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.

大家好，歡迎參加百時美施貴寶 2024 年第二季財報電話會議。（操作員指示）請注意，今天的活動正在被記錄。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，早安。感謝您今天上午參加我們的 2024 年第二季財報電話會議。今天早上與我一起發表準備好的發言的還有董事會主席兼執行長 Chris Boerner；以及我們的財務長大衛·埃爾金斯（David Elkins）。參加今天電話會議的還有我們的首席商業化官 Adam Lenkowsky 和我們的首席醫療官兼全球發展主管 Samit Hirawat。

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

正如您所注意到的，我們已將幻燈片發佈到 bms.com，您可以使用它來關注 Chris 和 David 的演講。

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，我將宣讀我們的前瞻性聲明。在本次電話會議中，我們可能會對公司未來計畫和前景做出前瞻性陳述。由於各種重要因素（包括公司向美國證券交易委員會提交的文件中討論的因素），實際結果可能與這些前瞻性陳述所示的結果有重大差異。這些前瞻性陳述代表了我們截至今天的估計，不應被視為代表我們對任何未來日期的估計。#

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.

我們明確表示不承擔更新前瞻性聲明的任何義務，即使我們的估計發生變化。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的 GAAP 指標的對帳表可在 bms.com 上查閱。

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

說完這些，我就把麥克風交給克里斯。

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，我們的第二季業績反映了我們為 BMS 實現長期可持續成長而製定的策略的持續進展。在第二季度，我們持續加強商業表現，許多行銷產品的吸收都在加速。

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%，若不計外匯影響則成長 21%。這項投資組合有望在未來成為我們整體投資組合中更重要的組成部分。我們也推進了我們的產品線，展示了我們產品組合的實力以及我們首創或一流資產的開發，其中包括美國監管機構對 Breyanzi、Krazati 和 Augtyro 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 特許經營權還取得了許多里程碑，包括在歐洲獲得一線膀胱癌治療的批准、在 Asco 上展示一線肝癌治療的數據，並且正在研發更方便的 nivolumab 皮下製劑，目前我們已從美國 FDA 獲得了 12 月 29 日的生產日期。EMA 也正在審查我們的 subcu 申請。

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.

在我們進一步了解季度業績的細節之前。在第五張投影片上，我想回顧我們公司的現況以及未來的發展方向。如前所述，我們正致力於重塑 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，我們將投資組合重點放在我們具有競爭優勢的轉化藥物上，這意味著我們將盡可能地推進、加速我們在治療領域的首創或最佳治療方法，優先考慮具有有意義增長潛力的管道資產，並停止不再滿足我們投資回報門檻的項目。透過這些行動，我們確保我們的研發工作集中在 BMS 有權獲勝的項目上，並且我們可以為股東提供令人信服的投資回報率。

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，我們正在積極推動整個組織的卓越運營，包括簡化營運流程、使組織專注於最重要的事項，提高營運效率、提高研發效率、推動形成一種強調速度和責任的文化。我們正在實施成本削減措施，並有望實現第一季宣布的 15 億美元成本節約目標。

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我們投資於我們的成長投資組合和最重要的通路資產、業務發展和合作夥伴關係，這對我們仍然很重要，我們繼續加強我們的資產負債表，保持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.

總的來說，這些行動確保我們專注於整個組織的最高價值活動，在需要時加強我們的執行，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.

關於這一點，轉到幻燈片 6，我們實現頂級成長的目標要求我們充分發揮我們的產品線潛力，在血液腫瘤學領域，我們透過擴展 I-O 業務並擴大我們的關注範圍以包括細胞療法和蛋白質降解劑來推動領導地位，我們還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 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。在免疫學領域，我們將研發重點放在利用細胞療法中潛在的變革性方案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，接著是神經退化性疾病領域令人興奮的研發管線，這些管線正在繼續順利進展。

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.

在第 7 張投影片上，讓我向您具體介紹 KarXT 的進展。我們有兩個主要目標：為即將推出的產品做準備，並根據強大的臨床計劃執行，以擴大這種重要治療方法在多種適應症中的應用。KarXT 預計將於 9 月底獲得 FDA 批准，我們正在迅速建立必要的基礎設施。

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非常興奮。亞當可以在問答環節中詳細介紹我們的發布準備。如前所述，我們也正在將 KarXT 擴展到其他適應症，預計 2025 年將獲得輔助性精神分裂症的數據，2026 年將獲得阿茲海默症精神病的數據。我們針對阿茲海默症和躁鬱症進行試驗的計畫正在順利進行中。

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

最後，我們也已開始規劃該產品的兩種新適應症，即自閉症譜系障礙和阿茲海默症認知。

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.

在第 8 張投影片上，我想強調今年我們治療領域的一些重要里程碑。在血液腫瘤學領域，我們正在透過 nivolumab 皮下注射和 Opdualag 的肺部數據擴展我們的 I-O 特許經營權。隨著預計在今年底推出的 nivolumab 皮下製劑，我們繼續估計至少 30% 至 40% 的美國接受靜脈注射治療的患者將在多種適應症中轉而採用更方便的皮下給藥。這最終將使患者在未來十年受益於標準的癌症治療。

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.

我們計劃很快與 Opdualag 分享第二階段概念驗證資料。這支持在今年稍後啟動針對一線非小細胞肺癌患者亞群的 3 期研究。在免疫學中，我們今年將看到 CD19 NEX-T 的數據。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。我們還完成了針對 SOTYKTU 和銀屑病關節炎的兩項 3 期試驗的招募，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.

展望第 9 張投影片，我們將在今年下半年開始看到我們管道的重要數據讀數，並將在 2026 年之前保持強勁勢頭。需要重點關注的包括肺纖維化中的 LPA1、我們的註冊多發性骨髓瘤管線，包括 GPRC5D 細胞療法和我們的 Golcadomide、Iberdomide Mezigdomide，當然還有無疫苗，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重大利益並為公司帶來巨大的商業機會。隨著通路建設勢頭的增強，我們有信心進一步加強我們的成長動能。

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.

讓我以第 10 張投影片上的展望作為結束。鑑於我們第二季業績的強勁表現以及我們對今年剩餘時間的信心，我們現在預計營收成長將達到預期範圍的上限。我們也上調了全年每股收益的預期範圍。

David will discuss these updates in more detail shortly.

David 很快就會詳細討論這些更新。

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.

總結一下，在第二季度，我們 在推動長期持續成長的道路上邁出了顯著的一步。雖然還有更多工作要做，但我們正在透過推進富含催化劑的管道、擴大我們的商業組合和保持具有戰略靈活性的強勁資產負債表來加強這一增長的基礎。我要感謝 BMS 員工在本季度做出的貢獻以及他們致力於以更快的速度向更多患者提供突破性藥物。

Let me now hand it over to David.

現在我把它交給大衛。

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.

我將從第 12 張投影片開始介紹我們的季度銷售業績亮點。首先，我要簡單提醒一下，除非另有說明，所有比較都是從 2023 年同期進行的，銷售增長率將在基本基礎上討論，不包括外匯的影響、所有對我們的損益表的引用或非 GAAP 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，包括成長投資組合成長 21% 和傳統投資組合成長 3%。成長產品組合在總銷售額中所佔的比例持續增加，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.

本季的支出優於預期，反映了我們專注於推動卓越營運和支出時機，從而使營業利潤率略高於約 40%，這些結果支持了我們對 2024 年的積極展望和我們更新的財務指引。

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.

我們第二季在主要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。雖然我們的免疫學業務取得了成長，但我們認識到還有更多工作要做，特別是在這個競爭激烈的類別中 Sotyktu 的情況。

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.

本季度，一些成長品牌的庫存也有所增加，並且淨好感度有所提高，這對於下半年銷售時需要考慮的重要因素。讓我們仔細看看我們的主要品牌表現，從幻燈片 13 上的腫瘤學特許經營開始。

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。與上一季相比，全球銷售額受到需求推動而上升，且與美國客戶購買模式相關的預期收益為 6,500 萬美元。隨著核心適應症的成熟，我們預計今年的成長率將達到中等個位數，並且我們正在等待更多的監管行動，包括預計 10 月份 FDA 對周圍輔助肺癌的批准，而我們的 I-O 特許經營權隨著 Opdualag 的進一步加強，該藥物又實現了一個季度的兩位數增長，這主要得益於需求的增加。

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，我們看到幾個新興市場的令人鼓舞的趨勢，並將繼續專注於確保報銷。正如我們之前所說，我們正在進一步開發 Opdualag 在肺癌一線治療領域的應用，並且我們仍計劃在今年稍後啟動第 3 階段註冊計劃，這些擴展機會加上即將獲得批准的 nivolumab，將進一步支持我們的 I-O 特許經營權在下一個十年的延伸。

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，第 14 頁，我認為 Eliquis 仍然是全球抗凝血劑市場的領先者，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。與第二季度的典型情況一樣，由於患者開始進入醫療保險覆蓋範圍，美國銷售額反映了不利的毛利與淨利影響。需要提醒的是，這些動態在下半年會更加明顯，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.

談到 Camzyos，第二季的銷售額比去年同期成長了兩倍多。因此，美國的銷售主要受需求推動。美國第二季度的需求主要源於第一季以來增加的約 1,300 名商業配藥患者，使商業藥品患者總數達到近 6,900 名，這一增長表明採用該藥物的現象穩定且持續。美國以外地區的銷售成長反映了報銷時機和市場改善，而在全球範圍內，我們看到未來巨大的成長空間。

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.

讓我們翻到第 15 張投影片上的「血液學」。Reblozyl 本季的銷售額成長了 82%，美國和國際市場均實現了成長。在美國，銷售受益於第一線 MDS 相關貧血症帶來的需求成長和一些有利的庫存毛利與淨利比。

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.

在美國以外，該品牌已在約 40 個國家獲得批准，包括最近在歐洲和日本推出的寬標籤品牌。我們期待看到第一線適應症在全球範圍內得到報銷。在細胞療法方面，我們看到季度間的銷售額有所成長，積壓訂單主要來自美國以外地區。我們繼續透過與客戶討論我們的 KarMMa-3 來努力解決多發性骨髓瘤領域的競爭動態。

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 本季成長了 55%，這得益於多種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，轉到第 16 張投影片上的免疫學。Sotyktu 的業績持續受到競爭環境和美國商業准入品質的影響。同時，在第二季度，我們無需任何步驟編輯，就實現了跨多個大型 PBM 的商業訪問改進。從本月初開始，我們添加了另一個大型 PBM，正如我們上個季度所討論的那樣。我們現在有超過 60% 的受保人享有優惠待遇。

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，我們預計短期內收入成長將面臨適度的總收入對淨收入的壓力，但隨著時間的推移，需求的成長將抵消這種壓力。

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，翻到第 17 張投影片，我將重點放在損益表的一些組成部分。除了穩健的商業執行之外，我們第二季度的業績還反映了我們對財務紀律的關注以及我們在上個季度的電話會議上討論的 15 億美元成本節約計劃的穩步進展。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，以產生更大的患者影響並加速我們在未來五年的銷售成長。

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.

本季毛利率表現良好，主要得益於產品組合。不包括在研發在內的營業費用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約所抵銷。從環比來看，由於計劃投資支出的時間轉移到第三季度，因此支出低於預期。

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.

本季的稅率從去年同期的 16.9% 變為 14.1%，這主要是由於釋放了所得稅儲備。本季每股總收益為 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，轉到第 18 頁的資產負債表和資本配置重點。我們的成長和傳統投資組合在本季度都實現了穩健的收入成長，傳統投資組合繼續為我們約 23 億美元的強勁營運現金流做出貢獻，我們於 6 月 30 日結束本季度，我們手頭上有約 70 億美元的現金、現金等價物和可銷售債務證券。

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.

在第二季度，我們將總債務減少了 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，這些舉措與我們在未來兩年內償還約 100 億美元債務的計劃一致。在資本配置方面，我們優先考慮那些能夠進一步加強我們長期成長前景的機會，同時繼續致力於我們的股息。

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 來了解我們指導的詳細資訊。就第二季的業績表現而言，整個業務的重點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引提供了支持。按照我們的慣例，我們根據報告基礎和基本基礎提供收入指導，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.

我們對全年收入的預期目前是低個位數成長，目前我們預計收入將達到該範圍的上限。這是由於我們的成長產品組合持續表現良好且 Revlimid 的銷售量優於預期。

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.

對於毛利率，我們正在上調預期，以反映銷售組合的影響。除收購的在研項目外，我們繼續預期總營運費用將處於低個位數百分比增幅範圍的上限，這反映了與近期收購相關的增量成本，但部分被我們提高生產力舉措所實現的節約所抵消。鑑於第二季預期支出的時間延遲，我們現在預計第三季支出將會增加。整體而言，我們之前全年營業利潤率至少 37% 的目標保持不變。

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，我們現在預計年度支出約為 5000 萬美元，因為預計特許權使用費高於預期且淨利息支出有利。年度稅率會受到當期取得的在研費用等一次性不可抵扣費用的影響，從而影響到我們第一季的非公認會計準則淨收入。

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.

除此影響外，預計全年基礎稅率仍為 18% 左右，由於這些變化，我們將 2024 年非 GAAP EPS 預期範圍上調至 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.

讓我們來看看全年銷售的分階段情況。今年迄今，我們的成長投資組合成長了約 16%，我們預計下半年的成長率也將相似。關於下半年產品銷售的分階段，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，預計第三季將出現逆轉。

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減緩連續的成長。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實現強勁成長。

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，但我們目前預計全年銷售額將達到 45 億美元至 50 億美元的銷售範圍的高端。

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，我們已經進入 2024 年下半年，銷售勢頭強勁，關鍵品牌建立和財務紀律推動組織更加精簡和敏捷。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非常興奮。預計 FDA 將於 9 月批准 KarXT。我們致力於投資我們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。羅科，我們可以先討論第一個問題嗎？

(operator instructions)

（操作員指令）

Chris Schott, JPMorgan.

摩根大通的克里斯·肖特 (Chris Schott)。

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。我只想問兩個問題。也許第一個問題是，您能否談談免疫學產品組合以及如何考慮未來的定價？我知道您提到過，鑑於更廣泛的訪問權限，Sotyktu 會面臨適度的增量價格壓力。但一旦推出，我想想想今年下半年，這是否是一個考慮免疫學價格的良好運行率，或者當我們考慮進一步獲取競爭環境時，作為一個業務，隨著時間的推移，價格是否可能繼續下降？

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，但您能否分享一些方向性的信息，比如我們的談判情況如何，是否有任何意外，您如何更廣泛地看待 IRA 價格談判，比如您正在考慮投資組合和市場份額夥伴等等，就像任何這方面的股票一樣，或者希望等到披露之後，我想在一個月內，但 - 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。也許我會先回答你的第二個問題，然後再轉給亞當。因此，正如預期的那樣，我們收到了政府對 Eliquis 的最終費用價格，並且與我們之前討論的一致，我們預計 CMS 將在 9 月 1 日或之前公佈 MFP 價格。一旦發生這種情況，我們期待為您提供有關 MFP 對 Eliquis 業務形態的影響的更多詳情。

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，我們對應對 IRA 對 Eliquis 的影響的能力越來越有信心，Eliquis 是一種重要的付費藥物，並且在短期至中期內將繼續成為公司的重要藥物。

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.

然而，如果我們放棄 Eliquis，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命藥品的任意定價並不是好的公共政策。

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 對創新的長期義務，但一旦我們公佈價格，這將能夠為您提供有關 Eliquis 的更多詳細信息，我們預計這將在未來幾週內，當然是在 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，我們注意到一個競爭激烈且回扣很高的類別，我們可能在許多關鍵產品上取得良好進展。正如您從戴維和克里斯那裡聽到的，我既在投資組合中，也在免疫學領域。現在，我必須承認，靜態效能比我們所希望的要慢，我們正在關注這一點並加以改進。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。我們今年的不受限制訪問權限為 25%，並且大約在上半年我們就達到了這一水平。隨著我們進入下半年，基本上從 7 月 1 日起，我們的數字已經增加了一倍以上。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。因此現在生命人數已超過 1 億人。我們預計 1 月份訪問情況將進一步改善。

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，因為我們會看到新患者更快地轉向商業產品工作，從而使患者迅速脫離我們的橋樑計劃並轉向商業產品，並且我們會看到在專科藥房接受治療的患者數量會大大減少。正如戴維所提到的那樣，我們還將看到，由於改善訪問所需​​的回扣，毛收入與淨收入將適度增加，但將被交易量的增加所抵消。

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，由於總收入與淨收入的對比變化，我們遭受了約 600 萬美元的一次性負面影響。因此，當我們在今年結束時，隨著我們擴大了訪問權限，我們將比今年開始時處於更好的地位，這將為我們邁向 2025 年提供巨大的動力。我們致力於將其打造成公司的一款暢銷產品。

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

謝謝，亞當。羅科，我們可以進入下一個問題嗎？

Luisa Hector, Berenberg.

路易莎·赫克托（Luisa Hector），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。我只是想知道您是否可以描述一下第二季度跨產品的 1.5 億備貨效益是什麼？然後對 cendakimab 產生了疑問，很高興看到積極的讀數？您能否告訴我們您什麼時候能夠提交文件，以及您如何在入口和發射坡道周圍提供競爭信息，以便利用您對 Sotyktu 的評論。那麼，我們該如何看待這次潛在的發布呢？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。我會請戴維開始，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].

感謝您關於庫存的問題，這實際上是 Opdivo 和 Yervoy 的 I-O 特許經營權。但在我們的免疫學專營中也有一些[rincey 和 Symposia]。

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，謝謝你的提問。首先是 cendakimab。我們有一個積極的第三階段研究，該研究最近讀到了這項試驗，其主要終點是吞嚥困難天數以及嗜酸性粒細胞計數的下降。我還會添加次要端點，但我們剛剛收到了數據。

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.

因此我們正在對此進行深入研究。當我們查看數據時，當然會考慮我們在醫學會議上展示的數據，也會考慮今天患者的情況以及我們從商業角度對 cendakimab 下一步行動的展望。讓我把它轉交給亞當，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，我們對 cendakimab 的 3 期研究的積極結果感到非常高興，現在還處於早期階段，因此我們期待著展示數據。但粗略地看，當你看到美國大約有 30 萬名接受治療的患者的治療率時，你會發現美國的一線治療率相當低，約 4%。隨著治療線下降到第三線，治療人數不斷增加，約有 30 名患者接受第三線治療。

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 (Samit) 所提到的，階段或天數對患者來說很重要，因為這裡重塑的潛力也很重要。在這個市場上，付款人管理著美國大約一半的生命，因此我們預計大多數人的生命都會落後於 Dupixent。我們再次期待與監管機構分享數據並在即將召開的會議上展示。

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

謝謝，亞當。請我們進入下一個問題。洛可。

Chris Shibutani, Goldman Sachs.

高盛的 Chris Shibutani。

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，過去六到九個月裡，你和你的團隊在業務發展方面更加積極，你必須對優先考慮的項目做出一些深思熟慮的決定，以免成本超支，你現在的產能是多少？特別是，您認為歷史上包裹在心血管和代謝方面有何特徵？並且直接詢問您對肥胖症和肥胖症相關問題的興趣。

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，自從去年年底我們達成交易以來，我們就一直把這作為優先事項，我想說，我們現在的首要任務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，希望能在九月推出，亞當當然可以談談這一點。正如大衛所提到的，我想強調的是，我們也把償還債務當作首要任務。除此之外，就我們感興趣的交易類型而言，業務發展和合作夥伴關係仍將繼續，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，它們必須具有策略和財務意義，這是我們的首要任務。我們將繼續嚴守紀律。正如我在準備好的演講中提到的那樣，你們看到了我們關注的治療領域和發展現實，以及我們認為我們有權贏得勝利的領域。

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 的必答問題，我馬上就會講到，但他們也必答關於交易規模的問題。我認為附加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?

我們將繼續監測肥胖市場。但我想說，就我們目前的業務發展而言，我將重點放在我在準備好的發言中所強調的那些領域。戴維？

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，我想你已經講清楚了。好吧，當我們考慮整體資本配置時，我唯一要強調的是，除了償還債務之外，我們仍然堅定地致力於分紅，這一點可以從我們過去 92 年一直支付股息並且在過去 15 年不斷增加看出。如您所知，我們的派息率是同行中最低的。因此整體而言，從資本配置的角度來看，我們仍然保持嚴格的財務紀律。

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.

提姆·安德森，沃爾夫研究公司。

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。我可以稍微回顧一下 IRA 的事情嗎，目前還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。儘管如此，我聽說 CMS 還是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?

我想弄清楚為什麼製藥公司會遵從這項要求並在即將發布的公告之前保持沉默？其次，我們實際上可能會比人們想像的更早收到這項公告，可能是在國會休會前的下週左右。如果時間提前了，我們是否可以假設您會在隨後不久提供更新？那麼，如果新聞編輯室來得早一點的話，可能在接下來的幾週內嗎？

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。首先，我們一直堅持，一旦 CMS 發布，我們才會談論 MFD 的具體細節，我們預計 CMS 將在 9 月 1 日或之前發布。我想說的是，一旦披露價格，我們將能夠很好地描繪出 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澄清。

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.

再次強調，基於看到的價格，我們非常有信心能夠應對 IRA 對 Eliquis 的影響。因此，當價格公開時，我們會提供更多詳細資訊。另一點是，一旦資訊公開，我們會提前宣布，如果 CMS 在 9 月 1 日之前推出，我們會把我們對 IRA 的預期及其影響放在我們的 IR 網站上，這就是我們傳達訊息的方式。

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

偉大的。請我們進入下一個問題。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (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。對我來說是兩個。那麼亞當，您能否向我介紹一下為推出 KarXT 而進行的一些關鍵發布準備工作，這些準備工作將幫助您充分利用競爭先機？

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，但您還需要知道什麼或需要掌握什麼才能真正幫助我們了解我們一直在談論的這些低谷收益何時出現，以及當這種情況發生時您何時能夠提供信息？

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。那我為什麼不讓亞當開始討論 KarXT，然後我再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 的推出感到非常興奮，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，鑑於該藥物將於 9 月底和第四季度推出，我們實際上將其視為 2025 年推出，並且 KarXT 將成為幾十年來首個獲批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.

那麼讓我稍微談談我們如何為發布做準備。我將重點討論幾個關鍵領域。首先，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來為這種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，我們的准入團隊已經在那裡工作了好幾個月，並向州醫療補助主管和醫療保險支付方加強了宣傳。需要提醒的是，在高度受 PBM 驅動的市場中，精神分裂症市場在進入方面有很大不同。由於患者人數超過醫療補助和醫療保險的 80%，因此政府付款人對於建立該產品的管道至關重要。我們收到了該領域思想領袖和付款人的非常正面的回饋，認為 KarXT 滿足了重大未滿足需求。

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.

我要強調的第三個面向是，我們需要確保醫生和患者有正面的首次體驗。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。我只想補充幾點，艾文。這裡是薩米特 (Samit)。除了期待9月份的批准之外，我們還在執行KarXT的整體發展計劃，如你所知，輔助精神分裂症研究以及阿茲海默症相關的精神病研究正在進行中，而且招募情況良好。

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 2025 年和 2026 年的數據讀數。我們預計在 2025 年啟動針對躁鬱症和阿茲海默症躁動症的 3 期試驗，採用 BID 劑量，然後準備在 2025 年開始針對阿茲海默症認知障礙的 3 期研究。

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，該研究將包括兒童，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，目前正在啟動和執行。

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

謝謝，薩米特。現在，埃文，回到你關於槽的問題。

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.

我將讓你回顧我今年年初所發表的評論。我們討論過如何度過 2026 年開始的一段時期。話雖如此，我們的重點仍然是隨著時間的推移改善業務狀況。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。我們今年推出了新產品，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。我們擁有後期管線資產，這些資產從今年開始啟動，並將在明年和 2026 年加速發展。

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.

正如我們一直以來所討論的，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，尤其是 CD19 NEX-T。當然，正如大衛今天已經提到的，我們擁有非常好的資產負債表，並且有能力進行明智的合作夥伴關係和業務發展。

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.

所以這些顯然將影響未來五年該業務發展前景的因素。我們專注於短期內實現整個業務的目標，同時發揮我剛才提到的策略槓桿作用，這些槓桿對於加快公司在下一個十年的後半段的成長時間和速度是必要的。

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

請討論下一個問題。洛可。

Carter Gould, Barclays.

巴克萊銀行的卡特·古爾德。

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.感謝您回答這些問題。也許有一個是給亞當的。您在布雷揚齊 (Breyanzi) 度過了一個非常愉快的季度，您強調了那裡的一些驅動因素。您能否將其稍微分類，並幫助我們思考下半年的情況，因為我們既要考慮這些新跡象，也要考慮供應的增加？再次考慮到第二季的重置，這裡的額外顏色將會非常有幫助。

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。記住，在第一季度，我們曾表示，我們預計製造能力將顯著提高，新適應症也將帶來推動作用。因此，正如 David 所說，第二季的銷售額比去年同期成長了 50% 以上，我們預計這種趨勢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，持續強勁成長將首先得益於我們在 LBCL 中的領先適應症，因為 Breyanzi 越來越被認可為同類最佳的 CD19，同時也得益於我們擴大的適應症，這已經有了一個非常好的開端。我們也很高興，我想承認並感謝我們的 GPS 組織擴大了我們的製造能力。

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.

我們現在更有能力滿足市場需求。因此，結合我們最近獲得的批准、擴大的生產能力和一流的水平，我們將能夠更有效地競爭並贏得這個市場。

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

謝謝，亞當。好的。請我們進入下一個問題。洛可。

Seamus Fernandez, Guggenheim Securities.

古根漢證券公司的謝默斯‧費爾南德斯 (Seamus Fernandez)。

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。簡單說幾個。薩米特，2026 年，您的 CELMoD 產品組合中將有多個關於多發性骨髓瘤的臨床讀數。只是希望您能幫助我們了解您如何看待這些產品的商業潛力或非商業潛力，但相對於我們今天看到的日益擁擠的市場環境，其臨床定位。

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，但更多是涉及 Part-D 的重新設計。你們能否幫助我們理解，D 部分重新設計的動態可能會對您在 Eliquis 上獲得的巨額賠付產生重大影響，而 2025 年災難性上限的影響可能會對此產生負面影響？

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.

那麼，在 2025 年的什麼時候，您會試著讓市場了解這些推拉因素呢？這個數字是否會隨著 IRA 談判的影響而下降，或者是否僅僅因為 2025 年的指導而下降？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 Seamus 提出這個問題。說到多發性骨髓瘤，這種疾病確實受益於多年來已獲批准的多種療法，並且無疑為這些患者帶來了變革性的結果，其中包括小分子和大分子，現在還有細胞療法和雙特異性藥物發揮作用。

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.

當我們考慮 CELMoD 時，我們會考慮伊貝多胺和美齊格多胺，這兩種藥物都處於四期 3 期臨床試驗的開發階段，結果將於 2026 年公佈。我們的想法是，這些患者需要採用多種藥物治療方案，因為目前我們還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.

這就是我們設計研究的方式，將美齊多胺與泊馬度胺進行正面交鋒；而如果我們考慮伊伯多胺，我們正在研究組合，以真正改變將其與萬珂和地塞米松相結合的結果，或者將其與來那度胺進行正面交鋒，以在移植後進入維持治療環境時真正改變結果。

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，有些患者可能不適合接受細胞療法，但這些療法卻能發揮作用。此外，我們需要可控的毒性，這些毒性不會產生與目前特定療法相關的 CRS 等相同的結果。

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，這些療法的實施將變得非常重要，我們將繼續透過許多其他試驗產生更多數據，以便最終為醫生提供更多動力，為合適的患者開出處方，從而治療多發性骨髓瘤並獲得更好的療效。

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。西莫斯，在我將話題轉交給亞當來具體介紹重新設計之前，我只想說，當我們為 MFP 賦予顏色時，它將包含 IRA 的所有方面，包括 D 部分的重新設計，每當我們談論最終的 MFP 價格時都會提到這一點。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，西莫斯。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個單獨動態，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 D 部分的重新設計，尤其是消除了覆蓋範圍差距，我們將看到明年 Eliquis 的青睞。這將部分抵消 Rev 和 Pomalyst 目前在災難階段所承擔的責任。因此，我們正在密切監視這種情況，以了解其對自付費用上限的影響以及情況中發生的其他變化。

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，我想說的是，當我們審視整個投資組合的 D 部分重新設計時，我們實際上認為它能夠抵消損失，並且具有很大的意義

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.

摩根士丹利的特倫斯弗林 (Terence Flynn)。

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。非常感謝您回答這個問題。大衛，我只是想知道您是否可以就我們應該如何看待 2025 年的營業利潤率提供任何早期評論，也許只是向我們介紹一些利弊。然後另外，我想知道你們是否可以披露默克公司的 WINREVAIR 特許權使用費？謝謝。

David?

戴維？

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。而且，我們仍然致力於維持 37% 以上的營業利潤率。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，這為我們維持 37% 以上的營運利潤率提供了很大的靈活性。謝謝，特倫斯。

Thanks, Terence.

謝謝，特倫斯。

And about WINREVAIR, David?

還有 WINREVAIR 的情況，大衛？

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.

至於 WINREVAIR，我們確認 WINREVAIR 全球銷售額的 22% 來自於我們的其他成長收入，當默克的銷售額實現時，您會聽到有關這些銷售額的消息，但顯然對我們來說一個重要的增長動力是 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。請問我們可以去下一個嗎？

Mohit Bansal, Wells Fargo.

富國銀行的莫希特·班薩爾 (Mohit Bansal)。

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，就像新產品的推出一樣，你們在一些領域做得非常好，例如腫瘤學和心臟病學，現在 Camzyos 正在興起，但免疫學似乎是一個挑戰，甚至在 Sotyktu 之前就有 Zeposia 了？

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，您發現哪些多餘的動態具有挑戰性？我之所以問這個問題，是因為對於一些 IL-23 來說，他們發現了比我們在 Sotyktu 上看到的更好的訪問權限。那麼你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，Mohit。好問題。亞當，你會接受它的。

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。正如我們所說，我們專注於繼續加速我們的成長組合。正如您在本季度看到的，我們在那裡取得了良好的進展。我們為 Reblozyl、Camzyos、Breyanzi 和 Opdualag 等產品提供了強勁的性能。

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，到達那裡所花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，這些都是由大型 PBM 嚴格控制和管理的產品。

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優先地位。因此，正如我們現在看到的，我們處於一個更好的位置，訪問率約為 65％，其中大部分是零步驟編輯。這真的非常重要。

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，我們正在繼續改進，並預計 1 月的訪問情況將進一步改善。就 Zeposia 而言，Zeposia 實際上講述了兩次發布的故事。

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，我們看到了良好的成長勢頭。現在 UC 的挑戰更大了。它更受管理，它是更受管理的階級。

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 在幾乎所有的 PBM 中都享有優先地位，但我們也致力於在那裡取得進展。因此我認為很難用籠統的眼光來描述免疫學。Orencia 繼續表現良好，沒有生物相似藥的見解。

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，我們已經準備好推出 KarXT，它的訪問動態與當今免疫學領域的訪問動態非常不同。因此，我們在提供強勁的業績和執行力方面不斷取得進展，我們有信心在短期和長期內繼續發展我們的業務。

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

謝謝，亞當。請我們進入下一個問題。

Amit Hazan, Leerink Partners.

Amit Hazan，Leerink Partners。

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

是的，非常感謝，並祝賀你的表演。

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.

請問我有兩個問題。首先，關於 IRA，包括布里斯託在內的許多公司都表示這不是什麼大問題。所以我只是在幫忙，我希望你能幫助我們了解一點，你是如何看待今天沒有退稅的藥物，比如 Opdivo 等 B 部分藥物，以及當它們與今天大幅退稅的藥物如 Eliquis 進行談判時面臨的價格壓力風險。

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，關於你們的一些成長動力，顯然，你們已經對 Sotyktu 和 Opdualag 發表了很多評論，但有些競爭對手已經展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，例如就 Sotyktu 而言，他們正在進行面對面試驗，證明他們的藥物在交叉試驗中比 Sotyktu 和 Opdualag 顯示出更好十年的療效，並將在十年後推出更好的療效，並將在十年後推出更好的療效，並將在十年後推出更好的療效，並將在十年後推出。那麼，您能否對此進行評論？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。我會讓亞當回答第一個問題，其實也可能回答第二個問題。但首先我要說的是，我們不會猜測那些尚未或不打算談判的產品的影響。亞當可以大致講一下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，我認為討論 Opdivo 是否有資格進行 IRA 談判還為時過早。請記住，如果 Opdivo 入選，市場上可能會出現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，我們在 12 月下旬宣布了我們的 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 之前盡可能轉換業務。我們預計在 LOE 之前將 Opdivo 在美國業務總量的至少 30% 至 40% 轉化為收益，我們認為這對醫生和患者來說都是一個很好的機會，我們期待著推出這一重要的配方。此外，由於市場上存在生物相似藥，我們預計 Opdivo 也不會完全衰退。

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 也將在下一個十年繼續發展。至於它與免疫學或 PSO 領域的競爭有關，我認為，更具體地說，正如您所問，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。我們還計劃進行幾項適應症，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 都將獲得批准並將在那時宣讀。

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.

所以我們必須看看這項研究的結果。口服 IL-23 第 3 階段數據需要有顯著差異才能產生影響，但我們將繼續在 Sotyktu 方面取得進展並執行我們的計劃，並專注於發展這一重要品牌。

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.

我想我要補充一點，因為我認為您也提到了 David、Opdualag。就 Opdualag 而言，我們在黑色素瘤適應症方面再次遙遙領先，該藥物已在第一線獲得批准，預計將獲得輔助性黑色素瘤的數據，還預計將很快提供第 2 階段的數據，然後啟動非小細胞肺癌子集的第 3 階段計劃以繼續進展。我們從比賽中看到的其餘數據太少，無法真正解釋任何內容。

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 Cowen。

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，很抱歉我太挑剔了，但你在電話中兩次提到布里斯托爾將在 9 月 1 日左右公佈 Eliquis 業務概況，但你並沒有提到最低指導。當您被具體問及樓層指導時，您重複了通話早些時候的內容。那麼，樓層指導不再在計畫之中了嗎？其次，Samit 在 EoE 上討論了 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 能與之完全競爭嗎？聽起來你很有信心。聽起來是的。從歷史上看，您說這類話的語氣是非常具有預測性的。所以我只是好奇該如何理解它。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，然後將其交給薩米特 (Samit)。所以，我們知道，人們對樓層指導這個主題很感興趣。正如我之前所說，總的來說，我們已經不再提供長期目標了。這實際上反映了我們回顧公司的歷史所作所為。

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.

儘管如此，我們對該業務的長期成長前景仍然充滿信心。我們將繼續向您提供關於該業務的適當更新信息，並且我們將透明地告知您我們對該業務發展的看法。

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，我們將繼續這一流程。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。你看，我們確實做了與 Dupixent 進行比較的研究。因此開始比較數據非常困難。也要記住吞嚥困難的日子的方式，這對於患者的症狀緩解來說是更重要和最重要的事情。我們測量的方式與 Dupixent 在其研究中採用的方式截然不同。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，我們不會對數據的特殊性進行評論，因為我們寧願在醫學會議上展示它，或就此發表評論。當然，正如亞當之前提到的，我們會深入研究數據，並在與監管機構溝通時將其置於正確的視角。

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

請讓我們進入下一個問題，羅科。

Charles Young, UBS.

瑞銀的查爾斯楊（Charles Young）。

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?

大家早安。瑞銀的 Trung Huynh。我對皮下注射 Opdivo 有一些後續研究。所以今天你又強調了 30% 到 40% 的轉換率。您多快能達到這個 30% 到 40% 的患者水準？如我們所見，Darzalex 等藥物具有相當顯著的轉化率，是什麼阻止了它的進一步發展？

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.

那麼，考慮到 CMS 最近關於 IRA 的 subcu 配方草案，預計這種 subcu 與 IV 相比的排他性將持續多久？我記得您在其中一個問題中提到了未來十年，但是您有年份嗎？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.

所以，正如我所說，我們期待 12 月底的 PDUFA 日期，我們的發布計劃正在繼續進展。所以我們說我們已經轉換了至少 30% 到 40% 的美國 Opdivo IV 業務。好消息是我們有時間，因為 LOE 要到 2028 年才到期。因此，我們預計轉化主要來自處於輔助治療的患者，在繼續使用 Opdivo 治療的情況下與 Yervoy 聯合使用，例如一線 RCC 中的轉移性黑色素瘤適應症以及 Opdivo 單藥治療。

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.

這些指標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.

由於我們擁有廣泛的專利，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 將在 2030 年代初期繼續保持我們領先的 IO 特許經營權。

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

謝謝，亞當。請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。關於第三階段試驗的簡短兩點。想知道 ACTION-1 試驗是否已重新開始招募 RZ101 並確保錒系元素的供應。然後，關於美齊多胺的後續試驗，看起來試驗已經進入第 3 階段的第 2 部分。想知道您是否可以告訴我們從第 1 部分到第 2 部分的劑量是多少？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，從中，感謝你提出的關於錒二至五研究的兩個問題。如您所知，我們在指導他們進行 GAAP 第三階段五次試驗方面取得了最大的進展。淨值是第一個有強大數據支持的跡象。

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的招募，我們仍然期待 2026 年的數據讀數，同時期待某些新的適應症，從已經在進行的小細胞肺癌第一階段試驗開始，這可能會再次推動，招募工作仍在繼續，我們尚未宣布其作用。我們已經前進了。但可以肯定的是，兩項試驗都將進入研究的第二部分。您會繼續聽到有關該藥物進展的消息，我們期待著從 2026 年開始的讀數。

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

謝謝，海倫。請我們進入下一個問題。

Olivia Breyer, Cantor Fitzgerald.

奧莉薇亞·布雷耶、費茲傑拉領唱者。

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?

大家早安，感謝您的提問。我想詢問有關 Sotatercept 的後續情況。看起來你們將今年的其他營收預期修改了約 2 億美元。那麼這基本上完全歸功於 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，如果以 22% 即 22% 的特許權使用費率來推算，這個數字很大。那麼，考慮到強勁的經濟形勢，您如何看待 Sotatercept 未來對您損益的貢獻？另外，您能否評論一下大家對 PRMT5 計劃的熱情程度以及我們將在今年下半年看到第一階段的哪些結果？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的那樣，O&E 的成長主要是由兩件事推動的，即糖尿病特許權使用費好於我們的預期，以及利息支出好於預期。

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.

我之前說過與 WINREVAIR 有關，由於我們仍然擁有其智慧財產權，因此該產品全球銷售額的 22% 都流向我們其他成長收入線。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.

感謝奧莉維亞就 PRMT5 提出的問題。當然，我們在這方面的進展非常順利。第一階段試驗仍在持續。我們將要展示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，我們非常期待展示這些數據，因為我們計劃針對幾個適應症啟動第 2 階段研究，隨著我們越來越接近在選定的患者（當然，是 MTAP 缺失的患者）中啟動這些試驗，我們將更多地討論這些試驗。

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

謝謝。請讓我們進入下一個環節。羅科，

Steve Chesney, Redburn Atlantic.

史蒂夫‧切斯尼 (Steve Chesney)，雷德伯恩大西洋公司 (Redburn Atlantic)。

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?

是的，很棒。謝謝。也許只是放射性藥物的後續研究。關於 RYZ101 和 GEP-NET 的商業機會，我想知道競爭對手對 Lutathera 的 ANDA 和 505(b)(2) 申請會對您對該領域創新者的定價想法產生何種影響？

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.

同樣在 KarXT 上，我們在過去一兩個月中看到了一些競爭對手的數據集，這些數據集顯示在相當早期的時間點出現了復發，並且反應率略低於預期。只是想知道你們是如何看待與 KarXT 相關的，你是否對自己的構造更有信心，或者你在劑量上做了不同的事情？謝謝。

Adam, then Samit

亞當 (Adam)，然後是薩米特 (Samit)

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 以及我們這裡的平台的熱情。我們相信這是一個真正令人興奮的平台，它將在未來十年內實現顯著成長。

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 尤其讓我們興奮的是，我們將在未來十年或更長時間內看到強大的 IND 引擎，以及我們所知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.

現在，我認為 GEP-NET 中 RYZ101 的領先項目是一個相當適度的商業機會。然而，當你看到這項技術時，特別是基於錒的放射性藥物平台，它有可能在一系列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，我們正在研究小細胞肺癌以及潛在的許多其他腫瘤類型。因此，我們期待推出 GEP-NET 適應症，它將成為主導資產，以及在未來五年及以後推出的一系列新的 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，有幾件事需要了解。首先，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。這些患者的病情已經非常嚴重。他們正在服用糖皮質激素、免疫抑制劑和免疫調節劑。這些患者可能還患有潛在的器官功能障礙，如腎衰竭和腎損傷。

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.

那麼，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？我們試圖實現緩解，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，並且我們期待在觀察今天正在治療的患者的表現時提供這些數據。

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

謝謝。我們繼續下一個吧？

James Shin, DB

詹姆斯·辛（DB）

Good morning, guys. Thanks for taking the questions.

大家早安。感謝您回答這些問題。

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?

還有一些正在籌備中。為了在今年稍後搭載 PRMT5 讀數，您能否說明一下數據大小以及預期哪些數據點？您認為這將透過會議設定來披露嗎？然後與 CD19 NEX-T 類似，如何唸出？

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.

然後我想另一個問題，我們之前的問題談到了免疫學中的一些談判動力學。許多 CDM 都進入了生物相似藥領域。在您早期的互動中，這是否改變了談判動態？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，你有點崩潰了，詹姆斯。我認為您問的是披露問題？（多位發言者）

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，我們期待今年透過針對這兩種分子的醫學會議展示相關數據。對於 PRMT5，我們預期所有已招募的患者都能獲得劑量的整體安全性以及我們看到的反應。

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，這就是我們將要展示的數據。對於 KarXT，我們期待在即將舉行的會議上展示有關 SLE 的數據，然後在此基礎上進一步發展。顯然，我們正在準備併計劃與監管機構進行對話，以規劃該分子的後期開發階段。

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。關於生物相似藥的問題，正如我所提到的，在 UC 中，是的，生物相似藥在一線確實佔有優先地位。然而，就 PSO 市場而言，我們將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 轉向優先採用生物相似藥的方法。造成這種情況的主要原因是，在 PSO 中，Humira 和 Stelara 等產品並未佔據主導地位。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環節。

Kripa Devarakonda, Truist Securities.

Devarakonda 先生，Truist Securities 成員。

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。非常感謝您回答我的問題，並祝賀您本季度的表現，其中一個問題是關於加拿大的，也許這是一個問題，我在 10 天裡一直關注患者倡導者，開始看到過去幾個季度有所加速。

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定狀態，這只是噪音，或者這可能是未來的趨勢，正在增加吸收？關於 IRA 的另一件事實際上更具未來感。也許，您是否認為 11 月選舉的結果會對我們的實施產生潛在影響？還會有什麼變化嗎？謝謝。

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

那麼亞當，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。我們看到 Camzyos 穩定、持續地成長。正如 David 所提到的，我們發現使用商業藥物的患者數量與上一季相比增加了約 1,300 人。我們預計，隨著時間的推移，這一增長將保持穩定和持續。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，同時也擴大一些小型機構和一些大型社區實踐的處方廣度。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.

這些都是 Eliquis 代表，他們進入心臟病學社區來推動治療。因此，我們看到 Camzyos 的發展勢頭良好，我們對這款非常重要的產品的表現感到滿意。

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

我知道我們可能還要再超時兩次。因此，請轉到下一個。

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.

嘿，大家好。感謝您接手這個任務－感謝您回答我的問題。或許是給 Samit 的一個。因此，我們將在大約一個月內獲得 ESC 的海洋 AF 數據。顯然，Librexia AF 仍在繼續，時間將證明它是否與我們在 Asundexian 身上看到的快速失敗有任何區別。

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.

但正如所指出的，太平洋的劑量發現可能不足，但是您正在尋找哪些有關這些數據機制的具體資訊？您是否認為所獲得的數據明確表明對 XIa 因子活性的充分抑制存在任何風險，是否會對中風預防產生不利影響？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 Samit 回答之前，我想先快速回答 Kripa 問題的第二部分，關於病人。顯然，我們將繼續關注美國的大選，很難推測任何一屆政府的政策角度將如何變化，因為這不僅僅是一場總統選舉，還必須考慮國會的組成。所以我認為我們必須持續關注這個問題。但是薩米特，你想解決嗎？

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。也感謝您的提問。看起來，我想讓我們從第一個事實開始，當我們啟動 Milvexian 計劃時，它是基於第二階段研究的先前經驗。這就是為什麼我們選擇劑量的原因，對於單一藥物，我們選擇的劑量較高，為 100 毫克 BID，而對於有抗血小板藥物背景的藥物，我們選擇的劑量為 25 毫克 BID。

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 之間的區別，顯示抑製作用以及真正抑制 XIa 因子所需的時間和劑量。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 AF、二級中風預防以及 ACS，這三項試驗的招募工作進展順利，我們期待這些讀數。最後我想說的是，當數據呈現時，我們當然希望看到發生的事件的數量、發生的時間以及所用劑量的影響，這些對於我們考慮 Milvexian 都非常有幫助。

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

偉大的。謝謝。我們來聽最後一個吧，羅科。

Alex Hammond, BofA.

美國銀行的亞歷克斯·哈蒙德（Alex Hammond）。

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.

嘿，大家好。謝謝你擠進我。因此，遵循 Camzyos 本季的強勁表現和 ACC 的 REMS 註冊數據。您能否對未來潛在的 REMS 修改設定一些期望？您是否認為明年初 ODYSSEY 研究結果的發表將為與 FDA 重新接觸提供有利時機？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——感謝您的提問，正如大衛和亞當之前所說，現在已有數千名患者接受了 Camzyos 治療，當然，我們已經學到了很多東西，我們看到了可控的情況以及這些患者所取得的轉變結果，並且這些患者接受了很長時間的治療，其中 80% 的患者接受 2.5 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 進行對話。我不會談論細節。當然，現在我們已經在大約六個月後獲得了非阻塞性肥厚型心肌病變研究的讀數，預計明年第二季度將獲得讀數，我們當然也會在這方面與 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，我可能會想給你們留下幾件事。我們對業務表現感到滿意，尤其是成長組合的表現，上半年收入成長良好，現在正如 David 之前所說，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，我們的產品線不斷向新藥方向發展，我們期待未來幾個月內出現重要的催化劑，如 KarXT 的推出和一系列數據讀數。所以總的來說，我認為我們本季的表現很好。

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.

我們對全年業績感到十分樂觀，並相應提高了我們的預期。今年下半年肯定會很忙碌，我們作為一個團隊和公司將專注於推動強有力的執行。非常感謝大家今天的寶貴時間，投資人關係團隊很樂意解答大家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.

謝謝您，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。現在您可以斷開連接並享受美好的一天。