AstraZeneca PLC (AZN) 2025 Q4 法說會逐字稿

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  • Andy Barnett - Head of Investor Relations

    Andy Barnett - Head of Investor Relations

  • All right. A warm welcome, everybody, to AstraZeneca's full year fourth 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 the rest of the executive team, I'd like to cover some housekeeping items.

    好的。熱烈歡迎各位參加阿斯特捷利康2025年第四季全年業績發表會電話會議和網路直播,本次會議面向投資者和分析師。我是投資者關係主管安迪·巴內特。在將發言權交給帕斯卡爾和其他高階主管團隊之前,我想先處理一些事務性事項。

  • Firstly, all the materials presented today are already available on the AstraZeneca Investor Relations website. Next slide, please. This slide contains our forward-looking statements, including the safe harbor provisions, which I'd encourage you to take the time to read. We would 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 and all numbers quoted today are in millions of US dollars unless stated otherwise.

    首先,今天展示的所有資料都已在阿斯特捷利康投資者關係網站上提供。請看下一張投影片。本投影片包含我們的前瞻性聲明,包括安全港條款,我建議您花時間閱讀。我們將使用固定匯率(CER)、核心財務資料和其他非公認會計準則(non-GAAP)指標對我們的績效發表評論。業績公告中包含非GAAP與GAAP的調整表,除非另有說明,今天引用的所有數字均以百萬美元為單位。

  • Next slide, please. Here's the agenda for today's call. Following our prepared remarks, as usual, we'll open the line for questions. We will try and address as many questions as we can during the allocated time or to please limit the number of questions you ask set to allow others a fair chance to participate. We do have a hard stop today at quarter past the hour as many of us have to catch flights in order to participate in the full year roadshow. So we will need to cut it short. We'll try and get to as many people as we can. Hopefully, everybody gets a clear chance to ask a question.

    請看下一張投影片。以下是今天電話會議的議程。照例,在發言結束後,我們將開放提問環節。我們將在規定的時間內盡可能回答問題,或請您限制提問的數量,以便其他人也有公平的參與機會。今天我們整點一刻就必須結束,因為我們中的許多人都要趕飛機才能參加全年的巡迴活動。所以我們需要縮短時間。我們會盡力聯繫到盡可能多的人。希望每個人都有機會提問。

  • And with that, Pascal, great year. Over to you.

    帕斯卡,就這樣,你度過了精彩的一年。接下來該你了。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Andy. Welcome, everyone. It's really a great pleasure to see you all again and to present our full year results. It's been a great year. A company -- if we can move to the next slide. The company delivered very strong performance, both on the financial and most importantly, the pipeline front. On the financial side, revenue grew 8% and product revenue importantly grew 10% driven by continued global demand for our innovative medicines.

    謝謝你,安迪。歡迎各位。非常高興再次見到大家,並向大家報告我們全年的工作成果。今年真是美好的一年。一家公司——如果我們能進入下一張幻燈片的話。公司業績表現非常強勁,無論是在財務方面,或是最重要的專案儲備方面。在財務方面,收入成長了 8%,產品收入更是成長了 10%,這主要得益於全球對我們創新藥物的持續需求。

  • Our core EPS, as you can see here, grew by 11%. We had 16 blockbuster medicines in 2025, with 17 of those growing at double digits -- with 17 medicines, sorry, growing at double digit. And we have the potential to get to 25 blockbusters by 2030. Remember, when we announced our $80 billion target back in May 2024, we had 12 blockbusters at the time. We now have 16 and we hope to get 25. And many of those new ones actually are either approved or soon approved or in Phase III. So good hopes that we will indeed get to 25.

    如您所見,我們的核心每股收益成長了 11%。到 2025 年,我們將有 16 種重磅藥物,其中 17 種藥物的增長速度將達到兩位數——抱歉,是 17 種藥物的增長速度將達到兩位數。到 2030 年,我們有潛力推出 25 部票房大片。請記住,當我們在 2024 年 5 月宣布 800 億美元的目標時,我們當時有 12 部重磅影片。我們現在有16個,希望能夠達到25個。而且其中許多新藥實際上已經獲得批准、即將獲得批准或進入第三期臨床試驗。所以,真心希望我們能夠達到25。

  • At our full year results last year, we signaled that we are entering an unprecedented catalyst switch period for our company. Our R&D teams continue to deliver. We had 16 positive Phase III trial readouts in 2025. Together, they have a combined pick-year sales potential of $10 billion, as you see on this slide. In the last 12 months, we have secured 43 approvals for our medicines across major regions, helping us to sustain growth into 2026.

    在去年的全年業績報告中,我們宣佈公司即將進入一個前所未有的催化劑轉換期。我們的研發團隊持續取得成果。2025年,我們有16項積極的III期臨床試驗結果公佈。如您在這張投影片中看到的那樣,它們加起來的年度銷售潛力總計達 100 億美元。在過去的 12 個月裡,我們的藥品在主要地區獲得了 43 項批准,這有助於我們保持成長勢頭直至 2026 年。

  • And it's important also for me to recognize the work everybody has done in the company as far as the company to do this, in particular, our global operations colleagues, because each time we launch one product, for them it's probably 50, 60 launches, so many different SKUs around the world. So everybody has done a tremendous job across the organization.

    同時,我也要感謝公司裡每個人為實現這一目標所做的工作,特別是我們的全球營運同事,因為每次我們推出一款產品,對他們來說可能意味著 50、60 次發布,全球範圍內有如此多的不同 SKU。所以整個組織裡的每個人都做得非常好。

  • So if we move to the next slide. The strength of our portfolio is really -- was clear in 2025. And we are not taking significant steps to continue to strengthen our manufacturing and R&D footprint in both the U.S. and China. Together, our global reach and our diverse revenue streams really support our low concentration risk and ensure resilience to regional disruptions. But one to keep in mind, I know a couple of years ago, many questions we were getting where your pipeline is complicated, it's diversified. I struggled to get my head around it. I hope today, people realize better the value of this diversification.

    那麼,如果我們切換到下一張投影片。我們的投資組合實力確實很強──這一點在2025年就顯而易見了。我們並沒有採取實質措施來繼續加強我們在美國和中國的製造和研發局。我們的全球佈局和多元化的收入來源共同支撐了我們較低的風險集中度,並確保了我們抵禦區域性幹擾的能力。但有一點要記住,我知道幾年前,我們收到很多關於管道複雜、多樣化的問題。我費了好大勁才理解這件事。我希望今天人們能更能體認到這種多元化經營的價值。

  • We're now talking about concentration risk. It's great to have one or two big, big products, makes you very, very profitable and make you look good. But one of those, if you lose one of those as we've seen happen to some actors in the industry lately, it really becomes very painful very quickly. So this diversification, both product-wise but also geographically, is certainly becoming more apparent as we drive growth through therapy areas, but also through regions.

    我們現在討論的是集中風險。擁有一兩款大牌產品當然很好,能讓你賺很多錢,也能讓你看起來很厲害。但是,如果你失去了其中之一,就像我們最近在業內一些演員身上看到的那樣,那真的會很快變得非常痛苦。因此,這種產品多元化以及地理多元化,隨著我們透過治療領域和地區推動成長,無疑變得越來越明顯。

  • So if you look at this chart, we saw growth across oncology and R&I in particular, growing each 17% and 12%, respectively. CVRM, of course, was impacted by the patent expiry of Brilinta and Farxiga in the UK and there will be more of this, unfortunately, in 2026. Despite this, we still grew 2%. And overall, biopharmaceuticals still grow 6% and represents about 40% of our global sales.

    所以,如果你看一下這張圖表,我們看到腫瘤學和研發領域尤其實現了成長,分別成長了 17% 和 12%。當然,CVRM 受到了 Brilinta 和 Farxiga 在英國專利到期的影響,不幸的是,2026 年還會出現更多這種情況。儘管如此,我們仍然實現了 2% 的成長。整體而言,生物製藥業務仍維持 6% 的成長,約占我們全球銷售額的 40%。

  • Rare disease grew 5% despite the impact of biosimilars on Soliris. I would say the transition from Soliris to Ultomiris is not totally finished, but close to being completed and Ultomiris is now growing very nicely. We continue to see increasing demand for our medicines across all our regions. Of course, growth -- strong growth in the US, 10%. We continue to grow in Europe.

    儘管生物相似藥對 Soliris 產生了影響,但罕見疾病仍增加了 5%。我認為從 Soliris 到 Ultomiris 的過渡還沒有完全完成,但已經接近完成,而且 Ultomiris 現在發展得非常好。我們看到,在我們所有地區,對我們藥品的需求都在持續成長。當然,成長——美國強勁成長,達到 10%。我們在歐洲持續發展壯大。

  • But importantly, I think I would like to highlight, attract your attention to the emerging markets outside of China. China still grew 4% despite losing Pulmicort to generics. We still grew 4%, which is quite nice, and we remain the largest pharma company in China. But outside of China, 22%. This part of the world is starting to really play an important role. As I said, Europe, we still grow 7%.

    但更重要的是,我想強調,請大家關注中國以外的新興市場。儘管普米克汀(Pulmicort)被仿製藥取代,中國經濟仍成長了4%。我們仍然實現了 4% 的成長,這相當不錯,而且我們仍然是中國最大的製藥公司。但在中國以外,這一比例為 22%。世界這一地區正開始發揮越來越重要的作用。正如我所說,歐洲,我們仍然保持著7%的成長率。

  • Next slide, please. Importantly, our momentum through the pipeline continues. We now have more than 100 Phase III trials that are ongoing. Think about that, 100 Phase III trials. It's an enormous momentum going through the pipeline. And this year, we should have 20 Phase III readouts. And those readouts, fingers crossed, of course, if they are positive, they will collectively drive another more than $10 billion of peak revenue. And the pipeline '27 should also, again, deliver a similar number, actually slightly higher in 2027. Of course, not all, but at least the great majority of these Phase III readouts need to be positive.

    請看下一張投影片。重要的是,我們在管道建設方面保持著強勁勢頭。我們目前有超過100項三期臨床試驗正在進行中。想想看,這可是 100 項 III 期臨床試驗啊。這是一股正在管道中蓬勃發展的巨大勢頭。今年,我們應該會有 20 個 III 期臨床試驗結果公佈。當然,如果這些讀數是正面的,我們衷心希望如此,它們將共同推動超過 100 億美元的高峰收入。2027 年的管道項目也應該會再次交付類似的數量,實際上 2027 年的數量還會略高一些。當然,並非全部,但至少絕大多數 III 期試驗結果需要為陽性。

  • Importantly, you can see that there's the growing number of late-stage assets, but importantly, an increasing value per indication. As our pipeline grows, we continue to focus and prioritize. And of course, we prioritize the most valuable projects. And you can see in light pink, the average peak-year revenue per indication. That reflects the increasing individual value of projects and continuous effort we make to prioritize even though we have a lot of projects.

    重要的是,你可以看到後期資產的數量在增加,但更重要的是,每個適應症的價值也在增加。隨著我們的業務拓展,我們將繼續集中精力並確定優先事項。當然,我們會優先考慮最有價值的項目。圖中淺粉紅色部分顯示的是各指標的平均高峰年份收入。這反映了專案個人價值的不斷提升,以及我們即使有許多專案也要持續努力進行優先排序。

  • Next slide, please. So the question is often asked of us beyond 2030. And we said back in May 2024 and we continue saying the same. We want to be a growth company until 2030, reached this $80 billion ambition, but also be a growth company post 2030. And that is why we need to continue investing in R&D. That is why we need to continue focusing on technologies, new medicines that will actually change the future of medicines and drive our growth post 2030.

    請看下一張投影片。因此,人們常常問我們2030年後會怎樣。我們在 2024 年 5 月就說過,我們現在仍然這麼說。我們希望在 2030 年前保持成長,並實現了 800 億美元的目標,但也要在 2030 年後繼續保持成長。所以,這就是為什麼我們需要繼續加大研發投入。這就是為什麼我們需要繼續專注於科技和新藥,這些科技將真正改變醫藥的未來,並推動我們在 2030 年後的成長。

  • So you can see here the list of the five technologies that we prioritize and decided to invest in. And if you look at weight management, cardiovascular risk factors, we now have two products in Phase III, of course, are all PCSK9, for which we will get data in 2027. But we also announced that we have moved our oGLP-1 into Phase III, and we have a broad set of studies covering diabetes, weight loss in monotherapy, combination products, cardiovascular outcome studies. So we have a very ambitious plan for our oGLP-1.

    所以您可以在這裡看到我們優先考慮並決定投資的五項技術清單。如果你看看體重管理、心血管風險因素,我們現在有兩款產品處於 III 期臨床試驗階段,當然,它們都是 PCSK9 抑制劑,我們將在 2027 年獲得相關數據。但我們也宣布,我們的 oGLP-1 已進入 III 期臨床試驗,並且我們進行了一系列廣泛的研究,涵蓋糖尿病、單藥治療的減肥、聯合用藥、心血管結果研究。所以我們為 oGLP-1 制定了一個非常雄心勃勃的計劃。

  • But beyond this, we're also investing in new products that will actually shape the future of this weight management sector, which is in the initial steps really. And the future will be made of better convenience, longer duration of action for injectables moving to weekly to monthly. And -- some of this will come from the partnership we announced with CSPC recently, but also new mechanisms. So we are waiting for data on our GLP-1/glucagon and amylin product. The GLP-1/glucagon in itself has independent value, but we also will combine it with amylin. So we should get data this year. So oral agents, long-acting injectables, new mechanisms, helping patients lose more fat and less muscle are the directions we are heading into.

    但除此之外,我們還在投資研發新產品,這些產品將真正塑造體重管理產業的未來,而這個產業目前還處於起步階段。未來將更加便捷,注射劑的作用時間更長,注射頻率也將從每週一次改為每月一次。其中一部分將來自我們最近宣布與 CSPC 建立的合作關係,但也包括新的機制。所以我們正在等待 GLP-1/胰高血糖素和胰淀素產品的相關數據。GLP-1/胰高血糖素本身俱有獨立的價值,但我們也會將其與胰淀素結合使用。所以今年我們應該可以拿到數據。因此,口服藥物、長效注射、新機制,以及幫助患者減少更多脂肪和更少肌肉,是我們努力的方向。

  • Now if you look at ADC and Radioconjugates, we now have 8 ADCs that are ADCs that came out of our own pipeline, our own efforts. Three of those are in Phase III. We will get data in the first half of this year for one of those, as you can see here, sone-ve. And importantly, we have new ones, both as ADCs, but also radioconjugates that are moving through early development. We have novel linker combinations, payload combinations. We have dual payload ADC. We have radioligands. So we continue to build this, that will drive our growth post 2030.

    現在,如果你看看 ADC 和放射性偶聯物,我們現在有 8 種 ADC,它們都是我們自己研發、自己努力的成果。其中三個處於第三階段。我們將在今年上半年獲得其中一個(如您在此處看到的)的數據。更重要的是,我們有了新的藥物,包括抗體藥物偶聯物(ADC)和放射性偶聯物,它們正處於早期研發階段。我們擁有新穎的連接子組合和有效載荷組合。我們採用雙有效載荷ADC。我們有放射性配體。因此,我們將繼續推進這項策略,這將推動我們在 2030 年以後的成長。

  • We, of course, invest in our next-generation IO bispecifics, in particular, rilvegostomig. And we combine those with our ADCs, as we've said in the past. Cell therapy, T-cell engagers, we're making good progress with AZD0120 that has good encouraging data in Phase I, but is entering Phase III this year. And we are moving as fast as we can to move it into hematology indications, but also immunology indications. And we also have very exciting data, early data for surovatamig, and it's also moving into Phase III.

    我們當然會投資我們的下一代 IO 雙專用處理器,特別是 rilvegostomig。正如我們之前所說,我們會將這些與我們的ADC結合起來。細胞療法、T 細胞銜接器,我們在 AZD0120 方面取得了良好進展,該藥物在 I 期臨床試驗中獲得了令人鼓舞的數據,但今年將進入 III 期臨床試驗。我們正在盡最大努力,盡快將其推廣到血液學領域,以及免疫學領域。我們還有一些非常令人興奮的數據,surovatamig 的早期數據,它也正在進入 III 期臨床試驗。

  • And on top of this, we have multiple approaches to CAR-T, not only CAR-T, but also allogeneic projects that some of them will be in the clinic this year. And we're working on the in vivo approach, as you know. And then we also have new platforms, TCE platforms. And finally, we're making progress also in our gene therapy programs.

    除此之外,我們還有多種 CAR-T 療法,不僅是 CAR-T 療法,還有同種異體療法項目,其中一些項目將於今年進入臨床試驗階段。如您所知,我們正在研究體內實驗方法。此外,我們還有新的平台,即 TCE 平台。最後,我們的基因治療計畫也取得了進展。

  • So if we move to the next one, I'll hand out to Aradhana, who will take you through the financials. Thank you.

    接下來,我將把麥克風交給 Aradhana,她將為大家講解財務部分。謝謝。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Thank you, Pascal, and good afternoon, everyone, and good morning to our colleagues in the US who woke up very early to join us. So as usual, I'll start with our reported P&L.

    謝謝帕斯卡爾,大家下午好,也向早起加入我們的美國同事們問好。那麼,照例,我先從我們公佈的損益表開始。

  • Next slide, please. Total revenue increased 8% in 2025. Product revenue, which consists of product sales and alliance revenue increased 10% with continued growth across all key regions. Alliance revenue increased by 38%, reflecting increased contribution from our share of profits with partnered products such as Enhertu, Tezspire, and Beyfortus in regions where our partners book product sales.

    請看下一張投影片。2025年總營收成長8%。產品收入(包括產品銷售和聯盟收入)成長了 10%,所有主要地區均持續成長。聯盟收入成長了 38%,這反映出我們在合作夥伴銷售產品(例如 Enhertu、Tezspire 和 Beyfortus)的地區所獲得的利潤份額增加。

  • Next slide, please. This is our core P&L. The core gross margin landed at 82% in 2025, in line with expectations set out at the start of the year. Fourth quarter gross margin reflected the normal seasonal pattern as well as $235 million of royalty buyouts for Saphnelo and rilvegostomig, which were recorded in the cost of sales. Core R&D expenses increased by 12%, reflecting the growing number of investment opportunities in our broad and deep pipeline. At the end of 2025, we had more than 300 active trials, and as Pascal mentioned, more than 100 of these in Phase III.

    請看下一張投影片。這是我們的核心損益表。2025 年核心毛利率達 82%,與年初設定的預期一致。第四季毛利率反映了正常的季節性模式,以及對 Saphnelo 和 rilvegostomig 的 2.35 億美元特許權收購,這些收購計入了銷售成本。核心研發費用增加了 12%,反映出我們廣泛而深入的產品線中投資機會的不斷增加。到 2025 年底,我們有 300 多項正在進行的試驗,正如 Pascal 所提到的,其中 100 多項處於 III 期。

  • SG&A expenses increased by only 3% in 2025, reflecting continued cost discipline and focus on operating leverage. We continue to streamline our business, and as a proportion of total revenue, SG&A expenses decreased from 28% in 2024 to 26% in 2025. Operating profit increased by 9% with operating leverage continuing to be a key focus for the company. We manage our P&L in totality, enabling flexibility and investment decisions throughout the year. The lower tax rate seen in the fourth quarter reflected a release of certain tax provisions taken in prior years. Core EPS increased by 11%, in line with our full year guidance.

    2025 年銷售、一般及行政費用僅成長 3%,反映出持續的成本控制和對營運槓桿的關注。我們持續精簡業務,銷售、一般及行政費用佔總收入的比例從 2024 年的 28% 下降到 2025 年的 26%。營業利潤成長了 9%,經營槓桿仍然是公司的重點領域。我們對損益進行全面管理,以便在全年都能靈活地做出投資決策。第四季較低的稅率反映了前幾年提列的某些稅收準備金的釋放。核心每股收益成長11%,與全年預期一致。

  • Next slide, please. We continue to see strong cash flow from operating activities, which increased by 23% to $14.6 billion in 2025. We saw CapEx increasing by $1.1 billion to $3.3 billion, in line with the expectations set out at the beginning of the year. For 2026, we anticipate CapEx investment to increase by approximately one-third versus 2025 as we expand capacity to support future growth. This includes our recently announced US and China investments and previously announced investments in our ADC facility in Singapore, all of which are multiyear projects.

    請看下一張投影片。我們繼續看到來自經營活動的強勁現金流,預計到 2025 年將成長 23%,達到 146 億美元。我們看到資本支出增加了 11 億美元,達到 33 億美元,與年初設定的預期一致。預計 2026 年資本支出投資將比 2025 年增加約三分之一,因為我們將擴大產能以支持未來的成長。這包括我們最近宣布的在美國和中國的投資,以及先前宣布的新加坡ADC工廠的投資,所有這些都是多年期項目。

  • Total deal payments in 2025 amounted to $4.2 billion, of which around $3 billion were payments relating to past deals and the remaining were payments for deals announced in 2025 such as EsoBiotec.

    2025 年的總交易付款額為 42 億美元,其中約 30 億美元是與過去交易相關的付款,其餘部分是 2025 年宣布的交易的付款,例如 EsoBiotec。

  • In 2026, we anticipate success-based milestones and sales payments relating to past deals to total around $2.5 billion. Our capital allocation priorities remain unchanged. We currently have interest-bearing debt of close to $30 billion, which is a level we're comfortable with as we continue making investments to drive future growth, expand our supply chain globally and further strengthen our R&D pipeline. Our net debt-to-EBITDA ratio currently sits at 1.2 times.

    預計到 2026 年,基於成功里程碑的付款和與過去交易相關的銷售付款總額將達到約 25 億美元。我們的資本配置優先事項保持不變。我們目前的計息債務接近 300 億美元,我們認為這個水準是可以接受的,因為我們將繼續進行投資以推動未來的成長,擴大我們的全球供應鏈,並進一步加強我們的研發管道。我們目前的淨債務與 EBITDA 比率為 1.2 倍。

  • Today, we are pleased to confirm a second interim dividend of $2.17 per share, resulting in a full year 2025 declared dividend of $3.20 per share. In 2026, we intend to increase the annual declared dividend to $3.30 per share, in line with our progressive dividend policy. Today, we also issue our 2026 guidance. As usual, our full year guidance is at constant exchange rates. We anticipate total revenue to grow by a mid- to high single-digit percentage, driven by strong underlying momentum in the business.

    今天,我們很高興地確認派發第二期中期股息,每股 2.17 美元,使得 2025 年全年宣布派發的股息達到每股 3.20 美元。2026年,我們計劃將年度宣布股利提高至每股3.30美元,符合我們漸進式股利政策。今天,我們也發布了 2026 年的業績指引。與往常一樣,我們的全年業績指引是按固定匯率計算的。我們預計總收入將實現中高個位數百分比的成長,這主要得益於業務強勁的潛在成長勢頭。

  • The growth will be delivered despite known headwinds in 2026, including VBP in China this quarter for Farxiga, Lynparza and roxadustat. Farxiga will also face loss of exclusivity in the US in April. In 2025, US Farxiga generated $1.7 billion or 21% of global revenues, while China represented just under half of emerging markets revenue. In Europe, which accounts for 35% of Farxiga total revenue, patent protections across EU markets extend to 2028. While the MFN deal presents a headwind in 2026, the effect is already factored in our guidance and can be absorbed given our large and growing revenue base.

    儘管 2026 年面臨許多不利因素,包括本季在中國對 Farxiga、Lynparza 和 roxadustat 的 VBP 影響,但成長仍將實現。Farxiga 將於 4 月失去在美國的獨家銷售權。2025 年,美國 Farxiga 創造了 17 億美元,佔全球收入的 21%,而中國則佔新興市場收入的近一半。在歐洲,Farxiga 的總收入中有 35% 來自歐洲,在歐盟市場的專利保護期至 2028 年。雖然最惠國待遇協議在 2026 年會帶來不利影響,但鑑於我們龐大且不斷增長的收入基礎,這種影響已經反映在我們的預期中,並且可以被吸收。

  • Despite these headwinds, we anticipate a broadly flat to slightly higher core gross margin in 2026 driven by backing out the royalty buyout and product sales mix. We expect a core tax rate between 18% and 22% in 2026 and core EPS growth of low double-digit percentage at constant exchange rates. Based on January average exchange rates, we anticipate a low single-digit positive FX impact on total revenue and neutral impact on core EPS.

    儘管面臨這些不利因素,但我們預計,在剔除特許權使用費收購和產品銷售組合的影響後,2026 年核心毛利率將基本持平或略有上升。我們預計 2026 年核心稅率在 18% 至 22% 之間,以固定匯率計算,核心每股盈餘成長率將達到兩位數百分比。根據 1 月的平均匯率,我們預期匯率波動將對總收入產生個位數的正面影響,對核心每股盈餘產生中性影響。

  • Next slide, please. As I mentioned earlier, we continue to make significant R&D investments in emerging areas such as ADCs, cell therapy, bispecific and late-state CVRM portfolio which have the potential to drive growth beyond 2030. As a result, we anticipate R&D expenses to be at the upper end of the low 20s percentage range of total revenue in 2026.

    請看下一張投影片。正如我之前提到的,我們將繼續在 ADC、細胞療法、雙特異性抗體和後期 CVRM 產品組合等新興領域進行大量研發投資,這些領域有可能推動 2030 年以後的成長。因此,我們預計到 2026 年,研發費用將達到總收入的 20% 左右。

  • SG&A as a percentage of total revenue has continued to decline over recent years, reflecting our disciplined approach to efficiency and operating leverage. At the same time, we're making targeted investment to support the next wave of growth with several important NME launches ahead of us, including baxdrostat, camizestrant and gefurulimab, all of which are medicines with blockbuster potential.

    近年來,銷售、一般及行政費用佔總收入的比例持續下降,這反映了我們為提高效率和營運槓桿而採取的嚴謹方法。同時,我們正在進行有針對性的投資,以支持下一波成長,我們即將推出幾款重要的 NME,包括 baxdrostat、camizestrant 和 gefurulimab,所有這些藥物都具有成為重磅炸彈的潛力。

  • While we continue to target a mid-30s operating margin in 2026, our priority remains to drive absolute profit growth and long-term value for our shareholders. As highlighted earlier, we remain comfortable with our current level of gross debt, we anticipate a step-up in core net finance expense for 2026 driven by higher lease expenses and lower interest income. In summary, we saw a very strong financial performance in 2025 which we anticipate to continue in 2026.

    儘管我們仍以 2026 年實現 30% 左右的營業利潤率為目標,但我們的首要任務仍然是推動絕對利潤成長,並為股東創造長期價值。如前所述,我們對目前的債務總額水準感到滿意,但預計 2026 年核心淨融資費用將因租賃費用增加和利息收入減少而上升。總而言之,我們在 2025 年看到了非常強勁的財務業績,我們預計 2026 年將繼續保持這一勢頭。

  • Next slide, please. With that, I will hand over to Dave, who will take you through the commercial performance of our oncology business.

    請看下一張投影片。接下來,我將把麥克風交給戴夫,他將為大家介紹我們腫瘤業務的商業表現。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thank you, Aradhana. Next slide, please. In 2025, Oncology delivered total revenues of $25.6 billion, an increase of 14% on the prior year or 17% excluding the 2024 Lynparza sales milestone. Many of our key medicines have surpassed notable multi-blockbuster milestones with Tagrisso achieving over $7 billion in full year revenues, Imfinzi over $6 billion, Calquence over $3.5 billion and Enhertu over $2.5 billion in AZ revenues.

    謝謝你,阿拉德哈娜。請看下一張投影片。2025 年,腫瘤業務總收入達到 256 億美元,比上一年增長 14%,如果排除 2024 年 Lynparza 的銷售里程碑,則增長 17%。我們許多關鍵藥物都取得了顯著的多重磅里程碑式的成就,其中 Tagrisso 的全年收入超過 70 億美元,Imfinzi 超過 60 億美元,Calquence 超過 35 億美元,Enhertu 超過 25 億美元。

  • This performance is a tangible demonstration of our commitment to bringing medicines with transformative potential to patients globally and is particularly notable given the headwinds from the introduction of the 20% manufacturers liability under Medicare Part D reform from last year.

    這項績效切實證明了我們致力於為全球患者帶來具有變革潛力的藥物的承諾,考慮到去年醫療保險D部分改革引入的20%製造商責任帶來的不利影響,這一業績尤其值得關注。

  • Turning now to our fourth quarter performance. Total revenues exceeded $7 billion for the first time, up 20% on the year, excluding the Lynparza milestone with all our key medicines in regions demonstrating double-digit growth. Tagrisso global revenues were up 10%, reflecting continued demand growth across all indications. In the first-line setting, we are now seeing a significant proportion of patients receiving a combination regimen. With FLAURA-2 being the clear preference across key markets. In earlier lines, increased adoption of ADAURA and LAURA has been another meaningful source of growth.

    現在來看我們第四季的業績。總收入首次超過 70 億美元,年增 20%(不包括 Lynparza 的里程碑式成長),我們所有主要藥物在各地區的銷售額均實現了兩位數成長。Tagrisso全球營收成長10%,反映出所有適應症的需求持續成長。在第一線治療中,我們現在看到相當一部分患者接受聯合治療方案。FLAURA-2 在主要市場中明顯更受歡迎。在此之前,ADAURA 和 LAURA 的日益普及是另一個重要的成長來源。

  • Imfinzi and Imjudo delivered 37% and 26% growth, respectively, reflecting continued demand across tumor types. This growth is broad-based from both continued expansion of newer indications such as ADRIATIC in small cell lung cancer and NIAGARA in bladder cancer as well as increased uptake of more established indications such as HIMALAYA in liver cancer.

    Imfinzi 和 Imjudo 分別達到了 37% 和 26% 的成長,反映出各種腫瘤類型對藥物的持續需求。這一增長基礎廣泛,既得益於 ADRIATIC 用於小細胞肺癌、NIAGARA 用於膀胱癌等新適應症的持續擴展,也得益於 HIMALAYA 用於肝癌等更成熟適應症的日益普及。

  • Calquence total revenues increased 17% in the fourth quarter, driven by additional demand in frontline CLL as we maintain our class leadership position across major markets. Specifically, in the United States, we've seen our market share leadership grow over the course of the year, demonstrating our competitive positioning and differentiation.

    由於我們在主要市場保持了領先地位,一線 CLL 治療需求增加,Calquence 在第四季度總收入增加了 17%。具體來說,在美國,我們看到我們的市佔率領先地位在過去一年中不斷增長,這證明了我們的競爭地位和差異化優勢。

  • Enhertu delivered total revenue growth of 46% in the fourth quarter. Across all regions, Enhertu is seeing share gains both in HER2-positive and HER2 low metastatic breast cancer. And in China, demand continues to increase following NRDL enlistment in January of last year.

    Enhertu第四季總營收成長46%。在所有地區,Enhertu 在 HER2 陽性和 HER2 低轉移性乳癌領域均取得了市場份額的成長。在中國,自去年1月NRDL招募以來,需求持續成長。

  • Truqap revenues grew 41% in the fourth quarter with year-over-year comparisons benefiting from both inventory build in the US and the reversal of pricing accruals in Europe. In the US, we now believe Truqap is at peak with further incremental growth to be driven by other markets. Finally, Datroway revenues of $40 million in the fourth quarter reflect our early launch momentum in late line EGFR mutated lung cancer, including an emerging leadership position in the third line.

    Truqap 第四季營收成長 41%,年成長得益於美國庫存增加和歐洲價格調整的逆轉。我們認為,Truqap 在美國的市佔率已達到頂峰,未來將由其他市場推動進一步成長。最後,Datroway 第四季的收入為 4000 萬美元,反映了我們在晚期 EGFR 突變肺癌的早期上市勢頭,包括在三線治療領域嶄露頭角的領導地位。

  • Next slide, please. The strong momentum in 2025 continues into 2026. For Imfinzi, we were pleased to see the US approval for MATTERHORN in early gastric cancer at the end of November and are already seeing encouraging uptake. POTOMAC in bladder cancer will add another growth opportunity this year with the first approval expected in the first half. We expect data in 2026 for several Imfinzi combinations, including Imjudo in bladder cancer, and HCC and with Datroway in lung, with commercial launches planned in 2027, pending, of course, positive results and regulatory approvals.

    請看下一張投影片。2025年的強勁勢頭延續到了2026年。對於 Imfinzi 而言,我們很高興看到 MATTERHORN 在 11 月底獲得美國批准用於治療早期胃癌,並且已經看到令人鼓舞的市場接受度。POTOMAC 在膀胱癌領域今年將迎來另一個成長機遇,預計上半年將獲得首個批准。我們預計在 2026 年將獲得幾種 Imfinzi 聯合療法的數據,包括 Imjudo 用於膀胱癌和肝細胞癌,以及與 Datroway 用於肺癌,併計劃在 2027 年進行商業推廣,當然,前提是獲得積極的結果和監管部門的批准。

  • 2026 is set to be another landmark year for Enhertu as we further expand our position as the standard of care in HER2-positive breast cancer by bringing this transformational medicine to three new settings. This includes the first-line metastatic setting following the recent approval of DESTINY-Breast09, with approvals in early breast cancer for DESTINY-Breast11 and DB05 also expected this year. Looking to 2027 and beyond, we remain focused on bringing Enhertu to more patients globally, including in settings beyond breast cancer, such as lung cancer.

    2026 年將是 Enhertu 的另一個里程碑之年,我們將把這種變革性藥物引入三個新的領域,進一步鞏固我們在 HER2 陽性乳癌治療領域的標準地位。這包括 DESTINY-Breast09 最近獲準用於第一線轉移性治療,預計今年 DESTINY-Breast11 和 DB05 也將獲準用於早期乳癌治療。展望 2027 年及以後,我們將繼續致力於讓全球更多患者受益於 Enhertu,包括乳癌以外的其他疾病,例如肺癌。

  • For Calquence, we expect the imminent US launch of the AMPLIFY finite therapy regimen to be an important driver of growth for the year. This complements the sustained demand in the treat to progression segment within first-line CLL, where Calquence remains the leading BTKi inhibitor. Looking ahead, we aim to leverage our broader hematology portfolio to improve outcomes through combination approaches in CLL as well as in other hematologic malignancies.

    對 Calquence 而言,我們預計 AMPLIFY 有限療法方案即將在美國上市,這將成為今年成長的重要驅動力。這與一線 CLL 治療進展階段的持續需求相輔相成,Calquence 仍然是該領域領先的 BTKi 抑制劑。展望未來,我們的目標是利用我們更廣泛的血液疾病產品組合,透過聯合療法改善 CLL 以及其他血液惡性腫瘤的治療效果。

  • Building on double-digit growth for Tagrisso in 2025, we anticipate strong performance in 2026 driven by further adoption and geographic expansion of LAURA and ADAURA in early disease and sustained leadership in first-line metastatic disease, particularly within the growing combination market. Longer term, we look forward to the results of multiple combination trials that have the potential to reinforce Tagrisso as the backbone TKI, both in later lines with SAFFRON and TROPION-Lung15 and in the front line with TROPION-Lung14.

    2025 年 Tagrisso 實現了兩位數的成長,在此基礎上,我們預計 2026 年 Tagrisso 將取得強勁的業績,這主要得益於 LAURA 和 ADAURA 在早期疾病領域的進一步推廣和地域擴張,以及在一線轉移性疾病領域,尤其是在不斷增長的聯合治療市場中,Tagrisso 將繼續保持領先地位。從長遠來看,我們期待多項聯合試驗的結果,這些試驗有可能鞏固 Tagrisso 作為 TKI 骨幹的地位,無論是在後續治療中與 SAFFRON 和 TROPION-Lung15 聯合使用,還是在一線治療中與 TROPION-Lung14 聯合使用。

  • As we reflect on another strong year of growth, we continue to see sustained momentum in our oncology business heading into 2026. With a clear focus on expanding the reach of our medicines into new markets and with additional indications. With that, please advance to the next slide.

    回顧另一個強勁成長的年份,我們預計到 2026 年,我們的腫瘤業務將繼續保持持續成長勢頭。我們明確致力於將我們的藥品推廣到新的市場,並擴大其適應症。接下來,請進入下一張投影片。

  • I'll hand over to Susan, who will discuss our key readouts that we anticipate this year.

    接下來我將把發言權交給蘇珊,她將討論我們今年預期取得的關鍵數據。

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

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

  • Thank you, Dave. So momentum continues to build across our oncology portfolio. And as we enter 2026 with a robust pipeline, we have an important opportunity to advance therapies for patients with high unmet needs. Today, I want to spotlight several key catalysts supporting our continued growth, starting with our TROP2 ADC Datroway. Last year, we saw Datroway demonstrate its profile as best-in-class TROP2 ADC with launches in HR-positive breast cancer and later line EGFR mutated lung cancer and with compelling data presented at ESMO in triple-negative breast cancer, demonstrating a five-month improvement in overall survival versus standard of care chemotherapy. TROPION-Breast02 has now been accepted by the FDA for priority review.

    謝謝你,戴夫。因此,我們在腫瘤產品組合方面的發展勢頭持續增強。隨著我們帶著強大的研發管線進入 2026 年,我們迎來了一個重要的機會,可以推進那些尚未得到充分滿足的患者的治療。今天,我想重點介紹幾個支持我們持續成長的關鍵催化劑,首先是我們的 TROP2 ADC Datroway。去年,我們看到 Datroway 憑藉其在 HR 陽性乳腺癌和後期 EGFR 突變肺癌中的上市,以及在 ESMO 上公佈的令人信服的三陰性乳腺癌數據,證明了其作為同類最佳 TROP2 ADC 的地位,數據顯示與標準治療化療相比,總生存期延長了五個月。TROPION-Breast02 現已被 FDA 接受優先審查。

  • This year, we expect the readout for AVANZAR, a pivotal trial evaluating Datroway as the first-line lung cancer setting. AVANZAR investigates the combination of Datroway with Imfinzi and carboplatin, aiming to deepen and extend responses for this large high unmet need population. Crucially, AVANZAR will be the first trial to validate our QCS TROP2-NMR biomarker designed to identify patients most likely to respond to Datroway in this first-line lung cancer setting. Success here could enable broader application of this technology in other tumor types and across our ADC portfolio.

    今年,我們期待 AVANZAR 試驗的結果,這是一項評估 Datroway 作為第一線肺癌治療藥物的關鍵性試驗。AVANZAR 研究 Datroway 與 Imfinzi 和卡鉑的聯合用藥,旨在加深和擴大對這一龐大且未滿足需求人群的療效。至關重要的是,AVANZAR 將是第一個驗證我們 QCS TROP2-NMR 生物標記的試驗,該生物標記旨在識別最有可能對 Datroway 一線肺癌治療產生反應的患者。如果這項技術取得成功,就能更廣泛地應用於其他腫瘤類型以及我們的 ADC 產品組合中。

  • Building on Datroway's current approval and later line EGFR mutated lung cancer, we also anticipate the readout from TROPION-Lung15, which evaluates Datroway alone or in combination with Tagrisso for patients who have progressed on a TKI. This trial aims to set new standards for second-line treatment, further reinforcing Tagrisso's role as the backbone of care in EGFR mutant lung cancer and paving the way for TROPION-Lung14 in first-line setting which can build on the success of FLAURA and FLAURA-2.

    基於 Datroway 目前獲準用於治療 EGFR 突變肺癌,我們也期待 TROPION-Lung15 的結果,該研究評估了 Datroway 單獨使用或與 Tagrisso 聯合用於 TKI 治療後病情進展的患者。該試驗旨在為二線治療設定新的標準,進一步鞏固 Tagrisso 作為 EGFR 突變肺癌治療支柱的作用,並為 TROPION-Lung14 在一線治療中鋪平道路,TROPION-Lung14 可以建立在 FLAURA 和 FLAURA-2 的成功之上。

  • Imfinzi continues to deliver transformative benefits across cancer types. And this year's key readouts in GI, lung and bladder cancer signal a third wave of Imfinzi growth highlighting the potential of combination regimens. I want to highlight two today. Firstly, the EMERALD-3 trial aims to bring the combination of Imfinzi and Imjudo into the local regional setting for hepatocellular carcinoma. Building on the transformative results we've already demonstrated in the later line HIMALAYA trial.

    Imfinzi持續為各種癌症類型帶來變革性的療效。今年胃腸道、肺癌和膀胱癌的關鍵數據表明,Imfinzi 迎來了第三波成長浪潮,凸顯了聯合治療方案的潛力。今天我想重點介紹兩點。首先,EMERALD-3 試驗旨在將 Imfinzi 和 Imjudo 的聯合療法引入肝細胞癌的局部區域治療中。基於我們在後續的 HIMALAYA 試驗中已經展現出的變革性成果。

  • Secondly, VOLGA looks to build on our existing presence in muscle invasive bladder cancer. The NIAGARA regimen established a role for Imfinzi as the first perioperative immunotherapy regimen in cisplatin eligible patients. VOLGA explores whether the combination of enfortumab vedotin and Imfinzi plus or minus Imjudo can improve outcomes for the 50% of patients that are not candidates for cisplatin.

    其次,VOLGA 希望鞏固我們在肌肉浸潤性膀胱癌領域的現有地位。NIAGARA 方案確立了 Imfinzi 作為順鉑適用患者圍手術期免疫治療方案的地位。VOLGA 研究探討了恩福妥單抗和 Imfinzi 聯合或不聯合 Imjudo 能否改善 50% 不適合接受順鉑治療的患者的治療結果。

  • This regimen is differentiated in two important ways. First, enfortumab vedotin is limited to the neoadjuvant setting, aiming to optimize outcomes while balancing the overall benefit risk profile. And secondly, acknowledge in bladder cancer sensitivity to CTLA-4 blockade, VOLGA's includes an arm delivering three cycles of Imjudo, two preoperatively and one postoperatively with the goal of further deepening responses in this patient population. In 2026, we will also see the second pivotal readout for camizestrant, next-generation oral SERD.

    此方案在兩個重要方面有所不同。首先,恩福妥單抗維多汀僅限於新輔助治療,旨在優化治療效果,同時平衡整體獲益風險。其次,考慮到膀胱癌對 CTLA-4 阻斷劑的敏感性,VOLGA 方案包括一個治療組,該治療組接受三個療程的 Imjudo 治療,兩個療程在術前,一個療程在術後​​,目的是進一步加深該患者群體的治療反應。2026 年,我們還將看到下一代口服 SERD 藥物 camizestrant 的第二個關鍵性結果。

  • Last year, we shared the first Phase III data for camizestrant in patients with first-line hormone receptor positive disease with emerging ESR1 mutations. The transformational SERENA-6 results demonstrated that intervening at the earliest opportunity and switching to a more effective endocrine option ahead of progression with camizestrant ahead of progression and the switching with camizestrant offers the chance to retain control of a patient's disease for longer and thereby realizes the full potential of first-line treatment.

    去年,我們分享了卡美司群治療第一線荷爾蒙受體陽性疾病且出現 ESR1 突變患者的首個 III 期臨床數據。SERENA-6 的變革性結果表明,儘早進行幹預,並在疾病進展前使用卡美司群(camizestrant)轉而使用更有效的內分泌治療方案,可以為患者提供更長時間的疾病控制,從而充分發揮一線治療的潛力。

  • In the second half of this year, SERENA-4 will read out, targeting a broader upfront first-line population eligible for the combination of a CDK4/6 inhibitor and an aromatase inhibitor and assessing whether camizestrant can replace the aromatase inhibitor to improve outcomes. Our confidence is driven not only by our data from the Phase II SERENA-2 and the Phase III SERENA-6 results, but also from recent readouts in the competitive space that demonstrate the value of this class in ESR1 wild type endocrine-sensitive disease.

    今年下半年,SERENA-4 研究將公佈結果,該研究針對更廣泛的一線治療人群,這些人群符合 CDK4/6 抑製劑和芳香化酶抑製劑聯合治療的條件,並評估卡美司群是否可以取代芳香化酶抑製劑以改善治療效果。我們的信心不僅來自 SERENA-2 II 期試驗和 SERENA-6 III 期試驗的結果,還來自競爭領域最近的試驗結果,這些結果證明了此類藥物在 ESR1 野生型內分泌敏感疾病中的價值。

  • Finally, progress is accelerating across our ADC portfolio with sone-ve Claudin18.2 targeted ADC on track to deliver its first Phase III data in second-line gastric cancer in the first half of the year. These six trials represent only a fraction of the opportunities of our oncology portfolio, which is poised to drive continued growth. And throughout the year, we'll continue to share updates from our early pipeline, reinforcing confidence in our -- in progress on our transformative technologies and therefore, long-term growth prospects through 2030 and beyond.

    最後,我們的 ADC 產品組合正在加速推進,其中靶向 Claudin18.2 的 ADC 預計將在今年上半年公佈其在二線胃癌治療中的首個 III 期數據。這六項試驗僅代表我們腫瘤產品組合中一小部分機會,而該產品組合有望推動持續成長。在這一年中,我們將繼續分享我們早期研發管線的最新進展,增強人們對我們正在進行的變革性技術的信心,從而增強人們對到 2030 年及以後長期增長前景的信心。

  • And with that, please advance to the next slide, and I'll pass over to Ruud to cover BioPharmaceuticals performance.

    那麼,請進入下一張投影片,接下來我將把發言權交給 Ruud,讓他介紹生物製藥產業的表現。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Thank you very much, Susan. Next slide, please. Our BioPharmaceuticals medicines delivered strong performance in 2025 with total revenue up 5% to $23 billion with our gross medicines substantially outpacing the impact of generic entry on a limited number of brands such as Brilinta in the United States and Europe and Farxiga in the United Kingdom.

    非常感謝你,蘇珊。請看下一張投影片。2025 年,我們的生物製藥業務表現強勁,總收入成長 5% 至 230 億美元,我們的藥品總收入大幅超過了仿製藥進入市場對少數品牌(如美國和歐洲的 Brilinta 以及英國的 Farxiga)的影響。

  • In the fourth quarter, R&I revenues were up by 10% with revenue from growth medicines having increased by 27%. CVRM revenues were 6% down on the prior year with generic competition slowing Farxiga's growth to 2% and Brilinta continuing to decline. V&I total revenue was down 33% year-on-year, largely due to the Beyfortus sales milestone booked in the fourth quarter of 2024.

    第四季度,研發收入成長了 10%,其中成長藥物的收入成長了 27%。CVRM 收入較上年下降 6%,仿製藥競爭導致 Farxiga 的成長放緩至 2%,而 Brilinta 則持續下滑。V&I 總營收年減 33%,這主要是由於 Beyfortus 的銷售里程碑在 2024 年第四季實現。

  • Next slide, please. Biologic medicines continue to gain share among severe asthma patients. Our medicines now make up more than half of the new-to-brand prescriptions for the severe asthma biologics segment in several markets. Fasenra is the leading IL-5 medicine for severe eosinophilic asthma and its product profile was recently strengthened with the launch of the EGPA indication. Overall, we expect Fasenra's positive momentum to continue in 2026, with growth in the emerging markets set to accelerate following inclusion in the national reimbursement drug list in China.

    請看下一張投影片。生物製劑在重症氣喘患者中的份額持續成長。在多個市場,我們的藥品目前佔重度氣喘生物製劑領域新處方藥的一半以上。Fasenra 是治療重度嗜酸性粒細胞性氣喘的領先 IL-5 藥物,最近隨著 EGPA 適應症的推出,其產品概況得到了加強。總體而言,我們預計 Fasenra 的積極勢頭將在 2026 年繼續保持,隨著其被納入中國國家醫保藥品目錄,新興市場的成長動能將加速。

  • Tezspire has made rapid market share gains in severe asthma since its launch and its growth potential has been enhanced by recent approvals for use in chronic rhinosinusitis with nasal polyps, where Tezspire has demonstrated that it can nearly eliminate the need for surgery. Nasal polyps are common comorbidity for asthma patients. So this approval further enhances its clinical profile.

    自上市以來,Tezspire 在重度氣喘領域迅速獲得了市場份額,並且最近獲準用於治療慢性鼻竇炎伴隨鼻息肉,進一步增強了其成長潛力。 Tezspire 已證明,它幾乎可以消除手術的必要性。鼻息肉是氣喘患者常見的合併症。因此,此次獲準進一步提升了其臨床應用價值。

  • Breztri is the fastest growing medicine within the expanding COPD. We are the clear market leader in China and have been gaining share in most other major markets. Additionally, regulatory reviews are underway for asthma based on the KALOS and LOGOS trials, and we anticipate first approvals in the first half of 2026.

    Breztri是COPD治療領域成長最快的藥物。我們在中國市場是絕對的領導者,並且在其他大多數主要市場也獲得了越來越多的份額。此外,基於 KALOS 和 LOGOS 試驗,氣喘藥物的監管審查正在進行中,我們預計將在 2026 年上半年獲得首批批准。

  • Saphnelo, biological medicine for the treatment of SLE is continuing to grow strongly with the IV formulation having gained market leadership in several major markets. Saphnelo subcutaneous formulation was recently approved in Europe and will extend its reach to the large segment of patients who favor self-administration. We are expecting further approvals of subcutaneous Saphnelo in other regions this year including in the United States and Japan in the first half.

    Saphnelo 是一種用於治療 SLE 的生物藥物,其靜脈注射製劑在幾個主要市場中佔據了市場領先地位,目前正持續強勁增長。Saphnelo 皮下製劑最近在歐洲獲得批准,這將使其惠及更多傾向於自行用藥的患者。我們預計今年上半年皮下注射Saphnelo將在其他地區獲得進一步批准,包括美國和日本。

  • 2026 marks a transition year for our CVRM franchise. We anticipate Lokelma's strong growth to continue into 2026 driven by market leadership within the growing potassium binder class. We have also increased additional manufacturing capacity to support our growth ambitions.

    2026年是我們商用車RM業務的轉型之年。我們預計,在不斷增長的鉀黏合劑類別中,Lokelma 的市場領導地位將推動其強勁成長勢頭持續到 2026 年。我們還增加了額外的生產能力,以支持我們的成長目標。

  • In 2026, as mentioned, we anticipate Farxiga VBP implementation in China during the first quarter and the first generic competition in the United States in April. While Farxiga revenues in the United States, Japan and China are expected to decline this year. We anticipate strong demand growth to continue in Europe and the emerging markets.

    如前所述,我們預計 Farxiga VBP 將於 2026 年第一季在中國實施,並於 4 月在美國迎來首個仿製藥競爭。儘管預計今年 Farxiga 在美國、日本和中國的營收將會下降。我們預計歐洲和新興市場的需求將持續強勁成長。

  • Looking beyond 2026, dapagliflozin fixed dose combinations have the potential to unlock new waves of medicines for patients, and we already have three fixed dose combinations of dapagliflozin in Phase III development with the first two Phase III trials due to readout in 2027.

    展望 2026 年以後,達格列淨固定劑量組合預計將為患者開啟新一輪的藥物浪潮,目前已有三種達格列淨固定劑量組合處於 III 期開發階段,其中前兩項 III 期試驗將於 2027 年公佈結果。

  • We are currently preparing for the launch of baxdrostat in uncontrolled and treatment-resistant hypertension. The US approval is anticipated to broadly coincide with the entry of generic dapagliflozin in this market, allowing us to leverage our existing commercial infrastructure. While baxdrostat will not be a major contributor to revenues in 2026, the clinical data supporting its use is compelling, and the long-term potential of this medicine is substantial with peak revenues from the products -- from this product franchise expected to exceed $5 billion.

    我們目前正在準備推出用於治療難治性高血壓的baxdrostat。預計美國批准該藥物的時間將與仿製藥達格列淨進入美國市場的時間大致相同,這將使我們能夠利用我們現有的商業基礎設施。雖然巴司他(baxdrostat)在 2026 年不會成為主要的收入來源,但支持其使用的臨床數據令人信服,而且這種藥物的長期潛力巨大,預計該產品系列的峰值收入將超過 50 億美元。

  • I will now hand over to Sharon, who will provide further details on the upcoming developments in our pipeline, including ATTR cardiomyopathy which represents a major potential growth driver for the BioPharmaceuticals business.

    現在我將把發言權交給莎倫,她將詳細介紹我們研發管線即將取得的進展,包括 ATTR 心肌病,這代表著生物製藥業務的一個主要潛在成長動力。

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

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Thanks, Ruud. Next slide, please. We saw strong progress across our biopharma clinical pipeline in 2025 and are entering 2026 with a broad and deep pipeline across CVRM and R&I. Today, I want to highlight two high-value Phase III catalysts anticipated this year positioned to deliver meaningful impact for patients and AstraZeneca's growth ambition.

    謝謝你,魯德。請看下一張投影片。2025 年,我們的生物製藥臨床研發管線取得了強勁進展,進入 2026 年,我們在心血管、呼吸和代謝疾病 (CVRM) 以及研發創新 (R&I) 領域擁有廣泛而深入的研發管線。今天,我想重點介紹今年有望進入 III 期臨床試驗階段的兩項高價值催化劑,它們有望為患者和阿斯特捷利康的成長目標帶來有意義的影響。

  • Starting with Wainua. We expect the cardio transform readout in ATTR cardiomyopathy in the second half of this year. Wainua is an anti-sense oligonucleotide designed selectively to suppress hepatic production of transthyretin addressing the upstream driver of amyloid fibril formation. ATTR cardiomyopathy is often underdiagnosed as symptoms overlap with common cardiac issues. Leading to delayed diagnosis, poor prognosis and high morbidity. This highlights the need for better diagnostics and innovative new treatment options.

    從瓦伊努阿開始。我們預計今年下半年將公佈 ATTR 心肌病變的 cardio transform 讀片結果。Wainua 是一種反義寡核苷酸,其設計目的是選擇性地抑制肝臟中轉甲狀腺素的產生,從而解決澱粉樣原纖維形成的上游驅動因素。ATTR 心肌病變常被漏診,因為其症狀與常見的心臟問題重疊。導致診斷延遲、預後不良和發病率高。這凸顯了對更好的診斷方法和創新治療方案的必要性。

  • CARDIO-TTRansform is the largest study ever conducted in this disease, enrolling more than 1,400 patients to receive Wainua or placebo on top of standard of care for 140 weeks. The trial's primary endpoint is a robust composite of cardiovascular mortality and recurrent cardiovascular clinical events designed to capture clinically meaningful outcomes.

    CARDIO-TTRansform 是迄今為止針對該疾病進行的最大規模研究,招募了 1400 多名患者,在接受標準治療的基礎上,接受 Wainua 或安慰劑治療,療程為 140 週。該試驗的主要終點是心血管死亡率和復發性心血管臨床事件的綜合指標,旨在捕捉具有臨床意義的結果。

  • Importantly, Wainua can be administered once monthly as a single dose via a subcutaneous auto-injector, enabling convenient at-home dosing. That's an advantage for this largely aging population. Wainua represents just one component of our leading amyloidosis portfolio, we believe that multiple mechanisms of action will be needed to address the full spectrum of ATTR cardiomyopathy, and we look forward to initiating clinical development of Wainua in combination with our DepleTTR, cliramitug in the near future.

    重要的是,Wainua 可以每月一次透過皮下自動注射器單一劑量給藥,方便在家給藥。這對人口老化程度較高的族群來說是一個優勢。Wainua 只是我們領先的澱粉樣變性產品組合中的一個組成部分,我們相信需要多種作用機制來解決 ATTR 心肌病變的全部問題,我們期待在不久的將來啟動 Wainua 與我們的 DepleTTR 和 cliramitug 聯合的臨床開發。

  • Turning now to the Phase III program for our differentiated IL-33 biologic, tozorakimab in COPD, which we anticipate will read out in the first half of this year. We have three trials ongoing. OBERON, TITANIA and MIRANDA, which have the potential to redefine the management of this complex heterogeneous and progressive disease. The trials all have the same primary end point, the reduction in annualized rate of moderate-to-severe COPD exacerbations in former smokers.

    現在我們來談談我們針對 COPD 的差異化 IL-33 生物製劑 tozorakimab 的 III 期臨床試驗項目,我們預計將在今年上半年公佈結果。我們目前有三項試驗正在進行中。OBERON、TITANIA 和 MIRANDA 有可能重新定義這種複雜、異質性且不斷進展的疾病的治療。所有試驗的主要終點都是相同的,即降低前吸菸者中重度 COPD 急性發作的年發生率。

  • The program will also evaluate efficacy in a broader COPD population, irrespective of eosinophil count or smoking status and explores a range of dosing regimens to maximize the potential population that could benefit from tozorakimab. Should the results be positive, tozorakimab could be the first-in-class IL-33 biologic for COPD.

    該計劃還將評估托佐拉單抗在更廣泛的 COPD 人群中的療效,無論嗜酸性粒細胞計數或吸煙狀況如何,並探索一系列給藥方案,以最大限度地擴大可能從托佐拉單抗中受益的潛在人群。如果結果呈陽性,托佐拉單抗可能成為首個用於治療 COPD 的 IL-33 生物製劑。

  • I also wanted to take the opportunity to highlight advances in our weight management portfolio. We are delighted to announce today that our once-daily oral GLP-1 receptor agonist, elecoglipron formerly known as AZD5004 met its primary endpoints in both the VISTA and SOLSTICE Phase IIb trials conducted in people with obesity or type 2 diabetes, respectively. We look forward to sharing these data at the American Diabetes Association meeting in June. Based on the strength of these data, we are progressing elecoglipron into Phase III development this year. We look forward to sharing more details once these trials initiate.

    我還想藉此機會重點介紹我們在體重管理產品組合方面的進展。我們今天很高興地宣布,我們每日一次口服的 GLP-1 受體激動劑 elecoglipron(以前稱為 AZD5004)在分別針對肥胖症患者和 2 型糖尿病患者進行的 VISTA 和 SOLSTICE IIb 期試驗中均達到了主要終點。我們期待在六月舉行的美國糖尿病協會會議上分享這些數據。基於這些數據的優勢,我們今年將推動 elecoglipron 進入 III 期臨床試驗階段。我們期待在試驗開始後分享更多細節。

  • Our overarching goal is to create a weight management portfolio that addresses obesity and its interconnected conditions. Our diversified pipeline uniquely positions us to explore innovative novel combinations. And alongside elecoglipron, we continue to advance our broader portfolio of different mechanisms, including a selective amylin receptor agonist AZD6234 as a monotherapy and in combination with our dual GLP-1/glucagon receptor agonist, AZD9550, both of which are expected to deliver first Phase II data this year. We also continued to invest in our earlier programs, augmented by recent external innovation to further strengthen our pipeline in this space.

    我們的總體目標是打造一套能夠解決肥胖及其相關問題的體重管理方案。我們多元化的產品線使我們能夠以獨特的優勢探索創新性的新組合。除了 elecoglipron 之外,我們還在繼續推進我們更廣泛的不同機制產品組合,包括選擇性胰淀素受體激動劑 AZD6234,可作為單藥療法以及與我們的雙重 GLP-1/胰高血糖素受體激動劑 AZD9550 聯合療法,預計這兩種療法都將在今年公佈首個 II 期數據。我們也持續投資於早期項目,並結合近期外部創新,進一步加強我們在該領域的研發實力。

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

    那麼,請繼續下一張投影片,接下來我將把麥克風交給馬克,讓他來介紹罕見疾病。

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

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

  • Thank you, Sharon. And can I get to the next slide, please? Rare disease delivered total revenue of $9.1 billion in 2025, up 4% over the next -- last year, driven by growth in neurology indications, increased patient demand and continued global expansion. In the quarter, Ultomiris grew 15%, driven by patient demand across indications, including the competitive gMG and PNH markets. Soliris revenues continued to decline due to the successful conversion to Ultomiris as well as biosimilar pressure.

    謝謝你,莎倫。我可以進入下一張投影片嗎?2025 年,罕見疾病業務的總收入達到 91 億美元,比上一年增長 4%,這主要得益於神經系統疾病適應症的增長、患者需求的增加以及全球業務的持續擴張。本季度,Ultomiris 成長了 15%,這主要得益於患者對各種適應症的需求,包括競爭激烈的 gMG 和 PNH 市場。由於成功轉型為 Ultomiris 以及生物相似藥的壓力,Soliris 的收入持續下降。

  • Strensiq grew 15% due to strong demand with a quarter benefiting from tender or the timing. We also saw strong underlying demand for Koselugo offset in the fourth quarter by all the timing in certain tender markets. We continue to see great momentum across the rare disease portfolio with further approvals for Koselugo and Ultomiris, expanding our geographic reach for these medicines.

    由於強勁的需求,Strensiq 成長了 15%,其中四分之一的收益得益於招標或時機。我們也看到,第四季度對 Koselugo 的強勁潛在需求被某些招標市場的時機問題所抵消。隨著 Koselugo 和 Ultomiris 的進一步獲批,我們在罕見疾病產品組合方面繼續保持強勁勢頭,擴大了這些藥物的地域覆蓋範圍。

  • Five years after announcing the acquisition, I'm pleased to report that Alexion has delivered low double-digit compounded annual growth from 2020 to 2025 at constant exchange rates. We have also significantly expanded our global reach. At the time of the acquisition, Alexion medicines were available in 20 countries by leveraging AstraZeneca footprint and the outstanding efforts of our teams, our life-changing rare disease therapies are now available in more than 75 countries worldwide.

    在宣布收購五年後,我很高興地報告,Alexion 在 2020 年至 2025 年期間,以固定匯率計算,實現了兩位數的複合年增長率。我們的全球業務範圍也顯著擴大。收購時,Alexion 的藥品已在 20 個國家上市。借助阿斯特捷利康的業務網絡和我們團隊的傑出努力,我們改變生命的罕見疾病療法現已在全球 75 多個國家/地區上市。

  • Finally, we have made meaningful progress in deepening scientific collaborations between AstraZeneca and Alexion researchers, further accelerating innovation. Our work across similar disease areas, such as transthyretin cardiac amyloidosis of the development of our dual CD19/BCMA CAR-T across multiple therapeutic areas are two evidences of this. This integrated approach enables the seamless exchange of technologies and advancements across medicinal and process chemistry, molecular editing and library platform. We have now more than 120 collaborative initiative across AstraZeneca and Alexion which are advancing our ambition to pioneer new treatments and lead in our core therapeutic area.

    最後,我們在深化阿斯特捷利康和Alexion研究人員之間的科學合作方面取得了實質進展,進一步加速了創新。我們在類似疾病領域(如轉甲狀腺素蛋白心臟澱粉樣變性)所進行的工作,以及我們在多個治療領域開發雙 CD19/BCMA CAR-T 療法,都是這方面的兩個證據。這種綜合方法實現了藥物化學、製程化學、分子編輯和庫平台等領域技術和進步的無縫交流。目前,阿斯特捷利康和 Alexion 之間已有超過 120 項合作計劃,這些計劃正在推進我們開拓新療法並引領核心治療領域的雄心壯志。

  • Please advance to the next slide. In 2026, we expect Ultomiris to grow -- to continue to grow, driven primarily by neurology indication including new-to-brand patients and those switching from Soliris as well as further market expansions. We indicated peak-year sales for Ultomiris to be above $5 billion with contribution from both existing and new indications, such as HSCT-TMA, IgAN and CSA-AKI.

    請進入下一張投影片。預計到 2026 年,Ultomiris 將繼續成長,主要成長動力來自神經系統適應症,包括新用戶和從 Soliris 轉用 Ultomiris 的用戶,以及市場的進一步擴張。我們預測 Ultomiris 的年銷售額高峰將超過 50 億美元,這得益於現有適應症和新適應症(如 HSCT-TMA、IgAN 和 CSA-AKI)的貢獻。

  • In the first half of the year, we anticipate high-level results in IgAN where we have guided for the first endpoint at 34 weeks assessing proteinuria. If positive, we will explore the potential for an accelerated approval in certain major markets. We also anticipate results from adult patients with HSCT-TMA. This data built on a positive finding from the single-arm pediatric study completed in 2025.

    今年上半年,我們預計 IgAN 將取得高水準的成果,我們已將第一個終點設定為 34 週,評估蛋白尿。如果結果積極,我們將探討在某些主要市場加快審批的可能性。我們也期待獲得 HSCT-TMA 成年患者的治療結果。這些數據建立在 2025 年完成的一項單臂兒科研究的正面結果之上。

  • For Strensiq, we expect continued adoption supported by hypophosphatasia guidelines, which have led to increased disease awareness, diagnosis rates and accelerated new patient starts. As global market expansion progresses, our priority remains advancing disease education to strengthen market readiness ahead of the readout for efzimfotase alfa which we anticipate in the first half of 2026.

    對於 Strensiq,我們預計在低磷酸酯酶症指南的支持下,該產品將繼續廣泛應用。這些指南提高了人們對該疾病的認識,提高了診斷率,並加快了新患者的治療。隨著全球市場擴張的推進,我們的首要任務仍然是推進疾病教育,以加強市場準備,為 efzimfotase alfa 的公佈做好準備,我們預計該結果將於 2026 年上半年公佈。

  • Patient demand and geographic expansion in pediatric patients, in addition to the recent approval in adult patients will continue to drive Koselugo's growth. We are well placed to deliver another year of strong performance, supported by global demand for rare disease medicine as well as meaningful indication expansion opportunities.

    兒科患者的需求和地理擴張,以及最近在成人患者中的獲批,將繼續推動 Koselugo 的成長。在全球對罕見疾病藥物的需求以及重要的適應症拓展機會的支持下,我們已做好充分準備,再創佳績。

  • Please advance to the next slide. Our antibody-based depletion portfolio for cardiac and systemic amyloidosis continue to advance with a focus on the two most prevalent form of amyloidosis, transthyretin and light chain. We announced the first Phase III results last year for our most advanced pipeline candidate, anselamimab. In the CARES Phase III program, anselamimab demonstrated a highly clinically meaningful improvement in both all-cause mortality and cardiovascular hospitalization in the subgroup of patients with kappa light chain amyloidosis. Global regulatory reviews and submissions are underway.

    請進入下一張投影片。我們針對心臟和全身性澱粉樣變性的抗體清除療法產品組合持續推進,重點關注兩種最常見的澱粉樣變性形式:轉甲狀腺素蛋白澱粉樣變性和輕鏈澱粉樣變性。去年,我們公佈了我們最先進的在研藥物 anselamimab 的首個 III 期臨床試驗結果。在 CARES III 期計畫中,安塞拉米單抗在 kappa 輕鏈澱粉樣變性患者亞群中,全因死亡率和心血管住院率均顯示出具有高度臨床意義的改善。全球監管審查申報工作正在進行中。

  • We have also expanded our collaboration with Neurimmune in December '25 to include NI009, a fibril depleting antibody for the lambda light chain amyloidosis which represents 80% of the light chain population and complement anselamimab to address the broad patient population. We have accelerated development plan to move this molecule as quickly as possible into the clinic.

    2025 年 12 月,我們也擴大了與 Neurimmune 的合作,將 NI009 納入其中。 NI009 是一種用於治療 lambda 輕鏈澱粉樣變性的纖維清除抗體,該疾病佔輕鏈人群的 80%,可與 anselamimab 互補,以應對廣泛的患者群體。我們已加快研發計劃,力求盡快將此分子推進臨床試驗。

  • Cliramitug, our first collaboration is Neurimmune is now in Phase III for ATTR cardiomyopathy. The DepleTTR trial completed enrollment, a full year ahead of plan with more than 1,000 patients recruited. As Sharon mentioned, we also plan to initiate a Phase IIb of our silence Wainua with our DepleTTR cliramitug and we believe the combination of these two medicines has the potential to deliver a new standard of care for patients with ATTR cardiomyopathy. The data generation to date reinforce our belief that targeted amyloid fibril depletion with specific antibodies can significantly reduce mortality and hospitalization transforming the course of the disease for these patients.

    Cliramitug,我們的第一個合作計畫是Neurimmune,目前該藥物正處於治療ATTR心肌病變的III期臨床試驗階段。DepleTTR 試驗已完成招募,比計劃提前整整一年,共招募了 1000 多名患者。正如 Sharon 所提到的,我們還計劃啟動我們針對 Silence Wainua 的 IIb 期臨床試驗,該試驗使用 DepleTTR cliramitug 藥物。我們相信,這兩種藥物的結合有可能為 ATTR 心肌病變患者提供新的治療標準。迄今為止的數據生成強化了我們的信念,即使用特定抗體靶向清除澱粉樣蛋白原纖維可以顯著降低死亡率和住院率,從而改變這些患者的疾病進程。

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

    那麼,請進入下一張投影片,我將把鏡頭交還給帕斯卡爾。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc. Please, next slide. As you can see here, the momentum of our pipeline continues, not just in 2026, but also through to 2027. We have a significant number of high-value Phase III trials that can read out and support our growth to 2030 and beyond. And in 2026 alone, the risk-adjusted combined figure revenue opportunities in excess of $10 billion, as I said before, and again, the same in 2027.

    謝謝你,馬克。請看下一張投影片。正如您在這裡看到的,我們的專案儲備勢頭不僅在 2026 年持續成長,而且一直延續到 2027 年。我們有大量高價值的 III 期試驗,這些試驗結果可以為我們 2030 年及以後的發展提供基礎和支持。正如我之前所說,光是 2026 年,經風險調整後的綜合收入機會就將超過 100 億美元,2027 年也是如此。

  • So if we move to the next slide. In closing, we saw strong commercial momentum and great delivery across the pipeline in 2025. And our confidence in delivering the $80 billion ambition by 2030 is definitely increasing. With our broad portfolio and our deep pipeline, the meaningful progress we're making with our multiple transformation technologies, we can definitely reach this $80 billion ambition we have, but also continue to grow post 2030.

    那麼,如果我們切換到下一張投影片。綜上所述,我們看到 2025 年整個產品線展現出強勁的商業動能和良好的交付能力。我們實現 2030 年達到 800 億美元目標的信心正在不斷增強。憑藉我們廣泛的產品組合和深厚的研發實力,以及我們在多種轉型技術方面取得的顯著進展,我們不僅能夠實現 800 億美元的目標,而且還能在 2030 年之後繼續成長。

  • So if we move to the next slide. Before we move to the Q&A, I want to thank Andy Barnett for his amazing contribution as Head of Investor Relations over the last few years. I know he has enjoyed very much interacting with you, and I'm sure you have enjoyed interacting with him. He's very knowledgeable. He's a great guy and he has a great sense of humor. So definitely a pleasure working with Andy, certainly for me and for the team, and I'm sure it was the case for you. I want to wish Andy a great success in his new role as Country President for Japan. I'm sure he will make a great contribution to our company in Japan, just like you did to the IR function.

    那麼,如果我們切換到下一張投影片。在進入問答環節之前,我要感謝 Andy Barnett 在過去幾年裡作為投資者關係主管所做的卓越貢獻。我知道他很享受和你相處的時光,我也相信你也很享受和他相處的時光。他知識淵博。他是個很棒的人,而且很有幽默感。所以和安迪一起工作絕對是一種樂趣,對我個人和團隊都是如此,我相信對你來說也是如此。我祝福安迪在擔任日本區總裁的新職位上取得巨大成功。我相信他會像你為IR部門所做的那樣,為我們在日本的公司做出巨大貢獻。

  • I also want to welcome Joris, who must be somewhere in the room, okay. I welcome Joris. So Joris was until recently the Country President for the US, Biopharma and overall President, Representative of AZ in the United States. And Joris has driven tremendous growth throughout our company in the United States, in particular, built Farxiga to what it is, Fasenra, Tezspire and really done a great job. Joris before being in the US worked in Asia. And so he has really great experience across Asia, the US and Europe. And since he joined the company in 2000. So I'm sure Joris will also do a great job in IR, and I'm sure you'll enjoy working with him.

    我還要歡迎喬里斯,他肯定就在房間裡的某個地方,好嗎?我歡迎喬里斯。所以,Joris 直到最近還是 AZ 在美國的美國生物製藥總裁兼總總裁兼代表。Joris 為我們公司在美國的業務帶來了巨大的成長,尤其是在 Farxiga、Fasenra 和 Tezspire 這幾家公司的發展上,他真的做得非常出色。喬里斯在來美國之前曾在亞洲工作。因此,他在亞洲、美國和歐洲都擁有非常豐富的經驗。自他 2000 年加入公司以來。所以我相信 Joris 在 IR 方面也會做得很好,我也相信你會喜歡和他一起工作。

  • So if we move to the next slide, as Andy mentioned at the start of the call, please limit the number of questions you ask to allow everybody a fair chance to participate. (Event Instructions) And with that, let's move to the first question. There are so many first questions. Over to you.

    所以,如果我們進入下一張幻燈片,正如安迪在通話開始時提到的那樣,請限制您提問的數量,以便每個人都有公平的參與機會。(活動說明)接下來,讓我們進入第一個問題。有很多問題需要解答。接下來該你了。

  • Luisa Hector - Equity Analyst

    Luisa Hector - Equity Analyst

  • Thank you, Pascal. So I've got two questions, please. I wanted to think a little bit about the growth beyond 2030, but it does connect to the readouts in 2026. You talked about the $10 billion risk-adjusted peak sales potential. Can you give us any more color on that, the mix of the $10 billion, the risk adjustments you've assumed any assets, in particular, dominating the $10 billion? And should we assume higher success rates now for AstraZeneca after last year's strong performance? So that's the readouts this year and the link to the growth beyond 2030.

    謝謝你,帕斯卡爾。我有兩個問題,請問。我想稍微思考一下 2030 年以後的成長情況,但這確實與 2026 年的統計數據有關。你提到了經風險調整後100億美元的銷售高峰潛力。您能否更詳細地介紹一下這100億美元的組成,以及您所承擔的風險調整,特別是那些在100億美元中占主導地位的資產?鑑於阿斯特捷利康去年的強勁表現,我們是否應該預期它今年的成功率會更高?以上就是今年的數據以及與 2030 年以後成長的連結。

  • And then I'd love to hear an update from Iskra on China, 2026, a lot of moving parts but some good new launches and reimbursement going on as well. So just an update there on how we should think about '26 and perhaps some color on profitability of China versus history versus the rest of the group?

    然後我很想聽聽 Iskra 關於 2026 年中國市場的最新進展,雖然有很多變數,但也有一些不錯的新產品發布和報銷政策出台。那麼,關於我們該如何看待2026年,能否更新一下相關資訊?或許還可以分析一下中國在獲利能力上與歷史數據以及其他國家相比的優劣?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you. Iskra, do you want to cover the second one? And maybe for the first one, we'll have to get input from a number of people there. But go ahead, Iskra to start.

    謝謝。伊斯克拉,你想負責第二個嗎?或許對於第一個問題,我們需要聽聽那裡許多人的意見。伊絲卡,你先開始吧。

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

    Iskra Reic - Executive Vice President - Vaccines and Immune Therapies

  • Thanks, Luisa, for the question. So let me start by saying that we are very happy to see the strong performance in China in '25 and it definitely gives us a confidence.

    謝謝路易莎的提問。首先我想說,我們非常高興地看到中國在 2025 年取得了強勁的成績,這無疑給了我們信心。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Can you speak in the microphone?

    你會對著麥克風說話嗎?

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

    Iskra Reic - Executive Vice President - Vaccines and Immune Therapies

  • So let me try. Is it better now? It definitely gives the confidence in the outlook of '26. Now when you think about '26 in China, I think there are two main components. One is obviously the headwind of the VBP for Farxiga, roxadustat and Lynparza. And as we have always seen, there is expectations from the decline post VBP that is driven by both price decrease as well as volume reduction. But when it comes specifically to Farxiga, I do believe that we can also expect the brand recovery in the midterm, and we saw the similar trend with the Betaloc and CRESTOR in the past. And it is really driven by the strong brand perception, strong brand loyalty and recovery, specifically in the retail channel.

    那我就試試吧。現在好些了嗎?這無疑增強了人們對2026年前景的信心。現在,當你想到中國的“26”,我認為有兩個主要組成部分。顯然,VBP 對 Farxiga、roxadustat 和 Lynparza 構成了不利影響。正如我們一直以來所看到的,VBP 之後的下滑預期是由價格下降和銷售減少共同導致的。但就 Farxiga 而言,我相信我們也可以期待品牌在中期內復甦,我們過去也曾在 Betaloc 和 CRESTOR 身上看到類似的趨勢。這主要得益於強大的品牌認知、強大的品牌忠誠度和復甦能力,尤其是在零售通路。

  • When it comes to the tailwinds in China, we feel very confident that we will continue to see the growth of the new launches, specifically driven by our success of including Fasenra, Truqap and Calquence tablets in the NRDL starting of January 1 this year. When you think about the Enhertu performance post-NRDL, they've mentioned that in his presentation, we saw very strong uptake and our ability to include Enhertu in the more than 1,000 hospital listings in the less than a quarter gives us the confidence that we will be able to see the successful launches going forward.

    就中國市場的順風而言,我們非常有信心,新產品的推出將繼續成長,這主要得益於我們成功地將 Fasenra、Truqap 和 Calquence 片劑從今年 1 月 1 日起納入國家藥品目錄。當你回顧 Enhertu 在 NRDL 之後的表現時,正如他們在演講中提到的,我們看到了非常強勁的市場接受度,並且在不到一個季度的時間裡,我們就能將 Enhertu 納入 1000 多家醫院的名單中,這讓我們有信心在未來看到成功的推出。

  • When it comes to the profitability, profitability in China is still lower than the group. But I think you always need to think about a huge volume and huge unmet need and opportunity there and put that in the perspective of the -- a bit lower prices than in the rest of the world.

    就獲利能力而言,中國市場的獲利能力仍然低於集團平均。但我認為你始終需要考慮那裡巨大的市場規模和巨大的未滿足需求和機遇,並將其置於——比世界其他地方略低的價格——這個角度來看。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • In your first question, I had like two sub-questions really. And then the second sub-question was about success rate. And I wish that we continue experiencing the same success rate, but I don't think we can promise this because, as you know, the risk is part of our industry, really. And we have to brace and accept the fact -- brace for the fact that we actually will experience failures.

    你的第一個問題其實包含了兩個子問題。第二個子問題是關於成功率的。我希望我們能繼續保持同樣的成功率,但我認為我們不能保證這一點,因為正如你所知,風險確實是我們這個行業的一部分。我們必須做好準備接受這個事實──做好準備面對我們確實會經歷失敗的事實。

  • Now having said that, I'd like to ask maybe Susan to do two things. One is to talk about the joint venture, the project, we are working together with Tempus and using AI and multi-model model to actually help improve the probability of success in our studies and better shape them. So you can sort of give a little bit of highlights on this and then comment on what are the two or three big projects, not too many, two or three big projects you think will drive growth in oncology hematology?

    說了這麼多,我想請蘇珊做兩件事。一方面,我們想談談合資企業和項目,我們正在與 Tempus 合作,利用人工智慧和多模型來實際提高我們研究的成功機率,並更好地塑造研究方向。所以您可以先簡單介紹一下這方面的重點,然後評論一下您認為將推動腫瘤血液學領域發展的兩三個大項目是什麼?不用太多,兩三個大項目就好。

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

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

  • Yeah. Thanks, Pascal. So my reflection, if you like, of the last decade in oncology about the success rates we've had has been predicated on being able to identify the right patient population to treat. You've seen that there's been important with Lynparza, it's been important with Tagrisso. I think that continues to be something that's important.

    是的。謝謝你,帕斯卡。所以,如果你願意的話,我對過去十年腫瘤學領域所取得的成功率的反思是,我們能夠確定合適的患者群體進行治療。你已經看到,Lynparza 和 Tagrisso 都發揮了重要作用。我認為這一點仍然很重要。

  • The foundation model work that we go with Tempus and Pathos as the ambition is that we'll have the largest multimodal foundation model that will take the unstructured data that's in patient records, the lab data, the genomics data, transit data were available imaging and pathology and integrate all of that into the largest foundation model for oncology because of the large data set that we have with Tempus and Pathos.

    我們與 Tempus 和 Pathos 合作進行的基礎模型工作的目標是,建立最大的多模態基礎模型,該模型將整合患者記錄中的非結構化數據、實驗室數據、基因組數據、轉運數據(如有)、影像和病理數據,並將所有這些數據整合到最大的腫瘤學基礎模型中,因為我們擁有 Tempus 和 Pathos 的龐大數據集。

  • The hope is, I mean what we've already been doing is using those kinds of real-world evidence data sets to both help design our Phase III trials and predict what the control arm performance is going to be, particularly when you're going in with a new biomarker, you don't necessarily have the historical literature data, but if you can benchmark that using these data, it's helpful. So the idea is that you would reduce the uncertainty in both the design and the production of outcome of Phase III trials by using these foundation models.

    我們希望,我們一直在做的,就是利用這些真實世界的證據數據集來幫助設計我們的 III 期試驗,並預測對照組的表現,尤其是在使用新的生物標誌物時,你不一定有歷史文獻數據,但如果你能用這些數據進行基準測試,那就很有幫助了。因此,其理念是利用這些基礎模型來降低 III 期試驗設計和結果產生的不確定性。

  • The hope is also that you could better identify the patient populations where the biology is a little more complicated. So we're still relying, for example, on PD-L1 in the IO space as the only biomarker that has really broadly been uptaken. And everybody is aware that, that is imperfect. So I think this technology can really help in those spaces. Still to be proven, but I'm optimistic that, that can make a difference.

    希望還能更能辨識生物學特性較為複雜的患者群。因此,例如,在 IO 領域,我們仍然依賴 PD-L1 作為唯一被廣泛採用的生物標記。大家都知道,這並不完美。所以我認為這項技術在這些領域真的能有很大的幫助。雖然還有待驗證,但我樂觀地認為,這可能會產生影響。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Dave, do you want to cover the second part of the -- and then Ruud if you could also talk about a couple of products in biopharma with drive costs?

    Dave,你想講第二部分嗎? ——Ruud,你能不能也談談生物製藥領域中一些與驅動成本相關的產品?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • So Luisa, very specifically on the readouts that Pascal went through. EMERALD-3 is a blockbuster plus opportunity in HCC. And I think builds off of a program that has currently success with Imfinzi. Certainly, when you take a look at data across AVANZAR07, that is for just the AZ share alone, multi-blockbuster opportunity if those studies are positive, and we've got an opportunity to move forward with that.

    所以 Luisa,具體來說,是關於 Pascal 經歷的那些讀數。EMERALD-3 是治療肝細胞癌的重磅炸彈級藥物。我認為這是在 Imfinzi 目前取得成功的專案基礎上發展起來的。當然,當你查看 AVANZAR07 的數據時,你會發現這僅僅是 AZ 的份額,如果這些研究結果是積極的,那麼這將是一個多重磅藥物的機會,我們有機會推進這項工作。

  • SERENA-4 is multi-blockbuster in terms of the opportunity that it represents. And then lastly, PAC-9, we don't talk a lot about PAC-9, but I think PAC-9, if that study were to come through, gives an opportunity to actually build off of our Pacific leadership where we've been able to enjoy a space without having much competition coming into the area. So those are the highlights I'd hit.

    SERENA-4 計畫從其所代表的機會來看,堪稱一項重大突破。最後,PAC-9,我們很少談論 PAC-9,但我認為,如果這項研究能夠成功,PAC-9 將為我們提供一個機會,讓我們能夠鞏固我們在太平洋地區的領先地位,在這個地區,我們一直享有一個沒有太多競爭對手的空間。以上就是我重點提到的幾個面向。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yeah. And a few highlights from a biopharma perspective, laroprovstat, our oral PCSK9. We're going to expect the first data set in the course of 2027 is, in our view, a very high potential -- potentially a $5 billion-plus potential. Clearly, baxdrostat, I'm sure many more questions about baxdrostat. It's not only the mono component but also the combination, I think, with the SGLT2, dapagliflozin is a very important one.

    是的。從生物製藥的角度來看,有幾個亮點,例如 laroprovstat,我們的口服 PCSK9 抑制劑。我們預計 2027 年的第一個資料集將具有非常高的潛力——可能超過 50 億美元。顯然,baxdrostat,我確信還有很多關於baxdrostat的問題。我認為,不僅是單一成分,而且聯合用藥也很重要,達格列淨與 SGLT2 抑制劑合併用藥就非常重要。

  • And then the other two combinations, balci and dapa in kidney disease and heart failure, there's a high unmet medical need. And the combination of zibotentan and dapagliflozin has sales potential of between $3 billion and $5 billion. So there are a couple of big products. And then, of course, the bonus will be potentially those, as mentioned by Sharon, is a high unmet medical need still in the COPD space. If the product is hitting the TPP, I firmly believe that this will be a multibillion-dollar opportunity as well.

    另外,在腎臟病和心臟衰竭方面,巴爾西和達帕米鬆的兩種組合,存在著很高的未滿足醫療需求。而齊博坦坦和達格列淨的組合銷售潛力在 30 億美元至 50 億美元之間。所以這裡有幾款大品。當然,正如莎倫所提到的,COPD領域仍然存在著很高的未滿足的醫療需求,而獎金可能就來自於這些需求。如果該產品能夠進入TPP市場,我堅信這將也是一個價值數十億美元的機會。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • I got to stay on this table, but please, one question. I'll pick one question and give the second one. If you have a second one follow-up.

    我必須留在這張桌子上,但是請允許我問一個問題。我會選一個問題,然後給第二個問題。如果還有第二個問題,請跟進。

  • Richard Vosser - Analyst

    Richard Vosser - Analyst

  • Richard Vosser, JPMorgan. Maybe thoughts on the implications of the lidERA result over to the SERENA-4 trial in terms of design. Susan, you mentioned choosing the right patient population. Just thoughts on what you've done in SERENA-4 on the back of the lidERA result. And maybe if I can sneak it, thoughts on CAMBRIA-1 as well, given what lidERA just does that impact the commerciality. Pascal, ignore that if that is two.

    理查沃瑟,摩根大通。或許可以思考 lidERA 試驗結果對 SERENA-4 試驗設計的影響。蘇珊,你曾提到選擇合適的患者群體。基於 lidERA 的結果,我對您在 SERENA-4 中所做的工作有一些想法。如果可以的話,我還想談談我對 CAMBRIA-1 的看法,因為 lidERA 所做的一切都會影響其商業性。帕斯卡,如果那是二,就忽略它。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • I will grant you the second one because it's still related to CAMBRIA anyway. So over to you, Susan.

    我會同意你的第二個要求,因為它仍然與坎布里亞有關。那麼,蘇珊,該你上場了。

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

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

  • So I mean, I think what we've now seen is proof, as we've been saying consistently that is -- because of the mechanism of action of both full antagonism and inhibition of estrogen receptor, but also degradation can have activity not just in the ESR1, but in the endocrine-sensitive is so wild type. And I think you've seen that. We've been saying it for a while. But when you look at the second-line setting, that is less endocrine sensitive and so the effect size has been smaller there.

    所以我的意思是,我認為我們現在看到的就是證據,正如我們一直所說的那樣——因為雌激素受體的完全拮抗和抑制的作用機制,以及降解作用,不僅在 ESR1 中,而且在內分泌敏感的野生型中也具有活性。我想你已經看到了這一點。我們已經說了很久了。但如果你看看二線治療方案,你會發現它對內分泌系統的敏感度較低,因此效果也較小。

  • So the basis of SERENA-4's confidence is that we have try to design the study to enrich for the endocrine-sensitive components of the first-line setting. That's based on recruiting patients with recurrence of early-stage disease after at least two years of its standard adjuvant therapy because those that are less adequate sensitive will progress rapider than that. At least 12 months must have elapsed since the patient's last dose of the adjuvant AI. And then there's this some patients with de novo stage IV disease. So these are clinical features that are enriched -- to enrich for the endocrine-sensitive patient population.

    因此,SERENA-4 的信心基礎在於,我們努力設計這項研究,以豐富第一線治療中內分泌敏感成分。這是基於招募接受至少兩年標準輔助治療後早期疾病復發的患者,因為對治療敏感性不足的患者病情進展會更快。自從患者上次接受輔助性 AI 治療以來,至少要經過 12 個月。此外,還有一些患者是新發生的 IV 期疾病。因此,這些臨床特徵被強化—以強化內分泌敏感患者群體。

  • Of course, what you've also got is potentially the prevention of emergence of ESR1 mutations because you are essentially blocking that clonal selection drive because of the mechanism of action. So that's what underpins our confidence in SERENA-4. And I think having seen the fact that you've got activity in an adjuvant setting in an endocrine-sensitive population increases the confidence in that. But obviously, there still those trial design features. And of course, it's in combination with the CDK4/6 inhibitor.

    當然,由於其作用機制,你實際上阻止了克隆選擇驅動,因此你也有可能阻止 ESR1 突變的出現。這就是我們對 SERENA-4 充滿信心的根本原因。我認為,看到在內分泌敏感族群的輔助治療環境中取得療效,會增強人們對該療法的信心。但顯然,試驗設計中仍存在這些特點。當然,它也與 CDK4/6 抑制劑聯合使用。

  • To your second question about CAMBRIA-1. Again, I would just point out that we're the only company that has two adjuvant studies with our SERD, 1 designed for the patient population after two to five years of [CDK4/6], which is CAMBRIA-1 and the other from the patient population newly diagnosed, which is CAMBRIA-2. That gives us the opportunity to be able to -- if we're successful to access the largest group of patients in the adjuvant setting from those two different patient populations.

    關於你提出的第二個問題,即CAMBRIA-1。我再次強調,我們是唯一一家針對我們的 SERD 進行兩項輔助治療研究的公司,一項研究針對 [CDK4/6] 治療 2 至 5 年後的患者群體,即 CAMBRIA-1,另一項研究針對新確診的患者群體,即 CAMBRIA-2。如果成功,這將使我們有機會從這兩個不同的患者群體中獲得輔助治療領域中最大的患者群體。

  • And of course, the other difference is that we are allowing a combination with abemaciclib, which is going to be very relevant as the data continue to mature for CDK4/6 in the adjuvant setting. So I think that was the basis of the trial design that we had, and we're optimistic that those trials will read out positive given proof of principle, if you like, that this class can have a difference there.

    當然,另一個區別在於我們允許與 abemaciclib 聯合使用,隨著 CDK4/6 在輔助治療方面的數據不斷成熟,這將非常重要。所以我認為這就是我們試驗設計的基礎,我們樂觀地認為,鑑於原理驗證(如果你願意這麼說的話),這些試驗將會得出積極的結果,證明這一類藥物可以在這方面發揮作用。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Next we just finished this table.

    接下來我們完成了這張表格。

  • Matthew Weston - Analyst

    Matthew Weston - Analyst

  • I think I've got the mic Pascal, if I can. It's Matthew Weston from UBS. One question, please, on elecoglipron, if I can. You've made the announcement that you're moving to Phase III, which I assume indicates confidence in the Phase II profile that you've seen. But I could read that two ways because you also have a unique target product profile, I think, in Phase III because you're looking about weight management in combination with other parts of your cardiovascular portfolio.

    我想我拿到麥克風了,帕斯卡,如果可以的話。我是瑞銀集團的馬修‧韋斯頓。請問我可以問一個關於依來格列酮的問題嗎?你們已經宣布將進入第三階段,我認為這顯示你們對第二階段的進展充滿信心。但我可以從兩個方面來理解,因為我認為,你們在 III 期臨床試驗中也有著獨特的目標產品定位,因為你們正在研究如何將體重管理與心血管產品組合的其他部分結合起來。

  • So can you make some comments as to whether or not for you being confident to drive that move to Phase III means that you think you have efficacy at least as good or better than the competition or whether or not you think that it meets your target product profile of at least achieving modest weight loss which you can then use in combination with other agents?

    那麼,您能否就以下幾點發表一些看法:您有信心推進到 III 期臨床試驗,是否意味著您認為該產品的療效至少與競爭對手一樣好或更好?或者,您認為該產品符合您的目標產品特性,即至少能達到適度的減肥效果,然後可以與其他藥物合併使用?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Let me just answer this one because it's easy to answer, actually is, we would never move a product in Phase III and unleash the kind of spend we have. We are committing to if we didn't think we have a product with a competitive profile. So I think the short answer to your question is, we believe we have a very competitive profile and it doesn't rely on combinations. It actually relies on the amount of therapy itself. And of course, combination comes on top. But if monotherapy was not competitive, it would be hard to move it into Phase III and unlock so much investment. Maybe, James.

    讓我來回答這個問題,因為它很容易回答,實際上也確實如此,我們永遠不會在第三階段推進產品研發,也不會釋放我們擁有的那種支出規模。如果我們認為我們的產品不具備競爭力,我們就會做出承諾。所以,我認為對你問題的簡短回答是,我們相信我們擁有非常有競爭力的產品組合,而且這種競爭力並不依賴產品組合。實際上,這取決於治療本身的量。當然,組合運用才是王道。但如果單藥療法沒有競爭力,就很難將其推進到 III 期臨床試驗階段,從而獲得如此多的投資。也許吧,詹姆斯。

  • Unidentified Participant

    Unidentified Participant

  • James from Barclays. One of the Phase III readouts in the first half is efzimfotase alfa which I think had been based is a $3 billion to $5 billion opportunity. But I'm aware there's three different trials. So is it all or nothing to get the $3 billion to $5 billion or other scenarios where some trials are more or less successful? And how would that break down?

    巴克萊銀行的詹姆斯。上半年公佈的 III 期臨床試驗結果之一是 efzimfotase alfa,我認為它的價值在 30 億至 50 億美元之間。但我知道有三種不同的審判方式。所以,是必須全力以赴才能獲得 30 億至 50 億美元的資金,還是採取其他一些試驗成功率較高或較低的做法?那具體會如何分解呢?

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

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

  • Yes. So thank you for asking the question there. As you are mentioning, there are 3 trials. There are 2 trials in the pediatric population, where Strensiq was originally approved. One of this trial is a switch from Strensiq to efzimfotase. There is another trial in the pediatric population in the naive -- in Strensiq-naive population against placebo. And the third trial combines both adolescent and adult. You know that the level of Strensiq, depending on the jurisdiction is usually focusing on the pediatric population.

    是的。所以,謝謝你提出這個問題。正如你所提到的,共有 3 次試驗。Strensiq 最初獲準用於兒科族群,目前有 2 項針對兒科族群的試驗。其中一項試驗是將藥物從Strensiq換成efzimfotase。還有一項針對未接受過 Strensiq 治療的兒童患者的試驗,該試驗將 Strensiq 與安慰劑進行比較。第三項試驗同時納入了青少年和成年人。你知道,根據不同司法管轄區的規定,Strensiq 的劑量通常主要針對兒科族群。

  • And sometimes, we have adult with pediatric onset in the label, but the intent of the efzimfotase program was to test in the totality of the population from pediatric, adolescent, adult -- and even adult of a certain age, if I may say, So this is what this program of 1850 covers, so that we would know the answer to the question. We have been asking a lot about Strensiq. And we are now expecting the results in the first half of 2026 and we'll put all this together and hopefully, we'll be able to submit for a product that is much easier another enzyme therapy product, but much easier to utilize than Strensiq, which has to be administered every day or every other day, which, of course, is very cumbersome.

    有時,標籤上會寫著“成人,兒童期發病”,但efzimfotase計劃的目的是對整個人群進行測試,包括兒童、青少年、成人,甚至包括特定年齡段的成人。如果我沒理解錯的話,這就是1850年這項計畫涵蓋的內容,以便我們能夠知道問題的答案。我們一直在詢問有關Strensiq的資訊。我們現在預計在 2026 年上半年得到結果,我們將把所有這些整合起來,希望我們能夠提交一種產品申請,這種產品是另一種酶療法產品,但比 Strensiq 更容易使用,Strensiq 必須每天或隔天服用,這當然非常麻煩。

  • So this product would be provided once every other week, it would provide a great benefit. And if we demonstrate efficacy and safety in the total population, this would make efzimfotase alfa a product several times the value of Strensiq.

    因此,該產品將每隔一周提供一次,這將帶來很大的好處。如果我們證明 efzimfotase alfa 在全體人群中具有療效和安全性,那麼它將成為價值是 Strensiq 數倍的產品。

  • Michael Leuchten - Analyst

    Michael Leuchten - Analyst

  • It's Michael Leuchten from Jefferies. I think this is for Dave and Susan. TROPION-Lung07 now has QCS in the protocol. Is that also the plan for TROPION-Lung08? And can you talk about the relative importance of AVANZAR versus TL07 or TL08?

    我是 Jefferies 的 Michael Leuchten。我想這是給戴夫和蘇珊的。TROPION-Lung07 方案中現在包含 QCS。TROPION-Lung08 的計畫也是這樣嗎?您能否談談 AVANZAR 與 TL07 或 TL08 相比的相對重要性?

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

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

  • Do you want to go first? Okay. Thanks for the question. So TROPION-Lung08 is only in the PD-L1 greater than 50% patient population, which is a smaller segment overall. So if you just look at the trial characteristics, it makes sense for the biomarker to be applied within the TL07 population. And that's what the priority has been there. Very similar to what we've seen with the AVANZAR redesign where we put it at the -- in the ITT, but also in the biomarker-positive patient population.

    你想先來嗎?好的。謝謝你的提問。因此,TROPION-Lung08 僅適用於 PD-L1 表達大於 50% 的患者群體,而這部分患者總體而言數量較少。所以,如果只看試驗特徵,那麼將生物標記應用於 TL07 族群是合理的。這就是當時的首要任務。這與我們在 AVANZAR 重新設計中看到的情況非常相似,我們將其置於 ITT 中——以及生物標記陽性患者群體中。

  • Obviously, between AVANZAR and TL07, we'll be answering the question about the added benefit of platinum in addition as well. And I think these are all important trials that have the opportunity to really position Datroway as a key component of the first-line setting across multiple segments of that patient population.

    顯然,在 AVANZAR 和 TL07 之間,我們也會回答鉑金帶來的額外好處這個問題。我認為這些都是重要的試驗,有機會真正將 Datroway 定位為該患者群體多個細分市場的一線治療的關鍵組成部分。

  • Graham Parry - Analyst

    Graham Parry - Analyst

  • Graham Parry from Citi. So it's another question follow-up to Richard's question on camizestrant in the adjuvant setting. So CAMBRIA-1 is looking at essentially switch from aromatase inhibitors, but the giredestrant and lidERA study suggest that perhaps that market opportunity might be quite small over time if giredestrant is become standard of care in naive patients in the intermediate risk setting. So is there any plans to run a lidERA-like study or would you be looking predominantly the market opportunity here coming in the high-risk population in combination with [Verzenio]?

    來自花旗銀行的格雷厄姆·帕里。這是對 Richard 關於卡美司群在輔助治療中應用的問題的後續問題。因此,CAMBRIA-1 基本上是考慮從芳香化酶抑制劑轉向其他藥物,但 giredestrant 和 lidERA 研究表明,如果 giredestrant 成為中度風險初治患者的標準治療方案,那麼隨著時間的推移,市場機會可能會非常小。那麼,是否有計劃進行類似lidERA的研究,還是主要著眼於高風險族群的市場機遇,並結合其他因素進行研究?[Verzenio]?

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

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

  • So just to go over again, the CAMBRIA-2 studies in a setting that's very similar to lidERA, but it does allow for the combination with abemaciclib, which I think is going to become an increasing piece. So of course, what lidERA doesn't answer is relevance of the oral SERD in that context. And given that we think that CDK4/6 prevalence in the adjuvant setting is going to grow. I think it's very important to have the data with and without that combination and after a period of CDK4/6. That's why I'm saying, when you look at the 2 trials in totality, I think it gives us the opportunity to have the greatest segment of the patient population in the adjuvant should they both be positive.

    再回顧一下,CAMBRIA-2 研究的設定與 lidERA 非常相似,但它允許與 abemaciclib 聯合使用,我認為這將成為越來越重要的組成部分。所以,lidERA 無法回答的是口服 SERD 在這種情況下的相關性。鑑於我們認為 CDK4/6 在輔助治療中的盛行率將會成長。我認為,獲得有無該組合以及經過一段時間的 CDK4/6 治療後的數據非常重要。所以我才說,當你把這兩項試驗整體來看時,我認為如果兩項試驗結果都呈陽性,這將給我們一個機會,讓最大比例的患者群體接受輔助治療。

  • I don't know, Dave, if you want to comment?

    戴夫,我不知道你想發表什麼評論?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Yes. I'd simply amplify and echo some of the things that you had said previously, Susan on this, which is, if you think about CAMBRIA-1, which is in this two to five-year population, that's the prevalent population. And so while it's true that over time, the upfront CAMBRIA-2 population, we would expect to grow. There is a large population of patients that are prevalent on AI and AI CDK4/6. And the program allows for looking at both AI and CDK4/6 combinations. It's the broadest program that also allows both that prevalent and incident pool, and it allows us to be in a competitive set of time lines by putting it together in the way that we have.

    是的。蘇珊,關於這一點,我只想補充和重申你之前說過的一些話,那就是,如果你想想 CAMBRIA-1,它存在於兩到五年的人口中,這就是普遍存在的人口。因此,隨著時間的推移,CAMBRIA-2 的早期人口數量預計會增加。目前有大量患者正在接受 AI 和 AI CDK4/6 治療。該程式允許查看 AI 和 CDK4/6 的組合。這是覆蓋面最廣的計劃,它既涵蓋了普遍存在的事件,也涵蓋了突發事件,而且透過我們目前的方式將其整合在一起,使我們能夠在時間安排上具有競爭力。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Dave. Can we go here and then maybe there.

    謝謝你,戴夫。我們可以先去這裡,然後再去那裡嗎?

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Simon Baker from Rothschild & Co Redburn. One if I may, please, probably for Sharon. Could you just remind us of the points of differentiation of tozorakimab both in terms of the molecule and trial design and how that underpins your confidence in the program?

    來自羅斯柴爾德公司雷德本分公司的西蒙‧貝克。如果可以的話,請給我一個,大概是給莎倫的。您能否簡要介紹一下托佐拉單抗在分子結構和試驗設計方面的獨特之處,以及這些獨特之處如何增強您對該專案的信心?

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

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Sure. Thanks for the question. So the story about tozorakimab is the same one that we've been telling all along, which is that we think we have a highly differentiated IL-33 biologic. And the reason we think it's differentiated is because our molecule is able to hit both the ST2 pathway as well as the RAGE EGFR pathway and importantly, to impact signaling downstream event. And why does that matter?

    當然。謝謝你的提問。所以關於托佐拉單抗的故事和我們一直以來講述的故事是一樣的,那就是我們認為我們擁有高度差異化的IL-33生物製劑。我們認為它之所以與眾不同,是因為我們的分子能夠同時作用於 ST2 通路和 RAGE EGFR 通路,更重要的是,還能影響下游訊號傳導事件。這為什麼重要呢?

  • Because being able to inhibit signaling through RAGE EGFR is impacting mucus production and epithelial remodeling. And that's incredibly important in COPD where mucus production drives exacerbation, exacerbations drive mucus production, and it gives you a vicious cycle. So we think that's a really important component to our IL-33. Now as you know, we've designed a broad study to allow us to examine the efficacy of tozorakimab in current and former smokers. Our primary readout is in smokers, but we're looking at a broad population across eosinophil levels and across smoking status so that we have the opportunity to bring this to the broadest possible patient population.

    因為抑制 RAGE EGFR 訊號傳導會影響黏液產生和上皮重塑。而這對慢性阻塞性肺病極為重要,因為黏液產生會導致病情加重,病情加重又會導致黏液產生,進而形成惡性循環。所以我們認為這是我們IL-33的一個非常重要的組成部分。如您所知,我們設計了一項廣泛的研究,以便檢驗托佐拉單抗對目前吸菸者和先前吸菸者的療效。我們的主要研究對像是吸菸者,但我們正在研究不同嗜酸性粒細胞水平和吸菸狀況的廣泛人群,以便有機會將這項研究推廣到盡可能廣泛的患者群體。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Can we tie one more question in the room, and then we'll take Steve Scala's question online. Can we get a microphone over there?

    我們可以在房間裡再問一個問題,然後我們會把史蒂夫·斯卡拉的問題放到網路上討論。我們能把麥克風搬過去嗎?

  • Christopher Uhde - Analyst

    Christopher Uhde - Analyst

  • Christopher Uhde from SEB. It's on Calquence and the room for growth. It's done a nice job beating again lately. Consensus has about 10%, give or take, growth for '26 or '25 and then another 10% from then to about 2031, so peaks $4.4 billion. So will AMPLIFY live up to its name? Or is consensus in the right ballpark? That's my question. And are there any other meaningful gating events to unlock?

    來自SEB的Christopher Uhde。它基於 Calquence,並且還有成長空間。它最近又打出了不錯的成績。普遍預期 2026 年或 2025 年將成長約 10%,然後從那時到 2031 年左右再成長 10%,因此高峰將達到 44 億美元。那麼 AMPLIFY 是否名符其實呢?或者說,共識基本上是否正確?這就是我的問題。還有其他值得解鎖的重要關卡事件嗎?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • So thanks, Chris, for the question. AMPLIFY is very much an important part of the growth moving forward for Calquence and the fact that we've got positive study approval within Europe, and we're anticipating the US approval is important. In general, the desire that we're hearing among hematologists across the multiple malignancies that they treat is to move towards more finite based therapies. That trend has already happened within Europe. And we've got, I think, a very differentiated and strong profile to be able to compete against the existing venetoclax-based options that are available there.

    謝謝你的提問,克里斯。AMPLIFY 是 Calquence 未來發展的重要組成部分,我們在歐洲獲得了積極的研究批准,並且我們期待獲得美國的批准,這一點非常重要。總的來說,我們從血液科醫生那裡聽到的,他們治療的多種惡性腫瘤的共同願望是轉向基於更有限療效的療法。這種趨勢在歐洲已經出現。我認為,我們擁有非常獨特且強大的優勢,能夠與目前市場上現有的基於維奈托克的治療方案競爭。

  • In the US, remember that there is not a BCL2 and a BTKi combination finite CLL approach that's been approved. So we have an opportunity in the US to really be the first to come into this space and one in two patients are receiving finite as opposed to treat progression in the US So you can see how getting to growth numbers within the US, which is certainly the largest portion of our global Calquence sales really can be very, very meaningful. The other places in terms of opportunities, we have continued opportunity to expand Ecco in the second line MCL. And we also have DLBCL with ESCALADE which is something that will read out a little bit later on.

    在美國,請記住,目前還沒有獲得批准的 BCL2 和 BTKi 聯合治療有限 CLL 的方法。因此,我們有機會在美國真正成為第一個進入這個領域的公司,在美國,每兩名患者中就有一名接受的是有限治療,而不是治療病情進展。因此,你可以看出,在美國實現成長數字(這無疑是我們全球 Calquence 銷售額的最大部分)是多麼意義重大。就其他方面的機會而言,我們仍然有機會在第二線 MCL 中擴展 Ecco。我們還有 DLBCL 和 ESCALADE,稍後會詳細介紹。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • We need a microphone there.

    我們需要在那裡放置一個麥克風。

  • Justin Smith - Equity Analyst

    Justin Smith - Equity Analyst

  • Justin Smith from Bernstein. Sharon, one for you, if that's okay, cardiac transforms. Could you just remind us on the powering with regards to monotherapy versus combo with TAF. Is the TAF combo arm big enough to prove something clinically meaningful?

    來自伯恩斯坦的賈斯汀史密斯。莎倫,給你一個,如果可以的話,心臟改造。能否請您提醒我們一下,TAF 單藥治療與合併治療在療效上有何不同?TAF 合併治療組樣本數是否夠大,能夠證明一些具有臨床意義的結果?

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

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Right. So this question comes up a lot with Wainua. I think it really speaks to the interest in novel therapeutics for patients living with ATTR cardiomyopathy, which is a growing patient population as diagnostic rates improve. Now we have designed, as I mentioned earlier today, the largest ever cardiomyopathy study so that we would be powered to do preplanned subgroup analyses. One of those is to be able to differentiate between patients on baseline tafamidis versus those who are not. And our trial will have the largest proportion in number of patients who are on baseline tafamidis.

    正確的。所以這個問題常在Wainua被問到。我認為這充分體現了人們對治療 ATTR 心肌病變患者的新療法的興趣,隨著診斷率的提高,ATTR 心肌病變患者群體也在不斷增長。正如我今天早些時候提到的,我們已經設計了有史以來規模最大的心肌病變研究,以便我們能夠進行預先計劃的亞組分析。其中一項任務是能夠區分接受基線他法米地治療的患者和未接受基線他法米地治療的患者。在我們的試驗中,接受基線 tafamidis 治療的患者比例最高。

  • So should we be able to proceed through the statistical hierarchy? And answer that question, we have designed a trial that allows us specifically to get at that. And we think it's important because that's going to inform treatment guidelines for patients and help to shape the way cardiomyopathy patients are treated in the clinic. So we look forward to the readout of this in the second half of this year, and we'll share the data when they are mature.

    那我們是否能夠按照統計層級進行分析呢?回答這個問題,我們已經設計了一個試驗,可以專門用來解決這個問題。我們認為這很重要,因為這將為患者的治療指南提供信息,並有助於塑造臨床上治療心肌病變患者的方式。因此,我們期待在今年下半年看到相關結果,並在數據成熟後與大家分享。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Sharon. So we'll take Steve Scala's question online and then return to the room. I think Rajan has the microphone.

    謝謝你,莎倫。所以我們會先在線上解答史蒂夫·斯卡拉提出的問題,然後再回到會議室。我覺得拉詹手上有麥克風。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Pascal, a general question, but a hellaciously competitive market of undifferentiated products, which isn't growing very much despite huge awareness, doesn't strike me as the type of market AstraZeneca pursues aggressively. Obesity could be described as that, and you are not only involved but increased exposure. So what am I missing? Are you assuming that fundamentals improve that pricing stabilizes and increases, that strong growth will resume? I know that you're pursuing combos, but value-added products launched into a tough market would strike me as a high probability path to success. And if I could just tack on, can you shed light on why AstraZeneca continues to pursue an oral relaxant?

    Pascal,這是一個比較籠統的問題,但一個競爭異常激烈、產品同質化嚴重,儘管知名度很高但增長卻不多的市場,在我看來,這並非阿斯特捷利康積極追求的那種市場類型。肥胖可以被描述為這樣一種情況,而你不僅會受到影響,還會增加接觸這種影響的機會。那我到底錯過了什麼?您是否假設基本面會改善,價格會趨於穩定並上漲,強勁成長將會恢復?我知道你們正在追求組合產品,但我認為在競爭激烈的市場中推出增值產品才是通往成功的高機率途徑。如果可以的話,我想問一下,您能否解釋為什麼阿斯特捷利康公司要繼續研發口服肌肉鬆弛劑?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • I will only take the first one, if I may. It's an easy one, Ruud for you.

    如果可以的話,我只想要第一個。這很簡單,魯德,對你來說就對了。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • No, I think it's a fair question. First of all, I think we truly believe that the market in itself is still quite immature. Yes, injectables have their place. The first oral is moving in, but there's still so much improvement possible in combination therapies and for obesity overweighted people, I think, is very crucial in order to help those patients to reduce their risk of cardiovascular events. So that's one big ticket item.

    不,我認為這是個合理的問題。首先,我認為我們真心相信市場本身還相當不成熟。是的,注射劑也有其用途。第一種口服藥物正在研發中,但聯合療法還有很大的改進空間,我認為對於肥胖超重族群來說,聯合療法至關重要,有助於降低這些患者發生心血管事件的風險。所以這是一筆不小的開銷。

  • Second part is that those products are still not very much used in, let's say, the international markets. If you look at the success of Farxiga, a big part of the success of Farxiga across the three indications is that we have a very large footprint in the international markets. So there's clearly room to maneuver.

    第二點是,這些產品在國際市場上仍然沒有充分利用。如果你看看 Farxiga 的成功,Farxiga 在三個適應症上取得成功的一個重要原因是,我們在國際市場上擁有非常大的市場份額。所以顯然還有迴旋餘地。

  • The third piece is that we are doing a lot of research and development work regarding the quality of weight loss. Yes, it's not only about the percentage of weight loss, but also are you able to preserve lean muscle, yes or no? Are you able to attach or attack the bad fat, the visceral fat. So I think there are still an enormous amount of possibilities to move to the next generation of anti-obese medicines.

    第三點是,我們正在進行大量關於減肥品質的研究和開發工作。是的,這不僅關乎減重的百分比,還關乎你是否能夠維持肌肉量?你能攻擊或清除壞脂肪,也就是內臟脂肪嗎?所以我認為,在研發下一代抗肥胖藥物方面,仍然有很多可能性。

  • And I truly believe that AstraZeneca is one of those companies well equipped in order to address those questions. I think we have an excellent development and discovery team. You have seen our excitement of the deal we made last week with CSPC, which gives an opportunity to move in long-acting medicines. So I think there's still so much to win in this marketplace. And we are keen to play an important role in that.

    我真心相信,阿斯特捷利康是能夠很好地解決這些問題的公司之一。我認為我們擁有一支優秀的研發團隊。你們已經看到了我們上週與 CSPC 達成的協議所帶來的興奮之情,該協議為我們進軍長效藥物領域提供了機會。所以我認為,在這個市場上仍然有很多機會可以爭取。我們渴望在這方面發揮重要作用。

  • Rajan Sharma - Analyst

    Rajan Sharma - Analyst

  • It's Rajan Sharma from Goldman Sachs. I just wanted to focus on the growth drivers in 2026 outside of oncology. Do you think the biopharma business can grow through the Farxiga LOE? And then just thinking about the guidance for '26 at the group level, what has to go right to get to the upper end of that guidance? And when do we get visibility on those factors?

    我是高盛的拉詹·夏爾馬。我只想重點談談2026年除腫瘤學以外的成長驅動因素。您認為生物製藥業務能否透過 Farxiga LOE 成長?然後,再想想集團層級的 2026 年業績指引,要達到指引的上限,哪些方面必須進展順利?我們何時才能了解這些因素?

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yes. So let me take that question as a start. First of all, I think the respiratory and immunology portfolio is growing very fast. It was already $9 billion in the course of 2025. There's no reason to believe that products like Breztri potentially also with asthma or I said in my prepared remarks, product like Tezspire, Fasenra are not growing anymore double-digit moving forward. So that is, I think, a very important growth driver, not only in the United States and Europe, but also clearly in the international markets. So that's one big ticket item.

    是的。那麼,就讓我先回答這個問題吧。首先,我認為呼吸系統和免疫學產品組合成長非常迅速。到了 2025 年,這一數字已經達到 90 億美元。沒有理由相信像 Breztri 這樣的產品(也可能用於治療氣喘)或像我在準備好的演講稿中提到的 Tezspire、Fasenra 這樣的產品,未來不會再維持兩位數的成長。所以我認為這不僅在美國和歐洲,而且在國際市場上,都是一個非常重要的成長驅動因素。所以這是一筆不小的開銷。

  • The other one is clearly that hopefully, we will see the approval of baxdrostat in the course of this year as an approval that, of course, will not immediately generate substantial sales in the course of 2026. It's a highly dominated Part D population. But based on all the market research, we truly believe that this product has a multibillion-dollar opportunity as well. So if you see our internal forecast, yes, we will have a blip for sure regarding the Farxiga LOE but there are enough other growth drivers in order to compensate and potentially to exceed the growth moving forward. So we are quite bullish in our internal forecast regarding the forecast for the biopharma business.

    另一個顯而易見的希望是,我們希望今年能看到巴克司他獲得批准,當然,這項批准不會立即在 2026 年帶來實質的銷售額。這是以D部分(醫療保險繳費部分)為主的群體。但根據所有市場調查,我們堅信這款產品也蘊藏著數十億美元的商機。所以,如果你看看我們的內部預測,是的,Farxiga LOE 肯定會為我們帶來一些波動,但還有其他足夠的成長動力來彌補,並且有可能在未來實現超過預期的成長。因此,我們對生物製藥產業的前景非常樂觀。

  • Rajesh Kumar - Analyst

    Rajesh Kumar - Analyst

  • Rajesh Kumar from HSBC. Looking at 2026 you are sitting at 1.2 times net debt to EBITDA. You got consensus, which is inching by the minute close to your $80 billion target by 2030. You've got a few patent lifts soon after that. When you think of capital allocation, people have factored in a higher R&D in their models now. Would you go the organic route to basically support growth beyond 2030 or what sort of firepower do you intend to deploy for acquisitions?

    來自匯豐銀行的拉傑什·庫馬爾。展望 2026 年,您的淨債務與 EBITDA 比率為 1.2 倍。你們已經達成共識,正一步步接近你們到 2030 年實現 800 億美元的目標。之後不久你就會有幾台專利升降機。現在人們在考慮資本配置時,已經將更高的研發投入納入了他們的模型中。您打算採取有機成長的方式來支持 2030 年以後的成長,還是打算部署什麼樣的實力進行收購?

  • The question is basically underpinned by what Steve Scala was asking earlier that you've gone to obesity at a time where almost no one is sure whether this market has the same kind of growth. And every player is going in. So if you keep going organically into different segments, you might run out of idea. So how are you thinking about that problem in terms of reallocation of capital, share buyback or future investments?

    這個問題基本上源於史蒂夫·斯卡拉之前提出的問題,即你選擇在幾乎沒有人確定肥胖市場是否具有同樣增長潛力的時候談論肥胖問題。所有球員都將上場。所以,如果你繼續自然而然地進入不同的細分市場,你可能會江郎才盡。那麼,您是如何考慮這個問題的,例如重新配置資本、股票回購或未來投資?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So let me make a general comment, and then Aradhana can make more specific comments about capital allocation. One thing I would add to what Ruud said about oral GLP-1 and others is cardiometabolism is going to be -- is today the biggest issue mankind is facing. So -- and we are in the early phase of this transformation and the way we can actually tackle this disease, if you want. And beyond GLP-1, you also have SGLT2, and I really believe in the oral segment, combining those two is going to make a huge difference to how people are treated.

    那麼,我先發表一些總體看法,然後 Aradhana 可以就資本配置發表更具體的評論。關於魯德所說的口服 GLP-1 和其他藥物,我想補充一點:心血管代謝將是──也是當今人類面臨的最大問題。所以——我們正處於這種轉變的早期階段,以及我們實際上可以如何應對這種疾病的早期階段,如果你願意這麼說的話。除了 GLP-1 之外,還有 SGLT2,我真的相信在口服藥物領域,將這兩種藥物結合起來將會對人們的治療方式產生巨大的影響。

  • I think the foundation treatment of many of these people should be GLP-1 and an SGLT2, protect the kidneys, the heart, reduce weight, improve metabolic status. And then beyond that, we have other mechanisms, of course. So I think this is going to remain -- I mean, it is looking very crowded, but it is also a huge issue for medicine. And over time, I think things will settle down because not everybody will succeed in this market.

    我認為對許多這類患者來說,基礎治療應該是使用 GLP-1 和 SGLT2 受體激動劑,以保護腎臟、心臟,減輕體重,改善代謝狀況。當然,除此之外,我們還有其他機制。所以我認為這種情況會一直持續下去——我的意思是,現在看起來很擁擠,但這對醫學來說也是一個巨大的問題。隨著時間的推移,我認為情況會逐漸穩定下來,因為不是每個人都能在這個市場中取得成功。

  • We have the pipeline. We have the R&D strengths, in particular, development strengths, and we have the commercial network and the manufacturing network to manufacture those products and commercialize them around the world. So I think it will continue to -- it will be an important issue to tackle from a medical viewpoint, and it will be a driving growth for us -- a driver of growth, and we become profitable as soon as we can get to scale. In terms of a general question about capital allocation.

    我們有管道。我們擁有研發實力,特別是開發實力,我們擁有商業網絡和製造網絡,可以生產這些產品並將其推向世界各地。所以我認為它將繼續下去——從醫學角度來看,這將是一個需要解決的重要問題,它將成為我們成長的驅動力——一個成長的驅動力,一旦我們能夠達到規模,我們就能實現獲利。就資本配置這一一般性問題而言。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Yes. So a few things to clarify. So the $80 billion ambition was on an organic basis, and that does not assume any M&A of any size and scale. And I think we're on track to achieve that. We do have substantial firepower. I think we're very comfortable at 1.2 times leverage, but we have plenty of capacity. That being said, I think we remain very disciplined in terms of what type of assets we bring in because it's not about just buying assets. It's about actually creating value for shareholders from those assets that we acquire. And that requires substantial investments in R&D once we acquire those assets or license those assets, et cetera.

    是的。有幾點需要澄清。因此,800億美元的目標是在自然成長的基礎上實現的,並不包括任何規模的併購。我認為我們正朝著這個目標穩步前進。我們擁有強大的火力。我認為1.2倍的槓桿率對我們來說非常合適,而且我們還有充足的產能。話雖如此,我認為我們在引進資產類型方面仍然非常自律,因為這不僅僅是購買資產的問題。關鍵在於如何利用我們收購的資產為股東創造價值。一旦我們收購或取得這些資產的許可,就需要對研發進行大量投資等等。

  • And so again, we are very disciplined in how we do that, and we need to continue to add value. I think on your question of beyond 2030, that's why Pascal highlighted all -- I mean, if you look at our R&D expense, a substantial portion of that, I wouldn't say, the majority, but a substantial portion is going actually in assets, which won't have any substantial revenue in 2030. So that's all the investment for the beyond 2030 to continue the growth rates because we know in that time frame, there are going to be substantial LOEs.

    所以,我們在這方面非常嚴謹,而且我們需要繼續創造價值。我認為,關於您提出的 2030 年以後的問題,這就是 Pascal 強調所有——我的意思是,如果您看一下我們的研發支出,其中相當一部分,我不會說是大部分,但相當一部分實際上是投入到資產中,而這些資產在 2030 年不會產生任何實質性的收入。所以,這就是 2030 年以後為維持成長速度所需的所有投資,因為我們知道,在那個時間段內,將會出現大量的 LOE(支出減少)。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • If you look at it, I mean, we are in a good position. We don't have to go after Phase III assets that are proven in cost of fortune and you pay front which you're going to get later. We really try to focus our BD activities on earlier assets where we can add value and create shareholder value because we don't need products immediately. We need to invest for the future.

    你看,我們現在處境不錯。我們不必去追求那些成本高昂、需要預付費用但以後才能收回成本的第三階段資產。我們努力將業務拓展活動集中在早期資產上,因為我們不需要立即推出產品,而早期資產可以為我們創造價值和股東價值。我們需要為未來投資。

  • And so our strategy really has been to build our pipeline, of course, and add to it, but through earlier BD investments and then add value over time. So that's really our strategy. And as you said, we have a good capacity in terms of raising debt if we wanted to. But we also have to absorb all these products in our P&L, right? So it's not only a question of cash, a question of P&L, too, and a question of focus. We have a very broad portfolio. But within this, we need to stay focused on what our key priorities are.

    因此,我們的策略實際上是建立我們的產品線,當然,並透過早期的業務拓展投資來增加產品線的價值,然後隨著時間的推移增加價值。這就是我們的策略。正如你所說,如果我們想的話,我們有很強的舉債能力。但是,我們也必須將所有這些產品計入我們的損益表,對吧?所以這不僅是現金問題,也是損益問題,更是關注重點的問題。我們的產品組合非常廣泛。但在這個過程中,我們需要始終專注於我們的關鍵優先事項。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • There's one online.

    網路上有一個。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Sorry, online, that's what you mean, I'm sorry. Over to you Peter Verdult.

    抱歉,你是說線上交流,我很抱歉。接下來輪到彼得·維杜爾特了。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Peter Verdult here from BNP. Sorry, I can't be with you live. Just two quick ones, please, Susan and Sharon. For Susan on Alteogen. Can we have an update here and your confidence in this formulation technology significantly extending your key oncology biologic franchises? Are there any products you can call out that will be leading the charge or entering the clinic in the next 12 months?

    我是來自英國國家黨的彼得‧弗杜爾特。抱歉,我不能和你一起現場觀看。蘇珊和莎倫,就兩個問題,拜託了。致蘇珊,關於Alteogen。能否提供一些最新進展,以及您對這項製劑技術能否顯著擴展貴公司在腫瘤生物製劑領域的核心產品線的信心?您能否重點推薦一些將在未來 12 個月內引領潮流或進入臨床應用的產品?

  • Secondly, for Sharon, sorry to do (inaudible) But can I just try my luck. Can you sketch out in a little more detail what Astra would consider a win given existing silence data in the market? So put simply, do you think you can raise the bar further on outcomes in the silence market?

    其次,對於莎倫,很抱歉(聽不清楚),但我可以試試運氣嗎?根據目前市場上的沉默數據,您能否更詳細地概述一下阿斯特捷利康認為怎樣的結果才算成功?簡而言之,你認為在靜音市場中,你還能進一步提高結果的標準嗎?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Can we focus on the first question? And if we have time, we will return to the second one later.

    我們能先集中討論第一個問題嗎?如果時間允許,我們稍後會再討論第二個問題。

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

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

  • So obviously, I think subcutaneous formulations have the opportunity to offer convenience to patients, which I think is very attractive. And we're obviously investing in this across our immuno-oncology portfolio, the bispecifics and and Imfinzi to look at. But also we have the opportunity to look at subcutaneous formulations also with our ADC portfolio, which is perhaps slightly more surprising to people, but it is possible to do that in certain circumstances.

    所以很明顯,我認為皮下製劑有機會為患者提供便利,我認為這非常有吸引力。顯然,我們正在對免疫腫瘤產品組合進行投資,包括雙特異性抗體和 Imfinzi 等。但我們也有機會利用我們的 ADC 產品組合來研究皮下製劑,這或許會讓一些人感到有些意外,但在某些情況下是可以做到的。

  • And then, of course, across our T-cell engagers, the actual doses in the T-cell engager portfolio are often low enough that, that enables a subcutaneous formulation without necessarily requiring something like the hyaluronidase technology as well. So I would just say that this is a trend that you've seen already across multiple different settings and is one that I think will continue to grow across the biologics part of the portfolio.

    當然,在我們所有的 T 細胞接合劑中,T 細胞接合劑產品組合中的實際劑量通常都很低,因此可以採用皮下製劑,而無需像透明質酸酶技術那樣的其他技術。因此,我想說的是,這種趨勢已經在多種不同的環境中出現,我認為這種趨勢將在生物製劑產品組合中繼續發展。

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

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Sure. So going back to CARDIO-TTRansform for eplontersen. A few things to note about our clinical trial relative to competitors' clinical trial. The first is that the key objective of CARDIO-TTRansform was to have a balance of naive patients and defamitive patients. And given that CARDIO-TTRansform is the largest ever trial run in this setting, we've achieved that. So we'll be able to address that question pending positive results, which we think will be very informative to the clinical community.

    當然。所以,回到 eplontersen 的 CARDIO-TTRansform。與競爭對手的臨床試驗相比,我們的臨床試驗有幾點需要注意。首先,CARDIO-TTRansform 的主要目標是平衡初次接受治療的患者和有誹謗經歷的患者。鑑於 CARDIO-TTRansform 是迄今為止在此環境下規模最大的試驗,我們已經實現了這一目標。所以,在獲得正面結果後,我們將能夠回答這個問題,我們認為這將對臨床界非常有幫助。

  • And the second is that CARDIO-TTRansform allows for stabilizer drop in, so acoramidis drop-ins, which speaks to the remaining unmet medical need. We know that patients who are currently on stabilizers continue to progress on therapy. If that were not true, we wouldn't be able to enroll our trial. So understanding how those patients are succeeding on a silencer on top of their standard of care, including a stabilizer is incredibly important.

    其次,CARDIO-TTRansform 允許穩定劑插入,例如 acoramidis 插入,這說明了仍然存在的未滿足的醫療需求。我們知道,目前正在接受穩定劑治療的患者在治療過程中會持續取得進展。如果不是這樣,我們就無法進行試驗招募。因此,了解這些患者如何在接受包括穩定器在內的標準治療的基礎上,透過加用消音器而取得成功,是非常重要的。

  • It's also important to note that in this larger trial, we have specific hard cardiac endpoints, including cardiovascular mortality as opposed to all-cause mortality, which really helps us understand how this drug is doing what it's doing and how it ultimately impacts those important readouts for patients who are living with ATTR cardiomyopathy. So overall, we expect to have landmark data for overall benefit and be able to demonstrate the additive benefit of a silencer on top of stabilizers.

    值得注意的是,在這項更大規模的試驗中,我們有具體的硬性心臟終點,包括心血管死亡率,而不是全因死亡率,這確實有助於我們了解這種藥物是如何發揮作用的,以及它最終如何影響患有 ATTR 心肌病變的患者的這些重要指標。因此,總的來說,我們期望獲得具有里程碑意義的整體效益數據,並能夠證明在穩定器的基礎上增加消音器的附加效益。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So maybe we take the last one. Mattias Haggblom at Handelsbanken.

    所以,或許我們可以選最後一個。德國商業銀行的 Mattias Haggblom。

  • Mattias Haggblom - Analyst

    Mattias Haggblom - Analyst

  • I'm curious to hear how you think about the AstraZeneca's competitive advantage from an in-license or M&A point of view given you have two [science] sites in China when committing for assets with a competitor who does not have R&D on site in China.

    我很想知道,從引進或併購的角度來看,考慮到阿斯特捷利康在中國擁有兩個(科學研究)基地,而競爭對手在中國沒有研發基地,您如何看待阿斯特捷利康的競爭優勢。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So the first part of your question was a bit hard to understand, but I think you're asking us about our position in China from a BD viewpoint. If that's the question, let me try and I'm absolutely convinced we need to be in China to collaborate with, partner with Chinese companies but also to compete and learn -- learn to compete with them and how they compete, not only commercially, but mostly from an R&D perspective because the world has changed and they are increasingly becoming a fundamental part of innovation in our industry and some of them at some point will become global companies. So it's fundamental for us to be there.

    所以你問題的第一部分有點難以理解,但我認為你是在從業務拓展的角度詢問我們在中國的地位。如果這是你的問題,讓我來試試回答。我堅信我們需要在中國與中國公司合作、建立夥伴關係,同時也要與他們競爭和學習——學習如何與他們競爭,以及他們是如何競爭的,不僅是在商業方面,更重要的是在研發方面,因為世界已經改變,他們正日益成為我們行業創新的重要組成部分,其中一些公司在某個時候會發展成為全球性公司。所以對我們來說,到場至關重要。

  • And I think we have quite a good position to do this. We have two R&D centers. We have a strong position, strong profile in China. A few of the deals we've made -- we were able to make because people wanted to work with us. With -- the recent deal we made, I know that someone else wanted to pay more money. But the company wanted to work with us. So I think that relationship we build with local Chinese companies over time and our reputation and our focus and the focus they know that we have on a few limited diseases have really helped us secure a number of deals over the last few years.

    我認為我們在這方面處於相當有利的地位。我們有兩個研發中心。我們在中國擁有強大的市場地位和知名度。我們達成的一些交易——之所以能夠達成,是因為有人願意與我們合作。根據我們最近達成的交易,我知道其他人想出更高的價格。但該公司想和我們合作。所以我認為,隨著時間的推移,我們與中國本土企業建立的關係,以及我們的聲譽和專注度,還有他們所了解的我們專注於少數幾種疾病,確實幫助我們在過去幾年裡達成了許多交易。

  • Now what happens, though, is the cost, the price -- the price of these BD deals is going up, right? And that's -- I assume that would be the case. And that's why after COVID and when the contrary we opened, we quickly went down. We've done quite a number of deals over the last few years at reasonable prices and it's becoming more difficult because everybody is going there. But yes, I continue to think we have a good position. We can leverage our position in China, but we will have to remain disciplined because there's competition for this and the prices are going up. And of course, we have to stay focused on what we're doing.

    但是,現在的問題是成本,也就是價格──這些BD交易的價格正在上漲,對吧?我想應該是這樣。這就是為什麼在新冠疫情之後,當我們反其道而行重新開放時,我們的業績迅速下滑。過去幾年,我們以合理的價格完成了不少交易,但現在越來越難了,因為大家都湧向那裡。但是,我仍然認為我們處於有利地位。我們可以利用我們在中國的地位,但我們必須保持自律,因為這方面存在競爭,而且價格正在上漲。當然,我們也要專注於我們正在做的事情。

  • So Andy, I think we have to stop here. Some of us have to be on the road show. So thank you so much for all your interest and your great questions. Have a good rest of the day.

    安迪,我想我們得就此打住了。我們當中有些人必須參加巡迴演出。非常感謝大家的注意與提出的精彩問題。祝你今天餘下的時間過得愉快。