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Operator
Operator
Good day, everyone, and welcome to Pfizer's First Quarter 2021 Earnings Conference Call. Today's call is being recorded.
大家好,歡迎參加輝瑞 2021 年第一季財報電話會議。今天的通話正在錄音。
At this time, I would like to turn the call over to Mr. Chuck Triano, Senior Vice President of Investor Relations. Please go ahead, sir.
現在,我想將電話轉給投資者關係高級副總裁 Chuck Triano 先生。請繼續,先生。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Thank you, operator. Good morning, and thanks for joining us today to review Pfizer's first quarter 2020 results and financial guidance update as well as other relevant business topics. I'm joined today as usual by our Chairman and CEO, Dr. Albert Bourla; Frank D'Amelio, our CFO; Mikael Dolsten, President of Worldwide Research and Development and Medical; Angela Hwang, Group President, Pfizer Biopharmaceuticals Group; John Young, our Chief Business Officer; and Doug Lankler, General Counsel.
謝謝你,接線生。早安,感謝您今天加入我們回顧輝瑞 2020 年第一季業績和財務指引更新以及其他相關業務主題。今天像往常一樣,我們的董事長兼執行長 Albert Bourla 博士也加入了我的行列。 Frank D'Amelio,我們的財務長; Mikael Dolsten,全球研發與醫療總裁; Angela Hwang,輝瑞生物製藥集團總裁;約翰‧楊,我們的首席商務官;和總法律顧問道格·蘭克勒 (Doug Lankler)。
The slides and the accompanying remarks that will be presented on this call were posted to our website earlier this morning and are available at pfizer.com/investors. You'll see here, on Slide 3, our disclaimer regarding forward-looking statements we will make during this call regarding, among other topics, our anticipated future operating and financial performance, business plans and prospects and expectations for our product pipeline and in-line products, which are subject to risks and uncertainties as well as the use of non-GAAP financial information.
本次電話會議將介紹的幻燈片和隨附評論已於今天早上早些時候發佈到我們的網站上,可在 pfizer.com/investors 上獲取。您將在幻燈片3 上看到我們關於我們將在本次電話會議期間做出的前瞻性聲明的免責聲明,這些聲明涉及我們預期的未來營運和財務業績、業務計劃和前景以及對我們的產品線和內部的期望。系列產品,這些產品受到風險和不確定性以及非公認會計準則財務資訊的使用的影響。
Additional information regarding forward-looking statements and our non-GAAP financial measures is available in our earnings release, including under the Disclosure Notice section and under Risk Factors in our SEC Forms 10-K and 10-Q. Forward-looking statements on this call speak only as of the original date of this call, and we undertake no obligation to update or revise any of the statements. Albert and Frank will now make prepared remarks and then we'll move to a question-and-answer session.
有關前瞻性陳述和我們的非 GAAP 財務指標的更多信息,請參閱我們的收益報告,包括披露聲明部分以及 SEC 表格 10-K 和 10-Q 中的風險因素。本次電話會議中的前瞻性陳述僅代表本次電話會議原始日期的情況,我們不承擔更新或修改任何陳述的義務。艾伯特和弗蘭克現在將發表準備好的講話,然後我們將進入問答環節。
With that, I'll now turn the call over to Albert Bourla. Albert?
現在,我將把電話轉給阿爾伯特·布拉 (Albert Bourla)。阿爾伯特?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Chuck, and hello, everyone.
謝謝你,查克,大家好。
I couldn't be prouder of the way Pfizer has started 2021. During the first quarter, we delivered strong financial results. Even excluding the revenue provided from our COVID-19 vaccine, our revenues grew 8% operationally, 10% reported, and this 8% growth includes a negative 5% impact from pricing. We continued to accelerate production and shipments of our COVID-19 vaccine, in many cases, exceeding our contractual obligations for delivery timelines. And we achieved several important clinical, regulatory and commercial milestones.
我對輝瑞 2021 年伊始的方式感到無比自豪。第一季度,我們取得了強勁的財務表現。即使不包括我們的 COVID-19 疫苗提供的收入,我們的營運收入也增長了 8%(據報告為 10%),而這 8% 的增長包括定價帶來的 5% 的負面影響。我們繼續加快 COVID-19 疫苗的生產和發貨,在許多情況下,超出了我們交付時間表的合約義務。我們實現了幾個重要的臨床、監管和商業里程碑。
Let me start with commentary on some of our biggest growth drivers in this quarter. The Pfizer-BioNTech COVID-19 vaccine contributed $3.5 billion in global revenues during the first quarter. As of May 3, 2021, Pfizer, along with its partner BioNTech, has shipped approximately 430 million doses of the vaccine to 91 countries and territories around the world. I will share some thoughts on the sustainability of this revenue stream later in my remarks.
讓我先對本季一些最大的成長動力進行評論。輝瑞-BioNTech COVID-19疫苗第一季為全球貢獻了35億美元的收入。截至2021年5月3日,輝瑞與其合作夥伴BioNTech已向全球91個國家和地區運送了約4.3億劑疫苗。我將在稍後的發言中分享一些關於這個收入來源的可持續性的想法。
Eliquis has continued to deliver a strong performance with revenues up 25% operationally to $1.6 billion in the first quarter. In the U.S., Eliquis sales growth was driven mainly by strong volume growth.
Eliquis 持續表現強勁,第一季營運收入成長 25%,達到 16 億美元。在美國,Eliquis 的銷售成長主要是由銷售的強勁成長所推動的。
Vyndaqel and Vyndamax generated revenues of $453 million, representing operational growth of 88%. Our disease education efforts in the U.S. continue to support appropriate diagnosis, increasing the estimated diagnosis rate to almost 24% at quarter end, up from 21% at the end of 2020. At the end of the quarter, more than 23,500 patients have been diagnosed, more than 17,000 patients have received a prescription and more than 10,500 patients have received the drug, including patients who received the drug at no cost through our patient assistance programs. While there are still regional differences in cardiology activity and elective diagnostic procedures due to COVID-19 guidelines, on a national basis, diagnosis rate in the U.S. have now recovered and exceed pre-COVID levels as compared with the first quarter of 2020. We also have seen strong growth from Japan and from developed Europe, where it's the largest contributor to our revenues outside the U.S.
Vyndaqel 和 Vyndamax 的營收為 4.53 億美元,營運成長 88%。我們在美國的疾病教育工作繼續支持適當的診斷,將估計診斷率從 2020 年底的 21% 提高到季度末的近 24%。截至本季度末,已有超過 23,500 名患者被診斷出,超過17,000 名患者已收到處方,超過10,500 名患者已收到藥物,其中包括透過我們的患者援助計劃免費獲得藥物的患者。儘管由於COVID-19 指南的影響,心臟病學活動和選擇性診斷程序仍存在地區差異,但從全國範圍來看,與2020 年第一季相比,美國的診斷率現已恢復並超過了新冠疫情前的水準。我們也來自日本和已開發歐洲的強勁成長,是我們在美國以外收入的最大貢獻者。
Xeljanz also performed well with global revenues up 18% operationally to $538 million. The growth was primarily driven by 16% growth in the U.S. and 14% growth operationally in international developed markets. The underlying prescription demand in the U.S. grew 9% compared with the first quarter of 2020, outpacing the advanced therapy market by 3 percentage points. We have invested in formulary access in the U.S., which has played a vital role in enabling this volume growth.
Xeljanz 也表現出色,全球營運收入成長 18%,達到 5.38 億美元。這一成長主要是由美國 16% 的成長和國際已開發市場 14% 的營運成長所推動的。與 2020 年第一季相比,美國的基本處方需求增加了 9%,比先進治療市場高出 3 個百分點。我們在美國投資了處方藥准入,這在實現銷售成長方面發揮了至關重要的作用。
In the U.S., Ibrance revenues declined 7% compared with the year ago quarter. Total prescription volume is relatively stable, and we continue to be the leading product in the CDK class by a wide range with an 84% of total patient share in first-line use. However, we saw increased enrollment this quarter in our Patient Assistance Program, which provides Ibrance free of charge to certain low-income patients. We believe this increase is due to COVID-19-related economic hardships that are affecting particularly the demographics of the Ibrance patient population, and we do expect this to normalize over time as the economic impact from the pandemic subsides.
在美國,Ibrance 收入較去年同期下降 7%。總處方量相對穩定,我們繼續在 CDK 類別中處於領先地位,在一線使用中佔患者總數的 84%。然而,本季度我們的患者援助計劃的註冊人數有所增加,該計劃向某些低收入患者免費提供 Ibrance。我們認為,這一增長是由於與COVID-19 相關的經濟困難造成的,這些困難尤其影響了Ibrance 患者群體的人口統計數據,而且我們確實預計,隨著大流行對經濟的影響消退,這種情況會隨著時間的推移而正常化。
As of mid-April, we had contracted for approximately 1.6 billion doses of our COVID-19 vaccine expected to be delivered in 2021. As a result, based on the contracts signed through mid-April, we are increasing our revenue guidance and now expect revenues of approximately $26 billion from the vaccine in 2021. We also are in ongoing discussions with multiple countries around the world about their needs, and we expect these discussions to lead to additional supply agreements.
截至 4 月中旬,我們已簽訂了約 16 億劑 COVID-19 疫苗的合同,預計將於 2021 年交付。因此,根據截至 4 月中旬簽署的合同,我們正在提高收入指導,現在預計到2021 年,該疫苗的收入約為260 億美元。我們也正在與世界多個國家持續討論他們的需求,我們預計這些討論將導致達成額外的供應協議。
Based on what we have seen, we believe that a durable demand from our COVID-19 vaccine, similar to that of the flu vaccines, is a likely outcome. We want to be a long-term partner to health authorities around the world in their ongoing efforts to combat COVID-19, including their planning for an ongoing pandemic vaccination approach that is fit-for-purpose to local requirements. To that end, together with our partner, BioNTech, we expect to have the capacity to manufacture at least 3 billion doses in 2022.
根據我們所看到的情況,我們認為,與流感疫苗類似,我們的 COVID-19 疫苗的持久需求可能是結果。我們希望成為世界各地衛生當局持續努力對抗 COVID-19 的長期合作夥伴,包括他們規劃符合當地要求的持續大流行疫苗接種方法。為此,我們與我們的合作夥伴 BioNTech 一起,預計到 2022 年將有能力生產至少 30 億劑疫苗。
We are in discussions with a number of countries around the world for multiyear contracts for the potential supply of COVID-19 vaccine doses during '22 and beyond. In fact, we recently signed an agreement with the U.K. to supply 60 million additional doses in 2021 and with Israel to supply millions of doses in 2022, enough for the government to boost every eligible citizen, subject to local guidelines, with the option to purchase millions of additional doses for additional boosters. We have also reached an agreement with Canada to supply up to 125 million doses in '22 and '23, with options to supply up to 60 million additional doses in 2024.
我們正在與世界各地的許多國家討論多年期合同,以便在 22 年及以後供應 COVID-19 疫苗劑量。事實上,我們最近與英國簽署了一項協議,將在2021 年額外供應6000 萬劑疫苗,並與以色列在2022 年額外供應數百萬劑疫苗,這足以讓政府根據當地指導方針為每一位符合資格的公民提供疫苗接種,並可以選擇購買數百萬的額外劑量用於額外的加強劑。我們也與加拿大達成協議,將在 22 年和 23 年供應最多 1.25 億劑疫苗,並可選擇在 2024 年額外供應高達 6,000 萬劑疫苗。
It is our hope that the Pfizer-BioNTech vaccine will continue to have a global impact by helping to get the devastating pandemic under control and helping economies around the world not only open but stay open, creating a scenario in which Pfizer can continue to be both a leader and a beneficiary. To realize this goal, we are continuing to lead with strong science not only to maximize the impact of our COVID-19 vaccine in preventing disease but also with the work we are doing to develop 2 potential novel protease inhibitors, one administered intravenously and one administered orally.
我們希望輝瑞-BioNTech 疫苗將繼續產生全球影響,幫助控制這場毀滅性的大流行,幫助世界各地的經濟體不僅開放而且保持開放,創造一個輝瑞能夠繼續保持開放的局面。既是領導者又是受益者。為了實現這一目標,我們將繼續以強大的科學引領,不僅最大限度地發揮我們的COVID-19 疫苗在預防疾病方面的影響,而且我們正在開發2 種潛在的新型蛋白酶抑制劑,一種是靜脈注射,另一種是口服口頭。
As you can see on the accompanying slide, we have many clinical studies ongoing and expect to have multiple readouts and submissions throughout the remainder of the year. Let me touch on a few. First, while we are currently distributing our vaccine in the U.S. under an Emergency Use Authorization, we expect to submit this month a Biologics License Application to the U.S. Food and Drug Administration seeking full approval for our COVID-19 vaccine for individuals 16 years of age and older.
正如您在隨附的幻燈片中所看到的,我們正在進行許多臨床研究,預計在今年剩餘時間內會有多次讀數和提交。讓我談談一些。首先,雖然我們目前正在根據緊急使用授權在美國分發我們的疫苗,但我們預計本月將向美國食品和藥物管理局提交生物製品許可證申請,尋求我們針對16 歲個人的COVID-19 疫苗的完全批准和年紀大了。
Second, we are evaluating the safety and immunogenicity of a third dose of the existing formulation of our COVID-19 vaccine to understand the effect of a booster on immunity against the SARS-CoV-2 variants in circulation. Additionally, we have started an evaluation of an updated, prototype variant version of our vaccine that encodes the spike protein of the lineage B.1.351 SARS-CoV-2 variant, which includes the mutation E484K, first identified in South Africa. This study is designed to establish a regulatory pathway to update the current vaccine to address any future variant of potential concern in approximately 100 days, if needed. We expect to have immunogenicity data for both studies in early July.
其次,我們正在評估第三劑 COVID-19 疫苗現有配方的安全性和免疫原性,以了解加強劑對循環中 SARS-CoV-2 變異體免疫的影響。此外,我們已開始對疫苗的更新原型變體版本進行評估,該疫苗編碼 B.1.351 SARS-CoV-2 譜系變體的刺突蛋白,其中包括在南非首次發現的突變 E484K。這項研究旨在建立一條監管途徑來更新當前的疫苗,以在需要時解決大約 100 天內潛在問題的任何未來變體。我們預計將在 7 月初獲得這兩項研究的免疫原性數據。
Third, we are continuing our efforts to evaluate the Pfizer-BioNTech COVID-19 vaccine in additional populations. We expect to hear back shortly from the FDA on our application for expanded Emergency Use Authorization for our COVID-19 vaccine to include individuals 12 to 15 years of age. The Pfizer-BioNTech pediatric study evaluating the safety and efficacy of our COVID-19 vaccine in children 6 months to 11 years of age is ongoing. We expect to have definite readouts and submit for an EUA for 2 cohorts, including children 2 to 5 years of age and 5 to 11 years of age in September. The readout and submission for the cohort of children 6 months to 2 years old are expected in the fourth quarter. We also expect to have Phase 2 safety data from our ongoing study in pregnant women by late July, early August.
第三,我們正在繼續努力在其他族群中評估輝瑞 BioNTech COVID-19 疫苗。我們預計很快就會收到 FDA 的回复,申請擴大我們的 COVID-19 疫苗緊急使用授權,以涵蓋 12 至 15 歲的個人。輝瑞-BioNTech 兒科研究正在評估我們的 COVID-19 疫苗對 6 個月至 11 歲兒童的安全性和有效性。我們預計將在 9 月獲得明確的讀數並提交 2 組兒童的 EUA,其中包括 2 至 5 歲和 5 至 11 歲的兒童。預計在第四季度公佈並提交 6 個月至 2 歲兒童群體的數據。我們也預計在 7 月底、8 月初之前獲得我們正在進行的針對孕婦的研究的第 2 階段安全數據。
Fourth, we are making progress with improving the stability of our COVID-19 vaccine. On Friday, we submitted new stability data to the FDA, and we believe we could soon receive an update to our EUA prescribing information, allowing the vaccine to be stored at standard refrigerator temperatures of 2 to 8 degrees Celsius for up to 4 weeks. We are also working on a ready-to-use formulation that, subject to generating supportive stability data and obtaining regulatory approval, could potentially be stored at standard refrigerator temperatures for up to 10 weeks and up to 6 months at minus 50 to minus 70. If successful, we expect to have the data to support this formulation in August.
第四,我們在提高 COVID-19 疫苗的穩定性方面取得了進展。週五,我們向 FDA 提交了新的穩定性數據,我們相信我們很快就會收到 EUA 處方資訊的更新,允許疫苗在 2 至 8 攝氏度的標準冰箱溫度下保存長達 4 週。我們也正在研究一種即用型配方,在產生支持性穩定性數據並獲得監管部門批准的情況下,該配方有可能在標準冰箱溫度下儲存長達10 週,在-50 至-70 的溫度下最多可儲存6 個月。如果成功,我們預計在八月獲得支持這項設想的數據。
Fifth, as we move closer to a potential approval for our investigational 20-valent pneumococcal conjugate vaccine for adults, which, if approved, may be launched during an ongoing pandemic, we plan to begin this month a study of co-administration of the Pfizer-BioNTech COVID-19 vaccine with the 20-valent pneumococcal conjugate vaccine.
第五,隨著我們正在研究的成人 20 價肺炎球菌結合疫苗即將獲得批准(如果獲得批准,可能會在持續的大流行期間推出),我們計劃於本月開始一項輝瑞聯合用藥的研究-BioNTech COVID-19 疫苗與20 價肺炎鏈球菌結合疫苗。
Moving to COVID-19 treatments now. We have early studies ongoing for 2 protease inhibitors antiviral candidates, one administered intravenously and one orally. We expect to begin our Phase 2/3 study for the intravenously administered compound in May and for the orally administered compound in July. With regard to our oral protease inhibitor, we are planning to evaluate its safety and efficacy through 3 development pathways.
現在轉向 COVID-19 治療。我們正在進行兩種蛋白酶抑制劑抗病毒候選藥物的早期研究,一種是靜脈注射,另一種是口服。我們預計將於 5 月開始靜脈注射化合物的 2/3 期研究,並於 7 月開始口服化合物的 2/3 期研究。對於我們的口服蛋白酶抑制劑,我們計劃透過3個開發途徑評估其安全性和有效性。
We are studying it compared to a placebo to confirm whether it is efficacious against COVID-19. We are studying it against monoclonal antibodies to assess relative efficacy against current circulating strains. Mutations of spike protein may lead to diminished efficacy of presently available monoclonal antibodies, and our intent is to bring about a therapy with durable efficacy through a different mechanism of action and conservation of the 3CL protein.
我們正在將其與安慰劑進行比較,以確認它是否對 COVID-19 有效。我們正在針對單株抗體研究它,以評估針對目前流行菌株的相對功效。刺突蛋白的突變可能會導致目前可用的單株抗體的功效減弱,我們的目的是透過不同的作用機制和 3CL 蛋白的保護來實現具有持久功效的治療方法。
Also, we are studying it in unvaccinated household contacts exposed to someone infected with COVID-19 to evaluate if it prevents close contacts from contracting COVID-19. It has been well established with flu antiviral drugs that administering them to close contacts of subjects who have flu reduces the chance of them also getting flu by more than 80%. Though SARS-CoV-2 is a different virus than flu, we are hopeful the principle will be the same: If we administer the investigational treatment to those who are at risk from close contact, does it prevent them from getting sick. As you can see on our timeline, if things go well, we could potentially apply for approvals before the end of the year.
此外,我們正在對接觸過 COVID-19 感染者的未接種疫苗的家庭接觸者進行研究,以評估它是否可以防止密切接觸者感染 COVID-19。流感抗病毒藥物已被證實,給流感患者的密切接觸者服用這些藥物可以減少 80% 以上的流感風險。儘管 SARS-CoV-2 是一種與流感不同的病毒,但我們希望原理是相同的:如果我們對那些有密切接觸風險的人進行研究治療,是否可以防止他們生病。正如您在我們的時間表上看到的,如果一切順利,我們可能會在今年年底之前申請批准。
The intravenously administered protease inhibitor is being studied in in-patient Phase 1b studies in the U.S., Spain, Belgium and Brazil. We expect to begin a Phase 2/3 study in which the IV compound will be tested against the current standard of care this quarter. With the current unmet global medical need for antivirals, we are constantly assessing how we can accelerate the development of these potential treatments.
這種靜脈注射的蛋白酶抑制劑正在美國、西班牙、比利時和巴西進行住院 1b 期研究。我們預計將在本季度開始一項 2/3 期研究,其中 IV 化合物將根據當前的護理標準進行測試。鑑於目前全球抗病毒藥物的醫療需求尚未得到滿足,我們不斷評估如何加速這些潛在治療方法的發展。
Pfizer has emerged as a leader in mRNA development, and we are exploring a wide range of opportunities for the technology. We are making rapid progress with our potential flu mRNA program, and we aim to maintain mRNA leadership with 2 potential game-changing mRNA approaches to a flu vaccine expected to enter the clinic in the third quarter of 2021.
輝瑞已成為 mRNA 開發領域的領導者,我們正在探索該技術的廣泛機會。我們潛在的流感 mRNA 計畫正在快速取得進展,我們的目標是透過兩種潛在的、改變遊戲規則的流感疫苗 mRNA 方法來保持 mRNA 的領先地位,預計將於 2021 年第三季度進入臨床。
We will test multiple constructs in Phase 1/2 to facilitate swift selection of an optimal tetravalent flu product dose regimen. We aim to develop initially a tetravalent flu vaccine using the modified mRNA platform. Pending the generation of favorable immune and tolerability Phase 1/2 data, a potential rapid progression to Phase 3 is possible given our large-scale pharmaceutical science and manufacturing capabilities. We are also exploring the potential to address other infectious diseases that we plan to discuss in the near future.
我們將在 1/2 期測試多種構建體,以促進快速選擇最佳的四價流感產品劑量方案。我們的目標是先使用改良的 mRNA 平台開發四價流感疫苗。在產生有利的免疫和耐受性 1/2 期數據之前,鑑於我們大規模的製藥科學和製造能力,有可能快速進展到 3 期。我們也正在探索解決我們計劃在不久的將來討論的其他傳染病的潛力。
In addition to prophylactic vaccines for infectious diseases, we believe mRNA has the potential to address a wide range of therapeutic areas, including cancer and genetic disease. As you have seen, today, we have increased our 2021 R&D guidance to reflect our plans to increase our mRNA capabilities, build momentum in our targeted areas of interest and deliver on mRNA's breakthrough potential for the benefit of people worldwide. You can expect to hear more about our plans and potential applications in the coming weeks.
除了傳染病的預防性疫苗外,我們相信 mRNA 還具有解決廣泛治療領域的潛力,包括癌症和遺傳疾病。正如您所看到的,今天,我們增加了 2021 年研發指導,以反映我們提高 mRNA 能力的計劃,在我們感興趣的目標領域建立動力,並發揮 mRNA 的突破性潛力,造福全世界人民。您可以期待在未來幾週內聽到更多有關我們的計劃和潛在應用的信息。
Now let's turn to Pfizer R&D pipeline, which continues to be one of the great strengths. Our pipeline currently includes 99 potential new therapies or indications. That's 99 potential opportunities to change the lives of patients around the world. I will now provide an update on some of these exciting candidates.
現在讓我們來看看輝瑞的研發管線,它仍然是其最大的優勢之一。我們的產品線目前包括 99 種潛在的新療法或適應症。這是改變世界各地患者生活的 99 個潛在機會。我現在將提供其中一些令人興奮的候選人的最新資訊。
In Vaccines, as referenced earlier, the FDA is reviewing the Biologic License Application for our investigational 20-valent pneumococcal conjugate vaccine for adults 18 years of age and older with a PDUFA date in June of 2021. Among pneumococcal conjugate vaccines on the market or in late-stage development, if approved, we believe it could provide the most comprehensive coverage against pneumococcal pneumonia disease in adults.
在疫苗方面,如前所述,FDA 正在審查我們針對 18 歲及以上成人的研究性 20 價肺炎球菌結合疫苗的生物許可證申請,其 PDUFA 日期為 2021 年 6 月。後期開發如果獲得批准,我們相信它可以提供針對成人肺炎球菌肺炎的最全面的覆蓋。
In Internal Medicine, in December of 2020, we entered into a collaboration with Myovant Sciences to commercialize relugolix combination therapy with uterine fibroids and endometriosis pending FDA approval as well as relugolix for advanced prostate cancer. We are excited about the prospect of soon commercializing this product for its potential indication of uterine fibroids, if approved. And the FDA has a PDUFA date of June 1, 2021. An estimated 5 million women in the U.S. suffer from symptoms of uterine fibroids, and an estimated 3 million women are inadequately treated by current therapy and require further treatment. We are also working on our planned FDA submission for the endometriosis indication, which we hope to submit this year. An estimated 6 million women in the U.S. suffer from symptoms of endometriosis, and an estimated 1 million women are inadequately treated by current therapy and require further treatment, unfortunately.
在內科領域,2020 年 12 月,我們與 Myovant Sciences 合作,將用於治療子宮肌瘤和子宮內膜異位症的 relugolix 聯合療法以及用於晚期前列腺癌的 relugolix 商業化,以待 FDA 批准。如果獲得批准,我們對該產品很快商業化的前景感到興奮,因為它具有子宮肌瘤的潛在適應症。 FDA 的 PDUFA 日期為 2021 年 6 月 1 日。估計美國有 500 萬名女性患有子宮肌瘤症狀,估計有 300 萬名女性目前的治療效果不佳,需要進一步治療。我們也正在計劃向 FDA 提交子宮內膜異位症適應症的申請,我們希望今年提交。據估計,美國有 600 萬名女性患有子宮內膜異位症症狀,不幸的是,目前的治療方法估計有 100 萬名女性未得到充分治療,需要進一步治療。
In Inflammation and Immunology, alopecia areata is an immune disease that causes hair loss and has no approved treatments in the U.S. and Europe. The Phase 2b/3 pivotal clinical trial to evaluate our JAK3/TEC inhibitor ritlecitinib in alopecia areata is expected to read out late in the third quarter of 2021. If approved, ritlecitinib has the potential to transform the lives of certain patients with this condition.
在發炎和免疫學領域,斑禿是一種導致脫髮的免疫性疾病,在美國和歐洲尚未獲得批准的治療方法。評估我們的 JAK3/TEC 抑制劑 Ritlecitinib 治療斑禿的 2b/3 期關鍵臨床試驗預計將於 2021 年第三季末公佈。如果獲得批准,Ritlecitinib 有可能改變某些患有這種疾病的患者的生活。
The FDA has extended the priority review period of our New Drug Application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The PDUFA date has been extended 3 months to early third quarter 2021 as the FDA has requested additional information and will require additional time to review this data. We believe in the efficacy and safety profile of abrocitinib, which was demonstrated in Phase 3 clinical trial of more than 2,800 patients. We look forward to working with the FDA and other regulators around the world over the coming months to potentially help bring this important option to patients.
FDA 延長了 abrocitinib 用於治療成人和青少年中度至重度異位性皮膚炎的新藥申請的優先審查期。由於 FDA 要求提供更多信息,並且需要更多時間來審查這些數據,因此 PDUFA 日期已延長 3 個月,至 2021 年第三季初。我們相信 abrocitinib 的功效和安全性,這一點已在超過 2,800 名患者參與的 3 期臨床試驗中得到證實。我們期待在未來幾個月內與 FDA 和世界各地的其他監管機構合作,以幫助為患者帶來這一重要的選擇。
It is important to note that each JAK inhibitor is unique and potential risk identified in one molecule do not necessarily implicate other molecules. We continue to remain confident in the importance of a JAK inhibitor class for appropriate patients with inflammatory diseases given the role of JAK pathways in inflammatory processes. Patient safety is of utmost importance, and we continue to monitor all compounds in our portfolio to identify signals both in development as well as after regulatory approval.
值得注意的是,每種 JAK 抑制劑都是獨特的,在一個分子中發現的潛在風險並不一定涉及其他分子。鑑於 JAK 路徑在發炎過程中的作用,我們仍然相信 JAK 抑制劑類藥物對於適當的發炎性疾病患者的重要性。病患安全至關重要,我們將繼續監控我們產品組合中的所有化合物,以識別開發中以及監管部門批准後的訊號。
In Oncology, we continue to evaluate talazoparib in 3 studies in prostate cancer. The first is TALAPRO-1, a Phase 2 study in second-line plus patients with DDR mutations, which recently had a positive readout as a monotherapy, providing the key proof of concept to move forward to prostate cancer combination studies. The second is TALAPRO-2, a Phase 3 study in first-line metastatic castration-resistant prostate cancer in an unselected population for which the primary completion date is expected in the second half of 2021. And finally, TALAPRO-3, which is beginning soon and will study talazoparib in combination with enzalutamide in DDR-deficient metastatic castration-sensitive prostate cancer.
在腫瘤學方面,我們繼續在 3 項前列腺癌研究中評估他佐帕尼。第一個是TALAPRO-1,一項針對二線及DDR突變患者的2期研究,該研究最近作為單一療法取得了積極的結果,為推進前列腺癌聯合研究提供了關鍵的概念證明。第二個是TALAPRO-2,這是一項針對未選定人群的一線轉移性去勢抵抗性前列腺癌的3 期研究,預計主要完成日期為2021 年下半年。最後是TALAPRO-3,該研究正在開始很快,我們將研究他拉佐帕尼(talazoparib)與恩雜魯胺(enzalutamide)聯合治療 DDR 缺陷的轉移性去勢敏感前列腺癌。
In February 2021, we announced that the first participant has been dosed in the registration-enabling Phase 2 MagnetisMM-3 study of elranatamab, an investigational B-cell maturation antigen CD3-targeted bispecific antibody, in patients with relapsed/refractory multiple myeloma. New enrollment in this study has been paused while we provide additional information to the FDA regarding 3 cases of peripheral neuropathy observed in the ongoing Phase 1 MagnetisMM-1 study. Patients who are deriving clinical benefits from elranatamab may continue treatment.
2021 年2 月,我們宣布elranatamab(一種研究性B 細胞成熟抗原CD3 靶向雙特異性抗體)在復發/難治性多發性骨髓瘤患者中進行的註冊2 期MagnetisMM-3 研究中,第一位參與者已接受給藥。這項研究的新招募已暫停,同時我們向 FDA 提供有關正在進行的 1 期 MagnetisMM-1 研究中觀察到的 3 例周圍神經病變病例的更多資訊。從 elranatamab 獲得臨床益處的患者可以繼續治療。
In Rare Disease, our Phase 3 lead-in study for the gene therapy fidanacogene elaparvovec in hemophilia B has now been fully enrolled with more than 40 patients. We remain on course to complete dosing and expect to conduct a planned interim analysis for a potential data readout in this year, in 2021. We also continue to progress our hemophilia A gene therapy, giroctocogene fitelparvovec, which was developed in collaboration with Sangamo Therapeutics. We anticipate presenting 2-year Phase 1/2 data in the fourth quarter of 2021. Additionally, we are pleased to report that our lead-in study for our Phase 3 AFFINE study is in hemophilia A now fully enrolled, which could lead to a pivotal readout in 2022.
在罕見疾病領域,我們針對 B 型血友病基因療法 fidanacogene elaparvovec 的 3 期導入研究現已全面入組,共有 40 多名患者參與。我們仍在完成給藥的過程中,並期望對今年即 2021 年的潛在數據讀數進行計劃中的中期分析。我們還繼續推進我們與 Sangamo Therapeutics 合作開發的 A 型血友病基因療法 giroctocogene fitelparvovec。我們預計在 2021 年第四季提供為期 2 年的 1/2 期數據。此外,我們很高興地報告,我們 3 期 AFFINE 研究的先導研究目前已完全入組 A 型血友病,這可能會導致2022 年的關鍵讀數。
For our gene therapy candidate for Duchenne muscular dystrophy, we now have an approved generic name, fordadistrogene movaparvovec, and we are progressing our Phase 3 trial, CIFFREO. To date, we have opened 15 trial sites in 8 countries: Italy, Spain, Israel, the U.K., South Korea, Japan, Russia and Canada. In the U.S., we are actively working with the FDA to address outstanding questions related to our investigational new drug application, including technical aspects of our potency assay matrix, so that we can begin enrolling patients in Phase 3 U.S. study sites.
對於杜氏肌肉營養不良症的候選基因治療藥物,我們現在有了一個已批准的通用名:fordadistrogene movaparvovec,並且我們正在推進我們的 3 期試驗 CIFFREO。迄今為止,我們已在 8 個國家開設了 15 個試驗點:義大利、西班牙、以色列、英國、韓國、日本、俄羅斯和加拿大。在美國,我們正在積極與 FDA 合作,解決與我們的研究性新藥申請相關的突出問題,包括我們的效力測定矩陣的技術方面,以便我們可以開始在美國 3 期研究中心招募患者。
While we have high confidence in our current quality control overall and with a potency assay matrix which has been accepted in countries outside of the U.S., the FDA has additional technical requests that we are working to address as quickly as possible. We understand the sense of urgency among many families in the U.S. who are hoping for sites to open soon. While we cannot speculate at this time as to when sites may open in the U.S., we do not expect a resolution in the first half of 2021. We are working with a sense of urgency and hope to reach alignment with the FDA as soon as possible. In the interim, we will continue to progress our trial globally and enroll patients at other sites, which we believe will allow our program to remain on track to potentially enable approvals around the world, including the U.S.
雖然我們對目前的整體品質控制以及美國以外國家/地區已接受的效力測定矩陣充滿信心,但 FDA 還有其他技術要求,我們正在努力盡快解決。我們理解許多美國家庭的緊迫感,他們希望網站能夠盡快開放。雖然我們目前無法推測何時可以在美國開設網站,但我們預計 2021 年上半年不會有解決方案。我們正在帶著緊迫感開展工作,希望盡快與 FDA 達成協議。在此期間,我們將繼續在全球範圍內推進我們的試驗,並在其他地點招募患者,我們相信這將使我們的計畫繼續走上正軌,並有可能在包括美國在內的世界各地獲得批准。
Now I would like to address a key policy issue in which we continue to be actively engaged: affordable access. We expect the Biden administration will soon announce a human capital component to their infrastructure package that will include health provisions. Pfizer is mobilizing to work with the administration as well as lawmakers in both political parties on meaningful solutions for patient access. Specifically, there are 3 key areas where we would like to see Congress and the administration focus: rebate reform, capping beneficiary cost-sharing in Medicare Part D and incentivizing the uptake of biosimilars.
現在我想談談我們繼續積極參與的一個關鍵政策議題:負擔得起的接觸。我們預計拜登政府將很快宣布其基礎設施計劃中的人力資本部分,其中將包括衛生設施。輝瑞正在動員與政府以及兩黨的立法者合作,為病人取得有意義的解決方案。具體來說,我們希望國會和政府專注於三個關鍵領域:回扣改革、限制醫療保險 D 部分的受益人分攤費用以及激勵生物相似藥的採用。
At the state level, we have focused our efforts on meaningful solutions to directly address patient affordability challenges. This includes legislation to require 100% of negotiated rebates to be passed through to consumers at the pharmacy counter. We have also worked with state policymakers to advance legislation in several states, ensuring that patient assistance provided by manufacturers will count towards the patient's deductible and out of pocket maximums.
在州一級,我們將工作重點放在有意義的解決方案上,以直接解決患者負擔能力的挑戰。這包括立法要求將 100% 的協商回扣轉嫁給藥局櫃檯的消費者。我們也與州政策制定者合作,推動多個州的立法,確保製造商提供的患者援助將計入患者的免賠額和自付費用最高限額。
Looking ahead, we remain focused on being nimble and investing in our R&D organization so we can build on the strong improvement in the clinical success rates that had been seen over the past 5 years and potentially translate that success into strong commercial launches that benefit patients. Excluding any impact from our COVID-19 vaccine, we are on track and continue to expect a revenue CAGR of at least 6% on a risk-adjusted basis through the end of 2025 as well as double-digit growth on the bottom line.
展望未來,我們仍然專注於保持靈活性並投資於我們的研發組織,以便我們能夠在過去5 年臨床成功率的強勁提高的基礎上再接再厲,並有可能將這種成功轉化為造福患者的強大商業發布。排除我們的 COVID-19 疫苗的任何影響,我們正步入正軌,並繼續預計到 2025 年底,經風險調整後的收入複合年增長率至少為 6%,淨利潤將實現兩位數增長。
We remain very confident in our ability to achieve these growth rates because of the strength of both our current product portfolio and our R&D pipeline. At the same time, we will continue to pursue business development opportunities with the potential to further enhance our long-term growth prospects. Just last week, for example, Pfizer acquired Amplyx Pharmaceuticals, a privately held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems. Amplyx's lead compound is a novel investigational asset under development for the treatment of invasive fungal infection.
由於我們目前產品組合和研發管道的實力,我們對實現這些成長率的能力仍然非常有信心。同時,我們將繼續尋求有潛力的業務發展機會,以進一步增強我們的長期成長前景。例如,就在上週,輝瑞收購了 Amplyx Pharmaceuticals,這是一家私人公司,致力於開發治療影響免疫系統受損患者的衰弱和危及生命的疾病的療法。 Amplyx 的先導化合物是一種正在開發的新型研究資產,用於治療侵襲性真菌感染。
Thank you. And now I will pass the stage to our CFO, Frank D'Amelio.
謝謝。現在我將把舞台交給我們的財務長 Frank D'Amelio。
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Thank you, Albert. Good day, everyone. I know you've seen our release so let me provide a few highlights regarding the financials. Clearly, the COVID-19 vaccine has had a dramatic positive impact on our year-over-year results, and Albert has addressed the key points on the COVID-19 vaccine landscape.
謝謝你,艾伯特。今天是個好日子。我知道您已經看過我們的新聞稿,所以讓我提供一些有關財務狀況的要點。顯然,COVID-19 疫苗對我們的年比業績產生了巨大的正面影響,Albert 也談到了 COVID-19 疫苗領域的關鍵點。
Looking at the income statement, revenue and Adjusted cost of sales was significantly impacted by COVID-19 vaccine sales and the associated 50% gross profit split with BioNTech, which we recognize on the cost of sales line. Revenue increased 42% operationally in the first quarter of 2021 driven by COVID-19 vaccine sales and solid performance from a number of our other key growth drivers. The Adjusted cost of sales increase shown here reduced gross margin by 10 percentage points compared to the first quarter of 2020, which primarily reflects the impact of the COVID-19 vaccine gross profit split, which accounted for approximately 8 percentage points, and to a much smaller extent, product mix.
從損益表來看,收入和調整後的銷售成本受到了 COVID-19 疫苗銷售以及與 BioNTech 相關的 50% 毛利分成的重大影響,我們在銷售成本中確認了這一點。在 COVID-19 疫苗銷售和我們許多其他主要成長驅動力的穩健業績的推動下,2021 年第一季的營運收入成長了 42%。這裡顯示的調整後銷售成本增長使毛利率較 2020 年第一季下降了 10 個百分點,這主要反映了 COVID-19 疫苗毛利潤分割的影響,約佔 8 個百分點,大幅降低了毛利率。較小程度上,產品結構。
Looking at the business excluding the COVID-19 vaccine contribution, we saw a continuation of solid revenue growth for the business in the quarter, which nicely supports our projected revenue CAGR of at least 6% through the end of 2025. As a reminder, this growth projection continues to exclude any contribution from the COVID-19 vaccine.
看看不包括 COVID-19 疫苗貢獻的業務,我們看到該業務在本季度繼續保持穩健的收入成長,這很好地支持了我們預計到 2025 年底至少 6% 的收入複合年增長率。成長預測繼續排除COVID-19 疫苗的任何貢獻。
In addition, compared with the prior year quarter, first quarter 2021 revenues were favorably impacted by approximately $400 million as a result of the first quarter 2021 having 3 additional selling days in the U.S. and 4 additional selling days in international markets. This increase in selling days will be offset in fourth quarter of 2021, resulting in essentially the same number of selling days in full year '21 as compared to full year 2020.
此外,與去年同期相比,由於 2021 年第一季美國增加 3 個銷售日,國際市場增加 4 個銷售日,2021 年第一季營收受到約 4 億美元的有利影響。銷售天數的增加將在 2021 年第四季被抵消,從而導致 21 年全年的銷售天數與 2020 年全年基本相同。
However, the favorable impact on quarter-over-quarter comparisons in first quarter 2021 from selling days was partially offset by the nonrecurrence of favorable revenue impacts related to COVID-19 in first quarter 2020, including increased demand for certain products of approximately $150 million and additional wholesaler inventories of approximately $100 million. Given these factors, the net favorable impact on first quarter 2021 revenues was approximately $150 million or approximately 1.5 percentage points of operational growth, which in effect reduces the strong 8% operational growth rate to about 7%.
然而,2020 年第一季與 COVID-19 相關的有利收入影響不再出現,包括對某些產品的需求增加約 1.5 億美元和額外的批發商庫存約為 1 億美元。考慮到這些因素,對 2021 年第一季營收的淨有利影響約為 1.5 億美元,即營運成長約 1.5 個百分點,這實際上將 8% 的強勁營運成長率降低至 7% 左右。
Reported diluted EPS for the quarter was up 44% compared to the year ago quarter, while Adjusted diluted EPS grew 47% for the quarter. Foreign exchange movements resulted in a 3% positive benefit to revenue and a 1% benefit to Adjusted diluted EPS.
報告本季稀釋的每股盈餘較去年同期成長 44%,而調整後稀釋每股盈餘則成長 47%。外匯變動導致營收增加 3%,調整後攤薄每股收益增加 1%。
Let's move to our revised 2021 guidance. We've again provided total company guidance, which includes the business with the COVID-19 vaccine, and then we provided some additional sub-ledger detail on our assumptions regarding the projected COVID-19 vaccine contribution so you can also see our projection for the business without the COVID-19 vaccine.
讓我們看看修訂後的 2021 年指南。我們再次提供了整個公司的指導,其中包括 COVID-19 疫苗業務,然後我們提供了一些關於我們對預計的 COVID-19 疫苗貢獻的假設的額外分類賬詳細信息,以便您還可以看到我們對未接種COVID-19 疫苗的企業。
To start, the adjustments we've made to our total company guidance are almost entirely due to the anticipated impact of the COVID-19 vaccine and R&D spending on incremental COVID-19 programs and non-COVID-19 mRNA programs, along with a small increase in the revenue outlook for the business excluding the COVID-19 vaccine. For Adjusted cost of sales, the ranges have increased to 38% to 39%, which incorporates the incremental anticipated COVID-19 vaccine revenue which has a significantly higher cost of sales due to the gross margin split with BioNTech as compared to the rest of the business. The projected COVID-19 vaccine revenue as a percentage of total company revenue has increased to 36% as compared to 25% in our initial 2021 guidance.
首先,我們對公司整體指導方針所做的調整幾乎完全是由於 COVID-19 疫苗和研發支出對增量 COVID-19 項目和非 COVID-19 mRNA 項目的預期影響,以及小規模的影響。不包括COVID -19 疫苗的業務收入前景增加。對於調整後的銷售成本,範圍已增加至 38% 至 39%,其中包含了預期增量的 COVID-19 疫苗收入,與其他公司相比,由於與 BioNTech 的毛利率分割,其銷售成本明顯更高商業。預計 COVID-19 疫苗收入占公司總收入的百分比已增至 36%,而我們最初的 2021 年指引中為 25%。
On Adjusted SI&A, we have maintained our initial guidance of $11 billion to $12 billion. In addition, we increased our Adjusted R&D guidance range to $9.8 billion to $10.3 billion to incorporate anticipated spending on incremental COVID-19-related programs and other mRNA-based projects that are not part of the BioNTech partnership. Working this through with a projected 15% effective tax rate yields an increased Adjusted diluted EPS range of $3.55 to $3.65 or 59% growth at the midpoint compared to 2020, including an expected 4% benefit from foreign exchange.
在調整後的 SI&A 方面,我們維持了 110 億至 120 億美元的初步指引。此外,我們將調整後的研發指導範圍提高到 98 億美元至 103 億美元,以納入增量 COVID-19 相關項目和不屬於 BioNTech 合作夥伴關係的其他基於 mRNA 的項目的預期支出。透過預計15% 的有效稅率來實現這一目標,調整後稀釋每股收益範圍將擴大至3.55 美元至3.65 美元,即與2020 年相比,中間值增長59%,其中包括預計4% 的外匯收益。
Let me quickly remind you of some assumptions and context on the projected COVID-19 vaccine contribution and our collaboration agreement. As referenced earlier, the Pfizer-BioNTech COVID-19 vaccine collaboration construct is a 50-50 gross margin split. Pfizer will book the vast majority of the global collaboration revenue, except for Germany and Turkey, where we receive a profit share from BioNTech, and we do not participate in China. We now expect that we can manufacture up to 2.5 billion doses in '21, subject to continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers.
讓我快速提醒您有關預計的 COVID-19 疫苗貢獻和我們的合作協議的一些假設和背景。如前所述,輝瑞與 BioNTech COVID-19 疫苗合作結構的毛利率為 50:50。輝瑞將獲得絕大多數全球合作收入,除了德國和土耳其,我們在這兩個國家獲得 BioNTech 的利潤分成,而且我們在中國不參與。我們現在預計,透過不斷改進流程、擴大現有設施以及增加新的供應商和合約製造商,我們可以在 21 年生產多達 25 億劑疫苗。
As of mid-April, we have contracted for approximately 1.6 billion vaccine doses to be delivered in 2021 and still have contracts for potential additional doses under review. Based on the approximately 1.6 billion doses, we are now forecasting approximately $26 billion in COVID-19 vaccine revenue this year. We continue to have 3 pricing tiers for government contracts depending on the relative wealth of nations.
截至 4 月中旬,我們已簽訂了 2021 年交付約 16 億劑疫苗的合同,並且仍有潛在額外劑量的合同正在審查中。基於約 16 億劑疫苗,我們現在預測今年的 COVID-19 疫苗收入約為 260 億美元。我們繼續根據國家的相對財富水準對政府合約實施 3 個定價等級。
Our cost of sales for the COVID-19 vaccine revenue continues to include manufacturing and distribution costs, applicable royalty expense as well as a payment to BioNTech representing the 50% gross profit split. We continue to expect that the Adjusted income before tax for the COVID-19 vaccine contribution to be in the high 20s as a percentage of revenue. This margin level also includes the anticipated spending on additional mRNA programs. As I noted earlier, the COVID-19 vaccine is now projected to account for 36% of total revenue for 2021, up from 25% in our initial guidance for the year.
我們的 COVID-19 疫苗收入銷售成本繼續包括製造和分銷成本、適用的特許權使用費以及向 BioNTech 支付的相當於 50% 毛利分成的款項。我們仍然預計 COVID-19 疫苗貢獻的調整後稅前收入佔收入的百分比將在 20 多歲左右。這一利潤水平還包括額外 mRNA 項目的預期支出。正如我之前指出的,COVID-19 疫苗目前預計將佔 2021 年總收入的 36%,高於我們今年最初指引的 25%。
Let me add that if we contract for additional delivery of doses during the year, we will provide a guidance update in our subsequent earning releases. If we remove the projected COVID-19 vaccine contribution from both periods, you will see that we slightly increased 2021 revenue range to be between $44.6 billion and $46.6 billion, representing approximately 6% operational revenue growth at the midpoint.
讓我補充一下,如果我們在年內簽訂額外交付劑量的合同,我們將在後續的收益發布中提供指導更新。如果我們從這兩個時期刪除預期的COVID-19 疫苗貢獻,您會發現我們將2021 年的收入範圍略有增加,達到446 億美元至466 億美元之間,相當於中點營運收入增長約6 %。
In terms of adjusted diluted EPS, we continue to project a range of $2.50 to $2.60, which represents approximately 11% operational growth at the midpoint. These growth rates are all consistent with how we've been publicly positioning the business post the Upjohn separation.
就調整後攤薄每股收益而言,我們繼續預計範圍為 2.50 美元至 2.60 美元,這意味著中點營運成長率約為 11%。這些成長率都與我們在 Upjohn 分離後公開定位業務的方式一致。
You likely saw our announcement that we have maintained our dividend payment for the second quarter at its current level despite Viatris announcing their expected dividend payment. For those continuing to own Viatris shares, this effectively represents an increase in the dividend income, and our Board felt that the strength of our business supported maintaining our dividend. For the foreseeable future, we expect our Board to continue to support annual dividend increases at approximately this year's level. Obviously, we have no say as to what Viatris does with its future dividend.
您可能已經看到我們的公告,儘管 Viatris 宣布了預期的股息支付,但我們仍將第二季的股息支付維持在當前水平。對於那些繼續持有 Viatris 股票的人來說,這實際上代表了股息收入的增加,我們的董事會認為我們的業務實力支持維持我們的股息。在可預見的未來,我們預計董事會將繼續支持將年度股息增加到今年的水平。顯然,我們對 Viatris 如何處理未來的股息沒有發言權。
In summary, a tremendous start to 2021. The COVID-19 vaccine continues to benefit millions of people around the world, and the business is on track for anticipated solid top and bottom line growth. We remain focused on advancing our pipeline, supporting in-market brands and looking to deploy capital responsibly with a focus on initiatives that can solidify our long-term revenue and earnings growth outlook.
總之,2021 年是一個巨大的開端。COVID-19 疫苗繼續使全世界數百萬人受益,並且該業務有望實現預期的穩健營收和利潤成長。我們仍然專注於推進我們的產品線、支持市場品牌並尋求負責任地部署資本,重點關注能夠鞏固我們長期收入和獲利成長前景的舉措。
With that, I'll turn it back to Chuck.
有了這個,我會把它轉回給查克。
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
Great. Thanks, Frank and Albert, for your prepared remarks. At this point, operator, let's move to our Q&A session, please.
偉大的。感謝弗蘭克和阿爾伯特準備好的發言。現在,接線員,請讓我們進入問答環節。
Operator
Operator
(Operator Instructions) Your first question comes from the line of Louise Chen from Cantor.
(操作員說明)您的第一個問題來自 Cantor 的 Louise Chen。
Louise Alesandra Chen - Senior Research Analyst & MD
Louise Alesandra Chen - Senior Research Analyst & MD
Congratulations on the quarter. So first question I had for you. What are your thoughts on the slowing vaccination rates in the U.S.? Do you anticipate things to pick up again? And will we reach that level of herd immunity in the U.S. here? And then second question I had was on vaccine sales and how you think about it beyond 2021 and 2022. What gives you confidence that there's going to be a tail here? And how does that tail look relative to the $26 billion that you're going to potentially have this year? And then last question I had for you is just on how you're thinking about FDA concerns around JAK safety.
恭喜本季。所以我問你的第一個問題。您對美國疫苗接種率放緩有何看法?您預計情況會再次好轉嗎?我們能在美國達到群體免疫的程度嗎?我的第二個問題是關於疫苗銷售,以及您如何看待 2021 年和 2022 年之後的情況。是什麼讓您相信這裡會出現尾巴?相對於今年可能擁有的 260 億美元,這條尾巴看起來如何?我問您的最後一個問題是您如何看待 FDA 對 JAK 安全性的擔憂。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much, Louise. Let me make some comments on the slowing vaccinations and maybe a little bit on the '22, '23 revenues. I will ask Mikael Dolsten to add some comments over there. And then for also JAK, I will ask him to make some comments about the same. Look, I think the U.S. has done a tremendously good job and they have reached vaccination level that we didn't think that they will. The truth is that as we are vaccinating more and more people, the people that are reluctant to get a vaccine are enriching the remaining pool. So it's normal to expect that we will see a drop in the vaccination.
非常感謝你,路易絲。讓我對疫苗接種放緩以及 22、23 年收入發表一些評論。我會請 Mikael Dolsten 在那裡添加一些評論。然後對於 JAK,我也會請他對此發表一些評論。看,我認為美國做得非常好,他們已經達到了我們認為不會達到的疫苗接種水平。事實是,隨著我們為越來越多的人接種疫苗,那些不願意接種疫苗的人正在豐富剩餘的人。因此,預計疫苗接種量會下降是正常的。
But I believe that the entering of additional pools like younger people post the expected approval of our [12] (corrected by company after the call) to 15 years old, vaccination also will provide an additional increase in the vaccination rates. All in all, I think U.S. is doing a very good job and their focus of all should be to convince those people that they have still fear about the vaccine that they must do the right thing.
但我相信,像年輕人這樣的額外群體的進入將我們[12](電話後由公司更正)的預期批准推遲到15歲,疫苗接種也將進一步提高疫苗接種率。總而言之,我認為美國做得非常好,他們的重點應該是讓那些仍然對疫苗感到恐懼的人相信他們必須做正確的事情。
Now beyond '22 and '23, first of all, we believe, as we said multiple times, that there will be a need for boosters. And there is a need likely from now all the way to 6 months and then believe that likely annual vaccinations or, let's say, regular vaccinations would be required. Clearly, this belief is based on the totality of the evidence and not on studies that they had read out right now to convince that this is the case.
現在,在「22」和「23」之後,首先,正如我們多次所說,我們相信將需要助推器。可能需要從現在一直到 6 個月,然後相信可能需要每年接種一次疫苗,或說需要定期接種疫苗。顯然,這種信念是基於全部證據,而不是基於他們現在宣讀的研究來證明情況確實如此。
The totality of the evidence are having to do with the fact that we still have very high efficacy of 90%, above 90% in our 6 months, but it is lower at 91% than 95% that we had in the beginning. So there are some indications that there is a drop in the efficacy over time. We know from immunogenicity studies of neutralizing antibodies that also there is a drop on these antibodies, and that affects not only people that they are vaccinated but also naturally infected.
證據的整體性與這樣一個事實有關:我們仍然具有 90% 的高功效,在 6 個月內高於 90%,但低於我們開始時的 95%,為 91%。因此,有一些跡象表明,隨著時間的推移,療效會下降。我們從中和抗體的免疫原性研究中得知,這些抗體也會下降,這不僅會影響接種疫苗的人,也會影響自然感染的人。
We also know that after 6 months, the increase of reinfections to people that they had previous infections is increasing. And we also know that we are, right now, our vaccine at least effective against all the variants that we have seen but there is a drop in neutralizing titers, which means that to maintain good efficacy against the variants, you need to increase the immunogenicity and this is why we are doing the studies with the boosters.
我們也知道,6個月後,以前感染過的人再次感染的人數正在增加。我們也知道,目前我們的疫苗至少對我們所見過的所有變體都有效,但中和滴度有所下降,這意味著要保持對變體的良好功效,您需要提高免疫原性這就是我們使用助推器進行研究的原因。
So the totality of the events are pointing out to this. And this is the reason why basically all governments of the world are now discussing with us about procurement agreements for '22, '23 and '24. But I will ask also Mikael Dolsten to make some comments on why we think that the boosters and repeated vaccinations is a likely scenario and also a comment on the JAK safety. Mikael?
因此,所有事件都表明了這一點。這就是為什麼基本上世界上所有政府現在都在與我們討論「22」、「23」和「24」採購協議的原因。但我也會請 Mikael Dolsten 就為什麼我們認為加強疫苗接種和重複疫苗接種是一種可能的情況發表一些評論,並對 JAK 安全性發表評論。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. Thank you, Albert. I thought you outlined, in an excellent manner, that we have identified a handful of key point related to immunity when induced by convalescent after infection of vaccine that will, over time, as expected, show some decline. Antibodies will show some decline as their half-life are limited. Of course, protection contains other immune mechanism.
是的。謝謝你,艾伯特。我認為您以出色的方式概述了我們已經確定了一些與疫苗感染後恢復期誘導的免疫力相關的關鍵點,隨著時間的推移,正如預期的那樣,免疫力會出現一些下降。由於半衰期有限,抗體會出現一些下降。當然,保護也包含其他免疫機制。
When you put all of this in context that SARS-CoV-2 is globally circulating to extent we have rarely seen or ever seen in our lifetime of a virus, and the inability to control across the globe will, of course, lead to numerous changes in the viral mutation rate. So it just punctuates what Albert said, we need continuously to keep up a very high immune pressure against the virus to stay ahead of the curve. And the best way to do that is with regular boosting.
當你把所有這些放在這樣的背景下時,SARS-CoV-2 在全球範圍內傳播的程度是我們在病毒的一生中很少看到或從未見過的,而無法在全球範圍內控制當然會導致許多變化在病毒突變率方面。因此,這正好強調了阿爾伯特所說的,我們需要不斷保持針對病毒的非常高的免疫壓力,以保持領先地位。做到這一點的最佳方法是定期增強。
And finally, herd immunity, while we would like to see it establish, what you hear from a lot of public health data and global health data emerging is that it will be really difficult in large continent to establish such a high immunization rate across all ages and to ensure as you immunize one part of the continent that immunity is maintained at another part. So I think we would really need to rely on regular immunization and of course, other public health measures rather than hoping that herd immunity across the globe can be established.
最後,群體免疫,雖然我們希望看到它建立,但你從大量公共衛生數據和全球健康數據中聽到的是,在廣闊的大陸上要在所有年齡段建立如此高的免疫率確實很困難並確保當您對非洲大陸的一個地區進行免疫時,另一個地區也能保持免疫力。因此,我認為我們確實需要依靠定期免疫,當然還有其他公共衛生措施,而不是希望能夠在全球範圍內建立群體免疫。
Finally, on the JAK safety, already in February 21, FDA made it public about our data in 1133 related to increased risk of serious heart-related problems and certain cancer when compared to another type of medicines, the TNF inhibitors. So these data are clearly not new. FDA, EMA and other agencies work in dialogue with us to finalize the outcome of this review. On the other hand, I think the JAK class has shown to be an important contribution as an oral alternative for many patients, and you avoid other issues such as drug antibodies with the biologicals.
最後,關於 JAK 的安全性,FDA 早在 2 月 21 日就公開了我們 1133 的數據,這些數據與另一種藥物 TNF 抑制劑相比,會增加嚴重心臟相關問題和某些癌症的風險。所以這些數據顯然並不新鮮。 FDA、EMA 和其他機構與我們進行對話,以最終確定本次審查的結果。另一方面,我認為 JAK 類藥物已被證明是許多患者的口服替代品的重要貢獻,並且可以避免其他問題,例如生物製劑的藥物抗體。
So we continue to wait for finalization of the outcome of the 1133 trial. We think each JAK inhibitor is unique and need to be assessed by itself. And we continue to believe that with proper labeling and given the tremendous experience of Xeljanz since 2012, it will continue to have a potential to be an important medicine.
所以我們繼續等待1133審判結果的最終確定。我們認為每種 JAK 抑制劑都是獨特的,需要單獨評估。我們仍然相信,透過適當的標籤以及 Xeljanz 自 2012 年以來的豐富經驗,它將繼續有潛力成為一種重要的藥物。
Operator
Operator
Your next question comes from Terence Flynn from Goldman Sachs.
您的下一個問題來自高盛的特倫斯·弗林。
Terence C. Flynn - MD
Terence C. Flynn - MD
Thank you for all the work on the vaccine front. I just had a follow-up on the booster question. Do you think that will be uniform across different groups or will there be any differences by baseline characteristics such as age in terms of the timing of a need for a boost? And then would you expect FDA and CDC to issue a recommendation on the need for boosters sometime this year? And then my second question for Albert or Frank is just would welcome your perspective on the potential impact of tax rate changes in the U.S. and any thoughts on how that might change your capital allocation strategy and/or views on inversions.
感謝您在疫苗方面所做的所有工作。我剛剛對助推器問題進行了跟進。您認為不同群體之間的情況是否一致,或者在需要加強治療的時間方面,年齡等基線特徵是否會存在差異?那麼您是否期望 FDA 和 CDC 在今年某個時候發布關於需要加強劑的建議?然後,我向阿爾伯特或弗蘭克提出的第二個問題是歡迎您對美國稅率變化的潛在影響的看法,以及關於這可能如何改變您的資本配置策略和/或對倒置的看法的任何想法。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Mikael, why don't you take the question for the boosters?
米凱爾,為什麼不回答助推器的問題呢?
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. I think we cannot, of course, predict what CDC and similar agencies will do. But what seems to be the general public dialogue and which, of course, builds on experience with other viral epidemics, and this is, of course, a pandemic, is that you would likely start with those that are most susceptible, older adults, those with chronic diseases such as cardiovascular, obesity, COPD, asthma, many that are immune-impaired. And of course, that constitutes a very large population.
是的。當然,我認為我們無法預測疾病預防控制中心和類似機構會做什麼。但是,似乎是普遍的公眾對話,當然,這是建立在其他病毒流行病的經驗基礎上的,這當然是一場大流行病,你可能會從那些最易受影響的人、老年人、那些患有心血管、肥胖、慢性阻塞性肺病、氣喘等慢性疾病,其中許多疾病都是免疫受損的。當然,這構成了一個非常大的人口。
While you may start with those, if we are to really maintain control of the virus, it will be very reasonable to assume the importance of also vaccinating younger groups. Although severe COVID is less common in younger groups, some patients may suffer severely from such infection, and they are at risk also of acquiring long COVID syndrome, which can cause significant impairment of participation in functional life for young individuals as well as old. So all in all, yes, regular boost of entire population is a clear possibility. Priority is to start, of course, with the many vulnerable from age to chronic diseases, which is a large number of adult population.
雖然您可能會從這些開始,但如果我們要真正保持對病毒的控制,那麼假設年輕群體也接種疫苗的重要性將是非常合理的。儘管嚴重的新冠肺炎在年輕族群中較少見,但有些患者可能會遭受嚴重的感染,而且他們還有長期新冠肺炎症候群的風險,這可能會嚴重損害年輕人和老年人的功能生活參與。總而言之,是的,定期增加整個人口數量顯然是可能的。當然,首要任務是從許多易患慢性病的人群開始,其中包括大量的成年人口。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Mikael. And Frank, would you like to take the question about the tax?
謝謝你,米凱爾。弗蘭克,您想回答有關稅收的問題嗎?
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Sure. Thank you, Albert. So I think it's premature to comment on what impact the proposed tax reform would have in how we view capital allocation and inversion simply because these kinds of proposals typically go through multiple iterations, multiple discussions, multiple negotiations. Obviously, we're staying very close to this, doing all the analytics that you would expect us to do.
當然。謝謝你,艾伯特。因此,我認為現在評論擬議的稅收改革會對我們如何看待資本配置和倒置產生什麼影響還為時過早,因為此類提案通常會經過多次迭代、多次討論、多次談判。顯然,我們非常接近這個目標,並做了您期望我們做的所有分析。
But I think what's really important is how we think about taxes and tax policy. 2017 tax reform leveled the playing field for U.S. multinationals against foreign competitors. And that was an enabler, from my perspective, of much of what we've done with capital deployment, particularly in the U.S. We committed to $5 billion of CapEx investment between 2018 and 2022. We committed a few billion of that risk capital in order to develop the COVID vaccine, funding of our U.S. qualified pension plan that we did last year to the tune of over $1 billion.
但我認為真正重要的是我們如何看待稅收和稅收政策。 2017 年的稅制改革為美國跨國企業與外國競爭對手提供了公平的競爭環境。從我的角度來看,這是我們在資本部署方面所做的大部分工作的推動者,特別是在美國。我們承諾在2018 年至2022 年間進行50 億美元的資本支出投資。我們承諾了數十億美元的風險資本,以便為了開發新冠病毒疫苗,我們為去年實施的美國合格退休金計劃提供了超過 10 億美元的資金。
All of those, from my perspective, were enabled by the level playing field that we now get to compete on against our foreign competitors. So what we want from tax reform, when all is said and done, is we want that level playing field to continue so that we have the ability to compete on a level playing field. So that's my answer, Albert.
從我的角度來看,所有這些都是由於我們現在能夠與外國競爭對手競爭的公平競爭環境而實現的。因此,歸根結底,我們對稅改的期望是,我們希望公平的競爭環境能持續下去,以便我們有能力在公平的競爭環境中競爭。這就是我的回答,艾伯特。
Operator
Operator
Your next question comes from Geoffrey Porges from SVB Leerink.
您的下一個問題來自 SVB Leerink 的 Geoffrey Porges。
Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst
Geoffrey Craig Porges - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst
Congratulations on a remarkable quarter and really tremendous progress. Some quick questions. First on pricing, you mentioned the 5% price headwind. Could you give us a sense of what that looks like for the rest of the year? Is that something that we should be expecting for the full year or is it just a Q1 phenomenon? And then related to that, Albert, you disclosed your view on the pricing policy and regulatory and legislative update. But is what you described a realistic case or is that the best case?
恭喜您取得了非凡的季度業績和巨大的進步。一些簡單的問題。首先在定價方面,您提到了 5% 的價格逆風。您能為我們介紹一下今年剩餘時間的情況嗎?這是我們全年都應該期待的事情還是只是第一季的現象?與此相關的是,阿爾伯特,您透露了您對定價政策以及監管和立法更新的看法。但你所描述的是現實情況還是最好的情況?
And then a couple of questions for Mikael. Mikael, I've asked you this before, but given what we're seeing in India and in other geographies, is it your view that COVID is going to be a case of convergent evolution or continuous evolution, i.e., are we seeing new mutations beyond E484K that have additional resistance mechanisms to the first generation of vaccines and antibodies? And then just lastly, you mentioned mRNA. You have a maternal RSV vaccine. Are you planning to apply mRNA as a more efficient approach to getting neonatal and infant coverage against RSV?
然後問米凱爾幾個問題。邁克爾,我以前問過你這個問題,但考慮到我們在印度和其他地區看到的情況,你認為新冠病毒將是趨同進化還是持續進化的情況,即我們是否會看到新的突變除了E484K之外,還有哪些對第一代疫苗和抗體有額外的抗藥性機制?最後,你提到了 mRNA。您接種了孕婦 RSV 疫苗。您是否計劃應用 mRNA 作為更有效的方法來獲得新生兒和嬰兒的 RSV 覆蓋?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Geoff, a lot of questions, very important. Now let me speak a little bit about the policy of the prices, and then I will ask Frank to comment a little bit on the pricing. And if Angela needs to add something, please feel free. And then on the 2 other areas, clearly, Mikael will speak about the resistance and the mRNA.
謝謝傑夫,有很多問題,非常重要。現在讓我談談價格政策,然後我將請弗蘭克對定價發表一些評論。如果安吉拉需要添加一些內容,請隨意。然後在其他 2 個領域,顯然,Mikael 將談論阻力和 mRNA。
On the pricing reforms, these are our standard positions. But I will try to explain how I feel about the pricing reforms. And I have said it in multiple occasions. We don't think that status quo is good for anyone. I don't think it's good for the industry. I don't think it's good for the Americans because there is a problem with the current way, the current system. And this is a problem that basically every American is paying for their medicines, and this is unique to medicines, not to other medical interventions, is paying out of their pocket like if they don't have insurance, although they do have insurance.
關於價格改革,這是我們的標準立場。但我會試著解釋一下我對定價改革的看法。我已經在多個場合說過了。我們認為現狀對任何人都沒有好處。我不認為這對這個行業有好處。我認為這對美國人沒有好處,因為現行的方式、現行的製度有問題。這是一個基本上每個美國人都在支付藥品費用的問題,這是藥品所特有的,而不是其他醫療幹預措施,就像他們沒有保險一樣自掏腰包,儘管他們有保險。
And this is the fundamental thing that needs to change because the medicines contribution to the overall health care, it is 12%. So by definition, cannot be the big issue but it is becoming the big issue in the discussion because everybody has to pay this thing from out of pocket almost, unlike other intervention. So what this change could look like? And for us, a change could take different forms. It could be consistent from different areas, may not be the rebate reform, which I think it is one of the systemic issues that we are having with drug pricing, but it could be that out-of-pocket caps.
這是需要改變的根本問題,因為藥物對整體醫療保健的貢獻為 12%。因此,根據定義,這不可能是大問題,但它正在成為討論中的大問題,因為與其他幹預措施不同,每個人幾乎都必須自掏腰包支付這筆費用。那麼這種變化會是什麼樣子呢?對我們來說,改變可以採取不同的形式。不同領域的情況可能是一致的,可能不是回扣改革,我認為這是我們在藥品定價方面遇到的系統性問題之一,但也可能是自付費用上限。
The fundamental thing is that there will be a cost that the industry, I'm sure, will be willing to take our fair share as long as all the savings, all the contributions that we are doing right now from this industry will go to the pockets of the American patients. And this is a fundamental difference with people that we're discussing right now because we are hearing a lot of suggestions that they want to tax the pharmaceutical companies or tax the insurance companies, but the proceeds will just fall in the black hole of the federal budget, which is not what we want.
最根本的是,我確信,只要所有的節省、我們現在從這個行業所做的所有貢獻都將流向這個行業,這個行業就會願意承擔我們公平的份額。美國病人的口袋。這與我們現在正在討論的人有一個根本的區別,因為我們聽到很多建議,他們想對製藥公司徵稅或對保險公司徵稅,但收益只會落入聯邦的黑洞。預算,這不是我們想要的。
If our contributions go to the patients, we are sitting down with all the parties trying to do a decent price reform in the way that the Americans are experiencing the cost when they go to their pharmacy to collect their medicines. So is it realistic or optimistic? I believe it is realistic. I believe that there is room for agreement both with the 2 sides of the aisle and with this administration. And we will continue working on finding the solution that will, I repeat, make medicines affordable for the patients and not throw money to the black hole of the federal budget. Now Frank, if you can take the price increase and then Mikael.
如果我們的捐款捐給了患者,我們就會與各方坐下來,努力進行體面的價格改革,就像美國人去藥房取藥時所經歷的費用一樣。那麼這是現實的還是樂觀的呢?我相信這是現實的。我相信兩黨和本屆政府都有達成一致的空間。我再說一遍,我們將繼續努力尋找解決方案,讓病人負擔得起藥品,而不是把錢投入聯邦預算的黑洞。現在弗蘭克,如果你能接受價格上漲,然後是米凱爾。
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Okay. So you've heard Albert and me talk about pricing and that pricing has been a headwind, and we expect it to continue to be a headwind for the foreseeable future. And that's obviously what we saw this quarter with pricing being a negative 5% on a global basis. I should also mention it was negative 5% in the U.S. Now in terms of our guidance, which is what you asked, Geoffrey, our guidance assumed the pricing decrease, negative impact, I'll call it in the range of low to mid-single digits. So that 5% reduction that we saw this quarter is consistent with what we assumed in our annual guidance.
好的。所以你已經聽過阿爾伯特和我談論定價,定價一直是一個阻力,我們預計它在可預見的未來將繼續是一個阻力。顯然,這就是我們本季看到的情況,全球範圍內的定價負 5%。我還應該提到的是,在美國,這是負5%。現在就我們的指導而言,這就是你所問的,傑弗裡,我們的指導假設價格下降,負面影響,我將其稱為為低到中的範圍 -個位數。因此,我們本季看到的 5% 的減少與我們在年度指導中的假設一致。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Frank. And by the way, I wanted to add that this minus 5% that it is the reality of the numbers. I'm sure that many Americans haven't experienced during this quarter a 5% reduction in their out of pocket because it's a system that works in a way that no matter what you do on the top, the price that they have to pay is derived from very different rules. Mikael, can you speak a little bit about the resistance mechanism in the mRNA or RSV?
謝謝你,弗蘭克。順便說一句,我想補充一點,負 5% 是數字的真實情況。我確信許多美國人在本季度並沒有經歷過自付費用減少 5%,因為這個系統的運作方式是,無論你在高層做什麼,他們必須付出的代價是源自非常不同的規則。 Mikael,您能談談 mRNA 或 RSV 中的抗藥性機制嗎?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes, thank you. I'll start with mRNA. As you discussed here, Geoffrey, of course, there is tremendous viral amount across the globe fueled by the spread in large population areas like India. We do see several different lineages of SARS-CoV-2 established. They, however, seem to share the most critical mutations. Most of the variants have up to 10 mutations and they can combine from different ways.
是的,謝謝。我將從 mRNA 開始。當然,正如您在這裡討論的那樣,傑弗裡,由於印度等人口眾多的地區的傳播,全球範圍內病毒數量巨大。我們確實看到了 SARS-CoV-2 的幾種不同譜系的建立。然而,它們似乎共享最關鍵的突變。大多數變體有多達 10 個突變,並且它們可以透過不同的方式組合。
So far, we believe that our B2, the current vaccine, is very effective in controlling all known mutations. But as Albert alluded to, we believe it's very important to keep up very high neutralizing antibody levels in addition to the nice T cell immunity. And that's why a possible outcome of this tremendous spread, including India, is to have a regular boost.
到目前為止,我們相信我們的 B2(目前的疫苗)在控制所有已知突變方面非常有效。但正如 Albert 所提到的,我們認為除了良好的 T 細胞免疫力之外,保持非常高的中和抗體水平也非常重要。這就是為什麼包括印度在內的這種巨大傳播的可能結果是定期推動。
As the pandemic continue, up to now, mutations have been selected mainly because the virus is trying to spread more quickly. The virus will now face vaccinated immunity in maybe '22, '23 increasingly. So we need to be prepared that there could be new unexpected mutations to come. And that's why Pfizer is leaving no stone untouched and also have variant vaccine developed and could be an alternative later if that scenario would emerge. But right now, it seems like the current vaccine is very effective against all these variants despite each having up to 10 different mutations.
隨著大流行的持續,到目前為止,選擇突變主要是因為病毒試圖更快地傳播。該病毒現在可能會在「22」、「23」期間越來越多地面臨疫苗免疫。因此,我們需要做好準備,可能會出現新的意想不到的突變。這就是為什麼輝瑞不遺餘力地開發了變異疫苗,如果發生這種情況,可能會成為以後的替代方案。但目前看來,目前的疫苗對所有這些變種都非常有效,儘管每種變種都有多達 10 種不同的突變。
On the RSV, well, we had very robust titers with our protein-based RSV vaccine in maternal vaccination, very good tolerability and antibodies passed efficiently through the cord blood. And we are enrolling now well in Phase 3. We also have initiated a Phase 2 challenge study with RSV that will read out mid of the year, and that could possibly lead to progression swiftly into Phase 3. So we are pretty advanced with the protein-based, looks very good. But of course, we have now an mRNA platform that we would like to use for multiple opportunities. We expect to put into the clinic 2 first in humans novel vaccines every year for the next 2 years. Certainly, RSV could, in the future, be one alternative, whether it could be as a supplement to the protein-based in order to add some T cell immunity. These are things we'll continue to explore and then prioritize among the many exciting opportunities for our mRNA platform.
在 RSV 方面,我們基於蛋白質的 RSV 疫苗在孕產婦疫苗接種中具有非常強的滴度,具有非常好的耐受性,並且抗體可以有效地通過臍帶血。我們現在正在順利進入第 3 階段。我們還啟動了 RSV 的第 2 階段挑戰研究,該研究將於今年年中公佈,這可能會導致迅速進入第 3 階段。所以我們在蛋白質方面已經相當先進基於,看起來非常好。當然,我們現在擁有一個 mRNA 平台,我們希望利用它來獲得多種機會。我們預計未來 2 年內每年都會將 2 種新型疫苗投入臨床。當然,RSV 在未來可能是一種替代方案,無論它是否可以作為基於蛋白質的補充,以增加一些 T 細胞免疫力。這些是我們將繼續探索的事情,然後在我們的 mRNA 平台的許多令人興奮的機會中優先考慮。
Operator
Operator
Your next question comes from Steve Scala from Cowen.
您的下一個問題來自 Cowen 的 Steve Scala。
Stephen Michael Scala - MD & Senior Research Analyst
Stephen Michael Scala - MD & Senior Research Analyst
I have 2 questions. Regarding the DMD gene therapy, is the potency assay issue related to concerns around correlation of biomarkers to motor function efficacy or is it simply a technical issue with no bearing on relevance of the endpoints? And second question is a little bit more broad-based. But in the COVID vaccine, Pfizer has built the world's largest global pharmaceutical franchise in 6 months. I imagine that it is creating a substantial stress throughout the organization, similar to the disruption of a major acquisition. What metrics do you monitor to ensure that these stresses are not going to show up in 1 to 3 years or so as, say, subpar product performances, clinical trial failures that otherwise would have been successes and maybe missed M&A that would have otherwise made sense for Pfizer?
我有 2 個問題。關於 DMD 基因治療,效力測定問題是否與生物標記與運動功能功效相關性的擔憂有關,或者這只是一個與終點相關性無關的技術問題?第二個問題的範圍更廣一些。但在新冠疫苗方面,輝瑞在 6 個月內建立了全球最大的製藥特許經營權。我想這會給整個組織帶來巨大的壓力,類似於重大收購的破壞。您監控哪些指標來確保這些壓力不會在 1 到 3 年內出現,例如產品性能不佳、原本會成功的臨床試驗失敗,以及可能會錯過原本有意義的併購輝瑞公司?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much, Steve. Mikael, would you like to take the DMD question? Is it a technical issue? What is the issue there?
非常感謝你,史蒂夫。 Mikael,您願意回答 DMD 問題嗎?是技術問題嗎?那裡有什麼問題?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes. So the DMD trial, first of all, and I think Albert mentioned that in his introductory remark, is enrolling in many different countries. And in each of those, we had a matrix of assays that were cleared by the regulatory authorities. The particular discussion with FDA is more of a technical issue on how to do a quantification in one supportive assay but not really as per our view in any of the main assays. So we continue to work with them and aim to resolve it. I want to point out that to the best of my knowledge, we were first to start DMD Phase 3, now enrolling well outside the U.S. late last year. And we are probably by now entering May, 6 months ahead of anyone using gene therapy as it's at least public. It hasn't been disclosed any other having been cleared with FDA.
是的。因此,首先,我認為阿爾伯特在他的介紹性發言中提到了 DMD 試驗,正在許多不同的國家進行招募。在每一項中,我們都有一個經過監管機構批准的檢測矩陣。與 FDA 的具體討論更多的是關於如何在一項支持性測定中進行量化的技術問題,但實際上並不符合我們在任何主要測定中的觀點。因此,我們將繼續與他們合作並致力於解決這個問題。我想指出的是,據我所知,我們是第一個啟動 DMD 第 3 階段的公司,目前已於去年年底在美國以外地區進行註冊。我們現在可能已經進入 5 月,比任何使用基因療法的人都早 6 個月,因為它至少是公開的。目前尚未透露任何其他產品已獲得 FDA 批准。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Mikael. And Steve, it's true that in order to achieve what was achieved with this vaccine, the ingenuity of our people was a key component but also a lot of personal sacrifice had to be involved. So a lot of the people worked day and night, a lot of these people worked days and nights to make sure that this happened. And that clearly, it is taking a toll on them. And no matter how proud they feel because the passion that they have can keep them going forever, I am concerned that we need to find ways so that these people will not be burned out.
謝謝你,米凱爾。史蒂夫,確實,為了實現這種疫苗所取得的成果,我們人民的聰明才智是一個關鍵組成部分,但也必須付出大量的個人犧牲。所以很多人日夜工作,很多人日夜工作確保這一切發生。很明顯,這對他們造成了損失。無論他們感到多麼自豪,因為他們所擁有的熱情可以讓他們永遠前進,我擔心我們需要找到方法,讓這些人不會被倦怠。
But then I need also to emphasize that Pfizer is run in the form of business units. Since 2016, when I was running the business that basically Angela is running right now and to have organized the whole operations into 6 business units. And that involved the R&D, the commercial and the clinical development. So the work for COVID happened in 1 of the 6 business units and happened predominantly in the R&D domain of these clinical units. But at the same time, the Oncology business unit and the Rare Disease business unit and the Internal Medicine business unit and all the other business units that we are having kept working on their normal, let's say, workload, let me put it that way.
但我還需要強調,輝瑞是以業務部門的形式運作的。自 2016 年以來,我負責營運基本上是 Angela 現在正在運營的業務,並將整個營運組織為 6 個業務部門。這涉及研發、商業和臨床開發。因此,針對新冠肺炎的工作發生在 6 個業務部門中的 1 個,並且主要發生在這些臨床部門的研發領域。但同時,腫瘤業務部門、罕見疾病業務部門、內科業務部門以及我們正在繼續正常工作的所有其他業務部門,讓我這麼說吧,工作量。
They had, of course, also to overcome issues related with the COVID-19 that didn't make their work very easy. But again, they were able to rise to the occasion because I believe everybody in Pfizer right now is so strong believer of the culture that patients come first. And this is not about us, it's about them. So this sense of sacrifice that we see in the vaccines, we have seen it also in the other units. People are very passionate about what they do and they feel very proud.
當然,他們還必須克服與 COVID-19 相關的問題,這讓他們的工作變得非常困難。但同樣,他們能夠挺身而出,因為我相信輝瑞現在的每個人都堅信病人至上的文化。這不是關於我們,而是關於他們。因此,我們在疫苗中看到的這種犧牲感,我們也在其他單位中看到了。人們對自己所做的事情充滿熱情,並且感到非常自豪。
So I'm giving the answer to say that there is a very intense, let's say, disruption that happened in part of the organization, not in the entire organization, but has been offset by an incredible sense of pride that those people are taking because of what has been achieved. So I can't control them in terms of how hard they are working right now on all the other vaccines, for example.
所以我給的答案是,比方說,在組織的一部分而不是整個組織中發生了非常強烈的破壞,但這些破壞被這些人所承受的令人難以置信的自豪感所抵消,因為已取得的成就。因此,例如,我無法控制他們現在在所有其他疫苗上的努力程度。
Operator
Operator
Your next question comes from Vamil Divan from Mizuho Securities.
您的下一個問題來自瑞穗證券的 Vamil Divan。
Vamil Kishore Divan - MD
Vamil Kishore Divan - MD
So a couple of questions that I have. So one, I guess there's obviously been some debate around the durability of your vaccine sales and cash flows. But you clearly have a lot more sales and a lot more free cash now to potentially invest than you've probably envisioned a couple of years ago because of the vaccine. So I'm just thinking that you are obviously investing more behind the COVID vaccine and therapeutics. But can you just talk about your priorities from a capital allocation perspective? Now I don't think you mentioned you don't want to do share repurchases. But is there other priorities that you could maybe look to, whether it's bringing in external assets or maybe even doing larger deals given the extra cash that you now will have?
我有幾個問題。因此,我想顯然圍繞著疫苗銷售和現金流的持久性存在一些爭論。但由於疫苗的出現,你現在的銷售額和自由現金顯然比你幾年前想像的要多得多,可供潛在投資。所以我只是認為你們顯然在新冠疫苗和治療方面投入了更多資金。但您能從資本配置的角度談談您的優先事項嗎?現在我認為你沒有提到你不想進行股票回購。但是,您是否可以考慮其他優先事項,無論是引入外部資產,還是考慮到您現在擁有的額外現金,甚至可能進行更大的交易?
And then maybe a second one, I guess, for Albert, maybe a little bit more of a personal angle here. But I appreciate the comments you made around the COVID crisis in India recently. I'm just wondering if you can provide some clarity on the status of getting your vaccine to the market there. I think you filed back in February and then there's some questions on maybe doing a trial in India, I think some questions around indemnification around side effects. Can you just clarify where things stand there and what might be reasonable in terms of timing to get the vaccine available to patients there?
我想,對艾伯特來說,也許還有第二個,也許更多的是個人角度。但我很欣賞你最近對印度新冠危機發表的評論。我只是想知道您是否可以澄清一下將疫苗推向市場的情況。我想你在二月提交了申請,然後有一些關於可能在印度進行試驗的問題,我認為一些關於副作用賠償的問題。您能否澄清一下目前的情況以及向那裡的患者提供疫苗的合理時機?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. Thank you very much. Let me start with that. In terms of the vaccine in India, we applied months ago, as you know. And we applied exactly the same file that we gave to the entire world, FDA, EMA, Japan, everybody in the world. India wanted to do additional studies in order to approve this vaccine over there, which clearly, we were not ready to allocate resources doing something like that when we were allocating all the resources to do things into the variants, the kids, pregnant women and I can go on, things that we haven't done it before.
是的。非常感謝。讓我從那開始。至於印度的疫苗,如你所知,我們幾個月前就申請了。我們應用了與向全世界、FDA、EMA、日本以及世界上每個人提供的完全相同的文件。印度想要做更多的研究,以便在那裡批准這種疫苗,很明顯,當我們分配所有資源來對變體、兒童、孕婦和我做事情時,我們還沒有準備好分配資源來做類似的事情。可以繼續,我們以前沒有做過的事。
But the Indian government's really very good in having discussions right now with us about all these issues that you have raised. So we are hopeful that they would change this policy about conducting some local trials, and we will find a path forward so that we can provide the vaccines. That being said, the key thing right now today in the next 1 or 2 months, it is that people are dying in hospitals in India, and vaccine will not change that in the next 1 or 2 months. I think that will be a reality that we have to live with right now.
但印度政府現在確實非常願意與我們就你提出的所有這些問題進行討論。因此,我們希望他們能夠改變進行一些本地試驗的政策,我們將找到一條前進的道路,以便我們能夠提供疫苗。話雖如此,未來一兩個月內最關鍵的事情是,印度醫院裡的人們正在死亡,疫苗不會在未來一兩個月內改變這一點。我認為這將是我們現在必須面對的現實。
And what is more important is to make sure that the Indian government has enough medicines to treat the people that are going to the hospitals right now. And this is why I guess that we announced that for 4 of our medicines that they are in their governmental protocol because the authorities have developed a protocol of treating COVID patients. And there are 4 of our medicines involved in these protocols. We will provide enough of these medicines for every patient in every public hospital in the next 30 days. And as we speak, we are ramping up production of these medicines in Europe, in the U.S., in Asia. And we are ramping up distribution channels so that we can ship as quickly as possible those medicines to India because the need is immediate.
更重要的是確保印度政府有足夠的藥物來治療現在要去醫院的人。這就是為什麼我想我們宣布我們的 4 種藥物已納入政府方案,因為當局已經制定了治療新冠患者的方案。這些協議涉及我們的 4 種藥物。我們將在未來30天內為每家公立醫院的每位患者提供足夠的這些藥物。正如我們所說,我們正在歐洲、美國和亞洲增加這些藥物的生產。我們正在擴大分銷管道,以便我們能夠盡快將這些藥品運送到印度,因為印度的需求是迫切的。
Now on the capital allocation, I will ask also Frank to make some comments here, but very few things are changing because of that. Our strategy on capital allocation was not driven with how much capital we have, was driven with how much opportunity we have. So we never say never to anything. So we maintain the right to be flexible. But clearly, Frank spoke about it, a growing dividend, it is a part of our investment thesis, so that will be maintained. And also, we said that our investment in research, our investment in manufacturing, our investments of our capital are all aiming to improve the longevity, how durable it is our growth in the second part of the decade. So you should expect to see a lot of Phase 2, Phase 3 business development deals that will allow us to bring in-house a lot of potential medicines that could become medicines in this time frame. Frank, anything to add?
現在關於資本配置,我也會請弗蘭克在這裡發表一些評論,但很少事情會因此而改變。我們的資本配置策略不是由我們擁有多少資本所驅動的,而是由我們擁有多少機會所驅動的。所以我們永遠不會對任何事說永遠。所以我們保留彈性的權利。但顯然,弗蘭克談到了這一點,即不斷增長的股息,這是我們投資理論的一部分,因此將得到維持。此外,我們也說過,我們對研究的投資、對製造業的投資、對資本的投資都是為了延長壽命,提高我們在這十年後半段的成長的持久性。因此,您應該期望看到大量第二階段、第三階段業務開發交易,這些交易將使我們能夠在內部引入許多可能在這段時間內成為藥物的潛在藥物。弗蘭克,有什麼要補充的嗎?
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Yes, Vamil, you're absolutely right. Obviously, the COVID business is generating incremental free cash flow for us, but from my perspective, not material enough to have any major impact on our capital structure. And to Albert's point, the term I would use is, we will stay the course in terms of how we deploy our capital. And then Albert obviously mentioned the areas where we would deploy it, right? The dividend, investing in the business and you saw that with the R&D guidance increase this quarter and then M&A and M&A really focused on growth in the second half of the decade.
是的,瓦米爾,你說得完全正確。顯然,新冠疫情業務正在為我們產生增量的自由現金流,但從我的角度來看,還不足以對我們的資本結構產生任何重大影響。對於阿爾伯特的觀點,我使用的術語是,我們將堅持我們如何部署資本的方針。然後阿爾伯特顯然提到了我們將部署它的區域,對吧?股利、對業務的投資,你會看到,隨著本季研發指引的增加,然後併購和併購真正集中在這十年後半段的成長。
Operator
Operator
Your next question comes from Umer Raffat from Evercore ISI.
您的下一個問題來自 Evercore ISI 的 Umer Raffat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Frank, there was a comment you made back in March which got a lot of attention. And I thought perhaps you could elaborate a bit more on how you're thinking about the durability of COVID revenues and perhaps lay out the sort of the volume and the price element of it beyond 2022. And if you could also perhaps speak to the pricing seen in your Canadian contracts, whether it's consistent in 2023, '24 versus where it was in the '21 contract.
弗蘭克,你在三月發表的評論引起了很多關注。我想也許你可以詳細說明一下你如何看待新冠疫情收入的持久性,或許還可以列出 2022 年之後的數量和價格因素。如果你也可以談談定價在您的加拿大合約中可以看到,2023年、24 年合約與21 年合約是否一致。
And then I had a quick R&D one as well, if I may. I know there's these additional FDA technical requests on the gene therapy assay for DMD. I recall you guys were using ITR in Phase 1 and then you switched to a transgene assay in Phase 3 because it was a little more low variability. Is FDA now thinking the variability is higher than they want in the transgene assay as well? I'm just trying to understand what the word "matrix" means. Is it still just the transgene assay with different methods or are there multiple assays at play now?
如果可以的話,然後我也進行了快速研發。我知道 FDA 對 DMD 基因治療檢測還有這些額外的技術需求。我記得你們在第一階段使用 ITR,然後在第三階段改用基因改造檢測,因為它的變異性較低。 FDA 現在是否認為基因改造檢測中的變異性也高於他們想要的?我只是想理解「矩陣」這個字的意思。仍然只是使用不同方法的轉基因檢測還是現在有多種檢測在起作用?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Frank?
坦率?
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Thank you, Albert. So on pricing, Umer, I really want to not get into detail on pricing other than obviously, there are certain contracts where we disclose what the price is. In terms of the way I think about this, what we're really focused on now is getting doses to the patients that need doses around the world. So we're getting people vaccinated. That's been our focus. We're acutely focused on that.
謝謝你,艾伯特。因此,關於定價,Umer,我真的不想透露定價的細節,除了顯然,我們在某些合約中披露了價格。就我的想法而言,我們現在真正關注的是為世界各地需要劑量的患者提供劑量。所以我們正在讓人們接種疫苗。這是我們的重點。我們非常關注這一點。
You heard in our prepared remarks, we said we can make approximately 2.5 billion doses this year. We can take that up to 3 billion doses next year. And that's what we're really focused on, right, getting those made, getting them delivered and getting vaccines into patients' arms. So that's the focus.
你在我們準備好的發言中聽到了,我們說今年我們可以生產大約 25 億劑疫苗。明年我們可以服用多達 30 億劑。這就是我們真正關注的,對吧,製造這些疫苗,交付它們並將疫苗送入患者的懷抱。這就是重點。
On the Canada contract, we didn't discuss pricing on that contract. What we did say was up to 125 million doses in 2022 and 2023, with an option for more doses in 2024. And then in terms of the durability of the franchise, I'm going to try not to repeat what Albert said, but I thought Albert went into a lot of detail on why we believe the COVID revenue franchise has significant durability and why we think we see that as something that's going to take place for the foreseeable future. And Albert went through a lot of the details how we believe that is.
在加拿大合約中,我們沒有討論該合約的定價。我們確實說過的是,在2022 年和2023 年,疫苗接種量將達到1.25 億劑,並可以選擇在2024 年提供更多劑量。然後,就特許經營權的持久性而言,我將盡量不重複Albert 所說的話,但我艾伯特詳細解釋了為什麼我們相信新冠疫情收入特許經營權具有顯著的持久性,以及為什麼我們認為這將在可預見的未來發生。艾伯特詳細介紹了我們認為的許多細節。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Frank. Mikael, about the technical question?
謝謝你,弗蘭克。 Mikael,關於技術問題?
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Yes. The core assays that you alluded to related to AAV and the transgene effectiveness are all without any real comments by FDA, so they're all fine. This is what I call the supportive assay, an adjunct assay that was more related to co-localization of the DMD protein and discussions on various technologies how to measure that. And as I said, in Europe, as this was an adjunct assay in other countries, we have cleared and enrolled efficiently and progressing towards the next step of the trial very well. So it's a very technical issue how to do a detection but not related to the core potency assays. And obviously, we're working to resolve it. But what I understand currently, there is no other potential gene therapy in U.S. that had cleared yet to a Phase 3. And we obviously would like to be first, no just ex U.S. where we've been going for 6 months but within U.S. and work diligently to resolve this very technical question.
是的。你提到的與 AAV 和基因改造有效性相關的核心檢測都沒有得到 FDA 的任何真正評論,所以它們都很好。這就是我所說的支持性測定,一種輔助測定,與 DMD 蛋白的共定位以及如何測量該蛋白的各種技術的討論更相關。正如我所說,在歐洲,由於這是其他國家的輔助檢測,我們已經有效地進行了審批和登記,並且試驗的下一步進展順利。因此,如何進行檢測是一個非常技術性的問題,但與核心效力測定無關。顯然,我們正在努力解決這個問題。但據我目前了解,美國還沒有其他潛在的基因療法已進入第三階段。我們顯然希望成為第一個,不僅僅是在美國以外,我們已經進行了 6 個月,而是在美國和美國境內努力解決這個非常技術性的問題。
Operator
Operator
Your next question comes from Tim Anderson from Wolfe Research.
您的下一個問題來自沃爾夫研究中心的蒂姆·安德森。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
A couple of questions, please. On mRNA and your flu vaccine plans, how would a trial be constructed and really, what's the goal? Are you looking to show superiority on efficacy or just hoping to achieve parity with existing vaccines? And you talked about yours being quadrivalent, so presumably, if there is a comparator, that would be something like Sanofi's Flublok. Also, what would be the likely development timeline? I'm guessing it's not as fast as the COVID vaccine. It would take something longer, maybe a couple of years. And then a separate question on your 5-year guidance. Just to make sure I understand your earlier comments on pricing. What does your 5-year guidance assume about drug pricing, especially in the context of there possibly being European drug pricing austerity measures due to COVID?
請教幾個問題。關於 mRNA 和您的流感疫苗計劃,試驗將如何建構?實際上,目標是什麼?您是希望展現功效優勢還是只是希望與現有疫苗達到同等水平?你談到你的產品是四價的,所以想必,如果有一個比較器,那就是賽諾菲的 Flublok 之類的東西。另外,可能的開發時間表是什麼?我猜它的速度不如新冠疫苗。這需要更長的時間,也許幾年。然後是關於您的 5 年指導的單獨問題。只是為了確保我理解您之前對定價的評論。你們對藥品定價的 5 年指導有何假設,特別是在歐洲可能因新冠疫情而採取藥品定價緊縮措施的情況下?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. Thank you, Tim. And Mikael, do you want to take the question about the flu?
是的。謝謝你,提姆。米凱爾(Mikael),你想回答有關流感的問題嗎?
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. With the flu vaccine, given the strong immune response we have seen for our mRNA platform, we certainly hope to be able to show substantial differentiation versus current flu vaccine. This is, of course, the aspiration we have. Technically, there will be 2 components. One is to look at immune response on antibodies that have certain standards reported related to increase in titer. And we will be able to compare to the current protein-based flu vaccines. And then we're also planning to run a vaccine efficacy study, where we think it's not just what we hope to be a very potent antibody response but also the T cell response.
是的。對於流感疫苗,鑑於我們已經看到我們的 mRNA 平台產生了強烈的免疫反應,我們當然希望能夠顯示出與目前流感疫苗的顯著差異。這當然是我們的願望。從技術上講,將有 2 個組件。一種是觀察抗體的免疫反應,這些抗體具有與滴度增加相關的某些標準。我們將能夠與目前基於蛋白質的流感疫苗進行比較。然後我們還計劃進行一項疫苗功效研究,我們認為這不僅是我們希望產生非常有效的抗體反應,而且也是 T 細胞反應。
So I would certainly aspire to that we would have a vaccine that is to be substantially meaningful, better than the current vaccine based on the platform by itself but also based on that we are able so fast to align the platform with the sequence of the emerging flu strains, while as you may know, many years, the protein-based are misaligned, and that's why you get very modest vaccine efficacy on maybe just 50% and similar for immune responses. So given that we saw 95% efficacy against COVID, we think there is a large margin for us to improve on the current flu vaccine.
因此,我當然希望我們能夠擁有一種具有重大意義的疫苗,它比目前基於該平臺本身的疫苗更好,但也基於我們能夠如此迅速地將平台與新興病毒的序列保持一致。流感病毒株,而您可能知道,多年來,基於蛋白質的疫苗效果不一致,這就是為什麼您獲得的疫苗功效非常有限,可能只有50%,免疫反應也類似。因此,考慮到我們對新冠病毒的療效達到了 95%,我們認為我們對目前的流感疫苗還有很大的改進空間。
On the timing, Albert said we are moving to start human trials in Q3. And we will obviously, early on, generate data on the immunogenicity. And if that continued to go as well as our aspiration, we think we can move very fast with this vaccine and also utilizing the type of approach where you establish a large number of sites in the regions to study in order to enroll very fast. And we will look at various ways to register this vaccine and also how that could coincide with the recommendation by ACIP. So while we don't give at this early time an exact date but anticipate that we will move very fast, may not be as fast as a pandemic development but much faster than the traditional flu development.
關於時間安排,阿爾伯特表示我們將在第三季開始人體試驗。顯然,我們將儘早產生有關免疫原性的數據。如果這種情況繼續下去,以及我們的願望,我們認為我們可以非常快速地開發這種疫苗,並利用在這些地區建立大量研究地點的方法,以便快速註冊。我們將研究註冊這種疫苗的各種方法,以及如何與 ACIP 的建議一致。因此,雖然我們沒有儘早給出確切的日期,但預計我們的行動將會非常快,可能不會像大流行病的發展那麼快,但比傳統流感的發展要快得多。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Mikael. And then, Frank, I know you did answer the pricing, but do you want to say a little bit more about it?
謝謝你,米凱爾。然後,弗蘭克,我知道你確實回答了定價問題,但你想多說一點嗎?
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Sure, Albert. And this was more about the 5-year CAGR through 2025.
當然,艾伯特。這更多的是關於到 2025 年的 5 年複合年增長率。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Correct.
正確的。
Frank A. D'Amelio - CFO & Executive VP of Global Supply
Frank A. D'Amelio - CFO & Executive VP of Global Supply
So I think, Tim, the way I think about it is, we really look at pricing by geographic region. And we continue to believe it's going to be a headwind by geographic region. What would be examples of that? The U.S. would be one, emerging markets would be one. Developed Europe would be one, just as an example. They all range in, I'll call it, negative pricing increases and the range is low single digits to high single digits. And obviously, we blend that all together into an overall global rate, and that's what we've assumed in our CAGR assumptions through 2025.
所以我認為,蒂姆,我的想法是,我們確實按地理區域來考慮定價。我們仍然相信這將成為地理區域的逆風。有哪些例子?美國將是其中之一,新興市場也是其中之一。舉個例子,發達的歐洲就是其中之一。我稱之為負價格上漲,範圍從低個位數到高個位數。顯然,我們將所有這些綜合起來形成全球整體成長率,這就是我們在 2025 年複合年增長率假設中所假設的。
Operator
Operator
Your final question comes from the line of Navin Jacob from UBS.
你的最後一個問題來自瑞銀集團的納文·雅各布(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
Just a couple on the mRNA vaccines that you're pushing forward. You had been working with BioNTech for your flu vaccine. I just want to confirm that you're using the Pfizer mRNA technology for the flu vaccine that you're moving forward with. And curious as to why you're going with that approach beyond just the economic benefit of using your own tech versus something that you're collaborating with on. Is there something different about your mRNA technology, whether it's in the non-COVID portions of the vaccine or the LNP? And then secondly, again, on the flu vaccine, what is your ability to co-formulate it with the COVID vaccine? I'm wondering why you're moving forward at the co-formulated Prevnar 20 plus 162b2 and not looking for a flu vaccine co-formulation.
簡單介紹一下你們正在推進的 mRNA 疫苗。您一直在與 BioNTech 合作生產流感疫苗。我只是想確認您正在使用輝瑞 mRNA 技術來開發您正在開發的流感疫苗。我很好奇為什麼你要採用這種方法,而不僅僅是使用你自己的技術而不是與你合作的技術所帶來的經濟利益。無論是疫苗的非新冠部分還是 LNP,你們的 mRNA 技術有什麼不同嗎?其次,關於流感疫苗,你們將其與新冠疫苗聯合配製的能力如何?我想知道為什麼您要繼續使用 Prevnar 20 加 162b2 複合配方,而不是尋找流感疫苗複合配方。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
As regards to flu vaccine, we had a collaboration with BioNTech that goes back to 2018. At the time, we had announced also publicly some of the terms of this agreement. And the developments are based on the work that has been done so far by both companies on the flu.
關於流感疫苗,我們和BioNTech的合作可以追溯到2018年。當時我們也公開宣布了這個協議的一些條款。這些進展是基於兩家公司迄今為止在流感方面所做的工作。
As regard to the question of co-formulating, we didn't announce a co-formulation with Prevnar right now. We announced a co-administration with Prevnar. Clearly, we are looking at options to co-formulate the BioNTech-Pfizer mRNA vaccine against COVID with other, let's say, vaccines. But this is not what we spoke about today and we haven't made final decisions on co-formulation. And I think, Chuck, we do not have time for another question, right?
關於聯合配方的問題,我們現在沒有宣布與 Prevnar 聯合配方。我們宣布與 Prevnar 共同給藥。顯然,我們正在尋找將 BioNTech-Pfizer mRNA 疫苗與其他疫苗(比如說疫苗)共同配製的方案。但這不是我們今天討論的內容,我們還沒有就聯合配方做出最終決定。我想,查克,我們沒有時間再問另一個問題了,對吧?
Charles E. Triano - SVP of IR
Charles E. Triano - SVP of IR
That's right, Albert. Just your closing remarks.
沒錯,艾伯特。只是您的結束語。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
I wanted to thank everyone for joining us today and for your continued engagement with Pfizer. I'm thinking the pandemic has been the ultimate test for Pfizer's and, in truth, the entire pharmaceutical industry's capabilities and credibility. And in my view, we have, thus far, passed with flying colors.
我要感謝大家今天加入我們並感謝你們與輝瑞的持續合作。我認為這場大流行是輝瑞乃至整個製藥業能力與信譽的終極考驗。在我看來,到目前為止,我們已經出色地通過了。
The success of our COVID-19 vaccine has led to an important question. If we could do this for COVID-19, why not for other diseases? There are so many people suffering from other serious diseases and their needs aren't any less urgent. We now see an opportunity to take the lessons learned and new ways of thinking and apply them across our entire portfolio.
我們的 COVID-19 疫苗的成功引發了一個重要問題。如果我們可以針對 COVID-19 做到這一點,為什麼不能針對其他疾病呢?有很多人患有其他嚴重疾病,他們的需求也同樣緊迫。我們現在看到了一個機會,可以吸取經驗教訓和新的思維方式,並將其應用到我們的整個投資組合中。
The speed with which we interact with regulators as well as the continued acceleration of digital solutions such as artificial intelligence, electronic diaries, advanced analytics, electronic health records are just some of the things we plan to bring to all of our clinical trials so we can continue to move at the speed of science.
我們與監管機構互動的速度以及人工智慧、電子日記、高級分析、電子健康記錄等數位解決方案的持續加速只是我們計劃在所有臨床試驗中引入的一些內容,以便我們能夠繼續以科學的速度前進。
And now before we end the call, I want to take a moment to extend my thanks and very best wishes to our colleague and good friend of mine, Chuck Triano, who will be retiring at the end of September. Chuck has been interacting with the global investment community for nearly 35 years, including the past 13 years here at Pfizer. And I think all of you would agree that during that time, he has elevated Pfizer's investor relations function to a best-in-class. That's because he values clarity, integrity and transparency in the way we communicate. And it is because he has a passion for our company and our industry that makes him an outstanding champion for both.
現在,在結束通話之前,我想花點時間向我們的同事和我的好朋友查克·特里亞諾(Chuck Triano)表示感謝和最良好的祝愿,他將於 9 月底退休。 Chuck 與全球投資界互動已近 35 年,其中包括過去 13 年在輝瑞 (Pfizer) 的工作。我想你們所有人都會同意,在那段時間裡,他將輝瑞的投資者關係職能提升到了一流的水平。這是因為他重視我們溝通方式的清晰度、完整性和透明度。正是因為他對我們公司和產業充滿熱情,使他成為這兩者的傑出擁護者。
The good news is he will be around for at least one more earnings cycle and perhaps another as he has agreed to stay on as advisor during this transition. Chuck, thank you for being a valued colleague and friend. Pfizer will miss you, but on behalf of all of us, I wish you all the best in the next part of your journey. Thank you, everyone, and have a great rest of your day.
好消息是,他將至少再經歷一個盈利週期,甚至可能是另一個盈利週期,因為他同意在這次過渡期間繼續擔任顧問。查克,謝謝你成為一位有價值的同事和朋友。輝瑞會想念您,但我代表我們所有人祝您在接下來的旅程中一切順利。謝謝大家,祝您今天休息愉快。
Operator
Operator
This concludes today's conference. You may now all disconnect.
今天的會議到此結束。你們現在可以斷開連結了。