施貴寶 (BMY) 2022 Q1 法說會逐字稿

Good day, and welcome to the Bristol-Myers Squibb 2022 First Quarter Results Conference Call. Today's conference is being recorded.

美好的一天，歡迎參加百時美施貴寶 2022 年第一季度業績電話會議。今天的會議正在錄製中。

At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead, sir.

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。

Thank you, Sergei, and good morning, everyone. Thanks for joining us this morning for our first quarter 2022 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 are Chris Boerner, our Chief Commercialization Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development.

謝謝你，謝爾蓋，大家早上好。感謝您今天早上參加我們的 2022 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。參加今天電話會議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'll note, we've posted slides to bms.com that you can follow along with for Giovanni and David's remarks. But before we get started, I'll read our forward-looking statements.

您將注意到，我們已將幻燈片發佈到 bms.com，您可以跟隨這些幻燈片了解喬瓦尼和大衛的言論。但在我們開始之前，我將閱讀我們的前瞻性聲明。

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 certain non-GAAP financial measures to the most comparable GAAP measures are available on bms.com.

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。 bms.com 上提供了某些非 GAAP 財務指標與最具可比性 GAAP 指標的調節表。

And so I'll hand over now to Giovanni.

現在我將把工作交給喬瓦尼。

Thank you, Tim, and good morning, everyone. Let's start with our first quarter performance on Slide 4. This is an important year for Bristol-Myers Squibb, and I'm pleased to share that we've had a strong start to 2022. In fact, just yesterday, the FDA-approved mavacamten or Camzyos. This is a first-in-class medicine for patients living with symptomatic obstructive HCM. It's an important milestone for patients who up until now had no options to treat the underlying cause of this disease. I'm proud that we're giving hope to patients and improving their quality of life.

謝謝蒂姆，大家早上好。讓我們從幻燈片 4 上的第一季度業績開始。對於百時美施貴寶來說，這是重要的一年，我很高興地告訴大家，我們在 2022 年有了一個良好的開端。事實上，就在昨天，FDA 批准了mavacamten 或 Camzyos。這是針對有症狀的梗阻性 HCM 患者的一流藥物。對於迄今為止無法治療這種疾病根本原因的患者來說，這是一個重要的里程碑。我很自豪我們為患者帶來希望並改善他們的生活質量。

It's also an important milestone for BMS. With U.S. approvals of Opdualag and Camzyos so far this year, we have significantly strengthened our new product portfolio. And we are on track to potentially launch 3 important new first-in-class medicines this year.

這對於BMS來說也是一個重要的里程碑。今年到目前為止，隨著 Opdualag 和 Camzyos 在美國獲得批准，我們顯著增強了我們的新產品組合。我們有望在今年推出 3 種重要的一流新藥。

Addition, strong commercial execution in the quarter resulted in solid year-over-year growth from our in-line products and new product portfolio. During the quarter, we saw the first entries of Revlimid generics in the U.S. and Europe. David will comment on our first quarter dynamics. But for the full year, U.S. entry expectations remain the same, while ex U.S. erosion is expected to be faster than previously anticipated.

此外，本季度強勁的商業執行力使我們的內嵌產品和新產品組合實現了同比穩健增長。本季度，我們在美國和歐洲看到了 Revlimid 仿製藥的首批上市。大衛將評論我們第一季度的動態。但就全年而言，美國市場的進入預期保持不變，而美國以外市場的侵蝕速度預計將快於此前的預期。

Overall, we grew revenue by 5% and delivered double-digit non-GAAP EPS growth compared to the same quarter last year. There is good momentum in our business, and our performance in Q1 validates that we are well prepared for the renewal of our portfolio with multiple catalysts across in-line products and new product portfolio to more than offset upcoming LOEs and drive growth through the decade. Our very strong financial position gives us significant flexibility as we continue to prioritize business development while paying down debt and expanding shareholder distributions.

總體而言，與去年同期相比，我們的收入增長了 5%，非 GAAP 每股收益實現了兩位數的增長。我們的業務勢頭良好，第一季度的業績證明我們已經為更新我們的產品組合做好了充分準備，通過在線產品和新產品組合的多種催化劑，足以抵消即將到來的 LOE 並推動未來十年的增長。我們非常強大的財務狀況為我們提供了巨大的靈活性，因為我們繼續優先考慮業務發展，同時償還債務和擴大股東分配。

Now let me turn to our scorecard on Slide 5 and provide some context around the important achievements of the quarter. We are making good progress against our milestones, which are central to delivering on our long-term strategy and growth as a company. Starting with the milestones we show during the quarter. Opdivo was approved in the U.S. in March as the first I-O agent to treat early-stage non-small cell lung cancer patients before surgery. This indication strengthens its profile in line and provides additional tailwind for growth.

現在讓我轉向幻燈片 5 上的記分卡，並提供有關本季度重要成就的一些背景信息。我們在里程碑方面取得了良好進展，這對於實現我們公司的長期戰略和發展至關重要。從我們在本季度展示的里程碑開始。 Opdivo 於 3 月在美國獲批，成為首個用於術前治療早期非小細胞肺癌患者的 I-O 藥物。這一跡象增強了其形象，並為增長提供了額外的動力。

While disappointed with the results of the Bempeg program, we are very pleased with the significant progress of our new product portfolio overall. Breyanzi is now approved in Europe, our second CAR T cell therapy approved in the EU. As you know, we've been planning to bring 3 important new products to market this year. So far, 2 of those new products, Opdualag and Camzyos received FDA approval. Many of our new products have significant expansion opportunities. For Opdualag, we recently initiated a pivotal study in colorectal cancer. And for deucravacitinib, we delivered a successful Phase II proof-of-concept result in lupus.

雖然對 Bempeg 計劃的結果感到失望，但我們對新產品組合整體的重大進展感到非常高興。 Breyanzi 現已在歐洲獲得批准，這是我們在歐盟獲得批准的第二種 CAR T 細胞療法。如您所知，我們計劃今年向市場推出 3 款重要的新產品。到目前為止，其中 2 個新產品 Opdualag 和 Camzyos 已獲得 FDA 批准。我們的許多新產品都有重大的擴展機會。對於 Opdualag，我們最近啟動了一項針對結直腸癌的關鍵研究。對於 deucravacitinib，我們在狼瘡方面取得了成功的 II 期概念驗證結果。

Looking to the future, the breadth of milestones ahead is exciting. One that we're looking forward to is the Milvexian Phase II data in secondary stroke prevention. We have decades of expertise in cardiovascular disease, and we believe this could be a medicine that treats an even broader population of patients than current oral anticoagulants. We expect to get Phase II data in-house around the middle of the year. And depending on the results, we plan to start Phase III trials later this year.

展望未來，未來的里程碑令人興奮。我們期待的一個是 Milvexian 在中風二級預防方面的二期數據。我們在心血管疾病方面擁有數十年的專業知識，我們相信這種藥物可以比目前的口服抗凝劑治療更廣泛的患者群體。我們預計將在今年年中左右獲得第二階段的內部數據。根據結果，我們計劃在今年晚些時候開始第三階段試驗。

Turning to our 3 new products on Slide 6. As I mentioned, in March, we received approval for Opdualag for the treatment of patients with unreceptible for metastatic melanoma. Opdualag is our first-in-class, fixed-dose, dual immunotherapy combination of nivolumab and the LAG-3 blocking agent antibody relatlimab. The combination of relatlimab and nivolumab demonstrated a clinically meaningful PFS and OS benefit. Opdualag marks the second approved I-O combination that we've delivered and demonstrates our continued scientific leadership in I-O.

轉向幻燈片 6 上的 3 個新產品。正如我提到的，三月份，我們獲得了 Opdualag 的批准，用於治療無法接受的轉移性黑色素瘤患者。 Opdualag 是我們的同類首創、固定劑量、雙重免疫療法組合，由 nivolumab 和 LAG-3 阻斷劑抗體 relatlimab 組成。 relatlimab 和 nivolumab 的組合顯示出具有臨床意義的 PFS 和 OS 益處。 Opdualag 標誌著我們交付的第二個獲得批准的 I-O 組合，並展示了我們在 I-O 領域持續的科學領先地位。

While we are still in the early days, I can say that the Opdualag launch is going very well. We believe this medicine has the opportunity to become a new standard of care for melanoma patients. In addition to melanoma, Opdualag has the potential for new indications. And we are exploring important opportunities in lung, liver and colorectal cancers.

雖然我們仍處於早期階段，但我可以說 Opdualag 的發布進展非常順利。我們相信這種藥物有機會成為黑色素瘤患者的新護理標準。除了黑色素瘤之外，Opdualag 還具有新適應症的潛力。我們正在探索肺癌、肝癌和結直腸癌的重要機會。

Turning now to our just FDA-approved mavacamten or Camzyos. The benefit of Camzyos for patients with symptomatic obstructive HCM were further reinforced with the exciting VALOR data presented at ACC this month. We're launching Camzyos in the U.S. and look forward to receiving EU approval and launching international with future indications to come.

現在談談我們剛剛獲得 FDA 批准的 mavacamten 或 Camzyos。本月 ACC 上公佈的令人興奮的 VALOR 數據進一步強化了 Camzyos 對有症狀的梗阻性 HCM 患者的益處。我們將在美國推出 Camzyos，並期待獲得歐盟批准並在國際市場推出，未來將有跡象表明。

Finally, we continue to be excited about the opportunity for the deucravacitinib. As you know, we have an FDA PDUFA date in September for psoriasis. We believe that psoriasis patients need better oral options. And this asset has demonstrated superior efficacy compared to the oral standard of care with a favorable safety and tolerability profile.

最後，我們仍然對 deucravacitinib 的機會感到興奮。如您所知，FDA 的牛皮癬 PDUFA 日期為 9 月。我們相信牛皮癬患者需要更好的口服選擇。與口服標準護理相比，該資產已表現出卓越的功效，並具有良好的安全性和耐受性。

During the first quarter, we also delivered a successful Phase II proof-of-concept result in lupus, positioning us to start Phase III studies later this year in a disease with a very high unmet need. Importantly, the lupus data continues to show the consistent and differentiated safety profile of a selective TYK2 inhibitor. We plan to share comprehensive data with the scientific community at upcoming congress this year.

在第一季度，我們還成功交付了狼瘡的 II 期概念驗證結果，使我們能夠在今年晚些時候開始針對這種需求未得到滿足的疾病的 III 期研究。重要的是，狼瘡數據繼續顯示選擇性 TYK2 抑製劑具有一致且差異化的安全性。我們計劃在今年即將召開的大會上與科學界分享全面的數據。

With our upcoming FDA PDUFA date in the third quarter, Phase III trials already underway in psoriatic arthritis and a proof-of-concept achieved in lupus and additional phase II trials ongoing, including in IBD, our confidence in the potential of this program continues to grow.

隨著我們即將在第三季度獲得 FDA PDUFA 日期，銀屑病關節炎的 III 期試驗已經開始，狼瘡的概念驗證也已完成，另外的 II 期試驗（包括 IBD）正在進行中，我們對該項目的潛力繼續充滿信心。生長。

Now turning to Slide 7. Thanks to the hard work, dedication and strong execution by our employees, I am confident in our ability to deliver on our strategy and more than offset key LOEs by continuing the growth of our in-line products with $8 billion to $10 billion in incremental sales and delivering $10 billion to $13 billion of revenue expected from our new product portfolio by 2025. Our strong clinical performance further derisks our launch portfolio. And as a result, we have confidence in our ability to deliver the $25 billion plus in nonrisk-adjusted revenue in 2029. We have a strong foundation in place. And as the renewal of our portfolio gains further traction this year, I am confident in the potential of our company.

現在轉向幻燈片 7。由於我們員工的辛勤工作、奉獻精神和強大的執行力，我對我們實現戰略的能力充滿信心，並通過繼續以 80 億美元的收入增長我們的在線產品來抵消關鍵的 LOE。到 2025 年，我們的新產品組合預計將實現 100 億美元的增量銷售額，並帶來 100 億至 130 億美元的收入。我們強勁的臨床表現進一步降低了我們推出產品組合的風險。因此，我們對在 2029 年實現超過 250 億美元的非風險調整收入的能力充滿信心。我們擁有堅實的基礎。隨著今年我們產品組合的更新進一步受到關注，我對我們公司的潛力充滿信心。

Now I'll turn it over to David.

現在我把它交給大衛。

Thank you, Giovanni, and welcome again to our first quarter earnings call. I'm pleased to turn to Slide 9 to discuss our top line performance. Unless otherwise stated, I will discuss sales performance on an underlying basis, which excludes the impact of foreign exchange translation.

謝謝喬瓦尼，歡迎再次參加我們的第一季度財報電話會議。我很高興轉向幻燈片 9 來討論我們的營收表現。除非另有說明，我將在基本基礎上討論銷售業績，其中不包括外匯換算的影響。

Total company revenues in the quarter exceeded $11.6 billion, growing 7% year-over-year. This was driven by strong double-digit sales of our in-line and new product portfolio, partially offset by our recent LOEs. Let's take a closer look at our new product portfolio performance on Slide 10. In the first quarter, the new product portfolio contributed $350 million in revenue, more than doubling revenue versus prior year. With the combination of factors, including the usual year-end buying patterns impacting sequential performance, we remain confident in the growth potential of the new product portfolio.

該季度公司總收入超過 116 億美元，同比增長 7%。這是由我們的在線和新產品組合強勁的兩位數銷售額推動的，但部分被我們最近的 LOE 所抵消。讓我們仔細看看幻燈片 10 上的新產品組合表現。第一季度，新產品組合貢獻了 3.5 億美元的收入，比去年同期增長了一倍多。綜合多種因素，包括影響連續業績的通常年終購買模式，我們對新產品組合的增長潛力仍然充滿信心。

The first-in-class approvals of Opdualag and yesterday's FDA approval of Camzyos further strengthened our confidence in the new product portfolio. We also look forward to our upcoming PDUFA date for deucravacitinib in September, which would deliver another first-in-class medicine for patients with the opportunity to deliver more than $4 billion in nonrisk-adjusted revenue in 2029. These initial approvals are just the beginning as many of these new medicines have significant expansion opportunities into additional indications.

Opdualag 的一流批准以及 Camzyos 昨天獲得 FDA 批准，進一步增強了我們對新產品組合的信心。我們還期待即將於 9 月份推出的 deucravacitinib 的 PDUFA 日期，這將為患者提供另一種一流的藥物，並有機會在 2029 年實現超過 40 億美元的非風險調整收入。這些初步批准只是一個開始因為許多新藥都有機會拓展到其他適應症。

Now let's look at our expanded more diversified business by therapeutic area. Turning to our solid tumor performance on Slide 11. Opdivo and Yervoy continued their growth trajectory, growing double digits versus prior year. This is driven by continued demand for our newly launched indications and our core indications.

現在讓我們看看我們按治療領域擴展的更加多元化的業務。轉向我們在幻燈片 11 上的實體瘤表現。Opdivo 和 Yervoy 繼續保持增長軌跡，與去年相比增長了兩位數。這是由對我們新推出的適應症和核心適應症的持續需求推動的。

In the U.S., Opdivo grew double-digit versus prior year, driven by demand in first-line lung, renal and gastric cancer as well as adjuvant esophageal and bladder cancers. Outside the U.S., first quarter year-over-year revenues increased double digit. This strong growth was primarily driven by expanded access in emerging markets as well as demand for new indications in developed markets as we continue to secure reimbursement.

在美國，受到一線肺癌、腎癌、胃癌以及輔助食管癌和膀胱癌需求的推動，Opdivo 與去年相比實現了兩位數增長。在美國以外，第一季度收入同比增長兩位數。這種強勁的增長主要是由於新興市場的准入範圍擴大以及發達市場對新適應症的需求（隨著我們繼續獲得報銷）所推動。

Looking forward, we expect continued growth of Opdivo from our new and expanding indications. With the launch of Opdualag in mid-March, we are pleased to be the only company with 3 approved I-O agents. While early days in the launch, we generated approximately $6 million in sales, half of which was demand and the other half stocking. We are encouraged by the initial feedback suggesting the potential for Opdualag to be a new standard of care for patients with metastatic melanoma, and I look forward to providing more updates as the year progresses.

展望未來，我們預計 Opdivo 會因新適應症和不斷擴大的適應症而持續增長。隨著 Opdualag 於 3 月中旬推出，我們很高興成為唯一一家擁有 3 個經批准的 I-O 代理的公司。在推出初期，我們創造了大約 600 萬美元的銷售額，其中一半來自需求，另一半來自庫存。初步反饋表明 Opdualag 有可能成為轉移性黑色素瘤患者的新護理標準，我們對此感到鼓舞，我期待著隨著時間的推移提供更多更新。

Now let's move to our growing cardiovascular portfolio on Slide 12. I'll start with Eliquis, which continues to grow globally, with revenues up 14% year-over-year. In the U.S., sales increased 12% versus prior year, driven primarily by total prescription growth of 10%. Internationally, sales were strong, up 17% versus a year ago. This strong double-digit growth was primarily driven by increased share across key markets, and the brand continues to be the #1 NOAC in multiple countries.

現在讓我們轉向幻燈片 12 上不斷增長的心血管產品組合。我將從 Eliquis 開始，該公司在全球範圍內持續增長，收入同比增長 14%。在美國，銷售額較上年增長 12%，這主要是由於總處方量增長 10%。國際市場銷售強勁，較去年同期增長 17%。這種強勁的兩位數增長主要是由主要市場份額的增加推動的，並且該品牌仍然是多個國家排名第一的 NOAC。

Turning to our expanded portfolio. I'm really excited about the approval of mavacamten now known as Camzyos for patients with symptomatic obstructive hypertrophic cardiomyopathy or oHCM. We plan to leverage BMS's existing CV leadership, building our strong expertise and relationship, focused initially at top HCM centers. Our field teams are excited to bring this product to patients in the U.S., and Chris can provide more details on our go-to-market strategy in the Q&A session.

轉向我們擴大的產品組合。我對 mavacamten（現在稱為 Camzyos）獲得批准用於治療有症狀的梗阻性肥厚性心肌病或 oHCM 患者感到非常興奮。我們計劃利用 BMS 現有的 CV 領導地位，建立強大的專業知識和關係，最初重點關注頂級 HCM 中心。我們的現場團隊很高興將該產品帶給美國的患者，克里斯可以在問答環節中提供有關我們的上市策略的更多詳細信息。

Now let's turn our attention over to a few of our hematology products on Slide 13, starting with Revlimid. Sales in the quarter were nearly $2.8 billion. Revenues were primarily impacted by generic entry. During Q1, we saw generics enter the U.S. later than expected entry and so far at a modest pace. As mentioned last quarter, we expect variability quarter-to-quarter due to the uncertainty of how generic players will enter the market, though there is no change to our outlook for the U.S. Revlimid this year and beyond, we expect favorability we saw in Q1 to reverse in Q2. And internationally, generics launch broadly across Europe in mid-February and erosion has been faster than expected. As a result, we now expect full year global sales to be approximately $9 billion to $9.5 billion. Based upon U.S. phasing and ex U.S. dynamics, we expect second quarter global revenues to be approximately $2 billion.

現在讓我們將注意力轉向幻燈片 13 上的一些血液學產品，從 Revlimid 開始。該季度銷售額接近 28 億美元。收入主要受到仿製藥進入的影響。在第一季度，我們看到仿製藥進入美國的時間晚於預期，但到目前為止進展緩慢。正如上季度提到的，由於仿製藥廠商如何進入市場的不確定性，我們預計季度與季度之間會出現變化，儘管我們對美國來那度胺今年及以後的前景沒有變化，但我們預計第一季度會受到青睞在第二季度出現逆轉。在國際上，仿製藥於 2 月中旬在歐洲廣泛上市，侵蝕速度比預期要快。因此，我們現在預計全年全球銷售額約為 90 億至 95 億美元。根據美國的分階段發展和美國以外的動態，我們預計第二季度全球收入約為 20 億美元。

Pomalyst global revenues grew from 9% versus prior year. Global revenues continued to be driven by volume and market share gains as patients move to earlier lines of treatment and extending duration of treatment.

Pomalyst 全球收入較去年增長 9%。隨著患者轉向早期治療並延長治療持續時間，全球收入繼續受到銷量和市場份額增長的推動。

Now moving to Reblozyl, which generated revenues of $156 million in the quarter. Sales were up 41% versus prior year, primarily driven by continued demand in ESA refractory MDS patients. In the U.S. to date, we have robust on-label share in RS-positive patients. We're seeing encouraging trends in the reduction of time in the switch from ESA failures, which is also supported by NCCN guidelines. We have also made progress in physicians uptrading a patient's dose to ensure sustained duration and benefit. Our focus remains on patient identification and dose titration for optimal outcomes.

現在轉向 Reblozyl，該季度收入為 1.56 億美元。銷售額比上年增長 41%，這主要是由於 ESA 難治性 MDS 患者的持續需求推動的。迄今為止，在美國，我們在 RS 陽性患者中擁有強勁的標籤份額。我們看到 ESA 故障轉換時間縮短的令人鼓舞的趨勢，這也得到了 NCCN 指南的支持。我們在醫生提高患者劑量以確保持續時間和益處方面也取得了進展。我們的重點仍然是患者識別和劑量滴定以獲得最佳結果。

And outside the U.S., Reblozyl continues to grow with increased share in both MDS and beta-thalassemia associated anemia. We have now launched in 6 countries outside the U.S. and expect to launch in more markets in 2022. Moving to cell therapy launches, Abecma and Breyanzi. Abecma generated revenues of $67 million in the first quarter. As expected, sales were largely similar to the fourth quarter of 2021 as demand continues to be robust, and worked hard to expand capacity. We are on track to expand capacity in the middle of this year to be able to help more patients with highly refractory multiple myeloma.

在美國以外的地區，Reblozyl 繼續增長，在 MDS 和 β 地中海貧血相關貧血中的份額不斷增加。目前，我們已在美國以外的 6 個國家/地區推出產品，預計 2022 年將在更多市場推出。轉向細胞療法的推出，Abecma 和 Breyanzi。 Abecma 第一季度營收為 6700 萬美元。正如預期，由於需求持續強勁，並努力擴大產能，銷售額與 2021 年第四季度基本相似。我們有望在今年年中擴大產能，以幫助更多高度難治性多發性骨髓瘤患者。

As it relates to Breyanzi, sales in the quarter were $44 million. Sales were driven primarily by demand in the U.S., while physicians continue to recognize Breyanzi's best-in-class profile. We are very pleased with the recent EU approval for Breyanzi in third-line plus large B-cell lymphoma and look forward to launching in select markets in 2022.

就 Breyanzi 而言，該季度的銷售額為 4400 萬美元。銷售主要由美國的需求推動，而醫生們繼續認可 Breyanzi 的一流形象。我們對 Breyanzi 最近獲得歐盟批准用於治療三線及大 B 細胞淋巴瘤感到非常高興，並期待於 2022 年在特定市場推出。

Additionally, we are preparing for the U.S. launch of Breyanzi in second-line large B cell lymphoma in June and are ramping up capacity in order to treat more patients.

此外，我們正準備於 6 月份在美國推出用於治療二線大 B 細胞淋巴瘤的 Breyanzi，並正在提高產能以治療更多患者。

Moving to our immunology product summary on Slide 14. Orencia sales grew 6% versus prior year due to expanded U.S. sales, driven by increased market share in the U.S. As it relates to Zeposia, global sales in the quarter were $36 million, doubling sales compared to prior year. Sequentially in the U.S., we saw encouraging demand growth that was offset primarily by buying patterns from prior quarter and higher gross-to-net impacts related to patient access and ulcerative colitis. We are pleased with the awareness and perception of Zeposia in UC and are encouraged by the strong increase in new patient starts.

轉到幻燈片 14 上的免疫學產品摘要。由於美國市場份額增加，導緻美國銷售額擴大，Orencia 銷售額比去年同期增長 6%。就 Zeposia 而言，本季度全球銷售額為 3600 萬美元，是去年同期銷售額的兩倍到上一年。接下來，在美國，我們看到了令人鼓舞的需求增長，但這主要被上一季度的購買模式以及與患者就診和潰瘍性結腸炎相關的總淨影響增加所抵消。我們對 Zeposia 在 UC 中的認知和認知感到高興，並對新患者開始的強勁增長感到鼓舞。

We continue to work further expanding volume while strengthening access and reimbursement and expect to have increased contribution from UC in the second half of this year and expanding in 2023. Internationally, Zeposia continues to secure reimbursement in other markets for MS as well as obtain additional reimbursement for the newly approved UC indication last quarter. Lastly, as we continue to broaden our immunology portfolio, launch plans are already underway to prepare for deucravacitinib's upcoming PDUFA date in September.

我們繼續努力進一步擴大銷量，同時加強准入和報銷，預計今年下半年 UC 的貢獻將增加，並在 2023 年擴大。在國際上，Zeposia 繼續確保 MS 在其他市場的報銷，並獲得額外報銷上季度新批准的 UC 適應症。最後，隨著我們繼續擴大我們的免疫學產品組合，推出計劃已經在進行中，為 deucravacitinib 即將於 9 月份上市的 PDUFA 日期做準備。

Now, let's turn to our first quarter P&L on Slide 15. As noted recently, we changed the presentation of our non-GAAP results. Along with other pharmaceutical companies, we no longer exclude significant research and development charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights. These charges have been included in our GAAP results, and there's no impact to the economics of our business. Going forward, we will now include these previously specified charges in both GAAP and non-GAAP results as a new line item called acquired in-process research and development as well as capture the previously specified income in our OI&E line item.

現在，讓我們轉向幻燈片 15 上的第一季度損益表。正如最近指出的，我們更改了非 GAAP 業績的呈現方式。與其他製藥公司一樣，我們不再排除與資產收購或第三方知識產權許可相關的預付款或或有里程碑付款所產生的巨額研發費用或其他收入。這些費用已包含在我們的 GAAP 業績中，並且對我們業務的經濟效益沒有影響。展望未來，我們現在將把這些先前指定的費用納入 GAAP 和非 GAAP 業績中，作為一個名為“收購的在製品研發”的新項目，並將先前指定的收入納入我們的 OI&E 項目中。

In the quarter, operating expenses, excluding acquired in-process research and development increased versus prior year, primarily due to increased MS&A driven by differences in timing of spend in the prior year as well as investments in our new product portfolio. Net charges of $280 million consisting of acquired in-process R&D charges offset by licensing income are primarily driven by upfront milestone payments associated with the Immatics and Dragonfly licensing agreements.

本季度，運營費用（不包括收購的正在進行的研發）與上年相比有所增加，這主要是由於上年支出時間差異以及對新產品組合的投資導致管理與管理費用增加。 2.8 億美元的淨費用包括被許可收入抵消的收購的在製品研發費用，主要是由與 Immatics 和 Dragonfly 許可協議相關的預付款里程碑付款驅動的。

The first quarter effective tax rate was impacted by earnings mix. Even with this new financial presentation and the $0.10 impact from the inclusion of acquired in-process R&D and previously specified income, our strong performance in the quarter allowed us to grow non-GAAP EPS 13% versus last year. Excluding this, the new presentation chain of non-GAAP EPS would have grown 18%.

第一季度有效稅率受到盈利組合的影響。即使有了新的財務報表，以及收購的正在進行的研發和之前指定的收入帶來的 0.10 美元的影響，我們本季度的強勁表現仍然使我們的非 GAAP 每股收益比去年增長了 13%。排除這一點，新的非公認會計原則每股收益將增長 18%。

Now moving to the balance sheet and capital allocation on Slide 16. Cash flow generation for the company remained strong. Cash flow from operations in the quarter was approximately $3.8 billion. We ended the quarter in a strong liquidity position with approximately $15 billion in cash and marketable securities. Our capital allocation priorities remain unchanged. BD continues to be a top priority, and we remain committed to continued debt reduction and returning capital to shareholders.

現在轉到幻燈片 16 上的資產負債表和資本配置。公司的現金流生成仍然強勁。本季度運營現金流量約為 38 億美元。本季度結束時，我們的流動性狀況良好，擁有約 150 億美元的現金和有價證券。我們的資本配置重點保持不變。 BD 仍然是重中之重，我們仍然致力於持續削減債務並向股東返還資本。

And in the quarter, we executed a $5 billion accelerated share repurchase program. Approximately 65 million shares or 85% of the $5 billion aggregate repurchase price were delivered to the company in the quarter. The ASR will settle over the next couple of quarters, and we remain opportunistic about future share repurchases.

在本季度，我們執行了 50 億美元的加速股票回購計劃。本季度大約有 6500 萬股股票或 50 億美元回購總額的 85% 交付給了該公司。 ASR 將在接下來的幾個季度內解決，我們仍然對未來的股票回購持機會態度。

Now turning to our 2022 non-GAAP guidance on Slide 17. As you know, we guide based upon prevailing exchange rates at the time we report the results. We're updating our top line guidance to be in line to prior year, primarily due to movements in foreign exchange, reflecting the spot rate of the dollar today and faster erosion of Revlimid outside the U.S.

現在轉向幻燈片 17 上的 2022 年非 GAAP 指導。如您所知，我們的指導基於報告結果時的現行匯率。我們正在更新我們的營收指引，使其與上一年保持一致，這主要是由於外匯變動，反映了當前美元的即期匯率以及來那度胺在美國以外的更快侵蝕。

Recent LOE product guidance is also being changed to reflect the updated Revlimid outlook in the range of $9 billion to $9.5 billion. So FX headwinds impact our entire portfolio. The outlook for in-line products and the new product portfolio remains unchanged. This reflects the strong performance and confidence in our future growth drivers. We now expect total operating expenses, excluding in-process R&D, to decline in the low single digits versus prior year, driven primarily by cost discipline and the impact of foreign exchange.

最近的 LOE 產品指南也發生了變化，以反映更新後的 Revlimid 前景（90 億至 95 億美元）。因此，外匯逆風會影響我們的整個投資組合。內嵌產品和新產品組合的前景保持不變。這反映了我們強勁的業績和對未來增長動力的信心。我們現在預計，不包括正在進行的研發的總運營費用將比去年低個位數下降，這主要是受成本控制和外匯影響的推動。

Excluding the change in financial presentation that we've adopted for non-GAAP earnings, there is no change to our outlook for non-GAAP EPS for the year. With the impact of certain acquired in-process R&D and licensing income that are now included in non-GAAP EPS, our new range of $7.44 to $7.74. This change is driven by the previously announced $0.10 impact from the actuals in the first quarter, an additional $0.11 related to the buyout of future royalty obligations from mavacamten that occurred in April.

排除我們對非 GAAP 收益採用的財務列報的變化，我們對今年非 GAAP 每股收益的展望沒有變化。受某些收購的正在進行的研發和許可收入（現已包含在非公認會計原則每股收益中）的影響，我們的新範圍為 7.44 美元至 7.74 美元。這一變化是由之前宣布的第一季度實際影響 0.10 美元造成的，另外 0.11 美元與 4 月份發生的 mavacamten 未來特許權使用費義務的買斷有關。

Before we move on to Q&A, I want to thank our colleagues around the world to continue to deliver strong commercial, clinical and financial results. And I'm really excited for what lies ahead.

在我們進行問答之前，我要感謝我們世界各地的同事繼續取得強勁的商業、臨床和財務成果。我對即將發生的事情感到非常興奮。

I'll now turn it back over to Tim and Giovanni for Q&A.

現在我將把它轉回蒂姆和喬瓦尼進行問答。

Thanks, David. Sergei, could we go to our first question, please?

謝謝，大衛。謝爾蓋，我們可以回答第一個問題嗎？

Our first question comes from Chris Schott from JPMorgan.

我們的第一個問題來自摩根大通的克里斯·肖特。

Two for me. First, can you maybe talk about Camzyos, if I'm pronouncing that right, and the echo monitoring requirement there? It seems like it's a fairly kind of long program. I'm just wondering how you see that impacting any uptake the drug could have?

給我兩個。首先，如果我沒說錯的話，您能談談 Camzyos 以及那裡的迴聲監控要求嗎？看起來這是一個相當長的程序。我只是想知道您如何看待這對藥物可能產生的影響？

And the second question for me was on Milvexian and just the read across from the Bayer Factor XIa data we saw last month. I guess specific question would be, can you just talk about the attractiveness of Afib as a category for the Factor XIa's? And is that a focus for Bristol? Or is your focus more in markets where there currently isn't, I guess, Factor Xa usage? So any color there would be appreciated.

我的第二個問題是關於 Milvexian 以及我們上個月看到的拜耳因子 XIa 數據的解讀。我想具體的問題是，您能談談心房顫動作為因子 XIa 類別的吸引力嗎？這是布里斯托爾的重點嗎？或者您是否更關注目前尚未使用 Xa 因子的市場？所以任何顏色都會受到讚賞。

Thank you, Chris. I'll ask Chris to answer your question on Camzyos, and then Samit will comment on Milvexian.

謝謝你，克里斯。我將請 Chris 回答您關於 Camzyos 的問題，然後 Samit 將對 Milvexian 發表評論。

Thanks for the question. Since this is the first question on Camzyos, let me just say at the outset that we're incredibly excited to be launching Camzyos. This is an important new medicine for obstructive HCM patients. And for those of you who are at ACC, there's palpable excitement and anticipation of this drug. So this is a great opportunity for patients.

謝謝你的提問。由於這是關於 Camzyos 的第一個問題，所以我首先要說的是，我們對推出 Camzyos 感到非常興奮。這是治療阻塞性 HCM 患者的重要新藥。對於 ACC 的人來說，對這種藥物有明顯的興奮和期待。所以這對患者來說是一個很好的機會。

Let me say a couple of things on just the REMS in general, and then I'll get to your question on the echo monitoring. We've been working with Simon's team and the FDA on the design of this REMS and with customers on how we would execute against it for a number of months. We view obviously the REMS as important because it ensures that patients are able to be treated safely, that they get on the right dose and that they're able to ultimately get the full benefit for Camzyos. There are 2 key components as you think about this REMS. There's a titration period, which is all about monitoring patients to ensure they get the right dose. This is largely again conceptually to how cardiologists manage hypertension.

讓我就 REMS 的一般情況說幾句話，然後我將回答您關於迴聲監測的問題。幾個月來，我們一直在與 Simon 的團隊和 FDA 合作設計該 REMS，並與客戶合作研究如何執行它。顯然，我們認為 REMS 很重要，因為它確保患者能夠得到安全治療，獲得正確的劑量，並最終能夠從 Camzyos 獲得全部益處。當您想到這個 REMS 時，有兩個關鍵組成部分。有一個滴定期，其目的是監測患者以確保他們獲得正確的劑量。這在很大程度上又是心髒病專家如何治療高血壓的概念。

And then the second component is ensuring eligibility of giving background medications. As we look across both of these 2 key components together, we see the requirements for the REMS is manageable, generally fitting, as I referenced earlier, to the treatment approach for cardiac patients, and we don't see them as a barrier to adoption.

第二個組成部分是確保給予背景藥物的資格。當我們一起審視這兩個關鍵組成部分時，我們發現 REMS 的要求是可以管理的，正如我之前提到的，通常適合心髒病患者的治療方法，並且我們不認為它們是採用的障礙。

Now with respect to the echo monitoring period specifically, we obviously consulted customers as we were working through the design of the REMS, and they don't see it as a concern for a couple of reasons. First, the requirements of this monitoring period are relatively minimal. You have to get an LVEF and an LVOT reading. That can be done with your local physicians. So for those patients who are being treated in centers of excellence, they can go back to their cardiologists, local cardiologist office to fulfill those requirements.

現在，具體到迴聲監測週期，我們在設計 REMS 時顯然諮詢了客戶，他們並不認為這是一個問題，原因有幾個。首先，這個監測週期的要求相對較低。您必須獲得 LVEF 和 LVOT 讀數。這可以與您當地的醫生一起完成。因此，對於那些在卓越中心接受治療的患者，他們可以回到他們的心髒病專家、當地心髒病專家辦公室來滿足這些要求。

Second, you have to remember, patients would be coming back a couple of times a year anyway for echos. And a number of patients would be coming back much more frequently for symptom management. So physician visits every 3 months is not seen as particularly burdensome. And the last thing I would highlight is a very important point, which is that patients are going to be highly motivated to work their way through this period. As we saw with the 4 study patients are highly motivated to stay on drug, they feel better on Camzyos. And so we think there's going to be strong motivation on their part to work through these requirements. So net-net, this is something we'll be obviously educating customers on, but we don't see this as a barrier to use.

其次，您必須記住，無論如何，患者每年都會回來幾次以獲得迴聲。許多患者會更頻繁地回來接受症狀管理。因此，每 3 個月看一次醫生並不算特別麻煩。我要強調的最後一件事是非常重要的一點，那就是患者將非常積極地努力度過這一時期。正如我們在 4 名研究患者中看到的那樣，他們非常積極地繼續用藥，他們在使用 Camzyos 後感覺更好。因此，我們認為他們會有很強的動力來滿足這些要求。因此，網絡，這顯然是我們將向客戶進行的教育，但我們不認為這是使用的障礙。

Thanks, Chris. Thanks for that. And Chris, from JPM, for your question on Milvexian. I think first of all, we are truly excited about that medicine as well. And we look forward to getting the data in-house in the middle of the year. The read-through from the Bayer presentation, I would say is that it further strengthens our confidence in the mechanism of action as well as provides a further proof-of-concept that inhibiting Factor XIa is a safe way to provide further anticoagulation or antithrombotic therapies for patients who really need it. As it comes to what indications we'll be pursuing, we'll continue to work with our partner, Janssen, to really define those once the data are in-house. And we can look at the data, the dose, the ways of administering the drug. And all in all, we'll be able to share that with you once we are ready with the data and the read-throughs. Thank you.

謝謝，克里斯。感謝那。來自摩根大通的克里斯回答了你關於 Milvexian 的問題。我認為首先，我們也對這種藥物感到非常興奮。我們期待在今年年中獲得內部數據。我想說的是，通讀拜耳的演示文稿，它進一步增強了我們對作用機制的信心，並提供了進一步的概念證明，即抑制 XIa 因子是提供進一步抗凝或抗血栓治療的安全方法為真正需要的患者。至於我們將追求哪些跡象，我們將繼續與我們的合作夥伴 Janssen 合作，一旦數據掌握在內部，我們將真正定義這些跡象。我們可以查看數據、劑量和給藥方式。總而言之，一旦我們準備好數據和通讀內容，我們就可以與您分享。謝謝。

Thanks, Samit. Sergei can we go to the next question, please?

謝謝，薩米特。謝爾蓋，我們可以進入下一個問題嗎？

Chris Shibutani, Goldman Sachs.

克里斯·澀谷，高盛。

Congratulations on the approval on Camzyos as well. Perhaps can you talk about 2 issues: one, relating to access and the other in terms of time lines for which you feel that the physicians are going to get more comfortable with dosing. Perhaps can you update us on your expectations for access timing relative to this approval and with the early phases of the rollout and again, on timing on when they're going to be educating physicians and expecting them to get more comfortable with the regimen and the REMS.

也祝賀 Camzyos 獲得批准。也許您可以談談兩個問題：一是與可及性有關，二是與時間線有關，在該時間線內您認為醫生會對劑量感到更加滿意。也許您可以向我們介紹一下您對與本次批准相關的訪問時間以及推出的早期階段的期望，以及他們何時對醫生進行教育並期望他們對治療方案和治療方案感到更加滿意的時間快速眼動睡眠監測。

Thank you, Chris. Chris?

謝謝你，克里斯。克里斯？

Sure. So 2 very good questions. So let me start with access. In general, we anticipate the majority of the Camzyos patients are going to have very good access for this therapy. Remember, about half of the patients who are obstructive HCM are covered by commercial and Medicare. And we think access in this patient population is going to be particularly good. And we expect initially a disproportionate share of our use is going to come from this patient population. Now remember, like virtually all specialty medicines, Camzyos is not going to be on formulary day 1. We will plan to cover these patients on bridge programs for the roughly 4 to 6 weeks that are going to be required to work through the exceptions process. But we've built strong patient support programs to assist these patients during the sign, and we expect minimal barriers for these patients during this initial period. And then, of course, once Camzyos is on formulary, we would expect access to be much more straightforward.

當然。這是兩個非常好的問題。那麼讓我從訪問開始。總的來說，我們預計大多數 Camzyos 患者將有很好的機會接受這種治療。請記住，大約一半的梗阻性 HCM 患者享受商業保險和醫療保險。我們認為，在這一患者群體中獲得治療的機會將會特別好。我們預計最初我們的使用中不成比例的份額將來自該患者群體。現在請記住，像幾乎所有專科藥物一樣，Camzyos 不會在處方的第一天出現。我們將計劃在大約 4 到 6 週的過渡計劃中為這些患者提供保障，這將需要完成例外流程。但我們已經建立了強大的患者支持計劃，以在症狀期間為這些患者提供幫助，並且我們預計這些患者在最初階段遇到的障礙會最小化。當然，一旦 Camzyos 進入處方集，我們預計訪問會更加簡單。

Now for Medicare patients, we expect that share is going to grow over time as any affordability challenges there get resolved. Initially, the opportunity will be mainly in the low-income subsidy patients. But then in the broader population, use will expand as additional support becomes available to address any affordability issues there.

現在，對於醫療保險患者來說，隨著時間的推移，隨著負擔能力方面的挑戰得到解決，這一比例將會增加。最初，機會將主要集中在低收入補貼患者身上。但隨著額外的支持可以解決那裡的任何負擔能力問題，在更廣泛的人群中，使用將會擴大。

With respect to your second question on time lines for dosing education, we actually think that's going to be relatively rapid. A few things to keep in mind. Number one is we work through this label. I referenced that we were working with customers on how we would execute against the REMS. So many of the customers, particularly in centers of excellence, which will be the primary focus at launch are already roughly familiar with the dosing requirements here. And obviously, the initial focus of our commercial efforts are going to be in these centers of excellence. So we think the understanding of the dosing requirements and the REMS more generally are going to be very good at launch there. And then we're going to be targeting a much broader audience. In fact, the majority of potential obstructive HCM patients with our launch efforts, we're staffed to do that, and those education efforts are underway beginning today.

關於您關於劑量教育時間表的第二個問題，我們實際上認為這將相對較快。有幾點需要記住。第一是我們通過這個標籤來工作。我提到我們正在與客戶合作研究如何執行 REMS。許多客戶，特別是卓越中心的客戶，將成為發佈時的主要關注點，已經大致熟悉這裡的劑量要求。顯然，我們商業努力的最初重點將放在這些卓越中心。因此，我們認為對劑量要求和 REMS 更普遍的理解將有助於在那裡啟動。然後我們將瞄準更廣泛的受眾。事實上，大多數潛在的梗阻性 HCM 患者都參與了我們的啟動工作，我們配備了人員來做到這一點，並且這些教育工作從今天開始就正在進行中。

Thanks, Chris. Sergei, can we go to the next one, please?

謝謝，克里斯。謝爾蓋，我們可以轉到下一個嗎？

Geoff Meacham from Bank of America.

美國銀行的傑夫·米查姆。

I just had a couple on the new product launches. So first on Breyanzi, I just wanted to get kind of an update of where you guys -- what you guys think drives a real inflection. If you had any update as well on the manufacturing, that would be helpful. And then on Zeposia, can you just talk a little bit about the drag on access, just timing for formulary additions, et cetera. Just kind of wondering the drivers of an inflection for that brand as well.

我剛剛參加了新產品發布會。首先，關於 Breyanzi，我只是想了解一下你們的最新情況——你們的想法推動了真正的變化。如果您還有有關製造的任何更新，那將會有所幫助。然後在 Zeposia 上，您能談談訪問方面的阻力、增加處方的時間等等嗎？只是想知道該品牌變化的驅動因素。

Thank you, Geoff. Chris?

謝謝你，傑夫。克里斯？

Sure. So let me talk about Breyanzi, first, then I'll touch on Zeposia. So Breyanzi, we're happy with the continued performance that we saw in the quarter. We were up obviously sequentially. We're seeing within our existing indication continued strong interest from physicians in using the product. Patient enrollments from activated accounts were up nicely in the quarter. We saw a nice increase in apheresis patients and that translated into growth in Breyanzi's overall class share, which is now roughly 20% to 25%. Particularly important from my perspective is that Breyanzi continues to be seen as the best-in-class asset here. And so that gives us confidence not only in our existing indication, but obviously, we're very much looking forward to a label expansion into the second-line setting for this asset, which continues to be on track, and Samit can speak to that in the second half of the year.

當然。首先讓我談談 Breyanzi，然後我會談談 Zeposia。 Breyanzi，我們對本季度的持續表現感到滿意。我們顯然是連續上升的。我們在現有的適應症中看到醫生對使用該產品的持續濃厚興趣。本季度激活賬戶的患者註冊人數大幅增加。我們看到單採患者數量大幅增加，這也轉化為 Breyanzi 整體班級份額的增長，目前約為 20% 至 25%。從我的角度來看，特別重要的是 Breyanzi 仍然被視為這裡最好的資產。因此，這不僅讓我們對現有的適應症充滿信心，而且顯然，我們非常期待該資產的標籤擴展到二線設置，該資產繼續走上正軌，薩米特可以對此表示下半年。

With respect to manufacturing, as we've said previously, obviously, that's a big focus for us. We have consistently said that we're -- our focus is on expanding that capacity by the middle of the year to be ready for that second-line launch, and those efforts continue to be on track.

至於製造，正如我們之前所說，顯然這是我們的重點。我們一直表示，我們的重點是在今年年中之前擴大產能，為二線產品的推出做好準備，而且這些努力仍在繼續進行中。

As for Zeposia, again, I think we are happy with the continued progress that we've made with Zeposia. As David referenced, we had a few dynamics in the quarter with respect to gross to net and inventory. That said, as we look at that product, particularly in UC, which is obviously important for the long-term growth of the product, there are 2 things that are going to be critically important for the success of the product.

至於 Zeposia，我認為我們對 Zeposia 所取得的持續進展感到高興。正如大衛提到的，我們在本季度的總淨值和庫存方面有一些動態。也就是說，當我們審視該產品時，特別是在 UC 領域，這對於產品的長期增長顯然很重要，有兩件事對於產品的成功至關重要。

First, we've got to, as you referenced, improve access; and second, we've got to drive volumes. Since both of those things co-travel, maybe I'll just give you a quick update on both. With respect to access, we have very broad formulary access today. And in fact, we've seen the quality of that access improve this year relative to last year. But as we expected, the majority of patients for Zeposia in UC still have multiple step edits. And so we've got to continue to improve access for these patients. And the way we will do that is by driving volume. And on that front, we made good progress in the quarter. Patient starts were up about 30% in Q1 relative to Q4. We continue to expand our user base nicely. And importantly, we continue to drive intent to prescribe, all of which we think set us up for continued volume growth.

首先，正如您提到的，我們必須改善訪問；其次，我們必須提高銷量。由於這兩件事是一起旅行的，也許我會給你一個關於這兩件事的快速更新。關於獲取途徑，我們今天擁有非常廣泛的處方獲取途徑。事實上，我們已經看到今年的訪問質量相對於去年有所提高。但正如我們預期的那樣，大多數 UC 患者接受 Zeposia 治療時仍需進行多步編輯。因此，我們必須繼續改善這些患者的就診機會。我們要做到這一點的方法是提高銷量。在這方面，我們在本季度取得了良好進展。第一季度的患者起始數量比第四季度增加了約 30%。我們繼續很好地擴大我們的用戶群。重要的是，我們繼續推動處方意願，我們認為所有這些都為我們的銷量持續增長奠定了基礎。

Now the majority of those patients when they come on therapy are going to initially be triaged to our bridge program. So what we've got to do this year is, first, we've got to convert those patients to commercial drug where possible. For patients who have better access, we need to convert them over from our bridge program on to commercial drug, and there's a big focus this year to do that. And then second, obviously, we've got to continue to drive new patient starts. So as I look at the quarter, I think we made good headway. We've got more work to do. But as we begin to achieve success, particularly in moving those patients from bridge to commercial, you'll see greater volume of sales coming from UC, and that will set us up for continued success later this year and into '23.

現在，大多數接受治療的患者將首先被分類到我們的過渡計劃中。因此，我們今年要做的是，首先，我們必須盡可能將這些患者轉為使用商業藥物。對於有更好機會的患者，我們需要將他們從過渡計劃轉為商業藥物，今年的重點是做到這一點。其次，顯然，我們必須繼續推動新的患者開始治療。因此，當我審視本季度時，我認為我們取得了良好的進展。我們還有更多工作要做。但隨著我們開始取得成功，特別是在將這些患者從橋樑轉向商業化方面，您將看到來自 UC 的銷量更大，這將為我們在今年晚些時候和 23 年繼續取得成功奠定基礎。

Sergei, can we go to the next one, please?

謝爾蓋，我們可以轉到下一個嗎？

Seamus Fernandez, Guggenheim.

謝默斯·費爾南德斯，古根海姆。

Great. So the first one really is on Milvexian. I wanted to drill into your comments earlier on the call with regard to the opportunity and SSP and your knowledge there. Feedback that we have gotten from thought leaders and experts in the space, view this as a bit of a riskier indication, more in the context of the patients that get recruited and the interactions that can occur between clopidogrel and aspirin that perhaps could confuse a little bit of the data as it relates to Factor XI. So I wanted to just get a better understanding of how you guys are controlling for that. There are genetic factors that impact clopidogrel, bleeding risk, things like that as well as the efficacy of clopidogrel. So just wanted to get a sense of how you are managing for that, whether you're stratifying for it or perhaps looking at looking at that on -- after effect.

偉大的。所以第一個確實是在 Milvexian 上。我想在早些時候的電話會議上深入了解您對機會和 SSP 的評論以及您的知識。我們從該領域的思想領袖和專家那裡得到的反饋認為，這是一個風險更大的跡象，更多的是在招募的患者以及氯吡格雷和阿司匹林之間可能發生的相互作用的背景下，這可能會有點令人困惑與因子 XI 相關的數據位。所以我想更好地了解你們是如何控制這一點的。遺傳因素會影響氯吡格雷、出血風險等以及氯吡格雷的療效。因此，我只是想了解一下您是如何做到這一點的，無論您是對其進行分層，還是在考慮後續效果。

And then the second question on mavacamten. Obviously, I think the price may be surprised to the upside a little bit at $90,000 annually. That's quite a wide spread between that result and the ICER evaluation of less than $15,000 a year. Obviously, can you just comment on that differential and how you hope to get beyond that with additional clinical studies?

然後是關於 mavacamten 的第二個問題。顯然，我認為價格可能會意外上漲，達到每年 90,000 美元。該結果與 ICER 評估的每年不到 15,000 美元的差距相當大。顯然，您能否評論一下這種差異以及您希望如何通過額外的臨床研究來超越這一差異？

Thank you. Thank you, Seamus. So let me just make a comment at the beginning. We've been very clear with respect to the ICER assessment of mavacamten with the fact we didn't think it was scientifically accurate and not based on solid data and methodology. So Chris will give you his perspective about the mavacamten value and price. Before that, though, Samit would answer your question on Milvexian SSP.

謝謝。謝謝你，西莫。因此，讓我在開始時發表評論。對於 ICER 對 mavacamten 的評估，我們非常明確，我們認為它在科學上不准確，也不是基於可靠的數據和方法。因此，Chris 將為您提供他對 mavacamten 價值和價格的看法。不過，在此之前，Samit 會在 Milvexian SSP 上回答您的問題。

Thank you, Giovanni, and thanks, Seamus, for your question. On Milvexian, as you know, that SSP trial is ongoing. It's more than 2,000 patients that have been enrolled in the study. And we'll have a readout in the middle of the year as I said earlier. We have the background therapy of clopidogrel as well as aspirin. Clopidogrel which is given in the first month and ASA continues for the next up to 3 months. With that data, we will be getting all the PK data as well as all of the safety data, and we'll be able to then analyze if there are any interactions. Having said that, we've done quite a number of DDI studies, and we do not see drug-drug interactions as issues.

謝謝喬瓦尼，也謝謝謝莫斯提出的問題。如您所知，在 Milvexian 上，SSP 試驗正在進行中。已有超過 2,000 名患者參加了這項研究。正如我之前所說，我們將在年中公佈結果。我們有氯吡格雷和阿司匹林的背景治療。第 1 個月給予氯吡格雷，接下來 3 個月繼續給予 ASA。有了這些數據，我們將獲得所有 PK 數據以及所有安全數據，然後我們將能夠分析是否存在任何相互作用。話雖如此，我們已經做了相當多的 DDI 研究，我們並不認為藥物間相互作用是問題。

And of course, the overall safety that we will get from this study, combined with the data from the TKI study that we've already done, we'll then define how we proceed further. So since the data are almost around the corner, let's wait for that and not speculate on how the application will be in the SSP study. And certainly, when the data are available and then presented at medical conferences in the future, we can have a further dialogue on that. Thank you. And Chris?

當然，我們將從這項研究中獲得的總體安全性，結合我們已經完成的 TKI 研究的數據，然後我們將確定如何進一步進行。因此，既然數據即將到來，我們就拭目以待吧，不要猜測該應用程序在 SSP 研究中的表現如何。當然，當數據可用並在未來的醫學會議上展示時，我們可以就此進行進一步的對話。謝謝。克里斯呢？

Thanks, Seamus. I think Giovanni addressed the question on ICER. So as it relates to the specific price for Camzyos, we price this product very much consistently with how we price products generally, which is looking at a variety of factors and notably the value that the drug brings to patients in the health care system with a strong focus on ensuring that we are providing rapid and sustained access for patients. Remember with Camzyos, this is the first therapy that effectively targets the source of obstructive HCM. So there really aren't any clinically comparable therapies here.

謝謝，西莫。我認為 Giovanni 在 ICER 上回答了這個問題。因此，由於它與 Camzyos 的具體價格相關，我們對該產品的定價與我們一般產品定價的方式非常一致，我們考慮了多種因素，特別是該藥物為醫療保健系統中的患者帶來的價值重點關注確保我們為患者提供快速、持續的服務。請記住，Camzyos 是第一種有效針對阻塞性 HCM 根源的療法。所以這裡確實沒有任何臨床可比的療法。

You've got largely ineffective, nonspecific products like beta and calcium channel blockers that are relatively old and inexpensive. And then you've got more effective, but highly invasive procedures like myectomy and septal ablation. These procedures alone can be upwards of $100,000 to $150,000. And then you've got ancillary costs associated with those. And remember, they don't cure the disease. So you've got ongoing multiyear costs associated with these products as well. So it's a fairly broad range of prices. Where we netted out here, we think is a price that, as I mentioned before, reflects the value of the product. We don't see any incremental concerns with respect to access. And as I referenced in the previous question, we have a robust suite of programs and resources that are in the market to help address any patients or caregivers to support access for this product.

你擁有的產品基本上是無效的、非特異性的，例如β通道阻滯劑和鈣通道阻滯劑，它們相對陳舊且便宜。然後你就可以進行更有效但高度侵入性的手術，例如心肌切除術和間隔消融術。僅這些程序的費用就可能高達 100,000 至 150,000 美元。然後你就會產生與這些相關的輔助成本。請記住，它們不能治愈這種疾病。因此，您還需要承擔與這些產品相關的持續多年的成本。所以它的價格範圍相當廣泛。正如我之前提到的，我們在這裡得出的結論是，價格反映了產品的價值。我們沒有看到任何關於訪問方面的增量擔憂。正如我在上一個問題中提到的，我們在市場上擁有一套強大的計劃和資源，可以幫助任何患者或護理人員支持使用該產品。

Let's go to the next question, Sergei.

讓我們討論下一個問題，謝爾蓋。

Evan Seigerman from BMO.

BMO 的埃文·塞格曼。

And congrats on the approval last night. So I just wanted to touch on Revlimid. I know you -- David, you had mentioned some color on the call in your prepared remarks. But aside from FX, can you characterize any other potential balance at risk to the guidance over the remainder of the year? Just trying to get a sense of kind of the erosion curve OUS and what we should be thinking about. And now that we're into the quarter, can you really characterize what you're seeing OUS and kind of maybe give us some more color there?

並祝賀昨晚獲得批准。所以我只想談談來那度胺（Revlimid）。我知道你——大衛，你在準備好的講話中提到了電話會議的一些色彩。但除了外匯之外，您能否描述一下今年剩餘時間裡任何其他可能對指引構成風險的潛在平衡？只是想了解一下侵蝕曲線 OUS 以及我們應該考慮什麼。現在我們已經進入了這個季度，您能否真正描述一下您所看到的 OUS 情況，並為我們提供更多信息？

And just on one housekeeping item. On that royalty obligation you bought back for mavacamten, any impact we should be thinking about in our models?

而且只是一件家務用品。關於您為 mavacamten 回購的特許權使用費義務，我們應該在我們的模型中考慮任何影響嗎？

Yes. Thanks, Evan, for the question. And on Revlimid, you really need to think about it in the context of the 2 markets, the U.S. and OUS. And as I said in my prepared remarks, for the U.S., the generic entry was later than we had anticipated and the erosion has been modest. So -- and as a result of that, we think that will come out in the second quarter, and that's why we provided guidance on the second quarter for Revlimid overall of $2 billion in Q2.

是的。謝謝埃文提出的問題。對於 Revlimid，您確實需要在美國和 OUS 這兩個市場的背景下考慮。正如我在準備好的發言中所說，對於美國來說，仿製藥的進入比我們預期的要晚，而且侵蝕程度也很小。因此，我們認為這將在第二季度公佈，這就是為什麼我們在第二季度為 Revlimid 提供了總計 20 億美元的第二季度指導。

As you think about the full year, outside the U.S. we had multiple generics enter in Europe in mid-February, and that erosion has been faster than we anticipated. And based upon that erosion that we're seeing, that's why we changed the full year guidance on Revlimid between $9 billion and $9.5 billion. As you think about longer-term Revlimid going forward, you may recall that we provided a guidance of about $2 billion to $2.5 billion per year over the next couple of years. And as we head into next year, since the erosion is a little faster this year, we'll probably be at the lower end of that range of around $2 billion for next year. So that's on Revlimid.

考慮到全年情況，在美國以外的地區，我們有多種仿製藥於 2 月中旬進入歐洲，而且這種侵蝕速度比我們預期的要快。基於我們所看到的侵蝕，這就是我們將 Revlimid 的全年指導調整為 90 億美元至 95 億美元的原因。當您考慮未來 Revlimid 的長期發展時，您可能還記得我們提供了未來幾年每年約 20 億至 25 億美元的指導。當我們進入明年時，由於今年的侵蝕速度要快一些，因此明年我們可能會處於 20 億美元左右的範圍的下限。這就是來那度胺（Revlimid）。

And mavacamten, there was a minor royalty that we were able to retire that obligation. And it'll be a slight improvement to our gross margins, but we don't guide gross margins for our products overall. A low single-digit royalty obligation that we're able to expire.

和mavacamten，有一個小版稅，我們能夠取消這項義務。這將使我們的毛利率略有改善，但我們不會指導我們產品的整體毛利率。我們可以到期的低個位數特許權使用費義務。

Thanks. Can we go to the next one, please, Sergei?

謝謝。謝爾蓋，我們可以轉到下一篇嗎？

Andrew Baum, Citi.

安德魯·鮑姆，花旗銀行。

A couple of questions, please. Assuming AXIOMATIC-SSP result positive, I'm curious as to which clinical settings you'd actively avoid with Milvexian, given that OD inhibits one of the pathways, intrinsic pathways, ELIQUIS uses have failed in mechanical heart valves. I'm just looking for some guidance not where you want to go, but where you would be disinclined to go? .

請教幾個問題。假設 AXIOMATIC-SSP 結果呈陽性，我很好奇您在使用 Milvexian 時會積極避免哪些臨床環境，因為 OD 會抑制其中一種途徑（內在途徑），ELIQUIS 在機械心臟瓣膜中的使用已失敗。我只是在尋找一些指導，不是你想去哪裡，而是你不願意去哪裡？ 。

And then second is given the accumulating long-term follow-up on the plaque psoriasis disease indications expand, I wonder whether you care to comment on any imbalances for zoster or thrombosis in that collected data that I'm sure you shared with the agency.

其次是對斑塊型銀屑病疾病適應症擴大的長期隨訪，我想知道您是否願意對收集的數據中帶狀皰疹或血栓形成的任何不平衡發表評論，我確信您與該機構分享了這些數據。

Thank you, Andrew. Let me ask Samit to answer both of your questions.

謝謝你，安德魯。讓我請薩米特回答你們的兩個問題。

Thank you, Andrew, and like the new flavor of the question on the indications for Milvexian, asking the same question different way, but I think the answer will remain the same for you that we're not disclosing at this time what indications we are going to pursue or exclude. We will have to make those decisions once we have the dose as well as our conversations with our partners, and of course, in conversations with the regulatory agencies in terms of how we will conduct the studies, what control arms will be used, et cetera. So certainly, would be happy to have that dialogue once we are there with the data as well as the decisions.

謝謝你，安德魯，喜歡關於 Milvexian 適應症的問題的新風格，以不同的方式問同樣的問題，但我認為答案對你來說將保持不變，因為我們目前沒有透露我們的適應症是什麼去追求或者排斥。一旦我們掌握了劑量以及與合作夥伴的對話，當然還有與監管機構就如何進行研究、將使用什麼控制臂等進行對話，我們就必須做出這些決定。因此，一旦我們掌握了數據和決策，我們肯定會很高興進行對話。

On deucravacitinib, you're absolutely right. We are continuing to be very confident in the profile of the medicine. We have the data, of course, from POETYK 1 and POETYK 2 with long-term follow-ups now. We've conducted studies in psoriasis in China and Japan as well, which continue to support the overall profile. Additional data, of course, from psoriatic arthritis Phase II studies, SLE study that we've talked about as well, all continue to support the overall safety profile that we have seen in terms of the very specific inhibition of the TYK2 pathway without an impact on the JAK pathway. So the differentiation continues. And those are the data that we have provided from the psoriasis perspective to the agencies and looking forward to that launch in moderate-to-severe psoriasis in September of this year.

關於 deucravacitinib，你是完全正確的。我們仍然對該藥物的概況充滿信心。當然，我們現在有來自 POETYK 1 和 POETYK 2 的數據以及長期隨訪數據。我們還在中國和日本進行了銀屑病研究，這繼續支持整體概況。當然，來自銀屑病關節炎 II 期研究、我們也討論過的 SLE 研究的其他數據都繼續支持我們在 TYK2 通路的非常特異性抑制方面看到的整體安全性，而沒有影響在 JAK 途徑上。所以分化還在繼續。這些是我們從銀屑病角度向各機構提供的數據，並期待今年 9 月推出針對中度至重度銀屑病的數據。

Sergei, can we go to the next one?

謝爾蓋，我們可以進入下一個嗎？

Steve Scala, Cowen.

史蒂夫·斯卡拉，考恩。

I'd like to follow up on the Revlimid trajectory. It looks like the second half Revlimid revenue is expected to be about $4.2 billion to $4.7 billion. That implies a flat to up performance versus the second quarter. Can you discuss why it will be up in -- flat to up in H2 if pressure has intensified in both the U.S. and OUS? That's the first question.

我想跟進 Revlimid 的發展軌跡。預計下半年Revlimid收入預計約為42億至47億美元。這意味著與第二季度相比，業績持平到上升。您能否討論一下，如果美國和海外地區的壓力都加劇，為什麼下半年該指數會持平甚至上漲？這是第一個問題。

The second question is, and I apologize for splitting hairs, but Milvexian data was expected in the first half. Now it's midyear. That is a modest change. But has there been some sort of delay maybe because of events? This isn't necessarily meant directed at Bristol, but it seems in this industry, midyear is always the third quarter and the third quarter is always September. So any color would be appreciated.

第二個問題是，我為吹毛求疵表示歉意，但米爾維先的數據預計會在上半年出現。現在已經是年中了。這是一個適度的改變。但是否因為事件而出現某種延遲？這不一定是針對布里斯托爾的，但在這個行業中，年中總是第三季度，而第三季度總是九月。所以任何顏色都會受到讚賞。

Thank you, Steve. Let me answer the second question, and then I'll ask David to answer your question on Revlimid. There is no change to the time lines for Milvexian. So the study is on track, and we look forward to updating you as soon as the data is in-house, David?

謝謝你，史蒂夫。讓我回答第二個問題，然後我會請 David 回答你關於來那度胺 (Revlimid) 的問題。米爾維西安的時間線沒有變化。所以這項研究正在步入正軌，我們期待著在內部獲得數據後立即向您更新，大衛？

Yes. And Steve, thanks for the question on Revlimid. The thing that's important to remember in the U.S., we only have 1 generic entry in the first half of the year. And then we have multiple generics that were entering in the second half of the year. So that's why the phasing is from quarter-to-quarter. And it can shift, as I was saying between because the generic entry will be in the September time frame. So depending on how quickly that comes into the market will impact the phasing of the product quarter-to-quarter. But you will see more generics in the U.S. in the second half of the year.

是的。史蒂夫，感謝您提出有關 Revlimid 的問題。需要記住的是，在美國，我們上半年只有 1 個通用條目。然後我們有多種仿製藥在今年下半年上市。這就是為什麼分階段是按季度進行的。正如我所說，它可能會發生變化，因為通用條目將在 9 月的時間範圍內進行。因此，產品進入市場的速度將影響產品每季度的階段性。但今年下半年你會在美國看到更多的仿製藥。

Sergei, can we go to the next question, please?

謝爾蓋，我們可以進入下一個問題嗎？

Luisa Hector, Berenberg.

路易莎·赫克托，貝倫貝格。

I wanted to ask you whether we can compare and contrast the Zeposia ramp with the potential ramp of deucravacitinib. Do you anticipate a similar sort of challenge, I guess, in terms of access and volume as you bring that product to market? And really, it's a question about how we should moderate our ramp, our launch ramp for deucravacitinib.

我想問您我們是否可以比較和對比 Zeposia 的坡度與 deucravacitinib 的潛在坡度。我想，當您將該產品推向市場時，您是否預計在訪問和數量方面會遇到類似的挑戰？事實上，這是一個關於我們應該如何調整我們的斜坡，我們的 deucravitinib 的發射斜坡的問題。

And on M&A, your comments still consistent commentary. But given some of the changes to valuations of some of the targets, I just wondered whether any of the dialogue is also shifting. Are you finding more companies approaching you? Is there more dialogue around collaborations on early-stage pipeline, just any shift in the dialogue.

關於併購，您的評論仍然是一貫的評論。但考慮到一些目標估值的一些變化，我只是想知道對話是否也在發生變化。您是否發現更多公司正在接近您？圍繞早期管道的合作是否有更多對話，對話是否有任何轉變。

Let me just answer the first -- the second question on M&A, and then Chris will answer your question on deucrava. So -- and let me just reiterate that our focus on M&A has always been there. It's the central pillar of our capital allocation strategy. It's a really important part of our innovation strategy. We've actually had a number of deals that we've executed in the last few months, which really confirms a very proactive approach to business development and more broadly. And as a result of that, that will continue to guide us in the future.

讓我回答第一個問題——關於併購的第二個問題，然後克里斯將回答你關於 deucrava 的問題。所以，讓我重申一下，我們對併購的關註一直存在。這是我們資本配置策略的核心支柱。這是我們創新戰略的一個非常重要的部分。實際上，我們在過去幾個月中執行了許多交易，這確實證實了我們在更廣泛的業務發展方面採取了非常積極主動的方法。因此，這將繼續指導我們的未來。

With respect to your question about whether we are seeing any change, our experience is that whenever there is some type of realignment in market values, it always takes a little bit of time for those values to really be the values that boards of biotech companies look at in terms of their valuation.

關於你關於我們是否看到任何變化的問題，我們的經驗是，每當市場價值出現某種類型的調整時，這些價值總是需要一點時間才能真正成為生物技術公司董事會所認為的價值就其估值而言。

Having said that, of course, values were extremely high. They're somewhat realigned. And then I'll conclude by saying that every company is a bit of a different story, and you have to really look at it one at a time. But we are confident in the ability to continue to bring new innovation into the company through a combination of business development strategies that go from partnership and collaboration, in-licensing and potential acquisitions. Chris?

話雖如此，當然，價值非常高。他們有些重新調整。最後我要說的是，每家公司的故事都有所不同，你必須一次真正地審視一個公司。但我們對通過合作夥伴關係、合作、許可和潛在收購等業務發展戰略的結合，繼續為公司帶來新創新的能力充滿信心。克里斯？

Yes. So thanks, Luisa, for the question. Just a couple of things. I would say at a high level, there are -- there are some important similarities between UC and psoriasis. Volume is going to be important to gain access over time. This is a market that, while it is less competitively intense than what you see in UC, particularly in the oral setting, it is a market that has been historical heavily managed. Now there are some important differences as well. While psoriasis is heavily managed, we have seen a number of national payers have moved from highly restricted access to more open formulary management over the last few years. That's good for new entrants.

是的。謝謝路易莎提出的問題。只是幾件事。我想說，從高水平來看，UC 和銀屑病之間有一些重要的相似之處。隨著時間的推移，數量對於獲得訪問量將變得非常重要。儘管這個市場的競爭不如你所看到的 UC 激烈，特別是在口腔領域，但它是一個歷史上一直受到嚴格管理的市場。現在也存在一些重要的差異。儘管銀屑病受到嚴格管理，但我們看到過去幾年中許多國家付款人已從嚴格限制的准入轉向更開放的處方管理。這對於新進入者來說是件好事。

We also know that many patients are going to be covered on plans that have open access when we launch. Again, that's an important opportunity for a new entrant like deucravacitinib. But for the remainder of covered lives, it's going to be important as we've been discussing with Zeposia to build volume over time so that we can work with payers to gain more of a favorable access position. So there are some similarities between the 2 and then a couple of important differences as well.

我們還知道，當我們啟動時，許多患者將受到開放獲取的計劃的覆蓋。對於 deucravitinib 這樣的新進入者來說，這又是一個重要的機會。但對於剩餘的承保生活來說，這將很重要，因為我們一直在與 Zeposia 討論隨著時間的推移增加數量，以便我們可以與付款人合作以獲得更多有利的准入地位。因此，兩者之間有一些相似之處，但也有一些重要的區別。

Sergei, can we go to the next one?

謝爾蓋，我們可以進入下一個嗎？

Tim Anderson, Wolfe Research.

蒂姆·安德森，沃爾夫研究中心。

This is Adam on behalf of Tim. So first on TYK2, can you talk about the commercial potential in psoriasis with under 2 different scenarios? The first being, if you get a black box warning and the second is without that warning. If you do get a black box warning, would it be safe to assume that sales in psoriasis could be something like half of what they would be if you had a clean label?

這是亞當代表蒂姆。首先，您能談談 TYK2 在兩種不同情況下治療牛皮癬的商業潛力嗎？第一個是，如果您收到黑框警告，第二個是沒有該警告。如果您確實收到黑框警告，是否可以安全地假設牛皮癬的銷售額可能只有清潔標籤時的一半？

And then secondly, just real quick on LAG-3. When will we get the next round of important data that will inform our success outside of melanoma not just Phase III results but also from earlier trials that are ongoing.

其次，LAG-3 的速度非常快。我們什麼時候才能獲得下一輪重要數據，這些數據將告訴我們在黑色素瘤之外的成功，不僅包括 III 期結果，還包括正在進行的早期試驗。

Thanks, Adam. This is Giovanni. So on TYK2 let me just start by saying we are increasingly confident in the potential of that program as I mentioned earlier with PDUFA date in September for psoriasis ongoing Phase III study citing arthritis. And then, of course, the SLE proof-of-concept readout earlier this year, together with ongoing Phase II studies in a number of other indications, including IBD. So the prospects for the program continue to strengthen as we go forward. We've answered that question on regulatory outcomes, specifically with respect to the label a number of times. But let me ask Chris to give you his perspective again. And then Samit will comment on the LAG-3 program.

謝謝，亞當。這是喬瓦尼。因此，在 TYK2 上，我首先要說的是，我們對該計劃的潛力越來越有信心，正如我之前提到的，PDUFA 日期為 9 月，正在進行銀屑病 III 期研究，引用關節炎。當然，還有今年早些時候發布的 SLE 概念驗證，以及正在進行的針對包括 IBD 在內的許多其他適應症的 II 期研究。因此，隨著我們的前進，該計劃的前景繼續增強。我們已經多次回答了有關監管結果的問題，特別是有關標籤的問題。但讓我請克里斯再次向您提供他的觀點。然後 Samit 將評論 LAG-3 計劃。

Sure. Thanks, Adam, for the question. So first, I'm not going to speculate on the black box scenario. As we've said consistently we're going to continue to operate under the perspective of the most likely scenario and the scenario that we believe is most supported by the data, which is that deucravacitinib has unique mechanism of action consistent with all of the preclinical and clinical data that we have.

當然。謝謝亞當提出這個問題。首先，我不會猜測黑匣子場景。正如我們一直所說的那樣，我們將繼續在最有可能的情況和我們認為最有數據支持的情況的角度下進行操作，即 deucravacitinib 具有與所有臨床前研究一致的獨特作用機制。以及我們擁有的臨床數據。

And so our focus from a commercial standpoint, while we, of course, scenario plan various versions of a label that's going to be the operating plan that we go as the most likely case. And so we're still very much focused on leveraging the data from the 2 Phase III studies that we have that clearly show clinical data that is superior both from an efficacy standpoint and safety superiority to Otezla which is the only branded oral in the market today.

因此，我們從商業角度關注，當然，我們也會對標籤的各種版本進行情景規劃，這將是我們最有可能採取的運營計劃。因此，我們仍然非常注重利用我們擁有的 2 項 III 期研究的數據，這些數據清楚地表明，從功效角度和安全性角度來看，臨床數據均優於 Otezla，Otezla 是當今市場上唯一的品牌口服藥物。

And given that efficacy, we believe we have a very strong case for establishing deucravacitinib as the branded oral of choice here. Launch preparations are well underway. We have a great team already in the field from a medical standpoint. The home office team has been staffed and is up and running. We're in the process of hiring the sales force.

鑑於這種功效，我們相信我們有充分的理由將 deucravacitinib 確立為此處首選的品牌口服藥物。發射準備工作正在順利進行。從醫學角度來看，我們已經在該領域擁有一支優秀的團隊。家庭辦公室團隊已配備人員並已啟動並運行。我們正在招聘銷售人員。

So our going position continues to be consistent with deucravacitinib as a unique mechanism of action. And we think we have the clinical profile and the team in place to deliver on establishing this product as the branded oral of choice, Samit.

因此，我們的立場仍然與 deucravacitinib 作為一種獨特的作用機制保持一致。我們認為，我們擁有臨床概況和團隊，可以將該產品打造成首選品牌口服產品 Samit。

So Thanks, Chris. And Adam, just on the Opdualag, because LAG-3 is obviously being developed as a fixed-dose combination with Nivolumab, we have several studies ongoing not only as BMS-sponsored trial, but also through investigator-initiated trials. And through those investigator-initiated trials, there will be continued evolution of the data that will be coming through, even including from this ASCO itself. So you will see the data continuing to come out at various conferences through either our trials or through the ISRs that are being conducted. And of course, then the Phase IIIs will start to read out over the coming years.

謝謝，克里斯。 Adam，就 Opdualag 而言，因為 LAG-3 顯然正在開發為與 Nivolumab 的固定劑量組合，我們正在進行多項研究，不僅作為 BMS 贊助的試驗，而且還通過研究者發起的試驗進行。通過這些研究者發起的試驗，所獲得的數據將會不斷演變，甚至包括來自 ASCO 本身的數據。因此，您將看到通過我們的試驗或正在進行的 ISR 在各種會議上不斷出現的數據。當然，第三階段將在未來幾年開始宣讀。

Sergei, can we go to the next one, please?

謝爾蓋，我們可以轉到下一個嗎？

Terence Flynn, Morgan Stanley.

特倫斯·弗林，摩根士丹利。

Maybe 2 for me. A follow-up on Opdualag. I know it's still early in the launch, but just wondering what types of patients you're seeing receive the drug? I know your initial focus was going to be on the PD-1 monotherapy setting, but is that pretty consistent? Or are you seeing broader use?

也許對我來說是2個。 Opdualag 的後續行動。我知道現在還處於推出初期，但只是想知道您看到什麼類型的患者正在接受該藥物？我知道您最初的重點是 PD-1 單藥治療，但這是否非常一致？或者您看到更廣泛的用途嗎？

And then in terms of Abecma, what percentage of demand are you able to supply now? And can you help quantify how much additional supply will come on later this year?

那麼就 Abecma 而言，你們現在能夠滿足多少比例的需求？您能否幫助量化今年晚些時候將增加多少供應？

Chris?

克里斯？

Sure. Let me start with Opdualag. So we're very pleased, as David noted, with the -- not only the approval, but the reaction from physicians has been very positive. Based on the early read that we have, and again, it's only a few weeks of data, what we are seeing in the marketplace is entirely aligned with our expectations. So number one the profile is very well received, given the 2x improvement in PFS, the strong trend toward OS, similar safety relative to PD-1 monotherapy. So the excitement that we've seen around the profile is as we hoped and expected for this asset.

當然。讓我從 Opdualag 開始。因此，正如大衛指出的那樣，我們非常高興，不僅得到了批准，而且醫生的反應也非常積極。根據我們所掌握的早期數據，這只是幾週的數據，我們在市場上看到的情況完全符合我們的預期。因此，第一，鑑於 PFS 提高了 2 倍、OS 的強勁趨勢以及相對於 PD-1 單一療法的相似安全性，該概況非常受歡迎。因此，我們在配置文件中看到的令人興奮的內容正如我們對該資產的希望和預期。

Second, what physicians are playing back to us is they see using this product in the segment initially of the market that we had anticipated. Remember, first-line metastatic melanoma is a market that is essentially divided into thirds. 1/3 of patients are getting dual I-O therapy, 1/3 of patients are getting PD-1 monotherapy and the 1/3 are getting targeted therapies, notably BRAF mutants. And so our initial focus had been on the PD-1 monotherapy segment, and that's where physicians have begun to use the product. Now it's possible that over time, that could expand into other segments. But keep in mind that Opdivo/Yervoy has a very strong presence there just given the long-term survival benefit. So we anticipate and what we're hearing right now is that the initial use is going to be in the PD-1 monotherapy as expected.

其次，醫生向我們反饋的是他們看到該產品在我們最初預期的市場領域中使用。請記住，一線轉移性黑色素瘤市場基本上分為三部分。 1/3 的患者正在接受雙重 I-O 治療，1/3 的患者正在接受 PD-1 單藥治療，1/3 的患者正在接受靶向治療，尤其是 BRAF 突變體。因此，我們最初的重點是 PD-1 單一療法領域，這也是醫生開始使用該產品的領域。現在，隨著時間的推移，它可能會擴展到其他領域。但請記住，鑑於長期生存效益，Opdivo/Yervoy 在那裡擁有非常強大的存在。因此，我們預計，我們現在聽到的是，正如預期的那樣，最初的使用將是 PD-1 單一療法。

With respect to Abecma, what I can tell you is that the demand continues to be very strong. We have utilized every manufacturing slot that we have for Abecma over the quarter. Our focus continues to be on building demand to the middle of the year in anticipation of continued strong demand for this asset over time. And remember, this is a space in which we've had a competitive agent enter. And so we've still seen very strong demand for Abecma, which is also in line with expectations. So while I won't give specific guidance as to exactly what that ramp will look like, what I can tell you as our focus continues to be on making sure that we make more slots available for Abecma. We're in line with our expectations on being able to be in a much better position by the middle of the year.

關於 Abecma，我可以告訴您的是，需求仍然非常強勁。本季度我們已經利用了 Abecma 的所有生產空位。我們的重點仍然是在年中之前建立需求，預計隨著時間的推移，對該資產的需求將持續強勁。請記住，這是一個我們已經有競爭性代理商進入的領域。因此，我們仍然看到對 Abecma 的需求非常強勁，這也符合預期。因此，雖然我不會就該坡道的具體情況提供具體指導，但我可以告訴您，因為我們的重點仍然是確保為 Abecma 提供更多空位。我們的預期符合我們的預期，即到今年年中能夠處於更好的位置。

Okay. Can we go to the next one, please?

好的。我們可以轉到下一個嗎？

Dane Leone, Raymond James.

戴恩·萊昂內、雷蒙德·詹姆斯。

Two questions from me, please. Mavacamten, the premise for the acquisition of MyoKardia was obviously, not just Mavacamten but was largely predicated on the opportunity to develop not just in obstructive HCM, but potentially nonobstructive and have passed as well. The question we've been getting a lot since the approval last night and the review of the label, no real surprises in terms of the handholding needed to get a patient on drug and then monitor the patient while they're on drug given the pharmacodynamic and PK properties of mavacamten. But really, the discussion comes down to how in EMBARK, which is your HFpEF study that I think will read out maybe next year, can the dosage and treatment algorithm be modified to make the drug and its properties more accommodative to preserve the ejection fraction in patient population or nonobstructive patient population? And should we expect to have maybe lower doses be viewed as potentially effective in those populations that might resolve some of the handful they needed for the drug?

請問我兩個問題。 Mavacamten，收購 MyoKardia 的前提顯然不僅僅是 Mavacamten，而且很大程度上取決於不僅在阻塞性 HCM 領域的發展機會，而且還有潛在的非阻塞性 HCM 的發展機會，並且已經過去了。自昨晚的批准和標籤審查以來，我們收到了很多問題，考慮到藥效學，在讓患者服用藥物，然後在患者服用藥物時監測患者所需的握持方面，並沒有真正的驚喜和 mavacamten 的 PK 特性。但實際上，討論歸結為 EMBARK（您的 HFpEF 研究，我認為可能會在明年公佈）如何修改劑量和治療算法，使藥物及其特性更加適應，以保持射血分數患者群體還是非阻塞性患者群體？我們是否應該期望較低的劑量可能被視為對那些可能解決該藥物所需的少數問題的人群有效？

And then the second question is actually on Abecma. We will have a readout, I think, coming out the Phase II study. That should be fairly informative. Can you just give us your expectations of what you need to see there to feel confident moving forward and any topic here in the backdrop?

第二個問題實際上是關於 Abecma 的。我認為，我們將在第二階段研究中得到結果。這應該是相當有用的信息。您能否告訴我們您對在那裡看到的內容的期望，以便有信心繼續前進以及背景中的任何主題？

Thank you, Dave. Let me ask Samit to answer both of your questions.

謝謝你，戴夫。讓我請薩米特回答你們的兩個問題。

Yes. Thanks, Dave. The line was getting off, but I think I got the gist of it. So when we think about mavacamten, you very correctly said that now that the drug is approved in obstructive hypertrophic cardiomyopathy, our intent, of course, is based on the data from the MAVERICK Phase II study and the long-term follow-up from there. We are initiating the Phase III program later this year in nonobstructive hypertrophic cardiomyopathy. Now of course, the HFpEF study is a small phase II study, which is a proof-of-concept trial looking at a dose of 2.5 days up to 5 milligrams dose. And that data when we have the proof-of-concept, will then open the door for future indication expansion to HFpEF and at that time we'll be able to have a decision around what dose and how to manage the overall profile in terms of dosing these patients in that indication. So more to come as the data evolves, and we understand it better the application of this medicine in that disease.

是的。謝謝，戴夫。電話快要下線了，但我想我已經明白了要點。因此，當我們想到 mavacamten 時，您說得非常正確，既然該藥物已被批准用於治療梗阻性肥厚性心肌病，我們的意圖當然是基於 MAVERICK II 期研究的數據以及該研究的長期隨訪數據。我們將於今年晚些時候啟動非梗阻性肥厚型心肌病的 III 期項目。當然，現在 HFpEF 研究是一項小型 II 期研究，這是一項概念驗證試驗，著眼於 2.5 天劑量至 5 毫克劑量。當我們獲得概念驗證時，這些數據將為未來適應症擴展到 HFpEF 打開大門，屆時我們將能夠決定使用劑量以及如何管理總體概況：在該適應症中給這些患者給藥。隨著數據的不斷發展，我們會更好地了解這種藥物在該疾病中的應用。

For cendakimab, we have 2 studies that are ongoing. As you know, with a Phase III study in eosinophilic esophagitis. And then, of course, as you said, later this year, we'll see the data from the atopic dermatitis. Now that is the field where we have understood quite well because of the competition that is out there and the data that are out there. So the data that needs to evolve from the Phase II study needs us to be in a place where we can ultimately understand the applicability of this drug and the population that it should be used. So again, let's wait and watch. When the data evolves, we'll be able to discuss that and give more specifics if those data are significant and clinically meaningful to go into Phase III studies.

對於 cendakimab，我們有 2 項正在進行的研究。如您所知，針對嗜酸性粒細胞性食管炎的 III 期研究。當然，正如你所說，今年晚些時候，我們將看到特應性皮炎的數據。現在，由於存在競爭和數據，我們已經對這個領域有了很好的了解。因此，需要從 II 期研究中獲得的數據需要我們能夠最終了解這種藥物的適用性以及應該使用它的人群。那麼，讓我們再次拭目以待。當數據發展時，我們將能夠討論這一點，並提供更多細節，如果這些數據對進入 III 期研究具有重要意義和臨床意義。

Sergei, can we go to the next one? Sergei, can we go to the next question, please? Sergei, can you hear us? Not sure if you can hear us, Sergei. We're here if you can.

謝爾蓋，我們可以進入下一個嗎？謝爾蓋，我們可以進入下一個問題嗎？謝爾蓋，你能聽到我們說話嗎？不確定你是否能聽到我們的聲音，謝爾蓋。如果可以的話，我們就在這裡。

Excuse the interruption. Shall we move on, on the next question?

請原諒打擾。我們繼續討論下一個問題嗎？

Yes, please.

是的，請。

Yes. Go ahead.

是的。前進。

We're out of time at this point. Maybe we should wrap up the call, Giovanni.

我們現在沒時間了。也許我們應該結束通話，喬瓦尼。

Yes. I'm sorry for the last minute issue. Let me just thank you all again for joining our call. And obviously, our teams are available to answer any additional questions you may have. So in concluding, let me just say we're really pleased with the 2 approvals this quarter, the continued progress we've made with our pipeline and our strong commercial performance. That makes me really confident in our ability to continue to execute, we are very well positioned for growth. And I just want to thank our employees for their continued hard work and dedication.

是的。對於最後一刻的問題，我深表歉意。讓我再次感謝大家加入我們的電話會議。顯然，我們的團隊可以回答您可能有的任何其他問題。最後，我只想說，我們對本季度的兩項批准、我們在管道方面取得的持續進展以及強勁的商業表現感到非常滿意。這讓我對我們繼續執行的能力充滿信心，我們已經為增長做好了充分的準備。我只想感謝我們的員工持續的辛勤工作和奉獻精神。

With that, we'll close the call. And again, Tim, Nina and the rest of the team remain available for answering any additional question you may have. Thanks, everyone.

這樣，我們就結束通話了。蒂姆、尼娜和團隊的其他成員仍然可以回答您可能提出的任何其他問題。感謝大家。

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。