AstraZeneca PLC (AZN) 2025 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good morning to those joining from the UK and the US. Good afternoon to those in Central Europe. And good evening to those listening in Asia. Welcome, ladies and gentlemen, to AstraZeneca's Q1 2025 results conference call for investors and analysts.

    來自英國和美國的各位嘉賓早安。中歐地區的朋友們下午好。亞洲的聽眾大家晚上好。女士們、先生們,歡迎參加阿斯特捷利康 2025 年第一季投資者和分析師業績電話會議。

  • Before I hand over to AstraZeneca, I'd like to read the Safe Harbor statement. The company intends to utilize the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995. This meeting may contain forward-looking statements with respect to the operations and financial performance of AstraZeneca.

    在將權力移交給阿斯特捷利康之前,我想先讀安全港聲明。該公司打算利用 1995 年美國私人證券訴訟改革法案的安全港條款。本次會議可能包含有關阿斯特捷利康營運和財務表現的前瞻性陳述。

  • Although we believe our expectations are based on reasonable assumptions, by their very nature, forward-looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call. The company undertakes no obligation to update forward-looking statements.

    儘管我們相信我們的預期是基於合理的假設,但前瞻性陳述本身涉及風險和不確定性,並且可能受到導致實際結果與這些前瞻性陳述所表達或暗示的結果有重大差異的因素的影響。本次電話會議中所做的任何前瞻性陳述均反映本次電話會議時所掌握的知識和資訊。該公司不承擔更新前瞻性陳述的義務。

  • Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this conference call. (Operator Instructions) I must advise you, this presentation is being recorded today.

    也請仔細閱讀本次電話會議幻燈片中的前瞻性聲明免責聲明。(操作員指示)我必須通知您,今天正在錄製此演示。

  • And with that, I will now hand you over to Andy Barnett, Head of Investor Relations.

    現在,我將把您交給投資者關係主管安迪巴內特 (Andy Barnett)。

  • Andy Barnett - Head of Investor Relations

    Andy Barnett - Head of Investor Relations

  • A warm welcome to AstraZeneca's first-quarter 2025 presentation conference call and webcast for investors and analysts. I'm Andy Barnett, Head of Investor Relations. And before I hand over to Pascal and other members of our executive team, I'd like to cover some housekeeping items.

    熱烈歡迎投資者和分析師參加阿斯特捷利康 2025 年第一季示範電話會議和網路直播。我是投資者關係主管安迪巴內特 (Andy Barnett)。在將工作交給帕斯卡和我們執行團隊的其他成員之前,我想先談談一些日常事務。

  • Firstly, all of the materials presented today are available on AstraZeneca's Investor Relations website. This slide contains our Safe Harbor statement, which I'd encourage you to take the time to read. We will be making comments on our performance using constant exchange rates, or CER; core financial numbers; and other non-GAAP measures. A non-GAAP to GAAP reconciliation is contained within the results announcement. All numbers quoted are in millions of US dollars unless otherwise stated.

    首先,今天提供的所有資料均可在阿斯特捷利康的投資者關係網站上找到。這張投影片包含我們的安全港聲明,我鼓勵您花時間閱讀。我們將使用恆定匯率(CER)對我們的表現做出評論;核心財務數據;以及其他非公認會計準則衡量指標。績效公告中包含非公認會計準則與公認會計準則的對帳。除非另有說明,所有引用的數字均以百萬美元為單位。

  • This slide shows our agenda for the call. And following our prepared remarks, we'll open the line for questions. As usual, we'll try to address as many questions as we can during the call, although please limit the number of questions you ask to allow others a fair chance to participate in the Q&A. And with that, I'll hand over to Pascal.

    這張投影片展示了我們這次通話的議程。在我們準備好發言之後,我們將開放提問熱線。像往常一樣,我們會嘗試在通話中解答盡可能多的問題,但請限制您提出的問題數量,以便其他人有公平的機會參與問答。說完這些,我就把麥克風交給帕斯卡。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Andy, and welcome, everybody. We have made a strong start in the first quarter of the year, building on the momentum through 2024. Total revenue growth was 10% in the quarter, reflecting increasing demand for our innovative medicines. Core operating profit increased by 12% and core EPS increased by 21%, reflecting our continued focus on operating leverage, although core EPS in the fourth quarter did benefit from a lower tax rate due to settlements in certain jurisdictions.

    謝謝你,安迪,歡迎大家。我們在今年第一季取得了良好的開端,並將保持這一勢頭直至 2024 年。本季總收入成長了 10%,反映出對我們創新藥物的需求不斷增長。核心營業利潤成長了 12%,核心每股收益成長了 21%,這反映了我們對經營槓桿的持續關注,儘管第四季的核心每股收益確實受益於某些司法管轄區結算導致的較低稅率。

  • Since our full-year results in February, we secured 13 approvals in key regions across our diverse portfolio, a clear illustration of the value our medicines bring to patients globally.

    自 2 月公佈全年業績以來,我們多元化產品組合在關鍵地區獲得了 13 項批准,這清楚地表明了我們的藥品為全球患者帶來的價值。

  • In addition, we continue to see strong delivery from our pipeline. And in the past few months announced five positive Phase III results including two NMEs, and enaboparatide and multiple high-value indication expansion opportunities across gastric and breast cancers.

    此外,我們的管道交付繼續保持強勁勢頭。並在過去幾個月中宣布了五項積極的 III 期結果,其中包括兩種 NME、enaboparatide 以及胃癌和乳腺癌領域的多個高價值適應症擴展機會。

  • We're making excellent progress towards our ambition to deliver at least 20 NMEs by 2030, with the recent approval of Beyonttra, formerly known as acoramidis, marking the ninth novel medicine approval towards our goal.

    我們在實現到 2030 年推出至少 20 種 NME 的目標方面取得了巨大進展,其中 Beyonttra(原名 acoramidis)最近獲得批准,標誌著我們朝著目標邁出了第九個新藥批准。

  • We continue to benefit from our broad-based divert business with a robust growth outlook for each of our therapy areas and across key geographies. We saw strong performances across key regions despite anticipated headwinds including Medicare Part D redesign in the US. Importantly, we continue to deliver impressive growth in the emerging markets with ex China revenues up 17% reflecting the benefit of our sustained presence in this market.

    我們繼續受益於廣泛的轉移業務,我們每個治療領域和主要地區都擁有強勁的成長前景。儘管預期存在包括美國醫療保險 D 部分重新設計在內的不利因素,但我們在主要地區仍表現強勁。重要的是,我們繼續在新興市場實現令人矚目的成長,中國以外的收入成長了 17%,反映了我們在該市場的持續存在帶來的好處。

  • Our growth in China was also encouraging, up 5% or 9% when adjusting for the decline of Pulmicort sales. This growth is driven by increasing demand for innovative medicines with additional launches in China achieved in the first quarter. We are aiming to deliver sustained growth well beyond 2030, investing in transformative technologies. In the third quarter, we announced several business development transactions that strengthen our pipeline and our capabilities which we believe have potential to support our long-term growth ambitions.

    我們在中國的成長也令人鼓舞,在調整 Pulmicort 銷售額下滑後,成長了 5% 或 9%。這一增長是由對創新藥物不斷增長的需求推動的,第一季中國又推出了更多創新藥物。我們的目標是透過投資變革性技術,實現 2030 年以後的持續成長。在第三季度,我們宣布了幾項業務發展交易,這些交易增強了我們的產品線和能力,我們相信這些交易有潛力支持我們的長期成長目標。

  • Our proposed acquisition of EsoBiotec brings a potentially best-in-class in-vivo cell therapy platform in-house increasing accessibility of potentially curative cell therapies with applications across oncology and autoimmune diseases.

    我們擬收購 EsoBiotec,這將為我們帶來潛在的最佳體內細胞治療平台,從而提高潛在治癒性細胞療法的可及性,並應用於腫瘤學和自體免疫疾病。

  • Next, we enhanced our portfolio of novel modalities accelerating the development of multi-specific biologics and macrocyclic peptides across a wide range of diseases. We also announced an exclusive license for ALT-B4 with Alteogen to deliver subcutaneous formulations of multiple oncology assets with the aim of making our treatments easier to administer and more convenient for patients.

    接下來,我們增強了新模式組合,加速了針對多種疾病的多特異性生物製劑和大環肽的開發。我們還宣布與 Alteogen 達成 ALT-B4 的獨家許可,以提供多種腫瘤資產的皮下製劑,旨在使我們的治療更易於管理並為患者提供更多便利。

  • Finally, we announced the recent investment in Beijing, China, where we establish our 6th strategic R&D center. The pace of medical and scientific innovation in Beijing is impressive, and our new R&D center will enable us to foster and strengthen collaborations within the local ecosystem as well as attract world-class talent in China to discover and develop new transformative medicines.

    最後,我們宣布最近在中國北京的投資,並在那裡建立了我們的第六個戰略研發中心。北京的醫療和科學創新步伐令人印象深刻,我們的新研發中心將使我們能夠促進和加強當地生態系統內的合作,並吸引中國的世界級人才來發現和開發新的變革性藥物。

  • To support our growth across the major geographies around the world, over the last few years, we have been building a broad manufacturing network covering the US, Europe, and China. Our global presence makes our business highly resilient to regional disruptions, effectively providing a natural hedge.

    為了支持我們在全球主要地區的成長,過去幾年來,我們一直在建立一個覆蓋美國、歐洲和中國的廣泛製造網路。我們的全球影響力使我們的業務對區域性幹擾具有很強的抵禦能力,有效地提供了自然對沖。

  • We now have 31 manufacturing sites globally, supply for the vast majority of our medicines. Our supply chains for China and the US are largely segregated, and we have very limited commercialized finished medicines imported from the US to China, meaning that our exposure to the current China tariffs on pharmaceuticals is not material in the context of the group.

    我們目前在全球擁有 31 個生產基地,供應我們絕大多數的藥品。我們針對中國和美國的供應鏈基本上是分開的,我們從美國進口到中國的商業化成品藥品非常有限,這意味著我們對當前中國藥品關稅的影響對集團而言並不重要。

  • We have a substantial and growing manufacturing footprint in the US We currently have 11 manufacturing sites in the country and the vast majority of our medicines sold in the US are made domestically. We do import a minority of medicines sold in the US from Europe. However, mitigations are already underway.

    我們在美國擁有龐大且不斷成長的製造足跡,目前我們在美國擁有 11 個生產基地,並且我們在美國銷售的絕大多數藥品都是在美國生產的。我們確實從歐洲進口了少數在美國銷售的藥品。然而,緩解措施已在實施中。

  • As a result, we believe that if tariffs were implemented in the range we've seen recently in other industries on medicines imported from Europe to the US, we would remain within the guidance range we indicated for 2025, in part due to our ongoing inventory management.

    因此,我們認為,如果對從歐洲進口到美國的藥品徵收與我們最近在其他行業看到的一樣的關稅,我們將保持在我們為 2025 年指出的指導範圍內,部分原因是我們正在進行庫存管理。

  • Beyond 2025, the impact on the minority of medicines imported from Europe would be time limited, as we are shifting manufacturing of these medicines to sites in the US We will, of course, provide updates as appropriate.

    2025 年以後,對從歐洲進口的少數藥物的影響將是時間有限的,因為我們正在將這些藥物的生產轉移到美國的工廠。當然,我們會適時提供更新資訊。

  • And with that, I will hand over to Aradhana to take us through our financials. Please advance to the next slide.

    接下來,我將把時間交給 Aradhana,讓他來為我們解釋財務狀況。請前進到下一張幻燈片。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Thank you, Pascal, and good morning, everyone. As usual, I will start with our reported P&L. Next slide.

    謝謝你,帕斯卡,大家早安。像往常一樣,我將從報告的損益表開始。下一張投影片。

  • As Pascal highlighted, total revenue grew by 10% in the first quarter. Product sales grew by 9% with growth seen in all major regions. Alliance revenue, mainly consisting of Enhertu and test buyer profit shares increased by 42% to $639 million.

    正如帕斯卡所強調的,第一季總收入成長了 10%。產品銷售額成長了 9%,所有主要地區均出現成長。聯盟收入(主要包括 Enhertu 和測試買家利潤份額)成長 42%,達到 6.39 億美元。

  • Starting this quarter, we are presenting a new line in our P&L called Product Revenue. This is the sum of product sales and alliance revenue, which better characterizes the performance of sustainable revenue both from products sold by AstraZeneca and revenue share from partnered products. Product revenue grew by 10% in the first quarter.

    從本季開始,我們將在損益表中引入一項名為「產品收入」的新內容。這是產品銷售額和聯盟收入的總和,更好地表徵了阿斯特捷利康銷售的產品和合作產品的收入份額的可持續收入表現。第一季產品收入成長了10%。

  • Next slide. Turning to our core P&L, we saw a total revenue gross margin of 84% in the first quarter, benefiting from product sales mix and some favorable FX movements. Please note that we will report gross margin based on total revenue going forward rather than product sales. The gross margin percentage based on total revenue reflects the totality of the cost associated with creating it including pay aways to our alliance partners of gross profit shares that are booked in the cost of sales relating to markets where AstraZeneca leads commercialization and books product sales.

    下一張投影片。談到我們的核心損益表,我們看到第一季的總收入毛利率為 84%,受益於產品銷售組合和一些有利的外匯走勢。請注意,我們將根據未來的總收入而不是產品銷售額來報告毛利率。基於總收入的毛利率百分比反映了與創造總收入相關的全部成本,包括向我們的聯盟合作夥伴支付的毛利份額,這些份額計入阿斯特捷利康在商業化方面處於領先地位並預定產品銷售的市場相關的銷售成本中。

  • As previously stated, in relation to product sales gross margin, we anticipate that total revenue gross margin will decline around 60 to 70 basis points in 2025. The decline is driven by the Part D redesign, anticipated VBP inclusions in China, SOLIRIS biosimilar competition and increased profit share relating to partnered products.

    如前所述,就產品銷售毛利率而言,我們預計 2025 年總收入毛利率將下降約 60 至 70 個基點。下降的原因是 D 部分的重新設計、預期在中國納入 VBP、SOLIRIS 生物相似藥的競爭以及與合作產品相關的利潤份額的增加。

  • We anticipate a lower gross margin in the second half of the year, driven by some of these such as VBP as well as the usual seasonal pattern for certain medicines, such as FluMist.

    我們預計下半年毛利率會下降,原因是 VBP 等一些藥物以及 FluMist 等某些藥物的常見季節性模式。

  • Total operating expenses increased by 9% in the first quarter, below top line growth of 10%. Core R&D costs increased by 16% and represented 23% of total revenue, driven by new trial starts and investments in transformative technologies such as cell therapy. We continue to anticipate core R&D cost to be in the low 20s percentage range for the full year.

    第一季總營運費用成長了 9%,低於 10% 的營收增幅。核心研發成本成長了 16%,佔總收入的 23%,這得益於新試驗的開始和對細胞療法等變革性技術的投資。我們繼續預計全年核心研發成本將維持在 20% 左右。

  • Core SG&A costs increased by 4% and as anticipated, continued to grow at a slower rate than total revenue. The core operating profit margin was 35% supported by favorable cost phasing and a higher gross margin this quarter.

    核心銷售、一般及行政費用增加了 4%,正如預期的那樣,其成長速度繼續低於總收入。本季度,受有利的成本分階段和更高的毛利率支撐,核心營業利潤率為 35%。

  • Similar to prior years, we anticipate a lower margin in the following quarters, primarily relating to the gross margin effect I mentioned above.

    與前幾年類似,我們預計接下來幾季的利潤率會下降,這主要與我上面提到的毛利率效應有關。

  • The core tax rate was 16%, benefiting from a favorable settlement in the quarter and is anticipated to remain 18% to 22% for the full year. Core EPS of $2.49 represents a CER growth rate of 21%.

    核心稅率為 16%,受益於本季的有利結算,預計全年將保持在 18% 至 22% 之間。核心每股收益 2.49 美元,代表 CER 成長率為 21%。

  • Next slide. Our cash flow continues to improve. Cash inflows from operating activities increased to $3.7 billion in the quarter. We saw CapEx of approximately $500 million, which will increase in future quarters and we continue to anticipate CapEx to increase by around 50% this year versus 2024.

    下一張投影片。我們的現金流持續改善。本季經營活動現金流入增加至 37 億美元。我們看到資本支出約為 5 億美元,未來幾季還將增加,我們繼續預計今年的資本支出將比 2024 年增加約 50%。

  • Deal payments of around $800 million included $175 million milestone payable to Daiichi Sankyo for Enhertu DESTINY-Breast06 US approval. Our net debt increased by $1.5 billion to $26.1 million, with the increase driven by the dividend payment of $3.3 billion in the first quarter.

    該交易支付了約 8 億美元的款項,其中包括向第一三共支付的 1.75 億美元里程碑款項,用於獲得 Enhertu DESTINY-Breast06 的美國批准。我們的淨債務增加了 15 億美元,達到 2,610 萬美元,這一增長是由於第一季支付了 33 億美元的股息。

  • We remain comfortable with our level of debt and the current net debt to adjusted EBITDA ratio stands at 1.5x. Building on Pascal's comments earlier, we are reiterating our full year 2025 guidance, anticipating total revenue growth of high single-digit percentage and core EPS growth of low double-digit percentage at constant exchange rates.

    我們對我們的債務水準感到滿意,當前淨債務與調整後 EBITDA 比率為 1.5 倍。基於帕斯卡先前的評論,我們重申 2025 年全年指引,預計以固定匯率計算,總收入成長率將達到高個位數百分比,核心每股收益成長率將達到低兩位數百分比。

  • Based on the March average FX rates, we continue to anticipate a low single-digit percentage adverse impact on total revenue and have updated our FX guidance for core EPS to low single-digit adverse impact previously mid-single digit.

    根據 3 月的平均外匯匯率,我們繼續預期總收入將受到低個位數百分比的不利影響,並已將核心每股收益的外匯預測更新為低個位數不利影響(先前為中個位數)。

  • With that, please advance to the next slide, and I will hand over to Dave, who will take you through the performance of our oncology and hematology business.

    接下來,請進入下一張投影片,我將把時間交給戴夫,他將向您介紹我們的腫瘤學和血液學業務的表現。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thank you, Aradhana. Next slide, please. Oncology total revenues grew 13% in the first quarter to $5.6 billion with strong double-digit growth across the US, Europe and emerging markets. Turning now to quarterly performance for our key medicines. I'd like to talk first about our oral oncolytics performance in the US, which includes Tagrisso, Calquence, Lynparza and Truqap.

    謝謝你,阿拉達納。請看下一張投影片。第一季腫瘤學總營收成長 13%,達到 56 億美元,美國、歐洲和新興市場均實現了強勁的兩位數成長。現在來談談我們主要藥物的季度表現。我想先談談我們在美國口服溶瘤藥物的表現,其中包括 Tagrisso、Calquence、Lynparza 和 Truqap。

  • Across these medicines, we saw an increase in the proportion of Medicare Part D patients following implementation of the $2,000 co-pay cap, which led to fewer patients on free goods and increased adherence. These dynamics helped to partially offset the gross to net impact following Part D redesign.

    在這些藥物中,我們發現在實施 2,000 美元的共同支付上限後,醫療保險 D 部分患者的比例有所增加,這導致免費藥品的患者減少,依從性提高。這些動態有助於部分抵消 D 部分重新設計後的總影響到淨影響。

  • Tagrisso delivered 8% growth in the first quarter, reflecting strong demand across all indications, including accelerating demand for FLAURA2 in the US and Europe and strong launch uptake for LAURA in unresectable Stage III setting.

    Tagrisso 在第一季實現了 8% 的成長,反映出所有適應症的強勁需求,包括美國和歐洲對 FLAURA2 的需求加速成長,以及 LAURA 在無法切除的 III 期疾病中的強勁上市需求。

  • Strong underlying demand in Europe was partially impacted by pricing pressure in certain major markets, and we anticipate continued growth over the balance of the year across all indications.

    歐洲強勁的潛在需求部分受到某些主要市場價格壓力的影響,我們預計今年餘下時間裡所有指標都將繼續成長。

  • Calquence total revenues increased 8% in the first quarter. Starting with the US, volumes increased over 20%, reflecting sustained BTK inhibitor leadership in frontline chronic lymphocytic leukemia and accelerating launch momentum for ECHO in mantle cell lymphoma. Following recent Medicare affordability improvements, the proportion of Medicare Part D Calquence patients has increased by 10 percentage points over the past year.

    Calquence 第一季總營收成長了 8%。從美國開始,銷售量成長了 20% 以上,反映了 BTK 抑制劑在慢性淋巴球白血病一線治療的持續領先地位,以及 ECHO 在套細胞淋巴瘤治療領域的加速推出動能。隨著近期醫療保險可負擔性的提高,醫療保險 D 部分 Calquence 患者的比例在過去一年中增加了 10 個百分點。

  • In Europe, Calquence continues to gain market share in an increasingly competitive environment. Looking ahead, we see potential for meaningful new growth opportunities, including the fixed duration AMPLIFY regimen in CLL and continued demand for ECHO and MCL.

    在歐洲,Calquence 在日益激烈的競爭環境中繼續獲得市場份額。展望未來,我們看到了有意義的新成長機會的潛力,包括 CLL 中的固定期限 AMPLIFY 方案以及對 ECHO 和 MCL 的持續需求。

  • Lynparza remains the leading PARP inhibitor globally with 5% growth in the first quarter. We anticipate further volume growth globally which will help offset pricing pressure in Europe and the potential impact of VBP inclusion in China, which we expect from the middle of the year.

    Lynparza 仍然是全球領先的 PARP 抑制劑,第一季成長了 5%。我們預計全球銷售將進一步成長,這將有助於抵消歐洲的價格壓力以及中國從今年年中開始納入 VBP 的潛在影響。

  • (inaudible) million in first quarter revenues and is now approved in all major markets. In the US, continued market leadership in the (inaudible) biomarker altered population was offset by destocking of the blister pack following the inventory buildup in the fourth quarter. Impressively, one year post launch, Truqap has achieved nearly 100% market share in the AKT P10 biomarker altered population with additional opportunity for growth in the PIK3CA population.

    (聽不清楚)第一季營收達數百萬美元,目前已在所有主要市場獲得批准。在美國,第四季庫存增加後泡罩包裝的去庫存化抵消了(聽不清楚)生物標記改變人群的持續市場領先地位。令人印象深刻的是,上市一年後,Truqap 在 AKT P10 生物標記改變人群中取得了近 100% 的市場份額,並且在 PIK3CA 人群中還有額外的增長機會。

  • Turning now to the rest of our portfolio. Imfinzi and Imjudo delivered 16% and 13% growth, respectively, reflecting continued demand in lung and liver cancers across major markets. We look forward to expanding Imfinzi adoption in bladder and lung cancers following recent approvals for NIAGARA, ADRIATIC and AEGEAN in the US and Europe.

    現在來談談我們投資組合的其餘部分。Imfinzi 和 Imjudo 分別實現了 16% 和 13% 的成長,反映了主要市場對肺癌和肝癌的持續需求。繼 NIAGARA、ADRIATIC 和 AEGEAN 在美國和歐洲獲得批准後,我們期待擴大 Imfinzi 在膀胱癌和肺癌治療中的應用。

  • Enhertu total revenues grew 34% in the first quarter, reflecting continued market leadership for DESTINY-Breast03 and 04 as well as impressive growth in China following NRDL enlistment in January.

    Enhertu 在第一季總營收成長 34%,反映出 DESTINY-Breast03 和 04 繼續保持市場領先地位,以及自 1 月納入國家醫保目錄以來在中國市場取得了令人矚目的成長。

  • We continue to see encouraging launch momentum for DESTINY-Breast06 in the US and are excited about the recent European approval, which will help move Enhertu into chemo-naive and HER2 ultra-low settings.

    我們繼續看到 DESTINY-Breast06 在美國令人鼓舞的上市勢頭,並對最近在歐洲獲得的批准感到興奮,這將有助於 Enhertu 進入化療初治和 HER2 超低環境。

  • We're off to an encouraging start with the launch of Datroway in hormone receptor positive HER2-negative breast cancer. Feedback from the breast cancer community reinforces the improved convenience and favorable GI toxicity profile seen with Datroway in the TROPION-Breast01 trial. We're excited about the outlook for our oncology portfolio over the balance of the year as we continue to expand the reach of our transformative medicines.

    隨著 Datroway 在荷爾蒙受體陽性 HER2 陰性乳癌中的推出,我們迎來了一個令人鼓舞的開端。來自乳癌界的回饋進一步證實了在 TROPION-Breast01 試驗中 Datroway 所表現出的便利性和良好的胃腸道毒性特徵。隨著我們繼續擴大變革性藥物的覆蓋範圍,我們對今年剩餘時間腫瘤學產品組合的前景感到興奮。

  • With that, please advance to the next slide, and I'll hand over to Susan to cover key R&D highlights from the quarter.

    接下來,請進入下一張投影片,我將交給蘇珊來介紹本季的主要研發亮點。

  • Susan Galbraith - Executive Vice President - Oncology and Research and Development

    Susan Galbraith - Executive Vice President - Oncology and Research and Development

  • Thank you, Dave. Over the past few months, we've had several key oncology data readouts that mark important steps towards achieving our 2030 ambition. In February, we were very excited to announce the positive high-level results for camizestrant the first next-generation oral SERD to have a positive readout in the first-line setting in hormone receptor-positive metastatic breast cancer with emerging ESR1 mutations.

    謝謝你,戴夫。在過去的幾個月裡,我們獲得了幾份關鍵的腫瘤學數據,這標誌著我們朝著實現 2030 年目標邁出了重要一步。今年 2 月,我們非常高興地宣布,卡米司群是第一個在荷爾蒙受體陽性轉移性乳癌(伴隨新出現的 ESR1 突變)的一線治療中取得積極結果的下一代口服 SERD。

  • SERENA-6 demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival. And whilst time to second progression and overall survival remain immature, a trend to improvement in time to second progression was also observed.

    SERENA-6 在無惡化存活期方面表現出了具有高度統計學意義和臨床意義的改善。雖然第二次進展時間和整體存活率仍不成熟,但也觀察到第二次進展時間改善的趨勢。

  • This trial also demonstrated the combinability of camizestrant with three CDK4/6 inhibitors and show that the combinations are well tolerated. SERENA-6 is the first step to establishing camizestrant as the endocrine backbone of choice across ER-positive breast cancer setting and has the potential to redefine treatment for patients with HR-positive metastatic breast cancer and emerging ESR1 mutations.

    該試驗也證明了卡米司群與三種 CDK4/6 抑制劑的可組合性,並顯示這些組合具有良好的耐受性。SERENA-6 是將卡米司群確立為 ER 陽性乳癌治療中首選內分泌治療藥物的第一步,並有可能重新定義 HR 陽性轉移性乳癌和新出現的 ESR1 突變患者的治療方法。

  • Last month, we were delighted to share positive high-level results for MATTERHORN, a key indication expansion opportunity for Imfinzi. In MATTERHORN, perioperative Imfinzi in combination with FLOT chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival as well as a strong trend in overall survival versus perioperative chemotherapy alone in patients with resectable early stage and locally advanced gastric and gastroesophageal junction cancers.

    上個月,我們很高興分享了 MATTERHORN 的積極高水準成果,這是 Imfinzi 的關鍵適應症擴展機會。在 MATTERHORN 研究中,對於可切除的早期和局部晚期胃癌和胃食道連接部癌患者,圍手術期 Imfinzi 聯合 FLOT 化療在無事件生存率方面表現出統計學上顯著且具有臨床意義的改善,並且與單獨進行圍手術期化療相比,總體生存率呈現強勁趨勢。

  • MATTERHORN is the third successful perioperative trial for Imfinzi following on from AEGEAN and NIAGARA and it underscores the value of this approach to treatment. This trial represents another blockbuster opportunity, expanding our presence in GI cancers and unlocking further potential for Imfinzi.

    MATTERHORN 是繼 AEGEAN 和 NIAGARA 之後 Imfinzi 第三次成功的圍手術期試驗,它強調了這種治療方法的價值。這次試驗代表著另一個重磅機遇,擴大了我們在胃腸道癌症領域的影響力,並釋放了 Imfinzi 的更多潛力。

  • The practice-changing data from SERENA-6 and MATTERHORN will both feature as ASCO Canary this year, making this the seventh year in a row AstraZeneca data has been included in the plenary sessions at ASCO.

    SERENA-6 和 MATTERHORN 的改變實踐的數據今年都將成為 ASCO Canary,這使得阿斯特捷利康的數據連續第七年被納入 ASCO 的全體會議。

  • Finally, just over a week ago, we were also excited to share the high-level results from the interim analysis of DESTINY-Breast09. This trial demonstrated the combination of Enhertu and pertuzumab resulted in a highly statistically significant and clinically meaningful improvement in progression-free survival versus standard of care 3-drug regimen, THP.

    最後,就在一周多前,我們也很高興分享 DESTINY-Breast09 中期分析的進階結果。該試驗表明,與標準 3 種藥物治療方案 THP 相比,Enhertu 和 pertuzumab 的組合在無惡化存活期方面具有高度統計意義和臨床意義的改善。

  • There were no new safety signals for the combination. And whilst not mature, Enhertu plus pertuzumab demonstrated an early trend to overall survival benefit. DESTINY-Breast09 is the only ongoing first-line trial in HER2-positive metastatic breast cancer population in which investigational therapy is initiated upfront at the onset of treatment and moves Enhertu align earlier in a broad HER2-positive population, with the opportunity to once again redefine management of this disease.

    該組合沒有新的安全訊號。儘管尚未成熟,但 Enhertu 合併帕妥珠單抗已顯示出整體存活獲益的早期趨勢。DESTINY-Breast09 是 HER2 陽性轉移性乳癌族群中唯一正在進行的一線試驗,其中研究治療在治療開始時就啟動,並使 Enhertu 在廣泛的 HER2 陽性人群中更早地對齊,有機會再次重新定義這種疾病的管理。

  • We continue to follow up in both the combination and monotherapy arms. In addition, we're delighted to share that our TROP2-NMR companion diagnostic codeveloped with Roche Tissue Diagnostics has now been granted breakthrough designation by the FDA for use in the TROPION-Lung17 trial which will investigate Datroway in the second-line TROP2-NMR-positive patient population. This underscores the potential of this practice-changing technology, both for Datroway and the broader AstraZeneca portfolio.

    我們將繼續追蹤聯合治療和單一治療組的治療情況。此外,我們很高興地告訴大家,我們與羅氏組織診斷公司共同開發的 TROP2-NMR 伴隨診斷現已獲得 FDA 的突破性認證,可用於 TROPION-Lung17 試驗,該試驗將在二線 TROP2-NMR 陽性患者群體中研究 Datroway 的效果。這凸顯了這項改變實踐的技術對 Datroway 和更廣泛的阿斯特捷利康產品組合的潛力。

  • Next slide, please. We continue to progress our transformative technologies with the potential to disrupt treatment paradigms and deliver sustainable growth beyond 2030. At the Society of Gynecologic Oncology Annual Meeting this year, we shared Phase I/II data for puxitatug samrotecan, also known as PSAN, in endometrial cancer. These data demonstrated an encouraging durable update of response rate of 35% to 38% and a promising median progression fee survival of seven months in the B7-H4 IHC-positive population, alongside a manageable safety profile.

    請看下一張投影片。我們將繼續推動變革性技術,以期顛覆治療模式並在 2030 年後實現永續成長。在今年的婦科腫瘤學會年會上,我們分享了普昔托克(puxitatug samrotecan,也稱為PSAN)治療子宮內膜癌的I/II期數據。這些數據表明,在 B7-H4 IHC 陽性人群中,反應率的持久更新令人鼓舞,為 35% 至 38%,中位進展費用生存期為七個月,同時具有可控的安全性。

  • These data provide us with additional confidence in PSAN and support our decision to start the Phase III trial in endometrial cancer later this year. PSAN is one of our six AstraZeneca ODCs, all of which continue to progress at pace in the clinic. And with that, please advance to the next slide, and I'll pass over to Ruud to cover biopharmaceuticals performance.

    這些數據使我們對 PSAN 更有信心,並支持我們在今年稍後啟動子宮內膜癌 III 期試驗的決定。PSAN 是我們六個阿斯特捷利康 ODC 之一,所有 ODC 均在臨床中持續快速進展。接下來,請進入下一張投影片,我將交給 Ruud 來介紹生物製藥的表現。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Thank you so much, Susan. Please move to the next slide. Our Biopharmaceuticals medicines delivered a strong start to 2025 with total revenue reaching $5.6 billion in the first quarter, reflecting a growth of 12% compared to the first quarter of 2024.

    非常感謝,蘇珊。請移至下一張投影片。我們的生物製藥產品在 2025 年取得了強勁開局,第一季總收入達到 56 億美元,與 2024 年第一季相比成長了 12%。

  • Farxiga revenues exceeded $2 billion for the first time driven by continued demand across chronic kidney disease and heart failure. The strong foundation we have built with Farxiga will support the potential launch of three fixed dose dapagliflozin combinations already in Phase III development. Total revenue in the United States was down 90% versus last year, when revenues benefited from the launch of an generic and the stocking impact is brought with it.

    受慢性腎臟病和心臟衰竭持續需求的推動,Farxiga 的收入首次超過 20 億美元。我們透過 Farxiga 建立的堅實基礎將支持已處於 III 期開發的三種固定劑量達格列淨組合的潛在上市。美國的總收入與去年相比下降了 90%,當時的收入受益於仿製藥的推出以及隨之而來的庫存影響。

  • In China, we anticipate that Farxiga, along with roxadustat, will be included in the VBP program from the middle of the year. We're also expecting to see general competition for Brilinta enter the US market in the coming months. Even so, we expect that the growth drivers in our biopharmaceutical's portfolio this year will clearly outpace the headwinds. Lokelma remains the market leader in an expanding potassium binder class, delivering $153 million in the first quarter and growth of over 35% for the fourth consecutive quarter.

    在中國,我們預計 Farxiga 和 roxadustat 將從今年年中開始納入 VBP 計畫。我們也預期未來幾個月內 Brilinta 的競爭對手將進入美國市場。即便如此,我們預計今年我們生物製藥投資組合的成長動力將明顯超過逆風。Lokelma 在不斷擴大的鉀黏合劑領域仍然是市場領導者,第一季的銷售額達到 1.53 億美元,連續第四個季度成長率超過 35%。

  • R&I delivered another strong quarter, up 13% to $2.1 billion in revenue. Fasenra, Tezspire, Saphnelo, Breztri and now make up just over half of our R&I total revenue, and their combined revenue contribution grew by 40% in the first quarter.

    R&I 又一個季度表現強勁,營收成長 13%,達到 21 億美元。Fasenra、Tezspire、Saphnelo、Breztri 等目前占我們研發總收入的一半以上,它們在第一季的總收入貢獻增加了 40%。

  • Fasenra and Tezspire, both benefited from their strong positions within the fast-growing market for respiratory biologics. Fasenra increased its IL5 class leadership for severe eosinophilic asthma patients supported by the recent launch in GPA, despite achieved leading brand share in key markets with strong launches across Europe.

    Fasenra 和 Tezspire 都受益於其在快速成長的呼吸生物製劑市場中的強勢地位。儘管 Fasenra 憑藉其在歐洲各地的強勁上市在主要市場取得了領先的品牌份額,但其在 GPA 地區新上市的產品仍鞏固了其在治療重度嗜酸性哮喘患者的 IL5 類藥物領域的領先地位。

  • Our order inhaled medicine Pulmicort saw a drop of 26%. The decline was driven by China, due predominantly to a milder winter and continued generic competition.

    我們訂購的吸入藥物 Pulmicort 下降了 26%。銷售量下降的主要原因是中國,主要是因為冬季氣候暖化以及仿製藥競爭持續。

  • In V&I, Beyfortus revenues more than doubled, supported by the recent expansion of manufacturing capacity. This year, we are looking forward to several important readouts for biopharmaceutical medicines. Breztri in asthma, Fasenra in COPD and Saphnelo's subcutaneous formulation. We have completed regulatory submissions in all major markets for Tezspire in nasal polyps. We will also have our first Phase III readout for a new molecular entity with the potential to deliver over $5 billion in peak year revenue.

    在 V&I 領域,由於近期製造能力的擴張,Beyfortus 的營收成長了一倍以上。今年,我們期待生物製藥領域的幾份重要數據。Breztri 用於治療氣喘,Fasenra 用於治療慢性阻塞性肺病,Saphnelo 則使用皮下製劑。我們已經在所有主要市場完成了針對鼻息肉治療藥物 Tezspire 的監管提交。我們還將對一種新的分子實體進行首次 III 期讀數,該實體有可能在高峰年帶來超過 50 億美元的收入。

  • With that, I will now hand over to Sharon to share updates across our biopharmaceutical pipeline in the quarter.

    現在,我將把時間交給 Sharon,讓她分享本季我們生物製藥管道的最新進展。

  • Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Thank you, Ruud. I would like to take a moment to highlight our progress this quarter within the biopharmaceuticals pipeline. At the American College of Cardiology, we were excited to present the positive Phase IIb data for our novel oral small molecule PCSK9 inhibitor, AZD0780, demonstrating a significant LDL cholesterol reduction on top of standard of care and the potential best-in-class profile in patients with hypercholesterolemia.

    謝謝你,魯德。我想花點時間強調我們本季在生物製藥領域的進展。在美國心臟學會,我們很高興地展示了我們的新型口服小分子 PCSK9 抑制劑 AZD0780 的積極 IIb 期數據,證明其在標準治療的基礎上顯著降低 LDL 膽固醇,並可能成為高膽固醇血症患者的最佳治療方案。

  • The data from PURSUIT which were also simultaneously published in the Journal of the American College of Cardiology, found AZD0780 resulted in a 50.7% reduction in LDL-C versus placebo windowed once daily on top of standard-of-care statins.

    PURSUIT 的數據也同時發表在《美國心臟病學會雜誌》上,發現 AZD0780 與每天一次在標準他汀類藥物基礎上服用安慰劑相比,可使 LDL-C 降低 50.7%。

  • Similar efficacy was observed regardless of whether patients received moderate- or high-intensity statin doses at baseline and AZD0780 was well tolerated with a similar frequency of adverse events compared to placebo, consistent with the Phase I data we shared last year.

    無論患者在基線時接受中強度或高強度的他汀類藥物劑量,都觀察到了相似的療效,並且 AZD0780 的耐受性良好,不良事件發生頻率與安慰劑相似,這與我們去年分享的第一階段數據一致。

  • Importantly, as an oral small molecule, ACD0780 offers the advantage of favorable once-daily dosing with no food effect or need for fasting requirements. This convenient profile could enhance patient compliance and has the potential to expand access to this class of medicines beyond its reach today. Dyslipidemia remains a substantial public health concern, placing patients at risk of severe cardiovascular outcomes, including stroke and death and results in approximately 4.4 million deaths per year.

    重要的是,作為一種口服小分子,ACD0780 具有每日一次給藥的優勢,不受食物影響,也不需要禁食。這種便捷的方式可以提高患者的依從性,並有可能擴大此類藥物的可近性。血脂異常仍然是一個重大的公共衛生問題,使患者面臨嚴重心血管疾病的風險,包括中風和死亡,每年導致約 440 萬人死亡。

  • Based on the data from PURSUIT, we are progressing AZD0780 into Phase III at pace, and we will simultaneously initiate 3 pivotal Phase III trials in the coming months. The first will investigate LDL-C reduction; the second will focus on heterozygous familial hypercholesterolemia; and the third is a cardiovascular outcomes trial.

    基於PURSUIT的數據,我們正在快速推進AZD0780進入III期,並將在未來幾個月內同時啟動3個關鍵的III期試驗。第一項研究將研究降低 LDL-C;第二部分將重點放在雜合子家族性高膽固醇血症;第三個是心血管結果試驗。

  • The outcome study will target the prevention of cardiovascular events in patients with a history of atherosclerotic cardiovascular disease and those at high risk of experiencing an ASCVD event. We look forward to updating on future opportunities to use AZD0780 in combination with statins and other small molecules in our broad CVRM portfolio.

    研究結果將針對有動脈粥狀硬化性心血管疾病病史的患者和患有 ASCVD 事件高風險患者的心血管事件預防。我們期待未來有機會在我們廣泛的 CVRM 產品組合中將 AZD0780 與他汀類藥物和其他小分子結合使用。

  • We believe that AZD0780 has the potential to be a $5 billion-plus asset and an important option for patients who urgently need novel approaches to improve their outcomes.

    我們相信 AZD0780 有潛力成為價值 50 億美元以上的資產,對於迫切需要新方法來改善治療結果的患者來說也是一個重要的選擇。

  • And with that, please go to the next slide, and I'll pass over to Marc to cover rare disease.

    接下來,請翻到下一張投影片,我會把主題交給馬克,讓他介紹罕見疾病。

  • Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

    Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

  • Thank you, Sharon. Can I have the next slide. Rare Disease delivered total revenues of $2 billion in quarter one and reflecting stable performance year-on-year. While patient numbers continue to grow across medicine and indication year on year, there are several factors impacting revenue growth in the first quarter.

    謝謝你,莎倫。我可以看下一張投影片嗎?罕見疾病業務第一季總營收達 20 億美元,較去年同期表現穩定。儘管各藥品和適應症的患者數量逐年增長,但仍有幾個因素影響著第一季的收入成長。

  • Ultomiris grew 25%, driven by patient demand across indications, partially offset by competition in general and paroxysmal nocturnal hemoglobinuria and to a lesser extent, from Part D redesign in neurology indications. We expect Soliris revenues to continue to decline due to a successful conversion to Ultomiris, which has launched in all 4 shared indications as well as biosimilar pressure in Europe and unfavorable order timing in certain tender markets.

    Ultomiris 成長了 25%,這得益於患者對各種適應症的需求,但部分抵消了全身性和陣發性睡眠性血紅蛋白尿症領域的競爭,以及在較小程度上抵消了 D 部分對神經病學適應症的重新設計。我們預計 Soliris 的收入將繼續下降,原因是成功轉換為 Ultomiris(已在所有 4 種共享適應症中推出),以及歐洲的生物仿製藥壓力和某些招標市場的不利訂單時機。

  • As a reminder, biosimilars for Soliris have now launched in the United States for PNH, atypical HUS and myosthenia gravis. Beyond complement, Strensiq grew 14%, driven by continued patient demand, moderately offset by some impact from Part D redesign. Koselugo grew 8%, driven by patient demand, partially offset by unfavorable order timing in tender markets. Despite these headwinds, we continue to expect growth across the rare disease portfolio in 2025, but at a slower pace than was seen in 2024.

    提醒一下,Soliris 的生物相似藥現已在美國上市,用於治療 PNH、非典型 HUS 和重症肌無力。除了補充藥物之外,Strensiq 還成長了 14%,這得益於持續的患者需求,但 D 部分重新設計的部分影響在一定程度上抵消了這一增長。受患者需求推動,Koselugo 的銷售額成長了 8%,但招標市場不利的訂單時機部分抵消了這一增長。儘管有這些不利因素,我們仍預期 2025 年罕見疾病產品組合將實現成長,但成長速度將低於 2024 年。

  • During the quarter, Beyonttra1, formerly acoramidis, was approved in Japan for the treatment of adult with amyloid cardiomyopathy. This is an exciting step forward in our progress to deliver an industry-leading portfolio.

    本季度,Beyonttra1(以前稱為 acoramidis)在日本獲得批准,用於治療成人澱粉樣心肌病變。這是我們在提供行業領先產品組合方面邁出的令人興奮的一步。

  • Please advance to the next slide. During the quarter, we received positive news from pediatric study of Ultomiris in HSCT-TMA. HSCT-TMA is a rare type of thrombotic a severe complication of hematopoietic stem cell or bone marrow transplant and is associated with significant morbidity and mortality.

    請前進到下一張幻燈片。本季度,我們從 Ultomiris 在 HSCT-TMA 中的兒科研究中獲得了積極的消息。HSCT-TMA 是一種罕見的血栓性併發症,是造血幹細胞或骨髓移植的嚴重併發症,與嚴重的發病率和死亡率有關。

  • In the Phase III study in pediatric patients, Ultomiris demonstrated improvements in the individual components of TMA response such as platelets, LDH, urinary protein creatinine ratio as well as overall survival. We wait high-level results from the placebo-controlled Phase III trial in adult and adolescent in the second half of the year and look forward to sharing data with regulatory authorities.

    在針對兒科患者的 III 期研究中,Ultomiris 顯示出 TMA 反應的各個組成部分(如血小板、LDH、尿蛋白肌酸酐比率)以及整體存活率的改善。我們等待下半年針對成人和青少年的安慰劑對照 III 期試驗的高水準結果,並期待與監管機構分享數據。

  • This is the first indication expansion opportunity for Ultomiris beyond the Soliris level, representing a potential blockbuster opportunity on a risk-adjusted basis. As outlined on our Investor Day last year, we continued to build out our rare renal pipeline, expanding into post-transplant diseases.

    這是 Ultomiris 首次在 Soliris 水平之外獲得適應症擴展的機會,代表著風險調整後的潛在重磅藥物機會。正如去年投資者日所概述的那樣,我們繼續建立我們的罕見腎臟治療產品線,並擴展到移植後疾病領域。

  • We are initiating the Phase III trial of Ultomiris in delayed graft function, or DGF. With Ultomiris immediate, sustained terminal complement inhibition, we believe it is uniquely positioned to help reduce inflammation in renal injury, ultimately extending kidney transplant organ longevity.

    我們正在啟動 Ultomiris 治療移植功能延遲(DGF)的 III 期試驗。我們相信,憑藉 Ultomiris 即時、持續的終末補體抑制功能,它具有獨特的優勢,有助於減少腎臟損傷中的炎症,最終延長腎臟移植器官的壽命。

  • In the quarter, we also announced our Phase III CALYPSO trial, in chronic patients which met the composite endpoint, showing a statistically significant normalization of serum calcium whilst simultaneously reducing dependence on daily calcium and vitamin D supplements. We have made changes to the trial protocol to allow patients to receive a higher dose based on patient response and additional efficacy analysis will be measured at 52 weeks.

    本季度,我們也宣布了針對慢性病患者的 III 期 CALYPSO 試驗,該試驗達到了綜合終點,結果顯示血清鈣在統計學上顯著恢復正常,同時減少了對每日鈣和維生素 D 補充劑的依賴。我們對試驗方案進行了修改,讓患者可以根據反應接受更高的劑量,並將在 52 週時進行額外的療效分析。

  • This will help to further characterize risk benefit profile. 2025 is a catalyst rich year for rare disease portfolio with four Phase III trials due to readout, three of which are NME opportunities.

    這將有助於進一步描述風險收益狀況。 2025 年是罕見疾病組合催化劑豐富的一年,有四項 III 期試驗即將公佈,其中三項是 NME 機會。

  • And with that, please advance to the next slide, and I will hand back to Pascal.

    接下來,請進入下一張投影片,我將把發言權交還給 Pascal。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc. Next slide, please. We've made a strong start to the year with several important readouts already in hand. But this is only the beginning. As you can see on this slide, the number of high-value upcoming catalysts we have through the end of 2025 is quite remarkable. And together, they represent over $10 billion in potential peak risk-adjusted -- potential risk-adjusted peak year revenue, sorry.

    謝謝你,馬克。請看下一張投影片。我們今年已經有了一個好的開端,已經掌握了幾份重要的數據。但這只是個開始。正如您在這張投影片上看到的,到 2025 年底,我們擁有的高價值新興催化劑的數量相當驚人。總的來說,它們代表著超過 100 億美元的潛在高峰風險調整——潛在風險調整後的高峰年收入,抱歉。

  • Next slide, please. In closing, already this year, we are tracking well towards our 2030 ambition. We expect continued growth from all of our therapy areas over the balance of the year and across key geographies. Importantly, global demand for our medicines is expected to offset the known headwinds.

    請看下一張投影片。最後,今年我們已經在順利達成 2030 年目標。我們預計,今年餘下時間裡,我們所有的治療領域以及主要地區都將持續成長。重要的是,全球對我們藥品的需求預計將抵消已知的阻力。

  • As evident from our results in these and prior quarters, we remain focused on delivering operating leverage while continuing to invest in our pipeline and in transformative technologies to support our growth to 2030 and beyond. And lastly, we are on track to deliver at least 20 new medicines by 2030 with 9 delivered already, an accelerating pace of new approvals is anticipated across our portfolio.

    從本季和前幾季的業績可以看出,我們仍然專注於提供經營槓桿,同時繼續投資於我們的產品線和變革性技術,以支持我們到 2030 年及以後的成長。最後,我們預計在 2030 年前推出至少 20 種新藥,目前已推出 9 種,預計我們的整個產品組合的新藥審批速度將加快。

  • Please advance to the next slide and we will move to the Q&A.

    請進入下一張投影片,我們將進入問答環節。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • (Event Instructions) Sarita Kapila, Morgan Stanley.

    (活動說明) 摩根士丹利的 Sarita Kapila。

  • Sarita Kapila - Analyst

    Sarita Kapila - Analyst

  • It's Sarita at Morgan Stanley. So firstly, how should we think about the impact of the Medicare Part D redesign in the US as we move through the year? Was it mostly Q1 weighted or do you expect further impact from here? And if you could help frame or quantify the overall impact for the full year and comment on the underlying outlook for '25 in oncology, that would also be useful?

    我是摩根士丹利的薩麗塔。那麼首先,我們應該如何看待美國醫療保險 D 部分重新設計在今年帶來的影響?它主要對第一季產生影響嗎?還是您預計它會產生進一步的影響?如果您能幫助建立或量化全年的整體影響並對 25 年腫瘤學的基本前景進行評論,那也會有幫助嗎?

  • And then just a quick one on perhaps you could talk about the confidence around the QCS biomarker? And if there are any examples about a retro biomarker -- a retrospective, sorry, biomarker translating to the prospective setting? And talk about the rationale for using Imfinzi as the backbone versus KEYTRUDA peers? And does that increase the risk of the trial?

    然後您能否簡單談談對 QCS 生物標記的信心?是否有關於回顧性生物標記的例子 - 抱歉,回顧性生物標記轉化為前瞻性設定?並談談使用 Imfinzi 作為骨幹藥物而非 KEYTRUDA 作為同類藥物的理由?這是否會增加審判的風險?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Sarita. Maybe, Dave, you could take the first question and Susan, the second one.

    謝謝,薩麗塔。也許,戴夫,你可以回答第一個問題,蘇珊,你可以回答第二個問題。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Absolutely. Sarita, thanks for the question. In terms of your specific question, I would think of Part D as a rebasing that happens at the beginning of this year and then all volume growth that we're able to have from here is going to be against that rebased number.

    絕對地。薩麗塔,謝謝你的提問。就您的具體問題而言,我認為 D 部分是今年年初發生的重新調整,然後我們從現在能夠獲得的所有交易量增長都將與該重新調整的數字相符。

  • And the reason for that is that catastrophic is triggered on the very first fill within our oral oncology products. So it will not grow from here. It's a rebased number from here. Obviously, it grows as our volumes grow within Part D. But I think to put this into some context and maybe I'll just talk specifically about Tagrisso because I think it's a good example.

    原因在於,我們的口腔腫瘤產品第一次填充時就引發了災難性的後果。所以它不會從這裡生長。這是從這裡重新調整後的數字。顯然,隨著 D 部分銷量的成長,它也會成長。但我認為,要把這個放在某種背景下,也許我會具體談談 Tagrisso,因為我認為這是一個很好的例子。

  • In the US, we saw a 20% increase in volumes from our ongoing launches of ADORA, LAURA, all going really, really well. together with reduced free good utilization and some price increases that offset the gross to net impact from Part D redesign. So we saw revenue growth of 9% in the US, volume growth of 20%.

    在美國,我們持續推出的 ADORA、LAURA 等產品的銷售量成長了 20%,一切都很順利。加上免費商品利用率的降低和價格的上漲,抵消了 D 部分重新設計對總淨額的影響。因此,我們看到美國的收入成長了 9%,銷量成長了 20%。

  • And I think that importantly, the new patient start and TRx data show that we're also really managing competition well with FLAURA and FLAURA2. And we expect continued revenue growth throughout 2025 within this. So I think full year outlook on our oral oncolytics remains strong. We've got good growth drivers that we're able to operate against. And as long as we continue to navigate against those key performance indicator as well.

    我認為重要的是,新患者開始和 TRx 數據顯示我們也確實很好地管理了與 FLAURA 和 FLAURA2 的競爭。我們預計 2025 年全年營收將持續成長。因此我認為我們的口服溶瘤藥物的全年前景依然強勁。我們擁有良好的成長動力,能夠充分發揮我們的潛力。只要我們繼續按照這些關鍵績效指標前進。

  • I'm confident that we will grow from this rebasing period.

    我相信,我們將從這個重新調整階段中獲得成長。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Dave. Maybe just to add, Sarita, is that they've said a 20% volume growth on Tagrisso, we have more than 20% volume growth on Calquence. And the important piece is that this year, we have this, of course, one-off Part D price resetting, if you want, but the volume growth further supported by new indications for both Calquence and Tagrisso will really support well our growth into '26 and beyond. So I think for those products, we can have a fairly optimistic outlook in the US but also beyond the US. Susan, do you want to take the second question?

    謝謝,戴夫。也許只是補充一下,薩麗塔,他們說 Tagrisso 的銷量成長了 20%,而 Calquence 的銷量成長也超過了 20%。重要的是,今年,如果您願意的話,我們當然可以進行一次性的 D 部分價格重置,但 Calquence 和 Tagrisso 的新適應症進一步支持的銷售增長將真正支持我們在 26 年及以後的增長。因此我認為,對於這些產品,我們不僅在美國,而且在美國以外都擁有相當樂觀的前景。蘇珊,你想回答第二個問題嗎?

  • Susan Galbraith - Executive Vice President - Oncology and Research and Development

    Susan Galbraith - Executive Vice President - Oncology and Research and Development

  • Yes, sure. Thank you. So just as a reminder for AVANZAR, we have taken the learnings that we had from TROPION-Lung01 and made changes to AVANZAR, which should include focusing on the clinically meaningful benefit that we saw in TL01 in the non-squamous patient population and allowed us to enrich for that.

    是的,當然。謝謝。因此,提醒 AVANZAR,我們吸取了從 TROPION-Lung01 中獲得的經驗教訓,並對 AVANZAR 進行了修改,其中應該包括關注我們在非鱗狀患者群體中看到的 TL01 具有臨床意義的益處,並使我們能夠豐富這一點。

  • And then what we also have done is embed the QCS biomarker. So in terms of your question about that, the confidence that we have in QCS is based on our understanding of the mechanism that we have with Datroway, which is dependent not just on the surface expression of TROP2, but the amount that gets internalized and that's embedded into this NMR QCS positivity.

    然後我們也做了嵌入 QCS 生物標記。因此,就您對這個問題的問題而言,我們對 QCS 的信心是基於我們對 Datroway 機制的理解,該機制不僅取決於 TROP2 的表面表達,還取決於內部化的數量以及嵌入到 NMR QCS 陽性中的數量。

  • I also have said that the data that we have seen from the TROPION-Lung01, we have seen similar trends in other data. I'll point out that we have an update on the TROPION-Lung02 data set that will be presented at ASCO, which will include an analysis of the QCS data and of course, that's important because it's in TROPION-Lung02, it's the combination also of Imfinzi and with an IO agent and with the combination with platinum. So I think the confidence is built on seeing the similar effects in multiple data sets and embedded on the mechanism that we understand for why data is active and differentiated.

    我還說過,從 TROPION-Lung01 看到的數據來看,我們在其他數據中也看到了類似的趨勢。我要指出的是,我們對 TROPION-Lung02 數據集進行了更新,該更新將在 ASCO 上展示,其中將包括對 QCS 數據的分析,當然,這很重要,因為它在 TROPION-Lung02 中,它也是 Imfinzi 與 IO 藥劑以及鉑的組合。因此,我認為信心是建立在看到多個資料集中的類似效果以及我們理解資料活躍和差異化的機制之上的。

  • And in terms of Imfinzi activity, I think that the number of positive Imfinzi trials in a number of different settings is further proof of the relevance of that mechanism of action. And again, we have data in TROPION-Lung04 and TROPION-Lung02, which are very consistent across different IO checkpoint inhibitors. So we remain confident in the combinability of data with Imfinzi and the application of that into the important patient population in first-line non-small cell lung cancer.

    就 Imfinzi 活性而言,我認為在許多不同環境中進行的 Imfinzi 陽性試驗的數量進一步證明了該作用機制的相關性。再次強調,我們在 TROPION-Lung04 和 TROPION-Lung02 中擁有數據,它們在不同的 IO 檢查點抑制劑之間非常一致。因此,我們對與 Imfinzi 的數據可結合性以及將其應用於一線非小細胞肺癌的重要患者群體仍然充滿信心。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • James Gordon, JPMorgan.

    摩根大通的詹姆斯戈登。

  • James Gordon - Analyst

    James Gordon - Analyst

  • James Gordon, JPMorgan. First question was on the oral PCSK9. So you had strong Phase II data, and you've announced the Phase III program today and flagged the $5 billion plus sales. But competitor injectable can uptake has been slower than a anticipated. So can you talk about how you're now thinking in terms of how much will expand the market?

    摩根大通的詹姆斯戈登。第一個問題是關於口語 PCSK9 的。因此,您擁有強大的 II 期數據,並且今天宣布了 III 期計劃,並標明銷售額超過 50 億美元。但競爭對手注射罐的吸收速度比預期的慢。那麼,您能談談您現在對市場擴張規模的看法嗎?

  • And how dominant share you think your product would have of the oral opportunity to get to your $5 billion-plus? What are you thinking there? And when this could potentially launch? So you said what the three programs would be, but when could you have the pivotal data? That's the first question, please.

    您認為您的產品在口腔護理市場中佔據多大份額,並能夠幫助公司獲得 50 多億美元的銷售額?你在想什麼?什麼時候可能推出?所以您說了這三個項目是什麼,但是什麼時候可以獲得關鍵數據?這是第一個問題。

  • Second question, US manufacturing. So you source the majority of the US product from the US Are you considering any incremental US manufacturing investments? And could that be accommodated within the existing circa $3 billion of CapEx per year or might you need to step it up or could it be about reallocation?

    第二個問題,美國製造業。所以你們從美國採購大部分美國產品,你們是否考慮對美國製造業進行增量投資?這是否可以在現有的每年約 30 億美元的資本支出內實現,或者是否需要加大投入,或者是否需要重新分配?

  • And then if I could just find a clarification on IRA and Part D redesign. So should we assume you already had the full pricing mix hit in Q1, but we could see further volume expansion due to greater affordability through the year so you could actually see revenues accelerate for some of these impacted products through the year or is it more like the absolute Q1 performance is the new run rate. So you've got the pricing mix already and you've had the volume uplift already. So do things accelerate further through the year or this is just the new normal already in Q1?

    然後,如果我能找到有關 IRA 和 Part D 重新設計的說明。因此,我們是否應該假設您已經在第一季度獲得了全部定價組合,但由於全年價格承受能力的提高,我們可以看到銷量進一步擴大,因此您實際上可以看到其中一些受影響產品的收入在全年加速增長,或者更像是絕對的第一季表現是新的運行率。因此,您已經獲得了定價組合,並且已經實現了銷售提升。那麼,今年的情況是否會進一步加速,還是這只是第一季的新常態?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, James. So that's not too many questions. Thank you. So the first one is oral, I guess, Ruud do you want to take this one? Aradhana, you could take the second and Dave, back to you for the third one.

    謝謝你,詹姆斯。所以問題不多。謝謝。所以第一個是口頭的,我猜,魯德你想參加這個嗎?Aradhana,你可以拿第二個,然後 Dave,拿第三個。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yes. First of all, James, we need to realize that 70% of the patient population eligible for cholesterol-lowering drugs are not at goal. So we firmly believe that a product like an oral PCSK9 will substantially unlock the opportunity in order to serve a very large population across the world. The second part is that we all know that the injectables we're facing quite a bit of an issue from an access perspective and our PCSK9 probably will be priced at a lower level and hence, also in the emerging markets where we have a very strong footprint, I think the oral PCSK9 will fulfill a huge medical need.

    是的。首先,詹姆斯,我們需要認識到,70% 符合降膽固醇藥物治療條件的患者並未達到目標。因此,我們堅信,像口服 PCSK9 這樣的產品將大大釋放機會,為全世界的廣大民眾提供服務。第二部分是,我們都知道,從獲取角度來看,注射劑面臨著相當大的問題,而我們的 PCSK9 的價格可能會較低,因此,即使在我們擁有強大影響力的新興市場,我認為口服 PCSK9 也將滿足巨大的醫療需求。

  • And last but not least, I think the uniqueness of our oral PCSK9 is it's a true small molecule. And I think Sharon articulated it very well. So we are also looking for, let's say, combinations of our all PCSK9s, for example, with our own Crestor or ezetimibe, and that makes, I think, the proposition a potentially very big one.

    最後但同樣重要的一點是,我認為我們的口服 PCSK9 的獨特之處在於它是一種真正的小分子。我認為莎倫表達得非常好。因此,我們也在尋找,比如說,我們所有的 PCSK9 與我們自己的 Crestor 或依折麥布的組合,我認為,這使得這個提議具有很大的潛力。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • So, James, on -- in terms of your question on CapEx and tariff related and what incremental investments that may be required. So two different things, one is as it relates to some of the minority of the products that we do import from Europe into the US. We're already starting to take action as it relates to tech transfers and building some of the capacity there. But also note that we do have always a dual-source supply and so forth and also capacity within our existing facilities. So the incremental investment required for that to happen will be manageable.

    那麼,詹姆斯,關於你關於資本支出和關稅相關的問題以及可能需要哪些增量投資。所以有兩件不同的事情,一是跟我們從歐洲進口到美國的一些少數產品有關。我們已經開始採取行動,涉及技術轉移和部分產能建設。但也請注意,我們確實始終擁有雙源供應等等,現有設施內也具備產能。因此,實現這一目標所需的增量投資將是可控的。

  • In terms of the overall CapEx, so last year, as you know, we also announced a $3.5 billion CapEx and investment in the US We've said this year that our CapEx would be 50% higher than last year. But going forward, we need to look at how the portfolio develops. So for example, if the oral GLP-1 is successful in Phase II as the PCSK9 progresses as progress as reads out, we will then start to plan for success these molecules, and we'll build and manage supply accordingly. Dave?

    就整體資本支出而言,如你所知,去年我們也宣布了 35 億美元的資本支出和在美國的投資。我們今年表示,我們的資本支出將比去年高出 50%。但展望未來,我們需要看看投資組合如何發展。例如,如果口服 GLP-1 在第二階段取得成功,而 PCSK9 也取得進展,那麼我們將開始規劃這些分子的成功,並相應地建立和管理供應。戴夫?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • James, on your clarification question. So let me break down into the components. The first part is that at the beginning of the plan year, as we move from a co-pay cap of 3,300 to 2,000, we saw an increase in the number of patients or reduced number of patients in free drug program, an increase in the number of patients that came off a free drug and into the commercial program.

    詹姆斯,關於你的澄清問題。那麼讓我來將其分解成各個部分。第一部分是,在計劃年度開始時,隨著我們的共同支付上限從 3,300 增加到 2,000,我們看到免費藥物計劃中的患者數量有所增加或減少,而從免費藥物轉入商業計劃的患者數量有所增加。

  • I think that is a onetime effect that you won't see the volume grow over the course of the year. However, the reduced abandonment rate, I do think grows over the year. And very much the revenue growth and the volume growth that we're seeing from FLAURA2, ADAURA, LAURA on Tagrisso is growth that we'll continue to see moving forward from this new rebased level that we're at in terms of where the Part D impact came from reform.

    我認為這只是一次性的影響,你不會看到交易量在一年內成長。然而,我認為放棄率的降低確實會逐年增加。我們從 FLAURA2、ADAURA 和 Tagrisso 上的 LAURA 所看到的收入增長和銷售增長,是我們將繼續看到的從我們現在所處的新的重新調整的水平向前發展的增長,就 D 部分改革的影響而言。

  • I would also note that there is one other dimension on Calquence, and we've spoken about this or I spoke about it last quarter. There are some contracting decisions that we took to secure preferred formulary access. Those are onetime impacts in terms of -- to gross to net that we probably will see in the quarter, and we'll grow volume against that as we pull through those contracts and get opportunity to really make sure that, that preferred access is translating into continued leadership in CLO.

    我還要指出的是,Calquence 還有另一個維度,我們已經討論過這個問題,或者我上個季度討論過這個問題。我們做出了一些簽約決定以確保優先獲得處方集。這些都是一次性的影響——從總額到淨額,我們可能會在本季度看到,隨著我們完成這些合約並獲得機會真正確保優先訪問權限轉化為 CLO 的持續領導地位,我們將增加交易量。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you. Dave. James, maybe if I can come back very briefly to the -- your first question, oral PCSK9. I think it's important to keep in mind, you have 24 million people -- patients, people in the US who have cardiovascular disease.

    謝謝。戴夫。詹姆斯,也許我可以非常簡短地回答一下你的第一個問題,口服 PCSK9。我認為重要的是要記住,美國有 2400 萬人患有心血管疾病。

  • 70% of them are not a target. They have a cholesterol level above 70. So it's a huge number of people who have established cardiovascular disease are not a target.

    其中70%都不是目標。他們的膽固醇水平超過70。因此,大量患有心血管疾病的人並不屬於治療目標。

  • And then I'm not even speaking about the population that has elevated cholesterol above 100 in a general population and are not treated. So potential for an agent that is priced at the right level, as Ruud explained, is really very, very large. So if our studies deliver, of course, we have to have good results, but we have good reasons to believe the product will deliver the opportunity to help patients and grow the product is quite enormous in the US but also beyond.

    我甚至還沒有談到普通人群中膽固醇升高超過 100 且未接受治療的人群。因此,正如魯德所解釋的那樣,對於一個定價合適的經紀人來說,其潛力確實非常非常大。因此,如果我們的研究取得成功,我們當然必須取得良好的結果,但我們有充分的理由相信該產品將為幫助患者帶來機會,並且該產品在美國乃至更廣闊的範圍內都將獲得巨大的發展。

  • Remember, Injectable PCSK9 are great products, but in Europe, they are very limited in terms of access because, of course, mostly. So again, if we bring a product that is more affordable. The potential there is quite enormous.

    請記住,注射用 PCSK9 是很好的產品,但在歐洲,它們的獲取管道非常有限,當然,主要是因為。所以,如果我們再推出一款更實惠的產品。那裡的潛力相當巨大。

  • Rajan Sharma, Goldman Sachs.

    高盛的拉詹·夏爾馬。

  • Rajan Sharma - Analyst

    Rajan Sharma - Analyst

  • Hi, sorry, hopefully, you can hear me now. I forgot to unmute. So, thanks for taking my questions. Firstly, on DB09, could you just talk to the potential filing strategy there? Do you think you'll file the combination on before the monotherapy data are available?

    嗨,很抱歉,希望你現在能聽到我說話。我忘了取消靜音。感謝您回答我的問題。首先,關於 DB09,您能談談那裡的潛在歸檔策略嗎?您認為您會在單一療法數據公佈之前提交組合療法申請嗎?

  • And then secondly, just on a follow-up at a comment Susan made on ASCO data. And just to clarify, will that be QCS biomarker analysis of OS from TROPION-Lung01 that's available at ASCO?

    其次,讓我們來跟進一下 Susan 對 ASCO 資料所作的評論。需要澄清的是,ASCO 提供的 TROPION-Lung01 OS 的 QCS 生物標記分析是否有效?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Rajan. For you, Susan.

    謝謝,拉詹。給你,蘇珊。

  • Susan Galbraith - Executive Vice President - Oncology and Research and Development

    Susan Galbraith - Executive Vice President - Oncology and Research and Development

  • Okay. And so just for the second one, just to clarify, what I was talking about we're going to present within the TROPION-Lung02 data set biomarker day looking at the QCS biomarker within that study, which I think will be helpful in addition to the data that we had from TROPION-Lung01.

    好的。因此,對於第二個問題,為了澄清起見,我剛才說的是,我們將在 TROPION-Lung02 數據集生物標記日中展示該研究中的 QCS 生物標誌物,我認為這將對我們從 TROPION-Lung01 獲得的數據有所幫助。

  • And in terms of DESTINY-Breast09, obviously, we're in discussions with regulatory authorities. As we said, I think the data show a highly clinically meaningful results, and I think that will influence regulators, but those discussions are ongoing. And we also, I would just say, optimistic in terms of the potential for presentation of DESTINY-Breast09 at ASCO.

    就 DESTINY-Breast09 而言,顯然我們正在與監管機構進行討論。正如我們所說,我認為數據顯示了具有高度臨床意義的結果,我認為這會影響監管機構,但這些討論仍在進行中。而且我想說的是,我們對在 ASCO 上展示 DESTINY-Breast09 的潛力持樂觀態度。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Sachin Jain, Bank of America.

    美國銀行的 Sachin Jain。

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • Hi there, two questions, please. So firstly, Pascal, you just high level on US pricing. Any high-level perspectives on Trump executive order, how you're thinking about US pricing has been a lot from yourself and others in the media so wondering if you could just touch on that?

    你好,請問兩個問題。首先,帕斯卡,你對美國的定價水準很高。您對川普行政命令有何高見?您對美國定價的看法如何?您本人和其他媒體人士對此有很多評論,您能否簡單談談這一點?

  • And then secondly, for onc, I guess this is more for Dave, but SERENA-6, congrats on the plenary, I wonder if you could just reappraise us how you're thinking about the commercial opportunity relative to the $5 billion you framed for the molecule as a whole. Obviously, seeing the majority is in. But if you could just comment to how you're thinking about sort size and factors that we should be thinking around adoption in terms of testing duration of therapy, et cetera?

    其次,對於 onc,我想這更多是針對 Dave 的,但是 SERENA-6,祝賀全體會議,我想知道您是否可以重新評估一下您如何看待相對於您為整個分子設定的 50 億美元的商業機會。顯然,大多數人都同意。但是,如果您可以評論您如何看待排序大小以及我們在測試治療持續時間等方面應該考慮的因素?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So maybe let me quickly comment on the first question, Sachin. I mean US pricing, of course, lots of potential outcomes here, but it's not very easy to comment because nobody really knows. But it is clear that this is an issue that will be on the radar screen of many people.

    所以也許讓我快速評論一下第一個問題,Sachin。我指的是美國的定價,當然,這裡有很多潛在的結果,但不太容易評論,因為沒有人真正知道。但顯然,這個問題會引起很多人的注意。

  • The reality, I think, is that there has to be a rebalancing. And in fact, the US has been funding innovation for our industry for a long time. And we believe that Europe has to invest a greater share of their health care expenses and that share has been declining steadily over the last number of years down to 7% of health care budget being allocated to innovative medicines in the UK

    我認為,現實情況是必須進行重新平衡。事實上,美國長期以來一直在為我們的行業創新提供資金。我們認為,歐洲必須投入更大比例的醫療保健費用,而這一比例在過去幾年中一直在穩步下降,目前英國分配給創新藥物的醫療保健預算已降至 7%。

  • What can you do it 7% of your health care cost allocated to innovating medicines, of course, not much. So the investment in innovation, in pharmaceuticals in Europe has to go up. And what that means is for some products, higher prices that are closer to higher certainly than they are today, maybe closer to the US, but importantly, also faster access and better access for patients. So at the end of the day, what happens in the US, we'll have to see, of course, there are ongoing discussions, as you can imagine.

    你能做什麼呢?將醫療保健費用的 7% 分配給創新藥物,當然,這並不多。因此,歐洲對創新和製藥的投資必須增加。對於某些產品而言,這意味著價格肯定會比現在更高,可能更接近美國的價格,但重要的是,患者也能更快、更好地獲得藥物。所以最終,我們必須看看美國會發生什麼,當然,正如你所想像的,討論仍在進行中。

  • But I really think the key piece is that Europe, at least richer countries in Europe have to contribute more to pharmaceutical innovation, just like they have to contribute more to their own defense. So it's relocation of GDP, which actually in terms of pharmaceutical innovation would be relatively modest. But that would enable a lot of accelerated access and certainly a pricing level that would enable to rebalance in the funding of that innovation between the US and Europe.

    但我確實認為關鍵在於歐洲,至少是歐洲較富裕的國家必須為醫藥創新做出更多貢獻,就像他們必須為自己的國防做出更多貢獻一樣。因此,這是 GDP 的轉移,實際上就醫藥創新而言,其影響相對較小。但這將實現大量的加速訪問,並且肯定會實現一個定價水平,從而能夠重新平衡美國和歐洲之間對該創新的資助。

  • And second question, Dave, do you want to cover that?

    第二個問題,戴夫,你想談談這個嗎?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Yes. So CAMI, broadly and really talking about the SERENA-6 opportunities. So I mean, as we think about camizestrant, Sachin, obviously, the program comprises early adjuvant breast cancer trials as well as metastatic studies. I think that if we're able to unlock an opportunity within the adjuvant setting and within SERENA-4 to the point that you raised, that really is going to do the lion's share of the work to get us to that $5 billion plus.

    是的。因此,CAMI 廣泛而真實地談論了 SERENA-6 機會。所以我的意思是,當我們考慮卡米司特蘭時,薩欽,顯然,該計劃包括早期輔助乳癌試驗以及轉移性研究。我認為,如果我們能夠在輔助治療領域和 SERENA-4 中抓住機會,達到您提出的那樣,那麼這將為我們實現 50 多億美元的目標做出最大努力。

  • But Serena 6 is such an important study. And the reason it's important is that there's 85,000 patients with frontline drug-treated hormone receptor positive HER2-negative metastatic breast cancer in the G7. And 2/3 of those patients are considered endocrine therapy sensitive and they're treated today with the CDK4/6 and in ET in the frontline setting.

    但 Serena 6 是一項非常重要的研究。它之所以重要是因為七國集團中有 85,000 名接受第一線藥物治療的荷爾蒙受體陽性 HER2 陰性轉移性乳癌患者。其中 2/3 的患者對內分泌治療敏感,目前他們在前線環境中接受 CDK4/6 和 ET 治療。

  • And we know that 30% of those, so this is a very significant number, developed the ESR1 mutation during the course of the frontline treatment. And that ESR1 mutation is something that can be today detected with NGS testing. And NGS, at least in the United States, is fairly common among this population. So there is going to be work that we're going to need to do to incorporate this testing as part of the regular blood work that's being done.

    我們知道其中 30% 的患者在接受第一線治療期間發生了 ESR1 突變,這是一個非常大的數字。如今,ESR1 突變可以透過 NGS 檢測檢測到。至少在美國,NGS 在這群人中相當普遍。因此,我們需要將這項測試納入常規血液檢查的一部分。

  • But the access to the test and the test itself is something that is already incorporated into the workflow and into the practice. And it allows for us to, in addition to moving earlier than the other next generation surge, which gives us an opportunity for early experiences. I think the likelihood that those experiences are going to be good ones is high. And I also think that the fact that we can use this on a backbone of multiple CDK4/6s is also really important. So those are the elements of SERENA-6 that I think are most noteworthy.

    但是,測試的存取和測試本身已經融入工作流程和實踐中。它不僅讓我們比其他下一代浪潮更早行動,也為我們提供了早期體驗的機會。我認為這些經驗很有可能是好的。而且我還認為,我們可以在多個 CDK4/6 的主幹上使用它這一事實也非常重要。這些就是我認為 SERENA-6 最值得注意的元素。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • And maybe to add back again to your earlier question, Sachin. I want to make sure that everybody understands this price difference between the US and Europe is not true for every product. I mean there are lots of products that have a similar net prices. I mean, in Europe, you have a single price.

    也許我可以再次回答你之前的問題,Sachin。我想確保每個人都明白,美國和歐洲之間的價格差異並不適用於所有產品。我的意思是有很多產品的淨價都相似。我的意思是,在歐洲,價格是單一的。

  • In the US, you have commercial, you have Medicare, you have Medicaid. And then in commercial and Part D, we provide large amount of rebates and those rebates can be very, very large for some products. So if you look at things on a net basis, net of rebates, incorporating Medicaid and sort of calculate a net price for the United States that you could compare to the price in Europe.

    在美國,有商業保險、醫療保險和醫療補助。然後在商業和 D 部分,我們提供大量的回扣,對於某些產品來說,這些回扣可能非常非常大。因此,如果您從淨額角度來看待事物,扣除回扣,納入醫療補助,併計算出美國的淨價,您就可以將其與歐洲的價格進行比較。

  • For many medicines, the difference is actually very small and sometimes 0, actually no difference or very little. So really, we're talking about a few products. And as I said, Europe has to fund this innovation in a better way.

    對於許多藥物來說,差異實際上非常小,有時為0,實際上沒有差異或差異很小。所以實際上我們正在談論一些產品。正如我所說,歐洲必須以更好的方式資助這項創新。

  • Steve Scala,Cowen.

    史蒂夫·斯卡拉,考恩。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • I have two questions. Pascal, to sum up your tariff commentary in the prepared remarks, is it fair to say that under all contemplated scenarios and in light of AstraZeneca's actions over the next 2 to 3 years, tariffs are not material at the group level. Is that a fair conclusion?

    我有兩個問題。帕斯卡,總結一下您在準備好的評論中對關稅的評論,是否可以公平地說,在所有考慮的情況下,鑑於阿斯利康在未來 2 到 3 年內的行動,關稅在集團層面並不重要。這是一個公平的結論嗎?

  • And then the second question is for Dave. On DB09, the press release stated that safety was consistent with the known profile Enhertu, but it could be argued that in first-line setting, it needs to be better, especially regarding ILD. So what should be our expectations for the full data set? And will DB09 contribute to sales in 2025?

    第二個問題是問戴夫的。關於 DB09,新聞稿指出其安全性與已知的 Enhertu 概況一致,但可以說,在一線環境中,它需要做得更好,尤其是在 ILD 方面。那麼我們對完整資料集的期望應該是什麼?那麼DB09會對2025年的銷售量做出貢獻嗎?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Steve. So quick -- the first question. I mean I'm not able to forecast every potential scenario. In the world we live in, we have to assure made any scenario is possible, even scenarios, we can't even imagine today. So it's hard to answer your question.

    謝謝,史蒂夫。那麼快——第一個問題。我的意思是我無法預測每一種可能的情況。在我們生活的世界裡,我們必須確保任何情境都是可能的,甚至是我們今天無法想像的情景。所以很難回答你的問題。

  • But what I can say is that, yes, I mean, within a period of time, which may be 2 years, any impact we have would actually be managed. As I said, first of all, the impact is limited, but importantly, the impact we have is time limited because we are redeploy manufacturing instead of globalizing the manufacturing of one product in the US for the world or in Europe for the world, we can actually share and sort of manufacture one product for the US in the US and the rest in Europe and vice versa.

    但我可以說的是,是的,我的意思是,在一段時間內,可能是兩年,我們造成的任何影響實際上都會得到控制。正如我所說,首先,影響是有限的,但重要的是,我們的影響是時間有限的,因為我們正在重新部署製造業,而不是全球化地在美國為世界生產一種產品或在歐洲為世界生產一種產品,我們實際上可以共享並在美國為美國生產一種產品,在歐洲生產其餘產品,反之亦然。

  • So we have -- because of our network, we have the ability to shift manufacturing around, so yes, within a relatively short period of time, I mean, basically, these issues could be managed and are suddenly not material long term as we -- based on what we can see today.

    因此,由於我們的網絡,我們有能力轉移製造業,所以是的,在相對較短的時間內,我的意思是,基本上,這些問題可以得到管理,而且根據我們今天所看到的情況,它們突然不再是長期重要問題。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Steve, on your DB09 question, I mean you'll have to go to the presentation to get into the details on the specific data within it. But I do think that what I would point to is that when we speak to the results being statistically significant and clinically meaningful, that is an overall assessment of the benefit risk.

    史蒂夫,關於您的 DB09 問題,我的意思是您必須去查看演示文稿才能了解其中的具體數據的詳細信息。但我確實認為,我想指出的是,當我們談論結果具有統計意義和臨床意義時,這是對效益風險的整體評估。

  • And I think that the trend in overall survival that we commented to is also something that underscores the entire benefit risk within that population is a very important study, 25,000 G7 frontline drug-treated HER2-positive patients. This is a study in a broad population.

    我認為,我們評論的整體存活趨勢也強調了該族群的整體利益風險,這是一項非常重要的研究,研究對象為 25,000 名接受 G7 一線藥物治療的 HER2 陽性患者。這是一項針對廣泛人群的研究。

  • And on your question on use in 2025. Obviously, we won't promote to anything before it's approved. We certainly do know that guidelines and presentations can result in markets, particularly in the US, where it's allowed for spontaneous use, but we'll have to see what the reaction is to the data after it's presented.

    關於您關於 2025 年使用情況的問題。顯然,在獲得批准之前我們不會推廣任何東西。我們確實知道指導方針和演示可以影響市場,特別是在美國,在那裡允許自發性使用,但我們必須看看在數據呈現之後市場的反應。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Mattias Häggblom, Handelsbanken.

    Mattias Häggblom,德國商業銀行。

  • Mattias Häggblom - Analyst

    Mattias Häggblom - Analyst

  • Two much questions, please. Firstly, for Pascal on tariffs and drug pricing, but perhaps a different angle. Over the last couple of years, a handful of members, including AstraZeneca has left different industry associations like in recent weeks, we've seen a number of individual pharma executives share that perspective on the best path forward.

    請問有兩個問題。首先,對帕斯卡來說,關於關稅和藥品定價,也許角度不同。在過去的幾年裡,包括阿斯特捷利康在內的少數成員離開了不同的行業協會,就像最近幾週一樣,我們看到許多製藥公司的高階主管就最佳前進道路分享了這種觀點。

  • My question goes to what extent do you anticipate the industry to come together more in the near future in order to perhaps better leverage its message to different stakeholders and up the odds of a favorable path forward for the industry?

    我的問題是,您預計該行業在不久的將來會在多大程度上更加團結,以便更好地向不同的利益相關者傳達信息,並提高該行業向前發展的有利道路的可能性?

  • And then secondly, for Aradhana. It's now almost a year since the company shared its $80 billion revenue target for 2030, an ambition sometimes described as conservative within the investment community. From your perspective, any particular areas you'd like to point as to what the company's internal modeling still deviates materially from company compiled consensus?

    其次,對 Aradhana 來說。距離該公司公佈其 2030 年 800 億美元的營收目標已過去近一年時間,投資界有時將這一目標描述為保守的。從您的角度來看,您想指出哪些特定領域,即公司的內部模型仍然與公司編制的共識有重大偏差?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • It's interesting to hear the $80 billion is conservative, it's first time I hear it as he described. It's conservative Mattias, but it's still it's still nice to hear that you believe in our portfolio. So I'll leave that answer to Aradhana.

    有趣的是,800億美元是保守的數字,這是我第一次聽到他這樣描述。馬蒂亞斯 (Mattias) 態度比較保守,但很高興聽到您相信我們的投資組合。所以我把這個答案留給 Aradhana。

  • The tariffs. Yes, I think the industry is coming together. I mean, basically, we have a couple of issues to resolve as an industry. One is tariffs. And of course, there are ongoing discussions that are industry discussions.

    關稅。是的,我認為這個行業正在走向團結。我的意思是,基本上,作為一個行業,我們有幾個問題需要解決。一是關稅。當然,業界還在持續進行討論。

  • But the other piece is I think what is really important long term, it's probably less relevant near term, but it's mid- to long-term relevant is addressing this imbalance that exists between Europe and the US as it relates to funding, innovative medicines.

    但另一方面,我認為從長遠來看真正重要的事情是,它可能在短期內不太重要,但從中長期來看,重要的是解決歐洲和美國在資金、創新藥物方面存在的不平衡。

  • Again, as I said, it's a question for you. It's a question of sovereignty and sovereignty of the -- health sovereignty for their European citizens. It's not only a question of price. People think it's a question of price sometimes. No, it's also a question of delay.

    再說一遍,正如我所說,這是一個問你的問題。這是歐洲公民的主權和健康主權問題。這不僅僅是一個價格問題。人們有時認為這是一個價格問題。不,這也是一個延遲的問題。

  • I mean, in many countries in Europe, patients have to wait 2 years, 3 years to get access or it's a very restrictive. So I think with a reasonably modest increase of the share of GDP allocated to innovative medicines, the A lot of these things could be addressed and disappear. And I think that's an issue the industry is addressing collectively. And I believe I hope that we can continue working together to address those 2 issues.

    我的意思是,在歐洲的許多國家,患者必須等待 2 年、3 年才能獲得治療,或限制非常嚴格。因此,我認為,只要合理增加分配給創新藥物的 GDP 份額,許多此類問題就可以解決並消失。我認為這是整個產業正在共同解決的問題。我相信,我希望我們能夠繼續共同努力解決這兩個問題。

  • Aradhana?

    阿拉達納?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • So yes, thank you so much for your confidence in our $80 billion number. We are working hard to achieve that. I think as we've mentioned both this time and when we announced our full year results, 2025 will really be a very important year. And this time next year, we should have a very good sense of where we stand on the trajectory to that $80 billion ambition. .

    是的,非常感謝您對我們 800 億美元數字的信任。我們正在努力實現這一目標。我認為,正如我們這次以及宣布全年業績時所提到的,2025 年確實將是非常重要的一年。明年這個時候,我們應該對自己在實現 800 億美元目標的道路上所處的位置有非常清晰的認識。。

  • The $80 billion is a risk-adjusted number. So this year, we will reading out several studies, multiple in the portfolio, several in the pharma portfolio and of course, in oncology as well as the oral GLP product, which is in Phase II. So Again, not everything will work. But on a risk-adjusted basis, by this time next year, we'll have a very good idea and confidence where we are on that $80 billion ambition.

    800億美元是一個經過風險調整的數字。因此,今年我們將宣讀幾項研究,包括投資組合中的多項研究、製藥投資組合中的多項研究,當然還有腫瘤學以及處於第二階段的口服 GLP 產品。所以,再說一遍,並不是所有的事情都會成功。但經過風險調整後,到明年這個時候,我們將對實現 800 億美元的目標有非常好的認識和信心。

  • To your question on where we see variances versus our own plan, I think there are multiple products, particularly in the biopharma portfolio, I think some of the respiratory products some of the CVRM products, the oral PCSK9, I think now people are starting to appreciate that opportunity, the amyloidosis.

    對於您關於我們看到與我們自己的計劃相比存在哪些差異的問題,我認為有多個產品,特別是在生物製藥產品組合中,我認為一些呼吸產品、一些 CVRM 產品、口服 PCSK9,我認為現在人們開始意識到這個機會,即澱粉樣變性。

  • So I think there are several products in the biopharma and the rare disease portfolio as well as in the oncology portfolio, I think we're not really getting any credit for the investments we are making in our own ADC pipeline that Susan highlighted as well as other investments we're making in cell therapy. So there are several areas of variances, but those are the major ones. Thank you.

    因此,我認為生物製藥和罕見疾病產品組合以及腫瘤學產品組合中有幾種產品,我認為我們在 Susan 強調的我們自己的 ADC 管道以及我們在細胞療法方面所做的其他投資方面並沒有真正獲得任何讚譽。因此存在幾個差異領域,但這些是主要差異領域。謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Matthew Weston, UBS.

    瑞銀的馬修·韋斯頓。

  • Matthew Weston - Analyst

    Matthew Weston - Analyst

  • Thank you, Pascal. Two questions, please, the first for Susan on AVANZAR. Based on our feedback, a lot of investors are nervous and would like to basically see this one out of the way so they can concentrate on the rest of the rich catalyst path that you and Pascal laid out. Now clearly, you might disagree. But I wonder if there's any color you can give us on how events are tracking and when we might see the data within the second half of the year?

    謝謝你,帕斯卡。請問有兩個問題,第一個問題是關於 AVANZAR 的蘇珊 (Susan)。根據我們的回饋,許多投資人都很緊張,他們希望盡快解決這個問題,這樣他們就可以專注於您和帕斯卡製定的其餘富催化劑路徑。現在很明顯,你可能會不同意。但我想知道您能否告訴我們事件進展如何,以及我們何時可以在下半年看到數據?

  • And then a second one for Aradhana, please. The 2024 annual report calls out $561 million of benefit of intellectual property incentive regimes in your tax paid. President Trump has called out low US tax payment by pharma as a frustration alongside manufacturing locations. Pascal obviously has made the reassuring comments around manufacturing and tariffs, but have you had any interaction with US authorities on how you use IP licenses to take profit out of the US?

    接下來請 Aradhana 發言。2024 年年度報告顯示,您繳納的稅款中享受了 5.61 億美元的智慧財產權激勵制度的優惠。川普總統表示,美國製藥公司繳納的低稅額和生產地點問題都令人失望。帕斯卡顯然已經就製造業和關稅問題發表了令人安心的言論,但您是否與美國當局就如何利用知識產權許可從美國獲取利潤進行過任何互動?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So AVANZAR, Susan, you could cover this; and of course, Aradhana, second one. I don't want to steal the Aradhana's thunder, but I think it's important maybe to signal that of our distribution of taxes around the world, in the US, we have a fair amount of our proportion of taxes spread in the US

    所以 AVANZAR,Susan,你可以報道這個;當然還有第二個,Aradhana。我不想搶阿拉達納的風頭,但我認為,也許有必要表明,我們在世界各地的稅收分配中,在美國,我們有相當一部分稅收分佈在美國

  • So I don't think we are in a position where people could say we are optimizing tax to the extent we don't pay our fair share of taxes in the US We do pay our fair share of taxes in the US. I'm sure Aradhana doesn't want to give the details, but I can tell you, we pay a fair share of taxes in the US, AVANZAR for Susan and the second question, Aradhana.

    因此,我認為我們不能因為沒有在美國繳納公平份額的稅款就說我們在優化稅收,我們確實在美國繳納了公平份額的稅款。我確信 Aradhana 不想透露細節,但我可以告訴你,我們在美國繳納了相當一部分稅款,Susan 的 AVANZAR 和第二個問題,Aradhana。

  • Susan Galbraith - Executive Vice President - Oncology and Research and Development

    Susan Galbraith - Executive Vice President - Oncology and Research and Development

  • Yes. Thank you, Matthew. So in terms of AVANZAR, just a couple of things. AVANZAR could ahead of time, which shows the enthusiasm that the investigator population had for this study. We guide by half, and we expect -- we do expect the results in the second half of this year and I see no reason why that's going to be delayed beyond the end of the year.

    是的。謝謝你,馬修。就 AVANZAR 而言,只有幾件事。AVANZAR 能夠提前完成,體現了研究者群體對這項研究的熱情。我們預計今年下半年會公佈結果,我認為沒有理由將其推遲到年底之後。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • On your second question, as Pascal mentioned, we do pay our fair share of taxes in proportion to our revenues in the US. We do take advantage, obviously, of transfer prices. But I think the numbers you are mentioning that are mentioned in the annual report, relate much more to things like patent boxes and where governments do provide incentives for research and so forth in R&D funding. So we're always trying to optimize how we manage and plan our taxes globally. So that's all the detail we can provide at this time.

    關於你的第二個問題,正如帕斯卡所說,我們確實按照我們在美國的收入比例繳納了公平的稅。顯然,我們確實利用了轉讓價格。但我認為,您提到的年度報告中的數字更與專利盒以及政府在研發資金方面提供的研發獎勵措施等有關。因此,我們一直在努力優化全球稅務管理和規劃方式。這就是我們目前可以提供的所有細節。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Matthew, I mean, I don't think I would disagree with you that AVANZAR, it's an important event for us this year, but we have many other events is another major event. We have major -- quite a number of major events throughout the year in the pipeline. We've already derisked the major one with DB09 of course, so it's an important event, I don't disagree, and we all are waiting for that readout for sure, but we have many others.

    馬修,我的意思是,我認為我不會不同意你的觀點,AVANZAR 對我們來說是今年的一個重要活動,但我們還有許多其他活動是另一個重大活動。我們全年都在籌備許多重大活動。當然,我們已經降低了 DB09 的主要風險,所以這是一個重要的事件,我不反對,我們都在等待那個讀數,但我們還有許多其他的讀數。

  • Justin Smith, Bernstein.

    賈斯汀·史密斯,伯恩斯坦。

  • Justin Smith - Analyst

    Justin Smith - Analyst

  • Thanks very much. Just a quick one for Marc, Ultomiris, just wondered if you could just provide a bit more color with regards to increased competition. Is that potentially due to price? Just asking because obviously, one of your competitors, particularly in the MG space is emphasizing that more innovation should be driving market expansion?

    非常感謝。馬克、Ultomiris,我只想快速問你一個問題,想知道你是否可以提供更多關於競爭加劇的資訊。這可能是由於價格原因嗎?只是問一下,因為很明顯,您的一個競爭對手,特別是在 MG 領域,正在強調應該透過更多的創新來推動市場擴張?

  • Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

    Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

  • So the -- first of all, thank you for the question. The competition that we have is obviously from Ultomiris is mostly from novel medicines. The category of myosthenia gravis, as an example, has grown dramatically over the last three or four years, the branded part of the market is growing very strongly every year.

    所以——首先,感謝您的提問。我們面臨的競爭顯然來自 Ultomiris,主要是新藥。以重症肌無力類別為例,在過去的三、四年裡,該類別的市場規模急劇增長,品牌部分每年都呈現強勁成長動能。

  • The Ultomiris has key position in this market, but obviously, other mechanisms have an attraction for people who are switching from the steroids or immunosuppressant as a first-line treatment. Ultomiris is also competing in that segment, but it's not the only mechanism available. So we have -- it's mostly a competition from novel medicine rather than biosimilars.

    Ultomiris 在這個市場上佔據關鍵地位,但顯然,其他機制對於那些從類固醇或免疫抑制劑作為一線治療的患者也具有吸引力。Ultomiris 也在該領域競爭,但它並不是唯一可用的機制。因此,我們面臨的主要是新型藥物的競爭,而不是生物相似藥的競爭。

  • Biosimilars obviously competes against Soliris. But as we have now converted mostly Soliris to Ultomiris in the four indications, this -- the competition in the future will be coming from the novel medicines.

    生物相似藥顯然與 Soliris 存在競爭。但由於我們現在已經將四種適應症中的大部分 Soliris 轉換為 Ultomiris,未來的競爭將來自新型藥物。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Seamus Fernandez, Guggenheim.

    謝默斯·費爾南德斯,古根漢美術館。

  • Seamus Fernandez - Analyst

    Seamus Fernandez - Analyst

  • Oh, thanks for the questions. So two quick questions. So Pascal, you commented on the pricing dynamics and concerns that have been raised. But you haven't commented on the opportunity for the HHS Secretary to work with Congress to align the incentives for small molecules with large molecules.

    哦,謝謝你的提問。所以有兩個簡單的問題。帕斯卡,您對定價動態和已經提出的擔憂發表了評論。但您還沒有評論衛生與公眾服務部部長與國會合作協調小分子和大分子激勵措施的機會。

  • Just wondering your thoughts on that as well as kind of a backward-looking dynamic with regard to already negotiated small molecules in the context, including Calquence? And then separately, I just wanted to ask a little bit for directional predictions that you believe DB09 may have, as it relates to potential success of Enhertu in the adjuvant setting?

    只是想知道您對此的看法,以及對於已經協商好的小分子(包括 Calquence)的回顧性動態?然後另外,我只想問一下您認為 DB09 可能具有的方向性預測,因為它與 Enhertu 在輔助治療中的潛在成功有關?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Seamus. Yes, I mean, the first point, thank you for reminding us of this. I mean it is definitely -- I mean, Congress still has to vote on this, of course, and confirm it. But it is definitely something that goes in the right direction for the industry in general and for us in particular.

    謝謝你,西莫斯。是的,我的意思是,第一點,感謝您提醒我們這一點。我的意思是,這肯定是——我的意思是,國會當然還必須對此進行投票並確認。但對於整個產業,尤其是對我們來說,這無疑是朝著正確方向發展的。

  • I mean, of course, our existing medicines, but I can't think of camizestrant which will be a very major medicine, we believe, which have any benefit from this. I think also we can take heart of what we could see as potential willingness to address this 340B issues. I mean it is something that we, as an industry, but certainly we as a company, have been pushing back on because we believe that a number of participants are abusing this -- have been using this 340B regulation.

    我的意思是,當然,我們現有的藥物,但我認為卡米司特倫不會從中受益,我們相信,卡米司特倫將成為一種非常重要的藥物。我認為,我們也可以對解決 340B 問題的潛在意願感到鼓舞。我的意思是,作為一個行業,當然作為一家公司,我們一直在反對這種做法,因為我們認為許多參與者正在濫用這項 340B 法規。

  • And it was nice to see that there is a report now that has been provided to the Congress that confirms what we have been saying for a long time. So there's a couple of things that actually are going in the right direction, you're absolutely right. And I think the industry would benefit and we would benefit. DB09, Susan, do you want to cover that?

    我很高興看到現在已經向國會提交了一份報告,證實了我們長期以來的說法。所以,實際上有幾件事正在朝著正確的方向發展,你說得完全正確。我認為整個產業都會受益,我們也會受益。DB09,蘇珊,你想報這個嗎?

  • Susan Galbraith - Executive Vice President - Oncology and Research and Development

    Susan Galbraith - Executive Vice President - Oncology and Research and Development

  • Yes, sure. So just as a reminder, in the DB09 study, you're taking on a 3-drug regimen. I think the fact that we've seen a highly statistically significant and clinically meaningful improvement with the combination of pertuzumab and Enhertu speaks to the power Enhertu to address that and builds on the data that we have with DB03, DB04 and DB06.

    是的,當然。因此提醒一下,在 DB09 研究中,您需要接受 3 種藥物治療方案。我認為,我們已經看到帕妥珠單抗和 Enhertu 的組合具有高度統計意義和臨床意義的改善,這一事實說明了 Enhertu 能夠解決這個問題,並且建立在我們擁有的 DB03、DB04 和 DB06 數據之上。

  • If you look at the other early trials, DB11 is in patients that are in the neoadjuvant setting and again, aims to improve on the current standard of care in that neoadjuvant setting, which has multiple drugs, it's actually five drugs is the current standard of care with AC as well as the THP regimen.

    如果你看看其他早期試驗,你會發現 DB11 是針對處於新輔助治療環境中的患者,其目的是改善新輔助治療環境中的當前護理標準,該環境有多種藥物,實際上有五種藥物是 AC 和 THP 方案的當前護理標準。

  • And then DB05 is in patients who have residual disease after surgery. So post-neoadjuvant and around half of those are considered high risk, which is the node-positive patients. So that's a subgroup whether trial with trastuzumab DM1 demonstrated less benefit. And given the DB03 data where we've already had a head-to-head comparison with that, we do believe that Enhertu can make a difference in both of those settings. So I hope that gives you context for the potential readouts for DB05 and DB11.

    DB05 適用於手術後有殘留疾病的患者。因此,新輔助治療後,約有一半的患者(即淋巴結陽性患者)被視為高風險。因此這是一個亞組,曲妥珠單抗 DM1 試驗是否顯示出較少的益處。鑑於我們已經對 DB03 數據進行了正面比較,我們確實相信 Enhertu 可以在這兩種設定中發揮作用。因此,我希望這能為您提供有關 DB05 和 DB11 的潛在讀數的背景資訊。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Simon Baker, Redburn.

    西蒙貝克,雷德伯恩。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Pascal, I hit the wrong button. Two questions, if I may, please, firstly, one for Dave. You talked about the gradual impact on discontinuation rates from Part D redesign, I appreciate it's a bit early to start talking about what the impact is, but could you talk about the point from which we start in terms of where we are now in terms of financially motivated discontinuation rates?

    帕斯卡,我按錯按鈕了。請問我有兩個問題,首先,一個是問戴夫的。您談到了 D 部分重新設計對停產率的逐步影響,我知道現在開始談論其影響還為時過早,但您能否就我們現在在財務動機停產率方面的狀況談談我們的起點?

  • And then secondly, one for Sharon. I noticed from the trial appendix that MEDI1814 in Alzheimer's and MED0618 in migraine have both been removed from the pipeline. As far as I can see, that removes all neuroscience assets from the biopharma pipeline. Is that just coincidence or does that mark a strategic shift in R&D priorities?

    其次,我要向 Sharon 致謝。我從試驗附錄中註意到,用於治療阿茲海默症的 MEDI1814 和用於治療偏頭痛的 MED0618 均已從管道中移除。據我所知,這將把所有神經科學資產從生物製藥管道中移除。這僅僅是巧合還是標誌著研發重點的策略轉變?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Dave.

    戴夫。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Simon, we have seen in the past, and we haven't given specific percentages on this, but we've seen, I would say, kind of an important minority of the total oral packs that we ship are historically free drug that we ship. And so those are things that, historically, we've seen as abandonment.

    西蒙,我們過去曾看到過這種情況,雖然我們沒有給出具體的百分比,但我想說,我們所運送的口服包裝總量中,有相當一部分是歷史上免費的藥物。所以從歷史上看,這些都是我們視為放棄的。

  • Now whether or not that's been abandoned at the first script or that's at a refill because there's a discontinuation that happens down the road, that's much more difficult to parse out. But we've absolutely seen -- and we've put into place a number of measures as co-pay capping came down from uncapped to last year's 33 to this year's 2000, we have absolutely seen a reduction in that free goods utilization. I don't have a big expectation of seeing a lot of further improvement in free goods because it's really come down pretty significantly.

    現在,無論這是否在第一個腳本中被放棄,或者是否因為以後發生中斷而重新填充,這都很難分析。但我們確實看到——我們已經採取了一系列措施,隨著共同支付上限從無上限降至去年的 33 到今年的 2000,我們確實看到免費商品使用率的減少。我對免費商品的進一步改善並不抱太大期望,因為它的數量確實已經大幅下降了。

  • I think that the best opportunities for us to grow coming from here is going to be, as always, new indications. Tagrisso continuing to drive FLAURA2, LAURA, ADAURA, AMPLIFY and ECHO on Calquence. That's our opportunities to really come from this rebaseline spot that we're at to now drive growth from here over the course of the period of the multiple quarters that sit in front of us.

    我認為,從現在開始我們實現成長的最佳機會將一如既往地是新的跡象。Tagrisso 繼續在 Calquence 上駕駛 FLAURA2、LAURA、ADAURA、AMPLIFY 和 ECHO。這是我們真正從現在的重新基線點出發,在未來的多個季度中推動成長的機會。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Dave. And just to repeat again, so that you don't forget these the messages. Tagrisso is growing by 20% in volume, Calquence by more than 20% in volume. So Tagris and and this momentum, add what Dave just said in terms of new indications. And you can imagine that as we weather this Part D repricing, which is a one-off this year, that will take us into '26-'27 with a renewed momentum for these very important medicines.

    謝謝你,戴夫。再重複一遍,這樣你就不會忘記這些資訊。Tagrisso 的銷量成長了 20%,Calquence 的銷量成長了 20% 以上。因此,Tagris 和這種勢頭,加上 Dave 剛才所說的新跡象。你可以想像,隨著我們度過今年一次性的 D 部分重新定價,我們將在 2026-2027 年為這些非常重要的藥物帶來新的發展勢頭。

  • Sharon.

    莎倫。

  • Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Thanks for the question, Simon. In R&D, prioritization is always important. So as you noticed, we have closed our neuro programs and identified partners for some of them, this represents the closure of our neuroscience group at AstraZeneca. And importantly, it allows us to focus on our core therapeutic areas and fund our high-value programs.

    謝謝你的提問,西蒙。在研發中,優先排序始終很重要。正如您所注意到的,我們已經關閉了我們的神經項目,並為其中一些項目確定了合作夥伴,這代表著我們阿斯特捷利康神經科學小組的關閉。重要的是,它使我們能夠專注於我們的核心治療領域並為我們的高價值項目提供資金。

  • You've heard our excitement about things like weight management, about dyslipidemia, about our very important respiratory portfolio and our growth in immunology. And so this prioritization helps us to reinvest in the programs that we think are important for AstraZeneca.

    您已經聽說了我們對體重管理、血脂異常、我們非常重要的呼吸產品組合以及我們在免疫學方面的發展等方面的興奮之情。因此,這種優先排序有助於我們重新投資於我們認為對阿斯特捷利康很重要的項目。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Sharon. Yes, we have things that you haven't seen yet because they are in early development, and we don't speak much about this. But things like inhaled biologics, the immune portfolio that has been really progressing and it's shaping up nicely. So there's a lot of things we can fund and we cannot be everywhere. So CNS really is probably better managed by other companies that have a focus on that.

    謝謝你,莎倫。是的,我們有一些您還沒有看到的東西,因為它們還處於早期開發階段,我們對此沒有多加評論。但吸入生物製劑、免疫產品組合等確實取得了進展,而且進展良好。因此,我們可以資助很多事情,但我們不可能涵蓋所有地方。因此,CNS 確實可能更適合由其他專注於此的公司來管理。

  • Rajesh Kumar, HSBC.

    拉傑什·庫馬爾,匯豐銀行。

  • Rajesh Kumar - Analyst

    Rajesh Kumar - Analyst

  • Just on PCSK9, if you could give us some idea on the time lines of when are we expecting the trials and updates in terms of the development time lines, similarly on SERENA-6 as well of filing time lines if we have, any clarity on that one?

    就 PCSK9 而言,您能否告訴我們預計試驗和更新的開發時間表,同樣,對於 SERENA-6 也一樣,如果我們有提交時間表的話,對此有什麼清楚的說明嗎?

  • And a second slightly broader question. I appreciate there is a lot of interest on AVANZAR, and we are all nervously waiting for the readout. But we can easily confuse the details for the bigger picture. So can you elucidate your broader strategy around that? What -- where do you think -- what is the total potential of the product across indications and how do you see that develop, I would appreciate that?

    第二個問題稍微廣泛一些。我很感激大家對 AVANZAR 很感興趣,我們都在焦急地等待結果。但我們很容易混淆細節和整體情況。那麼,您能闡明您在這方面的更廣泛的策略嗎?您認為該產品在各個適應症方面的整體潛力是什麼?您認為該產品將如何發展?我將非常感激。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So the first question, maybe, Sharon, you can take; SERENA-6 for Susan; and the last one is for you, Dave, I guess.

    所以第一個問題,也許莎倫,你可以回答;蘇珊的 SERENA-6;我想,最後一個是給你的,戴夫。

  • Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Sure. And thank you for your interest in PCSK9. You hear our excitement about this molecule. And as I mentioned today, we are launching three Phase III studies and moving at pace. We expect to have our pivotal study in LDL lowering initiated by the end of this year.

    當然。感謝您對 PCSK9 的關注。您聽到了我們對這種分子的興奮之情。正如我今天提到的,我們正在啟動三項第三階段研究,並且進展順利。我們預計在今年年底前啟動降低 LDL 的關鍵研究。

  • Now, we won't comment broadly on the readout time lines for these pivotal studies. But you heard us tell you that we're moving forward with a sense of urgency that we are running a combined primary and secondary outcome study. And that we think that we'll be able to launch with our LDL-lowering study, while moving ahead in parallel with our outcome study that will help facilitate market uptake. So continue to watch this space.

    現在,我們不會對這些關鍵研究的讀出時間軸進行廣泛評論。但您聽到我們告訴您,我們正在緊急推進一項綜合的主要和次要結果研究。我們認為,我們將能夠啟動降低 LDL 水平的研究,同時同步推進我們的結果研究,這將有助於促進市場接受。因此請繼續關注這個領域。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • So Rajesh, on the bigger picture question on Datroway, and I appreciate you asking it. I mean I think that understandably because AVANZAR the first frontline lung cancer study to read out, there is a lot of interest within it. But I do think it's important to not look at it just within isolation. There's multiple opportunities for Datro as a monotherapy, particularly as we take a look at that now look at prospective definition of a biomarker population. And Susan commented on this before, and we've quite a lot in the past.

    Rajesh,關於 Datroway 的更大問題,我很感謝你提出這個問題。我的意思是,我認為這是可以理解的,因為 AVANZAR 是第一份一線肺癌研究,人們對它很感興趣。但我確實認為,重要的是不要孤立地看待它。Datro 作為單一療法有多種機會,特別是當我們現在研究生物標記群體的預期定義時。蘇珊之前就對此發表過評論,我們過去也發表過很多評論。

  • The work that we've done with the QCS biomarker, I think, is really evidence to how we're leveraging this convergence of science data and technology to be able to try to better and more precisely identify patients who can benefit potentially from Datroway.

    我認為,我們在 QCS 生物標記方面所做的工作確實證明了我們如何利用這種科學數據和技術的融合,以便能夠更好、更準確地識別可能從 Datroway 中受益的患者。

  • Also though in combination, and there's multiple combinations that we look at. There's combinations with IO. There's also combinations with Tagrisso in EGFR-mutated and we're looking at combinations, not just with PD-1, PD-L1, but also with our bispecific portfolio.

    儘管是組合,但我們還是會考慮多種組合。有與 IO 的組合。在 EGFR 突變中也有與 Tagrisso 的組合,我們正在研究組合,不僅與 PD-1、PD-L1,還與我們的雙特異性產品組合。

  • So I think that that's the context within which I put data. We're underway already in the US in breast cancer. I would note that we are seeing that over half of the accounts that have placed their first order for Data have also had repeat utilization, so that's a really encouraging sign.

    所以我認為這就是我放置數據的背景。在美國我們已經開始研究乳癌。我想指出的是,我們發現超過一半首次訂購數據的帳戶也進行了重複使用,這是一個非常令人鼓舞的跡象。

  • And it also underscores the high unmet need and willingness to be able to bring a more precise chemotherapy with a profile like Datroway's to replace classical chemotherapy in settings where classical chemotherapy has long been relied upon.

    這也凸顯了尚未滿足的巨大需求,以及人們希望在長期依賴傳統化療的環境中,能夠以 Datroway 等更精準的化療來取代傳統化療的意願。

  • And I guess, Pascal made the last point, which is, let's not look at it in isolation. There's an entire portfolio of many readouts that we've got an opportunity also, and you've already seen whether it's MATTERHORN, SERENA-6, DB09, AMPLIFY that also go alongside that.

    我想,帕斯卡提出了最後一點,那就是,我們不要孤立地看待它。我們也有機會獲得許多讀數的完整組合,並且您已經看到了與之配套的 MATTERHORN、SERENA-6、DB09 和 AMPLIFY。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Dave.

    謝謝,戴夫。

  • Luisa Hector, Berenberg.

    路易莎·赫克托(Luisa Hector),貝倫貝格(Berenberg)。

  • Sorry, yes, SERENA-6, Susan, go ahead, yes.

    抱歉,是的,SERENA-6,Susan,請繼續,是的。

  • Susan Galbraith - Executive Vice President - Oncology and Research and Development

    Susan Galbraith - Executive Vice President - Oncology and Research and Development

  • So thank you for the question about SERENA-6. We're very excited to see the data come to the ASCO plenary. And I think selection of the ASCO plenary reflects what they are seeing about the the overall benefit risk that's seen in that trial. So obviously, as we always do when we got a readout, we'll be in discussions with regulatory authorities, and I can't comment on that specifically because that's ongoing.

    感謝您提出有關 SERENA-6 的問題。我們非常高興看到這些數據來到 ASCO 全體會議上。我認為選擇 ASCO 全體會議反映了他們對該試驗中整體利益風險的觀察。因此,顯然,當我們獲得讀數時,我們會像往常一樣與監管機構進行討論,我無法對此具體發表評論,因為這仍在進行中。

  • But what I would say is that when you see compelling data, First of all, we will work very diligently to get the submission happening rapidly. And then we'll also get -- we've had other examples of when we see compelling data, we get opportunities for things like priority review. So let's wait and see how that progresses. And I'm very happy to talk about the SERENA-6 data once you've seen the data at ASCO.

    但我想說的是,當你看到令人信服的數據時,首先,我們會非常努力地盡快提交。然後我們還會得到——我們有其他例子,當我們看到令人信服的數據時,我們就會獲得優先審查等機會。因此,讓我們拭目以待,看看事情會如何發展。一旦您在 ASCO 上看到 SERENA-6 數據,我很樂意與您討論。

  • And if I could just take one more opportunity, I just will say that as well the overall enthusiasm from investigators about the camizestrant program is substantial. The adjuvant studies are a really exciting opportunity, and I'm very pleased to share that we've actually achieved our target sample size in the CAMBRIA1 study, just very recently, which is also ahead of plan. So I think it just reflects the enthusiasm that we're seeing about this overall program. Thanks.

    如果我可以再說一次的話,我只想說,研究人員對 camizestrant 計劃的整體熱情也很高。輔助研究是一個非常令人興奮的機會,我很高興地告訴大家,我們最近在 CAMBRIA1 研究中實際上已經實現了我們的目標樣本量,這也提前完成了計劃。所以我認為這反映了我們對整個計劃的熱情。謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • I'm sure you've all heard that Susan loves camizestrant. So, Luisa, over to you now.

    我確信你們都聽說過蘇珊喜歡 camizestrant。那麼,路易莎,現在輪到你了。

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • I have two questions, please. On obesity, has your perspective on the market and AstraZeneca's potential role in that market evolved given recent competitor data?

    我有兩個問題請問。關於肥胖問題,根據最近的競爭對手數據,您對市場以及阿斯特捷利康在該市場中的潛在作用的看法是否有所變化?

  • And then on China, you for the update in the press release. Do you think we can draw a line here under all the investigations or is there anything else we should have in mind as we go through the year? And perhaps just a quick comment on your market share holding up in Q1 in China, is that all intact and your latest expectations on the timing of (inaudible). Thank you.

    關於中國,請您在新聞稿中更新一下情況。您認為我們可以在所有調查中劃出一條線嗎?或者在我們度過這一年的過程中我們還應該考慮其他什麼嗎?也許只是想簡單評論一下你們在中國第一季的市佔率是否保持穩定,以及你們對(聽不清楚)。謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Ruud, do you want to take that first one?

    魯德,你想拿第一個嗎?

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yes, absolutely. So, Luisa, we are very excited about our weight management portfolio. Last time Sharon explained in quite a bit of detail why we are so excited. I think we have -- first of all, a broad portfolio. I think our oral GLP-1 potentially is fit for purpose in order to combine it with other products in our portfolio, clearly, our SGLT2.

    是的,絕對是。所以,路易莎,我們對我們的體重管理產品組合感到非常興奮。上次 Sharon 詳細解釋了我們為何如此興奮。我認為我們首先擁有廣泛的產品組合。我認為我們的口服 GLP-1 可能適合與我們產品組合中的其他產品(顯然是我們的 SGLT2)結合。

  • The market size in itself is very, very substantial. As you know, very well analysts are forecasting anything between $50 billion and $150 billion and I think our strategy is differentiated in such a way that, yes, we are looking in what we call the hardcore obesity market. So patients with a BMI of over 35, but equally, patients with a BMI between 27 and slightly above that, are going to benefit substantially from losing a certain amount of weight.

    市場規模本身就非常非常大。如你所知,分析師預測該市場規模將在 500 億美元至 1500 億美元之間,我認為我們的策略有所不同,是的,我們正在尋找所謂的重度肥胖市場。因此,BMI 超過 35 的患者,以及 BMI 在 27 至略高於 35 之間的患者,都將從減輕一定量的體重中受益匪淺。

  • And if you combine that with other products in our portfolio, whether it is potentially in oral PCSK9, I think we have a very powerful combination, not only in order to reduce weight, but also to move to protection of of different organs.

    如果將其與我們產品組合中的其他產品結合,無論是否可能是口服 PCSK9,我認為我們都擁有非常強大的組合,不僅可以減輕體重,還可以保護不同的器官。

  • Now having said that, I think the other opportunity is, clearly, the footprint we are having in the emerging markets. The likelihood that an oral PCSK9 will be priced at a lower level versus the current available injectables is a reasonable assumption. And hence, we are also aiming for a very large population in the emerging markets. So all in all, very exciting.

    話雖如此,我認為另一個機會顯然是我們在新興市場的足跡。口服 PCSK9 的價格可能低於目前可用的注射劑,這是一個合理的假設。因此,我們也瞄準了新興市場的龐大人口。總而言之,非常令人興奮。

  • Of course, the ongoing Phase II trials are running as we speak, both in obesity and diabetes. So we need to wait for that. But we are ready in order to move with speed to start our Phase III trials if the data is successful.

    當然,針對肥胖症和糖尿病的第二階段試驗正在進行中。所以我們需要等待。但如果數據成功,我們已做好準備,快速啟動第三階段試驗。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Ruud. Just maybe one additional point is that as Ruud said, we have a big footprint our mission is always to try and bring our medicines to as many people as possible and if you look at the cholesterol market, the PCSK market, it's a good parallel. Injectable PCSK great products, but outside the US, I mean, their penetration is more limited because of cost and injections. So an oral agent will enable us to bring this type of medicines to a lot more patients around the world. The other benefit maybe to add is that an oral agent is probably a better option in term of compliance long term.

    謝謝你,魯德。也許還有一點,正如魯德所說,我們的足跡很廣,我們的使命始終是盡力將我們的藥物帶給盡可能多的人,如果你看看膽固醇市場、PCSK 市場,這是一個很好的類比。注射用 PCSK 是很好的產品,但在美國以外,我的意思是,由於成本和注射的原因,它們的滲透率比較有限。因此,口服藥物將使我們能夠將這類藥物帶給世界各地的更多患者。另一個可能的好處是,從長期依從性的角度來看,口服藥物可能是更好的選擇。

  • I think the overweight or obesity are chronic conditions, you have to take those medicines for a long, long time, otherwise, you regain weight and we've seen this over and over again. So an oral agent that you take in combination with your other medicines is more likely to enable patients to stay on treatment for a long period of time, especially if the price is affordable, of course.

    我認為超重或肥胖是一種慢性疾病,你必須長期服用這些藥物,否則你的體重就會反彈,這種情況我們已經見過很多次了。因此,與其他藥物聯合服用的口服藥物更有可能使患者長期接受治療,當然,特別是在價格實惠的情況下。

  • Iskra Reic - Executive Vice President - Vaccines and Immune Therapies

    Iskra Reic - Executive Vice President - Vaccines and Immune Therapies

  • Yes, so thanks, Luisa, for the question. Let me first start with the comment on the update on the investigation. As you recognized, we announced two important updates in our results announcement. And from what we know, customer office and public security bureau have really concluded their respective investigation both related to the drug importation allegations as well as the personal information infringement allegation. And these cases are now -- have now been referred to the prosecutor. Important update that we provided in our result announcement is that we have been informed that there was no illegal gain to the company from the personal information infringement allegations.

    是的,感謝 Luisa 提出這個問題。首先,我想就調查的最新進展發表評論。如您所知,我們在業績公告中宣布了兩項重要更新。據我們了解,海關總署和公安局確實已經結束了對毒品進口指控和個人資訊侵犯指控的調查。這些案件現在已經提交給檢察官。我們在業績公告中提供的重要更新是,我們已獲悉,公司並未從個人資訊侵權指控中獲得非法收益。

  • On your second question about the market share, as you saw in our quarter-one announcement, we saw the strong performance in China -- strong quarter in China with 5% of the growth and our underlying business is basically performing even better because if you adjust for the a permit court, which is declining due to the low infection season and the market decline, our underlying business in China is growing 9%.

    關於您的第二個問題,關於市場份額,正如您在我們第一季的公告中所看到的,我們看到了中國市場的強勁表現——中國市場本季度增長了 5%,而且我們的基礎業務表現甚至更好,因為如果考慮到由於感染低迷季節和市場下滑而導致的許可證費用下降,我們在中國的基礎業務增長了 9%。

  • And that is driven primarily by the continuous strong performance of Forxiga, and I would argue outstanding launch of it and here to by inclusion in NRDL in the January and our ability to basically achieve hospital listings in the first quarter and clearly help a lot of patients with huge unmet needs in China in that space.

    這主要得益於福西加持續強勁的表現,我認為它的出色推出以及在一月份被納入國家醫保目錄,以及我們在第一季度基本實現醫院上市的能力,顯然幫助了中國該領域大量未滿足需求的患者。

  • On top of that, we are seeing continuous improvement of the market share. We are still leading in the respiratory field both with Symbicort and Breztri. We see very encouraging data and the market share increase from Breztri as well as improvement in the usage of the triple therapy. And given the huge unmet need in China related to the COPD, we do see that -- we do see a huge unmet need going forward.

    除此之外,我們也看到市佔率不斷提高。憑藉 Symbicort 和 Breztri,我們在呼吸領域仍然處於領先地位。我們看到了非常令人鼓舞的數據,Breztri 的市佔率有所增加,三聯療法的使用率也有所提高。鑑於中國在慢性阻塞性肺病 (COPD) 方面存在巨大的未滿足需求,我們確實看到未來存在巨大的未滿足需求。

  • When we look on other important growth drivers, as you all know, Tagrisso is an important growth driver in China and we do see continuous growth of Tagrisso given by the new indication as well as improvement in the market share despite of fearless competition and six third-generation TKIs from the local companies that are available in the market.

    當我們看待其他重要的成長動力時,正如大家所知,Tagrisso 是中國的一個重要成長動力,儘管面臨激烈的競爭以及市場上有來自本土公司的六種第三代 TKI,但我們確實看到 Tagrisso 的新適應症帶來的持續增長以及市場份額的提高。

  • So all in all, we feel very comfortable and confident in the performance in the first quarter. And as we always talked about, we see, we feel confident and comfortable with the opportunity going forward in China, given the unmet need and given our portfolio and pipeline that fits that need.

    總而言之,我們對第一季的表現感到非常滿意和有信心。正如我們經常談論的那樣,考慮到尚未滿足的需求以及我們滿足這一需求的產品組合和產品線,我們對中國未來的機會充滿信心和信心。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Iskra. Maybe just to add something that Iskra will not tell you because she is modest, but she's done an amazing job, and the team is very motivated locally. I was there not long ago. And it's important because that's really what is going to sustain our growth moving forward.

    謝謝你,Iskra。也許只是想補充一點,伊斯克拉不會告訴你,因為她很謙虛,但她做得非常出色,而且當地的團隊也非常積極。我不久前去過那裡。這很重要,因為這才是真正支撐我們未來成長的動力。

  • The team is -- has gone through a period of trauma, as you can imagine, we've all been sort of traumatized by this event. And -- but people have quickly recovered and they're very much focused on delivering on our goals and everybody is very committed and very energized today.

    你可以想像,整個團隊都經歷了一段創傷期,我們都因為這次事件而受到了創傷。而且——但是人們很快就恢復了,他們非常專注於實現我們的目標,今天每個人都非常投入並且充滿活力。

  • Peter Veldult, BNP.

    英國國家黨的彼得·維爾杜爾特(Peter Veldult)。

  • Unidentified Participant

    Unidentified Participant

  • Yeah, thanks, Pascal. Peter (inaudible) Exane. Three questions. Just firstly for you, we've seen the first PDUFA delay from FDA this week that wasn't due to the need for further clinical or manufacturing data. So just in light of all the personnel changes, are you not seeing any worrying disruptions or delays with respect to Astra's interaction with the agency?

    是的,謝謝,帕斯卡。彼得(聽不清楚)Exane。三個問題。首先,我們本週看到 FDA 首次推遲 PDUFA,這並不是因為需要進一步的臨床或製造數據。那麼,考慮到所有這些人事變動,您是否沒有看到阿斯特捷利康與該機構的互動出現任何令人擔憂的中斷或延遲?

  • And then look, I know you are called it out when we had the question lined up ahead of the upcoming Phase III readout, does the sort of recent lorandustat data from Minerales, is that the right way of thinking about selling the bar or are you hoping to show something more? I just wanted to get a sense of your expectations going into that readout.

    然後看看,我知道當我們在即將到來的第三階段讀數之前提出問題時,您就被問到了這個問題,Minerales 最近提供的 lorandustat 數據是否是銷售該金條的正確思路,還是您希望展示更多信息?我只是想了解你對該讀數的期望。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So can I propose maybe, Susan, you cover the first question in general. And then, Sharon, if you have anything to add FDA and you can also cover baxdrostat.

    因此,蘇珊,我是否可以建議你概括地回答第一個問題。然後,Sharon,如果您還有什麼要補充的,FDA,您也可以介紹baxdrostat。

  • Susan Galbraith - Executive Vice President - Oncology and Research and Development

    Susan Galbraith - Executive Vice President - Oncology and Research and Development

  • Yes. Thank you. So obviously, we continue to monitor the situation, but just based on the facts, we haven't seen any delays in the interactions that we've had with the FDA across our programs to date. Just to remind you that NIAGARA was approved ahead of the PDUFA date. We have multiple interactions with the FDA across our extensive portfolio.

    是的。謝謝。因此,顯然,我們會繼續監測情況,但僅基於事實,迄今為止,我們尚未發現與 FDA 在整個專案中的互動出現任何延遲。只是提醒您,NIAGARA 已在 PDUFA 日期之前獲得批准。我們在廣泛的產品組合中與 FDA 進行了多次互動。

  • And all of those meetings are happening in the time lines that we would expect and with the level of interaction that we would expect.

    所有這些會議都按照我們預期的時間安排舉行,並達到了我們預期的互動水平。

  • Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • So with regards to the FDA and will echo Susan's comments that to date, we have had on time conversations with the regulatory authorities. And to date, we haven't seen any delays. That said, we continue to be very alert to this and continue to move forward with our programs with a sense of urgency.

    因此,關於 FDA,我會回應蘇珊的評論,到目前為止,我們已經與監管機構進行了及時的對話。到目前為止,我們還沒有發現任何延誤。儘管如此,我們仍然對此保持高度警惕,並繼續以緊迫感推進我們的計劃。

  • To address your question about baxdrostat, in light of the data that was revealed earlier this month, we first think it's very encouraging to see momentum in aldosterone targeted therapies. It validates the critical unmet medical need that we have been focused on for some time. We think that this is a mechanism of action in which we are targeting aldosterone at its source, which we think is a very important mechanism for helping to control hypertension.

    為了回答您關於巴曲司他的問題,根據本月早些時候公佈的數據,我們首先認為看到醛固酮標靶治療的發展勢頭非常令人鼓舞。它證實了我們一段時間以來一直關注的關鍵未滿足的醫療需求。我們認為這是一種從源頭上針對醛固酮的作用機制,我們認為這是一種有助於控制高血壓的非常重要的機制。

  • We continue to believe that our molecule baxdrostat has the potential to be best-in-class and has a very competitive profile. We've shown data for this in Brighton, where we saw a placebo-corrected reduction of 11 millimeters of mercury and systolic blood pressure at the 2-milligram dose.

    我們始終相信,我們的分子巴曲司他具有成為同類最佳藥物的潛力,並且具有非常強的競爭力。我們在布萊頓展示了這方面的數據,我們發現在 2 毫克劑量下,安慰劑校正後的血壓和收縮壓降低了 11 毫米汞柱。

  • With this molecule, we think we are seeing impressive mercury lowering at a low dose. This sets us up well for treatment with both monotherapy and combinations. Our molecule has a half-life that is at least double that of competitors. And we think that's really important for 24-hour control of hypertension.

    有了這種分子,我們認為我們可以看到低劑量下汞含量顯著降低。這為我們採用單一療法和聯合療法進行治療奠定了良好的基礎。我們的分子的半衰期至少是競爭對手的兩倍。我們認為這對 24 小時控制高血壓非常重要。

  • And we don't see clinically relevant drug-drug interactions with baxdrostat, which, again, we think highlighted potential to be a best-in-class molecule. So we think we're in a very competitive position. We look forward to reading out the Phase III pivotal data for BAX HTN later this year.

    而且我們沒有發現與巴曲司他有臨床相關的藥物交互作用,我們再次認為這凸顯了其成為同類最佳分子的潛力。因此我們認為我們處於非常有競爭力的地位。我們期待今年稍後讀出 BAX HTN 的第三階段關鍵數據。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Sharon. So I'd like to maybe go first of all, thanking you for all your interest and your great questions. And maybe in closing, I just like to say again -- we have started very well the 2025. We have a growth momentum that continues. We are on track to achieve our expectations and our guidance.

    謝謝你,莎倫。所以我想先感謝大家的關注和提出的精彩問題。最後,我想再說一次——我們已經為 2025 年做好了充分的準備。我們的成長勢頭仍在持續。我們正朝著實現我們的期望和指導的方向前進。

  • And importantly, we are entering a catalyst-rich period as we said many times before, by the end of this year or the next year, we'll have a very good sense for the driving factors for our growth to 2030.

    重要的是,正如我們之前多次說過的,我們正在進入一個催化劑豐富的時期,到今年年底或明年,我們將對 2030 年增長的驅動因素有非常好的認識。

  • So far, so good. We have five positive Phase III studies in particular, important ones like SERENA-6, MATTERHORN and of course, more recently, DB09. We've had 13, 1-3, regulatory approvals across the major regions in the quarter. Our revenue is up 10% and very much on track with what we expect. Our expenses are well managed, and I know there's been a focus on SG&A.

    到目前為止,一切都很好。我們有五項特別積極的 III 期研究,其中很重要的有 SERENA-6、MATTERHORN,當然還有最近的 DB09。本季度,我們已獲得各主要地區 13 個監管部門的批准。我們的收入成長了 10%,與我們的預期非常一致。我們的開支管理得很好,我知道我們一直在關注銷售、一般和行政費用。

  • So I'd like to attract your attention that SG&A grew by 5% even though we have many launches. So everybody is really working hard to manage those launches and control SG&A growth. And as a result, our operating profit is up -- sorry, 12% and our EPS 21%.

    因此我想提請大家注意,儘管我們有許多新產品推出,但銷售、一般及行政開支 (SG&A) 仍成長了 5%。因此,每個人都在努力管理這些產品的發布並控制銷售、一般和行政費用的成長。因此,我們的營業利潤上漲了——抱歉,是 12%,每股收益上漲了 21%。

  • So that really is a series of messages I wanted to leave you with because, again, we are very much on track. So with that, thank you so much again, and I wish you a good rest of the day.

    所以這確實是我想留給你們的一系列訊息,因為我們現在正處於正確的軌道上。所以,再次感謝您,並祝您今天過得愉快。