美國安進 (AMGN) 2013 Q3 法說會逐字稿

My name is Marvin and I will be your conference facilitator today for Amgen's third-quarter 2013 financial results conference call.

我叫 Marvin，今天我將擔任 Amgen 2013 年第三季度財務業績電話會議的會議主持人。

All lines have been placed on mute to prevent any background noise.

所有線路都已設為靜音以防止任何背景噪音。

There will be a question-and-answer session at the conclusion of the last speaker's prepared remarks.

在最後一位發言者準備好的發言結束時將有一個問答環節。

In order to ensure everyone has a chance to participate we would like to request that you limit yourself to asking one question during the Q&A session.

為了確保每個人都有機會參與，我們希望您在問答環節中限制自己只問一個問題。

(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'd like to welcome you to our conference call to review our third-quarter financial results.

歡迎您參加我們的電話會議，回顧我們第三季度的財務業績。

This sure has been a busy year.

這肯定是忙碌的一年。

It's also been a great year so far as we have made remarkable progress against our strategic priorities.

就我們在戰略重點方面取得的顯著進展而言，這也是偉大的一年。

I'm joined today by our Chairman and CEO Bob Bradway, who will provide a progress update on our accomplishments.

今天，我們的董事長兼首席執行官 Bob Bradway 加入了我的行列，他將提供有關我們成就的最新進展。

Following Bob, our CFO, John Peacock will review our financial results for the third quarter and provide an update on our guidance for the remainder of the year.

繼我們的首席財務官 Bob 之後，John Peacock 將審查我們第三季度的財務業績，並提供我們對今年剩餘時間的指導的最新情況。

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

然後，我們的商業運營主管 Tony Hooper 將討論我們本季度的產品性能以及我們看到的未來趨勢。

And finally, Sean Harper, our Head of R&D, will provide a brief pipeline update, and after Sean's comments we should have ample time for Q&A.

最後，我們的研發主管 Sean Harper 將提供一個簡短的管道更新，在 Sean 的評論之後，我們應該有足夠的時間進行問答。

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.

這些幻燈片已發佈在我們的網站上，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，在我們今天的介紹和討論過程中，我們可能會做出某些前瞻性陳述，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？

Thank you, Arvind.

謝謝你，阿文德。

We executed well through the third quarter and you can see that both in our financial and our strategic results for the quarter.

我們在第三季度表現良好，您可以在本季度的財務和戰略結果中看到這一點。

Financially, sales were up 11% and earnings per share were up 16%, and off the back of this performance we're raising our guidance for revenues and adjusted earnings per share for the full year.

在財務方面，銷售額增長了 11%，每股收益增長了 16%，在這一業績的支持下，我們提高了對全年收入和調整後每股收益的指導。

A number of important pieces came together for our strategy over the past few weeks and I want to just quickly summarize them for you.

在過去的幾周里，我們的戰略匯集了許多重要的部分，我想快速為您總結一下。

In Japan, our strategic alliance, which is known as the Amgen Astellas BioPharma KK, has now begun operations.

在日本，我們的戰略聯盟 Amgen Astellas BioPharma KK 現已開始運作。

And we're developing five innovative molecules through the alliance, the first of which we expect to launch in 2016.

我們正在通過該聯盟開發五種創新分子，我們預計將在 2016 年推出其中的第一款。

And then ultimately of course we expect to establish our own wholly owned subsidiary in Japan as early as 2020.

最後，我們當然希望最早在 2020 年在日本建立我們自己的全資子公司。

In China, our joint venture with Zhejiang Beta Pharma is now complete and we hope to launch Vectibix there together as early as 2015.

在中國，我們與 Zhejiang Beta Pharma 的合資企業現已完成，我們希望最早在 2015 年在那裡推出 Vectibix。

We also announced our plans to build research and translational capabilities in China at Shanghai Tech University, representing a step forward in our commitment to this market.

我們還宣布了在中國上海科技大學建立研究和轉化能力的計劃，這標誌著我們對這個市場的承諾向前邁進了一步。

Consistent with our stated strategy of building a presence in some 75 countries, we've achieved that and more following the repurchase of rights to Neulasta and Neupogen from Roche in markets outside the US and EU.

與我們在大約 75 個國家/地區開展業務的既定戰略一致，在美國和歐盟以外市場從羅氏公司回購 Neulasta 和 Neupogen 的權利後，我們已經實現了這一目標，而且取得了更多成就。

These markets account for about $200 million in Neupogen and Neulasta sales and will provide a platform for future product launches.

這些市場佔 Neupogen 和 Neulasta 銷售額約 2 億美元，並將為未來的產品發布提供平台。

And finally of course we completed the acquisition of Onyx at the beginning of the month.

當然，最後我們在月初完成了對 Onyx 的收購。

And though it's still early days the transition is progressing smoothly and we're excited about the prospect of adding value and driving growth in multiple myeloma with Kyprolis, which we think has significant opportunity in earlier lines of therapy and in markets around the world as a best-in-class proteasome inhibitor.

儘管現在仍處於早期階段，但過渡進展順利，我們對 Kyprolis 增加價值和推動多發性骨髓瘤增長的前景感到興奮，我們認為它在早期治療和全球市場中具有重要的機會一流的蛋白酶體抑製劑。

Oprozomib looks attractive as well as a potential oral proteasome inhibitor for maintenance therapy in multiple myeloma, and of course we expect Nexavar, Stivarga, Palbociclib to contribute to growth also.

Oprozomib 看起來很有吸引力，它也是一種潛在的口服蛋白酶體抑製劑，可用於多發性骨髓瘤的維持治療，當然我們預計 Nexavar、Stivarga、Palbociclib 也有助於增長。

While we were busy laying the ground work for long-term growth with our strategic moves during the quarter our internal efforts were also progressing well.

在我們忙於通過本季度的戰略舉措為長期增長奠定基礎的同時，我們的內部努力也進展順利。

In R&D with the addition of Kyprolis and ivabradine, the innovative medicine for heart failure we licensed from Servier in July, our pipeline now includes 10 late-stage innovative programs set to generate pivotal data over the next couple of years.

在研發中，加上 Kyprolis 和伊伐布雷定（我們於 7 月從施維雅獲得許可的治療心力衰竭的創新藥物），我們的管道現在包括 10 個後期創新項目，這些項目將在未來幾年產生關鍵數據。

Separately, our portfolio of six biosimilars continues to advance as well and we now have a pivotal trial under way for our second of these molecules, this one a biosimilar to Humira.

另外，我們的六種生物仿製藥產品組合也在繼續推進，我們現在正在對這些分子中的第二個進行關鍵試驗，這是修美樂的生物仿製藥。

Some of you have asked about the status of the patent infringement lawsuit we filed in the US versus Teva on their long acting Lipegfilgrastim product candidate.

你們中的一些人詢問了我們在美國針對 Teva 對其長效 Lipegfilgrastim 候選產品提起的專利侵權訴訟的狀態。

Teva has advised us that they have withdrawn their PLA for the product and the FDA has confirmed this withdrawal so we've agreed to dismiss our lawsuit on this product.

Teva 已通知我們，他們已撤回該產品的 PLA，並且 FDA 已確認撤回，因此我們同意駁回我們對該產品的訴訟。

Of course if circumstances change we can refile the lawsuit.

當然，如果情況發生變化，我們可以重新提起訴訟。

Before turning to John I want to thank my colleagues at Amgen and our new colleagues from Onyx for their efforts during this past quarter.

在轉向 John 之前，我想感謝我在 Amgen 的同事和我們來自 Onyx 的新同事在上個季度所做的努力。

All of our focus on patients is evident in the strong operational and strategic results we produced over the last three months.

我們在過去三個月中取得的強勁運營和戰略成果證明了我們對患者的所有關注。

John?

約翰？

Thanks, Bob.

謝謝，鮑勃。

This has been a busy quarter for us.

這對我們來說是一個繁忙的季度。

We've advanced several of our most important strategic priorities as Bob has outlined, but at the same time we've remained focused on our business and delivered a strong operating performance in the quarter.

正如鮑勃概述的那樣，我們已經推進了幾個最重要的戰略重點，但與此同時，我們仍然專注於我們的業務，並在本季度實現了強勁的經營業績。

Revenues advanced 10% compared to the third quarter of 2012 with product sales up 11%.

與 2012 年第三季度相比，收入增長 10%，產品銷售額增長 11%。

This included a $155 million Neupogen order from the US government.

這包括來自美國政府的價值 1.55 億美元的 Neupogen 訂單。

It also reflected continued momentum with Prolia, with Xgeva, Enbrel, and Neulasta as well as important contributions from Sensipar, NPlate, and Vectibix.

它還反映了 Prolia、Xgeva、Enbrel 和 Neulasta 的持續發展勢頭，以及 Sensipar、NPlate 和 Vectibix 的重要貢獻。

Operating expenses were up 10% on the quarter overall.

營業費用比本季度整體增長了 10%。

Over the course of the last 12 months, we've been enrolling multiple clinical trials, which will enable a data rich year in 2014 as several of these trials start to read out.

在過去的 12 個月裡，我們一直在招募多項臨床試驗，這將使 2014 年成為數據豐富的一年，因為其中幾項試驗開始宣讀。

At the end of the quarter, we had approximately 45,000 patients enrolled in our late-stage programs, compared to around 30,000 12 months ago, that's an increase of 50%.

在本季度末，我們有大約 45,000 名患者參加了我們的後期項目，與 12 個月前的大約 30,000 名相比，增加了 50%。

Research and development costs in the quarter were also impacted by a $50 million up front payment to Servier to the US rights to ivabradine.

本季度的研發成本也受到向 Servier 預付 5000 萬美元以獲得伊伐布雷定美國權利的影響。

SG&A costs included 12% increase in Enbrel profit share payments which amounted to $430 million.

SG&A 成本包括增加 12% 的 Enbrel 利潤分成支付，達到 4.3 億美元。

And as a reminder, the Enbrel profit share expires at the end of this month and is replaced by 12% royalty on sales leading to an anticipated net benefit of around $800 million in operating income in 2014 compared to 2013.

提醒一下，Enbrel 的利潤分成將於本月底到期，取而代之的是 12% 的銷售特許權使用費，預計與 2013 年相比，2014 年營業收入的淨收益約為 8 億美元。

Net income increased by 13%.

淨收入增長了 13%。

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

我們在本季度的稅率低於 2012 年，這得益於聯邦研發信貸以及費用和收入的地域組合的變化。

This was partially offset by higher other income and expense.

這部分被較高的其他收入和支出所抵消。

The third-quarter charge for other income and expenses broadly representative of the charge that you should expect to see in the fourth quarter and into 2014.

第三季度其他收入和支出的費用大致代表了您應該預期在第四季度和 2014 年看到的費用。

Adjusted earnings per share growth of 16% also benefited from a lower average share count.

調整後每股收益增長 16% 也得益於較低的平均股數。

Turning to cash flow and the balance sheet on Page 5, we generated $1.6 billion of free cash flow in the quarter and paid a dividend totaling $400 million.

轉向現金流和第 5 頁的資產負債表，我們在本季度產生了 16 億美元的自由現金流，並支付了總計 4 億美元的股息。

Our total cash and investments of $26.5 billion at the end of the quarter included a $3.1 billion bank loan to fund the Onyx acquisition, which was disbursed when the deal closed on October 1. The funding for the acquisition was completed with a further $5 billion bank loan received and disbursed on October 1. With this, total debt outstanding at the end of the fourth quarter is expected to be $32.2 billion.

本季度末，我們的現金和投資總額為 265 億美元，其中包括為 Onyx 收購提供資金的 31 億美元銀行貸款，這筆貸款已在 10 月 1 日交易完成時支付。收購資金是通過另外 50 億美元的銀行完成的10 月 1 日收到和支付的貸款。據此，第四季度末未償債務總額預計為 322 億美元。

And as a reminder, the $8.1 billion raised to fund the Onyx acquisition carries an interest rate linked to LIBOR, on a current rate this amounts to 1.3% pre-tax.

提醒一下，為收購 Onyx 籌集的 81 億美元的利率與 LIBOR 掛鉤，按目前的利率計算，這相當於 1.3% 的稅前利率。

Share repurchases year-to-date amount to $800 million at an average price of $85.

年初至今的股票回購總額為 8 億美元，平均價格為 85 美元。

And following the Onyx acquisition we don't expect any significant share repurchase activity in 2014 and 2015.

在收購 Onyx 之後，我們預計 2014 年和 2015 年不會出現任何重大的股票回購活動。

Turning to Page 6. We're raising our guidance for the full year and this includes the contribution of Onyx from October 1. We now expect revenues to be in the range of $18.3 billion to $18.5 billion and adjusted earnings per share to be between $7.35 and $7.45.

翻到第 6 頁。我們正在提高全年的指引，其中包括從 10 月 1 日起 Onyx 的貢獻。我們現在預計收入將在 183 億美元至 185 億美元之間，調整後的每股收益將在 7.35 美元之間和 7.45 美元。

Our guidance on tax and capital expenditures remains unchanged.

我們對稅收和資本支出的指導意見保持不變。

Tony?

托尼？

Thanks, John.

謝謝，約翰。

You'll find the summary of our global sales performance for quarter three on Slide number 7. I'm pleased to report we had a strong quarter three with product sales growing 11% year-over-year and 1% quarter-over-quarter.

您可以在第 7 張幻燈片上找到我們第三季度全球銷售業績的摘要。我很高興地報告我們第三季度表現強勁，產品銷售額同比增長 11%，環比增長 1% .

We also saw strong top line contributions from all our geographic regions.

我們還看到了來自我們所有地理區域的強大收入貢獻。

Our US business grew 12% year-over-year with wholesale inventory ending in the normal range.

我們的美國業務同比增長 12%，批發庫存處於正常範圍內。

Outside the US, sales grew 7% year-on-year or 9% excluding foreign exchange.

在美國以外的地區，銷售額同比增長 7%，不包括外彙在內的銷售額增長 9%。

I'd like to start the review with our portfolio beginning with Enbrel.

我想從我們的產品組合開始審查，從 Enbrel 開始。

Rheumatologists and dermatologists continue to recognize Enbrel with track record of efficacy, safety, and long-term experience.

風濕病學家和皮膚科醫生繼續認可 Enbrel 在療效、安全性和長期經驗方面的記錄。

We are committed to investing in Enbrel over the long term, given our prolonged exclusivity at the end of our profit share agreement with Pfizer at the end of this month.

鑑於我們在本月底與輝瑞（Pfizer）公司達成的利潤分成協議結束時，我們將長期享有獨家經營權，因此我們致力於長期投資 Enbrel。

Enbrel sales grew 7% year over year, primarily due to price.

Enbrel 銷售額同比增長 7%，主要原因是價格。

We remain focused on demonstrating the value and benefits of Enbrel to physicians, payers, and most importantly patients.

我們仍然專注於向醫生、付款人和最重要的患者展示 Enbrel 的價值和益處。

Our direct-to-consumer advertising continued to emphasize the benefits for using Enbrel.

我們的直接面向消費者的廣告繼續強調使用 Enbrel 的好處。

Enbrel consistently leads total brand awareness in the rheumatology segment and physicians continue to honor over 90% of Enbrel patient requests.

Enbrel 在風濕病領域的總體品牌知名度始終處於領先地位，醫生繼續滿足 90% 以上的 Enbrel 患者要求。

We remain the value share leader in both the rheumatology and dermatology segments and 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，並對 Enbrel 的潛在增長充滿信心。

Moving now to Neulasta and Neupogen.

現在搬到 Neulasta 和 Neupogen。

Please remember that Neulasta represents about 80% of the combined sales of these two products.

請記住，Neulasta 約佔這兩種產品總銷售額的 80%。

We continue to emphasize the addition of filgrastim to the first and every cycle of chemotherapy as the best way to reduce the risk of febrile neutropenia in appropriate patients.

我們繼續強調在第一個和每個化療週期中加入非格司亭是降低適當患者發熱性中性粒細胞減少症風險的最佳方法。

Year-over-year, global sales for Neulasta increased by 9%.

與去年同期相比，Neulasta 的全球銷售額增長了 9%。

This was mainly driven by price and a slight increase in unit demand.

這主要是受價格和單位需求略有增加的推動。

For Neupogen, sales grew 50% year-over-year, including the $155 million order from the US government.

Neupogen 的銷售額同比增長 50%，其中包括來自美國政府的 1.55 億美元訂單。

Epogen sales were flat year-over-year.

Epogen 銷售額同比持平。

Quarter-over-quarter sales declined slightly due to a favorable Medicaid rebate adjustment for quarter two.

由於第二季度有利的醫療補助退稅調整，環比銷售額略有下降。

Unit demand in the quarter was stable.

本季度單位需求穩定。

Aranesp sales were down 10% year-over-year.

Aranesp 銷售額同比下降 10%。

Quarter-over-quarter sales were negatively impacted by changes in estimates in both quarters, including the Medicaid rebate adjustment recorded in quarter two.

環比銷售額受到兩個季度估計變化的負面影響，包括第二季度記錄的醫療補助退稅調整。

We expect Aranesp sales in both the US and Europe to continue trending slightly downwards.

我們預計 Aranesp 在美國和歐洲的銷售額將繼續呈小幅下降趨勢。

Sensipar sales increased 7% year-over-year due to increases in overall unit demand driven by strong segment penetration.

Sensipar 的銷售額同比增長 7%，這是由於強勁的細分市場滲透推動了整體單位需求的增長。

NPlate and Vectibix sales in aggregate were higher by 19% year-over-year, due to increases in unit demand.

由於單位需求的增加，NPlate 和 Vectibix 的總銷售額同比增長 19%。

In Europe, we continue to pursue reimbursement with payers for the treatment of first and second line metastatic colorectal cancer.

在歐洲，我們繼續尋求支付方報銷一線和二線轉移性結直腸癌的治療費用。

And our European label now includes the new NRAS data, which allows more targeted treatment of patients based on their wild-type RAS status.

我們的歐洲標籤現在包括新的 NRAS 數據，這允許根據患者的野生型 RAS 狀態對患者進行更有針對性的治療。

Turning now to the Denosumab franchise.

現在轉向 Denosumab 特許經營權。

Prolia posted a 62% year-on-year growth.

Prolia 同比增長 62%。

We did see however some seasonal softness in the third quarter, something we've come to expect, but we continue to grow share in both the US and the rest of the world.

然而，我們確實看到第三季度出現一些季節性疲軟，這是我們已經預料到的，但我們在美國和世界其他地區的份額繼續增長。

We also continue to improve repeat injection rates in the US and our latest data shows over 60% of patients returning for their second injection.

我們還在美國繼續提高重複注射率，我們的最新數據顯示超過 60% 的患者返回進行第二次注射。

Earlier this month we launched Prolia in France, which is the largest PMO market in Europe.

本月早些時候，我們在法國推出了 Prolia，這是歐洲最大的 PMO 市場。

Xgeva global sales grew 5% quarter-over-quarter, and in the US, our value share grew by 6 percentage points in the quarter.

Xgeva 全球銷售額環比增長 5%，在美國，我們的價值份額在本季度增長了 6 個百分點。

On a unit basis our share grew by 2 percentage points while competing against numerous generic zoledronic acid competitors.

在單位基礎上，我們的份額增長了 2 個百分點，同時與眾多通用唑來膦酸競爭對手競爭。

We now hold 42% unit share in the segment.

我們現在持有該部門 42% 的單位份額。

Outside the US, Xgeva grew 12% quarter-over-quarter, driven by share gains.

在美國以外，Xgeva 環比增長 12%，這主要得益於股價上漲。

Recent launches in Europe continue their strong uptake.

最近在歐洲推出的產品繼續受到強烈歡迎。

In France, we've already achieved 50% segment value share since launching in quarter one.

在法國，自第一季度推出以來，我們已經實現了 50% 的細分市場價值份額。

Our commercial focus remains on 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 卓越的臨床表現。

Other products, which is comprised of our sales from our Brazilian and Turkish businesses, declined 13% year-on-year.

其他產品，包括我們來自巴西和土耳其業務的銷售額，同比下降 13%。

This was primarily due to Turkey, since this business is driven in part by government tenders where timing of awards tends to fluctuate.

這主要是由於土耳其，因為該業務部分是由政府招標推動的，而政府招標的時間往往會波動。

We expect sales to significantly rebound in quarter four.

我們預計第四季度銷售額將大幅反彈。

Let me now turn to our new and exciting business, Onyx Pharmaceuticals.

現在讓我談談我們令人興奮的新業務 Onyx Pharmaceuticals。

I'd like to start by thanking the entire Onyx team for their unwavering commitment during the acquisition period.

首先，我要感謝整個 Onyx 團隊在收購期間的堅定承諾。

They remained focused and grew their business 6% quarter-over-quarter.

他們保持專注，業務環比增長 6%。

Importantly, I'd note that their US execution drove a 10% increase in the number of Kyprolis accounts during quarter as the depth of prescribing continued to grow.

重要的是，我注意到，隨著處方深度的持續增長，他們在美國的執行使 Kyprolis 賬戶數量在本季度增加了 10%。

We are excited to continue building on this important growth platform in multiple myeloma with potential expansion into earlier lines of therapy as well as launching in countries outside the United States.

我們很高興能夠繼續在多發性骨髓瘤這一重要的增長平台上進行建設，並有可能擴展到更早的治療線，並在美國以外的國家推出。

In summary, I'm very pleased with the competitive strategies our team has developed and our execution against these strategies.

總之，我對我們團隊制定的競爭策略以及我們對這些策略的執行感到非常滿意。

We remain focused on serving patients and bringing them vital medicines.

我們仍然專注於為患者服務並為他們提供重要的藥物。

Our underlying business delivers another strong quarter and I believe we are well positioned to meet our full-year revenue growth objectives.

我們的基礎業務又帶來了一個強勁的季度，我相信我們已做好充分準備，可以實現全年收入增長目標。

Let me now pass it to Dr. Sean Harper.

現在讓我將它傳遞給 Sean Harper 博士。

Thanks, Tony.

謝謝，托尼。

We continue to forge ahead on our existing pipeline efforts and I'd like to take this opportunity to also welcome our colleagues at Onyx.

我們將繼續推進我們現有的管道工作，我想藉此機會也歡迎我們在 Onyx 的同事。

The team has done an outstanding job advancing innovative multiple myeloma therapies and we're very optimistic about the long-term potential of Kyprolis and Oprozomib.

該團隊在推進創新多發性骨髓瘤療法方面做得非常出色，我們對 Kyprolis 和 Oprozomib 的長期潛力非常樂觀。

We're looking forward to the new Kyprolis data next year, including the final analysis of the FOCUS study in relapsed refractory multiple myeloma.

我們期待著明年的新 Kyprolis 數據，包括對複發難治性多發性骨髓瘤的 FOCUS 研究的最終分析。

In addition, the independent data monitoring committee will review an interim analysis of the ASPIRE study in relapsed disease next year.

此外，獨立數據監測委員會將於明年審查 ASPIRE 復發性疾病研究的中期分析。

As many of you are aware, FOCUS is the registration enabling study for refractory relapsed multiple myeloma targeting the EU, and this virus, the confirmatory study for full US approval, as well as a registration-enabling study for relapsed patients in both the US and EU.

正如你們中的許多人所知，FOCUS 是針對歐盟的難治性複發多發性骨髓瘤的註冊授權研究，這種病毒是美國完全批准的確認研究，以及美國和美國復發患者的註冊授權研究歐盟。

We will also be presenting additional data on Oprozomib, an oral proteasome inhibitor, at this year's American Society of Hematology meeting.

我們還將在今年的美國血液學會會議上展示有關口服蛋白酶體抑製劑 Oprozomib 的更多數據。

We are doing everything we can to help maintain momentum on these programs and to bring to bear any resources we can to further enable their success.

我們正在竭盡全力幫助保持這些計劃的勢頭，並動用我們力所能及的一切資源來進一步推動它們取得成功。

The mission and cultures of the two companies seem remarkably well aligned and I'm excited to have them on our team.

兩家公司的使命和文化似乎非常一致，我很高興他們能加入我們的團隊。

The lipid lowering program intended to be the basis of registration for AMG 145 now called evolucumab is completely enrolled and we eagerly await the results in 1Q 2014.

旨在成為 AMG 145 註冊基礎的降脂計劃現在稱為 evolucumab 已完全註冊，我們熱切期待 2014 年第一季度的結果。

We plan to speak more about this program along with our other cardiovascular programs at an investor event at the American Heart Association meeting in November where we will be presenting one year data from over 1,100 subjects in our Phase II open label extension study.

我們計劃在 11 月美國心臟協會會議的投資者活動中更多地談論這個項目以及我們的其他心血管項目，我們將在我們的 II 期開放標籤擴展研究中展示來自 1,100 多個受試者的一年數據。

For trebananib, we continue to estimate the final overall survival analysis from the ongoing pivotal study in recurrent ovarian carcinoma to occur in the second half of 2014.

對於 trebananib，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。

We have decided to discontinue enrollment in our study of trebananib in combination with Doxil in the setting of recurrent ovarian carcinoma due to ongoing Doxil supply issues.

由於持續的 Doxil 供應問題，我們決定停止參加我們的 trebananib 聯合 Doxil 治療復發性卵巢癌的研究。

We've also determined that a much smaller study than initially planned can be utilized to adequately assess the effects of trebananib on progression-free survival in first line ovarian cancer.

我們還確定，可以利用一項比最初計劃的規模小得多的研究來充分評估 trebananib 對一線卵巢癌無進展生存期的影響。

In addition, the emerging therapeutic landscape in non-small cell lung cancer limits the potential utility of trebananib in the study so we're also discontinuing enrollment in this Phase II study.

此外，非小細胞肺癌的新興治療前景限制了 trebananib 在研究中的潛在效用，因此我們也停止了這項 II 期研究的招募。

There were no new safety findings related to these decisions.

沒有與這些決定相關的新安全發現。

Our psoriasis program for Brodalumab consists of three Phase III studies, one placebo-controlled and two head-to-head against ustekinumab, or Stelara.

我們的 Brodalumab 銀屑病項目包括三項 III 期研究，一項是安慰劑對照研究，兩項是針對優特克單抗或 Stelara 的頭對頭研究。

I'm pleased to report all these are now fully enrolled and we expect to see the data next year.

我很高興地報告所有這些現在都已完全註冊，我們預計明年會看到這些數據。

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

Velcalcetide 或 AMG 416 是我們正在研究的新型 IV 擬鈣劑，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 next year and we will be presenting Phase II data at the American Society of Nephrology meeting next month.

預計明年將獲得 III 期數據，我們將在下個月的美國腎髒病學會會議上公佈 II 期數據。

Just to close the loop with you on an outstanding Xgeva filing, after extensive discussions with EU regulators we've decided not to pursue further our requests for a bone metastasis free survival indication in castrate resistant prostate cancer in Europe.

在與歐盟監管機構進行廣泛討論後，我們決定不再進一步提出我們對歐洲去勢抵抗性前列腺癌的無骨轉移生存指徵的要求，以便與您就一份未完成的 Xgeva 申請達成共識。

Our biosimilars unit continues to make good progress, and as Bob mentioned, enrollment has commenced in our biosimilar Humira pivotal study in psoriasis.

我們的生物仿製藥部門繼續取得良好進展，正如 Bob 所提到的，我們的牛皮癬生物仿製藥 Humira 關鍵研究的註冊已經開始。

Finally, I'd just like to take a moment and acknowledge my colleagues in R&D who continue to innovate and execute at a very high level.

最後，我想花點時間感謝我的研發部門的同事們，他們不斷創新並以非常高的水平執行。

We've made great progress this year and as you can see from my last slide, eight of our late-stage programs will achieve significant milestones next year.

我們今年取得了很大進展，正如你從我上一張幻燈片中看到的那樣，我們的八個後期項目將在明年實現重要的里程碑。

We'll be very busy in 2014 but our organization is ready and we look forward to continuing our track record of delivering novel therapies for patients in need.

2014 年我們將非常忙碌，但我們的組織已做好準備，我們期待繼續我們為有需要的患者提供新療法的記錄。

Bob?

鮑勃？

Okay, thank you, Sean.

好的，謝謝你，肖恩。

Marvin, we're ready for questions if you'd remind our listeners of the procedure, we'll open up the line for questions.

馬文，如果你提醒我們的聽眾程序，我們已經準備好提問了，我們將開通提問熱線。

(Operator Instructions)

（操作員說明）

Our first question comes from the line of Robyn Karnauskas with Deutsche Bank.

我們的第一個問題來自德意志銀行的 Robyn Karnauskas。

Thanks for taking my question.

感謝您提出我的問題。

So I guess, I think big picture, it seems like your base business continues to be more stable than a lot of people on the street expected, and you're continuing to grow your pipeline, like you did a deal today going into emerging markets.

所以我想，從大局來看，你的基礎業務似乎繼續比街上很多人預期的更穩定，而且你正在繼續擴大你的管道，就像你今天做了一筆進入新興市場的交易.

I'm struggling with understanding the impacts the new businesses have on margins and what the real revenue opportunity is for global expansion.

我正在努力了解新業務對利潤率的影響以及全球擴張的真正收入機會是什麼。

So, I know you haven't given guidance but maybe in a general sense, can you help me think about when you think global expansion will contribute meaningfully?

所以，我知道你沒有給出指導，但也許在一般意義上，你能幫我想想你認為全球擴張何時會做出有意義的貢獻嗎？

And how do we think about book ends for margin impacts?

我們如何考慮對利潤率影響的賬簿？

And then lastly, when do you think it's appropriate to give guidance on these businesses, more detailed financial guidance?

最後，您認為什麼時候適合對這些業務提供指導，更詳細的財務指導？

Okay, thanks Robyn, there are a couple questions.

好的，謝謝 Robyn，有幾個問題。

Why don't we try and answer that in two parts.

為什麼我們不嘗試分兩部分回答這個問題。

First you're right.

首先你是對的。

We've continued to make progress in laying the ground work for our future growth.

我們在為未來的發展奠定基礎方面繼續取得進展。

We felt for some time that an important ingredient for our long-term success was international expansion.

一段時間以來，我們認為我們取得長期成功的一個重要因素是國際擴張。

And, in particular, a clear path forward in Japan, China, and the other key emerging markets.

尤其是日本、中國和其他主要新興市場的明確前進道路。

And we've made tangible progress as reflected in the items that we reviewed from this quarter.

我們已經取得了切實的進展，這反映在我們從本季度審查的項目中。

So we feel good about the presence that we created and the ability to leverage that presence for our innovative molecules when they're ready to be launched.

因此，我們對我們創造的存在感以及在我們的創新分子準備好推出時利用這種存在感的能力感到滿意。

As regard your question about margins and returns, why don't I ask Tony to share his thoughts?

關於你關於利潤和回報的問題，我為什麼不請託尼分享他的想法？

We're obviously not going to provide individual market guidance.

我們顯然不會提供個別市場指導。

And I think, Robin, the next opportunity for us to talk more generally about guidance will be in connection with our fourth-quarter results, which is scheduled for January of course of next year.

而且我認為，羅賓，我們下一次更廣泛地談論指導的機會將與我們的第四季度業績有關，該業績定於明年 1 月公佈。

Tony do you want to offer any general thoughts on how we're thinking about markets and the criteria for profitability that we're holding the teams accountable to?

托尼，你想就我們如何看待市場以及我們讓團隊負責的盈利標準提出任何一般性想法嗎？

So as we think about Amgen presence at the moment we do have a fairly decent presence already in the Middle East, North Africa, and Latin America.

因此，當我們考慮安進目前的存在時，我們確實已經在中東、北非和拉丁美洲擁有相當不錯的存在。

Our business in this part of the world is really well in excess of $500 million and growing rapidly double digit.

我們在世界這一地區的業務確實超過 5 億美元，並且以兩位數的速度快速增長。

The products we have in the portfolio also are highly sophisticated biotech-type products.

我們的產品組合中的產品也是高度複雜的生物技術類產品。

So pricing is pretty much in line with the type of product we bring to market.

所以定價與我們推向市場的產品類型非常相符。

So we're not competing in these markets in the mass part of the market, but clearly around high medical need, with prices that allow us margins that are fairly close to the type of business we run in Europe at the moment.

因此，我們並沒有在這些市場的大部分市場競爭，而是圍繞高醫療需求展開競爭，價格使我們的利潤率與我們目前在歐洲經營的業務類型相當接近。

Okay, let's go to the next question?

好，我們進入下一個問題？

Our next question comes from the line of Terence Flynn with Goldman Sachs.

我們的下一個問題來自特倫斯弗林與高盛的合作。

Hi, thanks for taking the questions.

您好，感謝您提出問題。

Was just wondering first if you can provide us on your thoughts on the Kyprolis development program.

首先想知道您是否可以向我們提供您對 Kyprolis 開發計劃的想法。

Now that the deal has closed particularly would be curious in your outlook for both FOCUS and ASPIRE.

現在交易已經完成，您對 FOCUS 和 ASPIRE 的前景特別好奇。

And then in the event that FOCUS does not have a positive read out, how comfortable are you that ASPIRE will be enough to secure a label there?

然後，如果 FOCUS 沒有正面讀出，您認為 ASPIRE 足以確保那裡的標籤有多舒服？

And then the second question I had was just can you remind us of your strategy for your Humira biosimilar if the trial you're running is designed to support worldwide filings, including the US?

然後我的第二個問題是，如果您正在進行的試驗旨在支持包括美國在內的全球申請，您能否提醒我們您的 Humira 生物仿製藥戰略？

Thanks.

謝謝。

Okay, Terence, a couple questions there.

好的，特倫斯，有幾個問題。

Let's try to answer those.

讓我們嘗試回答這些問題。

Sean, I suppose you might want to just share with Terence your thoughts about the global development plan at Onyx.

Sean，我想你可能只想和 Terence 分享你對 Onyx 全球發展計劃的看法。

Yes, I think that the FOCUS and ASPIRE trials will read out next year, FOCUS in its final form and ASPIRE will have an interim analysis reviewed by the data monitoring committee.

是的，我認為 FOCUS 和 ASPIRE 試驗將於明年宣讀，最終形式的 FOCUS 和 ASPIRE 將由數據監測委員會審查中期分析。

And if positive, we'll see it.

如果是肯定的，我們會看到它。

Otherwise we'll see the final analysis.

否則我們將看到最後的分析。

I think that in the case that -- FOCUS is really focused on a third plus line indication for Europe, and we feel that it's quite an independent thing from the goals of ASPIRE, which are to allow a relapsed population, or if you will, a second line population to have a registration path in both the US and EU.

我認為，在這種情況下——FOCUS 真正專注於歐洲的第三條線以上的指標，我們認為這與 ASPIRE 的目標完全獨立，即允許人口復發，或者如果你願意的話，二線人口在美國和歐盟都有註冊途徑。

And we're pretty confident that assuming the results are what we're hoping for, that that stands on its own from a regulatory perspective.

我們非常有信心假設結果是我們所希望的，從監管的角度來看，這是獨立的。

And Tony on Humira, do you want to answer Terence's question?

關於 Humira 的 Tony，你想回答 Terence 的問題嗎？

Sure.

當然。

Our biosimilar strategy is clearly a global strategy, we are working closely with the FDA to understand requirements, we understand what's required in Europe, and then we're working with other countries outside those two regions to try and understand where the pathway is going forward, but we think globally, on a consistent basis, yes.

我們的生物仿製藥戰略顯然是一項全球戰略，我們正在與 FDA 密切合作以了解要求，我們了解歐洲的要求，然後我們正在與這兩個地區以外的其他國家合作，試圖了解這條道路的前進方向，但我們在全球範圍內始終如一地思考，是的。

Okay Marvin, let's take the next question and maybe you can just remind the audience to limit themselves to one question, please, so we can get through everybody.

好的，馬文，讓我們開始下一個問題，也許你可以提醒聽眾將自己限制在一個問題上，這樣我們就可以通過每個人。

(Operator Instructions)

（操作員說明）

Our next question comes from the line of Eric Schmidt with Cowen and Company.

我們的下一個問題來自 Eric Schmidt 與 Cowen and Company 的對話。

Thanks.

謝謝。

Maybe just a quick one on Bob's comments around Teva and IP dispute around long acting GCSF.

也許只是關於 Bob 關於 Teva 的評論和關於長效 GCSF 的知識產權爭議的快速評論。

Can you remind us when your patent actually expires and whether Teva withdrew the PLA because of the patent, or for some other issue?

您能否提醒我們您的專利實際何時到期以及 Teva 是否因為專利或其他問題撤回了 PLA？

Eric, our IP on Pegfilgrastim extends through the end of 2015, and as I said in my remarks we understand that they've withdrawn the product from -- or withdrawn the file rather from the FDA, and that's the reason why we dropped our lawsuit.

Eric，我們在 Pegfilgrastim 上的知識產權一直延續到 2015 年底，正如我在評論中所說，我們知道他們已經從 FDA 撤回了產品，或者撤回了文件，這就是我們放棄訴訟的原因.

Do you know why, Bob?

你知道為什麼嗎，鮑勃？

You'd have to ask them that question.

你得問他們這個問題。

Thank you.

謝謝你。

Thanks.

謝謝。

Our next question comes from the line of Mark Schoenebaum with ISI Group.

我們的下一個問題來自 ISI Group 的 Mark Schoenebaum。

Hi guys.

嗨，大家好。

Thanks for taking the question.

感謝您提出問題。

I know that CMS has proposed cuts to reimbursement rates to dialysis providers.

我知道 CMS 已提議降低透析提供者的報銷率。

I think this came up on the 2Q call.

我認為這是在 2Q 電話會議上提出的。

I think at the time, we were in the comment period.

我想當時我們正處於評論期。

I was wondering if you could update us on what's going on there.

我想知道你是否可以向我們介紹那裡發生的事情。

And if you could help us all understand that issue and what impact it could have to models.

如果你能幫助我們所有人理解這個問題以及它可能對模型產生什麼影響。

And if you could just comment on the Neupogen government purchase?

如果你能對 Neupogen 政府的購買發表評論？

Should we think of that as one-time?

我們應該認為這是一次性的嗎？

Thank you.

謝謝你。

Tony?

托尼？

Let me talk about the bundle.

讓我談談捆綁。

The time to comment CMS has now expired and we have assumed CMS would make some type of ruling earlier in November.

評論 CMS 的時間現已到期，我們假設 CMS 會在 11 月初做出某種類型的裁決。

We're not quite sure how the government shutdown will impact that timing, but we're standing by to wait to hear what's going to happen.

我們不太確定政府關門將如何影響這個時間點，但我們正在等待聽到會發生什麼。

Now the decision could be to implement immediately, it could be to implement over a period of time, or to implement at a time in the future.

現在的決定可以是立即實施，也可以是分一段時間實施，也可以是以後再實施。

We don't know yet what the impact will be or how much the proposed reduction will in fact be, so we are just waiting for that at the moment.

我們還不知道會產生什麼影響，也不知道提議的削減實際上會有多少，所以我們現在只是在等待。

On Neupogen?

在 Neupogen 上？

Sure, the government order, Mark, I think at this point we can't predict whether there will be future orders from the government or not.

當然，政府命令，馬克，我認為目前我們無法預測未來是否會有政府命令。

I think we would notice that we've got a strong track record of being able to supply customers with safe, reliable, quality Neupogen, Neulasta product, and if the government wants to order more, we're prepared to supply it.

我想我們會注意到，我們在為客戶提供安全、可靠、優質的 Neupogen 和 Neulasta 產品方面擁有良好的記錄，如果政府想要訂購更多，我們準備提供。

But at this point I wouldn't want to speculate as to whether there will be future orders.

但在這一點上，我不想推測是否會有未來的訂單。

Thanks.

謝謝。

Our next question comes from the line of Michael Yee with RBC Capital Markets.

我們的下一個問題來自 RBC Capital Markets 的 Michael Yee。

Just to confirm one, the Pegfilgrastim application was withdrawn, but are we still expecting both a Neupogen-like and a non-peg Neulasta-like product to come from Teva soon and both under settlement?

只是為了確認一個，Pegfilgrastim 的申請被撤回了，但我們是否仍然期待 Teva 很快會推出類似 Neupogen 和非 peg Neulasta 的產品，並且都在結算中？

Maybe you could clarify if you expect both of those to come and how we should as investors be expecting your franchise to look once those do arrive to market.

也許你可以澄清一下你是否期望這兩者都會出現，以及我們作為投資者應該如何期望你的特許經營權在這些確實進入市場後看起來如何。

Okay couple things, Michael.

好吧，邁克爾。

Just to remind you, we expect that there will not be a Neupogen-like product on the market before mid-November.

提醒您，我們預計在 11 月中旬之前市場上不會有類似 Neupogen 的產品。

After that time, when our intellectual property expires on Neupogen, we would expect to see Teva launch a product, though I would note it won't be a biosimilar and it won't be a product that has the same label as Neupogen.

在那之後，當我們在 Neupogen 上的知識產權到期時，我們希望看到 Teva 推出一種產品，但我會注意到它不會是生物仿製藥，也不會是與 Neupogen 具有相同標籤的產品。

With respect to other long acting products, again so far as I'm aware, none are registered.

關於其他長效產品，據我所知，也沒有註冊。

And so, rather than speculate on what they might do, I think we'll wait and see what the regulatory reaction is to products that they have on file.

因此，與其猜測他們可能會做什麼，我認為我們將拭目以待，看看監管機構對他們備案的產品有何反應。

Okay.

好的。

Our next question comes from the line of Matt Roden with UBS.

我們的下一個問題來自瑞銀的馬特·羅登 (Matt Roden)。

Great, thanks for taking my question, as well.

太好了，也感謝您提出我的問題。

Sean, as you know I've been interested this ovarian program with trebananib, and just want to ask you about the Doxil shortage, which necessitated the closing of enrollment for Trinova-2.

肖恩，如你所知，我一直對使用 trebananib 的卵巢計劃感興趣，只想問你有關 Doxil 短缺的問題，這使得 Trinova-2 的註冊必須結束。

Just wondering if you could talk about whether or not that impacts your statistical power to hit PFS and OS, whether or not the second study is required for approval in the indication, and whether there are other implications we should consider here, thanks.

只是想知道您是否可以談談這是否會影響您達到 PFS 和 OS 的統計能力，第二項研究是否需要在適應症中獲得批准，以及我們是否應該在這裡考慮其他影響，謝謝。

Yes, Matt, I don't think the Doxil study was always a non-registration trial to just generate data in the setting of a very commonly used agent in ovarian cancer, and so there really are two problems.

是的，馬特，我不認為 Doxil 研究總是非註冊試驗，只是在卵巢癌中非常常用的藥物的背景下生成數據，因此確實存在兩個問題。

One is that it's not really a very commonly used agent in ovarian cancer anymore because it's so unreliable in its supply, and we can't get the drug.

一是它不再是治療卵巢癌的常用藥物，因為它的供應非常不可靠，而且我們也買不到這種藥。

This is the second time we've had to do this, and it's just very disruptive to not have supply for patients in a clinical trial setting.

這是我們第二次不得不這樣做，在臨床試驗環境中沒有為患者提供供應是非常具有破壞性的。

So, that should have no bearing at all on our ability to register the product, to assess OS in the existing independent study with the Paclitaxel background that we're waiting for some time next year, nor would it effect an ability to assess PFS in the first line study, which has always been the primary goal of the first line study.

因此，這對我們註冊產品的能力、在我們明年等待一段時間的紫杉醇背景的現有獨立研究中評估 OS 的能力完全沒有影響，也不會影響評估 PFS 的能力一線學習，這一直是一線學習的首要目標。

Great.

偉大的。

Thanks very much.

非常感謝。

Our next question comes from the line of Geoff Meacham with JPMorgan.

我們的下一個問題來自摩根大通的 Geoff Meacham。

Hi guys, thanks for taking the question.

大家好，謝謝你提出這個問題。

So Sean highlighted on Slide 9 all of the events, the data events for next year, but I wanted to ask Tony the commercial perspective on this.

所以 Sean 在幻燈片 9 上強調了所有事件，明年的數據事件，但我想問 Tony 對此的商業觀點。

Is there an ROI that you're looking for for the various Phase II or III assets that you have that are maturing?

您是否正在尋找您正在成熟的各種 II 期或 III 期資產的投資回報率？

I guess, said another way just given your top line, is there a threshold that these assets have to cross to really move the dial for you guys?

我想，換一種方式說給你的頂線，這些資產是否有一個門檻必須跨越才能真正為你們移動撥號盤？

Thanks.

謝謝。

Geoff, it's Bob.

傑夫，是鮑勃。

I may jump in there on the question you directed at Tony.

我可能會跳到你針對托尼的問題。

Our intention is to advance molecules for which we think we can exceed the cost of our capital.

我們的目的是推進我們認為我們可以超過我們的資本成本的分子。

So, when we look at our late and early stage programs, we want to have a clear view to what it's going to take to beat our cost of capital, and we think we're in good shape in that regard on the late stage molecules and we continue to watch that carefully on the mid stage and early stage programs.

因此，當我們審視我們的後期和早期項目時，我們希望清楚地了解如何才能擊敗我們的資本成本，並且我們認為我們在後期分子方面處於良好狀態我們將繼續在中期和早期階段的項目中仔細觀察。

Got you, okay.

明白了，好吧。

Our next question comes from the line of Ravi Mehrotra with Credit Suisse.

我們的下一個問題來自瑞士信貸的 Ravi Mehrotra。

Thanks for taking my question.

感謝您提出我的問題。

Another big picture question on your biosimilar assets.

關於您的生物仿製藥資產的另一個大問題。

When can we expect more news flow on the other five projects you've previously identified?

我們什麼時候可以期待關於您之前確定的其他五個項目的更多新聞流？

And given the changes in the biosimilar competitive environment since your business review day, do you view this opportunity as bigger than you guided to at that point?

考慮到自您的業務審查日以來生物仿製藥競爭環境的變化，您是否認為這個機會比您當時指導的更大？

Thank you.

謝謝你。

Ravi, why don't we answer this in two parts.

拉維，我們為什麼不分兩部分回答這個問題。

With respect to communications.

關於通信。

Again, as our biosimilar molecules enter pivotal trials, we'll plan to call them out on our quarterly calls as we did today, so we've done that for both the molecules that are now in pivotal trials.

同樣，隨著我們的生物仿製藥分子進入關鍵試驗，我們將計劃像今天一樣在季度電話會議上召集它們，因此我們已經為目前處於關鍵試驗中的兩種分子完成了這項工作。

And Tony if you want to talk more generally about the quality of the opportunity here jump in.

托尼，如果你想更籠統地談談機會的質量，請插進來。

So, as we monitor the six assets we've identified, all of them continue to grow globally, so the medium-term opportunity of playing in this market continues to be a lucrative market.

因此，當我們監控我們已經確定的六項資產時，它們都在全球範圍內繼續增長，因此在這個市場中發揮作用的中期機會仍然是一個有利可圖的市場。

We continue to believe that our ability to bring to market a high quality, reliable supply of product will be a unique benefit that Amgen has, so we continue to see it as an opportunity, yes.

我們仍然相信，我們將高質量、可靠的產品供應推向市場的能力將是安進公司擁有的獨特優勢，因此我們繼續將其視為一個機會，是的。

Thank you.

謝謝你。

Our next question comes from the line of Yaron Werber with Citi.

我們的下一個問題來自花旗的 Yaron Werber。

Thanks for taking my question.

感謝您提出我的問題。

I have also a little bit of a strategy question relating to cardiovascular franchise.

我還有一些與心血管特許經營相關的戰略問題。

If you don't mind, on 145 just give us a little bit of an update where you are on formulation.

如果您不介意，請在 145 上向我們提供一些您在配方方面的最新信息。

And are you thinking that the concentration will remain the same, but the device is going to change into an auto injector?

您是否認為濃度將保持不變，但該設備將變成自動注射器？

And then what is Ivabradine?

那麼伊伐布雷定是什麼？

Where does that fit in?

這適合哪裡？

And is it based on you're going to be looking for a CAD and chronic heart failure indication, or what's the strategy?

它是否基於您要尋找 CAD 和慢性心力衰竭適應症，或者策略是什麼？

Sounds like you're going to be using previous data to file, thank you.

聽起來你要使用以前的數據來歸檔，謝謝。

So regarding 145, as I've said many times before, this is a very competitive situation and we're not wanting to get into that level of specificity around how we're going to be presenting the agent.

因此，關於 145，正如我之前多次說過的那樣，這是一個非常有競爭力的情況，我們不想在我們將如何展示代理方面陷入那種程度的特殊性。

Suffice it to say that we think we're going to have good ways of delivering to patients the every two week and every four week presentations of the product.

只要說我們認為我們將有好的方法每兩周和每四個星期向患者展示一次產品就夠了。

Ivabradine is a really interesting molecule that is unique in its mechanism and has a really critical role in the management of heart failure outside the United States.

伊伐布雷定是一種非常有趣的分子，其機制獨特，在美國以外的心力衰竭管理中發揮著非常關鍵的作用。

We have data sets which are very robust supporting chronic heart failure where there's a large outcome study that was done not too long ago, put into the labels around the world.

我們有非常強大的數據集支持慢性心力衰竭，不久前進行了一項大型結果研究，並在世界各地貼上了標籤。

European heart failure guidelines include the use of Ivabradine in patients who can't be adequately rate controlled with beta blockers.

歐洲心力衰竭指南包括在不能用 β 受體阻滯劑充分控制心率的患者中使用伊伐布雷定。

So our desire is to see the agent registered ultimately in both of these indications, in congestive heart failure, as well as in patients with coronary artery disease and stable angina.

因此，我們希望看到該藥物最終在這兩種適應症、充血性心力衰竭以及冠狀動脈疾病和穩定型心絞痛患者中得到證實。

There is also a large outcomes trial within patients with coronary artery disease, approximately 20,000 patients that's going to read out next year, which should be potentially quite supportive to the use of the agent in the angina indication, so that's --

還有一項針對冠狀動脈疾病患者的大型結果試驗，明年將對大約 20,000 名患者進行宣讀，這可能會非常支持在心絞痛適應症中使用該藥物，所以——

Tony did you want to add?

托尼你想補充嗎？

Yes, so as we think about Amgen launching 145, which is one of our largest exciting opportunities we have, that would have been the first time Amgen competes in the cardiovascular field.

是的，所以當我們考慮安進推出 145 時，這是我們擁有的最大的激動人心的機會之一，這將是安進第一次在心血管領域競爭。

And therefore, Ivabradine, which as Sean is saying, being a unique opportunity, a unique mode of action in an area of high unmet medical need will allow us prior to the 145 launch to build competency, skills, in our organization, both a relationship with a cardiology group, make sure we understand the hospital interaction with the P&T committees, discharge protocols, all of which will play in line with the launch of 145.

因此，正如 Sean 所說，伊伐布雷定是一個獨特的機會，在醫療需求高度未滿足的領域中的獨特行動模式將使我們能夠在 145 發布之前在我們的組織中建立能力、技能，這既是一種關係與心髒病學小組一起，確保我們了解醫院與 P&T 委員會的互動、出院協議，所有這些都將與 145 的發布保持一致。

So really setting us up, getting us the experience at the same time, driving a rather exceptional product in a large unmet medical need.

因此，真正設置我們，同時讓我們獲得經驗，在大量未滿足的醫療需求中推出相當出色的產品。

Our next question comes from the line of Rachel McMinn with Bank of America Merrill Lynch.

我們的下一個問題來自美銀美林的 Rachel McMinn。

Question, I wanted to go back to Kyprolis.

問題，我想回到 Kyprolis。

I was hoping Sean, you might be a little bit more granular on your development plans on two fronts.

我希望肖恩，你可能會在兩個方面對你的發展計劃更加細化。

One, with the head-to-head studies it seems like for Endeavor and Clarion they are going to be important for front line approval, but also potentially for EU reimbursement given the cost concerns with Revlimid and Kyprolis.

第一，通過頭對頭的研究，對於 Endeavor 和 Clarion 來說，它們似乎對一線批准很重要，但考慮到 Revlimid 和 Kyprolis 的成本問題，它們也可能對歐盟報銷產生影響。

I guess my view is that these studies are fairly risky.

我想我的觀點是這些研究相當冒險。

Do you plan to make any changes to the design of these studies or add additional supplemental studies?

您是否計劃對這些研究的設計進行任何更改或添加額外的補充研究？

And then just on the cardiac pulmonary safety profile given the recent events with [area viclucic], I'm just wondering what your comfort level is on the safety profile?

然後就心肺安全概況考慮到最近發生的 [area viclucic] 事件，我只是想知道您對安全概況的舒適程度如何？

How confident are you, based on the data that you have today, that there's not going to be a safety imbalance that stops either of those studies early, thanks.

根據您今天擁有的數據，您有多大信心不會因安全失衡而提前停止這兩項研究，謝謝。

Sean?

肖恩？

Well first, I'd say that generally, as we looked at the Onyx opportunity, we were very impressed with the development program, and I see the development program as being quite well thought out.

首先，我要說的是，一般來說，當我們看到 Onyx 機會時，我們對開發計劃印象深刻，我認為開發計劃經過深思熟慮。

Of course we'll work with our colleagues at Onyx and think about details of the way that statistical analysis plans are done and this sort of thing at a technical level for sure, there will be a process of looking together at things.

當然，我們將與我們在 Onyx 的同事合作，並考慮統計分析計劃的完成方式的細節以及技術層面上的這類事情，肯定會有一個共同審視事物的過程。

But I think that generally speaking we feel very good about the development program, which has been developed with a lot of input from the experts in the field from around the world and regulatory authorities, of course.

但我認為，總的來說，我們對開發計劃感覺非常好，當然，該開發計劃是在來自世界各地的該領域專家和監管機構的大量投入下制定的。

It's always possible that we would add studies.

我們總是有可能增加研究。

I wouldn't think that there's anything that glares out as a missing piece, but there are lots of opportunities to do additional studies with these molecules with both Kyprolis and Oprozomib and we'll just have to think about that in a big picture perspective in terms of return on investment and overall portfolio management.

我不認為有任何東西可以作為缺失的部分而顯得突出，但是有很多機會用 Kyprolis 和 Oprozomib 對這些分子進行額外的研究，我們只需要從大局的角度考慮這一點投資回報和整體投資組合管理方面。

Safety, I think, I can't give you any guarantees about safety.

安全，我想，我不能給你任何關於安全的保證。

I mean the data that we see to date with the agent is reassuring and appears that the benefit that's being derived from the use of the products in a setting exceeds the safety concerns.

我的意思是，我們迄今為止看到的與代理有關的數據令人放心，並且似乎在環境中使用產品所帶來的好處超過了安全問題。

There are, of course, especially in oncology safety issues with virtually every therapeutic agent.

當然，幾乎每種治療藥物都存在特別是腫瘤學安全問題。

So, I still see a very strong benefit/risk profile here, and I think that the opportunity to let these studies play out and see what we learn from them is in front of us.

因此，我仍然在這裡看到非常強大的收益/風險狀況，而且我認為讓這些研究發揮作用並了解我們從中學到什麼的機會就在我們面前。

Okay, let's go to the next question, Marvin?

好的，讓我們轉到下一個問題，馬文？

Next question comes from the line of Geoffrey Porges with Sanford Bernstein.

下一個問題來自 Geoffrey Porges 與 Sanford Bernstein 的對話。

Thanks for taking the question.

感謝您提出問題。

I just had a question about the Onyx acquisition.

我剛剛有一個關於 Onyx 收購的問題。

If we look back at Onyx, they had about $200 million in operating expenses in Q2, and now you've had a chance to integrate the two organizations.

如果我們回顧一下 Onyx，他們在第二季度的運營費用約為 2 億美元，現在您有機會整合這兩個組織。

Could you give us a sense of what that operating expense might be looking like in Amgen's hands say a year from now once you've bedded everything in?

你能否讓我們了解安進手中的運營費用可能會是什麼樣子，比如從現在起一年後，一旦你把所有東西都放在裡面？

Thanks.

謝謝。

Sure, Geoff.

當然，傑夫。

I guess we're 21 days into this transition.

我想我們已經進入過渡期 21 天了。

What I'd observe is, as I said earlier the transition is moving smoothly and there clearly are going to be some opportunities for us to think about synergies, and as you'd expect we're down the road already in that regard with our colleagues at Onyx, but I'm not going to provide guidance at this point.

我觀察到的是，正如我之前所說的那樣，過渡正在順利進行，我們顯然會有一些機會來考慮協同作用，正如你所期望的那樣，我們已經在這方面走上了我們的道路Onyx 的同事們，但我現在不打算提供指導。

We'll have an opportunity to do that next year in January when we talk about the fourth quarter in the way that we typically do.

明年 1 月，我們將有機會以通常的方式談論第四季度。

But again I think the big picture, Geoff, is that we're three weeks into this, we feel good about what we've seen, I think feel good about the way in which we're working together and comfortable about the opportunity to help drive growth here and create value both from things that we can do to grow the brand and grow access, as well as things that we can do to provide cost synergies.

但我再次認為，傑夫，大局是我們已經進行了三個星期，我們對我們所看到的感覺很好，我認為對我們合作的方式感覺很好，並且對有機會幫助推動這裡的增長並從我們可以做的事情中創造價值來發展品牌和增加訪問權限，以及我們可以做的事情來提供成本協同效應。

Okay.

好的。

Our next question comes from the line of Chris Raymond with Robert W. Baird.

我們的下一個問題來自 Chris Raymond 和 Robert W. Baird 的台詞。

Another cardiovascular question for AMG 145.

AMG 145 的另一個心血管問題。

So we've picked up a lot more investor interest recently on Merck's upcoming IMPROVE-IT trial.

因此，我們最近對默克即將進行的 IMPROVE-IT 試驗引起了更多投資者的興趣。

And I know this is not your trial, not your product, but there's I think a fairly decent chance that there's going to be a read-through at least from investor standpoint, if that trial fails, and I know these mechanisms are very different.

我知道這不是你的試驗，不是你的產品，但我認為，如果試驗失敗，至少從投資者的角度來看，有相當大的機會進行通讀，而且我知道這些機制非常不同。

But can you maybe just give us a sense how should we be thinking about how the FDA might be thinking if indeed that trial doesn't show a long-term benefit, and what the implications are for what they might require for the entire PCSK9 class?

但是，您能否告訴我們，如果該試驗確實沒有顯示出長期益處，我們應該如何思考 FDA 可能會如何思考，以及這對整個 PCSK9 類可能需要的內容有何影響？ ？

Thanks.

謝謝。

Yes, I think it's obviously difficult to speak for the FDA in terms of how they might view LDL as a surrogate end point based on the results from one of dozens and dozens of studies that have been done that have shown that reducing LDL has had a salulatory effect on cardiovascular outcomes.

是的，我認為根據已經完成的幾十項研究中的一項研究的結果，就他們如何將低密度脂蛋白視為替代終點而言，我認為顯然很難代表 FDA 說話，這些研究表明降低低密度脂蛋白具有對心血管結果的有益作用。

I think it's just going to depend enormously on the actual interpretation -- detailed scientific interpretation of studies like IMPROVE-IT.

我認為這將在很大程度上取決於實際的解釋——對 IMPROVE-IT 等研究的詳細科學解釋。

I think those studies will be looked at carefully, any studies that come out over the next few years will be looked at carefully by regulators and the scientific community, but it's really down to the detailed assessment as to whether the results actually call into question whether LDL is a reasonable surrogate for cardiovascular outcomes while one waits for cardiovascular outcomes results to come from a trial which is well under way.

我認為這些研究將受到仔細審查，未來幾年出現的任何研究都將受到監管機構和科學界的仔細審查，但這實際上取決於詳細評估結果是否真的會引起質疑LDL 是心血管結果的合理替代指標，而人們正在等待心血管結果結果來自一項正在進行的試驗。

And it's just tough to speculate on that at this stage.

在現階段很難對此進行推測。

But I think that it's clear to me that LDL is looked at differently than other lipid parameters by regulators with respect to being the most robust of those.

但我認為我很清楚，監管機構對 LDL 的看法與其他脂質參數不同，因為它是其中最穩健的參數。

Thank you.

謝謝你。

Our next question comes from the line of Tony Butler with Barclays Capital.

我們的下一個問題來自巴克萊資本的托尼巴特勒。

I have a question, Tony you have commented about how well Enbrel has done not only in this quarter but in past quarters.

我有一個問題，托尼，你曾評論過 Enbrel 不僅在本季度而且在過去幾個季度的表現如何。

Yet in the last quarter you made a reference to some slowdown in the derm market, so I wondered if you could actually break apart how you're looking at the growth rates around each indication for Enbrel, would be very helpful.

然而在上個季度你提到了真皮市場的一些放緩，所以我想知道你是否真的可以分開你如何看待 Enbrel 的每個適應症的增長率，這將非常有幫助。

And if I could sneak in a second really quickly, it's again around 145.

如果我能很快地潛入一秒鐘，它又是 145 左右。

In your comments earlier, around Ivabradine, you made some references to the cardiologist, and I wondered if in fact your assumption was that 145 would not be used by the primary care physician?

在你之前的評論中，關於伊伐布雷定，你提到了心髒病專家，我想知道你的假設是否實際上是初級保健醫生不會使用 145？

Or did I simply misread that from your statements in chronic heart failure?

或者我只是從您關於慢性心力衰竭的陳述中誤讀了這一點？

Thanks very much.

非常感謝。

Tony, with regards to Enbrel, about two-thirds of our business is in rheumatology and about one-third in dermatology.

托尼，關於 Enbrel，我們大約三分之二的業務是風濕病學，大約三分之一是皮膚病學。

Net-net we've seen both these markets just slowdown a little bit in terms of growth, and still growing fairly healthily.

淨淨我們已經看到這兩個市場在增長方面都略有放緩，但仍在相當健康地增長。

In rheumatology, we clearly continue to hold market share.

在風濕病學方面，我們顯然繼續佔據市場份額。

In dermatology we've seen a slight decline in market share over the last couple of quarters or so.

在皮膚科，我們看到過去幾個季度左右的市場份額略有下降。

But we do believe that the product profile both in rheumatology from an efficacy and a safety perspective, as well as our profile in dermatology specifically here around safety will allow us to continue to maintain a fairly large market share as we go forward.

但我們確實相信，從功效和安全的角度來看，風濕病學的產品概況，以及我們在皮膚病學方面的概況，特別是在安全方面，將使我們能夠在前進的過程中繼續保持相當大的市場份額。

As with regards to 145, the assumption we are making is the initial launch of 145 will be more specifically on high risk patients, which will be treated by cardiologists.

關於 145，我們假設 145 的初始推出將更具體地針對高危患者，這些患者將由心髒病專家進行治療。

As always there will be a smattering of general practitioners who do a fair amount of cardiovascular work, but we don't see us going in the early stages to a large GP market, no.

與往常一樣，會有一小部分全科醫生做大量的心血管工作，但我們看不到我們在早期階段進入大型 GP 市場，不。

Thanks very much.

非常感謝。

Next question comes from the line of Eun Yang with Jefferies.

下一個問題來自 Eun Yang 與 Jefferies 的對話。

Thanks, a question on brodalumab.

謝謝，關於 brodalumab 的問題。

I'm assuming two Phase III trials are designed to show superiority with Stelara in psoriasis, and the fact that Novartis issued a superior efficacy over Enbrel with their IL17 antibody.

我假設兩項 III 期試驗旨在顯示 Stelara 在牛皮癬方面的優勢，以及 Novartis 的 IL17 抗體比 Enbrel 更有效的事實。

Why did you use Stelara as a compare versus Enbrel?

您為什麼使用 Stelara 與 Enbrel 進行比較？

Well I think the choice of Ustekinumab as the comparator for brodalumab was really a matter of just putting ourselves up against the molecule that we thought has the increasingly is becoming the agent of choice from an efficacy perspective in the disease.

好吧，我認為選擇 Ustekinumab 作為 brodalumab 的比較劑實際上只是讓我們自己對抗我們認為從疾病療效的角度來看越來越成為首選藥物的分子。

We wanted to set a high, as high a bar as we could really from the competition perspective, and so that was in part why we made the choice.

從競爭的角度來看，我們想設置一個盡可能高的標準，這也是我們做出選擇的部分原因。

We could have chosen other comparators but that was the choice that we made.

我們本可以選擇其他比較器，但這是我們做出的選擇。

Next question?

下一個問題？

Our next question comes from the line of Joel Sendek with Stifel Nicolaus.

我們的下一個問題來自 Joel Sendek 與 Stifel Nicolaus 的對話。

Thanks a lot.

非常感謝。

So, I had a question on the Kyprolis sales and obviously you seem pretty happy about the $65 million.

所以，我有一個關於 Kyprolis 銷售額的問題，顯然你似乎對 6500 萬美元很滿意。

But it looks to me pretty flat over the last couple quarters.

但在我看來，過去幾個季度的表現相當平淡。

I'm wondering if now that the drug is in your hands whether we should expect, or if there's any significant growth embedded in your guidance for the fourth quarter?

我想知道現在藥物是否掌握在您手中，我們是否應該期待，或者您對第四季度的指導是否有任何顯著增長？

Or do we need to wait for the new studies to come out next year?

還是我們需要等到明年新的研究出來？

Thanks.

謝謝。

Joel, it's Tony.

喬爾，是托尼。

So, let me just say a couple of things.

所以，讓我說幾件事。

The first leak of a potential acquisition started to come out in late June, so there's a fair amount of uncertainty amongst Onyx employees for a period of time.

潛在收購的第一次洩密於 6 月下旬開始出現，因此 Onyx 員工在一段時間內存在相當大的不確定性。

And as I said in my remarks earlier, I'm pretty impressed that in spite of this terrible disruption that happened in their lives, they maintained the business as well as they did, including third quarter is normally a fairly soft quarter even for oncology.

正如我在之前的發言中所說，儘管他們的生活發生了這種可怕的破壞，但他們仍然保持著業務的正常運轉，這給我留下了深刻的印象，包括第三季度通常是一個相當疲軟的季度，即使對於腫瘤學也是如此。

14 days after the close we had in the hands of every single field-based employee a letter of employment confirming employment.

交易結束後 14 天，我們在每一位現場員工手中都收到了一份確認就業的僱傭信。

We've looked at this team.

我們看過這支球隊。

This team has obviously been put together with a clear knowledge of where the multiple myeloma market is, where the treatment physicians are, and we've hired through the Onyx team a top class oncology sales organization and medical field organization.

這個團隊顯然是在清楚了解多發性骨髓瘤市場在哪裡、治療醫生在哪裡的情況下組建起來的，我們通過 Onyx 團隊聘請了一流的腫瘤銷售組織和醫療領域組織。

We are certainly hoping that with certainty now reigning in their lives that performance will improve over the fourth quarter.

我們當然希望，現在可以肯定地在他們的生活中佔據主導地位，他們的表現將在第四季度有所改善。

But clearly, as you look to the medium to long term, the next major expansion of the Kyprolis label will come with both the FOCUS and the ASPIRE data, yes.

但很明顯，從中長期來看，Kyprolis 標籤的下一次重大擴張將伴隨著 FOCUS 和 ASPIRE 數據，是的。

Okay thanks.

好的謝謝。

Our next question comes from the line of Howard Liang with Leerink Swann.

我們的下一個問題來自 Howard Liang 和 Leerink Swann 的對話。

Thanks very much.

非常感謝。

Regarding the changes in the trebananib program, can you comment on whether these represent in any way a deemphasis of this compound, specifically regarding focusing, the focus on front line study on PFS, are you still pursuing a regulatory filing in the US for front line?

關於 trebananib 計劃的變化，您能否評論一下這些是否以任何方式代表對該化合物的弱化，特別是關於聚焦，對 PFS 一線研究的關注，你們是否仍在為一線研究在美國尋求監管備案？

And then the second Trenova 1 study can help your outlook for a quick filing given the interim overall trend that you presented.

然後，第二項 Trenova 1 研究可以幫助您展望快速歸檔，因為您提供了臨時總體趨勢。

Yes, no I think we're still quite interested in trebananib's potential, and see it as an agent which could gain registration globally in both first line and recurring disease.

是的，不，我認為我們仍然對 trebananib 的潛力非常感興趣，並將其視為一種可以在全球一線和復發性疾病中獲得註冊的藥物。

So, in the first line, I think we've recognized that it's extremely difficult, as I'm sure you know to try and achieve an overall survival result in the first line, and our general thought is that if we can achieve an OS result in a significant line of therapy-like in the recurrent study that we're awaiting for OS data now, that that would be sufficient for the molecule to allow us to move forward with attempts to register in first and second line globally.

所以，在第一線，我想我們已經認識到這是非常困難的，因為我相信你知道要在第一線嘗試並實現總體生存結果，我們的總體想法是如果我們能夠實現操作系統在我們現在正在等待 OS 數據的周期性研究中產生了一系列重要的治療方法，這足以讓分子允許我們繼續嘗試在全球範圍內進行一線和二線註冊。

So that's really the strategy, and the change in the size of the first line study doesn't diminish in any way our ability to assess the progression-free survival there.

所以這就是真正的策略，一線研究規模的變化不會以任何方式削弱我們評估無進展生存期的能力。

Marvin I think we have exhausted a lot of topics here so why don't we take one last question.

Marvin 我想我們已經在這裡討論了很多話題，所以我們為什麼不回答最後一個問題。

Last question comes from the line of Gene Mack with Brean Capital.

最後一個問題來自 Gene Mack 與 Brean Capital 的合作。

Thank you so much for taking the question.

非常感謝你提出這個問題。

Just on Oprozomib and the strategy there.

就在 Oprozomib 和那裡的策略上。

Wondering if you guys can give us a sense of, just given how fast Millennium moved their oral compound 9708 into Phase III testing, I'm just wondering how soon do you think you might be able to get into a pivotal program with Oprozomib?

想知道你們是否可以告訴我們，鑑於 Millennium 將他們的口服化合物 9708 進入 III 期測試的速度有多快，我只是想知道你們認為你們多久可以進入 Oprozomib 的關鍵項目？

Is it too early to tell at this point?

現在下結論還為時過早嗎？

Or can you like Millennium go from Phase I to -- really they went from Phase I to Phase III?

或者你能喜歡千禧年從第一階段到——真的他們從第一階段到第三階段嗎？

Thanks.

謝謝。

Yes, I think it's probably just too early in the process for me to speculate about that right now.

是的，我認為現在推測這個過程可能還為時過早。

The agent is really at the threshold between Phase IB and II at the moment.

目前，代理確實處於階段 IB 和階段 II 之間的門檻。

And I'm sure there's an ability to be aggressive with the development of the molecule, but we also want to do it right.

而且我確信有能力積極開發分子，但我們也想做對。

And skipping phases of development isn't always the best idea.

跳過開發階段並不總是最好的主意。

So, we'll have to noodle through that and decide how we're going to proceed.

所以，我們必須仔細考慮一下並決定我們將如何進行。

Great.

偉大的。

Thank you Sean, so let me thank everybody for your participation in our call this afternoon.

謝謝肖恩，讓我感謝大家今天下午參加我們的電話會議。

As you sift through all of this information if you have any questions or any other comments, let's continue the dialogue.

當您篩選所有這些信息時，如果您有任何問題或任何其他意見，讓我們繼續對話。

I, together with the rest of my team will be around for the next several hours so feel free to call.

我和我的團隊其他成員將在接下來的幾個小時內待命，請隨時致電。

Thanks again.

再次感謝。

Thank you.

謝謝你。

Ladies and gentlemen thank you for joining us for Amgen's third-quarter 2013 financial results conference call.

女士們，先生們，感謝您參加安進 2013 年第三季度財務業績電話會議。

This concludes today's conference call.

今天的電話會議到此結束。

You may now disconnect.

您現在可以斷開連接。