葛蘭素史克 (GSK) 2025 Q1 法說會逐字稿

內容摘要

葛蘭素史克公司新任投資者關係主管康斯坦丁·費斯特 (Constantin Fest) 與艾瑪·沃姆斯利 (Emma Walmsley)、盧克·米爾斯 (Luke Miels) 和朱莉·布朗 (Julie Brown) 共同主持了 2025 年第一季業績電話會議。葛蘭素史克公佈財務業績強勁,集團銷售額成長 4%,主要得益於特種藥品業務。疫苗銷售量下降,但愛滋病治療藥物銷售強勁。該公司仍專注於研發生產力和未來成長機會。儘管存在不確定性,葛蘭素史克仍有信心實現 2025 年的預期。

電話會議重點介紹了即將推出的產品,包括 Nucala、depemokimab 和 Blenrep。葛蘭素史克對其產品線持樂觀態度,並已做好應對關稅等潛在挑戰的準備。本公司對疫苗研發持謹慎樂觀態度,致力於加大研發投入。由於供應鏈雙重採購和生產力舉措,葛蘭素史克對自己的地位充滿信心。

該公司正在對 camlipixant 進行研究,並繼續專注於業務發展機會。

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

  • Constantin Fest - Senior Vice President, Head-Investor Relations

    Constantin Fest - Senior Vice President, Head-Investor Relations

  • Ladies and gentlemen, a very warm welcome to the GSK Q1 2025 results call. My name is Constantin Fest, new Head of IR at GSK, and I'm delighted to be joined today by Emma Walmsley, Luke Miels, and Julie Brown. I am pleased to say Deborah Waterhouse, CEO of ViiV, returned this week full time; but David Redfern, Chairman of ViiV, will be covering HIV today. Tony Wood, our CSO, will also be joining us for Q&A.

    女士們、先生們,熱烈歡迎大家參加葛蘭素史克 2025 年第一季業績電話會議。我叫康斯坦丁·費斯特 (Constantin Fest),是葛蘭素史克公司新任投資者關係主管,今天我很高興能與艾瑪·沃姆斯利 (Emma Walmsley)、盧克·米爾斯 (Luke Miels) 和朱莉·布朗 (Julie Brown) 一起參加會議。我很高興地宣布,ViiV 執行長 Deborah Waterhouse 本周全職回歸;但 ViiV 董事長 David Redfern 今天將報導 HIV 相關問題。我們的首席策略長 Tony Wood 也將加入我們的問答環節。

  • Today's call will last approximately 1 hour, with the presentation taking around 30 minutes, and the remaining time for your questions. Please ask only one to two questions so that everyone has a chance to participate.

    今天的電話會議將持續約 1 小時,其中演示大約需要 30 分鐘,其餘時間用於回答您的問題。請只問一到兩個問題,以便每個人都有機會參與。

  • 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.

    在我們開始之前,請翻到投影片 3。這是通常的安全港聲明。除非另有說明,我們將使用固定匯率或 CER 來評論我們的業績。

  • I will now hand over to Emma on slide 4.

    我現在將投影片 4 交給 Emma。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Thank you, Constantin, and it's great to have you on board. Welcome to everybody joining us today. Please turn to the next slide.

    謝謝你,康斯坦丁,很高興你能加入我們。歡迎大家今天加入我們。請翻到下一張投影片。

  • GSK continues to make strong progress. Group sales were up 4% this quarter, our operating profit grew 5%, and core earnings per share also rose 5% to GBP0.449. This performance was in line with our expectations and again demonstrates the quality, strength, and resilience of GSK's portfolio.

    葛蘭素史克持續取得強勁進展。本季集團銷售額成長 4%,營業利潤成長 5%,每股核心收益也成長 5%,達到 0.449 英鎊。這項業績符合我們的預期,並再次證明了葛蘭素史克產品組合的品質、實力和彈性。

  • Sales growth was driven by Specialty Medicines, our largest business, up 17%, with strong contributions from Respiratory, Immunology and Inflammation, Oncology, and from HIV. As expected, Vaccine sales were down 6% and General Medicines sales were broadly stable. R&D delivery has continued, with two out of the five FDA product approvals we expect in 2025 now secured. And we completed the acquisition of IDRx which adds another very promising oncology asset to our pipeline.

    銷售額的成長主要得益於我們最大的業務——特種藥物,該業務增長了 17%,其中呼吸系統疾病、免疫學和發炎、腫瘤學以及愛滋病毒的貢獻尤為突出。正如預期的那樣,疫苗銷售額下降了 6%,而普通藥品銷售額基本上穩定。研發工作仍在繼續,我們預計 2025 年將有五種產品獲得 FDA 批准,目前已獲得兩種。我們完成了對 IDRx 的收購,這為我們的產品線增添了另一個非常有前景的腫瘤學資產。

  • Cash generated from operations was over GBP1 billion, providing further funds to invest in growth and to deliver returns to shareholders. Our dividend for the quarter increased to GBP0.16, and we've commenced the GBP2 billion share buyback program announced in February.

    經營活動產生的現金超過 10 億英鎊,為投資成長和為股東帶來回報提供了進一步的資金。我們本季的股息增加至 0.16 英鎊,我們已經啟動了 2 月宣布的 20 億英鎊股票回購計畫。

  • Alongside this, we are proud to have sustained progress with our trust goals and estimate that in the last four years, GSK has reached at least 2 billion people with our vaccines and medicines, including through our global health work.

    除此之外,我們很自豪能夠在信託目標方面持續取得進展,並估計在過去四年中,葛蘭素史克已透過我們的疫苗和藥品(包括透過我們的全球衛生工作)惠及至少 20 億人。

  • Finally, we're confirming the financial guidance previously given for 2025.

    最後,我們確認先前給予的 2025 年財務指引。

  • Next slide please. We continue to make good progress on delivering R&D productivity improvements and future growth opportunities. As we said at the full year, R&D is very focused on delivering the potential of 14 key pipeline opportunities, all of which are expected to launch between 2025 and 2031, and all of which have peak year sales potential of more than GBP2 billion. This portfolio demonstrates the strategic shift we've made to develop more specialty medicines, many of which offer long-acting preventative-type care and better adherence for patients. Along with the recent approvals for Penmenvy and Blujepa, we continue to expect FDA approvals for Nucala (COPD) imminently, Blenrep in July, and depemokimab by the end of the year.

    請看下一張投影片。我們在提高研發生產力和未來成長機會方面持續取得良好進展。正如我們在全年所說的那樣,研發非常注重發揮 14 個關鍵管道機會的潛力,這些機會預計都將在 2025 年至 2031 年之間推出,並且所有機會的年銷售峰值潛力都超過 20 億英鎊。該產品組合體現了我們為開發更多特種藥物而做出的策略轉變,其中許多藥物為患者提供長效預防性護理和更好的依從性。隨著 Penmenvy 和 Blujepa 最近獲得批准,我們預計 FDA 即將批准 Nucala(COPD)、7 月批准 Blenrep 以及年底批准 depemokimab。

  • Innovation in our pipeline also continues to be recognized. We received another breakthrough designation for our novel ADC targeting B7H3, and we look forward to sharing more data from our ADC programs later this year.

    我們的管道創新也持續得到認可。我們針對 B7H3 的新型 ADC 獲得了另一項突破性稱號,我們期待在今年稍後分享更多來自我們的 ADC 專案的數據。

  • This quarter, we also presented data from our high potential HIV injectable portfolio at CROI, including positive data from our third generation INSTI, which advances our leadership position in the development of long-acting agents to treat as well as prevent HIV infection.

    本季度,我們也在 CROI 上展示了我們具有高潛力的 HIV 注射劑產品組合的數據,其中包括來自第三代 INSTI 的積極數據,這提升了我們在開髮用於治療和預防 HIV 感染的長效藥物方面的領導地位。

  • Our number one priority for investment remains growth through innovation, organically in R&D and with continued targeted business development. And we're specifically prioritizing investment to key assets in RI&I and oncology, alongside long-acting HIV and core vaccine opportunities.

    我們投資的首要重點仍然是透過創新、有機研發和持續有針對性的業務發展實現成長。我們特別優先投資 RI&I 和腫瘤學領域的關鍵資產,以及長效 HIV 和核心疫苗機會。

  • On a broader investment front, we were also very pleased to break ground on our new state-of-the-art manufacturing facility in Marietta, Pennsylvania this quarter. This is squarely targeted on increasing manufacturing capacity for new pipeline products in the U.S. and means that GSK will have six manufacturing sites in America.

    在更廣泛的投資方面,我們也非常高興本季在賓州瑪麗埃塔破土動工建設新的最先進的製造工廠。此舉旨在提高美國新藥研發線產品的生產能力,這意味著葛蘭素史克將在美國擁有六個生產基地。

  • Next slide please. We remain highly confident in our commitments to growth. Whilst there are clearly elevated levels of uncertainty in the macro environment right now, including from possible sector tariffs, we start from a position of strength. Our momentum, together with the strength of our portfolio, the resilience we've built into our supply chain, and our proven capability to drive operating leverage mean we have the ability and options to navigate and mitigate this. This underscores our confidence that 2025 will be another year of profitable growth and why we remain on track to deliver our guidance and our outlooks.

    請看下一張投影片。我們對於成長的承諾仍然充滿信心。儘管目前宏觀環境的不確定性明顯增加,包括可能的行業關稅,但我們從一開始就處於強勢地位。我們的發展勢頭、強大的產品組合、我們在供應鏈中建立的韌性以及我們經過驗證的推動營運槓桿的能力意味著我們有能力和選擇來應對和緩解這一問題。這強調了我們對 2025 年將是另一個獲利成長年的信心,以及我們繼續按計劃實現指導和展望的原因。

  • With that, I'll hand over to Luke.

    說完這些,我就把麥克風交給盧克。

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Thanks, Emma. Please turn to the next slide. In Q1, we delivered GBP7.5 billion of sales, up 4% versus last year demonstrating the resilience of our diverse medicines and vaccines portfolio.

    謝謝,艾瑪。請翻到下一張投影片。第一季度,我們的銷售額達到 75 億英鎊,比去年增長 4%,展現了我們多樣化藥品和疫苗產品組合的韌性。

  • As Emma mentioned, growth in the quarter was driven by Specialty Medicines, which continued to more than offset anticipated headwinds in our Vaccines business. By region, growth was driven by Europe up 11%, with the U.S. up 4%, impacted by a challenging comparative base and the introduction of the IRA which, as previously stated, we anticipate to be a GBP400 million to GBP500 million headwind throughout the year.

    正如艾瑪所提到的,本季的成長是由特種藥物推動的,這繼續抵消了我們疫苗業務預期的阻力。按地區劃分,成長主要由歐洲推動,成長 11%,美國成長 4%,受到具有挑戰性的比較基數和 IRA 引入的影響,如前所述,我們預計 IRA 全年將帶來 4 億至 5 億英鎊的逆風。

  • Next slide please. Specialty Medicines continued its excellent momentum, growing 17% in Q1, with strong performances across all therapy areas. In addition, three of the five product approvals we expect this year are in Specialty Medicines. That's Blenrep, Nucala on COPD, and depemokinab, and I'll talk about them shortly.

    請看下一張投影片。特種藥物持續保持良好勢頭,第一季成長 17%,所有治療領域均表現強勁。此外,我們預計今年批准的五種產品中,有三種屬於特種藥物領域。那是 Blenrep、用於治療 COPD 的 Nucala 和 depemokinab,我很快就會談論它們。

  • RI&I was up 28% in the quarter. And within that, Benlysta, our treatment for lupus grew 39%; and Nucala, our anti-IL5 biologic treatment, grew 21%, with both of these benefiting from strong demand as well as the comparator, which saw U.S. channel inventory reductions in Q1 last year, a best of which will not repeat in the remainder of the year.

    本季 RI&I 成長了 28%。其中,我們用於治療狼瘡的藥物 Benlysta 增長了 39%;我們的抗 IL5 生物治療藥物 Nucala 增長了 21%,這兩種藥物都受益於強勁的需求,而比較藥物去年第一季美國渠道庫存減少,而這種情況在今年剩餘時間內不會再出現。

  • In Oncology, Q1 sales were up 53%, with sales of Jemperli and Ojjaara more than doubling. Jemperli, the only immuno-oncology-based treatment to show an overall survival benefit in endometrial cancer, continues to see increased patient uptake in the U.S. and Europe, following all-comers approval for primary and advanced or recurrent endometrial cancer. And Ojjaara sales were driven by high U.S. volumes and strong uptake following the new market launches in Europe and international. And this market expansion continued in Q1, with launches in Spain and Italy.

    在腫瘤學領域,第一季銷售額成長了 53%,其中 Jemperli 和 Ojjaara 的銷售額成長了一倍以上。Jemperli 是唯一一種在治療子宮內膜癌方面顯示出整體生存獲益的免疫腫瘤治療方法,在獲得用於治療原發性、晚期或複發性子宮內膜癌的全面批准後,該藥物在美國和歐洲的患者接受度持續增加。Ojjaara 的銷售得益於美國市場的高銷量以及在歐洲和國際新市場推出後的強勁增長。這一市場擴張在第一季繼續進行,並在西班牙和義大利推出。

  • We expect a very strong momentum in our Specialty Medicines portfolio to continue and reconfirm our 2025 sales guidance of low double-digit percent increase.

    我們預計,我們的特種藥品組合將持續保持強勁勢頭,並再次確認我們 2025 年銷售預期的低兩位數百分比成長。

  • Next slide please. Innovation is our priority and we've got three exciting approvals expected in Specialty Medicines this year. Blenrep was approved in the UK earlier this month and has an FDA PDUFA date in July, with a projected overall survival benefit of 33 months in DREAMM-7 compared to standard of care, manageable safety profile, and low treatment burden. Feedback from physicians is that Blenrep could redefine second line multiple myeloma treatments. Dose interruptions enable them to manage ocular side effects and it's an immediate 30-minute difffusion administered in a community setting, which is where 70% of patients are treated in the U.S.

    請看下一張投影片。創新是我們的首要任務,今年我們預計在特種藥物領域獲得三項令人興奮的批准。Blenrep 於本月初在英國獲得批准,FDA PDUFA 日期為 7 月,與標準治療相比,DREAMM-7 中的預期總體生存期為 33 個月,具有可控的安全性和較低的治療負擔。醫師的回饋是,Blenrep 可以重新定義多發性骨髓瘤的二線治療方法。劑量中斷使他們能夠控制眼部副作用,這是一種在社區環境中進行的 30 分鐘即時擴散治療,美國 70% 的患者都是在社區環境中接受治療的。

  • We're also being very thoughtful about the launch which, as I said in the past, will be staged. We'll work hand in hand with individual physicians and patients to ensure dose management is understood and the ophthalmic support network is in place. Laying this groundwork will help firmly establish Blenrep in the second line multiple myeloma market and demonstrate the benefits of this transformative medicine.

    我們也對這次發布會進行了深思熟慮,正如我過去所說的那樣,我們將分階段進行。我們將與個別醫生和患者攜手合作,確保了解劑量管理並建立眼科支持網絡。奠定這項基礎將有助於 Blenrep 在二線多發性骨髓瘤市場中站穩腳跟,並展示這種變革性藥物的益處。

  • Turning to Respiratory. GSK has been a leader in the prevention and treatment of respiratory disease for more than five decades. In 2015, we launched Nucala for severe asthma, the first monoclonal antibiotic to target IL-5. Next week, we're expecting FDA approval for a major new indication to Nucala to treat COPD, the third leading cause of death worldwide, affecting more than 300 million people globally. And we've got an experienced field force in place and are ready to launch. And we expect to share the full Phase 3 of the MATINEE trial results very soon, including data on the reduction of most serious exacerbations which lead to hospital presentations, which are known to be the strongest indicator of disease progression and death.

    轉向呼吸系統。五十多年來,葛蘭素史克一直是呼吸系統疾病預防和治療的領導者。2015 年,我們推出了用於治療嚴重氣喘的 Nucala,這是第一種針對 IL-5 的單株抗生素。下週,我們預計 FDA 將批准 Nucala 的一項重要新適應症,用於治療 COPD,COPD 是全球第三大死因,影響全球超過 3 億人。我們已擁有一支經驗豐富的現場隊伍,隨時準備好投入工作。我們期望很快分享 MATINEE 試驗第 3 階段的全部結果,包括減少導致住院的最嚴重病情惡化的數據,這些病情惡化被認為是病情進展和死亡的最強指標。

  • Also in Respiratory is depemokimab, our exciting new anti-IL5 medicine with a six-month dosing, which has been filed in all major markets for approval in both severe asthma and chronic rhinositis with nasal polyps, with the U.S. FDA decision expected towards the end of the year.

    同樣在呼吸系統領域,我們激動人心的新型抗 IL5 藥物 depemokimab 的給藥週期為六個月,已在所有主要市場提交申請,用於治療嚴重哮喘和伴有鼻息肉的慢性鼻炎,預計美國 FDA 將於今年年底做出決定。

  • In a pooled analysis of the swift pivotal studies in asthma with Type 2 inflammation, characterized by blood eosinophil count, depemokimab demonstrated a 72% reduction in exacerbations requiring hospitalization. And feedback from the asthma community on these data have been very positive. In a poll of pulmonologists, 86% think depemokimab could become a new standard of care; and 82% said they would consider prescribing depemokimab ahead of alternative biologics. So this is clearly a significant opportunity to increase the uptake in bio naive patients.

    在以血液嗜酸性粒細胞計數為特徵的 2 型發炎氣喘的快速關鍵研究的總結分析中,depemokimab 顯示需要住院治療的氣喘發作減少了 72%。哮喘社群對這些數據的回饋非常正面。在一項針對肺部疾病專家的調查中,86% 的人認為 depemokimab 可能成為新的治療標準; 82% 的人表示他們會考慮先開立 depemokimab,然後再開立替代生物製劑。因此,這顯然是增加生物初治患者接受度的重要機會。

  • Given rates in asthma remain low, we estimate that only around 21% of eligible asthma patients currently receive a biologic, with patients potentially benefiting from increased adherence from a twice-yearly dosing schedule. And we anticipate depemokimab will also capture share from shorter-acting alternatives. And this underpins our confidence in depemokimab's multi-billion-pound peak year sales potential.

    鑑於氣喘發病率仍然很低,我們估計目前只有約 21% 的符合條件的氣喘患者接受生物製劑治療,患者可能會受益於每年兩次的給藥計劃的依從性提高。我們預計 depemokimab 也將從短效替代品中搶佔市場份額。這增強了我們對 depemokimab 數十億英鎊峰值年銷售潛力的信心。

  • I'll now hand over to David to cover HIV.

    現在我將把愛滋病毒問題交給大衛。

  • David Redfern - President-Corporate Development

    David Redfern - President-Corporate Development

  • Thank you, Luke. We continue to deliver strong growth and momentum in HIV treatment and prevention, with sales growing 7%, driven by competitive execution and strong patient demand for our industry-leading innovative portfolio in Dovato, Cabenuva, and Apretude, all with gold standard integrase inhibitors at the core.

    謝謝你,盧克。我們繼續在愛滋病毒治療和預防領域保持強勁增長勢頭,銷售額增長 7%,這得益於競爭性執行力和患者對我們行業領先的創新產品組合(Dovato、Cabenuva 和 Apretude)的強勁需求,這些產品均以黃金標準整合酶抑製劑為核心。

  • In the U.S., we saw strong double-digit volume growth driven by long-acting, partially offset by some impact from the implementation of the IRA and from channel mix. Our leading Oral 2 drug regimen, Dovato, continued to grow strongly in all regions at 19%. While our long-acting injectables, Cabenuva and Apretude, grew 38% and 63%, respectively. We remain delighted with the strong and continued momentum of our long-acting portfolio.

    在美國,我們看到在長效藥物的推動下,銷量實現了強勁的兩位數成長,但被 IRA 實施和通路組合的一些影響部分抵消。我們領先的口服 2 型藥物方案 Dovato 在所有地區繼續強勁增長,增幅達 19%。我們的長效注射劑 Cabenuva 和 Apretude 分別增加了 38% 和 63%。我們對我們的長期投資組合的強勁和持續發展勢頭感到高興。

  • Cabenuva is the first and only approved long-acting injectable regimen for the treatment of HIV with 77,000 patients globally now benefiting from this transformative medicine. We shared data at the CROI Conference in March, demonstrating Cabenuva's high long-term effectiveness in real-world studies, including almost 15,000 people living with HIV. These data underline the high patient preference and treatment satisfaction for Cabenuva compared to daily pills.

    Cabenuva 是首個也是唯一一個獲準的用於治療愛滋病毒的長效注射療法,目前全球已有 77,000 名患者受益於這種變革性藥物。我們在 3 月的 CROI 會議上分享了數據,證明了 Cabenuva 在現實世界研究中的長期高有效性,其中包括近 15,000 名 HIV 感染者。這些數據強調了與每日服用的藥片相比,Cabenuva 具有更高的患者偏好度和治療滿意度。

  • Apretude, the first and only approved long-acting option for HIV prevention, is now benefiting 21,000 individuals in the U.S. We remain confident in the competitive profile and growth of Apretude, with strong efficacy at more than 99%, safety, and importantly, overall tolerability across broad populations.

    Apretude 是第一個也是唯一一個核准的長效 HIV 預防藥物,目前正惠及美國 21,000 人。我們對 Apretude 的競爭優勢和成長前景充滿信心,其療效高達 99% 以上,安全性高,更重要的是,在廣大人群中具有良好的整體耐受性。

  • At CROI, we also shared implementation study data showing zero cases of HIV acquisition as well as high persistence addressing adherent challenges some face with orals.

    在 CROI,我們也分享了實施研究數據,顯示 HIV 感染病例為零,並且高度堅持解決一些人在口服藥物時面臨的堅持挑戰。

  • The potential for the long-acting market remains significant, with the total HIV market today worth more than GBP22 billion, and with treatment accounting for 90% of this. We expect the use of long-acting injectables to continue to rise significantly through strong patient demand, physician belief in the unique benefits, and increased infrastructure to support their administration.

    長效市場潛力仍然巨大,目前愛滋病毒市場總價值超過 220 億英鎊,其中治療佔 90%。我們預計,由於患者的強烈需求、醫生對其獨特益處的信任以及支持其管理的基礎設施的增強,長效注射劑的使用將繼續大幅增加。

  • Given the strong start to the year, we remain confident in our 2025 guidance of mid-single-digit percentage growth driven by strong volume growth, partly offset by pricing dynamics through the IRA and channel mix.

    鑑於今年開局強勁,我們仍然對 2025 年的預期充滿信心,即在強勁的銷量增長的推動下,實現中等個位數百分比增長,但 IRA 和渠道組合的定價動態會部分抵消這一增長。

  • Next slide please. At CROI, we shared exciting data highlighting our great HIV pipeline progress, including three high-potential assets in our treatment pipeline. Delivering the best resistance profile of any INSTI we've seen to-date, we were delighted with the Phase 2a data for our third generation INSTI, VH184. Results demonstrated rapid and high potency, positive safety results, and no drug-resistant mutations. This promising early data supports further development of VH184 as the backbone of our next generation of HIV treatment regimens with IP cover through to 2039.

    請看下一張投影片。在 CROI,我們分享了令人興奮的數據,重點介紹了我們在 HIV 治療領域取得的巨大進展,其中包括治療領域中的三種高潛力資產。這是我們迄今為止所見過的所有 INSTI 中抗性最好的,我們對第三代 INSTI VH184 的 2a 階段數據感到非常滿意。結果表明,該藥物療效迅速、效力高、安全性好,且無抗藥性突變。這些有希望的早期數據支持進一步開發 VH184,作為我們下一代 HIV 治療方案的支柱,並將 IP 覆蓋至 2039 年。

  • We also shared Phase 2b data showing our bNAb, N6LS, achieved high efficacy and tolerability. These results, combined with pharmacokinetic data, support progressing this asset to explore six monthly dosing. We look forward to seeing Q6M data in the next phase of this study.

    我們也分享了 2b 期數據,顯示我們的 bNAb N6LS 實現了高效能和耐受性。這些結果與藥物動力學數據相結合,支持推進此項資產以探索六個月的給藥方案。我們期待在該研究的下一階段看到 Q6M 數據。

  • Moving on to VH499, our investigational capsid inhibitor. Data from a Phase 2a study also showed potent antiviral activity and favorable safety, again supporting further development of this asset.

    接下來介紹我們正在研究的衣殼抑制劑 VH499。階段 2a 研究的數據也顯示出強大的抗病毒活性和良好的安全性,再次支持該資產的進一步開發。

  • With these multiple data readouts, we remain on track to confirm the assets that will deliver six monthly dosing for treatment in 2026 with our Q6M registrational study start planned in 2027. As you can see on the slide, we expect our Q6M regimen to contain a combination of one of three long-acting INSTIs, CAB LA, VH184, or VH310, with either our bNAb N6LS or VH499, our capsid inhibitor.

    透過這些多個數據讀數,我們仍有望確認將在 2026 年提供六個月劑量治療的資產,並計劃於 2027 年開始 Q6M 註冊研究。正如您在幻燈片上看到的,我們預計我們的 Q6M 方案將包含三種長效 INSTI(CAB LA、VH184 或 VH310)中的一種與我們的 bNAb N6LS 或 VH499(我們的衣殼抑制劑)的組合。

  • And then turning to Q4M, our prep bridging study is fully recruited. We expect data in mid-2026. And we anticipate starting our Q4M treatment registrational study by the end of this year.

    然後轉向 Q4M,我們的預科橋接研究已經全面招募完成。我們預計數據將在 2026 年中期公佈。我們預計今年底開始 Q4M 治療註冊研究。

  • As pioneers in long-acting injectables, we are focused on the next generation of HIV innovation with integrase inhibitors, the gold standard for HIV treatment and prevention at the core. We remain confident that our pipeline, including three new INSTIs in development and five planned launches, will continue to drive performance over the coming decade. And we will share more at the Meet the Management event in Q2 2026.

    作為長效注射劑的先驅,我們專注於下一代 HIV 創新,以整合酶抑制劑為核心,這是 HIV 治療和預防的黃金標準。我們堅信,我們的產品線(包括三種正在開發中的新型 INSTI 和五種計劃推出的 INSTI)將在未來十年繼續推動業績成長。我們將在 2026 年第二季的「與管理層見面」活動中分享更多資訊。

  • With that, I will hand back to Luke.

    說完這些,我就把話還給盧克。

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Thanks, David. Turning to Vaccines, sales for Q1 were over GBP2 billion, down 6% on last year in line with expectations. Shingrix sales declined 7%, with growth in Europe partially offsetting lower sales in the U.S. and international. As anticipated, the pace of penetration in the U.S. is slowing, given the immunization rate reaching 41% at the end of 2024.

    謝謝,大衛。談到疫苗,第一季的銷售額超過 20 億英鎊,比去年下降 6%,符合預期。Shingrix 的銷售額下降了 7%,歐洲的成長部分抵消了美國和國際銷售額的下降。正如預期的那樣,鑑於 2024 年底的免疫率將達到 41%,美國的滲透速度正在放緩。

  • Sales in international were impacted by the annualization of rapid uptake from the national immunization program in Australia in quarter one 2024, and the agreed lower supply to our co-promotion partner in China. In Europe, strong growth was driven by the excellent launch in France and good performances in other European markets, including Spain, the Netherlands, Italy, and Greece.

    2024 年第一季度,澳洲國家免疫計畫的快速實施年化以及與我們在中國的聯合推廣夥伴商定的供應量減少,影響了國際銷售。在歐洲,強勁的成長得益於法國的出色上市以及西班牙、荷蘭、義大利和希臘等其他歐洲市場的良好表現。

  • Shingrix is now launched in 54 markets with recommendations in more than 40 markets and national reimbursement programs in 24. Growth outside the U.S. this year will be supported by expanded funding, the launch in France, and a new Japanese national subsidy for shingles vaccination. The average immunization rate across the top 10 markets outside the U.S. is now around 8%, so there's still a significant opportunity for Shingrix ahead.

    Shingrix 目前已在 54 個市場推出,並在 40 多個市場獲得推薦,並在 24 個國家納入國家報銷計畫。今年,美國以外市場的成長將受到資金增加、法國市場上市以及日本新推出的帶狀皰疹疫苗國家補貼的支持。目前,美國以外十大市場的平均免疫接種率約為 8%,因此 Shingrix 未來仍有巨大的發展機會。

  • In meningitis, our portfolio was up 20% in Q1, with strong double-digit growth across Europe and international, primarily driven by Bexsero. In February, we received U.S. FDA approval of our new (inaudible) vaccine, Penmenvy, and we're pleased to also have received a unanimous recommendation from the Advisory Committee on Immunization Practices or ACIP to the CDC. And in time, we expect this vaccine to simplify immunization schedules, increasing coverage and protection against a serious life-threatening illness.

    在腦膜炎方面,我們的投資組合在第一季成長了 20%,在歐洲和國際上實現了強勁的兩位數成長,這主要得益於 Bexsero。今年 2 月,我們的新型(聽不清楚)疫苗 Penmenvy 獲得了美國 FDA 的批准,我們也很高興收到了美國疾病管制與預防中心免疫實踐諮詢委員會 (ACIP) 的一致推薦。隨著時間的推移,我們期望這種疫苗能夠簡化免疫接種計劃,提高覆蓋率並預防嚴重的危及生命的疾病。

  • Turning to RSV, Arexvy sales were down 57% in the quarter against a challenging comparator and the impact of restricted ACIP recommendations. However, Arexvy continues to be the U.S. market leader, retaining 55% of the adult vaccination share. Two weeks ago, ACIP voted unanimously to recommend adults aged 50 to 59 at an increased risk to receive an RSV vaccine.

    談到 RSV,與具有挑戰性的比較對像以及限制性 ACIP 建議的影響相比,Arexvy 的銷售額在本季度下降了 57%。不過,Arexvy 仍然是美國市場的領導者,佔據了 55% 的成人疫苗接種份額。兩週前,ACIP 一致投票建議 50 至 59 歲高風險成年人接種 RSV 疫苗。

  • We welcome the expanded recommendation which opens up access to a cohort of around 13 million people in the U.S. Although in the current vaccines environment, we don't expect a significant upside this year and this market will take time to build, but we remain confident in the long-term importance of this vaccine.

    我們歡迎擴大建議,這將使美國約 1,300 萬人能夠接種疫苗。儘管在當前的疫苗環境下,我們預計今年不會有顯著的成長,而且這個市場需要時間來建立,但我們仍然對這種疫苗的長期重要性充滿信心。

  • We also presented a 36-month immune response data from a ADJ-004 study, and the data provided evidence to support future re-vaccination with Arexvy underpinning our strong belief that a re-vaccination will be required with our base case at five years. We also expect more data on this in 2026.

    我們還提供了 ADJ-004 研究的 36 個月免疫反應數據,這些數據提供了支持未來重新接種 Arexvy 的證據,這鞏固了我們堅信在五年基本情況下需要重新接種疫苗的信念。我們也預計 2026 年將獲得更多相關數據。

  • Outside the U.S., Arexvy have launched in 37 markets with recommendations in 18 of these markets, and national reimbursement programs in 6, with more to come. Although it's pre-season, we are seeing some early access momentum outside the U.S. and particularly in Germany following recommendation and reimbursement.

    在美國以外,Arexvy 已在 37 個市場推出,其中 18 個市場獲得推薦,並在 6 個市場推出國家報銷計劃,未來還將推出更多市場。儘管現在還處於季前階段,但我們看到美國以外地區,尤其是德國,在推薦和報銷之後,出現了一些搶先體驗的勢頭。

  • As expected, established vaccine sales were impacted by non-repeating prior-year sales, partially offset by high U.S. demand for our measles, mumps, and rubella vaccine. Overall, we continue to expect vaccine sales to decrease low single-digit percent in 2025, while remaining confident in the medium to long-term prospects of this business and pipeline.

    正如預期的那樣,現有的疫苗銷售受到了去年同期非重複銷售的影響,但美國對我們的麻疹、腮腺炎和德國麻疹疫苗的高需求部分抵消了這一影響。總體而言,我們仍預期 2025 年疫苗銷售額將下降低個位數百分比,同時對該業務和產品線的中長期前景仍充滿信心。

  • Next slide please. Turning to General Meds, Respiratory sales were up 1%, driven by Trelegy, which was up 15%, which benefited from a continued patient demand, SITT class growth, and increased market share. Trelegy is the number one brand in asthma and COPD worldwide, and it's the cornerstone of our COPD treatment portfolio and is soon to be complemented by our new biologics that are an add-on to Trelegy standard of care, cementing our leadership in the COPD space and reflecting our long legacy of leadership in respiratory health.

    請看下一張投影片。談到通用藥物,呼吸系統藥物銷售額增長了 1%,其中 Trelegy 銷售額增長了 15%,這得益於持續的患者需求、SITT 類別的增長以及市場份額的增加。Trelegy 是全球氣喘和 COPD 領域的頭號品牌,也是我們 COPD 治療產品組合的基石,並且很快將透過我們的新生物製劑進行補充,這些新生物製劑是對 Trelegy 護理標準的補充,鞏固了我們在 COPD 領域的領導地位,並反映了我們在呼吸健康領域的長期領導地位。

  • Overall, General Medicines sales were stable in the quarter, with other General Medicines down around 3% owing to continued generic competition as expected.

    總體而言,本季通用藥物銷售額保持穩定,但其他通用藥物銷售額因仿製藥競爭持續而下降約 3%,這與預期一致。

  • In March, we received FDA approval of Blujepa, a new antibiotic treatment to treat uncomplicated urinary tract infections. We're on track to launch in the second half, and we'll focus on building access over time. Later this year, we'll be pursuing a regulatory decision for the second indication in urogenital gonorrhea, and we plan to build on our anti-infectious portfolio in the coming years. Overall, for the Gen Meds portfolio, we continue to anticipate sales to be broadly stable in 2025.

    3 月份,我們獲得了 FDA 對 Blujepa 的批准,這是一種用於治療單純性泌尿道感染的新型抗生素療法。我們將在下半年推出該產品,並將致力於逐步建立存取權限。今年晚些時候,我們將針對泌尿生殖系統淋病的第二種適應症尋求監管決定,並計劃在未來幾年擴大我們的抗感染產品組合。總體而言,對於 Gen Meds 產品組合,我們繼續預期 2025 年的銷售額將基本保持穩定。

  • I'll now hand over to Julie.

    我現在將麥克風交給茱莉。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Thank you, Luke. And good afternoon, everyone. Next slide please. Starting with the income statement for the quarter with growth rates stated at CER, GSK has started 2025 well, carrying momentum through from 2024 with sales increasing 4% and core operating profit growing 5%, against a very strong comparator base of 35% growth last year. Sales benefited from the continued strength of Specialty, up 17%, more than offsetting the expected decline in Vaccines. Volume growth more than offset price erosion, stemming from the Medicare Part D redesign implemented at the start of the year. And as Luke mentioned, the impact of this through the first quarter was in line with our expectations.

    謝謝你,盧克。大家下午好。請看下一張投影片。從以固定匯率計算的成長率計算的季度損益表來看,葛蘭素史克在 2025 年取得了良好的開端,延續了 2024 年的勢頭,銷售額增長了 4%,核心營業利潤增長了 5%,而去年的比較基數非常強勁,增長了 35%。銷售額受益於特種產品持續強勁成長,成長了 17%,超過了疫苗業務的預期下滑。由於今年年初實施的聯邦醫療保險 D 部分重新設計,銷售成長足以抵消價格下跌的影響。正如盧克所提到的,這對第一季的影響符合我們的預期。

  • Turning to the income statement. We have delivered another 25% of operating leverage. Gross profit benefited from product mix as the portfolio continues to transition towards higher margin Specialty Medicines. SG&A increased 8% year-on-year, but 4% excluding the Zejula royalty credit last year. And royalty growth was up 21%, driven by prior year true-ups. These factors have supported the delivery of 5% operating profit in EPS growth or 8% operating profit growth, excluding the Zejula credit.

    轉向損益表。我們又實現了25%的經營槓桿。隨著產品組合繼續向利潤率更高的特種藥品轉型,毛利受益於產品組合。銷售、一般及行政費用年增 8%,但如果不包括去年 Zejula 特許權使用費抵免,則增長 4%。受上年實際成長的推動,特許權使用費增加了 21%。這些因素支持了每股收益成長 5% 的營業利潤或 8% 的營業利潤成長(不包括 Zejula 信貸)。

  • Turning to the total results. The significant growth in operating profit predominantly resulted from lower CCL charges compared to last year and foreign currency movements.

    轉向整體結果。營業利潤的大幅成長主要源自於 CCL 費用較去年同期下降以及外匯變動。

  • Next slide please. This chart illustrates the substantial margin progression we have continued to deliver on an underlying basis, driven by benefits from the transition to Specialty Medicines as well as our ongoing disciplined returns-based approach to investment. Core operating margin improved to 33.5%, up 130 bps, excluding the prior-year Zejula credit, or 30 bps year-on-year in total. Accretion was driven by mix as gross margin benefited from the strong growth of higher margin Specialty Medicines, including one-off benefits from Nucala and Benlysta comparative basis, as Luke mentioned.

    請看下一張投影片。這張圖表表明,在向特種藥品轉型帶來的好處以及我們持續嚴謹的基於回報的投資方式的推動下,我們持續實現了大幅的利潤成長。核心營業利潤率提高至 33.5%,上漲 130 個基點(不包括上年的 Zejula 信貸),或年比總計上漲 30 個基點。正如 Luke 所提到的,成長是由組合推動的,因為毛利率受益於利潤率更高的特種藥品的強勁增長,包括 Nucala 和 Benlysta 比較基礎帶來的一次性收益。

  • We continue to invest in our key products, including Blenrep, depemokimab, and Ojjaara, with underlying SG&A rising broadly in line with sales. And for the full year, we expect sga to grow a low single digits as we allocate resources to support our launches over the coming 12 months. R&D grew marginally below sales this quarter and is expected to accelerate as we progress through 2025, driven by investment in our next wave of key specialty pipeline assets.

    我們繼續投資於我們的關鍵產品,包括 Blenrep、depemokimab 和 Ojjaara,其基礎銷售、一般及行政費用與銷售額基本同步成長。就全年而言,我們預計 SGA 將實現較低的個位數成長,因為我們將分配資源來支援未來 12 個月的發布。本季研發成長略低於銷售額,預計隨著我們進入 2025 年,研發成長將會加速,這得益於我們對下一波關鍵專業管道資產的投資。

  • Next slide please. Turning to cash flow with commentary before the one-off impact of Zantac payments. Cash generated from operations was GBP1.4 billion. CGFO improved 0.2% of GBP1 billion reflecting higher operating profit and favorable movements in RAR, partially offset by adverse movements in receivables driven by higher Arexvy and Shingrix collections last year.

    請看下一張投影片。在 Zantac 付款的一次性影響之前,轉向現金流並進行評論。經營活動產生的現金為14億英鎊。總財務總監成長了 0.2%,達到 10 億英鎊,這反映了更高的營業利潤和 RAR 的有利變動,但部分被去年 Arexvy 和 Shingrix 收款增加導致的應收帳款的不利變動所抵消。

  • Free cash flow improved by 0.5% of GBP1 billion excluding Zantac, supported by a favorable CapEx comparator that included upfront BD payments last year to Hansoh. Zantac payments this quarter totaled GBP62 million, and we now expect GBP1.2 billion of payments to be phased over the remainder of 2025, with 0.5% of GBP1 billion expected in Q2.

    不包括 Zantac 在內的自由現金流增加了 0.5%,即 10 億英鎊,這得益於有利的資本支出比較器(包括去年向 Hansoh 支付的預付 BD 款項)。本季 Zantac 的付款總額為 6,200 萬英鎊,我們目前預計 2025 年剩餘時間內將分階段支付 12 億英鎊,其中預計第二季將支付 10 億英鎊中的 0.5%。

  • Next slide please. Through the quarter, we've continued to deploy cash in line with our capital allocation framework, whilst ensuring this remains underpinned by a strong balance sheet. Free cash generation pre-CapEx was over GBP1 billion, which supported investment in our oncology pipeline through the purchase of IDRx, as Emma mentioned earlier, and our continuing commitment to shareholder returns. We have returned over 0.8% of GBP1 billion to shareholders through the dividend and the buyback where we completed nearly a 0.25% of GBP1 billion in Q1. We remain committed to investing for growth and providing attractive and growing shareholder returns.

    請看下一張投影片。整個季度,我們繼續按照資本配置框架部署現金,同時確保強勁的資產負債表為其提供支援。資本支出前的自由現金產生量超過 10 億英鎊,正如 Emma 之前提到的,這支持了我們透過收購 IDRx 對腫瘤學管道的投資,以及我們對股東回報的持續承諾。我們透過股息和回購向股東返還了超過 10 億英鎊的 0.8%,其中第一季我們完成了近 10 億英鎊的 0.25%。我們將繼續致力於投資成長並提供有吸引力且不斷增長的股東回報。

  • Next slide please. We're very pleased with the business performance which, as outlined, was driven by strong growth of key products and higher-than-anticipated royalties. These results reinforce our confidence in the delivery of our full-year 2025 guidance of 3% to 5% sales growth and 6% to 8% operating profit and EPS growth. Royalty income for the year is now expected to be higher than previously guided, at GBP750 million to GBP800 million, including an IP settlement relating to RSV agreed in April, comprising an upfront to be credited in Q2 and a future royalty stream. This additional income will be reinvested in the pipeline this year, with R&D investment growth now expected to be slightly ahead of sales.

    請看下一張投影片。我們對業務表現非常滿意,正如概述的那樣,這得益於關鍵產品的強勁增長和高於預期的特許權使用費。這些結果增強了我們對實現 2025 年全年銷售額成長 3% 至 5% 以及營業利潤和每股收益成長 6% 至 8% 的預期的信心。目前預計今年的特許權使用費收入將高於先前的預期,達到 7.5 億至 8 億英鎊,其中包括 4 月達成的與 RSV 相關的智慧財產權和解,其中包括將在第二季記入的預付款和未來的特許權使用費流。這筆額外收入將重新投資於今年的研發項目,預計研發投資成長將略高於銷售額。

  • In terms of phasing, we continue to expect profit growth to be second half-weighted, albeit to a lesser extent than previously anticipated, with Q2 now benefiting from the IP settlement. More details around phasing and the modeling assumptions are contained within the Appendix.

    從分階段來看,我們仍然預期利潤成長將受到下半年的影響,儘管幅度低於先前的預期,但第二季目前受益於智慧財產權結算。有關分階段和建模假設的更多詳細資訊包含在附錄中。

  • Looking beyond, we remain confident in our medium and longer term outlooks to 2026 and 2031. Should tariffs be imposed, as Emma mentioned, we are well-prepared and start from a position of strength. We have identified potential mitigating options in supply chain and increased productivity initiatives. And we remain committed to sustained investment in our pipeline and launches.

    展望未來,我們對 2026 年和 2031 年的中長期前景仍然充滿信心。如果徵收關稅,正如艾瑪所提到的,我們已經做好了充分的準備,並且處於強勢地位。我們已經確定了供應鏈中潛在的緩解措施和提高生產力的措施。我們將繼續致力於對我們的產品線和產品發布進行持續投資。

  • Next slide please. Turning to our road map. On the back of 13 positive Phase 3 readouts last year, GSK has carried pipeline momentum into Q1, with two new U.S. approvals as highlighted. Looking ahead, we expect three more approvals for Nucala (COPD), Blenrep, and depemokimab this year, with PDUFA dates in May, July, and December, respectively. We expect all three to be important growth drivers for GSK. And over the next two years, we expect this momentum to continue as our pipeline delivers new growth drivers, and we look forward to 15 Phase 3 and pivotal study readouts in respiratory hepatitis, long-acting HIV, and oncology.

    請看下一張投影片。轉向我們的路線圖。憑藉去年 13 份積極的 3 期臨床試驗數據,葛蘭素史克將研發管線的強勁勢頭帶入了第一季度,其中最引人注目的是獲得了兩項新的美國批准。展望未來,我們預計今年將有三項 Nucala(COPD)、Blenrep 和 depemokimab 獲得批准,PDUFA 日期分別為 5 月、7 月和 12 月。我們預計這三者都將成為葛蘭素史克的重要成長動力。在接下來的兩年裡,隨著我們的產品線提供新的成長動力,我們預計這種勢頭將繼續下去,我們期待在呼吸道肝炎、長效愛滋病毒和腫瘤學領域獲得 15 項 3 期和關鍵研究的讀數。

  • And with that, I will hand back to Emma for her closing remarks.

    最後,我將把發言權交還給艾瑪,請她作最後發言。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Thanks, Julie. So to summarize, GSK is delivering with a good start to the year. Momentum in our portfolio is supporting our ability to continue to deliver mixed improvement, operating leverage, and cash flow. Despite the environmental uncertainty, we continue to expect 2025 to be another year of profitable growth. And we remain very focused on investing in the pipeline, targeted business development, and successful launches to fuel further growth to achieve our potential and more for patients, shareholders, and our people.

    謝謝,朱莉。總而言之,葛蘭素史克今年取得了良好的開端。我們投資組合的勢頭支持我們繼續實現混合改進、經營槓桿和現金流的能力。儘管環境存在不確定性,我們仍然預期 2025 年將是另一個獲利成長的一年。我們仍然非常注重投資管道、有針對性的業務開發和成功發布,以推動進一步成長,發揮我們的潛力,並為患者、股東和員工提供更多服務。

  • Thank you very much. And with that, we will now open up the call for Q&A with the team.

    非常感謝。現在,我們將開始與團隊進行問答。

  • Constantin Fest - Senior Vice President, Head-Investor Relations

    Constantin Fest - Senior Vice President, Head-Investor Relations

  • Thank you, Emma. (Event Instructions)

    謝謝你,艾瑪。(活動須知)

  • James Gordon, J.P. Morgan.

    詹姆斯·戈登,J.P. 摩根。

  • James Gordon - Analyst

    James Gordon - Analyst

  • Thanks a lot. James Gordon, J.P. Morgan. Thanks for taking two questions. First question would be new launch expectations. So two important approval decisions coming up: Nucala COPD, May 7; and Blenrep, July 23. So assuming things are still operating as normal with FDA and you get the timely approvals, what are your latest thoughts in terms of how those launches go? What are the gating factors and best precedents for how they go? And could we see strong uptake already in H2 or are these more of 2026 stories? I guess I'm think for Blenrep, could ocular talks and education around that or other things you need to do around that be a barrier to a fast launch? And for Nucala, (inaudible) COPD the precedent? That's the first question, please.

    多謝。詹姆斯·戈登,J.P. 摩根。感謝您回答兩個問題。第一個問題是新品發布預期。因此即將做出兩個重要的批准決定:Nucala COPD,5 月 7 日;以及 Blenrep,7 月 23 日。因此,假設 FDA 一切仍然正常運作並且您及時獲得批准,您對這些產品的發布進度有何最新想法?它們如何發展的限制和最佳先例是什麼?我們是否已經看到下半年出現強勁成長,還是這只是 2026 年的故事?我想對於 Blenrep 來說,圍繞這一問題進行的口頭討論和教育,或者圍繞這一問題需要做的其他事情,是否會成為快速啟動的障礙?對 Nucala 來說,(聽不清楚)COPD 是先例嗎?這是第一個問題。

  • And the second question is on tariffs. So I heard the comments of being well-positioned and also that there could be some mitigating options and productivity offsets. So can you elaborate like what would the impact be, let's say, it's a 25% tariff on bringing products from outside the U.S. into the U.S., what would the impact be on GSK and how quickly could you have these sort of offsets or productivity benefits? Would it be that you'd actually move U.S. manufacturing or something else? And is there like an inventory or other cushion, is that what you could be referring to?

    第二個問題是關於關稅的。因此,我聽到了有關處於有利地位的評論,並且還說可能會有一些緩解措施和生產力補償。那麼,您能否詳細說明一下會產生什麼影響呢?假設對從美國境外進口的產品徵收 25% 的關稅,這會對葛蘭素史克產生什麼影響?您多快能獲得這種補償或生產力效益?您是否真的會轉移美國製造業或其他產業?是否存在庫存或其他緩衝,這就是您所指的嗎?

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • All right. There's quite a lot in there, but let's start with what matters most which is the exciting new launches we're bringing across that portfolio. Luke, perhaps you'd like to kick off there. And then I'll come back on to tariffs.

    好的。其中有很多內容,但讓我們從最重要的內容開始,即我們在整個產品組合中推出的令人興奮的新產品。盧克,也許你想從那裡開始。然後我再來談談關稅問題。

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Sure, Emma. Thanks, James. Yeah, a lot there. So I'll cover in order. And Tony, jump in if I miss anything. I'll go through Nucala first. I think I'll touch on Penmenvy because we'll get questions on that; Depemokimab and Blenrep. I won't cover Blujepa because I covered that in the opening intro. I think first with Nucala (COPD), I mean, yeah, May 7 PDUFA is on track. The MATINEE data is going to be published very soon. So it's limited what I can say. But in big picture terms, in terms of apples to apples comparison to Dupi, I think we're very competitive. We also had a wide spectrum of patients, so emphysemia, combined emphysemia, and chronic bronchitis patients, and then singular chronic bronchitis patients as well. So from a physician point of view, that's very appealing because it can be difficult to stratify these patients at time. So that's simpler for their practice.

    當然,艾瑪。謝謝,詹姆斯。是的,有很多。因此我將按順序介紹。東尼,如果我遺漏了什麼,請告訴我。我將首先經過努卡拉 (Nucala)。我想我會談談 Penmenvy,因為我們會對此提出問題; Depemokimab 和 Blenrep。我不會介紹 Blujepa,因為我在開場介紹中已經介紹過了。我認為首先是 Nucala (COPD),我的意思是,是的,5 月 7 日的 PDUFA 進展順利。MATINEE 數據即將發布。所以我能說的很有限。但從總體上看,與杜皮進行同類比較,我認為我們非常有競爭力。我們的患者範圍也很廣泛,包括肺氣腫、混合性肺氣腫和慢性支氣管炎患者,以及單一慢性支氣管炎患者。因此,從醫生的角度來看,這非常有吸引力,因為有時很難對這些患者進行分層。這對他們的練習來說更簡單。

  • The important thing, when results are released, the trial was designed to look at hospitalization and emergency department visits which the GP studies didn't in their protocol design. So that's an important measure when you look at pulmonologists and what they consider to be critical when they're employing a biologic in these refractory patients. If you look at market research, it's very supportive, and that's grown over time. About 83% of pulmonologists, when we show them the profile of the product, are very motivated to use Nucala (COPD). Now, I would counter this with pulmonologists generally are pretty conservative in their usage of biologics. I said earlier, around 21%. So I think that needs to be, in terms of your (inaudible), factored in.

    重要的是,當結果公佈時,該試驗旨在關注住院和急診就診情況,而全科醫生研究在其方案設計中並未考慮這一點。因此,當你觀察肺病專家時,這是一個重要的衡量標準,當他們對這些難治性患者使用生物製劑時,他們認為這是至關重要的。如果你看一下市場調查,你會發現它非常具有支持性,而且隨著時間的推移,它還在不斷增長。當我們向大約 83% 的肺科醫生展示該產品的概況時,他們非常願意使用 Nucala(慢性阻塞性肺病)。現在,我要反駁這一點,肺科醫生在使用生物製劑時一般都相當保守。我之前說過,大約21%。因此,我認為,就你的(聽不清楚)而言,這需要被考慮進去。

  • The other thing we've done, of course, (inaudible), we're looking very, very closely at Dupi, where their access is, the user base, why people are using it. So I think we're very much looking forward to the launch. We've had a whole successful series of indications and expansions with Nucala. So the capacity of doing this is, I think, we've got a good track record. So we're looking forward to having fun with competing against Sanofi there.

    當然,我們做的另一件事(聽不清楚)是,我們正在非常密切地關注 Dupi,他們的訪問權限在哪裡,用戶群,以及人們使用它的原因。所以我認為我們非常期待這次發布。我們與 Nucala 合作完成了一系列成功的適應症和擴展。所以我認為,我們在這方面的能力有著良好的記錄。因此,我們期待在那裡與賽諾菲競爭。

  • In terms of Penmenvy --

    就 Penmenvy 而言--

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Luke, sorry, just one additional point to stress for the study, and as you say, we're looking forward to presenting the the data very soon now. Important to recognize that the study was conducted over a two-year period. That is critical for a disease whose survival rate of five-years is only 50%.

    路克,抱歉,關於這項研究我只想強調一點,正如你所說,我們期待很快就能呈現數據。重要的是要認識到這項研究是在兩年內進行的。對於五年存活率僅 50% 的疾病來說,這一點至關重要。

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Absolutely. And I think 11% mortality rate if you are admitted, which again is why when we do the surveys with physicians, they cite hospitalization as a key parameter.

    絕對地。我認為住院死亡率為 11%,這也是為什麼當我們對醫生進行調查時,他們將住院率作為關鍵參數。

  • Okay. Now in terms of Penmenvy, so that's our pentavalent meningitis vaccine, just as a reminder, we have a very strong position as a global leader in meningitis. And with Bexsero men B vaccine, we get about 75% market share in the U.S. And that's really driven by it's 110-strand coverage and it's really perceived to be the stronger of the two men B vaccines. That's important because when you deploy or use a pentavalent vaccine, you need to use -- with the subsequent B follow-up that I'll explain in a minute, you need to use the B vaccine that was embedded in that pentavalent, which we believe gives us a good position.

    好的。現在就 Penmenvy 而言,這是我們的五價腦膜炎疫苗,提醒一下,我們在腦膜炎領域擁有非常強大的全球領先地位。憑藉 Bexsero 男性 B 型疫苗,我們在美國獲得了約 75% 的市場份額。這主要是因為它具有 110 鏈覆蓋率,而且它被認為是兩種男性 B 型疫苗中效力更強的一種。這很重要,因為當你部署或使用五聯疫苗時,你需要使用——我稍後會解釋的後續 B 疫苗跟進,你需要使用嵌入在五聯疫苗中的 B 疫苗,我們相信這給了我們一個很好的定位。

  • So we've passed the first of two steps, so FDA approval and then the ACIP recommendation on April 16. The schedule that's signed off is the same as Pfizer's and I mean it is more complex and ACIP has signaled that they intend to evolve this, which I'll come back to in a minute. But basically, if you look at the numbers today, first shot is with ACWY which is stipulated as a routine vaccine by ACIP in the U.S. So about 90% of kids in the U.S. actually get that vaccine. Then when you sort of have these kids progress to 16 to 18 years of age, so adolescents, the schedule is that they should have ACWY as a routine. And today, about 60% of those kids get that vaccine. So quite a big drop off.

    因此,我們已經通過了兩個步驟中的第一步,即 FDA 批准,然後是 4 月 16 日的 ACIP 建議。簽署的時間表與輝瑞的時間表相同,我的意思是它更加複雜,ACIP 已表示他們打算改進它,我稍後會再談到這一點。但基本上,如果你看看今天的數字,第一針是 ACWY,它被美國 ACIP 規定為常規疫苗。因此,大約 90% 的美國兒童實際上都接種了這種疫苗。然後,當這些孩子長到 16 至 18 歲時,也就是青少年時期,他們應該定期參加 ACWY。如今,大約有 60% 的兒童接種了該疫苗。因此下降幅度相當大。

  • Now the position at that point, based on shared clinical decision making, can either use, well, can use a B shot and around 32% of kids get that shot in the U.S. And then there's a subsequent follow-up second booster shot with meningitis B. But only about 13% of adolescents or children in the U.S. get that one. So quite a substantial drop off from 90% down to 13%, despite the fact that B is a very, very challenging and potentially lethal strain.

    現在,基於共同的臨床決策,目前的立場是可以使用 B 針疫苗,在美國大約有 32% 的兒童接種了這種疫苗。然後是後續的第二針腦膜炎雙球菌加強劑。但在美國,只有大約 13% 的青少年或兒童接種了這種疫苗。儘管 B 型病毒株極具挑戰性且具有致命性,但感染率仍從 90% 大幅下降至 13%。

  • So what ACIP signed off on the other day was that instead of that ACWY/B combo in after that initial ACWY shot, using shared clinical decision making, the pediatrician can elect to use a penta vaccine, like Penmenvy. And then follow that up with a B. So if you're confused at this point, again, a lot of pediatricians are confused, they have to stop four vaccines.

    因此,ACIP 前幾天簽署的協議是,在初次 ACWY 注射後,兒科醫生可以使用共享臨床決策,選擇使用五聯疫苗(例如 Penmenvy),而不是使用 ACWY/B 組合疫苗。然後接著是 B。所以如果你在這一點上感到困惑,同樣,很多兒科醫生也感到困惑,他們必須停止接種四種疫苗。

  • Now, where ACIP has indicated where they want to go, and that's the third step, it's a simpler regime where basically, it would be ACWY initially, but the penta and then B follow-up would be risk-based. And that's an important shift. Because with risk-based, that supports a broader use. It enables physicians to look specifically into who should be vaccinated. So for example, 18-year-old going off to college would be a classic there. And it's an opportunity for us to expand coverage.

    現在,ACIP 已經表明了他們想要去的地方,這是第三步,這是一個更簡單的製度,基本上,最初是 ACWY,但五項和 B 後續行動將基於風險。這是一個重要的轉變。因為基於風險,所以支援更廣泛的使用。它使醫生能夠具體了解誰應該接種疫苗。舉個例子,18 歲去上大學就是一個典型的例子。這是我們擴大覆蓋範圍的一個機會。

  • So again, initial rolling launch now with Penmenvy will be relatively small because of this change that pediatricians and payers are waiting for. And the aim is ACIP has signaled that they will look at that in October or early next year. So hopefully, they cover that in October.

    因此,由於兒科醫生和付款人正在等待這一變化,Penmenvy 的初始滾動發布規模將相對較小。ACIP 已表示,他們的目標是在 10 月或明年年初研究這個問題。所以希望他們能在十月解決這個問題。

  • Okay. Third one, anything on that one, Tony?

    好的。第三個問題,東尼,對此有什麼看法嗎?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • No, you're good,

    不,你很好,

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • So depemokimab, very, very exciting. I think the more that this product is profiled, remember, we can't promote these products if they're not approved, physicians get access to the data through academic congresses, publications, et cetera. And again, I think the main problem when you look at biologics is just the lack of penetration despite excellent insurance coverage and really high burden for these patients in terms of severe disease, exacerbations, hospital admission. But still, as I said earlier, only 21% of patients get a biologic.

    所以 depemokimab 非常非常令人興奮。我認為,該產品的介紹越多,請記住,如果未獲得批准,我們就不能推廣這些產品,醫生可以透過學術會議、出版物等獲取數據。再說一次,我認為生物製劑的主要問題是儘管保險覆蓋率廣,但滲透率仍然不足,而且這些患者在重症、病情加重、住院方面的負擔確實很重。但正如我之前所說,只有 21% 的患者接受了生物製劑治療。

  • And what's interesting is if they do get a biologic, about 65% of them, across biologics, discontinue in the first 12 months. So to me that's very, very attractive for an effective long-acting, two shots a year, which really reduces patient burden. It gives the physician confidence that the patient has coverage. And the shot will be in the U.S., given within the clinic, so the physician has total control of efficacy and that patient.

    有趣的是,如果他們確實服用了生物製劑,大約 65% 的人會在前 12 個月內停藥。所以對我來說,這種有效的長效藥物非常有吸引力,每年註射兩次,確實減輕了患者的負擔。它讓醫生相信病人得到了保障。注射將在美國診所進行,因此醫生可以完全控制療效和患者情況。

  • When we look at market research, it continues to strengthen. I think this is a great test if we ask HDPs in Europe and the U.S. In the U.S., 45% said they'd use it and bio naive immediately. Around 54% in Europe. Again, that's without education, promotion, et cetera. And then 66% of them, in both the US and EU, would consider switching established patients on biologics across to depemokimab.

    當我們進行市場研究時,它繼續增強。如果我們詢問歐洲和美國的 HDP,我認為這是一個很好的測試。在美國,45% 的人表示他們會立即使用它並進行生物純真試驗。歐洲約佔54%。再說一遍,這還不包括教育、升遷等等。其中,美國和歐盟的 66% 的患者會考慮將使用生物製劑的現有患者轉為使用 depemokimab。

  • And then when we look at patients, 6 out of 10 patients say that's clearly easier for them in terms of -- versus every two weeks that they have with Dupilimab right now, going to twice a year. And 9 out of 10 said they'd switch if their doctor recommended it.

    然後,當我們觀察患者時,有 60% 的患者表示,這種方式對他們來說顯然更容易——而現在他們使用 Dupilimab 時每兩週注射一次,需要每年註射兩次。其中 90% 的人表示,如果醫生建議,他們會更換藥物。

  • So I think we've got an evolving very, very competitive product here. We've got established success in severe eosinophilic asthma. The target is well known. The profile is established. So again, I think that one we we should see an encouraging launch in about, yeah, I mean, in terms of the source of patients, we'll get about -- we're targeting about half of them. That's what we want to target initially, is to get naive patients who don't have obviously complicated histories on the product. But again, I think the difference, the other 50%, some will come from Nucala, some will come from other products.

    所以我認為我們已經擁有了一款不斷發展且極具競爭力的產品。我們在治療嚴重嗜酸性氣喘方面已經取得了成功。該目標是眾所周知的。個人資料已建立。所以,我再次認為,我們應該看到一個令人鼓舞的啟動,是的,我的意思是,就患者來源而言,我們將獲得大約 - 我們的目標是其中的一半。這就是我們最初想要的目標,即吸引那些對該產品沒有明顯複雜病史的初次患者。但我再次認為,剩下的 50% 差異,一部分來自 Nucala,一部分來自其他產品。

  • And then finally -- Anything on that one, Tony?

    最後—托尼,對此您有什麼看法嗎?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Still good.

    還不錯。

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Finally, on Blenrep, on track in terms of the July approval date. I mean, the DREAMM-7 data, I think, when we look at marker research, is incredibly compelling. I think one note of caution when you do see other surveys, we're not out there promoting the product yet. So we're limited obviously in what we can do beyond publications and presentations. But clearly, I think that the progression of (inaudible) into the first line opens up a big opportunity for Blenrep in that second line. But some cautions in terms of how we introduce it.

    最後,關於 Blenrep,7 月的批准日期一切順利。我的意思是,當我們研究標記物時,我認為 DREAMM-7 數據非常引人注目。我認為當您看到其他調查時需要注意的是,我們還沒有推廣該產品。因此,除了出版物和演示之外,我們能做的事情顯然是有限的。但顯然,我認為(聽不清楚)進入第一線為 Blenrep 在第二線開闢了一個巨大的機會。但在引入方法上我們需要注意一些事項。

  • Because if you look at the options that they have at second line right now, particularly if you're a community-based heme oncologist who treats 70% of these patients and clearly want to retain these patients in their practice for as long as they can, Blenrep really is a compelling option. They're not really seeing CAR-T as an option in the community because of the complexity of CAR-T. And I think as CAR-Ts evolve, the benefit risk profile continues to become more complex.

    因為如果你看看他們現在在第二線的選擇,特別是如果你是社區血液腫瘤學家,治療 70% 的這些患者,並且顯然希望盡可能長時間地讓這些患者留在他們的診所,那麼 Blenrep 確實是一個引人注目的選擇。由於 CAR-T 的複雜性,他們實際上並沒有將 CAR-T 視為社區中的一種選擇。我認為隨著 CAR-T 的發展,其效益風險狀況將變得更加複雜。

  • If you look at bispecifics, then again, a very rigorous induction process, hospital admissions, complicated dosing, highly frequent dosing, and I think what's increasingly emerging is this infection risk. Which right now, when we look at market research, it seems like community-based heme-oncs are underrepresenting that versus what the data's been published so far. So I think as they start to use those products and get experience with them, that will increase.

    如果你看一下雙特異性抗體,那麼再次強調,這是一個非常嚴格的誘導過程、住院治療、複雜的劑量給藥、高度頻繁的劑量給藥,我認為這種感染風險正在日益顯現。現在,當我們進行市場研究時,似乎以社區為基礎的血液腫瘤學與迄今為止發布的數據相比並沒有得到充分的體現。因此我認為,隨著他們開始使用這些產品並累積經驗,這一比例將會提高。

  • In contrast, with Blenrep, we've got a very, very well-known benefit risk profile with 7,000 patients being exposed. Clearly, we know the focus needs to be on managing the ocular side effects which are reversible. I mean, I think the stats, Tony, if you want to cover that in terms of just how many patients are impacted, how quickly it reverses, and maybe if you want to give some color on that?

    相較之下,對於 Blenrep,我們已經有 7,000 名患者參與了研究,並獲得了非常眾所周知的效益風險狀況。顯然,我們知道重點需要放在控制可逆的眼部副作用。東尼,我的意思是,如果你想從統計數據的角度來說明有多少病人受到影響,病情逆轉的速度有多快,以及你是否想對此進行一些說明?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yeah. Just some data before I get into that. A reminder for everyone that we have a 42% reduction in risk of death from the DREAMM-7 study. That is a projected 33 months of additional life. And then just to quickly cover the numbers on the ocular side effects, they are important. 66% of the individuals on the DREAMM-7 study had no vision changes, 32% had blurred vision but that was for only 11% of the total time on treatment, and only 2% had serious effects which were all reversible.

    是的。在我開始之前先了解一些數據。提醒大家,DREAMM-7 研究顯示死亡風險降低了 42%。預期壽命可延長 33 個月。然後快速介紹一下眼部副作用的數字,它們很重要。 DREAMM-7 研究中,66% 的受試者沒有視力變化,32% 的受試者出現視力模糊,但這僅佔治療總時間的 11%,只有 2% 的受試者出現嚴重影響,但這些影響都是可逆的。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Great.

    偉大的。

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • We're busy.

    我們很忙。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Yeah. So I think at a headline level, James, these are important launches with meaningful data for patients and prescribers. I think we are cautious in terms of materiality of contribution this year. Luke has often described the Blenrep launch as go slow to go very big. And we know that whether it be there or in our ongoing emergence of oncology or indeed in respiratory, these are very material contributors to the next chapter of growth on the '26 and the '26 to '31.

    是的。因此,詹姆斯,我認為從標題層面來說,這些都是重要的發布,為患者和處方者提供了有意義的數據。我認為我們今年對貢獻的重要性持謹慎態度。盧克經常將 Blenrep 的發布描述為「慢慢來,但要取得很大的進展」。我們知道,無論是在那裡,還是在我們不斷湧現的腫瘤學或呼吸系統疾病中,這些都是 2026 年和 2026 年至 2031 年下一階段增長的重要貢獻者。

  • Quickly on tariffs. Look, I'm not going to add a huge amount to what's already been said. First of all, what's in our guidance for this year is obviously the tariffs that's already been announced. But I'd refer you to our press release where we're very specific that in the face of potential sector-specific tariffs, we obviously have been very focused on preparation in a lot of detail and we look carefully at other 232 reviews, we think we have multiple levers. And we see we have multiple levers at our disposal to both navigate and mitigate this.

    迅速討論關稅。瞧,我不會在已經說過的內容上再增加太多內容。首先,我們今年的指導中顯然包含已經宣布的關稅。但我建議您參閱我們的新聞稿,其中我們非常明確地指出,面對潛在的針對特定行業的關稅,我們顯然非常注重細節準備,並且我們仔細研究了其他 232 份評論,我們認為我們有多種手段。我們發現,我們擁有多種手段來應對和緩解這個問題。

  • And the three main ways we think about this are first of all, already through the enormous amount of deliberate work that was done through the separation to create regionally resilient supply chains. It was good to see, as I said, us break ground on the six manufacturing sites. And most of our U.S. products, in some way, touch the U.S. supply chain as well. And we have dual sourcing when we look across other regions.

    我們思考這個問題的三個主要方式是:首先,我們已經透過分離做了大量的刻意工作,以創建具有區域彈性的供應鏈。正如我所說,很高興看到我們在六個生產基地破土動工。而我們大多數的美國產品也以某種方式接觸到美國供應鏈。當我們放眼其他地區時,我們有雙重採購。

  • Obviously, we were delighted secondly with the shift in the gross margin through our deliberate intent on more specialty products. And then thirdly, it's about delivering and accelerating already identified productivity improvements across various areas in the P&L, but we definitely believe we have further opportunity there.

    顯然,我們其次對透過刻意推出更多特色產品而帶來的毛利率變化感到高興。第三,這是為了實現並加速損益表中各個領域已經確定的生產力改進,但我們確實相信我們在那裡還有進一步的機會。

  • So we are prepared. We have a lot of agility and detailed work underpinning this. And we think we can navigate and mitigate in the interests of patients and GSK shareholders, which is why we're confident in our reaffirmation of outlooks.

    所以我們已經做好準備了。我們為此付出了很多敏捷的努力和細緻的工作。我們認為,我們可以為了病人和葛蘭素史克股東的利益進行引導和緩解,這就是我們對重申前景充滿信心的原因。

  • Next question please, I'm hoping we've covered an enormous amount on the launches already which made sure some of the others.

    請問下一個問題,我希望我們已經討論了有關發布的大部分內容,以確保其他一些內容。

  • Constantin Fest - Senior Vice President, Head-Investor Relations

    Constantin Fest - Senior Vice President, Head-Investor Relations

  • Kerry Holford, Berenberg. Please go ahead.

    凱莉·霍爾福德,貝倫貝格。請繼續。

  • Kerry Holford - Analyst

    Kerry Holford - Analyst

  • Thank you very much. A couple for me, please. Firstly on vaccines. I wonder if you can talk to your experience so far with the new U.S. administration, vaccine business, demand. I guess, given the negative rhetoric, are you seeing a negative impact on the demand of your vaccines in the U.S., particularly within the pediatric space?

    非常感謝。請給我幾張。首先是關於疫苗。我想知道您是否可以談談您迄今為止與新美國政府、疫苗業務和需求方面的經驗。我想,考慮到這些負面言論,您是否認為這對美國疫苗的需求產生了負面影響,尤其是在兒科領域?

  • And I'd love to hear your views on whether there is a risk now that RFK, Jr. makes it more difficult to secure future approvals, perhaps here indeed, at some point, a booster for Arexvy in future. So just your feedback and your views on the U.S. vaccines market as it stands today.

    我很想聽聽您的觀點,鑑於羅伯特·肯尼迪 (RFK, Jr.) 使得未來獲得批准變得更加困難,是否存在風險,或許在某種程度上,這確實會成為 Arexvy 未來的助推器。所以這只是您對目前美國疫苗市場的回饋和看法。

  • And then secondly, on Medicare Part D redesign, I think you did reiterate the GBP400 million to GBP500 million headwind for the year and you did say, Julie, that it was within your expectations in Q1. I wonder if you can quantify that. And also, do we expect around half of it still to be centered on HIV? Thank you.

    其次,關於醫療保險 D 部分的重新設計,我認為您確實重申了今年 4 億至 5 億英鎊的逆風,朱莉,您確實說過,這在第一季符合您的預期。我想知道你是否可以量化這一點。此外,我們是否預期其中約一半仍將集中在愛滋病毒上?謝謝。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Yeah. I mean, Julie may add to that. But I would say we are absolutely spot-on on where we thought we would be around the Part D impact and including by product areas on HIV, you're right. Anything else on that?

    是的。我的意思是,朱莉可能會補充這一點。但我想說,我們對 D 部分影響的看法完全正確,包括產品領域對愛滋病毒的影響,您說得對。還有什麼其他資訊嗎?

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • I think it's a good summary, Kerry. We were bang on expectations. HIV is the largest part with GBP150 million to GBP200 million. Specialty is the next one because they tend to be the more expensive medicines. And then the balance is across Vaccines and Gen Med. We've treated it on a straight line basis over the quarters, so the cost of it is evenly spread throughout the year.

    我認為這是一個很好的總結,克里。我們完全符合預期。愛滋病毒是最大的部分,價值 1.5 億至 2 億英鎊。下一個是專科藥物,因為它們往往是更昂貴的藥物。然後平衡點在疫苗和普通醫學之間。我們按照季度直線法進行處理,因此其成本均勻分佈在全年。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Yeah. And on Vaccines, Luke, you may want to add to this, but we gave, as you know, a cautious outlook on the year on Vaccines. We're exactly where we thought we would be at this stage. And remember, with a really challenging comparator versus versus last year on our Vaccines business. None of this takes away from our fundamental confidence in the field and our ambition for the pipeline over the medium term. And we seek to separate between speculation and actual experience. And obviously it's been good to get the approval of Penmenvy away and a double unanimous vote at ACIP, but we have to see where CDC comes out.

    是的。關於疫苗,盧克,你可能想補充一點,但正如你所知,我們對今年的疫苗前景持謹慎態度。我們目前正處於我們預想的階段。請記住,與去年相比,我們的疫苗業務確實面臨挑戰。但這一切都不會動搖我們對該油田的根本信心以及我們對中期管道建設的雄心壯志。我們試圖區分推測和實際經驗。顯然,獲得 Penmenvy 的批准和 ACIP 的雙重一致投票是件好事,但我們必須看看 CDC 的結果。

  • Luke, in terms of what we're seeing in terms of consumer behavior or I mean, pediatrics, you've commented on it actually. It'll be good to hear --

    盧克,就我們所看到的消費者行為或兒科而言,您實際上已經對此發表了評論。很高興聽到--

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Sure. Thanks, Emma. Kerry, I think there's a couple of ways I can cover this. Firstly, the facts are that ACIP has just given the green light to a pediatric vaccine with Penmenvy, so I think that's encouraging. Of course, it needs a signature. But I think that's a good directional sense. If you look at our established vaccines overall, which include a lot of pediatric vaccines like MMRV, they were down a little bit. But that's really due to ASO3 phasing in Canada, Rabipur, and some EU (inaudible), where the MMRV vaccine in the U.S. overall is up 25%. So I think that's also encouraging.

    當然。謝謝,艾瑪。克里,我想有幾種方法可以解決這個問題。首先,事實是 ACIP 剛剛批准了 Penmenvy 兒童疫苗,所以我認為這是令人鼓舞的。當然,需要簽名。但我認為這是一種很好的方向感。如果你看一下我們現有的疫苗總體情況,其中包括許多像 MMRV 這樣的兒科疫苗,它們的數量略有下降。但這其實是由於加拿大、拉比布爾和一些歐盟(聽不清楚)的 ASO3 階段性實施,其中美國的 MMRV 疫苗整體增加了 25%。所以我覺得這也令人鼓舞。

  • If you look more broadly, we do track vaccine hesitancy and attitudes to vaccines. If you look within -- I think, one of the numbers I was looking at the other day is within Arexvy, if someone declines Arexvy, right, it's strongly recommended by physicians, particularly the 75-plus age group. When we look at why does someone decline and not do that, it's only in 17% of the cases that they say they're against the vaccine. So let's see in time. But so far, so good.

    如果從更廣泛的角度來看,我們確實會追蹤人們對疫苗的猶豫和態度。如果你看一下——我想,前幾天我看到的一個數字是在 Arexvy 內部,如果有人拒絕使用 Arexvy,那麼醫生就會強烈推薦它,尤其是 75 歲以上的人群。當我們探討為什麼有人拒絕接種疫苗而不這樣做時,我們發現只有 17% 的人表示他們反對接種疫苗。讓我們拭目以待吧。但到目前為止,一切都很好。

  • I think with Arexvy, the impact is more predating the current administration. It was really ACIP's decision in June of 2024 which, no doubt, we'll get back to later on. So overall, I think, to Emma's point, cautiously optimistic in terms of the direction that we're seeing.

    我認為 Arexvy 的影響遠早於現任政府。這實際上是 ACIP 在 2024 年 6 月做出的​​決定,毫無疑問,我們稍後會回顧這一點。所以總的來說,我認為,正如艾瑪所說,對於我們所看到的方向,我們應該持謹慎樂觀的態度。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • And in terms of your specific question re-vaccinations, as you know, our base case for that is five years. The data that will be presented on that is going to be coming through in 2026. And the earliest, if it's a five-year base case, I mean, let's see, that isn't until 2028. Honestly, I think this will have, the current, if I can say, environmental uncertainty will have settled down pretty clearly by then and obviously, ongoing questions around COVID vaccination aren't pertinent for us. Next question please.

    關於您提到的重新接種疫苗的具體問題,如您所知,我們的基本預期是五年。有關數據將於 2026 年公佈。如果以五年為基準,最早也要到 2028 年。老實說,我認為到那時,當前的環境不確定性將會相當明顯地平息下來,而且顯然,圍繞 COVID 疫苗接種的持續問題與我們無關。請問下一個問題。

  • Constantin Fest - Senior Vice President, Head-Investor Relations

    Constantin Fest - Senior Vice President, Head-Investor Relations

  • Jo Walton, UBS.

    瑞銀的喬沃爾頓。

  • Jo Walton - Analyst

    Jo Walton - Analyst

  • My two questions, I guess, both for Julie. So looking at SG&A, 4%, excluding the base comparison, you've got such a lot of new products to launch, even allowing for the fact that in Respiratory, you've already got people there. As it comes to the antibiotics, as it comes to camlipixant, and et cetera, I wonder if you can just tell us how long you think you can keep that SG&A growth so low and still be utterly confident that you are giving the very best support that's required for those new products coming through.

    我想我的兩個問題都是問朱莉的。因此,看看銷售、一般及行政費用 (SG&A) 4%(不包括基準比較),您就會有很多新產品要推出,即使考慮到在呼吸科,您已經在那裡擁有員工。談到抗生素、談到卡利匹克等等,我想知道您是否可以告訴我們,您認為可以將銷售、一般和行政費用的增長保持在如此低的水平多久,同時仍然完全有信心為這些新產品的推出提供所需的最佳支持。

  • And secondly, and it's sort of tariff-ish related, can you just explain to us or confirm for us that when you ship product around and you ship stuff into the U.S., it's largely at a sort of API-type price, so that any tariffs that were put on would presumably be relatively absorbable? We note that in your annual report you do take quite a big benefit from intellectual property regime elements, and that's presumably an ability to do that in the UK and in particular in Belgium for vaccines. So I think there is some concern that maybe when you ship your vaccines across to the U.S., then maybe they go off at a high price, including some sort of element of royalty, and that would be more difficult to absorb. So it's just the tax, sort of, and just that confirmation as to how you move your stuff around so that we can do our own work on what broader tariffs might mean to your business initially. Thank you.

    其次,這與關稅有關,您能否向我們解釋或確認,當您運送產品到美國時,它基本上是按照 API 類型的價格,因此徵收的任何關稅大概都可以相對吸收?我們注意到,在您的年度報告中,您確實從知識產權制度要素中獲得了相當大的好處,這大概是英國,特別是比利時在疫苗方面能夠做到這一點的能力。因此,我認為有人擔心,當你把疫苗運到美國時,它們可能會以高價出售,其中包括某種版稅,這將更難以承受。所以這只是一種稅收,只是確認你如何運輸你的物品,以便我們可以自己研究更廣泛的關稅最初對你的業務意味著什麼。謝謝。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Okay. Thank you very much, Jo, for the questions. In terms of SG&A, obviously, I'm working very closely with Luke and the team on this, and I'll invite him to comment as well. We feel we've got an opportunity. The areas we're launching products in are the areas where we've got a very strong position already, possibly with the exception of Oncology, which we're still building. But we're very strong, as you know, in Respiratory, you've referred to it already. There's a real synergy we found between Arexvy and Trelegy, as an example, in terms of the launch of Arexvy and the benefit also on Trelegy.

    好的。非常感謝喬提出的問題。在銷售、一般和行政費用方面,顯然我正在與盧克和團隊密切合作,我也會邀請他發表評論。我們覺得我們有機會。我們正在推出產品的領域是我們已經佔據非常強勢地位的領域,可能除了腫瘤學領域,我們仍在建設中。但正如您所知,我們在呼吸系統方面非常強大,您已經提到過這一點。我們發現 Arexvy 和 Trelegy 之間存在真正的協同作用,例如,Arexvy 的推出以及 Trelegy 的受益。

  • So we've worked this through very carefully. We do a multiyear plan, we look at the launches, we look at how we can reallocate resources from the more mature lines, and we use marketing mix models and various other tools to understand the, I guess, the response rates to the marketing investment that we're making and the field force investment we're making. And our basis is driving continued productivity. And you've seen us drive the P&L quite strongly. In terms of the leverage we generated last year, 8 on the top and 13 on the bottom. And the same this year, we continue to do this. So yeah, we're very committed to doing that. Luke, I don't know if you want to add --.

    所以我們非常仔細地處理了這個問題。我們制定了一個多年計劃,我們專注於產品的發布,我們研究如何從更成熟的產品線重新分配資源,我們使用行銷組合模型和各種其他工具來了解我們正在進行的行銷投資和現場力量投資的回應率。我們的基礎是推動持續的生產力。而且您已經看到我們非常強勁地推動了損益表。就我們去年產生的槓桿而言,頂部是8,底部是13。今年我們也將繼續這樣做。是的,我們非常致力於做到這一點。盧克,我不知道你是否想補充--.

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Yeah. I think if we were having this conversation five or six years ago, we'd be talking about a primary care structure, et cetera. Whereas the reality is we've evolved it extensively. And the products I just covered before, these are dramatically more concentrated resourcing events, smaller sales forces, less DTC. So yeah, very confident that we can support these products and evolve it. And that's really our core bread-and-butter day job to do that. And again, as the mix moves to more Specialty dominated, that gets easier, of course, because of the factors that Julie's just outlined.

    是的。我想,如果我們五、六年前進行這個對話,我們會談論初級保健結構等等。而事實上我們已經對其進行了廣泛的改進。而我之前介紹過的產品,這些產品的資源配置活動明顯更集中,銷售團隊規模更小,DTC 更少。所以,是的,我們非常有信心能夠支持這些產品並使其不斷發展。這確實是我們日常的核心工作。而且,隨著產品組合變得更加以專業產品為主,這當然會變得更加容易,這是由於朱莉剛才概述的因素。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Right. And just on tariff, yeah.

    正確的。是的,僅關於關稅。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • On the tariff. In terms of, obviously, the supply chain, our supply chain is inherently complex. We've quite frequently, as Emma mentioned, as a result of the demerger, we've got often dual sourcing. The majority of our products are touching the U.S. in some way through the supply chain --

    關於關稅。就供應鏈而言,顯然我們的供應鏈本質上是複雜的。正如艾瑪提到的那樣,由於公司拆分,我們經常採用雙重採購方式。我們的大部分產品都透過供應鏈以某種方式進入美國--

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Including vaccines.

    包括疫苗。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Including vaccines. Yes, absolutely. And therefore, we wouldn't be in a position of, obviously, when we're calculating the value of the tariff, if it came, it would all be based on the customs value. And therefore, the API is actually not that relevant in terms of the pricing of this. As Emma mentioned at the beginning, we have done a lot of work on this. We've looked at multiple scenarios. We're very confident in our position which really stems from the supply chain dual sourcing and it also stems from the productivity initiatives which are well underway in the company that we're totally committed to delivering.

    包括疫苗。是的,絕對是。因此,顯然,當我們計算關稅價值時,我們不會處於這樣的境地:如果徵收關稅,一切都將基於海關價值。因此,就定價而言,API 實際上並不是那麼重要。正如 Emma 一開始提到的,我們為此做了很多工作。我們研究了多種情景。我們對自己的地位非常有信心,這實際上源於供應鏈的雙重採購,也源於公司正在順利進行的生產力計劃,我們全力致力於實現這些計劃。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Right. Thank you. Next question please.

    正確的。謝謝。請問下一個問題。

  • Constantin Fest - Senior Vice President, Head-Investor Relations

    Constantin Fest - Senior Vice President, Head-Investor Relations

  • Graham Parry, Bank of America.

    美國銀行的格雷厄姆·帕里。

  • Graham Parry - Analyst

    Graham Parry - Analyst

  • Thanks for taking my questions. Just to sort of follow up on that point on tariffs actually. So if you've got productivity initiatives there, what's incremental in those is R&D, for example, a target, and why wouldn't you have just been doing these before? Secondly, just wondered on Shingrix, if you could quantify the sales into China where (inaudible) with inventory. And actually, do you think you could see some sales this year through the course of the remainder of the year?

    感謝您回答我的問題。實際上只是為了跟進關稅問題。因此,如果您有生產力計劃,其中的增量就是研發,例如一個目標,為什麼您以前不這樣做呢?其次,我只是想知道 Shingrix 是否能量化其在中國的銷售情況(聽不清楚)以及庫存情況。實際上,您認為今年剩餘時間內的銷售額能有所成長嗎?

  • And then the last one was just on Arexvy. The 36-month booster data that you showed at ACIP and the ISRSV Conference in Brazil actually showed a lower antibody boost than you saw at the 24-month data. So what gives you the confidence that the vaccine is boostible at all? Because that's sort of staying low and is at the sort of level that saw no incremental efficacy benefit at the second season. Thank you.

    最後一個是在 Arexvy 上。您在 ACIP 和巴西 ISRSV 會議上展示的 36 個月加強數據實際上顯示的抗體增強程度低於您在 24 個月數據中看到的水平。那麼是什麼讓您有信心該疫苗具有加強作用呢?因為這個水平一直保持在低位,並且在第二季中沒有看到任何增量功效的提升。謝謝。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Thanks. I'll come to Tony to talk about [revax] where we still have high confidence that's the most likely scenario. And Luke, you may want a sentence or two on Shingrix. But just to be clear in terms of productivity, of course, this is about our ongoing continuous work to improve the productivity and I would say, primarily, in SG&A where we do have sufficient spending. Luke and Julie have really emphasized, of course, we all know the best way to drive leverage is at the top line and that's going to be through focusing highly efficiently and effectively on our growth-driving products. But there is always opportunity to do more. By the way, technology is advancing all the time to enable us to do more.

    謝謝。我會和托尼談談 [revax],我們仍然非常有信心這是最有可能發生的情況。盧克,你可能想就 Shingrix 說一兩句話。但只是為了明確生產力方面的問題,當然,這是關於我們為提高生產力而不斷進行的工作,我想說,主要是在銷售、一般及行政管理方面,我們確實有足夠的支出。當然,盧克和朱莉確實強調過,我們都知道推動槓桿的最佳方式是在頂線,而這將透過高效和有效地關注我們的成長驅動產品來實現。但總是有機會做得更多。順便說一句,技術一直在進步,使我們能夠做更多的事情。

  • Now there is ongoing work in terms of continuing improving the productivity of R&D. And likewise, we're going as fast as possible. But as Julie said, our first priority is to continue to increase investment behind the acceleration of the pipeline, whether that be the delivery of the current wave or arguably, just as importantly, making sure we set ourselves robustly for ADCs, for the next wave of COPD, for further life cycle innovation, for the accelerated delivery of the BD we're doing which is why we want to use the settlement we've delivered to increase investment in R&D later this year. So we're going at all of it as hard and fast as we can. And we see that as one of the levers to pull as we navigate through potential scenarios which we absolutely do take into account with our modeling forward.

    目前,我們正在持續進行提高研發生產力的工作。同樣,我們也會盡可能地快速前進。但正如朱莉所說,我們的首要任務是繼續增加對加速管道的投資,無論是當前浪潮的交付,還是同樣重要的是,確保我們為 ADC、下一波 COPD、進一步的生命週期創新、加速交付我們正在做的 BD 做好堅實的基礎,這就是為什麼我們希望利用我們已經達成的和解協議在今年晚些時候增加對研發的投資。因此,我們會盡最大努力、盡快完成所有工作。我們認為這是我們在探索潛在情景時需要利用的槓桿之一,我們在未來建模時一定會將其考慮在內。

  • But Tony, do you want to quickly comment on [revax]? And Luke, one sentence or two on China.

    但是托尼,你想快速評論一下[revax]?盧克,請用一兩句話談談中國。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Just a couple of quick points, and Graham, look, as you appreciate, there's no vaccine efficacy (inaudible) established yet. Just to remind everyone, in terms of the three-season vaccine efficacy data that we have in the lower respiratory tract population, we go from 83% efficacy in season one to 48% in season three, so we are seeing waning. The immunogenicity point that you raised is a baseline effect. And if you stratify individuals within that study by their baseline, you'd see a greater boost with lower baseline.

    我只想簡單說幾點,格雷厄姆,正如你所理解的,目前疫苗的有效性(聽不清楚)尚未確定。需要提醒大家的是,就我們在下呼吸道人群中掌握的三個季節的疫苗效力數據而言,第一季的疫苗效力為 83%,而第三季的疫苗效力為 48%,因此我們看到疫苗效力正在減弱。您提出的免疫原性點是基線效應。如果你根據基線對研究中的個體進行分層,你會看到基線較低的人會獲得更大的提升。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Great.

    偉大的。

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Thanks, Graham. On China, look, I've described it as a work in progress. We are making progress, but it takes time. I think we have the right strategic partner. We've reshaped the arrangement. But I think the macro and POV, point of vaccination, dynamics we're watching very closely. But we are seeing encouraging trends. We had around GBP50 million, GBP54 million sales in China in Q1. And we're maintaining a market share of about two-thirds versus (inaudible), which is good, because I think that the one-third of (inaudible) patients are not our target business anyway because of their out-of-pocket sensitivity. So if we have deliveries and we're watching this closely, they'll be for the second half.

    謝謝,格雷厄姆。關於中國,你看,我把它描述為一項正在進行的工作。我們正在取得進展,但這需要時間。我認為我們擁有合適的策略夥伴。我們已經重新制定了安排。但我認為,我們正在密切關注宏觀和 POV、疫苗接種點和動態。但我們看到了令人鼓舞的趨勢。我們第一季在中國的銷售額約為 5,000 萬英鎊至 5,400 萬英鎊。我們保持著約三分之二的市場份額,而(聽不清楚),這很好,因為我認為三分之一的(聽不清楚)患者不是我們的目標業務,因為他們的自付費用很敏感。因此,如果我們有交付並且我們密切關注,它們將出現在下半年。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Yeah. And I think we've been pretty cautious in our outlook for China for this year because of the broader macro as you'd all understand. Next question please.

    是的。我認為,由於更廣泛的宏觀因素,我們對今年中國經濟的展望一直非常謹慎,這大家都明白。請問下一個問題。

  • Constantin Fest - Senior Vice President, Head-Investor Relations

    Constantin Fest - Senior Vice President, Head-Investor Relations

  • Simon Baker, Redburn.

    西蒙貝克,雷德伯恩。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Thank you for taking my questions. Two, if I may please. Firstly on the PrEP market. It was a strong performance by Apretude. Gilead reported strong numbers for Descovy, and they cited broader awareness of prevention and actually cited your promotional activity. So I wonder if you could just give us an update on the dynamics within the PrEP market in terms of switches versus new to prevention.

    感謝您回答我的問題。請問,請給我兩個。首先是 PrEP 市場。Apretude 的表現非常出色。吉利德報告了 Descovy 的強勁數據,他們提到了人們對預防的更廣泛認識,並且實際上引用了你們的促銷活動。所以我想知道您是否可以向我們介紹 PrEP 市場在轉換和預防方面的動態。

  • And related to PrEP and the U.S., is there any impact from the shutdown of USAID on clinical trial recruitment? I was thinking of studies like the PALISADE study which is still showing as ongoing recruiting. And others have suggested that USAID is quite handy in terms of trial, enrollment, and coordination. So any thoughts on that would be helpful.

    關於 PrEP 和美國,美國國際開發署的關閉對臨床試驗招募有何影響?我正在考慮像 PALISADE 這樣的研究,該研究仍然顯示招募仍在進行中。也有人表示,美國國際開發署在試驗、招生和協調方面相當得心應手。因此,對此的任何想法都會有所幫助。

  • And then one for Tony on camlipixant, we've got the CALM-1 study coming up in the second half of this year. I just wonder what a good result looks like there and how relevant is the data that was recently published on the SOOTHE study as a roadmap for the likely outcome of Phase 3 and what constitutes a good result. Thanks so much.

    接著是 Tony 關於 camlipixant 的問題,我們將在今年下半年進行 CALM-1 研究。我只是想知道那裡的好結果是什麼樣的,以及最近在 SOOTHE 研究中發布的數據作為第 3 階段可能結果的路線圖的相關性如何,以及什麼構成了好的結果。非常感謝。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • So David and Tony, please.

    請戴維和托尼發言。

  • David Redfern - President-Corporate Development

    David Redfern - President-Corporate Development

  • Thanks, Simon. On the clinical trial side, I mean, there has been some reduction in funding from the federal government to different investigators and different clinical trial networks. That hasn't specifically affected us. It has had some impact across pediatric studies that have been going on. And obviously, we're working with the community to do what we can there. But there's been no direct impact on GSK or ViiV.

    謝謝,西蒙。在臨床試驗方面,我的意思是,聯邦政府對不同研究人員和不同臨床試驗網絡的資助有所減少。這並沒有對我們造成特別的影響。它對正在進行的兒科研究產生了一定的影響。顯然,我們正在與社區合作,盡我們所能。但這對 GSK 或 ViiV 並沒有直接影響。

  • I think on the PrEP market, I mean through Q1, it's definitely continued the trend. We're very pleased with the performance of Apretude. as I said in my remarks, over 21,000 patients now on Apretude. And we continue to build this market. And we know that, firstly, it is an underdeveloped market. Only a third of Americans that could potentially benefit from PrEP are getting PrEP, so there's a huge market development opportunity. And we recognize, obviously, competition would go up in the second half of the year. But I think that competition could help expand the market.

    我認為在 PrEP 市場上,我的意思是到第一季度,它肯定延續了這一趨勢。我們對 Apretude 的表現非常滿意。正如我在發言中所說,目前有超過 21,000 名患者使用 Apretude。我們將繼續建造這個市場。我們知道,首先,這是一個不發達的市場。只有三分之一的可能從 PrEP 中受益的美國人正在服用 PrEP,因此存在巨大的市場發展機會。我們顯然認識到,下半年競爭將會加劇。但我認為競爭有助於擴大市場。

  • And there's definitely an opportunity to switch more of the oral patients into long-acting because we know that the persistence and therefore the efficacy is much greater. And we were very pleased to have two real-world evidence studies at CROI that I think demonstrated that very clearly in the U.S. and Brazil with the PILLAR and InPrEP studies that showed 100% efficacy, but importantly very strong, long, and persistent.

    而且肯定有機會讓更多口服藥物患者的轉用長效藥物,因為我們知道其持久性和療效會更大。我們非常高興在 CROI 進行了兩項真實世界證據研究,我認為這兩項研究在美國和巴西非常清楚地證明了這一點。 PILLAR 和 InPrEP 研究顯示了 100% 的療效,而且重要的是,它們非常強大、長久且持久。

  • So it's always a work in progress and it's a big change for sexual health clinics and physicians to move from oral PrEP to long-acting PrEP. And there's setup and a whole number of more complex administrative procedures. But progressing well.

    因此,這始終是一項正在進行的工作,對於性健康診所和醫生來說,從口服 PrEP 轉向長效 PrEP 是一個巨大的變化。此外還有設定和一系列更複雜的管理程序。但進展順利。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Right. Tony, on camli.

    正確的。Tony,在 camli 上。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Just on camlipixant and Simon, I'm not going to disclose what we set as the clinically significant baselines for the CALM studies, other than to say that both studies were designed with an objective of showing a clinically significant effect on cough. CALM-1 will read out this year. CALM-2 will read out next year. And of course, we won't be disclosing the broader data across those two studies until we pooled them, as is typical for our Phase 3 studies.

    僅就 camlipixant 和 Simon 而言,我不會透露我們為 CALM 研究設定的臨床顯著基線,只是說這兩項研究的目的都是為了顯示對咳嗽的臨床顯著影響。CALM-1 將於今年讀出。CALM-2 將於明年宣讀。當然,在匯總這兩項研究的數據之前,我們不會透露更廣泛的數據,這是我們第三階段研究的典型做法。

  • Just a quick reminder for everyone about why we're interested in camlipixant. This is a molecule whose selectivity profile is many orders of magnitude in excess of related agents. And Simon, to pick up on that, that is very clearly seen in the SOOTHE study in which the taste disturbance, which has been a challenge for others, was tenfold lower than that for comparator agents. Just a quick reminder about SOOTHE for you. That was a Phase 2 study looking at individuals with 25 coughs per hour. And what we were able to show with camlipixant in that study at both the 50 and 200 mg doses is that a BID regimen achieved a 34% placebo-adjusted reduction in the 24-hour cough frequency.

    只是想快速提醒大家我們為什麼對 camlipixant 感興趣。這種分子的選擇性比相關藥物高出許多個數量級。西蒙,要強調的是,這一點在 SOOTHE 研究中表現得非常明顯,在該研究中,味覺障礙(對其他人來說是一個挑戰)比對照藥物低了十倍。只是想快速提醒您一下有關 SOOTHE 的資訊。這是一項第二階段研究,研究對象為每小時咳嗽 25 次的個體。在該研究中,我們能夠證明,50 毫克和 200 毫克劑量的 camlipixant 的 BID 方案使 24 小時咳嗽頻率在安慰劑調整後減少了 34%。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Great. Thank you. A couple more.

    偉大的。謝謝。還有幾個。

  • Constantin Fest - Senior Vice President, Head-Investor Relations

    Constantin Fest - Senior Vice President, Head-Investor Relations

  • Rajan Sharma, Goldman Sachs.

    高盛的拉詹·夏爾馬。

  • Rajan Sharma - Analyst

    Rajan Sharma - Analyst

  • Hi. Thanks for taking my question. Just a couple left, actually, just ahead of the Blenrep PDUFA, have you had any interactions with the agency on the potential REMS requirement? And if not, could you potentially just talk to your base case assumption for REMS and how potential scenarios here could influence uptake? And then secondly, just one on capital allocation priorities. Just given that valuations are significantly lower than perhaps a year or so ago, is there a potential for you to be more active on the BD front? Or is the macro backdrop likely to be a limiting factor? Thanks.

    你好。感謝您回答我的問題。實際上,只剩下幾個了,就在 Blenrep PDUFA 之前,您是否與該機構就潛在的 REMS 要求進行過任何互動?如果沒有,您能否談談您對 REMS 的基本情況假設以及這裡的潛在情景如何影響吸收?其次,僅討論資本配置優先事項。鑑於估值比一年前低得多,您是否有可能在 BD 方面更加活躍?或者宏觀背景可能是個限制因素?謝謝。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Yeah. Very quickly, you're absolutely right, our appetite for BD remains high. And we think there may be some opportunities in this environment. Obviously, we have to be cautious about assumptions on the macro. But that's a question of discipline and returns. But we continue to be busy reviewing and connecting. So that's still definitely a priority for us.

    是的。很快,你完全正確,我們對 BD 的興趣仍然很高。我們認為這種環境下可能存在一些機會。顯然,我們必須對宏觀假設保持謹慎。但這是一個紀律和回報的問題。但我們仍然忙於審查和聯繫。所以這對我們來說仍然是優先事項。

  • On the sort of scale and pace of what you've us doing, we're pleased to get IDRx away, but certainly a key priority in capital allocation going forward.

    就我們所做工作的規模和速度而言,我們很高興能夠擺脫 IDRx,但這無疑是未來資本配置的首要任務。

  • Luke, I wonder whether -- well, actually, let's go to Tony first, just in terms of FDA and we're not going to get ahead of ourselves on that, considering, it's not very far away, but on your comments on REMS. And Luke, maybe you could just say very briefly how you see that in terms of uptake, because I know it's something that you really want to invest the time in getting right.

    盧克,我想知道——好吧,實際上,我們先來談談托尼,就 FDA 而言,考慮到距離不是很遠,我們不會超越自己,但關於你對 REMS 的評論。盧克,也許你可以非常簡要地談談你對這個問題的接受程度的看法,因為我知道這是你真正想投入時間去做好的事情。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yeah. And I might just bridge that to Luke with the UK approval that we've got. And obviously, our regulatory interactions are confidential, so I'm not going to get into the details of those. But it's probably worthwhile stressing, as I'm sure you're aware, the REMS are not uncommon for new oncology medicines. You have, for example, for Herceptin, then the need for cardiac scans; for Enhertu, the management of interstitial lung disease; and doxorubicin, cardiomyopathy. So within that, I think it's useful to take a look at the UK approval which requires eye examination for each of the first four doses associated with Blenrep. I'll let Luke speak to that and the opportunity for us to set up then relationships with high street providers to complete that. I won't repeat what I said earlier, but the important point is really an understanding of the data in terms of efficacy and resolution of side effects and their severity in the ocular events.

    是的。我可能會利用我們已獲得的英國批准將此事轉達給盧克。顯然,我們的監管互動是保密的,所以我不會談論其中的細節。但可能值得強調的是,我相信您已經意識到,REMS 對於新的腫瘤藥物來說並不罕見。例如,對於赫賽汀,需要進行心臟掃描;對於 Enhertu,用於治療間質性肺病;和阿黴素、心肌病變。因此,我認為有必要了解英國的批准,該批准要求對 Blenrep 的前四劑進行眼科檢查。我會讓盧克談論這一點,以及我們與商業街供應商建立關係以完成這一目標的機會。我不會重複我之前說過的話,但重要的一點是真正了解數據的功效和副作用的解決方案以及它們在眼部事件中的嚴重程度。

  • Luke Miels - Chief Commercial Officer

    Luke Miels - Chief Commercial Officer

  • Thanks, Tony. REMS are obviously something that's familiar to heme oncologists. There's a number of agents used in multiple myeloma that have REMS. I won't break down our assumptions on various REMS designs. But I think common sense would say that the less burdensome and more supportive versus the more complicated. But we're spending a lot of time, and let's go back to my earlier point, which is, it's really about supporting the physician. We understand a lot more about the dosing of this product and dose holes, et cetera. So the behavior of the product and how the ocular dimension can be managed through dose holes and really accessing that overall survival is an important component.

    謝謝,托尼。REMS 顯然是血液腫瘤學家所熟悉的。有多種藥物可用於治療具有 REMS 的多發性骨髓瘤。我不會破壞我們對各種 REMS 設計的假設。但我認為,常識告訴我們,負擔越輕、越支持越多,就越複雜。但是我們花了大量的時間,讓我們回到我之前的觀點,那就是,這實際上是為了支持醫生。我們對該產品的劑量、劑量孔等有了更多的了解。因此,產品的行為以及如何透過劑量孔管理眼部尺寸並真正評估整體存活率是一個重要組成部分。

  • We're also spending a lot of time on the nuts and bolts of how the patients go through the system. How do you make it as easy as possible for heme oncologists when they've got that patient in front of them, who's just progressed on daratumumab, how do you make it as easy as possible that they can put their practice machinery in place in a community setting, to get that patient onto Blenrep.

    我們也花費了大量時間研究患者如何透過該系統的具體細節。當血液腫瘤學家面對一位剛在服用達雷妥尤單抗後病情出現進展的患者時,您如何讓他們能夠盡可能輕鬆地在社區環境中部署他們的實踐機制,讓該患者使用 Blenrep。

  • We've also looked at a lot of things like collaborations with optometry groups. We know that 90% of patients in the U.S. or potential patients in the U.S. with multiple myeloma live within half an hour of an eyecare professional, which is not surprising, because most of them, obviously, the older need some form of glasses like probably a lot of people on this call. So again we're being very thoughtful about how we navigate that. And I think that's all we can say at this point beyond what Tony has covered with the UK.

    我們也研究了很多事情,例如與驗光團體的合作。我們知道,90% 的美國多發性骨髓瘤患者或潛在患者居住在距離眼科保健專業人員不到半小時的路程內,這並不奇怪,因為他們中的大多數,顯然是老年人,需要某種形式的眼鏡,就像這次通話中的許多人一樣。因此,我們再次認真考慮如何解決這個問題。我想,除了托尼已經談到的英國問題之外,我們現在能說的就這些了。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Brilliant. Thanks for the reference to our aging profile. Time for one more last question, I think, Constantin.

    傑出的。感謝您參考我們的老化概況。康斯坦丁,我想是時候再問最後一個問題了。

  • Constantin Fest - Senior Vice President, Head-Investor Relations

    Constantin Fest - Senior Vice President, Head-Investor Relations

  • Sarita Kapila, Morgan Stanley.

    薩里塔·卡皮拉,摩根士丹利。

  • Sarita Kapila - Analyst

    Sarita Kapila - Analyst

  • Hi. Thanks for taking my questions. Just a quick one from me on your long-term HIV strategy. Do you have any plans to develop longer-acting orals as we've seen from some of your competitors? And if these long-acting orals are successful, how do you see that impacting your competitive positioning given the double-down on injectable pipeline? Thank you.

    你好。感謝您回答我的問題。我只想簡單介紹一下你們的長期愛滋病戰略。正如我們從一些競爭對手那裡看到的那樣,您是否有計劃開發長效口服藥物?如果這些長效口服藥物成功,考慮到注射劑產品線的雙倍投入,您認為這會對您的競爭地位產生什麼影響?謝謝。

  • David Redfern - President-Corporate Development

    David Redfern - President-Corporate Development

  • Thanks for the question. I think we are primarily focused on generating longer-acting injectables. Very pleased with both the progress with Cabenuva which, obviously, is the first mover in long-acting injectable treatment and great to see the growing momentum there both in the U.S. and Europe. And we are focused around taking that forward with both four-month options and then potentially longer options, six-month and so forth. I'm very excited with the data we presented at CROI on VH184 which really showed rapid and very potent antiviral activity and very importantly, a very broad resistance profile. We'll have more to say on that next year. But I think we're getting increasingly excited about VH184 as being a significant potential medicine.

    謝謝你的提問。我認為我們主要致力於生產長效注射劑。我對 Cabenuva 的進展感到非常高興,它顯然是長效注射治療領域的先驅,並且很高興看到它在美國和歐洲都呈現出成長勢頭。我們致力於推進這一進程,首先推出四個月的選擇,然後可能推出更長的選擇,例如六個月等等。我對我們在 CROI 上展示的 VH184 數據感到非常興奮,它確實顯示出快速且非常有效的抗病毒活性,而且非常重要的是,它具有非常廣泛的抗藥性。明年我們會對此進行更多討論。但我認為我們對 VH184 作為一種重要的潛在藥物越來越感到興奮。

  • In terms of the weekly orals and so forth, I mean, we're obviously monitoring that. I think they will likely largely cannibalized daily orals. And we'll have to see how that goes. There's different views and different levels of market research on patient preference and compliance and so forth. But our focus at this point is really building on the first-mover long-acting treatment advantage we have. And we see very clear patient preference to go there.

    就每週的口頭報告等而言,我的意思是,我們顯然正在監控這一點。我認為他們可能會在很大程度上蠶食每日口服藥。我們將拭目以待事情進展如何。對於患者偏好和依從性等問題,有不同的觀點和不同層次的市場研究。但我們目前的重點其實是鞏固我們擁有的先發長效治療優勢。我們非常清楚地看到患者傾向於去那裡。

  • Dame Emma Walmsley - Chief Executive Officer, Executive Director

    Dame Emma Walmsley - Chief Executive Officer, Executive Director

  • Great. Thanks, David. And thank you, everyone, for joining the call. We are only at Q1. But it's great to have a strong start for GSK. We're very much on track to deliver our 2025 outlooks, despite the weather, with strong growth in our biggest business in Specialty Medicines and of course, most importantly, really exciting continued pipeline progress. So we look forward to catching up with you in the coming days and months. And thanks for joining the call.

    偉大的。謝謝,大衛。感謝大家參加此次電話會議。我們目前僅處於第一季。但對葛蘭素史克來說,有一個好的開始是件好事。儘管天氣不佳,但我們仍有望實現 2025 年的願景,我們最大的特種藥品業務將實現強勁增長,當然,最重要的是,令人興奮的管道持續進展。因此,我們期待在未來的日子和月份與您保持聯繫。感謝您參加電話會議。