輝瑞 (PFE) 2025 Q3 法說會逐字稿

內容摘要

  1. 摘要
    • Q3 2025 營收為 167 億美元,年減 7%,主因 COVID 產品(Paxlovid、Comirnaty)需求下滑;非 COVID 產品營收年增 4%
    • 本季上修並收窄 2025 年度調整後 EPS 指引至 3.00-3.15 美元(原區間未揭露),全年營收指引維持 610-640 億美元不變
    • 盤後市場反應未明確揭露,但管理層強調 EPS 超預期、成本控管佳,並持續強調長期成長動能
  2. 成長動能 & 風險
    • 成長動能:
      • Metsera 併購案有望強化肥胖症治療領域,結合 Pfizer 商業與臨床實力,帶來長期成長
      • 3SBio 授權案補強腫瘤免疫管線,SSGJ-707 於大腸癌、肺癌展現積極臨床數據,預計 2026 年有更多催化劑
      • Braftovi + Mektovi、Padcev、Xtandi 等腫瘤產品線持續推進,帶動新適應症與患者族群擴大
      • Vyndaqel、Nurtec、Padcev、Prevnar、Abrysvo 等核心產品於國際市場維持雙位數成長,疫苗與罕病領域領先地位穩固
    • 風險:
      • COVID 產品(Paxlovid、Comirnaty)需求持續下滑,全年 COVID 收入恐低於原先 90 億美元預期
      • Metsera 併購案面臨 Novo Nordisk 競爭與反壟斷法律挑戰,交易完成具不確定性
      • 美國藥價政策(MFN 協議)2026 年起將帶來稀釋,國際市場定價與報銷壓力升高
      • 3SBio、Metsera 等新交易短期內對 EPS 具稀釋效應,2026 年預計分別稀釋 EPS 0.05 與 0.16 美元
  3. 核心 KPI / 事業群
    • Vyndaqel 家族:全球營收年增 7%,美國持續雙位數需求成長,國際市場患者數年增 40%
    • Nurtec:全球營收年增 22%,美國口服 CGRP 類領導地位,國際市場持續滲透
    • Padcev:全球營收年增 13%,與 pembro 聯合用於膀胱癌標準治療,預計新適應症將擴大患者族群
    • Prevnar(疫苗):國際營收年增 17%,美國因政府採購時點延遲出現年減,成人市場隨新建議擴大
    • Abrysvo(RSV 疫苗):國際營收年增 75%,美國市佔 59%,但進入第三季面臨人口動員挑戰
  4. 財務預測
    • 2025 年營收預估維持 610-640 億美元,非 COVID 產品表現優於預期
    • 2025 年調整後毛利率約 76%,維持中高 70% 區間
    • 製造優化計畫預計 2027 年前累積節省 15 億美元,總體成本重整計畫至 2027 年累積節省 77 億美元
  5. 法人 Q&A
    • Q: Vyndamax 面對新競爭者,市場份額與價格動態如何?Padcev 新適應症對成長有何影響?
      A: Vyndamax 仍為唯一同時顯著降低死亡率與心血管住院的產品,90% 美國覆蓋率,需求強勁但受 IRA 回扣與第三季保險合約影響,預期 Q4 仍有類似動態。Padcev 目前在膀胱癌不同患者群市佔 45-55%,Q2 因整合 Seagen 產品出現一次性庫存調整,預期 Q4 恢復成長,新適應症將擴大 22,000 名患者市場。
    • Q: Metsera 併購案法律進程與反壟斷風險?
      A: 管理層重申 Novo Nordisk 方案違反反壟斷法,FTC 已提前結束 HSR 等候期,將持續採取法律行動。*管理層未具體說明時程
    • Q: 若 Metsera 交易未成,BD 策略與 2026 年 OpEx、稀釋影響?
      A: 公司仍有充足資源持續尋找收購標的,聚焦四大治療領域,2026 年 OpEx 及稀釋影響將於年底給出更明確指引。
    • Q: 製造投資(MFN 協議)與成本效率優先順序?
      A: 兩者皆為策略重點,將同步強化美國產能與全球製造效率,細節將於 2026 年指引時說明。
    • Q: 2025 年 COVID 產品收入能否達到 90 億美元?若未達標,其他產品能否彌補?
      A: 若 COVID 需求持續低迷,全年營收將落在指引區間下緣,EPS 指引已充分去風險,即使 COVID 低於預期仍可達成獲利目標。

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 third-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年第三季財報電話會議。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 - Senior Vice President, Chief Investor Relations Officer

    Francesca DeMartino - Senior Vice President, Chief Investor Relations Officer

  • Good morning, and welcome to Pfizer's earnings call. I'm Francesca DeMartino, Chief Investor Relations Officer. On behalf of the Pfizer team, thank you for joining us.

    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。

  • This call is being made available via audio webcast at pfizer.com. Earlier this morning, we released our results for the third quarter of 2025 via a press release that is available on our website at pfizer.com.

    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 年第三季業績,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 Dave Denton, our CFO. Albert and Dave have some prepared remarks, and we will then open the call for questions. Members of our leadership team will be available for the Q&A session.

    今天與我一同出席的有我們的董事長兼執行長 Albert Bourla 博士,以及我們的財務長 Dave Denton。艾伯特和戴夫有一些準備好的演講稿,之後我們將開放提問環節。我們的領導團隊成員將出席問答環節。

  • 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.

    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、我們今天早上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,所有這些內容都可以在輝瑞公司官網 (pfizer.com) 的投資者關係網站上找到。

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

    本次電話會議中的前瞻性陳述存在重大風險和不確定性,僅代表電話會議最初日期的情況,我們不承擔更新或修改任何陳述的義務。接下來,我將把電話交給阿爾伯特。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you, Francesca. Good morning, everyone, and thank you for joining our call. The past few months have been pivotal for Pfizer. We are really excited about our future and confident that we are in a strong position to continue delivering value for patients and our shareholders.

    謝謝你,弗朗西斯卡。各位早安,感謝各位參加我們的電話會議。過去幾個月對輝瑞公司來說至關重要。我們對未來充滿信心,並相信我們有能力繼續為患者和股東創造價值。

  • Our third-quarter performance shows how we continued to execute with discipline and focus even while taking on major strategic efforts. I will discuss highlights, including our agreement with the US government, which has provided greater clarity of our strategic investment in future innovation and growth. Additionally, with our proposed acquisition of Metsera and the progress we have made since closing our licensing agreement with 3SBio and key upcoming catalysts, the strength of our R&D pipeline continues to grow.

    第三季的業績表明,即使在進行重大策略工作的同時,我們依然能夠保持嚴謹和專注的執行力。我將重點介紹一些亮點,包括我們與美國政府達成的協議,該協議使我們對未來創新和成長的戰略投資更加清晰。此外,隨著我們擬收購 Metsera,以及自與 3SBio 達成授權協議以來的進展和即將到來的關鍵催化劑,我們的研發管線實力將繼續增強。

  • Our landmark agreement with the US government was an important milestone because it removes uncertainty on two critical policy fronts. We successfully addressed the administration's call to lower prescription drug costs and align prices with those in other developed countries, and we will have a three-year grace period from certain US tariffs with our commitment to further invest in manufacturing in the US.

    我們與美國政府達成的里程碑協議是一個重要的里程碑,因為它消除了兩個關鍵政策領域的不確定性。我們成功回應了政府降低處方藥成本、使價格與其他已開發國家接軌的號召,並且我們承諾進一步投資美國製造業,因此我們將獲得三年的美國關稅寬限期。

  • Now, I want to address our proposed acquisition of Metsera. We believe that Novo Nordisk offer is illusory and cannot constitute superior proposal under the terms of our merger agreement with Metsera because it violates antitrust laws and there is a higher risk it will never be consummated.

    現在,我想談談我們擬議收購 Metsera 的事宜。我們認為諾和諾德的提議是虛假的,不能構成我們與Metsera合併協議條款下的更優方案,因為它違反了反壟斷法,而且存在更高的可能無法完成的風險。

  • We are encouraged by the US Federal Trade Commission's decision to grant early termination of the HSR waiting period, which is unprecedented during a government shutdown and clears the path to completing this transaction following the Metsera shareholder vote on November 13. With the pending legal action we have taken to enforce and preserve Pfizer's rights under the merger agreement, you understand that we will be limited in the details we can address further during today's call.

    美國聯邦貿易委員會決定提前終止 HSR 等待期,這令我們倍感鼓舞。在政府停擺期間,這是史無前例的,這為在 11 月 13 日 Metsera 股東投票後完成交易掃清了障礙。由於我們已採取法律行動來執行和維護輝瑞公司在合併協議下的權利,您理解,在今天的電話會議上,我們能進一步討論的細節將受到限制。

  • What I can say, it is that our belief in the promise of the Pfizer and Metsera combination is strong and unwavering, we are confident it will create substantial value for shareholders and advance innovation to bring important medicines to patients in the high-growth therapeutic area of obesity. Plus, we believe Pfizer will have distinct advantages in developing and delivering new potential treatments because of our proven scientific and commercial strengths.

    我可以肯定地說,我們對輝瑞和美特賽的合併前景充滿信心,我們堅信這將為股東創造巨大價值,並推動創新,為肥胖症這一高增長治療領域的患者帶來重要的藥物。此外,我們相信,憑藉輝瑞公司在科學和商業方面的雄厚實力,輝瑞在開發和提供新的潛在療法方面將具有明顯的優勢。

  • Our R&D infrastructure has global reach and extensive experience running clinical trials in large populace. Our commercial teams have well-established capabilities in bringing primary care therapies to patients. We have proven we can drive leading clinical commercial and strategic momentum with key cardiovascular brands such as Eliquis, Lipitor, Norvasc, and the Vyndaqel family, and we plan to execute in a similar way with Metsera as we reinvigorate Pfizer's cardio metabolic presence.

    我們的研發基礎設施具有全球覆蓋範圍,並在大規模人群臨床試驗方面擁有豐富的經驗。我們的商業團隊在為患者提供基層醫療服務方面擁有成熟的能力。我們已經證明,我們能夠憑藉 Eliquis、Lipitor、Norvasc 和 Vyndaqel 系列等關鍵心血管品牌,推動領先的臨床商業和戰略發展勢頭,我們計劃以類似的方式對 Metsera 進行推廣,以重振輝瑞在心血管代謝領域的實力。

  • The licensing agreement with 3SBio is another way we have strategically enhanced our pipeline. Encouraging Phase 2 first-line metastatic colorectal cancer efficacy and safety data for SSGJ-707, the PD-1 x VEGF bispecific was shared last month at the European Society for Medical Oncology meeting. Looking ahead, we are excited to present additional clinical data at the upcoming Society for Immunotherapy of Cancer meeting.

    與 3SBio 的授權協議是我們策略性地加強產品線的另一條途徑。上個月在歐洲腫瘤內科學會會議上,分享了 PD-1 x VEGF 雙特異性抗體 SSGJ-707 治療轉移性結直腸癌的二期一線療效和安全性的令人鼓舞的數據。展望未來,我們很高興能在即將舉行的癌症免疫治療學會會議上展示更多臨床數據。

  • We are also encouraged by our discussions with regulators about our plans to unlock the potential of '707 with a robust clinical development progress. As we look forward to executing with '707, Pfizer has distinct advantages. We have deep experience in the development of multi-specific antibody therapeutics and the ability to leverage unique combination regimens that make this promising cancer immunotherapy candidate a strong complement to our oncology portfolio.

    我們與監管機構就如何透過強有力的臨床開發進展來釋放「707」的潛力進行了討論,這令我們倍感鼓舞。展望未來,輝瑞公司在執行「707」專案時具有明顯的優勢。我們在開發多特異性抗體療法方面擁有豐富的經驗,並能夠利用獨特的聯合療法,使這種有前途的癌症免疫療法候選藥物成為我們腫瘤產品組合的有力補充。

  • We've also made progress in advancing other key programs in our late-stage R&D pipeline. This was reinforced by our presence at ESMO last month, with over 45 abstracts, five late-breaking presentations, and recognition in Presidential Symposium. Starting with the Presidential Symposium, new Phase 3 data demonstrate that Padcev, in combination with pembrolizumab, reduced the risk of recurrence and death by at least half for patients with cisplatin-ineligible muscle invasive bladder cancer when given before and after surgery.

    我們在推動後期研發管線中的其他關鍵項目方面也取得了進展。上個月我們在 ESMO 的亮相進一步印證了這一點,我們提交了 45 篇摘要,做了 5 場最新研究成果報告,並在主席研討會上獲得了認可。從總統研討會開始,新的 3 期數據顯示,對於不適合接受順鉑治療的肌肉層浸潤性膀胱癌患者,在手術前後給予 Padcev 與 pembrolizumab 聯合治療,可使復發和死亡風險降低至少一半。

  • This is the first and only regimen to improve survival when used before and after standard of care in this patient population. With this unprecedented data in hand, we see the potential to substantially increase the US addressable population with approximately 18,000 patients under the current label in metastatic urothelial cancer. And if there are further positive data and it is approved, up to approximately 22,500 additional patients across both cis-eligible and cis-ineligible muscle invasive bladder cancer.

    這是目前唯一一種在對該患者族群進行標準治療前後使用,能夠提高存活率的治療方案。憑藉這些前所未有的數據,我們看到了大幅增加美國潛在目標族群的潛力,目前該藥物已覆蓋約 18,000 名轉移性尿路上皮癌患者。如果獲得進一步的積極數據並獲得批准,則將為大約 22,500 名符合順式治療條件和不符合順式治療條件的肌肉浸潤性膀胱癌患者提供治療。

  • We also presented follow-up results from the PHAROS single-arm Phase 2 clinical trial supporting Braftovi + Mektovi as a standard of care for patients with metastatic non-small cell lung cancer harboring BRAF V600E mutation. This updated analysis showed a substantial median overall survival benefit of 47.6 months in treatment-naive patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.

    我們也展示了 PHAROS 單臂 2 期臨床試驗的後續結果,該試驗支持 Braftovi + Mektovi 作為攜帶 BRAF V600E 突變的轉移性非小細胞肺癌患者的標準治療方案。這項更新的分析顯示,對於未接受過治療的、攜帶 BRAF V600E 突變的轉移性非小細胞肺癌患者,中位總存活期顯著延長了 47.6 個月。

  • We are pleased with the continued strong year-over-year growth of Braftovi + Mektovi with a 30 percentage point increase in new patient starts since the October '23 launch. We believe the results from the PHAROS trial could establish a new benchmark with targeted combination therapies for its population of patients.

    我們很高興看到 Braftovi + Mektovi 繼續保持強勁的同比增長,自 2023 年 10 月推出以來,新患者數量增長了 30 個百分點。我們相信,PHAROS 試驗的結果可以為該患者群體的標靶聯合療法樹立新的標竿。

  • These results fortify the strength of our growing lung cancer portfolio that includes small molecules, ADCs, and our '707 bispecific. We are confident in our potential to deliver treatments across the lung cancer spectrum, a large and growing market expected to reach approximately $70 billion by year 2030.

    這些結果鞏固了我們不斷壯大的肺癌產品組合的實力,其中包括小分子、抗體藥物偶聯物 (ADC) 和我們的 '707 雙特異性抗體。我們有信心為肺癌的各個方面提供治療方案,這是一個龐大且不斷增長的市場,預計到 2030 年將達到約 700 億美元。

  • We also presented final overall survival results from the Phase 3 EMBARK trial evaluating Xtandi in combination with leuprolide and as a monotherapy in nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. As the first and only ARI-based regimen to demonstrate overall survival benefit in this population, these results highlight the potential benefit of Xtandi in this earlier line treatment setting.

    我們也發表了 3 期 EMBARK 試驗的最終總生存期結果,該試驗評估了 Xtandi 與亮丙瑞林聯合治療以及作為單藥療法治療非轉移性激素敏感性前列腺癌(伴有高風險生化復發)的療效。作為第一個也是唯一一個在該族群中證實總存活獲益的基於 ARI 的治療方案,這些結果突顯了 Xtandi 在早期治療環境中的潛在益處。

  • This strengthens our position for a product that is experiencing strong demand growth in hormone-sensitive prostate cancer and a rapid uptake in the approximate 16,000 US patient population with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.

    這鞏固了我們產品在荷爾蒙敏感性前列腺癌領域的需求強勁增長,並且在美國約 16,000 名患有非轉移性激素敏感性前列腺癌且具有高風險生化復發的患者群體中迅速普及。

  • I want to mention another update about our program in sickle cell disease. We are very pleased that last month, the FDA concluded that Pfizer may resume enrollment of osivelotor studies outside of sub-Saharan Africa and in individuals who have not relocated from sub-Saharan Africa.

    我想再提一下我們鐮狀細胞疾病計畫的最新進展。我們非常高興地得知,上個月,FDA 得出結論,輝瑞可以恢復在撒哈拉以南非洲以外地區以及未從撒哈拉以南非洲遷居的個體中招募奧西洛托研究受試者。

  • We are still engaging with regulatory authorities to determine possible next steps for Oxbryta. We look forward to sharing more details in the months ahead about our key pipeline catalysts for 2026 in the coming years.

    我們仍在與監管機構溝通,以確定 Oxbryta 的下一步可能措施。我們期待在未來幾個月內分享更多關於我們2026年關鍵專案推進計畫的細節。

  • With disciplined execution and our continued focus on key products, both in the US and key international markets, we continue to build on our leadership position within our commercial portfolio. Our Vyndaqel family of products achieved 7% year-over-year global operational growth in the quarter.

    憑藉嚴謹的執行力和對美國及主要國際市場關鍵產品的持續關注,我們不斷鞏固在商業產品組合中的領先地位。本季度,我們的 Vyndaqel 系列產品實現了 7% 的全球營運年增率。

  • Strong demand reinforced that this is the foundation of treatment for patients with the heart condition of ATTR cardiomyopathy, helping them live longer and avoid hospitalization. We are encouraged by our continued strong market leadership.

    強烈的需求表明,這是治療 ATTR 心肌病變患者的基礎,可以幫助他們延長壽命並避免住院。我們持續維持強勁的市場領導地位,這令我們倍感鼓舞。

  • In International, we achieved 40% growth in the quarter in total patients on treatment. In the US, our continued double-digit demand growth reflects strong diagnostic efforts, broad access, and favorable affordability dynamics.

    在國際市場,本季接受治療的患者總數增加了 40%。在美國,我們持續兩位數的需求成長反映了強有力的診斷工作、廣泛的普及以及有利的可負擔性。

  • Nurtec continues to lead with the oral -- to lead the oral CGRP class in primary care penetration in the US. In international, we achieved growth with continued strong uptake in key markets. Globally, we achieved 22% year-over-year operational growth in the quarter. We are pleased that our new consumer campaigns continue to perform well and our team has been effective in sharing new compelling clinical data with healthcare profession.

    Nurtec 繼續引領口服藥物的發展—在美國初級保健領域引領口服 CGRP 類藥物的滲透。在國際市場,我們在主要市場持續強勁成長,實現了業務成長。本季度,我們全球業務實現了同比增長 22% 的營運成長。我們很高興看到新的消費者推廣活動持續取得良好效果,我們的團隊也有效地與醫療保健專業人員分享了新的、引人注目的臨床數據。

  • Padcev, another market leader in our portfolio, achieved 13% year-over-year global operational growth in the quarter. Padcev, in combination with pembro, continues to expand utilization and has been established as a standard of care first-line treatment for patients with locally advanced metastatic urothelial cancer.

    Padcev 是我們投資組合中的另一個市場領導者,該季度全球營運年增 13%。Padcev 與 pembro 聯合使用,其應用範圍不斷擴大,並已成為局部晚期轉移性尿路上皮癌患者的一線標準治療方案。

  • Our vaccines portfolio is a key area of focus in international markets. We are pleased with the strong performance of the Prevnar family, driven by share gains and launches in several key markets. We achieved 17% year-over-year international operational growth in the quarter.

    我們的疫苗產品組合是我們在國際市場上的重點領域。我們對Prevnar系列產品的強勁表現感到滿意,這得益於市場佔有率的成長以及在幾個關鍵市場的上市。本季我們實現了國際業務年增 17%。

  • Pfizer is the pediatric pneumococcal vaccination leader with public funding secured in about 140 national immunization programs around the world. After launching in the majority of key international markets, Prevenar Adult is the established leader among adult pneumococcal conjugate vaccines.

    輝瑞是兒科肺炎球菌疫苗領域的領導者,在全球約 140 個國家免疫規劃中獲得公共資金支持。在大多數主要國際市場推出後,Prevenar Adult 已成為成人肺炎鏈球菌結合疫苗的領導者。

  • In the US where we did experience a year-over-year decline in the quarter, we are pleased with the overall performance of Prevnar 20. For adults, Prevnar held a market-leading position and grew with the expanded recommendation for adults over 50. In the pediatric market, accounting for about 60% of Prevnar revenues in the US, we experienced a delayed timing of government bulk order, which we have seen from time to time. So it's a question of time.

    在美國,雖然本季同比有所下降,但我們對 Prevnar 20 的整體表現感到滿意。對於成年人來說,沛兒疫苗佔據了市場領先地位,隨著對 50 歲以上成年人的推廣,其市場份額也隨之增長。在美國,兒科市場約佔 Prevnar 收入的 60%,我們遇到了政府大量訂單延遲的情況,這種情況我們時不時會遇到。所以這只是時間問題。

  • I want to provide an update about the next-generation PCV program. While we previously guided to a Phase 3 start of our adult 25-valent program in 2025, we are planning to start the study next year if the FDA aligns with our approach. For our pediatric program, we expect fourth-dose data from our ongoing Phase 1/2 study early next year and pending positive data and regulatory feedback, we have the potential to start both Phase 3 programs in 2026, streamlining our development approach and aligning with our strategy to provide a single vaccine across age groups.

    我想向大家介紹下一代和平工作隊志工計畫的最新進展。雖然我們之前預計成人 25 價疫苗計畫將於 2025 年啟動 3 期臨床試驗,但如果 FDA 同意我們的方法,我們計劃明年就開始這項研究。對於我們的兒科項目,我們預計明年年初將獲得正在進行的 1/2 期研究的第四劑數據,如果數據積極並獲得監管部門的反饋,我們有可能在 2026 年啟動兩個 3 期項目,從而簡化我們的開發方法,並符合我們為所有年齡段人群提供單一疫苗的戰略。

  • We are committed to maintaining leadership in the PCV space. And as a reminder, our 25-valent vaccine candidate has the potential for improved immunogenicity for serotype 3, which is one of the largest remaining contributors of pneumococcal disease. Serotype 3 alone is estimated to close approximately 20% of invasive disease in the 65-plus population in the US and EU.

    我們致力於保持在和平工作隊領域的領先地位。再次提醒大家,我們的 25 價候選疫苗有可能提高 3 型肺炎鏈球菌的免疫原性,而第 3 型肺炎鏈球菌是目前肺炎鏈球菌疾病的主要致病菌之一。據估計,僅血清型 3 就可導緻美國和歐盟 65 歲以上人口中約 20% 的侵襲性疾病。

  • Abrysvo also achieved significant international momentum with 75% year-over-year operational growth in the quarter due to expanded access in key markets. In the US, we are experiencing the headwind of a more difficult to activate population as we enter the third season of RSV. Still, we are continuing to strengthen our position with a 59% market share in the US in shipped-dose volume in this quarter.

    由於在主要市場的拓展,Abrysvo 在本季度實現了顯著的國際成長勢頭,營運年增 75%。在美國,隨著 RSV 進入第三個流行季,我們正面臨著更難激活人群的不利局面。儘管如此,我們仍在繼續鞏固我們的地位,本季我們在美國疫苗出貨量市佔率達到 59%。

  • From the significant strategic milestones we have achieved in recent months to our solid financial performance during this quarter, we are demonstrating how we are building for long-term value with near-term execution of our 2025 strategic priorities. By committing to focus simplification and leveraging technology across our business, we are accelerating progress and improving productivity.

    從近幾個月來我們取得的重大策略里程碑,到本季穩健的財務業績,我們正在展示我們如何透過近期執行 2025 年策略重點來建立長期價值。透過致力於簡化流程並在整個業務中運用技術,我們正在加速發展並提高生產力。

  • In the quarter, we achieved another strong gross margin performance. Additionally, we were able to deliver adjusted diluted EPS that was ahead of expectations significantly, even with lower infection rates contributing to a revenue decline in our COVID-19 portfolio. Our business is performing well and we are raising the range of our adjusted diluted EPS guidance for full-year 2025, while also remaining committed to our dividend.

    本季度,我們再次取得了強勁的毛利率表現。此外,即使較低的感染率導致我們的 COVID-19 產品組合收入下降,我們仍然實現了遠超預期的調整後稀釋每股收益。我們的業務表現良好,我們將提高 2025 年全年調整後稀釋每股收益預期範圍,同時我們將繼續致力於派發股息。

  • And with that, I'll turn it over to Dave.

    接下來,我將把麥克風交給戴夫。

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • Thank you, Albert, and good morning, everyone. To begin this morning, I'd like to highlight that our solid financial performance directly reflects our disciplined execution of our key strategic priorities. We continue to prioritize enhanced patient outcomes, as well as the achievement of our financial objectives.

    謝謝你,阿爾伯特,大家早安。首先,我想強調的是,我們穩健的財務表現直接反映了我們對關鍵策略重點的嚴格執行。我們將繼續把提高患者療效和實現財務目標放在首位。

  • Furthermore, our recent agreement with the US government demonstrates our ability to navigate in a complex external environment. Our cost improvement measures have driven greater operational efficiency and streamlined decision-making, which is evident in the solid operating margins for this quarter.

    此外,我們最近與美國政府達成的協議表明我們有能力在複雜的外部環境中游刃有餘。我們採取的成本改善措施提高了營運效率,簡化了決策流程,這在本季穩健的營業利潤率中得到了充分體現。

  • Year-to-date, margins expanded despite the unfavorable impact of the acquired in-process R&D from the 3SBio transaction. Going forward, we expect to improve our cash flow and increase flexibility across our three capital allocation pillars.

    儘管收購 3SBio 交易中的在研研發項目帶來了不利影響,但今年迄今為止,利潤率仍然有所增長。展望未來,我們預期改善現金流,並提高三大資本配置支柱的彈性。

  • Our focus remains on creating long-term shareholder value. We will continue to invest in our business for the long term, evidenced by our recent business development activity while prudently returning capital to our shareholders.

    我們始終專注於創造長期股東價值。我們將繼續對業務進行長期投資,近期業務發展活動證明了這一點,同時謹慎地向股東返還資本。

  • Now with that, let me start with our third-quarter results, and 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 2025 guidance, which continues to improve as we move throughout this year.

    接下來,我將首先介紹我們第三季的業績,然後談談我們的成本改善計劃以及資本配置重點。最後,我想就我們 2025 年的業績指引做一些說明,隨著今年的推進,我們的業績指引也不斷改進。

  • For the third quarter of 2025, we recorded revenues of $16.7 billion, a decrease of 7% operationally versus the same period of last year. That's largely driven by a decline in our COVID products. The decline was primarily due to Paxlovid, which experienced reduced demand from lower levels of disease incidents as well as last year's onetime Paxlovid government stockpiling recorded in Q3 of '24 and, to a lesser extent, Comirnaty. With that said, our non-COVID products performance was solid, growing 4% operationally versus the same period of last year.

    2025 年第三季度,我們的營收為 167 億美元,與去年同期相比,營運收入下降了 7%。這主要是由於我們的新冠產品銷售下降所致。下降的主要原因是 Paxlovid,由於疾病事件減少,其需求下降,以及去年政府在 2024 年第三季記錄的 Paxlovid 儲備,其次是 Comirnaty。儘管如此,我們的非新冠產品業績表現穩健,營運收入比去年同期成長了 4%。

  • On the bottom line, third-quarter 2025 reported diluted earnings per share was $0.62, and adjusted diluted earnings per share was $0.87, ahead of our expectations due to our overall gross margin and cost management performance. I'll point out that this profit performance includes a headwind of approximately $0.20 of acquired in-process R&D from the 3SBio transaction.

    總體而言,2025 年第三季公佈的稀釋後每股收益為 0.62 美元,調整後的稀釋後每股收益為 0.87 美元,由於我們整體的毛利率和成本管理表現,均高於我們的預期。我要指出的是,這項獲利績效包含了從 3SBio 交易中收購的在研發項目帶來的約 0.20 美元的不利影響。

  • Our results demonstrate the effectiveness of our refined commercial strategy. We remain committed to prioritizing key products and markets, optimizing the global allocation of our commercial field resources and concentrating our market efforts on high-priority areas.

    我們的研究結果證明了我們改進後的商業策略的有效性。我們將繼續致力於優先發展重點產品和市場,優化全球商業領域資源的配置,並將市場努力集中在高優先領域。

  • We saw a solid contribution across our product portfolios, primarily driven by Eliquis, Vyndaqel family, and Nurtec, but is more than offset by declines in Paxlovid and Comirnaty. Through the first nine months of '25, Pfizer's recently launched and acquired products delivered $7.3 billion in revenue while growing approximately 9% operationally versus last year.

    我們的產品組合整體表現穩健,主要得益於 Eliquis、Vyndaqel 系列和 Nurtec 的推動,但 Paxlovid 和 Comirnaty 的下滑完全抵消了這些貢獻。2025 年前九個月,輝瑞公司新推出和收購的產品創造了 73 億美元的收入,同時營運收入比去年增長了約 9%。

  • This lower growth rate in the third quarter as compared to Q2 was primarily driven by the timing of pediatric CDC shipments of Prevnar and a onetime favorable impact in Q2 for Seagen products transitioning to a wholesale distribution model in the US. We plan to continue to invest behind these two product groups to drive the future performance and help enable the company to largely offset our LOEs over the next several years.

    第三季成長率低於第二季度,主要是由於美國疾病管制與預防中心兒科疫苗 Prevnar 的出貨時間以及 Seagen 產品在第二季度向美國批發分銷模式過渡所帶來的一次性有利影響所致。我們計劃繼續投資這兩個產品組,以推動未來的業績成長,並幫助公司在未來幾年大幅抵銷我們的支出。

  • Adjusted gross margin for the third quarter was approximately 76%, primarily reflecting the product mix in the quarter and continued strong cost management within our manufacturing footprint. 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.

    第三季調整後毛利率約為 76%,主要反映了本季的產品組合以及我們在生產基地持續強勁的成本控制。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,不包括 Comirnaty,Comirnaty 與我們的合作夥伴 BioNTech 實行 50/50 的利潤分成。

  • We expect $1.5 billion in savings from Phase 1 of the manufacturing optimization program by the end of '27 to support our long-term operating margin expansion goal. Going forward, cost management across our manufacturing network remains a top priority.

    我們預計到 2027 年底,製造優化計畫第一階段將節省 15 億美元,以支持我們長期的營業利潤率擴張目標。展望未來,我們製造網路的成本控制仍然是重中之重。

  • Total adjusted operating expense were $7 billion for the third quarter of '25, an increase of 21% operationally versus LY, driven in large part by the acquired in-process R&D expense for 3SBio. Excluding the 3SBio deal, adjusted operating expenses contracted by approximately $150 million versus last year.

    2025 年第三季調整後的總營運支出為 70 億美元,較上年同期成長 21%,主因是收購 3SBio 的在研研發支出。不計入 3SBio 交易,調整後的營運支出比去年減少了約 1.5 億美元。

  • And looking at the components, adjusted SI&A expenses decreased 3% operationally, primarily driven by focused investments and ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products. Adjusted R&D expenses decreased 3% operationally as well, driven by a net decrease in spending due to pipeline focus and optimization, including the expansion of our digital capabilities. And finally, acquired in-process R&D expenses increased $1.4 billion, largely resulting from the 3SBio deal.

    從組成部分來看,經調整的SI&A費用在營運方面下降了3%,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。經過調整的研發費用在營運方面也下降了 3%,這主要得益於研發管線集中化和優化(包括擴大我們的數位化能力)導致的支出淨減少。最後,收購過程中的研發費用增加了 14 億美元,主要是因為收購 3SBio 所致。

  • As our adjusted SI&A and R&D expenses demonstrate, we continue to be disciplined with our operational expense management. Q3 reported diluted earnings per share was $0.62, and our adjusted diluted earnings per share was $0.87, which benefited from our efficient operating structure. Additionally, EPS was aided by our effective tax rate, primarily driven by favorable changes in jurisdictional mix of earnings and tax benefits related to global income tax resolutions in multiple jurisdictions spanning multiple years, partially offset by the aforementioned 3SBio acquired in-process R&D charge.

    從我們調整後的銷售、管理和研發費用可以看出,我們在營運費用管理方面仍然保持嚴格的紀律。第三季報告的稀釋後每股收益為 0.62 美元,而我們調整後的稀釋後每股收益為 0.87 美元,這得益於我們高效的營運結構。此外,EPS 還受益於我們的有效稅率,這主要得益於收益管轄區組合的有利變化以及與多個司法管轄區跨越多年的全球所得稅解決方案相關的稅收優惠,部分被上述收購 3SBio 的在研研發費用所抵消。

  • We continue to be disciplined with our operational expense management, progressing multiple cost improvement programs as we remain focused on driving operating margin expansion over the coming years. Phase 1 of the Manufacturing Optimization Program contributed savings in the third quarter.

    我們將繼續嚴格控制營運費用,推動多項成本改善計劃,並致力於在未來幾年內擴大營運利潤率。製造最佳化計畫第一階段在第三季實現了成本節約。

  • In addition, we remain on track to deliver on our goal of at least $4.5 billion in cumulative net cost savings from our ongoing cost realignment program by the end of this year. As a reminder, in total for these programs, we expect approximately $7.7 billion in savings by the end of '27 to drive operational efficiencies, strengthening our business with the potential of contributing significantly to our bottom line over this period. Of these savings, approximately $500 million identified in R&D will be reinvested in the pipeline, which we expect by the end of 2026.

    此外,我們仍有望實現今年年底前透過持續的成本調整計畫累計節省至少 45 億美元的淨成本的目標。再次提醒大家,這些專案預計到 2027 年底將節省約 77 億美元,從而提高營運效率,增強業務實力,並有可能在此期間為我們的盈利做出重大貢獻。在這些節省下來的資金中,約有 5 億美元已確定用於研發,我們將把這筆資金重新投入產品線中,預計到 2026 年底即可實現。

  • With that, now let me quickly touch upon our capital allocation strategy which is designed to enhance long-term shareholder value. Our strategy consists of maintaining and growing our dividend over time, reinvesting in our business at the appropriate level of financial returns, and making value-enhancing share repurchases.

    接下來,我將簡要介紹我們的資本配置策略,旨在提升股東的長期價值。我們的策略包括:隨著時間的推移,維持並提高股利;以適當的財務回報水準對我們的業務進行再投資;以及進行提升價值的股票回購。

  • In the first nine months of this year, we returned $7.3 billion to shareholders via our quarterly dividend, invested $7.2 billion in internal R&D, and invested approximately $1.6 billion in business development transactions, primarily reflecting the 3SBio licensing deal. As a reminder, our business development capacity after the 3SBio deal is approximately $13 million.

    今年前九個月,我們透過季度分紅向股東返還了 73 億美元,投資 72 億美元用於內部研發,並投資約 16 億美元用於業務發展交易,主要反映了 3SBio 的許可協議。再次提醒,在完成 3SBio 交易後,我們的業務發展能力約為 1,300 萬美元。

  • In the third quarter, we announced a planned acquisition of Metsera for approximately $4.9 billion with additional contingent value rights tied to successful pipeline progression. The transaction is expected to be funded through a mix of available cash as well as debt.

    第三季度,我們宣布計劃以約 49 億美元收購 Metsera,並附帶與成功推進專案相關的額外或有價值權利。預計此次交易將透過現有現金和債務融資相結合的方式進行。

  • We expect the deal to be dilutive through 2030 as we continue to invest to enable further promising late-stage pipeline assets. Specifically, we currently expect the Metsera transaction to be approximately $0.16 dilutive to 2026 adjusted EPS.

    我們預計到 2030 年,隨著我們繼續投資以推進更多有前景的後期研發項目,交易將稀釋股權。具體而言,我們目前預計 Metsera 交易將使 2026 年調整後每股收益稀釋約 0.16 美元。

  • Additionally, we expect another $0.05 of dilution in '26 from the 3SBio deal, which closed in the third quarter. With that said, we believe the two deals set up a strong potential revenue growth trajectory in 2030 and beyond. And lastly, through the first nine months of '25, operating cash flow was approximately $6.4 billion, which includes the $1.35 billion upfront payment for the 3SBio transaction.

    此外,我們預計 2026 年 3SBio 交易(已於第三季完成)將導致每股盈餘再稀釋 0.05 美元。綜上所述,我們相信這兩項交易將在 2030 年及以後為該公司帶來強勁的潛在收入成長。最後,在 2025 年前九個月,營運現金流約為 64 億美元,其中包括 3SBio 交易的 13.5 億美元預付款。

  • Our gross leverage at the end of the third quarter was approximately 2.7 times. That said, upon the close of the Metsera transaction, our leverage is expected to be above the 2.7 times target. We expect to bring our leverage back down to the target levels over time to continue to support a balanced allocation of capital between reinvestments and direct return to shareholders.

    第三季末,我們的總槓桿率約為 2.7 倍。也就是說,在 Metsera 交易完成後,我們的槓桿率預計將高於 2.7 倍的目標。我們預計隨著時間的推移,槓桿率將回落到目標水平,以繼續支持資本在再投資和直接回報股東之間保持平衡的配置。

  • Now, let me turn to our full-year 2025 guidance. As Albert noted in September, we reached a new voluntary agreement with the US government that will help ensure US patients pay lower prices prescription medications while providing the clarity we need to focus on our business and our investments in future innovation. The agreement has no impact on our 2025 guidance, but we expect a dilutive impact to our 2026 financial outlook.

    現在,讓我來談談我們對2025年全年的業績預期。正如艾伯特在 9 月指出的那樣,我們與美國政府達成了一項新的自願協議,這將有助於確保美國患者支付更低的處方藥價格,同時為我們提供所需的清晰度,以便我們專注於業務和對未來創新的投資。該協議對我們 2025 年的業績指引沒有影響,但我們預計會對我們 2026 年的財務前景產生稀釋性影響。

  • We continue to expect full-year 2025 revenues to be in the range of $61 billion to $64 billion. Non-COVID products continue to perform very well operationally and ahead of our plan. However, we note there is softness in our COVID products due to lower vaccination rates and COVID infection rates. In addition, our guidance assumes a favorable impact to revenues from foreign exchange rates.

    我們仍然預計 2025 年全年營收將在 610 億美元至 640 億美元之間。非新冠相關產品在營運方面繼續表現非常出色,並且超出了我們的計劃。然而,我們注意到,由於疫苗接種率和新冠感染率較低,我們的新冠產品存在疲軟現象。此外,我們的預測假設外匯匯率將對收入產生有利影響。

  • Furthermore, we now expect adjusted R&D to be in the range of $10 billion to $11 billion and our effective tax rate to be approximately 11%. Additionally, adjusted SI&A remains unchanged. Now, given our strong performance to date and our fourth quarter outlook, including our more efficient cost structure, we are raising and narrowing our full-year 2025 adjusted diluted earnings per share guidance by approximately $0.08 at the midpoint to $3 a share to $3.15 a share. I'd like to emphasize our adjusted diluted earnings per share guidance substantially de-risks the current lower-than-anticipated COVID trends.

    此外,我們現在預計調整後的研發支出將在 100 億美元至 110 億美元之間,實際稅率約為 11%。此外,調整後的SI&A保持不變。鑑於我們迄今為止的強勁表現以及我們對第四季度的展望(包括我們更有效率的成本結構),我們將 2025 年全年調整後稀釋每股收益預期上調並縮小範圍,中位數為每股 3 美元至 3.15 美元,上調幅度約為 0.08 美元。我想強調的是,我們調整後的稀釋每股盈餘預期大大降低了當前低於預期的 COVID 疫情發展趨勢所帶來的風險。

  • In closing, we remain committed to enhancing the value of our product portfolio and advancing innovation to further strengthen our pipeline. With a stronger balance sheet, we plan to continue deploying capital effectively.

    最後,我們將持續致力於提升產品組合的價值,推動創新,以進一步加強我們的產品線。憑藉更穩健的資產負債表,我們計劃繼續有效地部署資本。

  • We aim to boost R&D productivity with digital tools, including AI, prioritize investments in key R&D programs, and to deliver new growth through business development. Furthermore, our performance continues to exceed expectations and deliver strong results even as the incidence of COVID remains low.

    我們的目標是利用人工智慧等數位工具提高研發效率,優先投資關鍵研發項目,並透過業務發展實現新的成長。此外,即使新冠肺炎病例數仍然很低,我們的業績也持續超出預期,並取得了強勁的成果。

  • This consistent performance highlights our resilience and commitment to excellence. Regardless of the challenging external environment, our efforts to enhance cost efficiency and generate improvements in operating margins by driving productivity and optimizing processes.

    這一持續穩定的表現凸顯了我們的韌性和對卓越的追求。儘管外部環境充滿挑戰,但我們仍致力於提高成本效益,並透過提高生產力和優化流程來改善營運利潤率。

  • Lastly, with the recent agreement with the US government, we can now focus on executing our strategy and our strategic priorities across our business to deliver new medicines for patients and enhance long-term shareholder value.

    最後,隨著最近與美國政府達成的協議,我們現在可以專注於執行我們的策略和業務策略重點,為患者提供新藥,並提高股東的長期價值。

  • I'd like to just close by noting that it is our expectation that we'll provide guidance for 2026 most likely by the end of this year. So with that, I'll turn it back over to Albert and we'll begin our question-and-answer session.

    最後我想指出,我們預計最快將在今年底前發布 2026 年的業績指引。那麼,接下來我將把發言權交還給阿爾伯特,我們將開始問答環節。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you, Dave. So operator, please assemble the queue.

    謝謝你,戴夫。操作員,請整理隊列。

  • Operator

    Operator

  • (Operator Instructions) Vamil Divan, Guggenheim Securities.

    (操作員指令)Vamil Divan,古根漢證券。

  • Vamil Divan - Equity Analyst

    Vamil Divan - Equity Analyst

  • I'm going to have to defer the Metsera questions to other analysts, but curious here what you say there. I'll just ask a couple more on the commercial side. So one, Vyndamax obviously, facing more competition there. Surprised to see the performance there was a little sequential declines. So maybe you can just comment on the pricing and market share dynamics you're seeing in that space, obviously, with the new competitors?

    關於Metsera的問題,我得請其他分析師來解答,不過我很好奇你對此有何看法。我再問幾個關於商業方面的問題。所以,Vyndamax顯然面臨更激烈的競爭。出乎意料的是,該項賽事的業績出現了一些連續下滑。那麼,您能否談談您在該領域,尤其是在新競爭對手出現的情況下,所觀察到的價格和市場份額動態?

  • And then similar question on Padcev, obviously, great data that you shared at ESMO. The commercial uptake for the quarter is a little bit less than we thought. So maybe just how you expect most invasive indication, assuming you get that here soon to impact uptake of that program and drive upside towards the numbers right now?

    然後,關於 Padcev 也存在類似的問題,顯然,您在 ESMO 上分享的數據非常棒。本季的商業推廣效果略低於我們的預期。所以,也許你期望最具侵入性的適應症能夠盡快得到應用,從而影響該項目的普及率,並推動目前的數字上漲?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you. Aamir?

    謝謝。阿米爾?

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

    Aamir Malik - Executive Vice President, Chief US Commercial Officer

  • Sure. Vamil, thanks for the question. So let me start with your question on Vynda. And I'll just -- I want to level set a couple of things about Vynda, and then I'll talk about the performance in the quarter. So there's obviously new competition in the category.

    當然。Vamil,謝謝你的提問。那麼,就讓我先回答你關於Vynda的問題吧。我只想先說明一下關於 Vynda 的一些基本情況,然後再談談本季的業績。顯然,這個領域出現了新的競爭者。

  • And it's important to note that Vynda is still the only ATTR-CM product that has statistically significant reductions in both mortality and CV-related hospitalizations together and as a standalone. And it's also the only product where there is a once-daily capsule, placebo-like safety, and near-complete ETR stabilization. We've got 90% access for Vyndamax across the US.

    值得注意的是,Vynda 仍然是唯一一款在降低死亡率和心血管相關住院率方面,無論單獨使用或同時使用,都具有統計意義的 ATTR-CM 產品。而且,它是唯一一款每天只需服用一粒膠囊,具有類似安慰劑的安全性,並且能近乎完全穩定 ETR 的產品。我們在美國擁有 90% 的 Vyndamax 存取權限。

  • Now, with regards to the quarter, there are a couple of different dynamics that are happening. First of all, we saw a very strong demand growth, and that's reinforced by our continued market share leadership, both on a TRx basis, clearly, but also in terms of first-line share.

    至於本季度,目前存在幾種不同的動態。首先,我們看到了非常強勁的需求成長,這一點也得到了我們持續的市場份額領先地位的印證,無論是按交易量計算,還是按一線市場份額計算,都明顯如此。

  • Now that volume growth was offset by two gross-to-net headwinds. One is the IRA manufacturer rebates, which we've talked about before. And the second is what we alluded to last quarter, which is payer contracting that took place in the third quarter.

    現在,銷量成長被兩個毛利淨利不利因素抵消了。其中之一是 IRA 製造商返利,我們之前已經討論過。第二點是我們上個季度提到的,也就是第三季發生的支付方合約簽訂。

  • So Vyndamax is performing exactly where we thought it would and consistent with what we guided. And performance continues to reflect strong diagnosis, broad access, improving affordability dynamics, and that's going to continue to grow our volume.

    所以,Vyndamax 的表現完全符合我們的預期,也與我們指引的方向一致。業績持續成長,反映了診斷能力的提升、覆蓋範圍的擴大以及可負擔性的改善,這些因素將繼續推動我們的業務量成長。

  • We are seeing competition that previews taking some first-line share from treatment-naive patients and Amvuttra has driven minimal switching to date. And as we look forward on Vynda, we'll see some of these dynamics continue into Q4 as well, where we expect continued volume growth, but the two GTN drivers that I described will certainly impact our net sales, but Vynda is performing in the way that we expected.

    我們看到,一些預處理藥物正在從初治患者中搶佔一線市場份額,而迄今為止,Amvuttra 引起的轉換影響微乎其微。展望 Vynda 的未來,我們預計這些動態將在第四季度繼續保持,銷量也將持續成長,但我所描述的兩個 GTN 驅動因素肯定會影響我們的淨銷售額,但 Vynda 的表現符合我們的預期。

  • On your question with regards to Padcev, we're, again, very encouraged by how Padcev is doing. For us, when you look at this through two lenses. First is the [ALI-MUC] population where we currently have about 55% share among cisplatin-ineligible patients and 45% to 50% share among cisplatin-eligible. So there is headroom for us to continue to focus on that segment of the market.

    關於您提到的帕德切夫的問題,我們再次對帕德切夫的表現感到非常鼓舞。對我們來說,當我們從兩個角度來看這個問題時。首先是 [ALI-MUC] 族群,目前我們在不適合順鉑治療的患者中佔約 55% 的份額,在適合順鉑治療的患者中佔 45% 至 50% 的份額。因此,我們還有空間繼續專注於這部分市場。

  • I think your question with regards to how Padcev performed on consensus is related to the comment that Dave made, which is as part of integrating the Seagen products into the Pfizer portfolio in Q2, we moved from a drop ship model to a wholesaler model.

    我認為你關於 Padcev 在共識中的表現的問題與 Dave 的評論有關,Dave 的評論是,作為將 Seagen 產品整合到輝瑞產品組合中的一部分,我們在第二季度從直接發貨模式轉向了批發商模式。

  • So that resulted in a onetime growth in our Q2 sales. So you have to grow products off of that adjusted for two to three weeks of inventory. So as we cycle into Q4, we expect the whole Seagen portfolio, including Padcev to return to growth.

    因此,我們第二季的銷售額出現了一次性成長。所以你必須根據兩到三週的庫存量來調整產品產量。因此,隨著我們進入第四季度,我們預計包括 Padcev 在內的整個 Seagen 產品組合將恢復成長。

  • And then finally, on MIDC, we're excited about the possibility as a result of both the 303 and also 304 trials that are ongoing, and that will open up a patient population of close to 22,000 patients to help with the next rise in Padcev growth.

    最後,關於 MIDC,我們對正在進行的 303 和 304 試驗的結果感到興奮,這將為近 22,000 名患者帶來新的希望,從而有助於 Padcev 的進一步增長。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you, Aamir.

    謝謝你,阿米爾。

  • Operator

    Operator

  • Dave Risinger, Leerink Partners.

    Dave Risinger,Leerink Partners。

  • David Risinger - Analyst

    David Risinger - Analyst

  • Congrats on the performance in the quarter. So my question is on Metsera. Could you just comment on the legal process ahead? I know that Pfizer is arguing that Novo's acquisition of Metsera would be anticompetitive. And even if the FTC doesn't allow it, it could be anticompetitive. So could you just talk us through the clock and the process for courts to hear Pfizer's arguments?

    恭喜你們本季業績出色。所以我的問題是關於Metsera的。您能否就接下來的法律程序發表一下看法?我知道輝瑞公司認為諾和諾德收購美賽拉會構成反競爭行為。即使聯邦貿易委員會不允許,這也可能構成反競爭行為。那麼,您能否簡單介紹法院審理輝瑞公司論點的時限和流程?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you, Dave. As I said in my opening comments, it is very difficult for us to start commenting when we have all these legal issues pending, right, as we speak. But I will repeat what I did say, which is an answer to your question, not on the timing, but we don't see how Novo's deal can be superior.

    謝謝你,戴夫。正如我在開場白中所說,在我們面臨這麼多法律問題的情況下,我們很難開始發表評論,對吧?但我會重複我之前說過的話,這是對你問題的回答,不是關於時機的,而是我們看不出 Novo 的交易有什麼優勢。

  • It is an illegal attempt by a foreign company to do an end run around antitrust laws, taking advantage of the government shutdown. What they want to achieve, not to get the products; to destroy them. What they want is to catch and kill an emerging competitor, which is a significant antitrust concern given Novo's dominant market position. So all I can say it is that we are continuing to pursue all legal resources.

    這是外國公司企圖利用政府停擺,非法規避反壟斷法的行為。他們想要達成的目的不是為了獲得產品,而是為了摧毀它們。他們想要抓住並扼殺一個新興的競爭對手,考慮到諾和銳的市場主導地位,這引起了反壟斷的嚴重擔憂。所以我只能說,我們將繼續利用一切法律手段。

  • Thank you. Next question, please.

    謝謝。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

  • I guess just for Albert and Dave, just a quick high-level question on BD. What's the plan if Metsera doesn't work out for some reason? And then second, on 2026, any early framing on guidance pushes and pulls, specifically on how we should think about OpEx with and without Metsera? And then any additional color on how to think about the dilution you mentioned from your recent MFN deal with the Administration?

    我想問 Albert 和 Dave 一個關於 BD 的高層次問題。如果由於某種原因 Metsera 專案失敗了,那有什麼計劃?其次,關於 2026 年,任何關於指導方針的早期框架,特別是關於我們應該如何看待有 Metsera 和沒有 Metsera 的營運支出,都存在著推動和拉動的因素嗎?那麼,對於您最近與政府達成的最惠國待遇協議中提到的稀釋問題,您還有什麼補充說明嗎?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • I will send the question to Dave because there are a lot of financial elements and then if Andrew wants to add something on the BD deal.

    我會把這個問題發給戴夫,因為這涉及到很多財務方面的問題,然後安德魯如果想就 BD 交易補充些什麼的話。

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • Yeah. So maybe we'll start with business development. Obviously, the company has still significant resources to understand and how to deploy successfully transactions to bring science in-house, and we will continue to work aggressively to do so across all of our four therapeutic areas. And we continue to work across the globe to identify potential candidates for acquisition to help bring new and innovative patient medicines to patients. So that's still a very ongoing focused activity for the company.

    是的。所以,或許我們可以從業務拓展開始。顯然,公司仍然擁有大量資源來了解和如何成功運用交易將科學成果納入公司內部,我們將繼續積極努力,在我們所有的四個治療領域實現這一目標。我們將繼續在全球範圍內尋找潛在的收購對象,以幫助為患者帶來新的創新藥物。所以這仍然是公司持續進行的一項重點活動。

  • I think it's probably a little early to talk exactly about 2026. You heard me give a little color in the sense that, clearly, we're making investments today and those investments carry over into '26 and beyond with either Metsera or 3SBio to bring these innovative medicines to market. Those will have a slightly dilutive effect to our operating performance next year. We will then wrap all that together with the puts and takes of '26 when we give guidance by the end of this year.

    我覺得現在談論2026年的具體情況可能還為時過早。你聽我稍微透露了一下情況,很明顯,我們今天正在進行投資,這些投資將延續到 2026 年及以後,透過與 Metsera 或 3SBio 合作,將這些創新藥物推向市場。這些因素將對我們明年的經營業績產生輕微的稀釋作用。然後,我們將把所有這些與 2026 年的買賣情況綜合起來,並在今年年底給予業績指引。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Anything to add on BD, Andrew?

    關於BD還有什麼要補充的嗎,安德魯?

  • Andrew Baum - Executive Vice President, Chief Strategy and Innovation Officer

    Andrew Baum - Executive Vice President, Chief Strategy and Innovation Officer

  • Yeah. I mean, I'd echo what Dave said, we are very active in all geographies, especially in China. You saw the 3SBio, which adds a foundational asset to become the backbone across multiple indications. And the same is true in China and beyond across all the main therapeutic areas. We've increased the size of our team in China, in particular, and we have very active efforts and when we have something to inform you, you'll certainly be the first to know.

    是的。我的意思是,我同意戴夫的說法,我們在世界各地都非常活躍,尤其是在中國。您看到了 3SBio,它增加了基礎資產,成為多種適應症的支柱。在中國乃至世界其他地區,所有主要治療領域的情況都是如此。我們尤其擴大了在中國的團隊規模,並且正在積極努力,一旦有任何消息要通知您,您一定會第一時間知道。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you. Next question, please.

    謝謝。下一個問題。

  • Operator

    Operator

  • Geoff Meacham, Citibank.

    傑夫‧米查姆,花旗銀行。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • I guess one for Albert or Dave. When you look at the manufacturing investments you're making as part of the MFN agreement, relative to the operational cost efficiencies, how would you rank those as priorities? I guess, both seem to have three-year time frames. I'm just trying to get a sense of the incremental dollar and the strategy there.

    我猜其中一個是給艾伯特或戴夫的。當您審視根據最惠國待遇協議進行的製造業投資時,相對於營運成本效率,您會如何對這些投資進行優先排序?我猜,兩者的時間跨度似乎都是三年。我只是想了解這筆增量美元以及相關的策略。

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • Yeah. Clearly, there are important elements of our strategy. We're going to clearly invest in the US from a production perspective. We're working now to work through our plans with the new agreement with the US government on how to effectively deploy our capacity here in the US and further build it out.

    是的。顯然,我們的策略包含一些重要要素。從生產角度來看,我們顯然會在美國進行投資。我們現在正努力根據與美國政府達成的新協議,制定計劃,以有效地在美國部署我們的能力並進一步擴大其規模。

  • So more to come. We will also provide some color to that when we give guidance for 2026. But we will be able to improve our operating -- manufacturing operating infrastructure and, at the same time, invest in manufacturing here at the US. And those two are not necessarily completely in conflict with one another. We'll be able to do both.

    敬請期待更多內容。我們將在發布 2026 年指導方針時對此進行更詳細的說明。但我們將能夠改善我們的營運——製造營運基礎設施,同時投資美國的製造業。而這兩者並非必然完全衝突。我們能夠兩者兼顧。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you. Next question, please.

    謝謝。下一個問題。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    Courtney Breen,Bernstein。

  • Courtney Breen - Equity Analyst

    Courtney Breen - Equity Analyst

  • Thank you so much for answering our questions today. I really wanted to understand and perhaps another question on Metsera but from a different angle; I wanted to understand, in your mind, what factors supported Pfizer in garnering that unprecedented early termination of the waiting period from the US Federal Trade Commission? That would be really helpful.

    非常感謝您今天回答我們的問題。我真的很想了解,或許還可以從另一個角度問一個關於美替拉的問題;我想了解,在您看來,是什麼因素促使輝瑞公司從美國聯邦貿易委員會獲得了前所未有的提前終止等待期的批准?那真的很有幫助。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • I'm not sure I understood the question.

    我不太確定我是否理解了這個問題。

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

    Francesca DeMartino - Senior Vice President, Chief Investor Relations Officer

  • The FTC clearance.

    獲得聯邦貿易委員會的批准。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Why the FTC clearance?

    為什麼需要聯邦貿易委員會的批准?

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

    Francesca DeMartino - Senior Vice President, Chief Investor Relations Officer

  • Are there any factors that drove the early --?

    有哪些因素促成了早期發展?——?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • If there are any factors? No, I think the FTC made their own decision. Of course, they were aware of these questions. So I don't want to speak for them, but they decided that it is appropriate in the middle of a foreign attempt to supervening to just release our deal, which is now clear. So that's all.

    是否存在任何影響因素?不,我認為聯邦貿易委員會已經做出了自己的決定。當然,他們也意識到了這些問題。所以我不想代表他們發言,但他們決定在外國勢力試圖幹預的情況下,公佈我們的協議是合適的,這一點現在已經很清楚了。就這些了。

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • I think it does further demonstrate the strength of our deal and the pathway to clearance and the pathway for us to be able to further develop these products and take them to the marketplace in a very rapid fashion. This is helpful to patients long term, it is helpful to prices long term under our management and our direction with these assets.

    我認為這進一步證明了我們交易的優勢,以及獲得批准的途徑,也為我們進一步開發這些產品並以非常快的速度將其推向市場鋪平了道路。從長遠來看,這對患者有益;從長遠來看,在我們的管理和指導下,這些資產對價格也有幫助。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Yeah. And should not be surprised, right? Because we all understand that's the epitome of antitrust conflict. The entire pipeline of Metsera, it is the entire pipeline of Novo, plus they have a dominant position with the current products that they have. Of course, FTC would worry about that. I don't want to speak for themselves, but it is something that it is -- everybody understands.

    是的。這不足為奇,對吧?因為我們都明白,這就是反壟斷衝突的縮影。Metsera 的整個產品線,也就是 Novo 的整個產品線,再加上他們目前擁有的產品,都佔據了市場主導地位。當然,聯邦貿易委員會會對此感到擔憂。我不想替他們說話,但事情就是這樣——每個人都明白。

  • All right. Next question, please.

    好的。下一個問題。

  • Operator

    Operator

  • Terence Flynn, Morgan Stanley.

    Terence Flynn,摩根士丹利。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Maybe two for me. You've previously talked about ELREXFIO being a key driver for you over the long term. We noticed that MagnetisMM 5 trial was pushed out data into 2026. We know J&J had a similar trial in a similar patient population that just read out. So maybe you could just remind us of any potential differences here in terms of your trial versus their trial and why there might be a difference in timing given they started around the same time?

    也許我有兩個。您之前曾說過,ELREXFIO 是您長期發展的關鍵驅動因素。我們注意到 MagnetisMM 5 試驗的資料公佈時間延後到了 2026 年。我們知道強生公司在類似的患者群體中進行了一項類似的試驗,結果剛剛公佈。所以,您能否提醒我們一下,您的試驗與他們的試驗在時間上可能存在哪些差異,以及考慮到他們開始的時間大致相同,為什麼時間上可能會有所不同?

  • And the second question is just a clarification on Paxlovid dynamics for the quarter. It looks like by our math, price per script went up over last quarter. So just wondering if there's any onetime items that we need to think about here as we think about the trends in the fourth quarter?

    第二個問題只是想澄清一下本季 Paxlovid 的動態情況。根據我們的計算,每張處方的價格似乎比上一季上漲了。所以我想知道,在考慮第四季趨勢時,是否有任何需要考慮的一次性因素?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • All right. Chris?

    好的。克里斯?

  • Chris Boshoff - Executive Vice President, Chief Oncology Officer

    Chris Boshoff - Executive Vice President, Chief Oncology Officer

  • Thanks for the question. So MagnetisMM 5, as you know, is double-class exposed, possibly later this year, beginning next year is an event-driven study. So timing could shift due to events not happening, which we cannot speculate. But as you can imagine, that's often positive if events are not happening in the study. So we'll just continue to follow the events and hopefully report early next year.

    謝謝你的提問。如您所知,MagnetisMM 5 是雙重類別的,可能在今年稍後推出,從明年開始將進行事件驅動型研究。因此,由於某些事件沒有發生,時間可能會有所變化,這是我們無法預測的。但正如你所想,如果研究中沒有發生任何事件,這通常是件好事。所以我們會繼續關注事態發展,希望明年年初能向大家報告。

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • Yeah. And on the Paxlovid question, I don't think there's any material change in price. We have -- maybe there's different channels, mix, and things of that nature, but nothing significant from that standpoint.

    是的。至於 Paxlovid 的問題,我認為價格不會有任何實質變化。我們或許有不同的頻道、組合等等,但從這個角度來看,沒有什麼實質的改變。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you for clarifying, Dave. Let's go to the next question.

    謝謝你的解釋,戴夫。我們來看下一個問題。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    阿卡什‧特瓦里,傑富瑞集團。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • I had a question on your upcoming Phase 3 EZH2 readout in CRPC. I'm surprised the study isn't more prominently flagged given the potential to extend the Xtandi franchise. What drives your confidence that you're getting adequate target exposure after examining some of your food effect studies? And also, what's your expectations around overall survival? Could we see a 20% to 30% benefit here?

    我有一個關於您即將公佈的 CRPC 患者 EZH2 3 期臨床試驗結果的問題。考慮到這項研究有可能延長 Xtandi 的銷售週期,我很驚訝它沒有得到更突出的關注。在考察了一些食物效應研究後,是什麼讓您確信您已經獲得了足夠的目標暴露量?另外,您對整體存活率有何預期?我們能否從中獲得 20% 到 30% 的收益?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Chris, that's for you.

    克里斯,這是給你的。

  • Chris Boshoff - Executive Vice President, Chief Oncology Officer

    Chris Boshoff - Executive Vice President, Chief Oncology Officer

  • Thank you very much for the question. This is another first-in-class internally discovered program, our EZH2 program. We've previously shared randomized data, which we showed significant PFS benefit in all comers and late-line metastatic castration-resistant prostate cancer.

    非常感謝您的提問。這是另一個我們內部首創的程序,即我們的 EZH2 程序。我們先前分享過隨機數據,數據顯示,對於所有患者和晚期轉移性去勢抗性前列腺癌患者,PFS 均有顯著效益。

  • And we now have three Phase 3 studies ongoing. The first one will read out, to your point, is post-abiraterone, metastatic hormone-resistant prostate cancer. And that we expect in the coming months.

    目前我們有三項三期臨床試驗正在進行中。第一個結果正如您所說,是阿比特龍治療後轉移性荷爾蒙抗性前列腺癌。我們預計未來幾個月內將會出現這種情況。

  • We recently also presented data at ASCO, randomized data on the food effect, to your question, which was 875 milligrams twice a day with food. And it showed that the data are comparable with the dose we now use in Phase 3 with reduced GIAEs. So we are confident in the dose that was selected.

    我們最近還在 ASCO 上展示了關於食物效應的隨機數據,以回答您的問題,即每天兩次,每次 875 毫克,隨餐服用。結果表明,該劑量與我們目前在第 3 期臨床試驗中使用的劑量相當,且胃腸道不良事件減少。因此,我們對所選劑量充滿信心。

  • Operator

    Operator

  • Kerry Holford, Berenberg.

    Kerry Holford,貝倫貝格。

  • Kerry Holford - Analyst

    Kerry Holford - Analyst

  • Just on the guidance for this year, you've clearly reiterated the total revenue range of $61 billion to $64 billion. And when you first set out the guidance, you spoke of total COVID-19 sales of around $9 billion for the year.

    僅就今年的業績指引而言,您已明確重申了總收入範圍為 610 億美元至 640 億美元。在您最初發布指導意見時,您曾提到全年 COVID-19 相關銷售額約為 90 億美元。

  • Seeing that you booked just only around -- just over $4 billion year-to-date, just interested in your comments on whether that $9 billion is still achievable for the full year? And if not, what other assets would you call out as likely to fill that gap and give you confidence to reiterate the total sales guidance?

    鑑於您今年迄今為止的預訂量僅略高於 40 億美元,我想聽聽您對全年 90 億美元目標是否仍有可能實現的看法?如果沒有,您認為還有哪些資產可能填補這一缺口,並讓您有信心重申總銷售額預期?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you. Dave, please?

    謝謝。戴夫,拜託?

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • Yes. On the -- you're absolutely right, Kerry, as you pointed out. I would say that to the low end of our guidance range from a revenue perspective would assume that the COVID franchise continues a very modest uptake for the balance of this year, particularly in the US.

    是的。沒錯──正如你所指出的,凱瑞,你說得完全正確。我認為,從收入角度來看,我們預期範圍的下限是假設 COVID 產品線在今年剩餘時間內繼續保持非常溫和的成長,尤其是在美國。

  • However, as you know, the COVID franchise is subject to peaks and valleys. If there happens to be a wave of COVID in the next several months, you can see utilization spike up. So that's why the range is so large.

    但是,正如你所知,新冠疫情的發展是有高峰和低谷的。如果未來幾個月內出現新冠疫情高峰,使用率可能會飆升。所以這就是範圍如此之大的原因。

  • I'll just point out that what we have done with an earnings per share guidance range is we de-risked the COVID franchise with the guidance that we provided, given that if the trends continue, we'll be closer to the low end of that range, and we will still be able to deliver on our earnings commitment.

    我只想指出,我們透過提供的每股盈餘指引範圍降低了新冠疫情相關業務的風險,因為如果目前的趨勢持續下去,我們的預期將更接近該範圍的下限,但我們仍然能夠實現我們的獲利承諾。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you. Very clear, Dave. Let's move to the next question, please.

    謝謝。很清楚了,戴夫。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

  • Just wanted to understand the thought process around the pricing of the GLP-1 and this class of medicines, given that, I mean, even today, there's a news article out there suggesting the price could be $150 or so. So it seems like the price is only going in one direction.

    我只是想了解 GLP-1 和這類藥物的定價思路,因為,我的意思是,即使在今天,還有新聞報道說價格可能在 150 美元左右。所以價格似乎只會朝著一個方向發展。

  • In that case, I mean, how do you justify the price that you're paying to Metsera? And in general, the obesity landscape over time, how do you think about that with this pricing decline for the class?

    在這種情況下,我的意思是,你如何證明你向 Metsera 支付的價格是合理的?總的來說,隨著時間的推移,肥胖問題的整體情況如何?您如何看待課程價格的下降?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Yeah. Thank you. This is also competition, brings prices down. And of course, they try now to restrict competition. But anyway, the -- yes, we -- in our calculations, we have taken into consideration that the prices of GLP-1s probably will start going down. So I don't know what will be announced now. But in our calculations, we took already that into consideration.

    是的。謝謝。這也是競爭的一部分,會降低價格。當然,他們現在也試圖限制競爭。但無論如何——是的,我們——在我們的計算中,我們已經考慮到 GLP-1 的價格可能會開始下降。所以我不知道接下來會宣布什麼。但在我們的計算中,我們已經考慮到了這一點。

  • Thank you, Mohit. Let's go to the next question, please.

    謝謝你,莫希特。我們進入下一個問題吧。

  • Operator

    Operator

  • Alex Hammond, Wolfe Research.

    Alex Hammond,Wolfe Research。

  • Alexandria Hammond - Equity Analyst

    Alexandria Hammond - Equity Analyst

  • Can you elaborate more on the reason for the delay to the initiation of the pivotal trial for the adult 25-valent pneumococcal program? You'd mentioned a caveat of if the FDA aligns with your approach. So has the tenor of the dialogue changed at the FDA? Is there a chance that surrogate endpoints may no longer be approvable?

    能否詳細說明成人25價肺炎鏈球菌疫苗計畫關鍵性試驗啟動延遲的原因?您曾提到一個前提條件,即FDA是否認同您的方法。那麼,FDA內部的對話基調是否發生了變化?替代終點指標是否有可能不再獲得批准?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you very much. Chris?

    非常感謝。克里斯?

  • Chris Boshoff - Executive Vice President, Chief Oncology Officer

    Chris Boshoff - Executive Vice President, Chief Oncology Officer

  • Yeah. Thank you for the question. Across all our vaccine programs, we're obviously working very closely with the FDA and other regulators on the design of the study and also the end point. PCV 25, pending positive data and FDA feedback, we -- as mentioned, we intend to start that study as well as the pediatric 25-valent program next year.

    是的。謝謝你的提問。在我們所有的疫苗項目中,我們顯然都在與 FDA 和其他監管機構密切合作,共同設計研究方案和確定研究終點。PCV 25,在獲得積極數據和 FDA 回饋後,我們——如前所述,我們打算明年啟動該研究以及兒科 25 價疫苗計劃。

  • So it means we will align the pediatric in the adult study. We expect the full dose data from the pediatric study early next year. So that helps us to coordinate the two studies that we'll just make it easier.

    所以這意味著我們將把兒科研究納入成人研究。我們預計將於明年初獲得兒科研究的完整劑量數據。這樣有助於我們協調這兩項研究,使其更加便捷。

  • The 25 vaccine candidate covers 25 serotypes, particular need to point out Serotype 3, which we did before because the vaccine is designed with significantly enhanced immunogenicity against Serotype 3, which currently constitutes up to 20% of infections in the US and the EU. And to continue our leadership, we also continue to study our fifth generation with 30-plus serotypes, which we'll update you on more in 2026. Thank you.

    25 種候選疫苗涵蓋 25 种血清型,尤其需要指出的是血清型 3,我們之前已經指出過,因為該疫苗的設計顯著增強了對血清型 3 的免疫原性,而血清型 3 目前占美國和歐盟感染病例的 20%。為了繼續保持我們的領先地位,我們也將繼續研究擁有 30 多种血清型的第五代疫苗,我們將在 2026 年向您提供更多相關資訊。謝謝。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you, Chris. Operator, the next question, please.

    謝謝你,克里斯。接線員,請問下一個問題?

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    克里斯‧肖特,摩根大通。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Just maybe two MFN questions. First one is bigger picture. As you think about MFN on new launches over time, what are you thinking about this suggesting for international revenues? Is this -- I guess, I could read this as a net positive that you get higher price? I can read as net negative because reimbursement hurdle is going to be tougher at these higher prices? It could be neutral. Just how you envisioned what plays out with international as you signed that deal?

    可能只需要兩個最惠國待遇方面的問題。首先是著眼於大局。隨著時間推移,您對新產品上市的最惠國待遇有何看法?您認為這會對國際收入產生什麼影響?這——我猜——我可以把它理解為淨收益是更高的,因為這樣你就能得到更高的價格?我可以理解為淨負面影響,因為在高價位下,報銷門檻會更高?可能是中立的。當你簽署那份協議時,對國際合作的發展前景是如何想像的?

  • And then the second one is just trying to get a little bit more color on the MFN impact for 2026. I think you mentioned some dilution there. But just any more quantitative metrics you could provide just like how much of a headwind is that for next year?

    第二部分只是想更詳細地分析 MFN 對 2026 年的影響。我想你剛才提到了稀釋的問題。但您能否提供更多量化指標,例如明年面臨的阻力有多大?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Yeah. I'm sorry if I ask Dave to tell you which he will tell you, he will provide guidance at the end of the year. And that will incorporate everything, including that and the other things that you heard us talking. So I don't think you will get more words out of our mouth no matter how much you torture us.

    是的。如果我問戴夫一些他也會告訴你的事情,我很抱歉。他會在年底提供指導。這將包括所有的一切,包括你剛才聽到的我們談論的其他事情。所以我覺得無論你怎麼折磨我們,我們都不會再說任何話了。

  • But on the new launches in international, of course, we are waiting to see how things may play. The price differential is not sustainable. We are speaking about the smaller basket of countries in international that are affected by that.

    當然,對於國際市場的新產品發布,我們還在觀望情況如何。這種價格差異是不可持續的。我們指的是受此影響的國際上較小一部分國家。

  • And with these countries, we are hoping that they will understand that they need to change the way that they price their product going forward. Of course, a little bit help from the US government and USTR through trade negotiations also can make that happen.

    我們希望這些國家能夠明白,他們需要改變未來的產品定價方式。當然,美國政府和美國貿易代表辦公室透過貿易談判提供一些幫助也能促成此事。

  • And my assessment is that Howard Lutnick and the US trade representatives are highly, highly committed to make this go away. So we will see how that plays. But in theoretical, if the prices over there are -- they are not -- we are not agreeing a decent way of pricing our products, clearly, we will not get reimbursement there and to price them to the price that will not affect the US pricing.

    我的評估是,霍華德·盧特尼克和美國貿易代表們非常、非常致力於解決這個問題。所以我們將拭目以待。但理論上講,如果那邊的價格——實際上並非如此——我們沒有就產品定價達成合理的協議,顯然,我們將無法在那裡獲得補償,而且將產品定價到不會影響美國定價的價格。

  • Let's -- thank you. And now let's go to the next question, please.

    謝謝。現在我們進入下一個問題。

  • Operator

    Operator

  • Umer Raffat, Evercore ISI.

    Umer Raffat,Evercore ISI。

  • Umer Raffat - Equity Analyst

    Umer Raffat - Equity Analyst

  • First on Metsera, I realize this is perhaps in the hands of your M&A lawyers and antitrust lawyers. But from an R&D perspective, can we make sure you'll be evaluating all the new data that's imminent? For example, the monthly transition and how the GI tolerability holds as well as even more importantly, the amylin+GLP early combo data.

    首先,關於 Metsera,我知道這可能掌握在你們的併購律師和反壟斷律師手中。但從研發角度來看,我們能否確保您會評估所有即將出現的新數據?例如,每月過渡情況以及胃腸道耐受性如何,更重要的是,胰淀素+GLP早期組合數據。

  • And then separately, I was very intrigued by a Phase 2b trial you guys initiated on an oral drug in atopic derm. Could you confirm if it's a STAT6 inhibitor? And were you able to gauge the magnitude of STAT6 inhibition Phase 1?

    另外,我對你們針對異位性皮膚炎口服藥物所進行的 2b 期試驗非常感興趣。請問它是否是 STAT6 抑制劑?您是否能夠評估 STAT6 抑制第一階段的程度?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Look, on the Metsera, it's easy if they provide us data or if they publicize data. Of course, we will -- we are eager to see that. And we believe it will be positive.

    你看,對於 Metsera 來說,如果他們提供數據或公開數據,那就很容易了。當然會——我們很期待看到那一幕。我們相信結果會是正面的。

  • On the second question, I will ask Chris to comment.

    關於第二個問題,我將請克里斯發表評論。

  • Chris Boshoff - Executive Vice President, Chief Oncology Officer

    Chris Boshoff - Executive Vice President, Chief Oncology Officer

  • Thank you, Umer. To answer your question regarding our I&I portfolio. I just want to check, are you referring to PF-08049820?

    謝謝你,烏默。關於您提出的關於我們I&I產品組合的問題。我只是想確認一下,您指的是PF-08049820嗎?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • I don't think you can run back to (multiple speakers) --

    我覺得你不能跑回去(多位發言者)——

  • Chris Boshoff - Executive Vice President, Chief Oncology Officer

    Chris Boshoff - Executive Vice President, Chief Oncology Officer

  • Okay. So you are correct, that is a STAT inhibitor. I want to point out that we currently have a very differentiated I&I portfolio with at least five molecules in-house discovered and developed, most of these at a significantly accelerated speed, including obviously P40-TL1A which we co-develop -- which is being codeveloped with Roche, which covers IL-12 then IL-23 via P40.

    好的。所以你說得對,那是STAT抑制劑。我想指出,我們目前擁有非常多元化的免疫和免疫產品組合,至少有五種分子是我們自主發現和開發的,其中大多數分子的研發速度都顯著加快,包括我們與羅氏共同開發的 P40-TL1A——它透過 P40 覆蓋 IL-12,然​​後透過 IL-23。

  • Our two trispecifics covering IL-4, IL-13, TSNL-PO, IL-33, both of those now entering Phase 2 for atopic dermatitis and for other TH2-related diseases. LITFULO with the ongoing Phase 3 trial in non-segmental vitiligo, which is a JAK3 tech inhibitor, also differentiated in-house.

    我們的兩種三特異性藥物分別涵蓋 IL-4、IL-13、TSNL-PO、IL-33,目前均進入異位性皮膚炎和其他 TH2 相關疾病的 2 期臨床試驗。LITFULO 正在進行非節段型白斑症的 3 期試驗,它是一種 JAK3 技術抑制劑,也是公司內部的差異化產品。

  • And then the STAT6, early, just entering Phase 2. Could be potentially first-in-class oral. We currently further optimizing dose and formulation and hope to update you on that program in 2026. Thank you.

    然後是 STAT6,早期階段,剛進入第二階段。可能是同類首創的口服療法。我們目前正在進一步優化劑量和配方,並希望在 2026 年向您報告該專案的最新進展。謝謝。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you very much. Next question, please.

    非常感謝。下一個問題。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉,TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Two questions. What does the drug pricing deal with Trump allow Pfizer to do that other companies will not be able to do other than, of course, AstraZeneca?

    兩個問題。與川普達成的藥品定價協議允許輝瑞公司做哪些其他公司(當然,阿斯特捷利康除外)無法做的事情?

  • And secondly, on Metsera, so the data looks more similar than different than competitors and Metsera disclosures haven't been completely transparent raising serious questions. Many other big cap pharmas have passed over Metsera when pursuing other products validating the me-too point.

    其次,就 Metsera 而言,其數據與競爭對手相比相似之處多於不同之處,而且 Metsera 的資訊揭露並不完全透明,這引發了嚴重的質疑。許多其他大型製藥公司在研發其他產品時都忽略了 Metsera,這證實了「me-too」的觀點。

  • Nothing and all this justifies a bidding war or even a protracted legal battle. Is Pfizer's determination to persist underpinned by substantial confidentiality data -- confidential data or simply the desire to be a player in obesity? Or does Pfizer agree with the points that I just said and could it just walk away?

    沒有任何理由引發競購戰,甚至曠日持久的法律訴訟。輝瑞公司堅持不懈的決心是否源自於大量的機密數據──是機密數據,還是只是想在肥胖領域佔有一席之地?或者輝瑞公司是否同意我剛才說的觀點,並可能就此罷休?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you, Steve. On the first one on the drug prices and what we have that other companies may not have. I can't answer because I don't know what the other companies are having. As you know, the discussions are between the Administration and individual companies, which also ensures that there is no antitrust issues.

    謝謝你,史蒂夫。第一個問題是關於藥品價格以及我們擁有的其他公司可能沒有的優勢。我無法回答,因為我不知道其他公司的狀況。如您所知,這些討論是在政府和各個公司之間進行的,這也確保了不會出現反壟斷問題。

  • And also, of course, there are confidential because that's also what the Administration and the agreements portray, that we should keep confidentiality of those. So I know what we are getting. Some of that has been public and some of that is part of the overall very lengthy deal, but I don't know what others will take.

    當然,有些資訊是機密的,因為政府和相關協議也表明,我們應該對這些資訊保密。所以我知道我們會得到什麼。其中一些內容已經公開,另一些內容則包含在非常冗長的整體協議中,但我不知道其他人會接受什麼。

  • On the Metsera, look, we have seen the data. We did extensive due diligence, and we priced the asset into a price that we thought offers tremendous value to the shareholders of Metsera and to shareholders of Pfizer because those assets that we like in our hands, of course, will provide significant competitive adds.

    關於 Metsera,我們已經看到了數據。我們進行了廣泛的盡職調查,並將該資產定價在我們認為對 Metsera 股東和輝瑞股東都具有巨大價值的價格,因為我們喜歡的這些資產當然會顯著增強我們的競爭力。

  • What you see now it is, I repeat, an effort to catch and kill this emerging competitor, which is Pfizer. And to do that by evading the antitrust scrutiny and virtually get control, de facto control of the company as they will become the major shareholder and the major creditor without any regulatory study. So that's all I have to say. And I'm -- we will see how things to go.

    我再說一遍,你們現在看到的,是一場旨在抓住並扼殺這個新興競爭對手──輝瑞──的行動。為了達到這個目的,他們透過規避反壟斷審查,實際上控制了公司,成為主要股東和主要債權人,而無需任何監管調查。這就是我要說的全部。至於我──我們走著瞧吧。

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • Let's move to our next question, please.

    我們進入下一個問題吧。

  • Operator

    Operator

  • Evan Seigerman, BMO.

    埃文·塞格曼,BMO。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • Assuming Metsera closes, what near-term factors must you consider to continue growing the dividend and then delevering, Dave, as you had said? When do you think you may be able to also start to repurchase shares? Or is that less of a priority with all this BD?

    假設 Metsera 倒閉,Dave,正如你之前所說,為了繼續提高股息並降低槓桿率,你必須考慮哪些近期因素?您認為什麼時候可以開始回購股票?或者說,在所有這些BD事件中,這件事的優先順序就沒那麼高了?

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • Evan, very good question. Obviously, you've seen us over the last 1.5 years or 2 years really lean into productivity across our platform. That productivity has allowed us to delever from roughly 4 times to 2.7 times. That's given us increased flexibility to do both business development as well as maintain and grow our dividend over time.

    埃文,問得好。顯然,在過去的1.5到2年裡,您已經看到我們真正致力於提高我們平台上的生產力。生產力的提高使我們的槓桿率從大約 4 倍降至 2.7 倍。這讓我們在開展業務拓展以及維持和提高股利方面擁有了更大的靈活性。

  • That cycle of improvement in productivity is something that we've now embedded in the company. We will continue to do that. We will continue to do that across the enterprise. We will continue to prioritize ourselves from an R&D perspective.

    這種提高生產力的良性循環現在已經融入公司文化中。我們將繼續這樣做。我們將繼續在整個企業範圍內推行這項做法。我們將繼續把研發當作優先事項。

  • Clearly, we have several assets that we think are key to the growth of this company by the end of the decade. We are going to invest behind those assets from a pipeline perspective. And we're going to invest behind the categories of products that we've either acquired and/or recently launched because those will ultimately allow us to offset the LOEs over the next several years. So we'll be able to do all of that.

    顯然,我們擁有幾項我們認為對公司在本世紀末實現成長至關重要的資產。我們將從管道建設的角度對這些資產進行投資。我們將增加對已收購和/或近期推出的產品類別的投資,因為這些最終將使我們能夠在未來幾年內抵消營運成本。所以我們將能夠做到所有這些。

  • Share repurchases is an important lever for us. In the near term, it's not a tool that we're going to use. We have to get the balance sheet back to where we need to be. And we -- again, we have business priorities that come in the forefront of that at this point.

    股票回購對我們來說是一個重要的槓桿。短期內,我們不會使用這種工具。我們必須讓資產負債表恢復到應有的水準。而且,我們——再次強調,目前我們的首要任務是業務。

  • Great question. Thank you.

    問得好。謝謝。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Okay. So now I think let's get the last question.

    好的。那麼現在我們來回答最後一個問題吧。

  • Operator

    Operator

  • Rajesh Kumar, HSBC.

    Rajesh Kumar,匯豐銀行。

  • Rajesh Kumar - Analyst

    Rajesh Kumar - Analyst

  • Two questions, if I may. I appreciate you cannot say a lot about Metsera at this junction. Just from a modeling perspective, if we are thinking of additional balance sheet capacity for deal making, how much capacity would you assume, assuming that you are keeping some capacity away from Metsera at the moment, in 2026 on your own internal budgeting? That would be really helpful.

    請問兩個問題。我知道在這個階段你不能對梅特塞拉說太多。僅從建模的角度來看,如果我們考慮增加資產負債表容量以進行交易,假設您目前將部分容量保留給 Metsera,那麼根據您自己的內部預算,您認為 2026 年的容量是多少?那真的很有幫助。

  • And just on the 3SBio, I appreciate the deal has just closed and some of the trials have just started. When can we expect to see data news flow come out of that deal? Is it more a 2027 event? Or do we have any interim readout or update in '26?

    至於 3SBio,我知道這筆交易剛完成,有些試驗也剛開始。我們何時才能看到有關該交易的數據新聞流?更像是2027年才會發生的事嗎?或者我們在 2026 年會有任何中期報告或更新嗎?

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you. I think Dave can answer the Metsera modeling?

    謝謝。我認為Dave可以回答Metsera建模的問題?

  • David Denton - Executive Vice President, Chief Financial Officer

    David Denton - Executive Vice President, Chief Financial Officer

  • Yeah. So as you think about BD capacity, as I said in my prepared remarks, we have approximately $13 billion of capacity as we enter here into the third quarter. So with that --

    是的。所以,正如我在準備好的演講稿中所說,在考慮BD產能時,我們進入第三季時擁有約130億美元的產能。所以就這樣…--

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Chris, let's understand 3SBio.

    克里斯,我們來了解3SBio。

  • Chris Boshoff - Executive Vice President, Chief Oncology Officer

    Chris Boshoff - Executive Vice President, Chief Oncology Officer

  • Yeah, the data flows. So just a reminder at ASCO 2025, we shared Phase 2 monotherapy or shared by Phase 2 monotherapy data and first-line non-small cell lung cancer showing the overall objective response of 65%. At ESMO, Phase 2 combo data plus chemotherapy, [ZLOXO] modified FOLFOX6 was shown for first-line metastatic -- sorry, metastatic colorectal cancer, and that was showing a response rate of close to 60%.

    是的,數據在流動。因此,提醒一下,在 2025 年 ASCO 會議上,我們分享了 2 期單藥治療數據,以及一線非小細胞肺癌的治療數據,結果顯示整體客觀緩解率為 65%。在 ESMO 會議上,針對第一線轉移性大腸直腸癌(抱歉,是轉移性大腸直腸癌)的 2 期聯合化療數據([ZLOXO] 改良 FOLFOX6)顯示,其緩解率接近 60%。

  • At SITC, we'll provide additional data combination data in lung cancer. You've just seen, we posted two Phase 3 programs starting now, this year, in first-line non-small cell lung cancer and in first-line colorectal cancer. And in the coming weeks, we'll also provide the full development plan to you at an event and that will be -- show the broad -- the breadth and the depth of our clinical development program for '707.

    在 SITC,我們將提供肺癌方面的更多數據組合數據。如您所見,我們今年將啟動兩項 3 期臨床試驗項目,分別針對第一線非小細胞肺癌和第一線大腸直腸癌。在接下來的幾周里,我們還將在一個活動上向您提供完整的開發計劃,這將——展示我們針對 '707 的臨床開發計劃的廣度和深度。

  • Albert Bourla - Chairman of the Board, Chief Executive Officer

    Albert Bourla - Chairman of the Board, Chief Executive Officer

  • Thank you, Chris. So thank you very much all for your attention. We have been successful in achieving a series of significant strategic milestones. We delivered a solid performance during the quarter, and we are confident in our business and that's why we are raising the range of our adjusted diluted EPS. And of course, we maintain our range of revenue despite the lowest COVID right now trends. So thank you for your interest in Pfizer, and I hope you have a wonderful week.

    謝謝你,克里斯。非常感謝大家的關注。我們已成功實現一系列重要的戰略里程碑。本季我們取得了穩健的業績,我們對公司業務充滿信心,因此我們提高了調整後稀釋每股盈餘的預期範圍。當然,儘管目前新冠疫情情勢嚴峻,我們的營收水準仍保持穩定。感謝您對輝瑞的關注,祝您有個美好的一週。

  • Operator

    Operator

  • This does conclude today's program. Thank you for your participation. You may disconnect at any time.

    今天的節目到此結束。感謝您的參與。您可以隨時斷開連線。