施貴寶 (BMY) 2023 Q4 法說會逐字稿

Welcome to the Bristol-Myers Squibb Fourth Quarter 2023 Earnings Conference Call. (Operator Instructions) Please note, this event is being recorded. I would now like to turn the conference over to Tim Power, Vice President and Head of Investor Relations. Please go ahead.

歡迎參加百時美施貴寶 2023 年第四季財報電話會議。 （操作員指示）請注意，此事件正在記錄中。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 fourth quarter 2023 earnings call. Joining me this morning with prepared remarks are Chris Boerner, our 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，早安。感謝您今天上午參加我們的 2023 年第四季財報電話會議。今天早上與我一起發表準備好的發言的有我們的執行長 Chris Boerner；以及我們的財務長David Elkins。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。正如您所注意到的，我們已將幻燈片發佈到 bms.com，您可以使用它來關注 Chris 和 David 的演講。

Before we get started, I'll read our forward-looking statements. 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. 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.

在我們開始之前，我將宣讀我們的前瞻性聲明。在本次電話會議中，我們將對公司的未來計畫和前景做出前瞻性的陳述。由於各種重要因素（包括公司向美國證券交易委員會提交的文件中討論的因素），實際結果可能與這些前瞻性陳述所示的結果有重大差異。這些前瞻性陳述代表我們截至今天的估計，不應被視為代表我們對任何未來日期的估計。我們明確表示不承擔更新前瞻性聲明的任何義務，即使我們的估計發生變化。

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

我們還將重點關注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的 GAAP 指標的對帳表可在 bms.com 上查閱。

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

說完這些，我就把麥克風交給克里斯。

Thanks, Tim, and good morning to all of you. I'm very pleased to be speaking to you on our earnings call for the first time as CEO, and I'm excited about the opportunity for our company to continue to deliver transformational medicines for patients. Please turn to Slide 4.

謝謝，提姆，大家早安。我很高興作為執行長第一次在我們的財報電話會議上與大家交談，我很高興我們公司有機會繼續為患者提供變革性藥物。請翻到幻燈片 4。

Q4 2023 was a good quarter, including strong sales momentum in our in-line and new product portfolio with 9% growth and nearly $10 billion in revenue with growth across multiple key brands, including Eliquis, Opdivo, Reblozyl, Opdualag, Breyanzi, Camzyos and Sotyktu. We also continued to generate significant cash flows from operations of $4.3 billion in the quarter. And as you'll hear from David in a few minutes, we expect to grow our business this year.

2023 年第四季表現良好，我們的線上和新產品組合銷售勢頭強勁，成長 9%，營收接近 100 億美元，多個主要品牌均實現成長，包括 Eliquis、Opdivo、Reblozyl、Opdualag、Breyanzi、Camzyos 和 Sotyktu。本季我們也持續從經營活動產生大量現金流，達到 43 億美元。幾分鐘後您將從戴維那裡聽到，我們預計今年的業務將會成長。

During the fourth quarter, we also achieved important pipeline milestones in several key business development transactions to strengthen our growth profile. This is an important time for BMS. I know that many of you are focused on our strategy to navigate the decade and on the importance of disciplined execution at the company. We are writing the next chapter for BMS and with that, comes an opportunity for change. So let me take a few minutes to tell you about our strategy to navigate our LOEs and be very clear about my focus on execution.

第四季度，我們還在幾項關鍵業務發展交易中取得了重要的里程碑，從而增強了我們的成長勢頭。對BMS來說，這是一個重要的時刻。我知道你們中的許多人都關注著我們未來十年的策略，以及公司嚴格執行的重要性。我們正在為 BMS 書寫新的篇章，這也帶來了改變的機會。因此，請容許我花幾分鐘向您介紹我們駕馭 LOE 的策略，並明確說明我對執行的重點。

Let's go to Slide 5 and how we see the company today. When we look at our business, it's comprised of 2 portfolios. First, we see a legacy portfolio of well-established products facing headwinds such as IRA. Though this portfolio is declining, it is expected to continue to generate strong cash flows to enable investment in our future growth drivers.

讓我們來看第 5 張投影片，看看目前對公司的看法。當我們審視我們的業務時，它由兩個投資組合組成。首先，我們看到一批成熟的傳統產品正面臨 IRA 等阻力。儘管該投資組合正在下降，但預計它將繼續產生強勁的現金流，以支持我們未來成長動力的投資。

Second, we see an expanding portfolio of growth products, many of which are relatively newer to the market and have significant expansion potential. When you look at these portfolios, combined with our exciting pipeline, you can see how it all comes together as depicted on Slide 6. As we think about this decade, we see 3 distinct periods: a near-term growth period, a transition period and potential for sustainable top-tier growth, which we plan to drive in the back end of the decade.

其次，我們看到成長產品組合不斷擴大，其中許多產品相對較新，具有巨大的擴張潛力。當您查看這些投資組合，結合我們令人興奮的產品線時，您可以看到它們是如何組合在一起的，如幻燈片 6 所示。

Between now and the middle of the decade, our focus will be on maximizing the opportunity we have with our growth portfolio. This, along with pipeline execution, can best position the company into the transition period. Then starting around 2026, our exposure is most acute, and our focus will be on shortening the transition period as much as possible by accelerating our R&D programs, executing on product approvals and launches while maintaining P&L discipline.

從現在到2025年，我們的重點將是最大限度地利用我們的成長投資組合所帶來的機會。這與管道執行一起，可以使公司最好地進入過渡期。從 2026 年左右開始，我們的風險敞口將最為顯著，我們的重點將是盡可能縮短過渡期，加快我們的研發計劃，執行產品審批和發布，同時保持損益紀律。

Finally, in the latter part of the decade, around 2028 and beyond, we plan to deliver sustainable top-tier growth, and we have the portfolio, pipeline and financial flexibility to support this opportunity. Many of you recognize the first 2 periods. However, the late decade return to growth phase is less appreciated externally, including a number of important products that are not fully appreciated in consensus models today. What supports our confidence is our expanding pipeline, recent deals and newly launched products. Our strategy is to minimize the transition period coming in a few years while maximizing our growth in the back part of the decade.

最後，在本世紀後期，大約在 2028 年及以後，我們計劃實現可持續的頂級成長，並且我們擁有投資組合、通路和財務靈活性來支持這一機會。你們中的許多人都認識前兩個時期。然而，近十年來重返成長階段並未受到外界充分重視，其中包括許多在當今共識模型中尚未得到充分重視的重要產品。支持我們信心的是我們不斷擴大的產品線、近期達成的交易以及新推出的產品。我們的策略是盡量縮短未來幾年的過渡期，同時最大限度地實現未來十年的成長。

Turning to Slide 7. My confidence in our strategy is supported by the fact that compared with other companies that successfully navigated similar periods, we have some clear strengths, an expanding growth portfolio across multiple therapeutic areas, an exciting pipeline, differentiated platforms and continued financial strength to further invest for growth with business development.

轉到投影片 7。

And the momentum from our most recent quarter to capitalize on these strengths is clear from Slide 8. In October, we told you we would strengthen commercial performance. And during Q4, we've been making progress. We have increased investment behind key growth brands such as Camzyos and Sotyktu. We are reaccelerating growth for Reblozyl by capitalizing on the launch of the COMMANDS indication in first-line MDS. Our efforts to further establish Opdualag as the standard of care in first-line melanoma are driving further growth.

從第 8 頁幻燈片中可以清楚地看到，我們最近一個季度利用這些優勢的勢頭。在第四季度，我們取得了進展。我們增加了對 Camzyos 和 Sotyktu 等主要成長品牌的投資。我們正在利用 COMMANDS 在 MDS 一線治療中的適應症推出的機會，重新加速 Reblozyl 的成長。我們致力於進一步確立 Opdualag 作為黑色素瘤一線治療的標準，從而推動進一步的成長。

And we have made progress expanding capacity for cell therapies, particularly setting up Breyanzi for significant expansion this year. In R&D, we delivered important milestones, including recharging our early-stage pipeline with 10 INDs as we told you we would do at our R&D Day, delivering the approval of Augtyro in first-line ROS-positive lung cancer, and advancing our key platforms, including initiating our CD19 NEX-T study in multiple sclerosis for our cell therapy program, and showing early but important Phase I data for the AR-LDD prostate asset from our targeted protein degradation platform.

我們在擴大細胞治療能力方面取得了進展，特別是為今年 Breyanzi 的大規模擴張做好了準備。在研發方面，我們實現了重要的里程碑，包括用 10 個 IND 補充我們早期的產品線，正如我們在研發日所說的那樣，獲得 Augtyro 在治療一線 ROS 陽性肺癌方面的批准，並推進我們的關鍵平台，包括啟動我們細胞治療項目在多發性硬化症中的 CD19 NEX-T 研究，並展示來自我們的前列腺數據的早期目標 ILD 期患者的數據降解。

Importantly, we've been active in business development. Specifically, we further diversified our oncology portfolio with targeted oncology assets such as Krazati and PRMT5 from the recently completed Mirati acquisition, the planned addition of a differentiated bispecific ADC from SystImmune with exciting Phase I data across tumors, including lung and breast cancers, and the planned acquisition of RayzeBio bringing important radiopharmaceutical assets, pipeline and manufacturing capabilities.

重要的是，我們一直積極開展業務發展。具體而言，我們進一步豐富了我們的腫瘤學產品組合，包括最近完成的 Mirati 收購中的 Krazati 和 PRMT5 等靶向腫瘤學資產、計劃增加的 SystImmune 差異化雙特異性 ADC（該 ADC 擁有針對肺癌和乳腺癌等腫瘤的令人興奮的 I 期數據），以及計劃收購的 RayzeBio，從而帶來重要的放射性藥物、管道和製造能力。

And we announced the planned acquisition of Karuna Therapeutics, bringing KarXT, which we believe will be a transformational medicine for patients with schizophrenia, Alzheimer's psychosis and potentially other indications with multibillion-dollar sales potential. We are looking forward to launching this medicine after closing the transaction later this year. These deals add important growth substrate to our company and diversify our portfolio for the long term.

我們還宣布了收購 Karuna Therapeutics 的計劃，帶來 KarXT，我們相信它將成為治療精神分裂症、阿茲海默症及其他潛在疾病的變革性藥物，具有數十億美元的銷售潛力。我們期待在今年稍後完成交易後推出這款藥物。這些交易為我們公司增加了重要的成長基礎，並使我們的投資組合長期多樣化。

Let's turn to Slide 9. Execution for me is a top priority. Starting with commercial. The focus is on continuing to accelerate performance for key growth drivers. This means ensuring the right resourcing and investment levels across our most important brands, and it means having the best people and driving accountability for delivering results.

讓我們翻到投影片 9。從商業開始。重點是持續加快關鍵成長動力的績效。這意味著確保我們最重要的品牌擁有適當的資源和投資水平，這意味著擁有最優秀的人才並推動對實現成果的責任感。

In R&D, building on the momentum, I described coming out of last quarter. As we highlighted at our R&D Day, we have a strong pipeline with the potential to deliver over 16 NMEs through the late 2020s. And here, we need to accelerate and deliver top-tier productivity. We are also taking a hard look at our pipeline to prioritize investments for projects with higher return opportunities and discontinuing lower priority programs.

在研發方面，我利用這股動能描述了上個季度的情況。正如我們在研發日上所強調的那樣，我們擁有強大的產品線，有潛力在 2020 年代末交付超過 16 種 NME。在這裡，我們需要加速並提供一流的生產力。我們也正在認真審視我們的投資管道，優先投資具有更高回報機會的項目，並停止優先順序較低的項目。

And to our OpEx base. As we told you, we are going to absorb the OpEx from Karuna. This means we need to make room for these assets by focusing our OpEx base to increase efficiency and productivity. We have begun executing across all 3 fronts, and look forward to updating you on our progress in future quarters. We plan to grow our business this year as shown on Slide 10. David will provide much more detail on our guidance in a few minutes.

以及我們的 OpEx 基地。正如我們告訴您的那樣，我們將吸收來自卡魯納的營運支出。這意味著我們需要透過集中我們的營運支出基礎來提高效率和生產力，為這些資產騰出空間。我們已開始在所有三個方面執行任務，並期待在未來幾季向您通報我們的進展。如幻燈片 10 所示，我們計劃今年擴大業務。

But what's important from my perspective is that getting our long-term plan to work requires us to deliver well in the short term. A few weeks ago, I reaffirmed our long-term targets as of that date. At that time, I also said we were going back to our historical practice of providing mainly annual guidance with total company rather than product-level revenue targets. Therefore, we will not be updating those long-term targets moving forward. With that in mind, you can see that our growth portfolio is strengthening and our guidance reflects expected top line growth this year.

但從我的角度來看，重要的是，要讓我們的長期計畫發揮作用，我們就必須在短期內取得良好的成果。幾週前，我重申了我們截至該日期的長期目標。當時我還說過，我們將恢復歷史做法，主要提供整個公司的年度指導，而不是產品級的收入目標。因此，我們不會更新這些長期目標。考慮到這一點，您可以看到我們的成長組合正在加強，我們的指引反映了今年預期的營收成長。

Before I hand the call over to David, I would like to thank my BMS colleagues for their efforts at serving patients during 2023 and for their enthusiasm for embarking on our next chapter as a company. David?

在我將電話交給 David 之前，我想感謝 BMS 的同事們在 2023 年為病患服務所做的努力，以及他們對開啟公司新篇章的熱情。戴維？

Thank you, Chris, and thank you all again for joining our call today. As Chris mentioned, this is an important time for BMS as we embark on our next chapter, transforming our portfolio. Our performance in 2023 reflect the continued strong growth of our in-line and new product portfolio, and the ongoing erosion of Revlimid.

謝謝你，克里斯，再次感謝大家今天參加我們的電話會議。正如克里斯所說，對於 BMS 來說，這是一個重要的時刻，因為我們將開啟新的篇章，轉變我們的產品組合。我們 2023 年的業績反映了我們線上和新產品組合的持續強勁成長，以及 Revlimid 的持續侵蝕。

Let's get started with our top line performance on Slide 12. Unless otherwise stated, all comparisons are made versus the same period in 2022, and sales performance growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. We delivered sales of approximately $45 billion in 2023, which reflected 8% growth from our in-line and new product portfolio, offset by unfavorable impact of generic entries.

讓我們從投影片 12 的營收表現開始。 2023 年，我們的銷售額約為 450 億美元，反映了我們在產品線和新產品組合方面的 8% 成長，但抵消了仿製藥帶來的不利影響。

During the year, we saw continued strong demand for our key in-line products such as Eliquis and Opdivo, while new products gained traction in their respective markets. If you turn to Slide 13, you see our 2023 sales split between legacy and growth portfolio that Chris spoke about earlier. This is how we will report our business as we move forward. What I can tell you is the transition of the business is already well underway from our legacy to our growth portfolio.

這一年，我們看到我們的主要線上產品（例如 Eliquis 和 Opdivo）的需求持續強勁，同時新產品在各自的市場中也獲得了關注。如果您翻到第 13 張投影片，您會看到 Chris 之前提到的 2023 年傳統產品組合和成長產品組合之間的銷售分配。這就是我們今後報告業務的方式。我可以告訴你們的是，我們的業務從傳統組合轉變為成長組合的轉變已經順利進行了。

For 2023, our growth portfolio delivered approximately 15% growth. This supports our strategy that Chris discussed earlier. We see our legacy portfolio providing a solid foundation for cash flow generation in the near term, while the products within our growth portfolio grow in significance. Let me dive deeper into our fourth quarter and full year sales performance starting with our oncology portfolio on Slide 14.

預計到 2023 年，我們的成長投資組合將實現約 15% 的成長。這支持了克里斯之前討論的我們的策略。我們認為，我們的傳統產品組合為短期現金流創造提供了堅實的基礎，而我們成長產品組合中的產品的重要性日益增強。讓我從投影片 14 上的腫瘤學產品組合開始，更深入地介紹我們第四季和全年的銷售表現。

We are pleased with the robust demand for Opdivo, which achieved strong global sales growth for the year. In the fourth quarter, U.S. sales grew 12%, primarily driven by increased volume in core indications, including first-line lung, upper GI and adjuvant bladder cancer, partially offset by optimized growth in first-line melanoma.

我們對 Opdivo 的強勁需求感到高興，該產品今年實現了強勁的全球銷售成長。第四季度，美國銷售額成長了 12%，主要得益於核心適應症（包括第一線肺癌、上消化道癌和輔助性膀胱癌）的銷售成長，但一線黑色素瘤的優化成長部分抵消了這一增長。

During the quarter, U.S. and international markets each benefited from approximately $50 million of favorable stocking. Internationally, sales grew 4%, led by increased demand for lung and gastric cancer indications and from expanded reimbursement.

本季度，美國和國際市場分別受惠於約 5,000 萬美元的優惠庫存。在國際上，銷售額增加了 4%，主要是由於肺癌和胃癌治療需求增加以及報銷範圍擴大。

Turning to Opdualag, which more than doubled its full year sales in 2023 and it's now a standard of care treatment in first-line melanoma. In the fourth quarter, U.S. sales grew 80% versus the prior year and 15% sequentially, benefiting from its strong market share position. With respect to sales of Augtyro in the fourth quarter, we launched in late November and upon U.S. approval and Q4 sales reflecting initial wholesaler stocking. During 2024, we look forward to bringing this important medicine to more patients.

談到 Opdualag，其 2023 年全年銷售額增長了一倍以上，目前已成為一線黑色素瘤的標準治療方法。第四季度，得益於強大的市場份額，美國銷售額較上年同期成長 80%，較上一季成長 15%。關於第四季度 Augtyro 的銷售，我們於 11 月下旬推出，並獲得美國批准，第四季度的銷售反映了初始批發商的庫存。 2024年，我們期待將這項重要藥物帶給更多患者。

Let's turn to our cardiovascular on Slide 15. Eliquis generated over $12 billion in sales in 2023 and continues to be the #1 oral anticoagulant globally. In fourth quarter, sales grew, primarily driven by demand in the U.S. as we continue to gain market share from competitors. Internationally, sales in Q4 were broadly flat, driven by generic entry in several European markets.

讓我們轉到幻燈片 15 上的心血管領域。第四季度，銷售額實現成長，主要受美國需求的推動，因為我們繼續從競爭對手手中奪取市場份額。從國際上看，第四季的銷售額基本上持平，原因是仿製藥進入幾個歐洲市場。

Sales of Camzyos in the fourth quarter and full year were strong, including $88 million in Q4. As of December 31, we had roughly 4,500 patients on commercial drug. And on average, we have been adding roughly 1,000 patients to commercial drug per quarter. The momentum in the U.S. for Camzyos is expected to continue in 2024. And internationally, we expect modest near-term sales contribution based on timing of reimbursement in newly launched markets.

Camzyos 第四季和全年銷售強勁，其中第四季銷售收入達 8,800 萬美元。截至 12 月 31 日，我們約有 4,500 名患者使用商業藥物。平均而言，每季我們都會為商業藥品增加約 1,000 名患者。 Camzyos 在美國的勢頭預計將持續到 2024 年。

Turning to our hematology portfolio performance on Slide 16, starting with Revlimid. Global sales for the full year were approximately $6 billion. Looking forward, we anticipate continued variability in Revlimid sales quarter-to-quarter based upon historic patterns in specialty pharmacy dispensing. We anticipate an additional volume of U.S. generics to enter the market in March. We continue to forecast a step-down in Revlimid revenues in the range of $1.5 billion to $2 billion this year.

談談幻燈片 16 上的血液學產品組合表現，首先是 Revlimid。全年全球銷售額約 60 億美元。展望未來，根據專科藥局配藥的歷史模式，我們預計 Revlimid 的銷售額將逐季持續波動。我們預計三月將有更多的美國仿製藥進入市場。我們繼續預測今年 Revlimid 的營收將下降 15 億美元至 20 億美元。

Now moving to Reblozyl. Global sales grew 40% in 2023, surpassing $1 billion on an annualized basis for the first time. For the quarter, Reblozyl generated 60% sales growth driven by strong demand and supported by a broad U.S. first-line label. Sales grew 75% in the U.S. in Q4. Internationally, Reblozyl continues to be launched in different markets across the globe, including recently in Japan.

現在轉向 Reblozyl。 2023年全球銷售額將成長40%，年化銷售額首次超過10億美元。本季度，在強勁需求的推動下以及美國一線品牌的廣泛支持下，Reblozyl 的銷售額成長了 60%。第四季美國銷售額成長了 75%。在國際上，Reblozyl 繼續在全球不同市場推出，包括最近在日本。

Turning to our cell therapy portfolio, starting with sales of Abecma in the U.S., we continue to experience competitive impacts. While ex-U.S., demand remained strong in the quarter. We remain focused on demonstrating the benefits of the product profile to our customers' anticipation of expanded use in the U.S. upon the potential approval of KarMMA-3 data in third line plus setting. Abecma was recently approved in Japan in the third-line setting based on KarMMA-3 data. And last week, we received positive CHMP opinion.

談到我們的細胞療法產品組合，從在美國銷售 Abecma 開始，我們繼續受到競爭的影響。儘管美國以外地區的需求在本季依然強勁。我們仍將專注於向客戶展示該產品的優勢，以滿足其在美國擴大使用預期，因為 KarMMA-3 數據有可能在第三線加設定中獲得批准。根據 KarMMA-3 數據，Abecma 最近在日本獲得批准用於三線治療。上週，我們收到了 CHMP 的正面評價。

Moving to Breyanzi. Global sales doubled year-over-year, reflecting the strength of its clinical profile and an improved manufacturing capacity. We are pleased to have received FDA priority review for all 3 of our expanded indications for Breyanzi and look forward to the PDUFA date in March for chronic lymphocytic leukemia and additional PDUFA dates in May for follicular and mantle cell lymphoma indications. Looking to this year, we expect to see strong sales growth starting in the second quarter, driven by improved supply capacity and the potential for these new additional indications.

搬到布雷揚齊。全球銷售額年增一倍，反映出其臨床表現的強勁和製造能力的提高。我們很高興 Breyanzi 的所有 3 個擴大適應症均獲得了 FDA 優先審查，並期待 3 月份慢性淋巴細胞白血病的 PDUFA 日期和 5 月份濾泡性和套細胞淋巴瘤適應症的額外 PDUFA 日期。展望今年，我們預計從第二季開始銷售將出現強勁成長，這得益於供應能力的提高和這些新附加適應症的潛力。

Moving to immunology on Slide 17. Global sales of Zeposia in 2023 grew 72% to $434 million, driven by increased demand in multiple sclerosis and ulcerative colitis. We remain focused on driving growth across both indications. For 2024, keep in mind the typical impact of U.S. Zeposia sales in the first quarter due to copay assistance for commercially insured patients who benefits reset.

轉到幻燈片 17 上的免疫學。我們將繼續專注於推動兩項指標的成長。對於 2024 年，請記住美國 Zeposia 銷售在第一季的典型影響，這是由於福利重置的商業保險患者的共付額援助。

With Sotyktu, our goal continues to be driving demand and broadening access. We made good progress on both fronts in the fourth quarter. Fourth quarter sales in the U.S. also benefited from a clinical supply purchase of $17 million. When you strip out the onetime purchases in Q4 and Q3, we showed strong underlying sequential sales growth of approximately 40%, reflecting good pull-through from CVS and increased demand. Going forward, the way to look at our progress in the U.S. is through commercially paid prescriptions.

透過 Sotyktu，我們的目標仍然是推動需求和擴大使用範圍。我們在第四季度在兩個方面都取得了良好進展。美國第四季的銷售也受惠於 1700 萬美元的臨床供應採購。如果剔除第四季和第三季的一次性購買量，我們可以看到潛在的連續銷售成長強勁，約為 40%，這反映了 CVS 的良好拉動和需求的增加。展望未來，觀察我們在美國取得的進步的方式是透過商業支付處方。

As we build volume and improve access, we will be subject to higher rebates, which is something to keep in mind as you model Sotyktu for 2024. Of course, Adam can talk more about this in the Q&A portion of our call today. Internationally, we expect Sotyktu to gain additional country regulatory and reimbursement approvals over time.

隨著我們擴大產量並改善訪問管道，我們將獲得更高的回扣，這是在為 2024 年的 Sotyktu 建模時需要牢記的一點。在國際上，我們預計 Sotyktu 將隨著時間的推移獲得更多國家的監管和報銷批准。

Switching gears to our fourth quarter P&L on Slide 18. Having just covered sales performance, let me walk through a few non-GAAP key line items. Gross margin as a percentage of sales decreased approximately 150 basis points to 76.4% compared to prior year due to product mix and lower hedge settlement gains. Excluding acquired in-process R&D, fourth quarter and full year operating expenses decreased primarily due to timing of expenses in 2022.

現在轉到投影片 18 上的第四季損益表。由於產品組合和對沖結算收益減少，毛利率佔銷售額的百分比與前一年相比下降了約 150 個基點，至 76.4%。不包括收購的在研研發，第四季和全年營運費用下降主要是由於 2022 年費用的時間表。

The fourth quarter decline was partially offset by increased investments in Camzyos, Sotyktu and the timing of pipeline investments. Acquired in-process R&D in the quarter was $600 million, which was partially offset by licensing income, resulting in an unfavorable net impact of $0.20 of EPS. The fourth quarter effective tax rate was approximately 14.9%, driven primarily by earnings mix. Overall, earnings per share was $1.70 in the quarter and $7.51 for the full year.

第四季的下滑部分被對 Camzyos、Sotyktu 的投資增加和管道投資時機的調整所抵消。本季收購的在研研發費用為 6 億美元，部分被授權收入所抵消，導致每股淨收益影響為 0.20 美元。第四季有效稅率約為 14.9%，主要受獲利組合影響。總體而言，本季每股收益為 1.70 美元，全年每股收益為 7.51 美元。

Now moving to the balance sheet and capital allocation on Slide 19. Our financial position remains strong. With approximately $12.6 billion in cash and marketable securities on hand as of December 31, as we generate cash flow from operations of $4.3 billion in the fourth quarter. Through our strong financial discipline, we have been able to invest in our business and further expand our portfolio, maintain strong operating margins, pay down debt and return significant cash to shareholders through share repurchases and dividends.

現在轉到投影片 19 上的資產負債表和資本配置。截至 12 月 31 日，我們持有約 126 億美元現金和有價證券，第四季我們的營運活動現金流為 43 億美元。透過嚴格的財務紀律，我們能夠投資於我們的業務並進一步擴大我們的投資組合，保持強勁的營業利潤率，償還債務並透過股票回購和股息向股東返還大量現金。

Over the past 3 years, we've returned over $30 billion in shareholder distributions, including the dividend, which we've increased annually for 15 years in a row. As you know, we're going to be taking on additional debt this year to finance our planned acquisitions of Karuna and RayzeBio. However, with our strong financial position, we plan to utilize our cash flow to pay down our debt as we demonstrated in the past. Our plan is to repay approximately $10 billion of debt over the next 2 years to improve our leverage profile.

在過去 3 年裡，我們向股東返還了超過 300 億美元的股息，其中包括連續 15 年增加的股息。如您所知，我們今年將承擔額外債務，以資助我們計劃收購 Karuna 和 RayzeBio。然而，憑藉我們強大的財務狀況，我們計劃利用現金流來償還債務，就像我們過去所展示的那樣。我們的計劃是在未來兩年內償還約 100 億美元的債務，以改善我們的槓桿狀況。

Before turning to our line item guidance, let me close with our 2024 non-GAAP guidance on Slide 20, which includes Mirati, but excludes the future impact of pending transactions, SystImmune, Karuna and RayzeBio. As we did in 2023, we were providing revenue guidance on a reported basis as well as on an underlying basis, which assumes currency remains consistent with prior year. We expect 2024 revenues to increase in a low single-digit range, reflecting our confidence in the growing momentum of our growth portfolio. Excluding foreign exchange, we expect revenues to increase in the low single digit as well.

在介紹我們的專案指引之前，讓我先以投影片 20 上的 2024 年非 GAAP 指引作為結束，其中包括 Mirati，但不包括待定交易、SystImmune、Karuna 和 RayzeBio 的未來影響。正如我們在 2023 年所做的那樣，我們根據報告基礎和基礎提供收入指導，假設貨幣與前一年保持一致。我們預計 2024 年收入將以低個位數成長，這反映了我們對成長組合成長動能的信心。除去外匯，我們預計收入也將以低個位數成長。

Driving our momentum this year, we will be increasing the sales in our growth portfolio from products like Opdivo and our recently launched products. As we said previously, we expect a more modest pace of growth than last year for Opdivo with the potential for acceleration in the back half of the year from new indications. And while our legacy portfolio includes assets that are maturing, we expect strong growth from Eliquis in the U.S. this year. As it relates to quarterly progression of our sales, a few reminders.

為了推動我們今年的發展勢頭，我們將增加 Opdivo 等產品和我們最近推出的產品等成長產品組合的銷售。正如我們之前所說，我們預計 Opdivo 的成長速度將比去年更為溫和，但隨著新適應症的出現，下半年的成長潛力將加速。雖然我們的傳統投資組合包括正在到期的資產，但我們預計今年 Eliquis 在美國將實現強勁成長。由於它與我們銷售的季度進展有關，因此有幾點提醒。

For products like Revlimid, Pomalyst and Camzyos, keep in mind the typical impact on sales in the first quarter due to patients entering the Medicare coverage gap early in the year. And for Eliquis, the coverage gap dynamic works in the opposite direction where we expect sales in the first half of the year to be higher than in the second half. As it relates to our line item guidance for the year, we expect gross margin to be approximately 74%, which reflects an evolution of our sales mix and the nonrecurrence of hedging gains from last year.

對於 Revlimid、Pomalyst 和 Camzyos 等產品，請記住由於患者在年初進入醫療保險覆蓋範圍，這將對第一季的銷售產生典型影響。對於 Eliquis 來說，覆蓋差距的動態則朝著相反的方向發展，我們預計上半年的銷售額將高於下半年。與我們今年的專案指導相關，我們預計毛利率約為 74%，這反映了我們的銷售組合的演變和去年對沖收益的未發生。

Excluding in-process R&D, we expect our total operating expenses to increase in a low single-digit range, reflecting the additional cost of Mirati and the reallocation of costs and efficiency initiatives in MS&A as we continue to invest in our new product launches. This aligns with our previous operating margin target of at least 37%. This means we will remain focused on driving operational efficiencies across the organization including portfolio prioritization to enable us to invest for growth while maintaining high productivity.

除了正在進行的研發外，我們預計總營運費用將在低個位數範圍內成長，這反映了 Mirati 的額外成本以及隨著我們繼續投資於新產品的發布，MS&A 中的成本重新分配和效率舉措。這與我們之前至少 37% 的營業利潤率目標一致。這意味著我們將繼續專注於提高整個組織的營運效率，包括投資組合優先排序，以使我們能夠在保持高生產力的同時進行成長投資。

We expect OI&E to be approximately $250 million of income, reflecting the PD-1 royalty step-down in January from 6.5% to 2.5%, as well as the financing costs related to the Mirati acquisition. We project our tax rate to be approximately 17.5%, reflecting an increase due to nonrecurrence of onetime tax benefit that occurred in the third quarter of last year, plus the anticipated impact of Pillar 2.

我們預計 OI&E 的收入約為 2.5 億美元，反映了 1 月份 PD-1 特許權使用費從 6.5% 降至 2.5% ，以及與 Mirati 收購相關的融資成本。我們預計稅率約為 17.5%，這反映了由於去年第三季一次性稅收優惠不再發生而導致的稅率增長，以及第二支柱的預期影響。

Finally, we expect to deliver non-GAAP earnings per share within the range of $7.10 and $7.40. For clarity, our 2024 guidance excludes the 3 pending transactions. As a reminder, SystImmune is expected to add about $800 million in in-process R&D. Karuna is expected to be about $0.30 dilutive to earnings relating to financing costs as we plan to absorb the OpEx. And RayzeBio would be approximately $0.13 relative to earnings, with half in financing and the other half in OpEx.

最後，我們預期非公認會計準則每股收益在 7.10 美元至 7.40 美元之間。為了清楚起見，我們的 2024 年指引不包括 3 筆未決交易。提醒一下，SystImmune 預計將在正在進行的研發中增加約 8 億美元。由於我們計劃吸收營運支出，預計 Karuna 將對與融資成本相關的收益造成約 0.30 美元的稀釋。而 RayzeBio 相對於收益而言約為 0.13 美元，其中一半用於融資，另一半用於營運支出。

When we report in Q1 in April, we will update our guidance to reflect the deals that have closed at that time. Before we move to the question-and-answer session, I want to thank all of our colleagues around the world for their hard work and dedication in 2023. This is an exciting time for BMS as we write a new chapter and maintain a singular focus on improving our growth profile over the course of the decade. I believe that our focused financial discipline, coupled with strong cash flow generation, are key advantages that will enable us to further diversify our portfolio and invest in growth opportunities to deliver for patients and our investors.

當我們在四月報告第一季時，我們將更新我們的指導方針以反映當時已完成的交易。在進入問答環節之前，我想感謝我們在世界各地的所有同事在 2023 年的辛勤工作和奉獻精神。我相信，我們專注的財務紀律加上強勁的現金流創造是關鍵優勢，這將使我們能夠進一步實現投資組合多樣化並投資於成長機會，從而為患者和投資者提供服務。

I'll now turn the call back over to Tim and Chris for Q&A.

現在我將把電話轉回給蒂姆和克里斯進行問答。

First question, please. But before we do, just a reminder, it's obviously a busy morning for everybody. And to the extent you can keep to just one question so we can get to as many people as possible, we would appreciate that. So let's go to our first rest question, please.

請問第一個問題。但在此之前，我們先提醒一下，對每個人來說，這顯然是一個忙碌的早晨。如果您能只問一個問題，以便我們能夠讓盡可能多的人了解，我們將不勝感激。那我們開始討論第一個休息問題。

The first question will come from Luisa Hector of Berenberg.

第一個問題來自貝倫貝格 (Berenberg) 的 Luisa Hector。

Maybe I'll start with the Abecma because you have the FDA AdCom coming up. So just your level of confidence heading into that. Any comments on how the label changes are impacting or not for all CAR-Ts? And just any pressure that you're seeing from CAR-T4 and how that might evolve in 2024?

也許我會從 Abecma 開始，因為 FDA AdCom 即將舉行。所以這只是你對此的信心程度。關於標籤變化是否對所有 CAR-T 產生影響，您有何評論？您認為 CAR-T4 有何壓力？

First, we'll have Samit answer and then go to Adam.

首先，我們讓薩米特 (Samit) 回答，然後再問亞當 (Adam)。

Thank you, Luisa, for the question. From Abecma perspective, KarMMa-3 data, we've shared updated data at ASH last year. And as you saw, it was very clear what is driving the overall survival curves. It's because of the crossover that the patients have allowance for the progression of their disease on the standard of care arm. And therefore, that curve does benefit, and therefore, you see much of an impact on that overall survival benefit that these patients are getting.

謝謝 Luisa 提出這個問題。從 Abecma 的角度來看，KarMMa-3 數據，我們去年在 ASH 上分享了更新的數據。正如您所看到的，整體生存曲線的推動因素非常明顯。正是由於交叉的存在，患者才能夠在標準治療組中承受病情的進展。因此，該曲線確實有益處，並且您會看到這對這些患者獲得的整體生存益處產生了很大的影響。

We are very confident and we are very much looking forward to having that dialogue and discussion with the regulatory authorities and looking forward to getting this product to the patients as soon as possible. So the second part that you asked about, the label updates that the FDA is seeking right now for all CAR-T products around T cell malignancies. Once again, we've treated thousands of patients. And from our perspective, as we look into our data, we do not see a causative relationship to CAR-T cell therapies in terms of Breyanzi and Abecma. So we'll continue to have the dialogue with the regulators on that as well as we look to the final wording that the FDA will decide. With that, let me pass it on to Adam?

我們非常有信心，非常期待與監管機構進行對話和討論，並期待盡快將產品送到患者手中。您詢問的第二部分是，FDA 目前正在尋求對所有針對 T 細胞惡性腫瘤的 CAR-T 產品進行標籤更新。我們再次救治了數千名患者。從我們的角度來看，當我們查看數據時，我們沒有看到 Breyanzi 和 Abecma 與 CAR-T 細胞療法之間存在因果關係。因此，我們將繼續與監管機構就此進行對話，並期待 FDA 的最終措辭。這樣，我可以把它傳給亞當嗎？

Thanks, Luisa, for the question. So we do expect growth in 2024 for Abecma. KarMMa-3 is a key catalyst for growth this year. And as Samit said, we do look forward to the ODAC to reinforce the benefits of Abecma in a triple exposed patient population.

謝謝 Luisa 提出這個問題。因此，我們確實預計 Abecma 在 2024 年將實現成長。 KarMMa-3 是今年成長的關鍵催化劑。正如薩米特所說，我們確實期待 ODAC 能夠強化 Abecma 在三重暴露患者群體中的益處。

As you can imagine, our commercial teams have been launch-ready for some time, and we're also seeing continued strong international performance. And we'll launch both, Abecma and Breyanzi in a number of new countries this year. We have stated that we've seen continued impact from additional BCMA agents. This is a highly competitive market, putting some pressure on Abecma growth, but our teams are squarely focused on opening new accounts, expanding our site's footprint, not just internationally, but also in the U.S. and closing the gap on efficacy perceptions, including solidifying any misconceptions around Abecma's efficacy and reinforcing Abecma's safety profile, particularly as it relates to CNS neurotoxicity.

你可以想像，我們的商業團隊已經準備好發布一段時間了，我們也看到持續強勁的國際表現。今年，我們將在一些新的國家推出 Abecma 和 Breyanzi。我們已經表示，我們已經看到來自更多 BCMA 代理商的持續影響。這是一個競爭激烈的市場，給 Abecma 的成長帶來了一些壓力，但我們的團隊正專注於開拓新客戶、擴大我們網站的足跡（不僅在國際上，也在美國）並縮小療效認知上的差距，包括鞏固對 Abecma 療效的任何誤解並加強 Abecma 的安全性，特別是與中樞神經毒性相關的安全性。

So taking together, we're confident in Abecma's profile. Looking forward to the ODAC, and I'm confident that we'll be more competitive this year.

綜合來看，我們對 Abecma 的形象充滿信心。期待 ODAC，我相信今年我們的競爭力會更強。

The next question comes from Chris Schott of JPMorgan.

下一個問題來自摩根大通的 Chris Schott。

So maybe a bigger picture question on the new launches. I think those new launches did about $3.6 billion in 2023. And I know you're not giving longer-term targets. But just any just rough framework of how to think about those sales in 2024? I guess is there a target you're providing? If there's not a target, can you maybe just talk a little bit about any areas you see that maybe you're more or less optimistic versus where Street consensus is? I know there's quite a bit of focus on the trajectory of those ramps.

因此，也許關於新產品的發表會有一個更大的問題。我認為這些新產品在 2023 年的營收約為 36 億美元。但是，對於 2024 年的銷售情況，您有沒有什麼粗略的框架可以考慮呢？我猜你提供了一個目標？如果沒有目標，您能否簡單談談您認為與華爾街共識相比您可能更樂觀或更不樂觀的一些領域？我知道人們對這些坡道的軌跡有相當多的關注。

Thanks for the question, Chris. Maybe I'll just start very quickly and then I'll turn it over to Adam. As we had mentioned, we're not going to be providing individual product level guidance, and I think we had alluded to that when we met at JPMorgan 3 weeks ago.

謝謝你的提問，克里斯。也許我很快就會開始，然後再把它交給亞當。正如我們所提到的，我們不會提供單獨的產品等級指導，我認為我們三週前在摩根大通開會時已經提到了這一點。

But we did give and we'll continue to give company line item guidance as we did today. And then you'll see, as we reported today, we're going to be talking additionally about the growth portfolio that we have, which is going to be important as we think about the business going forward. Adam, do you want to talk about the new launches?

但我們確實給出了並將繼續像今天一樣為公司提供分項指導。然後你會看到，正如我們今天報導的那樣，我們將額外討論我們擁有的成長組合，這對於我們考慮未來業務至關重要。亞當，你想談談新產品的發布嗎？

Yes. So thanks for the question, Chris. I mean, we're coming off a good quarter, and we have a strong foundation for growth to build upon. We're focused on continuing to accelerate our new product portfolio and maximizing the 10 launches that we've had over the last 4 years. We're certainly prioritizing the execution of our new launches and adding investment to accelerate the performance of our growth portfolio for products like Camzyos, Sotyktu and Breyanzi.

是的。謝謝你的提問，克里斯。我的意思是，我們剛剛度過了一個良好的季度，並且擁有強大的成長基礎。我們專注於繼續加速我們的新產品組合，並最大限度地發揮過去四年來我們推出的 10 款產品的效果。我們當然會優先推出新產品，並增加投資以加速 Camzyos、Sotyktu 和 Breyanzi 等產品成長組合的表現。

You've also seen strong performance from Reblozyl and Opdualag. We also have some of our growth products like Eliquis and Opdivo, which will continue to contribute significant growth in 2024. And finally, we're readying for the launch of KarXT in September, which we're excited to launch this product, which will be the first new treatment in decades for schizophrenia and also brings a multibillion-dollar opportunity to the organization. So adding it up, that's why we're excited to continue to drive commercial performance in an important 2024.

您還看到了 Reblozyl 和 Opdualag 的強勁表​​現。我們還有一些成長產品，例如 Eliquis 和 Opdivo，它們將在 2024 年繼續貢獻顯著成長。總而言之，這就是為什麼我們很高興在重要的 2024 年繼續推動商業業績。

The next question comes from Chris Shibutani of Goldman Sachs.

下一個問題來自高盛的 Chris Shibutani。

This is Charlie on for Chris. We had a question on the subcutaneous Opdivo strategy for a potential launch there. We heard from one of your competitors yesterday out there. Potential for a subcutaneous CPI where they were considering what sounded like a careful pricing strategy in the context of potential intravenous biosimilars that could be on the market at the same time. So just wondering how you're thinking about pricing on the potential of subcutaneous Opdivo?

這是查理為克里斯上場。我們對在那裡可能推出的皮下 Opdivo 策略有疑問。我們昨天從你們的一個競爭對手那裡聽說了這件事。對於皮下 CPI 的潛力，他們正在考慮一種聽起來像是一種謹慎的定價策略，因為潛在的靜脈生物相似藥可能同時上市。所以只是想知道您如何考慮皮下 Opdivo 的潛力定價？

Adam?

亞當？

Yes. Thanks, Charlie, for the question. So we're not going to comment on the pricing of subcu. But what I can say, we announced positive results of our subcu Opdivo study in the quarter, and we anticipate a launch early next year. As a result, we have the opportunity to potentially benefit thousands of patients well into the next decade with subcu Opdivo.

是的。謝謝查理提出這個問題。所以我們不會對 subcu 的定價發表評論。但我可以說的是，我們在本季宣布了皮下 Opdivo 研究的積極成果，並預計明年初將推出。因此，我們有機會在未來十年透過皮下注射 Opdivo 使數千名患者受益。

I think an important thing to keep in mind. Remember, subcu has the potential to address the treatment burden for both patients and physicians due to less than 5-minute infusion time. And we talked about our ability to convert roughly 30% to 40% of the overall U.S. Opdivo business into subcu. And that's why we would expect to see this franchise endure into the next decade. So we certainly look forward to bringing this important formulation, both to patients and physicians.

我認為這是一件需要牢記的重要事情。請記住，由於輸液時間不到 5 分鐘，皮下注射有可能減輕患者和醫生的治療負擔。我們討論了將美國 Opdivo 整體業務的約 30% 至 40% 轉化為亞克隆的能力。這就是為什麼我們期望這個系列能持續到下一個十年。因此，我們當然期待將這項重要配方帶給患者和醫生。

The next question comes from Andrew Baum of Citi.

下一個問題來自花旗的安德魯鮑姆。

A question for Adam. Have you rethought the use of bridge programs for launches in the U.S. following your Sotyktu experience? And then same topic. Realistically, how long do you think it will be before Sotyktu starts printing revenues through the combination of broader coverage as well as just getting these patients off the bridge?

問亞當一個問題。在經歷了 Sotyktu 火箭發射經歷後，您是否重新考慮在美國使用橋樑計劃進行發射？然後是同一話題。從現實角度來說，您認為 Sotyktu 要花多長時間才能透過擴大覆蓋範圍以及讓這些患者下車來開始創造收入？

Great. Thanks, Andrew. Let me just take the second question first, and then I'll answer as well the bridge question. So Sotyktu is an important brand for the organization, and we are executing against our plan. We shared last year, we're focused on 2 areas. The first is driving demand at the top of the funnel. And the second is securing access and of course, as you mentioned, pulling through those patients from bridge to commercial. And we're making progress against both.

偉大的。謝謝，安德魯。讓我先回答第二個問題，然後我再回答橋樑問題。因此，Sotyktu 是該組織的一個重要品牌，我們正在按照我們的計劃執行。我們去年分享過，我們專注於兩個領域。第一是推動漏斗頂端的需求。第二是確保通道暢通，當然，正如您所提到的，將這些患者從橋樑拉向商業。我們在這兩方面都取得了進展。

You heard from David. When you normalize sales, excluding clinical trial, orders, net sales increased to about 40% versus Q3 and access is critically important in this highly competitive market to drive commercial sales. So we secured ESI and now Cigna in a one-step position. That adds another 40 million lives approximately to complement CVS which represent zero-step position, will continue to be this year and that's approximately 25 million lives.

您聽到了大衛的消息。當您將銷售額標準化（不包括臨床試驗和訂單）時，淨銷售額與第三季相比增長了約 40%，並且在這個競爭激烈的市場中，獲得銷售管道對於推動商業銷售至關重要。因此，我們確保了 ESI 和 Cigna 處於領先地位。這將為另外約 4000 萬人的生命提供補充，以補充代表零步位置的 CVS，今年將繼續如此，這將大約是 2500 萬人的生命。

And we are actively negotiating with other payers and look forward to updating you on additional progress in due course. This year, it's really important to focus on increased paid commercial prescriptions for Sotyktu. We will continue to build volume from both new patients that are going to move directly on to Sotyktu at the specialty pharmacies, which, quite frankly, becomes easier with the improved access that we have now as well as moving patients out of bridge and onto commercial product.

我們正在積極與其他付款人進行談判，並期待在適當的時候向您通報更多進展。今年，真正重要的是專注於增加 Sotyktu 的付費商業處方。我們將繼續增加新患者的用藥量，讓這些患者直接在專科藥房使用 Sotyktu 藥物，坦白說，隨著我們目前藥品管道的改善，這變得更加容易，同時也讓患者脫離了橋樑，轉而使用商業產品。

David talked about where we are today. But in Q1, we expect to see around 10,000 paid prescriptions for Sotyktu. And he also mentioned there will be an increase in gross net due to broader rebating which was needed to secure improved access that impacts net sales in Q1. But we expect to see good momentum in growing our base of paid prescriptions this year, and we plan to get roughly double that level around 20,000 prescriptions in Q4. And that volume momentum will more than offset the gross to net reset in Q1 as the year progresses.

大衛談到了我們今天的狀況。但在第一季度，我們預計 Sotyktu 的付費處方將達到 10,000 份左右。他還提到，由於更廣泛的回扣，總淨銷售額將會增加，而更廣泛的回扣是確保改善管道的必要條件，這將影響第一季的淨銷售額。但我們預計今年付費處方量將呈現良好成長勢頭，我們計劃在第四季度將處方量增加一倍左右，達到 20,000 份左右。而隨著時間的推移，這種銷售成長勢頭將超過第一季的毛銷量與淨銷量之間的重合。

As you also asked around conversion. Conversion is going exactly as we expected. We've made very good progress in shifting patients from CVS from the bridge to commercial product. We talked about taking around 2 to 3 months for patients to move from bridge to commercial. And as a result, you saw that 40% sequential growth that excluded the clinical trial purchases. And so we'll continue to drive demand and work to continue to improve moving patients from our bridge with our ESI and Cigna wins in 2024 and also work to secure improved access in 2025 as well, where it makes financial sense to do so.

正如您所問到的有關轉換的問題。轉換正如我們預期的那樣進行。我們在將患者從 CVS 轉移到商業產品方面取得了非常好的進展。我們談到了患者從橋樑轉為商業化大約需要 2 到 3 個月的時間。結果，您看到了不包括臨床試驗購買在內的 40% 的連續成長。因此，我們將繼續推動需求，並努力透過 2024 年 ESI 和 Cigna 的勝利繼續改善從我們的橋樑轉移的患者，同時也努力確保在 2025 年改善訪問，這樣做具有財務意義。

The next question comes from Seamus Fernandez of Guggenheim Securities.

下一個問題來自古根漢證券的 Seamus Fernandez。

So just a quick one here. On Reblozyl, the continued strength of the brand and the acceleration that we're starting to see. Can you just talk about what's driving that incrementally? And maybe give us a little bit of a sense of how we should be thinking about the international opportunity for Reblozyl in particular?

這裡就簡單說一下。對於 Reblozyl 來說，我們開始看到品牌的持續實力和加速發展。您能否談一談推動這項進程的因素是什麼？也許您可以讓我們稍微了解一下我們應該如何看待 Reblozyl 的國際機會？

Adam?

亞當？

Yes, Seamus, thanks for the question. The first-line MDS launch is progressing very well in the U.S. with strong demand supported by our broad label in an RS-agnostic patient population. Just take you back, we launched in late August. And initially after the launch, we saw rapid switches from ESAs to Reblozyl. But we're now seeing strength in first-line use across RS-positive population, and we're steadily building momentum in the RS-negative patient population, particularly in the community setting where the majority of patients are treated.

是的，Seamus，謝謝你的提問。一線 MDS 藥物在美國的上市進展非常順利，我們廣泛的標籤在 RS 不可知論患者群體中支持了強勁的需求。回顧一下，我們是在 8 月底推出的。在推出後不久，我們看到從 ESA 到 Reblozyl 的快速轉變。但現在我們看到 RS 陽性人群中一線使用情況的增強，並且我們正在 RS 陰性患者群體中穩步建立勢頭，特別是在大多數患者接受治療的社區環境中。

We also have -- after the ASH presentation, we've heard feedback from both academic and community physicians recognizing the durability of response and the ability to remain transfusion independent as key features of the brand. So we're very pleased with the launch as we're seeing strong sales performance, we expect that to continue this year. And Reblozyl was also approved in Japan in mid-January. We're seeing nice uptake there, and we expect European approval in the first half of this year.

在 ASH 演示之後，我們也聽取了學術和社區醫生的回饋，他們認識到反應的持久性和保持輸血獨立的能力是品牌的主要特徵。因此，我們對新產品的發布感到非常高興，因為我們看到了強勁的銷售業績，我們預計今年這種勢頭將持續下去。而Reblozyl也於1月中旬在日本獲得批准。我們看到了那裡良好的發展勢頭，預計今年上半年將獲得歐洲批准。

The next question comes from Tim Anderson of Wolfe Research.

下一個問題來自 Wolfe Research 的蒂姆·安德森。

On Sotyktu, I think it was at Q3, you mentioned it would take longer to get no step edits. So I'm wondering what the current step edits are exactly, what brands do patients have to step through? Is it Otezla primarily? Or is it Humira, either brand or biosimilar or what exactly?

在 Sotyktu 上，我認為是在 Q3，您提到要花更長時間才能獲得無步驟編輯。所以我想知道目前的步驟編輯到底是什麼，患者必須經歷哪些品牌？主要是 Otezla 嗎？或是 Humira，無論是品牌藥還是生物相似藥，或者到底是什麼？

Yes, Tim, thank you. So as I mentioned, we secured additional access at ESI and now Cigna in a one-step position. And so that really is regardless of the product. So that could be a step after Otezla, it could be a step after IL-17s or the IL-23 agents in the market, but what's important is that, that adds another 40 million lives to complement our zero-step adds in CVS. So taking together that's 65 million lives today, and we're continuing to actively negotiate with payers, and we will update you on additional progress over the coming months.

是的，提姆，謝謝你。正如我所提到的那樣，我們獲得了 ESI 的額外存取權限，現在 Cigna 處於一步之遙的位置。所以這確實與產品無關。因此，這可能是繼 Otezla 之後的一步，可能是繼市場上的 IL-17 或 IL-23 藥物之後的一步，但重要的是，這又增加了 4000 萬人的生命，以補充我們在 CVS 中的零步添加。所以今天總共有 6500 萬人的生命，我們正在繼續積極與付款人進行談判，並將在未來幾個月內向您通報更多進展。

The next question comes from Trung Huynh of UBS.

下一個問題來自瑞銀的 Trung Huynh。

Just on IRA, I realize there's not much you can say about the negotiation where I think CMS has just sent their initial offer. But I was wondering about more -- how do you think about the impact? So for Eliquis, given the patient mix is largely skewed towards Medicare, do you think there could be a potential uplift that could help offset that pricing erosion? And how do you anticipate the commercial spillover from those pricing impacts?

僅就 IRA 而言，我意識到關於談判你能說的並不多，我認為 CMS 剛剛發送了他們的初始報價。但我想了解更多—您如何看待其影響？那麼對於 Eliquis 而言，考慮到患者結構很大程度上偏向醫療保險，您是否認為可能存在潛在的提升，從而有助於抵消價格下滑？您如何預測這些定價影響將帶來的商業外溢效應？

Yes. Thanks for the question. I'll take that. So as it relates to IRA, we do expect an improvement in patient affordability as the patient out-of-pocket changes for patients this year and in the next. We will see this more acutely next year as out-of-pocket max is kept at $2,000 and then patients had 0% liability thereafter. So more broadly though, we largely don't expect Medicare-party design changes to impact our portfolio because that will largely take effect in 2026 when branded Revlimid will be fully eroded. As it relates to commercial spillover, I think it's important that we always look at multiple planning scenarios including the risk of spillover, but also the potential opportunity, as I just shared around patient affordability.

是的。謝謝你的提問。我接受。因此，就 IRA 而言，隨著今年和明年患者自付費用的變化，我們確實預計患者的負擔能力會有所改善。明年我們將更清楚地看到這一點，因為自付費用最高限額將保持在 2,000 美元，此後患者的責任為 0%。因此，從更廣泛的角度來看，我們基本上不認為醫療保險方案的設計變化會影響我們的投資組合，因為這將主要在 2026 年生效，屆時品牌 Revlimid 將完全消失。就商業外溢效應而言，我認為重要的是我們始終要考慮多種規劃方案，包括溢出風險，也包括潛在的機會，正如我剛才分享的有關患者負擔能力的因素。

So there are pushes and pulls there with changes in the benefit design. We are going to have to continue to manage potential spillover risk to commercial with the transparency of the MFP price on September 1. But we also do that today as we manage both books of business, and we'll need to continue to remain disciplined across our commercial payers. And at the same time, just because the payer wants to include this in negotiating mix in commercial, it certainly doesn't mean that we have to agree there. So we expect continued strong performance this year for Eliquis in the U.S. and expect significant growth through the end of 2025.

因此，福利設計的變化存在著推拉因素。我們將不得不繼續管理 9 月 1 日 MFP 價格透明度對商業的潛在溢出風險。 但今天我們管理兩份業務帳簿時也會這樣做，我們需要繼續對商業付款人保持紀律。同時，僅僅因為付款人希望將其納入商業談判組合中，並不意味著我們必須同意。因此，我們預計 Eliquis 今年在美國將繼續表現強勁，並預計在 2025 年底實現顯著成長。

The next question comes from Geoff Meacham of Bank of America.

下一個問題來自美國銀行的傑夫‧米查姆。

Chris or David, on capital allocation, you guys have some deals closing, obviously, in the first half of this year. But would you say the balance of the year is more of a pause on deals with the focus on integration? Or would bolt-on still be of interest? I'm just trying to get a sense with all the launches operationally and whether newer products or more products and integration could be a distraction to what you're doing commercially?

克里斯或大衛，在資本配置方面，你們顯然在今年上半年完成了一些交易。但您是否認為今年餘下的時間將暫停一些交易並將重點放在整合上？或者螺栓固定仍然有趣嗎？我只是想要從營運角度了解所有發布的產品以及更新的產品或更多的產品和整合是否會分散您對商業活動的注意力？

Thanks for the question, Geoff. I'll take that one. So as we've discussed previously, as we think about capital allocation, business development continues to be a top priority for us. Obviously, we've just executed a number of deals towards the end of last year, and we've got to stay focused on executing those deals.

謝謝你的提問，傑夫。我要那個。正如我們之前討論過的，當我們考慮資本配置時，業務發展仍然是我們的首要任務。顯然，我們在去年年底剛剛執行了一些交易，我們必須專注於執行這些交易。

Having said that, we certainly are going to continue to be interested in bringing innovation into the company that makes strategic and financial sense to do so. I would characterize those a bit more as bolt-on opportunities. At this point, we're also, of course, continuing to look at partnerships and licensing deals as well. But that's how I would characterize it. Business development is still a priority.

話雖如此，我們肯定會繼續有興趣為公司帶來具有策略和財務意義的創新。我更願意把它們描述為附加機會。此時，我們當然也持續尋找合作夥伴關係和授權協議。但這就是我對它的描述。業務發展仍是首要任務。

The next question comes from Matt Phipps of William Blair.

下一個問題來自 William Blair 的 Matt Phipps。

Samit, I was wondering if you could give us a sense of how many SLE patients do you expect to treat with the NEX-T CAR-T program this year? And is the next step after this Phase I study straight to pivotal? Do you have a sense yet of what that looks like?

Samit，我想知道您能否告訴我們，您預計今年將使用 NEX-T CAR-T 計畫治療多少 SLE 患者？第一階段研究後的下一步是否至關重要？您是否已經感覺到它看起來是什麼樣子了？

Yes. Thank you for the question, Matt. Look, we are in the dose escalation phase. As you can recall, we have to go through one patient by one patient in the beginning. But very soon, we'll be able to treat a number of patients at the same time. I can't give you a number in terms of how many patients we intend to treat at this time, but certainly, the trials will remain open as we want to certainly get a good understanding of the efficacy and safety profile at the right dose for patients with SLE who have advanced disease.

是的。謝謝你的提問，馬特。你看，我們正處於劑量遞增階段。您可能還記得，一開始我們必須逐一檢查一位患者。但很快，我們就能同時治療多位患者了。我目前無法給出我們打算治療的患者人數，但可以肯定的是，試驗將繼續進行，因為我們想充分了解適合晚期 SLE 患者的劑量的療效和安全性。

We do intend to present the data later this year, emerging from the first trial. In terms of what the next steps would be, we will be engaging with some data in hand with the regulatory agencies in terms of defining what the trial should look like. In this particular case, with a single-arm open-label study such as been done with hematological malignancies, will that be the acceptable approach? Or will the regulators require a randomized approach? Those are yet to come. But certainly, looking forward to the emergence of this data and presenting that later in the year.

我們確實打算在今年稍後公佈第一次試驗的數據。對於下一步的行動，我們將與監管機構合作，根據手頭上的一些數據來確定試驗的具體內容。在這種特殊情況下，採用單臂開放標籤研究（例如對血液系統惡性腫瘤進行的試驗）是否是可接受的方法？或者監管機構是否要求採用隨機方法？這些都還未到來。但可以肯定的是，我們期待這些數據的出現並在今年稍後呈現。

The next question comes from Steve Scala of TD Cowen.

下一個問題來自 TD Cowen 的 Steve Scala。

I believe Milvexian's AFib trial right around now is at the point where Bayer stopped its Factor XI AFib trial. Can you reassure us that events in the Milvexian AFib trial are progressing as expected? And Samit, based on everything you know, are you very confident in Milvexian and AFib. The trial has been underway for approaching a year, so I would imagine some sort of look has already been taken.

我認為 Milvexian 現在的 AFib 試驗正處於拜耳停止其 XI 因子 AFib 試驗的階段。您能向我們保證 Milvexian AFib 試驗的進展符合預期嗎？薩米特，根據您所了解的一切，您對 Milvexian 和 AFib 非常有信心嗎？該審判已進行了將近一年，所以我想已經採取了某種措施。

Samit?

薩米特？

Thank you, Steve, for the question. Very thoughtful, as always. What we can tell you is the trial is continuously progressing. On all 3 trials, AF, secondary stroke prevention and ACS, enrollment is going very well. And certainly, the DMC continues to oversee the trials, and we do not have any indication from the DMC otherwise.

謝謝史蒂夫提問。一如既往，非常周到。我們可以告訴你的是，試驗正在不斷進展。所有 3 項試驗（AF、二級中風預防和 ACS）的招募進展都很順利。當然，DMC 會繼續監督審判，而且我們也沒有從 DMC 得到任何相反的跡象。

We will continue to look at the data from a perspective of safety as well as the DMC will continue to look at the data. There's nothing more to report at this time. I would say one thing, though, that assuming just because a competitor trial failed for whatever reasons and the doses that they picked, we don't have that same philosophy. We actually did conduct 2 very well-designed studies. We picked differential doses between atrial fibrillation versus SSP and ACS, and those are the reasons to believe, and we will certainly be looking forward to the readout of these trials in '26 and '27.

我們將繼續從安全的角度查看數據，並且 DMC 也將繼續查看數據。目前還沒有更多值得報告的消息。不過，我想說的是，僅僅因為競爭對手的試驗因某種原因和他們選擇的劑量而失敗，我們就不會抱持同樣的理念。我們確實進行了兩項設計非常精良的研究。我們選擇了心房顫動與SSP和ACS之間的差異劑量，這些是值得相信的理由，我們當然期待在'26年和'27年這些試驗的讀數。

The next question comes from Terence Flynn of Morgan Stanley.

下一個問題來自摩根士丹利的特倫斯·弗林（Terence Flynn）。

I was just wondering if you could elaborate on your thoughts on Breyanzi commercial potential this year, particularly in the second-line setting and how the final OS data might impact that? And then anything you're seeing with respect to outpatient treatment for Breyanzi here?

我只是想知道您是否可以詳細闡述您對今年 Breyanzi 商業潛力的看法，特別是在二線環境中，以及最終的 OS 數據將如何影響這一點？那麼，您對 Breyanzi 的門診治療有何看法？

Adam and Samit?

亞當和薩米特？

Yes, certainly. Thank you. So I'll start off and then pass it on. R&D comes first before commercial. So I'll start off with Breyanzi. Certainly looking forward to these 3 PDUFA dates that Adam had mentioned earlier as well as David in his remarks for follicular lymphoma, mantle cell lymphoma and CLL. And then, of course, we are planning to do few more trials in these lymphoma patients because that remains a very high unmet medical need.

是的，當然。謝謝。因此我將開始並傳遞它。研發優先，商業優先。因此，我先從 Breyanzi 開始。當然，期待 Adam 之前提到的 3 個 PDUFA 日期以及 David 在關於濾泡性淋巴瘤、套細胞淋巴瘤和 CLL 的評論中提到的這 3 個 PDUFA 日期。當然，我們計劃對這些淋巴瘤患者進行更多的試驗，因為這仍然是一個非常高的未滿足的醫療需求。

And then, of course, there are multiple other cell therapy products that are in development. So we'll be talking more about that. From the out-of-spec or the continuation of those discussions, we continue to engage with the regulatory authorities and we'll update at a later date once we have an inkling in terms of where we are landing on that. Adam?

當然，還有多種其他細胞治療產品正在開發中。因此我們將會進一步討論這個問題。從超出規格或繼續討論的角度來看，我們將繼續與監管機構接觸，一旦我們對此有了初步了解，我們將在稍後更新。亞當？

Yes. Thanks for the question. So we're pleased with Breyanzi's performance in the quarter. We saw double-digit growth quarter-on-quarter. We also expect to continue to make good progress in Breyanzi in 2024, supported by strengthening of our vector supply. In fact, we will see supply materialize even further in Q2 and expand to support our new indications for Breyanzi starting with the planned CLL indication in March, where Breyanzi will be the first and only cell therapy agent to have this indication.

是的。謝謝你的提問。因此，我們對 Breyanzi 本季的表現感到滿意。我們看到了季度環比兩位數的成長。我們也預計，在加強載體供應的支持下，2024 年 Breyanzi 將繼續取得良好進展。事實上，我們將在第二季度看到供應進一步實現，並擴大以支持 Breyanzi 的新適應症，從 3 月計劃的 CLL 適應症開始，Breyanzi 將是第一個也是唯一一個具有此適應症的細胞治療藥物。

As Samit alluded to, we're making good progress in reducing turnaround time out of spec in drug product capacity. So now as we move through the course of the first half of the year, with this brought label and LBCL, and now with 3 FDA priority reviews in the first half of the year, Breyanzi has the potential to treat the broadest array of B-cell malignancies of any CAR-T. And these indications we believe will double the addressable patient population for Breyanzi. So we're very pleased with what we're seeing and the progress that we're making. We are seeing increases in outpatient use because of the best-in-class safety profile that Breyanzi brings, and we expect strong demand growth this year.

正如薩米特所提到的，我們在減少藥品產能不合格週轉時間方面取得了良好進展。因此，現在，隨著我們進入上半年，憑藉這一標籤和 LBCL，以及上半年 FDA 的 3 項優先審查，Breyanzi 有可能治療任何 CAR-T 中最廣泛的 B 細胞惡性腫瘤。我們相信這些適應症將使 Breyanzi 的目標患者數量增加一倍。因此，我們對所看到的和所取得的進展感到非常高興。由於 Breyanzi 具有一流的安全性，我們看到門診使用量增加，我們預計今年的需求將強勁成長。

The next question comes from Evan Seigerman of BMO Capital Markets.

下一個問題來自 BMO 資本市場的 Evan Seigerman。

So last week, you presented initial data from your antigen receptor ligand direct integrator at ASCO GU, then hosted an event for the cell side. I'd love for you to speak to why you think it's important for investors and analysts to pay attention to a Phase 1 asset at a company as large as Bristol-Myers? I know you have a lot going on in your pipeline. So why should we be focused on things like this?

所以上週，您在 ASCO GU 上展示了抗原受體配體直接整合劑的初始數據，然後主持了一場細胞方面的活動。我很想請您談談，為什麼您認為投資人和分析師關注百時美施貴寶這樣大的公司的第一階段資產很重要？我知道你有很多事情要做。那我們為什麼要關注這樣的事情呢？

Samit, we'll start and then we'll turn it to Adam to get some feedback from KOLs on this product.

Samit，我們先開始，然後我們將把話題轉到 Adam，以獲取一些 KOL 對該產品的反饋。

Thank you, Evan. I think it's a good question. And the reason we believe that it is important for us to be able to highlight this are multifold. Let me start off by saying, remember last year at the R&D Day, we had said that there are 2 platforms that are very critical and we believe in, and we are continuing to progress on them. AR-LDD, the molecule is the first protein degrader from that platform that goes into solid tumors, and we wanted to absolutely be able to demonstrate that it is as we anticipated it progressing well showing efficacy and manageable safety profile in patients with late-line prostate cancer.

謝謝你，埃文。我認為這是個好問題。我們認為強調這一點很重要，原因有很多面向。首先我要說的是，記得去年在研發日上，我們曾說過有兩個平台非常重要，我們相信它們，而且我們正在繼續推進它們。 AR-LDD 是該平台上第一個能夠進入實體腫瘤的蛋白質降解劑，我們希望能夠證明它正如我們預期的那樣，在晚期前列腺癌患者中進展良好，顯示出療效和可控的安全性。

As you saw from the data, the PSA30, PSA50 reductions, the durability of that and those are truly correlated if you look at the data set as well as in literature, the correlation of that impacting the overall survival. So we are truly excited about what we've seen thus far. We are, of course, enrolling more patients. We are in the dose optimization phase. We've had interactions with regulatory authorities and now planning for initiating the next phase of development registration trials within the next 6 to 12 months. Let me just pass it over to Adam to comment further from his perspective as well.

從數據中可以看出，PSA30、PSA50 的減少、其持久性以及它們是真正相關的，如果您查看數據集以及文獻，您會發現它們的相關性影響了整體生存率。因此，我們對目前所見的一切感到非常興奮。當然，我們正在招募更多的患者。我們正處於劑量優化階段。我們已經與監管機構進行了互動，目前計劃在未來 6 到 12 個月內啟動下一階段的開發註冊試驗。讓我將其交給亞當，讓他從他的角度進一步評論。

Yes. Thanks, Samit. Evan, thanks for the question. So we're excited about, as Samit said, the platform of protein degradation. And as it relates to AR-LDD, in prostate cancer, this diversifies our IO portfolio even further to complement some of the recent deals.

是的。謝謝，薩米特。埃文，謝謝你的提問。正如薩米特所說，我們對蛋白質降解平台感到非常興奮。並且由於它與前列腺癌的 AR-LDD 相關，這使我們的 IO 產品組合更加多樣化，以補充最近的一些交易。

We had a number of KOL and community feedback coming out of the ASCO GU presentation and PLs have been enthusiastic about the profile, particularly around the efficacy of the asset, the durability of response. And when we ask community positions, they were reassured around the safety profile as well, stating that it was a manageable safety profile, and they were enthusiastic about moving this into Phase III registrational studies and look forward to have the opportunity to treat patients with late-line prostate cancer.

我們收到了許多來自 ASCO GU 演示的 KOL 和社群回饋，PL 對該簡介非常感興趣，特別是在資產的功效和回應的持久性方面。當我們詢問社區立場時，他們也對安全性感到放心，指出這是一個可控的安全性，他們熱衷於將其轉移到 III 期註冊研究，並期待有機會治療晚期前列腺癌患者。

The next question comes from Carter Gould of Barclays.

下一個問題來自巴克萊銀行的卡特·古爾德。

For Adam, I wanted to come back to Camzyos. You sort of have shown a pretty steady kind of addition of sort of the same number of patients for each quarter. I would expect sort of now that you've gotten your feet under -- with the launch that, that number would be increasing sort of each quarter like we see with most launches, which I guess suggest there's some other sort of gating factor, whether that's logistics or whatnot. Can you maybe elaborate on what you're seeing and whether you disagree or agree with kind of how I frame that there? And to whatever extent you can comment on the trends going forward in '24?

為了亞當，我想回到卡姆札奧斯。您已經顯示出每季度患者數量的穩定增加。我希望現在你已經站穩腳跟 - 隨著產品的發布，這個數字會像我們在大多數產品發布中看到的那樣每個季度都在增加，我想這表明還存在一些其他的限制因素，無論是物流還是其他什麼。您能否詳細說明您所看到的，以及您是否同意或不同意我對此的描述？您能對 24 年未來的趨勢做出何種程度的評論嗎？

Adam?

亞當？

Sure, Carter. Thanks for the question. So we continue to make very good progress with Camzyos. As we talked about, we're investing further behind the brand in unbranded and branded direct-to-consumer. We do expect to see continued steady and consistent growth. As David mentioned in his opening remarks, we're averaging around 1,000 patients on a quarterly basis. Patient and physician feedback continue to be very positive. Remember, these patients are going to be on treatment for a very long time.

當然，卡特。謝謝你的提問。因此，我們在 Camzyos 方面繼續取得了非常好的進展。正如我們所談到的，我們正在對非品牌和品牌直接面向消費者的產品進行進一步的投資。我們確實希望看到持續穩定、持續的成長。正如 David 在開幕詞中提到的，我們每季平均接待約 1,000 名患者。患者和醫生的回饋仍然非常積極。請記住，這些患者將接受長期治療。

And taking you back to JPMorgan. If you recall, Chris showed an analog where Camzyos is tracking into a very strong CV launch, in this case, ENTRESTO. So this is the way that cardiovascular launches uptake. And we are focused on continuing to drive breadth in our top COEs. We'll continue to expand outside of our top COEs and we're working to increase diagnosis rates by activating patients via our new DTC advertising. So that, coupled with new launches internationally, we are confident that this is going to lead to continued and sustained growth for this important brand.

讓我們回到摩根大通。如果你還記得的話，克里斯展示了一個類比，其中 Camzyos 正在追蹤一個非常強勁的 CV 發布，在本例中就是 ENTRESTO。這就是心血管啟動吸收的方式。我們致力於繼續擴大我們頂級 COE 的廣度。我們將繼續在頂級 COE 之外擴張，並致力於透過新的 DTC 廣告激活患者來提高診斷率。因此，加上在國際上推出的新產品，我們相信這將為這個重要品牌帶來持續的成長。

The next question comes from Mohit Bansal of Wells Fargo.

下一個問題來自富國銀行的 Mohit Bansal。

This is Serena on for Mohit Bansal. So I wanted to ask about the Phase II Opdualag readout coming out early this year in first-line lung cancer. I was wondering how meaningful you think this data could be considering that the comparator arm is Opdivo chemo versus Opdivo Yervoy being the approved regimen?

這是小威 (Serena) 取代莫希特班薩爾 (Mohit Bansal)。所以我想詢問一下今年早些時候在一線肺癌治療中推出的 II 期 Opdualag 試驗的讀數。我想知道，考慮到對照組是 Opdivo 化療，而 Opdivo Yervoy 是獲得批准的方案，您認為這些數據有多大意義？

Samit?

薩米特？

Thank you for the question. Obviously, we're looking forward to seeing the data for Opdualag, a randomized Phase II study looking at the combination of Opdivo relatlimab plus chemotherapy comparing to Opdivo chemo. The intent of doing this is twofold. One, we wanted to get the contribution of component question out right away so that we can show the contribution of relatlimab on top of Opdivo with chemotherapy.

感謝您的提問。顯然，我們期待看到 Opdualag 的數據，這是一項隨機 II 期研究，對比了 Opdivo relatlimab 聯合化療與 Opdivo 化療。這樣做的目的有兩個。首先，我們希望立即得出組成問題的貢獻，以便我們能夠展示 relatlimab 在 Opdivo 化療基礎上的貢獻。

And number two, we also wanted to plan this study so that we can -- when we do go to Phase III, the appropriate control arm that is most widely used right now is pembro chemo. And therefore, we are set for that, dependent, of course, on the data. So later this quarter and this year, you will be able to hear about the data. And then based on the data, we will be making decisions on where to go with this drug.

第二，我們也希望規劃這項研究，以便我們能夠—當我們進入第三階段時，目前最廣泛使用的適當對照組是派姆單抗化療。因此，我們已經為此做好了準備，當然，這取決於數據。因此，本季晚些時候和今年，您將能夠聽到有關數據的消息。然後根據數據，我們將會決定如何使用這種藥物。

The next question comes from Robyn Karnauskas of Truist Securities.

下一個問題來自 Truist Securities 的 Robyn Karnauskas。

This is Srikripa on for Robyn. I have a follow-up question on Camzyos. Just wondering if you can talk a little bit about how you think the recent data from a competitor might broadly impact the landscape in ACM. Obviously, the drug is not approved yet, but do you see these data improving awareness? And based on that, do you expect to see any sort of inflection points? And also, can you talk a little bit more about your efforts ex U.S. and if we should continue to see steady growth or any sort of inflection point based on the reimbursements that you expect?

這是 Srikripa 為 Robyn 表演的。我有一個關於 Camzyos 的後續問題。我只是想知道您是否可以稍微談談您認為競爭對手的最新數據可能會對 ACM 的格局產生怎樣的廣泛影響。顯然，該藥物尚未獲得批准，但您是否認為這些數據可以提高人們的意識？基於此，您是否預計會看到任何轉折點？另外，您能否再談談您在美國以外的努力，以及我們是否應該繼續看到穩定的成長或根據您預期的報銷出現任何形式的轉折點？

Samit and Adam?

薩米特和亞當？

Yes. Thank you for the questions. The way we would look at it is that the competitor data actually further strengthens our confidence in Camzyos. And within the Camzyos clinical trials, we now have 3 Phase III trials that are readout with amazing transformational data.

是的。感謝您的提問。我們的看法是，競爭對手的數據實際上進一步增強了我們對 Camzyos 的信心。在 Camzyos 臨床試驗中，我們現在進行了 3 個 III 期試驗，並讀取了令人驚嘆的轉化數據。

You've seen the data for EXPLORER, you've seen the data from VALOR, and recently, we had the readout of a Phase III trial in Japan as well, which replicates the results that we've already seen for the first 2 trials. As Adam would tell you, we've treated now thousands of patients, and that data also continues to showcase the efficacy of the drug as well as maintains the safety of the drug. As you will see when the data are presented from the real-world setting at ACC, what the overall safety profile of the drug is. So in general, what I would say is profile of the drug is. So in general, what I would say is that Camzyos lives up to its promise of a transformational potential for the patients. And any patient who goes on the drug, usually doesn't want to come off because of the benefit that they are achieving. Adam?

您已經看到了 EXPLORER 的數據，看到了 VALOR 的數據，最近，我們還在日本進行了第三階段試驗，該試驗複製了我們在前兩次試驗中看到的結果。正如亞當所說，我們現在已經治療了數千名患者，這些數據也繼續展示了該藥物的有效性並確保了藥物的安全性。當 ACC 的真實世界環境中呈現數據時，您會看到該藥物的整體安全性如何。所以總的來說，我想說的是這種藥物的概況。所以總的來說，我想說的是 Camzyos 履行了為患者帶來轉變潛力的承諾。任何服用該藥物的患者通常都不願意停藥，因為他們已經獲得了益處。亞當？

Yes. Thanks for the question. So certainly, when we look at the top line data from Sequoia is consistent with our internal expectations. We'll obviously need to see the data set. But ultimately, we don't see any clinically meaningful differences in the data. In fact, when we spoke to many TLs after those data were shared, they have stated that aficamten data appears similar and undifferentiated from Camzyos. They also, of course, want to see the broad data set. They also talked about the difference in pVO2 being not a clinically meaningful endpoint and likely those -- any differences are due to differences in patient populations across the 2 studies.

是的。謝謝你的提問。因此，當然，當我們查看紅杉資本的營收數據時，它是與我們的內部預期一致的。我們顯然需要查看資料集。但最終，我們沒有看到數據中任何具有臨床意義的差異。事實上，在這些資料共享之後，當我們與許多 TL 交談時，他們表示 aficamten 資料看起來與 Camzyos 相似且沒有區別。當然，他們也希望看到廣泛的數據集。他們也談到，pVO2 的差異並不是一個具有臨床意義的終點，而任何差異很可能是由於兩項研究中患者群體的差異所造成的。

Actually, we will certainly be prepared for aficamten when it comes to market with our leading cardiovascular organization. And we have maintained a consistent view that we will remain leaders in this space. I've also said though that important thing to keep in mind with this class is we do see that another competitor, it could be a net positive to help drive awareness for patients with symptomatic oHCM and increased diagnosis rates, which is also really important.

事實上，當 aficamten 與我們領先的心血管組織一起進入市場時，我們一定會做好準備。我們始終堅信我們將繼續在該領域保持領先地位。我也說過，不過，參加這門課程需要牢記的重要一點是，我們確實看到了另一個競爭對手，這可能會帶來積極影響，有助於提高有症狀的 oHCM 患者的認識並提高診斷率，這也非常重要。

Finally, as it relates to expansion outside of the U.S., we're just starting to see expansion outside of the U.S. We've launched in Germany. We'll prepare to launch in Japan, in China in midyear and a host of other markets. So we'll start to see those sales manifest in the back end of the year and into 2025.

最後，就美國以外的擴張而言，我們才剛開始看到美國以外的擴張。我們將準備在日本、年中在中國以及其他一系列市場推出該產品。因此，我們將在今年年底和 2025 年開始看到這些銷售業績。

The next question comes from James Shin of Deutsche Bank.

下一個問題來自德意志銀行的 James Shin。

Just wanted to circle back on Zeposia. Adam, I think you mentioned earlier or late last year, the access was still improving for UC. Is that access going to improve meaningfully this year? Or is it going to take a little bit more time, sort of like a similar situation to Sotyktu and psoriasis?

只是想回到 Zeposia。亞當，我想你提到過，去年早些時候或年末，UC 的訪問仍在改善。今年這種訪問方式是否會有顯著改善？或者是否需要更多時間，有點像 Sotyktu 和牛皮癬的情況？

Yes. Thanks for the question. So overall, we're seeing solid and continued quarterly and year-on-year growth. As David shared, we showed 66% growth versus prior year. I think Zeposia has been really a tale of 2 launches. MS performance amongst the oral competitors is solid. We expect continued share growth there. And we're growing in the face of a declining oral market in favor of B-cell agents.

是的。謝謝你的提問。總體而言，我們看到季度和年度的穩健和持續成長。正如 David 所說，我們比去年同期成長了 66%。我認為 Zeposia 實際上是兩次發布的故事。在口語表達能力方面，MS 的表現非常出色。我們預計該份額將繼續增長。在口服藥物市場逐漸衰退、B 細胞藥物市場逐漸受到青睞的背景下，我們仍在不斷發展。

We continue to have an opportunity for continued growth in UC, which, as you know, is a very competitive market. We're making progress as volume and share are increasing. We are focused on expanding the breadth of prescribers. We're continuing to position Zeposia earlier in lines of treatment. And the opportunity for additional indications like Crohn's disease, the data readout later this year will also add to the sales for Zeposia. So again, we do expect to see continued growth for Zeposia as patients continue to accumulate and physicians continue to gain experience with the product.

我們仍然有機會在 UC 中繼續成長，正如你所知，這是一個競爭非常激烈的市場。隨著數量和份額的增加，我們正在取得進步。我們致力於擴大處方人員的廣度。我們將繼續將 Zeposia 定位於治療的早期階段。此外，克羅恩病等其他適應症的機會以及今年稍後公佈的數據也將增加 Zeposia 的銷售量。因此，隨著患者數量的不斷積累和醫生對產品經驗的不斷積累，我們確實預計 Zeposia 將繼續增長。

Great. And maybe time for 1 or 2 more. Maybe we'll go to the next question for now and then 1 after that, Andrea.

偉大的。也許還有時間再做 1 或 2 次。也許我們現在可以先討論下一個問題，然後再討論下一個問題，安德里亞。

Okay. The next question is from Akash Tewari of Jefferies.

好的。下一個問題來自 Jefferies 的 Akash Tewari。

Can you comment on what drives your confidence on the Alzheimer's psychosis reading out positively? Any color on what percent of patients you think will be able to get on the high dose of KarXT? And what percent of dropouts do you think will occur in the treatment arms through these ADEPT trials? Should it be roughly similar to what we've seen in the schizophrenia studies?

您能否評論一下是什麼促使您對阿茲海默症精神病的解讀充滿信心？您認為有多少比例的患者能夠服用高劑量的 KarXT？您認為透過這些 ADEPT 試驗，治療組中退出試驗的人數將佔多少百分比？它應該與我們在精神分裂症研究中看到的大致相似嗎？

Samit?

薩米特？

Thank you for the question, Akash. Look, our confidence in -- remains very high. And the reason for that is if you go back to the first publications of the xanomeline trial, that was a study that was published, I think, in 1997, in fact. And if you look at that data, there was a positive trial, which tells us that M1/M4 muscarinic receptor agonist do work over there. The obvious issue over there was the toxicity due to the peripheral muscarinic agonism that was seen. So that combination with trospium has led to obviously better outcomes as we saw in schizophrenia.

謝謝你的提問，阿卡什。瞧，我們的信心仍然很高。原因在於，如果您回顧 xanomeline 試驗的首次發表，那是一項於 1997 年發表的研究。如果你查看這些數據，你會發現有一個積極的試驗，這告訴我們 M1/M4 毒蕈鹼受體激動劑在那裡確實有效。這裡明顯的問題是由於觀察到的外周毒蕈鹼激動作用而產生的毒性。因此，正如我們在精神分裂症治療中看到的那樣，與曲司氯胺酮的結合顯然取得了更好的療效。

The trial in AD psychosis is right now at the beginning stages. So the doses are being tested right now. So it's hard to comment on what the dose utilization would be, where the patients will be on the highest doses, it's too early to tell. We'll have to get into it. But of course, Karuna and us, we continue to operate as separate companies right now. And once the transaction closes, then we'll be able to get deeper into it and look at what the future looks like. So we'll be talking about it at a later date.

對 AD 精神病的試驗目前正處於開始階段。因此現在正在測試劑量。因此，很難評論劑量利用率是多少，患者將服用最高劑量，現在還為時過早。我們必須深入研究它。但當然，Karuna 和我們現在繼續作為獨立的公司運作。一旦交易完成，我們就能深入了解並展望未來。因此我們將稍後再討論此問題。

Let's go to our last one, please, Andrea.

安德里亞，我們進入最後一個環節吧。

The next question comes from Rajesh Kumar of HSBC.

下一個問題來自匯豐銀行的 Rajesh Kumar。

I appreciate that you can't obviously give any color on Eliquis price negotiations. But when we look at your margin guidance this year, I'm assuming that you have made an assumption and that is implicit in that guidance an outcome of this negotiation? Or should we expect, as we get more clarity to adjust your guidance from what you learned?

我知道你顯然無法對 Eliquis 價格談判給出任何暗示。但是，當我們查看您今年的利潤率指引時，我假設您已經做出了假設，而該假設隱含在該指引中，是此次談判的結果？或者我們應該期待，隨著我們變得更加清晰，根據您所學到的知識來調整您的指導？

So Rajesh, thanks for the question. I'll try to start and then I'll turn it over to David to just talk a little bit about how we're thinking about margins, right? We're not going to be able to give any additional discussion around where we sit with IRA on Eliquis. We got the initial offer. We're going to follow the process they have and the price will be public in September, and we won't be providing additional details around that. But maybe David can talk to you a bit about how we think about margins generally.

所以 Rajesh，謝謝你的提問。我會嘗試開始，然後我會把它交給大衛，讓他稍微談談我們對利潤的看法，對嗎？我們無法就我們在 Eliquis 上與 IRA 的關係發表任何額外討論。我們收到了初步報價。我們將遵循他們的流程，價格將於 9 月公佈，我們不會提供更多相關細節。但也許大衛可以跟你談談我們對利潤的整體看法。

Just overall, as we guided, we anticipate gross margins to be about 74% this year, and that's really driven by the LOE brands coming down. But as the growth portfolio continues to increase, obviously, that will help offset longer term where those gross margins are going. We also said that our operating expenses grew in the mid low single-digit range. And with that, really, there's a lot going on there that as we said on Karuna, we're going to find savings and efficiencies in order to cover those expenses.

總體而言，正如我們所預期的，我們預計今年的毛利率將達到 74% 左右，這主要是由於 LOE 品牌的下滑。但隨著成長投資組合的不斷增加，顯然，這將有助於長期抵銷毛利率的下降。我們也表示，我們的營運費用成長率在中低個位數範圍內。事實上，正如我們在卡魯納會議上所說的那樣，有很多事情要做，我們將找到節約和提高效率的方法來支付這些費用。

But also, as Adam indicated, and I said in my opening remarks, we're increasing our investments in Camzyos and Sotyktu. So with that, we're finding from our legacy brands, re-funneling those resources into that. And all of that said, we'll be able to deliver a margin greater than 37% for the year, which we feel very confident about.

但正如亞當所指出的，我在開場白中也說過，我們正在增加對 Camzyos 和 Sotyktu 的投資。因此，我們從傳統品牌中尋找資源，重新投入其中。綜上所述，我們今年的利潤率將能夠達到 37% 以上，我們對此非常有信心。

Thanks, David. So I think that was it for the time that we have, but I thank you all for joining on the call today. I know it's a very busy day for all of you. Hopefully, you get a sense from the discussion this morning that we exited 2023 with good momentum to capitalize on the strategy that we have articulated about how we're going to navigate this decade. And of course, we look forward to sharing the progress against that on future calls.

謝謝，大衛。所以我想我們的時間就到此為止了，但我感謝大家今天的參加電話會議。我知道今天對你們所有人來說都是非常忙碌的一天。希望您從今天早上的討論中感受到，我們在 2023 年結束時勢頭良好，可以利用我們闡明的關於如何度過這個十年的戰略。當然，我們期待在未來的電話會議上分享進展。

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

至此，我們就結束通話了。像往常一樣，團隊隨時準備回答今天討論後的任何問題，我希望大家度過愉快的一天和愉快的周末。謝謝。

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

會議現已結束。感謝您參加今天的演示，現在您可以斷開連接了。