施貴寶 (BMY) 2024 Q2 法說會逐字稿

Good day and welcome to the Bristol Myers Squibb second quarter 2024 earnings conference call. (operator instructions) Please note, today's event is being recorded. I would now like to turn the conference over to Tim Power, Vice President, Head of Investor Relations. Please go ahead.

美好的一天，歡迎參加百時美施貴寶 2024 年第二季財報電話會議。 （操作員說明）請注意，今天的活動正在錄製中。現在我想將會議交給副總裁兼投資者關係主管 Tim Power。請繼續。

Thank you, and good morning, everyone. Thanks for joining us this morning for our second quarter 2024 earnings call. Joining me this morning with prepared remarks are Chris Boerner are Board Chair and Chief Executive Officer; and David Elkins our Chief Financial Officer. Also participating in today's call, Adam Lenkowsky, our Chief Commercialization Officer, and Samit Hirawat, our Chief Medical Officer and Head of Global developments.

謝謝大家，大家早安。感謝您今天早上參加我們的 2024 年第二季財報電話會議。今天早上與我一起發表事先準備好的演講的是董事會主席兼首席執行官 Chris Boerner；和我們的財務長大衛埃爾金斯。我們的首席商業化長 Adam Lenkowsky 和我們的首席醫療官兼全球開發主管 Samit Hirawat 也參加了今天的電話會議。

As you'll note, we've posted slides to bms.com that you can use to follow along with Chris and David's remarks.

您將注意到，我們已將投影片發佈到 bms.com，您可以使用這些投影片來了解 Chris 和 David 的言論。

Before we get started, I'll read our forward looking statements. During this call, we may make statements about the company's future plans and prospects constitute forward-looking statements. Actual results may differ materially from those indicated by those 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 represent our estimates as of any future date. #

在我們開始之前，我將閱讀我們的前瞻性聲明。在這次電話會議中，我們可能會做出有關公司未來計畫和前景的陳述，這些陳述構成前瞻性陳述。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有重大差異。這些前瞻性陳述代表了我們截至目前為止的估計，不應被視為代表我們截至未來任何日期的估計。 #

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.

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 指標的調整表可在 bms.com 上找到。

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

有了這個，我會把它交給克里斯。

Thanks, Jim, and thanks, everyone, for joining us this morning. Starting on Slide 4, our second quarter results reflect continued progress against our strategy to position BMS for long-term sustainable growth. In Q2, we continued to strengthen commercial performance with uptake accelerating across a number of our marketed products.

謝謝吉姆，也謝謝大家今天早上加入我們。從投影片 4 開始，我們第二季的業績反映了我們為 BMS 實現長期永續成長的策略所取得的持續進展。在第二季度，我們繼續加強商業業績，我們的許多已上市產品的吸收速度加快。

Growth portfolio revenues increased 18% year over year or 21%, excluding the impact of foreign exchange. This portfolio is on track to be a larger component of our overall mix moving forward. We also advanced our pipeline, demonstrating the strength of our portfolio and the development of our first or best in class assets this includes US regulatory approvals for Breyanzi, Krazati and Augtyro.

成長投資組合營收年增 18%，即 21%（排除外匯影響）。該產品組合有望成為我們未來整體組合的重要組成部分。我們還推進了我們的產品線，展示了我們投資組合的實力以及我們首個或最好的一流資產的開發，其中包括 Breyanzi、Krazati 和 Augtyro 獲得美國監管機構的批准。

We also achieved a number of milestones this quarter for our I-O franchise, including European approval in first-line bladder cancer, presented data at Asco in first-line liver cancer and are progressing to a more convenient subcutaneous formulation of nivolumab, where we now have a producer date from the US FDA of December 29. The EMA is also reviewing our subcu application.

本季度我們的I-O 特許經營權還實現了許多里程碑，包括在歐洲批准用於一線膀胱癌、在Asco 上展示了一線肝癌的數據，並正在開發更方便的納武單抗皮下製劑，我們現在擁有這種製劑美國 FDA 的生產日期為 12 月 29 日。

Before we get into more details around quarterly performance. On Slide 5, I'd like to step back and take stock where we are as a company and where we are headed. As discussed previously, we are focusing on reshaping be BMS to achieve sustained top tier growth and maximize long-term value, were doing this by focusing on three key objectives.

在我們詳細了解季度業績之前。在投影片 5 上，我想退後一步，盤點一下我們作為一家公司的現狀以及我們的發展方向。如前所述，我們致力於重塑 BMS，以實現持續的頂級成長並最大化長期價值，我們透過專注於三個關鍵目標來實現這一目標。

First, we are focusing our portfolio on transformational medicines where we have a competitive advantage, this means advancing and were possible, accelerating first or best in class treatments across our therapeutic areas, prioritizing pipeline assets with meaningful growth potential and discontinuing programs that no longer meet our threshold for return on investment. Through these actions, we are ensuring our R&D efforts are focused on programs were BMS has a right to win and where we can deliver compelling ROI to shareholders.

首先，我們將我們的產品組合重點放在我們擁有競爭優勢的轉型藥物上，這意味著前進並成為可能，加速我們治療領域的一流或一流治療，優先考慮具有有意義的成長潛力的管道資產，並停止不再滿足要求的項目我們的投資回報門檻。透過這些行動，我們確保我們的研發工作集中在 BMS 有權獲勝並且能夠為股東提供引人注目的投資回報率的項目上。

Second, we are actively driving greater operational excellence throughout the organization, this include streamlining our operations and focusing the organization on what matters most becoming more efficient in how we operate, improving R&D productivity and driving a culture that emphasizes speed and accountability. We're executing on our cost reduction efforts and are on track to achieve the $1.5 billion in cost savings as we announced in Q1.

其次，我們正在整個組織中積極推動卓越運營，這包括簡化我們的運營，讓組織專注於最重要的事情，提高運營效率，提高研發生產力，並推動強調速度和責任的文化。我們正在努力降低成本，並有望實現第一季宣布的 15 億美元成本節約。

Third, we are strategically allocating capital for long-term growth and returns. We remain focused on ensuring we are investing behind our growth portfolio and most critical pipeline assets, business development and partnerships remain important for us, and we continued to strengthen our balance sheet well maintaining our commitment to returning cash to shareholders.

第三，我們正在策略性地配置資本以實現長期成長和回報。我們仍然專注於確保投資於我們的成長投資組合和最關鍵的管道資產，業務發展和合作夥伴關係對我們仍然很重要，我們繼續加強我們的資產負債表，並保持我們向股東返還現金的承諾。

Taken together, these actions are ensuring we're focused on the highest value activities across the organization, tightening our execution, where needed and accelerating our ability to deliver important medicines to patients.

總而言之，這些行動確保我們專注於整個組織中最高價值的活動，在需要時加強我們的執行力，並加快我們向患者提供重要藥物的能力。

On that note, turning to slide 6, our objective of generating top-tier growth requires us to deliver on the potential of our pipeline, in hematology oncology, we're driving leadership by extending our I-O business and broadening our focus to include cell therapies and protein degraders, we have also expanded into ADCs in radiopharmaceuticals.

在這一點上，轉向幻燈片 6，我們實現頂級成長的目標要求我們發揮我們的產品線的潛力，在血液腫瘤學方面，我們透過擴展 I-O 業務並擴大我們的重點以包括細胞療法來推動領導地位和蛋白質降解劑，我們也擴展到放射性藥物中的ADC。

In cardiovascular, wxe are leveraging decades of expertise to deliver new treatment options in thrombosis, heart failure and cardiomyopathies. In immunology, we're focusing our R&D efforts on therapies that reset the immune system with a potentially transformational program in cell therapy.

在心血管領域，wxe 正在利用數十年的專業知識為血栓形成、心臟衰竭和心肌病變提供新的治療選擇。在免疫學方面，我們的研發工作重點是透過細胞療法中潛在的變革計畫來重置免疫系統的療法。

And finally, we are re-establishing our presence in neuroscience, starting with KarXT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance nicely.

最後，我們正在重新確立我們在神經科學領域的地位，從神經精神病學領域的 KarXT 開始，隨後是神經退化性疾病方面令人興奮的管道，該管道繼續順利推進。

On slide 7, let me update you on progress with KarXT specifically. We have two main objectives preparing for the upcoming launch and executing against a robust clinical program to expand this important therapy in multiple indications. We are rapidly building out the necessary infrastructure ahead of KarXT anticipated FDA approval in late September.

在投影片 7 上，我將具體向您介紹 KarXT 的進展。我們有兩個主要目標，為即將推出的產品做好準備，並執行強大的臨床計劃，以將此重要療法擴展到多種適應症。在 KarXT 預期 FDA 於 9 月底獲得批准之前，我們正在快速建造必要的基礎設施。

We're excited about the commercial potential for this product. Adam can speak more about our launch prep in Q&A. As previously discussed, we are also expanding KarXT to additional indications with data expected in adjunctive schizophrenia in 2025 and Alzheimer's disease psychosis in 2026. Our plans to start trials in both Alzheimer's agitation in bipolar disorder are on track.

我們對該產品的商業潛力感到興奮。 Adam 可以在問答中更多地談論我們的發布準備工作。如前所述，我們也將KarXT 擴展到其他適應症，預計2025 年將獲得輔助性精神分裂症和2026 年阿茲海默症精神病的數據。氏躁動症的試驗的計劃正在按計劃進行。

Finally, we have also initiated planning for two new indications for this product and autism spectrum disorders and Alzheimer's cognition.

最後，我們也開始規劃該產品的兩個新適應症，即自閉症譜系障礙和阿茲海默症。

On slide 8, I want to highlight a few important pipeline milestones across our therapeutic areas this year. In hematology oncology, we're extending our I-O franchise with nivolumab subcu and lung data for Opdualag. With the anticipated launch of the subcutaneous formulation of nivolumab at the end of this year, we continue to estimate that at least 30% to 40% of US patients being treated with IV will convert to the more convenient subcutaneous administration across multiple indications. This ultimately allows patients to benefit from the standard of care cancer medicine into the next decade.

在投影片 8 上，我想強調今年我們治療領域的一些重要的管道里程碑。在血液腫瘤學領域，我們正在利用 nivolumab subcu 和 Opdualag 的肺部數據擴展我們的 I-O 專營權。隨著納武單抗皮下製劑預計在今年年底推出，我們繼續估計，至少 30% 至 40% 接受靜脈注射治療的美國患者將在多種適應症中轉向更方便的皮下注射。這最終使患者在未來十年能夠從標準的癌症醫學護理中受益。

With Opdualag, we plan to share Phase 2 proof of concept data soon. This supports initiation of a Phase 3 study in a subset of patients with first-line non-small cell lung cancer, later this year. In Immunology we except to see data this year for CD19 NEX-T. By resetting the immune system, we believe this therapy can deliver a meaningful benefits for patients across multiple indications. We've also completed enrollment of our two Phase 3 trials for SOTYKTU and psoriatic arthritis and now expect to see data later this year.

透過 Opdualag，我們計劃很快分享第二階段的概念驗證資料。這支持今年稍後在一線非小細胞肺癌患者中啟動一項 3 期研究。在免疫學方面，我們今年除了看到 CD19 NEX-T 的數據外。透過重置免疫系統，我們相信這種療法可以為多種適應症的患者帶來有意義的益處。我們還完成了 SOTYKTU 和銀屑病關節炎兩項 3 期試驗的招募，現在預計將在今年稍後看到數據。

Looking ahead on slide 9, we will begin to see important data readouts for our pipeline in the second half of this year with momentum building through 2026. A few to focus on include LPA1 in pulmonary fibrosis, our registrational multiple myeloma pipeline, including GPRC5D cell therapy and our Golcadomide, Iberdomide Mezigdomide, and of course, no vaccine, which has the potential to be the only oral factor XIa inhibitor in atrial fibrillation.

展望幻燈片9，我們將在今年下半年開始看到我們的管道的重要數據讀數，並且勢頭將持續到2026 年。管道，包括GPRC5D 細胞療法和我們的 Golcadomide、Iberdomide Mezigdomide，當然也沒有疫苗，它有可能成為心房顫動中唯一的口服 XIa 因子抑制劑。

All have the potential to deliver significant benefits for patients and form a large commercial opportunity for the company. With increasing pipeline momentum, we are confident in our ability to further strengthen our growth profile.

所有這些都有可能為患者帶來顯著的好處，並為公司形成巨大的商業機會。隨著管道動力的不斷增強，我們對進一步增強成長前景的能力充滿信心。

Let me close with our outlook on Slide 10. Given the strength of our Q2 results and the confidence we have in the remainder of the year, we now expect to deliver top line growth at the upper end of our guidance range. We are also raising our guidance range for full year EPS.

讓我以幻燈片 10 的展望作為結束語。我們也提高了全年每股收益的指導範圍。

David will discuss these updates in more detail shortly.

大衛將很快更詳細地討論這些更新。

Let me summarize by noting that in Q2, we took notable steps forward on our journey to drive sustained long-term growth. While there's more work to do, we are strengthening the foundation for that growth by progressing what is a catalyst-rich pipeline, growing our commercial portfolio and maintaining a strong balance sheet that provides strategic flexibility. I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster.

讓我總結一下，在第二季度，我們在推動持續長期成長的道路上取得了顯著的進步。雖然還有更多工作要做，但我們正在透過推動富含催化劑的管道、擴大我們的商業投資組合以及維持提供策略靈活性的強大資產負債表來加強成長的基礎。我要感謝 BMS 的員工在本季度做出的貢獻以及他們致力於更快地為更多患者提供突破性藥物的承諾。

Let me now hand it over to David.

現在讓我把它交給大衛。

Thank you, Chris, and good morning, everyone.

謝謝你，克里斯，大家早安。

I will begin with the highlights of our quarterly sales results on Slide 12. Let me start with a brief reminder that unless otherwise stated, all comparisons are made from the same period in 2023 and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange, all references to our P&L or on non-GAAP basis.

我將首先在投影片 12 上重點介紹我們的季度銷售業績 首先我要簡要提醒一下，除非另有說明，否則所有比較均來自 2023 年同期，並且將在基礎上討論銷售增長率，這不包括外匯的影響，所有參考我們的損益表或非公認會計準則的基礎。

Our performance during the second quarter reflects focused execution across the business, including a 21% increase in our growth portfolio and a 3% growth in our legacy portfolio. The growth portfolio continued to increase as a proportion of total sales and now represents about 46% of the business.

我們第二季的業績反映了整個業務的重點執行，包括我們的成長投資組合成長了 21%，我們的傳統投資組合成長了 3%。成長型產品組合佔總銷售額的比例持續增加，目前約佔業務的 46%。

Expenses during the quarter came in more favorable than expected, reflecting our focus on driving operational excellence and timing of spend, resulting in a slightly higher operating margin of roughly 40%, these results support our positive outlook for 2024 and our updated financial guidance.

本季的支出比預期更有利，反映出我們專注於推動卓越營運和支出時機，導致營業利潤率略高，約為 40%，這些結果支持了我們對 2024 年的積極展望和更新的財務指引。

Second quarter's performance across our key therapeutic areas reflect continued momentum for several important growth brands, including Reblozyl, CAMZYOS, Breyanzi, and Opdualag. While we saw growth across our immunology business, we recognize there's still more work to do, particularly with Sotyktu in this highly competitive category.

第二季度我們關鍵治療領域的表現反映了幾個重要成長品牌的持續成長勢頭，包括 Reblozyl、CAMZYOS、Breyanzi 和 Opdualag。雖然我們看到免疫學業務的成長，但我們認識到還有更多工作要做，特別是在 Sotyktu 這個競爭激烈的類別中。

There are also some inventory and grow the net favorability across several growth brands this quarter, which will be important to take into consideration when facing sales in the second half of the year. Let's take a closer look at our key brand performance, starting with our oncology franchise on Slide 13.

本季幾個成長品牌的庫存也有所增加，淨好感度也有所提高，這在面對下半年的銷售時需要考慮到這一點。讓我們從幻燈片 13 上的腫瘤專營權開始，仔細看看我們的主要品牌表現。

Opdivo remains an important product within our immuno oncology business. Sequentially, global sales were up driven by demand and estimated benefit of $65 million related to customer buying patterns in the US. We expect growth this year to be in the mid-single digit range as core indications mature, and we await additional regulatory actions, including FDA approval in the Peri-adjuvant lung expected in October, and our I-O franchise is further strengthened with Opdualag, which delivered another quarter of double digit growth, driven primarily by higher demand.

Opdivo 仍然是我們免疫腫瘤業務中的重要產品。隨後，全球銷售額在需求和美國客戶購買模式相關的預期收益 6,500 萬美元的推動下有所增長。隨著核心適應症的成熟，我們預計今年的成長將在中個位數範圍內，我們正在等待更多的監管行動，包括FDA 預計在10 月批准的周圍輔助肺治療，並且我們的I-O 特許經營權透過Opdualag 進一步加強，在需求增加的推動下，又一個季度實現了兩位數的成長。

Outside the US, we see encouraging trends across several newly launched markets and remain focused on securing reimbursement. As we said, previously, we are pursuing further development of Opdualag in a segment of first line lung cancer, and we remain on track to initiate our Phase 3 registrational program later this year, these expansion opportunities, coupled with the pending approval of nivolumab, subcu further support extension of our I-O franchise into the next decade.

在美國以外，我們在幾個新推出的市場中看到了令人鼓舞的趨勢，並繼續專注於確保報銷。正如我們之前所說，我們正在尋求 Opdualag 在一線肺癌領域的進一步開發，並且我們仍有望在今年晚些時候啟動我們的 3 期註冊計劃，這些擴展機會，加上等待批准的 nivolumab， subcu 進一步支持將我們的I-O 特許經營權擴展到下一個十年。

In cardiovascular, On Slide 14, I'll Eliquis remains the market leader anticoagulant worldwide with global sales and more than $3 billion. In the US sales were primarily driven by higher demand and market share gains. Sequentially, as is typical in the second quarter, US sales reflect an unfavorable gross to net impact as patients begin to enter Medicare coverage gap. As a reminder, these dynamics are more acute in the second half of the year, resulting in lower sales versus the first half.

在心血管領域，在幻燈片 14 上，I'll Eliquis 仍然是全球抗凝血劑市場的領導者，全球銷售額超過 30 億美元。在美國，銷售主要受到需求增加和市場佔有率成長的推動。因此，正如第二季度的典型情況一樣，隨著患者開始進入醫療保險覆蓋缺口，美國的銷售額反映出了不利的總淨影響。需要提醒的是，這些動態在下半年更為嚴重，導致銷售量較上半年下降。

Turning to Camzyos, second quarter sales, more than tripled compared to the prior year. Sequentially, US sales were driven mainly by demand. US demand in the second quarter was led by an increase of approximately 1,300 commercially dispense patients since Q1, bringing the total to almost 6,900 patients on commercial drug, this growth demonstrates steady and consistent adoption. Outside the US sales growth reflects the timing of reimbursement and improved markets, and globally, we see significant room for future growth.

至於 Camzyos，第二季的銷售額比去年同期成長了兩倍多。因此，美國的銷售主要由需求驅動。自第一季以來，美國第二季度的需求主要由大約 1,300 名商業配藥患者的增加帶動，使使用商業藥物的患者總數達到近 6,900 名，這一增長表明了穩定和一致的採用。美國以外的銷售成長反映了報銷時機和市場改善，在全球範圍內，我們看到未來成長的巨大空間。

Let's turn to Hematology on slide 15. Sales of Reblozyl the quarter grew 82% with growth in both US and international markets. In the US sales benefited from higher demand driven by first-line MDS associate anemia and some favorable inventory gross-to-nets.

讓我們轉向幻燈片 15 上的血液學。在美國，銷售受益於一線 MDS 相關貧血症和一些有利的庫存總淨值推動的需求增加。

Outside the US, the brand is approved and approximately 40 countries, including recent broad label introductions in Europe and Japan. We look forward to seeing the first line indication reimburse across the globe. In cell therapy, we saw quarter-over-quarter sales growth with a backlog driven largely by Ex-US. We continue to work through the competitive dynamics in multiple myeloma by discussing our KarMMa-3 with customers.

該品牌在美國以外的大約 40 個國家/地區獲得批准，包括最近在歐洲和日本推出的廣泛標籤。我們期待看到一線適應症在全球範圍內得到報銷。在細胞療法方面，我們看到季度環比銷售成長，積壓訂單主要由美國以外地區推動。我們繼續透過與客戶討論我們的 KarMMa-3 來應對多發性骨髓瘤的競爭動態。

Breyanzi grew 55% in the quarter, which was driven by growth across multiple indications and expanded manufacturing capacity. International sales growth reflected strong demand in markets such as Germany, France and Japan.

Breyanzi 本季成長 55%，這得益於多個適應症的成長和製造能力的擴大。國際銷售成長反映了德國、法國和日本等市場的強勁需求。

Now, moving to immunology on slide 16. Performance Sotyktu continue to be impacted by competitive environment and the quality of commercial access in the US. At the same time, during Q2, we achieved improved commercial access across multiple large PBMs with zero step edits. And starting earlier this month, we added another large PBM as we've discussed last quarter. We now have greater than 60% of covered lives have favorable access.

現在，轉到幻燈片 16 上的免疫學。同時，在第二季度，我們透過零步驟編輯實現了跨多個大型 PBM 的商業訪問的改善。從本月早些時候開始，我們添加了另一個大型 PBM，正如我們上季度討論的那樣。現在，我們有超過 60% 的受保人享有便利的服務。

As a result, in the near term, we anticipate modest incremental gross-to-net pressure on revenue growth, which will be offset by demand growth over time.

因此，在短期內，我們預期收入成長將面臨適度的增量總淨壓力，隨著時間的推移，這種壓力將被需求成長所抵消。

Now, turning to slide 17, I will highlight some components of the P&L. In addition to solid commercial execution, our second quarter performance reflects our focus on financial discipline and steady progress against our $1.5 billion cost savings program, we discussed on last quarter's call. As a reminder, we plan to reinvest the cost savings into higher growth opportunities to drive greater patient impact and accelerate our sales growth in the second half of the decade.

現在，轉到投影片 17，我將重點介紹損益表的一些組成部分。除了可靠的商業執行力之外，我們第二季度的業績還反映出我們對財務紀律的關注以及我們在15 億美元成本節約計劃方面的穩步進展，我們在上個季度的電話會議上對此進行了討論。提醒一下，我們計劃將節省的成本重新投資於更高的成長機會，以推動更大的患者影響並加速我們在本十年後半段的銷售成長。

Gross margin came in favorable this quarter, driven primarily by product mix. Operating expenses, excluding in-process R&D were impacted by higher deal related spend, partially offset by cost savings related to our efficiency initiatives and the timing of planned expenditures. On a sequential basis, expenses came in lower than anticipated due to timing of planned investment spend that shifted to the third quarter.

本季毛利率良好，主要受到產品組合的推動。營運費用（不包括正在進行的研發）受到交易相關支出增加的影響，但部分被與我們的效率措施和計畫支出時間相關的成本節省所抵銷。從環比來看，由於計劃投資支出的時間轉移到第三季度，支出低於預期。

Our tax rate in the quarter changed from 16.9% in the prior year to 14.1%, primarily due to a release of income tax reserve. Overall earnings per share was $2.7 in the quarter.

我們本季的稅率從去年的 16.9% 變為 14.1%，主要是由於所得稅儲備金的釋放。本季每股整體收益為 2.7 美元。

Now, moving to the balance sheet and capital allocation highlights on slide 18. Both our growth and legacy portfolios delivered solid revenue growth in the quarter, with legacy continue to contribute to our robust operating cash flow of approximately $2.3 billion and we closed the quarter on June 30, we had approximately $7 billion in cash, cash equivalents and marketable debt securities on hand.

現在，轉向幻燈片18 上的資產負債表和資本配置重點。貢獻，我們結束了本季截至 6 月 30 日，我們手頭上有大約 70 億美元的現金、現金等價物和有價債務證券。

During the second quarter, we're reduced our total debt position by $3.1 billion, including roughly $2.7 billion of commercial paper and $400 million of long-term debt, these actions are consistent with our plan to pay down approximately $10 billion of debt over the next two years. In terms of capital allocation, we are prioritizing opportunities that will further strengthen our long-term growth outlook while remaining committed to our dividend.

第二季度，我們的總債務部位減少了31 億美元，其中包括約27 億美元的商業票據和4 億美元的長期債務，這些行動與我們在2019 年償還約100 億美元債務的計劃是一致的。在資本配置方面，我們正在優先考慮能夠進一步增強我們長期成長前景的機會，同時繼續致力於派息。

Please turn to slide 19 to walk through the details of our guidance. On Q2 performance, focused execution across the business generated top-line growth and driving operational excellence, these results provided support for updated full year guidance. As is our practice, we provide revenue guidance on a reported basis as well as on an underlying basis, which assumes currency remains consistent with prior year.

請翻到投影片 19 來詳細了解我們的指南。在第二季的業績方面，整個業務的集中執行帶來了營收成長並推動了卓越運營，這些結果為更新的全年指導提供了支持。按照我們的慣例，我們在報告的基礎上以及基礎基礎上提供收入指引，假設貨幣與上一年保持一致。

Our guidance for the full year revenue is now low single digit growth, which we now expect to come in at the upper end of the range. This is due to the continued performance of our growth portfolio and better than expected sales of Revlimid.

我們對全年收入的指導目前是較低的個位數成長，我們現在預計該成長將處於該範圍的上限。這是由於我們的成長型產品組合的持續表現以及 Revlimid 的銷售好於預期。

With respect to gross margin, we are raising our guidance to reflect the impact of sales mix. Excluding acquired in-process R&D, we continue to expect our total operating expenses to be at the upper end of low single digit percentage increase range, this reflects incremental costs associated with the recent acquisitions, partially offset by the realization of savings due to our productivity initiative. Given the delay in timing of anticipated expenses in Q2, we now expect a step-up in Q3. Overall, our previous operating margin target of at least 37% for the full year remains unchanged.

就毛利率而言，我們正在提高指導值以反映銷售組合的影響。不包括收購的正在進行的研發，我們仍然預計我們的總營運費用將處於低個位數百分比增長範圍的上限，這反映了與最近收購相關的增量成本，部分被我們生產力帶來的節省所抵消倡議。鑑於第二季預期支出時間的延遲，我們現在預計第三季支出將會增加。整體而言，我們先前設定的全年至少 37% 的營業利潤率目標保持不變。

For OI&E, we now expect annual expenses of approximately $50 million, due to higher than anticipated estimated royalties and favorable net interest expense. Annual tax rate would be affected by one-time non-deductible expenses of current acquired in-process R&D charge, which impacted our non-GAAP net income in the first quarter.

對於 OI&E，由於高於預期的估計特許權使用費和有利的淨利息支出，我們現在預計年度費用約為 5000 萬美元。年稅率將受到目前獲得的在製品研發費用的一次性不可扣除費用的影響，這影響了我們第一季的非 GAAP 淨利潤。

Excluding this impact, the estimated underlying tax rate for the full year is still expected to be about 18% as a result of these changes, we are raising the range of our 2024 non-GAAP EPS guidance to between $0.60 and $0.90.

排除此影響，由於這些變化，預計全年基本稅率仍約為 18%，我們將 2024 年非 GAAP 每股收益指引範圍上調至 0.60 美元至 0.90 美元之間。

Let's walk through the phasing of our sales for the full year. Year to date, our growth portfolios grown approximately 16% and we anticipate a similar rate of growth in the second half. In relation to phasing of product sales in the back half of the year, keep in mind the typical product seasonality we expect to see in the business in the third quarter. Also, we have roughly $150 million in stocking in the second quarter, and we anticipate reversing in Q3.

讓我們來看看全年的銷售情況。今年迄今為止，我們的成長型投資組合成長了約 16%，我們預計下半年也會出現類似的成長速度。關於下半年產品銷售的階段性，請記住我們預計第三季業務中會出現的典型產品季節性。此外，我們第二季的庫存約為 1.5 億美元，預計第三季會出現逆轉。

Normalization of these dynamics next quarter will likely temper sequential growth. However, as a result of these dynamics and the strength of our underlying business, we expect strong growth across the portfolio in the fourth quarter.

下個季度這些動態的正常化可能會抑制環比成長。然而，由於這些動態和我們基礎業務的實力，我們預計第四季度整個投資組合將出現強勁成長。

And from regimen, while we continue to monitor variability from generics and other dynamic, we now expect full year sales to be at the higher end of our $4.5 billion to $5 billion sales range.

從治療方案來看，雖然我們繼續監測仿製藥和其他動態的變化，但我們現在預計全年銷售額將處於 45 億至 50 億美元銷售額範圍的高端。

In closing, we have entered the second half of 2024 with sales momentum, building in key brands and financial discipline driving a leaner and more agile organization. And as Chris said, we are excited about the long-term opportunity ahead of our emerging neuroscience platform. With the anticipated FDA approval of KarXT in September. We are committed to investing in high-growth areas where we have competitive advantages to meet the needs of our patients.

最後，我們進入了 2024 年下半年，銷售勢頭強勁，建立了關鍵品牌和財務紀律，推動組織變得更加精簡、更加敏捷。正如克里斯所說，我們對新興神經科學平台的長期機會感到興奮。 KarXT 預計將於 9 月獲得 FDA 批准。我們致力於投資具有競爭優勢的高成長領域，以滿足患者的需求。

And with that, I'll now turn the call over to Tim for Q&A.

現在，我將把電話轉給提姆進行問答。

Thanks, David. Rocco, can we go through the first question, please?

謝謝，大衛。 Rocco，我們可以回答第一個問題嗎？

(operator instructions)

（操作員說明）

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

Great. Thanks so much. Just had two quick questions here. Maybe the first one is, can you just talk about the immunology portfolio and how to think about pricing going forward? I know you mentioned that there's some modest incremental price pressure on Sotyktu given the broader access. But once that rolls out, I guess I think about the second half of this year, is that a good run rate to think about price for immunology or when we consider further access competitive environment is as a business that likely continues to see price erosion over time?

偉大的。非常感謝。只是有兩個簡單的問題。也許第一個是，您能談談免疫學產品組合以及如何考慮未來的定價嗎？我知道您提到過，鑑於更廣泛的訪問權限，Sotyktu 面臨一些適度的增量價格壓力。但一旦推出，我想我認為今年下半年，考慮免疫學價格的良好運行率，或者當我們考慮進一步進入競爭環境時，作為一家企業，可能會繼續看到價格侵蝕時間？

The second question I had was just on IRA. I know we're all kind of waiting on the price disclosure on Eliquis, but is there just directional color you can share just in terms of how negotiations we had, any surprises, just how you think about IRA price negotiations more broadly as you're thinking about the portfolio and kind of market share companion, et cetera, just as any share on that front or wish to wait till behind that disclosure, I guess in a month, but -- I appreciate it. Thank you .

我的第二個問題是關於 IRA 的。我知道我們都在等待 Eliquis 的價格披露，但是您是否可以分享一下我們的談判方式、任何意外以及您對 IRA 價格談判的更廣泛看法？的任何股票一樣，或者希望等到披露之後，我想在一個月內，但是——我很感激。謝謝 。

Thanks, Chris. Maybe I'll start with your second question then I'll flip it to Adam. So as expected, we've received the government's final in that fee price for Eliquis and as is consistent with what we've discussed previously, we anticipate CMS is going to publish the MFP price, either on or before September the first. And once that happens, we look forward to providing you more color on the impact of MFP on the shape of the Eliquis business.

謝謝，克里斯。也許我會從你的第二個問題開始，然後我會把它轉給亞當。因此，正如預期的那樣，我們已經收到了政府對 Eliquis 費用的最終價格，並且與我們之前討論的一致，我們預計 CMS 將在 9 月 1 日或之前發布 MFP 價格。一旦發生這種情況，我們期待為您提供更多關於 MFP 對 Eliquis 業務形態的影響的資訊。

What I'll say today, now that we have seen the final price, we're increasingly confident in our ability to navigate the impact of IRA on Eliquis, Eliquis is an important drug for pay that is going to continue to be an important drug for the company in the short to medium term.

我今天要說的是，既然我們已經看到了最終價格，我們對自己應對 IRA 對 Eliquis 影響的能力越來越有信心，Eliquis 是一種重要的付費藥物，並將繼續成為一種重要的藥物對於公司來說，中短期內。

If we step back from Eliquis though, I want to continue to emphasize that we firmly opposed government price-setting under IRA, we continue to believe that arbitrary price-setting by the government on life-saving medicines is not good public policy.

如果我們從 Eliquis 退一步，我想繼續強調，我們堅決反對 IRA 下的政府定價，我們仍然認為政府對救生藥物的任意定價不是好的公共政策。

So irrespective of short term dynamics, we remain very concerned about the long-term obligations of IRA on innovation, but that will be able to give you more color on Eliquis once we get that price published, which we anticipate in the coming weeks and certainly before 1, September. Adam?

因此，無論短期動態如何，我們仍然非常關注 IRA 在創新方面的長期義務，但是一旦我們公佈價格，這將能夠給您更多關於 Eliquis 的信息，我們預計在未來幾週內公佈，當然也是如此9月1日之前。亞當？

Yeah, Chris, thanks for the question. Just more broadly immunology, we noticed a highly competitive and highly rebated category, and we're may making good progress across a number of our key products. As you heard from David and Chris and I both portfolio as well as in immunology. Now, I have to acknowledged that static performance, has been slower than we'd like what we're focused on, improving that. We're executing our plan where a key focus has been on improving our access position.

是的，克里斯，謝謝你的提問。就更廣泛的免疫學而言，我們注意到競爭激烈且折扣很高的類別，並且我們可能在許多關鍵產品上取得了良好進展。正如您從大衛和克里斯那裡聽到的那樣，我和我都從事投資組合以及免疫學方面的工作。現在，我必須承認靜態效能比我們想要的要慢，我們需要改進它。我們正在執行我們的計劃，重點是改善我們的訪問位置。

As David mentioned, we're beginning to make significant progress in that area. We came into the year with 25% unrestricted access, and we had that to roughly the first half of the year. As we move into the back half of the year, essentially effective 1, July, we more than doubled that. We now have approximately 65% access, the majority of which is zero step edits. So that's about a over 100 million lives now. And we expect further access improvements in January.

正如大衛所提到的，我們開始在該領域取得重大進展。今年我們有 25% 的不受限制的訪問，並且大約在今年上半年都是這樣。當我們進入今年下半年時，基本上從 7 月 1 日開始，我們的數字增加了一倍以上。我們現在擁有大約 65% 的存取權限，其中大部分是零步驟編輯。現在大約有一億多人的生命。我們預計一月份將進一步改善存取權限。

So obviously, that's important because we'll see new patients move faster on to commercial product work to move patients quickly out of our bridge program and on a commercial product and we'll see much fewer patients treat at the specialty pharmacy. We'll also see, as David mentioned, a modest increasing gross to net due to the rebates required for improved access, offset by increased volume.

顯然，這很重要，因為我們將看到新患者更快地轉向商業產品工作，從而使患者快速脫離我們的過渡計劃並使用商業產品，並且我們將看到在專業藥房接受治療的患者數量大大減少。正如大衛所提到的，我們還將看到，由於改善訪問所需​​的回扣，毛額與淨額略有增加，但被數量增加所抵消。

As a reminder, in Q2, we had a one-time negative impact of about $6 million due to a gross-to-net true up. So you as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025. And we're committed to making this a big product for the company.

提醒一下，在第二季度，由於毛淨值的真實上漲，我們遭受了約 600 萬美元的一次性負面影響。因此，當我們以擴大的准入結束這一年時，我們將處於比今年開始時更好的位置，這將為我們進入 2025 年提供很大的動力。 。

Thanks, Adam. Rocco, could we go to the next question, please?

謝謝，亞當。 Rocco，我們可以進入下一個問題嗎？

Luisa Hector, Berenberg.

路易莎·赫克托，貝倫貝格。

Hello, Thank you for taking my questions. I just wondered whether you could describe what the 150 million stocking benefits occurred across products in Q2? And then had a question on cendakimab, so good to see the positive readout that? Could you tell us how soon you might able to file and perhaps how you competition message and in some sort of color around the access and the launch ramp to sort of piggybacking on your comments on Sotyktu. So how should we think about the potential launch that? Thank you.

您好，感謝您回答我的問題。我只是想知道您能否描述一下第二季度各產品的 1.5 億備貨效益如何？然後有一個關於 cendakimab 的問題，很高興看到積極的讀數？您能否告訴我們您多久可以提交文件，也許您如何競爭信息，並以某種顏色圍繞訪問和啟動坡道，以某種程度地利用您對 Sotyktu 的評論。那我們該如何考慮潛在的推出呢？謝謝。

Thanks, Luisa. I'll ask David to start and then from that and Adam can address the question on that.

謝謝，路易莎。我會請大衛開始，然後亞當可以回答這個問題。

So thanks for your question on the inventory, that's really in the I-O franchise across Opdivo and Yervoy. But as well, there's some in our immunology franchise at [rincey and Symposia].

感謝您提出有關庫存的問題，這實際上屬於 Opdivo 和 Yervoy 的 I-O 專營權。但同樣，我們在 [rincey 和 Symposia] 的免疫學專營權中也有一些。

Thanks, David, and thank you for the question. First on cendakimab. We have a positive Phase 3 study that read out this recently the trial that both its primary endpoints on dysphagia days as well as the eosinophilic count decrease. I'd also add the secondary endpoints, but we've just received the data in our hands.

謝謝大衛，也謝謝你提出這個問題。首先是 cendakimab。我們最近進行了一項積極的 3 期研究，該試驗顯示其吞嚥困難日的主要終點以及嗜酸性粒細胞計數均減少。我也會新增輔助端點，但我們剛剛收到手中的資料。

So we are doing a deep dive on that. And as we look at the data will, of course, take into account when the data we presented at the medical conference as well as take into account what the landscape is in terms of how patients after you today and as we have and for the next steps for us cendakimab, from a commercial perspective. Let me pass it on to Adam, who can then comment on that as well.

所以我們正在對此進行深入研究。當然，當我們查看數據時，我們會考慮到我們在醫學會議上提供的數據，以及考慮到患者今天以及我們所擁有的和下一次的情況。讓我將其轉告給 Adam，他也可以對此發表評論。

Yeah, Lisa, thank you for the question. So we're obviously pleased with the positive Phase 3 study for cendakimab, it's early days, and so we look forward to presenting the data. But just roughly, when you look in the US are about 300,000 treated patient treatment rates in here, we are pretty low in the United States in first line treatment rates around 4%. And that increases as you go down lines of therapy to third line, which about 30 patients are treated.

是的，麗莎，謝謝你的提問。因此，我們顯然對 cendakimab 的積極 3 期研究感到滿意，現在還處於早期階段，因此我們期待提供數據。但粗略地說，當你看看美國大約 30 萬名接受治療的患者的治療率時，我們在美國的一線治療率相當低，約為 4%。隨著治療線向下延伸至三線（約有 30 名患者接受治療），這一數字還會增加。

And the majority of patients are on conventional therapies like PPIs, steroids and then they are treated with Dupixent. And so as Samit mentioned, the phase or days are important for patients as also the potential for remodeling here. And this is a market where payers are managing about half of the lives in the US, so we expect in majority of lives to be position behind Dupixent. And again, we look forward to sharing data with regulatory authorities and presenting it at an upcoming meeting.

大多數患者先接受 PPI、類固醇等常規療法，然後再接受 Dupixent 治療。正如薩米特所提到的，階段或日子對病人來說很重要，這裡重塑的潛力也很重要。在這個市場，付款人管理著美國大約一半的生活，因此我們預計大多數人的生活將落後於 Dupixent。我們再次期待與監管機構分享數據，並在即將舉行的會議上展示這些數據。

Thanks, Adam. Let's go to the next question, please. Rocco.

謝謝，亞當。請讓我們進入下一個問題。羅科.

Chris Shibutani, Goldman Sachs.

克里斯·澀谷，高盛。

Good morning. Thank you very much. Chris, you and the team have been much more aggressive on the business development front over the last six to nine months, and you've had to make some really thoughtful decisions about prioritizing programs so that the cost overrun, what's your capacity now? And in particular, what's your appetite noting that historically parcel has in cardiovascular and metabolic? And just directly your question about any interest in the obesity and obesity adjacent round.

早安.非常感謝。克里斯，在過去的六到九個月裡，您和您的團隊在業務開發方面更加積極主動，您必須就計劃的優先順序做出一些深思熟慮的決定，以免成本超支，您現在的能力是多少？特別是，您注意到歷史上包裹在心血管和新陳代謝方面的作用是什麼？直接問你對肥胖和肥胖相鄰回合是否有興趣的問題。

Thank you so much.

太感謝了。

Sure. Thanks for the questions, Chris.

當然。謝謝你的提問，克里斯。

Maybe I will start and then I'll turn it over to David, who can speak to the capacity. But well as expected, we continue to prioritize business development it, Some as you point out, something that we've certainly had as a priority going back to when we did the deals at the end of last year, I would say our priority right now is to execute the deals that we completed seven months ago.

也許我會開始，然後我會把它交給大衛，他可以談談這個能力。但正如預期的那樣，我們繼續優先考慮業務發展，正如您所指出的，我們在去年年底進行交易時肯定將其作為優先事項，我想說我們的優先事項是正確的現在是執行我們七個月前完成的交易。

Notable among that is, we're actively preparing for the KarXT launch, hopefully in September, and certainly Adam can speak to that. As David also mentioned, and I would highlight that we're also focused on paying down debt as a top priority. Beyond that, though, business development and partnerships are going to be continued, continue to be important to us in terms of the types of deals that we're interested in.

其中值得注意的是，我們正在積極準備 KarXT 的發布，希望在 9 月份，Adam 當然可以對此發表演說。正如大衛也提到的，我要強調的是，我們也將償還債務視為首要任務。但除此之外，業務發展和合作夥伴關係將繼續下去，就我們感興趣的交易類型而言，這對我們仍然很重要。

Obviously, they have to make strategic and financial sense as our first order. We're going to continue to be disciplined there. As I mentioned in my prepared remarks, you saw the therapeutic areas and move realities that we're focused on and where we feel we have a right to win.

顯然，他們必須具有策略和財務意義作為我們的首要任務。我們將繼續在那裡遵守紀律。正如我在準備好的演講中提到的，您看到了我們關注的治療領域和現實，以及我們認為我們有權利獲勝的領域。

So those would be primarily the areas of focus for business development and then on the requisite question on OBC, I'll get to in a second, but there is that they also requisite question on size of deal. I would think about bolt-on deals and partnerships as being the priority for us in the immediate term.

因此，這些主要是業務發展的重點領域，然後是關於 OBC 的必要問題，我稍後會談到，但他們也有關於交易規模的必要問題。我認為補強交易和合作關係是我們近期的首要任務。

And look, we're going to continue to monitor the obesity market. But I would say with respect to business development for us right now, I would focus on those areas that I highlighted in my prepared remarks. David?

看，我們將繼續監控肥胖市場。但我想說的是，關於我們現在的業務發展，我將重點放在我在準備好的發言中強調的那些領域。大衛？

Chris, I think you covered it. Well, the only thing I'd emphasize as we think about capital allocation overall, besides the debt paydown and some we remain firmly committed to the dividend, as evidenced by us paying a dividend for the past 92 years and increasing at the last 15 years. And as you know, we have the lowest payout ratios of our peer group. So overall, we remain very financially disciplined from a capital allocation perspective.

克里斯，我想你已經涵蓋了。好吧，當我們考慮整體資本配置時，我唯一要強調的是，除了債務償還和一些我們仍然堅定地致力於股息之外，正如我們在過去92 年支付股息並在過去15 年增加股息所證明的那樣。如您所知，我們的派息率是同行中最低的。因此，總體而言，從資本配置的角度來看，我們在財務上仍然非常自律。

Thanks, David. Can we go to the next question, please, Rocco?

謝謝，大衛。羅科，我們可以進入下一個問題嗎？

Tim Anderson, Wolfe Research.

蒂姆·安德森，沃爾夫研究中心。

Thank you. Could I go back at IRA stuff for a moment, there's no formal gag order for any drug companies from talking about ongoing price negotiations. I'm told CMS has asked drug companies to keep quiet nonetheless and all the drug companies, have been complying with that, including crestal.

謝謝。我能回到愛爾蘭共和軍的事情上來嗎，沒有正式的禁言令禁止任何製藥公司談論正在進行的價格談判。我聽說 CMS 已要求製藥公司保持沉默，而所有製藥公司都遵守了這項要求，包括 Crestal。

And I'm trying to figure out why would drug companies comply with that request and really keep it quiet ahead of the coming announcement? And then second, we might actually be getting that announcement much earlier than people are thinking, possibly in the next week or so ahead of the congressional recess. If that come earlier, can we assume that you'll provide your update shortly thereafter? So, meaning possibly in the next couple of weeks if the newsroom come earlier?

我試圖弄清楚為什麼製藥公司會遵守這項要求，並在即將發布的聲明之前保持沉默？其次，我們實際上可能會比人們想像的更早宣布這一消息，可能是在國會休會前的下週左右。如果更早發生，我們是否可以假設您會在不久之後提供更新？那麼，如果新聞編輯室來得更早的話，可能會在接下來的幾週內發生？

Sure. Thanks for the questions, Tim. So first, we've been consistent that we're going to only speak to the specifics of MFD once we have the -- once we have CMS having published, which we anticipate being on or before September 1. What I'll say is once that price is disclosed, we're going to be able to provide a very good picture of the shape of the business for Eliquis going forward, inclusive of the impact of IRA. And we very much look forward to being able to provide that clarity.

當然。謝謝你的提問，提姆。因此，首先，我們一直一致認為，只有在 CMS 發布後（我們預計會在 9 月 1 日或之前發布），我們才會談論 MFD 的具體細節。好地了解Eliquis 未來的業務狀況，包括IRA 的影響。我們非常期待能夠提供這種清晰度。

And again, what I would emphasize is based on having seen the price, we're very confident in our ability to navigate the impact of IRA on Eliquis. And so again, we'll provide more details when that price becomes public. And one other point is, we will provide once that becomes public is we will announce earlier if CMS comes before September 1st and we'll put what we anticipate around IRA and its impact on our IR website, and so that's how we'll be communicating that.

再次，我要強調的是，基於看到的價格，我們對應對 IRA 對 Eliquis 影響的能力非常有信心。同樣，當價格公開時，我們將提供更多詳細資訊。另一點是，一旦公開，我們將提前宣布，如果 CMS 在 9 月 1 日之前到來，我們將把我們對 IRA 的預期及其影響放在我們的 IR 網站上，這就是我們的方式傳達這一點。

Great. Let's go to the next question, please.

偉大的。請讓我們進入下一個問題。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO 資本市場。

Hi, guys. Thank you so much for taking my question. Two for me. So Adam, can you walk me through some of the key launch preparations you're taking for the launch of KarXT that will help you capitalize on your competitive headstart?

嗨，大家好。非常感謝您回答我的問題。給我兩個。 Adam，您能否向我介紹您為推出 KarXT 所做的一些關鍵準備工作，這些準備工作將幫助您充分利用自己的競爭優勢？

And then on the IRA/trough earnings, I'm not going to push on the price, but what else do you need to know or need to have in hand to really be able to help us understand kind of when these trough earnings that we've been talking about and when you'll be able to provide kind of when that happens?

然後，關於 IRA/低谷收益，我不會推動價格，但是您還需要了解或需要掌握什麼才能真正幫助我們了解我們何時會出現這些低谷收益我們一直在談論什麼時候你能夠提供這種情況發生的時間？

Thank you guys so much.

非常感謝你們。

Sure. So why don't I let Adam start on KarXT and then I'll take your second question.

當然。那我為什麼不讓 Adam 開始使用 KarXT，然後我會回答你的第二個問題。

Yeah, Evan, thank you for the question. So we're excited about the launch of KarXT as this is a very important drug with significant commercial potential as we shared. Reminder, given a late September and Q4 launch, we effectively see this as a 2025 launch and KarXT is going to be the first innovative therapy in schizophrenia approved for decades.

是的，埃文，謝謝你的提問。因此，我們對 KarXT 的推出感到興奮，因為正如我們所分享的，這是一種非常重要的藥物，具有巨大的商業潛力。提醒一下，考慮到 9 月底和第四季度的上市，我們實際上認為這是 2025 年的上市，KarXT 將成為數十年來第一個獲得批准的精神分裂症創新療法。

So let me talk a little bit about how we are preparing for the launch. And I'll focus on a few key areas. Number one, we're sourcing a very experienced field sales and strong medical organizations to prepare the market for this new mechanism.

那麼讓我來談談我們是如何為發布做準備的。我將重點放在幾個關鍵領域。第一，我們正在尋找經驗豐富的現場銷售人員和強大的醫療組織，為這個新機製做好市場準備。

Secondly, the access team that we have, have been out there for months, reinforcing the profile with state Medicaid directors and Medicare payers. Just as a reminder, the schizophrenia market is very different in terms of access in markets that are highly PBM-driven. Government payers will be critical to building access for this product since the patient population is greater than 80% Medicaid and Medicare. We've received very positive feedback from thought leaders and payers in the space that KarXT fills a significant unmet need.

其次，我們擁有的准入團隊已經在那裡工作了幾個月，加強了州醫療補助董事和醫療保險付款人的形象。提醒一下，精神分裂症市場在高度 PBM 驅動的市場准入方面非常不同。由於患者群體佔醫療補助和醫療保險的比例超過 80%，因此政府付款人對於建立該產品的可及性至關重要。我們從思想領袖和付款人那裡收到了非常正面的回饋，認為 KarXT 填補了重大的未滿足需求。

And the third area that I'll highlight is we need to ensure that physicians and patients have a positive first experience. This is a new mechanism with a different profile and ensuring that patients stay on treatment. So overall, we're pleased to launch Readiness Efforts and we look forward to launching this important medicine later this year.

我要強調的第三個領域是我們需要確保醫生和患者有正面的初次體驗。這是一種具有不同特徵的新機制，可確保患者繼續接受治療。總的來說，我們很高興啟動準備工作，並期待在今年稍後推出這種重要的藥物。

Yeah, thank you, Adam. I just want to add a couple of things, Evan. Samit here. In addition to looking forward to the approval in September, we are also executing on the overall development plan for KarXT, as you know, adjunctive schizophrenia study as well as the Alzheimer's disease associated psycho studies are ongoing and they're enrolling well.

是的，謝謝你，亞當。我只想補充幾件事，艾文。薩米特在這裡。除了期待9月份的批准之外，我們還在執行KarXT的整體開發計劃，如你所知，輔助性精神分裂症研究以及阿茲海默症相關的心理研究正在進行中，並且招募情況良好。

We look forward to data readouts in 2025 and 2026. We anticipate initiation of the Phase 3 trials in bipolar disorder as well as Alzheimer's agitation also in 2025 with a BID dosing and then also preparing to start the Phase 3 study, Alzheimer's disease cognition impairment also in 2025.

我們期待在2025 年和2026 年公佈數據。氏症認知障礙的3 期研究2025年。

In addition to that, we are now making the preparations for the autism studies, which will include children, so we need to do some work on that, but really a large program that is being initiated and executed right now.

除此之外，我們現在正在為自閉症研究做準備，其中包括兒童，所以我們需要在這方面做一些工作，但實際上是一個大型項目，現在正在啟動和執行。

Thanks, Samit. Now Evan, going back to your question on trough.

謝謝，薩米特。現在埃文，回到你關於低谷的問題。

I'll redirect you back to the comments that I made at the beginning of the year. We've talked about navigating a period that starts in 2026. Now having said that, our focus continues to be on improving the shape of the business over time. And the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets.

我會將您帶回我在年初發表的評論。我們已經討論了從 2026 年開始的一段時間。好消息是我們有很多戰略槓桿可以利用。我們擁有不斷成長的年輕資產組合。

We saw good growth in the first half and we expect good growth in the back half. We have new products launching, notably KarXT and nivo subcu this year. Those are going to be important in terms of describing the shape of our business longer-term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026.

我們上半年看到了良好的成長，我們預計下半年也會有良好的成長。今年我們推出了新產品，特別是 KarXT 和 nivo subcu。這些對於描述我們長期業務的形式非常重要。我們擁有後期管道資產，這些資產將從今年開始，並加速到明年直至 2026 年。

And as we've discussed over time, these have considerable commercial potential. We have some very interesting early programs. We're going to start seeing proof-of-concept starting this year, notably CD19 NEX-T. And of course, as David has mentioned already today, we have a very good balance sheet and the capacity to do smart partnerships and business development.

正如我們長期以來所討論的，這些具有巨大的商業潛力。我們有一些非常有趣的早期項目。我們將從今年開始看到概念驗證，特別是 CD19 NEX-T。當然，正如大衛今天已經提到的，我們擁有非常良好的資產負債表，並且有能力進行明智的合作和業務發展。

So those are a number of the things that are obviously going to shape how this business looks in the back half of the decade. And we're fixated on delivering across the business in the short-term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the back half of the decade.

因此，這些顯然將影響該產業在本世紀後半葉的面貌。我們專注於在短期內實現整個業務的交付，並拉動我剛才提到的策略槓桿，這是加快公司在本世紀後半葉的成長時機和速度所必需的。

Let's go the next question, please. Rocco.

請讓我們進入下一個問題。羅科.

Carter Gould, Barclays.

卡特·古爾德，巴克萊銀行。

Hi. Good morning. Thanks for taking the questions. Maybe one for Adam. You had a really nice quarter in Breyanzi, you highlighted some of the drivers there. Can you maybe, you know, compartmentalize that a bit and help us think about then the second half of the year as we think about both those new indications, but also the step-up in supply? Just again given sort of the reset in 2Q, additional color here would be pretty helpful.

你好。早安.感謝您提出問題。也許是給亞當的。你在布雷揚齊度過了一個非常美好的季度，你強調了那裡的一些司機。您是否可以將其稍微劃分一下，幫助我們考慮下半年的情況，因為我們既考慮了這些新的跡象，也考慮了供應的增加？再次考慮到第二季的重置，這裡的額外顏色會非常有幫助。

Adam?

亞當？

Yeah, Carter, thank you for the question. We're pleased with Breyanzi performance in the quarter. Remember, in Q1, we said we expected significant improved manufacturing capacity and also a tailwind from our new indications. So in the second quarter, as David shared, sales increased over 50% versus prior year and we anticipate that to continue through the remainder of the year.

是的，卡特，謝謝你的提問。我們對 Breyanzi 本季的表現感到滿意。請記住，在第一季度，我們表示我們預計製造能力將顯著提高，並且我們的新適應症也將帶來推動作用。因此，正如 David 分享的那樣，第二季的銷售額比去年同期增長了 50% 以上，我們預計這種情況將持續到今年剩餘時間。

We expect continued strong growth to be driven first by our lead indication in LBCL as Breyanzi is increasingly recognized as the best-in-class CD19 as well as by our expanded indications, which are off to a very good start. We're also pleased and I want to acknowledge and thank our GPS organization with our expanded manufacturing capacity.

我們預計持續強勁的成長將首先由我們在LBCL 的領先適應症（因為Breyanzi 越來越被認為是同類最佳CD19）以及我們擴大的適應症所推動，這些適應症已經有了一個非常好的開始。我們也很高興，我想感謝我們的 GPS 組織擴大了製造能力。

We're now in a much stronger position to meet demand in the market. And so taken together our recent approvals, our expanded manufacturing capacity and best-in-class will enable us to compete much more effectively to win in this market.

我們現在在滿足市場需求方面處於更有利的地位。因此，綜合我們最近獲得的批准、擴大的製造能力和一流的水平將使我們能夠更有效地競爭，從而贏得這個市場。

Thanks, Adam. Okay. Let's go to the next question, please. Rocco.

謝謝，亞當。好的。請讓我們進入下一個問題。羅科.

Seamus Fernandez, Guggenheim Securities.

謝默斯·費爾南德斯，古根漢證券公司。

Great. Thanks for the question. So a couple of quick ones. Samit, you have a number of clinical readouts coming in multiple myeloma with your CELMoD portfolio in 2026. Just hoping you could help us understand how you see those products potentially commercially or maybe not commercially, but clinically positioned relative to the very increasingly crowded landscape that we see today.

偉大的。謝謝你的提問。所以有幾個快速的。 Samit，您的CELMoD 產品組合將在2026 年獲得許多多發性骨髓瘤的臨床數據。而言，它們的臨床定位我們今天看到了。

And then the second question actually hearkens back a little bit to IRA, but more so to Part-D redesign. Can you guys help us understand how the Part-D redesign dynamics that are likely to materially impact the substantial payout that you make on Eliquis is likely to be offset negatively by the impact of the catastrophic cap that comes in, in 2025?

第二個問題其實有點讓人回想起 IRA，但更多的是 D 部分的重新設計。你們能否幫助我們了解可能會對 Eliquis 的巨額支出產生重大影響的 Part-D 重新設計動態如何可能被 2025 年出現的災難性上限的影響所抵消？

And at what point will you seek to educate the market on those pushes and pulls in 2025? Will that fall with the IRA negotiation effects or will it fall, you know, simply with 2025 guidance? Thanks.

到 2025 年，您將在什麼時候尋求讓市場了解這些推動和拉動？這個數字會隨著 IRA 談判的影響而下降，還是因為 2025 年指引而下降？謝謝。

Samith, then Adam.

薩米斯，然後是亞當。

Yeah. Thank you, Seamus, for the question. As we think about multiple myeloma, it is a disease which has really been benefiting from multiple therapies that have been approved over the years and certainly has had transformational outcomes for these patients, including small molecules as well as large molecules and now with cell therapies and bispecifics coming into the play.

是的。謝謝西莫的提問。當我們想到多發性骨髓瘤時，這種疾病確實受益於多年來已被批准的多種療法，並且肯定為這些患者帶來了變革性的結果，包括小分子和大分子，現在有了細胞療法和雙特異性進入遊戲。

As we think about CELMoDs, as we think about Iberdomide and mezigdomide both in development across the four Phase 3 clinical trials with readouts coming in 2026. The way we think about it is multi-drug regimens will be required for these patients because ultimately right now we don't have a cure for the disease.

當我們想到CELMoD 時，當我們想到伊貝多胺和美齊格多胺都在四項3 期臨床試驗中進行開發時，讀數將於2026 年公佈。最終現在我們沒有治癒這種疾病的方法。

And that's the way we have designed the studies with mezigdomide going head-to-head versus pomalidomide, whereas if we think about iberdomide, we're looking at combinations to really change the outcomes when you combine them with velcade and dexamethasone or moving into a maintenance setting after transplant going head-to-head versus Revlimid.

這就是我們設計美齊格多胺與泊馬度胺對比研究的方式，而如果我們考慮伊伯多胺，我們正在尋找組合，以真正改變結果，當你將它們與萬卡得和地塞米松結合使用時，或將它們與泊馬度胺結合使用時。

So we believe that there are patients who are not going to be eligible to receive cell therapies where these therapies will play a role. Also, we need manageable toxicities, which don't have the same outcomes of CRS, et cetera, that are associated by specific therapies right now.

因此，我們相信有些患者沒有資格接受細胞療法，而這些療法將會發揮作用。此外，我們需要可控的毒性，這些毒性與目前與特定療法相關的 CRS 等結果不同。

So placement of these therapies will become important and we'll continue to generate more data through many other trials so that we ultimately give more our momentarium to physicians to prescribe to the right patients for better outcomes in multiple myeloma.

因此，這些療法的放置將變得非常重要，我們將繼續透過許多其他試驗產生更多數據，以便我們最終為醫生提供更多動力，為正確的患者開出處方，以獲得更好的多發性骨髓瘤治療結果。

Thanks, Samit. Seamus, before I turn it over to Adam to walk through the redesign of that specifically, I'll just say that when we give the color on MFP, that will be inclusive of all aspects of IRA, including the Part-D redesigns, get that whenever we talk about the final MFP price. But Adam?

謝謝，薩米特。 Seamus，在我將其交給 Adam 專門進行重新設計之前，我只想說，當我們在 MFP 上提供顏色時，這將包含 IRA 的所有方面，包括 D 部分重新設計，得到每當我們談論多功能一體機的最終價格時。但是亞當？

Yeah, Seamus. As you alluded to, since products are impacted differently by the Medicare redesign, we carefully evaluate each of the individual dynamics both now as well as into the future to determine the potential impacts.

是的，西莫。正如您所提到的，由於醫療保險重新設計對產品的影響不同，我們會仔細評估現在和未來的每一個動態，以確定潛在的影響。

We will see a favorability with Eliquis next year due to the Part-D redesign, notably with the elimination of the coverage gap. That'll partially be offset by Rev and Pomalyst having responsibility now in the catastrophic phase. So we're monitoring this very closely to understand what the impact is on out-of-pocket cap as well and other shifts that are happening in the landscape.

由於 Part-D 的重新設計，尤其是覆蓋範圍差距的消除，我們明年將看到 Eliquis 受到青睞。 Rev 和 Pomalyst 現在在災難階段負有責任，這將部分抵消這一影響。因此，我們正在非常密切地監控這種情況，以了解這對自付費用上限以及正在發生的其他變化有何影響。

Yeah. And just to close off on that, what I would say when we look at Part-D redesign across the entire portfolio, we actually think that it offsets and would be largely meaningful

是的。最後，當我們審視整個產品組合中的 D 部分重新設計時，我想說的是，我們實際上認為它可以抵消並且在很大程度上是有意義的

Thanks, Chris. Can we go to the next question, please?

謝謝，克里斯。我們可以進入下一個問題嗎？

Terence Flynn, Morgan Stanley.

特倫斯‧弗林，摩根士丹利。

Great. Thanks so much for taking the question. David, I was just wondering if you can provide any early commentary on how we should think about 2025 operating margins, maybe just walking us through some of the puts and takes. And then separately, I was wondering if you guys can disclose the WINREVAIR royalty from Merck? Thank you.

偉大的。非常感謝您提出問題。大衛，我只是想知道您是否可以就我們應該如何考慮 2025 年營業利潤率提供任何早期評論，也許只是引導我們了解一些看跌和看跌。另外，我想知道你們能否透露一下默克公司的 WINREVAIR 特許權使用費？謝謝。

David?

大衛？

Yeah, thanks, Terence. And look, we remain committed to our greater than 37% operating margin. And as you saw, we saw strength in our gross margins with our mix of our business. And we feel really good about the operational efficiency programs that we're executing against now, which gives us a lot of flexibility in maintaining those operating margins above 37%. Thanks, Terence.

是的，謝謝，特倫斯。看吧，我們仍然致力於實現超過 37% 的營業利潤率。正如您所看到的，我們的業務組合帶來了毛利率的強勁成長。我們對目前正在執行的營運效率計畫感到非常滿意，這為我們提供了很大的靈活性，可以將營運利潤率維持在 37% 以上。謝謝，特倫斯。

Thanks, Terence.

謝謝，特倫斯。

And about WINREVAIR, David?

大衛，關於 WINREVAIR 的事？

And WINREVAIR that, so we recognized 22% of global sales of WINREVAIR that comes through our other growth revenue that comes through there and you'll hear about those sales from Merck when they come through, but obviously an important growth driver for us is that 22% royalty rate.

WINREVAIR，所以我們認識到 WINREVAIR 全球銷售額的 22% 來自我們的其他成長收入，當這些收入來自默克時，你會聽到這些銷售，但顯然對我們來說一個重要的成長動力是22% 的特許權使用費率。

Thanks very much. David. Can we go the next one, please.

非常感謝。大衛。我們可以去下一個嗎？

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Great. Thank you very much for taking my question. And maybe one question I want to ask is like as with new launches, there are spaces you have done really well like oncology and cardiology now with Camzyos picking up, but immunology seems to be a challenge and even before Sotyktu there was Zeposia?

偉大的。非常感謝您回答我的問題。也許我想問的一個問題是，就像新推出的產品一樣，有些領域你做得非常好，比如腫瘤學和心臟病學，現在隨著Camzyos 的崛起，但免疫學似乎是一個挑戰，甚至在Sotyktu 之前就有Zeposia？

So just want to understand, what are the excess dynamics that you are finding challenging versus your expectations going in? I'm asking because with some of those IL-23s and all, they have found better access than what we are seeing with Sotyktu. So could you please help us understand that? Thank you.

所以只是想了解一下，與您的期望相比，您發現的具有挑戰性的過度動態是什麼？我之所以這麼問，是因為他們發現了比我們在 Sotyktu 上看到的更好的訪問權限，其中一些 IL-23 等等。那麼您能幫助我們理解這一點嗎？謝謝。

Thanks, Mohit. Good question. And Adam, you'll take it.

謝謝，莫希特。好問題。亞當，你會接受的。

Sure, Mohit. Thanks for the question. So as we talked about, we are focused on continuing to accelerate our growth portfolio. As you saw in the quarter, we're making good progress there. We're delivering strong performance for products like Reblozyl, Camzyos, Breyanzi and Opdualag.

當然，莫希特。謝謝你的提問。因此，正如我們所說，我們專注於繼續加速我們的成長投資組合。正如您在本季度所看到的，我們在這方面取得了良好進展。我們為 Reblozyl、Camzyos、Breyanzi 和 Opdualag 等產品提供強大的效能。

As I talked about, Sotyktu performance is slower than we would like and we are focused on improving both performance and execution. But ultimately, it's the access there that has taken longer than we expected. Remember, in many of the immunology categories that we compete in, these are highly controlled, highly managed products by the large PBMs.

正如我所說，Sotyktu 的效能比我們希望的要慢，我們專注於提高效能和執行力。但最終，訪問那裡的時間比我們預期的要長。請記住，在我們參與競爭的許多免疫學類別中，這些產品都是大型 PBM 高度控制、高度管理的產品。

And so it took longer for us to get into a preferred position based on entrenched contracts. And so as we're seeing uptake now, we're in a much better position with approximately 65% access with most of that is at zero step edit. And that's going to be really important.

因此，我們花了更長的時間才根據既定合約獲得了優先地位。因此，正如我們現在所看到的那樣，我們處於一個更好的位置，大約有 65% 的存取權限，其中大部分是零步驟編輯。這將非常重要。

So we recognize this is a highly competitive market and we're continuing to make improvements and we expect further improvements in access in January. As it relates to Zeposia, Zeposia has really been a tale of two launches.

因此，我們認識到這是一個競爭激烈的市場，我們正在繼續做出改進，我們預計一月份的訪問權限將進一步改善。就 Zeposia 而言，Zeposia 實際上是兩次發布的故事。

We entered the market in multiple sclerosis and we've seen good uptake there over time and we're doing that in a market that continues to contract based on the kind of the increases in the products like Ocrevus and Kesimpta and we continue to grow our share in a competitive market. Now UC has been more challenging. It is more managed, it's more managed class.

我們進入了多發性硬化症市場，隨著時間的推移，我們看到了那裡的良好吸收，我們在一個隨著Ocrevus 和Kesimpta 等產品的增加而不斷收縮的市場中做到這一點，我們繼續發展我們的產品在競爭市場中分享份額。現在UC變得更具挑戰性。它更受管理，更受管理的班級。

TNFs have preferred status across virtually all of the PBMs, but we're also focused on making progress there as well. So I think it's hard to paint immunology in general with a broad brush. Orencia continues to perform well, no biosimilar insight.

TNF 在幾乎所有 PBM 中都享有優先地位，但我們也致力於在這方面取得進展。所以我認為很難用粗略的方式概括免疫學。 Orencia 繼續表現良好，沒有生物相似藥洞察力。

And finally, as we talked about, we're ready for the launch of KarXT, which has very different access dynamics than what's in the immunology space today. So we are continuing to make progress in delivering strong performance and execution and we're confident in our ability to continue to grow our business in the near term and into the longer term.

最後，正如我們所討論的，我們已準備好推出 KarXT，它的訪問動態與當今免疫學領域的訪問動態截然不同。因此，我們將繼續在提供強勁的業績和執行力方面取得進展，並且我們對在短期和長期內繼續發展業務的能力充滿信心。

Thanks, Adam. Let's go to the next question, please.

謝謝，亞當。請讓我們進入下一個問題。

Amit Hazan, Leerink Partners.

阿米特·哈贊 (Amit Hazan)，Leerink 合夥人。

Yes, thanks very much, and congrats on the performance.

是的，非常感謝，並祝賀你們的表現。

So two questions, please. First is, with respect to IRA, many companies, including Bristol have suggested it's not too much of a problem. And so I'm just helping, I'm hoping that you could help us understand a little bit how you're thinking about drugs that aren't rebated today like Part B drugs such as Opdivo and their risk of price pressure when they're negotiated relative to drugs that are heavily rebated today like Eliquis.

那麼有兩個問題請教。首先，就 IRA 而言，包括布里斯託在內的許多公司都表示這並不是什麼大問題。所以我只是提供幫助，我希望您能幫助我們了解一下您對今天不回扣的藥物（如 Opdivo 等 B 部分藥物）的看法，以及它們在上市後面臨價格壓力的風險。 （Eliquis）這樣大幅折扣的藥物，我們重新進行了談判。

So if you could just comment on that, that would be helpful. And then second, with respect to some of your growth drivers, obviously, you've kind of commented a lot on Sotyktu and Opdualag, but there are competitors that have shown some pretty encouraging data and competitors claim and in some cases, i.e., with respect to Sotyktu, they're running head-to-head trials that their drugs are going to show much better efficacy cross-trial than Sotyktu and Opdualag and launch late decade. So if you could just comment on that and how you're thinking about the future competition? Thanks so much.

因此，如果您能對此發表評論，那將會很有幫助。其次，關於您的一些成長驅動因素，顯然，您對 Sotyktu 和 Opdualag 發表了很多評論，但有些競爭對手已經顯示了一些非常令人鼓舞的數據，並且競爭對手聲稱在某些情況下，即就Sotyktu而言，他們正在進行頭對頭試驗，他們的藥物將在交叉試驗中顯示出比Sotyktu 和Opdualag 更好的療效，並在十年後推出。那麼您能否對此發表評論以及您如何看待未來的競爭？非常感謝。

Thanks, David. I'll let Adam address certainly the first question and actually probably the second question as well. But let me just first say, we're not going to speculate on the impact of products that have not been or aren't planned to be negotiated. Adam can speak generally about how we manage the different books of business between Medicare and commercial. But Adam?

謝謝，大衛。我會讓 Adam 解決第一個問題，實際上也可能解決第二個問題。但我首先要說的是，我們不會猜測尚未或不計劃進行談判的產品的影響。 Adam 可以概括地談論我們如何管理醫療保險和商業之間的不同業務帳簿。但是亞當？

Yeah. I mean, I think we're a long way off to 2028. So I agree, I think it's premature to discuss if Opdivo would be eligible even for IRA negotiation. Remember, if Opdivo makes the list, there could be generics in the market or biosimilars in the market as well. But I think most importantly is what you heard from both David and Chris is that we announced a PDUFA date for our nivo subcu in late December.

是的。我的意思是，我認為距離 2028 年還有很長的路要走 所以我同意，我認為現在討論 Opdivo 是否有資格參加 IRA 談判還為時過早。請記住，如果 Opdivo 進入名單，市場上可能會有仿製藥或生物相似藥。但我認為最重要的是，您從 David 和 Chris 那裡聽到的是，我們宣布了 12 月底的 nivo subcu 的 PDUFA 日期。

So our goal is to convert as much business as we can well prior to the LOE. And we expect to convert at least 30% to 40% of the total US business for Opdivo ahead of the LOE and we think this is a great opportunity for both physicians and patients and we look forward to launching this important formulation. Also, with a biosimilar in the market and we don't expect to see Opdivo completely fall off either.

因此，我們的目標是在 LOE 之前盡可能轉化業務。我們預計在 LOE 之前將 Opdivo 美國業務總量的至少 30% 至 40% 轉化為 Opdivo，我們認為這對醫生和患者來說都是一個很好的機會，我們期待推出這項重要的製劑。此外，隨著生物相似藥上市，我們預計 Opdivo 也不會完全下滑。

So we also expect to see the subcu and the IV continue into the next decade as well. As it relates to the competition in immunology or in PSO, I think, more specifically as you're asking, again, we are preparing for competition there. I think Sotyktu has set a high bar for new orals in the PSO space.

因此，我們也預期 subcu 和 IV 也會在下一個十年繼續存在。由於它與免疫學或 PSO 領域的競爭有關，我認為，更具體地說，正如您所問的那樣，我們正在為那裡的競爭做準備。我認為 Sotyktu 為 PSO 領域的新口語表達設定了很高的標準。

This is a very competitive category today. It's only going to become more crowded and more competitive over time. We also plan to have several indications, including PSA by -- we'll see some data by the end of this year, which will help both PSO and help accelerate Sotyktu as well as SLE, both of which SLE and PSA will be approved and will read out at that time.

如今，這是一個競爭非常激烈的類別。隨著時間的推移，它只會變得更加擁擠、競爭更加激烈。我們還計劃有幾個跡象，包括 PSA，我們將在今年年底看到一些數據，這將有助於 PSO 並有助於加速 Sotyktu 以及 SLE，SLE 和 PSA 都將獲得批准，並且到時候就會閱讀出。

So we're going to have to see the results of the study. The oral IL-23 Phase 3 data would need to be meaningfully different in order to move the needle, but we're continuing to make progress with Sotyktu and executing our plan and we focus on growing this important brand.

所以我們必須看到研究結果。為了取得進展，口服 IL-23 第 3 期數據需要有意義的不同，但我們將繼續與 Sotyktu 取得進展並執行我們的計劃，我們專注於發展這個重要的品牌。

And I think I'll just add because I think you also mentioned, David, Opdualag. And as far as Opdualag is concerned, once again, we are way ahead with melanoma indication already approved in the first line, anticipating the data for the adjuvant melanoma, anticipating also the presentation of the Phase 2 data soon and then initiation of the Phase 3 program in the subset of non-small cell lung cancer to continue the progress. Rest of the data that we've seen from the competition is just too small to really interpret anything out of that.

我想我會補充一下，因為我想你也提到過，大衛，Opdualag。就 Opdualag 而言，我們再次領先於已經在第一線獲得批准的黑色素瘤適應症，預計輔助黑色素瘤的數據，預計很快會出現 2 期數據，然後啟動 3 期數據非小細胞肺癌亞型的計劃繼續取得進展。我們從比賽中看到的其餘數據太小，無法真正解釋其中的任何內容。

Thanks so much. Can we go to the next question, please, Rocco?

非常感謝。羅科，我們可以進入下一個問題嗎？

Steve Scala, SG Cowen.

史蒂夫·斯卡拉，SG 考恩。

Thank you very much. Chris, I apologize for being picky, but you said two times on the call that Bristol would give visibility on the contour of Eliquis business around September 1st, but you didn't say floor guidance. And when you were specifically asked about floor guidance, you repeated something from earlier in the call. So is floor guidance no longer in the plans? And secondly, Samit on cendakimab in EoE.

非常感謝。克里斯，我為我的挑剔道歉，但你在電話中兩次表示，布里斯托爾將在 9 月 1 日左右提供 Eliquis 業務輪廓的可見性，但你沒有說樓層指導。當您被特別詢問樓層指南時，您重複了先前通話中的內容。那麼樓層引導不再在計畫中了嗎？其次，Samit 在 EoE 中使用 cendakimab。

So Dupixent showed 60% of patients achieved histologic remission at 24 weeks. Is cendakimab fully competitive with that? You sound very confident. So it sounds like yes. And historically, your tone in saying things like this has been very predictive. So I'm just curious what to make of it. Thank you.

因此 Dupixent 顯示 60% 的患者在 24 週時達到組織學緩解。 cendakimab 是否完全具有競爭力？聽起來你很有信心。所以聽起來是的。從歷史上看，你說這樣的話的語氣非常具有預測性。所以我只是好奇該怎麼做。謝謝。

Thanks, Steve. I'll start and then I'll turn it over to Samit. So look, we know there's a lot of interest in this topic around floor guidance. As I've said before, in general, we've moved away from providing long-term targets. This actually reflects us going back to what the company has done historically.

謝謝，史蒂夫。我先開始，然後把它交給薩米特。所以看，我們知道大家對樓層指導這個主題很有興趣。正如我之前所說，總的來說，我們已經不再提供長期目標。這實際上反映了我們回到公司歷史上所做的事情。

That said, we continue to increase our confidence in the long-term growth profile of this business. We're going to continue to provide updates to you on that business as appropriate and we'll be transparent about how we see the business evolving.

也就是說，我們持續增強對該業務長期成長前景的信心。我們將繼續酌情向您提供有關該業務的最新信息，並且我們將對業務發展的看法保持透明。

And as for how we do that and when we do that, as I think most of you are aware, our normal practice is to provide forward-looking guidance at the beginning of the year, normally when we report our Q4 results, and we're going to continue with that process. Samit?

至於我們如何做到這一點以及何時做到這一點，我想你們大多數人都知道，我們的正常做法是在年初提供前瞻性指導，通常是在我們報告第四季度業績時，我們'我們將繼續這個過程。薩米特？

Thank you. And thanks for the question, Steve. As always, very pointed one. Look, we did do the study as it relates to comparison versus Dupixent. So it's very hard to start comparing the data. Also remember the way the dysphagia days, which is a more important and most important thing from a symptom relief for the patient. The way we measured it versus what Dupixent did in their study are very different ways. So we have to keep that in mind.

謝謝。謝謝你的提問，史蒂夫。一如既往，非常尖銳的一個。看，我們確實做了這項研究，因為它與 Dupixent 的比較有關。所以很難開始比較數據。也要記住吞嚥困難日子的方式，這對患者來說是更重要、最重要的症狀緩解。我們測量它的方式與 Dupixent 在他們的研究中所做的方式非常不同。所以我們必須牢記這一點。

Certainly will not comment on the specificity of the data because we would rather present it at a medical conference or to come on that. Certainly, as mentioned earlier by Adam as well, we look to the data deeply and put it into perspective as we go forward also in communications with the regulators.

當然不會對數據的特殊性發表評論，因為我們寧願在醫學會議上展示它或參加會議。當然，正如 Adam 之前提到的，我們會深入研究數據，並在與監管機構溝通時正確看待這些數據。

Let's go to the next question, please, Rocco.

讓我們進入下一個問題，羅科。

Charles Young, UBS.

查爾斯楊，瑞銀集團。

Good morning, guys. Trung Huynh from UBS. I have a few follow-ups on the subcu Opdivo. So today you highlighted again the 30% to 40% conversion. How quickly are you arriving at this 30% to 40% of patients? What's stopping it from being more as we've seen things like Darzalex have quite significant conversion?

早上好傢伙。瑞銀 (UBS) 的 Trung Huynh。我對 subcu Opdivo 有一些後續行動。今天您再次強調了 30% 到 40% 的轉換率。您要多快才能到達這 30% 到 40% 的患者？當我們看到像 Darzalex 這樣的東西有相當大的轉換時，是什麼阻止了它的發展？

And then, when is the exclusivity expected to last for this subcu versus IV given the somewhat recent CMS drafts on IRA on subcu formulations? I think you mentioned in one of the questions the next decade, but do you have a year? Thank you.

然後，考慮到最近關於 subcu 配方的 IRA 的 CMS 草案，這種 subcu 相對於 IV 的排他性預計何時持續？我想你在一個問題中提到了未來十年，但是你有一年嗎？謝謝。

Adam?

亞當？

Yeah, Trung, thanks for the question.

是的，Trung，謝謝你的提問。

So again, as I said, we are looking forward to the PDUFA date in late December and our launch planning is continuing to progress. So we said we have converted at least 30% to 40% of the total US Opdivo IV business. And we have -- the good news is we have time because the LOE is not until 2028. So we expect that conversion to come largely from patients who are in the adjuvant setting, use in combination with Yervoy where there is continuing Opdivo treatment, for example, indications in metastatic melanoma in first-line RCC as well as in Opdivo monotherapy.

正如我所說，我們再次期待 12 月底的 PDUFA 日期，而我們的發布計劃正在繼續取得進展。所以我們說我們已經轉換了美國Opdivo IV業務總量的至少30%到40%。好消息是我們有時間，因為 LOE 要到 2028 年才能實現。藥物治療中轉移性黑色素瘤的適應症。

These indications represent approximately 70% of our overall business. And so we talked about the benefits of nivo subcu has the potential to benefit both patients with a less than five-minute infusion time and physicians who are able to free-up chairs, particularly in the community setting.

這些跡象約占我們整體業務的 70%。因此，我們討論了 nivo subcu 的好處，它有可能使輸液時間少於五分鐘的患者和能夠騰出椅子的醫生受益，特別是在社區環境中。

And we do have the potential to benefit patients through the next decade with nivo subcu based on the fact that we've got a broad patent estate. So we expect to see both nivo subcu and Opdualag continue to persist our leading IO franchise into the early 2030s.

基於我們擁有廣泛的專利權，我們確實有潛力在未來十年透過 nivo subcu 使患者受益。因此，我們預計 nivo subcu 和 Opdualag 將繼續保持我們領先的 IO 特許經營權直至 2030 年代初。

Thanks, Adam. Let's go to the next question, please?

謝謝，亞當。讓我們進入下一個問題，好嗎？

Matthew Fields, William Blair.

馬修·菲爾茲，威廉·布萊爾。

Thanks for taking my questions. Two quick ones on Phase 3 trials. Wondered if recruitment has recommenced in the ACTION-1 trial with RZ101 and Actinium supply is secured there. And then on the successor trials with mezigdomide, it looks like the trials have advanced to Part 2 of the Phase 3. Wondering if you can give us any sense of the dose that was taken from Part 1 into Part 2? Thank you.

感謝您回答我的問題。第三階段試驗中有兩個快速的。想知道 RZ101 的 ACTION-1 試驗中是否重新開始招募，錒供應是否有保障。然後在美齊格多胺的後續試驗中，看起來試驗已經進入了第 3 階段的第 2 部分。謝謝。

Matt, I think Matt, from it, thank you for both the questions for the actinium two to five study. As you know, we are the furthest along in terms of directing them to do five Phase three trial of GAAP. Net is the first indication with a strong data supporting it .

馬特，我想馬特，謝謝你提出的關於錒二到五研究的兩個問題。如你所知，我們在指導他們進行 5 個 GAAP 第三階段試驗方面走得最遠。 Net是第一個有強而有力數據支持的跡象。

We have reinitiated the recruitment in the trial, and we are still looking forward to the data readout in 2026, along with certain looking forward to new indications, starting with such a small cell lung cancer Phase one trial that is already ongoing far music that might drive again, enrollment is continuing, and we will not yet declared what that does. We've taken forward. But certainly, yes, both trials and move to the part two of the study. And you continue to hear about how the drug progresses and we are looking forward to the readout starting in 2026.

我們已經重新啟動了試驗招募，我們仍然期待 2026 年的數據讀出，同時也期待一些新的適應症，從這樣一個小細胞肺癌開始的一期試驗已經在進行中了。繼續，我們尚未宣布其用途。我們已經向前邁進了。但當然，是的，這兩項試驗都進入了研究的第二部分。您將繼續了解該藥物的進展情況，我們期待 2026 年開始的結果。

Thanks, Helen. Let's go to the next question, please.

謝謝，海倫。請讓我們進入下一個問題。

Olivia Breyer, Cantor Fitzgerald.

奧利維亞·布雷耶，康托·菲茨杰拉德。

Hi, good morning, and thank you for the question. I wanted to ask a follow-up on Sotatercept. It looks like you guys changed your other income guidance by about $200 million for the year. So is that essentially entirely from the Sotatercept launch?

你好，早安，謝謝你的提問。我想問 Sotatercept 的後續情況。看起來你們今年的其他收入指引改變了大約 2 億美元。那麼這基本上完全是來自 Sotatercept 的推出嗎？

Obviously, a big number there if you back it out based on a 22 -- or a 22% royalty rate. And then how are you thinking about Sotatercept's contribution to your P&L going forward just given the strong economics there? And one more, just can you also comment on level of enthusiasm around your PRMT5 program and what we'll see from the Phase-1 readout in the back half of the year? Thank you.

顯然，如果你根據 22 或 22% 的特許權使用費率來支持的話，這是一個很大的數字。那麼考慮到那裡強勁的經濟狀況，您如何看待 Sotatercept 對您未來損益的貢獻？另外，您能否評論一下 PRMT5 計劃的熱情程度以及我們將從今年下半年的第一階段報告中看到的內容？謝謝。

David and Samit?

大衛和薩米特？

Yeah, Olivia, thanks for the question. The O&E increase was mainly driven by two things, as I said earlier in my prepared remarks, which is the diabetes royalties coming in better than we had anticipated as well as interest expense coming in better than anticipated.

是的，奧利維亞，謝謝你的提問。正如我之前在準備好的發言中所說，O&E 成長主要由兩件事推動，即糖尿病特許權使用費的成長好於我們的預期，以及利息支出的成長好於預期。

And what I was saying earlier related to WINREVAIR, since we still own the intellectual property of that, that 22% of global sales related to the product goes through our other growth revenue line. So it comes through sales.

我之前所說的與 WINREVAIR 有關，因為我們仍然擁有該產品的智慧財產權，所以與該產品相關的全球銷售額的 22% 來自我們的其他成長收入線。所以它是透過銷售來實現的。

And thank you, Olivia, for the question on PRMT5. Certainly, again, very much further along on that one. Phase 1 trial continues on. What we will be presenting data is the responses that have been seen across multiple different tumor types.

謝謝 Olivia 關於 PRMT5 的問題。當然，再一次，我們在這方面已經走得更遠了。第一階段試驗仍在持續。我們將提供的數據是在多種不同腫瘤類型中觀察到的反應。

So really looking forward to presenting that data as we plan to initiate the Phase 2 studies in a couple of indications, which we will talk about more as we get closer to the initiation of those trials in selected patients, of course, with MTAP deletions.

因此，我們非常期待在我們計劃啟動幾個適應症的2 期研究時提供這些數據，當我們接近在選定的患者中啟動這些試驗時，我們將更多地討論這些數據，當然，還有MTAP刪除。

Thanks. And let's go to the next one, please. Rocco,

謝謝。請讓我們進入下一個。羅科,

Steve Chesney, Redburn Atlantic.

史蒂夫·切斯尼，雷德本大西洋月刊。

Yeah, great. Thank you. Maybe just a follow-up on radiopharma, please. With regard to the commercial opportunity for RYZ101 and GEP-NET, I wonder how competitor filings of an ANDA and a 505(b)(2) for Lutathera impacts your thinking on pricing for innovators in the space?

很好。謝謝。也許只是放射性藥物的後續行動。關於 RYZ101 和 GEP-NET 的商業機會，我想知道競爭對手提交的 ANDA 和 Lutathera 的 505(b)(2) 申請如何影響您對該領域創新者定價的看法？

And then also on KarXT, we've seen a couple of competitor data sets over the past month or two that showed relapses at a fairly early time point and somewhat lower-than-expected response rates. Just wondering how you guys have been thinking about that as it relates to KarXT, whether you have more confidence in your construct or are you doing something differently on dosing? Thank you.

然後還在 KarXT 上，我們在過去一兩個月看到了幾個競爭對手的數據集，這些數據集顯示在相當早期的時間點復發，並且響應率略低於預期。只是想知道你們如何看待與 KarXT 相關的問題，你們是否對自己的構建更有信心，或者你們在劑量方面是否做了不同的事情？謝謝。

Adam, then Samit

亞當，然後是薩米特

Yeah, first, let me just talk about our enthusiasm about RayzeBio and the platform that we have here. We believe this is a really exciting platform, one that's going to grow significantly through the back end of the decade.

是的，首先，讓我談談我們對 RayzeBio 和我們在這裡擁有的平台的熱情。我們相信這是一個非常令人興奮的平台，它將在本世紀末顯著增長。

And what particularly excites us about Rayze is the kind of robust IND engine that we'll see over the course of the next decade or plus as well as what we know is a state-of-the-art manufacturing facility that has been forward.

Rayze 特別讓我們興奮的是我們將在未來十年或更長時間內看到的那種強大的 IND 引擎，以及我們所知道的最先進的製造設施。

Now the lead program in RYZ101 in GEP-NET is, I think, a fairly modest commercial opportunity. However, when you look at this technology, particularly the Actinium-based radiopharmaceutical platform, this has the potential to have efficacy and safety across a host of solid tumor treatments.

我認為，現在 GEP-NET 中 RYZ101 的主導計畫是一個相當適度的商業機會。然而，當您觀察這項技術，特別是基於錒的放射性藥物平台時，您會發現它有可能在許多實體腫瘤治療中發揮功效和安全性。

So as we've talked about, we are looking at this in small-cell lung cancer and potentially many other tumor types. So we look forward to launching the GEP-NET indication that will be the lead asset and well -- as well as a number of new INDs coming in the back half of the decade and beyond.

正如我們所討論的，我們正在小細胞肺癌和許多其他腫瘤類型中研究這一點。因此，我們期待推出 GEP-NET 適應症，這將成為主要資產，以及在本世紀後半段及以後推出的許多新 IND。

Yeah. And thank you, Adam. And just to talk about CD19 NEX-T there are a couple of things to understand. Number one, we have two studies ongoing. The first study enrolls patients not only with far advanced systemic lupus erythematosus, but also systemic sclerosis as well as myositis. The second study is enrolling patients with multiple sclerosis.

是的。謝謝你，亞當。就 CD19 NEX-T 而言，有幾件事需要理解。第一，我們正在進行兩項研究。第一項研究不僅招募了晚期系統性紅斑狼瘡患者，也招募了系統性硬化症和肌炎患者。第二項研究正在招募多發性硬化症患者。

Now it's very important to understand the profile of the patients that are being enrolled. These are patients who have far advanced disease. They are on glucocorticoids, immunosuppressants, immunomodulators. And these patients may also have underlying organ dysfunction such as renal failure and kidney damage.

現在了解正在招募的患者的概況非常重要。這些患者的病情已處於晚期。他們服用糖皮質激素、免疫抑制劑、免疫調節劑。而這些患者還可能有潛在的器官功能障礙，如腎衰竭、腎損傷等。

So as we think about the impact of these single-infusion CAR-cell therapies, what are we trying to achieve? We're trying to achieve a remission in the sense that patients can go off of their treatments such as glucocorticoids and immunosuppressants.

因此，當我們思考這些單次輸注 CAR 細胞療法的影響時，我們想要實現什麼目標？我們正在努力實現緩解，即患者可以停止使用糖皮質激素和免疫抑制劑等治療。

What one does not expect at this time at least that we can revert the damaged kidney to a normal state because kidney doesn't grow by itself. So I think we have to keep that in mind as we look at the data and we're looking forward to bring that data as we look to the presentation of these patients that we are treating today.

目前人們沒有想到的是，至少我們可以將受損的腎臟恢復到正常狀態，因為腎臟不會自行生長。因此，我認為我們在查看數據時必須牢記這一點，並且我們期待在查看我們今天正在治療的這些患者的表現時提供這些數據。

Thanks. And let's go to the next one, please?

謝謝。讓我們進入下一個，好嗎？

James Shin, DB

詹姆斯·辛，DB

Good morning, guys. Thanks for taking the questions.

早上好傢伙。感謝您提出問題。

A couple more on the pipeline. Just to piggyback on PRMT5 readout later this year, can you shed some light on the data size, which data points to expect? And are you thinking this will be disclosed via conference setting? And then similar to that about CD19 NEX-T, how will that be read out?

還有更多正在醞釀。借用今年稍後的 PRMT5 讀數，您能否透露一下數據大小以及預期的數據點？您認為這會透過會議形式揭露嗎？然後類似CD19 NEX-T，如何讀出？

And then I think another question, our previous question talked about some of the negotiation dynamics in immunology. A lot of these CDMs are getting into biosimilars. Has that changed negotiation dynamics at all in your early interactions? Thank you.

然後我想到另一個問題，我們之前的問題談到了免疫學方面的一些談判動態。許多 CDM 正在進入生物相似藥領域。這是否改變了你們早期互動中的談判動態？謝謝。

Samit and Adam.

薩米特和亞當。

Yeah. And I think your question, you're breaking up a bit, James. I think you were asking about disclosure for? (multiple speakers)

是的。我認為你的問題是，你們有點分手了，詹姆斯。我想你問的是披露的目的？ （多個發言者）

Yeah. So both of these molecules, we are looking forward to presenting the data this year, certainly through a medical conference for both of them. For PRMT5, all the patients that have been enrolled, we are looking forward to bring the dose overall safety and where we've seen responses.

是的。因此，我們期待今年提供這兩種分子的數據，當然是透過針對這兩種分子的醫學會議。對於 PRMT5，我們期待為所有已入組的患者提供該劑量的整體安全性以及我們所看到的反應。

And certainly, that will be the data that we will be presenting. For KarXT, we're looking forward to presentation of the data for certainly SLE at an upcoming conference as well and then grow from there. We are obviously preparing and planning to have conversations with regulatory authorities as well to plan for later stages of development of this molecule.

當然，這將是我們將提供的數據。對於 KarXT，我們期待在即將舉行的會議上展示 SLE 的數據，然後從那裡開始發展。顯然，我們正在準備併計劃與監管機構進行對話，並為該分子的後期開發制定計劃。

Yeah. Just quickly on the biosimilar question, as I mentioned, in UC, yes, biosimilars do have a preferred position in first-line. However, in respect to the PSO market, we are continuing to work with payers to understand the dynamics there.

是的。正如我所提到的，在 UC 中，生物相似藥的問題很快就解決了，是的，生物相似藥在一線確實具有優先地位。然而，就 PSO 市場而言，我們正在繼續與付款人合作，以了解那裡的動態。

But we have not heard or seen PBMs move to a biosimilar first approach. The reason for that largely is the fact in PSO, products like Humira and Stelara do not have a dominant position in that space. So we would not expect biosimilars, at least in the near term to take on a preferred position.

但我們還沒有聽說或看到 PBM 轉向生物相似藥優先方法。造成這種情況的主要原因是在 PSO 領域，Humira 和 Stelara 等產品在該領域並不佔據主導地位。因此，我們預計生物相似藥至少在短期內不會佔據優先地位。

Thanks, Adam. Let's go to the next one, please.

謝謝，亞當。請讓我們進入下一個。

Kripa Devarakonda, Truist Securities.

Kripa Devarakonda，Truist 證券公司。

Yes. Thank you so much for taking my question and congrats on a quarter performance and one question on Canada as maybe a question and I for 10 days in terms of patient advocates for quite a key focus, starting to see a little bit of acceleration in the last couple of quarters.

是的。非常感謝您提出我的問題，並祝賀我的季度表現和一個關於加拿大的問題，這可能是一個問題，我在患者倡導者方面花了10 天的時間來關注相當重要的焦點，在過去的時間裡開始看到一點加速幾季。

Is that just trying to partake in steady-state getting this, it's just noise or could this be a trend going forward are standing on increase on uptake on? And the other thing on IRA is actually a little bit more futuristic. Maybe do you see any potential impact on our implementation depending on the value of the November the election? Could there be any change? Thank you.

這是否只是試圖參與穩態，這只是噪音，或者這可能是未來的趨勢，吸收率不斷增加？ IRA 的另一件事實際上更具未來感。也許您認為 11 月選舉的價值對我們的實施有任何潛在影響嗎？能有什麼改變嗎？謝謝。

So Adam, and then I'll take your IRA question.

亞當，然後我將回答你的 IRA 問題。

Kripa, yeah, thanks for the question. And we've seen steady and consistent growth from Camzyos. And as David mentioned, we saw approximately 1,300 patient increase on commercial drug quarter-over-quarter. We expect that to be steady and consistent growth over time. Physician and patient feedback continues to remain very positive.

Kripa，是的，謝謝你的提問。我們已經看到 Camzyos 的穩定和持續成長。正如 David 所提到的，我們看到使用商業藥物的患者比上一季增加了約 1,300 名。我們預計隨著時間的推移，這一增長將保持穩定和持續的成長。醫生和患者的回饋仍然非常積極。

Our focus is increasing our user base, both in the large COEs, while also increasing breadth of prescribing in some of the smaller institutions and some of the larger community practices. In fact, we'll be deploying additional community representatives.

我們的重點是擴大大型 COE 的用戶群，同時擴大一些小型機構和一些大型社區診所的處方範圍。事實上，我們將部署更多的社區代表。

These are Eliquis representatives into the community of cardiology account to drive treatment. So we're seeing good momentum with Camzyos and we're pleased with the performance of this very important product.

這些是 Eliquis 代表進入心臟病學領域推動治療。因此，我們看到 Camzyos 的良好勢頭，我們對這款非常重要產品的性能感到滿意。

And I know we're running over time maybe for two more here. So maybe go to the next one, please.

我知道我們可能已經超時了，可能還需要兩個。那麼請轉到下一篇。

Sean McCutcheon, Raymond James.

肖恩麥卡琴，雷蒙德詹姆斯。

Hey, guys. Thanks for taking over it -- thank you for taking my question. Maybe one for Samit. So we're going to get the Oceanic AF data at ESC in about a month. Obviously, Librexia AF is ongoing and time will tell if there are any distinctions from the rapid failure we saw for Asundexian.

大家好。感謝您接管它——感謝您提出我的問題。也許是給薩米特的。因此，我們將在大約一個月後在 ESC 獲得海洋 AF 數據。顯然，Librexia AF 仍在繼續，時間會告訴我們與我們看到的 Asundexian 的快速失敗是否有任何區別。

But and likely insufficient dose-finding in Pacific as noted, but what are the specifics you're looking for read through on the mechanism for those data? And do you see any risk to getting data that come in that clearly shows sufficient inhibition of Factor XIa activity, do you have a detriment on stroke prevention? Thanks.

但是，如前所述，太平洋地區的劑量發現可能不足，但是您正在尋找有關這些數據機制的具體細節是什麼？您認為獲得明確顯示充分抑制因子 XIa 活性的數據有任何風險嗎？謝謝。

And before Samit answers, I just want to address the second part of Kripa's question just very quickly around patient. Obviously, we're going to continue to follow the election in the United States, it's difficult to speculate on how things will change from a policy standpoint with any given administration just simply because it's not just a Presidential Election, but it's also you have to look at the composition of Congress. So I think we're just going to have to continue to pay attention to this over time. But Samit, do you want to address?

在薩米特回答之前，我只想圍繞患者快速解決克里帕問題的第二部分。顯然，我們將繼續關注美國的選舉，很難從任何特定政府的政策角度推測情況將如何變化，因為這不僅僅是總統選舉，你還必須看看國會的組成。所以我認為隨著時間的推移，我們將不得不繼續關注這一點。但是薩米特，你想講話嗎？

Yeah. Thank you. Thank you for the question as well. Look, I think let's start off with the first fact that when we started the Milvexian program, it was based on the prior learnings from the Phase 2 studies. That's why we chose the doses that we chose that for a single agent at a higher dose of 100 milligrams BID, whereas the 25 milligram BID where there was a background of antiplatelet agents.

是的。謝謝。也謝謝你的提問。聽著，我想讓我們從第一個事實開始，當我們開始 Milvexian 計劃時，它是基於先前從第二階段研究中獲得的知識。這就是為什麼我們選擇單一藥物的劑量為 100 毫克 BID，而 25 毫克 BID 則有抗血小板藥物的背景。

Second, independent investigators have now conducted preclinical work to show the differentiation between Asundexian versus Milvexian, showing the inhibition and the time it takes and the doses that are required for real inhibition of Factor XIa. And so that gives us a little bit more confidence in terms of how things are going -- are shaping up.

其次，獨立研究人員現已進行臨床前工作，以顯示 Asundexian 與 Milvexian 之間的差異，顯示抑製作用、所需時間以及真正抑制因子 XIa 所需的劑量。因此，這讓我們對事情的進展更有信心。

Third, for AF, secondary stroke prevention as well as ACS, the enrollment continues very well in these three trials and we're looking forward to those readouts. Last thing I would say is when the data are presented, we certainly would like to see the number of events that happened, what time they happened and the impact of the dose that was used that will all be very helpful as we think about Milvexian.

第三，對於心房顫動、中風二級預防以及 ACS，這三項試驗的入組情況持續良好，我們期待這些結果。我要說的最後一件事是，當提供數據時，我們當然希望看到發生的事件的數量、發生的時間以及所使用劑量的影響，當我們考慮 Milvexian 時，這些都將非常有幫助。

Great. Thanks. And let's go to the last one, please, Rocco.

偉大的。謝謝。請讓我們進入最後一個，羅科。

Alex Hammond, BofA.

亞歷克斯·哈蒙德，美國銀行。

Hey, guys. Thanks for squeezing me in. So following Camzyos' strong performance this quarter and the REMS registry data at ACC. Can you set expectations for potential REMS modification moving forward? And do you think having the results from the ODYSSEY study reading out early next year will provide a favorable time to reengage with the FDA? Thank you.

大家好。感謝您邀請我加入。您能否對未來可能進行的 REMS 修改設定預期？您認為 ODYSSEY 研究結果明年初公佈將為您與 FDA 重新接觸提供有利時機嗎？謝謝。

Samit.

薩米特。

So I think as -- thank you for the question, as both David and Adam said earlier, thousands of patients have now been treated with Camzyos and certainly, we've learned a lot and we see the manageable profile here as well as the transformational outcomes that these patients have and stay on treatment for a very long time with 80% of the patients being treated with 2.5 and 5 milligram doses.

所以我認為- 謝謝你提出的問題，正如David 和Adam 之前所說，現在已有數千名患者接受了Camzyos 治療，當然，我們學到了很多東西，我們在這裡看到了可管理的情況以及變革性的成果這些患者的結果並長期接受治療，其中 80% 的患者接受 2.5 毫克和 5 毫克劑量的治療。

We continue our conversations with the FDA. I will not get into the specifics. And certainly now that we have pulled in the readout of the non-obstructive hypertrophic cardiomyopathy study about six months in with a readout now expected in 2Q next year, we will certainly have multiple engagements with the FDA on that front as well.

我們繼續與 FDA 對話。我不會詳細介紹。當然，現在我們已經獲得了大約六個月後的非阻塞性肥厚型心肌病變研究的結果，目前預計將在明年第二季度公佈結​​果，我們肯定也會在這方面與 FDA 進行多次接觸。

Thanks, Samit. So before we close the call, maybe I'll just leave you all with a few things. We are pleased with the performance of the business and in particular, the growth portfolio performance where revenues grew nicely in the first half and now represent, as David said earlier, 46% of the total business.

謝謝，薩米特。因此，在我們結束通話之前，也許我會留給大家一些事情。我們對業務表現感到滿意，特別是成長投資組合的表現，上半年收入成長良好，正如 David 之前所說，現在佔總業務的 46%。

At the same time, our pipeline continues to advance with new medicines and we look forward to important catalysts coming up like the KarXT launch and a number of data readouts in the coming months. So overall, I'd say we've executed well in the quarter.

同時，我們的新藥研發管線繼續推進，我們期待著重要的催化劑的出現，例如 KarXT 的推出以及未來幾個月的大量數據讀數。總的來說，我想說我們在本季執行得很好。

We feel good about the full year and are raising our outlook accordingly. It's certainly going to be a busy back half of the year and we're focused as a team and as a company on driving strong execution. So thank you all for your time today and the Investor Relations team is certainly available to answer any follow-up questions that you may have. Have a nice weekend.

我們對全年的情況感覺良好，並相應提高了我們的前景。下半年肯定會很忙碌，作為一個團隊和一家公司，我們將專注於推動強有力的執行力。感謝大家今天抽出寶貴的時間，投資人關係團隊當然可以回答您可能提出的任何後續問題。祝你周末愉快。

Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.

謝謝你，先生。今天的電話會議到此結束。我們感謝大家參加今天的演講。您現在可以斷開線路並度過美好的一天。