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Operator
Operator
Good day, everyone, and welcome to Pfizer's fourth-quarter 2013 earnings conference call.
大家好,歡迎參加輝瑞公司 2013 年第四季度財報電話會議。
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 2013 performance.
早上好,感謝您今天加入我們,回顧輝瑞公司 2013 年第四季度的業績。
I'm joined today by our Chairman and CEO Ian Read; Frank D'Amelio, our CFO; Albert Bourla, President of Vaccines, Oncology, and Consumer; Mikael Dolsten, President of Worldwide Research and Development; Geno Germano, President of Global Innovative Pharma; John Young, President of Established Pharma; and Doug Lankler, General Counsel.
今天,我們的董事長兼首席執行官 Ian Read 加入了我的行列;我們的首席財務官 Frank D'Amelio; Albert Bourla,疫苗、腫瘤學和消費者總裁; Mikael Dolsten,全球研發總裁; Geno Germano,全球創新製藥總裁;知名製藥公司總裁 John Young;和總法律顧問 Doug Lankler。
The 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 2013 which is located in the For Investors section in the lower right-hand corner of this page.
可以在我們的主頁 Pfizer.com 上查看本次電話會議上展示的幻燈片,方法是單擊位於本頁右下角的“面向投資者”部分的 2013 年第四季度輝瑞季度公司業績鏈接.
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。
Factors that could cause actual results to differ are discussed in Pfizer's 2012 annual report on Form 10-K and in our reports on Forms 10-Q and 8-K.
輝瑞 2012 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。
Discussion 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某些未根據公認會計原則準備的財務措施。
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 28, 2014.
輝瑞公司於 2014 年 1 月 28 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。
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 2013 with a solid fourth quarter and the overall financial performance of the year was strong.
我們以穩健的第四季度結束了 2013 年,全年的整體財務表現強勁。
Looking at the quarter, we delivered good operational performance.
縱觀本季度,我們提供了良好的運營業績。
Revenues and emerging markets grew 9%.
收入和新興市場增長了 9%。
Established products revenues grew 6%.
成熟產品收入增長 6%。
Oncology revenues grew 29%, and consumer health care grew 2%.
腫瘤學收入增長 29%,消費者醫療保健增長 2%。
We also had strong quarterly revenue performance operationally from key inline products such as Lyrica which grew 14%, Celebrex which grew 9%, and Enbrel outside of North America which grew 8%.
我們還從關鍵的在線產品中獲得了強勁的季度收入表現,例如增長 14% 的 Lyrica、增長 9% 的 Celebrex 和增長 8% 的北美以外的 Enbrel。
We continue to see positive progress with our recently launched products Eliquis and Xeljanz.
我們最近推出的產品 Eliquis 和 Xeljanz 繼續取得積極進展。
For Eliquis, in the last two quarters of 2013 we saw definitive momentum across key metrics resulting from the actions we implemented together with our partners BMS.
對於 Eliquis,在 2013 年最後兩個季度,我們與合作夥伴 BMS 一起實施的行動帶來了關鍵指標的明確勢頭。
While we are starting from a small base, the trend we are seeing on sales growth for Pfizer is significant.
雖然我們從一個小基數開始,但我們看到輝瑞的銷售增長趨勢是顯著的。
Specifically we saw a 124% increase in sales globally in the fourth quarter of 2013 compared to the third quarter, and TRx volume in the US for Eliquis increased 68% from the third to the fourth quarter of 2013.
具體來說,我們看到 2013 年第四季度的全球銷售額與第三季度相比增長了 124%,而 Eliquis 在美國的 TRx 銷量從 2013 年第三季度到第四季度增長了 68%。
For Xeljanz, we continue to see a steady increase in US scripts, over 28% growth in TRx volume in the fourth quarter compared to the third quarter of 2013.
對於 Xeljanz,我們繼續看到美國腳本的穩步增長,與 2013 年第三季度相比,第四季度的 TRx 數量增長了 28% 以上。
Physician feedback continues to be positive.
醫生的反饋仍然是積極的。
To date, nearly 3500 HCPs have prescribed Xeljanz and nearly 80% are repeat prescribers.
迄今為止,近 3500 名 HCP 已開具 Xeljanz 處方,近 80% 為重複處方者。
Now turning to highlights for the year.
現在轉向今年的亮點。
We met or exceeded every element of our financial guidance.
我們達到或超過了財務指導的每一個要素。
We drove operational growth in key products including Lyrica, Celebrex, and Enbrel outside of North America.
我們推動了北美以外主要產品的運營增長,包括 Lyrica、Celebrex 和 Enbrel。
Looking at how our businesses performed operationally, emerging markets reported solid single digit growth of 6%, oncology grew 29%, and consumer health business grew 5%.
從我們的業務運營表現來看,新興市場報告了 6% 的穩定個位數增長,腫瘤學增長了 29%,消費者健康業務增長了 5%。
We saw advancement in our pipeline across the portfolio.
我們看到整個投資組合的管道取得了進展。
We achieved approval in the US for Duavee for the treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of post menopausal osteoporosis.
我們在美國獲得了 Duavee 的批准,用於治療與絕經相關的中度至重度血管舒縮症狀和預防絕經後骨質疏鬆症。
We expect to launch next month and the FDA approved a prior approval supplement for Embeda extended release capsules.
我們預計將於下個月推出,FDA 批准了 Embeda 緩釋膠囊的事先批准補充。
We initiated a Phase 3 program which includes pivotal and outcome studies bococizumab, the proposed generic name for our PCSK9 monoclonal antibody to lower LDL cholesterol.
我們啟動了一項 3 期計劃,其中包括關鍵和結果研究 bococizumab,這是我們降低 LDL 膽固醇的 PCSK9 單克隆抗體的擬議通用名稱。
We initiated two Phase 3 studies with palbociclib in advanced breast cancer and began enrolling patients in a third Phase 3 study with a German breast group in patients with early breast cancer at a high risk of recurrence.
我們啟動了兩項 palbociclib 治療晚期乳腺癌的 3 期研究,並開始在德國乳腺組的第三項 3 期研究中招募患者,該研究是高複發風險的早期乳腺癌患者。
We initiated a Phase 3 program with our partner Merck for ertugliflozin, our SGL2 inhibitor for the treatment of Type 2 diabetes.
我們與合作夥伴默克公司啟動了 ertugliflozin 的 3 期計劃,ertugliflozin 是我們用於治療 2 型糖尿病的 SGL2 抑製劑。
We concluded a Phase 2 study for our staph aureus vaccine which showed encouraging signals that our vaccine elicits positive immune response.
我們完成了金黃色葡萄球菌疫苗的第二階段研究,該研究顯示出令人鼓舞的信號,表明我們的疫苗會引發積極的免疫反應。
We expect to present this data at a medical conference this year.
我們希望在今年的醫學會議上展示這些數據。
We completed a Phase 2A proof of concept study with a novel PDE5 inhibitor in diabetic neuropathy which showed an encouraging clinical profile warranting further exploration in Phase 2B.
我們用一種新型 PDE5 抑製劑在糖尿病性神經病變中完成了一項 2A 期概念驗證研究,該研究顯示出令人鼓舞的臨床特徵,值得在 2B 期進一步探索。
We conducted Phase 1 proof of concepts on biosimiliars of rituximab and infliximab which concluded with positive outcomes on the relevant study end points.
我們對利妥昔單抗和英夫利昔單抗的生物類似物進行了第一階段概念驗證,結果在相關研究終點取得了積極成果。
And for Xeljanz in Europe, where we received a negative opinion last year for our rheumatoid arthritis indication, we are continuing to pursue registration on actively engaging discussions with regulators and the development of additional data in support of refiling, although we continue to expect this result in a several year delay.
對於歐洲的 Xeljanz,我們去年收到了對類風濕性關節炎適應症的負面意見,我們將繼續尋求註冊,以積極參與與監管機構的討論並開發更多數據以支持重新申請,儘管我們繼續期待這一結果在幾年的延遲。
We reduced our total adjusted cost of sales, SI&A, and R&D expenses on an operational basis by approximately 3%, which is about an $850 million reduction versus 2012 levels.
我們在運營基礎上將調整後的總銷售成本、SI&A 和研發費用降低了約 3%,與 2012 年的水平相比減少了約 8.5 億美元。
We completed the separation of Zoetis and generated approximately $17.3 billion in after tax value.
我們完成了 Zoetis 的分離,並產生了大約 173 億美元的稅後價值。
We returned nearly $23 billion to shareholders in dividends and share repurchases and we put in place and are operating in our new commercial structure.
我們以股息和股票回購的形式向股東返還了近 230 億美元,我們實施並在新的商業結構中運營。
Each business has strong leadership in place, and we believe that by having a sharper focus we can better maximize the performance of all our businesses.
每個企業都有強大的領導力,我們相信,通過更加專注,我們可以更好地最大化我們所有業務的績效。
In terms of financial transparency, we will provide a management view of profit and loss for each business starting with the first-quarter results this year.
在財務透明度方面,我們將從今年第一季度的業績開始,提供每項業務的損益管理視圖。
To sum up the year, we strengthened our innovative core by advancing key R&D programs, created significant value for our shareholders with disciplined capital allocation, and our commercial businesses performed well during a time of transition and difficult market dynamics.
總結這一年,我們通過推進重點研發項目強化了創新核心,以嚴謹的資本配置為股東創造了重要價值,我們的商業業務在轉型時期和困難的市場動態中表現良好。
Three years ago we laid out the priorities and strategies for how we would create value for each of our businesses and address R&D productivity challenges.
三年前,我們就如何為每項業務創造價值和應對研發生產力挑戰制定了優先事項和戰略。
Over the course of the last three years our priorities and our strategies have not changed and I believe are showing strong results.
在過去三年中,我們的優先事項和戰略沒有改變,我相信正在顯示出強勁的成果。
Again in 2014, you can expect us to remain intensely focused on maximizing the opportunities within each of our commercial businesses, continue to advance science, innovation, and our pipeline, and prudently deploying our capital.
再次在 2014 年,您可以期待我們繼續專注於最大限度地利用我們每個商業業務中的機會,繼續推進科學、創新和我們的管道,並謹慎地部署我們的資本。
We see distinct opportunities for each of our commercial businesses this year.
今年,我們為每個商業業務都看到了獨特的機會。
The Global Innovative Pharma Business will focus on accelerating the uptake trajectory of newly launched products Xeljanz and Eliquis, and driving growth from major inline brands like Lyrica, Enbrel outside of North America, Viagra in the US, and Chantix.
全球創新製藥業務將專注於加速新推出的產品 Xeljanz 和 Eliquis 的吸收軌跡,並推動 Lyrica、北美以外的 Enbrel、美國的偉哥和 Chantix 等主要在線品牌的增長。
The Vaccines, Oncology and Consumer Healthcare Business, respectively, will capitalize on the Prevnar 13 franchise, concentrate on the recently launched oncology products Xalkori, Inlyta, and Bosulif, and launch over the counter Nexium in Europe and in the US, provided it receives FDA approval.
疫苗、腫瘤和消費者保健業務將分別利用 Prevnar 13 特許經營權,專注於最近推出的腫瘤產品 Xalkori、Inlyta 和 Bosulif,並在獲得 FDA 的情況下在歐洲和美國推出非處方 Nexium贊同。
The Global Established Pharma Business will focus on maximizing key [perielio] brands, namely Celebrex, Lyrica in the EU, and Zyvox.
全球成熟製藥業務將專注於最大化關鍵 [perielio] 品牌,即 Celebrex、歐盟的 Lyrica 和 Zyvox。
It will also support continued growth from important legacy off patented brands such as Lipitor and Norvasc in the emerging markets, build on local partnerships with those with Mylan, Teuto, and Hisun, and advance growth opportunities within the sterile injectables and biosimiliars portfolio.
它還將支持新興市場中立普妥和諾華士等重要專利品牌的持續增長,與邁蘭、Teuto 和 Hisun 建立本地合作夥伴關係,並在無菌注射劑和生物類似物產品組合中推進增長機會。
Building on the pipeline advances achieved in 2013, there are several potential milestones in 2014.
在 2013 年取得的管道進展的基礎上,2014 年有幾個潛在的里程碑。
We expect to report in the near future the top line results for Phase 2 study of palbociclib in patients with post menopausal ER positive advanced breast cancer.
我們希望在不久的將來報告 palbociclib 在絕經後 ER 陽性晚期乳腺癌患者中的二期研究的一線結果。
The results of the CAPiTA trial for Prevnar 13 in adults 65 and older are expected to read out during this quarter, and if supportive we expect to discuss the data with the Advisory Committee on Immunization Practices, ACIP, in the US and other regulatory authorities.
Prevnar 13 在 65 歲及以上成年人中的 CAPiTA 試驗結果預計將在本季度公佈,如果支持,我們預計將與美國免疫實踐諮詢委員會 (ACIP) 和其他監管機構討論數據。
Along with our partner Bristol-Myers Squibb, we are seeking approval for Eliquis, VTE prevention, in all VTE patients in the US and VTE treatment in the US and Europe.
與我們的合作夥伴 Bristol-Myers Squibb 一起,我們正在尋求批准 Eliquis 用於美國所有 VTE 患者的 VTE 預防以及美國和歐洲的 VTE 治療。
We have two pivotal trials in the Xeljanz Phase 3 oral psoriasis program that are anticipated to read out in the second quarter.
我們在 Xeljanz 3 期口腔銀屑病項目中進行了兩項關鍵試驗,預計將在第二季度公佈。
For the staph aureus and meningitis B vaccines, we anticipate sharing results from Phase 2 studies at medical congresses this year while advancing the late stage development of both assets.
對於金黃色葡萄球菌和乙型腦膜炎疫苗,我們預計今年將在醫學大會上分享二期研究的結果,同時推進這兩種資產的後期開發。
Last week we announced the top line Phase 3 results for ALO-02, an investigational agent of oxycodone hydrochloride, and naltrexone.
上週,我們公佈了 ALO-02(一種鹽酸羥考酮和納曲酮的研究藥物)的 3 期一線結果。
It met the primary efficacy endpoints in patients with moderate to severe chronic low back pain, demonstrating a statistical significance compared to placebo.
它在中度至重度慢性腰痛患者中達到了主要療效終點,與安慰劑相比具有統計學意義。
Yesterday we announced top line results for two Phase 3 studies, BR.26 and Archer 1009, that evaluated dacomitinib in two different populations of previously treated patients with advanced non-small cell lung cancer.
昨天,我們公佈了兩項 3 期研究 BR.26 和 Archer 1009 的一線結果,該研究評估了 dacomitinib 在兩個不同人群中接受過治療的晚期非小細胞肺癌患者的療效。
While we're disappointed that neither study met its primary end point, we will continue to evaluate the full data set from both trials to understand if molecularly defined subgroups of patients may derive benefit from dacomitinib.
雖然我們對兩項研究均未達到其主要終點感到失望,但我們將繼續評估兩項試驗的完整數據集,以了解分子定義的患者亞組是否可以從達克替尼中受益。
In order to continue to develop a robust pipeline of highly differentiated molecules and vaccines that have the potential to be first or best in class, such as the therapies I just noted, requires ongoing R&D investment.
為了繼續開發有潛力成為一流或同類最佳的高度差異化分子和疫苗的強大管道,例如我剛剛提到的療法,需要持續的研發投資。
In 2014 we will continue to be prudent stewards for how we allocate capital, and we will balance the need for incremental R&D investment with the need for delivering overall shareholder return.
2014 年,我們將繼續審慎地分配資金,在增加研發投資的需求與實現整體股東回報的需求之間取得平衡。
As we've done in the past, we will continue to use business development opportunities as an enabler of strategies to create value for our shareholders.
正如我們過去所做的那樣,我們將繼續利用業務發展機會作為戰略的推動者,為我們的股東創造價值。
In summary, we start 2014 with a sound strategy and a strong business.
總之,我們以穩健的戰略和強大的業務開啟 2014 年。
We will build on our performance in 2013 by continuing to create a sustainable high value pipeline and establishing strong commercial businesses.
我們將在 2013 年的業績基礎上繼續創造可持續的高價值管道並建立強大的商業業務。
By executing on our new product launches, growing key inline products, delivering on the potential at all phases of the pipeline, and effectively deploying our capital we will further strengthen all of our businesses.
通過執行我們的新產品發布、發展關鍵的內聯產品、在管道的所有階段發揮潛力以及有效地部署我們的資本,我們將進一步加強我們的所有業務。
Our top priority and commitment is to develop and to bring to patients innovative medicines that meet their needs, and that together with our actions, will generate and enhance shareholder value.
我們的首要任務和承諾是開發並為患者帶來滿足其需求的創新藥物,並且與我們的行動一起,將產生和提高股東價值。
Now I'll turn it over to Frank to take you through the details of the quarter and our financial guidance for 2014.
現在,我將把它交給弗蘭克,帶您了解本季度的詳細信息以及我們對 2014 年的財務指導。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
Thanks, Ian.
謝謝,伊恩。
Good day, everyone.
今天是個好日子。
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 are reported as a discontinued operation in the consolidated statements of income for full year 2013 and fourth quarter and full year 2012.
提醒大家,由於碩騰於2013年6月24日全部處置,動物保健業務的財務業績在2013年全年和第四季度合併利潤表中作為終止經營報告, 2012 年。
Now let's move on to the financials.
現在讓我們繼續討論財務。
Fourth-quarter 2013 reported revenues were approximately $13.6 billion, which decreased 2% year over year, and reflect operational growth of approximately 1% driven mainly by the strong performance of Lyrica, Celebrex, Inlyta, and Xalkori globally, Enbrel outside of North America, and Xeljanz and Eliquis primarily in the US.
2013 年第四季度報告的收入約為 136 億美元,同比下降 2%,反映出運營增長約 1%,這主要是由於全球 Lyrica、Celebrex、Inlyta 和 Xalkori 的強勁表現,北美以外的 Enbrel, Xeljanz 和 Eliquis 主要在美國。
These were more than offset by the unfavorable impact of foreign exchange of approximately $397 million, or 3%, the expiration on October 31, 2013 of the collaboration agreement for Enbrel in North America, continued erosion for branded Lipitor in developed Europe and certain other developed markets, the ongoing expiration of the Spiriva collaboration in certain countries, other product losses of exclusivity in certain markets, and decreased government purchases of Prevnar in certain emerging markets, among other items.
這些都被約 3.97 億美元或 3% 的外匯不利影響、Enbrel 在北美的合作協議於 2013 年 10 月 31 日到期、歐洲發達國家和某些其他發達國家品牌 Lipitor 的持續侵蝕所抵消。市場、Spiriva 合作在某些國家的持續到期、其他產品在某些市場的排他性喪失以及政府在某些新興市場對 Prevnar 的採購減少等。
Adjusted diluted EPS of $0.56 increased 22%, primarily due to the operational decrease of adjusted SI&A and R&D expenses, in increase in other income due primarily to the sale of a portion of our end-licensed generic sterile injectables portfolio to Mylan, a lower effective tax rate on adjusted income, and substantially fewer weighted average shares outstanding due to our continued share repurchases and the impact of the Zoetis exchange offer.
調整後的稀釋後每股收益為 0.56 美元,增長 22%,主要是由於調整後的 SI&A 和研發費用的運營減少,其他收入的增加主要是由於我們將部分最終許可的仿製藥無菌注射劑產品組合出售給 Mylan,這是一個較低的有效調整後收入的稅率,以及由於我們持續的股票回購和 Zoetis 交換要約的影響而顯著減少的加權平均流通股。
Reported diluted EPS was $0.39, compared with $0.85 in the year-ago quarter, driven by the significant negative impact of the nonrecurrence of income from discontinued operations attributable to the animal health and nutrition businesses, including the gain on the sale of the nutrition business in the year-ago quarter.
報告的攤薄每股收益為 0.39 美元,而去年同期為 0.85 美元,這是由於動物健康和營養業務導致的非經常性業務收入的重大負面影響,包括出售營養業務的收益去年同期。
In addition to the previously mentioned factors, reported diluted EPS was favorably impacted by a lower effective tax rate primarily due to favorable audit settlements, lower charges related to asset impairments and legal matters, and lower acquisition related expenses.
除了前面提到的因素外,報告的攤薄每股收益還受到有效稅率降低的有利影響,這主要是由於有利的審計結算、與資產減值和法律事務相關的費用降低以及與收購相關的費用降低。
During the fourth quarter, biopharmaceutical revenues in the BRIC-MT markets increased 6% operationally, driven primarily by strong volume growth in China, especially for Lipitor.
第四季度,金磚四國市場的生物製藥收入運營增長 6%,主要受中國銷量強勁增長的推動,尤其是立普妥。
In these BRIC-MT markets, volume growth of 6% was partially offset by foreign exchange of 3% versus the year-ago quarter.
在這些 BRIC-MT 市場中,6% 的交易量增長被與去年同期相比增長 3% 的外匯交易量部分抵消。
Revenue from all emerging markets increased 9% operationally in the fourth quarter, with China growing approximately 19% operationally.
第四季度來自所有新興市場的營業收入增長了 9%,其中中國的營業收入增長了約 19%。
If you exclude the portfolio of products whose rights were transferred to our joint venture in China with Hisun, in the fourth quarter we would have had operational revenue growth of 10% in our overall emerging markets business, 9% in the BRIC-MT markets, and 27% in China compared with the year-ago quarter.
如果排除權利轉讓給我們與海正在中國的合資企業的產品組合,第四季度我們的整體新興市場業務的營業收入將增長 10%,在金磚四國市場增長 9%,與去年同期相比,中國為 27%。
Foreign exchange negatively impacted fourth-quarter revenues by $397 million, or 3%, and positively impacted adjusted cost of sales, adjusted SI&A expenses, and adjusted R&D expenses in the aggregate by $251 million, or 3%.
外匯對第四季度的收入產生了 3.97 億美元或 3% 的負面影響,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 2.51 億美元或 3% 的積極影響。
As a result, foreign exchange negatively impacted fourth-quarter adjusted diluted EPS by approximately $0.01.
因此,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。
As you can see, in 2013 we met or exceeded all components of our financial guidance including exceeding our adjusted diluted EPS guidance.
如您所見,2013 年我們達到或超過了我們財務指導的所有組成部分,包括超過了我們調整後的稀釋每股收益指導。
Now I'd like to comment specifically on a few of the elements of our 2014 guidance.
現在我想特別評論一下我們 2014 年指南的一些要素。
First, we expect adjusted revenues to be in the range of $49.2 billion to $51.2 billion.
首先,我們預計調整後的收入將在 492 億美元至 512 億美元之間。
I want to point out that this range reflects an anticipated $3 billion negative impact due to declining alliance revenues specific to 2014, notably the Enbrel collaboration in North America and the ongoing expiration of the Spiriva collaboration in the US and other developed markets, and the loss exclusivity of certain products in several geographies, including Viagra in the EU, Japan, and Australia, Detrol in the US, and Aricept in major developed markets.
我想指出,由於 2014 年特定的聯盟收入下降,特別是 Enbrel 在北美的合作以及 Spiriva 在美國和其他發達市場的合作持續到期,以及損失某些產品在幾個地區的獨家經營權,包括歐盟、日本和澳大利亞的偉哥,美國的 Detrol 和主要發達市場的 Aricept。
I also want to point out that our 2014 adjusted revenue guidance also reflects an additional $1.4 billion negative impact due to the year-over-year difference in actual foreign exchange rates in mid-January of 2013 compared with mid-January of 2014, mainly driven by the movement of the yen against the US dollar.
我還想指出,由於 2013 年 1 月中旬與 2014 年 1 月中旬實際外匯匯率的同比差異,我們 2014 年調整後的收入指引也反映了額外的 14 億美元負面影響,主要驅動受日元對美元匯率的影響。
So had we applied the rates from mid-January of 2013 to our 2014 guidance, the adjusted revenue range would have been $1.4 billion higher.
因此,如果我們將 2013 年 1 月中旬的費率應用到 2014 年的指引中,調整後的收入範圍將增加 14 億美元。
We expect cost of sales as a percentage of revenue to be in the range of 19% to 20%, an increase from the 18% we recorded in 2013, driven by the significant decrease in alliance revenues.
我們預計銷售成本佔收入的百分比將在 19% 至 20% 之間,高於我們在 2013 年記錄的 18%,這是由於聯盟收入顯著下降。
It's important to remember that these alliance revenues were recorded at 100% gross margin because there's no associated cost of sales.
重要的是要記住,這些聯盟收入以 100% 的毛利率記錄,因為沒有相關的銷售成本。
Consequently, the significant decrease in these revenues will also negatively impact our cost of sales as a percentage of revenue in 2014.
因此,這些收入的顯著下降也將對我們 2014 年的銷售成本佔收入的百分比產生負面影響。
We expect adjusted SI&A expenses to be in the range of $13.5 billion to $14.5 billion, which reflects spending in support of key product launches as well as the benefit of our continued cost reduction and productivity initiatives.
我們預計調整後的 SI&A 費用將在 135 億美元至 145 億美元之間,這反映了支持關鍵產品發布的支出以及我們持續降低成本和提高生產力計劃的好處。
We expect adjusted R&D expenses to be in the range of $6.4 billion to $6.9 billion to support Phase 3 studies initiated in late 2013 and early 2014.
我們預計調整後的研發費用將在 64 億美元至 69 億美元之間,以支持 2013 年底和 2014 年初啟動的第三階段研究。
We also expect adjusted other deductions to be approximately $100 million.
我們還預計調整後的其他扣除額約為 1 億美元。
I want to remind everyone that the recognition of profits from the Enbrel collaboration in North America has shifted from alliance revenue to other income as we have moved to a royalty structure.
我想提醒大家,Enbrel 在北美合作的利潤確認已經從聯盟收入轉移到其他收入,因為我們已經轉向特許權使用費結構。
We expect our tax rate on adjusted income to be approximately 27%.
我們預計調整後收入的稅率約為 27%。
Finally, we expect adjusted diluted EPS to be in the range of $2.20 to $2.30.
最後,我們預計調整後的攤薄每股收益將在 2.20 美元至 2.30 美元之間。
This range includes anticipated share repurchases of approximately $5 billion this year, which will more than offset some expected dilution related to employee compensation programs.
這一範圍包括今年預計約 50 億美元的股票回購,這將足以抵消與員工薪酬計劃相關的一些預期稀釋。
It's important note that our 2014 adjusted diluted EPS guidance absorbs an $0.08 negative impact resulting from the previously mentioned difference and actual foreign exchange rates from mid-January 2013 compared with mid-January 2014.
值得注意的是,我們 2014 年調整後的稀釋後每股收益指引吸收了 0.08 美元的負面影響,該負面影響是由前面提到的 2013 年 1 月中旬與 2014 年 1 月中旬相比的差異和實際匯率造成的。
As always, we will continue to monitor foreign exchange fluctuations and we'll update the potential impact, if any, on our 2014 expectations.
與往常一樣,我們將繼續監控外匯波動,並更新對我們 2014 年預期的潛在影響(如有)。
So moving on to the key takeaways, we achieved or exceeded all elements of our full year 2013 financial guidance in a continuing challenging environment.
因此,繼續討論關鍵要點,在持續充滿挑戰的環境中,我們實現或超過了 2013 年全年財務指導的所有要素。
In 2013, we completed the separation of our animal health business and created a new commercial structure that we successfully implemented at the beginning of this year.
2013年,我們完成了動物保健業務的分離,並創建了新的商業架構,並於今年年初成功實施。
We provided full-year 2014 financial guidance, which reflects the negative impact of $3 billion due to declining alliance revenues and expected product losses of exclusivity.
我們提供了 2014 年全年財務指導,這反映了由於聯盟收入下降和預期的獨家產品損失造成的 30 億美元的負面影響。
In addition, our guidance for adjusted R&D expenses reflects our investment in several Phase 3 studies initiated in late 2013 and early 2014.
此外,我們對調整後研發費用的指導反映了我們對 2013 年底和 2014 年初啟動的幾項第三階段研究的投資。
We will continue to mitigate the impact of product losses of exclusivity and declining alliance revenue with growth from certain other products, as well as expense discipline and share repurchases.
我們將繼續通過某些其他產品的增長以及費用紀律和股票回購來減輕排他性產品損失和聯盟收入下降的影響。
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。
In 2013, we repurchased $16.3 billion, or 563 million shares.
2013 年,我們回購了 163 億美元,即 5.63 億股。
Overall in 2013, we returned almost $23 billion to shareholders through dividends and share repurchases.
總體而言,2013 年,我們通過股息和股票回購向股東返還了近 230 億美元。
Over the past three years we've returned almost $53 billion to shareholders through dividends and share repurchases.
在過去三年中,我們通過股息和股票回購向股東返還了近 530 億美元。
And in 2014, we expect to repurchase approximately $5 billion of our common stock.
2014 年,我們預計將回購大約 50 億美元的普通股。
Finally, we remain committed to delivering attractive shareholder returns in 2014 and beyond.
最後,我們仍然致力於在 2014 年及以後為股東提供有吸引力的回報。
With that, I'll turn it back to Chuck.
有了這個,我會把它轉回給查克。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Frank, and Ian, as well.
謝謝,弗蘭克和伊恩,也。
With that, Operator, if we could please poll for questions.
有了這個,操作員,如果我們可以請投票提問。
Operator
Operator
(Operator Instructions)
(操作員說明)
Your first question comes from Tim Anderson from Sanford Bernstein.
您的第一個問題來自 Sanford Bernstein 的 Tim Anderson。
Tim Anderson - Analyst
Tim Anderson - Analyst
Thank you.
謝謝你。
A couple of questions, please.
有幾個問題,請。
You've no doubt seen various analyst reports predicting what the financials for the three divisions will look like, and I know you're planning on providing those details on your Q1 call, but can you give us your preliminary thoughts on what you've seen thus far from the street?
毫無疑問,您已經看到各種分析師報告預測這三個部門的財務狀況,而且我知道您計劃在第一季度電話會議上提供這些詳細信息,但您能否就您的初步想法告訴我們看到這麼遠的街道?
Do you think we'll end up being surprised by how the numbers fall out between the different divisions or do you think the analyses you've seen look reasonable?
你認為我們最終會對不同部門之間的數字如何下降感到驚訝,或者你認為你看到的分析看起來合理嗎?
And then on palbociclib, any updated perspective on the likelihood of being able to file on the final Phase 2 results?
然後在 palbociclib 上,關於能夠提交最終第 2 階段結果的可能性的任何更新觀點?
I know that that day is approaching.
我知道那一天快到了。
I would imagine you've already had some discussions with the agency or at least at a minimum have some thoughts on the matter?
我想您已經與該機構進行了一些討論,或者至少對此事有一些想法?
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Okay.
好的。
Thank you, Tim.
謝謝你,蒂姆。
I'll ask Frank to answer the question that you posed on the financial divisions and when you'll see the results.
我會請弗蘭克回答您在財務部門提出的問題以及您何時能看到結果。
And then I would ask Albert Bourla to comment on palbo.
然後我會請 Albert Bourla 對 palbo 發表評論。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
So Tim, clearly we've looked at several models that have been put together relative to what the new businesses will look like.
所以蒂姆,很明顯我們已經研究了幾個模型,這些模型與新業務的外觀相關。
I think the rhythm of those numbers is directionally correct is how I would describe it, and obviously we'll come out with our own numbers for our first-quarter 2014 results.
我認為這些數字的節奏在方向上是正確的,正如我所描述的那樣,很明顯,我們將為 2014 年第一季度的業績提供我們自己的數字。
But I think directionally correct is how I would describe it.
但我認為方向正確是我將如何描述它。
I don't expect that what we publish will create any big surprises.
我不期望我們發布的內容會帶來任何大的驚喜。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Frank.
謝謝你,弗蘭克。
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Tim, on palbo, as you alluded our discussions with FDA are productive and they are ongoing, and this is particularly true given the breakthrough therapy designation we have received from them.
Tim,在 palbo 上,正如您提到我們與 FDA 的討論是富有成效的並且正在進行中,鑑於我們從他們那裡獲得的突破性治療指定,這一點尤其正確。
Now this discussion will continue after the Phase 2 analysis becomes available.
現在這個討論將在第 2 階段分析可用後繼續進行。
Therefore, the exact regulatory path forward has not yet been determined.
因此,具體的監管路徑尚未確定。
Now having said that, we can envision a scenario where depending upon the strength of the final Phase 2 data, there may be a pathway to file with the FDA based upon this Phase 3 results.
話雖如此,我們可以設想一個場景,根據最終的第 2 階段數據的強度,可能有一個基於第 3 階段結果的向 FDA 提交文件的途徑。
However, as you know, the acceptance of any filing is ultimately an FDA decision.
但是,如您所知,接受任何申請最終都是 FDA 的決定。
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。
Next question please, Operator.
下一個問題,接線員。
Operator
Operator
The next question comes from Gregg Gilbert from Bank of America.
下一個問題來自美國銀行的 Gregg Gilbert。
Gregg Gilbert - Analyst
Gregg Gilbert - Analyst
Thanks.
謝謝。
Just sticking with the palbo theme, could you comment on the competitive landscape in light of Novartis and Lilly's progress and what differentiation you could speak to at this early stage?
只是堅持 palbo 主題,您能否根據諾華和禮來的進展評論競爭格局,以及您在早期階段可以談論哪些差異化?
And for Frank, can you talk about -- can you put a little more meat on the bones on the gross margin commentary?
對於弗蘭克,你能談談 - 你能在毛利率評論中多加一點肉嗎?
What are the drivers for lower gross margin in 2014 and whether those items are trends or blips?
2014 年毛利率下降的驅動因素是什麼?這些項目是趨勢還是暫時現象?
Thank you.
謝謝你。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
So Albert, palbo again.
所以阿爾伯特,又是帕爾博。
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Yes, as you are aware there is very limited information in the public domain on these compounds from this company.
是的,正如您所知,公共領域中關於這家公司的這些化合物的信息非常有限。
So it's really difficult to differentiate palbo at this point until we see more clinical efficacy and safety data from them.
因此,在我們看到更多臨床療效和安全性數據之前,目前很難區分 palbo。
On palbo on the contrary, we have seen data and we are encouraged by the magnitude of the clinical activity we have seen in our patient population, so we are really looking forward to our final Phase 2 results.
相反,在 palbo 上,我們已經看到了數據,我們對我們在患者群體中看到的臨床活動的規模感到鼓舞,因此我們非常期待我們最終的第 2 階段結果。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you.
謝謝你。
Frank?
坦率?
Frank D'Amelio - CFO
Frank D'Amelio - CFO
Yes, so on the -- Gregg, on the gross margin, let me walk through this and I'm going to bridge this because I think it will be helpful.
是的,所以關於 - Gregg,關於毛利率,讓我介紹一下,我將彌補這一點,因為我認為這會有所幫助。
So let me run the numbers first.
所以讓我先計算一下數字。
We printed 18% for the full year 2013.
我們在 2013 年全年打印了 18%。
We're providing guidance for next year of 19% to 20%.
我們為明年提供 19% 至 20% 的指導。
So now let me build a bridge.
所以現在讓我建一座橋。
If we remove foreign exchange, the positive impact foreign exchange had last year on cost of sales, because it lowered cost of sales, that 18% becomes 18.5%.
如果我們去掉外匯,去年外匯對銷售成本的積極影響,因為它降低了銷售成本,原來的 18% 變成了 18.5%。
So 18% to 18.5%.
所以 18% 到 18.5%。
Then if you did the accounting for Enbrel in 2013, the way we're going to do the accounting for it in 2014, which is don't show it as alliance revenues but show it as royalties, that 18.5% would become 19%.
然後,如果您在 2013 年對 Enbrel 進行核算,我們將在 2014 年對其進行核算,即不將其顯示為聯盟收入,而是將其顯示為版稅,則 18.5% 將變為 19%。
So now 18% became 19%, and then that 19% to 20% in 2014 is really a result of the other alliance revenue declines, primarily Spiriva, and then some of the product LOEs.
所以現在 18% 變成了 19%,然後 2014 年的 19% 到 20% 實際上是其他聯盟收入下降的結果,主要是 Spiriva,然後是一些產品 LOE。
And one key point to make here is the big decline year in alliance revenues is in 2014, so that's the way to think about the rhythm of the numbers.
這裡要說明的一個關鍵點是聯盟收入大幅下降的一年是在 2014 年,所以這就是考慮數字節奏的方式。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thanks, Frank.
謝謝,弗蘭克。
Next question, please, Operator.
下一個問題,請接線員。
Operator
Operator
Your next question comes from Mark Schoenebaum from ISI Group.
您的下一個問題來自 ISI Group 的 Mark Schoenebaum。
Mark Schoenebaum - Analyst
Mark Schoenebaum - Analyst
Hello, guys.
大家好。
Thanks a lot for taking my question.
非常感謝您提出我的問題。
Also congratulations on a great P&L management in 2014.
也祝賀 2014 年的出色損益管理。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you.
謝謝你。
Mark Schoenebaum - Analyst
Mark Schoenebaum - Analyst
I know a lot of people were nervous about the alliance revenue lines and everything, so well done.
我知道很多人對聯盟的收入線和一切都感到緊張,做得很好。
I just want to ask a question that you probably get a lot but I thought I'd ask it on a call, and that is, is there a scenario that you can envision, Frank or Ian, where you might sell your established products unit or at least your generics unit in some kind of tax advantaged way prior to 2017?
我只是想問一個你可能會得到很多的問題,但我想我會在電話中問這個問題,也就是說,你是否可以設想一個場景,弗蘭克或伊恩,在那裡你可以出售你已建立的產品部門或者至少您的仿製藥部門在 2017 年之前以某種稅收優惠方式?
And then just the only other question I had if I might, is if my calculations are correct, R&D plus SG&A crept up a little bit as a percentage of revenue at the midpoint versus 2013, and I was just wondering I know you're not going to give guidance beyond 2014, but in general should -- are you comfortable with where our analyst models are, or should we expect that trend to continue or is that a 2014 blip?
如果可以的話,我唯一的另一個問題是,如果我的計算是正確的,與 2013 年相比,研發和 SG&A 在中點佔收入的百分比略有上升,我只是想知道我知道你不是將在 2014 年之後提供指導,但總的來說應該——你對我們的分析師模型的位置感到滿意,還是我們應該預期這種趨勢會繼續下去,還是 2014 年的曇花一現?
Thanks a lot.
非常感謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you.
謝謝你。
I think on the R&D, our R&D spend has been responsive to late Phase 3 assets that we have high confidence and want to invest in, and that's basically where the flex is.
我認為在研發方面,我們的研發支出一直在響應我們高度自信並希望投資的第三階段後期資產,而這基本上就是彈性所在。
I think we will fund where you would expect us to fund the Phase 3 assets to the extent we see great opportunity for them, and we'll continue to do that, but we'll continue to manage our overall P&L as we do that.
我認為,我們將在您希望我們為第三階段資產提供資金的地方提供資金,只要我們看到它們的巨大機會,我們將繼續這樣做,但我們將繼續管理我們的整體損益。
On the potential sale of our Established Products Business, we are managing all three businesses to create value for the Company, and I think the immediate focus of this is to get these businesses which have very strong management teams, which they have, to focus on the different ways of delivering value and to drive value for Pfizer shareholders.
關於我們已建立的產品業務的潛在出售,我們正在管理所有三個業務以為公司創造價值,我認為當前的重點是讓這些擁有非常強大的管理團隊的業務,他們擁有,專注於為輝瑞股東提供價值和推動價值的不同方式。
There are also several sort of data requirements which restrict our ability to enter into new transaction, even assuming if we wanted to at this stage, and I'll ask Frank to talk about that.
還有幾種數據要求限制了我們進入新交易的能力,即使我們在這個階段想要這樣做,我會請弗蘭克談談這個問題。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
Yes, so Mark, let me -- it's a lengthy answer, but let me try to work through this, which is it depends on the type of transaction.
是的,馬克,讓我——這是一個冗長的答案,但讓我試著解決這個問題,這取決於交易的類型。
So if it's a public transaction, so what's a public transaction?
那麼如果是公開交易,那麼什麼是公開交易呢?
A partial spin, a complete spin, a reverse Morris Trust, a partial IPO, a partial IPO followed by a spin or a split.
部分旋轉、完全旋轉、反向莫里斯信託、部分 IPO、部分 IPO 後旋轉或拆分。
Three years of audited financials are required.
需要三年的經審計財務。
That's a requirement.
這是一個要求。
If it's a private transaction, a partial sale of the business, a complete sale of the business, the formation of a joint venture where we have a minority interest or where we have a majority interest, no audited financials are required.
如果是私人交易、部分出售業務、完全出售業務、組建我們擁有少數股權或擁有多數股權的合資企業,則不需要經審計的財務。
However, a significance test is required.
但是,需要進行顯著性檢驗。
The results of which may require audited financials.
其結果可能需要經審計的財務。
Let me rip through the significance test.
讓我通過顯著性檢驗。
There's three tests that make up the significance test, there's an asset test, an income test, and an investment test.
顯著性檢驗由三個檢驗組成,資產檢驗、收入檢驗和投資檢驗。
And basically it's the target's results for each of those tests as a percentage of the acquirer's results.
基本上它是每個測試的目標結果占收購者結果的百分比。
So think about income would be the target's income as a percentage of the acquirer's income.
因此,考慮收入將是目標收入佔收購方收入的百分比。
Now the way the results work or the tests work is if all three tests are less than 20%, no audited financials are required.
現在,結果或測試的工作方式是,如果所有三個測試都低於 20%,則不需要經過審計的財務。
If any one test is greater than 20% and lower than 40%, between 20% and 40%, one year of audited financials is required.
如果任何一項測試大於 20% 且低於 40%,介於 20% 和 40% 之間,則需要一年的經審計財務。
Between 40% and 50%, any one test, two years of audited financials, and any one test greater than 50%, two years of audited balance sheets, three years of audited P&Ls, cash flows, other comprehensive income, and shareholders equity statements, so that's basically what's required and why it's required.
40% 和 50% 之間,任何一項測試,兩年的經審計財務,以及任何一項大於 50% 的測試,兩年經審計的資產負債表,三年經審計的損益表,現金流量,其他綜合收益和股東權益報表,所以這基本上是需要的以及為什麼需要它。
That's the summary.
這就是總結。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Frank.
謝謝你,弗蘭克。
As you can see, Mark, we have thought some, a lot about this issue, and I would say that the -- we want to create optionality and the best way to create optionality is having strong results and transparency on these results over the next few years and that's what we're focused on.
正如你所看到的,馬克,我們已經對這個問題進行了很多思考,我想說——我們想要創建可選性,創建可選性的最佳方式是在接下來的這些結果中獲得強大的結果和透明度幾年,這就是我們所關注的。
Mark Schoenebaum - Analyst
Mark Schoenebaum - Analyst
Thank you.
謝謝你。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Ian, and thanks, Frank, for the detail there.
謝謝伊恩,謝謝弗蘭克那裡的細節。
Next question, Operator.
下一個問題,接線員。
Operator
Operator
Your next question comes from Jami Rubin from Goldman Sachs.
您的下一個問題來自高盛的 Jami Rubin。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you.
謝謝你。
Just to follow up on that, Ian, if you could talk about the value business, which is what I think we're all focused on here, the Emerging Markets and Established Products Business, that's a huge part of the overall Pfizer story.
緊接著,伊恩,如果你能談談價值業務,我認為這是我們在這裡都關注的,新興市場和成熟產品業務,這是輝瑞整個故事的重要組成部分。
And while we appreciate that you are going to focus on driving value of each of these businesses, maybe you could talk about how you think about the margin and growth potential of this business, what are the true durable earnings performance that you see from this business?
雖然我們很欣賞您將專注於推動這些業務中的每一項的價值,但也許您可以談談您如何看待該業務的利潤率和增長潛力,您從該業務中看到的真正持久的盈利表現是什麼?
Because from what we see, the growth of Established Products is really just coming from shifting products that go generic into that business, and then the Emerging Markets piece is obviously very difficult to predict.
因為從我們所看到的情況來看,成熟產品的增長實際上只是來自將通用產品轉移到該業務中,然後新興市場部分顯然很難預測。
So maybe if you can sort of provide your view on how you see this business as a standalone performing over the next three years or so?
因此,也許您可以就您如何看待該業務在未來三年左右的獨立表現提供您的看法?
And then just as a follow up to the breakup scenario, Frank.
然後就像分手場景的後續行動,弗蘭克。
You said three years of financial audited information is required.
你說需要三年的財務審計信息。
So if we're starting to get the data in the first quarter of this year, does that then mean that the earliest you could contemplate a full break up would be end of 2016?
因此,如果我們在今年第一季度開始獲得數據,這是否意味著您最早可以考慮徹底分手是在 2016 年底?
Thanks.
謝謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Jami.
謝謝你,傑米。
Well, obviously, as I said, the Established Products Business is not a homogeneous business, it's a heterogeneous business with many different opportunities.
好吧,顯然,正如我所說,成熟產品業務不是同質業務,而是具有許多不同機會的異質業務。
And we have a very strong management in all our teams, so I'm going to ask John Young to answer your good questions, though, on how we will manage the Established Business for growth.
我們在所有團隊中都有非常強大的管理人員,所以我將請 John Young 回答您的好問題,不過,關於我們將如何管理已建立的業務以實現增長。
And on the last point, I think, yes, we're indicating that we would have three years of financials by the end of 2016.
最後一點,我認為,是的,我們表示到 2016 年底我們將擁有三年的財務狀況。
John Young - President of Global Established Pharma
John Young - President of Global Established Pharma
Okay.
好的。
So thanks for the question, Jami, so maybe just to say a little bit about what this business is.
謝謝你的問題,Jami,所以也許只是想談談這項業務是什麼。
I think, certainly, we believe that this is not only a very large business unit to your point about its contribution to Pfizer overall, but actually a very attractive, a very diverse, and a very profitable business with actually some unique opportunities across different portfolios and geographies.
我認為,當然,我們相信這不僅是一個非常大的業務部門,就您對輝瑞的整體貢獻而言,它實際上是一個非常有吸引力、非常多樣化和非常有利可圖的業務,在不同的投資組合中實際上有一些獨特的機會和地理。
So let me just walk you through a little bit of what this business really comprises.
因此,讓我帶您了解一下這項業務的真正組成部分。
And broadly, we think of it as in four buckets.
從廣義上講,我們認為它分為四個桶。
There is a peri-LOE business in developed markets that include some of the major brands that currently are pre-LOE, such as Celebrex, Zyvox, Lyrica in the EU.
在發達市場有一個 peri-LOE 業務,其中包括一些目前處於 LOE 之前的主要品牌,例如歐盟的 Celebrex、Zyvox、Lyrica。
Certainly, we're going to be very focused in that segment on maximizing the profitability of those brands.
當然,我們將非常專注於該領域,以最大限度地提高這些品牌的盈利能力。
Both sides of the LOE spectrum in leveraging some the capability from EP, that we think has really done a pretty good job with some of the recent LOEs, such as Lipitor, compared to market proxies.
LOE 頻譜的雙方都利用了 EP 的一些功能,與市場代理相比,我們認為在最近的一些 LOE(例如立普妥)方面確實做得很好。
The second segment of the business is really a legacy EP business that comprises mature off patent products in developed markets.
該業務的第二部分實際上是傳統的 EP 業務,包括發達市場的成熟非專利產品。
That business is declining, but we're very focused on maximizing profitability through target investments and certain brands in that portfolio that present opportunities for growth.
該業務正在下滑,但我們非常專注於通過目標投資和該投資組合中的某些品牌來最大化盈利能力,從而帶來增長機會。
The third piece of the business is really what comprises probably a little more than 70% of the emerging market today.
第三部分業務實際上佔當今新興市場的 70% 以上。
And that business is growing pretty strongly.
而且該業務正在強勁增長。
You've seen our results from the fourth quarter for the Emerging Market Business overall.
您已經看到了我們第四季度對新興市場業務的整體業績。
We believe that portfolio, and actually the thick of the mature products and the Global Established Pharma report portfolios, is a great fit actually for a lot of the health care needs that we see in some of the key emerging markets such as China and Brazil and Mexico.
我們認為,該產品組合,實際上是成熟產品和全球成熟製藥公司報告的產品組合,非常適合我們在中國和巴西等一些主要新興市場看到的許多醫療保健需求,以及墨西哥。
That is growing today and we envision that that will continue to grow in the future.
這在今天正在增長,我們預計未來將繼續增長。
And then the last component of this business really is what we think of as growth opportunities.
然後這項業務的最後一個組成部分確實是我們認為的增長機會。
Now, some of those growth opportunities will be medium-term growth opportunities, such as the biosimilar portfolio.
現在,其中一些增長機會將是中期增長機會,例如生物仿製藥產品組合。
We think we have one of the leading biosimilar portfolios in the industry with five assets in different stages of development.
我們認為我們擁有業內領先的生物仿製藥產品組合之一,有五種資產處於不同的發展階段。
But we actually have a number of other opportunities, too, through areas of growth such as some of the partnerships that you're already aware of with Teuto, Hisun, Mylan, all of which we're very pleased with and performing well.
但實際上,我們也有許多其他機會,通過增長領域,例如您已經知道的與 Teuto、Hisun、Mylan 的一些合作夥伴關係,所有這些我們都非常滿意並且表現良好。
And we're going to be very active in looking for additional partnerships in targeted markets where we think there's an opportunity to add shareholder value.
我們將非常積極地在我們認為有機會增加股東價值的目標市場中尋找更多的合作夥伴關係。
Opportunities for continued growth for sterile injectables and some targeted opportunities in certain markets for some reformulated branded generic products, as well.
無菌注射劑的持續增長機會以及某些重新配製的品牌仿製藥產品在某些市場上的一些目標機會。
I think probably the last point to make is this is really not a commodity generic business.
我認為最後一點可能是這真的不是商品通用業務。
In fact, less than 10% of our revenues would come from what you traditionally think of as being a generic business.
事實上,我們不到 10% 的收入來自您傳統上認為的通用業務。
So it is no doubt that we will see some pressure in revenues over the next few years driven by some the LOEs that everyone is well aware of from some of those big peri-LOE brands.
因此,毫無疑問,我們將在未來幾年看到一些 LOE 推動的收入壓力,這些 LOE 是每個人都非常清楚的一些大型 peri-LOE 品牌。
But actually, this is a business where we believe in the medium term that it will plateau and we believe that we can then have a number of significant opportunities for growth with this business in medium to longer term.
但實際上,這是一項我們相信在中期內它將趨於平穩的業務,我們相信我們可以在中長期內通過這項業務獲得許多重要的增長機會。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, John.
謝謝你,約翰。
Frank, you want to make a comment?
弗蘭克,你想發表評論嗎?
Frank D'Amelio - CFO
Frank D'Amelio - CFO
Just real quickly, Jami, just want to punctuate what Ian said which is three years prospective financials as I've said previously.
真的很快,Jami,只是想強調一下 Ian 所說的,正如我之前所說的那樣,這是三年的預期財務狀況。
So that would be 2014, 2015, and 2016 financials.
這將是 2014 年、2015 年和 2016 年的財務狀況。
And then, obviously, the 2016 10-K wouldn't be done until the end of February of 2017.
然後,很明顯,2016 年 10-K 直到 2017 年 2 月底才會完成。
So actual optionality, if we decided to do so, would be sometime in 2017.
因此,如果我們決定這樣做,實際的可選性將在 2017 年的某個時候。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Frank.
謝謝,弗蘭克。
Operator, next question please.
接線員,請下一個問題。
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, thanks very much.
太好了,非常感謝。
Just staying on the Established Products side, I recognize the near term focus in that business unit is working on the performance, but when you consider the long-term options for that business, first of all would you agree with the statement that this is the division where a larger merger could make the most sense for Pfizer?
只是停留在已建立的產品方面,我認識到該業務部門的近期重點是績效,但是當您考慮該業務的長期選擇時,首先您是否同意這樣的說法對輝瑞來說,更大規模的合併在哪裡最有意義?
And following onto that, can you walk through the pros and cons of a larger merger for that division as you consider your options relative to either running the business on your own or looking at tuck in deals?
在此之後,當您考慮與自己經營業務或尋找交易相關的選擇時,您能否了解該部門更大合併的利弊?
And then my second question is just as we're thinking about capital deployment, is there any changes in the way you're thinking about share repo versus higher dividend payout or other opportunities in light of the new business structure?
然後我的第二個問題是,正如我們正在考慮資本配置一樣,鑑於新的業務結構,您考慮股票回購與更高的股息支付或其他機會的方式是否有任何變化?
Does that change at all of just that you want to either have more cash available as these business units look at their various options as you consider new structures, et cetera, just anything we should be thinking of there?
這是否會改變只是因為您希望擁有更多可用現金,因為這些業務部門會在您考慮新結構等時考慮他們的各種選擇,等等,以及我們應該在那裡考慮的任何事情?
Thanks very much.
非常感謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
So Chris, I think on the Established Products Business our focus is the creation of value, so we do have a quite impressive portfolio and a geographic presence across the emerging markets and your question is will further scale be useful.
所以克里斯,我認為在已建立的產品業務上,我們的重點是創造價值,因此我們確實擁有令人印象深刻的產品組合和在新興市場的地理分佈,您的問題是進一步擴大規模是否有用。
I think it depends very much on the opportunities that arrive and we'd have to be opportunistic about that.
我認為這在很大程度上取決於即將到來的機會,我們必須對此保持機會主義。
Clearly, if we can add broader portfolio and specific scale in specific countries would be interested in it, which is why we'd be doing our JVs on a country by country basis, and would be open to overall alternatives, as we always are, that will create shareholder value.
顯然,如果我們可以在特定國家增加更廣泛的產品組合和特定規模,我們會對此感興趣,這就是為什麼我們會在一個國家一個國家的基礎上開展我們的合資企業,並且會像往常一樣對整體替代方案持開放態度,這將創造股東價值。
But prior to that, we're going to focus right now on running that business, producing the value, and an open to various BD alternatives to create more value.
但在此之前,我們現在將專注於運營該業務,創造價值,並對各種 BD 替代品持開放態度,以創造更多價值。
On the second question, on the capital structure, I think as we've seen in the last three years, our capital structure and the way we manage our capital has been focused on ensuring we produce the best return for our shareholders.
關於第二個問題,關於資本結構,我認為正如我們在過去三年中看到的那樣,我們的資本結構和我們管理資本的方式一直專注於確保我們為股東創造最佳回報。
We continue to manage that mix, and I would ask Frank to make some more specific comments.
我們將繼續管理這種組合,我會請弗蘭克發表一些更具體的評論。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
And Chris, I think the short answer is our priorities have not changed.
克里斯,我認為簡短的回答是我們的優先事項沒有改變。
Maybe I'll embellish a little bit.
也許我會稍微修飾一下。
So clearly, on dividends, buybacks continue to remain important parts of our capital allocation.
很明顯,在股息方面,回購仍然是我們資本配置的重要組成部分。
Investing in the business, you see that in 2014 with our capital deployment for R&D, for launch costs in support of our new products.
投資業務,您會看到 2014 年我們的研發資本部署,用於支持我們的新產品的啟動成本。
Obviously business development remains a priority.
顯然,業務發展仍然是重中之重。
So priorities haven't changed.
所以優先級沒有改變。
And you look at what we did can with our dividend in December, we increased the dividend from $0.96 to $1.04, an 8.3% increase.
你看看我們在 12 月份對股息做了什麼,我們將股息從 0.96 美元增加到 1.04 美元,增長了 8.3%。
We just announced another $5 billion in repurchases of our shares.
我們剛剛宣布再回購 50 億美元的股票。
So the priorities have not changed, they remain the same.
所以優先級沒有改變,它們保持不變。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
I would just add to Frank's comment there, is I think we see ourselves in a position of well balance with optionality and many directions given our capital structure.
我只想補充弗蘭克的評論,我認為我們認為自己在考慮到我們的資本結構的情況下,可以很好地平衡可選性和許多方向。
Thank you, Frank.
謝謝你,弗蘭克。
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 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, two questions.
謝謝,兩個問題。
First, I believe there is a pending court discussion, so does your 2014 guidance bracket a scenario where generics to Celebrex launch in May of this year, or do the guidance elements not consider the scenario?
首先,我相信有一個懸而未決的法庭討論,那麼你們 2014 年的指導是否涵蓋了 Celebrex 仿製藥在今年 5 月推出的情景,或者指導要素是否沒有考慮這種情景?
And the second question is I know FDA was aware of CAPiTA's design very early on, but what discussions have you had with ACIP on the design of CAPiTA and are they comfortable that it did not compare Prevnar to Pneumovax?
第二個問題是我知道 FDA 很早就知道 CAPiTA 的設計,但是您與 ACIP 就 CAPiTA 的設計進行了哪些討論,他們是否對它沒有將 Prevnar 與 Pneumovax 進行比較感到滿意?
Thank you very much.
非常感謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
So Doug, do you want to comment on the Celebrex situation?
所以道格,你想評論一下西樂葆的情況嗎?
Doug Lankler - General Counsel
Doug Lankler - General Counsel
Sure.
當然。
Obviously, so we have our reissued patent on Celebrex that takes us through December 2, 2015, and our trial to defend that patent is scheduled to commence on March 19 of this year.
顯然,因此我們在 Celebrex 上重新頒發了專利,該專利將我們帶到 2015 年 12 月 2 日,我們為該專利辯護的審判定於今年 3 月 19 日開始。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Frank, you want to add anything to that?
弗蘭克,你想補充什麼嗎?
Frank D'Amelio - CFO
Frank D'Amelio - CFO
Yes.
是的。
That our guidance assumes we have a full year of Celebrex.
我們的指導假設我們有一整年的 Celebrex。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you.
謝謝你。
Albert, on discussions of ACIP?
阿爾伯特,關於 ACIP 的討論?
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Yes, as you can imagine, one is we have the results.
是的,正如你可以想像的那樣,一個是我們有結果。
We will determine the best approach to present the data to ACIP and request a recommendation.
我們將確定向 ACIP 提供數據的最佳方法並請求推薦。
We have been in discussions with the CDC and members of ACIP to ensure their understanding of the protocol and the potential outcomes, so when they have the data they can move quickly.
我們一直在與 CDC 和 ACIP 成員進行討論,以確保他們了解協議和潛在結果,因此當他們擁有數據時,他們可以迅速採取行動。
The ACIP meets three times per year.
ACIP 每年開會 3 次。
I cannot speculate in which meeting they will make a vote.
我無法推測他們將在哪個會議上投票。
As regards your question for how would they compare it with Pneumovax, again I cannot speculate on that, but if you look at current practice in immuno-compromised adults, age 19 years and older where there is recommendation, ACIP has recommended routine use of Prevnar 13 administered in addition to Pneumovax.
至於您關於他們如何將其與 Pneumovax 進行比較的問題,我再次無法推測,但如果您查看目前有建議的 19 歲及以上免疫受損成年人的實踐,ACIP 建議常規使用 Prevnar除了 Pneumovax 外,還有 13 次給藥。
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
Excellent.
出色的。
Next question please, Operator.
下一個問題,接線員。
Operator
Operator
Our next question comes from Alex Arfaei from BMO Capital Markets.
我們的下一個問題來自 BMO Capital Markets 的 Alex Arfaei。
Alex Arfaei - Analyst
Alex Arfaei - Analyst
Good morning, thank you for taking the questions and congratulations on the performance.
早上好,感謝您提出問題並祝賀您的表現。
I was wondering if you could provide us more color on the powering assumptions for capital and do you believe there's still enough residual disease among US adults given that Prevnar 13 has been available for four years and there is probably significant herd effect?
我想知道您是否可以為我們提供更多關於資本的動力假設的顏色,並且鑑於 Prevnar 13 已經上市四年並且可能存在顯著的羊群效應,您是否認為美國成年人中仍有足夠的殘留疾病?
And finally on palbo, is the Phase 2 sufficiently powered to detect a significant difference, statistically significant survival difference, between the two arms?
最後在 palbo 上,Phase 2 是否足夠強大,可以檢測到兩個臂之間的顯著差異、統計學上顯著的生存差異?
Thank you.
謝謝你。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you for that question.
謝謝你的問題。
I believe the CAPiTA design was powered for three end points, and would have been designed well aware of the herd effect, so I'd ask Albert just to talk through the three end points of CAPiTA.
我相信 CAPiTA 設計是為三個端點提供動力的,並且在設計時會很好地意識到羊群效應,所以我想請 Albert 談談 CAPiTA 的三個端點。
And really the response of ACIP will depend on those end points and that's why we have to wait for the trial to read out.
實際上,ACIP 的響應將取決於這些終點,這就是為什麼我們必須等待審判宣讀的原因。
But I believe it was a very well designed trial.
但我相信這是一次精心設計的試驗。
Power to achieve, to show the results if the product performs as we expect.
實現的力量,如果產品按我們預期的方式運行,則展示結果。
And then on the Phase 2, Albert, could you discuss the powering vis-a-vis overall survival?
然後在第 2 階段,Albert,您能否討論一下供電與整體生存的關係?
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Yes, well, as we said CAPiTA is a large complex trial.
是的,正如我們所說,CAPiTA 是一項大型複雜試驗。
We have 85,000 healthy volunteers and the three end points are a primary end point to demonstrate the efficacy of the product and prevention of first episode of pneumococcal cap community, I call it pneumonia of course for vaccine type.
我們有 85,000 名健康志願者,三個終點是證明產品功效和預防首發肺炎球菌群落的主要終點,疫苗類型我當然稱之為肺炎。
And the secondary points of this to demonstrate the same efficacy in the first episode on non-bacterimic, non-invasive CAP and in invasive pneumococcal disease.
第二點是在非細菌性、非侵入性 CAP 和侵襲性肺炎球菌疾病的第一集中證明了相同的療效。
And as we said, the study is very well designed, taking into consideration everything about study was post registration, proposed approval obligation with the FDA, so we have consulted with them for the product.
正如我們所說,這項研究設計得非常好,考慮到研究的一切都是在註冊後提出的,向 FDA 提出的批准義務,所以我們就產品與他們進行了協商。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you.
謝謝你。
On the Phase 2, do you want to talk to that, Mikael, perhaps?
在第 2 階段,你想談談嗎,Mikael,也許?
Mikael Dolsten - President, Worldwide Research & Development
Mikael Dolsten - President, Worldwide Research & Development
I thought that I'll add one comment on the herd effect that Alex asked about.
我想我會添加一條關於亞歷克斯所問的羊群效應的評論。
Actually in 2013, there's been some very useful publication from UK and US that have studied the epidemiology of various pneumococcal strains, and have clearly shown that in the adult, and in particular the older adult population that is highly vulnerable to pneumococcal, there is a number of Prevnar 13 strains still occurring linked to disease.
實際上,在 2013 年,英國和美國發表了一些非常有用的出版物,研究了各種肺炎球菌菌株的流行病學,並清楚地表明,在成年人,特別是高度易感染肺炎球菌的老年人群中,存在仍然存在與疾病有關的 Prevnar 13 菌株的數量。
And actually even Prevnar 7 strains are occurring, so it suggests that the older population is more prone to pick up those strains, and interesting is some strains that are not causing disease in younger population can cause substantial disease in the older population where we also see a substantially increased mobility and also fatal outcomes.
實際上,甚至 Prevnar 7 菌株也在發生,因此這表明老年人更容易感染這些菌株,有趣的是,一些不會在年輕人群中引起疾病的菌株會在老年人群中引起嚴重疾病,我們也看到了極大地增加了流動性,也帶來了致命的後果。
So we do believe that the recent data will favor the view of an existing unmet need in this population.
因此,我們確實相信,最近的數據將有利於這一人群中現有未滿足需求的觀點。
And as Albert alluded to pending the readout of CAPiTA, this would be the only available study of this size that would show any effect in this population.
正如阿爾伯特提到的等待 CAPiTA 的讀數,這將是唯一可用的這種規模的研究,它會在這個人群中顯示任何影響。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Mikael.
謝謝你,米凱爾。
You know, it's good questions and good to speculate.
你知道,這是很好的問題和很好的推測。
We'll know by the end of the quarter and then we can discuss it in more detail.
我們將在本季度末知道,然後我們可以更詳細地討論它。
Albert, on the overall survival, palbo?
阿爾伯特,關於整體生存,帕爾博?
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Yes, the data for overall survival is event driven so, therefore, it's difficult to predict when the final overall survival data will be completed.
是的,總生存期數據是事件驅動的,因此很難預測最終總生存期數據何時完成。
Apparently the study is well powered to catch any differences.
顯然,這項研究能夠很好地捕捉到任何差異。
We do anticipate preliminary overall survival data that could be presented at the medical conference in the first half of 2014 together with the other data.
我們確實預計初步總體生存數據可能會在 2014 年上半年的醫學會議上與其他數據一起公佈。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Albert.
謝謝你,阿爾伯特。
Operator
Operator
Thanks, Albert.
謝謝,阿爾伯特。
Next question please, Operator.
下一個問題,接線員。
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。
I just have two.
我只有兩個。
Just on Prevnar 13, you indicated that there is three times the ACIP meets.
就在 Prevnar 13 上,您表示 ACIP 舉行了 3 次會議。
What's the earliest meeting and have you asked the ACIP yet for to be part of the agenda of any one of those three meetings yet?
最早的會議是什麼,您有沒有要求 ACIP 成為這三個會議中任何一個會議議程的一部分?
And then secondly on palbociclib, if you look at your binding affinity for CDK4 and CDK6, most notably on cyclin D1 and D2, for CDK4 it's 11-nanometer and 9-nanometer.
然後在 palbociclib 上,如果您查看您對 CDK4 和 CDK6 的結合親和力,最顯著的是對 cyclin D1 和 D2 的結合親和力,對於 CDK4,它是 11 納米和 9 納米。
In cyclin D6, IC50 is 15-nanometer, which suggests a high degree of affinity, hence strongly correlated to efficacy.
在 cyclin D6 中,IC50 為 15 納米,這表明具有高度的親和力,因此與功效密切相關。
Is there any way you might be able to contrast that to the activity of the Novartis and Lilly compounds?
有什麼方法可以將其與諾華和禮來化合物的活性進行對比?
And then the second part of that question on palbo is there are some off target effects that occur on greater than 30 other kinases.
然後關於 palbo 的問題的第二部分是在超過 30 種其他激酶上發生了一些脫靶效應。
Has the FDA asked you to try and characterize any of those off target effects on palbo?
FDA 是否要求您嘗試描述任何對 palbo 的脫靶效應?
Thanks.
謝謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, John.
謝謝你,約翰。
Prevnar 13, ACIP, I think there are three meetings, one in February, one in June, and one in October.
Prevnar 13,ACIP,我認為有3 次會議,2 月1 次,6 月1 次,10 月1 次。
I would find it doubtful we would make the February date, and then when we have the results we will immediately engage with ACIP to see if they can review the results at the earliest point possible, and one would expect there when we used do that would depend on the results in many ways.
我會懷疑我們是否會確定 2 月的日期,然後當我們得到結果時,我們將立即與 ACIP 接洽,看看他們是否可以儘早審查結果,並且當我們使用時,人們會期望這樣做會在很多方面取決於結果。
Mikael, there was a comment on John's very scientific question there on palbo.
Mikael,在 palbo 上有一篇關於 John 非常科學的問題的評論。
Mikael Dolsten - President, Worldwide Research & Development
Mikael Dolsten - President, Worldwide Research & Development
Yes, John, so I mean pressed with your detail that understanding of this kinase inhibitor, and as you very well articulated, we designed an inhibitor that would have potent activity against both kinases, which I do think is somewhat unique for palbociclib.
是的,約翰,所以我的意思是強調你對這種激酶抑製劑的理解的細節,正如你很好地表達的那樣,我們設計了一種對兩種激酶都有有效活性的抑製劑,我認為這對於 palbociclib 來說有些獨特。
All kinases have some of target activities, but we do believe that therapeutic window for palbociclib favors the on target profile.
所有激酶都具有一些靶向活性,但我們確實相信 palbociclib 的治療窗口有利於靶向作用。
And if you look at efficacy and tolerability we've seen so far, the main adverse events related to neutropenia that has been well manageable is very much compatible with on target effect for these type of drugs.
如果你看看我們迄今為止看到的療效和耐受性,與中性粒細胞減少症相關的主要不良事件已經很好地控制,與這類藥物的目標效應非常吻合。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
And we don't have enough detail on the competitive approach to make any comparisons, is that correct?
而且我們沒有足夠的競爭方法細節來進行任何比較,對嗎?
Mikael Dolsten - President, Worldwide Research & Development
Mikael Dolsten - President, Worldwide Research & Development
Yes, we tend not to comment on either products and that's why I used the term that our inhibitors are well balanced and has a unique profile in that sense.
是的,我們傾向於不對這兩種產品發表評論,這就是為什麼我使用我們的抑製劑平衡良好並且在這個意義上具有獨特特徵的術語。
And I think what at this stage of clinical development, as Albert very well alluded to, we need to understand more from the competitive products as they advance in development.
而且我認為在臨床開發的這個階段,正如 Albert 很好地暗示的那樣,隨著競爭產品的發展,我們需要更多地了解它們。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you.
謝謝你。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Mikael.
謝謝,米凱爾。
Our next question please, Operator.
請操作員,我們的下一個問題。
Operator
Operator
Your next question is 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
Yes, thanks for taking the questions.
是的,感謝您提出問題。
I have two on the pipeline for palbo, just you started quite a few studies now outside of breast cancer where I think most of the focus has been.
我有兩個正在為 palbo 準備,只是你現在在乳腺癌之外開始了很多研究,我認為大部分重點都在這些研究上。
Can you just talk at this point where you see palbo having the most potential outside of the lead breast cancer indication?
您能否談談您認為 palbo 在領先的乳腺癌適應症之外最有潛力的地方?
And then second on the PCSK9, just any comments there?
然後是 PCSK9,有什麼意見嗎?
You're going into Phase 3. Obviously, it's a large study, a lot of investment needed there.
您將進入第三階段。顯然,這是一項大型研究,需要大量投資。
Given some of the changing guidelines, maybe less of an emphasis on LDL and HDL target levels, how do you see the value of a PCSK9 program and would you consider maybe partnering that with someone just given the amount that you would need to invest there?
鑑於一些不斷變化的指導方針,可能不太強調 LDL 和 HDL 目標水平,您如何看待 PCSK9 計劃的價值,您是否會考慮與剛剛給出您需要在那裡投資的金額的人合作?
Thanks.
謝謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
So, good questions.
所以,好問題。
Palbo, Albert, outside of breast cancer you may want to discuss a little bit of what we're doing there and then Geno will do the PSK9 reply.
Palbo,Albert,除了乳腺癌之外,您可能想討論一下我們在那裡所做的事情,然後 Geno 將回复 PSK9。
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Albert Bourla - President of Vaccines, Oncology, and Consumer Healthcare Business
Vamil, expanding palbo beyond breast cancer is a top priority for us.
Vamil,將 palbo 擴展到乳腺癌之外是我們的首要任務。
And given the potential of different size, we are very focused in progressing in other tumor types, as melanoma for example, there is an ongoing Phase 1, 2 study of palbo with Zelboraf.
鑑於不同大小的潛力,我們非常專注於其他腫瘤類型的進展,例如黑色素瘤,目前正在進行 palbo 與 Zelboraf 的 1 期、2 期研究。
And this is conducted by the National Cancer Institute of France and this is for BRAF mutations.
這是由法國國家癌症研究所進行的,這是針對 BRAF 突變的。
Also, in addition I'm sure you have seen a recent announcement.
此外,我相信您已經看到了最近的公告。
We are working with GSK to evaluate palbo with their MAC inhibitor in metastatic melanoma this time without BRAF mutations, and this trial should begin in the first half of the year of 2014.
我們正在與葛蘭素史克合作,這次在沒有 BRAF 突變的情況下,用他們的 MAC 抑製劑評估 palbo 治療轉移性黑色素瘤,這項試驗應該在 2014 年上半年開始。
Now if we look beyond melanoma, we are working with academic centers, including the Dana-Farber Cancer Center, to evaluate palbo in non-small cell lung cancer and to have universal other collaborations and programs in other tumor types, including squamous non-small cell lung cancer and head and neck cancer.
現在,如果我們超越黑色素瘤,我們正在與包括 Dana-Farber 癌症中心在內的學術中心合作,以評估 palbo 在非小細胞肺癌中的療效,並在其他腫瘤類型(包括鱗狀非小細胞肺癌)中開展普遍的其他合作和項目細胞肺癌和頭頸癌。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you Albert.
謝謝你阿爾伯特。
Mike, I'm sorry, Geno, PCSK9?
邁克,對不起,杰諾,PCSK9?
Geno Germano - President of Global Innovative Pharma
Geno Germano - President of Global Innovative Pharma
On PCSK9, we've initiated our Phase 3 program.
在 PCSK9 上,我們已經啟動了第 3 階段計劃。
It's a broad program, as you can imagine, with multiple liquid boring studies, and we've decided to go into two fairly large outcome studies as well with the intent to provide the broadest base of data of any of the PCSK9 programs in the patient populations that we believe can benefit from this therapy.
正如您可以想像的那樣,這是一個廣泛的計劃,包含多項液體鑽孔研究,我們決定進行兩項相當大的結果研究,旨在為患者提供任何 PCSK9 計劃的最廣泛數據基礎我們認為可以從這種療法中受益的人群。
We believe that outcomes, trials, and the results of the outcome trials are going to determine the place for these agents in management of patients with cardiovascular risk factors and high cholesterol levels.
我們相信結果、試驗和結果試驗的結果將決定這些藥物在心血管危險因素和高膽固醇水平患者管理中的地位。
And our programs are designed to read out in a similar time frame of the competitive programs as well.
我們的節目也被設計為在與競爭節目類似的時間範圍內讀出。
So we're excited about the program, we're often running with our Phase 3 program, and we're at this point going it alone.
因此,我們對該計劃感到興奮,我們經常與我們的第 3 階段計劃一起運行,而且我們目前正在單獨進行。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Geno.
謝謝你,杰諾。
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 Andrew Baum from Citi.
您的下一個問題來自花旗的 Andrew Baum。
Andrew Baum - Analyst
Andrew Baum - Analyst
Good morning.
早上好。
First on palbo, should I assume that in the absence of any significant OS benefit from the Phase 2, you would not file under accelerated approval?
首先在 palbo 上,我是否應該假設在第 2 階段沒有任何顯著的操作系統收益的情況下,您不會在加速批准下提交文件?
And then in addition, you made some comment about the manageability of the neutropenia, should I assume that's still the case, i.e., the profile hasn't changed from the early patient experience?
此外,您對中性粒細胞減少症的可管理性發表了一些評論,我是否應該假設情況仍然如此,即情況與早期患者體驗相比沒有改變?
And then, finally, you attained the rights to both tremelimumab and your anti-CD40 together with use with vaccines.
然後,最後,您獲得了 Tremelimumab 和您的抗 CD40 以及與疫苗一起使用的權利。
Do you have any vaccines close to entering clinical development in combination with either of these two assets?
您是否有與這兩項資產中的任何一項相結合的即將進入臨床開發的疫苗?
Thank you.
謝謝你。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Andrew.
謝謝你,安德魯。
Look, on palbo, I don't think we can assume anything on the path forward until we see the results and then we will be in conversations with the FDA.
看,在 palbo 上,我認為在我們看到結果之前,我們不能在前進的道路上做出任何假設,然後我們將與 FDA 進行對話。
And as you say, overall survival is driven, event driven, and may take a longer time, but we'll just have to wait for the results that have in depth discussions with the FDA.
正如你所說,總體生存是由事件驅動的,可能需要更長的時間,但我們只需要等待與 FDA 進行深入討論的結果。
Mikael, do you want to talk about the profile, vis-a-vis neutropenia, and also then discuss the tremelimumab and the CD40?
Mikael,您想談談關於中性粒細胞減少症的概況,然後再討論曲美木單抗和 CD40 嗎?
Mikael Dolsten - President, Worldwide Research & Development
Mikael Dolsten - President, Worldwide Research & Development
Yes, so the type of profile we have reported, which is very well compatible with what you will see with this type of drug, has been very well manageable in the clinic and seems to be much more tolerable than previous experience with the drugs in used in solid tumors when it relates to hematological suppression.
是的,所以我們報告的配置文件類型與您將看到的此類藥物非常兼容,在臨床上非常易於管理,並且似乎比以前使用藥物的經驗更容易忍受在與血液學抑制有關的實體瘤中。
So we feel very comfortable with the profile and look forward, as Ian alluded to, to see the final results.
因此,正如 Ian 所暗示的,我們對配置文件感到非常滿意,並期待看到最終結果。
And clearly, at this stage of development, it's progression pre-survival that will be the dominant end point to look for.
顯然,在這個發展階段,生存前的進展將是尋找的主要終點。
In the vaccines area, you were right.
在疫苗領域,你是對的。
We retained use for tremelimumab, particularly I would like to underline that antibody is part of the platform we are exploring together with unique prostate vaccine antigens and a very comprehensive delivery method of the vaccine to boost immune response.
我們保留了 Tremelimumab 的使用,特別是我想強調抗體是我們正在探索的平台的一部分,以及獨特的前列腺疫苗抗原和非常全面的疫苗遞送方法以增強免疫反應。
Our initial focus is on prostate cancer and we aspire to be in human studies by 2015.
我們最初的重點是前列腺癌,我們渴望到 2015 年進入人體研究。
And at that time point, you will actually see a number of Pfizer cancer immunotherapy approaches move forward based on a panel of different monitorable antibodies.
到那時,您實際上會看到輝瑞的許多癌症免疫治療方法基於一組不同的可監測抗體向前發展。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Mikael.
謝謝你,米凱爾。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thanks, Mikael.
謝謝,米凱爾。
Next question, please, Operator.
下一個問題,請接線員。
Operator
Operator
Your next question comes from Tony Butler from Barclays.
您的下一個問題來自巴克萊的托尼·巴特勒。
Tony Butler - Analyst
Tony Butler - Analyst
Thanks very much.
非常感謝。
Good morning.
早上好。
Just a brief question.
只是一個簡短的問題。
As you late last year made references to splitting out the units into three different business units, you focused on collagen vaccines claiming that there was the need for laser like focus on these areas because they clearly are growing substantially above the corporate rate.
當您去年年底提到將這些部門拆分為三個不同的業務部門時,您專注於膠原蛋白疫苗,聲稱需要像激光一樣專注於這些領域,因為它們的增長明顯高於公司增長率。
That's all -- that's clearly understandable.
就是這樣——這很明顯可以理解。
You included consumer at the time.
您當時包括了消費者。
As I seem to recall it was either Frank or you, Ian, made the reference that it was because the manager of the consumer business would then be the manager of both.
我似乎記得是弗蘭克或你,伊恩,提到這是因為消費者業務的經理將成為兩者的經理。
Now that Albert is head of that, does it not now make sense that consumer would be split apart, again because of this laser like focus on vaccines and oncology?
既然阿爾伯特是這方面的負責人,那麼現在消費者是否會因為這種對疫苗和腫瘤學的關注而分裂,這難道不是有意義的嗎?
Thanks very much.
非常感謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, Tony.
謝謝你,托尼。
I think the structure is important but not overriding.
我認為結構很重要,但不是壓倒一切的。
What's overriding is having really good leaders running the oncology and the vaccine business, having transparency on their results, having somebody good running consumer, and then having an overall President who has done tremendously good work in the Established Products in the value business and somebody who is a seasoned leader.
最重要的是擁有真正優秀的領導者來管理腫瘤學和疫苗業務,他們的結果具有透明度,有一個優秀的消費者管理,然後有一個在價值業務的既定產品方面做得非常出色的整體總裁,還有一個人是一位經驗豐富的領導者。
So I don't think it's important, vis-a-vis my small tweaks in the structure because of changes or leaders, but thank you for the question.
所以我認為這並不重要,相對於我由於變化或領導而對結構進行的小調整,但謝謝你的問題。
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
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 a lot and thanks for the questions.
非常感謝,感謝您的提問。
And Frank, thank you for the incredible detail on the P&L structures, that was great.
弗蘭克,感謝您提供有關損益表結構的令人難以置信的詳細信息,這太棒了。
But separately on you mentioned the staph aureus showing some preliminary evidence of efficacy.
但你單獨提到金黃色葡萄球菌顯示出一些初步的療效證據。
Can you just give us maybe a little bit of color as to what you were looking for in terms of the quality of the immune response?
您能否就您在免疫反應質量方面尋找的內容,給我們一點顏色?
Should we anticipate some threshold of real evidence of oxidizing antibodies actually showing since it's my understanding that that's what's necessary to really eradicate or fight the disease?
我們是否應該預期一些實際顯示氧化抗體的真實證據的閾值,因為我的理解是,這是真正根除或對抗疾病所必需的?
And then separately, as we think about some of the products in earlier stages of development, would you mind just maybe giving us a little bit of color as to the products in Phase 2, outside of the products that were mentioned on the call today, that might be particularly exciting, particularly as we think about the prospect for combinations in your cancer portfolio?
然後另外,當我們考慮一些處於早期開發階段的產品時,您是否介意給我們一些關於第二階段產品的顏色,除了今天電話會議中提到的產品,這可能特別令人興奮,尤其是當我們考慮在您的癌症組合中組合的前景時?
Thanks a lot.
非常感謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Okay.
好的。
Thank you.
謝謝你。
Really good question.
真是個好問題。
So Mikael, you're a popular man today.
所以米凱爾,你今天是個受歡迎的人。
Mikael Dolsten - President, Worldwide Research & Development
Mikael Dolsten - President, Worldwide Research & Development
Okay.
好的。
So thank you very much for your interest in staph aureus vaccine.
非常感謝您對金黃色葡萄球菌疫苗的關注。
That's based on some very serious science that we invested in over the last couple of years.
這是基於我們在過去幾年投資的一些非常嚴肅的科學。
And we identified four different antigens and both polysaccharide and proteins that we have shown at least at a high level of antibodies in the H-relevant individuals.
我們確定了四種不同的抗原以及多醣和蛋白質,我們至少在 H 相關個體中顯示出高水平的抗體。
And as you discussed, these induced antibodies will both induce what you call oxidation, clearance of the antibody by the immune system.
正如你所討論的,這些誘導抗體都會誘導你所說的氧化,即免疫系統清除抗體。
But also they will interfere with the bacterial function, which is based on some unique science that we have done for this particular vaccine.
但它們也會干擾細菌功能,這是基於我們為這種特殊疫苗所做的一些獨特科學。
We saw very nice levels of induced antibodies rapid onset, with really the profile you would like to see before you vaccinate individuals to go into a surgical environment where there may be threatened with difficult infection.
我們看到了非常好的水平的誘導抗體快速起效,在您為個體接種疫苗以進入可能面臨困難感染威脅的手術環境之前,您確實希望看到這種情況。
And I would like to underline that the antibodies cross-react with a large majority of staph aureus strains, including the multi-resistant strains that can cause devastating outcome of hospitalization.
我想強調的是,抗體與絕大多數金黃色葡萄球菌菌株發生交叉反應,包括可能導致住院治療的毀滅性後果的多重耐藥菌株。
So we are very encouraged by the data and we've shared it with both European and US regulators, and we are now in dialogues around the phase to be started that we will invest in to show event reduction of infection in a presurgical population.
因此,我們對這些數據感到非常鼓舞,我們已經與歐洲和美國的監管機構分享了它,我們現在正在圍繞即將開始的階段進行對話,我們將投資以顯示減少術前人群感染的事件。
Concerning your interest in our Phase 2 pipeline, I would like to underline that we have a rich pipeline with a lot of momentum behind a kind of near term excitement around palbociclib, an adult vaccine.
關於您對我們的第 2 階段管道的興趣,我想強調一下,我們擁有豐富的管道,在成人疫苗 palbociclib 的近期興奮背後有很大的動力。
Just a few highlights.
只是幾個亮點。
We have started multiple Phase 2 for our smoothing inhibitor in blood cancers and related blood disorders, an area that we are very excited about.
我們已經開始了針對血癌和相關血液疾病的平滑抑製劑的多個第 2 階段,這是我們非常興奮的一個領域。
And we're also moving a gamma-secretase inhibitor into triple negative breast cancer where we have seen some very interesting and favorable profiles so far.
我們還將一種γ-分泌酶抑製劑轉移到三陰性乳腺癌中,到目前為止,我們已經看到了一些非常有趣和有利的概況。
In the Xalkori space, we are now dosing patients with a full on drug that is targeting all known mutations and we think can have a very exciting profile.
在 Xalkori 領域,我們現在正在給患者服用一種針對所有已知突變的完整藥物,我們認為這可能會有一個非常令人興奮的情況。
We've already moved one antibody drug conjugate into the clinic and we have several more that would move into the clinic this year.
我們已經將一種抗體藥物偶聯物移入臨床,今年我們還將有更多的抗體藥物偶聯物進入臨床。
In inflammation immunology, we have readouts in this year of our best-in-class IL-6 antibody across numerous immune conditions, similar for our MAdCAM antibody, and also for our small molecule disassociated glucocorticoid receptor.
在炎症免疫學方面,今年我們在多種免疫條件下獲得了同類最佳 IL-6 抗體的讀數,類似於我們的 MAdCAM 抗體,也適用於我們的小分子分離糖皮質激素受體。
And then in vaccine, we also have noticed favorable Phase 1b data with clostridium difficile and moving forward with one of our formulations towards Phase 2 initiation this year.
然後在疫苗方面,我們還注意到艱難梭菌的有利 1b 期數據,並在今年將我們的一種製劑推向第 2 期啟動。
And Ian alluded briefly in his introductory remark to some extended work we're doing into renal diseases where we have seen positive Phase 2a data of our novel PD5 inhibitor.
Ian 在他的介紹性評論中簡要提到了我們在腎臟疾病方面所做的一些擴展工作,我們已經看到了我們新型 PD5 抑製劑的積極 2a 期數據。
We also moved a second drug, a CCR-25 dual inhibitor into diabetic nephropathy and diabetic macular edema, underlining the important opportunity medical and commercial we see in this disease.
我們還將第二種藥物 CCR-25 雙重抑製劑用於糖尿病腎病和糖尿病黃斑水腫,強調了我們在這種疾病中看到的重要醫療和商業機會。
And you may also noted some other highlights including a dual acting inhibitor of uric acid for gout therapy that we recently acquired through a licensing agreement with Kissei.
您可能還會注意到其他一些亮點,包括我們最近通過與 Kissei 的許可協議獲得的用於痛風治療的雙效尿酸抑製劑。
So I think you will continue to see great momentums with internal and external partnership in this area.
因此,我認為您將繼續看到該領域內外部合作的良好勢頭。
Thank you for your interest.
感謝您的關注。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you, and of course on top of that we do have the Phase 3 Xeljanz data coming out and meningitis B. And so I think it's a strong pipeline across all phases.
謝謝,當然除此之外,我們確實有第 3 階段的 Xeljanz 數據和 B 型腦膜炎數據。所以我認為這是一個跨越所有階段的強大管道。
Thank you, Mikael.
謝謝你,米凱爾。
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 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。
Frank, I appreciated all the detail that you provided.
弗蘭克,我很欣賞你提供的所有細節。
I just wanted to follow up though.
我只是想跟進。
Some potential acquirers of the Established Products Business have implied or suggested that Pfizer can indeed retroactively audit going backwards, and so could you just sort of settle the debate?
一些既定產品業務的潛在收購者暗示或暗示輝瑞確實可以追溯審計,所以你能解決這個爭論嗎?
Could you talk about why Pfizer cannot retroactively audit going backwards and just explain whether there's any gray area there?
你能談談為什麼輝瑞公司不能追溯審計,只是解釋那裡是否有任何灰色區域?
That would be great, thanks so much.
那太好了,非常感謝。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
Sure.
當然。
So Dave, I mentioned before that three years audited financials and I used the word prospective.
所以戴夫,我之前提到過三年經審計的財務,我使用了預期這個詞。
The reason I use the word prospective was if not prospective, then it would have to be some portion of retrospective.
我使用預期這個詞的原因是,如果不是預期,那麼它必須是回顧的一部分。
Remember, if you're doing something retrospectively it's not just an income statement.
請記住,如果您回顧性地做某事,那不僅僅是損益表。
It's also a balance sheet.
這也是一個資產負債表。
It's a cash flow statement.
是現金流量表。
And these are businesses that in their new construct didn't exist previously to 2014, so it's the complexity involved in their not existing and the full suite of financial statements required, which is why I said prospectively.
這些是在 2014 年以前不存在的新結構中的業務,因此它們不存在所涉及的複雜性以及所需的全套財務報表,這就是我前瞻性地說的原因。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thanks, Frank.
謝謝,弗蘭克。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
And our last question, please, Operator.
最後一個問題,請操作員。
Operator
Operator
Your final question comes from Damien Conover from Morningstar.
您的最後一個問題來自晨星公司的 Damien Conover。
Damien Conover - Analyst
Damien Conover - Analyst
Great, thanks for taking the questions.
太好了,感謝您提出問題。
Just two quick questions.
只是兩個簡單的問題。
First on Eliquis, the Lancet in December published a meta analysis that looked at the different anticoagulants and really showed little differentiation among them, obviously better than Warfarin.
首先在 Eliquis 上,《柳葉刀》在 12 月發表了一項薈萃分析,研究了不同的抗凝劑,實際上它們之間幾乎沒有區別,明顯優於華法林。
But I wanted to get your sense of the marketing effort and if you're finding ways to market Eliquis and get a better response over Xarelto and Pradaxa?
但我想了解您的營銷工作,如果您正在尋找營銷 Eliquis 的方法並獲得比 Xarelto 和 Pradaxa 更好的回應?
And secondly, just a question on the potential breakup of the Company.
其次,只是關於公司可能分拆的問題。
If you look forward to patent losses beyond the breakup, just trying to get an understanding of how assets might stay within companies or shift companies?
如果您期待分拆後的專利損失,只是想了解資產如何留在公司內部或轉移公司?
For example, with Lyrica I think the patent loss is 2019, how would something like that -- would that stay with the branded Company or would it shift to the established Company, and just trying to get a sense of how that strategy might play out?
例如,對於 Lyrica,我認為專利損失是 2019 年,這樣的事情會如何——它會留在品牌公司還是轉移到老牌公司,只是試圖了解該戰略可能會如何發揮作用?
Thanks.
謝謝。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you.
謝謝你。
So, I'll take that second question first and then ask Geno to comment on the differentiation and the confidence one can have in meta analysis and compared to randomized perfected trials.
因此,我將首先回答第二個問題,然後請 Geno 評論人們在薈萃分析中的差異和信心,並與隨機完善試驗進行比較。
So look, I think the way you see we've set up our divisions now and the sort of transfer of assets is probably similar to what we would do if there was a separation, but it would depend upon what type of separation it was, and clearly you'd have to operate to maximize the value, initially to Pfizer's shareholders at that time, and then there would be commercial considerations on how you ensure that continuing LOEs get well managed by an organization that is capable to maximize it.
所以看,我認為你看到我們現在建立部門的方式和資產轉移的方式可能類似於如果有分離我們會做的事情,但這取決於它是什麼類型的分離,顯然,您必須運營以最大化價值,最初是針對當時輝瑞的股東,然後會考慮如何確保持續的 LOE 得到能夠最大化價值的組織的良好管理。
So I think your question is a little hypothetical at this time without knowing exactly how we would, if with do, do any type of breakup or separation.
所以我認為你的問題在這個時候有點假設,不知道我們將如何做,如果這樣做,做任何類型的分手或分離。
Whether it would be selling to another company or a spin, that would clearly change the nature of the transactions et cetera, et cetera.
無論是出售給另一家公司還是旋轉,這都會明顯改變交易的性質等等。
So in all cases, we would be focused on doing what was right for our shareholders and then ensuring maximum value.
因此,在所有情況下,我們都將專注於為股東做正確的事情,然後確保最大價值。
Geno, do you want to add any comments on?
Geno,你想添加任何評論嗎?
Geno Germano - President of Global Innovative Pharma
Geno Germano - President of Global Innovative Pharma
Yes, just a comment on our data sets.
是的,只是對我們的數據集的評論。
I mean, our Eliquis data set is really an outstanding data set, a randomized prospective controlled clinical trial demonstrating superiority across three important efficacy and safety end points.
我的意思是,我們的 Eliquis 數據集確實是一個出色的數據集,一項隨機前瞻性對照臨床試驗證明了在三個重要的療效和安全性終點方面的優越性。
It's a extremely strong database and, frankly, having randomized trials with those results is the strongest form of evidence that we could possibly have.
這是一個非常強大的數據庫,坦率地說,對這些結果進行隨機試驗是我們可能擁有的最有力的證據。
What we're doing with that that's really helping us in a competitive field is taking it to, frankly, the clinicians that can understand and appreciate the data the best, and that's the specialists, the cardiologists.
坦率地說,我們正在做的真正有助於我們在競爭領域中的工作是把它帶給能夠最好地理解和欣賞數據的臨床醫生,那就是專家,心髒病專家。
We've increased substantially our medical education, our focus on the cardiologists, and as a result we've seen a nice response.
我們大大增加了我們的醫學教育,我們對心髒病專家的關注,結果我們看到了很好的反應。
In fact, we use as a leader indicator new to brand prescriptions and we're watching new to brand prescriptions.
事實上,我們使用新品牌處方作為領先指標,並且我們正在關注新品牌處方。
This is prescriptions where the patient is getting a new brand.
這是患者獲得新品牌的處方。
And across all of the business we're now over 25%, and among cardiologists we're about 30%, and we've surpassed Pradaxa and we're growing at a more rapid rate than Xarelto.
在所有業務中,我們現在超過 25%,在心髒病專家中,我們約佔 30%,我們已經超過了 Pradaxa,並且我們的增長速度比拜瑞妥更快。
So we think we've got good momentum going here and it's on the back of the excellent data set we have.
因此,我們認為我們在這方面取得了良好的發展勢頭,這得益於我們擁有的出色數據集。
Ian Read - Chairman, CEO
Ian Read - Chairman, CEO
Thank you.
謝謝你。
Chuck Triano - SVP of IR
Chuck Triano - SVP of IR
Thank you.
謝謝你。
And thank you this morning for everyone's attention.
今天早上感謝大家的關注。
Thanks.
謝謝。
Frank D'Amelio - CFO
Frank D'Amelio - CFO
So long, everybody.
大家好久不見
Thank you.
謝謝你。
Operator
Operator
Ladies and gentlemen, this concludes the Pfizer's fourth-quarter 2013 earnings conference call.
女士們先生們,輝瑞公司 2013 年第四季度財報電話會議到此結束。
Thank you for participating.
感謝您的參與。
You may now disconnect.
您現在可以斷開連接。