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 年第二季度收益電話會議。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,我想將電話轉給高級副總裁兼首席投資者關係官 Chris Stevo 先生。請繼續,先生。

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

    Christopher J. Stevo - Senior VP & Chief IR Officer

  • Thank you, Chelsea. Good morning. 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。早上好。歡迎參加輝瑞第二季度財報電話會議。今天我們的董事長兼首席執行官 Albert Bourla 博士也加入了我的行列。戴夫·丹頓 (Dave Denton),我們的首席財務官; Mikael Dolsten 博士,輝瑞研發部首席科學官兼總裁。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; Aamir Malik,我們的首席業務創新官; Chris Boshoff 博士,我們的首席腫瘤學研究和開發官;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。本次電話會議的材料以及其他與收益相關的材料位於 pfizer.com 的投資者關係部分,當然,我最喜歡的是我們的前瞻性聲明。請參閱幻燈片 3 上的前瞻性聲明免責聲明以及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 的收益發布中的風險因素和前瞻性信息下找到以及可能影響未來結果的因素。電話會議中的前瞻性陳述存在重大風險和不確定性,僅在電話會議原始日期發表,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.

    這樣,我會將電話轉給艾伯特。

  • 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,感謝您今天加入我們。我們第二季度的財務業績穩健,符合我們的預期。與去年同期相比,非 COVID-19 業務收入增長了 5%。運營總收入下降了 53%,主要是由於 PAXLOVID 和 COMIRNATY 的預期收入下降。即使出現這些下滑,我們的 COVID-19 產品組合仍然是業務的重要貢獻者,本季度的合併收入超過 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 6 個月,全球有超過 3.56 億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.

    我們繼續朝著推出數量空前的新產品或適應症的目標取得進展。事實上,輝瑞公司已完成其在 18 個月內推出 19 種新產品或適應症的目標的一半以上。除了 2023 年之前發生的 6 項批准和 5 項啟動外,我們在 2023 年前 6 個月內還有 6 項批准和 4 項啟動。對於 2023 年下半年,我們預計將有 6 項批准和 6 項額外啟動,其中包括 2 項批准和 6 項啟動。七月進行的發射。

  • 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 derisked 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 項發布,如果獲得批准和建議,將在大約 18 個月內將新發布總數增加到 19 項。正如您在此圖表中所看到的,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度末。然後到 2024 年,隨著明年預期發布的額外影響,我們預計 19 項發布的總貢獻會更大。值得注意的是,從技術角度來看,目前 19 種潛在上市產品中的 18 種已經基本上消除了風險,只剩下 1 種是我們的 RNA 流感候選產品。

  • 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 III 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 II 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,我們的管道預計將做出貢獻——在我們討論的 19 年後很久之後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產品的里程碑,這些候選產品有可能成為未來重要的價值驅動因素。其中包括: marstacimab 的 III 期數據,這是一種正在研究用於治療 A 型和 B 型血友病的新型抗體;我們的 B 型血友病基因療法候選藥物的監管備案已被接受;我們在《新英格蘭醫學雜誌》上發表了針對 B 組鏈球菌的孕產婦免疫候選疫苗的 II 期結果;以及來自我們潛在的下一代乳腺癌治療產品線的首次人體數據,包括我們的新型 CDK4、CDK2 和 KAT6 抑製劑。

  • 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 產品組合發表一些評論。眾所周知,在大流行期間,輝瑞通過向世界帶來第一種、使用最廣泛的 COVID-19 疫苗和口服治療藥物,令人印象深刻地展示了我們的研究和製造能力。這些科學突破為控制全球健康危機發揮了重要作用,我們為自己的貢獻感到非常自豪。這些產品今天產生的利潤使我們能夠投資收購 Arena、ReViral、Biohaven 和 Global Blood Therapeutics,我們預計這些產品將在 2030 年共同貢獻約 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,收購 Biohaven 和 Global Blood Therapeutics 已經為我們的運營增長做出了貢獻,而收購 Arena 預計將在今年年底開始產生收入。我們還對收購 Seagen 的計劃感到非常興奮,如果該收購獲得批准,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.

    由於我們的非 COVID-19 收入的積極勢頭,更重要的是,我們的 COVID-19 產品組合的成功,輝瑞的整體收入與我們 2019 年的收入相比呈指數增長,預計剝離 Upjohn 和我們的消費者商業。這使我們能夠增加對研發和 SI&A 的投資,以支持這一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. Clear, 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 方面增加的投資是根據我們 1 月份對 COVID-19 和非 COVID-19 產品所做的某些收入假設確定的。這些假設也已納入我們的 2023 年財務指導中。顯然,與我們其他業務相比,我們的 COVID-19 產品的需求預測存在更高的不確定性。例如,一月份,我們預計今年美國將注射約 1 億劑 COVID-19,其中我們估計輝瑞將佔據 60% 的市場份額。 2023 年前 6 個月,美國註射了 1240 萬劑疫苗。雖然 1240 萬劑疫苗落後於我們之前的預測,但我們的 COVID-19 市場份額超出了我們之前的預期(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發生在 9 月開始的秋季和冬季呼吸道疾病季節,我們預計未來 COVID-19 疫苗接種將遵循這種模式。隨著 FDA 和 CDC 決定要求改變疫苗成分以應對 Omicron XBB.1.5 毒株,COMIRNATY 商業化確切時間的不確定性在很大程度上消除了。當然,假設更新的疫苗在 8 月底獲得批准並上市,我們相信這將使我們能夠在 9 月份將疫苗商業化。

  • 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,當我們成功地重新談判了長期協議後,關於 23 年及以後疫苗收入貢獻的不確定性就被消除了。該協議將商定的數量分攤到四年內。雖然這給今年的銷量帶來了壓力,但我們相信它也為這個重要市場提供了長期的收入確定性。

  • 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.

    與我們在疫苗方面經歷的情況類似,下半年將在我們對 PAXLOVID 長期需求的預期方面發揮更大的作用,PAXLOVID 的使用情況與 COVID-19 感染率密切相關。我們預計新一波的 COVID-19 浪潮將於今年秋天在美國爆發,而我們已經看到的感染率上升也支持了這一預期。顯然,疾病的嚴重程度和人們對治療的渴望也將是因素,以及與美國政府就何時過渡到 PAXLOVID 商業模式進行的持續對話。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很難預測輝瑞在該領域(主要是輝瑞)的未來收入,並因此影響了我們的股價。好消息是,當我們報告第三季度財務業績時,我們將更加清楚和確定地了解我們的 COVID-19 產品在商業市場上的表現。我們預計不確定性將在年底前基本消除。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率和治療率將成為未來幾年趨勢的可靠預測指標,當然,如果流感和 COVID-19 聯合疫苗在未來。

  • 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 過渡到全面商業化的時間應該會變得清晰。儘管存在這種不確定性,今年我們仍將在即將到來的呼吸道疾病季節之前繼續投資於我們的 COVID-19 投資組合。這個非常重要。但考慮到不確定性,我們還準備有能力調整 2024 年的總成本基礎,以適應未來各種 COVID-19 疾病的收入情況。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。戴夫將在講話中提供更多細節。

  • 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,我想分享一下我們計劃收購 Seagen 的一些最新情況,我們相信這將是我們未來成功的主要推動力。 Seagen 的股東最近以壓倒性多數批准了收購計劃,我們已經籌集了交易所需的大部分外部融資。我們還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。與此同時,我們的整合計劃仍在繼續,這將使我們能夠在預計於 2023 年晚些時候或 2024 年初完成交易後立即開始運作,前提是滿足慣例成交條件。

  • Last week, we announced that Chris Boshoff has joined Pfizer's executive leadership team 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) 已加入輝瑞的執行領導團隊,擔任首席腫瘤研發官兼執行副總裁,直接向我匯報。在此職位上,克里斯將領導一個新的端到端腫瘤研發組織,並成為從發現到早期和後期臨床開發的整個腫瘤學流程的單點負責人。這與我們目前疫苗研發組織的結構類似,事實證明該結構非常高效。

  • 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,即為癌症患者提供挽救生命的治療方法,這就是為什麼我很高興在交易結束後,Chris 的腫瘤學領導團隊將包括來自兩家公司的才華橫溢、目標驅動且高效的領導者。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,這一點至關重要,因為在與癌症的鬥爭中,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,核心業務原則之一是相信信任就是一切。我很自豪地與大家分享,近幾個月來,我們獲得了一些精彩的讚譽,這證明了我們與外部利益相關者建立的信任。我們被《美國新聞與世界報導》評為“23-24 年最適宜工作的公司”之一。我們被《新聞周刊》列入 2023 年美國最佳工作場所名單。輝瑞連續第三年在 2023 年殘疾人平等指數中名列前 100 名。我們自己的 Rady Johnson 在 7 月份的全國會議上獲得了“Disability:IN '23 年度執行發起人獎”。最後,我們位於意大利阿斯科利的 PGS 工廠榮獲聯合國“歡迎獎 - 為難民融入工作”。這些認可非常重要,因為它們加強了輝瑞在 COVID-19 大流行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落基山工廠的情況。首先,龍捲風襲來時,沒有同事受重傷,輝瑞公司的所有人都鬆了口氣。儘管如此,不幸的是,我們的設施以及我們許多同事居住的社區都遭受了嚴重破壞。當地領導團隊在應對這一毀滅性事件方面做了令人難以置信的工作。我們正在緊急而謹慎地確定盡快恢復網站的最佳方式,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,我將把它交給戴夫,在戴夫之後,米凱爾將提供我們研發管道的最新情況。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,祝大家早上好。在過去 24 個月裡,輝瑞進行了重要投資,使其走上實現盈利和可持續增長的軌道,特別是在本世紀後半段。我們進行了戰略投資,以擴大我們的商業投資組合和後期產品線,增強我們的市場啟動能力,並通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繼續鞏固輝瑞克服即將到來的 LOE 並推動可持續收入增長的能力,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增長目標,我們正在執行旨在有效部署現金的資本配置策略。我們的戰略集中在三個主要支柱上:首先是對我們的業務進行再投資;其次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。僅在 2023 年上半年,我們就在內部研發上投資了 52 億美元,通過季度股息向股東返還 46 億美元,並為擬議的 Seagen 收購分配了約 430 億美元。第二季度,輝瑞成功完成了 8 期 310 億美元的無擔保債務發行。此次發債的淨收益將用於為 Seagen 收購提供大量資金。新債加權平均收益率為4.93%,加權平均期限為16.3年,符合我們的預期。

  • 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.

    按照全年運行率計算,與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,該公司準備在獲得監管批准後立即完成對 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 交易完成後將去槓桿化我們的資本結構。隨著我們去槓桿化,我們期望回歸更加平衡的資本配置策略,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,我們第二季度的業績穩健,從頂線和底線的角度來看都符合我們的預期,儘管略好於每股收益共識。正如我們指引中的預期,我們第二季度的整體運營收入下降了 53%。收入收縮是由於 PAXLOVID 和 COMIRNATY 銷售額預期下降所致。我們預計這些產品將在今年下半年過渡到商業市場。我們的運營收入增長(不包括新冠病毒產品)與 LY 第二季度相比增長 5%,符合預期,其中 NURTEC 和 Oxbryta 的納入以及 VYNDAQEL 系列的持續增長做出了強勁貢獻。

  • 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 相比運營增長了 20%。我們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當前的盈利水平,但我們專注於最大限度地提高這些產品的長期性能。

  • 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.

    現在轉向利潤,本季度報告的攤薄每股收益下降 77%,至 0.41 美元,而調整後的攤薄每股收益為 0.67 美元,在運營基礎上下降 65%。盈利壓縮率高於收入壓縮率,主要是由於本季度 PAXLOVID 銷售額的急劇和預期收縮。外匯波動再次對我們的業績產生不利影響,與去年相比,第二季度收入減少了約 2.8 億美元或 1%,調整後的稀釋每股收益減少了 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,我們的 2023 年財務計劃已完成一半,我想花點時間思考一下我們在極其獨特且充滿活力的環境中如何執行整個業務。作為一個管理團隊,考慮到產品發布的規模、新冠疫情形勢的持續變化以及所收購資產的持續整合,我們仍然致力於保持透明度並分享我們對不斷發展的市場的評估。

  • 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.

    讓我首先詳細闡述我們 23 年全年的財務指引。我們將收入預期縮小至 670 億美元至 700 億美元之間,並維持全年調整後攤薄每股收益 3.25 美元至 3.45 美元的指導。為了實現更持久、更可預測的非新冠疫情收入,我們將運營收入增長指導範圍更新為 6% 至 8%。從發佈時間的角度來看,我要指出的是,我們 2023 年的大部分發布預計將在 2023 年下半年進行,並且我們的商業化時間表基本保持不變。作為一家公司,我們始終努力實現盡可能最高的收入水平,同時對影響我們前景的關鍵投入保持現實的看法。

  • 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.

    關於老年人 RSV,ACIP 的共同決策建議可能會減緩其近期在美國的採用。此外,最近 TALZENNA 在美國的批准導致患者群體比原計劃更窄。這些因素,加上落基山製造工廠受損的影響,給近期的收入帶來了挑戰。然而,我們預計,隨著 2023 年退出並進入 2024 年,我們將出現積極的收入勢頭。重要的是,相對於我們 2030 年的雄心,我們的非新冠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.

    現在轉向我們難以預測且變化更大的新冠病毒投資組合。今年迄今為止,我們已經為 COMIRNATY 和 PAXLOVID 預訂了略高於 215 億美元全年收入預測的 40%,重要的秋季疫苗接種和呼吸道感染季節即將到來。我們敏銳地意識到,新冠疫情的需求取決於許多不斷變化的市場變量,使得潛在收入結果的範圍變得越來越大,並且難以確定地預測。這些變量包括疫苗接種總體水平和感染率、政府庫存水平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.

    為了公共衛生的利益,並且在重要的秋季即將來臨之際,我們維持今年的新冠肺炎收入前景,同時繼續在可變費用的基礎上進行大量投資,以支持我們在 2023 年的新冠肺炎產品。這些可變投資對於支持我們努力接觸盡可能多的患者,幫助確保高危人群接種疫苗和接受治療,同時保持我們領先的市場份額。我們對通過新冠病毒投資組合取得的成就感到自豪,這使公司能夠進行投資以支持本十年後半段的增長議程。隨著我們對更典型的年度運行率有了更清晰的了解,我們對未來新冠肺炎收入和需求的了解應該會在 2023 年剩餘時間內有所改善。

  • 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.

    我們清楚地意識到,我們 2023 年的利潤前景目前受到支持我們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。我們仍然致力於捍衛和提高我們的整體盈利水平。正如 Albert 之前提到的,我們預計今年秋季 COVID-19 產品的表現將幫助我們更有效地預測未來的銷售業績。為此,如果我們的 COVID-19 收入低於我們的假設,我們準備啟動一項與我們業務的長期收入預測相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,預計將於 2024 年開始產生成果。我們期待在即將舉行的財報電話會議中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,對于輝瑞來說,這是一個非凡的時刻。我們對戰略和實現 2030 年目標的信心和承諾堅定不移。我們將繼續集中精力推動增長,同時提高長期股東價值。

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

    現在讓我把它交給 Mikael。

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

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

  • 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信息,從乳腺癌開始。我們正在努力為雌激素受體陽性乳腺癌提供下一波創新療法。該戰略的支柱有三個:將我們的研究性 CDK4 抑製劑確立為下一代細胞週期治療的支柱,將 vepdegestrant 確立為下一代內分泌治療的支柱;建立新的機制,例如我們正在研究的 CDK2 抑製劑和 KAT6 候選抑製劑作為下一代組合夥伴,以提高療效。

  • 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需要開髮用於轉移性環境的資產,其中 IBRANCE 目前處於領先地位,未滿足的需求很高,其次是有機會擴展到早期乳腺癌,包括 CDK4/6 初治人群和輔助或治療藥物新輔助設置。

  • 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.

    在 ASCO 上展示的來自我們下一代產品組合的 3 種關鍵研究藥物的數據表明,經過大量預處理的乳腺癌患者群體具有抗腫瘤活性。提醒一下,大多數激素受體陽性乳腺癌的 CDK6 表達水平較低,而 CDK4 可能是主要的細胞週期驅動因素。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測監測,這主要是由 CDK6 抑制引起的。在 CDK4/6 抑製劑類別中,大約 30% 至 60% 的患者會出現嚴重的中性粒細胞減少症。

  • On the left, in a Phase I 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.

    左邊,在激素受體陽性 HER2 陰性乳腺癌患者的 I 期劑量遞增研究中,所有這些患者之前都接受過 CDK4/6 抑製劑,使用我們的 CDK4 抑製劑與內分泌治療相結合的治療結果證實,客觀緩解率為 29%,臨床獲益緩解率為 52%,中位無進展生存期接近 25 週。該組合具有良好的耐受性,可以最大程度地抑制 CDK4。我們正在積極規劃 III 期隨機研究。

  • In addition, I'd like to highlight encouraging data from the Phase I 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,我想強調我們的新型 CDK2 抑製劑的 I 期劑量遞增研究的令人鼓舞的數據,該研究顯示出單一療法的活性,包括在先前接受過 CDK4/6 抑製劑的乳腺癌患者中確認的部分緩解。此外,在我們的新型 KAT6 抑製劑作為單一療法以及與內分泌療法聯合治療的乳腺癌患者中,在 I 期試驗中觀察到了持久的經證實的臨床反應。

  • 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.

    現在轉向血癌。 ELREXFIO,也稱為 elranatamab,需要獲得監管部門的批准,預計將成為預期價值數十億美元的特許經營權的支柱。預計 FDA 將於今年就三級復發或難治性多發性骨髓瘤人群的潛在第一個適應症做出決定,我們將繼續推進 MagnetisMM 臨床計劃,以擴展到早期治療領域。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性白血病的潛在突變。

  • 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.

    在這裡,我們展示了 EHA 上公佈的 MagnetisMM-3 試驗中的 ELREXFIO 數據,該試驗針對的是先前未接受過 BCMA 定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 單藥治療的生存率非常有意義,15 個月的總生存率為 57%。在獲得完全緩解的患者中,15 個月的生存率高達 93%,這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廣泛活性的證據,該圖顯示單一藥物的完全緩解率為 35%,在接受 2 至 3 種治療的患者子集中,這一比例上升至 46%。我們正在進行的隨機試驗對新診斷人群的預處理較少。待批准後,ELREXFIO 可能具有關鍵的差異化優勢,例如每個方案的遞增給藥期間住院時間減少 50%,以及延長的給藥間隔,從每週一次改為在第 24 週之後每隔一周給藥一次。

  • 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,marstacimab 的關鍵試驗達到了其主要終點,對年化出血率或 ABR 產生了具有統計學意義和臨床意義的影響。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%。與標準護理療法相比,Marstacimab 提供了獨特的作用機制和給藥方案。如果獲得批准,它有可能成為第一個針對沒有抑製劑的患者的每週一次的 subcu 血友病 B 治療方法,以及第一個以固定劑量在患者友好筆中進行的血友病 A 或 B 治療方法。預計將於 23 年下半年提交監管報告。

  • 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。它最近還收到了歐洲藥品管理局 CHMP 推薦機構的積極意見,但尚未獲得批准。它有可能重新定義斑禿的護理標準。 LITFULO 是首個激酶抑製劑,具有獨特的機制,可抑制 TEC 激酶家族和與斑禿病理生理學有關的短暫 JAK3 通路。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,包括白癜風(正在進行第三階段研究)以及其他潛在的適應症。

  • 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 24 年上半年設定的里程碑方面取得了巨大進展。正如 Albert 指出的,我們最近獲得 FDA 批准 Prevnar 20 用於兒科人群。我們制定了強有力的策略來潛在地改善當前肺炎球菌疫苗提供的保護。我期待在未來幾個季度分享更多相關內容。

  • In addition, we recently published Phase II 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 II 期數據,顯示我們的 B 組鏈球菌母體候選疫苗總體耐受性良好,並產生了強勁的抗體水平。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,候選疫苗可以為免疫母親所生的嬰兒提供有意義的保護。德克薩斯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,強調了我們候選 GBS 疫苗的重要未來前景,這讓我們深受鼓舞。

  • 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針對孕婦使用 RSV 疫苗 ABRYSVO 的積極結果和預期即將做出的監管決定非常吻合。 ABRYSVO 最近收到了歐洲藥品管理局 CHMP 對老年人和孕產婦免疫接種的積極意見,以幫助保護嬰兒。 ABRYSVO 在美國被批准用於老年人,並且正在接受針對孕產婦適應症的監管審查。

  • In addition, we remain excited to see the Phase II data from danuglipron by end of '23, which we expect will enable us to finalize our Phase III plan. Finally, I'll call out the Phase III 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,我們仍然很高興在 23 年底看到 danuglipron 的第二階段數據,我們預計這將使我們能夠最終確定第三階段計劃。最後,我要宣布我們用於治療炎症性肌肉肌病的抗干擾素β候選藥物的 III 期試驗已經啟動,該藥物已獲得 FDA 的快速通道指定。

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

    謝謝。讓我把它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,如果可以的話請給來電者排隊。我們現在至少有 30 分鐘的問答時間。

  • Operator

    Operator

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

    (操作員說明)我們的第一個問題將來自 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?

    這是妮可為羅賓代言的。請向我們提一個簡單的問題。您能否分享一下您預計減緩美國採用率的共同決策會是什麼?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會出現這種情況,並且年銷售額峰值低於之前的預期?您如何看待美國以外的地區銷售可能會受到影響(如果有的話),ACIP 會做出決定嗎?

  • 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。也許安吉拉可以回答這個問題。問題是,您預計呼吸道疾病季節會對 RSV 產生重大影響嗎?我們也預計在美國會產生重大影響嗎?(不包括美國)我們預計會產生任何影響嗎?

  • 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 RSV 老年人疫苗獲得批准感到非常興奮。我對共享臨床決策的看法是,這是朝著我們預期的全面常規建議邁出的一步。所以我認為,看待它的方式是,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.

    我們確實希望隨著更多數據的出現——從我們的臨床計劃中出現,我們將有額外的機會回到 ACIP 並真正獲得我們所希望的常規建議。因此,在未來一年左右的時間裡,當我們收集並最終確定我們的數據時,這確實是我們的預期。因此,它不會改變這種特定疫苗的全部機會。它不會改變峰值。這只是意味著我們需要更長的時間才能達到頂峰,因為我們現在必須採取共同的臨床決策——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.?

    那麼前美國呢?

  • 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,我們有不同的申請。我們能夠同時接種孕產婦和老年人,因此我認為您會看到略有不同的動態,因為在美國,我們的孕產婦疫苗將稍後推出。但在美國以外它們將在歐洲同時推出。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。所以我們會等待。但我認為你所擁有的不同,這確實是一個很大的好處,因為我們同時擁有這兩種跡象。

  • 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.

    非常感謝你,安吉拉。我希望我們滿足了你的要求,羅賓。接線員,請下一個問題。

  • Operator

    Operator

  • Next, we have Umer Raffat with Evercore.

    接下來是 Umer Raffat 和 Evercore。

  • 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成本削減的兩種不同說法。其中之一是它將是整個企業範圍內的,而我認為阿爾伯特在新冠病毒成本基礎中使用了這個詞。所以我只是想調和這2個因素。還有關於danuglipron,如果體重減輕低於十幾歲左右,你就不會繼續前進,這是合理的預期嗎?

  • 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,這將是整個企業範圍內的,但我所說的是,新冠疫情部分將是最大的部分。現在,你需要知道,新冠病毒的研發和 SI&A 成本很大,不是一個小數目。所以,有很多事件。 Mikael,您能談談 Danu 前進的前景嗎?

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

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

  • 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.

    好吧,我們真的很期待獲得數據。如您所知,我們還同時針對修改後的潛在客戶開展了活動。我認為我們確實需要研究數據的整體性、它在糖尿病重要代謝許可方面的表現、它實現您提到的減肥的能力,當然還有它的總體耐受性。這三個因素使藥物的性能變得更加複雜。

  • 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.

    我仍然樂觀地認為此類口服藥物可以對減肥產生深遠的影響。當然,人們可能需要稍微注意一下,不要過度減肥,因為您在公共媒體上也看到了一些關於減肥可能產生的副作用的擔憂。因此,我們將真正整合所有這些數據並做出決定,我們非常期待那一刻的到來。

  • Operator

    Operator

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

    我們的下一個問題將來自 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?

    有點像 Umer 的後續行動,我想重點關注 GLP-1 特許經營權。考慮到安全性、每日兩次給藥和功效,您能否談談目前形式的 danuglipron 的競爭狀況?也許可以提醒我們時間表,以便有可能獲得更多有關該資產每日一次的配方的信息?

  • 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 of Worldwide Research, Development & Medical

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

  • 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 III 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。正如我在準備好的發言中所說,我們預計今年下半年會出現數據。我們絕對感到鼓舞並相信,在不良事件方面,它與我們停止使用的藥物lotiglipron有著不同的特點。所以我們不認為這是一個問題。我還談到,我們將匯總所有數據,以待讀出,準備潛在的第三階段計劃。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,我們期待在本季度與您分享更多數據和更多計劃。感謝您的極大興趣。這對我們很重要。

  • Operator

    Operator

  • Next, we have Terence Flynn with Morgan Stanley.

    接下來請來摩根士丹利的特倫斯·弗林。

  • 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?

    也許對我來說是2個。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。回顧新冠疫情之前的情況,該公司的股價在 30% 的中高區間徘徊。那麼,當您給我們一些參數時,我們應該如何考慮這個問題,但也許如何考慮穩態?

  • And then on the messenger RNA Phase III 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 Messenger RNA III 期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,Mikael,我想知道您是否可以討論一下數據的時間安排並幫助制定預期。

  • 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。讓我們從戴夫開始吧。

  • 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,很好的問題。當我們考慮長期營業利潤時,顯然,我們的目標是隨著時間的推移擴大營業利潤。顯然,我們期望至少回到新冠疫情前的水平,但有一點需要注意的是,隨著我們的前進,我們的產品組合中確實有不同的產品組合,特別是與新冠肺炎相關的疫苗。

  • 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,從營業利潤的角度來看,疫苗確實稀釋了該產品。因此,通過調整組合,您應該會看到我們隨著時間的推移回到了這些水平。但顯然,隨著我們進入 24 年,當我們整合 Seagen 時,我們將讓您更清楚地了解所有的看跌期權和收益,當我們從新冠特許經營權的角度向前推進時,它看起來如何,以及所有的發展我們現在已經推出了管道。

  • 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。邁克爾,mRNA,流感。

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

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

  • Yes. 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 方面的全部經驗讓我感到非常鼓舞,這將是一種新的模式,就像針對 COVID 一樣,但現在針對流感,它[通過機制]與我們應該渴望的 B 細胞和 T 細胞結合因為,它的療效比我們在舊流感中看到的要好。我們正在繼續這項研究,因為我們只是想有更多的事件,特別是添加流感 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,希望能夠在今年晚些時候完成這項研究。但我們也正在採取緩解措施,增加免疫研究,這些研究可以補充獲得針對甲型流感和乙型流感的活動的完整良好數據包。但正如我所說,我仍然非常樂觀地認為 mRNA 將成為下一個重要平台應對流感。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.

    如果可以的話,有兩個問題。在潛在的企業範圍成本計劃中,除了新冠肺炎計劃之外,您是否還有一些機會可以考慮?您能否幫助我們了解研發與銷售、一般管理費用或其中其他組成部分的相對權重?我之所以這麼問,部分原因是你們已經宣布了一些變化,例如,在腫瘤學和西雅圖遺傳學的預期下,研發高層管理結構發生了一些變化。

  • 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,在落基山工廠,聽到你們自己的員工的說法真是令人放心。但我認為人們希望了解損害的規模,以及獲得更多時間信息的潛在控制因素是什麼?我知道你們已經與一些醫院客戶進行了溝通,但是任何關於恢復的規模、影響和時間以及從進展的角度來看可能會是什麼樣子的額外見解都會有所幫助。

  • 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.

    讓我談談落基山,然後我會請戴夫回答有關成本調整計劃的問題,以防我們的收入因新冠疫情而大幅減少。落基山,颶風的損壞很嚴重,但損壞主要集中在倉庫,這意味著我們損失了大量即將發往市場的庫存。設施本身,生產設施沒有受到颶風的影響,所以建築物矗立在那裡。然而,由於公用事業中斷,這些設施不得不停止運營。在這種高度敏感的無菌環境中,當斷電時,打開和關閉並不容易。我們需要時間和很多流程才能啟動它。

  • 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.

    額外的挑戰將是一些也被銷毀的材料庫存,特別是玻璃和其他啟動材料,我們需要確保及時更換。所以我想說的是,我們非常有信心整個事情會重獲新生。但我們仍在評估這需要多長時間。我們正在盡一切努力確保最大限度地減少市場短缺的情況。現在讓我們來談談成本調整計劃的更多細節。

  • 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。謝謝你的提問。顯然,當我們在 23 年下半年開發這個計劃時,我們期待在進入 24 年時分享更多細節,並在您考慮我們的成本時為您提供很多里程碑。以及未來的投資結構。重要的是,如您所知,我們對即將在這裡進行的 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,這將使公司能夠重新集中精力和投資,以確保我們未來專注於抗擊癌症。我們認為,當我們將資源集中到該特許經營權和抗擊癌症的鬥爭中時,這是一個巨大的機會,這對患者來說是一個機會,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,我們將在今年下半年獲悉我們的收入表現,特別是與新冠病毒相關的收入表現。這將告訴我們在 24 世紀和 25 世紀及以後擴大利潤的機會水平。這將使我們能夠退後一步,確保我們所有的成本、所有投資都與 Seagen 的目標保持一致,並與我們的內嵌產品組合以及我們講話時正在發生的產品的性能最大化相一致。今年下半年。

  • 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.

    再次強調,我們期待就此分享更多內容。這將是平衡的,正如您在 SI&A 和 R&D 之間所熟知的那樣,我們將在今年晚些時候和明年為您提供具體的細分和具體信息。

  • Operator

    Operator

  • Next, we have Louise Chen with Cantor.

    接下來是 Louise Chen 和 Cantor。

  • 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?

    我想首先詢問您有關您認為可能在 23 年下半年出現的這些新冠肺炎情景的問題。您可以通過什麼方式分享您預計可能發生的一些重大事件?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 會出現任何潛在的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。關於新冠病毒,我會說幾句話,然後我會請安吉拉對這兩個問題發表評論。看,新冠肺炎的情況,這取決於情況。有哪些不確定因素?我想我已經表達清楚了。我們先從疫苗說起。最大的不確定性是疫苗接種率。我認為市場份額已經相當穩固。疫苗接種率是我們將在即將到來的秋季看到的情況。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.

    另一個不確定性是在美國商業化的時間,因為當然,你會面臨新的庫存、新的市場銷售以及更高的價格。這已經解決了。我們知道我們很可能會在 9 月份推出,因為 FDA 和 CDC 要求我們基本上通過創建新疫苗來改變庫存。所以這將會發生。

  • 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,新冠疫苗存在的另一個不確定性是歐洲合同。那是一份非常長、非常大的合同。現在我們已經確定它已經經過談判,今年的金額會少一些,因為它已經分散了 4 年,但已經重新談判了。所以所有這些都是關鍵的不確定性。當然,有多少拉美、拉丁美洲和其他國家更願意這樣做。這不是唯一的,但我們認為這些是基礎。

  • 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.

    我們將大致了解第三季度的趨勢。我們將非常準確地了解今年年底的情況,我認為這將是一個非常大的預測因素,可以預測未來的情況,如果我們有流感或流感聯合疫苗,唯一的好處是有了RSV,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.

    在 PAXLOVID 上,不確定性更多一些,因為當然,我們的治療率和感染率存在不確定性。我們不知道它會如何表現。我們沒有任何基準來了解情況如何。我們知道,治療率與感染率密切相關,而且感染率目前正在上升。但這將如何發揮作用還有待觀察。當然,與 PAXLOVID 的出現和進入市場一樣,當感染率上升時,每週都會發送腳本。

  • 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.

    但我們還有一些不確定性,那就是啟動的時間,這將取決於我們如何就公共衛生利益與各國政府就啟動過渡達成一致。所以這一切還有待觀察。這些是我們在新冠疫情中看到的情景。關鍵信息是不確定性將在今年年底消失。我們將知道新冠疫情將對輝瑞的收入做出穩定的貢獻,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,也許你想補充一下,然後談談下一個問題——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.

    Louise,我認為當您談論 VYNDAMAX 或 VYNDAQEL 時,我們非常有信心的最大和我們最大的差異化因素就是我們數據的整體性,實際上是沿著 4 個維度。無論是臨床數據還是現實世界的數據。我們有全因死亡率和與心血管相關的住院數據。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.

    我們還通過實際數據證明了 5 年時的顯著生存效益。因此,無論你從哪個角度來看,如果你將其與任何競爭對手的項目進行比較,我認為我們擁有一個高度差異化且極其有價值的分子,可以很好地對抗任何競爭對手。

  • Operator

    Operator

  • Next, we have Mohit Bansal with Wells Fargo.

    接下來是富國銀行的莫希特·班薩爾 (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?

    也許是這個的後續一點。順便說一句,感謝您提供的所有透明度。因此,可以公平地說,在您迄今為止看到的新冠疫情趨勢中,至少銷售趨勢低於您的預期,並且您希望在調整預期之前再看到 1 個季度。我問這個問題是因為如果我看一下——你似乎仍然預計美國下半年將有 8800 萬左右的疫苗接種,而根據我們的換算,這個數字實際上是 4400 萬左右管理方面,出貨量為 1.11 億。因此,我想了解一下,您所在的地方是不是我們可以在第三季度獲得更好的新冠病毒數據更新?

  • 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。感謝你的提問。我認為答案是肯定的,我們應該做得更好。這並不是說我們只想再看到一個季度。我們希望看到呼吸季節的大部分時間。我們總是說新冠病毒,我想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。這已經變得越來越清楚了,對嗎?

  • 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.

    這些疫苗接種大部分發生在今年第三和第四季度。所以這並不是說我們只是另一個季度。我們正在等待主要季度。如果新冠疫苗接種率接近流感疫苗接種率,那麼我們就已經達到了我們預期的水平。如果它們只是流感發生的一小部分,那麼我們當然會錯過。這就是為什麼我們要看看它會如何發展。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.

    其餘的,儘管上半年我們對總增長做出了重大貢獻。因此,如果我們能夠利用那裡的庫存來確保我們知道新冠肺炎專營權將變得有多大,我們就不需要那麼多庫存。正如我所說,在歐盟,我們已經調整得很好。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.

    我們有世界其他地方的庫存,但庫存也是去年的。因此,我們現在預計產品將開始走出去,或者(聽不清)產品將開始從更多國家重新訂購。這就是為什麼 PAXLOVID 的感染率將非常非常重要。而這一切現在正在發生。因此,一旦我們了解了它們,我們就可以更準確地進行預測。非常感謝。

  • Operator

    Operator

  • Next, we have Trung Huynh with Credit Suisse.

    接下來是瑞士信貸銀行的 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,您的非新冠業務的長期前景仍然完好無損。您如何看待 2025 年中期指南,因為如果您假設前 COVID '23 指南的中點為 7%,為了實現 2020 年至 2025 年前 COVID 指南的 6%,根據我們的計算,您需要做24 年和 25 年該基礎業務實現高個位數增長。這看起來很困難,尤其是因為你將擁有更多 LOE。那麼您對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 基本上來自 26 年,對吧?所以一直到25年,我認為影響不會那麼大。此外,我們給出的指導是 6%,如果我——是的,我們非常有信心我們會實現這一目標。所以我們會繼續下去,這些年來我們現在的增長率是 6%,對吧,今年迄今為止。所以,是的,我認為,對於非新冠疫情業務,產品發布的成功非常重要。所以我們會看到很多事情擺在我們面前。但它的可預測性要好得多。我認為我們已經做到了這一點,所以我認為不會有任何變化。順便說一下,謝謝你的提問。

  • Operator

    Operator

  • Next, we have Colin Bristow with UBS.

    接下來是瑞銀集團的科林·布里斯托 (Colin Bristow)。

  • 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.

    danuglipron 的另一個後續行動。我只是不知道我們什麼時候會聽到每日一次的配方。我只是想了解您對將其製成每日一次的配方而不會對 AE 曲線產生負面影響(大概是考慮到 Cmax 的增加)的信心程度。

  • 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?

    然後更廣泛地說,您能否更多地談論一下您將如何在這裡競爭,因為我認為之前提到過您在競爭、臨床差異、可能不太方便的劑量以及本質上是一個治療類別方面落後於競爭對手,其中你沒有重要的存在。然後也許是另一個關於 DMD 基因治療的管道項目的快速項目。這是一項後期資產,似乎沒有太多播放時間。您對這個計劃的熱情是否正在減弱?或者只是其他人更重要?

  • 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。因此,Mikael 再次強調,肥胖市場及其規模顯然引起了人們對 danuglipron 的極大興趣,所以問題是關於 1 天配方的。然後還告訴我們一些關於 DMD 的情況。

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

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

  • I 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感興趣,我想說,我認為我們在創建該產品時沒有任何特別的障礙。我們在緩釋製劑方面擁有豐富的經驗。正如我們不久前啟動的那樣,我們的早期數據告訴我們,當涉及每日一次的 danuglipron 改良釋放時,我們應該感到鼓舞,我相信在合理的未來我們手中將擁有這樣的製劑。

  • When could it come to the market if the drug continues and makes a great Phase III? 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出色的 III 期臨床試驗,那麼什麼時候可以上市?嗯,我認為我們可以在發佈時或發布後不久就發布它。所以我不會擔心這個。但我同意你的觀點,每天一次的改良釋放有時實際上可以通過(聽不清)以及變異性和暴露來改善耐受性,這通常會減少被視為限制這種藥物的胃腸道副作用。因此,我認為 MR 具有潛在的雙重優勢,從每天兩次改為每天一次,並且還可能有助於在口服 GLP 結構中創建耐受性概況。

  • (inaudible) 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.

    (聽不清)令我感到鼓舞的是,FDA 在談到該藥物進入市場的緊迫性時對該藥物採取了非常積極的態度。克里斯,你和我對此進行了密切合作,我們預計今天將很快結束審判。我也會請克里斯參與其中。

  • 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 計劃顯然對我們非常重要,不僅因為基因治療的重要性,而且對於患有這種絕對毀滅性疾病的患者和家庭。今年晚些時候,我們確實對 CIFFREO 試驗進行了中期分析。 CIFFREO試驗目前所有患者均已入組研究。中期分析將不是基於替代生物標誌物終點,而是基於真正的功能終點。因此,我們認為衡量基因治療對這種疾病的益處的最佳方法是功能終點。這應該會在今年晚些時候完成,我們將在 2024 年向您提供該研究的最終分析結果。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • 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,就像您聽到的那樣,Sarepta [註冊] 生物標誌物數據在我們手中看起來非常可靠。但正如克里斯所說,我們希望為患者提供更多有關潛在益處的經驗。

  • Operator

    Operator

  • Next, we have Kerry Holford with Berenberg.

    接下來是凱瑞·霍爾福德和貝倫貝格。

  • 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 III 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)。顯然,對新冠病毒資產的需求將影響您是否使用該設備。但考慮到您之前強調的新冠病毒聯合疫苗的潛力,我有興趣了解您的 mRNA 流感疫苗試驗即將進行的 III 期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,你們的抗 TFPI 表示你們將在今年下半年為非抑製劑患者提交申請。我們是否應該假設您明年才會尋求在該患者群體中推出?或者您會在進入市場之前等待抑製劑患者組的詳細信息嗎?也許你可以討論一下你在這種藥物中看到了多大的機會。

  • 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.

    讓我從新冠病毒開始,然後 Mikael 也可以發表評論。但例如,我們對這些組合感到非常興奮,對吧?這些組合將是流感和新冠病毒,然後是流感、新冠病毒和呼吸道合胞病毒。我們正在努力解決這個問題。事實上,我們相信,如果我們與非 mRNA 進行組合,我們可能會期望獲得更好的安全性,因為我們不必將 3 個產品的 RNA 加載到單次注射中,但我們將僅使用 2 種,即新冠肺炎和流感,然後我們將使用基於蛋白質的疫苗(聽不清)。所有這些都運作良好。

  • 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,如果新冠病毒市場被認為是非常單價的,將會發生什麼。這是非常非常低的。我認為這將在我們控製成本的決定中發揮作用,因為如果成本非常非常低,儘管我們預計這種組合會有好處,但我們會假設現階段對新冠病毒的醫療需求並不那麼高。因此,我們將減少在該領域的投資,並降低對銷售的預期。然後,如果組合出現並且我們更加成功,那麼我們就會恢復。你還想——你的第二個問題是什麼?是的,關於馬斯塔西單抗。米凱爾?

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

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

  • 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。我關注這個項目很長時間了。如您所知,我們報告了非常令人鼓舞的數據。與按需使用相比,我們的年出血率降低了 92%。我們確實沒有發生與其他產品(包括 Hemlibra)相關的安全事件。它對 A 和 B 都有活性。它通過預裝筆進行給藥。我認為,從醫學角度來看,它可以是一個非常大的產品,是血友病 A 和 B 的單一選擇。當然,當我想到 Hemlibra 如何為血紅素 A 患者帶來如此大的希望時,我看到了這個簡介看起來很不錯,我樂觀地認為它在這兩個領域都能做得很好。

  • 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。所以很感興趣。因此,讓我們嘗試更多——請提出一個問題。

  • Operator

    Operator

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

    我們的下一個問題將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.

    剛剛吃了兩個真正快的。 Angela,在 Prevnar 上,長期增長是什麼樣的?顯然,您可能面臨更激烈的競爭環境。如果你失去了份額,你認為 [TAM 增長] 會怎樣來抵消這一影響?然後 Mikael,您談到了下一代 CDK。我知道它還處於開發初期。但您是否存在風險收益障礙?我只是考慮 IBRANCE LOE 後的成本效益以及競爭格局。

  • 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?

    安吉拉,您對我們的競爭對手的競爭環境非常關心,但我們有一些您可能想討論的現實。而且,我還會問——實際上,將由 Chris Boshoff 來回答 CDK4 的問題,因為我們以新的身份邀請了他。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,我首先想說的是,我對整個 Prevnar 系列的表現感到非常自豪。如果你看一下成人的適應症,我們已經成長了——自去年以來,我們不僅增長了 23%,而且我們是在整個疫苗接種季節之前完成所有這些增長,這是你通常看到的。因此,我們能夠接種這些疫苗的事實告訴我們很多關於我們在肺炎球菌疾病方面所做的工作,它是多麼受到讚賞,而且我們的機器運轉得有多好,更不用說以下事實:我們擁有 96% 的成人適應症份額。

  • 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 peds 領域,我們從 100% 的市場份額發展到今天,與 PCV15 分享部分市場份額。但我只是想提醒大家,這是可以預料的,我們正是在我們想像的地方。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。我認為這裡要認識到的重要一點是,考慮到我們剛剛收到的 ACIP 對 Prevnar ped 的建議,我們現在開始看到的是這種下降趨勢的逆轉和市場份額的恢復。

  • 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.

    因此,我們看到一些帳戶現在購買 PCV20 ped,我們看到一些帳戶從 PCV15 切換到我們自己的 Prevnar 20,事實上我們的聯邦合同已將 Prevnar 20 添加到他們的登記冊中,這意味著公眾疫苗接種可以開始。然後,也許我要提到的一件事是,與任何其他肺炎球菌疫苗相比,Prevnar peds 是獨一無二的,那就是我們被建議接種成人疫苗——好吧,免疫功能低下的 2 至 18 歲兒童。所以這是我們以前從未有過的全新人口。

  • 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,當您將所有這些放在一起並考慮到僅在本季度,Prevnar 特許經營權就在第一季度創造了 13 億美元的收入,我認為這個數量級可以讓您了解我們投資組合的規模和競爭力,我們對 Prevnar 在接下來的幾個季度中可以做的事情感到非常興奮。

  • 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 PCV15 的競爭下進行的,如果我沒記錯的話,我認為該價格約為 1.5 億美元。 Chris,您能談談 CDK4 和那邊的特許經營權嗎?

  • 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.

    感謝你的提問。如您所知,ER+ 乳腺癌是全球女性最常見的癌症,我們非常自豪能夠通過 IBRANCE 鞏固我們在細胞週期抑制領域的領先地位。並擁有 3 種一流的潛在資產,CDK4 特異性抑製劑、CDK2 特異性抑製劑和 KAT6 特異性抑製劑,所有 3 種藥物都具有改變未來 ER+ 乳腺癌治療的巨大潛力。

  • 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,我們看到更完整和連續的 CDK4 靶標覆蓋,並且由於 CDK6 抑制減少而可能提高耐受性。正如 Mikael 所指出的,CDK6 會導致血液學脆弱性。我們知道上皮細胞特異性地高度表達 CDK4,這就是為什麼特異性靶向 CDK4 如此重要。正如 Mikael 指出的那樣,我們的 CDK4 抑製劑導致 3 級中性粒細胞減少症的比例為 15%,而其他 CDK4/6 抑製劑的預期比例為 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。再說一次,這與您所了解的其他一些 CDK4/6 抑製劑有很大不同。我們正在加速我們的註冊策略,在二線後 CDK4/6 的第一項研究中,我們最近在重度預處理人群中顯示出 30% 的總體緩解率,並且我們也開始使用 CDK4 加 CDK2 的人群作為 CDK4 與我們潛在的下一代骨幹 ARV-471 或 vepdegestrant,我們正在與 Arvinas 共同開發。

  • Operator

    Operator

  • Next, we have Tim Anderson with Wolfe Research.

    接下來是沃爾夫研究中心的蒂姆·安德森。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • 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?

    如果我能回到新冠疫情指導就好了。投資者不僅對 23 年之前的指導水平持謹慎態度,而且對 23 年後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,比如說未來的曲線。您是否仍然有信心說 2023 年應該是低谷,然後您將在 2024 年及以後反彈到更高的銷售水平,並從那時起看到持續增長?或者說現在也更加不確定了?

  • 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構成我們對未來幾年進行可靠預測的基礎。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,然後治療率和感染率也將在新的一年之後表明我們應該定期預期的情況。

  • 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,我們將不得不應對一些庫存變動,今年是過渡年,因為我們將給出價格,並且我們將吸收一些庫存等等。因此,這應該可以提供 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應該看到的數字。但前提是我們有合理的疫苗接種和 PAXLOVID 治療範圍。所以這就是為什麼我說讓我們拭目以待今年的實際情況。正如我所說,特別是利用率如何。因為明年,所有這些庫存和價格調整的事情將會非常清楚。非常感謝你提出這個問題。

  • Operator

    Operator

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

    我們的下一個問題將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.

    感謝您在新冠疫情方面的思維過程的透明度。今天早上問了很多很好的問題。我想我想知道的一個問題是您去年年底超出了 TL1A 的許可,但沒有得到解決。然後你的合作夥伴轉身以高得多的價格出售它。我想——阿爾伯特,說得有點挑釁,輝瑞的股東在這一事件過程中得到了很好的利益嗎?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 的認可。所以我認為這是非常重要的想法,尤其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的操作是什麼。現在我們去TL1A看看是什麼情況。阿米爾,我們是否盡我們所知為股東服務?

  • 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。我要說的是,我們對 TL1A Telavant 與 Roivant 的合作夥伴關係感到非常滿意。我們確實認為股東得到了很好的服務。提醒一下,我們為什麼要輸入這個。我們將此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 II program, we feel this is a very sound move for Pfizer shareholders.

    因此,我們時不時地會將決策作為我們合作夥伴研發計劃嚴格流程的一部分,我們認為最好與合作夥伴分擔風險或成本。在這種情況下,Telavant 承擔了未來的所有研發成本。這為輝瑞釋放了大量的研發能力,以投資於高優先級項目。但我們仍然通過 3 種不同的方式保留該計劃的價值。我們擁有 Telavant 25% 的股權,我們擁有全部(除美國以外)股權。以及日本以外的版權,我們還獲得了美國和日本銷售的特許權使用費。總而言之,這次合作使我們能夠以 0 增量研發支出保留 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。邁克爾,這裡有什麼要補充的嗎?

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

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

  • 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 (inaudible) 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擁有強大的雙特異性平台,包括免疫學,而且我們確實有 TL1A(聽不清)抗體。這將非常有趣,因為我們擁有更多的股份。我們有關於特應性皮炎的三重細節。所以這只是強調它。即使在同一個治療領域,我們也會發生很多事情。短期內,我們預計 etrasimod 很快就會獲得批准,並且還將繼續進行另一次讀數。有很多事情要從這裡開始。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

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

    謝謝。謝謝你,米凱爾。不要過多考慮我們口袋裡的東西的競爭。

  • Operator

    Operator

  • Next, we have Steve Scala with Cowen.

    接下來是史蒂夫·斯卡拉(Steve Scala)和考恩(Cowen)。

  • 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,但觀察結果是,與 6 個月前首次給出 300 億美元的指導時相比,目前還不清楚您對新冠病毒的長期預期發生了什麼變化,因為在過去 6 個月裡,沒有任何變化除了 FDA 的行動之外,確實發生了變化,這不會影響長期。所以這只是一個觀察。

  • 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 已成為非常重要的特許經營權,但其在美國或歐盟的獨占性並不長久。是否有任何策略可以繞過 LOE?或者它只是類似於 Eliquis,在 LOE 後,輝瑞將轉向其他產品?

  • 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。那麼你為什麼不回答這個問題呢,安吉拉?

  • 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,它是一款極​​其重要的產品,我們對此感到非常自豪,因為它本季度仍以 40% 左右的速度增長。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,但我們有專利期限延期,可以讓我們度過 2028 年 12 月。在歐盟,是 2026 年。在日本,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.

    所以實際上,我覺得我們仍然有一個良好的跑道,因為它與該產品有關,我們需要做更多的診斷,我們可以在 VYNDAQEL 上吸引更多的患者,特別是我們擁有令人難以置信的競爭力和差異化形象。正如你所說,我們一直在與阿米爾合作,尋找適合這個系列、這個組合的機會。但我想從我的角度來看,無論有沒有它,我們都看到了繼續實現增長的難以置信的強大機會。

  • 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?

    我的問題是關于輝瑞的 mRNA 候選流感疫苗。賽諾菲在最近的疫苗分析日上表示,鑑於針對 B 株的 mRNA 技術問題,第一代針對流感的 mRNA 無法提供足夠的 B 株功效。那麼您能否對此發表評論以及您對疫苗南半球株的期望今年晚些時候會有B 療效結果嗎?

  • 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 菌株,但我很好奇您對證明 B 菌株在南半球功效的期望。另外,您能否評論一下您對 mRNA 流感的預期反應原性概況與 COMIRNATY 的反應原性概況?

  • 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?

    非常感謝你,大衛。非常好的問題。 Mikael,那麼我們的——賽諾菲所面臨的技術問題,我們也遇到過嗎?

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

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

  • 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,我認為也許開創性的 mRNA 化合物是輝瑞(Pfizer),當然還有多年來致力於這項技術的 Moderna。我們花了 5 年時間,在整個 mRNA 鏈上做出了充分的改進。我認為這給我們帶來了很大的幫助,並為我們在新冠疫苗方面積累了世界經驗。所以我無法真正評論賽諾菲面臨的問題。我有一個更積極的看法——我對我們有能力設計能夠有效對抗甲型流感和乙型流感的 mRNA 疫苗抱有更加積極的看法。

  • 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.

    讓我們等等。讓我們積累數據並查看結果,但我對此持樂觀態度,並意識到這是一個需要大量具有中等反應原性的能力[供應商]的領域。流感的反應原性實際上是中等的,非常好。因此,在我們在年輕或老年患者中測試的劑量結束時,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,邁克爾。

  • Operator

    Operator

  • Next, we have Andrew Baum with Citi.

    接下來請來花旗銀行的安德魯·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取消對 PBM 的回扣,以抵消價格談判後 Eliquis 降價的影響,從而保護您的收入?或者,您是否認為即使 PBM 能夠以大幅降低的價格購買藥品,或者以大幅降低的價格為藥品提供資金,您仍然需要一次性支付這些費用?

  • 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,考慮到最近收購了 Seagen,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產品線,以便騰出空間或進一步優化您的研發花多少錢來支持 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,我們為什麼不首先回答一下 IRA 在改變回扣等方面意味著什麼,這是一個相當新的情況。所以我們必須看看它是如何發揮的。但如果你想談談這件事,安吉拉?

  • 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。所以說完全正確,艾伯特。我認為這是一項新政策,關於它的實施方式還有很多需要理解的地方。正如你所說,將會進行價格談判,但與此同時,我認為我們還必須記住,安德魯,有一個緩解因素,即更多的患者可能能夠使用 Eliquis,因為共同支付門檻和我們將根據 IRA 設定的上限。

  • 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。我們需要考慮很多事情,因為它涉及定價、回扣以及患者對藥物的使用,所有這些都會發揮作用。我想,因為它也特別與 Eliquis 有關,只是為了提醒大家,雖然它顯然是我們最大的藥物之一,但它的 LOE 將在 26 年的時間範圍內。因此,無論影響是什麼,都不會持久地影響我們的產品組合,因為無論如何它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.

    非常感謝你,安吉拉。這是一個不斷變化的環境,所以我們需要真正去看看它。另外,安德魯,很快就管道問題進行了討論。我們已經說得很清楚了,但收購 Seagen 對管道資產沒有任何意義。因此,管道資產不會因合併而被消除、減少或增加——實際上會因合併而增加,但管道資產不會因此次收購而減少。

  • 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?

    只是 COMIRNATY 上的兩人。您能否幫我一點忙——我想隨著更新的疫苗於 9 月份商業化,我們應該在第三季度和第四季度考慮多少剩餘的新冠收入?我只是想了解一下我們何時獲得第三季度的更新,這會基於我們在該季度看到的銷售額嗎?或者您對我們所看到的疫苗接種趨勢的更多解釋?所以只是設定期望。第二部分是關於歐盟合同重新談判。我想,您可以提供任何其他顏色來說明 2023 年的條款最終與 2023 年指南中反映的條款有何不同嗎?

  • 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。我很快就能接受。你看,如果你看到的話,第三季度我們基本上會有七月、八月、九月。因此,新的疫苗接種將在九月開始,當然,這是有希望的。我們預計將在八月底獲得批准。我們現在已經準備好了產品。所以我們已經——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.

    所以通常情況下,我們也應該在第三季度進行,大部分在第四季度進行。但是,真正能讓我們在第三季度末以及第三季度之後的一個月直到我們給出的結果——我們展示第三季度的結果——真正能讓我們澄清的是,這實際上是疫苗接種率,對嗎?這就是我們將要傳達的信息。然後是價格,對嗎?因為畢竟一切都以價格為基礎更好。因此,COMIRNATY 的這種不確定性很大一部分將會消失。

  • 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.

    關於歐盟合同重新談判,我不知道你是否注意到,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同和我們的假設,我們假設我們將在三年多的時間裡做到這一點。現在我們已經做了四年多了,這給我們的指導帶來了壓力,但後來我們簽訂了一些合同,我們沒有預料到拉丁美洲的指導,特別是,這抵消了其中很大一部分。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方針的理由。事實上,正如我所說,疫苗接種率將決定這種疫苗在未來幾年的潛力。非常感謝你,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?

    只給我一個。你正在進行大量收購。 Seagen,你最近做了一件大事。它尚未完成,但當我們展望未來時,您如何看待您在執行、商業方面以及科學方面看到的集成挑戰是什麼?哪些事情讓您感到興奮而不是擔心?

  • 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,對嗎?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.

    但在此之前您也進行過多次收購。所以,你已經進行了某種程度的多重集成,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。那麼,讓我從 Seagen 讓我們興奮的地方開始,我認為這是這家公司背後的科學。 ADC 目前在我們的研究和抗癌鬥爭中發揮著越來越重要的作用。 Seagen 擁有 2 個領先平台中的一個,我們相信它實際上是一個更好的平台。所以我認為這讓我很興奮。

  • 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.

    另外,令我非常興奮的是,與我們所提供的成果相比,Seagen 能夠以有限的成果實現所有這些偉大的成就。當然,我們在結果方面帶來的不僅是資本,還有設計分子的重要專業知識。特別是在小分子方面,我們非常非常非常好。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,我們認為有一種很好的方法可以將 Seagen 的這些產品商業化,但已經進入市場或將會出現,因為當我們審視全球業務時,Seagen 已經落後了。同樣在美國,一旦整個事情整合起來,我們的資源將幾乎增加兩倍。所以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.

    現在,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和整合。不僅是我們——我們過去確實也犯過一些錯誤的事情,也犯過一些正確的事情。所以我知道,非常非常重要的是,首先要確保在我們組建這兩個組織時不會發生文化衝突。為此,我們非常非常幸運,因為腫瘤公司往往擁有非常非常相似(聽不清)的腫瘤公司。

  • 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,即使是我們科學家的化學反應也與 Seagen 的科學家相比。事實上,真正明顯的是,在我們前進的過程中,Seagen 有多少偉大的科學家舉手加入克里斯的領導團隊。這些科學家將發布來自 Seagen 的信息。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,不僅是輝瑞公司,而且他們將領導全球——不僅是Seagen,而是全球,即Seagen plus core。

  • 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.

    我們需要非常小心的第二件事是,我們不要放慢速度,也不要增加成本。這是我們在大公司收購小公司時看到的情況。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,我們正在做大量的預整合規劃,以確保在將兩者結合在一起後,創新將得到顯著增強。當然,我完全信任克里斯,他正在領導這次整合,幾個月來一直在進行這項計劃。

  • 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,如果首席執行官(能夠解決公司衝突并快速做出決策的人)對正在發生的事情有很高的了解,那就太好了。所以我想得很快。這是我們幾十年來最大的投資。這顯然是我管理下最大的投資。

  • 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,將其視為最有潛力、令人興奮的成長機會之一。但我們也非常清楚,我們應該確保不會出現任何問題。所以我個人對此持贊同態度。正如您所看到的,Seagen 將成為我們未來最大的賭注之一。因此,我們正在利用我們所有的經驗和最優秀的人才,我非常非常高興。我非常非常高興,因為兩支球隊的化學反應現在是無與倫比的。他們就像一個人一樣工作,他們都將看到新的 Seagen/輝瑞腫瘤產品組合比我們單獨時增長得更快。

  • Operator

    Operator

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

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

  • Michelle Rivera

    Michelle Rivera

  • 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基因治療項目進展如何?您最終確定了患者的給藥劑量嗎?我在最近的一次會議上讀到一份聲明,稱您已完成對患者的篩查。所以我不確定這是否意味著審判已暫停。只要澄清一下這一點以及我們何時應該期待數據,就會有所幫助。

  • 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?

    Chris,您直到最近才開始運行 DMD。現在,你當然給了米凱爾這個責任。您能否快速向我們介紹一下 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。正如我之前提到的,臨床試驗現已完成入組。正如您所指出的,由於方案修訂,最後幾位患者的給藥暫停,但我們非常有信心我們將在今年晚些時候繼續進行基於功能終點的中期分析,該終點將被取代是的,也或者將與生物標記數據一起。我們將在今年晚些時候獲得功能數據和生物標誌物數據,然後在 2024 年進行全面研究的最終分析。我們現在還完全招募了早期年齡組,即 2 至 3 歲的患者,10 名患者參加了該試驗。所以,是的,我們期待在今年晚些時候為您分享數據。

  • 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。總之,我認為我們有一個穩定的季度,繼續投資,以支持我們在 18 個月內前所未有的 19 項潛在發布。這些都做得很好。該計劃按照時間表執行。在我們的管道中以及像 Seagen 這樣創造價值、創收的業務發展機會中,正如我在之前的問題中所闡述的那樣,這顯然是我們的大賭注,也是我們前進的非常非常大的機會。

  • 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 3 個月中,我們期待擺脫當前與 COVID-19 相關收入相關的不確定性。所以我們有更好的清晰度。到今年年底,我們將幾乎最終消除不確定性。如果需要對 24 世紀及以後的成本基礎進行任何調整,我們已做好準備。我想再次強調,從長期來看,最大的不確定性是疫苗接種率。一些短期的不確定性,比如什麼時候商業化,我認為這只是時間問題。但我認為,我們將看到的疫苗接種率和治療率將告訴我們對未來幾年的預期,而聯合疫苗只有好處。

  • 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.

    綜合所有這些因素,我們仍然相信我們有能力在本世紀末及以後實現強勁的運營增長並提供有意義的股東價值。

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

    至此,我們的通話就結束了。感謝您加入我們,祝您度過愉快的一天。

  • 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 年第二季度收益電話會議到此結束。我們感謝您的參與,您可以隨時斷開連接。