輝瑞 (PFE) 2024 Q1 法說會逐字稿

內容摘要

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。

完整原文

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

  • Operator

    Operator

  • Good day, everyone, and welcome to Pfizer's 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。我謹代表輝瑞團隊感謝您加入我們。此次電話會議透過 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,該新聞稿可在我們的網站 pfizer.com 上取得。

  • 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.

    今天我們的董事長兼執行長 Albert Bourla 博士也加入了我的行列。以及我們的財務長戴夫丹頓 (Dave Denton)。艾伯特和戴夫準備了一些發言,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學官 Chris Boshoff 博士; Alexandre de Germay,執行副總裁兼首席國際商務長; Mikael Dolsten 博士,首席科學長兼研發總裁; 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公認會計準則財務指標。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 SEC 文件中的披露,這些都可以在 pfizer.com 的 IR 網站上找到。電話會議中的前瞻性陳述存在重大風險和不確定性,僅在電話會議原始日期發表,我們不承擔更新或修改任何陳述的義務。

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

    這樣,我會將電話轉給艾伯特。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Thank you, 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。感謝您加入我們的通話。第一季度,我們今年有了一個良好的開局,我們對 2024 年將取得的成就持謹慎樂觀的態度。服務。這幫助我們在本季度的非新冠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先地位,推進了我們的產品線並繼續增強了我們的業務。

  • 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,我們將討論本季度的亮點,並提供有關我們如何繼續在年初與您一起服務的 5 個戰略重點方面取得進展的最新信息。我們為憑藉深厚的能力和全球規模在世界各地取得的正面影響感到自豪。今年前 3 個月,我們的藥物和疫苗已惠及超過 1.19 億名患者。我們將繼續發揚輝瑞 175 年推動醫療和製藥突破的歷史,最大限度地利用眼前的機會。

  • 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、商業和財務方面的成功。優先事項是:實現世界一流的腫瘤學領導地位,提供下一波管道創新,最大限度地提高新產品的性能,透過重新調整我們的成本基礎來擴大利潤,並分配資本以提高股東價值。在第一季度,我們在每個方面都取得了顯著的進展,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.

    你們中的許多人參加了我們二月份的腫瘤學創新日,我希望你們發現這是一個寶貴的機會,可以了解我們如何做好準備以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取得的卓越成就感到高興。

  • 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.

    新合併的團隊由輝瑞和 Seagen 的同事組成,我們相信我們擁有業內最有經驗、最有才華的腫瘤學領導者團隊之一。我們也已經看到了新的經過交叉訓練的銷售和現場醫療團隊強大的商業執行力所帶來的好處。

  • 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 Seagen—, —and 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,我們的腫瘤學收入比去年同期成長了 19%,部分原因是:從傳統 Seagen 收購了 4 種線上產品,尤其是在FDA 基於突破性的EV-302 數據批准後,無論順鉑金是否合格,PADCEV 都將繼續在一線局部晚期/轉移性尿路上皮癌中強力推出。

  • 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,它仍然是前列腺癌治療連續體的骨幹療法。我們的 LORBRENA 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治療標準。

  • 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 用於治療復發性或轉移性子宮頸癌。 TIVDAK 是第一個對先前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,我們的策略將重點放在為癌症患者帶來改變的最大機會。憑藉我們深厚的專業知識、廣泛多樣的產品組合和全球規模的力量,我們有信心朝著 2030 年將接受我們創新癌症藥物治療的患者數量增加一倍的目標邁進;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;預計生物製品收入比例將增加十倍。

  • 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。我們期待與您持續分享我們在加速腫瘤學突破方面所取得的進展。

  • 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 III study starts, including the first Phase III trial for our selective CDK4 inhibitor, atirmociclib; our integrin-beta-6-directed ADC, sigvotatug vedotin—; and the fourth Phase III trial for ELREXFIO in multiple myeloma.

    現在我將談談我們在下一波管道創新方面的進展。在腫瘤學領域,本季我們啟動了三項關鍵的 III 期研究,包括我們的選擇性 CDK4 抑制劑 atirmociclib 的第一個 III 期試驗;我們的整合素-β-6 定向 ADC,sigvotatug vedotin™;以及 ELREXFIO 治療多發性骨髓瘤的第四項 III 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 III 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 年無進展生存數據、瀰漫性大B 細胞中ADCETRIS 的III 期數據細胞淋巴瘤以及我們深入而多樣化的產品線中的其他進展。

  • 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.

    我們也推動腫瘤學以外的持續執行,重點關注預計將建立潛在的數十億美元產品組合的關鍵價值驅動因素。在第一季度,我們正在實現預期的里程碑,並在不斷增長的呼吸和血液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 III MONeT trial, evaluating ABRYSVO in adults aged 18 to 59 at increased risk for RSV disease.

    透過 ABRYSVO,我們相信我們有機會進一步擴大目前 RSV 疫苗批准的最廣泛患者範圍,包括 60 歲及以上的成人以及透過母體免疫接種的出生至 6 個月的嬰兒。我們最近報告了 III 期 MONeT 試驗的正面結果,該試驗在 18 至 59 歲 RSV 疾病風險增加的成年人中評估了 ABRYSVO。

  • 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,我們有信心能夠在血友病和鐮狀細胞病領域建立一個潛在的數十億美元的產品組合。我們最近獲得了美國 FDA 對輝瑞的第一個基因治療批准,以及 BEQVEZ 的 FDA 批准,BEQVEZ 是一種針對成人 B 型血友病的一次性基因治療。

  • 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.

    該計劃建立在我們不斷擴大的血友病治療基礎之上。我們預計FDA 會在年底前對marstacimab 做出決定,該藥物有可能成為B 型血友病市場上第一個每週一次的皮下注射治療藥物,也是第一個針對A 型血友病和B 型血友病以固定劑量提供的治療方法。

  • Moving to sickle cell. We recently started the Phase III 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 osivelotor 的 III 期研究,osivelotor 是我們潛在的同類最佳的下一代血紅蛋白 S 聚合抑制劑。我們致力於滿足鐮狀細胞疾病社區服務不足的需求,並且我們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:最大限度地提高新產品的效能。雖然可能需要一年的時間才能充分認識到我們所實施的變革的全部好處,正如我們所說,為我們的商業運營帶來更高效​​的結構,但我們對我們已經從我們的銳化重點和輝瑞公司看到的影響感到高興同事們擁抱我們的高績效文化。

  • 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.

    早些時候,我提到了我們腫瘤產品的動力。我們的輝瑞美國商業和輝瑞國際商業組織也在推動各自市場的成長中不斷前進。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 a’re encouraged by our opportunities to continue increasing overall RSV market growth and market share.

    憑藉 ABRYSVO,我們對 18 至 59 歲年齡組的積極數據感到非常滿意,這使我們的產品脫穎而出,並且我們對繼續提高 RSV 市場整體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 幫助全球超過 10 億偏頭痛患者的潛力充滿熱情。由於口服 CGRP 滲透率有潛在顯著增長的空間,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准入障礙,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 annual (sic) [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制定為慢性和主動治療,主動治療鐮狀細胞疾病的根本原因的重要性。 VELSIPITY 即將完成其年度(原文如此)[首次]發布,我們致力於確保患者能夠將其作為中度至重度潰瘍性結腸炎的一線先進治療口服選擇。

  • 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.

    我要提到 LITFULO。我們將努力繼續加快考慮對適當的斑禿患者進行先進的系統治療,並進一步解鎖 LITFULO 的使用權。此外,我們繼續保護和發展我們的核心品牌和關鍵重磅產品,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,戴夫將提供有關我們如何在其他兩個戰略重點方面取得進展的最新信息,即通過重新調整成本基礎來擴大利潤以及分配資本以提高股東價值。當我們考慮第一季所取得的成就以及在執行 5 個策略重點方面的持續進展時,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的開端。隨著我們在推進成本調整計劃方面取得的進展,以及我們對業務的潛在優勢和持續執行力的信心,我們將 2024 年調整後每股收益的預期上調了 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.

    我們對我們的公司充滿信心。我們擁有業內一些最有經驗、最有才華的同事,之前多次證明我們非常擅長執行,我們期望繼續為全球數億患者提供改變生活的藥物,並為我們的股東創造有意義的價值。

  • Now, I wi’ll 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,我將把它交給戴夫,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取得的進展。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,艾伯特,早安。在我們繼續應對充滿挑戰的新冠疫情后環境之際,我很高興地告訴大家,今年已經有了一個好的開始。我們正在保護和發展我們的核心品牌,同時投資建立更有效率的組織。我們對執行的不懈關注使輝瑞能夠提高股東回報。

  • 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.

    今天早上,我將簡要回顧我們第一季業績的亮點,然後我將談談我們的資本配置優先事項。最後,我將概述我們的 2024 年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.

    轉向第一季度,讓我來看看損益表。該季度公司總營收為 149 億美元,營運收入較去年下降 35 億美元,成長 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,我們預計今年新冠病毒產品將繼續對我們的營收和利潤產生巨大影響。

  • 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.

    然而,我確實想指出,我們預計我們的新冠產品在可預見的未來將繼續為收入和現金流做出貢獻。如果排除 COMIRNATY 和 PAXLOVID,整個企業強大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.

    我們重新聚焦重點產品和市場,精細化全球商業領域資源配置,進一步將行銷資源投向重點領域,對績效產生了正面影響。我們從 Seagen 購買的產品以及 VYNDAQEL、ELIQIS 和 ABRYSVO 等系列產品對此表現做出了貢獻。

  • 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.

    預計全球對 IBRANCE 和 SULPERAZON 的需求下降,抑制了我們本季的成長,這主要是由於 2024 年第一季中國需求較去年下降。

  • 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比去年第一季提高了 530 個基點,達到 79.6%。這項改進是由 3 個因素推動的。首先是 COMIRNATY 銷售量下降,導致銷售組合有利。其次,在本季度,我們記錄了與我們的美國政府合約相關的 PAXLOVID 產品退貨調整,我稍後會談到這一點。

  • 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,我們在整個製造網路中執行了強而有力的成本管理。毛利率的提高將繼續成為公司未來的重要關注點。儘管增加了與收購的 Seagen 業務相關的費用,但與去年第一季相比,調整後營運費用總額小幅增加 1%,達到 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能夠在年底前兌現 40 億美元的淨節約承諾。由於最近收購或推出的產品的營銷和促銷費用增加,本季度調整後的 SI&A 費用在營運上增長了 3%,但部分被 PAXLOVID 和 COMIRNATY 費用的減少所抵消。

  • 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,同時支持我們管道的成長。本季度,調整後的研發費用為 25 億美元,營運費用比 LY 下降 1%。略有下降的主要原因是我們的成本調整計劃導致支出減少以及某些疫苗項目支出減少,但主要被主要用於開發從 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.

    第一季攤薄每股收益為 0.55 美元。我們的調整後攤薄每股收益為 0.82 美元,由於良好的毛利率表現以及整個企業強有力的成本管理,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 PAXLOVID 的美國政府合約相關的有利產品回報調整。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,美國政府宣布不再授權 CU 使用 EUA 標籤產品,且商定的退貨期限現已到期。鑑於這些事實,我們現在可以最終確定美國政府信貸的總價值。這導致 PAXLOVID 的收入調整為 7.71 億美元,並為該公司每股收益貢獻了 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.

    現在讓我快速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,以及在資產負債表去槓桿化後進行增值股票回購。

  • 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 24 億美元,在內部研發方面投資 25 億美元,正如預期的那樣,本季的業務開發活動很少。我們致力於實現總槓桿率目標為 3.25 倍的資本結構,我們預計隨著時間的推移將實現這一目標。

  • 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%.

    為了支持這一目標,本季我們償還了約 12.5 億美元的到期債務。 5 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,這將我們在該公司的股權從 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.

    展望未來幾個季度,我想指出,我們預計營運現金流將大大低於典型水平,這主要是由於某些付款的時間表。儘管存在短期壓力,但顯然我們的目標是隨著時間的推移恢復更加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.

    現在讓我花幾分鐘談談我們對今年剩餘時間的展望。進入 2024 年,公司高度重視兌現其財務承諾,第一季的業績表明我們有了一個良好的開始。考慮到這一目標,而且現在還處於今年年初,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.

    我們將全年調整後稀釋每股盈餘指引範圍提高 0.10 美元,達到 2.15 美元至 2.35 美元的新範圍。展望未來,這一成長既考慮到我們對成本節約目標的視野的改善,也考慮到我們基礎業務的持續實力。提醒一下,我們的 EPS 指導還包括預計因收購 Seagen 而導致的 0.40 美元的收益稀釋,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收入指引範圍的上限,但我們今年的營收預期保持不變。我們仍然預計收入在 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,我們預計大約 90% 的銷售額將發生在今年下半年,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 億美元的淨節省。改善我們的成本基礎將為我們在前進過程中為擴大利潤率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,在過去兩年中,該公司進行了大量投資以推動本世紀後半葉的成長,我們仍然對輝瑞的長期成長前景感到鼓舞。 2024 年顯然是我們重點關注、執行和兌現近期財務承諾的一年。我們今年建立的基礎為我們在今年和本世紀末兌現提高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.

    說到這裡,我想在我們開始問答環節時將其轉回給阿爾伯特。

  • 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,請整理隊列。

  • Operator

    Operator

  • (Operator Instructions) We'll take our first question from Louise Chen with Cantor.

    (操作員說明)我們將回答 Louise Chen 和 Cantor 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 RSV 疫苗銷售的問題。只是好奇是什麼導致了第四季的下滑。看來葛蘭素史克也有類似的下滑。那麼您如何看待疫苗和治療市場上潛在的競爭?這會影響您對該系列未來的成長預測嗎?

  • 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,這是你的問題,那麼也許亞歷山大也可以補充,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 疫苗市場似乎遵循季節性趨勢,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,我們看到的市場是針對老年人的,它在本季中肯定有所減弱。因此,在一月份的第二週出現了峰值,然後此後逐週穩定下降。

  • 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,出於多種原因,我們在秋季處於有利的位置。

  • 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合約。其次,我們在非零售通路擁有真正的實力。你提到了葛蘭素史克。他們報告了他們的收入。當您查看報告中的美國收入組合時,您會發現大約是 60-40 的比例。我們的零售份額低於此,但我們的非零售份額要高得多。從第四季度到第一季度,我們的這部分業務確實翻了一番,從 9% 左右增加到 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.

    我認為這恰恰說明了我們在醫生辦公室的實力以及我們與有組織的客戶的關係。我還要指出的是,今年晚些時候,如果獲得批准,我們將有ACT-O-VIAL 的新介紹,它展示了管理的簡便性,以及我們的臨床數據,阿爾伯特在他的演講中提到了標籤擴展ABRYSVO 適合 18 至 59 歲的人群以及 - 有風險的人群以及 2 個季節的持久功效。我認為這些商業努力以及潛在的品牌擴張的結合確實為我們在秋季做好了準備。

  • 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。路易絲,謝謝你的提問。在國際方面,我們實際上在ABRYSVO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。感染,如RSV,以及透過在所有其他疫苗接種後對母親進行免疫接種。所以我們正在取得良好進展。

  • 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.

    事實上,我們已經收到了英國、澳洲、挪威的建議,我們正在取得進展並等待許多其他歐洲市場疫苗技術委員會的一些建議。從監管角度來看,我們也取得了良好進展,因為在第一季日本和沙烏地阿拉伯王國的孕產婦免疫接種期間批准老年人和心肌梗塞是一個里程碑。

  • 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數據,因為獲得 VTC 的批准並為這些活動獲得資金需要時間,但我們看到了解決國際上未滿足的醫療需求的重大機會。舉個例子,例如在歐洲,出生第一年因呼吸道感染住院的一半是RSV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.

    所以這絕對是一個絕佳的機會。大多數住院治療發生在出生後的前 3 個月。如您所知,ABRYSVO 是唯一有助於保護嬰兒從出生到 6 個月期間免受 RSV 免疫引起的下呼吸道感染的孕產婦疫苗。所以我們看到了一個很好的機會。

  • 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.

    我們將回答摩根士丹利特倫斯·弗林的下一個問題。

  • 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?

    也許只是我的兩個部分。只是想知道您是否可以評論一下 D 部分重新設計對 2025 年的潛在影響。我們已經聽到其他幾家公司已經在這裡發表評論。然後是管道上的一個。您能為我們提供有關 danuglipron 的最新資訊以及您在肥胖方面更廣泛的計劃嗎?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Yes, thank you. Can you (inaudible)? 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。你可以嗎(聽不清楚)?讓我拿那個來掃清道路。這並不新鮮。我們沒有關於達努的消息。一切都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配方相關的全部數據。然後根據數據和其他一切,我們將決定未來的計劃。因此,當我們有更多要說的時候,我們會談論它們。不過,現在讓我們向 Aamir 詢問 2025 年 D 部分的重新設計。

  • 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。正如您可以想像的那樣,D 部分需要重新設計許多活動部分。我認為與我們的業務相關,我認為首先要注意的是,作為重新設計已經到位的一部分,疫苗沒有分攤成本。因此,考慮到我們重要的疫苗組合,這是一個積極的因素。然後,顯然,在 24 年和 25 年期間,自付費用上限還有其他動態,這為患者創造了更好的獲取機會,這有助於增加數量,我們開始在'24 我們業務的某些部分,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.

    然後還有一些事情即將發生,包括上限的改變以及耐心的平滑。所以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。因此,我們正在密切追蹤這一切是如何實施的。我們不會就 2025 年對我們業務的直接美元影響提供任何具體指導,因為這方面還有很多工作要做。當我們準備好這樣做時,我們當然會這樣做。

  • Operator

    Operator

  • We'll take our next question from Akash Tewari with Jefferies.

    我們將接受 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 CGM become accretive to Pfizer earnings by next year?

    在 tafamidis 方面,季度表現非常強勁,但我想詢問專利壽命。鑑於我們已經看到歐盟專利局減記了多項無效異議,而在美國方面,被告似乎承認了侵權。我們該如何考慮這個產品的智慧財產權?為什麼這項專利不適合到 2025 年?第二,PADCEV 的季度表現非常強勁,一線子宮頸癌藥物 TIVDAK 即將上市。到明年我們是否有可能看到 CGM 為輝瑞公司帶來收益成長?

  • 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.

    這是非常好的問題。為什麼我們不先去找你,戴夫,談談做得很好的事情。如果您期望這可以更早增值。另外,我想聽聽 Chris 關於產品組合進展的一些評論,然後 Doug 可以對我們的客戶的智慧財產權發表評論。

  • 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 顯然是一個非常穩健的季度,也是一個非常穩健的今年開局。我認為我們不會改變對 Seagen 的短期和長期期望,但我認為我們在展望未來時持謹慎樂觀的態度。因此,除了我們對已經建立的財務指標的持續承諾之外,可能沒有什麼需要更新的財務資訊。再說一次,我們可能對該業務目前所看到的潛在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,您還想對 Seagen 業務的業績發表一些評論嗎?

  • 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,我想補充戴夫所說的,正如他指出的那樣,302 還處於早期階段,數據是——我們今年年初剛剛推出。我們已經看到了 164% 的同比預計增長。雖然還為時過早,但我們很高興收到了 NCCN 指南類別 1。我們在學術和社區環境中都得到了採用。事實上,目前 70% 的帳戶都在社區上。我們現在正在展望未來,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 年晚些時候、'26、'27 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?

    非常感謝你,克里斯。 Doug,知識產權糾紛的情況如何?

  • 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。抱歉,VYNDAQEL 和 VYNDAMAX 目前擁有美國專利獨佔權,有效期到今年年底。但我們有一項專利正在等待專利期限延期,該期限將延長至 2028 年 12 月。在歐洲主要市場,我們的專利將於 2026 年 11 月到期。

  • 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,本季取得了不錯的進步。我相信,早在 12 月份,您就曾說過,全年的成長率將在 70% 左右。考慮到我們已經看到的好處,您是否認為我們全年實際上可以看到更好的毛利率?或者還有其他一些我們應該注意的看跌期權和拿取期權嗎?

  • 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。我們一直致力於從毛利率和經營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。其中一些是更持久的。我認為我們的毛利率表現中令人鼓舞的是我們整個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 卷是非常後半加權的。如您所知,COMIRNATY 之所以能夠獲利,是因為我們的利潤份額的毛利率非常低。因此,這種組合將在今年下半年逆轉,壓縮並給我們的毛利率帶來壓力。因此,隨著該產品在 2024 年發揮作用,這種動態應該會發生。

  • 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.

    我們將接受古根漢證券公司的瓦米爾·迪萬 (Vamil Divan) 提出的下一個問題。

  • 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。我想簡單談談這兩種產品的新成長動力。 NURTEC 就是其中之一,它比我們預期的要輕。顯然,第一季的毛淨值往往受到很大影響。我只是想了解您是否可以提供更多有關本季度動態以及您對該產品前景的預期的任何變化的詳細資訊。

  • 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,ELREXFIO。剛剛注意到您的幻燈片簡報中曾經列出了前幾季的關鍵成長動力。今年,在投影片 9 上,您的關鍵成長動力不再列出。所以我只是好奇這是否是一個有意的改變。我只是很好奇,是什麼促使我們決定將其從關鍵成長驅動因素中剔除?

  • 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.

    非常感謝你,瓦米爾。 Aamir,NURTEC,然後是 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。所以我很高興能談談 NURTEC。我們希望加速 NURTEC 的發展勢頭,我們正在採取幾個步驟來實現這一目標。就本季本身而言,我們看到的需求和數量令我們感到鼓舞。另一方面,正如您已經提到的,本季的業績受到毛淨值的影響。

  • 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,請記住以下幾點。 NURTEC 繼續保持其在同類產品中的市場領先地位,TRx 份額為 49%,比去年第一季增長了 28%。其次,我們密切關注的 NBRx 份額,整體交易量達到了自我們於 22 年底完成 Biohaven 收購以來的最高點。

  • 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,這一數字比去年有所上升,但更重要的是,比 23 年第四季有所上升。第一季約有 11,000 名 NURTEC 新作者,佔 CGRP 口語班所有新作者的 90%。因此,我們受到許多關於數量和需求的鼓勵。

  • 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.

    從毛額到淨值來看,本季有 3 個問題。一個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,只是考慮到效益設計動態。其次,本季我們確實在政府和商業管道之間存在一些付款人混合問題。最後,我們的 GTN 在第一季進行了一次不利的前期調整。

  • 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.

    你關於今年剩餘時間的問題,對於 NURTEC,我們預計將持續成長。我們已經討論過這樣一個事實:未經治療的患者和治療不足的患者的基本面仍然強勁。我們也認為,我所描述的一些淨收入總額將是暫時的,並將在今年剩餘時間內慢慢減少。然後,我們在商業執行方面做出了一些改變,包括患者參與方面的工作,以不同的方式將我們的現場人員資源集中在醫生意識上,並努力減少患者訪問的摩擦。因此,總體而言,我們確實預計 NURTEC 在 2024 年剩餘的時間內將繼續成長。

  • 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 嗎?

  • 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,艾伯特。因此,Albert 之所以沒有將 ELREXFIO 列為主要成長動力,只是為了提醒一下,所以他指出 LORBRENA、XTANDI 和 PADCEV 是腫瘤學的直接最大成長動力。但我們絕對相信 ELREXFIO 將在未來幾個月和幾年內成為腫瘤學的主要動力。

  • 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.

    提醒一下,我們已經在高度難治性患者群體中看到了非常有希望的療效數據,並產生了深度和持久的反應。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,現在我們要認識到,由於沒有面對面的研究,因此還沒有明確的結論。目前,我們對所看到的吸收情況感到鼓舞,隨著我們計劃的新患者開始建立。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 III 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.

    並提醒您,我們將在未來 12 個月內進行 4 項註冊研究。第一個 III 期研究將在 MM5 研究中讀出多個結果。我們最近也收到了用於存取的 J 代碼,我們正在簡化報銷流程,並繼續在各種途徑(甚至在某些途徑中是最有利的途徑)中獲得有利地位。我們期待盡快向您通報更多有關 ELREXFIO 的資訊。

  • 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,您對國際市場上的產品有什麼要補充的嗎?

  • 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。在ELREXFIO 上,我們實際上進展非常順利,因為如您所知,我們於2023 年12 月在歐洲獲得批准,於1 月在英國獲得批准,於2024 年3 月在日本獲得批准。進入報銷階段,ABRYSVO 。考慮到該產品的臨床概況和卓越的臨床概況,我們已經獲得了早期訪問權限。這就是為什麼我們在某些​​市場獲得了早期訪問權,這就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.

    但我們對此感到非常滿意。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,我們實際上確實獲得了一流的認可。因此,我們將在今年稍後進行註冊——報銷討論和產品介紹。

  • 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。總體而言,在大多數國際市場中,批准與准入之間存在差距。但由於產品的概況,我們看到了早期訪問,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。但有些國家在批准價格之前,允許您了解自己的價格,並且可能會進行調整。所以——但是這個產品有一個非常好的跡象。當我們看到臨床概況和關鍵意見領袖的觀點時,我們真的感到非常樂觀。

  • 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。那我可以問多少問題呢?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • You, Dave, you don't have a limit.

    你,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。我只是想了解它是否在第一季觸底,或者是否在 3 月 30 日之後進一步削減成本,從而使公司的成本結構在第一季之後下降。其次是 VYNDAQEL。我很欣賞之前回答問題的評論,但我只是想更好地理解如何思考它。

  • 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,有評論稱專利期限可能會延長至 2028 年 12 月之後。那麼,如果輝瑞(Pfizer)成功,那麼對美國來說,日期會是哪一天而不是 12 月 28 日?然後對於歐盟,評論是 26 年 11 月。但我聽說歐盟專利發展取得了積極進展,我正在努力了解這會將歐盟擴展到什麼領域。

  • 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.

    非常感謝你,戴夫。戴夫丹頓(Dave Denton),請您考慮成本結構。

  • 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,如您所知,調整我們的成本結構對我們來說非常重要,因為我們考慮未來利潤率擴張並提高我們的財務回報。當我們回顧第一季和今年剩餘時間時,請記住,我們在美國所做的成本變化已基本完成。顯然,在美國以外的地區,其中一些變化是滯後的,但您會看到今年剩餘時間美國以外的成本結構發生變化。

  • 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,這些可能沒有我們預期的那麼大。但我只想說,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焦點。現在,我們正在不斷思考如何投資以及支持我們未來業務收入目標的適當成本結構是什麼。

  • 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。 Doug,您能否針對 Dave Risinger 的問題澄清一些有關 VYNDAQEL 的事情?

  • 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。需要先明確的是,Dave,我們不應該在 2028 年 12 月之後考慮 VYNDAQEL 和 VYNDAMAX。因此,我們已提交並正在等待專利期限延期。我想說的是,除了我們提交並正在審理中的專利期限延長(將其延長至 2028 年 12 月)外,我們可能會再次提交額外的專利期限延長,只是將其延長至 12 月2028 年。我希望這一點很清楚。

  • 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.

    我們將回答瑞銀的 Trung Huynh 提出的下一個問題。

  • 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 (UBS) 的 Trung Huynh。一個關於即將舉行的 ACIP 會議的信息,如果可以的話,我只是對指南進行澄清。那麼在 6 月的 ACIP 上,您對 50 至 59 歲人口的建議有何期望?這是否可以像 60 歲以上的人一樣做出共同的臨床決定?您認為這將是基於風險的嗎?您是否有機會獲得本次會議議程上的18至59號資料?

  • 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,這裡對本季的功勞進行了澄清,因為您保留了 PAX 的 30 億美元指南。我很欣賞您現在將位於指南上端的評論。但在 PAX 上,考慮到您更新了 EPS 指南,您預計 PAX 銷售額會比年初想像的少 7.7 億美元嗎?或者這是預料之中的?

  • 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,也許我會先接受。從指南的角度來看,我不會——我們顯然沒有預料到這次的最終調整。這是我們在年底時所做的估計。我們現在正在根據我們所看到的回報來完成調整,現在已經完成。我想說的是,當我們展望全年時,無論是 PAXLOVID 還是我們所有產品的全年,我們對我們的現狀持謹慎樂觀的態度。

  • 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 是從非常可靠的利用開始的。請記住,該產品的趨勢將與全球感染率一致。我們仍然對實現我們的目標持謹慎樂觀的態度,我們目前的預期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。

  • 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 年間將獲得大量積極且資訊豐富的數據。並且即將在美國 FDA 進行備案。我們還有第二季的數據、完整的第二季以及迄今為止可用的數據,這些數據對我們來說顯示出強勁且可能是同類最佳的數據。您聽到 AAMIR 提到過,我們還有新的交付格式。因此,發生了很多積極的事情來進一步加強 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.

    對於建議的正式決定,ACIP 通常要等到產品獲得 FDA 批准後才會做出。我們不知道 FDA 何時會批准。顯然,我們認為,考慮到這個獨特的年齡範圍,它可能對秋季有意義,但這當然需要等待 FDA 的意見。但我們肯定會非常開放地分享其中幾個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,並且在某種意義上具有積極的獨特性。謝謝。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Internal 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, do ll do what they can to 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.

    對於這兩個問題,內部有一些評論。關於ACIP,我們始終不為ACIP說話。所以這是不合適的,我們會盡力而為。當然,正如我們所說,通常他們會等待 FDA 的批准,我們希望他們會要求我們在 6 月提供數據,但這是我們不知道的事情。我們所知道的是,無論他們做出什麼決定,無論何時,我們都會在美國準備好我們的行銷和商業計劃,當然,就像我們在其他國家所做的那樣,以便我們能夠最大限度地獲得我們所擁有的批准、建議或數據。所以這是一件事。

  • 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.

    大衛解釋說,另一件事我們當然持謹慎樂觀的態度——這貫穿​​我們提供的整個指導方針中。我們對收入持謹慎態度,對利潤率也持謹慎態度。當然,我們再次謹慎地提高了每股收益。你需要從去年去過那裡的人的角度來看待所有這一切,我們對新冠病毒的預期和最終發生的情況之間存在很大的偏差。

  • 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 b safe. So that as a context to all the guidance that we have provided this time.

    這讓我們在談論預測時要加倍謹慎。我們知道信譽對我們來說極為重要。因此,我們所說的一切都感覺火箭般堅實,但我們一定會實現。我們僅此而已,我們更喜歡實現而不是安全。因此,這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.

    我們將接受 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,我想問幾個財務方面的問題。首先是毛利率。戴夫,我記得上次您提到了兩件具體的事情:最近收購的產品的內包以及新產品的推出會拖累毛利率。考慮到這兩件事可能都被納入第一季度,而且第一季看起來更像是歷史利潤率建設所暗示的那樣,這是否表明全年利潤率正在明顯高於全年指導值 70%?或者是否有一些一次性的事情,例如第一季最近收購的一些庫存工作減少了,這對其有所幫助?

  • 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,也許這對你和艾伯特來說都是如此。考慮到更廣泛的環境和一些關於股息的問題,多年來你們的一些過剩製造能力是否有可能顯著貨幣化,無論是填充完成還是以後?

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • I think David can take both of them. Dave?

    我認為大衛可以把他們兩個都帶走。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有利的影響。您列出的新產品發布和內購項目,內購可能對我們有長期影響,因為這些不會在短期內發生。因此,當您想到 Seagen 時,您會發現這可能是我們這裡存在的多年現象。但我認為這對此沒有太大影響。

  • 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,新產品的推出,我們計劃壓縮我們的毛利率,而他們確實做到了。我認為我們已經有了一個非常堅實的開始。但請記住我之前所說的,今年下半年,COMIRNATY 的銷售額將開始上升。考慮到我們向合作夥伴提供的合作夥伴貢獻和付款,他們相當顯著地壓縮了我們的毛利率。因此,我預計這將削弱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.

    Umer,如你所知,如果可以的話,我們專注於超額交付。因此,我認為我們將盡一切努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,首先也是最重要的,我只想重申,從資本配置的角度來看,我們的第一要務是隨著時間的推移支持和增加我們的股息,而且這沒有風險。其次,是的,我們總是專注於我們在平台上擁有的資產,並了解利用這些資產的最佳方法是什麼,其中一些可能是將其中的一些資產貨幣化。其中一些可能會更有效地運作。所以從這個角度來看,一切都擺在桌面上。

  • 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,但我只會重申您所說的內容,因為似乎有些人想再次聽到它。股息對我們來說是神聖的。股利是有保障的,我們將繼續我們所承諾的股利政策。我們不必將事物貨幣化才能看到這一點。我們之所以關注所有資產,是因為我們希望資本回報能最大化。

  • 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。我不知道什麼時候有意義,就像我們所描述的那樣,人們希望獲得的無菌能力現在有嚴重的問題。我們會考慮一切,但我們現在關注的並不是這個或那個,因為我們需要支持股息,所有這些實際上都是為了支持去槓桿化機會或需要支持業務投資,對吧?我們不需要做任何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?

    只要有2個快速的。第一個是現在 Seagen 已經完全整合,您將從交易中看到一些商業槓桿,您是否期望看到對 PADCEV 等的更多漸進影響,以及未來幾年的發展軌跡?或者你能有更近期的改變嗎?然後第二個問題,戴夫或阿爾伯特,對股息的資本配置承諾非常明確。我們在投影片 12 上認為股息和去槓桿化是兩個最重要的優先事項,或者補充 BD 是否仍在今年或明年的組合中?

  • 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。讓我們向 Chris 了解對 Seagen 的商業影響以及這需要時間。

  • 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,我們在關閉之前進行了數月的計劃,以確保我們實現無縫整合。我們在一月份完成了商業現場團隊的交叉培訓,特別是 TUKYSA 和 IBRANCE 之間的乳癌培訓,以及 ADCETRIS 和 ELREXFIO 之間的血液學培訓。我們應該開始看到這種情況在未來幾個月進一步發展。

  • 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,我們顯然非常高興看到大量的同事保留,因此在我們建立新業務時,無論是來自舊輝瑞還是舊 Seagen 組織,我們都沒有遇到保留同事的問題。

  • 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 將繼續表現出色。由於突破性的數據使總生存率翻倍,醫療保健提供者、患者和患者倡導團體都表現出了極大的熱情。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 III study with an NME from the Seagen portfolio with a secret attack. and we hope to update you on other Phase III studies from the legacy Seagen portfolio.

    例如,我們也看到 TUKYSA 預計將年增 21%。事實上,上個季度是 TUKYSA 業績最高的一個季度。總的來說,我們充滿信心,我們透過 Seagen 產品組合中的 NME 進行了第一個新的 III 期研究,並進行了秘密攻擊。我們希望向您通報 Seagen 遺留產品組合中其他 III 期研究的最新情況。

  • 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 III on starts.

    從我的角度來看,是的,當然,我們在這項業務上投入了大量資金,我們認為這是一個我們可以為世界帶來巨大改變的領域。我正在非常密切地監視這一情況。事實上,我想說的是,我很驚訝在積極的一面,第一天加 1 對輝瑞的影響是 3 而不是 2。許多第三階段。

  • 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.

    你看不到,但我對早期階段發生的事情有很高的了解,我們在診所投入了很多東西。然後在廣告中,您現在可以看到輝瑞方面 IBRANCE 的穩定,然後種子和資產的高速增長,儘管事實上,正如我所說,您應該預計前 6 個月會出現下降。

  • 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,我們總是會遇到衰退。我還沒有看到我們做過任何整合,但它沒有面臨挑戰,因為人們正在改變領域,人們正在改變,比如說,工作、行銷人員正在四處流動。

  • 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.

    可以說,所有這些都在這裡造成了破壞。我們可以—我們雙方都有非常非常強勁的成長。所以我真的非常非常高興。當然不是,需要時間才能看到全部好處。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,由於這與您有關資本配置的問題有關,顯然,我們的首要任務是支持股息以及去槓桿化我們的資產負債表。從我的角度來看,這就是工作 1。由於它與補強收購有關,因此在短期內,您不會指望我們在那裡做太多事情。在我們找到自己之前,這在短期內是一個較低的優先事項。我希望這有幫助。

  • 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.

    我們將接受 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 III trials, like whether it's CDK4/6 combo or CDK4 combo or both of them?

    祝賀取得的進展。我從 IBRANCE 的角度有一個關於您的乳癌特許經營權的問題。您獲得了來自雌激素受體 PROTAC 的關鍵數據,預計將於今年稍後與 Arvinas 合作。一是,您對這些數據有何期望?這些數據對於您做出繼續或啟動組合 III 期試驗(例如是 CDK4/6 組合還是 CDK4 組合或兩者)的決定有多重要?

  • 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。非常感謝你的提問。謹提醒您,IBRANCE 目前全球已有超過 773,000 名患者接受了 IBRANCE 治療。所以目前還是CDK4/6的領導者。我們對 2 個項目感到非常興奮:vepdegestrant,我們認為它是同類最佳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.

    因為,正如您所指出的,我們將在今年稍後獲得 VERITAC-2 的數據,但我們正計劃在羅仕證券進行更多研究。您可以期待看到一線研究,包括 atimociclib 和標準護理內分泌治療以及 termocyclib+ 品牌的一線研究。 (聽不清楚)正如您在經過大量預處理的人群中所看到的那樣,我們看到總體緩解率為 32%,中等進展生存期為 8.1 個月。因此,我們深受鼓舞。

  • 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.

    我絕對對安全性感到非常鼓舞,我們看到CDK4 更連續的給藥、非常好的合規性和更完整的覆蓋,這就是為什麼我們有信心將CDK4 加速納入註冊策略,並且第一項研究已經開始,因為你知道,二線研究。

  • 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卡特古爾德的下一個問題。

  • 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?

    我想詢問後續情況,因為我認為這很重要,並且我完全尊重對 '24 的關注以及阿爾伯特對圍繞指導的保守主義的評論。但回到 IRA 的影響來思考 25 年。您認為什麼時候您才能更好地對您的合約討論進行評論,這裡的收益季節已經很晚了,而且您的大多數同行已經發表了評論,而您的 D 部分風險還沒有真是一個驚喜。所以時間線上的任何顏色都會有幫助。我想對大衛來說,你談到營業利潤率的提升是一個多年的過程。 IRA 是否有可能在 25 年出現一些小問題?

  • 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,你對此有何評論?

  • 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,我們將更清楚地了解這意味著什麼。所以我們當然可以分享這一點。我認為還有一個關於 Eliquis 的經常出現的具體問題,所以讓我現在就解決這個問題,因為我們顯然正在就這個問題進行即時談判。

  • 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 正在引領這一進程。您已經聽過他們的描述,我們也描述了 26 年 9 月時間範圍內的影響結果將是透明的。到那時,我們將能夠分享更多。

  • 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,由於它與 2025 年以及從利潤擴張的角度來看 IRA 的影響有關,我想說的是,在我們展望未來的情況下,我們顯然會圍繞我們的業務表現運行多種場景。在這些情況下,我們將對愛爾蘭共和軍的不同影響進行建模,因為它仍然不清楚,因為它仍然有很多變化的部分,特別是正如我們剛才談到的。在這些情況下,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.

    我想談一下愛爾蘭共和軍,而且我們也說過一些話,但很明顯,到 2025 年,我們將發生兩件事,我們必須為製藥行業做出貢獻,所以這將把比如說,定價壓力。而且,由於自付費用的動態帶來了巨大的痛苦,我希望這將像法律所說的那樣立即實施,因為我聽到了嘗試解決這一問題的努力。

  • 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,我們確信這一點,因為這是法律,我們將看到大量吸毒,對吧,對每個人來說,不是我們,當然,對每個人來說,因為在監獄裡發生了大量的遺棄事件。很高了。

  • 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.

    因此,我認為,動態的,你知道,只要患者支付的費用較少,該行業總是要求我們為自付費用做出貢獻,因為這對所有人都有顯著的好處:對於醫療保健系統,對於患者,對於我們。所以我並不擔心整個產業的狀況。我非常擔心整個產業強制降低成本。那裡沒有談判。他們只是在降低價格,但尤其是在生物製劑領域,尤其是在增加產量方面。

  • 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,一件好事是,首先,我們對疫苗有很好的了解,它們是疫苗的一部分,實際上,他們從愛爾蘭共和軍中受益,因為沒有成本分攤。所以我們可以在卷中再次看到這一點。但對於我們確實接觸過的小分子,我想說,我們就像在 26 年只選了 1 個產品,我們會有 3 或 4 個產品,但只選了 1 個。因此,正如阿米爾所說,Eliquis,我們將拭​​目以待。我們當然知道,但我們不能在談判過程中討論正在發生的任何事情。因此,我們將在 2026 年看到這一切的影響。

  • 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.

    然後,如果明年,他們帶來了一些今年沒有包含在內的其他產品,那將是世界上的 IBRANCE,這將是 XTANDI,無論如何,這些都是他們正在接近的產品他們的LOE。因此,即使他們進入 IRA,我們的 MPV 風險也不是那麼大,因為實際上,我們降低了某些東西的價格,但不會持續很長一段時間,但會是小於其他一段時間。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,他將盡我們所能捍衛它。

  • Operator

    Operator

  • We'll take our next question from Rajesh Kumar with HSBC.

    我們將回答匯豐銀行 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.

    第一個問題是您對毛利率提供了一些非常有幫助的資訊。那裡的取值和放值是什麼?如果我們看看你們 70 年代初期的指引以及第一季實現的毛利率,我們是否會看到今年某個季度的毛利率低於 70 年代的毛利率?還是你會到 70 歲出頭,全年保持 70% 以上的利潤率?然後,從披露的資訊中很難弄清楚的是,PAXLOVID 數字如何影響毛利率?因此,如果我們能提供任何幫助,以便我們能夠正確建模,我們將不勝感激。

  • 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,我認為我們只是在毛利率接近 70% 和進入 2024 年時接近 80% 方面給出了一些顏色。我想說的是,我們的毛利率在任何一個季度都不太可能低於 70%。但我想強調的是,毛利率將會略有波動,主要是考慮到銷售組合,特別是在毛利率較低的疫苗產品組合中。

  • 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,當你看看我們第一季毛利率的表現時,與去年相比,主要影響是混合因素,即第一季 COMIRNATY 的銷售量低於去年第一季。顯然,PAXLOVID準備金的最終調整實際上也對第一季的毛利率產生了一次性的正面影響,但與組合相比影響較小。所以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 and 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? But I had a lot of mines 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. executive. So we have a very small transition with very low (inaudible) commercial plans.

    我想強調的是,在PAXLOVID上,真正讓我高興的是產品的潛在需求,對嗎?所以第一季在美國大約有 200 萬個劇本,對嗎?所以這很重要。請記住,這是我們從以前的進入市場方式轉向商業模式的季度,對嗎?但我有很多地雷正在執行,但我們沒有踩到任何一個。所以,我再次對阿米爾和美國團隊的執行方式感到非常高興。管理人員。所以我們有一個非常小的過渡和非常低(聽不清楚)的商業計劃。

  • 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,有數千家參與的、近 90,000 家藥局的執行非常好,如果我沒記錯的話,其中 90% 參與了醫療保險部分。進展非常順利。我還想提醒一下,醫療保險顯然具有不同的價格水平,因為它是透過美國政府的信貸與商業計劃相比,它們是[1,000],這是一個不同的標價。今年也存在這種差異。明年,每個人都會轉向標價,當然還有我們提供的折扣。請讓你去凱斯那裡。

  • Operator

    Operator

  • We'll take our next question from Chris Shibutani with Goldman Sachs.

    我們將回答高盛克里斯‧涉谷 (Chris Shibutani) 提出的下一個問題。

  • 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?

    如果可以的話,有兩個問題。第一個是用 Prevnar 接種肺炎球菌疫苗。上個季度,您對市場基調的看法發表了一些評論,特別是對於更成熟的成人市場。顯然,競爭正在跨越不同的類別,成人和兒童。鑑於表現相對強勁以及您如何準備比賽,您能談談您的看法嗎?

  • 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。該行業已經做出了一些新的努力,以更直接地面向消費者,例如,禮來公司(Lilly)就直接針對其肥胖產品。 Aamir,我很好奇您對整合這種方法的想法,特別是當我想到您擁有的某些產品類別(例如偏頭痛和 NURTEC)時,這會如何運作?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,我認為重申這一點是值得的。因此,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歲至64歲的基礎醫療條件人群顯然更難啟動。因此,這對我們的業務來說是真實的,對於任何即將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,我們繼續期望成長。我們在第一季做得非常好。我們看到了 6% 的成長。其主要驅動力是兒科的使用量增加以及市場份額的成長。因此,兒科在第一季看到了很多轉換,PCV 13 到 20。

  • 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。我們繼續看到我們現在的表現非常好。我們擁有98%的市佔率。我們知道 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將會是什麼。但我們可以採取很多措施來捍衛我們在成人市場的業務。首先,我們在零售環境和非零售環境中部署了組合合約方法。

  • 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 (inaudible). 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.

    同樣重要的是要注意,在非零售環境中,許多有組織的客戶更喜歡工作流程管理來儲存 1 種滿足當前所有需求的疫苗(聽不清楚)。因此,在我們了解更多之前,我認為捍衛我們在成人市場份額的最佳方法是繼續做我們正在做的事情。這就是要集中精力最大限度地擴大我們在成人市場的機會,儘管會收縮,然後繼續推動兒科的成長。

  • 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.

    關於你關於消費者的第二個問題,正如你所指出的,吸引和激活消費者是我們業務中非常非常重要的一部分。在疫苗領域也是如此。舉幾個例子,PAXLOVID 和 NURTEC 等類別就是如此。我們一直在尋找加強這種聯繫的方法。我要舉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其疫苗資格並預約的機制。這是我們可以帶來的價值的一個很好的例子。如果我們可以做更多的事情,為患者以及我們在其他類別的業務創造價值,我們當然會尋求探索。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Alexandre, very quickly, anything on PCV in international markets?

    Alexandre,很快,有關於國際市場 PCV 的任何資訊嗎?

  • 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 [pre nup] 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,我們也實現了一些關鍵的里程碑。因此,我們在歐洲獲得了兒科 Prevnar 20 的批准。我們也在日本獲得了批准,日本是澳洲和許多其他國家非常重要的市場。所以這很棒,因為我們希望在全球範圍內非常成功的[婚前]特許經營權的基礎上再接再厲。如您所知,我們在 [130] 市場擁有獨家 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 where 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 outlook. 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 remediation 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.

    僅對成人發表 1 則評論。我們仍在大多數歐洲市場上獲得 VTC 推薦。但在德國和法國,我們看到了非常好的皮卡。為什麼?因為他們擴大了 Prevnar 20 展望所涵蓋的人口。例如,在德國,我們提供了 18 至 59 歲的高危險群和 60 歲及以上的所有人群。自那以後,我們在二月進行了修復,我們在德國的利用率得到了很好的提升,正如我們所說,我們即將在法國推出。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.

    這是一個非常好的批准和推薦節奏。

  • Operator

    Operator

  • We'll take our next question from Mohit Bansal with Wells Fargo.

    我們將接受富國銀行莫希特·班薩爾 (Mohit Bansal) 提出的下一個問題。

  • 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 (inaudible) expenses in '25 as well?

    也許有個問題想問戴夫。只是想了解當您開始全年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,但如果您考慮一年中的利潤率狀況,應該如何大家想一想嗎?據我了解,第四季度的營收可能會受到 COMIRNATY 收入的影響。然後,當我們進入 2025 年時,我們是否應該考慮更好的槓桿作用,或者您認為 25 年也可能有更多的機會(聽不清楚)支出?

  • 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,沒有給予——因為我們不指導毛利率的季度預期,我只想說,我們圍繞改善銷售商品成本的重點是一個多年的旅程。我們正在努力改善的這些成本需要時間來調整併進一步實施使該基礎設施更加有效和高效的方法。

  • 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. P

    因此,我認為這不會對 2024 年產生重大影響,但影響會更大——如果會的話,那將是 2024 年末,但更多是在 25 年和 26 年。但還會有更多。隨著我們了解得越來越多,隨著我們更具體地制定計劃,我們一定會分享一些相關細節。磷

  • 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.

    我們將回答摩根大通的克里斯·肖特 (Chris Schott) 提出的下一個問題。

  • 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 Abrysvo 而言,很快就跟進了先前的評論。您能否向我們介紹一下我們在零售通路的合約工作和進展方面的最新情況,以及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,您現在有簽約的想法嗎?或者隨著時間的推移,這仍然會改變嗎?

  • 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 就在 VYNDAQEL 上。顯然數字非常強勁。也許只是快速更新我們在該市場的滲透率。我們該往哪裡走──還能走多高?該藥物還有多少增長跑道?

  • 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,正如我所說,在 Abrysvo 上,我們正​​在推動合約對話,因此我們稍後會分享更多內容。就您對 VYNDA 的問題而言,VYNDA 的季度業績非常強勁。我們年增了 96%,但重要的是,比上個季度也成長了 41%。當你觀察司機時,我認為有一些事情。其中一些是暫時的。因此,批發商和專業藥局有一些採購模式。

  • 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.

    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。因此,所有這些都會導致第一季的推注。但重要的是,我們在 VYNDA 上表現強勁的部分原因是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,我們曾討論過要達到 30% 到 50% 的範圍。我們正在接近這個目標的頂端。而且仍然有很大的機會來識別更多的患者。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維持這種勢頭,可能不會達到我們在第一季看到的速度,但我們將繼續與 VYNDA 一起表現良好。

  • 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,有什麼要補充的嗎?

  • 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,很快。在國際方面,我們也有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。因為我們基本上有將 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.

    現實是我們仍然有成長的機會,因為,是的,在法國等市場,我們談論的是 50%,但在義大利等其他市場,我們約為 30%,日本為 28%。因此,仍然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。我們將再回答 2 個問題,因為時間不多了。

  • Operator

    Operator

  • We'll take our next question from Tim Anderson with Wolfe Research.

    我們將回答沃爾夫研究公司的蒂姆·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,今年是管道讀數繁忙的一年。我想知道,Mikael,您能否指出即將發布的 1 或 2 個最讓您興奮的較大讀數,您對哪些內容充滿信心,因為這可能會創造價值?所以我並不是尋找所讀出的所有內容的描述。也許只有一兩個最讓你興奮的。

  • 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,讓我們大家興奮不已。

  • 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 mastozimab for both hemophilia A and B to continue to grow our hematology franchise momentum. (inaudible) in 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 III. And then (inaudible) pipeline onsegrimab which I think pending readout has really a breakthrough mechanism.

    是的是的。我對用於治療 A 型和 B 型血友病的 Mastozimab 可能獲得批准感到興奮,這將繼續增強我們的血液學特許經營勢頭。 (聽不清楚)在治療方面,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指定的 RMAT,所以我們對此感到非常興奮。相對近期,讀數即將到來。 COVID/流感聯合疫苗,[859]讀出第三階段。然後(聽不清楚)管道onsegrimab,我認為待讀出確實具有突破性機制。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • Anything from your side, Chris?

    克里斯,你這邊有消息嗎?

  • 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 Lorbrenla, which will be presented at ASCO. We could define the growth of Lorbrenla over the next decade. There's 2 other upcoming readouts.

    也許只是再次提及 Lobrrenla 可能前所未有的新 5 年數據,該數據將在 ASCO 上公佈。我們可以定義洛布倫拉未來十年的成長。還有另外 2 個即將發布的讀數。

  • Albert Bourla - Chairman of the Board & CEO

    Albert Bourla - Chairman of the Board & CEO

  • That's good if we are talking to that (inaudible)

    如果我們能談論這個就好了(聽不清楚)

  • 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.

    還有另外 2 個讀數對我們很重要,第一個是防波堤,這是 BRAF 陽性大腸直腸癌的第一線機會。提醒一下,這佔大腸直腸癌的 12%。預後特別差,所以我們期待 Breakwater 的讀數,然後,如前面提到的,VERATEC 2 在二線 ER 陽性乳癌中的應用,它也可以定義未來的路徑。

  • 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將由 Steve Scala 和 TD Cowen 提出。

  • 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 post things 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 2 個問題。在輝瑞 mRNA 流感疫苗效力試驗中,65 歲以上所顯示的效力是否優於已核准的流感疫苗?該數據原定於去年發布,但我認為我們還沒有得到更新。其次,您對肥胖的興趣更為廣泛。所以danuglipron的前景並不好。補充看起來不太可能,但是——這只是 1 個非常簡單的數據點。 pfizer.com 上關於肥胖症臨床領先地位的帖子表明某些事情正在取得進展。那麼輝瑞公司在肥胖方面到底取得了什麼進展呢?

  • 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 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,Mikael 也可以評論,當然還有 mRNA 流感疫苗。但我多次說過,首先,新陳代謝是一個傳統上非常有優勢的領域,而且這是我們有權贏得的領域。因此,我們很強大,並繼續在整個地區進行投資,因為我們擁有基礎設施。肥胖是其中很大一部分,甚至是市場的一部分。因此,我們將透過現有的作用機制和新的作用機制在肥胖方面非常積極。

  • We said repeatedly that we had 3 agents right now in the clinic, and we have multiple on the (inaudible) but we are progressing. But we don't have anything to say per se right now because on 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,我們診所目前有 3 名藥劑,我們有多種藥劑(聽不清楚),但我們正在取得進展。但我們現在本身沒有什麼可說的,因為在等待、一些數據和其他數據上,現在談論它們還為時過早。這就是為什麼我們不對此發表太多評論。可以說,我們將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 疫苗以及您想添加到肥胖系列中的任何產品怎麼樣?

  • 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.

    我認為你在肥胖問題上說得很好。我將重點放在 mRNA 疫苗,只是說我們確實分享了我們在第一代流感 mRNA 平台的結果事件試驗中擁有 18 至 59 人的非常可靠的數據。實際上,我們進一步完善了該產品,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。該技術目前已應用於 18 至 59 歲的新冠肺炎/流感組合疫苗,而且很快我們就會得到結果。我們認為這確實是近期將這兩種病毒納入簡單管理方法的機會。對於 65 歲以上,您提到的是第一代的早期試用。我們現在已將重點轉移到第二代,並正在準備對其進行後續臨床研究。

  • 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 -- utilization in Fermany you have a wonderful day. Thank you.

    謝謝你,米凱爾。謝謝運營商,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滿意。隨著我們在執行 5 個優先事項方面不斷取得進展,我們有信心繼續為患者、股東和公司提供服務。再次感謝您對輝瑞的關注。我們希望您在弗馬尼度過愉快的一天。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。