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Operator
Operator
Good day and welcome to the Bristol-Myers Squibb first-quarter 2025 earnings conference call.
大家好,歡迎參加百時美施貴寶 2025 年第一季財報電話會議。
(Operator Instructions) Please note this event is being recorded.
(操作員指示)請注意,此事件正在被記錄。
I would now like to turn the conference over to Mr. Chuck Triano, Senior Vice President and Head of Investor Relations. Please go ahead, sir.
現在,我想將會議交給資深副總裁兼投資者關係主管查克·特里亞諾先生。先生,請繼續。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thank you and good morning everyone. We appreciate you joining our first-quarter 2025 earnings call.
謝謝大家,早安。感謝您參加我們的 2025 年第一季財報電話會議。
Joining me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Lenkowsky, our Chief Commercialization Officer and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development.
今天上午,與我一起發表準備好的演講的還有我們的董事會主席兼首席執行官克里斯·伯納 (Chris Boerner) 和我們的首席財務官戴維·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藥物開發主管 Samit Hirawat。
Earlier this morning, we posted our quarterly slide presentation to bms.com that you can use to follow along with Chris and David's remarks.
今天早些時候,我們將季度幻燈片演示發佈到了 bms.com,您可以透過它來關注 Chris 和 David 的演講。
Before we get started, I'll remind everybody that during this call, we will make statements about the company's future plans and prospects that 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 representing our estimates as of any future date. And 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.
在我們開始之前,我要提醒大家,在本次電話會議中,我們將對公司的未來計畫和前景做出構成前瞻性陳述的陳述。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今天的估計,不應被視為代表我們對任何未來日期的估計。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。我們還將重點關注非公認會計準則財務指標的評論,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。
Finally, unless otherwise stated, all comparisons are made from the same period in 2024 and sales growth rates will be discussed on an underlying basis which excludes the impact of foreign exchange. All references to our P&L are on a non-GAAP basis.
最後,除非另有說明,所有比較均基於 2024 年同期,且銷售成長率將在排除外匯影響的基礎基礎上進行討論。所有對我們損益表的引用均基於非 GAAP 基礎。
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。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Thanks, Chuck. Good morning and thank you all for joining our first-quarter earnings call.
謝謝,查克。早安,感謝大家參加我們的第一季財報電話會議。
We had a strong Q1, driven by solid execution across the business and continued focus on our strategic priorities, maximizing our growth portfolio, accelerating our R&D pipeline, driving operational excellence, and strategically allocating capital. Our plans to transition the portfolio to deliver long-term sustainable growth are underway.
我們的第一季表現強勁,這得益於整個業務的穩健執行,以及我們繼續專注於策略重點、最大化我們的成長組合、加速我們的研發管道、推動卓越營運以及策略性地配置資本。我們正在進行投資組合轉型計劃,以實現長期可持續成長。
Today, I will begin with some comments on our first-quarter performance and highlight our recent accomplishments. Then, I will discuss our pipeline and upcoming catalyst that can further strengthen our long-term growth potential. I'll end by addressing the current operating climate.
今天,我將首先對我們的第一季業績進行一些評論,並強調我們最近的成就。然後,我將討論我們的產品線和即將到來的催化劑,以進一步增強我們的長期成長潛力。最後,我想談談目前的經營環境。
Starting with performance on slide 4, our growth portfolio again delivered double-digit sales growth driven primarily by strength in key marketed products, including our IO portfolio, BREYANZI, REBLOZYL, and CAMZYOS. And as expected, our legacy portfolio performance primarily reflected the impact of generic entries for certain older brands.
從幻燈片 4 上的表現開始,我們的成長產品組合再次實現了兩位數的銷售成長,這主要得益於主要市場產品的強勁成長,包括我們的 IO 產品組合、BREYANZI、REBLOZYL 和 CAMZYOS。正如預期的那樣,我們原有的產品組合表現主要反映了某些老品牌通用產品的影響。
So turning back to our growth portfolio, let me speak to our recent launches. As you'll recall, in October, we launched COBENFY, the first truly novel mechanism for the treatment of schizophrenia in decades, and we are pleased with the early prescription trends. Patient and physician feedback is very positive, reflecting its favorable tolerability and efficacy profile and noting that patients are observing cognitive benefits.
回到我們的成長投資組合,讓我來談談我們最近推出的產品。您可能還記得,今年 10 月,我們推出了 COBENFY,這是幾十年來首個真正新穎的精神分裂症治療機制,我們對早期的處方趨勢感到滿意。患者和醫生的回饋非常積極,反映了其良好的耐受性和療效,並注意到患者正在觀察到認知益處。
In January, we launched our Opdivo Qvantig, the subcutaneous formulation of nivolumab, which is also receiving promising early feedback from practices and patients. And based on our performance in the first quarter, we are increasing our top- and bottom-line guidance. David will provide more details shortly.
今年 1 月,我們推出了 Opdivo Qvantig,這是 nivolumab 的皮下製劑,它也從實踐和患者那裡獲得了積極的早期回饋。根據第一季的業績,我們提高了營收和淨利預期。David 很快就會提供更多詳細資訊。
We continue to advance our pipeline during the quarter with several recent announcements. Opdivo plus Yervoy received FDA and EMA approvals for the treatment of first-line liver cancer and FDA approval for use in MSI-high colorectal cancer in the US, further solidifying its leadership in immuno-oncology.
我們在本季繼續推進我們的產品線,最近發布了幾份公告。Opdivo 聯合 Yervoy 獲得美國 FDA 和 EMA 批准用於治療一線肝癌,並在美國獲得 FDA 批准用於治療 MSI 高結腸直腸癌,進一步鞏固了其在免疫腫瘤學領域的領先地位。
BREYANZI was approved in the EU for treatment of follicular lymphoma, expanding our cell therapy presence in blood cancers. CAMZYOS received approval in Japan and a favorable label update in the US, which reduces the REMs echo monitoring requirement in the maintenance phase. In addition, Milvexian reached an important milestone in the quarter with the completion of enrollment in the LIBREXIA atrial fibrillation trial. This event-driven study remains on track to read out in 2027.
BREYANZI 在歐盟獲得批准用於治療濾泡性淋巴瘤,擴大了我們在血癌領域的細胞治療應用。CAMZYOS 在日本獲得批准,並在美國獲得了有利的標籤更新,這降低了維護階段的 REM 迴聲監測要求。此外,Milvexian 在本季度完成了 LIBREXIA 心房顫動試驗的招募,達到了一個重要的里程碑。這項事件驅動的研究預計將於 2027 年完成。
Turning to slide 5 and our two recent top line readouts. While we're disappointed that the CAMZYOS ODYSSEY study in non-obstructive HCM and the COBENFY ARISE study in adjunctive schizophrenia did not meet their primary endpoints, I want to put the results in proper context. Although these are not the results that we had hoped for, neither outcome meaningfully alters our strategy or growth trajectory.
翻到投影片 5 和我們最近的兩條頂線讀數。雖然我們對非阻塞性 HCM 中的 CAMZYOS ODYSSEY 研究和輔助性精神分裂症中的 COBENFY ARISE 研究未達到其主要終點感到失望,但我希望將結果放在適當的背景下。儘管這些都不是我們所希望的結果,但這兩種結果都不會顯著改變我們的策略或成長軌跡。
For CAMZYOS, the studies strongly suggests that non-obstructive and obstructive HCM behave distinctly. We do not expect these data to significantly impact peak sales, and our focus remains on our existing obstructive HCM indication, which represents the vast majority of the market opportunity.
對於 CAMZYOS,研究強烈表明非阻塞性和阻塞性 HCM 表現截然不同。我們預計這些數據不會對高峰銷售產生重大影響,我們的重點仍然放在現有的阻塞性 HCM 適應症上,這代表了絕大多數的市場機會。
For COBENFY, although it did not demonstrate a statistically significant improvement as an adjunctive treatment in the ARISE trial, these data are encouraging, showing a noteworthy improvement for the majority of patients as well as a tolerable safety profile. As we noted earlier this week, we will complete a full evaluation of the Phase 3 trial data and we'll plan to engage with the medical community and regulators to discuss these results and potential next steps.
對於 COBENFY 而言,儘管在 ARISE 試驗中作為輔助治療並未表現出統計學上顯著的改善,但這些數據令人鼓舞,表明大多數患者都有顯著改善,並且具有可容忍的安全性。正如我們本週早些時候指出的那樣,我們將完成對第三階段試驗數據的全面評估,並計劃與醫學界和監管機構合作討論這些結果和可能的後續步驟。
Also, it's important to remember, there are no currently approved adjunctive therapies for schizophrenia. Our commercial strategy remains focused on monotherapy, which accounts for 70% to 80% of the market, where our goal is for COBENFY to become the foundational treatment. As I mentioned earlier, COBENFY's differentiated profile is resonating, and we're seeing strong early uptake.
此外,需要記住的是,目前尚無核准的精神分裂症輔助療法。我們的商業策略仍然專注於單一療法,該療法佔據了 70% 至 80% 的市場份額,我們的目標是讓 COBENFY 成為基礎治療方法。正如我之前提到的,COBENFY 的差異化形象引起了共鳴,我們看到了強勁的早期吸收。
Looking ahead, we're confident in the strength of our portfolio and the breadth of opportunities in our pipeline. We expect several of these opportunities to come this year, such as the first look at one of the Phase 3 trials for COBENFY and Alzheimer's disease psychosis where there is significant unmet need.
展望未來,我們對我們的產品組合實力和我們擁有的廣泛機會充滿信心。我們預計今年將會出現幾個這樣的機會,例如首次考察 COBENFY 和阿茲海默症精神病的 3 期試驗之一,該試驗存在大量未滿足的需求。
We also plan to initiate several new pivotal studies this year, including seven Phase 3 studies for COBENFY across three indications; Alzheimer's agitation, Alzheimer's cognition impairment, and bipolar I, all expected to be underway by mid-year.
我們也計劃今年啟動幾項新的關鍵研究,包括針對三種適應症的七項 COBENFY 3 期研究;阿茲海默症躁動症、阿茲海默症認知障礙和雙相情感障礙 I 型預計將於年中開始治療。
At the same time, in oncology, we're advancing two next wave solid tumor programs. First, our EGFR HER3 antibody drug conjugate, iza-bren, is expected to begin enrollment in a pivotal study in first-line triple negative breast cancer in the coming months. And second, our androgen receptor degrader program in prostate cancer has begun enrolling patients in a pivotal study. We also expanded our registrational program for golcadomide, a potential first-in-class CELMoD for lymphoma.
同時,在腫瘤學領域,我們正在推動兩項下一波實體瘤計畫。首先,我們的 EGFR HER3 抗體藥物偶聯物 iza-bren 預計將在未來幾個月內開始參與一線三陰性乳癌的關鍵研究。其次,我們的前列腺癌雄性素受體降解劑計畫已開始招募患者參與一項關鍵研究。我們還擴大了戈卡多胺的註冊計劃,這是一種潛在的用於治療淋巴瘤的首創 CELMoD 藥物。
The [Goal Seek four] study in second line plus follicular lymphoma will explore the combination of golcadomide with rituximab where we know effective chemo-free regimens are needed for patients. In total, we believe these programs represent significant opportunities over the back half of the decade given the unmet medical need.
二線及以上濾泡性淋巴瘤的 [Goal Seek four] 研究將探討戈卡多胺與利妥昔單抗的聯合治療,我們知道患者需要有效的無化療方案。總體而言,我們認為,考慮到未滿足的醫療需求,這些項目在未來五年將帶來重大機會。
The numerous pivotal data readouts in the coming years have the potential to meaningfully enhance the long-term strength of our growth portfolio. Our commitment to innovating for patients remains strong as we advance first and our best-in-class medicines, both through internal discovery and business development, which remains a top priority. In terms of BD, we're actively pursuing opportunities that can enhance our growth profile where there's strong strategic alignment and financial rationale. With our renewed organizational agility and balance sheet in a solid position, we have the flexibility to act decisively when we find the right opportunities.
未來幾年的眾多關鍵數據有可能顯著增強我們成長投資組合的長期實力。我們始終致力於為患者進行創新,透過內部發現和業務開發來推進首創和一流的藥物,這仍然是我們的首要任務。在 BD 方面,我們正在積極尋求能夠增強我們成長前景的機會,這些機會具有強大的策略一致性和財務理由。憑藉我們重新煥發的組織敏捷性和穩固的資產負債表,我們可以靈活地在發現合適的機會時果斷採取行動。
As we've said, maximizing long-term growth starts with strong execution this year and over the midterm. The growth portfolio is performing well and our pipeline is advancing. At the same time, we're taking deliberate actions to right size our cost structure and become a more efficient company. Overall, I'm confident we will deliver on disciplined execution as we position the company for top-tier growth by the end of the decade.
正如我們所說,實現長期成長最大化始於今年和中期的強勁執行。成長投資組合表現良好,我們的產品線正在不斷推進。同時,我們正在採取謹慎的措施來調整我們的成本結構,並成為一家更有效率的公司。總體而言,我相信我們將嚴格執行,使公司在本世紀末實現頂級成長。
Before I turn it over to David, I'll just say a few words on the current global operating climate. There's a lot of uncertainty whether related to tariffs, a potential economic downturn, or restructuring at the FDA and HHS. This backdrop notwithstanding, our focus continues to be on building a strong and resilient company that can navigate and manage through operating complexities. We remain confident in our ability to deliver for our patients, employees, and shareholders.
在將發言權交給戴維之前,我先簡單談談目前的全球經營環境。無論是與關稅、潛在的經濟衰退或 FDA 和 HHS 的重組有關,都存在著許多不確定性。儘管有這樣的背景,我們的重點仍然是建立一家強大而有韌性的公司,能夠應對和管理複雜的營運問題。我們對自己為病人、員工和股東提供服務的能力充滿信心。
Our strategy is clear and we're executing. We have a rich pipeline with strong growth potential. We act swiftly when we see opportunities, whether it's business development to bring in great science or pursuing efficiencies in our business. And finally, we are laser focused on execution as you can see by our strong performance this quarter.
我們的策略很明確,我們正在執行。我們擁有豐富的產品線和強勁的成長潛力。當我們看到機會時,我們會迅速採取行動,無論是透過業務發展引入偉大的科學還是追求業務效率。最後,我們非常注重執行,正如您從本季度的強勁表現所看到的那樣。
With that, I'll turn it over to David.
說完這些,我就把麥克風交給大衛。
David Elkins - Executive Vice President, Chief Financial Officer
David Elkins - Executive Vice President, Chief Financial Officer
Thank you, Chris, and good morning, everyone.
謝謝你,克里斯,大家早安。
Our performance in 2025 is off to a strong start. We're executing our growth strategy in terms of driving revenue for key products while also rightsizing our cost structure. Our persistent focus on execution is strengthening our foundation and positioning the company to deliver long-term sustainable growth.
我們的 2025 年業績開局良好。我們正在實施成長策略,推動主要產品的收入成長,同時調整成本結構。我們堅持不懈地專注於執行,以加強我們的基礎並使公司實現長期可持續成長。
This morning, I'll provide highlights of our performance in the first quarter and then review our outlook for the year. Now turning to the first quarter on slide 7, total company revenues were approximately $11.2 billion, reflecting strong demand across our growth portfolio, including the launch of COBENFY offset by the impact of generics and Medicare Part D redesign, primarily in our legacy portfolio. Global sales of the growth portfolio increased approximately 18%, led by key brands including our IO portfolio; BREYANZI, REBLOZYL, and CAMZYOS.
今天上午,我將介紹我們第一季的業績亮點,然後回顧我們對今年的展望。現在轉到幻燈片 7 上的第一季度,該公司總收入約為 112 億美元,反映了我們成長產品組合的強勁需求,包括 COBENFY 的推出,但仿製藥和 Medicare Part D 重新設計的影響抵消了這一影響,主要是在我們的傳統產品組合中。成長產品組合的全球銷售額成長了約 18%,其中以 IO 產品組合等主要品牌為主導;布雷揚齊、雷布洛齊爾和卡姆齊奧斯。
Turning to key product performance on slide 8. Opdivo had a solid first quarter with global revenue up 12%, driven primarily by volume growth. Separately, initial sales of Opdivo Qvantig were approximately $9 million in the quarter. The US launch is progressing well with early adoption across multiple tumor types. We continue to believe that physicians will convert approximately 30% to 40% of patients to this new product.
前往第 8 張投影片上的關鍵產品效能。Opdivo 第一季表現穩健,全球營收成長 12%,主要得益於銷售成長。另外,Opdivo Qvantig 本季的初始銷售額約為 900 萬美元。美國的上市工作進展順利,已在多種腫瘤類型中早期採用。我們仍然相信醫生將使大約 30% 到 40% 的患者轉用這種新產品。
Let's turn to hematology on slide 9. REBLOZYL global sales reflect the continued strength across first- and second-line MDS-associated anemia. Higher sales in the US were related to increased use in first-line setting. Outside of the US, REBLOZYL's strong double-digit sales growth was driven by demand across newly launched markets in Europe and Japan.
讓我們翻到第 9 張投影片上的血液學。REBLOZYL 的全球銷售反映了一線和二線 MDS 相關貧血治療的持續強勁表現。美國銷售額的成長與第一線治療的使用增加有關。在美國以外,REBLOZYL 強勁的兩位數銷售成長得益於歐洲和日本等新興市場的需求。
In cell therapy, BREYANZI was another key contributor to our strong growth portfolio performance in the quarter, driven by demand across all indications. US sales more than doubled and international sales tripled.
在細胞療法領域,BREYANZI 是我們本季強勁成長投資組合表現的另一個關鍵貢獻者,這得益於所有適應症的需求。美國銷售額成長了一倍多,國際銷售額成長了兩倍。
Moving to cardiovascular on slide 10, let's start with CAMZYOS. Sales in the first quarter nearly doubled, benefiting from strong global demand. Brand momentum in the quarter was driven by new patient starts and a 19% increase in total prescriptions for the three months ended March 31. We continue to expect steady growth of CAMZYOS in 2025 due to its compelling efficacy and safety profile in obstructive HCM.
轉到幻燈片 10 上的心血管,讓我們從 CAMZYOS 開始。受惠於全球強勁需求,第一季銷售額幾乎翻了一番。本季品牌發展動能主要得益於新患者的加入以及截至 3 月 31 日的三個月內處方總量增加 19%。由於 CAMZYOS 在阻塞性 HCM 方面具有顯著的療效和安全性,我們預期 CAMZYOS 在 2025 年將持續穩定成長。
Turning to Eliquis. Global sales were down 3% in a quarter, mainly due to the impact of Medicare Part D redesign in the US. We continue to expect total Eliquis revenue to be stronger in the second half of the year, primarily due to Part D redesign and elimination of the coverage gap.
轉向 Eliquis。全球銷售額本季下降了 3%,主要原因是美國醫療保險 D 部分重新設計的影響。我們繼續預計 Eliquis 的總收入在下半年將會更加強勁,這主要歸功於 D 部分的重新設計和覆蓋範圍差距的消除。
Moving to immunology on slide 11, across our immunology portfolio, we saw higher commercial rebates, as previously discussed, related to improved access and Medicare Part D redesign. First quarter Sotyktu sales reflect the demand growth and gross to net impacts related to higher commercial rebates. We will continue to leverage our broader axis position to drive further demand growth.
轉到幻燈片 11 上的免疫學,在我們的免疫學產品組合中,我們看到了更高的商業回扣,如前所述,這與改善獲取途徑和 Medicare D 部分的重新設計有關。第一季 Sotyktu 的銷售額反映了需求成長以及與更高的商業回扣相關的總淨額影響。我們將繼續利用我們更廣泛的軸心地位來推動進一步的需求成長。
Now moving to slide 12, in its first full quarter on the market, COBENFY is off to a solid start with sales of approximately $27 million, driven primarily by demand. During the quarter, weekly total prescriptions remained strong, tracking ahead of all branded schizophrenia launched benchmarks.
現在轉到第 12 張投影片,在上市的第一個完整季度中,COBENFY 取得了良好的開局,銷售額約為 2700 萬美元,主要受需求推動。本季度,每週總處方量保持強勁,領先所有品牌精神分裂症藥物的上市基準。
Now let's move to the P&L on slide 13. Gross margin was approximately 73%, primarily due to product mix. Operating expenses were more than $500 million lower compared to the same period last year, primarily reflecting the results of our strategic productivity initiative. Our effective tax rate in the quarter was 15.1%, primarily driven by earnings mix, and overall diluted earnings per share were $1.80.
現在讓我們轉到第 13 張投影片上的損益表。毛利率約73%,主要由於產品組合。與去年同期相比,營運費用減少了 5 億多美元,這主要反映了我們策略生產力措施的成果。本季我們的有效稅率為 15.1%,主要由收益組合推動,每股整體稀釋收益為 1.80 美元。
Turning to the balance sheet and capital allocation highlights on slide 14, our financial position remains strong, with approximately $12.1 billion in cash equivalents and marketable securities as of March 31. We generated cash flow from operations of approximately $2 billion in the first quarter. In terms of capital allocation, we maintain our strategic and balanced approach. As Chris highlighted earlier, business development remains a top priority, and we continue to actively assess opportunities in line with our strategy, and we remain on track with our plan to pay down $10 billion of debt relative to our March 31, 2024, balance. Our capital allocations also include rewarding shareholders through the dividend. 2025 marks our 93rd consecutive year of dividend payments.
轉向投影片 14 上的資產負債表和資本配置重點,我們的財務狀況依然強勁,截至 3 月 31 日,現金等價物和有價證券約為 121 億美元。我們第一季的經營現金流約為 20 億美元。在資本配置方面,我們保持策略性和平衡性的方法。正如克里斯之前強調的那樣,業務發展仍然是重中之重,我們將繼續根據我們的策略積極評估機會,並且我們將繼續按照計劃償還相對於 2024 年 3 月 31 日餘額的 100 億美元債務。我們的資本配置還包括透過股利獎勵股東。 2025 年是我們連續第 93 年派發股利。
In addition to strategically allocating capital, we are also driving operational excellence through our previously announced strategic productivity initiative. With respect to our 2025 expansion, we expect to realize approximately $2 billion in annual cost savings by the end of 2027, and we remain on track to deliver $1 billion of these savings by the end of this year.
除了策略性地分配資本之外,我們還透過先前宣布的策略生產力計劃推動卓越營運。對於我們 2025 年的擴張,我們預計到 2027 年底將實現每年約 20 億美元的成本節約,並且我們預計在今年年底前實現 10 億美元的成本節約。
Now turning to our outlook, starting with revenue on slide 15. We are increasing our full-year revenue guidance to a range of approximately $45.8 billion to $46.8 billion, reflecting strong performance of our growth portfolio, better-than-expected legacy sales in the first quarter, and a favorable impact of approximately $500 million related to foreign exchange rates relative to our previous 2025 guidance.
現在轉向我們的展望,從第 15 張投影片上的收入開始。我們將全年營收預期上調至約 458 億美元至 468 億美元,這反映了我們成長投資組合的強勁表現、第一季優於預期的傳統銷售,以及相對於我們先前的 2025 年預期,與外匯匯率相關的約 5 億美元的有利影響。
Additionally, we now expect legacy portfolio to decline approximately 16% to 18% for the year, a more moderate rate than previously anticipated, due primarily to REVLIMID's strong Q1 performance. We now project full-year sales of REVLIMID to be at the top end of our previously guided range of $2 billion to $2.5 billion. We maintain our gross margin guidance at approximately 72%. We continue to expect underlying operating expenses to be approximately $16 billion with an additional impact of about $200 million due to foreign exchange rates.
此外,我們現在預計,今年遺留投資組合的跌幅將達到約 16% 至 18%,這一降幅比之前預期的要溫和,這主要歸因於 REVLIMID 第一季的強勁表現。我們現在預計 REVLIMID 全年銷售額將達到我們先前預測的 20 億美元至 25 億美元的最高水準。我們將毛利率預期維持在約 72%。我們繼續預計基本營運費用約為 160 億美元,此外由於外匯匯率的影響,還將產生約 2 億美元的額外影響。
Expenses are now anticipated to be higher in the second half of the year compared to the first half, reflecting timing of investments. Our operating margin target of approximately 37% for the full year remains unchanged.
目前預計下半年的支出將高於上半年,這反映了投資時機的變化。我們全年約 37% 的營業利潤率目標保持不變。
For OI&E, we now expect annual income of approximately $100 million due to higher-than-anticipated royalties and favorable interest income. Although the first quarter tax rate was slightly lower than our full year projection, we're maintaining our full-year tax rate guidance of 18%. As a result of these changes, we are raising the midpoint of our 2025 non-GAAP EPS guidance by $0.15 per share, with an expected range between $6.70 and $7. Our revised guidance includes the estimated impact of current tariffs on US products shipped to China but does not account for any potential pharmaceutical sector tariffs.
對於 OI&E,由於特許權使用費高於預期且利息收入良好,我們現在預計年收入約為 1 億美元。儘管第一季的稅率略低於我們的全年預測,但我們仍維持 18% 的全年稅率指引。由於這些變化,我們將 2025 年非 GAAP EPS 預測中點上調 0.15 美元/股,預期範圍在 6.70 美元至 7 美元之間。我們的修訂指南包括當前關稅對運往中國的美國產品的估計影響,但沒有考慮任何潛在的製藥業關稅。
In summary, our strong performance in the first quarter reflects our focus on disciplined execution. We are well positioned to manage the near-term uncertainty in the macro environment while advancing our long-term growth strategy.
總而言之,我們第一季的強勁表現反映了我們對嚴格執行的重視。我們已做好準備,在推動長期成長策略的同時,應對宏觀環境中的短期不確定性。
And with that, I'll now turn the call over to Chuck for Q&A.
現在,我將把電話交給查克進行問答。
Operator
Operator
(Operator Instructions)
(操作員指示)
Christopher Schott, JP Morgan.
摩根大通的克里斯多福·肖特。
Christopher Schott - Analyst
Christopher Schott - Analyst
Maybe just two ones for me. Just first bigger picture, I think about tariffs and the 232 stuff that's going on right now, can you just provide any color on the company's US manufacturing footprint ability to shift manufacturing to the US over time just in general your ability to navigate this dynamic. I know the details are lacking right now, but just maybe just help frame out how you're thinking about this.
對我來說也許只有兩個。首先從更大的角度來看,我想到關稅和目前正在發生的 232 事件,您能否提供有關公司在美國的製造足跡以及隨著時間的推移將製造轉移到美國的能力,以及您總體上應對這種動態的能力。我知道現在還缺乏細節,但也許只是有助於闡明你對此的看法。
And then the second question for me was on COBENFY just in light of the adjunctive results we saw. Just talk a little bit about what this does for your outlook on COBENFY, and just how you think about kind of use in adjunctive given the negative trial results we saw. Thanks so much.
然後,對我來說,第二個問題是關於 COBENFY 的,僅基於我們看到的輔助結果。請稍微談談這對您對 COBENFY 的看法有何影響,以及考慮到我們看到的負面試驗結果,您如何看待其輔助用途。非常感謝。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
So thanks for the questions, Chris. I will start with your tariff question and I'll turn it over to Adam to address COBENFY.
謝謝你的提問,克里斯。我將從您的關稅問題開始,然後將其交給 Adam 來回答 COBENFY 的問題。
So first, let me just say at the outset that we certainly appreciate the administration's efforts to enhance US manufacturing as we think about the pharma sector though, obviously that needs to be done in a very thoughtful and deliberate way. And as you can appreciate, there's a lot that we don't know here. We don't have specifics on the outcome of this investigation, but our hope is that wherever this lands, we ultimately end up enhancing the competitiveness of US companies like BMS.
首先,我首先要說的是,我們當然讚賞政府為加強美國製造業所做的努力,但就製藥業而言,這顯然需要以非常周到和謹慎的方式來進行。正如你所了解的,這裡還有很多我們不知道的事情。我們目前還沒有關於此次調查結果的具體信息,但我們希望,無論調查結果如何,最終都能增強 BMS 等美國公司的競爭力。
We are a significantly US-based company today. We have been up investing in core infrastructure in the US for many years, so we need to ensure that ultimately our trade policies enhance the sector and support efforts like the ones we've been making in terms of our exposure again what we've said is the tariffs that have gone into place, namely around China, have been reflected in the guidance that we've provided today. It really is simply too early to provide a lot more on pharma-specific sectors, so we'll have to wait for the specifics there, and once we have them, obviously we'll continue to update you.
如今,我們是一家總部位於美國的公司。多年來,我們一直在美國的核心基礎設施上進行投資,因此我們需要確保我們的貿易政策最終能夠增強該行業,並支持我們在曝光方面所做的努力,我們所說的已經實施的關稅,特別是在中國,已經反映在我們今天提供的指導中。現在提供更多關於製藥特定領域的信息還為時過早,所以我們必須等待具體細節,一旦我們掌握了這些信息,我們顯然會繼續向你們更新。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Adam, do you want to talk about COBENFY?
亞當,你想談談 COBENFY 嗎?
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Sure. As Chris stated in his opening remarks, we don't expect these data to have a meaningful impact on COBENFY sales, Chris. Recall about 70% to 80% of patients are treated with monotherapy, and clearly that's the most significant commercial opportunity and it's also the treatment goal for psychiatrists.
當然。正如克里斯在開場白中所說,我們不希望這些數據對 COBENFY 的銷售產生重大影響,克里斯。回想一下,大約 70% 到 80% 的患者接受單一療法治療,顯然這是最重要的商業機會,也是精神科醫師的治療目標。
What happens in the real world, psychiatrists exhaust monotherapy options before trying adjunctive use, and that's after several failed monotherapy treatments happening later in line, third line, fourth line, plus. Our focus is moving COBENFY earlier in treatment. That's exactly what we've been seeing in the market. In fact, roughly 40% to 50% of the COBENFY prescribing today is now in second line and third line.
在現實世界中,精神科醫生在嘗試輔助治療之前會用盡所有單一療法,而且這是在後續的三線、四線等多種單一療法治療失敗之後。我們的重點是將 COBENFY 應用於早期治療。這正是我們在市場上看到的。事實上,目前 COBENFY 處方中大約有 40% 到 50% 屬於二線和三線藥物。
And so physicians have also told us both in research and through advisory boards that missing the endpoint of the study would have no impact on monotherapy usage or their willingness to use COBENFY, particularly when you look at the safety of the study results.
因此,醫生也在研究中和透過諮詢委員會告訴我們,錯過研究終點不會對單一療法的使用或他們使用 COBENFY 的意願產生影響,特別是當你考慮研究結果的安全性時。
There's a significant unmet need that still exists for patients with schizophrenia, and COBENFY fills the need with its efficacy and safety profile, and that's why we're seeing strong uptake in the market since launch with positive feedback from both physicians and for patients. So we're going to continue to execute our plan for COBENFY to come to foundational monotherapy treatment, and we have a clear opportunity to continue to drive significant growth.
精神分裂症患者仍然存在著巨大的未滿足需求,而 COBENFY 憑藉其功效和安全性滿足了這一需求,這就是為什麼自推出以來我們看到市場強勁增長,並獲得了醫生和患者的積極反饋。因此,我們將繼續執行 COBENFY 的計劃,以實現基礎單一療法治療,並且我們有明確的機會繼續推動顯著成長。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Thanks, Adam operator.
謝謝,接線生亞當。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Can we take our next question, please?
我們可以回答下一個問題嗎?
Operator
Operator
Mohit Bansal, Wells Fargo.
富國銀行的 Mohit Bansal。
Mohit Bansal - Analyst
Mohit Bansal - Analyst
So Chris, a big picture question for you. I mean, given that -- I mean, there has been a lot of cost rationalization over a period of last couple of years. How are you thinking about R&D here? I mean, again there have been a couple of setbacks here with melanoma and all, but as going forward, I mean when you think about taking bets, I mean is there a change in the thought process and how are you thinking about the future pipeline and [riskiness socket].
所以克里斯,我想問你一個大問題。我的意思是,鑑於這一點——我的意思是,在過去幾年裡,成本已經大量合理化。您如何看待這裡的研發?我的意思是,黑色素瘤和其他方面再次遭遇了一些挫折,但隨著未來的發展,當你考慮接受賭注時,你的思考過程是否會發生變化,你如何看待未來的管道和[風險插座]。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Well, let me say a few things and then obviously just given the focus on R&D, Samit, you can certainly weigh in here.
好吧,讓我說幾件事,然後顯然只是考慮到對研發的關注,薩米特,你當然可以在這裡發表意見。
As you noted, we've been spending a lot of time over the last 18 months focused on a few key things. First, making sure we're driving strong execution, that strong execution in commercial, but really across the enterprise. And I think you see -- you've seen the fruits of those efforts in terms of our performance last year and continuing in the Q1 performance.
正如您所說,過去 18 個月我們花了很多時間專注於一些關鍵的事情。首先,確保我們推動強而有力的執行,即在商業領域、而是在整個企業範圍內的強而有力的執行。我想您已經看到了——從我們去年的業績以及第一季的業績來看,這些努力已經取得了成果。
Second, as you know we've spent a lot of time focusing on making the organization more efficient and more agile that was reflected in the cost optimization efforts we had last year as well as in the $2-billion initiative that we announced in our Q4 call.
其次,正如您所知,我們花費了大量時間致力於提高組織的效率和靈活性,這體現在我們去年的成本優化工作以及我們在第四季度電話會議上宣布的 20 億美元計劃中。
And then third, driving additional productivity coming out of R&D and importantly, delivering on the swath of new opportunities we have coming out of our mid-to-late stage pipeline, and that's going to continue to be a focus. And as I step back and look at the opportunities for the company, the confidence that I have that we can deliver on the growth ambitions for the company in part driven by our internal R&D pipeline remains absolutely unchanged.
第三,推動研發部門的額外生產力,更重要的是,抓住中後期研發過程中出現的大量新機遇,這將繼續成為我們的重點。當我回顧並審視公司面臨的機會時,我堅信我們能夠實現公司的成長目標,而這部分得益於我們內部的研發管道,這信心絲毫沒有改變。
It's important to keep in mind that while the two studies that read out over the last couple of weeks were certainly not the results that we had hoped for, as we said in our prepared remarks, they have no financial or modest financial impact on the company and no impact on the prospects for growth coming out of the decade. And so we're going to continue to stay focused on delivering against that pipeline. We're going to continue to invest in strong areas of science where we have the opportunity to add significant value and we can deliver on our mission for patients and for shareholders.
重要的是要記住,雖然過去幾週宣讀的兩項研究肯定不是我們所希望的結果,但正如我們在準備好的評論中所說的那樣,它們對公司沒有財務影響或只有適度的財務影響,也不會對未來十年的成長前景產生影響。因此,我們將繼續專注於實現這一目標。我們將繼續投資於我們有機會創造巨大價值的科學強項領域,並能夠為患者和股東履行我們的使命。
And also keep in mind that we are in a very strong financial position, that financial position gives us a lot of strategic flexibility to continue to source innovation externally, which we'll also be very much focused on from a capital allocation standpoint.
還要記住,我們的財務狀況非常強勁,這種財務狀況為我們提供了很大的戰略靈活性,可以繼續從外部尋找創新,從資本配置的角度來看,我們也將非常關注這一點。
Samit, you want to (multiple speakers)--
薩米特,你想(多位發言者)——
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Yeah, just to add a couple of things, Chris. Thanks, Mohit, for the question.
是的,克里斯,我再補充幾點。謝謝 Mohit 提出這個問題。
If we just were to put this into context, what has happened over the last five years since I've been here at least. We've had 43 major approvals since that time, so that speaks very loudly of the productivity of this organization, and this is in the top quartile, 98 percentile actually if you look across the industry from a KMR data perspective.
如果我們把這件事放在背景中來看,至少自從我來到這裡五年來發生了什麼事。自那時以來,我們已經獲得了 43 項重大批准,這充分說明了該組織的生產力,如果從 KMR 數據的角度來看整個行業,這是處於前四分位數,實際上是 98 個百分位數。
Certainly, the three setbacks that you talked about are very notable that we've taken into account from an R&D perspective. We learned from these but what it does is now we have to look forward as the vision has already been created, looking forward to 10-plus new molecular entities that we want to bring forward by the end of the decade and 30-plus new indications that we have planned for by the end of the decade, and they will start reading out now and we just started early, yes. But a small opportunity would be in myelofibrosis that will read out later this year. There is of course adapt, which is very eagerly awaited by everyone just like us. And then in 2026, there's a slew of readouts for new molecular entities. So we are well planned for that one and looking forward to just growing the portfolio from there on.
當然,您提到的三個挫折非常值得注意,我們已經從研發的角度考慮到了這些挫折。我們從中學到了東西,但現在我們必須向前看,因為願景已經形成,我們期待著到本世紀末推出 10 多個新的分子實體,併計劃到本世紀末推出 30 多個新的適應症,他們現在就會開始讀出來,我們才剛剛開始,是的。但骨髓纖維化方面可能會出現一個小機會,今年稍後就會揭曉結果。當然還有adapt,這也是我們大家非常期待的。然後在 2026 年,會出現大量有關新分子實體的讀數。因此,我們對此做好了充分的計劃,並期待從那時起擴大投資組合。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
All right, thanks. Let's move to our next question, please.
好的,謝謝。請讓我們進入下一個問題。
Operator
Operator
Luisa Hector, Berenberg.
路易莎·赫克托(Luisa Hector),貝倫貝格(Berenberg)。
Luisa Hector - Analyst
Luisa Hector - Analyst
Maybe, just another question on COBENFY. I'm just wondering how the readout from ARISE impacts your levels of confidence in Alzheimer's psychosis readout, and perhaps any additional trials that you may be planning.
也許,這只是 COBENFY 的另一個問題。我只是想知道 ARISE 的讀數如何影響您對阿茲海默症精神病讀數的信心水平,以及您可能正在計劃的任何其他試驗。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks, Luisa. I'll ask Samit to take that.
謝謝,路易莎。我會讓薩米特 (Samit) 來拿走它。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Yeah, thanks, Luisa for the question.
是的,謝謝 Luisa 提出這個問題。
ARISE data has no impact as we think about Alzheimer's disease psychosis. There are a few reasons for that. One, obviously the disease is very different. Two, Alzheimer's disease overall plan in psychosis as well as future looking cognition impairment and agitation, those are based on the data that have already been generated many years ago, a couple decades ago for xanomeline where it showed statistically significant benefits in the behavioral patterns in patients with Alzheimer's disease.
當我們考慮阿茲海默症精神病時,ARISE 數據沒有影響。造成這種情況的原因有幾個。首先,顯然這種疾病非常不同。二、阿茲海默症在精神病方面的整體計畫以及未來認知障礙和激動,這些都是基於多年前已經產生的數據,幾十年前,對於 xanomeline 來說,它在阿茲海默症患者的行為模式中顯示出了統計學上顯著的益處。
Also from a design perspective, in Alzheimer's disease psychosis, there's a longer duration of treatment of up to 12 weeks, which is obviously going to be beneficial as we think about observation of output for primary and secondary endpoints. So overall confident in the conduct of our studies and as you know, we're also initiating several studies as Chris spoke about earlier, seven different Phase 3 trials this year. So really looking forward to initiation of that program.
另外從設計角度來看,對於阿茲海默症精神病,治療時間長達 12 週,這顯然對我們觀察主要和次要終點的輸出有益。因此,我們總體上對進行研究充滿信心,而且如您所知,正如克里斯之前提到的,我們還啟動了幾項研究,今年將進行七項不同的 3 期試驗。所以真的很期待該計劃的啟動。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Great, thank you. Let's move to our next question.
太好了,謝謝。讓我們進入下一個問題。
Operator
Operator
Geoffrey Meacham, Citi.
花旗銀行的傑弗瑞‧米查姆。
Geoffrey Meacham - Analyst
Geoffrey Meacham - Analyst
Chris, just got a couple for you, another one on tariffs. Maybe if you could just talk about it at a high level in the flexibility of transfer price assumptions either maybe from an IP or tax or site of manufacturing. I wasn't sure also about your ability to step up inventory as a potential strategy as well.
克里斯,我剛剛給你帶來了一些問題,另外一個是關於關稅的。也許您可以從智慧財產權、稅收或製造地點的角度,從高層次談論轉移價格假設的靈活性。我也不確定您是否有能力將增加庫存作為潛在策略。
And then second on BD, just given recent deals for Chinese assets, but also how low valuations are across US SMid biotech, how do these factor in your strategy, or your urgency, et cetera.
其次是關於 BD,考慮到最近對中國資產的交易,以及美國 SMid 生物技術的估值有多低,這些因素如何影響您的策略或緊迫性等等。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Thanks for the questions, Geoff. I hope you're doing well. I will start and then I will ask David to chime in a bit on the transfer pricing component of your tariff question.
謝謝你的提問,傑夫。我希望你一切都好。首先,我將請大衛就關稅問題中的轉讓定價部分發表一些看法。
Obviously, as I said earlier, we've got a lot that we still have to wait and see that comes down with respect to the impact of any pharma industry sector tariffs. We appreciate the fact that the administration is taking time to study this issue. You know well, Geoff, that in this industry our manufacturing networks are incredibly complex. They're global supply chains. You have inputs coming from all over the world. There are long lead times in terms of making changes to the supply chain, manufacturing processes are highly complex, and certainly with respect to BMS, the medicines that we make are critical for patients and can't be easily substituted.
顯然,正如我之前所說,我們還有很多事情需要等待,看看製藥業關稅的影響會如何。我們很欣賞政府花時間研究這個問題。傑夫,你很清楚,在這個行業中,我們的製造網絡極其複雜。它們是全球供應鏈。您收到來自世界各地的意見。供應鏈變更的準備時間很長,製造流程非常複雜,當然就 BMS 而言,我們生產的藥物對病人至關重要,不能輕易取代。
Having said that, in anticipation of potential tariffs, we continue to execute mitigation efforts. We have a broad global manufacturing network where we're looking for opportunities to optimize with tariffs in mind. As I mentioned, we already have a significant presence in the US, and we're continuing to invest and we have already undertaken efforts to reduce risks of disruption and shortages as a result of efforts like onshoring, and we're going to continue those efforts. We're also going to continue to engage with the administration to ensure that ultimately whatever comes down is well thought through and deliberate in terms of how we move forward.
話雖如此,由於預期可能出現的關稅,我們仍將繼續採取緩解措施。我們擁有廣泛的全球製造網絡,我們正在尋找優化關稅的機會。正如我所提到的,我們在美國已經擁有相當大的影響力,我們正在繼續投資,並且已經採取措施降低由於在岸化等舉措而造成的中斷和短缺風險,我們將繼續這些努力。我們也將繼續與政府合作,以確保最終做出的任何決定都經過深思熟慮,並就如何進行慎重考慮。
But David, anything you want to comment on transfer pricing and then I'll come back to BD.
但是大衛,如果你想對轉讓定價發表任何評論,然後我會回到 BD。
David Elkins - Executive Vice President, Chief Financial Officer
David Elkins - Executive Vice President, Chief Financial Officer
Yeah, so, Geoff, thanks for the question.
是的,傑夫,謝謝你的提問。
BMS, we have a really broad manufacturing network both in the US and globally, and we're not overly relying on any single country in terms of our supply chain. The situation relates to tariffs continues to evolve, and we're closely assessing. We have a cross-functional team in place that's evaluating the flexibility and we have a tremendous amount of flexibility to be able to move our manufacturing around should any potential tariffs come up. As we learn more and there's more specifics, obviously we'll update you when that becomes known, but as Chris said previously, we continue to ensure the administration as well as policymakers understand the impact of these tariffs and as well as any potential future actions both on patients as well as the industry.
BMS,我們在美國和全球都擁有非常廣泛的製造網絡,我們的供應鏈不會過度依賴任何一個國家。與關稅有關的情況仍在不斷演變,我們正在密切評估。我們有一個跨職能團隊負責評估彈性,如果出現任何潛在的關稅,我們擁有極大的靈活性來轉移我們的生產。隨著我們了解更多資訊和更多細節,我們顯然會在得知後立即向您通報,但正如克里斯之前所說,我們將繼續確保政府和政策制定者了解這些關稅的影響以及任何潛在的未來行動對患者和行業的影響。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
And then Geoff, with respect to business development, business development is our top capital allocation priority that includes both partnerships and acquisitions. And of course, as you note, we're going to source that innovation from wherever it comes, and there's certainly a lot of exciting innovation taking place in China.
然後,傑夫,關於業務發展,業務發展是我們最重要的資本配置重點,包括合作和收購。當然,正如您所說,我們將從任何地方獲取創新,而中國確實正在發生許多令人興奮的創新。
We're going to be focused on a few things though. We're going to be focused on strengthening our position in the core TAs that we operate in. That's bringing in promising areas of science, assets where we can improve the growth profile of the company. And what's important is that we like the science and we feel we're the rightful owners. The financials make sense and again that's strengthening the growth profile in key areas, and we believe that we can drive value for the company and shareholders. And if we hit those criteria, then we certainly have the financial ability to execute and move quickly.
不過,我們將重點放在一些事情上。我們將專注於加強我們在核心TA中的地位。這為我們帶來了有前景的科學領域和資產,可以改善公司的成長前景。重要的是,我們熱愛科學,我們認為自己是科學的合法擁有者。財務狀況合理,這再次加強了關鍵領域的成長前景,我們相信我們可以為公司和股東創造價值。如果我們達到這些標準,那麼我們肯定有財務能力來執行並快速行動。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
All right, thanks Chris. Next question please.
好的,謝謝克里斯。請問下一個問題。
Operator
Operator
Evan Seigerman, BMO Capital.
埃文·西格曼(Evan Seigerman),BMO Capital。
Evan Seigerman - Analyst
Evan Seigerman - Analyst
I wanted to touch on the rumblings we're hearing about the potential implementation of most favored nations' pricing potentially with regard to drug price negotiation, the IRA. I guess what are you hearing and more importantly, what's your stance on how that could impact negotiations for IRA on drug prices going forward?
我想談談我們聽到的關於在藥品價格談判中可能實施最惠國定價(IRA)的傳聞。我想您聽到了什麼?更重要的是,您對這將如何影響 IRA 未來關於藥品價格的談判持什麼立場?
And then secondary I'd love to touch on the potential impact, positive impact of the relaxed cardiac monitoring for CAMZYOS and how this could help accelerate sales with that franchise?
其次,我想談談放鬆心臟監測對 CAMZYOS 的潛在影響和正面影響,以及這如何幫助加速該特許經營的銷售?
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Well, let me start, Evan, thanks for the questions, and then I will turn it over to Adam on the second part of your question.
好吧,首先,埃文,謝謝你的提問,然後我會把問題的第二部分交給亞當。
Clearly, with respect to MFN and international reference pricing, there's a lot of focus here. I think the President and the administration is rightfully focused on the differential between US and ex-US net pricing. The way we think about it is I think you have to look at both sides of that equation.
顯然,最惠國待遇和國際參考定價是這裡關注的重點。我認為總統和政府正確地關注了美國和美國以外淨價格之間的差異。我認為,我們思考這個問題的方式是,你必須考慮等式的兩邊。
With respect to ex-US net prices, we actually agree with the administration. Countries outside of the US need to be allocating more healthcare spending to innovative medicines, so we're engaging directly with the administration, working with our pharma partners of course, and supporting the administration's efforts here to leverage whatever tools they can to get ex-US countries to allocate more of their health care spending to the types of innovative medicines that we developed at BMS.
對於美國以外的淨價格,我們實際上同意政府的意見。美國以外的國家需要將更多的醫療保健支出分配給創新藥物,因此我們直接與政府接觸,當然也與我們的製藥合作夥伴合作,並支持政府的努力,利用一切可能的手段讓美國以外的國家將更多的醫療保健支出分配給我們在 BMS 開發的創新藥物類型。
In terms of the US pricing environment, I think our perspective really is unchanged here. We have to address the complexity of the US health care system. $0.65 of every $1 spent on pharmaceutical products in the US goes to middlemen. These are entities that don't discover, develop, or deliver medicines to patients. These are entities that because of their market power also have control over what patients pay in terms of co-pays, and there are ample opportunities to make that system more complex and ensure that ultimately any rebates that we provide as industry are ultimately go to improve what patients ultimately have to pay for medicines.
就美國定價環境而言,我認為我們的觀點確實沒有改變。我們必須解決美國醫療保健系統的複雜性。美國每花 1 美元購買藥品,就有 0.65 美元流向中間商。這些實體並不發現、開發或向患者提供藥物。這些實體由於其市場力量,還可以控制患者支付的共同支付費用,並且有充足的機會使系統更加複雜,並確保最終我們作為行業提供的任何回扣最終都用於改善患者最終必須支付的藥品費用。
Beyond that, I would say we continue to be focused on addressing other aspects of health care, notably fixing some of the more egregious aspects of IRA, the pill penalty, and addressing spillover risk come top of mind there. And of course, we continue to be very focused on and concerned about abuses in the 340B program, and that's going to be a big focus area of ours as well.
除此之外,我想說,我們將繼續專注於解決醫療保健的其他方面,特別是修復 IRA 中的一些較惡劣的方面,藥丸懲罰,並解決溢出風險。當然,我們繼續高度關注和擔憂 340B 計劃中的濫用行為,這也將成為我們關注的重點領域。
Adam, do you want to take the second part of that question?
亞當,你想回答這個問題的第二部分嗎?
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Yeah. Thanks, Evan, for the question.
是的。謝謝埃文提出這個問題。
So we've continued to deliver strong growth for CAMZYOS. We've virtually doubled sales versus prior year in the quarter and our goal has been to ease the burden of echo requirements for both patients and physicians and based on our long-term clinical data as well as the robust data collection, our label change reflects the FDA's confidence in the safety and efficacy of CAMZYOS. Now with over 15,000 patients prescribed CAMZYOS in the United States.
因此,我們繼續為 CAMZYOS 帶來強勁成長。本季我們的銷售額幾乎比去年同期翻了一番,我們的目標是減輕患者和醫生的超音波檢查負擔,並且基於我們的長期臨床數據以及強大的數據收集,我們的標籤變化反映了 FDA 對 CAMZYOS 安全性和有效性的信心。目前,美國已有超過 15,000 名患者接受 CAMZYOS 治療。
So the label has been updated to reduce the frequency of echo monitoring for patients taking CAMZYOS from every 12 weeks, now to once every 6 months in the maintenance phase. And this is going to, number 1, simplify processes of both patients and physicians. Number 2, it's going to open up additional capacity at the COEs, and as a result, physicians are going to be able to treat more patients. It reduces the burden on patients and physicians' time and alleviates resourcing at the COEs. I will say that we're just super early in the launch, but early customer feedback has been very positive since the label change, and taken together, we're seeing good momentum for CAMZYOS and we expect continued strong growth.
因此,標籤已更新,將服用 CAMZYOS 的患者的超音波心動圖監測頻率從每 12 週一次減少到維持階段的每 6 個月一次。首先,這將簡化患者和醫生的診療流程。第二,它將為卓越中心釋放更多容量,從而使醫生能夠治療更多的患者。它減少了患者和醫生的時間負擔,並減輕了 COE 的資源負擔。我想說的是,我們才剛開始推出,但自從標籤更改以來,早期的客戶反饋一直非常積極,總的來說,我們看到了 CAMZYOS 的良好發展勢頭,我們預計它將繼續強勁增長。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks for the background, Adam.
謝謝你的背景介紹,亞當。
Next question, please.
請回答下一個問題。
Operator
Operator
Terence Flynn, Morgan Stanley.
摩根士丹利的特倫斯弗林。
Terence Flynn - Analyst
Terence Flynn - Analyst
I guess maybe two for me. First on the COBENFY launch, Adam, I was just wondering if you could elaborate a little bit on what you're seeing with the prescriber base right now in terms of kind of breadth and depth. And then, I know the slides also mentioned some one-time gross to net impact in the first quarter, so just wonder if you could elaborate on that and how we should think about the cadence of gross to net over the course of the year.
我想對我來說可能是兩個。首先,關於 COBENFY 的發布,亞當,我只是想知道您是否可以從廣度和深度的角度詳細說明您目前對處方者群體的觀察情況。然後,我知道投影片上也提到了第一季的一些一次性總額對淨額的影響,所以我想知道您是否可以詳細說明這一點,以及我們應該如何看待全年總額對淨額的節奏。
And then David, I was just, well I know you're not going to give 2026 guidance yet at this point, but again, heard you reiterate the 37% op margin for 2025. But just, directionally, how should we think about 2026 as it seems like there are still a number of moving pieces as we think about next year.
然後大衛,我只是,好吧,我知道你現在還不會給出 2026 年的指導,但是,再次聽到你重申 2025 年 37% 的營業利潤率。但是,從方向上看,我們應該如何看待 2026 年,因為當我們考慮明年時,似乎仍有許多不確定因素。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks for the questions, Terrence.
謝謝你的提問,特倫斯。
Adam, then David.
亞當,然後是大衛。
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Yeah, thanks, Terrence.
是的,謝謝,特倫斯。
So we're very pleased with COBENFY's launch performance. The launch is off to a strong start. We're now over 1,600 TRx's per week, and it's tracking ahead of all branded schizophrenia launch benchmarks. We've made very good progress achieving Medicaid and Medicare access. We're now at virtually 100% access across both channels, and we're making good progress with commercial payers. I mentioned earlier that because of this access, it's allowing us to move COBENFY up earlier in treatment, which is critical. And most importantly, we're hearing very encouraging feedback from both patients and physicians around COBENFY's efficacy and safety profile, physicians noting efficacy in positive symptoms, negative symptoms, and improvement in cognition and clarity of thought.
因此,我們對 COBENFY 的發布表現非常滿意。此次發布會開局良好。現在我們每週的交易量超過 1,600 個 TRx,並且領先於所有品牌精神分裂症產品的發布基準。我們在實現醫療補助和醫療保險方面取得了非常好的進展。現在,我們幾乎可以 100% 訪問這兩個管道,我們與商業付款人的合作也取得了良好的進展。我之前提到過,由於有了這種途徑,我們能夠更早地使用 COBENFY 進行治療,這一點至關重要。最重要的是,我們聽到了患者和醫生對 COBENFY 的功效和安全性的非常令人鼓舞的反饋,醫生指出 COBENFY 對陽性症狀、陰性症狀以及認知和思維清晰度的改善均有療效。
We're also, I think a critical metric for us is growing number of new trialists, and we're seeing consistent growth week over week in new trialists since launch, and we've got an opportunity to continue to expand and reach the 30,000 psychiatrists that are on our target list. And so as we've said, we expect to see strong uptake over the course of 2025 with a ramp in the back half of the year after we continue to increase the frequency of calls to our customers and try to break those reflexive habits, but we know the work we need to do to maximize this launch, and we will make this a very big product for the company over time.
我還認為,對我們來說一個關鍵指標是新試驗者數量的增長,自推出以來,我們每週都看到新試驗者的數量在持續增長,我們有機會繼續擴大規模,達到我們目標名單上的 30,000 名精神科醫生。正如我們所說的那樣,我們預計在 2025 年期間會出現強勁的增長勢頭,在我們繼續增加給客戶的電話頻率並嘗試打破這些反射習慣之後,下半年的增長將會加快,但我們知道我們需要做哪些工作才能最大限度地推廣這次發布,隨著時間的推移,我們將使它成為公司非常重要的產品。
Now as it relates to gross to nets, as you saw in the slides, we delivered $27 million in net sales for the quarter, and that was inclusive of $9 million in gross net benefit. So the underlying demand for COBENFY is strong, and at launch we made assumptions around payer mix and discounts. So Q1 essentially was a chew-up for favorable gross to nets in Q4. So we've been very disciplined in discretionary gross net spend. As you know, there are mandatory discounts in Medicaid. We now have very strong access, so we expect to see increases this year in gross nets for the full year. But again, we expect to see strong uptake over the course of the year with a ramp taking place in the back half of 2025.
現在,就毛銷售額與淨銷售額而言,正如您在幻燈片中看到的,我們本季的淨銷售額為 2,700 萬美元,其中包括 900 萬美元的毛淨收益。因此,COBENFY 的潛在需求強勁,並且在推出時我們對付款人組合和折扣做出了假設。因此,第一季的毛利潤與第四季的淨利潤基本上形成鮮明對比。因此,我們在可自由支配的總淨支出方面一直非常自律。如您所知,醫療補助中有強制折扣。我們現在擁有非常強大的管道,因此我們預計今年全年的總淨收入將會成長。但我們預計今年全年將出現強勁成長,並在 2025 年下半年出現上升。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
David?
戴維?
David Elkins - Executive Vice President, Chief Financial Officer
David Elkins - Executive Vice President, Chief Financial Officer
Great, and look, as far as 2026, we're not going to provide guidance on this call, but the way I would think about it is we remain very financially disciplined, by this strategic productivity initiatives that we've rolled out and as we said, we're well on our way this year to delivering $1 billion in savings relating to that and on track for that $2 billion by '27. So that gives us a lot of flexibility.
太好了,至於 2026 年,我們不會在這次電話會議上提供指導,但我認為,透過推出的戰略生產力舉措,我們將保持非常嚴格的財務紀律,正如我們所說的那樣,我們今年有望實現 10 億美元的節餘,並有望在 2027 年實現 20 億美元的節餘。這給了我們很大的靈活性。
Also, we continue to leverage AI and look to further automate, which is making us even more efficient, so we see greater opportunity there as well. And as we've shown in the past, we're constantly looking at our portfolio and prioritizing that accordingly.
此外,我們將繼續利用人工智慧並尋求進一步實現自動化,這將使我們更加高效,因此我們也看到了更大的機會。正如我們過去所展示的那樣,我們一直在關注我們的投資組合併相應地確定其優先順序。
So all of that being said, we feel we have a lot of levers to continue to manage this business, but at the same time, Terrence, we're going to invest in long-term growth of the company as well, and that's critically important to strengthen that growth position. And as we said, our cash position remains strong, business development remains a priority, so we look to bring in to strengthen that portfolio and bring in new assets which we'll invest behind.
所以綜上所述,我們覺得我們有很多手段可以繼續管理這項業務,但同時,特倫斯,我們也將投資於公司的長期成長,這對於加強這一成長地位至關重要。正如我們所說,我們的現金狀況仍然強勁,業務發展仍然是我們的首要任務,因此我們希望引入新資產來加強投資組合,並進行投資。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Great. Thanks, David.
偉大的。謝謝,大衛。
Next question, please.
請回答下一個問題。
Operator
Operator
Trung Huynh, UBS.
Trung Huynh,瑞銀。
Trung Huynh - Analyst
Trung Huynh - Analyst
Just a couple on CAMZYOS from me. So, one on the Alzheimer's psychosis trial, just what's your expectations for the bar for that study? What's a meaningful reduction in hallucinations and delusions we should be thinking about?
這只是我對 CAMZYOS 的一些看法。那麼,對於阿茲海默症精神病試驗,您對該研究的標準有什麼期望?我們應該考慮如何有效減少幻覺和妄想?
And then the second, just a clarification on the CAMZYOS's gross to net question. If you back out the COBENFY numbers, ex-that one off, it looks like gross to net is 35% to 40%. I think you just said that we should be thinking about that increasing, but you've also previously said you should have modest discounts above Medicaid statutory rate, which is like 23%. So are we thinking that gross to net increases from 35% to 40%? Are you having to be more aggressive on rebates for traction?
第二,只是對 CAMZYOS 的總額與淨額問題進行澄清。如果您撤回 COBENFY 數字(不包括那個數字),則看起來毛利率與淨利率之比為 35% 到 40%。我想您剛才說過我們應該考慮提高這個數字,但您之前也說過應該在醫療補助法定費率(例如 23%)之上給予適度折扣。那麼我們是否認為毛利率與淨利率比率會從 35% 上升到 40%?您是否必須更積極地提供回扣以吸引關注?
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Let me have Samit take the first part of your question, which I believe was on COBENFY, and then the second part of your question, I'll ask Adam to take.
讓我讓薩米特 (Samit) 回答您問題的第一部分,我相信該問題與 COBENFY 有關,然後問題的第二部分,我將請亞當 (Adam) 回答。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Yeah so for COBENFY ADP trial, remember these are trials that are being compared to placebo, and what we have to show is statistical significance in the primary endpoint for NCI hallucinations and delusions in this patient population. So we're not predefining as to what the real number needs to be to be clinically meaningful. I think over here, there are no drugs approved, so I think all improvements are good, but what we do know from the prior studies of xanomeline, there have been remarkable improvements not only on these symptomatologies but also other elements such as cognition. So we will continue to monitor that. The data will read out for the first trial in the second half of this year, so at that time we'll be able to share more.
是的,對於 COBENFY ADP 試驗,請記住這些是與安慰劑進行比較的試驗,我們必須證明的是該患者群體中 NCI 幻覺和妄想的主要終點具有統計意義。因此,我們無法預先定義具有臨床意義的實際數字是多少。我認為這裡還沒有批准任何藥物,所以我認為所有的改進都是好的,但是我們從之前對 xanomeline 的研究中了解到,不僅在這些症狀上,而且在認知等其他要素上都有了顯著的改善。因此我們將繼續監控此事。第一次試驗的數據將在今年下半年讀出,屆時我們將能夠分享更多資訊。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Adam?
亞當?
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Yeah, it relates to the growth nets, we don't share specific discounting rates, but as I mentioned, we've been very disciplined in discretionary gross net spend. And so when you look at the gross to net impact for the first quarter, what we saw this was just a chew-up for a projection that we made that was favorable in Q4. So we will have increased in gross to nets for the full year because we have now 100% access virtually in both Medicaid and Medicare.
是的,這與成長淨額有關,我們沒有分享具體的折扣率,但正如我所提到的,我們在可自由支配的總淨支出方面非常自律。因此,當您查看第一季的毛利對淨利的影響時,我們發現這只是對我們在第四季度做出的有利預測的削弱。因此,我們全年的總額與淨額將會增加,因為我們現在幾乎可以 100% 享受醫療補助和醫療保險。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thank you, Adam.
謝謝你,亞當。
Let's take our next question.
讓我們回答下一個問題。
Operator
Operator
Courtney Breen, Bernstein.
考特尼·布林,伯恩斯坦。
Courtney Breen - Analyst
Courtney Breen - Analyst
A couple from me, the first kind of as it relates that relates to tariffs, we've seen a number of companies come out and make statements about kind of their capital investments within the US in manufacturing and R&D kind of both backward looking as well as forward-looking. So I wonder if you could provide some comments on kind of Bristol's perspective there in terms of committed capital expenditure going forward.
我想提幾點,首先是與關稅相關的,我們已經看到許多公司站出來發表聲明,介紹他們在美國製造和研發方面的資本投資,既有回顧性的,也有前瞻性的。所以我想知道您是否可以對布里斯托爾在未來承諾的資本支出方面的看法發表一些評論。
And then the second question is just as we think about kind of M&A and I know there's been a couple of questions on this so far, you've also got some kind of key data cards to turn over. Milvexian, I think, is one of the big ones as well as some of these kind of subsequent COBENFY trials. And so can you talk a little bit about kind of how you're approaching making those M&A decisions in the context of kind of internal success rates and kind of waiting for sequencing of those data cards to turn over.
然後第二個問題是,正如我們考慮某種併購一樣,我知道到目前為止已經有了幾個關於這個問題的問題,你還需要移交一些關鍵數據卡。我認為,Milvexian 是其中一項重要試驗,也是一些後續的 COBENFY 試驗之一。那麼,您能否談談在內部成功率和等待資料卡排序的背景下,您是如何做出這些併購決策的?
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Sure, I'll take both of those.
當然,我會接受這兩個。
So first, as I mentioned earlier, we're a company that's significantly based in the US today. If you look back over the last number of years, we've been up-investing in core infrastructure that's infrastructure related to R&D technology as well as CapEx. And we certainly have plans to continue to invest in those very same areas in the US in the coming years.
首先,正如我之前提到的,我們是一家主要總部位於美國的公司。如果回顧過去幾年,我們一直在增加對核心基礎設施的投資,這些基礎設施與研發技術以及資本支出有關。我們當然計劃在未來幾年繼續在美國這些領域進行投資。
So again, what ultimately transpires with trade policies we hope will ultimately enhance the sector and support efforts like the ones that we've been making, and support the competitiveness of US companies.
因此,我們希望貿易政策最終能夠增強該行業並支持我們一直在做的努力,並支持美國公司的競爭力。
With respect to business development, obviously business development has been a priority for the company from a capital allocation standpoint for a number of years. It's going to continue to be our top allocation priority this year.
就業務發展而言,顯然從資本配置的角度來看,業務發展多年來一直是公司的首要任務。這將繼續是我們今年的首要分配重點。
If I step back and look at how we've thought about business development, we really don't think about it in terms of the relationship between specific data readouts of our own internal program. It's always been a way that we've thought about sourcing new science and new innovation. And so in some ways you can think about those things as very distinct.
如果我退一步看看我們是如何考慮業務發展的,我們實際上並沒有從我們自己的內部程序的具體數據讀數之間的關係的角度來考慮它。我們一直在思考尋找新科學和新創新的方法。因此從某種程度上來說,你可以認為這些事物是非常不同的。
When you look at what we've been doing over the last 18 months, we were very clear last year that we were going to focus on execution, we were going to focus on digesting the deals that we had done at the end of 2023, and most importantly, as part of that, ensuring that we got COBENFY off to a very strong launch. When I look at it, I think we delivered on all of those things.
回顧我們過去 18 個月所做的事情,你會發現去年我們非常清楚,我們將專注於執行,我們將專注於消化我們在 2023 年底達成的交易,最重要的是,作為其中的一部分,我們將確保 COBENFY 有一個非常強勁的推出。當我回顧它時,我認為我們已經實現了所有這些目標。
So as we think about this year, there's certainly no endogenous constraints or specific events that we have to see for us to be able to execute on business development. We're going to go back to the criteria I referenced earlier, the science looks good. If it's an area that we think we can add value and most importantly, if we believe it can enhance the growth profile for the company exiting this decade, we certainly have the financial horsepower to be able to execute and execute quickly.
因此,當我們思考今年時,我們肯定不需要看到任何內生限製或特定事件,就能開展業務發展。我們將回到我之前提到的標準,科學看起來不錯。如果我們認為我們可以在這個領域增加價值,最重要的是,如果我們相信它可以提升公司在未來十年的成長前景,那麼我們當然有足夠的財力來執行并快速執行。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks, Chris.
謝謝,克里斯。
Let's move to the next question.
我們來討論下一個問題。
Operator
Operator
Tim Anderson, Bank of America.
美國銀行的蒂姆·安德森。
Tim Anderson - Analyst
Tim Anderson - Analyst
I have a question on long-term guidance. So Chris, when you took over, you, kind of stopped, providing those or you guys kind of withdrew some of the elements that you had given. Can we expect you to revisit this at some point? I know on trough guidance you said end of the decade. I think the key there is, the absolute level of the trough number. So wondering if you can assure us that it won't go lower than $6 a share that's kind of where a lot of analyst numbers thought out.
我有一個關於長期指導的問題。所以克里斯,當你接手的時候,你就停止提供這些,或者你們撤回了一些你提供過的元素。我們可以期待您在某個時候重新審視這個問題嗎?我知道,根據指導,您說的是十年末。我認為關鍵在於谷底數字的絕對水準。所以我想知道您是否可以向我們保證股價不會低於每股 6 美元,這是許多分析師預測的水平。
And then the second question is just transfer pricing. So companies commonly have these set up with major brands, not all brands, levels of disclosure, next to nothing, any color you can share in which particular brands Bristol has transfer pricing arrangements in place such that if tariffs come through in Europe that [ensnares] this, we have some idea of which brands might be impacted.
第二個問題就是轉移定價。因此,公司通常會與主要品牌(並非所有品牌)設立這些機構,披露程度幾乎沒有,您可以分享哪些特定品牌布里斯托爾已製定轉讓定價安排,這樣,如果歐洲徵收關稅,我們就知道哪些品牌可能會受到影響。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Thanks for the questions, Tim. I'll start and then I'll turn it over to David to talk about transfer pricing.
謝謝你的提問,提姆。我先開始,然後交給大衛談轉讓定價。
We're not going to be giving long-term guidance as a standard course, and this is what we've discussed previously. That's a philosophical point of view. Our focus is as you know and as we've been discussing, is to drive sustained top-tier growth as we exit the decade. We've talked at length over the last 18 months about how we're going to deliver on that.
我們不會將長期指導作為標準課程,這是我們之前討論過的。這是一個哲學觀點。正如您所知以及我們一直在討論的那樣,我們的重點是推動未來十年持續的頂級成長。在過去的 18 個月裡,我們已經詳細討論瞭如何實現這一目標。
And the way we think about guidance, Tim, is we want to give you guidance that is a clear line of sight to the things that we're going to hold ourselves accountable for and that you can ultimately hold us accountable for and that's what we're going to do with respect to all of the guidance elements that that we've done so we.
提姆,我們對指導的看法是,我們希望為您提供清晰的指導,讓您了解我們要對自己負責的事情,並且您最終可以對我們負責,這就是我們將針對所有指導要素所做的。
We really have fixated on going back to what the company has done historically, which is to provide annual guidance. And then of course, as we did today, we update that guidance as the business conditions warrant.
我們確實專注於回顧公司過去所做的事情,即提供年度指導。當然,正如我們今天所做的那樣,我們會根據業務狀況更新該指南。
With respect to trough, I think that's going to -- how we talk about trough will be very aligned to that philosophy. But rest assured, the way we think about trough is we're going to do everything we can through either accelerating our internal clinical programs, continuing to engage in business development. And just executing across the enterprise to ensure that we do everything we can to shorten the depth of that trough, move it in as close as we can so that we can again return this company to sustained long-term growth and do that certainly by the time we exit this decade. David? do you want to talk about (multiple speakers)--
關於低谷,我認為——我們如何談論低谷將與這個理念非常一致。但請放心,我們考慮的方式是,我們將盡一切努力,要么加速我們的內部臨床項目,要么繼續從事業務發展。並且在整個企業範圍內執行,以確保我們盡一切努力縮短低谷的深度,盡可能地將其移近,以便我們能夠再次讓公司恢復持續的長期增長,並且肯定能夠在我們結束這個十年時做到這一點。戴維?你想談談(多位發言者)——
David Elkins - Executive Vice President, Chief Financial Officer
David Elkins - Executive Vice President, Chief Financial Officer
Tim, look, on transfer pricing, I know these question has come up a few times. Transfer prices are determined by tax law, both tax law in the United States as well as tax law in the other jurisdictions in which we operate. So from a tariff perspective, I would not be thinking transfer pricing. Transfer pricing is determined by tax laws and the jurisdictions in which we operate.
提姆,你看,關於轉讓定價,我知道這些問題已經出現過幾次了。轉讓價格由稅法決定,包括美國稅法以及我們營運所在的其他司法管轄區的稅法。因此從關稅的角度來看,我不會考慮轉讓定價。轉讓定價由稅法和我們經營所在地的司法管轄區決定。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks, David.
謝謝,大衛。
Let's move to the next question, operator.
接線員,我們來討論下一個問題。
Operator
Operator
David Risinger, Leerink Partners.
Leerink Partners 的 David Risinger。
David Risinger - Analyst
David Risinger - Analyst
Yes, thanks very much and thanks for all the updates. So I have two questions. First is high level and then one is on COBENFY.
是的,非常感謝,感謝所有的更新。我有兩個問題。首先是高水平,然後是 COBENFY。
So the industry is obviously facing three major government threats in the United States. Number one, actions that are harming US biopharma innovation, including HHS cuts and questioning and criticism of esteemed medical scientists. Second, tariff threats. And third, the Trump administration's agenda to take down drug prices more than the Biden administration.
因此,該產業顯然面臨美國政府的三大威脅。第一,損害美國生物製藥創新的行為,包括衛生與公共服務部削減開支以及對受人尊敬的醫學科學家的質疑和批評。第二,關稅威脅。第三,川普政府降低藥品價格的議程比拜登政府更積極。
So considering what appears to be a lack of appreciation in Washington on the benefits of the biopharma industry to the American public at large, and to the economy in the country, could you comment on how Bristol's leadership team and Board are engaging differently today with Washington to defend the industry and company?
因此,考慮到華盛頓似乎對生物製藥行業對廣大美國公眾和國家經濟的益處缺乏認識,您能否評論一下布里斯托爾的領導團隊和董事會今天如何以不同的方式與華盛頓接觸以捍衛該行業和公司?
And then separately regarding the COBENFY adjunctive trial failure, could you talk about the more disappointing results in the risperidone subgroup and whether the company believes that risperidone DDIs with COBENFY may have impacted the efficacy in that subgroup and how you may potentially evaluate COBENFY in combination with other therapies in the adjunctive setting in the future?
然後分別討論 COBENFY 輔助試驗失敗,您能否談談利培酮亞組中更令人失望的結果,以及公司是否認為利培酮與 COBENFY 的 DDI 可能影響了該亞組的療效,以及您將來如何評估 COBENFY 與輔助治療中的其他療法的聯合作用?
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Thanks for the questions, David. I'll ask Samit to start and then I'll come back and answer your more general questions.
謝謝你的提問,大衛。我會讓薩米特開始,然後我會回來回答你們比較一般的問題。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Sure, thank you, David, for the questions. So for our ARISE, certainly as David has already -- Chris has already mentioned, we saw a notable improvement in terms of band scores. If you think about patients who received the non-risperidone antipsychotic therapy. Certainly, we are evaluating and assessing all avenues in terms of understanding the data on risperidone population, including the DDI potentials and [PGP and 2D6] and all of those enzymatic pathways.
當然,謝謝你,大衛,提出這些問題。因此,對於我們的 ARISE,正如 David 已經提到的那樣——Chris 已經提到過,我們看到了樂隊得分方面的顯著提高。如果您想想接受非利培酮抗精神病治療的患者。當然,我們正在評估和評估所有途徑,以了解利培酮族群的數據,包括 DDI 潛力和 [PGP 和 2D6] 以及所有這些酵素途徑。
With all of that said, there is a lot more work to be done to look at other end points in the trial as well. Once all of that is done, then we will be able to define the next steps soon, which could include engaging. With the regulators, apart from obviously the treating physicians as well as conducting additional studies as we look to the future.
儘管如此,還有很多工作要做,以研究試驗中的其他終點。一旦所有這些都完成,我們就能很快地確定下一步行動,其中可能包括參與。除了治療醫師之外,監管機構也將進行更多研究,展望未來。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
And then with respect to your more general industry question, look, I think we agree with your perspective that America has a real gem in the biopharmaceutical industry. Over 70% of the research and development in this space takes place in the United States, and what drives that is a very healthy ecosystem that supports innovation, rewards innovation, and ultimately ensures that companies like ours can do everything we can to deliver innovative medicines to patients and do so quickly. Americans have benefited from having access to more innovation faster than patients anywhere else in the world.
然後關於您更普遍的行業問題,看,我認為我們同意您的觀點,即美國在生物製藥行業擁有真正的寶藏。該領域超過 70% 的研發都在美國進行,推動這一進程的是一個非常健康的生態系統,它支持創新、獎勵創新,並最終確保像我們這樣的公司能夠盡一切努力為患者提供創新藥物,並且速度很快。與世界其他任何地方的患者相比,美國人能夠更快地獲得更多創新,從而受益。
At the core of that is an ecosystem that starts with having strong government support for early research and also setting clear rules of engagement from a regulatory framework. Just to be clear, we have not seen a notable impact on our business from any of the changes taking place in Washington. We're obviously going to closely monitor implications of changes, but just to be clear, as of today, we've not seen any real impact on our business.
其核心是一個生態系統,首先是政府對早期研究的大力支持,然後從監管框架中製定明確的參與規則。需要明確的是,我們並未看到華盛頓發生的任何變化對我們的業務產生明顯影響。我們顯然會密切關注變化的影響,但需要明確的是,截至今天,我們還沒有看到對我們的業務產生任何實際影響。
Having said that, we're going to continue to do what we've always done, which is focus on strengthening the ecosystem for innovation in the US. That means ensuring that we are able to continue to invest in strong areas and interesting areas of science supported by a strong intellectual property framework. We're going to also continue to engage with the government on pricing and the support of the payment for innovation on the back end. We've talked about the need to fix the more egregious aspects of IRA, notably the pill penalty and addressing some of the spillover risks that we saw in IRA.
話雖如此,我們將繼續做我們一直在做的事情,那就是專注於加強美國的創新生態系統。這意味著確保我們能夠繼續投資於強大的智慧財產權框架所支援的優勢領域和有趣的科學領域。我們也將繼續與政府就定價和後端創新支付支援進行合作。我們討論了修復 IRA 更惡劣方面的必要性,特別是藥丸懲罰,以及解決我們在 IRA 中看到的一些溢出風險。
We also want to ensure that we're making the US ecosystem less complex. That means addressing the role that middlemen play. And then an area that we absolutely agree with this administration is outside of the US getting countries to allocate more healthcare dollars to support innovative medicines like those that we make at Bristol-Myers Squibb. So those are really our main areas of focus. We're going to continue to engage with our pharma partners to engage the administration. We'll also be engaging directly, and that's going to be our continued focus.
我們也希望確保美國的生態系統變得不那麼複雜。這意味著要解決中間人所扮演的角色。我們完全同意本屆政府的一個意見,那就是在美國以外,讓其他國家撥出更多的醫療保健資金來支持像百時美施貴寶公司生產的創新藥物。所以這些確實是我們關注的重點領域。我們將繼續與我們的製藥合作夥伴合作,以參與政府工作。我們也將直接參與,這將是我們持續關注的重點。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thank you, Chris. Let's take our next question, please.
謝謝你,克里斯。請讓我們回答下一個問題。
Operator
Operator
Carter Gould, Cantor Fitzgerald.
卡特古爾德、康托費茲傑拉。
Carter Gould - Analyst
Carter Gould - Analyst
The BD messaging is coming through clear, and the focus on that endogenous events won't be a stage gate is clear. I guess my question is more on exogenous events and the extent to which uncertainty around tariffs, FDA, drug pricing environment are stage gates to being able to move on drug pricing either a hold-up on your side or on the target side.
BD 訊息傳達得很清晰,並且重點明確了內生事件不會成為階段門。我想我的問題更多的是關於外部事件,以及關稅、FDA、藥品定價環境的不確定性在多大程度上成為推動藥品定價的階段性門檻,無論是您這邊的阻礙還是目標方面的阻礙。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
I'll take that one, Carter.
我會接受這個,卡特。
I think you mean that any of those exogenous factors having an impact on our ability to do business development. Look, I think, we clearly have been focused on putting ourselves in a very strong financial position. We do that by, frankly executing on the business as you saw us do in this quarter that we've been discussing today.
我認為您的意思是任何外部因素都會影響我們開展業務的能力。看,我認為,我們顯然一直致力於使自己處於非常強大的財務狀況。我們透過坦率地執行業務來做到這一點,正如您看到我們在本季所做的那樣,我們今天一直在討論。
But also, as David referenced, by continuing to focus on making the company more efficient and more agile, that enables us to pull costs out of the system and puts us in a stronger position. That financial flexibility gives us the ability to be much more engaged on business development and frankly, that I think is way more important than any of the exogenous factors that you referenced.
但同時,正如戴維所提到的,透過繼續專注於提高公司效率和靈活性,我們能夠降低系統成本,並使我們處於更有利的地位。這種財務靈活性使我們有能力更多地參與業務發展,坦白說,我認為這比您提到的任何外部因素都重要得多。
And so again I would just reiterate business development remains our top priority. We have the financial position to move on business development, but we're also going to be very disciplined. We're going to stay focused on those opportunities where we like the science, where we're the rightful owners, and importantly where we can continue to improve the growth profile of the company.
因此,我再次重申,業務發展仍然是我們的首要任務。我們擁有推動業務發展的財務狀況,但我們也會非常自律。我們將繼續專注於那些我們喜歡的科學、我們是合法所有者的機會,更重要的是,我們可以繼續改善公司的成長狀況。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thank you, Chris. Let's take our next question.
謝謝你,克里斯。讓我們回答下一個問題。
Operator
Operator
Steve Scala, TD Cowen.
史蒂夫·斯卡拉 (Steve Scala),TD Cowen。
Steve Scala - Analyst
Steve Scala - Analyst
Two questions, probably both for Samit.
兩個問題,可能都是問薩米特的。
Just to be absolutely clear on your prepared remarks and answers to questions, and I know that you need to speak with regulators, but Bristol seems to see a path to positive regulatory action on the existing ARISE data. Is that correct or is there no such path?
為了絕對清楚地說明您準備好的發言和對問題的回答,我知道您需要與監管機構溝通,但布里斯托爾似乎看到了對現有 ARISE 數據採取積極監管行動的途徑。這是正確的嗎或沒有這樣的路徑?
So that's the first question. Second question is to what extent did the Milvexian Phase 3 trial benefit from the competitor Phase 3 stoppage, for instance? Did enrollment jump 10%, 20%? And given that, why hasn't timing of the primary endpoint changed? Were events, for instance, running behind in the patients previously enrolled before the competitor setback.
這是第一個問題。第二個問題是,例如,Milvexian 第 3 階段試驗在多大程度上受益於競爭對手第 3 階段試驗的停止?入學人數是否增加了 10% 或 20%?既然如此,為什麼主要終點的時間沒有改變?例如,在競爭對手受挫之前,先前招募的患者是否有落後的情況。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Samit, do you want to take those?
薩米特,你想拿走那些嗎?
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Yeah, thank you, Steve. As usual, great questions.
是的,謝謝你,史蒂夫。像往常一樣,很棒的問題。
For ARISE, look, we would not obviously speculate right now. As I said earlier, we do need to do all of the work to understand all of the data, including the additional endpoints that we have not yet looked at. And we will plan to then engage with the regulators to define what the next steps would be.
對於 ARISE,我們現在顯然不會進行推測。正如我之前所說,我們確實需要做所有工作來了解所有數據,包括我們尚未研究的其他端點。我們計劃與監管機構合作,確定下一步措施。
For Milvexian, we certainly continue to manage and monitor the events that we are observing. As we've said before, our overall event rate remains very low for atrial fibrillation trial. We have not re-projected the timelines. We will continue to work together, J&J and ourselves, and we will communicate if there is a change in the timeline in terms of the readout.
對於 Milvexian,我們當然會繼續管理和監控我們正在觀察的事件。正如我們之前所說,我們的心房顫動試驗的總體事件發生率仍然很低。我們尚未重新規劃時間表。我們將繼續與強生公司和我們自己合作,如果時間表上的讀數發生變化,我們將進行溝通。
As you know, we've already communicated, but we still look forward to the readout for the ACN SSP trial in 2026, and then AF is in 2027. We've already completed enrollment. We've communicated that as well for the AF trial. So overall all on the right track, and we'll keep you posted if the timelines were to change with the evolution of the events.
如您所知,我們已經進行過溝通,但我們仍然期待 2026 年 ACN SSP 試驗的讀數,然後 AF 將在 2027 年讀數。我們已經完成報名了。我們也已就 AF 試驗傳達了這個訊息。所以總的來說一切都在正確的軌道上,如果時間表隨著事件的發展而變化,我們會及時通知您。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Right, thanks, Samit.
好的,謝謝,薩米特。
Next question, please.
請回答下一個問題。
Operator
Operator
Seamus Fernandez, Guggenheim.
謝默斯·費爾南德斯,古根漢美術館。
Zach Dunn - Analyst
Zach Dunn - Analyst
This is Zach Dunn on for Seamus Fernandez. Thank you for the questions.
這是 Zach Dunn 取代 Seamus Fernandez 上場的演出。謝謝您的提問。
A few from us on CAMZYOS and your CMI portfolio. Firstly, how defensible is your first-in-class position with CAMZYOS such as your establishment at HCM centers and updated REMs in light of aficamten potentially coming to market this year?
我們提供了一些有關 CAMZYOS 和您的 CMI 產品組合的資訊。首先,鑑於 aficamten 可能在今年上市,您在 CAMZYOS 中的一流地位(例如您在 HCM 中心的建立和更新的 REM)的穩固性如何?
And then to non-obstructive HCM and myosin inhibition, what read through, if any, might there be to your development efforts in HFpEF? How would you characterize prospects for success in HFpEF with MYK-224?
然後對於非阻塞性 HCM 和肌球蛋白抑制,如果有的話,對您在 HFpEF 方面的開發工作可能有什麼影響?您如何看待 MYK-224 治療 HFpEF 的成功前景?
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Thanks, both great questions. Adam and Samit.
謝謝,這兩個問題都很棒。亞當和薩米特。
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Yeah, let me start. Thanks for the question.
是的,讓我開始吧。謝謝你的提問。
So as I mentioned, we continue to deliver strong growth and steady growth with CAMZYOS. We've established a very strong revenue base and expect continued growth from expanding our prescriber base. We're seeing very high persistency, so long durations of treatment, and we're continuing to add new patients each and every week. We're focused right now on increasing our depth of prescribing in the large COEs, and the label change that we mentioned earlier should help accelerate that. We're also making good progress expanding into community of cardiology accounts, and we're seeing solid growth, and increasing number of trialists each and every week.
正如我所提到的,我們將繼續透過 CAMZYOS 實現強勁成長和穩定成長。我們已經建立了非常強大的收入基礎,並期望透過擴大處方基礎來實現持續成長。我們看到了非常高的持久性,因此治療時間很長,而且我們每週都在繼續增加新患者。我們現在專注於增加大型 COE 中的處方深度,而我們之前提到的標籤變更應該有助於加速這一進程。我們在擴展心臟病學帳戶社群方面也取得了良好的進展,我們看到了穩定的成長,每週的試驗者數量都在增加。
As it relates to competition, we've always planned for competition in the space. We don't see any meaningful clinical differentiation versus at the aficamten. We've now had the opportunity to talk to literally hundreds of thought leaders, and almost all have said that aficamten and the data that they presented appears undifferentiated. So it's going to be important to see what their date and their label looks like later in the year. But we'll be prepared for when aficamten comes to market we maintain a consistent view that we will remain leaders in this space.
就競爭而言,我們一直在為該領域的競爭做準備。與 aficamten 相比,我們沒有看到任何有意義的臨床差異。現在,我們有機會與數百位思想領袖進行交談,幾乎所有人都表示,aficamten 和他們提供的數據似乎沒有區別。因此,了解今年稍後它們的日期和標籤是什麼樣子非常重要。但我們將為 aficamten 上市做好準備,我們始終堅信我們將繼續保持這一領域的領先地位。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Yeah, and thank you for the question on the NHCM results and the impact on HFpEF for MYK-224. Look, we still have to do a lot more digging into the data, as Chris has mentioned. We do know obstructive hypertrophic cardiomyopathy versus a non-obstructive hypertrophic cardiomyopathy, there's a suggestion of a differential disease because of the outflow tract obstruction in one versus the other.
是的,感謝您提出有關 NHCM 結果以及 MYK-224 對 HFpEF 的影響的問題。正如克里斯提到的那樣,我們仍然需要對數據進行更多的挖掘。我們確實知道阻塞性肥厚型心肌病變與非阻塞性肥厚型心肌病變,由於其中一種疾病的流出道阻塞與另一種疾病的流出道阻塞有差異。
As it relates to HFpEF, remember how NHCM study was designed and where we had seen the impact on the biomarkers, NT-proBNP as well as on the troponin T. We had hoped that those changes in the biomarkers will translate into a clinical benefit and outcome in NHCM did not happen. However, as we think about HFpEF, these biomarkers have tracked historically as we think about the other trials in HFpEF and other drugs that have worked in HFpEF as we think about the overall functionality of the heart.
由於它與 HFpEF 相關,請記住 NHCM 研究是如何設計的,以及我們在其中看到了對生物標記、NT-proBNP 以及肌鈣蛋白 T 的影響。我們曾希望這些生物標記的變化能夠轉化為 NHCM 的臨床益處和結果,但這並沒有發生。然而,當我們思考 HFpEF 時,這些生物標記已經進行了歷史追踪,當我們思考 HFpEF 中的其他試驗和在 HFpEF 中起作用的其他藥物時,當我們思考心臟的整體功能時。
So it's too early to say what the outcome is going to look like. We are conducting a large cohort of -- we are enrolling a large cohort of patients in the Phase 2b -- Phase 2a study that we are conducting right now for MYK-224. Once those results are available, then we'll be able to say more. The impact overall on the HFpEF program, I think it's too early to comment on that.
因此現在判斷結果還為時過早。我們正在進行一項大規模隊列研究——我們正在招募大量患者參與我們目前正在進行的 MYK-224 第 2b 至 2a 期研究。一旦獲得這些結果,我們就能透露更多資訊。對於 HFpEF 計劃的整體影響,我認為現在評論還為時過早。
Operator
Operator
Asad Haider, Goldman Sachs.
高盛的阿薩德·海德爾 (Asad Haider)。
Asad Haider - Analyst
Asad Haider - Analyst
Maybe just going back to capital allocation and I know a lot has been answered already, but just if you could just unpack, Chris, what's driving this renewed emphasis on BD, if you could unpack that a little bit more in the context of the lack of visibility on some of the structural challenges that the industry is facing and then any comments on size and what exactly you're looking to solve for as you scan the landscape of external assets. Is it near-term revenue growth or earlier-stage assets and what are the therapeutic areas of interest?
也許只是回到資本配置問題,我知道很多問題已經得到解答,但是克里斯,如果你可以解釋一下,是什麼推動了對 BD 的重新重視,如果你可以在缺乏對行業面臨的一些結構性挑戰的了解的背景下進一步解釋這一點,然後對規模有什麼評論,以及當你掃描外部資產狀況時你到底想解決什麼問題。這是近期收入成長還是早期資產,以及感興趣的治療領域是什麼?
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Sure, well, let me be really clear. Capital allocation focus, the focus that we have hasn't changed. Business development is a top priority. We said that last quarter and the quarter before that. We are focused on strengthening in our key therapeutic areas that we know well and improving the growth profile of the company. Those are the things that I think we've consistently said.
當然,好吧,讓我說清楚。資本配置重點,我們的重點沒有改變。業務發展是重中之重。我們在上個季度和上個季度都說過這一點。我們專注於加強我們熟悉的關鍵治療領域並改善公司的成長前景。我認為這些都是我們一直在說的話。
With respect to size, we don't evaluate opportunities focusing on size. What I would say is that the way we think about any opportunity from a business development standpoint is we put it through a set of filters. We're in a strong position to do a lot of things, but the way we think about it is does it strengthen the therapeutic areas that we're in, and you know those well.
就規模而言,我們不會根據規模來評估機會。我想說的是,從業務發展的角度考慮任何機會時,我們都會對其進行一系列篩選。我們有能力做很多事情,但我們考慮的是它是否能加強我們所處的治療領域,而這些你都很清楚。
Are the areas where we have an ability to add to the science and we're the rightful owners of it? Do the financials make sense? And the one thing that we've been consistent in overlaying on those criteria is does it improve the growth profile of the company at the back end of the decade and going into the 2030s, and those are the criteria that we've consistently been using, and those will be the main priorities.
我們是否有能力為這些領域的科學做出貢獻,而我們是這些領域的合法所有者?財務狀況合理嗎?我們在這些標準上始終堅持的一點是,它是否能改善公司在本世紀末和 2030 年代的成長狀況,這些是我們一貫使用的標準,也是我們的主要優先事項。
Of course around that we'll continue to look for opportunities for earlier stage programs, but I would say that's how we think about our top priorities right now.
當然,我們會繼續尋找早期專案的機會,但我想說,這就是我們現在考慮的首要任務。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks, Chris.
謝謝,克里斯。
Next question, please.
請回答下一個問題。
Operator
Operator
Matt Phipps, William Blair.
馬特菲普斯、威廉布萊爾。
Matt Phipps - Analyst
Matt Phipps - Analyst
Two quick ones. I know it's early days, but any particular indications or physician settings where you're seeing more adoption or more interest in Qvantig so far?
兩個簡單的。我知道現在還為時過早,但到目前為止,您是否看到任何特定跡像或醫生環境對 Qvantig 有更多的採用或更感興趣?
And then independent styles coming up. Just how meaningful is this market opportunity expansion and can you give us any sense of what would be a clinically meaningful benefit and transfusion independence.
然後獨立風格就出現了。這個市場機會擴張到底有多大意義?您能否告訴我們什麼才是具有臨床意義的益處和輸血獨立性?
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Adam?
亞當?
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Yeah, Matt, thanks for the question. We're making good progress with Opdivo Qvantig. We're now around three months post launch. The feedback's been positive. What we're seeing is the majority of the youth thus far has been in the community setting, about 80% as expected, and we're focused on continuing to increase breadth of prescribing and doing that both in community and in academic settings. What's encouraging is we're seeing physicians use Opdivo Qvantig across multiple tumor types, and so as a result, the uptake is tracking right in line with their expectations.
是的,馬特,謝謝你的提問。Opdivo Qvantig 的研發進展順利。目前距離發布已經過了三個月左右。反饋是正面的。我們看到,到目前為止,大多數年輕人都在社區環境中接受治療,預計約為 80%,我們致力於繼續擴大處方範圍,並在社區和學術環境中開展此類工作。令人鼓舞的是,我們看到醫生在多種腫瘤類型中使用 Opdivo Qvantig,因此,其吸收情況與他們的預期完全一致。
So the last thing I'll mention is what we have shared previously. We were issued a temporary J-code like all Part B biologics, and that does impact reimbursement timing. And so some accounts are waiting on the sidelines for a permanent J-code. Therefore, sub-2 conversion will take time to ramp. We'll get that J-code July 1 issued and thus we expect the second half ramp. So overall, we're pleased with what we're seeing in the early days of the launch.
我要提到的最後一件事是我們之前分享過的內容。與所有 B 部分生物製劑一樣,我們也獲得了臨時 J 代碼,這確實會影響報銷時間。因此,一些帳戶正在等待永久的 J 代碼。因此,sub-2 轉換需要時間來提升。我們將於 7 月 1 日發布 J 代碼,因此我們預計下半年會出現成長。總的來說,我們對發布初期的表現感到滿意。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
And I think the second question was regarding MF overall opportunities, so (multiple speakers)--
我認為第二個問題是關於 MF 的整體機會,所以(多位發言者)——
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
I could take that, too. So thanks for the question.
我也可以接受。感謝您的提問。
So as it relates to myelofibrosis and anemia associated MF for REBLOZYL. The opportunity there is a pretty modest commercial opportunity. The majority of the business for REBLOZYL is going to be driven by the indication we have from commands, and that's first line. Our teams are focused on really driving that first-line RS negative patient. We're making good progress in the United States. We're also unlocking reimbursement outside of the US as well, so we expect continued growth there.
因此,它與 REBLOZYL 的骨髓纖維化和貧血相關 MF 有關。那裡的機會是一個相當適度的商業機會。REBLOZYL 的大部分業務將由我們從命令中獲得的指示驅動,這是第一行。我們的團隊致力於真正推動第一線 RS 陰性患者的發展。我們在美國取得了良好的進展。我們也在美國以外地區解鎖了報銷業務,因此我們預計那裡將繼續成長。
The next readout for REBLOZYL that's going to be important is to be the non-transfusion dependent readout will open up another part of the marketplace, but again, we're focused on really driving the indications that we have today in first line. Thanks Adam.
REBLOZYL 的下一個重要讀數是非輸血依賴性讀數,它將打開市場的另一部分,但同樣,我們專注於真正推動我們今天在第一線的適應症。謝謝亞當。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks, Adam. Let's move to our next question.
謝謝,亞當。讓我們進入下一個問題。
Operator
Operator
Sean McCutcheon, Raymond James.
肖恩麥卡琴、雷蒙德詹姆斯。
Sean McCutcheon - Analyst
Sean McCutcheon - Analyst
So for the EXCALIBER study with MRD negativity readout later in the year, do you suspect that you could be able to obtain an approval on that MRD negativity outcome as an intermediate endpoint? And with the movement of CAR-T into second line and later, how do you think this shapes the opportunity, and the bar for utilization of iberdomide in the triplet if it does show benefit over DVD?
那麼,對於今年稍後進行的具有 MRD 陰性讀數的 EXCALIBER 研究,您是否懷疑您能夠獲得將該 MRD 陰性結果作為中期終點的批准?隨著 CAR-T 進入二線及以後的治療,您認為這會如何影響三聯療法中使用伊貝多胺的機會和門檻(如果它確實比 DVD 更有優勢)?
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks for the question, Sean. Samit, you can start and then Adam maybe weigh in on the latter part of that question.
謝謝你的提問,肖恩。薩米特,你可以開始,然後亞當可能會對這個問題的後半部分發表意見。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Sure. So remember the trial is designed with MRD and then there's the PFS and then there's overall survival as end points and again very important study for the second-line-plus population. The overall, as we look at the MRD data, we would have to look at the totality of the data that other end points are moving in the right direction because the supportive evidence would be needed from a regulatory perspective as the regulators look at this, that the other end points are not going in the opposite direction. So again, when the data reads out, we'll be able to say more in terms of the regulatory possibility.
當然。因此請記住,試驗的設計以 MRD 為目標,然後是 PFS,然後是總體生存期作為終點,這對於二線加治療人群來說又是非常重要的研究。總體而言,當我們查看 MRD 數據時,我們必須查看其他終點是否朝著正確方向發展的總體數據,因為從監管角度來看,監管機構需要支持性證據,以確保其他終點沒有朝著相反的方向發展。因此,當數據讀出來時,我們將能夠就監管可能性說更多。
I'll just add one more thing in terms of the placement of iberdomide once the data are read out and if they're positive and the drug gets approved. Remember, we've talked about it before as well. CAR cell therapies are still limited to academic centers. There's a large amount of patients who are treated in the community setting. So small molecules and combinations are going to be required in the community setting and therefore, there is that unmet medical need that will be fulfilled with iberdomide and in the future mezigdomide as well.
一旦數據讀出並且結果呈陽性並且該藥物獲得批准,我只想補充一點關於伊貝多胺的放置情況。記住,我們之前也討論過這個問題。CAR細胞療法仍僅限於學術中心。有大量患者在社區環境中接受治療。因此,社區環境中將需要小分子和組合藥物,因此存在未滿足的醫療需求,而伊貝多胺和未來的美齊多胺將滿足這一需求。
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Adam Lenkowsky - Executive Vice President, Chief Commercialization Officer, Member of the Leadership Team
Yeah, thank you, Samit.
是的,謝謝你,薩米特。
So as you know this is a very crowded, competitive market, but as Samit was alluding to, it's a very fragmented market as well with a lot of room for additional entrance. So yes, cell therapies are moving up in lines of treatment, but they are moving up in treatment in these CAR T centers of excellence which represent a relatively small percentage of the market. In fact, the majority of the market, over 70% of multiple myeloma, is treated in the community as Samit was alluding to.
所以,正如你所知,這是一個非常擁擠、競爭激烈的市場,但正如薩米特所暗示的,這也是一個非常分散的市場,有很大的進入空間。所以是的,細胞療法在治療領域正在不斷進步,但它們在 CAR T 卓越中心的治療領域正在不斷進步,而這些中心所佔的市場份額相對較小。事實上,正如薩米特所暗示的,市面上大部分的多發性骨髓瘤患者(超過 70%)都是在社區接受治療的。
What we're excited about for the novel CELMoD agents in multiple myeloma is that number one, they provide a tailored approach of efficacy with a manageable toxicity profile, combinability as well as an oral convenience. Samit talked about we've got four ongoing pivotal trials across iber and mezi. For iberdomide, it's a triplet combination, combining well with dara as well as moving even further upline head to head versus REVLIMID in a post-transplant maintenance setting.
我們對多發性骨髓瘤新型 CELMoD 藥物感到興奮的一點是,首先,它們提供了一種量身定制的療效方法,具有可控的毒性、可組合性以及口服的便利性。薩米特 (Samit) 表示,我們在 Iber 和 Mezi 正在進行四項關鍵試驗。對於伊貝多胺來說,它是一個三聯療法,可以與達拉 (dara) 很好地結合,甚至可以在移植後維持治療中與 REVLIMID 進行更進一步的正面交鋒。
And for the EXCALIBER study or (inaudible), there's a lot of excitement there around the potency of mezigdomide which has the opportunity to read out as well potentially in early 2026. This is our most potent CELMoD combining well and triple combination with PI. So take it together, we're excited about the potential launches of these important assets.
對於 EXCALIBER 研究或(聽不清楚),人們對美齊多胺的效力非常興奮,該藥物有可能在 2026 年初得到結果。這是我們最強大的 CELMoD,與 PI 結合良好且三重組合。所以綜合起來,我們對這些重要資產的潛在推出感到興奮。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
All right. Thanks, Adam.
好的。謝謝,亞當。
Let's move to the next question, please.
請讓我們進入下一個問題。
Operator
Operator
Srikripa Devarakonda, Truist Securities.
Sriripa Devarakonda,Truist 證券公司。
Srikripa Devarakonda - Analyst
Srikripa Devarakonda - Analyst
I have one question on your radio franchise and then maybe a big picture question. Can you talk about expectations from grades 101 in first-line small cell lung cancer that's expected later this year? And then maybe a big picture FDA question, the FDA commissioner has recently made a lot of comments on his vision for changes at the FDA at different levels. Was there anything in particular that you think might have a significant impact on either the timelines or how you do drug development or post-marketing surveillance?
我對您的廣播特許經營權有一個問題,然後可能還有一個大問題。您能談談今年稍後預計的一線小細胞肺癌 101 級治療的期望嗎?然後也許是一個關於 FDA 的大問題,FDA 局長最近就他對 FDA 不同層面變革的願景發表了許多評論。您認為有什麼特別的事情可能會對時間表或藥物開發或上市後監測的方式產生重大影響嗎?
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks for the questions, Srikripa. Maybe Samit, you could take both of those.
謝謝你的提問,Srikripa。也許薩米特,你可以接受這兩個。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Yeah, thank you, Srikripa.
是的,謝謝你,Srikripa。
So yes, truly looking forward to the readout of the Phase 1 study in extensive stage small-cell lung cancer, where the (inaudible) therapy has been combined with the background of chemotherapy, and what we're really looking for is primarily the safety and certainly efficacy will be looked at but again with an open-label study and single arm study, you'll have to compare that to the historical controls to see what the overall efficacy looks like, where chemotherapy does work well, but the durability has generally been challenging in terms of maintaining that response.
所以是的,我們非常期待廣泛期小細胞肺癌 I 期研究的結果,其中(聽不清)療法與化療相結合,我們真正關注的主要是安全性,當然也會關注療效,但再次進行開放標籤研究和單臂研究,您必須將其與歷史對照進行比較,以了解整體療效如何,化療確實有效,但在維持這種反應方面的持久性通常具有挑戰性。
All of that data is what we're expecting to see as we look towards the back end of this year as the trial reads out, and that will then set up the stage for taking it further in patients with SSDR2 expression in their small-cell lung cancer.
隨著今年年底試驗結果的公佈,我們期待看到所有這些數據,這將為在小細胞肺癌中表達 SSDR2 的患者中進一步開展研究奠定基礎。
From the FDA perspective, look, I think thus far what we've seen from our perspective that our approvals have come on time. In fact, some of the approvals have come before time if you think about the first-line HCC approval that we recently got as well as for the MSI-high colorectal cancer approval. Our meetings for -- across therapeutic areas continue to be on time. Some of them are actually in person now going forward.
從 FDA 的角度來看,我認為到目前為止,從我們的角度來看,我們的批准是按時進行的。事實上,如果你想想我們最近獲得的一線 HCC 批准以及 MSI 高結腸直腸癌批准,你會發現有些批准已經提前到來了。我們各個治療領域的會議繼續準時舉行。他們中的一些人實際上現在已經親自前往了。
So overall we are very constructively and collaboratively working with the regulators to ensure that transformational therapies that we are developing are not delayed, and we will certainly continue to work with the administration as well as the regulators to convey the point if we start to see any change in those timelines for any of the activities that are going to be critical to bring these medicines to patients on time.
因此,總體而言,我們正在與監管機構進行非常建設性的合作,以確保我們正在開發的轉化療法不會延遲,如果我們開始看到這些活動的時間表發生任何變化,我們肯定會繼續與政府和監管機構合作,傳達這一點,這些活動對於按時將這些藥物帶給患者至關重要。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks, Samit.
謝謝,薩米特。
Next question, please.
請回答下一個問題。
Operator
Operator
James Shin, Deutsche Bank.
德意志銀行的詹姆斯辛 (James Shin)。
James Shin - Analyst
James Shin - Analyst
One for Chris. Sorry to belabor macro, Chris, but totally -- I totally understand the backdrop is still fluid. But is there an initial data point or policy decision that will inform next steps? For example, would having visibility on US corporate tax reform be a starting point or would you need the actual form of tariff rates or any color like that to budget accordingly.
一份給克里斯。很抱歉過多談論宏觀問題,克里斯,但完全——我完全理解背景仍然是不斷變化的。但是,是否存在可以指導下一步的初始數據點或政策決策?例如,了解美國企業稅改革是否是一個起點,或者您是否需要實際形式的關稅稅率或類似的顏色來相應地進行預算。
And then one for Samit. What are your thoughts on the recent PD-1/VEGF data sets? Specifically, does the data look consistent? Does it look competitive to PD-1? Just get your views there.
然後是 Samit 的一封信。您對最近的 PD-1/VEGF 資料集有何看法?具體來說,數據看起來是否一致?它看起來能與 PD-1 競爭嗎?只需在那裡表達你的觀點即可。
Christopher Boerner - Board Chair and Chief Executive Officer
Christopher Boerner - Board Chair and Chief Executive Officer
Maybe I'll start and then Samit, you can take over.
也許我先開始,然後 Samit,你接手。
Look, I think that there are multiple aspects of the policy environment that are in flux and we're going to be monitoring each and every one of those. I don't think there's one that rises to a more prominence than the other. They're all important at some level.
看,我認為政策環境的多個面向都在不斷變化,我們將對每一個面向進行監控。我認為沒有哪一個會比另一個更突出。在某種程度上它們都很重要。
What I would say if you just step back though, if the goal here is to ensure that we continue to invest in research and development and that we're investing in the United States, one thing we should not overlook is one of the comments -- one of the points you just made, which is the importance of tax policy. The US tax rate and making the US corporate tax rate more competitive is critically important.
不過,我想說的是,如果你退一步來看,如果我們的目標是確保我們繼續投資於研發,並且我們在美國進行投資,那麼我們不應該忽視的一件事就是你剛才提到的一個觀點,那就是稅收政策的重要性。美國稅率以及使美國企業稅率更具競爭力至關重要。
In fact, when you go back to 2017 and the corporate tax rate came down to 21%, you saw a positive impact on investment in the United States in R&D. And so I think that in the focus that a lot of folks have on tariffs and on what may happen in the US, the next US pricing environment, we shouldn't lose sight of the importance of tax.
事實上,當你回顧2017年,企業稅率降至21%時,你會看到這對美國研發投資產生了正面的影響。因此我認為,當許多人關注關稅以及美國未來可能發生的情況和美國未來的定價環境時,我們不應該忽視稅收的重要性。
Samit?
薩米特?
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
I think from the PD-1, VEGF perspective, the data continues to evolve in the right direction, I would say. What we saw yesterday or the day before when the news broke out for an additional Phase 3 study in China showing a progression-free survival benefit. One of the things that we'll continue to watch out for is when does that OS data start to become available and what the overall impact on overall survival is going to look like.
我認為從 PD-1、VEGF 的角度來看,數據正在繼續朝著正確的方向發展。昨天或前天,我們看到了中國一項額外的 3 期臨床試驗的新聞,該試驗顯示了無進展生存期的益處。我們將持續關注的事情之一是 OS 數據何時開始可用,以及對整體生存的整體影響將會是什麼樣的。
Second thing to watch out is going to be what is the impact on safety. Right now, it seems at least from the press release we saw is it's comparable between the two arms, so we'll have to just look at those parameters.
要注意的第二件事是其對安全有何影響。現在,至少從我們看到的新聞稿來看,這兩個方案似乎是可比的,所以我們只需要看看這些參數。
As it applies to us, I would just close it out from that perspective that we have a large portfolio in non-small cell lung cancer, which is obviously precision driven as well as looking at overall portfolio also building on the IO franchise as we think about the high-dose of (inaudible) combination with Opdivo. So we have a lot of work to do in non-small cell lung cancer, and but we certainly keep an eye on these data.
就我們的情況而言,我只想從這個角度結束討論,我們在非小細胞肺癌領域擁有大量投資組合,這顯然是精準驅動的,同時著眼於整體投資組合,也建立在 IO 特許經營權的基礎上,因為我們考慮與 Opdivo 的高劑量(聽不清)組合。因此,我們在非小細胞肺癌方面還有很多工作要做,但我們肯定會密切關注這些數據。
Chuck Triano - Senior Vice President and Head of Investor Relations
Chuck Triano - Senior Vice President and Head of Investor Relations
Thanks, Samit.
謝謝,薩米特。
We know you all have a busy day, so if I can just turn to Chris for some closing remarks, then we'll wrap up the call. Yeah.
我們知道你們今天都很忙,所以如果我可以讓克里斯做一些結束語,那麼我們就可以結束通話了。是的。
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Samit Hirawat - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team
Yeah, so thanks a lot, Chuck.
是的,非常感謝,查克。
We do know that you all have a very busy day. There are several companies in our sector that are reporting, and we certainly appreciate everyone's attention. I hope it was clear throughout our messaging that the priorities that we have as a company remain consistent and clear.
我們知道你們今天都非常忙碌。我們產業中有幾家公司正在報告,我們當然感謝大家的關注。我希望透過我們的訊息傳遞能夠清楚地表明,我們作為一家公司的優先事項始終保持一致和明確。
I think what you see in the quarters our growth portfolio is delivering. We've shown good progress. We're better aligning our cost structure with our revenue base, and many of our key pipeline readouts remain in front of us. In fact, we are just at the very beginning of the wave of catalysts that we have coming.
我認為您在季度中看到的是我們的成長投資組合正在發揮作用。我們已經取得了良好的進展。我們正在更好地調整成本結構和收入基礎,並且許多關鍵的管道讀數仍然擺在我們面前。事實上,我們正處於即將到來的催化劑浪潮的開始階段。
We're in a strong financial position which affords us options in terms of capital allocation priorities and business development. And before we close, I want to recognize our colleagues for all of their hard work and of course, even in these uncertain times, we remain committed to our overarching goal, which is to reshape and optimize BMS to deliver top-tier growth by the end of the decade and most importantly, generate attractive returns for shareholders. So again, thank you all for tuning in today and as always, the team's available for follow-ups and have a great rest of the week.
我們的財務狀況良好,這為我們在資本配置優先順序和業務發展方面提供了選擇。在結束之前,我想感謝我們同事們的辛勤工作,當然,即使在這些不確定的時期,我們仍然致力於我們的總體目標,即重塑和優化 BMS,以在十年末實現頂級增長,最重要的是,為股東創造可觀的回報。所以,再次感謝大家今天的收看,與往常一樣,團隊將隨時為您提供跟進服務,祝大家本週剩餘時間過得愉快。
Operator
Operator
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。