施貴寶 (BMY) 2026 Q1 法說會逐字稿

Welcome to the Bristol-Myers Squibb first quarter 2026 earnings conference call. (Operator Instructions) Please note this event is being recorded.

歡迎參加百時美施貴寶（Bristol-Myers Squibb）2026 年第一季財報電話會議。（接線員指示）請注意，本活動將被錄音。

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

我現在想將會議交給投資人關係資深副總裁暨主管 Chuck Triano。請開始。

Thank you, and good morning, everyone. We appreciate you joining our first quarter 2026 earnings call. With me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer; and David Elkins, our Chief Financial Officer. Also participating in today's call is Adam Lenkowsky, our Chief Commercialization Officer; and Cristian Massacesi, our Chief Medical Officer and Head of Global Drug Development.

謝謝，各位早安。感謝各位參加我們 2026 年第一季財報電話會議。今天早上與我一同進行事先準備發言的有：董事會主席暨執行長 Chris Boerner，以及財務長 David Elkins。另有參與今天電話會議的還包括：商業化長 Adam Lenkowsky，以及醫務長暨全球藥物開發主管 Cristian Massacesi。

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.

今天稍早，我們已將本季簡報投影片發布於 bms.com，您可用以配合 Chris 與 David 的發言內容。

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.

在開始之前，我要提醒各位，本次電話會議中我們將就公司未來計畫與前景發表聲明，這些聲明構成前瞻性陳述。由於多項重要因素，實際結果可能與這些前瞻性陳述所示有重大差異，其中包括公司向 SEC 提交之文件中所討論的因素。這些前瞻性陳述代表我們截至今日的估計，不應被依賴為代表任何未來日期的估計；即使我們的估計有所變動，我們亦明確聲明不負更新前瞻性陳述之任何義務。

We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliation of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com. Finally, unless otherwise stated, all comparisons are made from the same period in 2025, 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.

我們也將把評論重點放在非 GAAP 財務衡量指標上，該等指標已調整以排除特定項目。部分非 GAAP 財務衡量指標與最可比 GAAP 指標之調節表可於 bms.com 查閱。最後，除非另有說明，所有比較均以 2025 年同期為基準；銷售成長率將以「基礎」口徑討論，即排除外匯影響。所有損益表（P&L）相關引用均以非 GAAP 口徑呈現。

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

那麼，我把時間交給 Chris。

Thanks, Chuck. Welcome, and thank you for joining our first-quarter earnings call. We delivered a solid Q1 and continue to improve our say-to-do ratio with disciplined execution across the business as we continue to best position the company for long-term sustainable growth.

謝謝，Chuck。歡迎各位，也感謝各位參加我們第一季財報電話會議。我們第一季表現穩健，並在全公司以紀律化執行持續提升「說到做到」的比率，同時持續讓公司處於最有利位置，以實現長期且可持續的成長。

Our strategy remains grounded in three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio, and maintaining disciplined shareholder-friendly capital allocation. We saw progress across all three in the quarter.

我們的策略仍以三大優先事項為核心：將研發聚焦於威脅生命的疾病、推動全組織強而有力的執行以在成長產品組合中建立動能，以及維持有紀律且對股東友善的資本配置。本季我們在三方面皆取得進展。

Let me start by highlighting our performance on slide 4. We started off the year with solid results across our key marketed products. In the quarter, growth portfolio sales were up 9% year over year with contributions from a broad range of assets, including Reblozyl, Breyanzi, Camzyos, Opdualag, Qvantig, and Cobenfy. These are differentiated, durable assets that treat serious diseases and remain early in their life cycles, and they continue to strengthen our foundation for long-term growth.

我先從投影片第 4 頁的表現重點談起。我們以關鍵上市產品的穩健表現展開新的一年。本季，成長產品組合銷售額年增 9%，貢獻來自多項資產，包括 Reblozyl、Breyanzi、Camzyos、Opdualag、Qvantig 與 Cobenfy。這些是具差異化、具持久性的資產，用於治療嚴重疾病，且仍處於產品生命週期的早期階段，持續強化我們長期成長的基礎。

Overall, our growth portfolio performed in line with our expectations for this quarter. Outside of the growth portfolio, Eliquis performed well and grew in line with the range we provided on our Q4 call. David will provide more details on the financials shortly.

整體而言，我們的成長產品組合表現符合本季預期。成長產品組合以外，Eliquis 表現良好，成長幅度亦符合我們在第四季電話會議所提供的區間。David 稍後將就財務細節提供更多說明。

Turning to our recent regulatory and clinical milestones. In Q1, we made progress advancing our broad and diversified pipeline. Regarding our CELMoDs, iberdomide and mezigdomide, our iberdomide filing for relapsed or refractory multiple myeloma was accepted by the FDA with breakthrough therapy designation and priority review with a PDUFA date of August 17. This is an important step for our protein degradation platform, potentially enabling us to bring the first CELMoD to market.

接著談近期法規與臨床里程碑。第一季，我們在推進廣泛且多元的產品線方面取得進展。就我們的 CELMoDs（iberdomide 與 mezigdomide）而言，我們針對復發或難治性多發性骨髓瘤的 iberdomide 申請已獲 FDA 受理，並取得突破性療法認定與優先審查，PDUFA 日期為 8 月 17 日。這是我們蛋白降解平台的重要一步，可能使我們得以將首個 CELMoD 推向市場。

For mezigdomide, we reported positive Phase III interim data from the SUCCESSOR-2 study, demonstrating a meaningful improvement in progression-free survival in patients with relapsed or refractory multiple myeloma. This marks the second positive pivotal readout from our oral CELMoD program and further strengthens our conviction in the platform.

至於 mezigdomide，我們公布 SUCCESSOR-2 研究的第三期期中正向數據，顯示在復發或難治性多發性骨髓瘤患者中，無惡化存活期（PFS）有具意義的改善。這是我們口服 CELMoD 計畫第二項正向關鍵性試驗讀出，並進一步強化我們對該平台的信心。

We will also present the full data at ASCO and are actively planning regulatory submissions based upon the data. For our ADC Iza-bren, we shared positive Phase III interim top-line results in patients with previously treated triple-negative breast cancer based on a study conducted in China. We will present these exciting data along with the positive Phase III China study results for Iza-bren in previously treated esophageal squamous cell carcinoma at ASCO.

我們也將在 ASCO 發表完整數據，並正基於該等數據積極規劃法規申請。就我們的 ADC Iza-bren 而言，我們分享了在既往治療過的三陰性乳癌患者中之第三期期中正向主要結果，該結果基於一項在中國進行的研究。我們將在 ASCO 發表這些令人振奮的數據，並同時發表 Iza-bren 於既往治療過的食道鱗狀細胞癌之第三期中國研究正向結果。

At the same time, we continue to broaden the reach of our in-market portfolio through life cycle expansion. We received approvals for Sotyktu in psoriatic arthritis and Opdivo for two new classical Hodgkin Lymphoma indications. We also reported positive Phase IV switch data for Cobenfy, positive Phase III data for Camzyos in adolescents with obstructive HCM, and positive Phase II data for Reblozyl in Alpha Thalassemia. Stepping back, these updates reflect the diversity and breadth of our pipeline, both in terms of therapeutic areas and modalities as well as continued execution across the business.

同時，我們持續透過生命週期擴展來拓展已上市產品組合的觸及範圍。我們取得 Sotyktu 於乾癬性關節炎的核准，以及 Opdivo 於兩項新的經典型霍奇金淋巴瘤適應症的核准。我們也公布 Cobenfy 的第四期轉換（switch）正向數據、Camzyos 於阻塞型肥厚性心肌病（HCM）青少年族群的第三期正向數據，以及 Reblozyl 於 α 地中海型貧血（Alpha Thalassemia）的第二期正向數據。整體而言，這些更新反映了我們產品線在治療領域與技術平台（modalities）上的多樣性與廣度，以及我們在全公司持續的執行力。

Moving to slide 5. As we've said, the latter part of 2026 is shaping up to include an increasing cadence of pivotal readouts that are expected to further define and derisk our long-term growth profile. Among the Phase III readouts expected late in the year are milvexian in atrial fibrillation and secondary stroke prevention, Cobenfy in Alzheimer's psychosis, admilparant in IPF, and iberdomide PFS data. We anticipate these readouts will help us further diversify and broaden our portfolio and are part of our efforts to deliver more than 10 new medicines and 30 meaningful life cycle management opportunities by the end of the decade.

接著看投影片第 5 頁。如同我們所說，2026 年下半年正逐步形成更密集的關鍵性試驗讀出節奏，預期將進一步界定並降低我們長期成長輪廓的風險。預計於年底前後公布的第三期讀出包括：milvexian 用於心房顫動與次級中風預防、Cobenfy 用於阿茲海默症精神病、admilparant 用於特發性肺纖維化（IPF），以及 iberdomide 的 PFS 數據。我們預期這些讀出將協助我們進一步多元化並拓展產品組合，亦是我們致力於在本十年末前交付超過 10 款新藥與 30 項具意義的生命週期管理機會的一部分。

Turning to slide 6. Central to delivering on these opportunities and enabling sustained long-term growth are our efforts to drive top-tier R&D productivity. In our development organization, we continue to improve execution across drug development by upgrading talent, streamlining decision-making, and instituting tighter management of core clinical activities. We are also focused on enhancing the quality and depth of our early to mid-stage pipeline. Underpinning these efforts are investments we are making in core R&D infrastructure, including broadening the use of AI tools together with laboratory automation and people trained in the right ways of working.

接著看投影片第 6 頁。要實現這些機會並支撐長期可持續成長，我們推動頂尖研發生產力的努力至關重要。在開發組織方面，我們持續透過升級人才、精簡決策流程，以及對核心臨床活動導入更嚴謹的管理，來提升藥物開發的執行力。我們也聚焦於提升早期至中期產品線的品質與深度。支撐這些努力的是我們對核心研發基礎設施的投資，包括擴大 AI 工具的使用、結合實驗室自動化，以及培養具備正確工作方式的人才。

In research and early development, target selection and molecule design can have an outsized impact on long-term value. We have set a target to reach lead molecule identification approximately 50% faster while applying greater rigor so that only the most differentiated molecules advance.

在研究與早期開發階段，標的選擇與分子設計可能對長期價值產生不成比例的影響。我們已設定目標：在更高標準的嚴謹性下，將先導分子（lead molecule）辨識速度提升約 50%，以確保只有最具差異化的分子得以推進。

In late development, we're using AI to streamline clinical operations, compress development timelines, and enhance quality oversight. Over time, we expect these efforts to deliver a 30% reduction in cycle times versus just a few years ago.

在後期開發方面，我們正運用 AI 來精簡臨床營運、壓縮開發時程，並強化品質監督。隨時間推進，我們預期這些努力可使週期時間相較於數年前降低 30%。

Among others, we have ongoing partnerships with Faro, enabling us to design trials more efficiently and Evinova's Cost Optimizer tool. These ongoing efforts across R&D are top priorities for 2026. The organization's continued focus on financial discipline enables us to make these and other important investments. We remain on track to deliver the remainder of our $2 billion in cost savings from our strategic productivity initiative by the end of 2027.

此外，我們與 Faro 等夥伴維持合作，使我們能更有效率地設計試驗，並使用 Evinova 的 Cost Optimizer 工具。這些研發面向的持續推進是 2026 年的最優先事項。組織對財務紀律的持續聚焦，使我們得以進行這些及其他重要投資。我們仍按計畫在 2027 年底前，完成策略性生產力計畫剩餘的 20 億美元成本節省目標。

With respect to capital allocation, business development remains an important focus. As always, we will continue to index on opportunities where we add strategic value and where we can deliver attractive returns. As our post-LOE growth profile becomes clearer, we'll naturally place greater emphasis on expanding our early and mid-stage portfolio to support growth into the 2030s.

在資本配置方面，業務開發仍是重要重點。一如既往，我們將持續聚焦於我們能夠增加策略價值、並可帶來具吸引力報酬的機會。隨著我們在專利到期（LOE）後的成長輪廓愈加清晰，我們自然會更著重於擴充早期與中期產品組合，以支撐 2030 年代的成長。

In summary, based on our performance, we see the business currently tracking towards the upper end of our guidance ranges. Looking forward, we have continued momentum in our growth portfolio, broad potential in our pipeline, and the ability to invest in our business while becoming more focused and efficient in how we operate.

總結而言，基於我們的表現，我們認為目前業務進展正朝向我們財測區間的上緣。展望未來，我們的成長產品組合動能持續、產品線具廣泛潛力，並且在營運更聚焦、更有效率的同時，仍有能力投資於業務。

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

那麼，我把時間交給 David。

Thank you, Chris, and good morning, everyone. Our performance in 2026 is off to a strong start as highlighted by our first-quarter results. We delivered solid R&D, commercial, and financial performance while continuing to manage our cost structure. Our persistent focus on execution has further strengthened our foundation as we position the company for long-term sustainable growth. I will begin with a review of our first quarter results and then discuss our financial outlook for the remainder of the year.

謝謝你，Chris，各位早安。我們在 2026 年的表現有一個強勁的開局，第一季的結果已凸顯這一點。我們在持續管理成本結構的同時，交出了穩健的研發、商業與財務表現。我們對執行力的持續專注，進一步強化了我們的基礎，並使公司得以為長期、可持續的成長做好定位。我將先回顧第一季的業績，接著討論今年剩餘期間的財務展望。

Starting with slide 8. Total revenue in the first quarter was up 1% year over year at approximately $11.5 billion. Our growth portfolio continued to perform well with global revenue increasing 9% to $6.2 billion. As Chris mentioned, several products that are still early in their life cycles are driving growth as we intentionally expand our business across a wider range of key assets. Within the legacy portfolio, we saw solid growth from Eliquis, which was offset by the continued impact of increased generic entry across several other brands.

從第 8 張投影片開始。第一季總營收年增 1%，約為 115 億美元。我們的成長產品組合持續表現良好，全球營收成長 9% 至 62 億美元。如 Chris 所提到，數個仍處於產品生命週期早期的產品正在帶動成長，因為我們有意將業務擴展至更廣泛的關鍵資產範圍。在既有產品組合方面，我們看到 Eliquis 有穩健成長，但被其他數個品牌因學名藥進入增加所帶來的持續影響所抵銷。

All in, we are very pleased with our results in the quarter as we build upon our objective to reshape and redefine BMS as one of the fastest-growing pharmaceutical companies into the next decade.

整體而言，我們對本季的結果非常滿意，因為我們正持續推進目標：在未來十年把 BMS 重塑並重新定義為成長最快的製藥公司之一。

Turning to product performance on slide 9, starting with oncology. Opdivo revenue decreased 8% to approximately $2.1 billion, with most of this decline coming from the US. This was primarily driven by an Opdivo inventory drawdown at the wholesaler level, where inventories are at the low end of the typical range. We continue to monitor whether these levels will normalize over the balance of the year.

接著看第 9 張投影片的產品表現，先從腫瘤領域開始。Opdivo 營收下降 8% 至約 21 億美元，其中大部分下滑來自美國。主要原因是批發商層級的 Opdivo 庫存去化，目前庫存位於典型區間的低端。我們將持續觀察這些水位是否會在今年剩餘期間回歸常態。

In addition, we saw continued conversion to Qvantig, where the launch continues to progress well with revenues of $163 million. With Opdualag, we delivered another quarter of strong double-digit growth driven by demand globally, where it remains a standard of care in first-line melanoma.

此外，我們也看到持續轉換至 Qvantig；其上市進展仍然良好，營收為 1.63 億美元。至於 Opdualag，我們再度交出一季強勁的雙位數成長，主要由全球需求帶動；在一線黑色素瘤治療中，它仍是標準治療。

Turning to slide 10. Reblozyl delivered 15% growth with performance continuing to reflect solid uptake across first- and second-line MDS-associated anemia. In cell therapy, Breyanzi's first quarter growth of 53% reflects its best-in-class profile and continued strong demand across its approved indications in both the US and international markets. We remain encouraged by Breyanzi's continued momentum and growth prospects.

接著看第 10 張投影片。Reblozyl 成長 15%，表現持續反映其在第一線與第二線 MDS 相關貧血的穩健採用。在細胞治療方面，Breyanzi 第一季成長 53%，反映其同級最佳（best-in-class）的特性，以及在美國與國際市場各已核准適應症上的持續強勁需求。我們對 Breyanzi 持續的動能與成長前景仍感到鼓舞。

Moving to Cardiovascular and Immunology on slide 11. Eliquis revenue was approximately $4.1 billion in the quarter, an increase of 13%. We continue to see strong demand. And given our US price reduction that took effect at the beginning of the year, we also saw some wholesaler inventory build in the first quarter. We anticipate this build to reverse in the second quarter.

接著看第 11 張投影片的心血管與免疫領域。Eliquis 本季營收約 41 億美元，成長 13%。我們持續看到強勁需求。且由於我們在年初生效的美國降價措施，第一季也出現一些批發商庫存回補。我們預期這項回補將在第二季反轉。

Turning to Camzyos. Revenue in the first quarter nearly doubled to $314 million, benefiting from continued demand growth globally. Now moving to immunology. Global revenue of Sotyktu grew 20%. The recent approval in psoriatic arthritis represents a continued presence in rheumatology while we await our Phase III readouts in Lupus and Sjogren’'s disease.

接著談 Camzyos。第一季營收幾乎倍增至 3.14 億美元，受惠於全球需求持續成長。現在轉到免疫領域。Sotyktu 全球營收成長 20%。近期在乾癬性關節炎的核准，代表我們在風濕免疫領域的持續布局，同時我們也在等待紅斑性狼瘡與修格蘭氏症（Sjogren’'s disease）的第三期試驗讀出。

I will wrap up our product performance on slide 12 with neuroscience, where Cobenfy revenue in the first quarter was $56 million, representing continued steady growth.

我將以第 12 張投影片的神經科學作為產品表現的總結：Cobenfy 第一季營收為 5,600 萬美元，代表持續穩定成長。

Now let's move to the P&L on slide 13. As expected, gross margin declined 280 basis points in the first quarter to 70.3%, which was primarily driven by product mix. Excluding in-process R&D, operating expenses for the first quarter were $3.9 billion, slightly above the same period last year. As compared to a year ago, the incremental investment related to Pumitamig, Qvantig, and Cobenfy was largely offset by savings from our strategic productivity initiative. This continues to provide additional flexibility to invest behind these growth-oriented opportunities.

現在我們看第 13 張投影片的損益表。如預期，第一季毛利率下降 280 個基點至 70.3%，主要由產品組合所驅動。排除在研研發（in-process R&D）後，第一季營業費用為 39 億美元，略高於去年同期。相較一年前，與 Pumitamig、Qvantig 與 Cobenfy 相關的增量投資，大致被我們策略性生產力計畫所帶來的節省所抵銷。這也持續提供額外彈性，使我們能加大投資於這些以成長為導向的機會。

Our effective tax rate in the quarter was 18.3%, reflecting jurisdictional earnings mix. Overall, diluted earnings per share was $1.58 for the quarter, which includes a net charge of $0.03 a share related to in-process R&D and licensing income.

本季有效稅率為 18.3%，反映各司法管轄區的獲利組合。整體而言，本季稀釋後每股盈餘為 1.58 美元，其中包含與在研研發及授權收入相關、每股 0.03 美元的淨費用。

Turning to the balance sheet and capital allocation highlights on slide 14. Our financial position remains strong with approximately $11 billion in cash equivalents and marketable securities as of March 31. In the first quarter, we generated approximately $1.1 billion in operating cash flow. This quarter's cash flow reflects roughly $1.2 billion and lower net cash collections due to Eliquis list price reductions. We expect this to be more than offset later in the year through lower rebate payments.

接著看第 14 張投影片的資產負債表與資本配置重點。截至 3 月 31 日，我們的財務狀況仍然強勁，約有 110 億美元的約當現金與有價證券。第一季我們產生約 11 億美元的營運現金流。本季現金流反映約 12 億美元，以及因 Eliquis 定價下調而導致的淨現金回收較低。我們預期今年稍晚將透過較低的回扣支付而使其獲得超額抵銷。

In terms of capital allocation, we continue to take strategic and a balanced approach to deploying our strong cash flows. Business development remains a priority, and we are regularly evaluating opportunities in the therapeutic areas we know best while continuing to return cash to shareholders through our commitment to the dividend.

在資本配置方面，我們持續以策略性且均衡的方式運用強勁的現金流。業務開發（BD）仍是優先事項，我們會定期評估我們最熟悉的治療領域中的機會，同時也透過對股利的承諾持續回饋股東。

Now moving to guidance on slide 15. We are reaffirming our financial guidance for the full year of 2026. Based upon the first quarter results and our current projections, we see our financial performance tracking towards the upper end of our established revenue and EPS guidance ranges. We will continue to provide updates as the year progresses.

現在看第 15 張投影片的財測指引。我們重申 2026 全年的財務指引。根據第一季結果與目前預測，我們的財務表現正朝向既定營收與 EPS 指引區間的上緣推進。我們將在年度進行期間持續提供更新。

In closing, our strong performance in the quarter reinforces our confidence in our ability to deliver long-term value for our patients and shareholders. And to reiterate Chris' comment, our strategy remains grounded in three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio, and maintaining disciplined shareholder-friendly capital allocation.

最後，本季的強勁表現強化了我們對自身能力的信心，能為病患與股東創造長期價值。並再次重申 Chris 的評論，我們的策略仍以三項優先事項為基礎：將研發聚焦於威脅生命的疾病、推動全組織的強力執行以在成長產品組合中建立動能，以及維持紀律且對股東友善的資本配置。

And with that, I'll now turn the call back over to Chuck for Q&A.

那麼，我現在把電話交回給 Chuck 進行問答。

(Operator Instructions) Asad Haider, Goldman Sachs.

（接線員指示）Asad Haider，高盛。

Great. Just maybe just to open, just given how consequential the clinical readouts at the end of this year are going to be for the company, Cristian, just starting with you, can you just level set us on your confidence in the key programs, specifically for milvexian AF and the Cobenfy ADEPT trials? Just any quantitative bars for success?

很好。先從一個開場問題：考量到今年年底的臨床讀出對公司將非常關鍵，Cristian，先從你開始，你能否幫我們校準一下你對關鍵計畫的信心，特別是 milvexian 的 AF 與 Cobenfy 的 ADEPT 試驗？是否有任何量化的成功門檻？

And then related for Chris, how do the timing of these readouts impact the company's BD strategy as you think about the different outcomes that could unfold with the results of each of these readouts? And where do you see opportunity as you scan the landscape ahead of these readouts? And any framing on potential size of the BD aperture would be helpful.

然後也相關地問 Chris：當你思考各項讀出結果可能帶來的不同情境時，這些讀出的時間點會如何影響公司的 BD 策略？在這些讀出之前，你在掃描市場版圖時看到了哪些機會？若能提供對 BD 可涵蓋範圍（aperture）潛在規模的框架也會很有幫助。

Thanks for the question, Asad. Cristian, do you want to start, and then I'll take the BD question.

謝謝你的問題，Asad。Cristian，你要先開始嗎？然後我再回答 BD 的問題。

Thank you, Asad, for the question. Let me start with the fact that we have a very data-rich 2026 and even probably more '27. And let me start with what we already achieved because in (inaudible), I think we had a positive MRD with iberdomide in EXCALIBER in '25, and we are expecting the PFS later this year. As Chris mentioned in his opening remarks, the PDUFA date for this filing is August 17. We got breakthrough designation, priority review. So it's progressing at pace.

謝謝你，Asad，提出這個問題。先說明一點：我們在 2026 年有非常多數據讀出，甚至 2027 年可能更多。先從我們已經達成的成果談起：在（聽不清）方面，我想我們在 2025 年 EXCALIBER 試驗中，iberdomide 的 MRD 結果為正向，而我們預期今年稍晚會有 PFS。正如 Chris 在開場致詞中提到，這項申請的 PDUFA 日期是 8 月 17 日。我們獲得突破性療法認定與優先審查，因此進度正按節奏推進。

We achieved mezigdomide this year with SUCCESSOR-2 oral presentation at ASCO, really looking forward to show you guys the data. In (inaudible), we will have a readout also with our Arlo-cel that is a GPRC5D CAR-T that is happening later this year.

今年我們也在 ASCO 以 SUCCESSOR-2 的口頭報告呈現 mezigdomide 的成果，非常期待向各位展示數據。在（聽不清）方面，我們也將在今年稍晚讀出 Arlo-cel 的結果；這是一個 GPRC5D CAR-T。

Moving cardiovascular, milvexian, as you was mentioning, are important readout. Both AFib and SSP are -- continue to be expected by the end of the year. We recruiting the events. It's an event-driven. Of course, we are mind blinded. We are recruiting the events as planned.

轉到心血管領域，你提到的 milvexian 是重要的讀出。AFib 與 SSP 兩項試驗仍預期在年底前讀出。我們正在累積事件；這是事件驅動的試驗。當然，我們仍維持盲態。我們正按計畫累積事件。

And we have the DMC that regularly is reviewing the data, and even in the most recent meeting, they're recommending to continue the studies as planned. So BMS will be the only Factor XI -- company with Factor XI inhibitor in AFib, of course, with the presence also in SSP, this can allow us to continue to lead in the thrombotic space. Confidence remains absolutely unchanged for milvexian in this space.

此外，我們有 DMC 定期審查數據，即使在最近一次會議中，他們也建議按計畫繼續研究。因此，BMS 將會是唯一一家在 AFib 擁有第 XI 因子（Factor XI）抑制劑的公司；當然，同時也布局於 SSP，這將使我們能持續在血栓領域保持領先。我們對 milvexian 在此領域的信心完全沒有改變。

In neuroscience, we continue to expect the ADP studies, ADEPT 1, 2, and 4 by -- readouts by the end of the year. This is based on very -- we are managing the studies and moving the studies more or less at the same -- with the same timelines. So they are lining up quite nicely. We need two studies probably for an approval. This is the base case, but for a filing, but we will see how the evolution in this space is happening.

在神經科學領域，我們仍預期 ADP 研究、ADEPT 1、2 與 4 將在今年年底前讀出結果。這是基於非常——我們正在管理這些研究，並以大致相同——相同的時程推進研究。因此它們的進度對齊得相當不錯。我們可能需要兩項研究才能獲得核准。這是基本情境（base case），也就是用於申報（filing），但我們將觀察此領域的演進情況。

The confidence remain unchanged also for Cobenfy study designs. Trial conduction is now completely under control. And of course, the reason to believe in Cobenfy in this space are very clear. Prior data, the data that we have seen in schizophrenia and of course, the open label in ADEPT-1, where patients before being randomized received Cobenfy for 12 weeks, give us confidence in potentially bringing this drug in patients with Alzheimer's disease and psychosis.

對於 Cobenfy 的研究設計，我們的信心也維持不變。試驗執行目前已完全在掌控之中。當然，我們之所以相信 Cobenfy 在此領域的理由非常清楚：既有數據、我們在思覺失調症中看到的數據，以及 ADEPT-1 的開放標籤（open label）資料——患者在隨機分派前先接受 Cobenfy 治療 12 週——都讓我們有信心，這項藥物有潛力用於阿茲海默症合併精神病症狀的患者。

Last but not least, to me, critical readout this year is admilparant in immunology, in IPF and PPF -- this is a novel mechanism, LPA1. This is an inhibitor that can bring a novel mechanism to patients with this very, very difficult to treat disease. It's a first-in-class asset with a very differentiated profile, not only on the efficacy side, but also on the safety side. IPF is guided by the end of the year, PPF will be just a few months later, probably beginning '27. Very solid Phase II data.

最後但同樣重要的是，就我而言，今年關鍵的讀出結果是免疫學領域的 admilparant，在 IPF 與 PPF——這是一種新穎機制，LPA1。這是一種抑制劑，能為這種非常、非常難以治療的疾病患者帶來新的作用機制。它是同類首創（first-in-class）的資產，具備高度差異化的特徵，不僅在療效面，也在安全性面。IPF 的讀出時間指引為今年年底，PPF 則會晚幾個月，可能在 2027 年初。第二期（Phase II）數據非常扎實。

I'm very pleased on the execution of the Phase III programs. So this is another important therapeutic option. As Chris mentioned, there is much more this year, next year, I have to say, it's an exciting time to be BMS.

我對第三期（Phase III）計畫的執行非常滿意。因此這是另一個重要的治療選項。正如 Chris 提到的，今年、明年還有更多進展；我必須說，現在是成為 BMS 的令人振奮的時刻。

Thanks, Cristian. And then Asad, just on your BD question. Look, BD continues to be a top capital allocation priority for us. It's not impacted by the end of year readouts. We have a very strong late-stage pipeline.

謝謝你，Cristian。接著 Asad，關於你對 BD 的問題。你看，BD 仍然是我們資本配置的首要優先事項之一。它不會受到年底讀出結果的影響。我們擁有非常強勁的後期（late-stage）研發管線。

We certainly don't need to chase deals. But as we've said consistently, if there are opportunities that make sense for us to enhance near-term growth, we have the financial flexibility to be in the mix. At the same time, we're building for the long term, and we're going to continue to add to our early and mid-stage pipeline as well.

我們當然不需要追逐交易。但正如我們一貫所說，如果有機會能合理地強化我們的近期成長，我們具備財務彈性可以參與其中。同時，我們也在為長期布局，並將持續充實我們的早期與中期研發管線。

And of course, given the size of those deals, we can certainly do both. Irrespective of phase of development, though, the opportunities we're looking for in areas we know well scientifically, where we can add clinical and commercial value and ultimately, we can deliver value to patients and to our shareholders. We're size agnostic as we've been, and we certainly have the financial horsepower to go after multiple sized deals.

當然，考量到這些交易的規模，我們確實可以兩者兼顧。不過不論開發階段為何，我們尋找的機會都在我們科學上非常熟悉的領域，在那裡我們能增加臨床與商業價值，最終為患者與股東創造價值。我們一如既往對規模不設限（size agnostic），而且我們確實具備充足的財務火力去追求多種不同規模的交易。

Geoff Meacham, Citi.

Geoff Meacham，花旗（Citi）。

Cristian, on pumitamig, I wanted to check on the cadence of data in, say, the next 6 to 12 months? And would you wait for more mature data on PFS before you really expand the number of trials? Or are you ready to go right now? And then real quick on -- for Adam, just to talk through the Qvantig dynamics versus Opdivo and where you're seeing the biggest demand?

Cristian，關於 pumitamig，我想確認一下未來 6 到 12 個月的數據節奏（cadence）會是如何？在你真正擴大試驗數量之前，你會等待更成熟的 PFS 數據嗎？還是你們現在就準備好要推進？另外很快一題——給 Adam，請談談 Qvantig 相對於 Opdivo 的動態，以及你們看到需求最大的地方在哪裡？

Thanks, Geoff. Cristian and Adam.

謝謝你，Geoff。Cristian 和 Adam。

Thank you, Geoff, for the question on pumitamig. Let me start with ASCO. ASCO will be an important meeting this year for PD-1 VEGF inhibitors. There are some competitor data in plenary that, of course, increase the confidence in the class. And we are presenting as an oral, our Phase II data in non-small cell lung cancer in frontline as a global data set after the China data we presented previously in other indications. In a few days, the abstract will be released.

謝謝你，Geoff，關於 pumitamig 的問題。我先從 ASCO 談起。ASCO 將是今年 PD-1 VEGF 抑制劑的重要會議。會上有一些競品在全體會議（plenary）發表的數據，當然會提升我們對這一類別的信心。而我們將以口頭報告（oral）形式，發表我們在非小細胞肺癌一線治療的第二期（Phase II）數據，這是一個全球數據集，延續我們先前在其他適應症中發表的中國數據。再過幾天摘要（abstract）就會公布。

Our strategy with pumitamig is replace and expand. We want to replace PD-1, PD-L1 inhibitors, and we want to expand beyond them. We announced and we delivered seven pivotal studies across indications. All of them are ongoing and all of them are recruiting actively. What is very important in my view is also what we are doing beyond the first wave of trials.

我們對 pumitamig 的策略是「替代並擴張」（replace and expand）。我們希望取代 PD-1、PD-L1 抑制劑，並在其基礎上進一步擴張。我們已宣布並推進了跨適應症的七項關鍵性（pivotal）研究。它們全部都在進行中，且都在積極招募。我認為非常重要的一點是，我們也在推進第一波試驗之外的工作。

The confidence, in my view, is becoming more and more tangible in terms of level of activity, a combinability that you have with PD-1, VEGF, PD-L1 VEGF inhibitors, bispecifics. And in my view, this is potentially translatable across indications. Now the next step, at least in our strategy is novel, novel combinations. And BMS has a very rich oncology portfolio.

在我看來，我們的信心正變得越來越具體，體現在活性水準以及與 PD-1、VEGF、PD-L1 VEGF 抑制劑、雙特異性抗體（bispecifics）的可聯合性（combinability）。而在我看來，這有可能可跨適應症轉譯。接下來至少在我們的策略中，就是新穎、更加新穎的聯合療法。而 BMS 擁有非常豐富的腫瘤產品組合。

BioNTech has also an important portfolio of oncology assets. And what we are doing, we are combining now -- we started the combination of pumitamig with these other drugs that represent an enabler for novel regimens, also using some combination with external partners. On our internal side, we started the combination with our Iza-bren ADC, which is an EGFR HER3 ADC. You will see data, as Chris was mentioning, at ASCO in esophageal, it's (inaudible) negative -- is a very active ADC. And I think with pumitamig can represent a very powerful regimen.

BioNTech 也擁有重要的腫瘤資產組合。而我們正在做的是把 pumitamig 與這些其他藥物進行聯合——我們已開始這些聯合，這些藥物可作為新療程的促成者（enabler），也會與部分外部合作夥伴進行聯合。在內部方面，我們已開始與我們的 Iza-bren ADC 聯合，這是一個 EGFR HER3 ADC。正如 Chris 提到的，你們會在 ASCO 看到食道的數據，它是（聽不清）陰性——是一個非常活躍的 ADC。我認為與 pumitamig 聯合可形成非常強而有力的療程。

We started a combination with our PRMT5 inhibitor, our Navlimetostat, a very (inaudible) drug. So in summary, I have to say that the partnership with BioNTech is moving very well because we are progressing the development of this drug with speed. We think we are very well positioned to make this drug as a potential new backbone in immuno-oncology and generating the next regimens very powerful cancer patients across indications.

我們也開始與我們的 PRMT5 抑制劑 Navlimetostat 聯合，這是一個非常（聽不清）的藥物。總結來說，我必須說與 BioNTech 的合作進展非常順利，因為我們正以速度推進這項藥物的開發。我們認為我們處於非常有利的位置，可望讓這項藥物成為免疫腫瘤學中的潛在新基石（backbone），並產生下一代療程，為跨適應症的癌症患者帶來非常強大的方案。

Yes. Geoff, thanks for the question. As it relates to Qvantig, we're pleased with the Qvantig launch performance. Our teams are executing well. And we're seeing use across multiple tumor types.

是的。Geoff，謝謝你的問題。就 Qvantig 而言，我們對 Qvantig 的上市表現感到滿意。我們的團隊執行得很好。我們也看到其在多種腫瘤類型中的使用。

We're seeing uptake in our monotherapy indications as well as in combination treatment, so in RCC, in gastric cancer, and in melanoma. We're continuing to hear positive feedback from community oncologists that Qvantig improves practice efficiency with a three-minute in-office injection and that patients prefer Qvantig when offered the opportunity versus the IV formulation.

我們看到它在單藥治療適應症以及聯合治療中都有採用，因此在 RCC、胃癌與黑色素瘤皆是如此。我們持續聽到社區腫瘤科醫師的正面回饋：Qvantig 透過三分鐘的門診注射提升了診療效率，而且當提供選擇時，患者相較於靜脈注射（IV）劑型更偏好 Qvantig。

So we've now delivered over 10% conversion from IV to Qvantig in the US in just over a year on the market, and we're tracking well against our expectations, and we remain confident in our expectation that physicians will convert approximately 30% to 40% of IV business in the next two years.

因此，在美國上市僅一年多，我們已實現超過 10% 從 IV 轉換到 Qvantig 的轉換率；目前進度符合我們的預期。我們仍然有信心，醫師在未來兩年將把約 30% 到 40% 的 IV 業務轉換為 Qvantig。

Alexandria Hammond, Wolfe Research.

Alexandria Hammond，Wolfe Research。

On milvexian, given the size and breadth of the Librexia program, it seems like there's probably a rich set of outcomes between the clean win and miss. Can you help us think through how you'd approach a subgroup analysis, particularly for patients where the risk/reward calculus might be more favorable for Factor XI. And to the extent that the top line doesn't meet that primary endpoint cleanly, is there a path where a specific patient population still supports a meaningful commercial opportunity?

關於 milvexian，鑑於 Librexia 計畫的規模與廣度，看起來在「明確成功」與「失敗」之間，可能存在一組相當豐富的結果。你能否協助我們思考你們會如何進行亞組分析（subgroup analysis），特別是對於那些風險／報酬權衡可能更有利於第 XI 因子（Factor XI）的患者？以及如果整體（top line）結果未能乾淨地達到主要終點（primary endpoint），是否仍有一條路徑，使特定患者族群仍能支持具意義的商業機會？

I'll have Cristian take that, and then, Adam, you can add any color commentary as you need to.

我先請 Cristian 回答，接著 Adam 你可以視需要補充任何評論。

I mean, Alex, let me start that to tell that we continue to be on track by the end of the year with both AFib and SSP. These trials are event driven. We remain blinded. As said, the DMC continues the oversight to both studies. We are at a point in which we -- this give us confidence that we are progressing on the right way with both efficacy and safety.

Alex，我先說，我們仍按計畫在今年年底前取得 AFib 與 SSP 兩項試驗的結果。這些試驗是事件驅動（event driven）。我們仍維持盲態（blinded）。如前所述，DMC 持續對兩項研究進行監督。我們目前所處的狀態——這讓我們有信心，我們正以正確的方式推進，兼顧療效與安全性。

Everything is continuing as planned. In AFib, the study will test non-inferiority versus apixaban. And then we will have superiority testing for bleedings. Based on what we have seen in other trials recently and based on the expectation and how we size and power the study, I think we are very much on track with both the endpoints to show non-inferiority and superiority in bleedings.

一切都按計畫進行。在 AFib 中，研究將檢驗相較於 apixaban 的非劣性（non-inferiority）。接著我們將對出血（bleedings）進行優越性（superiority）檢驗。基於我們近期在其他試驗中看到的情況，以及基於我們對研究規模設計與統計檢定力（power）的預期，我認為我們非常按軌道前進，有望同時在兩個終點上顯示非劣性，並在出血方面顯示優越性。

Adam.

Adam。

Yes. Alex, as it relates to commercial opportunity, Milvexian represents a significant opportunity commercially. There is a need for a medicine with low bleeding risk, both in Afib and in SSP. And we think there's a significant advantage to having both indications. We would expect broad adoption.

是的。Alex，就商業機會而言，Milvexian 在商業上代表一個重大的機會。在 Afib 與 SSP 兩個領域，都需要一種出血風險低的藥物。我們認為同時擁有這兩個適應症具有顯著優勢。我們預期會被廣泛採用。

As we talked about previously, fear of bleeding continues to be the main reason why physicians hold back from utilizing Factor Xa in more patients. And despite the highly effective dose like Eliquis, roughly 40% of patients who should be anticoagulated are either untreated, underdosed or they discontinue treatment, and that's driven largely by concerns around bleeding risk. So this leaves a meaningful unmet need across a substantial number of patients.

如同我們先前談到的，對出血的恐懼仍然是醫師不願在更多病人身上使用 Factor Xa 的主要原因。即使像 Eliquis 這樣在適當劑量下高度有效，約有 40% 應該接受抗凝治療的病人不是未治療、就是劑量不足，或是中止治療，而這在很大程度上是由對出血風險的擔憂所驅動。因此，這在相當多的病人族群中留下了重要的未被滿足需求。

And as a reminder, this study in AFib was designed to demonstrate a superior bleeding profile compared to Eliquis with comparable efficacy. So we believe this profile is going to drive significant demand and will be important for both patients and providers. And as Cristian said, we're looking forward to the data readout at the end of this year, and we think this has true blockbuster potential.

另外提醒一下，這項 AFib 研究的設計，是要在療效相當的前提下，相較於 Eliquis 展現更優異的出血表現。因此我們相信，這樣的特性將帶動顯著需求，並且對病人與醫療提供者都很重要。正如 Cristian 所說，我們期待今年底的數據揭盲，我們認為這具有真正的重磅藥（blockbuster）潛力。

Chris Schott, JPMorgan.

JPMorgan 的 Chris Schott。

Just two for me. Maybe first, can you just talk about Camzyos dynamics post your competitor approval? Just what are you seeing in the market? And just how you're thinking about that evolving?

我有兩個問題。第一個，能否談談在競品獲批之後，Camzyos 的動態？你們在市場上看到了什麼？以及你們如何看待其後續演變？

And the second one for me was coming back to the CELMoDs that with kind of some of this initial clinical data has read out. Can you just elaborate a little bit more the role in the market you see for those products based on these initial data sets? And how much of the -- your excitement here is based more on the future readouts versus what we're seeing initially here?

第二個問題是回到 CELMoDs。隨著一些初步臨床數據已經讀出，能否再多談一點：基於這些初步數據集，你們認為這些產品在市場上的角色是什麼？以及你們的興奮程度有多少是更多基於未來的讀出，而不是目前初步看到的結果？

Thanks for the question, Chris. Adam, I think you can take both.

謝謝你的問題，Chris。Adam，我想你可以一起回答。

Yes. Thanks, Chris. So Camzyos continues to have very good momentum. Again, our commercial teams are executing very well in the field. We are seeing continued strong new patient starts, coupled with high persistency rates.

是的，謝謝，Chris。Camzyos 仍然保持非常好的動能。我們的商業團隊在前線執行得非常到位。我們看到新病人啟用持續強勁，同時治療持續率也很高。

Physician and patient feedback are very favorable and physicians consistently cite the significant and rapid improvement in symptoms, and we're seeing very low drop-off rates. In fact, we are approaching 25,000 patients now prescribed Camzyos in the US with thousands more prescribed internationally.

醫師與病人的回饋都非常正面；醫師一再提到症狀顯著且快速改善，我們也看到非常低的停用率。事實上，目前在美國已有接近 25,000 名病人被開立 Camzyos，國際上還有數千名病人被開立。

As far as what we're seeing in the field, we've been planning for competition for some time. HCPs continue to reinforce that they see little differentiation. It's still early. Some physicians have started one or two patients on the competition, and they are still operationalizing their own REMS program. But we also hear consistently that the Camzyos REMS process is very clear and the infrastructure and workflow that have been established now for four years are very clear.

就我們在前線看到的情況而言，我們已經為競爭準備了一段時間。醫療專業人員（HCPs）持續強調他們認為差異化不大。現在仍屬早期。有些醫師已讓一兩位病人使用競品，而他們也仍在落實自己的 REMS 計畫。但我們也持續聽到，Camzyos 的 REMS 流程非常清楚，而且過去四年已建立的基礎設施與工作流程也非常明確。

And thus, PLs have shared they'll use the Camzyos dosing and echo regimen at four weeks. So we see this as a positive. And why is that? Because roughly 90% of patients on Camzyos are on the 5-milligram starting dose. And it's simply dose titration to 10 milligrams.

因此，關鍵意見領袖（PLs）也分享他們會採用 Camzyos 在四週時的劑量與心臟超音波（echo）方案。我們將此視為正面訊號。原因是什麼？因為約 90% 的 Camzyos 病人使用 5 毫克起始劑量，接著只是將劑量滴定到 10 毫克。

So it's 5 or 10 representing 90% of our business, which is effective for the majority of patients. Camzyos patients feel better in a matter of weeks, where we see from the competition requires multiple titration steps to reach an effective dose. And so our teams were well prepared for the launch of aficamten, and we remain confident that we'll be the leader in the space longer term. So as it relates to iberdomide, I think we're really excited about the launch of iber. And I know that Chris and Cristian have talked about this.

因此 5 或 10 毫克就代表了我們約 90% 的業務量，且對多數病人有效。Camzyos 病人在數週內就會感覺好轉；而我們看到競品需要多次滴定步驟才能達到有效劑量。因此，我們的團隊已為 aficamten 的上市做好充分準備，我們仍有信心長期會是此領域的領導者。至於 iberdomide，我們對 iber 的上市感到非常興奮。我知道 Chris 和 Cristian 也談過這點。

And so I think there are a few areas that I could point to. Number one, with iberdomide, this is an area that we know very, very well in multiple myeloma. We see that for multiple myeloma, it's a highly competitive, it's a fragmented market, but there remains a need for more effective and safe options that can address the majority of patients, particularly those patients who are treated in the community setting. And that's 70% to 80% of patients.

我想我可以指出幾個面向。第一，對於 iberdomide，這是我們在多發性骨髓瘤領域非常、非常熟悉的領域。我們看到多發性骨髓瘤是一個競爭非常激烈且分散的市場，但仍然需要更有效且更安全、能涵蓋大多數病人的選項，特別是那些在社區醫療環境接受治療的病人，而這占了 70% 到 80%。

What we hear from physicians, they're excited about oral, low burdensome regimens that can find a better experience for their patients. And we're confident that iberdomide will provide a balance of high potency, manageable toxicity, combinability with daratumumab with the convenience of an oral treatment that amplifies the efficacy of IMiD-based regimens.

我們從醫師那裡聽到的是，他們對口服、負擔較低的治療方案感到興奮，因為這能為病人帶來更好的治療體驗。我們有信心 iberdomide 能在高效力、可管理的毒性、可與 daratumumab 併用，以及口服治療的便利性之間取得平衡，並強化以 IMiD 為基礎的治療方案之療效。

So our goal is to make both Iber and Mezi foundational in multiple myeloma, replacing Revlimid and Pomalyst in second line over time in the community, longer term serving as partners for T-cell redirecting therapies and cell therapy. So we know the work that we need to do to establish both Iber and Mezi in the market, and we are very excited to bring both of these important medicines to patients because we believe this is a real attractive commercial opportunity.

因此，我們的目標是讓 Iber 與 Mezi 都成為多發性骨髓瘤的基礎用藥，並在社區端隨時間推進於二線治療中取代 Revlimid 與 Pomalyst；長期而言，作為 T 細胞重導向療法與細胞治療的搭配夥伴。我們清楚知道要在市場上建立 Iber 與 Mezi 的定位需要做哪些工作，也非常期待把這兩款重要藥物帶給病人，因為我們相信這是一個非常具吸引力的商業機會。

And Adam, allow me to step in. Chris, I want to use the opportunity you mentioned in the question on Camzyos because I received -- we received often the question about the non-obstructive HCM plans. I think, first of all, let me start that the level of benefit expected in non-obstructive is different than obstructive because the heterogeneity of patients and disease is much higher.

Adam，讓我補充一下。Chris，我想利用你在 Camzyos 問題中提到的機會，因為我——我們經常收到關於非阻塞型 HCM 計畫的問題。我想首先說，非阻塞型的預期獲益程度與阻塞型不同，因為病人與疾病的異質性要高得多。

That said, we have learned a lot from ODYSSEY. We know better what the patients and which diseases they are affected by that can benefit most from a myosin inhibitor like Camzyos. So I want to announce that we are planning now to run a new, more focused study in non-obstructive HCM. And then, of course, the detail of it will be highlighted in ClinicalTrials.gov, why we are progressing this work.

話雖如此，我們從 ODYSSEY 學到了很多。我們更清楚哪些病人、以及哪些受影響的疾病狀態，最能從像 Camzyos 這樣的肌球蛋白抑制劑中獲益。因此我想宣布，我們目前正計畫在非阻塞型 HCM 中進行一項新的、更聚焦的研究。當然，相關細節會在 ClinicalTrials.gov 上說明，並解釋我們為何推進這項工作。

Evan Seigerman, BMO Capital Markets.

BMO Capital Markets 的 Evan Seigerman。

And another one for Cristian. So you really inherited the design and kind of the milvexian trials. Can you walk me through the aspects of the trial design, patient selection that increased your confidence in a potentially successful readout later this year?

我還有一個問題給 Cristian。你其實是接手了 milvexian 試驗的設計與整體規劃。你能否帶我了解一下：試驗設計、病人選擇等哪些面向，讓你對今年稍晚可能成功的讀出更有信心？

Cristian.

Cristian。

Thank you, Evan, for the question. I think your question is referring to Afib specifically, I imagine, because SSP yes. So in Afib, let me tell you that, first of all, the data are solidly based on a Phase II study that we run in total knee replacement that is a very good surrogate for antithrombotic drugs. We learned a lot from Eliquis in that space, and we know the predictivity value of that kind of population for antithrombotic agents.

謝謝你，Evan，提出這個問題。我想你的問題應該是特別指 Afib，我猜，因為 SSP 是的。在 Afib 方面，我先說，這些數據是穩固地建立在我們於全膝關節置換所進行的第二期研究之上，而那是一個對抗血栓藥物非常好的替代指標。我們從 Eliquis 在該領域學到很多，也知道那類族群對抗血栓藥物的預測價值。

I think the very elegant, refined work that has been done with Milvexian was in selecting the dose for AFib. That was -- in that trial, we tested multiple dose levels. And ultimately, we landed with 100 milligram twice a day that is a much higher dose, for instance, that we are using in SSP. But it's a dose that gave us the confidence based on the work that has been done, the modeling and the work that we were able to bring in this -- in the Phase II part, give us confidence to have at least the same level of efficacy than what we expected with apixaban, preserving, of course, the bleeding value.

我認為 Milvexian 所做的非常精巧、精煉的工作，是在為 AFib 選擇劑量。在那項試驗中，我們測試了多個劑量水準。最終我們選定每日兩次 100 毫克；例如，這比我們在 SSP 使用的劑量高得多。但基於已完成的工作、模型建構，以及我們在這——在第二期部分所能帶入的分析，這個劑量讓我們有信心至少能達到與 apixaban 預期相同的療效，同時當然也保留其出血方面的價值。

Going specifically to your question, the design of the study is to be able to show a non-inferiority versus apixaban in a head-to-head comparison in a very well-sized study. We recruited 20,500 patients. So very well powered for non-inferiority margins. We disclosed these margins. Of course, they go from 0.8 to 1.3. And we will then when a non-inferiority will be met, test superiority for bleedings.

針對你的問題，研究設計是要在一項樣本數非常充足的試驗中，與 apixaban 進行頭對頭比較，以證明非劣效性。我們招募了 20,500 名病人，因此在非劣效性界值上具有非常好的統計力。我們也已揭露這些界值；當然，範圍是從 0.8 到 1.3。接著在達成非劣效性之後，我們將檢驗出血方面的優越性。

We test with split alpha for measured bleeding and non-measured clinical relevant bleedings because I want to link what Adam was telling. This is a major problem in the clinical setting. And being able to show that the drug provide benefit in terms of decreasing the bleedings will be very important in the marketplace. So as I said, the study is fully powered, well designed, and pick, in my view, the right dose to being able to show what the study predefined criteria should meet.

我們針對可量測出血與不可量測但具臨床相關性的出血，採用分割 alpha（split alpha）來進行檢定，因為我想把 Adam 剛才提到的內容連結起來。這在臨床情境中是一個重大問題。而能夠證明該藥物在降低出血方面帶來效益，對市場端將非常重要。所以如我所說，這項研究具備充分的統計把握度、設計良好，並且在我看來，選擇了正確的劑量，才能夠呈現並滿足研究預先定義的判定標準。

Michael Yee with UBS.

UBS 的 Michael Yee。

Following up on the design of the Milvexian study. If you take a look at the recent AFib results, you can see that the stroke rates are quite historically a lot lower than they were back in the original days of Eliquis. So just thinking about whether you've taken that into consideration and to what extent you think that impacts the study design and whether you think that there's any chance that the study results will ultimately end up in 2027, which could end up being more positive for you than in 2026?

延續 Milvexian 研究設計的問題。如果你看看近期 AFib 的結果，可以看到中風發生率在歷史上明顯比當年 Eliquis 最初時期低很多。所以我在想，你們是否已將這點納入考量？你們認為這在多大程度上會影響研究設計？以及你們是否認為研究結果最終有任何可能會落在 2027 年（而不是 2026 年），這樣對你們而言可能會比 2026 年更正面？

Cristian.

Cristian。

Okay. Thank you, Michael, for the question. I don't -- we cannot disclose baseline characteristics and which kind of events we are recruiting. By the way, we are blinded, of course, to the study. What I can tell you, again, is that the AFib study, Librexia study has the right sample size and of course, has a predefined number of events.

好的。謝謝你，Michael，這個問題。我不——我們無法揭露基線特徵以及我們正在招募的是哪些類型的事件。順帶一提，我們當然對研究是盲態的。我能告訴你的是，再次強調，AFib 研究、Librexia 研究具備適當的樣本數，當然也有預先定義的事件數。

We are recruiting the events as expected. And the events predefined number is for efficacy and of course, for safety. So we are on track by year-end. It's event-driven. We are in April. We will see later in the year if this event rate will change or not. For the moment, we are on track for a year-end readout.

我們正如預期地招募事件。而預先定義的事件數是用於療效，當然也用於安全性。因此我們在年底前的進度是如期的。這是一項事件驅動（event-driven）的研究。我們現在在四月。我們會在今年稍晚看看事件率是否會改變。目前而言，我們仍按計畫在年底讀出結果。

Akash Tewari, Jefferies.

Jefferies 的 Akash Tewari。

So for your Cobenfy Alzheimer's psychosis studies, you have several trials, but I know ADEPT-4 requires patients to have a confirmed Alzheimer's diagnosis using both imaging and blood-based biomarkers. Can you talk about why you added that criteria for the study? And was it based on any issues you saw with the ADEPT-2 trial conduct?

關於你們 Cobenfy 的阿茲海默症精神病（Alzheimer's psychosis）研究，你們有好幾個試驗，但我知道 ADEPT-4 要求病人必須透過影像與血液型生物標記（blood-based biomarkers）兩者來確認阿茲海默症診斷。你能談談為什麼在研究中加入這個條件嗎？這是否是基於你們在 ADEPT-2 試驗執行上看到的任何問題？

And then just on CELMoDs, can you talk about your confidence on the SUCCESSOR-1 study, which goes head-to-head against Pomalyst showing a clinically meaningful effect size based on the results you saw in SUCCESSOR-2?

另外關於 CELMoD，你能談談你們對 SUCCESSOR-1 研究的信心嗎？該研究是與 Pomalyst 進行頭對頭比較，而你們是基於在 SUCCESSOR-2 看到的結果，認為能展現具臨床意義的效應量（effect size）。

Cristian.

Cristian。

Thank you, Akash. The Cobenfy ADEPT-4 decision to go into a biomarker selected population was based in a try to decrease the heterogeneity in the patient population. As you know, ADEPT-2 was a study that was already ongoing in the moment we acquired Cobenfy. And we wanted to have a more predefined patient population to be recruited into an Alzheimer's disease psychosis setting. This is why we took this approach of biomarker positivity that can be done through plasma or radiologically.

謝謝你，Akash。Cobenfy 的 ADEPT-4 決定採用生物標記篩選族群，是基於希望降低病人族群的異質性。如你所知，ADEPT-2 是在我們收購 Cobenfy 時就已經在進行中的研究。我們希望在阿茲海默症精神病的情境中，招募一個更明確預先定義的病人族群。因此我們採取生物標記陽性（biomarker positivity）的方式，可透過血漿或影像學來判定。

And I think, of course, this is increase the confidence that the right patients are treated in the trial, even if increase a little bit the operational challenges because, of course, we need a predefined number of patients biomarker positive to run. So the screening failures are a little bit higher.

我認為，當然，這會提升我們對於在試驗中治療到正確病人的信心，即使在營運執行上會稍微增加一些挑戰，因為我們必須達到一定數量的生物標記陽性病人才能推進。因此篩檢失敗率會稍微高一些。

This is -- doesn't take out any confidence of the potential benefit that you can see also maybe in a trial like ADEPT-2, where we do not have a biomarker positive study because ultimately, you treat symptoms, but give more confidence that you have Alzheimer's patients. This is the main reason. We are not the only one doing this -- taking this approach in the space.

這——並不會降低我們對潛在效益的信心；你也可能在像 ADEPT-2 這樣的試驗中看到潛在效益，因為 ADEPT-2 並不是生物標記陽性設計，最終你治療的是症狀，但生物標記能讓你更有把握病人確實是阿茲海默症患者。這是主要原因。我們也不是唯一在這個領域採取這種做法的公司。

Going back to your second question on CELMoD, I think SUCCESSOR-2 was a very good news, not only because it -- and as you mentioned, SUCCESSOR-2 is an add-on study on top of KD, but because it came earlier than expected. We hit an interim PFS. You will see the data at ASCO, but you already know that when you hit an interim PFS, it means that you hit the bar that is higher according to the study, what the study was designed for.

回到你第二個關於 CELMoD 的問題，我認為 SUCCESSOR-2 是非常好的消息，不僅因為它——而且如你所提到，SUCCESSOR-2 是在 KD 基礎上加成（add-on）的研究——也因為它比預期更早出來。我們在期中分析達到 PFS。你會在 ASCO 看到數據，但你也已經知道，當你在期中分析就達到 PFS，代表你達到了研究設計所要求、且門檻更高的標準。

This is answering your question on SUCCESSOR-1. We believe mezigdomide is a very potent CELMoD. It's more potent than iberdomide, for instance, is a drug that can be very well combined with the standard of care regimens that we see, a little bit less with anti-CD38. This is why iberdomide is doing that job. But I believe that the level of efficacy we have seen and the design of the study let us believe that this drug can be better than Revlimid and pomalidomide.

這也回答你對 SUCCESSOR-1 的問題。我們相信 mezigdomide 是一個非常強效的 CELMoD。舉例來說，它比 iberdomide 更強效；而且它能與我們看到的標準治療（standard of care）方案很好地併用，與 anti-CD38 的併用相對少一些——這也是 iberdomide 在做的工作。但我相信，我們所看到的療效水準以及研究設計，使我們相信這個藥物可能優於 Revlimid 與 pomalidomide。

So the confidence of SUCCESSOR-1 is high. And of course, it's a higher bar because it's not an add-on is a replacement strategy, but I think that the [PDS] is high.

因此我們對 SUCCESSOR-1 的信心很高。當然，門檻也更高，因為這不是加成（add-on），而是替代策略（replacement strategy），但我認為 [PDS] 是高的。

Thanks, Cristian. And let me just also say that I'm glad to hear so many questions on CELMoDs. The CELMoD program, we're quite excited about. You're going to see exciting data at ASCO on Iber and Mezi. We shouldn't forget you'll also see data on golcadomide, which continues, in my view, to be a sleeper in the program just because of the high-quality data that we've seen thus far.

謝謝，Cristian。我也想補充一下，我很高興聽到這麼多關於 CELMoD 的問題。我們對 CELMoD 計畫相當興奮。你們將在 ASCO 看到 Iber 與 Mezi 的令人振奮的數據。我們也不應忘記，你們還會看到 golcadomide 的數據；在我看來，它在這個計畫中仍像是個被低估的項目（sleeper），原因在於我們迄今看到的數據品質非常高。

You'll see more of that data at ASCO. Of course, behind this, we've got additional degraders, BCL6-LDD, AR-LDD and this program in this platform is quite deep, and it's nice to see these data maturing as they are across each and every one of these programs. So it's exciting to see. So stay tuned for that at ASCO and beyond.

你們會在 ASCO 看到更多這些數據。當然，在此背後，我們還有其他降解劑（degraders），BCL6-LDD、AR-LDD，而這個平台的計畫深度相當可觀；也很高興看到這些數據在每一個計畫中都如期成熟與累積。所以這很令人期待。請持續關注 ASCO 以及之後的進展。

Louise Chen, Scotiabank.

Scotiabank 的 Louise Chen。

I wanted to ask you, in addition to your ADP study for Cobenfy, I know you have several additional potential indications for Cobenfy. And which of those additional indications are you most excited by?

我想問的是，除了你們針對 Cobenfy 的 ADP 研究之外，我知道你們還有幾個 Cobenfy 的其他潛在適應症。你們對其中哪些額外適應症最感到興奮？

And then secondly, you have a lot of different modalities in your cell therapy franchise and pipeline. And how do you see these all coming together to give Bristol a more comprehensive hold on the market?

第二，你們在細胞治療（cell therapy）事業與研發管線中有很多不同的技術模式（modalities）。你們如何看待這些整合在一起，讓 Bristol 在市場上取得更全面的布局與掌握？

Cristian and then Adam can provide color commentary.

Cristian，然後 Adam 可以補充說明。

So ADP, because we believe this is a huge medical need, and we believe Cobenfy can bring benefit based on what we have seen in schizophrenia. We are focusing our strategy in psychosis, specifically assessing hallucination delusions. And this is something that we have seen a patient really having an improvement in schizophrenia.

就 ADP 而言，因為我們相信這是巨大的未被滿足醫療需求（medical need），而且我們相信 Cobenfy 能帶來效益，這是基於我們在思覺失調症（schizophrenia）中看到的結果。我們把策略聚焦在精神病症狀（psychosis），特別是評估幻覺與妄想。這也是我們在思覺失調症病人身上確實看到改善的部分。

We wanted to have multiple shots on goals. This is why we have ADEPT-2 and ADEPT-4 that are similar studies with a difference of one is biomarker selected population, the other one not. And we have ADEPT-1 that is more a study that will assess how Cobenfy will avoid relapses. But we also designed ADEPT-5.

我們希望有多次命中目標的機會（multiple shots on goal）。因此我們有 ADEPT-2 與 ADEPT-4，這兩個是相似的研究，差別在於一個是生物標記篩選族群，另一個不是。另外我們還有 ADEPT-1，這更像是一個評估 Cobenfy 如何避免復發（relapses）的研究。但我們也設計了 ADEPT-5。

So we have now four shots on goal in this program because the base case I was mentioning before is having at least two positive. Things are changing maybe. And we believe this is an important setting. Cobenfy can bring benefit to patients. We want to really have multiple shots on goal.

所以目前在這個計畫中我們有四次命中目標的機會，因為我先前提到的基本情境（base case）是至少要有兩個試驗呈陽性。情況也許正在改變。我們相信這是一個重要的治療場景。Cobenfy 能為病人帶來效益。我們確實希望有多次命中目標的機會。

When talking -- when thinking of the other indication, bipolar disorder is the next one in line because we are expecting readout in 2027. We are testing Cobenfy specifically in mania in the context of bipolar disorders. And if you think this is very similar in terms of the productive symptoms that we see in AD psychosis. And then we have AD agitation.

談到——思考其他適應症時，雙相情感障礙（bipolar disorder）是下一個，因為我們預期在 2027 年讀出結果。我們正在雙相情感障礙的情境下，特別針對躁期（mania）測試 Cobenfy。而如果你想想，這在產出性症狀（productive symptoms）方面，與 AD 精神病（AD psychosis）中看到的非常相似。接著我們還有 AD 躁動（AD agitation）。

AD agitation is very related to psychosis because this is one symptoms that we have seen Cobenfy already providing benefit. So the confidence is high also for this. Agitation is coming in 2028, like cognition, AD cognition. And cognition is probably different mechanism. Psychosis is probably mediated by muscarinic receptor 4, cognition probably by muscarinic receptor 1 but Cobenfy is working on both. So this is where the confidence stay.

AD 躁動與精神病高度相關，因為這是我們已經看到 Cobenfy 能帶來效益的一個症狀。因此我們對此也有很高的信心。躁動的讀出時間會在 2028 年，與認知（cognition）、AD 認知相近。認知可能是不同機制：精神病可能由毒蕈鹼受體 4（muscarinic receptor 4）介導，而認知可能由毒蕈鹼受體 1（muscarinic receptor 1）介導，但 Cobenfy 兩者都作用。因此我們的信心維持在這裡。

So I would say the Cobenfy, we believe, can bring benefit in controlling these kind of symptoms in Alzheimer's, in bipolar patients and is a noncore asset for our portfolio in neuroscience. We are building -- I really would like you to start to see how we are building our portfolio in Alzheimer's with a Phase II asset and multiple Phase I assets that show the commitment that BMS has for this disease because we want to play in this disease.

所以我會說，我們相信 Cobenfy 能在控制阿茲海默症患者、雙相情感障礙患者的這類症狀方面帶來益處，而且它在我們的神經科學產品組合中屬於非核心資產。我們正在建立——我真的希望你開始看到我們如何以一個第二期資產以及多個第一期資產來建立我們在阿茲海默症領域的產品組合，這顯示了 BMS 對這個疾病的承諾，因為我們希望在這個疾病領域有所作為。

Yes. Just to add, Cristian, you did a great job covering much of our life cycle management program. But from a commercialization standpoint, I would say, stepping back, there are approximately 7 million patients diagnosed with Alzheimer's disease. And roughly 30% to 50% have psychosis and that's hallucination delusions and the vast majority have cognitive impairment. So this presents a real significant unmet need where there are no approved treatments today.

是的。補充一下，Cristian，你已經很完整地涵蓋了我們生命週期管理計畫的許多內容。但從商業化角度來看，退一步說，目前約有 700 萬名患者被診斷為阿茲海默症。而其中約 30% 到 50% 會出現精神病性症狀，也就是幻覺與妄想，而且絕大多數患者都有認知障礙。因此，這代表一個非常重大的未被滿足醫療需求，因為目前沒有任何核准的治療。

And we know that antipsychotics have significant safety limitations. They have movement disorders. They carry box warnings that are specific to elderly patients with dementia. And they're often treated and used inappropriately rather than treating the underlying psychiatric diseases, they leave patients with cognitive impairment, falls and fractures. And these are all really serious issues in long-term care facilities.

而我們知道，抗精神病藥物在安全性上有顯著限制。它們會造成運動障礙；並且帶有針對失智症高齡患者的黑框警語。而且它們常常被不當地使用——不是去治療潛在的精神疾病，反而讓患者出現認知受損、跌倒與骨折。這些在長期照護機構中都是非常嚴重的問題。

We believe that Cobenfy has potential to play a very important role in treating a number of Alzheimer's diseases. Safety becomes increasingly important in an elderly population where Cobenfy is not associated with EPS sedation, doesn't carry a box warning. And in those two areas, ADP and Alzheimer's disease cognition, Cobenfy will be the first and only product approved in those space.

我們相信 Cobenfy 有潛力在治療多種阿茲海默症相關疾病方面扮演非常重要的角色。在高齡族群中，安全性變得愈來愈重要；而 Cobenfy 不與 EPS（錐體外症候群）或鎮靜相關，也不帶黑框警語。而在這兩個領域——ADP 與阿茲海默症認知——Cobenfy 將會是該領域第一個且唯一獲核准的產品。

Let me -- thank you, Adam. Let me go back to your second question on cell therapy. I could discuss about cell therapy strategy in hematology or in autoimmune disease. I want to focus on autoimmune disease because probably it is newer and I think is more -- it is important that we explain the strategy that we want to put in place on the development, maybe on the commercial side. I believe that BMS has a very powerful platform in this space and with one aim, a reset immune system.

讓我——謝謝你，Adam。讓我回到你第二個關於細胞治療的問題。我可以談細胞治療在血液學或自體免疫疾病的策略。我想聚焦在自體免疫疾病，因為這可能比較新，而且我認為更——重要的是，我們需要解釋我們想在研發上、也許在商業端所要建立的策略。我相信 BMS 在這個領域擁有非常強大的平台，目標只有一個：重置免疫系統。

And to reset immune system, this is the strategy that we want to take, we decided to have a multimodal approach. This is why we have an autologous, an allogeneic and an in vivo platform. And I have to say this sets us apart compared to many other players in the space.

而要重置免疫系統，這就是我們想採取的策略：我們決定採用多模式（multimodal）的方法。這也是為什麼我們同時擁有自體、同種異體以及體內（in vivo）平台。我必須說，這讓我們相較於該領域許多其他參與者更具差異化。

If you think of these products, this can be transformative for patients with autoimmune disease because if you can eradicate B cells, you can provide benefit to patients with a severe or moderate state of the disease, but the vision can be to use this onetime treatment before the patients start to have the organs damaged by the autoimmune diseases.

如果你想想這些產品，對自體免疫疾病患者而言可能具有變革性，因為如果你能清除 B 細胞，就能為病情嚴重或中度的患者帶來益處；但更宏觀的願景是，在患者因自體免疫疾病而開始出現器官損傷之前，就以一次性治療介入。

The most advanced program is zola-cel, our autologous CAR-T. We have two ongoing pivotal studies, one in lupus and one in scleroderma. We have a multiple [arlo-cel] indication ongoing, and we see a level of activity that is unprecedented.

目前最先進的計畫是 zola-cel，我們的自體 CAR-T。我們有兩項正在進行的關鍵性研究，一項在紅斑性狼瘡，一項在硬皮症。我們也有多個 [arlo-cel] 適應症正在進行中，而且我們看到的活性水準是前所未見的。

And then we have in clinic now an allogeneic CAR-T that, of course, can represent a more accessible and scalable approach because from donor, you can manufacturing 100 cells. And so this can broaden up the access. But the real transformative thing can be in vivo. We acquired Orbital, an mRNA in vivo platform where you have the patients that are producing, manufacturing the cells in self -- Itself. So this is really -- can be transformative because it can really broaden up and give scalability in such a broad space like autoimmune disease.

接著我們目前也有一個同種異體 CAR-T 在臨床中，當然，這可能代表更容易取得且更可擴展的方式，因為從一位捐贈者，你可以製造 100 份細胞。因此這可以擴大可及性。但真正具變革性的可能是體內（in vivo）。我們收購了 Orbital，一個 mRNA 的體內平台，讓患者在自身體內產生、製造細胞——在自己體內。這真的——可能具有變革性，因為它能在像自體免疫疾病這麼廣泛的領域中，真正擴大規模並提供可擴展性。

So I hope I addressed the strategy. We want to be a player. We want to lead in this space. I think we are very well set to do that.

所以我希望我已經說明了策略。我們想成為參與者。我們想在這個領域領先。我認為我們已經具備非常好的條件做到這一點。

Terence Flynn, Morgan Stanley.

Morgan Stanley 的 Terence Flynn。

I'll keep it to one. Cristian, I appreciate the details on the milvexian AFib trial in terms of non-inferiority on the efficacy endpoint. But just was wondering if you could elaborate in terms of what differential it's powered for on bleeds for superiority? Or if you don't want to answer that question, what you think is a clinically relevant delta versus Eliquis that would drive reimbursement coverage?

我只問一個。Cristian，我很感謝你就 milvexian 心房顫動（AFib）試驗在療效終點的非劣性設計提供的細節。但我想請你進一步說明：在出血方面要做優效性比較時，這個試驗是以多大的差異（differential）來做檢定力（power）設計？或者如果你不想回答這個問題，你認為相較於 Eliquis，什麼樣臨床上具意義的差距（delta）會推動給付與報銷覆蓋？

Maybe I'll start and then, Adam, you can step in as you want. So Terence, again, the study is designed to show non-inferiority. Non-inferiority has margins that goes, as I was mentioning, we disclosed this margin while I can speak about it. They go from [0.8384] to [1.3] something. So we believe in the study and the preclinical and clinical work done in Phase II is set to show that the non-inferiority is met to have a similar activity on efficacy versus apixaban.

也許我先開始，然後 Adam 你可以視情況補充。Terence，再次說明，這項研究的設計是要證明非劣性。非劣性有其界值（margin），如我提到的，我們已揭露這個界值，所以我可以談。它大約從 [0.8384] 到 [1.3] 左右。因此我們相信，基於第二期所完成的臨床前與臨床工作，這項研究的設定能顯示達到非劣性，也就是在療效上相較於 apixaban 具有相近的活性。

It is possible that milvexian can have another ratio less than 1, but it's not needed. because clinically and maybe commercially, the success required to be similar and having a better bleeding profile in measured bleedings and clinically meaningful bleeding. And this is where the study, I think, is extremely well set and powered to show the non-inferiority and then superiority on the bleeding rates.

milvexian 的風險比也可能小於 1，但這不是必要條件。因為在臨床上、也可能在商業上，成功的要求是療效相近，同時在可量測的出血以及具臨床意義的出血方面有更好的出血特徵。而我認為這項研究在設計與檢定力上都非常到位，能先證明非劣性，接著在出血率上證明優效性。

Just from a coverage standpoint, Terence, what payers consistently tell us is that bleeding and particularly major bleeding is the single largest cost driver associated with oral anticoagulation therapy today. It's why Eliquis has significant share in the market. And payer discussions are suggesting that the potential of an improved benefit risk profile will be a strong value proposition, particularly around economic benefits.

Terence，從給付覆蓋的角度來看，保險支付方一再告訴我們，出血——尤其是重大出血——是目前口服抗凝治療相關的最大單一成本驅動因素。這也是 Eliquis 在市場上占有顯著份額的原因。而與支付方的討論顯示，若能改善效益/風險特徵，將會是很強的價值主張，特別是在經濟效益方面。

And payers aren't necessarily anchored to a specific percentage threshold. What they're looking for is a clinically meaningful and statistically credible reduction in major bleeds that translates into fewer hospitalizations and fewer events that are clinically and economically important.

而支付方不一定會被某個特定的百分比門檻所框定。他們在尋找的是：在重大出血方面具有臨床意義且統計上可信的降低，並能轉化為更少的住院與更少在臨床與經濟上重要的事件。

Seamus Fernandez, Guggenheim Securities.

Guggenheim Securities 的 Seamus Fernandez。

Great. So if I may, just wanted to drill in a little bit on Admilparant and the opportunity there. Just from a commercial perspective, we're seeing a very robust potential combination market poised to emerge here. But obviously, the key is success in clinical programs. So just wanted to get, maybe, Cristian, a little bit more of your sense of what are the key risks as we evaluate Phase II to Phase III. And how do you see the opportunity beyond that?

很好。如果可以的話，我想更深入問一下 Admilparant 以及那裡的機會。從商業角度來看，我們看到一個非常強勁的潛在聯合用藥市場正準備在此出現。但顯然關鍵在於臨床計畫的成功。所以我想請教，也許 Cristian，你能否多談一點：在我們評估從第二期走向第三期時，主要風險是什麼？以及你如何看待其後續更大的機會？

When we look back at the Phase II, it incorporated a Bayesian analysis from a statistical perspective, there weren't that many patients on background therapy. So just trying to get a better understanding of how you see the risk reward heading into the IPF results and the PPF results?

回頭看第二期試驗，它在統計上納入了貝葉斯分析，而且接受背景治療的患者並不多。所以我想更了解你如何看待在 IPF 結果與 PPF 結果出爐前，風險/報酬的走向？

And then just for Adam, as you look at the evolution of this market, how are you looking at the impact of the current antifibrotic standard of care and the dropout rate that patients experience and suffer from versus some of the emerging data sets for other combinations in this setting like the treprostinil data?

另外想請教 Adam，當你看這個市場的演變時，你如何看待目前抗纖維化標準治療的影響，以及患者所經歷與承受的停藥率（dropout rate），相較於在此情境下其他聯合治療的新興資料集，例如 treprostinil 的數據？

Cristian and Adam.

Cristian 和 Adam。

Seamus, the -- let me start with the target. LPA1 inhibition is important because it's working in three dimensions in the fibrotic process in IPF and PPF. Fibrosis, inflammation and also repair. So this is the novelty of the target. And I think Admilparant is the first-in-class in this space for both IPF and PPF.

Seamus，讓我先從標的談起。LPA1 抑制很重要，因為它在 IPF 與 PPF 的纖維化過程中，從三個面向發揮作用：纖維化、發炎，以及修復。因此這就是該標的的新穎之處。而我認為 Admilparant 在 IPF 與 PPF 兩個領域都是同類首創（first-in-class）。

The goal here is to improve upon efficacy, but also to have a differentiated tolerability. You know there are drugs that the patient can use today that have some GI issues, some cough issues. So Admilparant profile is very different, very differentiated.

這裡的目標是提升療效，同時也要有差異化的耐受性。你知道，患者目前可用的一些藥物會有腸胃道（GI）問題、咳嗽問題。因此 Admilparant 的特徵非常不同、差異化非常明顯。

The conviction on this program is sitting on the Phase II results in both IPF and PPF. We have more than 60% improvement versus placebo in the lung function decline with 60-milligram BID. And you know we tested different doses and the dose relationship is very clear. This is another nuance very important that we put in the Phase III that give me confidence in what we are doing because we are running both studies, IPF and PPF with two doses, 60 and 120. The dose relationship and the benefit of having a higher dose was very clear, deeper efficacy while the dose is increasing.

我們對這個計畫的信心來自於第二期在 IPF 與 PPF 的結果。在 60 毫克、每日兩次（BID）劑量下，相較於安慰劑，我們在肺功能下降方面看到超過 60% 的改善。而且你知道，我們測試了不同劑量，劑量反應關係非常清楚。這是另一個非常重要的細節，也被我們納入第三期設計，讓我對我們正在做的事更有信心，因為我們在 IPF 與 PPF 兩項研究中都採用兩個劑量：60 與 120。隨著劑量增加，劑量反應關係以及較高劑量帶來的益處非常清楚——更深的療效。

DMC also for these trials are continues to monitor and reviewing the conduction of the study, safety and efficacy and tell us to continue as planned. So we do not see any flag, especially on safety side in terms of hypotension syncope events even in overall in the trial. So two shots on goal with 60 and 120 in a very well-designed power studies.

DMC 也針對這些試驗持續監測並審查研究的執行情況、安全性與療效，並告知我們按計畫繼續進行。因此我們沒有看到任何警訊，特別是在安全性方面，就算在整體試驗中也未見低血壓、暈厥事件等問題。所以在設計非常完善、具備足夠統計效力的研究中，我們有 60 與 120 兩個劑量可望成功。

The Phase II and the Phase III population are very similar. We tried and the teams did a very good job in ensuring consistency and in trying to have as much as possible in Phase III what we did in Phase II. In your question on -- specifically on the design of the trial, in both trials in IPF, we stratify based on prior treatments, pirfenidone and nintedanib or nothing. So we can use add-on in patients that don't receive any treatment. And in PPF, there is stratification based on usage or not of antifibrotic.

第二期與第三期的受試族群非常相似。我們嘗試，而團隊也做得非常好，確保一致性，並盡可能在第三期延續第二期所做的設計。針對你提到的——特別是試驗設計，在兩個 IPF 試驗中，我們依既往治療進行分層：pirfenidone、nintedanib 或未接受治療。因此我們可以在未接受任何治療的患者中使用加成治療（add-on）。而在 PPF 中，則依是否使用抗纖維化藥物進行分層。

So the studies will answer that question, and the drug can be used on top of standard of care or as a single agent. Very high confidence on how this program has been delivered on the target, execution and looking really forward to the results.

因此，這些研究將回答該問題，而該藥物可在標準治療（standard of care）之上使用，或作為單藥使用。我們對此計畫在目標族群上的交付方式、執行力都非常有信心，也非常期待結果。

Adam.

Adam。

Just quickly, Seamus. We're excited about this program as well. We believe that Admilparant has the potential to play a meaningful role in both IPF and PPF with an improved efficacy and tolerability profile, as Cristian described. there remains a significant need for improved therapies that slow disease progression that are well tolerated and ultimately help patients manage their disease.

Seamus，我簡短補充一下。我們也對這個計畫感到振奮。我們相信 Admilparant 具備在 IPF 與 PPF 中扮演重要角色的潛力，並如 Cristian 所述，可能帶來更佳的療效與耐受性表現。目前仍然非常需要能夠減緩疾病進展、且耐受性良好，並最終幫助患者管理疾病的改良療法。

As you were alluding to, GI tolerability remains a significant barrier where approximately 50% to 60% of patients on treatment today are discontinuing therapy by 12 months with current standard of care. And even what we're seeing with the newest approved products, the diarrhea rate is roughly 40%.

如你所提到的，腸胃道（GI）耐受性仍是重大障礙：以目前標準治療來看，約有 50% 到 60% 的治療中患者在 12 個月內會停止治療。即便是我們看到最新核准的產品，腹瀉發生率也約為 40%。

What we're hearing from our thought leaders is that Admilparant has the potential to be foundational as a first-line option and has the versatility of being used in combination given the expected efficacy and tolerability profile and unmet needs in the marketplace. So we've got important prelaunch activities that are underway now, and we are very much looking forward to the data readout in the second half of the year.

我們從意見領袖那裡聽到的是，Admilparant 有潛力作為第一線選項的基礎用藥（foundational），並且因其預期的療效與耐受性表現，以及市場上未被滿足的需求，而具備可用於聯合治療的多樣性。因此，我們目前已啟動重要的上市前（prelaunch）活動，也非常期待今年下半年數據讀出。

Operator, can we please take our last question.

接線員，請幫我們接最後一個問題。

The last question today will come from Mohit Bansal with Wells Fargo.

今天最後一個問題來自 Wells Fargo 的 Mohit Bansal。

So I have a question on pumitamig. So your competitor has signaled that VEGF PD-1 compared to an IO or a PD-1 may be able to show a minimal regression in hazard ratio when you go from PFS to OS. We saw a regression when we compare it to chemo, but with the IO combo, it may not be the same situation.

我有一個關於 pumitamig 的問題。你們的競爭對手指出，VEGF PD-1 相較於一個 IO 或 PD-1，當你從 PFS 走到 OS 時，危險比（hazard ratio）可能只會出現很小的回歸。我們看到與化療相比時有回歸，但若是與 IO 聯合療法相比，情況可能不同。

How are you thinking about that given that Bristol is probably the only company with two IO combos on the market, and you have seen data for both LAG-3 as well as CTLA-4 on top of PD-1. So how are you thinking about this sort of regression from PD-1 to -- from PFS to OS given in the context of VEGF PD-1, it's kind of an important investor debate right now.

你們如何看待這點？尤其 Bristol 可能是市場上唯一同時擁有兩種 IO 聯合療法的公司，而且你們也看過 LAG-3 以及 CTLA-4 加在 PD-1 之上的數據。因此，在 VEGF PD-1 的背景下，你們如何看待從 PFS 到 OS、相對於 PD-1 的這種回歸？這也是目前投資人很重要的辯論議題。

Cristian?

Cristian？

Thank you, Mohit, for the question. Let me start on the way we deliver these two mechanisms. I truly believe bispecifics are a better way to deliver two different mechanisms than using two different antibodies because you are much more on target, you are much more selective in delivering them and potentially, you can decrease also the off-target issues like adverse event. So there is another important learning that we have had that we are having every day with these drugs. Our pumitamig is a safe drug.

謝謝你，Mohit，這個問題。我先從我們如何傳遞這兩種機制談起。我確實相信，雙特異性抗體（bispecifics）是傳遞兩種不同機制的更好方式，相較於使用兩個不同抗體，因為你能更聚焦於目標、更具選擇性地傳遞，並且可能也能降低非靶向（off-target）問題，例如不良事件。另一個重要的學習是，我們每天都在這些藥物上持續累積經驗。我們的 pumitamig 是一個安全的藥物。

The safety is very predictable. The combinability is very high. So we know VEGF is impacting PFS. This is what also you are mentioning. And I think that we will see where the data are maturing, we will see even in a few weeks at ASCO, what this PFS improvement can translate in terms of OS.

其安全性非常可預測，可聯合用藥的能力也很高。因此我們知道 VEGF 會影響 PFS，這也是你所提到的。我認為，隨著數據逐漸成熟，我們將看到 PFS 的改善能在 OS 上轉化到什麼程度；甚至在幾週後的 ASCO，我們就會看到相關結果。

My base case, Mohit, is that if I have a drug that give me a good PFS gain and statistical significance OS gain that will be without increasing the safety in a dramatic way, it is good enough because then I can use this as a backbone and I can improve even further pairing other mechanisms that can continue to increase the PFS gain and potentially translate even in a better OS.

Mohit，我的基本情境（base case）是：如果我有一個藥物能帶來良好的 PFS 增益，並且在不大幅增加安全性風險的情況下，帶來具統計顯著性的 OS 增益，那就已經足夠好；因為接著我可以把它作為骨幹（backbone），再搭配其他機制進一步提升，持續增加 PFS 增益，並可能轉化為更好的 OS。

I don't think we can be so -- we can simplify so much like in the past, the VEGF inhibitors did not translate in OS because here, we have the IO component. And we still don't know how much the VEGF part of the drug is giving us the upside for the IO. And it's possible actually that this give us an uplift also for OS. So I'm excited by these bispecifics.

我不認為我們可以像過去那樣把問題簡化——過去 VEGF 抑制劑未能轉化為 OS，但在這裡我們有 IO 成分。而且我們仍不清楚藥物中的 VEGF 部分，究竟為 IO 帶來多少額外上行空間。實際上，它也可能帶來 OS 的提升。因此我對這些雙特異性抗體感到興奮。

I'm excited very much about pumitamig and the plan that we are putting in place because I truly believe that this can be the backbone for future regimens for cancer patients across indications.

我也非常期待 pumitamig，以及我們正在制定的計畫，因為我確實相信，這可以成為未來跨適應症癌症患者治療方案的骨幹。

Thanks, Cristian, and thanks, everyone, for the questions. In closing, I just want to come back to where we started. We're doing what we said we would do. We're executing across the business, advancing a really differentiated pipeline that we think is going to strengthen the growth profile for the company, and operating consistently with financial discipline. And of course, that discipline enables us to have flexibility to invest in growth, to pursue business development where it makes sense, and ultimately deliver long-term value.

謝謝 Cristian，也謝謝各位的提問。最後我想回到我們一開始的重點：我們正在做我們說過會做的事。我們在整個業務上持續執行，推進一個高度差異化的研發管線，我們認為這將強化公司的成長輪廓，同時也一貫以財務紀律運營。當然，這份紀律也讓我們能保有彈性去投資成長、在合適之處推動業務發展（business development），並最終交付長期價值。

There's always more work to do, but the foundation we've built and the momentum we're seeing gives us confidence in the trajectory of the business.So with that, thanks for joining us today. And as always, the team is available for follow-ups. Have a good rest of the day.

總是還有更多工作要做，但我們所建立的基礎以及目前看到的動能，讓我們對業務發展軌跡充滿信心。那麼，感謝各位今天加入我們。一如往常，團隊也可就後續問題提供協助。祝各位今天接下來一切順利。

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

本次電話會議到此結束。感謝各位參加今天的簡報。您現在可以中斷連線。