輝瑞 (PFE) 2025 Q4 法說會逐字稿

內容摘要

  1. 摘要
    • Q4 2025 營收為 176 億美元,年減 3%;全年營收 626 億美元,年減 2%,但若排除 COVID-19 產品,全年營收成長 6%
    • 2026 年財測維持不變,預期營收 595-625 億美元,調整後 EPS 2.80-3.00 美元,COVID 產品預計進一步下滑
    • 本季財報優於預期,全年調整後 EPS 3.22 美元(去年 3.11 美元),盤後市場反應正面
  2. 成長動能 & 風險
    • 成長動能:
      • 非 COVID 產品組合 Q4 年增 9%,全年新上市及併購產品營收 102 億美元,年增 14%
      • Metsera、YaoPharma、3SBio 等併購與授權案強化管線,推動長期成長
      • VESPER-3(GLP-1 月打減重藥)數據正面,預計 2028 年起陸續申請上市,搶攻 1500 億美元肥胖市場
      • Seagen、Biohaven 等併購產品整合順利,腫瘤學產品線持續擴展
      • AI 應用於研發、生產、商業與病患互動,提升生產力並加速創新
    • 風險:
      • COVID 產品(Comirnaty、Paxlovid)需求大幅下滑,Q4 年減約 40%,未來仍將持續壓抑營收
      • 2026-2028 年多項重磅藥品面臨專利到期(LOE)壓力,預期 2026 年有 15 億美元營收受影響
      • 部分產品與管線資產認列 44 億美元減損,顯示產品組合調整壓力
  3. 核心 KPI / 事業群
    • 全年新上市及併購產品營收:102 億美元,年增 14%
    • Q4 非 COVID 產品營收:年增 9%
    • Q4 調整後毛利率:約 71%,全年調整後毛利率 76%
    • Nurtec(偏頭痛口服藥):2025 年在口服 CGRP 類別新處方市佔 83%,持續領先
  4. 財務預測
    • 2026 年營收預估 595-625 億美元,COVID 產品約 50 億美元
    • 2026 年調整後毛利率預期維持中高 70% 區間
    • 2025 年資本支出(CapEx)未明確揭露
  5. 法人 Q&A
    • Q: VESPER-3 月打 GLP-1 的耐受性與劑量設計細節?與現有週打產品相比的市場定位?
      A: 耐受性良好,月打與週打不良反應分布相似,無明顯增加。Phase 3 會允許劑量下調,預期可進一步優化耐受性。月打劑型可降低用藥負擔,對患者、醫師、保險商具吸引力,有助於從週打產品轉換。
    • Q: Phase 3 設計會如何調整?還有什麼新數據會在 ADA 公布?
      A: Phase 3 會測試不同劑量遞增方案,並納入 9.6mg 月打高劑量。ADA 會公布更多 amylin 類藥物與 GLP-1 組合數據,以及口服 GIPR 拮抗劑等早期管線進展。
    • Q: VESPER-3 安慰劑組體重變化?Vyndaqel 2028 年後有無專利策略?
      A: 安慰劑組體重基本持平,詳細數據將於 ADA 公布。Vyndaqel 假設 2028 年專利到期,目前無進一步評論。
    • Q: GLP-1 月打劑型有無機會拉長至雙月或更長?Phase 3 會考慮哪些差異化設計?
      A: 目前 '3944 目標為月打維持劑型,另有一款三月打候選藥在 Phase 1。Phase 3 除代謝疾病外,也會探索心血管、神經等適應症與組合療法。
    • Q: Seagen 併購整合進度?PD-1xVEGF 管線如何在競爭中突圍?
      A: Seagen 整合順利,西雅圖團隊穩定,PADCEV 等產品推進多項 Phase 3。PD-1xVEGF ('4404) 具高親和力與多重 VEGF 結合,已啟動多項腫瘤適應症 Phase 3,有望與 ADC 組合差異化。

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 fourth-quarter 2025 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,歡迎參加輝瑞公司2025年第四季財報電話會議。今天的通話將會被錄音。此時,我想把電話交給首席投資者關係官兼高級副總裁弗朗西斯卡·德馬蒂諾。請便,女士。

  • Francesca DeMartino - Chief Investor Relations Officer, Senior Vice President

    Francesca DeMartino - Chief Investor Relations Officer, Senior Vice President

  • 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 fourth quarter and full year 2025 via a press release that is available on our website at pfizer.com.

    早安,歡迎參加輝瑞公司的財報電話會議。我是弗朗西斯卡·德馬蒂諾,首席投資者關係官。我謹代表輝瑞團隊,感謝您的參與。本次電話會議將透過 pfizer.com 網站進行音訊網路直播。今天早些時候,我們透過新聞稿發布了 2025 年第四季和全年業績,該新聞稿可在 pfizer.com 網站查閱。

  • I'm joined today by Dr. Albert Bourla, our Chairman and CEO; and Dr. Chris Boshoff, our Scientific Officer -- Chief Scientific Officer; and Dave Denton, our CFO. Albert, Chris and Dave have some prepared remarks, and we will then open the call for questions.

    今天與我一同出席的有:我們的董事長兼執行長 Albert Bourla 博士;我們的首席科學官 Chris Boshoff 博士;以及我們的財務長 Dave Denton。艾伯特、克里斯和戴夫有一些準備好的演講稿,之後我們將開放提問環節。

  • Members of our leadership team will be available for the Q&A session. 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 the 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.

    我們的領導團隊成員將出席問答環節。在開始之前,我想提醒各位,我們將做出一些前瞻性陳述,並討論一些非GAAP財務指標。我建議您閱讀我們幻燈片演示文稿中的免責聲明、我們今天上午發布的新聞稿以及我們向美國證券交易委員會提交的文件中的披露信息,所有這些文件都可以在輝瑞公司官網 (pfizer.com) 的投資者關係網站上找到。本次電話會議中的前瞻性陳述受重大風險和不確定性因素的影響,僅代表截至電話會議當日的觀點,我們不承擔更新或修改任何陳述的義務。

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

    接下來,我將把電話交給阿爾伯特。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Francesca. So 2025 was a very good year for Pfizer. I'm very pleased with strong execution to deliver and, frankly, over deliver on our financial commitments. We exceeded expectations for revenues and Adjusted diluted EPS while also returning $9.8 billion to shareholders via our quarterly dividend. We grew overall operational revenue for full year 2025 when excluding COVID-19 products, achieved solid double-digit growth in recently launched and acquired products and expanded Adjusted gross margins.

    謝謝你,弗朗西斯卡。所以2025年對輝瑞來說是非常好的一年。我對我們強而有力的執行力非常滿意,不僅實現了我們的財務承諾,而且坦白說,還超額完成了任務。我們不僅超額完成了營收和調整後攤薄每股收益目標,還透過季度股息向股東返還了 98 億美元。2025 年全年,若不計入 COVID-19 產品,我們的整體營運收入實現成長,近期推出和收購的產品實現了穩健的兩位數成長,調整後毛利率也得到提高。

  • Strategic actions in 2025 helped us resolve significant uncertainty, including achieving greater clarity on pricing and tariffs and demonstrating the underlying resilience of our business to deliver EPS despite the lowest ever COVID-19 season. We achieved 4 key approvals, 8 critical readouts and initiated 11 pivotal studies. And our Metsera, YaoPharma and 3SBio deals help strengthen our robust pipeline.

    2025 年的策略行動幫助我們解決了重大不確定性,包括更清晰地了解定價和關稅,並證明了我們業務的內在韌性,即使在 COVID-19 疫情史上最低的年份,也能實現每股收益。我們獲得了 4 項關鍵批准,8 項關鍵讀數,並啟動了 11 項關鍵性研究。我們與 Metsera、YaoPharma 和 3SBio 的交易有助於加強我們強大的產品線。

  • Overall, 2025 reinforced how well Pfizer can execute. We strengthened a foundation, positioning us for growth towards the end of the decade, continued impact for patient and long-term shareholder value. We have once again defined strategic priorities for the year ahead, which we presented at JPMorgan.

    整體而言,2025 年再次證明了輝瑞的執行力有多強。我們鞏固了基礎,為本十年末的成長奠定了基礎,並持續為患者和長期股東創造價值。我們再次製定了未來一年的戰略重點,並在摩根大通會議上進行了展示。

  • 2026 is an important year in a pivotal investment period as we strive for industry-leading growth after several key products lose patent for regulatory exclusivity in the next few years. Seagen, Metsera and Biohaven are the most significant strategic acquisitions in recent years. They have transformative potential for Pfizer, and we are focused on maximizing the value of in-line product portfolios and accelerating pipeline development.

    2026 年是關鍵投資期的重要一年,因為在未來幾年內,幾款關鍵產品的專利保護期將到期,我們將努力實現業界領先的成長。Seagen、Metsera 和 Biohaven 是近年來最重要的策略收購。它們對輝瑞公司具有變革性的潛力,我們專注於最大限度地發揮現有產品組合的價值並加速研發管線。

  • We made continued progress last year, integrating legacy Seagen products into our commercial portfolio. I'm also pleased with notable advances in our development programs, including a recent FDA approval for PADCEV in combination with pembro for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. We are encouraged by the opportunity to build on this with an expected regulatory decision for patients with cisplatin-eligible MIBC.

    去年,我們繼續取得進展,將原有的 Seagen 產品整合到我們的商業產品組合中。我也很高興看到我們的研發計畫取得了顯著進展,包括最近 FDA 批准 PADCEV 與帕博利珠單抗聯合用於不適合接受含順鉑化療的肌層浸潤性膀胱癌患者。我們有理由相信,即將推出針對適合接受順鉑治療的肌層浸潤性膀胱癌患者的監管決定,並以此為基礎,我們將繼續推進這項工作。

  • If successful we will substantially expand the US addressable population with up to approximately 22,500 additional patients across both cis-eligible and cis-ineligible muscle invasive bladder cancer, up from about 19,000 patients in metastatic urothelial cancer. We have a clear strategy aiming for Pfizer leadership in the next generation of therapies for chronic weight management with a highly differentiated Metsera pipeline portfolio, our YaoPharma exclusive global collaboration and licensing agreement and other Pfizer programs such as our oral GIPR antagonist candidate.

    如果成功,我們將大幅擴大美國的目標族群,在符合順式條件和不符合順式條件的肌肉層浸潤性膀胱癌患者中,新增患者人數將達到約 22,500 人,而轉移性尿路上皮癌患者人數約為 19,000 人。我們制定了明確的策略,目標是憑藉高度差異化的 Metsera 產品線組合、與 YaoPharma 的獨家全球合作和許可協議以及其他輝瑞項目(例如我們的口服 GIPR 拮抗劑候選藥物),使輝瑞在下一代慢性體重管理療法領域佔據領先地位。

  • Since closing our Biohaven acquisition a few years ago, we have globally scaled a leading migraine portfolio. It strengthened our product mix to drive significant impact both for patients and our commercial performance. Nurtec has a strong market leadership position in the oral CGRP class in 2025. In Q4, we captured 83% of new CGRP writer volume and remain the leader in new patient starts.

    自從幾年前完成對 Biohaven 的收購以來,我們已在全球擴大了領先的偏頭痛產品組合。它強化了我們的產品組合,從而對患者和我們的商業表現都產生了重大影響。2025年,Nurtec在口服CGRP類藥物領域佔據強大的市場領導地位。第四季度,我們佔據了 83% 的新 CGRP 藥物使用量,並且在新患者啟動方面保持領先地位。

  • I expect 2026 to be also a very rich year for key catalysts and we intend to deliver on our critical R&D milestones. This year, we anticipate progress with approximately 20 recently initiated and planned key pivotal studies, with 10 of them in the Metsera portfolio; and 4, with our anti-PD-1xVEGF bispecific. Among 8 expected key readouts, we anticipate, 1, for SV, our novel potential first in-class integrin beta 6-targeting vedotin ADC. The readout will be in second line plus non-squamous metastatic non-small cell lung cancer, which affects about 50,000 patients in the US and more than 200,000 patients globally.

    我預計 2026 年對於關鍵催化劑而言也將是碩果累累的一年,我們計劃實現關鍵的研發里程碑。今年,我們預計在最近啟動和計劃的約 20 項關鍵性研究方面取得進展,其中 10 項屬於 Metsera 產品組合;4 項屬於我們的抗 PD-1xVEGF 雙特異性抗體。在 8 個預期的關鍵讀數中,我們預期 SV(我們新型的潛在首個同類整合素β6標靶維多汀抗體藥物偶聯物)將有 1 個讀數。研究結果將應用於二線及以上非鱗狀轉移性非小細胞肺癌患者,這種癌症在美國影響約 5 萬名患者,在全球影響超過 20 萬名患者。

  • We are also expecting key Phase 3 readouts for ELREXFIO in double class exposed relapsed-refractory multiple myeloma and for our Lyme disease vaccine candidate. The foundation of our strategy in obesity and adjacent condition is targeting breakthrough medicines in what could be a $150 billion market.

    我們也期待 ELREXFIO 在雙重暴露復發難治性多發性骨髓瘤的 3 期關鍵數據,以及我們的萊姆病候選疫苗的數據。我們在肥胖症及相關疾病領域的策略基礎是瞄準突破性藥物,而這方面的市場規模可能高達 1500 億美元。

  • Earlier today, we announced encouraging results from our VESPER-3 study, which previously was known as Metsera-097i, the ultra-long acting investigational next-generation injectable GLP-1 receptor agonist. In a few moments, Chris Boshoff, our Chief Scientific Officer will walk through additional details and our plans for advancing our obesity portfolio this year.

    今天早些時候,我們宣布了 VESPER-3 研究的令人鼓舞的結果,該研究以前被稱為 Metsera-097i,是一種超長效的下一代注射型 GLP-1 受體激動劑。稍後,我們的首席科學官克里斯·博斯霍夫將詳細介紹我們今年推進肥胖症產品組合的計劃。

  • Oncology is another source of strength, and I'm excited by opportunities for significant progress in 2026, that was built on our established presence in breast, in genitourinary, in thoracic and gastrointestinal cancer and of course, blood cancer.

    腫瘤學是另一個優勢領域,我對 2026 年取得重大進展的機會感到興奮,這建立在我們已在乳腺癌、泌尿生殖系統癌、胸部和胃腸道癌症以及血液癌症領域取得的成就之上。

  • In addition to promising programs, such as the SV, our Oncology team is moving quickly with a robust program for '4404, the bispecific antibody licensed last year from 3SBio. We have seven near-term plans or recently started trials for '4404, including two large global Phase 3 studies, anchoring our efforts to establish this investigational medicine as a potential backbone therapy across multiple tumor types.

    除了像 SV 這樣有前途的項目外,我們的腫瘤團隊正在快速推進一項強大的項目,該項目針對的是去年從 3SBio 獲得許可的雙特異性抗體 '4404'。我們有七項近期計劃或最近啟動的 '4404 試驗,其中包括兩項大型全球 3 期研究,旨在將這種研究性藥物確立為多種腫瘤類型的潛在骨幹療法。

  • We're also pleased that the FDA has granted HYMPAVZI breakthrough therapy designation for investigation in younger pediatric patients aged 6 to 11 in hemophilia B with or without inhibitors. That's an important innovative medicine today, and we are investigating the full potential of HYMPAVZI to support more patients living with hemophilia.

    我們也很欣喜地看到,FDA 授予 HYMPAVZI 突破性療法認定,用於研究治療 6 至 11 歲患有伴或不伴抑製劑的 B 型血友病的兒童患者。這是當今一項重要的創新藥物,我們正在研究 HYMPAVZI 的全部潛力,以幫助更多血友病患者。

  • Our third strategic priority is investing to maximize post-2028 growth. We are committed to fully supporting a robust and accelerated approach to R&D, the successful commercial launch of new products and bolt-on business development while maintaining our robust dividend.

    我們的第三個策略重點是投資以實現2028年後的成長最大化。我們致力於全力支持穩健且快速的研發、新產品的成功商業化推出和附加業務發展,同時維持穩健的股利。

  • And finally, we are scaling artificial intelligence across R&D, manufacturing, commercial and patient engagement to improve productivity and accelerate innovation. We have been setting the foundation with AI-ready data, agentic workflows and compute capacity. To meet the growing AI demand over the next two years, we are expanding to more than 1,200 GPUs, largely driven by R&D application of AI.

    最後,我們正在研發、製造、商業和患者參與等領域推廣人工智慧,以提高生產力並加速創新。我們一直在利用人工智慧就緒資料、智慧工作流程和運算能力來奠定基礎。為了滿足未來兩年不斷增長的人工智慧需求,我們將GPU數量擴展到1200多個,這主要得益於人工智慧的研發應用。

  • In R&D, we are embedding AI across discovery, development, regulatory and medical to increase productivity and accelerate the pipeline and timelines. AI is optimizing supply planning and manufacturing, contributing to our manufacturing optimization program goals. In commercial, AI is helping to accelerate new product launches delivering insights for dynamic targeting and supporting personalized messaging and real-time marketing content.

    在研發領域,我們將人工智慧融入發現、開發、監管和醫療等各個環節,以提高生產力並加快研發流程和時間表。人工智慧正在優化供應鏈計畫和生產製造,為實現我們的製造優化計畫目標做出貢獻。在商業領域,人工智慧正在幫助加速新產品發布,為動態定位提供洞察,並支援個人化資訊和即時行銷內容。

  • So with that and after I described the four priorities, which describe the full picture of what we plan to do in 2026, I will turn it over to Chris to discuss for the news of the day, which are the Metsera long-acting announcement of VESPER-3. Chris?

    綜上所述,在我描述了四個優先事項(它們全面展現了我們 2026 年的計劃)之後,我將把發言權交給 Chris,讓他來討論今天的新聞,即 Metsera 公司發布的長期有效的 VESPER-3 公告。克里斯?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Thank you, Albert. It is my pleasure to discuss the VESPER-3 study results today and provide more color to our press release this morning. These data are an important advancement in our obesity portfolio because they increased significantly our confidence in the Phase 3 monthly dosing study that we expect to start later this year.

    謝謝你,阿爾伯特。今天我很高興能與大家討論 VESPER-3 研究結果,並為我們今天早上發布的新聞稿提供更多細節。這些數據是我們肥胖症產品組合的一項重要進展,因為它們大大增強了我們對預計今年稍後開始的 3 期每月給藥研究的信心。

  • To start, I'd like to review how the structure of PF'3944 drives its long half-life. Prior GLP-1 receptor agonists that rely on albumin binding to extend half-life require dissociation from the albumin protein for optimal receptor engagement, '3944 binds the GLP-1 receptor while still bound to albumin due to lipidation of the terminal end of the amino acid chain rather than in the middle. This allows for reduced clearance without reduced receptor engagement resulting in a half-life exceeding other agents that require albumin dissociation for binding.

    首先,我想回顧一下 PF'3944 的結構是如何決定其較長的半衰期的。先前依賴白蛋白結合來延長半衰期的 GLP-1 受體激動劑需要與白蛋白解離才能達到最佳的受體結合效果,而 '3944 由於氨基酸鏈末端的脂化而不是中間的脂化,因此在仍與白蛋白結合的情況下也能與 GLP-1 受體結合。這樣可以減少清除率,而不會減少受體結合,從而使半衰期超過其他需要白蛋白解離才能結合的藥物。

  • A key differentiator of '3944 is this extended half-life, which supports monthly dosing. Furthermore, given '3944 length of 41 amino acids, the molecule is considered a biologic and would be eligible for regulatory review by the BLA pathway. The right side of the slide shows previously reported data from the Phase 2b VESPER-1 study, evaluating '3944 dosed weekly and without titration. These data show dose-dependent placebo-adjusted weight loss of up to 14.1% at week 28, demonstrating the molecule's potential to deliver efficacy that is competitive with the standard of care and potentially best in class among mono agonists.

    '3944 的一個關鍵區別在於其較長的半衰期,這支持每月給藥一次。此外,由於「3944」由41個胺基酸組成,該分子被認為是生物製品,並符合BLA途徑的監管審查條件。幻燈片的右側顯示了先前報告的 2b 期 VESPER-1 研究的數據,該研究評估了每週給藥一次且不進行滴定的 '3944。這些數據顯示,在第 28 週,劑量依賴性安慰劑調整後的體重減輕高達 14.1%,這表明該分子具有與標準療法相媲美的療效潛力,並且有可能成為單一激動劑中的最佳選擇。

  • In our currently ongoing weekly Phase 3 study of '3944 VESPER-4, we are also testing a higher dose of 2.4 milligrams weekly. With VESPER-3, we aim to achieve two key objectives: first, to demonstrate that we could achieve continued weight loss when switching from weekly to monthly subcutaneous injections and maintain '3944 efficacy while reducing the dosing frequency four-fold. And second, to demonstrate that '3944 could switch to a four-fold equivalent monthly dose while maintaining a well-tolerated and favorable safety profile.

    在我們目前正在進行的每週一次的 '3944 VESPER-4 的 3 期研究中,我們也在測試每週 2.4 毫克的更高劑量。透過 VESPER-3,我們旨在實現兩個主要目標:首先,證明我們可以在從每週皮下注射改為每月皮下注射時實現持續的體重減輕,並在將給藥頻率降低四倍的同時保持 '3944 療效。其次,證明 '3944 可以改為每月四倍等效劑量,同時保持良好的耐受性和安全性。

  • Today, I will walk you through these data, which demonstrate we've successfully achieved both. The VESPER-3 Phase 2b study was designed to evaluate '3944 with monthly maintenance dosing following a titration period of up to 12 weeks. This study compares 4 different dosing regimens versus placebo with a prespecified interim tolerability analysis at week 12 and a primary reporting milestone at week 28. Arm 1 and Arm 3 are low and medium dose regimens that we plan to advance to Phase 3, and these two study arms are the focus of the data we are sharing today.

    今天,我將帶大家了解這些數據,這些數據顯示我們已經成功實現了這兩個目標。VESPER-3 2b 期研究旨在評估 '3944 在長達 12 週的滴定期後每月維持給藥的療效。本研究將 4 種不同的給藥方案與安慰劑進行比較,並在第 12 週進行預先設定的中期耐受性分析,在第 28 週進行主要報告里程碑。第 1 組和第 3 組分別是低劑量和中劑量方案,我們計劃將其推進到 3 期臨床試驗,而這兩個研究組正是我們今天分享的數據的重點。

  • Starting with our first objective. I'm pleased to share that we observed robust statistically significant weight loss across all doses tested. At week 28, placebo-adjusted weight loss was 10% and 12.3% for our planned low and medium Phase 3 doses, respectively. These results are shown in the blue bars and represent the trial's efficacy estimate.

    首先,我們從第一個目標開始。我很高興地告訴大家,我們觀察到所有測試劑量組別都出現了具有統計意義的顯著體重減輕。在第 28 週,我們計劃的低劑量和中等劑量 3 期治療組的安慰劑調整體重減輕分別為 10% 和 12.3%。這些結果以藍色長條圖的形式顯示,代表了試驗的療效估計值。

  • In the teal bars are our model predictions of the potential efficacy we would expect with monthly maintenance dosing of '3944 in the study of adults with obesity or overweight and without Type 2 diabetes, similar to VESPER-3. A model-based meta-analysis approach was used to generate these predictions. This approach uses a mathematical model to capture the weight loss trajectory over time and the dose response relationship.

    青色長條圖是我們對每月維持劑量 '3944 在肥胖或超重且無 2 型糖尿病的成年人研究中預期潛在療效的模型預測,類似於 VESPER-3。採用模型為基礎的薈萃分析方法來產生這些預測。此方法使用數學模型來捕捉體重隨時間變化的下降軌跡和劑量反應關係。

  • This model was built, taking into account the observed data from the VESPER-3 trial, the available data from other '3944 clinical studies and data from published trials of other weight loss. For the low and medium dose regimens, we see excellent concordance between our VESPER-3 clinical data in blue and our model predictions in teal, applying the same model to project the potential efficacy of the planned Phase 3 high-dose regimen of 9.6 milligrams monthly, we predict placebo-adjusted weight loss of nearly 16% at week 28.

    該模型是根據 VESPER-3 試驗的觀察數據、其他 3944 項臨床研究的可用數據以及已發表的其他減肥試驗的數據構建的。對於低劑量和中劑量方案,我們看到 VESPER-3 臨床數據(藍色)與模型預測(青色)之間具有極佳的一致性。應用相同的模型來預測計劃中的 3 期高劑量方案(每月 9.6 毫克)的潛在療效,我們預測在第 28 週時,安慰劑調整後的體重減輕將接近 16%。

  • Note the high dose is already being studied in the VESPER-4 Phase 3 study as a 2.4-milligram weekly dose. Collectively, our clinical data model predictions show that '3944 can deliver robust weight loss after switching to monthly administration and suggest that we can potentially achieve increased efficacy with a higher dose.

    請注意,VESPER-4 3 期研究中已經對高劑量進行了研究,每週劑量為 2.4 毫克。總的來說,我們的臨床數據模型預測表明,'3944 在改為每月給藥後可以帶來顯著的減肥效果,並且表明我們有可能透過更高的劑量獲得更高的療效。

  • Moreover, VESPER-3 data do not show a weight-loss plateau reached at week 28, projecting continued weight loss is expected as the study continues through week 64. With these results, we are confident that '3944 has the potential to deliver efficacy that is competitive with the standard of care and potentially best-in-class among monoagonists with a differentiated monthly dosing format.

    此外,VESPER-3 數據並未顯示在第 28 週達到體重減輕平台期,預計隨著研究持續到第 64 週,體重將繼續減輕。憑藉這些結果,我們有信心,'3944 具有與標準療法相媲美的療效,並且有可能成為具有差異化每月給藥形式的單激動劑中的同類最佳。

  • Next, I'll turn your attention to the second objective of VESPER-3 demonstrating a well-tolerated and favorable safety profile for '3944 when switching to a four-fold equivalent monthly dose. Similar to our first objective, I'm pleased to report that here too '3944 delivered. In VESPER-3 '3944 has displayed a well-tolerated and favorable safety profile that is consistent with what has been observed with weekly GLP-1 receptor agonists, observed gastrointestinal treatment-emergent adverse events were predominantly mild or moderate with no more than one instance of severe nausea or vomiting in any dose group, and no instances of severe diarrhea.

    接下來,我將把大家的注意力轉移到 VESPER-3 的第二個目標,即證明 '3944 在改為四倍等效月劑量時具有良好的耐受性和安全性。與我們的第一個目標類似,我很高興地報告,3944 也實現了。在 VESPER-3 研究中,'3944 表現出良好的耐受性和安全性,與每週 GLP-1 受體激動劑的觀察結果一致,觀察到的胃腸道治療期間出現的不良事件主要為輕度或中度,任何劑量組中嚴重噁心或嘔吐的病例均不超過 1 例,且沒有嚴重腹瀉的病例。

  • Treatment discontinuation rates for VESPER-3 weekly and monthly phases both show a compelling profile. Across the dose regimens planned for inclusion in Phase 3, five participants discontinued due to adverse events in each of the weekly and monthly phases. There were no discontinuations due to adverse events in the placebo group. We're encouraged by these results as they serve as an important proof of concept for the delivery of our four-fold equivalent monthly dose that maintains competitive tolerability, particularly given the study protocol did not limit down titration.

    VESPER-3 每周和每月治療階段的治療中斷率均顯示出令人信服的趨勢。在計畫納入 3 期臨床試驗的劑量方案中,每週和每月各有 5 名受試者因不良事件而退出試驗。安慰劑組中沒有因不良事件而中止試驗的情況。這些結果令我們感到鼓舞,因為它們有力地證明了我們能夠以四倍等效的月劑量提供具有競爭力的耐受性,尤其是在研究方案沒有限制劑量遞減的情況下。

  • The totality of tolerability data support our plans to evaluate a higher monthly dose of 9.6 milligrams in Phase 3, which is the monthly equivalent to the 2.4 milligram weekly dose currently being studied in the ongoing VESPER-4 trial. Today's encouraging results bolster our expansive obesity program. This year, we plan to advance 20-plus obesity trials, including 10 Phase 3 studies of '3944 that span chronic weight management, obesity associated comorbidities and opportunities to increase patient optionality and access.

    整體耐受性數據支持我們在 3 期臨床試驗中評估每月 9.6 毫克較高劑量的計劃,這相當於目前正在進行的 VESPER-4 試驗中研究的每週 2.4 毫克劑量的月劑量。今天所取得的令人鼓舞的成果鞏固了我們廣泛的肥胖症防治計劃。今年,我們計劃推進 20 多項肥胖症試驗,其中包括 10 項 '3944 的 3 期研究,這些研究涵蓋慢性體重管理、肥胖相關合併症以及增加患者選擇和獲得治療的機會。

  • We are targeting the first of a series of potential approvals in 2028. Looking to our early-stage programs, we are enthusiastic about Phase 2 studies with our ultra long-acting amylin analog which we believe has the potential for class-leading efficacy and combinability with '3944 in a monthly dosing format. We previously reported positive early data from the single ascending dose combination study, which showed well-tolerated starting doses and additive weight loss. We plan to show updated combination data later this year.

    我們的目標是在 2028 年獲得一系列潛在批准中的第一個。展望我們的早期項目,我們對超長效胰淀素類似物的 2 期研究充滿熱情,我們相信它具有領先的療效潛力,並且可以與 '3944 以每月一次的給藥形式聯合使用。我們先前報告了單次遞增劑量組合研究的正面早期數據,結果顯示起始劑量耐受性良好,且體重減輕效果顯著。我們計劃在今年稍後公佈更新後的組合數據。

  • We continue to advance our potentially first-in-class oral GIPR antagonist that is in Phase 2 and additional Phase 1 studies of agents with diverse modalities and mechanisms. These include an injectable ultra-long-acting GIPR agonist a potential quarterly dose injectable GLP-1 receptor agonist and oral candidates.

    我們正在繼續推進我們可能具有首創性的口服 GIPR 拮抗劑的研發,該藥物目前處於 2 期臨床試驗階段,同時我們也在進行其他具有不同作用方式和機制的藥物的 1 期臨床試驗。其中包括注射超長效 GIPR 激動劑、潛在的每季注射一次的 GLP-1 受體激動劑和口服候選藥物。

  • To summarize, today's results are clear. VESPER-3 achieved its two main objectives: reinforcing '3944 potential potent and tolerable monthly profile. The ultra-long acting GLP-1 receptor agonist serves as a foundation to our differentiated investigational obesity portfolio, delivering robust weight loss with no plateau served at week 28 in VESPER-3, while also maintaining competitive tolerability when switching to a four-fold equivalent monthly dose.

    總而言之,今天的結果很明確。VESPER-3 實現了其兩個主要目標:加強了「3944 潛在的強效且可耐受的月度特性」。超長效 GLP-1 受體激動劑是我們差異化研究性肥胖症產品組合的基礎,在 VESPER-3 試驗中,該藥物可顯著減輕體重,且在第 28 週未達到平台期,同時在換用四倍等效月劑量時仍保持良好的耐受性。

  • We are primed to execute across an expansive Phase 3 program of '3944, targeting potential approval starting in 2028. And we are pursuing differentiated combination approaches with earlier-stage agents that have the potential to deliver greater optionality to address the diverse unmet needs of patients.

    我們已做好準備,全面推進 '3944' 的 3 期臨床試驗計劃,目標是從 2028 年開始獲得潛在批准。我們正在探索差異化的聯合療法,將早期藥物用於治療,以期為患者提供更多選擇,滿足其多樣化的未滿足需求。

  • With that, I'll turn it back to Albert.

    這樣,我就把麥克風交還給阿爾伯特了。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Chris. And I just wanted to say that today's results provide a compelling validation of our unique proprietary ultra long-acting peptide platform. For the first time, we have shown that the GLP-1 receptor agonist peptides can be administered monthly while maintaining the potential for competitive efficacy and safety. We are pleased with this important milestone for the platform that reinforces both the differentiation of our technology and the significant long-term value creation opportunity that represents.

    謝謝你,克里斯。我只想說,今天的成果有力地驗證了我們獨特的專有超長效肽平台。我們首次證明,GLP-1 受體激動劑勝肽可以每月給藥一次,同時保持其具競爭力的療效和安全性。我們對平台所取得的這一重要里程碑感到高興,這不僅鞏固了我們技術的差異化優勢,也展現了其所代表的巨大長期價值創造機會。

  • And with that now, I will turn it over to Dave that he will discuss the excellent results of the quarter. So Dave?

    接下來,我將把發言權交給戴夫,由他來談談本季的優異成績。所以,戴夫?

  • David Denton - Chief Financial Officer, Executive Vice President

    David Denton - Chief Financial Officer, Executive Vice President

  • Great. Thank you, Chris and Albert, and good morning, everyone. Let me begin today by highlighting that our strong financial performance for both the fourth quarter and the full year directly reflects our continued disciplined execution of our key strategic priorities. We resolved certain and significant uncertainties in our business and made strategic investments aimed at driving revenue growth later this decade and beyond. Looking ahead, Pfizer is approaching an exciting phase, where recently launched and acquired products and a strong pipeline are anticipated to spur growth towards the end of this decade.

    偉大的。謝謝克里斯和阿爾伯特,大家早安。首先,我要強調的是,我們第四季和全年強勁的財務表現直接反映了我們持續嚴格執行關鍵策略重點。我們解決了業務中某些重大不確定因素,並進行了旨在推動本十年及以後收入成長的策略投資。展望未來,輝瑞即將進入一個令人興奮的階段,預計近期推出和收購的產品以及強大的研發管線將在本十年末推動公司成長。

  • With that said, this morning, I'll provide our full year and fourth quarter -- full year and fourth quarter 2025 results, then I'll touch on our cost improvement initiatives as well as our capital allocation priorities. I'll finish with a few comments on our '26 guidance, which we are reaffirming today. For the full year 2025, we recorded revenues of $62.6 billion versus $63.6 billion last year representing a 2% operational decline.

    綜上所述,今天上午,我將提供我們全年和第四季度(2025 年全年和第四季度)的業績,然後我將談談我們的成本改善計劃以及我們的資本配置重點。最後,我想就我們2026年的業績指引做一些說明,我們今天再次重申這項指引。2025 年全年,我們的營收為 626 億美元,去年為 636 億美元,年減 2%。

  • Importantly, our operational revenue growth when excluding contributions from our COVID-19 projects was 6%. Full year 2025 Adjusted gross margins expanded to 76%, in line with our expectations. We will continue to drive cost improvements going forward across our manufacturing network. And on the bottom line, we reported full year 2025 diluted EPS of $1.36, versus $1.41 last year and Adjusted diluted earnings per share of $3.22 versus $3.11 LY, ahead of expectations.

    值得注意的是,若不計入 COVID-19 項目帶來的貢獻,我們的營運收入成長率為 6%。2025 年全年調整後毛利率成長至 76%,符合我們的預期。我們將繼續在整個製造網路中推進成本優化。最後,我們公佈了 2025 年全年稀釋後每股收益為 1.36 美元,而去年為 1.41 美元;調整後稀釋後每股收益為 3.22 美元,而去年為 3.11 美元,均高於預期。

  • Pfizer's recently launched and acquired set of products delivered $10.2 billion in revenues for the full year of '25 while growing approximately 14% operationally versus last year. We plan to continue to invest behind these two product groups to drive their future performance to enable the company to partially offset our LOEs over the next several years.

    輝瑞公司近期推出和收購的產品組合在 2025 年全年創造了 102 億美元的收入,同時營運收入比上一年增長了約 14%。我們計劃繼續投資這兩個產品組,以推動其未來的業績成長,從而使公司能夠在未來幾年內部分抵消我們的支出。

  • Now turning to the fourth quarter of '25, we recorded revenues of $17.6 billion, a decrease of 3% operationally versus the same period of LY largely driven by an approximate 40% operational year-over-year decline in our COVID products. The decline was primarily due to Comirnaty receiving a narrow recommendation for vaccines in the US and Paxlovid, which experienced reduced demand from lower infection rates. Having said that, our non-COVID product performance was solid, growing 9% operationally versus the same period of last year.

    現在來看 2025 年第四季度,我們的收入為 176 億美元,與去年同期相比,營運收入下降了 3%,這主要是由於我們的 COVID 產品營運收入同比下降了約 40%。下降的主因是Comirnaty在美國疫苗建議範圍有限,以及Paxlovid因感染率下降而需求減少。儘管如此,我們的非新冠產品業績表現穩健,營運成長了 9%,與去年同期相比。

  • Our results demonstrate the effectiveness of our refined commercial strategy. We saw solid contributions across our product portfolio, primarily driven by ABRYSVO, ELIQUIS, Prevnar and the Vyndaqel family. Adjusted gross margin for the fourth quarter was approximately 71%, primarily reflecting the product mix in the quarter, including lower commodity sales versus fourth quarter of '24 as well as continued strong cost management.

    我們的研究結果證明了我們改進後的商業策略的有效性。我們的產品組合均取得了穩健的貢獻,這主要得益於 ABRYSVO、ELIQUIS、Prevnar 和 Vyndaqel 系列產品。第四季調整後的毛利率約為 71%,主要反映了該季度的產品組合,包括與 2024 年第四季相比大宗商品銷售額下降,以及持續強勁的成本控制。

  • Future improvements in our manufacturing footprint remained a top priority going forward. As a reminder, over the past two years, our Adjusted gross margins have generally remained in the mid- to upper 70s. Excluding Comirnaty, which has a 50-50 profit split with our partner, BioNTech, we achieved approximately $600 million in savings from Phase 1 of our manufacturing optimization program through 2025 and with additional savings expected in '26 and '27.

    未來,改善我們的生產佈局仍然是我們的首要任務。提醒一下,過去兩年,我們的調整後毛利率通常保持在 70% 到 70% 之間。除與合作夥伴 BioNTech 50-50 利潤分成的 Comirnaty 外,到 2025 年,我們透過製造優化計畫的第一階段實現了約 6 億美元的節省,預計在 2026 年和 2027 年還將節省更多。

  • Total Adjusted operating expenses were $7.4 billion for the fourth quarter of '25, in line with last year. But looking at the components, adjusted SI&A expenses decreased 5% operationally, primarily driven by focused investments and ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products and lower spending in corporate-enabling functions.

    2025 年第四季調整後的總營運支出為 74 億美元,與去年同期持平。但從組成部分來看,經調整的SI&A費用在營運方面下降了5%,這主要是由於重點投資和持續的生產力提高,從而減少了各種產品的營銷和促銷支出以及企業賦能職能的支出。

  • Adjusted R&D expense increased 4% operationally, primarily driven by the increase in spending in oncology and obesity product candidates, partially offset by a net decrease in spending due to pipeline focus and optimization, including the expansion of our digital capabilities.

    經調整的研發費用在營運方面增加了 4%,主要原因是腫瘤和肥胖症候選產品的支出增加,部分被由於產品線集中和優化(包括擴大我們的數位化能力)而導致的支出淨減少所抵消。

  • Now turning to the bottom line. In the fourth quarter, our reported diluted GAAP performance was a loss per share of $0.29. Our Adjusted diluted earnings per share performance was a profit of $0.66, ahead of our expectations due to our overall gross margin and cost management performance.

    現在來說說最終結果。第四季度,我們報告的稀釋後GAAP業績為每股虧損0.29美元。由於整體毛利率和成本控制方面的出色表現,我們調整後的稀釋後每股收益為盈利0.66美元,超出預期。

  • In support of our goal to enhance R&D productivity and focus on high-impact medicines, our fourth quarter GAAP results reflect strategic decisions in our development plans and updated long-range revenue forecast for certain products and pipeline assets. As a result, we recorded approximately $4.4 billion of non-cash intangible asset impairments related to several medicines in development as well as in-line products.

    為了支持我們提高研發效率並專注於高影響力藥物的目標,我們第四季度的 GAAP 業績反映了我們在發展計畫中的策略決策,以及對某些產品和在研資產的更新長期收入預測。因此,我們記錄了約 44 億美元的幾種在研藥物和在售產品相關的非現金無形資產減損。

  • It is important to note that one of the asset indications we deprioritized was disitamab vedotin in bladder cancer is largely the result of the recently strong study readouts, expanded indications and related higher long-term revenue projections for PADCEV.

    值得注意的是,我們降低優先順序的資產適應症之一是膀胱癌的 disitamab vedotin,這主要是由於 PADCEV 最近強勁的研究結果、擴大的適應症以及相關的更高長期收入預測。

  • PADCEV is an asset we will continue to invest behind and thus diminishing the value of DV in bladder cancer. I will also mention, while impairment decisions are based on current valuations of individual assets, overall, the Seagen portfolio is progressing ahead of our expectations. These decisions highlight our focus on delivering future growth as well as innovation.

    PADCEV 是我們將繼續投資的資產,因此會降低膀胱癌中 DV 的價值。我還要提一下,雖然減損決定是基於單一資產的當前估值,但總體而言,Seagen 的投資組合進展超出了我們的預期。這些決定凸顯了我們對未來成長和創新的重視。

  • We are on track to deliver the majority of the anticipated $7.2 billion in total net cost savings from our productivity programs by the end of 2026. We expect additional savings of $700 million in '26 and $200 million in '27 from Phase 1 of the Manufacturing Optimization Program for a total of $1.5 billion in savings by the end of '27.

    到 2026 年底,我們的生產力提升計畫預計將帶來 72 億美元的淨成本節約,而我們正按計畫推進,力爭實現這一目標的大部分。我們預計,製造優化計畫第一階段將在 2026 年節省 7 億美元,在 2027 年節省 2 億美元,到 2027 年底總共節省 15 億美元。

  • In addition, we exceeded our savings targets through '25 from our cost realignment program and as previously communicated, the R&D savings achieved in '25 under the cost realignment program is expected to be reinvested in '26 and is reflected in our '26 R&D guidance range.

    此外,我們透過成本調整計畫在 2025 年超額完成了節約目標,並且正如先前所溝通的那樣,在 2025 年透過成本調整計畫實現的研發節約預計將在 2026 年重新投資,並反映在我們 2026 年的研發指導範圍內。

  • We remain committed to achieving the expected $5.7 billion of total net savings from our cost realignment program by the end of '26, at which time we will have met our savings commitment under the program. Going forward, we will continue to focus on identifying further productivity opportunities and efficiencies.

    我們仍致力於在 2026 年底前透過成本調整計畫實現預期的 57 億美元淨節省目標,屆時我們將履行該計畫下的節省承諾。展望未來,我們將繼續致力於尋找進一步提高生產力和效率的機會。

  • 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 over the long term, growing our dividend, reinvesting in our business at the appropriate level of financial return and in the future, the potential to make value-enhancing share repurchases.

    現在讓我快速談談我們的資本配置策略,該策略旨在提高股東的長期價值。我們的策略包括維持並長期提高股息,以適當的財務回報水準對我們的業務進行再投資,並在未來有可能進行增值股票回購。

  • And in '25, we returned $9.8 billion to shareholders via the quarterly dividend, invested $10.4 billion in internal R&D, invested approximately $8.8 billion in business development transactions, primarily reflecting the Metsera acquisition and the 3SBio licensing deal. And as a reminder, our leverage is expected to end 2025 at near a 2.7 times target following the close of the Metsera transaction.

    2025 年,我們透過季度分紅向股東返還了 98 億美元,投資 104 億美元用於內部研發,投資約 88 億美元用於業務發展交易,主要反映了對 Metsera 的收購和 3SBio 的許可協議。再次提醒大家,在完成 Metsera 交易後,我們的槓桿率預計將在 2025 年底達到 2.7 倍的目標值附近。

  • However, given the next few years of LOE headwinds, we expect the leverage to remain at this current level or slightly higher through the LOE period. Additionally, the planned sale of our stake in ViiV will further improve our balance sheet. When including the ViiV proceeds, we have approximately $7 billion in BD capacity. Now let me turn quickly to our full year '26 guidance, again, which remains unchanged.

    然而,鑑於未來幾年 LOE 帶來的不利因素,我們預計槓桿率將在 LOE 期間保持在目前的水平或略高一些。此外,計劃出售我們在 ViiV 的股份將進一步改善我們的資產負債表。加上 ViiV 的收益,我們擁有約 70 億美元的 BD 融資能力。現在讓我再次快速地談談我們 2026 年全年的業績預期,該預期保持不變。

  • We expect total company full year '26 revenues to be in the range of $59.5 billion to $62.5 billion and full year '26 Adjusted diluted earnings per share to be in the range of $2.80 to $3 a share, which reflects our expectations of strong contributions across our product portfolio, mid-70s Adjusted gross margin, continued focus on strong cost management, all while prioritizing investments in our business to drive growth by the end of this decade.

    我們預計公司 2026 年全年總收入將在 595 億美元至 625 億美元之間,2026 年全年調整後稀釋每股收益將在 2.80 美元至 3 美元之間,這反映了我們對產品組合強勁貢獻、調整後毛利率達到 70% 左右、持續專注於強有力的成本管理,同時優先投資於業務增長的預期。

  • Our COVID products are expected to trend lower again in '26 with revenues of approximately $5 billion. We continue to expect stable revenue contributions from our non-COVID product portfolio, which incorporates an expectation of approximately $1.5 billion in revenue compression due to products impacted by anticipated generic entry in '26. Revenues at the midpoint, excluding COVID and LOE products are expected to grow approximately 4% operationally year-over-year. And lastly, I will mention that we will continue to monitor currency fluctuation as the year progresses.

    預計我們的新冠產品在 2026 年將再次呈下降趨勢,營收約 50 億美元。我們繼續預期非 COVID 產品組合將帶來穩定的收入貢獻,其中包括因 2026 年預期仿製藥上市而導致約 15 億美元的收入壓縮預期。不計 COVID 和 LOE 產品,預計中間值收入將年增約 4%。最後,我想提一下,我們今年將繼續關注貨幣波動情況。

  • In closing, let me continue to emphasize that over the next few years, our focus is on investing in key assets and managing upcoming LOEs, mainly from 2026 to 2028. At the end of the decade, growth is expected to be driven by our advancing R&D pipeline, the business development initiatives we've already executed and the ongoing progress of products we've recently launched or acquired. Our goal is to invest strategically balancing cost savings with funding high-value products designed to ensure long-term and sustainable growth potential for our shareholders.

    最後,我想繼續強調,在接下來的幾年裡,我們的重點是投資關鍵資產和管理即將到來的LOE,主要是從2026年到2028年。到本十年末,成長預計將由我們不斷推進的研發項目、我們已經執行的業務發展計劃以及我們最近推出或收購的產品的持續進展所驅動。我們的目標是進行策略性投資,在節省成本的同時,為高價值產品提供資金,以確保股東獲得長期可持續的成長潛力。

  • And with that, I'll turn it back to Albert and begin the Q&A.

    接下來,我將把麥克風交還給阿爾伯特,開始問答環節。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, David, and congratulations for an excellent quarter. Now operator, please assemble the queue.

    謝謝你,大衛,恭喜你本季業績出色。操作員,請整理隊列。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Chris Schott, JPMorgan.

    克里斯‧肖特,摩根大通。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Great. Thanks so much for the question. Just had maybe a two-parter on the VESPER-3 data. I guess, first, can you just elaborate any more on the tolerability you saw here? And maybe just specifically, is there anything more you can say about vomit rates or any differences you saw between the mild or moderate dosing arms?

    偉大的。非常感謝你的提問。剛剛完成了關於 VESPER-3 數據的兩部分內容。首先,您能否詳細說明一下您在這裡看到的容忍度?具體來說,您能否再說明嘔吐率,或者您在輕劑量組和中劑量組之間觀察到的任何差異?

  • And then just maybe bigger picture, if we consider the two doses that are moving forward from VESPER-3, it seems like you have a drug that clearly had solid weight loss. It's got monthly dosing. At the same time, that weight loss might be a bit below what you saw in the weekly or Zepbound. I just wanted to get your views on what role you see that type of profile playing in the market. Thanks so much.

    然後,從更宏觀的角度來看,如果我們考慮 VESPER-3 中正在推進的兩種劑量,似乎這種藥物確實具有顯著的減肥效果。它每月服用一次。同時,這種減肥效果可能比你在每週或 Zepbound 上看到的要差一些。我只是想了解一下您對這類人才在市場中扮演的角色有何看法。非常感謝。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Excellent. And of course, I will start with Chris, which I suspect will be the one who will receive most of the questions today, and I love it. So -- and then maybe we'll ask of course the commercial guys to speak a little bit about it. So Chris, why don't you start?

    出色的。當然,我先從克里斯開始,我估計他今天會收到最多的問題,我喜歡這樣。所以——然後我們或許會請廣告界的人士談談這方面的情況。克里斯,你先開始吧?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Yeah. Thanks for the question. So obviously, we will share the full tolerability data at our oral presentation at ADA in June. We are really encouraged by the observed distribution of AEs across weekly and monthly. And you could have expected potentially that when patients switch to a four-fold higher dose, we're going to have a higher number of sudden discontinuations and nausea and vomiting, we did not, nicely distribution between the monthly as well as the weekly.

    是的。謝謝你的提問。顯然,我們將在 6 月的 ADA 會議上進行口頭報告,分享完整的耐受性數據。我們對觀察到的AE在每周和每月的分佈感到非常鼓舞。你可能會預期,當患者改用四倍劑量時,會出現更多突然停藥、噁心和嘔吐的情況,但我們並沒有看到這種情況,每月和每週的劑量分佈情況都很好。

  • Just to remember for this study, there was no step-down titration was allowed, which is unusual for obesity trials. But that will obviously not happen in the Phase 3 study, we will allow down-titration. Regarding the different doses, as we pointed out, low and medium was presented today. The higher dose is already being tested in VESPER-4 because previous prediction models indicated that it will be well tolerated and we should test 2.4 milligrams weekly, which is happening now. And in the monthly study we'll test 9.6 milligrams as pointed out.

    需要記住的是,這項研究不允許逐步減少劑量,這在肥胖症試驗中是不尋常的。但顯然在 3 期研究中不會發生這種情況,我們將允許劑量遞減。關於不同劑量,正如我們指出的,今天介紹了低劑量和中劑量。VESPER-4 試驗中已經測試了更高的劑量,因為先前的預測模型表明,該劑量耐受性良好,我們應該每週測試 2.4 毫克,而現在正在進行這項測試。如同先前所提到的,我們將在每月的研究中測試 9.6 毫克。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • All right. Why don't we go -- Aamir, how do you see this play in commercial and then Alexandre?

    好的。我們不妨這樣——阿米爾,你覺得這部劇在商業上如何發展?然後亞歷山大呢?

  • Aamir Malik - Chief US Commercial Officer, Executive Vice President

    Aamir Malik - Chief US Commercial Officer, Executive Vice President

  • I think when you look at the clinical data, I think what it suggest to us, clearly, is that '3944 from an efficacy perspective has the potential to deliver efficacy that's competitive with the standard of care and potentially best-in-class against [monotherapy] So we think when you take that efficacy and then you combine it with a lower medication burden through a monthly dose, that's a value proposition that's going to resonate with patients, with providers and with payers because persistency and simplicity matter. And it also gives us the opportunity to switch patients from weekly onto monthly therapy.

    我認為,從臨床數據來看,很明顯,從療效角度來看,'3944 有潛力達到與標準療法相媲美的療效,甚至可能優於[單藥療法]。因此,我們認為,當這種療效與每月一次的低用藥負擔相結合時,這種價值主張將引起患者、醫療服務提供者和支付方的共鳴,因為堅持治療和簡便用藥至關重要。這也讓我們有機會將患者的治療頻率從每週一次改為每月一次。

  • So we think '3944 is going to be a compelling therapy full stop. And then you add to that the opportunity that exists from the other assets that we have in our portfolio with our commercial capabilities to execute in US and international, and I think it gives us a lot of confidence around the commercial potential.

    所以我們認為「3944」將會是一種極具吸引力的療法,毋庸置疑。再加上我們投資組合中其他資產所帶來的機會,以及我們在美國和國際上的商業執行能力,我認為這讓我們對商業潛力充滿信心。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Yeah. Thank you, Aamir. The surprise, I think, so far with this market, it is how well it is performing outside the US. So Alexandre, what's your take?

    是的。謝謝你,阿米爾。我認為,到目前為止,這個市場最令人驚訝的地方在於它在美國以外的表現非常出色。亞歷山大,你的看法是什麼?

  • Alexandre De Germay - Chief International Commercial Officer, Executive Vice President

    Alexandre De Germay - Chief International Commercial Officer, Executive Vice President

  • That's right. Just -- what's really interesting in this category is actually the size of the market, ex-US is projected to be $150 billion and 40% of that is actually ex-US. There are two things that are really interesting in this category that are unique and that reinforce the potential of these assets. First, is the out-of-pocket category. Because in most countries, when we introduced innovation, we have to go through reimbursement negotiation and often translate into price reduction in this category.

    這是正確的。真正有趣的是,這個類別的市場規模實際上很大,美國以外的市場預計將達到 1500 億美元,其中 40% 實際上是美國以外的市場。在這個類別中,有兩件事非常有趣,它們獨一無二,並強化了這些資產的潛力。首先是自付費用類別。因為在大多數國家,當我們推出創新產品時,我們必須進行報銷談判,通常會轉化為此類產品的價格降低。

  • We see that there are high willingness to pay out of pocket across all mature markets, either be in Europe or in Australia or Canada, and we see price point being across 250 to 350 which is higher than what we had expected. And when we look at the latest release from our competitors in this category, we see that there is higher willingness to pay from all those geographies, including actually also emerging markets where we also see high prevalence.

    我們看到,在所有成熟市場,無論是歐洲、澳洲或加拿大,消費者都願意自掏腰包支付,價格區間在 250 到 350 之間,比我們預期的要高。當我們查看該類別中競爭對手的最新產品時,我們發現所有這些地區的消費者都表現出更高的支付意願,實際上也包括新興市場,在這些新興市場,我們也看到這種趨勢非常普遍。

  • The second is the time to market because it's going to be mostly an out-of-pocket category, the time after approval at the EMEA will be instant and where we will be able to actually commercialize those products. So that will drive also rapid penetration in the market.

    第二個因素是上市時間,因為這主要是一個自費類別,在 EMEA 獲得批准後,我們將能夠立即將這些產品商業化。因此,這也將推動市場快速滲透。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Alexandre. Next question, please.

    謝謝你,亞歷山大。下一個問題。

  • Operator

    Operator

  • Vamil Divan, Guggenheim Securities.

    瓦米爾·迪萬,古根漢證券公司。

  • Vamil Divan - Equity Analyst

    Vamil Divan - Equity Analyst

  • Thanks for taking the questions. So just maybe building off this, Chris, you just talked a little bit about this in a prior question around down titration in Phase 3. Can you just elaborate a little bit more on that kind of how you are designing your Phase 3s and allowing for flexibility of the patient maybe you're dealing with any sort of side effects and maybe that improves overall the profile you see from Phase 2?

    謝謝您回答問題。所以,克里斯,或許可以以此為基礎,你剛才在關於 3 期臨床試驗中滴定的問題中稍微談到了這一點。您能否再詳細解釋一下您是如何設計三期臨床試驗的,以及如何考慮到患者的靈活性,例如如何處理各種副作用,從而改善二期臨床試驗的整體效果?

  • And then my other question is actually is beyond VESPER-3. You mentioned this at ADA. I'm curious what other data we may get from either your internal programs or from the Metsera portfolio at ADA vis-a-vis your internal GIPR. Do you expect to provide that Phase 2 data there? Thank you.

    那麼我的另一個問題其實是超出 VESPER-3 範圍的。您在ADA會議上提到過這一點。我很好奇我們還能從你們的內部專案或 ADA 的 Metsera 產品組合中獲得哪些數據,以了解你們的內部 GIPR。您預計會在那裡提供第二階段的數據嗎?謝謝。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Thank you very much for the question. Just a reminder again for the VESPER-3 data we presented today is only two step-up doses. You used to four, five step-up doses to get to the desired dose in this study, there's only two step-up doses. So the Phase 3 design for VESPER-6 will test different titrations as well as, as we pointed out, the additional dose of 9.6 milligrams which is currently being tested in VESPER-4 as 2.4 milligrams weekly.

    非常感謝您的提問。再次提醒大家,我們今天展示的 VESPER-3 數據僅包含兩個遞增劑量。以往需要四到五次遞增劑量才能達到所需劑量,而本研究只需要兩次遞增劑量。因此,VESPER-6 的 3 期設計將測試不同的滴定方案,以及我們指出的額外劑量 9.6 毫克,目前正在 VESPER-4 中以每週 2.4 毫克的劑量進行測試。

  • Regarding the next -- the rest of the portfolio, we're obviously excited about the platform in general. It's a very differentiated platform. As you know, we previously presented data for the ultra-long-acting amylin '3945 also called MET-233, where the observed additive weight loss when combining '3944 and '3945 was 5% at day 8 and single agent ultra-long amylin previous data showed at day 36, 8.4% placebo-adjusted weight loss. So we should share later this year, including ADA, updated date on amylin and potential early data for the combination of the amylin plus '3944.

    至於接下來——也就是投資組合的其餘部分,我們顯然對整個平台感到非常興奮。這是一個非常獨特的平台。如您所知,我們先前已發表了超長效胰淀素'3945(也稱為MET-233)的數據,其中觀察到'3944和'3945聯合使用時,第8天體重減輕了5%,而單藥超長效胰淀素的先前數據顯示,第36天安慰劑調整後的體重減輕了8.4%。因此,我們將在今年稍後分享,包括 ADA、胰淀素的最新日期以及胰淀素加 '3944 組合的潛在早期數據。

  • We also, as you know, in our portfolio, excited about the rest of the Phase 2 programs, which including a first in -- potential first-in-class GIPR antagonist oral that was discovered, conceptualized internally, that's currently in the randomized Phase 2 experience and also the more broader Phase 1 program of peptides, including an ultra-long GLP-1 that's potentially monthly quarterly, that's currently in Phase 1 as well as our additional oral portfolio, including the oral GLP-1 recently acquired from YaoPharma.

    如您所知,我們投資組合中的其他 2 期項目也令我們感到興奮,其中包括一種潛在的首創口服 GIPR 拮抗劑,該藥物由我們內部發現和構思,目前正在進行隨機 2 期試驗;以及更廣泛的 1 期肽類藥物項目,其中包括一種超長效 GLP-1,該藥物可能按月或按季度給藥,此外是口服的口服藥物組合

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉,TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Thank you so much. In the VESPER-3 data, did the placebo arm gain weight or lose weight? And the second question is not on obesity, but Pfizer has been quite adamant about no life beyond December '28 for Vyndaqel. Should we completely rule out any sort of strategy whatsoever such as settlement with generic companies on patents Pfizer holds?

    太感謝了。在 VESPER-3 數據中,安慰劑組的體重是增加了還是減輕了?第二個問題與肥胖無關,但輝瑞公司一直堅決表示,Vyndaqel 的生命週期不會超過 2028 年 12 月。我們是否應該完全排除任何形式的策略,例如與仿製藥公司就輝瑞持有的專利達成和解?

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Steve. Let me take the Vyndaqel because I have been asked multiple times. Right now, we are assuming that the patent will be lost at the end of 2028. And I don't have any other comments to make on that. These are very sensitive topics. So I'm moving to Chris now to talk about the placebo arm of what was the weight lost there.

    謝謝你,史蒂夫。讓我來回答 Vyndaqel 的問題吧,因為已經有人問我多次了。目前,我們假設該專利將於 2028 年底失效。我對此沒有其他評論。這些都是非常敏感的話題。現在我請克里斯談談安慰劑組的減重情況。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Again, the full data will present at ADA, but in this case, as VESPER-3, actually, the placebo arm was very stable, not really up or down, but you'll see the data at ADA.

    完整的數據將在 ADA 會議上公佈,但就 VESPER-3 而言,安慰劑組實際上非常穩定,沒有明顯的上升或下降,但您將在 ADA 會議上看到數據。

  • Operator

    Operator

  • Geoff Meacham, Citibank.

    傑夫‧米查姆,花旗銀行。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • Hey, guys. Morning and congrats on the data today, again, a few on the new data today. So when you look at the PK/PD, are you guys set with monthly being the longest dosing interval to preserve efficacy? Or is it potentially -- is it feasible to extend to every two-month dosing?

    嘿,夥計們。早安,再次恭喜今天公佈的數據,今天又公佈了一些新數據。那麼,在研究藥物動力學/藥效學時,你們是否認為每月一次是維持療效的最長給藥間隔?或者,是否有可能-是否可以將給藥間隔延長至每兩個月一次?

  • And then on your Phase 3 plans, is it your sense these are likely to be the standard type of metabolic studies that we'd expect to do? Or would you pursue any maybe inflammation or neuropsych indications? Or would you pursue GLP-1 active comparator studies? Just trying to think of how you could separate yourself in a broad Phase 3 program. Thank you.

    那麼,關於您的第三階段計劃,您認為這些很可能是我們預期會進行的標準代謝研究類型嗎?或者您會進一步探究是否有發炎或神經精神方面的跡象嗎?或者您會進行 GLP-1 活性對照研究嗎?我只是在想,如何在龐大的第三階段專案中脫穎而出。謝謝。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Yeah. Thank you, Geoff. So Chris, monthly or more and then additional studies.

    是的。謝謝你,傑夫。所以克里斯,每月或更多,然後還有其他研究。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • So thank you for the question. So '3944 is, as we demonstrated the first peptide that can be administered monthly. And potentially, yes, we can go longer, but for '3944, our aim is as a monthly maintenance therapy. As I mentioned, we do have another molecule, a peptide currently in Phase 1, which has a prodrug propeptide with a potential for three monthly administrations. That's currently in Phase 1, and we should, in the next couple of months, get additional PK/PD data from that molecule, which will be a potential opportunity to go to three monthly.

    謝謝你的提問。因此,正如我們所證明的,'3944 是第一個可以每月給藥的勝肽。理論上,我們可以堅持更長時間,但對於 '3944' 來說,我們的目標是作為每月一次的維持治療。正如我之前提到的,我們還有另一種分子,一種目前處於 1 期臨床試驗階段的勝肽,它含有前藥前肽,有可能每三個月給藥一次。目前該藥物處於 1 期臨床試驗階段,在接下來的幾個月裡,我們應該會獲得該分子的更多藥物動力學/藥效學數據,這將為每三個月進行一次給藥提供潛在機會。

  • The second question, the initial Phase 3 programs VESPER-4, VESPER-5 and VESPER-6. VESPER-4 is the one in patients without Type 2 diabetes that's currently ongoing with weekly testing, including the high dose of 2.4 milligram weekly, VESPER-5 in patients with Type 2 diabetes and VESPER-6, the study that will include monthly dosing. Beyond that, we plan to start seven studies. We haven't showed or revealed what these studies are going to be. But you're absolutely correct that beyond cardiovascular metabolic, we are looking at other opportunities to differentiate and also to differentiate with our combinations, for instance with Amylin or with the GIPR currently in Phase 1.

    第二個問題,即最初的第三階段計劃 VESPER-4、VESPER-5 和 VESPER-6。VESPER-4 是針對非 2 型糖尿病患者的研究,目前正在進行每週測試,包括每週 2.4 毫克的高劑量;VESPER-5 是針對 2 型糖尿病患者的研究;VESPER-6 是一項將包括每月給藥的研究。除此之外,我們也計劃進行七項研究。我們尚未展示或透露這些研究的具體內容。但您說得完全正確,除了心血管代謝之外,我們還在尋找其他差異化的機會,以及透過組合療法實現差異化,例如與 Amylin 或目前處於 1 期臨床試驗的 GIPR 組合療法。

  • Operator

    Operator

  • Terence Flynn, Morgan Stanley.

    Terence Flynn,摩根士丹利。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Hi. Thanks for taking the questions. Maybe two also for me on the VESPER-3 data. I know you want to hold a lot of data until ADA, but just was wondering if you can provide any high-level details on the baseline characteristics, so either BMI or gender mix. I know sometimes those can vary across studies.

    你好。謝謝您回答問題。或許我也從 VESPER-3 數據得到了兩個結果。我知道你們想保留大量數據直到 ADA,但我只是想知道你們能否提供一些關於基線特徵的高級細節,例如 BMI 或性別組成。我知道有時候這些結果在不同的研究中會有所不同。

  • And then on the tolerability side, again, one question when you have longer dosing intervals is the duration of GI side effects. And so any qualitative commentary there, if that's longer than one or two days. Thank you.

    在耐受性方面,當給藥間隔較長時,一個問題是胃腸道副作用的持續時間。因此,任何定性評論,如果超過一兩天的話。謝謝。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thanks. Chris, again, that goes to you.

    謝謝。克里斯,這又要歸功於你了。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Okay. Just to start with the demographics. The study was conducted in the US only. And I think, as you know, there are differences, especially in AE and tolerability, discontinuations between US-only patient populations. So that's one. The rest of the detailed demographics will be presented at ADA, but it's as expected from a small US-based Phase 2 study. The next question was?

    好的。我們先從人口統計開始。這項研究僅在美國進行。而且我認為,如您所知,美國患者群體與美國患者群體之間存在差異,尤其是在不良事件和耐受性、停藥方面。這是其中之一。其餘詳細的人口統計數據將在 ADA 會議上公佈,但這符合一項小型美國 2 期研究的預期結果。下一個問題是?

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • What was the next question? Tolerability?

    下一個問題是什麼?耐受性如何?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • On tolerability. As we said it before, we are encouraged by the overall tolerability. It is similar to what you expect for GLP-1 class, but Specifically, we can move to monthly with a distribution of AEs across weekend monthly. That didn't give us alarm that's switching to monthly, suddenly, there's a cluster of discontinuations or significant AEs.

    關於耐受性。正如我們之前所說,我們對整體的容忍度感到鼓舞。它與 GLP-1 課程的預期類似,但具體來說,我們可以改為每月一次,AE 分佈在周末。這並沒有讓我們感到擔憂,因為改為每月一次的治療方案後,突然出現了一系列停藥或重大不良事件。

  • As I pointed out earlier as well, there's no -- there's only one severe nausea, one severe vomiting across the whole program, no severe diarrhea. So overall, we're very encouraged by the safety profile. And again, ADA will share the whole AE profile.

    正如我之前指出的那樣,整個計畫中只有一次嚴重的噁心和一次嚴重的嘔吐,沒有嚴重的腹瀉。總的來說,我們對它的安全性非常滿意。此外,ADA 將分享完整的 AE 檔案。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    阿卡什‧特瓦里,傑富瑞集團。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • Hey. Thanks so much. So the data in second-line plus NSCLC has been pretty underwhelming so far versus docetaxel. Is your team confident that you can deliver a superior profile with your upcoming Phase 3 with B6A. Or are you going to need to enrich in B6A high-expressing patients. Can you help frame expectations for this readout?

    嘿。非常感謝。因此,與多西他賽相比,目前在二線及以上非小細胞肺癌治療方面的數據相當令人失望。您的團隊是否有信心在即將到來的與 B6A 的第三階段合作中交付卓越的成果?或者你需要富集 B6A 高表達患者。您能否幫忙解釋一下大家對這次結果的預期?

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Chris?

    克里斯?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • So you're referring to sigvotatug vedotin, yes?

    所以你指的是 sigvotatug vedotin,對嗎?

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • Yeah.

    是的。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Correct. Okay. So this is a second-line study, I should point out against docetaxel, the Phase 3 study, there's also additional Phase 3 study ongoing, just a reminder, which is first line, which is sigvotatug vedotin plus pembrolizumab versus pembrolizumab in the TPS high PD-L1 high population. In the single agent activity we've seen was the response rate was over 30% with a median overall survival in the Phase 1 study, which approached 16.3 months.

    正確的。好的。所以這是一項二線研究,我應該指出,它是與多西他賽(3期研究)進行比較的。另外還有一項正在進行的3期研究,提醒一下,這是一線研究,即在TPS高PD-L1高人群中,sigvotatug vedotin聯合pembrolizumab與pembrolizumab單藥治療的比較。在我們看到的單藥治療活動中,反應率超過 30%,1 期研究中的中位總存活期接近 16.3 個月。

  • So overall, we're encouraged by the data with the combination study with SV plus pembrolizumab. We saw overall response at 57% with disease control rate of over 90%. So we are confident in the two studies. I agree with you that the second-line study against docetaxel, none of the ADCs have really showed a benefit over docetaxel, but everything we've seen so far, so gives us confidence in the trial. That will be the first study to read out.

    總的來說,我們對 SV 加 pembrolizumab 聯合治療研究的數據感到鼓舞。整體反應率為 57%,疾病控制率超過 90%。因此,我們對這兩項研究結果都很有信心。我同意你的觀點,在針對多西他賽的二線研究中,沒有一種抗體藥物偶聯物(ADC)真正顯示出優於多西他賽的優勢,但我們目前所看到的一切都讓我們對這項試驗充滿信心。這將是第一個已公佈的研究結果。

  • And the second study to read out will be the one with pembrolizumab versus pembrolizumab. It's an even-driven study. Events are slower than we expected. So that could mean either ARM are performing better, but we should update you on the study results in the coming months -- first half of this year.

    第二項要發表的研究是帕博利珠單抗與帕博利珠單抗的比較研究。這是一項均衡的研究。事件進展比我們預期的要慢。所以這可能意味著兩種 ARM 架構的效能都更好,但我們將在未來幾個月(今年上半年)向您更新研究結果。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Excellent, Chris. So the next question, please.

    太棒了,克里斯。那麼,請問下一個問題。

  • Operator

    Operator

  • Asad Haider, Goldman Sachs.

    阿薩德·海德爾,高盛集團。

  • Asad Haider - Analyst

    Asad Haider - Analyst

  • Great, and thanks for all the detail on the clinical catalysts. Maybe just one on portfolio realignment, Albert, with respect to just this recent divestment of your stake in the HIV joint venture with Glaxo. Just broadly, what innings are we in, in terms of just portfolio pruning or realignment, noting that you've also recently announced a new reorganization incorporating your global Hospital and biosimilars business? Thanks.

    太好了,感謝您提供關於臨床催化劑的所有詳細資訊。阿爾伯特,或許可以就投資組合調整談一點,特別是關於你最近出售與葛蘭素史克愛滋病合資企業的股份這件事。整體而言,就投資組合精簡或重組而言,我們目前處於哪個階段?值得注意的是,您最近還宣布了一項新的重組計劃,將您的全球醫院和生物相似藥業務納入其中。謝謝。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • I think Chris can also comment on that, but let me given that you address the question to me. I think we have done most of our pruning of our pipeline right now. So the things that we are continuing right now at large are things that we believe they are the ones to invest and we keep investing very, very few exceptions of things that were already there and we had some issues to discontinue or to divest. So I think -- from that aspect, I think we are doing very well. Chris, anything to add there?

    我認為克里斯也可以就此發表評論,但既然你向我提問,那就讓我來回答吧。我認為我們目前已經完成了大部分流程精簡工作。所以,我們現在繼續投資的項目,主要是我們認為值得投資的項目,我們一直堅持投資,只有極少數例外情況,例如一些原本就存在但因為某些問題需要停止或剝離的項目。所以我覺得——從這個角度來看,我們做得非常好。克里斯,你還有什麼要補充的嗎?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Yeah, we're focusing just on the four therapeutic areas, and we're doing 2025 significant prioritization and focus the program. And as you know, identified up to $500 million savings in R&D, which is now reinvested in Phase 3 programs. And this year, as Albert pointed out, we plan to start approximately 20 Phase 3 programs driving the portfolio.

    是的,我們目前只專注於四個治療領域,並且我們正在對 2025 年的計劃進行重要的優先排序和重點關注。如您所知,我們在研發方面節省了高達 5 億美元,這些資金現在已重新投入第三階段專案。正如艾伯特指出的那樣,今年我們計劃啟動大約 20 個第三階段項目,以推動投資組合的發展。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • And maybe -- Dave also can add a little bit color on that. But I just wanted to say that when you speak about creating synergies or creating cost savings in R&D that we reinvest, we don't mean going forward with discontinuation of program, actually, with increase of programs. It's going to be by deploying AI, which already happened in 2025 with excellent results that creates significant productivity gains. This is where we are reducing the cost of R&D. And we all reinvested to more programs that, as you see, we are starting 20 pivotal studies in '26. Dave?

    或許——戴夫還可以補充一些細節。但我只想說,當您談到在研發領域創造協同效應或節省成本並進行再投資時,我們指的並不是停止現有項目,實際上,我們指的是增加項目。這將透過部署人工智慧來實現,而人工智慧已經在 2025 年投入使用,並取得了顯著成效,從而帶來了巨大的生產力提升。這就是我們降低研發成本的地方。我們把所有資金都重新投入到更多專案中,正如你所看到的,我們在 2026 年啟動了 20 項關鍵研究。戴夫?

  • David Denton - Chief Financial Officer, Executive Vice President

    David Denton - Chief Financial Officer, Executive Vice President

  • Yeah, I just would just add on to that. As we look at our in-line portfolio of products, we always continue to look to see how we can maximize the value. ViiV is just a good example of a non-strategic asset for us, monetizing that in such a way that we can redeploy that capital at higher returns in the future. As you pointed out, we did create a sterile injectable and biosimilar set of products, of which we're focused on driving productivity across that set of product portfolio. And we will continue to do that as we think about our product portfolio going forward.

    是的,我只想補充一點。在審視我們現有的產品組合時,我們始終在尋找如何最大化其價值的方法。ViiV 對我們來說就是一個很好的非策略性資產的例子,我們可以透過這種方式將其貨幣化,以便將來能夠以更高的回報重新部署這些資本。正如您所指出的,我們確實開發了一系列無菌注射劑和生物相似藥產品,我們正致力於提高該產品組合的生產力。我們將繼續這樣做,並將此作為我們未來產品組合規劃的一部分。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    Courtney Breen,Bernstein。

  • Courtney Breen - Equity Analyst

    Courtney Breen - Equity Analyst

  • Thanks so much for the question today. Just perhaps building on the conversation that was just taking place. As you talk about the 20-plus pivotal studies that are starting this year, we're seeing kind of a midpoint $11 billion guide for R&D in '26. How do we think about '27 as you study start to annualize?

    非常感謝您今天提出的問題。或許只是在剛才的對話基礎上繼續探討。正如您所說,今年將啟動 20 多項關鍵研究,我們看到 2026 年研發投入的中位數指引為 110 億美元。當你開始學習年化時,我們如何看待「27」?

  • And then kind of combining that with the element that you just raised out a bit of the AI investment, the 1,200 GPU deployment that you're making kind of when and where will we begin to see impact from that strategy? And will that impact anything in the operations of R&D of the pivotal trials? Or should we be thinking more about innovation on the research side over the long run? Thank you so much.

    然後,結合您剛才提到的AI投資和1200個GPU的部署,我們什麼時候、在哪裡才能開始看到這項策略的影響?這會對關鍵性試驗的研發運作產生任何影響嗎?或者,我們是否應該從長遠角度來考慮研究方面的創新?太感謝了。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Courtney, that's a very good question. As you can understand, we don't give guidance for 2027. But I will ask Dave to give some color.

    Courtney,你問得好。正如您所理解的,我們不提供 2027 年的指導。但我會請戴夫補充一些細節。

  • David Denton - Chief Financial Officer, Executive Vice President

    David Denton - Chief Financial Officer, Executive Vice President

  • Yeah. I guess contextually, if you just think about R&D, as we cycled from '25 into '26, with the business development transactions that we've done, we've actually increased the burden and the load of work that needs to be done within our R&D infrastructure. At the same time, we're investing about $11 billion in R&D. So we are being able to be more productive in the infrastructure across R&D and take on more substrate to be able to focus on creating medicines for the end of the decade and beyond.

    是的。我想從背景來看,如果你只考慮研發,從 2025 年到 2026 年,隨著我們進行的業務發展交易,實際上增加了我們研發基礎設施需要完成的工作負擔和工作量。同時,我們在研發方面投入了約 110 億美元。因此,我們能夠在研發基礎設施方面提高效率,並承擔更多基礎工作,從而能夠專注於為本十年末及以後研發藥物。

  • So I think what we're trying to do is continue to refresh improve the productivity across our R&D platform to invest those dollars back into R&D to continue to forward advance the programs that we have underway and the programs that we're developing. As you know, 2026 is a big start year for us from a science perspective. We will continue to focus on those investments going forward.

    所以我認為我們正在努力做的是不斷提升我們研發平台的生產力,將這些資金重新投入研發,以繼續推進我們正在進行且正在開發的專案。如您所知,從科學角度來看,2026 年對我們來說是一個重要的開端。我們將繼續專注於這些投資。

  • Operator

    Operator

  • Umer Raffat, Evercore ISI.

    Umer Raffat,Evercore ISI。

  • Umer Raffat - Equity Analyst

    Umer Raffat - Equity Analyst

  • Hi, guys. Two quick ones, if I may. First, on the GLP monotherapy. Could you remind us if the 9.6 milligram monthly dose was the reaction to the data today? Or is that already being contemplated? And then secondly, on the emerging tolerability data for your GLP amylin combo, how are you feeling on that? And do you think you can fit the GLP plus amylin in a single pill? Thank you.

    嗨,大家好。可以的話,請容許我快速回答兩個問題。首先,關於 GLP 單藥治療。請問9.6毫克/月的劑量是否是針對今天發表的數據所做的反應?或者說,這方面已經在考慮了?其次,關於您 GLP 胰淀素組合的最新耐受性數據,您對此有何感想?你認為能把 GLP 和胰淀素裝進一顆藥丸裡嗎?謝謝。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Okay. Thank you, Umer. So on the first question, a reminder that the 2.4 milligrams is already being tested as a weekly regimen as a high dose in VESPER-4, and that decision was made based on the modeling based meta-analysis. And as we showed today, our modeling predicts very well between what we actually observed and by the modeling predicted for 3.2 milligrams and 4.8 milligrams. So we have confidence in the modeling also for 9.6 milligrams or the 2.4 milligrams

    好的。謝謝你,烏默。關於第一個問題,需要提醒的是,2.4 毫克已經作為每週一次的高劑量方案在 VESPER-4 中進行測試,該決定是基於基於模型的薈萃分析做出的。正如我們今天所展示的,我們的模型預測結果與我們實際觀察到的結果以及模型預測的 3.2 毫克和 4.8 毫克之間的結果非常吻合。因此,我們對9.6毫克或2.4毫克的模型結果也有信心。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • And which basically what you say is that the 9.6 milligrams, it is the 2.4 milligrams.

    而你基本上是說,9.6毫克,其實是2.4毫克。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Correct.

    正確的。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • 4 times weekly, it is 9.6 milligrams monthly.

    每週 4 次,每月 9.6 毫克。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Correct, yes. Any other -- what was the second part?

    沒錯。還有其他的嗎? ——第二部分是什麼?

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Combination.

    組合。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • So just a reminder that the combination is monthly, it's amylin plus GLP-1 ultra-long monthly subcutaneous. So it's not pill. We do have an oral portfolio, and we do have some other oral medicines discovered internally, which we've not revealed yet, but currently, our oral medicines, GLP-1 and GIPR, not the amylin as oral.

    再次提醒一下,這種組合療法是每月一次,即胰淀素加 GLP-1 超長效每月一次皮下注射。所以它不是藥片。我們確實有口服藥物組合,我們還有一些內部發現的其他口服藥物,我們還沒有公開,但目前,我們的口服藥物是 GLP-1 和 GIPR,而不是口服的胰淀素。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • And how do you feel about this day?

    你對今天有什麼感想?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • And we'll show data for the amylin plus GLP-1 monthly data for the ultra long-acting monthly data at ADA. The earlier data we've shown reminder of the combination of '3944 plus '3945 was 5% at day 8. That was early data that was shown and we'll update those data later this year.

    我們將展示 ADA 的胰淀素加 GLP-1 月度數據和超長效月度數據。我們先前展示的數據顯示,'3944 加 '3945 的組合在第 8 天的收益率為 5%。以上是早期公佈的數據,我們將在今年稍後更新這些數據。

  • Operator

    Operator

  • Jason Gerberry, Bank of America.

    傑森‧格伯里,美國銀行。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • Hey, guys. Good morning. Thanks for taking my question. I apologize for the background noise. But just based on today's VESPER-3 update, just kind of curious how you're thinking about the value add of the GLP-1 amylin injectable combination relative to the monotherapy? And are you really looking to kind of compete in that ultra-high efficacy tier with agents like Lilly's triple G? Or is the value-add potentially more in GLP-1 non-responders? Just sort of curious because it seems like what you have with the monotherapy approach to make you competitive with Zepbound and MariTide? So just sort of curious how you think about the combo and where that fits.

    嘿,夥計們。早安.謝謝您回答我的問題。抱歉,背景噪音有點大。但僅根據今天發布的 VESPER-3 最新數據,我很好奇您如何看待 GLP-1 胰淀素注射劑聯合療法相對於單一療法的增值作用?你們真的想和禮來公司的三重G等藥物在超高效能藥物領域競爭嗎?或者,對於 GLP-1 無反應者來說,這種療法的附加價值可能更大?我只是有點好奇,因為你們似乎憑藉單一療法就能與 Zepbound 和 MariTide 競爭?所以我就有點好奇你對這個組合的看法,以及它應該如何融入其中。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Why don't I ask Chris to give a little bit of science behind this combination and then I will ask Aamir and Alexandre to comment on how that can be marketed.

    不如我請克里斯講解一下這種組合背後的科學原理,然後再請阿米爾和亞歷山大談談如何進行市場推廣。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Yes, we will have optionality because we are developing in Phase 3 both the single agent '3944 as well as the combination '3944 plus '3945. Everything we've seen thus far suggests us to us, to your point, that we should get increased efficacy for the combination. And that's why we hope to update data later this year, start the Phase 2 study this year and then next year start the Phase 3 study for the combination.

    是的,我們將有多種選擇,因為我們在第三階段同時開發了單代理「3944」以及組合「3944」和「3945」。到目前為止,我們所看到的一切都表明,正如你所說,這種組合應該能提高療效。因此,我們希望在今年稍後更新數據,今年開始 2 期研究,然後明年開始該聯合療法的 3 期研究。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • And then, Aamir, how do you see this playing as portfolio

    那麼,阿米爾,你認為這會如何作為投資組合發揮作用?

  • Aamir Malik - Chief US Commercial Officer, Executive Vice President

    Aamir Malik - Chief US Commercial Officer, Executive Vice President

  • Yeah, Jason. So I think the quick answer would be, look, I think we're in the very early innings of a large market where there is still significant unmet need, right? There's more convenient dosing that's needed, higher weight loss for certain BMI patients, GI tolerabilities need to improve, maintenance strategies, friction in the patient journey. So our belief is that there's not going to be one single asset that serves all those patients. People are going to have different starting points hold preferences on their dosing and route of administration comorbidities, their willingness to pay.

    是的,傑森。所以我覺得最簡單的回答是,你看,我認為我們正處於一個龐大市場的早期階段,這個市場仍然存在大量未被滿足的需求,對吧?需要更方便的給藥方式,某些 BMI 患者需要更高的減重效果,胃腸道耐受性需要改善,維持治療策略,以及患者治療過程中的摩擦。因此,我們認為不會存在一種單一的資產能夠服務所有這些患者。人們的起點不同,對劑量和給藥途徑的偏好不同,合併症也不同,支付意願也不同。

  • And what you need to win in a market like that is, one, you need a great portfolio of products that can serve all those patients and two, you need really differentiated capabilities. And I think with Chris describing not only our data today, but some of the other things that we have in our portfolio, we have the first piece in place and emerging.

    要想在這樣的市場中獲勝,你需要兩點:第一,你需要一個能夠服務所有這些患者的優秀產品組合;第二,你需要真正差異化的能力。我認為,克里斯不僅描述了我們今天的數據,還描述了我們投資組合中的其他一些內容,我們已經邁出了第一步,並且正在逐步實現目標。

  • And we feel very confident about our commercial capabilities, whether it's our field forces that are the top ranked in the US and already are seeing the majority of GLP-1 prescribers or the digital platforms that we're building like Pfizer For All that have touched over 25 million patients. So when you put that all together, we have a lot of confidence in our ability to win commercially in this market with these assets.

    我們對自己的商業能力非常有信心,無論是我們在美國排名第一的銷售團隊,他們已經接觸到大多數 GLP-1 處方醫生,還是我們正在建立的數位平台,例如已經惠及超過 2500 萬名患者的 Pfizer For All。綜上所述,我們對憑藉這些資產在這個市場取得商業成功的能力充滿信心。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you. And Alexandre, any additional?

    謝謝。亞歷山大,還有其他補充嗎?

  • Alexandre De Germay - Chief International Commercial Officer, Executive Vice President

    Alexandre De Germay - Chief International Commercial Officer, Executive Vice President

  • No.

    不。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Okay. Let's go to the next question, please.

    好的。我們進入下一個問題吧。

  • Operator

    Operator

  • Michael Yee, UBS.

    Michael Yee,瑞銀集團。

  • Michael Yee - Analyst

    Michael Yee - Analyst

  • Thank you. Two questions, one for Chris and one for Dave. On the oral GLP-1 that you guys recently in-licensed, can you just remind us how much information you knew or what data you already had? I believe there's already a large Phase 1 going. So that should add some comfort there but tell us about what you knew already on that molecule.

    謝謝。兩個問題,一個問克里斯,一個問戴夫。關於你們最近引進的口服 GLP-1,能否提醒我們一下,你們當時掌握了多少資訊或已經有哪些數據?我相信第一階段的規模已經很大了。這應該能讓人安心一些,但請告訴我們你之前對這種分子了解多少。

  • And then for Dave, you reiterated $7 billion of capacity. Can you just talk about the ability to do more in the context of the recent dividend pause or at least dividend growth pause recently given that, that does not happen very often and how you think about your dividend. Thank you.

    然後,對於戴夫,你重申了70億美元的產能。鑑於最近股息暫停或至少股息成長暫停的情況並不常見,您能否談談貴公司在股息方面的能力,以及您對此有何看法?謝謝。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Okay. Let me start with Dave at this time and then we go to Chris.

    好的。這次我們先從戴夫開始,然後再說克里斯。

  • David Denton - Chief Financial Officer, Executive Vice President

    David Denton - Chief Financial Officer, Executive Vice President

  • Yeah. So clearly, our focus is maintaining our dividend at the moment and growing our dividend over time. So it's a very important and critical structure and component of our capital allocation program. And again, we do have -- coming into this year, we had $6 billion in BD capacity. It's actually gone up a bit as we've announced the pending liquidation of the ViiV asset. So that actually is a good example of how we're looking at the set of assets that we have within Pfizer and understanding how we can best monetize them over time. So with that, I'll turn it over to Chris.

    是的。因此,很顯然,我們目前的重點是維持股息水平,並隨著時間的推移提高股息。因此,它是我們資本配置計劃中非常重要和關鍵的結構和組成部分。而且,今年初,我們的BD產能為60億美元。由於我們宣布即將清算 ViiV 資產,其價格實際上略有上漲。所以這其實是一個很好的例子,說明我們如何審視輝瑞公司擁有的資產,並了解如何才能隨著時間的推移最好地實現這些資產的貨幣化。那麼,接下來就交給克里斯了。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Thank you very much. 5002 is the YaoPharma oral small molecule, which is not done at Lupron Scaffold. It's currently in Phase 1, and we've acquired it through an exclusive global collaboration and license agreement with YaoPharma. And we plan to conduct Phase 1 studies and also combination studies with our GIPR antagonist that's currently in the randomized experience in Phase 2. And we're currently transitioning all the work to the US to start Phase 1 studies in the US, including manufacturing in the year.

    非常感謝。 5002是耀製藥的口服小分子藥物,並非由Lupron Scaffold公司研發。目前該項目處於第一階段,我們透過與耀藥集團的獨家全球合作和許可協議獲得了該項目。我們計劃進行 1 期研究,以及與目前正在進行 2 期隨機試驗的 GIPR 拮抗劑的共同研究。我們目前正在將所有工作轉移到美國,以便在美國啟動 1 期臨床試驗,包括年內開始生產。

  • Operator

    Operator

  • Alex Hammond, Wolfe Research.

    Alex Hammond,Wolfe Research。

  • Alexandria Hammond - Equity Analyst

    Alexandria Hammond - Equity Analyst

  • Thanks for taking the question. So one of the key readouts guided for '26 is that Lyme disease vaccine VALOR study but a few on this. When could we expect an update and what are expectations for the launch if positive. What does vaccine contracting look like and what channels will be the key target for you? And I guess, finally, how big could this opportunity really be?

    感謝您回答這個問題。因此,2026 年的關鍵閱讀之一是萊姆病疫苗 VALOR 研究,但對此知之甚少。我們何時能收到更新訊息?若消息屬實,發表會有哪些預期?疫苗合約的簽訂方式是怎麼樣的?你們的主要目標管道是什麼?最後,我想問的是,這個機會究竟有多大?

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Yes, Lyme diseae?

    是的,萊姆病?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Yeah. Thank you. I'll start. So thank you very much. This could be a first-in-class vaccine for Lyme disease, the Phase 3 VALOR trial. It's a multivalent protein subunit vaccine targeting all 6 out of surface proteins of Verallia burgdorferi. The study we expect to read out first half of this year. Just a reminder, approximately 400,000 people in the US and 132,000 people in Europe, affected by Lyme disease. And as you know, significant long-term morbidity and long-term sequelae. So a vaccine specifically in certain regions of the world could be very, very important.

    是的。謝謝。我先來。非常感謝。這可能是首個治療萊姆病的疫苗,目前正處於 VALOR 3 期臨床試驗階段。它是一種多價蛋白亞單位疫苗,針對伯氏疏螺旋體表面的全部 6 種蛋白。我們預計今年上半年公佈這項研究結果。提醒一下,美國約有 40 萬人,歐洲約有 13.2 萬人受萊姆病影響。如您所知,這會導致嚴重的長期併發症和長期後遺症。因此,疫苗在世界某些地區可能非常非常重要。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Chris. We're very, very waiting to see the date of that. That would be a huge solution for an unmet medical need. Let's move to the next question, please.

    謝謝你,克里斯。我們非常非常期待看到具體日期。這將是解決尚未滿足的醫療需求的絕佳方案。我們進入下一個問題吧。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    莫希特·班薩爾,富國銀行。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Great. Thank you very much for taking my question, and one more on the VESPER program here. Would like to understand what kind of target profile you are looking at from the Phase 3 trial? I'm asking because with the GLP-1, you kind of see mid- to high teens kind of weight loss, there's an optimized GLP-1? And if you try to push it beyond that, you could probably start to run into tolerability issues. What makes you think that this longer acting GLP-1 could provide higher weight loss than that vis-a-vis better tolerability or do you think that monthly is probably the biggest differentiator here? Thank you.

    偉大的。非常感謝您回答我的問題,以及關於 VESPER 計劃的另一個問題。我想了解您在三期臨床試驗中關注的是哪種目標族群特徵?我這麼問是因為,使用 GLP-1 後,體重通常會減輕十幾磅到十幾磅,是不是 GLP-1 已經優化過了?如果你試圖超越這個限度,你可能會開始遇到耐受性問題。為什麼您認為這款長效 GLP-1 能比另一種 GLP-1 提供更高的減肥效果和更好的耐受性?或者您認為每月一次給藥可能是最大的差異?謝謝。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Chris?

    克里斯?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Thank you very much. So it's both. We expect competitive weight loss and the data we show today, including with the predictions, but to expect from the 9.6 milligrams at 16 milligrams weight loss, we are predicted at week 28 is highly competitive, tolerable to be highly competitive and then, of course, monthly dosing, which will be highly differentiated. Just to point out, we are also planning a Phase 3 study which will evaluate switching. So patients already on weekly therapy doing well to switch those basins to monthly dosing.

    非常感謝。所以兩者都是。我們預計減肥效果將具有競爭力,今天我們展示的數據,包括預測數據,但要預期 9.6 毫克到 16 毫克的減肥效果,我們預測在第 28 週將具有很強的競爭力,耐受性良好,當然,每月給藥方案將具有很大的差異性。需要指出的是,我們還計劃進行 3 期研究,以評估轉換效果。因此,對於已經接受每週治療且效果良好的患者,可以將治療頻率改為每月一次。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Chris. And this is not only ours, of course, weekly to monthly, but also any other GLP-1s that are in the market and they want to move after they achieve a weight loss into a maintenance with only one injection rather than with four. Of course, there is also the oral solutions, but that's going for one weekly to one daily pill. Some will do it, but I think our research shows that most would like, if they are already used needle, and they would like to switch mostly to a more convenient needle, which is once a month.

    謝謝你,克里斯。當然,這不僅適用於我們每週或每月注射一次的 GLP-1 藥物,也適用於市場上任何其他 GLP-1 藥物,這些藥物可以幫助患者在減肥成功後,只需注射一次即可維持體重,而不是像以前那樣需要注射四次。當然,還有口服溶液,但那是每週服用一片或每天服用一片。有些人會這樣做,但我認為我們的研究表明,大多數人如果已經使用針頭,他們更願意換成更方便的針頭,也就是每月一次的針頭。

  • Operator

    Operator

  • Evan Seigerman, BMO Capital Markets.

    Evan Seigerman,BMO資本市場。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • Hi, guys. Thank you so much for taking my question. I just wanted to touch on your comments around investment in AI. How -- what are the metrics you're putting around that? And more broadly, I just want to ensure that this is going to drive a good return on your adjustment versus just kind of feeding into the hype?

    嗨,大家好。非常感謝您回答我的問題。我只是想就您關於人工智慧投資的評論做一些補充說明。具體來說──你們用哪些指標來衡量?更廣泛地說,我只是想確保這種調整能帶來良好的回報,而不是只是助長炒作?

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Yeah. It's a very good question, and let me start, but then I will last specific marketing achievements and R&D achievements through AI. In general, there are things in AI, but the technology is ready now. And those are deploying very, very fast. And certainly, I cannot do everything, but certainly can do more than what it is used right now to do.

    是的。這是一個很好的問題,讓我先從頭說起,但最後我會重點介紹透過人工智慧取得的具體行銷成就和研發成就。總的來說,人工智慧領域還存在一些問題,但這項技術現在已經成熟了。而且這些部署速度非常非常快。當然,我不可能包辦一切,但我肯定能做的比它現在所能做的要多得多。

  • And that has to do with how successful you are in implementing it, embedding it into your organizational footprint, embedding it into your business processes and also creating AI literacy among the employees that eventually are using this AI. With that, clearly affects everything from enabling functions and maybe Dave can speak a little bit about the things that we are doing there.

    這與你實施人工智慧的成功程度有關,與你將其融入組織架構、融入業務流程以及在最終使用該人工智慧的員工中培養人工智慧素養有關。這樣一來,顯然會影響到所有方面,包括啟用功能,也許戴夫可以談論我們在那裡正在做的事情。

  • I mean when I say enabling functions from finance, HR, legal, you name it. And of course, in R&D, where we have seen already significant productivity enhancements. In marketing that it is helping us to maximize the ROI right now and in manufacturing were a very big part of the savings that were achieved successful deployment of AI use case that is called the Golden Batch. Chris, do you want to give some specific examples?

    我的意思是,我說的是賦能財務、人力資源、法務等各部門的職能。當然,在研發領域,我們已經看到了生產力的顯著提高。在行銷方面,它幫助我們最大限度地提高投資回報率;在製造業方面,成功部署人工智慧用例(稱為「黃金批次」)所實現的節約佔了很大一部分。克里斯,你能舉一些具體的例子嗎?

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Yeah. Thank you very much for the question. So as you pointed out, in R&D, we're embedding AI in each function, meaning in discovery, medical, regulatory, safety, pharmacovigilance, clinical trial execution, and we're recruiting and embedding AI engineers in each of those functions to work with the scientists and the clinicians how to measure success, productivity, productivity, speed and cost, to be bring costs down by embedding AI and obviously, accelerating speed.

    是的。非常感謝您的提問。正如您所指出的,在研發領域,我們將人工智慧嵌入到每個職能部門,包括藥物發現、醫學、監管、安全、藥物警戒、臨床試驗執行等,我們正在招募人工智慧工程師並將其嵌入到每個職能部門,與科學家和臨床醫生合作,研究如何衡量成功、生產力、速度和成本,透過人工智慧來降低成本,並顯然加快速度。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • What about in commercial?

    商業領域呢?

  • Aamir Malik - Chief US Commercial Officer, Executive Vice President

    Aamir Malik - Chief US Commercial Officer, Executive Vice President

  • Yeah. Evan, I think metrics are at the heart of everything that we're doing with AI. I'll give you two very specific examples. One is our field force productivity. We're using AI to not only help train our field forces, but also help make their time with physicians maximize. So we invest more time with physicians rather than behind screens. Second is on the marketing side, we measure MROI.

    是的。埃文,我認為指標是我們利用人工智慧來進行一切工作的核心。我給你舉兩個非常具體的例子。一是我們現場服務團隊的生產力。我們利用人工智慧不僅是為了幫助培訓我們的現場工作人員,也是為了幫助他們最大限度地利用與醫生相處的時間。因此,我們花更多的時間與醫生交流,而不是盯著螢幕。其次是在行銷方面,我們會衡量市場投資報酬率 (MROI)。

  • And you've seen us be very disciplined, as Dave alluded to, in our SI&A spend, particularly as we're trying to grow revenue for a lot of our launch and acquired brands, and AI has absolutely helped us increase our MROI by being much, much more targeted about where we invest.

    正如戴夫所提到的,你們也看到了我們在系統整合與分析 (SI&A) 支出方面非常自律,尤其是在我們努力為許多新推出和收購的品牌增加收入的情況下,人工智慧絕對幫助我們提高了投資回報率,使我們的投資更有針對性。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Alexandre, you did fantastic things also in international with AI.

    亞歷山大,你在人工智慧領域的國際合作也取得了非常出色的成就。

  • Alexandre De Germay - Chief International Commercial Officer, Executive Vice President

    Alexandre De Germay - Chief International Commercial Officer, Executive Vice President

  • Yeah, that's right. I mean every step of the way when we interact with our customer is subject to an improvement with AI. Let me give you an example, critical planning for our rep is actually done better when it is done with AI. The quality of the interaction is listened, so that we can rerun those interactions that we can improve the quality of the interaction. We can also do targeting better way so that we have advanced targeting, thanks to AI.

    是的,沒錯。我的意思是,我們與客戶互動的每個環節都可以藉助人工智慧來改進。我舉個例子,我們所代表的關鍵規劃,如果用人工智慧來完成,效果會更好。我們會聽取互動品質的回饋,以便重新進行那些可以提升互動品質的互動。借助人工智慧,我們還可以更好地進行目標定位,從而實現更高階的目標定位。

  • And finally, imagine that operating globally with very different regulatory requirements require every country to redo and reassess every promotional pieces. With AI, we can do that instantly in all those markets. We don't need to rerun all those activities at every country. So that has massive impact on productivity and speed to market.

    最後,試想一下,在全球運營,而監管要求又千差萬別,這意味著每個國家都需要重新製作和評估每一份宣傳材料。借助人工智慧,我們可以在所有這些市場中立即做到這一點。我們不需要在每個國家都重新進行所有這些活動。因此,這會對生產效率和產品上市速度產生巨大影響。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • And Dave, maybe --

    還有戴夫,也許--

  • David Denton - Chief Financial Officer, Executive Vice President

    David Denton - Chief Financial Officer, Executive Vice President

  • Yeah. Maybe just 2 points. From an enabling functions perspective, I think about AI in us leveraging our vendors because we have big vendor technology platforms across our enterprise. And as they make investments in their platform, we're taking advantage of those and embedding those within our process, which is increasing our productivity.

    是的。或許只有2分。從賦能功能的角度來看,我認為人工智慧可以幫助我們利用供應商,因為我們的企業擁有大型供應商技術平台。隨著他們對平台進行投資,我們正在利用這些投資並將這些投資融入我們的流程中,從而提高了我們的生產力。

  • And then secondly, think about our business model, we have routine transactions, but we have a large number of products that are across literally hundreds of markets. So AI is allowing us to use those data sets to essentially automate some of those transactions to make it very efficient that today, we deploy resources to be able to do that. So now the technology is enabling us to be a lot more productive.

    其次,想想我們的商業模式,我們有日常交易,但我們有大量的產品,遍布數百個市場。因此,人工智慧使我們能夠利用這些數據集,從根本上實現某些交易的自動化,從而大大提高效率,而如今,我們需要投入資源才能做到這一點。所以現在科技讓我們能夠提高生產效率。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Yeah. So in closing, Evan, that's why we put it as one of the four imperatives strategic priorities we plan to do, which is to scale up because we have some big success. Many people are asking us, how is possible that Pfizer was able to take so much cost out of its operations without affecting the top line.

    是的。最後,埃文,這就是為什麼我們將其列為我們計劃實施的四個重要戰略重點之一,即擴大規模,因為我們已經取得了一些巨大的成功。很多人都在問我們,輝瑞公司是如何在不影響營收的情況下大幅削減營運成本的。

  • And the answer is yes. We didn't just cut cost, what we did is we improved productivity. And the main lever, of course, there was simplification efforts that also took place. But the main lever was the successful deployment of AI, where basically we are reducing the cost without that being seen in the activity. So very excited about the prospects of AI.

    答案是肯定的。我們不僅降低了成本,而且還提高了生產效率。當然,最主要的槓桿作用在於也採取了簡化措施。但最主要的槓桿是人工智慧的成功部署,我們基本上是在不影響業務活動的情況下降低成本。我對人工智慧的前景感到非常興奮。

  • Next question, please.

    下一個問題。

  • Operator

    Operator

  • Dave Risinger, Leerink Partners.

    Dave Risinger,Leerink Partners。

  • David Risinger - Analyst

    David Risinger - Analyst

  • Yes. Thanks very much and thanks for all the updates. So my question is for Chris. Chris, could you talk a little bit more about MET-233i, which I believe is now numbered '3945 Specifically, the bias of amylin relative to calcitonin, the implications for the efficacy and tolerability profile and the data we should expect at ADA? Thanks very much.

    是的。非常感謝,也感謝您提供的所有更新資訊。所以我的問題要問克里斯。Chris,可以再詳細談談MET-233i嗎?我相信它現在的編號是「3945」。具體來說,就是胰淀素相對於降鈣素的偏倚,這對療效和耐受性的影響,以及我們應該在ADA會議上看到的數據?非常感謝。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Thank you very much for the question. So this is an ultra-long-acting amylin, which was previously shown to have a monotherapy efficacy of 8.4% placebo-adjusted weight loss at day 36. It's a deal molecule, so it's not biased to the one. It's placebo-like tolerability was previously shown with the monotherapy. And that gave confidence for the -- starting the combination of '3944 and '3945.

    非常感謝您的提問。所以這是一種超長效胰淀素,先前已證明其單藥治療在第 36 天可使安慰劑調整後的體重減輕 8.4%。它是一種交易分子,所以它不會偏向某一方。先前的單藥治療已證明其具有類似安慰劑的耐受性。這給了他們信心——開始將 '3944 和 '3945 組合在一起。

  • previously, early data shown a day 8, 5% weight loss, but obviously, that's very early. So we will update those data later this year. This is an important combination for us because we believe with this combination, we can have best-in-class efficacy with a monthly dosing, which will be highly differentiated for this combination.

    先前,早期數據顯示第 8 天體重減輕了 5%,但顯然,這只是非常早期的結果。因此,我們將在今年稍後更新這些數據。這對我們來說是一個重要的組合,因為我們相信透過這種組合,我們可以實現一流的療效,每月一次給藥,這將是該組合的顯著優勢。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Chris. And now it's time for the last question.

    謝謝你,克里斯。現在到了最後一個問題。

  • Operator

    Operator

  • Louise Chen, Scotiabank.

    Louise Chen,加拿大豐業銀行。

  • Louise Chen - Analyst

    Louise Chen - Analyst

  • Hi. Thanks for taking my questions. I wanted to ask you first, it's been a couple of years since you completed the acquisition of Seagen. And I'm just curious how that integration has gone? And then how is that deal really increase your leadership in oncology? And then just a second quick question on your PD-1xVEGF. It's becoming a more crowded market. So just curious where you expect to stand out with respect to your pipeline. I mean there's some indications that are coming before you but is there anything special that you would like to call out. Thank you.

    你好。謝謝您回答我的問題。我想先問一下,自從您完成對 Seagen 的收購以來已經過去幾年了。我只是好奇整合進展如何?那麼,這項交易究竟該如何提升您在腫瘤學領域的領導地位呢?然後,關於您的 PD-1xVEGF,我還有一個小問題。市場競爭越來越激烈。所以,我很好奇你認為在你的產品線中,哪些方面能夠脫穎而出。我的意思是,有一些跡象表明某些事情即將發生,但你有什麼特別想強調的嗎?謝謝。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Louise. And clearly Seagen has been integrated on research, commercial, manufacturing and multiple other levels. But given that Chris was the leader that drove the integration during the first sensitive year, Chris, maybe you want to make a comment on how the integration of Seagen went and is continue doing.

    謝謝你,路易絲。顯然,Seagen 已在研發、商業、製造和多個其他層面實現了整合。但鑑於克里斯是第一個敏感年份推動整合的領導者,克里斯,或許你想就 Seagen 的整合進展以及目前的進展發表一些評論。

  • Chris Boshoff - Chief Scientific Officer and President, Research & Development

    Chris Boshoff - Chief Scientific Officer and President, Research & Development

  • Thank you very much for the question. So firstly, we have a vibrant community of scientists and clinicians in Seattle. I believe we're one of the biggest employers for -- in the biotech or biopharma industry in that region. Most of the colleagues actually remained at Pfizer, which is just a testament of our culture and the success of the integration.

    非常感謝您的提問。首先,西雅圖擁有一個充滿活力的科學家和臨床醫生群體。我相信我們是該地區生物技術或生物製藥行業最大的雇主之一。大多數同事實際上都留在了輝瑞公司,這充分證明了我們的企業文化和整合的成功。

  • A number of programs have started and being accelerated, including, as you've seen, the readout with 303 and 304 for PADCEV. We are planning an additional Phase 3 study for PADCEV. It will start later this year. It's an important study for us and for patients because that is to -- study to potentially replace cystectomy, which, as you know, leads to significant morbidity and mortality.

    許多專案已經啟動並正在加速推進,其中包括,正如你所看到的,PADCEV 的 303 和 304 號讀出。我們計劃對 PADCEV 進行額外的 3 期研究。將於今年晚些時候開始。這項研究對我們和患者都非常重要,因為這項研究旨在尋找替代膀胱切除術的方法,而膀胱切除術,正如您所知,會導致嚴重的併發症和死亡。

  • We also accelerated a number of other programs into Phase 3, including SV with two Phase 3 studies ongoing and an additional Phase 3 study that's going to start. PDL1V, another Phase 3 program ongoing in non-small cell lung cancer and a number of Phase 1 ADCs that's differentiated, including using the integrin beta 6 antigen as a marker with new payloads, including TOPO 2 and new orastatin based payload. So integration, overall, of Seagen going very, very well.

    我們也加快了其他一些計畫進入第三階段,包括 SV,目前有兩個第三階段研究正在進行中,還有一項第三階段研究即將開始。PDL1V 是另一個正在進行的非小細胞肺癌 3 期項目,以及一些具有差異化的 1 期 ADC,包括使用整合素 β6 抗原作為標記物,以及新的有效載荷,包括 TOPO 2 和基於新型奧拉司他汀的有效載荷。總的來說,Seagen 的整合進展非常順利。

  • Regarding '4404, it is a differentiated molecule. What we've seen in the preclinical data was a 100-fold increase for the affinity for PD-1 in the presence of VEGF and binding to all isoforms of VEGF-A. It's a preclinical data highly encouraging overall encouraged by the field now. As you know, we've recently seen from China first line non-small cell lung data that was positive. The data we've seen with a combination of '4404 with chemotherapy are highly encouraging.

    關於“4404”,它是一種差異化分子。我們在臨床前數據中看到的是,在 VEGF 存在的情況下,對 PD-1 的親和力增加了 100 倍,並且與 VEGF-A 的所有亞型結合。這是目前該領域普遍感到鼓舞的臨床前數據。如您所知,我們最近從中國獲得了非小細胞肺癌一線治療的積極數據。我們看到的 4404 與化療合併使用的數據非常令人鼓舞。

  • And as we accelerate the program, as you've seen in we started Phase 3 programs already for colorectal cancer. And earlier this year, we'll also start with first-line Phase 3 with non-small cell lung cancer and then endometrial cancer and bladder cancer, including combinations with our ADC portfolio.

    正如你所看到的,隨著我們加快推進該計劃,我們已經啟動了結直腸癌的第三階段項目。今年早些時候,我們還將啟動針對非小細胞肺癌的第一線 3 期臨床試驗,然後是子宮內膜癌和膀胱癌,包括與我們的 ADC 產品組合進行聯合治療。

  • Albert Bourla - Chairman & Chief Executive Officer

    Albert Bourla - Chairman & Chief Executive Officer

  • Thank you, Chris. Very exciting. So thank you very much, everyone. Clearly, I'm very proud of what we achieved in 2025 in multiple horizons. The last piece of the puzzle was revealed today with the fourth quarter results, which were stellar. We beat with a significant margin, revenues and earnings in the phase of the lowest-ever COVID season that generated the lowest ever revenues because of the way that this strain was mild.

    謝謝你,克里斯。太令人興奮了。非常感謝大家。顯然,我對我們在 2025 年在多個領域的成就感到非常自豪。今天公佈的第四季業績揭曉了最後一塊拼圖,業績非常出色。在新冠疫情最嚴重的時期,由於疫情較為溫和,我們實現了收入和利潤的顯著增長,這也是有史以來收入最低的時期。

  • Now we are already in 2026. And this is a pivotal year because it marks the first year of an LOE cycle, but already started this year. And we've been preparing for that for many years with the acquisitions we have done strategic and licensing agreements, while also it was sharpening our focus on the most impactful internal programs. Our US and international commercial organizations have refined models to strengthen leadership with key product portfolios, streamlining and financial discipline are, of course, ongoing priorities.

    現在已經是2026年了。今年是關鍵的一年,因為它標誌著 LOE 週期的第一年,但實際上今年已經開始了。多年來,我們一直在為此做準備,透過收購、策略性收購和授權協議,同時我們也更加專注於最具影響力的內部專案。我們的美國和國際商業組織已經完善了模型,以加強在關鍵產品組合方面的領導地位,當然,精簡流程和財務紀律仍然是持續的優先事項。

  • We will continue strategic investment in future growth and value creation for our shareholders, including by maintaining and over the long term, growing our dividend. Our 2026 strategic agenda is clear, and I'm confident in the progress we will achieve. Thank you for your interest in Pfizer, and we look forward to continuing to share our progress with you in the year ahead.

    我們將繼續進行策略性投資,以實現未來的成長和為股東創造價值,包括維持並長期提高股息。在我們的2026年策略議程很明確,我對我們將取得的進展充滿信心。感謝您對輝瑞的關注,我們期待在未來一年繼續與您分享我們的最新進展。

  • Operator

    Operator

  • Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

    謝謝。今天的會議到此結束。感謝您抽空參與。您現在可以斷開連線了。