美國安進 (AMGN) 2014 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • My name is Martin, and I will be your conference facilitator today for Amgen's First-Quarter Earnings conference call.

    我叫馬丁,今天我將擔任安進第一季度收益電話會議的會議主持人。

  • (Operator Instructions)

    (操作員說明)

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

    我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。

  • Arvind Sood - VP of IR

    Arvind Sood - VP of IR

  • Thank you, Martin.

    謝謝你,馬丁。

  • Good afternoon, everybody.

    大家下午好。

  • I would like to welcome you to our conference call to review our operating performance for the first quarter of this year.

    歡迎您參加我們的電話會議,回顧我們今年第一季度的經營業績。

  • Our performance gives us confidence that we are on track to deliver our full-year guidance.

    我們的表現讓我們相信我們正在按計劃提供全年指導。

  • In addition, consistent with our expectations that 2014 will be a data-rich year, we have already reported significant data on Evolocumab and T-VEC and expect Phase 3 data on four of the programs in the remainder of the year.

    此外,與我們對 2014 年將是數據豐富的一年的預期一致,我們已經報告了 Evolocumab 和 T-VEC 的重要數據,並預計今年剩餘時間將有四個項目的 3 期數據。

  • Our Chairman and CEO, Bob Bradway, will lead the call today.

    我們的董事長兼首席執行官 Bob Bradway 將主持今天的電話會議。

  • Bob will provide a brief review of our operational progress, followed by our interim CFO, Michael Kelly, who will review our Q1 results.

    Bob 將簡要回顧我們的運營進展,隨後我們的臨時首席財務官 Michael Kelly 將回顧我們的第一季度業績。

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

    在 Michael 之後,我們的全球商業運營主管 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。

  • Sean Harper, our Head of R&D, will then provide a brief update on the many late-stage opportunities that we have in our pipeline.

    我們的研發主管肖恩·哈珀 (Sean Harper) 隨後將簡要介紹我們管道中的許多後期機會。

  • After Sean's comments, we should have plenty of time for Q&A.

    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聲明;實際結果可能存在重大差異。

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

    所以,有了這個,我想把電話轉給鮑勃。

  • Bob?

    鮑勃?

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • Okay, thank you, Arvind.

    好的,謝謝你,阿文德。

  • With the first quarter of the year complete, we are confident that we are on track to deliver our financial and operational targets for the year.

    隨著今年第一季度的結束,我們有信心能夠按計劃實現今年的財務和運營目標。

  • Revenues were up 7% for the quarter, reflecting strong performance in Europe, and the benefit of our international expansion, including having acquired back from Roche our rights to Neulasta and NEUPOGEN in a number of emerging markets.

    本季度收入增長 7%,反映了歐洲的強勁表現,以及我們國際擴張的好處,包括從羅氏手中奪回了我們在許多新興市場對 Neulasta 和 NEUPOGEN 的權利。

  • In the US, while underlying demand for our products remains strong, sales were affected by inventory drawdowns across the portfolio, as Tony will describe shortly.

    在美國,雖然對我們產品的潛在需求依然強勁,但銷售受到整個產品組合庫存減少的影響,正如托尼將在稍後描述的那樣。

  • We maintained discipline around our capital and operating expenses in the quarter, as reflected in our 18% growth in operating income and strong cash flows on the quarter.

    我們在本季度的資本和運營支出方面保持了紀律,這反映在我們本季度的營業收入增長 18% 和強勁的現金流上。

  • Turning to our operational progress, we said in January that we expected 2014 to be a data-rich year for us.

    談到我們的運營進展,我們在 1 月份表示,我們預計 2014 年對我們來說將是數據豐富的一年。

  • And that's certainly is what it has been so far.

    這肯定是迄今為止的情況。

  • We are excited about Evolocumab and the data we generated in our pivotal programs, and we're moving rapidly now to file our regulatory submissions in the US and Europe this year.

    我們對 Evolocumab 和我們在關鍵項目中產生的數據感到興奮,我們現在正在迅速採取行動,今年在美國和歐洲提交我們的監管申請。

  • With both once-monthly and twice-monthly dosing options, we believe Evolocumab will be an important advance for patients with high levels of LDL cholesterol.

    憑藉每月一次和每月兩次的給藥選擇,我們相信 Evolocumab 將成為高 LDL 膽固醇患者的重要進步。

  • Onyx is performing well, and we're encouraged by the prospect of Kyprolis moving into earlier lines of therapy in multiple myeloma as further data become available later this year.

    Onyx 表現良好,我們對 Kyprolis 進入多發性骨髓瘤早期治療線的前景感到鼓舞,因為今年晚些時候將獲得更多數據。

  • We will be presenting data on T-VEC and blinatumomab at the upcoming ASCO meeting, and expect to report on four other Phase 3 programs during the course of the year.

    我們將在即將舉行的 ASCO 會議上展示 T-VEC 和 blinatumomab 的數據,並預計在年內報告其他四個 3 期項目。

  • In addition to our innovative portfolio, our biosimilar portfolio continues to progress favorably, with three of our six programs in pivotal trials currently.

    除了我們的創新產品組合外,我們的生物仿製藥產品組合繼續取得良好進展,目前我們六個項目中的三個項目正在進行關鍵試驗。

  • Heading into the balance of the year, we feel we are in a strong position to continue investing in the long-term growth of our business, while returning capital to shareholders in the form of increased dividend payments.

    進入今年的餘額,我們認為我們有能力繼續投資於我們業務的長期增長,同時以增加股息支付的形式向股東返還資本。

  • Before turning to Michael Kelly to walk us through the financials, let me thank my Amgen colleagues for their focus on delivering for our shareholders and the patients we serve.

    在轉向邁克爾凱利向我們介紹財務狀況之前,讓我感謝我的安進同事們專注於為我們的股東和我們服務的患者提供服務。

  • Michael?

    邁克爾?

  • Michael Kelly - Interim CFO

    Michael Kelly - Interim CFO

  • Thanks, Bob.

    謝謝,鮑勃。

  • Let me start by highlighting a few important points in our financial results.

    讓我首先強調我們財務業績中的幾個要點。

  • The underlying operating performance of the Company is tracking well against our plans for 2014; and accordingly, our revenue and EPS guidance remain intact.

    公司的基本經營業績與我們 2014 年的計劃保持一致;因此,我們的收入和每股收益指引保持不變。

  • Our full ownership of Enbrel in the US and Canada drove 18% operating income growth, as we were able to keep operating expenses flat even after absorbing the operations of Onyx.

    我們在美國和加拿大對 Enbrel 的完全所有權推動了 18% 的營業收入增長,因為即使在吸收了 Onyx 的業務後,我們也能夠保持營業費用持平。

  • Turning to page 4 of the presentation, you will see revenues grew by 7%, with 5% product sales growth, and $78 million of growth in other revenues, primarily due to our Nexavar and Stivarga partnerships.

    翻到演示文稿的第 4 頁,您會看到收入增長了 7%,產品銷售增長了 5%,其他收入增長了 7800 萬美元,這主要歸功於我們與 Nexavar 和 Stivarga 的合作。

  • Revenues declined on a quarter-over-quarter basis, which is consistent with our historical pattern for the first quarter.

    收入環比下降,這與我們第一季度的歷史模式一致。

  • However, the decline was a bit exacerbated this year by the wholesaler end user inventory dynamic at the end of 2013.

    然而,2013 年底批發商終端用戶庫存動態加劇了今年的下滑。

  • As I mentioned, operating income grew 18%, as operating expenses were flat year over year.

    正如我所提到的,營業收入增長了 18%,因為營業費用同比持平。

  • Within operating expenses, cost of sales margin improved by 0.5 points to 15.7%, driven by lower royalties.

    在運營費用中,在特許權使用費下降的推動下,銷售成本利潤率提高了 0.5 個百分點至 15.7%。

  • Research and development expenses increased by 17% year over year, with roughly half of that growth driven by the addition of Kyprolis and the balance due to other late-stage clinical programs.

    研發費用同比增長 17%,其中大約一半的增長是由 Kyprolis 的增加推動的,其餘部分是由其他後期臨床項目推動的。

  • SG&A expenses decreased by 14%, driven by significant reduction in Enbrel-related expenses.

    由於與 Enbrel 相關的費用大幅減少,SG&A 費用下降了 14%。

  • Other income and expenses were $160 million in the quarter, unfavorable to the first quarter of 2013 due to realized gains on our cash investment portfolio a year ago.

    本季度的其他收入和支出為 1.6 億美元,與 2013 年第一季度相比不利,原因是我們的現金投資組合在一年前實現了收益。

  • Despite 14% growth in pretax income, net income declined 4%; and earnings per share declined 5%, due to favorable tax items in the year-ago period.

    儘管稅前收入增長了 14%,但淨收入下降了 4%;由於去年同期的稅收優惠項目,每股收益下降了 5%。

  • Specifically, you will recall that last year we recognize the full amount of the 2012 federal R&D credit, and resolved federal audits, which enabled us to release provisions we held against potential tax liabilities.

    具體來說,你會記得去年我們承認了 2012 年聯邦研發信貸的全額,並解決了聯邦審計,這使我們能夠釋放我們對潛在稅收負債持有的準備金。

  • The tax rate in the first quarter this year was 15.4%, in line with our full-year tax rate guidance.

    今年第一季度的稅率為 15.4%,符合我們的全年稅率指引。

  • Finally, our share count increased 1% as we did not repurchase any shares over the last 12 months.

    最後,我們的股票數量增加了 1%,因為我們在過去 12 個月沒有回購任何股票。

  • Now turning next to cash flow and the balance sheet on page 5.

    現在轉到第 5 頁的現金流量和資產負債表。

  • We generated $1 billion in free cash flow in the first quarter of 2014, a year-over-year increase of 9%, ahead of revenue growth.

    2014 年第一季度,我們產生了 10 億美元的自由現金流,同比增長 9%,領先於收入增長。

  • We also increased our quarterly dividend per share by 30%, with payments totaling $0.5 billion in the quarter.

    我們還將季度每股股息提高了 30%,本季度支付總額為 5 億美元。

  • At the end of the quarter, we held $23.2 billion in cash, short-term, and restricted investments, up approximately $2 billion versus a year ago.

    在本季度末,我們持有 232 億美元的現金、短期和限制性投資,比一年前增加了約 20 億美元。

  • And our debt balance was $32 billion, reflecting the financing of the Onyx acquisition and our commitment to maintain a solid investment-grade credit rating.

    我們的債務餘額為 320 億美元,反映了 Onyx 收購的融資以及我們維持穩健投資級信用評級的承諾。

  • Lastly, turning to page 6, we are reconfirming our revenue guidance of $19.2 billion to $19.6 billion for the year, and our earnings guidance of $7.90 to $8.20 earnings per share.

    最後,翻到第 6 頁,我們再次確認我們今年的收入指引為 192 億美元至 196 億美元,以及每股收益為 7.90 美元至 8.20 美元的收益指引。

  • Our guidance on tax and capital expenditures remains unchanged as well.

    我們對稅收和資本支出的指導也保持不變。

  • On the tax rate, let me remind you that our guidance assumes that the R&D tax credit will be extended in 2014 and retroactively applied to the full year.

    關於稅率,讓我提醒您,我們的指南假設研發稅收抵免將在 2014 年延長並追溯適用於全年。

  • Let me now turn to Tony.

    現在讓我談談托尼。

  • Thank you.

    謝謝你。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • Thanks, Michael.

    謝謝,邁克爾。

  • Good afternoon, folks.

    下午好,伙計們。

  • You will find a summary of our global sales performance for the first quarter on slide 7.

    您可以在幻燈片 7 中找到我們第一季度全球銷售業績的摘要。

  • Product sales grew 5% year over year.

    產品銷售額同比增長 5%。

  • Our international business grew 9%, driven by its strong performance in Europe and the acquisition of filgrastim rights in several new and emerging markets.

    我們的國際業務增長了 9%,這得益於其在歐洲的強勁表現以及在幾個新興市場收購非格司亭的權利。

  • In the US, our business grew 4% year over year.

    在美國,我們的業務同比增長 4%。

  • As Michael said, quarter over quarter, global sales were down 9%, a trend which is consistent with the first quarter of last year.

    正如邁克爾所說,與上一季度相比,全球銷售額下降了 9%,這一趨勢與去年第一季度一致。

  • This was driven predominantly by US inventory drawdowns in the first quarter, following wholesaler and end customer inventory builds in the fourth quarter of last year.

    繼去年第四季度批發商和終端客戶庫存增加之後,這主要是由於第一季度美國庫存減少所致。

  • This affected nearly all products, but most notably, Enbrel.

    這幾乎影響了所有產品,但最顯著的是 Enbrel。

  • Total US wholesaler days on hand declined from 15 days at the end of 2013 to 13 days at the end of this quarter.

    美國批發商總庫存天數從 2013 年底的 15 天下降到本季度末的 13 天。

  • Our underlying business, however, as evidenced by the IMS in-market prescription data across our products, remains strong and in line with our expectations.

    然而,正如我們產品的 IMS 市場處方數據所證明的那樣,我們的基礎業務仍然強勁並符合我們的預期。

  • As Bob mentioned, we are confident that we will achieve our full-year revenue guidance.

    正如鮑勃所說,我們有信心實現全年收入目標。

  • Let's review our first-quarter product performance, beginning with Enbrel.

    讓我們回顧一下我們第一季度的產品表現,從 Enbrel 開始。

  • As I said, sales were impacted by wholesaler and end customer inventory builds at the end of 2013.

    正如我所說,2013 年底,銷售受到批發商和最終客戶庫存增加的影響。

  • The in-market IMS data shows underlying demand in rheumatology continues to be strong, while we have seen a slight decline in the dermatology segment.

    市場 IMS 數據顯示風濕病學的潛在需求繼續強勁,而我們看到皮膚病學領域略有下降。

  • Both of these segments, however, are growing at double digits.

    然而,這兩個細分市場都以兩位數的速度增長。

  • These demand trends for Enbrel have continued into second quarter.

    對 Enbrel 的這些需求趨勢一直持續到第二季度。

  • With the extended exclusivity of Enbrel and its established track record of long-term efficacy and safety, we will continue to invest in growing this important brand.

    憑藉 Enbrel 的獨家經營權及其長期有效性和安全性的良好記錄,我們將繼續投資發展這一重要品牌。

  • Turning now to Neulasta and NEUPOGEN.

    現在轉向 Neulasta 和 NEUPOGEN。

  • As a reminder, Neulasta represents over 75% of combined sales for these two products.

    提醒一下,Neulasta 佔這兩種產品總銷售額的 75% 以上。

  • As I noted earlier, this quarter includes sales in several new and emerging markets, where we acquired commercialization rights effective January 1. This is a further step in our strategy to expand globally.

    正如我之前提到的,本季度包括幾個新興市場的銷售額,我們在這些市場獲得了 1 月 1 日生效的商業化權利。這是我們全球擴張戰略的又一步。

  • On a year-over-year basis, Neulasta increased 5%, while NEUPOGEN declined 3%.

    與去年同期相比,Neulasta 增長了 5%,而 NEUPOGEN 下降了 3%。

  • We have seen nominal impact from recently launched short-acting competition in the US and long-acting competition in Europe.

    我們已經看到最近在美國發起的短效競爭和在歐洲發起的長效競爭產生了名義上的影響。

  • Nevertheless, we are taking this competition seriously and are responding accordingly to maintain our leadership position across both brands.

    儘管如此,我們正在認真對待這場比賽,並做出相應的回應,以保持我們在兩個品牌中的領先地位。

  • NEUPOGEN and Neulasta have a long history of safe, efficacious and reliable high-quality supply.

    NEUPOGEN 和 Neulasta 擁有安全、有效和可靠的高質量供應的悠久歷史。

  • Moving on to Aranesp.

    繼續 Aranesp。

  • Aranesp sales were down 2% year over year.

    Aranesp 銷售額同比下降 2%。

  • Looking forward, we continue to expect pricing pressure and competition in Europe.

    展望未來,我們繼續期待歐洲的定價壓力和競爭。

  • EPOGEN increased 6%.

    EPOGEN 增長了 6%。

  • We continue to monitor the hemoglobin levels and dose utilizations within the new bundled payment system.

    我們將繼續監測新捆綁支付系統中的血紅蛋白水平和劑量利用率。

  • Sensipar sales increased 2% year over year, driven by high unit demand and continued segment growth.

    在單位需求高和細分市場持續增長的推動下,Sensipar 銷售額同比增長 2%。

  • Next, Nplate and Vectibix.

    接下來是 Nplate 和 Vectibix。

  • Sales in aggregate were higher by 18% year over year, driven by strong unit demand.

    在強勁的單位需求推動下,總銷售額同比增長 18%。

  • For Vectibix, we continue to gain share in both Europe and the US.

    對於 Vectibix,我們繼續在歐洲和美國獲得份額。

  • In Europe, which represents over 50% of Vectibix sales, we continue to highlight the recent addition of first-line metastatic colorectal cancer to our label.

    在佔 Vectibix 銷售額超過 50% 的歐洲,我們繼續強調最近在我們的標籤中添加了一線轉移性結直腸癌。

  • And we are excited about the opportunity to serve these patients.

    我們很高興有機會為這些患者服務。

  • Now a few comments on our Denosumab franchise.

    現在對我們的 Denosumab 特許經營權發表一些評論。

  • Let me start with Prolia.

    讓我從 Prolia 開始。

  • Sales grew 38% year over year, driven by segment share gains in both the US and Europe.

    受美國和歐洲分部份額增長的推動,銷售額同比增長 38%。

  • We did see some seasonality that we have come to expect during the first quarter.

    我們確實看到了我們在第一季度預期的一些季節性。

  • The second quarter is off to a good start there.

    第二季度在那裡開了個好頭。

  • Our new direct-to-consumer campaign on television launched in January this year, led to a significant increase in unaided awareness, from 10% to 23%, as well as driving a four-fold increase in traffic to the Prolia.com website.

    今年 1 月,我們在電視上推出了新的直接面向消費者的活動,使獨立意識顯著增加,從 10% 增加到 23%,並推動 Prolia.com 網站的訪問量增加了四倍。

  • As announced earlier this month, we have also ended our collaboration with GSK in Europe and selected markets.

    正如本月早些時候宣布的那樣,我們還結束了與葛蘭素史克在歐洲和特定市場的合作。

  • We're in the process of transitioning all commercial activities.

    我們正在轉變所有商業活動。

  • We believe this will definitely enable us to leverage our experience of successfully launching Prolia in other parts of the world to drive greater growth in these markets.

    我們相信,這一定會讓我們能夠利用我們在世界其他地區成功推出 Prolia 的經驗來推動這些市場的更大增長。

  • Further, it will build experience and capacity in countries that will be important in accelerating future growth of our pipeline products.

    此外,它將在各國積累經驗和能力,這對於加速我們管道產品的未來增長非常重要。

  • XGEVA sales increased 25% year on year, driven by strong unit demand growth in both the US and European markets.

    在美國和歐洲市場單位需求強勁增長的推動下,XGEVA 銷售額同比增長 25%。

  • In the US, we continue to see share gains, despite generic Zometa competition.

    在美國,儘管有仿製藥 Zometa 的競爭,但我們繼續看到市場份額增長。

  • Outside the US, sales grew 76%, driven by the momentum of several successful launches in Europe during 2013.

    在美國以外的地區,銷售額增長了 76%,這得益於 2013 年在歐洲成功推出的多項產品。

  • Our focus remains on highlighting the superior clinical profile of XGEVA.

    我們的重點仍然是強調 XGEVA 的卓越臨床特徵。

  • Let me now turn to our newest product, Kyprolis.

    現在讓我談談我們的最新產品 Kyprolis。

  • Underlying demand trends remain consistent.

    基本需求趨勢保持一致。

  • Kyprolis continues to be the therapy of choice in third-line multiple myeloma in the US.

    Kyprolis 仍然是美國三線多發性骨髓瘤的首選療法。

  • We expect the next major revenue inflection point for Kyprolis will be when second-line data is included in the label.

    我們預計 Kyprolis 的下一個主要收入拐點將是標籤中包含二線數據時。

  • Lastly, the Other Products category, which includes our businesses in Turkey and Brazil, decreased 36% year over year.

    最後,其他產品類別,包括我們在土耳其和巴西的業務,同比下降 36%。

  • This was a $250 million business, with annual growth inclusive of negative foreign exchange impact, in mid-single digits.

    這是一項價值 2.5 億美元的業務,年增長率為中個位數,包括負面的外匯影響。

  • They are compact or tender-driven businesses, and therefore fluctuate quarter by quarter.

    它們是緊湊型或招標驅動型企業,因此每個季度都在波動。

  • In conclusion, we feel very confident in the strength of our underlying business.

    總之,我們對我們基礎業務的實力非常有信心。

  • With the first-quarter inventory drawdown behind us, we expect the second quarter to be in line with underlying demand.

    隨著第一季度庫存下降,我們預計第二季度將與潛在需求保持一致。

  • We remain confident that we will deliver on our full-year revenue guidance.

    我們仍然有信心實現我們的全年收入指引。

  • Let me now pass you to Sean.

    現在讓我把你傳給肖恩。

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • Thanks, Tony.

    謝謝,托尼。

  • Good afternoon.

    下午好。

  • 2014 is a data-rich year for us, and we're off to an exciting start.

    2014 年對我們來說是數據豐富的一年,我們迎來了一個激動人心的開端。

  • The reception by cardiologists and lipid experts to our pivotal Phase 2 Evolocumab studies at the American College of Cardiology was remarkable.

    心髒病專家和脂質專家對我們在美國心髒病學會進行的關鍵 2 期 Evolocumab 研究的接受非常出色。

  • The data themselves, coupled with the flexibility of every two week and monthly delivery options, were overwhelmingly viewed as positive.

    數據本身,加上每兩周和每月交付選項的靈活性,被壓倒性地認為是積極的。

  • In addition, positive results from our Phase 2 Evolocumab study in Japanese patients were recently presented at the Japan Circulation Society.

    此外,最近在日本循環學會上公佈了我們在日本患者中進行的 2 期 Evolocumab 研究的積極結果。

  • We are working diligently on our 2014 Evolocumab global filing packages, including the US submission.

    我們正在努力處理我們的 2014 年 Evolocumab 全球申請包,包括美國提交。

  • Further within our cardiovascular portfolio, FDA recently granted fast track status to Ivabradine in chronic heart failure.

    在我們的心血管產品組合中,FDA 最近授予伊伐布雷定治療慢性心力衰竭的快速通道地位。

  • And we are on track to make this submission in 2Q.

    我們有望在第二季度提交此文件。

  • Together these two innovative molecules, Evolocumab in dyslipidemia and Ivabradine in chronic heart failure, represent very meaningful potential value to patients with cardiovascular risk.

    這兩種創新分子,治療血脂異常的 Evolocumab 和治療慢性心力衰竭的伊伐布雷定,對有心血管風險的患者俱有非常有意義的潛在價值。

  • Turning to our oncology programs, we continue to look forward to new Kyprolis data, including a review by an independent data monitoring committee of an interim analysis of that ASPIRE study in relapsed multiple myeloma patients, and the final analysis of the FOCUS study, in relapsed refractory multiple myeloma.

    談到我們的腫瘤學項目,我們繼續期待新的 Kyprolis 數據,包括獨立數據監測委員會對複發多發性骨髓瘤患者的 ASPIRE 研究的中期分析的審查,以及 FOCUS 研究的最終分析,復發難治性多發性骨髓瘤。

  • In both of these event-driven studies, making precise estimates of the timing of the analyses is quite challenging.

    在這兩項事件驅動的研究中,對分析時間進行精確估計非常具有挑戰性。

  • Our best estimates are that one or both of these analyses could occur in Q2, although either of these analyses could instead occur in Q3.

    我們的最佳估計是,其中一項或兩項分析可能會在第二季度進行,儘管這些分析中的任何一項都可能在第三季度進行。

  • Our immuno-oncology programs continue to advance.

    我們的免疫腫瘤學項目繼續推進。

  • In 2013, we reported that our Phase 3 T-VEC in metastic melanoma met its durable response rate primary endpoint.

    2013 年,我們報告說我們在轉移性黑色素瘤中的 3 期 T-VEC 達到了其持久反應率主要終點。

  • We recently announced that with a P value of 0.51, we narrowly missed statistical significance on the secondary endpoint of overall survival, a pretty strong result given that this study was not statistically powered for survival.

    我們最近宣布,P 值為 0.51,我們勉強錯過了次要終點總生存期的統計顯著性,這是一個非常有力的結果,因為這項研究沒有統計學上的生存能力。

  • These data will be presented at ASCO.

    這些數據將在 ASCO 上公佈。

  • And we are currently reviewing the results with clinicians, regulators, and payers to determine the best course forward.

    我們目前正在與臨床醫生、監管機構和付款人一起審查結果,以確定最佳的前進方向。

  • In addition, we continue to believe that there is an opportunity for T-VEC to prime the immune system with checkpoint inhibitors.

    此外,我們仍然相信 T-VEC 有機會用檢查點抑製劑啟動免疫系統。

  • We are currently investigating T-VEC in combination with Ipilimumab, or Yervoy, in a Phase 1b/2 metastatic melanoma study.

    我們目前正在 1b/2 期轉移性黑色素瘤研究中研究 T-VEC 與 Ipilimumab 或 Yervoy 的結合。

  • The 1b portion will be presented at ASCO this year, and we are moving forward with our collaborative efforts with Merck on PD-1 antagonism and exploring other such collaborations.

    1b 部分將於今年在 ASCO 上展示,我們正在推進與默克公司在 PD-1 拮抗劑方面的合作,並探索其他此類合作。

  • We also recently reviewed the blinatumomab confirmatory Phase 2 results in relapsed refractory adult acute lymphoblastic leukemia.

    我們最近還審查了 blinatumomab 在復發難治性成人急性淋巴細胞白血病中的 2 期驗證性結果。

  • These data, which will also be presented at ASCO, continue to support a positive benefit-risk profile on these patients who have exhausted other therapeutic options.

    這些數據也將在 ASCO 上公佈,繼續支持這些已用盡其他治療選擇的患者的積極獲益-風險概況。

  • We are therefore initiating discussions with regulators on the potential for filing, based on these data.

    因此,我們正在根據這些數據與監管機構就備案的可能性展開討論。

  • Our psoriasis program for brodalumab, which we're developing with our partners at AstraZeneca MedImmune, consists of three Phase 3 studies, one placebo-controlled, and two head-to-head studies, comparing it to ustekinumab or Stelara.

    我們與 AstraZeneca MedImmune 的合作夥伴共同開發的 brodalumab 銀屑病項目包括三項 3 期研究、一項安慰劑對照研究和兩項頭對頭研究,將其與 ustekinumab 或 Stelara 進行比較。

  • We expect to see the data from the placebo-controlled study in the second quarter, with the other two studies reading out during the course of the year.

    我們希望在第二季度看到安慰劑對照研究的數據,其他兩項研究將在年內公佈。

  • We look forward to seeing you at this program which we hope will be not only remarkable efficacy, but also of paramount importance in psoriasis, a strong safety profile.

    我們期待著在這個計劃中見到您,我們希望它不僅具有顯著的療效,而且對銀屑病也至關重要,具有很強的安全性。

  • I'm also pleased to announce that we have initiated our Phase 3 program in psoriatic arthritis.

    我也很高興地宣布,我們已經啟動了銀屑病關節炎的第三階段計劃。

  • As you may recall, we have developed the only monoclonal antibody antagonist that the CGRP receptor in the clinic, AMG-334, which has demonstrated a potent ability to block this axis in humans.

    您可能還記得,我們在臨床上開發了唯一的單克隆抗體拮抗劑 CGRP 受體 AMG-334,它已證明在人體中具有阻斷該軸的強大能力。

  • We therefore moved directly into Phase 2b dose-ranging studies in the setting of migraine prophylaxis, with what we feel is the most optimal modality of receptor antagonism using a monoclonal antibody.

    因此,我們直接進入了偏頭痛預防的 2b 期劑量範圍研究,我們認為這是使用單克隆抗體進行受體拮抗作用的最佳方式。

  • We expect to see the results of our episodic migraine Phase 2b study by the end of this year, and the results of our recently-initiated chronic migraine Phase 2b dose-ranging to start next year.

    我們希望在今年年底看到我們的偶發性偏頭痛 2b 期研究的結果,以及我們最近啟動的慢性偏頭痛 2b 期劑量範圍研究的結果將於明年開始。

  • Finally, I'd like to take a moment to thank my colleagues in R&D and many other parts of the Company for helping to make possible the data flow we are experiencing this year to help patients in need.

    最後,我想花點時間感謝我在研發部門和公司許多其他部門的同事,感謝他們幫助我們實現了今年的數據流,以幫助有需要的患者。

  • Bob?

    鮑勃?

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • Thank you, Sean.

    謝謝你,肖恩。

  • Martin, why don't we open up the call to questions.

    馬丁,我們為什麼不打開問題電話呢?

  • And would you please remind our listeners of the process for the Q&A?

    您能否提醒我們的聽眾注意問答過程?

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Matt Roden, UBS.

    馬特·羅登,瑞銀。

  • Matt Roden - Analyst

    Matt Roden - Analyst

  • At ACC, it sounded like you weren't quite sure if you would be able to file Evolocumab in the US this year, but now you're talking about global filings in 2014.

    在 ACC,聽起來您不太確定今年是否能夠在美國提交 Evolocumab,但現在您談論的是 2014 年的全球申請。

  • So the question is, what has changed?

    那麼問題來了,改變了什麼?

  • Is that based off the FDA interaction, and how confident are you that you could get that done this year?

    這是基於 FDA 的互動嗎?您對今年能完成這項工作有多大信心?

  • Related, now that you have the data, how do think this product is going to be used, how is outcomes data?

    相關的,既然你有了數據,你認為這個產品將如何使用,結果數據如何?

  • What are the docs telling you?

    文檔告訴你什麼?

  • Thanks.

    謝謝。

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • Thanks, Matt, those are good questions.

    謝謝,馬特,這些都是很好的問題。

  • Sean, why don't you?

    肖恩,你為什麼不呢?

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • First part.

    第一部分。

  • I think this is clearly an evolving situation, which we assess on an ongoing basis, our interactions with regulators, as well as where the program stands, with respect to the accumulation of the weight of evidence required for a file, and all around, at this point, we have a good degree of confidence in our ability to file this year, including in the United States.

    我認為這顯然是一個不斷變化的情況,我們會持續評估這種情況,我們與監管機構的互動,以及該計劃所處的位置,關於文件所需證據權重的積累,以及周圍的一切,在在這一點上,我們對我們今年的備案能力,包括在美國,有很大的信心。

  • That is why we are making that statement.

    這就是我們發表該聲明的原因。

  • Tony, would you want to --?

    托尼,你想——?

  • From a medical perspective, it is clear to me that there are individuals who have a high cardiovascular risk residual, despite the use of existing therapies, particularly statins.

    從醫學的角度來看,我很清楚,儘管使用了現有的療法,尤其是他汀類藥物,但仍有一些人的心血管殘留風險很高。

  • Either because, despite full dose intensive statin therapy, they still have a modifiable risk factor in elevated LDL, or they are unable to be subjected to an intensive, or even moderate intensity statin regimen.

    要么是因為,儘管全劑量強化他汀類藥物治療,他們仍然有 LDL 升高的可改變危險因素,或者他們無法接受強化甚至中等強度他汀類藥物治療方案。

  • And it is clear to me that those patients are viewed by the physicians that I talked to, as patients who would be appropriate for a therapy like Evolocumab, even prior to the availability of outcomes data.

    我很清楚,與我交談過的醫生將這些患者視為適合 Evolocumab 等療法的患者,甚至在獲得結果數據之前也是如此。

  • So from a pure medical doctor to doctor interaction, that is the sense I get, there is a real patient population out there in need.

    因此,從純粹的醫生到醫生的互動,這就是我的感覺,那裡有真正需要幫助的患者群體。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • This is Tony.

    這是托尼。

  • The only thing I would add to what Sean just said, is that we have physicians talking about patients in three buckets.

    對於肖恩剛才所說的,我唯一要補充的是,我們有醫生在三桶中談論患者。

  • Obviously DFS patients are the unique subpopulation, and then, secondly, the high-risk patients.

    顯然 DFS 患者是獨特的亞群,其次是高危患者。

  • And the high-risk patients are those that either can't take a statin, or can no longer tolerate a statin, or those who are on a statin, but not yet at the goal level.

    高危患者是那些不能服用他汀類藥物,或者不能再耐受他汀類藥物,或者服用他汀類藥物但尚未達到目標水平的患者。

  • So those continue to be the [nearest] physicians see, this drug will bring the growth that we'll value.

    所以那些仍然是 [最近的] 醫生看到的,這種藥物將帶來我們重視的增長。

  • Truly, again, all-around high risk cardiovascular patients.

    真的,再一次,全方位的高危心血管患者。

  • Operator

    Operator

  • Terence Flynn, Goldman Sachs.

    特倫斯弗林,高盛。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Just two quick ones for me.

    對我來說只有兩個快速的。

  • First on Enbrel, Tony, I was wondering if you could quantify the inventory impact in the quarter for us?

    首先是 Enbrel,托尼,我想知道你是否可以為我們量化本季度的庫存影響?

  • And then on the PCSK9 outcomes trial, Sean, I was wondering if you can give us any sense of enrollment at this point, and then any insight on powering of the interim and final analyses?

    然後關於 PCSK9 結果試驗,肖恩,我想知道你是否可以在這一點上給我們任何參與的感覺,然後對中期和最終分析的動力有任何見解?

  • Thank you.

    謝謝你。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • Let me take Enbrel first, then.

    那我先吃恩布雷吧。

  • As you look at our data, it is clear that our fourth quarter is always slightly larger than the first quarter, and during the fourth quarter of last year, we did have some strange snowstorms in the East Coast, which resulted in about $120 million of product that moved from one year to another.

    當你看我們的數據時,很明顯我們的第四季度總是比第一季度略大,去年第四季度,我們在東海岸確實遇到了一些奇怪的暴風雪,導致大約 1.2 億美元的收入從一年轉移到另一年的產品。

  • When I look at the Enbrel data itself, what I was looking at this morning, in fact, was the NRxs from IMS.

    當我查看 Enbrel 數據本身時,我今天早上查看的實際上是來自 IMS 的 NRx。

  • And to me, the NRxs, which account for about 35% of total Rxs, are the true indicator of where the brand is going in the future.

    對我而言,佔總 Rx 約 35% 的 NRx 是品牌未來發展方向的真正指標。

  • On the rheumatology side, NRxs grew quarter on quarter 14%, and on the dermatology side, the NRxs grew 11% quarter on quarter.

    在風濕病學方面,NRxs 環比增長 14%,在皮膚病學方面,NRxs 環比增長 11%。

  • So just to give you an idea of the brand's large growing segment areas, with Enbrel itself getting new prescriptions as well.

    因此,只是為了讓您了解該品牌的大型增長細分領域,Enbrel 本身也獲得了新的處方。

  • Sean?

    肖恩?

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • We are quite pleased with the outcomes study enrollment.

    我們對結果研究招生非常滿意。

  • The study is very adequately powered to detect an effect size that would be clinically relevant to patients and to physicians, and this, of course, is a product that we think has great potential, so we spared no expense in the design of the trial.

    該研究非常有力地檢測出與患者和醫生臨床相關的效應量,當然,這是我們認為具有巨大潛力的產品,因此我們在設計試驗時不遺餘力。

  • There is no interim analysis, formal interim analysis of an outcomes study of this sort.

    沒有中期分析,沒有對此類結果研究的正式中期分析。

  • Operator

    Operator

  • Matthew Harrison, Morgan Stanley.

    摩根士丹利的馬修哈里森。

  • Matthew Harrison - Analyst

    Matthew Harrison - Analyst

  • I wanted to ask on the cost side, and you had talked a little bit about this on the call, but it looks like quarter over quarter, I'm sorry, year over year, you were up, you were down about $160 million, and you had suggested Enbrel was about $800 million for the year in terms of savings, so there's a $40 million delta.

    我想問一下成本方面的問題,你在電話中談了一點這個,但看起來季度環比,對不起,年復一年,你增加了,你減少了大約 1.6 億美元,你曾建議 Enbrel 在今年的儲蓄方面約為 8 億美元,因此有 4000 萬美元的增量。

  • I'm just wondering if that was all Onyx-related expenses, and if we should expect to see that amount of the Enbrel savings drop to the bottom line for the rest of the year?

    我只是想知道這是否是所有與 Onyx 相關的費用,我們是否應該期望看到 Enbrel 節省的金額在今年剩餘時間下降到底線?

  • Thanks.

    謝謝。

  • Michael Kelly - Interim CFO

    Michael Kelly - Interim CFO

  • Thank you Matthew.

    謝謝馬修。

  • I think you should assume that you would see this run rate of Enbrel drop to the bottom line offset by the Onyx expenses.

    我認為你應該假設你會看到 Enbrel 的這個運行率下降到由 Onyx 費用抵消的底線。

  • Matthew Harrison - Analyst

    Matthew Harrison - Analyst

  • Thank you.

    謝謝你。

  • Operator

    Operator

  • Eric Schmidt, Cowen and Company.

    埃里克施密特,考恩公司。

  • Eric Schmidt - Analyst

    Eric Schmidt - Analyst

  • Maybe for Tony on the GCSF business, I thought you pulled in about $200 million from the Roche acquisition, in terms of ex-US sales.

    也許對於 GCSF 業務的托尼來說,我認為你從羅氏收購中獲得了大約 2 億美元,就美國以外的銷售額而言。

  • It didn't look like we recognized nearly as much in Q1.

    看起來我們在第一季度的認識幾乎沒有那麼多。

  • Is that $200 million on an annual basis, $50 million on a quarterly basis.

    是每年 2 億美元,每季度 5000 萬美元。

  • Is this a tender business also, that's quite lumpy going forward?

    這也是一項招標業務嗎,未來會很坎坷嗎?

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • The acquisition looked like it was about a $200 million acquisition, obviously broken into quarters, the quarters tend to trend about 25% each.

    此次收購看起來像是一筆約 2 億美元的收購,顯然分為幾個季度,每個季度的趨勢往往約為 25%。

  • I think the first quarter was slightly lighter than that normal 25%, about 23%.

    我認為第一季度略低於正常的 25%,大約 23%。

  • Eric Schmidt - Analyst

    Eric Schmidt - Analyst

  • Okay so that is offset by some share losses, then?

    好的,那麼這可以被一些股票損失所抵消嗎?

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • As I said, we have Granix in the marketplace competing against Neupogen in the US, and we have long-acting competition in Europe.

    正如我所說,我們在市場上有 Granix 在美國與 Neupogen 競爭,我們在歐洲有長效競爭。

  • We haven't seen a huge impact from them, but of course, they have a lot of small impact, yes.

    我們還沒有看到他們的巨大影響,但當然,他們有很多小的影響,是的。

  • Eric Schmidt - Analyst

    Eric Schmidt - Analyst

  • Okay, thank you.

    好的謝謝你。

  • Operator

    Operator

  • Robyn Karnauskas, Deutsche Bank.

    Robyn Karnauskas,德意志銀行。

  • Robyn Karnauskas - Analyst

    Robyn Karnauskas - Analyst

  • Just trying to get -- drill down a little bit more on inventory versus what is going on with some of the products.

    只是試圖獲得 - 與某些產品的情況相比,更深入地了解庫存。

  • Are you seeing any impact from generic Neupogen, and are you seeing any impact from Otezla in the market on Enbrel?

    您是否看到仿製藥 Neupogen 的任何影響,您是否看到市場上 Otezla 對 Enbrel 的任何影響?

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • I will try to take those two points.

    我會嘗試抓住這兩點。

  • First, Tony, on Neupogen, again, if you want to address --

    首先,Tony,關於 Neupogen,如果你想解決——

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • As I said, with Neupogen, we have Granix on the market from Teva.

    正如我所說,有了 Neupogen,我們在市場上推出了 Teva 的 Granix。

  • They have been on the market since late last year.

    自去年年底以來,它們一直在市場上銷售。

  • We have seen a nominal impact from this product in the marketplace.

    我們已經看到該產品在市場上產生了名義上的影響。

  • As regard to Enbrel, we think all the excess inventory is now being worked out of the system, and as I said earlier, when I looked at the NRxs, those are showing double-digit growth as we go from quarter to quarter.

    關於 Enbrel,我們認為所有過剩庫存現在都在系統之外,正如我之前所說,當我查看 NRxs 時,隨著我們從一個季度到另一個季度,它們顯示出兩位數的增長。

  • Operator

    Operator

  • Josh Schimmer, Piper Jaffray.

    喬什·希默,派珀·杰弗瑞。

  • Josh Schimmer - Analyst

    Josh Schimmer - Analyst

  • A couple on the CGRP receptor antibody program for migraine.

    一對夫婦參加了針對偏頭痛的 CGRP 受體抗體計劃。

  • First, do you have any data from the deCODE data set, what the phenotype is for patients with CGRP or CGRP receptor mutations?

    首先,您是否有來自 deCODE 數據集的任何數據,CGRP 或 CGRP 受體突變患者的表型是什麼?

  • And second, who do you think is in the lead, amongst the CGRP antibodies, either receptor or how close to the lead are you?

    其次,在 CGRP 抗體中,您認為誰處於領先地位,無論是受體還是您與領先者的距離有多近?

  • Thanks.

    謝謝。

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • There are not, the sort of validation for this particular drug target is less from human genetics, and more from the work that has been done with the small molecule receptor antagonists, and now, reportedly, by a couple of the ligand sequestering antibodies, where we haven't seen detailed data, but there has been releases of positive results.

    沒有,這種特定藥物靶標的驗證較少來自人類遺傳學,更多來自小分子受體拮抗劑所做的工作,據報導,現在,通過一些配體螯合抗體,其中我們還沒有看到詳細的數據,但已經有積極的結果發布。

  • We have a reverse pharmacology level of human validation of the target.

    我們對目標進行了人類驗證的反向藥理學水平。

  • With respect to an antibody that blocks the receptor, we are clearly well in the lead.

    關於阻斷受體的抗體,我們顯然處於領先地位。

  • We have the only antibody-blocking receptor, because they are difficult, very difficult to engineer.

    我們有唯一的抗體阻斷受體,因為它們很難,很難設計。

  • In the case that just any antibody, I would say that I think we are in a very strong position right now, to potentially make it first to market with any of the antibodies, but that is a little hard to say, when you are still in Phase II.

    如果只是任何抗體,我想說我認為我們現在處於非常有利的地位,有可能首先將其與任何抗體一起推向市場,但這有點難說,當你還在在第二階段。

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • We are excited about this program, Josh, and excited about the early data, but as is the case with Evolocumab, we just want to keep our head down and keep executing against the program, and it looks exciting to us, but the competitive profile here is not completely transparent.

    Josh,我們對這個項目感到興奮,並對早期數據感到興奮,但就像 Evolocumab 的情況一樣,我們只想保持低調並繼續執行該項目,這對我們來說看起來很令人興奮,但競爭概況這裡不是完全透明的。

  • So we'll take the next question.

    那麼我們將回答下一個問題。

  • Operator

    Operator

  • Geoffrey Porges, Sanford Bernstein.

    杰弗里波赫斯,桑福德伯恩斯坦。

  • Geoffrey Porges - Analyst

    Geoffrey Porges - Analyst

  • Question for Bob, there is a lot going on in pharma and larger biotech in terms of asset swaps, relocations of assets.

    Bob 的問題是,在資產交換、資產遷移方面,製藥和大型生物技術領域正在發生很多事情。

  • I'm just wondering, from the outside, Amgen has two businesses, legacy products and growth products, and with all the restructuring going on, has Amgen considered any different structures or ownership of the assets that might enhance shareholder value?

    我只是想知道,從外部來看,Amgen 有兩項業務,遺留產品和增長產品,隨著所有重組的進行,Amgen 是否考慮過任何可能提高股東價值的不同結構或資產所有權?

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • Sure, Geoff.

    當然,傑夫。

  • As you would expect, we continually review things that we can do to drive shareholder value, and that is absolutely what we are focused on.

    正如您所期望的那樣,我們不斷審查我們可以做些什麼來推動股東價值,而這絕對是我們關注的重點。

  • We continue to believe that the strategy that we are following is the one that will enable us to drive most value for our shareholders, and that obviously includes executing against the innovative programs in our pipeline, and we have talked about a few high profile programs here on this call already, and continuing to advance our biosimilar programs, and we have six programs there that we think we're very competitively positioned for, and we began to launch in 2017.

    我們仍然相信,我們正在遵循的戰略將使我們能夠為股東創造最大價值,這顯然包括執行我們管道中的創新計劃,我們在這裡討論了一些備受矚目的計劃已經接到這個電話,並繼續推進我們的生物仿製藥項目,我們有六個項目,我們認為我們在這些項目中處於非常有競爭力的位置,我們在 2017 年開始啟動。

  • And of course international expansion we think is an opportunity for further growth for us, as well.

    當然,我們認為國際擴張也是我們進一步發展的機會。

  • We are focused on executing our strategy, but we obviously pay close attention to what is going on in our industry, and we will continue to look for opportunities that may offer us a chance to drive incremental value for our shareholders.

    我們專注於執行我們的戰略,但我們顯然密切關注我們行業正在發生的事情,我們將繼續尋找可能為我們提供機會為股東增加價值的機會。

  • Operator

    Operator

  • Yaron Werber, Citi.

    Yaron Werber,花旗銀行。

  • Yaron Werber - Analyst

    Yaron Werber - Analyst

  • Actually a little bit of a question on Kyprolis, and just trying to understand a little bit, what are you expecting from FOCUS and ASPIRE?

    實際上是關於 Kyprolis 的一個小問題,只是想稍微了解一下,您對 FOCUS 和 ASPIRE 有什麼期望?

  • Based on our analysis, ASPIRE may be unlikely to stop it at the next loop, but FOCUS has been taking quite a long time.

    根據我們的分析,ASPIRE 可能不太可能在下一個循環中停止它,但是 FOCUS 已經花費了相當長的時間。

  • So trying to get a sense, what should we read into your comments?

    因此,試著了解一下,我們應該從您的評論中讀出什麼?

  • Are you not expecting much in terms of acceleration until label expansion into second line, that is technically an ASPIRE program, not a FOCUS program?

    在標籤擴展到第二行之前,您是否對加速沒有太大期望,從技術上講,這是一個 ASPIRE 程序,而不是 FOCUS 程序?

  • And then, just a follow-up question on Oprozomib.

    然後,只是關於 Oprozomib 的後續問題。

  • You're really buying from the same sub-unit, my understanding, as Kyprolis, so your thoughts about potential heart failure, and also what are you seeing on the GI side, power-ability wise for the new formulation?

    你真的是從同一個子單位購買,我的理解,作為 Kyprolis,所以你對潛在心力衰竭的想法,以及你在 GI 方面看到了什麼,新配方的力量能力明智?

  • Thank you.

    謝謝你。

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • We may take these question in two parts, Yaron, I think there is a piece of the first question for Sean on the timetables and FOCUS and ASPIRE, and then Tony can talk about moving to other lines of patients and Sean --

    我們可以將這些問題分為兩部分,Yaron,我認為第一個問題是 Sean 的時間表以及 FOCUS 和 ASPIRE,然後 Tony 可以談談轉移到其他患者線,Sean --

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • I think it is always tempting when we see these trial event driven studies take longer than is expected through the original estimates that are made, to read into that, that there is something going on, that the therapeutic is having a bigger effect than was anticipated, or what have you.

    我認為,當我們看到這些試驗事件驅動的研究花費的時間比通過最初做出的估計所預期的時間更長時,我總是很想讀懂,有一些事情正在發生,治療的效果比預期的要大,或者你有什麼。

  • I have learned through experience, that is not a wise thing to do, generally.

    我從經驗中了解到,一般來說,這不是明智之舉。

  • Whatever is going on with the kinetics of collecting last events that are necessary to do these studies, which at this point, we are talking about single-digit number of events coming in per month, and it can be quite stochastic month to month, in both of the studies.

    無論收集進行這些研究所必需的最後事件的動力學是怎麼回事,在這一點上,我們談論的是每個月發生的個位數事件,而且每個月都可能是相當隨機的,在這兩項研究。

  • This is fairly typical as these studies accrue up to their final numbers.

    這是相當典型的,因為這些研究累積到他們的最終數字。

  • I don't think it is wise to try to read anything scientifically into that, around whether the agents are having the desired effect or not, in the trials.

    我認為嘗試從科學角度解讀任何東西是不明智的,圍繞這些藥物是否在試驗中產生了預期的效果。

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • Touch on Oprozomib, Sean.

    觸摸奧普佐米,肖恩。

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • On the Oprozomib, yes, with Oprozomib, we are still in early stages, and the product we know can have a GI toxicity at some doses, and so we are developing the product with that in mind, working on formulations, working on dosing schedule, to try and make sure we can deliver the greatest therapeutic benefit, without having an intolerable GI safety profile.

    關於 Oprozomib,是的,對於 Oprozomib,我們仍處於早期階段,我們知道該產品在某些劑量下可能具有 GI 毒性,因此我們在開發產品時考慮到這一點,研究配方,研究給藥方案,努力確保我們能夠提供最大的治療效果,而不會出現無法忍受的 GI 安全狀況。

  • So that is the name of the game when developing an oral version of this class of drug.

    所以這就是開發這類藥物的口服版本時的遊戲名稱。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • My comment about the next inflation has no hidden meaning at all.

    我對下一次通脹的評論沒有任何隱藏的意義。

  • We had always assumed that the ASPIRE data would give us the second-line indication in the US first, which would be followed by our launches outside the US, because we have to post-registration negotiate pricing.

    我們一直認為 ASPIRE 數據會首先為我們提供美國的二線適應症,然後是我們在美國以外的市場推出,因為我們必須在註冊後協商定價。

  • Operator

    Operator

  • Mark Schoenebaum, ISI Group.

    ISI 集團的 Mark Schoenebaum。

  • Mark Schoenebaum - Analyst

    Mark Schoenebaum - Analyst

  • My question, number one, has the commercial performance of Kyprolis since the acquisition of Onyx, has it met your expectation, exceeded your expectations, or come in below your expectations?

    我的第一個問題是,自收購 Onyx 以來,Kyprolis 的商業表現是達到您的預期、超出您的預期還是低於您的預期?

  • And number two, I'm sorry to beat this horse, I still do not understand, it's a late night over on the East Coast here.

    第二,我很抱歉打敗了這匹馬,我還是不明白,這裡是東海岸的一個深夜。

  • Still don't understand what exactly happened with Enbrel in the quarter.

    仍然不明白本季度 Enbrel 究竟發生了什麼。

  • You said NRxs are up, but is it your assertion that total patient demand increased 1Q sequentially over the 4Q?

    你說 NRxs 上升了,但你是否斷言患者總需求在第 4 季度連續第 1 季度增加?

  • Thank you very much.

    非常感謝。

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • Thank you Mark, we'll get to both of those questions.

    謝謝馬克,我們會解決這兩個問題。

  • Tony, why don't you start with Kyprolis.

    托尼,你為什麼不從 Kyprolis 開始。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • Starting with Kyprolis, I think the Onyx team, going through the transition and the acquisition, has done a superb job in maintaining FOCUS and keeping the people's attention locked to the business.

    從 Kyprolis 開始,我認為 Onyx 團隊在經歷了過渡和收購之後,在保持焦點和讓人們的注意力鎖定在業務上方面做得非常出色。

  • We continue, as we speak now, to be the number one drug of choice for third line, which is exactly where the label is.

    正如我們現在所說的,我們繼續成為三線藥物的首選藥物,這正是標籤所在的位置。

  • Our market share in this particular indication, we estimate to be at least double that of our nearest competitor.

    我們在這個特定適應症中的市場份額,我們估計至少是我們最接近的競爭對手的兩倍。

  • So, in terms of our ability to deliver value relating to the label, we continue to deliver what we expected.

    因此,就我們提供與標籤相關的價值的能力而言,我們繼續提供我們所期望的。

  • We continue to believe in the drug, that this particular class will be the backbone to treat this disease and we look forward to expanding the label with the second line, and later perhaps the first line data.

    我們繼續相信這種藥物,這一特定類別將成為治療這種疾病的支柱,我們期待用第二線擴展標籤,也許稍後是第一線數據。

  • Let me go back to Enbrel.

    讓我回到 Enbrel。

  • Enbrel, as you know, what happened was purely an additional buy in.

    Enbrel,正如你所知,發生的事情純粹是額外的買入。

  • Because we're shipping biologics, we want to make sure that the product will reach the customer within 48 hours, so therefore, we're very careful about when we ship product.

    因為我們運送生物製劑,我們希望確保產品在 48 小時內到達客戶手中,因此,我們在運送產品時非常小心。

  • The snow delayed some shipments, we held them back, and there was an additional demand, about $120 million that took place in the last week of 2013.

    大雪推遲了一些發貨,我們阻止了它們,並且有額外的需求,大約 1.2 億美元發生在 2013 年的最後一周。

  • The majority of that was Enbrel.

    其中大部分是 Enbrel。

  • When I look at the end market data, to date, in fact, I see growth in both rheumatology and in the dermatology business.

    當我查看終端市場數據時,事實上,到目前為止,我看到風濕病學和皮膚病學業務都有增長。

  • To me, I look at the NRxs as being a predictor of how the business is growing.

    對我來說,我將 NRx 視為業務增長的預測指標。

  • In this particular area for Enbrel, NRxs are about 35% of total TRxs.

    在 Enbrel 的這個特定區域,NRx 約佔總 TRx 的 35%。

  • I do see a distinctive growth between the fourth quarter and the first quarter.

    我確實看到第四季度和第一季度之間出現了明顯的增長。

  • So although the first quarter is expected to be smaller than the fourth quarter, I see a 14% growth in rheumatology, and a 11% growth quarter on quarter in dermatology.

    因此,儘管第一季度預計比第四季度小,但我看到風濕病學增長了 14%,皮膚病學環比增長了 11%。

  • Mark Schoenebaum - Analyst

    Mark Schoenebaum - Analyst

  • Thank you.

    謝謝你。

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • Sharing a lot of data with you there, Mark, but fundamentally we think the demand is intact for Enbrel and the rest of the base business.

    馬克,在那裡與你分享了很多數據,但從根本上說,我們認為 Enbrel 和其他基礎業務的需求是完整的。

  • Okay, let's go to the next question.

    好,我們進入下一個問題。

  • Operator

    Operator

  • Geoff Meacham, JPMorgan.

    傑夫·米查姆,摩根大通。

  • Geoff Meacham - Analyst

    Geoff Meacham - Analyst

  • I have one for Tony on Kyprolis, is there anything on the demand side, either post the ASH meeting, or the market share, that you can talk about on a sequential basis?

    我有一個關於 Kyprolis 的 Tony,在 ASH 會議之後或市場份額方面,您是否可以按順序討論需求方面的內容?

  • And then, one for Sean, also, on Kyprolis, does the slower event rate for FOCUS or ASPIRE, does that change your assumption and make you think differently about the head-to-head study that is ongoing with Velcade?

    然後,對於 Sean,也是在 Kyprolis 上,FOCUS 或 ASPIRE 的事件發生率較低,這是否會改變您的假設並讓您對正在進行的與 Velcade 的頭對頭研究有不同的看法?

  • Thanks.

    謝謝。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • Geoff, thanks for the question.

    傑夫,謝謝你的提問。

  • When we look at our best ability to read end-market demand, we do see positive growth between the fourth quarter of 2013 and the first quarter of 2014.

    當我們審視我們解讀終端市場需求的最佳能力時,我們確實看到了 2013 年第四季度和 2014 年第一季度之間的正增長。

  • Yes.

    是的。

  • It is low single-digit growth.

    這是低個位數的增長。

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • With respect to reading, again, anything through from the time it takes to accrue the last of these events in these type of trials, it is very difficult for me to read anything scientifically, that would project anything about the design or strategy of having the head-to-head studies to Velcade.

    關於閱讀,再一次,從在這些類型的試驗中累積最後這些事件所花費的時間,我很難科學地閱讀任何東西,這會投射出任何關於設計或策略的東西與 Velcade 的面對面研究。

  • I think those remain unrelated in my mind.

    我認為這些在我看來仍然無關。

  • Geoff Meacham - Analyst

    Geoff Meacham - Analyst

  • Okay, thank you.

    好的謝謝你。

  • Operator

    Operator

  • Ian Somaiya, Nomura.

    伊恩·索邁亞,野村證券。

  • Ian Somaiya - Analyst

    Ian Somaiya - Analyst

  • Another question on Kyprolis, maybe just a follow-up to Geoff.

    關於 Kyprolis 的另一個問題,也許只是 Geoff 的後續問題。

  • What would lead to you maybe reconsidering the size of the head-to-head studies versus Velcade?

    什麼會導致您重新考慮頭對頭研究與 Velcade 的規模?

  • What would you need to see in the ASPIRE study or the FOCUS study to maybe have you rethink the sizing, or maybe trying to get the data set before Velcade ultimately goes generic?

    您需要在 ASPIRE 研究或 FOCUS 研究中看到什麼才能讓您重新考慮規模,或者可能在 Velcade 最終成為仿製藥之前嘗試獲取數據集?

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • That is a tough question to answer, are you are asking us to respond to a hypothetical.

    這是一個很難回答的問題,你是在要求我們對一個假設做出回應嗎?

  • Sean, I don't know if you have anything you could add to help?

    肖恩,我不知道你有什麼可以補充的嗎?

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • I think it's relatively unlikely that we will see anything from these two studies, that would change what we are doing in the head-to-head studies.

    我認為我們不太可能從這兩項研究中看到任何東西,這會改變我們在頭對頭研究中所做的事情。

  • They are moving along right now at considerable pace, and changing the design would be potentially challenging to do at this point, anyway.

    他們現在正以相當快的速度前進,無論如何,在這一點上改變設計可能具有挑戰性。

  • I would doubt that the results would warrant that.

    我懷疑結果能否證明這一點。

  • Operator

    Operator

  • Michael Yee, RBC Capital Markets.

    Michael Yee,RBC 資本市場。

  • Michael Yee - Analyst

    Michael Yee - Analyst

  • A question on FOCUS and ASPIRE, from an expectation standpoint, both in the Street and maybe for your expectations.

    一個關於 FOCUS 和 ASPIRE 的問題,從預期的角度來看,無論是在街上還是為了您的期望。

  • Do you believe that FOCUS is a higher risk study than ASPIRE, and if FOCUS, for some reason, does not hit on survival, how confident are we that ASPIRE would still support a European approval, given its PFS endpoint, if you could walk through some of that thinking?

    您是否認為 FOCUS 是一項比 ASPIRE 風險更高的研究,如果 FOCUS 由於某種原因沒有達到生存率,我們對 ASPIRE 仍然支持歐洲批准的信心有多大,鑑於其 PFS 終點,如果您可以通過一些想法?

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • I think probably with FOCUS, you're looking at Kyprolis monotherapy against a combination therapy of some older drugs, that are not used as frequently these days, but do represent standard of care in many of the European countries.

    我想可能在 FOCUS 中,你正在研究 Kyprolis 單一療法與一些老藥的聯合療法,這些老藥現在不那麼頻繁使用,但在許多歐洲國家確實代表了護理標準。

  • That is one picture.

    那是一張照片。

  • The other picture is, of course, you're taking Kyprolis, and you're adding it on top of rev dex, and comparing that to rev dex alone.

    當然,另一張照片是您服用 Kyprolis,將其添加到 rev dex 之上,並將其與單獨的 rev dex 進行比較。

  • I suppose that I could say that the ASPIRE study is most likely to have a positive result, because we know what happens if you put Velcade on top of rev dex, you get a pretty reasonable additional clinical benefit.

    我想我可以說 ASPIRE 研究最有可能產生積極的結果,因為我們知道如果將 Velcade 放在 rev dex 之上會發生什麼,您會獲得相當合理的額外臨床益處。

  • So just from a scientific perspective, that would be how I would look at that.

    所以從科學的角度來看,這就是我的看法。

  • We do believe that the ASPIRE study will stand alone, in leading to an indication for the population that it studies.

    我們確實相信 ASPIRE 研究將獨立存在,為它研究的人群提供指示。

  • It won't cover the later line-type patients who would be the subject of FOCUS, but it will -- we do believe that, in Europe, it will stand alone.

    它不會涵蓋後來成為 FOCUS 主題的線型患者,但它會——我們相信,在歐洲,它會獨立存在。

  • PFS is a very well accepted surrogate endpoint in this particular type of malignancy.

    PFS 是這種特定類型惡性腫瘤中被廣泛接受的替代終點。

  • Michael Yee - Analyst

    Michael Yee - Analyst

  • Thank you.

    謝謝你。

  • Operator

    Operator

  • Ravi Mehrotra, Credit Suisse.

    Ravi Mehrotra,瑞士信貸。

  • Ravi Mehrotra - Analyst

    Ravi Mehrotra - Analyst

  • You touched on this briefly, but just go back to the Prolia ex-US buyback from GSK, was that deal mainly driven by the want and need to change the trajectory of the product, or to lay down operational bedrock?

    你簡要地談到了這一點,但回到從 GSK 回購 Prolia(美國以外)的交易,那筆交易主要是出於改變產品軌蹟的需求,還是奠定了運營基礎?

  • And if the operational bedrock comes in, could you remind us what other ROW infrastructure you've brought in or acquired recently?

    如果運營基石出現,您能否提醒我們您最近引入或收購了哪些其他 ROW 基礎設施?

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • I'm just going to take a crack at the high level, Ravi, and then Tony you can speak to the details of Ravi's question.

    拉維,我只是想談談高層,然後托尼,你可以談談拉維問題的細節。

  • Obviously our business has changed a lot, Ravi, since the time we formed that venture with Glaxo.

    顯然,自從我們與葛蘭素史克成立合資企業以來,拉維,我們的業務發生了很大變化。

  • We have been very successful in expanding internationally over the past several years, including the transactions that we referred to on this call, buying back Neupogen and Neulasta in a number of the markets around the world from Roche.

    過去幾年,我們在國際擴張方面非常成功,包括我們在本次電話會議上提到的交易,從羅氏公司在全球多個市場回購 Neupogen 和 Neulasta。

  • We have a presence now in regions of the world that we didn't previously and we remain very excited about the potential for Prolia, so this was a good opportunity for us to take full control back of that product.

    我們現在在世界上一些我們以前沒有的地區開展業務,我們仍然對 Prolia 的潛力感到非常興奮,因此這是我們完全控制該產品的好機會。

  • We had designed the deal in such a way that we could exit the partnership if we felt it was in our interest to do that, and I think both we and Glaxo felt that we had found a fair way to transition full ownership back to us.

    我們設計的交易方式是,如果我們認為這樣做符合我們的利益,我們可以退出合作關係,而且我認為我們和葛蘭素史克都認為我們找到了一種公平的方式將全部所有權移交給我們。

  • Tony, why don't you talk a little bit about some of the specifics in the marketplace, and why we are optimistic for the growth potential?

    托尼,你為什麼不談談市場的一些細節,以及為什麼我們對增長潛力持樂觀態度?

  • Tony Butler - Analyst

    Tony Butler - Analyst

  • There were a couple of things.

    有幾件事。

  • One, the final label for Prolia was slightly different than what was envisaged when we first did the negotiation.

    第一,Prolia 的最終標籤與我們最初進行談判時的設想略有不同。

  • It is a slightly more focused target audience we call on the [month].

    我們在 [month] 拜訪的目標受眾稍微集中一些。

  • Number two, we have been very successful on our own in developing strong market share with the product, and clearly working in a partnership is not as effective as doing it ourselves.

    第二,我們憑藉自己的產品在開發強大的市場份額方面非常成功,顯然合作夥伴關係不如我們自己做的有效。

  • We truly believe that the clear focus by ourselves will result in us calling on a defined target audience, and having the ability to pick up and grow this business more effectively.

    我們堅信,我們自己明確的重點將使我們呼籲明確的目標受眾,並有能力更有效地開展和發展這項業務。

  • Secondly, that would then result in us having a broader footprint in this particular area.

    其次,這將使我們在這個特定領域擁有更廣泛的足跡。

  • The Filgrastim acquisition gave us rights, in quite a large number of countries around the world, but predominantly increased the size of our businesses in the Middle East, Russia, Latin America, Mexico and Southeast Asia.

    Filgrastim 的收購使我們在全球許多國家獲得了權利,但主要增加了我們在中東、俄羅斯、拉丁美洲、墨西哥和東南亞的業務規模。

  • Those were the big ones.

    那些是大的。

  • Ravi Mehrotra - Analyst

    Ravi Mehrotra - Analyst

  • That's great.

    那太棒了。

  • Thanks.

    謝謝。

  • Operator

    Operator

  • Ying Huang, Barclays.

    英皇,巴克萊銀行。

  • Ying Huang - Analyst

    Ying Huang - Analyst

  • First of all, Tony mentioned that the inventory for this quarter went down from 15 days from last quarter to 13 days.

    首先,Tony 提到本季度的庫存從上一季度的 15 天減少到 13 天。

  • Did I see that stabilizing at this level, or do you continue to see a decline in level for inventory for wholesalers?

    我是否看到穩定在這個水平,或者你是否繼續看到批發商庫存水平下降?

  • Secondly, maybe for Sean, you mentioned that we can't just take default that Kyprolis is outperforming expectation, given that the time had been delayed twice already, so just confirm your view on this.

    其次,對於肖恩,你提到我們不能默認 Kyprolis 的表現超出預期,因為時間已經推遲了兩次,所以請確認你對此的看法。

  • Does that mean also that [comperidome], which is rev dex, is also doing better than the expectation when the trial was designed?

    這是否也意味著 [comperidome],即 rev dex,也比試驗設計時的預期要好?

  • Thank you.

    謝謝你。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • Let me take that inventory question first.

    讓我先解決這個庫存問題。

  • When we look at the average days on hand for 2013, they already fall around 13 days, so we don't think the 13 days is going to be changing much, as we go forward.

    當我們查看 2013 年的平均手頭天數時,它們已經下降到 13 天左右,所以我們認為 13 天不會有太大變化,因為我們會繼續前進。

  • That should be average days as we expect them.

    這應該是我們預期的平均天數。

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • Again, with the situation with these trials, again, when we make these, these are event driven studies and always when we make these estimates, when we expect the events to accrue, there is pretty big confidence around that, and as you get closer, they narrow.

    再一次,對於這些試驗的情況,再一次,當我們進行這些試驗時,這些都是事件驅動的研究,並且總是在我們進行這些估計時,當我們期望事件發生時,人們對此有很大的信心,並且隨著你越來越接近, 他們縮小了。

  • But then as you get towards the end, it becomes really again very stochastic.

    但是當你接近尾聲時,它又變得非常隨機。

  • So you might have, one month you will have nine events, the next month you have two, then you have seven, then you have one.

    所以你可能有,一個月你會有九個事件,下個月你有兩個,然後你有七個,然後你有一個。

  • It's that kind of thing were drawing a projection from those kind of data is very difficult.

    從這些數據中進行預測是非常困難的。

  • I don't think there is, what I have learned over the years, 20 years of doing this is, you can speculate a lot when you are blinded to this kind of thing, and say this could be happening because the treatment effect of the drug is big or the control arm is doing better, or the baseline population that was enrolled is just sicker or less sick than you expect, but you actually have no way of figuring out that, based on a blinded situation that we are in.

    我不認為有,我多年來學到的東西,20 年的工作是,當你對這種事情視而不見時,你可以推測很多,並說這可能會發生,因為治療效果藥物很大,或者控制組做得更好,或者登記的基線人群比你預期的病得更重或更輕,但基於我們所處的盲態情況,你實際上無法弄清楚這一點。

  • I think it is just, you have to wait to get the data.

    我認為這只是,您必須等待才能獲取數據。

  • It is frustrating, I know, but you just have to wait and look at the data, when we get it.

    這令人沮喪,我知道,但你只需要等待並在我們獲得數據時查看數據。

  • Ying Huang - Analyst

    Ying Huang - Analyst

  • Thank you.

    謝謝你。

  • Operator

    Operator

  • Eun Yang, Jefferies.

    恩陽,傑富瑞。

  • Eun Yang - Analyst

    Eun Yang - Analyst

  • Based on what we hear from docs, the average baseline of the LDL levels for studies for PCSK9 inhibitor that could be lower than 100 milligrams per deciliter.

    根據我們從醫生那裡聽到的消息,PCSK9 抑製劑研究的 LDL 水平平均基線可能低於 100 毫克/分升。

  • So question is, are there ultra-low LDL levels where no further benefits can be gained?

    所以問題是,是否存在無法獲得進一步益處的超低 LDL 水平?

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • Well, so, first of all, I don't know where that information comes from, because it is difficult for anybody to know what the average LDL level is, that is accruing in these trials, by running individual study centers, and investigators may have their own individual experiences.

    那麼,首先,我不知道這些信息是從哪裡來的,因為任何人都很難知道平均低密度脂蛋白水平是多少,這是通過運行各個研究中心在這些試驗中累積的,研究人員可能有自己的個人經歷。

  • But in general, which you want to be doing here is targeting people who are still well above the range of the 70, or below, that are still the target that people are looking for, even the new guidelines that are not supposed to be target-based mention repeatedly 70.

    但總的來說,你想在這裡做的是針對那些仍然遠高於 70 或低於 70 範圍的人,這仍然是人們正在尋找的目標,即使是不應該成為目標的新指南基提反复 70。

  • The reason for 70 is largely because when you get below 70, you start seeing the reversal of atherosclerosis, rather than holding it progression.

    70 的原因主要是因為當你低於 70 時,你開始看到動脈粥樣硬化的逆轉,而不是阻止它進展。

  • The question of whether, certainly in absolute terms, as you began to go lower and lower in LDL, the absolute amount of benefit that you would expect to gain with a statin, for example, does go down.

    問題是,從絕對意義上來說,當您的低密度脂蛋白開始越來越低時,您期望通過他汀類藥物獲得的絕對收益是否會下降。

  • In percentage terms, it has been maintained, as far as it has been possible to push LDL.

    就百分比而言,它一直保持到盡可能推動低密度脂蛋白。

  • In large outcomes studies with intensive statin therapy, there, as you might imagine, is a big bell curve of response, in terms of LDL lowering.

    在強化他汀類藥物治療的大型結果研究中,正如您可能想像的那樣,在降低低密度脂蛋白方面存在一條大鐘形反應曲線。

  • And the low end of that bell curve, the tail of that bell curve, those individuals get pushed down quite low, in terms of LDL, and those individuals appear first to have, to the extent that you can make these assessments in as subgroup like that, they appear to have the same degree of benefit, and they appear not to suffer any adverse effects.

    那個鐘形曲線的低端,那個鐘形曲線的尾部,那些人被壓得很低,就低密度脂蛋白而言,這些人似乎首先擁有,在某種程度上你可以像這樣在子組中進行這些評估也就是說,它們似乎具有相同程度的益處,並且似乎沒有遭受任何不利影響。

  • Certainly the genetic data all suggest strongly in humans that there would not be a breakdown of this relationship between LDL and outcomes, or that the safety would be problematic, because it is clear humans can have very low LDL levels, and be just fine.

    當然,所有遺傳數據都強烈表明,人類低密度脂蛋白與結果之間的這種關係不會破裂,或者安全性會有問題,因為很明顯,人類的低密度脂蛋白水平可能非常低,而且很好。

  • Most of us were born, just to remind you, with LDL levels in the 20s, and they climb over time with diet, and so on.

    提醒一下,我們大多數人出生時的低密度脂蛋白水平都在 20 多歲,隨著時間的推移,他們會隨著節食而攀升,等等。

  • I think we are exploring new frontiers here, to be able to push LDL levels down to -- and test whether the lower is better hypothesis continues to be true, as you get into unchartered water.

    我認為我們正在探索新的領域,能夠將低密度脂蛋白水平降低到——並測試越低越好的假設是否仍然正確,因為你進入了未知的水域。

  • My prediction is that it will, but we have to generate the data to see.

    我的預測是它會,但我們必須生成數據才能看到。

  • Operator

    Operator

  • Chris Raymond, Robert Baird.

    克里斯·雷蒙德,羅伯特·貝爾德。

  • Chris Raymond - Analyst

    Chris Raymond - Analyst

  • Just a question on XGEVA.

    只是一個關於 XGEVA 的問題。

  • You mentioned in your prepared remarks, that you are still seeing some generic Zometa impact.

    你在準備好的評論中提到,你仍然看到一些通用的 Zometa 影響。

  • I think it has been over a year now since the first generic Zometa launch, and at least as far as I understand it, the impact is most acute in the first two full quarters of that availability, which I would have thought might have washed out.

    我認為自第一個通用 Zometa 發布以來已經過去了一年多,至少據我所知,影響在該可用性的前兩個完整季度最為嚴重,我認為它可能已經消失了.

  • Can you maybe talk about what other impact you are seeing here?

    你能談談你在這裡看到的其他影響嗎?

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • Chris, this is Tony.

    克里斯,這是托尼。

  • In the US, we saw market share in units grow from about 42% to 43% quarter on quarter, and we saw the dollar value market share grow from 70% to 76% quarter on quarter.

    在美國,我們看到單位市場份額從 42% 環比增長到 43%,我們看到美元價值市場份額環比從 70% 增長到 76%。

  • Zometa went generic in about March last year, and when you think about the ASP plus 6 reporting situation, it is calculated on a rolling 12-month reported two quarters in arrears.

    Zometa 大約在去年 3 月上市,當您考慮 ASP 加 6 報告情況時,它是根據滾動的 12 個月報告的兩個季度欠款計算的。

  • So, by definition, your ASP impact is somewhere between 12 to 18 months.

    因此,根據定義,您的 ASP 影響介於 12 到 18 個月之間。

  • Chris Raymond - Analyst

    Chris Raymond - Analyst

  • Thank you.

    謝謝你。

  • Operator

    Operator

  • Joel Sendek, Stifel.

    喬爾森德克,Stifel。

  • Joel Sendek - Analyst

    Joel Sendek - Analyst

  • Sorry if you might have already mentioned this, but what is the total inventory drawdown for the quarter, and then when might you start or restart the share repurchase?

    抱歉,如果您可能已經提到過這一點,那麼本季度的總庫存減少量是多少,那麼您什麼時候可以開始或重啟股票回購?

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • We will take that in two parts, Joe.

    喬,我們將把它分成兩部分。

  • Tony has talked about inventory build, let us go back through it for you.

    托尼談到了庫存構建,讓我們為您回顧一下。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • Let me remind you again that, historically, our fourth quarter has always been slightly higher than the first quarter.

    再次提醒大家,從歷史上看,我們四季度一直是略高於一季度的。

  • What we do see in 2013 at the end was a strange week at the end, was about $120 million of additional buying by both wholesalers and end-user customers.

    我們在 2013 年底看到的是奇怪的一周,批發商和最終用戶客戶額外購買了大約 1.2 億美元。

  • We think all of this will work through the system during quarter one, and we entered quarter two without any excess inventory.

    我們認為所有這些都將在第一季度通過系統運作,我們進入第二季度時沒有任何庫存過剩。

  • Michael Kelly - Interim CFO

    Michael Kelly - Interim CFO

  • Joel, with respect to buybacks, we're not expecting any major activity this year, but again, cash flow growth was attractive in the first quarter, and we will continue to look for ways to return that to our shareholders, as appropriate through a mix of dividend growth and buybacks.

    喬爾,關於回購,我們預計今年不會有任何重大活動,但同樣,第一季度的現金流增長很有吸引力,我們將繼續尋找方法將其返還給我們的股東,通過適當的方式股息增長和回購的組合。

  • Operator

    Operator

  • Howard Liang, Leerink.

    Howard Liang,Leerink。

  • Howard Liang - Analyst

    Howard Liang - Analyst

  • Couple questions for Sean, first on your thoughts about filing for T-VEC, given the OS data?

    給肖恩幾個問題,首先是關於你對 T-VEC 申請的看法,考慮到 OS 數據?

  • I know you're still talking to regulators, but your thoughts on that would be great.

    我知道你仍在與監管機構交談,但你對此的想法會很好。

  • Second, Blinatumomab, do you already have all the data to potentially file?

    其次,Blinatumomab,您是否已經擁有所有可能歸檔的數據?

  • I know, you're presenting it at ASCO with all the registrational data.

    我知道,您將在 ASCO 上展示它以及所有註冊數據。

  • Sean Harper - Head of R&D

    Sean Harper - Head of R&D

  • T-VEC, we really are fresh with the data, and I think that there is little question that we could file.

    T-VEC,我們對數據非常熟悉,我認為我們可以提出的問題很少。

  • The questions we have to understand are more about the product in its current form, with the formulation and the data that we have in hand from a single study in monotherapy study with physicians, regulars, payers, and figure out what the best way to proceed is.

    我們必須了解的問題更多地是關於當前形式的產品,以及我們從與醫生、常客、付款人進行的單一療法研究中獲得的配方和數據,並找出最好的方法是。

  • We have a lot of sense of value to this product over time, as an important, potentially cornerstone therapy in immunotherapy.

    隨著時間的推移,我們對該產品有很多價值感,它是免疫療法中重要的、潛在的基石療法。

  • So we want to make sure we proceed in the best way possible for this from a long-term view.

    因此,我們希望確保我們從長遠角度出發,以盡可能最好的方式進行。

  • With Blinatumomab, we clearly feel, at this point, that the data set that we generated is worthy of consideration for the filing data we have in hand for filing and approval.

    對於 Blinatumomab,我們清楚地感覺到,在這一點上,我們生成的數據集對於我們手頭備案和批准的備案數據值得考慮。

  • And that is the discussion we are beginning to have with regulators, is around the data set that we actually have in hand.

    這就是我們開始與監管機構進行的討論,圍繞我們實際掌握的數據集展開。

  • Now, that said, we're always accumulating more data.

    現在,也就是說,我們總是在積累更多的數據。

  • As you might recall, we actually started a randomized controlled Phase III study in the same population, and that will be accruing, and we have pediatric programs, et cetera.

    你可能還記得,我們實際上在同一人群中開始了一項隨機對照的 III 期研究,這將會累積,我們有兒科項目,等等。

  • All of those data continue to accrue and all of that information would be submitted in the filing whenever we determine the data cutoff date.

    每當我們確定數據截止日期時,所有這些數據都會繼續累積,並且所有這些信息都將在文件中提交。

  • Operator

    Operator

  • Boris Peaker, Oppenheimer.

    鮑里斯皮克,奧本海默。

  • Boris Peaker - Analyst

    Boris Peaker - Analyst

  • Just have a question on the GCSF franchise.

    只是有一個關於 GCSF 特許經營權的問題。

  • Specifically, how are competitors in the US and Europe positioning themselves in the market, and what do you see their strategy for gaining share in the future over the next few years?

    具體來說,美國和歐洲的競爭對手如何在市場中定位自己,您如何看待他們在未來幾年內獲得市場份額的戰略?

  • And do you see them talking or you aware of them talking to insurance companies, or is that coming back to you in some way in any kind of discussion?

    你是否看到他們在談論或你知道他們在與保險公司交談,或者在任何類型的討論中以某種方式回到你身邊?

  • Just general thoughts of that market intelligence.

    只是對該市場情報的一般想法。

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • It's tough for me to comment on the competitive strategy bars.

    我很難對競爭策略欄發表評論。

  • Probably best to talk to them, but obviously in the US, Granix is not a biosimilar.

    可能最好與他們交談,但顯然在美國,Granix 不是生物仿製藥。

  • It has a very different label to our product and their positioning has been around different product, different price.

    它與我們的產品有非常不同的標籤,它們的定位一直圍繞著不同的產品、不同的價格。

  • In Europe, they have the same situation.

    在歐洲,他們也有同樣的情況。

  • They're having to lean upon their label, which is different than ours, and in both cases the Amgen label is broader, the Amgen label has many more years of experience, much more data around both efficacy and safety, and we have an incredible track record of delivering quality product, on time, every time.

    他們不得不依靠他們的標籤,這與我們的不同,在這兩種情況下,安進標籤都更廣泛,安進標籤有更多年的經驗,更多關於療效和安全性的數據,我們有一個令人難以置信的每次都按時交付優質產品的記錄。

  • Boris Peaker - Analyst

    Boris Peaker - Analyst

  • Have you adjusted your marketing message to some extent to counter detail to Granix?

    您是否在某種程度上調整了您的營銷信息以對抗 Granix 的細節?

  • Tony Hooper - Head of Global Commercial Operations

    Tony Hooper - Head of Global Commercial Operations

  • No.

    不。

  • We still talk about the fact that we have the longest level of data available and we have highest quality product available.

    我們仍然談論這樣一個事實,即我們擁有最長級別的可用數據,並且我們擁有最高質量的產品。

  • Bob Bradway - Chairman & CEO

    Bob Bradway - Chairman & CEO

  • Thanks for dialing in.

    感謝您撥入。

  • Arvind will be around to take questions, if we didn't get to any of you on the call.

    如果我們沒有在電話中聯繫到你們中的任何人,Arvind 將在附近回答問題。

  • We appreciate your interest.

    感謝您的關注。

  • Thanks.

    謝謝。

  • Operator

    Operator

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

    女士們,先生們,安進公司第一季度和財務業績電話會議到此結束。

  • You may now disconnect.

    您現在可以斷開連接。