輝瑞 (PFE) 2023 Q2 法說會逐字稿

內容摘要

輝瑞公佈了穩健的第二季度財務業績,非 COVID-19 收入與去年同期相比增長了 5%。由於 PAXLOVID 和 COMIRNATY 的預期收入下降,總收入下降了 53%。

輝瑞正在朝著在 18 個月內推出 19 種新產品或適應症的目標取得進展。該公司預計在 2023 年下半年將有 6 個新產品獲得批准,並有 6 個新產品上市。輝瑞的 COVID-19 產品已產生利潤,使該公司能夠投資收購。

該公司承認 COVID-19 產品的需求預測存在不確定性,但預計到今年年底會更加明確。輝瑞還準備根據各種收入情況調整其成本基礎。對 Seagen 的收購計劃正在進行中,輝瑞因其建立信任的努力和工作環境而獲得讚譽。該公司正在努力恢復其位於北卡羅來納州落基山的工廠,該工廠因龍捲風而遭受嚴重損壞。

輝瑞對其戰略仍然充滿信心,並致力於實現其長期目標。他們還在各個治療領域開發創新療法。該公司討論了共同決策對疫苗接種、成本削減以及減肥藥物潛力的影響。

他們對自己的競爭優勢表示信心,並討論了自己的資本配置策略。輝瑞高管回答了有關成本計劃、颶風對其設施的影響以及收入增長的問題。他們對自己的長期前景充滿信心,並討論了各種藥物項目的計劃。

該公司對開發有效的流感 mRNA 疫苗的能力充滿信心,並討論了對 Seagen 的收購。他們對增長潛力和整合挑戰感到興奮。 DMD 基因治療項目正在取得進展,公司對其實現長期增長和股東價值的能力充滿信心。

完整原文

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

  • Operator

    Operator

  • Good day, everyone, and welcome to Pfizer's Second Quarter 2023 Earnings Conference Call. Today's call is being recorded.

    大家好,歡迎參加輝瑞 2023 年第二季財報電話會議。今天的通話正在錄音。

  • At this time, I would like to turn the call over to Mr. Chris Stevo, Senior Vice President and Chief Investor Relations Officer. Please go ahead, sir.

    現在,我想將電話轉給資深副總裁兼首席投資者關係長 Chris Stevo 先生。先生,請繼續。

  • Christopher J. Stevo - Senior VP & Chief IR Officer

    Christopher J. Stevo - Senior VP & Chief IR Officer

  • Thank you, Chelsea. Good morning. Welcome to Pfizer's second quarter earnings call. I'm joined today by Dr. Albert Bourla, our Chairman and CEO; Dave Denton, our CFO; Dr. Mikael Dolsten, Chief Scientific Officer and President, Pfizer Research and Development. Joining for the Q&A session, we also have Angela Hwang, Chief Commercial Officer and President, Global Biopharmaceutical Business; Aamir Malik, our Chief Business Innovation Officer; Dr. Chris Boshoff, our Chief Oncology Research and Development Officer; and Doug Lankler, our General Counsel.

    謝謝你,切爾西。早安.歡迎參加輝瑞第二季財報電話會議。今天與我一起出席的還有我們的董事長兼執行長 Albert Bourla 博士;我們的財務長 Dave Denton;輝瑞研發部首席科學官兼總裁 Mikael Dolsten 博士。參加問答環節的還有首席商務官兼全球生物製藥業務總裁 Angela Hwang;我們的首席商業創新官 Aamir Malik;我們的首席腫瘤學研究與開發官 Chris Boshoff 博士;以及我們的總法律顧問Doug Lankler。

  • Before we begin the call, I want to remind you of some logistical items. The materials for this call and other earnings-related materials are on the Investor Relations section of Pfizer.com, and of course, my favorite, our forward-looking statements. Please see our forward-looking statements disclaimer on Slide 3 and additional information regarding these statements, and our non-GAAP financial measures is available on our earnings release in our SEC forms 10-K and 10-Q under Risk Factors and Forward-Looking Information and factors that may affect future results. 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 these statements.

    在我們開始通話之前,我想提醒您一些後勤事項。本次電話會議的資料和其他收益相關資料均位於 Pfizer.com 的「投資者關係」部分,當然還有我最喜歡的我們的前瞻性聲明。請參閱幻燈片 3 上的前瞻性聲明免責聲明和有關這些聲明的其他信息,我們的非 GAAP 財務指標可在我們的 SEC 表格 10-K 和 10-Q 中的收益報告中的“風險因素和前瞻性信息以及可能影響未來結果的因素”下找到。電話會議中的前瞻性陳述受重大風險和不確定性的影響,僅代表電話會議最初日期的觀點,我們不承擔更新或修改任何這些陳述的義務。

  • With that, I will turn the call over to Albert.

    說完這些,我將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, and thank you for joining us today. Our second quarter financial results were solid and in line with our expectations. Non-COVID-19 revenues grew 5% operationally compared to the year ago quarter. Total revenue declined 53% operationally, primarily due to the anticipated revenue declines in both PAXLOVID and COMIRNATY. Even with these declines, our COVID-19 portfolio remains a significant contributor to the business with more than $1.6 billion in combined revenue during this quarter. Of course, our patient impact data are equally important because patients are the reason we exist. Through the first 6 months of the year, more than 356 million patients around the world were treated with our medicines and vaccines.

    謝謝你,克里斯。大家好,感謝大家今天加入我們。我們第二季的財務表現穩健,符合我們的預期。與去年同期相比,非 COVID-19 業務營運收入成長了 5%。總營運收入下降了 53%,主要原因是預計 PAXLOVID 和 COMIRNATY 的收入都會下降。即使出現這些下降,我們的 COVID-19 產品組合仍然是業務的重要貢獻者,本季的總收入超過 16 億美元。當然,我們的患者影響數據同樣重要,因為患者是我們存在的原因。今年前六個月,全球有超過 3.56 億名患者接受了我們的藥物和疫苗治療。

  • We continue to make progress towards our goal of executing an unprecedented number of launches of new products or indications. In fact, Pfizer is more than halfway of its goal of launching 19 new products or indications in 18 months' time. In addition to the 6 approvals and 5 launches that occurred prior to 2023, we have 6 approvals and 4 launches in the first 6 months of 2023. For the second half of 2023, we expect 6 additional approvals and 6 additional launches, including the 2 launches that occurred in July.

    我們正繼續朝著推出數量空前的新產品或新適應症的目標邁進。事實上,輝瑞公司已經完成了在 18 個月內推出 19 種新產品或新適應症的目標的一半以上。除了 2023 年之前獲得的 6 項批准和 5 次發射外,我們在 2023 年前 6 個月還有 6 項批准和 4 次發射。對於 2023 年下半年,我們預計還會有 6 項批准和 6 次發射,其中包括 7 月的 2 次發射。

  • Then in 2024, we expect 1 approval and 4 launches which, if approved and recommended, would raise the total to 19 new launches in approximately 18 months. As you can see in this chart, for this year's launches, we expect the revenue contribution to occur largely in the second half of 2023 because the first half launches occurred late in the second quarter. And then in 2024, with the additional impact of next year's expected launches, we anticipate an even greater total contribution for our 19 launches. It is important to note that 18 of the 19 potential launches have been largely de-risked from a technical perspective at this point, with the only 1 remaining being our RNA flu candidate.

    然後到 2024 年,我們預計將有 1 項批准和 4 項發射,如果獲得批准和推薦,那麼在大約 18 個月內總數將增加到 19 項新發射。正如您在該圖表中所看到的,對於今年的發布,我們預計收入貢獻將主要發生在 2023 年下半年,因為上半年的發布發生在第二季末。然後到 2024 年,加上明年預計發射的額外影響,我們預計 19 次發射的總貢獻將更大。值得注意的是,從技術角度來看,19 種潛在發射藥物中有 18 種目前已基本消除風險,僅剩的一種是我們的 RNA 流感候選藥物。

  • Equally encouraging is that our pipeline is expected to contribute -- continue generating breakthrough treatments and vaccines long after the 19 we have been discussing. We recently reported milestones from several exciting pipeline candidates with the potential to be significant future value drivers. These include: Phase 3 data from marstacimab, a novel antibody being studied for the treatment of hemophilia A and B; regulatory filing acceptance of our hemophilia B gene therapy candidate; the publication in the New England Journal of Medicine of Phase 2 results for our vaccine candidate for maternal immunization against Group B streptococcus; and first-in-human data from our pipeline of potential next-generation breast cancer treatments, including our novel CDK4, CDK2 and KAT6 inhibitors.

    同樣令人鼓舞的是,我們的產品線有望做出貢獻——在我們討論的 19 個疫苗之後很長一段時間內繼續產生突破性的治療方法和疫苗。我們最近報告了幾個令人興奮的候選項目的里程碑,這些項目有可能成為未來重要的價值驅動因素。其中包括:正在研究用於治療血友病 A 和 B 的新型抗體 marstacimab 的 3 期數據;我們的血友病 B 基因治療候選藥物的監管備案獲得接受;在《新英格蘭醫學雜誌》上發表了我們的針對 B 型鏈球菌的母體免疫候選疫苗的第 2 階段結果;以及我們潛在的人類藥物治療的首次癌症。

  • Now I would like to provide some commentary on our COVID-19 portfolio. As you all know, during the pandemic, Pfizer demonstrated impressively the power of our research and manufacturing capabilities by bringing to the world the first and most widely used vaccine and oral treatment for COVID-19. These scientific breakthroughs have played a significant role in bringing the global health crisis under control, and we are very proud of our contribution. The profits that these products have generated today have enabled us to invest in acquiring Arena, ReViral, Biohaven and Global Blood Therapeutics, which together, we expect to contribute approximately $10 billion of revenues in year 2030.

    現在,我想對我們的 COVID-19 投資組合提供一些評論。大家知道,在此次疫情期間,輝瑞公司向全世界帶來了第一種、使用最為廣泛的新冠肺炎疫苗和口服治療藥物,令人印象深刻地展示了我們強大的研發和生產能力。這些科學突破為控制全球衛生危機發揮了重要作用,我們為自己的貢獻感到非常自豪。這些產品如今產生的利潤使我們能夠投資收購 Arena、ReViral、Biohaven 和 Global Blood Therapeutics,我們預計這些公司到 2030 年將共同貢獻約 100 億美元的收入。

  • In fact, the acquisitions of Biohaven and Global Blood Therapeutics are already contributing to our operational growth, while the acquisition of Arena is expected to start generating revenues toward the end of this year. We also remain very excited about our planned acquisition of Seagen, which if approved, is expected to contribute more than $10 billion in 2030 revenues.

    事實上,對 Biohaven 和 Global Blood Therapeutics 的收購已經為我們的營運成長做出了貢獻,而對 Arena 的收購預計將在今年年底開始產生收入。我們也對收購 Seagen 的計畫感到非常興奮,如果獲得批准,預計將在 2030 年貢獻超過 100 億美元的收入。

  • As a result of the positive momentum of our non-COVID-19 revenues and more importantly, the success of our COVID-19 portfolio, Pfizer's overall revenues have increased exponentially compared with our 2019 revenues, pro forma for the divestitures of Upjohn and our Consumer business. This allowed us to increase investments in R&D and SI&A to support this new revenue base and our expected new product launches.

    由於我們非 COVID-19 收入的積極勢頭,更重要的是我們 COVID-19 產品組合的成功,輝瑞的整體收入與 2019 年的收入相比呈指數級增長,這是對 Upjohn 和我們的消費者業務剝離的預測。這使我們能夠增加對研發和 SI&A 的投資,以支持這項新的收入基礎和我們預期的新產品發布。

  • The increased investments we are making in R&D and SI&A this year were sized based on certain revenue assumptions we made in January for both our COVID-19 and non-COVID-19 products. These assumptions also were incorporated in our 2023 financial guidance. Clearly, there is a higher level of uncertainty regarding the demand projections for our COVID-19 products than for the rest of our business. For example, in January, we shared our expectation that approximately 100 million doses of COVID-19 would be administered in the U.S. this year, of which we estimated Pfizer to capture 60% market share. In the first 6 months of 2023, 12.4 million doses were administered in the U.S. While the 12.4 million doses are behind our earlier projections, our market share for COVID-19 is ahead of our previous expectations at 65%.

    我們今年在研發和 SI&A 方面增加的投資是基於我們 1 月針對 COVID-19 和非 COVID-19 產品所做的某些收入假設而確定的。這些假設也納入了我們 2023 年的財務指引中。顯然,我們對 COVID-19 產品的需求預測的不確定性程度高於我們其他業務的需求預測。例如,今年 1 月,我們曾預計今年美國將接種約 1 億劑 COVID-19 疫苗,其中輝瑞將佔 60% 的市佔率。 2023 年頭 6 個月,美國共接種了 1,240 萬劑疫苗。雖然 1,240 萬劑疫苗接種數量低於我們先前的預測,但我們在 COVID-19 領域的市佔率高於我們先前的預期,達到 65%。

  • However, the vast majority of respiratory vaccinations happened during the fall and winter respiratory disease season, which starts in September, and we expect COVID-19 vaccinations to follow this pattern going forward. The uncertainty of the exact timing of COMIRNATY commercialization was largely removed with the decision by the FDA and CDC to request a change in the composition of the vaccine to address the Omicron XBB.1.5 strain. We believe this will allow us to commercialize the vaccine in September, assuming the updated vaccines are approved and available by the end of August, of course.

    然而,絕大多數呼吸道疫苗接種都是在 9 月開始的秋冬季呼吸道疾病季節進行的,我們預計未來 COVID-19 疫苗接種將遵循這一模式。隨著 FDA 和 CDC 決定要求改變疫苗成分以應對 Omicron XBB.1.5 株,COMIRNATY 商業化具體時間的不確定性在很大程度上消除了。我們相信,這將使我們能夠在 9 月將疫苗商業化,當然,前提是更新後的疫苗獲得批准並在 8 月底上市。

  • In the European Union, the uncertainty regarding the vaccine's revenue contributions for '23 and beyond was removed when we renegotiated successfully our long-term agreement. This agreement spread the agreed volumes over 4 years. And while it puts pressure on this year's volumes, we believe it also provides longer-term revenue certainty in this important market.

    在歐盟,當我們成功重新談判長期協議時,關於疫苗對23年及以後的收入貢獻的不確定性就消除了。該協議將約定的數量分四年進行。雖然這給今年的銷售帶來壓力,但我們相信這也為這個重要市場帶來了長期收入確定性。

  • Similar to what we are experiencing with the vaccine, the second half of the year will play a bigger role in informing our expectations for the long-term demand of PAXLOVID, the utilization of which follows very closely the COVID-19 infection rates. We expect a new COVID-19 wave to start in the U.S. this fall, and this expectation is supported by the increase in infection rates we are already seeing. Obviously, the severity of disease and people's desire for treatment also will be factors, as will the ongoing dialogue with the U.S. government regarding when we will transition to a commercial model for PAXLOVID. These are the uncertainties.

    與疫苗的情況類似,今年下半年將在我們對 PAXLOVID 長期需求的預期中發揮更大的作用,PAXLOVID 的使用率與 COVID-19 感染率密切相關。我們預計今年秋天美國將出現新一波新冠肺炎疫情,而我們已經看到的感染率上升也支持了這個預期。顯然,疾病的嚴重程度和人們對治療的渴望也是影響因素,與美國政府就何時過渡到 PAXLOVID 商業模式進行的持續對話也是影響因素。這些都是不確定因素。

  • We are acutely aware that all these uncertainties are making it difficult to project the future revenues of Pfizer in this area and largely Pfizer, and also affecting our stock price as a result. The good news is we will have much more clarity and certainty regarding how our COVID-19 products will perform in the commercial market by the time we report our third quarter financial results. And we expect the uncertainties to be largely eliminated by the end of the year. This is because we expect the vaccination and treatment rates from the upcoming respiratory disease season to be a reliable predictor of trends in subsequent years, with some potential upside, of course, if a combination flu and COVID-19 vaccine is brought to market in the future.

    我們敏銳地意識到,所有這些不確定性使得我們難以預測輝瑞公司在該領域以及整個輝瑞的未來收入,也因此影響了我們的股價。好消息是,當我們報告第三季財務表現時,我們將對我們的 COVID-19 產品在商業市場上的表現更加清晰和確定。我們預計到今年年底不確定性將基本消除。這是因為我們預計即將到來的呼吸道疾病季節的疫苗接種和治療率將成為未來幾年趨勢的可靠預測指標,當然,如果未來流感和 COVID-19 聯合疫苗推向市場,還具有一些潛在的上升空間。

  • Additionally, by that point, the timing of transitioning to full commercialization of both COMIRNATY and PAXLOVID should become clear. Despite this uncertainty, we'll continue to invest in our COVID-19 portfolio this year, in advance of the upcoming respiratory disease season. This is very important. But given the uncertainty, we are also preparing to have the ability to adjust our 2024 total cost base to align with various future COVID-19 disease -- revenue scenarios. In fact, we've already identified specific areas where we can make adjustments, primarily within our COVID-19 cost base, if demand comes in lower than expected. Dave will provide more details during his remarks.

    此外,到那時,COMIRNATY 和 PAXLOVID 全面商業化的過渡時機應該會變得清晰。儘管存在這種不確定性,但我們今年仍將繼續投資於我們的 COVID-19 投資組合,以迎接即將到來的呼吸道疾病季節。這非常重要。但考慮到不確定性,我們也準備調整 2024 年的總成本基礎,以適應未來各種 COVID-19 疾病的收入情境。事實上,如果需求低於預期,我們已經確定了可以進行調整的具體領域,主要是在我們的 COVID-19 成本基礎內。戴夫將在發言中提供更多細節。

  • Next, I wanted to share a few quick updates of our planned acquisition of Seagen, which we believe will be a major driver of our future success. Seagen's shareholders recently overwhelmingly approved the planned acquisition, and we have already raised most of the external financing needed to fund the transaction. We also continue to work closely with regulators, including the Federal Trade Commission and the European Commission. In the meantime, our integration planning continues, which will allow us to hit the ground running following an anticipated close later in 2023 or early in 2024, subject to the satisfaction of customary closing conditions.

    接下來,我想分享一些我們計劃收購 Seagen 的最新進展,我們相信這將是我們未來成功的主要驅動力。 Seagen 的股東最近以壓倒性多數批准了該收購計劃,而且我們已經籌集了交易所需的大部分外部融資。我們也繼續與監管機構密切合作,包括聯邦貿易委員會和歐盟委員會。同時,我們的整合規劃仍在繼續,這將使我們能夠在滿足慣例成交條件的情況下,於 2023 年末或 2024 年初預計完成交易後立即開始工作。

  • Last week, we announced that Chris Boshoff has joined Pfizer's Executive Leadership eam as Chief Oncology Research and Development Officer and Executive Vice President, reporting directly to me. In this role, Chris will lead a new end-to-end Oncology R&D organization and be the single point of accountability for the entire oncology pipeline from discovery to early- and late-phase clinical development. This is similar to the structure we currently have in place for our Vaccines R&D organization, which has proven to be very productive.

    上週,我們宣布克里斯·博肖夫 (Chris Boshoff) 加入輝瑞執行領導團隊,擔任首席腫瘤學研發官兼執行副總裁,直接向我匯報。在這個職位上,克里斯將領導一個新的端到端腫瘤學研發組織,並成為從發現到早期和晚期臨床開發的整個腫瘤學流程的唯一責任人。這與我們目前疫苗研發組織的結構類似,事實證明非常有效率。

  • Pfizer and Seagen serve a common vision to deliver life-saving treatments for people living with cancer, which is why I'm so pleased that after closing, Chris' Oncology leadership team will include talented, purpose-driven and highly productive leaders from both companies. And we made already announcements about the people that are joining Chris' leadership team. We believe this new structure will help further accelerate the delivery of cancer therapies, which is critical because in the battle against cancer, time is life.

    輝瑞和 Seagen 有著共同的願景,那就是為癌症患者提供拯救生命的治療,這就是為什麼我很高興在交易完成後,Chris 的腫瘤學領導團隊將包括兩家公司的才華橫溢、目標明確、高效的領導者。我們已經宣布了加入克里斯領導團隊的人員名單。我們相信這種新結構將有助於進一步加速癌症治療的實施,這至關重要,因為在對抗癌症的鬥爭中,時間就是生命。

  • At Pfizer, one of core business principles is the belief that trust is everything. I'm proud to share that in recent months, we have received some wonderful accolades that speak to the trust we are building with external stakeholders. We were named one of the '23-'24 Best Companies to Work For by U.S. News & World Report. We were listed in Newsweek's List of America's Greatest Workplaces 2023. For the third year in a row, Pfizer has earned a top 100 score in the 2023 Disability Equality Index. And our own Rady Johnson received the Disability:IN '23 Executive Sponsor of the Year Award at the National Conference in July. And lastly, our PGS site in Ascoli, Italy is being recognized by the United Nations for the Welcome Award - Working for Refugee Integration. These recognitions are very important because they strengthen the unprecedented brand equity that Pfizer built during the COVID-19 pandemic.

    在輝瑞公司,核心經營原則之一就是堅信信任就是一切。我很自豪地告訴大家,近幾個月來,我們獲得了一些非常好的讚譽,這證明了我們與外部利害關係人之間建立的信任。我們被《美國新聞與世界報道》評選為‘23-’24 年度最佳工作公司之一。我們被《新聞週刊》列入 2023 年美國最佳工作場所名單。輝瑞連續第三年在 2023 年殘障平等指數中獲得前 100 名。我們自己的 Rady Johnson 在 7 月的全國會議上獲得了 Disability:IN '23 年度執行贊助商獎。最後,我們位於義大利阿斯科利的 PGS 站點榮獲聯合國「歡迎獎-致力於難民融合」。這些認可非常重要,因為它們增強了輝瑞在新冠肺炎疫情期間建立的前所未有的品牌資產。

  • Before I hand it over to Dave, I want to quickly comment on the situation at our facility in Rocky Mount, North Carolina. First, all of us at Pfizer were relieved that no colleagues were seriously injured when the tornado struck. That said, our facility sustained substantial damage as did the neighborhoods where many of our colleagues live, unfortunately. The local leadership team has done an incredible job responding to this devastating event. And we are proceeding with both urgency and caution to determine the best way to get the site back online as quickly as possible so as to minimize any impact on patients. Of course, we are also taking steps to ensure the continued safety of our colleagues and contractors, which remains our top priority.

    在將其交給戴夫之前,我想快速評論一下我們位於北卡羅來納州洛基山的工廠的情況。首先,輝瑞公司的所有人都感到欣慰,因為龍捲風襲擊時沒有同事受到嚴重傷害。儘管如此,不幸的是,我們的設施以及許多同事居住的社區都遭受了嚴重損害。當地領導團隊在應對這一災難性事件方面做出了出色的工作。我們正在緊急而謹慎地採取行動,尋找讓網站盡快恢復運作的最佳方法,以盡量減少對患者的影響。當然,我們也在採取措施確保同事和承包商的持續安全,這仍然是我們的首要任務。

  • And with that, I will now turn it over to Dave, and after Dave, Mikael will provide an update on our R&D pipeline. Dave?

    現在,我將把時間交給 Dave,在 Dave 之後,Mikael 將提供有關我們研發管道的最新進展。戴夫?

  • David M. Denton - CFO & Executive VP

    David M. Denton - CFO & Executive VP

  • Thank you, Albert, and good morning to everyone. Over the past 24 months, Pfizer has made important investments to position it squarely on track to achieve profitable and sustainable growth, particularly in the back half of this decade. We have strategically invested to expand our commercial portfolio and our late-stage pipeline, strengthened our market launch capabilities and enhanced innovation through internal R&D and business development actions. These deliberate efforts continue to solidify Pfizer's ability to overcome upcoming LOEs and drive sustainable revenue growth, all while enhancing long-term shareholder value.

    謝謝你,阿爾伯特,大家早安。在過去 24 個月中,輝瑞進行了重要投資,確保公司能夠實現盈利和可持續成長,尤其是在本世紀後半期。我們進行了策略性投資,以擴大我們的商業組合和後期產品線,增強我們的市場發布能力,並透過內部研發和業務發展行動增強創新。這些深思熟慮的努力將繼續鞏固輝瑞克服即將到來的 LOE 和推動永續收入成長的能力,同時提高長期股東價值。

  • To further support our long-term growth objectives, we are executing a capital allocation strategy designed to effectively deploy our cash. Our strategy is focused on 3 main pillars: first is reinvesting in our business; second is growing our dividends over time; and finally, making value-enhancing share repurchases. In the first half of 2023 alone, we've invested $5.2 billion in internal R&D, returned $4.6 billion to shareholders via our quarterly dividend and allocated approximately $43 billion towards the proposed acquisition of Seagen. During the second quarter, Pfizer successfully completed a $31 billion unsecured debt offering across 8 tranches. The net proceeds of this debt offering will be used to substantially fund the Seagen acquisition. The new debt carried a weighted average yield of 4.93% and a weighted average maturity of 16.3 years, consistent with our expectations.

    為了進一步支持我們的長期成長目標,我們正在執行旨在有效部署現金的資本配置策略。我們的策略集中在三大支柱上:首先是對我們的業務進行再投資;第二是隨著時間的推移增加我們的股息;最後,進行增值股票回購。光是 2023 年上半年,我們就在內部研發上投資了 52 億美元,透過季度股息向股東返還了 46 億美元,並向擬議的 Seagen 收購案撥款約 430 億美元。第二季度,輝瑞成功完成了 8 個階段共 310 億美元的無擔保債務發行。此次債務發行的淨收益將主要用於資助 Seagen 的收購。新債券的加權平均收益率為 4.93%,加權平均期限為 16.3 年,與我們的預期一致。

  • On a full year run rate basis, the annual financing cost associated with the acquisition is expected to be nearly $2 billion. With the completion now of this debt offering, the company is positioned to close the Seagen acquisition immediately upon post-regulatory approvals. While we plan to continue investing in our business, we expect to delever our capital structure following the closing of the Seagen transaction. As we delever, it is our expectation to return to a more balanced capital allocation strategy, inclusive of share repurchases.

    以全年運轉率計算,此次收購相關的年度融資成本預計將接近 20 億美元。隨著此次債務發行的完成,該公司將在獲得監管部門批准後立即完成對 Seagen 的收購。雖然我們計劃繼續投資我們的業務,但我們預計在 Seagen 交易完成後將降低我們的資本結構。隨著我們去槓桿,我們期望回歸更均衡的資本配置策略,包括股票回購。

  • Now with that, let me briefly cover a few highlights of our quarterly financial performance. As Albert said, our Q2 results were solid and in line with our expectations from both the top and a bottom line perspective, albeit slightly better than EPS consensus. As expected in our guidance, our overall Q2 revenue declined 53% operationally. The contraction in revenue was driven by the anticipated decline in both PAXLOVID and COMIRNATY sales. We expect these products to transition to a commercial market in the second half of this year. Our operational revenue growth, excluding our COVID products was in line with expectations at 5% versus Q2 of LY, with strong contributions from the inclusion of both NURTEC and Oxbryta as well as the continued growth from the VYNDAQEL family.

    現在,讓我簡要介紹一下我們季度財務業績的一些亮點。正如阿爾伯特所說,我們的第二季業績穩健,符合我們對頂線和底線角度的預期,儘管略好於每股盈餘預期。正如我們的預期,我們第二季的整體營運收入下降了 53%。收入收縮是由於 PAXLOVID 和 COMIRNATY 銷售額預計會下降。我們預計這些產品將在今年下半年進入商業市場。不包括 COVID 產品,我們的營業收入成長與去年第二季相比符合預期,為 5%,這得益於 NURTEC 和 Oxbryta 的加入以及 VYNDAQEL 家族的持續成長。

  • During Q2, adjusted SI&A expenses were $3.4 billion and grew 20% operationally versus LY. We continue to invest in support of our upcoming launches and grow our recently acquired products. While it's clear that these near-term investments are dampening our current profitability levels, we are laser-focused on maximizing the longer-term performance of these products.

    第二季度,調整後的 SI&A 費用為 34 億美元,與 LY 相比營運成長了 20%。我們將繼續投資支持即將推出的產品並發展我們最近收購的產品。雖然這些短期投資顯然正在削弱我們目前的獲利水平,但我們仍專注於最大限度地提高這些產品的長期表現。

  • Now moving to the bottom line, reported diluted earnings per share this quarter declined by 77% to $0.41, while Adjusted diluted earnings per share of $0.67 declined 65% on an operational basis. Earnings compressed at a greater rate than revenues, primarily due to the steep and anticipated contraction in PAXLOVID sales during the quarter. Once again, foreign exchange movements continue to unfavorably impact our results, reducing second quarter revenues by approximately $280 million or 1% and adjusted diluted earnings per share by $0.05 or 2% compared to last year.

    現在來看看底線,本季報告的每股攤薄收益下降 77% 至 0.41 美元,而調整後的每股攤薄收益為 0.67 美元,按營運基礎下降 65%。收益的壓縮速度快於收入,主要原因是本季 PAXLOVID 銷售額預計將大幅萎縮。外匯波動再次對我們的業績產生不利影響,導致第二季度營收與去年相比減少約 2.8 億美元或 1%,調整後每股攤薄收益減少 0.05 美元或 2%。

  • Now that we are at the halfway point of our 2023 financial plan, I'd like to take a moment to reflect on how we are executing across our business while navigating within an incredibly unique and dynamic environment. As a management team, we remain committed to transparency and sharing our assessment of the evolving marketplace, given the magnitude of launches, the ongoing shifting nature of the COVID landscape and the continued integration of acquired assets.

    現在,我們已經完成了 2023 年財務計畫的一半,我想花點時間反思一下,在一個極其獨特和充滿活力的環境中,我們如何在整個業務中執行。作為管理團隊,考慮到新產品發布的規模、COVID 情況的持續變化以及收購資產的持續整合,我們將繼續致力於保持透明度並分享我們對不斷變化的市場的評估。

  • Let me begin by elaborating on our full year '23 financial guidance. We are narrowing our expectations for revenues to between $67 billion and $70 billion and maintaining guidance for Adjusted diluted earnings per share of $3.25 to $3.45 for the full year. For our more durable and predictable non-COVID revenues, we are updating our guidance range to 6% to 8% operational revenue growth. From a launch timing standpoint, I'll point out that the majority of our 2023 launches are anticipated to occur in the second half of 2023, and our commercialization schedule remains materially unchanged. As a company, we always strive to achieve the highest revenue level possible while maintaining a realistic view of the key input that inform our outlook.

    首先,讓我詳細說明一下我們 23 年全年的財務指導。我們將營收預期縮小至 670 億美元至 700 億美元之間,並維持全年調整後每股攤薄收益 3.25 美元至 3.45 美元的預期。對於我們更持久、更可預測的非 COVID 收入,我們將指導範圍更新為 6% 至 8% 的營運收入成長。從發佈時間的角度來看,我要指出的是,我們預計 2023 年的大部分發布將在 2023 年下半年進行,我們的商業化計畫基本上保持不變。作為一家公司,我們始終努力實現最高的收入水平,同時對影響我們前景的關鍵投入保持現實的認識。

  • Regarding RSV for older adults, the shared decision-making recommendation by ACIP is likely to slow its near-term uptake in the U.S. In addition, the recent approval of TALZENNA in the U.S. results in a more narrow patient population than originally planned. These factors, coupled with the impact of the damaged Rocky Mount manufacturing facility presents near-term revenue challenges. However, we expect positive revenue momentum as we exit 2023 and head in 2024. And importantly, the long-term outlook for our non-COVID business remains intact relative to our 2030 ambitions.

    對於老年人的 RSV 治療,ACIP 的共享決策建議可能會減緩其在美國短期內的推廣速度。此外,TALZENNA 在美國最近獲得批准,導致患者群體比原計劃的要小。這些因素,再加上洛基山製造工廠受損的影響,為近期的收入帶來了挑戰。然而,我們預計,在 2023 年即將結束、2024 年即將到來之際,收入將呈現積極的勢頭。更重要的是,相對於我們 2030 年的目標,我們非新冠疫情業務的長期前景仍然完好無損。

  • Turning now to our less predictable and more variable COVID portfolio. Year-to-date, we have booked slightly over 40% of the $21.5 billion full year revenue forecast for both COMIRNATY and PAXLOVID with the important fall vaccination and respiratory infection season ahead of us. We are acutely aware that COVID demand depends on many evolving market variables, making the range of potential revenue outcomes increasingly large and difficult to predict with certainty. These variables include the overall level of vaccination and infection rates, the speed of drawdown in government inventory levels and the mutating nature of the virus itself, just to name a few.

    現在來談談我們不太可預測且變化更大的 COVID 投資組合。年初至今,由於重要的秋季疫苗接種和呼吸道感染季節即將到來,我們為 COMIRNATY 和 PAXLOVID 預定了略高於 215 億美元全年收入預測的 40% 的金額。我們敏銳地意識到,COVID 的需求取決於許多不斷變化的市場變量,這使得潛在收入結果的範圍越來越大且難以確定地預測。這些變數包括整體疫苗接種水準和感染率、政府庫存水準下降的速度以及病毒本身的變異性質,等等。

  • In the interest of public health and with the important fall season ahead of us, we are maintaining our COVID revenue outlook for the year while continuing to invest largely on a variable expense basis to support our COVID products in 2023. These variable investments are important to support our efforts to reach as many patients as possible, helping to ensure that the most at-risk individuals are both vaccinated and treated while maintaining our leading market share. We are proud of what we have achieved through the COVID portfolio, and this has allowed the company to invest in support of its growth agenda for the back half of this decade. Our visibility into future COVID revenues and demands should improve throughout the remainder of 2023 as we gain clarity on a more typical annual run rate.

    為了公眾健康的利益,並且鑑於即將到來的重要秋季,我們維持今年的 COVID 收入預期,同時繼續以可變費用為基礎進行大量投資,以支持我們在 2023 年的 COVID 產品。這些可變投資對於支持我們努力覆蓋盡可能多的患者非常重要,有助於確保最危險的人群接種疫苗並接受治療,同時保持我們領先的市場份額。我們為透過 COVID 投資組合所取得的成就感到自豪,這使得公司能夠進行投資以支持本世紀後半期的成長計畫。隨著我們對更典型的年運行率有了更清晰的了解,我們對未來 COVID 收入和需求的可見性應該會在 2023 年剩餘時間內得到改善。

  • We are well aware that our 2023 profit outlook is currently being dampened by incremental cost in support of our launches as well as higher R&D investments aligned with the company's current revenue base. We remain committed to both defending and growing our overall level of profitability. As Albert mentioned earlier, we expect this fall's performance of our COVID-19 products to help us more effectively forecast future sales performance. To that end, if our COVID-19 revenues are less than what we have assumed, we are prepared to launch an enterprise-wide cost improvement program aligned with the longer-term revenue projections for our business. This program will be designed to support our objective of growing our operating profit margin and we'd expect to begin to yield results in 2024. And we look forward to sharing the specific details of this program in our upcoming earnings call.

    我們清楚地知道,我們 2023 年的利潤前景目前正受到支持產品發布的增量成本以及與公司當前收入基礎相一致的更高研發投資的影響。我們將繼續致力於維護和提高我們的整體獲利水準。正如阿爾伯特之前提到的,我們預計今年秋季我們的 COVID-19 產品的表現將幫助我們更有效地預測未來的銷售表現。為此,如果我們的 COVID-19 收入低於我們的預期,我們準備啟動一項與我們業務的長期收入預測一致的企業範圍的成本改進計劃。該計劃旨在支持我們提高營業利潤率的目標,我們預計將在 2024 年開始產生成果。我們期待在即將召開的財報電話會議上分享該計劃的具體細節。

  • In closing, this is an extraordinary time for Pfizer. Our confidence and our commitment to our strategy and to achieving our 2030 goals is unwavering. We will continue to focus our efforts to drive growth while enhancing long-term shareholder value.

    最後,對輝瑞來說,這是一個非凡的時期。我們對我們的策略和實現2030年目標的信心和承諾是堅定不移的。我們將繼續集中努力推動成長,同時提高長期股東價值。

  • And with that, let me now turn it over to Mikael.

    現在,讓我將話題交給米凱爾 (Mikael)。

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • Thank you, Dave. Today, I will provide updates on a few different therapeutic focus areas, starting with breast cancer. We are working to deliver the next wave of innovative therapies for estrogen receptor-positive breast cancer. The pillars of this strategy are threefold: establishing our investigational CDK4 inhibitor as a next-generation cell cycle therapy backbone, establishing vepdegestrant as the next-generation endocrine therapy backbone; and establishing novel mechanisms like our investigational CDK2 inhibitor and KAT6 inhibitor candidate as next-gen combination partners to enhance efficacy.

    謝謝你,戴夫。今天,我將提供幾個不同治療重點領域的最新進展,首先是乳癌。我們正在致力於為雌激素受體陽性乳癌提供下一波創新療法。這項策略的支柱有三個面向:將我們正在研究的 CDK4 抑制劑確立為下一代細胞週期治療的骨幹,將 vepdegestrant 確立為下一代內分泌治療的骨幹;並建立新的機制,如我們正在研究的 CDK2 抑制劑和 KAT6 候選抑制劑作為下一代組合夥伴來增強療效。

  • Our clinical strategy entails first, developing assets for the metastatic setting, in which IBRANCE is currently the leader and unmet need is high, followed by an opportunity to expand to earlier-stage breast cancer, including the CDK4/6-naive population and adjuvant or neoadjuvant settings.

    我們的臨床策略首先是開發針對轉移性癌症的治療藥物,目前 IBRANCE 在該領域處於領先地位,且未滿足的需求很高,其次是擴展到早期乳癌的機會,包括 CDK4/6 初治人群和輔助或新輔助治療環境。

  • Data presented at ASCO from 3 key investigational medicines from our next-gen portfolio demonstrated antitumor activity heavily pretreated populations for patients with breast cancer. As a reminder, the majority of hormone receptor positive breast cancers express low CDK6, while CDK4 is likely to be a major cell cycle driver. We have seen that CDK4/6 inhibition can lead to neutropenia, which requires more frequent blood test monitoring, mostly driven by CDK6 inhibition. Across the CDK4/6 inhibitor class, approximately 30% to 60% of patients experience severe neutropenia.

    我們在 ASCO 上公佈的來自我們下一代產品組合的 3 種關鍵研究藥物的數據證明了對乳腺癌患者進行大量預處理後具有抗腫瘤活性。需要提醒的是,大多數荷爾蒙受體陽性乳癌表達低 CDK6,而 CDK4 可能是主要的細胞週期驅動因子。我們已經看到,CDK4/6 抑制可導致中性粒細胞減少症,這需要更頻繁的血液檢查監測,這主要是由 CDK6 抑制引起的。在 CDK4/6 抑制劑類別中,約 30% 至 60% 的患者會出現嚴重的嗜中性白血球減少症。

  • On the left, in a Phase 1 dose escalation study in patients with hormone receptor-positive HER2-negative breast cancer, all of whom have previously received a CDK4/6 inhibitor, treatment with our CDK4 inhibitor in combination with endocrine therapy resulted in a confirmed objective response rate of 29%, clinical benefit response rate of 52% and a median progression-free survival of nearly 25 weeks. The combination was well tolerated, which may enable maximum CDK4 inhibition. We are actively planning the Phase III randomized study.

    左側為針對荷爾蒙受體陽性 HER2 陰性乳癌患者(所有患者均曾接受過 CDK4/6 抑制劑治療)的 I 期劑量遞增研究中,使用我們的 CDK4 抑制劑合併內分泌療法治療的確認客觀緩解率為 29%,臨床受益緩解率為 52%,中位無惡化存活期為近 25 週。此組合耐受性良好,可能實現最大程度的 CDK4 抑制。我們正在積極籌劃第三期隨機研究。

  • In addition, I'd like to highlight encouraging data from the Phase 1 dose escalation study of our novel CDK2 inhibitor, which showed monotherapy activity, including confirmed partial responses in breast cancer patients who had previously received a CDK4/6 inhibitor. Also, durable confirmed clinical responses were observed in a Phase I trial of our novel KAT6 inhibitor as a monotherapy and in combination with endocrine therapy in heavily pretreated patients with breast cancer.

    此外,我想強調我們新型 CDK2 抑制劑的第 1 階段劑量遞增研究的令人鼓舞的數據,該研究顯示出單一療法活性,包括對先前接受過 CDK4/6 抑制劑治療的乳癌患者確認的部分反應。此外,在我們新型 KAT6 抑制劑作為單一療法和與內分泌療法聯合治療接受大量治療的乳癌患者的 I 期試驗中觀察到了持久的確認臨床反應。

  • Turning now to blood cancer. ELREXFIO, also known as elranatamab, subject to regulatory approval, is expected to be the anchor of an anticipated multibillion-dollar franchise. An FDA decision for the potential first indication in the triple-class relapsed or refractory multiple myeloma population is expected this year, and we continue to advance the MagnetisMM clinical programs to expand into earlier lines of treatment. In addition, development of maplirpacept, also known as TTI-622, is underway, including in combination with ELREXFIO to support potential mutations in myeloma and acute myeloid leukemia.

    現在來談談血癌。 ELREXFIO (也稱為 elranatamab)需獲得監管部門批准,預計將成為價值數十億美元的特許經營權的支柱。預計美國食品藥物管理局 (FDA) 將在今年就三類復發或難治性多發性骨髓瘤患者的潛在首個適應症做出決定,我們將繼續推進 MagnetisMM 臨床項目,以擴展到更早期的治療領域。此外,maplirpacept(也稱為 TTI-622)的開發正在進行中,包括與 ELREXFIO 聯合使用以支持骨髓瘤和急性髓細胞白血病的潛在突變。

  • Here, we show ELREXFIO data presented at EHA from the MagnetisMM-3 trial in patients with triple-class refractory multiple myeloma who had no prior exposure to BCMA-directed therapy. On the left, we observed highly meaningful survival with ELREXFIO monotherapy with a 15-month overall survival of 57%. In patients who achieved a complete response, 15-month survival was remarkably 93%, underscoring the potential for deep and durable responses.

    這裡我們展示了在 EHA 上公佈的來自 MagnetisMM-3 試驗的 ELREXFIO 數據,該試驗針對的是先前未接受過 BCMA 導向治療的三級難治性多發性骨髓瘤患者。在左側,我們觀察到 ELREXFIO 單一療法具有高度有意義的存活率,15 個月總體存活率為 57%。對於完全緩解的患者,15 個月存活率高達 93%,凸顯了深度和持久緩解的潛力。

  • We can see evidence of broad activity in multiple myeloma on the right, with the graph showing a single agent complete response rate of 35%, which rises to 46% in the subset of patients with 2 to 3 therapy. Our ongoing randomized trials are in less pretreated to newly diagnosed population. Subject to approval, ELREXFIO may have key differentiators such as 50% low hospitalization time during the step-up dosing period per protocol and an extended dosing interval that moves from once weekly to every other week dosing beyond week 24.

    我們可以在右側看到多發性骨髓瘤中廣泛活動的證據,圖表顯示單一藥物的完全緩解率為 35%,而在接受 2 至 3 種療法的患者子集中,該比率上升至 46%。我們正在進行的隨機試驗針對的是接受較少治療至新診斷的族群。經批准後,ELREXFIO 可能具有關鍵的區別因素,例如按照方案增加劑量期間的住院時間短 50%,以及延長給藥間隔,即在第 24 週之後從每週一次變為每隔一周給藥。

  • Turning now to hemophilia A and B, the pivotal trial of marstacimab met its primary endpoint with statistically significant and clinically meaningful effect on annualized bleeding rate or ABR. There was a 35% reduction in ABR compared to prophylactic factor replacement and 92% reduction in ABR versus on-demand factor replacement. Marstacimab offers a differentiated mechanism of action and dosing regimen compared to standard-of-care therapy. If approved, it has the potential to be the first once-weekly subcu hemophilia B treatment for patients without inhibitors and the first hemophilia A or B treatment administered in a patient-friendly pen as a flat dose. Regulatory submission is expected in the second half of '23.

    現在轉向血友病 A 和 B,馬斯塔西單抗的關鍵試驗達到了其主要終點,對年出血率或 ABR 具有統計學上顯著和臨床意義上的影響。與預防性因子替代相比,ABR 降低了 35%,與按需因子替代相比,ABR 降低了 92%。與標準治療相比,Marstacimab 提供了差異化的機制和給藥方案。如果獲得批准,它有可能成為首個針對無抑制劑患者的每週一次皮下注射血友病 B 治療藥物,以及首個以固定劑量、在患者友好型注射筆中給藥的血友病 A 或 B 治療藥物。預計監理提交將於23年下半年進行。

  • Next, LITFULO, also known as ritlecitinib, is the first medicine to receive FDA approval to treat severe alopecia areata in both adults and adolescents 12 years and older. It also recently received a positive opinion from the European Medicines Agency's CHMP recommending body, but it's not yet approved. It has the potential to redefine the standard of care for alopecia areata. LITFULO is the first-of-its-kind kinase inhibitor with a unique mechanism that inhibits both the TEC kinase family and transiently JAK3 pathways that have been implicated in the alopecia areata pathophysiology. In addition, we're exploring how its unique mechanism of action could potentially be applied across immune disorders, including vitiligo, in which a Phase III study is ongoing, and other potential indications.

    接下來,LITFULO(也稱為ritlecitinib)是第一個獲得FDA批准用於治療成人和12歲及以上青少年嚴重斑禿的藥物。該藥物最近也獲得了歐洲藥品管理局 CHMP 推薦機構的積極評價,但尚未獲得批准。它有可能重新定義斑禿的護理標準。 LITFULO 是首創的激酶抑制劑,具有獨特的機制,可抑制與斑禿病理生理學有關的 TEC 激酶家族和暫時性 JAK3 路徑。此外,我們正在探索如何將其獨特的作用機制應用於免疫疾病,包括白斑症(目前正在進行 III 期研究)和其他潛在適應症。

  • Finally, we're making excellent progress on the milestones we have set out through the first half of '24. As Albert noted, we recently received FDA approval for Prevnar 20 in the pediatric population. We have robust strategies in place to potentially improve the protection provided by current pneumococcal vaccines. I look forward to sharing more about this in the coming quarters.

    最後,我們在實現 24 年上半年設定的里程碑方面取得了巨大進展。正如阿爾伯特所說,我們最近獲得了 FDA 批准,可以在兒科人群中使用 Prevnar 20。我們制定了強有力的策略來潛在地提高目前肺炎鏈球菌疫苗所提供的保護。我期待在接下來的幾個季度分享更多有關此內容的資訊。

  • In addition, we recently published Phase 2 data in New England Journal Medicine, showing our Group B streptococcus maternal vaccine candidate was generally well tolerated and generated robust antibody levels. The Journal also published a natural history study, which was used to determine protective antibody levels at birth. These 2 studies indicated that the vaccine candidate may offer meaningful protection to infants born to immunized mothers. We were highly encouraged that Dr. Carol Baker, an infectious disease expert from the University of Texas Health Science Center, wrote an independent NEJM editorial highlighting the important future prospects of our GBS vaccine candidate.

    此外,我們最近在《新英格蘭醫學雜誌》上發表了第二階段的數據,顯示我們的 B 型鏈球菌母體候選疫苗通常耐受性良好並產生強勁的抗體水平。該雜誌還發表了一項自然歷史研究,用於確定出生時的保護性抗體水平。這兩項研究表明,候選疫苗可能為接種疫苗的母親所生的嬰兒提供有意義的保護。我們感到非常鼓舞,德州大學健康科學中心的傳染病專家 Carol Baker 博士撰寫了一篇獨立的 NEJM 社論,強調了我們的 GBS 候選疫苗的重要未來前景。

  • The progress of the GBS vaccine candidate dovetails nicely with the positive result and anticipated upcoming regulatory decision for our RSV vaccine ABRYSVO for administration to pregnant women. ABRYSVO recently received a positive opinion from European Medicines Agency's CHMP for both older adults and maternal immunization to help protect infants. ABRYSVO is approved for older adults all in the U.S. and under regulatory review for the maternal indication.

    GBS 候選疫苗的進展與我們用於孕婦接種的 RSV 疫苗 ABRYSVO 的積極結果和即將出台的監管決定完美契合。 ABRYSVO 最近獲得了歐洲藥品管理局 CHMP 的積極評價,認為其可用於老年人和產婦免疫,以幫助保護嬰兒。 ABRYSVO 已獲准在美國用於老年人,並且正在接受針對產婦適應症的監管審查。

  • In addition, we remain excited to see the Phase 2 data from danuglipron by end of '23, which we expect will enable us to finalize our Phase 3 plan. Finally, I'll call out the Phase 3 trial start of our anti-interferon beta candidate for the treatment of inflammatory muscle myopathies, which has received Fast Track designation from FDA.

    此外,我們仍然很高興看到 23 年底前 danuglipron 的第 2 階段數據,我們預計這將使我們能夠完成第 3 階段計劃。最後,我要宣布我們用於治療發炎性肌肉病變的抗干擾素β候選藥物的 III 期試驗已開始,該藥物已獲得 FDA 的快速通道資格。

  • Thank you. Let me turn it over to Chris to start the Q&A session.

    謝謝。讓我把話題交給克里斯來開始問答環節。

  • Christopher J. Stevo - Senior VP & Chief IR Officer

    Christopher J. Stevo - Senior VP & Chief IR Officer

  • Thank you, Mikael. Chelsea, if you could please queue up the callers. We have at least 30 minutes for our Q&A session now.

    謝謝你,米凱爾。切爾西,請你把打電話的人排隊。我們現在至少有 30 分鐘的時間進行問答環節。

  • Operator

    Operator

  • (Operator Instructions) Our first question will come from Robyn Karnauskas with Truist Securities.

    (操作員指示)我們的第一個問題來自 Truist Securities 的 Robyn Karnauskas。

  • Nicole Germino - Associate

    Nicole Germino - Associate

  • This is Nicole on for Robyn. So just a quick question for us. Can you share what you expect the shared decision making to slow the uptake in the U.S. would be in? What we want to know if they can elaborate -- if you guys can elaborate on why you think this is the case and with peak annual sales is lower than previously expected? And how do you think ex-U.S. sales might be impacted if at all, give the ACIP decision?

    這是 Nicole,代表 Robyn 發言。我只想問我們一個簡單的問題。您能否分享一下您預期的減緩美國接受度的共同決策將會是什麼?我們想知道他們是否可以詳細說明——你們是否可以詳細說明為什麼你們認為會出現這種情況,並且年銷售額的峰值低於先前的預期?您覺得美國以外地區怎麼樣?銷售可能會受到影響,ACIP 會做出什麼決定?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you. Maybe Angela can answer that. The question was, do you expect respiratory disease season to have a big impact on RSV, and also do we expect -- in the U.S. and also do we expect any impact, excluding the U.S.?

    謝謝。也許安琪拉可以回答這個問題。問題是,您是否預期呼吸道疾病季節會對 RSV 產生重大影響?我們是否預計-在美國?此外,我們是否預期除美國以外地區會產生任何影響?

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Sure. So first of all, we're really excited about the approval for our RSV older adult vaccine. And the way I would see the shared clinical decision-making is just that it is a step towards the full routine recommendation that we anticipate. So I think that there is -- the way to look at it is that it's a short-term effect.

    當然。首先,我們對我們的 RSV 老年人疫苗獲得批准感到非常興奮。我認為共享臨床決策只是朝著我們預期的全面常規建議邁出的一步。所以我認為,從某個角度來看,這是一種短期效應。

  • We do expect that with more data that will emerge -- be emerging out of our clinical program, that we'll have an additional opportunity to go back to the ACIP and actually get the routine recommendation that we hope for. So over the next year or so, as we collect and finalize our data, that is really the anticipation of it. So it doesn't change the full opportunity for this particular vaccine. It doesn't change the peak. It just means that it takes us a little bit longer to get to the peak because of the shared clinical decision-making that was -- that extra step that we have to take right now.

    我們確實期望,隨著更多數據的出現——從我們的臨床計畫中湧現出來,我們將有更多的機會回到 ACIP 並真正獲得我們所希望的常規建議。因此,在接下來的一年左右的時間裡,當我們收集並完成我們的數據時,這確實是對它的期望。所以它不會改變這種特定疫苗的全部機會。它不會改變峰值。這只是意味著,由於共同的臨床決策,我們需要更長的時間才能達到頂峰——這是我們現在必須採取的額外步驟。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • And what about the ex-U.S.?

    那麼美國以外地區的情況怎麼樣呢?

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Ex-U.S., actually, we had a different filing. We were able to get both maternal and older adult at the same time, so I think you see slightly different dynamics there in that here in the U.S., our maternal vaccine will be launching later. But in ex-U.S. they'll be -- and in Europe, they will be launching at the same time. And those vaccine technical committees have not opined yet on those recommendations, in particular in terms of the utilization. And so we'll await that. But I think what you have that's different and that's really a great upside is the fact that we have both indications at once.

    實際上,在美國以外,我們有不同的申報。我們能夠同時為產婦和老年人提供疫苗,因此我認為你會看到略有不同的動態,在美國,我們的產婦疫苗將稍後推出。但在美國以外他們將——並且將在歐洲同時推出。而這些疫苗技術委員會尚未對這些建議發表意見,特別是在使用方面。我們將等待這一結果。但我認為你們的情況有所不同,而且這確實是一個很大的優勢,因為我們可以同時擁有這兩種適應症。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much, Angela. I hope we gave you what you asked, Robyn. Operator, the next question please.

    非常感謝,安吉拉。我希望我們能滿足你的要求,羅賓。接線員,請回答下一個問題。

  • Operator

    Operator

  • Next, we have Umer Raffat with Evercore.

    接下來是來自 Evercore 的 Umer Raffat。

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

    Umer Raffat - Senior MD & Senior Analyst of Equity Research

  • I know I heard 2 different things on the cost cut just now. One was that it would be enterprise-wide, while Albert, I think, used the word within the COVID cost base. So I was just trying to reconcile the 2. And also on danuglipron, is it reasonable to expect that if it's below mid-teens weight loss, you wouldn't move forward?

    我知道我剛才聽到了關於削減成本的兩種不同的說法。一是它將是全企業的,而我認為阿爾伯特在 COVID 成本基礎內使用了這個詞。所以我只是試著調和這兩者。而且對於 danuglipron,如果減重低於十幾歲的水平,是否可以合理地預期你不會繼續前進?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Let me clarify. Of course, it will be enterprise-wide, but what I said is that the COVID part is going to be the biggest one. Right now, you need to know that R&D and SI&A cost of COVID is big, it's not a small amount. So it's -- there's a lot of events. Mikael, can you speak a little bit about the prospects to move ahead danu?

    讓我澄清一下。當然,這將是全企業範圍內的影響,但我說的是,COVID 部分將是最大的部分。現在,你需要知道 COVID 的研發和 SI&A 成本很大,這不是一個小數目。所以——有很多事件。米凱爾,您能簡單談談 danu 未來的發展前景嗎?

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • Well, we really look forward to get the data. And as you know, we have in parallel developed activities also for modified leads. I think we really need to look at the totality of data, its performance on important metabolic permit in diabetes, its ability to deliver weight loss as you alluded to, and also, of course, its tolerability in general. These 3 complicate how well the drug can perform.

    嗯,我們真的很期待獲得數據。如您所知,我們也同時進行了針對修改線索的活動。我認為我們確實需要查看全部數據、其在糖尿病重要代謝許可方面的表現、其減肥能力(正如您所提到的),當然還有其整體耐受性。這 3 個因素使該藥物的療效變得複雜。

  • And I remain optimistic that oral drugs in this class can have a profound effect on weight loss. Of course, one needs to be maybe a little bit cautioned to drive weight loss too far, as you have seen also some concerns in public media about side effects that may arise on that. So we will really integrate all of that data and make a decision, and we really look forward to that moment.

    我仍然樂觀地認為,這類口服藥物可以對減肥產生顯著的效果。當然,人們可能需要稍微謹慎,不要減肥過度,正如你在公共媒體上看到的那樣,有些人擔心減肥可能會產生副作用。所以我們會真正整合所有數據並做出決定,我們真的很期待那一刻的到來。

  • Operator

    Operator

  • Our next question will come from Evan Seigerman with BMO.

    我們的下一個問題來自 BMO 的 Evan Seigerman。

  • Evan David Seigerman - MD & Senior BioPharma Research Analyst

    Evan David Seigerman - MD & Senior BioPharma Research Analyst

  • Kind of a follow-up from Umer's, I want to focus on the GLP-1 franchise. Can you talk about the competitive profile of danuglipron in its current form, considering safety, twice-daily dosing and efficacy? And maybe remind us on the timelines to potentially get more on a once-daily formulation of this asset?

    作為 Umer 的後續,我想專注於 GLP-1 系列。考慮到安全性、每日兩次的給藥方式和療效,您能否談談目前 Danuglipron 的競爭力?也許可以在時間表上提醒我們,以便潛在地獲得有關此資產的每日一次配方的更多資訊?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Mikael?

    米凱爾?

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • Yes. As I said in my prepared remarks, we expect data at the later part of this year. We are absolutely encouraged and confident that it has a different profile when it comes to adverse events as the drug lotiglipron that we stopped. So we don't see that as an issue. And I also spoke to that we will put together the totality of data to -- pending readout, prepare a potential Phase 3 program. And it's a very big sector, diabetes and obesity. We have considerable expertise in treating cardiometabolic patients. So we look forward to share more data and more plans with you as we move through the quarter. Thank you for your great interest. It is important to us.

    是的。正如我在準備好的演講中所說,我們預計數據將在今年稍後公佈。我們非常鼓舞,並且相信,就不良事件而言,它與我們停止使用的藥物洛替利隆 (lotiglipron) 有不同的表現。所以我們不認為這是一個問題。我還說過,我們將匯總所有待讀取的數據,為潛在的第三階段計劃做準備。糖尿病和肥胖症是一個非常大的領域。我們在治療心臟代謝患者方面擁有豐富的專業知識。因此,我們期待在本季與您分享更多數據和計劃。感謝您的關注。這對我們很重要。

  • Operator

    Operator

  • Next, we have Terence Flynn with Morgan Stanley.

    接下來是摩根士丹利的特倫斯弗林 (Terence Flynn)。

  • Terence C. Flynn - Equity Analyst

    Terence C. Flynn - Equity Analyst

  • Maybe 2 for me. Dave, I was just wondering how we should think about steady-state operating margin here. Looking back pre-COVID, the company was around mid- to high 30% range. So is that how we should think about this when you gave us some of the parameters, but just maybe how to think about steady state?

    對我來說也許應該是 2。戴夫,我只是想知道我們應該如何考慮這裡的穩態營業利潤率。在回顧疫情之前,該公司的獲利水準約為 30% 至 30% 的中高水準。那麼,當您給我們一些參數時,我們應該如何思考這個問題,但也許應該如何思考穩定狀態?

  • And then on the messenger RNA Phase 3 seasonal flu vaccine program, it looks like that trial was upsized based on clinicaltrials.gov. So just wondering, Mikael, if you can talk through timing of data and help frame expectations there.

    然後關於信使 RNA 第三階段季節性流感疫苗計劃,根據 clinicaltrials.gov 的數據,該試驗的規模似乎有所擴大。所以只是想知道,Mikael,您是否可以討論一下資料的時間問題並幫助建立預期。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Terence. Let's start with Dave.

    謝謝你,特倫斯。讓我們從戴夫開始。

  • David M. Denton - CFO & Executive VP

    David M. Denton - CFO & Executive VP

  • Yes, so great question. As we think about our operating margin long term, clearly, our objective is to expand that over time. Clearly, it is our expectation to get back to, at a minimum, pre-COVID levels with one caveat is that we -- as we go forward, we do have a different mix of products within our portfolio, particularly the vaccine related to COVID.

    是的,這個問題問得真好。當我們考慮長期營業利潤率時,顯然我們的目標是隨著時間的推移擴大這一利潤率。顯然,我們期望至少恢復到新冠疫情之前的水平,但有一個需要注意的一點是,隨著時間的推移,我們的產品組合中確實會有不同的產品組合,尤其是與新冠疫情相關的疫苗。

  • As you know, the vaccine, given the cost share that we have or profit share that we have with our partner, does dilute that product from an operating margin perspective. So with mix adjusted, you should see us back to those levels over time. But obviously, as we cycle into '24, we'll give you a lot more clarity on all the puts and takes as we integrate Seagen, as we roll forward from a COVID franchise perspective, how that looks, as well as all the developments that we have coming out the pipeline at this point in time.

    如您所知,考慮到我們與合作夥伴的成本份額或利潤份額,從營業利潤率的角度來看,疫苗確實會稀釋該產品。因此,隨著組合調整,您應該會看到我們隨著時間的推移回到這些水平。但顯然,隨著我們進入 24 年,我們將為您提供更清晰的關於整合 Seagen 的所有投入和產出,以及從 COVID 特許經營的角度向前推進的情況,以及我們目前正在進行的所有開發工作。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, David. Mikael, mRNA, flu.

    謝謝你,大衛。米凱爾,mRNA,流感。

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • Yes. First, the totality of experience we have with mRNA for flu makes me very encouraged that this will be the new modality as it was for COVID but now for flu, that engages [through mechanism] the B cells and the T cell that we should aspire for, having better efficacy than what we have seen with the old flu. We are continuing with the study because we just wanted to have more events and particularly have addition of a flu V type of events, which were scarce in the newest part of the trial.

    是的。首先,我們在流感 mRNA 治療方面的全部經驗讓我感到非常鼓舞,這將成為一種新的治療方式,就像治療 COVID 一樣,但現在是治療流感的新方式,它透過機制與 B 細胞和 T 細胞互動,這是我們應該追求的,其療效比我們在舊流感中看到的更好。我們將繼續進行這項研究,因為我們只是想有更多的事件,特別是增加流感 V 型事件,這在試驗的最新部分中很少見。

  • And we look forward to update you, hopefully, be able to conclude the study later this year. But we also are putting mitigations as adding immunity studies that can be supplementary for getting a total good data package of activity against flu A and flu B. But as I said, I remain very optimistic that the mRNA is going to be the next important platform to deal with flu. Thank you.

    我們期待向您通報最新情況,希望能夠在今年稍後完成這項研究。但是,我們也將緩解措施作為補充免疫研究,這可以作為補充,以獲得針對甲型流感和乙型流感活動的完整良好資料包。但正如我所說,我仍然非常樂觀地認為,mRNA 將成為下一個應對流感的重要平台。謝謝。

  • Operator

    Operator

  • Next, we have Chris Shibutani with Goldman Sachs.

    接下來是高盛的 Chris Shibutani。

  • Chris Shibutani - Research Analyst

    Chris Shibutani - Research Analyst

  • Two questions, if I may. On the potential enterprise-wide cost program, you would have some opportunity outside of the COVID programs to consider? Can you help us with the relative weighting potentially of R&D versus SG&A or some other component of that? And I ask that in part because you've announced some changes, for instance, in kind of the structure at the top tier of management of the R&D with the anticipation of the oncology and Seattle Genetics.

    請問我有兩個問題。在潛在的企業範圍成本計劃中,您是否會考慮 COVID 計劃之外的一些機會?您能否幫助我們確定研發費用、銷售、一般及行政費用或其他組成部分的相對權重?我之所以問這個問題,部分是因為你們宣布了一些變化,例如,為了回應腫瘤學和西雅圖遺傳學研究,研發最高層管理結構的變化。

  • And then secondly, if I could, on the Rocky Mount facility, it's reassuring to hear in terms of your own staff. But I think folks are looking to get a sense for the scale of the damage and perhaps what potential gating factors for getting more information on timing? I know that you guys have communicated with some of your hospital-based customers, but any additional insights in terms of magnitude, impact and timing of the recovery, and what that could look like from a progress standpoint would be helpful.

    其次,如果可以的話,關於洛基山工廠,聽到你們自己員工的消息讓我感到很放心。但我認為人們希望了解損害的規模,並希望了解獲取更多有關時間資訊的潛在限制因素是什麼?我知道你們已經與一些醫院客戶進行了溝通,但對於恢復的規模、影響和時間,以及從進展的角度來看,任何額外的見解都會有所幫助。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Let me say a few words about the Rocky Mount, and then I'll ask Dave to answer the question about the cost adjustment program in case we have a significant reduction on our revenues because of the COVID. The Rocky Mount, it was severe the damage of the hurricane, but the damage was mainly concentrated on the warehouse, which means that we lost a lot of inventory that was about to be sent to the market. The facilities per se, the production facilities were not impacted by the hurricanes, so the buildings are standing there. However, because the utilities were discontinued, the facilities had to stop operating. And in this highly sensitive sterile environment, when you are losing power, it's not easy to switch on and switch off. It takes time and a lot of processes so that we can start it.

    讓我先講一下 Rocky Mount,然後我會請戴夫回答有關成本調整計劃的問題,以防我們的收入因 COVID 而大幅減少。洛基山的颶風造成的破壞很嚴重,但破壞主要集中在倉庫,這意味著我們損失了大量即將送往市場的庫存。設施本身、生產設施並未受到颶風的影響,因此建築物仍矗立在那裡。然而,由於公用設施中斷,這些設施不得不停止運作。在這種高度敏感的無菌環境中,當斷電時,很難打開和關閉電源。我們需要時間和很多流程才能開始。

  • And the additional challenge will be some of the inventories of materials that were also destroyed, particularly glass and other startup, we need to make sure that we will replace in time. So what I want to say is that we feel very confident that the whole thing will go back to life. But still, we are assessing how long that will take. And we are doing anything we can to make sure that we will minimize the shortages in the marketplace because of that. Now let's move to some more color on the cost adjustment program.

    額外的挑戰是一些材料庫存也被摧毀了,特別是玻璃和其他啟動材料,我們需要確保及時替換。所以我想說的是,我們非常有信心整件事情將恢復正常。但我們仍在評估這需要多長時間。我們正在竭盡全力,確保將由此造成的市場短缺問題降到最低。現在讓我們進一步了解成本調整計劃。

  • David M. Denton - CFO & Executive VP

    David M. Denton - CFO & Executive VP

  • Yes. So thank you for the question. Clearly, as we develop this program in the back half of '23, we look forward to sharing a lot more details as we cycle into '24 and give you a lot of, I'll say, milestones as you think about both our cost and investment structure going forward. Importantly, as you know, we're extremely excited about the Seagen acquisition that's upcoming here.

    是的。感謝您的提問。顯然,當我們在23年下半年開發這個項目時,我們期待在進入24年時分享更多細節,並在您考慮我們未來的成本和投資結構時為您提供很多里程碑。重要的是,如您所知,我們對即將進行的 Seagen 收購感到非常興奮。

  • Upon approval, this will allow the company to refocus its efforts and its investments to make sure that we're squarely focused on battling cancer going forward. And we think there's a big opportunity as we align our resources against that franchise and that battle to fight cancer, and an opportunity for patients and importantly, an opportunity long term for Pfizer.

    一旦獲得批准,公司將能夠重新調整其努力和投資,以確保我們在未來能夠全心全意地對抗癌症。我們認為,當我們將資源投入到這項特許經營和對抗癌症的鬥爭中時,這將是一個巨大的機遇,這對患者來說也是一個機遇,更重要的是,對輝瑞來說也是一個長期機會。

  • Having said that, we will be informed in the back half of the year of our revenue performance, specifically as it relates to COVID. That will inform us the level of opportunity we have to expand our margins into '24 and '25 and beyond. That will allow us to step back and make sure that all of our costs, all our investments are aligned with those Seagen objectives as well as aligned to maximizing the performance of our in-line portfolio as well as the launches that are occurring as we speak in the back half of this year.

    話雖如此,我們將在下半年獲悉我們的收入表現,特別是與 COVID 相關的情況。這將使我們了解在2024年、2025年及以後擴大利潤率的機會水準。這將使我們能夠退一步,確保我們的所有成本、所有投資都與 Seagen 目標保持一致,同時也與最大限度地提高我們在線投資組合的業績以及今年下半年正在進行的發布保持一致。

  • So again, we look forward to sharing a lot more to this -- from this. This will be balanced, as you well know between SI&A and R&D, and we'll give you that specific breakdown and that specific information later this year and into next year.

    因此,我們再次期待分享更多這方面的資訊。如您所知,這將是在 SI&A 和 R&D 之間保持平衡的,我們將在今年晚些時候和明年為您提供具體的細目和具體資訊。

  • Operator

    Operator

  • Next, we have Louise Chen with Cantor.

    接下來我們有請 Cantor 的 Louise Chen。

  • Louise Alesandra Chen - MD & Senior Research Analyst

    Louise Alesandra Chen - MD & Senior Research Analyst

  • Wanted to ask you first on these COVID scenarios that you think could unfold in the second half '23. Any way you could share some of the big ones that you anticipate could potentially happen? And then secondly, seeing a lot of headlines in the ATTR-CM space. I'm just curious if you anticipate any potential competition or meaningful competition to VYNDAQEL, VYNDAMAX?

    首先我想問一下您認為 2023 年下半年可能出現的 COVID 情景。您能否分享一些您預計可能發生的重大事件?其次,在 ATTR-CM 領域看到很多頭條新聞。我只是好奇,您是否預計 VYNDAQEL、VYNDAMAX 會面臨任何潛在競爭或有意義的競爭?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • All right. So on the COVID, I will say a few words and then I will ask Angela to comment on both. Look, the COVID scenarios, it depends. What are the uncertainties? I think I articulated. Let's start with the vaccine. The biggest uncertainty is vaccination rates. I think market share is pretty much, I think, well established. Vaccination rate is what we are going to see in the fall that is coming. So that will be a big concern.

    好的。因此,關於 COVID,我會講幾句話,然後我會請安吉拉對兩者發表評論。這要視 COVID 的情況而定。有哪些不確定性?我想我已經表達清楚了。讓我們從疫苗開始。最大的不確定性是疫苗接種率。我認為市場佔有率已經相當穩定。疫苗接種率是我們在即將到來的秋天將要看到的。所以這將是一個大問題。

  • Another uncertainty was the time of commercialization in the U.S. because, of course, you go with new inventories, new sales to the market and with higher prices. That has been resolved. We know that it's very likely that we will launch in September because FDA and CDC they asked us to change the inventories basically by creating a new vaccine. So that will happen.

    另一個不確定因素是美國的商業化時間,因為當然會有新的庫存、新的市場銷售以及更高的價格。問題已經解決。我們知道很有可能會在 9 月推出,因為 FDA 和 CDC 要求我們透過研發新疫苗來改變庫存。所以那會發生。

  • And also, the other uncertainty that existed about the COVID vaccine was the European contract. That was a very long -- very big contract. And now we have ascertained that it has been negotiated, a little bit less for the year because it's spread over 4 years, but it's renegotiated. So all of that are the key uncertainty. Of course, there is how much LatAm, Latin America, and other countries, would prefer this. It's not the only ones, but we think those are the fundamentals.

    此外,有關 COVID 疫苗存在的另一個不確定因素是歐洲合約。這是一份非常長且巨大的合約。現在我們已經確定已經進行了談判,雖然今年的金額少了一點,因為談判分四年進行,但是已經重新進行了談判。所以所有這些都是關鍵的不確定因素。當然,拉丁美洲和其他國家也非常希望看到這種現象。雖然這不是唯一的因素,但我們認為這些是基本因素。

  • And we will know pretty much the trend in the third quarter. And we will know pretty much, quite accurate, what is the situation in the end of the year, that I think will be a very big predictor of what you should expect going forward with the only upside if we have a combined vaccine with flu or with RSV that, that will increase the vaccination rate.

    我們將在第三季了解大致的趨勢。我們將非常準確地了解年底的情況,我認為這將是一個非常重要的預測指標,可以預測未來的發展情況,唯一的好處是如果我們有了流感或呼吸道合胞病毒的聯合疫苗,這將提高疫苗接種率。

  • On PAXLOVID, a little bit more uncertainty because, of course, we are having the uncertainty of treatment rates and infection rates. And we don't know how that will behave. We don't have any benchmarks to see how that goes. We know that the treatment rates are following very closely the infection rates, and the infection rates are rising right now. But remains to be seen how that will work. Of course, also the same with PAXLOVID arising and receive the market, the scripts on a weekly basis as always do when the infection rates are going up.

    對於 PAXLOVID 而言,不確定性稍微大一些,因為我們對治療率和感染率有不確定性。我們不知道它將會如何表現。我們沒有任何基準來了解其進度。我們知道治療率與感染率密切相關,而感染率目前正在上升。但其效果如何仍有待觀察。當然,就像PAXLOVID的出現和進入市場一樣,當感染率上升時,每週的腳本總是會這樣做。

  • But we have some more uncertainties over there, which is the timing of launch, which will depend on how we will agree for the interest of public health to transition this launch with the various governments. So all of that remains to be seen. And these are the scenarios that we see for COVID. And the key message it is the uncertainty will go away at the end of the year. We will know what COVID will contribute on a stable basis in Pfizer's revenue and we will go from there.

    但我們在那裡仍存在一些不確定性,那就是發射的時間,這將取決於我們如何與各國政府就公共衛生利益的轉變達成協議。因此,所有這一切還有待觀察。這些就是我們在 COVID 中看到的情況。關鍵訊息是,不確定性將在年底消失。我們將了解 COVID 將為輝瑞的收入做出多少穩定貢獻,然後我們將從那裡開始。

  • Now Angela, maybe if you want anything to add to that and talk about the next question -- the other question.

    現在安吉拉,如果你想補充什麼,可以討論下一個問題——另一個問題。

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Louise, I think when you talk about VYNDAMAX or VYNDAQEL, the biggest and our biggest differentiator that we're extremely confident about is just the totality of our data, really, along 4 dimensions. And whether that's clinical data or real-world data. We have all-cause mortality and CV-related hospitalization data. Our data also relevant in both hereditary and wild-type ATTR-CM, so that's unique.

    路易絲,我認為當您談到 VYNDAMAX 或 VYNDAQEL 時,我們非常有信心的最大、也是最顯著的區別因素就是我們的數據總體,實際上是沿著 4 個維度的。無論是臨床數據還是真實世界數據。我們有全因死亡率和心血管相關住院數據。我們的數據也與遺傳型和野生型 ATTR-CM 相關,因此這是獨一無二的。

  • We've also demonstrated significant survival benefit at 5 years through our real-world data. So whichever way you look at it, and if you compare that with any competitor program, I think that we have a highly differentiated and an extremely valuable molecule that stacks up well against any competition.

    我們也透過真實世界數據證明了 5 年存活率的顯著提高。因此,無論你從哪個角度看,如果將其與任何競爭對手的項目進行比較,我認為我們擁有高度差異化和極具價值的分子,可以在任何競爭中脫穎而出。

  • Operator

    Operator

  • Next, we have Mohit Bansal with Wells Fargo.

    接下來是富國銀行的 Mohit Bansal。

  • Mohit Bansal - Senior Equity Analyst

    Mohit Bansal - Senior Equity Analyst

  • And maybe a follow-up to this one a little bit. So thank you for all the transparency, by the way. So is it fair to say that in COVID trends that you have seen so far, at least sales trend that had been below your expectations, and you want to see 1 more quarter before you adjust expectations. I'm asking this because if I look at the -- it seems like you still expect 88 million or so vaccinations in the second half of the year in the U.S. and the number was actually, by our conversion, 44 million or so in terms of administration, 111 million in terms of shipments. So just trying to understand, is it like -- is it something where you are -- where we could get better update in third quarter on the COVID numbers?

    或許可以稍微跟進一下這一點。順便說一句,感謝你們的透明度。因此,是否可以公平地說,在您迄今為止看到的 COVID 趨勢中,至少銷售趨勢低於您的預期,並且您希望再觀察 1 個季度然後再調整預期。我之所以問這個問題,是因為如果我看一下——似乎你仍然預計今年下半年美國將有 8800 萬劑左右的疫苗接種,而根據我們的換算,實際上接種疫苗的數量約為 4400 萬劑,發貨量約為 1.11 億劑。所以只是想了解一下,這是否像——在您所在的地方——我們可以在第三季度更好地更新 COVID 數字嗎?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. Thank you for the question. I think the answer is yes, we should get way better still. It's not that we just want to see another quarter. We want to see the big quarter of the respiratory season. COVID, we always said and everybody, I think, thinks that, that is a common sense. But we'll follow going forward the seasonality of the other respiratory vaccines. That's becoming more and more and more clear, right?

    是的。感謝您的提問。我認為答案是肯定的,我們應該做得更好。這並不是說我們只是想看到另一個季度。我們希望看到呼吸道疾病的旺季。我們總是說 COVID,我認為每個人都認為這是常識。但我們將繼續關注其他呼吸道疫苗的季節性。這變得越來越清晰了,對吧?

  • And the majority of these vaccinations are happening in the third and fourth quarter for the year. So it's not that we are just another quarter. We're awaiting the main quarter. If COVID vaccinations go anywhere close to the flu vaccination rates, then we have a very big bit of what we expect to have. If they are a small fraction of what will happen for flu, then of course, we have a miss. So that's why we are going to see how that will evolve. So it's a very, very important quarter.

    大多數疫苗接種都發生在今年第三季和第四季。所以,我們不只是另一個季度。我們正在等待主要季度。如果 COVID 疫苗接種率接近流感疫苗接種率,那麼我們就有很大一部分達到了我們的預期。如果它們只是流感的一小部分,那麼我們當然會錯過。這就是為什麼我們要觀察事情將如何發展。所以這是一個非常非常重要的季度。

  • The rest, although for the first half of the year, we have got significant contribution towards the total growth. So we don't need that much of inventory if we have the utilization over there to make sure that we know how big the COVID franchise will become. And as I said, in the EU, we have adjusted very well. We know we'll have high certainty. PAXLOVID because China is a very, very good market. We don't know how in the next wave the PAXLOVID will be used.

    其餘部分,儘管在上半年,我們對整體成長做出了重大貢獻。因此,如果我們在那裡利用率很高的話,我們就不需要那麼多庫存,以確保我們知道 COVID 特許經營權將變得有多大。正如我所說,在歐盟,我們已經調整得很好了。我們知道我們會有很高的確定性。 PAXLOVID,因為中國是一個非常非常好的市場。我們不知道下一波 PAXLOVID 將如何使用。

  • We have the rest of the world, but the inventories, they were also last year. So we are now expecting that the products will start being going out or (inaudible) product will start more reordering from many more countries. So that's why the infection rates on the PAXLOVID will be extremely, extremely important. And all of that are happening now. So once we know them, we can predict way more accurately. Thank you very much.

    我們有世界其他地區的庫存,但庫存量與去年相同。因此,我們現在預計產品將開始外銷,或(聽不清楚)產品將開始從更多國家重新訂購。這就是為什麼 PAXLOVID 的感染率極為重要。而這一切現在都正在發生。所以一旦我們了解了它們,我們就可以更準確地預測。非常感謝。

  • Operator

    Operator

  • Next, we have Trung Huynh with Credit Suisse.

    接下來是瑞士信貸的 Trung Huynh。

  • Trung Chuong Huynh - Research Analyst

    Trung Chuong Huynh - Research Analyst

  • You commented the long-term outlook for your non-COVID business remains intact relative to the 2030 ambitions. How are you thinking about the midterm 2025 guide because if you assume the midpoint of your ex-COVID '23 guide at 7%, in order to achieve the 6% 2020 to 2025 guidance ex-COVID, on our calculations, you need to do high single-digit growth for that base business for '24 and '25. That looks tough especially as you'll have more LOEs. So do you remain confident in that midterm guide?

    您評論說,相對於 2030 年的目標,您的非 COVID 業務的長期前景仍然完好無損。您如何看待 2025 年中期指南,因為如果您假設除新冠疫情外 2023 年指南的中點為 7%,那麼為了實現除新冠疫情外 2020 年至 2025 年 6% 的指南,根據我們的計算,您需要在 2024 年和 2025 年使該基礎業務實現高個位數增長。這看起來很難,特別是當你有更多的 LOE 時。那麼您對該中期指南仍然有信心嗎?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes, thank you. The LOEs are coming basically from year '26, right? So all the way to '25, I think the impact will not be that high. Also, the guidance that we gave was 6%, if I'm -- yes, we feel quite confident that we will be there. So we'll continue and we are at 6% right now all these years, right, year-to-date. So yes, the non-COVID business, I think clearly, the success of the launches is very important. So we'll see a lot of things coming ahead of us. But it is way better predictable. And I think we are there, so I don't think there will be any variability. Thank you for the question, by the way.

    是的,謝謝。 LOE 基本上是從 26 年開始的,對嗎?所以一直到25年,我認為影響不會那麼大。此外,我們給的指導價格是 6%,如果我沒記錯的話,我們非常有信心能夠達到這個目標。因此我們會繼續下去,這些年來,今年到目前為止,我們的成長率一直保持在 6%。所以是的,對於非 COVID 業務,我顯然認為,發布的成功非常重要。因此,我們將會看到很多事情發生在我們面前。但它的可預測性更強。我認為我們已經達到了這個水平,因此我認為不會有任何變化。順便說一句,感謝您的提問。

  • Operator

    Operator

  • Next, we have Colin Bristow with UBS.

    接下來是瑞銀的柯林布里斯托。

  • Colin Nigel Bristow - Analyst

    Colin Nigel Bristow - Analyst

  • Another follow-up on danuglipron. I just didn't have the answer in terms of when we'll hear about the once-daily formulation. And I'd just like to understand your level of confidence here that you can make this a once-daily formulation without negatively impacting the AE profile, presumably given an increase in Cmax.

    對 danuglipron 的另一項後續研究。我只是不知道我們什麼時候才能聽到有關每日一次的配方的消息。我只是想了解一下您的信心水平,您可以將其製成每日一次的配方,而不會對 AE 特徵產生負面影響,大概是因為 Cmax 增加了。

  • And then more broadly, can you just talk more about how you're going to compete here, given I think it was previously referenced you're behind the competition, the clinical differentiation, the potentially less convenient dosing and essentially a therapeutic category in which you don't have a major presence. And then just maybe one other quick one on a pipeline item, on DMD gene therapy. It's a late-stage asset that doesn't seem to get much airtime. Is your enthusiasm waning on this program? Or is it just that others are sort of a bigger priority?

    然後從更廣泛的角度來說,您能否更多地談談您將如何在這裡競爭,因為我認為之前提到過,您在競爭中落後了,臨床差異化、可能不太方便的劑量以及本質上您在治療類別中沒有主要存在。然後可能還有另一個關於 DMD 基因治療的管道項目的簡短介紹。它是一種後期資產,似乎沒有獲得太多的關注。您對這個專案的熱情是否正在減弱?或只是其他事項有更大的優先權?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes, thank you. So Mikael, again, clearly the obesity market and the size of it is creating a lot of interest in danuglipron and -- so the question was about the 1-day formulation. And then also tell us a little bit about where we are with DMD.

    是的,謝謝。所以 Mikael 再次強調,顯然肥胖市場及其規模引起了人們對 Danuglipron 的極大興趣,所以問題是關於 1 天配方的。然後請向我們介紹一下 DMD 的情況。

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • I hear your interest in a once-daily product, and I would say I don't see any particular barrier for us in creating that. We have tremendous experience in modified release formulation. And our early data, as we now have initiated a while ago, tells us we should be encouraged that when it relates to once-a-day modified release for danuglipron, I believe we will have such a formulation in a reasonable future in our hands.

    我聽說您對每日一次的產品很感興趣,我想說,我認為我們在創造這種產品時不會遇到任何特別的障礙。我們在改良釋放配方方面有豐富的經驗。而且,正如我們不久前開始研究的那樣,我們的早期數據告訴我們,當涉及到達格列隆的每日一次緩釋劑型時,我們應該感到鼓舞,我相信在合理的未來我們將擁有這樣的配方。

  • When could it come to the market if the drug continues and makes a great Phase 3? Well, I think we can have it at launch or shortly after launch. So I wouldn't worry about that. But I agree with you that once-daily modified release can sometimes actually improve the tolerability profile by (inaudible) and the variability and exposure, which typically reduce GI side effects that have been seen as limiting this drug. So that's why I can see a potential twofold advantage of an MR goes from twice a day to once a day, and may also help uniquely to create a tolerability profile within the structures of oral GLPs.

    如果該藥物繼續進行並取得第 3 階段的良好進展,什麼時候會上市?嗯,我認為我們可以在發佈時或發布後不久獲得它。所以我不會擔心這個。但我同意您的看法,每日一次的緩釋片有時實際上可以透過(聽不清楚)以及變異性和暴露性來改善耐受性,這通常可以減少被視為限制這種藥物的胃腸道副作用。所以這就是為什麼我看到 MR 從每天兩次變為每天一次的潛在雙重優勢,並且還可能以獨特的方式幫助在口服 GLP 結構中創建耐受性概況。

  • DMD gene therapy I'm encouraged that the FDA took a very positive angle on that drug when it comes to its urgency to get into the market. Chris, you and I have worked very closely on that, and we expect today relatively soon to conclude the trial. I'll also ask Chris to pitch in on it.

    DMD 基因治療我很高興 FDA 在談到該藥物進入市場的緊迫性時採取了非常積極的態度。克里斯,你和我在這方面進行了密切合作,我們預計今天將相對較快地結束審判。我還會請克里斯參與此事。

  • Chris Boshoff - Executive VP and Chief Oncology Research & Development Officer

    Chris Boshoff - Executive VP and Chief Oncology Research & Development Officer

  • Thank you, Mikael. So the DMD program is obviously very important for us not just for the importance of gene therapy but for patients and families with this absolutely devastating disease. And we do have an interim analysis later this year for the CIFFREO trial. The CIFFREO trial, all patients have now been enrolled in the study. The interim analysis will be based not on a surrogate biomarker end point but on truly functional end point. So we believe that's the best way to measure the benefit of gene therapy in this disease is with a functional end point. And that should come later this year, and we'll update you with the final analysis for the study then in 2024.

    謝謝你,米凱爾。因此,DMD 計畫對我們來說顯然非常重要,這不僅是因為基因療法的重要性,而且對於患有這種極其嚴重疾病的患者和家屬也非常重要。今年稍後我們將對 CIFFREO 試驗進行中期分析。 CIFFREO 試驗,所有患者目前都已參與研究。中期分析將不是基於替代生物標記終點,而是基於真正的功能終點。因此,我們認為衡量這種疾病的基因治療益處的最佳方法是通過功能終點。這應該會在今年稍後實現,我們將在 2024 年向您提供該研究的最終分析結果。

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • That was terrific. I just wanted to add that we have, like you heard Sarepta [enroll] biomarker data that look very robust in our hand. But as Chris said, we want to provide patients with even more experience about the potential benefit.

    那太棒了。我只是想補充一點,就像你所聽到的,我們擁有的 Sarepta [登記] 生物標記數據看起來非常可靠。但正如克里斯所說,我們希望為患者提供更多關於潛在益處的體驗。

  • Operator

    Operator

  • Next, we have Kerry Holford with Berenberg.

    接下來是 Berenberg 公司的 Kerry Holford。

  • Kerry Ann Holford - Analyst

    Kerry Ann Holford - Analyst

  • A couple of questions (inaudible). It's clear that demand for your COVID assets will influence whether or not you go down this rig. But given the potential you've highlighted previously for a COVID-flu combination vaccine, I'm interested to understand whether the upcoming Phase 3 data from your mRNA flu vaccine trial will influence your decisions on that cost saving program in any way.

    有幾個問題(聽不清楚)。很明顯,對 COVID 資產的需求將影響您是否繼續從事這項工作。但考慮到您之前強調的 COVID-流感聯合疫苗的潛力,我有興趣了解您即將進行的 mRNA 流感疫苗試驗的第三階段數據是否會以任何方式影響您對該成本節約計劃的決定。

  • And then secondly, on hemophilia, your anti-TFPI say you're filing second half of this year for noninhibitor patients. Should we assume you would seek to launch in that patient group only next year? Or would you wait for the detail in the inhibitor patient group before you proceed to market? And perhaps you can just discuss how big an opportunity you see in that drug.

    其次,關於血友病,您的抗 TFPI 表示您將在今年下半年為非抑制劑患者提交申請。我們是否應該假設您會在明年才尋求在該患者群體中開展業務?或者你會等待抑制劑患者群體中的詳細資訊後再進入市場嗎?或許您可以討論一下您認為這種藥物的機會有多大。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Let me start with the COVID and then Mikael also can comment. But for example, we are very excited about the combinations, right? And the combinations will be flu and COVID and then also flu, COVID and RSV. And we are working on that. And we believe actually that the fact that if we have a combination with the non-mRNA included although that we have likely that we expect to have the benefit of better safety profile because we don't have to load 3 product's RNA into a single injection, but we will be using only 2, COVID and flu, and then we'll use the protein-based vaccine (inaudible). All of that are working very well.

    讓我先從 COVID 開始,然後 Mikael 也可以發表評論。但是例如,我們對這些組合感到非常興奮,對嗎?這些組合包括流感和新冠肺炎,以及流感、新冠肺炎和呼吸道合胞病毒。我們正在努力實現這一目標。我們實際上相信,如果我們將非 mRNA 包含在內,儘管我們有可能期望獲得更好的安全性,因為我們不必將 3 種產品的 RNA 裝入一次注射中,但我們將只使用 2 種,即 COVID 和流感,然後我們將使用基於蛋白質的疫苗(聽不清楚)。所有一切進展順利。

  • Now the question is what will happen if the COVID market is seen to be very -- is monovalent. It's very, very low. I think that will play here in our decision about controlling the cost because if it is very, very low, although we expect an upside in the combination, we will assume at this stage that the medical need for COVID is not that high. And as a result, we will reduce our investments in the area and also temper our expectations for sales. And then if the combinations come and we are way more successful, then we restore. You want also -- what was your second question? Yes, about the marstacimab. Mikael?

    現在的問題是,如果 COVID 市場被視為非常單價,會發生什麼。它非常非常低。我認為這會影響我們控製成本的決策,因為如果成本非常非常低,儘管我們預計組合成本會上升,但我們現階段會假設 COVID 的醫療需求並沒有那麼高。因此,我們將減少在該地區的投資,並降低對銷售的預期。然後,如果組合成功,我們就會恢復。您還想-您的第二個問題是什麼?是的,關於 marstacimab。米凱爾?

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • I'm very excited about marstacimab. I follow this project for a long time. And as you know, we reported out a very encouraging data. We had 92% reduction in annual bleeding rate versus on-demand. We had really no safety events that has been associated with other products, including Hemlibra. It's active against both A and B. It's administrated with a prefilled pen. I think it can be, from a medical point of view, a very large product, a single option for hemophilia A and B. Of course, when I think about how Hemlibra has been such a promise for heme A patient and I see this profile that looks so good, I'm optimistic that it can do well in both segments.

    我對 marstacimab 感到非常興奮。我關注這個項目很久了。正如你們所知,我們報告了非常令人鼓舞的數據。與按需相比,我們的年出血率降低了 92%。我們確實沒有遇到與其他產品(包括 Hemlibra)相關的安全事件。它對 A 和 B 均有效。它是用預充注射筆注射的。我認為從醫學角度來看,它可以是一個非常大的產品,是治療 A 型血友病和 B 型血友病的唯一選擇。當然,當我想到 Hemlibra 對 A 型血友病患者的希望如此之大,而且我看到這個產品看起來如此好時,我對它可以在兩個領域都表現出色感到樂觀。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much. Let's move to the next question, please. And we are a little bit -- the time is flying. So a lot of interest. So let's try to be more -- one question, please.

    非常感謝。請讓我們進入下一個問題。我們有點——時間過得真快。所以很有興趣。因此,請讓我們嘗試多問一個問題。

  • Operator

    Operator

  • Our next question will come from Geoff Meacham with Bank of America.

    我們的下一個問題來自美國銀行的傑夫·米查姆。

  • Geoffrey Christopher Meacham - Research Analyst

    Geoffrey Christopher Meacham - Research Analyst

  • Just had 2 real quick ones. Angela, on Prevnar, what does long-term growth look like? Clearly, you may have a tougher competitive environment. Just if you lose share, what do you think the [TAM growth] could look like to offset that? And then Mikael, you talked a little bit about next-gen CDK. I know it's super early in development. But is there a risk-benefit hurdle you have in line? I'm just thinking about cost benefit post-IBRANCE LOE and also considering the competitive landscape.

    剛剛吃了 2 個非常快的。安吉拉,在 Prevnar 上,長期成長是什麼樣的?顯然,您可能會面臨更嚴峻的競爭環境。如果您失去市場份額,您認為 [TAM 成長] 會是什麼樣子來抵銷這一損失?然後 Mikael,您談到了下一代 CDK。我知道它還處於開發初期。但您是否面臨風險效益障礙?我只是在考慮 IBRANCE LOE 後的成本效益,同時也考慮競爭格局。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • So Angela, how concerned you are with the competitive environment, with respect to our competitors, but we have some realities that maybe you want to discuss. And also, I will ask -- actually, it will be Chris Boshoff to answer the question of CDK4 since we have him here in his new capacity. Angela?

    那麼安琪拉,對於我們的競爭對手,你對競爭環境有多擔心,但我們有一些現實情況也許你想討論一下。另外,我想問一下——實際上,由於 Chris Boshoff 以新身份來到這裡,因此他將回答有關 CDK4 的問題。安吉拉?

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Well, I mean, I want to begin by just saying how I'm incredibly proud we are of the performance of the entire Prevnar franchise. If you look at the adult indication, we have grown -- not only have we grown 23% since last year this time, we are doing all of this growth prior to the full vaccination season, which is what you typically see. So the fact that we've been able to bring these vaccinations tell us a lot about the work that we've done in pneumococcal disease, how well appreciated it is, but also how well our machinery is working, not to mention the fact that we have 96% share of the adult indication.

    嗯,我的意思是,首先我想說,我對整個 Prevnar 系列的表現感到無比自豪。如果你看一下成人適應症,我們已經成長了——不僅自去年同期以來增長了 23%,而且我們在整個疫苗接種季節之前都實現了所有這些增長,這是你通常會看到的。因此,我們能夠帶來這些疫苗這一事實充分說明了我們在肺炎球菌疾病方面所做的工作,它得到了多麼廣泛的認可,也說明了我們的機器運作良好,更不用說我們佔據了成人適應症的 96% 份額。

  • In peds also, of course, being that we went from being 100% of the market, today, we share some of that market share with PCV15. But I just want to remind everyone that, that is to be expected, and we are exactly where we thought we would be. And so from that perspective, we're also really proud of how Prevnar 13 has competed with Prevnar -- PCV15. I think the important thing here to realize is that given the ACIP recommendation that we've just got for Prevnar peds, what we are beginning to see now is a sort of reversal of that decline and the reclaiming of market share.

    當然,在兒科領域也是如此,由於我們從 100% 佔據市場,到今天我們與 PCV15 分享部分市場份額。但我只是想提醒大家,這是意料之中的事,我們也處於我們所認為的狀態。因此從這個角度來看,我們也為 Prevnar 13 與 Prevnar-PCV15 的競爭感到非常自豪。我認為這裡需要認識到的重要一點是,鑑於我們剛剛收到的 ACIP 對 Prevnar 兒科藥物的建議,我們現在開始看到這種下滑趨勢的逆轉和市場份額的重新奪回。

  • And so we have -- the fact that we've seen some accounts purchasing PCV20 peds now, we've seen some account switching from PCV15 to our own Prevnar 20, the fact that our federal contracts had added Prevnar 20 to their register, which means that public vaccinations can begin. And then maybe the one thing I will mention about Prevnar peds which is unique compared to any other pneumococcal vaccine, which is that we were given the recommendation to vaccinate adult -- well, kids 2 to 18 immunocompromised. So that is a whole new population that we've never had before.

    事實上,我們已經看到一些帳戶現在購買 PCV20 兒童疫苗,我們看到一些帳戶從 PCV15 轉換為我們自己的 Prevnar 20,事實上我們的聯邦合約已將 Prevnar 20 添加到他們的登記冊中,這意味著公眾可以開始接種疫苗。然後,也許我要提到的一點是,Prevnar 兒童疫苗與其他肺炎鏈球菌疫苗相比是獨一無二的,那就是我們建議為成人(也就是 2 至 18 歲免疫功能低下的兒童)接種疫苗。所以,這是一個我們以前從未有過的全新人口群體。

  • So when you kind of bring all of this together and you factor that this quarter alone, Prevnar franchise generated $1.3 billion in revenue, just this 1 quarter, I think that order of magnitude gives you a sense of the scale and the competitiveness of our portfolio, and we're really excited about what Prevnar can do over the next coming quarters.

    因此,如果將所有這些因素綜合起來,並考慮到僅在本季度,Prevnar 特許經營就創造了 13 億美元的收入,僅這一季度,我認為這個數量級可以讓您了解我們產品組合的規模和競爭力,我們對 Prevnar 在接下來的幾個季度中能取得的成績感到非常興奮。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • And that is under the competition of PCV15 which I think was around $150 million, if I'm not mistaken. Chris, can you please speak about the CDK4 and the franchise in general over there?

    這是在與 PCV15 的競爭下,如果我沒記錯的話,我認為其價值約為 1.5 億美元。克里斯,你能談談 CDK4 和那裡的特許經營權嗎?

  • Chris Boshoff - Executive VP and Chief Oncology Research & Development Officer

    Chris Boshoff - Executive VP and Chief Oncology Research & Development Officer

  • Thank you for the question. So as you know, ER+ breast cancer is the most common cancer globally for women, and we're very proud that we can build on our leadership in cell cycle inhibition with IBRANCE. And with 3 first-in-class potential assets, CDK4-specific inhibitor, CDK2-specific inhibitor and a KAT6-specific inhibitor, all 3 with significant potential to transform treatment in the future for ER+ breast cancer.

    感謝您的提問。如你所知,ER+乳癌是全球女性最常見的癌症,我們非常自豪能夠透過 IBRANCE 鞏固我們在細胞週期抑制領域的領導地位。並擁有3種同類首創的潛在資產,即CDK4特異性抑制劑、CDK2特異性抑制劑和KAT6特異性抑制劑,這3種藥物都具有巨大潛力,並有望在未來改變ER+乳癌的治療方法。

  • For CDK4, we have seen more complete and continuous CDK4 target coverage and potentially improved tolerability due to reduced CDK6 inhibition. And as Mikael has pointed out, CDK6 leads to the hematological vulnerability. We know that epithelial cells specifically, highly expressed CDK4, and that's why it's so important to specifically target CDK4. And what we've seen, as Mikael has pointed out, is grade 3 neutropenia of 15% with our CDK4 inhibitor and that's versus 60% as expected with other CDK4/6 inhibitors.

    對於 CDK4,我們看到了更完整和連續的 CDK4 標靶覆蓋,並且由於 CDK6 抑制的減少而潛在地提高了耐受性。正如 Mikael 指出的那樣,CDK6 會導致血液學脆弱性。我們知道上皮細胞特別高表達 CDK4,這就是為什麼專門針對 CDK4 如此重要。正如 Mikael 指出的那樣,我們的 CDK4 抑制劑的 3 級中性粒細胞減少症發生率為 15%,而其他 CDK4/6 抑制劑的預期發生率為 60%。

  • We've also not noted any grade 3 diarrhea. And again, that's very different from what you know from some of the other CDK4/6 inhibitors. We're accelerating our registration strategy with the first study in second-line post CDK4/6, where we've recently shown 30% overall response rate in a heavy pretreated population, and we're also starting populations with CDK4 plus CDK2 as well as CDK4 with our potential next-generation backbone, ARV-471 or vepdegestrant, which we are codeveloping with Arvinas.

    我們也沒有發現任何 3 級腹瀉。再說一遍,這與您所了解的其他一些 CDK4/6 抑制劑非常不同。我們正在加速我們的註冊策略,第一項研究針對的是 CDK4/6 後的二線治療,我們最近在該研究中顯示,在接受過大量治療的人群中,總體反應率達到 30%,而且我們也開始研究 CDK4 加 CDK2 以及 CDK4 人群,以及我們潛在的下一代骨幹藥物 ARV-471 或 vepdegvin。

  • Operator

    Operator

  • Next, we have Tim Anderson with Wolfe Research.

    接下來是 Wolfe Research 的 Tim Anderson。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • If I could go back to the COVID guidance. Investors have been cautious not only on the level of your prior guidance for '23 but also the shape of the future revenue curves beyond '23. So my question is on the latter, let's say, for the future curve. Are you confident still in saying that 2023 should be the trough, and then you'll rebound to some higher level of sales in 2024 and beyond and see kind of continued growth from that point forward? Or is that now more uncertain, too?

    如果我可以回到 COVID 指導。投資人不僅對您之前對23年的預期水準持謹慎態度,而且對23年以後的未來收入曲線的形狀也持謹慎態度。所以我的問題是關於後者,比如說,關於未來曲線。您是否仍然有信心說 2023 年應該是低谷,然後您的銷售將在 2024 年及以後反彈到更高的水平,並從那時起看到持續的增長?或者現在這也更不確定了?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. Thank you. Yes, I think that this year's utilization at the marketplace will form the basis that we can predict reliably for the next years. I don't think it will be any much different because there will be no different catalyst in the marketplace. Vaccination rates would settle and then the treatment and infection rates also will be, after a new year, indicative of what we should expect periodically.

    是的。謝謝。是的,我認為今年的市場利用率將為我們可靠地預測未來幾年奠定基礎。我認為不會有太大不同,因為市場上不會有不同的催化劑。疫苗接種率將會穩定下來,新的一年之後,治療和感染率也將定期預示我們應該期待什麼。

  • Clearly, we will have to deal with some inventories movements and this year was a transitioning year because we are going to give prices, and we are going to absorb some of inventories, et cetera. So that should inform the accurate number for '24 and beyond, but should be the base and likely should be higher than what we should see this year. But that, provided that we have reasonable vaccination and treatment range of PAXLOVID. So that's why I say that let's wait to see what will be the actual in this year. And particularly, what will be the utilization, as I said. Because next year, all these inventories and price adjustment things will be very clear what it will be. So thank you very much for the question.

    顯然,我們將不得不處理一些庫存變動,今年是一個過渡年,因為我們將給出價格,我們將吸收一些庫存等等。因此,這應該可以告知 24 年及以後的準確數字,但應該是基礎,並且可能應該高於我們今年看到的數字。但前提是我們有合理的PAXLOVID疫苗接種和治療範圍。所以我說讓我們拭目以待,看看今年的實際情況。具體來說,正如我所說,其用途是什麼。因為明年,所有這些庫存和價格調整的事情將會非常清楚。非常感謝您的提問。

  • Operator

    Operator

  • Our next question will come from Carter Gould with Barclays.

    我們的下一個問題來自巴克萊銀行的卡特·古爾德。

  • Carter Lewis Gould - Senior Analyst

    Carter Lewis Gould - Senior Analyst

  • Thanks for all the transparency on your thought process on the COVID side. Plenty great questions asked this morning. I guess one I wanted to -- didn't get addressed is you out-licensed your TL1A late last year. Your partner, then turns around and sells it for quite substantially more. I guess -- so to be a bit provocative, Albert, were Pfizer shareholders well served by this course of events? I would love to give you the opportunity to address that publicly.

    感謝您對 COVID 方面思考過程的透明化。今天早上提出了許多很好的問題。我想問的一個問題——但沒有得到解決——是你在去年年底超出了 TL1A 的授權範圍。然後,你的合作夥伴轉而以高得多的價格將其賣掉。我想──阿爾伯特,這麼說有點挑釁,輝瑞公司的股東是否從這事件的發展中獲益了呢?我很樂意給你機會公開解決這個問題。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, Carter, for giving us this opportunity. And also thank you for recognizing with Roivant. So I think that's very important thought, particularly when there's uncertainty. We should all know what the scenarios and the parameters are and what the actions that could be potentially triggered with different scenarios. Now let's go to TL1A and let's see what is the situation. Aamir, have we served the shareholders to the best of our knowledge or not?

    謝謝卡特給我們這個機會。也感謝您對 Roivant 的肯定。所以我認為這是非常重要的想法,特別是在存在不確定性的情況下。我們都應該知道場景和參數是什麼,以及不同場景可能觸發哪些動作。現在我們就去TL1A看看情況怎麼樣。阿米爾,我們是否盡我們所能為股東提供服務了?

  • Aamir Malik - Executive VP & Chief Business Innovation Officer

    Aamir Malik - Executive VP & Chief Business Innovation Officer

  • Thanks for the question, Carter. And obviously I'm not going to comment on the rumors and speculation or the potential prices attached to different transactions. What I will say is we're very pleased with our TL1A Telavant partnership with Roivant. And we do think shareholders were well served. So as a reminder, why we entered this. We entered this as an R&D portfolio prioritization decision.

    謝謝你的提問,卡特。顯然,我不會對謠言和猜測或不同交易的潛在價格發表評論。我想說的是,我們對與 Roivant 的 TL1A Telavant 合作感到非常高興。我們確實認為股東得到了良好的服務。回想一下,我們為何進入這個領域。我們將其作為研發組合優先決策。

  • So from time to time, we make decisions as part of our disciplined process to our partner R&D programs, where we think it is better to share the risk or the cost with a partner. And in this case, Telavant, covers all of the R&D costs going forward. And that frees up significant R&D capacity for Pfizer to invest in high priority programs. But we still retain value in this program in 3 different ways. We had a 25% equity stake in Telavant, we have full ex-U.S. and ex-Japan rights and we earned royalties on the U.S. and Japan sales. So taken together, this collaboration allows us to keep more than 50% of the total value of TL1A with 0 incremental R&D spend. And for a Phase 2 program, we feel this is a very sound move for Pfizer shareholders.

    因此,我們時常會根據嚴謹的流程對合作夥伴的研發專案做出決策,認為最好與合作夥伴分擔風險或成本。在這種情況下,Telavant 將承擔今後所有的研發成本。這將釋放大量研發能力,使輝瑞公司可以投資於高優先級專案。但我們仍透過三種不同的方式保留該計劃的價值。我們擁有 Telavant 25% 的股權,我們擁有美國以外的全部股權。以及日本以外的權利,並且我們從美國和日本的銷售中獲得了版稅。總的來說,此次合作讓我們能夠在不增加研發支出的情況下保留 TL1A 總價值的 50% 以上。對於第二階段計劃,我們認為這對輝瑞股東來說是一個非常明智的舉措。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. Mikael, anything to add here?

    是的。米凱爾,還有什麼要補充的嗎?

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • Aamir said it so well. I just wanted to punctuate among the very many options, we have strong platform in bispecific in many therapeutic areas, including immunology and we do have TL1A p40 antibody. That would be very interesting, where we own even greater shares. We have triple specifics that are going into atopic dermatitis. So this just punctuates it. Even in the very same therapeutic area, we have so many things going on. And near term, we expect soon approval for etrasimod and another readout that would go on. So a lot to start there.

    阿米爾說得很好。我只是想在眾多選擇中強調一下,我們在許多治療領域都有強大的雙特異性平台,包括免疫學,而且我們確實有 TL1A p40 抗體。那將會非常有趣,我們擁有更多的股份。我們有三種針對異位性皮膚炎的具體方法。這只是強調了一下。即使在同一個治療領域,我們也有很多事情要做。並且在短期內,我們預計 etrasimod 很快就會獲得批准,並將會有另一份報告發布。因此有很多事情需要從那裡開始。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you. Thank you, Mikael. Don't tip competition too much about what we have in our pocket.

    謝謝。謝謝你,米凱爾。不要讓競爭對手過度知道我們的口袋裡有多少錢。

  • Operator

    Operator

  • Next, we have Steve Scala with Cowen.

    接下來是 Cowen 公司的 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • I just have an observation than a question, but the observation is that it's still not clear what has changed in your long-term COVID expectations versus when you first gave the $30-billion guidance 6 months ago, since in the prior 6 months, nothing really has changed other than FDA action, which doesn't impact the long term. So that's just an observation.

    我只是有一個觀察而不是一個問題,但觀察是,與 6 個月前您首次給出 300 億美元的指導相比,目前仍不清楚您對長期 COVID 的預期發生了什麼變化,因為在之前的 6 個月裡,除了 FDA 的行動之外,什麼都沒有改變,而這不會影響長期前景。這只是一種觀察。

  • But my question is on VYNDAQEL. VYNDAQEL has become a very important franchise, yet its exclusivity is not long in either the U.S. or the EU. Are there any strategies to get around the LOEs? Or is it simply similar to Eliquis where post LOEs, Pfizer will move on to other products?

    但我的問題是關於 VYNDAQEL 的。 VYNDAQEL 已成為一個非常重要的特許經營商,但其在美國和歐盟的獨家經營期並不長。有沒有什麼策略可以避開 LOE?或者它只是與 Eliquis 類似,在 LOE 之後,輝瑞會轉向其他產品?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. So why don't you take the question, Angela?

    是的。那麼安琪拉,你為什麼不回答這個問題呢?

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Yes. Well, it is, as you say, an incredibly important product, and we're just so proud of the fact that it's still growing 40-something percent this quarter. I think when it comes to LOEs, just from the perspective of how we needed, our composition of matter patent expires in 2024, but we have patent term extensions that get us through December of 2028. In the EU, it's 2026. In Japan, it goes right up to 2029.

    是的。嗯,正如您所說,這是一款非常重要的產品,我們為它本季仍保持 40% 以上的成長而感到自豪。我認為,就 LOE 而言,僅從我們需要的角度來看,我們的物質成分專利將於 2024 年到期,但我們的專利期限可以延長至 2028 年 12 月。在歐盟,這個期限是 2026 年。在日本,這個期限一直到 2029 年。

  • So actually, I feel like we still have a good runway as it pertains to this product, more diagnoses that we need to do and more patients that we can capture on to VYNDAQEL, especially with the incredibly competitive and differentiated profile that we have. As you say, we're always, and working with Aamir, looking at opportunities as to what might be good fit into -- what might fit well into this franchise, in this portfolio. But I guess from my perspective, with or without it, we see an incredibly strong opportunity for us to continue to capture growth.

    因此實際上,我覺得就這款產品而言,我們仍然擁有良好的發展空間,我們需要做更多的診斷,並且可以透過 VYNDAQEL 吸引更多的患者,尤其是考慮到我們極具競爭力和差異化的產品組合。正如你所說,我們一直在與阿米爾合作,尋找機會,看看什麼可能適合這個系列,以及什麼可能適合這個投資組合。但我想從我的角度來看,無論有沒有它,我們都看到了一個繼續實現成長的極其強大的機會。

  • Operator

    Operator

  • Next question comes from David Risinger with Leerink Partners.

    下一個問題來自 Leerink Partners 的 David Risinger。

  • David Reed Risinger - Senior MD

    David Reed Risinger - Senior MD

  • So my question is on Pfizer's mRNA flu vaccine candidate, please. And Sanofi had stated at its recent Vaccines Analyst Day that first-generation mRNAs against flu will not deliver sufficient strain B efficacy given mRNA technical issues in targeting strain B. So could you just comment on that and your expectations for your vaccines' southern hemisphere strain B efficacy results later this year?

    我的問題是關於輝瑞的 mRNA 流感候選疫苗。賽諾菲在最近的疫苗分析師日上表示,由於 mRNA 在針對 B 株病毒方面存在技術問題,第一代抗流感 mRNA 無法對 B 株病毒產生足夠的療效。那麼您能否就此發表評論,並展望一下今年稍後您們疫苗對南半球 B 株病毒療效結果的預期?

  • I know that there wasn't the emergence of strain B in the northern hemisphere, but I'm curious about your expectations for demonstrating that strain B efficacy in the southern hemisphere. And then in addition, if you could just comment on your expected reactogenicity profile for mRNA flu versus COMIRNATY's reactogenicity profile?

    我知道北半球沒有出現 B 株,但我很好奇您對在南半球證明 B 株功效的期望。另外,您是否可以評論一下 mRNA 流感的預期反應原性特徵與 COMIRNATY 的反應原性特徵?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much, David. Very good questions. Mikael, so our -- the technical issues that Sanofi is having, are we experiencing as well?

    非常感謝,大衛。非常好的問題。米凱爾,那麼賽諾菲遇到的技術問題我們也遇到了嗎?

  • Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

    Mikael Dolsten - Chief Scientific Officer and President, Pfizer Research and Development

  • Well, I think the difference between maybe the pioneering mRNA compound is Pfizer and of course there is Moderna that have worked on this technology many years. We have ourselves in 5 years into it and make ample improvement across the entire mRNA chain. And I think it just gives us a big leg up and world experience we had with COVID vaccine. So I can't really comment on the issues that Sanofi are facing. I share a much more positive -- I have a much more positive outlook that we have in our capability to design mRNA vaccines that will be powerful against flu A and also against flu B.

    嗯,我認為也許先驅 mRNA 化合物是輝瑞公司,當然還有多年來一直致力於這項技術的 Moderna 公司,這兩者之間的差異在於。我們花了 5 年時間對整個 mRNA 鏈進行了充分的改進。我認為這為我們在 COVID 疫苗研發方面提供了巨大的優勢和全球經驗。所以我無法對賽諾菲面臨的問題發表評論。我對我們設計能夠有效對抗甲型流感和乙型流感的 mRNA 疫苗的能力持更正面的看法。

  • And let's wait. Let's -- we accumulate data and see the outcome, but I'm optimistic about that and realize it's a field that requires a lot of capability [vendor] with moderate reactogenicity. The flu reactogenicity has actually been moderate, been really good. So that's not an issue at all at end of the doses that we have been testing in young or older patients.

    讓我們等待吧。讓我們——累積數據並觀察結果,但我對此感到樂觀,並意識到這是一個需要大量能力(供應商)和中等反應原性的領域。流感反應原性其實一直是中等的,非常好。因此,在我們對年輕或年長患者進行測試的劑量結束時,這根本不是問題。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you for clarifying, Mikael.

    謝謝你的澄清,米凱爾。

  • Operator

    Operator

  • Next, we have Andrew Baum with Citi.

    接下來是花旗的安德魯·鮑姆 (Andrew Baum)。

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

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • Could you talk about the impact of price negotiation under the IRA? Expressly, could you talk to whether you'll be able to collapse the rebate to PBMs in order to offset the impact of, let's say, Eliquis' price reduction, following the price negotiations and therefore, protect your earnings? Or do you think you'll have to still pay the PBMs that kind of a flash even though they're being able to buy the drug at a much reduced price -- or fund the drug at a much reduced price?

    您能談談 IRA 下價格談判的影響嗎?明確地說,您能否談談您是否能夠降低對 PBM 的回扣,以抵消 Eliquis 降價的影響,從而在價格談判後保護您的收益?或者您認為,即使 PBM 能夠以更低的價格購買該藥品,或者以低得多的價格資助該藥品,您仍然必須向他們支付那麼多費用?

  • And then separately for Mikael, given the recent acquisition of Seagen, to what extent -- or planned acquisition of Seagen, to what extent do you believe that there is a potential to review your existing pipeline in order to make room or further optimize your R&D spend to put behind Seagen's additional assets?

    然後對於 Mikael 來說,考慮到最近對 Seagen 的收購,或者計劃收購 Seagen,您認為在多大程度上有可能審查您現有的管道以騰出空間或進一步優化您的研發支出以支持 Seagen 的額外資產?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes. So why don't we go first to answer about what IRA will mean in terms of changing the rebates, et cetera, which it's quite a new situation. So we have to see how it plays. But if you want to speak a little bit about it, Angela?

    是的。那麼我們為什麼不先回答 IRA 在改變退稅等方面意味著什麼呢,這是一個相當新的情況。所以我們必須看看它如何發揮作用。但是如果你想稍微談論一下這個,安琪拉?

  • Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

    Angela Hwang - Chief Commercial Officer & President of Global Biopharmaceuticals Business

  • Yes, sure. So that's exactly right, Albert. I think there's just -- it's a new policy and lots to understand in terms of how it's going to play out. As you say, there will be price negotiations, but at the same time, I think that what we also have to remember, Andrew, is that there's a mitigating factor of the fact that more patients likely will be able to get on Eliquis because of the co-pay threshold and that sort of cap we're going to have as a function of IRA.

    是的,當然。阿爾伯特,這是完全正確的。我認為這是一項新政策,關於其將如何實施還有很多需要了解。正如你所說,將會有價格談判,但與此同時,我認為,安德魯,我們還必須記住,由於共同支付門檻和我們將根據 IRA 設定的上限,更多的患者可能會能夠使用 Eliquis,這是一個緩解因素。

  • And so I think it's a dynamic situation. There's lots for us to consider as it pertains to pricing, rebates, but also patient utilization of the drug and all of this will play out. I guess, as it pertains specifically also to Eliquis, just to remind everyone that though it's obviously one of our largest drugs, its LOE will be around that '26 timeframe. So whatever the impact is, will not be long lasting on our portfolio because it's losing patent anyway around that time.

    所以我認為這是一個動態的情況。我們需要考慮很多因素,包括定價、回扣,以及病人對藥品的使用情況,所有這些都將發揮作用。我想,因為它也特別適用於 Eliquis,只是提醒大家,雖然它顯然是我們最大的藥物之一,但它的 LOE 將在 26 年左右。因此,無論其影響是什麼,都不會對我們的投資組合產生長期影響,因為它無論如何都會在那時失去專利。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much, Angela. It's an evolving environment so we need to really go see it. Also, Andrew, very quickly on the pipeline issue. We have made very clear, but the Seagen acquisition will mean nothing to the pipeline assets. So no pipeline assets will be eliminated or reduced or increased as a result of -- actually, would be increased because of the combinations, but will not be any reductions on pipeline assets as a result of this acquisition.

    非常感謝,安吉拉。這是一個不斷發展的環境,所以我們需要真正去觀察它。此外,安德魯,非常快速地談論管道問題。我們已經說得很清楚了,但 Seagen 的收購對管道資產來說毫無意義。因此,不會因為此次收購而削減、減少或增加任何管道資產——實際上,管道資產會因為合併而增加,但不會導致管道資產減少。

  • Operator

    Operator

  • Next, we have Chris Schott with JPMorgan.

    接下來是摩根大通的克里斯·肖特 (Chris Schott)。

  • Christopher Thomas Schott - Senior Analyst

    Christopher Thomas Schott - Senior Analyst

  • Just a 2-parter on COMIRNATY. Can you just help me a little bit in terms of -- I guess with the updated vaccine being commercialized in September, how much of your remaining COVID revenue should we think about in 3Q versus 4Q? And I'm just trying to get my sense of when we get this 3Q update, will that be based on the sales we're seeing in the quarter? Or more your interpretation of the trend we're seeing for vaccinations? So just setting expectations. And the second part was on the EU contract renegotiation. Just any additional color you can provide on how different, I guess, the terms end up being for 2023 relative to what was reflected in the 2023 guidance?

    這只是 COMIRNATY 上的兩個部分。您能否幫我一點忙——我想,隨著新疫苗在 9 月商業化,我們應該考慮第三季和第四季剩餘的 COVID 收入有多少?我只是想知道,當我們獲得第三季更新時,它是否會基於我們在本季看到的銷售情況?或者您對我們所看到的疫苗接種趨勢的更多解讀?所以只是設定期望。第二部分是關於歐盟合約重新談判。您能否提供一些額外的信息,說明 2023 年的條款與 2023 年指引中反映的條款有何不同?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much. I can take it very quickly. Look, if you see, we will have basically July, August, September in the third quarter. So the vaccinations, with the new, would start in September, hopefully, of course. What we expect is that we will have approval by the end of August. And we are ready with products already now. So we have -- so the production will not be an issue.

    非常感謝。我可以很快拿到它。你看,如果你看的話,第三季基本上會有七月、八月、九月。因此,新疫苗的接種預計將於 9 月開始。我們預計將於 8 月底獲得批准。現在我們的產品已經準備就緒。所以我們有——所以生產不會成為問題。

  • So normally, we should have also in Q3, most of it in Q4. But what really will clarify us at the end of Q3 plus also the month that takes after Q3 until we give -- we present our Q3 results, it is really the vaccination rates, right? That is what will inform. And then price, right? Because everything after all, way better working at price. So very big part of this uncertainty for COMIRNATY will go away.

    因此,正常情況下,我們也應該在第三季實現這一目標,大部分目標在第四季實現。但是,在第三季末以及第三季之後的一個月直到我們公佈第三季結果之前,真正能讓我們清楚的是疫苗接種率,對嗎?這就是要告知的內容。然後是價格,對嗎?因為畢竟一切東西的價格都比較划算。因此,COMIRNATY 面臨的很大一部分不確定性將會消失。

  • On the EU contract renegotiation, I don't know if you noticed, I did say that when we gave our guidance, we were expecting that we will have incorporated assumptions, that we will renegotiate the new contract and our assumptions, we're assuming that we will do over 3 years. Now we did over 4 years, which that creates pressure to our guidance, but then we had some contracts that we didn't expect guidance in Latin America, particularly, that offset very big part of that. So that's why there's no -- but by itself, it's not a reason to change the guidance one way or another. Really, as I said, vaccination rates, it is what will define what is the potential of this vaccines for the years to come. Thank you very much, Chris.

    關於歐盟合約重新談判,我不知道您是否注意到,我確實說過,當我們給出指導時,我們預計我們將納入假設,我們將重新談判新合約和我們的假設,我們假設我們將在 3 年內完成。現在我們已經完成了 4 年多的工作,這給我們的指導帶來了壓力,但是後來我們簽訂了一些合同,特別是在拉丁美洲,我們沒想到指導會如此,這抵消了很大一部分。這就是為什麼沒有——但就其本身而言,這並不是以某種方式改變指導的理由。確實,正如我所說,疫苗接種率將決定未來幾年疫苗的潛力。非常感謝,克里斯。

  • Operator

    Operator

  • Next, we have Rajesh Kumar with HSBC.

    接下來是匯豐銀行的 Rajesh Kumar。

  • Rajesh Kumar - Analyst

    Rajesh Kumar - Analyst

  • Just one for me. You're doing a lot of acquisitions. You've done a large one, Seagen, recently. It's not completed, but as we look forward, how do you think the -- what are the sort of integration challenges you see both on the execution, commercial side but also on the scientific side? What are the things that get you excited versus worried?

    對我來說只有一個。你們正在進行很多收購。 Seagen,你最近做了一件大事。它還沒有完成,但展望未來,您認為在執行、商業方面以及科學方面面臨哪些整合挑戰?哪些事情令您興奮和擔心?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • For the Seagen acquisition, right? Let me...

    為了收購 Seagen 吧?讓我...

  • Rajesh Kumar - Analyst

    Rajesh Kumar - Analyst

  • But you had multiple acquisitions before that as well. So just -- you've got multi-integrations going on sort of, that's why I'm asking the question.

    但在此之前你們也進行過多次收購。所以只是——你已經進行了多重集成,這就是我問這個問題的原因。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Exactly. Exactly. Yes. So let me start with what excites us with Seagen and I think it's the science behind this company. The ADCs are playing a key role right now, more and more in our research and in our fight against cancer. And Seagen has 1 of the 2 leading platforms and we believe it's actually a better one. So I think that excites me a lot.

    確切地。確切地。是的。首先讓我來談談 Seagen 令我們興奮的地方,我認為這是這家公司背後的科學。 ADC 在我們的研究和對抗癌症的過程中發揮著越來越重要的作用。 Seagen 擁有兩個領先平台中的其中一個,我們相信它實際上是一個更好的平台。所以我認為這讓我非常興奮。

  • Also what excites me a lot is that Seagen was able to achieve all this greatness with limited results, relatively compared to what we are bringing on the table. And what we are bringing on the table on the results front, of course, is not only the capital but also a significant expertise on designing the molecules. And particularly in the small molecules, we are very, very, very good. So when it speaks about payloads, I think we can contribute significantly into that.

    同樣讓我興奮的是,與我們相比,Seagen 能夠以有限的成果實現所有這些偉大的成就。當然,我們在成果方面所帶來的不僅是資本,還有設計分子的豐富專業知識。特別是在小分子領域,我們的表現非常非常出色。因此,當談到有效載荷時,我認為我們可以為此做出重大貢獻。

  • Secondly, we are thinking that there is such a nice way of being able to commercialize those products of Seagen, but already in the market or will come because as we look at global presence, that Seagen is lagging. And also in the U.S., we will almost triple our resources once the whole thing is integrated. So there is a lot of things to be excited.

    其次,我們認為有一個很好的方法可以將 Seagen 的產品商業化,但是該產品已經上市或即將上市,因為從全球影響力來看,Seagen 已經落後了。而且在美國,一旦整個系統整合完成,我們的資源將增加近三倍。因此有很多事情值得興奮。

  • Now as you rightly pointed out, things happening, integrations, that we need to be very aware. And not only we -- we do have our fair share of things that we did wrong in the past and we have our fair share of things that we did right in the past. So I know what is extremely, extremely important is to make sure that, first of all, there will be no cultural clash as we are putting together the 2 organizations. To that end, we are very, very lucky because oncology companies tend to have very, very similar (inaudible), the oncology companies.

    正如您正確指出的那樣,我們需要非常清楚正在發生的事情、正在發生的整合。而且不只是我們——我們過去確實做錯了一些事情,也做對了一些事情。因此我知道極其重要的是確保在我們組建兩個組織時不會發生文化衝突。為此,我們非常非常幸運,因為腫瘤學公司往往有非常非常相似的(聽不清楚),腫瘤學公司。

  • And that was saying that even the chemistry of our scientists compared to Seagen's scientists. Actually, where it is really evident it is how many of the great scientists of Seagen raise their hand to join Chris' leadership team as we are going forward. And those scientists will have published this information who will be coming from Seagen. Actually, many of them will lead the global oncology business, not only our past acquisition, not only the Pfizer one, but they will lead the global -- not only the Seagen one, but the global, which is Seagen plus core.

    這就是說,我們的科學家的化學反應甚至與 Seagen 的科學家相比。實際上,真正明顯的是,在我們前進的過程中,有多少 Seagen 的偉大科學家舉手加入 Chris 的領導團隊。來自 Seagen 的那些科學家將會發表這些資訊。實際上,他們中的許多人將領導全球腫瘤業務,不僅是我們過去收購的公司,不僅是輝瑞公司,而且他們將領導全球——不僅是 Seagen 公司,而且是全球,即 Seagen plus core 公司。

  • The second thing that we need to be very careful it is that we don't slow down things, and we don't increase cost of things. This is something that we have seen when big companies are acquiring small. But many times, cost goes double and the timelines goes also doubled. So that's something that we must avoid. And in order to avoid, we are doing tremendous pre-integration planning to make sure that innovation will be enhanced dramatically after we are putting the 2 together. And I have full trust on, of course, Chris, that is leading this integration, on this planning for months now.

    第二件我們需要非常小心的事情是,不要減慢進度,也不要增加成本。我們在大公司收購小公司時就看過這種現象。但很多時候,成本會加倍,時間也會加倍。所以這是我們必須避免的事情。為了避免這種情況,我們正在進行大量的預整合規劃,以確保在將兩者結合起來之後,創新能力將會顯著提升。當然,我完全信任克里斯,他幾個月來一直在領導這項整合工作和規劃。

  • And last but not least, many times, when you have an integration, it could go wrong and it's good if a CEO, which is the one who can resolve conflicts in a corporation and make decisions fast, has very high visibility on what is happening. So I think very fast. This is our biggest investment for many decades. That's clearly the biggest investment under my watch.

    最後但並非最不重要的一點是,很多時候,當你進行整合時,可能會出錯,而如果 CEO 能夠解決公司內部的衝突并快速做出決策,並且對正在發生的事情有很高的了解,那就太好了。所以我想得非常快。這是我們幾十年來最大的投資。這顯然是我任內最大的投資。

  • And we take it very seriously as one of the most potential exciting opportunities to grow. But also, we are very cognizant that we should make sure that nothing goes wrong. So I'm personally on it. And Seagen is going to be one of our biggest bets as you can see going forward. So we are using all our experience and the best people and I'm very, very pleased. And I'm very, very pleased because chemistry of the 2 teams is unbeatable right now. And they are working like one and they are all coming to see the new Seagen/Pfizer oncology portfolio growing faster than when we were alone.

    我們非常重視它,並認為這是最具潛力的成長機會之一。但同時,我們也非常清楚,我們應該確保一切順利。所以我個人是同意這個觀點的。正如您所看到的,Seagen 將是我們未來最大的賭注之一。因此,我們利用了我們所有的經驗和最優秀的人才,我感到非常非常高興。我感到非常非常高興,因為目前這兩支球隊之間的化學反應是無與倫比的。他們齊心協力,共同努力,共同見證 Seagen/Pfizer 腫瘤學產品組合的新增長速度比我們單獨行動時更快。

  • Operator

    Operator

  • Our last question will come from Michelle Rivera with inThought Research.

    我們的最後一個問題來自 inThought Research 的 Michelle Rivera。

  • Michelle Rivera - Analyst

    Michelle Rivera - Analyst

  • What's the status of the DMD gene therapy program? Have you finalized dosing patients? I read a statement at a recent conference that you finalized screening patients. So I was not sure whether that meant that the trial had been paused. Just some clarity around that and when we should expect data, would be helpful.

    DMD 基因治療計劃的現況如何?您是否已確定患者用藥劑量?我在最近的一次會議上讀到了一份聲明,說你們已經完成了對病人的篩檢。所以我不確定這是否意味著審判已暫停。只要明確這一點以及我們何時應該期待數據,就會很有幫助。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Chris, you were running DMD until recently. Now, you, of course, provided Mikael the responsibility. So can you give us a little bit very quickly what is the status of DMD?

    克里斯,直到最近你還在經營 DMD。現在,你當然賦予了米凱爾責任。那麼您能否快速告訴我們 DMD 的現狀?

  • Chris Boshoff - Executive VP and Chief Oncology Research & Development Officer

    Chris Boshoff - Executive VP and Chief Oncology Research & Development Officer

  • Yes, thank you. So the -- as I mentioned earlier, the clinical trial has now completed enrollment. As you pointed out, the halt dosing for the last couple of patients due to a protocol amendment, but we're very confident that we will go ahead and have the interim analysis later this year based on the functional end point, which will be substituted also or which will be, yes, with the biomarker data. We'll have both functional data as well as biomarker data later this year, and then the final analysis for the full study in 2024. We've also fully enrolled now the earlier age group, patients between the ages of 2 and 3 years old, 10 patients enrolled in that trial. So yes, we're looking forward to share the data later this year for you.

    是的,謝謝。所以——正如我之前提到的,臨床試驗現在已經完成招募。正如您所指出的,由於方案修改,最後幾名患者的用藥暫停,但我們非常有信心,我們將在今年晚些時候根據功能終點進行中期分析,這也將被替代,或者將使用生物標誌物數據。我們將在今年稍後獲得功能數據和生物標記數據,然後在 2024 年進行全面研究的最終分析。我們現在已經完全招募了早期年齡組的患者,即年齡在 2 至 3 歲之間的患者,共有 10 名患者參加了該試驗。所以是的,我們期待今年稍後與您分享數據。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you very much. In summary, I think we had a solid quarter, continue to invest, to support our unprecedented 19 potential launches in an 18-month period. These are doing very well. The plan is executed as per the timelines. In our pipeline and in value-creating revenue-generating business development opportunities like Seagen, which, as I articulated just in the question before that, it is clearly our big bet and our very, very big opportunity moving forward.

    非常感謝。總而言之,我認為我們度過了一個穩健的季度,並將繼續投資,以支持我們在 18 個月內前所未有的 19 個潛在產品的發布。這些都做得很好。該計劃正按照時間表執行。在我們的產品線中以及在創造價值、創造收入的業務發展機會中,例如 Seagen,正如我在之前的問題中所說的那樣,這顯然是我們的大賭注,也是我們未來非常非常大的機會。

  • Over the next 3 months, we look forward to moving beyond the current uncertainty related to our COVID-19-related revenue. So we have better clarity. And by the end of the year, we'll have -- the uncertainty will be removed almost at last. To that extent that any adjustments are needed into our cost base for '24 and beyond, we are ready to make. I want to reemphasize that the biggest uncertainty in terms of the long term is vaccination rate. Some short term uncertainties like when commercialization will be, I think it's just a question of time. But the vaccination and treatment rates that we are going to see, I think, will inform what we should expect for the years to come, with only upside with the combination vaccines.

    在接下來的三個月裡,我們期待擺脫目前與 COVID-19 相關收入相關的不確定性。因此我們的認識更加清晰。到今年年底,不確定性幾乎就會消除。如果 2024 年及以後的成本基礎需要進行任何調整,我們都已做好準備。我想再次強調,長期來看最大的不確定性是疫苗接種率。一些短期的不確定性,例如何時商業化,我認為這只是時間問題。但我認為,我們將看到的疫苗接種和治療率將告訴我們未來幾年應該期待什麼,而聯合疫苗只會帶來好處。

  • Putting all these factors together, we remain confident in our ability to deliver a robust operational growth and deliver meaningful shareholder value through the end of the decade and beyond.

    綜合考慮所有這些因素,我們仍然有信心,我們能夠實現強勁的營運成長,並為本世紀末及以後的股東創造有意義的價值。

  • And that, we will bring our call to a close. Thank you for joining us, and have a great rest of your day.

    然後,我們的通話就結束。感謝您加入我們,祝您有個愉快的一天。

  • Operator

    Operator

  • Thank you. Ladies and gentlemen, this does conclude Pfizer's Second Quarter 2023 Earnings Conference Call. We appreciate your participation, and you may disconnect at any time.

    謝謝。女士們、先生們,輝瑞 2023 年第二季財報電話會議到此結束。我們感謝您的參與,您可以隨時斷開連線。