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Operator
Operator
Good day, everyone, and welcome to Pfizer's Fourth-Quarter 2014 Earnings conference call.
大家好,歡迎參加輝瑞公司 2014 年第四季度收益電話會議。
Today's call is being recorded.
今天的電話正在錄音。
At this time, I would like to turn the call over to Mr. Chuck Triano, Senior Vice President of Investor Relations.
此時,我想將電話轉給投資者關係高級副總裁 Chuck Triano 先生。
Please go ahead, sir.
請繼續,先生。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thank you, operator.
謝謝你,接線員。
Good morning, and thanks for joining us today to review Pfizer's fourth-quarter 2014 performance.
早上好,感謝您今天加入我們,回顧輝瑞公司 2014 年第四季度的業績。
Joined today, as usual, by our Chairman and CEO, Ian Read; Frank D'Amelio, our CFO; Mikael Dolsten, President of Worldwide Research and Development; Albert Bourla, President of Vaccines, Oncology, and Consumer; Geno Germano, President of Global Innovative Pharma; John Young, President of Established Pharma; and Doug Lankler, our General Counsel.
今天像往常一樣,由我們的董事長兼首席執行官 Ian Read 加入;我們的首席財務官 Frank D'Amelio; Mikael Dolsten,全球研發總裁; Albert Bourla,疫苗、腫瘤學和消費者總裁; Geno Germano,全球創新製藥總裁;知名製藥公司總裁 John Young;和我們的總法律顧問 Doug Lankler。
Slides that will be presented on this call can be viewed on our home page, Pfizer.com by clicking on the link for Pfizer Quarterly Corporate Performance, Fourth Quarter 2014, which is located in the Investor Presentations section in the lower right-hand corner of this page.
可以在我們的主頁 Pfizer.com 上查看將在本次電話會議上展示的幻燈片,方法是單擊輝瑞公司 2014 年第四季度季度公司業績鏈接,該鏈接位於本次電話會議右下角的投資者演示部分。這一頁。
Before we start, I'd like to remind you that our discussion during this call will include forward-looking statements and that actual results could differ materially from those projected in the forward-looking statements.
在開始之前,我想提醒您,我們在本次電話會議期間的討論將包括前瞻性陳述,實際結果可能與前瞻性陳述中預測的結果存在重大差異。
The factors that could cause actual results to differ are discussed in Pfizer's 2013 annual report on Form 10-K, and in our reports on Forms 10-Q and 8-K.
輝瑞 2013 年 10-K 表格年度報告以及我們的 10-Q 表格和 8-K 表格報告中討論了可能導致實際結果不同的因素。
Discussions during the call will also include certain financial measures that were not prepared in accordance with Generally Accepted Accounting Principles.
電話會議期間的討論還將包括未根據公認會計原則準備的某些財務措施。
Reconciliation of those non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in Pfizer's current report on Form 8-K dated today, January 27, 2015.
輝瑞公司於 2015 年 1 月 27 日發布的 8-K 表格當前報告中可以找到這些非 GAAP 財務指標與最直接可比的 GAAP 財務指標的對賬。
We will now make prepared remarks, and then we will move to a question-and-answer session.
我們現在將發表準備好的評論,然後我們將進入問答環節。
With that, I'll now turn the call over to Ian Read.
有了這個,我現在將把電話轉給 Ian Read。
Ian?
伊恩?
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Thank you, Chuck, and good morning, everyone.
謝謝你,查克,大家早上好。
We finished 2014 with another quarter of good performance, and met or exceeded every element of our financial guidance for the year.
我們在 2014 年結束時又取得了一個季度的良好表現,並且達到或超過了我們當年財務指導的每一個要素。
Frank will take you through the numbers but before he does, I want to re-emphasize how our four key imperatives have guided the actions we have taken, and the decisions we have made and will continue to guide us going forward.
弗蘭克將帶您了解這些數字,但在他這樣做之前,我想再次強調我們的四個關鍵要求如何指導我們採取的行動,以及我們已經做出並將繼續指導我們前進的決定。
These imperatives are about the steps we are taking to create a sustainable high-value pipeline, effectively and in a disciplined way deploy our capital in ways to create shareholder value, create a culture where colleagues take appropriate risks and accept accountability for their actions, and earn the respect of society.
這些當務之急是關於我們為創建可持續的高價值管道而採取的步驟,以有效且有紀律的方式部署我們的資本,以創造股東價值,營造一種讓同事承擔適當風險並為他們的行為承擔責任的文化,以及贏得社會的尊重。
My remarks today will primarily focus on two of these imperatives, the evolution of our pipeline and how we are creating shareholder value.
我今天的發言將主要集中在其中兩個當務之急,即我們管道的演變以及我們如何創造股東價值。
When we started this journey at the start of 2011, we said improving the performance of our innovative core will be a multi-year endeavor.
當我們在 2011 年初開始這一旅程時,我們曾說過提高我們創新核心的性能將是一項多年的努力。
Over this time, we have significantly changed the composition of our pipeline to have a clearer focus on the therapeutic areas that have strong commercial and scientific potential.
在這段時間裡,我們已經顯著改變了我們管道的組成,更清楚地關注具有強大商業和科學潛力的治療領域。
We have improved productivity in the pipeline.
我們提高了管道中的生產力。
Since undertaking this effort, we have received 16 approvals as of the end of last year, 10 of which were new molecular entities.
自開展這項工作以來,截至去年底,我們已獲得16個批准,其中10個是新分子實體。
Today, we have a total of 86 programs in clinical development, with 29 programs in late stage development or registration.
如今,我們共有86個項目處於臨床開發階段,其中29個項目處於後期開發或註冊階段。
We continue to grow in key areas, most notably in some of our recently launched new products.
我們在關鍵領域繼續增長,尤其是在我們最近推出的一些新產品中。
Eliquis is winning share amongst cardiologists, and moving towards the leading position in the new to brand share in several markets, including the US and Japan.
Eliquis 正在心髒病專家中贏得市場份額,並在包括美國和日本在內的多個市場的新品牌份額中邁向領先地位。
We grew our Xeljanz market share, so it is now ranked number three in new to brand prescription share with rheumatologists, and we are seeing good uptake of our Prevnar 13 adult vaccine following the CDC's Advisory Committee on Immunization Practices recommendation.
我們增加了 Xeljanz 的市場份額,因此它現在在風濕病學家的新品牌處方份額中排名第三,並且我們看到我們的 Prevnar 13 成人疫苗在 CDC 免疫實踐諮詢委員會的建議下得到了很好的吸收。
This is good progress and over the course of the next four years, we expect to have more than 20 Phase 2 and 3 registration study starts and hope to have more than 15 potential approvals, many of them new molecular entities.
這是一個很好的進展,在接下來的四年中,我們預計將啟動 20 多個第 2 期和第 3 期註冊研究,並希望獲得超過 15 個潛在批准,其中許多是新的分子實體。
These numbers do not include study starts and approvals as a result of our Merck KGaA partnership in immunooncology.
這些數字不包括由於我們在免疫腫瘤學領域的默克公司合作而導致的研究開始和批准。
Many of the new molecular entities have the potential to be first-in-class assets that give us growth platforms.
許多新的分子實體有可能成為一流的資產,為我們提供增長平台。
These include the CDK4/6 platform in oncology with Ibrance, or generic name palbociclib, and its potential for indications being studied in the broad spectrum of breast cancer as well as lung, prostate, head and neck, melanoma, ovarian, renal, and brain tumors in young children.
其中包括 Ibrance 的腫瘤學 CDK4/6 平台,或通用名稱 palbociclib,以及其在廣譜乳腺癌以及肺癌、前列腺癌、頭頸癌、黑色素瘤、卵巢癌、腎癌和腦癌中的適應症潛力幼兒腫瘤。
We expect to have a competitive immuno-oncology program.
我們希望有一個具有競爭力的免疫腫瘤學項目。
We believe we have a comprehensive program with all of the elements to be an industry leader.
我們相信我們有一個全面的計劃,其中包含成為行業領導者的所有要素。
Through our partnership with Merck KGaA and their anti-PD-L1, avelumab, we are able to accelerate our participation in the immuno-oncology space, enabling both companies to participate in the first wave of potential single agent monotherapy treatment regiments of several tumor types, some of which we expect to be first or second to market.
通過與默克公司及其抗 PD-L1 藥物 avelumab 的合作,我們能夠加速參與免疫腫瘤學領域,使兩家公司能夠參與第一波潛在的幾種腫瘤類型的單藥單藥治療方案,其中一些我們預計將成為第一或第二上市。
Additionally, through this partnership, we are positioned to be a potential leader in the next wave of I-O combination therapies.
此外,通過此次合作,我們將成為下一波 I-O 聯合療法的潛在領導者。
We expect to be amongst the first three companies in certain cancer indications with monotherapy and a leader with combinations of PD-L1 avelumab, with targeted agents; for example, Inlyta, Xalkori and our second-generation ALK; or dual I-O combinations, for example, 4-1BB, OX-40, ADCs, et cetera; and in various cancer indications.
我們希望成為在某些癌症適應症中使用單一療法的前三家公司之一,並成為 PD-L1 avelumab 與靶向藥物組合的領導者;例如,Inlyta、Xalkori 和我們的第二代 ALK;或雙 I-O 組合,例如 4-1BB、OX-40、ADC 等;以及各種癌症適應症。
This year, we'll be collaborating on up to 20 studies with Merck KGaA, with registrational intent on up to 6 of these studies.
今年,我們將與 Merck KGaA 合作開展多達 20 項研究,其中最多 6 項具有註冊意向。
In addition, through the collaboration, we expect to have 5 different IO drugs in the clinic this year, and up to 10 by 2016.
此外,通過合作,我們預計今年臨床將有 5 種不同的 IO 藥物,到 2016 年將達到 10 種。
This strategy includes: checkpoint inhibitor mAbs, small molecule immuno-modulators, cancer vaccines, bi-functional antibodies, CAR-T cell-based therapy, and antibody drug conjugates.
該策略包括:檢查點抑製劑單克隆抗體、小分子免疫調節劑、癌症疫苗、雙功能抗體、基於 CAR-T 細胞的療法和抗體藥物偶聯物。
Our partner expects to present data from their PD-L1 study at ASCO in June.
我們的合作夥伴預計將於 6 月在 ASCO 展示他們 PD-L1 研究的數據。
To best of our knowledge, it is one of the most comprehensive I-O platforms in development in the pharma industry today.
據我們所知,它是當今製藥行業開發中最全面的 I-O 平台之一。
We also have leading research on JAK biology with potential new indications for Xeljanz in Psoriasis and Psoriatic Arthritis with our oral product, Atopic Dermatitis with a topical formulation, new GI indications in Ulcerative Colitis and Crohn's Disease, and in Ankylosing Spondylitis.
我們還在 JAK 生物學方面進行了領先的研究,我們的口服產品 Xeljanz 在銀屑病和銀屑病關節炎中的潛在新適應症、具有局部製劑的特應性皮炎、潰瘍性結腸炎和克羅恩病的新胃腸道適應症以及強直性脊柱炎。
We have what we believe is a differentiated approach within the PCSK9 area for hyperlipidemia.
我們有我們認為在 PCSK9 領域內針對高脂血症的差異化方法。
Our lead asset, bococizumab, has a differentiated clinical trial design which includes high risk patients and also assesses primary prevention for patients.
我們的主要資產 bococizumab 具有差異化的臨床試驗設計,其中包括高風險患者,並評估患者的一級預防。
In addition to this large molecule approach, we have both a small molecule and a vaccine in development nearing first in human.
除了這種大分子方法外,我們還有一種小分子和一種正在開發中的疫苗,即將首先在人體中使用。
We have made progress with tanezumab, and plan to submit preclinical data to the FDA this quarter in a Complete Response to potentially lift clinical hold on that program.
我們在 tanezumab 方面取得了進展,併計劃在本季度向 FDA 提交臨床前數據,以完成響應,以可能解除對該項目的臨床擱置。
In the Rare Diseases area, we're seeing good progress with enrollment in our Cardiomyopathy Phase 3 program for tafamidis, and are advancing towards Phase 3 with Rivipansel, pending our discussion with the FDA on the final optimization of the formulation.
在罕見病領域,我們看到 tafamidis 的心肌病 3 期計劃的註冊取得了良好進展,並且正在與 Rivipansel 一起推進到 3 期,等待我們與 FDA 討論配方的最終優化。
We have just announced a collaboration with OPKO for a long-acting growth hormone product that we believe could also be first-in-class and further expand that market.
我們剛剛宣布與 OPKO 合作開發一種長效生長激素產品,我們相信該產品也可能是一流的,並進一步擴大該市場。
We have a broad biosimilars portfolio of complex monoclonals.
我們擁有廣泛的複雜單克隆生物仿製藥產品組合。
Of the current pipeline of five assets, three are in ongoing or enrolling Phase 3 trials and include potential biosimilars to Herceptin, Rituxan, and Remicade.
在目前五項資產的管道中,三項正在進行或註冊 3 期試驗,包括赫賽汀、利妥昔單抗和 Remicade 的潛在生物仿製藥。
We have completed a Phase 1 trial for Avastin, and expect to initiate our Phase 3 study later this year, and we have an ongoing Phase 1 proof-of-concept for Humira.
我們已經完成了 Avastin 的第 1 階段試驗,並預計在今年晚些時候啟動我們的第 3 階段研究,我們正在進行 Humira 的第 1 階段概念驗證。
We believe we can become one of the world's preeminent biosimilar companies.
我們相信我們可以成為世界卓越的生物仿製藥公司之一。
There are also several potential acceleration opportunities in the pipeline that include a next generation ALK/ROS-1 inhibitor that holds the potential to significantly extend the lives of patients who no longer respond to Xalkori.
管道中還有幾個潛在的加速機會,包括下一代 ALK/ROS-1抑製劑,該抑製劑有可能顯著延長對 Xalkori 不再有反應的患者的生命。
We expect to start a pivotal study this year.
我們預計今年將開始一項關鍵研究。
As you know, our Staph Aureus vaccine is currently in Phase 2 clinical trials, and was granted Fast Track designation by the US Food and Drug Administration in February 2014.
如您所知,我們的金黃色葡萄球菌疫苗目前處於 2 期臨床試驗階段,並於 2014 年 2 月獲得美國食品和藥物管理局的快速通道指定。
A Phase 2b study that could be registrational is scheduled to start during the middle of this year.
一項可能是註冊的 2b 期研究計劃於今年年中開始。
I am pleased with the progress we have made and in a relatively short period of time in terms of the quality of the assets in our pipeline, and the potential for delivering breakthrough products starting in late 2017 and 2018.
我對我們在相對較短的時間內取得的進展感到高興,因為我們管道中的資產質量,以及從 2017 年底和 2018 年開始交付突破性產品的潛力。
Turning next to how the prudent deployment of capital has yielded significant returns to our shareholders.
接下來談談審慎的資本配置如何為我們的股東帶來可觀的回報。
Over the last four years, we have maintained our operating margins and have taken approximately $5.5 billion out of our operating expenses, during a period where we lost significant revenue to LOEs and co-promote expiries from several high margin products like Lipitor, Enbrel in Canada and the US, and the loss of Spiriva.
在過去的四年裡,我們保持了我們的營業利潤率,並從我們的營業費用中節省了大約 55 億美元,在此期間,我們因 LOE 損失了可觀的收入,並共同促進了加拿大立普妥、Enbrel 等幾種高利潤率產品的到期和美國,以及 Spiriva 的損失。
This year, and for the next couple of years, ongoing expense reductions will result from continuous improvement efforts.
今年以及接下來的幾年,持續的費用削減將來自於持續改進的努力。
However, given that the largest opportunities have already been realized, the amount of potential reductions is more limited.
然而,鑑於最大的機會已經實現,潛在的減排量更加有限。
Also, there are certain areas where we will continue to invest in such as R&D and new product launches.
此外,我們將在某些領域繼續投資,例如研發和新產品發布。
Further, we have returned just over $64 billion to shareholders through share repurchases and dividends over the last four years.
此外,在過去四年中,我們通過股票回購和股息向股東返還了超過 640 億美元。
As we have worked to transform Pfizer, Business Development has been an important enabler of our strategy.
在我們努力改造輝瑞的過程中,業務發展一直是我們戰略的重要推動力。
We have entered into a series of partnerships, in-licensing agreements and made some acquisitions that have bolstered our vaccines portfolio, enhanced our established products portfolio, strengthened our oncology pipeline, expanded our Consumer portfolio, and fortified the set of assets we have across our key therapeutic areas.
我們已經建立了一系列合作夥伴關係、許可協議並進行了一些收購,這些收購增強了我們的疫苗組合、增強了我們現有的產品組合、加強了我們的腫瘤學產品線、擴大了我們的消費者組合,並加強了我們在我們的所有資產中的資產組合。重點治療領域。
Given the strength of our late and mid-stage pipeline, we will evaluate business development opportunities biased towards deals with the potential for creating value in the near term.
鑑於我們後期和中期管道的實力,我們將評估業務發展機會,偏向於在短期內創造價值的潛力。
Beyond business development, here's what you can expect to see from us in terms of additional actions we plan to take in 2015 to create shareholder value.
除了業務發展之外,您還可以從我們那裡看到我們計劃在 2015 年採取的其他行動以創造股東價值。
We will continue to invest in the launch of new products.
我們將繼續投資推出新產品。
We are excited about the potential revenue and continued growth prospects primarily for Eliquis, Xeljanz, Prevnar 13 Adult, Trumenba, Inlyta, Xalkori and Nexium 24HR.
我們對 Eliquis 、 Xeljanz 、 Prevnar 13 Adult 、 Trumenba 、 Inlyta 、 Xalkori 和 Nexium 24HR 的潛在收入和持續增長前景感到興奮。
We expect these products, along with a few others [Vyndaquel, Bosulif, Duavee, and the vaccines acquired from Baxter] including Ibrance's pending approval will generate nearly $2 billion in incremental operational revenue growth this year compared to last.
我們預計這些產品以及其他一些產品 [Vyndaquel、Bosulif、Duavee 和從 Baxter 獲得的疫苗],包括 Ibrance 的待批准,今年將比去年產生近 20 億美元的增量運營收入增長。
So while we expect product launch costs will increase approximately 25% year-over-year, we are seeing good leverage from the investment we are making in these products.
因此,雖然我們預計產品發布成本將同比增長約 25%,但我們看到我們對這些產品的投資具有良好的槓桿作用。
In addition to new launch products, the Innovative business will be focused on growing market share in our major in-line brands like Lyrica, Enbrel outside the US, Viagra in the US, Chantix, and the Prevnar franchise.
除了新推出的產品,創新業務將專注於增加我們主要在線品牌的市場份額,如 Lyrica、美國以外的 Enbrel、美國的偉哥、Chantix 和 Prevnar 特許經營權。
And our Consumer business will be focused on growing its core brands, Advil and Centrum, growing Nexium OTC market share and continuing to pursue Rx to OTC switch opportunities.
我們的消費者業務將專注於發展其核心品牌 Advil 和 Centrum,增加 Nexium OTC 市場份額,並繼續尋求從 Rx 到 OTC 的轉換機會。
For our Established business, we will build on our success in 2014 in providing high-value, high-quality, low-cost treatments in emerging markets.
對於我們已建立的業務,我們將在 2014 年取得成功的基礎上,在新興市場提供高價值、高質量、低成本的治療。
We expect to see operational revenue growth of mid-to-high-single-digits in the emerging markets this year, by focusing on opportunities in key growth markets such as China, Brazil, India, Russia and Turkey.
通過關注中國、巴西、印度、俄羅斯和土耳其等關鍵增長市場的機會,我們預計今年新興市場的營業收入將實現中高個位數增長。
In 2015, we will continue our efforts to establish the groundwork required to be in a position to operationalize a potential split of the Company.
2015 年,我們將繼續努力奠定必要的基礎,以使公司的潛在分拆得以實施。
And we have made good progress on this work.
我們在這項工作上取得了很好的進展。
For 2015, we anticipate the effort that will be required for this work will result in approximately $400 million of one-time costs on a pretax basis.
對於 2015 年,我們預計這項工作所需的工作量將在稅前基礎上產生約 4 億美元的一次性成本。
Let me remind you, at this point in time, we have not yet made a decision to split the Company.
讓我提醒您,目前,我們尚未做出拆分公司的決定。
We have said the final decision will depend upon how our businesses perform in their markets, having a high degree of confidence that the businesses will be successful as standalone entities; and how our shareholders value these businesses -- if the sum of the parts is greater than the whole.
我們曾表示,最終決定將取決於我們的業務在其市場中的表現,並高度相信這些業務將作為獨立實體取得成功;以及我們的股東如何評價這些業務——如果部分的總和大於整體。
And in 2015, we will again be in the position to reduce our adjusted effective tax rate.
2015 年,我們將再次降低調整後的有效稅率。
We expect it will decrease from 26.5% in 2014 to approximately 25% this year.
我們預計它將從 2014 年的 26.5% 降至今年的約 25%。
We will continue to manage our tax line as we do any other expense line, and look to be as efficient as possible.
我們將繼續管理我們的稅收線,就像我們處理任何其他費用線一樣,並儘可能提高效率。
I would note that foreign exchange is one of those items that can either work for us or against us.
我要指出,外匯是對我們有利也可能對我們不利的項目之一。
Most importantly, it is not indicative of how the business is performing in a fundamental manner.
最重要的是,它並不能說明企業的基本表現如何。
As always, all of our decisions will be rooted in how best to strike the right balance in terms of capital deployment, dividends, buybacks and business development.
與往常一樣,我們所有的決定都將植根於如何在資本部署、股息、回購和業務發展方面取得最佳平衡。
One of the reasons I'm confident that we can accomplish all of this is because we have an employee body that is motivated and engaged in the successful execution of the initiatives we have undertaken to drive results.
我有信心我們能夠完成所有這一切的原因之一是因為我們有一個員工團體,它有動力並參與成功執行我們為推動成果而採取的舉措。
Over the past four years, we have created a culture engrained in a strong ownership environment.
在過去的四年裡,我們創造了一種植根於強大的所有權環境的文化。
In summary, we will build on our performance over the past four years to create a sustainable, high value pipeline.
總而言之,我們將在過去四年的業績基礎上打造可持續的高價值管道。
To have market leading strong commercial businesses, to manage our cost structure, and continue to be disciplined in how we deploy our capital.
擁有市場領先的強大商業業務,管理我們的成本結構,並繼續遵守我們如何部署我們的資本。
Collectively, these elements of our strategy that will allow us to generate results and continue to create shareholder value, and it will enable us to bring patients innovative medicines that best meet their needs.
總的來說,我們戰略的這些要素將使我們能夠產生成果並繼續為股東創造價值,並使我們能夠為患者帶來最能滿足其需求的創新藥物。
Now I'll turn it over to Frank for additional details on the quarter, the year, and our finance guidance for 2015.
現在我將把它交給弗蘭克,以了解有關季度、年度和我們 2015 年財務指導的更多詳細信息。
Thank you.
謝謝你。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
Thanks, Ian, and good day, everyone.
謝謝,伊恩,大家好。
As always, the charts I'm reviewing today are included in our webcast.
與往常一樣,我今天查看的圖表包含在我們的網絡廣播中。
I want to remind everybody that as a result of the full disposition of Zoetis on June 24, 2013, the financial results of the Animal Health business and the gain associated with its full disposition are reported as a discontinued operation in the consolidated statements of income for the 12 months ended December 31, 2013.
我想提醒大家,由於 Zoetis 於 2013 年 6 月 24 日進行了全面處置,動物保健業務的財務業績和與其全面處置相關的收益在截至 2013 年 12 月 31 日的 12 個月。
Fourth-quarter 2014 reported revenues of approximately $13.1 billion, which reflects a slight operational increase of $9 million year over year, was mainly driven by the strong performance of Lyrica, Prevnar, and Eliquis in developed markets and Xeljanz which grew primarily in the US.
2014 年第四季度報告的收入約為 131 億美元,這反映了同比 900 萬美元的小幅運營增長,這主要得益於 Lyrica、Prevnar 和 Eliquis 在發達市場的強勁表現以及主要在美國增長的 Xeljanz。
And 7% operational growth in emerging markets, driven by Lipitor mainly in China, as well as Prevnar and Enbrel, which were offset mainly by the unfavorable impact of foreign exchange of approximately $449 million or 3%, the loss of exclusivity for Celebrex in the US, the expiration of the co-promotion term of the collaboration agreement for Enbrel in the US and Canada, and termination of the Spiriva collaboration in certain countries, and other product losses of exclusivity in certain markets.
新興市場的運營增長 7%,主要由立普妥(主要在中國)以及 Prevnar 和 Enbrel 推動,這主要被約 4.49 億美元或 3% 的外匯不利影響所抵消,Celebrex 在美國、Enbrel 在美國和加拿大的合作協議的共同推廣期限到期,以及在某些國家與 Spiriva 合作的終止,以及其他產品在某些市場的排他性喪失。
Adjusted diluted EPS was $0.54 versus $0.56 in the year-ago quarter.
調整後的稀釋後每股收益為 0.54 美元,而去年同期為 0.56 美元。
The decrease was primarily due to a $0.01 negative impact due to foreign exchange; the 4% aggregate operational increase of adjusted cost of sales; adjusted SI&A expenses and adjusted R&D expenses, driven by an unfavorable change in product mix; and increased R&D expenses, due to incremental expenses for the ongoing Phase 3 programs for bococizumab, palbociclib, ertugliflozin and certain other new drug candidates; as well as potential new indications for previously approved products, especially for Xeljanz.
減少的主要原因是外匯帶來的 0.01 美元的負面影響;調整後銷售成本的 4% 總運營增長;由於產品結構的不利變化,調整後的 SI&A 費用和調整後的研發費用;由於 bococizumab、palbociclib、ertugliflozin 和某些其他新候選藥物正在進行的第 3 期項目的費用增加,研發費用增加;以及先前批准的產品的潛在新適應症,尤其是 Xeljanz。
Adjusted SI&A expenses, however, decreased by 2% operationally because of continued benefits for cost reduction and productivity initiatives.
然而,調整後的 SI&A 費用在運營上下降了 2%,因為降低成本和提高生產力計劃的持續收益。
Partially offset by investment to support several recent product launches and other in-line brands.
部分抵消了投資以支持最近的幾個產品發布和其他在線品牌。
Adjusted diluted EPS was favorably impacted by a lower effective tax rate, and fewer diluted weighted average shares outstanding which declined by 159 million shares versus the year-ago quarter, due to ongoing share repurchases.
調整後的攤薄每股收益受到較低有效稅率的有利影響,並且由於持續的股票回購,攤薄加權平均流通股數量減少,與去年同期相比減少了 1.59 億股。
Reported diluted EPS was $0.19 compared with $0.39 in the year-ago quarter, due to the previously mentioned factors, and the unfavorable impact of a charge for the $850 million upfront payment associated with the global strategic alliance formed with Merck KGaA in November of 2014 and an additional amount of approximately $300 million, reflecting the fair value of certain co-promotional rights for Xalkori granted to Merck KGaA; higher charges related to certain legal matters, as well as the higher effective tax rate, all of which were partially offset by lower restructuring charges and purchase accounting adjustments in the fourth quarter of 2014, versus the prior-year quarter.
報告的攤薄後每股收益為 0.19 美元,而去年同期為 0.39 美元,原因是前面提到的因素,以及 2014 年 11 月與默克集團 (Merck KGaA) 建立的全球戰略聯盟相關的 8.5 億美元預付款的不利影響,以及額外金額約 3 億美元,反映授予默克公司的 Xalkori 某些共同推廣權利的公允價值;與某些法律事務相關的更高費用以及更高的有效稅率,所有這些都被 2014 年第四季度與去年同期相比較低的重組費用和採購會計調整所部分抵消。
Foreign exchange negatively impacted fourth-quarter adjusted revenues by $453 million or 3% and positively impacted adjusted cost of sales, adjusted SI&A expenses, and adjusted R&D expenses in the aggregate by $351 million or 4%.
外匯對第四季度調整後的收入產生了 4.53 億美元或 3% 的負面影響,並對調整後的銷售成本、調整後的 SI&A 費用和調整後的研發費用產生了總計 3.51 億美元或 4% 的積極影響。
As a result, foreign exchange negatively impacted fourth-quarter adjusted diluted EPS by approximately $0.01, compared with the year-ago quarter.
因此,與去年同期相比,外匯對第四季度調整後的攤薄每股收益產生了約 0.01 美元的負面影響。
Now moving on to the financial highlights of our business segments.
現在轉到我們業務部門的財務亮點。
In the fourth quarter, Global Innovative Pharmaceutical revenues increased 6% operationally year over year due to the strong operational growth from Lyrica, primarily in the US and Japan, and the performance from recently launched products, including Eliquis globally and Xeljanz primarily in the US.
第四季度,由於 Lyrica(主要在美國和日本)的強勁運營增長,以及最近推出的產品(包括全球 Eliquis 和主要在美國的 Xeljanz)的業績,全球創新製藥收入同比增長 6%。
All of which was somewhat offset by the previously mentioned expiration of the co-promotion term for Enbrel in the US and Canada.
所有這些都被前面提到的 Enbrel 在美國和加拿大的共同推廣期限到期所抵消。
Income before taxes declined 5% operationally due to a 5% operational increase in cost of sales; a 25% operational increase in SI&A expenses, due to increased investment in new products, such as Eliquis and Xeljanz and certain in-line brands; and a 25% operational increase in R&D expenses, due to incremental investment in late stage pipeline products; mainly bococizumab, ertugliflozin, and additional Xeljanz indications.
由於銷售成本增加了 5%,稅前收入在運營上下降了 5%;由於對 Eliquis 和 Xeljanz 等新產品以及某些在線品牌的投資增加,SI&A 的運營費用增加了 25%;由於對後期管道產品的增加投資,研發費用的運營增加了 25%;主要是 bococizumab、ertugliflozin 和其他 Xeljanz 適應症。
Fourth-quarter VOC revenues increased 14% operationally due primarily to the strong performance of Prevnar 13 Adult in the US and Xalkori globally; Inlyta in most markets; and Sutent in emerging markets; as well as Nexium 24HR in the US.
第四季度 VOC 收入在運營上增長了 14%,主要是由於 Prevnar 13 Adult 在美國和全球 Xalkori 的強勁表現;大多數市場的 Inlyta;新興市場的 Sutent;以及美國的 Nexium 24HR。
Income before taxes increased 13% operationally, mainly due to increased revenues which were partially offset by a 12% operational increase in cost of sales, driven by increased sales volumes.
營業稅前收入增長 13%,主要是由於收入增加,但部分被銷售成本增加 12% 所抵消,這主要是由於銷量增加所致。
As a percentage of revenue, the cost of sales decreased by 30 basis points due to a favorable change in product mix.
由於產品組合的有利變化,銷售成本佔收入的百分比下降了 30 個基點。
A 13% operational increase in SI&A expenses, due to investment in Prevnar Adult; as well as launch and pre-launch expenses for Trumenba and Ibrance; and a 17% operational increase in R&D expenses, due to increased investment in the Ibrance and Trumenba development programs; and the global alliance with Merck KGaA.
由於對 Prevnar Adult 的投資,SI&A 費用增加了 13%;以及 Trumenba 和 Ibrance 的啟動和啟動前費用;由於對 Ibrance 和 Trumenba 開發項目的投資增加,研發費用的運營增加了 17%;以及與默克集團的全球聯盟。
In the fourth quarter, Global Established Pharmaceutical revenues decreased 7% operationally year over year, due to the loss of exclusivity of Celebrex in the US, Detrol LA in the US, and Aricept in Canada; as well as the termination of the co-promotion agreement for Spiriva in most countries including the US.
第四季度,由於美國 Celebrex、美國 Detrol LA 和加拿大 Aricept 的排他性喪失,全球成熟製藥業務收入同比下降 7%;以及在包括美國在內的大多數國家終止 Spiriva 的共同推廣協議。
All of these were partially offset by 7% operational growth in emerging markets and the strong performance of Lyrica in Europe.
所有這些都被新興市場 7% 的運營增長和 Lyrica 在歐洲的強勁表現部分抵消。
Income before taxes declined operationally 9%, due to the decrease in revenues; a 5% operational increase; or a 2.3 percentage point increase as a percentage of revenues in cost of sales, due to LOEs and unfavorable changes in product mix; and a 5% operational increase in R&D expenses, primarily due to our biosimilars development program, partially offset by lower clinical trial expenses.
由於收入減少,稅前收入在運營上下降了 9%;運營增長 5%;由於 LOE 和產品組合的不利變化,銷售成本佔收入的百分比增加 2.3 個百分點;研發費用運營增長 5%,主要是由於我們的生物仿製藥開發計劃,部分被較低的臨床試驗費用所抵消。
All of which were partially offset by a 17% operational decrease in SI&A expenses driven be cost reduction and productivity initiatives.
所有這些都被 SI&A 費用的 17% 運營減少部分抵消,這主要是降低成本和提高生產力的舉措。
As you can see, in 2014, we met or exceeded all components of our annual financial guidance.
如您所見,2014 年,我們達到或超過了年度財務指導的所有組成部分。
Now I'd like to walk you through the 2015 guidance ranges for reported revenues, reported diluted EPS and adjusted diluted EPS relative to our 2014 actual results.
現在,我想帶您了解 2015 年報告收入、報告攤薄每股收益和調整後攤薄每股收益相對於我們 2014 年實際結果的指導範圍。
First, it's important to note that the 2015 reported revenues incorporate an anticipated $3.5 billion negative impact due to continuing product losses of exclusivity and declining alliance revenues, which will be partially offset by expected operational growth of certain other products.
首先,值得注意的是,由於獨家產品的持續損失和聯盟收入的下降,2015 年報告的收入包含預期的 35 億美元的負面影響,這將被某些其他產品的預期運營增長部分抵消。
In addition, we expect foreign exchange to have an additional $2.8 billion negative impact on reported revenues.
此外,我們預計外匯將對報告的收入產生額外的 28 億美元負面影響。
Consequently, we expect 2015 reported revenues to be in the range of $44.5 billion to $46.5 billion.
因此,我們預計 2015 年報告的收入將在 445 億美元至 465 億美元之間。
Before moving on, I want to point out that the actual mid-January 2015 rates used to determine our 2015 guidance do not include the impact of a potential devaluation of the Venezuelan bolivar or any other currency.
在繼續之前,我想指出,用於確定我們 2015 年指導的 2015 年 1 月中旬實際匯率不包括委內瑞拉玻利瓦爾或任何其他貨幣可能貶值的影響。
Reported diluted EPS and adjusted diluted EPS also include the negative impact from product losses of exclusivity, a $0.17 negative impact from foreign exchange rates, and a negative $0.03 impact from the pending transaction with OPKO.
報告的攤薄每股收益和調整後的攤薄每股收益還包括產品排他性損失的負面影響、外匯匯率的 0.17 美元負面影響以及與 OPKO 未決交易的 0.03 美元負面影響。
As a result, we expect reported diluted EPS to be in the range of $1.37 to $1.52, and adjusted diluted EPS to be in the range of $2.00 to $2.10.
因此,我們預計報告的攤薄每股收益將在 1.37 美元至 1.52 美元之間,調整後的攤薄每股收益將在 2.00 美元至 2.10 美元之間。
In addition, I want to remind everyone that guidance ranges for both reported and adjusted diluted EPS incorporate $6 billion of anticipated share repurchases in 2015, including $715 million of our shares repurchased to date.
此外,我想提醒大家,報告和調整後的稀釋後每股收益的指導範圍包括 2015 年 60 億美元的預期股票回購,其中包括迄今為止回購的 7.15 億美元股票。
These repurchases will more than offset the potential dilution related to employee compensation programs.
這些回購將抵消與員工薪酬計劃相關的潛在稀釋。
In summary, if you exclude the anticipated FX impacts and the impact of the pending OPKO transaction, our FY15 adjusted diluted EPS guidance midpoint is in line with full year 2014 actual results, despite the $3.5 billion negative impact from expected product LOEs and declining alliance revenues.
總而言之,如果排除預期的外匯影響和未決 OPKO 交易的影響,我們 2015 財年調整後的攤薄每股收益指引中點與 2014 年全年實際結果一致,儘管預期產品 LOE 和聯盟收入下降帶來了 35 億美元的負面影響.
Now I'll review the remaining elements of our 2015 financial guidance.
現在,我將回顧我們 2015 年財務指南的其餘內容。
We expect cost of sales as a percentage of revenue to be in the range of 18.5% to 19.5%.
我們預計銷售成本佔收入的百分比將在 18.5% 至 19.5% 之間。
We expect adjusted SI&A expenses to be in the range of $12.8 billion to $13.8 billion.
我們預計調整後的 SI&A 費用將在 128 億美元至 138 億美元之間。
We expect adjusted R&D expenses to be in the range of $6.9 billion to $7.4 billion, which includes a planned upfront payment of $295 million to OPKO, expected in the first quarter of 2015 upon completion of the transaction announced in December of 2014.
我們預計調整後的研發費用將在 69 億美元至 74 億美元之間,其中包括計劃在 2014 年 12 月宣布的交易完成後於 2015 年第一季度向 OPKO 支付 2.95 億美元的預付款。
We also expect adjusted other income to be approximately $500 million, and we expect our tax rate on adjusted income to be approximately 25%.
我們還預計調整後的其他收入約為 5 億美元,我們預計調整後收入的稅率約為 25%。
Moving on to key take-aways.
繼續討論關鍵要點。
We achieved or exceeded all elements of our full-year 2014 financial guidance in an environment that continues to be challenging.
在充滿挑戰的環境中,我們實現或超過了 2014 年全年財務指導的所有要素。
We advanced our strategy through pipeline advancement and business development.
我們通過管道推進和業務發展來推進我們的戰略。
The FDA approved Trumenba, our meningitis B vaccine, and we announced that we are in labeling discussions with the FDA for Ibrance.
FDA 批准了我們的 B 型腦膜炎疫苗 Trumenba,我們宣布我們正在與 FDA 就 Ibrance 進行標籤討論。
We entered into a collaboration with Merck KGaA which positions us well to potentially compete in the first wave of immuno-oncology therapies, and be a leader in the second wave of combination therapies.
我們與默克公司合作,這使我們有能力在第一波免疫腫瘤療法中競爭,並成為第二波聯合療法的領導者。
Our full year 2015 reported revenue guidance range includes the anticipated negative impact of $3.5 billion due to product loss of exclusivity, and $2.8 billion due to adverse changes in foreign exchange, partially offset by nearly $2 billion of anticipated operational revenue growth in certain products.
我們 2015 年全年報告的收入指導範圍包括由於產品失去排他性而導致的 35 億美元的預期負面影響,以及由於外匯不利變化導致的 28 億美元的預期負面影響,部分被某些產品的預期營業收入增長近 20 億美元所抵消。
The adjusted diluted EPS guidance range includes a $0.17 negative impact from foreign exchange, and a $0.03 negative impact from the planned upfront payment to OPKO.
調整後的稀釋每股收益指導範圍包括來自外彙的 0.17 美元的負面影響,以及來自計劃預付款給 OPKO 的 0.03 美元的負面影響。
We continue to create shareholder value through prudent capital allocation.
我們繼續通過審慎的資本配置為股東創造價值。
Overall in 2014, we returned nearly $12 billion to shareholders through dividends and share repurchases.
總體而言,2014 年,我們通過股息和股票回購向股東返還了近 120 億美元。
From 2011 through 2014, we returned more than $64 billion to shareholders through dividends and share repurchases.
從 2011 年到 2014 年,我們通過股息和股票回購向股東返還了超過 640 億美元。
In addition in 2015, we anticipate returning approximately $13 billion to shareholders through dividends and share repurchases.
此外,我們預計在 2015 年通過股息和股票回購向股東返還約 130 億美元。
Finally, we remain committed to delivering attractive shareholder returns in 2015 and beyond.
最後,我們仍然致力於在 2015 年及以後提供有吸引力的股東回報。
Now I'll turn it back to Chuck.
現在我會把它轉回給查克。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thank you, Frank.
謝謝你,弗蘭克。
Operator, can we please poll for questions.
接線員,我們可以請您投票提問嗎?
Thanks.
謝謝。
Operator
Operator
Thank you.
謝謝你。
(Operator Instructions)
(操作員說明)
Your first question comes from Jami Rubin from Goldman Sachs.
您的第一個問題來自高盛的 Jami Rubin。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you very much.
非常感謝。
Ian, just a question for you, sort of high level.
伊恩,只是問你一個問題,有點高水平。
Based on all the press reports that we're all reading every day, it sounds like you are intensely focused on landing a large target and these articles are all saying most companies are rebuffing you.
根據我們每天都在閱讀的所有新聞報導,聽起來你非常專注於實現一個大目標,而這些文章都在說大多數公司都在拒絕你。
I think this is a great opportunity for you to sort of remind us what are your strategic objectives?
我認為這是一個很好的機會,讓您可以提醒我們您的戰略目標是什麼?
Do you have to make a large transaction?
您必須進行大筆交易嗎?
And if so, is it -- it would seem to me that it's the GEP business that would need the biggest growth drivers, or is it the other areas of the business?
如果是這樣,在我看來,是 GEP 業務需要最大的增長動力,還是該業務的其他領域?
If you could just prioritize for us which of the areas of the business make most sense for you for a large transaction, if indeed that's what you believe you need?
如果您可以為我們優先考慮哪些業務領域對您來說最適合進行大型交易,如果您認為這確實是您需要的?
And then just a second question, maybe this is for Frank.
然後是第二個問題,也許這是給弗蘭克的。
On the GEP business, is it permissible for you guys to buy a foreign Company and use it as a new address when you potentially go to spin out, if you decide to do so, your GEP business?
在 GEP 業務方面,如果您決定拆分您的 GEP 業務,是否允許你們購買一家外國公司並將其用作新地址?
Is that actually an option?
這實際上是一種選擇嗎?
Thanks very much.
非常感謝。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Thank you, Jami, for the question.
謝謝你,傑米,你的問題。
Rumors are rumors.
謠言就是謠言。
We don't comment on rumors or speculation or what they write in the press.
我們不對謠言或猜測或他們在媒體上寫的內容髮表評論。
I would go back to my comment that BD is an enabler of strategies.
我會回到我的評論,即 BD 是戰略的推動者。
Our strategy is to deploy our capital in a way that is shareholder friendly.
我們的戰略是以對股東友好的方式部署我們的資本。
We've been doing that through dividends and buybacks.
我們一直通過股息和回購來做到這一點。
And we have been doing BD.
而且我們一直在做BD。
I would look at BD as a potential always to accelerate incremental value to shareholders.
我會將 BD 視為一種潛力,始終可以加速為股東創造增值。
That's the purpose of deploying that capital, strengthening our businesses.
這就是部署這些資金、加強我們的業務的目的。
And we look at all opportunities to do that, but we do that in a disciplined manner.
我們會尋找所有機會來做到這一點,但我們會以有紀律的方式做到這一點。
We did not push beyond what we thought was reasonable to do the AZ deal.
我們沒有超出我們認為合理的範圍來進行 AZ 交易。
I don't feel that we need to do a large deal.
我不認為我們需要做很多事情。
I do believe, though, that we can deploy capital in a way that it can improve return to shareholders.
不過,我確實相信,我們可以通過一種可以提高股東回報的方式來配置資本。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
And then Jami, on the second question where you were specific to the GEP business.
然後是 Jami,關於第二個問題,您是專門針對 GEP 業務的。
And I think the question was buying a foreign company and potentially changing the address.
我認為問題是購買一家外國公司並可能改變地址。
Now, my answer is, it's kind of one of those things that's almost impossible to speculate upon.
現在,我的回答是,這是幾乎不可能推測的事情之一。
It's very situational, depends on lots of things, valuations, markets and the like.
這是非常情境化的,取決於很多事情、估值、市場等。
Tax reform is an ongoing area where I think that it's still subject to change.
稅收改革是一個持續的領域,我認為它仍然會發生變化。
So I don't want to speculate on what may or may not happen as a result of some hypothetical acquisition.
因此,我不想推測某些假設性收購可能會或可能不會發生什麼。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Frank.
謝謝,弗蘭克。
Operator, can we move to the next question, please.
接線員,我們可以轉到下一個問題嗎?
Operator
Operator
Your next question comes from Chris Schott from JPMorgan.
您的下一個問題來自摩根大通的 Chris Schott。
Chris Schott - Analyst
Chris Schott - Analyst
Great.
偉大的。
Thanks very much.
非常感謝。
Just a couple questions here.
這裡只是幾個問題。
First for Ian.
首先是伊恩。
I believe you mentioned that your business development is now focused on creating value in the near term, given the late-stage pipeline.
我相信您提到,鑑於後期管道,您的業務發展現在專注於在短期內創造價值。
I guess just first of all, is there a shift from prior focus or what we were thinking about in 2014?
我想首先,是否有從之前的焦點或我們在 2014 年考慮的轉變?
And then the second question on business development.
然後是關於業務發展的第二個問題。
When you look at valuations resetting kind of across the biopharma space, is that reducing the opportunity set as you look at these targets, given the valuation discipline you've highlighted for Pfizer?
當您查看整個生物製藥領域的估值重置時,考慮到您為輝瑞(Pfizer)強調的估值紀律,這是否會減少您查看這些目標時設定的機會?
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Well, I think if we'd have been concerned about the state of our research and if we hadn't strengthened our research, which we did with the deal with Merck on the immuno-oncology asset.
好吧,我認為如果我們一直關注我們的研究狀態,並且如果我們沒有加強我們的研究,我們在與默克公司就免疫腫瘤資產的交易中做到了這一點。
Then we may have felt we needed to do more business development in acquiring assets in our research.
然後我們可能覺得我們需要在研究中收購資產方面做更多的業務發展。
But I feel our research pipeline, middle stage to late stage, is strong.
但我覺得我們的研究管道,從中期到後期,很強大。
And I would rather take our capital right now and direct it to opportunities to accelerate EPS growth as I think we've got the right balance of capital allocation in the medium to long term on the innovative side.
我寧願現在就將我們的資金投入到加速每股收益增長的機會中,因為我認為我們在創新方面在中長期資本配置方面取得了適當的平衡。
So it's just really a balance of where you're deploying your capital and where you think you have areas you want to strengthen.
因此,這實際上是在您將資本部署在哪里以及您認為您有想要加強的領域之間取得平衡。
That being said, if there was a piece of intellectual property that added huge value and we thought we could develop it, we would not be shy in acquiring that intellectual property.
話雖如此,如果有一塊知識產權可以增加巨大的價值,並且我們認為我們可以開發它,我們不會害羞地獲得該知識產權。
I do think that the values are high at the moment in their many sectors.
我確實認為目前在他們的許多領域中的價值都很高。
We are disciplined.
我們有紀律。
But when we find an appropriate deal that will meet our strategies of strengthening our businesses and accelerating shareholder value, we feel very comfortable that we have the ability to do those deals.
但是,當我們找到合適的交易來滿足我們加強業務和提高股東價值的戰略時,我們對我們有能力進行這些交易感到非常自在。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Ian.
謝謝,伊恩。
Operator, next question, please.
接線員,請下一個問題。
Operator
Operator
Your next question comes from Mark Schoenebaum from Evercore ISI.
您的下一個問題來自 Evercore ISI 的 Mark Schoenebaum。
Mark Schoenebaum - Analyst
Mark Schoenebaum - Analyst
Thank you very much for taking the question.
非常感謝您提出問題。
First of all, great -- congrats to Frank, great P&L management this quarter, and also for the guidance.
首先,太棒了——恭喜弗蘭克,本季度的損益管理非常出色,也恭喜他的指導。
If I may ask some R&D questions.
如果我可以問一些研發問題。
On the PCSK9 program, could you just update us if you would be willing to do so on the time lines and the enrollment status for the outcomes trial on the PCSK9 program?
關於 PCSK9 計劃,如果您願意就 PCSK9 計劃結果試驗的時間線和註冊狀態更新我們,您能不能告訴我們?
Number two, I was intrigued by your comments during the prepared remarks, Ian, on immuno-oncology where I think you mentioned that you thought you'd be among the first three companies to launch in several or a few tumor types.
第二,Ian 在準備好的關於免疫腫瘤學的評論中,我對你的評論很感興趣,我想你提到你認為你會成為前三家推出幾種或幾種腫瘤類型的公司之一。
Wondering if you'd be willing to tell us what tumor types you think that could be?
想知道您是否願意告訴我們您認為可能是什麼腫瘤類型?
And then finally, on palbo, and I suppose this is more of a commercial question.
最後,關於 palbo,我想這更像是一個商業問題。
But just as we all contemplate a near term launch as a clear possibility, can you help us frame the initial market opportunity?
但是,正如我們都認為近期推出是一種明確的可能性一樣,您能幫助我們確定最初的市場機會嗎?
Do you expect this to be a very rapid cancer launch or something that's a little bit more tempered since these women have a standard of care today?
你認為這是一個非常迅速的癌症發射還是因為這些女性今天有標準的護理而變得更加溫和?
Thank you.
謝謝你。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Thank you, Mark.
謝謝你,馬克。
Good questions.
好問題。
Perhaps Geno can you address the PCSK9 status, and then I'd ask that we'll then move to answer your questions on palbo and which products we think we could be first or second in from Albert.
也許 Geno 你能解決 PCSK9 的狀態,然後我會問我們會回答你關於 palbo 的問題,以及我們認為我們可以從 Albert 獲得第一或第二的產品。
Geno?
熱諾?
Geno Germano - President Global Innovative Pharma
Geno Germano - President Global Innovative Pharma
Sure, Thanks, Mark.
當然,謝謝,馬克。
Regarding the PCSK9 program, our outcomes trials, we're in the process of ramping up site initiation and enrollment.
關於 PCSK9 計劃,我們的結果試驗,我們正在加快站點啟動和註冊的進程。
This is something that we monitor frankly on a daily and weekly basis.
這是我們每天和每週都坦率地監控的事情。
So we're making good progress there.
所以我們在那裡取得了良好的進展。
We expect to be competitive with the other programs from Amgen and Sanofi in terms of timing for completion of those outcomes trials, which we currently see occurring in the late 2017, early 2018 time frame.
我們預計將在完成這些結果試驗的時間方面與安進和賽諾菲的其他項目競爭,我們目前看到這些試驗發生在 2017 年末、2018 年初的時間框架內。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Thank you, Geno.
謝謝你,杰諾。
Albert?
阿爾伯特?
Albert Bourla - President Oncology, Vaccines & Consumer
Albert Bourla - President Oncology, Vaccines & Consumer
Yes.
是的。
On the question on the initial Ibrance launch uptake.
關於初始 Ibrance 啟動吸收的問題。
We are very excited about this initial launch for two main reasons.
我們對首次發布感到非常興奮,主要有兩個原因。
First, we have not seen an approval of a new therapy in first-line advanced [breast] cancer in over 10 years.
首先,10 多年來,我們還沒有看到一線晚期 [乳腺癌] 新療法獲得批准。
So there is a great unmet need.
所以有一個很大的未滿足的需求。
And secondly, Ibrance has demonstrated not only a statistical significant improvement, but more importantly a clinically meaningful benefit to patients because that would be a first, and added 10 months to the standard of care.
其次,Ibrance 不僅表現出統計學上的顯著改善,而且更重要的是對患者有臨床意義的益處,因為這將是第一次,並增加了 10 個月的護理標準。
As a result, we expect the uptake to be robust.
因此,我們預計吸收將強勁。
Having said that, as with all launches, there will be some oncologists that will be early adopters, while others will wait for additional data or more experience in the field.
話雖如此,與所有發布一樣,會有一些腫瘤學家將成為早期採用者,而其他人將等待更多數據或該領域的更多經驗。
But for this group, we already have four Phase 3 trials ongoing, two of which are expected to complete this year.
但對於這個群體,我們已經進行了四項 3 期試驗,其中兩項預計將於今年完成。
Let me say that we are working to build a broad franchise around breast cancer.
讓我說,我們正在努力圍繞乳腺癌建立廣泛的特許經營權。
We are starting with first-line metastatic breast cancer.
我們從一線轉移性乳腺癌開始。
And then we are moving fast to recurrent advanced and then to early breast cancer.
然後我們正在快速轉向復發性晚期乳腺癌,然後轉向早期乳腺癌。
And I'd like to remind everyone, that we are currently running Phase 3 pivotal registration enabling studies for all of these indications.
我想提醒大家,我們目前正在針對所有這些適應症進行第三階段關鍵註冊研究。
Now, to your question on immuno-oncology.
現在,關於免疫腫瘤學的問題。
As Ian said, this deal is transformational for our immuno-oncology program for two reasons.
正如 Ian 所說,這筆交易對我們的免疫腫瘤學項目具有變革性,原因有兩個。
And the first is that it will enable us to quickly move into the first wave of potential monotherapy treatments.
首先是它將使我們能夠迅速進入第一波潛在的單一療法治療。
You asked for some examples of that; examples would be ovarian or gastric for example.
你問了一些例子;例如卵巢或胃。
And this is where we are going to see to put our emphasis rather than on indications that are more crowded as melanoma, for example.
例如,這就是我們將重點放在而不是像黑色素瘤這樣更擁擠的適應症的地方。
But don't forget the second also benefit, which is enable us to accelerate our combinations program by more than two-and-a-half years.
但不要忘記第二個好處,它使我們能夠將我們的組合計劃加速超過兩年半。
This acceleration in conjunction with our broad range of combination therapies with, Xalkori, Inlyta, Ibrance, ALK/ROS inhibitor, OX40, 4-1BB, will enable us to be the leading player in the second wave where we see also a much greater portion of the [inaudible].
這種加速與我們與 Xalkori、Inlyta、Ibrance、ALK/ROS 抑製劑、OX40、4-1BB 的廣泛聯合療法相結合,將使我們成為第二波的領先者,我們也看到更大的部分[聽不清]。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Thank you, Albert.
謝謝你,阿爾伯特。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Albert.
謝謝,阿爾伯特。
Operator, next question, please.
接線員,請下一個問題。
Operator
Operator
Your next question comes from Gregg Gilbert from Deutsche Bank.
您的下一個問題來自德意志銀行的 Gregg Gilbert。
Gregg Gilbert - Analyst
Gregg Gilbert - Analyst
Thanks, good morning.
謝謝,早上好。
A couple unrelated questions.
幾個無關的問題。
First, Ian to slice the M&A question a different way, it's clear you have a sense of urgency to find deals that could be -- if they're shareholder enhancing.
首先,伊恩以不同的方式剖析併購問題,很明顯你有一種緊迫感,可以找到可能的交易——如果它們能增強股東利益的話。
Would you care to comment on the sense of urgency to supplement the Innovative versus the Established Products?
您是否願意評論一下補充創新產品與既定產品的緊迫感?
You've made it clear that you'd rather have near term accretion or value accretion versus long-term, but I want to make sure we understand that you're still committed to both or is one taking precedent?
你已經明確表示你寧願短期增值或價值增值而不是長期,但我想確保我們理解你仍然致力於兩者還是一個先例?
Secondly, can you comment on Lyrica CR?
其次,你能評論一下 Lyrica CR 嗎?
Obviously, a large product that gets almost no focus.
顯然,一個幾乎沒有焦點的大型產品。
Are you planning to attempt a filing there to protect at least some of that franchise longer term?
您是否打算嘗試在那裡申請以至少長期保護該特許經營權的一部分?
And lastly, Albert, can you comment on Prevnar Adult versus pediatric and the progress there?
最後,Albert,您能否評論一下 Prevnar 成人與兒科以及那裡的進展?
And maybe share some color around the split between those two important buckets.
也許在這兩個重要的桶之間的分裂周圍分享一些顏色。
Thank you.
謝謝你。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Geno, do you want to talk about Lyrica first, and then Albert can talk about the vaccine, and I'll come back on our BD preferences or priorities.
Geno,你想先談談 Lyrica,然後 Albert 可以談談疫苗,我會回到我們的 BD 偏好或優先事項。
Geno Germano - President Global Innovative Pharma
Geno Germano - President Global Innovative Pharma
So, Gregg, on the Lyrica program, we continue to advance the CR program for Lyrica.
所以,Gregg,在 Lyrica 計劃上,我們繼續推進 Lyrica 的 CR 計劃。
We have completed several trials, and seen positive outcomes.
我們已經完成了幾項試驗,並看到了積極的結果。
So we're continuing to move towards a registration, and we expect to see a registration potentially ahead of the expiration of the exclusivity in the United States.
因此,我們將繼續進行註冊,我們預計可能會在美國的排他性到期之前看到註冊。
Albert Bourla - President Oncology, Vaccines & Consumer
Albert Bourla - President Oncology, Vaccines & Consumer
Yes, Gregg, on the Adult, although early, we are very pleased with the launch.
是的,格雷格,在成人版上,雖然很早,但我們對發布感到非常滿意。
And we believe it is potentially a very large and durable opportunity, given current demographics and aging trends.
鑑於當前的人口結構和老齡化趨勢,我們認為這可能是一個非常巨大且持久的機會。
The Adult sales in the US were around $250 million, which was driven by higher penetration during the high flu season and of course also some inventory stocking with new customers.
美國的成人銷售額約為 2.5 億美元,這是由於流感高發季節的滲透率較高,當然還有一些新客戶的庫存庫存。
Our market share jumped almost four times to 45% from 12% originally.
我們的市場份額從最初的 12% 增長了近四倍至 45%。
Growth moving forward, we still expect to be strong throughout the year.
向前發展,我們仍然預計全年將保持強勁勢頭。
Of course, keep in mind that this quarter was influenced by seasonality and some inventory build, and that can vary quarter by quarter.
當然,請記住,本季度受季節性因素和一些庫存增加的影響,並且可能會因季度而異。
On the pediatric that you asked, pediatric in fact was down this quarter due to the timing of a CDC purchases, which last year occurred in fourth quarter, and this year in third quarter.
關於你問的兒科,事實上,由於 CDC 購買的時間安排在本季度,兒科下降了,去年發生在第四季度,今年在第三季度。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Thank you.
謝謝你。
On the urgency to do business development, let me stress, the urgency I have is to create shareholder value.
關於企業發展的緊迫性,我要強調,我的緊迫性是創造股東價值。
And if business development can do that then we will move on business development with urgency.
如果業務發展能夠做到這一點,那麼我們將緊急推進業務發展。
I don't really have a preference between strengthening either of the businesses.
在加強這兩個業務之間,我真的沒有偏好。
I think we can use business development to improve and strengthen both of them, and we will look at deals and if the deals make sense we will attempt to execute them.
我認為我們可以利用業務發展來改善和加强两者,我們將研究交易,如果交易有意義,我們將嘗試執行它們。
Thanks for the question.
謝謝你的問題。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thank you.
謝謝你。
Operator, next question, please.
接線員,請下一個問題。
Operator
Operator
Your next question comes from Tim Anderson from Bernstein.
您的下一個問題來自 Bernstein 的 Tim Anderson。
Tim Anderson - Analyst
Tim Anderson - Analyst
Hello.
你好。
I'm sorry, it's the same line of questioning but on inversion.
對不起,這是同一行提問,但在倒置上。
So is that, in your view, pretty much off the table at this point for Pfizer or is that still something that you think you can pursue?
那麼,在您看來,對于輝瑞來說,這在這一點上幾乎是不可能的,還是您認為您仍然可以追求的東西?
And then also on inversion, any visibility on when or whether Treasury might come out with a second round of regulations?
然後在倒置方面,關於財政部何時或是否會出台第二輪監管的任何可見性?
Then on the pipeline, apart from palbo, if you had to pick two compounds that excite you the most, what would those be?
然後在管道上,除了 palbo,如果你必須選擇兩種最讓你興奮的化合物,那會是什麼?
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Okay.
好的。
So on the inversion, Tim, inversions have not been stopped.
所以在反轉上,蒂姆,反轉並沒有停止。
What the potential rules of the government have done is delayed the value or potentially delayed the value realization of the inversion.
政府的潛在規則所做的是延遲了價值或潛在地延遲了倒置的價值實現。
So, inversions I think are being tempered by the ability to pay the target's price, given the slower realization of the inversion values.
因此,鑑於反轉值的實現速度較慢,我認為反轉正在受到支付目標價格的能力的影響。
I think it's an area that will remain fertile, while there's no change in the US tax laws.
我認為這是一個將保持肥沃的領域,而美國稅法沒有變化。
I think it's -- we're in a very uncompetitive situation with our tax code, and inversions will continue to be important as an instrument of increasing shareholder value just depending on the price you need to pay to affect the inversion.
我認為這是 - 我們的稅法處於非常沒有競爭力的情況下,倒置將繼續作為增加股東價值的重要工具,這取決於你需要支付的影響倒置的價格。
And the exact conditions of the inversion, which are very technical, depending on how you can manage your subsequent cash flows.
反轉的確切條件非常技術性,取決於您如何管理後續現金流。
So it's a very -- it's not an easy, general answer to what type of inversion you would want to do.
所以這是一個非常 - 對於您想要做哪種類型的反轉,這不是一個簡單的通用答案。
Apart from palbo, I think we have a lot of exciting products.
除了palbo,我認為我們還有很多令人興奮的產品。
I would probably talk about the ability to bring the Staph Aureus vaccine to market as quickly as possible.
我可能會談論盡快將金黃色葡萄球菌疫苗推向市場的能力。
I think bococizumab clearly has a huge potential.
我認為 bococizumab 顯然具有巨大的潛力。
I think we're well placed with the clinical trial design.
我認為我們在臨床試驗設計方面處於有利地位。
Ertugliflozin is well positioned.
Ertugliflozin 的定位很好。
Adult vaccine, which we've just launched, has a huge potential.
我們剛剛推出的成人疫苗具有巨大的潛力。
So I find it difficult to really pick just two assets.
所以我發現很難真正選擇兩種資產。
I think we have a lot of assets that we can create value from, and especially the total life cycle of palbociclib.
我認為我們有很多可以創造價值的資產,尤其是 palbociclib 的整個生命週期。
So our new Treasury regulations, I don't know.
所以我們的新財政部規定,我不知道。
I'm not in Washington.
我不在華盛頓。
I can't comment.
我無法評論。
They have published a rule.
他們發布了一條規則。
They haven't finalized the rule.
他們還沒有最終確定規則。
And clearly, there's an intent to do that.
顯然,有這樣做的意圖。
There's an intent to make it somewhat more problematic for people to plan inversions, and we'll just have to work around that.
有一個意圖是讓人們計劃倒置變得更加困難,我們只需要解決這個問題。
Thank you.
謝謝你。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Ian.
謝謝,伊恩。
Operator, moving on, please.
接線員,請繼續。
Operator
Operator
Your next question comes from Vamil Divan from Credit Suisse.
您的下一個問題來自瑞士信貸的 Vamil Divan。
Vamil Divan - Analyst
Vamil Divan - Analyst
Thanks for taking my questions.
感謝您提出我的問題。
I have two.
我有兩個。
One I guess, the first one is more for Ian, obviously a lot of discussion around the M&A and what you guys are looking to do.
一個我猜,第一個更適合伊恩,顯然圍繞併購以及你們想要做什麼進行了很多討論。
I guess just strategically, some comments earlier about valuations and people you're approaching, maybe not wanting to go ahead with a deal.
我想只是從戰略上講,之前有一些關於估值和你正在接近的人的評論,可能不想繼續進行交易。
I'm thinking strategically, isn't it tougher for you to consummate a deal when you're being so public talking about the need to do something?
我在戰略上思考,當你如此公開談論需要做某事時,你完成交易不是更難嗎?
And the near term focus that you're mentioning now, doesn't that make it tougher to get a deal done and doesn't it just raise the prices higher?
而你現在提到的近期焦點,這不是讓交易變得更難完成嗎?它不只是抬高了價格嗎?
And then, the second one is more on the pipeline.
然後,第二個正在籌備中。
If you could talk about I-O, appreciate the comments you gave earlier and thanks for all that.
如果您可以談論 I-O,請感謝您之前提供的評論並感謝您所做的一切。
Can you talk a little bit about, on the biomarker side if there's anything you can share how you're planning to incorporate biomarkers at least into this first wave of studies that you've outlined here for this year?
您能否談談生物標誌物方面的問題,如果您可以分享您計劃如何將生物標誌物至少納入您今年在這裡概述的第一波研究中?
Thanks.
謝謝。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Vamil, I'm intrigued by your comments.
瓦米爾,我對你的評論很感興趣。
I don't think I've ever said we have to do a deal.
我想我從來沒有說過我們必須達成協議。
I think you're reading the press rather than what I've been saying.
我想你是在看新聞而不是我一直在說的。
If I felt there was a pressure to do a deal, we would have done the deal we were trying to do last year.
如果我覺得做交易有壓力,我們會做我們去年試圖做的交易。
We are very disciplined.
我們非常有紀律。
We don't feel we need to do a big deal.
我們覺得我們不需要做大事。
I do feel that we have the ability and we have the balance sheet that we can use if business development can further our base of strategies, which is to strengthen either one of our businesses or to acquire in an area like immuno-oncology, which we did to strengthen where we see we can create synergy and value.
我確實認為我們有能力並且我們擁有可以使用的資產負債表,如果業務發展可以進一步推進我們的戰略基礎,即加強我們的一項業務或收購像免疫腫瘤學這樣的領域,我們確實加強了我們認為可以創造協同效應和價值的地方。
So I'm a little mystified about your comment about that Pfizer needs to do a deal.
所以我對你關于輝瑞需要做交易的評論有點迷惑。
I think there's a lot of rumors running around.
我認為有很多謠言四處流傳。
We, as like any management team, look at opportunities.
我們和任何管理團隊一樣,都在尋找機會。
We have the capital and the wherewithal to do the deal, should we so decide.
如果我們這樣決定,我們有足夠的資金和資金來進行交易。
I don't think it's a matter of is there value, and if there's value we can get the deal done.
我認為這不是有價值的問題,如果有價值,我們就可以完成交易。
So I'm a little -- I hope that puts in perspective for all of you where we sit on business development deals.
所以我有點——我希望這對我們在業務發展交易中的所有人都有看法。
Good to do if they create shareholder value, disciplined.
如果他們創造股東價值,紀律嚴明,那就太好了。
If they don't, we're not doing them.
如果他們不這樣做,我們就不會這樣做。
Biomarkers.
生物標誌物。
Mikael Dolsten - President Worldwide Research & Development
Mikael Dolsten - President Worldwide Research & Development
So that's a great question on how you bring immuno-oncology to the next level.
所以這是一個很好的問題,關於如何將免疫腫瘤學提升到一個新的水平。
First, as you know, we have considerable experience in selecting and developing biomarkers from Xalkori, where we've obviously linked that to the drug's efficacy, and we have also learned how to drive uptake of that diagnostic to very high rates in the marketplace.
首先,如您所知,我們在選擇和開發 Xalkori 生物標誌物方面擁有豐富的經驗,我們顯然已經將其與藥物的功效聯繫起來,並且我們還學會瞭如何將這種診斷方法的採用率提高到市場上非常高的水平。
Specifically for immuno-oncology, so in our partnership on avelumab, we certainly are looking at PD-L1, high versus low tumors.
特別是針對免疫腫瘤學,因此在我們與 avelumab 的合作中,我們當然正在研究 PD-L1,即高腫瘤與低腫瘤。
And the data we see really correlates, as expected, with high response in the PD-L1 high, but we also see responses in the PD-L1 low.
正如預期的那樣,我們看到的數據確實與 PD-L1 高響應的高響應相關,但我們也看到 PD-L1 低響應。
We have a second wave, as you heard from Albert, on the 4-1BB and OX-40 for combination.
正如您從 Albert 那裡聽到的,我們有第二波,用於 4-1BB 和 OX-40 的組合。
We think that the 4-1BB is unique in amplifying cytotoxic cells, CD8 cells.
我們認為 4-1BB 在擴增細胞毒性細胞 CD8 細胞方面是獨一無二的。
So we certainly will look for expression of those cells in the tumor.
所以我們當然會尋找這些細胞在腫瘤中的表達。
Similarly for OX-40, we think it's more on the CD4 side, so that will be another marker to monitor.
同樣對於 OX-40,我們認為它更多的是在 CD4 方面,所以這將是另一個需要監控的標記。
But we also have programs coming on-board for key regulatory cells that may limit the overall immuno-oncology response and tumor suppressing macrophages.
但我們也有針對可能限制整體免疫腫瘤反應和腫瘤抑制巨噬細胞的關鍵調節細胞的計劃。
And we have assets coming within the next year or so on each of those particular subsets of immuno-oncology, and of course our ADC portfolio is very much supported by diagnostic.
我們在明年左右的每個特定免疫腫瘤學子集中都有資產,當然我們的 ADC 產品組合得到了診斷的大力支持。
We have now two ADC's in Phase 1 that show interesting responses, and we stocked enriched by diagnostic for those.
我們現在有兩個處於第 1 階段的 ADC,它們顯示出有趣的反應,我們通過診斷豐富了這些 ADC。
So I hope you get the sense that we go from standard diagnostic to more next-generation diagnostic, and we'll also do the kind of future diagnostic looking at circulating tumor cells to make it even more easy to integrate in medical practice.
所以我希望你能理解我們從標準診斷轉向更新一代的診斷,我們還將對循環腫瘤細胞進行未來的診斷,使其更容易融入醫療實踐。
So we really see us being a driver of this change and a pioneer in this area.
所以我們真的認為我們是這一變化的推動者和該領域的先驅。
Thank you.
謝謝你。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks for the background, Mikael.
謝謝你的背景,米凱爾。
Next question, please.
下一個問題,請。
Operator
Operator
Your next question comes from John Boris from SunTrust.
您的下一個問題來自 SunTrust 的 John Boris。
John Boris - Analyst
John Boris - Analyst
Thanks for taking the questions.
感謝您提出問題。
First question, just going back to business development as an enabling strategy, Ian.
伊恩,第一個問題,回到業務發展作為一種有利的戰略。
I think you had indicated that one of the primary reasons for the AstraZeneca transaction was the tax considerations obviously around the inversion, and being able to unleash the value of the cash that you have trapped offshore.
我認為您曾表示,阿斯利康交易的主要原因之一顯然是圍繞倒置的稅收考慮,以及能夠釋放您在海外滯留的現金的價值。
If you go back and look at the last transaction, your tax rate around that time was around 22%.
如果您回過頭來查看最後一筆交易,您當時的稅率約為 22%。
It's gone as high as 27%, not enabling you to bring that cash back.
它已經高達 27%,無法讓您拿回現金。
How much consideration is there that when you do a transaction, how much impact on the tax rate are you willing to absorb if it is a US asset that you're looking to you acquire?
當您進行交易時,如果您希望獲得的是美國資產,您願意承擔多少對稅率的影響?
Second question for Frank.
弗蘭克的第二個問題。
You've disclosed what the impact of foreign exchange is.
您已經披露了外彙的影響。
Can you articulate or quantify what the impact is on volume and price on growth in 2014?
您能否闡明或量化 2014 年增長對數量和價格的影響?
And then last question on R&D and Xeljanz in EU.
最後一個關於歐盟研發和 Xeljanz 的問題。
Any update on your ability to file Xeljanz in Europe?
您在歐洲提交 Xeljanz 的能力有什麼更新嗎?
And then the implications for the Enbrel field force over there, especially in light of Samsung filing their SB4 and anticipating to be commercializing it, at least Biogen Idec commercializing Enbrel in the back half and how you're going to be adjusting for that resource if you don't have Xeljanz there.
然後是對那裡的 Enbrel 現場部隊的影響,特別是考慮到三星提交他們的 SB4 並預計將其商業化,至少 Biogen Idec 在後半部分將 Enbrel 商業化,以及如果你將如何調整該資源,如果你那裡沒有 Xeljanz。
Thanks.
謝謝。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
John, thank you.
約翰,謝謝。
As always, good questions.
一如既往,好問題。
Why don't you, Geno, deal with the whole issue of Xeljanz in Europe.
Geno,你為什麼不處理整個歐洲的 Xeljanz 問題。
And then Frank can look at the volume question, and then I'll come back to your rather complicated question on inversions and tax rates and perhaps Frank will also help me out there a bit.
然後弗蘭克可以看看數量問題,然後我會回到你關於倒置和稅率的相當複雜的問題,也許弗蘭克也會幫我一些忙。
Geno Germano - President Global Innovative Pharma
Geno Germano - President Global Innovative Pharma
So, John, regarding Xeljanz and the Enbrel inflammation business in Europe, we remain committed to resubmitting for approval in RA for Xeljanz in Europe.
因此,John,關於 Xeljanz 和歐洲的 Enbrel 炎症業務,我們仍然致力於重新提交歐洲 Xeljanz 的 RA 批准。
We have had recent interactions with regulators there, and a discussion on our plans for resubmission.
我們最近與那裡的監管機構進行了互動,並討論了我們重新提交的計劃。
We were encouraged by those discussions.
我們對這些討論感到鼓舞。
We continue to collect additional clinical data to support that resubmission, and our expectations are that we will resubmit by the end of the year in 2015.
我們繼續收集更多的臨床數據來支持重新提交,我們的預期是我們將在 2015 年年底之前重新提交。
Regarding Enbrel and potential competition, we see the introduction of biosimilars into the marketplace in Europe as something that's more evolutionary than transitionary.
關於 Enbrel 和潛在的競爭,我們認為將生物仿製藥引入歐洲市場是一種進化而非過渡。
And we expect to continue to support Enbrel through the near term, and realize continued support from that franchise.
我們希望在短期內繼續支持 Enbrel,並實現該特許經營權的持續支持。
So I don't see a disruption at this point with the timing that we're anticipating and the impact that we see projected for biosimilars.
因此,在這一點上,我認為我們預期的時機以及我們看到的對生物仿製藥的預期影響都沒有出現中斷。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
And of course, that market in Europe is very under-penetrated given their reluctance.
當然,鑑於他們的不情願,歐洲市場的滲透率非常低。
So there's a lot of volume there that can be accessed via biosimilars as well as the original.
因此,那裡有很多可以通過生物仿製藥以及原始產品獲得的數量。
Frank?
坦率?
Frank D'Amelio - CFO
Frank D'Amelio - CFO
John, for the quarter, this is Company-wide.
約翰,對於本季度,這是全公司範圍的。
So price was plus 1%.
所以價格加了1%。
Volume was minus 1%.
成交量為負 1%。
Foreign exchange was minus 3%.
外彙為-3%。
FX drove the minus 3% for the quarter.
外匯推動了本季度的負 3%。
And as I mentioned on my comments, we're actually up operationally by $9 million, excluding foreign exchange for the quarter.
正如我在評論中提到的那樣,我們實際上在運營上增加了 900 萬美元,不包括本季度的外匯。
For the full year, price was plus 2%, the volume was minus 4%, FX was minus 2%.
全年,價格上漲 2%,成交量下跌 4%,外匯下跌 2%。
If you put that together, you get the minus 4% that we reported for the year.
如果你把這些放在一起,你會得到我們今年報告的負 4%。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Thank you.
謝謝你。
And on the BD, I think my comments on AZ have always been that we looked at three components of value.
在 BD 上,我認為我對 AZ 的評論一直是我們著眼於價值的三個組成部分。
One was their pipeline, two was the amount of operational synergies that could be achieved, and third was the financial synergies.
一是他們的管道,二是可以實現的運營協同效應的數量,第三是財務協同效應。
And we were disciplined in our approach because the financial synergies were the most risky part of the equation, and in fact were made eventually more difficult to achieve by the proposed rules.
而且我們的方法是自律的,因為財務協同效應是等式中風險最大的部分,事實上最終通過擬議的規則更難以實現。
I think the net-net answer to your question about tax rates is, it all goes into the value.
我認為你關於稅率的問題的淨答案是,這一切都體現在價值中。
What is the value of the acquisition we're trying to achieve, what's the value we create for shareholders?
我們試圖實現的收購價值是什麼,我們為股東創造的價值是什麼?
And the tax rate, just like the synergies, just like expenses, just like everything else, is part of that value equation.
稅率,就像協同效應一樣,就像費用一樣,就像其他一切一樣,是價值等式的一部分。
If it works, the value works, we'll do the deal.
如果它有效,價值有效,我們將進行交易。
If the value doesn't work, we won't do the deal.
如果價值不起作用,我們將不做交易。
But of course, undeniably, the foreign companies as you've seen for most of the acquisitions that have occurred in the last year, foreign companies do have an advantage given their tax rate.
但是,當然,不可否認的是,正如您在去年發生的大多數收購中所看到的那樣,外國公司在稅率方面確實具有優勢。
And this is something that should be of concern to the US economy.
這是美國經濟應該關注的事情。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
I think the only thing I'd add, Ian, is, John, in your question you mentioned before we announced Wyeth, it was 22% and we took it up to 27%.
伊恩,我想我唯一要補充的是,約翰,在您在我們宣布惠氏之前提到的問題中,它是 22%,我們將其提高到 27%。
We actually took it up to 30%.
我們實際上把它提高到了 30%。
When we announced Wyeth, that we took the tax rate from 22% to 30%, and we've been I think in an effective way been able to step it down through a combination of changes in jurisdictional mix and tax planning.
當我們宣布惠氏公司時,我們將稅率從 22% 提高到 30%,我認為通過改變管轄組合和稅收計劃,我們能夠以一種有效的方式降低稅率。
We've gone from 30%, to 29%, to 28%.
我們已經從 30% 到 29% 再到 28%。
This past year, we had said approximately 27%, we printed 26.5% on adjusted results, and now we've guided for 2015 to approximately 25%.
過去一年,我們說大約 27%,我們在調整後的結果上打印了 26.5%,現在我們將 2015 年指導為大約 25%。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thank you.
謝謝你。
The next question, please, operator.
下一個問題,請接線員。
Operator
Operator
Your next question comes from David Risinger from Morgan Stanley.
您的下一個問題來自摩根士丹利的 David Risinger。
David Risinger - Analyst
David Risinger - Analyst
Thanks very much.
非常感謝。
I have two questions.
我有兩個問題。
Frank, in the context of a potential split up in the future, you've obviously set up the financials.
弗蘭克,在未來可能分拆的背景下,你顯然已經建立了財務狀況。
But could you please discuss the dis-synergies and the risk of pro forma total costs being higher due to step-up costs if a separation were pursued in the future?
但是,如果將來進行分離,您能否討論一下不協同效應以及由於逐步增加成本而導致的備考總成本更高的風險?
And then second, for Michael, could you please discuss the top three or four pipeline read-outs to watch in 2015?
其次,對於邁克爾,您能否討論一下 2015 年最值得關注的前三或四個管道讀數?
So specifically, what clinical trial read-outs are most important to focus on?
那麼具體來說,哪些臨床試驗讀數最值得關注?
Thank you.
謝謝你。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Please, Frank.
拜託了,弗蘭克。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
So, Dave, the way I think about the split question you asked me is in my mind they'll be basically three key determinants to obviously whether or not we would separate the Company.
所以,戴夫,我對你問我的分裂問題的看法是,在我看來,它們基本上是我們是否會分離公司的三個關鍵決定因素。
One is the performance of the businesses.
一是企業的業績。
The second one would be our confidence level in those businesses continuing to perform successfully on a standalone basis.
第二個是我們對那些繼續在獨立基礎上成功執行的業務的信心水平。
And then three would be how the market values those businesses, and quite frankly, is there an opportunity to create a tax efficient way incremental value.
然後三個是市場如何評價這些企業,坦率地說,是否有機會創造一種節稅的方式增加價值。
Is the sum of the parts greater than the whole?
部分之和是否大於整體?
Is there an ability to unlock that value?
是否有能力解鎖該價值?
That value part of the answer, in my mind, would factor in the items you raised like dis-synergies.
在我看來,答案的價值部分會考慮到你提出的項目,比如不協同效應。
That's all part of the value equation that we'd have to factor in to get to a net-net positive, along with the aforementioned standalone performance.
這都是我們必須考慮的價值方程式的一部分,以達到淨淨正值,以及上述的獨立表現。
Mikael Dolsten - President Worldwide Research & Development
Mikael Dolsten - President Worldwide Research & Development
Let me mention a couple of read-outs.
讓我提幾個讀數。
So obviously from palbociclib or Ibrance, we are excited to also get read-outs from our recurrent study, combining with fulvestrant that Albert spoke about.
很明顯,從 palbociclib 或 Ibrance 中,我們很高興能從我們的反复研究中獲得讀數,並結合 Albert 談到的氟維司群。
Avelumab, our partnership with Merck-Serono around ASCO will be the first time we start to share updated data sets.
Avelumab,我們與默克雪蘭諾圍繞 ASCO 的合作將是我們第一次開始共享更新的數據集。
And I think there will be opportunity also later to hear how combinations are progressing, and possibly late in the year that we'll also share some data on 4-1BB, our own trial that we're running in lymphoma.
而且我認為稍後還將有機會了解組合的進展情況,並且可能在今年晚些時候我們還將分享一些關於 4-1BB 的數據,這是我們自己在淋巴瘤中進行的試驗。
We also have read-outs in ulcerative colitis, middle of the year or so.
我們也有潰瘍性結腸炎的讀數,年中左右。
We have top line results from induction study with Xeljanz.
我們從 Xeljanz 的歸納研究中獲得了頂級結果。
And please remember, in Phase 2, Xeljanz had very strong induction data, among the best that has been really presented in this field.
請記住,在第 2 階段,Xeljanz 擁有非常強大的歸納數據,是該領域真正呈現的最好的數據之一。
And at the JPMorgan, I also shared very robust and really interesting data from our MAdCAM antibody in UC.
在摩根大通,我還分享了來自我們在加州大學的 MAdCAM 抗體的非常可靠且非常有趣的數據。
So you could really look up on UC as a space where we have multiple interesting data sets.
因此,您真的可以將 UC 視為我們擁有多個有趣數據集的空間。
More near term, you also have an opportunity to look at inotuzumab in ALL, which we'll have analysis for complete response or complete response with incomplete hematological recovery.
更近期,您還有機會研究 ALL 中的 inotuzumab,我們將對完全緩解或血液恢復不完全的完全緩解進行分析。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Next question, please, operator.
下一個問題,請接線員。
Operator
Operator
Your next question comes from Seamus Fernandez from Leerink.
您的下一個問題來自 Leerink 的 Seamus Fernandez。
Seamus Fernandez - Analyst
Seamus Fernandez - Analyst
Thanks very much for the questions.
非常感謝您的提問。
First off, maybe, Frank, can you just walk us through -- we have an increase spending coming in -- well maybe not increased spending, but good cost controls overall.
首先,也許,弗蘭克,你能不能告訴我們——我們有增加的支出——也許不是增加支出,但整體成本控制良好。
But is there more to achieve or be taken out of the business from here where you can be opportunistic as we head towards the potential loss of Lyrica and some incremental pressures?
但是,在我們面臨 Lyrica 的潛在損失和一些增量壓力的情況下,是否還有更多可以實現或退出業務的機會?
Or are we off an overall growth trajectory on the business, including the expense base as we think about 2015 plus?
或者我們是否偏離了業務的整體增長軌跡,包括我們對 2015 年及以上的開支基礎?
And then separately, as we think about the PCSK9 opportunity, I think there's been a real emphasis on the outcomes from Pfizer.
然後,當我們考慮 PCSK9 的機會時,我認為輝瑞公司的成果得到了真正的重視。
But Pfizer has also demonstrated an ability to succeed in the statin space without outcomes.
但輝瑞也展示了在他汀類藥物領域取得成功的能力,但沒有結果。
Just wondering, despite being third to market, how you would anticipate competing before perhaps outcomes are available?
只是想知道,儘管在市場上排名第三,但在獲得結果之前,您將如何預期競爭?
And could you be, as a third to market product, how would you expect to compete without outcomes versus other competitors who likely won't have outcomes data either?
作為市場產品的第三者,您是否希望在沒有結果的情況下與其他可能也沒有結果數據的競爭對手競爭?
Thanks.
謝謝。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Okay, Frank, on spending.
好的,弗蘭克,關於支出。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
So on spending, Seamus, I've said this before.
所以關於支出,Seamus,我以前說過。
Clearly, we're in the late innings in terms of cost reduction.
顯然,我們在降低成本方面處於後期階段。
There's still opportunity.
還是有機會的。
So I think there's always opportunities.
所以我認為機會總是存在的。
I think there continues to be opportunities in G&A, for example, continues to be opportunities with our portfolio as the portfolio ebbs and flows.
我認為 G&A 繼續存在機會,例如,隨著投資組合的潮起潮落,我們的投資組合繼續存在機會。
So there's clearly opportunities related to the portfolio.
因此,顯然存在與投資組合相關的機會。
And that said, it's hard.
這就是說,這很難。
Ian mentioned in his comments that we've taken out $5.5 billion in expenses and operating expenses over the last four years.
伊恩在他的評論中提到,我們在過去四年中已經支出了 55 億美元的費用和運營費用。
There's not another $5.5 billion, for example, to take.
例如,沒有其他 55 億美元可以拿走。
So it's getting harder.
所以越來越難了。
If you look at our results for 2014, I'll give you the full year numbers operationally.
如果您查看我們 2014 年的業績,我會給您提供全年運營數據。
COGS was up 2%, SI&A was down 2%, R&D was up 9%.
COGS 增長 2%,SI&A 下降 2%,R&D 增長 9%。
Clearly, that upward pressure on R&D we printed $7.2 billion in 2014, as an actual number we guided to $6.9 billion to $7.4 billion for 2015.
顯然,我們在 2014 年印製了 72 億美元的研發壓力,而我們將 2015 年的實際數字引導至 69 億至 74 億美元。
That includes the $300 million upfront for OPKO, but I think R&D, OPKO aside is going to be in the low $7 billions going forward.
這包括 OPKO 的 3 億美元預付款,但我認為除了研發之外,OPKO 未來將只有 70 億美元。
So that's good upward pressure in my mind in terms of the late stage portfolio progressing in a good way.
因此,就後期投資組合的良好發展而言,我認為這是一個很好的上行壓力。
So I think that's probably more than you need.
所以我認為這可能比你需要的要多。
But I think the short answer is, there's always opportunities, but we don't have the same opportunities that we had several years ago because the base -- we've done a much better job I think in managing the base.
但我認為簡短的回答是,總是有機會,但我們沒有幾年前的機會,因為基地 - 我認為我們在管理基地方面做得更好。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
I'd just add to Frank's comments.
我只想補充弗蘭克的評論。
That what we're looking at is a transition from dealing with some $26 billion of LOEs from 2010 through 2015, and the need to rationalize our cost base to one of being investing in the future growth.
我們正在研究的是從 2010 年到 2015 年處理約 260 億美元的 LOE 的過渡,以及合理化我們的成本基礎的需要,以投資於未來的增長。
Which I think is basically the most desirable state to be in, to have top line growth, and we're investing in our Phase 3 pipeline and our innovative products.
我認為這基本上是最理想的狀態,實現收入增長,我們正在投資我們的第 3 階段管道和我們的創新產品。
But this management team is very good at managing our P&L and our investment and where we invest.
但是這個管理團隊非常擅長管理我們的損益和投資以及我們投資的地方。
And are prepared to do what's necessary if business circumstances change on our expense base.
如果我們的費用基礎上的業務環境發生變化,並準備好做必要的事情。
With that, the other question was for Geno on PCSK9?
有了這個,另一個問題是關於 PCSK9 上的 Geno?
Geno Germano - President Global Innovative Pharma
Geno Germano - President Global Innovative Pharma
So, Seamus, just to respond, clearly Pfizer has a long history and heritage in the cardiovascular space.
因此,Seamus 只是回應一下,顯然輝瑞在心血管領域有著悠久的歷史和傳統。
And I think that we can leverage that knowledge and obviously the data from our clinical trials to determine the best approach to the marketplace.
我認為我們可以利用這些知識以及顯然來自我們臨床試驗的數據來確定進入市場的最佳方法。
Frankly, we really expect the PCSK9 market to emerge as a large and attractive market with the occurrence of the outcomes data and we're most focused on that.
坦率地說,我們真的希望 PCSK9 市場隨著結果數據的出現而成為一個大而有吸引力的市場,我們最關注這一點。
We've obviously put our best thinking forward in our protocol designs.
我們顯然已經在我們的協議設計中提出了我們最好的想法。
And should we have stronger data than the other companies in the cholesterol management arm, then we'll leverage that.
如果我們擁有比膽固醇管理部門的其他公司更強大的數據,那麼我們將利用它。
But at this point, we'll have to wait and see how the data turns out, and again, our focus is mainly on the outcomes trials.
但在這一點上,我們將不得不拭目以待,看看數據結果如何,而且我們的重點主要是結果試驗。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Geno.
謝謝,杰諾。
Next question, please.
下一個問題,請。
Operator
Operator
Your next question comes from Steve Scala from Cowen.
您的下一個問題來自 Cowen 的 Steve Scala。
Steve Scala - Analyst
Steve Scala - Analyst
Thank you.
謝謝你。
I have two questions.
我有兩個問題。
First for Frank.
首先是弗蘭克。
Is the $400 million in spend for a potential Company split in non-GAAP guidance, and what happens to this number in 2016?
潛在公司的 4 億美元支出是否在非 GAAP 指導下進行拆分,2016 年這個數字會發生什麼變化?
Is it the same?
是一樣的嗎?
Is it higher or is it lower?
是更高還是更低?
And then the second question is on palbociclib.
然後第二個問題是關於 palbociclib。
Has the FDA taken a look or do you expect it to take a look prior to April 13th at the Phase 3 trial which is under way?
FDA 是否看過,或者您是否希望它在 4 月 13 日之前在正在進行的 3 期試驗中看一下?
Thank you.
謝謝你。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Frank, do you want to talk about --
弗蘭克,你想談談——
Frank D'Amelio - CFO
Frank D'Amelio - CFO
Sure.
當然。
So on the $400 million, Steve, it's in GAAP, it's not in adjusted.
所以在 4 億美元上,史蒂夫,它是按公認會計原則計算的,而不是經過調整的。
We actually called that out in the release.
我們實際上在發布中提到了這一點。
It's in that bridge we give you all, that bridge is from adjusted EPS to GAAP EPS.
正是在我們為您提供的那座橋樑中,那座橋樑是從調整後的 EPS 到 GAAP EPS。
I think the bridge shows -- starts at the top, shows $2 to $2.10, and then we have three take aways from that.
我認為橋牌顯示——從頂部開始,顯示 2 美元到 2.10 美元,然後我們從中得到三個收穫。
There's purchase accounting adjustments of $0.41.
採購會計調整為 0.41 美元。
There's restructuring and implementation costs that has a range of $0.13 to $0.18, and then there's a business and legal entity alignment cost which is the $400 million you allude to which is $0.04.
重組和實施成本在 0.13 美元到 0.18 美元之間,然後是業務和法律實體調整成本,即您提到的 4 億美元,即 0.04 美元。
So that's the bridge from $2.10 to $2.20 to $1.37 to $1.52.
這就是從 2.10 美元到 2.20 美元到 1.37 美元到 1.52 美元的橋樑。
So in GAAP, not in adjusted.
所以在 GAAP 中,而不是在調整後。
And we give you a bridge that breaks out how we get from point A to point B.
我們為您提供了一座橋樑,打破了我們如何從 A 點到達 B 點。
In terms of 2016, quite frankly as we get towards the end of the year, early next year, we'll call that number out to you.
就 2016 年而言,坦率地說,隨著我們接近年底,明年初,我們會告訴你這個數字。
Because a lot of that depends on how we progress through the year, how the businesses perform.
因為這在很大程度上取決於我們全年的進展情況,以及業務的表現。
So that's something that we'll call out obviously later in this year or early in 2016.
因此,我們將在今年晚些時候或 2016 年初明確提出這一點。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Albert, on palbociclib, Ibrance.
阿爾伯特,關於 palbociclib,Ibrance。
Albert Bourla - President Oncology, Vaccines & Consumer
Albert Bourla - President Oncology, Vaccines & Consumer
For Ibrance, I don't want to speculate what the FDA would like to do.
對於 Ibrance,我不想推測 FDA 想做什麼。
But from a timing perspective, we don't expect to have the results of even an interim review of of Phase 3 before the PDUFA date.
但從時間的角度來看,我們不希望在 PDUFA 日期之前對第 3 階段進行中期審查的結果。
And as you know, we are already in late stage discussions for the label.
如你所知,我們已經處於標籤的後期討論階段。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Albert.
謝謝,阿爾伯特。
Next question, please, operator.
下一個問題,請接線員。
Operator
Operator
Your next question comes from Jeff Holford from Jefferies.
您的下一個問題來自 Jefferies 的 Jeff Holford。
Jeff Holford - Analyst
Jeff Holford - Analyst
Hello.
你好。
Thanks very much for taking my question.
非常感謝您提出我的問題。
First one is for Ian.
第一個是給伊恩的。
Which is just really, what do you think about business development where you use OUS cash on OUS targets as non-inversion just straight M&A type deals as a potential pragmatic way to deal with the tax situation on those overseas cash assets?
真的,您如何看待業務發展,您將 OUS 現金用於 OUS 目標作為非倒置直接併購類型交易作為處理這些海外現金資產稅收情況的潛在務實方式?
Do you see potential opportunities to do that?
您是否看到這樣做的潛在機會?
And then, just a few financial questions.
然後,只是幾個財務問題。
As you want to be able to allow investors to see the value in the two separate pieces, what do you think about giving midterm guidance on the two potential separate pieces for investors to help them reach that decision and how you reached that decision?
由於您希望能夠讓投資者看到這兩個獨立部分的價值,您如何看待為投資者提供兩個潛在獨立部分的中期指導以幫助他們做出決定以及您是如何做出決定的?
Do you think it's reasonable to assume that this is now the floor, 2015 is now the floor in Pfizer revenues and EPS going forward?
你認為這是合理的假設現在是底線,2015 年現在是輝瑞收入和每股收益的底線嗎?
And then lastly, are you happy that we just extrapolate this year's tax rate going forward, or are there any other factors that we should consider?
最後,您是否高興我們只是推斷今年的稅率,還是我們應該考慮其他任何因素?
Thank you.
謝謝你。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Okay.
好的。
I'll let Frank answer your modeling questions.
我會讓弗蘭克回答你的建模問題。
On the BD and using offshore cash for offshore deals, once again, it comes down to value, it comes down to the offshore deals often price in the fact that there's offshore cash.
在 BD 上,使用離岸現金進行離岸交易,再次歸結為價值,歸結為離岸交易通常以有離岸現金為代價。
So you have to look at the price tag on the deals and see if they make sense.
因此,您必須查看交易的價格標籤,看看它們是否有意義。
But certainly, conceptually, you have a point.
但可以肯定的是,從概念上講,你說得有道理。
But it just comes down to the quality of the asset and the deals you're trying to do.
但這僅取決於資產的質量和您嘗試進行的交易。
Frank, on the other question.
弗蘭克,關於另一個問題。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
So let me hit the -- Jeff, let me hit the extrapolation of the tax rate first.
所以讓我來談談——傑夫,讓我先來推斷稅率。
I think the way I'll answer your question is we stepped it down this year to approximately 25%.
我想我會回答你的問題的方式是我們今年將其降低到大約 25%。
That's down from 26.5% in 2014.
這比 2014 年的 26.5% 有所下降。
So a nice decrease.
所以一個不錯的下降。
And please note that when we reduce a rate like we're doing for 2015, our intent is that that rate's sustainable for the foreseeable future.
請注意,當我們像 2015 年那樣降低利率時,我們的意圖是該利率在可預見的未來是可持續的。
So that's how I'd answer your question.
所以我會這樣回答你的問題。
And in terms of trying to provide guidance beyond 2015 for tax rates, given all the uncertainty in the tax environment, I think that just wouldn't be a prudent thing to do.
在試圖為 2015 年以後的稅率提供指導方面,考慮到稅收環境的所有不確定性,我認為這不是一件謹慎的事情。
In terms of your question on BUs and providing midterm type of guidance, we continue -- I think we're getting more and more transparent I think relative to our business units.
關於您關於 BU 的問題和提供中期類型的指導,我們繼續 - 我認為相對於我們的業務部門,我認為我們變得越來越透明。
This year, we started providing very detailed income statement information.
今年,我們開始提供非常詳細的損益表信息。
Come 2015, we're going to start to provide -- we'll start to provide some balance sheet information.
到 2015 年,我們將開始提供——我們將開始提供一些資產負債表信息。
So we're providing more and more information that I think enables a lot of good extrapolation work.
所以我們提供了越來越多的信息,我認為這些信息可以進行很多很好的外推工作。
In terms of taking our guidance and peeling it down to another level, I think it's hard enough to provide annual guidance for the total Company.
就我們的指導並將其剝離到另一個層次而言,我認為為整個公司提供年度指導已經足夠困難了。
You then taking it and slicing by sub-ledger detail I think, it creates a level of complexity that I don't think we're inclined to do.
然後,您將其按子分類帳詳細信息進行切片,我認為它會產生一定程度的複雜性,我認為我們不會傾向於這樣做。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thank you.
謝謝你。
Next question, please, operator.
下一個問題,請接線員。
Operator
Operator
Next question comes from Marc Goodman from UBS.
下一個問題來自瑞銀的 Marc Goodman。
Marc Goodman - Analyst
Marc Goodman - Analyst
Good morning.
早上好。
First of all, can you give us an update on China?
首先,您能介紹一下中國的最新情況嗎?
How did it perform in the quarter, and how you're expecting it to perform in 2015?
它在本季度的表現如何,您預計它在 2015 年的表現如何?
Give us some trends there.
給我們一些趨勢。
Second, just update us on palbo overseas and what the timing is there.
其次,只需更新我們在海外的 palbo 以及那裡的時間安排。
And then on the MAdCAM, you did provide some data.
然後在 MAdCAM 上,您確實提供了一些數據。
And I was curious if you could comment on the dose response, and on why it will take so long to move into Phase 3?
我很好奇您是否可以評論劑量反應,以及為什麼進入第 3 階段需要這麼長時間?
I think you said you're going to move into Phase 3 in 2016, and then I think the Phase 2s were done.
我想你說過你將在 2016 年進入第 3 階段,然後我認為第 2 階段已經完成。
So I was curious about that.
所以我對此很好奇。
And then lastly, just on Lipitor over the counter, I know there was one study that remains before you can go back and talk to FDA.
最後,就在立普妥(Lipitor)的櫃檯上,我知道在你回去和 FDA 交談之前還有一項研究。
I was curious where we stand on that, and when you think you'll be talking to FDA again?
我很好奇我們對此的立場,你認為你什麼時候會再次與 FDA 交談?
Thanks.
謝謝。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Okay, let's try and put it together.
好吧,讓我們試著把它放在一起。
So if Albert can answer the palbo and the Lipitor question.
因此,如果 Albert 可以回答 palbo 和 Lipitor 的問題。
Albert Bourla - President Oncology, Vaccines & Consumer
Albert Bourla - President Oncology, Vaccines & Consumer
We have had discussions with the European regulatory authorities on the clinical data.
我們已經與歐洲監管機構就臨床數據進行了討論。
And it is our intention to file in the EU this year.
我們打算今年在歐盟提交申請。
The anticipated filing packets will build off of what was submitted to the FDA, but it's too early to provide more details on that.
預期的文件包將以提交給 FDA 的內容為基礎,但現在提供更多細節還為時過早。
Coming to Lipitor, you're right, the actual use trial was completed in December of 2014, and the results are expected in second quarter.
來到立普妥,你說得對,2014年12月完成了實際使用試用,預計第二季度會有結果。
So once we receive the results, then we will define our next steps in our efforts to bring an OTC version of Lipitor.
因此,一旦我們收到結果,我們將確定下一步努力推出 OTC 版本的立普妥。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Okay.
好的。
John, China.
約翰,中國。
John Young - President Established Pharma
John Young - President Established Pharma
So thanks for the question, Mark.
所以謝謝你的問題,馬克。
So we continue to perform strongly in China.
因此,我們繼續在中國表現強勁。
I'll comment on the GEP segment, which is the largest segment of our business in China.
我將評論 GEP 部門,這是我們在中國業務中最大的部門。
Overall for the quarter, we had growth of 13%.
總體而言,本季度我們實現了 13% 的增長。
Overall for the year, we saw growth of around about 18%.
總體而言,我們看到了約 18% 的增長。
We continue to see as we always do in emerging markets quarter to quarter fluctuation, but we continue to be very satisfied by our performance in China.
我們繼續像往常一樣看到新興市場的季度波動,但我們仍然對我們在中國的表現感到非常滿意。
Segments that are strong for us are particularly our cardiovascular franchise, with Lipitor and Norvasc performing strongly.
對我們來說表現強勁的細分市場尤其是我們的心血管專營權,立普妥和諾瓦斯表現強勁。
And also a very strong performance from our anti-infectives business.
我們的抗感染業務也有非常強勁的表現。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Thank you.
謝謝你。
MAdCAM.
MAdCAM。
Mikael Dolsten - President Worldwide Research & Development
Mikael Dolsten - President Worldwide Research & Development
Yes.
是的。
So thank you for noticing the very interesting dose response that we shared with you.
因此,感謝您注意到我們與您分享的非常有趣的劑量反應。
We do think it represents possibly through human biology that at the mid-doses, 22 to 75 milligrams, in that range, we possibly inhibit the autoimmune cells causing disease while at the higher doses, you may also start to interfere with regular T-cells that have a protective effect.
我們確實認為它可能通過人類生物學表明,在 22 至 75 毫克的中等劑量下,在該範圍內,我們可能會抑制引起疾病的自身免疫細胞,而在較高劑量下,您也可能開始乾擾常規 T 細胞有保護作用的。
So it is very important to have done a very thorough dose response that can allow you to select the optimal dose.
因此,進行非常徹底的劑量反應非常重要,可以讓您選擇最佳劑量。
And we think this may distinguish our opportunity, MAdCAM versus other endocrine antibodies that may not have been able to do such a thorough dose response and pick the sweet spot.
我們認為這可以區分我們的機會,MAdCAM 與其他可能無法進行如此徹底的劑量反應並選擇最佳位置的內分泌抗體。
And actually if you look at our remission data, they really perform well versus other published comparisons, although it's historical comparisons.
實際上,如果您查看我們的緩解數據,與其他已發布的比較相比,它們確實表現良好,儘管這是歷史比較。
Concerning the time lines, so we'll certainly see if we can accelerate this, but that relates to production of clinical trial manufacturing for a potential registration study, and also to really understand how to design a study where you could best develop a drug that has this really unique tolerability profile, both for induction and maintenance therapy and how it could play as an anchor drug across many IBD-like conditions.
關於時間線,所以我們當然會看看我們是否可以加快這一進程,但這與為潛在的註冊研究生產臨床試驗生產有關,並且還需要真正了解如何設計一項研究,以便最好地開發出一種藥物具有這種非常獨特的耐受性特徵,無論是誘導治療還是維持治療,以及它如何在許多 IBD 樣疾病中作為錨定藥物發揮作用。
So that's why we gave a little bit of extended time period, and we may be able to shorten that as we go forward.
所以這就是為什麼我們給出了一點延長的時間段,隨著我們的前進,我們也許可以縮短它。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thank you, Mikael.
謝謝你,米凱爾。
Operator, if we could take our last question, please.
接線員,請回答我們的最後一個問題。
Operator
Operator
Your final question comes from Alex Arfaei from BMO Capital.
您的最後一個問題來自 BMO Capital 的 Alex Arfaei。
Alex Arfaei - Analyst
Alex Arfaei - Analyst
Good morning.
早上好。
And I apologize if I ask redundant questions.
如果我提出多餘的問題,我深表歉意。
I got disconnected briefly.
我短暫地斷開了連接。
Ian, from your perspective, could you comment on the M&A landscape in general?
伊恩,從您的角度來看,您能否對併購的總體情況發表評論?
Based on your conversations with management teams, are you finding willing sellers out there and is it just a matter of price?
根據您與管理團隊的對話,您是否找到了願意的賣家,這只是價格問題嗎?
The follow-up for Frank, and just following up on your earlier comments, how should we think about your margins for the next couple years?
弗蘭克的後續行動,以及您之前評論的後續行動,我們應該如何看待您未來幾年的利潤?
You're losing some high margin products.
您正在失去一些高利潤產品。
You said most of the cost cutting is done, and you're investing in launches.
您說大部分成本削減已經完成,並且您正在投資發布。
So is it fair to expect somewhat stable or perhaps slightly declining margins going forward?
那麼預期未來的利潤率會保持穩定或略有下降是否公平?
Thank you.
謝謝你。
Ian Read - Chairman & CEO
Ian Read - Chairman & CEO
Alex, on the price, willing sellers, price always determines whether you have a willing seller or not, normally.
亞歷克斯,關於價格,願意的賣家,價格總是決定你是否有願意的賣家,通常。
It's just a matter of what value you want to transfer.
這只是你想要轉移什麼價值的問題。
What I would say is I think the starting point of the prices are somewhat buoyant, shall we say, given where the marketplace is.
我想說的是,考慮到市場的位置,我認為價格的起點有些上漲。
So that does give you some concern when you look at paying the type of prices there are premiums you need of what we see as high valuations to begin with.
因此,當您考慮支付的價格類型時,這確實讓您有些擔憂,因為我們認為一開始的高估值需要溢價。
So we are being disciplined in how we look at that.
因此,我們在如何看待這一點上受到紀律處分。
And then would you like to answer the margin question?
然後你想回答邊距問題嗎?
Frank D'Amelio - CFO
Frank D'Amelio - CFO
So, Alex, I think a very good question in terms of I'll call it the rhythm of the margins.
所以,亞歷克斯,我認為這是一個非常好的問題,我稱之為邊緣節奏。
There is some, I'll call it, some downward pressure on our operating margins.
我會稱之為,我們的營業利潤率存在一些下行壓力。
So we've got $3.5 billion in LOEs next year [in 2015], some high margin products clearly putting some downward pressure on the operating margins.
因此,我們明年 [2015 年] 的 LOE 為 35 億美元,一些高利潤率產品顯然給營業利潤率帶來了一些下行壓力。
We've given guidance where you can obviously go through the line items and compute the numbers.
我們提供了指導,您顯然可以在其中瀏覽訂單項併計算數字。
That said, all of that's factored into our EPS guidance.
也就是說,所有這些都納入了我們的每股收益指導。
And I want to reiterate what I said before.
我想重申我之前所說的話。
If you exclude foreign exchange in the OPKO transaction, the midpoint of our guidance for next year is roughly what we printed in 2014, despite that $3.5 billion in LOEs.
如果在 OPKO 交易中排除外匯,我們明年的指導中點大致是我們在 2014 年打印的,儘管 LOE 為 35 億美元。
So we'll continue to manage our cost structure, obviously the opportunities aren't what they used to be, but there is some slight downward pressure on our operating margins.
因此,我們將繼續管理我們的成本結構,顯然機會已不再是過去,但我們的營業利潤率存在一些輕微的下行壓力。
That is what it is.
就是這樣。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thank you, Frank.
謝謝你,弗蘭克。
And thank you everybody for your attention this morning on the call.
感謝大家今天早上對電話會議的關注。
Operator
Operator
Ladies and gentlemen, thank you for participating in today's fourth-quarter 2014 earnings conference call.
女士們,先生們,感謝您參加今天的 2014 年第四季度財報電話會議。
This concludes the conference.
會議到此結束。
You may now disconnect.
您現在可以斷開連接。