AstraZeneca PLC (AZN) 2026 Q3 法說會逐字稿

內容摘要

  1. 摘要
    • 本季總營收成長 7%,核心 EPS 成長 14%;Oncology、Rare Disease、R&I 皆雙位數成長,抵銷 Farxiga、Brilinta 專利到期衝擊
    • 重申全年指引:營收預計中高個位數百分比成長,核心 EPS 低雙位數百分比成長;宣布三年 Reshaping for Sustainable Growth 計畫,預計產生 $15 億年化節省,並再投資於研發
    • 市場反應未明確揭露,但管理層強調 12 項 Phase III 正面數據、4 款新藥核准,2027 年將有 20+ 項關鍵 readout,對 2030 與長期成長信心提升
  2. 成長動能 & 風險
    • 成長動能:
      • Oncology、Rare Disease、R&I 事業群持續雙位數成長,產品組合多元且地區分布廣泛
      • 12 項 Phase III 正面 readout,4 款新藥核准,推動未來營收增長
      • Tagrisso、Imfinzi、Enhertu 等核心產品持續擴大適應症與市場滲透率
      • 深厚後期研發管線,2027 年預計有 20+ 項高價值 readout,9 款潛在新藥 pivotal data
      • 積極投資 ADC、細胞治療、雙特異性抗體、體重管理等新技術平台,布局 2030 年後成長
    • 風險:
      • Farxiga、Brilinta、SYMBICORT 等產品專利到期與中國 VBP(帶量採購)壓力
      • 中國本地競爭者崛起,部分產品面臨價格與市場競爭壓力
      • 新藥上市初期需投入大量資源,短期內對獲利貢獻有限
      • 歐洲、日本等地區創新藥物定價與報銷環境仍具不確定性
  3. 核心 KPI / 事業群
    • Oncology 營收:前九月成長 16% 至 $21.9 億,Q3 成長 17%
    • Tagrisso Q3 營收 $21 億,年增 12%,首次突破 $20 億大關
    • Imfinzi/Imjudo Q3 合計營收超過 $20 億,分別年增 26%/25%
    • Calquence Q3 營收 $11 億,年增 16%,持續領先 BTK 抑制劑市場
    • Enhertu Q3 營收 $9.69 億,年增 35%,美國成長近 50%
    • R&I(呼吸與免疫)Q3 營收 $25 億,年增 11%;FASENRA 年增 14%,Tezspire 年增 51%,BREZTRI 年增 14%
    • CVRM(心血管/腎臟/代謝)Q3 營收 $26 億,年減 18%;Farxiga 年減 23%
    • Rare Disease 前九月營收 $75 億,年增 11%;ULTOMIRIS Q3 年增 19%,STRENSIQ 年增 34%
  4. 財務預測
    • 全年營收預估中高個位數百分比成長,核心 EPS 低雙位數百分比成長(重申指引)
    • 核心毛利率前三季 83%,全年預期穩定或略高於 2025 年
    • 全年 CapEx 預估較 2025 年成長低雙位數百分比,主因部分專案延至 2027 年
  5. 法人 Q&A
    • Q: Datroway 等新藥在未來營收中的占比?癌症疫苗策略會以合作還是自研為主?
      A: Datroway 是重要產品但非唯一主力,營收分布多元且風險調整保守。癌症疫苗目前以內部開發為主,未來會有更多資訊公布。
    • Q: Reshaping for Sustainable Growth 計畫細節?$20 億成本為現金還是非現金?
      A: 計畫涵蓋多面向(臨床試驗布局、技術投資等),非單一事業群,$20 億主要為現金成本,節省資源將再投資於未來成長。
    • Q: R&D 費用明年是否加速成長?中長期毛利率展望?
      A: R&D 支出會隨新藥推進而波動,明年具體指引將於明年 2 月公布。會持續投資 pipeline,同時維持營運槓桿與成本紀律。
    • Q: Imfinzi 皮下注射版上市時機?中國生技政策對公司影響?
      A: Imfinzi 皮下注射版預計在 IV 劑型專利到期前上市,將提升競爭力。中國政策有利創新與知識產權保護,雖競爭加劇但公司具備合作與競爭優勢,整體影響偏中性至正面。
    • Q: Baxfendy、Etcamah、Tozorakimab 等新藥明年營收貢獻與獲利結構?
      A: Baxfendy、Tozorakimab 等新藥上市初期以商業保險為主,Medicare 覆蓋需等至 2028 年,短期內需投入資源,獲利貢獻需數年。部分產品可利用現有銷售團隊,部分新領域需額外投資。

完整原文

使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Welcome to AstraZeneca's nine months and Q3 2026 webinar for investors and analysts. Before handing over to AstraZeneca, I'd like to read the Safe Harbor Statement. The company intends to utilize the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995.

    歡迎參加阿斯特捷利康(AstraZeneca)2026年前九個月及第三季投資人與分析師網路研討會。在交由阿斯特捷利康團隊開始之前,我想先宣讀「安全港聲明」。本公司擬依據《1995年美國私人證券訴訟改革法》(United States Private Securities Litigation Reform Act of 1995)之安全港條款行事。

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

    本次電話會議的與會者可能會就阿斯特捷利康的營運與財務表現作出前瞻性陳述。雖然我們相信相關預期係基於合理假設,但前瞻性陳述本質上涉及風險與不確定性,且可能受各種因素影響,致使實際結果與該等陳述所明示或暗示者出現重大差異。於本次電話會議中所作之任何前瞻性陳述,均反映會議當時可得之知識與資訊。本公司不承擔更新該等陳述之任何義務。

  • Please carefully review the forward-looking statements disclaimer in the slide deck accompanying this presentation and webinar. There will be an opportunity to ask questions after today's presentation. If you would like to ask a question please use the 'raise hand' feature at any time during the call. With that, I'd now like to hand the conference over to the company. Thank you.

    請仔細閱讀隨本次簡報與網路研討會提供之投影片資料中的前瞻性陳述免責聲明。今日簡報結束後將提供提問機會。如欲提問,請於會議期間任何時間使用「舉手」功能。接下來,我將把會議交由公司方進行。謝謝。

  • Joris Silon - Head of Investor Relations

    Joris Silon - Head of Investor Relations

  • A warm welcome to AstraZeneca's nine-month and third-quarter 2026 presentation conference call and webcast for investors and analysts. I'm Joris Silon, Head of Investor Relations, and before I hand over to Pascal and members of our executive team, I would like to cover some housekeeping items. All of the materials presented today are available on our AstraZeneca Investor Relations website. Next slide, please.

    誠摯歡迎各位參加阿斯特捷利康2026年前九個月及第三季面向投資人與分析師的簡報電話會議與網路直播。我是投資人關係主管Joris Silon。在我把時間交給Pascal及我們的執行團隊成員之前,我先說明幾項會議事項。今日所呈現的所有資料均可於阿斯特捷利康投資人關係網站取得。請切換到下一張投影片。

  • This slide contains our forward-looking statements, including the Safe Harbor provisions, which I would encourage you to take the time to read. We will be making comments on our performance using constant exchange rates, or CER, for financial numbers and other non-GAAP measures. A non-GAAP to GAAP reconciliation is contained within the results announcement. All numbers quoted are in millions of US dollars unless stated otherwise.

    本頁包含我們的前瞻性陳述(含安全港條款),建議各位撥冗閱讀。我們將以固定匯率(constant exchange rates,CER)口徑,以及其他非GAAP衡量指標,評論我們的業績表現與財務數字。非GAAP與GAAP之調節表載於本次業績公告中。除非另有說明,所有引用數字之單位均為百萬美元。

  • Next slide, please. This slide shows our agenda for today's call. Following our prepared remarks, we will open the line for questions, and as usual, we will try to address as many questions as we can during the allocated time. Please limit the number of questions you ask to allow others a fair chance to participate in the Q&A. With that, please advance to the next slide, and Pascal, over to you.

    請切換到下一張投影片。本頁顯示今日會議議程。在我們的預先準備發言之後,將開放提問;如同往常,我們會在既定時間內盡可能回答更多問題。為讓其他與會者也有公平參與問答的機會,請限制提問數量。接下來請切換到下一張投影片,Pascal,交給你。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Joris, and welcome, everybody. Next slide, please. I'm pleased to report that our strong growth momentum and pipeline delivery have continued through the first nine months of 2026. This reflects the progress we're making across our strategic priorities, and above all, the focus and the commitment of teams across our company.

    謝謝你,Joris,也歡迎各位。請切換到下一張投影片。我很高興報告,我們強勁的成長動能與研發管線交付成果在2026年前九個月持續延續。這反映我們在各項策略優先事項上的進展,更重要的是,來自全公司團隊的專注與投入。

  • Total revenue grew 7% and core EPS increased 14%. Excluding Farxiga and Brilinta, total revenue grew 12%, demonstrating the underlying strength of our broad portfolio. Since our full-year results in February, we've announced positive results from 12 Phase III programs, and we've achieved first approvals for four new medicines, including Adakama in the US. This brings our total number of approved new molecular entities to 14, as we progress towards our goal of delivering 20 new medicines by 2030.

    總營收成長7%,核心每股盈餘(core EPS)增加14%。若排除Farxiga與Brilinta,總營收成長12%,顯示我們多元產品組合的基本面實力。自2月公布全年業績以來,我們已宣布12項第三期(Phase III)計畫的正面結果,並取得4款新藥的首次核准上市,其中包括Adakama在美國的核准。這使我們已核准的新分子實體(new molecular entities)總數達到14項,並持續朝2030年前推出20款新藥的目標邁進。

  • We've also presented positive Phase III data for three new molecular entities, tozorakimab in COPD, efzimfotase alfa in HPP, and Sone-Ve, our first wholly owned ADC, including claudin 18.2-positive gastric cancer. With commercial momentum continuing and a deep late-stage pipeline advancing, we are increasingly confident in our ability to deliver our 2030 ambition, as well as sustainable long-term growth through the next decade. Next slide, please. Our strong performance is underpinned by the breadth of our therapy areas and our geographical footprint.

    我們也公布了3項新分子實體的正面第三期數據:tozorakimab用於COPD、efzimfotase alfa用於HPP,以及Sone-Ve(我們首款完全自有的ADC),涵蓋claudin 18.2陽性的胃癌。隨著商業動能持續、後期研發管線深厚且不斷推進,我們對於實現2030年願景,以及在未來十年達成可持續的長期成長,愈發有信心。請切換到下一張投影片。我們的強勁表現,來自於治療領域的廣度以及全球布局的支撐。

  • In the first nine months, Oncology, Rare Disease, and R&I all delivered double-digit growth. Together, they more than offset the expected headwinds we've seen from the loss of exclusivity of Farxiga and Brilinta in CVRM. We've also delivered robust growth across the US, Europe, and the emerging markets outside of China. In China, growth continued to be impacted by volume-based procurement.

    在前九個月中,腫瘤、罕見疾病與R&I均實現雙位數成長。合計而言,這些成長不僅抵銷了我們在CVRM領域因Farxiga與Brilinta喪失專利獨占(loss of exclusivity)所面臨的預期逆風,且我們在美國、歐洲以及中國以外的新興市場也交出穩健成長。在中國,成長仍持續受到帶量採購的影響。

  • But excluding this impact, China grew 13%, with growth across all therapy areas. Next slide, please. Over the first nine months of the year, we saw positive results from 12 important Phase III programs. Let me say a couple of words about some of these.

    但若排除該影響,中國業務成長13%,且各治療領域均有成長。請切換到下一張投影片。在今年前九個月,我們在12項重要的第三期計畫中看到正面結果。我想就其中幾項補充說明。

  • Tozorakimab has enormous potential, and we are now developing it beyond COPD. Volrustomig again is a blockbuster opportunity. I also want to come back on the Tagrisso franchise. A few years ago, we were told Tagrisso was going to be challenged by the launch of competitor regimens. Look at what we've done. The combination with Orpathys has the potential to drive both broader first-line use as well as longer Tagrisso-based treatment duration, keeping patients on Tagrisso rather than switching them off, and therefore protecting the franchise from newcomers. We have really made tremendous progress with Tagrisso. VOLGA is another example of building the Imfinzi franchise.

    Tozorakimab具備極大的潛力,我們目前也正將其開發拓展至COPD以外的適應症。Volrustomig同樣具備成為重磅產品(blockbuster)的機會。我也想再談談Tagrisso產品系列。幾年前,有人告訴我們Tagrisso將會受到競品療法上市的挑戰。看看我們做到了什麼。與Orpathys的合併治療有望推動更廣泛的一線使用,同時延長以Tagrisso為基礎的治療期間,讓病人持續使用Tagrisso而非轉換用藥,從而保護該產品系列免受新進者衝擊。我們在Tagrisso上確實取得了巨大的進展。VOLGA則是打造Imfinzi產品系列的另一個例子。

  • Lastly, efzimfotase alfa and Sone-Ve could both become $3 billion-$5 billion products, depending on the type of label we get. You can see that we have added quite a number of substantial opportunities to our growth potential. Together, this positive readout represents more than $10 billion in non-risk-adjusted peak year sales potential, maintaining the scale of opportunity we outlined at the start of the year. And importantly, with the positive data in hand, much of the risk behind these opportunities has now been removed.

    最後,efzimfotase alfa與Sone-Ve兩者皆可能成為30億至50億美元級別的產品,取決於我們取得的適應症標示(label)類型。各位可以看到,我們已為成長潛力新增了相當多具規模的機會。綜合而言,這些正面讀出所代表的未經風險調整(non-risk-adjusted)峰值年度銷售潛力超過100億美元,維持了我們在年初所提出的機會規模。更重要的是,在取得正面數據後,這些機會背後的多數風險如今已被移除。

  • This shows the strength and diversification of our pipeline and underpins our confidence in achieving our $80 billion ambition by 2030. As I will show you next, the platforms and technologies we are investing in today position us to keep growing well beyond that. Next slide, please. This quarter, we announced an equity investment in Summit Therapeutics, together with clinical collaborations to combine ivonescimab with Sone-Ve and Datroway, and plans to broaden our collaborations further.

    這展現了我們研發管線的實力與多元化,並支撐我們對於在2030年前達成800億美元願景的信心。正如我接下來將展示的,我們今日所投資的平台與技術,將使我們在此之後仍能持續強勁成長。請切換到下一張投影片。本季我們宣布對Summit Therapeutics進行股權投資,並展開臨床合作,將ivonescimab與Sone-Ve及Datroway進行合併治療研究,同時也規劃進一步擴大合作。

  • Under the terms of the agreement, each company will contribute their respective medicine for the planned combination trials and jointly contribute to trial costs. Ivo is the leading PD-1/VEGF bispecific, a class we expect to play a role in selected tumor types. It complements our own IO bispecifics, rilvegostomig and volrustomig, which we continue to progress at pace. This is an example of how we are maximizing the value of our rapidly growing ADC portfolio.

    依協議條款,雙方將各自提供其藥物用於規劃中的合併試驗,並共同分攤試驗成本。Ivo是領先的PD-1/VEGF雙特異性抗體(bispecific),我們預期此類別將在特定腫瘤類型中扮演角色。它可與我們自有的IO雙特異性抗體rilvegostomig與volrustomig形成互補,而我們也正持續加速推進這兩項計畫。這是我們如何最大化快速成長之ADC產品組合價值的例子。

  • We believe ADCs will become the backbone of treatment across tumor types, and this partnership gives flexibility to combine them with the optimal next-generation immuno-Oncology partner for each setting. This collaboration strengthens the core pillar of our Oncology vision, building novel combinations, and is of strategic benefit to the companies involved. We look forward to updating you as these programs progress. Next slide, please.

    我們相信ADC將成為跨腫瘤類型治療的骨幹,而此合作夥伴關係讓我們能更具彈性地在不同情境下,為ADC搭配最適合的下一代免疫腫瘤(immuno-Oncology)合作夥伴。此合作強化了我們腫瘤願景的核心支柱——打造創新合併療法——並對參與公司具有策略性效益。隨著這些計畫推進,我們期待向各位更新進展。請切換到下一張投影片。

  • Turning now to the longer term, our ambition is to keep growing well past 2030, and that is why we are investing today in the technologies we believe will change how a wide range of diseases are treated in the future. Across five platforms, the first nine months of 2026 have brought significant progress. Starting with weight management and cardiovascular risk factors, we expect the first Phase III data for laroprovstat in the first half of 2027. We now have Phase III trials ongoing for elecoglipron, and we've initiated Phase III trials for our respective, our selective, sorry, amylin receptor agonist, lenbelintide.

    現在轉向較長期的展望,我們的抱負是在 2030 年之後仍持續強勁成長,這也是為什麼我們今天投資於我們相信將在未來改變多種疾病治療方式的技術。在五大平台上,2026 年前九個月已帶來顯著進展。先從體重管理與心血管風險因子開始,我們預期 laroprovstat 的首批第三期數據將於 2027 年上半年公布。我們目前已有 elecoglipron 的第三期試驗在進行中,並已啟動我們各自的、我們的選擇性——抱歉——胰淀素受體致效劑 lenbelintide 的第三期試驗。

  • In ADCs and radioconjugates, progress has been strong. Clarity-Gastric01 delivered an unprecedented overall survival benefit for sonesitatug vedotin second line and later gastric cancer. We expect the first Phase III data for our second wholly owned ADC, puxitatug samrotecan, in the second half of 2027, and we initiated three Phase III trials for torvutatug samrotecan this year. The Summit collaboration I described previously is another way we are maximizing the ADC opportunity.

    在 ADC 與放射性偶聯藥物方面,進展強勁。Clarity-Gastric01 為 sonesitatug vedotin 用於二線及後線胃癌帶來前所未有的整體存活期(OS)獲益。我們預期第二個完全自有的 ADC——puxitatug samrotecan——的首批第三期數據將於 2027 年下半年公布,且我們今年已為 torvutatug samrotecan 啟動三項第三期試驗。我先前提到的 Summit 合作,也是我們最大化 ADC 機會的另一種方式。

  • For our next generation immuno-Oncology bispecifics, we now have 15 Phase III trials across nine tumor types, six of which combine our bispecifics with our ADCs. We expect the first Phase III readouts for rilvegostomig and volrustomig in the second half of 2027. Our cell therapy and T-cell engager portfolios are also advancing. We have three ongoing Phase III trials of AZD0120 in multiple myeloma, and two Phase III trials of surovatamig are progressing in B-cell lymphomas.

    就我們下一代免疫腫瘤(immuno-Oncology)雙特異性抗體而言,我們目前在九種腫瘤類型中共有 15 項第三期試驗,其中 6 項將我們的雙特異性抗體與我們的 ADC 聯合使用。我們預期 rilvegostomig 與 volrustomig 的首批第三期讀出將於 2027 年下半年公布。我們的細胞治療與 T 細胞接合器產品組合也在推進。我們在多發性骨髓瘤中有三項 AZD0120 的第三期試驗正在進行,且 surovatamig 的兩項第三期試驗也正在 B 細胞淋巴瘤中推進。

  • Both platforms have been extended into autoimmune diseases, with early trials underway, underscoring their broader therapeutic potential. Beyond these lead programs, we have four further clinical stage cell therapies and four additional T-cell engagers in early development, which will help us reach more patients across more disease areas. Together, these programs form a deep late-stage pipeline of multi-blockbuster opportunities that will underpin our next wave of growth. You can expect a steady flow of news, with more than 20 key Phase III readouts planned for 2027.

    兩個平台也已延伸至自體免疫疾病,早期試驗正在進行中,凸顯其更廣泛的治療潛力。除這些領先計畫之外,我們還有另外四項臨床階段的細胞治療,以及四項額外的 T 細胞接合器處於早期開發,將協助我們在更多疾病領域觸及更多病患。綜合而言,這些計畫構成一個深厚的後期研發管線,具備多個「重磅藥」機會,將支撐我們下一波成長。您可以期待穩定的消息流,因為我們規劃在 2027 年有超過 20 項關鍵第三期讀出。

  • I will say more about this when I close. With that, I will hand over to Aradhana to take you through our financials. Please move to the next slide. Thank you.

    我在結語時會再多談一些。接下來我把時間交給 Aradhana,帶各位看我們的財務表現。請切到下一張投影片。謝謝。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Thank you, Pascal, and good morning, good afternoon, everyone. As usual, I will start with our reported P&L. Next slide, please. As Pascal highlighted, we delivered continued top-line momentum in the first nine months of the year. Total revenue increased by 7%, with product revenue up 6%. Alliance revenue increased by 32%, driven by higher profit sales from our partnered medicines in Enhertu, Datroway, and Tezspire in markets where our partners record product sales.

    謝謝你,Pascal,各位早安、午安。照例,我先從我們揭露的損益表(P&L)開始。請下一張。如 Pascal 所強調,我們在今年前九個月持續展現營收動能。總營收成長 7%,其中產品營收成長 6%。聯盟營收成長 32%,主要受惠於我們合作藥品 Enhertu、Datroway 與 Tezspire 在由合作夥伴認列產品銷售的市場中,帶來更高的分潤銷售(profit sales)。

  • Next slide, please. Turning to the core P&L. Core gross margin was 83% in the first nine months. As we indicated previously, we expect gross margin in the second half to be below the first half, reflecting the seasonal demand profile of lower-margin medicines such as FluMist and Beyfortus. We also expect to see the usual year-end impact of hospital budget capping and NRDL stock compensation in China in the fourth quarter. For the full year, we continue to expect core gross margins to be stable to slightly higher than in 2025.

    請下一張。接著看核心損益表。前九個月核心毛利率為 83%。如我們先前所指出,我們預期下半年毛利率將低於上半年,反映 FluMist 與 Beyfortus 等較低毛利藥品的季節性需求型態。我們也預期在第四季會看到一如往常的年末影響,包括醫院預算封頂,以及中國 NRDL 備貨補償。就全年而言,我們仍預期核心毛利率將較 2025 年持平至略為提高。

  • Core R&D expense increased by 5% year to date, reflecting continued investment in the pipeline. R&D represented 23% of total revenue in the first nine months, and we continue to expect it to be at the upper end of the low 20s percentage range for the full year. We are continuing to invest behind the opportunities that drive long-term growth, including bispecifics, cell therapies, and T-cell engagers, along with our ongoing investment in weight management and cardiovascular outcome trials.

    核心研發費用(R&D)年初至今增加 5%,反映我們持續投資於研發管線。前九個月研發費用占總營收 23%,我們仍預期全年將落在 20% 出頭區間的上緣。我們持續加碼投資於推動長期成長的機會,包括雙特異性抗體、細胞治療與 T 細胞接合器,同時也持續投資於體重管理與心血管結局試驗。

  • Core SG&A expense increased by 4% year-to-date. This reflects the investment behind the US launch of Baxfendy, preparations for the anticipated launch of tozorakimab next year, and investment behind the launches of the 47 major market regulatory approvals received since the full-year results in February. Overall, core operating expenses increased by 5% in the first nine months. As in prior years, we expect a sequential step-up in the fourth quarter versus third quarter in operating expenses. Other operating income was $618 million for the first nine months, including $277 million in the third quarter.

    核心銷售、一般及行政費用(SG&A)年初至今增加 4%。這反映我們對 Baxfendy 在美國上市的投入、為預期明年上市的 tozorakimab 所做的準備,以及對自 2 月全年業績公布以來所取得的 47 項主要市場監管核准之上市推動投入。整體而言,前九個月核心營運費用增加 5%。與往年相同,我們預期第四季相較第三季營運費用將呈現季增。前九個月其他營運收入為 6.18 億美元,其中第三季為 2.77 億美元。

  • This includes the sale of Zoryve royalties for $100 million. We expect the other operating income in the second half of the year to be slightly higher than the first half. The core tax rate was 19% year to date, consistent with our full year expected range of 18%-22%. Core EPS grew by 14% in the first nine months.

    其中包括以 1 億美元出售 Zoryve 權利金。我們預期下半年其他營運收入將略高於上半年。年初至今核心稅率為 19%,與我們全年預期的 18%–22% 區間一致。前九個月核心每股盈餘(EPS)成長 14%。

  • Next slide, please. Turning to cash flow and the balance sheet. Cash flow from operating activities was $10.9 billion in the first nine months, lower than in the comparative period. There are two principal factors behind that. First, the prior year period benefited from the Lynparza milestone receipt in Q1 2025. Second, we have experienced working capital effects associated with the US loss of exclusivity for Farxiga. As previously indicated, we expect these working capital effects to persist through the remainder of the year before normalizing.

    請下一張。接著看現金流與資產負債表。前九個月營運活動現金流為 109 億美元,低於比較期間。背後主要有兩個因素。第一,去年同期受惠於 2025 年第一季收到 Lynparza 的里程碑款。第二,我們因 Farxiga 在美國喪失獨占權而出現與營運資金相關的影響。如先前所述,我們預期這些營運資金影響將持續到今年剩餘期間,之後才會正常化。

  • Capital expenditure was $2.3 billion in the period, and we now expect full-year CapEx to increase by low teens percentage compared to 2025.This is a change from prior indication, driven as a result of some project starts now moving into 2027. Deal-related payments totaled $4.3 billion in the first nine months. This includes the $600 million upfront payment for the Dizal collaboration, which closed during the third quarter, and other new deals during the year. Milestone payments relating to prior BD transactions amounted to around $2 billion in the first nine months, and we continue to expect this to be approximately $2.5 billion for the full year.

    本期間資本支出(CapEx)為 23 億美元,我們目前預期全年 CapEx 將較 2025 年以低十位數百分比成長。這與先前指引不同,主要是因為部分專案啟動時點現已移至 2027 年。前九個月與交易相關的付款合計 43 億美元。其中包括第三季完成交割的 Dizal 合作案 6 億美元預付款,以及年度內其他新交易。與先前商務開發(BD)交易相關的里程碑付款,前九個月約為 20 億美元;我們仍預期全年約為 25 億美元。

  • This number does not include the $2 billion Summit equity investment, which closed this month. We expect finance expenses to be higher in the fourth quarter than in the third quarter, as this will include higher interest costs for the bonds issued in the third quarter, as well as lease expenses following the opening of our new Kendall Square R&D center, where we are today. Fourth-quarter finance expenses will also include a one-time expense relating to the premium paid for the Summit equity investment. Importantly, we remain comfortable with our current level of gross debt, and our current net debt-to-EBITDA ratio is at 1.2 times.

    此數字不包含本月完成交割的 20 億美元 Summit 股權投資。我們預期第四季財務費用將高於第三季,因為其中將包含第三季發行債券所帶來較高的利息成本,以及我們新的 Kendall Square 研發中心(我們今天所在之處)啟用後的租賃費用。第四季財務費用也將包含一筆一次性費用,與為 Summit 股權投資所支付的溢價相關。重要的是,我們對目前的總負債水準仍感到安心,而我們目前的淨負債對 EBITDA 比率為 1.2 倍。

  • Finally, we are reiterating our full-year guidance. We continue to expect total revenue to increase by a mid-to-high single-digit percentage and core EPS to increase by a low double-digit percentage. Today, we are also announcing the Reshaping for Sustainable Growth program, a three-year initiative to redeploy resources and strengthen capabilities across AstraZeneca's existing businesses and therapy areas. This program is expected to incur up to $2 billion in one-time restructuring costs and deliver $1.5 billion in annualized pre-tax run rate benefits.

    最後,我們重申我們的全年指引。我們仍預期總營收將以中至高個位數百分比成長,核心每股盈餘(core EPS)將以低雙位數百分比成長。今天,我們也宣布「重塑以實現永續成長」(Reshaping for Sustainable Growth)計畫,這是一項為期三年的倡議,旨在於阿斯特捷利康(AstraZeneca)既有業務與治療領域間重新配置資源並強化能力。預期該計畫將產生最高達20億美元的一次性重組成本,並帶來每年15億美元(年化、稅前)的經常性效益(run rate benefits)。

  • The savings from this program will continue to be reinvested back into the company, essentially in our pipeline. We expect activities to be completed by the end of 2029. To summarize, we have delivered another strong quarter with continued momentum across our portfolio and new launches. At the same time, we're investing in the pipeline, manufacturing capacity, and BD opportunities that we believe can support sustainable growth through the next decade while maintaining a strong balance sheet.

    該計畫所節省的成本將持續再投資回公司,主要投入於我們的研發管線。我們預期相關活動將於2029年底前完成。總結而言,我們再度交出強勁的一季,產品組合與新上市產品持續展現動能。同時,我們也投資於研發管線、製造產能與商業發展(BD)機會;我們相信這些投資可在維持強健資產負債表的同時,支持未來十年的永續成長。

  • With that, I'll hand over to Dave to take you through the performance of our Oncology business. Next slide, please.

    接下來,我把時間交給Dave,帶各位回顧我們腫瘤業務的表現。請到下一張投影片。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thank you, Aradhana. Next slide, please. Oncology total revenues grew 16% in the first nine months to $21.9 billion, with an impressive 17% growth in the business in the third quarter. During the first nine months, we saw double-digit growth across all major regions.

    謝謝你,Aradhana。請到下一張投影片。腫瘤業務在前九個月的總營收成長16%至219億美元,第三季業務成長更達到亮眼的17%。在前九個月期間,我們在所有主要地區都看到雙位數成長。

  • The US, in particular, delivered strong year-over-year growth of 18%, demonstrating robust demand across our key brands, with Europe and emerging markets delivering mid-teens growth. Turning now to the quarterly performance of our key medicines. Tagrisso delivered revenues of $2.1 billion in the third quarter, surpassing the $2 billion mark for the first time, representing 12% growth on the prior year. Demand was broad-based across indications and regions, reinforcing Tagrisso's role as the backbone of care for EGFR-mutated lung cancer.

    尤其是美國,年對年成長18%,顯示我們關鍵品牌需求強勁;歐洲與新興市場則呈現中十位數成長。接著看我們關鍵藥品的季度表現。Tagrisso第三季營收達21億美元,首次突破20億美元門檻,較去年同期成長12%。需求在各適應症與各地區均衡成長,進一步鞏固Tagrisso作為EGFR突變肺癌照護基石的地位。

  • We continue to see increasing adoption of combination regimens in the first line, with FLAURA2 maintaining its leadership position in all major markets. We anticipate continued growth across all indications through the remainder of the year. This was another exceptional quarter for our IO franchise, with Imfinzi and Imjudo delivering growth of 26% and 25%, respectively, with combined revenues exceeding $2 billion for the first time. As in previous quarters, growth was broad-based, with contributions from established indications and recent launches.

    我們持續看到第一線治療中合併療法的採用率提升,且FLAURA2在所有主要市場維持領先地位。我們預期今年剩餘期間,各適應症將持續成長。我們的免疫腫瘤(IO)產品線本季同樣表現卓越,Imfinzi與Imjudo分別成長26%與25%,合計營收首次突破20億美元。如同前幾季,成長動能廣泛,既有適應症與近期上市產品皆有貢獻。

  • VOLGA, which is currently under priority review in the US, will further expand the reach of Imfinzi in the increasingly competitive muscle-invasive bladder cancer setting, and continued demand across indications positions us well to sustain this growth through year-end. Calquence is now the leading BTK inhibitor in the first-line CLL across the top eight markets, with total revenues increasing by 16% to $1.1 billion in the third quarter. In the US, we're seeing an increasing adoption of the fixed-duration AMPLIFY regimen following its launch earlier this year, and uptake is rapidly expanding in major markets ex-US With ongoing global readouts, we expect continued growth across key markets for the remainder of the year.

    VOLGA目前在美國處於優先審查(priority review)中,將進一步擴大Imfinzi在競爭日益激烈的肌層浸潤性膀胱癌治療領域的覆蓋範圍;同時,各適應症的持續需求也使我們有利於在年底前維持此成長。Calquence目前已成為前八大市場中第一線慢性淋巴性白血病(CLL)的領先BTK抑制劑,第三季總營收成長16%至11億美元。在美國,我們看到今年稍早上市的固定療程(fixed-duration)AMPLIFY方案採用率持續上升;在美國以外的主要市場,滲透也正快速擴大。隨著全球持續公布讀出結果(readouts),我們預期今年剩餘期間在關鍵市場將持續成長。

  • Enhertu revenues grew 35% in the quarter to $969 million. While performance was broad-based across regions, growth in the US was particularly notable at nearly 50%, driven by demand in the established breast cancer indications, as well as meaningful contributions from DESTINY-Breast09 in first-line HER2-positive disease, where nearly four in 10 patients are receiving Enhertu, and the two early breast indications, DESTINY-Breast05 and DESTINY-Breast11. In the high-risk post-neoadjuvant setting, Enhertu is already establishing a leadership position with DESTINY-Breast05. Strong growth of 40% in the emerging markets was driven by new launches and expanded access for existing indications.

    Enhertu本季營收成長35%至9.69億美元。雖然各地區表現普遍強勁,但美國成長尤其顯著,接近50%,主要由既有乳癌適應症需求帶動;此外,DESTINY-Breast09在第一線HER2陽性疾病中亦有實質貢獻,近四成患者正在使用Enhertu;以及兩個早期乳癌適應症DESTINY-Breast05與DESTINY-Breast11。在高風險新輔助治療後(post-neoadjuvant)情境中,Enhertu已透過DESTINY-Breast05建立領先地位。新興市場40%的強勁成長,則由新上市與既有適應症擴大可近性所驅動。

  • We expect continued growth for Enhertu through year-end. Truqap revenues grew 9% in the quarter to $210 million. As highlighted previously, the AKT PTEN biomarker altered population is fully penetrated in the US, with launches in developed and emerging markets driving growth for the brand overall. US demand growth in the quarter was offset by unfavorable inventory movements resulting from the transition from bottles to blister packs.

    我們預期Enhertu在年底前將持續成長。Truqap本季營收成長9%至2.10億美元。如先前所述,在美國,AKT PTEN生物標記變異族群已完全滲透;而在已開發與新興市場的上市推進,帶動品牌整體成長。本季美國需求成長,受到由瓶裝轉換為鋁箔泡殼包裝(blister packs)所致的不利庫存變動所抵銷。

  • We are seeing early positive signals from the launch in prostate cancer and are working to establish PTEN IHC testing to bring Truqap to patients who may benefit. Datroway revenues reached $78 million in the third quarter. This reflects further uptake in late-line EGFR-mutated lung cancer, with Datroway maintaining a leadership position in the fragmented third-line plus setting. In breast cancer, we are seeing continued uptake in the hormone receptor-positive setting and a strong launch in the recently approved first-line triple-negative indication based on the compelling and differentiated results seen in TROPION-Breast02.

    我們在前列腺癌上市初期已看到正向訊號,並正致力建立PTEN IHC檢測,以將Truqap帶給可能受益的患者。Datroway第三季營收達7,800萬美元。這反映其在晚線EGFR突變肺癌中的進一步採用,且Datroway在分散的第三線以上治療市場中維持領先地位。在乳癌方面,我們看到其在荷爾蒙受體陽性族群持續擴大使用;並且基於TROPION-Breast02所呈現具說服力且具差異化的結果,在近期核准的第一線三陰性適應症上也有強勁的上市表現。

  • We are also seeing encouraging early signals for Etcamah, following the US launch for SERENA-6 in September. These include strong willingness among HCPs to test during the first-line treatment, alongside increasing test readiness and testing volumes. Finally, we were pleased to report our first revenues for Zegfrovy in the third quarter. Earlier this month, we launched this medicine in the United States for patients with previously treated non-small cell lung cancer with an EGFR exon 20 insertion mutation.

    此外,Etcamah在9月於美國針對SERENA-6上市後,我們也看到令人鼓舞的早期訊號。包括醫療照護專業人員(HCPs)在第一線治療期間進行檢測的高度意願,以及檢測準備度與檢測量的提升。最後,我們很高興在第三季首次確認Zegfrovy的營收。本月稍早,我們已在美國推出此藥物,用於先前已接受治療、且帶有EGFR第20外顯子插入突變的非小細胞肺癌患者。

  • This launch marks an important step as we bring this oral treatment to a patient population with substantial unmet need while further building on our leadership in EGFR lung cancer. With strong momentum demonstrated across our portfolio in the first nine months, we are well-positioned for continued growth through the year-end as we deliver innovative Oncology medicines to more patients. With that, please advance to the next slide, and I will pass over to Susan to cover key R&D highlights from the quarter.

    此次上市是重要的一步:我們將此口服治療帶給一個仍有重大未被滿足需求的患者族群,同時進一步鞏固我們在EGFR肺癌領域的領導地位。在前九個月我們的產品組合展現強勁動能之下,我們已具備良好條件在年底前持續成長,並將創新腫瘤藥物帶給更多患者。接下來請到下一張投影片,我將把時間交給Susan,說明本季研發(R&D)重點。

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

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

  • Thank you, Dave. It has been an exceptional few months for our Oncology pipeline. Across the World Conference on Lung Cancer last month and ESMO just a few days ago, we shared more than 140 abstracts, including 38 oral presentations, and five of our Phase III readouts were presented in presidential symposia across these two congresses. These datasets mark significant progress against our strategy to redefine cancer care, intervening at earlier stages of the disease, transforming outcomes through powerful new combinations, and using novel ADCs to replace chemotherapy as the backbone of treatment.

    謝謝你,Dave。過去幾個月對我們的腫瘤研發管線而言表現極為出色。在上個月的世界肺癌大會(World Conference on Lung Cancer)以及幾天前的ESMO上,我們分享了超過140篇摘要,其中包含38場口頭報告;並且在這兩場大會的主席級專題(presidential symposia)中,發表了我們5項第三期(Phase III)讀出結果。這些資料集代表我們在「重新定義癌症照護」策略上的重大進展:在疾病更早期介入、透過強效新型合併療法改善治療結果,以及運用新型ADC取代化療作為治療基石。

  • Starting in EGFR-mutated lung cancer, we presented two key Phase III datasets. Firstly, SAFFRON, which addresses a significant unmet need for the one in three patients with MET amplification and/or overexpression following progression on Tagrisso. In these patients, adding Orpathys to Tagrisso reduced the risk of death by 32% versus platinum-based chemotherapy, extending median overall survival by nearly five months. SAFFRON is the first global Phase III trial to show both a significant progression-free survival and overall survival benefit in this setting, and it does so with a biomarker-directed all-oral regimen.

    從EGFR突變肺癌開始,我們發表了兩項關鍵的第三期資料集。首先是SAFFRON,針對在Tagrisso治療後疾病進展、且約三分之一患者具有MET擴增與/或過度表現的重大未被滿足需求。在這些患者中,將Orpathys加入Tagrisso,相較於含鉑化療可將死亡風險降低32%,並將中位總生存期延長近5個月。SAFFRON是首個全球第三期試驗,在此治療情境中同時顯示具統計顯著的無惡化存活期(PFS)與總生存期(OS)獲益,且採用以生物標記導向的全口服治療方案。

  • Importantly, it also demonstrates the benefit of continuing Tagrisso beyond progression in these selected patients, creating a treatment pathway across first and second line that further strengthens Tagrisso's leadership. Secondly, SANOVO, which brings Orpathys plus Tagrisso into the first-line setting for patients with MET overexpression at diagnosis, a selected and well-defined subgroup with poor prognosis. In this trial, the combination extended median progression-free survival to more than two years compared to just over one year with Tagrisso alone, which demonstrates the poor prognosis of this patient population. We also saw an encouraging 9.6-month improvement in median overall survival, highlighting the value of this combination upfront.

    重要的是,這也展示了在這些經篩選的患者中於疾病進展後仍持續使用 Tagrisso 的益處,建立起橫跨第一線與第二線的治療路徑,進一步鞏固 Tagrisso 的領導地位。第二,SANOVO 將 Orpathys 加上 Tagrisso 帶入第一線治療,用於在診斷時即出現 MET 過度表現的患者;這是一個經選擇且定義明確、預後不佳的亞族群。在此試驗中,該組合將中位無進展存活期延長至兩年以上,相較之下 Tagrisso 單藥僅略高於一年,這也凸顯了此患者族群的預後不佳。我們亦觀察到中位總存活期有令人鼓舞的 9.6 個月改善,突顯此組合在前線使用的價值。

  • Together, these trials reinforce Tagrisso as the backbone therapy in EGFR-mutated lung cancer, on top of which we can build combinations, both in biomarker-selected patients, as with Orpathys, and in broader populations, as previously demonstrated with FLAURA2. We are excited to build on this further with the TROPION-Lung14 and 15 trials, which look at combining Datroway with Tagrisso in the first and second-line settings. Also in lung cancer, DESTINY-Lung04 marks the first Phase III trial to demonstrate improved progression-free survival versus the global first-line standard of care, pembrolizumab plus doublet chemotherapy in HER2-mutant non-small cell lung cancer.

    綜合而言,這些試驗強化了 Tagrisso 作為 EGFR 突變肺癌的骨幹治療;在此基礎上,我們可建立各種聯合療法,既可用於生物標記物篩選的患者(如搭配 Orpathys),也可用於更廣泛的人群(如先前 FLAURA2 所示)。我們很期待在 TROPION-Lung14 與 15 試驗中進一步推進,這些試驗評估在第一線與第二線治療情境下將 Datroway 與 Tagrisso 聯合使用。同樣在肺癌領域,DESTINY-Lung04 是首個第三期試驗,證實在 HER2 突變非小細胞肺癌中,相較於全球第一線標準治療(pembrolizumab 加雙藥化療)可改善無進展存活期。

  • Enhertu delivered a median progression-free survival of 14.3 months and an objective response rate of 70%, underscoring the potential of moving Enhertu earlier to the time of metastatic diagnosis when treatment has the greatest opportunity to improve outcomes.

    Enhertu 的中位無進展存活期為 14.3 個月,客觀緩解率為 70%,凸顯將 Enhertu 前移至轉移性診斷時點的潛力,因為在該時點治療最有機會改善結局。

  • Turning now to small cell lung cancer. DeLLphi-305 evaluated Imfinzi plus IMDELLTRA as first-line maintenance in extensive stage disease following Imfinzi-based induction. The combination reduced the risk of death by 58% versus Imfinzi alone, with a median overall survival of 21.1 months, the longest ever reported in a Phase III trial in this setting. Imfinzi is the only immunotherapy to demonstrate a significant survival benefit in both limited and extensive stage small cell lung cancer, and DeLLphi-305 reinforces Imfinzi as the backbone IO across this disease.

    接著談小細胞肺癌。DeLLphi-305 評估在以 Imfinzi 為基礎的誘導治療後,於廣泛期疾病中以 Imfinzi 加 IMDELLTRA 作為第一線維持治療。相較於 Imfinzi 單藥,該組合將死亡風險降低 58%,中位總存活期達 21.1 個月,為此治療情境下第三期試驗迄今報告的最長紀錄。Imfinzi 是唯一在侷限期與廣泛期小細胞肺癌中皆證實具有顯著存活獲益的免疫治療,而 DeLLphi-305 進一步鞏固 Imfinzi 作為此疾病全程的骨幹免疫腫瘤(IO)治療。

  • Next, in bladder cancer, VOLGA is the first trial of perioperative immunotherapy with enfortumab vedotin given only before surgery in patients with muscle-invasive bladder cancer who are not candidates for or have declined cisplatin. This regimen reduced the risk of recurrence, progression, or death by 49%, and the risk of death by 42%, with nearly four in five patients alive at two years. Limiting enfortumab vedotin to the neoadjuvant setting makes this an optimized, cytotoxic-sparing regimen. VOLGA is now under priority review in the US.

    接下來在膀胱癌方面,VOLGA 是首個圍手術期免疫治療試驗:僅在手術前給予 enfortumab vedotin,用於不適合或拒絕使用順鉑的肌層浸潤性膀胱癌患者。此方案將復發、進展或死亡風險降低 49%,並將死亡風險降低 42%,兩年時仍存活的患者接近五分之四。將 enfortumab vedotin 限定於新輔助治療階段,使其成為一個經最佳化、可減少細胞毒性治療負擔的方案。VOLGA 目前在美國正接受優先審查。

  • Together with NIAGARA and POTOMAC, this trial reinforces Imfinzi as the immunotherapy backbone across bladder cancer. As a reminder, we see bladder cancer as an overall blockbuster opportunity for Imfinzi. Finally, in gastric cancer, CLARITY-Gastric01 evaluated Sone-Ve in patients with previously treated claudin 18.2-positive advanced gastric cancer, and is the first global Phase III trial to show an overall survival benefit with a claudin 18.2-targeted ADC in this setting. In third-line and later-stage patients, Sone-Ve reduced the risk of death by 53%, doubling median overall survival from 5 to 10 months.

    連同 NIAGARA 與 POTOMAC,這項試驗進一步強化 Imfinzi 作為膀胱癌領域的免疫治療骨幹。提醒一下,我們將膀胱癌視為 Imfinzi 整體上具備「重磅」潛力的機會。最後在胃癌方面,CLARITY-Gastric01 評估 Sone-Ve 用於既往治療過的 claudin 18.2 陽性晚期胃癌患者,並且是首個全球第三期試驗,在此治療情境下證實 claudin 18.2 標靶 ADC 可帶來總存活期獲益。在第三線及更後線患者中,Sone-Ve 將死亡風險降低 53%,使中位總存活期由 5 個月倍增至 10 個月。

  • Sone-Ve also reduced the risk of death by 42% in the broader second-line-plus population. Importantly, the benefit was consistent across claudin 18.2 expression levels down to 25%, a much lower threshold than other claudin 18.2-targeted therapies, meaning Sone-Ve could benefit approximately 60% of patients in this setting. We see significant further potential for Sone-Ve. We have already initiated CLARITY-Gastric02 in the first-line setting and are exploring the opportunity for Sone-Ve in biliary tract and pancreatic cancers.

    在更廣泛的第二線及以上人群中,Sone-Ve 亦將死亡風險降低 42%。重要的是,其獲益在 claudin 18.2 表現量低至 25% 的各表現層級中皆一致;此門檻遠低於其他 claudin 18.2 標靶治療,意味著在此治療情境下,Sone-Ve 可能可惠及約 60% 的患者。我們認為 Sone-Ve 仍有顯著的進一步潛力。我們已在第一線治療情境啟動 CLARITY-Gastric02,並正探索 Sone-Ve 在膽道與胰臟癌中的機會。

  • As Pascal mentioned earlier, we recently announced an exciting clinical collaboration with Summit Therapeutics to evaluate Sone-Ve in combination with ivonescimab, a first-in-class PD-1/VEGF bispecific in gastrointestinal cancers, with trials expected to begin imminently. Taken together, these datasets demonstrate the depth of our Oncology pipeline, and with further readouts to come, we are confident that Oncology will continue to drive AstraZeneca's growth through 2030 and well beyond. With that, please advance to the next slide, and I will pass over to Ruud to cover BioPharmaceuticals performance.

    如 Pascal 先前提到,我們近期宣布與 Summit Therapeutics 展開令人振奮的臨床合作,評估 Sone-Ve 與 ivonescimab 的聯合使用;ivonescimab 為同類首創的 PD-1/VEGF 雙特異性抗體,適用於胃腸道癌症,相關試驗預期將於近期啟動。綜合而言,這些數據展現了我們腫瘤產品線的深度;隨著後續更多讀出即將到來,我們有信心腫瘤事業將持續推動阿斯特捷利康至 2030 年及更長遠的成長。接下來請切換到下一張投影片,我將交由 Ruud 介紹生物製藥事業的表現。

  • Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

  • Thanks, Susan. Next slide, please. Our BioPharmaceuticals business continues to navigate a period of transition, with strong growth from our Respiratory & Immunology portfolio offsetting much of the anticipated headwinds for Farxiga, Brilinta, and Roxadustat in CVRM. Overall, BioPharmaceuticals total revenue declined by 6% in the quarter to $5.6 billion.

    謝謝,Susan。請下一張投影片。我們的生物製藥事業持續處於轉型期;呼吸與免疫(R&I)產品組合的強勁成長,抵銷了 CVRM 領域 Farxiga、Brilinta 與 Roxadustat 所面臨的大部分預期逆風。整體而言,本季生物製藥總營收年減 6%,至 56 億美元。

  • R&I delivered another strong quarter, with total revenue increasing by 11% to $2.5 billion, driven by continued momentum across our key growth medicines. FASENRA grew 14% to $602 million, with particularly strong growth in emerging markets, driven by FASENRA's inclusion on the National Reimbursement Drug List in China earlier this year. The clinical reach of FASENRA has continued to broaden, with the four major market approvals for hypereosinophilic syndrome in the second quarter. Tezspire maintained its impressive momentum, growing 51% to $429 million, with strong performance across all regions.

    R&I 再度交出強勁的一季,總營收年增 11% 至 25 億美元,主要受我們關鍵成長藥物持續動能帶動。FASENRA 成長 14% 至 6.02 億美元,新興市場成長尤為強勁,主要受惠於 FASENRA 今年稍早納入中國國家醫保藥品目錄。FASENRA 的臨床適用範圍持續擴大,第二季在四大主要市場取得嗜酸性粒細胞增多症候群的核准。Tezspire 維持亮眼動能,成長 51% 至 4.29 億美元,各區域表現皆強勁。

  • Growth was driven by the expanded use of biologics in severe asthma and the launch of Tezspire in chronic rhinosinusitis with nasal polyps. The growing body of evidence supporting Tezspire's differentiated mechanism of action was further strengthened in the quarter by the positive readout from the CROSSING trial in eosinophilic esophagitis. BREZTRI increased 14% to $374 million, with a particularly strong performance in emerging markets as growth accelerated in China. The BREZTRI opportunity has broadened beyond COPD, with recent approvals in asthma, and that indication has seen rapid uptake in the United States since it launched in July.

    成長動能來自重度氣喘中生物製劑使用的擴大,以及 Tezspire 於伴鼻息肉的慢性鼻竇炎適應症的上市。支持 Tezspire 差異化作用機轉的證據體系持續累積,本季 CROSSING 試驗在嗜酸性食道炎的正向讀出,進一步強化了這一點。BREZTRI 成長 14% 至 3.74 億美元,新興市場表現尤為強勁,因中國成長加速。BREZTRI 的機會已從 COPD 擴展至更廣範圍,近期亦取得氣喘適應症核准;自 7 月在美國上市以來,該適應症已快速放量。

  • Saphnelo also continued its strong trajectory, increasing 32% to $235 million. Growth was supported by the recent launches of Saphnelo's subcutaneous formulation in the US, Europe, and Japan. In the next 12 months, we have readouts anticipated for three additional indications: lupus nephritis, systemic sclerosis, and cutaneous lupus erythematosus. The strong performances from key respiratory medicines more than offset an 11% decline for SYMBICORT, which generated $660 million in the quarter.

    Saphnelo 亦延續強勁走勢,成長 32% 至 2.35 億美元。成長受惠於 Saphnelo 皮下劑型近期在美國、歐洲與日本上市。未來 12 個月內,我們預期將有另外三個適應症的讀出:狼瘡腎炎、系統性硬化症,以及皮膚型紅斑性狼瘡。關鍵呼吸系藥物的強勁表現,已足以抵銷 SYMBICORT 本季 11% 的下滑;SYMBICORT 本季營收為 6.60 億美元。

  • This reflected a 25% decline in the US following the entry of a second generic competitor, while China continued to deliver growth. Turning to CVRM, total revenue declined by 18% to $2.6 billion, reflecting the anticipated loss of exclusivity headwinds. Farxiga declined 23% to $1.6 billion, reflecting loss of exclusivity in the US and the impact of VBP in China. Demand remained strong in both Europe and established rest of the world, both of which grew double digits.

    這反映美國在第二個學名藥競爭者進入後下滑 25%,而中國則持續帶來成長。轉向 CVRM,總營收年減 18% 至 26 億美元,反映預期中的獨占權到期(LOE)逆風。Farxiga 下滑 23% 至 16 億美元,反映其在美國的獨占權到期,以及中國 VBP 的影響。歐洲與已開發市場的其他地區需求仍然強勁,兩者皆呈現雙位數成長。

  • The launch of Baxfendy is progressing to plan, with revenue of $9 million in the quarter. We are pleased with the uptake so far, with a good balance of prescriptions from primary and specialty care, and across resistant and uncontrolled patients. For the next few quarters, we expect the majority of Baxfendy's revenue to come from commercial customers as we continue to build access ahead of anticipated Medicare Part D reimbursement in 2028. We are also progressing our early launch preparations for tozorakimab.

    Baxfendy 的上市推進符合計畫,本季營收為 900 萬美元。我們對目前的採用情況感到滿意,處方來源在基層醫療與專科照護之間取得良好平衡,且涵蓋抗藥性與控制不佳的患者。在接下來幾季,我們預期 Baxfendy 的大部分營收將來自商業客戶,因我們將持續在預期 2028 年 Medicare Part D 給付前建立可近性。我們也正在推進 tozorakimab 的早期上市準備工作。

  • Currently anticipate US launch in the first quarter of 2027, subject to regulatory approval. The initial focus will be on commercially insured and Medicare Part B patients, but as COPD tends to affect older patients, we hope to see the first Medicare Part D reimbursement during the course of 2028. We are encouraged by the sustained growth of our R&I portfolio and the opportunities ahead from new indications and launches. Finally, we are looking forward to an exciting year for the CVRM portfolio in 2027, with readouts anticipated for three NMEs, balci/dapa, zibo/dapa, and laroprovstat, and the first life cycle management opportunity for Baxfendy in primary aldosteronism.

    目前預期在 2027 年第一季於美國上市,惟仍須取得監管核准。初期重點將放在商業保險與 Medicare Part B 患者;但由於 COPD 往往影響年長患者,我們希望在 2028 年期間看到首次 Medicare Part D 給付。我們對 R&I 產品組合的持續成長,以及新適應症與新上市所帶來的前景機會感到鼓舞。最後,我們也期待 2027 年 CVRM 產品組合將迎來令人振奮的一年,預計將有三項 NME(balci/dapa、zibo/dapa 與 laroprovstat)的讀出結果,以及 Baxfendy 在原發性醛固酮增多症上的首個生命週期管理機會。

  • I will now hand over to Sharon to take us through the latest developments in the BioPharmaceuticals R&D pipeline.

    接下來我將交給 Sharon,帶領我們了解生物製藥研發管線的最新進展。

  • Sharon Barr - Executive Vice President - Bio Pharmaceuticals Research and Development

    Sharon Barr - Executive Vice President - Bio Pharmaceuticals Research and Development

  • Thank you, Ruud. Next slide, please. At the European Respiratory Society Congress in September, we presented results from the Phase III OBERON and TITANIA studies for tozorakimab in COPD. These data reinforce our confidence in tozorakimab as a $5 billion-plus asset.

    謝謝你,Ruud。請看下一張投影片。在 9 月的歐洲呼吸學會年會上,我們發表了 tozorakimab 用於 COPD 的第三期 OBERON 與 TITANIA 研究結果。這些數據進一步強化我們對 tozorakimab 作為一項年銷售額 50 億美元以上資產的信心。

  • Tozorakimab was studied in the broadest COPD population evaluated for a biologic to date, spanning the full range of eosinophil levels and lung function severity, broader than the population studied for currently approved biologics. We saw clinically meaningful reductions in exacerbations across eosinophil levels. The reduction was 23% in patients with baseline eosinophil counts below 150 cells per microliter, 34% in those with counts of 150 or higher, and 43% in those with counts of 300 or higher. Importantly, the 23% reduction was observed in a population for which no biologic is currently approved.

    截至目前,tozorakimab 的研究涵蓋了生物製劑所評估過最廣泛的 COPD 人群,橫跨嗜酸性球水平與肺功能嚴重度的完整範圍,且比目前已核准生物製劑所研究的人群更廣。我們觀察到在各嗜酸性球水平下,急性惡化均有具臨床意義的降低。在基線嗜酸性球計數低於每微升 150 個細胞的患者中降低 23%;在計數為 150 或以上者降低 34%;在計數為 300 或以上者降低 43%。重要的是,23% 的降低出現在目前尚無任何生物製劑獲准適用的人群中。

  • Overall, these results demonstrate highly clinically meaningful efficacy across a broad COPD population, with reductions in exacerbations of up to 34% in former smokers and up to 30% in the overall population. In addition to these data for tozorakimab, earlier this month at United European Gastroenterology Week, we presented Phase III data from the CROSSING trial of Tezspire in eosinophilic esophagitis. The prevalence of EoE has increased nearly fivefold since 2009, and nearly half a million patients are affected in the US alone. Despite available first-line therapies and dietary interventions, nearly 50% of patients continue to experience significant disease burden.

    整體而言,這些結果顯示在廣泛的 COPD 人群中具有高度且具臨床意義的療效:在既往吸菸者中急性惡化最多降低 34%,在整體人群中最多降低 30%。除 tozorakimab 的數據外,本月稍早在 United European Gastroenterology Week 上,我們也發表了 Tezspire 用於嗜酸性食道炎(EoE)的第三期 CROSSING 試驗數據。自 2009 年以來,EoE 的盛行率幾乎增加了五倍,僅在美國就有近 50 萬名患者受影響。儘管已有第一線治療與飲食介入,仍有近 50% 的患者持續承受顯著的疾病負擔。

  • This includes difficulty swallowing and a substantial impact on quality of life. CROSSING evaluated two doses of Tezspire, 210 milligrams and 420 milligrams every four weeks, in adults and adolescents with EoE. At week 24, both doses delivered statistically significant and clinically meaningful improvements on the co-primary endpoints of histologic remission and the frequency and severity of difficulty swallowing. Importantly, these improvements were sustained through week 52, marking the first time a biologic has demonstrated this durability in a placebo-controlled trial.

    這包括吞嚥困難,並對生活品質造成重大影響。CROSSING 在成人與青少年 EoE 患者中評估了 Tezspire 兩種劑量:每四週 210 毫克與 420 毫克。在第 24 週,兩種劑量在共同主要終點——組織學緩解,以及吞嚥困難的頻率與嚴重度——均達到統計顯著且具臨床意義的改善。重要的是,這些改善可持續至第 52 週,這標誌著生物製劑首次在安慰劑對照試驗中展現出如此持久的效果。

  • In key secondary endpoints, Tezspire also demonstrated statistically significant improvements in endoscopic features of EoE, and approximately a third of patients achieved total endoscopic remission. These data contribute to our belief that Tezspire has multi-blockbuster potential across multiple indications. Beyond these two important readouts, I would like to highlight several additional advances across our BioPharmaceuticals pipeline during the third quarter. In dyslipidemia, we expect initial Phase III results for laroprovstat monotherapy in the first half of 2027.

    在關鍵次要終點方面,Tezspire 亦在 EoE 的內視鏡特徵上展現統計顯著的改善,且約三分之一的患者達到完全內視鏡緩解。這些數據支持我們相信 Tezspire 在多個適應症上具備多重「超級重磅」潛力。除了這兩項重要讀出之外,我也想強調第三季我們生物製藥管線的其他幾項進展。在血脂異常方面,我們預期 laroprovstat 單藥治療的第三期初步結果將於 2027 年上半年出爐。

  • We also expect results in 2027 from the first two Phase III trials of the laroprovstat rosuvastatin fixed-dose combination. These trials include both patients receiving background lipid-lowering therapy and treatment-naive patients. Within weight management, we have now dosed patients in 10 ongoing Phase III trials with elecoglipron. We have also dosed the first patients in three Phase III trials for lenbelintide, formerly known as AZD6234, which is our selective amylin receptor agonist.

    我們也預期在 2027 年取得 laroprovstat/rosuvastatin 固定劑量複方的前兩項第三期試驗結果。這些試驗納入了同時接受背景降脂治療的患者,以及未曾接受治療的患者。在體重管理方面,我們已在 10 項進行中的 elecoglipron 第三期試驗中完成患者給藥。我們也已在 lenbelintide(前稱 AZD6234;為我們的選擇性胺淀素受體致效劑)的三項第三期試驗中完成首批患者給藥。

  • These trials are enrolling patients with obesity or overweight, with and without type 2 diabetes, including those receiving other incretin-based therapies. We look forward to sharing the Phase II results for lenbelintide and AZD9550, our dual

    這些試驗正在招募肥胖或過重患者,包含有或沒有第二型糖尿病者,也包括正在接受其他以腸泌素為基礎治療者。我們期待在即將到來的醫學會議上分享 lenbelintide 與 AZD9550(我們的雙重

  • Trung Huynh - Analyst

    Trung Huynh - Analyst

  • GLP-1 glucagon receptor agonist, both as monotherapies and in combination, at an upcoming medical conference. Beyond pipeline progress, earlier this month, we officially opened our newest strategic R&D center in Kendall Square, Massachusetts. This investment strengthens our presence in Greater Boston and places our scientists at the heart of one of the world's leading life sciences ecosystems. With that, please proceed to the next slide, and I'll pass over to Marc to cover Rare Disease.

    GLP-1/胰高血糖素受體致效劑)之第二期結果,包含單藥與合併治療。除管線進展外,本月稍早我們在麻薩諸塞州 Kendall Square 正式啟用最新的策略性研發中心。此項投資強化我們在大波士頓地區的布局,並讓科學家置身於全球領先的生命科學生態系核心。接下來請看下一張投影片,我將交給 Marc 介紹罕見疾病業務。

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

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

  • Thank you, Sharon. Rare Disease total revenue grew by 11% in the first nine months to $7.5 billion, underpinned by double-digit growth across all key medicines. This is driven by increased patient demand and continued global expansion following launches. In the third quarter, ULTOMIRIS revenues were up 19%, driven by growth across indications, including continued momentum in neurology.

    謝謝你,Sharon。罕見疾病總營收在前九個月成長 11% 至 75 億美元,主要受所有關鍵藥品皆呈現雙位數成長所支撐。這主要由患者需求增加,以及上市後持續的全球擴張所帶動。第三季 ULTOMIRIS 營收成長 19%,由各適應症的成長所驅動,其中包括神經領域的持續動能。

  • SOLIRIS revenues continue to decline due to the successful conversion to ULTOMIRIS, as well as biosimilar pressure. STRENSIQ grew 34% year-on-year, reflecting strong patient demand, continued global launches, and improved access. KOSELUGO continues to deliver strong global momentum, supported by expansion in adult patients with NF1-PN and the uptake of the granule formulation in recently launched markets. I wanted to highlight the multiple launch opportunities across Rare Disease.

    SOLIRIS 營收持續下滑,原因包括成功轉換至 ULTOMIRIS,以及生物相似藥的競爭壓力。STRENSIQ 年增 34%,反映強勁的患者需求、持續的全球上市,以及可近性改善。KOSELUGO 持續展現強勁的全球動能,受惠於在 NF1-PN 成人患者的擴展,以及在近期上市市場中顆粒劑型的採用。我想特別強調罕見疾病領域的多項上市機會。

  • ULTOMIRIS in IgAN recently received accelerated approval in the United States, with filings underway in Japan. Klygefa, formerly gefurulimab, is now approved in Japan for generalized myasthenia gravis, has positive CHMP opinion in Europe, and filed in other major markets. Amlypave, formerly anselamimab, has also been approved in Japan. Finally, our second-generation enzyme replacement therapy, efzimfotase alfa, has been filed across major markets and received priority review in the US, with a PDUFA date expected in the first half of '27.

    ULTOMIRIS 用於 IgAN 近期在美國獲得加速核准,日本也正在進行送件。Klygefa(前稱 gefurulimab)現已在日本獲准用於全身型重症肌無力,在歐洲獲得 CHMP 正面意見,並已在其他主要市場送件。Amlypave(前稱 anselamimab)亦已在日本獲准。最後,我們的第二代酵素替代療法 efzimfotase alfa 已在主要市場完成送件,並在美國獲得優先審查,預期 PDUFA 日期將落在 2027 年上半年。

  • Please advance to the next slide, where I will talk more to some of these opportunities and others in the pipeline. First, for patients with IgA nephropathy, our Phase III data for ULTOMIRIS demonstrated rapid, complete, and sustained terminal complement inhibition, with benefit consistent across patients. Our focus is on patients with higher risk of progression and inflammatory disease, which we estimate is approximately 20% of IgAN patients. IgAN is important in the continued expansion of our C5 Franchise, building on ULTOMIRIS' established leadership across multiple complement-mediated diseases.

    請切換到下一張投影片,我將進一步說明其中部分機會以及管線中的其他項目。首先,針對 IgA 腎病變患者,我們的 ULTOMIRIS 第三期數據顯示可快速、完全且持續地抑制末端補體,且各類患者的獲益一致。我們的重點鎖定在進展風險較高且具發炎性疾病特徵的患者,我們估計約占 IgAN 患者的 20%。IgAN 對我們持續擴大 C5 產品系列至關重要,並在 ULTOMIRIS 已於多種補體介導疾病中建立的領導地位之上,進一步拓展。

  • We are confident this indication would reach blockbuster potential, given our established nephrology presence across AstraZeneca and Alexion. Separately, we have also announced the discontinuation of ULTOMIRIS development in delayed graft function following a lack of consistent efficacy. Moving to efzimfotase alfa, as highlighted at the ASBMR, we believe the totality of evidence from the Phase III program supports the potential to expand the treatment opportunity in HPP. With less frequent, lower-volume dosing, improved tolerability, and evidence across a broader range of disease manifestation, we see the potential to reduce treatment burden and support better treatment continuity.

    鑑於我們在 AstraZeneca 與 Alexion 於腎臟科領域既有的布局與影響力,我們有信心此適應症可達到重磅藥(blockbuster)潛力。另外,我們也已宣布在移植延遲移植物功能(delayed graft function)方面,由於療效缺乏一致性,將停止 ULTOMIRIS 的開發。接著談 efzimfotase alfa,如同在 ASBMR 所強調的,我們認為第三期(Phase III)計畫的整體證據支持其在 HPP 中擴大治療機會的潛力。憑藉較低頻率、較小給藥量的劑量設計、更佳的耐受性,以及涵蓋更廣泛疾病表現的證據,我們看見其有望降低治療負擔並支持更好的治療持續性。

  • Combined with enhanced manufacturing capabilities and continued global expansion, we believe these attributes can support broader patient reach versus STRENSIQ. We believe efzimfotase alfa has the potential to become the preferred treatment option for patients with HPP. We expect growth to be driven by both the transition of patients currently receiving STRENSIQ and the expansion of the treated HPP population. This underpins our peak year sales expectation of $3 billion-$5 billion for efzimfotase alfa.

    結合製造能力的提升與持續的全球擴張,我們相信這些特性可支持相較於 STRENSIQ 更廣泛的病患觸及。我們認為 efzimfotase alfa 有潛力成為 HPP 病患的首選治療選項。我們預期成長將同時來自目前接受 STRENSIQ 治療病患的轉換,以及接受治療之 HPP 人口的擴大。這也支撐我們對 efzimfotase alfa 的高峰年度銷售額預期為 30 億至 50 億美元。

  • Cliramitug represents a significant opportunity to address the residual disease burden in ATTR cardiomyopathy. Despite currently available therapies, ATTR-CM remains progressive for many patients, with ongoing clinical events and functional decline. Cliramitug's differentiated depleter mechanism is designed to remove existing amyloid deposits, with our Phase I-B data showing positive cardiac remodeling. Importantly, around 90% of patients in that study were already receiving tafamidis, providing early evidence of activity on top of standard of care.

    Cliramitug 代表一項重要機會,可用以解決 ATTR 心肌病(ATTR cardiomyopathy)中仍殘存的疾病負擔。儘管目前已有可用療法,對許多病患而言,ATTR-CM 仍持續進展,臨床事件仍在發生且功能持續下降。Cliramitug 具差異化的清除(depleter)作用機制,旨在移除既有的類澱粉沉積;我們的第一期 B(Phase I-B)數據顯示正向的心臟重塑。重要的是,該研究中約 90% 的病患已在使用 tafamidis,提供了在標準治療基礎上仍具活性之早期證據。

  • The Phase III DepleTTR-CM trial builds on this, evaluating cliramitug on top of background therapy with hard clinical outcomes across all-cause mortality and cardiovascular events. If successful, we see the potential for cliramitug to alter the course of disease and become an important complementary treatment in ATTR-CM, representing a $3 billion to $5 billion non-risk-adjusted peak year revenue opportunity. Taken together, we see an exciting next Phase of growth for Alexion, combining continued expansion of our established franchises with multiple new launch opportunities and a pipeline with the potential to reach significantly more patients. With that, please advance to the next slide, and I will hand back to Pascal.

    第三期 DepleTTR-CM 試驗在此基礎上更進一步,於既有背景治療之上評估 cliramitug,並以全因死亡率與心血管事件等硬終點(hard clinical outcomes)作為評估指標。若試驗成功,我們認為 cliramitug 有潛力改變疾病進程,並成為 ATTR-CM 中重要的互補治療,對應一項未經風險調整(non-risk-adjusted)的高峰年度營收機會約 30 億至 50 億美元。綜合而言,我們看見 Alexion 令人振奮的下一階段成長:一方面持續擴張既有成熟產品線,另一方面擁有多項新上市機會與可觸及顯著更多病患的研發管線。接下來請翻到下一張投影片,我將把時間交回給 Pascal。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc. Next slide, please. Before we move to your questions, let me close with why we are so confident about the road ahead. Our pipeline continues to deliver, and the momentum builds further in 2027.

    謝謝你,Marc。請下一張投影片。在進入各位提問之前,讓我以我們為何對前方道路如此有信心作結。我們的研發管線持續交出成果,而動能將在 2027 年進一步增強。

  • It's going to be a very, very rich year. We expect more than 20 high-value trial readouts and pivotal data for nine potential new medicines. If you look at the whole list of readouts on this slide, of course, not everything is going to work, you have in non-risk-adjusted peak year revenue more than $20 billion. If you look at the right-hand side of this chart, it represents 40% of that peak year revenue.

    那將會是非常、非常豐收的一年。我們預期將有超過 20 項高價值試驗讀出(readouts),以及 9 款潛在新藥的關鍵性(pivotal)數據。如果你看這張投影片上所有讀出清單,當然不可能每一項都成功;但以未經風險調整的高峰年度營收來看,合計超過 200 億美元。若看圖表右側,則代表其中 40% 的高峰年度營收。

  • I'm drawing your attention to this because there is a whole series of small and mid-sized readouts that tend to fall below the radar, but it's important to look at those because the potential of our company and our pipeline should be assessed in aggregate. It takes time to go through all these products and all these indications, but that is the best way to get a good view of the potential growth we have, not only to 2030, but more importantly, through the next decade. A significant part of this more than $20 billion of peak year revenue should actually become reality over the next few years. Next slide, please.

    我特別提醒各位注意這點,因為有一整系列小型與中型的讀出往往不太受關注,但檢視它們很重要,因為對我們公司與研發管線潛力的評估應以整體(aggregate)來看。逐一檢視所有產品與所有適應症需要時間,但這是掌握我們成長潛力的最佳方式,不僅是到 2030 年,更重要的是延伸到下一個十年。這超過 200 億美元的高峰年度營收中,有相當一部分其實應會在未來幾年內成為現實。請下一張投影片。

  • This slide shows what I see as the foundation of our growth into and through the next decade, our new molecular entities with pivotal data readouts before 2030. We have 12 programs with peak year revenue potential of more than $5 billion. We have already launched three of these medicines, Datroway, Amlypave, and Baxfendy, and we've seen positive Phase III data for three more, efzimfotase alfa, tozorakimab, and Zegfrovy. In addition, we have four programs with peak year revenue potential of between $3 billion and $5 billion each, which will support our strengths beyond 2030.

    這張投影片呈現我所認為支撐我們進入並貫穿下一個十年成長的基礎:在 2030 年前將有關鍵性數據讀出的新分子實體(new molecular entities)。我們有 12 個計畫,其高峰年度營收潛力超過 50 億美元。其中我們已推出三款藥物 Datroway、Amlypave 與 Baxfendy,並且另外三項也已看到正向的第三期(Phase III)數據:efzimfotase alfa、tozorakimab 與 Zegfrovy。此外,我們還有四個計畫的高峰年度營收潛力各在 30 億至 50 億美元之間,將支撐我們在 2030 年之後的優勢。

  • Again, not everything is going to work, but it's important to look at the aggregate progress of the pipeline across so many products and indications. We expect our pipeline to more than offset the upcoming loss of exclusivities and to drive sustainable growth through the next decade.

    同樣地,不是每一項都會成功,但重要的是要看研發管線在如此多產品與適應症上的整體進展。我們預期研發管線將足以大幅抵消即將到來的專利/獨占期到期(loss of exclusivities)影響,並推動貫穿下一個十年的可持續成長。

  • Next slide, please. Let me bring this together. First, commercial momentum. Our medicines are in strong demand across therapy areas and geographies. That demand is driving growth across the company, and more importantly, it means more patients are benefiting from our medicines. We are firmly on track to deliver our 2030 ambition.

    請下一張投影片。讓我把重點整合一下。第一,商業動能。我們的藥物在各治療領域與各地區都維持強勁需求。這股需求正推動公司整體成長,更重要的是,代表有更多病患正從我們的藥物中受益。我們正穩健朝著實現 2030 年目標前進。

  • Second, pipeline delivery. We have reported 12 positive Phase III program readouts this year, with a collective potential peak year revenue well in excess of $10 billion, and we've had approval for four new medicines. We have a very rich upcoming series of readouts in 2027, with a potential non-risk adjusted peak year revenue of more than $20 billion. Third, we're investing for the future.

    第二,研發管線交付成果。今年我們已公布 12 項第三期(Phase III)計畫的正向讀出,其合計高峰年度營收潛力遠超過 100 億美元,且我們已有四款新藥獲得核准。我們在 2027 年將迎來一系列非常豐富的讀出,其未經風險調整的高峰年度營收潛力超過 200 億美元。第三,我們正在為未來投資。

  • By focusing on transformative technologies and by partnering with companies like Summit, we're building the platform that will fuel growth into the next decade and beyond. That pipeline is already delivering, with pivotal data expected for nine new medicines next year. Thank you for your time, and with that, we are ready for your questions.

    透過聚焦於具變革性的技術,並與 Summit 等公司合作,我們正在打造能驅動下一個十年及更長遠成長的平台。該研發管線已在交付成果,預期明年將有 9 款新藥的關鍵性(pivotal)數據。感謝各位撥冗,接下來我們準備回答各位的問題。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • (Operator Instructions) Mattias Häggblom, Nordea.

    (接線員指示)Mattias Häggblom,Nordea。

  • Mattias Haggblom - Equity Analyst

    Mattias Haggblom - Equity Analyst

  • Yes, I can. Sorry for that. Yeah. Thanks so much. Mattias Häggblom, Nordea. Two questions, please. Firstly, with regards to the slide 24 and the more than $20 billion non-risk adjusted peak year revenue potential, and 60% of that value derived from the six key events to the left on that slide, is it fair to distribute the peak revenue broadly average across the six key readouts, or is it rather so that perhaps some of Ansar carry an unproportional component of those $12 billion peak year revenue? Secondly, regarding the comment on the ESMO call earlier this week that AstraZeneca would have appetite for personalized cancer vaccines, should we think of that as an area likely to include partnering, or may it be so, just like for ADCs, that AstraZeneca has built in-house know-how and capacity? Thanks so much.

    是的,我可以。抱歉剛才那樣。好的,非常感謝。Mattias Häggblom,Nordea。我有兩個問題。第一個問題,關於第 24 張投影片提到的超過 200 億美元未經風險調整的高峰年度營收潛力,其中 60% 的價值來自該投影片左側的六個關鍵事件;我們是否可以把高峰營收大致平均分配到這六個關鍵讀出上?還是說,可能其中某些(例如 Ansar)承載了那 120 億美元高峰年度營收中不成比例的一部分?第二個問題,關於本週稍早 ESMO 電話會議中提到 AstraZeneca 對個人化癌症疫苗有興趣;我們應該把這視為一個可能會包含合作夥伴關係(partnering)的領域,還是可能像 ADC 一樣,AstraZeneca 已在內部建立了相關的專業能力與產能?非常感謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you. Thank you very much for these two questions, Mathias. If I understand well, the first one, if your point was, is Datroway representing a disproportionate portion of the total sales? The answer is no. Datroway is an important product, but I am trying to go back to slide 24. Yes, to be sure I have got the right way. Datroway, as you can see it here, is represented as a $5 billion plus opportunity across a variety of indications, and AVANZAR, of course, is a very important one. But if you look at the rest, I mean, the laroprovstat is going to be big.

    謝謝。Mathias,非常感謝你提出這兩個問題。如果我理解正確,第一個問題是:Datroway 是否在總銷售中占了不成比例的比重?答案是否定的。Datroway 是一個重要產品,但我想回到第 24 頁投影片。是的,為了確保我掌握正確的脈絡。如你在此所見,Datroway 在多種適應症上代表著超過 50 億美元的機會,而 AVANZAR 當然是非常重要的一項。但如果你看其餘部分,我是說,laroprovstat 也會很大。

  • We have also the fixed dose combinations, Adkarmai, Salopipe. Datroway is going to play an important role, but it is not the one that is going to be a make or break. We have a risk-adjusted approach in our forecast, and when we say that we can grow through 2030 and beyond, as I have said before, our risk adjustment across the totality of the portfolio, about 60%. So it is not very ambitious.

    我們也有固定劑量複方,Adkarmai、Salopipe。Datroway 將扮演重要角色,但它不是那種成敗關鍵的唯一因素。我們在預測中採用風險調整的方法;當我們說能夠成長到 2030 年及以後時,如我先前所說,我們對整體產品組合的風險調整約為 60%。所以這並不算非常激進。

  • We have done much better than that in the past. That is what also gives me confidence. Then the other thing I said, just to repeat, is on the right-hand side of this slide 24, 40% of the $20 billion are in these indications on the right-hand side. Again, you see Datroway there again in TROPION-Lung07, TROPION-Lung15.

    我們過去的表現其實比這更好。這也是讓我有信心的原因。另外我再重申一次:在第 24 頁投影片右側,200 億美元中的 40% 來自右側這些適應症。同樣地,你又會在 TROPION-Lung07、TROPION-Lung15 看到 Datroway。

  • But there are many more indications. So, I guess that answers your question, and to say Datroway is an important product, but it is not the only one. The second question is cancer vaccines, we are, for now, looking at doing it internally. We have got an Infectious Disease group that has worked over the last few years, the last couple of years in particular, on a variety of technologies that we believe can give us a way forward, but in this cancer vaccine space.

    但還有更多其他適應症。所以我想這回答了你的問題:Datroway 是重要產品,但不是唯一的產品。第二個問題是癌症疫苗;目前我們傾向先在內部推進。我們有一個傳染病團隊,過去幾年、尤其是最近一兩年,在多種技術上投入,我們相信這些技術能為我們在癌症疫苗領域提供前進的路徑。

  • But, I will leave it at that for today, and you will hear more about it in the next few months or years. The next question is from Simon Baker from Rothschild. Over to you, Simon.

    不過今天我先說到這裡;接下來幾個月或幾年你們會聽到更多相關內容。下一個問題來自 Rothschild 的 Simon Baker。交給你了,Simon。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Thank you, Pascal, for taking the question. Two quick ones, if I may, please. Firstly, one probably for Aradhana. I wonder if you could give us a little bit more color on the Reshaping for Sustainable Growth strategy.

    謝謝你,Pascal,讓我提問。如果可以的話,我有兩個簡短問題。第一個可能是問 Aradhana。想請你就「Reshaping for Sustainable Growth(重塑以實現永續成長)」策略提供更多細節。

  • I would assume that this is a transfer of OPEX from SG&A to R&D, but any color you can give us there would be great. Also, is the $2 billion a cash cost, or is it a mix of cash and non-cash? Then a question for Susan on puxitatug samrotecan. The B7-H4 space is fairly crowded. I wonder if you could call out the points of differentiation that you would like to highlight on puxitatug samrotecan versus some of the other competitor molecules in the space. Thanks so much.

    我猜這可能是把營運費用(OPEX)從 SG&A 轉移到 R&D,但若你能補充一些說明會很有幫助。另外,這 20 億美元是現金成本,還是現金與非現金的混合?接著有一個問題想問 Susan,關於 puxitatug samrotecan。B7-H4 領域相當擁擠。想請你點出 puxitatug samrotecan 相較於該領域其他競品分子,你最想強調的差異化重點是什麼。非常感謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Aradhana, you want to start?

    Aradhana,你要先開始嗎?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Sure. Thank you, Simon. I'll give you a few examples in terms of what this program actually involves. First of all, it's not targeted to one therapy area or one unit or one specific geography. It's really looking at, across our units, where all we have opportunity to align our investments and employees, et cetera, to make sure we're creating room for future opportunities and future growth. So, a good example would be, for example, clinical trial footprint. We run global clinical trials. As you know, where the opportunities are for clinical trials, what sites, new sites are emerging in places like the Middle East, et cetera, reimbursements changing in different geographies.

    好的。謝謝你,Simon。我用幾個例子說明這個計畫實際包含哪些內容。首先,它不是針對單一治療領域、單一事業單位或單一特定地理區域。它真正要做的是:在我們各個單位之間,找出所有可以讓投資與員工配置等更一致的機會,以確保我們能為未來機會與未來成長騰出空間。一個很好的例子是臨床試驗佈局。我們執行全球臨床試驗。如你所知,臨床試驗的機會在哪裡、哪些試驗中心、哪些新中心正在興起(例如中東等地),以及不同地區的給付/補償正在改變。

  • So, we want to align our clinical trial footprint to where the future is. Similar, for example, cell therapy, which is an area we're investing in, and that requires different skills and different investments. We're making technology investments in improving our process development. So, those are the types of things that, again, there's not one major thing.

    因此,我們希望把臨床試驗佈局調整到更符合未來趨勢的地方。同樣地,例如細胞治療也是我們投資的領域,這需要不同的技能與不同的投資。我們也在技術上投資,以改善我們的製程開發。所以這些就是相關的例子;再次強調,並不是只有一件大事。

  • There's many different smaller initiatives. The $2 billion is more of a cash cost. The benefits are, again, it's a three-and-a-half-year program, so it's not a one-time thing. The cost will come over this longer-term period, as will the benefits.

    而是許多不同的小型倡議。這 20 億美元比較偏向現金成本。效益方面,同樣地,這是一個為期三年半的計畫,所以不是一次性的。成本會在較長期間內逐步發生,效益也會在同一期間逐步顯現。

  • And the intention is, again, as I mentioned, to create room to continue to invest in new products and where the future growth will be. Susan?

    而其目的,如我提到的,是為了騰出空間,讓我們能持續投資於新產品,以及未來成長所在的領域。Susan?

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

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

  • Yeah, sure. So, thanks for the question about puxitatug samrotecan. Just as a reminder, B7-H4 is a transmembrane protein that's expressed highly in a number of solid tumors, including endometrial, breast, and ovarian cancer. With puxitatug samrotecan, we have the first B7-H4 ADC to enter Phase III registrational intent study, which is the BLUESTAR-Endometrial01.

    好的,當然。謝謝你關於 puxitatug samrotecan 的問題。提醒一下,B7-H4 是一種跨膜蛋白,在多種實體腫瘤中高度表現,包括子宮內膜癌、乳癌與卵巢癌。就 puxitatug samrotecan 而言,我們是第一個進入具註冊意圖之第三期(Phase III)研究的 B7-H4 ADC,也就是 BLUESTAR-Endometrial01。

  • We have FDA breakthrough therapy designation, which was granted based on the results that we've already seen, and granted in the first half of this year. And we've seen efficacy, particularly in the prior IO patients, with a 60% response rate and really good durability of response, which represents the BLUESTAR-Endometrial01 patient population. And recognize that, coming off ESMO, there were a number of other ADCs also targeting endometrial cancer, but B7-H4 expression in endometrial is broader than, for example, folate receptor alpha. We are confident about the linker payload that we have got with puxitatug samrotecan.

    我們已獲得 FDA 突破性療法認定(breakthrough therapy designation),這是基於我們已經看到的結果,並於今年上半年核准。我們也看到療效,特別是在既往接受過 IO(免疫腫瘤)治療的患者中,反應率達 60%,且反應持久性非常好;這正是 BLUESTAR-Endometrial01 的患者族群。另外也請注意,在 ESMO 之後,有多個其他 ADC 也在鎖定子宮內膜癌,但子宮內膜癌中的 B7-H4 表現範圍比例如葉酸受體 α(folate receptor alpha)更廣。我們對 puxitatug samrotecan 所採用的連接子/載荷(linker payload)很有信心。

  • We have got something that has very stable linker performance, and that leads to a lower rate of bone marrow toxicity than some of the other drugs that you see out there. That is going to be really important in the combinations, which is what we are building behind. You will see the opportunity for multiple combinations coming through with different mechanisms of action that will help build the potential for added value for puxitatug samrotecan. Thanks for the question.

    我們的產品具有非常穩定的連接子表現,這使得骨髓毒性發生率低於你在市面上看到的一些其他藥物。這在聯合治療中將非常重要,而這正是我們正在建立的方向。你將會看到多種不同作用機轉的聯合治療機會陸續出現,這將有助於提升 puxitatug samrotecan 的附加價值潛力。謝謝你的提問。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Great. Thank you, both. The next question is from Sachin Jain at Bank of America. Over to you, Sachin.

    很好。謝謝你們兩位。下一個問題來自美國銀行(Bank of America)的 Sachin Jain。交給你了,Sachin。

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • Thanks for taking my questions, two please, one short-term and then one mid-term. The short-term question, I guess, for Aradhana. R&D growth year-to-date sort of 5%, which is also what consensus assumes for 2027. A lot of what we have heard today is a lot of new Phase III starts.

    謝謝讓我提問;我有兩個問題,一個偏短期、一個偏中期。短期問題我想是問 Aradhana。年初至今(year-to-date)的研發(R&D)成長大約 5%,而市場共識對 2027 年的假設也差不多是這個水準。我們今天聽到的很多內容是啟動了許多新的第三期(Phase III)試驗。

  • Very simply thinking, do we think about R&D growth accelerating next year and how that impacts the extent of margin expansion, which currently stands at about 100 basis points in consensus? The second one is to touch on Pascal's sort of mid-term post-2030 commitment to growth. When do you think you will be in a position or willing to quantify that? I guess my question is, can you achieve that growth post-2030 based on what you already know today?

    很簡單地想,我們是否認為明年研發(R&D)成長會加速,以及這會如何影響利潤率擴張的幅度——目前市場共識約為100個基點?第二個是談談Pascal在2030年後中期對成長的某種承諾。你認為何時你們會處於可以、或願意將其量化的狀態?我想我的問題是:基於你們今天已知的情況,2030年後能否達成那樣的成長?

  • If the 2027 pipeline pays out as you hope for, what kind of growth could you envisage? Thank you very much.

    如果2027年的產品線(pipeline)如你們所希望地兌現,你們可以想像的成長幅度會是什麼樣子?非常感謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • That's an interesting question, Sachin. Thank you so much. The first one, I think, Aradhana, maybe you want to answer. Just a clarification, what you've heard from us today is a lot of readouts in 2027.

    這是個有趣的問題,Sachin。非常感謝。第一個問題,我想Aradhana,也許你想回答。先澄清一下,你今天從我們這裡聽到的是,2027年會有很多讀出(readouts)。

  • We will also start new Phase III, but we have a lot of Phase III readouts that carry a lot of potential peak year revenue. Over to you, Aradhana.

    我們也會啟動新的第三期(Phase III)試驗,但我們有許多第三期讀出,具備很大的峰值年度營收潛力。交給你了,Aradhana。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Sure. Sachin, I think your question was R&D specific, and R&D always sort of ebbs and flows, because in one year there will be studies starting, and there will be readouts and so forth. But maybe if I can take this opportunity, and I'm sure others have this on their mind, sort of how we look at the year ahead. First of all, we still have one quarter remaining in this year, so still need to get through that.

    好的。Sachin,我認為你的問題是針對研發(R&D),而研發一向會有起伏,因為某一年會啟動研究,接著會有讀出等等。但也許我可以藉此機會——我相信其他人也在想——談談我們如何看待接下來的一年。首先,今年還剩下一個季度,所以我們仍需要先把這一季走完。

  • Also, as all of you know, this is the time in the year when we go through our planning process, et cetera, so we're right in the middle of that, so we can't really give guidance. As you know, we'll give that in early next year. But if I look forward to next year, there is the continued momentum that you've seen in the results today in all the growth brands. There were a number of LCMs that were Data was presented on that at ESMO.

    另外,如各位所知,這是一年中我們進行規劃流程等工作的時點,我們正處於其中,因此無法真正提供指引(guidance)。如你們所知,我們會在明年年初提供。但如果我展望明年,今天你們在所有成長品牌的業績中看到的動能將會延續。有多項生命週期管理(LCM)相關資料已在ESMO上發表。

  • So, that momentum I expect to continue into next year. We also have a bunch of new launches. We're really looking forward to Tozo launching, Baxfendy's in the market, Etcamah across many markets, Dato, and all of those will require continued investment because they're early in their launch cycle. There are also some headwinds. Again, nothing surprising, things that you all are already aware of. Generic competition in some markets and Farxiga, SYMBICORT, Ruud covered, Calquence goes into IRA in 2027. Again, all the things that you're all very well aware of. We'll continue to invest in R&D, and focus remains on executing and building the pipeline, and we will share our guidance when we get to February of next year.

    因此,我預期這股動能會延續到明年。我們也有一批新上市產品。我們非常期待Tozo上市、Baxfendy已在市場上、Etcamah在多個市場推進、Dato等;而這些都需要持續投資,因為它們仍處於上市初期週期。也存在一些逆風。同樣地,沒有什麼令人意外,都是各位已經知道的事情。部分市場的學名藥競爭,以及Farxiga、SYMBICORT、Ruud covered,Calquence在2027年納入IRA。同樣,都是各位非常熟悉的事項。我們將持續投資研發(R&D),重點仍是執行與建構產品線(pipeline),並會在明年2月時分享我們的指引。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Aradhana. Sachin, your second question. The answer is really we haven't decided whether and when, if we did it, we would actually give a new number. Something we've sort of discussed, but we haven't really landed, and I think it's a little bit too early, to be honest.

    謝謝你,Aradhana。Sachin,你的第二個問題。答案是:我們尚未決定是否以及何時——如果要做——會給出一個新的數字。我們有討論過,但尚未真正定案;老實說,我認為現在還有點太早。

  • I'll explain why in a second. The reason why we are confident of growing past 2030 is the strength of the pipeline we have in our hands. In our long-range plan, what we do is we forecast each of these product and indications, at least those that we have a Phase III plan for, and then we risk adjust. Of course, we include expected price pressures, including MFN, and we risk adjust all these projects.

    我稍後解釋原因。我們有信心在2030年後仍能成長,原因在於我們手上產品線(pipeline)的強度。在我們的長期計畫中,我們會對每個產品與適應症進行預測——至少是那些我們已有第三期(Phase III)計畫的——然後進行風險調整。當然,我們也納入預期的價格壓力,包括MFN,並對所有這些專案進行風險調整。

  • When we risk adjust this forecast, we use, as I said, roughly I mean, each project has a different probability of success, of course, but the sort of average across the pipeline is about 60%. You can see it's not incredibly optimistic. It's relatively conservative. Of course, we can be very unlucky and deliver less than 60%, but we could also deliver more than 60%, which is what we have done in the last few years.

    在進行風險調整時,我如先前所說,大致上——當然每個專案的成功機率不同——但整體產品線的平均成功機率約為60%。你可以看到,這並不是非常樂觀的假設。相對保守。當然,我們也可能非常不走運,交付低於60%;但也可能交付高於60%,而這正是我們過去幾年所做到的。

  • But based on this average probability and the forecast we have, we see ourselves grow through for the post-2030 period. Now, in terms of communicating more around this and quantifying it, I think we need a little bit more time and probably go through next year and the readouts, get more data on some of these critical technologies we're progressing, like AZD0120 and cell therapy, the TCE, and others. Then maybe at some point, we might be able to give a new sort of a target that we give ourselves. But no commitment here, and certainly from a timing viewpoint, I could not tell you when we would be able to do that if we were to do it.

    但基於這個平均機率與我們的預測,我們看到自己在2030年後期間仍能持續成長。至於要如何對外溝通更多並加以量化,我認為我們需要多一點時間,可能要先走過明年以及相關讀出,取得更多關於一些我們正在推進的關鍵技術的資料,例如AZD0120與細胞治療、TCE以及其他項目。之後在某個時間點,我們或許能給出一個新的、我們為自己設定的目標。但這裡沒有承諾;而且就時點而言,如果我們要做,我也無法告訴你何時能做到。

  • Thank you. Steve Scala at Cowen. Over to you, Steve.

    謝謝。Cowen的Steve Scala。交給你了,Steve。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Thank you so much. Two questions. First, regarding Imfinzi subQ, competitors have been quite successful in shifting business to the subQ formulations. Does AstraZeneca now see similar opportunity? And if so, is there time to execute the switch before the LOE of Imfinzi IV? The second question is on China. China recently laid out several ambitious goals for its domestic biopharma industry through 2030. Should they deliver on those goals, would that be a headwind, tailwind, or a neutral for AstraZeneca? Thank you.

    非常感謝。兩個問題。第一,關於Imfinzi皮下(subQ),競爭對手在將業務轉向皮下劑型方面相當成功。阿斯特捷利康現在是否也看到類似的機會?如果是,在Imfinzi靜脈注射(IV)專利到期(LOE)之前,是否還來得及完成這個轉換?第二個問題是關於中國。中國最近為其本土生物製藥產業提出了到2030年的幾項雄心勃勃的目標。如果他們達成這些目標,對阿斯特捷利康而言會是逆風、順風,還是中性?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • That's great. Dave, maybe you want to take the first one, and Iskra, you could take the second one, the China one.

    很好。Dave,也許你來回答第一個;Iskra,你可以回答第二個,也就是中國的問題。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thanks, Steve, for the question. We are progressing Imfinzi subcutaneous with good pace, and we do expect to launch a subcutaneous version prior to coming on, or prior to LOE for Imfinzi. As we move into more and more earlier settings, which you're seeing with the continued progress that we make, we think that that's going to be particularly valuable to have that subcutaneous version as an offering for HCPs and their patients.

    謝謝你,Steve,提出這個問題。我們正以良好速度推進Imfinzi皮下(subcutaneous)版本,並且我們確實預期會在Imfinzi專利到期(LOE)之前推出皮下版本。隨著我們進入越來越多的早期治療情境——你也看到我們持續取得進展——我們認為能提供皮下版本,對醫療專業人員(HCPs)及其病患而言將特別有價值。

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

    Iskra Reic - Executive Vice President - Vaccines and Immune Therapies

  • Thanks for the question on China. Let me frame it in two different parts. First, as you saw in our results, we have another strong quarter in China, and we see the strong underlying growth of our business in China. If you exclude for the impact of the VBP for Forxiga, Roxadustat, and Lynparza this year, the growth is at the level of the strong 15%.

    謝謝關於中國的問題。我用兩個不同面向來說明。首先,如你在我們的業績中所見,我們在中國又有一個強勁的季度,我們也看到我們在中國業務強勁的基本面成長。如果排除今年Forxiga、Roxadustat與Lynparza的集採(VBP)影響,成長率約在強勁的15%水準。

  • That definitely shows the strength of our current portfolio. Equally, we had a number of the positive regulatory news, and we expect new inclusions in NRDL next year, specifically for the few eligible drugs, new drugs like Datroway or Tezspire. So we do believe that we have both portfolio and pipeline coming in China that will continue to fuel our growth in China. When it comes to the overall policies, we see many of the positives there, specifically when it comes to the better IP protection and strong regulatory data protection for the innovation, and overall, new 15th Five-Year Plan that recognize healthcare and innovation as a pillar industry and puts a lot of emphasis on the importance of the innovation in the biomedicines in China.

    這確實展現了我們目前產品組合的實力。同樣地,我們也看到多項正面的監管消息,並且預期明年會有新的藥品納入NRDL,特別是幾款符合資格的藥物,以及像Datroway或Tezspire這類新藥。因此,我們確實相信,我們在中國同時擁有產品組合與研發管線,將持續推動我們在中國的成長。就整體政策而言,我們看到許多正面因素,特別是在更佳的智慧財產權(IP)保護,以及對創新所需的強而有力的監管數據保護方面;此外,新的「十五五」規劃也將醫療健康與創新視為支柱產業,並高度強調中國生物醫藥創新的重要性。

  • Of course, that also comes with a strong competitive pressure, and as you know, we see more and more local Chinese companies that are strong competitors in some parts of our portfolio, specifically in Oncology. I would argue that in our forecast and plans, we have both. I would be hopeful that the overall impact will be neutral and will actually prove that our plans and optimism for the China forecast is in the right space.

    當然,這也伴隨著強烈的競爭壓力;如你所知,我們看到越來越多中國本土公司在我們產品組合的某些部分成為強勁競爭者,特別是在腫瘤領域。我會說,在我們的預測與規劃中,我們兩者都已納入考量。我希望整體影響將是中性的,並且最終會證明我們對中國市場預測的規劃與樂觀是站在正確的位置上。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Iskra. From a global viewpoint, still, I would say it's both a tailwind and a headwind, of course, because these companies are very competitive. I think it's overall more of a tailwind than a headwind for the companies that will be able to collaborate with Chinese companies, but also learn to compete with them. That's why we believe our position in China helps us do both of those, both collaborate and compete, learn to compete with them in term of the speed at which they move, et cetera.

    謝謝你,Iskra。從全球角度來看,我仍然會說這同時是順風與逆風,當然,因為這些公司競爭力非常強。我認為,對於能夠與中國公司合作、同時也學會與其競爭的公司而言,整體上更像是順風而非逆風。這也是為什麼我們相信我們在中國的布局能幫助我們同時做到這兩點:既能合作,也能競爭,並在他們推進速度等方面學會如何與其競爭,等等。

  • We've learned a lot, and we have adjusted the way we operate, not only in China, but also globally, based on what we learned watching how they operate. I think overall, certainly both tailwind, headwind for industry, and certainly hope that for us, it's more tailwind because of our position in China and the way we are able to leverage our strengths there for China, but also globally in term of collaborations. Next question is Richard Vosser at JPMorgan. Over to you, Richard.

    我們學到了很多,也根據觀察他們如何運作所得到的經驗,調整了我們的營運方式,不僅在中國,也在全球範圍內。我認為整體而言,這對產業來說確實同時是順風與逆風;也希望對我們而言,因為我們在中國的布局,以及我們能夠在中國、同時也在全球合作層面善用我們的優勢,更多會是順風。下一題是來自摩根大通(JPMorgan)的Richard Vosser。Richard,交給你。

  • Richard Vosser - Analyst

    Richard Vosser - Analyst

  • Thanks. Sorry, excuse me. Thanks, Pascal. Maybe a question on Tagrisso development from here, please. Obviously, strong performance in the quarter, but just how we should think about the performance going forward, potential from the uplift from SAFFRON and SANOVO that was called out today in ESMO, and actually thinking further beyond that, just what could the combinations with Datroway, TL15 bring to that franchise as well?

    謝謝。抱歉,不好意思。謝謝你,Pascal。想請教一下接下來Tagrisso的開發方向。本季表現顯著強勁,但我們應該如何看待未來的表現?今天在ESMO提到的SAFFRON與SANOVO帶來的上行潛力,可能會有多大?再往後延伸來看,與Datroway、TL15的聯合方案又可能為這個產品線帶來什麼?

  • Then a second question, just on the read from Lynparza to saruparib. So we saw you today maybe not to proceed forward in first-line ovarian with Lynparza, given the regulator issues between BRCA mutated and the HRD-positive setting. So, just what are your thoughts on saruparib as we think about the readout next year in both the HRRm patients and the non-HRRm patients? Just thoughts on saruparib next year. Thanks.

    第二個問題是關於從Lynparza到saruparib的解讀。我們今天看到你們可能不會在卵巢癌一線治療中繼續推進Lynparza,原因是監管機關在BRCA突變與HRD陽性適應症設定之間的問題。因此,想請問你們如何看待明年saruparib在HRRm患者與非HRRm患者兩個族群的讀出結果?也就是對明年saruparib的看法。謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

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

    第一個問題也許Dave你可以回答,然後第二個問題由Susan回答。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Absolutely. Thanks for the question. Tagrisso, with 8% sequential growth, I think is performing very well, and that strength is really coming on the back of a lot of good work that we are doing to establish FLAURA2 as the preferred regimen in frontline for patients with EGFR mutated disease. Now, what is really important on this, and gets to your point, what we saw, and I think is so key from SAFFRON, is in addition to opening up an opportunity for combinations in the second line for the 34% of patients who have MET-driven disease, we also now have the ability to be able to demonstrate and promote to starting with Tagrisso and staying with Tagrisso.

    當然可以。謝謝你的提問。Tagrisso季比成長8%,我認為表現非常好;這股動能主要來自我們為了將FLAURA2建立為EGFR突變疾病患者一線首選治療方案所做的大量扎實工作。而在這點上真正重要、也呼應你提問的是:我們從SAFFRON看到、且我認為非常關鍵的是,除了為34%具有MET驅動疾病的患者在二線治療開啟聯合用藥機會之外,我們現在也能夠證明並推廣「從Tagrisso開始,並持續使用Tagrisso」的治療策略。

  • This is something that really paves the way for what you asked about, TROPION-Lung15. We also have an opportunity with TROPION-Lung14 to be able to establish the Datroway combination in the frontline. As you begin to imagine kind of how the mindset becomes, we start with either FLAURA, FLAURA2, or TROPION-Lung14 in a frontline setting. There is an opportunity to then move to a Tagrisso-containing regimen post-progression on one of those, whether it is with SAFFRON or whether it is with TROPION-Lung15.

    這也確實為你所問的TROPION-Lung15鋪路。同時,我們也有機會透過TROPION-Lung14,在一線治療中建立Datroway的聯合方案。當你開始想像整體治療思維如何形成時,我們會在一線治療情境下,從FLAURA、FLAURA2或TROPION-Lung14其中之一開始。之後,在其中一種方案疾病進展後,仍有機會轉換到含Tagrisso的治療方案,不論是透過SAFFRON,或是透過TROPION-Lung15。

  • All of this creates an opportunity for the Tagrisso franchise to continue growing in a meaningful way, well on its way towards the LOE time that it has. I would also like to note that the acquisition of Zegfrovy gives us an opportunity to expand not just within the EGFR portion, that is the exon 19, but also with the exon 20 insertions, and we think that this gives us an even stronger position within this important space.

    這一切都為Tagrisso產品線在其專利到期(LOE)之前,持續以具實質意義的方式成長創造了機會。我也想補充,收購Zegfrovy讓我們有機會不僅在EGFR的exon 19領域擴展,也能涵蓋exon 20插入突變;我們認為這使我們在這個重要領域的布局更加穩固。

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

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

  • Okay. Thanks, Richard, for the question about saruparib. Just as a reminder, saruparib is a highly selective PARP1 only inhibitor, as opposed to Lynparza, which inhibits both PARP1 and PARP2. What that means is that you can get a much harder hit on PARP1 than you can achieve with Lynparza, and that is translated into an improvement in the efficacy that we have seen.

    好的。Richard,謝謝你關於saruparib的問題。提醒一下,saruparib是一種高度選擇性的僅PARP1抑制劑;相較之下,Lynparza同時抑制PARP1與PARP2。這代表你可以對PARP1產生比Lynparza所能達到更強的抑制效果,而這也轉化為我們所觀察到的療效提升。

  • We published some data at the ASCO GU Conference earlier this year in February. For example, in the castrate-sensitive patient population, we are seeing really good activity. We published data in the BRarna study as well in the castrate-resistant setting, where in both HRR and non-HRR, we see a PSA response rate in the 70% range for both groups of patients. If you just look at actual RECIST-based responses, we had 100% response rate in the HRR patient population and an 85% response rate in the non-HRR.

    我們在今年2月較早時於ASCO GU年會發表了一些數據。例如,在去勢敏感(castrate-sensitive)患者族群中,我們看到非常好的活性。我們也在BRarna研究中於去勢抗性(castrate-resistant)情境發表了數據;在HRR與非HRR兩個族群中,我們都看到PSA反應率約在70%的區間。如果只看以RECIST為基礎的實際反應,我們在HRR患者族群的反應率為100%,在非HRR族群為85%。

  • We do see activity, as we did with olaparib, in both the HRR and non-HRR. Just as a reminder of the EvoPAR-Prostate01 study, this is now in an earlier line setting than PROPEL, so it is in the metastatic castrate-sensitive patient population, a setting where 50% of patients progress within five years and 40% die within five years. This is still a high unmet need. What we have done is we have taken the learnings from the PROPEL study.

    我們確實看到活性,就像使用olaparib時一樣,在HRR與非HRR兩個族群皆然。再提醒一下EvoPAR-Prostate01研究:這項研究目前處於比PROPEL更早的治療線別,因此是在轉移性去勢敏感患者族群中進行;在這個情境下,50%的患者會在五年內進展,40%會在五年內死亡。這仍然是高度未被滿足的醫療需求。我們所做的是把從PROPEL研究得到的經驗納入。

  • Although we only received a BRCA mutant label in the US for PROPEL, we have got a broad label in Europe, and it was successful in the overall patient population. We did get a good hazard ratio for rPFS, including in the non-HRR population. Given the improved efficacy that we see with saruparib, including those data that I quoted from BRarna, and the design of the study, where we are taking in a powered element for both the HRR and non-HRR, as well as BRCA, which is one of the learnings that we took from the PROPEL study, I think we have got a good opportunity in this setting to really improve the standard of care in the castrate-sensitive patient population.

    雖然在美國,PROPEL我們只獲得BRCA突變的適應症標籤,但在歐洲我們取得了更廣泛的標籤,而且在整體患者族群中是成功的。我們也獲得了良好的rPFS風險比(hazard ratio),包括在非HRR族群中。考量到我們在saruparib上看到的療效提升(包括我引用的BRarna數據),以及研究設計中同時對HRR與非HRR、以及BRCA都納入具統計檢定力(powered)的要素——這也是我們從PROPEL研究汲取的經驗之一——我認為我們在這個治療情境中有很好的機會,能在去勢敏感患者族群中真正改善現行的照護標準。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Graham Parry, Citi.

    Graham Parry,花旗。

  • Graham Parry - Analyst

    Graham Parry - Analyst

  • Thanks for taking the questions. Pascal, on slide 7, you flagged the 12 positive Phase III readouts year to date. I think the market's arguably focused more on two failures, Wainua and SERENA-4. On your internal estimates, if you were actually looking at the risk-adjusted NPV of those readouts that you were expecting as you went through the course of the year, is your projection now that internally you think the value of those has gone up rather than down on aggregate through the course of the year?

    感謝讓我提問。Pascal,在第7張投影片上,你提到今年迄今有12項第三期(Phase III)試驗讀出為正面。我認為市場可能更聚焦在兩項失敗:Wainua 和 SERENA-4。就你們內部估算而言,如果你們在年內推進過程中,是以風險調整後的 NPV 來看待這些原本預期會讀出的結果,那麼你們現在內部的判斷是:整體而言,這些讀出的價值在年內是上升而非下降嗎?

  • Just sort of talking to your point on thinking about the aggregate numbers. Secondly, on Etcamah, pricing there looks in line with the approved oral SERDs. Obviously, both SERENA-6 and second line have a shorter PFS and smaller patient populations than in earlier lines. In the event that you were to see a positive readout on CAMBRIA-1 next year, is that level of pricing something you think would be sustainable for the large adjuvant population with treatment for five years plus? Thank you.

    我只是延伸你剛才關於整體數字的觀點。第二點,關於 Etcamah,目前的定價看起來與已獲核准的口服 SERD 相當一致。顯然,SERENA-6 與二線治療相較於更早期治療線別,PFS 較短且病患族群較小。如果你們明年在 CAMBRIA-1 看到正面讀出,對於需要治療五年以上、且規模龐大的輔助治療(adjuvant)族群,你們認為這樣的定價水準能否維持?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Graham. Maybe we start with the second question, Susan, so we have the time to load the slides so everybody can actually see it. Susan, do you want to call on

    謝謝你,Graham。也許我們先從第二個問題開始,Susan,這樣我們有時間把投影片載入,讓大家都能看到。Susan,你要請

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

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

  • For the pricing of Etcamah? Dave. Dave should cover it.

    關於 Etcamah 的定價嗎?Dave。這部分應該由 Dave 來說明。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Why don't I start first on the EpCAMR pricing question? Within that, I mean, first and foremost, what I'd like to just point out and use the opportunity, I think that the SERENA-6 enthusiasm is high across the globe. We've got over 30 markets with approvals. We are seeing good enthusiasm from clinicians.

    我先從 EpCAMR 的定價問題開始。首先我想指出並藉此機會說明的是,我認為全球對 SERENA-6 的熱度很高。我們已在超過30個市場取得核准。我們看到臨床醫師的接受度與熱情都很不錯。

  • Just off the back of ESMO, we had an opportunity to meet with a number of clinicians across the globe who are already incorporating ESR1 mutation testing into their regular practice. There's work that we're going to have to do on education, of course, but the demand increase that we're seeing in interest in ordering new lab results for ESR1 is certainly going in the right way. That's really great. I would also say that we're seeing, on pricing in general, some really encouraging movement in terms of setting a good value for medicine price in countries like the Middle East, but also most importantly within Japan.

    就在 ESMO 之後,我們有機會與全球多位臨床醫師會面,他們已經把 ESR1 突變檢測納入日常臨床實務。當然我們仍需要做一些教育工作,但我們看到對於開立 ESR1 新檢驗結果的興趣與需求正在上升,方向是正確的。這非常好。另外我也想說,就整體定價而言,我們看到一些相當令人鼓舞的進展,例如在中東等國家,以及更重要的是在日本,在為藥品定價、體現其價值方面都有正向的動能。

  • I think that that sets a good benchmark against which to think about that value for innovation and what we're seeing. We will approach early breast cancer when we see those results from CAMBRIA-1, and obviously also within that context, in some regards, we'll see other agents establish the early breast cancer price with some of the upcoming approvals that are going to be coming in. We'll advise on that when we get to that point then.

    我認為這為我們思考創新價值及其定價提供了一個很好的基準。當我們看到 CAMBRIA-1 的結果時,我們會再來處理早期乳癌(early breast cancer)的策略;同時在那個脈絡下,某種程度上,隨著接下來一些即將到來的核准,其他藥物也會逐步建立早期乳癌的價格水準。等到那個時點我們會再提供建議。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Dave. We've got a slide that everybody can look at to answer Graham's question. There's no doubt, actually, Graham, that if we look at it in net NPV, if you want, we've gone up net-net of the two failed studies, Wainua and also SERENA-4. Let me tell you why.

    謝謝你,Dave。我們有一張投影片讓大家可以看,用來回答 Graham 的問題。Graham,毫無疑問地,如果以淨 NPV 來看(如果你願意這麼表述),在扣除兩項失敗研究 Wainua 與 SERENA-4 之後,我們的淨值其實是上升的。我來說明原因。

  • First of all, it's important to remember Wainua is a shared product, so we didn't own 100% of the profitability coming out of it. The second is, of course, SERENA-4 was a large opportunity. Some of that opportunity is replaced by SERENA-6. The last point I will make, and if you look at many of these products, tozorakimab, I can tell you now because product's positive, but our probability of success, I think, was 20% or 25% in our risk-adjusted forecast.

    首先要記得,Wainua 是一個共同產品,因此我們並非擁有其100%的獲利。第二,SERENA-4 當然是一個很大的機會。其中一部分機會已由 SERENA-6 所取代。最後我想補充的是,如果你看這些產品中的許多,例如 tozorakimab,我現在可以告訴你,因為產品結果是正面的,但在我們的風險調整預測中,其成功機率我想只有20%或25%。

  • Now it's, of course, 100%. It's a big product. If you look at efzimfotase, it's also a large product. Many of the others are blockbuster opportunities, like IgAN is, and a number of others, DeLLphi-305 is a big one.

    現在當然是100%。這是一個很大的產品。如果你看 efzimfotase,它也是一個大型產品。其他很多也都有成為重磅藥(blockbuster)的機會,例如 IgAN,以及其他一些項目,DeLLphi-305 就是一個很大的項目。

  • Clarity, of course, we've just shown you a number. If you look at all of this, and I have to be careful because they're not yet approved, of course, not all of those. I mean, many of those are in the approval process, but there's a good chance they get approved. The data for each of those is very strong.

    Clarity 當然我們剛剛也向各位展示了一些數字。綜合來看,我必須小心措辭,因為它們當然還沒有全部獲批。我的意思是,其中很多正處於核准流程中,但它們獲批的機率很高。每一項的數據都非常強勁。

  • If you assume they are approved, definitely the net NPV has gone up, versus our risk-adjusted earlier forecast, even removing basically Wainua and SERENA-4, but adding all those readouts you see here on the slide. Thank you. The next question is from Rajan Sharma at Goldman Sachs.

    如果你假設它們都獲得核准,那麼相較於我們先前的風險調整預測,即使基本上移除 Wainua 與 SERENA-4,但加入你在投影片上看到的所有讀出結果,淨 NPV 肯定是上升的。謝謝。下一個問題來自高盛的 Rajan Sharma。

  • Rajan Sharma - Equity Analyst

    Rajan Sharma - Equity Analyst

  • Hi. Thanks for taking my question. Just on some of the new or imminent launches that you talked about there, you obviously got Baxfendy and Etcamah this year, and tozorakimab potentially next year if it's approved. Could you just maybe talk about how meaningful they will be from a revenue perspective next year in terms of drivers of growth?

    嗨,謝謝讓我提問。關於你們提到的一些新上市或即將上市的產品,你們今年顯然有 Baxfendy 和 Etcamah,而如果獲批,tozorakimab 可能在明年上市。你們能否談談,從明年的營收角度來看,它們在成長驅動上會有多大的意義?

  • For those are all indications or areas where you have existing commercial infrastructure. So how should we just think about the contribution to margins from those products, both next year and beyond? Thank you.

    這些都屬於你們已有既有商業化基礎設施的適應症或領域。那麼我們應該如何看待這些產品對毛利率/利潤率的貢獻,無論是明年或更長期?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you. Thank you, Rajan. So maybe, Ruud, you can cover some of this. Just as a reminder, when we launch in the US, of course, you have to get access, but I'm sure Ruud is going to cover this in detail. So you have Baxfendy, you have maybe Tozo you want to talk about and other things.

    謝謝。謝謝你,Rajan。那也許 Ruud 你可以說明其中一部分。提醒一下,當我們在美國上市時,當然需要先取得給付准入(access),但我相信 Ruud 會詳細說明。所以你有 Baxfendy,也有可能的 Tozo 你想談談,還有其他事項。

  • Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

  • Yeah, absolutely. Let's give a little bit of flavor. We have just started the launch in the US at the first full quarter. The way I would describe it's quite an encouraging start.

    好的,當然。我先提供一些概況。我們剛在美國啟動上市,這是第一個完整季度。我會形容這是一個相當令人鼓舞的開局。

  • We have already been able to deliver 12,000 new patient starts. As expected, most of those patient starts are in the commercial book of business, because we don't have any coverage yet in Part D, that will take some time. It's not unusual. We have submitted our bids for Part D to all the plans, hopefully we will see the coverage in 2028 coming through.

    我們已經成功帶來12,000名新病患開始用藥。如預期,多數這些新起始用藥來自商業保險(commercial)業務,因為我們在 Part D 目前尚未有任何給付涵蓋,這需要一些時間。這並不罕見。我們已向所有計畫提交 Part D 的投標,希望能在2028年看到給付涵蓋逐步到位。

  • We have bridging programs in place, what is very, let's say, pleasing to see is that both primary care physicians as well as specialists have started to prescribe Baxfendy. Likewise, there's a very healthy split between patients for resistant hypertension as well as for uncontrolled hypertension. So early days, for sure. We are hoping to see more commercial access as we go on in the course of 2028, then full coverage, if possible, in 2027 for commercial and 2028 for Part D.

    我們已建立橋接計畫(bridging programs)。令人相當欣慰的是,無論是基層照護醫師(primary care physicians)或專科醫師,都已開始開立 Baxfendy。同樣地,在抗藥性高血壓(resistant hypertension)與控制不佳高血壓(uncontrolled hypertension)病患之間,也呈現非常健康的分布。當然目前仍是早期階段。我們希望在2028年進程中看到更多商業保險准入,並在可能的情況下,商業保險於2027年達到全面涵蓋,而 Part D 於2028年達到全面涵蓋。

  • Likewise, for Tozo, the situation there is slightly different, because likewise, we need to have Part D access as well for Tozo, because the COPD patients are highly skewed to Part D. We will launch two formulations. One, the prefilled syringe, that will give us access in Part B in the US, as well as the auto-injector, that will give us access in Part D. So it's a bit more of a mixed one.

    同樣地,對於 Tozo,那邊的情況略有不同,因為同樣地,我們也需要為 Tozo 取得 D 部分(Part D)的給付可近性,因為 COPD 病患高度偏向 D 部分。我們將推出兩種劑型。第一是預充式注射器,這將讓我們在美國取得 B 部分(Part B)的可近性;以及自動注射器,這將讓我們取得 D 部分的可近性。因此這會是一個較為混合的佈局。

  • Clearly, we are excited about the Tozo. Pascal already mentioned that. I think the data is very strong, there's a very clear unmet medical need. So we will put our best efforts behind that launch as well as we go. But let's first see whether the regulators are going to give us the approval in the first half of 2027.

    很明顯地,我們對 Tozo 感到非常振奮。Pascal 已經提到過。我認為數據非常強勁,而且存在非常明確的未被滿足醫療需求。因此,隨著我們推進,我們也會把最好的資源投入到這次上市。但首先,讓我們看看監管機關是否會在 2027 年上半年給予核准。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Ruud. Dave, want Sorry? On camizestrant or not? Wendy, did you want to comment on camizestrant? I thought Marc, the question was more

    謝謝你,Ruud。Dave,你想——抱歉?是關於 camizestrant 還是不是?Wendy,你想就 camizestrant 發表評論嗎?我以為 Marc,問題更像是

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • So I think maybe I'll take a step back and just add to this. I think that if we take a look at the growth drivers for next year, definitely camizestrant and SERENA-6 is something that globally we see, Rajan, as a blockbuster opportunity. And I think that becomes also something that has continued growth behind it with SERENA-4 not being part of something that would cannibalize SERENA-6. Remember, SERENA-6 is the only study in a frontline advanced population.

    所以我想也許我先退一步,補充一下。我認為,如果我們看看明年的成長驅動因素,camizestrant 與 SERENA-6 絕對是我們在全球範圍內看到的、Rajan,具備重磅藥(blockbuster)潛力的機會。而且我認為,這也會成為一個持續成長的動能,因為 SERENA-4 並不是會侵蝕(cannibalize)SERENA-6 的一部分。請記得,SERENA-6 是唯一在一線晚期族群中進行的研究。

  • And so, it's really an opportunity for us to differentiate there. I'd add to that Zegfrovy, DeLLphi-305, what we see with VOLGA together with the Imfinzi indications, back to what Pascal was speaking about earlier, each of those is blockbuster opportunities. So we've got several really exciting growth drivers from just the catalysts that have read out that give us opportunity for growth in the year ahead.

    因此,這確實是我們在那裡做出差異化的機會。我也要補充 Zegfrovy、DeLLphi-305,以及我們與 VOLGA 連同 Imfinzi 適應症所看到的情況,回到 Pascal 先前談到的,每一項都是重磅藥機會。所以,僅就已讀出結果的催化劑而言,我們有數個非常令人振奮的成長驅動因素,讓我們在接下來一年有成長機會。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Since we covered the whole pipeline, maybe we can also ask Marc, from an Alexion viewpoint, what are the major growth drivers for 2027?

    既然我們已經涵蓋了整個研發管線,也許我們也可以問 Marc,從 Alexion 的角度來看,2027 年的主要成長驅動因素是什麼?

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

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

  • Yeah. We have the launch of Klygefa as a third-generation C5 inhibitor. This will be in myasthenia gravis. I think this is going to be a new option for patient in the most dynamic part of the segment, with an auto-injector on a weekly sub-cut, with a low volume.

    是的。我們將推出 Klygefa,作為第三代 C5 抑制劑。這將用於重症肌無力。我認為這會在該細分市場最具動態的部分,為病患提供一個新選擇:每週一次皮下注射的自動注射器,且注射量低。

  • I think we are quite happy to have another option apart from our infusion injectable, SOLIRIS and ULTOMIRIS. You have heard that we have recently obtained the approval for ULTOMIRIS in IgAN. This is obviously a very interesting field where many new mechanisms are getting approved these days. We have good data on proteinuria reduction, and we do believe that the complement inhibition plays an important role in many patients of IgAN.

    我認為,除了我們的輸注注射劑 SOLIRIS 與 ULTOMIRIS 之外,能有另一個選擇我們非常高興。各位也聽到我們最近已取得 ULTOMIRIS 在 IgAN 的核准。這顯然是一個非常有趣的領域,因為近來有許多新機轉陸續獲批。我們在蛋白尿降低方面有良好數據,並且確實相信補體抑制在許多 IgAN 病患中扮演重要角色。

  • I mentioned in my prepared remark, we have other products being prepared for launch, but we are also very excited by the progress we are making in the development. We do not know the results, obviously, for cliramitug, and we believe

    我在事先準備的發言中提到,我們還有其他產品正在為上市做準備,但我們也對研發進展感到非常振奮。我們當然還不知道 cliramitug 的結果,但我們相信

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • 2027 growth.

    2027 年成長。

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

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

  • 27 growth. This will not be for 27 years. Thank you, Pascal.

    27 年成長。這不是指 27 年。謝謝你,Pascal。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • So maybe just to add, I think your second question was around, how does it fit in terms of the cost and the launch cost, et cetera? I will not go into every product, but a few big picture themes to think about. First of all, we start investing in front of every launch, right? Depending on what that launch is, we may start somewhere between 18 to 24 months, in terms of whether it is market shaping activity, non-branded promotion, payer market research.

    所以也許再補充一下,我想你的第二個問題是關於:在成本與上市成本等方面,它如何契合?我不會逐一談每個產品,但提供幾個可思考的宏觀主題。首先,我們會在每一次上市之前就開始投資,對吧?視上市性質而定,我們可能會在上市前約 18 到 24 個月開始,例如市場塑造活動、非品牌推廣、支付方市場研究。

  • So there is a whole bunch of activities that are going on before an actual launch. When we actually launch, when a product breaks even on an annual basis depends on a number of different things. It may depend on, in the biopharma space, that can take, for example, on average, four-plus years. First couple of years is really getting the access at the right place, and that is when your investment after that, in year three, four, starts breaking even.

    因此,在實際上市之前會有一整套活動在進行。當我們真正上市後,產品在年度基礎上何時達到損益兩平,取決於多種不同因素。例如在生物製藥領域,平均可能需要四年以上。前幾年主要是在正確的位置取得可近性(access),而在那之後,你在第三、第四年的投資才開始達到損益兩平。

  • In Oncology and rare diseases, it may be sooner, in a couple of years, but that is sort of the type of investment. There are obviously places where we have existing sales forces. For example, in Datroway, we are already in the breast cancer space. For Truqap, we are already in that space, but it does require building that even further.

    在腫瘤與罕見疾病領域,可能會更快,約兩年左右,但大致就是這類型的投資節奏。當然,有些地區我們已有既有的銷售團隊。例如 Datroway,我們已在乳癌領域。Truqap 也是,我們已在該領域,但仍需要進一步擴建。

  • Then there are also new areas we are entering in, so eosinophilic esophagitis, we do not have a presence in that space, so that is where we need to build. Again, it is very dependent on those dynamics. We obviously try to leverage where we have the capabilities, but it does require investment, and it does require a few years before it breaks even.

    另外也有我們正在進入的新領域,例如嗜酸性食道炎,我們在那個領域沒有既有佈局,因此需要建立能力。同樣地,這非常取決於那些動態因素。我們顯然會盡量運用既有能力,但仍需要投資,而且通常需要幾年時間才會達到損益兩平。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thibault Boutherin, Morgan Stanley. Over to you,

    Thibault Boutherin,摩根士丹利。交給你,

  • Thibault Boutherin - Equity Analyst

    Thibault Boutherin - Equity Analyst

  • Yes, thank you very much. Just a couple of pipeline questions. The first one is on the CAMBRIA-1 opportunity. As I understand it's in the setting for patients who already completed a cycle of adjuvant therapy on the CDK4/6 plus AI combo, or AI alone for the patient not eligible to CDK4/6.

    是的,非常感謝。我有幾個關於研發管線的問題。第一個是關於 CAMBRIA-1 的機會。據我理解,這是在已完成一個輔助治療療程的病患情境:使用 CDK4/6 加 AI 的組合,或是對不適用 CDK4/6 的病患使用單獨 AI。

  • Just see if you could give us an idea of what's the biggest pool of patient, if it's coming from CDK4/6 combo plus AI, or if it's the AI mono in terms of funnel coming into CAMBRIA-1 opportunity. The reason I ask for this is because obviously a competitor is trying to address the AI mono, so how does that impact the funnel of patients going into CAMBRIA-1? I'll just stop there. Thank you.

    想請你們談談,進入 CAMBRIA-1 機會的病患最大來源池,究竟是來自 CDK4/6 組合加 AI,還是來自 AI 單藥(mono),就漏斗(funnel)而言。我之所以這樣問,是因為顯然有競品正試圖切入 AI 單藥,因此這會如何影響進入 CAMBRIA-1 的病患漏斗?我先問到這裡。謝謝。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • I'm going to start just first with making sure that we're clear on the design, and then we can go from there.

    我先從確保我們對試驗設計的理解一致開始,然後再往下談。

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

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

  • Yeah. Thanks for the question. CAMBRIA-1 is looking at camizestrant in the extended adjuvant setting in patients with intermediate to high-risk hormone receptor-positive and HER2-negative breast cancer. It's a switch design, and it takes patients who've had already 2 to 5 years of adjuvant endocrine therapy with or without CDK4/6 inhibitor, who obviously then need to remain free of invasive disease, and are planning 5 further years of adjuvant endocrine therapy.

    好的。謝謝你的問題。CAMBRIA-1 是在延伸輔助治療(extended adjuvant)情境中評估 camizestrant,對象為中度至高風險的荷爾蒙受體陽性且 HER2 陰性的乳癌病患。這是一個切換(switch)設計,納入已接受 2 到 5 年輔助內分泌治療、可合併或不合併 CDK4/6 抑制劑的病患;這些病患顯然需要維持無侵襲性疾病,並且計畫再接受 5 年的輔助內分泌治療。

  • Then it randomizes them one-to-one to continuing their current standard endocrine therapy and AI or tamoxifen, and versus camizestrant 75 milligrams. So that's the design of the study with the primary endpoint of invasive breast cancer-free survival. Then perhaps, Dave, do you want to talk about the size of the opportunity?

    接著以一比一隨機分派:一組持續目前的標準內分泌治療(AI 或 tamoxifen),另一組則改用 camizestrant 75 毫克。因此,這就是該研究的設計,主要終點為侵襲性乳癌無病存活(invasive breast cancer-free survival)。然後也許,Dave,你想談談機會的規模嗎?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Yeah, absolutely. I think the important point to note on this is that CAMBRIA-1 allows for us, first and foremost, to address the prevalent pool of patients. This is why it's such an important part of the strategy. CAMBRIA-2 is for the incident population pool, but I think that if we take a look then at CAMBRIA-1, it allows, if the study's positive and if we get it approved, to be able to come in and make an offer to patients, an option for patients they'll have today either being treated with an AI or an AI CDK4/6.

    是的,完全同意。我認為這裡需要注意的重要一點是,CAMBRIA-1 讓我們首先且最重要的是,能夠處理現有(prevalent)的患者族群。這也是為什麼它在策略中如此重要。CAMBRIA-2 針對的是新發(incident)患者族群,但我認為如果我們再看回 CAMBRIA-1,若研究結果為正向且我們獲得核准,它就能讓我們進入市場,向患者提出一個選項——對於今天的患者而言,他們目前的治療要嘛是使用 AI(芳香化酶抑制劑),要嘛是 AI + CDK4/6。

  • On your question about what patients we expect to flow into this, I think in many respects, this study anticipates and is protected against multiple futures. Because it includes prior adjuvant CDK4/6 patients, if we see that grow, those are patients that would be eligible in the study, or if monotherapy without the CDK4/6 is what we see prior, that as well is something that would be eligible within CAMBRIA-1.

    關於你問到我們預期哪些患者會納入這項研究,我認為在許多方面,這項研究預先考量並且能夠因應多種未來情境。因為它納入了既往接受過輔助治療(adjuvant)CDK4/6 的患者,如果我們看到這類用藥增加,這些患者就會符合研究資格;或者如果我們看到既往治療是未合併 CDK4/6 的單藥治療,那同樣也會符合 CAMBRIA-1 的納入條件。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Dave. The next question is from Trung Huynh at RBC. Over to you. Frank, can you hear me?

    謝謝你,Dave。下一個問題來自 RBC 的 Trung Huynh。交給你。Frank,你聽得到我嗎?

  • Trung Huynh - Analyst

    Trung Huynh - Analyst

  • Yeah, sorry. I was just taking mute off. Thanks for taking my questions. Just on your oral CVRM combinations, in the presentation, you highlighted the PCSK9 Crestor combination with Phase II data expected in the first half next year.

    聽得到,抱歉。我剛把靜音關掉。謝謝讓我提問。關於你們的口服 CVRM(心血管、腎臟與代謝)聯合療法,在簡報中你們強調了 PCSK9 與 Crestor(瑞舒伐他汀)的組合,並預期明年上半年會有第二期數據。

  • Then we noticed in the appendix a GLP-1 dapagliflozin combination as well. Just thinking about how you're thinking about the differentiation of these assets and their subsequent positioning. And we also didn't see a GLP-1 PCSK9 combination listed. Is that still under consideration? Thank you.

    另外我們也注意到附錄裡還有一個 GLP-1 與 dapagliflozin(達格列淨)的組合。想請教你們如何看待這些資產的差異化,以及後續的定位。我們也沒有看到列出 GLP-1 與 PCSK9 的組合。那個仍在考慮中嗎?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you. Sharon, do you want to cover this? And maybe, Awad, if you want to jump in on that.

    謝謝。Sharon,你要不要先回答這題?另外 Awad,如果你也想補充的話。

  • Sharon Barr - Executive Vice President - Bio Pharmaceuticals Research and Development

    Sharon Barr - Executive Vice President - Bio Pharmaceuticals Research and Development

  • Sure. I think you asked us three questions. The first was about the PCSK9 and the combinations. The second was about dapagliflozin combinations, and the third was about elecoglipron plus PCSK9.

    好的。我想你其實問了三個問題。第一個是關於 PCSK9 以及相關組合。第二個是關於 dapagliflozin 的組合。

  • I will try to break those down. Your first question was about laroprovstat. That is our oral PCSK9, which we think is a very differentiated molecule. You have noted that we are moving forward with multiple studies for that molecule in Phase III as monotherapy and also in combination.

    我會嘗試把它們拆開來回答。你的第一個問題是關於 laroprovstat。那是我們的口服 PCSK9,我們認為它是一個差異化非常明顯的分子。你也提到我們正推進這個分子在第三期的多項研究,包含單藥治療以及聯合治療。

  • The combination makes a lot of sense there. In our monotherapy studies, we are allowing patients to add this on top of background statins because we know that is standard of care, but that is a really important mechanistic interaction, and the mechanistic interaction is a theme for our fixed-dose combinations. What PCSK9 does is let the LDL receptors keep recycling, and that effect is additive to statins. it is a clear rationale to be able to combine those two things together, and therefore, it makes sense to build a fixed-dose combination with rosuvastatin. Your second question was about combining dapagliflozin and- GLP-1 our oral GLP-1, elecoglipron.

    在這裡做組合治療非常合理。在我們的單藥研究中,我們允許患者在既有的他汀類背景治療上加用本藥,因為我們知道那是標準治療;但這裡有一個非常重要的機轉交互作用,而這種機轉交互作用正是我們固定劑量複方(fixed-dose combinations)的主軸。PCSK9 的作用是讓 LDL 受體能持續回收再利用,而這個效果與他汀類是加成的。因此,把這兩者結合在一起有非常清楚的理據,所以用 rosuvastatin(瑞舒伐他汀)來建立固定劑量複方是合理的。你的第二個問題是關於把 dapagliflozin 與我們的口服 GLP-1——elecoglipron——做組合。

  • You can imagine why that makes sense. When we think about patients that were living with complex interrelated cardiovascular, renal, and metabolic disease, they are dealing with multiple disease drivers. By combining SGLT2, which is standard of care in diseases like heart failure, kidney failure, and type 2 diabetes, you are also dealing with patients who have interrelated disease that is driven by excess weight or obesity, which is effectively addressed by a GLP-1 receptor agonist. Only AstraZeneca has the portfolio that allows us to combine a small molecule GLP-1 receptor agonist together with an SGLT2 inhibitor. it is both logical for these patients to be able to address multiple disease drivers, and it is also a key feature in simplifying their patient care and making sure that they are not just maximizing the therapeutic window of each of these molecules, but deriving the at least additive benefit of these two put together.

    你可以想像為什麼這樣做很合理。當我們想到那些同時面臨複雜且彼此相關的心血管、腎臟與代謝疾病的患者時,他們往往同時受到多個疾病驅動因素影響。透過結合 SGLT2(在心衰竭、腎衰竭與第二型糖尿病等疾病中屬於標準治療),同時也能照顧到那些疾病彼此相關、且由過重或肥胖所驅動的患者;而這一點可由 GLP-1 受體致效劑有效處理。只有阿斯特捷利康(AstraZeneca)擁有能把小分子 GLP-1 受體致效劑與 SGLT2 抑制劑結合的產品組合。這不僅在邏輯上能讓這些患者同時處理多個疾病驅動因素,也是在簡化患者照護上的關鍵特色,確保他們不只是各自最大化每個分子的治療窗,而是能從兩者合併中獲得至少加成的效益。

  • Your third question was about why would we not combine our PCSK9 together with elecoglipron? We have signaled that we are interested in that potential combination as one of the many combinations that we can partner with our oral GLP-1. As you know, dyslipidemia is frequently a comorbidity of patients who are living with excess weight or obesity, and so that is a logical next step for us as we explore how we maximize the potential for elecoglipron. We have already demonstrated the positive Phase II data and moved into an expansive Phase III program for elecoglipron as a monotherapy, and we are exploring fixed-dose combination opportunities for that molecule, as you mentioned.

    你的第三個問題是:為什麼我們不把 PCSK9 與 elecoglipron 結合?我們已經表明,我們對這個潛在組合有興趣,這會是我們口服 GLP-1 可搭配的眾多組合之一。如你所知,血脂異常常見於過重或肥胖患者,作為共病相當普遍,因此在我們探索如何最大化 elecoglipron 潛力時,這是合乎邏輯的下一步。我們已經展示了 elecoglipron 正向的第二期數據,並推進到一個規模龐大的第三期單藥治療計畫;同時也如你所提到的,我們正在探索該分子的固定劑量複方機會。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Sharon. Awad, do you want to add anything?

    謝謝你,Sharon。Awad,你要補充什麼嗎?

  • Unidentified Company Representative

    Unidentified Company Representative

  • No. The only piece, Pascal, if I take it one step higher, is that our strategy is to address the comorbidities of the patients. Weight management, overweight is only one dimension of our strategy. I think, as Sharon said, we have a unique opportunity with our portfolio to combine and to address multiple morbidities at the same time. I think that is a unique feature of our strategy.

    沒有。唯一想補充的是,Pascal,如果我把層次拉高一點,我們的策略是處理患者的共病。體重管理、過重只是我們策略的一個面向。我認為如 Sharon 所說,我們憑藉產品組合有一個獨特的機會,能夠透過組合在同一時間處理多種疾病負擔。我認為這是我們策略的一個獨特特徵。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you. The next question is from James Gordon at Barclays. Over to you, James.

    謝謝。下一個問題來自 Barclays 的 James Gordon。交給你,James。

  • James Gordon - Analyst

    James Gordon - Analyst

  • Hello. James Gordon from Barclays. Thanks for taking the question. It is sort of two questions.

    你好。我是 Barclays 的 James Gordon。謝謝讓我提問。我大概有兩個問題。

  • One is, so new pipeline directions for AstraZeneca and the investment there. It sounds like quite a lot of exciting areas. So the in-house ADCs, IO bispecific, cell therapy, cancer vaccine, VEGF, obesity, lots of new areas. Which ones do you think would require the most incremental investment and the biggest growth potential when we are thinking about new ways to treat diseases?

    第一個是關於阿斯特捷利康(AstraZeneca)新的研發管線方向以及相關投資。聽起來有很多令人興奮的領域。例如內部開發的 ADC、IO(免疫腫瘤)雙特異性抗體、細胞治療、癌症疫苗、VEGF、肥胖等,很多新領域。當我們思考新的疾病治療方式時,你認為哪些領域需要最多的新增投資、且具有最大的成長潛力?

  • Connected to that, I know that there are new areas to invest in, but then there is also what sounds like quite a big cost reallocation program, and you have top-line growth. If we put it all together, is the message that the cost reallocation program and the top-line growth would be there to keep the margins above flat whilst you do all this investment? Can you do all this investment and also have margin expansion medium long term?

    第二個相關問題是:我知道有新的領域需要投資,但同時也有一個看起來規模不小的成本重新配置計畫,而且你們也有營收(top-line)成長。如果把這些放在一起看,是否可以理解為:成本重新配置計畫與營收成長,將用來在你們進行這些投資的同時,讓利潤率至少維持不低於持平?你們能否在進行這些投資的同時,也在中長期實現利潤率擴張?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Let me just start the first part, and Aradhana, you could take the second part, or maybe not. The first part, actually, James, is a good question, but some of these technologies are at different stages of development. If you look at cell therapy, we are more advanced, and we are spending more money in cell therapy right now, of course, because we are in full swing of our Phase III programs and for AZD0120, but also looking at other CAR-T and investing in in vivo cell therapy. So, different technologies here are at different stages of progress.

    我先回答第一部分,Aradhana,你可以回答第二部分,或者也不一定。第一部分其實是個好問題,James,但這些技術目前處於不同的開發階段。如果你看細胞治療,我們進展更快,而且我們現在在細胞治療上投入更多資金,當然是因為我們的第三期計畫正全面推進,包括 AZD0120,同時也在看其他 CAR-T,並投資於體內(in vivo)細胞治療。所以,不同技術在這裡的進展階段並不相同。

  • But we believe that we can actually balance the P&L. It is, of course, never easy when you have a pipeline of that magnitude. It is a great problem to have. We have many, many projects.

    但我們相信,我們其實可以在損益表(P&L)之間取得平衡。當你有如此規模的研發/產品管線時,當然從來都不容易。但這其實是個很好的煩惱。我們有非常、非常多的專案。

  • We will continue investing in those and, of course, try to defend and protect our operating margin. Beyond this, I do not know, Aradhana, that we want to be more specific about these operating margins. We have given you our objective in the past, and I cannot say that anything has changed.

    我們會持續投資於這些專案,當然也會努力捍衛並保護我們的營業利潤率。除此之外,Aradhana,我不確定我們是否想要就這些營業利潤率提供更具體的說法。我們過去已經給過你們我們的目標,我也不能說有任何改變。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Yeah, I'd just say, we look at what we've done over the last several years, right? We've continued to drive operating leverage, and at our investor day, we talked about this back in 2024, and we made a commitment to our 2026 margin. We did say at that time that going forward, it'll depend on a variety of scenarios. We're at a place now where our pipeline is very rich, and we'll remain disciplined, but we need to continue to invest in things as they unfold. We'll give our guidance for next year in February next year.

    是的,我只想說,我們回頭看過去幾年我們所做的事情,對吧?我們持續推動營運槓桿;在我們的投資人日上,我們在2024年就談過這點,並且對2026年的利潤率做出承諾。我們當時也說過,往後會取決於各種不同情境。我們現在所處的位置是,我們的管線非常充實;我們會保持紀律,但也需要隨著事情的發展持續投資。我們會在明年2月提供明年的財測指引。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Maybe also something that may be obvious, but it's maybe worth reminding everybody is that, you have a certain number of new projects, new technologies we're investing in, but there's also a number of products for which the life cycle and the investment plan is declining. If you look at Tagrisso, Imfinzi, or FASENRA, and some others, I guess, the investment is over the next couple of years, of course, going to start to decline as we invest in new products. So you got to really look at what is decreasing versus what is increasing, and that's how we manage it all. Of course, we constantly work on improving productivity, so that we can invest more in our pipeline.

    也許還有一點可能很明顯,但值得提醒大家:你們看到我們在投資一定數量的新專案、新技術,但同時也有一些產品,其生命週期與投資計畫正在下降。如果你看Tagrisso、Imfinzi或FASENRA,以及其他一些產品,我想在接下來幾年,隨著我們投資新產品,這些產品的投資當然會開始下降。所以你必須真正去看哪些在下降、哪些在上升,而這就是我們管理整體的方式。當然,我們也持續致力於提升生產力,讓我們能在管線上投入更多。

  • The next question is Peter Verdult at BNP. Peter?

    下一個問題是來自BNP的Peter Verdult。Peter?

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Hello, can you hear me?

    你好,你們聽得到我嗎?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Yeah, go ahead. Can you hear me? Yeah, sorry. Yeah, go ahead, Peter. We can hear you.

    可以,請說。你聽得到我嗎?對,不好意思。對,請說,Peter。我們聽得到你。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Good. Sorry. Peter Verdult, BNP Paribas. I wanted to continue a conversation we started at ESMO earlier this week.

    很好。不好意思。我是BNP Paribas的Peter Verdult。我想延續我們本週稍早在ESMO開始的一段對話。

  • Just when we think about Europe, how are the European leaders reacting to one, the wave of innovation coming from China that was in clear evidence at ESMO, and your comments today build on what we are hearing elsewhere. R&D spend, clinical trial recruitment, manufacturing investments increasingly moving away from the region. So, when you interact with the leaders, do you have any optimism that innovation going forward is going to be better rewarded in Europe? Then just a much more simple question for Ruud.

    當我們思考歐洲時,歐洲的領導者如何看待、以及如何回應:第一,在ESMO上非常明顯可見、來自中國的創新浪潮;而你們今天的評論也呼應了我們在其他地方聽到的情況。研發支出、臨床試驗招募、製造投資正愈來愈多地移出該地區。所以,當你們與這些領導者互動時,你們是否對未來創新在歐洲能獲得更好的回報抱持任何樂觀?接著是一個更簡單、給Ruud的問題。

  • I heard all your comments during the Q&A and prepared remarks about Baxfendy, but can you just remind us, how have you approached ex-US pricing in the U.K. and Mexico, where I think you have just recently launched, versus the US given MFN considerations? Thank you.

    我聽到你們在問答與準備講稿中對Baxfendy的所有評論,但你能否提醒我們:在英國與墨西哥(我想你們最近才剛上市)等美國以外市場,你們在定價上相對於美國是如何處理的,尤其考量MFN因素?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Well, thank you, Peter. Maybe let me just give a sort of overall view, and then Ruud could comment on Baxfendy, and maybe Dave, if you want to comment also on the Gamma, please feel free. But the overall view is that you have to look at not only Europe, but also Japan, because these are the countries that are in the reference basket of countries in MFN. I will say, again, historically, Europe and Japan were very big sources of innovation, and suddenly both of those have declined relative to the US and more recently China, of course.

    謝謝你,Peter。也許我先給一個整體觀點,然後再請Ruud談談Baxfendy;另外Dave,如果你也想就Gamma補充評論,也請隨時。整體來看,你不只要看歐洲,也要看日本,因為這些國家都在MFN的參考國家籃子裡。我再說一次,歷史上歐洲與日本曾是非常重要的創新來源,但突然之間,兩者相對於美國、以及近年來當然還有中國,都出現了下滑。

  • So, I will say in Japan, there is a clear recognition by the government that the ecosystem needs to become more attractive. I must say that there is some very positive feedback in term of pricing level and access and reimbursement of new products. I think Japan is really quite encouraging, I must say. In Europe, there are green shoots of progress in some countries.

    所以我會說,在日本,政府明確認知到這個生態系需要變得更具吸引力。我必須說,在新產品的定價水準、可近性與給付/報銷方面,有一些非常正面的回饋。我必須說,日本確實相當令人鼓舞。在歐洲,一些國家也出現了進展的萌芽。

  • It is still early days, so I think it is hard to be more definitive. I will say overall, my sense is, if you look at Japan and Europe, there are countries where we can be a little bit more hopeful than we were some time ago in term of adjusting, improving access, and improving pricing and reimbursement. As a reminder, by the way, MFN doesn't require Japan or Europe to reach US prices. It requires that it reaches GDP-adjusted US prices.

    但仍然是早期階段,所以我認為很難下更明確的結論。整體而言,我的感覺是,如果你看日本與歐洲,有些國家在調整、改善可近性、以及改善定價與給付/報銷方面,我們可以比一段時間以前更抱持一些希望。順帶提醒一下,MFN並不要求日本或歐洲達到美國的價格。它要求的是達到以GDP調整後的美國價格。

  • Again, the logic of a MFN program is over time that US prices would decline a little bit, and European prices would go up a little bit. That is really what we are trying to achieve with the various products. I must say I am a lot more optimistic, cautiously optimistic, they would say, today than I would have been a few months ago in term of our ability to improve the environment in Japan and some countries in Europe. Ruud?

    再說一次,MFN計畫的邏輯是,隨著時間推移,美國價格會小幅下降,而歐洲價格會小幅上升。這正是我們希望透過各項產品所要達成的目標。我必須說,就我們改善日本以及歐洲部分國家環境的能力而言,今天我比幾個月前更樂觀——他們會說是審慎樂觀。Ruud?

  • Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

  • Yeah, not a lot to add, Pascal, for obvious reasons. Of course, we try to bring our new medicines, our new innovation to as many as possible, the patients around the world, including in Europe. The MFN dimension is one, of course, we are now considering. Let us go through the process.

    是的,Pascal,基於顯而易見的原因,我沒有太多要補充的。當然,我們會努力把我們的新藥、我們的新創新帶給全球盡可能多的病患,包括歐洲的病患。MFN的面向當然是我們現在正在考量的一個因素。讓我們走完這個流程。

  • Let us get the regulatory approvals there. The positive element is that we have, beyond the United States, we have launched also now in the Middle East. The good news is that we are getting good prices for Baxfendy there as well. Hopefully that will also be a trigger moment for European governments to consider this important new medicine, helping patients with severe hypertension.

    讓我們先取得那邊的法規核准。正面的因素是,除了美國之外,我們現在也已在中東上市。好消息是,我們在那裡的Baxfendy也取得了不錯的價格。希望這也能成為一個觸發點,促使歐洲各國政府重新考量這個重要的新藥,來幫助重度高血壓患者。

  • Let us see how it is going to work out. The European teams are working day in, day out in order to get it in the hands of patients and physicians.

    我們就看看最後會如何發展。歐洲團隊日以繼夜地努力,為的是讓病患與醫師能夠取得這項藥物。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Ruud. In interest of time, we will move on because there is a couple of questions that are left. Seamus Fernandez at Guggenheim. Seamus, do you want to go?

    謝謝你,Ruud。為了時間起見,我們要往下進行,因為還剩下幾個問題。下一位是Guggenheim的Seamus Fernandez。Seamus,你要開始嗎?

  • Seamus Fernandez - Equity Analyst

    Seamus Fernandez - Equity Analyst

  • Yes. Thanks so much for the question. Aradhana, just hoping you could clarify and help us think about the impact that the restructuring program could have on margins going forward. Is this going to be fully recycled back into R&D?

    是的。非常感謝這個提問。Aradhana,我希望你能釐清並協助我們思考重整計畫未來可能對利潤率造成的影響。這是否會全部回收再投入到研發(R&D)?

  • Then as we just think about the margin structure, are you comfortable with where the street is for the next couple of years as it relates to operating margins? Then just as a quick question for you, Pascal. One of the things that AstraZeneca has been extraordinarily good at is coming from behind in the areas where there's high competition. Can you just maybe help us think about the areas where you think Astra is uniquely underappreciated, but where areas like Farxiga would provide a good example for us to think about as Astra as a come-from-behind player?

    另外,當我們思考利潤率結構時,就未來幾年營業利潤率而言,你是否認為市場共識(street)的預期水準是你們可以接受的?再快速問你一個問題,Pascal。AstraZeneca非常擅長在競爭激烈的領域後發先至。你能否幫我們思考一下:有哪些領域你認為市場對Astra獨特優勢的認知仍被低估?並且有哪些領域可以用像Farxiga這樣的例子,來讓我們理解Astra作為後發者的策略?

  • Thanks.

    謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • A great question. Maybe, Hana, do you want to go on the first one?

    這是個很好的問題。也許,Hana,你想先回答第一個嗎?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Yeah. The answer to, I think, your first question is yes, though we will look to reinvest. Again, it's also not just about reinvesting. It's also, like I said, creating the capacity to do more without expanding our cost base as much.

    是的。我想你第一個問題的答案是肯定的,不過我們會尋求再投資。再說一次,這也不只是關於再投資。也如我所說,這同時是在不讓我們的成本基礎擴張那麼多的情況下,創造做更多事情的能力。

  • Technology will play a role. Obviously, some of this reinvesting, recycling, reshaping, all of that will play a role. So that's the answer to your first question. Your second question, I won't go into, though I know everybody is very creative in asking the same question.

    科技將會扮演一個角色。顯然,其中一部分的再投資、資源回收再利用、重塑調整等等,都會發揮作用。所以這就是你第一個問題的答案。至於你的第二個問題,我就不展開了,雖然我知道大家都很有創意,會用不同方式問同一個問題。

  • We will not provide long-term margin guidance in spite of many ways and creativity in asking that question. Pascal will get into the third question.

    儘管大家用各種方式、很有創意地問這個問題,我們仍不會提供長期的利潤率指引。Pascal 會回答第三個問題。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Aradhana. First of all, I would say, Seamus, we are not always coming from behind. We sometimes are in the lead. We are in the lead in many places.

    謝謝你,Aradhana。首先我想說,Seamus,我們並不總是落後追趕。我們有時候是領先的。我們在很多地方都是領先者。

  • I would say that if you go back in history, Tagrisso is in the lead, PACIFIC indication is in the lead. More recently, Tozo is in the lead. So we are not always coming from behind, as you say. But if I take your question about coming from behind, I think there's maybe two examples I could give, but there are more- Yeah quite frankly, because at the end of the day, if you look at the consensus forecast that is public knowledge, everybody looks at it, sees us decline post-2031 or 2032, something like that.

    我會說,如果你回顧歷史,Tagrisso 是領先的,PACIFIC 適應症也是領先的。更近期,Tozo 也是領先的。所以我們並不總是像你說的那樣從後追趕。但如果我就你關於「從後追趕」的問題來看,我想也許可以舉兩個例子,當然還有更多——坦白說,因為歸根究柢,如果你看公開的市場一致預測,大家都會看,並看到我們在 2031 或 2032 年之後出現下滑,差不多是那樣。

  • It really shows that people do not necessarily appreciate the whole pipeline. Maybe two places. One is, I do not like this word, I think it is the wrong term, actually, weight management. The reason I think we can actually make it there is in part based on what Ruud and Sharon has explained before.

    這其實顯示人們未必充分理解整個研發管線。也許有兩個領域。第一個是——我不喜歡這個詞,我覺得其實用詞不當——體重管理。我之所以認為我們確實能在那裡建立一席之地,部分是基於 Ruud 和 Sharon 之前所解釋的內容。

  • We do not see this as simply a weight reduction approach. What we are trying to do is address the metabolic syndrome, the insulin resistance. There are a lot of people around the world, millions, hundreds of millions, who do not look obese. They may not even sometimes look overweight, but they have abdominal adiposity, the visceral fat.

    我們不把這僅僅視為一種減重方法。我們想要處理的是代謝症候群、胰島素阻抗。全球有很多人,數以百萬計、甚至數以億計,他們看起來並不肥胖。他們有時甚至看起來不算過重,但他們有腹部脂肪堆積,也就是內臟脂肪。

  • These people, they also often have complications like hypertension, cholesterol, pre-diabetes, diabetes, kidney disease, low-level inflammation in their body that leads to other complications. We are really aiming at addressing this complex multiform syndrome, if you want, by combining products that help people reduce the excess visceral fat they have, but also address their kidney disease or their pre-diabetes or their cholesterol. That is really what we are trying to do. I think if we do that well, I think we will do it well, because we have a really strong Phase III programs of indications that I think will differentiate us, of course, combinations, which I think will also differentiate us.

    這些人也常常伴隨高血壓、膽固醇問題、糖尿病前期、糖尿病、腎臟疾病,以及體內低度發炎,進而導致其他併發症。我們真正的目標,是透過產品組合來處理這種複雜、多型態的症候群:一方面幫助人們減少過多的內臟脂肪,同時也處理他們的腎臟疾病、糖尿病前期或膽固醇問題。這才是我們真正想做的事。我認為如果我們把這件事做好——我也相信我們會做得很好,因為我們有非常強的第三期臨床計畫與適應症布局——這些將使我們脫穎而出;當然,還有我認為同樣能讓我們差異化的各種組合療法。

  • If we do that well, then we actually can craft a very nice position in this market and also help patients around the world. The second example I might give is cell therapy, where we know that we are newcomers to the field, but we are making rapid progress, and AZD0120 is looking pretty good, quite honestly. I think cell therapy is the other place. Today with CAR T, tomorrow with in vivo, where, because in vivo, we are also moving as fast as we can, in vivo cell therapy, that is.

    如果我們把這件事做好,那麼我們確實能在這個市場打造一個非常好的定位,同時也能幫助全球的病患。我可能舉的第二個例子是細胞治療。我們知道我們是這個領域的新進者,但我們進展很快,而且老實說,AZD0120 看起來相當不錯。我認為細胞治療是另一個領域。今天是 CAR T,明天是體內(in vivo),而且因為 in vivo,我們也在盡可能加速推進——也就是 in vivo 細胞治療。

  • I think it is another place, but there are other examples, but also examples where we are in the lead. In interest of time, we will move to maybe the last question. Michael Leuchten. Michael, over to you.

    我認為這也是另一個領域;當然還有其他例子,也有一些例子是我們處於領先地位。為了時間起見,我們可能轉到最後一個問題。Michael Leuchten。Michael,交給你。

  • Michael Leuchten - Analyst

    Michael Leuchten - Analyst

  • Oh, thank you, Pascal, for squeezing me in. Just a very quick one on RSG. Just interested in the timing of triggering that program now. Was there a gating item that triggered it?

    喔,謝謝你,Pascal,讓我插進來提問。我只想很快問一個關於 RSG 的問題。我只是想了解現在啟動這個計畫的時點。是否有某個關鍵門檻項目觸發了它?

  • Why now? You have always been very busy with the pipeline. You could have triggered something like it earlier. Why now?

    為什麼是現在?你們一直都在研發管線上非常忙碌。你們其實可以更早啟動類似的事情。為什麼是現在?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • I think, again, there's no sort of ideal timing to pick for this. But when we looked across the company on the LOE of Farxiga, which happened in the US, some of the trial readouts that we've had and launching, looking at how we need to think about, we've had questions on pricing and launches, the clinical trial footprint, technology where about a year back, we had just started to embed and change many of our processes to enable AI being embedded. When I say process, it's not drug discovery research, but many of our other processes. It was just a confluence of factors that we decided to make this into a program and start now.

    我想再說一次,這件事其實沒有什麼所謂的「理想時點」。但當我們從公司整體來看 Farxiga 的專利到期(LOE)——這件事已在美國發生——以及我們取得的一些試驗讀出與產品上市進展,再加上我們需要如何思考:我們也收到關於定價與上市的問題、臨床試驗的足跡布局、以及科技面向;大約一年前,我們才剛開始把 AI 內嵌到許多流程中並推動流程變革。我所說的流程不是藥物發現研究,而是我們其他許多流程。這些因素匯聚在一起,讓我們決定把它做成一個正式計畫,並在現在啟動。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Yeah, absolutely. And we didn't decide this in the last two weeks, right? We've been working on this, planning for this since the beginning of the year. But when you announce this, you need to be sure you have a good plan and you can implement it.

    是的,完全同意。而且我們不是在過去兩週才做這個決定,對吧?我們從年初就一直在做這件事、規劃這件事。但當你要對外宣布時,你必須確定你有一個好的計畫,而且能夠落地執行。

  • It's not new. We've been working on this, and essentially because we believe we have to redeploy resources. We believe we have a pipeline we need to support, and then every dollar we can save, we reinvest in the pipeline, so we create future growth. And of course, today you have also AI that is helping in some areas to make us faster, smarter, and then we can, in some cases, grow without growing, is sort of the expression, which is you grow without adding as many people as you would have if you didn't have the use of AI.

    這不是新鮮事。我們一直在做這件事,基本上是因為我們相信必須重新部署資源。我們相信我們有一條需要支持的研發管線,而我們能省下的每一塊錢,都會再投資到研發管線中,從而創造未來成長。當然,今天也有 AI 在某些領域提供協助,讓我們更快、更聰明;因此在某些情況下,我們可以用一句話來形容:在不增加那麼多人力的情況下實現成長——也就是如果沒有使用 AI,你本來會需要增加更多人。

  • All these factors, as Aradhana said, have taken us to this place today, but we've been planning for this since the beginning of the year. With this, I'll maybe close the meeting. And again, thank you so much for your interest in the company, and I wish you all a good weekend.

    如 Aradhana 所說,所有這些因素把我們帶到今天這一步,但我們從年初就一直在規劃。那麼我可能就此結束會議。再次非常感謝各位對公司的關注,並祝大家週末愉快。