施貴寶 (BMY) 2025 Q3 法說會逐字稿

內容摘要

  1. 摘要
    • 本季營收約 122 億美元,Growth Portfolio 銷售年增 17%,Opdivo、Reblozyl、Camzyos、Breyanzi 等多產品帶動成長
    • 上修全年營收指引 7.5 億美元至 475-480 億美元區間,EPS 指引區間收窄至 6.40-6.60 美元(中位數不變)
    • 盤後市場反應未提及,同業對比未明確說明
  2. 成長動能 & 風險
    • 成長動能:
      • Growth Portfolio(成長型產品組合)持續強勁,四大產品年化銷售均超 10 億美元
      • 新藥上市表現佳,Cobenfy 與 Qvantig 推出後持續成長,醫師回饋正面
      • 臨床與法規里程碑頻傳,iberdomide、pumitamig、CD19 NEX-T、Sotyktu 等多項關鍵數據與突破性資格取得
      • 積極併購與授權(如 Orbital Therapeutics、Philochem),強化細胞治療與放射藥物平台
      • 數位與 AI 整合推動營運效率,持續優化成本結構
    • 風險:
      • Legacy Portfolio(舊產品組合)預期全年下滑 15-17%,Revlimid、Pomalyst、Sprycel、Abraxane 等受學名藥衝擊
      • Cobenfy 處於高度競爭且醫師慣性強的市場,需持續教育與推廣
      • 部分關鍵臨床數據(如 ADEPT-2、milvexian、admilparant)尚未揭露,存在不確定性
      • 政策與價格壓力持續,特別是美國與歐洲市場(如 IRA、DTC、價格談判)
  3. 核心 KPI / 事業群
    • 總營收:約 122 億美元,年增(具體百分比未揭露)
    • Growth Portfolio 銷售:年增 17%
    • Opdivo 全球銷售:約 25 億美元,年增 6%
    • Reblozyl 全球銷售:6.15 億美元,年增(美國 +38%,海外 +31%)
    • Breyanzi 全球銷售:3.59 億美元,年增 58%
    • Camzyos 全球銷售:2.96 億美元,年增 88%
    • Eliquis 全球銷售:37 億美元,年增 23%(美國 +29%,海外 +11%)
    • Sotyktu 全球銷售:年增 20%
    • Cobenfy 銷售:4300 萬美元,年初至今 1.05 億美元,處方數穩定成長
  4. 財務預測
    • 全年營收預估上修至 475-480 億美元
    • 全年毛利率預估維持約 72%
    • 全年營運費用預估維持約 165 億美元(較去年淨省 10 億美元)
  5. 法人 Q&A
    • Q: ADEPT-2 臨床進度與信心?ADEPT-1/4 與 ADEPT-2 設計差異?
      A: ADEPT-2 預計年底前揭露結果,對 Cobenfy 發展計畫持續有信心。ADEPT-4 與 2 設計相同,ADEPT-1 為復發預防設計。
    • Q: Cobenfy 美國市場商業推進、報銷進度與處方深度?
      A: Cobenfy 首年表現符合預期,處方數穩定成長,Medicare/Medicaid 覆蓋率近 100%。第二年重點在於擴大醫師處方深度與廣度,並持續教育市場。
    • Q: BioNTech 合作的 pumitamig 與競品 PD-L1 VEGF 雙特異性抗體的競爭態勢?
      A: 對 pumitamig 具成為新標準治療的信心,臨床開發進度快,涵蓋多個腫瘤適應症,目標搶佔市場前兩名。
    • Q: 成本控管與未來幾年毛利率、R&D 投資平衡?
      A: 2025 年結束時成長型產品組合表現強勁,成本控管進展佳,2027 年前有明確 20 億美元節省目標,將持續平衡成長投資與效率。
    • Q: Eliquis 直售(DTC)與 Part D 改革對未來銷售的影響?
      A: Eliquis 直售計畫已啟動,價格較牌價低 40%,詢問度高。Part D 改革後銷售分布更平均,正負影響大致抵銷。

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

  • Welcome to the Bristol-Myers Squibb third quarter 2025 earnings conference call. (Operator Instructions) Please note, this event is being recorded.

    歡迎參加百時美施貴寶2025年第三季財報電話會議。(操作說明)請注意,本次活動正在錄影。

  • I would now like to turn the conference over to Chuck Triano, Senior Vice President and Head of Investor Relations. Please go ahead.

    現在我將把會議交給資深副總裁兼投資者關係主管查克·特里亞諾。請繼續。

  • Chuck Triano - Investor Relations

    Chuck Triano - Investor Relations

  • Thank you, and good morning, everyone. We appreciate you joining our third quarter 2025 earnings call. With me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer; and David Elkins, our Chief Financial Officer. Also participating in today's call is Adam Lenkowsky, our Chief Commercialization Officer. And we welcome Cristian Massacesi, our recently appointed Chief Medical Officer and Head of Global Drug Development.

    謝謝大家,大家早安。感謝您參加我們2025年第三季財報電話會議。今天早上與我一起發表準備好的演講的有:我們的董事會主席兼首席執行官克里斯·博爾納;以及我們的首席財務官大衛·埃爾金斯。我們的首席商業化長 Adam Lenkowsky 也參加了今天的電話會議。我們歡迎 Cristian Massacesi 加入我們,他是我們新任命的首席醫療官兼全球藥物開發負責人。

  • Earlier this morning, we posted our quarterly slide presentation to bms.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll remind everybody that during this call, we will make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date, and we specifically disclaim any obligation to update forward-looking statements even if our estimates change.

    今天早些時候,我們已將季度幻燈片簡報發佈到 bms.com,您可以利用該簡報來跟進 Chris 和 David 的發言。在正式開始之前,我要提醒大家,在本次電話會議中,我們將對公司的未來計畫和前景發表一些構成前瞻性聲明的言論。由於各種重要因素的影響,實際結果可能與這些前瞻性聲明所指出的結果有重大差異,這些因素包括公司向美國證券交易委員會提交的文件中討論的因素。這些前瞻性陳述代表我們截至今日的估計,不應被視為代表我們截至任何未來日期的估計,並且我們明確聲明,即使我們的估計發生變化,我們也沒有義務更新前瞻性陳述。

  • We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com.

    我們也將重點評論我們的非GAAP財務指標,這些指標經過調整,剔除了某些特定項目。某些非GAAP財務指標與最可比較GAAP指標的調節表可在bms.com上查閱。

  • Finally, unless otherwise stated, all comparisons are made from the same period in 2024, and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. All references to our P&L are on a non-GAAP basis.

    最後,除非另有說明,所有比較均以 2024 年同期為基準,銷售成長率將以基本面為基礎進行討論,不包括外匯的影響。所有關於我們損益表的說明均基於非GAAP準則。

  • And with that, I'll hand it over to Chris.

    好了,現在我把麥克風交給克里斯。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks, Chuck. Welcome, and thank you for joining our third-quarter earnings call. Q3 was another strong quarter, reflecting focused execution across the business as we continue to make progress on our plan to position Bristol-Myers Squibb for long-term sustainable growth. Building on the momentum from the first half of the year, we saw continued strong demand across our Growth Portfolio, achieved positive clinical and regulatory milestones and further aligned our cost structure with the needs of our business.

    謝謝你,查克。歡迎各位參加我們的第三季財報電話會議,感謝您的參與。第三季業績表現強勁,反映出公司各部門的專注執行,我們正繼續推進計劃,使百時美施貴寶實現長期可持續增長。延續上半年的發展勢頭,我們的成長型產品組合需求持續強勁,取得了積極的臨床和監管里程碑,並進一步調整了成本結構以適應業務需求。

  • Let me start with a high-level review of our quarterly performance on slide 4. Our growth portfolio delivered another strong quarter, with sales increasing 17% year over year, strengthening the foundation we're building with assets that are early in their life cycle. Growth was driven by multiple products, including our IO portfolio, Reblozyl, Camzyos, and Breyanzi. And due to our strong performance to date, we are again raising our top line guidance and maintaining the midpoint of our bottom-line guidance. David will provide more detail shortly.

    首先,讓我從第 4 張投影片開始,對我們本季的業績進行一個概覽。我們的成長型投資組合又迎來了一個強勁的季度,銷售額年增 17%,鞏固了我們利用處於生命週期早期階段的資產所建構的基礎。成長由多種產品推動,包括我們的 IO 產品組合、Reblozyl、Camzyos 和 Breyanzi。鑑於我們迄今為止的強勁業績,我們再次上調營收預期,並維持利潤預期中位數不變。大衛稍後會提供更多細節。

  • Our two recent launches performed well in Q3. Cobenfy is delivering steady growth as we continue to receive positive feedback from physicians on key indicators, supporting our expectation that this is a meaningful first indication for Cobenfy. Qvantig's launch is also tracking well.

    我們最近推出的兩款產品在第三季表現良好。Cobenfy 正在穩步增長,我們不斷收到醫生對關鍵指標的正面回饋,這印證了我們對 Cobenfy 具有重要意義的首個適應症的預期。Qvantig 的上市進展也十分順利。

  • From a clinical and regulatory standpoint, I want to highlight a few recent updates. On the clinical data side, in our protein degradation platform, the Phase III EXCALIBER study for iberdomide in patients with relapsed or refractory multiple myeloma demonstrated a statistically significant improvement in MRD negativity rates. Now that we have these results in hand, we will be discussing these compelling data and potential paths forward with health authorities. The trial will continue to evaluate PFS, which is expected in 2026.

    從臨床和監管角度來看,我想重點介紹一些最近的更新。在臨床數據方面,我們的蛋白質降解平台針對複發或難治性多發性骨髓瘤患者開展的 III 期 EXCALIBER 研究顯示,iberdomide 在 MRD 陰性率方面有統計學意義上的顯著改善。現在我們已經掌握了這些結果,我們將與衛生部門討論這些令人信服的數據和可能的前進方向。該試驗將繼續評估無惡化存活期(PFS),預計將於 2026 年進行評估。

  • CELMoD have the promise to be a new foundation in the treatment of hematological malignancies. More broadly, our multipronged protein degradation platform has the opportunity to also address solid tumors, initially with our oral androgen receptor ligand-directed degrader, among others.

    CELMoD有望成為血液系統惡性腫瘤治療的新基礎。更廣泛地說,我們的多管齊下的蛋白質降解平台也有機會解決實體腫瘤問題,首先可以透過我們的口服雄激素受體配體導向降解劑等方法進行治療。

  • At the World One conference last month, we presented Phase II data for pumitamig with our partners at BioNTech. The clinical development program is both advancing and broadening for this important asset. Last month, we initiated the pivotal triple-negative breast cancer study and plan to share early data at the San Antonio Breast Cancer Symposium in December. Additionally, pivotal studies for pumitamig and chemotherapy combinations are now initiating in first-line microsatellite stable colorectal cancer and first-line gastric cancer.

    在上個月的世界一號大會上,我們與 BioNTech 的合作夥伴一起展示了 pumitamig 的 II 期數據。針對這項重要資產,臨床開發案正在不斷推進和拓展。上個月,我們啟動了關鍵的三陰性乳癌研究,並計劃在 12 月的聖安東尼奧乳癌研討會上分享早期數據。此外,普米他米和化療聯合治療一線微衛星穩定型大腸直腸癌和第一線胃癌的關鍵性研究現已啟動。

  • This week, we announced encouraging data at the American College of Rheumatology Convergence Conference, which continue to strengthen our conviction behind CD19 NEX-T in autoimmune diseases and Sotyktu in rheumatology. We presented additional follow-up data for CD19 NEX-T in both lupus and scleroderma, have presented the first disclosure of data in myositis. For Sotyktu, the long-term extension data from the Phase II PAISLEY study continues to validate its potential in lupus as we look forward to Phase III results.

    本週,我們在美國風濕病學會大會上發表了令人鼓舞的數據,這些數據進一步增強了我們對 CD19 NEX-T 在自體免疫疾病領域以及 Sotyktu 在風濕病領域應用的信心。我們展示了 CD19 NEX-T 在狼瘡和硬皮症中的後續數據,並首次披露了其在肌炎中的數據。對於 Sotyktu 而言,來自 II 期 PAISLEY 研究的長期擴展數據繼續驗證其在狼瘡治療中的潛力,我們期待 III 期研究的結果。

  • On the regulatory side, we achieved several milestones, which include our potential first-in-class bispecific ADC iza-bren receiving Breakthrough Therapy Designation for previously treated advanced EGFR-mutated non-small cell lung cancer. And earlier this month, the FDA granted Fast Track Designation to our anti-tau antibody for the treatment of Alzheimer's disease currently in a Phase II study with data expected to read out in 2027.

    在監管方面,我們取得了幾個里程碑式的成就,其中包括我們潛在的首創雙特異性 ADC iza-bren 獲得突破性療法認定,用於治療先前接受過治療的晚期 EGFR 突變非小細胞肺癌。本月初,FDA授予我們用於治療阿茲海默症的抗tau抗體快速通道資格,目前正在進行II期研究,預計2027年發表數據。

  • Together, these milestones highlight the potential of our pipeline to both enhance and sustain growth in the outer years by addressing critical areas of unmet need and the importance of advancing these programs quickly and efficiently.

    這些里程碑共同凸顯了我們的研發管線在未來幾年透過解決關鍵的未滿足需求領域來增強和維持成長的潛力,以及快速有效地推進這些專案的重要性。

  • On the business development front, we recently announced we are acquiring Orbital Therapeutics to strengthen our cell therapy franchise where we have industry-leading expertise. This acquisition will add a potential off-the-shelf best-in-class asset, OTX-201, which can be administered in the community setting. This in vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases. We will also gain access to Orbital's differentiated RNA technology platform, which combines various RNA engineering and advanced delivery methods.

    在業務發展方面,我們最近宣布收購 Orbital Therapeutics,以加強我們在細胞療法領域的業務,我們在該領域擁有領先業界的專業知識。此次收購將增加潛在的現成最佳資產 OTX-201,可在社區環境中進行管理。這種體內CAR-T療法代表了一種新的治療方法,可能會重新定義我們治療自體免疫疾病的方式。我們還將獲得 Orbital 的差異化 RNA 技術平台,該平台結合了各種 RNA 工程和先進的遞送方法。

  • In addition, we saw progress with our partner, SystImmune, as we announced that the first patient was treated in the global Phase II/III trial of iza-bren in previously untreated triple-negative breast cancer ineligible for anti-PD-L1 drugs. In August, we closed the previously announced licensing agreement with Philochem for exclusive worldwide rights to OncoACP3, potential best-in-class radiopharmaceutical therapeutic and diagnostic agent with the opportunity to become a breakthrough treatment for prostate cancer.

    此外,我們與合作夥伴 SystImmune 也取得了進展,我們宣布,在 iza-bren 治療先前未接受治療且不適合接受抗 PD-L1 藥物治療的三陰性乳癌的全球 II/III 期試驗中,首例患者已接受治療。8 月,我們與 Philochem 達成了先前宣布的許可協議,獲得了 OncoACP3 的全球獨家權利。 OncoACP3 是一種潛在的同類最佳放射性藥物治療和診斷劑,有機會成為前列腺癌的突破性療法。

  • We continue to be excited about the overall opportunity with radiopharmaceuticals and believe Philochem added to Rayze, offer a transformational platform for cancer treatment.

    我們仍然對放射性藥物的整體機會感到興奮,並相信 Philochem 的加入,加上 Rayze 的實力,將為癌症治療提供一個變革性的平台。

  • In terms of progress, we opened a US manufacturing hub with the ability to deliver Rayze's next-generation radiopharmaceutical therapies directly to patients within just three days of production, a critical advantage due to the short shelf life of RPTs. The facility is currently manufacturing clinical doses of Rayze 101, which is in Phase III clinical trials for GEP-NETs.

    在進展方面,我們開設了一個美國製造中心,能夠在生產後短短三天內將 Rayze 的下一代放射性藥物療法直接交付給患者,這對於 RPT 的保質期較短而言是一個關鍵優勢。該工廠目前正在生產 Rayze 101 的臨床劑量,該藥物正處於治療胃腸胰神經內分泌腫瘤 (GEP-NETs) 的 III 期臨床試驗階段。

  • Moving on to key data catalysts on slide 5. As we've said before, we are entering a data-rich period. We continue to anticipate data readout for ADEPT-2 by the end of this year and have two additional Cobenfy studies in Alzheimer's disease psychosis, both of which are expected to read out next year. We anticipate needing two of these three studies to read out positively to support regulatory approval.

    接下來,請看第 5 張投影片,了解關鍵數據催化劑。正如我們之前所說,我們正進入一個數據豐富的時期。我們繼續預計在今年年底前公佈 ADEPT-2 的數據,並且還有兩項針對阿茲海默症精神病的 Cobenfy 研究,預計這兩項研究的數據將於明年公佈。我們預計這三項研究中需要有兩項結果呈陽性,才能獲得監管部門的批准。

  • The pace of pivotal readouts will accelerate in 2026. As a reminder, over the next 12 to 24 months alone, we expect data for seven new molecular entities and seven meaningful life cycle management opportunities. Among others, we will see data for admilparant and IPF, a fatal lung disease with high unmet need; CELMoD, iberdomide and mezigdomide, which represent a significant step forward in the treatment of multiple myeloma; the broad milvexian program, where we are running three large Phase III trials to address ongoing unmet needs for patients with cardiovascular disease, including an AFIB trial that could potentially open treatment to at least the 40% of AFIB patients not suitable for Factor Xas today; Cobenfy and a broad range of Alzheimer's related neuropsychiatric conditions; and Sotyktu in lupus and Sjögren's.

    2026年,關鍵性結果公佈的速度將會加快。再次提醒大家,光是接下來的 12 到 24 個月內,我們就將獲得 7 個新分子實體的資料和 7 個有意義的生命週期管理機會。我們將看到以下藥物的數據:admilparant 和 IPF(一種致命的肺部疾病,目前存在大量未滿足的醫療需求);CELMoD、iberdomide 和 mezigdomide,它們代表了多發性骨髓瘤治療領域的重大進步;廣泛的 milvexian 項目,我們正在開展三項大型 III 期試驗,以滿足心血管疾病患者持續存在的未滿足醫療需求,其中三項大型 III 期因子抑制劑的 AFIB 患者獲得治療;Cobenfy 和一系列與阿茲海默症相關的神經精神疾病;以及 Sotyktu 在狼瘡和乾燥症候群中的應用。

  • Together, these represent an attractive set of near-term catalysts that can further shape our pipeline and longer-term growth trajectory, given the significant commercial potential of the indications. And looking out a bit further, by the end of this decade, we have the potential to introduce 10 new medicines to the market and at least 30 significant life cycle management opportunities. This strategy is designed to set BMS on a clear path of strong and sustainable growth, which remains our guiding principle.

    鑑於這些適應症具有巨大的商業潛力,這些因素共同構成了一系列有吸引力的近期催化劑,可以進一步塑造我們的產品線和長期成長軌跡。展望未來,到本十年末,我們有可能向市場推出 10 種新藥,並至少有 30 個重要的生命週期管理機會。該策略旨在使 BMS 走上強勁且可持續成長的明確道路,這仍然是我們的指導原則。

  • Beyond the specific commercial and R&D highlights, the company continues to focus on strong financial discipline. Consistent with prior quarters, while we generated significant cash flow in the third quarter, we also continue to be prudent in managing our expenses as we align our cost structure with the projected shape of our business. In addition, we progressed our efforts in the quarter to rewire how we operate, including continuing to integrate digital technology and AI across the company. We anticipate these efforts will drive additional efficiencies going forward and significantly enhance the agility of the organization.

    除了具體的商業和研發亮點之外,該公司繼續專注於嚴格的財務紀律。與前幾季一致,雖然我們在第三季產生了可觀的現金流,但我們也繼續謹慎管理支出,使我們的成本結構與我們業務的預期發展方向保持一致。此外,本季我們推進了營運方式的改革,包括繼續在公司內部整合數位技術和人工智慧。我們預計這些努力將進一步提高效率,並顯著增強組織的敏捷性。

  • So what does this mean? Between our Growth Portfolio performance, the business development activity I just referenced, including the BioNTech partnership and combined with our broad pipeline and strong financial discipline, we feel even better about our longer-term growth potential. I want to take a moment and thank my colleagues around the globe who are committed to our mission to discover, develop, and deliver innovative and life-changing medicines to patients.

    那這意味著什麼呢?結合我們成長型投資組合的表現、我剛才提到的業務發展活動(包括與 BioNTech 的合作),以及我們廣泛的產品線和強大的財務紀律,我們對長期成長潛力更有信心。我想藉此機會感謝全球各地致力於發現、開發和提供創新且能改變患者生活的藥物的同事們。

  • With that, I'll turn it over to David.

    接下來,我將把麥克風交給大衛。

  • David Elkins - Executive Vice President, Chief Financial Officer, Member of the Leadership Team

    David Elkins - Executive Vice President, Chief Financial Officer, Member of the Leadership Team

  • Thank you, Chris, and good morning, everyone. I'm pleased to report another strong quarter of execution. The Growth Portfolio continues to perform well, and we continue to maintain cost discipline.

    謝謝你,克里斯,大家早安。我很高興地報告,本季業績執行情況依然強勁。成長型投資組合持續表現良好,我們也持續保持成本控制。

  • Now turning to the third-quarter sales performance on slide 7. Total company sales were approximately $12.2 billion, which reflects strong demand across our business. Global sales of the Growth Portfolio increased 17%, driven primarily by demand across multiple brands, notably our I/O portfolio, Reblozyl, Camzyos, and Breyanzi.

    現在就來看看投影片 7 的第三季銷售業績。公司總銷售額約 122 億美元,反映出我們各項業務的強勁需求。成長產品組合的全球銷售額成長了 17%,主要得益於多個品牌的需求,特別是我們的 I/O 產品組合、Reblozyl、Camzyos 和 Breyanzi。

  • Beginning with a review of the oncology portfolio on slide 8. Opdivo global sales were approximately $2.5 billion, up 6%, driven primarily by continued demand. In the US, sales grew 6% to roughly $1.5 billion, largely driven by a strong launch in MSI high colorectal cancer and continued share growth in first-line non-small cell lung cancer. This growth was achieved even as we saw expanded uptake of Qvantig.

    首先回顧第 8 張投影片上的腫瘤產品組合。Opdivo全球銷售額約25億美元,成長6%,主要得益於持續的需求。在美國,銷售額成長了 6%,達到約 15 億美元,這主要得益於 MSI 高表達結直腸癌的強勁上市以及一線非小細胞肺癌市場份額的持續增長。即使在 Qvantig 的市場份額不斷擴大的情況下,我們仍然實現了這一增長。

  • Outside the US, sales grew 6%, driven by demand with expanded indications across multiple markets. We are pleased with the expanded growth of Qvantig with sales of $67 million in the quarter. Growth was fueled by continued use Qvantig across all indicated tumor types as well as the permanent J code received in the quarter. Due to the strong performance year to date, we now expect global Opdivo sales together with Qvantig to deliver stronger growth than previously guided, with sales expected to increase in the high single-digit to low double-digit range for the full year.

    在美國以外,受多個市場擴大適應症需求的推動,銷售額成長了 6%。我們對 Qvantig 的持續成長感到滿意,該季度銷售額達到 6,700 萬美元。成長得益於 Qvantig 在所有適應症腫瘤類型中的持續使用,以及本季獲得的永久性 J 代碼。由於今年迄今的強勁表現,我們現在預計 Opdivo 與 Qvantig 的全球銷售額將比之前預期的實現更高的增長,預計全年銷售額將實現高個位數到低兩位數的增長。

  • Turning to our hematology performance on slide 9. Reblozyl's global sales were $615 million in the quarter, reflecting continued strength across our MDS-associated anemia indications. We're annualizing over $2 billion in sales for the brand. In the US, revenue growth continues to be strong, up 38%, primarily due to demand in first-line RS-positive and RS-negative setting as well as improved duration of therapy. Outside the US, Reblozyl sales grew 31%, driven by demand in newly launched markets.

    接下來我們來看第 9 張投影片上的血液學表現。本季 Reblozyl 的全球銷售額為 6.15 億美元,反映出我們在 MDS 相關貧血適應症方面持續強勁的銷售勢頭。該品牌的年銷售額超過 20 億美元。在美國,收入成長依然強勁,成長了 38%,這主要是由於一線 RS 陽性和 RS 陰性治療的需求以及治療持續時間的延長。在美國以外,受新推出的市場需求推動,Reblozyl 的銷售額成長了 31%。

  • Moving to Breyanzi. Sales were $359 million in the quarter and now annualizing over $1 billion. Global sales grew 58%, reflecting strong demand across all indications. In US, sales were $251 million, growing 45%, reflecting growth in large B-cell lymphoma and expansion from new indications approved last year. Outside the US, sales were $109 million, more than doubling due to continued strong demand across existing markets along with added demand from newly launched markets.

    搬到布雷揚齊。本季銷售額為 3.59 億美元,年銷售額超過 10 億美元。全球銷售額成長 58%,反映出所有適應症的強勁需求。在美國,銷售額為 2.51 億美元,成長了 45%,這反映了大 B 細胞淋巴瘤的成長以及去年批准的新適應症的擴大。在美國以外,銷售額為 1.09 億美元,由於現有市場持續強勁的需求以及新推出的市場需求增加,銷售額增長了一倍多。

  • Transitioning to our cardiovascular performance on slide 10, starting with Camzyos. Global sales increased 88% to $296 million, reflecting continued robust demand. This is another asset in our growth portfolio, also now annualizing over $1 billion. In the US, sales were $238 million, up 76% driven primarily by increasing new patient starts. Outside the US, sales growth more than doubled driven by continued launch momentum in multiple markets.

    接下來,我們將從第 10 張投影片開始,介紹心血管效能,首先是 Camzyos。全球銷售額成長 88% 至 2.96 億美元,反映市場需求持續強勁。這是我們成長型投資組合中的另一項資產,目前年化收益也超過 10 億美元。在美國,銷售額為 2.38 億美元,成長 76%,主要得益於新患者數量的增加。在美國以外,受多個市場持續的上市動能推動,銷售額成長超過一倍。

  • Eliquis global sales were $3.7 billion, growing 23%, primarily driven by continued strong demand and the expected favorable impact of Medicare Part D redesign. US sales grew 29% and ex US sales grew 11%.

    Eliquis 全球銷售額達 37 億美元,成長 23%,主要得益於持續強勁的需求以及 Medicare Part D 改革帶來的預期有利影響。美國銷售額成長了 29%,美國以外地區的銷售額成長了 11%。

  • Moving to immunology performance on slide 11. Sotyktu sales grew 20% globally. In the US, sales remained consistent with prior year due to demand being offset by higher rebates associated with our increased commercial access.

    第 11 張投影片將介紹免疫學表現。Sotyktu 全球銷售額成長了 20%。在美國,由於需求下降,加上我們擴大了商業管道,獲得了更高的折扣,因此銷售額與上年持平。

  • Now turning to discuss Cobenfy on slide 12. Cobenfy sales were $43 million in the quarter and $105 million year to date. As previously communicated, sales and weekly total prescriptions continue to grow steadily. We remain focused on disrupting the entrenched D2 prescribing behavior by educating physicians on Cobenfy's innovative profile, and we've completed our field force expansion to increase reach and frequency to targeted health care professionals.

    現在轉到第 12 張投影片討論 Cobenfy。Cobenfy 本季銷售額為 4,300 萬美元,今年迄今的銷售額為 1.05 億美元。正如之前所溝通的那樣,銷售額和每週處方總量繼續穩步增長。我們將繼續致力於透過向醫生普及 Cobenfy 的創新特性來打破根深蒂固的 D2 處方行為,並且我們已經完成了銷售團隊的擴張,以增加對目標醫療保健專業人員的覆蓋範圍和頻率。

  • Now let's move to the P&L on slide 13. Gross margin was approximately 73%, primarily due to product mix. As expected, operating expenses decreased by approximately $100 million to roughly $4.2 billion compared to the same period last year, primarily reflecting the savings from our ongoing strategic productivity initiative. Our effective tax rate in the quarter was 22.3%, reflecting our earnings mix. Overall, diluted earnings per share was $1.63 due to strong performance in the quarter and includes net charges of approximately $530 million or $0.20 per share attributed to acquired in-process R&D and licensing income primarily related to the Philochem asset license and SystImmune milestone payment.

    現在我們來看看第 13 頁的損益表。毛利率約 73%,主要原因是產品組合。正如預期的那樣,與去年同期相比,營運支出減少了約 1 億美元,降至約 42 億美元,這主要反映了我們正在進行的策略生產力提升計畫所節省的資金。本季我們的實際稅率為 22.3%,反映了我們的收益結構。總體而言,由於本季業績強勁,稀釋後每股收益為 1.63 美元,其中包括約 5.3 億美元或每股 0.20 美元的淨費用,這主要歸因於收購的在研研發和許可收入,與 Philochem 資產許可和 SystImmune 里程碑付款有關。

  • Turning to the balance sheet and capital allocation highlights on slide 14. Our financial position remains strong. We generated cash flow from operations of about $6.3 billion in the third quarter with nearly $17 billion in cash, cash equivalents, and marketable securities as of September 30. Our capital allocation priorities remain unchanged as we continue to take a strategic and balanced approach.

    接下來請看第 14 頁投影片上的資產負債表和資本配置要點。我們的財務狀況依然穩健。第三季度,我們的經營活動產生的現金流約為 63 億美元,截至 9 月 30 日,我們擁有近 170 億美元的現金、現金等價物和有價證券。我們將繼續採取策略性和平衡性的方法,因此我們的資本配置優先事項保持不變。

  • As Chris mentioned, in recent months, we closed our license agreement with Philochem, announced the acquisition of Orbital Therapeutics, and advanced our SystImmune in partnership. Strategically investing in our growth portfolio brands along with business development are our top priorities. We also continue to be on track to further delever our balance sheet. As of the end of the third quarter, we have paid $6.7 billion of the $10 billion debt paydown we've committed to by the first half of 2026. And we remain committed to returning capital to our shareholders through the dividend.

    正如 Chris 所提到的,最近幾個月,我們與 Philochem 完成了授權協議,宣布收購 Orbital Therapeutics,並與合作夥伴推進了我們的 SystImmune 專案。策略性地投資於我們的成長型品牌組合以及業務發展是我們的首要任務。我們繼續按計劃推進進一步降低資產負債率。截至第三季末,我們已償還了 2026 年上半年承諾償還的 100 億美元債務中的 67 億美元。我們將繼續致力於透過分紅向股東返還資本。

  • Now turning to our non-GAAP guidance on slide 15. We are increasing our full-year revenue guidance by $750 million at the midpoint to a range of $47.5 billion to $48 billion, primarily reflecting continued strong performance of our Growth Portfolio. We continue to expect the Legacy Portfolio to decline approximately 15% to 17% for the year, and our Revlimid sales expectation remain at approximately $3 billion, along with the continued impacts from generics of Pomalyst in Europe, Sprycel, and Abraxane.

    現在來看第 15 頁的非 GAAP 指引。我們將全年營收預期中位數上調 7.5 億美元,至 475 億美元至 480 億美元之間,主要反映了我們成長型投資組合的持續強勁表現。我們仍預期傳統產品組合今年將下降約 15% 至 17%,我們對瑞復美 (Revlimid) 的銷售預期仍約為 30 億美元,此外,歐洲的 Pomalyst、Sprycel 和 Abraxane 的仿製藥也將持續產生影響。

  • Our gross margin guidance for the year remains unchanged at approximately 72%, and our operating expense guidance also remains unchanged at approximately $16.5 billion, reflecting over $1 billion in net savings versus 2024.

    我們對今年的毛利率預期保持不變,約為 72%;我們的營運支出預期也保持不變,約為 165 億美元,與 2024 年相比,淨節省超過 10 億美元。

  • Regarding OI&E, we now expect annual income of approximately $500 million due to higher-than-anticipated royalties, licensing income, and favorable interest income. We are maintaining our full year tax guidance of approximately 18%.

    關於 OI&E,由於特許權使用費、授權收入和有利的利息收入高於預期,我們現在預計年收入約為 5 億美元。我們維持全年稅率預期在18%左右。

  • As a result of our strong performance year to date, the midpoint of our revised 2025 non-GAAP guidance would have increased by approximately $0.20 per share. This increase was offset by the net impact of acquired in-process R&D charges and licensing income, primarily related to Philochem asset license and a SystImmune milestone payment. As a result, we are narrowing our expected EPS range for 2025 to be between $6.40 and $6.60, which leaves the midpoint of our range unchanged.

    由於我們今年迄今的強勁業績,我們修訂後的 2025 年非 GAAP 指引的中點將增加約 0.20 美元/每股。這一增長被收購過程中研發費用和許可收入的淨影響所抵消,主要與 Philochem 資產許可和 SystImmune 里程碑付款有關。因此,我們將 2025 年的預期每股盈餘範圍縮小至 6.40 美元至 6.60 美元之間,範圍的中點保持不變。

  • Taken all together, I'm pleased with the performance of the business year to date, and I'd like to thank our colleagues around the world for their continued focus and execution.

    總的來說,我對本年度迄今為止的業務表現感到滿意,我要感謝世界各地的同事們持續的專注和執行。

  • With that, I'll turn the call back over to Chuck to start Q&A.

    接下來,我會把電話交還給查克,讓他開始問答環節。

  • Chuck Triano - Investor Relations

    Chuck Triano - Investor Relations

  • Thanks, David. And before we start our Q&A session, I want to note that questions related to our solid tumor development programs will be answered by Adam rather than Cristian during today's call.

    謝謝你,大衛。在我們開始問答環節之前,我想說明一下,今天電話會議上,與我們實體腫瘤開發項目相關的問題將由 Adam 而不是 Cristian 回答。

  • And with that, Betsy, could you please poll for questions?

    那麼,貝齊,你能發起一個投票徵集問題嗎?

  • Operator

    Operator

  • (Operator Instructions) Chris Schott, JPMorgan.

    (操作說明)克里斯‧肖特,摩根大通。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Just I wanted to start with ADEPT-2. Is there any additional updates you can give us in terms of any actions, if any, that you've taken following some of the clinical site reviews you highlighted on the 2Q earnings?

    我只是想從 ADEPT-2 開始。您在2季財報中重點提及了一些臨床試驗點審查結果,請問針對這些結果,您能否提供一些後續進展,例如您已採取的任何行動?

  • And then maybe just putting the broader ADEPT program into context, as we think about ADEPT-1 and 4 next year, can you just talk about the relative confidence you have in those studies relative to ADEPT-2, just given some of the differences in study designs? Just maybe just an update kind of broadly on how you're thinking about that indication. Thank you.

    然後,為了將更廣泛的 ADEPT 項目置於更廣闊的背景下,當我們考慮明年的 ADEPT-1 和 4 時,鑑於研究設計上的一些差異,您能否談談您對這些研究相對於 ADEPT-2 的相對信心?或許可以大致更新一下你對這個指標的看法。謝謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Sure. Thanks for the question, Chris. Maybe I'll start and then obviously, Cristian can chime in with any additional context he has. So just remember, ADEPT-2 is obviously an ongoing study. And it's an ongoing study, as I referenced in my prepared remarks, that has a readout in the next two months. So we're not going to be able to provide a lot of specific comments on the product.

    當然。謝謝你的提問,克里斯。也許我可以先開始,然後克里斯蒂安當然可以補充他所了解的任何額外資訊。所以請記住,ADEPT-2 顯然是一項正在進行的研究。正如我在準備好的演講稿中提到的,這是一項正在進行的研究,將在未來兩個月內公佈結果。因此,我們無法對該產品提供太多具體評論。

  • But what I can say are a few things. First, I will reiterate that we expect results by the end of the year. And of course, we'll communicate those results as we normally do. The second thing I would say, which really gets to the second part of your question is while we remain blinded to the data, our confidence in the Cobenfy development program including an ADP continues to be strong.

    但我可以透露幾點。首先,我要重申,我們預計年底前會取得成果。當然,我們會像往常一樣公佈這些結果。第二點我想說,這其實也切合了你問題的第二部分:雖然我們仍然無法取得數據,但我們對 Cobenfy 開發計畫(包括 ADP)的信心依然很強。

  • And with respect to ADP, I'd just remind you of the source of that confidence. We obviously have compelling external data going back to the Lilly day in the late 90s. We're hearing very interesting real-world stories based on our experience, albeit at schizophrenia. And of course, we have internal data with respect to the ADEPT-1 lead-in and the ADEPT-3 extension data.

    至於ADP,我只想提醒您您信心的來源。我們顯然掌握著令人信服的外部數據,可以追溯到上世紀90年代末的禮來時代。我們根據自身經驗,聽到了許多非常有趣的真實故事,儘管這些故事都與精神分裂症有關。當然,我們也有關於 ADEPT-1 導入資料和 ADEPT-3 擴展資料的內部資料。

  • So that's what I would say about ADEPT-2. But if I step back from the specific studies, remember, the work that we're doing in development fits with the focus that we have on execution really across the company. And given the importance of the late-stage studies, I think it's prudent that we take whatever learnings we can and pull whatever appropriate levers we can to ensure that we deliver these studies with the highest PTS and on time. We're obviously excited to have Cristian on board to bring a fresh perspective to that.

    這就是我對 ADEPT-2 的評價。但是,如果我跳出具體研究的限制,請記住,我們在研發方面所做的工作與我們公司整體上對執行的重視是相符的。鑑於後期研究的重要性,我認為我們應該吸取一切可以學習的經驗教訓,並採取一切適當的措施,以確保我們能夠以最高的 PTS 和按時完成這些研究。我們當然很高興克里斯蒂安加入我們,為團隊帶來全新的視野。

  • So net-net, I feel good about where we are in terms of working through the broader development programs and ensuring that we're executing appropriately. But Cristian, I don't know if you want to add anything.

    總的來說,我對我們目前在推動更廣泛的發展計劃以及確保我們得到適當執行方面所取得的進展感到滿意。但是克里斯蒂安,我不知道你是否還有什麼要補充的。

  • Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

    Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

  • Thanks, Chris. Yeah, let me try to, first of all, reassure that the Cobenfy's development program is progressing really at a rapid pace. We currently have in the development plan 14 studies that are ongoing or in the process to be activated. Ten of those studies are pivotal studies. We actually posted and maybe have seen a study in bipolar mania.

    謝謝你,克里斯。首先,我想向大家保證,Cobenfy 的研發專案進展非常迅速。我們目前的發展計劃中有 14 項研究正在進行或即將啟動。其中十項研究是關鍵性研究。我們之前發文討論過雙極性情感障礙躁症,可能還看過相關的研究。

  • We are also expanding the indications. We plan to initiate pivotal studies in autism spectrum irritability next year. So the program is moving at pace. I think, Chris, you answered very well the reason to believe. I want to add that you -- part of your question was some differences.

    我們也在擴大適應症範圍。我們計劃明年啟動自閉症譜系易激惹的關鍵研究。所以這個項目正在快速推進。克里斯,我認為你很好地回答了相信的理由。我想補充一點,你的問題中有一部分是關於一些差異的。

  • Just to clarify, ADEPT-4 is very similar to ADEPT-2. It's the sister or the brother study. So we are doing the ADEPT-4 exactly in the same patient population with the same primary end point. Then ADEPT-2, as you know, is projected next year.

    需要澄清的是,ADEPT-4 與 ADEPT-2 非常相似。這是姐妹或兄弟研究。因此,我們正在對完全相同的患者群體進行 ADEPT-4 研究,並採用相同的主要終點。如您所知,ADEPT-2 預計明年進行。

  • ADEPT-1 is slightly different because it's a relapse prevention design. This is a trial in which patients are rolling to Cobenfy for 12 weeks. And then at the end of that period, based on the response on the psychosis metrics and CGI, the patient is randomized to Cobenfy and placebo. So different approach but same setting.

    ADEPT-1 略有不同,因為它是一種預防復發的設計。這是一項為期 12 週的 Cobenfy 試驗,患者將輪調使用 Cobenfy。然後,在該階段結束時,根據精神病指標和 CGI​​ 的反應,將患者隨機分配到 Cobenfy 組和安慰劑組。所以方法不同,但背景相同。

  • Operator

    Operator

  • Geoff Meacham, Citi.

    傑夫‧米查姆,花旗銀行。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • Just have a couple also on Cobenfy, but more commercial. How would you guys characterize the speed of reimbursement and maybe the depth of prescribers in the US? I guess I'm just looking for what could be a tipping point of demand as it sounds like maybe there's more work to do on education.

    Cobenfy 上也有幾個,不過更偏商業化一些。你們如何評估美國的藥品報銷速度以及處方醫師的數量和規模?我想我只是在尋找需求的臨界點,因為聽起來教育方面可能還有更多的工作要做。

  • And then also I wanted to loop in Cristian here. I know, obviously, early days. But can you give us a sense of your priorities and maybe approach to development for a diversified portfolio like Bristol? Thank you.

    然後,我還想把克里斯蒂安也拉進來。我知道,現在顯然還為時過早。但您能否讓我們了解一下您對於像布里斯托這樣多元化投資組合的優先事項和發展方法?謝謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Adam, then Cristian.

    先是亞當,然後是克里斯蒂安。

  • Adam Lenkowsky - Chief Commercialization Officer

    Adam Lenkowsky - Chief Commercialization Officer

  • Yeah, yeah. Thanks for the question. So we're pleased with the progress that we've made in Cobenfy's first full year on the market, and we're establishing a new treatment paradigm and what we knew was going to be a highly entrenched market. As you have probably seen, we've now surpassed 2,400 TRxs on a weekly basis and we expect to see continued steady growth. We are adding a significant number of new trialists each week.

    是啊是啊。謝謝你的提問。因此,我們對 Cobenfy 上市第一年的進展感到滿意,我們正在建立一種新的治療模式,我們早就知道這將是一個根深蒂固的市場。正如您可能已經看到的,我們目前的周交易量已超過 2400 TRxs,我們預計未來還將繼續穩定成長。我們每週都會新增大量試用者。

  • Physician feedback continues to be positive regarding Cobenfy's profile, and we're very pleased with the kind of the pace of access that we're able to establish early on. As you know and as a reminder, that this is a heavy Medicare/Medicaid population. And so we have virtually 100% access across both.

    醫生們對 Cobenfy 的評價持續積極,我們對早期就能建立起的這種准入速度感到非常滿意。如您所知,並且再次提醒您,這裡有很多享受聯邦醫療保險/醫療補助的人群。因此,我們在這兩方面都擁有近乎 100% 的存取權限。

  • Now stepping back, there's clearly more work to do in year two. We need to continue to increase both breadth and depth of prescribing, which will drive additional growth for the brand. We've onboarded our expanded field force now in the community and in the hospital setting.

    現在回過頭來看,第二年顯然還有更多的工作要做。我們需要繼續擴大處方範圍和深度,這將推動品牌的進一步成長。我們已將擴大的現場服務隊伍部署到社區和醫院環境。

  • And so based on the leading indicators that we're seeing, Cobenfy is going to deliver continued steady growth in schizophrenia. And longer-term growth is going to be fueled by additional indications as Cristian has stated, and that's what we've also seen with other psychotics in the market. But we are confident that Cobenfy will be a big drug over time. Cristian?

    因此,根據我們目前看到的領先指標,Cobenfy 將在精神分裂症領域實現持續穩定的成長。正如克里斯蒂安所說,更多適應症的出現將推動長期成長,而我們在市場上其他精神類藥物上也看到了這一點。但我們相信,隨著時間的推移,Cobenfy 將會成為一種熱門藥物。克里斯蒂安?

  • Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

    Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

  • Yeah. Geoff, thanks for the question. Let me tell you why I decided to join the BMS beyond the fact that I like Chris. The first thing is the science. BMS always did a very strong science and continue to do it.

    是的。傑夫,謝謝你的提問。除了喜歡克里斯之外,讓我告訴你我加入 BMS 的原因。首先是科學。BMS一直以來都擁有非常強大的科研實力,並且會繼續保持這一優勢。

  • And of course, the portfolio, it's an impressive portfolio across the therapeutic areas with a lot of potential first-in-class and/or best-in-class assets. So this is, of course, the basis. I also like very much the focus that BMS is having in the therapeutic areas where it's playing because beyond oncology and hematology, the focus on immunology, cardiovascular, in neuroscience specifically, those are TAs where you have the intersection, the best intersection of what is the current or the emerging biology rationale and the medical need.

    當然,其產品組合也令人印象深刻,涵蓋各個治療領域,擁有許多潛在的首創或同類最佳資產。這當然是基礎。我也非常欣賞百時美施貴寶 (BMS) 在其所涉足的治療領域所採取的重點,因為除了腫瘤學和血液學之外,免疫學、心血管、神經科學等領域的重點,正是當前或新興生物學原理與醫療需求的最佳交匯點。

  • Of course, the BMS people has always been very highly reputated. I found a very strong development organization here. What I want to do here, what I'm starting to do and going to continue to do is evolve this drug development organization to try to deliver on the pipeline, the short and mid and long-term pipeline, focus on the key strategic priority. I have three main areas where I started to work and will continue to work. The first thing is how we prioritize our ongoing and future opportunities.

    當然,BMS公司一直以來都享有很高的聲譽。我在這裡發現了一個非常強大的發展組織。我在這裡想做的,也是我開始做的,並且將繼續做的,是發展這個藥物研發組織,努力實現研發管線,包括短期、中期和長期管線,專注於關鍵戰略重點。我主要在三個領域開展工作,並將繼續在這些領域工作。首先,我們要考慮的是如何優先考慮當前和未來的機會。

  • Usually, it's a science -- strong science needs to be the basis. So we do execution, flawless execution is incredibly important in development and add value because what we need -- what we do needs to bring value to the patients and, of course, to the company.

    通常來說,這是一門科學——必須以堅實的科學為基礎。因此,我們注重執行,完美的執行在研發過程中至關重要,能夠創造價值,因為我們所做的一切都必須為病患帶來價值,當然,也要為公司帶來價值。

  • The other aspects I'm starting to work with a lot of urgency is integrating new way of working in development. We are at turning point. We cannot continue to do things like what we're doing in the last decades. We have AI. We have a novel solution and tools, and this needs urgently integrating the way we work.

    我現在開始著手處理的另一個迫切問題是,將新的工作方式融入開發工作中。我們正處於轉折點。我們不能再像過去幾十年那樣行事了。我們擁有人工智慧。我們擁有全新的解決方案和工具,亟需將其融入我們的工作方式中。

  • The last thing is people. I need to continue to build the right teams and attract talent in the company.

    最後一點就是人。我需要繼續組建合適的團隊,並吸引優秀人才加入公司。

  • Operator

    Operator

  • Evan Seigerman, BMO Capital Markets.

    Evan Seigerman,BMO資本市場。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • I wanted to touch on the competitive landscape for the PD-L1 VEGF bispecifics. So we saw some data at ESMO with PFS benefit in the HARMONY 6 trial in squamous non-small cell lung cancer. Can you just help frame how that maybe informs how you're thinking about your partnership with BioNTech? Does it make you more incrementally confident? Or is it really too early to read into kind of your program?

    我想談談 PD-L1 VEGF 雙特異性抗體的競爭格局。因此,我們在 ESMO 上看到了 HARMONY 6 試驗中鱗狀非小細胞肺癌的 PFS 獲益數據。您能否簡要說明一下,這會如何影響您對與 BioNTech 合作的看法?它是否讓你逐漸增強了自信?或者現在就對你的專案進行解讀真的為時過早嗎?

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks, Evan. Let me just say one thing about BioNTech and then I'll turn it over to Adam. That partnership continues to go very well. We have a very tight relationship with BioNTech both on the development side and, of course, anticipating the commercial opportunity on the commercial side. And so far, that relationship is quite strong. But Adam, do you want to go through the details?

    謝謝你,埃文。關於 BioNTech,我只想說一句話,然後就把麥克風交給 Adam 吧。雙方的合作進展一直非常順利。我們在研發方面與 BioNTech 保持著非常緊密的合作關係,當然,在商業方面,我們也共同預測商業機會。目前來看,這種關係相當牢固。但是亞當,你想詳細了解嗎?

  • Adam Lenkowsky - Chief Commercialization Officer

    Adam Lenkowsky - Chief Commercialization Officer

  • Sure. Thanks, Chris. And Evan, so we believe that pumitamig has the potential to become a new standard of care. The data that we have seen both from BioNTech as well as from the competitors add to our conviction and broad development program that we have for pumitamig. We have multiple trials that are currently ongoing across several solid tumor indications.

    當然。謝謝你,克里斯。因此,我們相信普米他明有潛力成為新的治療標準。我們從 BioNTech 和競爭對手那裡看到的數據,進一步增強了我們對 pumitamig 的信心,並支持我們廣泛的開發計劃。我們目前正在針對多種實體腫瘤適應症進行多項試驗。

  • As you know, we've got first-line non-small cell lung cancer. We just presented data in small cell lung cancer. And we also have triple-negative breast cancer first-line initiating. We will be presenting TNBC data at San Antonio Breast in December.

    如您所知,我們目前治療的是一線非小細胞肺癌。我們剛剛展示了小細胞肺癌的數據。我們也有三陰性乳癌的第一線治療方案。我們將於 12 月在聖安東尼奧乳腺病大會上展示 TNBC 數據。

  • We've also been working with urgency with our BioNTech partners and made very good progress building a robust clinical development program. In fact, we'll be initiating two new studies that are now posted on clinicaltrials.gov in first-line MSS CRC. And as you know, that's not a place where first-generation PD-1, PD-L1s have shown activity as well as in first-line gastric cancer.

    我們也與 BioNTech 的合作夥伴密切合作,在建立穩健的臨床開發專案方面取得了非常好的進展。事實上,我們將啟動兩項新的研究,目前已在 clinicaltrials.gov 上發布,研究對象為第一線 MSS CRC 患者。如您所知,第一代 PD-1、PD-L1 受體激動劑在胃癌一線治療中並未顯示出相同的活性。

  • So our focus is on speed to market. Our opportunity is to be either first or second to market across indications. And we feel very good about combining our industry-leading commercial and operational capabilities with BioNTech's scientific expertise. And we plan to maximize the potential of this asset.

    因此,我們的重點是加快產品上市速度。我們的機會在於,在所有適應症領域,我們都能成為第一個或第二個進入市場的。我們非常高興能夠將我們行業領先的商業和營運能力與 BioNTech 的科學專長相結合。我們計劃最大限度地發揮這項資產的潛力。

  • Operator

    Operator

  • David Amsellem, Piper Sandler.

    大衛·阿姆塞勒姆,派珀·桑德勒。

  • David Amsellem - Analyst

    David Amsellem - Analyst

  • So I wanted to come back to Cobenfy. And not trying to read too much into the prescription data over the summer relative to earlier this year, but I didn't want to ask about how you're thinking about potential or key barriers to adoption thus far? Is it GI tolerability? Is it twice daily dosing? Is it just prescriber inertia in terms of the dominance of the D2 blockers?

    所以我想回到Cobenfy。我並不想過度解讀今年夏季的處方數據與今年早些時候的數據,但我不想問您如何看待迄今為止推廣應用可能面臨的主要障礙或關鍵障礙?這是胃腸道耐受性問題嗎?是每天服用兩次嗎?D2受體阻斷劑佔據主導地位僅僅是處方醫師的慣性嗎?

  • Just wanted to get a better sense of what you're hearing and seeing in the field and what you think you need to do to drive more acceptance of product among psychiatrists.

    我只是想更了解您在該領域聽到和看到的情況,以及您認為需要做些什麼來提高精神科醫生對該產品接受度。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, David. I'll turn it to Adam. But one thing -- I just was in the field on with Cobenfy sales reps very recently. And what I would say is that once physicians begin to use these products and patients have access to it, one thing that gives us a lot of confidence about the long-term potential of this product in schizophrenia is the feedback that we're getting from both. Feedback continues to be very strong. But I'll let Adam go through the specifics around your question.

    謝謝你的提問,大衛。我把它轉交給亞當。但有一件事——我前不久剛和 Cobenfy 的銷售代表一起外出考察過。我想說的是,一旦醫生開始使用這些產品,患者也能獲得這些產品,我們從醫生和患者雙方得到的回饋讓我們對該產品在治療精神分裂症方面的長期潛力充滿信心。反饋依然非常強烈。但我會讓亞當來詳細解答你的問題。

  • Adam Lenkowsky - Chief Commercialization Officer

    Adam Lenkowsky - Chief Commercialization Officer

  • Yeah, David, I appreciate the question. So as I said earlier, we're pleased with the progress that we've made. We're now just about a little over one year in the market right now. And this is an entrenched market. This is the first new mechanism that's been approved in over three decades in the space.

    是的,大衛,感謝你的提問。正如我之前所說,我們對所取得的進展感到滿意。我們進入市場至今已經一年多了。這是一個根深蒂固的市場。這是該領域三十多年來首個獲得批准的新機制。

  • And so I think what's really important, what we look for in terms of leading indicators are adding new trialists. And we're tracking very well on a weekly basis as well as new prescriptions. When we look at the feedback in general, the feedback is very positive regarding Cobenfy's profile, as Chris mentioned.

    所以我認為真正重要的,我們尋找的領先指標是增加新的試驗參與者。我們每週的追蹤數據以及新處方數量都非常好。總的來說,正如克里斯提到的那樣,大家對 Cobenfy 的個人資料的反饋非常積極。

  • I would say that the number one question that we get as a team is around how to switch from a D2 to Cobenfy. And even from physicians who are sitting on the sidelines, that's the question they want to know. And so we've got robust peer-to-peer activities that are ongoing. We've introduced real-world data, and we have a Phase IV switch study that reads out early next year. All will help build physician confidence.

    我想說,我們團隊收到的最多的問題是如何從 D2 切換到 Cobenfy。即使是那些袖手旁觀的醫生,也想知道這個問題。因此,我們擁有持續進行的、強大的點對點活動。我們已經引入了真實世界的數據,並且我們正在進行一項 IV 期轉換研究,該研究將於明年初公佈結果。所有這些都有助於增強醫生的信心。

  • What I'll say is if you look historically all the recently launched D2s, we are tracking ahead of all recently launched analogs in schizophrenia. So based on everything that we're seeing, we feel good about the performance for Cobenfy. We're going to continue to see steady growth and the inflection will come as we continue to add new indications.

    我想說的是,如果你回顧最近推出的所有D2藥物的歷史數據,你會發現我們在治療精神分裂症方面領先於所有最近推出的類似藥物。綜上所述,我們對 Cobenfy 的表現感到滿意。我們將繼續看到穩定成長,隨著我們不斷增加新的適應症,轉折點將會出現。

  • Operator

    Operator

  • Asad Haider, Goldman Sachs.

    阿薩德·海德爾,高盛集團。

  • Asad Haider - Analyst

    Asad Haider - Analyst

  • Congrats on the quarter. Just first for Chris or David, on the cost side, as it relates to your strategic productivity initiatives where another $1 billion in cost savings is expected to drop to the bottom line by 2027, any updated thoughts on the shape of this over the next couple of years in the context of the potential R&D expenses associated with the development of BNT-327 as it starts to go forward into later-stage Phase III programs, recognizing, of course, that you have other Phase III programs over the next 18 to 24 months are going to come off? Just trying to understand the margin trajectory as we go through these pushes and pulls.

    恭喜你本季取得佳績。首先,Chris 或 David,關於成本方面,鑑於你們的戰略生產力計劃預計到 2027 年將節省 10 億美元的成本,你們對未來幾年該計劃的進展情況有什麼最新的想法嗎?考慮到 BNT-327 研發進入後期 III 期計畫後可能產生的研發費用,當然,你們也意識到未來 18 到 24 個月內還有其他 III 期計畫即將啟動?我只是想了解在這些拉鋸戰中利潤率的走勢。

  • And then second for Cristian. Maybe just double clicking on your previous response. Could you share with us any early thoughts on the pipeline and if there are programs that you're particularly encouraged by? Thank you.

    其次是克里斯蒂安。或許只要雙擊你先前的回覆即可。您能否與我們分享您對人才培育計畫的初步想法,以及您特別看好的項目?謝謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Maybe I'll start and turn it to David for the first question, and then Cristian, you can pick up the second question. Just on the cost side, as David goes through some of the specifics, the one thing I would just remind everyone is that the way we think about costs and our investment profile generally is there's a balance that's going to be maintained. One is continuing to invest in areas to drive value and growth. That's not only on the pipeline, including B&T but the R&D organization more generally.

    也許我可以先開始,讓大衛回答第一個問題,然後克里斯蒂安,你可以回答第二個問題。就成本方面而言,正如 David 詳細介紹的一些細節,我只想提醒大家,我們對成本和投資狀況的考慮方式是,要保持一種平衡。一家公司正持續投資於能夠推動價值和成長的領域。這不僅包括 B&T,而且是整個研發機構都在考慮的。

  • And then, of course, as we did this past few quarters, investing in the growth profile of the company with Adam's organization. At the same time, we have committed, and I think you've seen it in the numbers over the last number of quarters, is we're going to be disciplined with respect to financial management. And that's going to be our operating approach going forward. David?

    當然,就像過去幾個季度我們所做的那樣,我們與亞當的團隊一起投資於公司的成長前景。同時,我們已經承諾,而且我認為你們已經從過去幾季的數字中看到了這一點,那就是我們將嚴格遵守財務管理規定。這將是我們今後的運作方式。大衛?

  • David Elkins - Executive Vice President, Chief Financial Officer, Member of the Leadership Team

    David Elkins - Executive Vice President, Chief Financial Officer, Member of the Leadership Team

  • Yeah. Asad, I know '26 is top of mind for many folks. And so let me just share with you how I'm thinking about it overall. First, we're exiting 2025 with really strong performance from our Growth Portfolio. Year to date, it's up 16%. And as I said in the prepared remarks, we now have four products that are annualizing greater than $1 billion in that Growth Portfolio. So we're exiting this year in really good shape as we head into next year.

    是的。阿薩德,我知道很多人最關心的是26年。所以,讓我跟你們分享我的整體想法。首先,我們的成長型投資組合在 2025 年取得了非常強勁的表現。今年迄今為止,上漲了16%。正如我在準備好的演講稿中所說,我們現在有四款產品,其成長組合的年化收入超過 10 億美元。因此,我們以非常好的狀態結束了今年,並邁入了新的一年。

  • We're also executing well against our efficiency commitments. We're on track for $1 billion this year, and we have clear line of sight to the $2 billion that we're targeting by 2027. So feel good about that as well.

    我們在履行效率承諾方面也表現出色。我們今年預計將實現 10 億美元的目標,並且有清晰的跡象表明,到 2027 年,我們將實現 20 億美元的目標。所以,你也應該為此感到高興。

  • And also remember, we have numerous Phase III programs completing next year and going into 2027. And just as a reference point, our 2024 cost base was $17.8 billion and we're guiding $16.5 billion this year. So we made really good progress. And I'd say, overall, we have a clear line of sight to the pushes and pulls at '26, and I feel confident in our ability to manage the cost base. And as Chris said, what we're doing, we're focused on balancing up investments that we need to do in order to drive growth in the Growth Portfolio as well as to create headroom for additional business development. And we'll balance that with our savings program.

    另外,請記住,我們有許多第三階段項目將於明年完成,並將持續到 2027 年。作為參考,我們 2024 年的成本基數為 178 億美元,而我們今年的成本基數預計為 165 億美元。我們取得了非常好的進展。總的來說,我認為我們對 2026 年的各種利弊都有著清晰的認識,我對我們控製成本的能力充滿信心。正如克里斯所說,我們正在做的,是專注於平衡我們需要進行的投資,以推動成長投資組合的成長,並為進一步的業務發展創造空間。我們將透過儲蓄計劃來平衡這部分支出。

  • And look, we're getting smarter as we go when we see additional opportunities. So we have a lot of P&L flexibility and we're going to remain financially disciplined as we go through this transition period. And this financial discipline not only helps us manage our margins, but it also provides a strong basis to deliver cash flows to strengthen the balance sheet as we committed to, provide both strategic and financial flexibility and continue to build on the Growth Portfolio. Cristian?

    而且你看,隨著經驗的積累,我們會變得越來越聰明,抓住更多機會。因此,我們在損益方面擁有很大的靈活性,並且我們將在這個過渡時期保持財務紀律。這種財務紀律不僅有助於我們管理利潤率,而且還為我們提供了堅實的基礎,使我們能夠實現現金流,從而加強資產負債表,正如我們所承諾的那樣,提供戰略和財務靈活性,並繼續發展增長型投資組合。克里斯蒂安?

  • Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

    Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

  • That's okay. Chuck, I can speak lengthy. Asad, thank you for the question. I mean, I cannot speak about solid tumors and oncology, but there are a lot of exciting readout and asset in the portfolio. I think we talked about Cobenfy and how invested we are on this drug and how excited we are because there are multiple readouts. I want to speak on two short-term potential readouts.

    沒關係。查克,我能說很多話。阿薩德,謝謝你的提問。我的意思是,我無法談論實體瘤和腫瘤學,但我們的產品組合中有很多令人興奮的成果和資產。我想我們討論過 Cobenfy,以及我們對這種藥物的投入程度和興奮之情,因為有多項數據公佈。我想談兩個短期潛在指標。

  • One is milvexian. When I digged into milvexian, I think BMS, first of all, has a deep expertise and understanding of this area, this market, cardiovascular. This is an oral next-generation Factor XIa anticoagulant and can be the first maybe and the only Factor XIa in atrial fibrillation and ACS and potentially best-in-class in SSP. So I'm really eager to see the readout of these studies. ACS and SSP are planned next year, and we are really pleased that we can complete atrial fibrillation study next year.

    一個是米爾維克斯人。當我深入了解 Milvexian 之後,我認為 BMS 首先對心血管領域、這個市場有著深刻的專業知識和理解。這是一種口服的下一代因子XIa抗凝血劑,可能是第一個,也可能是唯一一個用於治療心房顫動和急性冠狀動脈綜合症的因子XIa,並且有可能成為SSP中最好的同類藥物。所以我非常渴望看到這些研究的結果。ACS 和 SSP 計劃在明年進行,我們非常高興明年能夠完成房顫研究。

  • The other drug I want to point out is admilparant because admilparant is playing in a very difficult disease, pulmonary fibrosis. That is a huge medical need, and Chris mentioned that. I think we have very strong proof of concept in both IPF and PPF because the Phase II study that is underneath the registrational programs show more than 60% improvement in lung function decline. I think this is give us a lot of confidence on the two pivotal studies, and very eager to see the FPF1 and the dynamics here.

    我想指出的另一種藥物是阿米帕蘭,因為阿米帕蘭在治療一種非常棘手的疾病——肺纖維化中發揮作用。這是一個巨大的醫療需求,克里斯也提到了這一點。我認為我們在特發性肺纖維化 (IPF) 和原發性肺纖維化 (PPF) 方面都有非常強大的概念驗證,因為註冊項目下的 II 期研究顯示肺功能下降改善超過 60%。我認為這讓我們對這兩項關鍵研究充滿信心,並且非常渴望看到 FPF1 及其動態變化。

  • Now let me talk a little bit about the platform because this is a short term and more on the midterm. I'm really, really excited in what are some of the scientific platform this company can leverage. One is the protein degradation. BMS is a leader in this space, think Revlimid, Pomalyst. And I think today, targeted protein degradation is one of the priority research platforms across the TAs.

    現在讓我簡單談談這個平台,因為這是短期問題,更多的是關於中期問題。我對這家公司可以利用的一些科學平台感到非常興奮。其中之一是蛋白質降解。百時美施貴寶是該領域的領導者,例如瑞復美和泊馬度胺。我認為,如今標靶蛋白質降解是各個標靶治療領域優先研究的平台之一。

  • In our portfolio, if you scrutinize a bit every stage, Phase III, II, and I, we have more than 10 in clinic that are protein degraders. And what excites me most is not that we just have a platform with preliminary data. Now we have Phase III data. Iberdomide met the primary point in relapse refractory myeloma for MRD negativity rate. And of course, we release that. And this is the first readout of why driving this platform give us confidence.

    在我們的產品組合中,如果您仔細查看每個階段(III 期、II 期和 I 期),我們會發現我們有超過 10 種蛋白質降解劑正在進行臨床研究。最令我興奮的不是我們只擁有了一個包含初步數據的平台。現在我們有了第三期臨床試驗數據。伊比度胺在復發難治性多發性骨髓瘤的微小殘留病灶陰性率方面達到了主要目標。當然,我們會發布相關資訊。這是推動該平台發展給我們帶來信心的第一個原因。

  • The other one, basically, I want to mention because I think it's very relevant is the platform that we are putting together in cell therapy for autoimmune diseases. We have an autologous CD19 CAR T. We presented the data in CR a few days ago, a preliminary data, spectacular data across indication, lupus (inaudible) and myositis. And we have also a CD19 allogeneic CAR T in this space that is in clinic. It can represent an of-the-shelf option.

    另外,我想提一下,因為我認為它非常重要,那就是我們正在為自體免疫疾病的細胞療法所建構的平台。我們有一種自體 CD19 CAR T 細胞療法。幾天前我們在 CR 會議上公佈了初步數據,結果顯示,該療法在治療狼瘡(聽不清楚)和肌肉炎等適應症方面取得了顯著療效。我們目前還有一種 CD19 同種異體 CAR T 療法正在進行臨床治療。它可以代表一種現成的選擇。

  • And we acquired Orbital now that give us the in vivo platform that can be transformative in this space for multiple reasons. So this is great if you think, because it's, first of all, a step forward in the concept of immune reset and potentially to cure more patients with the autoimmune diseases, and BMS can only space. This is very exciting here. .

    我們現在收購了 Orbital,它為我們提供了體內平台,這在許多方面都可能改變這一領域。所以,如果你認為這是件好事,那麼首先,這是免疫重置概念向前邁出的一步,有可能治癒更多自體免疫疾病患者,而 BMS 只能在太空中發揮作用。這裡真是太令人興奮了。。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    莫希特·班薩爾,富國銀行。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • My question is regarding the VEGF PD1 and the data we have seen from summit so far. So what is your impression of the data, especially on the OS side of things? And the second part of the question is that, I mean, there are two ways to think about it. One is like you could actually go after indications where PD-1s work really well or you could go after indications where VEGF work well and PD-1 could add some value there. Is there an either/or approach here? Or could there be a scenario where it works better to improve the efficacy of VEGF with the VEGF PD-1 approach? How do you think about that? Thank you.

    我的問題是關於 VEGF PD1 以及我們目前從高峰會看到的數據。那麼您對這些數據有何印象,尤其是在作業系統方面?問題的第二部分是,我的意思是,有兩種思考方式。一種方法是,你可以選擇 PD-1 抑制劑療效顯著的適應症,或選擇 VEGF 抑制劑療效顯著的適應症,而 PD-1 抑制劑可能在其中發揮一些作用。這裡是否有非此即彼的選擇?或者是否有這種情況:採用 VEGF PD-1 方法可以更好地提高 VEGF 的療效?你對此有何看法?謝謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Adam?

    亞當?

  • Adam Lenkowsky - Chief Commercialization Officer

    Adam Lenkowsky - Chief Commercialization Officer

  • Yeah, Mohit, thanks for the question. So in terms of what we have seen, we are encouraged by the magnitude and consistency of the PFS data that we believe will ultimately translate into a survival benefit over time. So the data we've seen adds to our conviction of the broad development plan that we're building. I do think in terms of the strategy that we have employed, as you can see, our strategy really is twofold.

    是的,莫希特,謝謝你的提問。就我們目前所看到的而言,我們對 PFS 數據的規模和一致性感到鼓舞,我們相信這最終會隨著時間的推移轉化為生存而受益。因此,我們看到的數據更加堅定了我們對正在製定的整體發展計劃的信心。我認為,就我們所採用的策略而言,正如你所看到的,我們的策略實際上是雙重的。

  • One is to become the new standard of care. For example, when you look at the studies we have in first-line non-small cell lung cancer versus standard of care as well as in small cell lung cancer, but also a good example of expanding beyond where PD-1, PD-L1s play. And that's in MSS CRC. And so that's the balance that we are taking as it relates to the strategy for pumitamig.

    其一是成為新的護理標準。例如,當你查看我們在非小細胞肺癌一線治療與標準治療以及小細胞肺癌方面的研究時,你會發現,PD-1、PD-L1 的作用範圍已經擴展到其他領域,這是一個很好的例子。那是在 MSS CRC 中。所以,這就是我們在製定普米塔米格策略時所採取的平衡策略。

  • The other exciting factor that we have across both of our companies is the ability to combine pumitamig with novel combinations. So we've got a host of novel combinations, ADCs, targeted treatments, et cetera, that both companies we'll look to employ as quickly as possible. And we very much look forward to sharing these additional studies as they're ready to be posted online in clinicaltrials.gov.

    我們兩家公司擁有的另一個令人興奮的因素是能夠將普米他米與新型組合結合。因此,我們有許多新穎的組合療法、抗體藥物偶聯物、標靶治療等等,我們兩家公司都將盡快採用這些療法。我們非常期待與大家分享這些額外的研究,一旦它們準備好在 clinicaltrials.gov 上發布,我們將立即與大家見面。

  • Operator

    Operator

  • Tim Anderson, Bank of America.

    提姆安德森,美國銀行。

  • Timothy Anderson - Analyst

    Timothy Anderson - Analyst

  • A couple of questions. The first is on trough earnings. Chris, are you still looking at very late 2020s relative to what you've made been forecasting, say, a year ago? Is that trending towards being pulled forward or being pushed back or maybe staying the same? We've seen lots of developments both at Bristol and then industry wide, and I'm wondering if any of that has changed the timing of reaching trough earnings.

    幾個問題。第一點是關於低谷收益。克里斯,你現在對 2020 年代後期的預測是否與你一年前的預測一致?這種趨勢是向前發展、向後發展,還是保持不變?我們看到布里斯托爾以及整個行業都發生了很多變化,我想知道這些變化是否改變了盈利觸底的時間。

  • And then just on Cobenfy, as you undoubtedly know, there's heightened investor nervousness around ADEPT-2 on the back of comments that were made in Q2. Do you think investors read too much into those comments that Samit has made? Thank you.

    而正如您無疑所知,Cobenfy 上,由於第二季度發表的評論,投資者對 ADEPT-2 的擔憂情緒有所加劇。你認為投資人是否對薩米特的那些言論過度解讀了?謝謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • So first of all, Tim, before I answer the questions, I just want to say congratulations on your next move. We're going to miss you on the calls, and we won't take it personally. With respect to trough, as you know and as we've discussed previously, we have not given long-term guidance just as a standard, of course, and that applies, obviously, to how we're thinking about the specifics of the trough.

    提姆,首先,在我回答問題之前,我想祝賀你邁出下一步。我們會想念你在電話裡的身影,我們不會介意的。關於低谷,正如您所知,也正如我們之前討論過的,我們當然不會給出長期指導意見,這只是一個標準,而且顯然,這也適用於我們如何思考低谷的具體情況。

  • What I will say is that there's a consistency in what our focus has been. We continue to be focused on making this trough as shallow and as short as possible. We still anticipate that we're going to be exiting this decade with growth. Our North Star continues to be that we're going to grow as quickly as possible in order to maximize that exit trajectory, and we're doing the things necessary to enable us to do that.

    我想說的是,我們的關注點始終如一。我們將繼續致力於使這個凹槽盡可能淺、盡可能短。我們仍然預計,我們將以成長的勢頭結束這十年。我們始終堅持以最快的速度發展,以最大限度地實現退出目標,我們正在採取一切必要措施來實現這一目標。

  • You see the performance that we delivered on the commercial side, obviously, that provides a very good foundation for how we think about our ability to navigate through the trough and exit with robust growth. Cristian has commented on the strength of our late-stage pipeline. We've got to continue to deliver that. And clearly, it's going to be important that we continue to maintain financial flexibility so that if we find additional substrate that makes sense for us to be the owner of, that we can engage either in partnerships or business development as appropriate. And that's generally how we're continuing to think about the trough.

    顯然,我們在商業方面取得的成績為我們如何看待自己能否渡過低谷並實現強勁成長奠定了非常好的基礎。Cristian 對我們後期研發管線的實力給予了高度評價。我們必須繼續做到這一點。顯然,保持財務靈活性非常重要,這樣,如果我們發現其他適合我們擁有的資產,我們就可以酌情進行合作或業務拓展。這就是我們目前對低谷時期的整體看法。

  • With respect to the comments last quarter and this quarter, look, what I can say is that there's a lot of focus on execution of the company. There's a lot of focus on ensuring that we continue to deliver on that pipeline. We obviously understand there's a lot of focus on individual programs, including the ones that are going to be reading out most near term and that would include the ADEPT programs.

    關於上個季度和本季的評論,我想說的是,公司非常注重執行力。我們非常重視確保繼續推進該專案。我們當然知道大家非常關注各個項目,包括那些近期最有可能公佈結果的項目,其中就包括 ADEPT 項目。

  • So I wouldn't read too much into it other than to say that there's a lot of focus on us being able to deliver on each of the stages of our strategy, commercial execution. I think we feel really good about what we delivered this quarter, the strength of the late-stage pipeline and executing that, and we've talked about that, and then also continuing to deliver strong financials with disciplined cost management. And we've done that, too. So feel good about where we are.

    所以,我不會對此過度解讀,只想說,我們非常注重確保能夠實現策略和商業執行的各個階段。我認為我們對本季度取得的成績感到非常滿意,後期研發管線實力雄厚,執行到位,我們也討論過這一點,同時我們也繼續透過嚴格的成本管理實現了強勁的財務業績。我們也做到了。所以,請對我們目前所處的位置感到滿意。

  • Operator

    Operator

  • Luisa Hector, Berenberg.

    路易莎·赫克托,貝倫貝格。

  • Luisa Hector - Equity Analyst

    Luisa Hector - Equity Analyst

  • Maybe a policy question. I just wondered whether we should be worried about the lack of any subsequent deals with the administration. Is there perhaps a bandwidth issue? Just trying to -- you're in the queue waiting your turn to negotiate.

    或許是個政策問題。我只是想知道,我們是否應該擔心之後與政府方面沒有任何協議。會不會是頻寬問題?只是想試試——你正在排隊等待輪到你談判。

  • And then maybe just sort of expand that a little bit on to potential DTC offerings. You already have Eliquis. Anything you can comment in terms of that going live? Any impact on volumes? And then perhaps just a mention of that guidance that you have for Eliquis for '26 and '27. How confident are you? Can you tighten those ranges at all now that we're sort of through '25, you've seen the Part D restructure impact and the DTC? So some of those changes there, how they're informing your view of Eliquis as we go forward. Thank you.

    然後或許可以稍微擴充一下,看看能否推出面向消費者的直接銷售產品。你已經有艾樂妥了。關於上線這件事,有什麼可以補充的嗎?對銷量有影響嗎?然後或許可以提一下您對 Eliquis 在 2026 年和 2027 年的指導意見。你有多大信心?既然我們已經基本完成了 2025 年的工作,並且已經看到了 Part D 重組的影響以及 DTC 的影響,那麼現在是否可以稍微收緊這些範圍呢?所以,這些變化中的一些,是如何影響你對 Eliquis 的看法的呢?謝謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, Luisa. Maybe I'll start, and then I'll flip it over to Adam. Look, obviously, the policy environment remains very dynamic, both from a US and an ex US perspective, for that matter.

    謝謝你的提問,路易莎。也許我會先開始,然後把機會交給亞當。顯然,無論從美國或美國以外的國家的角度來看,政策環境仍然非常動態。

  • I don't know that I'd read too much into no additional deals over the last week or so. What I would say from a BMS standpoint is we continue to actively engage with the administration. I would characterize those discussions as frequent. And while not always fully aligned, they're always constructive and thought-provoking on both sides. Clearly, tariffs are front and center, but we continue to monitor a host of other issues, including the shutdown and what potential impact that could have downstream. And then there's, of course, a lot going on ex US.

    我不認為過去一周左右沒有達成任何新交易應該過度解讀。從BMS的角度來看,我想說的是,我們將繼續積極與管理階層溝通。我會將這些討論描述為頻繁的。雖然雙方的觀點並非總是完全一致,但他們始終都能提出建設性的意見,並引發思考。顯然,關稅是當前關注的焦點,但我們將繼續關註一系列其他問題,包括政府停擺及其可能對下游產生的潛在影響。當然,美國以外也發生了很多事情。

  • Framing all of that for us, though, is that -- we agree with the President on the need for equalization of prices. US prices need to come down. We're sharing ideas to do that. Ex US prices need to come up. We've seen some good progress, for example, in the UK, but more needs to be done. And accomplishing those objectives while preserving the ecosystem for innovation that we have in the US is what we're focused on.

    不過,歸根究底,我們同意總統對價格均衡化的觀點。美國物價需要下降。我們正在交流想法來實現這一目標。美國出口價格需要上漲。例如,英國已經取得了一些不錯的進展,但仍需做更多的工作。我們關注的重點是在實現這些目標的同時,保護美國現有的創新生態系統。

  • So there's a lot going on. It's manageable. We have a great team in DC of whom I'm incredibly proud, and we're engaging at the right levels. I'll let Adam handle the DTC questions.

    所以現在發生了很多事。這是可以控制的。我們在華盛頓特區擁有一支非常優秀的團隊,我為他們感到無比自豪,而且我們的參與度也恰到好處。DTC方面的問題就交給亞當來解答吧。

  • Adam Lenkowsky - Chief Commercialization Officer

    Adam Lenkowsky - Chief Commercialization Officer

  • Yeah, Luisa, thanks. So as far as the direct-to-patient program, as you know, as part of our commitment to increasing patient access, we, with our Pfizer partners for Eliquis, we announced that Eliquis would be available via direct to patient at a discounted rate, over 40% less than the list price. I can say since launching the program, we have received a substantial number of inquiries through Eliquis 360.

    是啊,路易莎,謝謝。至於直接面向患者的計劃,正如您所知,作為我們致力於增加患者用藥機會的一部分,我們與輝瑞公司合作推出 Eliquis,並宣布 Eliquis 將以折扣價直接面向患者銷售,比標價低 40% 以上。我可以肯定地說,自從推出該計劃以來,我們已經透過 Eliquis 360 收到了大量的諮詢。

  • If you remember, we also subsequently announced the Sotyktu will be available via our own direct-to-patient platform at a greater than 80% discount effective January 1. So we're launching this as part of our commitment to patient access and affordability. As Chris mentioned, we're listening, we're coming forward with solutions, and we're doing that with urgency.

    如果您還記得,我們​​隨後也宣布,Sotyktu 將於 1 月 1 日起透過我們自己的直接面向患者的平台以超過 80% 的折扣出售。因此,我們推出這項服務,是為了履行我們對病人獲得醫療服務及負擔能力的承諾。正如克里斯所說,我們正在傾聽,我們正在提出解決方案,而且我們正在以緊迫的態度這樣做。

  • As it relates to Part D redesign, for Eliquis, we are seeing a more even distribution of sales like we talked about throughout this year. We expect to see similar in the Q4 time frame as the coverage gap has been removed. And that is being offset by patients in the catastrophic phase for products like Revlimid, Pomalyst, and Camzyos, for example. So when you look on a net basis, we're roughly equal in terms of the positives and the negatives.

    關於D部分重新設計,就艾樂妥而言,我們看到銷售分佈更加均勻,就像我們今年一直在討論的那樣。我們預計在第四季度也會出現類似的情況,因為覆蓋缺口已被消除。例如,瑞復美、泊馬度胺和卡美洛等產品在災難性階段的患者數量正在抵消這種影響。所以從整體來看,我們在正面因素和負面因素方面大致相當。

  • Operator

    Operator

  • David Risinger, Leerink Partners.

    David Risinger,Leerink Partners。

  • David Risinger - Analyst

    David Risinger - Analyst

  • Yeah. Congrats on the strong third-quarter results. So I have two questions, please. First, milvexian is being dosed at 25 milligrams BID in secondary stroke prevention, which is the same daily dose as Bayer's Asundexian 50 milligrams QD. So could you please discuss milvexian's profile, including its potency relative to Asundexian and comment on Asundexian's secondary stroke prevention Phase III trial readout in coming months and implications for milvexian's secondary stroke prevention readout in the second half of '26?

    是的。恭喜該公司第三季業績取得強勁成長。所以,我有兩個問題。首先,在二級中風預防中,milvexian 的劑量為 25 毫克,每日兩次,這與拜耳的 Asundexian 的每日劑量 50 毫克,每日一次相同。那麼,您能否討論一下 milvexian 的概況,包括它相對於 Asundexian 的效力,並評論 Asundexian 在未來幾個月內進行的二級中風預防 III 期試驗結果,以及這對 milvexian 在 2026 年下半年進行的二級中風預防試驗結果的影響?

  • And then my separate question is, are IRA prices for the first 10 price-controlled drugs in 2026, including Eliquis, currently being renegotiated? Thank you.

    那麼,我的另一個問題是,2026 年首批 10 種受價格管制藥物(包括 Eliquis)的 IRA 價格目前是否正在重新談判?謝謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • So I will ask Cristian to start and then, Adam, you can briefly comment on the second question.

    那麼,我先請克里斯蒂安開始,然後亞當,你可以簡單地對第二個問題發表一下看法。

  • Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

    Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

  • So let me start with your first part of the question relating to the dose. We believe that we characterized very well the dose, not only the scheduling, the dose, and the design of the trial that we are running. Specifically on your question on the dosing, don't forget that we have a BID administration. And BID administration can actually ensure a better coverage of exposure that you need to get what you want to get. So this, we believe, is an important differentiation so vis-a-vis what maybe other competitive drug can be using. So we are very confident. This is a work that has been scrutinized very carefully in BMS and, of course, with our partner, J&J, in this setting.

    那麼,讓我先回答你關於劑量問題的第一部分。我們相信,我們不僅很好地描述了劑量,還很好地描述了劑量、給藥方案以及我們正在進行的試驗的設計。關於您提出的劑量問題,請記住我們採用的是每日兩次給藥方案。而 BID 管理實際上可以確保更好地覆蓋您所需的曝光範圍,從而實現您的目標。因此,我們認為,這是與其他競爭藥物可能使用的方法的重要區別。所以我們非常有信心。這項工作在百時美施貴寶公司內部以及當然還有我們的合作夥伴強生公司都經過了非常仔細的審查。

  • Let me tell about your second part of the question. I don't want to speculate on future competitive program results. But of all, a positive competitive SSP trial can be great for patients and validates the Factor XIa mechanism in this space. I am confident that our Phase III program that has been developed, as I say, with scrutiny, can maximize the efficacy milvexian and potentially can provide even a superior profile in SSP.

    讓我來回答你問題的第二部分。我不想對未來競賽項目的結果進行猜測。但最重要的是,積極的競爭性 SSP 試驗對患者來說是件好事,並且驗證了該領域中的因子 XIa 機制。我相信,正如我所說,經過仔細審查而開發的 III 期專案可以最大限度地提高 milvexian 的療效,並且有可能在 SSP 中提供更優異的療效。

  • And don't forget that the NAF and the ACS and milvexian is the potentially only Factor XI that can play in this indication. And these are, of course, very important part of the market.

    別忘了,NAF、ACS 和 milvexian 可能是唯一能參與此指標的因子 XI。當然,這些都是市場中非常重要的組成部分。

  • Adam Lenkowsky - Chief Commercialization Officer

    Adam Lenkowsky - Chief Commercialization Officer

  • I'll just add one thing. Cristian, thanks for the answer. We were able to, if you've seen clinicaltrials.gov, accelerate now the readout of atrial fibrillation for milvexian, which is the largest opportunity for the product. So now we expect all three studies to read out in 2026.

    我再補充一點。克里斯蒂安,謝謝你的回答。如果你看過 clinicaltrials.gov,你就會知道我們已經能夠加快 milvexian 治療心房顫動的試驗結果公佈,這是該產品最大的應用前景。因此,我們現在預計這三項研究的結果將在 2026 年公佈。

  • As far as IRA, no, there was no plan to revisit Eliquis negotiation and that price will be effectuated January 1.

    至於 IRA,沒有計劃重新討論 Eliquis 的談判,該價格將於 1 月 1 日生效。

  • Operator

    Operator

  • Carter Gould, Cantor.

    卡特·古爾德,坎托爾。

  • Carter Gould - Analyst

    Carter Gould - Analyst

  • I ask this question with an appreciation that your timelines have been consistent, but there's been lots of discussions around potential scenarios where you might add patients to sites that -- I'm talking about ADEPT-2, you might add patients to sites that underenrolled based. And can you address those discussions and say definitively whether you've gone back and added more patients since enrollment was completed based on your own ct.gov entries? And could that address the variance between what was implied by those time lines and the actual timelines to data? Thank you.

    我提出這個問題,是因為我讚賞你們的時間安排一直都很一致,但是關於一些可能的情況,比如你們可能會在招募人數不足的地點增加患者,已經有很多討論——我指的是 ADEPT-2,你們可能會在招募人數不足的地點增加患者。您能否就這些討論作出回應,並根據您自己的 ct.gov 條目明確說明,自註冊完成以來,您是否又增加了更多患者?這能否解釋這些時間軸所暗示的內容與實際資料時間軸之間的差異?謝謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, Carter. And again, I appreciate there's a lot of interest in the study. All I can say is that we continue to expect the results by the end of the year. We're obviously going to communicate those results when they're available. And the good news is that it's practically November, so we don't have to wait long for the turning of that card.

    謝謝你的提問,卡特。再次感謝大家對這項研究的濃厚興趣。我只能說,我們仍然期待在年底前得到結果。我們當然會在結果出來後公佈這些結果。好消息是,現在已經是十一月了,所以我們不用等太久就能看到這一刻的到來。

  • Operator

    Operator

  • Terence Flynn, Morgan Stanley.

    Terence Flynn,摩根士丹利。

  • Terence Flynn - Analyst

    Terence Flynn - Analyst

  • Maybe just another policy one. We've seen some headlines around these GLOBE and GUARD, what I assume are CMMI pilots for Medicare. Can you weigh in at all in terms of those, if there's any progress or give any details in terms of how those might play out?

    或許只是另一項政策而已。我們已經看到一些關於 GLOBE 和 GUARD 的新聞報道,我猜它們是 Medicare 的 CMMI 試點計畫。您能否就這些方面發表一些看法,例如是否有任何進展,或能否提供一些細節,說明這些進展可能會如何發展?

  • And then a second question is just on iberdomide and your upcoming discussions with the FDA on a potential for a filing on MRD. What's your confidence level that FDA will actually move in that direction? Or do you think they're going to want to see more definitive data first before acting on MRD?

    第二個問題是關於伊貝多米特以及您即將與 FDA 討論的關於 MRD 申報的可能性。你對FDA最終會朝這個方向採取行動有多大信心?或者你認為他們會在對 MRD 採取行動之前,先看到更確鑿的數據嗎?

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • I'll hit the first one, and then I'll ask Cristian to take the second. So on the CMMI potential demos, look, we've obviously seen the same coverage you've seen. I think it's too early to say really anything about what's in them, when they might read out and what the implications of that are. We're obviously actively monitoring and engaging, but nothing new to report there at the moment. And then Cristian, do you want to take the second piece of that on iber.

    我先打第一個,然後讓克里斯蒂安打第二個。所以,關於 CMMI 的潛在演示,你看,我們顯然看到了和你們看到的相同的報導。我認為現在談論這些文件的內容、它們何時發布以及其意義還為時過早。我們當然會積極關注並參與其中,但目前還沒有什麼新的進展可以報告。克里斯蒂安,你想在 iber 上拿第二塊嗎?

  • Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

    Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

  • Yeah. Iber showed this positive outcome in MRD negativity rate. We announced it. We are very pleased that the FDA keeps this very in consideration. There was a lot of discussion.

    是的。Iber 在 MRD 陰性率方面顯示了這一積極結果。我們已經宣布了。我們非常高興FDA對此給予了高度重視。大家進行了很多討論。

  • It is an end point that, of course, we discussed and we agreed with the agency. We will share the data, and we will discuss not only with FDA but with multiple regulatory agencies to see if this readout can grant or not an accelerated conditional approval. And we will keep you posted on the next steps.

    當然,這是我們與該機構討論並達成一致的最終結果。我們將分享這些數據,並將與美國食品藥物管理局(FDA)以及多個監管機構進行討論,以確定該結果是否可以授予加速有條件批准。我們會及時向您通報後續步驟。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    Courtney Breen,Bernstein。

  • Courtney Breen - Equity Analyst

    Courtney Breen - Equity Analyst

  • Just one for me, particularly as we think about the PD-1 VEGF opportunity and the clinical development plan that you've alluded to here. What learnings are you taking from your first round in the PD-1 battle, the development and commercial kind of competition with Merck? What would you have done differently in that? And how are you using kind of a look back at that strategy to improve your approach in arguably a more complex and competitive environment?

    對我來說,只有一個問題,尤其是當我們考慮 PD-1 VEGF 的機會以及您在這裡提到的臨床開發計劃時。在與默克公司進行的PD-1藥物研發和商業競爭的第一輪較量中,你學到了什麼?當時你會採取什麼不同的做法?那麼,在當前更複雜和競爭激烈的環境中,您是如何利用回顧以往策略來改進自身方法的呢?

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, Courtney. And I'll turn it over to Adam, but what I would just highlight is the first learning you can get is with the deal itself. The reality is based on the experience that we've seen in the first round of PD-1, PD-L1 competition, one of the things that's most clear is that the first and second players in that particular race have garnered the vast majority of the commercial value and the ability to help the most patients.

    謝謝你的提問,考特尼。接下來我將把發言權交給亞當,但我只想強調一點,你能學到的第一件事就是交易本身。根據我們在第一輪 PD-1、PD-L1 競爭中看到的經驗,現實情況是,這場競爭中的第一名和第二名已經獲得了絕大部分的商業價值,並且有能力幫助最多的患者。

  • And so our focus coming into this was that we wanted to make sure that if we were going to enter what could be a much more competitive space, that we were in a pull position. And so I think that's what we were able to do with the BioNTech deal. But Adam, do you want to provide specifics?

    因此,我們進入這個領域的重點是,如果我們要進入一個競爭可能更加激烈的領域,我們就要確保自己處於有利地位。所以我覺得這就是我們透過收購 BioNTech 所取得的成就。但是亞當,你想提供一些具體細節嗎?

  • Adam Lenkowsky - Chief Commercialization Officer

    Adam Lenkowsky - Chief Commercialization Officer

  • Yeah, Courtney, thanks for the question. Just a reminder, we're the only company to launch 3 I/O assets with Yervoy, Opdivo, and Opdualag. So we understand what it takes to compete and win in a highly competitive market. We've got the infrastructure in place. We can leverage the capabilities that we built over the years.

    是的,考特尼,謝謝你的提問。再次提醒大家,我們是唯一同時推出 Yervoy、Opdivo 和 Opdualag 這三款 I/O 資產的公司。因此,我們了解在競爭激烈的市場中競爭和獲勝需要哪些條件。基礎設施已經到位。我們可以利用多年來累積的能力。

  • As Chris mentioned, order of entry clearly matters. We've seen that with PD-1, PD-L1s today. I would also say the importance of community oncologist is critically important. They are responsible for about 70% of the prescribing here in the United States and we've got decades-long relationships there.

    正如克里斯所說,入場順序顯然很重要。我們現在在 PD-1 和 PD-L1 中已經看到了這一點。我還想說,社區腫瘤科醫師的重要性至關重要。他們負責美國約 70% 的處方量,我們與他們有著長達數十年的合作關係。

  • Finally, I think the ability and agility to pivot quickly to support new implications is critical. So we've seen this velocity of launches in this first generation of IO with Opdivo now over 30 indications. And the final thing I'd mention in terms of learnings, I do think it's critically important to look at more novel, novel indications. We have seen over the last decade since Opdivo was introduced a host of new mechanisms and modalities that have been introduced to the marketplace that will continue to raise the bar on overall survival.

    最後,我認為能夠迅速調整方向以應對新的變化至關重要。因此,我們已經看到第一代 IO 藥物的上市速度如此之快,Opdivo 目前已有超過 30 種適應症。最後我想提一點,關於經驗教訓,我認為研究更多新穎的指標至關重要。自 Opdivo 推出以來的過去十年裡,我們看到市場上出現了許多新的機制和方法,這些機制和方法將繼續提高整體存活率的標準。

  • So taken together, we're excited about the opportunity we have with pumitamig and our partnership with BioNTech. And our focus is to transform the current standard of care.

    綜上所述,我們對 pumitamig 帶來的機會以及與 BioNTech 的合作感到興奮。我們的目標是改變目前的醫療照護標準。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    阿卡什‧特瓦里,傑富瑞集團。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • Just on ADEPT-2. I think your team has hinted there are no cytorregularities that you're seeing right now and dropouts seem to be similar to the schizophrenia studies. So if that's the case, why hasn't the data been locked at this point? And why open more ex US sites? And can you also comment specifically on what you learned from the open-label period in your relapse prevention studies with Cobenfy in Alzheimer's psychosis? Thanks so much.

    僅在 ADEPT-2 上。我認為你們的團隊已經暗示,目前你們沒有發現任何細胞異常,而且退出研究的情況似乎與精神分裂症研究類似。如果真是這樣,為什麼到現在數據還沒有鎖定?為什麼要開設更多美國以外的站點?您能否具體談談您在使用 Cobenfy 治療阿茲海默症精神病復發預防研究中,從開放標籤期學到了什麼?非常感謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Yeah. Again, I'm just going to reiterate what we said previously. The study is going to be reading out in the next couple of months and we're very close to that. So we're not going to provide additional comments on the specifics. I would also to step back though and remind you of what I said earlier, which is the confidence that we have in the overall Cobenfy program, which is what Cristian spoke to.

    是的。我再次重申我們之前說過的話。這項研究結果將在未來幾個月內公佈,我們距離公佈結果已經非常接近了。因此,我們不會就具體細節提供更多評論。不過,我也想回顧一下我之前說過的話,那就是我們對整個 Cobenfy 計畫的信心,這也是 Cristian 所談到的。

  • And then with respect to why we have so much confidence in the Alzheimer's disease psychosis program, I would just remind you of three things. First, we have compelling external data coming forward from previous studies. We have heard considerable feedback, albeit in the schizophrenia indication on the performance of the product on psychosis symptoms, which again gives us a lot of confidence albeit in a separate setting. And then, of course, we have additional data that we have internally. And so we feel good about where we are with the program at large.

    至於為什麼我們對阿茲海默症精神病治療計畫如此有信心,我只想提醒大家三件事。首先,我們有來自先前研究的令人信服的外部數據。我們已經收到了相當多的回饋,儘管這些回饋是關於該產品在治療精神分裂症症狀方面的表現,但這再次給了我們很大的信心,儘管這是在一個不同的環境中。當然,我們內部還有一些額外的數據。因此,我們對整個專案的進展感到滿意。

  • And obviously, we'll wait to see the ADEPT-2 data between now and the end of the year. And we'll report that out when we get it. Cristian, anything you would add?

    顯然,我們將等待 ADEPT-2 的數據在年底前公佈。我們收到結果後會立即報告。克里斯蒂安,你還有什麼要補充的嗎?

  • Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

    Cristian Massacesi - Chief Medical Officer, Head of Global Drug Development

  • Yeah. I mean, for ADEPT-1, as I said before, this is a relapse prevention design. So it's a different endpoint -- primary endpoint compared to 2 and 4. And of course, the study is ongoing. And we don't want to share data on the leading phase.

    是的。我的意思是,對於 ADEPT-1,正如我之前所說,這是一個預防復發的設計。所以這是一個不同的終點——與 2 和 4 相比,這是主要終點。當然,這項研究仍在進行中。我們不想分享領先階段的數據。

  • This is -- we are putting the patient on Cobenfy for 12 weeks, and then we will assess the response with the same criteria for psychosis. And based on that, the patient will be randomized. Of course, the patient is assessed certain degree of response to be randomized. This is important because, of course, it's a learning -- that part of the study is open label, but of course, we will share the data in a moment which we will release the data.

    也就是說,我們將讓患者服用 Cobenfy 12 週,然後我們將按照精神病的相同標準評估其反應。根據這一結果,患者將被隨機分組。當然,患者需要經過一定程度的療效評估才能進行隨機分組。這很重要,因為這當然是一個學習過程——該研究的這一部分是開放標籤的,但我們當然會在某個時候公佈數據。

  • Chuck Triano - Investor Relations

    Chuck Triano - Investor Relations

  • Operator, if we can take our last question, and then I'll ask Chris to make some closing comments.

    接線員,我們可以回答最後一個問題了,然後我請克里斯做些總結發言。

  • Operator

    Operator

  • Stephen Scala, TD Cowen.

    Stephen Scala,TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • I'm curious if you have concluded the IRA negotiations for Pomalyst and how did the results compare to expectations. GSK indicated yesterday that its negotiations concluded for one of its drugs, and they did not sound troubled in the least at the result of those negotiations. And I'll leave it to one question, given that time is short. So thank you so much.

    我很想知道您是否已經完成了 Pomalyst 的 IRA 談判,結果與預期相比如何。葛蘭素史克昨天表示,某項藥物的談判已經結束,他們對談判結果絲毫沒有感到不安。鑑於時間有限,我只留下一個問題。非常感謝。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks, Steve. Adam, why don't you take that?

    謝謝你,史蒂夫。亞當,為什麼不拿走?

  • Adam Lenkowsky - Chief Commercialization Officer

    Adam Lenkowsky - Chief Commercialization Officer

  • Steve, thanks for the question. Appreciate it. The IRA negotiations officially conclude tomorrow. And so we are currently finalizing that. There's not much I can say about the negotiation except for the fact that, as you know, the negotiation is for Pomalyst.

    史蒂夫,謝謝你的提問。謝謝。愛爾蘭共和軍談判將於明天正式結束。因此,我們目前正在敲定此事。關於談判,我沒什麼好說的,除了你知道,談判是為了 Pomalyst 之外。

  • And so Pomalyst, by the time the MSP is effectuated in January 27, Pomalyst will have lost exclusivity in the US. So again, we don't feel like this will have any impact on the company and the outlook of the company. And we believe that the price will be made public at the latest November 30. What we saw last year that it should come earlier. But taken together, we feel good about the negotiation and where we'll be at the end.

    因此,到 1 月 27 日 MSP 生效時,Pomalyst 將失去在美國的獨家經營權。所以,我們再次強調,我們認為這不會對公司及其前景產生任何影響。我們相信,最晚在11月30日公佈價格。我們去年就看到,它應該會更早到來。但總的來說,我們對談判結果以及最終結果感到滿意。

  • Christopher Boerner - Chairman of the Board, Chief Executive Officer

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks, Adam. And thanks, Chuck, also for choreographing today's call. We know it's a busy morning for all of you, given that there are several companies in our sector that are going to be reporting. So I want to thank you all for joining the call this morning.

    謝謝你,亞當。也要感謝查克,感謝你安排了今天的通話。我們知道今天早上大家都很忙,因為我們這個行業有好幾家公司都要發布財報。所以,我要感謝各位今天早上參加電話會議。

  • In closing, our year-to-date results, I think, reflect the focus that we have on execution with strong performance from the Growth Portfolio, our business development activities that we spoke about during the call, continued progress on our strategic productivity initiatives, and solid free cash flow generation. We're doing what we said we would do. We look forward to the clinical data readouts accelerating into 2026, which, as discussed, have the potential to, we believe, shape the potential of our pipeline and provide more certainty on the shape of our growth trajectory.

    最後,我認為,我們今年迄今為止的業績反映了我們對執行的重視,增長型投資組合表現強勁,我們在電話會議中談到了業務發展活動,我們在戰略生產力計劃方面持續取得進展,以及穩健的自由現金流產生。我們正在履行我們承諾要做的事情。我們期待臨床數據在 2026 年加速公佈,正如先前討論的,我們相信這些數據有可能塑造我們產品線的潛力,並為我們的成長軌跡提供更大的確定性。

  • So again, thank you all for calling in today. And as always, the team is available for any follow-ups. So have a great rest of the day.

    再次感謝大家今天來電。和以往一樣,團隊隨時準備好解答任何後續問題。祝您今天餘下的時間過得愉快。

  • Operator

    Operator

  • The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

    會議已經結束。感謝各位參加今天的報告會。您現在可以斷開連線了。