施貴寶 (BMY) 2023 Q2 法說會逐字稿

Good morning, everyone. Welcome to the Bristol-Myers Squibb Second Quarter 2023 Earnings Conference Call. (Operator Instructions) Please also note, today's event is being recorded.

大家，早安。歡迎參加百時美施貴寶 2023 年第二季度收益電話會議。 （操作員說明）另請注意，今天的活動正在錄製中。

At this time, I'd like to turn the floor over to Tim Power, Vice President of Investor Relations. Mr. Power, please go ahead.

現在，我想請投資者關係副總裁蒂姆·鮑爾 (Tim Power) 發言。鮑爾先生，請繼續。

Thank you. Good morning, everyone, and thanks for joining us this morning for our second 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; Adam Lenkowsky, our Chief Commercialization Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development.

謝謝。大家早上好，感謝您今天早上參加我們的 2023 年第二季度財報電話會議。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運營官 Chris Boerner； Adam Lenkowsky，我們的首席商業化官；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. 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.

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。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。

These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com.

這些前瞻性陳述代表了我們截至目前的估計，不應被視為代表我們截至未來任何日期的估計。即使我們的估計發生變化，我們特別不承擔更新前瞻性陳述的義務。我們還將重點關注我們的非公認會計準則財務指標，這些指標經過調整以排除某些特定項目。某些非 GAAP 財務指標與最具可比性 GAAP 指標的調節表可在 bms.com 上找到。

With that, I'll hand it over to Giovanni.

這樣，我就把它交給喬瓦尼了。

Thank you, Tim, and good morning, everyone. Starting on Slide 4. As you will have seen in our press release this morning, today, we updated our outlook for 2023. The updates were driven by a significant change in our expectations for Revlimid and, to a lesser extent, Pomalyst for the year. Let me say that we do not take an adjustment of this magnitude lightly. Before I provide you with more detail, when I look at the company overall, I'm encouraged by the strength of the in-line and new products as well as the progress with our pipeline. These are the drivers that will enable us to renew our portfolio and strengthen our business in the future. The impact we are discussing today is limited to Revlimid and, to a lesser extent, Pomalyst, and we expect it to be relevant only to this year, as I'll discuss shortly.

謝謝蒂姆，大家早上好。從幻燈片 4 開始。正如您在今天早上的新聞稿中看到的那樣，今天，我們更新了 2023 年的展望。這些更新是由於我們對 Revlimid 以及在較小程度上對 Pomalyst 的預期發生重大變化而推動的。我想說的是，我們不會輕易做出如此幅度的調整。在向您提供更多詳細信息之前，當我縱觀公司整體時，我對內嵌產品和新產品的實力以及我們管道的進展感到鼓舞。這些推動力將使我們能夠在未來更新我們的產品組合併加強我們的業務。我們今天討論的影響僅限於 Revlimid，並在較小程度上影響 Pomalyst，我們預計它僅與今年相關，正如我將很快討論的那樣。

Importantly, our in-line and new product portfolios remain on track. We are pleased with continued strong performance from our in-line business and are confident in our ability to roughly double revenue from our new products this year. In fact, our new product portfolio is already annualizing at $3.5 billion as of Q2. As a result of these strong trends, we are reaffirming all our financial commitments for the 2020-2025 period.

重要的是，我們的內嵌產品和新產品組合仍保持在正軌上。我們對我們的內嵌業務持續強勁的業績感到高興，並對我們今年新產品的收入大約翻一番的能力充滿信心。事實上，截至第二季度，我們的新產品組合年化價值已達 35 億美元。由於這些強勁趨勢，我們重申 2020-2025 年期間的所有財務承諾。

Given our confidence in our future, this morning we also announced our intention to execute a $4 billion accelerated share repurchase in the third quarter.

鑑於我們對未來的信心，今天早上我們還宣布打算在第三季度執行 40 億美元的加速股票回購。

Let me now provide some details on today's update. Our revised guidance reflects a $1 billion decrease for Revlimid, and we are now guiding to approximately $5.5 billion in 2023. Combined with a roughly $300 million impact for Pomalyst, these changes account for our revised guidance on revenue and EPS ranges. As you know, we are navigating generic entry for Revlimid, though this is not the driver of our revision in outlook. Concurrent with entry of the most recent wave of generic volumes, we saw some softness in Revlimid sales beginning at the end of the first quarter.

現在讓我提供有關今天更新的一些詳細信息。我們修訂後的指導反映了 Revlimid 減少了 10 億美元，我們現在的指導是 2023 年約為 55 億美元。加上 Pomalyst 約 3 億美元的影響，這些變化說明了我們對收入和每股收益範圍的修訂指導。如您所知，我們正在導航 Revlimid 的通用條目，儘管這不是我們在 Outlook 中進行修訂的驅動因素。在最近一波仿製藥進入的同時，我們看到來那度胺 (Revlimid) 銷售從第一季度末開始出現一些疲軟。

As we looked into its drivers, we recognized there had been an unusual increase in utilization of 3 drugs provided by the independent BMS Patient Assistance Foundation starting at the same time. In Q2, the number of patients on free drug continued to increase and reached a level significantly higher than normal. The impact on Revlimid and Pomalyst revenues also accelerated in Q2. This issue is the main driver of our revised guidance.

當我們調查其驅動因素時，我們認識到獨立的 BMS 患者援助基金會同時開始提供的 3 種藥物的使用量出現了異常增長。第二季度，免費用藥患者數量持續增加，達到明顯高於正常水平。第二季度對 Revlimid 和 Pomalyst 收入的影響也加速了。這個問題是我們修訂指南的主要驅動力。

The situation is complex, and to explain it, I'll turn to Slide 5 to remind everyone of some of the ways we meet our commitment to support eligible patients who can't afford their medicines. For commercially insured patients, we provide the co-pay support to eligible patients. Under U.S. law, however, we cannot provide co-pay support to government-insured patients, such as Medicare patients. There are third-party independent charitable foundations that provide financial assistance to patients to help with out-of-pocket costs, including Medicare patients.

情況很複雜，為了解釋這一點，我將轉向幻燈片 5，提醒大家我們履行承諾的一些方法，以支持符合條件的無力承擔藥物的患者。對於商業保險患者，我們為符合條件的患者提供自付費用支持。但是，根據美國法律，我們無法向政府保險患者（例如 Medicare 患者）提供自付費用支持。有第三方獨立慈善基金會向患者（包括醫療保險患者）提供經濟援助，以幫助其支付自付費用。

These charitable foundations are supported financially in a variety of ways. This includes contributions from donors, including BMS, consistent with HHS guidance. Additionally, we donate BMS products to the independent BMS Patient Assistance Foundation, which provides free medicine to all qualified patients who are not financially supported elsewhere. Importantly, to comply with government guidance, once patients enter this program, the BMS Patient Assistance Foundation provides free product through the end of the calendar year.

這些慈善基金會通過多種方式獲得財政支持。這包括捐助者（包括 BMS）的捐款，符合 HHS 的指導。此外，我們還向獨立的 BMS 患者援助基金會捐贈 BMS 產品，該基金會為所有在其他地方得不到經濟支持的合格患者提供免費藥品。重要的是，為了遵守政府指導，一旦患者加入該計劃，BMS 患者援助基金會將在日曆年年底之前提供免費產品。

Earlier this year, funds at independent third-party charitable foundations, the ones that provide financial assistance to eligible multiple myeloma patients, closed for a period of time. This was because the collective funding from donors was not sufficient to meet the need for co-pay assistance for the patients taking the variety of medicines that the multiple myeloma funds support. We believe the funds closing for a period of time was the primary driver for an increase in patients requesting free product from the independent BMS Patient Assistance Foundation.

今年早些時候，為符合條件的多發性骨髓瘤患者提供經濟援助的獨立第三方慈善基金會的基金關閉了一段時間。這是因為捐助者的集體資金不足以滿足服用多發性骨髓瘤基金支持的各種藥物的患者的共同支付援助需求。我們認為，一段時間內的資金關閉是患者向獨立的百時美施貴寶患者援助基金會索要免費產品的人數增加的主要原因。

During the second quarter, the level of free product utilization continued to increase, and ultimately, reached a level that was significantly higher than normal. These dynamics were building while we were also navigating the most recent wave of generic volumes for Revlimid. Today, we are able to provide you with an update on our company guidance for the year that incorporates the impact from both Revlimid and Pomalyst.

第二季度，免費產品使用率持續上升，最終達到明顯高於正常水平的水平。當我們也在探索 Revlimid 的最新一波仿製藥時，這些動態正在形成。今天，我們能夠向您提供公司今年指引的最新信息，其中包含 Revlimid 和 Pomalyst 的影響。

I want to underscore that we do not expect these dynamics to continue into next year. This is based on 2 key factors. First, the BMS Patient Assistance Foundation has seen applications for free product returning to normal levels. Second, changes in Medicare Part D coverage, taking effect in 2024, will help improve patient affordability. This should directly impact the number of patients needing to access the free drug program.

我想強調的是，我們預計這些動態不會持續到明年。這是基於兩個關鍵因素。首先，BMS 患者援助基金會發現免費產品的申請已恢復到正常水平。其次，醫療保險 D 部分承保範圍的變化將於 2024 年生效，將有助於提高患者的負擔能力。這將直接影響需要獲得免費藥物計劃的患者數量。

So to sum up what this means financially, we estimate the impact of the increase in patients receiving free product to be approximately $330 million for Revlimid and Pomalyst in Q2, with about 80% of that being Revlimid. Because the BMS Patient Assistance Foundation provides free drug for the calendar year, the impact for Revlimid and Pomalyst will be more significant for the full year, approximately $1 billion and $300 million, respectively.

因此，總結一下這對財務意味著什麼，我們估計第二季度接受免費產品的患者增加對 Revlimid 和 Pomalyst 的影響約為 3.3 億美元，其中約 80% 是 Revlimid。由於 BMS 患者援助基金會全年提供免費藥物，因此 Revlimid 和 Pomalyst 全年的影響將更為顯著，分別約為 10 億美元和 3 億美元。

Since revenues for Revlimid are lower than expected this year, we now expect a lower step-down of approximately $1.5 billion in 2024 and $2 billion in 2025.

由於 Revlimid 今年的收入低於預期，我們現在預計 2024 年收入將減少約 15 億美元，2025 年收入將減少 20 億美元。

Now turning back to the products that will be key to our future. Let me turn to Slide 6, and our new products. Here, you can see that we continue to deliver very strong growth and remain on track to roughly double revenue for this portfolio this year. David will provide more details in a few minutes, and we see good momentum and growth opportunities across the portfolio, including progress with accelerating access for SOTYKTU, building demand and conversion to commercial dispense for Camzyos in the U.S. and achieving approval in Europe, continuing to build capacity for our cell therapy assets, as well as growing Reblozyl in its current indications in advance of an exciting future launch will commence.

現在回到對我們未來至關重要的產品。讓我談談幻燈片 6 和我們的新產品。在這裡，您可以看到我們繼續實現非常強勁的增長，並且今年該投資組合的收入仍有望實現大約翻一番。 David 將在幾分鐘內提供更多詳細信息，我們看到整個產品組合的良好勢頭和增長機會，包括加速 SOTYKTU 准入、在美國建立需求和 Camzyos 向商業分配的轉變以及在歐洲獲得批准方面取得的進展，繼續為我們的細胞治療資產建設能力，並在令人興奮的未來推出之前根據當前的適應症不斷發展 Reblozyl。

On Slide 7, I would like to remind you of the targets we provided for our product portfolio. The process of renewing our portfolio and growing the business for the long-term centers, first, on our 9 recently launched products. The combination of our scientific innovation and commercial execution gives us great confidence in the growth trajectory of these set of products. We continue to expect to deliver $10 billion to $13 billion of revenue from this portfolio in 2025. And the opportunity remains significant with $25 billion plus or potential revenue in 2030 on a nonrisk-adjusted basis.

在幻燈片 7 上，我想提醒您我們為產品組合提供的目標。更新我們的產品組合併發展長期中心業務的過程，首先是我們最近推出的 9 種產品。我們的科學創新和商業執行的結合使我們對這一系列產品的增長軌跡充滿信心。我們仍然預計 2025 年該投資組合將帶來 100 億至 130 億美元的收入。而且，在非風險調整的基礎上，到 2030 年，機會仍然很大，250 億美元以上或潛在的收入。

Importantly, we are continuing to further derisk these products with opportunities such as commands for Reblozyl, CLL and follicular and mantle cell lymphoma for Breyanzi, and many more. Which brings me to our scorecard, outlining our strong pipeline execution on Slide 8. As I mentioned, we are making progress derisking our new products as well as accelerating our pipeline more broadly. And we achieved some important clinical milestones this quarter.

重要的是，我們將繼續利用 Reblozyl、CLL 以及 Breyanzi 的濾泡和套細胞淋巴瘤等機會進一步降低這些產品的風險。這讓我想到了我們的記分卡，在幻燈片 8 上概述了我們強大的管道執行力。正如我所提到的，我們在降低新產品風險以及更廣泛地加速我們的管道方面取得了進展。本季度我們實現了一些重要的臨床里程碑。

During the second quarter, we presented exciting data for our LPA1 agonist in idiopathic pulmonary fibrosis. The Phase II data for this drug showed more than a 60% reduction in the rate of decline in lung function without any of the GI tolerability issues associated with existing drugs. With the proof-of-concept also achieved in progressive pulmonary fibrosis, we look forward to presenting more data for this asset, and we are rapidly moving to Phase III trials.

在第二季度，我們展示了 LPA1 激動劑治療特發性肺纖維化的令人興奮的數據。該藥物的 II 期數據顯示，肺功能下降率降低了 60% 以上，且不存在任何與現有藥物相關的胃腸道耐受性問題。隨著在進行性肺纖維化方面也取得了概念驗證，我們期待為該資產提供更多數據，並且我們正在迅速進入 III 期試驗。

ASCO and EHA were important meetings for us this year. In addition to presenting the Reblozyl COMMANDS data, strong data was presented for Opdivo in first-line classical Hodgkin lymphoma and for our GPRC5D cell therapy program in multiple myeloma. And we are excited to move this into registrational trials. These underpin the growth potential of our I-O franchise and the incredibly exciting opportunities we see ahead for our leading cell therapy platform, including into new areas such as immunologic diseases.

ASCO 和 EHA 對我們來說是今年的重要會議。除了提供 Reblozyl COMMANDS 數據外，還提供了 Opdivo 在一線經典霍奇金淋巴瘤和我們的 GPRC5D 細胞治療項目在多發性骨髓瘤中的強有力數據。我們很高興將其納入註冊試驗。這些支撐了我們 I-O 特許經營權的增長潛力，以及我們為領先的細胞治療平台看到的令人難以置信的令人興奮的機會，包括進入免疫疾病等新領域。

We have also announced a positive outcome from our [CheckMate -901] trial of Opdivo and chemotherapy in cisplatin-eligible first-line metastatic bladder cancer. Not only is this a very positive development for these patients, it speaks to the breadth of opportunity in our pipeline beyond what's shown on this slide. We have a rich and broad pipeline that we continue to advance rapidly. We're looking forward to sharing more about the opportunities we see coming from our scientific research at our R&D Day in September.

我們還宣布了 Opdivo 聯合化療治療符合順鉑一線轉移性膀胱癌的 [CheckMate -901] 試驗取得了積極結果。這不僅對這些患者來說是一個非常積極的進展，而且還說明了我們的管道中存在超出這張幻燈片所示內容的廣泛機會。我們擁有豐富而廣泛的產品線，並將繼續快速推進。我們期待在九月的研發日分享更多關於我們從科學研究中看到的機會。

Now I'd like to spend a minute to take stock of where we are on our portfolio renewal journey. Turning to Slide 9. With 60% of the Revlimid erosion behind us at the end of 2023, we are well on track to meet our commitment of growing revenue low to mid-single-digit CAGR from 2020 to 2025. When, as we have told you, our recent LOEs will represent at most 10% of our revenue. The profitability of our business with operating margin of at least 40% provides us with the financial flexibility needed to continue to invest in our future.

現在我想花一點時間來評估一下我們的投資組合更新之旅的進展情況。轉向幻燈片 9。到 2023 年底，來那度胺 (Revlimid) 的 60% 侵蝕已經過去，我們有望實現 2020 年至 2025 年收入複合年增長率從低至中個位數增長的承諾。告訴你，我們最近的 LOE 最多占我們收入的 10%。我們業務的盈利能力（營業利潤率至少為 40%）為我們提供了繼續投資未來所需的財務靈活性。

Turning now to Slide 10. I want to reiterate that our focus and our confidence in the renewal of our portfolio are as strong as ever. This rests on our in-line and new product portfolios and our pipeline as the key drivers of our performance beyond 2025, and we are pleased with where we are. There are 4 important levers which will enable us to renew our portfolio in the second half of the decade as Eliquis and Opdivo lose exclusivity.

現在轉向幻燈片 10。我想重申，我們對更新投資組合的關注和信心一如既往。這取決於我們的在線產品和新產品組合以及我們的管道，它們是我們 2025 年以後業績的關鍵驅動力，我們對目前的狀況感到滿意。隨著 Eliquis 和 Opdivo 失去獨家經營權，有 4 個重要的槓桿將使我們能夠在本世紀後半葉更新我們的產品組合。

The continued growth of the 9 medicines in our new product portfolio from $10 billion, $13 billion in 2025 to realization of their full potential of at least $25 billion of nonrisk-adjusted revenue by the end of the decade; the potential launch of 6 registrational stage assets with meaningful contributions before the end of the decade; continued progress with our early-stage pipeline and potential external innovation through business development. We are executing well on all 4 fronts. I'm excited and confident about what the future holds for Bristol-Myers Squibb.

我們新產品組合中的 9 種藥物持續增長，從 2025 年的 100 億美元到 130 億美元，到本十年末充分發揮其非風險調整收入至少 250 億美元的潛力；可能在本十年結束之前推出 6 個具有有意義貢獻的註冊階段資產；通過業務發展，我們的早期研發管線和潛在的外部創新不斷取得進展。我們在四個方面都表現良好。我對百時美施貴寶的未來感到興奮和充滿信心。

Before I turn the call over to David, I want to thank our teams globally for their commitment to our patients and focus on our business. David will now walk you through our product performance and financial results in more detail. David?

在將電話轉給 David 之前，我要感謝我們的全球團隊對患者的承諾以及對我們業務的關注。 David 現在將向您詳細介紹我們的產品性能和財務業績。大衛？

Thank you, Giovanni, and thank you all for joining our second quarter earnings call. Let's turn to Slide 12 to discuss our top line performance. Unless otherwise stated, all comparisons are made versus same period in 2022, and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange.

謝謝喬瓦尼，也感謝大家參加我們的第二季度財報電話會議。讓我們轉向幻燈片 12 來討論我們的營收表現。除非另有說明，所有比較均與 2022 年同期進行，銷售增長率將在基礎基礎上討論，不包括外彙的影響。

Total company sales in the second quarter were $11.2 billion, driven by continued strength of our in-line and new product portfolio, offset by the [Revlimid] decline that Giovanni discussed earlier. At the same time, we continue to be pleased with the strong growth of our new product portfolio, which grew 79% in the quarter.

第二季度公司總銷售額為 112 億美元，這得益於我們的內嵌產品和新產品組合的持續強勁，但被 Giovanni 之前討論的 [Revlimid] 下降所抵消。與此同時，我們繼續對新產品組合的強勁增長感到高興，該產品組合在本季度增長了 79%。

Moving to our new product portfolio on Slide 13. I'm incredibly proud of the strong momentum in the quarter and pleased with the growth. The portfolio generated $862 million in sales in the quarter, already annualizing approximately $3.5 billion. New products grew significantly in the quarter and year-to-date, with 79% and 91% growth, respectively, versus last year. This strong performance was driven by several of our key products across the portfolio including [Opdualag], Reblozyl and our cell therapies, Breyanzi and Abecma, as well as Camzyos and Zeposia.

轉到幻燈片 13 上我們的新產品組合。我對該季度的強勁勢頭感到無比自豪，並對增長感到滿意。該產品組合在本季度創造了 8.62 億美元的銷售額，年化銷售額約為 35 億美元。本季度和年初至今新產品增長顯著，與去年相比分別增長了 79% 和 91%。這種強勁的業績是由我們整個產品組合中的幾個關鍵產品推動的，包括 [Opdualag]、Reblozyl 和我們的細胞療法、Breyanzi 和 Abecma，以及 Camzyos 和 Zeposia。

Moving to our solid tumor performance on Slide 14. Global Opdivo sales year-to-date were strong, growing 11% versus prior year, primarily driven by a continued demand for our newly launched and core indications. In the U.S., Opdiva grew 2% in the quarter versus last year, driven by demand in first-line lung, gastric and adjuvant bladder cancer indications, offset by customer buying patterns. Sequentially, we estimate these buying patterns to be about $50 million to $100 million.

轉向幻燈片 14 上我們的實體瘤業績。年初至今，Opdivo 的全球銷售額強勁，比上年增長 11%，這主要是由於對我們新推出的核心適應症的持續需求所推動。在美國，Opdiva 在一線肺癌、胃癌和輔助膀胱癌適應症需求的推動下，本季度較去年增長了 2%，但被客戶購買模式所抵消。因此，我們估計這些購買模式約為 5000 萬至 1 億美元。

Importantly, year-to-date revenues were up 9% versus last year, with continued growth expected this year. Outside the U.S., second quarter revenues increased 10%, driven by demand for recently launched indications and expanded access.

重要的是，今年迄今為止的收入比去年增長了 9%，預計今年將繼續增長。在美國以外地區，由於對最近推出的適應症和擴大准入的需求的推動，第二季度收入增長了 10%。

Moving to the strong launch of Opdualag. Sales in the quarter grew significantly over prior year with revenues of $154 million. This also represents 31% growth versus prior quarter. We're extremely pleased with the launch of Opdualag in first-line melanoma with market share approaching 25% and continuing to be primarily sourced from PD-1 monotherapy. Positive experiences are driving repeat and expanded use across patients. This momentum gives us confidence in the ability for Opdualag to become the new standard of care in first-line melanoma.

接下來是 Opdualag 的強勢推出。本季度銷售額較上年大幅增長，收入達 1.54 億美元。這也意味著與上一季度相比增長了 31%。我們對 Opdualag 在一線黑色素瘤中的推出感到非常高興，其市場份額接近 25%，並且繼續主要來自 PD-1 單一療法。積極的體驗正在推動患者重複使用並擴大使用。這一勢頭讓我們對 Opdualag 成為一線黑色素瘤治療新標準的能力充滿信心。

Transitioning to our cardiovascular portfolio on Slide 15, beginning with Eliquis. We continue to be pleased with our leading OAC, which generated sales of approximately $3.2 billion globally, largely driven by the U.S., where sales grew 7% year-over-year driven primarily by demand. Sequentially, as is typical in the second quarter, we started to experience unfavorable gross to net adjustments as patients enter into the donut hole. As a reminder, these dynamics are more acute in the third and fourth quarters with the second half revenues being lower than the first half as we see each year. Outside the U.S., sales continue to be impacted primarily by generic entries in Canada and the U.K. as well as government pricing measures we mentioned in the past.

過渡到幻燈片 15 上我們的心血管產品組合，從 Eliquis 開始。我們仍然對我們領先的 OAC 感到滿意，該公司在全球範圍內創造了約 32 億美元的銷售額，這主要是由美國推動的，美國的銷售額同比增長了 7%，這主要是由需求推動的。隨後，正如第二季度的典型情況一樣，隨著患者進入甜甜圈洞，我們開始經歷不利的總淨調整。提醒一下，這些動態在第三和第四季度更加嚴重，下半年的收入低於上半年，正如我們每年看到的那樣。在美國以外的地區，銷售繼續主要受到加拿大和英國的仿製藥進入以及我們過去提到的政府定價措施的影響。

Turning to Camzyos, which generates sales of $46 million in the quarter, we are pleased with our continued progress. We are seeing healthy increases in patients being treated week-over-week with approximately 3,800 patients in our hub, of which approximately 2,500 patients are on commercial drug at the end of the quarter. We continue to make great progress with centers of excellence and broadening our prescriber base into the community setting. Patients have highlighted significant improvement in symptoms, which has resulted in strong adherence and minimal drop-off.

至於 Camzyos，該公司本季度的銷售額為 4600 萬美元，我們對我們的持續進步感到高興。我們看到接受治療的患者數量逐週呈健康增長，中心約有 3,800 名患者，其中截至本季度末約有 2,500 名患者正在接受商業藥物治療。我們繼續在卓越中心方面取得巨大進展，並將我們的處方者基礎擴大到社區環境。患者強調症狀顯著改善，這導致了強烈的依從性和最小的下降。

We are delighted to have updated the label for Camzyos based upon the VALOR study, which reinforces the strong data seen in the EXPLORER study and further strengthens the clinical profile of Camzyos. Outside of the U.S., we're excited to have received European approval last month, and look forward to making this first-in-class medicine available to more patients once we secure reimbursement.

我們很高興根據 VALOR 研究更新了 Camzyos 的標籤，這強化了 EXPLORER 研究中看到的強有力的數據，並進一步加強了 Camzyos 的臨床概況。在美國之外，我們很高興上個月獲得歐洲批准，並期待在獲得報銷後向更多患者提供這種一流的藥物。

Now turning to our hematology portfolio on Slide 16, and I won't go into details on Revlimid and Pomalyst since Giovanni already discussed them earlier. I'll turn to Reblozyl. We had a strong quarter with revenues of $234 million, from 35% versus the prior year, primarily driven by demand. In the U.S., revenues grew 24%, primarily due to continued total prescription share growth driven by longer duration of treatment. Internationally, Reblozyl roughly doubled as we continue to secure reimbursement in additional countries.

現在轉向幻燈片 16 上的血液學產品組合，我不會詳細介紹 Revlimid 和 Pomalyst，因為 Giovanni 之前已經討論過它們。我會轉向Reblozyl。我們的季度表現強勁，收入達到 2.34 億美元，較上年同期增長 35%，這主要是由需求推動的。在美國，收入增長了 24%，主要是由於治療持續時間延長推動總處方份額持續增長。在國際上，隨著我們繼續在更多國家獲得報銷，Reblozyl 大約增加了一倍。

We have a strong foundation in place and look forward to the upcoming PDUFA date for Reblozyl in first-line ESA-naive MDS patients on the COMMANDS data, which will further accelerate growth of the band upon anticipated approval at the end of next month. Moving on to our transformative cell therapy products, Abecma and Breyanzi, we continue to make progress at expanding capacity which has enabled robust sales of $232 million, growing 81% versus prior year, driven by strong demand.

我們已經奠定了堅實的基礎，並期待根據 COMMANDS 數據，即將到來的 Reblozyl 在一線 ESA 初治 MDS 患者中的 PDUFA 日期，這將在下月底預計獲得批准後進一步加速該藥物的增長。接下來是我們的變革性細胞治療產品 Abecma 和 Breyanzi，我們在擴大產能方面繼續取得進展，在強勁需求的推動下，銷售額實現了 2.32 億美元的強勁銷售額，比去年增長了 81%。

Abecma booked sales of $132 million globally, growing 48% versus last year, primarily due to demand and an increase in manufacturing capacity. We expect third quarter revenues to be lower than second quarter revenues due in part to planned manufacturing maintenance in June, with growth expected in the fourth quarter. Having said that, we continue to be pleased with the reproducibility of our efficacy and safety data in the real world and the reliability of our manufacturing processes, which were reinforced at ASCO. We also look forward to the upcoming PDUFA date in December for Abecma in early lines based on the KarMMA-3 trial.

Abecma 全球銷售額為 1.32 億美元，比去年增長 48%，這主要是由於需求和製造能力的增加。我們預計第三季度收入將低於第二季度收入，部分原因是六月份計劃進行生產維護，預計第四季度將出現增長。話雖如此，我們仍然對現實世界中功效和安全數據的可重複性以及我們製造工藝的可靠性感到滿意，這些都在 ASCO 得到了加強。我們還期待 Abecma 在基於 KarMMA-3 試驗的早期生產線中於 12 月即將到來的 PDUFA 日期。

Turning to Breyanzi, which generated sales of $100 million globally, more than doubling versus prior year and 41% sequentially, primarily driven by demand in second line and third line large B-cell lymphoma and increased manufacturing capacity. We are pleased with our success in increasing supply. While factor constraints will result in third and fourth quarter revenues being largely similar to second quarter, we are further building out our capacity for growth next year. Outside the U.S., we're excited about the EU approval of Breyanzi in second-line large B-cell lymphoma and look forward to bringing this treatment to early aligned patients in Europe.

說到 Breyanzi，該公司在全球範圍內實現了 1 億美元的銷售額，比上年增長了一倍多，環比增長 41%，這主要是受到二線和三線大 B 細胞淋巴瘤的需求以及生產能力增加的推動。我們對增加供應的成功感到高興。雖然因素限制將導致第三季度和第四季度的收入與第二季度基本相似，但我們正在進一步增強明年的增長能力。在美國之外，我們對歐盟批准 Breyanzi 用於二線大 B 細胞淋巴瘤治療感到興奮，並期待將這種治療方法帶給歐洲的早期患者。

Now let's turn to our immunology portfolio on Slide 17. And Global sales of Zeposia in the quarter were $100 million, growing 52% compared to prior year and 28% sequentially. In the U.S., growth was primarily driven by demand in multiple sclerosis and expanding contribution from ulcerative colitis. Outside the U.S., sales increased year-over-year, primarily due to demand in multiple sclerosis and securing reimbursement in additional countries.

現在讓我們轉向幻燈片 17 上的免疫學產品組合。本季度 Zeposia 的全球銷售額為 1 億美元，比去年同期增長 52%，比上一季度增長 28%。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不斷擴大推動的。在美國以外的地區，銷售額同比增長，主要是由於多發性硬化症的需求以及其他國家的報銷。

And lastly, turning to SOTYKTU. We are extremely pleased with the launch and progress we've made to date. Since launch, we have a greater than 23,000 script equivalents across bridge and commercial drug, nearly doubling volume in Q2 versus Q1. SOTYKTU's share of the oral market is now approaching 40%, continue to source more business from systemic-naive patients as well as Otezla in biologic experience patients.

最後，轉向 SOTYKTU。我們對迄今為止的發布和取得的進展感到非常滿意。自推出以來，我們在橋樑和商業藥物方面擁有超過 23,000 個等效腳本，第二季度的數量幾乎是第一季度的兩倍。 SOTYKTU 的口服市場份額現已接近 40%，繼續從系統初治患者以及生物經驗患者中的 Otezla 獲得更多業務。

I'm also very pleased to report that we've made progress accelerating access, most notably, half of CVS plans were zero step edits effective mid-July. CVS indication-based plans account for approximately 30 million people or roughly 15% of the commercial covered lives, and we look forward to securing broader formulary access in 2024. Outside U.S., we continue to be pleased with the strong launch performance in Japan and are working with various countries across Europe to secure reimbursement.

我還非常高興地報告，我們在加速訪問方面取得了進展，最值得注意的是，一半的 CVS 計劃是零步驟編輯，於 7 月中旬生效。基於 CVS 適應症的計劃覆蓋約 3000 萬人，約佔商業承保人壽的 15%，我們期待在 2024 年獲得更廣泛的處方准入。在美國之外，我們繼續對日本的強勁推出表現感到滿意，並且與歐洲各國合作以確保報銷。

Now moving to our second quarter P&L on Slide 18. I'll focus my remarks on a few non-GAAP key line items having just covered the $11.2 billion of sales in the quarter. In the quarter, gross margin of approximately 75% was primarily impacted by product mix. Operating expenses of $4.2 billion, excluding acquired in-process R&D, increased approximately 2% versus last year, largely driven by an increase in spend to support our new product portfolio. Acquired in-process R&D in the quarter was $158 million, which was partially offset by $20 million of licensing income. Overall, second quarter earnings per share was $1.75.

現在轉向幻燈片 18 上的第二季度損益表。我將重點討論幾個非 GAAP 關鍵項目，這些項目剛剛涵蓋了本季度 112 億美元的銷售額。本季度毛利率約為 75%，主要受到產品組合的影響。運營費用為 42 億美元（不包括收購的正在進行的研發），與去年相比增加了約 2%，這主要是由於支持我們新產品組合的支出增加所致。本季度獲得的正在進行的研發費用為 1.58 億美元，部分被 2000 萬美元的許可收入所抵消。總體而言，第二季度每股收益為 1.75 美元。

Turning to the balance sheet and capital allocation on Slide 19. Cash flow generation on our balance sheet remained strong. Cash flow from operations in the quarter was approximately $1.9 billion, with over $8.7 billion in cash and marketed securities on hand as of June 30. Cash flow from operations in the quarter was primarily impacted by a $3 billion tax payments in the quarter, which is dynamic as we've seen in previous years.

轉向幻燈片 19 上的資產負債表和資本配置。我們資產負債表上的現金流生成仍然強勁。本季度運營現金流約為 19 億美元，截至 6 月 30 日，手頭有超過 87 億美元現金和上市證券。本季度運營現金流主要受到本季度 30 億美元稅款的影響，其中正如我們前幾年所看到的那樣充滿活力。

Our priorities for capital allocation remain unchanged, our business development continuing to be a top priority and a focus on balance sheet strength as well as returning capital to shareholders. In the quarter, we repaid approximately $240 million of debt and $1.9 billion year-to-date, with an additional $2 billion maturing this year. Additionally, as Giovanni mentioned, we intend to execute a $4 billion ASR in the third quarter of this year, with approximately $2 billion remaining in our share repurchase authorization after the ASR.

我們的資本配置優先事項保持不變，我們的業務發展仍然是重中之重，並註重資產負債表實力以及向股東返還資本。本季度，我們償還了約 2.4 億美元的債務和年初至今的 19 億美元債務，今年還有 20 億美元到期。此外，正如喬瓦尼提到的，我們打算在今年第三季度執行 40 億美元的 ASR，ASR 後我們的股票回購授權中還剩下大約 20 億美元。

Turning to our updated 2023 non-GAAP guidance on Slide 20. Our updated guidance reflects the decline of Revlimid and, to a lesser extent, Pomalyst revenues Giovanni mentioned earlier. We now expect 2023 revenues to decline in the low single-digit range on a reported and ex FX basis, and gross margin is expected to be approximately 76%. Excluding the impact of acquired in-process R&D, we continue to expect low single-digit decline in operating expenses, which reflects efficiency initiatives in MS&A as we continue to invest in our new product portfolio.

轉向幻燈片 20 上更新的 2023 年非 GAAP 指引。我們更新的指引反映了 Revlimid 的下降，以及喬瓦尼之前提到的 Pomalyst 收入的下降（在較小程度上）。我們現在預計 2023 年按報告和除外匯計算的收入將在低個位數範圍內下降，毛利率預計約為 76%。排除收購的正在進行的研發的影響，我們繼續預計運營費用將出現低個位數下降，這反映了我們在繼續投資新產品組合時在 MS&A 方面的效率舉措。

For the third quarter, we expect total operating expenses to be largely similar to the second quarter and approximately $4.2 billion. Our tax rate is now expected to be 17.5%, reflecting changes in product mix and our earnings per share is now expected to be in the range of $7.35 to $7.65.

對於第三季度，我們預計總運營支出將與第二季度基本相似，約為 42 億美元。我們的稅率目前預計為 17.5%，反映了產品結構的變化，我們的每股收益目前預計在 7.35 美元至 7.65 美元之間。

Lastly, turning to Slide 21. Despite Revlimid dynamics this year,, the future of our company was driven by our in-line and new product portfolio. Importantly, the robust growth of this business remains unchanged. We continue to expect the new product portfolio to roughly double versus prior year. We are continuing to diversify our business and have become less concentrated as a result. As you can see and as Giovanni mentioned earlier, in 2025, greater than 90% of our business is expected to come from our in-line and new product portfolios.

最後，轉向幻燈片 21。儘管 Revlimid 今年表現強勁，但我們公司的未來是由我們的在線產品和新產品組合推動的。重要的是，該業務的強勁增長勢頭並未改變。我們仍然預計新產品組合將比去年增加一倍。我們正在繼續實現業務多元化，從而降低了集中度。正如您所看到的，正如 Giovanni 之前提到的，到 2025 年，我們 90% 以上的業務預計將來自我們的內嵌產品和新產品組合。

We continue to expect low to mid-single-digit CAGR for 2020 to 2025 and reaffirm our midterm outlook. Before we move to Q&A, I want to reiterate and recognize the strong execution of our teams to accelerate the momentum of the future of our company, our new product portfolio. We remain laser-focused on bringing these transformational medicines to patients around the globe.

我們繼續預計 2020 年至 2025 年復合年增長率將達到低至中個位數，並重申我們的中期前景。在我們進行問答之前，我想重申並認可我們團隊的強大執行力，以加速我們公司和新產品組合的未來勢頭。我們仍然專注於將這些變革性藥物帶給全球患者。

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

我現在將把電話轉回蒂姆和喬瓦尼進行問答。

Thanks very much, David. Jamie, can we go to the first question, please?

非常感謝，大衛。傑米，我們可以回答第一個問題嗎？

(Operator Instructions) Our first question today comes from Chris Shibutani from Goldman Sachs.

（操作員說明）今天我們的第一個問題來自高盛的 Chris Shibutani。

When we think about the new product portfolio, particularly Slide 7, where you outlined your objectives for 2025 into 2030, Camzyos sits at the top of that list in terms of being able to factor in to contribute. The initial journey, I think, is pretty clear that outlining some of the challenges of developing a new market, there's the REMS, et cetera, when do you think we're going to be able to get the kind of inflection that will build confidence in achieving those numbers, particularly approaching that $4 billion range? Many factors go into this, can you highlight sort of the most important and the potential timing there?

當我們考慮新產品組合時，特別是在幻燈片 7 中，您概述了 2025 年到 2030 年的目標，就能夠做出貢獻而言，Camzyos 名列前茅。我認為，最初的旅程非常清楚，概述了開發新市場的一些挑戰，例如 REMS 等，您認為我們什麼時候能夠獲得那種能夠建立信心的轉變如何實現這些數字，特別是接近 40 億美元的範圍？這涉及很多因素，您能強調一下最重要的因素和潛在的時機嗎？

Chris, it's Chris. I'll start, and then I'll turn it over to Adam to provide some specifics. But since you mentioned the new product portfolio, let me just highlight a few things at a macro level. First, we continue to be very confident in the progress of the new product portfolio. As you heard in the prepared remarks, we remain on track to roughly double the revenue of that portfolio. We're very much on track towards the $10 billion to $13 billion in 2025. And as Adam will highlight, I think we've made some very good progress really across that portfolio, not just Camzyos, but certainly, Adam can provide additional details on Camzyos. So Adam?

克里斯，是克里斯。我先開始，然後將其交給 Adam 提供一些細節。但既然你提到了新產品組合，讓我從宏觀層面強調一些事情。首先，我們對新產品組合的進展仍然充滿信心。正如您在準備好的發言中所聽到的那樣，我們仍然有望將該投資組合的收入大約增加一倍。我們正在朝著 2025 年 100 億至 130 億美元的目標邁進。正如 Adam 將強調的那樣，我認為我們在該投資組合上確實取得了一些非常好的進展，不僅僅是 Camzyos，而且 Adam 可以提供更多詳細信息在卡姆齊奧斯上。那麼亞當?

Yes. Chris, thanks for the question. Let me say about Camzyos, we're very pleased with the performance of Camzyos, which is on track with our launch expectations. And we're seeing, as you heard from David, week-over-week in patients treated with Camzyos, and we expect to see continued, steady and consistent growth through this important brand. Remember that the launch trajectory of Camzyos is akin to what you see from a CV product. And I used the analogy is more similar to a product like Eliquis, where continues to grow steadily.

是的。克里斯，謝謝你的提問。讓我談談 Camzyos，我們對 Camzyos 的性能非常滿意，它符合我們的發布預期。正如您從 David 那裡聽到的那樣，我們看到 Camzyos 治療的患者每週都在接受治療，我們期望通過這個重要品牌看到持續、穩定和一致的增長。請記住，Camzyos 的發布軌跡類似於您從 CV 產品中看到的軌跡。我用的比喻更類似於 Eliquis 這樣的產品，該產品持續穩定增長。

Now year-to-date, we have great momentum for both patients coming into the hub and a commensurate increase in commercial patients. So as patients continue to accumulate, we expect these patients to be on drug now for many years, multiple refills in 2023 and beyond. I think most importantly, patient feedback as well as physician feedback continues to be extremely positive. And we're also excited about the VALOR approval, which happened in the quarter, which further strengthens and solidifies the profile of Camzyos, and we'll continue to increase adoption. We're also happy about the approval in Europe as well, so we're just getting started there. So taken together, we're very confident this will lead to continued and sustained growth in 2023 and beyond.

今年迄今為止，我們的患者進入中心的勢頭強勁，商業患者也相應增加。因此，隨著患者數量的不斷增加，我們預計這些患者將繼續服藥多年，並在 2023 年及以後進行多次續藥。我認為最重要的是，患者的反饋以及醫生的反饋仍然非常積極。我們也對本季度獲得 VALOR 批准感到興奮，這進一步加強和鞏固了 Camzyos 的形象，我們將繼續提高采用率。我們也對歐洲的批准感到高興，所以我們才剛剛開始。綜上所述，我們非常有信心這將帶來 2023 年及以後的持續增長。

Thanks, Chris and Adam.

謝謝克里斯和亞當。

Our next question comes from Evan Seigerman from BMO.

我們的下一個問題來自 BMO 的 Evan Seigerman。

I'd love for you to walk me through a little bit more of the rationale to do an accelerated share repurchase, just given what's happening with Revlimid and the potential to maybe you need to reinvest more in the business to grow revenues near term. Would love some color there.

我希望您能向我詳細介紹一下加速股票回購的理由，考慮到來那度胺 (Revlimid) 的情況以及您可能需要在業務上進行更多再投資以增加近期收入的潛力。會喜歡那裡的一些顏色。

Thanks, Evan. This is Giovanni. So first of all, the decision to execute the $4 billion ASR. And as you know, we had a $6 billion authorization outstanding is really driven by the great confidence we have in the future of the company. And importantly, the strong financial position we are in and the financial flexibility we have. So we remain in a position in which we are investing in the future of our company, and that's in terms of supporting a great pipeline that we have internally, but also continuing to be committed to business development as the central pillar of the capital allocation strategy.

謝謝，埃文。這是喬瓦尼。首先，決定執行 40 億美元的 ASR。如您所知，我們獲得了 60 億美元的未償授權，這實際上是因為我們對公司的未來充滿信心。重要的是，我們擁有強大的財務狀況和財務靈活性。因此，我們仍然致力於投資公司的未來，即支持我們內部擁有的龐大管道，同時也繼續致力於業務發展，將其作為資本配置戰略的核心支柱。

I think as David has mentioned many times, we are in a strong position and the capital allocation strategy of the company remains very balanced. But given the confidence we have in where we are and the future of the company, we made a decision to execute the ASR of $4 billion in Q3.

我認為正如大衛多次提到的，我們處於有利地位，公司的資本配置策略仍然非常平衡。但鑑於我們對自身現狀和公司未來充滿信心，我們決定在第三季度執行 40 億美元的 ASR。

Great. Thanks, Giovanni.

偉大的。謝謝，喬瓦尼。

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

我們的下一個問題來自美國銀行的傑夫·米查姆。

Just had a couple. So Giovanni, you went over the Revlimid dynamic in 2Q. Maybe just talk about the risks of recurrence of this co-pay assistance looking to 2024 for Revlimid or for Pomalyst. And then real quick on SOTYKTU. You guys with -- obviously, CVS and maybe some other payers removing [step edit], how should we think about kind of demand and share look into the second half of this year and going into '24?

剛剛有一對。 Giovanni，您回顧了第二季度 Revlimid 的動態。也許只是談談 Revlimid 或 Pomalyst 預計到 2024 年再次出現共同支付援助的風險。然後很快就可以上SOTYKTU了。你們——顯然，CVS 和其他一些付款人刪除了[步驟編輯]，我們應該如何考慮今年下半年和進入 24 年後的需求和份額？

Sure. Thank you, Geoff. Let me take the first question, and then we'll move to SOTYKTU. So we do expect the dynamics that I discussed for Revlimid and to a lesser extent, for Pomalyst to be limited to this year. And our confidence is based really on 2 factors. First of all, we are seeing that free drug applications to the BMS patient assistance foundations have been returning to normal levels. And second, remember there are significant changes to the Part D design next year, which will improve patient affordability, in fact patient contributions to the catastrophic phase are eliminated, and there is an expansion to the pool of patients that qualifies for [LIS].

當然。謝謝你，傑夫。讓我回答第一個問題，然後我們將轉向 SOTYKTU。因此，我們確實預計我所討論的 Revlimid 以及 Pomalyst 的動態將僅限於今年。我們的信心實際上基於兩個因素。首先，我們看到 BMS 患者援助基金會的免費藥物申請已恢復到正常水平。其次，請記住，明年 D 部分的設計將發生重大變化，這將提高患者的負擔能力，事實上，患者對災難性階段的貢獻被消除，並且符合 [LIS] 資格的患者群體有所擴大。

And so as a result of that, we see this one being very much of -- we expect this one to be very much an issue that has impacted this year for Pomalyst and lesser degree -- sorry, for Revlimid and a lesser extent, Pomalyst. Adam?

因此，我們認為這個問題在很大程度上——我們預計這個問題將成為今年對 Pomalyst 和較小程度產生影響的一個問題——抱歉，對於 Revlimid 和較小程度的 Pomalyst 。亞當？

Thanks for the question, Geoff. So we're very pleased with the SOTYKTU launch. So SOTYKTU oral market share is nearing 40% of the oral new demand market, and we're making great progress towards our goal, which we have stated is becoming the standard of care for oral products. We now have over 23,000 prescriptions since launch, and that means we've doubled the volume of SOTYKTU equivalent from the second quarter versus the first quarter. And as you mentioned, we're very, very pleased that we're able to secure and pull forward an access win, since CVS moves SOTYKTU preferred position in the middle of the month.

謝謝你的提問，傑夫。因此，我們對 SOTYKTU 的推出感到非常滿意。因此，SOTYKTU 口腔產品的市場份額接近口腔新需求市場的 40%，我們正在朝著我們的目標取得巨大進展，我們已經說過，這一目標正在成為口腔產品的護理標準。自推出以來，我們現在擁有超過 23,000 個處方，這意味著我們第二季度的 SOTYKTU 等效數量比第一季度增加了一倍。正如您所提到的，我們非常非常高興我們能夠確保並推進進入勝利，因為 CVS 在本月中旬移動了 SOTYKTU 的首選位置。

So that brings roughly 30 million lives or 15% of the total commercial lives covered in the United States. So if you have to put forward, we are -- expect in around 2 to 3 months to move patients from bridge to commercial drug. So we would expect a ramp for SOTYKTU commercial product in the back end of the year. We're also in continued negotiations with payers right now to work to secure improved commercial access in January. For all those reasons, I feel very good not only about our launch performance but our execution and continued growth in the second half of the year as well as into 2024.

因此，這帶來了大約 3000 萬人的生命，占美國商業生命總數的 15%。因此，如果您必須提出的話，我們預計在大約 2 到 3 個月內將患者從過渡藥物轉移到商業藥物。因此，我們預計 SOTYKTU 商業產品將在今年年底出現增長。我們目前還在繼續與付款人進行談判，以確保在一月份改善商業准入。出於所有這些原因，我不僅對我們的發布表現感到非常滿意，而且對我們下半年乃至 2024 年的執行力和持續增長感到非常滿意。

Thank you very much, Adam.

非常感謝你，亞當。

Our next question comes from Terence Flynn from Morgan Stanley.

我們的下一個問題來自摩根士丹利的特倫斯·弗林。

Great. Maybe 2 from me. I was just wondering if [Samit's] on, if you can talk about your confidence in Reblozyl securing a broad label in first-line MDS. I know there's been some discussion here post the ASCO presentation. And then I was wondering if there's any update on the Opdivo Hodgkin's lymphoma indication in the frontline setting for NCCN guideline updates.

偉大的。也許是我的2個。我只是想知道 [Samit] 是否參加，您是否可以談談您對 Reblozyl 在一線 MDS 中獲得廣泛標籤的信心。我知道在 ASCO 演講之後這裡已經進行了一些討論。然後我想知道 NCCN 指南更新的一線設置中 Opdivo 霍奇金淋巴瘤適應症是否有任何更新。

Thank you, Terence. So let me ask Samit to start and then Adam will cover the Opdivo question.

謝謝你，特倫斯。因此，讓我請 Samit 開始，然後 Adam 將討論 Opdivo 問題。

Thank you, Terence. Thank you for the question. For Reblozyl, of course, we cannot comment specifically on the label and discussions with the regulatory agencies. But I just want to remind again on how the study was conducted with the intent to treat principles applied to the study where all-comer patient population was engaged in the first-line setting, comparing versus ESA for RS-positive and RS-negative patients. And you saw the data in all-comer patient population, as well as in the subset analysis.

謝謝你，特倫斯。感謝你的提問。當然，對於 Reblozyl，我們無法具體評論標籤以及與監管機構的討論。但我只是想再次提醒一下，這項研究是如何進行的，其目的是治療適用於該研究的原則，其中所有患者群體都參與了一線環境，將 RS 陽性和 RS 陰性患者與 ESA 進行比較。您看到了所有患者群體中的數據以及子集分析中的數據。

And we repeatedly certainly tried to convey that if you think about the efficacy of the drug, what is most important for the patients is to stay off of transfusion. And in all subsets, you see that consistently across the board. The patients who benefit as well as stay off of transfusion for a long duration. So we are confident in our data. But of course, we will continue to wait for -- when the label is finalized and is able to share -- and we are able to share that. But Adam, do you want to add something?

當然，我們一再試圖傳達這樣的信息：如果考慮到藥物的功效，對患者來說最重要的是不要輸血。在所有子集中，您都會看到這一點。患者受益並長期停止輸血。所以我們對我們的數據充滿信心。但當然，我們將繼續等待——當標籤最終確定並能夠分享時——我們能夠分享這一點。但是亞當，你想補充點什麼嗎？

Sure. Thanks, Samit. And so we're (inaudible) in about what we're seeing for [Reblozyl] for the quarter. The growth is coming both from the U.S. and internationally as it relates to the COMMANDS approval. Remember, this is certainly an important launch for us. The PDUFA is in 4 weeks, and our U.S. team is launch-ready. And so what we're hearing from physicians, both ASCO, both EHA, physicians tell us they want to use Reblozyl regardless of RS status because of durability and the opportunity for transfusion-independent. So taken together, I think we're well-positioned to be really the new standard of care in the first-line setting.

當然。謝謝，薩米特。因此，我們（聽不清）了解了 [Reblozyl] 本季度的情況。這一增長來自美國和國際，因為這與命令的批准有關。請記住，這對我們來說無疑是一次重要的發布。 PDUFA 將在 4 週後發布，我們的美國團隊已做好發布準備。因此，我們從 ASCO 和 EHA 醫生那裡聽到的消息告訴我們，無論 RS 狀態如何，他們都希望使用 Reblozyl，因為其耐用性和不需輸血的機會。綜上所述，我認為我們完全有能力成為一線護理的新標準。

So as it relates to the second question, which is Opdivo in CHL. We also were very pleased with the data presented at ASCO, where Opdivo demonstrated superiority versus (inaudible) in a head-to-head study. Similarly, we've heard from oncologists that this data is practice-changing. And as a reminder, this is a confirmatory study or our current indication under accelerated approval, and we will work with [SWAG] on next steps to analyze the full dataset, and we also look forward to discussing this with regulators. I would also expect to see NCCN guideline adoption over the coming weeks to months as well.

這涉及到第二個問題，即 CHL 中的 Opdivo。我們對 ASCO 上提供的數據也非常滿意，在一項頭對頭研究中，Opdivo 表現出了相對於（聽不清）的優越性。同樣，我們從腫瘤學家那裡得知，這些數據正在改變實踐。提醒一下，這是一項驗證性研究或我們當前正在加速批准的適應症，我們將與 [SWAG] 合作開展後續步驟來分析完整的數據集，我們也期待與監管機構討論此事。我還希望看到 NCCN 指南在未來幾周到幾個月內得到採用。

Thanks very much, Adam.

非常感謝，亞當。

Our next question comes from Chris Schott from JPMorgan.

我們的下一個問題來自摩根大通的克里斯·肖特。

Just 2 from me. Maybe first on the sales guidance, just so I'm clear, did anything else change in your revenue outlook beyond this update for Revlimid and Pomalyst? Or is that really the only change in the overall top line numbers? And then my second question was just on Breyanzi and Abecma. I'm just trying to get a sense of how to think about the capacity ramp from here. You've obviously had a nice kind of build in the first half of the year, but it seems like the guidance is pointing to sales kind of flattening out in the second half. So I guess when can we think about the next kind of leg up for capacity for these products? And how much of a ramp can we think about as we look out to 2024?

就我2個。也許首先是銷售指導，我想清楚的是，除了 Revlimid 和 Pomalyst 的這次更新之外，您的收入前景還有其他變化嗎？或者這真的是總體營收數字的​​唯一變化嗎？我的第二個問題是關於 Breyanzi 和 Abecma。我只是想了解如何從這裡考慮產能提升。顯然，上半年的銷售情況不錯，但指導似乎表明下半年的銷售將趨於平緩。所以我想我們什麼時候可以考慮進一步提高這些產品的產能？展望 2024 年，我們可以考慮多大程度的增長？

Thank you, Chris. David and Adam.

謝謝你，克里斯。大衛和亞當。

Thanks, Chris. The only change to our guidance was related to the Revlimid and Pomalyst dynamic that we discussed before.

謝謝，克里斯。我們指導的唯一變化與我們之前討論過的 Revlimid 和 Pomalyst 動態有關。

Yes. So Chris, I'll take the second part of your question. We're (inaudible) seeing across our cell therapy franchise. This year, we made very good progress on increased capacity for both Abecma and Breyanzi. And so when you look at our approach to the market, number one, our focus is rapidly expanding our footprint both in the U.S. and internationally based on our increase in supply. When you look at the approach we're taking overall for CAR T manufacturing, there are really 2 components to cell therapy and drug product and vector.

是的。克里斯，我將回答你問題的第二部分。我們（聽不清）看到了我們的細胞治療專營權。今年，我們在增加 Abecma 和 Breyanzi 的產能方面取得了非常好的進展。因此，當你審視我們的市場策略時，第一，我們的重點是根據供應的增加，迅速擴大我們在美國和國際上的足跡。當您觀察我們總體上採用的 CAR T 製造方法時，您會發現細胞療法、藥物產品和載體實際上由兩個組成部分組成。

So for drug product, we have increased capacity with successfully executed ramps at both our existing sites for Breyanzi and Abecma, and additional ramps planned for each product in the back end of 2023. We're building new state-of-the-art facilities, as we talked about, in Devens, Massachusetts, online this year, as well as Leiden in the Netherlands, which will come on board in 2025 to further increase and accelerate capacity. The second area is really around better, and we continue to both internalize and externalized vector in our fastest (inaudible) increase capacity of our current vectors to partner with existing third-party manufacturers.

因此，對於藥品，我們在 Breyanzi 和 Abecma 的現有工廠成功實施了坡道，提高了產能，併計劃在 2023 年底為每種產品增加坡道。我們正在建設新的最先進的設施正如我們談到的，今年在馬薩諸塞州德文斯上線，以及荷蘭萊頓將於 2025 年上線，以進一步增加和加速產能。第二個領域確實更好，我們繼續以最快（聽不見）的方式增加內部化和外部化向量，以最快（聽不清）增加我們當前向量的容量，以便與現有的第三方製造商合作。

So you've heard about our new vector manufacturing plant in Libertyville, Illinois. It's part of our dual sourcing strategy to internalize vector, which complements our existing partnerships with external third parties. And we're accelerating our transition to next-gen vector technologies as well. So taken together, we're making very good progress in increasing our capacity on both Abecma and Breyanzi.

您已經聽說過我們位於伊利諾伊州利伯蒂維爾的新載體製造工廠。這是我們內部化矢量雙重採購戰略的一部分，它補充了我們與外部第三方的現有合作夥伴關係。我們也在加速向下一代矢量技術的過渡。總而言之，我們在提高 Abecma 和 Breyanzi 的產能方面取得了非常好的進展。

Chris, the only thing I would add is just that the manufacturing investments that Adam alluded to are part of a broader strategy that we have that I think is going to be important for us as we think about this platform more generally. And that is -- you've heard us talk about in the past and we'll talk again about at the R&D Day in September, we've obviously got a very exciting portfolio of cell therapy assets, notably GPRC5D as well as NEX T CD19. And so these investments would be critical for those as well.

克里斯，我唯一要補充的是，亞當提到的製造業投資是我們更廣泛戰略的一部分，我認為當我們更廣泛地考慮這個平台時，這對我們來說非常重要。那就是——您過去曾聽我們談論過，我們將在 9 月份的研發日再次談論，我們顯然擁有非常令人興奮的細胞治療資產組合，特別是 GPRC5D 以及 NEX T CD19。因此，這些投資對於這些人來說也至關重要。

Thanks very much, Chris.

非常感謝，克里斯。

Our next question comes from Seamus Fernandez from Guggenheim Securities.

我們的下一個問題來自古根海姆證券公司的謝默斯·費爾南德斯。

So just a couple here. First, in terms of the pipeline assets, you guys are focusing in on LPA1. Just wanted to get a sense for the pace of development for that program? And what you see as a market opportunity for -- in IPF and PPF specifically? And then separately on the IRA, just hoping that you could give us a little bit of your sense of the pushes and pulls. We've had some conversations recently where experts, expert legal consultants would suggest that there's potential for a preliminary injunction to be issued because of the pressure points around the fifth amendment. Would be very interested to hear your thoughts along those lines around the IRA, as well as some of the positive influences of IRA in 2024 and 2025 that could positively impact your revenue lines.

所以這裡只有一對夫婦。首先，就管道資產而言，你們關注的是LPA1。只是想了解該程序的開發速度嗎？您認為 IPF 和 PPF 方面的市場機會是什麼？然後分別討論愛爾蘭共和軍，希望你能給我們一點你對推拉的感覺。我們最近進行了一些對話，專家、專家法律顧問建議，由於第五修正案的壓力點，有可能發布初步禁令。我很想听聽您對 IRA 的看法，以及 IRA 在 2024 年和 2025 年可能對您的收入產生積極影響的一些積極影響。

Thanks, Seamus. Let me just start maybe with a short comment on IRA, and then Samit and Adam will answer your question on LPA1, which is a really exciting program. So on IRA, I'm not going to comment on litigation and I can't really comment on what may happen on that front. I think we've been very clear with our concerns with IRA as it relates to the negative impact on innovation and in particular cancer care in the future, but also with the concerns we have with respect to the process, of course, and the mechanisms for price setting.

謝謝，西莫。讓我先對 IRA 做一個簡短的評論，然後 Samit 和 Adam 將回答您關於 LPA1 的問題，這是一個非常令人興奮的計劃。因此，關於 IRA，我不會對訴訟發表評論，也不能真正評論這方面可能發生的事情。我認為我們對 IRA 的擔憂非常明確，因為它關係到對創新、特別是未來癌症護理的負面影響，當然，我們也對流程和機制感到擔憂用於定價。

Now with respect to the things that are in IRA, of course, as we've always said, there are positive elements to IRA, which include the improvements we see in affordability for patients. In fact, I mentioned earlier that, obviously, the fact that next year patients will no longer contribute to the catastrophic phase and there is an expansion of the definition for LIS eligibility. These are good examples of things that go very much in the right direction. And of course, the impact parts of our business, including Eliquis, as an example. Samit?

現在就 IRA 中的內容而言，當然，正如我們一直所說的，IRA 有積極的因素，其中包括我們看到患者負擔能力的改善。事實上，我之前提到過，很明顯，明年患者將不再為災難性階段做出貢獻，並且 LIS 資格的定義有所擴大。這些都是事情朝著正確方向發展的好例子。當然，還有我們業務的影響部分，例如 Eliquis。薩米特？

Thank you, Giovanni, and thanks for the question, Seamus. So LPA1, if you think about IPF and PPF, they both are conditions which have a very high unmet medical need. To date, there are only 2 drugs approved for IPF and only 1 approved for PPF, so -- and both of them have their own safety liability, which does not allow patients to continue on treatment for a very long duration. We have now shown in 3 different studies, the first one with the first generation of LPA1 and the other 2 studies that recently completed.

謝謝喬瓦尼，也謝謝謝莫斯的提問。所以 LPA1，如果你考慮 IPF 和 PPF，它們都是具有非常高的未滿足醫療需求的疾病。迄今為止，只有 2 種藥物被批准用於 IPF，只有 1 種藥物被批准用於 PPF，因此，這兩種藥物都有各自的安全責任，不允許患者繼續長期治療。我們現在已經展示了 3 項不同的研究，第一項研究涉及第一代 LPA1，另外兩項研究最近完成。

We've shown the efficacy of the oral drug, our LPA1 inhibitor in improving the outcomes for these patients in terms of decreasing the reduction of FVC. You saw the data for LPA1 and IPF, where we showed an improvement in that -- in the FVC, both in patient population which was treated without any background therapy, as well as in patients who were on background therapy. Later this year, we will be able to share the data at a medical conference for [PPF] as well. Both of these datasets are giving us confidence that we will be launching 2 Phase III trials starting later this year or very early next year for IPF and PPF to be able to bring this medicine to patients in the short-term. But Adam, do want add about...

我們已經證明了口服藥物（我們的 LPA1 抑製劑）在減少 FVC 減少方面改善這些患者的預後的功效。您看到了 LPA1 和 IPF 的數據，我們在 FVC 方面顯示了改善，無論是在沒有任何背景治療的患者群體中，還是在接受背景治療的患者中。今年晚些時候，我們還將能夠在 [PPF] 的醫學會議上分享數據。這兩個數據集都讓我們充滿信心，我們將在今年晚些時候或明年初開始針對 IPF 和 PPF 啟動 2 項 III 期試驗，以便能夠在短期內將這種藥物帶給患者。但是亞當，確實想補充一下......

Yes, Samit. Thanks. From a commercial standpoint, we're very encouraged by LPA1 asset. As Samit alluded to, it's a very high unmet need in IPF and PPF. And the prognosis for these diseases are not too dissimilar to some metastatic cancer diagnoses. And so we generated, as I mentioned, very encouraging [efficacy] and safety data. There was no GI toxin with the current treatments, no liver toxicity that we saw in the early phase. And this gives us confidence, as Samit mentioned, to move into Phase III.

是的，薩米特。謝謝。從商業角度來看，我們對 LPA1 資產感到非常鼓舞。正如 Samit 提到的，IPF 和 PPF 的未滿足需求非常高。這些疾病的預後與某些轉移性癌症的診斷並沒有太大不同。因此，正如我提到的，我們生成了非常令人鼓舞的[功效]和安全數據。目前的治療沒有胃腸道毒素，也沒有我們在早期階段看到的肝臟毒性。正如薩米特提到的，這給了我們進入第三階段的信心。

Now the current products have significant limitations in efficacy and toxicity. And I think from a commercial standpoint, awareness and better diagnosis tools are going to really help accelerate the diagnosis [range] , which are pretty low today. They range around 30% to 40%. And we think when we bring our LPA1 to market, we'll be able to accelerate that significantly and make a significant impact in patients with these serious diseases.

目前的產品在功效和毒性方面都存在很大的局限性。我認為從商業角度來看，意識和更好的診斷工具將真正有助於加速診斷[範圍]，而今天的診斷範圍相當低。它們的比例約為 30% 至 40%。我們認為，當我們將 LPA1 推向市場時，我們將能夠顯著加速這一進程，並對患有這些嚴重疾病的患者產生重大影響。

Thanks, Adam.

謝謝，亞當。

Our next question comes from Carter Gould from Barclays.

我們的下一個問題來自巴克萊銀行的卡特·古爾德。

Two from me. I guess, first, just hoping to get a little bit more color on some of the trends you're seeing with [EYLEA]. I mean, basically, your confidence on reacceleration in the back half of the year given the sequential decline in U.S. and flat ex U.S. And then just quickly on Opdualag, you talked about potentially becoming standard of care in melanoma. Can you talk a little bit about -- maybe a little more color on kind of what's a reasonable kind of market share assumption? Or how -- what really would that need to be in terms of market share or some further color on that front?

我的兩個。我想，首先，只是希望通過 [EYLEA] 對您所看到的一些趨勢有更多的了解。我的意思是，基本上，鑑於美國的連續下降和美國以外的持平，您對下半年重新加速充滿信心。然後很快在 Opdualag 上，您談到了可能成為黑色素瘤治療標準的可能性。您能否談談——也許對什麼是合理的市場份額假設有更多的了解？或者如何——就市場份額或這方面的一些進一步的色彩而言，真正需要什麼？

Sure. Adam?

當然。亞當？

Thank you, Carter. To start, let me just say, we're very pleased with what we're seeing across our cell therapy franchise. Now for Abecma, as David mentioned, year-on-year we grew approximately [50%]. There are a few factors that impacted the second quarter for Abecma. The quarter-on-quarter decline was driven mainly by pricing dynamics in Germany. Second, there was a planned impact due to manufacturing maintenance happened in June in anticipation of our KarMMa-3 approval, which we expect in the back end of the year, we would also anticipate a significant increase in volume in the fourth quarter.

謝謝你，卡特。首先，我要說的是，我們對我們在細胞治療系列中所看到的結果感到非常滿意。現在，對於 Abecma，正如 David 提到的，我們同比增長了大約 [50%]。有幾個因素影響了 Abecma 第二季度的業績。環比下降主要是由德國的定價動態造成的。其次，由於預計我們的 KarMMa-3 會在今年年底獲得批准，因此 6 月份發生了製造維護，因此產生了計劃內的影響，我們預計第四季度的銷量也會大幅增加。

And thirdly, we anticipate an increase in the use of other BCMA agents in the U.S. And we know this is a competitive market. But it's a market that we know extremely well, and we're very confident in our ability to compete in both myeloma with this important product, for Abecma. I think most importantly, we continue to see and hear from physicians about favorable perceptions for Abecma based on our durable responses in a real-world setting as well as high manufacturing success rates now that are north of 90%.

第三，我們預計美國其他 BCMA 藥物的使用將會增加，而且我們知道這是一個競爭激烈的市場。但我們對這個市場非常了解，我們對 Abecma 的這一重要產品在骨髓瘤領域的競爭能力非常有信心。我認為最重要的是，我們不斷看到和聽到醫生對 Abecma 的良好看法，這是基於我們在現實環境中的持久反應以及目前超過 90% 的高製造成功率。

So taken together, we do remain very confident about Abecma's outlook in the second half of 2023 and beyond. The second question was around Opdualag. And so for Opdualag, as you heard from David, Opdualag is rapidly becoming the standard of care in the U.S. We're continuing to see strong growth in sales our share in first-line metastatic melanoma is approaching 25%. And our share is coming both from PD-1 monotherapy and from Opdivo-Yervoy combination. But about 2/3 of that share is or some PD-1 monotherapy, roughly 50-50 from Opdivo and KEYTRUDA.

綜上所述，我們對 Abecma 2023 年下半年及以後的前景仍然充滿信心。第二個問題是關於 Opdualag 的。因此，對於 Opdualag，正如您從 David 那裡聽到的那樣，Opdualag 正在迅速成為美國的護理標準。我們繼續看到銷售額的強勁增長，我們在一線轉移性黑色素瘤中的份額接近 25%。我們的份額來自 PD-1 單一療法和 Opdivo-Yervoy 聯合療法。但其中大約 2/3 是 PD-1 單一療法，大約 50-50 來自 Opdivo 和 KEYTRUDA。

As we talked about last quarter, NCCN updated their guidelines and changed Opdualag from Category 2A to category 1 in BRAF mutant patient population, and it removed BRAF/MEK inhibitors as a preferred treatment in the first-line setting. So as a result, we're seeing a really nice inflection in the BRAF mutant patient population for both Opdualag and for Opdivo-Yervoy, and that's where we're continuing to focus our efforts on that segment. So in fact, when I think about the total BMS share in the overall metastatic melanoma market, our share -- if you look at Opdualag, Opdivo-Yervoy and Opdivo monotherapy, our share is now greater than 55%. So I'm very proud of our continued leadership in metastatic melanoma.

正如我們上季度討論的那樣，NCCN 更新了指南，將 BRAF 突變患者群體中的 Opdualag 從 2A 類更改為 1 類，並取消了 BRAF/MEK 抑製劑作為一線治療的首選治療方法。因此，我們在 Opdualag 和 Opdivo-Yervoy 的 BRAF 突變患者群體中看到了非常好的變化，這就是我們繼續將精力集中在該細分市場的地方。事實上，當我考慮 BMS 在整個轉移性黑色素瘤市場中的總份額時，我們的份額——如果你看看 Opdualag、Opdivo-Yervoy 和 Opdivo 單藥療法，我們的份額現在超過 55%。因此，我對我們在轉移性黑色素瘤領域的持續領導地位感到非常自豪。

And just to add to what Adam has just talked about Opdualag, there is obviously a large program behind the approved indication in metastatic melanoma. We have the adjuvant study in melanoma that will read out as the events come through, as well as the Phase III study in colorectal cancer MSS that will also be -- which is an event-driven overall survival primary endpoint study that will read out over 2024, 2025.

補充一下 Adam 剛剛談到的 Opdualag，在轉移性黑色素瘤的批准適應症背後顯然有一個大型項目。我們有黑色素瘤的輔助研究，將在事件發生時讀出，以及結直腸癌 MSS 的 III 期研究，這是一項事件驅動的總體生存主要終點研究，將在事件發生後讀出2024 年、2025 年。

And then, of course, behind that, we're looking forward to seeing the data early next year for non-small cell lung cancer as well as for hepatocellular carcinoma in the first and the second line in 2024. So there is a large program behind the melanoma metastatic data.

當然，在這背後，我們期待明年初看到非小細胞肺癌的數據，以及 2024 年第一線和第二線肝細胞癌的數據。所以有一個大型計劃黑色素瘤轉移數據的背後。

Thanks, Samit.

謝謝，薩米特。

Our next question comes from Tim Anderson from Wolfe Research.

我們的下一個問題來自沃爾夫研究中心的蒂姆·安德森。

I wanted to go back to IRA, and it's not on the drug price renegotiation piece, it's on the Part D redesign that kicks into 2025. So you guys have talked about positive being less out-of-pocket spending, but there's a negative to contemplate, too, which is manufacturers having to pick up a healthy portion of catastrophic spending that has not been part of the equation before. So on a net basis, when you're thinking about Part D redesign starting next year, is that going to be a net drag to earnings? It seems to me like it could be. So that's the first question.

我想回到 IRA，這不是關於藥品價格重新談判的問題，而是關於從 2025 年開始的 D 部分重新設計。所以你們談到了減少自付費用的積極因素，但也有消極因素還要考慮一下，製造商必須承擔災難性支出中的一部分，而這在以前是不存在的。因此，從淨值來看，當您考慮從明年開始重新設計 D 部分時，這是否會對盈利產生淨拖累？在我看來可能是這樣。這是第一個問題。

And then second question, is on Opdivo. The press release mentions lower average net selling prices, I think, in Europe in Q2 and [Merck] has forewarned something similar for a while now. I'm wondering what's driving this?

第二個問題是關於 Opdivo。我認為，新聞稿提到歐洲第二季度的平均淨售價較低，並且[默克]已經預先警告了類似的情況。我想知道是什麼推動了這一點？

Chris.

克里斯。

Maybe I'll start and then I'll turn it over to Adam to talk about the Opdivo piece. Thanks for the question, Tim. With respect to IRA, I think this is, in some ways, very consistent with the way we've been describing IRA's impact generally, which is that when you look at the changes in Part D, it's going to be very much product specific. And so there will be pushes and pulls depending upon which product you're talking about. And so it's very difficult to make a blanket statement that it's a negative or a positive.

也許我會開始，然後我會把它交給 Adam 來談論 Opdivo 的部分。謝謝你的提問，蒂姆。關於 IRA，我認為這在某些方面與我們一般描述 IRA 影響的方式非常一致，即當您查看 D 部分中的更改時，它將非常針對特定產品。因此，根據您所談論的產品，將會有推力和拉力。因此，很難做出一個籠統的聲明，說這是消極的還是積極的。

I think you really do have to get into the specifics and understand the details as to how it will impact a given product, just given the nature of the patients who are being treated by that product as well as the concomitant medicines that they're on. So that's very much how we think about the Part D redesign. Adam, do you want to pick up on the Opdivo question?

我認為你確實必須深入了解具體細節並了解它將如何影響特定產品的細節，只要考慮到正在接受該產品治療的患者的性質以及他們所服用的伴隨藥物。這就是我們對 D 部分重新設計的看法。 Adam，您想了解 Opdivo 的問題嗎？

Yes. Tim, thanks for the question. As it relates to Opdivo internationally, what we're seeing is continued strong growth in our international market. In fact, when you look at year-over-year or the quarter, we grew 10% for Opdivo internationally. And that's really due to the continued growth of our core business in first-line lung, in gastric, and we're just starting to unlock some of our new indications. We're very pleased to see our approval of [CheckMate -816] in Europe. And when I think about the kind of the decline of price in Europe, that any time you get a new indication in many of our markets, you start to take slight price decreases. But the volume that we see for Opdivo as we add these tumors and get reimbursement, we look to continue to increase our sales and our volume will certainly offset any price decline.

是的。蒂姆，謝謝你的提問。由於 Opdivo 在國際上的應用，我們看到的是我們的國際市場持續強勁增長。事實上，當你觀察同比或本季度時，我們的 Opdivo 在國際上增長了 10%。這實際上是由於我們在一線肺、胃方面的核心業務的持續增長，而且我們剛剛開始釋放一些新的適應症。我們很高興看到 [CheckMate -816] 在歐洲獲得批准。當我想到歐洲價格的下跌時，每當我們的許多市場出現新的跡象時，您就會開始出現價格小幅下跌。但是，當我們添加這些腫瘤並獲得報銷時，我們看到 Opdivo 的銷量，我們希望繼續增加我們的銷售額，我們的銷量肯定會抵消任何價格下降。

Yes. And just -- Tim, just to add on what Chris mentioned before on IRA. We have discussed before that we don't see a meaningful impact for us until '26. So the dynamics that Chris described don't meaningfully impact our P&L and our outlook in '24 and '25.

是的。蒂姆，補充一下克里斯之前在 IRA 中提到的內容。我們之前討論過，直到 26 年前我們才看到對我們有意義的影響。因此，克里斯描述的動態不會對我們的損益以及 24 年和 25 年的前景產生有意義的影響。

Thanks, Giovanni.

謝謝，喬瓦尼。

Our next question comes from Andrew Baum from Citi.

我們的下一個問題來自花旗銀行的安德魯鮑姆。

It's Ana Hutchinson from Citi on behalf of Andrew. Question please on Opdivo, can you talk to the 2% sales growth in the U.S. and give a bit more context there? You mentioned customer buying patterns, can you elaborate on the dynamics? And are there any other factors you would flag competition, (inaudible) concerns or anything like that?

我是來自花旗銀行的安娜·哈欽森 (Ana Hutchinson)，代表安德魯 (Andrew)。關於 Opdivo 的問題，您能談談美國 2% 的銷售額增長並提供更多背景信息嗎？您提到了客戶購買模式，您能詳細說明一下其動態嗎？您是否還有其他因素需要標記競爭、（聽不清）擔憂或類似因素？

Yes. Emily, thanks for the question. So we're pleased with what we saw with Opdivo through the first half of the year, and we anticipate continued growth through to the back end of the year. In fact, Opdivo grew 11% overall year-to-date. And so what we see internationally, we're also seeing our growth coming from same core tumors. First-line lung. Our share is now approximately. On gastric indication first line, where our share is approximately 50%, and across our early adjuvant indications.

是的。艾米麗，謝謝你的提問。因此，我們對今年上半年 Opdivo 的表現感到滿意，並預計到今年年底將繼續增長。事實上，Opdivo 今年迄今整體增長了 11%。因此，我們在國際上看到，我們也看到我們的增長來自相同的核心腫瘤。肺一線。我們現在的份額大約是。在胃適應症一線，我們的份額約為 50%，以及我們的早期輔助適應症。

As you noted, sequentially, in the second quarter, the demand growth in the U.S. from our core business was offset by impact from unfavorable customer buying patterns. And so we expect that to normalize and continue to grow based on the strength across multiple tumors. And we continue to lead all competitors in every tumor in the U.S. that were indicated in, with the exception of first-line lung, where we're making good progress.

正如您所指出的，第二季度，我們核心業務在美國的需求增長被不利的客戶購買模式的影響所抵消。因此，我們預計這種情況會根據多個腫瘤的強度而正常化並繼續增長。我們在美國的每一種腫瘤治療中都繼續領先於所有競爭對手，但一線肺癌除外，我們在這方面取得了良好的進展。

We also have a number of significant readouts in the short term. So we've got some nice catalysts including our stage 2 melanoma indication, which is -- has a PDUFA date of October of this year. And you also read our press release in first-line cis-eligible bladder, particularly 901, and that's really exciting in multiple I-O failures there. So we expect that to be a nice catalyst next year along with pending readouts next year in [CheckMate -77T], and CheckMate -73L, among several others. So for those reasons, we remain very confident in Opdivo's ability to grow in 2023.

短期內我們還有一些重要的數據。因此，我們有一些很好的催化劑，包括我們的 2 期黑色素瘤適應症，即 PDUFA 日期為今年 10 月。您還閱讀了我們關於一線順式膀胱的新聞稿，特別是 901，這在多次 I-O 失敗中確實令人興奮。因此，我們預計這將成為明年的一個很好的催化劑，以及明年 [CheckMate -77T] 和 CheckMate -73L 等的待定讀數。因此，出於這些原因，我們對 Opdivo 在 2023 年的增長能力仍然非常有信心。

Thanks, Adam.

謝謝，亞當。

Our next question comes from Steve Scala from TD Cowen.

我們的下一個問題來自 TD Cowen 的 Steve Scala。

I'd like to ask a question about Revlimid. So you mentioned that you started to see the weakness at the end of Q1, yet the guidance was reiterated at the end of April, presumably because you thought it was temporary. So what was the error in that assumption? You noted the free drug program is expected to return to normal levels in future years. Why then is the expected decline on an annual basis expected to be less than before? I know that you said government support could be an offset, but that seems like a dynamic in which we should not have high confidence. And just to be clear, generic competitors have nothing to do whatsoever with this cut today. And then the second question is Takeda noted weakness in the U.S. GI market this morning, what -- are you seeing this? And if yes, to what do you attribute it?

我想問一個關於 Revlimid 的問題。所以你提到你在第一季度末開始看到疲軟，但在四月底重申了指導，大概是因為你認為這是暫時的。那麼這個假設的錯誤是什麼？您指出免費藥物計劃預計將在未來幾年恢復到正常水平。那麼為什麼預期的年度降幅會比以前小呢？我知道你說政府的支持可能會起到抵消作用，但這似乎是一種我們不應該抱有太大信心的動態。需要明確的是，仿製藥競爭對手與今天的此次降價沒有任何關係。第二個問題是武田今天早上註意到美國地理標誌市場疲軟，您看到了嗎？如果是，您將其歸因於什麼？

Thank you, Steve. Let me -- I know we've discussed a lot on Revlimid in our prepared remarks. And I just want to go back to explaining the dynamics at play here. So we started to see some softness in Revlimid revenue at the end of Q1, and obviously we needed to understand why. I think it's important to remember that there were a number of dynamics happening at the same time. So as you know, the most recent increase in generic volumes had entered in March, and we have seen that drive significant variability in the past.

謝謝你，史蒂夫。讓我——我知道我們在準備好的發言中已經討論了很多關於 Revlimid 的問題。我只想回過頭來解釋一下這裡的動態。因此，我們在第一季度末開始看到來那度胺 (Revlimid) 收入出現一些疲軟，顯然我們需要了解原因。我認為重要的是要記住，有許多動態同時發生。如您所知，仿製藥銷量的最近一次增長是在三月份，我們已經看到這在過去推動了顯著的變化。

At the same time, we saw an increase in the number of patients that were receiving free drug from the BMS Patient Assistance Foundation, which also started in Q1. Of course, we looked into this dynamic and skewed to progress. The number of patients on free drug started to increase, continue to increase eventually reaching significantly higher levels than we had seen historically. And also the impact on Revlimid and Pomalyst revenue accelerated during the course of Q2. So we have been looking at these trends.

與此同時，我們看到從 BMS 患者援助基金會獲得免費藥物的患者數量有所增加，該項目也在第一季度開始。當然，我們研究了這一動態並傾向於取得進展。接受免費藥物的患者數量開始增加，並繼續增加，最終達到顯著高於我們歷史上看到的水平。第二季度對 Revlimid 和 Pomalyst 收入的影響也加速了。所以我們一直在關注這些趨勢。

And one of the things that is important to consider here is that once the BMS Patient Assistance Foundation provides free drug to patients consistent with HHS guidance, we provide that free drug for the totality of this. And so what we looked at was not only the impact on the quarter, but also the impact on the full year. And today, we are in a position to assess those impacts, and that's why we are in a position to give you a clearer picture of what happened beginning at the end of Q1 and most importantly in Q2.

這裡需要考慮的重要事情之一是，一旦 BMS 患者援助基金會按照 HHS 指導向患者提供免費藥物，我們就會提供全部免費藥物。因此，我們不僅關注對季度的影響，還關注對全年的影響。今天，我們能夠評估這些影響，這就是為什麼我們能夠讓您更清楚地了解第一季度末開始，最重要的是第二季度發生的情況。

You asked the question -- so the generic dynamics that we've discussed for a while, which really accounts for month-to-month and quarter-to-quarter variability, are not a factor in what we are -- we've disclosed today. But obviously, they were at play as we were looking at the development of Revlimid revenue during the second quarter. You asked the question as to why we are expecting now the step-down for Revlimid to be lower next year. And a couple of things that I'd like to say again. So first of all, as I mentioned earlier, we don't expect these dynamics to continue next year, because we are seeing that the number of patients applying for free product for -- from the BMS Patient Assistance Foundation is returning to normal.

你問了這個問題——所以我們已經討論了一段時間的一般動態，它真正解釋了月與月和季度與季度的變化，並不是我們的一個因素——我們已經披露了今天。但顯然，當我們觀察第二季度 Revlimid 收入的發展時，它們正在發揮作用。您問到為什麼我們現在預計來那度胺明年的降幅會更低。還有幾件事我想再說一遍。首先，正如我之前提到的，我們預計這些動態明年不會持續，因為我們看到從 BMS 患者援助基金會申請免費產品的患者數量正在恢復正常。

And importantly, because of the Part D redesign dynamics that I covered before. And so if you think about it, if you have a lower base coming out of 2023, given that we don't really see a change in the generic erosion assumptions that we have made before, now the step-down is lower and we've estimated that to be $1.5 billion in '24 and approximately $2 billion in 2025. So that's the number of dynamics at play here. And second question for Adam.

重要的是，由於我之前介紹過的 D 部分重新設計動態。因此，如果您考慮一下，如果 2023 年之後的基數較低，鑑於我們並沒有真正看到我們之前所做的一般侵蝕假設發生變化，那麼現在的降幅較低，我們'我們估計 24 年這一數字將達到 15 億美元，到 2025 年將達到約 20 億美元。這就是這裡發揮作用的動態數量。亞當的第二個問題。

The second question that you asked, Steve, was around the -- what we're seeing in the GI marketplace. And so overall, we're seeing for Zeposia is really strong growth, 28% quarter-over-quarter growth as well as approximately 50% growth versus same time last year. When we look at the GI market, we continue to see acceleration of demand for Zeposia in UC. What we're hearing from thought leaders is that they continue to emphasize the benefit of using Zeposia in the first-line setting. In fact, we look at our business shift now, about 60% of our business for Zeposia is in the first-line use.

史蒂夫，你問的第二個問題是關於我們在地理標誌市場上看到的情況。總的來說，我們看到 Zeposia 的增長非常強勁，環比增長 28%，與去年同期相比增長約 50%。當我們觀察地理標誌市場時，我們繼續看到 UC 中對 Zeposia 的需求加速增長。我們從思想領袖那裡聽到的是，他們繼續強調在一線環境中使用 Zeposia 的好處。事實上，我們現在看我們的業務轉移，我們Zeposia的業務大約有60%是在一線使用。

And we're continuing to make good progress on the access front, where now 40% of lives have either 0 or 1 step at it, and we're working to continue to improve that in 2024. So for those reasons, we're pleased with our growth in the GI market with Zeposia. We're also seeing strong performance in MS, when -- our share of at an all-time high. And so we expect continued growth for Zeposia in the back end of this year and certainly into '24 as well.

我們繼續在接入方面取得良好進展，現在 40% 的人在這方面邁出了 0 或 1 步，我們正在努力在 2024 年繼續改進這一點。因此，出於這些原因，我們我們對 Zeposia 在地理標誌市場的增長感到滿意。我們還看到 MS 的強勁表​​現，當時我們的份額達到了歷史最高水平。因此，我們預計 Zeposia 在今年年底將持續增長，當然到 24 世紀也是如此。

Thanks, Adam. Let's just try to squeeze a couple more in here, if you don't mind me, closing to the next one, please, Jamie.

謝謝，亞當。如果你不介意的話，讓我們試著再擠幾個在這裡，請結束下一個，傑米。

Our next question comes from Matt Phipps from William Blair.

我們的下一個問題來自威廉·布萊爾的馬特·菲普斯。

First, are you still confident in the roughly $4 billion in new product growth guidance for this year from the new product portfolio? It seems about 50% in the second half versus the first half, so what might drive that, especially if cell therapies are flat? And then Samit, you mentioned seeing the Opdualag data in non-small cell next year. But I did notice on Slide 7, the first line non-small cell for Opdualag as a key milestone has officially been added as some of the long-term opportunity. So just confirmed you haven't seen that data in-house yet to make that addition?

首先，您對今年新產品組合約 40 億美元的新產品增長指導仍然有信心嗎？與上半年相比，下半年的比例似乎約為 50%，那麼什麼可能推動這一趨勢，尤其是在細胞療法表現平平的情況下？然後 Samit，您提到明年會在非小蜂窩中看到 Opdualag 數據。但我確實在幻燈片 7 上註意到，Opdualag 的第一條線非小型蜂窩基站作為一個關鍵里程碑已被正式添加為一些長期機會。所以只是確認您還沒有看到內部數據來進行添加？

Maybe I'll start, Matt, and then I'll turn it over to Adam before going to Samit. So as I mentioned earlier, Matt, we continue to be confident in the progress of this portfolio. We remain on track to roughly double revenue for the portfolio this year. And by extension, we have clear line of sight to the $10 billion to $13 billion in 2025. Adam can walk you through a lot of the specifics around the confidence for the remainder of this year. What I would highlight, though, is some of what you've already heard on this call, we continue to see a really nice uptake on Camzyos. We had the access wins that Adam alluded to on SOTYKTU, Opdualag is clearly going to continue to be important.

也許我會開始，馬特，然後我會把它交給亞當，然後再去找薩米特。正如我之前提到的，馬特，我們仍然對這個投資組合的進展充滿信心。我們今年仍有望使該投資組合的收入大約翻一番。推而廣之，我們對 2025 年 100 億至 130 億美元的目標有清晰的認識。Adam 可以向您介紹有關今年剩餘時間信心的許多具體細節。不過，我要強調的是，您在這次電話會議中已經聽到的一些內容，我們繼續看到 Camzyos 得到了很好的採用。我們取得了 Adam 在 SOTYKTU 上提到的訪問勝利，Opdualag 顯然將繼續發揮重要作用。

And while we've discussed the dynamics on Abecma with respect to manufacturing, keep in mind, that we have a number of catalysts coming with Abecma. But more importantly, we've seen a really nice continued growth with Breyanzi as well. But Adam, anything you would add?

雖然我們已經討論了 Abecma 在製造方面的動態，但請記住，Abecma 帶來了許多催化劑。但更重要的是，我們也看到了 Breyanzi 的持續增長。但是亞當，你還有什麼要補充的嗎？

I guess just to put a finer point, what we said was, through the first half of the year, we're annualizing at $3.5 billion. But as Chris alluded to, we have a number of catalysts to accelerate growth of our new product portfolio in the second half of the year, which we said we would roughly double sales from last year. So just -- and as Chris mentioned, with Reblozyl in the first line, we're looking forward to the PDUFA date for COMMANDS. As David mentioned, we're also pleased with our -- really to pull forward a large PBM this year for SOTYKTU, and those patients will shift to commercial product from Bridge over the next 2 to 3 months.

我想更具體地說，我們所說的是，今年上半年，我們的年化收入為 35 億美元。但正如克里斯所提到的，我們有許多催化劑可以在今年下半年加速新產品組合的增長，我們表示我們的銷售額將比去年增加一倍。正如 Chris 提到的，Reblozyl 位於第一行，我們期待著 COMMANDS 的 PDUFA 日期。正如 David 提到的，我們也很高興今年確實為 SOTYKTU 推進了一項大型 PBM，這些患者將在接下來的 2 到 3 個月內轉向 Bridge 的商業產品。

And also, as Chris mentioned, Camzyos, we expect a continued steady flow of patients coming into our hub and then moving out to commercial product in the back end of the year. Remember, that takes around 8 to 10 weeks for patients to move from our hub into commercial product. And finally, we're continuing to increase supply for Abecma in advance of our KarMMa-3 launch, as well as ramping [split] for Breyanzi in the back end of the year. And for those reasons, we remain committed to roughly doubling our sales of new products this year.

此外，正如 Camzyos Chris 提到的，我們預計患者將持續穩定地進入我們的中心，然後在今年年底轉向商業產品。請記住，患者從我們的中心轉向商業產品大約需要 8 到 10 週的時間。最後，我們將在 KarMMa-3 發射之前繼續增加 Abecma 的供應，並在今年年底增加 Breyanzi 的供應。出於這些原因，我們仍然致力於將今年新產品的銷量大約增加一倍。

Thanks, Adam, and thanks, Matt, for the question. On Opdualag, non-small cell lung cancer randomized Phase II study is continuing to enroll and ongoing. We have not seen the data, and that decision will be based on meeting -- proceeding to Phase III will be based on looking at the overall data set from both overall response rate, but also the PFS directionally where it goes. So that's why I was saying that we'll get to see that data set more so in early part of 2024.

謝謝亞當，也謝謝馬特提出的問題。 Opdualag 上的非小細胞肺癌隨機 II 期研究正在繼續招募並正在進行中。我們還沒有看到數據，該決定將基於會議 - 進入第三階段將基於從總體響應率以及 PFS 的方向查看總體數據集。這就是為什麼我說我們將在 2024 年初更多地看到該數據集。

We're really a little short in time. So maybe I'll squeeze a few more. (Operator Instructions)

我們的時間確實有點短。所以也許我會再擠一些。 （操作員說明）

Our next question comes from Trung Huynh from Credit Suisse.

我們的下一個問題來自瑞士信貸銀行的 Trung Huynh。

One, I guess, on Eliquis total sales decline this quarter for the first time, I think. So perhaps can you talk about some of those dynamics you're seeing with the gross to net in the U.S. and faster EU erosion? How should we think about the price demand for the rest of the year and then into the future?

我想，其中之一是 Eliquis 本季度總銷售額首次下降。那麼，也許您能談談您所看到的美國的毛淨值和歐盟更快的侵蝕的一些動態嗎？我們應該如何看待今年剩餘時間以及未來的價格需求？

As you heard from David, Eliquis had unfavorable gross to net adjustments in the quarter. What we saw is an increase in Medicare and PHS patients, as you probably know, there's a lag in getting claims. And those claims came in, in the second quarter. So really, that's a unfavorable adjustment. But we're very pleased with what we're seeing with Eliquis in the U.S. Remember, 75% of Eliquis' business remains in the U.S., and we expect continued strong growth. Our share -- our NBRx share is north of 70% and continues to grow. Our TRx share continues to not only go strong, but continues with linear growth, coupled with the OAC market, which is also accelerating since the beginning of the year.

正如您從 David 那裡聽到的那樣，Eliquis 在本季度的總淨值調整中出現了不利的情況。我們看到的是醫療保險和 PHS 患者的增加，正如您可能知道的那樣，獲得索賠存在滯後。這些說法是在第二季度出現的。事實上，這是一個不利的調整。但我們對 Eliquis 在美國看到的情況非常滿意。請記住，Eliquis 75% 的業務仍在美國，我們預計將繼續強勁增長。我們的份額——我們的 NBRx 份額超過 70%，並且還在繼續增長。我們的 TRx 份額不僅持續強勁，而且繼續線性增長，再加上 OAC 市場自年初以來也在加速增長。

Now you also mentioned about ex U.S. dynamics, international dynamics. We are seeing demand increases, but that's offset by the impact of price erosion in a number of our European markets. David talked about the impact of generic penetration in Canada and the U.K., with (inaudible) exclusivity in both those markets. But overall, we're very pleased with Eliquis' performance, and we would expect continued strong growth.

現在您還提到了前美國動態、國際動態。我們看到需求增加，但這被許多歐洲市場價格侵蝕的影響所抵消。大衛談到了仿製藥在加拿大和英國的滲透率以及在這兩個市場的（聽不清）排他性的影響。但總體而言，我們對 Eliquis 的業績非常滿意，並且預計將繼續強勁增長。

Thanks, Adam.

謝謝，亞當。

Our next question comes from David Risinger from Leerink Partners.

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

So my question is on Revlimid volume expectations. So could you please provide some more color on go-forward generic anticipated volumes, specifically any volume inflections to watch over the next 12 to 18 months.

所以我的問題是關於 Revlimid 的銷量預期。那麼，您能否提供有關未來一般預期交易量的更多信息，特別是未來 12 至 18 個月內需要關注的任何交易量變化。

Thanks, David. As we talked about before, it's -- we saw more volumes come in that were expected in March of this year. The next inflection point will be in March of '24 and then February of the following year. So those are the 2 ones which are planned step down. And I think it's important as Giovanni had said earlier, as you think about the forecast for Revlimid on a go-forward basis, we changed the guidance this year from $6.5 million down to $5.5 billion, with a step-down of $1.5 billion next year, $2 billion in '25, which will get you to essentially where consensus was previously. So no change to where we were.

謝謝，大衛。正如我們之前談到的，我們看到今年 3 月份的銷量超出了預期。下一個拐點將在24年3月和次年2月。這就是計劃下台的兩個人。我認為這很重要，正如 Giovanni 之前所說，當你考慮來那度胺的未來預測時，我們將今年的指導從 650 萬美元下調至 55 億美元，明年下調了 15 億美元， 20 年 20 億美元，這將使您基本上達到先前的共識。所以我們所在的位置沒有改變。

Thanks, David.

謝謝，大衛。

Our next question comes from Mohit Bansal from Wells Fargo.

我們的下一個問題來自富國銀行的 Mohit Bansal。

My question is regarding the in-line portfolio. How confident do you feel about the growth trends you -- or expect this outlook you provided in the beginning of the year? Asking because, by our math, it was about for 8% growth. And if you account for the $300 million down revision for Pomalyst, it seems like 7% growth. And considering you have been growing 2% including FX and 3% excluding FX so far, just wanted to understand if you still feel [wondering] about that growth outlook at this point.

我的問題是關於在線投資組合。您對您在年初提供的增長趨勢或預期的前景有多大信心？之所以這麼問，是因為根據我們的計算，增長率約為 8%。如果考慮到 Pomalyst 3 億美元的下調，那麼增長似乎為 7%。考慮到到目前為止，包括外彙在內的增長為 2%，不包括外彙的增長為 3%，只是想了解此時您是否仍然對增長前景感到[想知道]。

Mohit, yes, we -- so remember, the discussions that we had -- and I'll ask Adam to jump in. But remember the discussion that we had was, in fact, we've updated our expectations for Pomalyst and for Revlimid. And for Pomalyst, specifically, about $300 million for this year and 20% roughly of the $330 million that we saw for Revlimid for the first quarter. When looking at the totality of performance for the in-line business, we continue to feel really strongly about the strength of the trends. And that's one of the reasons why we feel very confident at reaffirming the guidance for '25, both for our in-line portfolio and for the new products.

Mohit，是的，我們 - 所以請記住我們進行的討論 - 我會請 Adam 介入。但請記住，我們進行的討論實際上是我們更新了對 Pomalyst 和 Revlimid 的期望。具體來說，對於 Pomalyst，今年的銷售額約為 3 億美元，約為 Revlimid 第一季度 3.3 億美元的 20%。在審視內聯業務的整體業績時，我們仍然對趨勢的強度有強烈的感受。這就是為什麼我們非常有信心重申 25 年的指導，無論是對於我們的內嵌產品組合還是新產品。

Thanks, Giovanni.

謝謝，喬瓦尼。

Our next question comes from Colin Bristow from UBS.

我們的下一個問題來自瑞銀集團的科林·布里斯托。

This is Yihan on for Colin. So we all know like you will have your R&D Day on September 14, so just wondering if we could have a teaser trailer. What should we expect here? Are you going to share any new data on this event? And the (inaudible), it is on your CAR-T (inaudible). So we recently noted you initiated a Phase I trial of our CD19 CAR-T in SLE, which has a primary completion date in 2028. So you previously noted you would go first on this program, so just wondering if there's any guidance on the timing of the data readout.

這是伊涵為科林做的發言。我們都知道您將在 9 月 14 日度過研發日，所以想知道我們是否可以發布預告片。我們應該期待什麼？您打算分享有關此事件的任何新數據嗎？ （聽不清），它在你的 CAR-T 上（聽不清）。因此，我們最近注意到您啟動了針對 SLE 的 CD19 CAR-T 的 I 期試驗，該試驗的主要完成日期為 2028 年。所以您之前指出您將首先進行該計劃，所以只是想知道是否有關於時間安排的任何指導的數據讀出。

Yihan, it's Chris. I will start, and then Samit can very quickly hit on the CAR-T question. Look, we're excited about the opportunity to spend some dedicated time talking about R&D. The focus on the day will be a few things. We'll obviously walk through the R&D strategy. We'll give you an update on the pipeline, and that will importantly include our discussion around some of the programs and platforms that we're most excited about. When you step back and look at where we are, we are actually entering a catalyst-rich period for the company. And I think this is going to be an important opportunity for us to talk about some of those catalysts in more detail. So we're really looking forward to hosting the event on September 14. Samit?

伊涵，是克里斯。我先開始，然後 Samit 可以很快談到 CAR-T 問題。看，我們很高興有機會花一些時間專門討論研發。當天的焦點將是幾件事。顯然，我們將詳細介紹研發策略。我們將為您提供有關管道的最新信息，其中重要的是包括我們圍繞我們最興奮的一些計劃和平台的討論。當你退後一步看看我們所處的位置時，我們實際上正在進入公司的催化劑豐富時期。我認為這將是我們更詳細地討論其中一些催化劑的重要機會。所以我們真的很期待在 9 月 14 日舉辦這次活動。Samit？

Thank you, Chris, and thank you for the question. For the next-gen CAR-T CD19 therapy, what you're seeing is that we have just started the Phase I study. There is going to be dose escalation and dose expansion. And what you will also see later this year, and possibly we might be able to talk about it in September, we will be adding additional indications. So we are taking that into account and putting the dates into the system in control (inaudible). But certainly, there will be earlier data readouts and earlier data sharing prior to that date. So we'll need to inform as we progress with the study conduct.

謝謝你，克里斯，也謝謝你提出的問題。對於下一代 CAR-T CD19 療法，您看到的是我們剛剛開始 I 期研究。將會出現劑量遞增和劑量擴大。今年晚些時候您還將看到，我們可能會在 9 月份討論它，我們將添加額外的指示。因此，我們正在考慮這一點，並將日期放入系統中進行控制（聽不清）。但當然，在此日期之前將會有更早的數據讀出和更早的數據共享。因此，隨著研究的進展，我們需要通知。

I think we may have time for 1 or 2 more.

我想我們可能還有時間再做一兩個。

Our next question comes from Dane Leone from Raymond James.

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

As you think about the conversion to commercial pay drug for those patients that you've gained market share with in SOTYKTU, it seems like, by our math on the script run rate, you're running around maybe $800 million, close to $800 million, maybe slightly above on an annualized basis, which would imply the actual pay for drug product is below 25% of total scripts that you're now generating.

當您考慮將那些您在 SOTYKTU 中獲得市場份額的患者轉換為商業付費藥物時，根據我們對腳本運行率的計算，您的運行成本約為 8 億美元，接近 8 億美元，可能略高於年化水平，這意味著藥品的實際費用低於您現在生成的總腳本的 25%。

For your guidance to convert those free drug patients to commercial pay over the next several months, does that take a penalty of continued market share gains that you've already carved out? Or do you expect to continue taking additional market share while converting to free drug into the end of the year? And then just one quick question, does your ASR agreement -- is that included in your EPS guidance? Or is that in addition to your EPS guidance for the full year?

對於您在未來幾個月內將這些免費藥物患者轉變為商業付費的指導，這是否會損害您已經獲得的持續市場份額增長？或者您是否預計在年底前轉向免費藥物的同時繼續佔據更多市場份額？還有一個簡單的問題，你們的 ASR 協議是否包含在你們的 EPS 指南中？或者這是您全年每股收益指導之外的？

Yes, David. Thank you, Dane. David, why don't you start and then Adam can answer the question on SOTYKTU.

是的，大衛。謝謝你，丹恩。 David，你為什麼不開始，然後 Adam 可以在 SOTYKTU 上回答問題。

Yes. Thank you, Dane. Yes, it is included in our guidance. As we said, we anticipate doing about $4 billion ASR in the third quarter. And just remember, the dynamics of those ASR is about 80% of the shares retired upon execution of that, and the remaining 20% happens over the contract period.

是的。謝謝你，丹恩。是的，它包含在我們的指南中。正如我們所說，我們預計第三季度的 ASR 收入約為 40 億美元。請記住，這些 ASR 的動態是大約 80% 的股份在執行後退役，其餘 20% 在合同期內發生。

Yes, Dane, thanks. As it relates to SOTYKTU, as I mentioned, certainly, our objective is to continue to grow market share. As I said it's nearing 40%, we continue to see month-over-month increases. And we feel very good about where our market share is trending towards the back end of the year. Our objective is to surpass Otezla. And so when you think about where we are today, we have doubled the volume of TRx equivalents from Q2 to Q1, and we expect that also to accelerate.

是的，丹恩，謝謝。正如我提到的，與 SOTYKTU 相關，我們的目標當然是繼續擴大市場份額。正如我所說，接近 40%，我們繼續看到逐月增長。我們對今年年底的市場份額趨勢感到非常滿意。我們的目標是超越 Otezla。因此，當你想想我們今天的處境時，我們已經將 TRx 等價物的數量從第二季度到第一季度增加了一倍，並且我們預計這一趨勢也會加速。

It will take time. to move patients from bridge to commercial drug, certainly around, as I mentioned, 2 to 3 months. So that ramp will happen in the back end of the year. And as we start to unlock other plans starting in January of next year, we'll also see that start to take place as well, more patients moving into commercial supply. So we feel very good about opportunity growth prospects for SOTYKTU in the back end of this year and certainly into 2024.

需要花時間。將患者從過渡藥物轉移到商業藥物，正如我提到的，肯定需要 2 到 3 個月的時間。因此，這種增長將在今年年底發生。當我們從明年一月開始解鎖其他計劃時，我們也將看到這種情況也開始發生，更多的患者進入商業供應。因此，我們對 SOTYKTU 在今年年底以及 2024 年的機會增長前景感到非常看好。

Thanks, Adam. Let's go to our last question, please, Jamie.

謝謝，亞當。傑米，請讓我們討論最後一個問題。

Our final question today will come from Olivia Brayer from Cantor Fitzgerald.

我們今天的最後一個問題將來自坎托·菲茨杰拉德的奧利維亞·布雷耶。

I wanted to follow up on Abecma's manufacturing capacity going forward. I know you had that shutdown in June, but is that a headwind that we should be factoring in for most years? And is there a way to minimize the revenue disruption from future shutdowns going forward? And then just quickly on LAG-3 in lung, how are you thinking about the bar for success in that Phase II? And what's the strategy and timing for moving into registrational studies?

我想跟進 Abecma 未來的生產能力。我知道你們在六月關閉了，但這是否是我們多年來應該考慮的逆風？有沒有辦法最大限度地減少未來因停工而造成的收入中斷？然後，關於肺部 LAG-3，您如何看待第二階段成功的標準？進入註冊研究的策略和時機是什麼？

I'll take the first question, Olivia. Thanks for the question. So as it relates to manufacturing and the capacity shutdown. So we're making very good progress to increase our capacity across our cell therapy franchise, both Abecma and Breyanzi. I talked about the 2 components of that. But as it relates to the manufacturing shutdown, that really is limited to Abecma, because (inaudible) where Abecma is manufactured. And so all of our shutdowns are planned, accounted for in our capacity plans. This is routine shutdown to execute maintenance at our site for approximately 1 month.

我來回答第一個問題，奧利維亞。謝謝你的提問。這與製造和產能關閉有關。因此，我們在提高細胞治療特許經營權（Abecma 和 Breyanzi）的能力方面取得了非常好的進展。我談到了其中的兩個組成部分。但由於涉及生產停工，這實際上僅限於 Abecma，因為（聽不清）Abecma 是在哪裡生產的。因此，我們所有的停工都是有計劃的，並已納入我們的產能計劃中。這是為了在我們的站點執行大約 1 個月的維護而進行的例行停機。

And the ramp for Abecma is really tied to overall supply plans with KarMMa-3 being one important aspect of that ramp. And that's important because we now have over 90% manufacturing success rates and multiple ramp since launch. So this routine manufacturing maintenance process are really important for us to continue our strong success rate and build our readiness for increase capacity in advance of the KarMMa-3 launch. So as David mentioned, that will have some impact in Q3, and we expect our Abecma sales to accelerate in Q4 and certainly into 2024.

Abecma 的產能擴張確實與整體供應計劃緊密相關，KarMMa-3 是該產能擴張的一個重要方面。這很重要，因為我們現在的製造成功率超過 90%，並且自推出以來已實現多次產能提升。因此，這種例行製造維護流程對於我們保持強勁的成功率並在 KarMMa-3 發射之前做好增加產能的準備非常重要。正如 David 提到的，這將對第三季度產生一些影響，我們預計 Abecma 的銷售將在第四季度加速，並且肯定會持續到 2024 年。

Yes. And very quickly on the question on LAG-3 non-small cell lung cancer. The Phase II study is combining of Opdualag with chemotherapy, comparing versus [nivo plus] chemotherapy. But for the Phase III trial, we intend to do the combination comparison versus pembrolizumab plus chemotherapy. So we have to keep that in mind as we look at the data evolution and the outcome so that we have the appropriateness in terms of the magnitude of effect that we need to see in Phase III. So that's our bar.

是的。很快就關於 LAG-3 非小細胞肺癌的問題。 II 期研究是將 Opdualag 與化療相結合，與 [nivo plus] 化療進行比較。但對於 III 期試驗，我們打算與派姆單抗加化療進行組合比較。因此，在研究數據演變和結果時，我們必須牢記這一點，以便我們在第三階段需要看到的影響程度是適當的。這就是我們的酒吧。

And in terms of the start of the study, it depends on when the study reads out, and then we are ready and prepared to quickly launch the Phase III program depending on (inaudible) supportive.

就研究的開始而言，這取決於研究結果何時公佈，然後我們準備好並準備根據（聽不清）的支持快速啟動第三階段計劃。

So thank you, everyone. So as I think about the quarter, first of all, I want to say, obviously, we provided an important update to our outlook for the year. We don't take that lightly. At the same time, when I look at the future of the company, we remain and I am very optimistic about where we are driven by the discussion we had about our in-line products, the performance of the launch portfolio and the strength of our pipeline.

謝謝大家。因此，當我想到本季度時，首先，我想說，顯然，我們對今年的前景進行了重要更新。我們不會掉以輕心。與此同時，當我展望公司的未來時，我們仍然對我們的內線產品、推出產品組合的表現以及我們的實力的討論所推動的方向感到非常樂觀。管道。

With that, I want to thank you for participating. Our team, as always, remains available to answer any questions you may have. And wish everyone a good day.

在此，我要感謝您的參與。我們的團隊一如既往地隨時回答您的任何問題。並祝大家有美好的一天。

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.

女士們先生們，我們今天的電話會議和演示就到此結束。我們感謝您的加入。您現在可以斷開線路。