輝瑞首席投資者關係官歡迎與會者參加 2024 年第一季的財報電話會議,強調該公司今年開局良好,並專注於非新冠產品、腫瘤學領導地位和管道進展。
執行長討論了新冠疫情後的收入下降,但強調了營運成長和成本管理。該公司提高了今年的獲利指引,並繼續專注於財務承諾和股東價值。
討論涵蓋各種主題,包括產品績效、財務預測、資本配置和2025 年潛在市場影響。股東價值最大化。
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 First Quarter 2024 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Francesca DeMartino, Chief Investor Relations Officer and Senior Vice President. Please go ahead, ma'am.
大家好,歡迎參加輝瑞 2024 年第一季財報電話會議。今天的通話正在錄音。現在,我想將電話轉給首席投資者關係長兼高級副總裁 Francesca DeMartino。請繼續,女士。
Francesca M. DeMartino - Chief IR Officer
Francesca M. DeMartino - Chief IR Officer
Good morning, and welcome to Pfizer's earnings call. I'm Francesca DeMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us. This call is being made available via audio webcast at pfizer.com. Earlier this morning, we released our results for the first quarter of 2024 via a press release that is available on our website at pfizer.com.
早安,歡迎參加輝瑞的財報電話會議。我是首席投資者關係官 Francesca DeMartino。我代表輝瑞團隊感謝您的加入。此次通話將透過 pfizer.com 上的音訊網路廣播進行。今天早些時候,我們透過新聞稿發布了 2024 年第一季的業績,您可以在我們的網站 pfizer.com 上查閱。
I'm joined today by Dr. Albert Bourla, our Chairman and CEO; and Dave Denton, our CFO. Albert and Dave have some prepared remarks, and we will then open the call for questions. Joining for the Q&A session, we also have Dr. Chris Boshoff, EVP and Chief Oncology Officer; Alexandre de Germay, EVP and Chief International Commercial Officer; Dr. Mikael Dolsten, Chief Scientific Officer and President of R&D; Doug Lankler, EVP and General Counsel; and Aamir Malik, EVP and Chief U.S. Commercial Officer.
今天與我一起出席的還有我們的董事長兼執行長 Albert Bourla 博士;以及我們的財務長 Dave Denton。阿爾伯特和戴夫已經準備好了一些發言,然後我們將開始提問。參加問答環節的還有執行副總裁兼首席腫瘤官 Chris Boshoff 博士; Alexandre de Germay,執行副總裁兼首席國際商務官;首席科學官兼研發總裁 Mikael Dolsten 博士; Doug Lankler,執行副總裁兼總法律顧問;以及執行副總裁兼美國首席商務官 Aamir Malik。
Before we get started, I want to remind you that we will be making forward-looking statements and discussing certain non-GAAP financial measures. I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning and our disclosures in our SEC filings, which are all available on the IR website on pfizer.com. Forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements.
在我們開始之前,我想提醒您,我們將做出前瞻性陳述並討論某些非 GAAP 財務指標。我鼓勵您閱讀我們幻燈片演示中的免責聲明、我們今天早上發布的新聞稿以及我們在美國證券交易委員會 (SEC) 文件中的披露信息,這些都可以在 IR 網站 pfizer.com 上找到。電話會議中的前瞻性陳述受重大風險和不確定性的影響,僅代表電話會議最初日期的觀點,我們不承擔更新或修改任何陳述的義務。
With that, I will turn the call over to Albert.
說完這些,我將把電話轉給阿爾伯特。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Francesca. Good morning, everyone. Thank you for joining our call. In the first quarter, we had a solid start to the year, and we are cautiously optimistic about what we will achieve in 2024. I'm pleased and appreciate how our Pfizer colleagues are executing with discipline as they focus on the patients and others we serve. This helped us deliver a strong performance during the quarter in our non-COVID product portfolio, drive progress towards our oncology leadership, advance our pipeline and continue to strengthen our business.
謝謝你,弗朗西斯卡。大家早安。感謝您加入我們的電話會議。在第一季度,我們今年有一個良好的開端,我們對 2024 年的成績持謹慎樂觀的態度。我很高興並欣賞我們的輝瑞同事們在專注於病人和我們服務的其他人員的同時,嚴守紀律。這幫助我們在本季在非 COVID 產品組合中取得了強勁的業績,推動了我們在腫瘤學領域的領導地位,推進了我們的產品線並繼續加強我們的業務。
Today, we will discuss highlights from the quarter and provide updates about how we are continuing to make progress with the 5 strategic priorities we served with you at the start of the year. We are proud of the positive impact we achieved around the world with our deep capabilities and global scale. Through the first 3 months of the year, we reached more than 119 million patients with our medicines and vaccines. We will continue to build on Pfizer's 175-year history of driving medical and pharmaceutical breakthroughs as we maximize the opportunities in front of us.
今天,我們將討論本季的亮點,並提供有關我們如何繼續推進年初與您一起提出的 5 項策略重點的最新情況。我們憑藉著雄厚的能力和全球規模在世界各地取得的正面影響讓我們感到自豪。今年前三個月,我們的藥品和疫苗惠及超過 1.19 億名患者。我們將繼續秉承輝瑞 175 年推動醫療和製藥突破的歷史,最大限度地抓住眼前的機會。
Our confidence in the year ahead comes from our focus on executing the strategic priorities that we believe will deliver operational, commercial and financial success across our business. The priorities are: achieve world-class oncology leadership, deliver the next wave of pipeline innovation, maximize performance of our new products, expand margins by realigning our cost base and allocate capital to enhance shareholder value. In the first quarter, we made notable progress with each one, and I will share some highlights.
我們對未來一年的信心來自於我們專注於執行策略重點,我們相信這些策略重點將為我們的業務帶來營運、商業和財務上的成功。我們的優先事項包括:取得世界一流的腫瘤學領導地位、實現下一波產品線創新、最大限度地提高新產品的性能、透過重新調整成本基礎來擴大利潤率並分配資本以提高股東價值。在第一季度,我們各個方面都取得了顯著進展,我將分享一些亮點。
Many of you joined us in our Oncology Innovation Day in February, and I hope you found it to be a valuable opportunity to see how we are well positioned to achieve world-class oncology leadership. We are pleased with the excellence we have been able to achieve in both integration and commercial execution.
你們中的許多人都參加了我們二月份的腫瘤學創新日活動,我希望你們發現這是一個寶貴的機會,讓你們了解我們如何能夠實現世界一流的腫瘤學領導地位。我們對在整合和商業執行方面所取得的卓越成就感到非常高興。
With a strong mix of Pfizer and Seagen colleagues in the newly combined team, we believe we have one of the most experienced and talented groups of oncology leaders in the industry. We''re also already seeing the benefit of strong commercial execution with our newly cross-trained sales and field medical teams.
新團隊由輝瑞和 Seagen 的同事組成,實力強大。我們相信,我們擁有業內最有經驗和才華的腫瘤學領導團隊之一。我們也已經看到了我們新交叉培訓的銷售和現場醫療團隊強大的商業執行力帶來的好處。
In the first quarter of 2024, our oncology revenues grew 19% operationally over the same quarter a year ago, driven in part by: the acquisition of the 4 in-line products from legacy Seagenâ, âand then particularly, the strong ongoing launch of PADCEV in front-line locally advanced/metastatic urothelial cancer, regardless of cisplatin eligibility, following FDA approval based on the groundbreaking EV-302 data.
2024 年第一季度,我們的腫瘤學收入較去年同期增長了 19%,部分原因在於:從傳統 Seagen 收購了 4 種在線產品,尤其是基於突破性的 EV-302 數據獲得 FDA 批准後,PADCEV 在一線局部晚期/轉移性尿路上皮癌中的強勢持續推出,無論是否適合使用順鉑。
We have an increased demand for XTANDI, which continues to be a backbone therapy across the prostate cancer treatment continuum. And we have continued growth from LORBRENA, which could emerge as the potential first-line standard of care in ALK-positive metastatic non-small-cell lung cancer.
我們對 XTANDI 的需求不斷增加,它將繼續成為整個前列腺癌治療過程中的支柱療法。我們的 LORBRENA 業務持續成長,它可能成為 ALK 陽性轉移性非小細胞肺癌的潛在第一線標準治療方法。
Earlier this week, we also announced the full FDA approval of TIVDAK to treat recurring or metastatic cervical cancer. TIVDAK is the first antibody-drug conjugate to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer.
本週早些時候,我們也宣布 FDA 全面批准 TIVDAK 用於治療復發或轉移性子宮頸癌。 TIVDAK 是第一個對接受過治療的複發性或轉移性子宮頸癌患者俱有積極總體生存數據的抗體-藥物偶聯物。
Going forward, we are guided by a strategy focusing on our greatest opportunities to make a difference for patients with cancer. With the power of our deep expertise, broad and diverse portfolio and global scale, we are confident we are well on our way toward our 2030 goals of doubling the number of patients treated with our innovative cancer medicines; increasing the number of blockbuster medicines in our portfolio from 5 today to 8 or more; and driving an anticipated tenfold increase in the proportion of revenue from biologics.
展望未來,我們將遵循一項策略,專注於抓住最大的機會為癌症患者帶來改變。憑藉我們深厚的專業知識、廣泛而多樣化的產品組合和全球規模,我們相信我們正在順利實現 2030 年的目標,即使使用我們的創新癌症藥物治療的患者數量增加一倍;將我們產品組合中的重磅藥物數量從目前的5種增加到8種或更多;並推動生物製劑收入比例預計增加十倍。
This is important because it brings the potential to provide more durable revenue based on several factors, including Inflation Reduction Act considerations and the greater challenges of copying complex biologics. We will look forward to sharing continued updates with you on our progress in accelerating oncology breakthroughs.
這很重要,因為它有可能根據多種因素提供更持久的收入,包括《通貨膨脹削減法案》的考慮以及複製複雜生物製劑的更大挑戰。我們期待與您分享我們在加速腫瘤學突破方面取得的持續進展。
Now I''ll turn to our progress with delivering the next wave of pipeline innovation. In Oncology, during the quarter, we had three pivotal Phase 3 study starts, including the first Phase 3 trial for our selective CDK4 inhibitor, atirmociclib; our integrin-beta-6-directed ADC, sigvotatug vedotinâ; and the fourth Phase 3 trial for ELREXFIO in multiple myeloma.
現在我將談談我們在實現下一波管道創新方面所取得的進展。在腫瘤學方面,本季我們啟動了三項關鍵的 3 期研究,包括選擇性 CDK4 抑制劑 atirmociclib 的首個 3 期試驗;我們的整合素β6導向 ADC,sigvotatug vedotinâ;以及 ELREXFIO 治療多發性骨髓瘤的第四階段 3 期試驗。
At the upcoming American Society of Clinical Oncology Annual Meeting, we will present data spanning each of our tumor areas of focus and core scientific modalities, including new 5-year progression-free survival data for LORBRENA, Phase 3 data for ADCETRIS in diffuse large B cell lymphoma and additional developments from across our deep and diverse pipelines.
在即將舉行的美國臨床腫瘤學會年會上,我們將展示涵蓋我們每個腫瘤重點領域和核心科學模式的數據,包括 LORBRENA 的新 5 年無進展生存期數據、ADCETRIS 在瀰漫大 B 細胞淋巴瘤中的 3 期數據,以及來自我們深度和多樣化管道的其他進展。
We are also driving continued execution beyond Oncology, with a sharpened focus on key value drivers expected to build potential multi-billion-dollar product portfolios. Through the first quarter, we are on track with delivering on our anticipated milestones and have important updates in both our growing Respiratory and Hematology portfolios.
我們也正在推動腫瘤學以外的持續發展,更加重視有望建構潛在價值數十億美元的產品組合的關鍵價值驅動因素。在第一季度,我們有望實現預期的里程碑,並在不斷增長的呼吸和血液學產品組合中取得重要更新。
With ABRYSVO, we believe we have the opportunity to further expand what is currently the broadest approved range of patients for the RSV vaccine, including adults 60 years and older and infants from birth to 6 months via maternal immunization. We recently reported positive results from the Phase 3 MONeT trial, evaluating ABRYSVO in adults aged 18 to 59 at increased risk for RSV disease.
有了 ABRYSVO,我們相信有機會進一步擴大目前最廣泛的 RSV 疫苗獲批患者範圍,包括 60 歲及以上的成年人和透過母體免疫接種的從出生到 6 個月的嬰兒。我們最近報告了第 3 階段 MONeT 試驗的正面結果,該試驗對 18 至 59 歲患 RSV 疾病風險較高的成年人使用 ABRYSVO 進行了評估。
The trial met its primary endpoints, and we intend to submit these data to regulatory agencies. We believe ABRYSVO has the potential to become the first and only RSV vaccine for adults 18 years and older.
該試驗達到了其主要終點,我們打算將這些數據提交給監管機構。我們相信 ABRYSVO 有潛力成為第一個也是唯一一個針對 18 歲及以上成年人的 RSV 疫苗。
Hematology is another priority area. With the progress of recent and near-term milestones, we are confident that we could establish a potential multi-billion-dollar product portfolio across hemophilia and sickle cell disease. We recently received the first U.S. FDA gene therapy approval for Pfizer with FDA approval for BEQVEZ, a one-time gene therapy for adults with hemophilia B.
血液學是另一個優先領域。隨著近期和近期里程碑的進展,我們有信心可以在血友病和鐮狀細胞病領域建立潛在的價值數十億美元的產品組合。我們最近獲得了美國 FDA 為輝瑞公司頒發的首個基因療法批准,即 FDA 批准的針對成人血友病 B 患者的一次性基因療法 BEQVEZ。
This program builds upon our growing presence in hemophilia. We expect an FDA decision before year end for marstacimab, which has the potential to become the first once-weekly subcutaneous treatment for the hemophilia B market, and the first treatment delivered as a flat dose for both hemophilia A and hemophilia B.
該計劃建立在我們在血友病領域不斷增長的影響力之上。我們預計 FDA 將在年底前對 marstacimab 做出決定,該藥物有可能成為血友病 B 市場首個每週一次的皮下治療藥物,以及首個針對血友病 A 和血友病 B 的固定劑量治療藥物。
Moving to sickle cell. We recently started the Phase 3 study of osivelotor, our potentially best-in-class next-generation hemoglobin S polymerization inhibitor. We are committed to addressing the underserved needs of the sickle cell disease community, and we are leveraging our capabilities for potential breakthroughs for these patients.
轉向鐮狀細胞。我們最近開始了對奧西韋洛托(osivelotor)的 3 期研究,奧西韋洛托可能是我們同類產品中最好的下一代血紅蛋白 S 聚合抑制劑。我們致力於滿足鐮狀細胞疾病患者群體的未充分滿足的需求,並正在利用我們的能力為這些患者帶來潛在的突破。
Now, I'll turn to our strategic priority of maximizing performance of our new products. While it may take a year to realize the full benefit of the changes we put in place, as we speak, to bring a more efficient structure to our commercial operations, we are pleased by the impact we are already seeing from our sharpened focus and Pfizer colleagues embracing our high-performance culture.
現在,我將談談我們的策略重點,即最大限度地提高新產品的效能。雖然我們可能需要一年的時間才能充分實現我們所實施的變革的效益,但正如我們所說,這些變革將為我們的商業運營帶來更有效率的結構,我們很高興看到,從我們更加專注和輝瑞同事擁抱我們的高績效文化中已經看到了影響。
Earlier, I mentioned the momentum of our Oncology products. Our Pfizer U.S. Commercial and Pfizer International Commercial organizations are also moving ahead in driving progress with growth in their respective markets. We have several potential key growth drivers for this year and into year 2025.
之前,我提到了我們的腫瘤產品的發展勢頭。我們的輝瑞美國商業和輝瑞國際商業組織也不斷前進,推動各自市場的成長。今年和 2025 年我們有幾個潛在的關鍵成長動力。
With ABRYSVO, we are very pleased with the positive data in the 18 to 59 age group that differentiates our product, and we are encouraged by our opportunities to continue increasing overall RSV market growth and market share.
我們對 ABRYSVO 在 18 至 59 歲年齡組中取得的積極數據感到非常滿意,這使我們的產品與眾不同,並且我們對繼續增加整體 RSV 市場增長和市場份額的機會感到鼓舞。
Another example of -- is our enthusiasm for the potential of NURTEC to help the more than one billion people living with migraine worldwide. With oral CGRP penetration leaving room for potential significant growth, we will continue to
另一個例子是我們對 NURTEC 幫助全球十多億偏頭痛患者的潛力充滿熱情。由於口服 CGRP 滲透率仍有大幅成長空間,我們將繼續
Focus on reducing access barriers for health care professionals and patients, as well as on education through direct-to-consumer marketing.
重點在於減少醫療保健專業人員和患者的獲取障礙,以及透過直接面向消費者的行銷進行教育。
With OXBRYTA, we will continue to educate health care professionals and patients on the importance of proactively treating the underlying cause of sickle cell disease by reframing treatment goals to chronic and proactive treatment. VELSIPITY is coming off its initial launch, and we are focused on ensuring patient access as a first-line advanced therapy oral option for moderate to severe ulcerative colitis.
透過 OXBRYTA,我們將繼續教育醫療保健專業人員和患者,透過將治療目標重新定義為慢性和主動治療,積極治療鐮狀細胞疾病的根本原因的重要性。 VELSIPITY 即將首次上市,我們致力於確保患者能夠獲得該藥物作為中度至重度潰瘍性結腸炎的一線先進治療口服藥物。
And I will mention LITFULO. We will work toward continuing to accelerate the consideration of advanced systemic treatments for appropriate patients with alopecia areata and further unlock access to LITFULO. Additionally, we continue to protect and grow our core brands and key blockbusters, including PREVNAR, VYNDAQEL and ELIQUIS.
我還要提到 LITFULO。我們將繼續致力於加快為適合的斑禿患者考慮先進的全身治療,並進一步解鎖使用 LITFULO 的管道。此外,我們繼續保護和發展我們的核心品牌和主要暢銷產品,包括PREVNAR、VYNDAQEL 和 ELIQUIS。
In a moment, Dave will provide updates about how we're also making progress with two other strategic priorities, expanding margins by realigning our cost base and allocating capital to enhance shareholder value. When we consider what we achieved in the first quarter, along with our continued progress in executing our 5 strategic priorities, we are cautiously optimistic about the year ahead.
稍後,戴夫將介紹我們在其他兩個策略重點方面的進展,即透過重新調整成本基礎來擴大利潤率,以及分配資本來提高股東價值。當我們考慮到我們在第一季的成就,以及我們在執行五大戰略重點方面取得的持續進展時,我們對未來一年持謹慎樂觀的態度。
We are continuing to focus on commercial execution, protecting and growing our products and driving strong starts with new commercial launches. With the progress we are making in advancing our cost-realignment program, as well as our confidence in the underlying strength in our business and our continued execution, we have raised our outlook for 2024 adjusted earnings per share by $0.10.
我們將繼續專注於商業執行,保護和發展我們的產品,並透過新的商業發布推動強勁開局。隨著我們在推進成本調整計劃方面取得的進展,以及我們對業務潛在實力和持續執行的信心,我們將 2024 年調整後每股收益預期上調了 0.10 美元。
We have confidence in our company. With some of the most experienced and talented colleagues in the industry, we have demonstrated many times before that we are very good at execution, and we expect to continue delivering life-changing medicines for hundreds of millions of patients globally and meaningful value for our shareholders.
我們對我們的公司有信心。我們擁有業內一些最有經驗和才華的同事,之前已經多次證明我們非常擅長執行,我們希望繼續為全球數億患者提供改變生活的藥物,並為我們的股東帶來有意義的價值。
Now, I will turn it over to Dave to discuss the financial performance during the quarter as well as our progress in strengthening our business and enhancing shareholder value. Dave?
現在,我將讓戴夫討論本季的財務表現以及我們在加強業務和提高股東價值方面的進展。戴夫?
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Thank you, Albert, and good morning. As we continue to navigate a challenging post-COVID environment, I''m pleased to share that this year is off to a solid start. We are protecting and growing our core brands while investing in building a more effective organization. Our relentless focus on execution is positioning Pfizer to improve shareholder returns.
謝謝你,阿爾伯特,早安。隨著我們繼續應對充滿挑戰的後疫情環境,我很高興地告訴大家,今年我們已經有一個好的開始。我們在投資建立更有效的組織的同時,也在保護和發展我們的核心品牌。我們堅持不懈地註重執行,以幫助輝瑞提高股東回報。
This morning, I'll briefly review the highlights of our first quarter results, then I'll touch on our capital allocation priorities. I'll wrap up by outlining our 2024 financial guidance as well as our key priorities for the remainder of this year.
今天上午,我將簡要回顧我們第一季的業績亮點,然後談談我們的資本配置重點。最後,我將概述我們 2024 年的財務指導以及今年剩餘時間的主要優先事項。
Turning to the first quarter, let me walk down the P&L. Total company revenues for the quarter were $14.9 billion, reflecting an operational decline of $3.5 billion or 19% versus last year. As you know, our business continues to be negatively impacted by a declining COVID environment on a global basis. To that end, we expect our COVID products will continue to have an outsized effect on both our top line and our bottom line throughout this year.
談到第一季度,讓我來介紹一下損益表。本季公司總營收為 149 億美元,與去年相比營業收入下降 35 億美元,降幅為 19%。如您所知,我們的業務持續受到全球新冠疫情環境惡化的負面影響。為此,我們預計我們的 COVID 產品將在今年繼續對我們的營收和淨利潤產生巨大影響。
However, I do want to point out that we expect our COVID products will continue to be contributors to revenues and cash flows for the foreseeable future. Strong commercial execution across the enterprise drove 11% operational revenue growth in the quarter when you exclude COMIRNATY and PAXLOVID.
不過,我想指出的是,我們預計我們的 COVID 產品將在可預見的未來繼續成為收入和現金流的貢獻者。如果排除 COMIRNATY 和 PAXLOVID,整個企業強勁的商業執行力推動本季營運收入成長 11%。
Performance was positively impacted by our renewed focus on key products and markets, refined allocation of commercial field resources globally and further alignment of marketing resources into key priority areas. Contributing to this performance were our acquired products from Seagen, alongside in-line products such as VYNDAQEL, ELIQUIS and ABRYSVO.
我們重新專注於重點產品和市場、優化全球商業領域資源分配以及進一步將行銷資源分配到關鍵優先領域,這些都對業績產生了積極影響。我們從 Seagen 收購的產品以及 VYNDAQEL、ELIQUIS 和 ABRYSVO 等線上產品為此業績做出了貢獻。
Dampening our growth in the quarter was the expected lower global demand for IBRANCE and SULPERAZON, driven largely by lower demand in China in the first quarter of 2024 versus last year.
本季我們成長的原因是預期全球對 IBRANCE 和 SULPERAZON 的需求下降,主要是因為 2024 年第一季中國的需求與去年相比下降。
Adjusted Gross Margin for the first quarter improved by 530 basis points to 79.6% versus Q1 of last year. This improvement was driven by 3 factors. First were lower sales volume of COMIRNATY resulting in favorable sales mix. Second, in the quarter, we recorded a product return adjustment for PAXLOVID associated with our U.S. government contract, and I'll touch upon that in just a moment.
第一季調整後毛利率較去年同期增加 530 個基點,至 79.6%。這項改善由三個因素推動。首先是COMIRNATY的銷售量較低,導致銷售組合有利。其次,本季度,我們記錄了與美國政府合約相關的 PAXLOVID 產品退貨調整,稍後我將談到這一點。
And finally, we executed strong cost management across our manufacturing network. Improvements in our gross margin rate will continue to be an important focus for the company going forward. Total Adjusted operating expenses increased modestly by 1% to $5.9 billion compared to Q1 of last year despite adding expenses associated with the acquired Seagen business.
最後,我們在整個製造網絡實施了強有力的成本管理。提高毛利率將繼續成為公司未來發展的重點。儘管增加了與收購 Seagen 業務相關的費用,但總調整後營業費用與去年第一季相比小幅增加了 1%,至 59 億美元。
This disciplined cost control puts us squarely on track to delivering on our $4 billion net savings commitment by the end of the year. Adjusted SI&A expenses increased 3% operationally in the quarter, driven by an increase in marketing and promotional expenses for recently acquired or launched products, partially offset by a decrease in expenses for PAXLOVID and COMIRNATY.
這種嚴格的成本控制使我們預計在年底前實現 40 億美元的淨節約承諾。調整後的 SI&A 費用在本季度營運中增加了 3%,這主要由於最近收購或推出的產品的營銷和促銷費用增加,但 PAXLOVID 和 COMIRNATY 費用的減少部分抵消了這一影響。
Consistent with our strategy, we are prioritizing our R&D spending to enhance overall returns while supporting growth from our pipeline. For the quarter, adjusted R&D Expenses were $2.5 billion, a decrease of 1% operationally versus LY. The slight decline was driven primarily by a lower spending resulting from our cost realignment program and lower spending on certain vaccines program, largely offset by increased investments mainly to develop certain assets acquired from Seagen.
根據我們的策略,我們優先考慮研發支出,以提高整體回報,同時支持我們的產品線成長。本季度,調整後的研發費用為 25 億美元,與 LY 相比營運費用下降了 1%。略有下降的主要原因是我們的成本調整計劃導致的支出減少以及某些疫苗項目的支出減少,但這在很大程度上被主要用於開發從 Seagen 收購的某些資產的投資增加所抵消。
Q1 Reported diluted earnings per share were $0.55. Our Adjusted diluted earnings per share was $0.82, which exceeded our expectations due to favorable gross margin performance as well as strong cost management across the enterprise.
Q1 報告的每股攤薄收益為 0.55 美元。我們的調整後每股攤薄收益為 0.82 美元,由於良好的毛利率表現以及整個企業強大的成本管理,這超出了我們的預期。
As I stated earlier, during the quarter, we recorded a favorable product return adjustment associated with our U.S. government contract for PAXLOVID. Recall that during Q4 of last year, we estimated the U.S. government credit for PAXLOVID was $3.5 billion.
正如我之前所說,在本季度,我們記錄了與美國政府 PAXLOVID 合約相關的有利的產品退貨調整。回想一下,去年第四季度,我們估計美國政府對 PAXLOVID 的信貸為 35 億美元。
Earlier this year, the U.S. government announced that the EUA labeled product was no longer authorized for CUs and the agreed-upon return period had now expired. Given those facts, we can now finalize the total value of the U.S. government credit. This resulted in a favorable adjustment to revenues of $771 million for PAXLOVID and contributed $0.11 to the company's earnings per share.
今年早些時候,美國政府宣布,帶有 EUA 標籤的產品不再獲得 CU 授權,且約定的退貨期限已過期。基於這些事實,我們現在可以確定美國政府信貸的總價值。這導致 PAXLOVID 的收入進行了有利的調整,達到 7.71 億美元,並為該公司每股收益貢獻 0.11 美元。
Now let me quickly touch upon our capital allocation strategy, which is designed to enhance long-term shareholder value. Our strategy consists of maintaining and growing our dividend over time, reinvesting in our business at an appropriate level of financial return and making value-enhancing share repurchases after delevering our balance sheet.
現在,讓我簡單談談我們的資本配置策略,該策略旨在提高長期股東價值。我們的策略包括隨著時間的推移維持和增加股息、以適當的財務回報水平對我們的業務進行再投資以及在降低資產負債表槓桿率後進行增值的股票回購。
During the first quarter, we returned $2.4 billion to shareholders via our quarterly dividend, invested $2.5 billion in internal R&D and, as expected, business development activity was minimal in the quarter. We are committed to delivering our capital structure with a gross leverage target of 3.25x, which we expect to achieve over time.
第一季度,我們透過季度股息向股東返還了 24 億美元,在內部研發上投資了 25 億美元,正如預期的那樣,本季的業務發展活動很少。我們致力於實現資本結構中 3.25 倍的總槓桿率目標,並期望隨著時間的推移實現這一目標。
In support of that goal, during the quarter, we paid down approximately $1.25 billion of maturing debt. And in May, we will pay down another $1 billion of outstanding notes. And importantly, during the quarter, we began to monetize our Haleon stake through an initial sale of $3.5 billion, which reduced our equity position in the company from 32% to approximately 23%.
為了實現該目標,本季我們償還了約 12.5 億美元的到期債務。五月份,我們將再償還10億美元的未償票據。重要的是,在本季度,我們開始透過 35 億美元的初始出售將我們的 Haleon 股份貨幣化,這使我們在該公司的股權比例從 32% 減少到約 23%。
Looking ahead to the next couple of quarters, I'd like to point out that we expect operating cash flow to be significantly below typical levels, largely due to the timing of certain payments. Despite this near-term pressure, clearly, our objective is to return to a more balanced capital allocation strategy over time.
展望接下來的幾個季度,我想指出的是,我們預計營運現金流將大幅低於正常水平,這主要是由於某些付款的時間表。儘管面臨短期壓力,但顯然我們的目標是隨著時間的推移恢復更平衡的資本配置策略。
Now let me spend just a few minutes on our outlook for the remainder of this year. As we entered 2024, the company was highly focused on delivering on its financial commitments, and our performance in Q1 demonstrates that we are off to a solid start. With that objective in mind and the fact that it's still early in the year, we are modestly updating the earnings outlook for this year.
現在,請容許我花幾分鐘來談談我們對今年剩餘時間的展望。進入 2024 年,公司高度專注於履行財務承諾,而我們在第一季的表現表明我們已經有了良好的開端。考慮到這一目標以及今年仍處於初期階段的事實,我們正在適度更新今年的獲利前景。
We are raising our full year Adjusted diluted earnings per share guidance range by $0.10 to a new range of $2.15 to $2.35. Looking ahead, this increase takes into consideration both our improving line of sight to our cost savings targets and continued strength in our underlying business. As a reminder, our EPS guidance also includes an anticipated $0.40 of earnings dilution from the Seagen acquisition, largely due to financing costs.
我們將全年調整後每股攤薄收益預期範圍上調 0.10 美元至 2.15 美元至 2.35 美元。展望未來,這一成長既考慮到了我們對成本節約目標的不斷改善,也考慮到了我們基礎業務的持續強勁。提醒一下,我們的每股盈餘指引還包括預計收購 Seagen 會導致的 0.40 美元收益稀釋,這主要是由於融資成本造成的。
While the PAXLOVID revenue return adjustment moves us to the upper end of the revenue guidance range, our top line revenue expectations remain unchanged for the year. We continue to expect revenues in the range of $58.5 billion to $61.5 billion. In addition, even though COMIRNATY revenues continue to perform consistent with our plan, it is important to remember that we expect approximately 90% of our sales to occur in the second half of the year, mostly in Q4, given the seasonal nature of these products.
雖然 PAXLOVID 收入回報調整使我們達到了收入指引範圍的上限,但我們對全年的頂線收入預期保持不變。我們繼續預期營收在 585 億美元至 615 億美元之間。此外,儘管 COMIRNATY 的收入繼續與我們的計劃保持一致,但重要的是要記住,考慮到這些產品的季節性,我們預計約 90% 的銷售額將發生在下半年,主要是在第四季度。
Lastly, we remain on track to deliver at least $4 billion of net savings from our cost realignment program by the end of the year. Improving our cost base will put us on strong footing towards margin expansion and improved financial returns as we move forward.
最後,我們仍有望在年底前透過成本調整計畫實現至少 40 億美元的淨節約。改善我們的成本基礎將為我們未來擴大利潤和提高財務回報奠定堅實的基礎。
As you know, over the past 2 years, the company has made significant investments to drive growth in the back half of the decade, and we remain encouraged by the long-term growth outlook for Pfizer. 2024 is clearly a year of focus, execution and delivering on our near-term financial commitments. The foundation that we establish this year sets the stage to deliver on our commitment to enhance shareholder value, both this year and through the end of the decade.
如您所知,在過去的兩年裡,公司進行了大量投資以推動十年後半段的成長,我們對輝瑞的長期成長前景仍然感到鼓舞。 2024 年顯然是我們專注、執行和兌現近期財務承諾的一年。我們今年奠定的基礎為我們兌現今年乃至整個十年提升股東價值的承諾奠定了基礎。
And with that, I'd like to turn it back over to Albert as we begin our Q&A session.
現在,當我們開始問答環節時,我想將話題轉回給阿爾伯特。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, David. Now let's start the Q&A session. Operator, please assemble the queue.
謝謝你,大衛。現在我們開始問答環節。接線員,請集合排隊。
Operator
Operator
(Operator Instructions) We'll take our first question from Louise Chen with Cantor.
(操作員指示)我們將回答來自 Cantor 的 Louise Chen 提出的第一個問題。
Louise Alesandra Chen - MD & Senior Research Analyst
Louise Alesandra Chen - MD & Senior Research Analyst
I had a question for you on your RSV vaccine sales. Just curious what drove the downtick versus the fourth quarter. It looks like GSK had a similar downtick. And then how do you think about potential competition coming into the market for vaccines and treatments? Does that impact your future growth projections for this franchise?
我有一個關於你們呼吸道合胞病毒疫苗銷售的問題想問你們。我只是好奇是什麼導致了與第四季相比的下滑。看起來葛蘭素史克 (GSK) 也出現了類似的下滑。那麼您如何看待疫苗和治療市場的潛在競爭?這會影響您對該系列未來成長的預測嗎?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
I think, Aamir, that's a question for you, then maybe Alexandre also, you can add because now we started already to register and approve the product in international markets. Aamir?
我想,阿米爾,這是給你的一個問題,那麼也許亞歷山大也一樣,你可以補充一下,因為現在我們已經開始在國際市場上註冊和批准該產品。阿米爾?
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Louise, thanks for the question. So it very much appears like the RSV vaccination market is following a seasonal trend, so you expect the dynamics in Q4 versus Q1 to be different. In Q1, what we saw for the market is for older adults, it certainly attenuated over the course of the quarter. So there was a peak in the second week of January, and then a steady week-by-week decline since then.
路易絲,謝謝你的提問。因此,RSV 疫苗接種市場似乎正在遵循季節性趨勢,因此您預計第四季度與第一季的動態會有所不同。在第一季度,我們看到老年人市場在整個季度中明顯減弱。因此,一月的第二週出現了峰值,然後自那時起逐週穩步下降。
Now in terms of the dynamics for our business and ABRYSVO, our performance was in line with what we expected. We think this will follow a seasonal trend. And we think we're very well positioned for the fall season for several reasons.
現在就我們的業務和 ABRYSVO 的動態而言,我們的表現符合我們的預期。我們認為這將遵循季節性趨勢。我們認為,由於多種原因,我們已為秋季做好了充分準備。
One is we're progressing our retail contracting. Second is we have a real strength in the nonretail channel. You referred to GSK. They reported their revenues. When you look at the mix of U.S. revenues as reported, it's about a 60-40 mix. Our retail share is lower than that, but our nonretail share is much higher. And that portion of our business really doubled between Q4 and Q1 from about 9% to 17%.
一是我們正在推進零售承包。第二,我們在非零售通路擁有真正的優勢。您提到了 GSK。他們報告了他們的收入。如果你看一下報告的美國收入結構,你會發現它大約是 60-40 的比例。我們的零售份額較低,但非零售份額則高得多。我們業務的這一部分在第四季和第一季之間確實翻了一番,從約 9% 增加到 17%。
And I think that just speaks to our strength in doctors' offices and relationships we have with organized customers. And I'll also note that later this year, if approved, we will have a new presentation of ACT-O-VIAL, which demonstrates ease of administration, and also our clinical data, which Albert referred to in his remarks, for label expansion for ABRYSVO for 18- to 59-year-olds as well as -- that are at risk as well as durable efficacy through 2 seasons. I think the combination of these commercial efforts as well as potential label expansion really position us well for a fall season.
我認為這說明了我們在醫生辦公室方面的優勢以及我們與有組織的客戶之間的關係。我還要指出的是,如果獲得批准,今年晚些時候我們將推出 ACT-O-VIAL 的新版本,該版本展示了其易於管理的特點,同時還展示了我們的臨床數據,正如 Albert 在發言中提到的那樣,該版本用於擴展 ABRYSVO 的標籤,適用於 18 至 59 歲人群以及處於危險之中的人群,並且能夠在兩個季節內保持持久的兩個季節內。我認為這些商業努力和潛在的品牌擴張確實為我們在秋季的銷售做好了準備。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Okay. Thank you, Aamir. Now, Alexandre?
好的。謝謝你,阿米爾。現在,亞歷山大?
Alexandre de Germay - Executive VP & Chief International Commercial Officer
Alexandre de Germay - Executive VP & Chief International Commercial Officer
Yes. So Louise, thanks for the questions. On the international front, we actually made great progress on ABRYSVO. As you know, we got approval in the second half of 2023 in Europe and in the U.K. And since then, we've been working with the health authority and the experts to provide medical evidence and health care system benefits associated with the protection against lower respiratory tract infection, as with RSV, and through immunizations of maternal after the immunization of all the others. So we're making good progress.
是的。所以,路易絲,謝謝你的提問。在國際方面,我們在 ABRYSVO 方面實際上取得了巨大進展。如您所知,我們於 2023 年下半年在歐洲和英國獲得了批准。從那時起,我們一直在與衛生當局和專家合作,提供與預防下呼吸道感染(如 RSV)相關的醫學證據和醫療保健系統益處,並在所有其他疫苗接種後對產婦進行免疫接種。所以我們取得了良好的進展。
And actually, we have already received the recommendation in the U.K., in Australia, in Norway, and we are progressing and waiting some recommendations from the vaccine technical committee in many other European markets. We also had good progress from a regulatory standpoint because it was a milestone with the approval of older adults and MI during the maternal immunization in Japan in the first quarter as well as Kingdom of Saudi Arabia.
實際上,我們已經收到了英國、澳洲和挪威的建議,我們正在等待許多其他歐洲市場的疫苗技術委員會的建議。從監管角度來看,我們也取得了良好的進展,因為第一季日本以及沙烏地阿拉伯王國批准了該疫苗用於老年人和孕產婦免疫接種,這是一個里程碑。
So overall, they don't yet translate into financials because it takes time to get to the approval to get VTC and to get funding for those campaigns, but we see significant opportunity that we can address unmet medical need in the international. Just to give you 1 example, in Europe, for instance, half of the hospitalization due to respiratory tract infection in the first year of life were caused by RSV.
因此總體而言,它們尚未轉化為財務收益,因為獲得 VTC 批准和為這些活動籌集資金需要時間,但我們看到了解決國際上未滿足的醫療需求的巨大機會。舉一個例子,例如在歐洲,生命第一年因呼吸道感染而住院的患者中有一半是由呼吸道合胞病毒引起的。
So there is definitely a great opportunity. And the majority of those hospitalizations occurred for the first 3 months of age. And as you know, ABRYSVO is the only maternal vaccine that help protect infants from lower respiratory tract infection caused by RSV immunization from birth through to 6 months. So we see a great opportunity.
因此這絕對是一個很好的機會。大多數住院病例發生在出生後 3 個月內。如您所知,ABRYSVO 是唯一一種可幫助保護嬰兒從出生到 6 個月免受 RSV 免疫引起的下呼吸道感染的母體疫苗。因此我們看到了一個巨大的機會。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Alexandre.
謝謝你,亞歷山大。
Operator
Operator
We'll take our next question from Terence Flynn with Morgan Stanley.
下一個問題來自摩根士丹利的 Terence Flynn。
Terence C. Flynn - Equity Analyst
Terence C. Flynn - Equity Analyst
Maybe just a 2 part from me. Just wondering if you can comment at all about potential impact in 2025 from the Part D redesign. We've heard a couple of other companies already comment here. And then one on the pipeline. Can you give us any update on danuglipron and your plans more broadly in obesity?
也許只是我的第二部分。只是想知道您是否可以評論 D 部分重新設計對 2025 年可能產生的影響。我們聽到其他幾家公司已經在這裡發表評論。然後還有一個在管道上。您能否向我們介紹 Danuglipron 的最新進展以及您在肥胖症領域更廣泛的計劃?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes, thank you. Clearly danuglipron is of interest. Let me take that one so to clear the way. It's not new. We don't have news on danu. Everything is as we have discussed before, so we are waiting around mid-year to get the totality of the data that relates to the once-a-day formulation. And then based on the data and everything else, we will make decision for future plans. So we'll speak about them when we have more to say. However, now let's go to Aamir about the Part D redesign in 2025. Did you expect them?
是的,謝謝。顯然,danuglipron 是令人感興趣的。讓我來處理這個問題,以便掃清道路。這並不是什麼新鮮事。我們沒有關於 danu 的消息。一切都正如我們之前討論的那樣,因此我們正在等待年中左右以獲得與每日一次的配方相關的全部數據。然後根據數據和其他所有因素,我們將製定未來的計劃。所以當我們有更多話要說時我們才會談論它們。但是,現在讓我們來聽聽阿米爾關於 2025 年 D 部分重新設計的看法。您期待他們嗎?
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Sure. Terence, thanks for the question. And as you can imagine, there's many moving parts to Part D redesign. I think relevant to our business, I think it's important to first note that as part of what already went into place with the redesign, there is no cost sharing imposed on vaccines. So that, given our significant vaccines portfolio, is a positive. And then, obviously, over the course of '24 and '25, there's other dynamics with out-of-pocket cost caps, which create better access for patients, and that is helpful to volumes, and we're starting to see that in '24 in some parts of our business, including on VYNDA.
當然。特倫斯,謝謝你的提問。正如您所想像的,D 部分的重新設計涉及許多活動部件。我認為與我們的業務相關的是,首先要注意的是,作為重新設計的一部分,疫苗不分攤任何費用。因此,考慮到我們重要的疫苗組合,這是積極的。然後,顯然,在24年和25年期間,自付費用上限還會出現其他動態,這為患者創造了更好的機會,這對銷量有幫助,我們在24年開始在業務的某些部分看到這一點,包括 VYNDA。
And then there's things to come, including a change in that cap as well as patient smoothing. So we'll see how that plays out. And obviously, there's also changes in how costs are shared between plans, manufacturers, government and patients. So how all of that gets implemented, we're tracking that very closely. We're not offering any specific guidance in terms of direct dollar impact on our business in 2025 because there's still a lot to come on this. And when we are ready to do that, we certainly will.
然後還有一些事情要做,包括改變上限以及讓患者感覺更平滑。我們將看看結果如何。顯然,計劃、製造商、政府和患者之間的成本分攤方式也改變了。我們正在密切關注這一切是如何實施的。我們沒有提供關於 2025 年對我們業務的直接美元影響的任何具體指導,因為這方面還有很多工作要做。當我們準備好這樣做的時候,我們一定會這麼做。
Operator
Operator
We'll take our next question from Akash Tewari with Jefferies.
我們將回答 Jefferies 的 Akash Tewari 提出的下一個問題。
Akash Tewari - Equity Analyst
Akash Tewari - Equity Analyst
On tafamidis, really strong quarter, but I wanted to ask on patent life. Given we've seen the EU patent office write-down multiple invalidity oppositions and on the U.S. side, it looks like defendants are conceding infringement. How should we think about IP for this product? Why shouldn't this patent fit out to 2025? And then number two, really strong quarter for PADCEV and you do have the pending TIVDAK launch in first-line cervical. Is there any possibility we could see Seagen become accretive to Pfizer earnings by next year?
關於 tafamidis,這是一個非常強勁的季度,但我想問專利期限。鑑於我們已經看到歐盟專利局撤銷了多項無效性異議,而在美國方面,看起來被告正在承認侵權。我們該如何思考這個產品的IP?為什麼這項專利不適合到2025年?然後第二個,PADCEV 本季表現非常強勁,並且 TIVDAK 即將在子宮頸一線治療中推出。我們是否有可能在明年看到 Seagen 為輝瑞帶來收益成長?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
That's very good questions. Why don't we go first to you, Dave, to speak a little bit about is doing very well. If you expect that can become accretive earlier. Also, I would like to hear some comments from Chris about the progress of the portfolio, and then Doug can comment on the IP situation, our customers.
這些問題非常好。戴夫,我們何不先和你談談你做得非常好的事情?如果您預計,這可以更早實現增值。此外,我想聽聽克里斯對投資組合進展的一些評論,然後道格可以對智慧財產權情況和我們的客戶發表評論。
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Yes. So just maybe on Seagen from a financial perspective, obviously, clearly a very solid quarter and a very solid start to the year. I think we're not changing our expectations, both short term and long term for Seagen, but I think we're cautiously optimistic as we look forward. So probably nothing to update financially other than our continued commitment to the financial metrics that we've already established. And again, we're probably cautiously optimistic on the trends that we're seeing underlying that business at this point in time.
是的。因此,從財務角度來看,Seagen 顯然本季的業績非常穩健,今年的開局也非常穩健。我認為我們不會改變對 Seagen 的短期和長期期望,但我認為我們對未來持謹慎樂觀的態度。因此,除了繼續致力於我們已經建立的財務指標之外,在財務方面可能沒有什麼需要更新的。而且,我們對目前該業務所呈現的趨勢持謹慎樂觀的態度。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
You want to make some comments also, Chris, about the performance of the Seagen business?
克里斯,您也想對 Seagen 業務的表現發表一些評論嗎?
Chris Boshoff - Executive VP & Chief Oncology Officer
Chris Boshoff - Executive VP & Chief Oncology Officer
Yes, I think just to add to what Dave has said, it's early days for as he pointed out, the 302, the data was -- we just launched early this year. We've already seen 164% year-on-year pro forma growth. It's early but we're very pleased that we've got NCCN Guidelines Category 1. We've got a New England Journal publication. We've got uptake in both academic and community settings. In fact, 70% of the current accounts on the community. And we're looking forward now because I think we're well set for the future in the muscle invasive bladder cancer setting and those 2 studies that we'll read out late in 2025, '26, '27.
是的,我想補充 Dave 所說的話,正如他指出的那樣,現在還為時過早,302 的數據是 - 我們今年年初才推出的。我們已經看到了 164% 的同比增長。雖然還為時過早,但我們非常高興已經獲得了 NCCN 指南第 1 類。我們已經獲得了《新英格蘭醫學雜誌》的出版品。我們在學術和社區領域都得到了認可。事實上,目前 70% 的帳戶都在社區裡。我們現在充滿期待,因為我認為我們已經為肌肉浸潤性膀胱癌的未來做好了準備,我們將在 2025 年末、2026 年、2027 年宣讀這兩項研究。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much, Chris. Doug, what about the situation with the IP disputes?
非常感謝,克里斯。道格,知識產權糾紛的情況怎麼樣?
Douglas M. Lankler - Executive VP & General Counsel
Douglas M. Lankler - Executive VP & General Counsel
Yes. VYNDAQEL and VYNDAMAX currently has U.S. patent exclusivity, excuse me, through the end of this year. But we have a patent pending patent term extension, which would take it out to December of 2028. And we may be filing additional requests for patent term extensions while that is pending. In major European markets, our patents expire in November of 2026. And in Japan, the patent expires in 2026, but there's regulatory exclusivity through March of 2029 for cardiomyopathy.
是的。 VYNDAQEL 和 VYNDAMAX 目前擁有美國專利獨佔權,對不起,有效期到今年年底。但我們有一個正在申請專利的專利期限延長申請,該申請將延長至 2028 年 12 月。在申請期間,我們可能會提交額外的專利期限延長請求。在歐洲主要市場,我們的專利將於 2026 年 11 月到期。在日本,該專利將於 2026 年到期,但對於心肌病變,其獨佔期將持續到 2029 年 3 月。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Doug. Thank you, Akash.
謝謝你,道格。謝謝你,阿卡什。
Operator
Operator
We'll take our next question from Evan Seigerman with BMO Capital Markets.
我們將回答 BMO 資本市場部的 Evan Seigerman 提出的下一個問題。
Evan David Seigerman - MD & Senior BioPharma Research Analyst
Evan David Seigerman - MD & Senior BioPharma Research Analyst
I want to touch on gross margin. Obviously, a nice improvement in this quarter. And I believe, back in December, you had said, for the full year, it would be around 70%. Do you expect that we could actually see a better gross margin for the full year, given kind of the benefit we've seen? Or are there some other puts and takes that we should be aware of?
我想談談毛利率。顯然,本季有了很好的改善。我相信,早在 12 月您就說過,全年成長率將在 70% 左右。考慮到我們已經看到的收益,您是否預計全年毛利率實際上會更高?或者我們還應該注意其他一些利弊?
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Yes, so this is Dave. We're always looking to improve our performance from both a gross margin and operating performance perspective. So I'll say we'll continue to focus on that. Obviously, as you know, there's 3 things that improved our gross margin rate in the quarter. Some of those are temporal. Some of those are more permanent. I think what is encouraging within our gross margin performance is the fact that our cost control element across our manufacturing platform was really strong. We expect that to be -- continue to be a focus.
是的,這就是戴夫。我們始終致力於從毛利率和營運績效的角度提高我們的績效。所以我想說我們將繼續關注這一點。顯然,如您所知,有三件事提高了我們本季的毛利率。其中一些是暫時的。其中一些是更永久的。我認為,我們的毛利率表現令人鼓舞,因為我們的製造平台的成本控制要素非常強大。我們預計這將繼續成為關注的焦點。
But keep in mind that our COMIRNATY volume is very back half weighted. COMIRNATY, as you know, carries because of our profit share carries a very low gross margin rate. So that mix will reverse itself in the back half of the year, compressing and putting pressure on our gross margin rate. So you should expect that dynamic to occur as that product plays itself out through 2024.
但請記住,我們的 COMIRNATY 交易量是後半部加權的。如您所知,COMIRNATY 的利潤份額導致其毛利率非常低。因此,這種結構將在下半年發生逆轉,壓縮並對我們的毛利率造成壓力。因此,您應該預期這種動態會在該產品於 2024 年問世時出現。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much.
非常感謝。
Operator
Operator
We'll take our next question from Vamil Divan with Guggenheim Securities.
下一個問題來自古根漢證券公司的 Vamil Divan。
Vamil Kishore Divan - MD of Healthcare Research & Senior Equity Research Analyst
Vamil Kishore Divan - MD of Healthcare Research & Senior Equity Research Analyst
Congratulations on the quarter. The 2 products I want to just kind of touch on in terms of the sort of newer growth drivers. So one is NURTEC, which came in a little bit lighter than we expected. Obviously, the first quarter there tends to be impacted a lot by gross to net. I'm just trying to understand if you can just give a little more detail on what the dynamics in the quarter and any sort of change to your sort of expectation of that product outlook.
恭喜本季取得佳績。就較新的成長動力而言,我只想談談這兩種產品。一個是NURTEC,它比我們預期的要輕一點。顯然,第一季的毛利與淨利之比往往會受到很大影響。我只是想知道您是否可以更詳細地介紹本季的動態以及您對該產品前景的預期有何變化。
And then the second one on the myeloma side, ELREXFIO. Just noticed in your slide presentation that used to be listed under the sort of key growth drivers in prior quarters. This year, on Slide 9, when your sort of key growth drivers is no longer listed there. So I'm just curious if -- it looks like it was an intentional change. I'm just curious, sort of what drove the decision to move that from the group of key growth drivers?
然後是骨髓瘤方面的第二個藥物,ELREXFIO。剛剛在您的幻燈片演示中註意到,它曾被列在前幾個季度的關鍵增長動力之下。今年,在第 9 張投影片上,您所列舉的關鍵成長動力已不再列出。所以我只是好奇——這看起來像是一個有意的改變。我只是很好奇,是什麼促使您決定將其從關鍵成長動力中移除?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much, Vamil. Aamir, NURTEC, and then Chris, myeloma.
非常感謝,瓦米爾。阿米爾(Aamir),NURTEC,然後是克里斯(Chris),骨髓瘤。
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Thanks for the question, Vamil. So I'm happy to talk a little bit about NURTEC. We'd like to accelerate the momentum of NURTEC, and we're taking several steps to do that. For the quarter itself, what we're encouraged by is the demand and the volumes that we saw. And then on the flip side, as you already alluded to, the performance in the quarter was impacted by gross to net.
謝謝你的提問,瓦米爾。我很高興談論一下 NURTEC。我們希望加速 NURTEC 的發展勢頭,並且正在採取多項措施來實現這一目標。就本季而言,令我們感到鼓舞的是我們看到的需求和數量。另一方面,正如您已經提到的,本季的業績受到了毛利與淨利之比的影響。
So on demand, a few points to just keep in mind. NURTEC continued its market leadership within the class with a 49% TRx share, and that was up 28% from Q1 of last year. Secondly, NBRx share, which we keep a very close eye on, that volume, as a whole, hit its high point since we closed the Biohaven acquisition at the end of '22.
因此,根據需求,只需記住幾點。 NURTEC 繼續保持同類產品的市場領先地位,佔據 49% 的 TRx 份額,比去年第一季成長了 28%。其次,我們密切關注的 NBRx 份額,自我們在 22 年底完成對 Biohaven 的收購以來,該份額整體上達到了最高點。
So that was up versus last year, but also, importantly, up versus Q4 of '23. And there were about 11,000 new NURTEC writers in Q1, and this is 90% of all the new writers within the oral CGRP class. So there's a lot about the volume and the demand that we're encouraged by.
因此,這與去年相比有所上升,但更重要的是,與 23 年第四季相比也有所上升。第一季約有 11,000 名新的 NURTEC 作家,佔口服 CGRP 類別中所有新作家的 90%。因此,數量和需求都讓我們備受鼓舞。
Now on gross to net, there were 3 issues this quarter. One is you typically tend to see this dynamic in the first quarter of every year. We saw that last year, too, just given the benefit design dynamics. Secondly, we did have some payer mix issues between government and commercial channels this quarter. And then finally, there was an unfavorable onetime prior period adjustment to our GTNs in Q1.
現在以總額與淨額計算,本季有 3 起發行。一是,你通常會在每年第一季看到這種動態。去年我們也看到了這一點,只是給了福利設計動態。其次,本季我們確實存在政府和商業管道之間一些付款人組合問題。最後,我們在第一季對 GTN 進行了一次性不利的前期調整。
Your question about the rest of the year, for NURTEC, we expect continued growth. We've talked about the fact -- the fundamentals in terms of untreated patients and undertreated patients remain strong. We also think that some of the gross to net that I described is going to be temporal and will slowly abate over the course of the rest of the year. And then we have made a number of changes in our commercial execution in terms of what we're doing with patient engagement and focusing our field force resources on physician awareness in a different way and also working to reduce friction for patient access. So overall, we do expect continued growth from NURTEC in the balance of '24.
關於您關於今年剩餘時間的問題,對於 NURTEC 而言,我們預計將繼續成長。我們已經討論過這個事實——未經治療的患者和未接受治療的患者的基本面仍然強勁。我們也認為,我所描述的總收入與淨收入之間的部分差異將是暫時的,並將在今年剩餘時間內慢慢減弱。然後,我們在商業執行方面做出了一些改變,包括我們在患者參與方面所做的工作、將我們的現場資源以不同的方式集中在醫生意識上,同時也努力減少患者就醫的摩擦。因此總體而言,我們確實預計 NURTEC 在 24 年內將繼續成長。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you. Chris, about ELREXFIO?
謝謝。克里斯,關於 ELREXFIO 的情況?
Chris Boshoff - Executive VP & Chief Oncology Officer
Chris Boshoff - Executive VP & Chief Oncology Officer
Thank you, Albert. So the reason Albert didn't list ELREXFIO as a major growth driver, just to remind, so he pointed out LORBRENA, XTANDI and PADCEV as the immediate biggest growth drivers for Oncology. But we're absolutely confident that ELREXFIO will become, over the next couple of months and years, a major driver for Oncology.
謝謝你,阿爾伯特。因此,Albert 沒有將 ELREXFIO 列為主要成長動力的原因只是為了提醒,他指出 LORBRENA、XTANDI 和 PADCEV 是腫瘤學領域直接最大的成長動力。但我們絕對有信心,在未來幾個月和幾年內,ELREXFIO 將成為腫瘤學發展的主要動力。
Just a reminder, we've seen very promising efficacy data in highly refractory patient populations with deep and durable responses. And we've reported the longest reported median progressive-free survival in the recurrent relapsed/refractory setting of 17.2 months. Now of course, recognizing there's no definitive conclusion as there's no head-to-head studies. We're currently encouraged by what we've seen with the uptake, with the build of new patient starts as we have planned. And we remain very optimistic with the future from the current indication as well as from the future indications.
需要提醒的是,我們在高度難治性患者群體中看到了非常有希望的療效數據,並且具有深度和持久的反應。我們報告了復發/難治性病例中最長的中位無惡化存活期,為 17.2 個月。當然,現在我們認識到,由於沒有面對面的研究,所以沒有明確的結論。我們目前對所看到的治療進展感到鼓舞,新患者的數量也按照我們的計劃開始增加。從目前的跡像以及未來的跡象來看,我們對未來仍然非常樂觀。
And a reminder that we have 4 ongoing registrational studies in the next 12 months. The first Phase 3 study would read out multiple -- in the MM5 study. We've also recently received J-code for access, and we're smoothing the reimbursement process and continue to gain favorable positions on various pathways, and in some, the most favorable pathways. We're looking forward to update you very soon on more things from ELREXFIO.
提醒一下,我們在未來 12 個月內有 4 項正在進行的註冊研究。第一階段 3 期研究將在 MM5 研究中讀出多個結果。我們最近也獲得了 J 代碼,我們正在簡化報銷流程,並繼續在各種途徑上獲得有利地位,在某些途徑上,甚至是最有利的途徑上。我們期待很快向您更新有關 ELREXFIO 的更多消息。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Chris. And maybe Alexandre, you have anything to add about the product in international markets?
謝謝你,克里斯。也許亞歷山大,您對該產品在國際市場上還有什麼補充嗎?
Alexandre de Germay - Executive VP & Chief International Commercial Officer
Alexandre de Germay - Executive VP & Chief International Commercial Officer
Yes. On ELREXFIO, we actually have -- it's progressing very nicely because, as you know, we got approval in Europe in December of 2023 and in the U.K. in January, and in Japan in March 2024. So we are now moving into reimbursement, ABRYSVO. And we've got early access, considering the clinical profile, the exceptional clinical profile of the product. So that's why we got, in some market, early access, and that's why we started sales in the first quarter.
是的。關於 ELREXFIO,我們實際上已經取得了進展,因為如你所知,我們於 2023 年 12 月在歐洲獲得批准,於 2024 年 1 月在英國獲得批准,於 2024 年 3 月在日本獲得批准。所以我們現在正進入報銷階段,ABRYSVO。考慮到臨床情況,考慮到該產品卓越的臨床情況,我們已經獲得了早期使用權。這就是我們在某些市場獲得早期進入權的原因,也是我們在第一季開始銷售的原因。
But we are very satisfied by that. We could close the time-to-market gap versus competitor. And in some cases, like in Japan, we actually indeed became first-in-class approved. So then we are moving into registrational -- reimbursement discussion and introduction of the product later in the year.
但我們對此非常滿意。我們可以縮小與競爭對手的上市時間差距。在某些情況下,例如在日本,我們確實獲得了同類產品中首個獲得批准的產品。因此,我們將在今年稍後進入註冊——報銷討論和產品介紹階段。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. Overall, in most international markets, there is a gap between the approval and the access round. But because of the profile of the product, we saw early access, which is basically something that happens on an exceptional base if the product is unique. But some countries, before they approve the price, they are allowing you to have access to your own price and that they may be adjusted. So -- but there's a very good signs for this product. We are really feeling very bullish when we see the clinical profile and the opinions of the key opinion leaders.
是的。整體來看,在大多數國際市場,審批與准入輪次之間存在差距。但由於產品的特性,我們看到了早期訪問權,如果產品是獨一無二的,這基本上是在特殊基礎上發生的事情。但是有些國家在批准價格之前,允許您自行設定價格,而且價格可能會進行調整。所以——但是這個產品的跡象非常好。當我們看到臨床概況和關鍵意見領袖的意見時,我們確實感到非常樂觀。
Thank you.
謝謝。
Operator
Operator
We'll take our next question from Dave Risinger with Leerink Partners.
我們將回答 Leerink Partners 的 Dave Risinger 提出的下一個問題。
David Reed Risinger - Senior MD & Senior Research Analyst
David Reed Risinger - Senior MD & Senior Research Analyst
Yes. So how many questions am I allowed to ask?
是的。那我可以問多少個問題?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
You, Dave, you don't have a limit.
戴夫,你沒有限制。
David Reed Risinger - Senior MD & Senior Research Analyst
David Reed Risinger - Senior MD & Senior Research Analyst
Okay. So I have -- I'll keep it to 2. So first, regarding the company's cost structure. I'm just trying to get a sense of whether it bottomed out in the first quarter or if there are additional cost reductions ahead after March 30 such that the cost structure of the company is coming down after the first quarter. And then second, with respect to VYNDAQEL. I appreciate the comments in response to the question earlier, but I'm just trying to get a little bit better understanding of how to think about it.
好的。所以我—我會把它保持在 2 左右。首先,關於公司的成本結構。我只是想知道它是否在第一季觸底,或者在 3 月 30 日之後是否還會進一步削減成本,從而讓公司的成本結構在第一季之後下降。第二,關於 VYNDAQEL。我很感謝之前對這個問題的回答的評論,但我只是想更好地理解如何思考這個問題。
So there was a comment about patent term extension potentially applying beyond December of '28. So if Pfizer is successful, what would the date be instead of December '28 for the U.S.? And then for the EU, the comment was November of '26. But I've heard that there was a positive EU patent development, and I'm trying to understand what that would extend the EU to.
因此有評論稱專利期限延長可能延續到 1928 年 12 月之後。那麼,如果輝瑞公司成功了,那麼美國的日期應該是什麼呢,而不是 12 月 28 日呢?對歐盟來說,該評論是 1926 年 11 月的。但我聽說歐盟專利取得了積極的進展,我想了解這將使歐盟的專利延伸到什麼程度。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much, Dave. So Dave Denton, please, you take the cost structure.
非常感謝,戴夫。所以,請戴夫·登頓 (Dave Denton) 了解一下成本結構。
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Yes. First, as you well know, rightsizing our cost structure is incredibly important for us from -- as we think of forward for margin expansion and improving our financial returns. As we look through Q1 and through the balance of the year, keep in mind that the cost changes that we've made in the U.S. are largely complete. Obviously, in ex U.S., some of those changes lag, but you will see changes in the cost structure ex U.S. for the balance of the year.
是的。首先,眾所周知,優化我們的成本結構對我們來說非常重要——因為我們考慮的是擴大利潤率和提高財務回報。當我們回顧第一季以及全年業績時,請記住,我們在美國所做的成本調整已基本完成。顯然,在美國以外,一些變化是滯後的,但你會看到今年餘下時間美國以外成本結構的變化。
Those are probably not quite as large as we look forward compared to what has already happened at this point. But I would just say that this will be a constant focus for us as we think about cost and margin enhancements going forward. This is a -- now we're on a continual cycle of thinking about how we invest and what is the appropriate cost structure in support of our revenue objectives for this business going forward.
與目前已經發生的情況相比,這些可能並不像我們預期的那麼大。但我想說的是,當我們考慮未來成本和利潤率的提高時,這將是我們持續關注的重點。這是——現在我們正在不斷思考如何投資,以及什麼樣的成本結構適合支持我們未來業務的收入目標。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Dave. And Doug, can you please clarify a few things about VYNDAQEL to Dave Risinger's question?
謝謝你,戴夫。道格,您能否就戴夫·瑞辛格提出的問題就 VYNDAQEL 澄清一些事項?
Douglas M. Lankler - Executive VP & General Counsel
Douglas M. Lankler - Executive VP & General Counsel
Sure. Just to be clear, Dave, we shouldn't think beyond December 2028 on VYNDAQEL and VYNDAMAX. So we've got a patent term extension that is filed and is pending. And all I was saying was that, in addition to that patent term extension, which would take it out to December 2028 that we filed and is pending, we may file additional patent term extensions, again, though, just to take it out to December 2028. I hope that's clear.
當然。需要明確的是,戴夫,我們不應該考慮 2028 年 12 月以後的 VYNDAQEL 和 VYNDAMAX。因此,我們已經提交了專利期限延長申請,目前正在等待批准。我剛才說的是,除了我們提交的、正在審理的專利期限延長至 2028 年 12 月之外,我們可能還會提交額外的專利期限延長申請,但只是將其延長至 2028 年 12 月。我希望我說得清楚。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you for clarifying that.
感謝您澄清這一點。
Operator
Operator
We'll take our next question from Trung Huynh with UBS.
下一個問題由瑞銀的 Trung Huynh 提出。
Trung Chuong Huynh - Analyst
Trung Chuong Huynh - Analyst
Trung Huynh from UBS. One on the ACIP meeting coming up and just a clarification on the guide, if I may. So on ACIP in June, what's your expectation on the recommendation for the 50 to 59 population? Could this be a shared clinical decision like the 60-plus? Would you think this is going to be risk-based? Is there any chance you can get the 18 to 59 data on the agenda for this meeting?
瑞銀的 Trung Huynh。如果可以的話,我想先就即將召開的 ACIP 會議做一個介紹,並對該指南做一些澄清。那麼,在 6 月的 ACIP 會議上,您對 50 至 59 歲人口的建議有何期待?這可能是像 60 歲以上的人一樣共同做出的臨床決策嗎?您認為這是基於風險的嗎?您能否將 18 至 59 的數據納入本次會議的議程?
And just on the guide, a clarification here on the credit for the quarter bec you've kept your $3 billion guide for PAX. I appreciate the comment you're now going to be at the upper end of guide. But on PAX, do you expect to have $770 million less PAX sales than you imagined at the start of the year, given that you updated your EPS guide. Or was this expected?
就指南而言,這裡對本季的信用進行澄清,因為您保留了 PAX 30 億美元的指南。我很欣賞您的評論,您現在將處於指南的上端。但就 PAX 而言,考慮到您更新了 EPS 指南,您是否預計 PAX 銷售額將比年初預期的少 7.7 億美元?或者說這是預料之中的?
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Well, maybe I'll take that first. From a guide perspective, I would not -- we obviously did not expect this final adjustment. It was an estimate that we did at the end of the year. We're now finalizing the adjustment based on the returns that we've seen, and it is now complete. I would say that, as we look forward for the full year, both for PAXLOVID and for the full year of all of our products, we're cautiously optimistic about where we are.
好吧,也許我會先選擇這個。從指導的角度來看,我不會——我們顯然沒有預料到這個最終調整。這是我們在年底做的估計。我們現在根據看到的回報來最終確定調整,目前已經完成。我想說的是,展望全年,無論是對於 PAXLOVID 還是對於我們所有產品的全年,我們對於目前的狀況都持謹慎樂觀的態度。
I think PAXLOVID started off from a very solid utilization. And keep in mind that product will trend consistent with infection rates across the globe. And we're still cautiously optimistic that we will achieve our objective, and we do not expect anything less than our original expectation at this point in time.
我認為 PAXLOVID 從一開始就具有非常穩固的利用率。請記住,產品的趨勢將與全球的感染率保持一致。我們仍然謹慎樂觀地認為我們能夠實現我們的目標,而我們目前所期望的結果不會低於我們最初的預期。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, David. And Mikael, on the ACIP meetings and the June-October recommendations, et cetera.
謝謝你,大衛。還有 Mikael,關於 ACIP 會議和 6 月至 10 月的建議等等。
Mikael Dolsten - Chief Scientific Officer and President of Research & Development
Mikael Dolsten - Chief Scientific Officer and President of Research & Development
Yes. First, to punctuate, good to hear you interested in our RSV vaccine. We have a lot of positive and informative data that's coming in 18 to 59. We have already been out sharing a robust outcome for that. And filing is imminent to happen in U.S. FDA. We also have data coming on second season, full second season and data so far that have been available show robust and probably best-in-class profile for us. And you heard AAMIR mention, we also have new delivery format. So there is a lot of positive things happening to further strengthen ABRYSVO.
是的。首先,強調一下,很高興聽到您對我們的 RSV 疫苗感興趣。我們在 18 至 59 年間獲得了大量積極且有用的數據。我們已經分享了這方面的強勁成果。並且即將向美國 FDA 提交備案。我們還有第二季的數據,完整的第二季數據,到目前為止可用的數據顯示,我們的概況很強勁,可能是一流的。正如您聽到 AAMIR 所提到的,我們還有新的交付格式。因此,有許多正面的事情發生,進一步加強了 ABRYSVO。
For a formal decision on recommendation, ACIP normally wait until a product is FDA approved. We don't know exactly when FDA will potentially approve. We think, clearly, given this unique age range that it can happen to be meaningful for the fall, but that needs to be, of course, pending FDA's views. But we will certainly be very open to share data from several of these new important data sets that could help ACIP to understand the planning of the various RSV products. And we think that would be very helpful for ACIP as Abrysvo data set are robust and, in some sense, unique in a positive way. Thank you.
要做出正式的推薦決定,ACIP 通常要等到產品獲得 FDA 批准。我們不知道 FDA 何時會批准。我們認為,顯然,考慮到這個獨特的年齡範圍,它對於秋季來說可能很有意義,但當然,這需要等待 FDA 的意見。但我們肯定會非常開放地分享這些新的重要數據集的數據,這些數據可以幫助 ACIP 了解各種 RSV 產品的規劃。我們認為這對 ACIP 非常有幫助,因為 Abrysvo 資料集非常強大,而且在某種意義上是獨一無二的。謝謝。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
In general a couple of comments for those -- both of these questions. On the ACIP, we always don't speak for ACIP. So it's not appropriate, so ACIP will do what they think they can do. Of course, typically, as we say, they wait to see FDA approvals, and we hope that they will ask us to present the data in June, but it's something that we don't know. What we know is that whatever they decide, whenever they decide we have prepared our marketing and commercial plans in the U.S., as we do, of course, in other countries so that we can maximize the approvals or the recommendations or the data that we have. So that's 1 thing.
總體而言,針對這兩個問題,我有幾點評論。在 ACIP 上,我們從來都不代表 ACIP 發言。所以這是不合適的,所以 ACIP 會做他們認為他們能做的事情。當然,正如我們所說,他們通常等待 FDA 的批准,我們希望他們會要求我們在六月提供數據,但這是我們不知道的事情。我們知道的是,無論他們做出什麼決定,我們都已經在美國準備好了行銷和商業計劃,當然,我們在其他國家也這麼做,以便能夠最大限度地獲得批准、建議或我們擁有的數據。這是一件事。
The other thing, David explained that we are cautiously optimistic, of course, about -- that comes through the entire line of guidance that we gave. We are cautious in our revenues, cautious about margins. And of course, we improved, again, cautiously that we think the EPS. You need to see all of that in the context of who have been there last year with a big misalignment between what we were expecting to come for COVID and eventually what came.
另一件事,大衛解釋說,我們當然持謹慎樂觀的態度——這來自於我們提供的整個指導方針。我們對收入和利潤都很謹慎。當然,我們再次謹慎地考慮了每股盈餘。你需要結合去年的情況來看待這一切,我們對 COVID 的預期和最終發生的情況之間有很大偏差。
And that it is something that makes us to be double cautious when we speak about projections. We know credibility is extremely important for us. So everything we say, we feel rocket solid, but we will achieve. And we don't say anything more than that, we prefer to achieve rather than be safe. So that as a context to all the guidance that we have provided this time.
當我們談論預測時,我們必須加倍小心。我們知道信譽對我們來說極為重要。因此,我們所說的每一句話,我們都堅信不疑,我們一定會實現。我們只想說,我們寧願取得成就,而不是安全。這就是我們這次提供的所有指導的背景。
Operator
Operator
We'll take our next question from Umer Raffat with Evercore ISI.
我們將回答 Evercore ISI 的 Umer Raffat 提出的下一個問題。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
A couple of financial focused questions, if I may. First, on gross margin. Dave, I remember last time you mentioned 2 specific things: in-sourcing of recently acquired products as well as new launches as being a drag on gross margin. Considering both those things were presumably baked into 1Q, and 1Q looked more like what the historic margin build would have implied, wouldn't that suggest full year margin is tracking meaningfully north of the full year guidance of 70%? Or were there one-offs like some inventory work down from recent acquisitions in 1Q that helped it?
如果可以的話,我想問幾個有關財務的問題。首先,關於毛利率。戴夫,我記得上次你提到了兩件具體的事情:新收購的產品的內部採購以及新產品的發布會拖累毛利率。考慮到這兩件事大概都已計入第一季度,而且第一季看起來更像歷史利潤率所暗示的水平,這難道不意味著全年利潤率將顯著高於全年 70% 的預期嗎?或者是否有一次性事件,例如第一季最近的收購帶來的一些庫存減少,從而對其有所幫助?
And secondly, and maybe this is for you and Albert both. Is there a potential for a significant monetization for some of your excess manufacturing capacity from over the years, be it fill finish or beyond, just considering what the broader environment is and some of the questions on dividend?
其次,也許這對您和阿爾伯特來說都是一件好事。考慮到更廣泛的環境和一些有關股息的問題,多年來你們累積的部分過剩生產能力是否有可能實現大幅貨幣化,無論是填補還是超越?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
I think David can take both of them. Dave?
我認為大衛可以接受這兩件事。戴夫?
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Yes. On the gross margin side, as I said, there is a couple of things that impacted favorably our performance in Q1. The items that you listed of both new product launches and in-sourcing, the in-sourcing is probably a longer-term implication to us because those don't happen in an immediate quarter. So as you think about Seagen, it's probably a multiyear phenomenon that we have here. But I don't think that was an outsized impact to that.
是的。在毛利率方面,正如我所說,有幾件事對我們第一季的業績產生了積極影響。您列出的有關新產品發布和內部採購的項目,內部採購可能對我們來說具有長期影響,因為這些不會在當前季度發生。因此,當您想到 Seagen 時,它可能是我們這裡存在的多年現象。但我不認為這會產生太大的影響。
And obviously, the new launches, we plan for those to be compressing our gross margin rates, of which they did. I think we're off to a very solid start. But keep in mind what I said earlier, in the back half of the year, COMIRNATY sales will begin to ramp up. They compress our gross margin rate fairly significantly, given the partner contribution and payment that we have to our partners. So I would expect that to dampen our gross margin performance in the back half of the year.
顯然,我們計劃推出新產品來壓縮我們的毛利率,事實也確實如此。我認為我們已經有了一個很好的開始。但請記住我之前說過的,今年下半年,COMIRNATY 的銷售量將開始上升。考慮到合作夥伴的貢獻以及我們對合作夥伴的支付,它們相當大程度地壓縮了我們的毛利率。因此我預計這會抑制我們今年下半年的毛利率表現。
Umer, as you well know, we're focused on overdelivery, if we can. So I think we will do everything we can to continue to improve our performance there.
烏默爾 (Umer),如你所知,如果可以的話,我們專注於超額交付。所以我認為我們將竭盡全力繼續提高我們在那裡的表現。
And then finally, as we think about the balance sheet, first and foremost, I just want to reiterate that our #1 priority from a capital allocation perspective is both supporting and growing our dividend over time, and that is not at risk. Secondly, yes, we always look at the assets that we have across our platform and understand what's the best way to capitalize on those assets, and some of that may be monetizing some of that. Some of that may be operating more effectively. So everything is on the table from that perspective.
最後,當我們考慮資產負債表時,首先,我只想重申,從資本配置的角度來看,我們的首要任務是支持和增加我們的股息,而且這不會有風險。其次,是的,我們始終關注我們平台上的資產,並了解利用這些資產的最佳方式,其中一些資產可能會被貨幣化。其中一些可能運行得更有效。從這個角度來看,一切都有可能。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, David. And although your answer was very complete, I will just reiterate something that you said because it seems like that some people, they want to hear it again. The dividend is a sacred cow for us. Dividend, it is secured, and we will continue our policy on dividend as we have promised repeating. And we don't have to monetize things to be able to see that. The reason why we are looking at all our assets is because we want to maximize return on the capital.
謝謝你,大衛。儘管您的回答非常完整,但我還是想重申您說的話,因為似乎有些人想再聽一次。對我們來說,股息是神聖不可侵犯的。股利是有保障的,我們將繼續執行股利政策,正如我們一再承諾的那樣。我們不需要將事物貨幣化就能看到這一點。我們之所以審視所有資產,是因為我們想要最大化資本回報。
And of course, we will see opportunities. I don't know when it makes sense, like the ones that we described, there is serious now issue with the sterile capacity that people are looking to acquire. We will look at everything, but it's not that we are looking right now on this or that because we need to support the dividend, all really to support the delevering opportunities or need to support the investments in the business, right? We can do that without doing any much. Thank you very much.
當然,我們會看到機會。我不知道什麼時候才有意義,就像我們所描述的那樣,人們想要獲得的無菌能力現在有嚴重問題。我們會考慮一切,但我們現在不考慮這個或那個,因為我們需要支持股息,而這一切實際上都是為了支持去槓桿機會或需要支持對業務的投資,對嗎?我們無需做太多的事情就可以做到這一點。非常感謝。
Operator
Operator
We'll take our next question from Geoff Meacham with Bank of America.
我們將回答美國銀行的傑夫‧米查姆 (Geoff Meacham) 提出的下一個問題。
Geoffrey Christopher Meacham - MD
Geoffrey Christopher Meacham - MD
Just have 2 quick ones. The first is now that Seagen has been fully integrated, and you'll see some commercial leverage from the deal, would you expect to see more of a gradual impact on the PADCEV and et cetera, trajectories looking out a few years? Or could you have a more near-term inflection? And then the second question, Dave or Albert, the capital allocation commitment to the dividend is super clear. What we view on Slide 12 as dividend and deleveraging as the 2 highest priorities, or is bolt-on BD still in the mix for this year or next?
只需 2 個即可。首先,現在 Seagen 已經完全整合,您將從這筆交易中看到一些商業槓桿,您是否預計會看到對 PADCEV 等產生更漸進的影響,展望未來幾年的發展軌跡?或者你能有更近期的改變?然後第二個問題,戴夫或艾伯特,對股息的資本配置承諾非常明確。在第 12 張投影片中,我們認為股息和去槓桿是兩個最高優先事項,還是在今年或明年附加 BD 仍然是重點?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. Let's go to Chris to understand the commercial impact on Seagen and how that will take time.
是的。讓我們去找克里斯來了解這對 Seagen 的商業影響以及這將需要多長時間。
Chris Boshoff - Executive VP & Chief Oncology Officer
Chris Boshoff - Executive VP & Chief Oncology Officer
Thank you very much. So as you know, we had a number of months planning prior to close to ensure we had a seamless integration. And we completed cross-training of our commercial field force teams in January, especially for breast cancer, between TUKYSA and IBRANCE, but also hematology between ADCETRIS and ELREXFIO. And we should start seeing that further playing out now over the coming months.
非常感謝。如您所知,我們在結束之前進行了數月的規劃,以確保無縫整合。我們在一月份完成了商業現場團隊的交叉培訓,特別是針對乳癌的 TUKYSA 和 IBRANCE 之間的交叉培訓,以及 ADCETRIS 和 ELREXFIO 之間的血液學交叉培訓。我們應該會在接下來的幾個月看到這一現象的進一步發展。
As we've mentioned, we're obviously very pleased that there's been tremendous colleague retention, so we haven't had an issue with colleague retention, both from the legacy Pfizer and the legacy Seagen organization as we build a new business.
正如我們所提到的,我們非常高興看到員工留任率很高,因此在建立新業務時,無論是來自傳統的輝瑞公司還是來自傳統的 Seagen 組織,我們都沒有遇到員工保留的問題。
We expect PADCEV to continue to do well. There's significant enthusiasm from health care providers, from patients, from patient advocacy groups because of the groundbreaking data, double the overall survival. So we are confident that we'll continue to see PADCEV growth.
我們預計PADCEV將繼續表現良好。由於這項突破性的數據,整體存活率提高了一倍,醫療保健提供者、患者和患者權益團體都展現了極大的熱情。因此我們有信心繼續看到 PADCEV 的成長。
We've also seen TUKYSA, for instance, 21% year-over-year pro forma basis growth. And in fact, the last quarter was the highest performance of TUKYSA. So overall, great confidence, and we started the first new Phase 3 study with an NME from the Seagen portfolio with a secret attack. and we hope to update you on other Phase 3 studies from the legacy Seagen portfolio.
例如,我們也看到 TUKYSA 的預期基礎年增了 21%。事實上,上一個季度是 TUKYSA 業績最高的一個季度。所以總的來說,我們很有信心,並且我們利用 Seagen 產品組合中的 NME 進行了秘密攻擊,開始了第一階段新的第 3 階段研究。我們希望向您通報 Seagen 傳統產品組合中的其他第 3 階段研究的最新進展。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
From my perspective, yes, of course, we have invested so much into this business, and we think that this is an area that we can make a huge difference to the world. I'm monitoring that very closely. I'm very impressed actually, I would say, nicely surprised on the positive side how well both on the Pfizer impact of day 1 plus 1 equals 3 rather than 2. But already, we'll start seeing it both in the research organization because we are putting now a lot of Phase 3 on starts.
從我的角度來看,是的,當然,我們已經在這個行業投入了大量資金,我們認為這是一個我們可以為世界帶來巨大改變的領域。我正在密切關注此事。實際上,我想說,我印象非常深刻,從積極的一面來看,我對輝瑞第一天加 1 等於 3 而不是 2 的影響感到非常驚訝。但是,我們已經開始在研究機構中看到它了,因為我們現在正在啟動許多第三階段的工作。
And you don't see but I have high visibility on what's going on in earlier stages where we put a lot of stuff in the clinic. And then also in the commercial, that you can see now stabilization for IBRANCE on the Pfizer side, and then high growth of the seeds and assets despite the fact that, as I said, you should expect a decline in the first 6 months.
您可能看不到,但是我對我們在臨床上進行的早期階段的工作有很高的了解。然後從商業角度來看,您現在可以看到輝瑞方面的 IBRANCE 趨於穩定,種子和資產也實現了高速增長,儘管正如我所說,您應該預計前 6 個月會出現下滑。
When you have an integration, always, we have a decline. I haven't seen a single integration that we have done, but it didn't face challenges because people are changing territories, people are changing let's say, jobs, marketers are moving around.
當你進行整合時,我們總是會經歷衰退。我還沒有看到我們進行過任何一次整合,但它沒有面臨挑戰,因為人們在改變領域,人們在改變,比如說,工作、行銷人員都在四處流動。
All of that creates, let's say, a disruption here. We can be of -- we have very, very strong growth on both sides. So I'm really, really pleased. Not of course, will take time to see the full benefit. But certainly, under Chris' leadership, and he has formed a terrific team, we are off to a very good start.
所有這些都造成了這裡所謂的混亂。我們可以—雙方都實現了非常非常強勁的成長。所以我真的非常高興。當然不是,需要花一些時間才能看到全部的好處。但可以肯定的是,在克里斯的領導下,他組建了一支出色的團隊,我們已經有了一個非常好的開始。
Now Dave, why don't you take or the next question?
現在戴夫,你為什麼不回答下一個問題呢?
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
So as it relates to your question regarding capital allocation, clearly, our first priority, our #1 priority is supporting both the dividend as well as delevering our balance sheet. So that is job 1 from my perspective. As it relates to bolt-on acquisitions, in the near term, you would not expect us to do much there. We are -- that is a lower priority in the near term until we get ourselves. I hope that helps.
因此,就您關於資本配置的問題而言,顯然,我們的首要任務,我們的首要任務是支持股利以及降低資產負債表的槓桿率。從我的角度來看,這是第一要務。就附加收購而言,短期內你不會指望我們在那裡做太多的事情。我們 — — 在我們解決自身問題之前,這在短期內是一個較低的優先事項。我希望這能有所幫助。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you.
謝謝。
Operator
Operator
We'll take our next question from Srikripa Devarakonda with Truist.
我們將回答 Truist 的 Srikripa Devarakonda 提出的下一個問題。
Srikripa Devarakonda - Associate
Srikripa Devarakonda - Associate
Congrats on the progress. I have a question about your breast cancer franchise from the IBRANCE perspective. You have pivotal data from the estrogen receptor, PROTAC, the collaboration with partnership with Arvinas expected later this year. One is, what are your expectations for these data? And how important are these data for you to make decisions around either continuing or initiating combo Phase 3 trials, like whether it's CDK4/6 combo or CDK4 combo or both of them?
祝賀你取得進展。我從 IBRANCE 的角度對您的乳癌特許經營權有一個疑問。您擁有來自雌激素受體 PROTAC 的關鍵數據,與 Arvinas 的合作預計於今年稍後完成。一是,你對這些數據有什麼預期?這些資料對於您做出繼續或啟動第 3 階段組合試驗的決策有多重要,例如是 CDK4/6 組合還是 CDK4 組合或兩者兼而有之?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much. Chris?
非常感謝。克里斯?
Chris Boshoff - Executive VP & Chief Oncology Officer
Chris Boshoff - Executive VP & Chief Oncology Officer
Yes. Thank you very much for the question. Just a reminder to point out with IBRANCE that over 773,000 patients have now been treated globally with IBRANCE. So it is currently still the CDK4/6 leader. We're very excited about 2 programs: vepdegestrant, which we believe to be best-in-class next-generation receptor degrader and also atimociclib, next-generation CDK4 specific inhibitor.
是的。非常感謝您的提問。需要提醒的是,目前全球已有超過 773,000 名患者接受 IBRANCE 治療。所以目前它仍然是CDK4/6的領導者。我們對這兩個計畫感到非常興奮:vepdegestrant,我們認為它是一流的下一代受體降解劑,還有atimociclib,下一代 CDK4 特異性抑制劑。
For, as you point out, we'll get the data later this year for VERITAC-2, but we are planning additional studies at ROTH. You can expect to see first-line studies, both first-line study with atimociclib and standard of care endocrine therapy as well as a termocyclib-plus brand. (inaudible) as you've seen in a heavily pretreated population, we've seen an overall response rate of 32% with medium progressive survival of 8.1 months. We're therefore highly encouraged.
正如您所指出的,我們將在今年稍後獲得 VERITAC-2 的數據,但我們計劃在 ROTH 進行其他研究。您可以期待看到一線研究,包括使用 atimociclib 的一線研究和標準護理內分泌治療以及 termocyclib-plus 品牌。 (聽不清楚)正如您在接受過大量治療的人群中看到的那樣,我們的總體反應率為 32%,中等進展生存期為 8.1 個月。因此,我們受到很大的鼓舞。
I'm definitely very encouraged by the safety profile and we see more continuous dosing, very good compliance and more complete coverage of CDK4, and that's why we're confident to accelerate CDK4 into a registration strategy and the first study has already started, as you know, the second-line study.
我對安全性感到非常鼓舞,我們看到了更持續的給藥、非常好的依從性和更完整的 CDK4 覆蓋範圍,這就是為什麼我們有信心加速 CDK4 納入註冊策略,並且第一項研究已經開始,正如你所知,二線研究也已經開始。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Chris.
謝謝你,克里斯。
Operator
Operator
We'll take our next question from Carter Gould with Barclays.
我們將回答巴克萊銀行的卡特古爾德提出的下一個問題。
Carter Lewis Gould - Senior Analyst
Carter Lewis Gould - Senior Analyst
I wanted to ask a follow-up as I think it's important, and I fully respect the focus on '24 and Albert's commentary on conservatism around guidance. But to come back to the IRA impact for thinking about '25. When do you think you'll be in a better position to comment a little bit on you're contracting discussions are underway pretty late in the earnings season here, and most of your peers have already made comments and your Part D exposure isn't exactly a surprise. So any color there on time line would be helpful. And I guess for David, you talked about the operating margin improvement being sort of a multiyear process. Is there a risk that the IRA sort of presents a little bit of a hiccup to that in '25?
我想問一個後續問題,因為我認為這很重要,我完全尊重對『24』的關注以及阿爾伯特對指導保守主義的評論。但讓我們回到愛爾蘭共和軍對 25 年的影響的思考。您認為什麼時候您能更有資格對您的合約討論發表一些評論?合約討論已經在收益季節的後期進行了,您的大多數同行已經發表了評論,而您的 D 部分曝光並不令人意外。因此時間線上的任何顏色都會有幫助。我想對大衛來說,您說過營業利潤率的提升是一個多年的過程。愛爾蘭共和軍在 25 年是否會對此造成一點阻礙?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Aamir, do you have any comments on that?
阿米爾,您對此有什麼評論嗎?
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Sure. So Carter, I think you heard us describe the dynamics. And later this year, we will have more clarity on what that means. And so we can certainly share that. I think there's also a specific question that comes up often about Eliquis, so let me just address that now because we are clearly in a live negotiation on that.
當然。卡特,我想你聽到我們描述了動態。今年晚些時候,我們將更加清楚地理解這意味著什麼。所以我們當然可以分享這一點。我認為關於 Eliquis 還有一個經常被提及的具體問題,所以我現在就來回答這個問題,因為我們顯然正在就此進行現場談判。
BMS, our alliance partner, is leading that process. You've heard them describe, and we also described that there will be transparency around the outcome of that for impact in '26 in the September time frame. And so at that point, we'll be in a position to share more.
我們的聯盟夥伴 BMS 正在領導這項進程。您已經聽到了他們的描述,我們也描述說,在 9 月期間,其影響結果將會透明化。因此到那時,我們將能夠分享更多資訊。
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Yes. And I guess, as it relates to 2025 and the impact of the IRA from a margin expansion perspective, I would say, without giving any specifics on that is, as we look forward, we obviously run multiple scenarios around how our business might perform. And in those scenarios, we would model different impacts to the IRA because it's still unclear because it's still a lot of moving parts, specifically as we just spoke about. Under those scenarios, we will work hard to offset any implication we might have through improving our cost structure.
是的。我想,至於它與 2025 年以及 IRA 對利潤擴張的影響,我想說,無需提供任何具體細節,展望未來,我們顯然會圍繞我們的業務表現運行多種情景。在這些情況下,我們會對 IRA 模擬不同的影響,因為它仍然不清楚,因為它仍有許多活動部件,具體來說就像我們剛才談到的。在這種情況下,我們將努力透過改善成本結構來抵消可能產生的任何影響。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
And I want on the IRA, and also, we said something, but clearly, in 2025, we will have 2 events that are happening, which are -- we will have to contribute to -- as a pharmaceutical industry, so that will put pressure on the pricing, let's say. But also, because of the significant pains in the out-of-pocket dynamics, and which I hope that will be implemented, as the law says, immediately because I'm hearing efforts to try to play with that.
我想要 IRA,而且,我們也說過一些事情,但顯然,在 2025 年,我們將會面臨兩件大事,作為製藥業,我們必須為此做出貢獻,因此這將對定價造成壓力。但是,由於自付費用動態方面存在巨大的痛點,我希望這一點能夠按照法律規定立即實施,因為我聽說有人試圖利用這一點。
But if that is the case, which we are certain because that's the law, we will see significant drug uptake, right, for everyone, not for us, of course, for everyone because there is a huge number of abandonment that is happening at the pharmacy level when people are asked to pay this very high out-of-pocket, particularly the first 1 quarter and maybe 2 when they need to exhaust their, let's say, their co-pays or the deductible.
但如果情況確實如此,而我們對此很確定,因為這是法律規定的,我們將看到藥物使用量大幅增加,對吧,對每個人來說都是如此,當然不是對我們而言,而是對每個人來說都是如此,因為當人們被要求支付如此高昂的自付費用時,在藥房層面發生了大量放棄用藥的情況,特別是在前 1 季度和賠額可能
So that, I think, dynamic, you know that the industry always asks that we contribute to the out-of-pocket payments as long as the patients are paying less because there is a significant benefit for all: for health care system, for the patients, for us. And so I'm not that concerned about that for the industry as a whole. I'm very concerned for the industry as a whole with the mandatory cost reduction. There is no negotiation there. They are just cutting prices, but are occurring for biologics and for more volumes, particularly.
所以,我認為,你知道,只要病人支付的費用較少,業界就會一直要求我們為自付費用做出貢獻,因為這對所有人都有重大益處:對醫療保健系統、對病人、對我們。所以我並不那麼擔心整個產業的情況。強制降低成本對整個產業的影響我非常擔憂。那裡沒有談判。他們只是在降價,但這尤其適用於生物製劑,並且是為了增加產量。
One good thing for us, it is, first of all, that we have good exposure on vaccines, that they are a part of that, actually, they are benefiting from the IRA because there is no cost sharing. So we can see that in the volumes again. But on the small molecules where we do have exposure, I would say that we were like only 1 product that was selected for '26, we would have 3 or 4, and only 1 was selected. So Eliquis, as Aamir said, we will wait to see. We know, of course, but we can't discuss in the middle of negotiations about anything that's happening. And so we'll see the impact of whatever about this in 2026.
對我們來說有一件好事,首先,我們在疫苗方面有很好的曝光率,他們是其中的一部分,實際上,他們從 IRA 中受益,因為無需分攤成本。我們可以再次在卷中看到這一點。但在我們確實有接觸的小分子產品方面,我想說的是,我們在 26 年只有 1 種產品被選中,我們會有 3 或 4 種產品,但只有 1 種被選中。因此,正如阿米爾所說,對於 Eliquis,我們將拭目以待。我們當然知道,但我們不能在談判期間討論正在發生的任何事情。因此,我們將在 2026 年看到這件事情的影響。
Then if next year, they bring some of the other products that they've been included and they were not in this year, that will be the IBRANCE of the world, that will be the XTANDIs, those are products that anyway, they are approaching their LOE. So even if they come into the IRA, the MPV risk that we have in place is not that big because really, we cut the price for something, but it will not be for a very lengthy period of time, but will be for smaller than others period of time. This doesn't mean that this is not very bad for the industry and for innovation, and we clearly opposing and he will try whatever we can to defend it.
那麼如果明年他們帶來一些已經列入但今年沒有列入的其他產品,那將是全球的 IBRANCE,那將是 XTANDI,無論如何,這些都是他們正在接近 LOE 的產品。因此,即使他們進入 IRA,我們所面臨的 MPV 風險也不會那麼大,因為實際上,我們會降低某些產品的價格,但不會持續很長一段時間,而是會比其他時間段更短。這並不意味著這對產業和創新來說不是很糟糕,我們明確反對,他會盡一切努力捍衛它。
Operator
Operator
We'll take our next question from Rajesh Kumar with HSBC.
我們將回答匯豐銀行的 Rajesh Kumar 提出的下一個問題。
Rajesh Kumar - Analyst
Rajesh Kumar - Analyst
First question is you very helpfully provided some color on the gross margin. What are the takes and puts there? If we look at your early 70s guidance and the gross margin you've achieved in Q1, do we see below 70s gross margin some point in some quarter this year? Or you sort of will get to early 70s with throughout the year, maintaining over 70% margin? And then the bit which is quite difficult to work out from the disclosures is, how did the PAXLOVID number impact the gross margin? So any help there so that we can model that right would be much appreciated.
第一個問題是,您非常有幫助地提供了一些有關毛利率的資訊。那裡有什麼得失?如果我們看一下您早期的 70 年代指引和您在第一季實現的毛利率,我們是否看到今年某個季度的某個時候毛利率低於 70 年代?或者您將會在全年中保持 70% 以上的利潤率,達到 70 年代初期的水平?那麼,從揭露數據中很難得出的一點是,PAXLOVID 數字對毛利率有何影響?因此,任何有助於我們建模的幫助都將不勝感激。
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Okay. Great. So yes, I think we just gave some color around gross margin being closer to 70% versus closer to 80% when we entered 2024. We are maintaining that color at this point in time. I would say that it's unlikely for our gross margin rate to fall below 70% in any given quarter. But I want to just emphasize the gross margin rate will fluctuate a bit, primarily given the mix of sales, specifically within the vaccine portfolio, which carries a lower gross margin, number one.
好的。偉大的。所以是的,我認為我們剛剛給出了一些關於毛利率的信息,即接近 70%,而當我們進入 2024 年時,毛利率接近 80%。我們目前保持這種狀態。我想說我們的毛利率在任何季度都不太可能低於 70%。但我想強調的是,毛利率會有一點波動,主要是考慮到銷售組合,特別是在疫苗組合中,其毛利率較低,這是第一。
Number two, when you look at our performance for gross margin in Q1, a dominant effect of that versus last year is the mix, the lower sales volume of COMIRNATY in the quarter in Q1 versus last year's Q1. Obviously, the final adjustment of the PAXLOVID reserve actually did also have a onetime positive impact on the gross margin rate in Q1, but that was less of an impact compared to the mix. So I hope that helps.
第二,當您查看我們第一季的毛利率表現時,與去年相比,一個主要的影響是組合,與去年第一季相比,COMIRNATY 第一季的銷售量較低。顯然,PAXLOVID儲備的最終調整實際上也對第一季的毛利率產生了一次性積極影響,但與組合相比,影響較小。我希望這會有所幫助。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
And as I want to emphasize that on PAXLOVID, what really makes me pleased it is the underlying demand of the product, right? So it was approximately in the first quarter only in the U.S., 2 million scripts, right? So that's significant. And keep in mind that this was the quarter that we moved from a previous way of go-to-market approach to a commercial model, right? That had a lot of minefields in execution, but we didn't step into any of them. So it was Again, I'm very pleased how Aamir and the U.S. team executed on that. Meticulous execution. So we have a very smooth transition with very low co-pays on the commercial plans.
我想強調的是,關於 PAXLOVID,真正讓我感到高興的是該產品的根本需求,對嗎?那麼第一季光在美國就有大約 200 萬份劇本,對嗎?這很重要。請記住,這個季度我們從之前的行銷方式轉向商業模式,對嗎?在執行過程中有很多雷區,但我們沒有踩到任何一個。所以再次重申,我對阿米爾和美國隊的表現非常滿意。一絲不苟的執行。因此,我們的過渡非常順利,商業計劃的共付額非常低。
For the vast majority of the insured lives and then at the same time, very good execution with thousands of participating, almost 90,000 pharmacies, if I remember Well, of 90% of the is participating into the Medicare part. And that went extremely well. And also I want to remind that the Medicare that goes clearly with different price level because it is through the credit of the U.S. government compared to the commercial plans, that they are at 1,000, it's a different list price. And that difference exists for this year. Next year, everybody moves to the list price, and of course, the discounts that we give any. Let you over to Case, please.
對於絕大多數受保人來說,同時,執行情況也非常好,有數千家藥店參與,如果我沒記錯的話,差不多有 90,000 家藥店,其中 90% 都參與了醫療保險部分。一切進展順利。而且我想提醒的是,醫療保險顯然有不同的價格水平,因為它是透過美國政府的信貸提供的,與商業計劃相比,它們的標價是 1,000,這是不同的。今年的情況確實存在差異。明年,每個人都會以標價購買,當然,我們也會給予折扣。請將您交給 Case。
Operator
Operator
We'll take our next question from Chris Shibutani with Goldman Sachs.
下一個問題由高盛的 Chris Shibutani 提出。
Chris Shibutani - Research Analyst
Chris Shibutani - Research Analyst
Two questions, if I may. The first on pneumococcal vaccines with Prevnar as well. Last quarter, you provided some commentary about your thoughts on the tone of the markets, particularly for adult being somewhat more mature. And obviously, competition is coming across the different categories, adult and pediatrics. Can you comment about your view, given that performance was relatively strong and how you're preparing for competition?
請問我有兩個問題。第一個關於肺炎鏈球菌疫苗的藥物是Prevnar。上個季度,您就市場基調的看法發表了一些評論,特別是對於成年人來說,市場基調變得更加成熟。顯然,競爭來自於成人和兒科等不同類別。鑑於表現相對較強,您能否評論一下您的看法以及您如何為比賽做準備?
The second question I have is on commercial models. There has been some nascent efforts in the industry to go more direct to consumers, for instance, Lilly has direct for their obesity products. Aamir, I'm curious about your thoughts about integrating this type of approach, particularly as I think about certain product categories that you have like migraines and NURTEC, how might this work? Where is Pfizer in terms of exploring these opportunities?
我的第二個問題是關於商業模式。業界已經開始了一些嘗試,更直接地面向消費者,例如禮來公司就已開始直接面對其減肥產品。阿米爾,我很好奇您對整合這種方法的想法,特別是當我想到您所擁有的某些產品類別,例如偏頭痛和 NURTEC,這種方法將如何發揮作用?輝瑞在探索這些機會方面處於什麼位置?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Aamir?
阿米爾?
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Okay. Chris, thanks for the question. So on Prevnar, you alluded to the commentary we provided around dimensionalizing the market, and I think it's worthwhile just reiterating that. So the adult market continues to contract and that's for 2 reasons. There are increasingly fewer eligible 65-plus adults. And then the 19 to 64 underlying medical conditions, population is obviously more difficult to activate. So that is a dynamic that is true for our business, but it's also true for any competitor that's going to come into the adult vaccine market. So I think that's important to note.
好的。克里斯,謝謝你的提問。因此,在 Prevnar 上,您提到了我們圍繞市場維度提供的評論,我認為值得重申這一點。成人市場持續萎縮,原因有二。符合資格的65歲以上成年人越來越少。而19到64歲患有基礎疾病的人群,顯然激活難度更高。所以這對我們的業務來說是一個真實的動態,但對於任何進入成人疫苗市場的競爭對手也是如此。所以我認為這一點值得注意。
Now for our overall franchise, we continue to expect growth. We did very nicely in Q1. We saw 6% growth. And the big driver of that is increased uptake as well as market share growth in the pediatric. So pediatrics in Q1 saw a lot of conversion, PCV 13 to 20. And our share exiting Q1 was at 80%, and that was from 71% at the time of launch of PCV 15. So we see good momentum on pediatrics.
現在,對於我們的整體特許經營權,我們繼續期待成長。我們在第一季的表現非常出色。我們看到了6%的成長。其中最大的驅動力就是兒科市場的接受度和市佔率的成長。因此,第一季的兒科市場出現了許多轉變,從 PCV 13 到 20。我們在第一季結束時的份額為 80%,而在 PCV 15 推出時該份額為 71%。因此,我們看到兒科市場發展勢頭良好。
Now back to your question about the adult segment and competition. We're continuing to see very good performance where we are. We have 98% market share. We acknowledge that V116 is coming. And as Albert alluded to earlier, we're not going to speculate on what the regulatory outcomes or recommendations are going to be. But there are a number of things that we can do to defend our business in the adult segment. Firstly, we have a portfolio approach to contracting that we're deploying in the retail setting but also in the nonretail setting.
現在回到你關於成人部分和比賽的問題。我們繼續看到我們所在領域的出色表現。我們擁有98%的市佔率。我們承認 V116 即將到來。正如阿爾伯特之前提到的,我們不會猜測監管結果或建議是什麼。但我們可以採取一些措施來捍衛我們在成人市場的業務。首先,我們採用組合承包方式,這種方式不僅在零售環境中採用,而且在非零售環境中也採用。
And it's also important to note that in the nonretail setting, many organized customers have a preference for workflow management to stock 1 vaccine that satisfies all the current ACIP recommendations. So until we know more, I think the best way to defend our share in the adult segment is to continue to do what we're doing. And that's to be laser-focused on maximizing the opportunity that we have in the adult segment, albeit contracting and then continue to drive growth in pediatrics.
還需要注意的是,在非零售環境中,許多有組織的客戶傾向於透過工作流程管理來儲備 1 種符合所有當前 ACIP 建議的疫苗。因此,在我們了解更多之前,我認為捍衛我們在成人市場中的份額的最佳方法是繼續做我們正在做的事情。我們將專注於最大限度地利用我們在成人市場的機會,儘管成人市場正在萎縮,但我們仍將繼續推動兒科市場的成長。
On your second question around consumers, look, engaging and activating consumers is, as you pointed out, a very, very important part of our business. It's true in vaccines. It's true in categories like PAXLOVID and NURTEC, just to name a few examples. And we're always looking at ways to enhance that connection. One example I'll point to is the work that we've done on VAXassist as a mechanism to help consumers determine their vaccine eligibility but also book appointments. And that's a really good example of value that we can bring. And to the extent that we can do more of that, create value for patients as well as for our business in other categories, we'll certainly look to explore that.
關於您關於消費者的第二個問題,正如您所指出的,吸引和激活消費者是我們業務中非常非常重要的一部分。對於疫苗來說確實如此。僅舉幾個例子,PAXLOVID 和 NURTEC 等類別確實如此。我們一直在尋找加強這種聯繫的方法。我要指出的一個例子是我們在 VAXassist 上所做的工作,它是一種幫助消費者確定他們的疫苗接種資格並預約的機制。這就是我們可以帶來的價值的一個很好的例子。只要我們能夠做得更多,為患者以及其他類別的業務創造價值,我們一定會努力探索。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Alexandre, very quickly, anything on PCV in international markets?
亞歷山大,請問國際市場上有關於 PCV 的資訊嗎?
Alexandre de Germay - Executive VP & Chief International Commercial Officer
Alexandre de Germay - Executive VP & Chief International Commercial Officer
Yes. No, we had a great quarter. As you know, we grew by 8% operationally. But more importantly, we also have achieved some key milestones. So we got the European approval of pediatric Prevnar 20 in Europe. We also got it approved in Japan, which are very important market in Australia and many others. So this is great because then we want to build on the very successful Prevnar 13 franchise around the world. As you know, we have exclusive NIP standards in 130 market, and now we're going to be able to build on that.
是的。不,我們度過了一個美好的季度。如您所知,我們的營運成長了 8%。但更重要的是,我們也實現了一些重要的里程碑。因此我們獲得了兒科Prevnar 20在歐洲的批准。我們也獲得了日本的批准,日本是澳洲和許多其他國家非常重要的市場。這非常棒,因為我們想在世界各地拓展非常成功的 Prevnar 13 系列產品。如您所知,我們在 130 市場擁有獨家的 NIP 標準,現在我們將能夠在此基礎上繼續發展。
Just 1 comment on the Adults. We still are in the process of getting VTC recommendation in most of the European markets. But when we got it in Germany and in France, we see a very nice pickup. And why? Because they extended the population covered by the Prevnar 20 Adult. For instance, in Germany, gave us 18 to 59 population at risk and all-comers, 60 and above. And since that and we got this recommendation in February, we get very nice pickup in utilization in Germany, and we are about to launch in France as we speak. So in Adults, as well, we see a great potential of growth.
對成年人只有 1 則評論。我們仍在爭取在大多數歐洲市場獲得 VTC 推薦。但當我們在德國和法國買到它時,我們看到了一款非常漂亮的皮卡。為什麼?因為他們擴大了Prevnar 20 Adult 疫苗覆蓋的人口。例如,在德國,我們列出了18至59歲的高危險群和60歲以上的所有人群。自那時起,我們在二月得到了這個建議,我們在德國的使用率得到了很好的提升,而且我們即將在法國推出這項服務。因此,在成年人中,我們也看到了巨大的成長潛力。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
It's a very nice cadence of approval and recommendation.
這是非常好的贊同和推薦的節奏。
Operator
Operator
We'll take our next question from Mohit Bansal with Wells Fargo.
下一個問題由富國銀行的 Mohit Bansal 提出。
Mohit Bansal - Senior Equity Analyst
Mohit Bansal - Senior Equity Analyst
Maybe a question for Dave. Just wanted to understand the cadence of margin improvement as you are embarking on the cost management journey throughout the year because I mean, you had a really high EPS because of the onetime item, but if you think about margin profile over the year, how should we think about it? I understand fourth quarter could be impacted with COMIRNATY revenues. And then when we get into 2025, should we think about better leverage or do you think there could be more opportunity to reduce expenses in '25 as well?
這可能是給戴夫的一個問題。只是想了解您在全年開始成本管理之旅時利潤率改善的節奏,因為我的意思是,由於一次性項目,您的每股收益非常高,但如果您考慮全年的利潤率狀況,我們應該如何考慮它?我知道第四季度的收入可能會受到 COMIRNATY 收入的影響。那麼,當我們進入 2025 年時,我們是否應該考慮更好的槓桿作用,或者您是否認為在 2025 年也可能有更多機會削減開支?
David M. Denton - CFO & Executive VP
David M. Denton - CFO & Executive VP
Yes, thank you for the question. I would say that without giving -- since we don't guide to quarterly expectations for gross margin, I would just say that the focus that we have around improving our cost of goods sold is a multiyear journey. And these costs that we are working to improve take time to adjust and to further implement ways to be more effective and efficient in this infrastructure.
是的,謝謝你的提問。我想說的是,由於我們沒有給出季度毛利率預期,我只想說,我們對改善銷售成本的關注是一個多年的歷程。我們正在努力改善的這些成本需要時間來調整,並進一步實施更有效、更有效率的基礎設施方法。
So I wouldn't think of that having a significant impact on 2024 but more -- if it would, it would be late 2024 but more '25 and '26. But more to come. As we know more and as we develop our plans more specifically, we'll be certain to share some specifics around that.
因此,我認為這不會對 2024 年產生重大影響,而更嚴重的是 — — 如果會產生影響,那將是 2024 年末,但更多的是 2025 年和 2026 年。但接下來還會有更多。隨著我們了解得越來越多,並且我們計劃的越來越具體,我們一定會分享一些具體資訊。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you.
謝謝。
Operator
Operator
We'll take our next question from Chris Schott with JPMorgan.
下一個問題來自摩根大通的 Chris Schott。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Just 2 ones for me here. Just on Abrysvo, just really quickly following up on the earlier commentary. Can you just update us on where we are in terms of contracting efforts and progress in the retail channel, just addressing some of the market share issues you highlighted last year? I guess my specific question is, do you have line of sight on contracting at this point? Or is that still something that's going to evolve as the year progresses?
這裡只有 2 個給我。就在 Abrysvo,只是快速跟進了先前的評論。您能否向我們介紹一下我們在合約工作和零售通路進展方面的進展,並解決您去年強調的一些市場份額問題?我想我的具體問題是,你現在對簽約有什麼想法嗎?或者說隨著時間的推移這仍會不斷發展嗎?
And then the second quick 1 was just on VYNDAQEL. Obviously very strong numbers. Maybe just a quick update in terms of where we are with penetration in that market. And where do we -- how much higher can this go? Just how much more of a growth runway is there for that drug?
然後第二個快速 1 只是關於 VYNDAQEL。顯然數字非常強勁。也許只是關於我們在該市場的滲透情況的快速更新。我們該怎麼做──這還能達到多高呢?這款藥物到底還有多大的成長空間?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Aamir?
阿米爾?
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Aamir Malik - Executive VP & Chief U.S. Commercial Officer
Thanks, Chris. So on Abrysvo, as I said, we're progressing our contracting conversations so we'll have more to share on that as we do later. And in terms of your question on VYNDA, VYNDA had a really strong quarter. We were up 96% year-over-year, but importantly, also 41% over last quarter. When you look at the drivers, I think there's a few things. Some of that is temporal. So there were some purchasing patterns with wholesaler and specialty pharmacies.
謝謝,克里斯。因此,關於 Abrysvo,正如我所說,我們正在推進合約談判,因此我們稍後會有更多內容可以分享。關於您關於 VYNDA 的問題,VYNDA 本季的表現非常強勁。我們的銷售額年增了 96%,但更重要的是,比上一季成長了 41%。當你觀察驅動因素時,我認為有幾件事。其中一些是暫時的。因此,批發商和專業藥局之間存在一些採購模式。
And we also made a lot of efforts towards the end of last year to ensure that the re-enrollment process for patients was very smooth at the beginning of this year. So all of that leads to a little bit of a Q1 bolus. But importantly at the heart of it, part of our strong performance on VYNDA is that the fundamentals around diagnosis and demand are really strong. So we saw a 33% quarter-over-quarter increase in new patient starts.
而且我們在去年年底也做了很多努力,確保今年年初患者的重新入組過程非常順利。所以所有這些都會導致 Q1 的少量增長。但最重要的,從本質上講,我們在 VYNDA 上的強勁表現部分在於圍繞診斷和需求的基本面非常強勁。因此,我們看到新患者數量較上季增加了 33%。
And diagnosis rates over the last several years, we had talked about getting into the 30% to 50% range. We're approaching the top end of that. And there is still significant opportunity to identify more patients. That's the biggest unmet need, and that's where we're concentrating our commercial efforts going forward. So we do think that we will sustain this momentum, probably not at the same rate that we saw in Q1 but we will continue to perform well with VYNDA.
過去幾年的診斷率我們一直在討論要達到 30% 到 50% 的範圍。我們正接近這個目標。並且仍然有很大的機會識別更多的患者。這是最大的未滿足需求,也是我們未來商業努力的重點。因此,我們確實認為我們將保持這種勢頭,儘管可能不會像第一季那樣保持相同的速度,但我們的 VYNDA 將繼續表現良好。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you. Alexandre, anything to add?
謝謝。亞歷山大,還有什麼要補充嗎?
Alexandre de Germay - Executive VP & Chief International Commercial Officer
Alexandre de Germay - Executive VP & Chief International Commercial Officer
Yes, very quickly. On the international front, we also had a very strong quarter because we saw a 28% operational growth but a 43% volume growth, which is comparable to what we see in the U.S. Exactly as Aamir said, there is still opportunity because we basically have established VYNDAQEL as the standard of care. And we've worked with the health care professional to establish robust infrastructure so that we can screen, diagnose, and treat faster.
是的,非常快。在國際方面,我們也度過了一個非常強勁的季度,因為我們看到營運成長了 28%,但銷量成長了 43%,這與我們在美國看到的情況相當。正如 Aamir 所說,仍然有機會,因為我們基本上已經將 VYNDAQEL 確立為護理標準。我們與醫療保健專業人士合作建立了強大的基礎設施,以便我們能夠更快地進行篩檢、診斷和治療。
And the reality is we still have opportunity to grow because, yes, in markets like France, we are talking 50%, but in other like Italy, we are around 30%, Japan, 28%. So there is still opportunity to grow and increase rates.
但事實上我們仍然有成長機會,因為在法國市場我們的成長幅度是 50%,但在義大利等其他市場我們的成長幅度約為 30%,日本為 28%。因此,仍有成長和提高利率的機會。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much. Next question. We'll take 2 more questions because we are running out of time.
非常感謝。下一個問題。由於時間不多了,我們還要再回答 2 個問題。
Operator
Operator
We'll take our next question from Tim Anderson with Wolfe Research.
我們將回答 Wolfe Research 的蒂姆安德森提出的下一個問題。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
So it's a busy pipeline readout year. I'm wondering, Mikael, can you just point to perhaps the 1 or 2 bigger upcoming readouts that excite you the most, where your confidence is high as that could be value creating? So I'm not looking for a description of everything reading out. Just maybe 1 or 2 that excites you the most.
因此,這是繁忙的管道讀數年。我想知道,邁克爾,你能否指出最讓你興奮的 1 到 2 個即將發布的重大數據,你對它們有很高的信心,因為它們可能會創造價值?所以我並不是在尋找所有內容的描述。也許只有 1 或 2 個最讓你興奮。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you. Mikael, excite us all.
謝謝。米凱爾,讓我們大家都興奮起來。
Mikael Dolsten - Chief Scientific Officer and President of Research & Development
Mikael Dolsten - Chief Scientific Officer and President of Research & Development
Yes, yes. I'm excited about the potential approval for marstacimab for both hemophilia A and B to continue to grow our hematology franchise momentum. DMD gene therapy, we actually today got the equivalent of Breakthrough Designation RMAT based on the early clinical data available, so we are super excited about that. And relatively near term, the readout is coming. COVID/flu combination vaccine, [859] readout Phase 3. And then one mid pipeline ponsegromab cachexia which I think pending readout has really a breakthrough mechanism.
是的,是的。我很高興馬斯塔西單抗可能獲得批准用於治療 A 型血友病和 B 型血友病,這將繼續增強我們的血液學特許經營勢頭。 DMD 基因療法,我們今天實際上根據現有的早期臨床數據獲得了相當於突破性認定 RMAT 的資格,因此我們對此感到非常興奮。而在相對較短的時間內,數據即將出來。 COVID/流感合併疫苗,[859] 讀數為第 3 期。然後是中期管道 ponsegromab 惡病質,我認為等待讀數確實有突破性的機制。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Anything from your side, Chris?
克里斯,你那邊有什麼消息嗎?
Chris Boshoff - Executive VP & Chief Oncology Officer
Chris Boshoff - Executive VP & Chief Oncology Officer
Perhaps just to mention again the potential unprecedented new 5-year data for Lorbrena, which will be presented oral at ASCO. We could define the growth of Lorbrena over the next decade. There's 2 other upcoming readouts.
也許只是再次提及 Lorbrena 潛在的前所未有的新 5 年數據,該數據將在 ASCO 上口頭呈現。我們可以預測未來十年 Lorbrena 的成長。還有另外 2 份即將發布的讀數。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
That's good if we are talking to that enthusiasm.
如果我們談論的是那種熱情,那就很好了。
Chris Boshoff - Executive VP & Chief Oncology Officer
Chris Boshoff - Executive VP & Chief Oncology Officer
And there's 2 other readouts that's important to us, the 1 is Breakwater, which is the first-line opportunity in BRAF-positive colorectal cancer. A reminder that, that's up to 12% of colorectal cancer. Particularly poor prognosis so we're looking forward to that readout, Breakwater and then also, as mentioned earlier, VERATEC 2 in second-line ER-positive breast cancer, which can define also the to define the future path for.
另外還有兩個對我們很重要的讀數,第一個是 Breakwater,這是 BRAF 陽性大腸直腸癌的第一線治療機會。需要提醒的是,這佔大腸直腸癌的 12%。預後特別差,因此我們期待該讀數,Breakwater,然後,正如前面提到的,VERATEC 2 在二線 ER 陽性乳腺癌中,這也可以確定未來的發展道路。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you very much.
非常感謝。
Operator
Operator
Our last question will come from Steve Scala with TD Cowen.
我們的最後一個問題來自 TD Cowen 的 Steve Scala。
Stephen Michael Scala - MD & Senior Research Analyst
Stephen Michael Scala - MD & Senior Research Analyst
I have 2 questions. In the Pfizer mRNA flu vaccine efficacy trial, was superior efficacy versus approved flu vaccine shown in the 65-plus cohort? This data was to have been presented last year but I don't believe we've ever gotten an update. And then secondly, your interest in obesity more broadly. So the outlook for danuglipron is not good. Bolt-ons don't look likely, but -- and this is just 1 very simple data point. There are postings on pfizer.com for obesity clinical lead position suggesting something is moving forward. So what exactly is moving forward in obesity at Pfizer?
我有兩個問題。在輝瑞 mRNA 流感疫苗有效性試驗中,在 65 歲以上的人群中是否顯示出比已批准的流感疫苗更優的有效性?這些數據本來應該在去年就公佈,但我認為我們至今尚未收到更新。其次,你對肥胖的興趣更為廣泛。因此,Danuglipron 的前景並不樂觀。附加裝置看起來不太可能,但是——這只是一個非常簡單的數據點。 pfizer.com 上發布的肥胖症臨床主管職位招聘資訊表明,相關工作正在取得進展。那麼輝瑞公司在肥胖領域的具體進展如何呢?
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Yes. On the obesity and Mikael also can comment, of course, together with the mRNA flu vaccine. But I said multiple times that first of all, metabolic is an area that we have traditionally very big strength in terms of, and this is an area that we have the right to win. So we are strong and to keep investing in the whole area because we have the infrastructure. And obesity is a very big part of it, even the of the market. So we will be very active in the obesity with current mechanism of actions and new mechanisms of actions.
是的。關於肥胖症,Mikael 當然也可以發表評論,同時也評論了 mRNA 流感疫苗。但我多次說過,首先,代謝領域是我們傳統上非常具有優勢的領域,也是我們有權贏得勝利的領域。因此我們很強大並且會繼續對整個地區進行投資,因為我們擁有基礎設施。肥胖是其中很重要的一部分,甚至佔了市場的很大一部分。因此,我們將積極利用現有的作用機制和新的作用機制來治療肥胖症。
We said repeatedly that we had 3 agents right now in the clinic, and we have multiple on the upper clinical that we are progressing. But we don't have anything to say per se right now because we are waiting, some data and on the other ones, it's too early to speak about them. So that's why we are not commenting much of that. And we will, let's say, continue being very active in the obesity space and one we're in now. Now what about the mRNA vaccine and anything you want to add also to the obesity line?
我們一再說過,我們目前在臨床上有 3 名藥物研發人員,而且我們還有多名藥物處於上層臨床階段,正在進行中。但目前我們沒有什麼可說的,因為我們正在等待一些數據,而對於其他數據,現在談論它們還為時過早。這就是為什麼我們不太評論這一點。我們可以繼續在肥胖領域以及我們現在所處的領域中非常活躍。現在,mRNA 疫苗怎麼樣?還有什麼您想添加到肥胖系列中嗎?
Mikael Dolsten - Chief Scientific Officer and President of Research & Development
Mikael Dolsten - Chief Scientific Officer and President of Research & Development
I think you said it so well on obesity. I'll focus on mRNA vaccine and just say that we did share that we had a very robust data for 18 to 59 in the outcome event trial on the first generation flu mRNA platform. We actually further refined that product in order to expand activity against these serotypes although the disease is dominated by A, we saw an opportunity to do that. And that technology is now with the COVID/flu combo vaccine running for 18 to 59 years old and relatively soon, we'll have a readout. We think that's really the near-term opportunity to bring both of the viruses under 1 simple administration approach. For the 65-plus, what you referred to was an early trial with the first generation. We have now moved focus to the second generation and are in preparation of subsequent clinical studies from them.
我認為你對肥胖問題的解釋非常好。我將重點介紹 mRNA 疫苗,我只想說,我們確實分享了在第一代流感 mRNA 平台的結果事件試驗中,我們擁有 18 至 59 年的非常可靠的數據。事實上,我們進一步改進了該產品,以擴大針對這些血清型的活性,儘管該疾病以 A 型為主,但我們看到了這樣做的機會。現在,該技術已與針對 18 至 59 歲人群的新冠/流感組合疫苗一起投入使用,並且很快我們就會得到結果。我們認為這確實是近期將兩種病毒納入簡單的管理方法的機會。對於 65 歲以上的人,您提到的是第一代產品的早期試驗。我們現在將重點轉移到第二代,並正在準備進行後續的臨床研究。
Albert Bourla - Chairman of the Board & CEO
Albert Bourla - Chairman of the Board & CEO
Thank you, Mikael. So thank you, operator, and thank you, everyone, for your interest. That was a very good call. In summary, we are very pleased with the solid start in 2024. We are cautiously optimistic about the year ahead. And with our continued progress in executing our 5 priorities, we are confident that we will continue to deliver for our patients, shareholders, and our company. Thank you again for your interest in Pfizer. We hope to have -- you have a wonderful day. Thank you.
謝謝你,米凱爾。所以謝謝接線員,也謝謝大家的關注。這是一個非常好的決定。總而言之,我們對 2024 年的良好開局感到非常高興。我們對未來一年持謹慎樂觀的態度。隨著我們在執行五大重點方面不斷取得進展,我們相信我們將繼續為我們的患者、股東和公司提供服務。再次感謝您對輝瑞的關注。我們希望—您度過美好的一天。謝謝。
Operator
Operator
This does conclude today's program. Thank you for your participation. You may disconnect at any time, and have a wonderful day.
今天的節目到此結束。感謝您的參與。您可以隨時斷開連接,祝您有美好的一天。