葛蘭素史克 (GSK) 2025 Q4 法說會逐字稿

完整原文

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

  • Operator

    Operator

  • Ladies and gentlemen, a warm welcome to the GSK full year 2025 results call. I'm delighted to be joined today by Luke Myles, Nina Mojas, Deborah Waterhouse, Tony Wood, and Julie Brown. And in our Q&A session, we will be joined by David Redfern. Today's call will last approximately one hour with the presentation taking around 30 minutes and the remaining time for your questions. (Operator Instructions)

    女士們、先生們,熱烈歡迎參加葛蘭素史克2025年全年業績電話會議。今天我很高興能與盧克·邁爾斯、妮娜·莫哈斯、黛博拉·沃特豪斯、托尼·伍德和朱莉·布朗一起參與討論。在我們的問答環節,我們將邀請到大衛·雷德芬。今天的電話會議將持續約一小時,其中演示時間約 30 分鐘,剩餘時間供您提問。(操作說明)

  • Before we start, please turn to slide 3. This is the usual Safe Harbor statement. We will comment on our performance using constant exchange rates, or CER, unless otherwise stated.

    開始之前,請翻到第3張投影片。這是常見的安全港聲明。除非另有說明,否則我們將使用固定匯率(CER)對我們的業績進行評論。

  • I will now hand over to Luke.

    現在我將把麥克風交給盧克。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Thank you, and welcome, everyone. My introduction today will have two parts: headline results for 2025 and our key focus areas in 2026 to drive value.

    謝謝大家,歡迎各位。我今天的介紹將分為兩部分:2025 年的主要成果以及我們在 2026 年為創造價值而重點關注的領域。

  • Starting with 2025, results were strong. Sales were up 7% to more than GBP32 billion. Growth was driven by Specialty Medicines, which were up 17%, with vaccines also contributing. Core operating profit grew 11%, and EPS was up 12%. Cash generation was strong at GBP8.9 billion, supporting future investment and returns to shareholders, enabling the dividend upgrade of 2p to 66p declared today.

    從 2025 年開始,結果非常強勁。銷售額成長7%,超過320億英鎊。成長主要由特藥推動,特藥成長了 17%,疫苗也做出了貢獻。核心營業利潤成長11%,每股收益成長12%。該公司現金流強勁,達到 89 億英鎊,為未來的投資和股東回報提供了支持,因此今天宣布將股息提高 2 便士至 66 便士。

  • R&D output remained very positive, with five FDA approvals and seven new pivotal trial starts, and we maintained our high standards for being a responsible business. Looking forward, we expect another year of profitable growth, reflected in the guidance given today.

    研發成果依然非常積極,獲得了 5 項 FDA 批准,並啟動了 7 項新的關鍵性試驗,我們保持了作為負責任的企業的高標準。展望未來,我們預計將迎來獲利成長的一年,這已體現在我們今天發布的業績指引中。

  • Next slide, please. In 2026, we expect momentum to continue, and we'll get there by focusing on execution and operational delivery. There are three areas where we're focused. The first is driving top-line growth by maximizing launch products like Blenrep and Extensa and ensuring success in overall operational execution.

    請看下一張投影片。我們預計2026年發展動能將持續,而實現這一目標的關鍵在於專注於執行和營運交付。我們重點關註三個方面。首先是透過最大化推廣Blenrep和Extensa等上市產品,並確保整體營運執行的成功,從而推動營收成長。

  • Second, accelerating key assets in our late-stage portfolio like B7-H3, B7-H4, and Velsatinib in oncology, and Effi in MASH, and in our earlier portfolio, like the ultra-long-acting TSLP for respiratory diseases and regimen selection for our six-monthly treatment for HIV.

    其次,加速推進我們後期產品組合中的關鍵資產,例如腫瘤領域的 B7-H3、B7-H4 和 Velsatinib,以及 MASH 領域的 Effi,以及我們早期產品組合中的關鍵資產,例如用於治療呼吸系統疾病的超長效 TSLP,以及我們每六個月一次的 HIV 治療方案的選擇。

  • Third, continue to execute business development, where we see a clear pathway to value creation, and our recent addition of the food allergy IgE antibody, Ozuriquimab, is consistent with this. Underpinning this will be a drive to simplify how we work with greater pace, accountability, and focus. This starts by matching our best people and resources to the best opportunities to create value.

    第三,繼續推動業務發展,我們看到了創造價值的明確途徑,我們最近新增的食物過敏 IgE 抗體 Ozuriquimab 就與此相符。我們將致力於簡化工作流程,提高工作效率、責任感和專注度。首先,我們要將最優秀的人才和資源與創造價值的最佳機會相匹配。

  • Linked to this, changes have already been made to the executive team, bringing on commercial leaders with deep industry experience to increase our focus on products and execution, and this includes Nina Mojas, our new Head of Global Product Strategy, who I worked with for a number of years at AstraZeneca and Roche, who will present the commercial update. Importantly, we'll have an increased focus on leveraging practical use of AI and technology.

    同時,公司高階主管團隊已經進行了調整,引入了具有深厚行業經驗的商業領袖,以加強我們對產品和執行的關注。其中包括我們新的全球產品策略負責人 Nina Mojas,我曾在阿斯特捷利康和羅氏與她共事多年,她將介紹最新的商業進展。重要的是,我們將更加重視人工智慧和技術的實際應用。

  • I'll now hand over to Nina.

    現在我將把麥克風交給妮娜。

  • Nina Mojas - President, Global Product Strategy

    Nina Mojas - President, Global Product Strategy

  • Thanks, Luke. Please turn to the next slide. Overall sales for the year were up 7%, with strong growth driven by Specialty, up 17%, and another year of growth in all regions.

    謝謝你,盧克。請翻到下一張投影片。全年總銷售額成長 7%,其中特種產品成長強勁,達到 17%,所有地區連續第二年成長。

  • Next slide, please. Respiratory immunology and inflammation, full-year sales were up 18%, driven by strong Benlysta and Nucala performance. In the year, Benlysta grew 22%, driven by higher demand and supported by all major guidelines. 82% of US bio-naive patients are now starting on Benlysta due to its differentiated profile with organ damage prevention and more than 14 years of safety and experience. Nucala grew 15% and delivered GBP2 billion for the year. This is the 10th consecutive year of double-digit growth for Nucala.

    請看下一張投影片。呼吸系統免疫和發炎領域全年銷售額成長 18%,主要得益於 Benlysta 和 Nucala 的強勁表​​現。今年,在需求成長和所有主要指南的支持下,貝利尤單抗(Benlysta)的銷量成長了22%。由於其具有預防器官損傷的獨特優勢,且擁有超過14年的安全性和臨床應用經驗,目前美國82%的生物製劑初治患者都選擇使用貝利尤單抗。Nucala 成長了 15%,全年營收達到 20 億英鎊。這是Nucala連續第十年實現兩位數成長。

  • Moving to Oncology, sales were up 43%. In the year, Jemperli sales were up 89%, reflecting our differentiated profile in endometrial cancer. Ojjaara grew 60%, driven by growth in all markets following the new data at EHA, emphasizing the importance of early intervention. Based on these data, NCCN included Ojjaara as Category 1 for patients with anemia. We expect this to drive uptick in first line, although growth will be slower than what we have seen with second line.

    轉戰腫瘤領域,銷售額成長了 43%。今年,Jemperli 的銷售額成長了 89%,反映了我們在子宮內膜癌領域的差異化優勢。Ojjaara 成長了 60%,這得益於 EHA 公佈的新數據所推動的所有市場的成長,凸顯了早期介入的重要性。根據這些數據,NCCN 將 Ojjaara 列為貧血患者的 1 級藥物。我們預計這將推動第一線藥物銷售成長,儘管成長速度會比二線藥物銷售成長速度慢。

  • Zejula sales decreased, reflecting FDA labeling restrictions, and we remain focused on the potential we have for Blenrep, now approved in 15 markets globally. Deborah will cover HIV shortly. Given the continued strong performance and momentum across the specialty portfolio, we are expecting sales to grow low double-digit for 2026.

    Zejula 的銷售額下降,反映了 FDA 的標籤限制,我們仍然專注於 Blenrep 的潛力,該產品目前已在全球 15 個市場獲得批准。黛博拉稍後將介紹愛滋病相關內容。鑑於特種產品組合持續強勁的表現和發展勢頭,我們預計 2026 年銷售額將實現兩位數低成長。

  • Next slide, please. The strong performance of Nucala in 2025 was driven by our successful launch in COPD. This launch also had a halo effect on all of Nucala's indications, resulting in higher market share in asthma and nasal polyps, also fueling brand growth in 2026. We are applying the lessons from the severe asthma market with Nucala to the launch of Xtentia, which is now approved in the US, UK, and Japan.

    請看下一張投影片。Nucala 在 2025 年的強勁表現得益於我們在 COPD 領域的成功上市。此次上市也對 Nucala 的所有適應症產生了光環效應,從而提高了其在氣喘和鼻息肉領域的市場份額,並推動了該品牌在 2026 年的成長。我們將從Nucala在重度氣喘市場中汲取的經驗教訓應用到Xtentia的上市中,該產品目前已在美國、英國和日本獲得批准。

  • We know that there is a significant opportunity in the bio-naive population, as only 27% of US-eligible patients are on a biologic. Market research shows that 97% of patients would prefer or likely switch to a biologic with six-monthly dosing. Xtentia has demonstrated a 72% reduction in exacerbations leading to hospitalizations in an indication where we know lack of therapy adherence leads to worse clinical outcomes.

    我們知道,在未接受過生物製劑治療的人群中存在著巨大的機會,因為只有 27% 的美國符合條件的患者正在接受生物製劑治療。市場調查顯示,97% 的患者會偏好或可能改用每六個月給藥一次的生物製劑。Xtentia 已證明可使病情加重導致住院的幾率降低 72%,而我們知道,在缺乏治療依從性會導致更差的臨床結果的情況下,這種適應症的治療依從性會降低。

  • The second key launch this year is for Blenrep, our off-the-shelf BCMA agent for multiple myeloma, available in the community setting where 70% of patients are treated. We've made fast progress on our launch in the UK and are applying lessons learned in the US, particularly around eye care networks.

    今年第二個重點上市產品是 Blenrep,這是我們用於治療多發性骨髓瘤的現成 BCMA 藥物,可在社區環境中使用,70% 的患者都在社區接受治療。我們在英國的業務拓展取得了快速進展,並將從美國學到的經驗教訓應用到業務拓展中,尤其是在眼科護理網絡方面。

  • We've now engaged around 18,000 eye care professionals in the US, enabling smooth collaboration between treating physicians and eye care professionals, and have had positive feedback on the simplification of our ramps. We continue to expect this to be a slow ramp-up as we support prescribers and patients to ensure a positive first experience and robust adoption.

    我們目前已與美國約 18,000 名眼科護理專業人員合作,實現了治療醫生和眼科護理專業人員之間的順暢合作,並收到了對我們坡道簡化的積極反饋。我們預計這將是一個緩慢的推廣過程,我們將為處方醫生和患者提供支持,以確保良好的首次體驗和穩健的推廣應用。

  • I will now hand over to Deborah to cover HIV.

    接下來我將把主題交給黛博拉,由她來介紹愛滋病相關內容。

  • Deborah Waterhouse - Chief Executive Officer, ViiV Healthcare and President - GSK Global Health

    Deborah Waterhouse - Chief Executive Officer, ViiV Healthcare and President - GSK Global Health

  • Thank you, Nina. We enter 2026 confident in our unique position to lead the next transformation in HIV care. Sales growth was 11% in the year, powered by accelerated patient demand for our long-acting injectables and our foundational oral two-drug regimen, Dovato.

    謝謝你,妮娜。進入 2026 年,我們充滿信心,相信我們擁有獨特的優勢,能夠引領愛滋病治療領域的下一個變革。受患者對我們長效注射劑和基礎口服雙藥療法 Dovato 的加速需求推動,本年度銷售額成長了 11%。

  • Demand continued to increase across all regions, most notably in the US, which grew 14% in 2025, continuing to outpace competition in market share gain. We're the only commercially established long-acting HIV treatment regimen, backed by over four years of real-world data. We're delivering long-acting innovation at scale and are delighted with our ongoing portfolio transition to long-acting regimens. In 2025, over 75% of our growth came from long-acting injectables, which now represent around a third of US sales.

    所有地區的需求持續成長,其中美國的需求成長最為顯著,2025 年成長了 14%,在市場佔有率成長方面持續超越競爭對手。我們是唯一獲得商業認可的長效 HIV 治療方案,並有超過四年的真實世界數據支持。我們正在大規模地提供長效創新產品,並且對我們持續向長效療法過渡的產品組合感到非常滿意。到 2025 年,我們 75% 以上的成長來自長效注射劑,目前長效注射劑約占美國銷售額的三分之一。

  • With treatment accounting for 90% of the total $22 billion HIV market, we are pleased that Cabenuva grew 42% in 2025, fueled by patient demand and accelerated switches from competitor products, reaching more than 75% in the US this quarter. In long-acting prevention, Apretude grew 62% in 2025, withstanding any impact from a competitor launch.

    治療業務佔 220 億美元 HIV 市場總額的 90%,我們很高興地看到,在患者需求和加速從競爭對手產品轉向 Cabenuva 的推動下,Cabenuva 在 2025 年增長了 42%,本季在美國的轉換率已超過 75%。在長效預防領域,Apretude 預計到 2025 年將成長 62%,能夠抵禦競爭對手產品上市帶來的任何影響。

  • In 2026, we expect continued growth momentum, and so today, we are guiding mid- to high single-digit growth. This quarter, we also announced Pfizer will exit ViiV, and Shionogi's shareholding will increase, simplifying the shareholder structure. GSK will maintain the same position. We look forward to continuing our highly successful collaboration to advance our pipeline and portfolio of long-acting HIV medicines.

    我們預計 2026 年將繼續保持成長勢頭,因此今天我們給出的預期是中高個位數成長。本季度,我們也宣布輝瑞將退出 ViiV,鹽野義的持股比例將增加,簡化股東結構。葛蘭素史克將維持原有立場。我們期待繼續保持卓有成效的合作,推動我們的長效 HIV 藥物研發管線和產品組合。

  • Moving on to our INSTI-led long-acting pipeline, powered by unmatched patient insight, we are set to deliver transformative launches over the next decade, enabling us to navigate the Dolutegravir loss of exclusivity and accelerate long-term growth. We believe twice-yearly treatment presents our most significant commercial opportunity and, through a combination of novel assets, presents the potential to change the HIV treatment paradigm once again. At CROI, we will share data that will help inform our regimen selection for twice-yearly HIV treatment.

    接下來,我們將著眼於以 INSTI 為主導的長效藥物研發管線,憑藉無與倫比的患者洞察力,我們將在未來十年推出具有變革意義的產品,從而應對多替拉韋失去獨家銷售權的影響,並加速長期增長。我們相信,一年兩次的治療方案為我們帶來了最重要的商業機會,並且透過結合創新資產,有可能再次改變 HIV 治療模式。在 CROI 大會上,我們將分享有助於我們選擇每年兩次 HIV 治療方案的數據。

  • Starting with VH184, a potential first-in-class, third-generation INSTI with IP protection through to at least 2040. We'll present key data on its unique resistance profile versus a competitor and findings from an ongoing first time-in-human trial, exploring its significant potential for up to twice-yearly dosing. We strongly believe this asset has the power to redefine the long-acting landscape, and we remain extremely confident in its potential to become the backbone of our long-acting treatment regimens.

    從 VH184 開始,這是一款潛在的首創的第三代 INSTI,其智慧財產權保護至少持續到 2040 年。我們將展示其與競爭對手相比獨特的抗藥性特徵的關鍵數據,以及正在進行的首次人體試驗的結果,探索其每年最多兩次給藥的巨大潛力。我們堅信這項資產有能力重新定義長效藥物的格局,並且我們對其成為我們長效治療方案支柱的潛力仍然充滿信心。

  • To pair with our INSTI once selected, we are evaluating two partners, VH499 and our bNAb, N6LS. Data at CROI for VH499 will show potential dosing durations. For N6LS, one of the broadest and most potent bNAbs in development, we'll share more data focused on Q4M dosing, with Q6M dosing data expected this year. This year, we'll also begin Quattro, our Phase 3 registrational study for four-monthly HIV treatment.

    一旦選定我們的 INSTI,我們將評估兩個合作夥伴:VH499 和我們的 bNAb N6LS。CROI 上的 VH499 數據將顯示潛在的給藥持續時間。對於 N6LS(目前正在研究的最廣泛、最有效的 bNAb 之一),我們將分享更多以每 4 個月給藥一次為重點的數據,預計今年將公佈每 6 個月給藥一次的數據。今年,我們也將啟動 Quattro,這是我們針對每四個月一次的 HIV 治療的 3 期註冊研究。

  • This critical step builds on our Q2M success, and we are on track to file in 2027 and launch in 2028. At launch, we still expect to have the only long-acting treatment options on the market for years to come. Our strategy is clear, and our execution is strong. We are fully confident and well-positioned to drive sustained long-term performance, and we'll continue to update you on our Q6M regimen selection.

    這個關鍵步驟建立在我們第二季度的成功之上,我們預計在 2027 年提交申請,並在 2028 年推出產品。上市之初,我們預計在未來幾年內,我們的產品仍將是市場上唯一提供長效治療方案的產品。我們的策略清晰明確,執行力強勁。我們完全有信心並已做好充分準備,推動長期持續的業績成長,我們將繼續向您報告我們每 6 個月一次的治療方案選擇。

  • We look forward to introducing you to our new head of R&D, Charlotte Allerton, who will succeed Kim Smith upon her retirement at the end of Q1.

    我們期待向您介紹我們新的研發主管夏洛特·阿勒頓,她將在第一季末金·史密斯退休後接任該職位。

  • I'll now hand back to Nina.

    現在我把麥克風交還給妮娜。

  • Nina Mojas - President, Global Product Strategy

    Nina Mojas - President, Global Product Strategy

  • Thanks, Deborah. Turning to vaccines, sales were GBP9.2 billion in the year, up 2%, driven by European and international region sales of Shingrix and Bexsero. Shingrix sales were GBP3.6 billion, up 8%, driven by Europe and international region, offset by the US. In Europe, sales were supported by our focus on comorbid patients.

    謝謝你,黛博拉。疫苗方面,該年度銷售額為 92 億英鎊,成長 2%,主要得益於 Shingrix 和 Bexsero 在歐洲和國際地區的銷售。欣格瑞的銷售額為 36 億英鎊,成長 8%,主要得益於歐洲和國際地區的成長,但卻被美國的銷售額所抵銷。在歐洲,我們專注於合併症患者,這促進了銷售成長。

  • And in international region, Japan continued to grow following expanded public funding. And in China, we saw similar sales to 2024. In 2026, we expect market performance outside of the US and China to benefit Shingrix sales, offset by slowing US immunization rates and our partner in China managing inventory.

    在國際領域,隨著公共資金的增加,日本經濟持續成長。在中國,我們看到了與 2024 年類似的銷售情況。2026 年,我們預計美國和中國以外的市場表現將有利於 Shingrix 的銷售,但美國免疫接種率放緩以及我們在中國的合作夥伴管理庫存將抵消這一影響。

  • In meningitis, sales were up 12%, with strong continuous growth across Europe and international, driven primarily by Bexsero, up 16% for the year. Bexsero demand increased in Europe, partly due to MenB outbreaks.

    腦膜炎藥物銷售額成長了 12%,在歐洲和國際市場持續強勁成長,主要得益於 Bexsero 的推動,該產品全年成長了 16%。由於B群腦膜炎雙球菌疫情爆發,歐洲對Bexsero的需求增加。

  • Ex-US represents 69% of Bexsero's global full-year sales, demonstrating continued growth from national immunization programs and geographic expansion. In the US, we retain MenB market leadership with 74% market share and have seen positive signs for Pentavalent with initial stock building.

    美國以外的市場佔 Bexsero 全球全年銷售額的 69%,顯示國家免疫計畫和地理擴張帶來了持續成長。在美國,我們保持著 MenB 市場的領先地位,市場佔有率為 74%,隨著初期庫存的積累,五價疫苗也出現了積極的跡象。

  • Turning to Arexvy, sales were up 2% for the year, also driven by ex-US growth. We continue to monitor the evolving pediatric vaccine landscape in the US. At this time, insurance coverage remains as before, and we expect the recent HHS changes to be manageable, given GSK's broad portfolio of vaccines. For 2026, we expect sales growth to be in the range of low single-digit decline to stable.

    再來看 Arexvy,其全年銷售額成長了 2%,這也得益於美國以外地區的成長。我們將繼續關注美國兒科疫苗領域的最新動態。目前,保險覆蓋範圍與之前相同,鑑於葛蘭素史克擁有廣泛的疫苗產品組合,我們預計美國衛生與公眾服務部最近的變化是可控的。我們預計 2026 年的銷售成長將在個位數百分比下降到穩定之間。

  • Next slide, please. Turning to GenMed, sales were slightly down for the year. Strong growth of Trelegy was offset by other respiratory and established products. Globally, Trelegy continues to be the top-selling brand for asthma and COPD, and in the US, the ICS class is growing, with Trelegy leading in share driven by GOLD guidelines and strong execution. In anti-infectives, we are taking a targeted approach to align access to Blujepa in uncomplicated UTIs with positive initial insights. For complicated UTIs, we now have a PDUFA date of 18th of June for tebipenem in the US

    請看下一張投影片。再來看 GenMed,該公司今年的銷售額略有下降。Trelegy的強勁成長被其他呼吸系統產品和成熟產品所抵消。在全球範圍內,Trelegy 仍然是氣喘和 COPD 最暢銷的品牌,在美國,吸入性糖皮質激素 (ICS) 類藥物正在增長,Trelegy 在 GOLD 指南和強有力的執行推動下,市場份額領先。在抗感染藥物方面,我們採取有針對性的方法,使非複雜性泌尿道感染患者能夠獲得 Blujepa,這與積極的初步見解相一致。對於複雜性泌尿道感染,替比培南在美國的PDUFA日期現已確定為6月18日。

  • Looking forward, we expect sales growth to be in the range of low single-digit decline to stable, reflecting pricing pressures and generic competition of our established portfolio. In the US, across the broader portfolio, we navigated the impact of the Medicare redesign from the Inflation Reduction Act near the upper end of our $400 million to $500 million range.

    展望未來,我們預期銷售成長將處於個位數低幅下降至穩定狀態,這反映了價格壓力以及我們現有產品組合面臨的仿製藥競爭。在美國,在更廣泛的投資組合中,我們應對了《通貨膨脹削減法案》對醫療保險改革的影響,其影響接近我們 4 億至 5 億美元範圍的上限。

  • I will now hand over to Tony to talk to you about our progress in R&D.

    現在我將把發言權交給托尼,讓他向大家介紹我們在研發方面取得的進展。

  • Tony Wood - Chief Scientific Officer, Head - R&D

    Tony Wood - Chief Scientific Officer, Head - R&D

  • Thank you, Nina. Next slide, please. Starting with the pipeline, there's greater focus and opportunity here than ever before. Our top priority is to accelerate development to deliver new products to patients faster.

    謝謝你,妮娜。請看下一張投影片。從管道建設開始,這裡比以往任何時候都更有關注和機會。我們的首要任務是加快研發速度,以便更快地將新產品帶給病患。

  • In 2025, we secured five FDA regulatory approvals and started seven new pivotal trials: three for Extensa in COPD, two for efimostirmen in MASH, one for velsatinib in second-line GIST, and Risres, our B7-H3 ADC, in extensive stage small cell lung cancer. I'm delighted with the progress we're making to deliver the pipeline, shorten development timelines, and access world-leading innovation through BD.

    2025 年,我們獲得了 5 項 FDA 監管批准,並啟動了 7 項新的關鍵性試驗:3 項針對 Extensa 治療 COPD,2 項針對 efimostirmen 治療 MASH,1 項針對 velsatinib 治療二線 GIST,以及 Risres(我們的 B7-H3 ADC)治療廣泛期肺癌小細胞。我對我們在推進產品線、縮短開發週期以及透過 BD 獲取世界領先的創新方面所取得的進展感到非常滿意。

  • Next slide, please. In respiratory, we've extended our leadership through a focus on exacerbation prevention with long-acting treatments and now have approval for Extensa, the world's first and only six-monthly biologic to treat patients with severe eosinophilic asthma. Also, in respiratory, COPD is a growing area of significant unmet need.

    請看下一張投影片。在呼吸系統領域,我們透過專注於使用長效療法來預防病情加重,進一步鞏固了我們的領先地位,現在我們獲得了 Extensa 的批准,這是世界上第一個也是唯一一個每六個月使用一次的生物製劑,用於治療重度嗜酸性粒細胞性哮喘患者。此外,在呼吸系統疾病領域,慢性阻塞性肺病(COPD)是一個日益嚴重的未滿足醫療需求領域。

  • A patient hospitalized with an exacerbation has less than a 50% chance of survival over a five-year period, alongside a cost to US healthcare of around $7 billion per year. Our work to understand the role that inflammation plays in chronic airway disease has led to an emerging and differentiated pipeline of long-acting options for COPD patients.

    因病情加重而住院的患者,五年內的生存幾率不到 50%,同時每年對美國醫療保健系統造成約 70 億美元的損失。我們為了解發炎在慢性氣道疾病中所扮演的角色所做的工作,已經為 COPD 患者開發出一系列新興的、差異化的長效治療方案。

  • Starting with Extensa, the Phase 3 ENDURA trials recruit patients at moderate risk of exacerbations, while VIGILANT is the first-ever study of an antibody for patients at an early stage of disease who are at risk of rapid progression. Our Phase 2 trial, investigating the ultra-long-acting T cell monoclonal antibody GSK 283 in asthma patients, is on track to generate data by the end of this year and will further guide development of a six-monthly option for patients with a low T2 phenotype. The portfolio also includes a PDE3/4 inhibitor with potential for DPI use in Phase 1 development in China, complementing our leadership position with Trelegy.

    從 Extensa 開始,3 期 ENDURA 試驗招募有中度病情惡化風險的患者,而 VIGILANT 是首個針對處於疾病早期階段、有快速進展風險的患者的抗體研究。我們正在進行 2 期試驗,研究超長效 T 細胞單株抗體 GSK 283 在氣喘患者中的療效,預計今年年底前得出數據,並將進一步指導開發針對低 T2 表型患者的每六個月一次的治療方案。該產品組合還包括一種 PDE3/4 抑制劑,在中國的 1 期開發中具有用於乾粉吸入劑的潛力,這與 Trelegy 形成了互補,鞏固了我們的領先地位。

  • Looking now to refractory chronic cough. I'm pleased to confirm that we achieved last patient first visit for the CALM-2 study in December, and we're now on track to report Phase 3 data from the total program around mid-2026, in line with our prior guidance. We believe Camlipixant will provide an effective treatment in RCC, where there are no approved therapies in the US and approximately 10 million patients diagnosed globally who could benefit from this medicine.

    接下來我們來探討難治性慢性咳嗽。我很高興地確認,CALM-2 研究的最後一位患者已於 12 月完成首次訪視,目前我們正按計劃於 2026 年年中左右公佈整個項目的 3 期數據,這與我們之前的指導一致。我們相信 Camlipixant 將為 RCC 患者提供有效的治療方案,目前美國尚無核准的 RCC 療法,全球約有 1,000 萬名 RCC 患者可能受益於這種藥物。

  • Next slide, please. A focus on inflammatory pathways of disease and how this leads to fibrosis, particularly in the lung, liver, and kidney, underpins our development programs in fibroinflammatory mechanisms. We are pleased with the progress of efimostirmen, our potential best-in-class, once-monthly FGF21 analog, which started Phase 3 trials for MASH last year.

    請看下一張投影片。我們以疾病的發炎路徑及其如何導致纖維化(尤其是在肺、肝和腎臟)為重點,進行纖維發炎機制的研發計畫。我們對 efimostirmen 的進展感到滿意,這是一種潛在的同類最佳的每月一次的 FGF21 類似物,去年已開始針對 MASH 進行 3 期試驗。

  • As a reminder, in Phase 2, EFI demonstrated sustained improvement in fibrosis and resolution of MASH in patients with F2, F3 stage disease. These data supported the start of our ZENITH-1 and 2 pivotal studies. We plan to start the NEBULA Phase 3 studies, which will recruit a more advanced F4 patient population later this year. Also in our hepatology pipeline is GSK 990, an siRNA therapeutic targeting HSD17B13.

    提醒一下,在第 2 期試驗中,EFI 證實了 F2、F3 期疾病患者的纖維化持續改善和 MASH 消退。這些數據支持了我們進行 ZENITH-1 和 2 項關鍵研究。我們計劃於今年稍後啟動 NEBULA 第三階段研究,該研究將招募更晚期的 F4 患者群體。此外,我們的肝病產品線還有 GSK 990,這是一種針對 HSD17B13 的 siRNA 療法。

  • Consistent with human genetics of this target, preliminary data from the Phase 2 STARLIGHT study in alcoholic liver disease demonstrates favorable trends in reduced liver enzymes, despite ongoing alcohol consumption, and this with no emerging safety concerns. These assets have the potential to reverse cirrhosis, where 20% to 50% of patients with associated complications die within one year.

    與該標靶的人類遺傳學一致,酒精性肝病 2 期 STARLIGHT 研究的初步數據顯示,儘管持續飲酒,肝酵素水平仍呈現下降的良好趨勢,且未出現任何安全問題。這些資產有可能逆轉肝硬化,而患有肝硬化並伴隨併發症的患者中,有 20% 至 50% 會在一年內死亡。

  • Next slide, please. Last month, we were pleased to announce positive results from the BEWELL One and BEWELL Two studies, our Phase 3 trials of bepirovirsen for the treatment of patients with chronic hepatitis B, a disease which affects more than 250 million people worldwide, causing over 1 million deaths each year. We believe that BEPI has the potential to transform chronic hepatitis B treatment and become the first-ever fixed course of therapy with functional cure at a significantly higher rate than today's standard of care.

    請看下一張投影片。上個月,我們很高興地宣布了 BEWELL One 和 BEWELL Two 研究的積極結果,這是我們針對慢性乙型肝炎患者進行的 bepirovirsen 3 期試驗,慢性乙型肝炎是一種影響全球超過 2.5 億人的疾病,每年造成超過 100 萬人死亡。我們相信,BEPI 有潛力改變慢性B型肝炎的治療方式,並成為首個功能性治癒率顯著高於目前標準療法的固定療程。

  • This is important because chronic hepatitis B accounts for around 56% of liver cancer cases, and real-world evidence shows that functional cure reduces this risk by around 90%. We look forward to sharing these data with regulators during the first half of the year and at an upcoming scientific congress.

    這很重要,因為慢性B型肝炎約佔肝癌病例的 56%,而現實世界的證據表明,功能性治癒可將這種風險降低約 90%。我們期待在今年上半年以及即將舉行的科學大會上與監管機構分享這些數據。

  • Next slide, please. Our oncology pipeline is a critical part of the portfolio. Starting with Blenrep, we anticipate mature OS data from DREAMM-7 in early 2028 to support second-line registration in the US. In the first-line transplant-ineligible setting, DREAMM-10 is recruiting well, and we recently expanded the number of US sites to increase US patient participation.

    請看下一張投影片。我們的腫瘤產品線是產品組合的關鍵組成部分。從 Blenrep 開始,我們預計 DREAMM-7 將於 2028 年初獲得成熟的 OS 數據,以支援其在美國的二線註冊。對於不適合第一線移植的患者,DREAMM-10 招募工作進展順利,我們最近擴大了美國研究中心的數量,以提高美國患者的參與度。

  • DREAMM-10 uses a lower dose when compared to second-line studies and evaluates dual endpoints of MRD and PFS. Interim MRD and safety data are expected in early 2028. Also, in the first-line setting, we'll start a study looking at Blenrep quad regimen in a younger, fitter population later this year.

    DREAMM-10 與二線研究相比採用較低的劑量,並評估 MRD 和 PFS 的雙重終點。中期MRD和安全性數據預計將於2028年初公佈。此外,在一線治療方面,我們將在今年稍後開始一項研究,考察 Blenrep 四聯療法在更年輕、更健康人群中的應用。

  • Moving now to Ojjaara. We continue to generate data to support decision-making for myelofibrosis patients with anemia, and a Phase 2 study in myelodysplastic syndrome is currently recruiting. We also continue to develop lifecycle indications for Jemperli. Later this year, we anticipate results from a pivotal AZUR-1 trial for Jemperli in dMMR locally advanced rectal cancer. AZUR-1 was designed following the publication of transformative data, which showed 100% complete clinical response rate in a single-center monotherapy study.

    現在前往奧賈拉。我們持續產生數據,以支持對患有貧血的骨髓纖維化患者的決策,目前正在招募骨髓增生異常綜合症患者進行第 2 期研究。我們也持續發展 Jemperli 的生命週期適應症。今年晚些時候,我們預計將公佈 Jemperli 治療 dMMR 局部晚期直腸癌的關鍵性 AZUR-1 試驗結果。AZUR-1 的設計源自於一項變革性數據的發表,該數據顯示,在單中心單藥治療研究中,臨床完全緩解率達到 100%。

  • We're excited about Jemperli's potential for patients with this disease. Velsatinib, our KIT inhibitor, which targets all clinically relevant enzyme mutations, has started Phase 3 in second-line GIST, with first-line to start later this year. Velsatinib has the potential to replace current standard of care and is designed to offer a well-tolerated schedule with greater efficacy against resistant mutations.

    我們對Jemperli在治療這種疾病方面的潛力感到興奮。我們的 KIT 抑制劑 Velsatinib 可針對所有臨床相關的酵素突變,目前已開始在二線 GIST 治療中進行 3 期臨床試驗,第一線治療將於今年稍後開始。Velsatinib 有潛力取代目前的標準療法,其設計旨在提供耐受性良好的治療方案,並對抗藥性突變具有更高的療效。

  • Moving now to our other ADCs. Our B7-H3 targeting molecule, which I will now call Risres, recently received its fifth regulatory designation with orphan drug status in SCLC. With this transformative potential in mind, we've initiated a global program encompassing multiple solid tumor trials for Risres, called EMBOLD.

    接下來看看我們的其他ADC。我們針對 B7-H3 的標靶分子(我將其命名為 Risres)最近獲得了第五個監管認定,並被授予小細胞肺癌孤兒藥資格。考慮到這種變革性的潛力,我們啟動了一項全球計劃,其中包括針對 Risres 的多項實體瘤試驗,該計劃名為 EMBOLD。

  • The first of these studies, EMBOLD SCLC 301, has started ex-US recruitment in second and third line. US recruitment will start later this year and include tarlatamab-exposed patients. We have extensive plans for additional Risres Phase 3 starts in the next 12 to 18 months. In the first half of this year, we also plan to start recruitment for pivotal Phase 3 trials for MoRes, our B7-H4 ADC in platinum-resistant ovarian cancer and in patients with recurrent endometrial cancer.

    其中第一項研究 EMBOLD SCLC 301 已開始在美國以外地區招募二線和三線病患。美國招募工作將於今年稍後開始,並將包括接受過tarlatamab治療的患者。我們已製定了在未來 12 至 18 個月內啟動更多 Risres 第三期計畫的宏偉計劃。今年上半年,我們也計劃開始招募 MoRes(我們的 B7-H4 ADC)的關鍵性 3 期試驗患者,該藥物用於治療鉑金抗藥性卵巢癌和復發性子宮內膜癌患者。

  • We're targeting a conference this year to present interim data from our early Phase BEHOLD-1 study for patients with ovarian and endometrial cancers, and we anticipate further pivotal study starts for this molecule during 2026.

    我們計劃今年召開一次會議,公佈針對卵巢癌和子宮內膜癌患者的早期 BEHOLD-1 研究的中期數據,並預計在 2026 年啟動該分子的進一步關鍵性研究。

  • Next slide, please. Business development is a core part of how we're accelerating our pipeline and accessing innovation. Two weeks ago, we announced an agreement to acquire RAPT Therapeutics, whose lead asset is Ozuriquimab, a potential best-in-class, long-acting, anti-IgE monoclonal for food allergy, which is currently in Phase 2. Food allergy is a chronic inflammatory condition with severe reactions leading to anaphylaxis, emergency care, and persistent lifestyle disruption.

    請看下一張投影片。業務拓展是我們加速產品線開發和獲得創新成果的核心組成部分。兩週前,我們宣布達成收購 RAPT Therapeutics 的協議,該公司的主要資產是 Ozuriquimab,這是一種潛在的同類最佳、長效抗 IgE 單株抗體,用於治療食物過敏,目前處於 2 期臨床試驗階段。食物過敏是一種慢性發炎性疾病,嚴重反應會導致過敏性休克、需要緊急治療,並持續擾亂生活方式。

  • In the US, severe food allergies impact over 17 million patients, with an estimated $33 billion cost of economic burden, underscoring the need for more effective treatment options. We expect the deal to close this quarter and look forward to progressing this important asset into Phase 3 development.

    在美國,嚴重的食物過敏影響超過 1,700 萬名患者,估計造成 330 億美元的經濟負擔,凸顯了更有效的治療方案的必要性。我們預計該交易將於本季完成,並期待推進這一重要資產進入第三階段開發。

  • Next slide, please. In conclusion, 2025 saw further strong momentum in the pipeline, which continues into 2026. We have critical data readouts to come for BEPI, Camlipixant, Jemperli, Q4M PrEP, and Extensa for EGPA. We also have 10 pivotal starts planned for this year, including more than five from our ADCs, two for advanced MASH, and QUATRO, our Q4M treatment Phase 3 trial for HIV, all of which are supporting our growth in specialty medicines. I'm excited about our progress and our prospects.

    請看下一張投影片。總之,2025 年專案儲備持續保持強勁勢頭,這一勢頭將延續到 2026 年。我們即將公佈 BEPI、Camlipixant、Jemperli、Q4M PrEP 和 Extensa(用於治療 EGPA)的關鍵數據讀數。我們今年還計劃啟動 10 個關鍵項目,其中包括 5 個以上的 ADC 項目、2 個針對晚期 MASH 的項目,以及針對 HIV 的 Q4M 治療 3 期試驗 QUATRO,所有這些都將支持我們在專科藥物領域的成長。我對我們的進展和前景感到興奮。

  • I'll now hand over to Julie.

    現在我將把麥克風交給茱莉。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Thank you, Tony, and good afternoon, everyone. Next slide, please. Starting with the income statement for the full year, with growth rate stated at CER. As highlighted, sales grew 7%, while core operating profit grew 11%. This leverage was primarily driven by a 3% increase in SG&A, as investment in product launches was balanced with productivity improvements. Additionally, royalty income benefited from the RSV IP settlement, the new mRNA royalty streams, and Kesimpta performance.

    謝謝你,東尼,大家下午好。請看下一張投影片。首先是全年損益表,成長率以固定匯率計算。如前所述,銷售額成長了 7%,核心營業利潤成長了 11%。這種槓桿作用主要源自於銷售、一般及行政費用成長 3%,因為產品發布投資與生產力提升達到了平衡。此外,版稅收入還受益於 RSV IP 和解協議、新的 mRNA 版稅流以及 Kesimpta 的表現。

  • R&D growth of 11% reflects our acceleration of investment across multiple key specialty assets. Core EPS grew 12%, supported by the share buyback and lower interest expense due to strong operating cash flows. Finally, turning to total results, growth primarily reflects the impact of the Zantac charge taken in 2024.

    研發投入成長 11%,反映了我們在多個關鍵專業領域加大投資。核心每股盈餘成長 12%,這得益於股票回購和強勁的營運現金流帶來的利息支出減少。最後,從整體業績來看,成長主要反映了 2024 年 Zantac 費用的影響。

  • Next slide, please. The operating margin increased 110 basis points in 2025, bringing total accretion at CER to 470 basis points over the last four years. This increase was primarily driven by SG&A margin improvement of 90 basis points, while gross margin continued to benefit from the portfolio transition towards specialty, growing 40 basis points.

    請看下一張投影片。2025 年營業利潤率提高了 110 個基點,使過去四年以固定匯率計算的總增幅達到 470 個基點。這一成長主要得益於銷售、一般及行政費用率提高了 90 個基點,而毛利率則繼續受益於產品組合向專業化轉型,增長了 40 個基點。

  • R&D expenditure increased as we reinvested the additional royalty income into our pipeline to support the initiation of the Phase 3 Efimostirmen trials and prepared pivotal trials for the ADCs in multiple indications. Incorporated within this margin improvement were core charges of GBP300 million taken in Q4, split evenly across supply chain and SG&A to drive productivity benefits. Currency was a headwind to margin, lowering the reported margin to 29.9% for the year.

    我們將額外的特許權使用費收入再投資於我們的產品線,以支持啟動 Efimostirmen 的 3 期試驗,並為多種適應症的 ADC 準備關鍵性試驗,因此研發支出增加。這項利潤率提升包含了第四季度提列的 3 億英鎊核心費用,平均分配至供應鏈和銷售、一般及行政費用,旨在提高生產力。匯率波動對利潤率造成了不利影響,導致全年報告的利潤率降至 29.9%。

  • Next slide, please. Turning to the cash flow. Cash generated from operations was GBP8.9 billion, or more than GBP10 billion, excluding Zantac payments, up GBP1.6 billion year-on-year, driven by higher operating profit, favorable RAR movements, and the CureVac settlement, partially offset by increased trade receivables. Free cash flow increased to GBP4 billion, or more than GBP5 billion, excluding Zantac, driven by strong CGFO. Zantac payments in 2025 were GBP1.2 billion, and the settlement process is now materially complete, with GBP1.9 billion paid in total, drawing a line under this matter.

    請看下一張投影片。接下來看一下現金流狀況。經營活動產生的現金流為 89 億英鎊,若不計入 Zantac 付款,則超過 100 億英鎊,同比增長 16 億英鎊,主要得益於營業利潤增長、RAR 的有利變動以及 CureVac 和解協議,但部分被貿易應收款增加所抵消。自由現金流增至 40 億英鎊,若不計入 Zantac,則超過 50 億英鎊,這主要得益於強勁的資本充足率成長。2025 年 Zantac 的賠償金額為 12 億英鎊,和解程序現已基本完成,總共支付了 19 億英鎊,此事就此結束。

  • Next slide, please. Turning to capital allocation. Underlying free cash generation was strong at over GBP8 billion before investment decisions. GBP4.5 billion was deployed in CapEx and BD, as we added three potentially best-in-class clinical stage specialty assets to the pipeline and completed multiple early-stage and platform deals.

    請看下一張投影片。接下來討論資本配置。在做出投資決策之前,公司基本自由現金流強勁,超過 80 億英鎊。我們在資本支出和業務拓展方面投入了 45 億英鎊,為產品線增加了三個潛在的一流臨床階段專業資產,並完成了多項早期和平台交易。

  • Shareholder distributions totaled GBP4 billion through the dividend and the share buyback, with 93 million shares repurchased at an average price of 1,473, and the remaining GBP0.6 billion will be completed in half one. Overall, our balance sheet remains strong, with net debt to EBITDA relatively stable year-on-year at 1.3 times, including the absorption of Zantac and the buyback.

    透過分紅和股票回購,股東分紅總額達到 40 億英鎊,其中以平均每股 1,473 英鎊的價格回購了 9,300 萬股,剩餘的 6 億英鎊將在上半年完成。整體而言,我們的資產負債表依然強勁,淨負債與 EBITDA 的比率年比相對穩定在 1.3 倍,其中包括對 Zantac 的吸收和回購。

  • Next slide, please. Now, turning to the guidance for 2026, with growth rates stated at CER. Starting with our headline guidance, we expect sales growth of 3%-5%, core operating profit and core EPS to both grow at 7%-9% and to pay a dividend of GBP0.70, a 6% increase. Product area growth is once again led by specialty at a low double-digit percentage growth, including mid to high single-digit growth for HIV. Vaccines and Gen Med are both expected to be a low single-digit decline to stable, and we expect sales growth to be evenly phased through the year.

    請看下一張投影片。現在,讓我們來看看 2026 年的指導意見,成長率以固定匯率計算。首先,根據我們的主要業績指引,我們預計銷售額將增長 3%-5%,核心營業利潤和核心每股收益均增長 7%-9%,並​​派發每股 0.70 英鎊的股息,增長 6%。產品領域成長再次由專業領域引領,實現了兩位數的低成長率,其中 HIV 產品實現了個位數中高成長率。疫苗和通用醫療預計都將出現個位數低幅下滑或保持穩定,我們預計銷售成長將在全年平穩推進。

  • Turning to the P&L, gross margin is expected to continue to benefit from supply chain efficiencies and the portfolio transition towards specialty. SG&A will grow at a low single-digit percentage, benefiting from the acceleration of productivity initiatives. And R&D will continue to grow ahead of sales as we invest to advance the pipeline. Interest charges and the tax rate are expected to increase year-on-year. However, these will be offset by the benefits of the share buyback to EPS.

    從損益表來看,毛利率預計將繼續受益於供應鏈效率的提高和產品組合向專業化方向的轉型。銷售、一般及行政費用將以較低的個位數百分比成長,受益於生產力提升計畫的加速推進。隨著我們加大投入推動產品線,研發投入將持續領先銷售投入。預計利息支出和稅率將逐年上升。然而,這些不利影響將被股票回購對每股盈餘的益處所抵消。

  • Importantly, the phasing of operating profit growth will be heavily weighted towards the second half, reflecting the GBP300 million pound of charges taken in Q4 2025 and impacted by the annualization of the RSV settlement in the second quarter. Additionally, currency could be a headwind. If rates hold at the closing rates on the 28th of January, we would expect an impact of minus 3% on sales and minus 6% on operating profit.

    重要的是,營業利潤成長的階段性變化將主要集中在下半年,這反映了 2025 年第四季提列的 3 億英鎊費用,以及第二季 RSV 和解協議的年化影響。此外,匯率也可能構成不利因素。如果利率維持在 1 月 28 日的收盤價,我們預期銷售額將下降 3%,營業利潤將下降 6%。

  • Next slide, please. Before I finish, I wanted to take a moment to share the continued performance of the business. In 2021, we provided outlooks on four financial KPIs for the five-year period to 2026. We have delivered consistent revenue growth and improvements in operational efficiency. We are on track to deliver against all the four KPIs. Taking the midpoint of our 2026 guidance ranges would lead to delivery of 8% sales and 13% operating profit CAGR over this period.

    請看下一張投影片。在結束之前,我想花一點時間分享一下公司目前的業績表現。2021年,我們對2026年的五年期間的四個財務KPI進行了展望。我們實現了持續的收入成長和營運效率的提升。我們有望實現所有四個關鍵績效指標。以我們 2026 年指導範圍的中點計算,在此期間,銷售額將達到 8% 的複合年增長率,營業利潤將達到 13% 的複合年增長率。

  • Additionally, cash generation has been significantly enhanced, and we're on track to reach more than GBP10 billion in 2026. This, together with shareholder returns and a strengthened balance sheet, lay strong foundations for the next phase of growth. Our usual IR roadmap is shown in the appendix, signaling the major value inflections in 2026 and 2027.

    此外,現金流也大幅提升,我們預計在 2026 年實現超過 100 億英鎊的目標。這一點,加上股東回報和更穩健的資產負債表,為下一階段的成長奠定了堅實的基礎。我們在附錄中展示了我們通常的投資者關係路線圖,其中指出了 2026 年和 2027 年的主要價值轉折點。

  • Thank you. And with that, I am pleased to hand back to Luke.

    謝謝。接下來,我很高興地把鏡頭交還給盧克。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Thanks, Julie. Looking forward, I see two clear things we need to do to create value for shareholders. The first one is top line. This means delivering on our ambition for 2031 and addressing the loss of dolutegravir exclusivity. The second is the pipeline. We need to accelerate what we have and add to it via smart BD, and we also need our labs to produce more competitive products. So to do these two things, we need to evolve as a company.

    謝謝你,朱莉。展望未來,我認為我們需要做兩件明確的事情來為股東創造價值。第一點是頂線。這意味著要實現我們 2031 年的目標,並解決多替拉韋獨佔權喪失的問題。第二點是管道。我們需要加速現有成果的轉化,並透過智慧業務拓展來豐富成果,同時我們也需要實驗室生產出更具競爭力的產品。所以,為了實現這兩件事,我們需要公司本身發展。

  • Products are the key in this business, and we need to be more product-centric. And to accelerate the pipeline, we need to have more scientific courage and be more agile to capitalize on opportunities when we see them. Each quarter, you'll hear more detail about how we're going to make this happen.

    在這個產業,產品是關鍵,我們需要更加以產品為中心。為了加速研發進程,我們需要更有科學勇氣,並且更有彈性地抓住機會。每個季度,您都會聽到更多關於我們如何實現這一目標的細節。

  • Next slide, please. To conclude, 2025 was a strong year for GSK. For 2026, we're guiding for another year of top-line growth and operating leverage, and for the long term, we know what we need to do to create value for shareholders and patients, and the focus is now on evolving the company to do it.

    請看下一張投影片。總之,2025年對葛蘭素史克來說是業績強勁的一年。展望 2026 年,我們預期營收和營運槓桿將持續成長;展望未來,我們知道需要做什麼才能為股東和病患創造價值,現在的重點是推動公司發展以實現這一目標。

  • Thank you, and we'll now move to Q&A.

    謝謝,接下來我們將進入問答環節。

  • Operator

    Operator

  • James Gordon, Barclays.

    詹姆斯·戈登,巴克萊銀行。

  • James Gordon - Equity Analyst

    James Gordon - Equity Analyst

  • James Gordon from Barclays. First one, respiratory. Can you elaborate on R&D commercial strategy in COPD and asthma? Because you've now got Nucala, Extensa, and then IL-33 and TSLP all in development, but some overlapping products, and I don't want to double count. And so how do we think about segmenting this, given you've got products going for the same disease and then also quite a lot of these mechanisms also have multiple competitors also looking at them for the same diseases?

    巴克萊銀行的詹姆斯‧戈登。第一個是呼吸系統疾病。您能否詳細介紹慢性阻塞性肺病和氣喘的研發商業化策略?因為現在有 Nucala、Extensa,還有 IL-33 和 TSLP 都在研發中,但有些產品有重疊,所以我不想重複計算。那麼,鑑於有多種產品針對同一種疾病,而且許多同類產品也有多個競爭對手針對同一種疾病,我們該如何考慮進行市場區隔呢?

  • The second question was HIV, and I heard the comments on long-acting, strong uptake and exciting next-generation data at CROI. But so when could we see the six-monthly treatment, and PrEP Phase 3 trials start now? And, commercially, what is the implications of the four-month and six-monthly in terms of your TAM?

    第二個問題是關於 HIV 的,我在 CROI 會議上聽到了關於長效、強效吸收和令人興奮的下一代數據的評論。那麼,我們什麼時候才能看到每六個月一次的治療方案以及 PrEP 第三階段試驗開始呢?從商業角度來看,四個月和六個月的週期對您的TAM(目標市場)有何影響?

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Great. Thanks, James, and I appreciate the question. So Tony, should we go into COPD and then I might add a little bit of color at the end of that in terms of how we're positioned the assets and what our thinking is. It's obviously was dynamic. And then, Deborah, do you want to cover HIV.

    偉大的。謝謝你,詹姆斯,我很感謝你的提問。所以托尼,我們是不是應該談談慢性阻塞性肺病(COPD)?然後我可能會在最後補充一些關於我們如何配置資產以及我們的想法的細節。它顯然是動態的。那麼,黛博拉,你想報道愛滋病嗎?

  • I think we're in a very healthy shape there, some more color there. And then Julie, just want to cover the assumptions around the GBP40 billion. Again, I will just take this opportunity just in case we get any other questions to reiterate the commitment to the GBP40 billion. And again, I think we have a clear pathway to that. So Tony, over to you.

    我認為我們那邊的情況非常好,也增添了一些色彩。然後,朱莉,我想說明一下關於 400 億英鎊的假設。我再次藉此機會重申,如果還有其他問題,我們將承諾提供 400 億英鎊的資金。而且,我認為我們已經有了實現這一目標的明確途徑。東尼,現在輪到你了。

  • Tony Wood - Chief Scientific Officer, Head - R&D

    Tony Wood - Chief Scientific Officer, Head - R&D

  • Yeah, let me, let me start. Thanks for the question, James. First of all, I'm really pleased with the progress we're making in respiratory. Obviously, just to mark last year, the Nucala approval in COPD in the middle of the year, and then at the end of the year, Extensa in severe eosinophilic asthma as the first ultra long-acting entry in our pipeline.

    好的,讓我先開始。謝謝你的提問,詹姆斯。首先,我對我們在呼吸系統領域的進展感到非常滿意。顯然,為了紀念去年,Nucala 在年中獲批用於治療 COPD,然後在年底,Extensa 作為我們研發管線中首個超長效藥物獲批用於治療重度嗜酸性粒細胞性氣喘。

  • I think what's important to understand about COPD, James, obviously, huge opportunity there, 300 million individuals globally and significant cost to the US healthcare system, as I outlined in the presentation. But it's a complex disease, it's a heterogeneous disease, and that's why we're placing ourselves across a range of different long-acting mechanisms. The way you can think about it is there is the high EO population. This is where IL-5 and Extensa and Nucala are positioned.

    詹姆斯,我認為了解 COPD 的關鍵在於,顯然,這是一個巨大的機遇,全球有 3 億人患有此病,並且給美國醫療保健系統帶來了巨大的成本,正如我在演講中概述的那樣。但這是一種複雜的疾病,一種異質性疾病,這就是為什麼我們要採取一系列不同的長效治療機制。你可以這樣理解:這裡存在大量的 EO 人口。這就是IL-5、Extensa和Nucala的定位。

  • And again, let me just emphasize there that we have a label which covers both the bronchiectasis and the emphysemic and mixed populations. Important when one considers the reality of a hospital admission for a COPD patient. You can then think about the intermediate T2 population, which is the 150-300.

    再次強調,我們有一個標籤,涵蓋了支氣管擴張、肺氣腫和混合人群。考慮到慢性阻塞性肺病患者住院治療的實際情況,這一點非常重要。然後你可以考慮中間 T2 人群,即 150-300 人。

  • We were delighted to see the Nucala label there, but that's where we see, for example, our long-acting TSLP starting to play increasingly in the future, and then the low T2 population, and that's where we're positioning IL-33. So what we have, of course, is already starting in that high T2 population, the ENDURA 1 and 2 studies. That's the GOLD E population that we're looking at.

    我們很高興看到 Nucala 的標籤出現在那裡,例如,我們認為我們的長效 TSLP 將在未來發揮越來越重要的作用,然後是低 T2 人群,而 IL-33 正是針對這一人群的。當然,我們已經在 T2 高發生率中開始了 ENDURA 1 和 2 研究。這就是我們所關注的黃金E人群。

  • And the VIGILANT study, which, as I mentioned in the script, looks as a brand-new approach, looking at rapid progressers in that high eosinophil population. We also have ongoing Phase 1 and Phase 2 studies for the long-acting TSLPs and IL-33 mechanisms in the context of the stratification that I described.

    還有 VIGILANT 研究,正如我在劇本中提到的,它採用了一種全新的方法,著眼於嗜酸性粒細胞數量高的快速進展者。我們也針對我所描述的分層背景下的長效 TSLP 和 IL-33 機制,進行了第 1 期和第 2 期研究。

  • And then just to finish off, we'll be expecting in, in, in both of those to be starting pivotal studies over the next two to three years, once we have been informed by ongoing Phase 1 and Phase 2 work and competitor insights. And then lastly, just to finish off, important to emphasize, we also have the HRS-9821 molecule, which is the first nominated candidate from our Hengrui collaboration.

    最後,我們預計在未來兩到三年內,在獲得正在進行的 1 期和 2 期研究以及競爭對手的見解之後,這兩個項目將開始關鍵性研究。最後,作為總結,需要強調的是,我們還有 HRS-9821 分子,這是我們與恆瑞合作的第一個候選分子。

  • That's focused on dyspnea, which is associated pain associated with breathing, and fits nicely into our respiratory portfolio, given that that molecule has an opportunity to be a DPI-administered agent. Then lastly, in the lung group, we have the recent deal we did with Empirico, Empirico 012, and that's now called GSK821. That's a long-acting oligo, which is aimed at a broad spectrum, as I indicated. We haven't disclosed the mechanism yet, but we will in future as we gather more data.

    該藥物主要針對呼吸困難,即與呼吸相關的疼痛,並且由於該分子有機會成為乾粉吸入劑,因此非常適合我們的呼吸系統產品組合。最後,在肺癌領域,我們最近與 Empirico 達成了一項交易,即 Empirico 012,現在它被稱為 GSK821。正如我之前提到的,這是一種長效寡核苷酸,其作用範圍很廣。我們尚未公開該機制,但隨著我們收集到更多數據,將來會予以公佈。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Yeah. And James, what I will say is we're going to resist the temptation as a company to construct a lovely PowerPoint slide that shows how we'll carefully capture this bit and have trade-offs amongst our products. I mean, there is strategic intent here, but we also recognize there's a Darwinian dimension here, in terms of the data that these targets generate, but also the competition gets a vote as well. I mean, ultimately, the long acting is the future.

    是的。詹姆斯,我要說的是,作為一家公司,我們將抵制住誘惑,不會製作精美的 PowerPoint 幻燈片來展示我們將如何精心捕捉這一部分,並在我們的產品之間做出權衡。我的意思是,這裡面有戰略意圖,但我們也認識到這裡面有達爾文主義的維度,就這些目標產生的數據而言,而且競爭也起到了作用。我的意思是,歸根結底,長篇表演才是未來。

  • The launch for Nucala COPD in the US is going very well, and was just there on Monday. We have around well, depending on which dataset, 43%-46% of new patient starts already. The market research and the messaging is really resonating, but we have transferred all of our Nucala reps to Extensa, and Nucala COPD is being promoted by the Trelegy legacy team. Because, again, we need to place our bets on the future, and the ultimate future with IL-5 and higher EOS is gonna be long-acting Extensa for COPD.

    Nucala COPD 在美國的上市進展非常順利,就在週一。根據不同的數據集,我們大約有 43%-46% 的新患者已經開始接受治療。市場研究和宣傳訊息確實引起了共鳴,但我們已經將所有 Nucala 代表轉移到了 Extensa,而 Nucala COPD 則由 Trelegy 原始團隊負責推廣。因為,我們又一次需要把賭注押在未來,而IL-5和更高的EOS的最終未來將是長效Extensa用於治療COPD。

  • So thanks, James, I appreciate that question. Deborah, do you want to give an update?

    謝謝你,詹姆斯,我很感謝你的提問。黛博拉,你想報告最新情況嗎?

  • Deborah Waterhouse - Chief Executive Officer, ViiV Healthcare and President - GSK Global Health

    Deborah Waterhouse - Chief Executive Officer, ViiV Healthcare and President - GSK Global Health

  • Thanks, Luke. So, the key thing that I wanna re-emphasize is that we're on track to select our Q6M treatment regimen in the middle of the year. And as I said, we're gonna do a meet the management event mid-year, where I'll lay out a lot more detail about the pipeline. But let me just give you a top-line view now.

    謝謝你,盧克。所以,我想再次強調的關鍵一點是,我們正按計畫在年中選定我們的 Q6M 治療方案。正如我所說,我們將在年中舉辦一次管理層見面會,屆時我將詳細介紹人才儲備。但我現在只給你一個概括性的介紹。

  • So let's start with treatment. The treatment market is $20 billion in value, 90% of the value of the total HIV market. As I said in my presentation, Q6M is clearly our biggest opportunity in treatment. We're very confident in the assets that we've got to choose from, and the Croyde data that we'll present will show just how strong those assets are, particularly VH184, which is unique.

    那麼,我們就從治療開始吧。治療市場價值 200 億美元,佔 HIV 市場總價值的 90%。正如我在演講中所說,Q6M 顯然是我們治療領域最大的機會。我們對可供選擇的資產非常有信心,我們將展示的 Croyde 數據將表明這些資產有多強大,特別是 VH184,它是獨一無二的。

  • Third generation, really potent integrase inhibitor, and we believe that to have a really potent regimen, you need to have an integrase inhibitor at the core. So in terms of what kind of when studies will start, Q6M treatment, you'll see us move into Phase 2b this year. That puts us on track for our commitment, which is, the 28-30, launch for, our Q6M in treatment.

    第三代強效整合酶抑制劑,我們認為,要擁有真正有效的治療方案,就必須以整合酶抑制劑為核心。所以,就研究何時開始而言,Q6M 治療,你會看到我們今年進入 2b 期。這使我們朝著既定目標穩步前進,即在 28-30 日推出我們的 Q6M 治療方案。

  • In terms of PrEP, it's a, a different pathway because with the medicine that we're developing for Q6M PrEP, it's a pro-drug of cabotegravir, which we've talked about before, and that means that we'll be able to, go from Phase 1 to Phase 3 relatively rapidly.

    就 PrEP 而言,這是一條不同的途徑,因為我們正在開發的用於 Q6M PrEP 的藥物是卡博特韋的前藥,我們之前已經討論過,這意味著我們將能夠相對快速地從 1 期臨床試驗過渡到 3 期臨床試驗。

  • And the Phase 1 will be starting this year, where we'll then progress to dose selection, and then we'll do a bridging study from the data that we already have from Q2M. So our Q6M pathway is clear, and we're very confident in our ability to deliver against our milestones.

    第一階段將於今年開始,之後我們將進行劑量選擇,然後我們將根據我們從第二季度獲得的數據進行橋接研究。因此,我們的 Q6M 路徑很清晰,我們對實現里程碑目標的能力非常有信心。

  • But don't underestimate Q4M. There is a huge desire for Q4M in treatment and in PrEP, and we know that many clinicians are really looking forward to opening up their clinic capacity, which will double from what they've got today with Q2M, for Q4M. And I think what you're gonna see is a rapid cannibalization of 2 Q2M to Q4, and then actually you will see a rapid cannibalization from Q4 to Q6.

    但不要低估 Q4M。在治療和 PrEP 方面,人們對 Q4M 的需求非常大,我們知道許多臨床醫生非常期待開放他們的診所容量,這將比他們目前使用 Q2M 的容量翻一番,轉而使用 Q4M。我認為你會看到第二季到第四季之間出現快速的蠶食,然後實際上你會看到第四季到第六季之間出現快速的蠶食。

  • As I've said before, particularly in treatment, you see the market really open up as we progress through longer and longer durations between administrations. So the addressable market for Q2M is about 15% of patients. When we get to Q4, we get to 30% of patients, and then you've got, with Q6M in treatment, 50% of patients who would be very willing to take a long-acting injectable. That is a big chunk of the market, which is why we are so excited about the offering that Q6M in treatment and in PrEP, but particularly in treatment, will offer.

    正如我之前所說,尤其是在治療方面,隨著兩次治療之間的間隔時間越來越長,你會看到市場真正開放。因此,Q2M 的目標市場約佔患者的 15%。到了第四季度,就有 30% 的患者願意接受長效注射劑,而到了第六個月,接受治療的患者中將有 50% 非常願意接受長效注射劑。這佔據了很大的市場份額,因此我們對 Q6M 在治療和 PrEP 方面(尤其是治療方面)將提供的產品感到非常興奮。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Thanks, Deborah. Julie, quick answer on the other GBP40 billion. I think everyone knows, but let's confirm it.

    謝謝你,黛博拉。Julie,另外400億英鎊的問題,請快速回答。我想大家都知道,但我們還是確認一下吧。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Yeah, sure. Thanks, James, for the question. So in terms of what we've included, of the recent deals, IDRx has included Efimostirmen, together with the earlier stage Hengrui license, PDE3/4. Rapt, obviously, has just been announced, so it's not included at all in the LRF. And clearly, we continue, as Luke mentioned, to support our BD, to build and continue to build the pipeline.

    當然可以。謝謝詹姆斯的提問。就我們最近達成的交易而言,IDRx 已經將 Efimostirmen 以及早期階段的 Hengrui 許可證 PDE3/4 納入其中。顯然,Rapt 剛剛發布,所以它根本沒有被納入 LRF 中。顯然,正如盧克所提到的那樣,我們將繼續支持我們的業務拓展,建造並繼續建造產品線。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Great. Thanks, Julie. Next question please.

    偉大的。謝謝你,朱莉。下一個問題。

  • Operator

    Operator

  • Simon Baker, Redburn.

    西蒙貝克,雷德本。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Two, if I may, please. Firstly, on Blenrep, in light of the early feedback that you've had, you talked about the response to the REMS program. Can you just update us on how we should be thinking about the launch trajectory for Blenrep?

    如果可以的話,請給我兩個。首先,關於 Blenrep,鑑於您收到的早期回饋,您談到了對 REMS 計劃的回應。您能否簡要介紹一下我們應該如何考慮 Blenrep 的發射軌跡?

  • And then secondly, a slightly bigger picture question for you, Luke. You did mention some of the facets of your strategy. I just wondered if you'd give us a bit more detail on how and in what form we're gonna learn more about that strategy over the course of the year. Is this something where there will be additional disclosure as we go through the quarterly calls, or are you envisaging having capital markets day or similar events to lay out the strategy in that sort of form?

    其次,盧克,我想問你一個更宏觀的問題。您確實提到了您策略中的一些方面。我只是想問一下,您能否更詳細地告訴我們,在這一年中,我們將如何以及以何種形式了解更多關於該策略的資訊。這會在我們進行季度電話會議時進行更多披露嗎?還是您計劃舉辦資本市場日或類似活動,以這種形式闡述該策略?

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Thanks, Simon. I'll come to Nina in a second. I mean, I think, as I said earlier, and thanks for your questions. Look, what you'll get from us is a very clear communication. If it's on track, you'll hear about it. If it's not, we'll call it out. And I really want to use these forums to regularly update on our progress and where we're going to. So I think these are a very effective forum to do it. And we'll see how that evolves over time.

    謝謝你,西蒙。我馬上就去找妮娜。我的意思是,就像我之前說的那樣,謝謝你的提問。你看,我們會與你進行非常清晰的溝通。如果一切進展順利,你會聽到相關消息的。如果不是,我們會指出來。我非常希望利用這些論壇定期更新我們的進展和未來的發展方向。所以我認為這些平台是實現這一目標的非常有效的途徑。我們將拭目以待,看看這種情況會如何發展。

  • Nina, I mean, again, as I said in my intro, I mean, Nina and I have worked together a long time. She has huge experience in oncology and is now responsible for the whole portfolio in partnership with Tony. And also, we've had a number of other members join the team that have been in their roles during this commercial transformation.

    妮娜,我的意思是,就像我在開場白裡說的那樣,我和妮娜已經一起工作了很長時間。她在腫瘤學領域擁有豐富的經驗,現在與托尼共同負責整個計畫組合。此外,還有許多其他成員加入了團隊,他們在這次商業轉型期間一直擔任各自的角色。

  • And there's a lot of, yeah, history with those individuals at Aventis and Roche and AstraZeneca. So they're people that many of you will know, and they've got a very strong record. And the aim of bringing them into the team again is just to rebalance and increase their focus on the portfolio, the pipeline, and product execution.

    是的,Aventis、Roche 和 AstraZeneca 的那些人之間有很多淵源。所以他們都是你們很多人都認識的人,而且他們有著非常優秀的成績。讓他們重新加入團隊的目的只是為了重新平衡工作重心,並讓他們更專注於產品組合、產品線和產品執行。

  • So, with that intro, Nina, over to you on Blenrep in terms of launch, uptake, and initial feedback.

    那麼,Nina,有了這些介紹,接下來就由你來談談 Blenrep 的發布、接受度和初步回饋。

  • Nina Mojas - President, Global Product Strategy

    Nina Mojas - President, Global Product Strategy

  • Yeah, great. Yeah, Simon, so, you remember Blenrep was launched in the US just at the end of November, so there are not many, we can't really share a significant update based on the sales numbers. But what we do know, we launched in the UK, middle of the year, and, the dynamic is, opening the accounts is, systematic.

    好的,太棒了。是的,西蒙,你還記得Blenrep是11月底才在美國推出的嗎?所以銷量不高,我們無法根據銷售數據分享任何重要的更新資訊。但我們知道的是,我們在英國於年中推出了這項服務,而且,開戶流程是系統化的。

  • It's happening, but it is definitely slower because of the coordination of care with eye care professionals. By now, we have about 70% of patients covered in the accounts that are open in the UK, and, based on the uptake there, we are actually extremely satisfied.

    這件事正在發生,但由於需要與眼科護理專業人員協調治療,所以進展肯定比較慢。目前,我們在英國開設的帳戶中,約有 70% 的患者獲得了保障,而且根據當地的接受度來看,我們非常滿意。

  • Two things, there is huge interest to try Blenrep, and then, we know that, that we have done good, good homework in, guiding physicians how to use the drug. Physicians are very much aware of the need of extended, dosing intervals to reduce or to reduce or, or to avoid, eye-related side effects.

    有兩件事,人們對嘗試 Blenrep 非常感興趣,而且我們知道,我們在指導醫生如何使用這種藥物方面已經做了很多非常充分的準備工作。醫生非常清楚需要延長給藥間隔,以減少或避免眼部副作用。

  • Now, translating that to the US, we expect similar dynamic. So the timing of opening the accounts, is going to take a bit of time, longer probably than what you would see with an asset that doesn't need that coordination of care. But what we, we did learn from the first launch, as an example, I think I mentioned we, are actively educating 18,000 eye care professionals.

    現在,如果把這種情況轉化到美國,我們也預期也會出現類似的動態。因此,開設帳戶的時間需要一些時間,可能比不需要這種協調管理的資產所需的時間還要長。但是,我們從第一次發布中學到的東西,例如,我想我提到過,我們正在積極培訓 18,000 名眼科護理專業人員。

  • As an illustration, comparing to the first launch of Blenrep, we had only about 5,000-6,000 eye care professionals engaged in our program, helping treaters to treat the patients. REMS has been a big factor. I think you know that. It has been received very positively.

    舉例來說,與 Blenrep 的首次推出相比,當時只有大約 5000-6000 名眼科護理專業人員參與我們的計劃,幫助治療人員治療患者。REMS(風險評估和緩解策略)是一個重要因素。我想你知道的。它獲得了非常正面的評價。

  • Currently, REMS is not an issue. Physicians are very much used to REMS programs, and Blenrep REMS is very similar. Eye care professionals scale, as we said, we are going to reach a significantly higher number and then communicating to the physicians how to use the drug. That extended dosing is very relevant to enable early positive experience, and I would say that's what we see so far.

    目前,風險評估和緩解策略(REMS)還不是問題。醫生們對 REMS 計劃非常熟悉,而 Blenrep REMS 與 REMS 非常相似。正如我們所說,眼科護理專業人員的規模將會擴大,我們將達到一個更高的數字,然後向醫生們傳達如何使用這種藥物。延長給藥時間對於獲得早期積極體驗非常重要,我認為到目前為止我們也看到了這一點。

  • To your question, what can we expect? What we said before, it is not going to be a quick ramp-up, it's going to be a slow ramp-up, but the positive initial experience is more relevant than starting a high number of patients very early and then having a negative experience.

    對於你的問題,我們可以期待什麼?正如我們之前所說,這不會是一個快速增長的過程,而是一個緩慢增長的過程,但積極的初期經驗比過早地讓大量患者接受治療然後出現負面經驗更重要。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Thanks, Nina. I would just add one other, one other interesting data point: if we look at usage right now for Blenrep, it's about 50/50 between academic and community, which, you know, our strategy is to focus on the community. With a product that is being relaunched and not a lot of experience in the community, I think this is an encouraging trajectory, because at this point, you'd expect volume to be dominated by the academic centers who tend to move on newer things earlier.

    謝謝你,妮娜。我只想補充一點,另一個有趣的數據點:如果我們看一下 Blenrep 目前的使用情況,學術界和社群的使用率大約是 50/50,而我們的策略是專注於社群。對於一款重新推出的產品,以及在社群中缺乏經驗的產品而言,我認為這是一個令人鼓舞的發展軌跡,因為在目前這個階段,你會預期銷量會主要由那些傾向於更早採用新事物的學術中心主導。

  • But we can see, to Nina's point, this strategy of focusing on the community, building confidence, supporting them to dose the first five patients, appears to be showing promise, and we will give you a lot more granularity at the Q1 update, including on depemokimab.

    但正如 Nina 所說,這種以社區為中心、建立信心、支持他們給前五名患者用藥的策略似乎很有前景,我們將在第一季更新中提供更多細節,包括關於 depemokimab 的資訊。

  • Thanks, Simon. I appreciate the questions. Next, please.

    謝謝你,西蒙。感謝大家的提問。下一位。

  • Operator

    Operator

  • Michael Leuchten, Jeffries.

    Michael Leuchten,傑弗里斯。

  • Michael Leuchten - Analyst

    Michael Leuchten - Analyst

  • Two, please. One for Luke. It's been reported that there is a reduction in R&D staff, I think about 350 people in the US and also in the UK. Just wondering, is that part of a broader program, normal attrition? Just wonder if you could put it into context.

    請給我兩個。給盧克的一份。據報道,研發人員有所減少,我認為美國和英國大約減少了 350 人。我只是好奇,這是整個專案的一部分,還是正常的人員流失?想請您幫忙解釋一下它的背景。

  • And then back to Nina on Extensa. There're a few ways one could launch a product like this, especially early on, sort of go into experienced patients, where I guess it'd be easier to make an argument to get patients on drug more quickly or into a naive population to broaden out the market. Can you talk a lot about a little bit of the launch curve for 2026? So how should we think about this as the year progresses?

    然後又回到 Extensa 上的 Nina。推出這類產品有幾種方法,尤其是在早期階段,可以先瞄準有經驗的患者,這樣更容易說服他們更快地接受藥物治療;或者瞄準對藥物一無所知的群體,以擴大市場。能詳細談談2026年的發布曲線嗎?那麼隨著時間的推移,我們該如何看待這個問題呢?

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Thanks, Michael. So I'll cover the first one. I mean, look, we're going to manage the business, and where we see success, we'll reinforce it. If we have programs that are less promising or Tony and Nina, in managing the portfolio, decide to cull something, then we're going to be very dynamic and shift resources behind to where we can get the best return, generate assets that are most compelling, and ultimately, in doing this, we will have happy shareholders at the end of the process.

    謝謝你,麥可。那我就先講第一個問題。我的意思是,你看,我們會管理好這項業務,在看到成功的地方,我們會加強它。如果我們有一些前景不太好的項目,或者托尼和尼娜在管理投資組合時決定剔除某些項目,那麼我們將非常靈活地將資源轉移到能夠獲得最佳回報、創造最有吸引力資產的地方,最終,通過這樣做,我們將讓股東在流程結束時感到滿意。

  • So this is very much this element of accelerating R&D and simplifying how we work. And you'll see more of that. What we can assure you is that we will run the business with great discipline, and where we can see an opportunity, we will rapidly move resources, people, headcount, capital, to support that.

    所以,這很大程度上是為了加快研發速度,簡化我們的工作方式。你還會看到更多這樣的情況。我們可以向您保證的是,我們將以高度的紀律性來經營業務,一旦發現機會,我們將迅速調動資源、人員、員工人數和資金來支持機會。

  • Nina, AstraZeneca.

    妮娜,阿斯特捷利康。

  • Nina Mojas - President, Global Product Strategy

    Nina Mojas - President, Global Product Strategy

  • Yes, I can take that. Thank you, Michael. And just as a reminder, Michael, I think this information basically guides the strategy. We have about mid-twenties biopenetration in severe asthma, so about 25% of eligible patients now receive biologics, any. And of those who start on biologics, 65% will discontinue in the first 12 months. And that tells you if we would go for switch, active switch, that business wouldn't last very long because patients are dropping anyway. And I think we need to look at it in that context.

    是的,我可以接受。謝謝你,麥可。還有一點要提醒你,邁克爾,我認為這些訊息基本上指導著策略。目前,重度氣喘患者的生物滲透率約為 25%,因此約有 25% 的符合條件的患者現在接受生物製劑治療。而那些開始接受生物製劑治療的患者中,65% 會在前 12 個月內停止治療。這說明,如果我們選擇轉型,主動轉型,這項業務不會持續太久,因為病患數量無論如何都在下降。我認為我們需要在這種背景下看待這個問題。

  • Our main objective, I think Luke mentioned that, when we talk about our sales force, is going for bio-naive patients. It's very legitimate to expect there will be some switching, and there will be switching very likely from Nucala, hopefully also from other agents in severe asthma as well.

    我認為盧克提到過,當我們談到銷售團隊時,我們的主要目標是爭取那些從未接觸過生物製劑的患者。完全可以預期會出現一些藥物轉換,而且很可能會從 Nucala 轉換過來,希望也能從其他治療嚴重氣喘的藥物轉換過來。

  • What is more relevant is, can Extentia gain share from patients who would have otherwise started on other agents? And you know, six-monthly dosing, I think you have seen everything that we have seen from both physicians and patients, is that there is huge level of enthusiasm for long-acting six-monthly dosing, and that will hopefully translate into referential use of Extentia over other agents to initiate patients, but then also to start patients who otherwise wouldn't start on biologic yet.

    更重要的是,Extentia 能否從原本會選擇其他藥物的患者身上獲得市場份額?你知道,每六個月給藥一次,我想你已經從醫生和患者那裡看到了所有反饋,那就是大家對長效每六個月給藥一次的方案都抱有極大的熱情,希望這能轉化為 Extentia 相對於其他藥物的參考用途,用於啟動患者的治療,同時也能用於啟動那些原本不會開始使用生物製劑的患者。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Great. Thanks, Nina, and I think the positioning is the first and only biologic that delivers ultra-long protection in two doses a year. That's landing extremely well when we look at market research and perception.

    偉大的。謝謝妮娜,我認為這種定位是目前唯一一種每年只需注射兩次即可提供超長保護的生物製劑。從市場調查和市場反應來看,這個結果非常成功。

  • Thanks, Michael. Next question, please.

    謝謝你,麥可。下一個問題。

  • Operator

    Operator

  • Sachin Jain, Bank of America.

    Sachin Jain,美國銀行。

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • A couple of questions, please. Just, firstly to Nina, congrats on the new role. Perhaps a bit more detail on Blenrep. How many physicians have you had through the REMS certification process, and any cadence of how you think that will go through the year as a rate-limiting factor?

    請問幾個問題。首先,恭喜妮娜榮升新職。或許可以再詳細介紹一下 Blenrep。你們有多少醫生完成了 REMS 認證流程?您認為這項流程在今年會如何發展,並成為限制因素?

  • Second one for Deborah on the HIV event mid-year. Clearly, we're looking to Q6M start, but I wonder if you will be disclosing how you think about the financials of that business through the LOE.

    這是黛博拉在年中愛滋病活動上的第二篇報導。顯然,我們希望在第六季開始,但我想知道您是否會透過 LOE 揭露您對該業務財務狀況的看法。

  • And I guess two questions. One, how do you think about the rate of decline of this business relative to where consensus sits? And I guess Q6M isn't in the midterm guide, so do you plan on including it at that point if you start the Phase 3?

    我想問兩個問題。第一,您如何看待該業務的衰退速度與市場普遍看法之間的差距?我猜Q6M不在期中考指南裡,所以如果你開始第三階段考試,你打算到時候把它加進去嗎?

  • Then a quick one for you, Luke, just on your slide five and high-level objectives. You, you've mentioned two things. One, simplification. Do you intend to have any official cost savings program? And then secondly, R&D acceleration. Are there any specific programs that you can target for earlier readouts or filing?

    盧克,接下來給你一個簡短的問題,就你的第五張投影片和高層目標而言。你,你提到了兩件事。第一,簡化。你們是否打算推行任何正式的成本節約計畫?其次,是研發加速。是否有任何特定的項目可以針對性地提前發布數據或提交文件?

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Thanks, Sachin. So I'll answer the last question and then we'll go to Deborah and then finish with Nina. I mean we are always looking to save money because I think it's always an opportunity cost, right? So if we can move resources behind particular assets where we think there is a higher and return. And they have the clinical profile to justify it, then we will do that, and we will continue that in a dynamic and disciplined fashion.

    謝謝你,薩欽。那我先回答最後一個問題,然後我們輪到黛博拉,最後是妮娜。我的意思是,我們總是想辦法省錢,因為我認為這始終是一種機會成本,對吧?因此,如果我們能將資源轉移到我們認為回報更高的特定資產上,那就好了。如果他們具備證明其合理性的臨床特徵,那麼我們就會這樣做,並且我們會以積極、嚴謹的方式繼續這樣做。

  • Areas for acceleration. Again, I think naturally, the scale of B7-H3 is quite interesting, I think, (inaudible) -- it is a very competitive and dynamic area. But I think we're starting to see some color around the tox profile that could give us an edge. FGF21, we looked at all three of those companies. We think we've bought the best Again, you'd expect me to say that, but I think we can back it up in time with the profile of the frequency of the dosing and some of the profile of the product that will merge in time.

    加速發展領域。再次,我認為 B7-H3 的尺度非常有趣,(聽不清楚)——這是一個競爭非常激烈且充滿活力的領域。但我認為我們開始看到一些關於毒素特徵的訊息,這可能會給我們帶來優勢。FGF21,我們考察了這三家公司。我們認為我們買到了最好的。你可能會覺得我這麼說很正常,但我認為隨著時間的推移,我們可以透過給藥頻率和產品特性的組合來證明這一點。

  • So they're probably the key ones, TSLP as well, long-acting TSLP. Again, the target is being actively derisked by AstraZeneca. And I think that we have a plan to move that asset forwards and rapidly because it is a very attractive area. We think long-acting can really reframe to Nina's earlier point about how respiratory diseases are treated.

    所以它們可能是關鍵因素,TSLP 也是,長效 TSLP 也是。再次強調,阿斯特捷利康正在積極降低目標公司的風險。我認為我們已經制定了計劃,可以迅速推進該資產的開發,因為這是一個非常有吸引力的領域。我們認為長效藥物確實可以重新定義妮娜先前關於呼吸系統疾病治療方式的觀點。

  • Deborah, over to you on HIV.

    黛博拉,接下來請你談談愛滋病問題。

  • Deborah Waterhouse - Chief Executive Officer, ViiV Healthcare and President - GSK Global Health

    Deborah Waterhouse - Chief Executive Officer, ViiV Healthcare and President - GSK Global Health

  • Thank you, Sachin, for the question. So if we think about Q6M first, so we are intending to set out our HIV story in the middle of the year. At that point, once we've done a regimen selection and we then commence with Phase 2, we will put that into our long-range forecast, which is how we always operate when products get to that Phase two, that Phase 2 phase. You'll see that happen mid-year. You then asked about the evolution of the kind of the portfolio over time.

    謝謝你的提問,薩欽。所以如果我們先考慮 Q6M,那麼我們打算在年中公佈我們的 HIV 故事。屆時,一旦我們選定了治療方案並開始第二階段,我們將把方案納入我們的長期預測中,這就是產品進入第二階段時我們一貫的做法。年中你就會看到這種情況發生。然後您詢問了投資組合類型隨時間推移的演變。

  • Let me just give you a top-line view, and we will come back and talk more about this when we set out the HIV evolution in the middle of the year. So we've seen a relatively rapid decline of Triumeq, as the guidelines have moved away from Triumeq. And what's happened is, over the last 12 months, it's created dynamism in the market, and Dovato has benefited significantly, as has Cabenuva.

    我先給大家做一個概括性的介紹,等到年中我們討論愛滋病毒發展演變的時候,我們會再詳細討論這個問題。因此,我們看到 Triumeq 的使用率相對迅速下降,因為指南已經不再推薦 Triumeq。在過去 12 個月裡,這種情況為市場帶來了活力,Dovato 和 Cabenuva 都從中受益匪淺。

  • So the amount that's sitting in Triumeq and Tivicay, as you can see, is going down quite significantly in advance of the loss of exclusivity of dolutegravir, which is, to remind you, a glide path, not a cliff, starting in April 2028 in the US and then July 2029 in Europe with obviously Dovato and Juluca in the US having intellectual property coverage now until end of 2029 for Dovato and July 2030 for Juluca.

    因此,正如您所看到的,Triumeq 和 Tivicay 中的金額正在大幅下降,這主要是因為 dolutegravir 的獨佔權即將到期。需要提醒您的是,這是一個漸進的過程,而不是斷崖式下跌,其獨佔權將於 2028 年 4 月在美國到期,然後在 2029 年 7 月在歐洲到期。顯然,Dovato 和 Juluca 在美國的智慧財產權保護期目前分別持續到 2029 年底和 2030 年 7 月。

  • So the glide path's coming down. We're already seeing a move away from the old dolutegravir regimens into our newer regimens, and that is going to continue. And then what's going to happen is, we will continue to power forward with Cabenuva Q2M. It's doing incredibly well, growing fast. Apretude has not been dented by the launch of Sunlenca? So that will also continue to grow 2026 and beyond.

    所以下滑道正在下降。我們已經看到患者逐漸從舊的多替拉韋治療方案轉向我們更新的治療方案,而且這種趨勢還會持續下去。接下來,我們將繼續大力推進 Cabenuva Q2M 專案。它發展勢頭非常強勁,成長迅速。Sunlenca的推出並沒有對Apretude造成影響嗎?因此,到2026年及以後,這一趨勢將持續。

  • And then what we will see is Q4M, both treatment and PrEP, coming in and powering longer acting forward again until we reach the point at which we launch Q6M, and then we've got two brand-new molecules with intellectual property coverage, composition of matter patents through into the 2040s.

    然後我們將看到 Q4M(包括治療和 PrEP)上市,並再次推動長效藥物向前發展,直到我們推出 Q6M,屆時我們將擁有兩種全新的分子,其知識產權涵蓋物質組成專利,有效期至 2040 年代。

  • You see a dip in 2029 and 2030 for the franchise as we face into the largest erosion through the exclusivity loss, and then we come back out into growth in 2031 and beyond. That growth in that decade is going to be a significant contributor to GSK's success in the 2030s, because we are incredibly confident in the value to patients that the Q6M will bring.

    預計 2029 年和 2030 年該系列遊戲銷量將出現下滑,因為獨家授權的喪失將帶來最大的損失,然後從 2031 年及以後將恢復增長。未來十年的成長將成為葛蘭素史克在 2030 年代取得成功的重要因素,因為我們對 Q6M 將為患者帶來的價值充滿信心。

  • So if, you know, if that hopefully gives you a sort of a view as to how it's going to evolve. We will share more detail in the middle of the year, but I just want everybody to understand that HIV will be a big contributor to GSK's success this decade and into the future.

    所以,你知道,如果這能讓你對它將如何發展有一個大致的了解。我們將在年中分享更多細節,但我只想讓大家明白,愛滋病毒將是葛蘭素史克在本十年乃至未來取得成功的重要因素。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Right. Thanks, Deborah. Nina, quick answer and then we'll try to squeeze one more question --

    正確的。謝謝你,黛博拉。妮娜,先快速回答一下,然後我們再試著問最後一個問題。--

  • Nina Mojas - President, Global Product Strategy

    Nina Mojas - President, Global Product Strategy

  • Yes, definitely. Sachin, thank you, first of all, trying to avoid the situation where you will chase me next quarter for the same number, REMS hundreds -- hundreds. And obviously, that's just a start.

    是的,當然。薩欽,首先感謝你,我努力避免下個季度你又因為同樣的數字(REMS 數百——數百)追著我跑的情況。顯然,這只是個開始。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Yes. I mean we feel happy about where we're at. One more question and we have time for that.

    是的。我的意思是,我們對現狀感到滿意。最後一個問題,我們還有時間。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    史蒂夫·斯卡拉,TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Two questions. First, on Camlipixant. If GSK needs two positive trials to file, which is what the company has said previously, then what's the purpose of the pooled analysis? And/or has FDA confirmed it will accept filing based on pooled data, even if one trial is a negative?

    兩個問題。首先,關於Camlipixant。如果葛蘭素史克需要兩個陽性試驗才能提交申請(該公司之前曾表示過這一點),那麼匯總分析的目的是什麼?FDA是否已確認,即使其中一項試驗結果為陰性,也會接受基於匯總數據的申請?

  • And secondly, on Shingrix, what were sales to Zhifei in Q4, and what is your level of confidence in 2026 on this, on this drug?

    其次,關於Shingrix,第四季智飛的銷售額是多少?您對該藥物在2026年的銷售情況有多大信心?

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Sure. Tony, do you want to cover?

    當然。東尼,你想掩護嗎?

  • Tony Wood - Chief Scientific Officer, Head - R&D

    Tony Wood - Chief Scientific Officer, Head - R&D

  • Yeah, just quickly, hey, Steve, hi. Not going to get into details of regulatory strategy, but as you defined, what it's giving us is the option to take the approach both as independent and ultimately pooled studies. So it's worthwhile saying that we remain confident in the outcomes for both CAMEO-1 and CAMEO-2.

    是的,就簡單說一句,嘿,史蒂夫,你好。我不打算深入探討監管策略的細節,但正如您所定義的那樣,它賦予我們的選擇是既可以採取獨立研究,也可以最終採取匯總研究的方法。因此,值得一提的是,我們仍然對 CAMEO-1 和 CAMEO-2 的結果充滿信心。

  • Luke Miels - Chief Executive Officer - Designate, Director

    Luke Miels - Chief Executive Officer - Designate, Director

  • Yeah, and Steve, there was a shipment in December. We can get you that number offline. I don't have it off the top of my head. What I will say is that the underlying demand is improving in China, so it's up 6 times since the start of 2025.

    是的,史蒂夫,12 月有一批貨。我們可以私下幫你找到那個號碼。我一時想不起來。我想說的是,中國的潛在需求正在改善,自 2025 年初以來已經成長了 6 倍。

  • Now, it's a low base, and we've grown the market share versus Ganwei. So now we have 93% market share in that population, which is, you know, an operational improvement. And what is driving this? We've shifted the strategy to the one that we launched in Australia and also drove in Germany, and now we're employing in the US, which is also helping us get some traction there.

    現在,我們的市佔率很低,而且我們已經相對於贛威擴大了市場佔有率。所以現在我們在該族群中擁有 93% 的市場份額,這無疑是一項營運上的改善。而這背後的驅動力是什麼?我們已經將策略調整為在澳洲推出並在德國推廣的策略,現在我們正在美國實施該策略,這也有助於我們在美國取得一些進展。

  • Julie just told me it's GBP100 million we did at the end of last year. So there's still some stock in the pipe, but again, we'll give you more color on Q1, but it's heading in the right direction, along with Shingrix, in aggregate.

    朱莉剛剛告訴我,我們去年底的業績是1億英鎊。所以目前還有一些庫存,但我們會在Q1季度提供更多細節,但總的來說,它正朝著正確的方向發展,Shingrix也是如此。

  • So I think we'll stop there, because I know a lot of you need to join another call, and I want to respect that. Thank you again for investing the time to construct such thoughtful questions and joining the call and your interest in the company, and we look forward to updating you further next quarter. Thank you.

    所以我想我們就到此為止吧,因為我知道你們很多人還需要參加另一個電話會議,我想尊重這一點。再次感謝您抽出時間提出如此有見地的問題,並參與電話會議,感謝您對公司的關注,我們期待在下個季度向您提供更多最新資訊。謝謝。