AstraZeneca PLC (AZN) 2025 Q2 法說會逐字稿

內容摘要

  1. 摘要
    • Q2 2025 營收年增 11%,核心 EPS 年增 17%,主要受創新藥品需求帶動,產品銷售成長 10%,聯盟收入成長 38%。
    • 公司重申 2025 年指引:全年營收高個位數百分比成長,EPS 低雙位數百分比成長,未調整指引。
    • 市場反應未於逐字稿中明確揭露。
  2. 成長動能 & 風險
    • 成長動能:
      • 創新藥品需求強勁,尤其在腫瘤學與生物製藥領域皆為雙位數成長。
      • 2025 年上半年已獲得 19 項重要地區的法規核准,12 項正向 Phase III 臨床試驗結果,5 個新分子實體取得關鍵數據。
      • 腫瘤學產品線(如Tagrisso、Enhertu、Imfinzi)多項新適應症推進,帶動營收與市占提升。
      • 生物製藥(R&I、CVRM)與罕見疾病事業群均有新藥推進與正向臨床數據(如baxdrostat、Tezspire、Fasenra、Ultomiris)。
      • 積極投資於轉型性技術(如IO雙特異性抗體、ADC、細胞治療),為 2030 年後成長奠定基礎。
    • 風險:
      • Medicare Part D 改革、Soliris 生物相似藥競爭、BRILINTA 專利到期等因素將壓抑下半年毛利率與部分產品營收。
      • 中國市場 Pulmicort 仿製藥與 Forxiga VBP(帶量採購)政策將影響區域成長與價格。
      • 部分新藥(如anselamimab)臨床試驗未達主要終點,需進一步分析細分族群效益。
      • 罕見疾病與新適應症市場競爭加劇,需持續推動產品差異化與市場滲透。
  3. 核心 KPI / 事業群
    • 腫瘤學事業群:上半年營收年增 16% 至 120 億美元,美國成長 19%,主要產品(Tagrisso、Calquence、Lynparza、Truqap、Imfinzi、Enhertu)皆為雙位數成長。
    • 生物製藥事業群:上半年營收年增 10% 至 112 億美元,R&I 年增 13%,CVRM 年增 8%。Fasenra Q2 年增 18%,Tezspire Q2 年增 65%,Breztri Q2 年增 20%。Farxiga Q2 年增 10%,Lokelma Q2 年增 27%。
    • 罕見疾病事業群:Q2 營收年增 7%,上半年年增 3% 至 43 億美元。Ultomiris Q2 年增 23%,Soliris 持續下滑,Strensiq 與 Koselugo Q2 分別年增 15% 與 18%。
    • 核心毛利率:上半年 83%,全年預期下滑 60-70 個基點。
    • R&D 費用:上半年年增 17%,佔營收 23%,全年預期落在營收低 20% 區間高端。
    • SG&A 費用:上半年年增 3%,低於營收增速,反映營運槓桿提升。
  4. 財務預測
    • 2025 年營收預期高個位數百分比成長,EPS 低雙位數百分比成長(重申指引)。
    • 全年核心毛利率預期較去年下滑 60-70 個基點,受 Medicare Part D、Soliris 生物相似藥、合作產品分潤等影響。
    • 2025 年 CapEx 預計年增 50%,上半年已支出 13 億美元,去年全年為 22 億美元。
  5. 法人 Q&A
    • Q: Datroway/AVANZAR 對 2030 年 800 億美元營收目標的重要性?對非腫瘤新藥(如baxdrostat、IL-33、anselamimab)信心如何?VEGF 雙特異性抗體策略?
      A: 800 億美元目標不依賴 AVANZAR 單一試驗,為全產品線風險調整後預估,近期多項新藥已去風險化。VEGF 機制在多適應症有潛力,rilvegostomig 雙特異性抗體具組合優勢,重點在於與 ADC 等多元組合。
    • Q: Imfinzi 在膀胱癌、胃癌的市場機會與競爭?Enhertu 在 HER2+ 乳癌一線的定位與用法?
      A: Imfinzi 在膀胱癌(NIAGARA、POTOMAC)與胃癌(MATTERHORN)皆為潛在重磅機會,已見強勁初期滲透,未來將靠多適應症推進。Enhertu 預期將依 DB-09 臨床設計用於一線治療,治療至疾病進展,完整數據支持臨床行為。
    • Q: tozorakimab(IL-33 單抗)在 COPD 的差異化與競爭對手近期失利後的信心?anselamimab 亞組分析與 FDA 審查可能性?
      A: tozorakimab 可同時抑制 ST2 與 RAGE/EGFR 路徑,具差異化潛力,Phase II 已見正向訊號,期待明年 LUNAR 計畫讀取。anselamimab 在特定亞組有明顯臨床效益,該族群為可觀少數,將與主管機關討論審查路徑。
    • Q: Enhertu 未來營收上看 100 億美元的成長路徑?AZ 在肥胖/代謝症候群市場的策略與競爭優勢?
      A: Enhertu 各區域皆見強勁成長,DB-09 一線、DB-11/05 早期乳癌、組合療法等多重成長動能,預期可達重磅藥水準。肥胖/代謝領域將以口服 GLP-1、PCSK9 及多機制組合切入,聚焦中央肥胖與多重代謝風險,強調可及性與全球市場滲透。
    • Q: Soliris 生物相似藥上市後,Ultomiris 市場動態?Forxiga 在中國 VBP 政策下的影響與應對?
      A: Ultomiris 持續取代 Soliris,未見 payer 強制回流生物相似藥,轉換後 Ultomiris 成長穩健。Forxiga VBP 將帶來短期價格下滑,但預期用量擴大、消費者自費購藥(consumerization)可帶來長尾效應,參考過去品牌經驗。

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 afternoon and welcome to AstraZeneca's H1 and Q2 2025 webinar for investors and analysts. Before I hand over to AstraZeneca, I'd like to read the Safe Harbor Statement. The company intends to utilize the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca.

    下午好,歡迎參加阿斯特捷利康針對投資者和分析師的 2025 年上半年和第二季度網路研討會。在交給阿斯特捷利康之前,我想先讀安全港聲明。該公司打算利用 1995 年美國私人證券訴訟改革法案的安全港條款。本次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. Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call.

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

  • The company undertakes no obligation to update forward-looking statements. Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation and webcast. There will be an opportunity to ask questions after today's presentations. Please use the raise a hand feature to indicate you wish to ask a question at any time during the call.

    該公司不承擔更新前瞻性陳述的義務。也請仔細閱讀本簡報和網路廣播附帶的幻燈片中的前瞻性聲明免責聲明。今天的演講結束後將有機會提問。請在通話期間隨時使用舉手功能來表示您希望提問。

  • And with that, I'd now like to hand the conference over to the Head of Investor Relations at AstraZeneca, Andy Barnett.

    現在,我想將會議交給阿斯特捷利康投資者關係主管安迪巴內特 (Andy Barnett)。

  • Andy Barnett - Head of Investor Relations

    Andy Barnett - Head of Investor Relations

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

    熱烈歡迎大家參加阿斯特捷利康針對投資者和分析師的 2025 年上半年和第二季度演示電話會議和網路直播。我是投資者關係主管安迪巴內特 (Andy Barnett)。在將工作交給帕斯卡和其他執行團隊成員之前,我想先談談一些重要的日常事務。

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

    首先,今天提供的所有資料都可以在我們的阿斯特捷利康投資者關係網站上找到。這張投影片包含我們的安全港聲明,我鼓勵您花時間閱讀。我們將使用固定匯率或 CER、核心財務數據和其他非 GAAP 指標對我們的業績做出評論。業績公告中包含非公認會計準則與公認會計準則的對帳表,除非另有說明,所有引用的數字均以百萬美元為單位。

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

    這張投影片展示了我們今天電話會議的議程。準備好的發言結束後,我們將開放提問專線。像往常一樣,我們會嘗試在規定時間內解答盡可能多的問題,但請限制提問的數量,以便其他人有公平的機會參與問答。

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

    說完這些,我會把電話交給帕斯卡。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Andy, and welcome, everyone. I'm pleased to report that our strong growth momentum and excellent pipeline delivery continued through the first half of 2025. In the first six months of the year, total revenue grew by 11%, driven by continued demand for innovative medicines. Core EPS grew 17%, reflecting the importance we place upon investing in our pipeline while driving operating leverage across our company.

    謝謝你,安迪,歡迎大家。我很高興地報告,我們強勁的成長勢頭和出色的管道交付將持續到 2025 年上半年。今年上半年,受創新藥物持續需求的推動,總收入成長了11%。核心每股收益成長了 17%,這反映了我們對投資管道的重視,同時推動了整個公司的營運槓桿。

  • Since our full year results in February, we have achieved 19 regulatory approvals in key regions, and the pace at which we are bringing new medicines to patients around the world continues to accelerate. In the year to date, our pipeline delivery has been excellent. We have already announced the results of 12 positive Phase III trials this year, including the first pivotal data for five new molecular entities. In the past few weeks alone, we communicated the high-level results for baxdrostat and gefurulimab, which both represent important potential contributors to our 2030 ambition.

    自二月公佈全年業績以來,我們已在重點地區獲得19項監管批准,為全球患者帶來新藥的步伐不斷加快。今年迄今為止,我們的管道交付表現非常出色。今年我們已經公佈了12項積極的III期試驗結果,其中包含5個新分子實體的首批關鍵數據。僅在過去幾週,我們就發布了巴曲司他和吉芙露利單抗的高水準結果,這兩項研究都代表著我們實現 2030 年目標的重要潛在貢獻者。

  • Please move to the next slide. Our diverse, broad-based business continues to present an attractive risk profile, resilient to regional disruption. And I'm pleased to report once again that we saw strong growth across therapy areas and geographies. In the first half, we saw double-digit growth across oncology and biopharmaceuticals, and a return to growth for our rare disease business in the second quarter, which was up 7%.

    請移至下一張投影片。我們多元化、基礎廣泛的業務持續呈現具有吸引力的風控狀況,並能抵禦區域性波動。我很高興再次報告,我們在各個治療領域和地區都看到了強勁的成長。上半年,我們的腫瘤學和生物製藥業務實現了兩位數成長,第二季度我們的罕見疾病業務恢復成長,成長了 7%。

  • We also saw robust growth across geographies, particularly in the US and the emerging markets outside of China. And the line demand also remained strong across other regions, including in China, where the growth rate continues to be affected by Pulmicort generics.

    我們也看到各個地區的強勁成長,尤其是美國和中國以外的新興市場。其他地區的線路需求也依然強勁,包括中國,但其成長率持續受到 Pulmicort 仿製藥的影響。

  • Next slide, please. We continue to progress through a catalyst-rich period, and we've already announced multiple high-value trials, with many more to come throughout the remainder of the year and into 2026. In oncology, we continue to grow our leading position in breast cancer, reinforced by positive trial results for camizestrant in SERENA-6 and Enhertu in DESTINY-Breast09 and DESTINY-Breast11 trials.

    請看下一張投影片。我們將繼續在催化劑豐富的時期取得進展,並且已經宣布了多項高價值試驗,並且在今年剩餘時間和 2026 年還將進行更多試驗。在腫瘤學領域,我們繼續鞏固在乳癌領域的領先地位,SERENA-6 試驗中卡米司群以及 DESTINY-Breast09 和 DESTINY-Breast11 試驗中 Enhertu 的積極試驗結果進一步鞏固了這一地位。

  • We are also expanding our presence in gastrointestinal and bladder cancers with the MATTERHORN and POTOMAC trials of Imfinzi. In addition, we saw positive overall survival data from FLAURA2 for Tagrisso plus chemotherapy, consolidating our leading position in EGFR-mutated lung cancer. In biopharmaceuticals, the KALOS/LOGOS program has the potential to bring Breztri into uncontrolled asthma, and the BaxHTN trial for baxdrostat represents an exciting opportunity to redefine treatment for patients with hard-to-treat hypertension.

    我們也透過 Imfinzi 的 MATTERHORN 和 POTOMAC 試驗擴大我們在胃腸道癌和膀胱癌領域的影響力。此外,我們在 FLAURA2 中看到了 Tagrisso 聯合化療的積極整體存活數據,鞏固了我們在 EGFR 突變肺癌領域的領先地位。在生物製藥領域,KALOS/LOGOS 計畫有可能將 Breztri 引入不受控制的氣喘治療領域,而針對巴曲司他的 BaxHTN 試驗則代表著一個令人興奮的機會,可以重新定義難治性高血壓患者的治療方法。

  • Finally, our rare disease pipeline is making excellent progress. We recently announced readouts for the CARES program of anselamimab in severe light chain amyloidosis and a prevailed trial for gefurulimab in GMG. Including the trials highlighted here, the Phase III readouts in 2025 have the combined potential to generate well over $10 billion in peak year revenue on a risk-adjusted basis. And this is why I've said many times in the past, by the end of this year, early next year, you will have a very good sense of the direction in terms of our $80 billion target for 2030, which we believe we are on track to achieve at this stage.

    最後,我們的罕見疾病研發管線正在取得良好進展。我們最近公佈了安塞拉米單抗治療嚴重輕鏈澱粉樣變性的 CARES 計劃的讀數,以及吉夫魯利單抗治療 GMG 的成功試驗。包括這裡重點介紹的試驗在內,2025 年的第三階段讀數在風險調整後具有產生超過 100 億美元的峰值年收入的潛力。這就是為什麼我過去多次說過,到今年年底或明年年初,你們將對我們 2030 年 800 億美元的目標有很好的方向感,我們相信我們目前正朝著實現這一目標的方向前進。

  • Next slide, please. We continue to make exciting progress with our transformative technologies, which have the potential to drive our growth well beyond 2030. At ASCO this year, we shared the first combination data for our IO bispecifics rilvegostomig in combination with (inaudible), as we seek to displace both first-generation IO checkpoint inhibitors, as well as traditional chemotherapy.

    請看下一張投影片。我們的變革性技術不斷取得令人振奮的進展,這些技術有可能推動我們在 2030 年後的成長。在今年的 ASCO 上,我們分享了我們的 IO 雙特異性藥物 rilvegostomig 與(聽不清楚)聯合使用的首個聯合數據,因為我們尋求取代第一代 IO 檢查點抑制劑以及傳統化療。

  • Since ASCO, we've moved yet another ADC using our proprietary platform into the clinic, furthering our ambition to replace chemotherapy across a broad range of cancer types.

    自 ASCO 以來,我們已使用專有平台將另一種 ADC 引入臨床,進一步實現了我們在多種癌症類型中取代化療的雄心。

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

    接下來,請進入下一張投影片,我將把時間交給 Aradhana。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

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

    謝謝你,帕斯卡,大家早安,下午好。像往常一樣,我將從報告損益表開始。

  • Next slide, please. As Pascal highlighted, total revenue increased by 11% in the first half. Product sales increased by 10%, with sustained strong momentum across key brands, and alliance revenue was up 38%, driven by growth in shared profits of Enhertu, Tezspire, and Beyfortus in regions where our partners book product sales.

    請看下一張投影片。正如帕斯卡所強調的,上半年總收入成長了 11%。產品銷售額成長了 10%,主要品牌保持了強勁勢頭,聯盟收入成長了 38%,這得益於我們合作夥伴預訂產品銷售的地區的 Enhertu、Tezspire 和 Beyfortus 的共享利潤成長。

  • Next slide, please. Turning to our core P&L, we saw a total revenue gross margin of 83% in the first half, benefiting from product sales mix and favorable FX impact in the first quarter, with somewhat reverse in the second quarter. As previously stated, we anticipate that the total revenue core gross margin will decline by around 60 basis points to 70 basis points in 2025, driven by factors such as Medicare Part D redesign, Soliris biosimilar competition, and increased profit share related to partnered products.

    請看下一張投影片。談到我們的核心損益表,我們看到上半年總收入毛利率為 83%,受益於第一季的產品銷售組合和有利的外匯影響,而第二季度則有所逆轉。如前所述,我們預計,受醫療保險 D 部分重新設計、Soliris 生物相似藥競爭以及與合作產品相關的利潤份額增加等因素的影響,2025 年總收入核心毛利率將下降約 60 個基點至 70 個基點。

  • We anticipate a gross margin in the second half of the year driven by these factors, as well as the usual seasonal pattern for medicines such as FluMist. Total operating expenses increased by 9% in the first half, below top-line growth of 11%. Poor R&D costs increased by 17% and represented 23% of total revenue, driven by accelerated recruitment into our clinical trials, the additional costs relating to medicines acquired through business development, and a step-up of investments in transformative technologies.

    我們預計下半年的毛利率將受這些因素以及 FluMist 等藥品的常見季節性模式的影響。上半年總營運費用增加了 9%,低於 11% 的營收增幅。不良研發成本增加了 17%,佔總收入的 23%,這得益於我們臨床試驗的招募速度加快、透過業務開發獲得的藥物相關的額外成本以及對變革性技術的投資增加。

  • As mentioned at our ASCO event in June, we now anticipate core R&D costs for the full year to land at the upper end of the low 20s percentage range of total revenue. Core SG&A costs increased by 3%, growing at a much smaller rate than total revenue. We are anticipating continued operating leverage and margin improvement this year. Similar to prior years, we expect a lower margin in the second half, primarily relating to the growth margin effects previously mentioned.

    正如我們在 6 月的 ASCO 活動上所提到的那樣,我們現在預計全年核心研發成本將佔總收入的 20% 左右。核心銷售、一般及行政費用增加了 3%,增幅遠低於總收入。我們預計今年的經營槓桿和利潤率將持續提高。與往年類似,我們預期下半年利潤率會下降,主要與前面提到的成長利潤率效應有關。

  • Core tax rate was 18% in the first half, which benefited from a favorable settlement in the first quarter and is anticipated to remain 18% to 22% for the full year. Core EPS of $4.66 represents 17% growth.

    上半年核心稅率為18%,受益於第一季有利的結算,預計全年將維持在18%至22%之間。核心每股收益 4.66 美元,代表成長 17%。

  • Next slide, please. As I just mentioned, the increase in R&D costs was driven in part by accelerated clinical trial recruitment, with more than 50% of our trials recruiting significantly ahead of plan. We have seen a growing number of patients in our clinical trials, and by the end of the second quarter, the total had reached 56,000 patients. We also saw increased investments in our transformative technologies, including in our IO biospecifics, our in-house ADCs, cell therapy, as well as our growing portfolio in cardiovascular renal medicines.

    請看下一張投影片。正如我剛才提到的,研發成本的增加部分是由於臨床試驗招募的加速,我們超過 50% 的試驗招募大大提前於規劃。我們看到參加臨床試驗的患者數量不斷增加,截至第二季末,患者總數已達 56,000 名。我們也看到對變革性技術的投資增加,包括我們的IO生物特異性,我們的內部ADC,細胞療法,以及我們不斷增長的心血管腎臟藥物產品組合。

  • We continue to make investments not only to achieve our 2030 ambitions, but also to drive continued growth beyond 2030. Given the breadth and depth of our portfolio, we anticipate R&D costs to remain in the low 20s percentage range of total revenue for the longer term. On the SG&A side, I'm pleased to report that we're making great progress, and I would like to thank all our teams globally. We are seeing productivity gains from initiatives undertaken in the last few years, including the redeployment of resources, utilization of shared service centers, and investments in digital and AI, all of which have led to SG&A costs increasing by only 3% in the first six months, despite the high number of new launches.

    我們持續投資,不僅是為了實現我們的2030年目標,也是為了推動2030年以後的持續成長。鑑於我們產品組合的廣度和深度,我們預計研發成本在長期內將維持在總收入的 20% 以下。在銷售、一般及行政費用方面,我很高興地報告,我們正在取得巨大進展,我要感謝我們全球的所有團隊。我們看到過去幾年採取的舉措帶來了生產力的提高,包括資源的重新部署、共享服務中心的利用以及對數位和人工智慧的投資,儘管新推出的產品數量很多,但所有這些舉措都導致上半年銷售、一般和行政費用僅增加了 3%。

  • Next slide, please. We are reiterating our guidance for the year where we anticipate high single-digit percentage increase in revenue and low double-digit percentage increase in EPS. We have had strong performance in the first half and expect that momentum to continue in our core products. But note that the BRILINTA LOE, Soliris Biosimilar, and products like FluMist are more second-half weighted, and there's uncertainty regarding FORXIGA.

    請看下一張投影片。我們重申今年的預期,預計收入將實現高個位數百分比成長,每股收益將實現低兩位數百分比成長。我們上半年表現強勁,預計核心產品將持續維持這一動能。但請注意,BRILINTA LOE、Soliris Biosimilar 和 FluMist 等產品在下半年的權重更大,而 FORXIGA 存在不確定性。

  • Also note that the year-on-year growth rate in the second half will be skewed by the $600 million LYNPARZA-related milestone received in the fourth quarter of 2024. Net cash flow from operating activities increased by 27% to $7.1 billion in the first half. As previously communicated, we expect CapEx to increase by 50% this year, with $1.3 billion spent year-to-date. As a reminder, our total CapEx, including both tangible and software-related intangible assets, was $2.2 billion last year.

    還要注意的是,下半年的年成長率將受到 2024 年第四季收到的 6 億美元 LYNPARZA 相關里程碑的影響。上半年營運活動淨現金流成長27%,達71億美元。正如之前所傳達的,我們預計今年的資本支出將增加 50%,年初至今已支出 13 億美元。提醒一下,去年我們的總資本支出(包括有形資產和軟體相關的無形資產)為 22 億美元。

  • Earlier this month, we announced a new multi-billion dollar manufacturing facility in the US, that will produce drug substance for innovative weight management and metabolic portfolio, including our oral GLP-1, baxdrostat, oral PCSK9, and combination small molecule products. This facility makes up part of the recently announced $50 billion investment plan in the United States, which also includes R&D spend, operating expenses, and investments across several of our existing sites. These investments are in line with our previously stated objectives to increase both our manufacturing and R&D footprints in the US.

    本月初,我們宣佈在美國建立一家價值數十億美元的新製造工廠,該工廠將生產用於創新體重管理和代謝產品組合的藥物,包括我們的口服 GLP-1、baxdrostat、口服 PCSK9 和組合小分子產品。該工廠是最近宣布的美國 500 億美元投資計畫的一部分,該計畫還包括研發支出、營運費用以及對我們現有多個工廠的投資。這些投資符合我們先前提出的擴大在美國製造和研發影響力的目標。

  • Deal payments of $2.3 billion in the first half included an Enhertu milestone and an approximately $400 million upfront payment for the EsoBiotec acquisition, which closed in the second quarter. Net debt increased by $650 million in the first half, driven by the dividend payment made in the first quarter. We remain comfortable with our current level of debt and decrease in the net debt EBITDA ratio to 1.4 times reflects our improving operating cash flow.

    上半年 23 億美元的交易支付包括 Enhertu 的里程碑付款以及第二季完成的 EsoBiotec 收購的約 4 億美元預付款。由於第一季支付股息,上半年淨債務增加了 6.5 億美元。我們對目前的債務水準感到滿意,淨債務 EBITDA 比率下降至 1.4 倍反映了我們經營現金流的改善。

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

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

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thank you, Aradhana. Next slide, please. Oncology total revenues grew 16% in the first half to $12 billion, underpinned by strong double-digit growth across US, Europe and emerging markets. Growth in the US was particularly notable, up 19%, with demand growth substantially offsetting the impact of the Medicare Part D redesign rebates, which started at the beginning of 2025.

    謝謝你,阿拉達納。請看下一張投影片。上半年腫瘤學總收入成長 16%,達到 120 億美元,這得益於美國、歐洲和新興市場的強勁兩位數成長。美國的成長尤其顯著,成長了 19%,需求成長大大抵消了 2025 年初開始實施的醫療保險 D 部分重新設計退款的影響。

  • Turning now to quarterly performance for our key medicines. We saw double-digit growth across all key brands this quarter. Tagrisso delivered 12% growth in the second quarter, reflecting strong demand across all indications. The market share for the FLAURA2 regimen continues to expand and the recently announced positive overall survival results reinforce Tagrisso's position as the frontline standard of care in EGFR-mutated lung cancer.

    現在來談談我們主要藥物的季度表現。本季度,所有主要品牌均實現了兩位數的成長。Tagrisso 在第二季實現了 12% 的成長,反映出各方面需求強勁。FLAURA2 方案的市場份額持續擴大,最近公佈的積極總體生存結果鞏固了 Tagrisso 作為 EGFR 突變肺癌一線治療標準的地位。

  • Overall, we anticipate continued sequential growth across all indications through the remainder of the year. Calquence remains the leading BTK inhibitor across major markets with total revenues increasing by 10% and to $872 million in the second quarter. In the US, we saw growth in new patient starts having secured preferential formulary placement in CLL across several commercial plans driving frontline share gains.

    總體而言,我們預計今年剩餘時間內所有指標都將繼續保持環比成長。Calquence 仍然是主要市場領先的 BTK 抑制劑,第二季總營收成長 10%,達到 8.72 億美元。在美國,我們看到新患者數量的增長,他們在多個商業計劃中獲得了 CLL 的優先處方權,從而推動了前線份額的增長。

  • We also saw a strong uptake in the first-line mantle cell lymphoma following the approval of ECHO in January. Looking ahead, we see meaningful growth potential for the fixed duration AMPLIFY regimen in CLL following its recent approval in Europe, and filing except in the US. Lynparza remains the leading PARP inhibitor globally with 11% growth in the second quarter. In the US, we saw new share gains in both prostate and breast cancer, alongside robust growth in Medicare. We anticipate further volume growth globally to partially offset potential impact of VBP inclusion in China anticipated later this year.

    繼 ECHO 於一月份獲得批准後,我們也看到一線套細胞淋巴瘤的強勁增長。展望未來,我們認為固定療程的 AMPLIFY 方案在慢性淋巴細胞白血病 (CLL) 治療中具有顯著的成長潛力,因為該方案最近已在歐洲獲得批准,並在美國以外地區提交了申請。Lynparza 仍然是全球領先的 PARP 抑制劑,第二季度成長了 11%。在美國,我們看到攝護腺癌和乳癌的市佔率均有成長,同時醫療保險也實現了強勁成長。我們預計全球銷售將進一步成長,以部分抵消今年稍後中國納入 VBP 的潛在影響。

  • Truqap delivered $170 million in second quarter revenues, reflecting 84% growth compared to Q2 last year. We continue to see growing demand in the core second-line patient segment. And as we reported last quarter, we've achieved nearly 100% market share in the AKT PTEN biomarker altered population. Further growth will be driven by increased uptake within the PIK3CA population and additional global launches. We saw particularly strong growth of Imfinzi and Imjudo in the second quarter, up 26% and 18%, respectively.

    Truqap 第二季營收為 1.7 億美元,較去年第二季成長 84%。我們持續看到核心二線患者群體的需求不斷增長。正如我們上個季度報告的那樣,我們在 AKT PTEN 生物標記改變人群中取得了近 100% 的市場份額。PIK3CA 族群的接受度增加和全球範圍內的更多推出將推動進一步的成長。我們看到 Imfinzi 和 Imjudo 在第二季度的成長尤為強勁,分別成長了 26% 和 18%。

  • In the US, there's been rapid early uptake of new Imfinzi regimens. ADRIATIC and AEGEAN in lung cancer in NIAGARA in bladder cancer as well as continued momentum in the established lung and liver indications. The strong launch of ADRIATIC and small cell lung cancer in Europe more than offset the increased competitive pressures in biliary tract cancer in Japan. We remain focused on driving further adoption of Imfinzi and Imjudo with additional launches for NIAGARA, ADRIATIC and AEGEAN accepted in the coming months, and with MATTERHORN and gastric cancer set to contribute significantly to growth 2026.

    在美國,新的 Imfinzi 療法得到了快速的早期採用。ADRIATIC 和 AEGEAN 在肺癌治療領域、NIAGARA 在膀胱癌治療領域均表現出色,並且在已確立的肺癌和肝癌適應症方面也保持了持續增長勢頭。ADRIATIC 和小細胞肺癌在歐洲的強勁推出足以抵消日本膽道癌領域日益加劇的競爭壓力。我們將繼續致力於推動 Imfinzi 和 Imjudo 的進一步應用,並在未來幾個月內接受 NIAGARA、ADRIATIC 和 AEGEAN 的更多應用,MATTERHORN 和胃癌治療將為 2026 年的成長做出重大貢獻。

  • Enhertu total revenues grew 42% in the second quarter, reflecting sustained market leadership in both HER2+ and HER2- metastatic breast cancer. We're seeing strong initial uptake in China within HER2 on the back of a very rapid road hospital formulary listings following NRDL enlistment in January. We see accelerating uptake for DESTINY-Breast06 with momentum building in the US and early use in the chemotherapy naive segment emerging in European markets following approval in April.

    Enhertu 在第二季總營收成長了 42%,反映出其在 HER2+ 和 HER2- 轉移性乳癌領域的持續市場領導地位。我們看到,隨著 1 月 HER2 藥物被納入國家醫療保健目錄,隨著醫院處方集的快速增加,中國 HER2 藥物的初始應用量強勁增長。我們看到 DESTINY-Breast06 的吸收正在加速,在美國勢頭強勁,並且在 4 月獲得批准後,在歐洲市場也出現了未接受化療的患者群體的早期使用。

  • Datroway is gaining traction in hormone receptor positive HER2- breast cancer with early positive signals and share gains across key markets. We expect growth to accelerate through the remainder of the year, following the recent US approval and NCCN guideline inclusion for patients with previously treated advanced EGFR mutated lung cancer. With strong momentum across our portfolio, we are well positioned for continued growth through the rest of the year as we deliver innovative oncology medicines to more patients across the globe.

    Datroway 在荷爾蒙受體陽性 HER2 乳癌領域正獲得關注,早期呈現陽性訊號,並在主要市場佔有份額。我們預計,隨著美國最近批准該藥物並將其納入先前接受過治療的晚期 EGFR 突變肺癌患者的 NCCN 指南,今年剩餘時間內該藥物的增長將會加速。憑藉我們產品組合的強勁發展勢頭,我們已準備好在今年剩餘時間內繼續成長,為全球更多患者提供創新的腫瘤藥物。

  • With that, please advance to the next slide, and I'll hand over to Susan to cover 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. This year at ASCO, AstraZeneca delivered multiple data sets with the potential to transform clinical factors including two plenary presentations. This marks the seventh consecutive year our science has been selected for the ASCO plenary recession, highlighting both the caliber and consistent impact of our research and underscoring the value our data brings to patients, to clinicians and the wider oncology community.

    謝謝你,戴夫。今年在 ASCO 上,阿斯特捷利康提供了多個可能改變臨床因素的數據集,其中包括兩次全體會議報告。這標誌著我們的科學連續第七年入選 ASCO 全體會議,凸顯了我們研究的品質和持續影響,並強調了我們的數據為患者、臨床醫生和更廣泛的腫瘤學界帶來的價值。

  • The SERENA-6 data replant the first Phase III results for camizestrant on next generation oral SERD and complete ER antagonist which is an exciting new molecular entity with best-in-class potential.

    SERENA-6 數據重現了卡米司群在下一代口服 SERD 和完全 ER 拮抗劑方面的首個 III 期結果,卡米司群是一種令人興奮的新型分子實體,具有同類最佳的潛力。

  • The key first line treatment objective for patients with hormone receptor positive advanced breast cancer is to prolong the time until disease progression whilst maximizing quality of life. In this interim analysis, camizestrant plus a CDK4/6 inhibitor reduce the risk of progression or death by 56% compared to an aromatase inhibitor plus CDK4/6 inhibition and showed an encouraging trend for improvement in second progression-free survival.

    荷爾蒙受體陽性晚期乳癌患者的主要第一線治療目標是延長病情進展的時間,同時最大限度地提高生活品質。在本次中期分析中,與芳香化酶抑制劑加上 CDK4/6 抑制劑相比,卡米司群加 CDK4/6 抑制劑可將進展或死亡風險降低 56%,並顯示出第二次無惡化存活期改善的令人鼓舞的趨勢。

  • Camizestrant also demonstrated a very well-tolerated safety profile with a discontinuation rate due to adverse events of less than 1.5%. And it meaningfully prolong the time patients maintain their quality of life, by a median of over 16 months. The significance of these finding is reinforced by the recent breakthrough therapy designation granted by the FDA.

    Camizestrant 也表現出了非常好的耐受性安全性,因不良事件而停藥的比例不到 1.5%。並且顯著延長了患者維持生活品質的時間,平均延長了16個月以上。FDA 最近授予的突破性療法認定進一步證明了這些發現的重要性。

  • The DESTINY-Breast09 trial moves Enhertu one line earlier in the treatment of metastatic HER2+ breast cancer into the first line setting. The trial demonstrated the combination of Enhertu plus pertuzumab resulted in a median progression-free survival of more than three years, the 44% reduction in the risk of progression or death compared to the standard of care 3-drug regimen, THP.

    DESTINY-Breast09 試驗使 Enhertu 在轉移性 HER2+ 乳癌治療中提前進入第一線治療。試驗表明,Enhertu 與帕妥珠單抗聯合治療可使無進展生存期中位數超過三年,與標準三藥療法 THP 相比,進展或死亡風險降低了 44%。

  • There was also a strong trend, second progression-free survival benefit and an early trend towards overall survival benefit. Treating HER2+ breast cancer at the earliest opportunity with the most effective therapy is critical. As approximately a third of patients diagnosed with metastatic disease don't go on to receive a second line of therapy. These data establish Enhertu as a potential first-line option for HER2+ breast cancer, and their value has been recognized by the FDA, who recently also granted this dataset breakthrough therapy designation.

    此外還有一個強勁的趨勢,即第二次無惡化存活獲益和整體存活獲益的早期趨勢。儘早採用最有效的療法治療 HER2+ 乳癌至關重要。因為大約三分之一的轉移性疾病患者沒有繼續接受第二線治療。這些數據確立了 Enhertu 作為 HER2+ 乳癌潛在一線治療選擇的地位,其價值也得到了 FDA 的認可,FDA 最近也授予該數據集突破性療法稱號。

  • MATTERHORN demonstrated a significant in event-free survival for perioperative Imfinzi plus FLOT chemotherapy compared with FLOT alone. With two thirds patients with resectable gastric or gatheresophageal cancer remaining event free at two years and with a strong trend towards improved overall survival.

    MATTERHORN 研究證明,與單獨使用 FLOT 相比,圍手術期 Imfinzi 合併 FLOT 化療的無事件存活率顯著提高。三分之二的可切除胃癌或食道癌患者在兩年內無復發,且整體存活率有顯著提高。

  • This represents the third perioperative regimen for Imfinzi after AEGEAN and NIAGARA and introduces a new treatment approach in a disease where options have traditionally been limited. We're delighted that MATTERHORN has been granted priority review by the FDA. This quarter, we also reported three key high-level data readouts, DESTINY-Breast11, POTOMAC, and FLAURA2 overall survival.

    這是繼 AEGEAN 和 NIAGARA 之後 Imfinzi 的第三種圍手術期治療方案,為傳統治療選擇有限的疾病引入了一種新的治療方法。我們很高興 MATTERHORN 獲得了 FDA 的優先審查。本季度,我們也報告了三個關鍵的進階資料讀數,DESTINY-Breast11、POTOMAC 和 FLAURA2 整體存活率。

  • DESTINY-Breast11 moves in Enhertu into the neoadjuvant early breast cancer setting, where the chance for cure is at its highest. The trial focuses specifically on patients with [Harris] disease, where there's a large unmet need with nearly half of patients not currently giving a pathologic complete response to treatment and many struggling to tolerate current standard of care combination chemotherapy regimens.

    DESTINY-Breast11 在恩赫圖進入新輔助早期乳癌治療領域,這裡的治癒機會最高。該試驗專門針對患有 [哈里斯] 病的患者,該類患者存在大量未滿足的需求,目前近一半的患者在治療後沒有出現病理完全反應,許多患者難以忍受目前的標準治療聯合化療方案。

  • Enhertu followed by THP demonstrate a statistically significant and clinically meaningful improvement in pathologic complete response rate compared to standard of care with a trend to improve event-free survival and an improved safety profile versus (inaudible) followed by THP. The full data will be presented at ESMO later this year. Data from our other early breast cancer Enhertu trial DESTINY-Breast05 which looks at adjuvant Enhertu in high-risk patients post surgery are also expected later this year.

    與標準治療相比,Enhertu 合併 THP 治療在病理完全緩解率方面表現出統計學上顯著且有臨床意義的改善,並且有改善無事件生存率的趨勢,並且與(聽不清楚)聯合 THP 治療相比,其安全性也得到改善。完整數據將於今年稍晚在 ESMO 上公佈。我們另一項早期乳癌 Enhertu 試驗 DESTINY-Breast05 的數據也預計將於今年稍後公佈,該試驗研究的是高風險患者術後輔助 Enhertu 治療。

  • In addition, we recently initiated our first trial of subcutaneous Enhertu, which has the potential to further improve the patient experience across our broad range of indications. POTOMAC moves Imfinzi into the earliest treatment space of non-muscle invasive cancer. With Imfinzi plus BCG induction and maintenance demonstrating an improvement in the time until disease recurrence or progression compared to BCG alone.

    此外,我們最近啟動了皮下 Enhertu 的首次試驗,這有可能進一步改善我們廣泛適應症的患者體驗。POTOMAC 將 Imfinzi 帶入非肌肉浸潤性癌症的最早治療領域。Imfinzi 合併 BCG 誘導和維持治療與單獨使用 BCG 相比,可縮短疾病復發或進展的時間。

  • These data will be presented later this year. Alongside the trials we have in muscle-invasive disease, the recently approved NIAGARA trial and the ongoing VOLGA trial, POTOMAC potentially broadens and reinforces Imfinzi's position in bladder cancer. Both DESTINY-Breast1 and POTOMAC underscore our commitment to bring transformative treatments into the earlier lines of care to maximize the chance of cure.

    這些數據將於今年稍後公佈。除了我們在肌肉侵襲性疾病方面進行的試驗、最近批准的 NIAGARA 試驗和正在進行的 VOLGA 試驗之外,POTOMAC 還可能擴大和加強 Imfinzi 在膀胱癌領域的地位。DESTINY-Breast1 和 POTOMAC 都強調了我們致力於將變革性治療引入早期護理以最大限度提高治癒機會的承諾。

  • Finally, I also want to briefly highlight, as Dave mentioned, the recent announcement that FLAURA2 demonstrated a statistically significant and clinically meaningful improvement in overall survival versus Tagrisso monotherapy. These data reinforce the impact of Tagrisso and its role as the backbone therapy across all stages of EGFR mutated lung cancer. And we also look forward to sharing these data later this year.

    最後,正如戴夫所提到的,我還想簡要強調一下最近宣布的 FLAURA2 與 Tagrisso 單藥療法相比,在總體生存率方面表現出了統計學上顯著且具有臨床意義的改善。這些數據強化了 Tagrisso 的影響及其作為 EGFR 突變肺癌各階段的骨幹療法的作用。我們也期待在今年稍後分享這些數據。

  • 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,我將交給 Ruud 來介紹生物製藥的表現。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Thank you so much, Susan. Next slide, please. Our biopharmaceuticals medicines continued to deliver strong performance in the first half with double-digit growth of 10%, taking total revenue to $11.2 billion. R&I continued its impressive momentum with total revenue of $4.2 billion, up 13%, with growth medicines now making up 60% of the therapy areas revenue. CVRM achieved total revenue of $6.6 billion, growth of 8%.

    非常感謝,蘇珊。請看下一張投影片。我們的生物製藥產品在上半年持續表現強勁,實現了10%的兩位數成長,總收入達到112億美元。研發與創新繼續保持令人印象深刻的勢頭,總收入達到 42 億美元,成長 13%,其中成長藥物目前佔治療領域收入的 60%。CVRM 實現總營收 66 億美元,成長 8%。

  • We are consistently seeing robust performances from our key medicines in R&I each quarter. Fasenra grew 18% to $502 million in the second quarter. We have now launched Fasenra in China and in the United States, we saw strong uptake in the new EGPA indication where Fasenra has already achieved leading share of new-to-brand prescriptions.

    我們每季都看到我們的主要藥物在研發方面表現強勁。Fasenra 在第二季成長 18%,達到 5.02 億美元。我們目前已在中國和美國推出了 Fasenra,我們看到新的 EGPA 適應症的強勁增長,其中 Fasenra 已在品牌新處方中佔據領先份額。

  • We also had the positive readout for the (inaudible) trial in hypereosinophilic syndrome in June, and we are awaiting the results of the RESOLUTE trial of Fasenra in COPD due in the second half of this year. Tezspire grew by 65% in the second quarter and has achieved leading new-to-brand biologics share in asthma across key markets. The regulatory review of the WAYPOINT data in nasal polyps is well underway, and we are looking forward to launching this new indication in the second half.

    6 月份,我們還獲得了嗜酸性粒細胞增多綜合症 (OCR) 治療試驗的積極結果,目前正在等待今年下半年 Fasenra 治療 COPD 的 RESOLUTE 試驗結果。Tezspire 在第二季度成長了 65%,並在主要市場的氣喘領域取得了領先的新品牌生物製劑份額。WAYPOINT 在鼻息肉方面的數據監管審查正在順利進行中,我們期待在下半年推出這項新適應症。

  • The SPY is also being investigated in COPD with its Phase III program ongoing. Breztri was up 20% in the second quarter, benefiting from growing adoption of in health triple therapies in COPD and now has the potential to expand into asthma following the positive readout from the [CLOs] and low-cost trials in May.

    SPY 也在 COPD 領域進行研究,其 III 期計畫正在進行中。Breztri 的股價在第二季上漲了 20%,這得益於慢性阻塞性肺病 (COPD) 健康三聯療法的日益普及,隨著 5 月 [CLO] 和低成本試驗的積極結果,該公司現在有可能擴展到氣喘領域。

  • Demand for Airsupra remains impressive with the clinical proposition in moderate asthma strengthened by the BATURA trial, results of which were published in the New England Journal of Medicine in May. Saphnelo grew by 48% this quarter and has steadily gained share among systemic lupus erythematosis patients treated with intravenous infusion, and we are looking forward to the results of TULIP [sc], our subcutaneous trial later this year.

    由於 BATURA 試驗加強了 Airsupra 對中度氣喘的臨床主張,市場對 Airsupra 的需求仍然強勁,該試驗的結果於 5 月發表在《新英格蘭醫學雜誌》上。Saphnelo 本季成長了 48%,在接受靜脈輸液治療的系統性紅斑狼瘡患者中的份額穩步增長,我們期待今年晚些時候皮下試驗 TULIP [sc] 的結果。

  • CVRM grew by 3% in the second quarter with continued demand for Farxiga and Lokelma, offsetting the expected impact of Brilinta generic competition in the United States and European markets. Farxiga's strong trajectory continued with revenues up 10% to $2.2 billion in the quarter. In the second half, we expect demand to continue to increase. However, revenues in China are expected to be impacted by the VBP implementation.

    由於對 Farxiga 和 Lokelma 的需求持續增長,CVRM 在第二季度增長了 3%,抵消了 Brilinta 仿製藥在美國和歐洲市場競爭的預期影響。Farxiga 持續保持強勁成長勢頭,本季營收成長 10%,達到 22 億美元。下半年,我們預計需求將持續增加。然而,預計中國的收入將受到 VBP 實施的影響。

  • Lokelma delivered another impressive quarter with revenues of $175 million and growth of 27%. Lokelma is the leading potassium binder in chronic kidney disease and heart failure. We firmly believe that Lokelma has blockbuster potential, giving opportunities for further regional expansion. Wainua delivered $44 million in the quarter, including the first sales in ex-US markets. We are excited for the cardio transform trial of Wainua, the Phase III trial in ATTR cardiomyopathy, which is due to read out in the second half of 2026. This is the largest trial in this population and has the potential to address key questions regarding the optimal use of silencers and stabilizers to treat this debilitating and deadly disease.

    Lokelma 又一個季度取得了令人印象深刻的成績,營收達到 1.75 億美元,成長率達到 27%。Lokelma 是治療慢性腎臟病和心臟衰竭的主要鉀結合劑。我們堅信,Lokelma 具有巨大的潛力,為進一步的區域擴張提供了機會。Wainua 本季的銷售額為 4,400 萬美元,其中包括在美國以外市場的首次銷售。我們對 Wainua 的心臟轉化試驗感到非常興奮,這是 ATTR 心肌病變的 III 期試驗,預計將於 2026 年下半年完成。這是針對該族群進行的最大規模試驗,有可能解決有關如何最佳地使用消音器和穩定劑來治療這種使人衰弱且致命的疾病的關鍵問題。

  • And finally, we were particularly excited to see the first positive Phase III readout for baxdrostat earlier this month.

    最後,我們特別高興地看到本月早些時候 baxdrostat 的第一個積極的 III 期讀數。

  • And with that, I will hand over to Sharon.

    現在,我將把時間交給莎倫。

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

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Thanks, Ruud. Next slide, please. I'm pleased to share the positive high-level results from the BaxHTN Phase III trial of baxdrostat in uncontrolled resistant hypertension, which were announced earlier this month. Hypertension is a leading modifiable risk factor for heart attack, stroke, heart failure and kidney disease, and it remains a huge unmet medical need. Currently, nearly 50% of adults in the US live with hypertension and half of those patients still have inadequately controlled blood pressure despite taking multiple medications.

    謝謝,魯德。請看下一張投影片。我很高興與大家分享本月早些時候宣布的 BaxHTN III 期試驗中巴曲司他治療未控制的難治性高血壓的積極高水平結果。高血壓是心臟病發作、中風、心臟衰竭和腎臟疾病的主要可改變風險因素,並且仍然是一個巨大的未滿足的醫療需求。目前,美國近50%的成年人患有高血壓,其中一半患者儘管服用多種藥物,但血壓仍無法充分控制。

  • With no new treatments for over two decades, baxdrostat has the potential to be a first-in-class, highly selective aldosterone synatase inhibitor that targets the hormone driving elevated blood pressure, leading to increased cardiovascular and renal risk. It's designed to reduce aldosterone production at its source, delivering a highly targeted approach that may help avoid the hormonal side effects often associated with current therapies.

    由於二十多年來一直沒有新的治療方法,巴曲司他有可能成為一流的、高選擇性醛固酮合成酶抑制劑,其針對的是導致血壓升高的激素,從而增加心血管和腎臟風險。其目的是從源頭減少醛固酮的產生,提供高度針對性的方法,可能有助於避免目前療法中常見的荷爾蒙副作用。

  • In BaxHTN, 796 patients with uncontrolled or treatment-resistant hypertension were randomized one to one to one to receive 1 mg or 2 mgs of baxdrostat or placebo on top of standard of care without the need for dose titration. The primary endpoint was change in ceded systolic blood pressure or SPP, measured at 12 weeks using automated office blood pressure readings.

    在 BaxHTN 研究中,796 名患有未控製或難治性高血壓的患者被隨機一對一分配接受 1 毫克或 2 毫克的 baxdrostat 或安慰劑,同時接受標準治療,無需調整劑量。主要終點是收縮壓或 SPP 的變化,使用自動辦公室血壓讀數在 12 週時進行測量。

  • Secondary endpoints included assessment of ceded SPP after randomized withdrawal of treatment from weeks 24 to 36 and ceded SPP in the subpopulation of patients with resistant hypertension and the proportion of patients achieving SPP below 130 millimeters of mercury at week 12, alongside safety and tolerability measures. We are delighted that both doses of baxdrostat demonstrated statistically significant and clinically meaningful reductions in SPP at 12 weeks, and the trial also met all secondary endpoints. Baxdrostat was generally well tolerated in the trial, with a favorable safety profile.

    次要終點包括評估第 24 至 36 週隨機停止治療後的 SPP 損失、難治性高血壓患者亞群中的 SPP 損失以及第 12 週時 SPP 達到 130 毫米汞柱以下的患者比例,以及安全性和耐受性措施。我們很高興看到,兩種劑量的巴曲司他在第 12 週均表現出統計學上顯著且具有臨床意義的 SPP 降低,並且試驗也達到了所有次要終點。巴曲司他在該試驗中整體耐受性良好,且具有良好的安全性。

  • The robust trial design of BAxHTN gives us great confidence in the data, and these results add to the compelling body of evidence supporting baxdrostat's clinical promise in addressing a critical unmet need in this hard-to-treat population. We look forward to presenting these data at the upcoming European Society of Cardiology meeting in the late-breaking hotline session next month and are working at pace to share these data with the regulatory authorities.

    BAxHTN 的穩健試驗設計使我們對數據充滿信心,這些結果進一步證明了巴曲司他 (baxdrostat) 在解決這一難以治療人群中的關鍵未滿足需求方面的臨床前景。我們期待在下個月即將舉行的歐洲心臟病學會會議的最新熱線會議上展示這些數據,並正在努力與監管機構分享這些數據。

  • Our ongoing Phase III development program for baxdrostat is broad with six additional clinical trials enrolling more than 20,000 patients. We believe the long half life of baxdrostat is a key differentiator for this potential medicine supporting 24-hour systolic blood pressure control, and we are looking forward to confirming this in the Bax24 trial due to read out later this year. We are looking to extend the potential reach of baxdrostat across the globe and BaxAsia will provide us with data for the Asian population in the first half of next year.

    我們正在進行的巴曲司他 III 期開發計畫範圍廣泛,另有六項臨床試驗招募了超過 20,000 名患者。我們相信,巴曲司他的長半衰期是這種支持 24 小時收縮壓控制的潛在藥物的關鍵區別因素,我們期待在今年稍後宣讀的 Bax24 試驗中證實這一點。我們希望擴大 baxdrostat 在全球範圍內的潛在覆蓋範圍,BaxAsia 將在明年上半年為我們提供亞洲人口的數據。

  • We are also in the process of initiating a new trial. BaxPA in primary aldosteronism. This is a condition where excess aldosterone is driving hypertension, electrolyte imbalances and longer-term cardiovascular risk. Beyond this, we are rapidly advancing the combination of baxdrostat and dapagliflozin, with three Phase III trials ongoing, two of which are outcome studies. BaxDUO-Arctic investigates whether the combination can slow the progression of chronic kidney disease.

    我們也正在啟動一項新的試驗。原發性醛固酮增多症中的 BaxPA。在這種情況下,過量的醛固酮會導致高血壓、電解質失衡和長期心血管風險。除此之外,我們正在迅速推進巴曲司他和達格列淨的組合治療,目前正在進行三項 III 期試驗,其中兩項是結果研究。BaxDUO-Arctic 研究這種組合是否可以減緩慢性腎臟病的進展。

  • BaxDUO-Pacific initiated in 2024, looks at whether the combination reduces the risk of kidney decline or failure and cardiovascular death. Prevent-HF started this year is the first of its kind trial and investigates whether the combination results in reduction of heart failure events and cardiovascular death.

    BaxDUO-Pacific 於 2024 年啟動,旨在研究這種組合是否可以降低腎衰竭和心血管死亡的風險。今年啟動的 Prevent-HF 試驗是同類試驗中的首次,旨在研究這種組合是否能夠減少心臟衰竭事件和心血管死亡。

  • We are very excited with the strong momentum across our CVRM pipeline, underpinned by multiple novel approaches and our ability to explore unique multi-mechanism combinations to address interrelated CVRM diseases.

    我們對 CVRM 管道的強勁發展勢頭感到非常興奮,這得益於多種新方法以及我們探索獨特的多機制組合以解決相互關聯的 CVRM 疾病的能力。

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

    接下來,請繼續觀看下一張投影片,我將把主題交給馬克,讓他介紹罕見疾病。

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

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

  • Thank you, Sharon. Can I get the next slide, please. Rare disease medicine returned to growth in the second quarter with total revenue up 7%, resulting in 3% growth in the first half to $4.3 billion. In the second quarter, Ultomiris grew 23%, driven by patient demand across indications, including the competitive generalized myasthenia gravis and paroxysmal nocturnal hemoglobinuria markets.

    謝謝你,莎倫。我可以得到下一張投影片嗎?罕見疾病藥物在第二季度恢復成長,總收入成長 7%,導致上半年成長 3% 至 43 億美元。第二季度,Ultomiris 成長了 23%,這得益於患者對各種適應症的需求,包括競爭激烈的全身性重症肌無力和陣發性睡眠性血紅蛋白尿市場。

  • Soliris revenues continued to decline due to the successful conversion to Ultomiris as well as biosimilar pressure in Europe. This decline was partially offset by order timing in tender markets. Beyond complement, both Strensiq and Koselugo grew 15% and 18%, respectively, driven by continued patient demand.

    由於成功轉換為 Ultomiris 以及歐洲的生物相似藥壓力,Soliris 的收入持續下降。這一下降被招標市場的訂單時間部分抵消。除了補充之外,在持續的患者需求的推動下,Strensiq 和 Koselugo 分別增加了 15% 和 18%。

  • Please advance to the next slide. We recently reported Phase III readouts for two new molecular entities, gefurulimab and anselamimab. We are excited by our Phase III PREVAIL trial investigating gefurilumab or dual binding nanobody targeting C5 in patients we generalize myasthenia gravis, meeting all endpoints.

    請前進到下一張幻燈片。我們最近報告了兩種新分子實體 gefurulimab 和 anselamimab 的 III 期讀數。我們對 III 期 PREVAIL 試驗感到非常興奮,該試驗研究了吉非魯單抗或針對 C5 的雙結合奈米抗體在我們治療的重症肌無力患者中的作用,並達到了所有終點。

  • Gefurulimab demonstrated a statistically significant and clinically meaningful improvements from baseline in myasthenia gravis activities of daily living total score at week 26 compared to placebo. The PREVAIL trial was conducted in a broader GMG patient population compared with prior trials of C5-targeted therapies. And we are highly encouraged by gefurulimab rapid complete and sustained complement inhibition with improvements in both patients and (inaudible) reported outcomes.

    與安慰劑相比,吉夫魯利單抗在第 26 週時重症肌無力日常生活活動總分較基線有統計學上顯著且有臨床意義的改善。與先前針對 C5 的治療方案的試驗相比,PREVAIL 試驗在更廣泛的 GMG 患者群體中進行。我們對吉芙露利單抗快速、完全和持續的補體抑制感到非常鼓舞,患者和(聽不清楚)報告的結果均有所改善。

  • Gefurulimab is self-administered subcutaneously once a week with the potential for two delivery option, a prefilled syringe and a first-class auto injector. We believe that with the strength of this data, and convenient administration, gefurulimab has a potential to become a new first-line therapy following corticosteroids immunosuppressant treatments.

    吉夫魯利單抗每週進行一次皮下注射,有兩種給藥方式:預充式註射器和一流的自動注射器。我們相信,憑藉這些數據的實力和便捷的給藥方式,吉夫利單抗有可能成為繼皮質類固醇免疫抑制劑治療之後的新的首選療法。

  • The GMG market has expanded significantly over the past three years with new branded entrants increasing disease awareness and diagnosis rates. Currently, less than 20% of patients are on branded treatments, and we expect this to increase to approximately 50% in the next three years. Additionally, self-administered medicine represents only a small part of this market today, and we expect this segment to grow substantially.

    過去三年來,隨著新品牌的進入,疾病意識和診斷率不斷提高,GMG 市場顯著擴張。目前,接受品牌治療的患者不到 20%,我們預計未來三年將增加到約 50%。此外,目前自我管理醫療僅佔該市場的一小部分,我們預計這一領域將大幅成長。

  • Moving now to anselamimab. We recently provided an update on our Phase III CARES program in patients with severe light-chain amyloidosis. While the result did not achieve statistical significance for the primary endpoint in the overall patient population, anselamimab showed a highly clinically meaningful improvement in all case mortality and cardiovascular specialization in a prespecified patient on group on top of background standard of care.

    現在轉向安塞拉米單抗。我們最近提供了針對嚴重輕鏈澱粉樣變性患者的 III 期 CARES 計劃的最新進展。雖然該結果在整體患者群體的主要終點方面未達到統計學意義,但在背景護理標準之上,安塞拉米單抗在預定組患者中顯示出所有病例死亡率和心血管專業化方面具有高度臨床意義的改善。

  • We are continuing to evaluate the full results from CARES to further characterize the efficacy and safety of anselamimab, and we intend to share this data with global health authorities. It is important to note that this is the first Phase III trial to demonstrate that targeting amyloid fibrils for depletion with specific antibodies can be highly effective in reducing test and hospitalization in amyloid driven disease. This bolsters our confidence to develop novel therapy that depletes amyloid.

    我們正在繼續評估 CARES 的全部結果,以進一步描述安塞拉米單抗的療效和安全性,並打算與全球衛生當局分享這些數據。值得注意的是,這是首次 III 期試驗,證明利用特定抗體消除澱粉樣蛋白原纖維可有效減少澱粉樣蛋白引發疾病的檢測和住院治療。這增強了我們開發消除澱粉樣蛋白的新療法的信心。

  • We're also investigating another fibril depleter, (inaudible), previously known as Alexion 2220 in transthyretin amyloid cardiomyopathy. The (inaudible) Phase III trial has now completed recruitment with more than 1,000 patients enrolled more than one year ahead of plan. This is an exciting year for rare disease pipeline with additional key trials expected to read out in the second half.

    我們也正在研究另一種纖維耗竭劑(聽不清楚),之前稱為 Alexion 2220,用於治療轉甲狀腺素蛋白澱粉樣心肌病變。(聽不清楚) 第三階段試驗現已完成招募,招募病患超過 1,000 名,比計畫提早一年多。對於罕見疾病研究而言,這是令人興奮的一年,預計下半年將有更多關鍵試驗結果公佈。

  • The (inaudible) trial of Ultomiris in ACT TMA represent an important commercial opportunity and would be the first indication for Ultomiris beyond the Soliris label. Efzimfotase alfa our next-generation enzyme replacement therapy, which is studied in broad hypophosphatasia patient population, has a potential to reach between $3 billion and $5 billion in peak sales revenue. Importantly, much of this value would be unlocked with the studies expected to read out this year.

    Ultomiris 在 ACT TMA 中的 (聽不清楚) 試驗代表著一個重要的商業機會,並且將成為 Ultomiris 在 Soliris 標籤之外的第一個適應症。Efzimfotase alfa 是我們的下一代酵素替代療法,在廣泛的低磷酸酯酶症患者群體中進行了研究,其峰值銷售收入有可能達到 30 億美元至 50 億美元。重要的是,這一價值的大部分將透過今年預計將發表的研究而釋放。

  • And finally, you may recall AstraZeneca and several partners paraded efforts to secure an update to the one Big Beautiful Bill Act, which broadens the scope of orphan drug exclusion from Medicare direct price negotiation. The [Orphan Cures Act] is a significant positive for rare disease patients. Companies will no longer be deterred from innovating in orphan indication or investigating medicine across multiple rare diseases.

    最後,您可能還記得,阿斯特捷利康和幾家合作夥伴曾努力確保對「大美麗法案」進行更新,該法案擴大了孤兒藥從醫療保險直接價格談判中排除的範圍。《孤兒藥法案》對於罕見疾病患者來說是個重大利好。公司將不再受到阻礙,不再進行孤兒藥適應症的創新或針對多種罕見疾病的藥物研究。

  • We're now working with CMS to understand the implementation process, but we believe our current and future rare disease portfolio would be protected by this legislation.

    我們目前正在與 CMS 合作以了解實施過程,但我們相信我們當前和未來的罕見疾病組合將受到該立法的保護。

  • 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帕斯卡。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc. Next slide, please. In conclusion, our company has continued to deliver strong growth in the first half of the year, driven by sustained commercial and pipeline momentum with multiple positive data readouts and important advances across our solid pipeline. Year-to-date, we've seen above industry success rates in our late-stage portfolio. Looking ahead, we have several exciting readouts over the next six months across oncology, rare disease and biopharmaceuticals.

    謝謝你,馬克。請看下一張投影片。總而言之,在持續的商業和管道發展勢頭的推動下,我們公司在上半年繼續實現強勁增長,多項積極的數據讀數以及我們堅實管道的重要進展。今年迄今為止,我們的後期投資組合的成功率高於行業水平。展望未來,我們將在未來六個月內在腫瘤學、罕見疾病和生物製藥領域公佈幾份令人興奮的數據。

  • Next slide, please. We're making significant progress towards our 2030 ambition and are confident in our growth trajectory beyond 2030 as we invest behind transformative technology that have the potential to change medical practice. We want to be a growth company to 2030 and beyond. And for that, we need to invest in technologies that will actually transform the future of medicine but also drive the company forward over the next decade and beyond. And that explain why we continue to invest heavily in research and development.

    請看下一張投影片。我們正在朝著 2030 年的目標邁進,並且對 2030 年以後的成長軌跡充滿信心,因為我們投資於有可能改變醫療實踐的變革性技術。我們希望在 2030 年及以後成為一家成長型公司。為此,我們需要投資那些能夠真正改變醫學未來的技術,同時也推動公司在未來十年及以後向前發展。這也解釋了為什麼我們繼續在研發上投入大量資金。

  • Additionally, as Aradhana mentioned, we are continuing to drive operating leverage across the company while not compromising on our investment in R&D and high-priority medicines, as I just said, we've already launched nine new medicines towards our target of 20 by 2030 and with pivotal data for five NMEs announced this year, we are very much on track to meet or even exceed this objective.

    此外,正如 Aradhana 所提到的,我們將繼續在全公司範圍內提高經營槓桿,同時不影響對研發和高優先級藥物的投資,正如我剛才所說,我們已經推出了 9 種新藥,朝著 2030 年推出 20 種新藥的目標邁進,並且隨著今年公佈的 5 種 NME 的關鍵數據,我們非常有望實現這一目標。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Please advance to the next slide, and we'll now move to the Q&A. 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. But also online, please use the raise hand function on Zoom. With that, let's now move to the first question which is from James Gordon at JPMorgan. Over to you James.

    請進入下一張投影片,我們現在進入問答環節。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。但如果線上的話,請使用 Zoom 上的舉手功能。現在讓我們進入第一個問題,來自摩根大通的詹姆斯·戈登 (James Gordon)。交給你了,詹姆斯。

  • James Gordon - Analyst

    James Gordon - Analyst

  • Hello, James Gordon, JP Morgan, thanks for taking the two questions.

    您好,摩根大通的詹姆斯戈登,感謝您回答這兩個問題。

  • The first question was on Datroway and AVANZAR and the 2030 revenue target. So just put Datroway and AVANZAR in context. So how much do you now need AVANZAR to work to deliver your $80 billion in 2030 revenue target? What baked in and what's required? And we've seen quite a lot of Phase III readouts since the $80 billion target was set last year.

    第一個問題是關於 Datroway 和 AVANZAR 以及 2030 年的收入目標。因此,只需將 Datroway 和 AVANZAR 放在上下文中即可。那麼,現在需要 AVANZAR 付出多少努力才能實現 2030 年 800 億美元的收入目標?包含哪些內容以及需要哪些內容?自從去年設定 800 億美元的目標以來,我們已經看到了相當多的第三階段數據。

  • So most favor nations aside, are you more or less confident? How has confidence changed in things outside oncology, such as say baxdrostat IL-33 or anselamimab as just was talked about. So that's the first question. How do risk things beyond Datroway?

    那麼,除了最惠國之外,您的信心是增強了還是減弱了?對於腫瘤學以外的事物,例如剛才談到的 baxdrostat IL-33 或 anselamimab,信心發生了怎樣的變化。這是第一個問題。Datroway 以外的風險如何?

  • And then the second question was on VEGF bispecific. So VEGF is a mechanism, that's got quite a lot of interest recently for lung cancer. I've seen you've started a trial of rule PD-1 (inaudible) with a CTLA-4 with or without bevacizumab, so a single agent VGEF.

    第二個問題是關於 VEGF 雙特異性的。因此,VEGF 是一種機制,最近在肺癌領域引起了廣泛關注。我看到您已經開始了規則 PD-1(聽不清楚)與 CTLA-4(有或沒有貝伐單抗)的試驗,因此是單一藥物 VGEF。

  • So I guess how exciting is VGEF? You're doing VEGF or VGEF agents exciting for combos for lung cancer, and is it better to do a mono or what about bispecific? I don't think you have a bispecific. So do you think it's better to be bispecific and get the two together or to do them by themselves?

    那我猜 VGEF 有多令人興奮?您正在開發用於治療肺癌的 VEGF 或 VGEF 藥物組合,那麼單一藥物是更好還是雙特異性藥物更好?我不認為你有雙特異性。那麼您認為雙特異性結合將兩者結合起來更好還是單獨進行更好?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, James. So maybe I'll cover quickly the first question. Susan, you might want to take the VGEF question. So on your first question, James, the answer is a straight no, we don't need Avanzar to deliver $80 billion target. Of course we hope and we believe Avanzar will be a successful trial and we'll drive that way but as we said many times before our $80 billion is a risk adjusted number across the totality of the portfolio, and as we progress with the risks, projects, baxdrostat was at least from an R&D perspective recently the risk. And we now have, of course to launch it and commercially succeed, but the risk from an R&D view point gefurulimab, an important product just the risk.

    謝謝你,詹姆斯。因此我可能會快速回答第一個問題。蘇珊,你可能想回答 VGEF 問題。因此,詹姆斯,關於你的第一個問題,答案是肯定的“不”,我們不需要 Avanzar 來實現 800 億美元的目標。當然,我們希望並相信 Avanzar 的試驗會取得成功,我們會朝著這個方向努力,但正如我們之前多次說過的那樣,我們的 800 億美元是整個投資組合中經過風險調整的數字,隨著我們風險項目的進展,baxdrostat 至少從研發角度來看最近存在風險。當然,我們現在必須將其推出並取得商業成功,但從研發的角度來看,gefurulimab 作為一款重要產品,存在一定的風險。

  • We have many other studies that we've just mentioned in the last few minutes that are not the risk and basically no longer have to be a risk adjusted in this forecast of $80 billion to 2030. So we don't need Avanzar. The last point I would make is, that we is not only about Avanzar. We already have approval in breast cancer indication. We have approval in EGFR patients post CGFR inhibitors and chemotherapy. So, Datroway is more than Avanzar. Having said that, of course, I hope that Avanzar is a positive trial. So Susan over to you for VGEF.

    我們剛才幾分鐘提到的許多其他研究都不是風險,而且基本上不再需要根據 2030 年 800 億美元的預測進行風險調整。所以我們不需要 Avanzar。我要說的最後一點是,我們不僅僅關注 Avanzar。我們已經獲得乳癌適應症的批准。我們已批准對接受 CGFR 抑制劑和化療的 EGFR 患者進行治療。因此,Datroway 不僅僅是 Avanzar。話雖如此,我當然希望 Avanzar 是一次積極的嘗試。那麼 Susan,VGEF 的職位就交給你了。

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

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

  • Yeah, sure, thanks, Pascal. So in terms of the bispecifics, obviously, as you are aware we've got our PD-1 and TIGIT rilvegostomig and PD-1 with CTLA4 for rilvegostomig is a core components of our bispecific portfolio. And what we're doing is combining those extensively with the rest of our portfolio. The profile that we've seen with rilvegostomig, I think is differentiated from other agents out there because you've got the ability to inhibit both molecules with one molecule, both targets to one particular cell with one molecule, and I think that's important.

    是的,當然,謝謝,帕斯卡。因此,就雙特異性抗體而言,顯然,如您所知,我們有 PD-1 和 TIGIT rilvegostomig,而 PD-1 與 CTLA4 rilvegostomig 是我們雙特異性抗體產品組合的核心組成部分。我們所做的就是將這些與我們投資組合的其他部分廣泛結合。我認為,我們在 rilvegostomig 中看到的特徵與其他藥物不同,因為它能夠用一個分子抑制兩種分子,用一個分子同時針對一個特定細胞,我認為這很重要。

  • What we also see because of [SFC] its silent or reduced design is really excellent safety, particularly in combination with very low discontinuation rates. So we're looking at that both in combination with chemotherapy but in combination with our extensive ADC portfolio as well. There are clearly some indications where VGEF mechanism of action has been shown over many years to have some added benefit, and we're looking at that in combination with rilvegostomig. For example, in the HCC and the gastric Gemini trials. I think there is some potential for that activity also in lung cancer, and we're also going to be investigating that in lung cancer trials as well looking at combinations with Ramucirumab.

    我們還看到,由於 [SFC] 的靜音或減量設計,其安全性確實非常出色,尤其是與非常低的停產率相結合時。因此,我們正在考慮將其與化療結合,同時也將其與我們廣泛的 ADC 產品組合相結合。有跡象表明,VGEF 作用機制多年來已被證明具有一些額外的益處,我們正在將其與 rilvegostomig 結合研究。例如,在HCC和胃Gemini試驗中。我認為這種活性在肺癌中也具有一定的潛力,我們也將在肺癌試驗中研究它,並研究與雷莫蘆單抗的聯合用藥。

  • So I think there's some potential, but the key thing is that the real value of real the rilvegostomig is its combinability across many different indications and with our ADC portfolio, and that's what we're focusing on doing that. One final point on Avanzar, that's an event-driven trial. I'll just point out that we completed a call for that at the end of 2024, actually, well ahead of schedule. It's often the case that you have to wait for the events to come, that's sometimes a positive thing.

    所以我認為它有一定的潛力,但關鍵在於,rilvegostomig 的真正價值在於它在許多不同適應症中的可組合性以及與我們的 ADC 產品組合的可組合性,而這正是我們關注的重點。關於 Avanzar 的最後一點,這是一項事件驅動的試驗。我只想指出,我們在 2024 年底就完成了這項呼籲,實際上,這比計劃提前了很多。通常情況下,你必須等待事件的發生,有時這是一件好事。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Sarita Kapila, Morgan Stanley.

    薩里塔·卡皮拉,摩根士丹利。

  • Sarita Kapila - Analyst

    Sarita Kapila - Analyst

  • Hi, thanks for taking my questions. One on finds in the second (inaudible) in HER2. So on Imfinzi, could you talk about how large the revenue opportunities are for Imfinzi across bladder cancer as well as gastric cancer. And how are you viewing the emerging competition from (inaudible)? I believe there's competing data in the NIAGARA and (inaudible) settings expected in 2027? And then secondly on HER2, could you help us understand how you expect in HER2 to be integrated into the first line positive setting in breast cancer?

    你好,謝謝你回答我的問題。其中一項發現是在 HER2 中的第二個(聽不清楚)。那麼關於 Imfinzi,您能談談 Imfinzi 在膀胱癌和胃癌治療方面的收入機會有多大嗎?您如何看待來自(聽不清楚)?我相信尼亞加拉和(聽不清楚)預計 2027 年的設定中存在相互競爭的數據?其次,關於 HER2,您能否幫助我們了解您期望如何將 HER2 整合到乳癌的第一線陽性環境中?

  • Are you expecting majority of patients to use in HER2 in line with the DB-09 protocol? Or could you see in HER2 move more to a maintenance treatment I'm sorry, in induction treatment versus maintenance as your competitor has been highlighting. And if you could just touch on the confidence of the (inaudible) and when we could expect data, please? Thank you.

    您是否預期大多數患者會依照 DB-09 方案使用 HER2?或者您會看到 HER2 更多地轉向維持治療?抱歉,正如您的競爭對手所強調的那樣,是誘導治療而不是維持治療。您能否談談(聽不清楚)的信心以及我們何時可以獲得數據?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Sarita. So Dave, two good questions for you.

    謝謝你,薩麗塔。那麼戴夫,我想問你兩個好問題。

  • You have to unmute, Dave. I mean, I keep forgetting myself that we need to unmute and unmute.

    你必須取消靜音,戴夫。我的意思是,我總是忘記我們需要取消靜音。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Sorry about that, Pascal. Sarita, thank you for the questions on this. Just an opportunity to reiterate here that both that we saw in the quarter on Imfinzi, which was quite strong, really did come from the new indications that we were launching. You call out within one of those bladder cancer and NIAGARA, and we were really pleased to see the uptake that we saw there. In terms of the size of the bladder cancer opportunity, if you look across the various studies that we have, NIAGARA, POTOMAC and then we look forward to the (inaudible) readout, bladder cancer is a blockbuster opportunity.

    很抱歉,帕斯卡。Sarita,感謝您提出這個問題。這裡只是想重申一下,我們在本季看到的 Imfinzi 表現相當強勁,這確實來自於我們推出的新適應症。您在其中一個膀胱癌和尼亞加拉中呼叫,我們真的很高興看到我們在那裡看到的吸收。就膀胱癌治療機會的規模而言,如果你看一下我們進行的各種研究,尼亞加拉、波托馬克以及我們期待的(聽不清楚)讀數,膀胱癌治療是一個巨大的機會。

  • . And certainly, the potential for competition is one that we're aware of (inaudible). But that's the reason that the Volga study is also such an important part of all of the portfolio of bladder cancer studies that we have. So far, the update that we've seen with NIAGARA has been strong, and we look forward to hopefully building on that with readout from Volga and have an opportunity for that to go forward. And I think that depending upon the readout, it's -- we'll see exactly how EV does a -- there's multiple different scenarios that could play out.

    。當然,我們也意識到了競爭的可能性(聽不清楚)。但這也是為什麼伏爾加研究也是我們所有膀胱癌研究組合中如此重要的一部分的原因。到目前為止,我們看到的 NIAGARA 更新非常強勁,我們希望能夠在此基礎上利用 Volga 的讀數,並有機會繼續向前發展。我認為,根據讀數,我們將確切地看到 EV 的表現,可能會出現多種不同的情況。

  • One of them is that Niagara continues to remain the primary standard of care going forward.

    其中之一就是尼亞加拉將繼續成為未來護理的主要標準。

  • Another is that the incorporation of EV is important, and that's why we've got a study within this setting. Within gastric cancer and specifically, we talked about the Matterhorn study. Again, I think Matterhorn is in and of itself. A blockbuster opportunity. Obviously, this is something that we need to move forward with approval.

    另一個原因是 EV 的融入非常重要,這就是我們在這種環境下進行研究的原因。具體來說,在胃癌方面,我們討論了馬特洪峰研究。再說一次,我認為馬特洪峰本身就是一個整體。一次轟動的機會。顯然,這是我們需要獲得批准才能推進的事情。

  • But I think that we heard a very positive reception at ASCO from the discussion characterizing Depot as a new standard of care moving forward. And I think that, again, when you take a look at the incidence of gastric cancer across the globe, this is an opportunity certainly for a very, very important opportunity forward and the U.S. priority review for Matterhorn, together with guidelines updates, I think, speaks really well to the opportunity there.

    但我認為,我們在 ASCO 的討論中聽到了非常積極的反響,並將 Depot 描述為未來新的護理標準。我認為,當你再次觀察全球胃癌的發生率時,這無疑是一個非常非常重要的機遇,而美國對馬特洪峰的優先審查以及指南的更新,我認為,很好地說明了那裡的機會。

  • On Enhertu, our expectation is that with the transformative 40 months and progression-free survival, clear superiority on a PFS basis over and really that, that was done in a treat progression context that we will see the utilization of DBO 9 in line with the clinical study. I think on top of that also that the CR rates versus 8% is something that has really struck the investigator community as something really, really important. And you don't know which of those patients might get those complete responses. And what we do know is that treat to progression is the design of the study that resulted in the clinical benefit that we saw within DB-09 in the Phase III. So there is certainly some interest in hypothesis and understanding certain subsegments and how duration of therapy might be modulated within those.

    對於 Enhertu,我們期望透過變革性的 40 個月無惡化存活期,在 PFS 基礎上獲得明顯優勢,並且實際上,這是在治療進展背景下完成的,我們將根據臨床研究看到 DBO 9 的利用率。我還認為,除此之外,CR 率與 8% 的對比也確實為研究人員群體帶來了非常非常重要的影響。而且你不知道哪些病人可能會得到完整的反應。我們確實知道,治療進展是這項研究的設計,它導致了我們在 III 期 DB-09 中看到的臨床益處。因此,人們肯定對假設和理解某些子部分以及如何在其中調節治療持續時間感興趣。

  • But I don't expect that it launched that, that's what we're going to see. And I would also just point to that we've seen treat to progression as the primary behavior that we see with '03, '04 and '06 in the marketplace. And while DB09 is a slightly different context, I again expect that, that to be the predominant behavior that we'll see forward so that patients get the best chance to achieve the results that we're seeing within the studies.

    但我並不期望它能推出這個,這就是我們將要看到的。我還想指出的是,我們已經看到,在 2003、2004 和 2006 年的市場上,對待進步的態度是主要行為。儘管 DB09 的情況略有不同,但我再次預計,這將成為我們未來看到的主導行為,以便患者有最佳機會獲得我們在研究中看到的結果。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Maybe let me ask a couple of comments. As it relates to an HER2 induction versus maintenance, I mean, of course, everybody can always speculate all sorts of things. But in the end, medical practice has to be learned by data. So you can speculate. It's a useful hypothesis, but then you have to test it with the clinical trial until you have data, it's a little bit dangerous, I think, to speculate patients lives depend on those treatments and doctors should really stick to the data.

    也許我可以問一些評論。至於 HER2 誘導與維持治療,我的意思是,當然,每個人都可以推測各種各樣的事情。但最終,醫療實踐必須透過數據來學習。所以你可以推測。這是一個有用的假設,但你必須透過臨床試驗來檢驗它,直到你獲得數據,我認為推測病人的生命依賴這些治療有點危險,醫生應該真正堅持數據。

  • The other comment I would want to make is maybe take advantage of the Imfinzi question is I personally think that because there are so many indications that are developed for Imfinzi new indications, some of them are smaller, some others are bigger.

    我想提出的另一個評論是,也許可以利用 Imfinzi 的問題,我個人認為,由於為 Imfinzi 新適應症開發的適應症太多,有些適應症較小,有些則較大。

  • Overall, it looks like Imfinzi has been a little bit -- the potential of Imfinzi has been a little bit underestimated maybe because possibly it's difficult to forecast all those indications. But if you look at the first half, I mean, Imfinzi grew 21% -- and for the second quarter alone, we had a growth of 26%. And if you look at our top products, of course, Road is still leading the race with Farxiga, Tagrisso is the #2, but Imfinzi is our #3 product. So it's a very large product, very important product for us. And of course, for patients so I think it's important to really sort of consider all those smaller indications that collectively will actually fuel the growth of this important product.

    總體而言,Imfinzi 的潛力似乎有點被低估了,可能是因為可能很難預測所有這些跡象。但如果你看一下上半年,我的意思是,Imfinzi 成長了 21%——僅在第二季度,我們的成長就達到了 26%。如果你看看我們的頂級產品,當然,Road 仍然憑藉 Farxiga 領先,Tagrisso 排名第二,但 Imfinzi 是我們排名第三的產品。所以這對我們來說是一個非常大、非常重要的產品。當然,對於患者來說,我認為真正考慮所有這些較小的適應症非常重要,這些適應症共同作用實際上將推動這項重要產品的成長。

  • Gonzalo Artiach, Danske Bank.

    丹麥銀行的 Gonzalo Artiach。

  • Gonzalo Artiach Castanon - Analyst

    Gonzalo Artiach Castanon - Analyst

  • Hello and thank you for taking my questions. The first one I want to ask is on tozorakimab on the COPD program with readouts coming in 2023. We recently saw astegolimab and itepekimab from Roche and Sanofi reporting somewhat mixed data in COPD putting some questions around the IL-33 pathway in COPD. So I was wondering if you could give us some words on your view on tozorakimab given the recent events in the pace? And my second question is on (inaudible) as Marc mentioned, you recently reported that the program did not meet primary endpoint, but there is a stub group, which is see positive outcomes. I was wondering if you could expand a bit on that on who are these patients and how big this population is and give us some flavor on what is in your eyes, the likelihood of FDA approval for this subset of patients with data you have now. Thank you very much.

    您好,感謝您回答我的問題。我想問的第一個問題是關於 COPD 專案中的 tozorakimab 的問題,結果將於 2023 年公佈。我們最近看到羅氏和賽諾菲的 Astegolimab 和 Itepekimab 報告了 COPD 方面的混合數據,並對 COPD 中的 IL-33 路徑提出了一些疑問。所以我想知道,鑑於最近發生的事件,您是否可以談談您對 tozorakimab 的看法?我的第二個問題是(聽不清楚),正如馬克提到的,您最近報告說該計劃沒有達到主要終點,但有一個存根組,看到了積極的結果。我想知道您是否可以稍微詳細說明一下這些患者是誰以及這個群體的規模有多大,並根據您目前掌握的數據,告訴我們您認為 FDA 批准這部分患者的可能性有多大。非常感謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Gonzalo. So Sharon, do you want to take the first one, and Marc will take the second one.

    謝謝,貢薩洛。那麼 Sharon,你想選第一個嗎? Marc 選第二個。

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

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Sure. So about your question regarding tozorakimab and I will say broadly that not all molecules are the same. And we believe that we have a differentiated profile in tozorakimab as our IL-33 monoclonal antibody. One of the features that differentiates tozorakimab is that it can inhibit signaling through both the ST2 pathway as well as the RAGE/EGFR pathway. And we think that's incredibly important in COPD because RAGE/EGFR helps drive epithelial remodeling and mucus production.

    當然。關於您關於 tozorakimab 的問題,我可以概括地說,並非所有分子都是相同的。我們相信,tozorakimab 作為我們的 IL-33 單株抗體具有差異化的特性。Tozorakimab 的其中一個差異特徵是它可以抑制透過 ST2 路徑和 RAGE/EGFR 路徑的訊號傳導。我們認為這對 COPD 來說非常重要,因為 RAGE/EGFR 有助於推動上皮重塑和黏液產生。

  • We know that's important because mucus is driving exacerbations and exacerbations are driving mucus production. Remember that we had a Phase II study front here 4, which is a small proof-of-concept study in patients with COPD recruited irrespective of blood eosinophil count. And we saw a clinical benefit in lung function and reduced risk of COPD worsening in both current and former smokers. We look forward to the readout of the LUNAR program next year, and that includes the (inaudible) trials for tozorakimab.

    我們知道這很重要,因為黏液會導致病情惡化,而病情惡化會導致黏液產生。請記住,我們在這裡進行了一項 II 期研究 4,這是一項針對 COPD 患者的小型概念驗證研究,無論患者血液嗜酸性粒細胞計數如何。我們發現,無論是現在吸菸者還是以前吸菸者,其肺功能均得到了臨床改善,並且 COPD 惡化的風險也降低了。我們期待明年 LUNAR 計畫的成果,其中包括 tozorakimab 的(聽不清楚)試驗。

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

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

  • On selemumab. So let me remind you that we conducted 2 clinical studies, Phase III clinical studies in Mayo Stage II to 1 in 3 and 1 in 3 the both studies were an add-on to plasma cell discretes, seaboard, but also daratumumab was possible. And the third remark I would like to make this -- obviously, this condition is very severe with a fat with fatality and severe mobility. Now to answer your question more directly, about this prespecified subgroup. I'm not going to comment further today.

    使用塞來木單抗。因此,讓我提醒您,我們進行了 2 項臨床研究,即在 Mayo 進行的 III 期臨床研究,II 期研究為 1/3,1/3 的研究為 1/3,這兩項研究都是對血漿細胞離散體的補充,seaboard,但 daratumumab 也是可能的。我想說的第三點是──顯然,這種情況非常嚴重,會導致死亡,並且嚴重影響行動能力。現在更直接地回答您的問題,關於這個預先指定的子群組。我今天不會發表進一步的評論。

  • But I can only say that this is a sizable minority and the clinical benefit that we have seen is very meaningful.

    但我只能說,這只是相當一部分人,而且我們所看到的臨床益處非常有意義。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Sachin, Bank of America.

    薩欽,美國銀行。

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • Hi there, thanks for taking my questions. And one on on respiratory, if that was okay. So firstly, on data of (inaudible), any color on timing over (inaudible) the question is how do you see the probability of those 2 studies. I think investors have been more cautious on X7 given PD-L1 cost of on life (inaudible) and then the second question was just going back to the prior 1 on too. So (inaudible) and the Phase II data. But I wondered if you've looked at the event rates you're seeing within that study and any ability to change here given that's been the issue that both the competitors have had? Thank you.

    您好,感謝您回答我的問題。如果可以的話,還有一個關於呼吸的問題。因此,首先,關於(聽不清楚)的數據,關於時間的任何顏色(聽不清楚),問題是您如何看待這兩項研究的機率。我認為,考慮到 PD-L1 的壽命成本(聽不清楚),投資人對 X7 更加謹慎,第二個問題也只是回到前一個問題。所以(聽不清楚)和第二階段的數據。但我想知道您是否研究過您在該研究中看到的事件發生率,以及是否有能力進行改變,因為這是兩個競爭對手都遇到的問題?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Sean, do you want to start with the second one and then maybe Susan you'll take the [AVANZAR] one.

    肖恩,你想從第二個開始嗎?然後蘇珊,你可能會選擇 [AVANZAR] 這個。

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

    Sharon Barr - Executive Vice President - BioPharmaceuticals R&D

  • Sure. So I'll continue with the topic of tozorakimab. We won't comment on event rates in our ongoing studies. I am aware that some of the other companies noted that they saw a slowing of events during COVID-19. We can't comment on the ongoing study.

    當然。因此我將繼續討論 tozorakimab 這個主題。我們不會對正在進行的研究中事件的發生率發表評論。我知道其他一些公司也指出,在新冠疫情期間,他們的業務有所放緩。我們無法對正在進行的研究發表評論。

  • But as I mentioned earlier, we remain very positive about the potential for tozorakimab to become a new medicine for patients with COPD. We're drilling that based on the encouraging incomes from our Fund Tier 4 studies and we continue to move forward recruiting at pace for our program. And so I look forward to that readout next year.

    但正如我之前提到的,我們仍然非常看好 Tozorakimab 成為 COPD 患者新藥的潛力。我們正在根據基金四級研究的令人鼓舞的收入進行鑽研,並將繼續按計劃推進招募工作。因此我期待明年的宣讀。

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

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

  • And so thanks for the question on (inaudible). Obviously, but the (inaudible) study, given it's also a first-line study and you might expect that the event rates for AVANZAR are going to be reflected in event rates generally across the first-line studies for the combinations of data plus I/O -- so we'll have to wait and see. I mean, I would just comment that AVANZAR completed accrual at an earlier time point. So that's one piece just worth bearing in mind. And I think as well, the learnings that we've had across the program from a biomarker perspective, we're looking to see how we can think about how those might be used across the program for (inaudible) as well.

    謝謝你的提問(聽不清楚)。顯然,但是(聽不清楚)研究,鑑於這也是一項一線研究,您可能預計 AVANZAR 的事件發生率將反映在數據加 I/O 組合的一線研究中的事件發生率中 - 所以我們只能拭目以待。我的意思是,我只是想評論一下 AVANZAR 在較早的時間點完成了累積。所以這是值得牢記的一點。而且我認為,從生物標誌物的角度來看,我們在整個計劃中所獲得的經驗教訓,我們也在考慮如何將這些經驗教訓應用於整個計劃(聽不清楚)。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Suzanne.

    謝謝你,蘇珊娜。

  • Seamus, Guggenheim time.

    謝默斯,古根漢時間。

  • Seamus Fernandez - Equity Analyst

    Seamus Fernandez - Equity Analyst

  • So 2 questions very quickly. So Dave, I think historically, when we talked about the opportunity for Enhertu the numbers that we could comfortably get to in our own models, we're north of $10 billion, especially considering the success that we've seen within Enhertu so far. Can you just help us understand a little bit the path to numbers north of or at $10 billion for this opportunity. I think it's also starting to show through a little bit that AstraZeneca's own market performance in some of the direct reported markets is actually outperforming perhaps what we may have assumed in partner markets. So just trying to get a better understanding of the future of Enhertu as we look at the overall growth trajectory.

    所以很快就有兩個問題。所以戴夫,我認為從歷史上看,當我們談論 Enhertu 的機會時,我們可以輕鬆地在我們自己的模型中獲得的數字是 100 億美元以上,特別是考慮到我們迄今為止在 Enhertu 中看到的成功。您能否幫助我們稍微了解一下這一機會實現 100 億美元以上或達到 100 億美元的途徑?我認為,這也開始逐漸顯現出,阿斯特捷利康在一些直接報告市場中的自身市場表現實際上可能優於我們在合作夥伴市場中假設的表現。因此,當我們觀察整體成長軌跡時,我們試圖更好地了解 Enhertu 的未來。

  • And then just the second question, as we think about the opportunity in cardiovascular disease, PASCAL, we've really seen opportunities emerge from AstraZeneca over time in several categories where you were either third to market or came on very strong from a fourth or third to market position and ultimately became the third or second largest product in category, Imfinzi being a great example. What do you see as the opportunity in obesity for AstraZeneca's existing product portfolio in that context, particularly as some of the large, very established second players seem to be stumbling.

    然後是第二個問題,當我們思考心血管疾病領域的機會時,PASCAL,我們確實看到阿斯特捷利康在幾個類別中隨著時間的推移出現了機會,在這些類別中,您要么是市場第三名,要么從市場第四名或第三名的位置強勢崛起,最終成為該類別中第三大或第二大產品,Imfinzi 就是一個很好的例子。在此背景下,您認為阿斯特捷利康現有的產品組合在肥胖症領域有何機會,尤其是當一些大型、成熟的二級市場參與者似乎正步履蹣跚的時候。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks. Dave, do you want to take the first one?

    謝謝。戴夫,你想坐第一個嗎?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Yes, it would be my pleasure. So Seamus, let me start just first with. One of the really important dynamics that we've seen on Enhertu globally across regions within 2025. At the end of last year, we were commenting that 6 coming online in CCN inclusion and guidelines was going to be an important catalyst along with DB09, DB11 towards really reinvigorating growth beyond what we had seen so far with '03. And I'm really pleased that we've seen strong sequential growth, not only in Q1 but also continuing into Q2.

    是的,我很樂意。那麼 Seamus,首先讓我先說一下。我們在 2025 年內看到的 Enhertu 全球各個地區真正重要的動態之一。去年年底,我們曾評論說,CCN 納入和指南中的 6 將與 DB09、DB11 一起成為重要的催化劑,真正推動成長,超越我們迄今為止在 '03 中看到的水平。我很高興地看到,我們不僅在第一季實現了強勁的連續成長,而且這種成長也持續到了第二季。

  • And I think that, that's double-digit sequential growth that we're seeing on Enhertu is coming as a result of really driving across the various growth opportunities that we've got within the marketplace.

    我認為,Enhertu 實現的兩位數連續成長是我們真正抓住了市場中各種成長機會的結果。

  • So within the U.S. specifically, we see DBO 6 driving launch growth along with contributions coming from the tumor-agnostic label as well as DB within Europe, we're seeing DBO growth along with continued opportunities as we're making inroads into the HER2 low. And then again, the progress that we're making and really driven by China in no small part, I think, has been really, really very, very encouraging to see. So if we take a look at the opportunity for Enhertu in terms of where could we get to if we imagine at peak, I think that we can very much see that we'll see contribution across regions and then in addition to that, I think that DB-09 represents a very, very important opportunity to move into the frontline setting, as Susan mentioned in her comments, there are many patients who don't get an opportunity to be able to see a treatment in the second line.

    因此,具體來說,在美國,我們看到 DBO 6 推動了發布增長,同時來自腫瘤不可知標籤以及歐洲 DB 的貢獻,我們看到 DBO 增長以及持續的機會,因為我們正在進軍 HER2 低位。而且,我認為,我們所取得的進展在很大程度上是由中國推動的,這真的非常非常令人鼓舞。因此,如果我們從巔峰狀態來看 Enhertu 的機會,我認為我們可以清楚地看到,我們將看到跨地區的貢獻,除此之外,我認為 DB-09 代表著進入一線環境的一個非常非常重要的機會,正如蘇珊在她的評論中提到的那樣,許多患者沒有機會在第二線接受治療。

  • So there are more patients available in the front line. And that's why DB09 represents an important growth opportunity above and beyond what we've been able to achieve with those 3, of course, also the duration of therapy is something that we would expect to be longer. 11 and 05 together represent near blockbuster opportunities as we move into the early setting. And there's still clearly a lot more opportunity that we've got to move forward in the ultralow segment for the successes that we've had in DBO6, Seamus, ultra-low remains a place where we still have opportunity for continued progress, and I expect that we'll be able to make that. And then finally, we see combinations as part of the future, combinations with our novel IO bispecifics being an opportunity for growth down the road.

    因此,前線可以接收更多的病人。這就是為什麼 DB09 代表著一個重要的成長機會,它超越了我們透過這 3 個計畫所取得的成就,當然,我們也期望治療的持續時間更長。隨著我們進入早期階段,11 和 05 共同代表著近乎轟動的機會。鑑於我們在 DBO6 中取得的成功,我們顯然在超低端市場還有很大的發展機會,Seamus,超低端仍然是我們繼續取得進步的機會,我希望我們能夠做到這一點。最後,我們將組合視為未來的一部分,與我們新穎的 IO 雙特異性的組合是未來成長的機會。

  • So Enhertu is really delivering nicely against our vision to be able to be one of the largest medicines in our portfolio.

    因此,Enhertu 確實很好地實現了我們的願景,成為我們產品組合中最大的藥物之一。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, David. So your second question, Seamus, it's a great question actually, because it gives me a chance to recognize the incredibly talented team we have in this company not only commercially, I mean, the commercial teams around the world are really absolutely exceptional. You've just mentioned yourself that Enhertu is doing better than you expected, and David and his team are doing an incredibly good job everywhere. Ruud and his team are doing a great job, same in rare disease. So if we now look at your specific question, one aspect is really the quality, the talented teams we have in every geography, and quite frankly, it's taken us 10 years to build the team we have today in every country because it's not that simple.

    謝謝,大衛。所以你的第二個問題,西莫斯,這實際上是一個很好的問題,因為它讓我有機會認識到我們公司擁有的才華橫溢的團隊,不僅在商業方面,我的意思是,世界各地的商業團隊都非常出色。您剛才提到,Enhertu 的表現超出了您的預期,而且 David 和他的團隊在各方面都做得非常出色。魯德和他的團隊做得非常出色,在罕見疾病領域也是如此。因此,如果我們現在看一下您的具體問題,一個方面實際上是質量,我們在每個地區都擁有才華橫溢的團隊,坦率地說,我們花了 10 年時間才在每個國家建立起今天這樣的團隊,因為事情並不是那麼簡單。

  • So that's number one.

    這是第一點。

  • Number 2 is we have a tremendous footprint and (inaudible) is, of course, we follow the science, but it's also that we bring our medicines to as many patients as possible around the world. And so that means the emerging markets, that means China, that means every single country around the world. We want to bring our medicines to those people. And we should remember that many more people living outside the U.S. and Europe than inside those 2 important geographies.

    第二,我們擁有巨大的影響力,(聽不清楚)當然,我們遵循科學,但我們也將我們的藥物帶給全世界盡可能多的患者。這意味著新興市場、中國、世界上每一個國家。我們希望將我們的藥物帶給這些人。我們應該記住,生活在美國和歐洲以外的人比生活在這兩個重要地區的人數多得多。

  • And if you look at Farxiga, it's a good marker of this a great majority of our sales is these days, they come from countries that are not the U.S. U.S. is very, very important, of course, but still as soon as you have a medicine that is affordable, easy to take like an oral (inaudible) and then you can reach out to the millions -- hundreds of millions of people around the world who need our medicine.

    如果你看一下 Farxiga,它就是一個很好的標誌,我們現在的絕大部分銷售來自美國以外的國家。當然,美國非常非常重要,但只要你有一種價格合理、易於服用的藥物,例如口服(聽不清楚),那麼你就可以接觸到全世界數百萬——數億需要我們藥物的人。

  • So the talent, the footprint, the way we develop those products, I think we always try to be innovative and eurolagent is a different route, of course, compared to an injectable. It would be easier, cheaper, but also our clinical development programs. We leverage the combinations, people who suffer from obesity. And I hate this water base it actually because at the end of the day, what it is about is abdominal central, what you call central visit. I mean, in fact, you can be someone who don't necessarily local is, but you have you have central fat, you have abdominal fat.

    因此,我認為,無論是人才、足跡或我們開發這些產品的方式,我們都在不斷嘗試創新,當然,與注射劑相比,Eurolagent 是一種不同的途徑。這會更容易、更便宜,而且我們的臨床開發計畫也會更容易。我們利用這些組合來幫助那些患有肥胖症的人。而我實際上討厭這種水基,因為歸根結底,它是關於腹部中心的,即所謂的中心訪問。我的意思是,事實上,你可能不是一個局部肥胖的人,但你有中心脂肪,有腹部脂肪。

  • And abdominal fat is really what drives insulin resistance, inflammation and all the secondary considerations that you can think about -- so then these people typically -- they suffer from other complications, hypertension, cholesterol, dyslipidemia, kidney disease, et cetera.

    腹部脂肪才是導致胰島素抗性、發炎和所有你能想到的次要因素的真正原因——因此這些人通常會患有其他併發症,如高血壓、膽固醇、血脂異常、腎臟疾病等。

  • So we really try to look at -- how do we address all the components of this metabolic syndrome by combining our products. So our offering will be not only an oral agent, but it's also going to be combinations and addressing all the risk factors -- so we -- what we try to focus on is less the sort of what you might call the cosmetic or base market, which is a consideration for some people. But we believe the most important piece is really central fat and they insulin resistance and all the consequences of this -- but I'd also like to ask Ruud maybe to tell us a little bit about what we're going to do with the cardiometabolic franchise.

    因此,我們確實嘗試研究如何透過結合我們的產品來解決這種代謝症候群的所有成分。因此,我們提供的不僅僅是口服藥物,而且還將提供組合藥物並解決所有風險因素 - 所以我們 - 我們試圖關注的不是所謂的化妝品或基礎市場,這是一些人的考慮因素。但我們認為最重要的部分是真正的中心脂肪和胰島素抗性以及由此產生的所有後果——但我還想請魯德告訴我們一些我們將如何處理心臟代謝特許經營權。

  • Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - BioPharmaceuticals Business Unit

  • Yes, Pascal. And I think if summarized it quite well. We truly believe we have a differentiated strategy here. We have a long heritage, as you already mentioned, in this disease area. There's a deep understanding from a science perspective.

    是的,帕斯卡。我認為總結得相當好。我們確實相信我們有一個差異化的策略。正如您所提到的,我們在這個疾病領域有著悠久的歷史。從科學角度來看,有很深刻的理解。

  • And I dare to say we have excellent relationships across the world with top cardiologists, internal medicine physicians. And I think the combination and the different mechanism of action is a true differentiator. There are so many people who are overweight and have very serious risk factors like the ones you mentioned. And the fact that we have in our portfolio, I think a quite unique oral PCSK9. Sharon discussed the potential of paxostat.

    我敢說我們與世界各地的頂尖心臟病專家、內科醫生保持著良好的關係。我認為組合和不同的作用機制才是真正的差異。有很多人體重超標,並且有您提到的非常嚴重的風險因素。事實上,我認為我們的產品組合中有一個非常獨特的口服 PCSK9。Sharon 討論了 paxostat 的潛力。

  • We discussed our own SGLT2 Farxiga, but also means that if everything works and the oral GLP-1 let's say, is in medicine. It's relatively easy to combine it.

    我們討論了我們自己的 SGLT2 Farxiga,但也意味著如果一切正常並且口服 GLP-1 可以說是藥物。將其組合起來相對容易。

  • And it will also be then easily accessible for so many people around the world. So I think it's a truly differentiated strategy -- we are committed to it. We are investing in a lot of, let's say, resources money into it because we truly believe that we can change the trajectory of so many people around the world with cardiovascular and renal diseases.

    屆時,世界各地的許多人都可以輕鬆訪問它。所以我認為這是一種真正差異化的策略——我們致力於此。我們投入了大量的資源資金,因為我們堅信我們可以改變全世界許多心血管和腎臟疾病患者的命運。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Peter Verdult, BNP Paribas.

    法國巴黎銀行的 Peter Verdult。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Fill your board asking this question, but latest thoughts on tariff dynamics and where expectations or your recommendations sit and what the current administration is picking up with respect to Part B and/or reforms. Secondly, just to Sharon, on Baxter and the C5 data, I realize you can't go into any sort of quantification, but there are data sets from competitors out there. So can I push you on how the data stacks up in your view? Is it the overall profile of efficacy, safety and convenience or can we dream that there is super efficacy on either asset. And then lastly, I hate to mind just the third one, shown up scale just because most people on the call today are probably hopped over from Novo's profit warning call earlier.

    向您的董事會提出這個問題,但請詢問有關關稅動態的最新想法以及預期或建議,以及現任政府在 B 部分和/或改革方面正在採取的措施。其次,對於 Sharon,關於 Baxter 和 C5 數據,我知道您無法進行任何形式的量化,但那裡有來自競爭對手的數據集。那麼我可以向您詢問一下您認為數據如何堆積起來的嗎?它是功效、安全性和便利性的整體概況,還是我們可以夢想任何一項資產都具有超強功效。最後,我不想介意第三個,只是顯示規模,因為今天電話會議上的大多數人可能都是早些時候從 Novo 的盈利預警電話會議中跳出來的。

  • You've got a clear strategy (inaudible) not going to play out until next decade. But it's likely that investors are going to increasingly question obesity market value expectations going forward. So I can just confirm that when you think about future pricing into the materially lower level than the current GLP-1 price. Thank you.

    你有一個明確的策略(聽不清楚),這個策略要到下一個十年才會實施。但投資人未來可能會越來越質疑肥胖市場的價值預期。因此,當您考慮未來定價時,我可以確認這一點,該定價將明顯低於當前的 GLP-1 價格。謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Peter. So I had the word board at the beginning. I'm not sure if I captured your question. I think your question was about tariffs and also MFN. So maybe Aradhana you want to take that one?

    謝謝你,彼得。所以我一開始就有了單字板。我不確定我是否理解了你的問題。我認為您的問題是關於關稅和最惠國待遇的。那麼 Aradhana,也許你想選擇那個?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Sure. So I think your question was whether the tariffs that we expected are in line. Clearly, the tariffs between U.S. and Europe have been announced. I think it still is a question of timing and what happens with the administration when they get implemented, et cetera.

    當然。所以我認為你的問題是我們預期的關稅是否符合。顯然,美國和歐洲之間的關稅已經公佈。我認為這仍然是一個時間問題,以及實施後政府將採取什麼措施等等。

  • We had mentioned on our first quarter call that we have pretty good and segregated supply chains. And therefore, there's only a handful of products where we do import some products from Europe into the U.S. We do already have capacity for those products in the U.S., and we've already started some of the tech transfers, which obviously will take a little bit of time but we will not be significantly impacted by tariffs.

    我們在第一季的電話會議上提到,我們擁有相當良好且獨立的供應鏈。因此,我們確實只從歐洲進口少數幾種產品到美國。我們在美國已經具備這些產品的生產能力,並且已經開始了一些技術轉讓,這顯然需要一點時間,但我們不會受到關稅的重大影響。

  • We reconfirmed the guidance this year. And this year, obviously, we're managing through inventory and so forth, but any impact even if there is, is going to be very short lived since we've already started the tech transfer process.

    我們今年再次確認了這項指導。今年,顯然我們正在透過庫存等方式進行管理,但即使有任何影響,也將是非常短暫的,因為我們已經開始了技術轉移過程。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you.

    謝謝。

  • On the MFN, maybe I can take this one. And we've had, as you can imagine, many interactions with the administration at different levels the industry has had other companies and we, as a company, have had several interactions that (inaudible) personally had many interactions. And we've basically shared what we think could be done because I do believe a rebalancing equalization, if you want to call it this way of pricing or rebalancing of pricing around the world is necessary. The U.S. can no longer pay for the R&D for the world.

    關於最惠國待遇,也許我可以接受這個。你可以想像,我們與不同層級的管理層有過多次互動,這個行業還有其他公司,而我們作為一家公司,也曾有過多次互動,我們個人也曾有過多次互動。我們基本上分享了我們認為可以做的事情,因為我確實相信重新平衡均等化(如果你想稱之為這種定價方式)或重新平衡全球定價是必要的。美國已無力負擔全世界的研發費用。

  • I mean it's not sustainable. So we need to have a fair sharing of the cost of R&D in our industry across which countries. And of course, for our countries, we need to be more flexible with price, but which countries need to share and then share and you have to consider GDP levels, et cetera, for sure.

    我的意思是這是不可持續的。因此,我們需要在各國之間公平分擔我們產業的研發成本。當然,對於我們國家來說,我們需要在價格方面更加靈活,但哪些國家需要共享,然後共享,你肯定要考慮 GDP 水平等等。

  • So we've actually made a number of proposals. Of course, as you know, the pricing structure in the U.S. and the U.S. market is a huge market. It's a complicated market.

    所以我們實際上已經提出了一些建議。當然,如你所知,美國的定價結構和美國市場是一個巨大的市場。這是一個複雜的市場。

  • Pricing is very complicated. So there's a lot of technicalities involved but we did make our proposals, which we believe could achieve what the President is trying to achieve, but we also need our hub to increase their share of GDP allocated to innovative pharmaceuticals. I mean if you think about it, today, the U.S. spends 0.8% of GDP in innovative pharmaceuticals, 0.8%. The U.K. and many countries in Europe, Germany is better, but many countries in Europe spent 0.3% of GDP. That's not enough. They need to increase it. And actually increasing it would be good not only for patients because we talk about price, but it's not only a question of price question of access.

    定價非常複雜。因此,這涉及許多技術細節,但我們確實提出了建議,我們相信這些建議可以實現總統想要實現的目標,但我們也需要我們的中心增加分配給創新藥物的 GDP 份額。我的意思是,如果你想想,今天,美國在創新藥物上的支出佔 GDP 的 0.8%,0.8%。英國和歐洲很多國家,德國比較好一些,但是歐洲很多國家都花了GDP的0.3%。這還不夠。他們需要增加它。實際上,提高價格不僅對患者有好處,因為我們談論的是價格,但這不僅僅是價格問題,還是獲取問題。

  • In many countries in Europe, people or patients wait for years to get access to medicines that could save their lives. So it's a question of access, not only price. The second reason that would be good for Europe is we believe our sector is a great sector in terms of science, innovation, creating jobs and economic value. So to innovation -- I mean, I started in the industry a long time ago. And at the time, innovation was driven out of Europe, when we were selling peels really.

    在歐洲許多國家,人們或病人必須等待數年才能獲得可以挽救他們生命的藥物。因此,這是一個獲取途徑的問題,而不僅僅是價格的問題。對歐洲有利的第二個原因是,我們相信我們的產業在科學、創新、創造就業機會和經濟價值方面是一個很棒的產業。所以對於創新——我的意思是,我很久以前就開始進入這個行業了。當時,當我們真正銷售果皮時,創新被趕出了歐洲。

  • Today, innovation is driven out of the U.S. There is an explosion of technologies, as you know, that is driven by all these investments that has taken place.

    如今,創新被趕出了美國。如你所知,科技的爆炸性成長是由所有這些投資所推動的。

  • China is ramping up, as we've talked about before, very rapidly. And sadly, Europe is falling behind. So I think this rebalancing needs to take place, not only for the industry, but also and not only for the U.S. pricing level, but also so that Europe can actually contribute to this innovation and then benefit from it in terms of value creation and economic development. But the administration is considering all these things, and we'll see what comes out of all these proposals that different companies may have made.

    正如我們之前談到的,中國正在迅速發展。可悲的是,歐洲正在落後。因此,我認為需要進行這種重新平衡,不僅是為了產業,也是為了美國的定價水平,歐洲也可以真正為這種創新做出貢獻,然後在價值創造和經濟發展方面從中受益。但政府正在考慮所有這些事情,我們將看看不同公司提出的所有這些建議會產生什麼結果。

  • On the (inaudible) data, I'll ask Marc to comment. But I want to make a quick comment. We really want to be respectful of congresses and data presented at the Congress. We don't want to disclose data ahead of the Congress because we want to be respectful of the processes that are in place and the right of congress to keep the data until it's presented.

    關於(聽不清楚)數據,我會請馬克發表評論。但我想簡單發表一下評論。我們確實希望尊重大會和大會上提出的數據。我們不想在國會召開之前披露數據,因為我們希望尊重現有的程序以及國會在數據提交之前保留數據的權利。

  • But maybe, Marc, in a minute wants to make a few points. The last point I will make about the so-called obesity. I've never really liked, as I said, the award obesity for me, it's about weight management because actually, at the end of the day, for me, it's not about how you look. I mean you look the way you want to look quite frankly. The question is how much abdominal fat do you have?

    但馬克,也許一會兒他想提出幾點意見。我最後要談的一點是有關所謂的肥胖。正如我所說,我從來都不喜歡肥胖獎,對我來說,它是關於體重管理的,因為實際上,對我來說,歸根結底,它與你的外表無關。我的意思是坦白說,你看起來就像你想要的樣子。問題是您的腹部脂肪有多少?

  • And how much inflammation do you create around your lever, around your pancreas or on your heart, in your body and how much that drives multiple conditions, in particular, metabolic conditions. So our approach has always been to target this Central is dominated the -- I mean, metabolic syndrome is not the right term because it's never been a recognized indication, but let's say, this insulin resistance. And that's really what we target.

    您的肝臟、胰臟或心臟周圍以及您的身體內會產生多少發炎?這會在多大程度上引發多種疾病,特別是代謝疾病?因此,我們的方法一直是針對這個中心主導的——我的意思是,代謝症候群並不是正確的術語,因為它從來都不是一個公認的指徵,而是說,這種胰島素抗性。這確實就是我們的目標。

  • We believe it's a big market. We believe it's a market that needs to be addressed with prices that are affordable. And then payers and patients around the world should benefit and then it should be reimbursed because if you address that, you're going to really help patients. But at the end of the day, these are chronic treatments. And essentially, you have to be easy to take and you have to be affordable, so people can take these medicines for a long time.

    我們相信這是一個巨大的市場。我們相信這是一個需要以可負擔的價格來滿足的市場。然後,世界各地的付款人和患者都應該受益,然後應該得到報銷,因為如果你解決了這個問題,你就會真正幫助病人。但歸根究底,這些都是慢性治療。本質上,藥物必須易於服用,價格也必須便宜,這樣人們才可以長期服用這些藥物。

  • Sorry to talk a little bit long, but Marc, over to you for the C5 data.

    抱歉說得有點長,但是馬克,C5 數據交給你了。

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

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

  • As you advised Pascal, I'm not going to be able to talk about detailed data. What I can say on top of what I've expressed in my prepared remarks is that the rapid onset in patient reported outcome is going to be a strong point of this gefurulimab. And overall, for our C5 franchise, I think it will be a very good -- will complete the injectable franchise, infusion franchise that we have with Ultomiris and Soliris in (inaudible). So we see it as a complementary product in addition to the strong franchise that we have today. Thank you.

    正如你建議帕斯卡的那樣,我無法談論詳細的數據。除了我在準備好的演講中表達的內容之外,我還能說的是,病患報告結果的快速起效將是這款吉芙瑞單抗的一大優勢。總體而言,對於我們的 C5 特許經營權,我認為這將是一個非常好的 - 將完成我們與 Ultomiris 和 Soliris 共同擁有的注射劑特許經營權和輸液特許經營權(聽不清楚)。因此,我們將其視為對我們目前擁有的強大特許經營權的補充產品。謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Matthew Weston, UBS.

    瑞銀的馬修·韋斯頓。

  • Matthew Weston - Equity Analyst

    Matthew Weston - Equity Analyst

  • Thank you very much. Two questions, if I can. The first on the C5 franchise. Marc, I'd be very interested to understand the dynamics in the market with the first launch of Soliris biosimilar. Are we seeing any signs of payers in the U.S. or ex U.S. introducing step edits or therapeutic substitution forcing patients back down to biosimilar SOLIRIS away from ULTOMIRIS and then a question for (inaudible) on Barsega BBP. Can you remind us how much of Farxiga is in China? And also, I realize you don't know yet what the potential financial impact is. But in the past, Vasteras previously given guidance on other VBP products suggesting that potentially sometimes there are commercial measures that may offset the impact of VBP.

    非常感謝。如果可以的話,我有兩個問題。C5 系列的第一部作品。馬克,我非常有興趣了解 Soliris 生物相似藥首次上市後的市場動態。我們是否看到任何跡象表明美國或美國以外的付款人引入分步編輯或治療替代,迫使患者從 Ultomiris 轉向生物仿製藥 SOLIRIS,然後詢問 (聽不清楚) 關於 Barsega BBP 的問題。可以提醒我們一下 Farxiga 在中國的銷售量是多少嗎?而且,我知道您還不知道潛在的財務影響是什麼。但過去,韋斯特羅斯曾就其他 VBP 產品給予指導意見,暗示有時可能會採取商業措施來抵消 VBP 的影響。

  • And I just wondered whether that was something that you expected to see here.

    我只是想知道這是否是您希望在這裡看到的東西。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks very much. Marc, do you want to take the first one?

    非常感謝。馬克,你想坐第一個嗎?

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

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

  • To try to address your question, I think the continued progression of Ultomiris and the increasing also conversion from Soliris to Ultomiris, I think, brings part of the answer. So we do not face a sort of a back to biosimilar Soliris from payers. Once the conversion has been established in any given indication or any given market, usually Ultomiris as a very sustainable growth.

    為了嘗試回答您的問題,我認為 Ultomiris 的持續發展以及從 Soliris 到 Ultomiris 的不斷轉變,可以給出部分答案。因此,我們不會面臨付款人轉向生物相似藥 Soliris 的情況。一旦在任何給定的適應症或任何給定的市場中建立了轉換,通常 Ultomiris 就會實現非常永續的成長。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks Marc, I called.

    謝謝馬克,我打過電話了。

  • Unidentified Participant

    Unidentified Participant

  • Thanks for the question. So as you know, Forxiga represent a very important growth driver for our CVRM portfolio in China and both in diabetes as well as in CKD and heart failure indication. As we already communicated and Ruud already mentioned, and we do expect VBP for Forxiga as part of Batch 1 with the impact in the second half of this year. Your question is very right. There are definitely the different implications of the usage of the drugs in a post VBP setup.

    謝謝你的提問。如您所知,Forxiga 是我們在中國的 CVRM 產品組合中非常重要的成長動力,無論是在糖尿病還是 CKD 和心臟衰竭適應症方面。正如我們已經溝通過並且 Ruud 已經提到的那樣,我們確實預計 Forxiga 的 VBP 將作為第 1 批的一部分,並在今年下半年產生影響。你的問題非常正確。在 VBP 後設定中使用藥物肯定會產生不同的意義。

  • And you know that VBP is usually driving much broader utilization and broader access for many more patients and given the unmet need in China, I'm sure the foresee and class will be widely used, which means that in the short period you can anticipate the reduction primarily driven by price. . But equally, you can expect the tail and the potential increase volume driven as we saw in many other brands in the post VBP time in China. So basically, we anticipate very similar trends to the brands like (inaudible), for example, in the past.

    而且您知道 VBP 通常會推動更多患者的廣泛利用和更廣泛的獲取,並且考慮到中國尚未滿足的需求,我相信預見和類別將被廣泛使用,這意味著在短期內您可以預見主要由價格驅動的降價。。但同樣,你可以預期尾部和潛在的銷售成長,正如我們在中國 VBP 之後的許多其他品牌所看到的那樣。因此基本上,我們預期未來會出現與過去(聽不清楚)等品牌非常相似的趨勢。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • And (inaudible), you referred to commercial activities. In fact, it's what we call consumerization in China. To be honest, it's actually very similar to what companies are now considering in the U.S. and they call go direct or direct to consumer. It's essentially selling directly to patients who, of course, receive a prescription.

    並且(聽不清楚),您提到了商業活動。事實上,這就是我們在中國所說的消費化。老實說,這實際上與美國公司現在正在考慮的做法非常相似,他們稱之為直接銷售或直接面向消費者。它本質上是直接向患者銷售,當然患者需要處方。

  • And if you look at Crestor, that's what we have been able to achieve, patients get a script from their doctors. And more and more, they get an electronic script these days for video consultation and then they get their Crestor delivered to their home.

    如果你看一下 Crestor,這就是我們所能夠實現的,患者可以從醫生那裡得到處方。如今,越來越多的人會獲得電子腳本來進行視訊諮詢,然後讓他們將 Crestor 送到家中。

  • And a lot of people prefer to pay $25 or $30. I think it costs delivered to their home rather than go to the hospital in queue to have it for free. So we think we can actually do a similar approach in -- with Farxiga in China. Of course, sales will be lower, but as car said, there will be quite a tail. And actually, quite interestingly, you see in some parts of the U.S., similar behavior, sometimes people can't put up with all the hurdles of getting reimbursed and they decide just to pay out of pocket and be done with it.

    很多人願意支付 25 美元或 30 美元。我認為送貨上門比去醫院排隊免費獲得要貴得多。因此,我們認為我們實際上可以在中國對 Farxiga 採取類似的方法。當然,銷量會較低,但正如汽車所說,尾款會相當多。事實上,非常有趣的是,你會看到在美國的某些地區也有類似的行為,有時人們無法忍受報銷的所有障礙,他們決定自掏腰包,一勞永逸。

  • So if the product is at a price that is affordable and you can get it delivered to your home, of course, you need a script, but it's a convenient option for patients.

    因此,如果產品價格合理,並且可以送貨上門,當然您需要處方,但這對患者來說是一個方便的選擇。

  • Rajan Sharma, Goldman.

    高盛的拉詹·夏爾馬。

  • Rajan Sharma - Analyst

    Rajan Sharma - Analyst

  • Hi, thanks for taking a question. So just on the rare disease side of things. So One of the key cost this year is obviously (inaudible). Could you just help us understand what the target profile is for the drug, particularly in the context of Strensiq in the same setting? What's the residual unmet need there? Thank you.

    你好,謝謝你回答問題。這只是就罕見疾病方面而言。因此,今年的主要成本之一顯然是(聽不清楚)。您能否幫助我們了解該藥物的目標概況,特別是在相同環境下與 Strensiq 的對比?那裡還有哪些未被滿足的需求?謝謝。

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

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

  • So thank you for this question on (inaudible). So first of all, (inaudible) has been developed in both the adult and pediatric indications and our goal is to achieve a much wider geographic coverage than we have with Strensiq. Coverage of Strensiq is strong in a few countries but the access and the reimbursement is -- has been slower in other parts of the world. Now if you look at the 2 products, since alpha will be 1 administration, 1 injection every 2 weeks. And if you compare this to Strensiq, you have either 6 or 12 injection in the same period of 2 weeks.

    謝謝你提出這個問題(聽不清楚)。首先,(聽不清楚) 已經在成人和兒科適應症中得到了開發,我們的目標是實現比 Strensiq 更廣泛的地理覆蓋範圍。Strensiq 在少數國家覆蓋率較高,但在世界其他地區,其取得和報銷速度較慢。現在,如果您看一下這兩種產品,由於 alpha 將是 1 次給藥,每 2 週注射 1 次。如果將其與 Strensiq 進行比較,您會發現在相同的 2 週時間內,您需要注射 6 次或 12 次。

  • So it will have a great patient benefit. As I said earlier on, we will have the results of our Phase III trials towards the end of the year and we look forward to bringing this new terms around the world.

    因此它將給患者帶來極大的益處。正如我之前所說,我們將在今年年底前獲得第三階段試驗的結果,我們期待將這項新條款推廣到世界各地。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Michael Leuchten, Jefferies.

    傑富瑞 (Jefferies) 的麥可‧洛伊希滕 (Michael Leuchten)。

  • Michael Leuchten - Analyst

    Michael Leuchten - Analyst

  • Thank you for taking the question. Quick question on the Part D redesign, please. One of your European competitors talked about how the volume uplift in the second quarter was below the expectations and the overall impact from the Part D design, redesign maybe not as hoped, your oncology franchise overall performed very, very strongly in the second quarter. Just wondering if you could talk to, was that despite the part design maybe not having the volume effect? Or did you not see that slower uptake and you're quite happy with what you saw? Thank you.

    感謝您回答這個問題。請問關於 D 部分重新設計的快速提問。你們的一位歐洲競爭對手談到第二季度的銷售成長低於預期,以及 D 部分設計和重新設計的整體影響可能不如預期,但你們的腫瘤學特許經營在第二季度的整體表現非常強勁。只是想知道您是否可以聊聊,儘管零件設計可能沒有體積效果,但這是否正常?或者您沒有看到這種較慢的吸收速度並且對所看到的情況感到滿意?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Dave, I mean, it's really mostly an oncology question. Do you want to cover that?

    戴夫,我的意思是,這實際上主要是一個腫瘤學問題。你想掩蓋這一點嗎?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Yes, it would be my pleasure. So Michael, I commented last quarter that the Part D redesign really was a rebasing event as we saw the gross-to-net impact take place for paying for the offset for the co-pay capping. And we've also talked about how we've seen an offset in addition to that with fewer patients on free drug, lower abandonment rates. And so some of these elements really coming into play to help to offset the additional liability that we face. I also commented that after that rebasing, we would see sequential growth pick up and that we would see growth from there, not only on the existing medicines, but also from new launches.

    是的,我很樂意。邁克爾,我上個季度就評論說,D 部分的重新設計實際上是一個重新調整事件,因為我們看到了支付共同支付上限抵消額所產生的總額對淨額的影響。我們也討論了除此之外我們還看到了一種抵消作用,即免費藥物的患者減少,放棄率降低。因此,其中一些因素確實發揮作用,有助於抵消我們面臨的額外責任。我還評論說,在重新調整基準之後,我們將看到連續增長回升,並且我們將從那裡看到增長,不僅是現有藥物,還有新推出的藥物。

  • . I'm really pleased that we saw that with Calquence and with Tagrisso. So with Calquence, we saw sequential growth of 15% in the United States with Tagrisso, we saw sequential growth of 12%. And in both of those instances, demand was the overwhelming driver of the growth that we saw -- and so as we take a look at the opportunities in front of us, Tagrisso, we're going to continue to drive FLAURA2, which we've been having very nice success with alongside with (inaudible) with Calquence. We look forward to the opportunity to continue to take advantage of the leading share position that we have and moving forward with that and getting ready for the Amplify launch as we move to a finite option.

    。我很高興我們在 Calquence 和 Tagrisso 上看到了這一點。因此,我們看到 Calquence 在美國實現了 15% 的連續成長,而 Tagrisso 則實現了 12% 的連續成長。在這兩種情況下,需求都是我們看到的成長的主要驅動力——因此,當我們審視擺在我們面前的機會時,Tagrisso,我們將繼續推動 FLAURA2,我們與 Calquence 一起取得了非常好的成功。我們期待有機會繼續利用我們擁有的領先份額地位,並在此基礎上繼續前進,為 Amplify 的推出做好準備,因為我們將轉向有限的選擇。

  • So I would say that this is playing out consistent with our expectations and how I believe that we've been talking about it for the last year or so.

    所以我想說,這與我們的預期是一致的,而且我相信我們在過去一年左右一直在談論這個問題。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Dave. We'll take one last question (inaudible) to you, Luisa.

    謝謝,戴夫。路易莎,我們想問您最後一個問題(聽不清楚)。

  • Luisa Hector - Equity Analyst

    Luisa Hector - Equity Analyst

  • Hi, thank you, Pascal. A big picture one, really. So I mean, it's intriguing. The diversification of Astra is very clear, and we've heard a lot of it through the call today. You've also seen an unprecedented number positive trial readouts. But there's still a bit of a leaning towards oncology.

    你好,謝謝你,帕斯卡。確實是一幅大圖。所以我的意思是,這很有趣。阿斯特拉的多樣化非常明顯,我們今天在電話會議上已經聽到了很多。您還看到了前所未有的陽性試驗讀數。但仍有點傾向腫瘤學。

  • I mean great that we now see Imfinzi with so many uses in cancer, potentially on track to be your highest selling drug. So I'm just wondering 2 things really. Has the mix of your 2030 revenue ambition shifted? And how confident are you that you now have the right number of therapy areas at Astra and that your end-to-end pipeline filling is efficient to sustain the company through to the next decade. So I guess it's really where are the gaps that you see given all of the infilling that you have very successfully achieved? Thank you.

    我很高興看到 Imfinzi 在治療癌症方面有如此多的用途,有可能成為最暢銷的藥物。所以我實際上只是想知道兩件事。您對 2030 年收入目標的結構是否改變了?您對於阿斯特拉目前擁有適當數量的治療領域以及端到端管道填充是否高效,是否能夠支撐公司在未來十年內持續發展有多大信心?因此,我想,考慮到您已經非常成功地實現了所有填充,您真正看到的差距在哪裡?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • I'm not -- I suspect, actually, Ruud would take offense of that comment because, I mean, in the first half, if you look at it, oncology was almost $12 billion. 11.95%, and biopharma was 11.2% and still growing. So it is a very important part of our company -- and I think it should not be -- what shouldn't be underestimated is the fact that in the emerging markets, in particular, the foundation of our presence is actually biopharmaceuticals. And it's key because that creates the platform to then launch products in oncology, in rare disease. If you start from very little, it's hard and you don't have the talent in many geographies, I was in the Middle East, South Sasan geographies.

    我並不懷疑——實際上,我懷疑魯德會對這一評論感到不快,因為,我的意思是,如果你看一下上半年,腫瘤學的銷售額接近 120 億美元,佔 11.95%,而生物製藥的銷售額為 11.2%,並且仍在增長。所以這是我們公司非常重要的一部分——我認為不應該這樣——不應低估的事實是,特別是在新興市場,我們存在的基礎實際上是生物製藥。這是關鍵,因為這創建了推出腫瘤學和罕見疾病產品的平台。如果你從零開始,那會很困難,而且你在許多地區都沒有人才,我曾在中東、南薩桑地區工作過。

  • We've been able to build really, really talented people, teams because we've got this presence and we've attracted those people and then on this foundation of biopharmaceuticals, we actually can have oncology, which is really a great opportunity for (inaudible) the emerging markets, but also rare disease where Marc and the team have been driving growth. So that's one aspect.

    我們已經能夠建立真正有才華的人才和團隊,因為我們有這樣的影響力,並且我們吸引了這些人才,然後在生物製藥的基礎上,我們實際上可以擁有腫瘤學,這對於(聽不清楚)新興市場來說真的是一個很好的機會,也是罕見疾病領域,Marc 和團隊一直在推動成長。這是一個方面。

  • The second aspect is if you actually look at the pipeline, there are several medicines that are actually going to drive our future in what we call biopharmaceuticals. In respiratory disease, we have several products I mean those are commercial is growing and the new ones. And in cardiovascular medicine, we have quite a number of products that can be big. I mean an oral PCSK9, if it works the way we hope it will work, has enormous potential around the world. PCSK9 can at great products, but they're injectable, they're kind of expensive outside the U.S., the use is limited.

    第二個方面是,如果你真正看研發管線,你會發現有幾種藥物實際上將推動我們所謂的生物製藥的未來發展。在呼吸系統疾病方面,我們有幾種產品,我的意思是那些商業產品正在成長,而且是新產品。在心血管醫學領域,我們有相當多的產品可以發揮巨大作用。我的意思是,如果口服 PCSK9 能按照我們所希望的方式發揮作用,那麼它在世界範圍內將具有巨大的潛力。PCSK9 可以成為很好的產品,但它們是注射劑,在美國以外地區價格昂貴,用途有限。

  • If you bring an affordable oral agent, you have a huge potential hypertension, huge potential. A lot of people across the world have again, this sort of central fat even though they may not look over weight, they're contain into resistance and they have hypertension, huge potential, same for, of course, the oral group.

    如果你帶一種負擔得起的口服藥物,你就有巨大的潛在高血壓,巨大的潛力。世界上很多人都有這種中心脂肪,儘管他們看起來不超重,但他們有抵抗力,並且患有高血壓,潛力巨大,當然口服組也一樣。

  • So I think over the next few years, if our pipeline delivers the way we are hoping it does, and we started well with Baxter, you'd see a great growth in cardiovascular disease. So as to the point about do we have enough CRP areas, I think, yes. We can always go and explore new things. But the big -- what are the biggest killers in the world. (inaudible) number one.

    因此我認為,在未來幾年內,如果我們的管道能夠按照我們所希望的方式運行,並且我們在百特方面有一個良好的開端,你就會看到心血管疾病的大幅增長。至於我們是否有足夠的 CRP 區域,我認為是的。我們總是可以去探索新事物。但是世界上最大的殺手是什麼呢? (聽不清楚)第一名。

  • Respiratory disease, people forget always that mortality from asthma attacks or COPD attacks is high. And the third is oncology. So we are actually addressing the 3 biggest ones oncology, I mean, oncology, metrology. We are actually addressing the 3 biggest killers in the world. And we'll -- and the science is exploding, not only in oncology, but not in cardiovascular and respiratory disease and immunology.

    呼吸系統疾病,人們總是忘記氣喘發作或慢性阻塞性肺病發作的死亡率很高。第三個是腫瘤學。所以我們其實正在解決三個最大的問題:腫瘤學,腫瘤學,計量學。我們實際上正在解決世界三大殺手問題。而且科學正在蓬勃發展,不僅在腫瘤學領域,而且在心血管疾病、呼吸系統疾病和免疫學領域。

  • So I think we have enough and we are very focused on changing medicines in those areas with new technologies and to grow past 2030. So with this, thank you so much for all your great questions and your interest, and we wish you a great day.

    所以我認為我們已經足夠了,我們非常注重利用新技術來改變這些領域的藥物並實現 2030 年後的成長。因此,非常感謝您提出的所有重要問題和關注,我們祝您度過美好的一天。