AstraZeneca PLC (AZN) 2026 Q1 法說會逐字稿

Good morning to those joining from the UK and the US. Good afternoon to those in Central Europe, and good evening to those listening in Asia. Welcome to AstraZeneca's Q1 2026 webinar for investors and analysts.

早安，英國與美國的各位與會者。中歐的各位午安，亞洲收聽的各位晚安。歡迎參加阿斯特捷利康（AstraZeneca）2026 年第一季投資人與分析師網路研討會。

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.

在我把時間交給阿斯特捷利康之前，我想先宣讀「安全港」聲明。本公司擬適用 1995 年《美國私人證券訴訟改革法》（Private Securities Litigation Reform Act of 1995）的安全港條款。本次電話會議的與會者可能會就阿斯特捷利康的營運與財務表現作出前瞻性陳述。

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.

雖然我們相信自身的預期係基於合理假設，但前瞻性陳述本質上涉及風險與不確定性，且可能受多項因素影響，導致實際結果與這些前瞻性陳述所明示或暗示者出現重大差異。

Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call. The company undertakes no obligation to update forward-looking statements. Please carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation and webcast. (Operator Instructions)

本次電話會議中所作的任何前瞻性陳述，均反映本次會議當時可得的知識與資訊。本公司不承擔更新前瞻性陳述之任何義務。請仔細閱讀隨本簡報與網路直播所附投影片中的前瞻性陳述免責聲明。(接線員指示)

And with that, I'll now hand you over to the company.

那麼，我現在把時間交給公司。

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

誠摯歡迎各位參加阿斯特捷利康 2026 年第一季投資人與分析師簡報電話會議與網路直播。我是投資人關係主管 Joris Silon。在我把時間交給 Pascal 與我們的執行團隊成員之前，我想先說明幾項會議事項。今天所呈現的所有資料皆可於阿斯特捷利康投資人關係網站取得。

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

請看下一張投影片。本投影片包含我們的前瞻性陳述（含安全港條款），建議各位撥冗閱讀。我們將以固定匯率（CER）、核心財務數字及其他非 GAAP 指標來評論我們的表現。非 GAAP 與 GAAP 的電話會議調節表載於本次業績公告中。除非另有說明，所有引用數字單位皆為百萬美元。

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

請看下一張投影片。本投影片顯示今日會議議程。在我們的預備發言後，將開放提問。如同以往，我們會在既定時間內盡可能回答更多問題。但也請各位限制提問數量，讓其他人也能公平參與問答。

And with that, please advance to the next slide. And Pascal, over to you.

那麼，請切換到下一張投影片。Pascal，交給你。

Thank you, Joris, and welcome, everyone. Next slide, please. We delivered a strong first quarter, building on the momentum we generated in 2025. Total revenue grew 8% in the quarter, supported by a robust demand for our innovative medicines. We saw strong growth in operating profit, which increased 12%, reflecting our ongoing focus on operating leverage.

謝謝你，Joris，也歡迎各位。請看下一張投影片。我們第一季表現強勁，延續 2025 年所累積的動能。本季總營收成長 8%，主要受惠於市場對我們創新藥物的強勁需求。營業利益亦大幅成長，增加 12%，反映我們持續聚焦於營運槓桿。

Core EPS grew 5%, our EPS growth was held back by the low tax rate in the prior period. Since our Q4 2025 results, we have secured 14 approvals in major regions across our diverse portfolio a clear illustration of the value our medicines bring to patients globally. Additionally, we continue to see strong delivery from our pipeline.

核心每股盈餘（Core EPS）成長 5%；由於前一期間稅率偏低，抑制了我們的 EPS 成長幅度。自 2025 年第四季業績公布以來，我們在主要地區、涵蓋多元產品組合，已取得 14 項核准，清楚展現我們藥物為全球病患帶來的價值。此外，我們的研發管線仍持續展現強勁交付成果。

In the past weeks, we announced results from four positive Phase 3 programs including two NMEs, tozorakimab and efzimfotase alfa. We continue to invest in our commercial capabilities, both to support ongoing launches and multiple future launches such as baxrostat, Camizestrant and tozarakimab. In R&D, we continue to invest in our pipeline, including our transformative technologies.

在過去幾週，我們公布了四項第三期（Phase 3）計畫的正面結果，其中包含兩項新分子實體（NME）：tozorakimab 與 efzimfotase alfa。我們持續投資商業化能力，以支持既有上市推進與多項未來上市計畫，例如 baxrostat、Camizestrant 與 tozarakimab。在研發方面，我們也持續投資於研發管線，包括具變革性的技術平台。

Please move to the next slide. The breadth of our business remains a competitive strength with a solid growth outlook across therapy areas and key markets. Oncology and Rare Disease saw strong double-digit growth, while high demand in R&I was offset by loss of exclusivity in CVRM. We saw strong performances across our key regions. Our largest market, the United States, grew at a double-digit percentage, benefiting from our investment behind recent launches with Europe and emerging markets growing at high single digits.

請移至下一張投影片。我們業務版圖的廣度仍是競爭優勢，各治療領域與主要市場皆具穩健成長展望。腫瘤與罕見疾病呈現強勁的雙位數成長；而呼吸與免疫（R&I）的高需求，則被心血管、腎臟與代謝（CVRM）領域的專利到期（失去獨占）所部分抵銷。我們在各主要地區均有亮眼表現。我們最大市場美國以雙位數百分比成長，受惠於我們對近期上市產品的投資；歐洲與新興市場則以高個位數成長。

Importantly, we continue to deliver impressive growth in the emerging markets with ex-China revenues up 9%, reflecting the benefit of our sustained presence in this market. Revenues in China increased by 2% with VBP implementation impacting Forxiga, Lynparza and roxadustat growth. We are confident in our growth outlook in China based on the positive 2026 and RDL outcomes.

更重要的是，我們在新興市場持續交出令人印象深刻的成長，除中國以外的新興市場營收成長 9%，反映我們在該市場長期深耕所帶來的效益。中國營收成長 2%，其中 VBP（帶量採購）落地實施影響 Forxiga、Lynparza 與 roxadustat 的成長。基於 2026 年與 RDL 的正面結果，我們對中國的成長展望充滿信心。

Next slide, please. In the third quarter, we saw a continuation of the successful clinical trial delivery seen in 2025. We announced four positive high-value programs, reinforcing the continued progress we are making towards our 2030 ambition and beyond. We look forward to discussing the significant potential of this readout during this call.

請看下一張投影片。在第三季，我們延續了 2025 年所見的臨床試驗高效交付表現。我們公布四項具高價值的正面計畫結果，強化我們朝 2030 年願景及更長遠目標持續推進的進展。我們期待在本次會議中討論這些讀出結果的重大潛力。

And with that, I will hand over to Aradhana to talk you through our financials. Please advance to the next slide.

接下來，我把時間交給 Aradhana，請她帶各位回顧我們的財務表現。請切換到下一張投影片。

Thank you, Pascal, and good morning, and good afternoon, everyone. As usual, I will start with our reported P&L. Next slide, please. As Pascal has already highlighted, we saw very good top line momentum in the first quarter with total revenue increasing by 8%. Product revenue consisting of product sales and alliance revenue also increased 8% with continued growth seen across all key regions. Alliance revenue increased by 26%, reflecting our increased profit shares for our partnered products in HER2 and Tezspire in regions where our partners book product sales.

謝謝你，Pascal，各位早安、午安。如同以往，我將先從我們的申報損益表（reported P&L）開始。請看下一張投影片。如 Pascal 先前所強調，我們第一季營收動能非常良好，總營收成長 8%。由產品銷售與聯盟收入構成的產品收入亦成長 8%，且各主要地區皆持續成長。聯盟收入成長 26%，反映我們在 HER2 相關合作產品以及 Tezspire 上的分潤提高，這些地區由合作夥伴入帳產品銷售。

Next slide, please. This is our core P&L. The core gross margin in Q1 was 83%. For the full year, we continue to anticipate a stable to slightly higher core gross margin versus 2025. Core R&D expenses increased by 8%, driven by continued acceleration and investment in our pipeline. The number of active clinical trials increased by 10% and the number of patients enrolled in our studies increased by 30% compared to Q1 last year as we continue to bring new innovative medicines to patients while creating value for our shareholders.

請看下一張投影片。這是我們的核心損益表（core P&L）。第一季核心毛利率為 83%。就全年而言，我們仍預期核心毛利率相較 2025 年將維持穩定至略為提高。核心研發費用成長 8%，主要由研發管線持續加速推進與投資所帶動。相較去年第一季，進行中的臨床試驗數量增加 10%，研究收案病患數增加 30%；我們持續將新的創新藥物帶給病患，同時為股東創造價值。

As previously highlighted, we continue to invest in transformative technologies, including cell therapies and T cell engagers to drive growth also beyond 2030. As a percentage of total revenue, core R&D costs accounted for 23% in the first quarter. For the full year, we continue to expect core R&D costs to be at the upper end of the low 20s percentage range.

如先前所述，我們持續投資具變革性的技術，包括細胞治療與 T 細胞銜接器（T cell engagers），以推動 2030 年以後的成長。以總營收百分比計，第一季核心研發成本占比為 23%。就全年而言，我們仍預期核心研發成本占比將落在低 20% 區間的上緣。

Core SG&A cost increased by 7% in the first quarter. This was partly driven by prelaunch investments behind baxrostat, which has a US PDUFA date in the second quarter of 2026. As you've seen, we have had a great start to 2026 in terms of R&D with success in four high-value programs, including tozorakimab, which will require SG&A investment to maximize their potential.

核心SG&A成本在第一季增加了7%。這部分是由於對baxrostat的上市前投資所帶動，其在美國的PDUFA日期為2026年第二季。如各位所見，我們在2026年研發方面有一個非常強勁的開局，四個高價值專案取得成功，包括tozorakimab；為了最大化其潛力，將需要投入SG&A。

In addition, we have several other upcoming launches for products with high value potential, including baxtrostat, camizestrant and tozorakimab, all of which will help drive growth through 2030 and beyond. Other operating income increased to $189 million with some nonrecurring milestones booked in the quarter. Core operating profit grew by 12%, reflecting a strong underlying performance. Core EPS grew by 5% to $2.58 with growth rate impacted by low tax rate in Q1 2025.

此外，我們還有數個具高價值潛力產品即將上市，包括baxtrostat、camizestrant與tozorakimab，這些都將有助於推動至2030年及其後的成長。其他營業收入增加至1.89億美元，其中包含本季入帳的一些一次性里程碑款項。核心營業利益成長12%，反映強勁的基本面表現。核心每股盈餘（EPS）成長5%至2.58美元，成長率受到2025年第一季低稅率的影響。

Next slide, please. Cash flow from operating activities of $3.4 billion was a slight decline versus the same period last year due to large milestone received in Q1 2025, but partly offset by strong underlying performance. CapEx $600 million includes previously announced multiyear investments, such as our new ADC manufacturing facility in Singapore and our new manufacturing plant in Qingdao, China for an inhaled respiratory portfolio.

請看下一張投影片。營運活動現金流為34億美元，較去年同期略為下降，原因是2025年第一季收到一筆較大的里程碑款，但部分被強勁的基本面表現所抵銷。資本支出（CapEx）6億美元包含先前公布的多年期投資，例如我們在新加坡的新ADC製造設施，以及我們在中國青島為吸入式呼吸產品組合興建的新製造工廠。

We continue to anticipate CapEx to increase by around one-third in 2026. Deal payments of $1.1 billion include milestone payments to partner and an upfront payment for the Jakobi license agreement announced last year. We have now paid the last royalty payment for Forxiga. For the full year, we continue to anticipate milestone payments of around $2.5 billion relating to past transactions. The recent CSPC deal closed in April, so will be booked in the second quarter.

我們仍預期2026年的資本支出將增加約三分之一。交易付款11億美元包含支付給合作夥伴的里程碑款，以及去年宣布的Jakobi授權協議之預付款。我們現已支付Forxiga的最後一筆權利金。就全年而言，我們仍預期與過往交易相關的里程碑付款約為25億美元。近期的CSPC交易於4月完成，因此將在第二季入帳。

Our capital allocation priorities remain unchanged. Net debt increased by around $2.5 billion in the quarter, driven by a payment of the second FY 2025 interim dividend in March. We are comfortable with our current level of gross debt. And as previously indicated, we anticipate core finance expenses to increase this year, driven by higher lease expense and lower interest income.

我們的資本配置優先順序維持不變。本季淨負債增加約25億美元，主要由於3月支付了2025財年第二次中期股利。我們對目前的總負債水準感到安心。且如先前所述，我們預期今年核心財務費用將上升，主要受較高的租賃費用與較低的利息收入所驅動。

Today, we are reiterating our full year guidance. Total revenue is anticipated to increase by mid- to high single-digit percentage and core EPS is anticipated to increase by low double-digit percentage at the constant exchange rates.

今天，我們重申全年財測指引。在固定匯率下，預期總營收將以中至高個位數百分比成長，核心EPS預期將以低雙位數百分比成長。

Based on average March exchange rates, we anticipate a low single-digit positive FX impact on total revenue and a neutral impact on core EPS. In summary, a very strong financial performance in the quarter, and with the investments we are undertaking both in R&D and behind new launches, we are well placed to grow through 2030 and beyond.

以3月平均匯率為基礎，我們預期外匯（FX）對總營收帶來低個位數的正面影響，對核心EPS影響為中性。總結而言，本季財務表現非常強勁；隨著我們在研發以及新產品上市推進方面的投資，我們已具備良好條件在2030年及其後持續成長。

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

接下來我將交給Dave，他將帶各位回顧我們腫瘤業務的營運表現。

Thank you, Aradhana. Next slide, please. Oncology total revenues grew 16% in the first quarter to $6.8 billion with double-digit growth across all reported geographic segments. Performance in the US and Europe was particularly strong with growth of 18% and 19% over the prior year, respectively, continuing the momentum demonstrated through 2025.

謝謝你，Aradhana。請看下一張投影片。腫瘤業務第一季總營收成長16%至68億美元，所有揭露的地理區隔皆呈現雙位數成長。美國與歐洲表現尤其強勁，分別較去年成長18%與19%，延續了2025年以來的動能。

Turning now to quarterly performance of our key medicines. Tagrisso grew 5% in the quarter to revenues of $1.8 billion. Performance was driven by robust demand across all stages of EGFR-mutated lung cancer in the US and Europe, partially offset by higher than historic destocking in the US. In the frontline setting, Tagrisso remains the treatment of choice with an increasing proportion of physicians opting for the FLRT2 combination.

接著看我們主要藥品的季度表現。Tagrisso本季成長5%，營收達18億美元。表現主要由美國與歐洲在各期EGFR突變肺癌的強勁需求所帶動，但部分被美國高於歷史水準的去庫存所抵銷。在一線治療情境中，Tagrisso仍是首選療法，且選擇FLRT2聯合療法的醫師比例持續上升。

We anticipate continued growth over the balance of the year across all indications. Our foundational immuno-oncology assets Imfinzi and Imjudo delivered growth of 28% in aggregate, Infini growth of 30% was as in previous quarters, underpinned by robust demand growth across all regions. We are seeing an increasing contribution from more recent launches such as Matterhorn and gastric, Niagara in bladder and Adriatic in lung cancer, alongside continued growth in more established indications such as HIMALAYA and TOPAZ

我們預期在今年剩餘期間，各適應症將持續成長。我們的基礎免疫腫瘤資產Imfinzi與Imjudo合計成長28%；Imfinzi成長30%，與前幾季一致，並由各地區強勁的需求成長所支撐。我們看到較近期上市的適應症帶來愈來愈多的貢獻，例如Matterhorn與胃癌、Niagara於膀胱癌，以及Adriatic於肺癌；同時，較成熟的適應症如HIMALAYA與TOPAZ也持續成長

With continued strong demand for Imfinzi and Imjudo across indications, we are well positioned to sustain growth throughout the remainder of 2026. Calquence revenues grew 17% in the quarter to more than $900 million, with double-digit growth in all major regions. Focusing in on the US, Calquence continues to maintain its share leadership position in the frontline CLL setting, despite intense competition.

隨著Imfinzi與Imjudo在各適應症持續展現強勁需求，我們具備良好條件在2026年剩餘期間維持成長。Calquence本季營收成長17%至超過9億美元，所有主要地區皆呈現雙位數成長。聚焦美國市場，儘管競爭激烈，Calquence在一線CLL治療領域仍維持市占領先地位。

Our finite regimen for frontline CLL based on AMPLIFY is gaining momentum in reimbursed European markets and driving incremental new patient starts. While too early to comment on the trajectory in the US, excitement is building among prescribers and we believe Amplify will be a key contributor to growth this year.

我們以AMPLIFY為基礎的一線CLL有限療程方案，在已納入給付的歐洲市場正逐步加速，並帶動新增病患起始治療的增量。雖然現在評論其在美國的走勢仍為時過早，但處方醫師的期待正在升溫，我們相信Amplify將成為今年成長的重要貢獻者。

Turning to HER2, which is now annualizing as a $5 billion brand on an alliance view we delivered growth of 34% in the quarter, which was balanced across regions. This growth reflects ongoing demand in both the HER2-positive and HER2 low breast indications. In China, the exceptional performance we saw through 2025 post-NRDL enlistment continues into 2026, with share gains in both HER2-positive and low breast cancers.

接著談HER2；以聯盟口徑來看，該品牌目前年化規模已達50億美元。我們本季實現34%的成長，且各地區表現均衡。此成長反映HER2陽性與HER2低表現乳癌兩個適應症的持續需求。在中國，我們於2025年NRDL納入後所見的卓越表現延續至2026年，並在HER2陽性與HER2低表現乳癌兩個領域皆取得市占提升。

We're also seeing encouraging early signs of adoption of HER2 in first-line HER2-positive breast cancer in the US following the ESTINY-Breast09 approval in December last year. We look forward to broadening our reach further with additional launches in the early HER2-positive breast cancer later this year.

我們也看到在美國，繼去年12月ESTINY-Breast09獲批後，HER2於一線HER2陽性乳癌的採用出現令人鼓舞的早期跡象。我們期待在今年稍晚，隨著早期HER2陽性乳癌的更多上市，進一步擴大我們的觸及範圍。

Truqap revenues of $198 million in the quarter represents 47% growth over the prior year. We expect some further growth to be delivered in ex US markets, and we see US market share at peak. Datroway revenues of $43 million in the first quarter reflect ongoing demand in the US in later line EGFR mutated lung cancer with more than one in three third-line patients now treated with this medicine.

Truqap本季營收1.98億美元，較去年同期成長47%。我們預期在美國以外市場仍可帶來一些進一步成長，而我們認為美國市占已達峰值。Datroway第一季營收4,300萬美元，反映其在美國用於後線EGFR突變肺癌的持續需求，目前三線病患中已有超過三分之一接受此藥治療。

Following its acceptance for priority review, we look forward to the US approval of TROPION-Breast02 later this quarter. This has the potential to drive significant further growth for Datroway given the differentiated profile demonstrated in patients with metastatic triple-negative breast cancer that are not candidates for immunotherapy, an area of high unmet need. After a robust first quarter performance, we are excited about the outlook for the remainder of the year as we continue to deliver transformative regimens to more patients across the globe.

在獲受理優先審查後，我們期待本季稍晚TROPION-Breast02在美國獲批。鑑於其在不適合免疫治療的轉移性三陰性乳癌患者中所展現的差異化特性（此為高度未被滿足的需求領域），這有潛力推動Datroway顯著進一步成長。在第一季強勁表現之後，隨著我們持續在全球為更多患者提供具變革性的治療方案，我們對今年剩餘期間的前景感到振奮。

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

接下來，請切換到下一張投影片，然後我將交給Susan，說明本季研發的重點亮點。

Thank you, Dave. Earlier this month, we announced the positive results of the Phase 3 EMERALD- 3 trial. Building on the success of HIMALAYA in advanced liver cancer. EMERALD-3 now moves Imfinzi in combination with Imjudo into the earlier local regional setting with the goal of transforming outcomes for more patients with hepatocellular carcinoma.

謝謝你，Dave。本月稍早，我們公布了第3期 EMERALD-3 試驗的正面結果。在晚期肝癌 HIMALAYA 成功的基礎上，EMERALD-3 現在將 Imfinzi 與 Imjudo 的合併療法推進至更早的局部區域治療情境，目標是為更多肝細胞癌患者帶來轉變性的治療結果。

EMERALD-3 is a 3-arm trial, investigating whether the STRIDE regimen made up of a single priming dose of Imjudo together with regular interval dosing of Imfinzi with or without lenvatinib can improve outcomes when given before and then alongside standard of care transarterial chemoembolization, or taste.

EMERALD-3 是一項三組別試驗，評估由單次誘導劑量 Imjudo 搭配定期給藥 Imfinzi（合併或不合併 lenvatinib）的 STRIDE 方案，是否能在標準治療經動脈化學栓塞（transarterial chemoembolization，或 TACE）之前給予並於其後合併使用時，改善治療結果。

Data from the primary analysis are very encouraging, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival for the STRIDE plus lumber arm with a positive trend to overall survival. The STRIDE only arm also demonstrated a strong trend to both PFS and OS benefit, although this arm was not formally tested at this time.

主要分析的數據非常令人鼓舞，顯示 STRIDE 加上 lenvatinib 組在無惡化存活期方面達到具統計顯著性且具臨床意義的改善，且整體存活期呈現正向趨勢。僅 STRIDE 組亦顯示 PFS 與 OS 皆有強勁的獲益趨勢，惟此組在目前並未進行正式檢定。

We await further follow-up and are excited by the potential EMERALD-3 offers for more than 200,000 patients with local regional HCC currently eligible for embolization. We look forward to presenting the data at ASCO. EMERALD-3 marks the beginning of a series of high-value Imfinzi readouts over the course of 2026. In the coming months, we expect results from VOLGA, which will complement our Niagara indication in muscle invasive bladder cancer and further reinforce our position in genitourinary cancers.

我們正等待進一步追蹤，並對 EMERALD-3 為目前符合栓塞治療資格、超過 20 萬名局部區域 HCC 患者所帶來的潛力感到振奮。我們期待在 ASCO 發表相關數據。EMERALD-3 標誌著 2026 年期間一系列高價值 Imfinzi 讀出結果的開端。在接下來幾個月，我們預期將取得 VOLGA 的結果，該結果將補強我們在肌肉侵襲性膀胱癌的 Niagara 適應症，並進一步鞏固我們在泌尿生殖系癌症領域的地位。

Then in the second half of this year, we have two data sets that present opportunities to further broaden use of Imfinzi in lung cancer with AVANZAR aiming to improve outcomes and significantly expand in Fenza's reach in the first-line metastatic setting, and PACIFIC-9, which looks to consolidate and deepen our leadership in Stage 3 unresectable disease.

接著在今年下半年，我們將有兩組數據，提供進一步擴大 Imfinzi 在肺癌應用的機會：AVANZAR 旨在改善治療結果，並在第一線轉移性治療情境中顯著擴大 Imfinzi 的觸及；以及 PACIFIC-9，目標是在第3期不可切除疾病中鞏固並深化我們的領導地位。

Imfinzi is the current backbone of our immuno-oncology franchise, and we're excited by its potential to become standard of care across an even broader range of tumor types and settings. We're also excited to highlight several new developments from our oncology pipeline that will be presented at ASCO this year. Our in-house ADC program continues to progress at pace. We look forward to sharing more data on Puxi-Sam, our B7-H4 directed ADC in endometrial and ovarian cancers.

Imfinzi 是我們免疫腫瘤產品線目前的核心支柱，我們對其有望在更廣泛的腫瘤類型與治療情境中成為標準治療充滿期待。我們也很高興重點介紹今年將在 ASCO 發表的數項腫瘤研發管線新進展。我們自研的 ADC 計畫持續以快速節奏推進。我們期待分享更多 Puxi-Sam（針對 B7-H4 的 ADC）在子宮內膜癌與卵巢癌的數據。

And we're also excited to be moving forward with our plans to open two further Phase 3 trials for our folate receptor alpha-targeted ADC Torvutatug in ovarian cancer later this year. We will also share further data for sone-ve, including 18.2 positive gastric cancer from a broad global population which supports the ongoing Phase 3 clarity gastric 1 trial now expected to read out in the second half of this year.

此外，我們也很期待推進今年稍晚在卵巢癌中再啟動兩項針對葉酸受體 α（folate receptor alpha）的 ADC——Torvutatug——的第3期試驗計畫。我們也將分享 sone-ve 的進一步數據，包括來自廣泛全球族群的 HER2 18.2 陽性胃癌資料，支持目前進行中的第3期 Clarity Gastric 1 試驗，該試驗預計於今年下半年讀出結果。

Also at ASCO, additional evidence supports the use of our PD-1 TIGIT bispecific rilvegostomig in combination with HER2 in gastric cancer. Early phase data for volrustomig head and neck cancer will also demonstrate safety and efficacy in this indication.

同樣在 ASCO，更多證據支持我們的 PD-1/TIGIT 雙特異性抗體 rilvegostomig 與 HER2 聯合用於胃癌。volrustomig 在頭頸癌的早期階段數據也將展現其在此適應症的安全性與療效。

And finally, I want to highlight that we will present impressive first-in-human data for our PRMT5 inhibitor, AZAD3470 in a heavily pretreated classical Hodgkin's lymphoma population, strengthening our expanding hematology pipeline. ASCO 2026 looks set to be another significant congress for AstraZeneca.

最後，我想強調我們將發表 PRMT5 抑制劑 AZAD3470 的亮眼首次人體（first-in-human）數據，研究對象為既往接受多線治療的典型霍奇金氏淋巴瘤族群，進一步強化我們持續擴展的血液腫瘤研發管線。ASCO 2026 看來將再次成為阿斯特捷利康的重要大會。

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

接下來，請切換到下一張投影片，我將交由 Ruud 說明生物製藥事業的表現。

Thanks, Susan. Next slide, please. Our Biopharmaceuticals total revenue was broadly stable in the quarter, with growth in key brands, mostly offsetting the anticipated headwinds from Brilinta, Farxiga and roxadustat. Overall, biopharmaceuticals total revenue declined by 2% to $5.8 billion. (technical difficulty) to reach $483 million.

謝謝，Susan。請下一張投影片。本季我們的生物製藥總營收大致持平，關鍵品牌的成長大多抵銷了 Brilinta、Farxiga 與 roxadustat 所帶來的預期逆風。整體而言，生物製藥總營收下滑 2% 至 58 億美元。（技術問題）達到 4.83 億美元。

This was supported by a strong uptake in China following its NRDL listing with revenues in emerging markets, up 63%. Breztri generated $353 million in revenue, growing by 13%. Earlier this month, Breztri achieved its first label expansion beyond COPD with US approval for asthma. Breztri is the first and only triple therapy in asthma approved for patients aged 12 and older. Regulatory reviews continue in other countries.

這主要受惠於其納入 NRDL 後在中國的強勁採用，使新興市場營收成長 63%。Breztri 產生 3.53 億美元營收，成長 13%。本月稍早，Breztri 在 COPD 之外達成首次標籤擴增，於美國獲准用於氣喘。Breztri 是首個且目前唯一獲准用於 12 歲以上患者的氣喘三合一療法。其他國家的法規審查仍在進行中。

Tezspire continues to perform well and delivered $303 million in revenue, representing a growth rate of 34%. Tezspire is now approved for chronic rhinosinusitis with nasal polyps in all major markets following approval in Japan and China this quarter. Saphnelo grew 24% to achieve $171 million in revenue. The new subcutaneous formulation is now approved in Europe, the United States and Japan, which extends its reach to the large segment of patients who favor self-administration. 2026 marks a transition year for CVM as we navigate loss of exclusivity headwinds on ahead of the launch of several key pipeline medicines and new indications.

Tezspire 持續表現強勁，營收達 3.03 億美元，成長率為 34%。Tezspire 本季在日本與中國獲准後，現已在所有主要市場獲准用於伴鼻息肉的慢性鼻竇炎。Saphnelo 成長 24%，營收達 1.71 億美元。新的皮下劑型現已在歐洲、美國與日本獲准，將觸及範圍延伸至偏好自我施打的大量患者族群。2026 年將是 CVM 的轉型年度，我們將在多項關鍵研發管線藥物與新適應症上市之前，因應專利到期（LOE）所帶來的逆風。

CVRN total revenue for the first quarter stood at $3.3 billion, representing a decline of 6%. Farxiga total revenue fell 3% to $2.2 billion. Farxiga has a phased LOE profile and in quarter-one, that LOE effect was seen in established rest of the world and also with the implementation of VBP in China. As expected, generic manufacturers enter the US market in April. Our US markets continue to perform well, fueled by Farxiga's market share leadership within the fast-growing SGLT2 inhibitor class.

CVRN 第一季總營收為 33 億美元，下降 6%。Farxiga 總營收下滑 3% 至 22 億美元。Farxiga 的 LOE 影響呈分階段發生；在第一季，LOE 的影響已在既有的「世界其他地區」市場顯現，並且也受到中國推行 VBP 的影響。如預期，學名藥製造商於 4 月進入美國市場。我們在美國市場的表現仍然良好，主要受 Farxiga 在快速成長的 SGLT2 抑制劑類別中維持市占領先所帶動。

Lokelma achieved global market leadership in the potassium binder class and $199 million in the quarter, reflecting growth of 26%. Our commercial teams are preparing for the launch of baxdrostat later this year with the PDUFA date for FDA regulatory decisions set for quarter-two. If approved, baxdrostat will be the first aldosterone synthase inhibitor to serve patients with uncontrolled and resistant hypertension.

Lokelma 在鉀結合劑類別中取得全球市場領導地位，本季營收 1.99 億美元，成長 26%。我們的商業團隊正為今年稍晚 baxdrostat 的上市做準備；FDA 的 PDUFA 核准決策日期訂於第二季。若獲核准，baxdrostat 將成為首個醛固酮合成酶抑制劑，可用於未受控制及抗藥性高血壓患者。

In 2026, we anticipate gaining commercial access. And over time, we expect to see broader use across patients eligible for Part D reimbursement in line with the typical negotiation cycle. With the new approval for breast treatment asthma, the anticipated baxdrostat launch, the recent success of tozorakimab Phase 3 COPD program and the upcoming results from Wainua ATTR-PN trial we have much to look forward to across biopharmaceuticals this year.

我們預期在 2026 年取得商業給付准入。隨著時間推進，我們也預期將依照典型的協商週期，逐步在符合 Part D 給付資格的患者中看到更廣泛的使用。隨著 Breztri 新增核准用於氣喘治療、baxdrostat 預期上市、tozorakimab 第3期 COPD 計畫近期成功，以及即將公布的 Wainua ATTR-PN 試驗結果，今年在生物製藥領域有許多值得期待的里程碑。

I will now hand over to Sharon to take us through the exciting tozorakimab readouts in more detail.

接下來我將交由 Sharon，更詳細帶領大家了解令人振奮的 tozorakimab 讀出結果。

Thank you, Ruud. Next slide, please. I am delighted to share the significant progress from our respiratory pipeline this quarter with compelling new data that underscore our commitment to pioneering science and addressing the most urgent challenges in respiratory disease today and for the future. We recently reported high-level results from our three pivotal Phase 3 studies, and long-term extension study in our LUNA program studying tozorakimab in COPD, OBERON, TITANIA, MIRANDA and PROSPERO.

謝謝你，Ruud。請下一張投影片。我很高興分享本季我們呼吸道研發管線的重大進展，這些具說服力的新數據凸顯我們致力於開創性科學，並因應當前及未來呼吸道疾病最迫切挑戰的承諾。我們近期公布了 LUNA 計畫中三項關鍵第3期研究與長期延伸研究的高層級結果，該計畫評估 tozorakimab 用於 COPD，包含 OBERON、TITANIA、MIRANDA 與 PROSPERO。

This represents the most comprehensive Phase 3 program ever conducted for a COPD biologic, and the results reinforce our confidence in tosorakimab's potential to be a first and best-in-class treatment option for patients living with this devastating disease.

這代表迄今針對 COPD 生物製劑所進行過最全面的第 3 期計畫，而結果也強化了我們對 tosorakimab 潛力的信心，使其有望成為罹患這項毀滅性疾病患者的同類首創且同類最佳治療選擇。

COPD remains a critical area of unmet medical need. It is the third leading cause of death globally, claiming over 3 million lives each year. Even when patients are an inhaled standard of care, approximately half still experienced exacerbations, which amplifies their risk of cardiovascular events, including heart attack, stroke or even death.

COPD 仍是未被滿足醫療需求的關鍵領域。它是全球第三大死因，每年奪走超過 300 萬條生命。即使患者已接受吸入式標準治療，約有一半仍會出現惡化（急性加重），進而提高其心血管事件風險，包括心肌梗塞、中風，甚至死亡。

Importantly, only 50% of patients live more than 3.5 years after their first severe COPD exacerbation. These statistics underscore why innovation in COPD is so urgently needed. What sets tozoracumab apart is its dual-acting mechanism and the breadth of our clinical program. This is a true AstraZeneca science success story.

重要的是，患者在首次嚴重 COPD 急性加重後，只有 50% 的人能存活超過 3.5 年。這些統計數據凸顯了為何 COPD 的創新如此迫切需要。tozorakimab 的獨特之處在於其雙重作用機制以及我們臨床計畫的廣度。這是一個真正的阿斯特捷利康（AstraZeneca）科學成功案例。

Over a decade ago, our scientists uncovered IL-33's 2 distinct forms and their role in COPD. Our research confirmed the reduced form of IL-33 activates immune cells through the SP2 pathway. They also discovered that IL-33 released from cells undergoes oxidation and converts to a different form, which activates the RAGE EGFR pathway and the cycle of mucus production in COPD.

十多年前，我們的科學家揭示了 IL-33 的兩種不同形式及其在 COPD 中的作用。我們的研究證實，還原型 IL-33 會透過 SP2 路徑活化免疫細胞。他們也發現，IL-33 從細胞釋放後會發生氧化並轉換為另一種形式，進而活化 RAGE/EGFR 路徑以及 COPD 中黏液生成的循環。

These discoveries inform the development of tozorakimab, a differentiated molecule, which uniquely inhibits the signaling of both, reducing the inflammation and breaking the mucus dysfunction cycle, which drive disease worsening.

這些發現促成了差異化分子 tozorakimab 的開發；其可獨特地同時抑制兩者的訊號傳導，降低發炎並打破驅動疾病惡化的黏液功能失調循環。

In OBERON and TITANIA, tozorakimab achieved statistically significant and highly clinically meaningful reductions in the annualized rate of moderate-to-severe exacerbations. This efficacy was seen in former smokers and in the overall population, which included former and current smokers and had patients independent of eosinophil levels and lung function severity.

在 OBERON 與 TITANIA 試驗中，tozorakimab 在中度至重度急性加重的年化發生率方面達到具統計顯著性且臨床意義高度重大的降低。此療效在既往吸菸者以及整體族群中皆可見；整體族群包含既往與目前吸菸者，且不受嗜酸性球水平與肺功能嚴重程度影響。

MIRANDA, testing in every two-week regimen showed clinically meaningful benefits and exacerbation reduction as well. These results are truly exciting, marking the first time a biologic has demonstrated efficacy in COPD in three pivotal trials that enrolled broad populations.

MIRANDA 試驗在每兩週一次的給藥方案中也顯示具臨床意義的效益與急性加重降低。這些結果令人振奮，標誌著生物製劑首次在三項納入廣泛族群的關鍵性試驗中證實對 COPD 具有療效。

These results are further supported by PROSPERO, the long-term extension study of OBERON and TITANIA. While the narrower primary endpoint of severe exacerbations, those leading to hospitalization or death, did not reach statistical significance and former smokers, we observed a numerical reduction in this population and a nominally significant reduction in the overall population.

這些結果亦獲 PROSPERO 支持，該研究為 OBERON 與 TITANIA 的長期延伸試驗。雖然較狹義的主要終點——導致住院或死亡的嚴重急性加重——在既往吸菸者中未達統計顯著性，但我們在此族群觀察到數值上的降低，且在整體族群中觀察到名目上顯著的降低。

Tozorakimab was well tolerated with a favorable safety profile across the entire program. We are working at pace to share these data with the regulatory authorities and the scientific community with approximately 6 billion biologic-eligible patients globally. Tozorakimab has the potential to address the broadest population of COPD patients.

tozorakimab 在整個計畫中耐受性良好，且安全性概況有利。我們正加速與監管機關及科學界分享這些數據；全球約有 60 億名符合生物製劑治療資格的患者。tozorakimab 有潛力涵蓋最廣泛的 COPD 患者族群。

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

接下來請進到下一張投影片，我將交給 Marc 介紹罕見疾病。

Thank you, Sharon. Can I get the next slide, please? Rare Disease delivered total revenue of $2.4 billion in quarter one, up 15% year-over-year. This is driven by growth in neurology and metabolic diseases, increased patient demand and continued global expansion.

謝謝你，Sharon。可以請切到下一張投影片嗎？罕見疾病在第一季的總營收為 24 億美元，年增 15%。這主要由神經科與代謝性疾病的成長、患者需求增加以及持續的全球擴張所帶動。

If you recall, first quarter 2025 performance included transitory headwinds most notably tender market order timing for both Soliris and Strensiq. In the quarter, Ultomiris grew 18%, driven by patient demand across indications, including the competitive myasthenia gravis and PNH markets. Soliris revenues continued to decline due to successful conversion to Ultomiris as well as biosimilar pressure. This was partially offset by favorable order timing in certain tender markets.

如各位所記得，2025 年第一季的表現包含短期逆風，最顯著的是 Soliris 與 Strensiq 在部分標案市場的訂單時點影響。本季 Ultomiris 成長 18%，由各適應症的患者需求所驅動，包括競爭激烈的重症肌無力與 PNH 市場。Soliris 營收持續下滑，原因包括成功轉換至 Ultomiris 以及生物相似藥的壓力。部分下滑由某些標案市場較有利的訂單時點所抵銷。

Strensiq grew 43% year-on-year reflecting strong underlying demand and a favorable comparison versus the prior year. We saw demand growth for Koselugo, including the newly launched adult indication for NF1-PN patients. We continue to see great momentum across the rare disease portfolio.

Strensiq 年增 43%，反映強勁的基本需求以及相較去年同期的有利比較基期。我們也看到 Koselugo 的需求成長，包括新上市的成人適應症，適用於 NF1-PN 患者。我們持續在罕見疾病產品組合上看到良好動能。

Please advance to the next slide. I'm delighted to announce a positive high-level results for Phase 3 programs in rare metabolic and renal diseases. Efzimfotase alfa, our next-generation enzyme replacement therapy demonstrated positive results from the global Phase 3 clinical program for patients with HPP. The Marbury trial in treatment-naive pediatric HPP patients met its primary endpoint showing meaningful improvements in bold health as well as other objective endpoints, including physical function and quality of life.

請切到下一張投影片。我很高興宣布罕見代謝與腎臟疾病第 3 期計畫的正面高層級結果。Efzimfotase alfa 作為我們的新一代酵素替代療法，在針對 HPP 患者的全球第 3 期臨床計畫中展現正面結果。Marbury 試驗於未接受治療的小兒 HPP 患者中達成主要終點，顯示骨骼健康以及其他客觀終點（包括身體功能與生活品質）皆有具意義的改善。

In parallel, the CHESTNUT Phase 3 trial showed that [Efzimfotase alfa] was well tolerated in children switching from Strensiq while maintaining benefit on bone health. In the (inaudible) Phase 3 trial in adolescent and adult with (inaudible) efzimfotase alfa demonstrated numerical improvements but did not achieve statistical significance in the primary endpoint of 6-minute walk test in patients who have been -- who have not been previously treated with Strensiq compared to placebo.

同時，CHESTNUT 第 3 期試驗顯示，[Efzimfotase alfa] 在由 Strensiq 轉換治療的兒童中耐受性良好，並可維持對骨骼健康的效益。在（聽不清）第 3 期試驗中，針對青少年與成人（聽不清）患者，efzimfotase alfa 雖呈現數值上的改善，但在主要終點——6 分鐘步行測試——上，與安慰劑相比，對於先前未接受 Strensiq 治療的患者未達統計顯著性。

The results show clinically meaningful impact on mobility, physical function, pain and fatigue that are key aspects of this heterogenous disease that are beyond one single endpoint such as the 6-minute walk test, the only approved adult endpoint.

結果顯示其對行動能力、身體功能、疼痛與疲勞具有臨床上具意義的影響；這些是此異質性疾病的關鍵面向，並非單一終點（例如 6 分鐘步行測試——目前唯一獲核准的成人終點）所能完全涵蓋。

Efzimfotase alfa represent patients and third innovation improving upon Strensiq profile for a longer half life, more patient-friendly dosing and an improved manufacturing process. The Phase 3 trials were designed to reflect the broad symptomatology of HPP and efzimfotase alfa's well positioned for global adoption by removing key barriers to access.

Efzimfotase alfa 代表我們在 Strensiq 基礎上的第三項創新，具更長的半衰期、更以患者為友善的給藥方式，以及改良的製造流程。第 3 期試驗的設計旨在反映 HPP 的廣泛症狀表現，而 efzimfotase alfa 透過移除取得治療的關鍵障礙，已具備在全球被採用的良好定位。

There are approximately 14,000 addressable patients across the top 8 countries. Approximately 20% of these are pediatric cases, 60% adult with pediatric onset disease and 20% adult with adult-onset disease. We will share data across the program with regulators and present at an upcoming medical meeting.

在前 8 大國家中，約有 14,000 名可觸及的患者。其中約 20% 為小兒病例，60% 為成人但屬小兒起病，另有 20% 為成人且屬成人起病。我們將與監管機關分享整個計畫的數據，並於即將到來的醫學會議上發表。

We believe efzimfotase alfa represents a pick-yourself sales opportunity of $3 billion to $5 billion. In addition, we recently announced positive high-level results from a prespecified interim analysis of the ICAN Phase 3 trial, which showed that Ultomiris met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in proteinuria based on 24 hours urine protein creatinine ratio at week 34 in adults with IgAN who are at risk of disease progression.

我們相信 efzimfotase alfa 代表一個可自行掌握的 30 億至 50 億美元銷售機會。此外，我們近期宣布 ICAN 第 3 期試驗依預先規劃的期中分析所得到的正面高層級結果：Ultomiris 達成主要終點，在第 34 週時，於有疾病進展風險的 IgAN 成人患者中，基於 24 小時尿蛋白/肌酸酐比值顯示蛋白尿具有統計顯著且臨床意義重大的降低。

The primary endpoint of change from baseline in estimated glomerular filtration rate will be measured at week 106. Ultomiris demonstrated complete and sustained terminal complement inhibition with protein reduction seen as early as week 10. Benefits are consistent across patients, including those at higher risk of progression and with more inflammatory disease.

主要終點——估算腎小球過濾率（eGFR）相較基線的變化——將於第 106 週測量。Ultomiris 展現完全且持續的末端補體抑制，且蛋白尿降低最早可於第 10 週觀察到。效益在各類患者中一致，包括進展風險較高以及發炎程度較高的患者。

Importantly, updated 2025 Cardio guidelines recommend using disease-modifying agents such as Ultomiris in combination with supportive medicine that manage a disease symptoms such as RAS or agility inhibitors. Across US, Japan and the EU5, there are over 560,000 patients diagnosed with IgAN and 60% of patients would be eligible for IgAN treatment based on proteinuria.

重要的是，更新後的 2025 年心腎（Cardio）指引建議，使用如 Ultomiris 等疾病修飾藥物，並與可管理疾病症狀的支持性藥物（例如 RAS 或 SGLT2 抑制劑）合併使用。在美國、日本與歐盟五國（EU5），確診 IgAN 的患者超過 56 萬人，其中 60% 的患者將因蛋白尿而符合 IgAN 治療資格。

We are confident this indication could reach blockbuster potential, given our established nephrology presence across AstraZeneca and Alexion and we are seeking accelerated approval in key markets. In addition, today, we disclosed the discontinuation of Ultomiris in CSA AKI high-risk patients with skin ischemia due to lack of consistent efficacy across CKD severities.

鑑於我們在 AstraZeneca 與 Alexion 於腎臟科領域既有的布局與影響力，我們有信心此適應症具備成為重磅產品（blockbuster）的潛力，並正尋求在主要市場取得加速核准。此外，我們今日也揭露，由於在不同 CKD 嚴重程度間未能展現一致療效，我們已停止 Ultomiris 於 CSA AKI 高風險且合併皮膚缺血患者中的開發。

And finally, I'm pleased to report that CALYPSO, our Phase 3 trial investigating the safety and efficacy of enable paratide in adults with chronic epoparatoodism will be presented at ECE in May and CARES our Phase 3 program of anselamimab in (inaudible) mylodosis patients will be presented at ASCO in June. These presentations mark important milestone in bringing new therapeutic option to people living with rare diseases.

最後，我很高興報告，CALYPSO——我們在成人慢性甲狀旁腺功能低下症中評估 enable paratide 安全性與療效的第 3 期試驗——將於 5 月在 ECE 發表；而 CARES——我們在（聽不清）骨髓沉積症患者中評估 anselamimab 的第 3 期計畫——將於 6 月在 ASCO 發表。這些發表是為罕見疾病患者帶來新的治療選擇的重要里程碑。

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

接下來請切到下一張投影片，我把時間交還給 Pascal。

Thank you, Marc. Next slide, please. We are off to a strong start with four meaningful programs readouts already delivered in 2026 and a risk catalyst pass across the rest of the year. As shown here, the volume of high-value readouts for the year is notable, collectively pointing to a risk-adjusted peak year revenue potential exceeding $10 billion. supporting growth of the company to 2030 and well beyond.

謝謝你，Marc。下一張投影片，謝謝。我們在 2026 年已交付四項具意義的計畫讀出，並且在今年剩餘時間仍有一連串風險催化事件。如圖所示，今年高價值讀出的量相當可觀，整體指向經風險調整後的峰值年度營收潛力超過 100 億美元，支撐公司成長至 2030 年及更長遠。

Next slide, please. As you can see, our recent success is resulting in an extremely eventful year in 2026. We're excited to showcase our positive data from several programs at upcoming congresses, including ASCO and EDA. We're also expecting a significant wave of approvals including the potential first approval of four NMEs and four life cycle management indication. We also look forward to additional regulatory decisions in major markets to continue to bring our medicines to more patients across the globe.

下一張投影片，謝謝。如各位所見，我們近期的成功使得 2026 年成為極為多事的一年。我們很期待在即將到來的學術會議（包括 ASCO 與 EDA）展示多個計畫的正面數據。我們也預期將迎來一波重要核准，其中可能包括四項新分子實體（NME）的首次核准，以及四項生命週期管理適應症。我們也期待在主要市場取得更多法規決策，持續把我們的藥物帶給全球更多患者。

Next slide, please. In closing, Q1 delivered strong commercial momentum and excellent pipeline execution, reinforcing our growing confidence in achieving our 2030 ambition. With a broad portfolio, a deep pipeline, and meaningful advances across multiple transformative technologies, we are well positioned to extend growth beyond 2030.

下一張投影片，謝謝。總結而言，第一季展現強勁的商業動能與優異的研發管線執行力，進一步強化我們達成 2030 年目標的信心。憑藉廣泛的產品組合、深厚的研發管線，以及多項具變革性的技術取得實質進展，我們已具備在 2030 年後延續成長的良好定位。

And with that, please advance to the next slide, and we will move to the Q&A. As Joris mentioned at the start of the call, and we will see if he's more successful than his predecessor Andy. (Event Instructions)

接下來請切到下一張投影片，我們將進入問答環節。如 Joris 在電話會議一開始提到的，我們也看看他是否能比他的前任 Andy 更成功。(活動指示)

Richard Vosser, JPM.

Richard Vosser，摩根大通（JPM）。

Two questions, please. First question on tozorakimab. Could you characterize how you see the product profile relative to Dupixent and Nucala? And do you think the breadth of activity sufficiently differentiates the product so physicians wouldn't need to test for eosinophils anymore?

兩個問題，謝謝。第一個問題關於 tozorakimab。你們如何描述該產品相較於 Dupixent 與 Nucala 的產品特性？你們是否認為其作用範圍的廣度足以形成差異化，使醫師不再需要檢測嗜酸性球？

And then a second question, just on the ramp of Enhertu. Could you just give us a bit of color around the DB09 rollout and how we should think about the pace of uptake for the adjuvant setting and neoadjuvant setting in DB11, DB05?

第二個問題是關於 Enhertu 的放量（ramp）。能否請你們補充一些 DB09 上市推廣（rollout）的情況，以及我們應如何看待在輔助治療（adjuvant）與新輔助治療（neoadjuvant）情境下、於 DB11、DB05 的採用速度？

Thanks, Richard. Joris didn't go very far, right? You failed on the first step. Who is going to take the tozo. Sharon, do you want to take this? Ruud, if you have anything you want to add later?

謝謝你，Richard。Joris 沒走多遠，對吧？你第一步就失敗了。誰要來回答 tozo 的問題？Sharon，你要回答嗎？Ruud，如果你之後想補充也可以。

Sure. I'm happy to. So as you know, we announced the positive high-level for tozorakimab in OBERON AND TITANIA and MIRANDA. And in these Phase III studies, we were able to demonstrate that we had a statistically significant, and in the case of OBERON and TITANIA, highly clinically meaningful result, both in the primary and in the overall population. So our primary population was former smokers.

當然。我很樂意。如各位所知，我們已公布 tozorakimab 在 OBERON、TITANIA 與 MIRANDA 的正面高層級結果。在這些第 3 期研究中，我們證明在主要族群以及整體族群皆達到統計上顯著；且在 OBERON 與 TITANIA 中，結果在臨床上也具有高度意義。我們的主要族群是既往吸菸者。

Our overall population included former and current smokers, patients across all blood eosinophil counts, and all stages of lung function severity. Now we can't slice and dice those data until we present them at an upcoming medical meeting. But we are encouraged by the data that we have seen, and we've characterized it as highly clinically meaningful in the case of OBERON and TITANIA, and we are moving at pace to submit that to regulators.

我們的整體族群包含既往與目前吸菸者、涵蓋所有血中嗜酸性球計數的患者，以及各種肺功能嚴重程度分期。目前在即將到來的醫學會議正式發表之前，我們還不能對數據進行更細的分層分析。但我們對已看到的數據感到鼓舞；在 OBERON 與 TITANIA 的情況下，我們將其描述為在臨床上高度具意義，並正加速向監管機關提交。

Yes. And the only thing, Richard, I would like to add regarding the potential is that the current biologics in COPD are primarily for high eosinophils. The studies were done above 300. I think the uniqueness, as Sharon has shared is that this is across the eosinophil count of patients. So whether in the end of the day, physicians want to test in COPD, the eosinophil count is up to them. But we are hoping for a very broad label on the basis of the OBERON AND TITANIA data.

是的。Richard，我想補充的一點是，現有用於 COPD 的生物製劑主要針對高嗜酸性球族群。相關研究多是在 300 以上進行。我認為其獨特性——如 Sharon 所分享——在於它涵蓋不同嗜酸性球計數的患者。因此，最終醫師是否要在 COPD 中檢測嗜酸性球計數，取決於他們。但我們希望基於 OBERON 與 TITANIA 的數據，能取得非常廣泛的標示（label）。

Yes. And I think really, of course, it's left up to physicians, but we think we have a true all-comers product from that viewpoint of EOS levels. Dave, do you want to take the Enhertu question?

是的。我想從嗜酸性球（EOS）水準的角度來看，當然最終仍由醫師決定，但我們認為這是一個真正適用於所有患者（all-comers）的產品。Dave，你要回答 Enhertu 的問題嗎？

Yes, absolutely. Thank you very much. So at the highest level, Enhertu with DB09 clearly is bringing transformative benefit with PFS now exceeding 40 months. That has been very well received in our promotional efforts that we've been engaging in. We're seeing encouraging early adoption across a broad frontline population.

是的，當然。非常感謝。從最高層級來看，Enhertu 在 DB09 中明顯帶來具變革性的效益，無惡化存活期（PFS）如今已超過 40 個月。這在我們所進行的推廣活動中獲得非常正面的回響。我們看到在廣泛的一線治療族群中，早期採用情況令人鼓舞。

So utilization both in hormone receptor negative and hormone receptor positive patients. We do, as you would expect, see academic HCPs are driving early adoption more so than you would see within the community within this first quarter post launch, but we will look forward to continuing to see our efforts in the community. And I think importantly, we are seeing increased recognition of the importance of continuing in HER2 treatment for a prolonged duration.

因此，不論是荷爾蒙受體陰性或荷爾蒙受體陽性的患者，都有使用。如各位所預期，在上市後第一季，學術醫療專業人員（HCP）推動早期採用的程度高於社區端；但我們也期待持續推進在社區端的工作。而且我認為很重要的是，我們看到對於在 HER2 治療上需要更長期持續用藥的重要性，正獲得更多認同。

With less consideration of this sort of maintenance notion, which I know was something that we had gotten some questions about coming out of ASCO. In terms of the early breast cancer studies with 05 and 11, I think they build really nicely on the existing confidence that exists within the HER2-positive space with 03, 09 and now these studies. We've got upcoming PDUFA dates here shortly, and I think that there's a lot of energy around both of those studies and incorporating them into practice.

對於所謂維持治療（maintenance）的概念，考量正在降低；我知道這是我們在 ASCO 之後收到的一些問題。至於早期乳癌的 05 與 11 研究，我認為它們在既有的 HER2 陽性領域信心基礎上（03、09 以及現在這些研究）形成很好的延伸。我們即將迎來 PDUFA 目標日期，我認為市場對這兩項研究以及將其納入臨床實務都充滿動能。

James Gordon, Barclays.

James Gordon，巴克萊（Barclays）。

Hopefully, you can hear me now. James Gordon from Barclays. The question was on camizestrant for hormonal breast cancer and the route to this being a $5 billion-plus product. So I know you've got a couple of angles, but one is the SERENA-4 readout in the second half. But on that one, to what extent does failure of Roche's persevERA first-line metastatic ESR1 all-comers trial mean you're more cautious on that readout?

希望你們現在聽得到我。我是巴克萊的 James Gordon。問題是關於 camizestrant 用於荷爾蒙性乳癌，以及它成為一個 50 億美元以上產品的路徑。我知道你們有幾個切入角度，其中之一是下半年 SERENA-4 的讀出。但就這一點而言，Roche 的 persevERA 一線轉移性 ESR1 全人群試驗失敗，在多大程度上會讓你們對該讀出更為謹慎？

A other important differences like maybe patient enrichment or the potency of your drug or other factors that mean you still think you've got a good shot at this? Or is this quite a long shot based on persevERA?

還有其他重要差異，例如可能的病人富集、你們藥物的效力，或其他因素，讓你仍然認為你們在這方面有很大勝算嗎？還是說，基於persevERA，這其實是相當長的機率（勝算不大）？

And I know the other angle, probably the bigger angle would be adjuvant hormonal breast cancer, which that could be a $20 billion-plus category. But I think your CAMBRIA-2 trial, which is like the analogous trial to lidERA that's already up for approval in Q4 for Roche, that's only going to have final data in 2013 still recruiting. So is there a way you can still be a big winner here? Or is it looking tougher?

而且我知道另一個角度，可能是更大的角度，會是輔助性內分泌治療的乳癌，這可能是一個超過200億美元的類別。但我認為你們的CAMBRIA-2試驗，類似於Roche那個在第四季就要申請核准、與lidERA相對應的試驗，你們這個要到2013年才會有最終數據，而且仍在招募中。所以你們還有辦法在這裡成為大贏家嗎？還是看起來更艱難了？

Okay. Thanks for the question. So in terms of the first-line metastatic hormone receptor positive patient population, obviously, we'll have to wait and see the persevERA data at ASCO. But remember that we've said that we do have a differentiated asset in camizestrant. The effect size that we saw in the second-line setting was robust in both the ESR mutant and wild-type.

好的。謝謝你的問題。就第一線轉移性、荷爾蒙受體陽性的病人族群而言，顯然我們必須等到ASCO公布persevERA數據後再看。但請記得，我們一直說camizestrant是一個具差異化的資產。我們在第二線治療情境看到的效果幅度，在ESR突變與野生型兩個族群中都很穩健。

And we also have enriched the first-line patient population to hopefully enrich for a greater endocrine sensitive population. One key differentiation as well from the persevERA study for SERENA-4 is it's a much larger patient population. So we sized for an effect size that will still be clinically meaningful in that population. So that's why I think we need to look out for both what the safety and the efficacy data are for persevERA at ASCO.

而且我們也在第一線病人族群做了富集，希望能富集出對內分泌治療更敏感的族群。另外，SERENA-4相較於persevERA研究的一個關鍵差異是：它的病人數規模大得多。因此我們的樣本數設計，是以在該族群中仍具臨床意義的效果幅度為目標。所以我認為，我們需要在ASCO同時關注persevERA的安全性與療效數據。

Moving on to the adjuvant population. Just as a reminder, we have two adjuvant studies, CAMBRIA-1 and CAMBRIA-2. So CAMBRIA-1 study takes the patient population that's already had two- to five years of CDK4/6 inhibition. So that's the, if you like, the prevalent patient population of ER-positive. And then CAMBRIA-2 is in a setting that's more similar to lidERA, but is differentiated from lidERA because it does allow for combination with CDK4/6 in the adjuvant setting.

接著談輔助治療族群。提醒一下，我們有兩個輔助治療研究：CAMBRIA-1與CAMBRIA-2。CAMBRIA-1研究納入的是已接受2到5年CDK4/6抑制劑治療的病人族群。所以這可以說是ER陽性病人的既有（存量）族群。而CAMBRIA-2是在一個更類似lidERA的情境，但它與lidERA的差異在於：它允許在輔助治療情境中與CDK4/6合併使用。

And given the benefit that's been seen with CDK4/6 inhibitors in the adjuvant setting, there's an increasing demand from patients and treating physicians to treat with CDK4/6 in that setting. So if you think about the combination of CAMBRIA-1 and -2 together, I think we have the opportunity to get the largest share of the adjuvant patient population given that.

鑑於CDK4/6抑制劑在輔助治療情境中已觀察到的效益，病人與治療醫師對於在該情境使用CDK4/6的需求正在增加。因此，如果把CAMBRIA-1與-2合在一起看，我認為我們有機會在輔助治療病人族群中取得最大的市占，正是基於這一點。

And the success of lidERA, I think, does show that, first of all, there's positive proof of concept for the effect of these drugs in that setting. And given that we've got a very good profile with camizestrant, I think that builds confidence on our likelihood of success in those settings.

而lidERA的成功，我認為首先顯示了在該情境中這類藥物效果的正向概念驗證。再加上camizestrant的整體特性非常好，我認為這也提升了我們在這些情境中成功的信心。

Sachin Jain, Bank of America.

Sachin Jain，美國銀行。

One topic, Wainua in CARDIO-TTRansform, a question for both Sharon and Ruud. But for Sharon, as we head into the Phase III, could you just remind us of a few factors. So could you remind us of TAF and SGLT usage at baseline and whether you think that will complicate a cross-trial comparison versus the 30% benefit AMVUTTRA in HELIOS-B?

一個主題：CARDIO-TTRansform中的Wainua，這個問題想同時問Sharon與Ruud。不過先問Sharon，當我們邁向第三期時，你能否提醒我們幾個因素？也就是，請你提醒我們基線時TAF與SGLT的使用情況，以及你是否認為這會讓與HELIOS-B中AMVUTTRA 30%效益的跨試驗比較變得更複雜？

And then on the secondary TAF subgroup, are you powered to be statistically significant if you repeat the AMVUTTRA benefit? And then just a quick one for Ruud. If you could just talk to the commercial relevance of both of those points, cross-trial benefit comparison, and the secondary endpoint.

然後關於次要的TAF亞組，你們是否有足夠的統計檢定力（power），在重現AMVUTTRA效益的情況下達到統計顯著？再快速問Ruud一題：你能否談談這兩點在商業上的相關性：跨試驗效益比較，以及次要終點？

Thanks, Sachin. Sharon, do you want to start?

謝謝你，Sachin。Sharon，你要先開始嗎？

Sure. So Sachin, let me just clarify the question because there was a little bit of a skip. I think you were asking about the number or the rate of SGLT2 background therapy?

當然。Sachin，我先澄清一下問題，因為剛剛有一點斷訊。我想你是在問SGLT2背景治療的人數或比例？

So 2 bits. So TAF, tafamidis, and SGLT2 usage at baseline and whether that complicates cross-trial versus AMVUTTRA, 30% benefit and then the secondary TAF subgroup powering.

兩個部分。也就是基線時TAF（tafamidis）與SGLT2的使用情況，是否會讓與AMVUTTRA的跨試驗比較變得複雜（AMVUTTRA有30%效益）；以及次要的TAF亞組在檢定力上的設計。

All right. So now we haven't disclosed the exact numbers there. But let me speak broadly about this. We always anticipated that the treatment landscape would evolve during the time that we're running the CARDIO-TTRansform study, and we designed a large study to account for that. The baseline standard of care treatments, and here, you've included SGLT2 and tafamidis, so stabilizer and SGLT2 are expected to have an impact on the event rate, but we previously extended our trial duration to account for that.

好的。我們目前尚未揭露確切數字。但我可以從整體角度談談。我們一直預期在執行CARDIO-TTRansform研究期間，治療環境會持續演變，因此我們設計了一個大型研究來因應這點。基線的標準照護治療——你提到的SGLT2與tafamidis，也就是穩定劑與SGLT2——預期會影響事件發生率，但我們先前已延長試驗期間以納入這些影響。

If we look at the HELIOS-B study, the treatment effect with vutrisiran versus placebo looked very similar in trial participants who were on background tafamidis versus those who were not. So while we think background therapy should have an effect on event rates, we don't expect the differences in background therapy to have an effect on the overall treatment benefit.

如果看HELIOS-B研究，vutrisiran相較於安慰劑的治療效果，在有使用背景tafamidis的受試者與未使用者之間看起來非常相似。因此，雖然我們認為背景治療會影響事件發生率，但我們不預期背景治療的差異會影響整體治療效益。

You also asked about secondary endpoints. As you know, we designed the secondary endpoints to evaluate different patient subsets. And one of those is patients on tafamidis versus those who are not. And if we are able to demonstrate statistical significance, and it depends on how far we go through the statistical analysis plan, we view this as the icing on the cake. Ruud, would you like to comment further?

你也問到次要終點。如你所知，我們設計次要終點是為了評估不同的病人子族群。其中之一就是使用tafamidis的病人與未使用者。如果我們能證明統計顯著——而這取決於我們在統計分析計畫中能走到哪一步——我們會把這視為錦上添花。Ruud，你要再補充嗎？

Yes. Thank you so much. And regarding, let's say, the peak year sales, Sachin, we have indicated in 2024 during the Investor Day that we see this asset as a $5 billion-plus asset. I think, of course, as always, it's incredibly important to hit the primary endpoint and the primary endpoint is different from the endpoint of in the Alnylam trials with AMVUTTRA, because here, we are talking about the change from baseline to a composite endpoint of cardiovascular death plus CV recurrent events up to 140 weeks.

是的。非常感謝。至於例如峰值年度銷售額（peak year sales），Sachin，我們在2024年的投資人日已指出，我們認為這個資產有超過50億美元的潛力。當然，一如既往，達成主要終點極其重要；而且這裡的主要終點與Alnylam針對AMVUTTRA的試驗終點不同，因為我們談的是從基線到一個複合終點的變化：心血管死亡加上心血管（CV）反覆事件，追蹤最長至140週。

So that in itself, I think, is a very important part of the differentiation of Wainua versus the competition. Now equally, as Sharon mentioned, every secondary we can hit will further differentiate our product from the competition. So let's wait and see, but we remain highly excited about the prospects of this asset.

因此，我認為這本身就是Wainua相較競品的一個非常重要的差異化點。同樣地，如Sharon所提到的，我們每達成一個次要終點，都會進一步讓我們的產品相較競品更具差異化。所以就讓我們拭目以待，但我們仍對這個資產的前景感到非常振奮。

Graham Parry, Citi.

Graham Parry，花旗。

It's one on tozorakimab again. Just wondering if we -- you can confirm that we should interpret the way the headline press release was worded and your comments today to mean that the effect size across the different eosinophil groups is consistent across those groups. I think you talked just now about potentially having a broad label. So that would be the interpretation.

又是一題關於tozorakimab。我想確認一下——你能否確認，我們應該將新聞稿標題的措辭方式以及你今天的評論解讀為：在不同嗜酸性球分組之間，效果幅度在各組之間是一致的。我想你剛剛提到可能會有一個廣泛的適應症標籤。所以這會是上述的解讀。

And then secondly, could you just give some sort of clarity as to what you think the implication of PROSPERO missing is and perhaps some rationale as to how you could have such highly clinically meaningful data in the MIRANDA and OBERON trials without missing on the endpoint PROSPERO?

其次，您能否再釐清一下，您認為 PROSPERO 未達標的意涵是什麼？以及或許說明一下，為何在 MIRANDA 與 OBERON 試驗中能看到如此具臨床意義的高度數據，卻在 PROSPERO 的終點上未達標？

So I hope, Sharon, you got the second question because the line broke up a bit. On the first one, I can quickly answer. We expect -- we hope and our expectation is we will get a broad level, including all EOS level, but we can't today disclose the results in each group. You will see this when we present the data. And the second question, PROSPERO, Sharon, hopefully, you got it in full?

所以我希望 Sharon，您有聽到第二個問題，因為線路有點斷斷續續。第一個問題我可以很快回答。我們預期——我們希望且我們的預期是——我們會得到廣泛層級的結果，包括所有 EOS 層級，但我們今天無法揭露各組別的結果。您會在我們發表數據時看到。第二個問題，關於 PROSPERO，Sharon，希望您完整聽到了？

Yes, I did hear the question. So I'll just repeat that PROSPERO was the long-term extension study and that PROSPERO was unique from OBERON, TITANIA and MIRANDA in that it had a different primary endpoint. It looks specifically at severe COPD exacerbations, those that cause hospitalization and death over the duration of 104 weeks.

是的，我有聽到這個問題。我再重申一次，PROSPERO 是長期延伸研究，且 PROSPERO 與 OBERON、TITANIA 和 MIRANDA 的不同之處在於它有不同的主要終點。它特別觀察嚴重 COPD 惡化，也就是在 104 週期間內導致住院與死亡的事件。

We really look forward to sharing the data. This will be a component of our regulatory package. We are really delighted with the overall data that we've seen across the LUNA program. PROSPERO supports the clinical profile of tozorakimab, and we look forward to submitting our data in totality to the regulators as quickly as possible.

我們非常期待分享這些數據。這將是我們法規申報資料包的一部分。我們對於在 LUNA 計畫中所看到的整體數據感到非常振奮。PROSPERO 支持 tozorakimab 的臨床特徵，我們也期待盡快將完整數據提交給主管機關。

Sarita Kapila, Morgan Stanley.

Sarita Kapila，Morgan Stanley。

So you've had a number of successes for Datroway across lung and breast cancer, as you've outlined. So how should we now think about the totality of the commercial opportunity? And are you confident in reaching multibillion peak sales for Datroway excluding AVANZAR?

如您所述，Datroway 在肺癌與乳癌方面已取得多項成功。那麼我們現在應如何看待整體的商業機會？以及在不包含 AVANZAR 的情況下，您是否有信心 Datroway 的峰值銷售可達數十億美元？

And then just a quick one on efo alfa. How has the initial dialogue with the FDA been? And is there scope for approval in the subgroup of adolescents and adults with pediatric onset? And perhaps you could quantify what percentage or how large this population is?

另外快速問一下 efo alfa。與 FDA 的初步對話進展如何？是否有機會在「青少年與成人（但為兒童期發病）」這個亞族群獲得核准？以及您能否量化這個族群約占多少比例或規模有多大？

Thank you. I think, Dave, you can take the second one. The first one, second one is for you, Marc. But if you -- Sarita, if you go back to the script, I mean, maybe Marc can repeat it. Marc gave the split of the various groups, pediatric, pediatric onset, adult and adult onset. For the first question, Dave, do you want to go?

謝謝。我想，Dave，你可以回答第二個。第一個——第二個是給你，Marc。不過 Sarita，如果你回到逐字稿，我的意思是，也許 Marc 可以再重述一次。Marc 已經說明了各族群的拆分：兒科、兒童期發病的成人、成人，以及成人期發病。第一個問題，Dave，你要先回答嗎？

Yes, Sarita, I think that the best way to address this is that when we laid out a $5 billion-plus ambition on Datroway. We continue to see the opportunity being just that. And we've got a series of really important readouts that are going to be happening over the course of the next several quarters.

好的，Sarita，我認為回答這題最好的方式是：當我們提出 Datroway 50 億美元以上的目標時，我們仍然認為機會就是如此。而且在接下來幾個季度，我們將有一系列非常重要的讀出結果。

Obviously, we've got AVANZAR TL07, TL08, but also we've got TROPION-Lung15, and then that will be followed afterwards by TROPION-Lung14 and a series of Dato studies incorporating with Next-wave IO. So we've got quite a few programs underway. Lung cancer is obviously an important element of this. The work that we've done on QCS, we think, has positioned us well to be able to have multiple shots on goal within the AVANZAR study, and we're confident in the forecasts that we've got at this time.

很明顯地，我們有 AVANZAR TL07、TL08，同時也有 TROPION-Lung15，之後還會有 TROPION-Lung14，以及一系列將 Dato 與 Next-wave IO 結合的研究。所以我們正在推進相當多的計畫。肺癌顯然是其中的重要組成。我們在 QCS 上所做的工作，我們認為已讓我們在 AVANZAR 研究中具備多次命中目標的機會，我們也對目前的預測有信心。

It's important to really keep in mind, our view hasn't changed about the potential of this agent since the time when Dave talked about it back a little while ago. Of course, all these studies have to work, in particular, AVANZAR, but our view hasn't changed. Marc, do you want to cover the second?

重要的是要記住，自從 Dave 在前一段時間談到這個藥物以來，我們對其潛力的看法並沒有改變。當然，所有這些研究都必須成功，尤其是 AVANZAR，但我們的看法沒有改變。Marc，你要回答第二個嗎？

Yes. So maybe I'll take the second question first. In my prepared remarks, I had indicated that the pediatric cases are about 20%. The adults with pediatric onset would be 60%. And then the remaining 20% are covered by adult with adult onset. So these are -- this is basically the breakdown of the population suffering from HPP.

好的。那我先回答第二個問題。在我事先準備的發言中，我提到兒科病例約占 20%。兒童期發病的成人約占 60%。剩下的 20% 則是成人且為成人期發病。所以這基本上就是 HPP 患者族群的分布。

In terms of data, as I've explained, we have three clinical trials, which we are going to submit to authorities. The first two are on the pediatric population. And the third one is on adolescent and adults with as a primary endpoint, six-minute walk test, but there are many other endpoints which are measured in this trial, and we have concluded that this study is clinically meaningful, and therefore, we are going to submit this data to the regulators.

就數據而言，如我所說，我們有三項臨床試驗，將提交給主管機關。前兩項是針對兒科族群。第三項則是針對青少年與成人，其主要終點為六分鐘步行測試，但該試驗也測量許多其他終點；我們已得出結論，該研究具有臨床意義，因此我們將把這些數據提交給監管機構。

Rajan Sharma, Goldman Sachs.

Rajan Sharma，Goldman Sachs。

So just a couple more on Datroway. Just wanted to understand the rationale for adding the QCS biomarker primary endpoint to TL07 and then also including it in TL08. Does this increase the probability of success of the trials in your view? Or is it more about building a moat around the potential patient opportunity given that you have the biomarker?

再問幾個關於 Datroway 的問題。我想了解在 TL07 加入 QCS 生物標記主要終點、並且也納入 TL08 的理由是什麼。在你們看來，這是否提高了試驗成功的機率？或者這更多是為了在你們擁有該生物標記的情況下，圍繞潛在患者機會建立護城河？

And then related to that, is there any reason why control arms across these Datroway lung trials, including AVANZAR, may perform better or worse than you expected in a QCS-positive population specifically?

另外相關地，在這些 Datroway 肺癌試驗（包含 AVANZAR）中，是否有任何原因會使對照組在特定的 QCS 陽性族群中表現比你們預期更好或更差？

Thanks for the question. So in terms of the rationale for including the biomarker in TL07, it's similar to the rationale for including it in AVANZAR based on the totality of data that we've seen so far. Across multiple data sets, we've seen consistent improvement in performance for both PFS and OS in the biomarker-positive patient population, both as monotherapy and in combination with IO in a first-line setting. So that's the logic that says that it makes sense to include in TL07 as well.

謝謝你的問題。關於在 TL07 納入該生物標記的理由，與在 AVANZAR 納入的理由相似，係基於我們迄今所見的整體數據。在多個資料集中，我們看到在生物標記陽性患者族群中，無論是 PFS 或 OS 的表現都有一致性的改善，不論是單藥治療，或在第一線與 IO 聯合治療。因此，這樣的邏輯使得在 TL07 也納入是合理的。

As we did with AVANZAR, our colleagues at Daiichi Sankyo went and approached the regulatory authorities and had discussion about this approach. So similar for TL07, similarly to AVANZAR, there's an opportunity in the ITT and in the biomarker-positive patient population in TL07, which, as a reminder, is in the PD-L1 less than 50% of the patient population.

如同我們在 AVANZAR 所做的，我們在第一三共（Daiichi Sankyo）的同事已與監管機關接洽並就此策略進行討論。因此 TL07 也類似；同樣地，與 AVANZAR 一樣，TL07 在 ITT 以及生物標記陽性患者族群中都有機會；提醒一下，TL07 的族群是 PD-L1 低於 50% 的患者。

I think I've mentioned previously that for TL08, which is in the greater than 50% patient population, given that that's a smaller segment already, the numbers that are accrued in that trial means that it makes sense to only include that as a secondary endpoint and not part of the primary analysis.

我之前提過，TL08 是在 PD-L1 大於 50% 的患者族群；由於那本來就是較小的區隔，加上該試驗的入組人數，因此將其僅作為次要終點、而非主要分析的一部分，是合理的。

But of course, assuming that AVANZAR does show an improvement in the biomarker positive, of course, everybody, including regulators will want to know what the performance is in the biomarker-positive patient population. So I hope that addresses your question about why we're doing it in TL07 and TL08 and why it's different in the statistical analysis in TL07 versus OA.

但當然，假設 AVANZAR 確實顯示生物標記陽性族群有所改善，當然每個人——包括監管機關——都會想知道在生物標記陽性患者族群中的表現如何。所以我希望這能回答你關於為何我們在 TL07 與 TL08 這麼做，以及為何在 TL07 與 OA 的統計分析上有所不同的問題。

In terms of your question about event rate, the event rates for these trials are determined by the event rate in the overall ITT patient population. So whilst it's possible that the patient population that is biomarker positive has a different event rate, that isn't what determines the cut point. So it's really the event rate in the overall population that's determining when we can do the data cutoff and therefore, report the results.

就您關於事件率的問題而言，這些試驗的事件率是由整體 ITT（意向治療）病人族群的事件率所決定。因此，雖然生物標記物陽性的病人族群可能有不同的事件率，但那並不是決定切點（cut point）的因素。所以，真正決定我們何時能進行資料截點（data cutoff）並因此公布結果的，是整體族群的事件率。

And we have no way to predict how the control arm will behave, right? So they have to wait for the end of the study.

而且我們無法預測對照組會如何表現，對吧？所以他們必須等到研究結束。

Michael Leuchten, Jefferies.

Michael Leuchten，Jefferies。

One question maybe too on the delay. So you've got a TL07 delay, just linking back to the last question because of the implementation of QCS. Just wondering if you could talk to how complicated it is to run the test over existing tissue samples and whether that could slip any further or whether that's a firm view on a readout? And then a question on cliramitug, the depleter. There's also the delay here. What's driving that, please?

也許再問一個關於延遲的問題。你們有一個 TL07 的延遲，回扣到上一個問題，是因為導入 QCS。想請你談談在既有的組織樣本上執行該檢測有多複雜，以及是否還可能再延後，或你們對讀出時間點是否有很確定的看法？另外一個問題是關於 cliramitug，也就是那個去除劑（depleter）。這裡也有延遲。請問是什麼原因造成的？

So the timing of the results for TL07, I'll just -- based on the requirements for implementation of the biomarker within the clinical trial, that obviously requires an amendment and there's other aspects of that. We have to actually sort of run the analysis on the samples that are available. There's no further delay to the event rate on TL07.

關於 TL07 結果的時間點，我先說一下——基於在臨床試驗中導入該生物標記物的要求，這顯然需要修訂案（amendment），以及其他相關事項。我們必須實際對可取得的樣本進行分析。TL07 的事件率方面沒有進一步的延遲。

Maybe, Michael, also just one of the maybe questions that's embedded within your question gets to the commercial readiness and how we think about testing in a post-approval world. We've been working really diligently to set up and be ready for QCS across the globe through a combination of central labs but also decentralized testing work that we're doing.

Michael，另外你問題中可能也隱含了一點，涉及商業化準備度，以及我們如何看待核准後世界中的檢測。我們一直非常努力，透過中央實驗室的組合，以及我們正在進行的去中心化檢測工作，來在全球範圍內建立並準備好 QCS。

There's a lot of enthusiasm across regions to incorporate computational pathology into the way in which care is being delivered. And it also gets to the previous question that Rajan asked. I mean, in many respects, you incorporate QCS into these programs because if it works and truly helps select patients, it's very differentiated for the program.

各地區對於將計算病理納入照護提供方式都非常有熱情。這也呼應 Rajan 先前問的問題。我的意思是，在許多方面，你把 QCS 納入這些計畫，是因為如果它有效、且確實有助於選擇病人，對這個計畫而言就具有高度差異化。

Yes. It's a really important point. And we've made that point before, but maybe just to remind you, if you assume that the ITT population will be positive, it's possible to assume that the QCS population might be even more positive in the positive scenario overall, of course. So in the US, we would expect ITT use everywhere. In some countries where payers are more difficult and QCS gives us another chance to get reimbursement if we cannot achieve it in the ITT population. So it's really -- we have two shots on goal in terms of reimbursement. So next question is --

是的。這點非常重要。我們之前也提過，但也許再提醒一下：如果你假設 ITT 族群會呈現正向結果，那麼在整體正向的情境下，也可能合理假設 QCS 族群的正向程度會更高。所以在美國，我們預期 ITT 會在各處使用。在某些國家，付費方較難溝通，而若我們無法在 ITT 族群取得給付，QCS 會讓我們多一次爭取報銷的機會。因此，就報銷而言，我們等於有兩次射門機會。所以下一個問題是--

So first of all, the -- just remind you that cliramitug is not an event-based trial, but a time-bound trial. And as the trial recruited faster than we expected, in order to reach the target medium exposure of the trial, we decided to extend the study by six months. It's not an event-based, but we wanted to return to the targeted medium exposure.

首先——提醒一下，cliramitug 不是事件驅動型試驗，而是時間界定（time-bound）的試驗。由於試驗招募速度比我們預期更快，為了達到試驗目標的中位暴露時間（median exposure），我們決定將研究延長六個月。它不是事件驅動型，但我們希望回到目標的中位暴露時間。

Matt Weston, UBS.

Matt Weston，UBS。

Two questions, please, if I can, on eplontersen. The first is now that tafamidis generics are delayed to 2031. If the combo is superior in CARDIO-TTRansform, is it realistic to expect reimbursement of a double-branded regimen in that setting?

如果可以的話，兩個問題，關於 eplontersen。第一個是，既然 tafamidis 學名藥延後到 2031 年。如果在 CARDIO-TTRansform 中，聯合療法更優，是否現實上能期待在該情境下對「雙品牌」療程給付？

And then the second question is around Wainua in ATTR-PN. One of your other differentiations potentially is going to be the home administration claim in the US. So can you update us on the commercial performance in the US market in the PN setting so we can understand how advantageous home administration really is?

第二個問題是關於 Wainua 在 ATTR-PN。你們另一個可能的差異化點將是美國的居家給藥主張。能否更新一下在美國市場、PN 適應症情境下的商業表現，讓我們理解居家給藥到底有多大的優勢？

Yes. Thank you, Matthew, for both questions. First of all, regarding the combination, of course, it fully depends in my view and our view on the size of the effect if the effect size is very, very substantial. I truly believe that payers certainly in the United States will be open to reimburse both branded products for this debilitating disease. So let's not forget that the mortality rate of patients with ATTR-CM is very high.

是的。Matthew，謝謝你這兩個問題。首先，關於聯合療法，當然在我看來、也在我們看來，完全取決於效果幅度；如果效果量非常、非常顯著，我確實相信付費方——尤其在美國——會願意為這種致殘性疾病同時給付兩個品牌藥品。別忘了，ATTR-CM 病人的死亡率非常高。

So once again, if the trial is going to show a very substantial benefit for the combination, I believe that the payers, the reimbursement authorities will certainly consider this for -- in order to reimburse it.

所以再說一次，如果試驗顯示聯合療法有非常顯著的效益，我相信付費方、給付主管機關一定會將其納入考量——以便予以給付。

Regarding the PN indication, I think overall, we are quite happy how it goes. It's very encouraging. There are a lot of patients with a so-called mixed phenotype certainly in the United States. Of course, with the registration of the competitor also in the CN trial, there's not always to capture all those patients. But if you look at pure PN patients. We are clearly, clearly leading the pack here.

至於 PN 適應症，我想整體而言，我們對進展相當滿意。這非常令人鼓舞。在美國確實有很多所謂「混合表型」的病人。當然，隨著競品也在 CN 試驗中取得核准，並不總是能涵蓋到所有這些病人。但如果你看的是純 PN 病人，我們在這裡明顯、明顯領先同業。

You are mentioning the home administration. For many patients, that's an ideal way in order to get the medicine because there's no need to go at least four times a year to a hospital in order to get the drug administered by the physician. So I think the combination of a higher quality of life or a better quality of life, home administration and a very strong efficacy in general, I think, is one of the reasons we see a very strong uptake in the United States and other countries for the PN indication.

你提到居家給藥。對許多病人而言，這是取得藥物的理想方式，因為至少不需要一年四次到醫院，由醫師施打藥物。所以我認為，更高或更好的生活品質、居家給藥，以及整體非常強的療效三者的結合，是我們在美國及其他國家於 PN 適應症看到非常強勁採用率的原因之一。

Peter Verdult, Exane.

Peter Verdult，Exane。

Peter here from BNP. Just Sharon and Ruud, could we come back to tozo quickly. Sorry to labor the point, but just coming at a different angle, I just wanted to explore maybe potential upside scenarios to your $3 billion to $5 billion peak sales assumption. So are you assuming that you will see IL-33 competition or competitors eventually making it to the market when you provide that peak sales target?

我是 BNP 的 Peter。Sharon 和 Ruud，我們能否快速回到 tozo？抱歉再追問，但我想從不同角度探討一下，你們對 30 億到 50 億美元峰值銷售假設可能的上行情境。所以，當你們提出該峰值銷售目標時，是否假設最終會看到 IL-33 的競爭或競品進入市場？

And do you have any plans to explore tozo beyond COPD or lower tract respiratory disease? I'm thinking maybe nasal polyps or bronchiectasis. And then just a quick clarification, Sharon, just on the PROSPERO question earlier. Am I right in thinking that the endpoint there was a bit different to OBERON (inaudible)?

另外，你們是否有計畫將 tozo 的探索延伸到 COPD 或下呼吸道疾病之外？我想到的可能是鼻息肉或支氣管擴張症。最後再快速釐清一下，Sharon，關於先前 PROSPERO 的問題。我理解那裡的終點與 OBERON 有些不同，對嗎(聽不清楚)？

Thank you, Peter. So Sharon, do you want to start with the second one and then Ruud, you can cover the first one?

謝謝你，Peter。Sharon，你要不要先回答第二個，然後 Ruud 你再回答第一個？

Sure. Yes. So you're spot on. The endpoint for PROSPERO was different than for OBERON and TITANIA. In PROSPERO, we specifically looked at selectively severe exacerbations, which is different than TITANIA that looked at moderate to severe exacerbations.

當然。是的。你說得完全正確。PROSPERO 的終點與 OBERON 和 TITANIA 不同。在 PROSPERO 中，我們特別看的是選擇性的嚴重惡化（severe exacerbations），這不同於 TITANIA 所看的中度到重度惡化（moderate to severe exacerbations）。

The overall trial population that we enrolled in our comprehensive LUNA program is different from what competitor molecules did, and it really provides us with a point of differentiation for tozorakimab. We have a differentiated molecule in terms of its bifunctional inhibition, and we also have a differentiated clinical trial program. Ruud, would you like to take the rest?

我們在全面性的 LUNA 計畫中所納入的整體試驗族群，與競品分子所採用的族群不同，這確實為 tozorakimab 提供了差異化的切入點。我們的分子在雙功能抑制方面具備差異化，我們也擁有差異化的臨床試驗計畫。Ruud，你願意接著說完剩下的部分嗎？

Yes, of course. So first of all, Peter, we have indicated once again that this product in our view, is a $3 billion to $5 billion opportunity in COPD alone. Of course, the competitive environment has changed somewhat, and we don't know exactly what they are going to do moving forward.

是的，當然。首先，Peter，我們再次指出，依我們的看法，單就 COPD 而言，這個產品是一個 30 億到 50 億美元的機會。當然，競爭環境已有些變化，而我們也不確定他們接下來會怎麼做。

Now having said that, based on the results, of course, we are also thinking about potential other indications. You are mentioning bronchiectasis, potentially, asthma. We haven't taken any decision yet on that. But if everything moves well, of course, we will have a look whether it makes sense also to move tozorakimab in other indications where there's still a high unmet medical need.

話雖如此，基於這些結果，當然我們也在思考其他潛在適應症。你提到支氣管擴張症，可能還有氣喘。我們尚未就此做出任何決定。但如果一切進展順利，當然我們會評估是否也有意義將 tozorakimab 推進到其他仍存在高度未被滿足醫療需求的適應症。

On top of that, overall, the bio penetration of the current biologics in COPD is still relatively limited. It is below the 10%. So it also shows the potential in COPD, which is a very heterogeneous disease in order to use a completely new biologic specifically designed for COPD in order to capture the full potential in COPD.

此外，整體而言，目前生物製劑在 COPD 的滲透率仍相對有限。低於 10%。這也顯示 COPD 的潛力——這是一種非常異質性的疾病——因此使用一個專為 COPD 設計、全新的生物製劑，以在 COPD 中充分釋放其全部潛力。

Christopher Uhde, SEB.

Christopher Uhde，SEB。

So my first is on MFN, if you wouldn't mind commenting. So how are you forecasting the future impact, let's say, across the seven major markets? Or how would you recommend we do it perhaps is the question you'll answer? And then is this for -- should we be thinking about it applying to only future launches as some of the competitors have said?

我第一個問題是關於 MFN，如果你不介意評論一下。你們如何預測未來的影響，例如在七大主要市場的影響？或者你們會建議我們應該怎麼做預測——也許這才是你會回答的問題？另外，這是否——我們是否應該認為它只適用於未來上市的新產品，正如一些競爭對手所說的那樣？

And then on IL-5, we've got a competing long-acting IL-5 that's launched and tracking rapid growth. So Ruud, what are you seeing on the competition? What are your thoughts then on the long-term future? I guess that part is for Sharon of the role of IL-5 in the R&I therapeutic area? And how are you working to adapt to play a key part in that going forward?

接著關於 IL-5，我們看到一個競爭性的長效 IL-5 已經上市，且成長迅速。所以 Ruud，你在競爭方面看到了什麼？你對長期未來有何看法？我想那部分是給 Sharon 的：IL-5 在 R&I 治療領域中的角色是什麼？以及你們如何調整以在未來持續扮演關鍵角色？

Yes. Let me take the first one or the second one, sorry, the IL-5. Yes, first of all, we are very pleased with the performance now for quite some time of Fasenra. It's clearly the leading anti-IL-5 in the class. I think the EGPA launch in countries like Japan, United States have been very successful. Equally, of course, the class is changing somewhat. It's now a long-acting anti-IL-5.

是的。我先回答第一個——或第二個，抱歉，是 IL-5 的問題。是的，首先，我們對 Fasenra 這段時間以來的表現感到非常滿意。它顯然是同類中領先的抗 IL-5 產品。我認為在日本、美國等國家的 EGPA 上市非常成功。同樣地，當然，這個類別也在某種程度上發生變化。現在出現了長效型抗 IL-5。

Now having said that, the NIMBLE study was not specifically successful regarding the switch from Fasenra IL-5 to the long-acting one. It was even getting worse. So I think what we need to do is to cement our position as the leading IL-5. I think the molecule is doing extremely well. I think the mode of action, we sometimes forget that is fundamentally different from the other anti-IL-5. We are depleting eosinophils -- and we have seen very, very strong traction across the world.

話雖如此，NIMBLE 研究在從 Fasenra IL-5 轉換到長效型產品方面並未特別成功。甚至變得更糟。因此我認為我們需要做的是鞏固我們作為領先 IL-5 的地位。我認為這個分子表現非常出色。我認為其作用機轉，我們有時會忘記，它與其他抗 IL-5 在根本上是不同的。我們是在耗竭嗜酸性球——而且我們已在全球看到非常、非常強勁的採用動能。

And there's no reason to believe that, that will not continue. And last but not least, what I said in my prepared remarks, we have just launched Fasenra in China. China, there's a high unmet medical need and the potential of Fasenra in China is very, very substantial as well.

沒有理由相信這種趨勢不會持續。最後但同樣重要的是，正如我在事先準備的發言中提到的，我們剛在中國推出 Fasenra。中國存在高度未被滿足的醫療需求，而 Fasenra 在中國的潛力也非常、非常可觀。

Sure. So building on that, Ruud, I'll just restate that we have a lot of faith in Fasenra. It's a fantastic molecule. It provides targeted complete and fast sustained eosinophil removal, effectively treating EOS inflammation and reducing the risk for patients. We've got a winner in Fasenra. And we have an eight-week dosing regimen that delivers that sustained control and really stands out for its high adherence.

當然。在此基礎上，Ruud，我再重申一次，我們對 Fasenra 非常有信心。這是一個非常出色的分子。它可提供具標靶性的、完全且快速且持續的嗜酸性球清除，有效治療 EOS 發炎並降低病人風險。Fasenra 是我們的致勝產品。而且我們有每 8 週一次的給藥方案，能帶來持續控制，並且因高依從性而真正脫穎而出。

We've got about 80% to 90% of patients remaining on Fasenra through our pivotal studies, which is really remarkable as well as in our real-world studies. And it remains the only biologic with clinical evidence proven to reduce for both oral and inhaled background therapy. So we've got a strong molecule there.

在我們的關鍵性研究中，大約有 80% 到 90% 的病人持續使用 Fasenra，這在我們的真實世界研究中同樣非常顯著。而且它仍是唯一一個有臨床證據證明可同時降低口服與吸入背景治療需求的生物製劑。因此我們擁有一個很強的分子。

As we think about future growth in the portfolio, building on our success in Fasenra is part of our early strategy. I won't comment further on molecules that sit in our discovery pipeline, but we think about how to continue to leverage the success that we've seen in this program.

當我們思考產品組合的未來成長時，在 Fasenra 的成功基礎上持續發展，是我們早期策略的一部分。我不會進一步評論我們探索性研發管線中的分子，但我們會思考如何持續運用我們在這個計畫中看到的成功。

So the first question, I mean, you can take a very conservative approach and remove the 7 plus -- G7 -- I mean G7 being six countries and two from the forecast, if you want a very, very conservative approach. knowing that the last two are smaller markets. But we are working very hard, not only we, but the whole industry to improve the access and pricing environment in all of those countries.

至於第一個問題，我的意思是，如果你想採取非常保守的做法，你可以把 7 加——G7——也就是六個國家再加上兩個——從預測中移除，前提是你想要非常、非常保守的做法，並且知道最後兩個是較小的市場。但我們正在非常努力地工作，不僅是我們，整個產業也在努力改善所有這些國家的可近性與定價環境。

I should remind you all that it's only for new products, future new products. And it will also be different product by product, country by country in terms of what is the gap between the GDP per capita adjusted price in that country versus the US. But ultimately, our goal is to launch those products in every single market and improve the access environment.

我也要提醒各位，這只適用於新產品、未來的新產品。而且在各國、各產品之間也會有所不同，取決於該國以人均 GDP 調整後的價格與美國之間的差距。但最終，我們的目標是在每一個市場推出這些產品，並改善可近性環境。

We have time to do this because new products will not be launched immediately. You've seen some movements in the UK already, discussions based on the 301 investigation will start with other countries, I think, in the next few weeks or months. We are ourselves in the whole industry talking to countries and explaining the importance of improved access, not only for patients, but also for investments in R&D and in particular, in R&D in their respective countries.

我們有時間來做這件事，因為新產品不會立刻上市。你已經看到英國方面有一些動作；基於 301 調查的討論，我認為在接下來幾週或幾個月也會與其他國家展開。我們自己以及整個產業都在與各國溝通，並說明改善可近性的重要性，不僅對病人，也對研發投資，特別是對其各自國家的研發投資。

And we are getting positive response in some countries and more wait and see in other countries. But we have it -- this is going to play out over the next 18 months, 2 years. So we have time to hopefully reshape the environment. So I've given you the most conservative approach in terms of forecasting, but I don't think it's going to be like this.

我們在一些國家得到正面回應，而在其他國家則較偏向觀望。但我們——這將在未來 18 個月到 2 年內逐步發展。因此我們有時間希望能重塑這個環境。所以我已提供你在預測方面最保守的做法，但我不認為最後會是那樣。

And as it is today, you have to remember, the whole of Europe represents 20% of our global sales. So take a fragment out of this. This is not huge. And so we truly hope we are going to get better pricing and better access and be able to launch our products everywhere, which is, of course, the ultimate goal.

而且以目前情況來看，你必須記得，整個歐洲僅占我們全球銷售的 20%。所以從中拿掉一小部分。這並不大。因此我們真心希望能取得更好的定價與更好的可近性，並能在各地推出我們的產品，這當然是最終目標。

Seamus Fernandez, Guggenheim.

Seamus Fernandez，Guggenheim。

Thanks, Pascal. So our question is actually on the positioning of the GLP-1 and how you're thinking about that. So can you maybe just walk us through how the upcoming ADA is really going to help us fully derisk your strategy in this space? Maybe help us understand the safety supporting the aggressive advancement into Phase III?

謝謝，Pascal。所以我們的問題其實是關於 GLP-1 的定位，以及你們對此的思考。那你能否帶我們梳理一下，即將到來的 ADA 將如何真正幫助我們把你們在這個領域的策略風險充分降低？也許也幫助我們理解，支持你們積極推進到第三期的安全性依據？

And maybe if you could just specifically comment on whether these data are likely to convince investors that product half-life is key to differentiation on tolerability over and above planned titration scheme. So just trying to get an understanding of how these data coming at ADA are really going to wrap around the very broad Phase III program that you've initiated.

另外，也請你特別評論一下，這些數據是否可能說服投資人：相較於既定的劑量遞增（titration）方案，產品半衰期才是耐受性差異化的關鍵。所以我們只是想了解，ADA 公布的這些數據將如何與你們已啟動、非常廣泛的第三期計畫相互呼應。

Thank you, Seamus. This one is for Sharon. And maybe Ruud, you can also jump in. I just want to be clear, fully derisk is a bit ambitious. We will fully derisk when we are at the end of the Phase III program, where we are moving as fast as we can into Phase III. So over to you, Sharon.

謝謝你，Seamus。這題給 Sharon。Ruud，你也可以補充。我想先說清楚，「完全去風險」有點過於雄心勃勃。我們會在第三期計畫結束時才算真正完全去風險；目前我們正以最快速度推進到第三期。那交給你了，Sharon。

Yes. Thank you for the question, Seamus. As you know, those data are upcoming at ADA in June. So I cannot tell you what the data say, the conference organizers would frown on that. But we did announce that we completed the Phase IIb trials for elecoglipron and that the data that we saw in those Phase IIb trials, one for obesity and one for patients with type 2 diabetes, gave us the confidence that we need to move into a very comprehensive Phase III development program.

是的。謝謝你的提問，Seamus。如你所知，這些數據將在 6 月的 ADA 公布。所以我不能告訴你數據內容，會議主辦方不會樂見這樣做。但我們確實已宣布完成 elecoglipron 的第二期 b 試驗，而我們在這些第二期 b 試驗（一項針對肥胖、一項針對第二型糖尿病患者）中看到的數據，給了我們所需的信心，讓我們能夠進入一個非常全面的第三期開發計畫。

We have dual goals there. We're looking at both weight loss efficacy, and we're also looking at outcome benefits, which are key drivers for us because we are focused not solely on weight loss, but on being able to address complex interrelated comorbidities. And AstraZeneca is in a unique position with our broad portfolio.

我們在那裡有雙重目標。我們同時關注減重療效，也關注結局（outcome）獲益；這些是我們的關鍵驅動因素，因為我們的重點不僅是減重，而是能夠處理複雜且相互關聯的共病。而阿斯特捷利康憑藉我們廣泛的產品組合，處於獨特的位置。

We are ideally suited to creating both monotherapies and fixed-dose combinations with elecoglipron that allow us to address comorbid disease. So at ADA, we look forward to sharing the data and continuing this conversation. But what we saw in those data gave us the confidence that we needed to fully invest in our comprehensive program.

我們非常適合以 elecoglipron 打造單藥治療與固定劑量複方，讓我們能夠處理共病疾病。因此在 ADA，我們期待分享數據並延續這段對話。但我們在那些數據中看到的結果，給了我們所需的信心，讓我們能夠對這個全面計畫進行全力投入。

No, there's not a lot to add what Sharon has said. I think the focus on outcomes, I think our strength with fixed-dose combinations, and we have articulated a few of those potential combinations. And one of them is clearly with our SGLT2 Farxiga. And last but not least, I think also AstraZeneca is quite uniquely positioned regarding our global footprint. We have a very strong presence, as we all know, in the international markets and there's still an incredible high unmet medical need in those markets regarding obesity treatment, but clearly also diabetes.

沒有太多要補充 Sharon 已說的內容。我認為重點在於結局；也在於我們在固定劑量複方方面的優勢，而且我們已闡述了幾個潛在的組合。其中之一很明確是與我們的 SGLT2 藥物 Farxiga 的組合。最後但同樣重要的是，我也認為阿斯特捷利康在全球佈局方面具有相當獨特的優勢。我們在國際市場有非常強的存在感，眾所周知，這些市場在肥胖治療方面仍有極高的未滿足醫療需求，當然糖尿病也是如此。

We have a very ambitious Phase III program that is excellent really. The team has done an amazing job. And so we have a very, very strong data set, assuming, of course, the studies are positive, which we believe we have a good chance for that, of course, but we will have a very strong set of data across a very broad Phase III program to launch this product.

我們有一個非常雄心勃勃、而且確實非常出色的第三期計畫。團隊做得非常好。因此，假設研究結果為正向——我們當然相信有很大機會如此——我們將在一個非常廣泛的第三期計畫中累積一套非常強而有力的數據，用於這個產品的上市。

Luisa Hector, Berenberg.

Luisa Hector，Berenberg。

Thank you, Pascal. A couple, please. So on camizestrant, are there interim analyses still pending for the CAMBRIA's or even SERENA-4? And then given that we've had some discussion on Phase III trials, which are in flight, but you've been making some changes such as TL07, 08.

謝謝，Pascal。我有幾個問題。關於 camizestrant，CAMBRIA 系列或甚至 SERENA-4 是否仍有期中分析尚待公布？另外，鑑於我們已討論到正在進行中的第三期試驗，但你們也做了一些變更，例如 TL07、08。

I wonder whether you could give us some more color around your work with the FDA on real-time clinical trials because I see Astra mentioned as one of two companies working with the FDA there. So what kind of benefits could this ultimately bring in terms of timing and savings?

我想知道你們是否能更具體說明與 FDA 在即時臨床試驗方面的合作，因為我看到阿斯特捷利康被提及為與 FDA 合作的兩家公司之一。那麼，這最終在時程與成本節省方面，可能帶來哪些好處？

I think, Susan this for you. The question is really a real-time collaboration -- study collaboration with FDA.

我想這題給 Susan。問題主要是與 FDA 的即時合作——研究層面的合作。

Yes, sure. Thanks for the question, Luisa. So for interim analysis, you know we don't comment on those. So I can't really address that question anymore. For the real-time clinical trials, I think this is an exciting first step towards this future. So the trial that we are collaborating with the FDA on is the TrAVeRse trial, which is with a well-established medicine, acalabrutinib in a mantle cell lymphoma setting.

好的，當然。謝謝你的問題，Luisa。關於期中分析，你知道我們不會評論這些。所以我無法再進一步回答那個問題。至於即時臨床試驗，我認為這是邁向未來的一個令人振奮的第一步。我們與 FDA 合作的試驗是 TrAVeRse 試驗，使用的是一個已相當成熟的藥物 acalabrutinib，適應症是在套細胞淋巴瘤的治療情境。

So what this enables us to do is literally to -- as the adverse events and the things come in, we'll get notified simultaneously with the FDA. So I think this will enable us to have learnings. I think the opportunity, though, is in a future world where you're not submitting based on documents, but you are submitting based on access to data. This could save time in terms of preparation for submissions and also time from the regulatory side in review of those submissions because the various analyses can be done.

這讓我們能做的是——字面上——當不良事件等資訊進來時，我們會與 FDA 同步收到通知。所以我認為這將使我們能夠獲得學習。不過，我認為真正的機會在於未來的世界：你不是以文件為基礎提交，而是以資料存取為基礎提交。這可以在申報準備上節省時間，也能在法規端審查申報時節省時間，因為各種分析都可以完成。

And then you can spend more time on the discussions with the agency about the context and the relevance of the data and the impact that that's going to have on treatment outcomes. So the hope is that this will lay the groundwork for that collaboration, and we're very happy to be partnering with the FDA in that regard and at the forefront of learning here.

然後你就能把更多時間用在與主管機關討論數據的背景與相關性，以及這將如何影響治療結局。所以我們希望這能為那樣的合作奠定基礎；我們也很高興能在這方面與 FDA 合作，並站在學習的最前沿。

Mattias Haggblom, Handelsbanken.

Mattias Haggblom，Handelsbanken。

One question, please. Can you talk about CAR-T and specifically how you feel about the Gracell BCMA CAR-T program, but also Gracell's FasTCAR as a platform in light of industry's rapidly growing interest (technical difficulty)

一個問題。你能談談 CAR-T，特別是你們如何看待 Gracell 的 BCMA CAR-T 計畫，以及在產業對此快速升溫的興趣之下，Gracell 的 FasTCAR 作為平台的意義嗎（技術問題）

So the line was not very good, Mattias, but hopefully, Susan, you got it. It's about AZD0120, but I'm not sure that --

Mattias，你的線路不是很好，但希望 Susan 你有聽到。是關於 AZD0120，但我不確定--

I just want to clarify the question a little bit. I think you were asking about how the FasTCAR process helps the differentiation of AZD0120, the lead product. Did I get that right?

我想先把問題釐清一下。我理解你是在問 FasTCAR 製程如何幫助 AZD0120（主力產品）做出差異化。我理解得對嗎？

I can't hear the answer. So I'll answer what I thought the question was.

我聽不到回答。所以我就針對我以為的問題來回答。

So one of the differentiations of AZD0120 is that it's developed with this FasTCAR process, which enables the ex vivo growth of the cells in a 3-day process, which means that you can get a turnaround time reliably in around a 16-day time frame, because after the cells have been produced, there's still some quality testing that needs to be done before the cells are shipped to the patient. That reliable and shorter delivery time is really important for sites and for the operationalization.

AZD0120 的差異化之一，是它採用 FasTCAR 製程開發；該製程可在體外（ex vivo）以 3 天完成細胞增殖流程，這表示你可以在大約 16 天的時間範圍內，可靠地完成周轉時間，因為細胞製備完成後，在將細胞運送給病人之前，仍需要進行一些品質檢測。這種可靠且更短的交付時間，對於各治療中心以及作業落地（operationalization）而言非常重要。

But there are other factors that are involved in here as well. You end up giving a lower dose and you give a lower dose of fitter T cells, then it can then expand in the patient's body, in vivo more rapidly. What that also delivers is a predictable time of onset of any cytokine release syndrome and enable it to be positioned as a potentially outpatient treatment because people know what the timing of the cytokine release syndrome is can be prepared for that and then the patient can go back after that period of time.

但這裡也牽涉到其他因素。當你最終給予較低劑量，且給予較低劑量、狀態更佳的 T 細胞時，它就能在患者體內（in vivo）更快速地擴增。這也帶來了細胞激素釋放症候群（CRS）發作時間的可預測性，並使其有機會被定位為潛在的門診治療，因為大家知道 CRS 的時間點，就能事先做好準備，之後患者在那段時間過後即可返家。

So it's not just the FasTCAR process in itself. It also is the dose that you end up with and the timing of the CRS that also make it differentiated. I think the other factor, of course, is that it's a dual CAR. It's got CD19 and BCMA targeting. We think that's important for avoidance of the escape mechanisms from downregulation of one target or the other.

所以不只是 FasTCAR 製程本身。最終的劑量以及 CRS 的發生時點，也讓它具備差異化。我認為另一個因素當然是它是雙 CAR。它同時鎖定 CD19 與 BCMA。我們認為這對於避免因其中一個靶點或另一個靶點下調所造成的逃逸機制很重要。

So overall, we're delighted with the profile that we've got with 120. It was presented in detail at the ASH meeting, and we now have ongoing DURGA-4 study, Phase III study in later line multiple myeloma, and you'll see further studies in the coming months as we open up this program more broadly.

總體而言，我們對 120 所呈現的特徵非常滿意。它已在 ASH 年會上做了詳細發表，而我們目前也有正在進行的 DURGA-4 研究，這是一項針對後線多發性骨髓瘤的第三期研究；未來幾個月，隨著我們更廣泛地推進此計畫，你們也會看到更多研究。

Simon Baker, Redburn.

Simon Baker，Redburn。

Just one for me, if I may, please, for Dave. I was wondering if you could give us an idea of the underlying demand growth for Tagrisso. As you said, it was distorted by wholesaler destocking. And related to that, is that wholesaler destocking specific to Tagrisso? Or are you seeing that anywhere else in the portfolio?

我這邊只有一個問題，如果可以的話，想請教 Dave。我想知道你是否能給我們一個對 Tagrisso 基礎需求成長的概念。如你所說，它受到批發商去庫存的扭曲。另外相關地，這個批發商去庫存是 Tagrisso 特有的嗎？還是你們在產品組合的其他地方也有看到？

Thanks, Simon, for the question. Just within the US, we have really seen Tagrisso with strong frontline leadership, just to build and quantify some of the comments that I made in the prepared remarks. The demand growth for the quarter for Tagrisso was mid-teens. And so you can see that the really truly and higher than historical destocking levels is what brought the net results down to where they were.

謝謝你，Simon，這個問題。就美國而言，我們確實看到 Tagrisso 在一線治療上維持強勢領導地位；為了補充並量化我在事先準備的發言中提到的一些評論。本季 Tagrisso 的需求成長約為十幾個百分點（mid-teens）。因此你可以看到，真正且高於歷史水準的去庫存幅度，才是把淨結果拉低到目前水準的原因。

Now specific to your question, we have seen some suggestion of this on other orals, but it didn't include Calquence that could be because of a buildup for AMPLIFY. So not entirely sure. But we are seeing some destocking across the oral agents that's taking place, but it was particularly noteworthy on Tagrisso.

針對你具體的問題，我們在其他口服藥物上也看到一些這樣的跡象，但不包括 Calquence，這可能是因為為 AMPLIFY 做庫存建立。所以不完全確定。但我們確實看到口服藥物整體出現一些去庫存的情況，不過在 Tagrisso 上特別明顯。

I think the most important piece, though, is that I don't see that going any further down. The demand growth is very strong. We're seeing a clear preference for FLAURA-2. Very importantly, on MARIPOSA, we have not seen any impact from the subcutaneous launch on US Tagrisso shares. So the subcutaneous launch is cannibalizing IV, but it is not having impact on Tagrisso shares. And by the way, that same is true in Germany and in Japan.

不過我認為最重要的是，我不認為這還會再進一步下滑。需求成長非常強勁。我們看到對 FLAURA-2 有明顯偏好。非常重要的是，就 MARIPOSA 而言，我們沒有看到皮下注射上市對美國 Tagrisso 市占造成任何影響。所以皮下注射上市是在侵蝕靜脈注射（IV），但並未影響 Tagrisso 的市占。順帶一提，德國與日本也是同樣情況。

Justin Smith, Bernstein.

Justin Smith，Bernstein。

I've got one for Ruud. Ruud, if I remember correctly, during the August call last year post ESC baxdrostat, you said it could be above $5 billion, it could be above $10 billion, time would tell. Just wondered over six months on for that, if those remarks are the same or if you would qualify those remarks at all.

我有一個問題想問 Ruud。Ruud，如果我沒記錯，去年 8 月那次電話會議在 ESC baxdrostat 之後，你說它可能超過 50 億美元，也可能超過 100 億美元，時間會告訴我們。想請問過了六個月後，你的看法是否仍然相同，或你會對那些說法做任何修正？

Yes. No, I think they are still the same. So once again, what we have indicated during the Investor Day that this is potentially a $5 billion asset. Let's not forget that we're investigating and the $5 billion is built roughly half of that is in the fixed-dose combination. That study will read out beyond 2027.

是的。不，我認為仍然相同。所以再一次，我們在投資人日所指出的是，這可能是一個 50 億美元級別的資產。別忘了我們正在研究，而這 50 億美元的估算中，大約一半來自固定劑量複方（fixed-dose combination）。那項研究將在 2027 年之後讀出結果。

And the other one is the mono component, but we are also looking into CKD for baxdrostat. So there are four other indications, which potentially, if successful, can move that number up to potentially 10 billion, and that view hasn't changed at all.

另一部分是單藥（mono）成分，但我們也在評估 baxdrostat 用於慢性腎臟病（CKD）。因此還有另外四個適應症，若成功，可能把這個數字提高到潛在的 100 億美元，而這個觀點完全沒有改變。

Very good. Let's hand on that, Justin. You're making Ruud nervous. We're moving into budget timing. Baxdrostat is definitely a big product, and we're all excited to see it launch in many countries very soon.

非常好。那就到這裡吧，Justin。你讓 Ruud 緊張了。我們要進入預算時程了。Baxdrostat 絕對是一個大產品，我們也都很期待它很快在許多國家上市。

So thank you, everybody. Thank you for your great questions and for your interest in our company, and we wish you a good rest of the day.

所以謝謝各位。感謝你們提出很棒的問題，以及對我們公司的關注，祝各位今天剩下的時間愉快。