施貴寶 (BMY) 2023 Q1 法說會逐字稿

Good day, and welcome to the Bristol-Myers Squibb First Quarter 2023 Earnings Call. (Operator Instructions) And finally, I would like to advise all participants that this call is being recorded. Thank you. I'd now like to welcome Tim Power to begin the conference. Tim, over to you.

美好的一天，歡迎來到 Bristol-Myers Squibb 2023 年第一季度收益電話會議。 （接線員說明）最後，我想通知所有參與者，此通話正在錄音中。謝謝。我現在歡迎 Tim Power 開始會議。蒂姆，交給你了。

Thanks, Kevin. And good morning, everyone. Thanks for joining us this morning for our first quarter 2023 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 Operating Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we posted slides to bms.com that you can follow along with for Giovanni and David's remarks.

謝謝，凱文。大家早上好。感謝您今天早上加入我們的 2023 年第一季度財報電話會議。今天早上，我們的董事會主席兼首席執行官喬瓦尼·卡福里奧 (Giovanni Caforio) 和我一起發表了準備好的講話；和我們的首席財務官 David Elkins。參加今天電話會議的還有我們的首席運營官 Chris Boerner；和 Samit Hirawat，我們的首席醫療官兼全球藥物開發主管。您會注意到，我們將幻燈片發佈到 bms.com，您可以跟隨 Giovanni 和 David 的評論。

But before we get going, I'll read our forward-looking statements. During this call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change.

但在我們開始之前，我會閱讀我們的前瞻性聲明。在此次電話會議中，我們將就公司的未來計劃和前景發表構成前瞻性陳述的陳述。由於各種重要因素，包括公司向美國證券交易委員會提交的文件中討論的因素，實際結果可能與這些前瞻性陳述所表明的結果存在重大差異。這些前瞻性陳述代表我們截至今天的估計，不應作為我們對未來任何日期的估計的依據。我們特別聲明不承擔任何更新前瞻性陳述的義務，即使我們的估計發生變化也是如此。

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

我們還將重點關注我們的非 GAAP 財務指標，這些指標經過調整以排除某些特定項目。 bms.com 提供了某些非 GAAP 財務指標與最具可比性的 GAAP 指標的對賬。有了這個，我會把它交給喬瓦尼。

Thank you, Tim. And good morning, everyone. Before we discuss our first quarter results, I'd like to address the leadership transition plan we announced yesterday. After 23 years at Bristol-Myers Squibb, including the last 8 as CEO, I have decided to retire as CEO effective November 1, 2023, so our family can spend more time together in Europe. I will continue to serve as Executive Chairman for a transition period to be determined by the Board.

謝謝你，蒂姆。大家早上好。在我們討論第一季度業績之前，我想談談我們昨天宣布的領導層交接計劃。在 Bristol-Myers Squibb 工作了 23 年，包括最後 8 年擔任首席執行官後，我決定從 2023 年 11 月 1 日起退休，這樣我們的家人就可以在歐洲度過更多的時光。我將在董事會確定的過渡期內繼續擔任執行主席。

Given the strong foundation achieved to position BMS for growth and success in the future, our strong pipeline and our incredibly deep bench of talent now is a natural time for this transition. That's why I am pleased to share that the Board has selected Chris Boerner, our current Chief Commercialization Officer, as Bristol-Myers Squibb's next CEO as of November 1. Effective yesterday, Chris was named Executive Vice President and Chief Operating Officer. And the Board also intends to appoint him as a member of the Board after the Annual Meeting of Shareholders.

鑑於為 BMS 未來的增長和成功奠定的堅實基礎，我們強大的管道和我們令人難以置信的深厚人才儲備現在是進行這種過渡的自然時機。這就是為什麼我很高興地分享董事會已選擇我們現任首席商務官 Chris Boerner 作為 Bristol-Myers Squibb 的下一任首席執行官，自 11 月 1 日起。從昨天開始，Chris 被任命為執行副總裁兼首席運營官。並且董事會還打算在股東年會之後任命他為董事會成員。

In connection with Chris' appointment, Adam Lenkowsky, SVP, Head of Major Markets, has been named to succeed Chris as Executive Vice President and Chief Commercialization Officer. The Board and I are confident that Chris is the right person to guide BMS through its next chapter of growth. Since joining BMS in 2015, Chris has been instrumental in shaping our strategy and our culture. His passion for science, his commitment to our workforce and his tireless focus on our patients, make him uniquely suited for the role.

與 Chris 的任命相關，高級副總裁兼主要市場主管 Adam Lenkowsky 已被任命接替 Chris 擔任執行副總裁兼首席商務官。董事會和我相信 Chris 是帶領 BMS 度過下一發展篇章的合適人選。自 2015 年加入 BMS 以來，Chris 在塑造我們的戰略和文化方面發揮了重要作用。他對科學的熱情、他對我們員工的承諾以及他對我們患者的不懈關注，使他非常適合這個角色。

Among a long list of accomplishments, Chris has helped guide the evolution of our portfolio over the past several years, notably building our leading presence in immuno-oncology, growing our CV business and launching multiple new medicines. His deep knowledge of our strategy and pipeline and his proven execution across all geographies give us confidence that he is the right leader to drive BMS's vision to be the world's leading biopharma company that transforms patients' lives through science.

在眾多成就中，Chris 在過去幾年幫助指導了我們產品組合的發展，特別是在免疫腫瘤學領域建立了領先地位，發展了我們的 CV 業務並推出了多種新藥。他對我們的戰略和管道的深入了解以及他在所有地區的行之有效的執行力使我們相信他是推動 BMS 成為世界領先的生物製藥公司願景的正確領導者，通過科學改變患者的生活。

Leading BMS has been the highlight of my professional career. And I'm incredibly proud of what our team has accomplished together. I remain enthusiastic about the opportunities ahead and know that we will continue to put patients at the center of everything we do as we drive growth and sustained profitability.

領導 BMS 一直是我職業生涯的亮點。我為我們的團隊共同取得的成就感到無比自豪。我仍然對未來的機會充滿熱情，並且知道在我們推動增長和持續盈利的過程中，我們將繼續把患者放在我們所做的一切的中心。

Our patients-first culture, coupled with our incredibly talented and diverse global workforce will continue to be the engine that drives our success. I look forward to working closely with Chris through the transition. And know, there is a very bright future for Bristol-Myers Squibb with Chris at the helm.

我們以患者為先的文化，加上我們才華橫溢、多元化的全球員工隊伍，將繼續成為推動我們成功的引擎。我期待著在過渡期間與克里斯密切合作。並且知道，在克里斯的掌舵下，百時美施貴寶的前途一片光明。

Now let's turn our attention to our Q1 performance. Starting on Slide 4. As we continue to execute our strategy and accelerate the renewal of our portfolio, I am pleased to share that we had a strong start to the year. I am encouraged by the performance of the products that will drive our future growth.

現在讓我們把注意力轉移到第一季度的表現上。從幻燈片 4 開始。隨著我們繼續執行我們的戰略並加速更新我們的產品組合，我很高興地與大家分享我們今年開局良好。我對將推動我們未來增長的產品的性能感到鼓舞。

During the quarter, our in-line brands and new product portfolio grew 8% or 10% adjusting for foreign exchange. Notably, revenue from our new product portfolio more than doubled compared to 1 year ago, reinforcing our confidence that we expect to roughly double revenue from these products this year.

本季度，我們的在線品牌和新產品組合增長了 8% 或 10%（經匯率調整後）。值得注意的是，與一年前相比，我們新產品組合的收入增加了一倍多，這增強了我們的信心，即我們預計今年這些產品的收入將增加一倍左右。

OPDIVO and Eliquis, both performed very well with strong demand growth, particularly in the U.S. Looking forward, we continue to expect top and bottom line growth driven by our in-line and new product portfolio, more than offsetting the impact of generics. And we are affirming our non-GAAP financial guidance for this year. Along with strong commercial execution in the quarter, we continued to advance our pipeline.

OPDIVO 和 Eliquis 均表現出色，需求增長強勁，尤其是在美國。展望未來，我們繼續預計我們的在線和新產品組合將推動收入和利潤增長，這將抵消仿製藥的影響。我們確認了今年的非 GAAP 財務指導。隨著本季度強勁的商業執行，我們繼續推進我們的產品線。

Turning to our scorecard on Slide 5. As you can see, we delivered meaningful pipeline milestones in Q1. We have a number of catalysts in our pipeline and made important progress expanding our new products, particularly with respect to regulatory achievements.

轉到幻燈片 5 上的記分卡。如您所見，我們在第一季度交付了有意義的管道里程碑。我們有許多催化劑在我們的管道中，並在擴展我們的新產品方面取得了重要進展，特別是在監管成就方面。

Starting with cell therapy, where we further strengthened our growing leadership position. Following the publication of our KarMMa-3 results for triple class-exposed multiple myeloma patients in the New England Journal of Medicine in February, we have now delivered global regulatory filings across the U.S., Europe and Japan for this study. We look forward to the opportunity to offer these transformational products to patients in earlier lines of treatment in multiple markets in the future.

從細胞療法開始，我們進一步鞏固了我們不斷增長的領導地位。繼 2 月份在《新英格蘭醫學雜誌》上發表了我們針對暴露於三類藥物的多發性骨髓瘤患者的 KarMMa-3 結果之後，我們現在已經在美國、歐洲和日本為這項研究提交了全球監管文件。我們期待著有機會在未來向多個市場早期治療的患者提供這些轉化產品。

We also continue to make progress expanding supply for both of our cell therapy products. We recently entered into an agreement for a vector facility in Libertyville, Illinois to further strengthen our supply chain and expand manufacturing capacity. This will allow us to dual source vector supply and transition to newer, higher efficiency manufacturing processes.

我們還繼續在擴大我們兩種細胞治療產品的供應方面取得進展。我們最近就伊利諾伊州利伯蒂維爾的載體設施達成協議，以進一步加強我們的供應鏈並擴大製造能力。這將使我們能夠雙源載體供應並過渡到更新、更高效的製造工藝。

We look forward to supplying more patients with both, Abecma and Breyanzi, as capacity increases over time. Our research teams remain focused on further improving outcomes for patients using cell therapy treatments, including with our exciting CD19 NEX T for severe refractory SLE that is entering the clinic.

隨著產能的增加，我們期待著為更多患者提供 Abecma 和 Breyanzi。我們的研究團隊仍然專注於進一步改善使用細胞療法治療的患者的結果，包括我們令人興奮的 CD19 NEX T 治療即將進入臨床的嚴重難治性 SLE。

Turning now to SOTYKTU. As David will describe, the launch for plaque psoriasis continues to go very well, and we are successfully establishing this product as the oral of choice for moderate to severe patients. And during the quarter, we delivered approval of this medicine for patients in Europe.

現在轉向 SOTYKTU。正如 David 將描述的那樣，斑塊狀銀屑病的上市繼續進展順利，我們正在成功地將此產品確立為中度至重度患者的首選口服藥物。在本季度，我們為歐洲的患者提供了這種藥物的批准。

In addition, we received data from our Phase II trial in Crohn's disease. And while it does not support moving to a Phase III trial at this time, we look forward to seeing data from the high-dose UC trial later this year to evaluate opportunities for this asset in IBD.

此外，我們還收到了克羅恩病 II 期試驗的數據。雖然目前不支持進入 III 期試驗，但我們期待在今年晚些時候看到高劑量 UC 試驗的數據，以評估該資產在 IBD 中的機會。

Meanwhile, we continue to advance SOTYKTU into key expansion opportunities in Phase III studies for both, psoriatic arthritis and Lupus, which, as you know, has a very high unmet medical need.

與此同時，我們繼續將 SOTYKTU 推進到針對銀屑病關節炎和狼瘡的 III 期研究中的關鍵擴展機會，如你所知，這兩種疾病的醫療需求未得到滿足。

And turning now to Camzyos. We recently announced positive CHMP opinion for this medicine. We look forward to bringing this product to European patients soon. Looking at our next set of registrational assets. We have initiated the Phase III study for iberdomide in post-transplant maintenance during the quarter. This study will potentially enable us to demonstrate superiority of iberdomide over revlimid in an early line setting of multiple myeloma.

現在轉向 Camzyos。我們最近宣布了 CHMP 對這種藥物的正面意見。我們期待盡快將該產品帶給歐洲患者。查看我們的下一組註冊資產。本季度，我們啟動了 iberdomide 在移植後維持治療中的 III 期研究。這項研究可能使我們能夠在多發性骨髓瘤的早期線設置中證明伊比度胺優於瑞复美。

And with our partners at Janssen, we are pleased to have now initiated all 3 Phase III trials in the milvexian program. We are excited about the benefits to patients from a potential next-generation antithrombotic that is equal to or better than current factors than a drug in terms of efficacy, but with a better bleeding profile.

我們很高興與我們在 Janssen 的合作夥伴一起啟動了 milvexian 項目的所有 3 期 III 期試驗。我們很高興潛在的下一代抗血栓藥物能給患者帶來好處，這種抗血栓藥物在療效方面等於或優於目前的藥物，但出血情況更好。

As you can see, our progress is strong with multiple exciting pipeline opportunities ahead. Moving to Slide 6, and tying together what this progress means for our new product portfolio. This slide demonstrates that the renewal of our portfolio continues to gain momentum through a combination of strong commercial execution and the achievement of important clinical data and regulatory milestones that further derisk significant revenue opportunities.

正如您所看到的，我們的進展非常強勁，未來有多個令人興奮的管道機會。轉到幻燈片 6，並將這一進展對我們的新產品組合的意義聯繫在一起。這張幻燈片表明，通過強大的商業執行與重要臨床數據和監管里程碑的實現相結合，我們的產品組合的更新繼續獲得動力，這些里程碑進一步降低了重要收入機會的風險。

I am very proud of the accomplishments of our global colleagues as they strive to discover, develop and deliver transformational medicines to patients around the world. Together, we have built the foundation for an even stronger company with a more diversified portfolio of growth products and increased durability across each of our 4 key therapeutic areas.

我為我們全球同事所取得的成就感到非常自豪，因為他們努力發現、開發並為世界各地的患者提供轉化藥物。我們共同為一家更強大的公司奠定了基礎，該公司擁有更多元化的增長產品組合，並在我們的 4 個關鍵治療領域中的每一個領域都提高了耐用性。

Given our growing and rapidly diversifying business and our financial strength and flexibility, I'm excited about the opportunities we have for the rest of 2023 and beyond. I will now turn the call over to David to walk you through our product performance and financial results in more detail. David?

鑑於我們不斷發展和迅速多元化的業務以及我們的財務實力和靈活性，我對我們在 2023 年剩餘時間及以後的機會感到興奮。我現在將把電話轉給大衛，讓他更詳細地介紹我們的產品性能和財務結果。大衛？

Thank you, Giovanni. I'm recognizing this is another busy day for all of you. Thanks again for joining our first quarter earnings call. Turning to Slide 8. Let's discuss our top line performance. Unless otherwise stated, all comparisons are made for the same period in 2022, and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange.

謝謝你，喬瓦尼。我知道今天對你們所有人來說又是忙碌的一天。再次感謝您加入我們的第一季度財報電話會議。轉到幻燈片 8。讓我們討論一下我們的頂級表現。除非另有說明，所有比較均為 2022 年同期，銷售增長率將在基礎基礎上進行討論，其中不包括外彙的影響。

Total company sales in the quarter topped $11.3 billion, driven by strong double-digit sales of our in-line and new product portfolio, offset by (inaudible) loss of exclusivity. Sales in the U.S. grew 4%, driven primarily by volume, while international sales were impacted by the annualization of loss of exclusivity for Revlimid.

本季度公司總銷售額超過 113 億美元，這得益於我們在線產品和新產品組合的強勁兩位數銷售額，但被（聽不清）失去獨家經營權所抵消。美國的銷售額增長了 4%，主要受銷量推動，而國際銷售額則受到 Revlimid 失去獨占權年化影響。

Let's delve deeper into the strong performance of the new product portfolio on Slide 9. As Giovanni mentioned, the new product portfolio generated over $720 million in sales, which more than doubled versus prior year and grew over 11% sequentially.

讓我們在幻燈片 9 上更深入地研究新產品組合的強勁表現。正如 Giovanni 所提到的，新產品組合產生了超過 7.2 億美元的銷售額，比上一年增長了一倍多，環比增長超過 11%。

This strong performance in the quarter was driven primarily by demand for Opdualag, Abecma and Reblozyl, which I will touch on further in a moment, and provides us confidence in the growth potential for our increasingly derisked and diversified new product portfolio.

本季度的強勁表現主要是由對 Opdualag 、 Abecma 和 Rebrozyl 的需求推動的，我將在稍後進一步討論這些需求，並讓我們對我們日益去風險和多樣化的新產品組合的增長潛力充滿信心。

Moving to our solid tumor performance on Slide 10. Global Opdivo sales were strong, growing double digit versus prior year, primarily driven by continued demand for our newly launched and core indications. In the U.S., Opdivo grew 17%, primarily driven by demand in first-line lung, upper GI indications and adjuvant bladder cancer.

轉到我們在幻燈片 10 上的實體瘤表現。全球 Opdivo 銷售額強勁，與上一年相比增長兩位數，這主要是由於對我們新推出的核心適應症的持續需求推動的。在美國，Opdivo 增長了 17%，主要受一線肺癌、上消化道適應症和輔助膀胱癌需求的推動。

Outside the U.S., first quarter revenues increased 18%, primarily driven by demand for recently launched indications and expanded access. The strong execution in the first quarter gives us confidence in the continued growth expected for Opdivo.

在美國以外，第一季度收入增長了 18%，這主要是由於對最近推出的適應症和擴大准入的需求推動的。第一季度的強勁執行讓我們對 Opdivo 的持續增長充滿信心。

Now turning to the robust launch of Opdualag. Sales in the quarter were $117 million, growing double digit versus prior quarter. We are very pleased with the launch of Opdualag in first-line melanoma with market share now over 20%, primarily being sourced from PD-1 monotherapy.

現在轉向 Opdualag 的強勁發布。本季度銷售額為 1.17 億美元，與上一季度相比增長兩位數。我們非常高興在一線黑色素瘤中推出 Opdualag，目前市場份額超過 20%，主要來自 PD-1 單一療法。

Now turning to our expanded cardiovascular portfolio on Slide 11. And starting with Eliquis, which generated over $3.4 billion globally, largely driven by the U.S. In the U.S., sales grew strongly, up 19%, driven primarily by robust demand. Internationally, sales were impacted primarily by generic entries in Canada and the U.K. and pricing measures we mentioned in the past.

現在轉向我們在幻燈片 11 上擴展的心血管產品組合。從 Eliquis 開始，它在全球創造了超過 34 億美元的收入，主要由美國推動。在美國，銷售額增長強勁，增長了 19%，主要受強勁需求的推動。在國際上，銷售主要受到加拿大和英國仿製藥進入以及我們過去提到的定價措施的影響。

Moving now to our first-in-class myosin inhibitor, Camzyos. We continue to be pleased with the progress we are making to bring Camzyos to more patients. Camzyos generated sales of $29 million in the first quarter. Now with approximately 2,700 patients in our hub, of which 1,500 patients on commercial drug at the end of the quarter. We continue to build momentum with considerable growth expected in the quarter-over-quarter.

現在轉向我們一流的肌球蛋白抑製劑 Camzyos。我們繼續對我們在將 Camzyos 帶給更多患者方面取得的進展感到高興。 Camzyos 第一季度的銷售額為 2900 萬美元。現在我們中心大約有 2,700 名患者，其中 1,500 名患者在本季度末使用商業藥物。我們繼續建立勢頭，預計季度環比將有可觀的增長。

We look forward to our upcoming PDUFA date for Valor in June, which will reinforce the strong profile of Camzyos as well as the expected European approval having just received a positive CHMP opinion.

我們期待 6 月即將到來的 Valor PDUFA 日期，這將加強 Camzyos 的強大形像以及預期的歐洲批准，剛剛收到積極的 CHMP 意見。

Now turning to our hematology portfolio on Slide 12. Starting with Revlimid. Global sales in the quarter were approximately $1.8 billion, impacted by generic entry. As we expected, the favorability seen last year reversed in the first quarter. And we continue to expect quarter-to-quarter variability.

現在轉向我們在幻燈片 12 上的血液學產品組合。從 Revlimid 開始。本季度全球銷售額約為 18 億美元，受仿製藥進入的影響。正如我們所料，去年的好感度在第一季度出現逆轉。我們繼續預計季度與季度之間的差異。

Now on to POMALYST, global sales grew 2% versus prior year. In the U.S., longer duration of first-line treatments impacted new prescription volumes. Internationally, revenues grew 12%, driven largely demand for triplet-based regimens as well as some buying patterns.

現在來看 POMALYST，全球銷售額比上一年增長了 2%。在美國，一線治療的持續時間更長會影響新處方量。在國際上，收入增長了 12%，這在很大程度上推動了對基於三胞胎的治療方案以及一些購買模式的需求。

Turning to Reblozyl, which generated revenues of $206 million in the quarter. Sales were strong, up 33%, largely driven by demand. In the U.S., revenues grew 18%, primarily driven by continued total prescription share growth. Internationally, Reblozyl more than doubled as we continue to secure reimbursement in additional countries, including being placed on China's national reimbursement drug list.

轉向 Rebrozyl，它在本季度創造了 2.06 億美元的收入。銷售額強勁增長 33%，主要受需求推動。在美國，收入增長了 18%，主要受總處方份額持續增長的推動。在國際上，隨著我們繼續在更多國家獲得報銷，包括被列入中國的國家報銷藥物清單，Rebrozyl 增加了一倍多。

We are now launched in 25 countries outside the U.S. and expect to launch in additional markets this year. We look forward to presenting the COMMANDS data in an oral presentation at ASCO and EHA to further accelerate the brand by bringing this first-in-class product to first-line ESA-naive MDS patients upon approval.

我們現在在美國以外的 25 個國家/地區推出，並預計今年會在更多市場推出。我們期待在 ASCO 和 EHA 的口頭報告中展示 COMMANDS 數據，通過將這一一流的產品在獲得批准後帶給一線 ESA-naive MDS 患者，進一步加速品牌發展。

Transitioning to our first-in-class and best-in-class cell therapy products of Abecma and Breyanzi. We continue to make progress at expanding capacity, which has enabled robust sales growth driven by strong demand. With sales of $147 million in the quarter, we more than doubled our revenue for Abecma versus prior year and grew 16% sequentially.

過渡到我們一流和一流的 Abecma 和 Breyanzi 細胞治療產品。我們在擴大產能方面繼續取得進展，這使得在強勁需求的推動下實現了強勁的銷售增長。本季度 Abecma 的銷售額為 1.47 億美元，與去年同期相比增長了一倍多，環比增長 16%。

We continue to be pleased with the feedback from physicians on the reproducibility of efficacy and safety in the real world and reliability of our manufacturing capabilities. As Giovanni mentioned, KarMMa-3 and triple-class exposed myeloma patients is now under review in the EU, the U.S. and Japan, and we look forward to bringing Abecma to earlier (inaudible) line patients around the globe.

我們繼續對醫生對現實世界中療效和安全性的可重複性以及我們製造能力的可靠性的反饋感到滿意。正如 Giovanni 提到的，KarMMa-3和三級暴露的骨髓瘤患者目前正在歐盟、美國和日本接受審查，我們期待著將 Abecma 帶給全球更早（聽不清）的一線患者。

Turning to Breyanzi. Sales in the quarter were $71 million, growing 66% versus prior year and 27% sequentially. Sales were driven by demand in second and third-line plus large B-cell lymphoma. With the broadest label in second-line large B-cell lymphoma and differentiated safety profile, feedback from physicians has been very strong, and we are pleased with the strong demand for Breyanzi. We look forward to bringing Breyanzi to earlier line patients in the EU in the coming months, with the recent CHMP positive opinion.

轉向 Breyanzi。本季度銷售額為 7100 萬美元，較上年同期增長 66%，環比增長 27%。銷售是由二線和三線加上大 B 細胞淋巴瘤的需求推動的。憑藉二線大 B 細胞淋巴瘤中最廣泛的標籤和差異化的安全性，醫生的反饋非常強烈，我們對 Breyanzi 的強勁需求感到滿意。我們期待著在未來幾個月內將 Breyanzi 帶給歐盟的早期一線患者，最近 CHMP 給予了積極的評價。

Let's now move to our immunology portfolio on Slide 13. Starting with Zeposia. Global sales in the quarter were $78 million, more than doubling compared to prior year. In the U.S., growth was primarily driven by demand in multiple sclerosis and expanding contribution from ulcerative colitis.

現在讓我們轉到幻燈片 13 上的免疫學產品組合。從 Zeposia 開始。本季度的全球銷售額為 7800 萬美元，比去年同期翻了一番多。在美國，增長主要是由多發性硬化症的需求和潰瘍性結腸炎的貢獻擴大推動的。

Internationally, sales increased primarily to demand in multiple sclerosis and securing reimbursement in additional countries. Lastly, turning to a strong launch of our first-in-class TYK2 inhibitor, SOTYKTU. We're extremely pleased with the launch so far. Just 6 months into the launch, we have over 9,500 script equivalents across bridge and commercial drug. SOTYKTU's share of the oral market is now in the mid-30s, sourcing business from systematic naive patients as well as Otezla and biologic experience patients.

在國際上，銷售額的增長主要是由於多發性硬化症的需求和在其他國家獲得報銷。最後，轉向強勢推出我們一流的 TYK2 抑製劑 SOTYKTU。到目前為止，我們對發布感到非常滿意。推出僅 6 個月後，我們就擁有 9,500 多個跨橋牌和商業藥物的等效腳本。 SOTYKTU 在口腔市場的份額現在處於 30 年代中期，從系統的天真患者以及 Otezla 和生物經驗患者那裡採購業務。

Internationally, we are very pleased with the strong launch performance in Japan and recent approval in Europe and look forward to working with individual countries on securing reimbursement through 2023 and beyond. We are very excited about SOTYKTU with nonrisk-adjusted revenue potential of $4-plus billion based on exciting opportunities ahead and moderate-to-severe psoriasis, cirrhotic arthritis and in lupus.

在國際上，我們對日本的強勁上市表現和最近在歐洲的批准感到非常高興，並期待與各個國家合作，確保 2023 年及以後的報銷。我們對 SOTYKTU 感到非常興奮，基於未來令人興奮的機會以及中度至重度牛皮癬、肝硬化關節炎和狼瘡，非風險調整後的收入潛力超過 40 億美元。

Moving to our first quarter P&L on Slide 14. I will focus my remarks on a few non-key line items just covered -- as I just covered sales performance. In the quarter, as expected, gross margin was impacted by product mix. This was partially offset by favorable foreign exchange and related hedging settlements that will not repeat in the second quarter.

轉到幻燈片 14 上的第一季度損益表。我將把我的評論集中在剛剛提到的幾個非關鍵項目上——就像我剛剛提到的銷售業績一樣。正如預期的那樣，本季度毛利率受到產品組合的影響。這部分被第二季度不會重複的有利外彙和相關對沖結算所抵消。

Operating expenses, excluding acquired in-process R&D remained largely consistent with prior year. MS&A declined 4%, primarily due to timing of spend which we expect to reverse going into the second quarter as we continue to invest in our new launches. Acquired in-process R&D in the quarter was $75 million, which was partially offset by $43 million of licensing income. Overall, first quarter earnings per share was $2.05, growing approximately 5%.

運營費用（不包括收購的在建研發費用）與上一年基本保持一致。 MS&A 下降了 4%，主要是由於我們預計隨著我們繼續投資於新產品，支出時間將在第二季度逆轉。本季度獲得的在製品研發費用為 7500 萬美元，部分被 4300 萬美元的許可收入所抵消。總體而言，第一季度每股收益為 2.05 美元，增長約 5%。

Turning to the balance sheet and capital allocation on Slide 15. Cash flow generation and our balance sheet remains strong. Cash flow from operations in the quarter was approximately $3 billion, with over $9 billion in cash and marketable securities on hand as of March 31.

轉向幻燈片 15 的資產負債表和資本配置。現金流產生和我們的資產負債表依然強勁。本季度運營現金流約為 30 億美元，截至 3 月 31 日，手頭現金和有價證券超過 90 億美元。

As it relates to capital allocation, our priorities remain unchanged, with BD continuing to be our top priority and a focus on balance sheet strength as well as returning capital to shareholders. In the quarter, we repaid $1.6 billion in debt with an additional $2.3 billion maturing this year, and we remain opportunistic about share repurchases in the future with approximately $7 billion remaining in our share repurchase authorization.

由於涉及資本配置，我們的優先事項保持不變，BD 仍然是我們的首要任務，重點關注資產負債表實力以及向股東返還資本。在本季度，我們償還了 16 億美元的債務，還有 23 億美元今年到期，我們對未來的股票回購持機會主義態度，我們的股票回購授權中剩餘約 70 億美元。

Lastly, turning to our 2023 non-GAAP guidance on Slide 16. Based on upon performance to date, we are reaffirming our non-GAAP guidance. We expect 2023 revenues to grow approximately 2% on a reported and constant currency basis, which reflects that our in-line and new product portfolio will more than offset recent LOEs.

最後，轉向我們在幻燈片 16 上的 2023 年非 GAAP 指南。根據迄今為止的表現，我們重申我們的非 GAAP 指南。我們預計 2023 年的收入將在報告和固定貨幣基礎上增長約 2%，這反映出我們的在線和新產品組合將超過近期的 LOE。

Revlimid's sales expectations remain at approximately $6.5 billion, and we will continue to monitor variability from generics and other market dynamics through the year. We remain excited about the promise of our new product portfolio and expect the portfolio to roughly double versus prior year.

Revlimid 的銷售額預期保持在約 65 億美元，我們將在全年繼續監測仿製藥和其他市場動態的變化。我們仍然對我們新產品組合的承諾感到興奮，並預計該產品組合將比去年增加一倍左右。

As we continue to launch these assets around the globe, we expect growth to be more back half weighted as we build momentum during the year. We continue to expect gross margin to be approximately 77%, which reflects a shift in product mix. Accounting for the FX favorability in the first quarter, we expect gross margin for the first half of the year to be approximately 77%.

隨著我們繼續在全球推出這些資產，我們預計隨著我們在這一年建立勢頭，增長的權重將增加一半。我們繼續預計毛利率約為 77%，這反映了產品組合的轉變。考慮到一季度的外匯好感度，我們預計上半年毛利率約為 77%。

Excluding the impact of acquired in-process R&D and our operating expense, guidance remains unchanged and expected decline in the low single-digit range, reflecting efficiency initiatives in MS&A as we continue to up invest in our launch brands. As I mentioned during the results for the quarter, we expect MS&A to increase in the second quarter as we continue to invest in our launches.

不包括收購的在製品研發和我們的運營費用的影響，指引保持不變，預計下降幅度將在低個位數範圍內，這反映了隨著我們繼續加大對推出品牌的投資，MS&A 的效率舉措。正如我在本季度的業績中提到的那樣，隨著我們繼續投資於我們的發布，我們預計 MS&A 將在第二季度增加。

The operating expenses are expected to be approximately $4.2 billion in the second quarter. Our tax guidance of 17% remains unchanged, and we continue to expect earnings per share to be in the range of $7.95 and $8.25.

第二季度的運營費用預計約為42億美元。我們 17% 的稅收指引保持不變，我們繼續預計每股收益將在 7.95 美元和 8.25 美元之間。

Before we move to Q&A, I just want to acknowledge the work of our colleagues across the globe for the relentless commitment and execution to transform this company into a younger and more diversified business. I'll now turn the call back over to Tim and Giovanni for Q&A.

在我們進入問答環節之前，我只想感謝我們全球同事的不懈努力和執行力，將這家公司轉變為一家更年輕、更多元化的企業。我現在將把電話轉回給 Tim 和 Giovanni 進行問答。

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

非常感謝，大衛。凱文，我們可以開始第一個問題了嗎？

[Your first question] comes from the line of Seamus Fernandez from Guggenheim.

[你的第一個問題] 來自古根海姆的 Seamus Fernandez。

So a couple of questions. First on SOTYKTU, just wanted to get a sense of when you feel the free drug dynamics that's out there in the market today is going to catalyze a switch by payers to -- from kind of the loss of rebates of Otezla to then really drive them towards appropriate reimbursement of SOTYKTU.

所以有幾個問題。首先在 SOTYKTU 上，只是想了解一下您何時感覺到當今市場上的免費藥物動態將催化付款人轉變為 - 從 Otezla 的回扣損失到真正推動他們對 SOTYKTU 的適當報銷。

And then just a second question from an R&D perspective. You mentioned lupus as it relates to SOTYKTU. Just hoping to get a little bit more clarity on the discontinuation of the Crohn's disease or the failure of the Crohn's disease trial, as noted in your slide deck. Wanted to just get a better sense of whether that study was stopped for efficacy or if there were any safety signals at all in that study that would be of concern. And perhaps if you could, share the dose that was explored in that study and in the ulcerative colitis study.

然後是從研發角度來看的第二個問題。您提到狼瘡是因為它與 SOTYKTU 相關。只是希望能更清楚地了解克羅恩病的中止或克羅恩病試驗的失敗，如幻燈片中所述。只是想更好地了解該研究是否因療效而停止，或者該研究中是否存在任何值得關注的安全信號。如果可以的話，也許可以分享該研究和潰瘍性結腸炎研究中探索的劑量。

Seamus, maybe I'll start, and then I'll turn it over to Samit. This is Chris. First, the SOTYKTU launch, just as a top line message is going very well. As David mentioned, we're seeing very good uptake and feedback from physicians from a demand standpoint, which is, to your question, probably the most important thing that we can stay focused on in order to free up market access. We're seeing very good progress in the quarter. We had over 9,500 TRx equivalents. We grew new patient enrollments just shy of 40% quarter-over-quarter. So we feel good about those underlying dynamics. And as you allude to, as we continue to build that volume of patients, we'll be able to be in a much better position to negotiate from a payer standpoint.

Seamus，也許我會開始，然後我會把它交給Samit。這是克里斯。首先，SOTYKTU 的發布，正如最重要的消息一樣進展順利。正如大衛所提到的，從需求的角度來看，我們看到醫生的接受度和反饋非常好，對於你的問題，這可能是我們可以繼續關注以釋放市場准入的最重要的事情。我們看到本季度取得了非常好的進展。我們有超過 9,500 個 TRx 等價物。我們的新患者註冊人數環比增長略低於 40%。所以我們對這些潛在的動力感覺良好。正如你提到的，隨著我們繼續增加患者數量，我們將能夠更好地從付款人的角度進行談判。

What I would say is that our focus continues to be on where possible, pulling forward access decisions into this year that would mainly occur in the second half of this year. Right now, most of the commercial drug is coming still from those patients who have open plans and had open plans at launch. But from a baseline standpoint, I would still consider 2024 to be the point at which you'll see substantive changes in market access. But we remain focused on doing everything we can to pull that forward.

我要說的是，我們的重點仍然是在可能的情況下，將訪問決策提前到今年，這主要發生在今年下半年。目前，大部分商業藥物仍來自那些有開放計劃並在上市時有開放計劃的患者。但從基線的角度來看，我仍然認為 2024 年是市場准入發生實質性變化的時間點。但我們仍然專注於盡我們所能推動這一進程。

And thanks, Chris, and thanks, Seamus, for the question. On the Crohn's disease data set. So let me start, first of all, by saying as it was already mentioned by you as well as by David, that SOTYKTU continues to have a broad development program with the approval in psoriasis ongoing Phase III study in psoriatic arthritis as well as SLE, which contributed to that $4 billion forecast that we've always talked about.

感謝 Chris，也感謝 Seamus 提出的問題。在克羅恩病數據集上。因此，首先讓我開始說，正如您和 David 已經提到的那樣，SOTYKTU 繼續擁有廣泛的開發計劃，並批准了銀屑病正在進行的銀屑病關節炎和系統性紅斑狼瘡的 III 期研究，這促成了我們一直在談論的 40 億美元的預測。

On the Crohn's disease side, let's, first of all, remember that as a tick to mechanism of action perspective, currently, there is no proof of concept that is established for this pathway in IBD. As you remember in our Phase II alterative colitis trial, we did not see a signal at that time. And therefore, we had an ongoing study with a higher dose that we will look forward to see the data at the back end of this year. In Crohn's disease, we did not see a signal at this time. So we do not have a proof of concept.

在克羅恩病方面，首先，讓我們記住，作為作用機制觀點的一個標誌，目前，還沒有為 IBD 中的該通路建立概念證明。正如您在我們的 II 期替代性結腸炎試驗中所記得的那樣，我們當時沒有看到任何信號。因此，我們正在進行一項更高劑量的研究，我們期待在今年年底看到數據。在克羅恩病中，我們此時沒有看到信號。所以我們沒有概念證明。

And therefore, we are not going to move forward. It has nothing to do with safety signal. It is as safe as we have already published the data in many of the studies at this time. From the dose perspective, the dose is tested in this particular study. It was 3 milligrams BID and 6 milligrams BID. More to come when we present the data in the future at a medical conference. But at the current time, we are looking forward to look at the data from UC higher dose trial to then have the totality of the data to make decisions on how we move forward.

因此，我們不會繼續前進。與安全信號無關。它與我們目前已經在許多研究中發布的數據一樣安全。從劑量的角度來看，在這個特定的研究中測試了劑量。它是 3 毫克 BID 和 6 毫克 BID。當我們在未來的醫學會議上展示數據時，還會有更多。但目前，我們期待著查看 UC 高劑量試驗的數據，然後利用全部數據來決定我們如何前進。

Your next question comes from the line of Andrew Baum from Citi.

你的下一個問題來自花旗銀行的 Andrew Baum。

A question for Samit and a question for Chris or maybe Adam given the role change. So Samit, you highlighted the (inaudible) program, I assume this is a CAR-T against CD19. I just want to confirm that this is -- contains the (inaudible) switch. And more importantly, there are a limited number of companies in this very exciting space given the (inaudible) last year. How aggressively are you pursuing this in terms of timelines and breadth if you could talk to where you intend to go with this trial, what constraints the FDA put on you given it's a new sell construct? And then how quickly you can expand more generally some sense of the level of excitement in (inaudible) to address refractory or trimming disease.

考慮到角色的變化，有一個問題要問 Samit，還有一個問題要問 Chris 或 Adam。所以 Samit，你強調了（聽不清）程序，我認為這是針對 CD19 的 CAR-T。我只想確認這是 -- 包含（聽不清）開關。更重要的是，鑑於去年（聽不清），這個非常令人興奮的領域中的公司數量有限。如果你能談談你打算在哪裡進行這項試驗，你在時間表和廣度方面追求這一目標的積極性如何，鑑於這是一個新的銷售結構，FDA 對你施加了哪些限制？然後你可以多快地更普遍地擴大某種興奮程度的感覺（聽不清）以解決難治性或修剪疾病。

And then second for Chris and Adam, the impact potentially -- well, the anticipated impact of Medicare price negotiation for Eliquis is likely to be very substantial. I'm curious as to the extent that you can reduce the rebate paid to PBMs without facing punitive action. Obviously, the PBMs tried to speed it from the portfolio some years ago, and they ended up providing access again. So how much leverage do you actually have to mitigate some of that impact on to the PBMs?

然後是克里斯和亞當的第二個，潛在的影響——好吧，醫療保險價格談判對 Eliquis 的預期影響可能非常大。我很好奇您可以在多大程度上減少支付給 PBM 的回扣而不會面臨懲罰性行動。顯然，幾年前 PBM 試圖從產品組合中加速它，但他們最終再次提供了訪問權限。那麼，您實際上有多少槓桿來減輕對 PBM 的一些影響？

Thank you, Andrew, for the question and very appropriately asked in terms of where we are going as well as the platform. So if you recall, nex T CD19, the one that we are using in SLE is the same platform that we've already tested actually. And we presented the data from there last year on our hematological malignancies side. We're using that because it has a shorter turnaround time, and we will be taking that forward in SLE now. From a speed perspective, what I can tell you is that we submitted the IND to the FDA, and we got a safe to proceed within 1.5 to 2 months.

謝謝你，安德魯，就我們的發展方向和平台而言，這個問題非常恰當。因此，如果您還記得，nex T CD19，我們在 SLE 中使用的平台與我們已經實際測試過的平台相同。我們去年在血液惡性腫瘤方面展示了那裡的數據。我們使用它是因為它的周轉時間更短，我們現在將在 SLE 中推進它。從速度的角度來看，我可以告訴你的是，我們向 FDA 提交了 IND，我們在 1.5 到 2 個月內獲得了安全的進展。

So that shows the excitement, not only for us but also the productive dialogue and constructive dialogue we had with the agency of how to move forward. Our initial trial design is to do a Phase I initiation in SLE where the proof of concept from external data does exist already. So we want to go speedily and it's a global trial. So we are not limited to just the U.S. but going to other countries, including the site that generated the data before in Germany, serving as the principal investigator. So we are pretty excited. And based on the data and the emergence of that data, we have the capacity and capability to then expand to other indications, which we have not yet decided, but certainly on track for that.

因此，這不僅顯示了我們的興奮，也顯示了我們與該機構就如何前進進行的富有成效的對話和建設性對話。我們最初的試驗設計是在 SLE 中進行 I 期啟動，其中來自外部數據的概念證明已經存在。所以我們想加快速度，這是一項全球試驗。所以我們不僅僅局限於美國，而是去其他國家，包括之前在德國生成數據的站點，作為主要研究者。所以我們很興奮。基於這些數據和這些數據的出現，我們有能力擴展到其他適應症，我們還沒有決定，但肯定會在這方面走上正軌。

And then with respect to Eliquis, Andrew, I'll take that one. So as you know, we do anticipate that Eliquis will be impacted by government price setting. A couple of things just at a high level to keep in mind. First, the timing of that impact will run up against the timing of our LOE in the U.S. And second, of course, remember, we split the economics on Eliquis with Pfizer.

然後關於 Eliquis，安德魯，我會接受那個。如您所知，我們確實預計 Eliquis 將受到政府定價的影響。要記住一些高層次的事情。首先，這種影響的時間將與我們在美國的 LOE 的時間相吻合。其次，當然，請記住，我們將 Eliquis 的經濟學與輝瑞分開。

That said, we do anticipate that Eliquis will be in the early wave of IRA price setting. With respect to the ability of rebates to address that, as you well know, these are very competitive markets. Within that context, we are always trying to establish a very strong access position with the least impact on the value of our medicines through rebating. And I think we have in our history on Eliquis shown discipline in that regard. As you would expect, we're going to continue to do this in the post IRA world just as we do today.

也就是說，我們確實預計 Eliquis 將處於 IRA 定價的早期浪潮中。關於回扣解決這個問題的能力，眾所周知，這些市場競爭非常激烈。在這種情況下，我們一直在努力建立一個非常強大的准入地位，通過回扣對我們藥品價值的影響最小。我認為我們在 Eliquis 的歷史上在這方面表現出了紀律。正如您所期望的那樣，我們將在後 IRA 時代繼續這樣做，就像我們今天所做的那樣。

At the same time, it's at this point, difficult to speculate on exactly how this is going to play out while many of the details that will be necessary to describe that are still yet to be defined. But what I can commit to is that we're going to continue to negotiate commercial and Medicare rates and formulary position separately, and we're going to be disciplined as we do so.

與此同時，目前很難準確推測這將如何進行，而許多描述所需的細節仍有待確定。但我可以承諾的是，我們將繼續分別就商業和醫療保險費率以及處方集位置進行談判，我們將在這樣做時受到紀律處分。

Comes from the line of Chris Schott of JPMorgan.

來自摩根大通的 Chris Schott 系列。

Just 2 questions here. I guess first on the capital allocation front. I guess given the delevered balance sheet right now -- I guess it's a 2-part question. You've got a lot of launches that are ramping right now. And I guess one of the questions we've been getting is, is there capacity in the organization for Bristol to pursue either near-to-market or on-market drugs at this point? Or is the commercial organization kind of full with what it's doing and the focus should be maybe more on the pipeline side on the BD front? And the second part of this is when I look at -- you've got a $7 billion repo outstanding. Your stocks' trading at 9x earnings, I guess where does repo kind of fit into the mix as you think about capital allocation? And I'll leave it there.

這裡只有2個問題。我想首先是在資本配置方面。我想現在考慮到去槓桿化的資產負債表——我想這是一個由兩部分組成的問題。你現在有很多正在增加的發布。我想我們得到的其中一個問題是，Bristol 組織是否有能力在這一點上追求接近上市或上市的藥物？還是商業組織對它正在做的事情有點滿，重點應該更多地放在 BD 方面的管道方面？第二部分是當我看到 - 你有 70 億美元的未償還回購。你的股票以 9 倍的收益交易，我想在你考慮資本配置時，回購協議在哪些方面適合這種組合？我會把它留在那裡。

Thank you, Chris. This is Giovanni. I'll get started and then I'll ask David to comment. So with respect to your question about our capacity for, first of all, supporting ongoing launches and potentially looking at business development focused on later-stage assets, I don't see commercial capacity as a factor that would constrain our ability to do that. We have fully resourced organizations across all 4 therapeutic areas. In fact, several of the launches are happening across therapeutic area organizations right now. And we've demonstrated our ability to shift resources in support of new launches in new therapeutic areas like dermatology, very effectively in the recent past.

謝謝你，克里斯。這是喬瓦尼。我會開始，然後請大衛發表評論。因此，關於您關於我們能力的問題，首先，支持正在進行的發布並可能著眼於後期資產的業務發展，我認為商業能力不會成為限制我們這樣做能力的因素。我們在所有 4 個治療領域都擁有資源充足的組織。事實上，目前有幾項發射正在跨治療領域組織進行。我們已經證明了我們有能力轉移資源，以支持在皮膚病學等新治療領域推出新產品，這在最近非常有效。

So we definitely, as I've always said, look at areas where we have deep research development and commercial expertise first when we look at BD. And there's obviously -- there's clearly capacity from multiple perspectives to continue to add assets to the portfolio. So when we look at business development, we look at early deals that strengthen the long-term growth profile of the company. Our pipeline is actually really strong right now with respect to that. And we also look at opportunities that have a meaningful shorter-term impact, like we've done with MyoKardia and turning point, which are definitely models that given the right circumstances, we would be happy to continue to support. And I'll ask David to give you a perspective on capital allocation as it pertains to your second question.

因此，正如我一直所說的那樣，我們在研究 BD 時肯定會首先關注我們擁有深入研究開發和商業專業知識的領域。顯然 - 從多個角度來看，顯然有能力繼續向投資組合添加資產。因此，當我們審視業務發展時，我們會著眼於加強公司長期增長前景的早期交易。就此而言，我們的管道現在實際上非常強大。我們還關注具有有意義的短期影響的機會，就像我們對 MyoKardia 和轉折點所做的那樣，在適當的情況下，這些絕對是模型，我們很樂意繼續支持。我會請戴維給你一個關於資本配置的觀點，因為它與你的第二個問題有關。

Chris, thanks for the question. And as you know, business development remains our top priority as far as capital allocation is concerned, as we look to continue to replenish the portfolio and add additional growth opportunities in the second half of the decade. What I'd also say is that we've been committed to delevering and you've seen that we've been able to do that. We're down to 2x debt to EBITDA, which gives us a lot of strategic flexibility from a business development perspective. And also growing the dividend remains a priority for us. We've grown the dividend for the past 14 years. That's a commitment that we have, as you've seen for the past 14 years, we've doing that. And from a share repurchase, you're right. We have $7 billion in share authorization remaining, and we look to be opportunistic as we move forward with that.

克里斯，謝謝你的提問。如您所知，就資本配置而言，業務發展仍然是我們的首要任務，因為我們希望在本世紀下半葉繼續補充投資組合併增加更多增長機會。我還要說的是，我們一直致力於去槓桿化，你已經看到我們已經能夠做到這一點。我們的 EBITDA 債務降至 2 倍，從業務發展的角度來看，這為我們提供了很大的戰略靈活性。此外，增加股息仍然是我們的首要任務。在過去的 14 年裡，我們增加了股息。正如您在過去 14 年中看到的那樣，這是我們的承諾，我們一直在這樣做。從股票回購來看，你是對的。我們還有 70 億美元的股票授權，我們希望在推進這一過程中投機取巧。

Your next question comes from the line of Tim Anderson of Wolfe Research.

你的下一個問題來自 Wolfe Research 的 Tim Anderson。

This is Adam on for Tim. So on Camzyos, it seems like the uptake has been a little slow so far. Is REMS major gating factor? Can you comment on what percent of target prescriber market REMS certified at this point? And should we expect -- and how should we expect this to progress throughout the year? Also, at what point will the majority of targeted doctors be around certified? Is it too optimistic to think that, that could be by year-end 2023?

這是蒂姆的亞當。所以在 Camzyos 上，到目前為止，吸收似乎有點慢。 REMS 是主要的門控因素嗎？您能否評論一下目前通過 REMS 認證的目標處方藥市場的百分比？我們應該期待——我們應該如何期待這在全年取得進展？此外，大多數目標醫生將在什麼時候獲得認證？認為到 2023 年底就可以實現，是不是太樂觀了？

Sure. Let me take that, Adam. So first, we're pleased with the continued rollout of Camzyos. To your question about REM-certified physicians, we actually saw about a 25% increase in HCPs who were REM-certified in the quarter. We're now at approximately 3,250. The vast majority of those are coming from our top-tier accounts. We continue to drive utilization in those top-tier accounts. And so remember, we were targeting roughly 500 accounts at launch. If you look at the highest volume of those 500 accounts, we have utilization now in excess of 90% in those accounts. We're continuing to add additional utilization in those accounts every week. And then in the quarter, we expanded the team -- the Eliquis cardiovascular team to begin targeting accounts beyond those initial 500.

當然。讓我接受，亞當。首先，我們對 Camzyos 的持續推出感到滿意。關於您關於 REM 認證醫生的問題，我們實際上看到本季度獲得 REM 認證的 HCP 增加了約 25%。我們現在大約有 3,250 人。其中絕大多數來自我們的頂級客戶。我們繼續推動這些頂級賬戶的利用率。請記住，我們在發佈時的目標是大約 500 個帳戶。如果您查看這 500 個賬戶中數量最多的賬戶，我們現在在這些賬戶中的利用率超過 90%。我們每週都會繼續在這些帳戶中增加額外的利用率。然後在本季度，我們擴大了團隊——Eliquis 心血管團隊，開始瞄準最初 500 個以外的客戶。

The purpose being to continue to not only expand utilization outside of those institutions, but also importantly, to increase referrals into those institutions, and we've seen a nice uptake in patients coming in for enrollment. In fact, we saw about a 50% increase in the first quarter relative to the fourth quarter. So as we step back and look at it, the rollout of Camzyos continues to perform well. We do anticipate that the majority of use will continue to be in those top-tier accounts, as you allude to. We're seeing a nice uptake, and we'll continue to see uptake through the course of the year. And I would expect that Camzyos' growth profile will continue to accelerate as we get further into the year as well.

目的不僅是繼續擴大這些機構以外的利用，而且重要的是，增加對這些機構的轉診，我們已經看到入組患者的接受度很高。事實上，我們看到第一季度相對於第四季度增長了約 50%。因此，當我們退後一步來看時，Camzyos 的推出繼續表現良好。正如您提到的那樣，我們確實預計大部分使用將繼續在這些頂級帳戶中進行。我們看到了很好的吸收，並且我們將在這一年中繼續看到吸收。而且我預計，隨著我們進入今年，Camzyos 的增長狀況將繼續加速。

Your next question comes from the line of Steve Scala of Cowen.

你的下一個問題來自 Cowen 的 Steve Scala。

I have 2 questions. First, can you describe the progression of Revlimid in 2023 on a quarter-by-quarter basis? And what are the primary drivers of that? So specifically, was Q1 likely the high quarter in 2023, or will it be more volatile?

我有兩個問題。首先，您能否描述一下 Revlimid 在 2023 年每個季度的進展情況？其主要驅動因素是什麼？那麼具體來說，第一季度可能是 2023 年的高季度，還是會更加波動？

And then secondly, if I may, Giovanni, given your experience tenure now transition, any thoughts on the outlook for the industry over the next decade on pricing, IP, ability to be continually innovative would be helpful. Is the industry just headed for death by a thousand cuts, or will the future be more like the past? And we know there's a huge unmet need. So we're more looking for what's likely to happen.

其次，喬瓦尼，如果可以的話，鑑於你現在的任期過渡，任何關於未來十年行業前景的定價、知識產權、持續創新能力的想法都會有所幫助。該行業是否正走向千刀萬剮的死亡之路，還是未來會更像過去？我們知道有一個巨大的未滿足的需求。所以我們更多地尋找可能發生的事情。

Thank you, Steve. Let me -- thanks for your question. This is Giovanni. I'll answer briefly. The second question, obviously, be happy to continue the dialogue and then, I'll ask David to give you the answer on Revlimid. Listen, I think as I step back and think about where the industry is, the most important point is that science is progressing faster than ever. And quite frankly, as I've stepped back and really thought about the last few years, the immuno-oncology impact on cancer care has been extraordinary. I personally believe that cell therapy will be as impactful going forward. Earlier today in the call, we discussed what's happening in terms of hematologic malignancies but also the potential to expand 2 of the immune diseases and 1-day solid tumors, I think that will be a modality that will have a really big impact in the industry.

謝謝你，史蒂夫。讓我——謝謝你的問題。這是喬瓦尼。我會簡短地回答。第二個問題，顯然，很高興繼續對話，然後我會請大衛給你關於 Revlimid 的答案。聽著，當我退後一步思考這個行業的位置時，最重要的一點是科學的進步比以往任何時候都快。坦率地說，當我退後一步並認真思考過去幾年時，免疫腫瘤學對癌症治療的影響非同尋常。我個人認為，細胞療法將在未來發揮同樣的影響力。在今天早些時候的電話會議中，我們討論了血液惡性腫瘤方面正在發生的事情，以及擴大 2 種免疫疾病和 1 天實體瘤的潛力，我認為這將是一種對該行業產生真正重大影響的方式.

I think we're very well positioned as the leader in that sector. So I personally think that science will continue to be creating exciting opportunities. I also believe that when I look at what is happening at BMS, we are now beginning to see the impact of the data, technology, the digital transformation we've invested in for many years is beginning to have in terms of fundamentally accelerating R&D efforts and productivity, I think that's going to be really important for us to bring the full pipeline to bear. You are right that there are meaningful headwinds from an access and pricing perspective everywhere around the world. And I think that just raises the bar for innovation. But I do believe that companies like BMS will continue to be successful just because of the strength of science. David?

我認為我們在該領域處於領先地位。所以我個人認為科學將繼續創造令人興奮的機會。我還相信，當我審視 BMS 正在發生的事情時，我們現在開始看到數據、技術的影響，我們多年來投資的數字化轉型開始在從根本上加速研發工作方面產生影響和生產力，我認為這對我們來說非常重要，讓整個管道發揮作用。你是對的，從訪問和定價的角度來看，世界各地都存在重大的不利因素。我認為這只是提高了創新的門檻。但我確實相信像 BMS 這樣的公司會因為科學的力量而繼續取得成功。大衛？

Steve, thanks for your question on Revlimid. Just a couple of things. One, just reaffirming the full year guidance of $6.5 billion on Revlimid. As far as quarter-to-quarter, you should expect to see continued variability, because we really don't control how the generics bring product to the marketplace. But as you're thinking about just a couple of points for you to consider. One, remember, we had a better Q4 than we're anticipating. So we think some of that has come out in Q1.

史蒂夫，感謝您對 Revlimid 的提問。只是幾件事。第一，只是重申 Revlimid 的全年指導價值 65 億美元。就季度到季度而言，您應該期望看到持續的變化，因為我們真的無法控制仿製藥如何將產品推向市場。但是，正如您所考慮的那樣，您只需要考慮幾點。第一，請記住，我們的第四季度比我們預期的要好。所以我們認為其中一些已經在第一季度出現。

Also, the other thing I'd remind you of, Q1 of last year is, first, we saw generic entry really didn't come in until the February timeframe in Europe, and in the U.S., it was March. So Q1 of last year is our toughest comp. But look, I think the main takeaway is here is we're still thinking about this as $6.5 billion for the full year. We continue to expect that we're going to have variability, and we'll update you as the year progresses on that.

另外，我要提醒你的另一件事是，去年第一季度，首先，我們看到仿製藥進入歐洲直到 2 月的時間框架才真正進入，而在美國，則是 3 月。所以去年第一季度是我們最艱難的競爭。但是看，我認為主要的收穫是我們仍在考慮全年 65 億美元。我們繼續期望我們會有變化，我們會隨著時間的推移向您更新。

Your next question comes from the line of Chris Shibutani from Goldman Sachs.

你的下一個問題來自高盛的 Chris Shibutani。

Giovanni, appreciate your tenure. Chris, congratulations, and Adam as well. My question's in terms of, as you think about what you bring to bear from your commercial experience, Chris, do you think that on the forward that Bristol and the industry has the right structure, strategy and footprint in terms of thinking about commercializing in the U.S. as well as in Europe? And then secondly, related to that, if I could also ask about the immunology portfolio overall. Good initial traction with SOTYKTU. It's an area where the company historically had a bigger presence seems to be re-emerging. How are you thinking about whether you have critical mass in that realm? And how intrigued are you about focusing potential business development in that area on the commercial or in the R&D side?

喬瓦尼，感謝你的任期。克里斯，祝賀你，還有亞當。我的問題是，當你考慮你的商業經驗帶來的影響時，克里斯，你認為布里斯托爾和該行業在考慮商業化方面擁有正確的結構、戰略和足跡嗎？美國和歐洲？其次，與此相關的是，我是否還可以詢問整體免疫學組合。 SOTYKTU 具有良好的初始牽引力。這是一個公司在歷史上擁有更大影響力的領域，似乎正在重新出現。您如何考慮您是否在該領域擁有臨界質量？您對該領域的潛在業務發展集中在商業或研發方面有多感興趣？

Thanks for the question. I'll obviously take that. So first, let me just say, in terms of the transition, I'm absolutely thrilled with the opportunity. The past 8 years have been really the highlight of my career here at BMS, and I'm certainly looking forward to taking on the broader opportunity and continuing to work with the absolutely exceptional talent that we have at the company across all aspects of the company. With respect to the structure and how that's evolving, first, I think that if you look at BMS historically, we have always evolved how we're organized, where we place our resources, how we allocate those resources across channels to be aligned with, a, the portfolio we have, and b, the environment that we're operating in.

謝謝你的問題。我顯然會接受的。所以首先，我只想說，就過渡而言，我對這個機會感到非常興奮。過去 8 年確實是我在 BMS 職業生涯的亮點，我當然期待著接受更廣泛的機會，並繼續與我們在公司各個方面擁有的絕對傑出人才一起工作.關於結構以及它是如何演變的，首先，我認為如果你從歷史上看 BMS，我們一直在演變我們的組織方式、我們放置資源的位置、我們如何跨渠道分配這些資源以與之保持一致， a，我們擁有的投資組合，b，我們運營的環境。

And I think that just at a macro level, that's how I would think about how we're going to continue to operate going forward. As Giovanni just alluded to in the previous question, there are obviously puts and takes in the industry. There's a lot to be excited about. There are also some headwinds. And so as we constantly are looking at the commercial model, we're staying focused on aligning that model to the world we live in. Clearly, digital is going to continue to play a much bigger role. We do believe that there will continue to be personal interactions required with key stakeholders. Health care is, by its nature, a personal interaction. The size and focus and orientation of those personal interactions will undoubtedly evolve. And we're going to continue to stay ahead of all of those trends.

而且我認為只是在宏觀層面上，這就是我對我們將如何繼續運營的思考方式。正如 Giovanni 在上一個問題中提到的那樣，這個行業顯然有看跌期權和看跌期權。有很多值得興奮的事情。還有一些不利因素。因此，當我們不斷審視商業模式時，我們將繼續專注於使該模式與我們生活的世界保持一致。顯然，數字將繼續發揮更大的作用。我們確實相信，將繼續需要與主要利益相關者進行個人互動。就其本質而言，醫療保健是一種個人互動。這些個人互動的規模、重點和方向無疑會發生變化。我們將繼續保持領先於所有這些趨勢。

As -- with respect to immunology specifically, that's an incredibly exciting area for us. As you've alluded to, we have had a presence in that space with ORENCIA. We're very excited about both, Zeposia and the launch with SOTYKTU. And as we've talked about on this call, there's considerable opportunity to continue to grow that presence over time. That's required already for us to build additional capabilities in, for example, market access, which is a different dynamic in immunology versus oncology. I mean we're going to continue to make sure that we're allocating resources to ensure that, that particular portfolio is very successful commercially, both in the U.S. and ex U.S.

至於——特別是關於免疫學，這對我們來說是一個令人難以置信的令人興奮的領域。正如您所提到的，我們已經與 ORENCIA 一起出現在那個領域。我們對 Zeposia 和 SOTYKTU 的發布感到非常興奮。正如我們在本次電話會議上談到的那樣，隨著時間的推移，有相當大的機會繼續擴大這種影響力。這已經要求我們在市場准入等方面建立額外的能力，這在免疫學和腫瘤學中是不同的動態。我的意思是，我們將繼續確保我們正在分配資源，以確保該特定投資組合在美國和美國以外的地區都在商業上非常成功。

Your next question comes from the line of Geoff Meacham of Bank of America.

你的下一個問題來自美國銀行的 Geoff Meacham。

We also wanted to start by saying, best wishes, Giovanni, you'll be missed, and congrats to both, Chris and Adam. On the life cycle management for Opdivo, Opdualag has seen pretty strong demand. Can you talk about where you think you could go beyond lung. I wasn't sure what was supported by the mechanism or any newer data that you have? And then secondly, on subcutaneous Opdivo, maybe talk about where this falls and your priorities across the pipeline? And then what your expectations are for additional IP?

我們還想首先說，祝你好運，Giovanni，我們會想念你，並祝賀 Chris 和 Adam。在 Opdivo 的生命週期管理方面，Opdualag 看到了相當強勁的需求。你能談談你認為你可以超越肺部的地方嗎？我不確定該機製或您擁有的任何更新數據支持什麼？其次，關於皮下注射 Opdivo，也許可以談談它的落腳點以及您在整個管道中的優先事項？那麼您對額外 IP 的期望是什麼？

Sure. Thank you, Geoff, for the question. For Opdualag, let's, first of all, review, there is a large program already underway. Number one, already approved in the first-line metastatic melanoma. Number two, adjuvant melanoma. We are looking forward to the readout of that trial. Number three, the registration trial ongoing in colorectal cancer and MSS stable patient population, again, looking forward to that readout in the coming year or two. Then beyond that, the proof-of-concept studies that are already ongoing. In non-small cell lung cancer, we are conducting a randomized Phase II study to generate the data and also, to look at the progression-free survival as we compare combination of Opdualag with chemotherapy, comparing it to a single agent I-O plus chemotherapy.

當然。謝謝杰夫提出的問題。對於Opdualag，首先讓我們回顧一下，已經有一個大型項目在進行中。第一，已經批准用於一線轉移性黑色素瘤。第二，輔助黑色素瘤。我們期待著該試驗的讀出。第三，在結直腸癌和 MSS 穩定患者人群中正在進行的註冊試驗，再次期待在未來一兩年內的讀數。除此之外，概念驗證研究已經在進行中。在非小細胞肺癌中，我們正在進行一項隨機的 II 期研究以生成數據，並在我們比較 Opdualag 與化療的組合時查看無進展生存期，將其與單一藥物 I-O 加化療進行比較。

So that will be a very important data set to define our path forward in non-small cell lung cancer. In addition to that, we have the programs ongoing in hepatocellular carcinoma as well. And there's a large investigator-initiated program that is going in parallel to see where the signals might be generated as we look forward. From the subcu Opdivo perspective, certainly excited about that in terms of looking at the readout. You know that the registration trial was ongoing in renal cell cancer. And as is the general practice, the application, if it is successful and if it is approved, then the application would be good for all other indications where nivolumab today uses a single agent. From a commercial perspective, maybe, Chris, do you want to comment on that?

因此，這將是一個非常重要的數據集，可以定義我們在非小細胞肺癌方面的前進道路。除此之外，我們還有正在進行的肝細胞癌項目。並且有一個由調查人員發起的大型項目正在並行進行，以查看我們期待的信號可能在哪裡產生。從 subcu Opdivo 的角度來看，在查看讀數方面肯定會感到興奮。你知道腎細胞癌的註冊試驗正在進行中。與一般做法一樣，該應用程序如果成功並獲得批准，那麼該應用程序將適用於今天 nivolumab 使用單一藥物的所有其他適應症。從商業角度來看，也許，克里斯，你想對此發表評論嗎？

Sure. I think Samit's covered most of it. But I would say that we've always thought about subcu as something that is mainly focused on pushing the science forward and being able to support the needs of our customers. And in that regard, we see subcu potentially playing an important role in those accounts where [chair] time is at a premium. It could be particularly important in, for example, an adjuvant setting where physicians may not need to have a more involved conversation with patients when they come in and there's a desire to get patients in and out and back on with their lives over an extended period of time. And so that's where we see subcu playing a particularly important role. I know there's been a lot of questions around the impacts of this under IRA. I think it's still unclear and too early to talk about that. But the way we think about subcu is very much in how do we improve the profile of this modality for customers and for patients.

當然。我認為 Samit 已經涵蓋了大部分內容。但我要說的是，我們一直將 subcu 視為主要專注於推動科學進步並能夠支持客戶需求的東西。在這方面，我們認為 subcu 可能會在 [主席] 時間非常寶貴的那些賬戶中發揮重要作用。例如，在輔助環境中，這可能特別重要，在這種環境中，醫生可能不需要在患者進來時與他們進行更深入的交談，並且希望讓患者在很長一段時間內進出並重新開始他們的生活的時間。這就是我們看到 subcu 發揮特別重要作用的地方。我知道有很多關於 IRA 下的影響的問題。我認為現在談論這個還不清楚，也為時過早。但我們對 subcu 的看法很大程度上取決於我們如何為客戶和患者改善這種模式的形象。

Your next question comes from the line of Terence Flynn of Morgan Stanley.

你的下一個問題來自摩根士丹利的特倫斯弗林。

My congrats to Chris as well and best to Giovanni in your retirement. Maybe a two-part one. Just wondering on Reblozyl in first line, I know we'll see the COMMANDS data at ASCO, but just maybe you could speak to your confidence in a broad first-line label. And then given the recent CARTITUDE-4 data for a competitive product, just wondering how you think about the competitive positioning here of Abecma once we see supply normalized in the CAR T space for myeloma.

我也祝賀 Chris，並祝賀 Giovanni 退休。也許是兩部分的。只是想知道一線的 Rebrozyl，我知道我們會在 ASCO 上看到命令數據，但也許你可以說出你對廣泛的一線標籤的信心。然後考慮到最近的競爭產品 CARTITUDE-4 數據，只是想知道一旦我們看到骨髓瘤 CAR T 空間的供應正常化，您如何看待 Abecma 的競爭定位。

So thanks, Terence, for the questions. For Reblozyl command, let's again look at Reblozyl Command study was conducted in an all-comer patient population. So both RS-positive and RS-negative. Certainly, you'll see the data being presented at ASCO, and we can have a longer discussion at that time. But overall, the studies that are positive, we met the primary endpoint. We met the secondary end points as well. Very important to note that in general, the longevity of that transfusion independence is a very critical factor that one should observe during the presentation, because that's what matters in the real world and to the patient, how long they can stay away from transfusion. So overall, we are actually quite excited about the data. And of course, regulatory interactions will continue.

謝謝特倫斯提出的問題。對於 Rebrozyl 命令，讓我們再次看一下 Rebrozyl 命令研究是在所有患者人群中進行的。所以 RS 陽性和 RS 陰性。當然，您會在 ASCO 上看到數據，屆時我們可以進行更長時間的討論。但總的來說，積極的研究，我們達到了主要終點。我們也遇到了次要終點。非常重要的是要注意，一般來說，輸血獨立性的長壽是一個非常關鍵的因素，人們應該在演示過程中觀察到這一點，因為這對現實世界和患者來說很重要，他們可以遠離輸血多久。所以總的來說，我們實際上對這些數據感到非常興奮。當然，監管互動將繼續。

Just from a commercial standpoint on COMMANDS and then we'll talk about the competitive dynamics you mentioned. I think it's important to recognize that, that COMMANDS is a very important opportunity commercially, both in the U.S. and potentially outside of the U.S. It roughly doubles the size of the MDS opportunity. And as Samit just alluded to, it's important to keep in mind the significant unmet need in the space. Chronic anemia and transfusion dependence for lower-risk MDS patients across the board is a significant challenge. Yet there's a significant risk of death at roughly 50% greater compared to transfusion-independent patients. And while ESAs are the dominant first-line option for these patients, we need to remember that efficacy and duration of response is very limited.

僅從 COMMANDS 的商業角度來看，然後我們將討論您提到的競爭動態。我認為重要的是要認識到，無論是在美國還是在美國以外，COMMANDS 都是一個非常重要的商業機會。它大約是 MDS 機會的兩倍。正如 Samit 剛才提到的那樣，重要的是要牢記該領域未滿足的重大需求。低危 MDS 患者的慢性貧血和輸血依賴是一項重大挑戰。然而，與不依賴輸血的患者相比，死亡風險要高出大約 50%。雖然 ESAs 是這些患者的主要一線選擇，但我們需要記住，療效和反應持續時間非常有限。

So we view this as a potentially very attractive commercial opportunity. As it relates to the competitive dynamics with Abecma, obviously, data in this space continues to evolve very quickly, both with respect to the CAR T 2 data and our own KarMMa-3 data. As we think about it, first and foremost, we need to see the data. We need to see the details of these data. But as we've consistently said, as the data progresses with CAR Ts in hematology, we're seeing real patient benefit. And I think that's very exciting for patients. Across these products, we continue to see the importance of BCMA targeting. And most importantly, as we said from the very beginning, we see the room for multiple competitors to operate in this space, and that continues to be our view. It is, however, important to keep in mind that KarMMa-3 and CARTITUDE-4 have 2 different patient populations.

所以我們認為這是一個潛在的非常有吸引力的商業機會。由於它與 Abecma 的競爭動態相關，顯然，這個領域的數據繼續快速發展，無論是關於 CAR T 2 數據還是我們自己的 KarMMa-3 數據。考慮到這一點，首先也是最重要的是，我們需要查看數據。我們需要查看這些數據的詳細信息。但正如我們一直所說的那樣，隨著 CAR T 在血液學方面的數據取得進展，我們看到了真正的患者受益。我認為這對患者來說非常令人興奮。在這些產品中，我們繼續看到 BCMA 靶向的重要性。最重要的是，正如我們從一開始就說過的那樣，我們看到了多個競爭對手在這個領域開展業務的空間，並且這仍然是我們的觀點。然而，重要的是要記住 KarMMa-3 和 CARTITUDE-4 有 2 個不同的患者群體。

So it's difficult to compare these 2 studies. In KarMMa-3, we intended to design a study that reflects the patients that physicians see. We enrolled patients who are more difficult to treat. The vast majority of them are data refractory. All of them are triple-class exposed. And so these are patients who you can think about being more third- to fifth-line patients. So I think it's going to be really critical that we see the full data set and then, we take that data set into consideration with respect to how these products are performing in the real world. And what we consistently hear from customers is they want to see efficacy and safety that aligns in the real world to what they saw in the clinical studies, and they want to see manufacturing reliability. And we think those are all going to be important to keep an eye on as the full data sets get presented.

所以很難比較這兩項研究。在 KarMMa-3 中，我們打算設計一項反映醫生所見患者的研究。我們招募了更難治療的患者。其中絕大多數是數據難處理的。全部都是三級暴露。因此，您可以將這些患者視為更多的三線至五線患者。所以我認為我們看到完整的數據集非常重要，然後我們將這些數據集考慮到這些產品在現實世界中的表現。我們一直從客戶那裡聽到的是，他們希望看到現實世界中的療效和安全性與他們在臨床研究中看到的一致，並且他們希望看到製造可靠性。我們認為，隨著完整數據集的呈現，這些都將很重要，需要密切關注。

Your next question comes from the line of Carter Gould of Barclays.

你的下一個問題來自巴克萊銀行的卡特古爾德。

Giovanni, best of luck in the future. I guess 2 for me. First on, I'd love to hear how you guys are thinking about sort of the frontline opportunity in Hodgkin's. Obviously, we're going to see the late breaker of nivolumab versus brentuximab at ASCO, but could that NCI data under certain circumstances be registrational? How you're thinking about that? And then, Samit, to whatever said I can get you to comment on sort of the next-generation SOTYKTU asset, and how you think about differentiation there versus SOTYKTU?

喬瓦尼，祝你未來好運。我想 2 對我來說。首先，我很想听聽你們是如何考慮霍奇金的前線機會的。顯然，我們將在 ASCO 上看到 nivolumab 與 brentuximab 的較晚突破，但在某些情況下 NCI 數據是否可以註冊？你是怎麼想的？然後，薩米特，無論我說什麼，我都能讓你對下一代 SOTYKTU 資產發表評論，以及你如何看待那裡與 SOTYKTU 的區別？

Sure. Thank you, Carter. Look, on the first question around the Hodgkin's lymphoma data, we are aware of the data, of course, as you know, that this was a cooperative group that conducted this study. So it is not sponsored by BMS. But as we look at the data and as they are supportive, we will certainly, as appropriate, engage the health authorities, but certainly very excited to see that the data has come out positive. That could be really beneficial for patients in the future.

當然。謝謝你，卡特。看，關於關於霍奇金淋巴瘤數據的第一個問題，我們知道數據，當然，正如你所知，這是一個合作小組進行了這項研究。所以它不是由 BMS 贊助的。但是，當我們查看數據並且它們具有支持性時，我們當然會酌情與衛生當局接觸，但肯定會非常高興地看到數據是積極的。這可能對未來的患者真正有益。

In terms of the next-generation TYK2 inhibitor, we are in the early stages. We've just initiated our program, a Phase I study and then looking into psoriasis right now. But as we evolve with the data, we have our deep expertise and deep knowledge of the TYK2 pathway as well as psoriasis. So we'll be able to contrast and compare and define the clinical development plan as we go to the future for additional indications. And look for differentiation as well. So more to come. But at this time, we are just beginning those steps.

就下一代 TYK2 抑製劑而言，我們處於早期階段。我們剛剛啟動了我們的項目，即第一階段研究，然後立即研究牛皮癬。但隨著我們隨著數據的發展而發展，我們對 TYK2 通路和銀屑病擁有深厚的專業知識和深入的了解。因此，當我們走向未來以獲得更多適應症時，我們將能夠對比、比較和定義臨床開發計劃。並尋找差異化。所以還有更多。但此時，我們才剛剛開始這些步驟。

Your next question comes from the line of Robyn Karnauskas from Truist Securities.

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

Just a couple on Opdualag. It looks like your growth rate -- your market share quarter-over-quarter were slowing a little bit. Can you just give some dynamics of how you think -- how much more penetration you can get into the melanoma space? And then second, just going back to the lung readout this year. A lot of other companies are focused on different IO-IO combos. What is your thought on the bar for success that you want to see? And then how you think it will shake up mechanistically compared to other IO compounds that other companies are developing?

Opdualag 上只有一對夫婦。看起來你的增長率——你的市場份額環比有所放緩。你能不能給出一些你的想法的動態 - 你可以進入黑色素瘤領域的滲透率是多少？其次，回到今年的肺讀數。許多其他公司都專注於不同的 IO-IO 組合。您對希望看到的成功標準有何看法？那麼，與其他公司正在開發的其他 IO 化合物相比，您認為它在機械上會發生怎樣的變化？

So maybe I'll start, and then I'll turn it over to Samit. Look, we're very pleased with the continued uptake of Opdualag. As I think was referenced earlier, the shares are now over 20%. Keep in mind, we're also seeing some use in the second line plus setting. There are a few underlying dynamics that we're particularly happy about. First, we're seeing roughly 65% of the utilization coming from PD-1 monotherapy. And remember, that is the lowest [hanging] fruit for continued growth of this product. And we see monotherapy is still in that 15% to 20% range in terms of use in the first-line setting. So there's still considerable opportunity to grow there. We are seeing some physicians sourced from OPDIVO, YERVOY. Those are mainly physicians who have some concerns about YERVOY toxicity, but we would envision that, that will continue as well.

所以也許我會開始，然後我會把它交給 Samit。看，我們對 Opdualag 的持續採用感到非常高興。正如我之前提到的那樣，這些股份現在已超過 20%。請記住，我們還在第二行加上設置中看到了一些用途。有一些我們特別高興的潛在動力。首先，我們看到大約 65% 的利用率來自 PD-1 單一療法。請記住，這是該產品持續增長的最低 [懸垂] 果實。我們看到單藥療法在一線環境中的使用率仍處於 15% 至 20% 的範圍內。所以那裡仍然有相當大的發展機會。我們看到一些來自 OPDIVO、YERVOY 的醫生。這些主要是醫生，他們對 YERVOY 的毒性有一些擔憂，但我們預計這種情況也會繼續下去。

So that's an additional opportunity to grow this business. The other thing I would note is that during the first quarter, we actually saw an NCCN update. I mean that update is really important, because what it did was it removed [BRAF NEC] inhibitors as a preferred treatment in the first-line setting. And so now when you look at preferred treatment options in first-line melanoma, they are all dual IO, either OPDIVO, YERVOY or Opdualag. And I think that's a really important recognition on the importance of dual I-O therapy targeted in that first-line setting. Opdualag is going to continue to play a really important opportunity there. And then beyond melanoma, clearly, Samit has already articulated some of the opportunities there. Samit?

所以這是發展這項業務的額外機會。我要注意的另一件事是，在第一季度，我們實際上看到了 NCCN 更新。我的意思是更新真的很重要，因為它所做的是刪除了 [BRAF NEC] 抑製劑作為一線治療的首選治療方法。因此，現在當您查看一線黑色素瘤的首選治療方案時，它們都是雙 IO，OPDIVO、YERVOY 或 Opdualag。我認為這是對針對一線環境的雙重 I-O 治療重要性的一個非常重要的認識。 Opdualag 將繼續在那裡發揮非常重要的機會。然後除了黑色素瘤，顯然，薩米特已經闡明了那裡的一些機會。薩米特？

Yes. Just carrying on from there. For the non-small cell lung cancer, look, it's not a bar we have set for success. But because it's a randomized Phase II study, the bar and the statistical programming is actually within the study. Comparing the combination of Opdualag with chemotherapy versus nivolumab plus chemotherapy, it gives us 2 elements. One is the contribution of relatlimab to Opdualag plus chemotherapy. And second, the differentiation and superiority if we can find one in PFS, and that's what we are trying to gather. And that data will then pave the way for initiation of our Phase III program.

是的。只是從那裡繼續。對於非小細胞肺癌，看，這不是我們為成功設定的障礙。但因為這是一項隨機的 II 期研究，所以標準和統計程序實際上在研究中。比較 Opdualag 與化療的組合與 nivolumab 加化療的組合，它給了我們兩個要素。一是 relatlimab 對 Opdualag 聯合化療的貢獻。其次，如果我們能在 PFS 中找到差異化和優勢，這就是我們正在努力收集的。這些數據將為啟動我們的 III 期計劃鋪平道路。

And in terms of other IO mechanisms and comparisons, I think you're alluding to some of the others, such as the TIGIT programs that are ongoing, and those are yet to be proven. We are certainly looking forward to more and more data presentations. We have 2 of our programs already in that space as well. And as we generate the data and we look at the external data reading out towards their final stages, we'll be able to define and decipher where the application should be for which agent. And hopefully, as we see the data, can define the future combinations as well with those agents.

就其他 IO 機制和比較而言，我認為您指的是其他一些機制，例如正在進行的 TIGIT 計劃，這些計劃尚未得到證實。我們當然期待越來越多的數據呈現。我們在該領域也已經有 2 個程序。當我們生成數據並查看外部數據讀出的最終階段時，我們將能夠定義和破譯應用程序應該用於哪個代理的位置。希望，正如我們看到的數據，可以定義未來的組合以及這些代理。

Kevin, we're running short on time here. Maybe we have time for 2 more. Can we go to our next one?

凱文，我們來的時間不多了。也許我們還有時間再來 2 次。我們可以去下一個嗎？

Your next question comes from the line of Colin Bristow of UBS.

你的下一個問題來自瑞銀的 Colin Bristow。

I also want to offer my congrats to Chris and Adam. And Giovanni, all the best in the future. I guess in terms of the clinical readouts we're going to get from you this year, the main ones that we're getting the questions that stick out are the Phase II in IPF, particularly (inaudible). I wondered if you could just walk us through your expectations for each of these and maybe even also which one you're most enthused about.

我還想向克里斯和亞當表示祝賀。喬瓦尼，未來一切順利。我想就今年我們將從您那裡獲得的臨床讀數而言，我們遇到的主要問題是 IPF 的 II 期，特別是（聽不清）。我想知道您是否可以向我們介紹一下您對這些中的每一個的期望，甚至可以告訴我們您最熱衷於哪一個。

Samit?

薩米特？

Thank you. So since I don't have an 8 ball, I'm enthused about everything. That's why we conduct the studies. Of course, LPA1 data presentation is coming up very soon. That data has given us the excitement and encouragement to be looking forward to initiation of the Phase III trials in IPF as well as in PPF. We've already talked about the Crohn's disease data that it did not have the proof of concept yet for TYK2 inhibition mechanism in IBD and looking forward to that readout, certainly later this year.

謝謝。所以因為我沒有 8 號球，所以我對一切都充滿熱情。這就是我們進行研究的原因。當然，LPA1 數據展示很快就會出現。這些數據讓我們興奮和鼓舞，期待在 IPF 和 PPF 中啟動 III 期試驗。我們已經談到了克羅恩病數據，它還沒有 IBD 中 TYK2 抑制機制的概念證明，並期待著今年晚些時候的讀數。

We'll have -- we are looking forward to the non-small cell lung cancer readout late this year, early next year for Opdualag that will pave the way for the future. But we also have several other readouts. If you think about cell therapy, we might have the ability to look for the data in additional indications for BREYANZI as well, and that will be important. You will also see the data for CLL study being presented at ASCO, which is going to be important in addition to what we talked about for COMMANDS as well. So those are all going to be critical. And we are looking forward to adding more and more in terms of our pipeline successes as we look to the future.

我們將擁有——我們期待今年年底、明年初為 Opdualag 讀取非小細胞肺癌數據，這將為未來鋪平道路。但我們還有其他幾個讀數。如果您考慮細胞療法，我們可能也有能力在 BREYANZI 的其他適應症中尋找數據，這很重要。您還將在 ASCO 上看到 CLL 研究的數據，除了我們談到的 COMMANDS 之外，這些數據也很重要。所以這些都是至關重要的。展望未來，我們期待在我們的管道成功方面增加越來越多。

Kevin, let's go to our last question, please.

凱文，讓我們回到最後一個問題。

Your last question comes from the line of Jon Hurn from Credit Suisse.

你的最後一個問題來自瑞士信貸的 Jon Hurn。

Kevin, maybe we'll go to the next question if Jon is not available.

凱文，如果喬恩不在，我們可能會轉到下一個問題。

Your next question comes from the line of Olivia Brayer from Cantor.

您的下一個問題來自 Cantor 的 Olivia Brayer。

It looks like subcu Opdivo was discontinued in some indications in Phase III, just looking at your development slide. So can you give us any more color on what led to that decision and what it means for the subcu program going forward? And then if I can just sneak in one more. How much added capacity does your new U.S. cell therapy manufacturing facility get you? Is that something we should start to expect to contribute to supply this year? Or should we be thinking about that more as a 2024 driver?

看起來 subcu Opdivo 在 III 期的某些適應症中已停產，只需查看您的開發幻燈片。那麼你能給我們更多關於導致這個決定的原因以及它對 subcu 計劃前進的意義的更多顏色嗎？然後，如果我能再偷偷進去一個。您的新美國細胞療法製造工廠能增加多少產能？這是我們應該開始期望今年對供應做出貢獻的東西嗎？還是作為 2024 年的車手，我們應該更多地考慮這一點？

Sure. Thank you, Olivia. For the first question on subcu, no. So let's clarify that. There are 2 subcu programs that we had for Opdivo. One was the syringe in vial, which is the one that we talked about before in renal cell cancer of the study that we're looking forward to the readout. The other program that we were initiating was the auto-injector program. And that is the one that we have discontinued. We didn't see more additional benefit of continuing that program at this time. So we will certainly have a readout of the subcu program in the Phase III in renal cell carcinoma. And as I said earlier, if the data are supportive and appropriate, then, of course, discussions with regulators will ensue for applying that to all other indications that Opdivo was used today as a single agent.

當然。謝謝你，奧利維亞。對於subcu的第一個問題，沒有。所以讓我們澄清一下。我們有 2 個針對 Opdivo 的 subcu 程序。一個是小瓶中的注射器，這是我們之前在腎細胞癌研究中談到的那個，我們期待著讀出。我們發起的另一個項目是自動注射器項目。那就是我們已經停止的那個。我們目前沒有看到繼續該計劃的更多額外好處。因此，我們肯定會讀出腎細胞癌 III 期的 subcu 程序。正如我之前所說，如果數據是支持性的和適當的，那麼，當然，與監管機構的討論將隨之而來，將其應用於 Opdivo 今天作為單一藥物使用的所有其他跡象。

And let me quickly take the capacity question. So first, as you look at cell therapy across the board, we are increasing capacity. We anticipate to continue to increase capacity this year as well as going into next year. That said, within the context of CAR-T, you have to stay consistently focused on manufacturing. And remember, we have a threefold approach to how we're doing that. First, we're staying focused on manufacturing success rate. That's important on the liability point that I made previously. Second, and this is where the Illinois facility comes into play is we've got to increase vector supply. We have a dual sourcing strategy for that, both leveraging external partners as well as internalizing vector. And clearly, the acquisition of the Liberty Bill facility is important in that regard.

讓我快速回答容量問題。因此，首先，當您全面審視細胞療法時，我們正在提高產能。我們預計今年和明年將繼續增加產能。也就是說，在 CAR-T 的背景下，你必須始終專注於製造。請記住，我們採用三重方法來實現這一點。首先，我們一直專注於製造成功率。這對我之前提出的責任點很重要。其次，這就是伊利諾斯工廠發揮作用的地方，我們必須增加病媒供應。我們為此制定了雙重採購策略，既利用外部合作夥伴又利用內部化向量。顯然，在這方面獲得自由法案設施很重要。

And then finally, of course, is drug product. And there, we've made a number of investments, including facilities in Devens, Massachusetts and (inaudible) in the Netherlands. As for when the vector facility in Illinois will be up and running, we need to take ownership of the facility first. And then we've got to complete all of the site onboarding. And there's a fairly complex process in terms of tech transfer that's going to be required. So we anticipate it's going to take about 18 months from when we fully acquired the site, which would put that meaningfully contributing as we get into 2025.

最後，當然是藥品。在那裡，我們進行了大量投資，包括在馬薩諸塞州德文斯和荷蘭（聽不清）的設施。至於伊利諾伊州的載體設施什麼時候啟動運行，我們需要先取得設施的所有權。然後我們必須完成所有網站入職。在需要的技術轉讓方面有一個相當複雜的過程。因此，我們預計從我們完全收購該網站開始大約需要 18 個月的時間，這將在我們進入 2025 年時做出有意義的貢獻。

Thank you, Chris and Samit. Thanks, Olivia, and thanks, everyone. So to summarize, a strong start of the year with double-digit growth of our in-line and new product portfolio, on track for the year to grow top and bottom line, as we discussed earlier. And we feel good about where we are after the first quarter. The team will be available after your very busy day to answer any other questions you may have. And I want to thank all of you for participating in the call. Thank you and have a good day.

謝謝克里斯和薩米特。謝謝，奧利維亞，謝謝大家。總而言之，正如我們之前討論的那樣，今年開局強勁，我們的在線和新產品組合實現兩位數增長，今年有望實現收入和利潤增長。我們對第一季度後的狀況感到滿意。在您忙碌了一天之後，該團隊將有空回答您可能遇到的任何其他問題。我要感謝大家參與電話會議。謝謝你，有一個美好的一天。

That does conclude our conference for today. Thank you for participating. You may now all disconnect.

我們今天的會議到此結束。感謝您的參與。您現在可能會全部斷開連接。