施貴寶 (BMY) 2024 Q1 法說會逐字稿

Welcome to the Bristol-Myers Squibb First Quarter 2024 Earnings Conference Call. (Operator Instructions) Please note, today's event is being recorded.

歡迎參加百時美施貴寶 2024 年第一季財報電話會議。 （操作員說明）請注意，今天的活動正在錄製中。

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

現在我想將會議交給副總裁兼投資者關係主管 Tim Power。請繼續。

Thank you, and good morning, everyone. Thanks for joining us this morning for our first quarter 2024 earnings call. 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. As you'll note, we've posted slides to bms.com that you can use to follow along with for Chris and David's remarks.

謝謝大家，大家早安。感謝您今天早上參加我們的 2024 年第一季財報電話會議。今天早上與我一起發表準備好的演講的是我們的董事會主席兼首席執行官 Chris Boerner；和我們的財務長大衛埃爾金斯。參加今天電話會議的還有我們的首席商業化長 Adam Lenkowsky；以及我們的首席醫療官兼全球藥物開發主管 Samit Hirawat。您將注意到，我們已將幻燈片發佈到 bms.com，您可以使用這些幻燈片來了解 Chris 和 David 的演講。

Before we get started, I'll read our forward-looking statement. During this call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings.

在我們開始之前，我將閱讀我們的前瞻性聲明。在本次電話會議中，我們將就公司的未來計畫和前景發表前瞻性聲明。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。

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. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. 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.

這些前瞻性陳述代表了我們截至目前為止的估計，不應被視為代表我們截至未來任何日期的估計。即使我們的估計發生變化，我們特別不承擔更新前瞻性陳述的義務。我們還將重點關注我們的非公認會計準則財務指標，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 GAAP 指標的調整表可在 bms.com 上找到。

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

有了這個，我會把它交給克里斯。

Thank you, Tim, and good morning, everyone. Q1 was a busy quarter for us and a good start to 2024. Starting on Slide 4, and knowing what an active quarter we had, I wanted to start by telling you how we think about our performance across four dimensions.

謝謝蒂姆，大家早安。第一季對我們來說是一個忙碌的季度，也是2024 年的良好開端。績效。

First, the performance of our commercial portfolio was good and broadly in line with our expectations, even with some products impacted by inventory or gross to nets. Second, we made solid progress advancing our pipeline. Third, we closed four import transactions that strengthened our long-term growth profile during Q1. And fourth, we're taking decisive actions to improve productivity.

首先，我們的商業產品組合的表現良好，基本上符合我們的預期，即使某些產品受到庫存或毛淨值的影響。二是管道建設紮實推進。第三，我們完成了四筆進口交易，增強了我們第一季的長期成長前景。第四，我們正在採取果斷行動來提高生產力。

Taken together, Q1 performance was broadly aligned to our internal expectations. And importantly, there is no change to the underlying business outlook we provided in February. As you know, we've included the accounting impact of the recently closed transactions in our non-GAAP EPS guidance.

總而言之，第一季的業績與我們的內部預期基本一致。重要的是，我們在二月提供的基本業務前景並沒有改變。如您所知，我們已將最近完成的交易的會計影響納入我們的非 GAAP 每股盈餘指南中。

Let's turn to Slide 5 for some details. I'll start with some highlights on commercial performance. We've seen real strength across key brands, including Eliquis, Opdualag, Reblozyl, Yervoy and Breyanzi. And though the BCMA space remains competitive, our objective is to return Abecma to growth over time with the KarMMa-3 approval as we move into a larger patient population.

讓我們轉向幻燈片 5 以了解一些詳細資訊。我將從商業表現的一些亮點開始。我們看到了主要品牌的真正實力，包括 Eliquis、Opdualag、Reblozyl、Yervoy 和 Breyanzi。儘管 BCMA 領域仍然具有競爭力，但我們的目標是隨著 KarMMa-3 的批准，隨著我們進入更大的患者群體，讓 Abecma 恢復成長。

Turning to Opdivo, Camzyos and SOTYKTU. What's important about all three brands is that demand grew while revenue was impacted by other factors such as inventory and gross to nets. Today, we are seeing the inventory patterns for Opdivo and Camzyos normalizing. And for SOTYKTU, we're steadily building commercial script volume as access continues to improve this year. David will give you more details, but taken together, the commercial performance in Q1 is in line with our expectation and sets us up for the year.

轉向 Opdivo、Camzyos 和 SOTYKTU。對這三個品牌來說，重要的是需求成長，而收入卻受到庫存和毛淨值等其他因素的影響。今天，我們看到 Opdivo 和 Camzyos 的庫存模式正在正常化。對於 SOTYKTU 來說，隨著今年訪問量的不斷提高，我們正在穩步增加商業腳本量。大衛將向您提供更多細節，但總的來說，第一季的商業表現符合我們的預期，並為我們今年做好了準備。

Second, we made important progress advancing our pipeline. This includes two important cell therapy approvals, the initiation of new registration trials and important proof-of-concept data for Opdualag in lung cancer from a prespecified analysis of our Phase II during Q1. We're looking forward to starting a Phase III registrational trial versus standard of care in a segment consisting of about 20% to 30% of non-small cell lung cancer patients.

二是管道建設有重要進展。這包括兩項重要的細胞療法的批准、新註冊試驗的啟動以及 Opdualag 在肺癌中的重要概念驗證數據，這些數據來自我們第一季 II 期的預先指定分析。我們期待在由約 20% 至 30% 的非小細胞肺癌患者組成的細分市場中開始一項與標準護理相比的 III 期註冊試驗。

And not on this slide, but important for patients is milvexian, which has the potential to be the only oral Factor XIa medicine in AFib and ACS. The trials are continuing following the most recent DSMB review with enrollment accelerating.

這張投影片上沒有提到，但對病人很重要的是 Milvexian，它有潛力成為治療 AFib 和 ACS 的唯一口服 XIa 因子藥物。在最近的 DSMB 審查之後，試驗仍在繼續，註冊加速。

Third, we closed four important deals during the quarter. Across all four, we have added assets, capabilities and expertise that strengthen our ability to drive long-term growth as we exit the 2020s. Our team is driving performance of Krazati, the Rayze radioligand plant in Indiana is now operational. We're in the process of filing an application to supply clinical product for RYZ101 from the site. SystImmune's first-in-class bispecific ADC is advancing into global clinical trials in tumors, including lung and over time, breast cancer. And we are very excited about the potential of KarXT from Karuna, which I will review on Slide 6.

第三，我們在本季完成了四項重要交易。在這四個方面，我們都增加了資產、能力和專業知識，增強了我們在 2020 年代結束時推動長期成長的能力。我們的團隊正在推動 Krazati 的業績，位於印第安納州的 Rayze 放射性配體工廠現已投入運作。我們正在提交申請，從該網站提供 RYZ101 臨床產品。 SystImmune 的一流雙特異性 ADC 正在進入腫瘤的全球臨床試驗，包括肺癌和乳癌。我們對 Karuna 的 KarXT 的潛力感到非常興奮，我將在幻燈片 6 中對其進行回顧。

The team is on track and focused on two objectives: First, launch preparations are underway and on track for KarXT; second, we are executing against a robust clinical program for this important asset. On this slide, you can see the significant unmet need in schizophrenia and highlights of data recently presented for KarXT. These data demonstrate its compelling long-term efficacy as KarXT was associated with significant improvements in symptoms of schizophrenia across all efficacy measures without evidence of metabolic or movement disorder side effects.

團隊已步入正軌並專注於兩個目標：首先，KarXT 的發射準備正在進行中，併步入正軌；其次，我們正在針對這項重要資產執行強而有力的臨床計畫。在此投影片上，您可以看到精神分裂症方面未滿足的重大需求以及最近為 KarXT 提供的資料亮點。這些數據證明了其令人信服的長期療效，因為 KarXT 在所有療效指標中都與精神分裂症症狀的顯著改善有關，且沒有代謝或運動障礙副作用的證據。

This reinforces the very attractive profile for this medicine as an important advancement for patients and a significant commercial opportunity for the company. Underpinning our efforts to navigate this decade is an enhanced focus on driving operational productivity and efficiency, and we have made some notable progress already this year.

這增強了該藥物非常有吸引力的形象，作為對患者的重要進步和對公司的重要商業機會。我們對這十年的努力的支撐是更加重視提高營運生產力和效率，今年我們已經取得了一些顯著的進展。

Let's go to Slide 7. At a company level, we have clearly identified brands and programs that are most critical to both near and latter half of the decade performance. Across the organization, we have initiated efforts to delayer and streamline decision-making. And within R&D, we are optimizing the portfolio to focus our internal efforts on higher ROI programs. These are programs with compelling science, significant commercial value and in therapeutic categories where BMS is positioned and resourced to win. As a result of these actions, we anticipate cost savings of approximately $1.5 billion by the end of 2025, which will allow us to reinvest in high priority growth brands and R&D programs.

讓我們看幻燈片 7。在整個組織內，我們已開始努力推遲和簡化決策。在研發方面，我們正在優化產品組合，將內部工作重點放在更高投資報酬率的項目上。這些項目具有令人信服的科學性、顯著的商業價值，並且屬於百時美施貴寶的定位和資源足以獲勝的治療類別。透過這些行動，我們預計到 2025 年底將節省約 15 億美元的成本，這將使我們能夠對高優先成長品牌和研發項目進行再投資。

With our heightened focus on improving productivity and efficiencies, we're strengthening the company's long-term growth profile. This is a snapshot of what has been a very busy start to the year. And while we clearly have more work to do this year, we're off to a good start.

隨著我們更加重視提高生產力和效率，我們正在加強公司的長期成長前景。這是今年非常忙碌的開局的縮影。雖然今年我們顯然還有更多工作要做，但我們已經有了一個好的開始。

Let me close on Slide 8. Overall, our business outlook remains unchanged. We remain confident that we will deliver top line growth for the year consistent with what we communicated in February. And our underlying non-GAAP EPS forecast has also remained unchanged.

讓我以第 8 張投影片作為結束語。我們仍然有信心實現今年的營收成長，與我們 2 月傳達的內容一致。我們的基本非公認會計準則每股收益預測也維持不變。

We are taking important actions to effectively manage the decade. Our management team is focused on ensuring the disciplined execution required to deliver both this year and set us up for the longer term. I want to thank the employees of BMS, including new team members from our recent acquisitions for their contributions and commitment to delivering for patients.

我們正在採取重要行動來有效管理這十年。我們的管理團隊致力於確保今年實現目標並為我們的長期發展奠定基礎所需的嚴格執行。我要感謝 BMS 的員工，包括我們最近收購的新團隊成員，感謝他們為患者提供服務的貢獻和承諾。

Let me now hand it over to David. David?

現在讓我把它交給大衛。大衛？

Thank you, Chris, and good morning, everyone. As Chris highlighted, we're off to a good start to the year with top line growth as shown on Slide 10. As a reminder, unless otherwise stated, all comparisons are made from the same period in 2023 and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange.

謝謝你，克里斯，大家早安。正如克里斯所強調的那樣，我們今年有了一個良好的開端，營收成長如幻燈片 10 所示。基本基礎上進行的，排除了外匯的影響。

Building our momentum coming out of last year, we're executing against our plan to drive our growth portfolio, which delivered approximately 11% sales increase in the first quarter compared to the prior year and now represents approximately 40% of our total revenue. This growth was broad-based, with most growth brands recording significant increases in the quarter. Our legacy portfolio also contributed to overall sales growth in the quarter, with strong sales of Eliquis, which remains an important cash flow generator for the company.

憑藉去年的勢頭，我們正在執行推動成長投資組合的計劃，第一季銷售額比去年同期增長約 11%，目前約占我們總收入的 40%。這種成長是廣泛的，大多數成長品牌在本季度都錄得顯著成長。我們的傳統產品組合也為本季的整體銷售成長做出了貢獻，其中 Eliquis 的銷售強勁，它仍然是該公司重要的現金流發生器。

Now turning to the first quarter performance of our key brands, and starting with oncology on Slide 11. On this slide, you can see the impact of our strategy and broadening our I-O franchise and expanding in new targeted solid tumor therapies. Global sales of Opdivo were impacted by inventory work down and timing of orders in the U.S., partially offset by demand growth. As we said in the past, we expect to see growth at a more modest pace than 2024.

現在轉向我們主要品牌的第一季業績，從投影片11 上的腫瘤學開始。療法的影響。 Opdivo 的全球銷售受到庫存減少和美國訂單時間的影響，但部分被需求成長所抵消。正如我們過去所說，我們預計 2024 年的成長速度將更為溫和。

And Opdualag, a standard of care treatment in first-line melanoma, generated strong quarterly sales with U.S. sales growth primarily driven by strong market share. We are very encouraged by the future expansion potential of Opdualag, not only in adjuvant melanoma, but also in our plans to develop it in first-line lung cancer. This, along with the anticipated launch of our Opdivo subcutaneous formulation next year, we will extend our I-O franchise well into the next date. Our targeted solid tumor therapies expanded with the addition of Krazati after the completion of Mirati acquisition in late January.

Opdualag 是一線黑色素瘤護理治療標準，季度銷售額強勁，美國銷售額的成長主要是由強勁的市場份額推動的。我們對 Opdualag 未來的擴張潛力感到非常鼓舞，不僅是在輔助黑色素瘤領域，而且還計劃在一線肺癌領域開發它。加上我們預計明年推出的 Opdivo 皮下製劑，我們將把我們的 I-O 特許經營權延伸到下一個日期。一月下旬完成對 Mirati 的收購後，我們的標靶實體腫瘤治療隨著 Krazati 的加入而擴大。

Our reported sales represent a partial quarter. And on a pro forma basis, Krazati global sales in Q1 were approximately $27 million, primarily in the U.S. With recent conditional marketing approval by the European Commission, we look forward to bringing Krazati to more patients towards the end of the year. Augtyro's first quarter performance reflects positive early sales trends. We remain focused on driving awareness and penetration based upon its potential best-in-class profile.

我們報告的銷售額僅代表部分季度。根據預計，Krazati 第一季的全球銷售額約為 2,700 萬美元，主要是在美國。 Augtyro 第一季的業績反映了正面的早期銷售趨勢。我們仍然專注於根據其潛在的一流形象來提高認知度和滲透率。

Now moving to Slide 12 and our cardiovascular franchise. Eliquis remains the market-leading oral anticoagulant worldwide. Q1 sales in the U.S. grew 12%, primarily due to strong demand, including increased market share. Internationally, sales were roughly in line with prior year. Camzyos generated strong sales in the quarter, nearly tripling its performance versus Q1 of last year.

現在轉到幻燈片 12 和我們的心血管系列。 Eliquis 仍然是全球市場領先的口服抗凝血劑。美國第一季銷售額成長 12%，主要得益於強勁的需求，包括市場佔有率的增加。在國際上，銷售額與上年大致持平。 Camzyos 本季銷售額強勁，幾乎是去年第一季業績的三倍。

In the U.S., sales were driven by demand growth including an almost 25% increase in commercial dispenses since Q4 of 2023. Sequentially, U.S. sales of Camzyos were impacted by the inventory dynamics of approximately $20 million and gross to net impacts from the typical copay reset at the start of the new year. We expect the momentum of Camzyos to continue, supported by the compelling real-world evidence in over 1,500 patients presented earlier this month at ACC.

在美國，銷售受到需求成長的推動，包括自2023 年第四季以來商業配藥成長近25%。影響的影響在新年伊​​始。我們預計 Camzyos 的勢頭將繼續下去，並得到本月早些時候在 ACC 上展示的超過 1,500 名患者的令人信服的現實證據的支持。

Let's now turn to Slide 13 and discuss our hematology business. Our legacy brand, Revlimid, saw sales decline in the first quarter. Utilization of free drug program normalized in the quarter. We continue to anticipate variability in Revlimid sales quarter-to-quarter based upon historic dispensing patterns in specialty pharmacies. As anticipated, there is an increased volumes of U.S. generics starting in March.

現在讓我們轉向幻燈片 13，討論我們的血液學業務。我們的傳統品牌來那度胺 (Revlimid) 第一季​​度的銷售額有所下降。免費藥品計劃的使用在本季正常化。根據專業藥局的歷史配藥模式，我們繼續預測來那度胺銷售額的季度變化。正如預期的那樣，從三月開始，美國仿製藥的銷量有所增加。

Turning to Reblozyl, growth in the quarter was driven primarily by the strong U.S. launch of the broader commands label and first-line MDS. International sales growth benefited from the new market launches, and we look forward to bringing Reblozyl to more patients with the recent first-line approvals in the EU and Japan.

至於 Reblozyl，本季的成長主要是由於美國更廣泛的命令標籤和一線 MDS 的強勁推出所推動的。國際銷售的成長受益於新市場的推出，我們期待近期在歐盟和日本獲得一線批准的 Reblozyl 帶給更多患者。

In cell therapy portfolio, global Breyanzi sales growth reflected the strength of the clinical profile and improved manufacturing capacity. Consistent with what we previously communicated, starting in Q2, we expect Breyanzi to benefit from the recent new indications and expanded manufacturing capacity.

在細胞治療產品組合中，Breyanzi 的全球銷售額成長反映了臨床概況的實力和生產能力的提高。與我們之前傳達的訊息一致，從第二季開始，我們預計 Breyanzi 將從最近的新適應症和擴大的生產能力中受益。

With Abecma, U.S. performance in the quarter was impacted by ongoing competitive pressures. Future demand will benefit from the recent KarMMa-3 approval, which expands the addressable patient population. Internationally, Abecma demand growth was offset by unfavorable pricing pressures to secure access.

對於 Abecma，美國本季的業績受到持續競爭壓力的影響。未來的需求將受益於最近 KarMMa-3 的批准，該批准擴大了可尋址的患者群體。在國際上，Abecma 的需求成長被確保獲得准入的不利定價壓力所抵銷。

Now moving to immunology on Slide 14. Zeposia sales in the quarter were primarily due to demand of new patient starts in multiple sclerosis. SOTYKTU sales performed in line with our expectation. During the quarter, we delivered on our goal of achieving roughly 10,000 commercially paid prescriptions. Sales in the quarter reflected increased demand and expanded commercial access. In addition, we expect to add another large PBM later this year that will expand access coverage by approximately 30 million lives.

現在轉到幻燈片 14 上的免疫學。 SOTYKTU 的銷售表現符合我們的預期。本季度，我們實現了約 10,000 個商業付費處方的目標。本季的銷售反映了需求的增加和商業管道的擴大。此外，我們預計今年稍後將增加另一個大型 PBM，將覆蓋範圍擴大到約 3000 萬人。

Now turning to Slide 15. I will walk you through the remainder of our P&L, and my comments will be on a non-GAAP basis. As expected, gross margin decreased compared to the prior year, primarily due to product mix. Excluding acquired in-process R&D, first quarter operating expenses increased mainly due to the impact of the recent acquisitions and higher cost to support the overall portfolio. We expect this growth to be mitigated later in the year through savings and productivity initiatives I will speak to shortly.

現在轉向投影片 15。如預期，毛利率較上年下降，主要是由於產品組合所致。不包括收購的正在進行的研發，第一季營運費用增加主要是由於近期收購的影響以及支援整體產品組合的成本上升。我們預計，透過我稍後將談到的節約和生產力舉措，這種成長將在今年稍後得到緩解。

Other income and expense declined as expected in the first quarter, primarily due to lower PD-1 royalty rate and the financing costs associated with the recent transactions. Acquired in-process R&D in the quarter was $12.9 billion, primarily due to the previously disclosed onetime charge of $12.1 billion for the Karuna transaction and $800 million for SystImmune. Our tax rate in the quarter was impacted by the onetime nondeductible in-process R&D charge for Karuna.

第一季其他收入和支出如預期下降，主要是由於 PD-1 特許權使用費率下降以及與近期交易相關的融資成本。本季獲得的正在進行的研發費用為 129 億美元，主要是由於先前披露的 Karuna 交易一次性費用 121 億美元和 SystImmune 交易一次性費用 8 億美元。我們本季的稅率受到卡魯納一次不可扣除的研發費用的影響。

Before the impact of acquired in-process R&D, our first quarter earnings would have been $1.89. Taking into account the impact from the recent transactions, including acquired in-process R&D, we reported an earnings per share loss of $4.40.

在收購的正在進行的研發的影響之前，我們第一季的收益為 1.89 美元。考慮到近期交易（包括收購的正在進行的研發）的影響，我們報告每股收益虧損 4.40 美元。

Now moving to the balance sheet and capital allocation on Slide 16. Cash flow from operations remained strong with approximately $2.8 billion generated in the quarter, resulting in approximately $10 billion in cash and cash equivalents and marketable debt securities on hand as of March 31.

現在轉向幻燈片 16 上的資產負債表和資本配置。

Our strategic approach to capital allocation remains unchanged. We are committed to the dividend. And as we said previously, we plan to utilize our cash flow to repay approximately $10 billion of debt over the next 2 years. And we remain financially disciplined around business development to further strengthen the company's long-term growth profile.

我們的資本配置策略方針保持不變。我們致力於派發股息。正如我們之前所說，我們計劃在未來 2 年內利用現金流償還約 100 億美元的債務。我們在業務發展方面保持財務紀律，以進一步加強公司的長期成長前景。

Next, let's turn to Slide 17 to discuss our productivity initiative. As Chris described earlier, we have taken action to increase productivity and efficiency and focus our efforts on the assets and opportunities with the highest potential ROI and those most likely to drive our long-term growth. As part of this process, we are making deliberate choices to prioritize the assets that will have the greatest clinical benefit to impact areas of high unmet need and where we can deliver the most value for patients.

接下來，讓我們轉向投影片 17 來討論我們的生產力計畫。正如克里斯之前所描述的，我們已採取行動來提高生產力和效率，並將我們的努力集中在具有最高潛在投資回報率和最有可能推動我們長期成長的資產和機會上。作為這個過程的一部分，我們正在做出深思熟慮的選擇，優先考慮那些將具有最大臨床效益的資產，以影響高度未滿足需求的領域以及我們可以為患者提供最大價值的領域。

We will disproportionately invest in higher-return opportunities, which improves our portfolio ROI and strengthens our growth profile in the second half of the decade. After a thoughtful process, we have made the decision to discontinue and externalize several clinical assets. We anticipate cost savings from these actions of approximately $1.5 billion by the end of 2025, thereby absorbing the incremental OpEx expense from the recent deals. These cost savings will come from across the organization and include reductions in direct clinical expense, site rationalization and elimination of open roles and reduction in headcount. As we realize these savings, we will reinvest in the highest potential opportunities.

我們將不成比例地投資於高回報機會，這將提高我們的投資組合投資回報率並增強我們在本世紀後半葉的成長前景。經過深思熟慮的過程後，我們決定停止並外部化一些臨床資產。我們預計到 2025 年底，這些行動將節省約 15 億美元的成本，從而吸收最近交易中增加的營運支出。這些成本節約將來自整個組織，包括直接臨床費用的減少、場地合理化、空缺職位的消除以及員工人數的減少。當我們實現這些節省後，我們將再投資於最具潛力的機會。

Now turning to Slide 18. I'll walk through the impact of our recently closed acquisition on our EPS guidance. As you can see on this slide, if you take our previously stated non-GAAP EPS guidance range of $7.10 to $7.40 from February and include the previously stated impact of deal dilution and the onetime impact of acquired in-process R&D, our revised range continues to reflect the strong outlook of the business as we told you in February.

現在轉向幻燈片 18。正如您在這張幻燈片中看到的，如果您採用我們之前規定的2 月份的非GAAP 每股收益指導範圍7.10 美元至7.40 美元，並包括之前規定的交易稀釋的影響和收購的正在進行的研發的一次性影響，我們的修訂範圍繼續正如我們在二月份告訴您的那樣，以反映業務的強勁前景。

Now let's walk through the details of our guidance on Slide 19, starting with revenue. As is our practice, we provide revenue guidance on a reported basis as well as on an underlying basis, which assumes currency remains consistent with prior year. We continue to expect 2024 total revenues to increase in the low single-digit range at reported rates as well as excluding foreign exchange. This reflects our confidence in the growing momentum of our growth portfolio, including products such as Opdivo, Reblozyl, Breyanzi, Camzyos and SOTYKTU. And as a reminder, the sotatercept royalty will be included in the other growth revenue line.

現在讓我們從收入開始詳細介紹投影片 19 中的指導。按照我們的慣例，我們在報告的基礎上以及基礎基礎上提供收入指引，假設貨幣與上一年保持一致。我們繼續預期 2024 年總收入將在較低的個位數範圍內成長（以報告的成長率計算，不包括外匯）。這反映了我們對我們的成長組合的成長勢頭充滿信心，包括 Opdivo、Reblozyl、Breyanzi、Camzyos 和 SOTYKTU 等產品。提醒一下，sotatercept 特許權使用費將包含在其他成長收入線中。

We continue to expect gross margin to be approximately 74%. And as we saw last year, we should see a sequential dip in Q2 related to our sales mix. Excluding acquired in-process R&D, we continue to expect our total operating expenses to increase in the low single-digit range, reflecting incremental costs associated with the recent acquisitions, partially offset by the realization of internal savings through the productivity initiatives I mentioned earlier.

我們繼續預計毛利率約為 74%。正如我們去年所看到的，我們應該會看到第二季與我們的銷售組合相關的連續下降。不包括收購的正在進行的研發，我們繼續預計我們的總營運費用將在較低的個位數範圍內增加，這反映了與最近收購相關的增量成本，部分被我之前提到的生產力計劃實現的內部節省所抵消。

Given the timing of the deal closures, we expect to come in at the upper end of our guidance range with an expected step-up in Q2 and the remaining OpEx to be more evenly spread across the back half of the year. We remain aligned with our previous operating margin to target at least 37% through next year.

考慮到交易完成的時間，我們預計第二季的營運支出將達到指導範圍的上限，而剩餘的營運支出將更均勻地分佈在今年下半年。我們與先前的營業利潤率保持一致，目標是到明年至少達到 37%。

For OI&E, we now expect approximately $250 million of expense primarily reflecting the debt financing costs from Karuna and RayzeBio. The tax rate was affected by onetime nondeductible expense of the Karuna acquired and processed R&D charge, which impacted our non-GAAP net income. Excluding this impact, the estimated underlying tax rate in the quarter was about 19.5%. And as a result, we now see full year underlying tax rate of about 18%.

對於 OI&E，我們現在預計費用約為 2.5 億美元，主要反映了 Karuna 和 RayzeBio 的債務融資成本。稅率受到卡魯納收購和加工研發費用的一次性不可扣除費用的影響，這影響了我們的非公認會計準則淨利潤。剔除此影響，本季預計基礎稅率約為19.5%。因此，我們現在看到全年基本稅率約為 18%。

Before we move to Q&A, let me take a minute to read some of the key highlights on our call today. We grew the top line, we advanced the pipeline, and we are executing our productivity initiative and our expectations for the underlying strength of the business remains unchanged from the beginning of the year. Finally, I'd like to recognize our BMS employees around the world for their unwavering hard work and commitment as we continue to make progress in strengthening the company's long-term growth profile and bringing truly transformational medicines to patients.

在我們進行問答之前，讓我花一點時間閱讀我們今天電話會議的一些關鍵要點。我們增加了收入，我們推進了管道，我們正在執行我們的生產力計劃，我們對業務潛在實力的預期與年初相比保持不變。最後，我要表彰我們世界各地的 BMS 員工堅定不移的辛勤工作和奉獻精神，我們在加強公司的長期增長狀況和為患者提供真正變革性藥物方面不斷取得進展。

With that, I'll now turn the call over to Tim for Q&A.

現在，我將把電話轉給提姆進行問答。

Thanks, David. Can we go to the first question, please?

謝謝，大衛。我們可以回答第一個問題嗎？

(Operator Instructions) Our first question comes from Geoff Meacham with Bank of America.

（操作員說明）我們的第一個問題來自美國銀行的 Geoff Meacham。

Just had one for Chris or maybe for David. On the cost savings, how much would you say was legacy Bristol, either workforce or facilities versus optimizing integration of all your recent deals? I guess I'm trying to get a sense for whether you think there's further optimization to come as you guys focus on the new launch portfolio.

剛剛買了一份給克里斯或大衛。就成本節省而言，您認為傳統布里斯托爾（無論是勞動力還是設施）與優化整合您最近的所有交易相比節省了多少成本？我想我是想了解一下，當你們專注於新的發布產品組合時，是否認為還會有進一步的優化。

Jeff, I'll let David answer that.

傑夫，我會讓大衛回答這個問題。

Yes. Thanks, Jeff, for the question. The majority of the savings come from the historical BMS. As we talked about, the main drivers of the $1.5 billion savings really came into three buckets. First was really looking at the portfolio, obviously, with the Mirati, Karuna and with RayzeBio, we have really important portfolios that we're bringing into the overall portfolio. That gave us the opportunity to look at that and maximize the ROI of -- in totality of the portfolio as well as adjusting for some updates on new data and the competitiveness.

是的。謝謝傑夫提出問題。大部分節省來自歷史 BMS。正如我們所討論的，節省 15 億美元的主要驅動力實際上分為三個部分。首先是真正專注於產品組合，顯然，透過 Mirati、Karuna 和 RayzeBio，我們擁有非常重要的產品組合，我們正在將其納入整體產品組合中。這使我們有機會審視這一點，並最大限度地提高整個投資組合的投資回報率，並根據新數據和競爭力的一些更新進行調整。

The second thing that we really looked at for legacy BMS is how do we become more agile, quicker decision-making and streamline the organization by removing layers of management so decisions can be more quickly. And there, we talked about the roughly 2,200 impacted employees as a result of those changes.

對於遺留 BMS，我們真正關注的第二件事是如何變得更敏捷、更快地制定決策，並透過消除管理階層來簡化組織，從而更快地做出決策。在那裡，我們討論了因這些變化而受到影響的約 2,200 名員工。

And then lastly, we went through all of our third-party relationships, continuing to look for efficiencies in third-party service providers, and that was the last category. And a lot of those activities are also legacy BMS. So the vast majority of the savings are coming from our in-house existing operations.

最後，我們檢查了所有第三方關係，繼續尋找第三方服務提供者的效率，這是最後一類。其中許多活動也是傳統的 BMS。因此，絕大多數節省都來自我們內部的現有營運。

Our next question comes from Chris Shibutani with Goldman Sachs.

我們的下一個問題來自高盛的 Chris Shibutani。

Obviously, a lot of moving parts operationally, strategically. I think investors have been keen to get a sense for how you're thinking about potentially a trough level of earnings. I think the notion that there might be some visibility into where you could begin to see some growth, and I know in your vocabulary, you mused about exiting the decade and into the next. Help us with where you are with that thinking since we haven't had that clarity with all the moving parts. But how are you thinking about the potential to communicate that kind of timeline and model?

顯然，在操作和戰略上有很多變化。我認為投資者一直渴望了解您如何看待潛在的獲利低谷水平。我認為，你可能會在哪裡開始看到一些成長，而且我知道在你的詞彙中，你思考過如何退出這個十年並進入下一個十年。請幫助我們了解您的想法，因為我們對所有活動部件還沒有那麼清晰。但您如何看待傳達這種時間表和模型的潛力？

Okay. Chris, I'll take that one. And I think there, embedded in that question, maybe two things. First is how we're thinking about how we're going to guide around this trough and then there's maybe a second question in there, which is when we think we'll see that trough and what's the timing of it.

好的。克里斯，我要那個。我認為，在這個問題中，也許有兩件事。首先是我們如何思考如何引導這個低谷，然後可能還有第二個問題，就是我們認為什麼時候會看到這個低谷以及它出現的時間是什麼。

With respect to the first question, look, we've been engaging with investors on this topic over the last number of months. A bit of context here, given the industry dynamics, we -- certainly, I believe companies in this industry need to be judicious with respect to providing long-term guidance. But we get why you are asking the question here, because it's something that we're going to need to continue to engage with investors on to strike the right balance in terms of how we think about providing guidance on this topic.

關於第一個問題，過去幾個月我們一直在與投資者就這個主題進行接觸。這裡有一些背景信息，考慮到行業動態，我們——當然，我相信這個行業的公司需要明智地提供長期指導。但我們明白你為什麼在這裡問這個問題，因為我們需要繼續與投資者接觸，以便在我們如何考慮就此主題提供指導方面取得適當的平衡。

One uncertainty that we know that's related to this question, though, is the impact of IRA on Eliquis. And once that price is public, and remember, that's going to happen in the September time frame, we'll provide the impact of Eliquis both on the top line as well as on EPS.

不過，我們知道與這個問題相關的一個不確定性是 IRA 對 Eliquis 的影響。一旦該價格公開，請記住，這將在 9 月的時間範圍內發生，我們將提供 Eliquis 對營收和每股盈餘的影響。

In terms of how we think about the timing of the trough, based on our current plans, we start to see an impact in 2026. And then as we said earlier in the year, we anticipate to be returning to growth before the end of the decade. And then obviously, we're clearly focused on accelerating both the timing and the pace of growth in the back half of the decade, and that's going to influence timing as well.

就我們如何看待谷底出現的時間而言，根據我們目前的計劃，我們將在 2026 年開始看到影響。年。顯然，我們顯然專注於加快本世紀後半葉的成長時機和速度，這也會影響時機。

Our next question comes from Chris Schott with JPMorgan.

我們的下一個問題來自摩根大通的克里斯·肖特。

Just a two-parter, coming back to the restructuring. I guess the first part is, is the redeployment of savings going to be mostly focused on the R&D side or on SG&A? And just related to that, in terms of investment in the growth drivers, it seems like elements such as payer dynamics and competitive launches are impacting uptake of some of the new launch assets. So I'm just interested in which products do you see having the greatest potential for improvement with further investment, and how you, I guess, balanced SG&A versus either further R&D or just dropping some of those savings to the bottom line as you're considering kind of how to redeploy that $1.5 billion.

只是兩個人，回到重組。我想第一部分是，儲蓄的重新​​部署將主要集中在研發方面還是SG&A 方面？與此相關的是，就成長驅動力的投資而言，付款人動態和競爭性發布等因素似乎正在影響一些新發布資產的吸收。因此，我只是感興趣的是，您認為哪些產品透過進一步投資具有最大的改進潛力，以及我猜您如何平衡 SG&A 與進一步的研發，或者只是將其中一些節省的費用降到底線。這15 億美元。

Thanks, Chris. Let me just say a couple of words and then I'll turn it over to David for the first part of your question, then Adam can come in on the back end. First, as David mentioned, when we thought about these efficiencies, we were really thinking along three lines: the need to invest in the pipeline; ensuring that we had adequate investment for our growth products; and then needing to be more agile and focused as an organization. In terms of how we think about allocating those redeployment opportunities, I would say, generally speaking, they're in that order with the majority going back into R&D.

謝謝，克里斯。讓我簡單說幾句話，然後我將把你問題的第一部分轉交給大衛，然後亞當可以在後端介入。首先，正如大衛所提到的，當我們考慮這些效率時，我們實際上是沿著三個思路思考的：需要投資管道；確保我們對成長型產品有足夠的投資；然後作為一個組織需要更加敏捷和專注。就我們如何考慮分配這些重新部署機會而言，我想說，一般來說，它們是按這個順序排列的，其中大多數回到了研發領域。

But David, do you want to start?

但是大衛，你想開始嗎？

And yes, Chris, thanks for the question. The way to think about it, about 2/3 of the savings associated in the R&D area and about 1/3 is in MS&A. But importantly, if you really think about the acquisitions that we've just done, if you think about Mirati and Krazati, in particular, really important development programs in first-line lung, both the doublet as well as the triplet.

是的，克里斯，謝謝你的提問。想想看，大約 2/3 的節省與研發領域相關，大約 1/3 則用於管理與分析。但重要的是，如果你真正考慮我們剛剛完成的收購，如果你考慮 Mirati 和 Krazati，特別是一線肺部非常重要的開發項目，無論是雙聯體還是三聯體。

And then if you think about Karuna, and Adam can talk further about this, we see multiple indications -- billion-dollar indications in this space. We talked about schizophrenia, the adjuvant schizophrenia as well is moving into Alzheimer's with agitation and psychosis. So there's significant investments that you have to make there.

然後，如果你想到卡魯納，亞當可以進一步討論這一點，我們會看到多種跡象——這個領域價值數十億美元的跡象。我們談到了精神分裂症，輔助性精神分裂症也正在發展為伴隨煩躁和精神病的阿茲海默症。因此，您必須在那裡進行大量投資。

And then if you think about radioligand and RayzeBio, we see multiple INDs being able to come out of this. We're also -- we finished the manufacturing facility in Indianapolis. We're going to be able to supply our clinical studies out of that. So significant investments in those three areas, which through all of that as well as reprioritizing our existing BMS portfolio, what we've been able to do is increase the ROI of the portfolio. But just as importantly, we increased the growth profile of the company in the second half of the decade.

然後，如果您考慮放射性配體和 RayzeBio，我們會看到多個 IND 能夠從中產生。我們也——我們完成了印第安納波利斯的製造工廠。我們將能夠從中提供我們的臨床研究。在這三個領域進行了大量投資，透過所有這些以及重新調整我們現有的 BMS 產品組合的優先順序，我們能夠做的是提高產品組合的投資回報率。但同樣重要的是，我們在這十年的後半段提高了公司的成長前景。

So there's a lot of work that's going under the surface in order to continue to maximize the value of the portfolio and strengthen the growth profile of the company. Adam?

因此，為了繼續最大化投資組合的價值並加強公司的成長前景，還有很多工作正在進行。亞當？

Yes. Chris, thanks for the question. So we're making good progress across the totality of our growth portfolio. As David shared, we saw strong year-on-year demand growth across the majority of our growth products. And we continue to be focused on accelerating our key brands. And we're doing what we said we would do as we continue to drive our growth portfolio.

是的。克里斯，謝謝你的提問。因此，我們的整個成長投資組合都取得了良好進展。正如大衛分享的那樣，我們看到大多數成長型產品的需求較去年同期強勁成長。我們將繼續專注於加速我們的關鍵品牌的發展。我們正在按照我們所說的去做，並繼續推動我們的成長投資組合。

So just a few of the products that I think is important to mention. Opdualag has become a new standard of care in first-line metastatic melanoma, grew 76%. Reblozyl continue to deliver strong performance post first-line. COMMANDS approval grew over 70% as well.

因此，僅介紹一些我認為值得一提的產品。 Opdualag 已成為一線轉移性黑色素瘤的新照護標準，成長了 76%。 Reblozyl 在一線後繼續表現強勁。 COMMANDS 的核准率也成長了 70% 以上。

We have increased investment at the end of last year behind products like SOTYKTU, Breyanzi and Camzyos. Camzyos continues to demonstrate strong growth. We had 25% growth of new patients added on to commercial drug quarter-over-quarter. Breyanzi, we also increased our investment. We're a much stronger supply position today than we were last year and increasingly being recognized as a best-in-class CAR-T. And as David mentioned, we're readying for the launch of KarXT in September, which is a very significant multibillion-dollar opportunity.

去年年底，我們增加了對 SOTYKTU、Breyanzi 和 Camzyos 等產品的投資。 Camzyos 繼續展現出強勁的成長勢頭。與商業藥物相比，我們的新患者數量較上季增加了 25%。 Breyanzi，我們也增加了投資。今天，我們的供應狀況比去年要強大得多，並且越來越被認為是一流的 CAR-T。正如 David 所提到的，我們正準備在 9 月推出 KarXT，這是一個非常重要的數十億美元的機會。

I would say that a product like Abecma has been more challenging for us. But we have an opportunity now with the KarMMa-3 approval to work to return Abecma to growth over time as we move into a larger patient population. But adding it all up, we continue to make good progress in delivering strong commercial execution and performance.

我想說像 Abecma 這樣的產品對我們來說更具挑戰性。但隨著 KarMMa-3 的批准，我們現在有機會隨著時間的推移，隨著我們進入更大的患者群體，使 Abecma 恢復增長。但總而言之，我們在提供強大的商業執行力和業績方面繼續取得良好進展。

Our next question comes from Evan Seigerman with BMO.

我們的下一個問題來自 BMO 的 Evan Seigerman。

Kind of a follow-up to what we've been talking about. So when you talk about the cost savings being reinvested, do you mean that you're going to manage your margins by titrating the reinvestment of the cost savings? Are you going to deploy the $1.5 billion kind of informed by the science or potential for growth?

這是我們一直在討論的內容的後續。因此，當您談論節省的成本進行再投資時，您的意思是說您將透過滴定成本節省的再投資來管理利潤嗎？您打算根據科學或成長潛力來部署這 15 億美元嗎？

And then a follow-up, as you mentioned you're going to discontinue and externalize several clinical assets. Any commentary as to which ones you're thinking about? That would be great.

然後是後續行動，正如您所提到的，您將停止並外部化一些臨床資產。對於您正在考慮哪些，有什麼評論嗎？那太好了。

Thanks, Evan. We'll have David start, and then Samit.

謝謝，埃文。我們將由大衛首發，然後是薩米特。

Yes. Thank you, Evan. As I said in my prepared remarks, we're looking at our operating margins as we previously communicated in that 37% range. So that $1.5 billion of savings that we'll achieve by the end of next year, that's being reinvested both in the portfolio as I described earlier, particularly with the acquisitions that we did. But we've also had good progress like Opdualag lung where we're going to continue those clinical studies as well. And all of that put together, as I was saying, really strengthens not only the ROI, but the growth profile of the business in the second half of the decade. And I'll turn it over to Samit on the assets that we're looking at to externalize.

是的。謝謝你，埃文。正如我在準備好的演講中所說，我們正在考慮我們之前溝通的 37% 範圍內的營業利潤率。因此，到明年年底，我們將節省 15 億美元，這些資金將被重新投資到我之前描述的投資組合中，特別是我們所做的收購。但我們也取得了良好的進展，例如 Opdualag 肺，我們也將繼續進行這些臨床研究。正如我所說，所有這些加在一起不僅確實增強了投資回報率，而且還增強了本世紀後半葉業務的成長前景。我將把我們正在考慮外部化的資產交給 Samit。

Yes. Thank you, David. And just to build on what David said, from a pipeline perspective, we took a very thoughtful approach to see -- from our rich pipeline, what are the assets that we are not going to be continuing on our own. So first thing that we looked at is the evolving science from the ongoing exploration of our clinical assets. An example over there where we look at CTLA-4 in our pipeline that we were developing, we had set the bar with ipilimumab, which is already a high bar to then look at the data and then we decided that if the data are not going to be better than ipilimumab, we shouldn't be continuing that program, so we decided not to continue with that.

是的。謝謝你，大衛。在大衛所說的基礎上，從管道的角度來看，我們採取了一種非常深思熟慮的方法，從我們豐富的管道中，看看哪些資產是我們不會繼續自己繼續的。因此，我們首先關注的是從我們的臨床資產不斷探索中不斷發展的科學。那邊的一個例子，我們在我們正在開發的管道中查看 CTLA-4，我們用 ipilimumab 設定了標準，這已經是一個很高的標準，然後查看數據，然後我們決定，如果數據沒有繼續下去為了比ipilimumab 更好，我們不應該繼續該計劃，因此我們決定不再繼續該計劃。

Similarly, when we looked at external and internal data for the SIRP alpha program, that did not meet the muster, and we wanted to look at the real return on that investment as well for patients. And so we are not going to continue that program.

同樣，當我們查看 SIRP alpha 計劃的外部和內部數據時，發現它不符合要求，我們也想看看該投資對患者的實際回報。因此我們不會繼續該計劃。

The second way we looked at it is that the science may be really good. Data evolution is really good, but does it really make sense from -- for a company our size to continue a program if it's not going to be ultimately a growth driver. So from that perspective, if you think about BET 158, where the data are pretty good in myelofibrosis, but really, from our perspective, does not meet the threshold to be a driver for our growth potential. So that program, we are not going to be continuing.

我們看待這個問題的第二種方式是，科學可能真的很好。資料進化確實很好，但對於像我們這樣規模的公司來說，如果它最終不能成為成長動力，那麼它真的有意義嗎？因此，從這個角度來看，如果您考慮 BET 158，其中在骨髓纖維化方面的數據相當不錯，但實際上，從我們的角度來看，它並沒有達到成為我們成長潛力驅動因素的門檻。因此，我們不會繼續該計劃。

And then, of course, we continue to look at our desire to be either first-in-class or best-in-class product profile. So from that perspective, we continue to focus on what we will continue versus not. Overall, I would say, Evan, that we have about -- discontinued about 12 programs at this time. But it's a continuum. And so throughout the year, we'll continue to look at these same principles and see what else we need to take out from our pipeline and either externalize it or not be able to develop it further.

當然，我們會繼續關注我們的願望，即成為一流或一流的產品。因此，從這個角度來看，我們將繼續關注我們將繼續做什麼，而不是繼續做什麼。總的來說，Evan，我想說，我們目前已經停止了大約 12 個項目。但這是一個連續體。因此，在這一年中，我們將繼續研究這些相同的原則，看看我們還需要從我們的管道中取出什麼，要么將其外部化，要么無法進一步開發它。

Our next question comes from Seamus Fernandez with Guggenheim Securities.

我們的下一個問題來自古根漢證券公司的謝默斯·費爾南德斯。

So just wanted to check in on your thoughts around IRA and the impacts associated with that as we approach 2026 in particular. And if you might be able to provide us any color on progress or process in the "negotiations" or price fixing that may come from the U.S. government.

因此，我只是想了解一下您對 IRA 的看法，以及在我們接近 2026 年之際與之相關的影響。您能否向我們提供有關美國政府可能進行的「談判」或價格固定的進展或過程的任何資訊。

And then just the second question, hoping you might comment, help frame for us the Opdualag opportunity in lung cancer and when we might gain some incremental visibility on that. Is it going to be more from clinical trials hitting clinicaltrials.gov, and we'll get some information in that regard first? Or will we actually see the data in this potential subset?

然後是第二個問題，希望您能發表評論，幫助我們建立 Opdualag 在肺癌中的機會，以及我們何時可以對此獲得一些增量的了解。是否會更多來自於 ClinicalTrials.gov 上的臨床試驗，我們會先獲得這方面的一些資訊？或者我們真的會看到這個潛在子集中的數據嗎？

Thanks for the question, Seamus. Maybe I'll start, have Adam weigh in a little bit more on IRA. With respect to the ongoing discussions with CMS, we're not going to be commenting. As I said earlier, we will have the outcome of that public in September and we'll be able to provide more insight at that point. But Adam, you can speak to some of the other aspects of IRA and then Samit.

謝謝你的提問，西莫。也許我會開始讓 Adam 對 IRA 進行更多的權衡。對於與 CMS 正在進行的討論，我們不會發表評論。正如我之前所說，我們將在 9 月得到公眾的結果，屆時我們將能夠提供更多見解。但是 Adam，你可以談談 IRA 的其他一些方面，然後是 Samit。

Yes. Thank you, Chris and Seamus, thanks for the question. As it relates to IRA, there are obviously multiple components to it. There's the negotiation. There's also the change in the Part D benefit design. So in 2024, we don't anticipate significant impact across our portfolio, across Eliquis, Revlimid or other brands. We do expect, though, more substantial changes to the Part D benefit next year since the products are impacted by the redesign. We are carefully evaluating each product individual dynamics now and we'll see into the future. And we're monitoring very closely to understand the impact of, for example, out-of-pocket caps and other shifts that are happening in the system.

是的。謝謝克里斯和西莫，謝謝你們的提問。由於它與 IRA 相關，因此顯然有多個組成部分。那裡有談判。 D 部分的福利設計也改變了。因此，到 2024 年，我們預計我們的產品組合、Eliquis、Revlimid 或其他品牌不會受到重大影響。不過，由於產品受到重新設計的影響，我們確實預期明年 D 部分的好處會發生更實質的變化。我們現在正在仔細評估每個產品的個體動態，並展望未來。我們正在非常密切地監控，以了解自付費用上限和系統中發生的其他變化等的影響。

So as we move from a $3,500 cap to a $2,000 cap, we would expect to see more patients' ability to fill their medicines and improve as it becomes lower at the pharmacy counter. But obviously, we'll need to do more -- see more data before we can provide additional details.

因此，當我們從 3,500 美元上限提高到 2,000 美元上限時，我們預計會看到更多患者配藥的能力，並隨著藥房櫃檯價格的降低而有所改善。但顯然，我們需要做更多的事情——查看更多數據，然後才能提供更多詳細資訊。

Thank you, Adam. And then thanks, Seamus, for the question. For Opdualag, let's just take a step back and understand what we were planning to do and try to do. So for Opdualag, we conducted a study of Opdualag plus chemotherapy in first-line non-small cell lung cancer. At first, we wanted to define the dose. So we tested a couple of doses in the first part of the study. And in the second part of the study, then we randomize the patient to receive Opdualag plus chemotherapy versus nivolumab plus chemotherapy.

謝謝你，亞當。然後謝謝謝莫斯提出的問題。對於 Opdualag，讓我們退後一步，了解我們計劃做什麼和嘗試做什麼。所以對於Opdualag，我們進行了Opdualag合併化療一線非小細胞肺癌的研究。起初，我們想定義劑量。因此，我們在研究的第一部分測試了幾個劑量。在研究的第二部分中，我們將患者隨機分配接受 Opdualag 加化療與納武單抗加化療。

And as we have said before, what we wanted to understand, is the drug applicable for all patients? Or are we going to find a differential activity in a subset of patients? And what we have said is we have found a subgroup of patients where the drug's activity is good and encourages us to now go into a Phase III trial. And so we are looking forward to presenting the data in the second half of this year as well as initiating the trial versus standard of care in the second half of this year. And we are planning that, we'll be executing that. As soon as we have that ready, you will be hearing about it.

正如我們之前所說，我們想了解的是，該藥物是否適用於所有患者？或者我們會在一部分患者中發現不同的活動？我們所說的是，我們已經發現了一個藥物活性良好的患者亞群，這鼓勵我們現在進入 III 期試驗。因此，我們期待在今年下半年提供數據，並在今年下半年啟動與標準護理相比的試驗。我們正在計劃，我們將執行。一旦我們準備好，您就會聽到。

In addition to that, Opdualag, is of course, other opportunities. As you know, we are already waiting for the data for the adjuvant melanoma trial and we're looking forward to the data evolution towards the back end of this year in first-line hepatocellular carcinoma as well.

除此之外，Opdualag，當然還有其他機會。如您所知，我們已經在等待黑色素瘤輔助試驗的數據，我們也期待今年年底一線肝細胞癌的數據進展。

Our next question comes from Terence Flynn with Morgan Stanley.

我們的下一個問題來自摩根士丹利的特倫斯·弗林。

Maybe a two-part for me on the CAR-T franchise. David, I think you mentioned something about Abecma ex-U.S. pricing dynamics, some change there to help boost access. Can you just provide a little bit more detail if that was a one-off in a specific country or what's going on there?

對我來說，CAR-T 特許經營權可能分為兩部分。 David，我想你提到了一些關於 Abecma（美國除外）的事情。定價動態方面，有一些變化有助於提高訪問量。如果這是在某個特定國家/地區發生的一次性事件或那裡發生了什麼，您能否提供更多詳細資訊？

And then on Breyanzi, Gilead has talked more recently about moving in the U.S. out to some of these secondary community hospitals as they think about expanding, particularly in the second-line label indication. And so is that something that you guys are considering as well? Or do you feel pretty good about your current footprint for Breyanzi at the primary academic hospitals?

然後，在 Breyanzi 上，吉利德最近談到了將業務轉移到美國的一些二級社區醫院，因為他們正在考慮擴張，特別是在二線標籤適應症方面。你們也在考慮這件事嗎？或者您對 Breyanzi 目前在初級學術醫院的足跡感到滿意嗎？

Thanks, Terence. I'll let Adam take both of those.

謝謝，特倫斯。我會讓亞當拿走這兩個。

So as it relates to Breyanzi, what we saw in the quarter was we were able to stabilize the decline in the U.S. Sales were roughly flat versus last quarter. What you're referring to internationally is we did see strong demand growth, which we expect to continue, but that demand growth was offset by negative pricing skewing reimbursement, mainly in Germany. So that's where that took place.

因此，就 Breyanzi 而言，我們在本季看到的是，我們能夠穩定美國銷售額的下降趨勢，與上季基本持平。您指的是國際上我們確實看到了強勁的需求成長，我們預計這種成長將持續下去，但需求成長被負定價傾斜補償所抵消，主要是在德國。這就是事情發生的地方。

And now with KarMMa-3, it gives us the opportunity to have a different conversation with our customers about our data in a larger patient population. And our objective is to return Abecma to growth over time as we move into this larger patient population.

現在，借助 KarMMa-3，我們有機會與客戶就更多患者群體中的數據進行不同的對話。我們的目標是隨著我們進入更大的患者群體，讓 Abecma 隨著時間的推移恢復成長。

Now for Breyanzi, we're very excited about this product. In Q1, we increased sales over 50% versus the prior year. We anticipate robust growth this year, because not only just in accelerated growth in DLBCL, as Breyanzi is increasingly recognized as the best-in-class CD19, we also expect to see expanded indications. We just received approval in the U.S. for CLL and with additional approvals anticipated next month in follicular lymphoma and mantle cell lymphoma. And this is going to roughly double the addressable market for Breyanzi.

現在，對於 Breyanzi 來說，我們對這款產品感到非常興奮。第一季度，我們的銷售額比去年同期成長了 50% 以上。我們預計今年將出現強勁成長，因為隨著 Breyanzi 越來越被認為是同類最佳 CD19，不僅在 DLBCL 方面加速成長，我們預計會看到擴大的適應症。我們剛剛在美國獲得了針對 CLL 的批准，預計下個月還將獲得針對濾泡性淋巴瘤和套細胞淋巴瘤的額外批准。這將使 Breyanzi 的潛在市場增加一倍。

We're also very encouraged by our expanded manufacturing capacity and now in a much stronger position to meet demand. We're seeing about 20% outpatient use today for Breyanzi, and we expect that to continue based on the differentiated safety profile. So taken together, we're very excited about the growth profile of Breyanzi.

我們擴大的製造能力也讓我們深受鼓舞，現在我們在滿足需求方面處於更有利的地位。今天，我們看到大約 20% 的門診患者使用 Breyanzi，並且我們預計基於差異化的安全性，這一情況將繼續下去。綜上所述，我們對 Breyanzi 的成長狀況感到非常興奮。

Our next question comes from Tim Anderson at Wolfe Research.

我們的下一個問題來自沃爾夫研究中心的蒂姆·安德森。

This is Adam on for Tim at Wolfe Research. So just on SOTYKTU, can you give us some updated market share metrics, things like new-to-brand share or versus Otezla in the oral category percent use in first-line versus later lines, that sort of thing? And also, any details on when the free drug program might begin to wind down?

我是沃爾夫研究中心的亞當 (Adam) 替提姆 (Tim) 發言。那麼，就 SOTYKTU 而言，您能否給我們一些更新的市場份額指標，例如新品牌份額或與 Otezla 在口服類別中一線與後線的使用百分比之類的事情？另外，關於免費藥品計劃何時開始結束的任何細節？

Sure. I'll take that, Adam. Thanks for the question. So we're continuing to make progress with SOTYKTU, and we're executing our plan. We delivered in the quarter what we said we would do, and that's reaching approximately 10,000 paid prescriptions. That's what we shared in January, and we expect to roughly double that to 20,000 paid prescriptions in Q4. So that's where we're focused on driving today.

當然。我會接受的，亞當。謝謝你的提問。因此，我們將繼續與 SOTYKTU 取得進展，並且正在執行我們的計劃。我們在本季度兌現了承諾，付費處方數量已達到約 10,000 份。這就是我們 1 月分享的內容，我們預計第四季度的付費處方數量將增加一倍，達到 20,000 個。這就是我們今天要重點討論的地方。

Remember, we also said there would be an increase in gross to net due to broader rebating needed to secure improved access, and this impacted sales in Q1. But the volume that we'll see will more than offset that throughout the year. So we talked about improving our access position. And aside from the wins that we announced last year in CVS and Cigna and ESI, we saw access improvement with SOTYKTU, which was added to Optum. And as David mentioned, we do expect to announce additional improved formulary access including a large PBM with approximately 30 million lives.

請記住，我們還表示，由於需要更廣泛的回扣來確保改善訪問，因此毛淨值將會增加，這影響了第一季的銷售。但我們將看到的銷量將足以抵消全年的影響。所以我們討論了改善我們的訪問位置。除了我們去年在 CVS、Cigna 和 ESI 中宣布的勝利之外，我們還看到了 SOTYKTU 的訪問改進，它已添加到 Optum 中。正如 David 所提到的，我們確實希望宣布進一步改進的處方取得方式，包括涉及約 3000 萬人的大型 PBM。

So we remain focused on securing zero steps by 2025. And when you have that better access position, the need for a bridge becomes less and less important. And so basically, when you look at -- when you have better access, patients are moved faster into commercial product because they go directly to the specialty pharmacy.

因此，我們仍然致力於在 2025 年確保零台階。所以基本上，當你有更好的機會時，患者會更快進入商業產品，因為他們直接去專業藥局。

As far as market share, look, this is a highly competitive market. We look at launch analogs at the top of the funnel or written prescriptions, and SOTYKTU performance is ahead of products like TREMFYA, COSENTYX at the same time ago launch. We are laser focused on share growth versus Otezla, which is a critical area of focus and becoming the oral standard of care in the market over time.

就市場佔有率來看，這是一個競爭激烈的市場。我們查看了漏斗頂部的類似產品或書面處方，SOTYKTU 的性能領先於同時上市的 TREMFYA、COSENTYX 等產品。我們專注於與 Otezla 相比的份額增長，這是一個關鍵的關注領域，並隨著時間的推移成為市場上的口腔護理標準。

Our next question comes from Dave Risinger with Leerink Partners.

我們的下一個問題來自 Leerink Partners 的 Dave Risinger。

And thanks for all of the detailed perspectives that you're sharing. So I'm hoping that you can help with other income prospects in the future, including the look for AstraZeneca, other incomes, run rate and the anticipated step down in coming years.

感謝您分享的所有詳細觀點。因此，我希望您能在未來的其他收入前景方面提供協助，包括尋找阿斯特捷利康、其他收入、運行率以及未來幾年的預期降級。

Thanks, Dave. David?

謝謝，戴夫。大衛？

Yes. So this year was the big step down in the PD-1 rate. And then the other thing impacting that is the diabetes that will step down next year as well.

是的。因此，今年 PD-1 率大幅下降。另一個影響這一點的因素是明年糖尿病也將消失。

The other thing to keep in mind, as I said in the prepared remarks is on the interest for the additional debt that we just did. That was the big change in the guidance that we just provided for this year, going from $250 million of OI&E income down to $250 million of expense. And the bulk of that is related to the additional interest cost, which is around $13 billion with 5.3% interest rate. And that's slightly offset by the royalty income.

正如我在準備好的演講中所說，另一件事要記住的是我們剛剛所做的額外債務的利息。這是我們剛剛為今年提供的指導的重大變化，從 2.5 億美元的 OI&E 收入降至 2.5 億美元的支出。其中大部分與額外利息成本有關，以 5.3% 的利率計，該成本約為 130 億美元。這被特許權使用費收入稍微抵消了。

And our next question comes from Mohit Bansal with Wells Fargo.

我們的下一個問題來自富國銀行的 Mohit Bansal。

I actually want to probe the trough guidance comment a little bit further. It does seem like that you are considering it. But if that is the case, can you talk a little bit about the puts and takes there regarding timing of such guidance? I'm asking because it depends on when you think the trough is, if it is '26 or '28. Because, I mean, you might not want to provide if it is '28, but just now because it is still a little bit uncertain regarding the timing of it. So what are the puts and takes regarding the timing of it when you eventually decide to provide it?

我其實想進一步探討谷底指導評論。看起來你確實正在考慮它。但如果是這樣的話，您能否談談有關此類指導的時機的看跌期權和看跌期權？我這麼問是因為這取決於你認為低潮是什麼時候，是 26 年還是 28 年。因為，我的意思是，你可能不想提供是否是 28 年的信息，但只是現在，因為它的時間安排仍然有點不確定。那麼，當您最終決定提供它時，關於它的時間安排有哪些呢？

Yes. So maybe I'll start and then David can chime in if he has any additional -- anything else that he would like to provide. I think the way we're thinking about the trough guidance, and again, it's something that we have been engaged with investors for the last number of months. I think the way I would think about it is, first and foremost, probably the underlying question on guidance right now is what is the impact of IRA on Eliquis. We will, as I said earlier, be in a position in September when the price for Eliquis coming out of the IRA process is known and public, at that point, to talk about what that price is and the impact of -- on Eliquis on both the top line as well as on EPS.

是的。所以也許我會開始，然後大衛可以插話，如果他有任何額外的東西——任何他想提供的東西。我認為我們思考谷底指導的方式，也是我們過去幾個月與投資人接觸的事情。我認為我的思考方式是，首先也是最重要的，目前指導的根本問題可能是 IRA 對 Eliquis 的影響是什麼。正如我之前所說，我們將在 9 月份，當 IRA 流程中的 Eliquis 價格已知並公開時，我們將討論該價格以及對 Eliquis 的影響營收和每股收益。

And then in terms of how we're thinking about the timing of the trough, again, and we said this back at the beginning of the year, we see the impact starting in 2026 and our plan is to be growing by the end of this decade. David, anything else you would add?

然後，就我們如何考慮谷底出現的時間而言，我們在今年年初就說過，我們認為影響將從 2026 年開始，我們的計劃是到今年年底擴大影響。大衛，你還有什麼要補充的嗎？

I think you covered it, Chris.

我想你已經涵蓋了，克里斯。

Our next question is from Carter Gould with Barclays.

我們的下一個問題來自巴克萊銀行的卡特·古爾德。

I wanted to dig into Camzyos for a second. You did have data at ACC and sort of the current rate or the one with that seemed very positive. And just when you think about that REMS registry data and the potential to potentially get the REMS modified down the road, should we be reading into that data? Any level of confidence or anything on that front you want to message?

我想深入研究一下 Camzyos。你確實有 ACC 的數據，目前的利率或看起來非常積極的利率。當您考慮 REMS 註冊表資料以及 REMS 未來修改的可能性時，我們是否應該讀取這些資料？您有什麼信心程度或在這方面有什麼想要傳達的訊息嗎？

And I guess along those lines as well just, I believe housekeeping on -- did I hear a $20 million inventory impact in the quarter? I know that something was called on the slides, but I'm not sure that was quantified. Any help there would be great, too.

我想沿著這些思路，我相信內務管理工作仍在繼續——我是否聽說本季庫存受到了 2000 萬美元的影響？我知道幻燈片上提到了一些東西，但我不確定這是否被量化。任何幫助也會很棒。

Yes. Thanks, Carter. Maybe Samit can start and then Adam. .

是的。謝謝，卡特。也許薩米特可以先發，然後是亞當。 。

Yes. Thank you, Carter, for the question. So for Camzyos, we remain obviously very confident in the overall profile of Camzyos. It has been a very transformational therapy for patients. And as you mentioned, the data at ACC clearly showed from the patients that have been treated in the real world that there is transformational outcome. And from a safety perspective, with 80% of the patients being treated, the 2.5- and the 5-milligram dose, the overall outcomes remain really, really positive as well as the impact on the ejection fraction is minimal at best.

是的。謝謝卡特提出的問題。所以對於Camzyos來說，我們顯然對Camzyos的整體形象仍然非常有信心。對於患者來說，這是一種非常變革性的療法。正如您所提到的，ACC 的數據清楚地表明，在現實世界中接受治療的患者存在轉變性的結果。從安全角度來看，80% 的患者接受了 2.5 毫克和 5 毫克劑量的治療，整體結果仍然非常非常積極，而且對射血分數的影響至多也是最小的。

So certainly, it gives us an opportunity to collate that data and find the conversations continuing with the FDA at appropriate times. Remember, we've also got the nonobstructive hypertrophic cardiomyopathy study that we'll be reading out early next year. So that will provide another opportunity for us to also engage deeper into conversations for the REMS program as a whole and how we can bring this therapy to more patients as well as decrease the burden on the patients.

當然，這讓我們有機會整理這些數據，並在適當的時候與 FDA 繼續進行對話。請記住，我們還有非阻塞性肥厚型心肌病變研究，我們將於明年初宣讀。因此，這將為我們提供另一個機會，讓我們更深入參與整個 REMS 計畫的對話，以及我們如何將這種療法帶給更多患者並減輕患者的負擔。

With that, let me pass it on to Adam to comment more.

接下來，讓我將其轉告 Adam 以發表更多評論。

Yes. Thanks for the question. We're pleased with Camzyos' performance in the quarter. And we saw a nice acceleration in new patient starts. We saw about a 25% increase in patients added to commercial dispense, but that was offset as you mentioned, by approximately $25 million inventory work down from Q4 to Q1. And we saw a slight gross to net impact as well from copay restart that happened at the beginning of the year.

是的。謝謝你的提問。我們對 Camzyos 本季的表現感到滿意。我們看到新患者的開始出現了良好的加速。我們看到加入商業配藥的患者數量增加了約 25%，但這被您提到的從第四季度到第一季減少了約 2500 萬美元的庫存工作所抵消。我們也看到年初發生的共付額重新啟動對總淨額產生了輕微影響。

What we see from Camzyos is consistent positive feedback from physicians and patients. It's very positive. We're also making very good progress in the launch internationally as we work to secure reimbursement. So we're seeing good momentum for Camzyos and we feel good about the performance of this important product now until the end of the year, for sure.

我們從 Camzyos 看到的是醫生和病人一致的正面回饋。這是非常積極的。在努力確保報銷的同時，我們在國際上的推出也取得了非常好的進展。因此，我們看到 Camzyos 的良好勢頭，並且我們對這款重要產品的性能感到滿意，直到今年年底，這是肯定的。

And our next question comes from Steve Scala with TD Cowen.

我們的下一個問題來自 Steve Scala 和 TD Cowen。

This is a different version of earlier questions, but there are a number of potential obstacles in Bristol's future, Eliquis IRA price and patent expiration, Opdivo patent expiration, other patent expirations, et cetera. But based on your replies to those earlier questions, it sounds like that Bristol views the IRA price of Eliquis as the single biggest obstacle to profits in the next decade. Is that the conclusion that you'd like us to draw?

這是早期問題的不同版本，但 Bristol 的未來存在許多潛在障礙，Eliquis IRA 價格和專利到期、Opdivo 專利到期、其他專利到期等等。但根據您對先前問題的答复，布里斯托爾似乎將 Eliquis 的 IRA 價格視為未來十年利潤的最大障礙。這就是您希望我們得出的結論嗎？

And then the second question is that it was noted, Revlimid free drug was lower in Q1. Just to confirm, is that consistent with prior Revlimid guidance? And what is the reason it is lower? Was there just fewer patients requesting free drug? Or did Bristol change the terms?

第二個問題是，有人指出，來那度胺免費藥物在第一季較低。只是想確認一下，這與之前來那度胺 (Revlimid) 的指導一致嗎？而其較低的原因是什麼？是不是要求免費藥物的病人變少了？還是布里斯托改變了條款？

So Steve, I'll start, and then I'll ask the last part of your question. We've highlighted the issue around the Eliquis price and the negotiations, because that is an important consideration in the midterm as we think about this sort of transition period that we're going through that we've talked about in the middle of the decade. And so we'll have greater insight into what that impact is later this year, and we'll be able to provide more of an estimate for the impact both on top line and on EPS as we get into the back half of the decade at that time.

史蒂夫，我開始，然後我會問你問題的最後一部分。我們強調了圍繞 Eliquis 價格和談判的問題，因為這是中期的一個重要考慮因素，因為我們正在考慮我們正在經歷的這種過渡期，我們在這十年的中期討論過。因此，我們將在今年稍後更深入地了解這種影響，並且當我們進入本世紀後半段時，我們將能夠對營收和每股收益的影響提供更多估計那時。

What I would say, though, as I step back, I mean, clearly, you've articulated that -- the importance of Eliquis. And as we've discussed in the past, we have a number of LOEs that we faced during the course of the decade. But I think it's important to note as well that we've talked a lot about the importance of the growth portfolio that we had. We saw nice double-digit growth with that portfolio in the quarter.

不過，我想說的是，當我退後一步時，我的意思是，您已經清楚地闡明了 Eliquis 的重要性。正如我們過去所討論的，我們在這十年中遇到了許多 LOE。但我認為值得注意的是，我們已經談論了很多我們所擁有的成長投資組合的重要性。我們在本季看到該投資組合實現了兩位數的良好成長。

We actually are now -- about 40% of the overall business is comprised by that portfolio of products. And remember, this is a diversified portfolio of assets across each of our therapeutic areas, and we feel good about the potential of that portfolio going not only through the end of this year, but to be a catalyst for growth in the back half of the decade. And then we saw very nice progress with the pipeline over the course of the quarter.

事實上，我們現在大約 40% 的整體業務是由該產品組合組成的。請記住，這是我們每個治療領域的多元化資產組合，我們對該投資組合的潛力感到滿意，不僅會持續到今年年底，而且會成為下半年成長的催化劑。然後我們在本季度看到管道取得了非常好的進展。

So I think it's important to recognize that while IRA has an impact in the middle of the decade, we feel very good about being able to more than compensate for that with a very young and attractive growth profile coming from our growth portfolio and the pipeline. David?

因此，我認為重要的是要認識到，雖然IRA 在本世紀中期產生了影響，但我們感到非常高興能夠透過來自我們的成長投資組合和管道的非常年輕且有吸引力的成長概況來彌補這一影響。大衛？

Steve, on your question around Revlimid, just a couple of comments I'll make on that. One is what I said is that the free drug programs come down to normal levels. So no change in the program there. Just throughout last year, those levels came down in the start of this year. Remember, every calendar year, it starts again, back at traditional levels. So that was in relation to that comment.

史蒂夫，關於你關於來那度胺的問題，我只想對此發表幾點評論。一是我所說的免費藥物計劃已降至正常水平。所以那裡的程序沒有改變。就在去年全年，這些水準在今年年初有所下降。請記住，每個日曆年都會重新開始，回到傳統水平。這與該評論有關。

The other thing as it relates to Revlimid is, as we said, there's no change to our guidance this year. As previously said, it was $1.5 billion to $2 billion step down this year and the same next year. So for this year, if you remember, we exited last year at $6 billion. So we'll be in that $4 billion to $4.5 billion is our best view this year and then a further step down next year.

正如我們所說，與來那度胺相關的另一件事是，我們今年的指導沒有改變。正如之前所說，今年將減少 15 億至 20 億美元，明年也是如此。所以今年，如果你還記得的話，我們去年以 60 億美元的價格退出。因此，我們認為 40 億至 45 億美元是我們今年最好的預期，然後明年會進一步下調。

So we'll be through the LOE of Revlimid basically at the end of next year. And then as Chris talked about, we'll get insight to what's happening with Eliquis from an IRA perspective when that price becomes public here in September. And recall that the LOE for Eliquis is in 2008.

所以我們基本上會在明年年底完成 Revlimid 的 LOE。然後，正如 Chris 所說，當該價格在 9 月公開時，我們將從 IRA 的角度深入了解 Eliquis 的情況。回想一下 Eliquis 的 LOE 是在 2008 年。

And then lastly, the thing I'd say about from an LOE perspective as it relates to Opdivo, is that LOE is in December of 2028. So '29 is when that LOE would start. And then three things I'd say about that as we think about that franchise. One is we're looking forward to launching the subcutaneous formulation of that early next year. And we believe that will help that franchise continue into the next decade. I think you've heard Samit talk about Opdualag and that combination. We're really excited, number one, with its performance and standard of care in first-line melanoma, but also with the data that we're seeing in lung, we're really excited about continuing that program into Phase III and bringing that. And also, there's other tumor types that Opdualag will come in.

最後，從與 Opdivo 相關的 LOE 角度來看，我要說的是 LOE 是在 2028 年 12 月。 所以 '29 是 LOE 開始的時間。當我們考慮這個特許經營權時，我要說三件事。一是我們期待明年初推出該皮下製劑。我們相信這將有助於該系列在下一個十年繼續下去。我想您已經聽過 Samit 談論 Opdualag 和這種組合。我們真的很興奮，第一，它在一線黑色素瘤中的表現和護理標準，而且還有我們在肺部看到的數據，我們真的很高興能繼續該計畫進入第三階段並將其帶入。此外，Opdualag 也將用於治療其他腫瘤類型。

So as we think about that franchise, there's multiple avenues for that franchise to continue into the next decade.

因此，當我們考慮該特許經營權時，該特許經營權有多種途徑可以延續到下一個十年。

Just adding one thing, Steve. Around Revlimid, we had seen some volatility in generic dispensing in the quarter, including some generic supply shortages. And so Revlimid and our legacy portfolio continues to be a strong source of cash flow for the organization.

只是添加一件事，史蒂夫。在來那度胺周圍，我們看到本季仿製藥配藥出現了一些波動，包括一些仿製藥供應短缺。因此，Revlimid 和我們的傳統投資組合仍然是組織強大的現金流來源。

And our next question today comes from Trung Huynh with UBS.

今天我們的下一個問題來自瑞銀集團的 Trung Huynh。

Trung Huynh from UBS. Two from me, if that's okay. Just one on the cost saving program. How is that $1.5 billion split between this year and 2025? There's no change to your OpEx guide, but I think you noted savings were absorbed by the deals. Is 2024 the main year you'll see most of these costs realized?

瑞銀 (UBS) 的 Trung Huynh。如果可以的話，我給你兩份。只是一項關於成本節約計劃的內容。今年到 2025 年這 15 億美元如何分配？您的營運支出指南沒有變化，但我認為您注意到節省已被交易吸收。 2024 年是您將看到大部分成本實現的主要年份嗎？

And then just on Abecma, you have KarMMa-3 on the label now. You noted it's going to be important for growth. How quickly can we start to see that helping? Is it realistic to see an inflection immediately?

然後就在 Abecma 上，現在標籤上有 KarMMa-3。您指出這對成長很重要。我們多久才能開始看到這種幫助？立即看到變化是否現實？

Thanks for the question, Trung. David, then Adam.

謝謝你的提問，特朗。大衛，然後是亞當。

Yes, the vast majority of the savings comes through this year. Because if you think through the actions that we're taking, whether it's positions, the portfolio actions, we made those actions immediately and the third-party spend, we'll receive that. And then you have it annualize fully next year. So that's really the difference between '24 and '25. But it's safe to say that most of all the actions we're taking, 90% of those are being done this quarter.

是的，絕大多數節省都是今年實現的。因為如果你仔細考慮我們正在採取的行動，無論是部位、投資組合行動，我們立即採取這些行動以及第三方支出，我們都會收到這些。然後你可以在明年將其完全年度化。這就是 24 和 25 之間的差異。但可以肯定地說，我們正在採取的大部分行動，其中 90% 是在本季完成的。

Yes. Trung, as it relates to Abecma, we're certainly pleased with the regulatory approvals of KarMMa-3 in a triple class-exposed setting in the U.S., in Europe and in Japan. This will remain a very competitive space with multiple products and modalities available. Our focus is on educating physicians on the KarMMa-3 data, Abecma's differentiated and predictable safety profile as well as the manufacturing reliability that we've had with Abecma.

是的。 Trung，就 Abecma 而言，我們當然對 KarMMa-3 在美國、歐洲和日本的三重暴露環境中獲得監管批准感到高興。這仍將是一個競爭非常激烈的領域，有多種產品和模式可供選擇。我們的重點是向醫生提供有關 KarMMa-3 數據、Abecma 差異化且可預測的安全性以及 Abecma 的製造可靠性的教育。

We're also focused on expanding our site footprint in the U.S. and around the globe, making Abecma available to more patients. So we believe that there is a place for multiple assets in this market, and our objective is to return Abecma to growth over time as we move into a larger patient population.

我們也致力於擴大我們在美國和全球各地的站點覆蓋範圍，讓更多患者能夠使用 Abecma。因此，我們相信多種資產在這個市場上有一席之地，我們的目標是隨著我們進入更大的患者群體，讓 Abecma 隨著時間的推移恢復成長。

Our next question comes from Matthew Phipps with William Blair.

我們的下一個問題來自馬修·菲普斯和威廉·布萊爾。

Adam, I was wondering if you can comment on -- is there any path to grow Opdualag in melanoma outside the United States? Or will additional data be needed?

Adam，我想知道您是否可以發表評論——在美國以外的地區，是否有任何途徑可以在黑色素瘤中種植 Opdualag？或是否需要額外的數據？

And then maybe for Samit. On KRYSTAL-12, I don't suppose you can give us any tidbits on trends and overall survival at this point. I know the study is ongoing there, but maybe, if not just confidence in that data set as it stands today being able to support full approval.

然後也許是薩米特。關於 KRYSTAL-12，我認為您目前無法向我們提供任何有關趨勢和整體生存的花絮。我知道這項研究正在進行中，但也許，如果不是僅僅對目前的數據集有信心，能夠支持完全批准。

Yes. I'll start. Thanks for the question. First, I'd say we're pleased with our continued progress as Opdualag has become the standard of care in the United States in first-line metastatic melanoma. We saw over 70% growth versus prior year. And our market share now is above 25% in the U.S., and we still have further room to grow penetrating what's still around 15% monotherapy use.

是的。我開始吧。謝謝你的提問。首先，我想說，我們對我們的持續進展感到高興，因為 Opdualag 已成為美國一線轉移性黑色素瘤的護理標準。我們看到與去年相比增長了 70% 以上。目前我們在美國的市佔率已超過 25%，而且我們仍有進一步成長的空間，滲透率仍約為 15% 的單一療法使用。

It's exciting because we're also starting to launch internationally in markets like Australia, in Canada and Brazil as well as several European markets. We still have not had an opportunity to launch in Germany, but we are working on that negotiation. And we're hopeful that we have an opportunity to launch there sometime in the back end of this year and into next year.

令人興奮的是，我們也開始在澳洲、加拿大和巴西等市場以及幾個歐洲市場開展國際業務。我們還沒有機會在德國推出，但我們正在努力進行談判。我們希望有機會在今年年底和明年的某個時候在那裡推出。

Additionally, as spoken earlier, we're very pleased to have the proof-of-concept study with LAG-3 on top of PD-L1s and chemo in first-line lung cancer. And when you add that up, coupled with opportunities with lung and adjuvant melanoma, Opdualag truly has the potential to meaningfully extend our I-O franchise well into the next decade.

此外，如前所述，我們非常高興能夠在 PD-L1 和第一線肺癌化療的基礎上進行 LAG-3 的概念驗證研究。當你把這些加起來，再加上肺部和輔助黑色素瘤的機會時，Opdualag 確實有潛力將我們的 I-O 特許經營權有意義地延伸到下一個十年。

And thank you for the question. If I think about KRYSTAL-12, remember, this is a study with a primary end point in progression-free survival. And you will see the data being presented at ASCO. Overall survival data remains immature at this time, so I will not be able to comment on the specifics of that. But really excited for the confirmation of the single-arm study previously done now with the randomized study here.

謝謝你的提問。如果我想到 KRYSTAL-12，請記住，這是一項以無惡化存活期為主要終點的研究。您將看到 ASCO 上展示的數據。目前整體生存數據仍不成熟，因此我無法對其具體細節發表評論。但對於先前進行的單臂研究現在透過隨機研究得到證實感到非常興奮。

Our next question comes from Olivia Brayer with Cantor Fitzgerald.

我們的下一個問題來自奧利維亞·布雷耶和坎托·菲茨杰拉德。

What does the commercial rollout strategy look like for KarXT as we look past that September PDUFA? And any thoughts around Medicaid negotiations?

當我們回顧 9 月的 PDUFA 時，KarXT 的商業推廣策略是什麼樣的？關於醫療補助談判有什麼想法嗎？

And then when do you think we start to see some meaningful growth from that franchise, whether that's next year or more so in 2026?

那麼您認為我們什麼時候開始看到該系列產品出現一些有意義的成長，無論是明年還是 2026 年？

Adam?

亞當？

Yes. Thanks for the question. So we're very excited about the opportunity to launch KarXT later this year. This is a very important drug with significant commercial potential. As we talked about, KarXT will be the first innovative therapy in schizophrenia approved for decades. And what we've shared is KarXT offers Zyprexa-like efficacy without the significant adverse event that's plagued the D2 such as weight gain, lipidemia, EPS. And we know how compelling this is for physicians. We are rapidly preparing for the launch and the plans are going well, and we will be ready to launch by the summer, well in advance of our PDUFA date.

是的。謝謝你的提問。因此，我們對今年稍後推出 KarXT 的機會感到非常興奮。這是一種非常重要的藥物，具有巨大的商業潛力。正如我們所討論的，KarXT 將是數十年來第一個獲得批准的精神分裂症創新療法。我們分享的是 KarXT 提供了與 Zyprexa 類似的功效，並且沒有困擾 D2 的重大不良事件，例如體重增加、血脂、EPS。我們知道這對醫生來說有多引人注目。我們正在迅速為發布做準備，計劃進展順利，我們將在夏季準備好發布，比 PDUFA 日期提前很多。

We've been focused on prelaunch efforts and made very good progress preparing for the launch. So Karuna had made good progress in sourcing a very experienced commercial organization and our field medical and our access teams have already begun meaningful conversations with thought leaders and payers. Our prelaunch efforts today are focused on driving awareness of this new mechanism. We're currently building out a large neuroscience field sales organization. In fact, we've increased the investment across multiple fronts to maximize the opportunity that we have.

我們一直專注於啟動前的工作，並在啟動準備工作中取得了很好的進展。因此，卡魯納在尋找經驗豐富的商業組織方面取得了良好進展，我們的現場醫療和訪問團隊已經開始與思想領袖和付款人進行有意義的對話。我們今天的啟動前工作重點是提高人們對這個新機制的認識。我們目前正在建立一個大型的神經科學現場銷售組織。事實上，我們增加了多個方面的投資，以最大限度地利用我們所擁有的機會。

So we also need to ensure that physicians have a positive first experience. So we're focused on building our customer model to make sure that we have the optimal physician caregiver and patient support. And as you alluded to, we know that achieving rapid access is important. And so this is a largely Medicaid and Medicare opportunity, around 70%, and our access teams are ready today. We will leverage our large access organization to ensure rapid access for patients. Our teams have already been out and meeting with state Medicaid directors, and the feedback on the product profile has been very, very positive.

因此，我們也需要確保醫生有正面的初次體驗。因此，我們專注於建立我們的客戶模型，以確保我們擁有最佳的醫生護理人員和患者支援。正如您所提到的，我們知道實現快速存取非常重要。因此，這主要是醫療補助和醫療保險的機會，大約 70%，我們的訪問團隊今天已經準備好了。我們將利用我們龐大的准入組織來確保患者的快速准入。我們的團隊已經出去與州醫療補助董事會面，對產品簡介的回饋非常非常正面。

So over half of state Medicaid programs either have no step edits or a single step edit. So our goal is to improve the quality of access to only one step edit, which you know is going to take some time, but we're very confident in our ability to achieve quality access for this product. So given a September '26 PDUFA and some of the timelines to obtain broad Medicaid coverage, we effectively see this as a 2025 launch, but we're very excited about the potential of KarXT and we plan to make this a very big product for Bristol-Myers Squibb.

因此，超過一半的州醫療補助計劃要么沒有步驟編輯，要么只有一步編輯。因此，我們的目標是提高一步編輯的訪問質量，您知道這將需要一些時間，但我們對此產品實現高品質訪問的能力非常有信心。因此，考慮到26 年9 月的PDUFA 和獲得廣泛醫療補助覆蓋的一些時間表，我們實際上將其視為2025 年推出，但我們對KarXT 的潛力感到非常興奮，我們計劃將其打造成布里斯托爾的一個非常大的產品-邁爾斯施貴寶。

Thanks, Adam. We're starting to run a little short on time, maybe take 2 or 3 more. Can we go to the next one?

謝謝，亞當。我們的時間開始有點少了，可能還需要 2 到 3 個時間。我們可以去下一個嗎？

Our next question comes from James Shin with Deutsche Bank.

我們的下一個問題來自德意志銀行的 James Shin。

I had a question on Opdualag Phase II for frontline multiple cell lung. I know the full data set is for readout in the second half, but can you share if what you've seen is any different or comparable to the other LAG-3 non-small cell data sets such as [TACD]?

我對用於一線多細胞肺的 Opdualag II 期有疑問。我知道完整的數據集將在下半年讀出，但是您能否分享一下您所看到的內容是否與其他 LAG-3 非小蜂窩數據集（例如 [TACD]）有任何不同或可比較？

Certainly, I can take that question. Look, obviously, I can't comment on what others have seen. All we know is they've seen six patients worth of data. Hard to compare six patients worth of data with more than 200 patients treated with Opdualag plus chemotherapy in the first-line setting.

當然，我可以回答這個問題。顯然，我無法評論其他人所看到的。我們所知道的是他們已經看過六名患者的數據。很難將 6 名患者的數據與 200 多名在第一線接受 Opdualag 聯合化療的患者進行比較。

What we have seen is overall review of our own data set, looking at the various endpoints that we looked at as well as the biomarkers we looked at in our [profile] and we remain confident in the profile of the drug to take it forward into the Phase III.

我們所看到的是對我們自己的數據集的總體審查，查看我們研究的各種終點以及我們在[簡介]中查看的生物標誌物，我們對藥物的概況充滿信心，並將其推進到第三階段。

Our next question comes from Kripa Devarakonda with Truist Securities.

我們的下一個問題來自 Truist Securities 的 Kripa Devarakonda。

I had a question about your acquisition of RayzeBio and now that you've got enablement and we're seeing -- it's getting to be very competitive. Just wanted to see what the urgency and what this strategy is to build out the radiopharma pipeline. And also, when can we see more details on what the priorities are and also regarding actinium production going live?

我對你們收購 RayzeBio 有一個疑問，現在你們已經獲得了支持，我們看到——它變得非常有競爭力。只是想看看建立放射性藥物管道的緊迫性和策略是什麼。此外，我們什麼時候可以看到有關優先事項以及錒生產上線的更多詳細資訊？

Well, let me start and then I'll ask Samit and Adam to speak. Let me just at a high level, though, say, that we continue to be incredibly excited about radiopharmaceuticals as a platform. It's one of the fastest-growing platform in solid tumor oncology. We believe we have a best-in-class asset that we've acquired with Rayze.

好吧，讓我開始，然後我會請薩米特和亞當發言。不過，讓我從高層次來說，我們仍然對放射性藥物作為一個平台感到非常興奮。它是實體瘤腫瘤學領域成長最快的平台之一。我們相信我們擁有透過 Rayze 收購的一流資產。

The integration of that team has gone very well. We continue to be very excited and happy with the bringing online of the facility in Indianapolis. So in terms of us getting that asset, incredible enthusiasm and the integration has gone well. But Samit, maybe you and Adam can speak to details.

該團隊的整合進展順利。我們對印第安納波利斯工廠的上線仍然感到非常興奮和高興。因此，就我們獲得該資產而言，令人難以置信的熱情和整合進展順利。但是薩米特，也許你和亞當可以談談細節。

Yes. Thank you for the question. For Rayze, as Chris just mentioned, the platform is absolutely exciting and very encouraging data that we have seen emerging from the first program that is already in Phase III for the SSTR directed radioligand therapy. And that Phase III program is right now enrolling in the GEP-NET indication as well as the small cell lung cancer Phase I studies ongoing, and we are looking to see a couple of other indications added over there, and we're designing those trials as we speak and conduct those. So it holds a huge amount of promise because of the specificity of the directed radiation to the tumor itself.

是的。感謝你的提問。對於Rayze 來說，正如Chris 剛才提到的，該平台絕對是令人興奮和非常令人鼓舞的數據，我們已經從第一個項目中看到了這些數據，該項目已經處於SSTR 定向放射配體治療的III 期。這個 III 期計畫目前正在註冊 GEP-NET 適應症以及正在進行的小細胞肺癌 I 期研究，我們希望看到其他幾個適應症的添加，我們正在設計這些試驗當我們說話和進行這些活動時。因此，由於定向輻射對腫瘤本身的特異性，它具有巨大的前景。

Thereafter, we're looking forward to additional IND filing later this year, and that might then be able to start our actually very specific tumor-directed indication within HCC at the back half of this year. And then thereafter, we are looking to see an IND generation coming from this platform as we go forward.

此後，我們期待在今年稍後提交更多 IND 申請，然後可能能夠在今年下半年開始我們在 HCC 領域實際上非常具體的腫瘤導向適應症。此後，隨著我們的前進，我們期待看到來自該平台的 IND 世代。

With the Indianapolis manufacturing facility now up and running, we're looking forward to supplying the actinium part of it as well as the drug product towards the back half -- or back end to early part of next year, and that will certainly help in terms of continuing to supply and taking it forward. We are learning lessons from the front runners and those lessons will be very helpful as we go into the commercial stages in a couple of years.

隨著印第安納波利斯製造工廠現已建成並投入運行，我們期待在下半年（或明年初下半年）供應錒部分以及藥品，這肯定會有助於繼續供應並推進的條款。我們正在從領導者身上吸取經驗教訓，當我們在幾年後進入商業階段時，這些經驗將非常有幫助。

Adam, anything to add?

亞當，有什麼要補充的嗎？

Yes, I'll just add just a few things. RayzeBio was an important strategic acquisition that we believe continues to diversify our oncology portfolio. It's -- as Chris mentioned, we see this as a modality that's going to continue to grow over time. It will be a competitive space.

是的，我只會添加一些內容。 RayzeBio 是一項重要的策略性收購，我們相信它將繼續使我們的腫瘤學產品組合多樣化。正如克里斯所提到的，我們認為這是一種隨著時間的推移而繼續發展的模式。這將是一個競爭空間。

But what we liked about RayzeBio, this is going to be an IND engine. And the lead program RYZ101 is already in Phase III development, as you heard earlier, for GEP-NET. But we have opportunities in small cell lung cancer, in breast cancer and potentially many other tumor types. So this is tremendously complementary to our existing portfolio.

但我們喜歡 RayzeBio 的一點是，這將是一個 IND 引擎。正如您之前所聽到的，主導專案 RYZ101 已經處於 GEP-NET 的第三階段開發中。但我們在小細胞肺癌、乳癌和許多其他腫瘤類型方面有機會。因此，這對我們現有的產品組合是極大的補充。

And maybe we could go to our last question, if you don't mind, Rocco?

如果你不介意的話，也許我們可以討論最後一個問題，羅科？

Our final question comes from Akash Tewari with Jefferies.

我們的最後一個問題來自傑弗里斯的阿卡什·特瓦里 (Akash Tewari)。

This is Ivy on for Akash. We just have two quick questions. The first one is a follow-up for KarXT. So do you think patients on the drug will develop tardive dyskinesia? If not, how will that help position KarXT in the schizophrenia market?

這是阿卡什的常春藤。我們只有兩個簡單的問題。第一個是 KarXT 的後續版本。那麼您認為服用該藥的患者會出現遲發性運動障礙嗎？如果不是，這將如何幫助 KarXT 在精神分裂症市場中定位？

And then our second question is for CAR-T. So why do you think CAR-T for autoimmune is more attractive than CD19 bispecifics? And also, would you consider approaches that don't require lymphodepletion?

我們的第二個問題是關於 CAR-T 的。那麼，為什麼您認為用於自體免疫的 CAR-T 比 CD19 雙特異性抗體更具吸引力呢？另外，您會考慮不需要淋巴清除的方法嗎？

Samit?

薩米特？

Sure. Thank you. First of all, great profile for KarXT that I think Adam has spoken about earlier from a safety profile perspective and the data has recently been presented also at the SIRS conference where we do not see the same toxicities that are seen with the atypical such as the tardive dyskinesia, the movement disorders as well as many of the other elements that have been spoken about, so I won't repeat. So that's why we are very confident on the profile and looking forward to bring it to the patients with schizophrenia. And then as David said earlier, with other indications as well for AD psychosis, agitation, bipolar disorders and others that we are exploring.

當然。謝謝。首先，我認為 Adam 之前已經從安全概況的角度談到了 KarXT 的出色概況，並且最近也在 SIRS 會議上介紹了這些數據，在會上我們沒有看到與非典型藥物（例如遲發性運動障礙、運動障礙以及許多其他因素已經談過，所以我不再重複。這就是為什麼我們對這個概況非常有信心，並期待將其帶給精神分裂症患者。正如 David 之前所說，還有 AD 精神病、躁動、躁鬱症和我們正在探索的其他適應症。

On the CAR-T side, certainly an advantage for a single infusion leading to good outcomes for patients, especially starting with SLE in the refractory setting, where patients have had multiple other treatments ongoing and organ dysfunction factors in these patients. That is the advantage, a single infusion, if that can cause tremendous transformational outcomes for these patients.

在CAR-T 方面，單次輸注無疑有一個優勢，可以為患者帶來良好的結果，特別是在難治性系統性紅斑狼瘡開始時，患者已經接受了多種其他治療，並且這些患者存在器官功能障礙因素。如果單次輸注能為這些患者帶來巨大的轉變結果，這就是優勢。

As you know, our program is quite large. So we are also looking at multiple sclerosis as well as systemic sclerosis as well as idiopathic myositis. So those programs as they enroll patients will generate the data, and we're hoping to be able to present some data from SLE this year and certainly, future approaches might include non-lymphodepletion therapies, but we're not ready for that right now.

如您所知，我們的計劃非常龐大。因此，我們也關注多發性硬化症、系統性硬化症以及特發性肌炎。因此，這些計畫在招募患者時將產生數據，我們希望能夠提供今年 SLE 的一些數據，當然，未來的方法可能包括非淋巴細胞清除療法，但我們現在還沒有準備好。

Thanks, Samit. And maybe I'll just close by saying, first, thank you all for joining the call today. I know it is a very busy day for all of you. So maybe I'll just leave you with a few things. First, we're off to a very good start in 2024. Our performance this quarter reflects execution and actions that we've taken to strengthen the company's long-term growth profile. Our business out remains unchanged from the beginning of the year. And of course, we look forward to sharing our continued progress on future calls.

謝謝，薩米特。最後，也許我會說，首先，感謝大家參加今天的電話會議。我知道這對你們所有人來說都是非常忙碌的一天。所以也許我會留給你一些東西。首先，我們在 2024 年有了一個良好的開端。我們的業務與年初相比沒有變化。當然，我們期待在未來的電話會議上分享我們的持續進展。

And with that, we'll close the call. And as always, the team is available to answer any questions you have following today's discussion, and I hope all of you have a very good day.

至此，我們就結束通話了。像往常一樣，該團隊可以回答您在今天的討論後提出的任何問題，我希望大家度過愉快的一天。

Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.

謝謝。今天的電話會議到此結束。我們感謝大家參加今天的演講。您現在可以斷開線路，度過美好的一天。