and we continue to get long-acting usage in all the accounts we have.

但使用並沒有受到 Granix 的影響，我們繼續在我們擁有的所有賬戶中獲得長效使用。

So Marvin, what I am thinking is so we can get back to preparing for our business review and have a more fulsome discussion tomorrow, why don't we just take two last questions?

所以馬文，我的想法是，我們可以回去準備我們的業務審查並在明天進行更全面的討論，我們為什麼不只回答最後兩個問題呢？

Geoffrey Porges, Bernstein.

伯恩斯坦的杰弗里波赫斯。

Thanks very much for letting me jump in with a question.

非常感謝您讓我提出一個問題。

Just wanted to follow-up with Tony and perhaps for David.

只是想跟進托尼，也許還有大衛。

Tony, could you break out price by US and ex-US?

托尼，你能按美國和美國以外的國家劃分價格嗎？

You gave us the net which was very helpful, but just give us the trends there?

你給了我們非常有幫助的網絡，但只是給我們那裡的趨勢？

And then, David, could you just talk about currency effects during the quarter and what we should be expecting for the next couple of quarters, presuming that things stay were they are?

然後，大衛，你能不能談談本季度的貨幣影響，以及我們對接下來幾個季度的預期，假設情況保持原樣？

Thanks.

謝謝。

Pricing total, price specific on the product?

總定價，產品具體價格？

Just in aggregate, for Europe -- or ex-US versus the US would be helpful.

總的來說，對於歐洲 - 或美國以外的美國將有所幫助。

So we deal only with price decreases outside the United States, so there are continuous challenges around price in Europe and in Japan, even though we don't have exclusivity yet.

所以我們只處理美國以外的價格下降，所以歐洲和日本的價格一直面臨挑戰，即使我們還沒有排他性。

But the price increases are predominately in the US, and not outside the US.

但價格上漲主要發生在美國，而不是美國以外。

Okay.

好的。

Thank you, and then currency, David?

謝謝，然後是貨幣，大衛？

Sure, on currency, well, first of all, as you would know, we have a fairly limited exposure right now as a Company to currency movements, given the profile of the business.

當然，在貨幣方面，首先，正如您所知，鑑於業務概況，我們現在作為一家公司對貨幣變動的風險敞口相當有限。

Secondly, the Company has a rolling hedge program, so we have quite an extensive portfolio against any of the traded currencies, where there is a forward market.

其次，公司有一個滾動對沖計劃，因此我們擁有相當廣泛的針對任何交易貨幣的投資組合，其中有遠期市場。

And as a consequence, you don't see any impact this quarter in our results due to foreign exchange movements, because they were offset by the hedge portfolio.

因此，由於外匯變動，您看不到本季度我們的業績受到任何影響，因為它們被對沖投資組合所抵消。

And then if you look into next quarter, it's around $0.02 of share negative, which is incorporated in the updated guidance.

然後，如果您查看下個季度，就會發現大約 0.02 美元的股票負值，這已包含在更新的指導中。

Terrific.

了不起。

Thanks very much.

非常感謝。

Chris Raymond, Robert Baird.

克里斯·雷蒙德，羅伯特·貝爾德。

Thanks a lot.

非常感謝。

Just a question back on Kyprolis.

只是一個關於 Kyprolis 的問題。

So noticing even if you back out inventory and the other effects, the unit growth, it looks like you had really the strongest sequential growth since right around the beginning of the launch.

因此請注意，即使您排除了庫存和其他影響，即單位增長，看起來您確實擁有自發布之初以來最強勁的連續增長。

I know ASPIRE was just top lined, but just what do you ascribe that reacceleration to generally, if you could maybe give a little more color on that, that would be great?

我知道 ASPIRE 只是排在首位，但你一般將這種重新加速歸因於什麼，如果你能給它更多的顏色，那會很棒嗎？

Let me take a few minutes.

讓我花幾分鐘時間。

The quote unquote growth was about $16 million.

報價未報價的增長約為 1600 萬美元。

$10 million of that is US, and $6 million is outside the US.

其中 1000 萬美元來自美國，600 萬美元來自美國境外。

As you know, outside the US, we are getting some preapproval sales in Europe and in Turkey, and we have the product approved in both Israel and Argentina.

如您所知，在美國以外，我們在歐洲和土耳其獲得了一些預先批准的銷售，並且我們的產品在以色列和阿根廷都獲得了批准。

So $10 million growth in the US, and $6 million outside the US.

因此，美國增長了 1000 萬美元，美國以外增長了 600 萬美元。

The $10 million in the US is about 13% growth, and as I said, predominately growing in third-line and fourth-line plus.

美國的 1000 萬美元增長了約 13%，正如我所說，主要增長在三線和四線以上。

Thanks for that, Tony.

謝謝你，托尼。

I also want to thank all of you for your participation in our call this afternoon, and look forward to seeing you tomorrow morning.

我還要感謝大家今天下午參加我們的電話會議，並期待明天早上與您見面。

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

女士們，先生們，今天的安進公司第三季度財報電話會議到此結束。

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。