施貴寶 (BMY) 2025 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good day, and welcome to the Bristol-Myers Squibb second-quarter 2025 earnings conference call. (Operator Instructions) Please note this event is being recorded.

    大家好,歡迎參加百時美施貴寶 2025 年第二季財報電話會議。(操作員指示)請注意,此事件正在被記錄。

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

    現在,我想將會議交給資深副總裁兼投資者關係主管查克·特里亞諾先生。先生,請繼續。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Thank you, and good morning, everyone. We appreciate you joining our second-quarter 2025 earnings call.

    謝謝大家,早安。感謝您參加我們的 2025 年第二季財報電話會議。

  • Joining 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 are Adam Lenkowsky, our Chief Commercialization Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. 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.

    今天早上與我一起發表準備好的發言的還有我們的董事會主席兼首席執行官克里斯·伯納 (Chris Boerner) 和我們的首席財務官戴維·埃爾金斯 (David Elkins)。參加今天電話會議的還有我們的首席商業化官 Adam Lenkowsky;以及我們的首席醫療官兼全球藥物開發主管 Samit Hirawat。今天早些時候,我們將季度幻燈片演示發佈到了 bms.com,您可以透過它來關注 Chris 和 David 的演講。

  • 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.

    在我們開始之前,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做出構成前瞻性陳述的陳述。由於各種重要因素(包括公司提交給美國證券交易委員會的文件中討論的因素),實際結果可能與這些前瞻性陳述所示的結果有重大差異。這些前瞻性陳述代表我們截至今天的估計,不應被視為代表我們截至未來任何日期的估計,並且我們明確表示不承擔更新前瞻性陳述的任何義務,即使我們的估計發生變化。

  • 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.

    我們還將重點關注非公認會計準則財務指標的評論,這些指標經過調整以排除某些特定項目。某些非 GAAP 財務指標與最具可比性的 GAAP 指標的對帳表可在 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,且銷售成長率將在不包括外匯影響的基礎上進行討論。所有對我們損益表的引用均基於非 GAAP 基礎。

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

    說完這些,我就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 second-quarter earnings call.

    謝謝,查克。歡迎,感謝您參加我們的第二季財報電話會議。

  • In Q2, we continue to make good progress reshaping the company for long-term sustainable growth. I'm pleased with our performance, and our financial results speak to that. Building on the momentum from the first quarter, we saw strong demand across our growth portfolio and continue to optimize our cost structure to match the needs of our business.

    在第二季度,我們繼續在重塑公司以實現長期可持續成長方面取得良好進展。我對我們的表現感到滿意,我們的財務表現也證明了這一點。基於第一季的良好勢頭,我們看到了成長投資組合的強勁需求,並繼續優化成本結構以滿足業務需求。

  • Let's double-click on our quarterly performance on slide 4. Our growth portfolio delivered another strong quarter, with sales increasing 17% year over year, primarily driven by demand across all key brands. David will provide more color on our portfolio's performance in his remarks.

    讓我們雙擊幻燈片 4 上的季度業績。我們的成長型產品組合再創佳績,本季銷售額年增 17%,主要得益於所有主要品牌的需求。大衛將在他的評論中詳細介紹我們投資組合的表現。

  • In addition to strong performance in our growth portfolio, we continue to make regulatory progress across the globe. In Europe, we secured approval for both OPDIVO in neoadjuvant lung cancer and for Qvantig across multiple solid tumor indications. Additionally, in the US, we appreciate recent actions by the FDA that have resulted in streamlined patient monitoring requirements and the removal of REMS programs for all cell therapies. This is expected to enable more patients to benefit from these transformative therapies over time.

    除了我們的成長投資組合表現強勁之外,我們還在全球範圍內繼續取得監管進展。在歐洲,我們獲得了 OPDIVO 用於新輔助肺癌治療以及 Qvantig 用於多種實體腫瘤治療的批准。此外,我們讚賞美國 FDA 最近採取的行動,這些行動簡化了患者監測要求並取消了所有細胞療法的 REMS 計劃。預計隨著時間的推移,更多的患者將受益於這些轉化療法。

  • With respect to capital deployment, we announced strategic partnerships with BioNTech to expand and extend our immuno-oncology leadership, as well as with Philochem to strengthen our radiopharmaceutical business and expand our focus in prostate cancer. I will discuss these deals in a moment.

    在資本部署方面,我們宣布與 BioNTech 建立戰略合作夥伴關係,以擴大和延伸我們的免疫腫瘤學領導地位,並與 Philochem 建立戰略合作夥伴關係,以加強我們的放射性藥物業務並擴大我們在前列腺癌方面的重點。我稍後會討論這些交易。

  • With the results achieved in the quarter, we are again raising our top-line guidance, as well as our bottom-line guidance, before considering acquired IP R&D charges in the quarter. Our recent launches of COBENFY and Qvantig are progressing well. COBENFY has delivered strong performance since launch, and we have consistently received positive feedback from physicians. They are seeing firsthand the medicine's differentiated profile with robust efficacy on both positive and negative symptoms and improved cognition.

    根據本季所取得的業績,在考慮本季收購的智慧財產權研發費用之前,我們再次提高了我們的營收預期和淨利預期。我們最近推出的 COBENFY 和 Qvantig 進展順利。COBENFY 自推出以來表現強勁,我們一直收到醫生的正面回饋。他們親眼目睹了這種藥物的差異化特性,它對陽性和陰性症狀均有強大的療效,並能改善認知能力。

  • Regarding the US launch of Qvantig, early feedback is encouraging, with strong uptake. Delivering treatment in just three minutes saves time for patients, caregivers, and providers, while also improving clinic efficiency, increasing patient comfort, and reducing treatment complexity. Additionally, fewer port procedures streamline care, allowing physicians to treat more patients.

    關於 Qvantig 在美國的推出,早期回饋令人鼓舞,採用率很高。只需三分鐘即可完成治療,為患者、照護者和提供者節省時間,同時提高診所效率、增加患者舒適度並降低治療複雜性。此外,更少的端口程序簡化了護理,使醫生能夠治療更多的患者。

  • Now moving to recent business development initiatives on slide 5. First, we entered into a global strategic partnership with BioNTech to co-develop and commercialize BNT327, a potentially transformative PD-L1 VEGF bispecific that could set a new standard of care across multiple tumor types. We're excited to bring together BMS's deep scientific and clinical expertise, development and regulatory capabilities, and commercial infrastructure in the IO space with BioNTech's innovation on BNT327.

    現在轉到投影片 5 上的近期業務發展計畫。首先,我們與 BioNTech 建立了全球策略合作夥伴關係,共同開發和商業化 BNT327,這是一種具有潛在變革性的 PD-L1 VEGF 雙特異性藥物,可以為多種腫瘤類型設定新的治療標準。我們很高興將 BMS 在 IO 領域的深厚科學和臨床專業知識、開發和監管能力以及商業基礎設施與 BioNTech 在 BNT327 上的創新結合起來。

  • With a strong partner, we're well positioned to accelerate existing clinical trials, expedite time to market, and expand the number of indications. The combined capabilities of BMS and BioNTech give us the opportunity to place BNT327 within the first wave of launches in this arena, either first or second to market, a critical advantage in terms of maximizing the commercial opportunity. BNT327 has the potential to become another needle-moving IO therapy and accelerate our overall growth trajectory.

    有了強大的合作夥伴,我們就能加速現有的臨床試驗,加快產品上市時間,並擴大適應症的數量。BMS 和 BioNTech 的綜合實力使我們有機會將 BNT327 置於該領域的第一波發布中,無論是第一個還是第二個進入市場,這對於最大化商業機會而言都是一個關鍵優勢。BNT327 有可能成為另一種針刺式骨內注射療法,並加速我們的整體成長軌跡。

  • The partnership is off to a great start. We are well underway in advancing a robust joint clinical development program that expands upon the initial indications by further developing BNT327 in numerous additional tumor types in combination. We look forward to sharing more information in the future.

    此次合作開局良好。我們正在順利推動一項強有力的聯合臨床開發計劃,該計劃透過進一步開發 BNT327 在多種其他腫瘤類型的組合中,擴大了最初的適應症。我們期待將來分享更多資訊。

  • Separately, in terms of our early-stage pipeline, we entered into a license agreement with Philochem for exclusive worldwide rights to OncoACP3. This is a potential best-in-class radiopharmaceutical therapeutic and diagnostic agent with the opportunity to become a breakthrough treatment for prostate cancer. We believe this collaboration will further strengthen our position in the rapidly advancing radiopharmaceutical space.

    另外,就我們的早期產品線而言,我們與 Philochem 簽訂了許可協議,獲得 OncoACP3 的全球獨家權利。這是一種潛在的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治療方法。我們相信,此次合作將進一步鞏固我們在快速發展的放射性藥物領域的地位。

  • Earlier this week, we announced a transaction with Bain Capital to form a new company focused on advancing innovative immunology therapies. As part of this transaction, we out-licensed five assets to a newly formed company, including three clinical-stage compounds and two Phase 1-ready compounds. This deal represents a compelling opportunity to accelerate the development of these promising immunology assets while also allowing BMS to participate in future value creation through royalties, milestone payments, and a roughly 20% equity stake.

    本週早些時候,我們宣布與貝恩資本達成交易,成立一家專注於推動創新免疫療法的新公司。作為交易的一部分,我們將五項資產授權給一家新成立的公司,其中包括三種臨床階段化合物和兩種準備進入第一階段的化合物。這筆交易代表著一個極具吸引力的機會,可以加速這些有前景的免疫學資產的開發,同時也允許 BMS 透過特許權使用費、里程碑付款和約 20% 的股權參與未來的價值創造。

  • BMS will continue to have a strong presence in immunology. We are focusing our immunology R&D efforts in areas where the company is best positioned to lead. These strategic BD initiatives demonstrate our ability and flexibility to continually identify opportunities to both source external innovation and also externalize pipeline assets where appropriate. This is all in support of our objectives of driving improved growth in the outer years and attractive returns for shareholders.

    BMS 將繼續在免疫學領域佔據重要地位。我們將免疫學研發工作重點放在公司最有領先優勢的領域。這些策略性的 BD 措施展示了我們不斷尋找機會獲取外部創新並在適當的情況下外部化管道資產的能力和靈活性。這一切都是為了支持我們實現未來幾年成長更快、為股東帶來豐厚回報的目標。

  • Moving to our key data catalysts on slide 6. We're entering a data-rich period. In the next 12 to 24 months alone, we expect seven registration assets and seven meaningful life cycle management opportunities. These represent important needle-moving events that can derisk the pipeline and help shape our trajectory through the end of the decade. Recognizing we've had a few studies readout this year where results were not as expected, we are reviewing all of our near-term studies to best ensure the timely delivery of these programs with the highest probability of success.

    前往投影片 6 上的關鍵資料催化劑。我們正進入一個數據豐富的時期。僅在未來 12 到 24 個月內,我們預計會有七項註冊資產和七個有意義的生命週期管理機會。這些都是具有重大意義的事件,可以降低管道風險並幫助我們塑造到本世紀末的發展軌跡。我們認識到今年我們已經有一些研究結果不如預期,我們正在審查我們所有的近期研究,以最大程度地確保及時交付這些項目並取得最高的成功機率。

  • While we are encouraged by the overall breadth of our pipeline, I would highlight three new molecular entities with near-term data readouts. We expect readouts for Milvexian in acute coronary syndrome and secondary stroke prevention next year and for atrial fibrillation in 2027. Data for admilparant in idiopathic pulmonary fibrosis is expected next year. And we're also expecting to see MRD negativity data in-house later this year and PFS data next year from the Phase 3 EXCALIBER study of iberdomide. This could provide additional validation of our CELMoD platform as a next-generation potential standard of care in multiple myeloma.

    雖然我們對我們管道的整體廣度感到鼓舞,但我要強調三種具有近期數據讀數的新分子實體。我們預計明年將公佈 Milvexian 在急性冠狀動脈綜合徵和二級中風預防方面的療效數據,2027 年將公佈其在心房顫動方面的療效數據。預計明年將公佈 Admilparant 治療特發性肺纖維化的數據。我們也預計今年稍後將看到內部的 MRD 陰性數據,明年將看到來自伊貝多胺第 3 階段 EXCALIBER 研究的 PFS 數據。這可以為我們的 CELMoD 平台作為多發性骨髓瘤的下一代潛在治療標準提供額外的驗證。

  • In terms of life cycle management, we now have several ongoing registrational trials for COBENFY in Alzheimer's disease patients. These include studies in Alzheimer's psychosis, agitation, and cognition impairment. In addition, we are also enrolling a Phase 3 study in Bipolar-I disorder. In addition, we have attractive opportunities to invest in numerous oncology pivotal trials. BNT327 is enrolling in first-line non-small cell lung cancer and small cell lung cancer. And a study in first-line triple negative breast cancer is expected to begin later this year.

    在生命週期管理方面,我們目前正在對阿茲海默症患者進行幾項 COBENFY 註冊試驗。其中包括對阿茲海默症精神病、激動和認知障礙的研究。此外,我們也正在進行針對雙極性情感疾患 I 型患者的 3 期研究。此外,我們還有投資眾多腫瘤學關鍵試驗的誘人機會。BNT327正在招募第一線非小細胞肺癌和小細胞肺癌患者。一項針對第一線三陰性乳癌的研究預計將於今年稍後開始。

  • We're also advancing next-generation platforms that could redefine their respective categories. We are initiating two registrational studies for our PRMT5 inhibitor -- one in non-small cell lung cancer and another in pancreatic cancer -- based on encouraging early data with additional longer-term non-small cell lung cancer results to be presented at World Lung. Additionally, we are now recruiting a pivotal study for our EGFR HER3-targeting ADC, Iza-bren, in first-line triple negative breast cancer and expect early data in non-small cell lung cancer and other solid tumors later this year.

    我們也正在推進可以重新定義各自類別的下一代平台。我們正在啟動兩項針對 PRMT5 抑制劑的註冊研究——一項針對非小細胞肺癌,另一項針對胰腺癌——這些研究基於令人鼓舞的早期數據,並將在世界肺臟大會上公佈額外的長期非小細胞肺癌結果。此外,我們目前正在招募針對 EGFR HER3 靶向 ADC Iza-bren 的關鍵研究,用於一線三陰性乳癌,並預計在今年稍後獲得非小細胞肺癌和其他實體腫瘤的早期數據。

  • Lastly, in immunology, we're also now enrolling patients in a pivotal Phase 2 study for our CD19 NEX-T cell therapy in severe refractory lupus. Data readouts are expected to continue next year and throughout the end of the decade, providing an increasing line of sight into the strength of our pipeline. We are investing in and prioritizing areas where we see the strongest potential for high-value assets. We are doing what we said we would do: driving focused execution across the business and delivering solid results as we advance our multi-year plan to emerge as a top-tier sustainable growth company by the end of the decade.

    最後,在免疫學方面,我們現在也正在招募患者參與針對嚴重難治性狼瘡的 CD19 NEX-T 細胞療法的關鍵性 2 期研究。預計數據讀取將於明年以及整個十年末繼續進行,讓我們更清楚地了解我們的管道實力。我們正在投資並優先考慮那些我們認為高價值資產潛力最大的領域。我們正在履行我們曾說過的諾言:推動整個業務的重點執行,並在推進多年計劃的過程中取得堅實的成果,力爭在 2020 年末成為一家頂級的可持續增長公司。

  • Finally, I want to welcome Dr. Cristian Massacesi to BMS, who will be joining us starting tomorrow as Executive Vice President, Chief Medical Officer, and Head of Development. It's a pivotal time to lead our development organization given the number of key pipeline advancements we are making in the months and years ahead. And I look forward to the impact that he will be bringing to our pipeline and the team. I also want to thank Samit for all of his contributions and leadership during his six years at BMS and his commitment to groundbreaking science on behalf of our patients worldwide.

    最後,我要歡迎克里斯蒂安·馬薩塞西博士加入 BMS,他將從明天開始擔任我們的執行副總裁、首席醫療官和開發主管。考慮到未來數月和數年我們將在關鍵管道方面取得的進展數量,現在是領導我們的開發組織的關鍵時刻。我期待他能為我們的管道和團隊帶來影響。我還要感謝薩米特在 BMS 工作六年間所做的所有貢獻和領導,以及他為全球患者做出的開創性科學貢獻。

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

    說完這些,我就把麥克風交給大衛。

  • 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. We continue to deliver strong performance in 2025. Our growth portfolio remains a key focus, and we are executing on driving top-line growth and prioritizing investments to ensure we are positioning the company for long-term sustainable growth.

    謝謝你,克里斯,大家早安。2025年我們將持續保持強勁表現。我們的成長投資組合仍然是我們關注的重點,我們正在努力推動營收成長並優先考慮投資,以確保公司實現長期永續成長。

  • Now turning to the second-quarter sales performance on slide 8. Total company revenues were approximately $12.3 billion, reflecting strong demand across our business. Global sales of the growth portfolio increased approximately 17%, driven primarily by demand for our IO portfolio: Breyanzi, Reblozyl, and CAMZYOS.

    現在就來看看投影片 8 上的第二季銷售業績。公司總收入約為 123 億美元,反映出我們整個業務的強勁需求。成長產品組合的全球銷售額成長了約 17%,主要受我們 IO 產品組合的需求推動:Breyanzi、Reblozyl 和 CAMZYOS。

  • Let's start a review with the oncology portfolio on slide 9. OPDIVO global sales were approximately $2.6 billion, up 7%, driven primarily by demand. In the US, revenues approximately $1.5 billion were largely driven by a strong launch in MSI-high colorectal cancer and continued growth in first-line non-small cell lung cancer. Outside of the US, revenues grew 7%, driven primarily by volume growth and one-time favorable adjustments in the quarter.

    讓我們從第 9 張投影片上的腫瘤學組合開始回顧。OPDIVO 全球銷售額約 26 億美元,成長 7%,主要受需求推動。在美國,約 15 億美元的收入主要得益於 MSI 高結直腸癌的強勁推出以及一線非小細胞肺癌的持續增長。在美國以外,營收成長了 7%,主要得益於本季銷售的成長和一次性有利調整。

  • Turning to Qvantig, we are pleased with the performance in the quarter. Sales were approximately $30 million. The launch in the US is going well with use across all indicated tumor types, received a permanent J-Code on July 1, which will support additional conversion as reimbursement improves. Due to the strong performance year to date, we now expect global OPDIVO sales, together with Qvantig, to deliver stronger growth in the mid to high single-digit range for the full year.

    談到 Qvantig,我們對本季的表現感到滿意。銷售額約 3000 萬美元。該藥物在美國的上市進展順利,適用於所有適應症的腫瘤類型,並於 7 月 1 日獲得了永久的 J 代碼,隨著報銷制度的改善,這將支持進一步的轉換。由於今年迄今的強勁表現,我們現在預計 OPDIVO 與 Qvantig 的全球銷售額將在全年實現中高個位數的強勁增長。

  • Now turning to our hematology performance on slide 10. Reblozyl global sales were $568 million in the quarter and over $1 billion year to date, reflecting continued strength across our MDS-associated anemia indications. In the US, revenue growth was up 30% versus the prior year, primarily due to demand growth in first-line RS-positive and RS-negative MDS-associated anemia. Outside of the US, Reblozyl sales grew 46%, driven by continued demand across newly launched markets.

    現在轉到幻燈片 10 上的血液學表現。Reblozyl 本季全球銷售額為 5.68 億美元,年初至今銷售額超過 10 億美元,反映出我們在 MDS 相關貧血適應症方面的持續強勁表現。在美國,收入成長比前一年增長了 30%,主要原因是對一線 RS 陽性和 RS 陰性 MDS 相關貧血的需求增長。在美國以外,受新興市場持續需求的推動,Reblozyl 的銷售額成長了 46%。

  • Turning to Breyanzi, revenues were $344 million in the quarter. Global revenues grew 122%, reflecting strong demand across all indications and higher-than-expected infusions that benefited the second quarter. We expect strong second half, with sales skewed more towards the fourth quarter as the third quarter normalizes. In the US, sales were $255 million, more than doubling again this quarter, which reflects growth in large B-cell lymphoma, expansion from new indications approved last year, and improved manufacturing success rate. Outside of the US, sales were $88 million, nearly tripling due to strong demand and launches in new markets.

    談到 Breyanzi,本季的營收為 3.44 億美元。全球營收成長了 122%,反映出所有適應症的強勁需求以及高於預期的輸注量,這對第二季有利。我們預計下半年銷售額將表現強勁,隨著第三季銷售額恢復正常,第四季的銷售額將進一步成長。在美國,銷售額為 2.55 億美元,本季再次成長一倍以上,這反映了大 B 細胞淋巴瘤的成長、去年批准的新適應症的擴展以及製造成功率的提高。在美國以外,銷售額達到 8,800 萬美元,由於需求強勁和新市場的推出,成長了近兩倍。

  • Moving to our cardiovascular performance on slide 11. Starting with Camzyos, global sales were $260 million, growing 86% due to robust demand. In the US, sales were $214 million, up 65%, driven primarily by increasing new patient starts. Sequentially, revenues grew 70%, driven by demand as well as a typical second-quarter inventory build. And outside the US, sales were $46 million, reflecting launch momentum in over 20 markets.

    轉到幻燈片 11 上的心血管表現。從 Camzyos 開始,全球銷售額達到 2.6 億美元,由於需求強勁而成長了 86%。在美國,銷售額達到 2.14 億美元,成長 65%,主要得益於新患者的增加。在需求以及第二季度典型的庫存增加的推動下,收入環比增長了 70%。在美國以外,銷售額達到 4,600 萬美元,反映出 20 多個市場的上市動能。

  • Eliquis global sales were $3.7 billion, growing 6% primarily due to strong demand. In-US sales grew 4%, and ex-US sales grew 12%.

    Eliquis 全球銷售額為 37 億美元,成長 6%,主要原因是需求強勁。美國國內銷售額成長 4%,美國境外銷售額成長 12%。

  • Moving to immunology on slide 12. Sotyktu sales grew 29% globally. In the US, sales increased 5%, primarily due to higher demand and an inventory build, which was partially offset by higher rebates associated with increased commercial coverage. We remain focused on driving further demand growth with our improved access position to help offset the impact of higher rebates.

    前往第 12 張投影片上的免疫學部分。Sotyktu 全球銷量成長了 29%。在美國,銷售額成長了 5%,主要原因是需求增加和庫存增加,但商業覆蓋範圍擴大帶來的更高回扣部分抵消了這一增長。我們將繼續致力於透過改善的進入地位來推動進一步的需求成長,以幫助抵消更高回扣的影響。

  • Now moving to discuss COBENFY on slide 13. COBENFY sales were $35 million in the quarter and $62 million year to date. The launch of COBENFY is tracking as we expected. Weekly total prescriptions continue to grow, and we expect continued steady growth, with sales in the second half of the year higher than the first half.

    現在轉到第 13 張投影片討論 COBENFY。COBENFY 本季的銷售額為 3,500 萬美元,年初至今的銷售額為 6,200 萬美元。COBENFY 的推出正如我們所預期的。每週總處方量持續成長,我們預計將繼續穩定成長,下半年的銷售額將高於上半年。

  • Now, let's move to the P&L on slide 14. Gross margin was approximately 73%, primarily due to product mix. As expected, operating expenses were approximately $260 million lower compared to the same period last year, primarily reflecting the results of our ongoing strategic productivity initiative. Our effective tax rate in the quarter was 16.1%, including the impact of the upfront charge for the BioNTech partnership. Overall, diluted earnings per share was $1.46 due to the strong performance in the quarter and includes approximately $1.5 billion, or a $0.57 charge, related to the BioNTech strategic partnership, which is reflected in acquired in-process R&D.

    現在,讓我們轉到第 14 張投影片上的損益表。毛利率約73%,主要由於產品組合。正如預期的那樣,營運費用與去年同期相比減少了約 2.6 億美元,這主要反映了我們正在進行的策略生產力計劃的成果。本季我們的有效稅率為 16.1%,其中包括 BioNTech 合作夥伴關係預付費用的影響。總體而言,由於本季表現強勁,每股攤薄收益為 1.46 美元,其中包括與 BioNTech 戰略合作夥伴關係相關的約 15 億美元(或 0.57 美元)的費用,這反映在收購的在研發中。

  • Turning to the balance sheet and capital allocation highlights on slide 15. Our financial position remains strong, with roughly $13.9 billion in cash, cash equivalents, and marketable securities as of June 30. We generate cash flow from operations of about $3.9 billion in the second quarter.

    前往投影片 15 上的資產負債表和資本配置重點。我們的財務狀況依然強勁,截至 6 月 30 日,現金、現金等價物和有價證券約為 139 億美元。我們第二季的經營現金流約為 39 億美元。

  • Our capital allocation priorities remain unchanged as we continue to take a strategic and balanced approach. Investing in our growth portfolio brands, along with business development, are our top priorities. We're on track with our plan to further delever our balance sheet and pay down $10 billion of debt by the first half of 2026, relative to our March 31, 2024, balance. And we remain committed to returning capital to shareholders through our dividend.

    我們將繼續採取策略性和平衡性的方法,我們的資本配置重點保持不變。投資我們的成長組合品牌以及業務發展是我們的首要任務。我們正在按計劃進一步降低資產負債表的槓桿率,到 2026 年上半年償還 100 億美元的債務(相對於 2024 年 3 月 31 日的餘額)。我們仍然致力於透過股利向股東返還資本。

  • Now, turning to our guidance on slide 16. We're increasing our full-year reported revenue guidance by $700 million at the midpoint to a range of $46.5 billion to $47.5 billion, reflecting continued strong performance of our growth portfolio, better-than-expected legacy sales in the second quarter, and a favorable impact of approximately $200 million related to foreign exchange rates.

    現在,轉到第 16 張投影片上的指示。我們將全年報告營收預期中位數上調 7 億美元,至 465 億美元至 475 億美元之間,這反映了我們成長投資組合的持續強勁表現、第二季度優於預期的舊式銷售以及與外匯匯率相關的約 2 億美元的有利影響。

  • Additionally, we now expect the legacy portfolio to decline approximately 15% to 17% for the year, a more moderate rate than previously anticipated, due primarily to REVLIMID's strong year-to-date performance. We now project full-year REVLIMID sales of approximately $3 billion. We maintain our gross margin guidance at approximately 72%, as some of our high-margin legacy brands are expected to continue to decline through the second half of the year and Eliquis revenues to be more evenly phased throughout the year.

    此外,我們現在預計,今年遺留投資組合的跌幅將達到約 15% 至 17%,這一跌幅比之前預期的要溫和,這主要歸因於 REVLIMID 今年迄今的強勁表現。我們現在預計 REVLIMID 全年銷售額約為 30 億美元。我們將毛利率預期維持在 72% 左右,因為預計我們的一些高利潤傳統品牌將在今年下半年繼續下滑,而 Eliquis 的收入將在全年更加均勻地分佈。

  • We are adjusting our operating expense guidance to increase slightly to approximately $16.5 billion, reflecting investment behind recent business development deals and additional investment opportunities within our growth portfolio. As previously guided, our operating expenses are anticipated to be higher in the second half of the year compared to the first half, reflecting timing of investments, including the recently signed BD deals. Our operating margin target of approximately 37% for the full year remains unchanged.

    我們正在調整我們的營運費用指引,將其小幅增加至約 165 億美元,以反映近期業務發展交易背後的投資以及我們成長投資組合中的額外投資機會。正如先前的指導,我們預計下半年的營運費用將高於上半年,這反映了投資時機,包括最近簽署的 BD 交易。我們全年約 37% 的營業利潤率目標維持不變。

  • For OI&E, we now expect annual income of approximately $250 million due to higher-than-anticipated royalties and favorable interest income, and we're maintaining our full-year tax rate guidance of approximately 18%.

    對於 OI&E,由於特許權使用費高於預期且利息收入良好,我們現在預計年收入約為 2.5 億美元,並且我們維持約 18% 的全年稅率指引。

  • As a result of the strong performance year to date, when excluding acquired in-process R&D charges, the midpoint of our 2025 non-GAAP EPS guidance would have increased approximately $0.20 per share. After including these charges of $0.57 per share, primarily related to the BioNTech partnership, our expected EPS for 2025 is now projected to be between $6.35 and $6.65. This increase reflects the strong performance of our growth portfolio, as well as better-than-anticipated sales from our legacy portfolio, and accommodates recent business development and other growth-oriented investments.

    由於今年迄今的強勁表現,當不包括收購的在研研發費用時,我們 2025 年非 GAAP EPS 指導的中點將增加約 0.20 美元/股。在計入主要與 BioNTech 合作相關的每股 0.57 美元費用後,我們預計 2025 年每股收益將在 6.35 美元至 6.65 美元之間。這一成長反映了我們成長產品組合的強勁表現,以及我們傳統產品組合優於預期的銷售額,並涵蓋了近期的業務發展和其他成長導向投資。

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

    總而言之,我對今年迄今為止的業務表現感到滿意。我要感謝世界各地的同事的持續關注和執行。

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

    接下來,我會把話題轉回給查克,開始問答環節。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Thanks, David. Operator, can we please start the polling for the Q&A session? Thank you.

    謝謝,大衛。接線生,我們可以開始問答環節的投票嗎?謝謝。

  • Operator

    Operator

  • (Operator Instructions) Geoff Meacham, Citibank.

    (操作員指示)花旗銀行的 Geoff Meacham。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • Morning, guys. Thanks for the question. Chris, you mentioned the upcoming period, which is very data-heavy. I'm just looking at the Phase 3 results this year. Are there any that you would call out where maybe you can still achieve the objective of either line extensions or label expansion? I know you probably have to have an FDA discussion, but I just am curious if there maybe is a faster path to achieving some of the line extensions that you intended to achieve. Thanks.

    早安,大家。謝謝你的提問。克里斯,你提到了即將到來的時期,這是一個數據密集的時期。我只是在看今年第三階段的結果。您是否認為仍有可能實現產品線延伸或品牌擴展的目標?我知道您可能需要與 FDA 進行討論,但我只是好奇是否有更快的途徑來實現您想要實現的一些產品線擴展。謝謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, Geoff. Let me just say a few things about the studies that have read out so far, and then maybe I'll turn it over to Samit to answer your question directly.

    謝謝你的提問,傑夫。我先簡單說幾句目前已經讀過的研究,然後我可能會把問題交給薩米特直接回答。

  • First, as we look back at the studies that haven't gone the way we had anticipated, there are two things I think are important to keep in mind. The first is that when you look at those studies in totality, while they were meant to answer important scientific questions or clinical practice questions, they collectively have relatively limited impact on the long-term growth of the company. What is more important is whether or not those studies have any implications going forward, and we don't see any read-forward from those studies to future opportunities. And so we feel good about where we are and the growth potential, as well as the importance of those studies that we'll be reading out over the next 12 to 24 months in order to shape that growth trajectory.

    首先,當我們回顧那些沒有按照我們預期的方式進行的研究時,我認為有兩件事需要牢記。首先,從整體來看,雖然這些研究旨在回答重要的科學問題或臨床實踐問題,但它們對公司的長期成長的影響相對有限。更重要的是這些研究是否對未來有任何影響,而且我們看不到這些研究對未來機會有任何指導意義。因此,我們對目前的狀況和成長潛力感到滿意,同時也對未來 12 到 24 個月內我們將要閱讀的那些研究的重要性感到滿意,這些研究對於塑造成長軌跡至關重要。

  • But Samit, maybe you can comment on the studies that have read out this year.

    但是薩米特,也許你可以對今年讀出的研究發表評論。

  • Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

    Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

  • Yeah. Thank you, Chris, and thank you, Geoff.

    是的。謝謝你,克里斯,謝謝你,傑夫。

  • I think one of the examples of how we think about deeper review of the data would be, let's say, independence trials for Reblozyl, for example. As we've communicated, we look deep into the data, and there is clinically meaningful impact that we do see not only on the primary endpoint of transfusion independence, but also as we think about the other endpoints.

    我認為我們如何考慮對數據進行更深入審查的一個例子是 Reblozyl 的獨立試驗。正如我們所傳達的,我們深入研究了數據,並且我們確實看到了具有臨床意義的影響,不僅在輸血獨立性的主要終點上,而且在我們考慮其他終點時也是如此。

  • And so based on that, we are right now planning to interact with the health agencies around the world to ensure that we give the best chance for the drug to be able to show its activity and provide a much-needed therapy for unmet medical need in anemia-associated myelofibrosis. And we'll continue to watch out if there are other opportunities for other molecules as we go through the rest of the year.

    因此,基於此,我們現在正計劃與世界各地的衛生機構進行互動,以確保我們能夠為該藥物提供最佳機會來顯示其活性,並為貧血相關骨髓纖維化中未滿足的醫療需求提供急需的治療方法。在接下來的一年裡,我們將繼續關注其他分子是否還有其他機會。

  • Thanks, Geoff.

    謝謝,傑夫。

  • Geoffrey Meacham - Analyst

    Geoffrey Meacham - Analyst

  • Thanks, guys.

    謝謝大家。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Yeah, sure. Next question, please, operator.

    是的,當然。接線員,請問下一個問題。

  • Operator

    Operator

  • Courtney Breen, Bernstein.

    考特尼·布林,伯恩斯坦。

  • Courtney Breen - Equity Analyst

    Courtney Breen - Equity Analyst

  • Hi, guys. Thanks so much for taking the call this morning. We really wanted to focus a little bit on kind of the macro pressures or the industry pressures that you guys are facing, and you announced recently the direct-to-consumer offering in conjunction with Pfizer.

    嗨,大家好。非常感謝您今天早上接聽電話。我們確實想稍微關註一下你們所面臨的宏觀壓力或產業壓力,而你們最近宣布與輝瑞合作推出直接面向消費者的產品。

  • Can you give us a bit more context on kind of why this felt like it was the right time to announce this deal? Was this a direct kind of mandate or agreement with this administration? And is this potentially a platform that you may look to utilize with any of your other products over time? And what kinds of products might be the right ones to fit into a platform like this?

    您能否向我們詳細介紹為什麼現在感覺是宣布這筆交易的最佳時機?這是與本屆政府的直接授權或協議嗎?隨著時間的推移,您是否有可能考慮將此平台與您的其他產品一起使用?什麼樣的產品才適合這樣的平台呢?

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Yeah. Thanks for the question, Courtney. Maybe I'll start, and then I'll turn it over to Adam.

    是的。謝謝你的提問,考特尼。也許我會開始,然後我會把它交給亞當。

  • We're pleased that we were able to implement this program with Pfizer. I think this administration has actually done a nice job highlighting the need to cut out the middleman from the US healthcare system. Remember, roughly about half of every dollar spent on a branded medicine goes to someone who took absolutely no R&D risk in the creation of that product. And the Eliquis direct-to-patient offering is a way for us to offer meaningful decreases in out-of-pocket costs for patients, increase transparency, and take a step, as the president has suggested, in cutting out traditional middlemen.

    我們很高興能夠與輝瑞公司合作實施該計劃。我認為本屆政府其實已經很好地強調了從美國醫療保健體系中剔除中間人的必要性。請記住,在品牌藥品上花費的每一美元中,大約有一半流向了那些在該產品的研發過程中完全沒有承擔任何研發風險的人。Eliquis 直接向患者提供藥物,讓我們能夠大幅降低患者的自付費用,提高透明度,並像總統建議的那樣,邁出擺脫傳統中間商的一步。

  • But maybe I'll have Adam speak to the program more specifically.

    但也許我會讓亞當更具體地談談這個計劃。

  • Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

    Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

  • Yeah. Thanks, Chris, and thanks, Courtney, for the question.

    是的。謝謝克里斯和考特尼提出的問題。

  • So as part of our commitment to increasing patient access to our medicines, following some of the conversations we've had with the administration, we announced with our Pfizer counterparts a few weeks ago that, beginning September 8, uninsured, underinsured, cash-paying US patients could purchase Eliquis directly through Eliquis 360 Support. So patients will be able to pay a discounted rate of over 50% less than the list price.

    因此,作為我們致力於增加患者獲得我們藥品機會的承諾的一部分,在與政府進行了一些對話之後,我們幾週前與輝瑞公司同行宣布,從 9 月 8 日開始,沒有保險、保險不足、現金支付的美國患者可以直接透過 Eliquis 360 Support 購買 Eliquis。因此,患者將能夠支付比標價低 50% 以上的折扣價。

  • As Chris was alluding to, we've heard from patients, policy makers, prescribers have all called for a simpler, more affordable, more transparent access. And now, patients will have full transparency into their costs, and it cuts out the middleman there. So we're launching this new direct-to-patient option as part of our commitment to increasing patient access and affordability.

    正如克里斯所暗示的,我們聽到病人、政策制定者和處方醫生都呼籲更簡單、更實惠、更透明的醫療服務。現在,患者可以完全透明地了解自己的費用,並且省去了中間商的環節。因此,我們推出這種新的直接面向患者的服務,作為我們致力於提高患者獲得醫療服務機會和負擔能力的一部分。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • The only other thing, Courtney, just to your question about whether there may be other opportunities, we're obviously going to continue to look within our own portfolio to see if there are opportunities where that makes sense. And I think we'll also continue to be looking across the industry for other potential opportunities. So more to come on that.

    考特尼,關於您是否還有其他機會的問題,唯一的另一件事是,我們顯然會繼續在我們自己的投資組合中尋找是否有意義的機會。我認為我們也將繼續在整個行業中尋找其他潛在機會。對此我們還有更多內容。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

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

    謝謝,克里斯。請讓我們進入下一個問題。

  • Operator

    Operator

  • Chris Schott, JPMorgan.

    摩根大通的克里斯·肖特。

  • Christopher Schott - Analyst

    Christopher Schott - Analyst

  • Great. Thanks so much. Just a two-parter on COBENFY. Maybe just first on the launch dynamics, I would love just to hear what you see as the primary hurdles to adoption for physicians at this point, given reimbursement, et cetera, in place.

    偉大的。非常感謝。這只是 COBENFY 上的兩個部分。也許先談談啟動動態,我很想聽聽您認為目前醫生採用該技術的主要障礙是什麼,包括報銷等。

  • And the second part was, as we look forward to the Alzheimer's psychosis results coming later this year, maybe just help frame out expectations in terms of the type -- magnitude of benefit you feel you need to show to see adoption here. And would the study alone be enough to support a filing? Thanks so much.

    第二部分是,我們期待今年稍後公佈的阿茲海默症精神病研究結果,這也許有助於明確您認為需要展示的益處類型和程度,才能在這裡得到採用。僅憑這項研究是否足以支持申請?非常感謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, Chris. Maybe I'll ask Adam to start on the first part and maybe hit on what the commercial threshold is for ADP. And then, Samit, you can give an update on where we are.

    謝謝你的提問,克里斯。也許我會請亞當開始第一部分,並談談 ADP 的商業門檻是多少。然後,薩米特,你可以告訴我們目前的情況。

  • Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

    Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

  • Thanks, Chris. COBENFY's performing in line with expectations, and we're now tracking over 2,000 TRxs on a weekly basis. We expect to see steady TRx growth as we continue to execute our plan. And we're still in the early stages of launch, and as we previously communicated, we knew it was going to take time to change what's been decades of entrenched prescribing behavior. And indeed, I think that's been the case.

    謝謝,克里斯。COBENFY 的表現符合預期,我們現在每週追蹤超過 2,000 個 TRx。隨著我們繼續執行計劃,我們預計 TRx 將穩定成長。我們仍處於發布的早期階段,正如我們之前所傳達的,我們知道改變幾十年來根深蒂固的處方行為需要時間。事實上,我認為情況確實如此。

  • Physician feedback continues to be very positive regarding COBENFY's differentiated profile. And what's encouraging is that the vast majority of physicians have indicated an intent to prescribe COBENFY. So we're making steady progress with adding a number of new trialists as we're growing trialists each week, but we definitely have an opportunity to continue to accelerate breadth and depth of prescribing. So let me talk a little bit about what we're doing and also some of what we're hearing.

    醫生對於 COBENFY 的差異化特性的回饋仍然非常積極。令人鼓舞的是,絕大多數醫生都表示有意開 COBENFY。因此,隨著每週試驗者人數的增加,我們在增加新試驗者數量方面取得了穩步進展,但我們肯定有機會繼續加快處方的廣度和深度。那麼讓我稍微談談我們正在做的事情以及我們聽到的一些消息。

  • First, we're increasing the size of our community field force to increase reach and frequency, as we know it takes multiple calls to change physician behavior. For your question, the most common question that we receive from physicians is how to switch, and we're focused on clarifying switching approaches from D2s to COBENFY through peer-to-peer initiatives, introducing real-world data, and we also have a Phase 4 switch study that reads out at the end of the year, I think all of which will help build physician confidence.

    首先,我們正在擴大社區外勤人員的規模,以增加覆蓋範圍和頻率,因為我們知道,改變醫生的行為需要多次呼叫。對於您的問題,我們從醫生那裡收到的最常見問題是如何轉換,我們專注於通過點對點計劃明確從 D2 到 COBENFY 的轉換方法,引入真實世界的數據,我們還有一項第 4 階段轉換研究將在年底公佈,我認為所有這些都將有助於建立醫生的信心。

  • And then finally, we're expanding into the hospital setting. So this is a planned sequence launch, first into the community, then into the hospital, and that opportunity to drive new patient starts, patients are typically maintained on treatment from the hospital, and then moved into the community. So in the hospitals, around 20% to 25% of NRxs initiated there. So based on all the leading indicators we're seeing, we're confident that COBENFY's going to be a big drug in schizophrenia and, longer term, will be fueled by additional indicators such as our Alzheimer's program.

    最後,我們將業務擴展到醫院環境。因此,這是一個有計劃的序列啟動,首先進入社區,然後進入醫院,並有機會推動新患者開始治療,患者通常在醫院接受治療,然後轉移到社區。因此,在醫院中,大約有 20% 到 25% 的 NRxs 是在醫院發起的。因此,根據我們看到的所有領先指標,我們相信 COBENFY 將成為治療精神分裂症的重要藥物,並且從長遠來看,還將受到阿茲海默症計畫等其他指標的推動。

  • So I'll turn it over to Samit to talk about the Alzheimer's program.

    因此我將把話題交給薩米特來談論阿茲海默症計畫。

  • Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

    Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

  • Yeah. Thanks Adam, and thank you, Chris, for the question as well.

    是的。謝謝亞當,也謝謝克里斯提出的問題。

  • So COBENFY, from our Alzheimer's disease perspective, we remain confident in the product and certainly are conducting all our clinical trials with that mindset, not only in the psychosis program, but also for agitation as well as cognition. For ADEPT-2, we're certainly looking forward to the database lock, and we remain blinded to that data at this time.

    因此,從阿茲海默症的角度來看,我們對 COBENFY 產品仍然充滿信心,並且肯定會以這種心態開展所有臨床試驗,不僅在精神病計畫中,而且在激動和認知方面也是如此。對於 ADEPT-2,我們當然期待資料庫鎖定,但目前我們對該資料仍然一無所知。

  • As Chris mentioned earlier during his prepared remarks, we are also reviewing our key studies to make sure that, internally, we give the highest probability of success to all of our programs. And specifically, as it relates to ADEPT-2, in preparation of that database lock, we are conducting the clinical trial site reviews. That could impact the timelines a bit, but with that said, we are still targeting the top-line data by the end of the year for ADEPT-2.

    正如克里斯之前在準備好的演講中提到的那樣,我們也在審查我們的關鍵研究,以確保在內部,我們所有的專案都具有最高的成功機率。具體來說,由於它與 ADEPT-2 相關,在準備資料庫鎖定時,我們正在進行臨床試驗現場審查。這可能會對時間表產生一些影響,但話雖如此,我們仍然瞄準在今年年底前獲得 ADEPT-2 的頂線數據。

  • As far as the filing is concerned, as I think has been mentioned already, we are conducting three studies in Alzheimer's disease psychosis: ADEPT-2, ADEPT-4, ADEPT-1. ADEPT-4 and ADEPT-1 will read out in 2026, and so two of the three studies need to be positive for us to be engaging the health authorities for filing and registration purposes. We are glad where we are in terms of our enrollments and looking forward to the data readouts.

    就申請而言,我認為已經提到過,我們正在對阿茲海默症精神病進行三項研究:ADEPT-2、ADEPT-4、ADEPT-1。ADEPT-4 和 ADEPT-1 將於 2026 年公佈,因此三項研究中的兩項需要取得積極結果,我們才能與衛生當局合作進行備案和註冊。我們對招生情況感到滿意,並期待數據讀數。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Great. Thanks, Samit. Next question, please.

    偉大的。謝謝,薩米特。請回答下一個問題。

  • Operator

    Operator

  • Evan Seigerman, BMO.

    埃文·西格曼(BMO)。

  • Evan Seigerman - Analyst

    Evan Seigerman - Analyst

  • Hey, guys. Thank you so much for taking my question. I wanted to touch on some of the rationale for partnering with BioNTech, and specifically what you saw in their PD-L1 VEGF bispecific. There's a lot of assets out there. What attracted you to the partnership with them? Maybe walk me through some of the differentiation, and how you can work with them to accelerate this to potentially the early, kind of in the class of assets. Thank you.

    嘿,大家好。非常感謝您回答我的問題。我想談談與 BioNTech 合作的一些理由,特別是您在他們的 PD-L1 VEGF 雙特異性中看到的內容。那裡有很多資產。是什麼吸引您與他們合作?也許可以向我介紹其中的一些區別,以及如何與他們合作來加速這一進程,使其成為潛在的早期資產類別。謝謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Sure. Maybe I'll just say one word, and then I'll turn it over to both Adam and Samit.

    當然。也許我只會說一個詞,然後我會把它交給亞當和薩米特。

  • First, as I mentioned in the prepared remarks, we're excited about the opportunity that we have with BioNTech. We think this is going to be a really value-added partnership for us going forward. One of the things that was particularly attractive was this is an asset that is in a position to be either first or second as this technology evolves. And we know from our experience in immuno-oncology with OPDIVO that that positioning in the marketplace is really important. And so that was one of the factors among many that attracted us to the BioNTech partnership.

    首先,正如我在準備好的發言中提到的,我們對與 BioNTech 合作的機會感到非常興奮。我們認為,這對我們未來發展而言,將會是一個真正增值的合作夥伴關係。特別有吸引力的一點是,隨著技術的發展,這項資產有可能成為第一或第二。我們從 OPDIVO 在免疫腫瘤學領域的經驗中了解到,市場定位非常重要。這是吸引我們與 BioNTech 合作的眾多因素之一。

  • But maybe, Adam, you and Samit can pick it up from there.

    但是也許,亞當,你和薩米特可以從那裡得到答案。

  • Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

    Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

  • Yeah. Thanks for the question, Evan.

    是的。謝謝你的提問,埃文。

  • So our partnership with BioNTech, I think, has the potential to enhance our growth profile in the back end of the decade into the 2030s while strengthening and diversifying our oncology portfolio. As you know, we've been a leader in IO now for well over a decade, and we do believe that BNT327 has the potential to become a new standard of care for many patients and could transform the current landscape as a backbone of cancer treatment.

    因此,我認為,我們與 BioNTech 的合作有可能在 2030 年代後期提升我們的成長前景,同時加強和多樣化我們的腫瘤學產品組合。如你所知,十多年來我們一直是 IO 領域的領導者,我們確實相信 BNT327 有潛力成為許多患者的新護理標準,並可以改變當前癌症治療的模式。

  • So Chris talked about the importance and certainly a learning from OPDIVO. Coming to the market and being able to leapfrog to go into a first or second position across tumors is critical. So our focus, and Samit will touch on this, is around speed to market. We also have the infrastructure in place. We can leverage our capabilities that we've built over years, commercializing out three IO agents. And so by leveraging our leading commercial and operational capabilities with BioNTech's scientific expertise, we can help accelerate and broaden the development of the program and explore new indications to maximize the potential.

    因此,克里斯談到了 OPDIVO 的重要性以及它所帶來的學習意義。進入市場並能夠跨越式地佔據腫瘤治療領域第一或第二的位置是至關重要的。因此我們的重點(Samit 將會談到這一點)是上市速度。我們也擁有完善的基礎設施。我們可以利用多年來建立的能力,將三種 IO 代理商業化。因此,透過利用我們領先的商業和營運能力以及 BioNTech 的科學專業知識,我們可以幫助加速和擴大該計劃的發展,並探索新的適應症以最大限度地發揮潛力。

  • Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

    Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

  • Yeah. And just to build on what Adam just said, with two validated targets on a bispecific, PD-L1 and VEGF, the specificity of delivering the drug to the tumor because of expression of PD-L1, that brings a differentiation compared to the PD-1 VEGF inhibitors.

    是的。基於 Adam 剛才所說的,雙特異性抗體有兩個經過驗證的靶點,即 PD-L1 和 VEGF,由於 PD-L1 的表達,將藥物輸送到腫瘤的特異性,與 PD-1 VEGF 抑制劑相比有所區別。

  • Of course, we'll need to continue to watch out the evolution of the data across the tumor types that these drugs are being explored in, but certainly very excited to provide our help as well as support and collaboration because of our footprint in 50-plus countries to conduct clinical trials. Initiation of the clinical trials, certainly, as Chris mentioned earlier, is in small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer. But there's a large CDP that is being built right now, and we'll be able to share that later in the year.

    當然,我們需要繼續關注這些藥物所針對的腫瘤類型的數據演變,但由於我們的足跡遍布 50 多個國家開展臨床試驗,我們非常高興能夠提供幫助、支持和合作。當然,正如克里斯之前提到的,臨床試驗的啟動是針對小細胞肺癌、非小細胞肺癌和三陰性乳癌。但目前正在建造一個大型 CDP,我們將在今年稍後與大家分享。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Great. Thanks for the background. Next question, please.

    偉大的。謝謝你的背景介紹。請回答下一個問題。

  • Operator

    Operator

  • Luisa Hector, Berenberg.

    路易莎·赫克托(Luisa Hector),貝倫貝格(Berenberg)。

  • Luisa Hector - Equity Analyst

    Luisa Hector - Equity Analyst

  • Hello. Thank you for taking my questions. And maybe a quick thank you to Samit for all the insightful dialog over the years, and good luck. So I wonder if you could quantify the stocking and any growth to net impact. Quite a few mentions, but I don't know if you have the numbers year on year as well as the Q2 sequential.

    你好。感謝您回答我的問題。最後,我想快速感謝 Samit 多年來的富有洞察力的對話,祝你好運。所以我想知道您是否可以量化庫存和任何成長對淨影響。提到了不少,但我不知道您是否有同比數據以及第二季度環比數據。

  • And then perhaps on the immunology collaboration with Bain, the spin-off, just a little bit more color on the rationale for those particular assets going out. Will you have opt-in rights? And are there any other therapy areas where this externalization approach might be useful? Thank you.

    然後,也許在與貝恩的免疫學合作、分拆方面,對這些特定資產剝離的理由進行更詳細的闡述。您有選擇加入的權利嗎?這種外化方法是否也可能適用於其他治療領域?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. I'll ask David to take the stocking and the first part of the immunology question. Then maybe, Samit, you can chime in as well.

    謝謝你的提問,路易莎。我會請大衛拿著長襪回答免疫學問題的第一部分。那麼,薩米特,也許你也可以加入。

  • 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. On the raising our guidance by $700 million, most of that's driven by demand. And as we take a look at it, about a little less than $200 million was related to FX, and the majority of that is in our legacy portfolio and in our IO portfolio, which is where more of that business is relative to our growth portfolio is outside the US. And the remaining $500 million is pretty much evenly split between the growth portfolio, the pervasive strength that we saw across many of the brands that I talked about in the prepared remarks.

    是的。我們將指導金額提高 7 億美元,其中大部分是由需求推動的。我們看一下,大約有將近 2 億美元與外匯有關,其中大部分在我們的傳統投資組合和 IO 投資組合中,相對於我們的成長投資組合,這些業務的大部分在美國以外。剩下的 5 億美元則基本上平均分配給成長投資組合,也就是我在準備好的發言中提到的許多品牌所展現出的普遍實力。

  • And then as I talked about also, we raised the REVLIMID guidance by $500 million, but that will be offset -- a good portion of that will be offset by more erosion we're seeing with the ABRAXANE, SPRYCEL, and POMALYST. But overall, it's a strong raise. We're really pleased with the performance of the growth portfolio and seeing that going into the remainder of the year.

    然後,正如我所說的,我們將 REVLIMID 指導金額提高了 5 億美元,但這將被抵消——其中很大一部分將被我們看到的 ABRAXANE、SPRYCEL 和 POMALYST 的進一步侵蝕所抵消。但總體而言,這是一次強勁的加薪。我們對成長投資組合的表現感到非常滿意,並期待其在今年剩餘時間內繼續保持良好的表現。

  • Your last question, there was very little stocking that we saw within the quarter. So this is good underlying demand growth.

    您的最後一個問題是,我們在本季看到的庫存很少。因此,這是良好的潛在需求成長。

  • Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

    Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

  • And just to add to what you asked and what David just said, from an immunology perspective, we've always talked about three elements of targeting the immunological diseases: inflammation, resetting the immune system, and then creating a homeostasis. And within the inflammation part, we do have Sotyktu, which is already approved in psoriasis. We recently submitted around the world applications for psoriatic arthritis, and we are pursuing additional indications in SLE and Sjögren's syndrome. We have LPA1 in IPF and PPF. As we heard before, IPF will read out next year.

    補充一下您所問的問題以及 David 剛才所說的,從免疫學的角度來看,我們一直在談論針對免疫疾病的三個要素:發炎、重置免疫系統,然後建立體內平衡。在發炎方面,我們有 Sotyktu,它已被批准用於治療牛皮癬。我們最近向世界各地提交了治療銀屑病關節炎的申請,並且正在尋求治療系統性紅斑狼瘡 (SLE) 和乾燥症 (Sjögren's Syndrome) 的更多適應症。IPF 和 PPF 中都有 LPA1。正如我們之前所聽到的,IPF 將於明年宣讀。

  • But what we are truly really excited about is the resetting of the immune system through the use of cell therapies. And that's where the emerging data is quite exciting, as we think about SLE, and more data that will be emerging in systemic sclerosis, myositis, MS, as well as myasthenia gravis. And with the initiation of the pivotal trial, now we have to enroll that as quickly as possible and, in a couple years, start to see how we can impact that disease in a positive way.

    但真正讓我們興奮的是透過使用細胞療法重置免疫系統。這就是新興數據非常令人興奮的地方,當我們考慮 SLE 時,以及更多系統性硬化症、肌炎、MS 以及重症肌無力中將出現的數據。隨著關鍵試驗的啟動,我們現在必須盡快招募患者,並在幾年後開始觀察我們如何以積極的方式影響這種疾病。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • And just to sort of dovetail back on the rationale for this particular agreement with Bain and how we would think about this going forward, the creation of the new company centers around five assets. Three of those assets are clinical stage, two are Phase 1-ready. We have been discussing, as you know, for the better part of the last 18 months, being diligent to Samit's point around portfolio prioritization, focusing on those areas where we have a right to win. And as you do that, there are naturally projects that may not make the pay line for us, but still have compelling science or commercial opportunity. And this agreement is a nice way for us to continue to progress those assets while retaining the ability to benefit from any upside.

    為了與貝恩達成這項特定協議的理由以及我們未來對此的看法相吻合,新公司的成立圍繞著五項資產。其中三項資產處於臨床階段,兩項已準備好進入第一階段。如您所知,在過去 18 個月的大部分時間裡,我們一直在討論薩米特關於投資組合優先順序的觀點,重點關注我們有權取勝的領域。當你這樣做的時候,自然就會有一些項目可能無法為我們帶來回報,但仍然具有引人注目的科學或商業機會。這項協議對於我們繼續推動這些資產並保留從任何上行趨勢中獲益的能力來說是一個很好的方式。

  • And of course, we'll continue to look at innovative ways to do precisely that as we go forward. Whether or not we'll be able to leverage a mechanism like this remains to be seen, but we really like this particular structure for these assets and we're happy to have kicked this off with Bain.

    當然,我們將繼續尋找創新方法來實現這一目標。我們是否能夠利用這樣的機制還有待觀察,但我們真的很喜歡這些資產的這種特殊結構,我們很高興能與貝恩一起啟動這一進程。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Great. Thank you. Operator, next question, please.

    偉大的。謝謝。接線員,請問下一個問題。

  • Operator

    Operator

  • David Amsellem, Piper Sandler.

    大衛·阿姆塞勒姆、派珀·桑德勒。

  • David Amsellem - Senior Research Analyst

    David Amsellem - Senior Research Analyst

  • Thanks. I wanted to ask about Camzyos and particularly competitive dynamics with a second myosin inhibitor potentially entering the market by the end of the year or early next year. I guess my question here is, how are you thinking about your ability to drive a steady cadence of new starts with the additional competition, particularly to the extent that aficamten's REMS potentially is less onerous in terms of echo monitoring? Just how are you thinking about that and your ability to grow the asset, not really this year, but longer term as competitive dynamics intensify? Thank you.

    謝謝。我想詢問有關 Camzyos 的問題,尤其是第二種肌球蛋白抑制劑可能在今年年底或明年年初進入市場的競爭動態。我想我的問題是,您如何看待自己在面臨額外競爭的情況下推動新起點穩定發展的能力,尤其是在 aficamten 的 REMS 在迴聲監測方面可能不那麼繁重的情況下?您如何看待這個問題以及您增加資產的能力,不僅是今年,而且是隨著競爭態勢加劇而長期來看?謝謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, David. We'll ask Adam to handle that one.

    謝謝你的提問,大衛。我們會讓亞當來處理這個問題。

  • Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

    Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

  • Yes, David. So we've continued to deliver strong growth with Camzyos. We're very pleased with performance as we've continued to increase new patient starts. And we've established a strong revenue base and we expect that to continue from the expansion of our prescriber base coupled with high persistency. The feedback on our REMS label change has been very positive that eases the burden of echo requirements for both patients and physicians. And although it's still early days post the label change, we've seen physicians treat more patients at the COEs and we're also making very good progress expanding in the community.

    是的,大衛。因此,我們繼續透過 Camzyos 實現強勁成長。我們對業績感到非常滿意,因為我們的新患者數量持續增加。我們已經建立了強大的收入基礎,我們預計,隨著處方醫生基礎的擴大和高持久性,這種收入基礎將得以延續。我們對 REMS 標籤變更的回饋非常積極,這減輕了患者和醫生的迴聲要求的負擔。儘管標籤更改後仍處於早期階段,但我們已經看到醫生在 COE 治療了更多的患者,並且我們在社區擴展方面也取得了非常好的進展。

  • As far as aficamten, we don't see any meaningful clinical differentiation there. Camzyos has set a very high bar for efficacy and safety. We have compelling real-world data across now thousands of patients and we're continuing to grow that every week. And it's going to be important to see what their label looks like. But we remain focused on driving growth by broadening our prescriber base from the COEs into the community. And we will be prepared for aficamten when it comes to market, and we will maintain a consistent view that we will remain leaders in this space.

    就 aficamten 而言,我們沒有看到任何有意義的臨床差異。Camzyos 對功效和安全性設定了非常高的標準。我們現在擁有數千名患者的令人信服的真實世界數據,並且每週都在增加這些數據。看看他們的標籤是什麼樣子的很重要。但我們仍然專注於透過將我們的處方者群體從 COE 擴展到社區來推動成長。當市場進入時,我們將做好準備,並且我們將始終堅信我們將保持在這一領域的領先地位。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Great. Thanks, Adam. Let's move to the next question.

    偉大的。謝謝,亞當。我們來討論下一個問題。

  • Operator

    Operator

  • Dave Risinger, Leerink Partners.

    Dave Risinger,Leerink Partners。

  • David Risinger - Analyst

    David Risinger - Analyst

  • Thanks very much, and congrats on the strong financial performance. So Chris, you had highlighted Milvexian first when you discussed major pipeline candidates to watch in coming years. And since the Street consensus only models 2032 sales of $2.3 billion, that reflects a lot of skepticism. So if you and maybe Samit could just help us better understand what you think investors underappreciate about Milvexian's likelihood of success in secondary stroke, ACS, and AF. Thanks so much.

    非常感謝,並祝賀您取得強勁的財務業績。克里斯,當您討論未來幾年值得關注的主要管道候選人時,您首先強調了米爾維西安。由於華爾街的共識僅預測 2032 年的銷售額為 23 億美元,反映出許多懷疑態度。因此,如果您和 Samit 可以幫助我們更好地理解投資者為何低估了 Milvexian 在治療繼發性中風、ACS 和 AF 方面成功的可能性。非常感謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Yeah. Thanks for the question, Dave. Why don't we have Samit, you start, and then, Adam, maybe you can speak to commercial opportunity.

    是的。謝謝你的提問,戴夫。為什麼我們不先請薩米特 (Samit) 開始,然後亞當 (Adam),也許你可以談談商業機會。

  • Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

    Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

  • Yeah. Thank you for the question, David. Of Milvexian, we've spoken before about the way we have thought about the development plan. There were two well-conducted studies to define the doses. And the doses we differentiated as a single agent versus combination of the background of dual antiplatelet therapy.

    是的。謝謝你的提問,大衛。關於 Milvexian,我們之前曾談到我們對開發計劃的看法。有兩項精心進行的研究來確定劑量。我們將劑量區分為單一藥物和合併雙重抗血小板治療。

  • For atrial fibrillation, we chose the dose of 100 milligrams BID. And you saw the results from the competitor program where the doses did not hit, the overall event rate was much higher. We have the DMC that continues to observe our data sets. We've enrolled the 20,000 patients in the AF trial. We look forward to the outcomes, but certainly, the overall event rate remains low in that program at this time.

    對於心房顫動,我們選擇 100 毫克 BID 的劑量。而且您可以看到競爭對手的計劃的結果,其中劑量沒有達到,總體事件發生率要高得多。我們有 DMC 持續觀察我們的資料集。我們已經招募了 20,000 名患者參與 AF 試驗。我們期待結果,但可以肯定的是,目前該計劃的總體事件發生率仍然很低。

  • For secondary stroke prevention and ACS, again, those trials are enrolling really well. And we have chosen the doses of 25 milligrams BID to be able to give a safe region of dosing these patients because of the background of dual antiplatelet therapy. Again, DMC continues to look at the data and the studies continue, and next year, we will be reading out. So I think there is an underappreciation of that differential dosing patterns that we've chosen for the two and what we observed in the Phase 2 programs in TKR, as well as SSP, that supported these studies.

    對於二級中風預防和 ACS,這些試驗的招募情況非常好。並且,由於雙重抗血小板治療的背景,我們選擇了 25 毫克 BID 的劑量,以便為這些患者提供安全的給藥範圍。再次,DMC 將繼續查看數據並繼續進行研究,明年我們將讀出結果。因此,我認為人們低估了我們為這兩種藥物選擇的差異化給藥模式,以及我們在支持這些研究的 TKR 和 SSP 第 2 階段項目中觀察到的情況。

  • Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

    Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

  • From a commercial perspective, Dave, this is a significant commercial opportunity across all three indications. We think this has multi-blockbuster potential.

    戴夫,從商業角度來看,這對所有三個適應症來說都是一個重要的商業機會。我們認為這具有成為多部大片的潛力。

  • So in atrial fibrillation, the fear of bleeding continues to be the main reason why clinicians hold back from using Factor XIa in more patients. Approximately 40% of patients still remain untreated or undertreated, leaving them at risk for a stroke. And we know that's due to safety. We believe that a differentiated bleeding profile can drive demand in this untreated, undertreated patient population.

    因此,在心房顫動中,對出血的恐懼仍然是臨床醫生不願意在更多患者身上使用 XIa 因子的主要原因。約 40% 的患者仍未接受治療或治療不足,面臨中風的風險。我們知道這是出於安全考量。我們相信,差異化的出血特徵可以推動這個未接受治療或治療不足的患者群體的需求。

  • In ACS, also a high unmet need remains. One in three ACS patients are going to experience a second cardiac event within a year. And we know there's been very limited success in combining Factor XIa with antiplatelet therapies due to bleeding profile. So we expect to show meaningful improvements on top of antiplatelet therapy.

    在 ACS 中,仍存在大量未滿足的需求。三分之一的 ACS 患者將在一年內經歷第二次心臟事件。我們知道,由於出血情況,將 XIa 因子與抗血小板療法結合的成功率非常有限。因此,我們希望在抗血小板治療的基礎上取得有意義的進展。

  • And finally, in secondary stroke prevention, similarly around 25% of stroke survivors experience additional preventable strokes. And so you saw the data, the Phase 2 data that reinforced Milvexian's differentiated profile, that showed a clinically meaningful reduction in recurrent strokes. So we believe there is a significant opportunity to combine antiplatelets with these new agents like Milvexian and are not indicated to the risk of bleeding. So taken together, we're very excited about this program.

    最後,在二級中風預防中,同樣約有 25% 的中風倖存者會經歷其他可預防的中風。因此,您看到了數據,第 2 階段的數據強化了 Milvexian 的差異化特徵,表明復發性中風的發生率在臨床上顯著減少。因此,我們認為將抗血小板藥物與 Milvexian 等新藥物結合具有很大的潛力,而且不會帶來出血風險。總的來說,我們對這個項目感到非常興奮。

  • David Risinger - Analyst

    David Risinger - Analyst

  • Thanks very much.

    非常感謝。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Great. Next question, please.

    偉大的。請回答下一個問題。

  • Operator

    Operator

  • Asad Haider, Goldman Sachs.

    高盛的阿薩德·海德爾 (Asad Haider)。

  • Asad Haider - Analyst

    Asad Haider - Analyst

  • Great. Thanks for taking the question, and congratulations on the results. Two quick ones. First, just with respect to the cost optimization program, can you just elaborate on how you're thinking about the pushes and pulls related to capital needs, given that you also have to support expenditures, like the $40 billion announced CapEx, as well as large and potentially costly development programs related to expediting the PD-L1 VEGF Phase 3 clinical trials in the wake of the BioNTech deal, and then you also have the debt paydown in BD. So any updated thoughts on costs and margins as it relates to your goals of shortening the depth of earnings, the earnings trough relative to these new investments and the ultimate return to growth would be helpful.

    偉大的。感謝您的提問,並祝賀您所取得的成果。兩個簡單的。首先,僅就成本優化計劃而言,您能否詳細說明您如何考慮與資本需求相關的推拉因素,因為您還必須支持支出,例如宣布的 400 億美元資本支出,以及與加快 BioNTech 交易後 PD-L1 VEGF 第 3 期臨床試驗相關的大型且可能成本高昂的開發計劃,然後您還必須償還 BD 的債務。因此,任何有關成本和利潤率的最新想法,因為它與縮短盈利深度、相對於這些新投資的盈利低谷以及最終的增長回報的目標有關,都會有所幫助。

  • And then two, just perhaps just very quickly on ADEPT-2. Just given that's imminent, just remind us on how we should be thinking about the view across from that trial to ADEPT-1 and ADEPT-4 in 2026. Thank you.

    然後第二點,也許很快就會談到 ADEPT-2。鑑於這一切即將發生,請提醒我們,我們應該如何思考從那次試驗到 2026 年 ADEPT-1 和 ADEPT-4 的觀點。謝謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, Asad. Maybe I'll ask David to start, and then, Samit, you can quickly hit on ADEPT-2.

    謝謝你的提問,阿薩德。也許我會讓大衛開始,然後,薩米特,你可以快速進入 ADEPT-2。

  • 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, thanks for the question. A couple of things. I think you hit on multiple points there. Cash allocation, capital allocation, but as well as margins as it relates to our productivity initiatives.

    是的。阿薩德,謝謝你的提問。有幾件事。我認為您提到了多個要點。現金分配、資本分配,以及與我們的生產力計畫相關的利潤率。

  • And just as a reminder, we initiated a $1.5 billion initiative back at the end of '23, knowing that we had several business development deals that we had at the fund, and that was $1.5 billion. We completed finding those funds last year and reallocated that to the programs that we talked about, particularly around COBENFY with the multiple clinical programs that we have in place there, but as well as RayzeBio and funding those types of investments. And also, don't forget, SystImmune, very important program that we have there that we're funding that clinical program.

    提醒一下,我們在 23 年底發起了一項 15 億美元的計劃,因為我們知道我們在該基金中有幾筆業務發展交易,而這筆資金是 15 億美元。我們去年完成了這些資金的籌集,並將其重新分配給我們討論過的項目,特別是圍繞 COBENFY 的項目,我們在那裡實施了多個臨床項目,以及 RayzeBio 和資助這些類型的投資。另外,別忘了,SystImmune 是我們的一個非常重要的項目,我們正在資助這個臨床項目。

  • Then this year, we announced a $2 billion strategic productivity initiative, which a lot of confidence in being able to deliver that. We're going to deliver $1 billion of that this year, which we said that $2 billion by 2027 will drop to the bottom line. But what that also does is that helps our cash flow position. It gives us more capital to allocate towards business development, as well as enables us to do up-invest. And I think this quarter is a great example of that, where we saw some opportunities, the number one BioNTech deal, funding those clinical studies, as you heard from someone around, particularly around lung and breast.

    今年,我們宣布了一項 20 億美元的策略生產力計劃,我們對實現這一目標充滿信心。我們今年將交付 10 億美元,我們說到 2027 年將實現 20 億美元的利潤。但這也有助於我們的現金流狀況。它為我們提供了更多的資金用於業務發展,也使我們能夠進行追加投資。我認為本季就是一個很好的例子,我們看到了一些機會,第一大 BioNTech 交易為那些臨床研究提供資金,正如你從周圍人那裡聽到的,特別是在肺癌和乳腺癌方面。

  • But also, what that enabled us to do is Adam had some up-investment opportunities in the growth portfolio, and we were able to invest behind those. So we feel really good about the capability that we're building here and the ability to reallocate resources that are going to drive growth and strengthen the long-term growth profile of the company at the end of the decade.

    但同時,這也使我們能夠讓亞當在成長投資組合中獲得一些追加投資機會,並且我們能夠對這些機會進行投資。因此,我們對我們在這裡建立的能力以及重新分配資源的能力感到非常滿意,這些資源將推動成長並加強公司在下一個十年的長期成長前景。

  • And the last thing I'd say is, we have a significant number of Phase 3 programs that are ongoing right now. And as Chris talked about, over the next 18 to 24 months, we have iberdomide, mezigdomide Phase 3 programs coming down. We also talked about Milvexian Phase 3 programs that are reading out at the end of next year and AFib reading out. So we have a lot of Phase 3 programs that are coming down, which enables us to reallocate those to the multiple Phase 3 programs we'll be doing with COBENFY and with the BioNTech partnership. So I'm just really proud of the entire team and the amount of effort and these productivity initiatives in order to fund growth.

    最後我想說的是,我們目前正在進行大量第三階段專案。正如克里斯所說,在接下來的 18 到 24 個月內,我們將推出 iberdomide 和 mezigdomide 第三階段專案。我們還討論了將於明年年底完成的 Milvexian 第三階段計劃以及 AFib 讀數。因此,我們有許多即將完成的 3 期項目,這使我們能夠將它們重新分配給我們將與 COBENFY 和 BioNTech 合作開展的多個 3 期項目。因此,我為整個團隊以及他們為資助成長所付出的努力和這些生產力舉措感到非常自豪。

  • Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

    Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

  • Yeah. And just to take on the second question around ADEPT-2, ADEPT-1, ADEPT-4, remember ADEPT-1 is a study for relapse prevention, which is now a 36-week study because 12 weeks of open-label period and then the responders are randomized to then look for placebo versus the continuation of COBENFY to see when the relapse occurs. And then ADEPT-4 is similar to ADEPT-2, except in ADEPT-4 we are paying more attention to enrollment of biomarker-positive patients as well.

    是的。僅回答有關 ADEPT-2、ADEPT-1、ADEPT-4 的第二個問題,請記住 ADEPT-1 是一項複發預防研究,現在是一項為期 36 週的研究,因為有 12 週的開放標籤期,然後對響應者進行隨機分配,然後尋找安慰劑與繼續使用 COBENFY 的比較,以觀察復發何時發生。ADEPT-4 與 ADEPT-2 類似,不同之處在於 ADEPT-4 我們更重視生物標記陽性患者的招募。

  • So overall, as I said earlier, two of the three trials are required in terms of positivity to be able to engage the authorities and discuss the approvals. So we are truly excited about that, looking forward to the top line at the end of the year for ADEPT-2 and then next year will be ADEPT-1 and ADEPT-4.

    因此,總的來說,正如我之前所說,三項試驗中需要有兩項具有積極性,才能與當局接洽並討論批准事宜。因此,我們對此感到非常興奮,期待今年年底推出 ADEPT-2,然後明年推出 ADEPT-1 和 ADEPT-4。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Great. Thanks, Samit. Let's move to the next question, please.

    偉大的。謝謝,薩米特。請讓我們進入下一個問題。

  • Operator

    Operator

  • Seamus Fernandez, Guggenheim Securities.

    古根漢證券公司的謝默斯·費爾南德斯。

  • Seamus Fernandez - Equity Analyst

    Seamus Fernandez - Equity Analyst

  • Thanks so much for the question. So I just wanted to get a better sense. It sounds like the trajectory for COBENFY continues to be quite robust from your perspective. Historically, you've talked about other relative launches like the launch of cariprazine as a good relative marker. Just wanted to get a sense of if that relative comp continues to be sort of a focus point for Bristol right now and where you see the incremental meaningful opportunities to accelerate those scripts. Is it more in gaining access to the Medicare population? Or is it in additional indications as kind of the next meaningful leg of growth to really drive towards that relative comp of cariprazine?

    非常感謝您的提問。所以我只是想獲得更好的理解。從您的角度來看,COBENFY 的發展軌跡似乎仍然相當強勁。從歷史上看,您曾談到其他相關產品的推出,例如卡利拉嗪的推出,就是一個很好的相關標誌。只是想了解相對補償是否繼續成為布里斯托爾目前的關注點,以及您是否看到了加速這些腳本的漸進式有意義的機會。這是否更有利於獲得醫療保險族群?或者它是否具有附加適應症,可以作為下一個有意義的成長階段,真正推動卡利拉嗪的相對成長?

  • And then just a quick second question, really just kind of hoping to better understand how sustainable the spend is here relative to sales. It seems more like you're kind of modeling the spend relative to future sales to then be consistent with where the sales are likely to kind of trough. Is that the right way to think about it? Or do you actually think that this is a sustainable sort of margin threshold within the context of Bristol-Myers Squibb? Thanks so much.

    然後只是一個簡單的第二個問題,實際上只是希望更了解這裡的支出相對於銷售額的可持續性。這看起來更像是在對未來銷售額相關的支出進行建模,以便與銷售額可能達到的低穀保持一致。這是正確的思考方式嗎?或者您實際上認為這是百時美施貴寶公司可持續的利潤門檻嗎?非常感謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, Seamus. Maybe I'll have Adam start and then David from there.

    謝謝你的提問,Seamus。也許我會讓亞當開始,然後大衛再開始。

  • Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

    Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer

  • Yeah. Seamus, thanks for the question. And as I said previously, we expect to see continued steady TRx growth as we execute the plan that I outlined. COBENFY is tracking far ahead of all branded schizophrenia launch benchmarks. So we've now achieved over 45,000 TRxs since launch. And I think the big opportunity is to continue to change the treatment paradigm and unlock this entrenched prescribing behavior that has existed now for decades. And so that's why we are, in fact, focusing on driving number of -- increasing number of trial lists, depth and breadth of prescribing.

    是的。謝默斯,謝謝你的提問。正如我之前所說,隨著我們執行我概述的計劃,我們預計 TRx 將繼續穩定成長。COBENFY 的追蹤速度遠遠領先所有品牌精神分裂症藥物的發布基準。自推出以來,我們現在已經實現了超過 45,000 個 TRxs。我認為最大的機會是繼續改變治療模式並解開幾十年來根深蒂固的處方行為。這就是為什麼我們實際上專注於增加試驗清單的數量、處方的深度和廣度。

  • What I look at on a weekly basis is how are we doing in adding number of writers. What's our depth and breadth of prescribing? What's the intent to prescribe? All those leading indicators we see are very, very positive. There's not a great analog, to be frank, since there's been nothing in this space for so long, but we're very pleased with what we're seeing thus far. And based on everything that we continue to see and hear from physicians, we're confident that COBENFY is going to be a big drug in schizophrenia.

    我每週都會關注我們在增加作家數量方面做得如何。我們的處方深度和廣度如何?開藥的目的是什麼?我們看到的所有這些領先指標都非常非常積極。坦白說,由於這個領域已經很久沒有出現任何類似的東西了,所以沒有很好的類似物,但我們對目前看到的情況感到非常滿意。根據我們不斷從醫生那裡看到和聽到的一切,我們相信 COBENFY 將成為治療精神分裂症的強大藥物。

  • The last thing that I'll mention is, just every week, we get feedback from physicians and patients. And just last week, we received a feedback from a physician that said, he stopped the medicine for the patient and started on COBENFY. And now, the patient's thinking about his future. He's including signing up for a class with improvements in attention, judgment, and insight.

    我要提到的最後一件事是,每週我們都會收到醫生和病人的回饋。就在上週,我們收到一位醫生的回饋,說他停止了給病人服用該藥,並開始服用 COBENFY。現在,病人正在考慮他的未來。他還報名了一個可以提高注意力、判斷力和洞察力的課程。

  • And that's just a small sample of what we hear every single week from physicians and patients, so again, increasing our confidence that this is going to be a big drug in schizophrenia. As you heard from Chris, Samit, David, and myself, longer term, this product is going to be multi-billion dollars fueled by additional indications.

    這只是我們每週從醫生和患者那裡聽到的一小部分訊息,因此,這再次增強了我們的信心,並相信這將成為治療精神分裂症的強大藥物。正如克里斯、薩米特、大衛和我所說的那樣,從長遠來看,該產品將透過額外的適應症實現數十億美元的價值。

  • 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

  • And Seamus, thanks for the question on margins. A couple things just to keep in mind. One, when we think about operating margins, we have a tremendous amount of financial flexibility. A big part of that's driven by our strategic productivity initiatives that we demonstrated, not only the $1.5 billion that we reallocated to our growth drivers last year, but the additional $2 billion of savings we're driving by '27.

    謝默斯,謝謝你關於利潤率的問題。有幾件事要記住。首先,當我們考慮營業利潤率時,我們擁有巨大的財務彈性。這在很大程度上是由我們所展示的策略生產力措施所推動的,不僅是去年我們重新分配給成長動力的 15 億美元,還有到 27 年我們額外節省的 20 億美元。

  • But also, let's not forget gross margins. We're going through a period right now of gross margin declines as some of our higher legacy margin products like REVLIMID and POMALYST come down have provided gross margin pressures. But then on the other side, as time progresses over the next few years, you're going to see gross margins will begin to improve, driven by two things. One is our growth portfolio now is over 54% of our total business. That portfolio, the average gross margin of that is higher than our company average today. So that's going to be accretive.

    但同時,我們也不要忘記毛利率。我們目前正經歷毛利率下降的時期,因為我們的一些高利潤傳統產品(如 REVLIMID 和 POMALYST)的銷售下降給毛利率帶來了壓力。但另一方面,隨著未來幾年時間的推移,你會看到毛利率將開始提高,這主要受兩件事的推動。一是我們的成長投資組合現在占我們總業務的54%以上。該投資組合的平均毛利率高於我們公司目前的平均值。所以這將會是增值的。

  • And obviously, with the significant growth we're seeing in that portfolio, that's going to be accretive to our gross margins. But also recall, we've guided Eliquis, and as that comes down and goes generic in '28, that's another factor that will really help our gross margins improve as we go towards the back half of the decade. So we feel really good about being able to manage the productivity of this company.

    顯然,隨著我們看到該投資組合的顯著成長,這將會增加我們的毛利率。但也要記住,我們已經指導了 Eliquis,隨著 28 年 Eliquis 的降價和通用化,這是另一個真正有助於我們在 2020 年前後提高毛利率的因素。因此,我們對能夠管理這家公司的生產力感到非常高興。

  • The other thing I would say, though, is what Chris and I have consistently said, is we're going to continue to invest in the long-term growth drivers of the company. And I think you saw that this quarter, and we'll continue to do that as we see opportunities. And also, as I just said earlier, if you just look at the natural progression of our development spend, we have many programs that are coming off as we're up-investing in COBENFY and BioNTech.

    不過,我想說的另一件事是克里斯和我一直在說的,我們將繼續投資於公司的長期成長動力。我想您在本季度已經看到了這一點,並且我們會在看到機會時繼續這樣做。而且,正如我之前所說,如果你只看我們開發支出的自然增長,你會發現隨著我們對 COBENFY 和 BioNTech 的投資增加,許多項目正在陸續啟動。

  • So what Samit and Adam have been able to do is reallocate resources from older brands to new brands. And Eliquis is a great example on the commercial side of that. We're able to move resources from Eliquis to Camzyos and eventually to Milvexian. I think OPDIVO is another example of that, where as BioNTech -- as we bring 327 to the marketplace, we'll be able to reallocate resources from OPDIVO to that. So strategically, we're being really smart about where we're driving growth and being able to reallocate resources to those growth opportunities.

    因此,薩米特和亞當能夠做的就是將資源從舊品牌重新分配到新品牌。Eliquis 就是商業方面的一個很好的例子。我們能夠將資源從 Eliquis 轉移到 Camzyos,最終轉移到 Milvexian。我認為 OPDIVO 是另一個例子,而作為 BioNTech——當我們將 327 推向市場時,我們將能夠將資源從 OPDIVO 重新分配到該藥物上。因此,從策略上講,我們非常清楚在哪裡推動成長,並能夠將資源重新分配給這些成長機會。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

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

    偉大的。謝謝,大衛。請讓我們進入下一個問題。

  • Operator

    Operator

  • Carter Gould, Barclays.

    巴克萊銀行的卡特·古爾德。

  • Carter Gould - Analyst

    Carter Gould - Analyst

  • Hi. Good morning. Thanks for taking the question. A little bit of a change of pace here, but if you'll indulge me, I always appreciate your view on the policy side, Chris. IP is under attack across the industry from multiple sources, but most notably compounding. While Bristol is not directly impacted today, it's not unreasonable, if left unchecked, that Bristol could be impacted in the future. Does Bristol share this view? And are there efforts you've taken either independently with peers, pharma, or in consultation with the administration to more staunchly advocate defensive IP in the space?

    你好。早安.感謝您回答這個問題。這裡的節奏有點變化,但如果你願意放縱我的話,我總是很欣賞你在政策上的看法,克里斯。整個產業的智慧財產權都受到來自多方面的攻擊,但最明顯的是,這種攻擊呈現複合型態。雖然布里斯托目前沒有受到直接影響,但如果不加以控制,布里斯托未來可能會受到影響,這也並非不合理。布里斯托是否也持這種觀點?您是否與同行、製藥公司獨立合作或與政府協商,以更堅定地倡導該領域的防禦性智慧財產權?

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks, Carter, and I appreciate the change of pace. I'm always happy to talk policy.

    謝謝,卡特,我很欣賞這種節奏的變化。我總是很樂意談論政策。

  • So I think one of the things that we've consistently said about the policy environment we operate in is that it's an ecosystem. It's an ecosystem that has multiple parts and components. And obviously, we spend a lot of time talking about changes at FDA and NIH and potentially the impact of policy proposals like MFN. But I think the point you're raising is one that's critically important is underpinning all of this ecosystem is intellectual property and the protection of intellectual property.

    因此,我認為,我們一直在談論我們所處的政策環境,它是一個生態系統。它是一個包含多個部分和組件的生態系統。顯然,我們花了很多時間討論 FDA 和 NIH 的變化以及 MFN 等政策提案可能產生的影響。但我認為您提出的觀點至關重要,即支撐整個生態系統的是智慧財產權和智慧財產權保護。

  • What I would say is, generally speaking, we've continued to see a lot of pressure on IP coming from multiple fronts. Internationally, that's been the case. We've seen it in the example that you cited. There are obviously differences with perspective on IP coming from different sectors of the economy. The nice thing that we have done as a company is we've got a very strong IP team. The leadership of that IP team at the company has, in turn, become leaders of IP for the industry. And so we feel that as a company, we've been front and center in helping to shape a positive environment around IP.

    我想說的是,總體而言,我們持續看到智慧財產權面臨來自多方面的巨大壓力。從國際上看,情況確實如此。我們在您引用的例子中已經看到過它。不同經濟部門對智慧財產權的看法顯然存在差異。作為一家公司,我們做得最好的事情就是擁有一支非常強大的智慧財產權團隊。該公司知識產權團隊的領導層反過來也成為了行業知識產權的領導者。因此,我們認為,作為一家公司,我們一直致力於幫助塑造積極的智慧財產權環境。

  • There are a lot of efforts across both bio and pharma to continue to maintain a strong IP environment. But IP is one of those things that you never take your eye off of a ball on, just given it is so central to the ecosystem that we have and underpins really the success that we've had as a country in leading in the biopharmaceutical space. So it's a great question and something that we continue to stay focused on.

    生物和製藥行業都做出了許多努力來繼續維持強大的智慧財產權環境。但智慧財產權是那些你永遠不會忽視的事情之一,因為它對於我們擁有的生態系統至關重要,並且真正支撐著我們作為一個國家在生物製藥領域的成功。這是一個很好的問題,我們會繼續關注它。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Great. Thanks, Chris. Next question, please.

    偉大的。謝謝,克里斯。請回答下一個問題。

  • Operator

    Operator

  • Akash Tewari, Jefferies.

    Akash Tewari,傑富瑞。

  • Akash Tewari - Analyst

    Akash Tewari - Analyst

  • Hey. Thanks so much. So for COBENFY and the EMERGENT schizophrenia trial, you had about 80% of patients get to the high dose. Given there's a clear issue with dropouts in the original xanomeline study and there's a clear dose response, what percentage of patients do you think for your upcoming AD psychosis study get to that 150 or 200 mg dose? What dropout rate have you powered for for this upcoming study?

    嘿。非常感謝。因此,對於 COBENFY 和 EMERGENT 精神分裂症試驗,大約 80% 的患者服用高劑量。鑑於原始 xanomeline 研究中存在明顯的退出問題,並且存在明顯的劑量反應,您認為在即將進行的 AD 精神病研究中,有多少比例的患者會達到 150 或 200 毫克的劑量?對於這項即將進行的研究,您預計的退出率是多少?

  • And then maybe stepping back, is Bristol still as bullish on the probability of success in the study as when the original Karuna deal was announced? And was there something about site conduct in the adjunct trial that made you concerned about it for the upcoming AD psychosis study? Thank you.

    然後也許退一步來看,布里斯托爾是否仍然像最初宣布卡魯納交易時一樣對這項研究的成功機率充滿信心?附加試驗中的現場行為是否存在一些問題讓您對即將進行的 AD 精神病研究感到擔憂?謝謝。

  • Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

    Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

  • I'll start off. And there's a lot of questions in there. I'll try and address as much as I can.

    我先開始了。這裡面有很多問題。我會盡力解決盡可能多的問題。

  • Keeping in mind, we are at a place where we are totally blinded to the data, so cannot comment on the specificities. As you know, the trial is designed with four dose escalations on week one, two, three, and four. Of course, the fourth one, the 200 milligram of COBENFY or KarXT with 20 of trospium is an optionality, but of course dependent on the tolerability.

    請記住,我們對數據完全視而不見,因此無法對具體情況發表評論。如您所知,該試驗設計了第一週、第二週、第三週和第四週四次劑量遞增。當然,第四種,200毫克的COBENFY或KarXT與20毫克的曲司溴銨是可選的,但當然取決於耐受性。

  • Remember, there's a huge difference between AD psychosis trial that we are conducting versus the 30-year-ago xanomeline-only studies that was conducted because of the tolerability issue where patients did go off treatment much more and the number of completers was limited because of the toxicity. So I would not necessarily draw true conclusions directly from that trial. Also over there, when we talk about the impact on some of the endpoints, much attention was paid to the cognition endpoint, ADAS-Cog, where the analysis was conducted and the significance was seen only in the ADAS-Cog highest dose level.

    請記住,我們正在進行的 AD 精神病試驗與 30 年前進行的僅使用 xanomeline 的研究之間存在巨大差異,因為耐受性問題,患者確實更多地停止治療,並且由於毒性,完成治療的患者數量有限。因此,我不一定能直接從該試驗中得出正確的結論。同樣在那裡,當我們談論對某些終點的影響時,我們非常關注認知終點 ADAS-Cog,在那裡進行了分析,並且僅在 ADAS-Cog 最高劑量水平下觀察到顯著性。

  • For the psychosis-related symptomatology, we did see dose-dependent improvements, but of course the paired-wise analysis was not conducted. We did see hallucinations, delusions, aggression, suspiciousness, all of those endpoints quite meaningfully impacted. So overall, we are really looking forward to the data from ADEPT-2, and that will help us guide in terms of the future discussions around this once the data are available.

    對於精神病相關症狀,我們確實看到了劑量依賴性改善,但當然沒有進行配對分析。我們確實看到了幻覺、妄想、攻擊性、多疑,所有這些終點都受到了相當大的影響。所以總的來說,我們非常期待 ADEPT-2 的數據,一旦數據可用,這將有助於我們指導未來圍繞這一問題的討論。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • And what I would say just in general is just, to close out that, is that the company remains very excited about the potential for COBENFY in Alzheimer's disease psychosis, as well as the underlying science behind that indication.

    總而言之,我想說的是,公司對 COBENFY 在治療阿茲海默症精神病方面的潛力以及該適應症背後的科學原理感到非常興奮。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Great. Thanks, Chris and Samit. Next question, please.

    偉大的。謝謝,克里斯和薩米特。請回答下一個問題。

  • Operator

    Operator

  • James Shin, Deutsche Bank.

    德意志銀行的詹姆斯辛 (James Shin)。

  • James Shin - Research Analyst

    James Shin - Research Analyst

  • Good morning. Thank you for the question. One for Chris. Chris, you followed through with picking winners and calling losers from Bristol's pipeline. So once Cristian settled into his seat, what sort of changes can we expect from the early-stage pipeline or the business development strategy? And maybe should investors expect a shift in Bristol's trough? Thank you.

    早安.謝謝你的提問。一份給克里斯。克里斯,你從布里斯託的管道中挑選出了贏家並預測了輸家。那麼,一旦克里斯蒂安就位,我們可以期待早期通路或業務發展策略發生什麼樣的變化?投資人或許應該預期布里斯託的低潮將會發生轉變?謝謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question. I think that we're doing everything we can as a management team today to do two things: one is shorten the time period that we're in a trough and make sure that we're driving sales as quickly as possible so that we can exit the decade with the strongest growth profile that we can. And you see that across the board, both with respect to the strength of the business and our existing growth portfolio, the fact that we've got a robust pipeline of mid to late-stage assets that can continue to progress nicely, and the fact that we're continuing to be very disciplined so that we have the financial flexibility to where it makes sense for the company to continue to source innovation externally.

    謝謝你的提問。我認為,作為管理團隊,我們正在盡一切努力做兩件事:一是縮短我們處於低谷的時間,並確保我們盡快推動銷售,以便我們能夠以最強勁的成長態勢度過這個十年。您可以從各個方面看到,無論是業務實力還是我們現有的成長組合,我們都擁有強大的中後期資產管道,可以繼續順利發展,而且我們將繼續保持高度自律,從而擁有財務靈活性,使公司能夠繼續從外部尋求創新。

  • With respect to the impact that Cristian will bring, I think in many respects, not just with respect to the early pipeline, but really across drug development, there's going to be a focus that we have on execution. As we've talked about, our pipeline and delivering on that pipeline is very important. And so we have to be acutely focused on strong execution. Cristian has a very strong background in that respect across his career, particularly with respect to his last company. Also, when you think about executing at scale, ensuring that you have the strongest, highest-performing teams with the best people that you can find is going to be important. And again, he has a very strong track record there.

    關於克里斯蒂安將帶來的影響,我認為在很多方面,不僅僅是在早期研發管線方面,而是在整個藥物開發過程中,我們都會把重點放在執行上。正如我們所討論的,我們的管道以及管道的交付非常重要。因此,我們必須高度重視強而有力的執行。克里斯蒂安在他的整個職業生涯中,尤其是在他上一家公司,在這方面有著非常強大的背景。此外,當您考慮大規模執行時,確保您擁有最強大、表現最好的團隊和您能找到的最優秀的人才將非常重要。而且,他在那裡有著非常出色的業績記錄。

  • The last two things I would say that we expect him to bring to the table are, first, a continuation of some of the work that Samit and his team have already started. Samit's really led an effort to rethink how we're thinking about drug development, everything from where and how we have our teams working to the employment of AI and technology. And we need to see that work continue and, in some places, accelerate.

    我想說的是,我們希望他能提出的最後兩件事是:首先,繼續薩米特和他的團隊已經開始的一些工作。薩米特確實引領了一場重新思考我們如何看待藥物開發的努力,從我們的團隊在哪裡以及如何工作到人工智慧和技術的使用。我們需要看到這項工作繼續下去,並且在某些地方加速前進。

  • And then the last thing I would say is, anytime you bring somebody in from outside the company, you would expect that they would bring a different approach, a different level of energy, a different way of thinking. And so I think there's an opportunity for a refresh there as well. But overall, Samit's team has put together a very nice foundation that Cristian will benefit from, and we look forward to seeing him join the company starting tomorrow.

    最後我想說的是,每當你從公司外部引進人才時,你會期望他們會帶來不同的方法、不同的活力和不同的思考方式。所以我認為這裡也有一個更新的機會。但總的來說,薩米特的團隊已經建立了一個非常好的基礎,克里斯蒂安將從中受益,我們期待他從明天開始加入公司。

  • Chuck Triano - Senior Vice President and Head of Investor Relations

    Chuck Triano - Senior Vice President and Head of Investor Relations

  • Thanks, Chris. We know you all have a busy day with other companies reporting and other calls. So operator, if we could take our last question, please.

    謝謝,克里斯。我們知道你們今天都很忙,要跟其他公司報告,還要打電話。接線員,請問我們可以回答最後一個問題嗎?

  • Operator

    Operator

  • Stephen Scala, TD Cowen.

    史蒂芬‧斯卡拉 (Stephen Scala),TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Hello. Thank you so much. On the Q1 call, Bristol said that they were exploring a path forward for COBENFY ARISE data, but that they needed to review all the data and talk with regulators. I'm wondering, has this additional analysis occurred and have the discussions already taken place? And if so, is there a path forward?

    你好。太感謝了。在第一季電話會議上,布里斯托表示,他們正在探索 COBENFY ARISE 數據的未來發展道路,但他們需要審查所有數據並與監管機構進行溝通。我想知道,是否已經進行了額外的分析並進行了討論?如果是這樣,還有前進的道路嗎?

  • And then secondly, on Sotyktu, can you clarify whether it's been filed in psoriatic arthritis? And what is your level of confidence and success for lupus and Sjögren's? Thank you.

    其次,關於 Sotyktu,您能否澄清它是否已在銀屑病關節炎領域提出申請?您對治療狼瘡和乾燥症的信心和成功率如何?謝謝。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • Thanks for the question, Steve. I'll ask Samit to take over those.

    謝謝你的提問,史蒂夫。我會讓薩米特 (Samit) 接管這些。

  • Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

    Samit Hirawat - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team

  • Yeah. So thank you, Steve. Always great questions from you.

    是的。所以謝謝你,史蒂夫。您總是會問出很棒的問題。

  • For ARISE, no conversations have occurred from the health authority perspective. We are continuing to look deeper into the data, also understand the distribution of patients to the various cohorts within the study. So certainly, when and as new data become available from an analysis perspective, we will be able to share it in the future conferences and future conversations as well.

    對於 ARISE,從衛生當局的角度來看尚未發生任何對話。我們正在繼續深入研究數據,並了解研究中各個群體中患者的分佈。因此,當然,當從分析角度獲得新數據時,我們也能夠在未來的會議和對話中分享它。

  • For Sotyktu, certainly very happy that the submissions have occurred for psoriatic arthritis, looking forward to those engagements and see that to fruition. For SLE, remember what the data -- the Phase 3 trials were based on the outcomes of the Phase 2 study that was very well conducted. And we have learned from those studies that this heterogeneous population, hands-on data cleaning, as well as data activities, are very important. So we are very carefully continuing to clean the data in real time as we continue to enroll the patients.

    對於 Sotyktu 來說,當然非常高興能夠收到有關銀屑病關節炎的申請,期待這些合作並看到其成果。對於 SLE,請記住數據-第 3 階段試驗是基於第 2 階段研究的結果,而第 2 階段研究進行得非常好。我們從這些研究中了解到,這個異質群體、實際資料清理以及資料活動都非常重要。因此,我們在繼續招募患者的同時,會非常小心地即時清理資料。

  • And then, of course, Sjögren's is the other one. The good news is these studies are enrolling really well, and we look forward to the readouts towards the back end of next year onwards.

    當然,乾燥症是另一種。好消息是這些研究的參與情況非常好,我們期待明年年底及以後的結果。

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

    Christopher Boerner - Chairman of the Board, Chief Executive Officer

  • So thanks, everyone. As Chuck mentioned, we know it's a very busy morning, so we want to thank you all for joining. And as always, the team will be available.

    謝謝大家。正如查克所提到的,我們知道今天早上非常忙碌,所以我們要感謝大家的加入。和往常一樣,我們的團隊將隨時為您服務。

  • Let me just say in closing that we continue to make very good progress reshaping the company for long-term growth. Importantly, hopefully you're seeing that we're driving execution really across the business, and that's yielding the results that we saw in the quarter. Second half is going to be a very busy time at the company, but we feel very good about the momentum coming into the second half of the year.

    最後,我想說的是,我們在重塑公司以實現長期成長方面繼續取得非常好的進展。重要的是,希望您看到我們正在真正推動整個業務的執行,並且正在產生我們在本季度看到的成果。下半年將是公司非常忙碌的時期,但我們對下半年的發展動能感到非常樂觀。

  • And then again, before I sign off, I just want to again say a big thank you to Samit for all of the contributions and the leadership that he's had at the company over the last six years.

    然後,在我結束演講之前,我只想再次對薩米特在過去六年為公司所做的貢獻和發揮的領導作用表示衷心的感謝。

  • And with that, I wish you all a good rest of the day and rest of the week. And as always, reach out if you have questions. Thanks.

    最後,我祝福大家今天和本週剩餘時間過得愉快。像往常一樣,如果您有任何問題,請與我們聯繫。謝謝。

  • Operator

    Operator

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

    會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。