AstraZeneca PLC (AZN) 2024 Q3 法說會逐字稿

內容摘要

阿斯特捷利康在為投資者和分析師舉辦的網路研討會上展示了其強勁的收入成長和在腫瘤學領域的進步。儘管中國面臨挑戰,但他們強調了對關鍵市場創新和擴張的承諾。主要研發亮點包括 IO 雙特異性藥物和 ADC 計畫的進展,以及臨床試驗的正面數據。

該公司仍致力於推動未來幾年的成長和獲利,並專注於管道再生和未來的戰略雄心。他們討論了他們在全球市場的地位、監管批准的重要性以及腫瘤學和罕見疾病領域即將出現的催化劑。阿斯特捷利康表達了在臨床試驗中取得積極成果的信心,並強調了藥物開發策略中合規性和持續學習的重要性。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good morning to those joining from the US.

    來自美國的參加代表早安。

  • Good afternoon to those in the UK and Central Europe, and good evening to those listening in Asia.

    祝英國和中歐地區的聽眾下午好,祝亞洲地區的聽眾晚上好。

  • Welcome, ladies and gentlemen, to AstraZeneca's nine months and Q3 Results 2024 webinar for investors and analysts.

    女士們、先生們,歡迎參加阿斯特捷利康針對投資者和分析師的九個月和 2024 年第三季業績網路研討會。

  • Before I hand over to AstraZeneca, I'd like to read the safe harbor statement.

    在交給阿斯特捷利康之前,我想先讀安全港聲明。

  • The company intends to utilize the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995.

    該公司打算利用 1995 年美國私人證券訴訟改革法案的安全港條款。

  • Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca.

    本次電話會議的參與者可能會對阿斯特捷利康的營運和財務表現做出前瞻性陳述。

  • Although we believe our expectations are based on reasonable assumptions, by their very nature forward-looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

    儘管我們相信我們的預期是基於合理的假設,但前瞻性陳述本質上涉及風險和不確定性,並且可能受到導致實際結果與這些前瞻性陳述表達或暗示的結果有重大差異的因素的影響。

  • Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call.

    本次電話會議中所做的任何前瞻性陳述均反映本次電話會議時所掌握的知識和資訊。

  • The company undertakes no obligation to date forward-looking statements.

    該公司不承擔發布前瞻性陳述的義務。

  • Please also fully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation.

    請同時全面閱讀本簡報隨附的幻燈片中的前瞻性聲明免責聲明。

  • (Operator Instructions) And with that, I will now hand you over to the company.

    (操作員指示)現在我將您移交給公司。

  • Andy Barnett - Head of Investor Relations

    Andy Barnett - Head of Investor Relations

  • A warm welcome to AtraZeneca's year-to-date and third quarter 2024 presentation conference call and webcast for investors and analysts.

    熱烈歡迎阿斯特捷利康針對投資者和分析師舉行的今年迄今和 2024 年第三季演示電話會議和網路廣播。

  • I'm Andy Barnett, Head of Investor Relations.

    我是投資者關係主管安迪巴內特 (Andy Barnett)。

  • And before I hand over to Pascal and other members of the executive team, I would like to cover some important housekeeping points.

    在我將任務交給帕斯卡和其他執行團隊成員之前,我想先談談一些重要的常規事項。

  • Firstly, all of the materials presented today are available on our AstraZeneca's Investor Relations website.

    首先,今天提供的所有資料均可在我們的阿斯特捷利康投資者關係網站上找到。

  • Next slide, please.

    請看下一張投影片。

  • This slide contains our Safe Harbor statement, which I'll encourage you to take time to read.

    這張投影片包含我們的安全港聲明,我鼓勵您花時間閱讀。

  • We'll be making comments on our performance using constant exchange rates, or CER, core financial numbers and other non-GAAP measures.

    我們將使用固定匯率(CER)、核心財務數據和其他非 GAAP 指標對我們的業績做出評論。

  • A non-GAAP to GAAP reconciliation is contained within the results announcement.

    業績公告中包含非 GAAP 與 GAAP 的對帳表。

  • All numbers quoted are in millions of US dollars, unless otherwise stated.

    除非另有說明,所有引用的數字均以百萬美元為單位。

  • Next slide, please.

    請看下一張投影片。

  • This slide shows our agenda for today's call.

    這張投影片展示了我們今天電話會議的議程。

  • Following our prepared remarks, we'll open the line for questions.

    在我們發表完準備好的發言後,我們將開放提問專線。

  • As usual, we will try to address as many of the questions you have during the allocated time, although please limit the number of questions you ask to allow others a fair chance to participate in the Q&A.

    像往常一樣,我們將嘗試在分配的時間內解答您的盡可能多的問題,但請限制您提出的問題數量,以便其他人有公平的機會參與問答。

  • And with that, Pascal, I'll hand over to you.

    說完這些,帕斯卡,我就把麥克風交給你了。

  • Next slide, please.

    請看下一張投影片。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Andy, and welcome, everyone.

    謝謝你,安迪,歡迎大家。

  • In the third quarter, total revenue grew by 21% driven by strong underlying global demand for our medicines.

    第三季度,受全球對我們藥品強勁需求的推動,總收入成長了 21%。

  • Core EPS increased 27% to $2.08, reflecting our continued focus on profitability.

    核心每股收益成長 27% 至 2.08 美元,反映出我們對獲利能力的持續關注。

  • If you want to move to the next slide, please.

    如果您想移至下一張投影片,請。

  • In the year-to-date, total revenue grew 19% and core EPS grew 11%.

    今年迄今,總收入成長了 19%,核心每股收益成長了 11%。

  • As a reminder, total revenue and core EPS in the first nine months of 2023 benefited from one-time collaboration revenue and other core operating income totaling $1.1 billion, which makes the 2024 year-to-date growth rate even more impressive.

    需要提醒的是,2023 年前9 個月的總收入和核心每股收益受益於一次性合作收入和其他核心營運收入,總計11 億美元,這使得2024 年年初至今的成長率更加令人印象深刻。

  • Importantly, this performance is across all of our focused therapy areas with each delivering double-digit growth in both the third quarter and in the year to date.

    重要的是,這一表現涵蓋了我們所有重點治療領域,每個領域在第三季和今年迄今都實現了兩位數的成長。

  • Given the strength of our underlying business, I'm pleased to announce we have upgraded our full year guidance, and we now expect both total revenue and core EPS to increase by high teens percentages.

    鑑於我們基礎業務的實力,我很高興地宣布,我們已上調了全年業績預期,現在我們預計總收入和核心每股收益都將以高百分比增長。

  • Aradhana will provide you with additional detail.

    Aradhana 將為您提供更多詳細資訊。

  • Please move to the next slide.

    請移至下一張投影片。

  • Taking a closer look at our total revenue performance in the first nine months of the year, we continue to benefit from our broad global presence.

    仔細審視今年前九個月的總收入表現,我們持續受惠於廣泛的全球影響力。

  • Our company is growing across all regions and we continue to strengthen our capabilities in many markets around the world, most notably in the emerging markets outside of China, where for another quarter, our performance is standing out from our peers with 30% growth in the year-to-date.

    我們的公司在所有地區都在發展,我們繼續加強在全球許多市場的能力,最值得注意的是中國以外的新興市場,在另一個季度,我們的業績在同業中脫穎而出,成長率為 30%。今年迄今為止。

  • And you can see now the very good distribution of our revenue across the world, 43% in the US, 21% in Europe, 13% in China.

    現在您可以看到我們的收入在全球的分佈非常好,43%在美國,21%在歐洲,13%在中國。

  • It's very pleasing to see the emerging markets outside of China are now bigger than China with 14% of our revenue and 9% for the established rest of the world.

    我們非常高興地看到,中國以外的新興市場如今已經比中國更大,占我們收入的 14%,佔世界其他成熟市場的 9%。

  • So very strong distribution.

    分佈非常強。

  • But we want to see even more growth in the US over the next few years as part of our 2030 ambition.

    但作為 2030 年目標的一部分,我們希望未來幾年看到美國實現更大的成長。

  • And this is why we decided today here in New York to announce this $3.5 billion investment in the US in manufacturing and R&D.

    這就是我們今天在紐約決定宣布向美國製造業和研發部門投資 35 億美元的原因。

  • US is, of course, a very important market, and that supports innovation, and we will continue to invest to grow fast in this in this part of the world, but very, very good growth across the world in the emerging markets, in China, but also very much outside of China.

    美國當然是一個非常重要的市場,它支持創新,我們將繼續投資,促進該地區的快速增長,但全球新興市場,比如中國,也實現了非常非常好的增長。一部分地區。

  • With this chart, I'd like to take a moment to address recent developments in China, which of course have been the subject of a lot of speculation.

    透過這張圖表,我想花點時間來討論中國最近的發展,當然這些發展已經成為許多猜測的主題。

  • We are actually not privy to the details of any of this investigations.

    我們實際上並不清楚任何有關該調查的細節。

  • If requested we will cooperate fully as we have in the past.

    如果有請求,我們將像過去一樣全力配合。

  • As you can imagine, I personally take these matters very seriously, and the whole company also takes it, of course, very, very seriously.

    你可以想像,我個人對這些事情非常重視,當然整個公司也非常非常重視。

  • It's important to realize we don't have many details.

    我們必須認識到我們掌握的細節並不多。

  • We haven't been approached as a company.

    我們還沒有被當作一家公司來聯繫。

  • We will, of course, collaborate with the authorities you've requested to do this. but we have very limited information.

    當然,我們將與您要求的相關部門合作完成此事。但我們掌握的資訊非常有限。

  • And today, we would like to focus on Q3 to the extent possible unless they are questions relating to China that haven't been answered before by Aradhana last week when she organized the call.

    今天,我們希望盡可能地關注第三季度的問題,除非這些問題與中國有關,而這些問題在上週 Aradhana 組織電話會議時尚未得到回答。

  • Importantly, we remain committed to our presence in China, and we will continue to invest in the country to support the discovery and the delivery of our life-changing medicines.

    重要的是,我們仍然致力於在中國的發展,並將繼續在中國投資,以支持我們改變生命的藥物的發現和交付。

  • And finally, we're doing what we can to support our employees in China.

    最後,我們正在盡力支持我們在中國的員工。

  • They're all hard at work.

    他們都很努力工作。

  • They're all very focused and continuing to develop our pipeline, but also our portfolio of marketed products.

    他們都非常專注並持續開發我們的產品線以及我們的市場產品組合。

  • I just want to take a moment to thank all these employees for their continued dedication to our purpose.

    我只想花一點時間感謝所有員工對我們目標的持續奉獻。

  • We have 17,000 employees in China and all these employees are working very hard and making us all happy with how they have developed our presence in China over the last few years.

    我們在中國有 17,000 名員工,這些員工都非常努力地工作,他們在過去幾年中為我們在中國的發展做出了貢獻,令我們感到非常高興。

  • Please advance to the next slide.

    請前進到下一張幻燈片。

  • Already this year, we delivered multiple high-value Phase 3 readouts.

    今年我們已經提供了多個高價值的第三階段讀數。

  • LAURA expands the reach of Tagrisso in early-stage lung cancer.

    LAURA 擴大了 Tagrisso 在早期肺癌領域的應用範圍。

  • Calquence advances into mantle cell lymphoma with ECHO, and with AMPLIFY now has the potential to be the only medicine in frontline CLL approved for both fixed and extended durations of treatment.

    Calquence 與 ECHO 一起發展為套細胞淋巴瘤,而與 AMPLIFY 一起,現在有可能成為唯一獲準用於固定和延長治療時間的一線 CLL 藥物。

  • DESTINY-Breast06 broke new ground for Enhertu, moving it one line earlier into chemo naive metastatic breast cancer, and it showed clear benefit in HER2-ultralow disease.

    DESTINY-Breast06 為 Enhertu 開闢了新天地,使其提前一步進入未接受化療的轉移性乳癌治療領域,並且在 HER2 超低疾病中顯示出明顯的益處。

  • And Imfinzi is set to begin a new wave of growth in small cell lung cancer and bladder cancer following positive readouts for ADRIATIC and NIAGARA.

    在 ADRIATIC 和 NIAGARA 試驗取得積極進展後,Imfinzi 有望在小細胞肺癌和膀胱癌治療中掀起新一輪增長浪潮。

  • Finally, as shared earlier today, KOMET has potential to extend Koselugo used beyond pediatric and NF1 PN patients to adults, and WAYPOINT has the potential to bring a first-in-class mechanism of action to patients with severe nasal polyps.

    最後,正如今天早些時候所分享的那樣,KOMET 有可能將 Koselugo 的使用範圍從兒科和 NF1 PN 患者擴展到成人,而 WAYPOINT 有可能為患有嚴重鼻息肉的患者帶來一流的作用機制。

  • If approved, these opportunities represent over $5 billion in combined peak year revenues on a non-risk-adjusted basis.

    如果獲得批准,這些機會在未經風險調整的基礎上將帶來超過 50 億美元的總計高峰年收入。

  • With that, please advance to the next slide, and I will now hand over to Aradhana, who will take you through our financials.

    接下來,請進入下一張投影片,我會把時間交給 Aradhana,他將向大家介紹我們的財務狀況。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Thank you, Pascal, and hello, everyone.

    謝謝你,帕斯卡,大家好。

  • Next slide, please.

    請看下一張投影片。

  • I will start by highlighting our broad-based growth across our focus areas.

    我首先要強調的是我們在重點領域的廣泛成長。

  • As you can see on this slide, we delivered strong total revenue growth across the portfolio. with blockbusters in all key therapeutic areas, delivering strong growth in the year-to-date period.

    正如您在這張投影片上看到的,我們整個投資組合的總收入實現了強勁的成長。在所有關鍵治療領域擁有重磅藥物,年初至今實現了強勁成長。

  • Next slide, please.

    請看下一張投影片。

  • This is our reported P&L.

    這是我們報告的損益表。

  • Total revenue increased by 19% in the first nine months.

    前九個月總收入成長了19%。

  • Product sales also increased by 19%, with strong growth across major regions.

    產品銷售也成長了19%,主要地區均呈現強勁成長。

  • Alliance revenue increased by 50% to $1.5 billion, driven by increased sales for Enhertu and Tezspire in regions where our partners book product sales.

    聯盟收入成長了 50%,達到 15 億美元,這得益於我們的合作夥伴預訂產品銷售地區的 Enhertu 和 Tezspire 銷售額的成長。

  • In order to remain focused on our growth products, we undertake a regular portfolio prioritization.

    為了繼續專注於我們的成長產品,我們定期進行投資組合優先排序。

  • And in the third quarter, this resulted in an impairment and related charges for Andexxa.

    在第三季度,這導致 Andexxa 出現減損和相關費用。

  • Next slide, please.

    請看下一張投影片。

  • This is our core P&L.

    這是我們的核心損益。

  • As anticipated, our core product sales gross margin declined slightly in the third quarter versus the first half.

    正如預期的那樣,我們第三季核心產品銷售毛利率較上半年略有下降。

  • We anticipate a lower product sales gross margin in the fourth quarter, partly due to the seasonality of FluMist and increased Beyfortus supply to Sanofi following a very successful launch.

    我們預計第四季度產品銷售毛利率會下降,部分原因是 FluMist 的季節性以及 Beyfortus 在非常成功推出後對賽諾菲的供應增加。

  • We have previously said that for the full year, we expect a slightly lower product sales gross margin percentage compared to 2023.

    我們先前曾表示,預計全年產品銷售毛利率將較 2023 年略有下降。

  • Operating expenses increased by 15% year to date, well below the pace of total revenue growth.

    今年迄今,營業費用增加了 15%,遠低於總收入的成長速度。

  • R&D expenses increased by 18%, in part due to the integration of recent acquisitions, including Gracell, Fusion, and Amolyt for which we incurred additional costs this year.

    研發費用增加了 18%,部分原因是最近收購的公司包括 Gracell、Fusion 和 Amolyt,這些公司今年的收購產生了額外成本。

  • We've also accelerated a number of R&D projects and saw rapid patient enrollment across many of our clinical trials.

    我們也加速了許多研發項目的進程,並在許多臨床試驗中迅速招募患者。

  • This is expected to continue in the fourth quarter.

    預計這一趨勢將在第四季度持續。

  • For the full year, we still anticipate R&D costs to be towards the upper end of the previously indicated [low-20s%] range of total revenue.

    就全年而言,我們仍預期研發成本將接近先前預測的總收入範圍的上限[20%以下]。

  • This would imply a step-up in R&D costs in the fourth quarter.

    這意味著第四季研發成本將會加大。

  • SG&A costs increased by 13%, partly driven by investments behind our new launches and growth brands, including Airsupra, Breztri, and Truqap.

    銷售、一般及行政開支增加了 13%,部分原因是我們對新推出和成長品牌(包括 Airsupra、Breztri 和 Truqap)的投資。

  • However, as we've previously highlighted, while we expect to see some growth in SG&A costs in the fourth quarter, we do not anticipate it would be to the same extent as we saw in the fourth quarter of 2023.

    然而,正如我們之前強調的那樣,雖然我們預計第四季度銷售、一般及行政費用會有所增長,但我們預計不會達到 2023 年第四季那樣的幅度。

  • Core EPS of $6.12 represents a growth rate of 11%.

    核心每股收益 6.12 美元,成長率為 11%。

  • Recall that the comparative period last year benefited from almost $1.1 billion in one-time collaboration revenue and other operating income, impacting year-over-year growth rates.

    回想一下,去年同期受益於近 11 億美元的一次性合作收入和其他營業收入,影響了年成長率。

  • Please turn to the next slide.

    請翻到下一張投影片。

  • Our net cash inflow from operating activities improved by $989 million in the first nine months, driven by improved business performance.

    受業務績效改善的推動,前九個月我們的營運活動淨現金流入增加了 9.89 億美元。

  • We still expect CapEx for 2024 to increase by about 50% versus 2023 and have incurred $1.2 billion year to date.

    我們仍預期 2024 年的資本支出將較 2023 年增加約 50%,今年迄今已花費 12 億美元。

  • This includes investments in our new cell therapy manufacturing plant in Rockville, Maryland and a new manufacturing plant in Qingdao, China for our inhaled respiratory portfolio.

    這包括對我們位於馬裡蘭州羅克維爾的新細胞療法製造工廠和位於中國青島的吸入呼吸產品組合新製造工廠的投資。

  • Net debt increased by $3.8 billion, mainly reflecting the acquisitions completed earlier this year and $4.6 billion in dividend payments.

    淨債務增加了 38 億美元,主要反映了今年稍早完成的收購和 46 億美元的股息支付。

  • Our net debt-to-EBITDA ratio currently stands at 1.8 times.

    我們的淨債務與 EBITDA 比率目前為 1.8 倍。

  • As previously indicated, finance expenses are expected to be higher in 2024 compared to 2023, given the $6.5 billion of bond issuances earlier this year, which came at higher interest rates.

    如前所述,鑑於今年稍早發行了 65 億美元的債券,且利率較高,預計 2024 年的財務支出將高於 2023 年。

  • As Pascal mentioned, following strong performances from both product sales and alliance revenue year to date and increased confidence in achieving certain sales-based milestones, we are upgrading our fiscal year guidance today.

    正如帕斯卡所提到的,由於今年迄今產品銷售和聯盟收入表現強勁,並且對實現某些銷售里程碑的信心增強,我們今天上調了財年預期。

  • We now anticipate total revenue and core EPS to grow by high teens percentage at CER, an increase from our prior expectations for mid-teens growth, which was upgraded at half year.

    我們現在預計總收入和核心每股盈餘將以固定匯率 (CER) 計算,實現高雙位數成長,高於我們先前預期的中雙位數成長,該預期在半年內有所上調。

  • Heading into 2025, we expect to continue to see strong underlying revenue growth driven by indication expansion opportunities and continued strong global demand for our medicines, and are entering a catalyst-rich period for our company.

    展望 2025 年,我們預計,在適應症擴展機會和全球對我們藥品持續強勁的需求的推動下,基礎收入將繼續強勁增長,公司也將進入一個催化劑豐富的時期。

  • We remain focused on creating P&L leverage, and taken together, we are confident in our 2025 outlook.

    我們仍然專注於創造損益槓桿,總的來說,我們對 2025 年的前景充滿信心。

  • As usual, we will issue guidance for next year in February at our full year results.

    與往常一樣,我們將在二月的全年業績中發布明年的預期。

  • And with that, please advance to the next slide, and I will hand over to Dave, who will take you through Oncology performance.

    接下來,請進入下一張投影片,我將把時間交給 Dave,他將帶您了解腫瘤科的表現。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thank you, Aradhana.

    謝謝你,阿拉達納。

  • Next slide, please.

    請看下一張投影片。

  • In the first nine months of the year, Oncology total revenues grew 22% to $16 billion, driven by strong demand in the US, Europe, and emerging markets.

    今年前九個月,受美國、歐洲和新興市場強勁需求的推動,腫瘤學總收入成長 22%,達到 160 億美元。

  • Turning to our key medicine performance in the third quarter.

    談談我們第三季的主要藥品表現。

  • Tagrisso's global revenues grew 17% with sequential growth of 4%, reflecting strong demand for DoT and lengthening duration of therapy in the metastatic setting.

    Tagrisso 的全球收入成長了 17%,環比成長了 4%,這反映了對 DoT 的強勁需求以及延長轉移性治療時間。

  • In the US, initial adoption for FLAURA2 has been encouraging in the first nine months following launch.

    在美國,FLAURA2 在推出後的前九個月的初步採用情況令人鼓舞。

  • Calquence total revenues increased 25% in the third quarter, driven by sustained BTK inhibitor leadership in frontline CLL and continued international expansion.

    Calquence 第三季總營收成長了 25%,這得益於 BTK 抑制劑在前線 CLL 領域的持續領先地位以及持續的國際擴張。

  • Imfinzi delivered 16% and Imjudo 22% growth in the third quarter, supported by adoption GI cancers, Topaz has rapidly achieved peak market share as the standard of care in biliary tract cancer and HIMALAYA continues to make gains in advanced liver cancer.

    在胃腸道癌症治療領域應用的支持下,Imfinzi 在第三季度實現了16% 的增長,Imjudo 實現了22% 的增長,Topaz 作為膽道癌治療標準迅速實現了市場份額的峰值,HIMALAYA 在晚期肝癌治療領域持續取得進展。

  • As expected, we realized an impact from the two mandatory price reductions in Japan earlier this year, which is reflected in established rest of world performance in the first nine months.

    正如預期的那樣,我們感受到了今年早些時候日本兩次強制性降價的影響,這在前九個月世界其他地區的業績中有所體現。

  • We look forward to a new wave of Imfinzi growth driven by key indication expansion opportunities, including AEGEAN and once approved, ADRIATIC and NIAGARA, which will contribute meaningfully to peak year revenues.

    我們期待 Imfinzi 迎來新一輪成長,這得益於關鍵適應症擴展機會,包括 AEGEAN 以及一旦獲得批准的 ADRIATIC 和 NIAGARA,這些都將為高峰年收入做出重大貢獻。

  • Lynparza remains the leading PARP inhibitor globally across all tumor types, delivering product sales growth of 13%, driven primarily by demand growth in the US and Europe.

    Lynparza 仍然是全球所有腫瘤類型中領先的 PARP 抑制劑,產品銷售額成長 13%,主要受美國和歐洲需求成長的推動。

  • Enhertu is now the established standard of care across both HER2-positive and HER2-low metastatic breast cancer, delivering total revenue growth of 55% and sequential growth of 8% in the third quarter.

    Enhertu 目前已成為 HER2 陽性和 HER2 低轉移性乳癌的既定標準治療方法,第三季總收入成長 55%,較上季成長 8%。

  • We saw some spontaneous use in the chemo-naive setting following presentation of the DESTINY BREAST-06 data at ASCO and publication in the New England Journal of Medicine in September.

    在 DESTINY BREAST-06 研究數據於 ASCO 上公佈並於 9 月在新英格蘭醫學雜誌上發表後,我們看到了在未接受化療的環境中的一些自發性使用。

  • NCCN guideline inclusion and potential approval will be important catalysts for expanded adoption.

    NCCN 指南的納入和潛在批准將成為擴大採用的重要催化劑。

  • Finally, we continue to see encouraging early uptake in tumor agnostic, particularly in gynecologic tumors.

    最後,我們繼續看到腫瘤不可知論者的早期接受度令人鼓舞,特別是在婦科腫瘤領域。

  • Truqap delivered $125 million in the third quarter, supported by strong adoption in the biomarker altered population and further use in the late line setting.

    Truqap 在第三季實現了 1.25 億美元的營收,這得益於其在生物標誌物改變人群中的大力採用以及在後期環境中的進一步應用。

  • Since half year results, we received a number of key regulatory approvals, including AEGEAN and LAURA in the US, which accelerate Imfinzi and Tagrisso into early-stage lung cancer.

    自半年報以來,我們獲得了多項關鍵監管部門的批准,包括美國的 AEGEAN 和 LAURA,這加速了 Imfinzi 和 Tagrisso 進入早期肺癌治療領域。

  • In Europe, we received approval for Imfinzi and Lynparza in endometrial cancer.

    在歐洲,我們獲得了 Imfinzi 和 Lynparza 用於治療子宮內膜癌的批准。

  • And in China, we received additional Enhertu approvals in gastric and lung cancers.

    在中國,我們又獲得了 Enhertu 在治療胃癌和肺癌方面的批准。

  • Taken together with the performance of our existing medicines, these new indication expansion opportunities give us confidence in the continued growth of our global oncology portfolio in 2025.

    結合我們現有藥品的表現,這些新的適應症擴展機會使我們對2025年全球腫瘤產品組合的持續成長充滿信心。

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

    接下來,請進入下一張投影片,我將交給蘇珊來介紹本季的主要研發亮點。

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

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

  • Thank you, Dave.

    謝謝你,戴夫。

  • In September, we showcased important data at the World Congress on Lung Cancer and the European Society for Medical Oncology Congresses, with five presidential plan areas and eight simultaneous publications, including three in the New England Journal of Medicine.

    9月份,我們在世界肺癌大會和歐洲腫瘤內科學會大會上展示了重要數據,有5個總統計畫領域和8個同步出版物,其中3個發表在《新英格蘭醫學雜誌》上。

  • At ESMO, we presented the results from the Phase 3 NIAGARA trial of Imfinzi in a presidential session.

    在 ESMO,我們在主席會議上展示了 Imfinzi 第三階段 NIAGARA 試驗的結果。

  • This is the first perioperative IO regimen to show a significant improvement in overall survival versus standard of care in muscle invasive bladder cancer.

    這是第一個在肌肉層浸潤性膀胱癌治療中顯示出與標準治療相比整體存活率顯著提高的圍手術期骨內注射方案。

  • Together with the ongoing VOLGA Phase 3 trial of Imfinzi in combination with Enfortumab Vedotin, Imfinzi-based regimens will look to address the full spectrum of muscle invasive bladder cancer.

    結合正在進行的 Imfinzi 與 Enfortumab Vedotin 聯合治療的 VOLGA 3 期試驗,以 Imfinzi 為基礎的方案將尋求解決各種肌肉浸潤性膀胱癌。

  • We continue to advance our next-generation IO bio-specifics as well as our novel in-house ADC programs, and we shared key data updates on both of these, both World Congress and Lung Cancer and ESMO.

    我們繼續推進我們的下一代 IO 生物特異性以及我們新穎的內部 ADC 程序,並在世界大會、肺癌和 ESMO 上分享了這兩者的關鍵數據更新。

  • We've now initiated 10 Phase 3 trials with our IO bio-specifics volrustomig and rilvegostomig, and we continue to progress our late-stage ADC portfolio.

    目前,我們已經啟動了 10 項 IO 生物特異性藥物 volrustomig 和 rilvegostomig 的 3 期試驗,並且我們將繼續推進後期 ADC 產品組合。

  • Importantly, we shared a key data update for our novel QCS technology.

    重要的是,我們分享了我們新穎的 QCS 技術的關鍵數據更新。

  • A retrospective analysis of the TROPION Lung-01 data set shows a trip-2 QCS NMR biomarker is predictive of progression-free survival outcomes with Dato-DXD, and recent analysis shows it's also predictive of OS outcomes.

    TROPION Lung-01 資料集的回顧性分析表明,trip-2 QCS NMR 生物標記可以透過 Dato-DXD 預測無惡化存活期結果,最近的分析表明它也可以預測 OS 結果。

  • We look to prospectively validate this biomarker in multiple ongoing Phase 3 trials.

    我們希望在多個正在進行的 3 期試驗中前瞻性地驗證這種生物標記。

  • We believe that the novel advancement in the field of computational pathology will have applications across ADC portfolio, enabling better patient identification and unlocking opportunities in multiple tumor types.

    我們相信,計算病理學領域的新進展將應用於整個 ADC 產品組合,從而能夠更好地識別患者並釋放多種腫瘤類型的機會。

  • We will share data from the Phase 3 AMPLIFY trial at the American Society of Hematology meeting in December.

    我們將在 12 月的美國血液學會會議上分享第 3 階段 AMPLIFY 試驗的數據。

  • In this trial, fix duration Calquence in chronic lymphocytic leukemia delivered a clinically meaningful improvement in progression-free survival, a trend to overall survival and differentiated safety in an all-oral regimen.

    在本次試驗中,固定療程的 Calquence 治療慢性淋巴球白血病,在無惡化存活期、整體存活期趨勢和全口服方案的差異化安全性方面取得了具有臨床意義的改善。

  • HCPs prefer finite therapy for around 50% of patients, including those that are more fit or have IGHV mutations.

    HCP 傾向於對約 50% 的患者進行有限治療,包括身體更健康或有 IGHV 突變的患者。

  • AMPLIFY has the opportunity to drive BTK inhibitor class expansion in frontline CLL by offering both fixed and extended duration options as monotherapy and in combination.

    AMPLIFY 有機會透過提供固定和延長療程的單一療法和聯合療法來推動 BTK 抑制劑類別在一線 CLL 中的擴展。

  • Also at ASH, we'll be sharing new data for our CD19/CD3 T-cell engager, AZD-0486 in relapsed/refractory diffuse large B-cell lymphoma and in follicular lymphoma.

    此外,在 ASH 上,我們將分享我們的 CD19/CD3 T 細胞接合劑 AZD-0486 在復發/難治性瀰漫大 B 細胞淋巴瘤和濾泡性淋巴瘤中的新數據。

  • CD19 is expressed across a broader range of B-cells compared with CD20, and therefore, this asset has the opportunity to be differentiated from CD20 engagers.

    與 CD20 相比,CD19 在 B 細胞中表達範圍更廣,因此,該資產有機會與 CD20 接合體區分開來。

  • It was also designed to have lower affinity to CD3 with the hope that this improves tolerability compared with other engager platforms.

    它也被設計為對 CD3 具有較低的親和力,希望與其他接合平台相比能夠提高耐受性。

  • We believe that AZD-0486 has the potential to be a foundational therapy across multiple hematologic indications.

    我們相信 AZD-0486 有潛力成為多種血液疾病適應症的基礎療法。

  • Next slide, please.

    請看下一張投影片。

  • Tagrisso remains the backbone TKI for the treatment of EGFR mutated lung cancer, spanning early to late metastatic settings.

    Tagrisso 仍是治療 EGFR 突變肺癌的骨幹 TKI,涵蓋早期至晚期轉移性環境。

  • Earlier this year, we received US approval for the LAURA study in Stage 3 unresectable lung cancer, expanding Tagrisso's presence in early-stage disease.

    今年早些時候,我們獲得了美國批准進行針對 3 期不可切除肺癌的 LAURA 研究,擴大了 Tagrisso 在早期疾病中的影響力。

  • Last month, we read out the registrational Phase 2 SAVANNAH trial of Tagrisso with Orpathys in second-line EGFR mutated lung cancer.

    上個月,我們宣讀了 Tagrisso 與 Orpathys 在二線 EGFR 突變肺癌治療中的註冊性 2 期 SAVANNAH 試驗。

  • This oral regimen demonstrated a durable high response rate.

    此口服療法顯示出持久的高反應率。

  • Importantly, the addition of Orpathys for continued use of Tagrisso in the roughly one-third of patients that have high met expression.

    重要的是,對於大約三分之一的高met表達患者,添加Orpathys可以繼續使用Tagrisso。

  • We've shared these data with regulatory agencies and await the readout of the confirmatory Phase 3 SAFFRON trial in the second half of next year.

    我們已經與監管機構分享了這些數據,並等待明年下半年確認性第 3 階段 SAFFRON 試驗的結果。

  • SAVANNAH is one of several trials that looks to explore novel combinations which can extend Tagrisso across multiple lines of therapy.

    SAVANNAH 是幾項旨在探索可將 Tagrisso 擴展到多種療法的新組合的試驗之一。

  • We're also exploring Tagrisso and Dato-DXD in first and second-line settings with the TROPION Lung14 and 15 trials.

    我們也透過 TROPION Lung14 和 15 試驗來探索 Tagrisso 和 Dato-DXD 在第一線和第二線治療的應用。

  • We see potential to replace systemic chemotherapy whilst maintaining Tagrisso use for patients with EGFR mutated lung cancer.

    我們看到了對於 EGFR 突變肺癌患者維持 Tagrisso 使用的同時替代全身化療的潛力。

  • Finally, I'd like to provide an update on the TROPION Lung01 filing.

    最後,我想提供有關 TROPION Lung01 文件的最新資訊。

  • Following discussions with the FDA, we submitted a biologics license application for approval in later line EGFR mutated non-small cell lung cancer.

    經過與 FDA 討論,我們提交了生物製劑許可申請,​​以獲得後期 EGFR 突變非小細胞肺癌的批准。

  • With the encouragement of the FDA, we've also applied for breakthrough therapy designation for this indication.

    在FDA的鼓勵下,我們也針對該適應症申請了突破性治療認證。

  • In parallel, we've decided to withdraw the application for the broader non-squamous, non-small cell indication.

    同時,我們決定撤回針對更廣泛的非鱗狀、非小細胞適應症的申請。

  • The FDA has noted the favorable benefit risk profile in EGFR mutated lung cancer based primarily on the data from the single-arm TROPION Lung05 with supportive data from the TROPION pan-Tumor-01 and the randomized data from the TROPION-Lung01 EGFR-mutated subset.

    FDA 已註意到 EGFR 突變肺癌的有利獲益風險概況,這主要基於單臂 TROPION Lung05 的數據、TROPION pan-Tumor-01 的支持數據以及 TROPION-Lung01 EGFR 突變子集的隨機數據。

  • The ongoing TROPION-Lung15 study will serve as a confirmatory trial.

    正在進行的 TROPION-Lung15 研究將作為一項驗證性試驗。

  • Also, we plan to conduct an additional registrational trial in the second line TROP2-QCS-NMR biomarker positive population, complementing the ongoing AVANZAR and TROPION 10 trials in first-line non-small cell lung cancer.

    此外,我們計劃在二線 TROP2-QCS-NMR 生物標記陽性人群中進行額外的註冊試驗,以補充正在進行的一線非小細胞肺癌 AVANZAR 和 TROPION 10 試驗。

  • We remain committed to our ongoing Dato-DXd program in lung cancer and look forward to next year's readout for Avanza, the first Phase 3 data for Dato-DXd in first-line lung cancer.

    我們將繼續致力於正在進行的肺癌 Dato-DXd 項目,並期待明年 Avanza 的讀數,這是 Dato-DXd 在肺癌一線治療中的首個 3 期數據。

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

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

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Thank you so much, Susan.

    非常感謝,蘇珊。

  • Next slide, please.

    請看下一張投影片。

  • Our biopharmaceuticals medicines delivered total revenue of $15.9 billion in the first nine months of 2024, representing growth of 20%.

    我們的生物製藥藥品在 2024 年前九個月的總收入為 159 億美元,成長了 20%。

  • In the third quarter, total revenue increased 25%, with every biopharma therapy area growing in every major region.

    第三季度,總收入成長了 25%,各主要地區的每個生物製藥治療領域均成長。

  • CVRM total revenue increased 20% in the third quarter.

    CVRM第三季總營收成長了20%。

  • Farxiga delivered 27% growth with double-digit growth in all major regions, driven by continued market leadership in the expanding SGLT2 class.

    Farxiga 在所有主要地區實現了 27% 的增幅,增幅達到兩位數,這得益於其在不斷擴大的 SGLT2 類別中繼續保持市場領先地位。

  • In the third quarter, our recently launched medicine for ATTR polyneuropathy Wainua grew 44% sequentially to $23 million with prescribers coming from a broad range of specialties.

    第三季度,我們最近推出的治療 ATTR 多發性神經病 Wainua 的藥物銷售額環比增長 44%,達到 2,300 萬美元,處方人員來自各行各業。

  • Wainua secured positive CHMP opinion in Europe during the quarter as well as multiple approvals in other markets.

    本季度,Wainua 在歐洲獲得了 CHMP 的積極評價,並在其他市場獲得了多項批准。

  • Our R&I business is expected to be a substantial driver of our growth through 2030.

    我們的研發業務預計將成為我們到 2030 年成長的重要推動力。

  • R&I delivered total revenue of $2 billion in the quarter, an increase of 29%.

    R&I 本季總營收為 20 億美元,成長 29%。

  • Growth was particularly strong in the United States at 43% and Europe at 30%, reflecting increased demand for our biologic and in health medicines.

    美國的成長尤其強勁,達到 43%,歐洲的成長達到 30%,反映出對我們的生物製劑和保健藥物的需求增加。

  • The strong growth momentum we have seen for the Tezspire in Breztri continued with both medicines on track to achieve around $1 billion sales in global sales in 2024.

    我們看到 Breztri 中 Tezspire 的強勁成長勢頭持續存在,這兩種藥物預計在 2024 年實現約 10 億美元的全球銷售額。

  • The long-term outlook for Breztri is very promising with potential to expand into asthma, and we're also progressing the development of our next-generation propellant with near zero global warming potential.

    Breztri 的長期前景非常光明,有潛力擴展到氣喘領域,我們也在推動全球暖化潛勢值接近零的下一代推進劑的開發。

  • Our ongoing Outcomes trial is the only in the class to examine both pulmonary and cardiac endpoints and, if successful, could be transformative for this medicine.

    我們正在進行的結果試驗是同類試驗中唯一一項同時檢查肺部和心臟終點的試驗,如果成功,可能會對這種藥物產生變革性的影響。

  • Our other in-health medicines, Symbicort and Airsupra are also experiencing strong demand.

    我們的其他保健藥物 Symbicort 和 Airsupra 的需求也十分強勁。

  • Well, it is unclear to what extent Symbicort's recent growth in the United States will continue in 2025.

    目前還不清楚 Symbicort 在美國近期的成長動能在 2025 年會持續到何種程度。

  • We expect to see continued strong demand in the emerging markets.

    我們預計新興市場的需求將持續強勁。

  • Airsupra revenues grew 50% sequentially and the launch is progressing very well with more than 50,000 healthcare practitioners in the US having prescribed Airsupra to date.

    Airsupra 營收季增 50%,上市進展順利,迄今為止,美國已有超過 5 萬名醫療從業人員開立了 Airsupra 處方。

  • Lastly, we are very pleased to see V&I return to growth in the quarter, with a 49% increase in total revenue.

    最後,我們很高興看到 V&I 在本季度恢復成長,總收入成長了 49%。

  • Demand for Beyfortus is strong, supported by real-world evidence of Beyfortus value in preventing infant hospitalizations and also the recent clinical data from the HARMONY trial, which demonstrates its sustained efficacy to 180 days.

    Beyfortus 的需求強勁,這得益於 Beyfortus 在預防嬰兒住院方面的現實證據,以及 HARMONY 試驗的最新臨床數據,該數據證明其療效可持續長達 180 天。

  • We are highly encouraged to see such a strong performance from all areas of biopharmaceuticals in the year-to-date, and we anticipate this growth momentum will continue into 2025.

    我們非常高興地看到今年迄今為止生物製藥各個領域都表現如此強勁,我們預計這種成長勢頭將持續到 2025 年。

  • We I will now hand over to Sharon to discuss the latest developments from the biopharmaceuticals pipeline.

    現在我將把時間交給 Sharon 來討論生物製藥管道的最新進展。

  • Next slide, please.

    請看下一張投影片。

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

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Thank you, Ruud.

    謝謝你,魯德。

  • Today, I'm excited to share more about our ambitions to build the next wave of transformative medicines addressing cardiovascular, renal, and metabolic diseases.

    今天,我很高興能與大家分享我們打造下一波針對心血管、腎臟和代謝疾病的變革性藥物的雄心。

  • We have established a robust foundation with Farxiga, our leading SGLT2 inhibitor in heart failure, chronic kidney disease, and Type 2 diabetes, and we are progressing a number of key NMEs.

    我們已憑藉 Farxiga(我們在心臟衰竭、慢性腎臟病和 2 型糖尿病領域領先的 SGLT2 抑制劑)建立了堅實的基礎,並且正在推進多種關鍵的 NME。

  • We remain focused on delivering novel targeted mono-therapies, including baxdrostat our selective aldosterone synthase inhibitor, which we believe has the potential to be the first-in-class medicine for uncontrolled hypertension, and we look forward to a Phase 3 readout next year.

    我們將繼續專注於提供新型標靶單一療法,包括我們的選擇性醛固酮合成酶抑制劑巴曲司他,我們相信它有可能成為治療不受控制的高血壓的同類首創藥物,我們期待明年的第三階段結果。

  • Earlier this year, we presented results from our Phase 1 trial for AZD-0780, our oral PCSK9 inhibitor, demonstrating an additional 52% reduction LDL-C on top of standard-of-care statins.

    今年早些時候,我們公佈了口服 PCSK9 抑制劑 AZD-0780 的 I 期試驗結果,結果證明,與標準他汀類藥物相比,LDL-C 又降低了 52%。

  • Furthermore, we are investigating multiple modalities in cardiac amyloidosis, including two molecules for ATTR cardiomyopathy, Eplontersen, a TTR gene silencer, and ALXN-2220, a TTR protein depleter, which has the potential to address the broad spectrum of cardiac amyloidosis.

    此外,我們正在研究心臟澱粉樣變性的多種治療方法,包括兩種用於治療ATTR 心肌病變的分子、Eplontersen(一種TTR 基因沉默劑)和ALXN-2220(一種TTR 蛋白質消耗劑),它有可能解決廣泛的心臟澱粉樣變性問題。

  • To pioneer in an evolving landscape, we have intentionally built our pipeline to investigate novel combinations to simultaneously target complex conditions and address comorbidities.

    為了在不斷發展的領域中開拓創新,我們特意建立了我們的管道,以研究新的組合,從而同時針對複雜的情況並解決合併症。

  • We recently presented early data from three assets across our weight management pipeline at Obesity Week earlier this month.

    我們在本月初的肥胖週上展示了我們體重管理產品線中三項資產的早期數據。

  • Promising Phase 1 data from AZD-5004, our small molecule oral GLP-1 receptor agonist demonstrated good target engagement, safety and tolerability.

    我們的小分子口服 GLP-1 受體激動劑 AZD-5004 的第 1 階段數據令人鼓舞,它表現出良好的標靶參與度、安全性和耐受性。

  • As a once-daily option, AZD-5004 is being developed as both the monotherapy as well as in combination with other small molecules in our portfolio such as dapagliflozin and AZD-0780, our oral PCSK9 inhibitor.

    作為每日一次的治療選擇,AZD-5004 既可以作為單一療法開發,也可以與我們產品組合中的其他小分子(如達格列淨和口服 PCSK9 抑制劑 AZD-0780)共同開發。

  • We are rapidly progressing AZD-5004 in Phase 2b trials in Type 2 diabetes and obesity or overweight.

    我們正在快速推進 AZD-5004 在第 2 型糖尿病和肥胖症或超重方面的 2b 期試驗。

  • Data from AZD-6234 our once-weekly long-acting amylin agonist peptide, also demonstrated encouraging safety and tolerability as well as a robust profile designed to promote fat specific weight loss while preserving lean muscle mass.

    我們的每週一次的長效胰島澱粉樣勝肽激動劑勝肽AZD-6234 的數據也顯示出令人鼓舞的安全性和耐受性,以及旨在促進脂肪特定減重同時保持肌肉質量的強效特性。

  • We have progressed AZD-6234 into Phase 2b to evaluate body weight reduction for those living with obesity or overweight.

    我們已將 AZD-6234 推進至 2b 階段,以評估肥胖或超重患者的體重減輕效果。

  • Additionally, we believe the triple mechanism combination of AZD-6234 with AZD-9550, our GLP-1 glucagon dual agonist has the potential to achieve optimal weight loss, lean mass sparing, and organ protection.

    此外,我們相信 AZD-6234 與 AZD-9550 的三重機制組合,我們的 GLP-1 胰高血糖素雙重激動劑有潛力實現最佳的減肥、維持瘦體重和保護器官。

  • We are working at pace to deliver the next wave of transformative medicines across cardiovascular, renal, and metabolic diseases, across a range of modalities and pathways designed to address the inter-connectiveness of disease.

    我們正在努力透過一系列旨在解決疾病相互關聯性的治療方式和途徑,推出針對心血管、腎臟和代謝疾病的下一波變革性藥物。

  • Please move to the next slide.

    請移至下一張投影片。

  • Last week, we announced positive results from the WAYPOINT Phase 3 trial of Tezspire in patients with chronic rhinosinusitis with nasal polyps.

    上週,我們宣布了 Tezspire 對患有鼻息肉的慢性鼻竇炎患者的 WAYPOINT 第 3 期試驗的積極結果。

  • There is a significant burden and unmet need for patients living with nasal polyps with over 7 million patients treated for this disease, of which 3 million are uncontrolled.

    鼻息肉患者負擔沉重,且未滿足的需求,全球有超過 700 萬名患者接受該疾病治療,其中 300 萬名患者未獲得控制。

  • Tezspire demonstrated statistically significant and clinically meaningful reductions in both co-primary endpoints, reducing the size of nasal polyps and the level of diesel congestion.

    Tezspire 在兩個共同主要終點方面表現出了統計學上顯著和臨床意義上的降低,減少了鼻息肉的大小和柴油阻塞的程度。

  • We look forward to sharing these data with regulatory authorities and at an upcoming medical meeting.

    我們期待與監管機構和即將召開的醫學會議分享這些數據。

  • Beyond nasal polyps, we have several other Phase 3 trials ongoing or announced across multiple indications, including severe asthma, eosinophilic esophagitis, and COPD, and we look forward to updating you on our progress.

    除了鼻息肉之外,我們還在進行或宣布了其他幾項 3 期試驗,涉及多種適應症,包括嚴重氣喘、嗜酸性食道炎和慢性阻塞性肺病,我們期待向您通報我們的進展。

  • And with that, please move to the next slide, and I will hand over to Marc to cover our rare disease portfolio.

    接下來,請翻到下一張投影片,我將交給馬克介紹我們的稀有疾病產品組合。

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

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

  • Thank you, Sharon.

    謝謝你,莎倫。

  • Can I get the next slide, please?

    我可以看一下下一張投影片嗎?

  • Rare disease grew 14% to $6.4 billion in the first nine months of the year, driven by growth in neurology indications, increased patient demand, and continued global expansion.

    今年前九個月,罕見疾病市場成長了 14%,達到 64 億美元,這主要得益於神經學適應症的成長、患者需求的增加以及全球擴張的持續。

  • Ultomiris achieved its first blockbuster quarter with revenue growing at 35%, primarily driven by neurology indication.

    Ultomiris 取得了第一個轟動的季度,收入增長了 35%,主要得益於神經病學適應症的推動。

  • The NMOSD launch is progressing very well.

    NMOSD 啟動進展非常順利。

  • And by the end of the year, we expect the majority of patients in major markets will have switched from Soliris to Ultomiris.

    到今年年底,我們預計主要市場的大多數患者將從 Soliris 轉向 Ultomiris。

  • In Europe, we saw a minimal increase of Soliris biosimilar utilization across PNH and atypical HUS.

    在歐洲,我們發現 Soliris 生物相似藥在 PNH 和非典型 HUS 患者中的使用率略有增加。

  • Beyond complement, Strensiq and Koselugo grew 21% and 39%, respectively, driven by continued patient demand and new launches.

    除了補充藥物之外,受持續的患者需求和新產品的推動,Strensiq 和 Koselugo 分別增加了 21% 和 39%。

  • We are highly encouraged by the strong performance from our rare disease medicine in the year to date, and we anticipate this growth momentum to continue into 2025.

    我們對今年迄今罕見疾病藥物的強勁表現感到非常鼓舞,我們預計這種成長勢頭將持續到 2025 年。

  • Please advance to the next slide.

    請前進到下一張幻燈片。

  • Today, we announced positive results from the Phase 3 KOMET trial in adult patients with NF1 PN, the largest placebo-controlled Phase 3 trial ever conducted in the disease.

    今天,我們宣布了針對 NF1 PN 成年患者的 3 期 KOMET 試驗的積極成果,這是迄今為止針對該疾病進行的最大規模的安慰劑對照 3 期試驗。

  • NF1 PN is a rare progressive genetic condition impacting multiple body systems characterized by benign tumors that develop along nerve sheaths throughout the body.

    NF1 PN 是一種影響多個身體系統的罕見進行性遺傳疾病,其特徵是沿著全身神經鞘發展的良性腫瘤。

  • NF1 PN affects over 60,000 in both the US and the EU, 80% of whom we estimate are adults.

    NF1 PN 影響著美國和歐盟超過 60,000 人,其中我們估計 80% 是成年人。

  • In the KOMET trial, Koselugo showed statistically significant and clinically meaningful reduction in patient tumor volumes as well as an encouraging effect across pain severities, rapid response from patients, and low discontinuation rates.

    在 KOMET 試驗中,Koselugo 顯示出統計學上顯著且具有臨床意義的腫瘤體積減少,以及對疼痛嚴重程度的令人鼓舞的效果、患者的快速反應和低停藥率。

  • These data support the potential to explain Koselugo into the adult population.

    這些數據支持將 Koselugo 解釋為成年人口的可能性。

  • We look forward to sharing the data with regulators globally and will present at an upcoming conference.

    我們期待與全球監管機構分享數據,並將在即將舉行的會議上展示。

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

    接下來,請進入下一張投影片,我將把發言權交還給 Pascal。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc.

    謝謝你,馬克。

  • Next slide, please.

    請看下一張投影片。

  • In addition to the high-value trial readouts that I mentioned at the start of this call, we are entering a remarkable catalyst rich path for our company.

    除了我在本次電話會議開始時提到的高價值試驗讀數之外,我們還在為公司進入一條富有催化劑的非凡道路。

  • Within the coming year, we will see the results of significant indication expansion opportunities for our marketed medicines, including Truqap, Enhertu, Imfinzi, and Fasenra as well as pivotal trial readouts for several important potential best-in-class novel medicines shown here on this slide.

    在未來一年內,我們將看到我們上市藥物的重大適應症擴展機會的結果,包括 Truqap、Enhertu、Imfinzi 和 Fasenra,以及本頁上顯示的幾種重要的潛在同類最佳新藥的關鍵試驗讀數滑動。

  • We're also making excellent progress advancing key disruptive technologies with potential to drive growth well beyond 2030.

    我們也正在推動關鍵顛覆性技術方面取得了巨大進展,這些技術有可能推動 2030 年以後的成長。

  • And we look forward to multiple earlier-stage data readouts over the course of 2025.

    我們期待在 2025 年獲得多個早期階段的數據讀數。

  • Next slide, please.

    請看下一張投影片。

  • As Aradhana mentioned earlier, our strong delivery in the first nine months of this year, together with our upgraded full year 2024 guidance sets a strong foundation for continued growth next year.

    正如 Aradhana 之前提到的,我們今年前九個月的強勁交付量,加上我們升級的 2024 年全年預期,為明年的持續成長奠定了堅實的基礎。

  • And while we will provide formal guidance with full year results in February, we're confident that the headwinds we anticipate next year will be substantially offset by global demand for our portfolio of medicines.

    雖然我們將在二月提供全年業績的正式指引,但我們相信,我們預計明年面臨的阻力將被全球對我們藥品組合的需求大幅抵消。

  • The strong commercial performance, together with continued pipeline delivery and our focus on profitability means we are on track to achieve the strategic conditions later out at our Investor Day this past May.

    強勁的商業表現,加上持續的通路交付和對獲利能力的關注,意味著我們有望在今年 5 月的投資者日實現策略條件。

  • We remain confident in our ability to generate $80 billion in total revenue by 2030.

    我們仍有信心在 2030 年實現 800 億美元的總收入。

  • And as a reminder, this is a risk-adjusted number.

    提醒一下,這是一個經過風險調整的數字。

  • We are also managing our P&L to deliver the [mid-30s%] operating margin by 2026, as we previously communicated.

    正如我們之前所說的,我們也正在管理我們的損益表,以在 2026 年實現 [35% 中段] 的營業利潤率。

  • Of course, pipeline regeneration is critical to delivering leading growth and long-term value creation.

    當然,管道再生對於實現領先成長和長期價值創造至關重要。

  • To that point, we've launched six NMEs towards our goal of at least 20 by 2030.

    目前,我們已經推出了 6 款 NME,而我們的目標是到 2030 年推出至少 20 款 NME。

  • And with that, please advance to the next slide, and we will go to the Q&A.

    接下來,請進入下一張投影片,我們進入問答環節。

  • As Andy mentioned at the start of the call, please limit the number of questions you ask to allow others a fair chance to participate.

    正如安迪在通話開始時提到的,請限制您提出的問題數量,以便其他人有公平的參與機會。

  • (Event Instructions) And with that, we'll move to the first question, which is from James Gordon at JPMorgan.

    (活動說明) 現在,我們進入第一個問題,來自摩根大通的詹姆斯戈登 (James Gordon)。

  • Over to you, James.

    交給你了,詹姆斯。

  • James Gordon - Analyst

    James Gordon - Analyst

  • James Gordon, JPMorgan.

    摩根大通的詹姆斯戈登。

  • First question was US election implications and where you're investing.

    第一個問題是美國大選的影響力以及您的投資領域。

  • So do you see any impact from the US presidential election on Astra's business in terms of higher tariffs or maybe lower corporate tax or anything else?

    那麼,您是否認為美國總統大選會對阿斯特拉的業務產生影響,例如提高關稅、降低企業稅或其他什麼影響?

  • And I saw the USD3.5 billion investment in manufacturing research.

    我看到了對製造業研究的35億美元的投資。

  • Is there any connection there?

    這其中有什麼關聯嗎?

  • Are you going to shift more of your investment into the US?

    您會把更多的投資轉移到美國嗎?

  • Is that even more of a focus now?

    現在是否更加關注這一點?

  • I assume, for instance, the UK election doesn't make much difference, and that's going to be potentially an area of less investment?

    例如,我認為英國大選不會帶來太大影響,這可能會成為投資較少的領域?

  • And the second question was confidence in the 2025 outlook.

    第二個問題是對2025年前景的信心。

  • So if I look the 2025 consensus of the new updated 2024 implied EPS level is looking for low double-digit EPS growth.

    因此,如果我看 2025 年的共識,新更新的 2024 年隱含每股盈餘水準正在尋求低兩位數的每股盈餘成長。

  • So how comfortable are you with that growth outlook?

    那麼您對於這種成長前景感覺如何?

  • I can hear comments on top-line strength and leverage over SG&A, but also we've had a pull forward of the Lynparza milestone.

    我可以聽到有關營收實力和銷售、一般及行政開支槓桿的評論,但我們也已經提前實現了 Lynparza 的里程碑。

  • There's questions on China, IRA, financial expense, and maybe the election depending on what you said on the first question.

    問題涉及中國、愛爾蘭共和軍 (IRA)、財務支出,也許還有選舉,這取決於你在第一個問題上所說的內容。

  • So should we be a bit more cautious than that in 2025?

    那麼,到 2025 年,我們是否應該更加謹慎?

  • Or is that achievable maybe?

    或者說這是可以實現的嗎?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Okay.

    好的。

  • Thanks, James.

    謝謝,詹姆斯。

  • So the first question, the pharmaceuticals typically are not subject to import duties.

    第一個問題是,藥品通常不受進口關稅限制。

  • Having said that, it's academic in our case because we don't import pharmaceuticals into the US from China.

    話雖如此,但對我們來說這只是理論問題,因為我們不是從中國進口藥品到美國。

  • So that is really a question that doesn't apply to us because we source our products for the US.

    所以這個問題其實並不適用於我們,因為我們的產品來自美國。

  • We source them either from the US directly or from Europe typically.

    我們通常直接從美國或歐洲採購。

  • So there's really no issue of sourcing products from China.

    因此,從中國採購產品實際上並沒有問題。

  • And so that's the first point.

    這是第一點。

  • And as we explained in the past, we've really tried over the last few years to build supply chains that can, on the one hand, supply what you might call the Western world, US, Europe, and a few others.

    正如我們過去所解釋的那樣,過去幾年我們確實努力建立供應鏈,一方面可以供應所謂的西方世界、美國、歐洲和其他一些國家。

  • And then we have a separate supply chain for China and some of the emerging markets.

    我們針對中國和一些新興市場有單獨的供應鏈。

  • So that's the answer to the first question.

    這就是第一個問題的答案。

  • The second question -- actually -- on your first question about the US elections, I mean the -- the reason we invest very substantially in the US is that we all know the US is a very important market, both in terms of providing our medicines to patients, but also in terms of innovation.

    第二個問題——實際上——關於你第一個關於美國大選的問題,我的意思是——我們在美國進行大量投資的原因是我們都知道美國是一個非常重要的市場,無論是在為我們提供不僅在藥物供應方面,在創新方面亦是如此。

  • And we really want to be at the heart of this country in terms of manufacturing but also R&D.

    我們確實希望成為這個國家製造業和研發業的核心。

  • I mean, we are building this new site in Kendall Square in Boston because it's an important location for research and development.

    我的意思是,我們正在波士頓的肯德爾廣場建造這個新站點,因為它是重要的研發地點。

  • Now we see the economy should actually continue to grow strongly in the US next year and the year after.

    現在我們看到,明年和後年美國經濟實際上應該會繼續強勁成長。

  • And then a number of economy -- a number of participants in the economy seem to obey that too.

    然後,許多經濟——許多經濟參與者似乎也遵循這一點。

  • And a strong economy will support a strong healthcare, which, of course assumably will also support the delivery of medicines.

    強勁的經濟將支持強勁的醫療保健,當然,這也將支持藥品的傳遞。

  • So all of that makes us makes us really enthusiastic about the US market.

    所有這些都讓我們對美國市場充滿熱情。

  • In our plan, the US should increase its participation to our total revenue.

    在我們的計劃中,美國應該增加對我們總收入的參與。

  • The other area that is growing very nicely, of course, the emerging markets out of China.

    當然,另一個成長良好的領域是中國以外的新興市場。

  • Now in terms of your other question with 2025, it's relatively simple, actually.

    至於您關於 2025 年的另一個問題,實際上它相對簡單。

  • I mean, look at where we are today, we are growing almost 20% in top line, right?

    我的意思是,看看我們今天的狀況,我們的營業額成長了近20%,對吧?

  • So we've got enormous momentum moving into the Q4, but also next year.

    因此,我們在進入第四季度以及明年都將擁有巨大的發展勢頭。

  • So we've got this momentum into next year running at sort of 20% growth rate.

    因此,我們保持了這一勢頭,明年的成長率將達到 20% 左右。

  • Now we know what the headwinds are.

    現在我們知道阻力是什麼了。

  • I mean we know about IRA, we know about VBP, Farxiga in China.

    我的意思是我們了解 IRA,我們了解中國的 VBP 和 Farxiga。

  • We don't know exactly when, but we know it's going to happen next year.

    我們不知道具體時間,但我們知道它將在明年發生。

  • And so those are headwinds.

    這些都是阻力。

  • But on the other hand, we have enormous momentum across the entire portfolio but also across the entire world.

    但另一方面,我們的整個投資組合乃至整個世界都擁有巨大的發展動能。

  • So I'm not saying next year, we will go by the same amount of this year, of course, not.

    因此,我並不是說明年我們的支出會和今年一樣多,當然不會。

  • But even if you decelerate this a little bit, and then you assume some leverage because we've been working on P&L leverage for many years, it's relatively easy to get to a conclusion that confirms what Aradhana was saying before.

    但即使你稍微放慢速度,然後假設一些槓桿,因為我們已經研究損益槓桿很多年了,所以相對容易得出一個結論,證實 Aradhana 之前所說的話。

  • We are very confident with the outlook for next year, not only for next year, but the year after, actually.

    我們對明年的前景非常有信心,實際上不僅對明年,而且對後年。

  • So net-net is we are actually confident for the outlook next year.

    因此整體而言,我們對明年的前景充滿信心。

  • Aradhana, do you want to add anything to that?

    Aradhana,您還有什麼要補充嗎?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • No, I think you covered it very well.

    不,我認為你已經講得很好了。

  • And also just to make sure the investments we announced in the US today, we've been working on them for several years, and the incremental investment that was announced is partly this year, partly the next two years, and it's really driven by the growth and the momentum that we see, whether it's in clinical trials and clinical trial supply or the cell therapy.

    另外,為了確保我們今天在美國宣布的投資,我們已經為這些投資工作了好幾年,宣布的增量投資一部分是今年的,一部分是未來兩年的,這實際上是由我們看到的增長和勢頭,無論是在臨床試驗和臨床試驗供應還是細胞療法領域。

  • And so it's really a continued process.

    所以這其實是一個持續的過程。

  • And I know we made the announcement today since we are in New York, but that's been part of the plan.

    我知道我們今天在紐約宣布了這個消息,但這是計劃的一部分。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • And maybe just going back to the US question is if you think about -- I mean if you look at our position around the world, in most cases, we are in the top three companies in most markets -- not in the US.

    也許回到美國的問題,如果你想想——我的意思是如果你看看我們在全球的地位,在大多數情況下,我們在大多數市場上都位居前三名——而不是在美國。

  • And the reason is the US market is the market that actually rewards innovation the most.

    原因在於美國市場其實是最鼓勵創新的市場。

  • But to do this, to be rewarded for your innovation, you have to have new products, and that's what we've done with oncology, but there's more to come outside of oncology in the next few years.

    但要做到這一點,要讓你的創新獲得回報,你必須有新產品,這就是我們在腫瘤學領域所做的,但未來幾年,在腫瘤學之外還會有更多產品問世。

  • And so that's why we believe that the share of global revenue coming out of the US over the next few years should grow because our participation in the US and hopefully, our ranking in the US will improve.

    因此,我們相信未來幾年美國在全球收入中的份額應該會成長,因為我們在美國的參與度以及我們在美國的排名都會提高。

  • Should we move to the next question, Richard Parkes?

    我們應該轉到下一個問題嗎,理查德帕克斯?

  • Richard Parkes - Analyst

    Richard Parkes - Analyst

  • Richard Parkes from BNP Paribas Exane.

    法國巴黎銀行證券部 (BNP Paribas Exane) 的 Richard Parkes。

  • So a couple of questions.

    有幾個問題。

  • Firstly, just one for you, Pascal.

    首先,帕斯卡,我只想問你一個問題。

  • Just wondered if you could comment on what you would suggest investors assume in terms of materiality of impact to your China business at this stage from the investigation?

    我只是想知道您是否可以評論一下,就目前調查對您在華業務的重大影響而言,您建議投資者做出何種假設?

  • Obviously, we've all got very little visibility on China, so is it safer to assume there will be some negative implications?

    顯然,我們對中國的了解非常有限,因此是否可以更安全地假設它會有一些負面影響?

  • And how would you characterize the materiality of that at this stage?

    那麼您現階段如何描述它的實質內容呢?

  • I'm just wondering what you would assume if you had to present an updated 10-year plan to the Board tomorrow for the China outlook.

    我只是想知道,如果您明天必須向董事會提交一份針對中國前景的最新十年計劃,您會作何設想。

  • Then secondly, on Dato-DXd on for Susan.

    其次,Dato-DXd 是 Susan 的。

  • I just wondered if there was -- if was anything that was raised in -- during the FDA review that investors should be aware of that maybe undermine your confidence in Dato-DXd or the TROP2 to biomarker.

    我只是想知道,在 FDA 審查期間是否有任何投資者應該注意的問題,這可能會削弱您對 Dato-DXd 或 TROP2 生物標誌物的信心。

  • Obviously, the decision to withdraw the filing raises question of the confidence in your hypothesis of where the drug works well.

    顯然,撤回申請的決定使人們對您關於該藥物療效的假設的可信度產生了質疑。

  • I'm just wondering if we should assume that or was the FDA's requirement for approval simply a higher bar than you originally assumed?

    我只是想知道我們是否應該假設這一點,或者 FDA 的批准要求是否比您最初假設的要高?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So the first question, Richard, thank you.

    所以第一個問題,理查德,謝謝你。

  • For China, I think really, the answer to your question is, it's too early to judge.

    對中國來說,我認為對你的問題的答案是,現在判斷還為時過早。

  • I think it's reasonable to assume that there will be some impact.

    我認為有理由認為會產生一些影響。

  • But today, we cannot judge that.

    但今天我們無法對此作出判斷。

  • I mean it's much too early.

    我的意思是現在還太早。

  • We don't have enough data.

    我們沒有足夠的數據。

  • We need to wait a little longer and see the trend.

    我們需要再等一段時間,看看趨勢如何。

  • And on top of it, then we would have to see if there was an impact, is it a short-lasting or long-lasting impact.

    除此之外,我們還必須觀察是否會產生影響,是短期影響還是長期影響。

  • So much too early to judge.

    現在判斷還為時過早。

  • But I think maybe what I can say is that China today is about 12%, 13% of our total revenue.

    但我想我可以說的是,目前中國市場約占我們總收入的 12% 至 13%。

  • As I said, the US will continue to grow.

    正如我所說,美國將繼續增長。

  • Europe is growing.

    歐洲正在發展。

  • China will grow for sure.

    中國肯定會發展。

  • But next year, we know we have Farxiga VBP, and so certainly next year, the growth in China, in any case, will be slower than what we see this year, which this year is a very good growth, by the way.

    但明年,我們知道我們有 Farxiga VBP,所以明年,無論如何,中國的成長肯定會比今年慢,順便說一句,今年的成長非常好。

  • So we have -- the assumption is the share of sales is not going to be the 20% we saw a few years ago, we are at 12%, 13% today and the rest of the world will grow much more.

    因此,我們假設銷售份額不會達到幾年前的 20%,而是今天的 12%、13%,而世界其他地區的成長幅度將更大。

  • So I guess what I'm saying is we will navigate this difficult period.

    所以我想說的是,我們將度過這個困難時期。

  • And we think we can actually manage and to continue to grow across the world even if there was some impact in China.

    我們認為,即使在中國受到一些影響,我們仍然能夠在全球範圍內實現並繼續成長。

  • We hope there won't be a time impact.

    我們希望不會對時間造成影響。

  • And certainly, the team in the country in China is working very hard to continue moving our products.

    當然,中國團隊正在非常努力地繼續銷售我們的產品。

  • We know our research and development in China is very appreciated.

    我們知道我們在中國的研發成果受到高度讚賞。

  • We are probably -- I think we are the largest company in terms of R&D investment.

    我們可能是-我認為我們是研發投入最大的公司。

  • This is well-appreciated.

    我們對此深表讚賞。

  • So we believe that we should be able to manage this difficult period.

    因此我們相信我們能夠渡過這個困難時期。

  • But again, as I said, very difficult to comment at a very early stage.

    但正如我所說,在早期階段很難發表評論。

  • Susan, do you want to take the second one?

    蘇珊,你想搭第二個嗎?

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

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

  • So thanks for the question.

    感謝您的提問。

  • So obviously, with every review, there's ongoing discussions.

    顯然,每一次審查都會引發持續的討論。

  • I think it's fair to say that over the last period of time, the FDA has been increasingly interested in looking at subgroups within clinical trials.

    我認為可以公平地說,在過去的一段時間裡,FDA 對研究臨床試驗中的亞群越來越感興趣。

  • And this isn't the only example of that.

    這並不是唯一的例子。

  • The FDA is interested in the particular subgroups where the greatest benefit is seen.

    FDA 關注的是那些能帶來最大益處的特定亞群。

  • And of course, there's not just within the TL01 study, but obviously, within the single-arm TL05 study. really very robust activity that we've seen within the patients with actionable genomic alterations and in particular, those with EGFR mutations.

    當然,這不僅存在於 TL01 研究中,而且顯然也存在於單臂 TL05 研究中。我們在具有可操作基因組改變的患者,特別是具有 EGFR 突變的患者中看到了非常強勁的活性。

  • So I think what you're seeing is a reflection on trying to focus initially on the subgroup, where is the greatest benefit.

    因此,我認為您所看到的是對最初嘗試關注子群體的反思,因為這是最大的利益所在。

  • But I think there's also interest in the potential of the patients that have the biomarker positive subgroup that we've seen in the TROPION-Lung01.

    但我認為,人們對我們在 TROPION-Lung01 中看到的具有生物標記陽性亞組的患者的潛力也感興趣。

  • We've had ongoing discussions about the potential route for validation of that biomarker.

    我們一直在討論驗證該生物標記的潛在途徑。

  • Of course, we've incorporated those plans into our ongoing Phase 1 trials which AVANZAR, as I've said, is the first one that we'll read out next year.

    當然,我們已經將這些計劃納入了我們正在進行的第 1 階段試驗中,正如我所說,AVANZAR 是我們明年將宣讀的第一個試驗。

  • But TROPION-Lung10 is another example.

    但TROPION-Lung10是另一個例子。

  • And then again, in combination with osimertinib in TROPION-Lung14 and 15 studies.

    然後再次在 TROPION-Lung14 和 15 研究中與奧希替尼合併使用。

  • So that we build out really a robust set of indications for Dato-DXd in lung cancer.

    這樣,我們就為 Dato-DXd 在肺癌治療中建立了一套真正強而有力的適應症。

  • So your question was about confidence in the profile that we have with Dato-DXd.

    所以您的問題是關於我們對 Dato-DXd 的概況的信心。

  • As I've said a number of times, I think we've learned a lot from the TROPION-Lung01 data set, not just about the level of activity in the EGFR mutant, but this potential for the broader patient population.

    正如我多次說過的,我認為我們從 TROPION-Lung01 數據集中了解到了很多信息,不僅僅是關於 EGFR 突變體的活動水平,還包括對更廣泛患者群體的潛力。

  • These were things that we didn't understand at the time that the TROPION-Lung01 study was designed.

    這些都是我們在設計 TROPION-Lung01 研究時所不了解的。

  • And that's the nature of development that you learn as you go.

    這就是發展的本質,邊走邊學。

  • So what we've done is taken those learnings and adapted the program to maximize that potential benefit.

    因此,我們所做的就是吸收這些經驗並調整計劃,以最大限度地發揮潛在利益。

  • What I would say is in terms of looking to the first line, which is obviously the biggest indication that we've got for non-small cell lung cancer, that given the safety and efficacy that we've seen from the TROPION-Lung02 and the TROPION-Lung04 studies, for combination and the ability to combine with platinum-based chemotherapy as well as IO, we're very confident about that profile.

    我想說的是,就第一線而言,這顯然是我們對非小細胞肺癌的最大適應症,鑑於我們從 TROPION-Lung02 中看到的安全性和有效性, TROPION-Lung04 研究,對於聯合治療以及與鉑類化療和IO 結合的能力,我們對此非常有信心。

  • And also, as I indicated as well, the biomarker data that we've seen in TROPION-Lung01, we've looked in other data sets as well.

    而且,正如我所指出的,我們在 TROPION-Lung01 中看到的生物標記數據,我們也在其他數據集中查看過。

  • We also think we've got evidence that, that will translate across different data sets, including from internal data sets in earlier line settings as well.

    我們還認為,我們有證據表明,這將在不同的資料集之間進行轉換,包括來自早期線路設定中的內部資料集。

  • I think the overall profile that we have with Dato-DXd and the potential to maximize the benefit using the biomarker in broader patient populations is something that we're now probably increasingly confident about given the latest data that have emerged.

    我認為,鑑於最新出現的數據,我們對 Dato-DXd 的總體概況以及在更廣泛的患者群體中使用生物標誌物最大化益處的潛力現在可能越來越有信心。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Susan.

    謝謝你,蘇珊。

  • So the next question is from Sachin, Bank of America

    下一個問題來自美國銀行的 Sachin

  • .

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • Same two topics if I may, please.

    如果可以的話,請分享兩個相同的主題。

  • So firstly on a Dato, you indicated [in lung] with FDA around changing AVANZAR

    因此,首先,您曾向 FDA 表示,[在肺部] 需要改變 AVANZAR

  • [stat plan].

    [統計計劃]。

  • I just wonder how far progressed you are with that and whether the TL01 debate

    我只是想知道你在這方面取得了多大進展,以及 TL01 辯論是否

  • [influenced at all].

    [完全沒有影響]。

  • And the second one is just back on '25, just get a bit more color if I could, from Pascal around there.

    第二個就在 '25 上,如果可以的話,從那邊的 Pascal 那裡得到更多一點的顏色。

  • You've listed two main headwinds, Farxiga VBP and IRA.

    您列出了兩個主要不利因素,Farxiga VBP 和 IRA。

  • But you just give us your best quantification or expectations around those.

    但您只需針對這些問題給出最好的量化或期望。

  • We have asked a question Crestor did better than expected on VBP.

    我們曾問過一個問題,Crestor 在 VBP 上的表現比預期好。

  • IRA, you've historically framed as manageable to neither seem like material headwinds, the existing high teens growth adjustment revenues could continue to double digit for next year, so just any perspectives there.

    IRA,你過去一直將其視為可控的,既不像是實質性的逆風,現有的高十幾歲的增長調整收入明年可能會繼續保持兩位數,所以只是任何觀點。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So maybe let me cover the second one and then I think, Susan, we can go back to that, too.

    所以也許讓我講一下第二個問題,然後我想,蘇珊,我們也可以回到這個問題。

  • And Rod and Dave if you want to comment on the.

    如果你們想對此發表評論,請 Rod 和 Dave 留言。

  • So on the China side, what you should expect for Farxiga is what we saw with Crestor, which is a decline and then stabilization in the growth because our plan is to do with Farxiga what we did with Crestor.

    因此在中國方面,您應該對 Farxiga 的預期與 Crestor 的情況一樣,即先是下降,然後穩定增長,因為我們的計劃是像對待 Crestor 那樣對待 Farxiga。

  • And there is a market for these products. that patients actually buy directly online with an electronic prescriptions essentially and then get it delivered to their home.

    這些產品有市場。患者實際上是透過電子處方直接在線購買,然後送貨上門。

  • Now the sales will not be at the same level as they are today, for sure, just like happened with Crestor, but we believe we can go down and then grow again and keep Farxiga for quite some time to come.

    現在,銷售額肯定不會達到今天的水平,就像 Crestor 的情況一樣,但我們相信我們可以先下降然後再次成長,並在未來相當長的一段時間內保持 Farxiga 的銷售量。

  • But next year, you should expect a decline.

    但明年,你應該預期會出現下降。

  • I mean we can't give you a specific indication for 2025 Farxiga, but you should expect a substantial decline.

    我的意思是,我們無法為您提供 2025 年 Farxiga 的具體跡象,但您應該預期會大幅下降。

  • And then Ruud, do you want to cover IRA and anything, Dave, you would want to add?

    然後 Ruud,你想談談 IRA 和其他內容嗎?

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yeah, of course.

    是的,當然。

  • And once again, currently, we are not assuming that Farxiga in our guidance for this year that Farxiga will be in the VBP, it hasn't been announced, but that's a clear assumption and let's see how it works for 2025, as Pascal mentioned Sachin.

    再次重申,目前,我們並沒有假設 Farxiga 會進入 VBP,這還沒有宣布,但這是一個明確的假設,讓我們看看它在 2025 年的表現如何,正如 Pascal 提到的那樣薩欽。

  • Regarding the IRA, I think it's a little bit of a mixed bag.

    至於愛爾蘭共和軍,我認為它有點好壞參半。

  • On one hand, we know that the out-of-pocket cost will be lower.

    一方面,我們知道自付費用將會更低。

  • It will also be smooth over the full year in the course of 2025.

    2025 年全年也將一切順利。

  • So patient adherence probably will be better than what we have seen in the past.

    因此,患者的依從性可能會比我們過去看到的更好。

  • But of course, the liability for some of our products, and I will hand over in a second to Dave regarding the oral oncology products, we will see a certain impact.

    但當然,對於我們的某些產品的責任,我馬上就會將有關口腔腫瘤產品的責任移交給戴夫,我們會看到一定的影響。

  • But when we will give the guidance in the beginning of 2025 that will be part of the way we will guide for that specific year.

    但是,當我們在 2025 年初給予指導時,這將成為我們針對該特定年份的指導方式的一部分。

  • But overall, I think it's fair to say that from a biopharma perspective, the IRA impacts will be manageable.

    但總的來說,我認為從生物製藥的角度來看,IRA 的影響是可控的。

  • We have good programs in place to drive further volume.

    我們已製定了良好的計劃來進一步推動銷售。

  • We've seen that clearly with the Symbicort performance but Farxiga is still performing very well in the US market.

    我們從 Symbicort 的表現中清楚地看到了這一點,但 Farxiga 在美國市場的表現仍然非常好。

  • And we don't think that as well substantially slowdown in the course of 2025.

    我們也不認為 2025 年會大幅放緩。

  • Dave?

    戴夫?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Sachin, I think that again, we've talked about this in the past, but I also believe that IRA is manageable coming into next year.

    薩欽,我認為,我們過去已經談論過這個問題,但我還相信 IRA 在明年是可控的。

  • We know that IRA has resulted in important improvements in affordability for Medicare patients in the United States.

    我們知道,IRA 大大提高了美國醫療保險患者的負擔能力。

  • That's resulted in increased adherence also lower reliance on free drug programs.

    這不僅提高了遵守規定的可能性,也降低了對免費藥物計畫的依賴。

  • We've seen that.

    我們已經看到了。

  • I think that you've also seen that in other earnings announcements that have come out from other companies on their oral if you will, kind of more expensive specialty medicines.

    我想您也在其他公司發布的關於其口服(如果您願意的話)更昂貴的特種藥物的收益公告中看到了這一點。

  • And you've seen that across the board.

    你已經全面地看到了這一點。

  • Obviously, next year, we take on the 20% liability in the catastrophic phase for the first time.

    顯然,明年我們將首次承擔災難階段的20%的責任。

  • So that's a mechanic that we haven't experienced in 2024.

    所以這是我們在 2024 年還未曾經歷過的機制。

  • But also within that, the affordability improves even further.

    但同時,其可負擔性也進一步提高。

  • And I think that we would hope and expect more patients to be able to afford to be on commercial drug and the capping is something that can benefit.

    我認為我們希望並期望更多的患者能夠負擔得起商業藥物,而限制劑量是可以讓人受益的。

  • And I think importantly, our oncolytics, Pascal talked about this, as did Susan in the slides.

    我認為重要的是,我們的溶瘤醫生帕斯卡談到了這一點,蘇珊在幻燈片中也談到了這一點。

  • We've got really excellent growth drivers on Tagrisso and Calquence.

    Tagrisso 和 Calquence 擁有非常出色的成長動力。

  • And I think that, that's where I'm focusing my efforts in the year ahead on making sure that we get those to patients as quickly and rapidly as we can.

    我認為,這就是我未來一年的努力重點,確保我們能盡快、迅速地將這些藥物送到病人手中。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • It really is important, as Dave said, to consider the new indications because as we launch those new indications for instance, Tagrisso or Calquence, patients will have the ability to benefit from those indications without having to ask for free products.

    正如戴夫所說,考慮新的適應症確實很重要,因為當我們推出這些新的適應症時,例如 Tagrisso 或 Calquence,患者將能夠從這些適應症中受益,而不必要求免費的產品。

  • So we really have in part only, of course, a partial shield to the negative effect of IRA.

    因此,我們實際上只能部分抵禦 IRA 的負面影響。

  • That's why we keep -- I mean, we've never quantified it externally, but we've said many times, it's manageable, and we continue to believe it's manageable -- 0having gone through our planning process now and our budgeting process, we continue to believe it's manageable.

    這就是為什麼我們保持——我的意思是,我們從來沒有對外量化過,但我們已經說過很多次了,這是可控的,我們仍然相信這是可控的——我們已經完成了現在的規劃過程和預算過程,我們繼續相信這是可以控制的。

  • There is an online question coming from Christopher.

    克里斯多福在線提問。

  • Oh sorry, go ahead.

    噢,抱歉,請說。

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

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

  • So Sachin had a -- thank you for the question on data about AVANZAR.

    所以 Sachin 感謝您提出有關 AVANZAR 數據的問題。

  • So just as a reminder, once we saw the initial results from TROPION-Lung01, we made some modifications to AVANZAR.

    所以提醒一下,一旦我們看到 TROPION-Lung01 的初步結果,我們就對 AVANZAR 進行了一些修改。

  • We've increased the sample size, 1,280 patients. we capped the number of squamous patients, so that we ensured that we had good power within the non-squamous patient population, in both the ITT and biomarker groups within Avanza.

    我們已將樣本量擴大至 1,280 名患者。我們限制了鱗狀細胞癌患者的數量,這樣我們就能確保在 Avanza 中的 ITT 組和生物標記組中,我們在非鱗狀細胞癌患者群體中都擁有良好的療效。

  • And to answer your question specifically, have we discussed these changes with the FDA?

    具體回答您的問題,我們是否與 FDA 討論過這些變化?

  • Yes, of course, we've discussed those changes with the FDA.

    是的,當然,我們已經與 FDA 討論了這些變化。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • (multiple speakers) Dato, you've covered, but the question is -- the second question is Lynparza, and it's an online question.

    (多位發言者)Dato,您已經講到了,但問題是——第二個問題是 Lynparza,這是一個線上問題。

  • It says, what are you seeing in ovarian in the wake of PReMA bombing on OS.

    它所說的是,在 PReMA 對 OS 進行轟炸之後,你在卵巢中看到了什麼。

  • It's probably more a question for Dave actually.

    事實上這可能更像是戴夫的問題。

  • What share do you think you can capture?

    您認為您能佔據多少份額?

  • And how confident are you in a positive outcome from MONO-OLA as well as DUO-O and one might we expect to see OS results.

    您對 MONO-OLA 和 DUO-O 的正面結果有多大信心?

  • So a bit of Dave and a bit for Susan.

    所以,有點像戴夫,有點像蘇珊。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Why don't I start first on Lynparza?

    我為什麼不先開始使用 Lynparza?

  • I think very importantly, when we take a look at the year, following second half of last year, where the class, particularly in the US, was really undergoing a lot of second line headwinds from FDA mandated changes to labels.

    我認為非常重要的是,當我們回顧去年下半年之後的一年時,該類別,特別是在美國,確實因 FDA 強制要求更改標籤而遭受了許多二線阻力。

  • We've now seen in 2024, two consecutive quarters of sequential growth in Q2 and Q3.

    我們現在看到 2024 年第二季和第三季連續兩季連續成長。

  • We've got the highest levels of sales for Lynparza globally that we've experienced to date and historically, and I think we're on a good growth trajectory.

    到目前為止,Lynparza 的全球銷售額達到了歷史最高水平,我認為我們正處於良好的成長軌跡。

  • That growth is predominantly coming from ovarian cancer, and from breast cancer, and that's true across the globe.

    這種增長主要來自卵巢癌和乳癌,全球範圍內都是如此。

  • Of course, within Europe, we are seeing uptake within prostate cancer, less on prostate within the US.

    當然,在歐洲,我們看到攝護腺癌的發生率上升,而在美國,攝護腺癌的發生率較低。

  • Certainly, the PReMA news represents an important opportunity.

    毫無疑問,PReMA 新聞代表著一個重要的機會。

  • We do already have pretty substantial market share in that ovarian setting.

    我們在卵巢領域已經佔有相當大的市場份額。

  • But we're also at a place with this medicine where we are leaving no stone unturned.

    但我們在研發這種藥物時也已經竭盡全力。

  • And that represents an opportunity and one where we believe that we've got a great story to tell and a differentiated one with MONO-OLA1, and we'll stay focused in on that to continue on our growth trajectory for Lynparza.

    這代表著一個機會,我們相信我們有一個精彩的故事可以講述,並且 MONO-OLA1 是一個差異化的故事,我們將繼續專注於此,以繼續 Lynparza 的成長軌跡。

  • Do you want to address the MONO-OLA1 and the DUO-O?

    您想解決 MONO-OLA1 和 DUO-O 的問題嗎?

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

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

  • The DUO-O, the mature OS is anticipated in 2025.

    成熟的作業系統 DUO-O 預計將於 2025 年推出。

  • I don't think we've guided more specifically before that.

    我認為我們在此之前沒有提供過更具體的指導。

  • And of course, that will be event-driven for OS.

    當然,這將是由作業系統事件驅動的。

  • And in a number of our ovarian cancer studies with Lynparza, we faced slowing event rates.

    在我們針對 Lynparza 進行的許多卵巢癌研究中,我們面臨事件發生率下降的問題。

  • So it depends a little bit on that event rate coming in about the timing of that.

    所以這在一定程度上取決於事件發生率和發生的時間。

  • For the MONO-OLA study, I also think that the latest clinical trial appendix is the latest timelines for that. which is really in the second half of next year.

    對於 MONO-OLA 研究,我也認為最新的臨床試驗附錄是其最新的時間表。其實是在明年下半年。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Next question is from Gonzalo Artiach at Danske Bank.

    下一個問題來自丹麥銀行的 Gonzalo Artiach。

  • Over to you, Gonzalo.

    交給你了,貢薩洛。

  • It sounds like we don't have the connection to Gonzalo.

    聽起來我們與 Gonzalo 沒有任何關聯。

  • Let's move to Steve Scala at Cowen.

    讓我們來看看 Cowen 公司的 Steve Scala。

  • Over to you, Steve, and we'll come back to Gonzalo maybe later.

    交給你了,史蒂夫,我們稍後再回來談論貢薩洛。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Two questions.

    兩個問題。

  • Dave, you spoke on the second quarter call about a robust Enhertu acceleration in the second half of the year.

    戴夫,您在第二季度電話會議上談到了 Enhertu 在下半年的強勁增長。

  • In Q3, do you think a robust acceleration was achieved?

    在 Q3 中,您認為實現了強勁的加速嗎?

  • And should we look for further acceleration in Q4?

    我們是否應該期待第四季進一步加速?

  • So that's the first question.

    這是第一個問題。

  • Second question is, could you give us some clarity on the likely regulatory timing of Dato-DXd with the addition of TL05?

    第二個問題是,您能否向我們說明一下添加 TL05 後 Dato-DXd 的可能監管時間?

  • For instance, when was it filed?

    例如,什麼時候提交的?

  • And given FDA is familiar with some of the data and presumably the filing strategy, this new filing strategy was their idea, could approval come by mid-2025?

    鑑於 FDA 熟悉部分數據和可能的備案策略,這種新的備案策略是他們的想法,到 2025 年中期能獲得批准嗎?

  • Or is that completely unrealistic?

    或者說這完全不切實際?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • So Steve, on your question on Enhertu, I think we remain very focused in the quarter on driving against both DESTNY-Breast03 in the HER2-positive setting as well as with DESTINY-Breast04.

    所以史蒂夫,關於你關於 Enhertu 的問題,我認為我們在本季度仍然非常專注於在 HER2 陽性環境中對抗 DESTNY-Breast03 以及 DESTINY-Breast04。

  • What I was hoping that we would see in the quarter, and we haven't seen yet is an inclusion of DESTINY-Breast06 into the guidelines.

    我希望我們能在本季度看到將 DESTINY-Breast06 納入指南,但我們還沒有看到。

  • I think that, that is a catalyst that is important to be able to really see a change in the growth trajectory within ENHERTU.

    我認為,這是一個重要的催化劑,能夠真正看到 ENHERTU 內部成長軌跡的變化。

  • That maybe begs the question, then why do I think that we haven't seen yet the guidelines change yet.

    這也許引出了一個問題,那麼為什麼我認為我們還沒有看到指導方針的改變。

  • And I think that the primary reason in the answer on that is that I do think that in instances of a new biomarker population where ultra-low is, I think, while something we've talked a lot about, something that is really a new population.

    我認為回答這個問題的主要原因是,我確實認為,在新的生物標記群體中,超低水平是,雖然我們已經討論了很多,但我認為,這確實是一種新現像人口。

  • I think oftentimes, the guidelines wait both for FDA and also for the pathology community to play more of a leading role in helping the definition there.

    我認為,很多時候,指南既需要等待 FDA,也需要病理學界發揮更大的主導作用來幫助定義。

  • So I look forward to Enhertu going through a change in trajectory as we're able to both see 06 within both the guidelines and also then ultimately approval, so that we can promote to it.

    因此,我期待 Enhertu 能夠經歷軌蹟的改變,因為我們能夠在指導方針內看到 06,並最終獲得批准,以便我們能夠推廣它。

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

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

  • And to answer the question on Dato, we submitted really very recently.

    為了回答有關 Dato 的問題,我們最近才提交了申請。

  • And normally, of course, we announce a file acceptance.

    當然,通常情況下,我們會宣布文件被接受。

  • But given the special circumstances around Dato, we've made an exception to make that announcement now.

    但考慮到拿督的特殊情況,我們現在破例宣布這一消息。

  • As I said in my prepared remarks, with the encouragement of the FDA, we have also applied for breakthrough therapy designation.

    正如我在準備好的發言中所說,在 FDA 的鼓勵下,我們也申請了突破性療法認定。

  • If breakthrough therapy designation were to be granted, that would also give us encouragement about the opportunity for a potential priority review.

    如果突破性療法認定獲得批准,我們也將對潛在的優先審查機會充滿信心。

  • So we'll have to wait and see for that file acceptance and for the breakthrough therapy designation decision in order to be clearer on the time lines.

    因此,我們必須等待該文件被接受以及突破性療法指定決定,以便更清楚地了解時間表。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Susan.

    謝謝你,蘇珊。

  • So next question is from Rajan Sharma at Goldman Sachs.

    下一個問題來自高盛的拉詹·夏爾馬。

  • Rajan Sharma - Analyst

    Rajan Sharma - Analyst

  • So just on Farxiga VBP.

    因此只需使用 Farxiga VBP。

  • So you mentioned that you're expecting the inclusion in 2025, but I think you previously expected it in 2024, which hasn't materialized.

    所以您提到您預計會在 2025 年納入,但我認為您預計之前會在 2024 年納入,但這並沒有實現。

  • So it would be just helpful to understand why that could be '25 and not, in fact, '26 or beyond.

    因此,了解為什麼這個數字可能是 25 年,而不是 26 年或更晚,將會很有幫助。

  • And then second question is just on operating margins into next year.

    第二個問題是關於明年的營業利益率。

  • I realize you're not going to guide on the numbers specifically, but just your comfort around current consensus estimates.

    我知道您不會具體指導數字,而只是根據當前的普遍估計來提供指導。

  • So the trajectory is implying a slightly stronger accretion into '25 and then more moderated accretion into '26.

    因此,該軌跡暗示到 25 年吸積會稍微強勁一些,到 26 年吸積會更加溫和。

  • Is that how you're expecting it to materialize?

    您是否期望它能實現?

  • Or should we expect that to be more linear?

    或者我們應該期望它更加線性?

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yeah, let me take the first question.

    是的,讓我回答第一個問題。

  • So first of all, once again, we have assumed our guidance assumed that Farxiga will not be included in VBP 10.

    因此首先,我們再次假設我們的指導假設 Farxiga 不會包含在 VBP 10 中。

  • And in fact, the list hasn't been announced yet.

    事實上,名單尚未公佈。

  • So we are still waiting for that.

    所以我們仍在等待這一點。

  • And of course, then the big ticket item is when VBP 11 will be announced.

    當然,最重要的事情就是 VBP 11 的發佈時間。

  • And at this stage, I think it's too speculative in order to give any answer on that.

    目前,我認為對此做出任何回答都過於推測。

  • It can be the beginning of next year, but it can also be later.

    可以是明年年初,也可以是更晚。

  • So we are a little bit in the dark there.

    所以我們在這方面有點不清楚。

  • So overall, we will give hopefully a little bit more guidance in the beginning of 2025 when we have our first full year results.

    因此總體而言,我們希望在 2025 年初獲得第一個全年業績時提供更多指導。

  • But so far, we are not able to provide any more clarity for Farxiga in 2025.

    但到目前為止,我們還無法為 2025 年的 Farxiga 提供更多明確資訊。

  • It will not happen.

    這不會發生。

  • I think that's highly likely now in the course of 2024.

    我認為,到 2024 年,這種情況發生的可能性很高。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • And then your question on 2025 and 2026 operating margins.

    然後您關於 2025 年和 2026 年營業利潤率的問題。

  • Again, we obviously will give guidance when we do our full year results and guide to 2025.

    再次,我們顯然會在公佈全年業績和 2025 年指引時給予指引。

  • But what I'd point out is if you look at the third quarter results and the revenue growth rate at 21% versus the operating expense growth at 15% and the SG&A growth only at 9%, that gives you a sense of the focus on operating leverage and obviously growing SG&A at a much slower pace than the revenue growth, while at the same time, continuing to invest in the R&D portfolio.

    但我想指出的是,如果你看看第三季的業績,營收成長率為21%,而營運費用成長率為15%,銷售、一般及行政費用成長率僅9%,你就會感覺到營業槓桿和銷售、一般及行政費用的成長速度明顯低於收入成長速度,同時繼續對研發組合進行投資。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Aradhana.

    謝謝你,阿拉達納。

  • So Ranjan, I mean, essentially, keep in mind, we will continue working on leverage.

    所以 Ranjan,我的意思是,從本質上講,請記住,我們將繼續努力利用槓桿。

  • And again, if you look at what kind of top line growth we can deliver next year based on the momentum we have and considering the headwinds and you look at a bit of leverage, you can immediately conclude that we are very comfortable with the outlook in 2025.

    再說一次,如果你看看我們明年能夠實現什麼樣的營收成長,基於我們目前的勢頭,考慮到逆風,再看看一些槓桿,你就可以立即得出結論,我們對前景非常滿意。 。

  • I mean, so we are in a good place really based on the momentum we have today.

    我的意思是,根據我們今天的勢頭,我們確實處於一個很好的位置。

  • Etzer Darout at BMO.

    BMO 的 Etzer Darout。

  • Over to you, Etzer.

    交給你了,Etzer。

  • Etzer Darout - Analyst

    Etzer Darout - Analyst

  • Great.

    偉大的。

  • Yeah, just one quick follow-up question on Dato-DXd.

    是的,關於 Dato-DXd 只有一個快速後續問題。

  • Just wondering if maybe there's any read-through to the TROPION-Breast01 upcoming regulatory decision in first half 2025.

    只是想知道是否有人對 2025 年上半年即將出台的 TROPION-Breast01 監管決定進行任何解讀。

  • Just given that you think about the application, statistical benefit on PFS, directional OS benefit, I guess, similar to the non-squamous cell population from TROPION-Lung01.

    只是考慮到您考慮的應用、PFS 的統計效益、定向 OS 效益,我猜,類似於 TROPION-Lung01 的非鱗狀細胞群。

  • Just wondered if there's any read-through there.

    只是想知道那裡是否有任何讀物。

  • And then on the QCS biomarker strategy and the decision, the QCS biomarker strategy have any impact on the decision on TROPION-Lung01?

    然後關於QCS生物標記策略和決策,QCS生物標記策略對TROPION-Lung01的決策有什麼影響?

  • And is there any read-through positive or negative on AVANZAR based on those decisions?

    基於這些決定,對 AVANZAR 有何正面或負面的解讀?

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

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

  • Okay.

    好的。

  • So the TROPION-Breast01 filing is still under review.

    因此TROPION-Breast01申請仍在審核中。

  • Again, what we've seen there is a clinically meaningful improvement in progression-free survival.

    再次,我們看到無惡化存活期有臨床意義的改善。

  • We've said at the high-level results that we didn't see static overall survival in that setting.

    我們在高層結果中說過,我們在該環境下沒有看到靜態的總體生存率。

  • And again, I think in the context of that setting, there's both crossover with patients treated with other ADCs in that setting, which I think has the potential to affect the later readouts such as that.

    而且,我認為在這種情況下,與接受其他 ADC 治療的患者存在交叉,我認為這有可能影響後續的讀數。

  • So we're really in ongoing discussions with the FDA, and I don't have any new updates at the moment.

    所以我們實際上正在與 FDA 進行討論,目前我還沒有任何新的消息。

  • The regulatory decision is really expected in the first half of next year, as you've said.

    正如您所說,監管決定確實有望在明年上半年出台。

  • The QCS biomarker in terms of did the biomarker strategy affect the discussions about the plans for the indication?

    就 QCS 生物標記策略而言,生物標記是否影響了針對適應症計劃的討論?

  • No, I don't believe so.

    不,我不這麼認為。

  • What we said is when we saw the TL01 data, that biomarker would require prospective validation in another trial.

    當我們看到 TL01 數據時,我們說該生物標記需要在另一項試驗中進行前瞻性驗證。

  • So I don't think it's affected that.

    所以我不認為這會受到什麼影響。

  • I do think there's strong interest across the community, investigators included in this potential for identifying a patient population that's particularly sensitive.

    我確實認為整個社會都對此有著濃厚的興趣,研究人員也對此有潛力辨識出特別敏感的患者群體。

  • And I think it does help to explain, as we said before, the difference by histology in non-squamous versus squamous population.

    我認為它確實有助於解釋我們之前所說的非鱗狀細胞癌和鱗狀細胞癌的組織學差異。

  • So I think there's a high level of interest in that, but we've always said it would require prospective validation, and that's why we've had those plans and discussions with regulatory authorities about the plans for validation of that biomarker in subsequent studies.

    因此我認為人們對此有很高的興趣,但我們一直表示這需要前瞻性驗證,這就是為什麼我們制定了這些計劃並與監管機構討論了後續研究中驗證該生物標誌物的計劃。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Susan.

    謝謝你,蘇珊。

  • Simon Baker at Redburn.

    雷德伯恩的西蒙貝克。

  • Simon, over to you.

    西蒙,交給你了。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Two questions if I may.

    我可以問兩個問題。

  • The first one on China, but on the bit of China where you do have visibility, I just wonder if you could update us on your usual dialogue with Chinese authorities.

    第一個問題是關於中國的,但關於您在中國確實有了解的部分,我只是想知道您是否可以向我們介紹一下您與中國當局的慣常對話。

  • Is that unaffected by what's going on with these investigations?

    這不受這些調查進展的影響嗎?

  • I mean you clearly have a very strong relationship with the authorities over there.

    我的意思是,你顯然與那裡的當局保持著非常密切的關係。

  • Has that been disrupted at all by what we're seeing here?

    我們現在看到的情況有沒有擾亂這一點?

  • And then just a very quick ride on the end.

    然後很快就騎行結束了。

  • Any color on that ex-China emerging markets growth on a regional country basis would be quite handy.

    任何有關中國以外新興市場地區國家成長情況的資訊都將非常有用。

  • And then secondly, a question that we've received quite a lot in the last couple of weeks, which is on the question of buybacks.

    其次,過去幾週我們收到了很多關於回購的問題。

  • I know your view over more than a decade has been very clear on that.

    我知道,十多年來,您對此的看法一直非常明確。

  • But in light of recent moves and the egregious reaction to what's happened in China, is the buyback any more attractive at sub 100 than it was at 130?

    但考慮到最近的舉措以及對中國事件的強烈反應,低於 100 點的回購是否比 130 點的回購更有吸引力?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • That's great.

    那太棒了。

  • Thanks, Simon.

    謝謝,西蒙。

  • The first question, maybe I can quickly comment on China and Ruud, you can comment on -- well, China, if you want, but also the emerging markets.

    第一個問題,也許我可以快速評論中國和魯德,你可以評論一下——好吧,如果你願意的話,中國,還有新興市場。

  • And then Aradhana, you'll take the buyback, knowing that, of course, this will be a Board decision, but certainly, Aradhana can give you some early thoughts.

    然後,Aradhana,你將進行回購,當然,這將是董事會的決定,但當然,Aradhana 可以給你一些早期的想法。

  • So far, we haven't been approached.

    到目前為止,還沒有人與我們接洽。

  • So in terms of the case, as we said before, we haven't got any details as to the cases.

    因此就案件而言,正如我們之前所說,我們還沒有獲得有關案件的任何詳細資訊。

  • As a company, we haven't been approached.

    作為一家公司,我們還未被聯繫過。

  • Our operation is actually -- and our company is operating as usual, including the work we do at the regional or central level and the various discussions with authorities.

    我們的運作實際上是——我們公司一切照常,包括我們在地區或中央層面開展的工作以及與當局進行的各種討論。

  • So we are really operating as business as usual.

    因此我們的業務實際上一切正常。

  • I mean China remains a very important country for us, both from the viewpoint of delivering medicines to the many patients who need our products, but also in terms of the innovation that can take place in that country.

    我的意思是,中國對我們來說仍然是一個非常重要的國家,不僅從向需要我們產品的眾多患者提供藥品的角度來看,而且從在該國可以進行的創新的角度來看。

  • And we haven't seen so far any sign that we are not operating as business as usual.

    到目前為止,我們還沒有看到任何跡象表明我們的業務沒有正常運作。

  • Having said that, as I said a bit earlier, it would be logical to assume some impact for at least a period of time, but it really is too early to say anything at this point in time.

    話雖如此,正如我之前所說,假設至少在一段時間內會產生一定影響是合乎邏輯的,但現在說什麼都為時過早。

  • We really don't have data to say anything.

    我們確實沒有數據可以說明什麼。

  • Ruud, do you want to comment on that?

    魯德,你想對此發表評論嗎?

  • Just to add -- sorry, I forgot to mention, and I should mention it is Ruud is actually, as you know, on an interim basis, managing the whole of international, including, of course, China, but also non-China.

    補充一下——抱歉,我忘了提了,我應該提一下,如你所知,魯德實際上在臨時管理整個國際事務,當然包括中國,但也包括中國以外的事務。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yeah.

    是的。

  • Thank you, Pascal.

    謝謝你,帕斯卡。

  • Coming back to China for one second, if you take the NRDL discussions as a proof point, so far, that is really going business as usual.

    回到中國的話題,如果以國家醫保目錄討論為證據點,那麼到目前為止,一切確實一切正常。

  • So once again, it's too far -- too early to speculate about any potential impact in the near future.

    因此,再說一次,現在推測近期的任何潛在影響還為時過早。

  • But so far, I think the teams are very, very dedicated in order to deliver a strong performance also moving forward.

    但到目前為止,我認為各隊都非常非常致力於在未來取得強勁的表現。

  • Having said that, very pleasing to see the growth in ex China that remains a very strong story for AstraZeneca and, of course, the people working in those parts.

    話雖如此,我們很高興看到中國以外的成長對於阿斯特捷利康以及在這些地區工作的員工來說仍然是一個非常強勁的成長。

  • The LATAM region specifically is doing extremely well, but also Middle East and Africa region is performing very well.

    拉丁美洲地區的表現尤其出色,中東和非洲地區的表現也十分出色。

  • And we have good hopes that, that will continue in the foreseeable future.

    我們充滿希望,這種情況在可預見的未來能夠持續下去。

  • The portfolio we are having in those markets is really fit for purpose in order to help those patients, whether it is in biopharma, oncology and more and more also in rare diseases.

    我們在這些市場中的產品組合確實能夠幫助這些患者,無論是在生物製藥、腫瘤學領域,還是在越來越多的罕見疾病領域。

  • So we continue to see strong growth in that.

    因此,我們繼續看到強勁成長。

  • And equally in 2025, we don't see big hiccups in those parts of the world.

    同樣,到 2025 年,我們也不會看到世界這些地區出現重大問題。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • I think it would be fair to say that every region with international is growing strongly.

    我認為可以公平地說,每個國際地區都在強勁成長。

  • I mean Latin America, strong growth.

    我指的是拉丁美洲,成長強勁。

  • Brazil, Mexico, in particular, strong growth in the Middle East, which is really a big opportunity in terms of growth potential.

    尤其是巴西、墨西哥和中東地區的強勁成長,從成長潛力來看,這確實是一個巨大的機會。

  • I was personally in South Asia recently.

    我最近親自去了南亞。

  • I mean the team is very excited.

    我的意思是整個團隊都非常興奮。

  • The growth rates there are pretty good.

    那裡的成長率相當好。

  • So across the whole of international regions, we are doing very, very well.

    因此,在整個國際地區,我們的表現都非常非常好。

  • Aradhana, do you want to talk about buybacks?

    Aradhana,你想談回購嗎?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Yeah, sure.

    是的,當然。

  • So you're absolutely right.

    所以你完全正確。

  • Generally, our view around buybacks has been we've done buybacks generally to offset the dilution from the share issuances, the employee stock issuances in the past.

    整體而言,我們對回購的看法是,我們通常會進行回購是為了抵銷過去股票發行、員工股票發行造成的稀釋。

  • I'll take a moment to remind you of our capital allocation priorities, which remain the same, which is, first and foremost, obviously, investing in the business.

    我要花點時間提醒您我們的資本配置優先事項保持不變,這顯然是首要的,即投資於業務。

  • That includes the CapEx, including staffs we have announced today, but really supporting the business from both a clinical and commercial standpoint.

    其中包括資本支出,包括我們今天宣布的員工,但真正從臨床和商業的角度支持業務。

  • Second is on business development.

    第二是業務發展。

  • You've seen us do very strategic and opportunistic business development, which is continuing to progress.

    您已經看到我們進行非常具有策略性和機會性的業務開發,並且正在不斷取得進展。

  • The third is to maintain a progressive dividend.

    三是保持累進紅利。

  • You saw that we increased our dividend this year.

    您看到我們今年增加了股息。

  • But given the circumstances now and what we believe is an overreaction in the market, we will consider and think about buybacks as well as part of our overall capital allocation priorities.

    但考慮到目前的情況以及我們認為的市場反應過度,我們將考慮並思考回購,並將其作為我們整體資本配置優先事項的一部分。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So the next question is Emmanuel Papadakis at Deutsche Bank.

    下一個問題是德意志銀行的 Emmanuel Papadakis。

  • Emmanuel Papadakis - Analyst

    Emmanuel Papadakis - Analyst

  • Perhaps a quick follow-up on AVANZAR if I may.

    如果可以的話,也許我可以快速跟進 AVANZAR。

  • Just to clarify, is all comers still the intent for the primary analysis?

    只是為了澄清一下,所有人仍然是主要分析的目的嗎?

  • And do you have agency alignment on that?

    你們在這方面有代理協議嗎?

  • And then maybe a question on the outlook for the respiratory franchise, very strong quarter for Symbicort and Breztri.

    然後也許有一個關於呼吸系統特許經營前景的問題,Symbicort 和 Breztri 本季表現非常強勁。

  • Maybe you could talk a little bit about the sustainability of the former Symbicort.

    也許您可以稍微談談前 Symbicort 的可持續性。

  • Can that continue to be a source of growth in 2025 and indeed beyond?

    這能否在 2025 年及以後繼續成為成長源?

  • And then Breztri, what about the potential to accelerate that in 2025 given only the IRA tailwind, but more importantly, the asthma readouts you have coming in the first half of the year?

    然後布雷茲特里,考慮到愛爾蘭共和軍的順風,以及更重要的是,今年上半年的氣喘讀數,2025 年加速這一進程的可能性有多大?

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

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

  • So AVANZAR is powered for both ITT and biomarker positive group, as we said.

    因此,正如我們所說,AVANZAR 對 ITT 和生物標記陽性組均有療效。

  • And I think they're well powered in both of those groups given the N of 1280 in that group.

    我認為他們在這兩個組中都具有很強的實力,因為該組中的 N 為 1280。

  • So we're confident about the confidence to see benefit in both groups.

    因此,我們有信心看到這兩組人都受益。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Okay.

    好的。

  • So thank you so much, Emmanuel, for the questions regarding the respiratory portfolio.

    非常感謝您,Emmanuel,回答有關呼吸問題的問題。

  • Indeed, a very strong growth.

    確實,成長非常強勁。

  • Equally, I'll say a few words about Symbicort and breast in a moment, but also the biologic portfolio is growing very fast as we speak. both Fasenra as well as Tezspire.

    同樣,我稍後會談一下 Symbicort 和乳房,但與此同時,生物製劑組合也在快速增長。 Fasenra 和 Tezspire。

  • Tezspire is on its way to become a $1 billion brand together with our colleagues of Amgen.

    Tezspire 正在與安進的同事一起努力成為價值 10 億美元的品牌。

  • Specifically regarding Symbicort, I think it's fair to say it's a great question, but difficult really to give a lot of guidance here in such a way that the mix of the different book of business is favorable as we speak.

    具體關於 Symbicort,我認為可以說這是一個很好的問題,但實際上很難在這裡給出很多指導,以便使我們所說的不同業務的組合有利。

  • And we don't know how that will evolve in the course of 2025.

    我們不知道到 2025 年這種情況將會如何發展。

  • We're following it.

    我們正在關注它。

  • It is also clear that our strategy in order to launch an authorized generic as well as lowering our list price, the WACC price in the United States is benefiting us clearly at the moment.

    很明顯,我們的策略是推出授權仿製藥並降低標價,美國的 WACC 價格目前明顯使我們受益。

  • But there are also uncertainties about the number of generics coming into the marketplace.

    但進入市場的仿製藥數量也存在不確定性。

  • So all in all, a very promising 2024, whether that will continue in 2025 needs to be seen.

    總而言之,2024 年前景非常光明,但這種前景是否會延續到 2025 年還有待觀察。

  • But of course, it also clearly indicates that Symbicort is really one of the cornerstone medicines for the treatment of asthma and COPD in the United States.

    但當然,這也清楚地表明 Symbicort 確實是美國治療氣喘和 COPD 的基石藥物之一。

  • The brand loyalty is extremely, extremely strong.

    品牌忠誠度極為強。

  • Breztri is clearly a different story.

    布雷茲特里的故事顯然有所不同。

  • It's still what we call in the early launch phases, very strong growth across the board, not only in the United States, but more and more in other parts of the world as well.

    目前仍處於我們所說的早期發布階段,全面強勁增長,不僅在美國,而且在世界其他地區也越來越明顯。

  • I think 2025 is a crucial year because we are expecting the readout of the pivotal COPD -- the asthma -- sorry, the asthma trial, the RESOLUTE, the trial for Breztri.

    我認為 2025 年是關鍵的一年,因為我們期待關鍵的 COPD——氣喘——氣喘試驗、RESOLUTE、Breztri 試驗的讀數。

  • So that's an important one as well.

    所以這也很重要。

  • And equally, we are putting a lot of resources behind the product in order to make that a multibillion-dollar opportunity.

    同樣,我們在該產品上投入了大量的資源,以使其成為一個價值數十億美元的商機。

  • And equally, of course, we're also looking forward to the Outcomes trial of Breztri moving forward in the cardiovascular space.

    當然,同樣,我們也期待 Breztri 在心血管領域的試驗成果會取得進展。

  • So that's -- I need to make one small point.

    所以那是——我需要強調一點。

  • It was not the RESOLUTE trial.

    這不是 RESOLUTE 審判。

  • The RESOLUTE trial is the Fasenra COPD trial.

    RESOLUTE 試驗是 Fasenra COPD 試驗。

  • It's the (inaudible) trial reading out, hopefully also next year, the Outcomes trial in asthma.

    這是(聽不清楚)試驗結果,希望明年也能進行氣喘試驗的結果。

  • So all in all, I think a very promising start, and we are looking forward to see even better results moving forward.

    總而言之,我認為這是一個非常有希望的開始,我們期待看到未來更好的結果。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • [Jo Walton, UBS].

    [瑞銀,Jo Walton]。

  • Jo Walton - Analyst

    Jo Walton - Analyst

  • My questions go back to topics we've already covered, I'm afraid.

    恐怕我的問題又回到了我們已經討論過的話題。

  • But just to follow up and make sure I understand this on Dato-DXd.

    但只是為了跟進並確保我理解 Dato-DXd 上的這一點。

  • You've clearly learned that there's more of a benefit in EGFR patients.

    您已經清楚地了解到 EGFR 患者可獲得更多益處。

  • But in AVANZAR, which is reporting next year, you've deliberately excluded AGA patients.

    但是在明年即將發布報告的 AVANZAR 中,您故意排除了 AGA 患者。

  • Does that increase the risk of the trial?

    這是否會增加審判的風險?

  • I appreciate you've altered the study design after TROPION-Lung01, but presumably, that doesn't impact the fact that you've excluded the AGA patients who are potentially the ones that this drug works best in?

    我很欣賞您在 TROPION-Lung01 之後改變了研究設計,但想必這不會影響您排除可能最適合該藥物的 AGA 患者這一事實?

  • So that's my first question.

    這是我的第一個問題。

  • And the second one is, I'm afraid to go back to China.

    第二個就是我害怕回中國。

  • I've had investor questions, those people who unfortunately weren't able to hear Aradhana give that very helpful call themselves.

    我曾接到投資者的提問,不幸的是,那些人自己沒能聽到 Aradhana 的那通非常有幫助的電話。

  • So the questions that we get are of the roughly 100 reps that you talk about that have been, in your view, potentially identified and charged, how many of those did you identify and get rid of for having discovered potential malpractice yourselves, which would show confidence in your internal compliance and how many of them were only found to have potentially done something after they had voluntarily left your employment?

    因此,我們收到的問題是,在你提到的大約 100 名可能被識別和指控的代表中,有多少人是你們自己發現潛在瀆職行為而識別並開除的,這表明你對內部合規性的信心,以及有多少人只是在自願離開您的工作後才被發現可能做了一些事情?

  • And has the current situation in China impacted any senior management plans to actually for people who are based outside of China to travel in China?

    中國目前的情況是否對高階主管讓在中國境外的人員來中國旅行的計畫產生了影響?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So Jo, we still have -- thank you for those two questions.

    所以喬,我們仍然——感謝您提出這兩個問題。

  • We still have a lot of questions waiting, and we have limited time.

    我們還有許多問題需要解決,而且我們的時間有限。

  • So for China, can I just refer everybody to the transcript?

    那麼對於中國來說,我可以讓大家來看看這份紀錄嗎?

  • I had a lot of good answers to those questions.

    我對這些問題有很多很好的答案。

  • Let me just say only that the point you raised about people being -- some people not being with the company actually highlights the difficulty we've had to identify the number of people because a lot of those people were not with the company anymore.

    我只想說,你提到的關於有些人已經不再是公司員工這一點,實際上凸顯了我們難以確定人數的困難,因為其中很多人已經不再是公司員工了。

  • So we don't have any precise data.

    所以我們沒有任何精確的數據。

  • We have data based on what we can put together based on what we know from employees, but also what the families could tell us of people who've left us.

    我們獲得的數據是基於從員工那裡了解到的情況,同時也包括家人告訴我們的關於離世員工的情況。

  • But in terms of the rest, I think the transcript will address your questions.

    但就其餘部分而言,我想記錄稿將解答您的問題。

  • And on the Dato question.

    還有關於拿督的問題。

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

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

  • Yeah.

    是的。

  • So thanks for the question.

    感謝您的提問。

  • So yeah, you're, of course, right that the first-line studies exclude the patients with actionable genomic alterations because the appropriate therapies for those patients are the therapies directed against those actionable genomic alterations.

    是的,您當然是對的,第一線研究排除了具有可操作基因變化的患者,因為適合這些患者的治療方法是針對這些可操作基因改變的治療方法。

  • But the TROPION-Lung02 and 04 studies that look at the combination of Dato with platinum-based chemotherapy and IO give you confidence about what you can potentially achieve in terms of the response rate, progression-free survival, and later outcomes.

    但是,TROPION-Lung02 和 04 研究關注的是 Dato 與鉑類化療和 IO 的結合,它讓您對在反應率、無進展生存期和後期結果方面可能取得的成果充滿信心。

  • And that's what that is built upon for the ITT population.

    這正是 ITT 人群所建立的基礎。

  • And as those data sets continue to mature, I think we continue to have confidence that we've got a good probability of success in the ITT population, particularly when focused on the non-squamous patient population, which is what we've done when we learned about the TROPION-Lung01 data set.

    隨著這些數據集不斷成熟,我認為我們仍然有信心在 ITT 人群中獲得成功的可能性很大,特別是當專注於非鱗狀患者人群時,這就是我們在我們了解了TROPION-Lung01數據集。

  • The opportunity to then also look in the biomarker positive, again, based on the effect size that we saw in that group in the TROPION-Lung01 is further confidence that you can build.

    然後,我們再次根據 TROPION-Lung01 中該組所見的效果大小,觀察生物標記是否呈陽性,這可以進一步增強我們的信心。

  • And as I've said, looking at internal data sets, we think that the biomarker that we identified in TROPION-Lung01 can also enrich for activity against those endpoints of both response rate and progression-free survival in the earlier line setting.

    正如我所說,透過查看內部數據集,我們認為 TROPION-Lung01 中發現的生物標記也可以增強早期治療中針對反應率和無進展生存期終點的活動。

  • So when you look at it as a totality, I think we've got the safety profile, the efficacy profile and the opportunity to enrich within those first-line studies, and that's what underpins the confidence in the AVANZAR study.

    因此,當你將其作為一個整體來看時,我認為我們已經獲得了安全性概況、有效性概況以及在那些一線研究中豐富的機會,這就是對 AVANZAR 研究的信心的基礎。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • I think, Jo if I could add two points on your question.

    我想,喬,我可以為你的問題補充兩點。

  • The first one, I think, is an important reminder is that in TROPION-Lung01, we didn't have a preplanned stats plan for non-squamous.

    第一個,我認為,重要的提醒是,在 TROPION-Lung01 中,我們沒有針對非鱗狀細胞癌制定預先計劃的統計計劃。

  • And I think that, that's an important part of how the data set was then being interpreted.

    我認為,這是資料集如何被解釋的一個重要部分。

  • But I think that had we shown the results that we did in a statistical analysis, those would have been statistically significant and clinically meaningful.

    但我認為,如果我們透過統計分析展示了我們的結果,那麼這些結果將具有統計意義和臨床意義。

  • And I think that we've applied the lessons from that into the front line.

    我認為我們已經把從中學到的教訓運用到前線了。

  • So I think that's an important piece.

    所以我認為這是很重要的一點。

  • And I think that your question on the AGA patients coming out, I mean it's a really different population when we're talking about EGFR TKI naive population.

    我認為您關於 AGA 患者的問題,我的意思是,當我們談論 EGFR TKI 初治人群時,這是一個非常不同的群體。

  • And so we are interested in that population, and that's TROPION-Lung 14, which is looking at Tagrisso plus Dato in addition to the other studies that are being looked at in the non-AGA population.

    因此,我們對該族群很感興趣,這就是 TROPION-Lung 14,該研究正在研究 Tagrisso 和 Dato 的組合以及在非 AGA 族群中正在研究的其他研究。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Two great points.

    兩個很好的觀點。

  • And maybe can I just add one more, which is really these combinations of Tagrisso and Dato, I think, will represent a great opportunity to defend Tagrisso and extend the treatment duration.

    也許我可以再補充一點,我認為 Tagrisso 和 Dato 的組合確實為捍衛 Tagrisso 和延長治療時間提供了絕佳的機會。

  • So not only they will be good for Dato, but they will be good for Tagrisso.

    因此,它們不僅對 Dato 有利,而且對 Tagrisso 也有利。

  • And we know that there is combination out there, but we will be the only company with -- or the only EGFR sub-generation with a combination with Dato.

    我們知道存在組合,但我們將是唯一與 Dato 結合的 EGFR 子代公司。

  • So that would be very material to the life cycle of Tagrisso as well.

    所以這對 Tagrisso 的生命週期也非常重要。

  • Mattias Häggblom at Handelsbanken.

    德國商業銀行 (Handelsbanken) 的 Mattias Häggblom。

  • Mattias Häggblom - Analyst

    Mattias Häggblom - Analyst

  • For the question one, please.

    請回答第一個問題。

  • On China, and I don't think it was covered on Aradhana's call.

    關於中國,我認為阿拉達納的電話中沒有涉及這個主題。

  • So on back of the medical insurance fraud case in 2021, it was clear that AstraZeneca tightened and changed its compliance system in China with more compliance officers and a new whistleblower system put in place.

    因此,在2021年醫療保險詐欺案的背後,很明顯阿斯特捷利康加強並改變了其在中國的合規體系,增加了合規官並建立了新的舉報人制度。

  • My question goes, what's been the main change in your view from then and today?

    我的問題是,從那時到現在,您的觀點有什麼主要的改變?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Yeah.

    是的。

  • If I got your question correctly, Matthias, I'm not 100% sure I do.

    馬蒂亞斯,如果我正確理解了你的問題,那麼我並不是 100% 確定我理解了。

  • Let me just make a few comments and then you can say whether I've not addressed your question.

    請允許我發表幾點評論,然後您可以說我是否沒有回答您的問題。

  • First of all, you need to understand that the series of cases that have unfolded over time, they have unfolded over time as a result of the investigation that we conducted, but also importantly, the authorities conducted, and it's important to remember, the authorities have access to a lot more data than we do because we cannot actually check people's personal web chat systems.

    首先,你需要了解,隨著時間的推移,一系列案件的發生,都是我們進行調查的結果,但同樣重要的是,當局進行的調查,重要的是要記住,當局因為我們無法真正檢查人們的個人網路聊天系統,所以他們可以獲得比我們多得多的數據。

  • We don't know what they do with the telephone, their personal telephones, et cetera, et cetera.

    我們不知道他們用電話、私人電話等等做什麼。

  • So a lot of this data has come about over time.

    大量的數據是隨著時間的推移而產生的。

  • And the cases refer back to this period of time that when we had reimbursement for T790M-mutation, but no reimbursement for Tagrisso.

    這些案例都與那段時期有關:T790M 突變的費用可以報銷,但 Tagrisso 的費用卻不能報銷。

  • And I think it's also important to keep in mind in the whole context is we had with this one and also with the illegal importation, we had a temporary situation. illegal importation really happened because Enhertu was not approved in China, and that is now gone because it's approved in China.

    我認為同樣重要的是要記住,在整個背景下,我們遇到的這個問題以及非法進口的情況都是暫時的。由於 Enhertu 未在中國獲得批准,非法進口確實存在,但現在這種情況已經消失,因為它已在中國獲得批准。

  • So hopefully, moving forward, those -- for the lack of a better word, temptations, if you want to -- that some of our reps in the field can have are gone.

    因此,希望,展望未來,我們的一些代表在現場可能遇到的那些——如果你願意的話,找不到更好的詞來形容——誘惑已經消失了。

  • So that's maybe one point.

    這也許是一個觀點。

  • In terms of -- yeah, so the testing opportunity ended in March 2021, just like the opportunity to import Enhertu from Hong Kong disappeared also early '24 when we launched in China.

    就——是的,測試機會在 2021 年 3 月結束,就像從香港進口 Enhertu 的機會也在 24 年初我們在中國推出時消失一樣。

  • So all those things are no longer there.

    所以所有那些東西都不再存在了。

  • So the environment is suddenly a lot more -- a lot simpler, if you want, right?

    因此,如果您願意的話,環境會突然變得更加簡單,對嗎?

  • In terms of the improvements we've made to our systems, we've really retrained everybody.

    就我們對系統所做的改進而言,我們確實對每個人都進行了重新培訓。

  • We have all sorts of measures in place to improve compliance.

    我們採取了各種措施來提高合規性。

  • But the most important ones, I believe, are the compliance changes we've implemented more recently that go beyond our systems because I think we have really top-notch systems to monitor our internal data.

    但我認為,最重要的是我們最近實施的超越我們系統的合規性變革,因為我認為我們擁有一流的系統來監控我們的內部數據。

  • So monitor expense reports, monitor internal e-mails.

    因此,監控費用報告,監控內部電子郵件。

  • And by the way, people now really are told to use our internal systems only and not their external, their own systems.

    順便說一句,現在確實告訴人們只使用我們的內部系統,而不是使用他們的外部系統,也就是他們自己的系統。

  • But we have lots of policies and systems in place to track expense report, use of credit cards, use of certified food suppliers, et cetera, et cetera.

    但是我們有很多政策和系統來追蹤費用報告、信用卡使用情況、認證食品供應商的使用情況等等。

  • Now we have to look at what's happening outside our system and two changes we've made that I think are important is we now have a number of compliance officers in the field.

    現在我們必須看看我們的系統之外發生了什麼,我認為我們做出了兩個重要的改變,那就是我們現在在現場擁有多位合規官。

  • Every region has a compliance officer because those people will be close to our salesforce and able to identify, hopefully, by talking to people on a daily basis, identify early anything that could happen that is not controlled by the policing of our systems.

    每個地區都有一名合規官,因為這些人與我們的銷售人員關係密切,並且能夠透過每天與人們交談,儘早發現可能發生的任何不受我們系統監管控制的事情。

  • The second thing we've done is we're going to be rotating the regional sales directors, so they don't stay too long in the same place because, of course if you stay in the same place, you can actually be impacted in your behavior.

    我們做的第二件事是,我們將輪換區域銷售總監,這樣他們就不會在同一個地方呆太久,因為,當然,如果你呆在同一個地方,你實際上可能會受到影響你的行為。

  • So those are -- I mean, we've made many other changes, but those are maybe the two most, I think, fundamental and they relate to people because you have systems and the systems you can track.

    所以這些是——我的意思是,我們已經做了許多其他改變,但我認為這些可能是最根本的兩個改變,它們與人有關,因為你有系統和你可以追蹤的系統。

  • Then you have people in what they do and that you have no way to track them unless you really are close to them in the field.

    然後你就會知道人們在做什麼,除非你在現場與他們關係密切,否則你無法追蹤他們。

  • So hopefully, I address your questions.

    因此希望我能解答您的問題。

  • And if not, maybe you can come back later.

    如果沒有的話,也許您可以稍後再回來。

  • And the next question is Eric Le Berrigaud at Stifel.

    下一個問題是來自 Stifel 的 Eric Le Berrigaud。

  • Eric Le Berrigaud - Analyst

    Eric Le Berrigaud - Analyst

  • First question relates to CapEx.

    第一個問題與資本支出有關。

  • Maybe a question for Aradhana.

    這可能是對 Aradhana 的一個問題。

  • You mentioned after nine months, $1.2 billion in CapEx this year, which would analyze around $1.8 billion.

    您提到九個月後,今年的資本支出為 12 億美元,分析結果顯示約 18 億美元。

  • And today, you're announcing a $3.5 billion CapEx investment in the US spread over two years, nonetheless, represent about doubling CapEx for each of the next two years if that's incremental.

    今天,你們宣布將在美國投資 35 億美元,分兩年投資,如果這是增量的話,那麼這意味著未來兩年每年的資本支出將增加一倍。

  • Maybe you can elaborate of how we should think about modeling CapEx into the second part of the decade.

    也許您可以詳細說明我們應該如何考慮將資本支出模型引入本世紀下半葉。

  • You were roughly between $1 billion and $1.5 billion a year.

    您每年的收入大約在 10 億到 15 億美元之間。

  • Now you're moving into roughly $2 billion.

    現在你的資金規模已經達到約 20 億美元。

  • Should we think about getting up to $3 billion or more every year into the second part of the decade?

    我們是否應該考慮在2020年下半年每年籌集30億美元或更多?

  • You also talked about increased CapEx on the weight loss management call.

    您還談到了減肥管理電話中資本支出的增加。

  • So just to put that into perspective.

    只是為了更好地理解這一點。

  • And a shorter question on Airsupra, maybe for Ruud.

    還有一個關於 Airsupra 的較短的問題,也許是針對 Ruud 的。

  • At the very end of last year, you made significant investment in commercial marketing to support the launch of Airsupra.

    去年年底,您在商業行銷方面做出大量投資以支持 Airsupra 的推出。

  • And you're now one year into the launch, you're pleased with how the drug is doing from a prescription and number of prescribers and et cetera, but it's not fully reflecting in numbers yet.

    現在距離該藥物的上市已經過去了一年,你對該藥物在處方、處方人數等方面的表現感到滿意,但這還沒有完全反映在數字上。

  • Are you still confident in reaching blockbuster status with this drug?

    您還有信心讓這款藥物達到暢銷藥的地位嗎?

  • And when should we expect an inflection point?

    我們什麼時候應該期待拐點的出現?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Great.

    偉大的。

  • Thank you.

    謝謝。

  • So I'll address the -- I think there were several subparts to your CapEx question.

    因此,我將解決這個問題——我認為您的資本支出問題有幾個子部分。

  • So first of all, CapEx for 2024, we always see in every year, a big spike in fourth quarter CapEx.

    首先,對於 2024 年的資本支出,我們每年都會看到第四季的資本支出大幅增加。

  • So I think that's still to be expected this year.

    所以我認為今年這仍然是可以預料到的。

  • But the guidance we had given for the full year was it would be a 50% increase over our CapEx in 2023, again, driven by several projects that I had listed.

    但我們給出的全年指導是,2023 年的資本支出將增加 50%,這同樣是由我列出的幾個項目所推動的。

  • Also, we had mentioned that these projects that we started are multiyear projects.

    我們也提到過,我們啟動的這些專案都是多年期專案。

  • So it's not like we start a facility this year and it's built and ready next year.

    因此,這並不意味著我們今年就開始建造一個工廠,然後明年它就可以建造並投入使用。

  • So these are multiyear investments, whether it's the cell therapy facility or the API facility in Ireland or the respiratory inhaled facility in Qingdao.

    因此,這些都是多年的投資,無論是愛爾蘭的細胞治療設施、 API 設施還是青島的呼吸吸入設施。

  • These are all multiyear, anywhere between three to five-year type projects that we've started.

    這些都是我們啟動的多年期項目,為期三至五年不等。

  • So that's one element and how you can think about on a going-forward basis.

    這是一個要素,也是您如何從長遠角度考慮的問題。

  • I think the second question was around how do we think about CapEx broadly speaking.

    我認為第二個問題是我們如何從廣義上看待資本支出。

  • And I'd say, as our portfolio expands, and you mentioned the GLP-1, we will again need to make the investments to support our portfolio.

    我想說,隨著我們的投資組合擴大,以及您提到的 GLP-1,我們將再次需要進行投資來支持我們的投資組合。

  • So the announcement today is also related to some of the investments we would need to make for clinical trial manufacturing.

    所以今天的公告也與我們需要為臨床試驗製造進行的一些投資有關。

  • But again, there's not only manufacturing investment, there are also R&D investments.

    但同樣,不僅有製造業投資,還有研發投資。

  • So in Kendall Square in Cambridge, we're building brand-new labs and bringing together all the researchers that we have in the Boston area and growing that footprint.

    因此,在劍橋的肯德爾廣場,我們正在建造一個全新的實驗室,並彙集波士頓地區的所有研究人員,並擴大我們的影響力。

  • So it's both investments in labs as well as in capital from a manufacturing standpoint.

    因此,從製造業的角度來看,這不僅是對實驗室的投資,也是對資本的投資。

  • And again, the portfolio success will drive some of that investment and many of the new technologies, as you know, require investment at risk.

    再次強調,投資組合的成功將推動部分投資,而且如你所知,許多新技術都需要有風險的投資。

  • So that's what we'll continue to do.

    所以我們會繼續這樣做。

  • And then I'll hand over to Ruud on Airsupra.

    然後我將把 Airsupra 的權力移交給魯德。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • So first of all, to answer your question about do we still believe it's a $1 billion-plus opportunity.

    首先,回答你的問題,我們是否仍然相信這是一個價值 10 億美元以上的機會。

  • The short answer is a clear yes.

    簡短的回答是肯定的。

  • I think also the recent BATURA data further emphasize the importance of these medicines for the treatment of asthma as a rescue medication.

    我還認為,最近的 BATURA 數據進一步強調了這些藥物作為急救藥物治療氣喘的重要性。

  • Secondly, yes, we are very pleased with the progress we are making with Airsupra, as I said in my prepared remarks, we have now more than 50,000 prescribers in the United States, more than 200,000 patients are on the drug.

    其次,是的,我們對 Airsupra 所取得的進展感到非常高興,正如我在準備好的演講中所說,現在我們在美國有超過 50,000 名處方人員,超過 200,000 名患者正在服用該藥物。

  • And this is all about getting more access.

    這一切都是為了獲得更多的存取權限。

  • At the moment, we have roughly 60% commercial access that will increase in the next few months.

    目前,我們的商業存取權限已達到約 60%,並且在接下來的幾個月內將會增加。

  • But more importantly, also from the January 1, we are expecting our first Part D access as well, and that will further boost the product.

    但更重要的是,從 1 月 1 日起,我們也期待第一個 D 部分存取權限,這將進一步推動產品的發展。

  • We're buying down very substantial amount of scripts as we speak, and that will diminish in the course of 2025.

    我們正在購買大量劇本,到 2025 年這一數量將會減少。

  • So my clear remark is stay tuned, but we are very committed and this product will move to $1 billion over the next few years.

    因此,我的明確意見是請繼續關注,但我們非常致力於此,該產品將在未來幾年內達到 10 億美元。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Ruud.

    謝謝你,魯德。

  • And by the way, we're also exploring opportunities outside of the US, which certainly gives further confidence in the product on a global basis.

    順便說一句,我們也在探索美國以外的機會,這無疑進一步增強了我們對全球產品的信心。

  • Next question is Rajesh Kumar at HSBC.

    下一個問題是匯豐銀行的 Rajesh Kumar。

  • Rajesh Kumar - Analyst

    Rajesh Kumar - Analyst

  • I will come to a question related to China, but not China itself.

    我將談一個與中國有關的問題,但不是中國本身。

  • I appreciate you don't know much about China and you have tightened a lot of compliance policy around there.

    我知道你們對中國了解不多,但你們卻在那裡加強了許多合規政策。

  • Should investors think about any other regions where you might have to tighten your compliance policies?

    投資人是否應該考慮在其他哪些地區可能需要收緊合規政策?

  • Or was there something peculiar about incentive structures in China that drove that behavior, which does not exist elsewhere?

    還是中國的激勵機制存在一些特殊之處,導致了這種行為,而這種行為在其他地方並不存在?

  • And the second one is on Dato.

    第二個是關於Dato的。

  • I appreciate you have a biomarker.

    我很欣賞你有生物標記。

  • Your confidence seems to have gone up.

    你的信心似乎增強了。

  • It's great to see a setback has not detracted you from trying out again.

    很高興看到挫折並沒有阻止你再次嘗試。

  • How can you give investors confidence that this time, this confidence is not misplaced, but is rooted in a lot more data or information that has informed decision to double up on Dato.

    你如何讓投資人相信,這一次,這種信心沒有錯位,而是植根於更多的數據或訊息,這些數據或資訊為加倍投資 Dato 做出了明智的決定。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Rajesh.

    謝謝你,拉傑什。

  • Let me cover the China question and Susan, you could cover the Dato question.

    讓我來談談中國問題,蘇珊,你可以談談拿督問題。

  • So yes, there was something peculiar in China, but it has nothing to do with the salesforce targets.

    是的,中國確實存在一些特殊情況,但這與銷售人員目標無關。

  • In fact, if you look at the last few years, last six years, China achieved its target overall, except during the COVID period.

    事實上,如果回顧過去幾年、過去六年,除了疫情期間,中國總體上都實現了目標。

  • But COVID, we knew that the reasons, everybody was wearing mask or we had lockdown, et cetera.

    但我們知道,由於新冠疫情,原因如下:每個人都戴著口罩,或者我們實行了封鎖,等等。

  • And the salesforce actually reached their bonus, their target bonus.

    銷售人員確實達到了他們的獎金,即目標獎金。

  • The peculiar thing -- and so the target in China were not especially stretched.

    奇怪的是──中國的目標並沒有特別擴大。

  • And then if you look at it, in fact, our biopharma business has no issue.

    如果你看一下,你會發現我們的生物製藥業務其實沒有問題。

  • So the peculiar thing is very simple.

    所以奇特的事情很簡單。

  • It is that, unfortunately, we had a period of time when there was a -- not a disconnect, but a difference in reimbursement.

    不幸的是,有一段時間,我們之間存在著──並不是脫節,而是報銷上的差異。

  • Tagrisso was only reimbursed for T790M.

    Tagrisso 僅獲得了 T790M 的報銷。

  • And as you can imagine, patients who were not positive and then wanted or could benefit from Tagrisso wanted it if they were EGFR mutants.

    你可以想像,如果患者檢測結果為陰性,並且希望從 Tagrisso 中獲益,那麼如果他們是 EGFR 突變體,他們就會想要使用 Tagrisso。

  • And that created an issue in terms of creating an incentive for people to try and misbehave on this front, unfortunately.

    不幸的是,這就產生了一個問題,即激勵人們試圖在這方面做出不當行為。

  • The other peculiar thing was launching new products in Hong Kong that were not yet approved in China Mainland.

    另一件奇怪的事情是在香港推出尚未在中國大陸批准的新產品。

  • Over the next period of time, this won't happen again because we're not launching new products in Hong Kong that will not be approved on the Mainland simply because we don't have new products to launch.

    在接下來的一段時間內,這種情況不會再發生,因為我們不會在香港推出在內地未獲批准的新產品,只是因為我們沒有新產品可推出。

  • In the future, we'll try to time align if we can, those two launches.

    將來,如果可以的話,我們會嘗試協調這兩次發布的時間。

  • And what is giving us hope is China's approval is happening much faster now than in the past.

    令我們充滿希望的是,中國現在的批准速度比過去快得多。

  • And if we cannot time align, we will certainly make sure we really follow supply very, very closely.

    如果我們不能同步時間,我們一定會確保非常密切地追蹤供應。

  • But this is what was peculiar is that a specific environment around a few products in oncology.

    但這是特殊的,因為腫瘤學中圍繞著少數產品形成了一個特定的環境。

  • I think that specific peculiar environment is no longer there, but suddenly, we are tightening our compliance outside our systems, as I explained.

    我認為特定的特殊環境已經不復存在,但正如我所解釋的那樣,我們突然開始加強系統之外的合規性。

  • Now we run a very large organization.

    現在我們經營著一個非常大的組織。

  • I don't have any reason to believe there are issues anywhere else.

    我沒有任何理由相信其他地方也存在問題。

  • But the whole industry has had issues in the US many years ago.

    但整個產業在美國多年前就已經出現了問題。

  • So you can never say we'll never have any issue.

    所以你不能說我們永遠不會有任何問題。

  • But today, we think we have a very good compliance system.

    但今天,我們認為我們有一個非常好的合規體系。

  • We have people who actually follow our code of ethics.

    我們有一些確實遵守我們的道德準則的員工。

  • Compliance is a priority everywhere.

    合規在任何地方都是首要任務。

  • I also want -- I mean, I don't want to underestimate the issue we've had.

    我還想——我的意思是,我不想低估我們面臨的問題。

  • And trust me, we take it very seriously.

    相信我,我們對此非常重視。

  • But I also want to make sure that we realize there's another -- I mean we have 12,000 people in Salesforce.

    但我也想確保我們意識到還有另一個——我的意思是我們在 Salesforce 有 12,000 名員工。

  • We have another 11,900 people in salesforce that are doing a good job in a compliant manner.

    我們還有另外 11,900 名銷售人員以合規的方式出色地完成工作。

  • And we should not throw all these people, all this team in the same bag as the 100 whom is behaved.

    我們不應該把所有這些人、這個團隊與那 100 個表現良好的人混為一談。

  • And then also, we have several thousand people outside the sales force that are also doing a good work every day.

    而且,除了銷售團隊之外,我們還有幾千人每天也在出色地工作。

  • So that's all I can say, but we, of course, will continue to manage compliance.

    這就是我能說的全部,但我們當然會繼續管理合規性。

  • We have more than 200 people in our global compliance team around the world.

    我們的全球合規團隊在世界各地有 200 多人。

  • And then we have local compliance people also that are connected and report to the global teams.

    我們也有本地合規人員與全球團隊保持聯繫並向其報告。

  • So this is certainly a big priority for us.

    所以這對我們來說無疑是個重中之重。

  • Susan, on Dato?

    蘇珊,在拿督嗎?

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

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

  • Yes, sure.

    是的,當然。

  • So one of the reasons why I enjoy my job so much is that I've constantly got the opportunity to learn.

    我如此熱愛我的工作的原因之一是我始終有學習的機會。

  • That's the nature of drug development and what we do.

    這就是藥物開發的本質以及我們所做的事情。

  • We're constantly learning.

    我們一直在學習。

  • And the reason why I'm more confident about Dato-DXd now is that we know more than we did at the time that we designed the TROPION-Lung01 study.

    我現在對 Dato-DXd 更有信心的原因是,我們比設計 TROPION-Lung01 研究時了解更多。

  • At that point, we didn't understand that there was going to be a difference in outcome between patients with non-squamous versus squamous cancer.

    那時,我們還不明白非鱗狀癌患者和鱗狀癌患者的治療結果會有什麼差異。

  • And we didn't have the biomarker data that we currently have now.

    我們還沒有目前擁有的生物標記數據。

  • We also didn't have as much data about the -- from the studies that I've mentioned a couple of times, the TROPION-Lung02 and 04 studies, which show the ability to combine safely with platinum, the increase in response rate that, that gives the ability to combine safely with the IO drugs.

    我們也沒有太多關於——從我多次提到的研究,TROPION-Lung02 和 04 研究中,這兩項研究顯示了與鉑類藥物安全結合的能力,以及反應率的提高,使其能夠安全地與IO藥物結合。

  • So we know much more now than we did at the time that the TROPION-Lung01 study was designed.

    因此,我們現在了解的比設計 TROPION-Lung01 研究時所了解的多得多。

  • And we're taking those learnings and embedding them into the first-line studies in non-small cell lung cancer, but also taking those principles and embedding them across the rest of the Dato program.

    我們將這些經驗應用到非小細胞肺癌的第一線研究中,同時也將這些原則應用到 Dato 計畫的其餘部分。

  • And I think the computational pathology technology is something that will help us optimize the benefit risk profile for our antibody drug conjugates across our portfolio.

    我認為計算病理學技術將有助於我們優化整個產品組合中抗體藥物偶聯物的效益風險狀況。

  • These are inherently targeted medicines.

    這些本質上都是有針對性的藥物。

  • They're targeted to the cell surface receptor.

    它們針對的是細胞表面受體。

  • In the case of TROP2, though, just immunohistochemistry alone doesn't give you all the information that you need about the patients that are most likely to benefit.

    然而,就 TROP2 而言,僅靠免疫組織化學技術並不能為您提供最有可能受益的患者所需的所有資訊。

  • And we've mentioned a few times that we need to look at the internalization rate as well.

    我們已經多次提到過,我們還需要考慮內部化率。

  • So we know a lot more, and that's what gives me confidence about the ability to maximize the potential of Dato-DXd, which I think has the potential to be a very important medicine.

    因此我們了解更多,這讓我對最大限度地發揮 Dato-DXd 的潛力充滿信心,我認為它有可能成為一種非常重要的藥物。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Susan.

    謝謝,蘇珊。

  • Maybe going back very quickly to the previous question.

    也許很快又回到之前的問題。

  • I said we have more than 200 people in the global compliance team around the world.

    我說我們全球合規團隊在世界各地有200多人。

  • In China itself, we have more than 200 people doing compliance-related work, either in the global compliance team or in finance functions, people doing really compliance work and checking on our internal systems on a regular basis.

    光是在中國,我們就有超過200人從事合規相關工作,無論是在全球合規團隊或財務職能部門,這些人真正從事合規工作並定期檢查我們的內部系統。

  • Gonzalo at Danske.

    丹麥銀行的 Gonzalo。

  • Gonzalo Castanon - Analyst

    Gonzalo Castanon - Analyst

  • Great.

    偉大的。

  • Just one on Dato-DXd filing.

    Dato-DXd 備案僅一份。

  • I'm not sure if I missed it, but could you clarify if you will also follow up after approval of this Dato initial indication outside the US based on current available data?

    我不確定我是否錯過了,但您能否根據目前可用的數據澄清一下,在美國以外批准該 Dato 初步適應症後,您是否也會進行跟進?

  • And if so, are you planning to file in the near term?

    如果是的話,您打算在近期內提出申請嗎?

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

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

  • Okay.

    好的。

  • So thanks for the question.

    感謝您的提問。

  • So we announced in the last quarter that we had submitted the European filing in particular.

    因此,我們在上個季度宣布我們已經提交了歐洲的申請。

  • That review and that regulatory review is ongoing.

    該審查和監管審查正在進行中。

  • So I don't have any more information to share with you at this point.

    因此目前我沒有更多資訊可以與你們分享。

  • Obviously, the background regulations in the US and other regions do differ in some regards.

    當然,美國與其他地區的背景規定在某些方面確實有所不同。

  • So we have to wait for the feedback from the regulatory authorities in other regions.

    所以我們還需等待其他地區監管機構的回饋。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Susan.

    謝謝,蘇珊。

  • For the last few questions, can I ask everybody to try and stick to one question.

    最後幾個問題,我能否請大家盡量集中回答一個問題。

  • And maybe I remember that we have more than one product, more than Dato in our portfolio.

    也許我記得我們的產品組合不只一種產品,不只 Dato 一個。

  • But over to you, Peter Welford from Jefferies.

    現在輪到你了,來自 Jefferies 的 Peter Welford。

  • Peter Welford - Analyst

    Peter Welford - Analyst

  • Very quick, two questions.

    很快,兩個問題。

  • One, just on I'm afraid it's China and Dato, but China, can you just confirm, is Leon still an employee of AstraZeneca at this moment in time?

    第一,恐怕是中國和拿督,但是中國,你能否確認,Leon 現在仍然是阿斯特捷利康的員工嗎?

  • And then secondly, on Dato, is there any plan to change at all the TL07 and TL08 trials because they're the ones with Keytruda to include a QCS biomarker analysis, the primary endpoint as has done with AVANZAR?

    其次,關於 Dato,是否有計劃改變所有 TL07 和 TL08 試驗,因為它們是與 Keytruda 一起進行的試驗,包括 QCS 生物標記分析,這是與 AVANZAR 一樣的主要終點?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So first question, in the interest of time, it's in the transcript.

    因此,第一個問題,出於時間考慮,它在記錄中。

  • So I would refer you to it.

    因此我建議你參考一下。

  • And second question, Susan?

    第二個問題,蘇珊?

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

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

  • So again, I would just say for TL08, which is in the PD-L1 high patient population, I think that's a different context in terms of the opportunity there.

    因此,我再說一遍,對於 TL08,它屬於 PD-L1 高患者群體,我認為就機會而言,這是一個不同的背景。

  • For TL07, the primary endpoint for that study is obviously in an intent-to-treat patient population.

    對於 TL07,研究的主要終點顯然是意圖治療患者群體。

  • So again, in contrast to AVANZAR, where we had designed the study with the opportunity to look in a biomarker-positive patient population, I think, is a little different for TROPION-Lung07.

    因此,與 AVANZAR 相比,我們在設計研究時考慮了生物標記陽性患者群體,但我認為 TROPION-Lung07 略有不同。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you.

    謝謝。

  • Next question.

    下一個問題。

  • I think we still have a couple of questions, Emily Field.

    我想我們還有幾個問題,艾蜜莉菲爾德。

  • Emily, go ahead.

    艾米麗,繼續說。

  • Emily, you may be on mute.

    艾米麗,你可能靜音了。

  • We can't hear you.

    我們聽不到你的聲音。

  • Okay.

    好的。

  • Could we try the next question?

    我們可以嘗試回答下一個問題嗎?

  • Sounds like

    聽起來像

  • [Luisa Hector]. Luisa over to you.

    [路易莎·赫克托]。路易莎交給你了。

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • So my question is linked to the FDA focus that we've seen for some time now on the subgroups looking for patients that really see the benefit.

    因此,我的問題與 FDA 的關注有關,我們已經看到一段時間以來,FDA 一直關注尋找真正受益的患者的亞群。

  • So could you remind us the rationale for running SERENA-4, which is in a smaller subgroup and then SERENA-6 and perhaps your levels of confidence ahead of those trials and how we should think about those two potential outcomes?

    那麼您能否提醒我們運行 SERENA-4 的理由(它在一個較小的子組中),然後是 SERENA-6,以及您對這些試驗的信心水平,以及我們應該如何看待這兩種潛在結果?

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

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

  • Thanks, Luisa.

    謝謝,路易莎。

  • Very happy to talk about Camizestrant, our next-generation SERD inhibitor.

    很高興能談論我們的下一代 SERD 抑制劑 Camizestrant。

  • And as you rightly point out, two important catalysts that are upcoming with -- it's SERENA-6 that's in the selected patient population, patient with ESR1 mutations.

    正如您正確指出的那樣,即將出現的兩個重要催化劑是 SERENA-6,它針對的是選定的患者群體,即患有 ESR1 突變的患者。

  • So this study is a novel trial design, which is guided by circulating tumor DNA detection of rising ESR1 mutation levels.

    因此本研究是一種新穎的試驗設計,以循環腫瘤 DNA 檢測上升的 ESR1 突變水平為指導。

  • Obviously, right at the beginning of patients' journey with ER-positive breast cancer, there's low levels of this mutation, but it tends to be clonally selected over time, particularly on aromatase inhibitors.

    顯然,在 ER 陽性乳癌患者剛開始患病時,這種突變的水平很低,但隨著時間的推移,它往往會被克隆選擇,特別是在芳香化酶抑制劑的作用下。

  • So the trial design is Camizestrant plus the CDK4/6 inhibitor versus continuation on the aromatase inhibitor and a CDK4/6 inhibitor.

    因此,試驗設計為 Camizestrant 加 CDK4/6 抑制劑與繼續使用芳香化酶抑制劑和 CDK4/6 抑制劑。

  • And I think given the data that's been seen with this class of drugs in ESR1 mutants, we've got a high probability of success here.

    我認為,鑑於該類藥物在 ESR1 突變體中觀察到的數據,我們成功的可能性很高。

  • It's also built off the had a one data set where we looked at fulvestrant, which isn't as potent a SERD inhibitor versus continuation on aromatase inhibitor in this setting.

    它也建立在我們研究了氟維司群的一組數據的基礎上,在這種情況下,氟維司群作為 SERD 抑制劑的效力不如繼續使用芳香酶抑制劑那麼強。

  • And again, that gives us confidence about that trial.

    這再次增強了我們對該試驗的信心。

  • However, the actual target for Camizestrant is the estrogen receptor.

    然而,Camizestrant 的真正目標是雌激素受體。

  • The original targeted therapies were hormonal therapies targeting the estrogen receptor.

    最初的標靶治療是針對雌激素受體的荷爾蒙療法。

  • So it's not just those patients with ESR1 mutations that are likely to benefit.

    因此,不僅僅是那些患有 ESR1 突變的患者可能受益。

  • It is the broader wild-type patient population that are endocrine sensitive that are likely to benefit.

    更廣泛的內分泌敏感的野生型患者群體可能會受益。

  • And again, we've previously seen that improving endocrine therapy can improve the outcomes.

    而且,我們之前已經看到,改善內分泌治療可以改善療效。

  • And that's really the -- across in a range of both adjuvant as well as first-line, in particular, metastatic ER-positive breast cancer.

    這實際上是跨一系列輔助治療和一線治療,特別是轉移性 ER 陽性乳癌。

  • So I think the data that we've seen from the SERENA-2 data set, which was a randomized study in the second line, if you look at the subgroup that was endocrine sensitive with that group, we also saw a very positive hazard ratio compared with fulvestrant, which was the previous best SERD that was available.

    因此,我認為我們從 SERENA-2 數據集(這是第二線的一項隨機研究)中看到的數據,如果您查看該組中對內分泌敏感的亞組,我們也看到了非常正的風險比與之前最好的SERD——氟維司群相比。

  • So I think both the SERENA-2 data and then the SERENA-3 data in the window opportunity study give us confidence that we've got a really best-in-class profile here from a safety and efficacy perspective that gives us good probability of both those studies being positive, and that would be a big combination of indications.

    因此,我認為窗口機會研究中的SERENA-2 數據和SERENA-3 數據都讓我們有信心,從安全性和有效性的角度來看,我們已經獲得了一流的數據,這讓我們有很大的可能性這兩項研究的結果都是正面的,這將是一個很大的跡象。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • So one last question, Emily Field at Barclays.

    最後一個問題,巴克萊銀行的艾米莉·菲爾德。

  • Emily Field - Analyst

    Emily Field - Analyst

  • Thank you so much for getting to me.

    非常感謝您來到我這裡。

  • I really appreciate it.

    我非常感激。

  • And hopefully, this is a good fun one to end on.

    希望這是一個愉快而美好的結局。

  • So I know you said earlier in the year that by the end of 2025, we'll have a good idea of the achievability of the 2030 [$80 billion] revenue target.

    所以我知道您今年稍早說過,到 2025 年底,我們將對實現 2030 年 [800 億美元] 收入目標有一個很好的了解。

  • And you have so many catalysts coming up next year.

    明年會出現很多催化劑。

  • What would you consider to be the most important ones in determining the achievability of that target?

    您認為決定該目標能否達成的最重要因素是什麼?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Dave, do you want to get started for oncology?

    戴夫,你想開始研究腫瘤學嗎?

  • Great question, Emily, by the way.

    順便說一句,艾米麗,這個問題問得很好。

  • But a long answer, I suppose, yeah.

    但我想,答案會很長,是的。

  • But go ahead, Dave.

    但繼續吧,戴夫。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • It'd be my pleasure.

    我非常榮幸。

  • I think just as we kind of go through and do a little bit of roll call here, I think in hand already, Emily, really importantly, we've got AMPLIFY, which is very important for Calquence opportunity to really establish both a finite and a treat-to-progression leadership opportunity with Calquence and I think that this is going to be an important part of that medicine going forward.

    我認為,就像我們在這裡進行一些點名一樣,我認為已經在手頭上了,艾米麗,非常重要的是,我們已經有了AMPLIFY,這對Calquence來說非常重要,可以真正建立一個有限和與Calquence 合作的從治療到進展的領導機會,我認為這將成為該醫學未來發展的重要組成部分。

  • Luisa's question just teed up another really important piece.

    路易莎的問題恰好引出了另一個非常重要的問題。

  • I think that SERENA-6 and then following SERENA-4, that's a major readout in 2025.

    我認為 SERENA-6 以及隨後的 SERENA-4 將會在 2025 年產生重大讀數。

  • I think that certainly, those studies give a read-through into the CAMBRIA studies as well.

    我認為這些研究當然也對 CAMBRIA 研究進行了解讀。

  • So in terms of longer-term unwind of risk.

    就長期風險解除而言。

  • And then I would really then just highlight if I was to pick one other additional one on here, Enhertu moving into earlier lines with DB09, we know based on what we saw with the 03 study and how it compares to the frontline studies that we had seen before that there's a really great opportunity to move in the front line.

    然後,我真的想強調一下,如果我要在這裡選擇另一個,Enhertu 將與 DB09 一起進入早期產品線,我們根據 03 年研究的結果以及它與我們進行的前沿研究的比較知道我之前就看到過,這是一個挺進前線的好機會。

  • The trial design allows for with and without PERJETA.

    試驗設計允許使用或不使用 PERJETA。

  • And I think that this represents another very important growth opportunity in the near term.

    我認為這代表著近期另一個非常重要的成長機會。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yeah.

    是的。

  • First of all, I think baxdrostat, I think it's a great opportunity if the study is positive in a very difficult-to-treat hypertensive population.

    首先,我認為baxdrostat,如果這項研究對極難治療的高血壓族群產生了積極影響,那麼這是一個很好的機會。

  • Clearly, also our entry potentially of Breztri, which I mentioned in the asthma indication.

    顯然,我們也有可能引入 Breztri,我在氣喘適應症中提到過它。

  • And last but not least, Fasenra in the COPD indication, so all of them are very large, either new molecules or new indications, so very exciting to move into 2025.

    最後但並非最不重要的是,Fasenra 用於治療 COPD 適應症,因此它們都非常大,無論是新分子還是新適應症,因此進入 2025 年非常令人興奮。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • And last but not least, Marc, for rare disease.

    最後但同樣重要的是,馬克 (Marc),致力於罕見疾病研究。

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

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

  • I mean my expectation is we presently have 10 ongoing Phase 3 on different molecules for complement.

    我的預期是,我們目前有 10 個針對不同補體分子的 3 期臨床試驗正在進行中。

  • And most of them are going to read out in 2025.

    其中大部分將於2025年宣讀。

  • So I would expect that we beat the statistical average of the Phase 3 clinical trials and demonstrate that these products are safe and active.

    因此我希望我們能夠超越第三階段臨床試驗的統計平均值,並證明這些產品是安全且有效的。

  • So this is going to be a very interesting period for rare disease in 2025.

    因此,2025 年對於罕見疾病來說將是一個非常有趣的時期。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc.

    謝謝你,馬克。

  • Beyond C5, we also have Eneboparatide that we'll read out next year, which is clearly an important product for rare disease, but also for the company overall.

    除了 C5 之外,我們還有將於明年推出的 Eneboparatide,這顯然是治療罕見疾病的重要產品,而且對整個公司也同樣重要。

  • So thank you very much for all your great questions and your interest.

    非常感謝您提出的所有精彩問題和關注。

  • Let me just quickly conclude.

    讓我快速地總結一下。

  • First of all, I want to say regarding the matters in China, we are really taking this matter seriously.

    首先我想說,關於中國的事情,我們非常重視這個問題。

  • I mean, I've said it a few times today, but I want to say it again.

    我的意思是,我今天已經說過幾次了,但我還想再說一次。

  • I also want to say the investigations are directed at individuals as we understand it now.

    我還想說,據我們現在了解,調查是針對個人的。

  • So we haven't been really given access to many details.

    因此我們實際上尚未獲得太多詳細資訊。

  • In fact, we have very limited information, which explains why we give you the answers we give you.

    事實上,我們掌握的資訊非常有限,這也解釋了為什麼我們會給你這樣的答案。

  • Aradhana gave a great call last week, and you have the transcript that will give you more information if you are interested.

    阿拉達納 (Aradhana) 上週打了一次很棒的電話,如果您有興趣的話,您可以查閱電話記錄,其中會提供更多資訊。

  • Again, the fact is we are trying to be as transparent as we can, but we have very limited information.

    再次強調,事實上我們正在努力做到盡可能透明,但我們掌握的資訊非常有限。

  • And last point is we are really strengthening our compliance to make sure that we learn from this issue, we learn from this situation, and then continue to improve and become even stronger in China, but anywhere in the world.

    最後一點是,我們正在切實加強合規工作,以確保我們從這個問題、從這種情況中汲取教訓,然後繼續改進,在中國乃至世界任何地方都變得更加強大。

  • Second quick closing comment is we had tremendous results in Q3 and in nine months.

    第二個簡短的結論是我們在第三季和前九個月取得了巨大的成果。

  • So we're very excited with the actually momentum we have to the extent that we are doing better than we expected actually, and we've been able to increase to raise our guidance for the year.

    因此,我們對實際的發展勢頭感到非常興奮,實際上我們的表現比預期的要好,而且我們已經能夠提高今年的業績指引。

  • And I think it's important to think about that kind of momentum.

    我認為考慮這種勢頭很重要。

  • I mean, we have a company that is on an annual basis, around $50 billion now growing at 19%, 20%.

    我的意思是,我們公司每年的營業額大約是 500 億美元,現在的成長率為 19% 到 20%。

  • So this is the kind of momentum we are taking into 2025 with headwinds for sure, but also new indications to launch, new products that are approved.

    因此,這就是我們進入 2025 年時所面臨的勢頭,儘管肯定會面臨阻力,但也會推出新的適應症,推出新的產品,並獲得批准。

  • And we also will continue working on leverage.

    我們也將繼續致力於發揮槓桿作用。

  • So when you take all of this together, you can see why we are confident in the outlook both from a revenue, but also an EPS viewpoint.

    因此,當你把所有這些因素綜合起來時,你就會明白為什麼我們對收入和每股盈餘的前景充滿信心。

  • And we are on track to achieve our long-term strategic ambitions.

    我們正在實現我們的長期策略目標。

  • As we said before, not everything is going to go perfectly.

    正如我們之前所說,並不是所有事情都會順利進行。

  • Of course, this is not an easy business we're in, and we will have, of course, issues, setbacks in our pipeline, but also we expect to deliver a lot of new news and new products, new indications.

    當然,我們所從事的業務並不輕鬆,我們在研發過程中當然會遇到問題和挫折,但我們也期望發布大量新消息、新產品和新適應症。

  • So there's really every reason to believe we are on track and can deliver on our long-term strategic ambitions.

    因此,我們完全有理由相信,我們正在朝著正確的方向前進,並能夠實現我們的長期策略目標。

  • So with this, thank you again, and I wish you a good rest of the day.

    因此,我再次感謝您,並祝您今天剩餘的時間過得愉快。