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Operator
Operator
Good day, everyone, and welcome to Pfizer's Second Quarter 2022 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Chris Stevo, Senior Vice President and Chief Investor Relations Officer. Please go ahead, sir.
大家好,歡迎參加輝瑞 2022 年第二季度收益電話會議。今天的電話正在錄音。此時,我想將電話轉給高級副總裁兼首席投資者關係官 Chris Stevo 先生。請繼續,先生。
Christopher J. Stevo - Senior VP & Chief IR Officer
Christopher J. Stevo - Senior VP & Chief IR Officer
Thank you, Chelsea. Good morning, everyone. Welcome to Pfizer's Second Quarter Earnings Call. We anticipate that this call will last 90 minutes. I'm joined today by Dr. Albert Bourla, our Chairman and CEO; Dave Denton, our CFO; and Mikael Dolsten, President of Worldwide Research & Development and Medical. Joining for the Q&A session, we will also have Angela Hwang, Group President, Pfizer Biopharmaceuticals Group; Aamir Malik, our Chief Business Innovation Officer; William Pao, our Chief Development Officer; and Doug Lankler, our General Counsel.
謝謝你,切爾西。大家,早安。歡迎來到輝瑞公司的第二季度財報電話會議。我們預計本次通話將持續 90 分鐘。今天,我們的董事長兼首席執行官 Albert Bourla 博士加入了我的行列;我們的首席財務官 Dave Denton;以及全球研發和醫療總裁 Mikael Dolsten。參加問答環節的還有輝瑞生物製藥集團總裁Angela Hwang;我們的首席業務創新官 Aamir Malik;我們的首席開發官 William Pao;和我們的總法律顧問 Doug Lankler。
The materials of this call and other earnings-related materials are on the Investor Relations section of pfizer.com. Please see our forward-looking statements disclaimer on Slide 3. And additional information regarding these statements and our non-GAAP financial measures is available in our earnings release and in our SEC Forms 10-K and 10-Q under Risk Factors and Forward-Looking Statements. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements.
本次電話會議的材料和其他與收益相關的材料位於 pfizer.com 的投資者關係部分。請在幻燈片 3 上查看我們的前瞻性聲明免責聲明。有關這些聲明和我們的非公認會計原則財務指標的更多信息可在我們的收益發布和我們的風險因素和前瞻性的 SEC 表格 10-K 和 10-Q 中獲得聲明。關於電話會議的前瞻性陳述存在重大風險和不確定性,僅在電話會議的原始日期發表,我們不承擔更新或修改任何陳述的義務。
With that, I will turn the call over to Albert.
有了這個,我會把電話轉給阿爾伯特。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Chris. Hello, everyone. I'm proud to say that Pfizer continued to deliver strong operational performance in the second quarter and has increased its full year 2022 operational financial forecast for revenue and Adjusted diluted earnings per share, all while operating in a challenging foreign exchange environment.
謝謝你,克里斯。大家好。我很自豪地說,輝瑞在第二季度繼續提供強勁的運營業績,並提高了對收入和調整後稀釋每股收益的 2022 年全年運營財務預測,同時在充滿挑戰的外匯環境中運營。
Compared with the second quarter of 2021, global revenues were up 53% operationally to $27.7 billion and Adjusted diluted EPS increased 100% operationally to $2.04. Both results exceeded consensus analyst expectations, and the quarterly revenue figure represented the largest in Pfizer's history. Key growth drivers for the quarter including PAXLOVID, COMIRNATY, ELIQUIS and VYNDAQEL/VYNDAMAX globally and our Prevnar family of products in the U.S.
與 2021 年第二季度相比,全球運營收入增長 53% 至 277 億美元,調整後的稀釋後每股收益運營增長 100% 至 2.04 美元。這兩項結果都超出了分析師的普遍預期,季度收入數字是輝瑞歷史上最高的。本季度的主要增長動力包括全球 PAXLOVID、COMIRNATY、ELIQUIS 和 VYNDAQEL/VYNDAMAX 以及我們在美國的 Prevnar 系列產品。
Year-to-date, we have reached an estimated 845 million patients around the world with our innovative medicines and vaccines, which represents a 77% increase from the prior year period. And we did all of this while also taking steps to help address broader issues impacting global health, including climate change, equitable access and the war in Ukraine.
年初至今,我們的創新藥物和疫苗已惠及全球約 8.45 億患者,比去年同期增長 77%。我們在做這一切的同時還採取措施幫助解決影響全球健康的更廣泛問題,包括氣候變化、公平准入和烏克蘭戰爭。
So where do we go from here? After 2.5 long years, like everyone else, we would hope that this global health crisis would be over soon. But as much as hope is important, hope is not science. And science is telling us that COVID-19 likely will remain a major global health care concern for years to come. We believe that Pfizer is well positioned not only to maintain but to grow both our commercial and scientific leadership in the battle against COVID-19.
那麼,我們該何去何從?在漫長的 2.5 年之後,和其他所有人一樣,我們希望這場全球健康危機能夠盡快結束。但是,儘管希望很重要,但希望不是科學。科學告訴我們,在未來幾年內,COVID-19 可能仍將是全球主要的醫療保健問題。我們相信,輝瑞在與 COVID-19 的戰鬥中不僅能夠保持而且能夠增強我們在商業和科學方面的領導地位。
In terms of our commercial leadership, we believe Pfizer's skills are even better suited for operating in open markets than they are for government-contracting markets and will be even more competitive when this transition happens. Recently, Angela announced a new commercial structure that prepares us to provide even better support for the ongoing COMIRNATY and PAXLOVID revenue streams.
就我們的商業領導力而言,我們相信輝瑞的技能更適合在公開市場運營,而不是在政府承包市場上運營,並且在這種轉變發生時將更具競爭力。最近,Angela 宣布了一項新的商業結構,使我們能夠為正在進行的 COMIRNATY 和 PAXLOVID 收入流提供更好的支持。
In terms of our scientific leadership, we expect to further enhance our position through the continued introduction of new innovations, including preparation for new variants of concern and potentially improving the durability of protection. So far, we have been fortunate that most of the variants have led to less severe illness. But there remains the possibility that a future variant could emerge that combines Omicron's contagiousness with the original virus' severity.
就我們的科學領導地位而言,我們希望通過持續引入新的創新來進一步提升我們的地位,包括為關注的新變體做準備,並可能提高保護的持久性。到目前為止,我們很幸運,大多數變異都導致了不太嚴重的疾病。但仍有可能出現將 Omicron 的傳染性與原始病毒的嚴重性相結合的未來變體。
This is a scenario no one wants to imagine, but one for which we need to be prepared. And that's why we're doing all these investments. That's why also it is critical that Pfizer continues to invest in the research and development of COVID-19 vaccines and treatments. With this context as a backdrop, let me provide an update on our current COVID-19 offerings and then continue with other products.
這是一個沒有人想想像的場景,但我們需要為此做好準備。這就是我們進行所有這些投資的原因。這就是為什麼輝瑞繼續投資於 COVID-19 疫苗和治療的研發也很重要的原因。以這種背景為背景,讓我提供有關我們當前 COVID-19 產品的更新,然後繼續介紹其他產品。
I will start with COMIRNATY. Today, we have shipped more than 36 billion doses of our vaccine in 180 countries and territories around the world. COMIRNATY remains the most utilized COVID-19 vaccine in the markets in which we operate that report market share data. Pfizer's cumulative share of doses administered in these markets have increased from 52% in January of this year to 63% in July of this year. In developed markets, our share has increased from 59% to 68% over the same time period.
我將從 COMIRNATY 開始。今天,我們已在全球 180 個國家和地區運送了超過 360 億劑疫苗。 COMIRNATY 仍然是我們運營的市場中使用最多的 COVID-19 疫苗,報告市場份額數據。輝瑞在這些市場的累計給藥劑量份額已從今年 1 月的 52% 增加到今年 7 月的 63%。在發達市場,我們的份額同期從 59% 增加到 68%。
Next, I would like to briefly touch on the topic of vaccine boosters for the fall. Outside the U.S., global regulators have issued guidance to advance an Omicron-adapted bivalent vaccine candidate to help address the continued evolution of the virus. As such, Pfizer and BioNTech have submitted data to the European Medicines Agency on the safety, tolerability and immunogenicity for the company's bivalent Omicron BA.1-adapted vaccine candidate. We also continue to work with health authorities around the globe on regulatory submissions.
接下來,我想簡要談談秋季疫苗增強劑的話題。在美國以外,全球監管機構已發布指南,以推進適應 Omicron 的二價候選疫苗,以幫助應對病毒的持續進化。因此,輝瑞和 BioNTech 已向歐洲藥品管理局提交了有關該公司二價 Omicron BA.1 適應疫苗的安全性、耐受性和免疫原性的數據。我們還繼續與全球衛生當局合作提交監管文件。
The U.S. Food and Drug Administration recently asked biopharmaceutical companies, including Pfizer, to develop a modified vaccine containing an Omicron BA.4/BA.5 component and begin clinical trials with these vaccine candidates. Pfizer is currently proceeding with development of a COVID-19 bivalent Omicron BA.4/BA.5 booster vaccine candidate and is targeting this fall for rollout in the U.S., subject, of course, to regulatory authorization. Pfizer is well positioned to satisfy its current contractual obligations and potential demand within its production capacity through the end of the year. Because of our robust manufacturing capabilities, we are planning to deliver both variant vaccines in the fall, pending regulatory approvals.
美國食品和藥物管理局最近要求包括輝瑞在內的生物製藥公司開發一種含有 Omicron BA.4/BA.5 成分的改良疫苗,並開始對這些候選疫苗進行臨床試驗。輝瑞公司目前正在開發一種 COVID-19 二價 Omicron BA.4/BA.5 加強疫苗候選者,併計劃於今年秋季在美國推出,當然,這需要獲得監管部門的授權。輝瑞有能力在年底前滿足其當前的合同義務和產能範圍內的潛在需求。由於我們強大的製造能力,我們計劃在秋季交付兩種變體疫苗,等待監管部門的批准。
Turning to PAXLOVID. We continue to be very pleased with how things are progressing in the U.S. as we are seeing several initiatives supporting increased access for eligible patients. First, the number of facilities with PAXLOVID supply have continued to increase with more than 41,000 sites live as of July 15, an increase of more than 7,000 sites since early May. We are pleased with the FDA's July 6 revision of the Emergency Use Authorization for PAXLOVID that authorized state-licensed pharmacists to prescribe the treatment under certain conditions, thereby expanding access for patients.
轉向 PAXLOVID。我們繼續對美國的進展感到非常滿意,因為我們看到了多項舉措支持增加符合條件的患者的訪問。首先,提供 PAXLOVID 的設施數量持續增加,截至 7 月 15 日已有 41,000 多個站點,自 5 月初以來增加了 7,000 多個站點。我們對 FDA 7 月 6 日對 PAXLOVID 緊急使用授權的修訂感到高興,該授權授權國家許可的藥劑師在某些條件下開具治療處方,從而擴大了患者的可及性。
As you can see on this slide, we have seen a nearly fivefold increase in PAXLOVID utilizations since the first quarter. We also continue to retain greater than 90% market share of oral COVID-19 treatments in the U.S. and are taking a state-by-state approach to engaging key government officials to discuss their access strategies. We are also continuing to work with states to educate consumers, health care providers and pharmacists about the importance of treating all appropriate high-risk patients rather than limiting treatment to the severely immunocompromised and unvaccinated.
正如您在這張幻燈片上看到的,我們看到 PAXLOVID 利用率自第一季度以來增長了近五倍。我們還繼續在美國保持超過 90% 的口服 COVID-19 治療市場份額,並正在採取逐州方法與主要政府官員討論他們的准入策略。我們還將繼續與各州合作,向消費者、醫療保健提供者和藥劑師宣傳治療所有適當的高風險患者的重要性,而不是將治療限制在嚴重免疫功能低下和未接種疫苗的患者身上。
In spite of the strong growth we have seen in PAXLOVID uptake in the U.S. due to our and the government's efforts, we estimate that the significant amount of eligible patients outside the U.S. are not yet being treated with the drug and may not know they are at high risk of progressing to severe disease. So we believe there remains substantial opportunity to grow PAXLOVID utilization.
儘管由於我們和政府的努力,我們看到 PAXLOVID 在美國的使用量強勁增長,但我們估計美國以外的大量符合條件的患者尚未接受該藥物治療,並且可能不知道他們處於發展為嚴重疾病的高風險。因此,我們相信仍有很大的機會來提高 PAXLOVID 的利用率。
For international developed markets, we are seeing significant increases in usage across many markets, reflecting the recent wave of BA.4/5 and the resulting increases in hospitalization, ICU admissions and deaths. For example, over the month from June 24 to July 24, average daily deaths in Europe almost doubled from a low of 0.6 per 1 million people to 1.15 per 1 million. In Japan, they almost tripled from 0.12 per 1 million people to 0.34 per 1 million people. And in Australia, they increased from 1.78 per 1 million people to 2.59 per 1 million.
對於國際發達市場,我們看到許多市場的使用量顯著增加,這反映了最近的 BA.4/5 浪潮以及由此導致的住院、ICU 入院和死亡人數的增加。例如,在 6 月 24 日至 7 月 24 日的一個月內,歐洲的平均每日死亡人數幾乎翻了一番,從每 100 萬人 0.6 人的低點增加到每 100 萬人 1.15 人。在日本,他們幾乎增加了兩倍,從每 100 萬人 0.12 人增加到每 100 萬人 0.34 人。在澳大利亞,他們從每百萬人 1.78 人增加到每百萬人 2.59 人。
While we have less precise numbers on market shares outside the U.S., our internal estimates indicate that we saw an estimated 116% increase in usage between June 24 and July 15 across international developed markets, where we have supply agreements. So we believe there is a significant opportunity to continue the growth outside the U.S. as physicians become more knowledgeable about PAXLOVID and treat appropriate patients.
雖然我們對美國以外市場份額的準確數字不太準確,但我們的內部估計表明,在我們簽訂了供應協議的國際發達市場,6 月 24 日至 7 月 15 日期間,我們的使用量估計增加了 116%。因此,我們相信隨著醫生對 PAXLOVID 更加了解並治療合適的患者,在美國以外繼續增長的重要機會。
While COVID-19 remains top of mind for many people, we are seeing encouraging performance with some of our other innovative products as well. And I wanted to take a moment to highlight two of them. We are very pleased with the success of our U.S. launch of Prevnar 20 for adults. Second quarter U.S. revenues for our Prevnar family of vaccines for adults were up 337% operationally compared with the prior year quarter to $431 million with Prevnar 20 representing more than 3/4 of the total adult revenue.
儘管 COVID-19 仍然是許多人的頭等大事,但我們的其他一些創新產品的表現也令人鼓舞。我想花點時間來強調其中的兩個。我們對在美國成功推出成人 Prevnar 20 感到非常高興。第二季度,我們的 Prevnar 系列成人疫苗在美國的運營收入比去年同期增長了 337%,達到 4.31 億美元,其中 Prevnar 20 佔成人總收入的 3/4 以上。
The great majority of U.S. health care networks, IDNs and retailers who have made formulary decisions have chosen Prevnar 20 alone as their higher valency pneumococcal vaccine of choice to help protect adults. This has resulted in Prevnar 20 having a 97% market share. This is also the first time there's been a routine recommendation for Prevnar for people in the 19 to 64 age group with underlying medical conditions. This group has an increased risk for contracting pneumococcal pneumonia and unfortunately has historically been the hardest to activate. Lastly, we believe the simplicity of Prevnar 20 being the only vaccine that can help protect patients with one dose in one visit is preferable to competitors' offerings.
做出處方決定的絕大多數美國醫療保健網絡、IDN 和零售商都選擇了 Prevnar 20 作為他們選擇的更高效價肺炎球菌疫苗,以幫助保護成年人。這導致 Prevnar 20 擁有 97% 的市場份額。這也是第一次為 19 至 64 歲年齡組有潛在疾病的人推薦 Prevnar。該群體感染肺炎球菌性肺炎的風險增加,不幸的是,該群體歷來是最難激活的。最後,我們認為 Prevnar 20 是唯一一種可以幫助保護患者一次就診一劑的疫苗,其簡單性優於競爭對手的產品。
Quarterly revenues for IBRANCE grew 1% in the U.S. compared with the same quarter last year despite a continued increase in the proportion of patients accessing IBRANCE through our Patient Assistance Program. This marked the first quarterly revenue uptick in the U.S. since the fourth quarter of 2020, which is an encouraging sign. Total volume in the U.S. increased 3% compared with the year-ago quarter.
儘管通過我們的患者援助計劃獲得 IBRANCE 的患者比例持續增加,但 IBRANCE 在美國的季度收入與去年同期相比增長了 1%。這標誌著美國自 2020 年第四季度以來的首次季度收入增長,這是一個令人鼓舞的跡象。美國的總銷量與去年同期相比增長了 3%。
Before I turn it over to Mikael, I want to touch on some actions we have taken recently to further demonstrate our commitment to environmental, social and governance, ESG, principles. We recently announced An Accord for a Healthier World. Under this accord, we are offering all of our patented, high-quality products that are available in the U.S. or the EU on a not-for-profit basis for 1.2 billion people living in 45 lower-income countries. This includes all future Pfizer products as well.
在我把它交給 Mikael 之前,我想談談我們最近採取的一些行動,以進一步證明我們對環境、社會和治理、ESG 原則的承諾。我們最近宣布了一個更健康世界的協議。根據該協議,我們將在非營利的基礎上向 45 個低收入國家的 12 億人提供我們在美國或歐盟可獲得的所有獲得專利的優質產品。這也包括輝瑞所有未來的產品。
I'm thrilled to say that the first product under this Accord has arrived in Rwanda with more on the way. Pfizer's experts also held a session with 100 Rwandan medical professionals to discuss efficacy, safety and dosing of this milestone. This is just the first step of accord's implementation, but an important one that will impact many lives.
我很高興地說,該協議下的第一個產品已經抵達盧旺達,更多產品即將推出。輝瑞的專家還與 100 名盧旺達醫療專業人員舉行了一次會議,討論這一里程碑的功效、安全性和劑量。這只是協議實施的第一步,但卻是影響許多人生活的重要一步。
We also recently announced our commitment to achieve the Net-Zero Standard across our value chain by year 2040. This is 10 years ahead of a new voluntary external standard. This includes aiming to reduce our company emissions by 95% and value chain emissions by 90% within the next roughly 18 years.
我們最近還宣布了到 2040 年在我們的價值鏈中實現淨零標準的承諾。這比新的自願外部標準提前了 10 年。這包括力爭在未來大約 18 年內將我們公司的排放量減少 95%,將價值鏈排放量減少 90%。
In response to the war in Ukraine, we are donating the equivalent of all profits from sales in Russia to causes that provide direct humanitarian support to the people of Ukraine. Our first down payment of $5 million is going to 8 global and local NGOs to support humanitarian relief and response efforts. And we will continue to channel these profits to the Ukrainian people until peace is achieved.
為應對烏克蘭戰爭,我們將相當於在俄羅斯銷售的所有利潤捐贈給為烏克蘭人民提供直接人道主義支持的事業。我們的第一筆 500 萬美元首付將用於 8 個全球和當地非政府組織,以支持人道主義救援和響應工作。我們將繼續將這些利潤輸送給烏克蘭人民,直到實現和平。
I am also very proud to share with you that in a recently published report from MSCI, Pfizer's annual ESG rating increased three notches compared with June 2021, going from B to A. This is just the latest external recognition we have received for our commitment to sustainable and ethical business practices. I couldn't be prouder for our colleagues' commitment to good governance practices, quality and integrity.
我也很自豪地與大家分享,在 MSCI 最近發布的一份報告中,輝瑞的年度 ESG 評級與 2021 年 6 月相比提高了三個等級,從 B 到 A。這只是我們對承諾的最新外部認可可持續和合乎道德的商業行為。我為我們的同事對良好治理實踐、質量和誠信的承諾感到無比自豪。
With that, I will turn it over to Mikael to update you on our R&D efforts. After Mikael, Dave will provide financial details on the second quarter and our outlook for the remainder of 2022.
有了這個,我將把它交給 Mikael 向您介紹我們的研發工作。在 Mikael 之後,Dave 將提供第二季度的財務細節以及我們對 2022 年剩餘時間的展望。
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Thank you, Albert. I'd like to start by highlighting two recent leadership appointments.
謝謝你,阿爾伯特。我想首先強調兩個最近的領導任命。
I've appointed Annaliesa Anderson to lead Vaccine Research & Development, succeeding Kathrin Jansen, who previously announced her retirement. With more than 2 decades of biopharma R&D experience, Liesa most recently served as CSO for Bacterial Research and Hospital. Over the last 2 years, she has led a team of infectious disease biologists that designed and delivered PAXLOVID to an Emergency Use Authorization. Under her leadership, we also advanced several bacterial vaccine programs into clinical development and approval.
我已任命 Annaliesa Anderson 領導疫苗研發,接替之前宣布退休的 Kathrin Jansen。 Liesa 擁有超過 2 年的生物製藥研發經驗,最近擔任細菌研究和醫院的 CSO。在過去的 2 年中,她領導了一個傳染病生物學家團隊,該團隊設計並交付了 PAXLOVID,以取得緊急使用授權。在她的領導下,我們還將幾個細菌疫苗項目推進了臨床開發和批准階段。
I've also named Charlotte Allerton CSO for Anti-Infectives, a new research unit. Creating this new research unit allows us to expand our focus beyond medicines that typically are used in hospitals. Charlotte is an esteemed scientist who will broaden our antiviral strategies with additional efforts in antibacterial and antifungal science and medicines. Charlotte has been our Head of Medicine Design, most notably co-leading the discovery and development of PAXLOVID, and will continue in that role as well.
我還命名了 Charlotte Allerton CSO for Anti-Infectives,這是一個新的研究單位。創建這個新的研究單位使我們能夠將重點擴展到醫院通常使用的藥物之外。 Charlotte 是一位受人尊敬的科學家,他將通過在抗菌和抗真菌科學和藥物方面的額外努力來拓寬我們的抗病毒策略。 Charlotte 一直是我們的醫學設計主管,最著名的是共同領導 PAXLOVID 的發現和開發,並將繼續擔任該職務。
I have had the privilege to work closely with Liesa and Charlotte for more than 10 years and have been continuously impressed by them as world-class scientists in their respective fields of expertise. Both have demonstrated good product-hunting skills and a sound business mindset. I'm looking forward to working with them in their new roles.
我有幸與 Liesa 和 Charlotte 密切合作 10 多年,他們作為各自專業領域的世界級科學家一直給我留下深刻印象。兩人都表現出良好的產品搜索技能和良好的商業思維。我期待著在他們的新角色中與他們合作。
Let's begin with COVID-19. The pandemic continues to evolve into a disease, which is causing significant disease burden, including high rates of acute disease, medical care utilization, hospitalization and deaths during the entire year. A growing number of patients affected by acute COVID infections are developing chronic disease and suffering from long COVID symptoms affecting multiple organs, such as the lungs, heart, kidney, brain and the vascular system. We have seen major waves of variants of concern emerge quickly, become dominant, then be superseded by the next variant. Omicron and its sublineages are the most antigenically distant compared to prior variants of concern, more transmissible and show evidence of partial immune escape from existing vaccines.
讓我們從 COVID-19 開始。大流行繼續演變成一種疾病,造成嚴重的疾病負擔,包括全年的急性疾病高發率、醫療保健利用率、住院率和死亡率。越來越多受急性 COVID 感染影響的患者正在發展為慢性疾病,並患有影響多個器官的長期 COVID 症狀,例如肺、心臟、腎臟、大腦和血管系統。我們已經看到關注的主要變體浪潮迅速出現,成為主導,然後被下一個變體取代。與之前關注的變體相比,Omicron 及其亞系在抗原性上最遙遠,更具傳播性,並顯示出現有疫苗部分免疫逃逸的證據。
As the composition of SARS-CoV-2 changes, it is essential we advance new approaches to extend the level of protection that COMIRNATY originally conveyed. In a clinical trial, we evaluated the safety, tolerability and immunogenicity of mono- and bivalent Omicron BA.1 modified vaccines administered as a fourth dose in more than 1,900 participants over age 55. We are also evaluating different doses of mono- and bivalent BA.1 in participants 18 to 55 years of age. While we saw promising responses to both mono- and bivalent versions in the over-55 population, we moved forward with bivalent following guidance from regulators.
隨著 SARS-CoV-2 的組成發生變化,我們必須推進新方法來擴展 COMIRNATY 最初傳達的保護水平。在一項臨床試驗中,我們評估了單價和二價 Omicron BA.1 改良疫苗作為第四劑在 1,900 多名 55 歲以上的參與者中的安全性、耐受性和免疫原性。我們還在評估不同劑量的單價和二價 BA .1 在 18 至 55 歲的參與者中。雖然我們在 55 歲以上的人群中看到了對單價和二價版本的有希望的反應,但我們在監管機構的指導下繼續推進二價版本。
The BA.1 vaccine candidate elicited a superior immune response for BA.1 compared to the current version of the vaccine, a seroresponse rate which exceeded non-inferiority, and neutralization activity which increased substantially. The BA.1 vaccine neutralized wild-type and Delta similarly to the current version of the vaccine, suggesting that Omicron-modified version maintained response for the ancestral and other viral variants.
與當前版本的疫苗相比,BA.1 候選疫苗對 BA.1 產生了更好的免疫反應,血清反應率超過了非劣效性,中和活性顯著提高。 BA.1 疫苗中和了野生型和 Delta 疫苗,與當前版本的疫苗相似,這表明 Omicron 修飾的版本保持了對祖先和其他病毒變體的反應。
Based on these data and following guidance from regulators, we have completed regulatory submissions in Europe, U.K. and Canada for the 30-microgram bivalent vaccine individuals 12 and older and plan submissions in other markets soon. The data also showed this vaccine candidate neutralized Omicron BA.4 and 5, though to a lesser extent than BA.1. This suggested a need to develop both a BA.1-modified vaccine and a BA.4/5-modified vaccine.
基於這些數據並遵循監管機構的指導,我們已在歐洲、英國和加拿大為 12 歲及以上的 30 微克二價疫苗個體完成了監管提交,併計劃很快在其他市場提交。數據還顯示,這種候選疫苗中和了 Omicron BA.4 和 5,儘管程度低於 BA.1。這表明需要同時開發 BA.1 修飾疫苗和 BA.4/5 修飾疫苗。
We studied BA.4/5 monovalent and bivalent booster candidates in mice and found a substantial increase in neutralization responses to all Omicron variants of concern. Neutralizing titers against BA.4/5 increased 11-fold for the monovalent and 4.8-fold for the bivalent compared to monovalent BA.1 vaccine. These data were shared at the recent FDA Advisory Committee meeting as a potential surrogate to help expedite development of a BA.4/5 vaccine.
我們研究了小鼠中的 BA.4/5 單價和二價增強劑候選物,發現對所有關注的 Omicron 變體的中和反應顯著增加。與單價 BA.1 疫苗相比,針對 BA.4/5 的中和效價對於單價疫苗增加了 11 倍,對於二價疫苗則增加了 4.8 倍。在最近的 FDA 諮詢委員會會議上分享了這些數據,作為幫助加快 BA.4/5 疫苗開發的潛在替代品。
We plan to submit the BA.4/5 bivalent vaccine candidate for Emergency Use Authorization in the U.S. in preparation for the fall booster campaign. To adapt more rapidly, we've agreed with FDA that this submission will be based on safety and immunogenicity data generated in adults with an Omicron-modified BA.1 vaccine and supported by BA.4/5 bivalent-specific preclinical data and BA.4/5 bivalent Chemistry, Manufacturing and Controls data.
我們計劃在美國提交 BA.4/5 二價候選疫苗以獲得緊急使用授權,為秋季加強活動做準備。為了更快地適應,我們與 FDA 達成一致,本次提交將基於成人使用 Omicron 修飾的 BA.1 疫苗產生的安全性和免疫原性數據,並得到 BA.4/5 二價特異性臨床前數據和 BA 的支持。 4/5 二價化學、製造和控制數據。
This strategy is bolstered by previous experience showing that overall responses have been similar between human clinical and mouse data, our clinical experience with Beta- and Omicron-modified vaccine candidates and by leveraging our mRNA platform and manufacturing experience for the current vaccine. To support future potential U.S. licensure and global registrations, we plan to initiate a clinical study to evaluate the BA.4/5 bivalent vaccine. The clinical study design is under discussion with FDA.
先前的經驗表明,人類臨床和小鼠數據之間的總體反應相似,我們對 Beta 和 Omicron 修飾的候選疫苗的臨床經驗以及利用我們的 mRNA 平台和當前疫苗的製造經驗支持了這一策略。為了支持未來潛在的美國許可和全球註冊,我們計劃啟動一項臨床研究以評估 BA.4/5 二價疫苗。臨床研究設計正在與 FDA 討論。
We aspire to continue leading with the science and are working to identify vaccines that would help provide strong and durable protection as new SARS-CoV-2 variants emerge. We aim to deliver a next-generation COVID-19 vaccine that can provide durable antibody and T cell immune protection against severe disease and hospitalization for at least 1 year. We plan to take a stepwise approach by designing and testing different candidates that engage multiple arms of the immune system, including antibodies and T cells.
我們渴望繼續引領科學,並正在努力尋找有助於在新的 SARS-CoV-2 變體出現時提供強大和持久保護的疫苗。我們的目標是提供下一代 COVID-19 疫苗,該疫苗可以提供針對嚴重疾病和住院至少 1 年的持久抗體和 T 細胞免疫保護。我們計劃採取循序漸進的方法,設計和測試涉及免疫系統多臂的不同候選者,包括抗體和 T 細胞。
First, yesterday, we announced the start of a Phase 2 study evaluating a bivalent modRNA vaccine candidate, which consists of RNAs encoding novel enhanced pre-fusion spike proteins for the SARS-CoV-2 ancestral strain and an Omicron variant. The enhanced spike protein encoded from the mRNA has been modified with the aim of increasing the magnitude and breadth of antibody neutralization response that could better protect against COV19. We project delivering key clinical data this fall.
首先,昨天,我們宣布開始一項評估二價 modRNA 候選疫苗的 2 期研究,該候選疫苗由編碼 SARS-CoV-2 祖先株的新型增強融合前刺突蛋白的 RNA 和 Omicron 變體組成。從 mRNA 編碼的增強型刺突蛋白已經過修飾,目的是增加抗體中和反應的幅度和廣度,從而更好地預防 COV19。我們計劃在今年秋天提供關鍵的臨床數據。
Second, we plan to initiate a proof-of-concept study with a potential pan-SARS-CoV-2 vaccine candidate by the end of the year. This combines the super-stabilized spike sequences with a T cell-enhancing construct, aiming to extend durability of protection against severe disease and new emerging SARS-CoV-2 variants.
其次,我們計劃在今年年底前對潛在的 pan-SARS-CoV-2 候選疫苗進行概念驗證研究。這將超穩定的尖峰序列與 T 細胞增強結構相結合,旨在延長針對嚴重疾病和新出現的 SARS-CoV-2 變體的保護的持久性。
Now turning to PAXLOVID. Last month, we submitted a new drug application to U.S. FDA seeking approval for the treatment of COVID-19 in both vaccinated and unvaccinated adults and pediatric patients 12 years and over, weighing at least 40 kilograms and at high risk for progression to severe illness. We anticipate a PDUFA date in the first quarter of 2023. We plan to generate further data in those who are immunocompromised, hospitalized with severe COVID-19 and at increased risk for poor outcomes due to the disease or who are pregnant. We also are considering multiple collaborative studies to evaluate potential treatment for long COVID.
現在轉向 PAXLOVID。上個月,我們向美國 FDA 提交了一份新藥申請,尋求批准用於治療已接種和未接種疫苗的成人和 12 歲及以上、體重至少 40 公斤且有進展為嚴重疾病的高風險的兒童患者的 COVID-19。我們預計 PDUFA 日期為 2023 年第一季度。我們計劃在免疫功能低下、因嚴重 COVID-19 住院以及因疾病或懷孕而導致不良結局風險增加的患者中生成更多數據。我們還在考慮進行多項合作研究,以評估長期 COVID 的潛在治療方法。
Finally, we're working with FDA to finalize a protocol to study patients who may be in need of retreatment. According to CDC, a brief return of symptoms may be part of the natural history of SARS-CoV-2 infection in some people. We believe the occurrence of COVID-19 rebound is uncommon and not uniquely associated with any specific treatment. At this time, cases are being reported at a rate consistent with the EPIC-HR trial.
最後,我們正在與 FDA 合作,敲定一項研究可能需要再治療的患者的方案。根據 CDC 的說法,症狀的短暫恢復可能是某些人感染 SARS-CoV-2 的自然病程的一部分。我們認為 COVID-19 反彈的發生並不常見,並且與任何特定治療無關。目前,病例報告的速度與 EPIC-HR 試驗一致。
Turning now to flu. We know that currently available vaccines are not optimal in addressing the unmet need as each year, many people are infected, hospitalized and die, resulting in tremendous public health and economic impact. In part, this is because the flu vaccine development cycle is inefficient. And even when the current seasonal vaccine strains match circulating strains well, they typically confer only 40% to 60% protection. Potential advantages of the mRNA platform include: shortened timeline to enable a quicker response each season; improved strain matching; faster and more reliable manufacturing; and broader immune response from both antibody and T cells, the latter needed particularly in older adults.
現在轉向流感。我們知道,目前可用的疫苗在解決未滿足的需求方面並不是最佳的,因為每年都有許多人被感染、住院和死亡,從而對公共健康和經濟產生巨大影響。部分原因是流感疫苗的開發週期效率低下。即使當前的季節性疫苗毒株與流行毒株很好地匹配,它們通常也只能提供 40% 到 60% 的保護。 mRNA 平台的潛在優勢包括: 縮短時間以實現每個季節更快的響應;改進的應變匹配;更快、更可靠的製造;以及來自抗體和 T 細胞的更廣泛的免疫反應,後者在老年人中尤其需要。
Based on our experience with COVID-19, T cell responses appear to be critical for the protection against severe disease and hospitalization in infectious viral disease. Here, we show Phase 2 T cell data for our quadrivalent modRNA flu vaccine candidates in subjects 65 and older. We believe this is the first evidence of a flu vaccine candidate inducing substantial responses for both CD4 and CD8 T cells.
根據我們對 COVID-19 的經驗,T 細胞反應似乎對於預防嚴重疾病和感染性病毒性疾病住院至關重要。在這裡,我們展示了 65 歲及以上受試者的四價 modRNA 流感疫苗候選者的 2 期 T 細胞數據。我們相信這是流感疫苗候選者誘導 CD4 和 CD8 T 細胞的實質性反應的第一個證據。
On the left, at day 7, the CD4 T cell response was more than twofold for all 4 flu strains for our vaccine compared to a current high-dose vaccine now recommended in the U.S. for adults 65 and older. Over half of the cohort receiving our vaccine candidate had a more than twofold response. On the right, at day 7, the CD8 T cell response and responder rates were greater for all 4 strains for our vaccine candidate versus the comparator.
在左側,在第 7 天,我們的疫苗對所有 4 種流感病毒株的 CD4 T 細胞反應比目前在美國推薦給 65 歲及以上成年人使用的高劑量疫苗的兩倍多。接受我們的候選疫苗的隊列中有超過一半的反應超過了兩倍。在右側,在第 7 天,我們的候選疫苗與對照疫苗相比,所有 4 株的 CD8 T 細胞反應和應答率都更高。
Our belief is that these encouraging T cell responses, combined with higher seroconversion rates for flu A strains, which are the most predominant circulating strains and have pandemic potential, may translate into improved efficacy over current seasonal flu vaccines, particularly in those 65 and older. Based on these data, we plan to initiate the Phase 3 efficacy study this year.
我們的信念是,這些令人鼓舞的 T 細胞反應,加上 A 型流感病毒株較高的血清轉化率,這些病毒株是最主要的循環病毒株,具有大流行的潛力,可能會轉化為比當前季節性流感疫苗更高的效力,特別是在 65 歲及以上的人群中。基於這些數據,我們計劃在今年啟動 3 期療效研究。
We are excited to share that new data on our oral GLP-1 receptor agonists, two abstracts on twice-daily danuglipron and one on our once-daily candidate known as 1532, have been accepted for the European Association for the Study of Diabetes Conference in September. These investigational medicines were decided in-house by Pfizer's innovative chemistry and discovery teams.
我們很高興分享我們的口服 GLP-1 受體激動劑的新數據,兩份關於每日兩次的 danuglipron 的摘要和一份關於我們每天一次的候選藥物 1532 的摘要,已被歐洲糖尿病研究協會會議接受九月。這些研究藥物由輝瑞的創新化學和發現團隊內部決定。
In a Phase 1 study in adults with type 2 diabetes, after only 6 weeks of treatment, 1532 drug robustly reduced mean daily glucose to almost near-normal levels. Participants also experienced weight loss of up to 5 kilograms compared with 2 kilograms for placebo. We believe this to be a potentially best-in-class profile across both injectables and orals. Similar changes in body weight were observed in participants with nondiabetic obesity.
在對患有 2 型糖尿病的成人進行的一項 1 期研究中,僅經過 6 週的治療,1532 種藥物就將平均每日血糖大幅降低至幾乎接近正常水平。參與者的體重減輕了 5 公斤,而安慰劑組減輕了 2 公斤。我們相信這可能是注射劑和口服劑的同類最佳配置文件。在非糖尿病性肥胖的參與者中觀察到類似的體重變化。
1532 is characterized by favorable once-daily pharmacokinetics, low risk for drug-drug interaction, robust efficacy across multiple metabolic endpoints and GLP-1 receptor agonist class-like tolerability, which overall encouraged us to plan for a Phase 2 study to pick the winning candidate prior to a potential Phase 3 study start. These development programs may lead to potential indications in type 2 diabetes, obesity, NASH and cardiovascular risk reduction in type 2 diabetes and obesity patients.
1532具有良好的每日一次藥代動力學、低藥物相互作用風險、跨越多個代謝終點的強大功效和 GLP-1 受體激動劑類耐受性的特點,這總體上鼓勵我們計劃進行 2 期研究以挑選獲勝者在潛在的第 3 階段研究開始之前的候選人。這些開發計劃可能會導致 2 型糖尿病和肥胖患者的 2 型糖尿病、肥胖症、NASH 和心血管風險降低的潛在適應症。
Over the 12 past months, we have built a strong Inflammation & Immunology portfolio with diverse products to help address multiple drivers of disease and unmet need. CIBINQO was approved for atopic dermatitis in adults and last week, received priority review designation in U.S. for adolescents 12 to 18 years. We are nearing a regulatory submission for etrasimod in ulcerative colitis. We have submitted regulatory application in U.S., Europe and U.K. for ritlecitinib for alopecia areata and are awaiting acceptances. We also plan to start a Phase 3 study of ritlecitinib in vitiligo this year. We are pleased to now share promising new updated data from our anti-interferon beta monoclonal antibody in specialized rheumatology.
在過去的 12 個月裡,我們建立了強大的炎症和免疫學產品組合,其中包含多種產品,以幫助解決疾病的多種驅動因素和未滿足的需求。 CIBINQO 被批准用於成人特應性皮炎,上週在美國獲得了針對 12 至 18 歲青少年的優先審查指定。我們正在接近提交用於潰瘍性結腸炎的依曲莫德的監管提交。我們已在美國、歐洲和英國提交了用於治療斑禿的 ritlecitinib 的監管申請,正在等待受理。我們還計劃今年啟動 ritlecitinib 治療白癜風的 3 期研究。我們現在很高興分享我們的抗干擾素 β 單克隆抗體在專門風濕病學中的有希望的新更新數據。
Patients with dermatomyositis show elevated Type I interferon gene signature in blood, skin and muscle correlating with disease activity in skin. As we continue our development of these candidates, a potential breakthrough therapy for hard-to-treat dermatomyositis which attacks skin and muscles, we believe it may have the ability to address a broader set of inflammatory autoimmune diseases, possibly including polymyositis and lupus. On our third quarter 2021 call, I shared data from our ongoing Phase 2 dermatomyositis study focused on skin inflammation and showing significant reduction in disease activity when compared with placebo in just 3 months of treatment.
皮肌炎患者在血液、皮膚和肌肉中顯示出升高的 I 型乾擾素基因特徵,這與皮膚中的疾病活動相關。隨著我們繼續開發這些候選藥物,這是一種潛在的突破性療法,可治療侵襲皮膚和肌肉的難治性皮肌炎,我們相信它可能有能力解決更廣泛的炎症性自身免疫性疾病,可能包括多發性肌炎和狼瘡。在我們 2021 年第三季度的電話會議上,我分享了我們正在進行的 2 期皮肌炎研究的數據,該研究的重點是皮膚炎症,並顯示與安慰劑相比,在短短 3 個月的治療中疾病活動顯著降低。
Now both doses met the primary efficacy endpoint in skin-predominant disease. The disease also manifests with progressively debilitating muscle weakness and fatigue. Early data suggests that in a small cohort of patients with muscle-predominant disease, our candidate resulted in numerically better efficacy scores across all key muscle endpoints, including patient-reported outcomes, after 3 weeks. We plan to submit the data for presentation once the study completes.
現在,兩種劑量都達到了以皮膚為主的疾病的主要療效終點。該疾病還表現為逐漸衰弱的肌肉無力和疲勞。早期數據表明,在一小群以肌肉為主的疾病患者中,我們的候選人在 3 週後在所有關鍵肌肉終點(包括患者報告的結果)上產生了數值上更好的療效評分。我們計劃在研究完成後提交數據以供展示。
Now a promising update on elranatamab, our investigational B cell maturation antigen CD3-targeted bispecific antibody. At ASCO, we presented data from a Phase 1 trial in people with relapsed/refractory multiple myeloma, whose disease is refractory to at least one agent in each of the three major classes of medications approved for the disease. We saw a confirmed overall response rate of 64%. And 35% of patients achieved a stringent complete response or complete responses. More than half who received prior BCMA-directed therapy, such as antibody drug conjugate or chimeric antigen receptor T cell therapy, achieved a response. Responders' probability of being event-free at 9 months was 77%.
現在對我們的研究性 B 細胞成熟抗原 CD3 靶向雙特異性抗體 elranatamab 進行了有希望的更新。在 ASCO,我們提供了來自複發/難治性多發性骨髓瘤患者的 1 期試驗數據,該患者的疾病對批准用於該疾病的三種主要藥物類別中的至少一種藥物無效。我們看到確認的總體響應率為 64%。 35%的患者達到嚴格的完全反應或完全反應。超過一半接受過先前 BCMA 定向治療(例如抗體藥物偶聯物或嵌合抗原受體 T 細胞治療)的患者取得了反應。響應者在 9 個月時無事件的概率為 77%。
Elranatamab elicited a durable minimal residual disease, or MRD, negativity, meaning no disease was detected after treatment in all evaluable patients who experienced a complete response or stringent complete response. Molecular responses were durable as well with 60% -- 62% of those complete responders documented to have MRD negativity at more than 6 months, including 2 patients who were MRD-negative beyond the 18 months.
Elranatamab 引發了持久的最小殘留疾病或 MRD 陰性,這意味著在經歷完全緩解或嚴格完全緩解的所有可評估患者中治療後未檢測到任何疾病。分子反應也很持久,有 60% - 62% 的完全反應者記錄在 6 個月以上時 MRD 呈陰性,其中包括 18 個月後 MRD 呈陰性的 2 名患者。
MagnetisMM-1 results and emerging data for MagnetisMM-3, which is studying triple-class refractory multiple myeloma, supports further development across a broader program with potential registration-enabling studies, MagnetisMM-5 in patients with double-class exposed multiple myeloma and MagnetisMM-7 in newly diagnosed post-transplant patients with multiple myeloma. There is potential for deep and durable results that can be broadly accessible to patients due to off-the-shelf, subcutaneous and convenient dosing. The efficacy and safety profile we have seen to date in a challenging patient population supports advancement into earlier lines of treatment.
MagnetisMM-1 結果和正在研究三級難治性多發性骨髓瘤的 MagnetisMM-3 的新數據支持在更廣泛的計劃中進一步發展,該項目具有潛在的註冊支持研究,即 MagnetisMM-5 在雙級暴露性多發性骨髓瘤和 MagnetisMM 患者中的應用-7 在新診斷的多發性骨髓瘤移植後患者中。由於現成的、皮下的和方便的給藥方式,患者可以廣泛獲得深度和持久的結果。迄今為止,我們在具有挑戰性的患者群體中看到的療效和安全性支持推進到更早的治療線。
Finally, here is a snapshot of select milestones for this year, showing healthy progress in the pipeline. It was an important quarter for COVID execution, and we look forward to sharing complete readouts from anti-interferon beta and the modFlu candidate before the end of the year.
最後,這是今年選定里程碑的快照,顯示了管道中的健康進展。這是 COVID 執行的重要季度,我們期待在年底前分享抗干擾素 beta 和 modFlu 候選藥物的完整讀數。
Thank you for your attention. Let me turn it over to Dave.
感謝您的關注。讓我把它交給戴夫。
David M. Denton - CFO, Executive VP
David M. Denton - CFO, Executive VP
Thank you, Mikael, and good morning, everyone. As this is my first call as CFO, I thought I would set the stage for the next chapter of Pfizer and our relentless focus on creating long-term shareholder value.
謝謝你,Mikael,大家早上好。由於這是我作為首席財務官的第一個電話,我想我將為輝瑞的下一章以及我們對創造長期股東價值的不懈關注奠定基礎。
Over the past few years, Pfizer's cash generation capabilities have expanded significantly. And the efficient deployment of this capital is more critical than ever. It is clear to me the company is uniquely positioned for both growth and, at the same time, enhancing financial returns. And as we look to the future of the company, we are focused on three primary areas to drive significant shareholder value.
在過去幾年中,輝瑞的現金生成能力顯著擴大。有效地部署這筆資金比以往任何時候都更加重要。我很清楚,該公司在增長和提高財務回報方面具有獨特的優勢。當我們展望公司的未來時,我們專注於三個主要領域,以推動顯著的股東價值。
First and foremost is our continued emphasis and investment in science and innovation. We are investing internally and externally to create breakthrough medicines, deploying more than $50 billion in this area in the past 3 years alone. Our second priority is maintaining and growing Pfizer's dividend, paying out more than $25 billion to shareholders over this period. We recognize that our dividend represents an important component of returns for our investors. And finally, from time to time, we will return capital to shareholders through value-enhancing share repurchases. Over the past 3 years, the company has allocated nearly $9 billion in this area. Clearly, maximizing shareholder value will be a major focus. And I believe that all three areas will contribute to our success.
首先是我們對科學和創新的持續重視和投資。我們正在內部和外部投資以創造突破性藥物,僅在過去 3 年就在該領域部署了超過 500 億美元。我們的第二個優先事項是維持和增加輝瑞的股息,在此期間向股東支付超過 250 億美元。我們認識到,我們的股息是我們投資者回報的重要組成部分。最後,我們將不時通過增值股票回購向股東返還資本。過去 3 年,該公司已在該領域撥款近 90 億美元。顯然,最大化股東價值將是一個主要關注點。我相信這三個領域都將為我們的成功做出貢獻。
More recently and year-to-date, we deployed more than $12 billion into innovation, paid dividends of $4.5 billion and repurchased $2 billion worth of our shares. This demonstrates an ongoing commitment to our robust capital deployment framework. With that, now let me briefly review our financial results for the quarter. I will confine my remarks largely to Adjusted and operational growth figures.
最近和年初至今,我們在創新方面投入了超過 120 億美元,支付了 45 億美元的股息,並回購了價值 20 億美元的股票。這表明我們對穩健的資本部署框架的持續承諾。有了這個,現在讓我簡要回顧一下我們本季度的財務業績。我將主要將我的評論限制在調整後的和運營增長的數據上。
Turning to the income statement. Revenues increased 53% operationally in the second quarter of 2022. These results were driven by momentum in PAXLOVID sales, strong sales of the COVID-19 vaccine and underlying strength from a number of our key products. Excluding PAXLOVID and COMIRNATY, Biopharma product revenues grew operationally by 2% compared to the prior year.
轉向損益表。 2022 年第二季度的運營收入增長了 53%。這些結果是由 PAXLOVID 銷售的勢頭、COVID-19 疫苗的強勁銷售以及我們一些關鍵產品的潛在實力推動的。不包括 PAXLOVID 和 COMIRNATY 的生物製藥產品收入在運營上比上一年增長了 2%。
In-line products, Xeljanz and Chantix were impacted by labeling changes and a global pause and shipments, respectively, while IBRANCE continued to transition into a new COVID normal market environment. PC1, our contract manufacturing business grew 89% operationally in the second quarter of 2021 and therefore faced a tough comparison versus last year with PC1 declining by 25% operationally. And now bringing that all together, Pfizer's non-COVID-related revenues grew by 1% operationally in the second quarter.
在線產品 Xeljanz 和 Chantix 分別受到標籤變化和全球暫停和發貨的影響,而 IBRANCE 繼續過渡到新的 COVID 正常市場環境。 PC1,我們的合同製造業務在 2021 年第二季度運營增長了 89%,因此與去年相比,PC1 運營下降了 25%,因此面臨嚴峻的比較。現在綜合起來,輝瑞公司第二季度與 COVID 無關的收入在運營上增長了 1%。
Adjusted cost of sales dollars grew more slowly than revenue, resulting in gross margin rate expansion of 570 basis points versus the second quarter of LY. This improvement in gross margin is largely due to the impact of higher-margin PAXLOVID sales, partially offset by higher COVID-19 vaccine sales and the impact of a $450 million write-off of COVID-related inventory that had expired or is expected to expire. Given the unpredictable nature of the virus, we chose to manufacture and hold excess stock to ensure we can meet any global health demand for products if an extreme need were to arise.
調整後的銷售成本增長慢於收入,導致毛利率與 LY 第二季度相比增長 570 個基點。毛利率的提高主要是由於更高利潤率的 PAXLOVID 銷售的影響,部分被更高的 COVID-19疫苗銷售以及 4.5 億美元的已過期或預計將過期的 COVID 相關庫存註銷的影響.鑑於該病毒的不可預測性,我們選擇製造並持有多餘的庫存,以確保在出現極端需求時能夠滿足全球對產品的任何健康需求。
Adjusted SI&A expenses in the second quarter grew by 7% operationally. The increase was primarily driven by spending for PAXLOVID and COMIRNATY and higher health care reform fees. The 27% operational increase in Adjusted R&D expense in Q2 was primarily driven by investments in multiple late-stage clinical programs, including programs to both prevent and treat COVID-19 and cost to develop recently acquired programs.
第二季度調整後的 SI&A 費用在運營上增長了 7%。這一增長主要是由 PAXLOVID 和 COMIRNATY 的支出以及更高的醫療改革費用推動的。第二季度調整後的研發費用增長了 27%,主要是由於對多個後期臨床項目的投資,包括預防和治療 COVID-19 的項目以及開發最近收購項目的成本。
The effective tax rate on Adjusted income in the quarter of 15.4% declined by 170 basis points versus last year driven by a favorable jurisdictional mix of earnings. And as a result, reported diluted earnings per share of $1.73 grew by 77% while Adjusted diluted earnings per share of $2.04 grew 92%. And on an operational basis, Adjusted diluted earnings per share grew 100% in the quarter. Foreign exchange movements continue to dampen our results negatively impacting revenues and adjusted earnings per share by 7% and $0.08 per share.
由於有利的轄區收益組合,本季度調整後收入的有效稅率為 15.4%,與去年相比下降了 170 個基點。因此,報告的每股攤薄收益為 1.73 美元,增長了 77%,而調整後的每股攤薄收益為 2.04 美元,增長了 92%。在運營基礎上,調整後的稀釋後每股收益在本季度增長了 100%。外匯波動繼續抑制我們的業績,對收入和調整後每股收益產生 7% 和每股 0.08 美元的負面影響。
So with that, let's move on to our 2022 guidance. Given our strong second quarter performance and our improving outlook for the year, we are increasing our operational expectations for both revenues and Adjusted earnings per share. For the full year, we are increasing our operational revenue expectations by $2 billion and operational Adjusted diluted earnings per share expectations by $0.24.
因此,讓我們繼續我們的 2022 年指導。鑑於我們強勁的第二季度業績和我們對今年前景的改善,我們正在提高對收入和調整後每股收益的運營預期。對於全年,我們將我們的運營收入預期提高了 20 億美元,將運營調整後的稀釋後每股收益預期提高了 0.24 美元。
Unfortunately, given additional U.S. dollar strengthening since we last updated guidance in early May, foreign exchange negatively impacts revenues by approximately $2 billion, leaving our reported revenue guidance range unchanged at $98 million to $102 billion. This represents an operational growth rate of 29% at the midpoint compared to 2021, a 200 basis point improvement over prior expectations.
不幸的是,鑑於自 5 月初我們上次更新指引以來美元進一步走強,外匯對收入的負面影響約為 20 億美元,使我們報告的收入指引範圍保持在 9800 萬美元至 1020 億美元不變。與 2021 年相比,這意味著中點的運營增長率為 29%,比之前的預期提高了 200 個基點。
The improvement in our operational Adjusted diluted earnings per share outlook of $0.24 is also negatively impacted by foreign exchange movements, compressing EPS by $0.19. The net impact of these cross-currents allows the company to raise the low end of its Adjusted earnings per share outlook by $0.05 to $6.30 to $6.45 a share. This represents 65% operational growth at the midpoint compared to 2021.
我們的運營調整後稀釋每股收益前景改善為 0.24 美元,這也受到外匯波動的負面影響,將每股收益壓縮了 0.19 美元。這些交叉流的淨影響使公司能夠將調整後每股收益前景的低端提高 0.05 美元至 6.30 美元至 6.45 美元。與 2021 年相比,這意味著中點的運營增長了 65%。
Regarding our COVID-19-related revenues. We continue to expect the vaccine revenue for the year to be approximately $32 billion, unchanged compared to the prior guidance provided on May 3, despite the impact of approximately $1 billion of incremental negative foreign exchange. For PAXLOVID, we expect sales of approximately $22 billion, keeping the guidance unchanged, again despite an incremental $300 million headwind due to FX. Our non-COVID-related revenues are absorbing approximately $700 million of impact from negative foreign exchange.
關於我們與 COVID-19 相關的收入。我們繼續預計今年的疫苗收入約為 320 億美元,與 5 月 3 日提供的先前指導相比保持不變,儘管增加了約 10 億美元的負外匯影響。對於 PAXLOVID,我們預計銷售額約為 220 億美元,保持指引不變,儘管由於外匯而增加了 3 億美元的逆風。我們與新冠病毒無關的收入正在吸收大約 7 億美元的負面外匯影響。
Now given the seasonality that we expect, I'd also like to give you some color on the expected cadence of these COVID-related revenues across the second half. Based on current guidance for COMIRNATY, we expect approximately 25% of second half sales in Q3 and 75% of sales in Q4, driven by expected deliveries of Omicron-adapted vaccines in Q4, again subject to regulatory approval. Conversely for PAXLOVID, we expect approximately 60% of sales in Q3 and 40% in Q4.
現在考慮到我們預期的季節性,我還想給你一些關於下半年這些與 COVID 相關的收入的預期節奏的顏色。根據目前對 COMIRNATY 的指導,我們預計第三季度下半年銷售額的約 25% 和第四季度銷售額的 75% 將受到第四季度 Omicron 適應疫苗的預期交付的推動,但仍需獲得監管部門的批准。相反,對於 PAXLOVID,我們預計第三季度的銷售額約為 60%,第四季度為 40%。
So with that, let me give you some detail on changes in our cost and expense guidance. We are decreasing our expected Adjusted SI&A spend by $300 million across the range to $12.2 billion to $13.2 billion. Additionally, we are also increasing our guidance for Adjusted R&D expense by $500 million at the low end only with the new range of $11.5 billion to $12 billion, reflecting incremental investments in multiple programs, including mRNA vaccine programs outside of COVID-19 and other programs. We are also slightly reducing our expected effective tax rate on Adjusted income by 50 basis points to approximately 15.5%. 2022 guidance once again assumes no incremental share repurchases beyond the $2 billion of share repurchases that we completed in March of 2022.
因此,讓我向您詳細介紹我們的成本和費用指南的變化。我們正在將預期的調整後 SI&A 支出減少 3 億美元,降至 122 億美元至 132 億美元。此外,我們還將調整後研發費用的指導僅在低端增加 5 億美元,新範圍為 115 億美元至 120 億美元,這反映了對多個項目的增量投資,包括 COVID-19 以外的 mRNA 疫苗項目和其他項目.我們還將調整後收入的預期有效稅率略微降低 50 個基點至約 15.5%。 2022 年指引再次假設,除了我們在 2022 年 3 月完成的 20 億美元股票回購之外,沒有增量股票回購。
So in closing, it's an exciting time in the history of Pfizer. We believe that our strong financial performance in the quarter and our improving operational outlook for the year sets the stage for long-term shareholder value creation. And so with that, I'll now turn it over to Chris and start the Q&A session.
最後,這是輝瑞歷史上激動人心的時刻。我們相信,我們本季度強勁的財務表現和我們今年不斷改善的運營前景為長期股東價值創造奠定了基礎。因此,我現在將把它交給 Chris 並開始問答環節。
Christopher J. Stevo - Senior VP & Chief IR Officer
Christopher J. Stevo - Senior VP & Chief IR Officer
Thanks, Dave. At this time, let's start the Q&A session. (Operator Instructions) If you have remaining questions afterwards, the IR team will be available to answer those questions for you as well. Chelsea, if you could queue up the callers, please?
謝謝,戴夫。這時候,讓我們開始問答環節。 (操作員說明)如果您之後還有其他問題,IR 團隊也會為您解答這些問題。切爾西,如果你能把來電者排隊,好嗎?
Operator
Operator
(Operator Instructions) Your first questions come from the line of Carter Gould from Barclays.
(操作員說明)您的第一個問題來自 Barclays 的 Carter Gould。
Carter Lewis Gould - Senior Analyst
Carter Lewis Gould - Senior Analyst
Appreciate all the disclosures there at the end. But I wanted to follow up on the COMIRNATY guide again. Obviously, you had some incremental contracts that got signed since the last time you gave guidance. You highlighted sort of the FX headwind. So I guess, trying to tease out exactly kind of explicitly kind of what you're assuming around potentially, I guess, EU doses getting pushed into 2023 and just some additional color there, if you can, please.
感謝最後的所有披露。但我想再次跟進 COMIRNATY 指南。顯然,自您上次提供指導以來,您簽署了一些增量合同。您強調了某種 FX 逆風。所以我想,試圖梳理出你所假設的確切類型,我想,歐盟的劑量將被推到 2023 年,如果可以的話,請在那裡提供一些額外的顏色。
David M. Denton - CFO, Executive VP
David M. Denton - CFO, Executive VP
Carter, this is Dave. Thank you for the question. Let me walk you through the guidance for this year from a vaccine perspective. As you well know, we had a guidance of $32 billion to begin with as we entered -- come out of Q1. There's really three moving parts as I think about our guidance for the year. One is we do have an incremental contract from the USG for 105 million doses this year, which is an uptick to that guidance. Secondly, we're experiencing headwinds from an FX perspective to the tune of $1 billion since Q1, but for the year, really $2 billion in that product alone.
卡特,這是戴夫。感謝你的提問。讓我從疫苗的角度向您介紹今年的指南。眾所周知,當我們進入第一季度時,我們一開始就有 320 億美元的指導。當我想到我們今年的指導時,實際上有三個活動部分。一個是我們今年確實與美國政府簽訂了一份增量合同,合同數量為 1.05 億劑,這是對這一指導的提升。其次,自第一季度以來,從外彙的角度來看,我們正經歷著 10 億美元的逆風,但今年僅在該產品中就真正達到了 20 億美元。
And then third, as I just articulated, the cadence of deliveries in the back half is really skewed to Q4. And with that, some ex-U.S. deliveries could move from November into December of the calendar year. And if that were to occur, given our 1-month lag from a reporting perspective, that would fall -- those revenues would fall into Q1 of 2023. I do not know whether that's going to happen, but I'm planning that it might happen. So therefore, I'm probably being conservative in my approach in my outlook to the revenue guide for that specific medicine.
第三,正如我剛才所說,後半部分的交付節奏確實偏向於第四季度。有了這個,一些前美國交付可能會從日曆年的 11 月移至 12 月。如果發生這種情況,考慮到我們從報告的角度來看滯後 1 個月,那將會下降——這些收入將下降到 2023 年第一季度。我不知道這是否會發生,但我計劃可能會發生。因此,我可能對特定藥物的收入指南前景持保守態度。
Operator
Operator
Your next questions come from the line of Robyn Karnauskas with Truist Securities.
您的下一個問題來自 Truist Securities 的 Robyn Karnauskas。
Robyn Kay Shelton Karnauskas - Research Analyst
Robyn Kay Shelton Karnauskas - Research Analyst
I guess, mine is on PAXLOVID. And maybe you could talk a little bit about -- I know there -- while you said there's low rates in line with clinical trials for rebounding, maybe that's under-reported and you outlined your plan for new trials. What are you doing in potentially decreasing that potential for rebounding in the new studies? Are you extending and doubling the dose? And maybe some trends, help us -- give us more color on some trends that you're seeing on PAXLOVID. I know you mentioned globally. We're hearing in some states, it's more limited versus others. Maybe just give us some more color there on trends you're seeing on access.
我想,我的在 PAXLOVID 上。也許你可以談談 - 我知道那裡 - 雖然你說反彈率低符合臨床試驗的反彈,也許這被低估了,你概述了你的新試驗計劃。你在做些什麼來降低新研究中反彈的可能性?您是否正在延長劑量並加倍劑量?或許還有一些趨勢,幫助我們——給我們更多關於你在 PAXLOVID 上看到的一些趨勢的顏色。我知道你提到了全球。我們在某些州聽到,與其他州相比,它更加有限。也許只是給我們一些關於您在訪問時看到的趨勢的顏色。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. William, why don't you speak a little bit about the program that we have about rebounding. And then Angela, you speak a little bit about the trend of the revenues and the uptake.
是的。威廉,你為什麼不談談我們關於籃板的計劃。然後安吉拉,你談了一點收入和吸收的趨勢。
William Pao - Chief Development Officer, Executive VP
William Pao - Chief Development Officer, Executive VP
Sure. Thanks, Albert, and thanks for the question. So as we reported earlier in the EPIC-HR study, we did see single-digit percent of potential rebound. But we also saw it in the placebo arm with a very similar rate. Since then, we have seen other studies coming out, including from the Mayo Clinic, Case Western, Kaiser Permanente and others showing data that's very consistent with ours in terms of single-digit percent of rebound. And it's also been seen not only with placebo but also with competitor antivirals. And internally, we also have data from real-world data as well as additional pharmacovigilance data showing again that it's a very similar low percentage rate of recurrence.
當然。謝謝,阿爾伯特,謝謝你的問題。因此,正如我們之前在 EPIC-HR 研究中報導的那樣,我們確實看到了潛在反彈的個位數百分比。但我們也在安慰劑組中看到了非常相似的比率。從那以後,我們看到了其他研究,包括來自 Mayo Clinic、Case Western、Kaiser Permanente 和其他研究的數據,這些研究在個位數的反彈百分比方面與我們的數據非常一致。不僅在安慰劑中,而且在競爭對手的抗病毒藥物中也出現了這種情況。在內部,我們也有來自真實世界數據的數據以及額外的藥物警戒數據,再次表明它的複發率非常相似,很低。
That said though, we are working with the FDA to finalize plans for a trial in which we would treat such patients. And we're still deciding on the final outline of that. And in addition, as Mikael outlined, we'll be looking at other cohorts of patients, for example, immunocompromised patients who have a large unmet medical need. And in that setting, we will be looking at, for example, 5, 10 and 15 days of dosing to determine the optimum dose regimen for those patients.
儘管如此,我們正在與 FDA 合作,以最終確定我們將治療此類患者的試驗計劃。我們仍在決定最終的大綱。此外,正如 Mikael 所概述的,我們將關注其他患者群體,例如,具有大量未滿足醫療需求的免疫功能低下的患者。在這種情況下,我們將研究例如 5、10 和 15 天的給藥,以確定這些患者的最佳劑量方案。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, William. And I need to say that we are very serious about PAXLOVID, and we are looking very diligently all the anecdotal reports that are coming. But all the data, I repeat all the data, our internal data that we are detecting rebounds by proactively checking viral loads or the external data that have been reported through pharmacovigilance to us or through studies that have been performed by third parties, very reputable third parties like Kaiser Permanente or Mayo Clinic, they are consistent that this is low single digit, actually less than 1% in the external studies. And it was, as we repeated, around 2% in the methodology we used in ours and very consistent with the numbers of the placebo. So although we try to see if there is a need to do something about it, seriously we can't find any data set other than anecdotal reports.
謝謝你,威廉。我需要說,我們對 PAXLOVID 非常認真,並且我們正在非常努力地查看所有即將到來的軼事報告。但是所有數據,我重複所有數據,我們通過主動檢查病毒載量來檢測反彈的內部數據或通過藥物警戒向我們報告的外部數據或通過第三方進行的研究,非常有信譽的第三方像 Kaiser Permanente 或 Mayo Clinic 這樣的政黨,他們一致認為這是低個位數,實際上在外部研究中不到 1%。正如我們重複的那樣,在我們使用的方法中,它大約是 2%,並且與安慰劑的數量非常一致。因此,儘管我們嘗試查看是否需要對此採取措施,但嚴重的是,除了軼事報告之外,我們找不到任何數據集。
Also, I want to emphasize that even the anecdotal reports, they are all indicating that it is mild. So we don't have any rebound that it is more serious, right? And clearly, we haven't identified any single case that we have resistance to the PAXLOVID. So we are looking into it, and William said that we are going to run also some studies. We are discussing our protocols with FDA to see if retreatment of those cases could help. But so far, our conclusion, although we are looking a lot, it is very small percentage, similar to COVID placebo or COVID other antivirals and with very mild symptoms. Angela, what about the trends internationally and in the U.S., if you want?
另外,我想強調的是,即使是軼事報導,也都表明它是溫和的。所以我們沒有更嚴重的反彈,對吧?顯然,我們還沒有發現任何一個我們對 PAXLOVID 有抵抗力的案例。所以我們正在研究它,William 說我們還將進行一些研究。我們正在與 FDA 討論我們的協議,看看對這些病例進行再治療是否有幫助。但到目前為止,我們的結論是,雖然我們看了很多,但比例非常小,類似於 COVID 安慰劑或 COVID 其他抗病毒藥物,並且症狀非常輕微。安吉拉,如果你願意,國際和美國的趨勢如何?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
So globally, I think that we're doing really well and making excellent progress. We have made and manufactured 30 million doses. And we've delivered 23.5 million of those doses. So I think that the contracting is going well, the demand and expectations for the need for PAXLOVID is definitely up there. But maybe let me use some U.S. examples, where things are -- where we have a little bit more data and where things that I think are going particularly well.
所以在全球範圍內,我認為我們做得非常好,並且取得了很好的進展。我們已經製造並生產了 3000 萬劑。我們已經交付了 2350 萬劑。所以我認為合同進展順利,對 PAXLOVID 的需求和期望肯定是有的。但也許讓我舉一些美國的例子,事情在哪裡——我們有更多的數據,而且我認為事情進展得特別好。
The U.S. actually contracted 10.8 million doses with us so far and 7.4 million doses of all of those have already been allocated to all the states. So I think that gives you a sense of how much demand is coming in from all of the states. And then every single week, our utilization of PAXLOVID has also increased. In fact, most recently, we hit an all-time high of 389,000 doses of PAXLOVID that were used just in 1 week. So that gives you a sense of sort of the increase and the momentum.
到目前為止,美國實際上與我們簽訂了 1080 萬劑合同,其中 740 萬劑已分配給所有州。因此,我認為這讓您了解所有州的需求量。然後每週,我們對 PAXLOVID 的使用率也在增加。事實上,最近,我們在 1 週內使用了 389,000 劑 PAXLOVID,創下歷史新高。所以這給你一種增加和動力的感覺。
What's really driving this is obviously the education and the familiarity and the experience now of physicians as well as patients but also the excellent work that is being done at the federal as well as the state level -- at the state level in terms of education and utilization. And I want to call out, in particular, the Test to Treat program that I think has been particularly effective and very positive. To date, more than 41,000 pharmacies are now Test to Treat centers. And that means that, that just gives access to a tremendous amount of the population to be able to access PAXLOVID.
真正推動這一切的顯然是醫生和患者現在的教育、熟悉程度和經驗,以及在聯邦和州一級所做的出色工作——在州一級的教育和利用率。我想特別指出我認為特別有效和非常積極的治療測試計劃。迄今為止,已有超過 41,000 家藥店成為“檢測治療中心”。這意味著,這只是讓大量人口能夠訪問 PAXLOVID。
And also recently, pharmacists are now able to prescribe PAXLOVID within certain limitations. And over and above whatever states and the federal government are doing, Pfizer is also aggressively and assertively supporting education. So actually, we have leveraged the entire Pfizer field force to provide education. We're running webinars. And to-date, we've reached over 300,000 health care professionals as well as 80,000 pharmacists, just to give you a sense of the extent and the breadth of reach that we have accomplished.
而且最近,藥劑師現在能夠在某些限制範圍內開出 PAXLOVID。除了各州和聯邦政府正在做的事情之外,輝瑞還積極而堅定地支持教育。所以實際上,我們已經利用整個輝瑞的現場力量來提供教育。我們正在舉辦網絡研討會。迄今為止,我們已經接觸了超過 300,000 名醫療保健專業人員和 80,000 名藥劑師,只是為了讓您了解我們所取得的成就的範圍和廣度。
I mean, all of that, also complemented by public service announcements about driving awareness of the treatment but also the individual risk that each patient could carry and making them aware that they could be a potential candidate for PAXLOVID. So I think with all of these efforts that have gone on and that we are continuing, we feel really good about the momentum of PAXLOVID, the utilization of PAXLOVID and the benefit that PAXLOVID can bring, particularly in a time when there's surges going on around the entire world.
我的意思是,所有這一切,還輔之以關於提高治療意識的公共服務公告,以及每個患者可能攜帶的個人風險,並讓他們意識到他們可能是 PAXLOVID 的潛在候選人。因此,我認為隨著所有這些努力的進行以及我們正在繼續,我們對 PAXLOVID 的勢頭、PAXLOVID 的利用以及 PAXLOVID 可以帶來的好處感到非常滿意,特別是在周圍出現激增的時候整個世界。
Operator
Operator
Your next questions come from the line of Terence Flynn with Morgan Stanley.
您的下一個問題來自摩根士丹利的 Terence Flynn。
Terence C. Flynn - Equity Analyst
Terence C. Flynn - Equity Analyst
I had a two-part one on your mRNA seasonal flu vaccine program. I was just wondering if you had any HAI titer data that you can share from the trial. We saw the T cell data. But again, I'm wondering if there's any titer data you can share. And then anything on the safety and tolerability there? Is it fair to assume that the profile is similar to COMIRNATY? Or are there any particular differences you'd like to call out?
我有一個關於你的 mRNA 季節性流感疫苗計劃的兩部分。我只是想知道你是否有任何可以從試驗中分享的 HAI 滴度數據。我們看到了 T 細胞數據。但同樣,我想知道您是否可以分享任何滴度數據。然後有什麼關於安全性和耐受性的嗎?假設配置文件與 COMIRNATY 相似是否公平?或者您有什麼特別想指出的區別嗎?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much, Terence. So Mikael, why don't you take this question?
非常感謝你,特倫斯。那麼Mikael,你為什麼不回答這個問題呢?
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. We will share details in upcoming conference. But I can just give a little bit more color. As you know, the highest medical burden and hospitalization occurs in the 65-plus, where the A strains are the most dominant. We had very strong titers against the A strains and exceeding what you would see with the current recommended vaccines. So we are very bullish about our ability with mRNA to induce both strong antibody response and CD4/CD8 T cells, which are not in used by current standard of care.
是的。我們將在即將舉行的會議上分享詳細信息。但我可以多給一點顏色。如您所知,最高的醫療負擔和住院發生在 65 歲以上,其中 A 株占主導地位。我們對 A 株的滴度非常強,超過了目前推薦的疫苗所見的效價。因此,我們非常看好我們利用 mRNA 誘導強抗體反應和 CD4/CD8 T 細胞的能力,目前的護理標準並未使用這些細胞。
And this is the reason why we are sharing today that we're announcing two Phase 3 studies. Tolerability -- sorry. Tolerability of this 30-microgram -- sorry, Terence, I didn't note that first. Tolerability is, of course, supported by our billions of doses of the platform in COVID. And on top of that, in older adults, the 30-microgram have a very good acceptance, the main patient group. And I believe it's going to be excellent and very similar to other available flu vaccines.
這就是我們今天分享我們宣布兩項 3 期研究的原因。耐受性——對不起。這個 30 微克的耐受性——對不起,特倫斯,我沒有先註意到這一點。當然,耐受性得到了我們數十億劑 COVID 平台的支持。最重要的是,在老年人中,30 微克的接受度非常好,主要患者群體。而且我相信它會非常好,並且與其他可用的流感疫苗非常相似。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. And also, Mikael, you spoke about A. You didn't speak about the B strains in the immunogenicity results. They were similar to the current high dose of quadrivalent.
是的。還有,Mikael,你談到了 A。你沒有談到免疫原性結果中的 B 株。它們與目前的高劑量四價藥物相似。
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 didn't mention the B strains. We noted in general, a lower response to B strains with both standard of care. And we hedged on the lower side with our vaccine. That's why I was so encouraged to see the unique T cell response against the B cell strain. And the totality of that data make us encouraged that we will have a strong product for both A and B.
是的。我沒有提到B菌株。我們一般注意到,兩種護理標準對 B 菌株的反應較低。我們用疫苗對沖了低端。這就是為什麼我很高興看到獨特的 T 細胞對 B 細胞株的反應。這些數據的全部使我們感到鼓舞的是,我們將為 A 和 B 提供強大的產品。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
And then I think how confident we feel it is that although the regulatory pathway, it is just demonstrate non-inferiority in immunogenicity, we are going for an efficacy trial. So the trial that is -- we announced yesterday is going to measure real efficacy in flu, which we believe that we expect -- of course, science is unpredictable, but we expect to win with flying colors.
然後我認為我們有多麼自信,雖然是調節途徑,但它只是證明免疫原性的非劣效性,我們正在進行療效試驗。因此,我們昨天宣布的試驗將測量流感的實際療效,我們相信這是我們所期望的——當然,科學是不可預測的,但我們希望以優異的成績獲勝。
Operator
Operator
Your next question comes from the line of Umer Raffat with Evercore ISI.
您的下一個問題來自於 Evercore ISI 的 Umer Raffat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
I had a question and a clarification. The question is on PAXLOVID. I know the Test to Treat program from the Biden administration has been a big driver of volumes. And my question is how would the demand dynamics change when we transition to a commercial purchasing model? And let's say the Test to Treat is still in place, would there be any change or not?
我有一個問題和一個澄清。問題是關於 PAXLOVID。我知道拜登政府的“治療測試”計劃一直是銷量的一大推動力。我的問題是,當我們過渡到商業採購模式時,需求動態會如何變化?假設治療測試仍然存在,是否會有任何變化?
And my clarification is, Mikael, I think some comments you might have made at a recent non-transcripted meeting on the TL1A program and whether there's been a signal consistent across the Phase 2a and Phase 2b. Could you please clarify that? And I'm referring to the interim announcements that happened recently.
我的澄清是,Mikael,我認為您可能在最近的一次非轉錄會議上就 TL1A 計劃以及階段 2a 和階段 2b 是否存在一致的信號發表了一些評論。你能澄清一下嗎?我指的是最近發生的臨時公告。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. Angela, what do you think? If we go to open commercial market, do you think that we will be better or worse off with PAXLOVID?
是的。安吉拉,你怎麼看?如果我們去開放商業市場,您認為使用 PAXLOVID 會更好還是更糟?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
So I think that there are elements that we will be able to implement in the commercial market that currently that we don't. So for sure, you've just heard me share comments about the efforts that we've put into PAXLOVID already here in the U.S. and ex U.S., right, the execution and the support of education, support of our entire field forces, support of retail, support of patients through education again and PSAs. All that will continue.
因此,我認為我們將能夠在商業市場中實施目前我們無法實施的一些要素。因此,可以肯定的是,您剛剛聽到我分享了關於我們已經在美國和前美國為 PAXLOVID 所做的努力的評論,對,執行和支持教育,支持我們整個外勤部隊,支持零售、通過再次教育和公益廣告支持患者。這一切都將繼續。
But I think what happens in a full commercial launch is that you will have multiple distributors and multiple points of distribution throughout the entire country. You will have stocking by every pharmacy and pharmacists and various points of use. And so I think that in a commercial setting, actually you'll be able to reach a much broader set of channels that we currently even do today. So I think that's one difference.
但我認為,在完整的商業發布中,您將在整個國家擁有多個分銷商和多個分銷點。您將有每個藥房和藥劑師以及各種使用點的庫存。所以我認為在商業環境中,實際上你將能夠接觸到我們目前甚至在今天所做的更廣泛的渠道。所以我認為這是一個區別。
I think the second difference is that what you can do from a commercial perspective will also look different. Remember today, we're under an EUA. And while we can do a lot of education, key things like sampling cannot be done in an EUA. So that's going to be an example of another difference that will happen post EUA. And then I think, finally, even if you think about consumer education, today, we've really limited ourselves to unbranded in sort of disease awareness education.
我認為第二個不同之處在於,從商業角度來看,你可以做的事情看起來也會有所不同。記住今天,我們處於 EUA 之下。雖然我們可以做很多教育,但像採樣這樣的關鍵事情不能在 EUA 中完成。因此,這將成為 EUA 之後發生的另一個差異的一個例子。然後我認為,最後,即使您考慮消費者教育,今天,我們確實將自己限制在無品牌的疾病意識教育中。
But again, in a commercial setting, you could support through branded education and talk a lot more about the product. And so all of these are things that actually Pfizer does and the commercial organization of Pfizer does really well. This is our sweet spot. So I think that we look forward to building on top of what the government has been doing, which has been really excellent, and building on top of that to do more and to support greater initiatives across the country.
但同樣,在商業環境中,您可以通過品牌教育提供支持,並更多地談論產品。所以所有這些都是輝瑞公司實際做的事情,輝瑞公司的商業組織做得非常好。這是我們的甜蜜點。因此,我認為我們期待在政府一直在做的事情的基礎上再接再厲,這真的很出色,並在此基礎上做更多事情並支持全國范圍內的更大舉措。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Angela, well said. What about TL1A, Mikael?
謝謝你,安吉拉,說得好。 TL1A 呢,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
Briefly, this is our internally discovered antibody against TL1A, remember the TNF super family that is associated with inflammatory diseases. Yes, we have consistent, robust efficacy for all-comer UC patients and very strong efficacy, consistent across the trial, for prospectively defined precision biomarker. Tolerability was very good. Now this is induction data. And later this year, we will have maintenance data. And as we get those dataset, we will decide about next step.
簡而言之,這是我們內部發現的針對 TL1A 的抗體,請記住與炎症性疾病相關的 TNF 超家族。是的,我們對所有 UC 患者都具有一致、穩健的療效,並且對於前瞻性定義的精確生物標誌物,在整個試驗中都具有非常強的療效。耐受性非常好。現在這是歸納數據。今年晚些時候,我們將獲得維護數據。當我們得到這些數據集時,我們將決定下一步。
Operator
Operator
Your next questions come from the line of Mohit Bansal with Wells Fargo.
您的下一個問題來自富國銀行的 Mohit Bansal。
Mohit Bansal - Senior Equity Analyst
Mohit Bansal - Senior Equity Analyst
And congrats on the early oral GLP-1 data, especially for once-daily. My question is how much incremental data we are going to see in September from the one you presented today? And also, how soon can you move this agent into bigger trials? And how do you see the biggest differentiation versus the oral semaglutide at this point?
並祝賀早期的口服 GLP-1 數據,尤其是每天一次。我的問題是,我們將在 9 月份從您今天介紹的數據中看到多少增量數據?此外,您多久可以將此代理轉移到更大的試驗中?在這一點上,您如何看待與口服索馬魯肽的最大區別?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Sure. Mikael, maybe also you take that question.
當然。 Mikael,也許你也接受這個問題。
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. We are very excited about this new dataset, 1532, that you will see at the EASD meeting in Stockholm in September. There will be additional data. And I think you will find Hba1c very encouraging, although this was a short study. I think compared to oral semaglutide, the differentiation is substantial. This is a true small molecule that can be given, it's a once-a-day, it's completely independent on fasting or meal concordance.
是的。我們對這個新的數據集 1532 感到非常興奮,您將在 9 月的斯德哥爾摩 EASD 會議上看到它。會有額外的數據。我認為您會發現 Hba1c 非常令人鼓舞,儘管這是一項簡短的研究。我認為與口服索馬魯肽相比,差異很大。這是一個可以給予的真正小分子,它是一天一次,它完全獨立於禁食或進餐一致性。
And I think you will be able to reach higher effects on both glucose as well as on weight reduction. As I reported now, we were almost at 100 mg per deciliter reduction over 4 to 6 weeks and 5 kilogram. And we haven't yet optimized the titration to even higher doses. So we are very encouraged of what we see. We're going to share with regulators soon our next trial set and move swiftly to allow us to pick the winner and the regimen for a potential Phase 3 study to come after the Phase 2b.
而且我認為您將能夠對葡萄糖和減輕體重產生更高的影響。正如我現在報導的那樣,在 4 到 6 周和 5 公斤的時間內,我們幾乎每分升減少 100 毫克。而且我們還沒有將滴定優化到更高的劑量。因此,我們對我們所看到的感到非常鼓舞。我們將很快與監管機構分享我們的下一個試驗組,並迅速採取行動,讓我們能夠選擇獲勝者和方案,以便在第 2b 階段之後進行潛在的第 3 階段研究。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Mikael. And also to add to that, this is, for us, clearly a high-priority project. We have a designation within the company what we call the Lightspeed Project, project of significant value to patients and, as a result, also significant economic value, where we give this designation. And so we move them with the speed of light. And we overinvest to make sure that we de-risk and we move fast. And I review personally on a biweekly -- on a bimonthly basis the progress of this program. So that is going to be one of them.
謝謝你,米凱爾。此外,對我們來說,這顯然是一個高度優先的項目。我們在公司內部有一個我們稱之為 Lightspeed 項目的名稱,該項目對患者俱有重要價值,因此也具有重要的經濟價值,我們給予此名稱。所以我們以光速移動它們。我們過度投資以確保我們降低風險并快速行動。我每兩週親自審查一次——每兩個月審查一次該計劃的進展情況。所以這將是其中之一。
Operator
Operator
Your next questions come from the line of Evan Seigerman with BMO Capital Markets.
您的下一個問題來自 BMO Capital Markets 的 Evan Seigerman。
Evan David Seigerman - MD & Senior BioPharma Research Analyst
Evan David Seigerman - MD & Senior BioPharma Research Analyst
Congrats on the progress. I would love for your perspective on the provision for Medicare to negotiate directly with manufacturers as a part of the now-coined Inflation Reduction Act that we have press reports reporting a deal between Manchin and Schumer. Well, kind of what's the potential long-term impact on your R&D and innovation?
祝賀進展。我很想听聽您對醫療保險直接與製造商進行談判的看法,這是現在創造的減少通貨膨脹法案的一部分,我們有新聞報導報導了曼欽和舒默之間的交易。那麼,對您的研發和創新有什麼潛在的長期影響?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you. I'm disappointed with what I'm reading in the newspapers. Of course, we can't know exactly what will happen because we have seen that this situation is very volatile. But everything that they are reporting, they are going to implement a price setting. In reality, it's not a price negotiation because they are forcing their will by implementing a 95% tax according to previous guidance. That will cause the industry significant. We estimate $270 billion over 10 years. There is a positive provision there that they are reducing the out-of-pocket cost for the patient. That's a significant one, but it's too little and too late.
謝謝你。我對我在報紙上看到的內容感到失望。當然,我們無法確切知道會發生什麼,因為我們已經看到這種情況非常不穩定。但是他們報告的所有內容,他們都將實施價格設定。實際上,這不是價格談判,因為他們是在按照之前的指導實施 95% 的稅收來強迫自己的意願。這將對行業造成重大影響。我們估計 10 年內將達到 2700 億美元。那裡有一個積極的規定,他們正在減少患者的自付費用。這很重要,但太少也太晚了。
They could do way more because that will cost 10% of the $270 billion that they're going to collect. They are basically not doing that to alleviate patients' cost because they could give all the money and then make significant, significant difference to the patient. They're just giving a part of that. And they want even to start it, if I understood well, from year 2025. So although the out-of-pocket is a very positive provision, but the [rest one] is a provision that I think will force the industry to reduce R&D if it goes the way that they are they are suggesting. So other than that, I don't have anything to add. We will wait to see how the -- what exactly in reality that means and we'll go from there.
他們可以做得更多,因為這將花費他們將收集的 2700 億美元中的 10%。他們這樣做基本上不是為了減輕患者的費用,因為他們可以付出所有的錢,然後對患者產生重大影響。他們只是給出了其中的一部分。如果我理解得很好,他們甚至想從 2025 年開始。因此,雖然自付費用是一項非常積極的規定,但我認為 [rest one] 是一項規定,將迫使行業減少研發如果它按照他們建議的方式進行。所以除此之外,我沒有什麼要補充的。我們將拭目以待——這究竟意味著什麼,我們將從那裡開始。
And also I want to say it is very disappointing that they are choosing to single out one industry. Everything in this bill, from what I understand, tax, all of that, that is affecting everyone. But then there are specific measures to affect only the pharma industry, particularly when we are out of a pandemic, where this industry has proven the value that brings to public health and to the global economy. We would be in a very different point in this global economy if we didn't have the investments in the thriving life sciences sector. And they are choosing to single out this industry. I think it's wrong. And I hope that reason will prevail when these discussions go to Congress.
而且我想說的是,他們選擇挑出一個行業非常令人失望。據我了解,該法案中的所有內容,稅收,所有這些都影響著每個人。但隨後有一些具體措施只影響製藥行業,特別是當我們擺脫大流行病時,該行業已經證明了為公共衛生和全球經濟帶來的價值。如果我們沒有在蓬勃發展的生命科學領域進行投資,我們將在這個全球經濟中處於一個非常不同的階段。他們選擇單挑這個行業。我認為這是錯誤的。我希望當這些討論提交國會時,這個理由將佔上風。
Operator
Operator
Your next questions come from the line of Louise Chen with Cantor Fitzgerald.
你的下一個問題來自於 Cantor Fitzgerald 的 Louise Chen。
Louise Alesandra Chen - Senior Research Analyst & MD
Louise Alesandra Chen - Senior Research Analyst & MD
Just curious if some of the setbacks that we have seen in the CD47 space changed your view on the market opportunity for your Trillium assets.
只是好奇我們在 CD47 領域看到的一些挫折是否改變了您對 Trillium 資產市場機會的看法。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. Why don't we go to William?
是的。我們為什麼不去找威廉?
William Pao - Chief Development Officer, Executive VP
William Pao - Chief Development Officer, Executive VP
Yes, sure. So thanks for the question, Louise. So we saw the news the other day. Internally, we remain confident in our program with Trillium. And we proceed with the programs that we are planning. And we'll let the data speak for itself when they come out.
是的,當然。所以謝謝你的問題,路易絲。所以我們前幾天看到了新聞。在內部,我們對 Trillium 的計劃仍然充滿信心。我們繼續我們正在計劃的項目。當數據出來時,我們會讓數據自己說話。
Operator
Operator
Your next question comes from the line of David Risinger with SVB Securities.
您的下一個問題來自 SVB 證券的 David Risinger。
David Reed Risinger - Senior MD
David Reed Risinger - Senior MD
Congratulations on the performance. I wanted to ask a little bit about VYNDAQEL and VYNDAMAX. The performance was below our and consensus expectations. If you could speak to that and also talk about the sequential prospects going forward, i.e., has the product peaked out in the U.S.? And how should we think about future prospects relative to the sales that you booked?
祝賀你的表現。我想問一些關於 VYNDAQEL 和 VYNDAMAX 的問題。業績低於我們和共識的預期。如果你能談到這一點並談論未來的連續前景,即該產品是否在美國達到頂峰?我們應該如何考慮與您預訂的銷售額相關的未來前景?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Well, thank you, David. Angela, what do you think?
好吧,謝謝你,大衛。安吉拉,你怎麼看?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Well, we continue to be really pleased with how VYNDAQEL is doing. If you look at just from a diagnosis perspective, quarter-over-quarter, year-over-year, we continue to do a really great job of effectively finding and identifying who the ATTR-CM patients are, diagnosing them and then bringing them on to therapies. So in this quarter, we have reached an all-time high of 40% diagnosis rate. And I think that this is well beyond what we thought we would be able to do in the time frame that we have had. So we continue to believe in the growth that this product has.
好吧,我們仍然對 VYNDAQEL 的表現感到非常滿意。如果您僅從診斷的角度來看,季度環比,同比增長,我們將繼續在有效地發現和識別 ATTR-CM 患者是誰、診斷他們然後將他們帶入治療方面做得非常出色到治療。因此,在本季度,我們的診斷率達到了 40% 的歷史新高。而且我認為這遠遠超出了我們認為在我們所擁有的時間範圍內能夠做到的事情。所以我們繼續相信這個產品的增長。
The real-world data that has been generated now and the overall survival benefits are really compelling. And the fact that we are the only product being able to demonstrate these benefits, I think, speaks well to how we'll continue to be able to build in this market despite competition that will arise. I think what you're referring to in terms of the impact and the expectations really is a one-time effect, and it was in Japan. And this was a very specific price decrease that was planned and driven by regulation.
現在生成的真實世界數據和總體生存收益確實令人信服。我認為,我們是唯一能夠展示這些優勢的產品,這一事實很好地說明了我們將如何繼續能夠在這個市場上建立,儘管將會出現競爭。我認為你所指的影響和期望確實是一次性的,而且是在日本。這是一個非常具體的價格下降,是由監管計劃和驅動的。
When VYNDAQEL was launched in Japan, again based on pricing regulation in the country that was specific to the country, it was a much higher price than any other country we had. And so by regulation again, it's the 75% price decrease that we're seeing is a function of that. But the underlying growth of VYNDAQEL in Japan is really strong. We had, just in the first half of 2022, 69% volume growth. We had 32% year-over-year of new patient starts. So hopefully, this gives you a sense that the net revenue impacts you see are, in fact, not a reflection of the demand and the true underlying demand, whether it's in the U.S. or ex U.S.
當 VYNDAQEL 在日本推出時,再次基於該國特定國家的定價規定,它的價格比我們擁有的任何其他國家都高得多。因此,再次通過監管,我們看到的 75% 的價格下降是其功能。但 VYNDAQEL 在日本的潛在增長非常強勁。就在 2022 年上半年,我們的銷量增長了 69%。我們有 32% 的新患者開始使用。因此,希望這能讓您感覺到,您看到的淨收入影響實際上並不能反映需求和真正的潛在需求,無論是在美國還是美國以外。
Operator
Operator
Your next question comes from the line of Tim Anderson with Wolfe Research.
您的下一個問題來自沃爾夫研究公司的蒂姆·安德森(Tim Anderson)。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
A question on your RSV vaccine. There doesn't seem to be anything but a brief mention of the program in the press release or the slides and really nothing in prepared remarks, but we have Phase 3 data results coming out very soon. I'm wondering why.
關於您的 RSV 疫苗的問題。除了在新聞稿或幻燈片中簡要提及該計劃外,似乎沒有任何其他內容,在準備好的評論中實際上沒有任何內容,但我們很快就會公佈第 3 階段的數據結果。我想知道為什麼。
But really, my main question is why you recently changed the primary endpoint in the Phase 3 trial, including downsizing of the trial? And that comes on top of a delay in readouts as announced earlier this year. And if I can slip one in on your quadrivalent mRNAs flu, when would we likely see results from your Phase 3 that you're starting up?
但實際上,我的主要問題是為什麼您最近更改了 3 期試驗的主要終點,包括縮小試驗規模?這是在今年早些時候宣布的讀數延遲之上的。如果我能在你的四價 mRNAs 流感中加入其中,我們什麼時候可能會看到你正在啟動的第 3 階段的結果?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you. Mikael, both questions go to you. I think the first question, I think, was for RSV, right?
謝謝你。 Mikael,這兩個問題都交給你了。我認為第一個問題是針對 RSV 的,對嗎?
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. We have made great progress in the RSV adult trial. As you know, we ran it through two different seasons in the Northern and Southern Hemisphere to make sure we had good patient experience and cases, seems looking good for a readout that will come soon. I remain very positive about RSV adult based on our Phase 2 challenge data that was stellar and the role that this particular antigen that we're targeting play. And as you know, we're the only one that are targeting the two forms of this pre-fusion.
是的。我們在 RSV 成人試驗中取得了很大進展。如您所知,我們在北半球和南半球運行了兩個不同的季節,以確保我們有良好的患者體驗和病例,看起來很適合即將到來的讀數。基於我們出色的第 2 階段挑戰數據以及我們所針對的這種特定抗原所發揮的作用,我仍然對 RSV 成人持非常積極的態度。如您所知,我們是唯一針對這種預融合的兩種形式的公司。
You also asked about modRNA flu. Yes, as Albert mentioned, we are going big here with an efficacy study. We are encouraged about the data we're seeing. We think it's a unique dataset. And we plan to soon embark on a Phase 3 after proper dialogue with regulators. Of course, this is an event trial. But if the season is robust, which you can never know, we would expect the Phase 3 to read out next year.
您還詢問了有關 modRNA 流感的問題。是的,正如 Albert 所提到的,我們將在這裡開展一項功效研究。我們對所看到的數據感到鼓舞。我們認為這是一個獨特的數據集。我們計劃在與監管機構進行適當對話後很快開始第三階段。當然,這是一個事件審判。但如果這個季節很強勁,你永遠不會知道,我們預計第三階段將在明年公佈。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Exactly. And also, I'm sorry if we gave the impression that RSV is not important to us, it's extremely important. If there is no better good news, this is why we didn't mention it much but still remains the very good news. But the previous studies were extremely strong and the current studies are progressing very well. So we have very high confidence, absent a surprise, that we will launch next year a very robust product both in adults and in maternal, the maternal, both studies are progressing very well.
確切地。而且,如果我們給人的印像是 RSV 對我們不重要,我很抱歉,它非常重要。如果沒有更好的好消息,這就是為什麼我們沒有過多提及但仍然是非常好的消息。但是之前的研究非常強大,目前的研究進展非常順利。因此,我們非常有信心,毫無意外地,我們將在明年推出一款非常強大的產品,無論是在成人中還是在孕產婦中,這兩項研究都進展順利。
Operator
Operator
Your next questions come from the line of Geoff Meacham from Bank of America.
您的下一個問題來自美國銀行的 Geoff Meacham。
Geoffrey Christopher Meacham - Research Analyst
Geoffrey Christopher Meacham - Research Analyst
Just had a couple on PAXLOVID real quick. Can you give us an update on the number of countries you're in contract discussions with? I'm just thinking relative to the start of the year. And then related, what's been the biggest contributor of supply expansion in 2Q? And when do you think you guys will be fully, fully normalized?
很快就在 PAXLOVID 上有了一對。你能告訴我們你正在與多少個國家進行合同討論嗎?我只是在考慮相對於年初的情況。然後相關的是,第二季度供應擴張的最大貢獻者是什麼?你認為你們什麼時候會完全、完全正常化?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Let's go to Angela for the number of countries and where we are with that.
讓我們去安吉拉那裡了解國家的數量以及我們在哪裡。
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Yes. So we are in contract with a significant number of countries at this point. Maybe I can talk about it from a dose perspective. So more than 35 million treatment courses have already been contracted with a number of countries. And this is what we publicly disclosed. There are additional doses that I can't talk about because either the country didn't want us to disclose them publicly or we're in the middle of negotiations with them. So I think to answer your question, since we last left off, we have made progress with our contracting.
是的。因此,我們目前與許多國家簽訂了合同。也許我可以從劑量的角度來談談。因此,已經與多個國家簽訂了超過 3500 萬個療程。這是我們公開披露的。還有一些我無法談論的額外劑量,因為要么該國不希望我們公開披露它們,要么我們正在與他們進行談判。所以我想回答你的問題,自從我們上次離開以來,我們的簽約取得了進展。
I think what's -- maybe what's more important to clarify is just that the approach that countries are taking to contract with us is just really different to where we were in COMIRNATY. In COMIRNATY, they were interested in securing large amounts of doses upfront. But that's, in fact, not the case here in PAXLOVID. And the reason being that, number one, they're being prudent with how they are ordering. And they are able to do that because they know that we have the manufacturing capacity and that we can pivot as we need. The countries are also trying to manage inventory and not to have too much aged product lying around. And so I think that this is what's driving the more smaller, more frequent contracting rather than big, big contracts that -- like you saw in COMIRNATY.
我認為——也許更重要的是要澄清的是,各國與我們簽訂合同的方法與我們在 COMIRNATY 中的情況完全不同。在 COMIRNATY 中,他們對預先獲得大量劑量感興趣。但事實上,PAXLOVID 並非如此。原因是,第一,他們對訂購方式持謹慎態度。他們之所以能夠做到這一點,是因為他們知道我們擁有製造能力,並且我們可以根據需要進行調整。這些國家也在努力管理庫存,不要讓太多陳舊的產品閒置。所以我認為這就是推動更小、更頻繁的合同而不是大合同的原因——就像你在 COMIRNATY 中看到的那樣。
The other thing I will also say is -- and the reason why I'm talking in doses rather than specific countries is because we're also working with super national organizations, who are acting on behalf of multiple countries. So think Global Fund, think UNICEF, these are, in addition to the bilaterals, are also important organizations who are helping us to supply and bring doses into the countries. So I think all in all, great progress. And I think you should expect to see that this is one of these things that will just keep inching away because of how countries want to manage the inventory and the supply.
我還要說的另一件事是——我之所以說劑量而不是具體國家,是因為我們還與代表多個國家的超級國家組織合作。所以想想全球基金,想想聯合國兒童基金會,除了雙邊機構之外,這些也是幫助我們向各國供應和運送劑量的重要組織。所以我認為總的來說,進步很大。而且我認為您應該期望看到,由於各國希望如何管理庫存和供應,這只是其中之一。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Angela. And also to -- because you had also a question on supplier ramp-up. We have done tremendous progress on that field. Actually, we have been able to reduce dramatically the lead time, so to how much time it's needed for manufacturing, and we have improved dramatically our yields. So supply is not an issue. Actually, we moved almost everything in-house now in terms of API and finished products.
謝謝你,安吉拉。還有——因為你還有一個關於供應商增加的問題。我們在該領域取得了巨大進展。實際上,我們已經能夠顯著減少交貨時間,從而減少製造所需的時間,並且我們已經顯著提高了產量。所以供應不是問題。實際上,我們現在幾乎所有東西都在內部轉移,包括 API 和成品。
Operator
Operator
Your next questions come from the line of Chris Schott with JPMorgan.
您的下一個問題來自摩根大通的 Chris Schott。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Just one follow-up on the PAXLOVID comments. As we move, I guess, from some of these large government orders that we saw with the U.S., et cetera, earlier this year to maybe these more kind of on-demand smaller contracts, how do we think about what the impact that has on pricing? Because I think you were giving some volume-based discounts before. And just help us -- I guess, think about kind of 2023 and beyond what pricing does for that business?
只是對 PAXLOVID 評論的一項後續行動。我猜,隨著我們的行動,從今年早些時候我們在美國等國看到的一些大型政府訂單到可能更多類型的按需小型合同,我們如何看待這對我們產生的影響價錢?因為我認為您之前提供了一些基於數量的折扣。只是幫助我們——我想,想想 2023 年及以後的定價對該業務有何影響?
And then kind of the bigger question I had was just on IBRANCE dynamics. I think you mentioned in the prepared remarks, you're seeing signs of a recovery for your business there. I'm just interested in how you kind of see the balance of just overall market dynamics relative to the competitive landscape with obviously one of your competitors with an adjuvant indication.
然後我遇到的更大的問題是關於 IBRANCE 的動態。我認為您在準備好的評論中提到,您在那裡看到了您的業務復甦的跡象。我只是對您如何看待整體市場動態相對於競爭格局的平衡感興趣,顯然您的競爭對手之一具有輔助適應症。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much. Chris, we do not provide, let's say, forward-looking projections on pricing. And particularly, every time I speak about pricing, it's becoming big news. So I want to make sure that we respect that. I know what you are asking. And I can give a very high-level answer. Clearly, we are providing special pricing when we are contracting very, very big quantities with governments. That's also the incentive for the government to buy big quantities because the price is really, really very attractive.
非常感謝。克里斯,比方說,我們不提供有關定價的前瞻性預測。特別是,每次我談到定價時,它都會成為大新聞。所以我想確保我們尊重這一點。我知道你在問什麼。我可以給出一個非常高級的答案。顯然,當我們與政府簽訂非常非常大的合同時,我們會提供特價。這也是政府大量購買的動力,因為價格真的非常非常有吸引力。
But if we move to a normal market, the prices would reflect both in vaccines and in antivirals, the prices of similar value, similar technology products that they are out there. And clearly, also when you move to private commercial markets, the complexities are getting way, way higher. We will need to go to single doses in the vaccines. So manufacturing complexities are very higher. We need to have distribution to small distribution centers, including physician offices. So all of that creates a very big complexity but also could be taken into consideration as we price our products at that time.
但是,如果我們轉向正常市場,價格將反映在疫苗和抗病毒藥物中,它們的價格相似,技術產品相似。顯然,當你轉向私人商業市場時,複雜性也越來越高。我們將需要接種單劑疫苗。因此製造複雜性非常高。我們需要分發到小型配送中心,包括醫生辦公室。因此,所有這些都造成了非常大的複雜性,但在我們當時為產品定價時也可以考慮在內。
And I want to emphasize that also those present significant opportunities for us. Because the open market, it is way more complex, way more diverse to have millions of customers rather than one or two. And this plays to our strengths in terms of having global presence or within the U.S., dramatic presence in every single territory of the country with thousands of people that they are calling physicians, hospitals, accounts, in payers' accounts, et cetera, et cetera. So it's something that if we see a turn into this market, also we will see us being able to compete more of a position of strength than now. As regards to IBRANCE, Angela?
我想強調的是,這些也為我們提供了重要的機會。因為開放市場,擁有數百萬客戶而不是一兩個客戶要復雜得多,也更加多樣化。這發揮了我們在全球或美國境內的優勢,在該國的每一個領土上都有成千上萬的人,他們稱他們為醫生、醫院、賬戶、付款人賬戶等等。 .因此,如果我們看到轉向這個市場,我們也會看到我們能夠比現在更有競爭力。關於 IBRANCE,安吉拉?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Sure. Well, as you say, the metastatic breast cancer CDK4/6 market is incredibly competitive yet. I will emphasize that IBRANCE continues to be the leading CDK4/6 inhibitor. In fact, we have a 74% market share across all patients in first-line therapy. And I think that this number has been pretty consistent because we talk about it every quarter. And I think it demonstrates just the tremendous experience that physicians and patients have and the confidence they have in IBRANCE despite new competition.
當然。好吧,正如您所說,轉移性乳腺癌 CDK4/6 市場的競爭非常激烈。我將強調 IBRANCE 仍然是領先的 CDK4/6 抑製劑。事實上,我們在一線治療的所有患者中擁有 74% 的市場份額。我認為這個數字非常一致,因為我們每個季度都在談論它。我認為這表明了醫生和患者擁有的豐富經驗以及他們對 IBRANCE 的信心,儘管有新的競爭。
The patient experience, the fact that we have real-world clinical evidence, all of this really adds to the confidence that we have in this brand. And even though IBRANCE is a mature brand, we do continue to see growth. And where the growth will come from are from the following places. You're going to see growth from the CDK class. You're going to see growth from the recovery of new patient starts, which, as you know, has not recovered to the levels prior to the pandemic as well as stabilization of the PAP through time when economic conditions improve.
患者體驗,我們擁有真實世界臨床證據的事實,所有這些確實增加了我們對這個品牌的信心。儘管 IBRANCE 是一個成熟的品牌,但我們確實會繼續看到增長。增長將來自以下幾個地方。您將看到 CDK 課程的增長。您將看到新患者開始恢復的增長,正如您所知,隨著經濟狀況的改善,新患者還沒有恢復到大流行之前的水平,以及人民行動黨的穩定。
And I actually want to make a special point of this class growth. Because therein lies, I think, a tremendous opportunity for all of us. Today -- well, last year this time, the CDK class was 48% in first-line metastatic breast cancer use. This quarter, it was 54%. So even though it's grown, it still means that the majority of the time, CDKs are not being used. And I think we, all of us in this class, really need to focus on this as the leading priority in helping to grow each of our brands but also to grow the class to impact patient outcome.
我實際上想對這個班級的成長提出一個特殊的觀點。因為我認為這對我們所有人來說都是一個巨大的機會。今天——嗯,去年這個時候,CDK 類在一線轉移性乳腺癌使用中佔 48%。本季度為 54%。因此,即使它已經增長,它仍然意味著大多數時候,CDK 沒有被使用。我認為我們,我們班上的所有人,真的需要把重點放在這作為幫助發展我們每個品牌的首要任務,同時也要發展班級以影響患者的結果。
Operator
Operator
Your next questions come from the line of Chris Shibutani with Goldman Sachs.
您的下一個問題來自高盛的 Chris Shibutani。
Chris Shibutani - Research Analyst
Chris Shibutani - Research Analyst
First, a quick word of welcome and appreciation to David for your proactive commentary on the phasing of revenues. It really mirrors what your predecessor had often fondly referred to as the rhythm of the numbers, very helpful to get insights on near-term factors that are generating push-pulls on those numbers. My question is on business development, however. And I'm not sure that Aamir has joined us.
首先,歡迎和感謝大衛對收入階段性的積極評論。它確實反映了您的前任經常親切地稱為數字的節奏,非常有助於深入了解對這些數字產生推拉的近期因素。但是,我的問題是關於業務發展的。我不確定 Aamir 是否加入了我們。
But perhaps if you could update us on your latest thoughts of the team in terms of how you're feeling about areas of focus, particularly in view of recent broader commentary, for instance, from the FTC, taking a look at competitive dynamics there. And then secondly, as you reflect upon the overall ecosystem and the receptivity, given things like lowered, relatively speaking, biotech valuations, are you sensing any shifts or trends or changes in the mindset of potential targets, partners, acquirers?
但是,也許您可以向我們更新您對團隊的最新想法,了解您對重點領域的感受,特別是考慮到最近更廣泛的評論,例如來自 FTC 的評論,看看那裡的競爭動態。其次,當你反思整個生態系統和接受度時,考慮到生物技術估值相對較低,你是否感覺到潛在目標、合作夥伴、收購者心態的任何轉變或趨勢或變化?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much. Aamir is here, and he will be happy to speak about it. Aamir?
非常感謝。阿米爾來了,他會很樂意談論這件事。阿米爾?
Aamir Malik - Executive VP & Chief Business Innovation Officer
Aamir Malik - Executive VP & Chief Business Innovation Officer
Chris, thank you for the question. Let me just start with your specific FTC point. I think we've demonstrated a very strong track record of shepherding our transactions to date through the regulatory process. And that's been largely built on having just a close, successful, constructive and collaborative relationships with regulatory bodies globally. In addition, our business development focus, and I'll recap our priorities in a second, is focused on how do we use our unique abilities to translate emerging science into breakthrough medicines.
克里斯,謝謝你的問題。讓我從您的特定 FTC 點開始。我認為,迄今為止,我們在通過監管程序引導我們的交易方面表現出了非常出色的記錄。這在很大程度上建立在與全球監管機構建立密切、成功、建設性和協作的關係之上。此外,我們的業務發展重點(我將在稍後回顧我們的優先事項)側重於我們如何利用我們獨特的能力將新興科學轉化為突破性藥物。
So most of the deals that we do are pro-patient and they're pro-innovation. So we're confident that we can continue to advance our BD strategies in a successful way. We've been very clear that our goal is to add $25 billion of risk-adjusted revenue by 2030. And I think we are making very good progress against that. This year, you saw our transaction with ReViral and subsequently with Biohaven, which, respectively, we believe have the potential to add $1.5 billion and $6 billion in peak sales to our business. And this was on the back of a very active 2021.
因此,我們所做的大多數交易都是有利於耐心的,而且有利於創新。因此,我們有信心繼續以成功的方式推進我們的 BD 戰略。我們非常清楚,我們的目標是到 2030 年增加 250 億美元的風險調整收入。我認為我們在這方面取得了很好的進展。今年,您看到了我們與 ReViral 以及隨後與 Biohaven 的交易,我們認為這分別有可能為我們的業務增加 15 億美元和 60 億美元的峰值銷售額。這是在一個非常活躍的 2021 年的背後。
And going forward, we're leaving very few stones unturned when we look at opportunities. And our focus is going to be consistent. It's on scientific substrate that has a potential breakthrough for patients, deals that accelerate our top line growth in the back half of the decade and then opportunities where we can add substantial value, whether that's through our scientific chops and/or our commercial capabilities. And we're going to be very open to deal structures. And we've said before, we're also going to be agnostic to size.
展望未來,當我們尋找機會時,我們將不遺餘力。我們的重點將是一致的。它在科學基礎上對患者有潛在的突破,在本世紀後半期加速我們的收入增長的交易,然後是我們可以增加實質性價值的機會,無論是通過我們的科學印章和/或我們的商業能力。我們將對交易結構非常開放。我們之前已經說過,我們也將不知道大小。
We've been clear about the fact that cost synergy-driven deals are not where our focus is going to be. And we're going to be extremely disciplined. I think we're very excited about the opportunities that are ahead of us and the flexibility that our balance sheet gives us to pursue those. And on your question on valuation fluctuations, those market valuation fluctuations are not going to drive our BD strategy. We're going to remain focused on fundamentals in the way that I described.
我們已經很清楚,成本協同驅動的交易不是我們關注的重點。我們將非常自律。我認為我們對擺在我們面前的機會以及我們的資產負債表賦予我們追求這些機會的靈活性感到非常興奮。關於你關於估值波動的問題,這些市場估值波動不會推動我們的 BD 戰略。我們將按照我所描述的方式繼續關注基本面。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you. And it is very important when we are aiming very high to also be able, at the same time, to be disciplined. Disciplined in valuing the science and paying the right price for the right science so that the capital that we will dispose will be maximized in producing value for patients and the shareholders. So we go very big, $25 billion. But as we have proven, we are very, very disciplined in how we're allocating our capital. And we will continue doing that.
謝謝你。當我們的目標非常高時,同時能夠遵守紀律是非常重要的。有紀律地重視科學,為正確的科學支付正確的價格,使我們將處置的資本最大化地為患者和股東創造價值。所以我們做得很大,250億美元。但正如我們已經證明的那樣,我們在如何分配資本方面非常、非常自律。我們將繼續這樣做。
Operator
Operator
Your next questions come from the line of Andrew Baum with Citi.
您的下一個問題來自花旗銀行的 Andrew Baum。
Andrew Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
A two-part question, please. Your former Head of Vaccines is now ensconced at your competitor, GSK. When he top lined the recent positive Phase 3 data for their RSV vaccine candidate, which is adjuvanted, an observation he made was he stressed the same level of efficacy in the older patient cohort than in the younger patient cohorts. It's possible to imagine that this may be uniquely related to the adjuvant that they have, given the immunosenescence of the aging population of T cells. Given your vaccine does not have an adjuvant background, is that a concern, particularly over follow -- longer years follow-up?
一個兩部分的問題,請。你的前疫苗主管現在就職於你的競爭對手葛蘭素史克。當他為他們的 RSV 候選疫苗(輔以佐劑)列出最近的陽性 3 期數據時,他的觀察結果是,他強調老年患者隊列的療效水平與年輕患者隊列相同。考慮到 T 細胞群體的免疫衰老,可以想像這可能與他們所擁有的佐劑有獨特的關係。鑑於您的疫苗沒有佐劑背景,這是一個問題,特別是在後續 - 更長年的後續行動中?
And then second, just following up on a question on IBRANCE. Could you talk to your Arvinas compound, ARV-471? We come up with market shares which are materially lower than yours. But whatever the number is, it's clearly reducing quite significantly as competition builds momentum in the market. How are you thinking about, as you transition this drug into Phase 3, both what combinations you're going to run and what are you going to use as the control arm for the combination of a SERD plus a CDK4/6?
其次,只是跟進有關 IBRANCE 的問題。你能和你的 Arvinas 化合物 ARV-471 談談嗎?我們提出的市場份額遠低於您的市場份額。但無論數字是多少,隨著競爭在市場上形成勢頭,它顯然正在顯著減少。當您將這種藥物過渡到第 3 階段時,您如何考慮您將運行哪些組合以及您將使用什麼作為 SERD 和 CDK4/6 組合的控制臂?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Andrew. Just to make a correction, it was not the Head of our Vaccines that joined, it was another member of the Vaccines team but by no means was the head. Let's move to Mikael.
謝謝你,安德魯。只是為了更正一下,加入的不是我們疫苗的負責人,而是疫苗團隊的另一名成員,但絕不是負責人。讓我們轉向 Mikael。
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 am very optimistic about our RSV vaccine construct. We have seen high immune titer that are critical for the vaccine across all ages. In fact, we are the only one that have showed cross-strain A and B for RSV, the very high titers, which differ between all the vaccines, including the one that you mentioned because they mainly measure crosser activity from A to B strain. So that was supported also by our challenge data that looked formidable.
是的。我對我們的 RSV 疫苗結構非常樂觀。我們已經看到對所有年齡段的疫苗都至關重要的高免疫滴度。事實上,我們是唯一一個顯示出 RSV 的交叉株 A 和 B,非常高的滴度,這在所有疫苗之間都不同,包括你提到的那個,因為它們主要測量從 A 到 B 株的交叉活性。因此,我們看起來很強大的挑戰數據也支持了這一點。
So while nobody can predict exactly the outcome of studies and comparing one study to another, we remain very bullish that our bivalent vaccine should stand out in performance and in tolerability. Please note some of the adjuvants, including the one that you referred to, often associated with somewhat unpleasant side effects. And that was one part of our differentiation to achieve with a bivalent, very high data and with best-in-class tolerability.
因此,雖然沒有人能準確預測研究結果並將一項研究與另一項研究進行比較,但我們仍然非常看好我們的二價疫苗應該在性能和耐受性方面脫穎而出。請注意一些佐劑,包括您提到的那一種,通常與一些令人不快的副作用有關。這是我們通過二價、非常高的數據和一流的耐受性實現差異化的一部分。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
And what about IBRANCE?
那麼 IBRANCE 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
The ARV-471, I can only speak about the science here that we see that drug being active in several lines as by itself, best-in-class estrogen receptor, PROTAC. And we are going to set up our studies in a patient population which contains many estrogen receptor mutants, which often are poorly managed by the current available fulvestrant or other SERDs. And we think this is a unique opportunity.
ARV-471,我只能在這裡談論科學,我們看到這種藥物在幾個方面都有活性,就像它本身一樣,一流的雌激素受體 PROTAC。我們將在包含許多雌激素受體突變體的患者群體中開展我們的研究,這些突變體通常由當前可用的氟維司群或其他 SERD 管理不善。我們認為這是一個獨特的機會。
And number two, the drug seemed to combine very well with our own CDK4/6 drugs. And we think it could advance into early metastatic lines. And possible over time, even to early breast cancer, maybe they are combined with our CDK4. So we have very high hopes for that class of drugs, ARV-471 combined with our pipeline.
第二,該藥物似乎與我們自己的 CDK4/6 藥物結合得很好。我們認為它可以進入早期轉移線。並且可能隨著時間的推移,甚至是早期乳腺癌,也許它們與我們的 CDK4 相結合。所以我們對這類藥物寄予厚望,ARV-471與我們的管道相結合。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you. Anything to add, William?
謝謝你。有什麼要補充的嗎,威廉?
William Pao - Chief Development Officer, Executive VP
William Pao - Chief Development Officer, Executive VP
Yes, I would just add, as you mentioned, Mikael, the preclinical data shows that the ER degradation could be superior to selective estrogen receptor degraders. And so we're very excited about this potential to be superior to SERDs that are being developed.
是的,我只想補充,正如你提到的,Mikael,臨床前數據表明,ER 降解可能優於選擇性雌激素受體降解劑。因此,我們對這種優於正在開發的 SERD 的潛力感到非常興奮。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, from your lips to God's ears. Also, I want to add on the RSV because it's the second question that came and maybe gave the impression that we are not very hot on it. We are extremely hot on it. Clearly, a very important product for us, clearly a very important project for GSK. So there will be a lot of speculation. Maybe the other one will do that or maybe the other thing will do this.
謝謝你,從你的嘴唇到上帝的耳朵。另外,我想補充一下 RSV,因為這是第二個問題,可能給人的印像是我們對它不是很熱情。我們對此非常熱心。顯然,對我們來說是一個非常重要的產品,對 GSK 來說顯然是一個非常重要的項目。所以會有很多猜測。也許另一個會這樣做,或者另一件事會這樣做。
I think data will speak on themselves. With the totality of data available, so far that I have seen, we have high reasons to believe we are better. But you never know before the end of the trials. But right now, with all, looks like we have a very, very strong profile with all the data that I have seen so far. We are waiting a lot with a lot of excitement to unblind the data and see the realities. And then of course, the best will win. Let's move now to Steve.
我認為數據會自己說話。就目前我所看到的所有可用數據而言,我們有充分的理由相信我們做得更好。但在試驗結束之前你永遠不會知道。但是現在,總而言之,看起來我們對我迄今為止所看到的所有數據都擁有非常非常強大的個人資料。我們非常興奮地等待著揭開數據的盲點並看到現實。然後當然,最好的將獲勝。現在讓我們轉向史蒂夫。
Operator
Operator
Your next question comes from Steve Scala with Cowen.
您的下一個問題來自 Steve Scala 和 Cowen。
Stephen Michael Scala - MD & Senior Research Analyst
Stephen Michael Scala - MD & Senior Research Analyst
I would just like to understand more deeply Pfizer's thinking on factor XI. I could think of three possibilities. First, Pfizer believes there is simply no room to improve upon ELIQUIS. Second, Pfizer believes factor XI could be very useful, but you haven't found the ideal candidate. Or third, Pfizer is not sure the jury is still out. Any thoughts?
我只是想更深入地了解輝瑞對因子XI的思考。我能想到三種可能性。首先,輝瑞認為 ELIQUIS 根本沒有改進的餘地。其次,輝瑞認為因子 XI 可能非常有用,但您還沒有找到理想的候選者。或者第三,輝瑞不確定陪審團是否仍然存在。有什麼想法嗎?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
I think we have answered it before. And maybe Mikael also can give some color because it's a very, very good question. But bottom line is we are looking for science that it could provide hope that we can have something better than ELIQUIS. And we haven't found it yet. So that's the reality. According to our opinion, there is not much maturity right now to overcome the brilliant -- the very good profile of ELIQUIS. Mikael, anything to add? It's as simple that.
我想我們之前已經回答過了。也許 Mikael 也可以提供一些顏色,因為這是一個非常非常好的問題。但底線是我們正在尋找科學,它可以提供希望,我們可以擁有比 ELIQUIS 更好的東西。而且我們還沒有找到。所以這就是現實。根據我們的觀點,目前還沒有多少成熟可以克服輝煌——ELIQUIS 非常好的形象。 Mikael,有什麼要補充的嗎?就這麼簡單。
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
Mikael Dolsten - Chief Scientific Officer and President of Worldwide Research, Development & Medical
I think you said it very well. In the atrial field, the platelet inhibitor and [ASA] are or are going to be genericized. ELIQUIS and rivaroxaban, great drugs, ELIQUIS being a market leader, factor X inhibitor, or by the time factor XI comes to market, close to or already genericized. So the room for an expensive drug in an area with these many great treatments, that requires tremendously high R&D expense coming off the patients that have gone through multiple other grade drugs. For us, it doesn't look like the best area to deploy capital. We always wish others would like for the benefit of patients.
我覺得你說得很好。在心房領域,血小板抑製劑和 [ASA] 正在或將要被仿製。 ELIQUIS 和利伐沙班,偉大的藥物,ELIQUIS 是市場領導者,因子 X 抑製劑,或者當因子 XI 進入市場時,接近或已經仿製。因此,在一個擁有許多偉大治療方法的領域,一種昂貴藥物的空間,需要從已經使用多種其他級別藥物的患者身上獲得極高的研發費用。對我們來說,這似乎不是部署資本的最佳領域。我們總希望別人也一樣,為患者造福。
Operator
Operator
Your final question will come from the line of Elliott Bosco with UBS.
您的最後一個問題將來自瑞銀的 Elliott Bosco。
Elliott Andrew Bosco - Associate Analyst
Elliott Andrew Bosco - Associate Analyst
This is Elliott Bosco from UBS on for Colin Bristow. Just a few on PAXLOVID, you mentioned countries needing to manage older supply. Do you think that current PAXLOVID use trends will result in excess inventory versus what has been contractually purchased? And additionally, could you comment on the recent Codexis retainer arrangement and how we should think about that with regard to a 2023 PAXLOVID demand?
這是來自瑞銀的 Elliott Bosco 代表 Colin Bristow。在 PAXLOVID 上,您提到了需要管理舊供應的國家。您是否認為當前 PAXLOVID 的使用趨勢會導致庫存超出合同購買的數量?此外,您能否評論一下最近的 Codexis 保留安排,以及我們應該如何看待 2023 PAXLOVID 需求?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Angela?
安吉拉?
Angela Hwang - Group President of Biopharmaceuticals Group
Angela Hwang - Group President of Biopharmaceuticals Group
Sure. No, I think that the way we are manufacturing PAXLOVID with, of course, great knowledge from our prior experiences with COMIRNATY but also in terms of our negotiations and discussions with countries is actually allowing us to do supply planning very well. So we are manufacturing as we need and according to the contracts and according to the demand that the countries are providing us. So I think we're doing that on a -- in a very prudent and in a very -- in a prudent and an effective way. So I didn't -- we didn't -- your second question?
當然。不,我認為我們製造 PAXLOVID 的方式當然是從我們之前與 COMIRNATY 的經驗以及我們與國家的談判和討論方面的豐富知識,實際上使我們能夠很好地進行供應計劃。因此,我們按照我們的需要、根據合同以及各國向我們提供的需求進行製造。所以我認為我們正在以一種非常謹慎和非常 - 以一種謹慎和有效的方式來做這件事。所以我沒有——我們沒有——你的第二個問題?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes, what was the second question? I'm not sure.
是的,第二個問題是什麼?我不確定。
Christopher J. Stevo - Senior VP & Chief IR Officer
Christopher J. Stevo - Senior VP & Chief IR Officer
Codexis, the enzyme supplier for...
Codexis,酶的供應商...
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes, it was the -- do you want to -- I did refer to it, but maybe also you can reiterate it, David.
是的,這是--你想不想--我確實提到了它,但也許你也可以重申一下,大衛。
David M. Denton - CFO, Executive VP
David M. Denton - CFO, Executive VP
Yes, I think Albert indicated this earlier in his remarks is that, in fact, over the last several quarters, we've improved our manufacturing process, reduced the cycle time and importantly improved the yield from an output perspective. So therefore, we don't need as much raw materials and API to produce the same amount of finished goods. And then finally, we've actually invested in our network to make sure that we can actually produce some API as well. So we're in good shape.
是的,我認為 Albert 在他之前的講話中指出,事實上,在過去幾個季度中,我們改進了製造工藝,縮短了周期時間,重要的是從產出的角度提高了產量。因此,我們不需要那麼多原材料和 API 來生產相同數量的成品。最後,我們實際上已經對我們的網絡進行了投資,以確保我們實際上也可以生成一些 API。所以我們的狀態很好。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
What I said before, we are moving most of it now because we could weigh faster than what we anticipated, move it inside. So that creates some cancellations of raw materials to some external suppliers. I'm sorry about that. I think that was the last question.
我之前說過,我們現在正在移動大部分,因為我們可以比我們預期的更快稱重,把它移到裡面。因此,這會導致一些外部供應商取消一些原材料。對此我很抱歉。我想這是最後一個問題。
Let me close with a few takeaways. The first one, as you see, we continue to deliver strong operational performance. We increased our full year '22 operational financial forecast while maintaining a challenging foreign exchange environment. So I think few companies likely will be able to do that. We believe we are well positioned not only to maintain but also to grow both our commercial and scientific leadership in the battle against COVID-19. It will be, for us, a very important focus. And we believe that the medical need will be there for the years to come. That's why we're investing so heavily.
讓我以一些要點結束。第一個,如您所見,我們繼續提供強勁的運營業績。我們提高了 22 年全年運營財務預測,同時保持具有挑戰性的外匯環境。所以我認為很少有公司能夠做到這一點。我們相信,在與 COVID-19 的戰鬥中,我們不僅可以保持而且可以增強我們在商業和科學方面的領導地位。對我們來說,這將是一個非常重要的焦點。我們相信醫療需求將在未來幾年存在。這就是為什麼我們如此大力投資的原因。
We continue focus on driving long-term shareholder returns by remaining very disciplined both on our operations and our incremental capital deployment. You saw even in this quarter. But even more, we are squeezing our administrative expenses, our SI&A is going down and then we reinvest in R&D because we have programs that we are starting that we feel is a very good return on our investment. And we continue to advance our internal scientific pipeline while executing against our previously announced plans to potentially add at least $25 billion of risk-adjusted revenues through business development opportunities from 2030 top line.
我們繼續專注於推動長期股東回報,在我們的運營和增量資本部署方面保持非常自律。你甚至在本季度也看到了。但更重要的是,我們正在壓縮我們的管理費用,我們的 SI&A 正在下降,然後我們再投資於研發,因為我們正在啟動一些我們認為投資回報非常好的項目。我們繼續推進我們的內部科學管道,同時執行我們先前宣布的計劃,從 2030 年開始,通過業務發展機會可能增加至少 250 億美元的風險調整收入。
Thus, I want very quickly to see that these results in R&D are yielding results. Just to mention a few of the potential approvals and launches that we are going to have in the next few months. CIBINQO, we expect to launch the adolescence next year. And of course, next year will be the real first year where we expect to have full access for this drug. We expect to launch next year, RSV maternal. We expect to launch next year, RSV adults. We expect to launch next year, Prevnar 20 for pediatrics. We expect to launch next year elranatamab for triple-class refractory myeloma. We expect to launch next year ritlecitinib for atopic -- for alopecia areata.
因此,我希望很快看到這些研發成果正在產生成果。僅提及我們將在未來幾個月內獲得的一些潛在批准和發布。 CIBINQO,我們預計明年將推出青春期。當然,明年將是我們期望完全獲得這種藥物的真正第一年。我們預計明年推出RSV母體。我們預計明年推出成人 RSV。我們預計明年推出用於兒科的 Prevnar 20。我們預計明年將推出用於三級難治性骨髓瘤的 elranatamab。我們預計明年將推出用於特應性斑禿的 ritlecitinib。
We expect to launch next year, pentavalent meningococcal vaccine. We expect next year, TALAPRO for prostate cancer metastatic castration patients. We expect to launch -- or we did already MYFEMBREE for endometriosis. And then a little bit later, we expect maybe this in '23 or beginning of '24, DMD and flu mRNA. So it is -- this is the organic. I'm not referring to the Biohaven NURTEC that is coming and to other molecules, I'm referring mainly to the organically developed pipeline assets.
我們預計明年推出五價腦膜炎球菌疫苗。我們預計明年,TALAPRO 將用於前列腺癌轉移性去勢患者。我們希望推出——或者我們已經推出了用於子宮內膜異位症的 MYFEMBREE。然後稍晚一點,我們預計這可能會在 23 年或 24 年初,DMD 和流感 mRNA 出現。所以它是 - 這是有機的。我不是指即將到來的 Biohaven NURTEC 和其他分子,我主要指的是有機開發的管道資產。
I don't think that much of that has been a factor into what some of the analysts are projecting. That's why I'm emphasizing them so that they can pay a little bit more attention. Those are very high probability of success, the ones that I mentioned. They are not in the pocket clearly, all of them. And some clearly might not make it to the [finish] (corrected by company after the call) line. But we believe they are seriously de-risked, all of that.
我不認為這在很大程度上是一些分析師預測的一個因素。這就是為什麼我要強調它們,以便他們可以更加關注。這些都是非常高的成功概率,我提到的那些。它們都沒有清楚地放在口袋裡。有些人顯然可能無法到達[完成](由公司在通話後更正)行。但我們相信他們已經嚴重降低了風險,所有這些。
So with that in mind, I'm really looking forward to have a 6% CAGR by '25 in our business as we promised in 2019. In fact, year-to-date, we are at 6%, excluding BD and excluding COVID. And I think we will do that by 2025. We will maintain this 6% CAGR. And we'll do more by BD that we are right now implementing. So I think we have a very good growth prospect. And we will maintain our leadership in COVID. Thank you very, very much for your interest. And for those that didn't have summer vacations yet, enjoy your summer vacations.
因此,考慮到這一點,我真的很期待像我們在 2019 年承諾的那樣,到 25 年,我們的業務複合年增長率為 6%。事實上,今年迄今為止,我們的複合年增長率為 6%,不包括 BD 和 COVID .我認為我們將在 2025 年之前做到這一點。我們將保持 6% 的複合年增長率。我們將通過 BD 做更多我們現在正在實施的工作。所以我認為我們有一個非常好的增長前景。我們將保持我們在 COVID 領域的領導地位。非常非常感謝您的關注。對於那些還沒有暑假的人來說,享受你的暑假吧。
Operator
Operator
Ladies and gentlemen, this concludes Pfizer's Second Quarter 2022 Earnings Conference Call. You may now disconnect.
女士們先生們,輝瑞公司 2022 年第二季度收益電話會議到此結束。您現在可以斷開連接。