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Operator
Operator
Good day, everyone, and welcome to Pfizer's Fourth Quarter 2019 Earnings Conference Call.
大家好,歡迎參加輝瑞公司 2019 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。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Morning, and thank you for joining us today to review Pfizer's fourth quarter and full year 2019 performance and 2020 financial guidance.
早上好,感謝您今天加入我們,回顧輝瑞公司 2019 年第四季度和全年業績以及 2020 年財務指導。
I'm joined today by our CEO and Chairman, Albert Bourla; Frank D'Amelio, our CFO; Mikael Dolsten, President of Worldwide Research and Development; Angela Hwang, Group President, Pfizer Biopharmaceuticals Group; John Young, our Chief Business Officer; and Doug Lankler, General Counsel.
今天,我們的首席執行官兼董事長 Albert Bourla 加入了我的行列;我們的首席財務官 Frank D'Amelio; Mikael Dolsten,全球研發總裁;輝瑞生物製藥集團總裁Angela Hwang;我們的首席商務官 John Young;和總法律顧問 Doug Lankler。
The slides that will be presented on this call were posted to our website earlier this morning and are available at pfizer.com/investors.
將在本次電話會議上展示的幻燈片已於今天上午早些時候發佈到我們的網站上,可在 pfizer.com/investors 上獲取。
You'll see here that Slide 3 covers our legal disclosures.
您將在此處看到幻燈片 3 涵蓋了我們的法律披露。
Albert and Frank will now make prepared remarks, and then we will move to a question-and-answer session.
阿爾伯特和弗蘭克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 Albert Bourla.
有了這個,我現在將把電話轉給 Albert Bourla。
Albert?
阿爾伯特?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Chuck, and good morning, everyone.
謝謝你,查克,大家早上好。
This morning, I will speak about our performance for the year, the continued advancement of our pipeline and the steps we are taking to position Pfizer for accelerated growth, following the expected separation of Upjohn from Pfizer later this year.
今天上午,我將談論我們今年的業績、我們管道的持續推進以及我們正在採取的步驟,以使輝瑞公司在今年晚些時候從輝瑞公司(Upjohn)預計分拆後加速增長。
Frank will then provide details regarding our fourth quarter performance and our 2020 financial guidance.
然後,弗蘭克將提供有關我們第四季度業績和 2020 年財務指導的詳細信息。
2019 was a productive and transformational year for Pfizer, in which we generated solid full year financial results.
2019 年對輝瑞來說是富有成效和轉型的一年,我們在這一年取得了穩健的全年財務業績。
These results were highlighted by exceptional 8% operational revenue growth for the year and 9% in the fourth quarter for our Biopharma business, which will become the new Pfizer following the expected separation of Upjohn.
我們的生物製藥業務今年的營業收入增長了 8%,第四季度增長了 9%,這突出了這些結果,這將成為輝瑞(Pfizer)在 Upjohn 的預期分離之後的新成員。
Once again, our Biopharmaceuticals Group, outstanding growth was driven primarily by the continued strong performance from all our key growth drivers.
再一次,我們的生物製藥集團的出色增長主要是由我們所有關鍵增長驅動因素的持續強勁表現推動的。
This include Ibrance, Xtandi, Eliquis, Xeljanz, VYNDAQEL, among others.
這包括 Ibrance、Xtandi、Eliquis、Xeljanz、VYNDAQEL 等。
Biopharma also generated 14% operational growth in emerging markets in 2019.
2019 年,生物製藥在新興市場也實現了 14% 的運營增長。
I would point out that Biopharma's 2019 growth came from volume increases, not pricing.
我要指出,Biopharma 2019 年的增長來自銷量增長,而不是定價。
In fact, pricing had a negative 2% impact in Biopharma's results.
事實上,定價對 Biopharma 的業績產生了 2% 的負面影響。
For full year 2019, global Ibrance revenues increased 23% operationally to become a nearly $5 billion a year product.
2019 年全年,全球 Ibrance 收入運營增長 23%,成為每年近 50 億美元的產品。
In the U.S., Ibrance realized robust growth and retained its strong leadership position in the CDK class with a nearly 90% share.
在美國,Ibrance 實現了強勁增長,並以近 90% 的份額保持了其在 CDK 類別中的強大領導地位。
Ibrance performance outside of the U.S. was also very strong, and we still see significant opportunities in countries where the use of CDK inhibitors has not yet reached the levels seen in the U.S. Overall, Ibrance is approved in more than 90 countries.
Ibrance 在美國以外的表現也非常強勁,在 CDK 抑製劑的使用尚未達到美國水平的國家,我們仍然看到了巨大的機會。總體而言,Ibrance 在 90 多個國家/地區獲得批准。
It's the #1 prescribed CDK 4/6 inhibitor globally and has reached more than 250,000 patients.
它是全球排名第一的處方 CDK 4/6 抑製劑,已惠及超過 250,000 名患者。
For Xtandi, alliance revenues in the U.S. were up 20% for the full year, and when combined with our royalty income on ex U.S. sales, totaled nearly $1.2 billion in 2019.
對於 Xtandi 而言,美國的聯盟收入全年增長了 20%,加上我們在美國以外的銷售的特許權使用費收入,在 2019 年總計近 12 億美元。
Xtandi is the leading branded novel hormone therapy in an increasingly competitive but growing class, with 37% market share in total prescriptions.
Xtandi 是競爭日益激烈但不斷增長的類別中領先的品牌新型激素療法,在總處方中佔有 37% 的市場份額。
The robust year-over-year growth was due to continued uptake of the non-metastatic castration-resistant prostate cancer indication as well as prescriber confidence and recognition of Xtandi's strong data across CRPC.
強勁的同比增長是由於非轉移性去勢抵抗性前列腺癌適應症的持續採用以及處方者對 Xtandi 在 CRPC 中強大數據的信心和認可。
With the recent launch of our extended indication in metastatic castration-sensitive prostate cancer in the U.S., Xtandi is now the first and only oral treatment approved by the FDA in 3 distinct types of prostate cancer.
隨著我們最近在美國推出針對轉移性去勢敏感性前列腺癌的擴展適應症,Xtandi 現在是 FDA 批准的第一個也是唯一一個口服治療 3 種不同類型前列腺癌的藥物。
Eliquis continued to perform well.
Eliquis 繼續表現良好。
Pfizer's share in the global revenues was up 26% operationally to $4.2 billion.
輝瑞在全球營業收入中的份額增長了 26%,達到 42 億美元。
This growth was driven primarily by continued increased adoption in nonvalvular atrial fibrillation as well as oral anticoagulant market share gains.
這一增長主要是由於非瓣膜性心房顫動的持續增加以及口服抗凝劑市場份額的增加。
Eliquis is now the oral anticoagulant leader in 12 markets across the globe.
Eliquis 現在是全球 12 個市場的口服抗凝劑領導者。
Xeljanz had a strong performance with global revenues increasing 29% operationally to $2.2 billion.
Xeljanz 表現強勁,全球運營收入增長 29% 至 22 億美元。
We are very pleased with the continued positive uptake across all indications: rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, and we continue to launch psoriatic arthritis and ulcerative colitis in new markets.
我們對所有適應症的持續積極吸收感到非常高興:類風濕性關節炎、銀屑病關節炎和潰瘍性結腸炎,我們繼續在新市場推出銀屑病關節炎和潰瘍性結腸炎。
Looking at our Rare Disease business.
看看我們的罕見病業務。
VYNDAQEL continues to ramp up nicely in the U.S., following the May 2019 approval and launch for the treatment of ATTR-cardiomyopathy.
在 2019 年 5 月批准並推出用於治療 ATTR 心肌病之後,VYNDAQEL 在美國繼續穩步增長。
Overall, this first-of-its-kind medicine contributed $473 million in revenue in 2019.
總體而言,這種首創的藥物在 2019 年貢獻了 4.73 億美元的收入。
Our disease awareness efforts helped drive the diagnosis rate to 9% by the end of the fourth quarter compared with 1% prior to launch.
我們的疾病意識努力幫助將診斷率從發布前的 1% 提高到第四季度末的 9%。
As of the end of 2019, more than 9,000 patients have been diagnosed, more than 5,500 patients had received a prescription for VYNDAQEL and more than 3,000 patients had received the drug.
截至 2019 年底,已確診 9000 多名患者,5500 多名患者接受了 VYNDAQEL 的處方,3000 多名患者接受了該藥。
These numbers do not include approximately 100 patients who are still in the Early Access Program.
這些數字不包括大約 100 名仍處於早期訪問計劃中的患者。
Global Prevnar 13 revenues were up 3% operationally to $5.8 billion.
Global Prevnar 13 運營收入增長 3% 至 58 億美元。
The U.S. CDC also published its updated recommendation for immunocompetent adults aged 65 and older to Shared Clinical Decision Making in the November Morbidity and Mortality Weekly Report, highlighting that a patient can share the decision to vaccinate with PCV13 with a physician, physician's assistant, nurse practitioner or pharmacist.
美國疾病預防控制中心還在 11 月發病率和死亡率週報中發布了對 65 歲及以上免疫功能正常的成年人的更新建議,以共享臨床決策,強調患者可以與醫生、醫生助理、執業護士分享接種 PCV13 疫苗的決定或藥劑師。
Looking at our Sterile Injectables portfolio, our focus on manufacturing recovery is taking shape and beginning to have a positive impact on the top line in the U.S. We have made solid progress with remediation and modernization and expect continued improvement throughout 2020.
看看我們的無菌注射劑產品組合,我們對製造業復甦的關注正在形成,並開始對美國的收入產生積極影響。我們在整治和現代化方面取得了堅實的進展,預計整個 2020 年將繼續改善。
Of note, while global revenue from our Sterile Injectables portfolio declined 1% operationally for the full year, it increased 5% operationally during the fourth quarter.
值得注意的是,雖然我們無菌注射劑產品組合的全球收入在全年運營中下降了 1%,但在第四季度的運營中增長了 5%。
Additionally, more than 80% of our injectables portfolio is in stock today, and we anticipate this percentage will continue to increase in 2020.
此外,我們 80% 以上的注射劑產品組合今天都有庫存,我們預計這一比例將在 2020 年繼續增加。
Our global Biosimilars portfolio grew 22% operationally to $911 million for the full year.
我們的全球生物仿製藥產品組合全年運營增長 22%,達到 9.11 億美元。
This was driven largely by 70% growth in the U.S., thanks to the launch of RETACRIT and a gradual uptake of Inflectra.
由於 RETACRIT 的推出和 Inflectra 的逐步採用,這主要是由美國 70% 的增長推動的。
The growth in the U.S. was partially offset by a decline in international markets, driven mainly by Inflectra.
美國的增長被主要由 Inflectra 推動的國際市場下滑部分抵消。
We expect an additional contribution from biosimilars in 2020 with the launch of 3 oncology monoclonal antibody biosimilars.
我們預計 2020 年生物仿製藥將做出額外貢獻,推出 3 種腫瘤單克隆抗體生物仿製藥。
Last week, we announced the launches of ZIRABEV and Ruxience in the U.S. market.
上週,我們宣佈在美國市場推出 ZIRABEV 和 Ruxience。
And next month, we expect to launch TRAZIMERA.
下個月,我們預計將推出 TRAZIMERA。
All 3 products will be available at a substantially discounted price compared with their originator products.
與它們的原創產品相比,所有 3 款產品都將以大幅折扣價出售。
Full year revenues for our Upjohn business were down 16% operationally to $10.2 billion.
我們 Upjohn 業務的全年營業收入下降 16% 至 102 億美元。
The key headwind during the year was the advent of generic competition on Lyrica in the U.S., which was partially offset by 7% operational growth in China.
這一年的主要不利因素是美國 Lyrica 仿製藥競爭的出現,這部分被中國 7% 的運營增長所抵消。
The growth in China was driven primarily by Viagra and Celebrex as well as Lipitor in non-reimbursed channels, which constitutes significant market share in China.
中國的增長主要是由偉哥和西樂葆以及立普妥在非報銷渠道推動的,這在中國占據了重要的市場份額。
We are making good progress with the pre-integration planning for Upjohn's proposed combination with Mylan, which remains on track for mid-2020.
我們在 Upjohn 與 Mylan 的擬議合併的預整合計劃方面取得了良好進展,該計劃仍有望在 2020 年中期進行。
In December, we announced that former Pfizer Chairman, Ian Read, and current Pfizer director, James Kilts, will join the Viatris Board of Directors upon completion of the transaction.
12 月,我們宣布輝瑞公司前董事長 Ian Read 和輝瑞公司現任董事 James Kilts 將在交易完成後加入 Viatris 董事會。
We are also working closely with our counterparts of Mylan on the CFO selection process.
我們還在 CFO 選擇過程中與 Mylan 的同行密切合作。
We expect to announce the appointments of both the CFO and the third director by the end of this quarter.
我們預計將在本季度末宣布任命首席財務官和第三任董事。
We have great confidence in Viatris, which will combine Upjohn's strong commercial capabilities and iconic brands with Mylan's terrific pipeline.
我們對 Viatris 充滿信心,它將把 Upjohn 強大的商業能力和標誌性品牌與 Mylan 出色的管道相結合。
Turning now to R&D.
現在轉向研發。
We remain very pleased with the progress we are making with our pipeline.
我們仍然對我們在管道方面取得的進展感到非常滿意。
We are expecting key clinical readouts in 2020, several of which have the potential to make this an exciting year for patients hoping for new treatment options.
我們預計 2020 年會有關鍵的臨床數據,其中一些數據有可能讓希望獲得新治療選擇的患者成為激動人心的一年。
We anticipate sharing data from up to 15 proof-of-concept readouts with contributions from all our therapeutic areas as well as up to 10 pivotal study starts and 5 key pivotal study readouts.
我們預計與來自我們所有治療領域的貢獻的多達 15 個概念驗證讀數以及多達 10 個關鍵研究開始和 5 個關鍵關鍵研究讀數共享數據。
I will now highlight some of those expected events.
我現在將重點介紹其中一些預期事件。
We continue to expect our 2 event-driven Ibrance early breast cancer programs, PENELOPE-B and PALLAS to readout in late 2020 and early 2021, respectively.
我們繼續預計我們的兩個事件驅動的 Ibrance 早期乳腺癌項目 PENELOPE-B 和 PALLAS 將分別在 2020 年底和 2021 年初公佈。
If successful and following regulatory approval, these programs could double the number of patients eligible to benefit from Ibrance.
如果成功並獲得監管部門的批准,這些計劃可以使有資格從 Ibrance 受益的患者數量增加一倍。
The Phase 2 open-label single-arm anchor CRC study evaluating the efficacy and safety of the combination of Braftovi and Mektovi and cetuximab in patients with previously untreated BRAF V600E mutant metastatic colorectal cancer is currently ongoing.
2期開放標籤單臂錨定 CRC 研究評估 Braftovi 和 Mektovi 和西妥昔單抗聯合治療先前未治療的 BRAF V600E 突變轉移性結直腸癌患者的療效和安全性目前正在進行中。
Results from the study will be submitted for presentation at a medical congress in the second half of 2020.
該研究的結果將提交給 2020 年下半年的醫學大會。
For abrocitinib, our investigational JAK1 inhibitor for the treatment of moderate to severe atopic dermatitis, we look forward to sharing top line findings from the Phase 3 JADE compare trial in the coming months.
對於我們用於治療中度至重度特應性皮炎的研究 JAK1抑製劑 abrocitinib,我們期待在未來幾個月分享 JADE 3期比較試驗的主要結果。
Pending successful conclusion of the core Phase 3 studies, regulatory submission in the U.S. is projected for the third quarter of 2020, with subsequent markets following later in the year.
在成功完成第三階段核心研究之前,預計美國的監管提交時間為 2020 年第三季度,隨後的市場將在今年晚些時候推出。
This study is designed to assess the efficacy and safety of abrocitinib or dupilumab placebo in adults on background medicated topical therapy with moderate to severe atopic dermatitis.
本研究旨在評估 abrocitinib 或 dupilumab 安慰劑在成人中度至重度特應性皮炎背景藥物局部治療中的療效和安全性。
The study also has a key secondary endpoint but it is designed to assess the effect of -- on each severity of abrocitinib compared with dupilumab in adults with moderate to severe atopic dermatitis on background topical therapy.
該研究還有一個關鍵的次要終點,但它旨在評估在背景局部治療的中度至重度特應性皮炎成人中,abrocitinib 與 dupilumab 相比對每種嚴重程度的影響。
There are up to 5 proof-of-concept readouts expected in 2020 from our industry-leading immunokinase pipeline.
預計到 2020 年,我們行業領先的免疫激酶管道將提供多達 5 個概念驗證讀數。
Our hope is to advance several of these into Phase 3 trials.
我們希望將其中幾個推進到第三階段試驗。
These include: TYK2/JAK1 with potential POC readouts for psoriatic arthritis and for a topical formulation for psoriasis and atopic dermatitis; as well as an oral JAK3/TYK for vitiligo and oral TYK2 for psoriasis.
其中包括: TYK2/JAK1,具有潛在的 POC 讀數用於銀屑病關節炎和用於銀屑病和特應性皮炎的局部製劑;以及用於白癜風的口服 JAK3/TYK 和用於牛皮癬的口服 TYK2。
This is a great example of our unique strategy to purposefully match a molecule to a disease where we think it has the potential to make the most difference as well as the formulation that we believe has the potential to treat milder forms of disease.
這是我們獨特策略的一個很好的例子,即有目的地將分子與我們認為它有可能產生最大差異的疾病相匹配,以及我們認為有可能治療較輕疾病形式的配方。
Our gene therapy platform is advancing with promising Phase 1/2 hemophilia A data that is expected to support a Phase 3 start this year.
我們的基因治療平台正在推進有前景的 1/2 期血友病 A 期數據,預計將支持今年開始的第 3 期。
This would be our second gene therapy pivotal study following the ongoing hemophilia B Phase 3 study.
這將是我們繼正在進行的血友病 B 期 3 期研究之後的第二項基因治療關鍵研究。
In addition, our DMD gene therapy program is gathering additional robust patient data, building on the progress we served at the Parent Project Muscular Dystrophy conference last June.
此外,我們的 DMD 基因治療計劃正在收集更多可靠的患者數據,以我們在去年 6 月的父項目肌營養不良症會議上所取得的進展為基礎。
We are preparing for an expected POC in the first half of 2020 and the Phase 3 pivotal study start in second half of this year.
我們正在為 2020 年上半年的預期 POC 和今年下半年開始的第三階段關鍵研究做準備。
We look forward to successfully completing the Phase 3 studies for our Investigational 20-valent pneumococcal conjugate vaccine candidate in adults and remain on track to submit the Biologics License Application to the FDA by the end of this year.
我們期待成功完成我們的成人研究性 20 價肺炎球菌結合疫苗候選者的 3 期研究,並繼續按計劃在今年年底前向 FDA 提交生物製品許可申請。
Pfizer's candidate represents a potential significant advancement compared with the potential 15-valent.
與潛在的 15 價相比,輝瑞的候選人代表了潛在的重大進步。
If successful in Phase 3 and approved, the 5 additional serotypes may provide coverage against approximately 33% more strains that cause invasive pneumococcal disease in adults and 42% more strains causing the disease in infants in the United States.
如果在第 3 階段取得成功並獲得批准,另外 5 种血清型可能會覆蓋大約 33% 的導致成人侵襲性肺炎球菌疾病的菌株和 42% 的導致嬰兒疾病的菌株。
For our maternal vaccine for respiratory syncytial virus, RSV, we are preparing for an expected POC in the second quarter of 2020, followed by potentially swift progression to Phase 3. We look forward to sharing more updates on our pipeline during our upcoming Investor Day on March 31.
對於我們的呼吸道合胞病毒母體疫苗 RSV,我們正在為 2020 年第二季度的預期 POC 做準備,隨後可能迅速進入第 3 階段。我們期待在即將到來的投資者日期間分享更多關於我們管道的更新3 月 31 日。
In summary, we finished 2019 with strong momentum and we look forward to continuing that momentum in 2020.
總之,我們以強勁的勢頭結束了 2019 年,我們期待在 2020 年繼續保持這種勢頭。
During the year, we generated a solid financial performance, further advanced our strong R&D pipeline and took bold actions to reshape Pfizer into an innovation powerhouse that were built on our legacy of delivering breakthroughs that change patients' lives.
在這一年裡,我們取得了穩健的財務業績,進一步推進了我們強大的研發渠道,並採取了大膽的行動,將輝瑞重塑為一家創新強國,這建立在我們提供改變患者生活的突破的傳統之上。
Now I will turn it over to Frank to provide details on the quarter and our outlook for the remainder of 2020.
現在,我將把它交給弗蘭克,以提供有關本季度的詳細信息以及我們對 2020 年剩餘時間的展望。
Frank?
坦率?
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Thanks, Albert.
謝謝,阿爾伯特。
Good day, everyone.
今天是個好日子。
Now moving on to the financials.
現在轉到財務方面。
Fourth quarter 2019 revenues were $12.7 billion, down 8% operationally versus the year-ago quarter.
2019 年第四季度的收入為 127 億美元,在運營上比去年同期下降 8%。
Excluding the impact of the Consumer Healthcare business, revenue was down 1% operationally.
排除消費者保健業務的影響,運營收入下降了 1%。
Our Biopharmaceuticals Group business revenues were $10.5 billion, up 9% operationally versus the year-ago quarter, with strong operational growth in Ibrance, Eliquis, Xeljanz and VYNDAQEL and a second straight quarter of operational growth for our Hospital business, including our Sterile Injectables.
我們的生物製藥集團業務收入為 105 億美元,運營收入比去年同期增長 9%,Ibrance、Eliquis、Xeljanz 和 VYNDAQEL 的運營增長強勁,我們的醫院業務(包括我們的無菌注射劑)連續第二個季度實現運營增長。
Revenues for our Upjohn business in the fourth quarter decreased 32% operationally to $2.2 billion, with the primary year-over-year impact again being generic competition for Lyrica in the U.S. that began in July of 2019.
我們的 Upjohn 業務在第四季度的運營收入下降了 32% 至 22 億美元,主要的同比影響再次是 2019 年 7 月開始的美國 Lyrica 的仿製藥競爭。
Excluding the unfavorable impact of Lyrica in the U.S. and other recent product losses of exclusivity, fourth quarter 2019 revenues for Upjohn declined 6% operationally.
排除 Lyrica 在美國的不利影響以及其他近期產品的排他性損失,Upjohn 2019 年第四季度的運營收入下降了 6%。
I know Upjohn's business in China has been an area of focus and fourth quarter revenues for Upjohn declined 1% operationally.
我知道 Upjohn 在中國的業務一直是一個重點領域,Upjohn 第四季度的運營收入下降了 1%。
We saw the expected revenue declines for Lipitor and Norvasc in provinces where the volume-based procurement program has been implemented, and these declines were mostly offset by operational growth from products not impacted by the VBP program, including Celebrex and Viagra.
我們看到立普妥和諾華士在實施了基於數量的採購計劃的省份的預期收入下降,這些下降主要被不受 VBP 計劃影響的產品的運營增長所抵消,包括西樂葆和偉哥。
Adjusted cost of sales as a percentage of revenue was favorably impacted by the July completion of the Consumer Healthcare joint venture transaction with GSK, partially offset by the negative impact of foreign exchange and the Lyrica loss of exclusivity.
調整後的銷售成本佔收入的百分比受到 7 月份與 GSK 完成消費者保健合資交易的有利影響,但部分被外彙的負面影響和 Lyrica 的排他性損失所抵消。
In the fourth quarter, we recorded a $0.06 loss per share on a GAAP basis, which primarily due to a $2.6 billion asset impairment charge for Eucrisa and restructuring, purchase accounting and legal charges.
在第四季度,我們根據公認會計原則錄得每股虧損 0.06 美元,這主要是由於 Eucrisa 的 26 億美元資產減值費用以及重組、採購會計和法律費用。
Adjusted diluted EPS for the fourth quarter was $0.55 versus $0.63 in the year-ago quarter.
第四季度調整後的稀釋後每股收益為 0.55 美元,而去年同期為 0.63 美元。
The decrease was primarily due to lower revenues, again mainly due to the Lyrica LOE in the U.S. and higher operating expenses.
下降的主要原因是收入下降,這主要是由於美國的 Lyrica LOE 和較高的運營費用。
I want to point out that diluted weighted average shares outstanding declined by 281 million shares compared to the year-ago quarter, reflecting the impact of shares repurchased during 2018 and 2019 and partially offset by dilution related to share-based employee compensation programs.
我想指出的是,與去年同期相比,稀釋後的加權平均流通股減少了 2.81 億股,這反映了 2018 年和 2019 年回購股票的影響,部分被與基於股票的員工薪酬計劃相關的稀釋所抵消。
Finally, foreign exchange had a negative impact of $158 million or 1% on fourth quarter 2019 revenues and a $0.03 negative impact on adjusted diluted EPS compared to the year-ago quarter.
最後,與去年同期相比,外匯對 2019 年第四季度的收入產生了 1.58 億美元或 1% 的負面影響,對調整後的攤薄每股收益產生了 0.03 美元的負面影響。
As you can see on the chart, our 9% operational growth in the Biopharma business was driven by strong performance by Ibrance, Eliquis, Xeljanz, Xtandi, VYNDAQEL and Inlyta.
正如您在圖表中看到的,我們在生物製藥業務中 9% 的運營增長是由 Ibrance、Eliquis、Xeljanz、Xtandi、VYNDAQEL 和 Inlyta 的強勁表現推動的。
Moving on to 2019 financial guidance.
繼續 2019 年的財務指導。
As you can see on the chart, we met or exceeded all components of our 2019 financial guidance.
正如您在圖表中看到的,我們達到或超過了 2019 年財務指導的所有組成部分。
Now I want to highlight how our 2020 guidance compares to 2019 revenue and adjusted diluted EPS.
現在我想強調一下我們的 2020 年指引與 2019 年的收入和調整後的攤薄每股收益相比如何。
Starting on the left side of the slide, our 2019 results reflect partial year contributions from the Consumer Healthcare business segment, which we deconsolidated in the third quarter of 2019.
從幻燈片左側開始,我們 2019 年的業績反映了消費者醫療保健業務部門的部分年度貢獻,我們在 2019 年第三季度取消了合併。
Excluding $2.1 billion in revenues generated from the Consumer Healthcare business segment, total company 2019 revenues were $49.7 billion, and 2019 adjusted diluted EPS is $2.95.
不包括消費者保健業務部門產生的 21 億美元收入,公司 2019 年總收入為 497 億美元,2019 年調整後的攤薄每股收益為 2.95 美元。
For 2020, the adjusted diluted EPS guidance range reflects Pfizer's share of the Consumer Healthcare's joint venture's earnings that were generated in fourth quarter 2019 and will be reported in first quarter 2020 along with Pfizer's share of the JV's anticipated earnings for the first 3 quarters of 2020.
對於 2020 年,調整後的稀釋每股收益指導範圍反映了輝瑞在 2019 年第四季度產生的消費者保健合資企業收益中的份額,並將在 2020 年第一季度報告,以及輝瑞在合資企業 2020 年前三個季度的預期收益中的份額.
As you can see, the midpoint of our 2020 guidance range for revenues implies comparable performance to 2019 revenues after excluding the partial year contribution from Consumer Healthcare as well as an anticipated $200 million favorable impact from foreign exchange based on mid-January 2020 rates compared to last year.
如您所見,我們 2020 年收入指導範圍的中點意味著扣除消費者醫療保健的部分年度貢獻以及基於 2020 年 1 月中旬匯率的預期 2 億美元外匯有利影響後,2019 年收入的表現與去年。
Despite an anticipated $2.4 billion in LOE headwinds in 2020, we expect the midpoint of the revenue range to remain flat operationally, excluding Consumer Healthcare.
儘管預計 2020 年 LOE 將面臨 24 億美元的逆風,但我們預計收入範圍的中點在運營上將保持平穩,不包括消費者醫療保健。
Now let's go through the full details of our 2020 financial guidance for total company.
現在讓我們詳細了解我們對整個公司的 2020 年財務指導。
As we've said, we are expecting the close of the transaction between our Upjohn business and Mylan to be completed in mid-2020 so we are providing 3 sets of guidance: first, total company, which reflects our current construct of the Biopharma and Upjohn businesses and excludes any impact from the pending Upjohn combination with Mylan; second, new Pfizer, which is a full year pro forma view that reflects the impact of the pending Viatris transaction by removing Upjohn and including $12 billion in cash proceeds from Upjohn to new Pfizer and other transaction-related factors, such as transitional service agreement revenue; and third, Upjohn as a stand-alone business.
正如我們所說,我們預計我們的 Upjohn 業務和邁蘭之間的交易將在 2020 年年中完成,因此我們提供 3 套指導:第一,總體公司,這反映了我們目前對生物製藥的結構和Upjohn 的業務並排除 Upjohn 與 Mylan 的未決合併的任何影響;第二,新輝瑞,這是一個全年的預估視圖,通過移除 Upjohn 並將 Upjohn 的 120 億美元現金收益包括到新輝瑞和其他與交易相關的因素(如過渡服務協議收入)來反映未決的 Viatris 交易的影響;第三,Upjohn 作為一個獨立的企業。
All of these scenarios are based on a full year of revenues and expenses in 2020.
所有這些情景均基於 2020 年全年的收入和支出。
Beginning with total company, 2020 revenue guidance of $48.5 billion to $50.5 billion reflects anticipated continued strong momentum in our Biopharma business, primarily offset by the continued negative impact of product losses of exclusivity in our Upjohn business, primarily Lyrica in the U.S.
從公司總數開始,2020 年 485 億美元至 505 億美元的收入指導反映了我們生物製藥業務的預期持續強勁勢頭,主要被我們的 Upjohn 業務(主要是美國的 Lyrica)的排他性產品損失的持續負面影響所抵消。
Moving on to other elements of our 2020 financial guidance for total company.
繼續討論我們對整個公司的 2020 年財務指導的其他要素。
Compared with 2019 actual results, the midpoints of these ranges imply higher adjusted cost of sales as a percentage of revenues due to the continued impact from the Lyrica LOE, higher adjusted R&D expenses and higher adjusted other income, which reflects earnings from the Consumer Healthcare joint venture and lower adjusted SI&A expenses and adjusted diluted EPS.
與 2019 年的實際結果相比,這些範圍的中點意味著由於 Lyrica LOE 的持續影響,調整後的銷售成本佔收入的百分比較高,調整後的研發費用和調整後的其他收入較高,這反映了消費者保健聯合公司的收益風險並降低調整後的 SI&A 費用和調整後的攤薄每股收益。
In 2020, financial guidance for adjusted EPS assumes no new share repurchases, and we will focus instead on increasing the dividend and investing in the business during this period of growth.
2020年調整後每股收益的財務指引假設沒有新股回購,我們將在此增長期專注於增加股息和投資業務。
As a result, our guidance for adjusted diluted EPS assumes diluted weighted average shares outstanding of approximately 5.65 billion shares, which is approximately the same as 2019.
因此,我們對調整後攤薄每股收益的指引假設攤薄加權平均流通股約為 56.5 億股,與 2019 年大致相同。
Moving on to financial guidance for new Pfizer.
繼續為新輝瑞提供財務指導。
For the full year 2020, we now anticipate full year 2020 revenues between $40.7 billion and $42.3 billion, with the midpoint of the guidance range representing 8% operational growth as compared to 2019 Biopharma revenues, excluding Meridian and Mylan Japan and an improvement from our initial July targets.
對於 2020 年全年,我們現在預計 2020 年全年收入在 407 億美元至 423 億美元之間,與 2019 年生物製藥收入相比,指導範圍的中點代表 8% 的運營增長,不包括 Meridian 和 Mylan 日本,並且比我們最初的有所改善七月目標。
This guidance range excludes $600 million of contributions from Meridian, Pfizer's subsidiary and manufacturer of EpiPen and other auto-injector products as well as from the strategic collaboration with Mylan in Japan for the development, manufacturing and marketing of generic medicines.
該指導範圍不包括輝瑞(Pfizer)的子公司和 EpiPen 和其他自動注射器產品製造商 Meridian 的 6 億美元捐款,以及與日本邁蘭(Mylan)在仿製藥開發、製造和營銷方面的戰略合作。
Due to an organization realignment, both of these assets have shifted to Upjohn effective at the start of 2020.
由於組織調整,這兩項資產都已從 2020 年初開始轉移到 Upjohn。
Both Meridian and Mylan Japan will be reported in Pfizer's Upjohn business beginning in first quarter 2020.
從 2020 年第一季度開始,輝瑞的 Upjohn 業務將報告 Meridian 和 Mylan Japan。
We now anticipate full year 2020 adjusted IBT as a percentage of revenue of approximately 37%, also an improvement from July.
我們現在預計 2020 年全年調整後的 IBT 佔收入的百分比約為 37%,也比 7 月份有所改善。
We anticipate the midpoint of the guidance range for adjusted diluted EPS to be $2.30.
我們預計調整後的稀釋每股收益指導範圍的中點為 2.30 美元。
The operating cash flow guidance range remains approximately $11 billion to $12 billion.
經營現金流指導範圍仍約為 110 億至 120 億美元。
This EPS guidance reflects the $12 billion cash that Pfizer will receive upon the close of the combination of Upjohn with Mylan, which will be used to pay down debt during 2020.
該每股收益指引反映了輝瑞在 Upjohn 與 Mylan 合併後將獲得的 120 億美元現金,這些現金將用於在 2020 年償還債務。
As you can see, the midpoints for new Pfizer's 2020 revenue and adjusted IBT margin guidance have improved materially since our preliminary 2020 projections were presented in July in conjunction with the announcement of the proposed Mylan and Upjohn combination.
正如您所看到的,自從我們在 7 月公佈 2020 年初步預測以及宣布擬議的 Mylan 和 Upjohn 組合以來,輝瑞新的 2020 年收入和調整後的 IBT 利潤率指導的中點已顯著改善。
We have provided a bridge from our initial July targets to this current guidance on the bottom of the chart for clarity.
為了清晰起見,我們在圖表底部提供了從最初的 7 月目標到當前指導的橋樑。
Upon the close of the Mylan and Upjohn combination and once we become new Pfizer, you can expect the same level of detail in our 2020 guidance that we provided today for total company.
在 Mylan 和 Upjohn 合併完成後,一旦我們成為新的輝瑞,您可以期待我們今天為整個公司提供的 2020 年指南中的詳細程度相同。
Moving on to 2020 financial guidance for Upjohn.
繼續為 Upjohn 提供 2020 年財務指導。
For the full year 2020, we anticipate revenues of $8 billion to $8.5 billion, reflecting the continued negative impact of losses of exclusivity for products such as Lyrica in the U.S., which began facing multi-source generic competition in July 2019 and the expansion of the volume-based procurement program in China and reflecting the inclusion of revenues and expenses associated with Meridian and Mylan Japan.
對於 2020 年全年,我們預計收入將在 80 億美元至 85 億美元之間,這反映了 Lyrica 等產品在美國的排他性損失的持續負面影響,該產品於 2019 年 7 月開始面臨多源仿製藥競爭,以及擴大中國基於數量的採購計劃,反映了與 Meridian 和 Mylan Japan 相關的收入和支出。
We anticipate full year 2020 adjusted EBITDA for the Upjohn business of $3.8 billion to $4.2 billion.
我們預計 Upjohn 業務的 2020 年全年調整後 EBITDA 為 38 億美元至 42 億美元。
Other than the inclusion of revenues and expenses associated with Meridian and Mylan Japan, there are no operational changes to Upjohn's 2020 financial guidance compared with preliminary financial targets provided in July of 2019.
除了包含與 Meridian 和 Mylan Japan 相關的收入和費用外,與 2019 年 7 月提供的初步財務目標相比,Upjohn 的 2020 年財務指導沒有任何運營變化。
Again, we have provided a bridge from our initial July targets to this current guidance at the bottom of the chart.
同樣,我們在圖表底部提供了從最初的 7 月目標到當前指導的橋樑。
Moving on to key takeaways.
繼續討論關鍵要點。
Regarding 2019, we delivered a strong fourth quarter with our Biopharma business growing 9% operationally, which represents our go-forward business after the pending combination of Upjohn and Mylan.
關於 2019 年,我們實現了強勁的第四季度,我們的生物製藥業務在運營上增長了 9%,這代表了我們在 Upjohn 和 Mylan 的未決合併之後的前進業務。
We provided 2020 guidance ranges for total company, new Pfizer and Upjohn.
我們為整個公司、新輝瑞和 Upjohn 提供了 2020 年的指導範圍。
Importantly, we are projecting strong organic revenue growth for new Pfizer in 2020.
重要的是,我們預計新輝瑞在 2020 年將實現強勁的有機收入增長。
We accomplished key product and pipeline milestones since our previous quarterly update, and we returned $16.9 billion to shareholders in 2019 through a combination of dividends and share repurchases.
自上一季度更新以來,我們實現了關鍵產品和管道里程碑,並通過股息和股票回購相結合的方式在 2019 年向股東返還了 169 億美元。
Looking ahead, we remain committed to delivering attractive shareholder returns in 2020 and beyond.
展望未來,我們將繼續致力於在 2020 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。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Thanks, Frank and Albert, for those remarks.
謝謝弗蘭克和阿爾伯特的這些評論。
At this time, operator, can we please poll for questions?
這個時候,接線員,我們可以投票提問嗎?
Operator
Operator
(Operator Instructions) Your first question comes from Randall Stanicky from RBC Capital Markets.
(操作員說明)您的第一個問題來自 RBC Capital Markets 的 Randall Stanicky。
Randall S. Stanicky - MD of Global Equity Research & Lead Analyst
Randall S. Stanicky - MD of Global Equity Research & Lead Analyst
I have 2, 1 for Albert and 1 for Angela.
我有 2 個,1 個給 Albert,1 個給 Angela。
Albert, a couple of weeks ago, you called out $4.5 billion in enabling costs in SI&A with an opportunity to simplify.
阿爾伯特,幾週前,您在 SI&A 中提出了 45 億美元的支持成本,並有機會簡化。
So how do we think about the cost savings opportunity after you close Upjohn in terms of: number one, how much incremental cost savings do you see beyond what is built into the 37% margin?
那麼,在您關閉 Upjohn 之後,我們如何看待成本節約機會:第一,除了 37% 的利潤率之外,您還能看到多少增量成本節約?
And then number two, how much of that could hit back half 2020 versus 2021?
然後第二點,其中有多少可以在 2020 年上半年與 2021 年相比有所回落?
And then I have a follow-up after that for Angela.
然後我對安吉拉進行了跟進。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Okay.
好的。
I think you should -- how can he ask the question to Angela now?
我想你應該——他現在怎麼能問安吉拉這個問題?
He can get back.
他可以回來。
Okay.
好的。
All right.
好的。
So indeed, we have, this year, approximately $14.3 billion of SI&A and I will ask Frank to run the numbers in more details.
事實上,今年我們有大約 143 億美元的 SI&A,我會請弗蘭克更詳細地計算這些數字。
And as I said, $4.5 billion approximately of that is what we call enabling functions.
正如我所說,其中大約 45 億美元就是我們所說的啟用功能。
These are functions like finance, legal, HR, facilities that they are facilitating and enabling the core functions of our business to perform core functions.
這些是財務、法律、人力資源、設施等職能,它們正在促進並使我們業務的核心職能能夠履行核心職能。
I mean, R&D, that is discovering the products.
我的意思是,研發,就是發現產品。
Manufacturing, that is making them happen.
製造,這使它們發生。
And commercial, that is making them available to the patients.
商業化,就是讓患者可以使用它們。
We do believe that this $4.5 billion and actually approximately 10,000 people can be improved and we have plans to do so.
我們確實相信這 45 億美元,實際上大約 10,000 人可以得到改善,我們有計劃這樣做。
In the current guidance and I will ask Frank to comment, there is a part, a small part of that cost opportunity saving already incorporated.
在當前的指導中,我將請弗蘭克發表評論,其中一部分,一小部分已經納入了成本機會節省。
And in 2021 will be a much bigger part.
到 2021 年,這將是一個更大的部分。
So Frank?
所以弗蘭克?
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
So Randall, just let me run the numbers, which is if you look at 2019 actual SI&A, for example, we spent about $14 billion as a company.
所以蘭德爾,讓我計算一下數字,如果你看看 2019 年的實際 SI&A,例如,我們作為一家公司花費了大約 140 億美元。
Obviously, that $4.5 billion that Albert alluded to in that $14 billion.
顯然,阿爾伯特在這 140 億美元中提到的 45 億美元。
If you look at our 2020 guidance for SI&A, the range is $12 billion to $13 billion, midpoint $12.5 billion.
如果您查看我們對 SI&A 的 2020 年指導,範圍為 120 億美元至 130 億美元,中點為 125 億美元。
$12.5 billion from $14 billion is a decline of $1.5 billion.
125 億美元從 140 億美元減少了 15 億美元。
Now roughly half of that is Consumer because we went from consolidating Consumer to equity accounting on Consumer once the deal closed in July 31 of 2019.
現在其中大約一半是消費者,因為一旦交易於 2019 年 7 月 31 日結束,我們就從合併消費者轉向了消費者權益會計。
The remaining half is really operational savings across the company, including part of the 4 -- including some of the $4.5 billion that Albert alluded to.
剩下的一半實際上是整個公司的運營節省,包括 4 的一部分——包括 Albert 提到的 45 億美元中的一部分。
And that obviously helped contribute to the IBT as a percentage of revenue, improving from 35%, from the mid-30s to 37%.
這顯然有助於提高 IBT 佔收入的百分比,從 30 年代中期的 35% 提高到 37%。
And then to Albert's point, obviously, what we're doing now is working on further improvements that would obviously positively impact the SI&A and that would flow to the bottom line.
然後到阿爾伯特的觀點,顯然,我們現在正在做的工作是進一步改進,這顯然會對 SI&A 產生積極影響,並且會流向底線。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Great.
偉大的。
Thanks, Albert and Frank.
謝謝,艾伯特和弗蘭克。
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。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Great.
偉大的。
Just had 3 quick product ones.
剛剛有 3 個快速產品。
The first was on VYNDAQEL.
第一個是在 VYNDAQEL 上。
Seems like a nice step-up in all your patient metrics.
在您的所有患者指標中,這似乎是一個不錯的進步。
Seems like all those basically doubled or tripled from 3Q.
似乎所有這些基本上都是第三季度的兩倍或三倍。
Can you help bridge those figures with the sequential sales ramp we saw, which wasn't quite as dramatic?
您能否幫助將這些數字與我們看到的連續銷售增長聯繫起來,這並不那麼引人注目?
The second question I had was on Ibrance.
我的第二個問題是關於 Ibrance。
Just elaboration there in terms of what drove the revised time lines for PALLAS.
只是詳細說明了推動 PALLAS 修訂時間表的原因。
And have you taken another interim look at the data at this point?
此時您是否對數據進行了另一次臨時研究?
And then finally, on tanezumab, just an update in terms of what the status and outlook is for that product at this point.
最後,關於 tanezumab,只是關於該產品目前的狀態和前景的更新。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Very good.
很好。
Thank you very much.
非常感謝。
I will ask Angela to address the VYNDAQEL and tanezumab questions, and then I will say a few words about Ibrance.
我會請安吉拉解決 VYNDAQEL 和 tanezumab 的問題,然後我會談談 Ibrance。
And maybe I will ask Mikael to chime in.
也許我會請 Mikael 插話。
Please.
請。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
So thanks for the question.
所以謝謝你的問題。
And certainly, we are pleased with the increased diagnosis, prescription as well as the numbers of patients that are receiving VYNDAQEL.
當然,我們對增加的診斷、處方以及接受 VYNDAQEL 的患者數量感到滿意。
As you said, our diagnosis now is up to about 9%.
正如你所說,我們現在的診斷率高達9%左右。
The ability for patients to receive prescription is up to about 64% of those that are diagnosed.
患者接受處方的能力高達被診斷患者的 64%。
And those that are receiving medications are around 35% of those that are diagnosed.
那些正在接受藥物治療的人大約是被診斷出的人的 35%。
So -- and every quarter, since we've been reporting this, we've been seeing some nice increases.
所以 - 每個季度,自從我們報告這一點以來,我們都看到了一些不錯的增長。
So we're certainly pleased with that.
所以我們當然對此感到高興。
I think in terms of just the sort of the commensurate alignment with the actual net sales numbers, I think that there are -- obviously, there -- every single day, this is a dynamic situation.
我認為,就與實際淨銷售額的匹配程度而言,我認為每天都有——顯然,那裡——這是一個動態的情況。
And the number and the proportion of patients, whether they are Medicare and commercial lives, those are changing.
而患者的數量和比例,無論是醫療保險還是商業生活,都在發生變化。
And so the gross to net of those are going to affect, I think, what you see on a net sales basis.
因此,我認為,這些總淨額將影響您在淨銷售額基礎上看到的情況。
So I think that we are watching and really focused on driving diagnosis and ensuring that as many patients can get on these drugs as possible.
所以我認為我們正在觀察並真正專注於推動診斷並確保盡可能多的患者能夠使用這些藥物。
And we're starting to see some really nice pickup.
我們開始看到一些非常好的皮卡。
But I think that it's still a very dynamic situation because we're really relatively new in this process.
但我認為這仍然是一個非常動態的情況,因為我們在這個過程中確實相對較新。
So we'll continue to monitor and should expect to see some quarter-to-quarter changes in terms of net sales.
因此,我們將繼續監控並預計會看到淨銷售額的一些季度變化。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
And obviously, the new patients are contributing disproportional because they are in fewer months of treatment in terms of sales.
顯然,新患者的貢獻不成比例,因為他們在銷售方面的治療月份更少。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Right.
正確的。
And then your second question was on tanezumab.
然後你的第二個問題是關於 tanezumab。
So we're really pleased that in December of 2019, we completed our U.S. submission of tanezumab.
因此,我們非常高興在 2019 年 12 月,我們完成了 tanezumab 在美國的提交。
And we are also pursuing regulatory submissions in the EU and in Japan.
我們還在歐盟和日本尋求監管提交。
This submission was done in close collaboration with the FDA, and it includes the 2.5 milligram in moderate-to-severe osteoarthritis patients.
該提交是與 FDA 密切合作完成的,其中包括中度至重度骨關節炎患者的 2.5 毫克。
So at this moment in time, we're awaiting acceptance of this filing.
因此,此時此刻,我們正在等待接受此申請。
But we see significant potential of tanezumab in osteoarthritis, so we're really excited about this filing, and particularly, because we're in a time where non-opioid solutions are very, very much needed for these patients.
但我們看到了 tanezumab 在骨關節炎中的巨大潛力,所以我們對這份申請感到非常興奮,特別是因為我們正處於這些患者非常非常需要非阿片類藥物解決方案的時代。
If you look at the market potential, today, there are about 27 million Americans that suffer from osteoarthritis, and 11 million of those have moderate-to-severe OA.
如果你看一下市場潛力,今天大約有 2700 萬美國人患有骨關節炎,其中 1100 萬人患有中度至重度 OA。
80% of those 11 million people have tried and failed 3 or more analgesics.
在這 1100 萬人中,80% 的人嘗試了 3 種或更多的鎮痛劑,但都失敗了。
So that tells us that there is just a huge amount of unmet need in this patient population.
因此,這告訴我們,在這個患者群體中只有大量未滿足的需求。
Patients are cycling through a number of pain medications.
患者正在使用多種止痛藥。
And there just is an incredible need for new options, and this is where we think tanezumab can really fill an unmet need.
對新選擇的需求令人難以置信,這就是我們認為 tanezumab 可以真正滿足未滿足需求的地方。
It has the potential to become the first-in-class non-opioid treatment for these patients, and we eagerly await the acceptance of this file from the FDA.
它有可能成為這些患者的一流非阿片類藥物治療,我們熱切地等待 FDA 接受該文件。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you.
謝謝你。
Now let me address the question on Ibrance.
現在讓我來談談關於 Ibrance 的問題。
The expected completion of the study slipped a little bit a few weeks actually.
該研究的預期完成時間實際上推遲了幾個星期。
It was at the end of '19 -- excuse me, at the end of '20, and now it's moved in the very beginning of '21.
那是在 19 年末——對不起,在 20 年末,現在它在 21 年一開始就移動了。
The only reason of this is that the events are not coming at the pace that we had forecasted and expected.
唯一的原因是事件沒有按照我們預測和預期的速度發生。
So another means, people are not progressing into their disease.
因此,另一種方法是,人們並沒有發展成他們的疾病。
I don't think we can draw any conclusions if that means good news or bad news.
如果這意味著好消息或壞消息,我認為我們無法得出任何結論。
I think it's the structure of the data.
我認為這是數據的結構。
We don't know if the people aren't progressing equally in the 2 arms or they aren't progressing in the treatment arm.
我們不知道人們是否在 2 組中沒有同樣的進展,或者他們在治療組中沒有進展。
That remains to be seen when we unblind the data.
當我們揭開數據的盲點時,這還有待觀察。
As regards to your question if there was an interim analysis, there was not an interim analysis, so haven't seen any interim analysis.
至於你的問題是否有中期分析,沒有中期分析,所以沒有看到任何中期分析。
There will be an interim analysis, but we do not expect that -- the most likely scenario is that the study will continue when this interim analysis comes.
將進行中期分析,但我們預計不會——最有可能的情況是,當中期分析到來時,研究將繼續進行。
The study was designed to come to full completion.
該研究旨在全面完成。
And the criteria that we have set to stop for efficacy in the interim study are very, very high.
我們在中期研究中設定的停止有效性的標準非常非常高。
So it's not impossible, but this will happen.
所以這不是不可能的,但這會發生。
But most likely scenario, it is that as we had planned that the study will come to completion.
但最有可能的情況是,正如我們計劃的那樣,這項研究將會完成。
At the end of it, this is what will happen.
最後,這就是將要發生的事情。
But we are very -- we still remain very, very encouraged and optimistic about Ibrance.
但我們非常 - 我們仍然對 Ibrance 感到非常非常鼓舞和樂觀。
Of course, it's a Phase 3, you never know what will be.
當然,這是第三階段,你永遠不知道會是什麼。
But all the science behind it is supporting that we could have a positive outcome.
但它背後的所有科學都支持我們可以取得積極的成果。
And I will ask actually Mikael to make a few comments on the science and what does this mean.
我實際上會請 Mikael 對科學以及這意味著什麼發表一些評論。
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
I'll just punctuate a few things that Albert described so well, full aspect of why we are very excited and optimistic about the science and clinical data to predict a potential positive outcome for the discussed PALLAS study.
我將強調 Albert 描述得如此出色的幾件事,全面說明為什麼我們對科學和臨床數據感到非常興奮和樂觀,以預測所討論的 PALLAS 研究的潛在積極結果。
As you know, first of all, that the CDK4/6 inhibitor, Ibrance, converge with estrogen receptor drugs to stop cancer cells or breast cancer cells to divide.
如您所知,首先,CDK4/6 抑製劑 Ibrance 與雌激素受體藥物會聚以阻止癌細胞或乳腺癌細胞分裂。
We've shown that in the PALOMA-2 and 3 studies, and more recently, we reported that we could reproduce data direction in real-world evidence based on real-world data from Flatiron and other databases.
我們已經在 PALOMA-2 和 3 研究中證明了這一點,最近,我們報告說,我們可以根據來自 Flatiron 和其他數據庫的真實數據在真實世界證據中重現數據方向。
And this is noteworthy, including also overall survival data, again, showing in medical practice the importance of these drugs.
值得注意的是,還包括總體生存數據,再次顯示了這些藥物在醫療實踐中的重要性。
Three, the PALLET study that looked at ability of palbociclib Ibrance to stop dividing of estrogen receptor positive breast cancer showed that this mechanism was very well operating in a powerful way.
三,研究 palbociclib Ibrance 停止雌激素受體陽性乳腺癌分裂能力的 PALLET 研究表明,這種機制以一種強有力的方式運作良好。
And finally, let me remind you that other agents that act on estrogen receptor positive breast cancers and converge with palbociclib such as tamoxifen and aromatase inhibitors all were initially developed in metastatic cancer and did very well in adjuvant treatment in early breast cancer.
最後,讓我提醒您,其他作用於雌激素受體陽性乳腺癌並與 palbociclib 融合的藥物,例如他莫昔芬和芳香酶抑製劑,最初都是在轉移性癌症中開發的,並且在早期乳腺癌的輔助治療中效果很好。
So these 4 observations and others makes us continue to be excited and very optimistic.
因此,這 4 個觀察結果和其他觀察結果使我們繼續感到興奮和非常樂觀。
And as Albert alluded to, a relatively small change in projected trial is based on a trial that actually started 4.5 years ago.
正如 Albert 所暗示的那樣,預計試驗的一個相對較小的變化是基於 4.5 年前實際開始的試驗。
And it is quite common that in the final 12 months or so, minor changes in enrollment rate and process planning for study reports can affect the trial.
在最後 12 個月左右的時間裡,入學率和研究報告流程計劃的微小變化可能會影響試驗,這是很常見的。
But with all of this, you can hear we remain encouraged, enthusiastic about what Ibrance can offer for adjuvant treatment of breast cancer.
但有了這一切,你可以聽到我們仍然受到鼓舞,對 Ibrance 可以為乳腺癌的輔助治療提供什麼充滿熱情。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Great.
偉大的。
Thanks for the helpful context, Mikael.
感謝您提供有用的背景信息,Mikael。
Operator
Operator
Your next question comes from Terence Flynn from Goldman Sachs.
您的下一個問題來自高盛的 Terence Flynn。
Terence C. Flynn - MD
Terence C. Flynn - MD
Maybe just 2 product ones from me.
也許我只有 2 個產品。
Was wondering if you can talk about Ibrance rest of world dynamics.
想知道您是否可以談論 Ibrance 世界其他地區的動態。
Any specific headwinds this quarter and how to think about the trajectory into end of this year.
本季度的任何具體逆風以及如何考慮到今年年底的軌跡。
And then for Xeljanz, was wondering if you can give us a split of sales by indication and if you're seeing any impact in RA from the launch of AbbVie's RINVOQ on either share price.
然後對於 Xeljanz,想知道您是否可以通過指示給我們分配銷售額,以及您是否看到 AbbVie 的 RINVOQ 對任一股價的推出對 RA 有任何影響。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very, very much.
非常非常感謝你。
So Angela?
所以安吉拉?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Sure.
當然。
So first off, on Ibrance, we continue to see good growth and strong growth ex U.S., but probably 2 factors that are tempering the net sales, as you saw in Q4.
因此,首先,在 Ibrance 上,我們繼續看到美國以外的良好增長和強勁增長,但可能有兩個因素正在緩和淨銷售額,正如您在第四季度看到的那樣。
The first is pricing, and that continues to be something that we work hard at, especially in the EU to gain access for our product in Europe.
首先是定價,這仍然是我們努力的方向,尤其是在歐盟,以獲取我們產品在歐洲的使用權。
And the second is class growth.
第二個是階級增長。
So if you look at the class growth of the CDK class through the quarters, that has increased, but over the last quarter, it has tempered and it's sort of sitting at around a 35% CDK class growth right now -- class share.
因此,如果你看一下整個季度 CDK 課程的班級增長情況,它有所增加,但在上個季度,它有所緩和,目前 CDK 班級增長率約為 35%——班級份額。
But within that, the -- Ibrance still has a very, very high product share in the 80s.
但在這其中,--Ibrance 在 80 年代仍然擁有非常非常高的產品份額。
So I think it's pointing out to us the fact that there's still opportunity for us to grow and that growing the CDK class is going to be an area of tremendous focus for us ex U.S. in 2020 and beyond.
因此,我認為它向我們指出了這樣一個事實,即我們仍有成長的機會,並且在 2020 年及以後,發展 CDK 課程將成為我們除美國以外的一個非常關注的領域。
Your second question was around Xeljanz.
你的第二個問題是關於 Xeljanz 的。
And so on Xeljanz, again, we continue to see excellent growth in Xeljanz.
等 Xeljanz 再一次,我們繼續看到 Xeljanz 的出色增長。
In fact, despite the fact that you only see the sort of 1% net sales growth in Q4, I'll point out that globally, full year, we had 29% growth of Xeljanz, which is one of the highest of all of our core brands here at Pfizer in our entire portfolio.
事實上,儘管你在第四季度只看到了 1% 的淨銷售額增長,但我要指出的是,在全球範圍內,全年,我們的 Xeljanz 增長了 29%,這是我們所有產品中增長最快的之一輝瑞的核心品牌在我們的整個產品組合中。
Q4, we saw 23% prescription growth.
第四季度,我們看到了 23% 的處方增長。
And this prescription growth was driven by extremely strong performance in rheumatoid arthritis, which really was not impacted by the label changes.
這種處方增長是由類風濕性關節炎的極強表現推動的,這實際上並沒有受到標籤變化的影響。
And we still continue to see strong growth in ulcerative colitis, even though here was the biggest label change.
我們仍然繼續看到潰瘍性結腸炎的強勁增長,儘管這是最大的標籤變化。
And so physicians did have to adjust the way that they were prescribing Xeljanz.
因此,醫生確實不得不調整他們開 Xeljanz 的方式。
But we expect this growth to continue because we have excellent momentum and confidence in prescribing from our physicians.
但我們預計這種增長將繼續下去,因為我們對醫生開處方有極好的動力和信心。
We have significant unmet need, and we have greatly improved access.
我們有大量未滿足的需求,並且我們大大改善了訪問。
And this access is, in fact, what drove the 1% net sales in Q4.
事實上,這種訪問是推動第四季度淨銷售額增長 1% 的原因。
There was a -- in Q4 of '18, we saw an inventory build at the end of the year, which didn't happen in Q4 '19.
在 18 年第四季度,我們看到年底庫存增加,而這在 19 年第四季度沒有發生。
So that was one of the reasons that affected our Q4 performance in '19.
這就是影響我們在 19 年第四季度業績的原因之一。
And then also, and more importantly, throughout the course of 2019, we gained significant access.
然後,更重要的是,在整個 2019 年期間,我們獲得了重要的訪問權限。
In fact, we added 59 million incremental lives through contracting.
事實上,我們通過承包增加了 5900 萬條生命。
And it's because of the timing of when these contracts were signed or renewed that drove the subsequent impact of rebates.
正是因為這些合同簽署或續籤的時間導致了回扣的後續影響。
And this sort of came to a head and sort of disproportionately affected us in Q4 of '19.
這種情況在 19 年第四季度達到了頂峰,對我們產生了不成比例的影響。
So I think stepping back, we're really pleased with the access that we do have in Xeljanz.
所以我認為退後一步,我們對我們在 Xeljanz 中擁有的訪問權限感到非常滿意。
And since it was launched 8 years ago, this is the most favorable access situation that we've ever had, which is very important when it comes to our ability to compete with RINVOQ.
而且自從 8 年前推出以來,這是我們有史以來最有利的訪問情況,這對於我們與 RINVOQ 競爭的能力非常重要。
You asked a question around RINVOQ.
你問了一個關於 RINVOQ 的問題。
Just to sort of put into perspective, I think that we are excited about having another competitor help drive the growth of the JAK class in all of our indications.
換個角度來看,我認為我們很高興有另一個競爭對手在我們所有的跡像中幫助推動 JAK 類的增長。
And that being said, Xeljanz still enjoys a lion -- a leading market share, especially in RA where we have more than 15% of the market share of the entire class.
話雖如此,Xeljanz 仍然享有領先的市場份額,尤其是在 RA 中,我們擁有整個班級 15% 以上的市場份額。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Great.
偉大的。
Thank you very much, Angela.
非常感謝你,安吉拉。
Operator
Operator
Your next question comes from Umer Raffat from Evercore.
您的下一個問題來自 Evercore 的 Umer Raffat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
First, Albert, if I may, what are you hearing on a possible upcoming rule on IPI?
首先,Albert,如果可以的話,您對即將出台的 IPI 規則有何看法?
There's a lot of press that companies have been notified by White House.
有很多媒體稱公司已收到白宮通知。
I was curious what you know about it and if it's something we should be very concerned about.
我很好奇你對它了解多少,如果這是我們應該非常關心的事情。
Mikael, 2 quick -- one quick one for you on the DMD gene therapy for a minute.
Mikael,快 2 分鐘 - 為您提供一分鐘的 DMD 基因治療。
You mentioned there's a proof-of-concept coming.
您提到即將進行概念驗證。
My question is, have there been additional protocol-driven pauses in enrollment?
我的問題是,是否有額外的協議驅動的註冊暫停?
And I ask because recall when the first SAE and acute kidney injury happened, the trial was paused.
我之所以問,是因為回憶起第一次 SAE 和急性腎損傷發生時,試驗被暫停了。
And I'm curious, has anything like that happened again?
我很好奇,類似的事情又發生了嗎?
And then finally, Frank, maybe just quickly on SI&A line.
最後,弗蘭克,也許很快就會在 SI&A 線上。
I know it's a little higher than consensus, but technically, year-over-year versus 4Q '18, it wasn't that much higher, but I also realize 4Q '18 had some Consumer.
我知道這比共識高一點,但從技術上講,與 18 年第四季度相比,同比並沒有高多少,但我也意識到 18 年第四季度有一些消費者。
Maybe if you could just tell us about your holiday party.
也許你能告訴我們你的節日聚會。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
All right.
好的。
So let me start with the IPI.
那麼讓我從 IPI 開始。
We have not received any notification on that.
我們沒有收到任何通知。
So there is no news from our side other than what we read on the newspaper.
因此,除了我們在報紙上看到的消息外,沒有來自我們這邊的消息。
So Mikael?
所以米凱爾?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes.
是的。
Just to remind you, we shared at the PPMD conference mid of last year update on 6 patients dosed with our DMD gene therapy that showed encouraging data on expression in muscle fibers amount to microdystrophin.
提醒您一下,我們在去年年中的 PPMD 會議上分享了 6 名接受 DMD 基因治療的患者的最新情況,這些數據顯示令人鼓舞的肌肉纖維表達數據相當於微肌營養不良蛋白。
And on some of the patients, we had also an opportunity to report the encouraging trends on functional outcomes.
對於一些患者,我們還有機會報告功能結果的令人鼓舞的趨勢。
We have dosed additional patients since then, and we continue to gather experience on efficacy, safety and clinical management that are incorporated in the procedures, how we manage these patients going forward.
從那時起,我們已經給更多的患者用藥,我們將繼續收集納入程序的療效、安全性和臨床管理方面的經驗,以及我們未來如何管理這些患者。
We plan to conclude Phase 2 this spring.
我們計劃在今年春天結束第二階段。
And based on current data and insights, we are planning to start Phase 3, of course, pending regulatory dialogues later this year, as indicated in Albert's opening remarks.
根據當前的數據和見解,我們計劃啟動第 3 階段,當然,正如 Albert 的開場白所述,在今年晚些時候進行監管對話。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
All right.
好的。
Frank, maybe you want to tell us about the holiday party.
弗蘭克,也許你想告訴我們關於節日聚會的事。
I was not invited.
我沒有被邀請。
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Sure.
當然。
Yes.
是的。
I wasn't invited either, so maybe Umer was at the party.
我也沒有被邀請,所以也許 Umer 參加了聚會。
Let me run the numbers, and then I'll explain what happened.
讓我計算一下數字,然後我會解釋發生了什麼。
So for the quarter, SI&A all-in was about $4.1 billion.
因此,本季度,SI&A 的總投資額約為 41 億美元。
It was up about 4% operationally, $100 million, give or take, from the prior year quarter.
與去年同期相比,它的運營增長了約 4%,達到了 1 億美元。
What really drove that was increased investment behind some of our brands, some of our oncology products, some of our launch products like VYNDAQEL and some increased investment in emerging markets, but it was really investment in terms of being -- supporting our brands.
真正推動我們對一些品牌、我們的一些腫瘤產品、我們的一些推出產品(如 VYNDAQEL)以及對新興市場的一些增加投資的投資增加,但它確實是在支持我們的品牌方面的投資。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes.
是的。
Thank you, Mikael.
謝謝你,米凱爾。
And just to make a comment, we are very, very diligent in the way that we allocate capital.
只是為了發表評論,我們在分配資金的方式上非常非常勤奮。
And we are -- when we have opportunities to put in promotional money so we can have a very strong start, we do it.
而且我們 - 當我們有機會投入促銷資金以便我們可以有一個非常好的開端時,我們就會這樣做。
And we take those money usually by being very diligent in the way that we control the indirect expense.
我們通常通過非常勤奮地控制間接費用的方式來拿這些錢。
I have been very clear but direct.
我說得很清楚但很直接。
We think direct is a very clear distinction in our mind.
我們認為直接在我們的腦海中是一個非常明顯的區別。
So when it comes to things like the overheads and things that they are not affecting directly the business results, we are very, very tough.
因此,當涉及諸如間接費用之類的事情以及它們不會直接影響業務結果的事情時,我們非常非常強硬。
And when it comes to areas that the investments can affect business results, we are creative and generous.
當談到投資可能影響業務成果的領域時,我們富有創造力和慷慨。
So that's what you saw here.
這就是你在這裡看到的。
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
And these were clearly direct expenses.
這些顯然是直接費用。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
And these are all direct expenses.
而這些都是直接費用。
And the same, by the way, although you didn't ask, comes to R&D.
順便說一句,儘管您沒有問,但同樣涉及到研發。
Right now, we are increasing R&D investments, but we are increasing R&D investments only for programs, only for projects.
目前,我們正在增加研發投資,但我們只為項目增加研發投資,只針對項目。
We are not increasing infrastructure.
我們不會增加基礎設施。
We're not increasing research centers.
我們不會增加研究中心。
At large, we maintain a very strong presence there and we keep that very strong.
總的來說,我們在那裡保持非常強大的存在,並且我們保持非常強大。
But what is driving the increased R&D, it is more Phase 3 or Phase 2 studies.
但推動研發增加的是更多的第 3 階段或第 2 階段研究。
It's very clear.
很清楚。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Right.
正確的。
Thank you.
謝謝你。
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 Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
Yes.
是的。
So I have 3 questions, please.
所以我有3個問題,拜託。
First, Albert, could you discuss why Pfizer decided not to repurchase shares in 2020?
首先,Albert,您能否談談輝瑞公司決定在 2020 年不回購股票的原因?
And then maybe, Frank, you can comment about -- comment on how we should think about the EPS implications when we consider your guidance relative to consensus, which had assumed some share repurchase.
然後也許,弗蘭克,你可以評論 - 當我們考慮你的相對於共識的指導時,我們應該如何考慮每股收益的影響,這假設了一些股票回購。
Second, regarding the opportunity to rationalize the $4.5 billion in cost, can you just give us a sense for what percentage reduction is reasonable to assume a few years out?
其次,關於使 45 億美元成本合理化的機會,您能否告訴我們,假設幾年後減少多少百分比是合理的?
I was guessing maybe 20%, but I just don't know what's reasonable.
我猜可能是 20%,但我就是不知道什麼是合理的。
And then third, regarding the transfer of $600 million in revenue to Upjohn, does that change the economics that Pfizer will receive as part of the exit to Mylan?
第三,關於將 6 億美元的收入轉移給 Upjohn,這是否會改變輝瑞作為退出邁蘭的一部分所獲得的經濟效益?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes.
是的。
And I think basically all questions can be answered by Frank.
而且我認為基本上所有問題都可以由弗蘭克回答。
I would just make some introductory comments.
我只想做一些介紹性評論。
The reason why in our capital allocation, we are allocating right now money to increase the dividend and also to invest in our business all the OpEx to modernize our -- all the CapEx to modernize our facilities.
在我們的資本配置中,我們現在分配資金以增加股息並投資於我們的業務所有運營支出以使我們的現代化 - 所有資本支出以使我們的設施現代化。
The reason why we don't do right now share repurchases, it is because we want to make sure that we maintain very strong firepower to invest in the business.
我們現在不做股票回購的原因,是因為我們想確保我們保持非常強大的火力來投資這項業務。
The past was a very different Pfizer.
過去是一個非常不同的輝瑞。
The past of the last decade had to deal with declining of revenues, constant declining of revenues.
過去十年的過去不得不應對收入的下降,收入的不斷下降。
And we had to do what we had to do even if that was financial engineering, purchasing back ourselves.
我們必須做我們必須做的事情,即使那是金融工程,買回我們自己。
We couldn't invest them and create higher value.
我們無法投資它們並創造更高的價值。
Now it's a very different situation.
現在情況完全不同了。
We are a very different company.
我們是一家非常不同的公司。
The company is going to have best-in-class top line growth, revenue story starting from now from the separation of Upjohn in the middle of the year, from the expected separation of Upjohn in the middle of the year.
該公司將從現在開始,從年中分離 Upjohn 開始,從今年年中分離 Upjohn 開始,實現一流的收入增長和收入增長。
And we do not need.
而我們不需要。
We can organically grow EPS.
我們可以有機地增長EPS。
As you can see, all our projections on EPS this year are organically, no share repurchases, but we can use the capital to invest in good Phase 2, Phase 3 assets that could build our pipeline.
如您所見,我們今年對每股收益的所有預測都是有機的,沒有股票回購,但我們可以利用資金投資於可以建立我們管道的良好的第 2 階段、第 3 階段資產。
So this is the strategy behind it.
所以這就是它背後的策略。
Now let me ask Frank to run the numbers.
現在讓我請弗蘭克計算數字。
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
So David, now all I'll do is I don't want to duplicate anything Albert said.
所以大衛,現在我要做的就是我不想重複阿爾伯特所說的任何話。
I'll just add a couple of things on the share repurchases.
我將在股票回購中添加一些內容。
One, we also announced a dividend increase in December, so obviously, we continue to deploy capital in the area of dividends, which we think is important to our investment thesis, and that's something obviously, as we go forward, we'll continue to look at.
一,我們還在 12 月宣布增加股息,所以很明顯,我們繼續在股息領域部署資本,我們認為這對我們的投資主題很重要,這很明顯,隨著我們的前進,我們將繼續看著。
And then obviously, our 2020 guidance assumes no repurchases.
然後很明顯,我們的 2020 年指導假設沒有回購。
So when you look at the improvement, which is material in terms of the midpoint versus what we did back in July, none of that is coming from share repurchases.
因此,當您查看改進時,就中點而言,與我們在 7 月份所做的相比,這是重要的,這一切都不是來自股票回購。
Let me answer your other couple of questions.
讓我回答你的其他幾個問題。
On the $600 million transfer to Upjohn and does that change any of the economics, let me kind of -- let me give some context on this, which is, one, nothing has been decided yet.
關於向 Upjohn 轉移 6 億美元,這是否會改變任何經濟學,讓我有點 - 讓我給出一些背景信息,也就是說,還沒有任何決定。
We are still in negotiations with Mylan on those 2 businesses and whether or not they will transfer to Viatris upon close.
我們仍在與 Mylan 就這兩項業務進行談判,以及他們是否會在關閉後轉移到 Viatris。
If -- by the way, if we don't come to an agreement, those businesses would remain with new Pfizer.
如果——順便說一句,如果我們不達成協議,這些業務將留在新輝瑞。
And so we're still in negotiations.
所以我們仍在談判中。
And so in terms of the economics, I'd say more to come, still to be determined.
所以在經濟學方面,我會說更多,還有待確定。
And if and when we complete that, obviously, I'll be in a better position to answer that.
如果我們完成了,很明顯,我將能夠更好地回答這個問題。
On the $4.5 billion of indirect spend and directionally what do we think we can do there, I don't want to give a specific percentage because we're still working our way through the process.
關於 45 億美元的間接支出以及我們認為我們可以在那裡做些什麼,我不想給出具體的百分比,因為我們仍在努力完成這個過程。
But I think I alluded to this earlier, which is we've already made some nice headway.
但我想我之前提到過這一點,我們已經取得了一些不錯的進展。
I think we can make additional headway.
我認為我們可以取得更多進展。
That additional headway would show up in SI&A.
這種額外的進展將出現在 SI&A 中。
And obviously, our intent would be for that to show up in the IBT as a percentage of revenue line.
顯然,我們的意圖是讓它在 IBT 中顯示為收入線的百分比。
So that's what we're working to do.
這就是我們正在努力做的事情。
Our intent is to improve upon those numbers.
我們的目的是改進這些數字。
And as we work our way through the process and as we have more to report, we'll make sure we do so.
隨著我們在整個過程中的工作以及我們有更多的報告,我們將確保我們這樣做。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Frank.
謝謝你,弗蘭克。
And just a comment on the reasons why we transfer those business to Upjohn.
並且只是對我們將這些業務轉移到 Upjohn 的原因發表評論。
Both of these businesses, first of all, they fit more under Upjohn in terms of the dynamics that they have, so they can be managed much better.
首先,這兩項業務在動態方面更適合 Upjohn,因此可以更好地管理它們。
And secondly, I think they fit very nicely with Mylan because, one, it is the EpiPen predominantly business that Mylan is -- but right now is shared between Mylan, we are providing for them.
其次,我認為它們非常適合 Mylan,因為第一,Mylan 是 EpiPen 的主要業務——但現在由 Mylan 共享,我們正在為他們提供服務。
And the second, it is the -- a partnership that we have with Mylan that was established years back and with generics in Japan.
第二,這是我們與邁蘭多年前建立的合作夥伴關係,並與日本的仿製藥公司建立了合作夥伴關係。
So both of them fit much better in Viatris.
所以他們倆都更適合 Viatris。
And that's the reason why we separate it.
這就是我們將其分開的原因。
And also that will allow you to have, in case that this happens, a much more cleaner view of the growth trajectory of the company because now you know exactly what would be the P&L of the remaining company.
如果發生這種情況,這也將使您能夠更清晰地了解公司的增長軌跡,因為現在您確切地知道剩餘公司的損益。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Great.
偉大的。
Thank you.
謝謝你。
Operator
Operator
Your next question comes from Louise Chen from Cantor.
您的下一個問題來自 Cantor 的 Louise Chen。
Louise Alesandra Chen - Senior Research Analyst & MD
Louise Alesandra Chen - Senior Research Analyst & MD
So I had a few.
所以我有幾個。
My first question is, is the 6% -- approximately 6% 5-year sales CAGR for stand-alone Pfizer or the new Pfizer still hold?
我的第一個問題是,獨立的輝瑞公司或新的輝瑞公司 6%——大約 6% 的 5 年銷售複合年增長率是否仍然存在?
Second question I had is, how much of a priority is M&A for you under the new Pfizer?
我遇到的第二個問題是,在新輝瑞公司的領導下,併購對您來說有多重要?
And what kind of size of deals or types of deals are you most interested in?
您最感興趣的交易規模或交易類型是什麼?
And last question I have is on the PCV data set that's coming through.
最後一個問題是關於即將通過的 PCV 數據集。
You and a competitor also have a whole set of PCV data.
您和競爭對手也擁有一整套 PCV 數據。
I'm just curious how you see that landscape evolving over time.
我只是好奇你如何看待隨著時間的推移而演變的景觀。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes.
是的。
Thank you very, very much, Louise.
非常非常感謝你,路易絲。
Let me start with the 6% CAGR if it still holds.
如果它仍然成立,讓我從 6% 的複合年增長率開始。
Absolutely, it still holds.
當然,它仍然成立。
Actually, as you can see, if anything else, this business that we are projecting 5 years -- all the way to '25, actually, CAGR of 6%.
實際上,正如你所看到的,如果有其他的話,我們預計這項業務將持續 5 年——一直到 25 年,實際上,複合年增長率為 6%。
This year performed at 8%, 9% for the quarter, and we are projecting 8% for 2020.
今年的表現為 8%,本季度為 9%,我們預計 2020 年為 8%。
So definitely, we are on good, let's say, way to achieve that.
因此,可以肯定地說,我們正在努力實現這一目標。
As regards the M&A, yes, the M&A is a very important part of our strategy.
關於併購,是的,併購是我們戰略中非常重要的一部分。
And as I just alluded before, this is why also we are not diluting our firepower with stock purchases right now because we do believe that we can create significant value with the right strategic move.
正如我之前提到的,這就是為什麼我們現在不通過股票購買來稀釋我們的火力,因為我們確實相信我們可以通過正確的戰略舉措創造重大價值。
Now we never say never to anything.
現在我們從不對任何事情說永遠。
But strategically, we have made very clear that we are not interested in a big M&A, that we'll have cost synergies as value driver because, first of all, that will be light and diluted in our top line growth.
但從戰略上講,我們已經非常明確地表示,我們對大型併購不感興趣,我們將成本協同效應作為價值驅動因素,因為首先,這將在我們的收入增長中被稀釋和稀釋。
I don't think there are many companies that they can have this type of growth trajectory, what we have in the next few years.
我不認為有很多公司可以擁有這種類型的增長軌跡,就像我們在未來幾年所擁有的那樣。
Second, it could be destructive because having a big M&A means that thousands of people will have to work on integrations rather than supporting all these products that we just saw that they're growing 20s and 30s and also all this pipeline that is coming up.
其次,它可能具有破壞性,因為進行大規模併購意味著成千上萬的人將不得不致力於集成,而不是支持我們剛剛看到的所有這些產品,這些產品正在增長 20 多歲和 30 多歲,以及所有這些即將到來的管道。
So this -- we never say never, but this is not our strategy.
所以這 - 我們從不說永遠,但這不是我們的策略。
Our strategy for M&A, it is to be able to have Phase 2, Phase 3 programs ready, Phase 2, Phase 3, which could become potential medicines in the period '25, '26, '27, '28 so that we can augment our internal pipeline and be able that we maintain the 6% growth for the long term, actually for the very, very long term because it's right now 5 years, I would say, it's a long term.
我們的併購策略是能夠準備好第 2 階段、第 3 階段的項目,第 2 階段、第 3 階段,這可能成為 '25、'26、'27、'28 期間的潛在藥物,這樣我們就可以增加我們的內部管道,並且能夠長期保持 6% 的增長,實際上是非常非常長期的,因為現在是 5 年,我會說,這是一個長期的。
And the other thing that I want to emphasize, it is that the 6% CAGR, it is risk adjusted.
我想強調的另一件事是 6% 的複合年增長率,這是經過風險調整的。
I repeat, it is risk adjusted.
我再說一遍,這是經過風險調整的。
That means that in our projections, we are adjusting all the non-read studies right now appropriately.
這意味著在我們的預測中,我們現在正在適當地調整所有未閱讀的研究。
Now if all the Phase 3 goes in the right way and they are all successful, it's not going to be 6%.
現在,如果所有第 3 階段都以正確的方式進行並且它們都成功了,那麼它不會是 6%。
It's going to be double-digit, whether it's 12%, 13%, 14%, 15%.
這將是兩位數,無論是 12%、13%、14%、15%。
Now if everything fails, also would not be 6%, will be very low.
現在如果一切都失敗了,也不會是6%,會很低。
But if statistics works and the studies, let's say, 50% more or less are successful, that means that we will achieve 6%.
但是,如果統計數據有效,並且比方說,或多或少 50% 的研究是成功的,這意味著我們將達到 6%。
That's why I want to emphasize that there is no binary event in our projections.
這就是為什麼我要強調我們的預測中沒有二元事件。
Binary event would be if 6% was dependent on 2 or 3 major readouts.
如果 6% 取決於 2 或 3 個主要讀數,則二進制事件將是。
But if they could go one way or another, it could affect.
但是,如果他們可以採取某種方式,它可能會產生影響。
Right now, they are dependent on 15, 16, 17 blockbusters, and then many others but they are much smaller.
目前,它們依賴於 15、16、17 部大片,然後是其他許多大片,但它們的規模要小得多。
So then, Frank, maybe something to add on that before I ask Mikael to comment on PCV data.
那麼,弗蘭克,在我請 Mikael 對 PCV 數據發表評論之前,也許要補充一點。
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Yes.
是的。
And Louise, the only thing I wanted to add, just to punctuate everything Albert said is, and why are we focusing on Phase 2b, Phase 3, it's because the LOEs really start to kick in, in 2027.
路易絲,我唯一想補充的是,為了強調 Albert 所說的一切,我們為什麼要關注第 2b 階段、第 3 階段,因為 LOE 真正開始在 2027 年開始發揮作用。
So if you think about we're in January of 2020, we literally have 8 years to work our way through this problem.
所以如果你想想我們是在 2020 年 1 月,我們實際上有 8 年的時間來解決這個問題。
And by the way, given that kind of a time frame, given the breadth and strength of our pipeline, given our balance sheet, our capacity, obviously, we feel confident we will be able to solve it.
順便說一句,考慮到這樣的時間框架,考慮到我們管道的廣度和實力,考慮到我們的資產負債表,我們的能力,顯然,我們有信心能夠解決它。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Mikael?
邁凱爾?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes.
是的。
I'm pleased that you asked about our pneumo next generation.
我很高興你問到我們的 pneumo 下一代。
So as you know, we have adult and pediatric studies ongoing.
如您所知,我們正在進行成人和兒科研究。
The adult study has been given Breakthrough designation 28th in September based on our encouraging Phase 2 data.
根據我們令人鼓舞的第 2 階段數據,該成人研究已於 9 月 28 日獲得突破性稱號。
And we expect very soon to report Phase 3 outcome of the adult PCV20 trial.
我們預計很快將報告成人 PCV20 試驗的第 3 階段結果。
And obviously, we are optimistic about that outcome based on the Phase 2 and the Breakthrough designation.
顯然,我們對基於第 2 階段和突破性指定的結果持樂觀態度。
On the pediatric, we have now accumulated further post-fourth dose data of the PCV20 Phase 2 study.
在兒科方面,我們現在已經積累了 PCV20 2 期研究的第四次劑量後數據。
This data from the fourth dose further substantiate the positive data reported in the press release after the third dose.
第四劑的這一數據進一步證實了第三劑後新聞稿中報告的陽性數據。
And we expect initiation of Phase 3 soon for the infant vaccine pending discussions with regulators.
我們預計嬰兒疫苗的第 3 階段將很快啟動,等待與監管機構的討論。
The full data set will be presented at a major vaccine-related conference likely mid of this year.
完整的數據集將在今年年中召開的疫苗相關會議上公佈。
Now Albert commented also in his introduction very nicely on the improved relative coverage of the PCV20 from us versus a potential competitor 15-valent, and he mentioned 33% better coverage for adults and 42% better coverage in the U.S. for infants.
現在,Albert 在他的介紹中也很好地評論了我們的 PCV20 相對於潛在競爭對手 15 價的相對覆蓋率有所提高,他提到在美國,成人的覆蓋率提高了 33%,嬰兒的覆蓋率提高了 42%。
Obviously, very important, significant, better coverage.
顯然,非常重要、意義重大、覆蓋面更好。
I just wanted to punctuate when you look in the top European market, similar, the improved coverage in adults is actually 60% to 100%; in infants, 80% to 200%.
當您查看歐洲頂級市場時,我只想強調一下,類似地,成年人的覆蓋率實際上提高了 60% 到 100%;在嬰兒中,80% 到 200%。
This is all for invasive pneumococcal disease.
這都是針對侵襲性肺炎球菌疾病的。
Also in U.S., we have analyzed for community-acquired pneumonia where we see substantial better coverage for the 20- versus a potential 15-valent.
同樣在美國,我們對社區獲得性肺炎進行了分析,我們發現 20 價的覆蓋率大大高於潛在的 15 價。
So all in all, you can see, we look forward to data sets advancing the program and think it would be the premier 20-valent and premier pneumococcal vaccine for patients.
所以總而言之,你可以看到,我們期待數據集推進該計劃,並認為這將是用於患者的首屈一指的 20 價和首屈一指的肺炎球菌疫苗。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Thank you.
謝謝你。
Operator
Operator
Your next question comes from Steve Scala from Cowen.
您的下一個問題來自 Cowen 的 Steve Scala。
Stephen Michael Scala - MD & Senior Research Analyst
Stephen Michael Scala - MD & Senior Research Analyst
I have a few questions.
我有幾個問題。
An increase in the dividend was mentioned twice, but it sounds as though Upjohn will be spun, not split, in which case the dividend will be reduced.
兩次提到股息的增加,但聽起來 Upjohn 將被旋轉,而不是拆分,在這種情況下,股息將減少。
So I'm wondering if you could clarify the dividend comment.
所以我想知道你是否可以澄清股息評論。
And I assume the 2020 EPS guidance implies a spin, not a split.
而且我認為 2020 年 EPS 指導意味著旋轉,而不是分裂。
Secondly, on the abrocitinib versus Dupixent study, given the fact that it is completed, Mikael, I'm wondering if the data met the very positive portrayal you provided on the Q3 call, which included superior itch relief to Dupixent.
其次,關於 abrocitinib 與 Dupixent 的研究,鑑於它已經完成,Mikael,我想知道數據是否符合你在第三季度電話會議上提供的非常積極的描述,其中包括比 Dupixent 更好的止癢效果。
And then lastly, will the proof-of-concept DMD data be presented at the March 31 meeting?
最後,概念驗證 DMD 數據是否會在 3 月 31 日的會議上公佈?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
No, thank you very much, Steve.
不,非常感謝你,史蒂夫。
Very good questions.
非常好的問題。
So Frank, why don't you clarify once more the dividend?
所以弗蘭克,你為什麼不再次澄清股息?
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Sure.
當然。
So Steve, in terms of the guidance, you're right.
所以史蒂夫,就指導而言,你是對的。
It assumes a spin, not a split.
它假定旋轉,而不是分裂。
And then in terms of the dividend, you said -- I think you said in your question it'd be a reduction.
然後就股息而言,你說 - 我想你在你的問題中說這將是減少。
I don't see it that way.
我不這麼看。
What we've said is the sum of Viatris dividend and our dividend would equal the current dividend that a Pfizer shareholder receives today.
我們所說的是 Viatris 股息的總和,我們的股息將等于輝瑞股東今天收到的當前股息。
So I don't see a reduction in the dividend.
所以我認為股息不會減少。
The dividend income will be kept whole.
股息收入將保持不變。
And I think we've been very clear about that all along.
我認為我們一直都很清楚這一點。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
And we'll continue growing, maybe not at the same pace of -- which we do right now, $0.02 per quarter, but we'll continue growing.
我們將繼續增長,也許不會以我們現在所做的速度相同,每季度 0.02 美元,但我們將繼續增長。
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Right.
正確的。
And Steve, I can quickly run the numbers for you if you'd like.
史蒂夫,如果你願意,我可以快速為你計算數字。
Just -- so if you think what Viatris has said is their first full year of about $4 billion of free cash flow, they pay about 25% of that in the dividend, so that's $1 billion.
只是 - 所以如果你認為 Viatris 所說的是他們第一個全年大約 40 億美元的自由現金流,他們支付了大約 25% 的股息,所以這是 10 億美元。
Total Viatris will have about 1.2 billion shares.
Total Viatris 將擁有約 12 億股股票。
You put the $1 billion over 1.2 billion shares, it's about $0.83.
你把 10 億美元放在 12 億股股票上,大約是 0.83 美元。
The exchange ratio is about .12.
兌換比率約為 0.12。
You put 100 shares of Pfizer, you get 12 shares of Viatris.
你投入 100 股輝瑞,你得到 12 股 Viatris。
Assuming a spin, that's roughly $10 a share.
假設旋轉,這大約是每股 10 美元。
We would reduce our dividend on an annual basis by that $10.
我們將每年減少 10 美元的股息。
But the sum of our dividend plus that $10...
但是我們的股息加上那10美元的總和......
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
$0.10.
0.10 美元。
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
$0.10, I'm sorry, thank you, would equal the -- what a Pfizer shareholder gets today.
0.10 美元,對不起,謝謝,相當于輝瑞股東今天得到的。
And in my thing, it's $10.
在我看來,它是 10 美元。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes.
是的。
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
$10, not $0.10.
10 美元,而不是 0.10 美元。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Okay.
好的。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Abrocitinib?
阿布替尼?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes.
是的。
So thank you for your interest in abrocitinib, and we believe that it's going to be a new drug class for such a prevalent disease that affects tens of millions of Americans, atopic dermatitis and where an oral alternative seems to be a real patient and physician preference.
因此,感謝您對 abrocitinib 的興趣,我們相信它將成為一種新的藥物類別,用於治療這種影響數千萬美國人的流行疾病、特應性皮炎以及口服替代品似乎是真正的患者和醫生偏好.
We will soon report out the data from the important Compare study.
我們將很快報告來自重要比較研究的數據。
So I haven't actually seen the data, so I can only punctuate a little bit what we discussed at earlier investor meetings, that the historical comparison between abrocitinib and Dupixent suggests that we should expect to see similar or better impact on clearing skin.
所以我實際上還沒有看到數據,所以我只能強調我們在早期投資者會議上討論的內容,即 abrocitinib 和 Dupixent 之間的歷史比較表明我們應該期望看到對清潔皮膚產生相似或更好的影響。
And particularly, as Albert alluded to in his introduction, there is an important key secondary end point looking at itch relief starting with a readout already of 2 weeks and then following the study through the 12 to 16 weeks.
特別是,正如 Albert 在他的介紹中提到的那樣,有一個重要的關鍵次要終點是觀察瘙癢緩解,從 2 週的讀數開始,然後在 12 至 16 週內進行研究。
And historical data suggests that we should be very optimistic about abrocitinib outperforming biological such as Dupixent on itch relief at earlier time points and provide a potential benefit of early onset of relief for disease.
歷史數據表明,我們應該非常樂觀地認為 abrocitinib 在早期緩解瘙癢方面優於 Dupixent 等生物製劑,並提供早期緩解疾病的潛在益處。
Now we have to wait for the data to be able to obviously be absolutely confident in that outcome.
現在我們必須等待數據能夠明顯地對該結果充滿信心。
But this is what I believe and look forward very much to see the data come shortly.
但這是我相信並非常期待看到數據很快到來的原因。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
And on the DMD question?
關於 DMD 問題?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes.
是的。
We are finalizing, I think, the program for the R&D day.
我認為,我們正在敲定研發日的計劃。
So I can't be absolutely promise you, but I think it's likely that such an interesting program as the DMD gene therapy will be one of the potential agenda items.
所以我不能絕對向你保證,但我認為像 DMD 基因治療這樣有趣的項目很可能會成為潛在的議程項目之一。
And obviously, we would like to then share updates from increased number of patients over a longer time period.
顯然,我們希望在更長的時間內分享來自更多患者的更新。
So please welcome and take a front-row seat.
所以請歡迎並坐在前排座位上。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much to both of them.
非常感謝他們倆。
By the way, Frank, as always, was right.
順便說一句,弗蘭克一如既往地是對的。
It's $10 for 12 shares for Mylan.
邁蘭 12 股 10 美元。
So...
所以...
Operator
Operator
Your next question comes from Geoff Meacham from Bank of America.
您的下一個問題來自美國銀行的 Geoff Meacham。
Geoffrey Christopher Meacham - Research Analyst
Geoffrey Christopher Meacham - Research Analyst
Just have a couple.
就來一對吧。
Mikael, on the gene therapy platform with the advancement of hemophilia A and B as well as DMD into Phase 3, what's the capacity to add additional indications to the portfolio?
Mikael,在血友病 A 和 B 以及 DMD 進入第三階段的基因治療平台上,有什麼能力為產品組合增加額外的適應症?
I mean you guys have been successful with partnering, but at this point, it does seem like you could expand the platform organically in a material way.
我的意思是你們在合作方面取得了成功,但在這一點上,你們似乎可以通過物質方式有機地擴展平台。
And then for Angela on Xtandi, I just wanted to get your perspective on the inroads you've made in M0 prostate patients.
然後對於 Xtandi 上的 Angela,我只是想了解您對 M0 前列腺患者所取得的進展的看法。
And what do you think could represent a tipping point commercially, especially given generic ZYTIGA available in the U.S.?
您認為什麼可以代表商業上的轉折點,特別是考慮到在美國可以買到的仿製藥 ZYTIGA?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Mikael?
邁凱爾?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes.
是的。
So Geoff, we share your enthusiasm for the gene therapy platform.
Geoff,我們分享您對基因治療平台的熱情。
And what is particularly, I think, strategic advantage for us is the end-to-end capability from discovery, clinical, manufacturing.
我認為,特別是我們的戰略優勢是發現、臨床和製造的端到端能力。
And of course, that capability is also linked to important external partners that gives us capacity to advance increasing number of internal as well as partner programs.
當然,這種能力也與重要的外部合作夥伴有關,這使我們有能力推進越來越多的內部和合作夥伴計劃。
And we have earned option for the Vivet Wilson disease program that could, in a relatively near-term future, be available for clinical studies.
我們已經獲得了 Vivet Wilson 病項目的選擇權,該項目可以在相對近期的將來用於臨床研究。
And we expect from internal and external initiatives to aspire to about bringing one new gene therapy into the clinic every year or so for the next period to come.
我們期望內部和外部倡議能夠在接下來的一段時間內每年左右將一種新的基因療法引入臨床。
And we think that should build up a very comprehensive gene therapy portfolio.
我們認為這應該建立一個非常全面的基因治療產品組合。
The 3 programs you alluded to are, of course, the frontier for us with factor IX that we hope to be the first company bringing that over the finish line in Phase 3 now and to start additional 2 Phase 3s for HemA where we think we have a best-in-class profile so far.
當然,你提到的 3 個項目是我們在第 IX 階段的前沿,我們希望成為第一家在第 3 階段完成該項目的公司,並為 HemA 啟動額外的 2 個第 3 階段,我們認為我們有迄今為止一流的個人資料。
And then we already spoke about DMD.
然後我們已經談到了 DMD。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much.
非常感謝。
Angela?
安吉拉?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Sure.
當然。
So in terms of the M0, the non-metastatic CRPC, I mean, what we're seeing here is just tremendous growth and tremendous performance.
所以就 M0 而言,非轉移性 CRPC,我的意思是,我們在這裡看到的只是巨大的增長和巨大的性能。
Just broadly speaking, in terms of Xtandi, we had a great quarter, right?
從廣義上講,就 Xtandi 而言,我們有一個很棒的季度,對吧?
We grew 29%, and this was driven by 2 things.
我們增長了 29%,這是由兩件事驅動的。
One was actually a demand across both metastatic as well as non-metastatic, but also what we saw was the continued expansion of the actual class, the novel hormone therapies.
一個實際上是對轉移性和非轉移性的需求,而且我們看到的是實際類別的持續擴展,即新型激素療法。
And in this class, Xtandi has the lion's share.
在這個班級中,Xtandi 佔據了最大的份額。
We have about 35% share right now.
我們現在擁有大約 35% 的份額。
So first of all, to answer your question vis-à-vis generic ZYTIGA, we really don't see a competition from a generic versus brand in this instance.
因此,首先,要回答您針對通用 ZYTIGA 的問題,在這種情況下,我們真的沒有看到通用與品牌之間的競爭。
I think the competition with ZYTIGA is really amongst generic ZYTIGA versus branded ZYTIGA, whereas what we're seeing here is a clear uptick in Xtandi.
我認為與 ZYTIGA 的競爭實際上是通用 ZYTIGA 與品牌 ZYTIGA 之間的競爭,而我們在這裡看到的是 Xtandi 的明顯上升。
And specifically, from the PROSPER trial in this M0 population, as you say, we are continuing to see, as I've talked about in all the previous quarters, really, really significant and very constant uptake in urology prescribing.
具體來說,正如你所說,從這個 M0 人群的 PROSPER 試驗中,我們繼續看到,正如我在前幾個季度所談到的那樣,泌尿科處方確實非常重要且非常持續。
And we do believe that this is underpinning the growth of our non-metastatic population.
我們確實相信,這正在支撐我們非轉移性人口的增長。
And the fact that these are patients also earlier in their disease is helpful in driving our growth in this population.
事實上,這些患者也處於疾病早期,這有助於推動我們在這一人群中的增長。
I'll also mention that just from a market share perspective, though the non-metastatic, the M0 population, has Xtandi, ERLEADA as well as NUBEQA, Xtandi, by far and away, has the leading market share in this segment and has been from the time that it was launched.
我還要提一下,僅從市場份額的角度來看,雖然非轉移性 M0 人群有 Xtandi、ERLEADA 以及 NUBEQA,但 Xtandi 在這一領域的市場份額遙遙領先,並且一直從推出之日起。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Great.
偉大的。
Thank you, Angela.
謝謝你,安吉拉。
Operator
Operator
Our next question comes from Tim Anderson from Wolfe Research.
我們的下一個問題來自 Wolfe Research 的 Tim Anderson。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
A couple of questions.
幾個問題。
One is on Prevnar in China.
一個是在中國的 Prevnar。
So sales have been ramping up there, but the regulatory authorities recently approved a domestically produced 13-valent product.
所以那裡的銷售一直在增加,但監管機構最近批准了一種國產的 13 價產品。
And the CEO of that company suggests they have capacity that's in the tens of millions of doses, and who knows if that's true or not.
那家公司的首席執行官暗示他們有數千萬劑的能力,誰知道這是否屬實。
But I'm wondering if you can give some perspective on how you see competitive dynamics in a situation like this going forward, not only in China where a domestic producer could potentially benefit from favoritism but also if that company were to take their product into other markets outside of China at a different price point.
但我想知道您是否可以就您如何看待未來這種情況下的競爭動態發表一些看法,不僅在中國國內生產商可能會從偏袒中受益,而且如果該公司將其產品帶入其他中國以外的市場價格不同。
I think a lot of investors assume vaccines are durable forever, but I'm wondering if this sort of thing could be disruptive and how you take the sort of potential competition into your forecast.
我認為很多投資者認為疫苗是永遠耐用的,但我想知道這種事情是否會造成破壞,以及你如何將這種潛在的競爭納入你的預測。
Second question is on M&A.
第二個問題是關於併購的。
So any M&A that you may engage with in 2020, should we assume at least during this first 6-month window while you still have Upjohn, that, that is probably put on hold?
因此,您在 2020 年可能進行的任何併購,我們是否應該至少在前 6 個月的窗口期間假設您仍然擁有 Upjohn,那可能會被擱置?
And then last question on VYNDAQEL.
然後是關於 VYNDAQEL 的最後一個問題。
Might there be a low-hanging fruit phenomenon where we see initial nice uptake but then it kind of flattens out suddenly?
可能會出現一種低垂的果實現象,我們看到最初的吸收很好,但後來突然變平了?
Or do you expect this will be continued strong linear growth?
還是您預計這將是持續強勁的線性增長?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much.
非常感謝。
I will give a quick answer to your M&A question, Tim, and then Angela can deal with Prevnar in China and Vyndaqel.
我會快速回答你的併購問題,蒂姆,然後安吉拉可以與 Prevnar 在中國和 Vyndaqel 打交道。
On M&A, no, the answer is no, absolutely not.
在併購方面,不,答案是否定的,絕對不是。
We are very active looking on -- to invest capital on value creation opportunities.
我們非常積極地尋找——將資本投資於創造價值的機會。
And then I assume that we will have several of them in the first half of 2020 before the close of the deal.
然後我假設在交易結束之前,我們將在 2020 年上半年擁有其中的幾個。
Again, across the lines that I have described, you know exactly what we are doing.
同樣,在我所描述的範圍內,您確切地知道我們在做什麼。
We want to make sure that we sustain the growth beyond 2027 when the LOEs will have some impact.
我們希望確保在 2027 年之後保持增長,屆時 LOE 將產生一些影響。
Angela, what about Prevnar in China?
Angela,Prevnar 在中國怎麼樣?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Sure.
當然。
So we acknowledge that there is a new competitor in the form of Walvax in PCV13.
因此,我們承認在 PCV13 中有一個新的競爭對手,即 Walvax。
However, I want to recognize that there are some differences here.
但是,我想承認這裡存在一些差異。
Though it is a 13-valent vaccine, Walvax's vaccine is made with a different conjugate, and this conjugate technology being an older technology so quite different from what we see in PCV13.
雖然它是一種 13 價疫苗,但 Walvax 的疫苗是用不同的偶聯物製成的,而且這種偶聯技術是一種較老的技術,與我們在 PCV13 中看到的完全不同。
That being said, it is a competitor.
話雖如此,它是一個競爭對手。
However, if you sort of step back and look at the opportunity that we have in pneumococcal vaccinations, there are approximately 14 million new births every year in China.
然而,如果你退後一步,看看我們在肺炎球菌疫苗接種方面的機會,中國每年大約有 1400 萬新生兒。
And today, only over maybe 1% of those infants are being vaccinated.
而今天,只有超過 1% 的嬰兒接種了疫苗。
So regardless of the volumes that Walvax might have available, I think the opportunity between us is just much larger than that.
因此,無論 Walvax 可能擁有多少數量,我認為我們之間的機會遠不止於此。
And we have a tremendous amount of untapped potential in the marketplace.
而且我們在市場上有大量未開發的潛力。
And we are confident that with the quality, the reliability as well as the tremendous experience that Pfizer has had globally with PCV13 but also the tremendous success that we've had in China specifically for PCV13, that our growth will continue and this is what we expect.
我們相信,憑藉輝瑞在全球範圍內使用 PCV13 獲得的質量、可靠性和豐富經驗,以及我們在中國特別針對 PCV13 取得的巨大成功,我們的增長將繼續下去,這就是我們的目標預計。
We have a very robust footprint.
我們擁有非常強大的足跡。
As you know, the vaccines, and it will be the same for Walvax's PCV13, this is an out-of-pocket market and it will be the same for the both of us.
如你所知,疫苗和 Walvax 的 PCV13 一樣,這是一個自費市場,對我們雙方來說都是一樣的。
So this is where we'll be competing, which is why having a robust promotional engine and having a footprint of representatives that can really be available to support patients and caregivers at the points of vaccinations is really important.
所以這就是我們將要競爭的地方,這就是為什麼擁有一個強大的促銷引擎並擁有一個真正可以在疫苗接種點為患者和護理人員提供支持的代表是非常重要的。
And I think in this regard, we have demonstrated great expertise and ability to grow this market.
我認為在這方面,我們已經展示了發展這個市場的強大專業知識和能力。
So that's how we see it.
這就是我們的看法。
We acknowledge the competition, but we continue to see tremendous potential.
我們承認競爭,但我們繼續看到巨大的潛力。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
What about VYNDAQEL?
VYNDAQEL 怎麼樣?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
All right.
好的。
So in terms of VYNDAQEL, so yes, of course, in the year of launch, one might expect to see a little bit of a bolus, a number of patients who have been identified and are awaiting diagnosis and treatment.
所以就 VYNDAQEL 而言,所以是的,當然,在推出的那一年,人們可能會期待看到一點點推注,一些已被確定並正在等待診斷和治療的患者。
That being said, we are confident of -- what we're confident about, what we've learned in the marketplace in our first year of launch, we are confident that we have the right set of tools for helping to -- physicians to suspect the patients that might have ATTR-CM.
話雖如此,我們有信心 - 我們有信心,我們在推出的第一年在市場上學到了什麼,我們有信心我們有一套正確的工具來幫助 - 醫生懷疑可能患有 ATTR-CM 的患者。
We have mobilized education around using noninvasive methods like scintigraphy to diagnose patients, and we've also mobilized a patient support hub to help patients receive their medications.
我們圍繞使用閃爍掃描等非侵入性方法來診斷患者開展了教育,我們還動員了患者支持中心來幫助患者接受藥物治療。
So I think doing more of that as well as continuing to think about new methods to help diagnose and treat patients such as using artificial intelligence and increased number of tools, all of that will continue to support our ability to drive the important and rapid diagnosis of patients as well as their treatment.
所以我認為做更多的事情以及繼續思考幫助診斷和治療患者的新方法,例如使用人工智能和增加工具數量,所有這些都將繼續支持我們推動重要和快速診斷的能力患者以及他們的治療。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Right.
正確的。
Thank you.
謝謝你。
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 Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
A couple of questions, please.
有幾個問題,請。
Firstly, on your pending oncology biosimilars rollout in the U.S. Given the challenges historically with biosimilar penetration, could you talk to your expectations, particularly with these 2 drugs?
首先,關於您在美國即將推出的腫瘤生物仿製藥。鑑於歷史上生物仿製藥滲透的挑戰,您能否談談您的期望,尤其是對這兩種藥物的期望?
There should be an economic incentive for payers given the pass-through, but yet, there's issues in patients already on an established innovative biosimilar to switch -- and it's a brand to switch to biosimilar.
考慮到傳遞,應該對付款人有經濟激勵,但是,已經在已建立的創新生物仿製藥轉換的患者存在問題——這是一個轉向生物仿製藥的品牌。
So if you could give us some kind of sense as how much penetration, how quickly you may expect, that would be super helpful.
所以,如果你能給我們某種感覺,比如你可以期待多少滲透,多快,那將是非常有幫助的。
And then second, in terms of tafamidis, Angela, you kind of gave some penetration figures at the beginning, which I was struggling to keep up with and write down.
其次,就 tafamidis 而言,安吉拉,你在一開始就給出了一些滲透率數據,我一直在努力跟上並寫下來。
But just more broadly, could you outline how large you think the untapped patient population really is here and how far Pfizer is along in establishing that market?
但更廣泛地說,您能否概述一下您認為未開發的患者群體到底有多大,以及輝瑞在建立該市場方面走了多遠?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Angela, a lot of questions for you today.
安吉拉,今天有很多問題要問你。
Please go ahead.
請繼續。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Okay.
好的。
Sure.
當然。
All right.
好的。
So I think, firstly, we see the dynamics in oncology biosimilars being very different from that of the -- what we saw in -- for inflammation in the form of Inflectra.
所以我認為,首先,我們看到腫瘤生物仿製藥的動態與我們所看到的 Inflectra 形式的炎症非常不同。
So to your point about how will the dynamics change here and how quickly can payers as well as providers capture their savings, it's going to be much quicker.
因此,就您的觀點而言,這裡的動態將如何變化以及付款人和提供者可以多快獲得他們的儲蓄,這將會快得多。
This is -- the use of oncology biosimilars are much more rapid, right?
這是——腫瘤生物類似藥的使用要快得多,對吧?
You see more patients cycling through, treatment times are much shorter.
您會看到更多的患者騎自行車,治療時間要短得多。
So that's going to enable payers and providers to capture savings much more quickly, which is a very different dynamic than you see in Inflectra where it's a chronic treatment and patients are on their treatment for a very long time.
因此,這將使支付者和提供者能夠更快地獲得節省,這與您在 Inflectra 中看到的非常不同的動態,因為它是一種慢性治療,並且患者接受了很長時間的治療。
So I think that's one big difference.
所以我認為這是一個很大的區別。
The second is that there is already a -- some -- we already have some precedents.
第二個是已經有——一些——我們已經有一些先例。
We saw this with RETACRIT where after a year of being in the market, though I know it's a supportive care in oncology, we already have 20% market share.
我們在 RETACRIT 看到了這一點,在進入市場一年後,雖然我知道這是腫瘤學的支持性護理,但我們已經擁有 20% 的市場份額。
This is still far cry from what we see in Europe where there's much more rapid uptake that I think that it's a signal and an indicator of the differences you see in the various biosimilar markets.
這與我們在歐洲看到的情況相去甚遠,歐洲的吸收速度要快得多,我認為這是一個信號,也是您在各種生物仿製藥市場中看到的差異的指標。
And we also have some early signals from competitor biosimilars that have already some good market share in this -- in oncology biosimilars.
我們還從競爭對手的生物仿製藥中獲得了一些早期信號,這些生物仿製藥已經在這方面擁有良好的市場份額——在腫瘤生物仿製藥領域。
So I think that we have some good indicators that this is going to be different.
所以我認為我們有一些很好的指標表明這將有所不同。
I think the benefit that we see here is that we have a portfolio of 3 oncology biosimilars all coming out around the similar time, like around now.
我認為我們在這裡看到的好處是,我們擁有 3 種腫瘤生物仿製藥的產品組合,它們都在同一時間推出,就像現在一樣。
And I think a -- what -- -- we have a robust pricing strategy, a discount to the WACC of the originator as well as, I think, strong relationships and networks built with both providers and payers that give us confidence that this will be an area of high growth for Pfizer.
而且我認為 - 什麼 - - 我們有一個強大的定價策略,對發起人的 WACC 有折扣,而且我認為,與供應商和付款人建立的牢固關係和網絡讓我們相信這將成為輝瑞高速增長的領域。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Angela.
謝謝你,安吉拉。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
And then your question was around tafamidis.
然後你的問題是關於 tafamidis。
Sorry, can you just repeat that again?
對不起,你能再重複一遍嗎?
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
It was the untapped population.
這是未開發的人口。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
The untapped population.
未開發的人口。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
So as we have said in previous calls, we do believe that this is a rare disease and that in the U.S., there will be about 100,000 patients in total.
因此,正如我們在之前的電話會議中所說,我們確實相信這是一種罕見的疾病,在美國,總共將有大約 100,000 名患者。
Globally, 500,000, but in the U.S., 100,000.
在全球範圍內,500,000,但在美國,100,000。
To date, we have diagnosed 9,000 patients, so that leads us to 9% of the population that we have diagnosed.
迄今為止,我們已診斷出 9,000 名患者,這使我們達到了已診斷人群的 9%。
So while this may feel like very significant progress from the time that we have launched, and it is, I think you can also see that we have a long, long way to go to finding all 100,000 of these patients.
因此,雖然從我們推出以來這可能感覺是非常重大的進步,而且確實如此,但我認為您也可以看到,要找到所有 100,000 名患者,我們還有很長的路要走。
And what I spoke earlier about in terms of the education, in terms of how you suspect the disease, how you diagnose the disease and then very quickly gaining access to our patients and benefit from treatment of the disease, these are all 3 levers that we are intensely focused on.
而我之前談到的教育方面,關於你如何懷疑疾病,你如何診斷疾病,然後很快接觸到我們的患者並從疾病治療中受益,這些都是我們的三個槓桿被高度關注。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Right.
正確的。
Thank you.
謝謝你。
Operator
Operator
Your next question comes from Navin Jacob from UBS.
您的下一個問題來自瑞銀的 Navin Jacob。
Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic
Navin Cyriac Jacob - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic
A couple, if I may.
如果可以的話,一對夫婦。
Just on biosimilars following up with Angela, your comment about strong growth continuing on for the biosimilars.
就生物仿製藥跟進安吉拉而言,您對生物仿製藥繼續強勁增長的評論。
So wondering if you could give any color around how we should think about the trajectory over the next couple of years.
所以想知道你是否可以就我們應該如何思考未來幾年的軌跡給出任何顏色。
Is this a doubling or tripling of that now almost $1 billion business?
這是現在近 10 億美元業務的兩倍還是三倍?
And then also, would love to understand how you're thinking about the tail of each of the individual assets.
然後,很想了解您如何考慮每個單獨資產的尾部。
Are you seeing -- should we be thinking of this as a ramp that goes up for a few years and then eventually starts tailing off like other generics?
您是否看到 - 我們是否應該將其視為一個上升幾年的斜坡,然後最終像其他仿製藥一樣開始逐漸減少?
Or do you see this stabilizing and having a sustainable tail?
還是您看到這種穩定並具有可持續發展的尾巴?
And then just on VYNDAQEL, you received positive CHMP opinion in the EU in December.
然後就在 VYNDAQEL 上,您在 12 月在歐盟收到了積極的 CHMP 意見。
Given that VYNDAQEL's already approved in the polyneuropathy indication, wondering how we should be thinking about the price with the addition of the cardiomyopathy indication.
鑑於 VYNDAQEL 已經在多發性神經病適應症中獲得批准,想知道我們應該如何考慮加上心肌病適應症的價格。
Is there any chance for moving that around?
有沒有機會移動它?
And then how we think about the ramp in the EU relative to the U.S.
然後我們如何看待歐盟相對於美國的增長。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Sure.
當然。
So maybe I'll start with the last one first.
所以也許我會先從最後一個開始。
So you're right, we just received EU approval for VYNDAQEL.
所以你是對的,我們剛剛獲得了歐盟對 VYNDAQEL 的批准。
And as you know, there's a -- there's quite a time lag between approval and then reimbursement in each of the countries.
如您所知,每個國家/地區的批准和報銷之間存在相當長的時間差。
So all I can say is right now, we are in active negotiations with the countries in terms of determining the price of VYNDAQEL as well as its reimbursement.
所以我現在只能說,我們正在與各國就確定 VYNDAQEL 的價格及其報銷進行積極談判。
You refer to the fact that we already have the 20-milligram approved for polyneuropathy in Europe, and we recognize that.
您提到我們已經在歐洲批准了 20 毫克用於多發性神經病的事實,我們承認這一點。
That being said, we have -- first of all, ATTR-CM is a completely different indication.
話雖如此,我們 - 首先,ATTR-CM 是一個完全不同的指示。
The trials that were conducted as well as the significant mortality benefits that were demonstrated in our clinical trials for ATTR-CM are completely different, and we have the clinical data to demonstrate the great patient benefit that we have in ATTR-CM.
在我們的 ATTR-CM 臨床試驗中進行的試驗以及顯著的死亡率益處是完全不同的,我們有臨床數據來證明我們在 ATTR-CM 中的巨大患者益處。
And so that's the basis of our discussions with each of the countries in Europe for reimbursement.
這就是我們與歐洲每個國家討論報銷問題的基礎。
Your second question was around VYNDAQEL growth and sort of the pace of it.
您的第二個問題是關於 VYNDAQEL 的增長及其速度。
I think the way to think about it is the following: We have, through analogs, seen that only 30% to 50% of all rare diseases are ever diagnosed.
我認為思考它的方式如下:通過類比,我們看到只有 30% 到 50% 的罕見病被診斷出來。
But of course, we believe that based on the mortality data that we have and the patient benefit that can be derived, that it is critical that we meet that or at least beat that.
但是,當然,我們相信,根據我們擁有的死亡率數據和可以得出的患者受益,我們滿足或至少超越這一點至關重要。
And so that's what we're intensely focused on.
這就是我們非常關注的內容。
We have 10% of our patients or 9% in the U.S. that are diagnosed today.
我們今天有 10% 的患者或美國 9% 的患者被確診。
We have a long way to go, and that's what we need to do.
我們還有很長的路要走,這就是我們需要做的。
Your last question...
你最後一個問題...
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations
What's the rhythm on the biosimilars?
生物仿製藥的節奏是什麼?
We've had strong growth, 22% this year for the year.
我們有強勁的增長,今年增長了 22%。
What can we expect going forward?
我們可以期待什麼?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
That's right.
這是正確的。
So I think in terms of the biosimilars, again, this is an area of growth that we can anticipate.
因此,我認為就生物仿製藥而言,這是一個我們可以預期的增長領域。
We have 3 biosimilars now in oncology, plus the 2 that we have in supportive care.
我們現在有 3 種生物仿製藥用於腫瘤學,還有 2 種用於支持治療。
And so we look forward to this being a significant growth contributor to Oncology portfolio, not just from a growth percentage perspective but also from a revenue base perspective.
因此,我們期待這成為腫瘤學產品組合的重要增長貢獻者,不僅從增長百分比的角度來看,而且從收入基礎的角度來看。
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Great.
偉大的。
Yes, I just wanted to add that VYNDAQEL cardiomyopathy has a positive EU recommendation.
是的,我只是想補充一點,VYNDAQEL 心肌病有一個積極的歐盟推薦。
So we expect the approval to come soon, and that links very nicely to really helpful outline you did, Angela.
因此,我們預計很快就會獲得批准,並且這很好地鏈接到您所做的真正有用的大綱,安吉拉。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Thanks, Mikael.
謝謝,米凱爾。
Operator
Operator
Your final question comes from the line of Mani Foroohar from SVB Leerink.
您的最後一個問題來自 SVB Leerink 的 Mani Foroohar。
Mani Foroohar - MD of Genetic Medicines & Senior Research Analyst
Mani Foroohar - MD of Genetic Medicines & Senior Research Analyst
A couple little ones on the rare disease side.
罕見病方面的幾個小孩。
In terms of tafamidis, we saw pretty attractive growth OUS, including some markets that don't necessarily have the cardiomyopathy indication yet.
就 tafamidis 而言,我們看到 OUS 的增長非常有吸引力,包括一些還不一定有心肌病適應症的市場。
Is there some follow-on benefit in polyneuropathy from the increased promotional efforts in cardiomyopathy in Europe and elsewhere?
歐洲和其他地方加大對心肌病的宣傳力度是否會對多發性神經病產生一些後續益處?
As a second question, given the expansion of patient opportunity in the polyneuropathy in the U.S., how do you think about the opportunity to pursue a supplemental NDA or a similar strategy in the U.S. based on the real-world evidence guidelines laid out previously by the FDA?
作為第二個問題,鑑於美國多發性神經病患者機會的增加,您如何看待基於美國先前製定的真實世界證據指南在美國尋求補充 NDA 或類似策略的機會食藥監局?
Or would that require a separate study?
還是需要單獨研究?
And then finally, on the gene therapy side, obviously pretty interesting data, hemophilia at ASH moving forward into a couple of Phase 3s now.
最後,在基因治療方面,顯然是非常有趣的數據,ASH 的血友病現在進入了幾個第 3 階段。
How do you think about that market in a universe where you have multiple therapies within -- in curative intent in gene therapy, alongside a number of fairly robust chronic therapies?
您如何看待在您擁有多種療法的宇宙中的市場 - 在基因療法的治療意圖中,以及一些相當強大的慢性療法?
Who are the patients who should receive an irreversible intervention in terms of gene therapy?
在基因治療方面,哪些患者應該接受不可逆轉的干預?
And who do you think are more appropriate for a chronic therapy such as your own benefits?
你認為誰更適合慢性治療,比如你自己的好處?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes.
是的。
I think I will ask Mikael to start with gene therapy and then ask Angela this great portfolio assets that we have and how they fit together.
我想我會問 Mikael 從基因治療開始,然後問安吉拉我們擁有的這些偉大的投資組合資產以及它們如何組合在一起。
Mikael?
邁凱爾?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes, thank you very much.
是的謝謝你。
What I think is unique in our hemophilia portfolio, first, of course, we have a legacy being one of the pioneers for intravenous delivery of factor VIII and factor IX.
我認為在我們的血友病產品組合中是獨一無二的,首先,當然,我們擁有作為 VIII 因子和 IX 因子靜脈給藥的先驅之一的傳統。
So we have a platform and experience on the business and R&D side.
所以我們在業務和研發方面都有平台和經驗。
And as you so nicely alluded to, we also shared with our partner, Sangamo, some very much best-in-class data recently on the factor VIII gene therapy.
正如您很好地提到的那樣,我們還與我們的合作夥伴 Sangamo 分享了最近關於因子 VIII 基因治療的一些非常好的數據。
Our current portfolio has factor VIII and factor IX gene therapy plus our TFPI antibody that has, like HEMLIBRA, an opportunity to provide a subdued alternative, but actually, TFPI can be applicable for both factor VIII and factor IX deficiency.
我們目前的產品組合包括因子 VIII 和因子 IX 基因療法以及我們的 TFPI 抗體,它與 HEMLIBRA 一樣,有機會提供一種柔和的替代方案,但實際上,TFPI 可適用於因子 VIII 和因子 IX 缺乏症。
So the way we see it develop is that I think physicians will look at gene therapies that have durability and good tolerability.
所以我們看到它發展的方式是,我認為醫生會關注具有持久性和良好耐受性的基因療法。
And that has really been the hallmark for the strategies when we developed factor VIII and factor IX best-in-class profile.
當我們開發因子 VIII 和因子 IX 同類最佳配置文件時,這確實是這些策略的標誌。
Because there are alternatives to these patients, so once they see the data for drugs -- treatments that are approved, that have durability and really good outcomes, which I think has been so far what we have seen with our gene therapies, those will be the one that can be adopted because there are alternatives that have less convenience but will, at least until strong data is available, be used.
因為這些患者有替代品,所以一旦他們看到藥物數據——獲得批准、具有持久性和非常好的結果的治療方法,我認為到目前為止我們在基因療法中所看到的情況,那些將是一種可以採用的方法,因為有一些替代方案不太方便,但至少在有強大數據可用之前會被使用。
For patients that are early in their disease, diagnosed at earlier age, I think this will be a very important treatment as it saves them from the bleedings -- breakthrough bleedings that occur on lifelong treatment with infused factor.
對於處於疾病早期、在較早年齡被診斷出的患者,我認為這將是一種非常重要的治療方法,因為它可以使他們免於出血——在使用輸注因子進行終身治療時發生的突破性出血。
And particularly, for patients that are -- at early age that are very physically active, it is important to have a solution for cure.
特別是對於那些在早期身體活動非常活躍的患者,找到治癒的解決方案非常重要。
So I think this will be a tremendous important patient population.
所以我認為這將是一個非常重要的患者群體。
But the availability of subcutaneous agents will supplement them and also allow for patients that may have antibodies to gene therapies to use them until sufficient number of gene therapies available, that there is always one for each patient.
但皮下藥物的可用性將補充它們,並允許可能對基因療法產生抗體的患者使用它們,直到有足夠數量的基因療法可用,每個患者總是有一個。
And finally, as bringing together, I think what's unique with us is the entire portfolio that can address these patients.
最後,作為匯集,我認為我們的獨特之處在於可以解決這些患者的整個產品組合。
And we look really much forward to there around 2021 and '22 when we see this portfolio coming into registration phase.
當我們看到這個投資組合進入註冊階段時,我們非常期待 2021 年和 22 年左右。
I think that was the main piece here.
我認為這是這裡的主要部分。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes.
是的。
And then, Angela, maybe on VYNDAQEL.
然後,安吉拉,也許在 VYNDAQEL。
We have seen some uptick in markets that cardiomyopathy was not approved.
我們已經看到心肌病未被批准的市場出現了一些上漲。
What is going on there and about supplement and filing on polyneuropathy?
那裡發生了什麼以及關於多發性神經病的補充和歸檔?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Yes.
是的。
In terms of polyneuropathy in the U.S., this is something that we're continuing to explore with the FDA.
就美國的多發性神經病而言,這是我們與 FDA 繼續探索的問題。
So...
所以...
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
No decision can be made yet, but you are in discussion.
目前還不能做出決定,但你們正在討論中。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
That's right.
這是正確的。
Exactly.
確切地。
And then in terms of the upticks in polyneuropathy, I mean, I'm not sure that it's a cardiomyopathy effect.
然後就多發性神經病的增加而言,我的意思是,我不確定這是心肌病的影響。
As you know, we are approved.
如你所知,我們被批准了。
It's an approved indication for us ex-U.
這是我們前美國批准的適應症。
S. So we continue to actively promote it, and it's probably as a result of those activities.
S. 所以我們繼續積極推廣它,這可能是這些活動的結果。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes.
是的。
We will have, as we said, approval for that indication, and this is one that we will see material impacts on VYNDAQEL, in cardiomyopathy in these patients.
正如我們所說,我們將獲得對該適應症的批准,這是我們將在這些患者的心肌病中看到對 VYNDAQEL 的實質性影響的一種。
We are not right now.
我們現在不是。
We are just promoting, of course, the indications, but we have registered for that, so we don't do anything outside that.
當然,我們只是在宣傳這些適應症,但我們已經為此註冊了,所以我們不會做任何其他事情。
All right.
好的。
I think this concludes more or less our call.
我認為這或多或少地結束了我們的呼籲。
Just I wanted to make some comments because really, I feel that we are at an exciting point in Pfizer's history.
我只是想發表一些評論,因為真的,我覺得我們正處于輝瑞歷史上一個激動人心的時刻。
And if you take a big picture view, over the last decade, we have changed and refocused our approach to R&D.
如果您放眼全局,在過去十年中,我們已經改變並重新關注了我們的研發方法。
We have improved dramatically its productivity, and we have developed the best pipeline we ever had and one of the best, I believe, in the industry.
我們已經顯著提高了它的生產力,我們開發了我們曾經擁有的最好的管道,我相信這是業內最好的管道之一。
If you've seen 2019, it was a year that we took deliberate and thoughtful steps to strengthen each one of our businesses and eventually shed the current Pfizer into a new, smaller, high-growth profile enterprise that will remain a powerhouse in marketing but also has been converted to the powerhouse of science.
如果你看過 2019 年,那一年我們採取了深思熟慮的措施來加強我們的每一項業務,並最終將目前的輝瑞公司轉變為一家新的、規模較小、高增長的企業,該企業仍將是營銷強國,但也已轉變為科學的強國。
Following the expected close of the Upjohn and Mylan transaction later this year, of course, we will be a very different company.
當然,在今年晚些時候 Upjohn 和 Mylan 交易的預期結束之後,我們將成為一家非常不同的公司。
And we will focus on continuing to execute our strategy.
我們將專注於繼續執行我們的戰略。
This includes: We will continue the commercial momentum and preparing our new product launches.
這包括:我們將繼續保持商業勢頭並準備我們的新產品發布。
You have all asked a lot of questions about those products that keep surprising with our growth profile.
你們都問了很多關於那些讓我們的增長狀況令人驚訝的產品的問題。
And also, you've seen that we are taking seriously and we are investing in new launches.
而且,您已經看到我們正在認真對待並且我們正在投資新的發布。
We are continuing advancing our internal pipeline, and we'll augment it with mid-stage R&D programs through targeted bolt-on business development opportunities.
我們正在繼續推進我們的內部管道,我們將通過有針對性的附加業務發展機會通過中期研發計劃來增強它。
As I referenced before, you should continue seeing these type of activities in the first and second half of this year.
正如我之前提到的,你應該在今年上半年和下半年繼續看到這些類型的活動。
Of course, we are working very intensively to set up Upjohn to be in a strong position when it combines with Mylan to become Viatris and create a formidable company.
當然,我們正在加緊努力以建立 Upjohn,以便在與 Mylan 合併成為 Viatris 並創建一家強大的公司時處於強勢地位。
And of course, we will continue leading the conversation in Washington as we work to address the affordability challenge facing patients.
當然,我們將繼續在華盛頓領導對話,努力解決患者面臨的負擔能力挑戰。
These are the areas that we are focusing for next year.
這些是我們明年重點關注的領域。
Once again, we look forward to sharing more pipeline updates during our Investor Day on March 31.
再次,我們期待在 3 月 31 日的投資者日期間分享更多管道更新。
Have a great rest of your day.
好好休息一天。
Operator
Operator
Ladies and gentlemen, this does conclude Pfizer's Fourth Quarter 2019 Earnings Conference Call.
女士們先生們,輝瑞公司 2019 年第四季度財報電話會議就此結束。
Thank you for your participation.
感謝您的參與。
You may now disconnect.
您現在可以斷開連接。