輝瑞 (PFE) 2019 Q3 法說會逐字稿

完整原文

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

  • Operator

    Operator

  • Good day, everyone, and welcome to Pfizer's Third Quarter 2019 Earnings Conference Call.

    大家好,歡迎來到輝瑞 2019 年第三季度收益電話會議。

  • Today's call is being recorded.

    今天的通話正在錄音中。

  • At this time, I would like to turn the call over to Mr. Chuck Triano, Senior Vice President of Investor Relations.

    在這個時候,我想把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

  • Good morning and thank you for joining us today to review Pfizer's third quarter 2019 performance and updated 2019 financial guidance.

    早上好,感謝您今天加入我們,回顧輝瑞 2019 年第三季度的業績和更新的 2019 年財務指南。

  • I'm joined today by our CEO, 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 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.

    您會在此處看到幻燈片 3 涵蓋了我們的法律披露。

  • Albert and Frank will now make prepared remarks, and then we'll move to a question-and-answer session.

    Albert 和 Frank 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,我現在將電話轉給 Albert Bourla。

  • Albert?

    艾伯特?

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Thank you, Chuck, and good morning, everyone.

    謝謝查克,大家早上好。

  • During my remarks, I will discuss our quarterly business performance, the latest updates from our pipeline and our plans for Pfizer following the anticipated completion of the Upjohn-Mylan combination, which we continue to expect to occur in mid-2020.

    在我的發言中,我將討論我們的季度業務表現、我們管道的最新更新以及我們在 Upjohn-Mylan 合併預期完成後對輝瑞的計劃,我們繼續預計該合併將在 2020 年年中完成。

  • During the quarter, we delivered a strong performance, highlighted by 9% operational revenue growth in our Pfizer Biopharmaceuticals Group, which will be the business that remains at Pfizer following the anticipated closing of the Upjohn transaction.

    本季度,我們取得了強勁的業績,突出表現在我們的輝瑞生物製藥集團的營業收入增長了 9%,這將是在 Upjohn 交易預期結束後保留在輝瑞的業務。

  • We also saw revenue impacted by 2 expected events, the July loss of exclusivity in the U.S. for Lyrica and the July 31 completion of the Consumer Healthcare joint venture transaction with GSK.

    我們還看到收入受到 2 個預期事件的影響,7 月 Lyrica 在美國失去獨家經營權,以及 7 月 31 日完成與 GSK 的消費者保健合資交易。

  • For Biopharmaceuticals, once again, this group's outstanding growth was driven primarily by strong performance from our key growth drivers.

    對於生物製藥,該集團的出色增長再次主要得益於我們主要增長動力的強勁表現。

  • This includes Ibrance, Xtandi, Xeljanz, Eliquis, VYNDAQEL and Inlyta as well as 15% operational growth in emerging markets, including 42% operational growth in China.

    這包括 Ibrance、Xtandi、Xeljanz、Eliquis、VYNDAQEL 和 Inlyta,以及新興市場 15% 的運營增長,其中包括中國 42% 的運營增長。

  • Our Biopharmaceutical business in China generated higher revenue this quarter than the Upjohn business in the country.

    我們在中國的生物製藥業務本季度的收入高於國內的 Upjohn 業務。

  • Our Oncology business was particularly strong, up 30% operationally compared with the year ago quarter.

    我們的腫瘤業務特別強勁,與去年同期相比增長了 30%。

  • Global revenues for Ibrance were up 27% operationally in the quarter to $1.3 billion.

    本季度 Ibrance 的全球運營收入增長了 27%,達到 13 億美元。

  • We saw strong revenue growth in both U.S. and international markets.

    我們在美國和國際市場都看到了強勁的收入增長。

  • We believe the continued growth in the U.S. is the result of our effort to target specific physicians who have not been prescribing CDK inhibitors or had prescribed them to only a small set of patients.

    我們認為,在美國的持續增長是我們努力瞄準特定醫生的結果,這些醫生沒有開過 CDK 抑製劑,或者只給一小部分患者開過 CDK 抑製劑。

  • For Xtandi, the alliance revenues in the U.S. grew 25% to $225 million.

    對於 Xtandi,聯盟在美國的收入增長了 25%,達到 2.25 億美元。

  • In August, the FDA granted Xtandi a priority review designation for the treatment of men with metastatic hormone-sensitive prostate cancer with a PDUFA date in December.

    8 月,FDA 授予 Xtandi 優先審評資格,用於治療 PDUFA 日期為 12 月的轉移性激素敏感性前列腺癌男性。

  • If approved, this represents yet another potential growth driver for the brand.

    如果獲得批准,這將代表該品牌的另一個潛在增長動力。

  • Inlyta revenues increased 98% operationally to $139 million.

    Inlyta 的運營收入增長了 98%,達到 1.39 億美元。

  • This included 240% growth in the U.S. where Inlyta has benefited from recent FDA approvals for the combination of Inlyta plus BAVENCIO and Inlyta plus KEYTRUDA in first-line treatment of advanced renal cell carcinoma patients.

    這包括美國 240% 的增長,Inlyta 受益於最近 FDA 批准將 Inlyta 加 BAVENCIO 和 Inlyta 加 KEYTRUDA 聯合用於晚期腎細胞癌患者的一線治療。

  • Beyond oncology, we had several other strong product performances.

    除了腫瘤學,我們還有其他幾個強大的產品性能。

  • Global revenues for Xeljanz were up 40% operationally to $599 million.

    Xeljanz 的全球運營收入增長了 40%,達到 5.99 億美元。

  • We saw continued volume growth in the rheumatoid arthritis indication, and the recent launches for psoriatic arthritis in the U.S. and for ulcerative colitis in both the U.S. and certain other developed markets also significantly contributed to the growth.

    我們看到類風濕性關節炎適應症的銷量持續增長,最近在美國推出的銀屑病關節炎和美國及其他某些發達市場的潰瘍性結腸炎也對增長做出了重大貢獻。

  • Eliquis also continued to perform well.

    Eliquis 也繼續表現良好。

  • Global revenues were up 20% operationally to $1 billion.

    全球運營收入增長了 20%,達到 10 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所推動的。

  • Looking at our Rare Diseases 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.

    在 2019 年 5 月獲得批准和上市後,VYNDAQEL 在美國繼續保持良好勢頭。

  • Our early disease awareness efforts have helped drive the diagnosis rates to greater than 4% in the quarter compared with 1% prior to launch.

    我們的早期疾病意識工作幫助將本季度的診斷率從發布前的 1% 提高到 4% 以上。

  • As of end of August, approximately 4,100 patients had been diagnosed, approximately 2,600 patients had received the prescription for VYNDAQEL and approximately 1,300 patients had received the drug.

    截至 8 月底,約有 4,100 名患者被確診,約 2,600 名患者收到了 VYNDAQEL 的處方,約有 1,300 名患者接受了該藥物。

  • This number does not include the early access program.

    此數字不包括搶先體驗計劃。

  • If you include this, the number of patients receiving the drug increases to approximately 1,500.

    如果將其包括在內,接受藥物治療的患者人數將增加到大約 1,500 人。

  • Regarding Prevnar 13.

    關於 Prevnar 13。

  • Revenues were down slightly across the global franchise.

    全球特許經營的收入略有下降。

  • ACIP's updated recommendation in the U.S. for the vaccine for adults 65 and older, which is not effective until the publication of the morbidity and mortality weekly report, reinforces that Prevnar 13 is considered safe and effective by both the FDA and ACIP.

    ACIP 在美國針對 65 歲及以上成年人接種疫苗的最新建議在發病率和死亡率每週報告發布後才生效,這進一步表明 FDA 和 ACIP 都認為 Prevnar 13 是安全有效的。

  • We look forward to successfully completing the Phase 3 studies for our investigational 20-valent pneumococcal conjugate vaccine candidate.

    我們期待著成功完成我們正在研究的 20 價肺炎球菌結合疫苗候選疫苗的第 3 階段研究。

  • This candidate represents a potential significant advancement compared with the potential 15-valent by introducing all serotypes contained in PCV-15 plus 5 additional serotypes.

    通過引入 PCV-15 中包含的所有血清型加上 5 個額外的血清型,與潛在的 15 價相比,該候選物代表了潛在的重大進步。

  • In Sterile Injectables, we are seeing our focus on manufacturing recovery taking shape.

    在無菌注射劑中,我們看到我們對製造業復甦的關注正在形成。

  • Global revenues increased 3% operationally and U.S. revenues increased 1% operationally.

    全球運營收入增長 3%,美國運營收入增長 1%。

  • We continue to expect this business to be a solid growth contributor in the future.

    我們繼續期望該業務在未來成為穩健的增長貢獻者。

  • Now let me move to Upjohn.

    現在讓我轉到 Upjohn。

  • Revenues for our Upjohn business were down 26% operationally in the quarter.

    本季度,我們 Upjohn 業務的運營收入下降了 26%。

  • The decline was driven primarily by the expected significant volume declines in Lyrica in the U.S. due to multisource generic competition that began in July 2019.

    下降的主要原因是,由於 2019 年 7 月開始的多源仿製藥競爭,預計美國 Lyrica 的銷量將大幅下降。

  • Excluding the Lyrica impact, the decline would have been only 6% operationally.

    排除 Lyrica 的影響,運營下降幅度僅為 6%。

  • Upjohn's China revenues increased 2% operationally despite the volume-based procurement program in the 11 cities.

    儘管在 11 個城市實施了基於數量的採購計劃,但 Upjohn 在中國的運營收入仍增長了 2%。

  • Given this, we now expect Upjohn's full year 2019 revenues in China to grow by mid- to high single digits compared with full year 2018 instead of low to mid-single digits that we had predicted in our previous earnings call.

    鑑於此,我們現在預計 Upjohn 2019 年全年在中國的收入將比 2018 年全年增長中高個位數,而不是我們在之前的財報電話會議中預測的中低個位數。

  • Consumer Healthcare.

    消費者保健。

  • For third quarter 2019, revenues totaled $377 million, down 54% operationally, reflecting the July 31, 2019, completion of the Consumer Healthcare joint venture transaction with GSK.

    2019 年第三季度,收入總計 3.77 億美元,運營收入下降 54%,反映了 2019 年 7 月 31 日與葛蘭素史克 (GSK) 完成的消費者保健合資交易。

  • Turning now to R&D.

    現在轉向研發。

  • We continue to be excited with the progress we are making with our pipeline, both in terms of the breadth of opportunities and the depth of the science.

    我們繼續對我們在管道方面取得的進展感到興奮,無論是在機會的廣度還是在科學的深度方面。

  • Since our last earnings call on July 29, we have seen some exciting milestones.

    自我們上次於 7 月 29 日召開財報電話會議以來,我們已經看到了一些令人興奮的里程碑。

  • In Vaccines, we announced positive preliminary results from a proof of concept Phase 2 study of our investigational 20-valent pneumococcal conjugate vaccine under investigation for the prevention of invasive disease and otitis media in healthy infants.

    在疫苗方面,我們宣布了我們正在研究的用於預防健康嬰兒侵襲性疾病和中耳炎的研究性 20 價肺炎球菌結合疫苗的概念驗證階段 2 研究的積極初步結果。

  • Once data with the fourth dose are available, we intend to discuss Phase 3 plans with regulators.

    一旦獲得第四劑的數據,我們打算與監管機構討論第三階段計劃。

  • We also have completed enrollment in our 3 Phase 3 pivotal clinical trials evaluating our investigational 20-valent vaccine for the prevention of invasive disease and pneumonia in adults 18 years and older.

    我們還完成了 3 項 3 期關鍵臨床試驗的註冊,該試驗評估了我們用於預防 18 歲及以上成人侵襲性疾病和肺炎的研究性 20 價疫苗。

  • In Rare Diseases, we completed the transfer from Sangamo to Pfizer of the manufacturing processes for the investigational SB-525 gene therapy for severe hemophilia A. This month, we have enrolled the first patient in the lead-in trial of the Phase 3 clinical program.

    在罕見病領域,我們完成了從 Sangamo 到輝瑞公司的轉移,用於治療嚴重血友病 A 的研究 SB-525 基因療法的製造工藝。本月,我們在 3 期臨床項目的導入試驗中招募了第一位患者.

  • We expect to begin dosing patients for that trial in the first half of 2020.

    我們預計將在 2020 年上半年開始為該試驗的患者給藥。

  • On October 21, Pfizer announced jointly with our partner, OPKO, that the global Phase 3 trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency met its primary endpoint of noninferiority to daily injectable GENOTROPIN.

    10 月 21 日,輝瑞公司與我們的合作夥伴 OPKO 聯合宣布,全球 3 期試驗評估了生長激素缺乏症的青春期前兒童每週一次服用 somatrogon 的主要終點,即非劣於每日註射的 GENOTROPIN。

  • We are very pleased with the results because this potential once weekly solution may offer significant benefits to patients.

    我們對結果非常滿意,因為這種潛在的每週一次的解決方案可能會給患者帶來顯著的好處。

  • We are looking forward to presenting detailed data in a scientific conference and discussing them with the FDA and other regulators.

    我們期待在科學會議上展示詳細數據,並與 FDA 和其他監管機構進行討論。

  • In Inflammation & Immunology, we recently announced positive top line results from JADE Mono-2.

    在炎症與免疫學方面,我們最近公佈了 JADE Mono-2 的正面頂線結果。

  • This was the second Phase 3 pivotal study evaluating the efficacy and safety of our oral JAK1 inhibitor abrocitinib in patients with moderate to severe atopic dermatitis.

    這是第二個 3 期關鍵研究,評估我們的口服 JAK1 抑製劑阿布西替尼在中度至重度特應性皮炎患者中的療效和安全性。

  • These findings are in addition to the positive results for our first Phase 3 study with abrocitinib in this indication where the full data were presented earlier this month at a medical conference.

    這些發現是對我們在該適應症中使用 abrocitinib 進行的第一個 3 期研究的積極結果的補充,該適應症的完整數據已在本月早些時候的一次醫學會議上公佈。

  • In internal medicine, we recently entered into a worldwide exclusive licensing agreement with Akcea Therapeutics for AKCEA-ANGPTL3-LRx, an investigational antisense therapy being developed to treat patients with the certain cardiovascular and metabolic diseases.

    在內科領域,我們最近與 Akcea Therapeutics 就 AKCEA-ANGPTL3-LRx 達成了一項全球獨家許可協議,這是一種正在開發的研究性反義療法,用於治療患有某些心血管和代謝疾病的患者。

  • The therapy is currently being evaluated in a Phase 2 study in patients with type 2 diabetes, hypertriglyceridemia and nonalcoholic fatty liver disease.

    該療法目前正在 2 型糖尿病、高甘油三酯血症和非酒精性脂肪肝患者的 2 期研究中進行評估。

  • We believe this novel therapy will complement our clinical mid-stage internal medicine pipeline and that our deep expertise in cardiovascular and metabolic diseases will help allow this program to reach its maximum potential for patients.

    我們相信這種新療法將補充我們的臨床中期內科管道,我們在心血管和代謝疾病方面的深厚專業知識將有助於使該項目為患者發揮最大潛力。

  • Lastly, in Oncology, from our recent acquisition of Array, we've presented interim analysis results from the Phase 3 BEACON trial of BRAFTOVI, MEKTOVI and cetuximab for the treatment of BRAF V600E mutant metastatic colorectal cancer.

    最後,在腫瘤學方面,根據我們最近對 Array 的收購,我們展示了 BRAFTOVI、MEKTOVI 和西妥昔單抗治療 BRAF V600E 突變轉移性結直腸癌的 3 期 BEACON 試驗的中期分析結果。

  • BRAFTOVI combinations saw statistically significant improvements in overall survival and objective response rates versus control.

    與對照組相比,BRAFTOVI 組合在總體生存率和客觀反應率方面有統計學意義的改善。

  • We recently submitted to the FDA a supplementary New Drug Application with this data.

    我們最近向 FDA 提交了一份包含這些數據的補充新藥申請。

  • And as per our user practice, we will announce their decision regarding acceptance for review.

    根據我們的用戶慣例,我們將宣布他們關於接受審查的決定。

  • And I am pleased to say that we now have U.S. launch days for 3 of our biosimilars recently approved by the FDA.

    我很高興地說,我們現在有 3 種最近獲得 FDA 批准的生物仿製藥在美國上市。

  • ZIRABEV is expected to launch on December 31 of this year 2019, Ruxience in January of 2020 and TRAZIMERA on February 15, 2020, so all in the near future.

    ZIRABEV 預計將於 2019 年今年 12 月 31 日推出,Ruxience 將於 2020 年 1 月推出,TRAZIMERA 將於 2020 年 2 月 15 日推出,所以都在不久的將來。

  • Of course, none of our breakthroughs will do patients any good if patients can't afford them.

    當然,如果患者負擔不起,我們的任何突破都不會對患者有任何好處。

  • Pfizer remains committed to working with policymakers at both the federal and state levels and on both sides of the aisle on common sense solutions to improve patient affordability.

    輝瑞(Pfizer)將繼續致力於與聯邦和州一級以及兩黨的政策制定者合作,制定常識性解決方案,以提高患者的負擔能力。

  • We are making progress in certain areas.

    我們正在某些領域取得進展。

  • For example, our proposals regarding biosimilars have been well received, and bipartisan legislation on this issue is advancing.

    例如,我們關於生物仿製藥的提案得到了很好的反響,兩黨在這個問題上的立法也在推進中。

  • We also continue to work with policymakers and others in the health care system to find ways to reduce out-of-pocket costs at the pharmacy counter, especially for seniors.

    我們還繼續與醫療保健系統的政策制定者和其他人員合作,尋找減少藥房櫃檯自付費用的方法,尤其是對老年人而言。

  • We are particularly encouraged that lawmakers recognize the need for an annual out-of-pocket cap in Medicare Part D. And we are aggressively pursuing value-based arrangements that tie reimbursement to the ability of our medicines to produce positive outcomes for patients.

    我們特別感到鼓舞的是,立法者認識到需要在 Medicare D 部分設置年度自付費用上限。我們正在積極尋求基於價值的安排,將報銷與我們的藥物為患者產生積極結果的能力聯繫起來。

  • While there has been a lot of discussion around less constructive proposals, it's difficult to imagine Congress supporting policies that will explicitly stand in the way of lifesaving medicines being developed and made available to American patients.

    儘管圍繞較不具建設性的提案進行了大量討論,但很難想像國會支持的政策會明確阻礙救生藥物的開發並提供給美國患者。

  • Therefore, we remain confident that common sense solutions can be found that will drive continued innovation and benefit patients.

    因此,我們仍然有信心找到常識性解決方案,以推動持續創新並造福患者。

  • In summary, we turned in another solid quarter, and our pipeline continues to be a source of great hope and excitement for our company, our shareholders and the patients who rely on our innovative medicines and vaccines.

    總而言之,我們又迎來了一個穩定的季度,我們的管道繼續為我們公司、我們的股東以及依賴我們的創新藥物和疫苗的患者帶來巨大的希望和興奮。

  • We also raised the midpoints for our 2019 revenue and adjusted diluted EPS guidance ranges to reflect our strong performance today as well as our confidence of the business going forward.

    我們還提高了 2019 年收入的中點並調整了攤薄後每股收益指導範圍,以反映我們今天的強勁表現以及我們對未來業務的信心。

  • Frank will provide more details on this in a moment.

    稍後,Frank 將提供更多詳細信息。

  • Following the expected close of the Upjohn-Mylan transaction next year, Pfizer will be a smaller science-based company with a singular focus on innovative biopharma.

    預計明年 Upjohn-Mylan 交易完成後,輝瑞將成為一家規模較小的科學型公司,專注於創新生物製藥。

  • All our current growth drivers and pipeline will remain with Pfizer for this reason, and we expect Pfizer's 5-year revenue CAGR to be approximately 6% and for that growth to begin immediately upon the close of the transaction.

    出於這個原因,我們目前所有的增長動力和管道都將留在輝瑞,我們預計輝瑞的 5 年收入複合年增長率約為 6%,並且該增長將在交易結束後立即開始。

  • Our Biopharmaceuticals Group is already growing at a similar pace.

    我們的生物製藥集團已經在以類似的速度增長。

  • Starting in 2026, we will have a new set of LOEs, but we expect the new wave of compounds currently in the pipeline, along with the acquisitions of Therachon and Array Therapeutics, our equity interest in Vivet Therapeutics and the in-license investigational therapy from Akcea to help mitigate the impact of these LOEs.

    從 2026 年開始,我們將擁有一套新的 LOE,但我們預計目前正在研發的新一波化合物,以及對 Therachon 和 Array Therapeutics 的收購、我們在 Vivet Therapeutics 的股權以及來自Akcea 有助於減輕這些 LOE 的影響。

  • These agreements represent the types of targeted BD initiatives we will continue to pursue to help strengthen our substrate for the second half of the next decade.

    這些協議代表了我們將繼續追求的目標 BD 計劃的類型,以幫助加強我們在下一個十年下半年的基礎。

  • These are deliberate moves we are making because of the confidence we have in our science, in our ability to commercialize important new medicines and vaccines and in our ability to continue to invest in growth while returning capital to investors.

    這些都是我們深思熟慮的舉措,因為我們對我們的科學、我們將重要的新藥和疫苗商業化的能力以及我們在向投資者返還資本的同時繼續投資於增長的能力充滿信心。

  • Now let me turn it over to Frank to provide details on the quarter and our outlook for the remainder of 2019.

    現在讓我把它交給弗蘭克,提供有關本季度的詳細信息以及我們對 2019 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,艾伯特。

  • Good day, everyone.

    今天是個好日子。

  • The charts I am reviewing today are available on our website.

    我今天正在查看的圖表可以在我們的網站上找到。

  • Now moving on to business performance.

    現在轉向業務績效。

  • Our Biopharmaceuticals Group business recorded 9% operational revenue growth in the third quarter of 2019 driven primarily by Ibrance globally, which recorded revenues of nearly $1.3 billion, an operational increase of 27%.

    我們的生物製藥集團業務在 2019 年第三季度實現了 9% 的營業收入增長,這主要受全球 Ibrance 的推動,其收入接近 13 億美元,營業收入增長了 27%。

  • This was composed of 48% operational growth in international markets and 18% growth in the U.S.

    這包括國際市場 48% 的運營增長和美國 18% 的增長。

  • Xeljanz globally, up 40% operationally, primarily driven by 34% growth in the U.S. as well as 61% operational growth in international markets.

    Xeljanz 在全球範圍內的運營增長了 40%,主要受美國 34% 的增長以及國際市場 61% 的運營增長推動。

  • Eliquis globally, up 20% operationally; the hospital business, up 9% operationally in Emerging Markets and the U.S., primarily driven by continued growth from anti-infective products in China and the November 2018 U.S. launch of PANZYGA.

    Eliquis 全球業務增長 20%;醫院業務在新興市場和美國的運營增長了 9%,這主要是由於中國抗感染產品的持續增長以及 2018 年 11 月在美國推出的 PANZYGA。

  • VYNDAQEL with sales of $156 million in the quarter with $79 million in the U.S. following the launch of cardiomyopathy; and Inlyta in the U.S. where revenues increased to $139 million, primarily driven by increased utilization in combination with certain checkpoint inhibitors for the first-line treatment of patients with advanced renal cell carcinoma, partially offset primarily by lower revenues for Enbrel internationally, down 19% operationally, primarily reflecting continued biosimilar competition in most developed European markets; and Prevnar 13 in the U.S. down 7% due to lower government pediatric purchases in the third quarter of 2019 and continued decline in revenues for the adult indication.

    VYNDAQEL 本季度銷售額為 1.56 億美元,其中在推出心肌病藥物後在美國的銷售額為 7900 萬美元;和 Inlyta 在美國的收入增加到 1.39 億美元,這主要是由於與某些檢查點抑製劑聯合用於晚期腎細胞癌患者一線治療的利用率增加,部分抵消了 Enbrel 國際收入下降 19%在運營方面,主要反映了大多數發達歐洲市場的持續生物仿製藥競爭;由於 2019 年第三季度政府兒科採購減少以及成人適應症的收入持續下降,美國的 Prevnar 13 下降了 7%。

  • Revenues for our Upjohn business in the third quarter decreased to 26% operationally, primarily driven by the expected significant volume declines from Lyrica in the U.S. associated with multisource generic competition that began in July of 2019.

    我們第三季度 Upjohn 業務的運營收入下降至 26%,這主要是由於美國 Lyrica 的預期銷量大幅下降與 2019 年 7 月開始的多源仿製藥競爭有關。

  • Excluding the unfavorable impact of Lyrica in the U.S., third quarter 2019 revenues for Upjohn declined 6% operationally due to continued generic competition for certain off-patent products.

    排除 Lyrica 在美國的不利影響,由於某些非專利產品的持續仿製藥競爭,Upjohn 2019 年第三季度的運營收入下降了 6%。

  • These results were partially offset by revenues in China, up 2% operationally, primarily driven by volume growth for Lipitor and Norvasc in provinces where the volume-based procurement program has not yet been implemented as well as operational growth from Viagra and partially offset primarily by volume declines and unfavorable pricing impact in cities where the VBP program was implemented in March of 2019.

    這些結果被中國的收入部分抵消,運營增長 2%,這主要是由於立普妥和諾華在尚未實施基於數量的採購計劃的省份的銷量增長以及偉哥的業務增長所推動,部分抵消主要是2019 年 3 月實施 VBP 計劃的城市的銷量下降和不利的定價影響。

  • Pfizer now expects Upjohn revenues in China to grow operationally by mid- to high single digits for the full year of 2019 compared with 2018.

    輝瑞現在預計,與 2018 年相比,普強 2019 年全年在中國的營業收入將實現中高個位數增長。

  • Revenues for the Consumer Healthcare business in the third quarter are not comparable with the third quarter of last year due to the completion of the Consumer Healthcare joint venture transaction with GlaxoSmithKline.

    由於完成了與葛蘭素史克的消費者保健合資交易,第三季度消費者保健業務的收入與去年第三季度不可比。

  • This quarter's reporting reflects approximately 1 month of Consumer Healthcare domestic operations and approximately 2 months of Consumer Healthcare financial operations versus third quarter of 2018 revenues, which reflect the full 3 months of Consumer Healthcare global operations.

    本季度的報告反映了大約 1 個月的 Consumer Healthcare 國內業務和大約 2 個月的 Consumer Healthcare 財務業務與 2018 年第三季度的收入,後者反映了 Consumer Healthcare 全球業務的整整 3 個月。

  • In addition, Pfizer recognized an $8.1 billion pretax gain upon the completion of the Consumer Healthcare joint venture transaction, which reflects the difference in the fair value of Pfizer's 32% equity stake in the joint venture compared to the carrying value of the Consumer Healthcare business.

    此外,輝瑞在消費者保健合資交易完成後確認了 81 億美元的稅前收益,這反映了輝瑞在合資企業中 32% 股權的公允價值與消費者保健業務賬面價值之間的差異。

  • Finally, diluted weighted average shares outstanding declined by approximately 337 million shares to 5.65 billion versus the year ago quarter, primarily due to Pfizer's ongoing share repurchase program, reflecting the impact of share repurchases during 2018 and 2019, partially offset by dilution related to share-based employee compensation programs.

    最後,與去年同期相比,稀釋後的加權平均流通股減少了約 3.37 億股,至 56.5 億股,這主要是由于輝瑞正在進行的股票回購計劃,反映了 2018 年和 2019 年股票回購的影響,部分被與股票相關的稀釋所抵消-基於員工薪酬計劃。

  • Foreign exchange negatively impacted third quarter 2019 revenues by approximately $215 million in adjusted cost of sales and positively impacted adjusted SI&A and adjusted R&D expenses.

    外匯對 2019 年第三季度收入的調整後銷售成本產生了約 2.15 億美元的負面影響,並對調整後的 SI&A 和調整後的研發費用產生了積極影響。

  • In aggregate, foreign exchange had a $0.02 per share negative impact on adjusted diluted EPS compared to the year ago quarter.

    總體而言,與去年同期相比,外匯對調整後的攤薄每股收益產生了 0.02 美元的負面影響。

  • Moving on to 2019 financial guidance.

    繼續進行 2019 年財務指導。

  • We raised the midpoint of our 2019 guidance range for revenues by $200 million to $51.2 billion to $52.2 billion composed of $400 million of operational revenue growth, partially offset by a $200 million unfavorable impact from changes in foreign exchange.

    我們將 2019 年收入指導範圍的中點提高了 2 億美元至 512 億美元至 522 億美元,其中 4 億美元的營業收入增長部分被外匯變化帶來的 2 億美元的不利影響所抵消。

  • (technical difficulty)

    (技術難度)

  • Sorry for the technical problems, everyone.

    抱歉,技術問題,大家。

  • So let me continue.

    讓我繼續。

  • It's Frank.

    是弗蘭克。

  • In addition, we now expect the adjusted cost of sales to be in the range of 19.3% to 19.8%; adjusted SI&A expenses to be in the range of $13.5 billion to $14 billion; adjusted R&D expenses to be in the range of $7.7 billion to $8.1 billion; and adjusted EPS to be in the range of $2.94 to $3 from $2.76 to $2.86, an increase of $0.16 since the previous quarter, reflecting an $0.18 operational improvement, partially offset by a $0.02 unfavorable impact from recent changes and foreign exchange rates.

    此外,我們現在預計調整後的銷售成本將在 19.3% 至 19.8% 之間;調整後的 SI&A 費用在 135 億美元至 140 億美元之間;調整後的研發費用在 77 億美元至 81 億美元之間;調整後的每股收益從 2.76 美元到 2.86 美元從 2.94 美元到 3 美元不等,比上一季度增加了 0.16 美元,反映出 0.18 美元的運營改善,部分被近期變化和匯率帶來的 0.02 美元的不利影響所抵消。

  • This guidance assumes diluted weighted average shares outstanding of approximately 5.7 billion shares, which reflects the weighted average impact of share repurchases totaling 8.9 billion executed in 2019.

    本指南假設稀釋後加權平均流通股約為 57 億股,這反映了 2019 年執行的總計 89 億股股票回購的加權平均影響。

  • Dilution related to share-based employee compensation program is currently expected to offset the reduction of shares associated with these share repurchases by approximately half.

    與基於股份的員工薪酬計劃相關的稀釋目前預計將抵消與這些股份回購相關的股份減少約一半。

  • Our 2019 guidance for adjusted other income deducts and the effective tax rate on adjusted income did not change.

    我們 2019 年調整後其他收入扣除指南和調整後收入的實際稅率沒有改變。

  • We continue to expect adjusted operating income deducts to be $200 million of income and the effective tax rate to be approximately 16%.

    我們繼續預計調整後的營業收入扣除額為 2 億美元,有效稅率約為 16%。

  • Now moving on to key takeaways.

    現在繼續討論要點。

  • We delivered a strong quarter.

    我們交付了一個強勁的季度。

  • Revenues for the Pfizer Biopharmaceuticals Group grew 9% operationally versus the year ago quarter driven by Ibrance, Xeljanz, Eliquis, VYNDAQEL, Inlyta and Xtandi.

    在 Ibrance 、 Xeljanz 、 Eliquis 、 VYNDAQEL 、 Inlyta 和 Xtandi 的推動下,輝瑞生物製藥集團的運營收入比去年同期增長了 9%。

  • We updated our 2019 financial guidance, increasing the midpoint of our adjusted EPS guidance range by $0.18 operationally.

    我們更新了 2019 年的財務指引,將調整後的 EPS 指引範圍的中點在運營上提高了 0.18 美元。

  • We accomplished multiple product and pipeline milestones since our previous quarterly update, and we returned $14.9 billion to shareholders through the third quarter through a combination of dividends and share repurchases.

    自上一季度更新以來,我們實現了多個產品和管道里程碑,並且通過股息和股票回購相結合,我們在第三季度向股東返還了 149 億美元。

  • Finally, we remain committed to delivering attractive shareholder returns in 2019 and beyond.

    最後,我們仍然致力於在 2019 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

  • Thank you, Albert and Frank, for the prepared comments.

    感謝 Albert 和 Frank 準備好的評論。

  • Operator, can we please move to the Q&A session?

    接線員,我們可以轉到問答環節嗎?

  • Operator

    Operator

  • (Operator Instructions) Your first question comes from Chris Schott with JPMorgan.

    (操作員說明)您的第一個問題來自摩根大通的 Chris Schott。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • I guess just 2 here.

    我想這裡只有 2 個。

  • First, I know you're not giving 2020 guidance at this point.

    首先,我知道你現在沒有給出 2020 年的指導。

  • But relative to your initial 2020 comments maybe in Upjohn, maybe just give us any -- just flavor of terms of business trends or any franchises that are performing ahead or behind maybe some of the initial expectations?

    但是相對於您在 Upjohn 發表的 2020 年最初評論,也許只是給我們一些 - 只是商業趨勢條款的味道或任何表現領先或落後於最初預期的特許經營權?

  • And my second question was about kind of the next wave of pipeline opportunities.

    我的第二個問題是關於下一波管道機會的種類。

  • It -- because it seems to me, when I hear the enthusiasm you have about that pipeline, that there is a bit of a disconnect between Street expectations and Pfizer expectations on the pipeline.

    它——因為在我看來,當我聽到你對這條管道的熱情時,街道的期望和輝瑞對這條管道的期望之間有點脫節。

  • So when you look at that portfolio, are there assets in particular where you see a particular -- a gap relative to, I guess, what we're thinking versus your expectations as we kind of focus in on some of these updates over the next few years?

    因此,當您查看該投資組合時,是否有資產特別是在您看到特定的地方 - 我猜,相對於我們的想法與您的期望之間的差距,因為我們會在接下來的時間里關注其中的一些更新幾年?

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Well, thank you, Chris.

    好吧,謝謝你,克里斯。

  • Let me try to speak a little bit about your question on guidance of next year, and then I will ask also Frank to help me on that, and then we'll ask Mikael Dolsten to speak about pipeline.

    讓我試著談談你關於明年指導的問題,然後我會請 Frank 幫助我解決這個問題,然後我們會請 Mikael Dolsten 談談管道。

  • Let me start with the 2020 guidance.

    讓我從 2020 年指南開始。

  • We don't give guidance up before our Board approves our operating plan.

    在董事會批准我們的運營計劃之前,我們不會放棄指導。

  • And this every year happens in the mid of December of 20-- of every year.

    這每年都發生在每年 20 日的 12 月中旬。

  • And usually, we do it in the next earnings call that happen in January.

    通常,我們會在 1 月份的下一次財報電話會議上這樣做。

  • This year, in the mid of the year, in July, because of the transaction, we had to provide some financial targets for Upjohn.

    今年年中,7月份,因為交易的緣故,我們不得不為Upjohn提供一些財務目標。

  • As a result, we felt that it's going to be awkward if we do not give also some financial targets for the RemainCo in 2020.

    因此,我們認為,如果我們不在 2020 年也為 RemainCo 設定一些財務目標,那將會很尷尬。

  • But of course, we did that with a lot of unknowns and with great distance from the year of 2020.

    但當然,我們這樣做時有很多未知數,而且距離 2020 年還有很大距離。

  • So we were appropriately cautious, I would say.

    所以我們適當謹慎,我會說。

  • Since then, a lot of things happened and happened in the areas that we wanted to see how things could perform.

    從那時起,在我們想要了解事情如何執行的領域發生了很多事情。

  • For example, we were not certain how the ACIP recommendation for Prevnar would affect the adult business.

    例如,我們不確定 ACIP 對 Prevnar 的建議將如何影響成人業務。

  • We were not certain how the label for Xeljanz -- in the black box that we received, in the change in the label for Xeljanz, how that would affect the prescription habits of physicians.

    我們不確定 Xeljanz 的標籤如何——在我們收到的黑盒子裡,在 Xeljanz 標籤的變化中,這將如何影響醫生的處方習慣。

  • We were not sure how Ibrance effort that started in the beginning of this year to increase the market size rather than focus on increasing our own markets [are offering], and -- but have given very good results in the second quarter.

    我們不確定 Ibrance 如何在今年年初開始努力增加市場規模,而不是專注於增加我們自己的市場 [正在提供],並且 - 但在第二季度取得了非常好的結果。

  • We'll continue as we go into the third quarter.

    我們將在進入第三季度時繼續。

  • We were not certain how the newly approved Inlyta compared to BAVENCIO together with BAVENCIO and together with KEYTRUDA indication will transform into performance into the market.

    我們不確定新批准的 Inlyta 與 BAVENCIO 以及 BAVENCIO 和 KEYTRUDA 的適應症相比將如何轉化為市場表現。

  • And we were not certain how Xtandi new indications will perform and also how the new product, which is our VYNDAQEL in cardiomyopathy, eventually will do.

    我們不確定 Xtandi 新適應症的表現如何,也不確定新產品(即我們在心肌病中使用的 VYNDAQEL)最終將如何表現。

  • As a fact of the matter, all 6 of them did much better than what we were expecting.

    事實上,他們 6 個人的表現都比我們預期的要好得多。

  • And this is extremely, extremely positive, of course.

    當然,這是非常非常積極的。

  • We are not going provide now a guidance for next year, but definitely, things have improved compared to what we thought in the second quarter.

    我們現在不打算提供明年的指導,但可以肯定的是,與我們在第二季度的想法相比,情況有所改善。

  • Moving to Upjohn.

    搬到厄普約翰。

  • Also, the same sentiment.

    還有,同樣的心情。

  • We have provided $7.5 billion to $8 billion for next year, and we have said that we've spent way significantly lower than what Upjohn is doing now because we wanted to make sure that we incorporate the impact predominantly in China of the volume-based procurement system.

    我們為明年提供了 75 億至 80 億美元,我們已經說過,我們的支出遠低於 Upjohn 現在所做的,因為我們想確保我們將主要在中國的基於批量採購的影響納入其中系統。

  • And for the same reasons, we said that the second half of this year will be lower and -- but we'll try our growth in China in general to be low to single digits growth for China -- digits for China.

    出於同樣的原因,我們說今年下半年會更低,但我們會嘗試在中國總體上實現低至個位數的增長——中國的數字。

  • In fact, we're upgrading that now.

    事實上,我們現在正在升級它。

  • And we are saying that for this year, our growth will be mid- to high digits growth in China portion of the Upjohn business.

    我們說今年,我們的增長將是 Upjohn 業務中國部分的中高位數增長。

  • And again, we are not going to provide guidance for 2020 for Upjohn, but we will do that together with the total company in -- after our Board approves in mid-December.

    再說一次,我們不會為 Upjohn 提供 2020 年的指導,但我們將在董事會於 12 月中旬批准後與整個公司一起這樣做。

  • But we have updated the guidance for this year obviously because of the very good results for the third quarter.

    但我們顯然已經更新了今年的指導,因為第三季度的業績非常好。

  • Frank, anything to add, please?

    弗蘭克,有什麼要補充的嗎?

  • Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations

    Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations

  • I would just add 2 things.

    我只想添加兩件事。

  • One, our current expectations is we would provide guidance for 2020 like we typically do on our fourth quarter earnings call.

    第一,我們目前的預期是,我們將像通常在第四季度財報電話會議上那樣為 2020 年提供指導。

  • But the only other thing I would add is -- but please understand that we intend to improve upon the 2020 numbers that we've previously issued that we talked about that we're appropriately cautious for the reasons that Albert discussed.

    但我要補充的唯一一件事是——但請理解,我們打算改進我們之前發布的 2020 年數字,我們出於阿爾伯特討論的原因適當謹慎。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Thank you.

    謝謝。

  • Now from the financials, let's go to things that are driving the financials, which is our -- strength of our pipeline.

    現在從財務方面,讓我們來看看推動財務的事情,這是我們的管道優勢。

  • So Mikael Dolsten, please go ahead.

    Mikael Dolsten,請繼續。

  • Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

    Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical

  • Thank you, Albert.

    謝謝你,艾伯特。

  • So let me say a few words.

    所以讓我說幾句。

  • First, we have a large and strong pipeline with 98 projects from Phase 1 through registration, and the uptick is contribution from all of our 5 therapeutic areas.

    首先,我們有一個龐大而強大的管道,從第一階段到註冊,有 98 個項目,而增長是我們所有 5 個治療領域的貢獻。

  • And it is driven by multiple science franchises and not dependent on 1 or 2 vulnerable compounds.

    它由多個科學專營權驅動,而不依賴於 1 或 2 種易受攻擊的化合物。

  • Number two, our R&D productivity have improved consistently over the last few years.

    第二,我們的研發生產力在過去幾年中不斷提高。

  • Let me exemplify with our Phase 2 success rates, have now been exceeding 40% for a number of years, well above benchmark.

    讓我以我們的第 2 階段成功率為例,多年來已經超過 40%,遠高於基準。

  • We estimate that [early] between 2018 and 2022, 25 to 30 approvals, from 2018 to year-to-date, we're already at 11.

    我們估計 [早期] 在 2018 年到 2022 年之間,有 25 到 30 個批准,從 2018 年到今年迄今,我們已經達到 11 個。

  • Within that approval wave, let me exemplify our focus on the 15-in-5 strategy to deliver blockbuster approvals.

    在批准浪潮中,讓我舉例說明我們對 15 合 5 戰略的關注,以提供重磅炸彈批准。

  • And within that cohort, as you have seen, we have had really good progress.

    正如您所見,在該隊列中,我們取得了非常好的進展。

  • And both Phase 2 and Phase 3 success rates are high and robust in also this most valuable compound.

    在這種最有價值的化合物中,第 2 階段和第 3 階段的成功率都很高且穩健。

  • Now I wanted to conclude and give you more of near-term opportunities for our pipeline.

    現在我想總結一下,並為您提供更多我們管道的近期機會。

  • So between now and 2020, you may want to remember the metrics, 15 plus 10 plus 5 plus 5. 15 relates to 15 POC readouts, up to 15 POC readouts; 10 to -- 10 Phase 3 starts; and then 5 for 5 Phase 3 readout and 5 key approvals.

    所以從現在到 2020 年,你可能要記住指標,15 加 10 加 5 加 5。15 涉及 15 個 POC 讀數,最多 15 個 POC 讀數; 10 至 -- 10 第 3 階段開始;然後是 5 個 5 個第 3 階段讀數和 5 個關鍵批准。

  • Let me give you a few examples on the POCs that you can keep an eye on.

    讓我給你舉幾個你可以關注的 POC 的例子。

  • We have 5 different POC -- up to 5 different POC readouts in our JAK franchise, including indications across topical -- atopic dermatitis, psoriasis, vitiligo and also psoriatic arthritis for an oral drug.

    我們有 5 種不同的 POC——在我們的 JAK 特許經營中有多達 5 種不同的 POC 讀數,包括局部適應症——口服藥物的特應性皮炎、牛皮癬、白斑和牛皮癬關節炎。

  • We have a strong momentum in our gene therapy platform.

    我們的基因治療平台勢頭強勁。

  • Albert mentioned in his introduction our factor-18 therapy where we are expecting soon a POC readout and have started to enroll for baseline characteristics in Phase 3.

    Albert 在他的介紹中提到了我們的 factor-18 療法,我們預計很快就會有 POC 讀數,並已開始登記第 3 階段的基線特徵。

  • We are progressing well with our DMD gene therapy, and we have reached proof of concept for our tissue factor pathway inhibitor monoclonal antibody.

    我們的 DMD 基因療法進展順利,我們已經完成了組織因子通路抑製劑單克隆抗體的概念驗證。

  • We're also going to strengthen our hemophilia and the Phase 3 plans are underway.

    我們還將加強我們的血友病治療,第三階段計劃正在進行中。

  • In Internal Medicine, I want to punctuate the angiopoietin-L3 deal pending close that we expect to have a POC readout early next year.

    在內科方面,我想強調一下即將結束的血管生成素-L3 交易,我們預計明年初會有 POC 讀數。

  • Our vaccine franchise also has a number of intriguing data sets to be shared.

    我們的疫苗專營權還有許多有趣的數據集可供分享。

  • Obviously, the P&G pediatric (inaudible) RSV maternal Phase 2 data next year followed by Phase 3 start pending data.

    顯然,明年 P&G 兒科(聽不清)RSV 母體 2 期數據緊隨其後的是 3 期開始待定數據。

  • And also, in our meningococcal pentavalent vaccine, we have actually reached very promising Phase 2 readout and are reviewing them to be shared for a potential Phase 3 start.

    而且,在我們的腦膜炎球菌五價疫苗中,我們實際上已經達到了非常有希望的第 2 階段讀數,並且正在審查它們以便共享以用於可能的第 3 階段開始。

  • Finally, in our Oncology franchise, we have the readout next year expected for our ENCORE BRAF/MEK fast line.

    最後,在我們的腫瘤專營權中,我們預計明年將對我們的 ENCORE BRAF / MEK 快速生產線進行讀數。

  • We have data coming from our next-generation CDKs and from a HER2 breast cancer ADC.

    我們的數據來自我們的下一代 CDK 和 HER2 乳腺癌 ADC。

  • So as you can see, I exemplified some out of the many POC readouts coming from now to next year and just punctuate that, of course, the late-stage pipeline to which you are more familiar with, major interesting things in 2020.

    正如你所看到的,我舉例說明了從現在到明年的許多 POC 讀數中的一些,當然,你更熟悉的後期管道,以及 2020 年的主要有趣事情。

  • High on everyone's agenda is the Ibrance early breast cancer, which we strongly look forward to, and I feel encouraged and optimistic about the Xeljanz, ankylosing spondylitis, JAK1 in the comparator atopic dermatitis studies that is the final data set for them, moving to potential submission.

    每個人議程上的重中之重是 Ibrance 早期乳腺癌,我們非常期待,我對特應性皮炎對照研究中的 Xeljanz、強直性脊柱炎、JAK1 感到鼓舞和樂觀,這是他們的最終數據集,正在向潛在的方向發展提交。

  • And of course, the P&G adult.

    當然,還有 P&G 成人。

  • And I'm sorry for -- it's somewhat lengthy, but it actually reflected the many exciting things to happen from now to end of 2020.

    很抱歉——它有點冗長,但它實際上反映了從現在到 2020 年底將發生的許多激動人心的事情。

  • Operator

    Operator

  • Your next question comes from Umer Raffat from Evercore.

    你的下一個問題來自 Evercore 的 Umer Rafat。

  • Umer Raffat - Senior MD & Senior Analyst of Equity Research

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I want to touch upon 3 things today, if I may.

    如果可以的話,我今天想談三件事。

  • First, Albert, there's been a lot of investor questions on whether Pfizer could potentially be interested in M&A to recover the EPS dilution because of Upjohn.

    首先,Albert,有很多投資者質疑輝瑞是否有可能對併購感興趣,以恢復因 Upjohn 而導致的 EPS 稀釋。

  • I just wanted to ask where you shake out on that, the first one.

    我只是想問一下,第一個,你在哪裡動搖了。

  • Secondly, on Upjohn, I noticed there was a S-4 filed yesterday where Pfizer's internal forecast was that Upjohn stays at $7.8 billion to $8 billion post 2020, even though there would have been a Lyrica patent expiry worth $800 million in Japan and even though China, 4 plus 7, would have intensified.

    其次,關於 Upjohn,我注意到昨天提交了一份 S-4,其中輝瑞公司的內部預測是 Upjohn 在 2020 年後保持在 78 億至 80 億美元,儘管 Lyrica 專利在日本到期時價值 8 億美元,儘管中國,4 加 7,會加強。

  • So my question is what's driving this potential $1.5 billion to $2 billion worth of revenue shortfall to keep Upjohn stable at close to $8 billion post 2020?

    所以我的問題是,是什麼導致了價值 15 億至 20 億美元的潛在收入缺口,以使 Upjohn 在 2020 年後穩定在接近 80 億美元的水平?

  • And finally, on tafamidis.

    最後,關於 tafamidis。

  • It's very encouraging to see you're already at 4,800 patients.

    看到你們已經有 4,800 名患者,這非常令人鼓舞。

  • And my question is, is it inconceivable that Pfizer could hit more than 40,000 patients diagnosed at peak?

    我的問題是,輝瑞公司在高峰期能感染超過 40,000 名確診患者是不是不可思議?

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Excellent questions, Umer.

    很好的問題,烏默爾。

  • So let me start with the M&A.

    那麼讓我從併購開始。

  • Frank can cover the Upjohn forecast.

    Frank 可以涵蓋 Upjohn 的預測。

  • And then of course, Angela will speak about tafamidis.

    當然,Angela 會談到 tafamidis。

  • On the M&A strategy, look, since the July of 2018, when I -- as Chief Operating Officer of that time, I articulated the strategy going forward on several items including M&A strategy.

    關於併購戰略,自 2018 年 7 月以來,作為當時的首席運營官,我闡述了包括併購戰略在內的幾個項目的未來戰略。

  • We are very consistent.

    我們非常一致。

  • Right now we are poised for organic growth.

    現在我們正準備實現有機增長。

  • Our organic growth, we forecast to be, on a 5 years CAGR, 6%.

    我們預測,我們的有機增長 5 年復合年增長率為 6%。

  • I know the analysts' expectation is even higher.

    我知道分析師的期望更高。

  • This number, even this 6%, compared to the analyst expectations likely will position -- it's not likely, it's positioning us compared to the data and our peer set, let's say, the top 10 to 15 companies in the industry, it'll be the second largest in terms -- the second fastest-growing company in the next 5 years with a 6% in terms of rate.

    這個數字,即使是這個 6%,與分析師的預期相比可能會定位——這不太可能,它是在與數據和我們的同行相比定位我們,比方說,行業前 10 到 15 家公司,它會在未來 5 年內成為第二大增長最快的公司,增長率為 6%。

  • And actually, the largest in terms of producing growth dollars because we are going to -- of course, of our size, of course.

    實際上,就產生增長美元而言,這是最大的,因為我們將——當然,我們的規模,當然。

  • So any efforts that we're going to do, I'm not going to jeopardize that.

    因此,我們將要做的任何努力,我都不會危及它。

  • So we are not -- the name of the game for us, I have said it many times, it is top line growth.

    所以我們不是——我們的遊戲名稱,我已經說過很多次了,這是頂線增長。

  • And M&A of scale, they have the tendency.

    而規模併購,他們有趨勢。

  • One, very difficult to find someone that will not be accretive given that we are the second fastest in our growth.

    第一,很難找到不會增值的人,因為我們是我們增長第二快的人。

  • And secondly, it is very destructive operationally.

    其次,它在操作上非常具有破壞性。

  • And we can always do a large M&A, but we have a very clear window of opportunity now to get it right, with our pipeline, to get it right with our launches.

    我們總是可以進行大規模的併購,但我們現在有一個非常明確的機會之窗,可以通過我們的管道,通過我們的發布來實現它。

  • As you can see, we are doing very well.

    如您所見,我們做得很好。

  • I don't want to put that at risk.

    我不想把它置於危險之中。

  • Our business development strategy will continue to be bolt-on that will have a focus on R&D.

    我們的業務發展戰略將繼續以研發為重點。

  • And when I speak about R&D, again, as I said before, I want to be very clear.

    當我再次談到研發時,正如我之前所說,我想說得非常清楚。

  • We are looking for Phase 2 assets, ready Phase 2, ready Phase 3 assets that -- like the ones that we did in the last four business development activities that will provide revenues at the post -26, -27 period when we start feeling again some of the LOEs.

    我們正在尋找第 2 階段資產、準備好的第 2 階段、準備好的第 3 階段資產——就像我們在過去四次業務發展活動中所做的那樣,這些資產將在 -26、-27 年後我們再次開始感覺時提供收入一些 LOE。

  • And we want to make sure that the 6% growth is sustainable over the decade, the whole decade rather than only for the first 6, 7 years of this decade.

    我們希望確保 6% 的增長在十年內是可持續的,整個十年,而不是僅僅在這十年的前 6、7 年。

  • So this is our strategy, and we are not looking for a large M&A right now.

    所以這是我們的戰略,我們現在不尋求大規模併購。

  • And with that, I will move to Frank to speak a little bit about the Upjohn projections and what we had in our Board presentation, which I think is pretty much in line with what we gave as guidance for next year.

    說到這裡,我將請 Frank 談談 Upjohn 的預測以及我們在董事會介紹中的內容,我認為這與我們給出的明年指導非常一致。

  • 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。

  • So for Upjohn, the 2020 revenue number that we put out there was $7.5 billion to $8 billion.

    因此,對於 Upjohn,我們公佈的 2020 年收入數字為 75 億至 80 億美元。

  • By the way, that number reflected the Lyrica LOE and it reflected the China VBP.

    順便說一句,這個數字反映了 Lyrica LOE,它反映了中國 VBP。

  • In fact, we anticipated the expansion of the China VBP in that number in terms of expansion going from 11 cities, to all provinces, 50% share to 70% share, that, that range anticipated the impact of VBP in China.

    事實上,我們預計中國 VBP 的數量會從 11 個城市擴展到所有省份,50% 到 70% 的份額,這個範圍預示了 VBP 在中國的影響。

  • So a couple of comments on how do we get to the rhythm of the numbers that you alluded to.

    因此,關於我們如何達到您提到的數字節奏的一些評論。

  • So first, think about this quarter.

    所以首先,想想這個季度。

  • Upjohn in China this quarter-to-quarter grew 2%.

    Upjohn 在中國本季度環比增長 2%。

  • How did it grow 2%?

    它是如何增長2%的?

  • It basically was able to mitigate the impact of the procurement program with geographic expansion within the country.

    它基本上能夠減輕採購計劃對國內地域擴張的影響。

  • We believe that that's an opportunity that continues on a going-forward basis.

    我們相信,這是一個繼續向前發展的機會。

  • We also believe that there's opportunities for that business in Emerging Markets outside of China and continuing opportunities for that business and the rest of the world, given the breadth of the portfolio is going to have, and quite frankly, the pipeline that the new company has on a going-forward basis.

    我們還認為,鑑於投資組合的廣度,而且坦率地說,新公司擁有的管道,我們還認為該業務在中國以外的新興市場存在機會,並且該業務和世界其他地區也有持續的機會在前進的基礎上。

  • So that's why you get to the numbers that were put into the S-4.

    所以這就是為什麼你得到 S-4 中的數字。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • And then, Angela, please, about tafamidis.

    然後,Angela,拜託,關於 tafamidis。

  • 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。

  • Certainly, we are extremely pleased with the diagnosis rates of ATTR-CM that we have seen to date, which is about 4% to 5%.

    當然,我們對迄今為止看到的 ATTR-CM 的診斷率感到非常滿意,大約是 4% 到 5%。

  • But even with that, it's important to remember that it is still a severely underdiagnosed disease, and we have a long way to go in terms of achieving what we believe our patients deserve.

    但即便如此,重要的是要記住,它仍然是一種嚴重未被診斷的疾病,要實現我們認為患者應得的目標,我們還有很長的路要走。

  • There are 2 aspects of this diagnosis.

    這個診斷有兩個方面。

  • The first is suspicion or suspecting the disease, and the second is the ability to detect the disease.

    第一是懷疑或懷疑疾病,第二是檢測疾病的能力。

  • As you know, because we've spoken about this over the last several quarters, we have been intensely focused on our educational efforts to help physicians suspect the disease.

    如您所知,因為我們在過去幾個季度一直在談論這個問題,所以我們一直專注於我們的教育工作,以幫助醫生懷疑這種疾病。

  • And this has been helped by the recently published red flag symptoms, which make it easier for physicians to see the possible clinical symptoms of ATTR-CM and helping them to drive suspicion of this disease.

    最近公佈的紅旗症狀對此有所幫助,這使醫生更容易看到 ATTR-CM 的可能臨床症狀,並幫助他們對這種疾病產生懷疑。

  • From there, we have been educating around the use of the scintigraphy as a noninvasive means to diagnose ATTR-CM.

    從那時起,我們一直在圍繞使用閃爍顯像作為診斷 ATTR-CM 的無創手段進行教育。

  • And we're pleased to see that to date, about 90% of our diagnosis is now being driven through scintigraphy.

    我們很高興地看到,到目前為止,我們大約 90% 的診斷現在都是通過閃爍掃描來驅動的。

  • Scintigraphy, as you know, is a well-established imaging technique, and it's widely available across the U.S. in cardiology practices.

    如您所知,閃爍掃描術是一種成熟的成像技術,在美國的心髒病學實踐中廣泛使用。

  • Actually, we estimate about 15,000 of these diseases are available in cardiology practices throughout the country.

    實際上,我們估計全國心髒病學實踐中大約有 15,000 種此類疾病。

  • And we're seeing then this willingness and the readiness of physicians to adopt ATTR-CM diagnosis through this mechanism.

    然後我們看到了醫生通過這種機制採用 ATTR-CM 診斷的意願和準備。

  • I know that benchmarks that we have quoted in the past show that a diagnosis rate of about 30% to 50% is what most rare diseases have achieved up until now, and that is what drove our peak estimate.

    我知道我們過去引用的基準表明,迄今為止大多數罕見病的診斷率約為 30% 至 50%,這也是我們做出最高估計的原因。

  • However, we are learning a tremendous amount every single day about this particular disease about what it takes to diagnose it.

    然而,我們每天都在學習大量關於這種特殊疾病的知識,了解如何診斷它。

  • And certainly, we are focused on making sure that we can do better than that for our patients.

    當然,我們專注於確保我們能為患者做得更好。

  • Operator

    Operator

  • Your next question comes from David Risinger from Morgan Stanley.

    你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

  • I have 2 questions.

    我有兩個問題。

  • First, could you just update us on the timing of the Ibrance adjuvant interim efficacy look?

    首先,您能否向我們更新 Ibrance 輔助中期療效觀察的時間?

  • And second, I was hoping you could speak to the gross margin upside in the quarter in a little bit more detail and comment on the sustainability of strong gross margins.

    其次,我希望你能更詳細地談談本季度毛利率的上升空間,並對強勁毛利率的可持續性發表評論。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Thank you.

    謝謝。

  • Very interesting questions, David.

    非常有趣的問題,大衛。

  • I think, again, Mikael can provide an update on the timing of Ibrance.

    我認為,Mikael 可以提供有關 Ibrance 時間的最新信息。

  • And of course, for margins, the master of margins improvements, Mr. Frank D'Amelio.

    當然,對於利潤率,提高利潤率的大師 Frank D'Amelio 先生。

  • Mikael?

    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。

  • As -- we tend in general not to be specific about interim analysis in any programs.

    因為 - 我們一般傾向於不具體說明任何程序中的中期分析。

  • We expect the program to run to completion in 2020.

    我們預計該計劃將在 2020 年完成。

  • There is an interim analysis a little bit earlier in 2020, but, most likely, it will run to completion.

    在 2020 年早些時候進行了一次中期分析,但很可能會完成。

  • And we remain optimistic about the outcome of the study based on Ibrance's very strong performance, more recently even supported by real-world evidence data that was very favorable towards different aspects of progression-free survival and also robust on overall survival actually having hazard ratio of less than 0.6, which probably is the strongest hazard ratio provided so far.

    我們仍然對基於 Ibrance 非常強勁表現的研究結果持樂觀態度,最近甚至得到了真實世界證據數據的支持,這些數據對無進展生存的不同方面非常有利,並且對總體生存率也很穩健,實際上風險比為小於 0.6,這可能是迄今為止提供的最強風險比。

  • And we will update that hazard ratio as the study matures.

    隨著研究的成熟,我們將更新該風險比。

  • Thank you very much.

    非常感謝。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Thank you, Michael.

    謝謝你,邁克爾。

  • Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations

    Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations

  • So Dave, I'll answer the gross margin question.

    所以戴夫,我會回答毛利率問題。

  • I think I'll also just add in even though you didn't ask a little bit about operating margins, too.

    我想我也會加入,即使你也沒有問過一點關於營業利潤率的問題。

  • So on gross margins, let's do it based on cost of sales.

    所以關於毛利率,讓我們根據銷售成本來做。

  • If you look at our cost of sales year-over-year, Q3 2018, 20.1%; Q3 2019, 19.4%.

    如果你看看我們的銷售成本同比,2018 年第三季度,20.1%; 2019 年第三季度,19.4%。

  • So directionally correct, right?

    所以方向正確,對吧?

  • Down on a year-over-year basis.

    同比下降。

  • What drove the improvement?

    是什麼推動了改進?

  • Really a couple of things.

    真的有幾件事。

  • One is some cost improvements that we were able to implement in our global supply chain organization.

    一是我們能夠在全球供應鏈組織中實施的一些成本改進。

  • Obviously, our manufacturing plants and the like.

    顯然,我們的製造工廠之類的。

  • And then secondly, we have some very favorable product mix, right?

    其次,我們有一些非常有利的產品組合,對吧?

  • If you look at where our revenue growth was, alliance revenues were up 18% year-over-year.

    如果你看看我們的收入增長情況,聯盟收入同比增長 18%。

  • Ibrance grew.

    伊布拉斯長大了。

  • So -- and then VYNDAQEL.

    所以——然後是 VYNDAQEL。

  • So we had some very favorable product mix.

    所以我們有一些非常有利的產品組合。

  • If you look at our operating margin for the quarter, high 30s, approximately 30%.

    如果你看一下我們本季度的營業利潤率,高達 30 多歲,大約 30%。

  • So if you look at the trending and then you think about going forward, one key on that operating margin rhythm will be the revenue growth.

    因此,如果您查看趨勢然後考慮未來發展,那麼營業利潤率節奏的一個關鍵將是收入增長。

  • So obviously, we're saying now that we think 6% operational revenue growth going forward, that will clearly help our operating margins on a going-forward basis relative to what we have said back in July because we'll leverage that to the bottom line.

    所以很明顯,我們現在說我們認為未來 6% 的營業收入增長,相對於我們在 7 月份所說的,這顯然將有助於我們未來的營業利潤率,因為我們將利用它來達到底部線。

  • And so I mentioned earlier, clearly, our intent is to improve upon the numbers that we provided previously that we're cautious, appropriately cautious back in July.

    所以我之前提到過,很明顯,我們的目的是改進我們之前提供的數字,我們在 7 月份保持謹慎,適當謹慎。

  • So net-net, we think we can improve upon the numbers we provided, and we'll give you all an update on that when we give our 2020 guidance.

    因此,net-net,我們認為我們可以改進我們提供的數字,我們會在我們提供 2020 年指導時向大家提供最新情況。

  • Operator

    Operator

  • Your next question comes from Tim Anderson from Wolfe Research.

    您的下一個問題來自 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。

  • On your revenue guidance of a 5-year CAGR of 6%, consensus is not at that level, and I'm wondering if there's any big areas that jump out at you specifically as being mismodeled by the analyst community in as much as you've looked at that sort of thing.

    關於你的 5 年復合年增長率為 6% 的收入指導,共識並未達到那個水平,我想知道是否有任何大的領域特別像你一樣被分析師社區誤導了我看過那種東西。

  • And then on abrocitinib, your JAK inhibitor, you're running a trial called JADE compare head-to-head versus Dupixent, always bold to take on a product head-to-head.

    然後在你的 JAK 抑製劑 abrocitinib 上,你正在運行一個名為 JADE 的試驗,將頭對頭與 Dupixent 進行比較,總是大膽地面對一個產品。

  • It looks like this trial should be reading out in December of this year, so coming up.

    看樣子這個審理應該在今年12月份宣讀,所以就來了。

  • I'm wondering, what we should realistically expect from that, both in terms of efficacy and safety?

    我想知道,在有效性和安全性方面,我們應該從中實際期待什麼?

  • It seems that at least on safety and tolerability, it almost can't look as good as Dupi because it's a small molecule JAK inhibitor, but maybe you can kind of tell us what you expect that trial will show.

    似乎至少在安全性和耐受性方面,它看起來幾乎不如 Dupi,因為它是一種小分子 JAK 抑製劑,但也許您可以告訴我們您期望該試驗會顯示什麼。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Yes.

    是的。

  • I think the -- again, the R&D question, I think, will go to Mikael.

    我認為 - 我認為,研發問題將交給 Mikael。

  • Just a brief comment, but, look, we speak about our numbers, right?

    只是一個簡短的評論,但是,看,我們談論我們的數字,對嗎?

  • And the 6% that we're providing for our numbers, we are very, very comfortable with this number.

    我們為我們的數字提供的 6%,我們對這個數字非常非常滿意。

  • We want to make sure that we say what we do and we do what we say.

    我們要確保言出必行,言出必行。

  • So I don't want to jeopardize that.

    所以我不想危及這一點。

  • So I'm giving numbers that we feel very comfortable that we will achieve.

    所以我給出了我們感到非常滿意的數字,我們將實現。

  • I have seen a lot of reports of analysts that they are having higher numbers than that.

    我看過很多分析師的報告,他們的數字比這個數字更高。

  • That's why I referred to that.

    這就是我提到它的原因。

  • I'm going to check what is the consensus on that.

    我將檢查對此達成的共識是什麼。

  • But as I said, I don't want to comment on other people's.

    但正如我所說,我不想評論別人的。

  • You are doing your job and we are doing our job.

    你在做你的工作,我們在做我們的工作。

  • We feel very comfortable on the 6%.

    我們對 6% 感到非常滿意。

  • Mikael?

    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。

  • Thank you very much for shedding light on the compare study.

    非常感謝您闡明比較研究。

  • So we are very excited about that study as it concludes our potential filing material, including then aggregate safety data.

    因此,我們對這項研究感到非常興奮,因為它總結了我們可能的備案材料,包括匯總的安全數據。

  • It is a head-to-head against Dupixent -- dupilumab Dupixent, and we felt that it's an important trial in the sense we expect both drugs to show tolerability and safety that are favorable.

    這是與 Dupixent 的正面交鋒——dupilumab Dupixent,我們認為這是一項重要的試驗,因為我們希望這兩種藥物都能顯示出良好的耐受性和安全性。

  • We expect abrocitinib, based on current historical comparison, to do very well on efficacy on clearance of skin.

    根據當前的歷史比較,我們預計 abrocitinib 在皮膚清除方面的療效非常好。

  • And we have specifically an endpoint on itch relief, pruritus reduction, which is one of the critical, most patient-friendly, centered endpoints.

    我們在緩解瘙癢、減少瘙癢方面有一個明確的終點,這是關鍵的、對患者最友好的、以中心為中心的終點之一。

  • And we expect, and I believe that abrocitinib would outperform Dupixent in a very clinical, meaningful manner as it has a strong, fast onset.

    我們預計,我相信 abrocitinib 將以非常臨床、有意義的方式優於 Dupixent,因為它具有強大、快速的起效。

  • And data available, although not head-to-head, showed that the JAK1 class not just performed better clinically so far, and head-to-head is the reason why we wanted to document that hypothesis, but there is also science behind it.

    可用的數據雖然不是面對面的,但表明 JAK1 類到目前為止不僅在臨床上表現更好,而且面對面是我們想要記錄該假設的原因,但它背後也有科學依據。

  • It inhibits the Interleukin-31 that is a major itch mediator, which is not covered by Dupixent.

    它抑制 Interleukin-31,它是一種主要的瘙癢介質,Dupixent 未涵蓋。

  • So I hope that gave you some insight into our integers.

    所以我希望這能讓你對我們的整數有一些了解。

  • Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations

    Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations

  • And Tim, it's Frank.

    蒂姆,是弗蘭克。

  • I just wanted to add to what Albert said.

    我只是想補充 Albert 所說的話。

  • Remember, when the new company is formed between our Upjohn business and Mylan, RemainCo, our new Pfizer, is our Pfizer Biopharma business.

    請記住,當我們的 Upjohn 業務和 Mylan 之間成立新公司時,我們的新輝瑞 RemainCo 是我們的輝瑞生物製藥業務。

  • Our Biopharma business this quarter grew 9%., the last couple of quarters grew 6%, 7%.

    我們的生物製藥業務本季度增長了 9%,過去幾個季度增長了 6%、7%。

  • So that approximately 6% that Albert gave, we've been printing now literally for the last few quarters.

    因此,Albert 提供的大約 6%,我們在過去幾個季度一直在打印。

  • And remember, when Newco was formed, new Pfizer, RemainCo keeps all of the growth drivers that we currently talked about on this call.

    請記住,當 Newco 成立時,新的輝瑞,RemainCo 保留了我們目前在這次電話會議上談到的所有增長動力。

  • So that portfolio, the momentum of that portfolio carries into the new Pfizer.

    因此,該投資組合,該投資組合的勢頭將帶入新的輝瑞。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Very good points, Frank.

    很好,弗蘭克。

  • Operator

    Operator

  • Your next question comes from Steve Scala from Cowen.

    你的下一個問題來自 Cowen 的 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • I have a couple.

    我有一對。

  • First, for Mikael, the press release says that after 3 doses in infants, the safety of 20-valent pneumococcal vaccine is similar to Prevnar 13, but you don't say the efficacy is similar after 3 doses in terms of immune response due to 13 valents that they have in common.

    首先,對於Mikael,新聞稿說嬰兒接種3劑後,20價肺炎球菌疫苗的安全性與Prevnar 13相似,但在免疫反應方面你沒有說3劑後功效相似,因為他們有 13 個共同點。

  • Can you comment on that point and the response to the additional 7 valents?

    你能評論一下這一點以及對額外 7 價的回應嗎?

  • I know Prevnar 13 is a 4-dose regimen, but you must have data after 3 doses.

    我知道 Prevnar 13 是 4 劑方案,但您必須有 3 劑後的數據。

  • So that's the first question.

    這是第一個問題。

  • Second question for Frank.

    弗蘭克的第二個問題。

  • Should something draconian come out of Washington that overnight cut revenue by 10%, a 20% reduction in operating expenses would appear required to protect the bottom line.

    如果華盛頓出台嚴厲措施,一夜之間將收入削減 10%,則似乎需要將運營支出削減 20% 以保護底線。

  • Could a 20% reduction in operating expenses be delivered?

    能否減少 20% 的運營費用?

  • And if yes, would it take 6 months, 12 months or would it take much longer?

    如果是,需要 6 個月、12 個月還是更長的時間?

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Mikael?

    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。

  • We shared data on 3 immunizations.

    我們共享了 3 種免疫接種的數據。

  • And it was a descriptive study, not powered for efficacy, but I -- my take at this was, as in the press release, we had very robust rise in immune titer against all 20 serotypes.

    這是一項描述性研究,沒有效力,但我 - 我對此的看法是,正如在新聞稿中那樣,我們對所有 20 种血清型的免疫滴度都有非常強勁的上升。

  • And at this stage, they look very similar to the PCV13 when you look at totality of data.

    在這個階段,當您查看全部數據時,它們看起來與 PCV13 非常相似。

  • And the immune titers also are supplemented by functional antibody responses that we're now obtaining that, again, look very robust for the PCV20 across all serotypes.

    免疫滴度也得到了我們現在獲得的功能性抗體反應的補充,對於所有血清型的 PCV20 來說,這再次看起來非常強大。

  • I wanted also to say that increasingly available epidemiology data strengthened the notion that the PCV20 has a very broad coverage, far exceeding PCV15 developed by a competitor, whether you look at the infant population, the adult population, U.S. or European major countries and whether you look at IPD and CAP.

    我還想說,越來越多的流行病學數據強化了 PCV20 覆蓋範圍非常廣泛的觀念,遠遠超過了競爭對手開發的 PCV15,無論是嬰兒人口、成人人口、美國還是歐洲主要國家,也無論您是看看 IPD 和 CAP。

  • So we're very pleased with emerging data and increased insights into epidemiology that indicates this vaccine has the potential to provide the broadest ever coverage for a pneumococcal disease.

    因此,我們對新出現的數據和對流行病學的深入了解感到非常高興,這些數據表明這種疫苗有可能為肺炎球菌疾病提供有史以來最廣泛的覆蓋範圍。

  • Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations

    Frank A. D'Amelio - CFO & EVP of Global Supply & Business Operations

  • And then, Steve, if there was some draconian action that resulted in a 10% impact on our revenue, which is a big number, then clearly we would have to revisit our cost structure.

    然後,史蒂夫,如果有一些嚴厲的行動對我們的收入造成 10% 的影響,這是一個很大的數字,那麼顯然我們將不得不重新審視我們的成本結構。

  • I mean, how could we not?

    我的意思是,我們怎麼能不呢?

  • In terms of how much we could do it, how quickly we would do it, quite frankly, we'd have to work our way through that.

    坦率地說,就我們能做到多少、我們能多快做到這一點而言,我們必須努力解決這個問題。

  • But the short answer is we would clearly review our cost structure, every element of the cost structure, by the way, which we do all the time anyway, and then see what we have to do to deal with -- quite frankly, what the model is -- what the business model is going forward.

    但簡短的回答是,我們會清楚地審查我們的成本結構,成本結構的每個元素,順便說一句,我們一直在做,然後看看我們必須做些什麼來處理——坦率地說,什麼模型是——未來的商業模式是什麼。

  • A 10% decline in our revenues is a change in our business model.

    我們的收入下降 10% 是我們商業模式的改變。

  • And then we'd have to obviously look at that in terms of how we run our business on a going-forward basis.

    然後我們顯然必須從我們如何在未來的基礎上經營我們的業務的角度來看待這一點。

  • Operator

    Operator

  • Your next question comes from Navin Jacob from UBS.

    你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

  • Two questions, if I may.

    兩個問題,如果可以的話。

  • Number one, on Hospira, as you have stabilized that business and the manufacturing capabilities there, wondering if you could help us understand, to what extent there have been "lost revenues" over the last 2 years that would -- you may have been able to have if Hospira had been at full capacity?

    第一,關於 Hospira,因為你已經穩定了那裡的業務和製造能力,想知道你是否可以幫助我們了解過去兩年中在多大程度上“收入損失”——你可能已經能夠如果 Hospira 已滿負荷運行?

  • And basically, what I'm asking is, how much do you think you can recover going forward for Hospira?

    基本上,我要問的是,您認為您可以為 Hospira 恢復多少?

  • And how quickly could that growth be achieved?

    這種增長能以多快的速度實現?

  • And then on the C. difficile vaccine, I think the Phase 3 was supposed to read out in 2020, but I think you just went through an interim analysis in the DSMB or the Monitoring Board suggested to expand that study.

    然後關於艱難梭菌疫苗,我認為第 3 階段應該在 2020 年宣讀,但我認為你剛剛在 DSMB 中進行了中期分析,或者監測委員會建議擴大該研究。

  • Wondering when the readout for that Phase 3 will be now.

    想知道第 3 階段的讀數現在是什麼時候。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Right.

    正確的。

  • I think Angela can answer the Hospira question.

    我認為 Angela 可以回答 Hospira 的問題。

  • Just to say something, for us, the manufacturing issues and supply issues for Hospira created, I would say, a loss of trust with our customer.

    我想說的是,對我們來說,Hospira 的製造問題和供應問題造成了對我們客戶的信任喪失。

  • This is, for me, the most important, okay?

    對我來說,這是最重要的,好嗎?

  • And that's why we took it very seriously.

    這就是我們非常重視它的原因。

  • And we were very transparent with them, and we created also a Hospital business unit because this is mostly hospital products.

    我們對他們非常透明,我們還創建了一個醫院業務部門,因為這主要是醫院產品。

  • So that can be very customer-focused only on the hospitals.

    這樣一來,醫院就可以非常以客戶為中心。

  • So that we can make sure that we have the relations that we had before built and make them very strong.

    這樣我們就可以確保我們擁有之前建立的關係,並使它們非常牢固。

  • And I have to say that we were very successful on that.

    我不得不說我們在這方面非常成功。

  • And what the customers appreciated the most was the transparency.

    客戶最欣賞的是透明度。

  • Obviously, there is business that we lost, and we hope that we will recover most of it.

    顯然,我們失去了一些業務,我們希望我們能恢復其中的大部分。

  • Angela, what do you think?

    安吉拉,你怎麼看?

  • Angela Hwang - Group President of Biopharmaceuticals Group

    Angela Hwang - Group President of Biopharmaceuticals Group

  • Sure.

    當然。

  • I think the way I would think about the future growth of the Hospital business unit and even Hospira would be in the following way.

    我認為我對醫院業務部門甚至 Hospira 的未來增長的思考方式如下。

  • I think there's a portion of the revenue that was lost as a result of the supply issues that we would recover.

    我認為有一部分收入是由於我們將恢復的供應問題而損失的。

  • There is a portion that we wouldn't recover, but that isn't -- I guess that's not the only source of growth.

    有一部分我們無法恢復,但事實並非如此——我想這不是唯一的增長來源。

  • I think the way to think about growth also is what we're doing to continue to diversify that portfolio and to bring in new launches.

    我認為考慮增長的方式也是我們正在做的事情,以繼續使該產品組合多樣化並推出新產品。

  • You heard Frank talk about PANZYGA as one of those, and in our pipeline and in our portfolio today, our continuous launches both from a presentation and a device perspective as well as from a molecule perspective.

    你聽說 Frank 談到 PANZYGA 就是其中之一,在我們的管道和我們今天的產品組合中,我們從演示和設備的角度以及從分子的角度不斷推出。

  • I think the other element of the Hospital business unit that we also need to consider is the strong anti-infective portfolio that is part of that business unit.

    我認為我們還需要考慮的醫院業務部門的另一個要素是作為該業務部門一部分的強大的抗感染產品組合。

  • Those are sterile injectables.

    那些是無菌注射劑。

  • And in that unit or in that portion of the business are a number of new launches that began a couple of years ago and are now launching globally.

    在該部門或業務的那一部分,幾年前開始推出許多新產品,現在正在全球範圍內推出。

  • So that's how I would think about growth in that portfolio is that it's not dependent purely on the replacement or the regaining of business.

    因此,我認為該投資組合的增長並不完全取決於業務的更換或恢復。

  • A portion of it is, but much more of it is dependent on new ventures and new spaces that we're venturing into.

    其中一部分是,但更多取決於我們正在冒險進入的新企業和新空間。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Yes, Mikael.

    是的,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

  • On the C. diff, yes, we're pleased with the aspect that safety and tolerability was regarded as favorable at the interim analysis.

    在 C. diff 上,是的,我們很高興在中期分析中安全性和耐受性被認為是有利的。

  • And clearly, the fertility analysis indicated that the study should continue.

    顯然,生育力分析表明該研究應該繼續進行。

  • While we try to target high-risk patients for C. difficile infection, by looking at increased risk for contact with health care community or recent use of antibiotics, we are, of course, pioneers in this area of developing a vaccine for this urgent need for preventing what can be fatal C. diff infections.

    雖然我們試圖通過研究與醫療保健社區接觸或最近使用抗生素的風險增加來針對艱難梭菌感染的高風險患者,但我們當然是這一領域的先驅,為這一迫切需求開發疫苗用於預防可能致命的艱難梭菌感染。

  • So we'll use all our insights learned today to make sure that we can continue and expand enrollment to follow the advice from the monitoring committee to make sure we can conclude the study as soon as possible.

    因此,我們利用今天學到的所有見解來確保我們能夠繼續並擴大招募人數,以遵循監督委員會的建議,以確保我們能夠盡快完成研究。

  • And, of course, there's an urgency with 450,000 C. diff infections every year in U.S. and close to 30,000 of death, and we'll do everything possible to accelerate the readout of this study and get events.

    而且,當然,美國每年有 450,000 例艱難梭菌感染和近 30,000 例死亡的緊迫性,我們將盡一切可能加快這項研究的讀出並獲得事件。

  • We clearly do accumulate events, although somewhat slower than we initially hoped.

    我們顯然確實積累了事件,儘管比我們最初希望的要慢一些。

  • But rest assured that we will do everything we can to make sure the readout is coming as soon as possible, and we will later update you with more firm aspects of that.

    但請放心,我們將盡一切努力確保盡快獲得讀數,稍後我們會向您提供更確切的信息。

  • Operator

    Operator

  • Your next question comes from Andrew Baum from Citi.

    你的下一個問題來自花旗銀行的 Andrew Baum。

  • Andrew Simon Baum - Global Head of Healthcare Research and MD

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • Your portfolio is heavily exposed to high list price, heavy Part D exposed drugs.

    您的投資組合嚴重暴露於高標價、大量暴露於 D 部分的藥物。

  • I'm obviously thinking about Ibrance, Inlyta, Xtandi and so on and so forth.

    我顯然在考慮 Ibrance、Inlyta、Xtandi 等等。

  • You mentioned you welcomed the proposal to cap out-of-pocket spend under Medicare Part D, but within the same finance committee proposal, there is also an obligation for you to fund catastrophic coverage to the tune of 20%, an even larger contribution from the plan sponsor.

    你提到你歡迎在 Medicare D 部分下限制自付費用的提議,但在同一個財務委員會提議中,你還有義務為災難性保險提供資金,達到 20%,來自的更大貢獻計劃發起人。

  • So my question is, what is your comfort level with that part of the proposal?

    所以我的問題是,您對提案的這一部分感到滿意嗎?

  • And to what extent do you think, particularly in crowded classes like the CDK4/6s the obligation on the plan providers to fund catastrophic coverage is going to further increase price competition in the segment?

    您認為在多大程度上,尤其是在像 CDK4/6s 這樣擁擠的班級中,計劃提供者為災難性保險提供資金的義務將進一步加劇該細分市場的價格競爭?

  • And then the second question very quickly is, historically, Ian railed against some of your competitors, for basically holding Xeljanz into very treatment refractory settings, given exposition of their rebate power, I'm thinking particularly of Humira.

    然後很快第二個問題是,從歷史上看,伊恩抨擊你的一些競爭對手,因為基本上將 Xeljanz 置於非常難處理的環境中,考慮到他們的回扣能力,我特別想到 Humira。

  • What's your confidence level that you're going to be able to secure favorable market positions with JAKs given drugs like Dupixent are going to be generating significant rebates for the PBMs in the commercial book of business by the time you hit the market?

    考慮到像 Dupixent 這樣的藥物在您進入市場時將在商業業務簿中為 PBM 帶來可觀的回扣,您對能夠通過 JAK 獲得有利的市場地位的信心水平如何?

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Thank you very much.

    非常感謝。

  • Let me try to answer your question about the out-of-pocket and all these reforms in the Medicare that have been proposed, and then I will ask Angela to speak about Xeljanz.

    讓我試著回答你關於自付費用和所有這些已提議的醫療保險改革的問題,然後我會請安吉拉談談 Xeljanz。

  • When it comes to price reforms, there are things that we agree and there are things that we do not agree.

    談到價格改革,有些事情我們同意,有些事情我們不同意。

  • But I will tell you that we are fanatically in favor of reducing out-of-pocket costs to patients.

    但我會告訴你,我們狂熱地支持減少患者的自付費用。

  • Because right now, the fundamental issue that drives this polarization in the political environment around health care.

    因為現在,推動醫療保健政治環境兩極分化的根本問題。

  • It is a real problem.

    這是一個真正的問題。

  • And the problem is that the Americans are paying for their medicines.

    問題是美國人正在為他們的藥物買單。

  • Like if they are not insured, although they are having insurance, when they go to collect them from the counter of the pharmacy.

    就像他們沒有保險一樣,儘管他們有保險,但當他們去藥房櫃檯取藥時。

  • This is not happening with hospital.

    醫院不會發生這種情況。

  • This is not happening with diagnostics.

    診斷不會發生這種情況。

  • This is not happening with other medical interventions, at least to the degree that it's happening with medicines.

    其他醫療干預措施不會發生這種情況,至少在藥物方面不會發生這種情況。

  • And this is why the drug pricing is so high in the debate, although they represent only 10%, 12% of the total health care costs.

    這就是為什麼藥品定價在辯論中如此之高,儘管它們僅佔醫療保健總成本的 10%、12%。

  • So that needs to be addressed.

    所以這需要解決。

  • Now the way that the Senate, for example, is proposing to address it, or even worse to the House, they are going to increase the contribution of the pharmaceutical companies.

    例如,現在參議院提議解決這個問題的方式,或者更糟糕的是眾議院,他們將增加製藥公司的貢獻。

  • And of course, this will hurt, but this is the least of my problems overall because at least, what hurts us helps the patients.

    當然,這會造成傷害,但這是我所有問題中最少的,因為至少,傷害我們的東西可以幫助患者。

  • My issue with this bill, it is that a lot of other measures that they are suggesting that hurt us even more.

    我對這項法案的看法是,他們建議的許多其他措施對我們的傷害更大。

  • They are not moving the savings to the patients, which is the fundamental issue that, right now, society is dealing with.

    他們沒有將儲蓄轉移給患者,這是目前社會正在處理的根本問題。

  • And this is our efforts here.

    這是我們在這裡的努力。

  • I believe that it is to the benefit of the industry.

    我相信這對行業有利。

  • It is to the benefit of innovation.

    這有利於創新。

  • It is to the benefit of patients.

    這是為了患者的利益。

  • It is to the benefit of the health care system to reduce the cap, to reduce the out-of-pocket expenses either with rebate reform or, if that's not on the picture right now, by reducing the --by implementing a cap for out-of-pocket.

    降低上限對醫療保健系統有利,可以通過退稅改革減少自付費用,如果現在還沒有實現,則可以通過實施上限來減少自付費用口袋裡的。

  • It's of paramount importance even if we have to pay for it.

    這是最重要的,即使我們必須為此付出代價。

  • And Xeljanz, Angela?

    還有 Xeljanz,安吉拉?

  • Angela Hwang - Group President of Biopharmaceuticals Group

    Angela Hwang - Group President of Biopharmaceuticals Group

  • So it is true that when we look back, the Xeljanz access has been challenging through time.

    因此,當我們回顧過去時,Xeljanz 訪問確實隨著時間的推移而充滿挑戰。

  • But certainly, we, over the last several years, have worked hard with our payers as well as our PBMs as well as amassing, I think, some really strong scientific and patient experience and evidence behind Xeljanz that is creating momentum for this particular product.

    但可以肯定的是,在過去的幾年裡,我們一直在與我們的付款人以及我們的 PBM 一起努力工作,並且我認為,在 Xeljanz 背後積累了一些非常強大的科學和患者經驗和證據,這些經驗和證據正在為這個特定產品創造動力。

  • The I&I category generally is one that is the most heavily rebated, and I think that we have demonstrated our ability to be a real solution in this space of great unmet need.

    I&I 類別通常是回扣最多的類別,我認為我們已經證明我們有能力在這個需求未得到滿足的領域成為真正的解決方案。

  • And as evidence, just compared to last year this time, we now have 32 million more incremental lives in Medicare and commercial channels that have gained unrestricted access.

    作為證據,與去年相比,我們現在在醫療保險和商業渠道中獲得了不受限制的訪問,增加了 3200 萬的生命。

  • And specifically, in fact, just this past May, we gained an additional 8 million lives.

    具體來說,事實上,就在剛剛過去的五月,我們又增加了 800 萬人的生命。

  • So I think that this is sort of good evidence to show how we are working hand-in-hand with our payers as well as our PBMs to bring the totality of our data and our experience to bear, filling an area of great unmet need.

    所以我認為這是一個很好的證據,表明我們如何與我們的付款人以及我們的 PBM 攜手合作,以利用我們的全部數據和我們的經驗,填補一個巨大的未滿足需求的領域。

  • Operator

    Operator

  • Your next question comes from Terence Flynn from Goldman Sachs.

    你的下一個問題來自高盛的特倫斯弗林。

  • Terence C. Flynn - MD

    Terence C. Flynn - MD

  • Albert, you mentioned a few of your upcoming biosimilar launches.

    阿爾伯特,你提到了一些即將推出的生物仿製藥。

  • Just wondering if you can help frame for us the potential size of the opportunity as you think about the long term there, and maybe walk through some of the remaining hurdles in terms of establishing a robust biosimilar market in the U.S.?

    只是想知道您是否可以在您考慮那裡的長期時幫助我們確定機會的潛在規模,並可能在美國建立強大的生物仿製藥市場方面克服一些剩餘的障礙?

  • And then, Angela, just wondering, any more color you can provide on the Xtandi dynamics in terms of either share among the different segments or maybe mix of the prescriber base?

    然後,Angela,只是想知道,您可以在 Xtandi 動態方面提供更多顏色,無論是在不同細分市場之間的份額還是處方者基礎的混合?

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Let me speak a little bit about -- generally about biosimilars, and then I will ask Angela to answer the second question and also specifics of the biosimilars potential that we are going to launch.

    讓我談談——一般來說是關於生物仿製藥,然後我會請安吉拉回答第二個問題,以及我們將要推出的生物仿製藥潛力的細節。

  • I think in the U.S., unlike other countries, there is a problem with the system.

    我認為在美國,與其他國家不同,系統存在問題。

  • And the system is that there is -- the fundamental issue that there is this rebate trap.

    系統存在 - 存在這種回扣陷阱的根本問題。

  • But payers, although they do see the benefit of using the biosimilars solution that physicians would like to prescribe and that the FDA's saying that has similar efficacy and safety and it is much cheaper, although they want to do that, they are trapped and they cannot because they are going to lose the benefits or the rebates that the originator is offering.

    但是付款人,儘管他們確實看到了使用醫生願意開的生物仿製藥解決方案的好處,而且 FDA 的說法具有相似的療效和安全性,而且價格便宜得多,儘管他們想這樣做,但他們被困住了,他們不能因為他們將失去發起人提供的利益或回扣。

  • And I think, frankly, that unless we resolve this big issue, we will never be able to see tremendous progress on biosimilars.

    我認為,坦率地說,除非我們解決這個大問題,否則我們永遠無法看到生物仿製藥取得巨大進展。

  • So this is something, I think, that the political world is understanding.

    所以我認為,政治界正在理解這一點。

  • This is something that we are very vocal about it.

    這是我們非常直言不諱的事情。

  • This is something that we are discussing constantly with payers, who they want to move to new solutions, but they cannot.

    這是我們不斷與付款人討論的問題,他們希望他們轉向新的解決方案,但他們不能。

  • And I think that there is positive momentum on that, but still I repeat, to be able to see transformational change in the penetration of biosimilars, so the health care system can see real lives.

    我認為這方面有積極的勢頭,但我仍然重申,能夠看到生物仿製藥滲透的轉型變化,因此醫療保健系統可以看到真實的生活。

  • Significant savings can only happen if we find a solution to that.

    只有找到解決方案,才能節省大量資金。

  • We have also suggested other measures like the savings should be served by providers, et cetera, et cetera, but I think that's the fundamental one.

    我們還建議採取其他措施,例如儲蓄應由提供者等提供,但我認為這是最基本的措施。

  • Now all biosimilars are not the same because -- and not all markets are the same.

    現在所有的生物仿製藥都不一樣,因為——而且並不是所有的市場都是一樣的。

  • Whether you have closed systems like the Kaiser, for example, the penetration of biosimilars is very, very high because they can see the benefit of doing something like that.

    例如,無論您是否擁有像 Kaiser 這樣的封閉系統,生物仿製藥的滲透率都非常非常高,因為他們可以看到這樣做的好處。

  • But when you have intermediates being involved but then big rebates in play, it's very difficult for them to do.

    但是當你有中間人參與,然後大回扣在起作用時,他們很難做到。

  • And also, oncology is very different.

    而且,腫瘤學非常不同。

  • Also, biosimilars from, I&I biosimilars because the I&I, they are giving for very extensive period of time, so you need to switch.

    此外,來自 I&I 生物仿製藥的生物仿製藥,因為 I&I,它們提供了非常長的時間,所以你需要轉換。

  • New patients aren't coming very often.

    新病人不常來。

  • Oncology is very different because it's more limited the period that they are -- that therapists use.

    腫瘤學非常不同,因為治療師使用的時間更有限。

  • And then the patients are coming much more often.

    然後病人來得更頻繁了。

  • New patients are coming much more often in higher proportion.

    新患者的比例更高。

  • But, Angela, maybe you want to add into that, and then also provide an answer to the second question.

    但是,安吉拉,也許你想補充一下,然後也提供第二個問題的答案。

  • Angela Hwang - Group President of Biopharmaceuticals Group

    Angela Hwang - Group President of Biopharmaceuticals Group

  • Sure.

    當然。

  • I think Albert has said much of it, and maybe what I can add is the following.

    我認為 Albert 已經說了很多,也許我可以補充以下內容。

  • I think within the context of the fact that the U.S. dynamics are very different from the European dynamics, where you see a much greater adoption of biosimilars, what we have seen with our supportive care biosimilar, which is RETACRIT, is that we've seen some nice growth there.

    我認為,在美國動態與歐洲動態非常不同的背景下,您會看到生物仿製藥的採用率大大提高,我們在支持性護理生物仿製藥(RETACRIT)中看到的是我們已經看到那裡有一些不錯的增長。

  • Like to date, it has a 16% market share, which is the highest that we have seen of any biosimilar here in the U.S. And I think that, that tells us, and that's given us the opportunity to learn about what it will take to launch oncology biosimilars as well as what we can expect in this particular space.

    到目前為止,它擁有 16% 的市場份額,這是我們在美國看到的所有生物仿製藥中最高的。我認為,這告訴了我們,這讓我們有機會了解它需要什麼推出腫瘤生物仿製藥以及我們在這個特定領域的期望。

  • So I think with the 3 biosimilars coming within one after the other, December, January, February of end of this year, we look forward to driving the growth of this portfolio of biosimilars in an area of high unmet need for patients.

    因此,我認為隨著今年年底 12 月、1 月、2 月的 3 種生物仿製藥相繼上市,我們期待在患者需求未得到滿足的領域推動這一生物仿製藥組合的增長。

  • As it pertains to Xtandi, you do see a tremendous growth here this quarter.

    就 Xtandi 而言,本季度你確實看到了巨大的增長。

  • We had a great quarter growing 25% year-over-year.

    我們有一個很棒的季度,同比增長 25%。

  • And I think that this is evidence of the great confidence that our prescribers, both neurologists and medical oncologists, are having with Xtandi.

    我認為這證明了我們的開處方者,包括神經學家和內科腫瘤學家,對 Xtandi 充滿信心。

  • We have leading market share at 37% branded in a growing class.

    我們以 37% 的品牌在不斷增長的類別中佔據領先的市場份額。

  • And the class as well has been one that has grown 3 points from last quarter to this quarter.

    從上一季度到本季度,班級也增長了 3 分。

  • So when we look at our sources of patients for Xtandi, they come in 2 forms.

    因此,當我們查看 Xtandi 的患者來源時,他們有兩種形式。

  • First, it's the non-metastatic castrate-resistant prostate cancer, where we continue to see increases, both in total patients as well as new patient starts since the PROSPER approval.

    首先,它是非轉移性去勢抵抗性前列腺癌,自 PROSPER 批准以來,我們繼續看到患者總數和新患者開始增加。

  • And just as a measure of PROSPER, urologists are generally the prescribers in an earlier disease setting.

    正如 PROSPER 的衡量標準一樣,泌尿科醫生通常是早期疾病環境中的處方者。

  • And here, our urology prescribing is growing at 44%.

    在這裡,我們的泌尿科處方增長了 44%。

  • And so we're continuing to see the proportion of our business from PROSPER grow very positively.

    因此,我們繼續看到來自 PROSPER 的業務比例非常積極地增長。

  • Also to remember that these patients are earlier in terms of their course of disease and, therefore, have higher days of therapy.

    還要記住,這些患者的病程較早,因此需要更多的治療天數。

  • So this will drive the prescriptions and the revenues.

    因此,這將推動處方和收入。

  • In metastatic CRPC, castrate-resistant prostate cancer, which is still the majority of our business, our new patient share continues to increase there, too.

    在轉移性 CRPC 和去勢抵抗性前列腺癌中,這仍然是我們的主要業務,我們在那裡的新患者份額也在繼續增加。

  • And here, we not only have the #1 share of voice with oncologists, but our prescribing with oncology, medical oncology continues to grow significantly as well in this quarter at 21%.

    在這裡,我們不僅在腫瘤學家中擁有排名第一的話語權,而且我們在腫瘤學、醫學腫瘤學方面的處方在本季度也繼續顯著增長,達到 21%。

  • And so when you bring all of this together and you add into that the approval and/or the positive Phase 3 results we got from Ezimet and the submissions that we have for additional indications in both the non-metastatic, the hormone-sensitive setting as well as additional data from the EMBARK study, I think that what we have in Xtandi is a uniquely positioned NHT that is going to able to treat multiple indications in both hormone-sensitive as well as castrate-resistant prostate cancer.

    因此,當您將所有這些放在一起並添加我們從 Ezimet 獲得的批准和/或積極的 3 期結果以及我們提交的關於非轉移性、激素敏感環境的額外適應症的提交以及來自 EMBARK 研究的額外數據,我認為我們在 Xtandi 中擁有的是一種定位獨特的 NHT,它將能夠治療激素敏感和去勢抵抗性前列腺癌的多種適應症。

  • Operator

    Operator

  • Your next question comes from Louise Chen from Cantor Fitzgerald.

    你的下一個問題來自 Cantor Fitzgerald 的 Louise Chen。

  • Louise Alesandra Chen - Senior Research Analyst & MD

    Louise Alesandra Chen - Senior Research Analyst & MD

  • So my first question is that in consensus, there's a meaningful step-up in Ibrance sales through 2023.

    所以我的第一個問題是,大家一致認為,到 2023 年,Ibrance 的銷售額將有一個有意義的增長。

  • And do you think you can grow Ibrance double digits without an adjuvant or NEA adjuvant approval?

    你認為你可以在沒有佐劑或 NEA 佐劑批准的情況下將 Ibrance 增長兩位數嗎?

  • And then second question I had is on abrocitinib.

    然後我的第二個問題是關於 abrocitinib 的。

  • Based on the safety data that you've seen thus far, is there a chance that you will not get a black box warning like other JAKs we've seen in the industry?

    根據您目前看到的安全數據,您是否有可能不會像我們在業內看到的其他 JAK 那樣收到黑框警告?

  • And the last question I have was if you could give an update on your DMD program, where you stand today, the competitiveness of your program versus some of the other ones out there based on the data that you've seen thus far.

    我的最後一個問題是,你是否可以根據你迄今為止看到的數據,更新你的 DMD 計劃,你今天所處的位置,你的計劃與其他一些計劃的競爭力。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Yes.

    是的。

  • A quick answer on the Ibrance, and then I think abrocitinib and DMD will be covered by Mikael.

    關於 Ibrance 的快速回答,然後我認為 Abrocitinib 和 DMD 將由 Mikael 涵蓋。

  • Again, in the spirit that I don't want to comment what is the analysts' expectations, I know what they are, and I know what are our expectations.

    同樣,本著我不想評論分析師的期望是什麼的精神,我知道他們是什麼,我也知道我們的期望是什麼。

  • And we are projecting that we will grow Ibrance to double digit, and, therefore, also expecting that we will receive the -- that we will have, let's say, a positive PALLAS study, which is the main study that is driving expansion of prescriptions and drivers.

    我們預計我們將把 Ibrance 增長到兩位數,因此,我們也期待我們會收到——比方說,我們將擁有一項積極的 PALLAS 研究,這是推動處方擴展的主要研究和司機。

  • So, of course, everything is risk-adjusted in our projections.

    因此,當然,在我們的預測中,一切都經過風險調整。

  • And some will be positive, some will be negative, but the 6% that we are taking because the ratio on all of that is not based on 1 or 2, but is based on risk adjustment of multiple.

    有些會是正的,有些會是負的,但我們採用的 6% 是因為所有這些的比率不是基於 1 或 2,而是基於倍數的風險調整。

  • So we are feeling very comfortable that, overall, we will not say bad because if another fails, another one would succeed.

    因此,我們感到非常自在,總的來說,我們不會說不好,因為如果另一個人失敗了,另一個人就會成功。

  • And that one will derisk the revenue.

    而那個人會降低收入的風險。

  • So we'll be much higher.

    所以我們會更高。

  • Mikael?

    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。

  • So starting with abrocitinib.

    所以從 abrocitinib 開始。

  • I think it's a good question you raised here that each JAK inhibitor are different, and we designed our JAK inhibitors for optimal use depending on the condition.

    我認為你在這裡提出的每個 JAK 抑製劑都是不同的,這是一個很好的問題,我們設計了我們的 JAK 抑製劑,以根據條件實現最佳使用。

  • And it's hard for me to express a strong view here on the potential black box as it's really the decision of FDA.

    我很難在這裡對潛在的黑匣子表達強烈的看法,因為這實際上是 FDA 的決定。

  • I can only say that we have so far seen a very good safety profile, and we have not seen any cardiovascular signals at all with this drug.

    我只能說,到目前為止,我們已經看到了非常好的安全性,而且我們還沒有看到這種藥物有任何心血管信號。

  • And as you have seen in our reported trials, efficacy has been very persuasive and strong.

    正如您在我們報告的試驗中看到的那樣,療效一直非常有說服力和強大。

  • So we look forward to finalize the program, generate the compare data that could show potential advantages with faster onset versus standard-of-care Dupixent and then have dialogue with FDA.

    因此,我們期待完成該計劃,生成比較數據,以顯示與標準護理 Dupixent 相比起效更快的潛在優勢,然後與 FDA 進行對話。

  • The DMD program, we are continuing dosing patients and we reported at the PPMD conference that we had transduced more than 70% of the muscle fibers and expressed mini-dystrophin at 30% of normal that we think is in the range that -- where you should see benefit.

    DMD 計劃,我們正在繼續對患者進行給藥,我們在 PPMD 會議上報告說,我們已經轉導了超過 70% 的肌肉纖維,並以正常值的 30% 表達了微型抗肌萎縮蛋白,我們認為這個範圍是——應該看到好處。

  • Interestingly, we also shared with you, you seeing the Northstar Ambulatory activities game, that we had 2 patients where we saw benefit in increased performance.

    有趣的是,我們還與您分享,您看到 Northstar Ambulatory 活動遊戲,我們有 2 名患者在提高表現方面獲益。

  • And please remember, these patients were older than patients reported by other players in the field.

    請記住,這些患者比該領域其他參與者報告的患者年齡大。

  • And the older the patients are, the harder it is to show benefit, as their natural history is to decline.

    患者年齡越大,越難顯示出獲益,因為他們的自然病史正在下降。

  • So we are concluding we hope to study in a relative short time frame.

    所以我們得出結論,我們希望在相對較短的時間內學習。

  • And pending final data set, we are preparing for start of Phase 3 next year, and hope certainly that this type of therapy can transform patient lives for these poor boys.

    在等待最終數據集的情況下,我們正準備明年開始第 3 階段,並希望這種療法能夠改變這些可憐男孩的患者生活。

  • Operator

    Operator

  • Your final question comes from Geoff Meacham from Bank of America.

    你的最後一個問題來自美國銀行的 Geoff Meacham。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • I just had a few.

    我只有幾個。

  • Angela, for VYNDAQEL, I just want to get a little bit more detail on the rollout in the U.S. Obviously, I know it's early, but from the field, how would you characterize reimbursement and access?

    安吉拉,對於 VYNDAQEL,我只想了解更多關於在美國推出的細節。顯然,我知道現在還為時過早,但從現場來看,你如何描述報銷和訪問的特徵?

  • And are there commercial lessons to be learned from the EU?

    是否可以從歐盟吸取商業教訓?

  • And then, Albert, just to put a finer point on your comments for long-term growth and deals, I mean, when you look at the LOE starting in 2026, you mentioned the pipeline readouts as clearly an offset, but can that or smaller tuck-in deals be enough to still get you to growth over the course of the decade?

    然後,Albert,為了更好地說明您對長期增長和交易的評論,我的意思是,當您查看從 2026 年開始的 LOE 時,您提到管道讀數顯然是一個偏移量,但可以或更小折價交易是否足以讓您在十年內實現增長?

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • Angela?

    安吉拉?

  • Angela Hwang - Group President of Biopharmaceuticals Group

    Angela Hwang - Group President of Biopharmaceuticals Group

  • Great.

    偉大的。

  • So from a reimbursement perspective, I think that we are seeing things pan out exactly as we thought.

    所以從報銷的角度來看,我認為我們看到的事情完全按照我們的想法發展。

  • As you know, the large majority of our patients would be Medicare patients because the -- just the age and the prevalence of the disease in this particular population.

    如您所知,我們的絕大多數患者都是醫療保險患者,因為這個特定人群中的年齡和疾病患病率。

  • But currently, we're seeing about 80% of our patients be in the Medicare bucket, about 12% in the commercial lives bucket and then the remainder in Medicaid and others.

    但目前,我們看到大約 80% 的患者在 Medicare 範圍內,大約 12% 在商業生活範圍內,其餘在 Medicaid 和其他範圍內。

  • And so anticipating that this would be sort of how the patient -- I guess, the patient mix would look, we created, at the launch of VYNDAQEL, a number of programs to support the reimbursement of VYNDAQEL.

    因此,預計這將是患者的樣子——我猜,患者組合看起來,我們在 VYNDAQEL 推出時創建了許多計劃來支持 VYNDAQEL 的報銷。

  • And so for example, in the commercial patients, we have a co-pay card, a co-pay assistance program.

    因此,例如,在商業患者中,我們有一個共同支付卡,一個共同支付援助計劃。

  • For all patients, we have a bridge program to ensure that patients can receive access to VYNDAQEL while they are waiting for their reimbursement decisions.

    對於所有患者,我們都有一個過渡計劃,以確保患者在等待報銷決定時可以使用 VYNDAQEL。

  • And for Medicare patients, we're exploring -- we're in the process of exploring a number of ways that we can help lower co-pay costs for Medicare patients, including working with payers on innovative contracting approaches, which will then help to lower their co-pay.

    對於 Medicare 患者,我們正在探索——我們正在探索多種方法來幫助降低 Medicare 患者的共同支付成本,包括與付款人合作制定創新的合同方法,這將有助於降低他們的共付額。

  • And then, of course, there's always a portion of patients that are on our 3 drug program.

    然後,當然,總有一部分患者在我們的 3 種藥物計劃中。

  • But I think all in all, what we're learning from these early days in the market is that the solutions that we have are definitely supporting our patients in the way that they need.

    但我認為總而言之,我們從這些早期市場中學到的是,我們擁有的解決方案肯定會以他們需要的方式支持我們的患者。

  • And then not to forget, we still have the support from the Pfizer's patient hub as well as a number of specialty pharmacies and hospitals that actually provide our patients with all the support they need to clear their prior authorizations.

    然後不要忘記,我們仍然得到輝瑞患者中心以及許多專業藥房和醫院的支持,這些藥房和醫院實際上為我們的患者提供了他們獲得事先授權所需的所有支持。

  • And I think that this service has been hugely helpful in helping us to clear prior auths and get our patients on drug as soon as possible.

    而且我認為這項服務在幫助我們清除先前的授權並儘快讓我們的患者接受藥物方面非常有幫助。

  • Albert Bourla - CEO & Director

    Albert Bourla - CEO & Director

  • And Geoff, to your question about if we believe that this growth can be sustainable in the post 25, 26 period, the answer is yes.

    傑夫,關於我們是否相信這種增長在 25、26 歲後可持續發展的問題,答案是肯定的。

  • Look, it is normal for companies to have LOEs.

    你看,公司有LOE很正常。

  • What is abnormal is to not have LOEs, okay?

    不正常就是沒有LOE好嗎?

  • But it is normal for companies to have LOEs.

    但是公司有LOE很正常。

  • And ourselves, we will come back to normality.

    而我們自己,我們將恢復正常。

  • Actually, not even in 26.

    實際上,甚至在 26 歲時也沒有。

  • 26 is a very small number of LOEs.

    26 是極少數的 LOE。

  • From 27, we are coming back to normal LOEs as a percentage of sales.

    從 27 日起,我們將恢復到正常的 LOE 佔銷售額的百分比。

  • And then this we need to with everything that we know right now, normal in 27.

    然後我們需要用我們現在所知道的一切,在 27 歲時正常。

  • So this is 8 years from now, right?

    所以這是 8 年後,對吧?

  • So I feel very comfortable that we will have enough time and we have a pipeline that is very diversified, and we have a strategy that is doubled down on these to develop a substrate that would deliver on that.

    因此,我感到非常欣慰的是,我們將有足夠的時間,並且我們擁有非常多樣化的管道,並且我們的戰略是在這些方面加倍努力,以開發能夠實現這一目標的基質。

  • So when the company's on a normality, we'll be able to continue growing at the same rate that we are growing right now.

    因此,當公司處於正常狀態時,我們將能夠繼續以與現在相同的速度增長。

  • So I think that's the end, right?

    所以我認為這就是結束,對吧?

  • It's like, unfortunately, we don't have time.

    就像,不幸的是,我們沒有時間。

  • We exceeded our time.

    我們超出了時間。

  • So I want to thank you all for joining us today.

    所以我要感謝大家今天加入我們。

  • I liked a lot this call.

    我非常喜歡這個電話。

  • There were fewer questions on financials because they were stellar, of course.

    當然,關於財務的問題較少,因為它們很出色。

  • And we devoted most of the time to the pipeline, which is exactly what we want to do, and to the growth drivers of the business, which is exactly what an earnings call of a successful pharmaceuticals company should look like.

    我們把大部分時間都花在了管道上,這正是我們想要做的,以及業務的增長動力,這正是一家成功的製藥公司的盈利電話應該是什麼樣子的。

  • Now as we move toward the expected close of the Upjohn-Mylan transaction next year, I expect that both businesses will be significantly strengthened.

    現在我們正朝著明年 Upjohn-Mylan 交易的預期結束邁進,我預計這兩項業務都將得到顯著加強。

  • We expect Pfizer to remain positioned to deliver top and bottom line growth, that it's among the industry leaders.

    我們預計輝瑞(Pfizer)將繼續保持收入和利潤增長的地位,因為它是行業領導者之一。

  • And you know us.

    你了解我們。

  • We want to be the leader, so we will aim for that.

    我們想成為領導者,所以我們將以此為目標。

  • And by bringing together Mylan's growth products into Upjohn's growth markets, we are creating the leading off-patent drug company with a strong financial profile and true global reach.

    通過將 Mylan 的增長產品整合到 Upjohn 的增長市場,我們正在創建一家領先的非專利藥品公司,擁有強大的財務狀況和真正的全球影響力。

  • All these reasons, it is an exciting time for our company, and we will remain highly focused on executing against these strategies.

    由於所有這些原因,這對我們公司來說是一個激動人心的時刻,我們將繼續高度專注於執行這些戰略。

  • So thank you very much.

    非常感謝。

  • Have a great rest of the day.

    好好休息一天。

  • Operator

    Operator

  • Ladies and gentlemen, this does conclude Pfizer's Third Quarter 2019 Earnings Conference Call.

    女士們,先生們,輝瑞公司 2019 年第三季度收益電話會議到此結束。

  • Thank you for your participation.

    感謝您的參與。

  • You may now disconnect.

    您現在可以斷開連接。