施貴寶 (BMY) 2021 Q1 法說會逐字稿

Good day, and welcome to the Bristol-Myers Squibb 2021 First Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead, sir.

美好的一天，歡迎參加百時美施貴寶 2021 年第一季度業績電話會議。今天的會議正在錄製中。現在，我想將會議交給投資者關係副總裁 Tim Power 先生。請繼續，先生。

Thanks, Keith, and good morning, everyone. Thanks for joining us today for our first quarter 2021 earnings call. Joining me this morning with prepared remarks are Giovanni Caforio, our Board Chair and Chief Executive Officer; and David Elkins, our Chief Financial Officer. Also participating in today's call for Q&A are Chris Boerner, our Chief Commercialization Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development.

謝謝基思，大家早上好。感謝您今天參加我們的 2021 年第一季度財報電話會議。今天早上與我一起發表準備好的講話的是我們的董事會主席兼首席執行官喬瓦尼·卡福里奧 (Giovanni Caforio)；和我們的首席財務官大衛埃爾金斯。參加今天的問答活動的還有我們的首席商業化官 Chris Boerner；以及我們的首席醫療官兼全球藥物開發主管 Samit Hirawat。

As you will see, we've posted slides to bms.com that you can use to follow along with for today's remarks. But before we get started, let me read our forward-looking statements.

正如您將看到的，我們已將幻燈片發佈到 bms.com，您可以使用這些幻燈片來跟隨今天的講話。但在我們開始之前，讓我先閱讀一下我們的前瞻性聲明。

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

在本次電話會議中，我們將就公司的未來計劃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存在重大差異。這些前瞻性陳述代表了我們截至目前的估計，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，我們特別不承擔任何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。這些非 GAAP 財務指標與最具可比性的 GAAP 指標的調節表可在 bms.com 上找到。喬瓦尼？

Thank you, Tim, and good morning, everyone. Let me start by saying that I'm proud of our continued strong execution during a global pandemic and the significant progress we are making against our strategy. I want to recognize and thank our global employees for their hard work and resilience through this challenging time.

謝謝蒂姆，大家早上好。首先我要說的是，我對我們在全球大流行期間持續強有力的執行力以及我們在戰略方面取得的重大進展感到自豪。我要表彰並感謝我們的全球員工在這個充滿挑戰的時期所做的辛勤工作和堅韌不拔的精神。

Now turning to Slide 4. We at the start of the year, I laid out our strategy to grow our business and renew our portfolio through the end of the decade. During the first quarter, we delivered strong results consistent with this strategy. We successfully grew our revenues, launched new medicines and new indications for I-O and continued to advance our pipeline.

現在轉向幻燈片 4。我們在年初制定了我們的戰略，以在本世紀末發展我們的業務並更新我們的產品組合。在第一季度，我們取得了符合這一戰略的強勁業績。我們成功增加了收入，推出了 I-O 新藥和新適應症，並繼續推進我們的產品線。

Starting with our financial performance, Our revenue grew 3% despite the impact of COVID-19-related buying patterns in Q1 of last year. Our quarter was strong for sales and EPS in the context of COVID-related dynamics for some of our products. Based on continued strength in our business, we are affirming our full year non-GAAP guidance for 2021. The accelerated renewal of our portfolio advanced across all 4 key therapeutic areas. Through regulatory approvals and clinical readouts, we're building a more diversified, younger portfolio that will fuel our growth through the decade and beyond.

從我們的財務業績開始，儘管去年第一季度受到與 COVID-19 相關的購買模式的影響，我們的收入仍增長了 3%。在我們某些產品與新冠病毒相關的動態背景下，我們這個季度的銷售和每股收益表現強勁。基於我們業務的持續實力，我們確認 2021 年全年非 GAAP 指引。我們的投資組合加速更新，在所有 4 個關鍵治療領域取得進展。通過監管部門的批准和臨床結果，我們正在建立一個更加多元化、更年輕的產品組合，這將推動我們在未來十年及以後的增長。

Although there remains uncertainty with how the COVID recovery will evolve, we are actively planning to return colleagues to the workplace, and are prioritizing plans to fully bring our sales reps back in the field, where conditions allow, to further support our in-line products and launches.

儘管新冠疫情的恢復仍存在不確定性，但我們正在積極計劃讓同事重返工作崗位，並優先考慮在條件允許的情況下將我們的銷售代表完全帶回現場，以進一步支持我們的內嵌產品並發射。

Let's turn to our execution scorecard on Slide 5. I am pleased that we've already made solid progress across the board during Q1. Specifically, in oncology, Opdivo is the first and only I-O agent with a first-line approval in gastric cancer. Combined with our opportunities in metastatic and adjuvant esophageal cancer, Opdivo can become the leading I-O medicine for patients with early and advanced GI cancers. We have strengthened the growth and long-term sustainability of our I-O franchise with a positive Phase III clinical trial for relatlimab. We're now the only company with 3 proven I-O mechanisms.

讓我們看一下幻燈片 5 上的執行記分卡。我很高興我們在第一季度已經全面取得了紮實的進展。具體來說，在腫瘤學領域，Opdivo 是第一個也是唯一一個獲得一線批准用於胃癌治療的 I-O 藥物。結合我們在轉移性和輔助性食管癌方面的機會，Opdivo 可以成為早期和晚期胃腸道癌症患者的領先 I-O 藥物。通過 relatlimab 的積極 III 期臨床試驗，我們加強了 I-O 特許經營權的增長和長期可持續性。我們現在是唯一一家擁有 3 種經過驗證的 I-O 機制的公司。

Building on our leadership position in melanoma with the Opdivo plus Yervoy regimen, we've now demonstrated a clinically meaningful PFS benefit on top of PD-1 monotherapy for a second I-O agent, which is a great accomplishment knowing the high efficacy of PD-1 monotherapy in first-line melanoma. This is great news for patients with advanced melanoma, and we look forward to presenting the data at ASCO in June.

憑藉 Opdivo 聯合 Yervoy 方案在黑色素瘤領域的領先地位，我們現在已經證明了在第二種 I-O 藥物的 PD-1 單藥治療之上具有臨床意義的 PFS 益處，這是一項偉大的成就，因為知道 PD-1 的高效能一線黑色素瘤的單一療法。這對於晚期黑色素瘤患者來說是個好消息，我們期待在 6 月份的 ASCO 上展示這些數據。

Beyond I-O, 6 of our 8 near-term launches are now successfully underway. In hematology, we made great progress in our cell therapy franchise with U.S. approvals of Breyanzi and Abecma. Our other new product launches are also progressing well.

除了 I-O 之外，我們近期的 8 項發布中的 6 項現已成功進行。在血液學領域，隨著 Breyanzi 和 Abecma 獲得美國批准，我們的細胞治療系列取得了巨大進展。我們的其他新產品發布也進展順利。

A lot is happening in immunology. We presented Phase III data for deucrava, which we expect to file later this year. We see this as an important medicine for patients and the company with significant revenue potential. As you know, deucrava is a first-in-class selective TYK2 inhibitor with the potential to become the new oral standard of care in moderate-to-severe psoriasis. It also has broader potential to treat diseases such as psoriatic arthritis, IBD and lupus.

免疫學領域正在發生很多事情。我們提供了 deucrava 的 III 期數據，預計將在今年晚些時候提交。我們認為這對於患者和公司來說是一種重要的藥物，具有巨大的收入潛力。如您所知，deucrava 是一種一流的選擇性 TYK2 抑製劑，有可能成為中重度銀屑病的新口服護理標準。它還具有治療銀屑病關節炎、炎症性腸病和狼瘡等疾病的更廣泛潛力。

In our mid-stage pipeline, we initiated the Phase III study for cendakimab in eosinophilic esophagitis. And in CV, we filed mavacamten with the FDA and have a PDUFA date of early next year.

在我們的中期管道中，我們啟動了 cendakimab 治療嗜酸性食管炎的 III 期研究。在 CV 中，我們向 FDA 提交了 mavacamten，並且 PDUFA 日期為明年初。

Given the potential for our early-stage pipeline with multiple assets across therapeutic areas and modalities, including protein homeostasis, cell therapy and next-generation biologics, we are planning a more in-depth session with you sometime in the fall to update you on the progress within our pipeline and how that further supports the long-term potential of the company.

鑑於我們的早期研發管線具有跨治療領域和模式的多種資產的潛力，包括蛋白質穩態、細胞療法和下一代生物製劑，我們計劃在秋季的某個時候與您舉行更深入的會議，向您介紹最新情況我們的管道內的進展以及如何進一步支持公司的長期潛力。

Now turning to Slide 6. Our team's execution as a new company so far has been remarkable and reinforces my confidence in our ability to capitalize on the potential for future growth. We remain focused on growing our business between 2020 and 2025. More importantly, we expect that in '25, our LOE products will constitute less than 10% of our business with roughly 1/3 of our continuing business coming from our launch portfolio. We believe our new launch portfolio has significant potential, with $20 billion to $25 billion of non-risk-adjusted sales potential in 2029. And this does not include the potential medicines that could come from our mid- or early-stage pipeline.

現在轉向幻燈片 6。作為一家新公司，我們團隊迄今為止的執行力非常出色，這增強了我對我們利用未來增長潛力的能力的信心。我們仍然專注於在 2020 年至 2025 年間發展我們的業務。更重要的是，我們預計到 25 年，我們的 LOE 產品將占我們業務的不到 10%，其中大約 1/3 的持續業務來自我們的推出產品組合。我們相信，我們新推出的產品組合具有巨大潛力，到 2029 年，非風險調整後的銷售潛力將達到 200 億至 250 億美元。這不包括我們中期或早期管道中可能出現的潛在藥物。

To close, I'm confident we have established a strong foundation for our future growth. The strength of our execution, promising launch opportunities ahead, the breadth of our pipeline and strength of our balance sheet positions us very well.

最後，我相信我們已經為未來的發展奠定了堅實的基礎。我們的執行力、未來有希望的推出機會、產品線的廣度和資產負債表的實力使我們處於非常有利的地位。

I will now turn it over to David to walk you through the financials. David?

現在我將把它交給大衛，讓他向您介紹財務狀況。大衛？

Thank you, Giovanni, and thank you all for joining our call today. I'd like to start with our strong top line performance on Slide 8. Our continued sales growth of 3% was driven by strong operational performance. When excluding the approximately $500 million of COVID-related buying patterns we experienced last year, underlying sales growth was strong, up 8%, or 6% excluding the benefits of foreign exchange, as our teams continue to execute very well while operating in a mostly virtual environment.

謝謝喬瓦尼，也感謝大家今天加入我們的電話會議。我想從幻燈片 8 中我們強勁的營收業績開始。我們 3% 的持續銷售額增長是由強勁的運營業績推動的。當排除我們去年經歷的約 5 億美元的新冠相關購買模式時，基本銷售增長強勁，增長了 8%，如果不考慮外彙的好處，則為 6%，因為我們的團隊在大多數情況下運營時仍然表現出色。虛擬環境。

I'll now provide additional color on the performance of our key brands and new launches, starting with Eliquis on Slide 9. This was another strong quarter for Eliquis as global sales were up 9% despite the unwinding of a fourth quarter inventory build and the approximately $350 million COVID-related build we experienced this time last year. In the U.S., first quarter sales increased 8% versus prior year, driven by strong demand with total prescriptions up 11% due to the strength of our position as the #1 NOAC. First quarter sales also included the impact of a onetime true-up of approximately $160 million related to the Medicare coverage gap.

現在，我將從幻燈片 9 上的 Eliquis 開始，對我們的主要品牌和新產品的表現提供更多信息。儘管第四季度的庫存增加和去年這個時候，我們經歷了大約 3.5 億美元的新冠肺炎相關建設。在美國，由於我們作為第一大 NOAC 的地位穩固，在強勁需求的推動下，第一季度銷售額比去年同期增長了 8%，總處方量增長了 11%。第一季度的銷售額還包括與醫療保險覆蓋缺口相關的約 1.6 億美元的一次性調整的影響。

As we look towards the second half of the year, we expect similar dynamics from the coverage gap as we've seen in prior years. We remain optimistic about the continued growth opportunity for Eliquis since we've seen both new-to-brand OAC volumes return to prepandemic levels as well as accelerated switching from warfarin.

當我們展望今年下半年時，我們預計覆蓋缺口將出現與前幾年類似的動態。我們對 Eliquis 的持續增長機會保持樂觀，因為我們看到新品牌 OAC 銷量恢復到大流行前的水平，並且加速從華法林轉向。

Internationally, sales remained strong, growing 11% versus prior year. Eliquis continues to be the #1 NOAC in multiple key markets internationally with significant room to grow. We remain very pleased with the execution of Eliquis around the world and expect to continue to grow Eliquis share within a growing class.

在國際市場，銷售額依然強勁，較上年增長 11%。 Eliquis 繼續成為國際多個主要市場中排名第一的 NOAC，具有巨大的增長空間。我們對 Eliquis 在全球的執行情況仍然非常滿意，並期望在不斷增長的階層中繼續增加 Eliquis 的份額。

Now turning to Opdivo on Slide 10. As it relates to the first quarter performance in the U.S., first-line lung shares remained in the low double digits within the I-O eligible population. The launch of our Opdivo plus Cabo indication in first-line renal is going well and further builds on our strong position in that space with significant uptake in the unfavorable segment where Opdivo plus Yervoy is not indicated. But we did see some impact from COVID during the quarter as the resurgence of the virus earlier in the year impacted offices at an infusion, we remain very confident in Opdivo's return to growth this year. Further supporting this growth, we are also very pleased with the recent approval of CheckMate -649 as Opdivo plus chemo is now the first I-O regimen approved in first-line gastric cancer. We look forward to launching additional indications in early-stage diseases across esophageal and muscle-invasive bladder cancers, which are expected to further contribute to our growth later this year.

現在轉向幻燈片 10 上的 Opdivo。由於它與美國第一季度的業績相關，因此 I-O 合格人群中一線肺部藥物的份額仍保持在較低的兩位數。我們在一線腎病中推出 Opdivo 加 Cabo 適應症進展順利，進一步鞏固了我們在該領域的強勢地位，在 Opdivo 加 Yervoy 未適應症的不利細分市場中獲得了顯著採用。但我們確實在本季度看到了新冠疫情的一些影響，因為今年早些時候病毒的捲土重來對辦公室造成了影響，我們對 Opdivo 今年恢復增長仍然非常有信心。為進一步支持這一增長，我們對 CheckMate -649 最近獲得批准也感到非常高興，因為 Opdivo 加化療現在是第一個批准用於一線胃癌的 I-O 方案。我們期待在食管癌和肌層浸潤性膀胱癌的早期疾病中推出更多適應症，預計這將進一步促進我們今年晚些時候的增長。

Additionally, we have multiple opportunities for future growth, including CheckMate -648, for the treatment in first-line esophageal cancer, which we announced as primary endpoints, as well as from other trials that will read out over time.

此外，我們還有多種未來增長機會，包括用於一線食管癌治療的 CheckMate -648（我們已宣布其為主要終點），以及隨著時間的推移將公佈的其他試驗。

Outside the U.S., sales were up 2% due to favorable effects of foreign exchange. We are encouraged to see strong adoption of new approvals and increased reimbursement, including the 9LA regimen in Europe and both 9LA and 227 regimens in Japan. These dynamics offset the second-line indications and the impact of COVID. Looking forward, we expect to expand the use of Opdivo in several additional indications currently under review. All in all, we remain very excited about the growth outlook for Opdivo.

在美國以外，由於外彙的有利影響，銷售額增長了 2%。我們很高興看到新的批准和增加的報銷得到大力採用，包括歐洲的 9LA 方案以及日本的 9LA 和 227 方案。這些動態抵消了二線適應症和新冠肺炎的影響。展望未來，我們預計將 Opdivo 的使用範圍擴大到目前正在審查的幾個其他適應症中。總而言之，我們對 Opdivo 的增長前景仍然感到非常興奮。

Moving to Slide 11, I'd like to touch on our in-line multiple myeloma portfolio. In the U.S., Revlimid sales are flat. Its growth was offset by the expected work-down of last quarter's inventory build. We also saw the expected seasonality that Revlimid and Pomalyst experienced due to patients entering the coverage gap early in the year.

轉到幻燈片 11，我想談談我們的內聯多發性骨髓瘤產品組合。在美國，來那度胺 (Revlimid) 的銷售額持平。其增長被上季度庫存增加的預期減少所抵消。我們還看到，由於患者在年初進入承保缺口，Revlimid 和 Pomalyst 經歷了預期的季節性。

Outside the U.S., we saw a 4% increase primarily from foreign exchange, as well as strong demand for triplet-based therapies, which offset the approximate $100 million combined impact of an inventory build in a tender last year. This resulted in a 1% increase for Revlimid globally. Global Pomalyst revenues were up 8%. This was driven by overall strong demand from triplet-based regimens and use in earlier lines.

在美國以外，我們看到 4% 的增長主要來自外匯，以及對三聯療法的強勁需求，這抵消了去年招標中庫存增加的約 1 億美元的綜合影響。這導致來那度胺 (Revlimid) 在全球範圍內的價格上漲了 1%。全球 Pomalyst 收入增長 8%。這是由基於三聯療法和早期產品線使用的整體強勁需求推動的。

Now we want to spend a few minutes sharing the progress we've made in the quarter on our recent launches on Slide 12. Our launches contributed $145 million in sales in the quarter. Let's start with Reblozyl, which generated $112 million in the first quarter. We continue to be pleased with the launch and uptake in new patient starts. We continue to see the transition from initial bolus to underlying demand. And while this market has seen some COVID impact, we remain focused on continuing to drive new starts for patients earlier in their treatment journey. Our initial launches in international markets are going well, and we will continue to add markets globally over the course of the year as we receive reimbursement.

現在，我們想花幾分鐘時間分享一下我們在本季度在幻燈片 12 上最近發布的產品中取得的進展。我們的產品發佈為本季度貢獻了 1.45 億美元的銷售額。讓我們從 Reblozyl 開始，該公司第一季度營收為 1.12 億美元。我們對新患者的啟動和吸收繼續感到滿意。我們繼續看到從最初的推注到潛在需求的轉變。儘管這個市場受到了新冠疫情的一些影響，但我們仍然專注於繼續為患者在治療旅程的早期推動新的開始。我們在國際市場的初步推出進展順利，在收到報銷後，我們將在今年繼續增加全球市場。

Moving to Zeposia, where we continue to see good traction in establishing the brand as the S1P modulator choice in multiple sclerosis. Positive initial prescribing experiences are translating into repeat scripts, and we are also encouraged to see patients convert to commercial supply at a quicker rate than before. Beyond multiple sclerosis, we look forward to launching Zeposia in ulcerative colitis with FDA approval expected at the end of May. Outside the U.S., we are pleased with Zeposia's MS launches in several markets, and we will continue to secure reimbursement in additional markets as the year progresses. The marketing authorization application for ulcerative colitis also remains under review in Europe with approval expected towards the end of this year.

轉向 Zeposia，我們繼續看到該品牌作為多發性硬化症 S1P 調節劑選擇的良好吸引力。積極的初始處方經驗正在轉化為重複處方，我們也鼓勵患者以比以前更快的速度轉向商業供應。除了多發性硬化症之外，我們還期待在潰瘍性結腸炎領域推出 Zeposia，預計 FDA 將於 5 月底獲得批准。在美國之外，我們對 Zeposia 的 MS 在多個市場的推出感到高興，隨著時間的推移，我們將繼續在其他市場獲得報銷。潰瘍性結腸炎的營銷授權申請也在歐洲仍在審查中，預計將於今年年底獲得批准。

Turning to Onureg. We continue to be encouraged by the launch where our teams remain focused on establishing the profile as the first and only oral treatment to demonstrate an overall survival benefit in the first-line maintenance setting of AML. Physician feedback and awareness have been positive, and our focus remains on shaping and establishing Onureg in a new maintenance segment of the AML treatment paradigm, which we know will take some time. Outside the U.S., we recently received a positive opinion from the CHMP with approval expected this year.

轉向奧努雷格。我們的團隊繼續致力於將其作為第一個也是唯一一個口服治療藥物的推出，以證明其在 AML 一線維持治療中的總體生存獲益，這讓我們繼續受到鼓舞。醫生的反饋和認識都是積極的，我們的重點仍然是在 AML 治療範式的新維持部分中塑造和建立 Onureg，我們知道這需要一些時間。在美國之外，我們最近收到了 CHMP 的積極意見，預計今年會獲得批准。

Turning to our new newly established cell therapy franchise on Slide 13. We are very excited to have launched 2 differentiated cell therapies for patients following the recent approval of Breyanzi in large B-cell lymphoma and Abecma in multiple myeloma.

轉向幻燈片 13 上我們新建立的細胞療法專營權。繼最近批准用於治療大 B 細胞淋巴瘤的 Breyanzi 和用於治療多發性骨髓瘤的 Abecma 後，我們非常高興能夠為患者推出 2 種差異化細胞療法。

First, regarding Breyanzi, our best-in-class CD19. While we are early in the launch, messages around efficacy and outpatient utilization are resonating, with high aided awareness among CAR-T treaters. We have also been very pleased with the rapid activation of our treatment sites as we now have approximately 55 sites activated with patients already apheresed and recently infused. And as it relates to Abecma, we're excited to have the first-ever BCMA CAR-T approved for patients with highly refractory multiple myeloma, where we're just a few weeks into the launch, we're encouraged by the enthusiasm we are hearing from customers for the treatment. We also see a real opportunity for synergy from the combined execution of these 2 therapies as Abecma is able to leverage the existing and growing site footprint of Breyanzi. For both these important new medicines, our priorities are expanding the site footprint through rapid account activation and maximizing our differentiated profiles while ensuring a seamless customer experience.

首先，關於 Breyanzi，我們一流的 CD19。雖然我們還處於啟動初期，但有關療效和門診利用率的信息引起了共鳴，CAR-T 治療人員的輔助意識很高。我們還對治療部位的快速激活感到非常滿意，因為我們現在大約有 55 個治療部位被激活，患者已經接受了血漿分離術並最近進行了輸注。與 Abecma 相關的是，我們很高興有史以來第一個 BCMA CAR-T 被批准用於高度難治性多發性骨髓瘤患者，我們推出僅幾週，我們對我們的熱情感到鼓舞。正在聽取客戶對治療的意見。我們還看到了這兩種療法的聯合執行帶來的真正的協同機會，因為 Abecma 能夠利用 Breyanzi 現有的和不斷增長的站點足跡。對於這兩種重要的新藥，我們的首要任務是通過快速帳戶激活來擴大網站足跡，並最大限度地提高我們的差異化形象，同時確保無縫的客戶體驗。

Now let me take you through a few items on the P&L on Slide 14. First, as we've said, our gross margin will continue to be largely a function of product mix, and in the first quarter, our gross margin rate was impacted by the strength of Eliquis, in addition to foreign exchange. Operating expenses reflect continued MS&A investment in our multiple launches across various therapeutic areas. And as that relates to our tax rate, our effective rate in the quarter was 16.8%, which reflects our earnings mix for the quarter.

現在讓我帶您了解幻燈片 14 上損益表的一些項目。首先，正如我們所說，我們的毛利率將繼續在很大程度上取決於產品組合，並且在第一季度，我們的毛利率受到了影響靠Eliquis的實力，除了外匯。運營費用反映了我們在各個治療領域的多次上市中持續進行的 MS&A 投資。由於這與我們的稅率有關，我們本季度的有效稅率為 16.8%，這反映了我們本季度的盈利組合。

Now switching gears to the balance sheet and our capital allocation on Slide 15. Our liquidity position remains strong with approximately $13 billion in cash and marketable securities, including strong cash flow from operations of nearly $4 billion in the quarter. Regarding capital allocation, business development remains our top priority for the company, and we will continue to evaluate opportunities to complement our internal innovation. With regard to our debt reduction this quarter, we've demonstrated our commitment to strong investment-grade credit rating by accelerating our repayment of debt by a $4 billion tender and redemption.

現在轉向幻燈片 15 上的資產負債表和資本配置。我們的流動性狀況依然強勁，擁有約 130 億美元的現金和有價證券，其中包括本季度近 40 億美元運營帶來的強勁現金流。在資本配置方面，業務發展仍然是公司的首要任務，我們將繼續評估補充內部創新的機會。關於本季度的債務削減，我們通過 40 億美元的投標和贖回加快了債務償還速度，展示了我們對強大投資級信用評級的承諾。

We are also committed to returning cash to shareholders through dividend and share repurchases. Recall that we increased our share repurchase authorization by $2 billion at the start of the year, and that we plan to buy back between $3 billion and $4 billion in shares this year. In the first quarter, we have already repurchased $1.8 billion toward that goal, and we will remain opportunistic as the year progresses.

我們還致力於通過股息和股票回購向股東返還現金。回想一下，我們在年初將股票回購授權增加了 20 億美元，併計劃今年回購 30 億至 40 億美元的股票。在第一季度，我們已經為實現這一目標回購了 18 億美元，隨著時間的推移，我們將保持機會主義。

Now turning to our 2021 guidance on Slide 16. Following this quarter's performance, we are reaffirming our non-GAAP guidance for the year, which reflects significant growth over last year. Our businesses have remained resilient, and our launch opportunities have come into fruition. Again, I'm pleased not with just the performance, but also with the considerable progress we made in executing our launches and advancing our pipeline.

現在轉向幻燈片 16 上的 2021 年指引。繼本季度的業績之後，我們重申了今年的非 GAAP 指引，這反映了較去年的顯著增長。我們的業務一直保持彈性，我們的推出機會已經取得成果。再說一次，我不僅對性能感到滿意，而且對我們在執行發布和推進管道方面取得的巨大進展感到滿意。

I'd now like to turn the call back over to Tim and Giovanni for Q&A.

我現在想將電話轉回蒂姆和喬瓦尼進行問答。

Great. Thanks very much, David. Keith, can we go to our first question, please?

偉大的。非常感謝，大衛。基思，我們可以回答第一個問題嗎？

We'll now take our first question from Terence Flynn of Goldman Sachs.

現在我們將回答高盛特倫斯·弗林提出的第一個問題。

It looks like the clinicaltrials.gov listing for your factor XIa Phase II study in total knee replacement is now showing a completion date of this month. So just wondering if we could actually get data from that trial here over the near term. And then looking back at enoxaparin's rate of bleeding in this setting, it looks to be about 4% to 5%. So just wondering what level of differentiation there you're looking for.

臨床試驗網站上列出的全膝關節置換術的 XIa 因子 II 期研究現在顯示完成日期為本月。所以只是想知道我們是否能在短期內真正從該試驗中獲得數據。然後回顧一下依諾肝素在這種情況下的出血率，看起來約為 4% 至 5%。所以只是想知道您正在尋找什麼程度的差異化。

Thank you, Terence. Samit, I'll pass the 2 questions on factor XI to you.

謝謝你，特倫斯。 Samit，我會將有關 XI 因子的 2 個問題轉給您。

Thank you, Terence. Looking forward to the readout of the first trial in the total knee replacement setting, which is testing the single-agent Factor XIa in the next couple of months as we look forward now. And also, as we've spoken before, the second trial will read out in the early part of next year as well. In totality, we'll be the one determining factor to really ascertain truly the overall safety, and of course, what we can gain in terms of efficacy to define the plan as we move forward. So more to come on that. I would not go into the specifics of what level of improvement we are trying to look for. Those are going to be defined with the differences that we see. But again, we've said before, if we can produce another agent for prevention of clotting and thrombosis at the level that is similar in efficacy but better safety profile, that is what we're looking for. And certainly looking forward to the data in combination with anti-platelet agents as well. Thank you.

謝謝你，特倫斯。期待全膝關節置換術中第一個試驗的結果，正如我們現在所期待的那樣，該試驗將在接下來的幾個月內測試單劑 XIa 因子。而且，正如我們之前所說，第二次審判也將於明年初宣讀。總而言之，我們將成為真正確定整體安全性的一個決定性因素，當然，我們也將在前進過程中確定計劃的有效性方面獲得什麼。所以還有更多的事情要做。我不會詳細說明我們正在尋求何種程度的改進。這些將根據我們看到的差異來定義。但我們之前說過，如果我們能夠生產另一種預防凝血和血栓形成的藥物，其功效相似但安全性更好，那就是我們正在尋找的。當然也期待與抗血小板藥物聯合使用的數據。謝謝。

We'll then take our next question. It comes from Chris Schott of JPMorgan.

然後我們將提出下一個問題。它來自摩根大通的克里斯·肖特。

Just 2 questions here. Maybe first, just maybe elaborate a little bit more in terms of LAG-3 and its role in the market. I guess, should we be thinking about this combo mostly as a kind of monotherapy competitor? Or is this something that you think from an efficacy standpoint, can stand up against an Opdivo-Yervoy type of combo?

這裡只有 2 個問題。也許首先，可能會詳細闡述一下 LAG-3 及其在市場中的作用。我想，我們是否應該主要將這種組合視為單一療法的競爭對手？或者您認為從功效的角度來看，這可以對抗 Opdivo-Yervoy 類型的組合嗎？

And then my second question was just a little bit more color on the Opdivo adjuvant launches. As we think about kind of treatment rates and development of these markets, just a little bit more color of how do we think about the esophageal and bladder kind of ramps as we think about kind of this year. So are these big 2021 events? Or is it just going to take a couple of years to really see the opportunity for those indications?

然後我的第二個問題是關於 Opdivo 佐劑發布的更多信息。當我們思考這些市場的治療率和發展時，我們如何看待今年的食管和膀胱類型的坡道。那麼這些是 2021 年的大事件嗎？或者是否需要幾年時間才能真正看到這些跡象的機會？

Thank you, Chris. So first, on LAG-3, let me share my enthusiasm for a fixed-dose combination, which represents a really important data to validate a third immuno-oncology agent from the company. And let me ask Chris to give you his perspective on dynamics in melanoma and where that fixed-dose combination may play and then give you insights into the uptake in adjuvant.

謝謝你，克里斯。首先，在 LAG-3 上，讓我分享一下我對固定劑量組合的熱情，這代表了驗證該公司第三種免疫腫瘤藥物的非常重要的數據。讓我請克里斯向您介紹他對黑色素瘤動態的看法以及固定劑量組合可能發揮的作用，然後讓您深入了解佐劑的吸收。

Yes. Thanks for the question, Chris. So let me start with LAG-3. So first, let me say that we are very excited and pleased with the data readout that we've seen for the third I-O that we have from BMS. The results are very encouraging. And I think seeing an enhanced activity on top of Opdivo in melanoma, that's a pretty high bar. And so we're excited about the opportunity to bring this to patients.

是的。謝謝你的提問，克里斯。讓我從 LAG-3 開始。首先，我要說的是，我們對從 BMS 看到的第三次 I-O 的數據讀數感到非常興奮和滿意。結果非常令人鼓舞。我認為 Opdivo 治療黑色素瘤的活性增強，這是一個相當高的標準。因此，我們很高興有機會將其帶給患者。

In terms of where it fits, you remember the current landscape of first-line melanoma, Opdivo-Yervoy represents about 35% to 40% of first-line melanoma. Approximately 30% of this market is still single-agent I-O, and you've got another 30% that is non-I-O. So we think there's a real clear opportunity here for us to drive the benefit of relatlimab plus OPDIVO into that population. There's clearly a continued unmet need with physicians looking for additional options that have a dual I-O-like effect, and we're looking forward to bringing that combination to patients as we work our way through the regulatory process.

就其適用範圍而言，您還記得目前一線黑色素瘤的情況，Opdivo-Yervoy 約佔一線黑色素瘤的 35% 至 40%。這個市場大約 30% 仍然是單代理 I-O，另外 30% 是非 I-O。因此，我們認為這裡有一個真正明顯的機會，可以讓 relatlimab 聯合 OPDIVO 為該人群帶來益處。顯然，醫生們一直在尋找具有雙重 I-O 效應的其他選擇，但這一需求仍未得到滿足，我們期待著在監管過程中將這種組合帶給患者。

In terms of the adjuvant opportunities, again, this is going to be an important opportunity as we get into the latter half of this year. And certainly, as we look about -- look for the growth opportunities beyond 2021, you noted esophageal and the upcoming opportunity with bladder. We're very excited about those. With adjuvant esophageal, this is a substantial patient population with considerable unmet need. The treatment rates here are relatively low today, just given the lack of approved therapy. So we would anticipate that over time, we'll be able to drive utilization, both in terms of the patients who are being treated today, which is relatively small, and then improve treatment rates over time, much the way we did, you'll recall, in adjuvant melanoma. And we would expect a similar dynamic to play out as we launch in bladder cancer as well. And so very excited about those opportunities and look forward to seeing those launches play out in the coming months.

就輔助機會而言，隨著我們進入今年下半年，這將是一個重要的機會。當然，當我們尋找 2021 年以後的增長機會時，您提到了食管和膀胱即將到來的機會。我們對此感到非常興奮。對於食管輔助治療來說，這是一個相當大的患者群體，其需求尚未得到滿足。由於缺乏批准的治療方法，目前這裡的治療率相對較低。因此，我們預計，隨著時間的推移，我們將能夠提高目前正在接受治療的患者的利用率（相對較小），然後隨著時間的推移提高治療率，就像我們所做的那樣，你’我記得，在輔助性黑色素瘤中。我們預計，當我們在膀胱癌領域推出時，也會出現類似的動態。對這些機會感到非常興奮，並期待在未來幾個月看到這些產品的推出。

Our next question comes from Seamus Fernandez of Guggenheim.

我們的下一個問題來自古根海姆的謝默斯·費爾南德斯。

So I wanted to follow up on Chris' question as it relates to LAG-3. I noticed at the -- as one of the ASCO abstracts, there's also an adjuvant trial that is supposed to really report some data. I assume that this is just a single-arm trial. But what's Bristol hoping for in adjuvant melanoma in particular, as well as the planned acceleration of the non-small cell lung cancer opportunity? Just hoping that Samit could maybe opine a little bit or give us a little bit of visibility on where he sees LAG-3 kind of potentially fitting in on the lung cancer side?

所以我想跟進 Chris 的問題，因為它與 LAG-3 相關。我注意到——作為 ASCO 摘要之一，還有一項輔助試驗應該真正報告一些數據。我認為這只是一個單臂試驗。但布里斯托爾對輔助黑色素瘤以及計劃加速非小細胞肺癌機會有何期望？只是希望 Samit 能發表一點意見，或者讓我們了解一下他認為 LAG-3 在肺癌方面的潛在作用嗎？

And then separately, just wanted to get a little bit of a better sense of your thoughts around the stroke -- the SPTS trial with factor XI. Still first half of next year? And maybe you could just remind us of the opportunity that you see there. In our view, we think that could be a $4 billion-plus opportunity that's really not reflected in expectations. But nobody knows this space better than Bristol-Myers Squibb, given your experience with products.

然後，我想更好地了解您對中風的想法——因子 XI 的 SPTS 試驗。還是明年上半年？也許您可以提醒我們您在那裡看到的機會。我們認為，這可能是一個價值超過 40 億美元的機會，但實際上並未反映在預期中。但考慮到您的產品經驗，沒有人比百時美施貴寶更了解這個領域。

Thank you. Thanks, Seamus, and thanks for the question. So let me just say before I pass it to Samit to answer both of your questions, that we really look forward to presenting the LAG-3 data at ASCO. I think it's going to be a great opportunity to show the strength of the data. And on factor XIa, let me just agree with you. This is a space we know extremely well, where we've demonstrated our ability to be successful with Plavix, of course, going back a few years, and with Eliquis, we're seeing as we speak now with the current performance of Eliquis. Samit?

謝謝。謝謝西莫，也謝謝你的提問。因此，在我將其交給 Samit 回答你們的兩個問題之前，我想說的是，我們非常期待在 ASCO 上展示 LAG-3 數據。我認為這將是展示數據力量的絕佳機會。關於因素 XIa，我同意你的觀點。這是一個我們非常熟悉的領域，當然，幾年前我們已經展示了我們通過 Plavix 取得成功的能力，而通過 Eliquis，我們現在看到了 Eliquis 目前的表現。薩米特？

Thank you, Giovanni. And certainly, very excited to see the data coming out, great for the patients and certainly very happy with where we're going in the pipeline for LAG-3 in oncology for BMS as well. Overall, the natural progression after seeing the data in the first-line setting of addition of relatlimab on top of Opdivo would be to go into the adjuvant setting. And that's where you're beginning to hear a lot more that we'll be progressing into a Phase III program in the adjuvant setting for this co-formulation that we now have as a fixed-dose combination for Opdivo plus relatlimab. Certainly more to follow as we look deeper into the data for the metastatic trial, to gain more in-depth knowledge on the biomarkers as well as the long-term follow-up that will come from the current 047 trial that will continue to evolve in terms of our knowledge.

謝謝你，喬瓦尼。當然，我們很高興看到數據的出現，這對患者來說非常好，當然也對我們在 BMS 腫瘤學領域的 LAG-3 研發過程中的進展感到非常滿意。總體而言，在看到在 Opdivo 之上添加 relatlimab 的一線設置中的數據後，自然的進展將是進入輔助設置。這就是您開始聽到更多消息的地方，我們將在這種聯合製劑的佐劑環境中進入 III 期計劃，我們現在將其作為 Opdivo 加 relatlimab 的固定劑量組合。當然，隨著我們更深入地研究轉移試驗的數據，以獲得有關生物標誌物的更深入的知識，以及來自當前 047 試驗的長期隨訪，該試驗將在就我們的知識而言。

Now the second part which you asked is about the non-small cell lung cancer opportunity. Certainly, excited to have started the early POC generation trial as well as looking at the combination of nivo plus relatlimab plus chemotherapy to see where we can take it. And that's the idea behind accelerating the enrollment in that trial so that by the end of the year, we can initiate a Phase III program in that setting if we have tolerability that is demonstrated in that early trial that we're looking at.

現在你問的第二部分是關於非小細胞肺癌的機會。當然，我們很高興能夠開始早期 POC 生成試驗，並研究 nivo 加 relatlimab 加化療的組合，看看我們可以將其應用於何處。這就是加速該試驗的註冊背後的想法，以便到今年年底，如果我們具有在我們正在研究的早期試驗中證明的耐受性，我們就可以在該環境中啟動第三階段計劃。

In addition to that, we will continue to hear evolution of the data potentially into hepatocellular carcinoma that we are looking also to have some look into in the Phase II study. And that can open up additional indications as we look forward.

除此之外，我們將繼續聽到可能轉化為肝細胞癌的數據的演變，我們也希望在 II 期研究中對此進行一些研究。正如我們所期待的，這可以提供更多的跡象。

Beyond that, in the SSP trial, yes, we are still looking forward to the readout in the early part of 2022. As I said earlier, there are 2 opportunities. Opportunity number one is to improve on the current anti-coagulation paradigm with a single agent. And then opportunity number two is to expand the use of anticoagulants with a background therapy of anti-platelet agents. And those are the 2 studies that together will form the basis of the clinical development plan that we are thinking through, whether it be the venous side or the arterial side of thrombosis.

除此之外，在 SSP 試驗中，是的，我們仍然期待 2022 年初的結果。正如我之前所說，有 2 個機會。第一個機會是用單一藥物改進當前的抗凝範例。第二個機會是擴大抗凝劑的使用，並以抗血小板藥物為背景治療。這兩項研究將共同構成我們正在考慮的臨床開發計劃的基礎，無論是血栓形成的靜脈側還是動脈側。

Our next question comes from Tim Anderson of 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。

I have a kind of a higher-level question on the PD-1 space. Can you just talk about your longer-term view on whether price competition in this category is kind of imminent or eventually will happen in developed markets, both U.S. and Europe? The space is clearly getting more crowded, both domestically produced PD-1s as well as those sourced from Chinese biopharma companies. And while price competition usually is not a winning strategy, it might be the only lever a lots of these other companies can pull, and I think at least in China as many have started to recognize the PD-1 category has become a commoditized class. So lots of folks are trying to figure out what precludes us from happening outside of China. Can you articulate your views here?

我有一個關於 PD-1 空間的更高級別的問題。您能否談談您對這一類別的價格競爭是否迫在眉睫或最終會在美國和歐洲等發達市場發生的長期看法？無論是國內生產的PD-1還是來自中國生物製藥公司的PD-1，這個領域顯然變得更加擁擠。雖然價格競爭通常不是製勝策略，但它可能是許多其他公司可以拉動的唯一槓桿，我認為至少在中國，因為許多人已經開始認識到 PD-1 類別已成為商品化類別。因此，很多人都在試圖弄清楚是什麼阻止了我們在中國以外的地區發生。您能在這裡發表一下您的看法嗎？

Thank you, Tim. Let me ask Chris to give you our perspective on a really important topic.

謝謝你，蒂姆。讓我請克里斯向您介紹我們對一個非常重要的話題的看法。

Yes. Thanks for the question, Tim. We obviously think about this quite a bit. As we think about the number of new PD-1 entrants in the market, we really look at it on 2 dimensions. First, there's the competitive impact of having additional players on the market. Frankly, that's an area that we pay attention to, but we're a little bit less concerned about. We have considerable resources focused on planning around competition. We have a good track record of competing in these markets. And while we're always a bit paranoid of potential new entrants, we feel very good about our ability to effectively manage competition.

是的。謝謝你的提問，蒂姆。我們顯然對此進行了很多思考。當我們考慮市場上新的 PD-1 進入者的數量時，我們實際上是從兩個維度來看待它的。首先，市場上有更多參與者會產生競爭影響。坦率地說，這是我們關注的一個領域，但我們不太關心。我們擁有大量資源專注於圍繞競爭進行規劃。我們在這些市場的競爭中擁有良好的記錄。雖然我們總是對潛在的新進入者有點偏執，但我們對自己有效管理競爭的能力感到非常滿意。

The second dimension that we look at is the one you're raising, which is the risk of commoditization of a market. And the way we look at that is commoditization, we think, requires 2 things. It requires a low-cost entrants and it requires perceived interchangeability on the part of payers, providers and patients. The risk of both of these things coming together likely varies, we believe, by geography, health care system. It may be even by therapeutic setting, but we pay very close attention to this. In terms of the risk, we absolutely believe it's something that we need to stay on top of. It's, as you note, very dynamic. Currently, the areas where we see the greatest risk don't overlap with our largest markets, at least today. But we certainly have plans to address the risk as they become more tangible.

我們關注的第二個維度是您提出的，即市場商品化的風險。我們認為，商品化需要兩件事。它需要低成本的進入者，並且需要付款人、提供者和患者方面具有可互換性。我們認為，這兩種情況結合在一起的風險可能因地理位置、醫療保健系統而異。甚至可能是通過治療環境來實現的，但我們對此非常關注。就風險而言，我們絕對相信這是我們需要掌控的事情。正如您所注意到的，它非常有活力。目前，我們認為風險最大的領域與我們最大的市場並不重疊，至少在今天是這樣。但隨著風險變得更加明顯，我們當然有計劃來解決這些風險。

The 2 things that I think we can continue to do that position us well against this threat are, first, continue to leverage the extremely broad data set that we have generated in I-O to ensure that treatment decisions continue to be clinically driven. And then second, continue to rapidly bring new data and approvals to market, such that we're constantly pushing forward innovation and changing the standard of care. But this is an area that's very dynamic, and we're paying close attention to it.

我認為我們可以繼續做兩件事，使我們能夠很好地應對這一威脅，首先，繼續利用我們在 I-O 中生成的極其廣泛的數據集，以確保治療決策繼續由臨床驅動。其次，繼續快速地將新數據和批准推向市場，以便我們不斷推動創新並改變護理標準。但這是一個非常活躍的領域，我們正在密切關注它。

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

我們的下一個問題來自美國銀行的傑夫·米查姆。

Just had a couple of quick ones. On your new launches, highlighted on Slide 12, what were some of the headwinds you saw for Reblozyl this quarter? I mean, what do you think could be the tipping point for Zeposia and Onureg for the current indications?

剛剛吃了幾個快速的。在幻燈片 12 中突出顯示的新產品發布中，您認為本季度 Reblozyl 面臨哪些不利因素？我的意思是，您認為就目前的適應症而言，Zeposia 和 Onureg 的轉折點是什麼？

And then the second question is with your cell therapy franchise. I know it's early, but just given the proximity of the 2 launches, are there synergies that you're seeing just with respect to site activation or reimbursement, et cetera?

第二個問題是您的細胞治療特許經營權。我知道現在還為時過早，但考慮到兩次發布的時間很接近，您是否在網站激活或報銷等方面看到了協同效應？

Thank you, Geoff. Chris, why don't you go ahead? Let me just give you my perspective. I'm really excited with what's happening on the front of our launch brands. The profile of the medicines that you mentioned is very differentiated. We have strong labels. And what we are hearing from physicians is exciting in terms of the potential role that these agents will have in the marketplace.

謝謝你，傑夫。克里斯，你為什麼不繼續呢？讓我給你我的觀點。我對我們推出的品牌所發生的事情感到非常興奮。你提到的藥物的特徵是非常不同的。我們有很強的標籤。就這些藥物在市場中的潛在作用而言，我們從醫生那裡聽到的消息令人興奮。

Let me just ask Chris to give you more insights into some of the launch dynamics you referenced, Geoff.

傑夫，我請克里斯為您提供有關您提到的一些發布動態的更多見解。

Sure. Thanks for the questions, Geoff. There's a lot there, so let me try to hit on each of these relatively quickly. So Reblozyl, we're very pleased actually with the continued strong execution of the teams, and what we're hearing on Reblozyl and our expectations for growth this year, and certainly in the long term, remain unchanged. As for the dynamics that we saw in the quarter, sales were relatively flat Q4 into Q1, and there were really 2 factors underlying this. First, as you will have heard from some of our peers, we have seen new patient volumes down in hematology generally. They were down about 10% to 20% versus pre-COVID levels in the MDS population and so that was one of the factors at play, at least for the quarter. And we have seen specific to Reblozyl, a bit of a prolonged bolus washout period.

當然。謝謝你的提問，傑夫。其中有很多內容，所以讓我嘗試相對快速地逐一介紹。因此，Reblozyl，我們實際上對團隊持續強勁的執行力感到非常滿意，我們對 Reblozyl 的了解以及我們對今年增長的預期，當然從長遠來看，也保持不變。至於我們在本季度看到的動態，第四季度到第一季度的銷售額相對持平，這實際上有兩個因素。首先，正如您從我們的一些同行那裡聽到的那樣，我們發現血液學領域的新患者數量普遍下降。 MDS 人群的數量與新冠疫情前的水平相比下降了約 10% 至 20%，因此這是起作用的因素之一，至少在本季度是這樣。我們還看到了 Reblozyl 特有的、較長的推注沖洗期。

And to give you some context around that, in Q4, we estimate that bolus patients for Reblozyl often were roughly around 40% of the overall business. In Q1, that has come down to about 20% to 25%, and we would expect those patients to continue to come off therapy over the coming months. Those 2 dynamics, notwithstanding, we are very encouraged by the continued uptake of new patient starts in this setting and continue to see new trials and an expansion of the prescriber base, which is critically important at this point in the launch. So continued excitement on our -- from our perspective with respect to Reblozyl.

為了給您提供一些相關背景信息，在第四季度，我們估計 Reblozyl 的推注患者通常約佔整體業務的 40% 左右。在第一季度，這一比例已下降至約 20% 至 25%，我們預計這些患者將在未來幾個月內繼續停止治療。儘管如此，我們對在這種情況下新患者的持續吸收感到非常鼓舞，並繼續看到新的試驗和處方者基礎的擴大，這在啟動的這一點上至關重要。從我們對 Reblozyl 的角度來看，我們持續感到興奮。

Onureg and Zeposia in terms of pivot points, I would say, as we have discussed in MS and as you've seen with some of our peers, it does take time to transition patients from written scripts to commercial dispensation in MS. That said, it was a big focus area as we discussed last year, and we are seeing very nice acceleration for Zeposia in MS. And of course, we have the opportunity in UC coming up with the PDUFA date in a month or so, and that's obviously another important opportunity for Zeposia and very much look forward to bringing this differentiated product and mechanism into IBD.

Onureg 和 Zeposia 就關鍵點而言，我想說，正如我們在 MS 中討論的那樣，正如您在我們的一些同行中看到的那樣，將患者從書面處方過渡到 MS 的商業配藥確實需要時間。也就是說，正如我們去年討論的那樣，這是一個重點領域，我們看到 Zeposia 在 MS 領域取得了非常好的加速。當然，我們有機會在 UC 中在一個月左右的時間內提出 PDUFA 日期，這顯然是 Zeposia 的另一個重要機會，並且非常期待將這種差異化的產品和機制引入 IBD。

Onureg, we're in the process of creating a market with Onureg, and that launch is going very well. In fact, we saw patient demand volume increase about 50% from Q4 coming into Q1. And I would say in that space, we're very excited with what we're seeing. Now again, it's a market where we're creating a new treatment paradigm, and that's going to take some time. But all indicators are that the efficacy profile of this data is landing well with customers. And again, the teams are executing well.

Onureg，我們正在與 Onureg 創建一個市場，並且啟動進展順利。事實上，我們看到患者需求量從第四季度到第一季度增加了約 50%。我想說，在這個領域，我們對所看到的感到非常興奮。現在，我們再次在這個市場上創造一種新的治療模式，這需要一些時間。但所有指標都表明，該數據的功效在客戶中表現良好。再說一次，團隊執行得很好。

And then pivoting to your question on cell therapy. We're very excited about the 2 cell therapy launches. Both products have been very well received. Given Breyanzi's got a little bit more data in terms of the launch timing, let me start there. The launch there is going very well. We've had over 50 accounts that have been activated already. Our highest priority accounts, in fact, were activated within 8 weeks of approval. The messaging around the best-in-class profile for Breyanzi is landing well. Physicians are clearly seeing a differentiated safety profile. And in fact, we've already infused -- apheresed and infused patients with Breyanzi and so I would say the execution there has been exceptionally well.

然後轉向你關於細胞療法的問題。我們對 2 細胞療法的推出感到非常興奮。這兩款產品都非常受歡迎。鑑於 Breyanzi 在發射時間方面獲得了更多數據，讓我從這裡開始。那裡的發射進展順利。我們已經有超過 50 個帳戶被激活。事實上，我們的最高優先級帳戶在批准後 8 週內就被激活了。關於 Breyanzi 一流的形象的信息正在順利傳播。醫生們清楚地看到了差異化的安全狀況。事實上，我們已經為患者輸注了 Breyanzi，所以我想說那裡的執行情況非常好。

And just quickly on Abecma. Obviously, a bit earlier in the process for Abecma, but we have the advantage of launching that product on top of the infrastructure that we've built with Breyanzi. So we've actually been able to more rapidly activate sites there. We've had 25 centers were activated within 10 days of approval. The physician feedback has been very positive, and there's a lot of enthusiasm for us bringing the first BCMA-targeted cell therapy into multiple myeloma. So, so far, early days, but the launches seem to be off to a very good start.

很快就可以使用 Abecma。顯然，Abecma 的流程有點早，但我們的優勢是在我們與 Breyanzi 構建的基礎設施之上推出該產品。所以我們實際上能夠更快地激活那裡的站點。我們已經有 25 個中心在批准後 10 天內啟動。醫生的反饋非常積極，人們對我們將第一個 BCMA 靶向細胞療法引入多發性骨髓瘤充滿熱情。到目前為止，還處於早期階段，但發布似乎有了一個非常好的開始。

Our next question comes from Andrew Baum of Citi.

我們的下一個問題來自花旗銀行的安德魯·鮑姆。

First question is to Giovanni. In relation to business development, Bristol, we anticipate it's going to be more active than many of your peers given the cadence of LOEs you have in your portfolio. The FTC has been making increasingly loud noises about consolidation being a driver of increased drug prices and diminish patient access of late. I'm interested on how you think this could impact our business development going forward, whether it's more noise than actions, and what we should be looking for in novel mechanisms to engage to determine whether M&A relates in anticompetitive activities.

第一個問題是問喬瓦尼的。在業務發展方面，布里斯托爾，考慮到您投資組合中 LOE 的節奏，我們預計它將比您的許多同行更加活躍。聯邦貿易委員會一直在不斷大聲疾呼，稱整合是藥品價格上漲和最近患者獲取藥品減少的驅動因素。我感興趣的是，您認為這會如何影響我們未來的業務發展，這是否是噪音多於行動，以及我們應該在新機制中尋找什麼來確定併購是否與反競爭活動有關。

And then second question for Samit. Perhaps you care to comment on whether you anticipate a panel meeting to assess JAK safety broadly in a cross-divisional way. I'm obviously thinking about deucravacitinib in terms of its broader membership of that particular category.

然後是薩米特的第二個問題。也許您願意評論是否預計召開小組會議以跨部門的方式廣泛評估 JAK 安全性。顯然，我正在考慮 deucravacitinib 的特定類別更廣泛的成員資格。

Thank you, Andrew. Let me start with your question on business development, and then Samit will follow on your second question. So it's really difficult to speculate at this point in early days what the evolving position of the FTC will be. A couple of things that I would say is, number one, I do agree with you that business development is an important priority for us. It has been for a while. And it will remain one of the priorities for deploying capital in our capital allocation strategy.

謝謝你，安德魯。我先回答你關於業務發展的問題，然後薩米特回答你的第二個問題。因此，在早期階段，很難推測聯邦貿易委員會的立場將如何演變。我想說的幾件事是，第一，我確實同意您的觀點，即業務發展是我們的重要優先事項。已經有一段時間了。這仍將是我們資本配置策略中資本配置的優先事項之一。

The second thing that I like to say is that I actually feel that we've demonstrated over and over that when we acquire assets into the company, it's actually a way of accelerating their development and generating even more value for patients. And that's an important element of what drives our business development strategy. I feel there are plenty of opportunities to continue to strengthen our portfolio across all of the areas where we have presence and expertise. And obviously, we'll always take competition issues into account when we look at opportunities, but I don't see that at this point as limiting our ability to continue to execute a very differentiated business development strategy. So with that, Samit?

我想說的第二件事是，我實際上覺得我們已經一再證明，當我們收購公司資產時，這實際上是加速其發展並為患者創造更多價值的一種方式。這是推動我們業務發展戰略的重要因素。我認為在我們擁有業務和專業知識的所有領域都有很多機會繼續加強我們的投資組合。顯然，當我們尋找機會時，我們總是會考慮競爭問題，但我認為目前這並不會限制我們繼續執行非常差異化的業務發展戰略的能力。那麼，薩米特？

Yes. Thanks, Andrew. And certainly, yes, we've heard the speculation around AdCom for potentially looking at it from a safety perspective for TYK2 inhibitors and whether they belong in the JAK. The way we think about it is as we have presented, if you look at the data, we do believe it is very differentiated. And there are absolutely good measures in terms of thinking around preclinical data, the clinical data, the mechanism of action and the way the data has evolved also on the efficacy side. So overall, I think we have very strong arguments. If there is an AdCom, certainly, we'll be prepared with that with all the data that we've shared already, and we'll continue to evolve in terms of a long-term follow-up as well. We do believe this is new breakthrough in science.

是的。謝謝，安德魯。當然，是的，我們已經聽到了圍繞 AdCom 的猜測，他們可能會從 TYK2 抑製劑的安全角度來看待它，以及它們是否屬於 JAK。我們的思考方式正如我們所展示的那樣，如果你看一下數據，我們確實相信它是非常差異化的。在圍繞臨床前數據、臨床數據、作用機制以及數據演變方式的思考方面，在功效方面也有絕對好的措施。總的來說，我認為我們有非常有力的論據。當然，如果有 AdCom，我們將利用我們已經共享的所有數據做好準備，並且我們也將在長期後續行動方面繼續發展。我們確實相信這是科學的新突破。

It's a new first-in-class molecule for a -- as a TYK2 inhibitor, potentially first as it brings new efficacy data for patients with psoriasis, which is an unmet medical need. So certainly looking forward to sharing more as we go along. At the current time, we are in discussions in terms of preparing the file and getting it to the regulators and move it forward as soon as possible.

作為 TYK2 抑製劑，它是一種新的一流分子，可能是第一個，因為它為銀屑病患者帶來了新的療效數據，這是一種未滿足的醫療需求。所以當然期待在我們前進的過程中分享更多。目前，我們正在討論準備文件並將其提交給監管機構並儘快推進。

Our next question comes from Ronny Gal of Bernstein.

我們的下一個問題來自伯恩斯坦的羅尼·加爾。

Two, if I may. First, the office has now come out to restructure Part D with some participation by pharma through the cost structure of roughly 10%, even from a Democratic side -- from the Republican side. I was wondering if you could just kind of ballpark for us the relative impact of pharma participation in the cost structure of Part D and how does that translates into your own revenue.

如果可以的話，兩個。首先，該辦公室現在已經開始重組 D 部分，製藥公司也參與其中，成本結構約為 10%，甚至來自民主黨一方——來自共和黨一方。我想知道您是否可以為我們大致了解一下製藥公司參與 D 部分成本結構的相對影響，以及這如何轉化為您自己的收入。

And second, I was wondering how you're going to handle the difference in prices for Zeposia between the MS market and the IBD market because of the 2 different price stance and you're transcending that. So how are you thinking about handles?

其次，我想知道你們將如何處理 MS 市場和 IBD 市場之間 Zeposia 的價格差異，因為兩種不同的價格立場，而你們正在超越這一點。那麼你如何看待手柄呢？

Ronny, it's Tim. We couldn't quite hear the first part of your question. We heard the part about the price on Zeposia. Could you repeat the beginning of your question, if you don't mind?

羅尼，是蒂姆。我們聽不太清你問題的第一部分。我們聽到了關於 Zeposia 價格的部分。如果您不介意的話，可以重複一下問題的開頭嗎？

Sure. Part D restructuring, can you give us a feel for how kind of like a 10% get reimbursement requirements by pharma translate into invest in your revenue?

當然。 D 部分重組，您能否讓我們了解一下製藥公司 10% 的報銷要求如何轉化為您的收入投資？

Okay. Thank you. Thanks very much. Let me start there, and then I'll ask Chris to address your question on Zeposia. So let me say, obviously, there is continued dialogue about the potential benefit design changes that may be discussed by the administration. And I think it's premature to go into any assessment of what the Part D redesign may -- what elements may be discussed going forward. I think what's important is a couple of things. So first of all, as you know, we have a very diversified portfolio across multiple payer segments and multiple therapeutic areas. And so there will always be different impacts on different parts of our portfolio from any benefit redesign and very different dynamics for a product like Revlimid versus a product like Eliquis. So that makes it difficult to give you any insights into the impact of reforms because it really is important to know the details.

好的。謝謝。非常感謝。讓我從這裡開始，然後我將請 Chris 回答您關於 Zeposia 的問題。因此，我要說的是，顯然，政府可能會討論潛在的福利設計變更的對話。我認為現在對 D 部分可能重新設計的內容進行評估還為時過早 - 未來可能會討論哪些內容。我認為重要的是幾件事。首先，如您所知，我們在多個付款細分市場和多個治療領域擁有非常多元化的投資組合。因此，Revlimid 等產品與 Eliquis 等產品的任何利益重新設計和非常不同的動態都會對我們產品組合的不同部分產生不同的影響。因此，這使得你很難深入了解改革的影響，因為了解細節確實很重要。

What I think it's more important is the fact that from our perspective, it is critical that we look at reforms and have one objective in mind, which is to improve affordability for patients in Medicare Part D. That's sort of the core of the priority that the industry has. And the proposals that we'll continue to make as we interact with the administration, we'll be focused on elements of Part D redesign that include establishing out-of-pocket caps, reducing the overall impact to patients in the catastrophic phase, smoothing expenses throughout the year. And so as proposals progress, I think it will be easier for us to provide insights into how that impacts our portfolio. Chris?

我認為更重要的是，從我們的角度來看，至關重要的是我們要考慮改革並牢記一個目標，即提高醫療保險 D 部分患者的負擔能力。這是優先事項的核心該行業有。在與政府部門互動時，我們將繼續提出建議，我們將重點關注 D 部分重新設計的要素，包括建立自付費用上限、減少災難階段對患者的總體影響、平滑全年開支。因此，隨著提案的進展，我認為我們將更容易提供有關這如何影響我們的投資組合的見解。克里斯？

Yes. Thanks for the question. Obviously, we are keenly aware of the differential in prices between the MS market and UC. As you know, we priced Zeposia in line with the value it provides and ensuring the broadest patient access in the MS market. And as we think about UC, it's certainly too early at this point to discuss how we're thinking about pricing in UC. What I would say is that we're going to factor price considerations. How we think about the broader access and the importance of access in IBD generally. And we have plans in place that we'll execute as we get closer to the approval of Zeposia in UC, but it's something we've been focused on for some time.

是的。謝謝你的提問。顯然，我們敏銳地意識到MS市場和UC市場之間的價格差異。如您所知，我們根據 Zeposia 提供的價值對其進行定價，並確保 MS 市場上最廣泛的患者使用。當我們考慮 UC 時，現在討論我們如何考慮 UC 定價肯定還為時過早。我想說的是，我們將考慮價格因素。我們如何看待 IBD 中更廣泛的准入以及准入的重要性。我們已經制定了計劃，當 Zeposia 在 UC 獲得批准時我們將執行這些計劃，但這是我們一段時間以來一直關注的事情。

Our next question comes from David Risinger of Morgan Stanley.

我們的下一個問題來自摩根士丹利的大衛·瑞辛格。

Yes. I have 2 questions, please. First, could you just discuss the bar that Bristol-Myers set in first-line melanoma with the combination of Opdivo plus Yervoy? Just so we have that in context ahead of the LAG's readout ahead.

是的。我有 2 個問題，請問。首先，您能否討論一下百時美施貴寶公司通過 Opdivo 和 Yervoy 聯合治療一線黑色素瘤所設定的標準？正是這樣，我們在 LAG 宣讀之前就已經了解了這一點。

And then second, could you provide a framework for Zeposia sales drivers in coming years in both the U.S. and ex U.S.?

其次，您能否為未來幾年在美國和美國以外地區的 Zeposia 銷售驅動因素提供一個框架？

Thank you, David. Let me ask Samit to start and give you his perspective on first-line melanoma, and then Chris can add any perspective there and give you an answer on Zeposia.

謝謝你，大衛。讓我請 Samit 首先向您介紹他對一線黑色素瘤的看法，然後 Chris 可以添加任何觀點並為您提供有關 Zeposia 的答案。

Yes. Thanks for the question, David. The way to look at it, though, as Chris mentioned earlier, there's still a large number of patients who are treated with either single agent I-O or through non-I-O regimens. So yes, O plus Y is a very important regimen, has shown very important efficacy and long-term effects and maintenance of that effect and so therefore, it becomes important. What we are now bringing is an additional, let's say, treatment potential for patients who can be treated, who have melanoma in the first-line setting with relatlimab on top of nivolumab as a single agent.

是的。謝謝你的提問，大衛。不過，正如 Chris 之前提到的，仍有大量患者接受單藥 I-O 或非 I-O 方案治療。所以是的，O加Y是一個非常重要的治療方案，已經顯示出非常重要的功效和長期效果以及該效果的維持，因此它變得很重要。我們現在為那些可以接受治療的黑色素瘤患者帶來了額外的治療潛力，這些患者在一線治療中使用 relatlimab 和 nivolumab 作為單一藥物。

And that's the reason why we're excited about this, to be able to add to the treatment paradigm for prescribers and for patients to potentially use in the future once approved in this particular setting. One has to remember that we are also talking about the safety profile and its differentiation over here. So relatlimab plus nivolumab, therefore, becomes an important aspect of the treatment paradigm looking at the future.

這就是我們對此感到興奮的原因，一旦在這種特定環境下獲得批准，能夠為處方者和患者添加治療範例，以便將來可能使用。必須記住，我們在這裡還討論了安全性及其差異化。因此，relatlimab 加納武單抗成為未來治療範式的一個重要方面。

Yes. And then let me take the question on Zeposia, David. So the way we think about Zeposia is, first of all, we're very excited about the opportunity initially that we have both in the U.S. and ex U.S. in MS. We think that Zeposia brings a very differentiated profile into this market. It's now in the U.S., the #1 SP in terms of written prescriptions. We're gaining on oral agents. And as I mentioned earlier, we are making progress in terms of optimizing the patient pull-through in terms of commercial dispense. So we think we've got considerable opportunity to continue to grow in the short term in MS in the U.S. Ex U.S., it's still very early days for the launches of Zeposia, but I would say that in the early launch markets in Europe, Zeposia's uptake appears to be very good, particularly in markets like Germany.

是的。然後讓我回答關於 Zeposia 的問題，大衛。因此，我們對 Zeposia 的看法是，首先，我們對最初在美國和美國以外的 MS 領域擁有的機會感到非常興奮。我們認為 Zeposia 為這個市場帶來了非常差異化的形象。它現在在美國是書面處方方面排名第一的 SP。我們正在取得口服藥物的進展。正如我之前提到的，我們在優化商業配藥方面的患者拉通方面正在取得進展。因此，我們認為我們在美國的 MS 市場短期內有相當大的機會繼續增長。除美國外，Zeposia 的推出還處於早期階段，但我想說，在歐洲的早期推出市場，Zeposia 的吸收率似乎非常好，特別是在德國等市場。

So I think in the near term, there's going to be clearly a focus on maximizing the opportunity that we have with Zeposia in that market globally. And then, of course, with the upcoming launch in UC, that becomes a much more important opportunity for us as we get into 2022 and beyond. Zeposia's profile looks very good. The feedback we've gotten from treaters in the IBD space is very positive. Obviously, the rate limiter in terms of the U.S. uptake is going to be accessed. We know that's a very important component, and we're going to approach that in a very stepwise fashion. It's going to be important that we drive volume initially in those patients -- with those patients who have insurance that is open or relatively unrestricted. And then we'll leverage the Zeposia profile to drive additional utilization and then, of course, work with payers to ensure that we continue to increase the access that patients have in that space. That will clearly take some time. But we think the opportunity in IBD for Zeposia is substantial, and that will be important both in the U.S. and ex U.S. as we get into that launch in -- later in 2021 and then certainly 2022 and beyond.

因此，我認為短期內，我們的重點顯然是最大限度地利用 Zeposia 在全球市場上的機會。當然，隨著 UC 即將推出，隨著我們進入 2022 年及以後，這對我們來說將成為一個更加重要的機會。 Zeposia的個人資料看起來很不錯。我們從 IBD 領域的治療師那裡得到的反饋非常積極。顯然，美國的吸收率將受到限制。我們知道這是一個非常重要的組成部分，我們將以逐步的方式實現這一點。重要的是，我們首先要增加這些患者的治療量——那些擁有開放或相對不受限制的保險的患者。然後，我們將利用 Zeposia 配置文件來提高利用率，當然，我們還會與付款人合作，以確保我們繼續增加患者在該空間的訪問權限。這顯然需要一些時間。但我們認為 Zeposia 在 IBD 領域的機會是巨大的，當我們在 2021 年晚些時候、當然是 2022 年及以後推出該產品時，這對於美國和美國以外的國家都非常重要。

Our next question comes from Greg Gilbert of Truist Securities.

我們的下一個問題來自 Truist 證券公司的格雷格·吉爾伯特。

On LAG-3, how are you thinking about the importance of biomarkers here? And what level of granularity should we expect around the data set of ASCO as it relates to LAG-3 positivity, et cetera?

在 LAG-3 中，您如何看待生物標誌物的重要性？當 ASCO 數據集與 LAG-3 陽性等相關時，我們應該期望什麼級別的粒度？

And then Giovanni, a different twist perhaps on the business question. When you took over a CEO, I imagine there was quite a sense of urgency to diversify the company. But with the steps you've already taken to do so, would it be fair to characterize your M&A strategy from here as more about enhancing existing franchises and less about diversification as a concept?

然後是喬瓦尼，也許在商業問題上有不同的轉變。當你接任首席執行官時，我想你有一種使公司多元化的緊迫感。但是，根據您已經採取的步驟，從這裡開始將您的併購戰略描述為更多地關注增強現有特許經營權而不是多元化作為一個概念是否公平？

Thank you, Greg. Let me start there, and then I'll ask Samit to give you an answer on the biomarker strategy for LAG-3. I think you're absolutely right. I believe that one of the things that is a clear strength for the company today is the diversification of our business. When you look at our oncology business, solid tumors and hematology, what's happening in immunology, which is clearly the fastest-growing segment of our business right now and the long-term sustainable leadership position that we have in cardiovascular medicine, I think that we have an incredibly well-diversified set of businesses with strong dynamics for all 4 of them. So I think that's an important foundation that we've built for the company.

謝謝你，格雷格。讓我從這裡開始，然後我將請 Samit 為您提供有關 LAG-3 生物標誌物策略的答案。我認為你是完全正確的。我相信，當今公司的明顯優勢之一就是我們業務的多元化。當你看看我們的腫瘤學業務、實體瘤和血液學、免疫學領域正在發生的事情時，這顯然是我們目前增長最快的業務領域，也是我們在心血管醫學領域長期可持續的領導地位，我認為我們擁有令人難以置信的多元化業務，這四項業務都具有強勁的活力。所以我認為這是我們為公司建立的重要基礎。

And at this point, I see that as an opportunity because we have capabilities that we can leverage. We clearly have deep expertise, whether that's from a scientific and development perspective or from a commercial perspective, growing in all of those areas. And it gives us an opportunity to look at assets where we can acquire really promising technology, apply our expertise and maximize the value of those assets. So the priority for us now in business development is across all of those areas, to continue to strengthen our portfolio. And as I've mentioned several times, the objective that we have is to further strengthen the outlook in the second part of the decade. But our business is extremely well diversified at this point. Samit?

在這一點上，我認為這是一個機會，因為我們擁有可以利用的能力。無論是從科學和發展的角度還是從商業的角度來看，我們顯然都擁有深厚的專業知識，並且在所有這些領域都在不斷發展。它使我們有機會尋找資產，在這些資產中我們可以獲得真正有前途的技術，應用我們的專業知識並最大限度地提高這些資產的價值。因此，我們現在業務發展的首要任務是在所有這些領域，繼續加強我們的產品組合。正如我多次提到的，我們的目標是進一步加強本十年後半段的前景。但目前我們的業務非常多元化。薩米特？

Thanks, Greg. Thanks, Giovanni, and thanks, Greg, for the question as well. For LAG-3, obviously, I'll not get into the specifics of the data that we presented at ASCO. But certainly, some of the biomarker data will be included in the presentation. As you may recall from all the published literature around LAG-3 and in general, for I-Os, it's been a difficult exercise to get specificities around which biomarkers really dictate the activity of the medicines that we are testing and exploring. So we'll continue to get into that, into deeper details after the data are presented, but certainly looking forward to a better understanding of the overall landscape and as we look to the combinations and other indications as well.

謝謝，格雷格。謝謝喬瓦尼，也謝謝格雷格提出的問題。顯然，對於 LAG-3，我不會詳細介紹我們在 ASCO 上提供的數據。但當然，一些生物標誌物數據將包含在演示文稿中。您可能還記得有關 LAG-3 的所有已發表文獻以及一般而言，對於 I-O，要明確哪些生物標誌物真正決定了我們正在測試和探索的藥物的活性，這是一項困難的工作。因此，在提供數據後，我們將繼續深入研究這一問題，更深入的細節，但當然期待更好地了解整體情況，並在我們研究組合和其他跡象時。

Our next question comes from Matt Phillips (sic) [Phipps] of William Blair.

我們的下一個問題來自威廉·布萊爾的馬特·菲利普斯（原文如此）[Phipps]。

Just 2 quick ones. Can you give us any update on time lines for an EFS look and the CheckMate -816 trial? And how do you think the overall market there and the potential opportunity there is impacted by the Roche and [Power] ONO positive announcement.

就2個快的。您能給我們提供有關 EFS 外觀和 CheckMate -816 試用的時間線的任何更新嗎？您認為羅氏和 [Power] ONO 的積極聲明對那裡的整體市場和潛在機會有何影響。

And then secondly, on the TYK2 given the strong results you saw in moderate-to-severe patients and then also the attempted advanced study in mild to moderate. Any plans to maybe run an additional head-to-head study versus Otezla in a mild-to-moderate patient population to expand the opportunity?

其次，在 TYK2 上，您在中度至重度患者中看到了強勁的結果，並且在輕度至中度患者中嘗試進行了高級研究。是否有計劃在輕度至中度患者群體中進行與 Otezla 進行額外的頭對頭研究以擴大機會？

Thank you, Matt. Let me ask Samit to address both of your points.

謝謝你，馬特。讓我請薩米特回答你的這兩點。

Well, the second one, probably I'll pass it on to Chris. So first one, I will say that for EFS for 816, you've seen the data already for the pathologic complete response is certainly very, very encouraging. Looking forward to the EFS readout towards the end of 2022, early 2023 time frame. So it still remains, from that perspective, on track, and we'll certainly be sharing it as soon as we have that data available.

好吧，第二個，我可能會把它轉給克里斯。首先，我要說的是，對於 816 的 EFS，您已經看到病理完全緩解的數據肯定非常非常令人鼓舞。期待 2022 年底、2023 年初的 EFS 數據公佈。因此，從這個角度來看，它仍然處於正軌，一旦我們獲得這些數據，我們肯定會立即分享它。

Just one more thing that I want to clarify what I said early on, on Andrew's question around the speculation around the AdCom. The speculation that we hear is around the JAK inhibitors, and we have no knowledge around inclusion of TYK2 as being included in there. And that's why I just want to clarify one more time.

我還想澄清我之前所說的一件事，即安德魯關於 AdCom 猜測的問題。我們聽到的猜測是關於 JAK 抑製劑的，我們不知道其中是否包含 TYK2。這就是為什麼我想再澄清一次。

And let me just very quickly hit on the commercial opportunity for 816 and then turn it back to Samit on TYK. We're happy with the results, obviously, that we've seen so far with 816. As Samit just mentioned, the data continue to emerge in this space. What I would say is that this is a fairly sizable opportunity. There are about just shy of 30,000 treatable patients here. The treatment rates are in the order of 60% to 65%. So we think there's an opportunity to do 2 things. One, obviously, provide an opportunity in the neoadjuvant space for those patients who are being treated today and potentially continue to push the treatment rate. And remember, many patients will be identified once you have more active treatments that are available in this space. So we think there's considerable opportunity here. Samit?

讓我很快發現 816 的商業機會，然後將其轉回給 TYK 上的 Samit。顯然，我們對迄今為止在 816 上看到的結果感到滿意。正如 Samit 剛才提到的，該領域的數據不斷湧現。我想說的是，這是一個相當大的機會。這里大約有不到 30,000 名可治療的患者。治療率約為60%至65%。所以我們認為有機會做兩件事。顯然，其中之一為目前正在接受治療的患者提供了新輔助治療的機會，並有可能繼續提高治療率。請記住，一旦您在該領域擁有更積極的治療方法，許多患者就會被識別出來。所以我們認為這裡有相當大的機會。薩米特？

Great. Thank you. And in terms of the TYK2 versus Otezla product, I think, first of all, we are excited about the data that we have. We have, obviously, the mechanism of action that is quite unique over here. We've seen the data in the moderate-to-severe psoriasis. We have additional studies that are ongoing in the IBD space, in the lupus space. The discussion around moderate to severe -- mild-to-moderate psoriasis continues, and we'll certainly share with you ultimately what the plans would be. But truly excited today where we are, and certainly, the evolution of the data at the end of the year in additional indications. We are not ready to share yet our plans for mild-to-moderate psoriasis.

偉大的。謝謝。就 TYK2 與 Otezla 產品而言，我認為，首先，我們對現有的數據感到興奮。顯然，我們的作用機制在這裡非常獨特。我們已經看到了中度至重度牛皮癬的數據。我們正在 IBD 領域、狼瘡領域開展其他研究。關於中度至重度——輕度至中度牛皮癬的討論仍在繼續，我們最終肯定會與您分享計劃。但今天我們真正感到興奮的是，當然，年底數據在其他指標方面的演變。我們還沒有準備好分享我們針對輕度至中度牛皮癬的計劃。

Our next question comes from Steve Scala of Cowen.

我們的下一個問題來自 Cowen 的 Steve Scala。

A couple of questions. Based on everything that has been said, it sounds as though the relatlimab data is not competitive with Opdivo plus Yervoy on efficacy. It might be on safety or am I misinterpreting? For instance, you mentioned adding to the armament area but not advancing it. You referred to many patients on monotherapy are not receiving I-O, but you didn't really refer to those on I-O, I-O. So I'm just curious what we should interpret and what full data be in the abstract on May 19?

有幾個問題。根據上述所有內容，聽起來 relatlimab 的數據在療效上與 Opdivo 加 Yervoy 不具有競爭力。這可能是出於安全考慮還是我誤解了？例如，你提到增加軍備領域，但沒有推進它。您提到許多接受單一療法的患者沒有接受 I-O，但您並沒有真正提到那些接受 I-O、I-O 的患者。所以我只是好奇我們應該解釋什麼以及 5 月 19 日摘要中的完整數據是什麼？

Second question on slide -- on Page 6. Of the 90% of products in the continuing business, should we think about Opdivo plus Yervoy comprising about 50% of that 90%?

幻燈片上的第二個問題——第 6 頁。在持續業務中的 90% 產品中，我們是否應該考慮 Opdivo 加 Yervoy 佔這 90% 的大約 50%？

Thank you, Steve. Let me just provide some perspective. So to answer your second question. As we've said, 90% of the business by 2025 being continuing business that excludes Revlimid and Pomalyst. In that 90%, we've said about 1/3 are the launch brands, the rest is the current online portfolio. We're not breaking that 70% down further into individual products. But I think what's important there is actually the strength of the emerging business for the remainder of the decade. And obviously, the launch brands become particularly important given that we're discussing 2025.

謝謝你，史蒂夫。讓我提供一些觀點。那麼回答你的第二個問題。正如我們所說，到 2025 年，90% 的業務都是持續性業務，不包括 Revlimid 和 Pomalyst。在這 90% 中，我們說過大約 1/3 是推出的品牌，其餘的是當前的在線產品組合。我們不會將這 70% 進一步細分為單個產品。但我認為重要的是新興業務在未來十年的實力。顯然，鑑於我們正在討論 2025 年，推出品牌變得尤為重要。

Let me just reiterate our enthusiasm for the relatlimab-Opdivo fixed-dose combination in melanoma. It is clear that we have a very well-established standard of care with O plus Y and long durability of response demonstrated over a long period of time. But I just want to, again, reiterate from an efficacy perspective, from a safety perspective, we're really excited to be able to show the data at ASCO. Samit?

讓我重申一下我們對 relatlimab-Opdivo 固定劑量組合治療黑色素瘤的熱情。顯然，我們對 O 加 Y 擁有非常完善的護理標準，並且在很長一段時間內表現出持久的反應。但我只是想再次從功效和安全的角度重申，我們非常高興能夠在 ASCO 上展示這些數據。薩米特？

And Steve, the point I would add is, look, we did not do a study of nivolumab plus relatlimab versus nivolumab plus ipilimumab. So it would be unfair to start comparing the data for the 2 trials.

史蒂夫，我要補充的一點是，我們沒有對納武單抗加 relatlimab 與納武單抗加伊匹單抗進行研究。因此開始比較兩次試驗的數據是不公平的。

Secondly, nivolumab plus ipilimumab, as Chris has said earlier, as Giovanni just said, has been established for a long time, so we have long-term data, overall survival data, response rate data. For relatlimab, we do not have the overall survival data as well as the response rate data. But we are excited to see where we stand with our overall progression-free survival data as compared to single-agent nivolumab. And you'll see that data very soon. And certainly, we can have a dialogue after that. But as Giovanni said, very pleased where we are and certainly looking forward to the evolution of the data as we go forward.

其次，nivolumab加ipilimumab，正如Chris之前所說，正如Giovanni剛才所說，已經建立了很長時間，所以我們有長期數據、總生存數據、緩解率數據。對於 relatlimab，我們沒有總體生存數據以及緩解率數據。但我們很高興看到與單藥納武單抗相比，我們的總體無進展生存數據處於什麼位置。您很快就會看到這些數據。當然，之後我們可以進行對話。但正如喬瓦尼所說，我們對目前的情況感到非常滿意，並且當然期待著我們前進過程中數據的演變。

Our next question comes from Luisa Hector of Berenberg.

我們的下一個問題來自貝倫貝格的路易莎·赫克托。

I wanted to return to Zeposia, please. I mean MS is a very tough market to be launching in Q2 COVID. I'm just wondering which patients are starting on Zeposia and do you expect that to evolve? And then on the UC indication, are you anticipating an AdCom? And could you update us on how you're preparing for launch?

我想回到 Zeposia，拜託。我的意思是，在新冠疫情第二季度，MS 是一個非常難推出的市場。我只是想知道哪些患者開始使用 Zeposia，您預計這種情況會發展嗎？然後，關於 UC 指標，您是否期待 AdCom？您能否向我們介紹一下您準備如何發布的最新情況？

Chris?

克里斯？

Sure. Let me start, and then I can maybe turn it over to Samit for the AdCom question. So very happy with the performance of Zeposia in MS, particularly as you point out, in light of the COVID environment. This was, as we had talked about last year, a market that was hit by COVID in terms of new patient volume being down. And obviously, this is a market that we are entering into relatively new for BMS. And so at the end of last year, we spent a considerable amount of time making sure we were engaging with customers in many cases for the first time. And then so our focus was continuing to do a few things. First, it was making sure that we were selling the profile for this, what we believe and clearly is being demonstrated in the data, #1 SP in this market. We've seen very good uptake in terms of written prescriptions here. Obviously, the dynamic pool of MS is relatively small, and we've seen most of the business at this point coming from switch patients, and we're continuing to get an increase in new patients who are coming on board as well. So we're very happy with that. And we would expect that to continue to evolve over time.

當然。讓我開始吧，然後我也許可以將 AdCom 問題轉交給 Samit。對 Zeposia 在多發性硬化症中的表現非常滿意，特別是正如您所指出的，考慮到新冠病毒環境。正如我們去年談到的那樣，這是一個受到新冠疫情打擊的市場，新患者數量下降。顯然，對於 BMS 來說，這是一個相對較新的市場。因此，在去年年底，我們花了相當多的時間來確保我們在許多情況下首次與客戶互動。然後我們的重點是繼續做一些事情。首先，它確保我們正在銷售此配置文件，我們相信並在數據中清楚地證明了這一點，即該市場中排名第一的 SP。我們看到書面處方的使用率非常高。顯然，多發性硬化症的動態池相對較小，目前我們看到大部分業務來自轉換患者，而且我們的新患者數量也在繼續增加。所以我們對此非常滿意。我們預計這種情況會隨著時間的推移而繼續發展。

And then obviously, as I mentioned in one of the previous questions, a big focus for us has been making sure that we continue to convert those written scripts into commercial dispense and ensuring a very smooth journey for patients in this market, and we've had a great acceleration there. So excited about what we're seeing so far, and we think we're on a very good trajectory for Zeposia in MS in the U.S. Samit?

顯然，正如我在前面的一個問題中提到的，我們的一大重點是確保我們繼續將這些書面處方轉化為商業配藥，並確保這個市場上的患者有一個非常順利的旅程，我們已經那裡有很大的加速度。我們對迄今為止所看到的感到非常興奮，我們認為 Zeposia 在美國 Samit 的多發性硬化症治療中正處於非常好的軌道上？

Yes. And just very briefly on ulcerative colitis. We are already at the end of April. Our PDUFA date is end of May. We have had nothing but a very good conversation with the FDA. So we have no knowledge of an AdCom for ulcerative colitis for Zeposia.

是的。非常簡單地介紹一下潰瘍性結腸炎。我們已經是四月底了。我們的 PDUFA 日期是五月底。我們與 FDA 進行了一次非常愉快的對話。因此，我們對 Zeposia 治療潰瘍性結腸炎的 AdCom 一無所知。

Thanks, Samit. I think we've got time for maybe 2 last ones. Keith, can we go to our next one, please?

謝謝，薩米特。我想我們還有時間討論最後兩個。基思，我們可以去下一場嗎？

Our next question comes from Dane Leone of Raymond James.

我們的下一個問題來自 Raymond James 的 Dane Leone。

Congratulations on the start to the year. I keep it, I guess, subtly brief. A question we get a lot from investors is how to think about the multiple myeloma franchise over the next couple of years and your market share collectively within that. Obviously, you have some moving pieces with Revlimid with some offsets to the backlog. But the specific question, I guess, is, where is your team looking in terms of some of the new agents that the clinical community is becoming more interested in, such as iberdomide? And how do you think that can move into a commercial setting as an offset to some of the headwinds you may face in the space?

祝賀新年伊始。我想，我把它保留得很簡短。我們從投資者那裡得到很多問題是如何考慮未來幾年的多發性骨髓瘤專營權以及您在其中的總體市場份額。顯然，來那度胺（Revlimid）有一些可移動的部分，並抵消了積壓的訂單。但我想，具體的問題是，您的團隊在臨床界越來越感興趣的一些新藥物（例如伊伯多胺）方面正在尋找什麼？您認為如何將其轉移到商業環境中，以抵消您在該領域可能面臨的一些不利因素？

Thank you, Dane. Samit?

謝謝你，丹恩。薩米特？

Yes. Thank you. So you've very correctly asked about multiple myeloma strategy. We are leaders in multiple myeloma, of course, continuing to build on the heritage of the image where we've pioneered in that space. We do have the broadest portfolio, and now we are beginning to see the results of that with the approval of Abecma. But the way we look at it is a 3-pronged approach. On one side, we have the CELMoDs, which have the potential to allow for us to replace the image over time with a near-term opportunity for iberdomide reading out this year in the fourth line plus setting. And then the second CELMoD 480 reading out in 2022.

是的。謝謝。所以你問的關於多發性骨髓瘤策略的問題非常正確。當然，我們是多發性骨髓瘤領域的領導者，我們將繼續發揚我們在該領域開創的形像傳統。我們確實擁有最廣泛的產品組合，現在我們開始看到 Abecma 批准的結果。但我們看待它的方式是三管齊下的。一方面，我們有 CELMoD，它有可能讓我們隨著時間的推移用伊伯多米特今年在第四行以上設置中讀出的近期機會來替換圖像。然後第二個 CELMoD 480 將於 2022 年讀出。

The second strategy is the BCMA targeting. Abecma already approved, and we have the investigation ongoing for T-cell engager as well as the ADC targeting. The third pillar is, of course, the combination. And you will see beginning this year already the studies of CELMoDs in the earlier line setting in the 1 to 2 prior lines of therapy. And then we will continue to build on the other combinations as well. So we feel overall really good about our position by having these multiple modalities, and we are confident that we can continue to build on our leadership position going forward in that space.

第二個策略是 BCMA 定位。 Abecma 已經獲得批准，我們正在對 T 細胞接合器以及 ADC 靶向進行調查。第三個支柱當然是組合。從今年開始，您將會看到 CELMoD 在 1 至 2 個先前治療線中的較早線設置中的研究。然後我們還將繼續以其他組合為基礎。因此，通過擁有這些多種模式，我們總體上對我們的地位感到非常滿意，並且我們有信心能夠繼續鞏固我們在該領域的領導地位。

Our last question comes from Navin Jacob of UBS.

我們的最後一個問題來自瑞銀集團的納文·雅各布。

Just 2, if I may. Just want to confirm that the -- on Eliquis, the $160 million true-up was actually -- was indeed a tailwind and not a headwind. And then finally, just on BD, test question for Giovanni, if I can. I noticed you have a somewhat new vertical for BMS and -- so far as having neuroscience. As you think about BD, what are the areas that you'll be looking to invest in? And roughly, how much are you looking to deploy on an annual basis for the next few years?

如果可以的話，就 2 個。只是想確認一下，對於 Eliquis，1.6 億美元的調整實際上是順風而不是逆風。最後，如果可以的話，就在 BD 上，給 Giovanni 測試一下問題。我注意到你們對 BMS 有一個有點新的垂直領域——就神經科學而言。當您考慮 BD 時，您會考慮投資哪些領域？大致而言，您希望在未來幾年每年部署多少資金？

Yes. Thanks, Navin. So let me just say very quickly. Yes, you are right. It is a tailwind, the $160 million, with respect to business development. Actually, what we are doing, what our teams are doing in neuroscience is really interesting. We obviously, over the last few years, built a very innovative model where through a network of partnerships primarily, a small team at BMS has been very successful in advancing an early portfolio that looks quite compelling at this point. So not a large area of focus from a sort of late-stage development for us yet, but an emerging franchise that could be important in the future.

是的。謝謝，納文。讓我快速地說一下。是的你是對的。 1.6 億美元對於業務發展來說是一個順風車。事實上，我們正​​在做的事情，我們的團隊在神經科學領域所做的事情非常有趣。顯然，在過去的幾年裡，我們建立了一個非常創新的模式，主要通過合作夥伴網絡，BMS 的一個小團隊非常成功地推進了目前看起來相當引人注目的早期產品組合。因此，對我們來說，這還不是後期開發的一個重點領域，而是一個在未來可能很重要的新興特許經營權。

As I said earlier, we are going to be looking at continuing to strengthen our portfolio depending on, obviously, the assets that we look at and are available across all of the areas where we have expertise. We haven't really given a target in terms of spend per year, but we've made it very clear that this is the #1 priority in terms of capital allocation strategy. The acquisition of MyoKardia last year is a really good example of the type of focus we want to continue to have going forward as a company. And I'll remind you, we have tremendous financial flexibility to be able to invest in the right opportunities and in the right science.

正如我之前所說，我們將考慮繼續加強我們的投資組合，這顯然取決於我們所關注的資產以及我們擁有專業知識的所有領域中可用的資產。我們還沒有真正給出每年支出的目標，但我們已經非常明確地表明，這是資本配置策略的第一要務。去年收購 MyoKardia 是我們希望作為一家公司繼續發展的重點的一個很好的例子。我要提醒您的是，我們擁有巨大的財務靈活性，能夠投資於正確的機會和正確的科學。

So with that, I would like to thank all of you for joining us today as we discuss this quarter. We delivered strong results consistent with our strategy. We've continued to grow revenue, execute on our launches and advance the pipeline. I'm really proud of what our teams have accomplished so far this year, including so many of the important milestones that have been discussed during the call. And as always, our team will be able to answer further questions you may have during the course of the day and the rest of the week. So have a good day, and thanks again to all of you for participating.

因此，我要感謝大家今天加入我們討論本季度。我們取得了符合我們戰略的強勁業績。我們繼續增加收入，執行我們的發布並推進管道。我對我們的團隊今年迄今為止所取得的成就感到非常自豪，包括電話會議期間討論的許多重要里程碑。與往常一樣，我們的團隊將能夠回答您在當天和本週剩餘時間內可能提出的進一步問題。祝您有美好的一天，再次感謝大家的參與。

This concludes today's call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。