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Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Ladies and gentlemen, a very warm welcome to the GSK Q2 2025 results call. I'm delighted to be joined today by Emma Walmsley, Tony Wood, Luke Miels, Deborah Waterhouse, and Julie Brown, with David Redfern joining for Q&A.
女士們、先生們,熱烈歡迎大家參加葛蘭素史克 2025 年第二季業績電話會議。我很高興今天能與 Emma Walmsley、Tony Wood、Luke Miels、Deborah Waterhouse 和 Julie Brown 一起參加,David Redfern 也參與了問答環節。
Today's call will last approximately one hour, with the presentation taking around 30 minutes and the remaining time for your questions. Please ask only one or two questions so that everyone has a chance to participate. 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.
今天的電話會議將持續約一個小時,其中演示大約需要 30 分鐘,其餘時間用於回答您的問題。請只問一兩個問題,讓每個人都有機會參與。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(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。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Thank you, and welcome to everybody joining us today. Please turn to the next slide. Our second-quarter results once again demonstrate GSK's strong performance momentum and the quality and strength of our portfolio. Group sales were up 6% for the quarter. Core operating profit was up 12%, and core earnings per share grew 15% to 46.5p.
謝謝大家,歡迎大家今天加入我們。請翻到下一張投影片。我們第二季的業績再次證明了葛蘭素史克強勁的業績勢頭以及我們產品組合的品質和實力。本季集團銷售額成長了 6%。核心營業利潤成長 12%,核心每股收益成長 15%,至 46.5 便士。
Sales growth was driven by our largest business, Specialty Medicines, up 15%. And vaccine sales also contributed with sales up 9% in the quarter. This led to increases in profits and earnings, which also benefited from a strong focus on SG&A. Alongside operating performance, we continue to make good progress in R&D, with three FDA approvals achieved so far this year.
銷售額的成長主要得益於我們最大的業務——特種藥品,成長了 15%。疫苗銷售也做出了貢獻,本季銷售額成長了 9%。這導致利潤和收益增加,同時也得益於對銷售、一般和行政費用的高度關注。除了營運表現外,我們在研發方面也持續取得良好進展,今年迄今已獲得三項 FDA 批准。
Cash generation also remains very positive with GBP3.7 billion generated in the first half to support further investments in growth and returns to shareholders. The dividend for the quarter was 16p, and we've now completed more than GBP800 million of the share buyback program initiated in February. All of this is underscored by our commitment to operating as a responsible business, our most recent action being to expand our voluntary license agreement with the Medicines Patent Pool to now include long-acting cabotegravir for treatment of HIV as well as prevention.
現金產生也保持非常積極的狀態,上半年產生了37億英鎊,以支持進一步的成長投資和股東回報。本季的股息為 16 便士,我們目前已完成 2 月啟動的超過 8 億英鎊的股票回購計畫。所有這些都突顯了我們作為一家負責任的企業開展營運的承諾,我們最近的行動是擴大與藥品專利池的自願許可協議,現在將用於治療和預防愛滋病毒的長效卡博特韋納入其中。
And finally, driven by our strong performance, we're confirming today that we now expect to be towards the top end of the financial guidance given for 2025. Next slide, please.
最後,在強勁業績的推動下,我們今天確認,我們預計將達到 2025 年財務指引的最高水準。請看下一張投影片。
Following the demerger of Helion, we made a commitment to drive a step change in performance at GSK. This quarter has again shown that GSK is delivering consistent sales growth, operating leverage, and positive financial performance. The investments and development choices we made in our portfolio, notably to launch new Specialty Medicines have really helped to drive these new performance levels. In the last three years, we've launched innovations in respiratory, immunology, oncology, and HIV, and we have a lot more to come.
在 Helion 拆分之後,我們承諾推動 GSK 績效的顯著改善。本季再次表明葛蘭素史克正在實現持續的銷售成長、經營槓桿和積極的財務表現。我們在投資組合中所做的投資和開發選擇,特別是推出新的特殊藥物,確實有助於推動這些新的績效水準。在過去三年中,我們在呼吸系統、免疫學、腫瘤學和愛滋病毒領域取得了創新,我們還將取得更多進展。
Alongside our new vaccine to prevent meningitis and an antibiotic to treat urinary tract infections, three of the five product approvals we expect this year are Specialty Medicines. Tony will talk to each of them in more detail shortly.
除了預防腦膜炎的新疫苗和治療泌尿道感染的抗生素外,我們今年預計批准的五種產品中,有三種是特殊藥物。托尼很快就會與他們每個人進行更詳細的交談。
But let me touch just briefly on Blenrep. As you'll have seen, the FDA has extended the review period for Blenrep with a new target action date of October 23. We remain very confident that Blenrep can bring significant benefit to patients with multiple myeloma in the US and are in constructive discussions with the agency. Meanwhile, we continue to receive approvals and prepare for launches of Blenrep in many other countries, including across Europe, Japan, Canada, the UK, and Switzerland.
但請容許我簡單談談 Blenrep。正如您所看到的,FDA 已延長 Blenrep 的審查期,新的目標行動日期為 10 月 23 日。我們仍然非常有信心,Blenrep 可以為美國多發性骨髓瘤患者帶來顯著益處,並且正在與該機構進行建設性的討論。同時,我們繼續獲得批准並準備在許多其他國家推出 Blenrep,包括歐洲、日本、加拿大、英國和瑞士。
So with the portfolio we have and the launches to come, we expect Specialty to be a major driver of growth for GSK. Our Specialty business accounts for around 40% of sales today, and we expect this to be well over 50% by 2031. Next slide, please.
因此,憑藉我們現有的產品組合和即將推出的產品,我們預計專業產品將成為葛蘭素史克成長的主要動力。目前,我們的專業業務約佔銷售額的 40%,我們預計到 2031 年將遠超過 50%。請看下一張投影片。
As we've consistently said and demonstrated, our number one priority for capital allocation is to invest for growth. We're doing this by focusing strongly on the delivery of the 14 scale opportunities we've previously highlighted, all of them with peak year sales above GBP2 billion. By ensuring we have appropriate resources for priority launches and by prioritizing capital in R&D to our I&I and oncology, both organically and with targeted business development. Our BD has real momentum and is a key driver of pipeline expansion.
正如我們一貫所說和所證明的那樣,我們資本配置的首要任務是投資於成長。我們透過大力關注先前強調的 14 個規模機會來實現這一目標,這些機會的年銷售額高峰均超過 20 億英鎊。透過確保我們擁有適當的資源用於優先推出的產品,並優先將研發資金投入到我們的I&I和腫瘤學領域,既有有機投入,也有針對性的業務發展。我們的 BD 擁有真正的發展勢頭,是管道擴張的關鍵驅動力。
We'll be adding four high potential assets to late-stage development this year. And three starting Phase III was sourced through disciplined BD, IBRx, efimosfermin, and our ADC targeting B7-H3. And we'll also begin a pivotal trial to support our four monthly long-acting injectable regimen for HIV treatment.
今年我們將在後期開發中增加四項高潛力資產。三個起始 III 期臨床試驗是透過嚴格的 BD、IBRx、efimosfermin 和針對 B7-H3 的 ADC 獲得的。我們也將開始一項關鍵試驗,以支持我們為期四個月的長效愛滋病毒注射治療方案。
And we continue to add high-value innovation at earlier stages of development, too. The pioneering strategic collaboration announced with Hengrui this week is another excellent example of this. Lastly and very importantly, we continue to optimize our supply chain with significant investment in US manufacturing and scaling up of capacity for our new modalities and technology platforms. And as we said last quarter, our overall planned investment in the USA is in the tens of billions of dollars over the next five years. Next slide, please.
而我們也在開發的早期階段持續增加高價值創新。本週與恆瑞宣布的開創性策略合作就是另一個很好的例子。最後,也是非常重要的一點,我們將繼續優化我們的供應鏈,對美國製造業進行大量投資,並擴大我們新模式和技術平台的產能。正如我們上個季度所說,未來五年我們在美國的總計畫投資將達到數百億美元。請看下一張投影片。
With the breadth of our current business and the growth opportunities we have in our pipeline, we are highly confident in our outlook for sales of more than GBP40 billion by 2031. And as we've repeatedly demonstrated with our pipeline development, this long-term outlook has consistently improved, and we are ambitious and committed to do more. Next slide, please.
憑藉我們目前業務的廣度和我們擁有的成長機會,我們對 2031 年銷售額超過 400 億英鎊的前景充滿信心。正如我們在管道開發中反覆證明的那樣,這種長期前景一直在不斷改善,我們雄心勃勃,致力於做得更多。請看下一張投影片。
So overall, with the momentum we have, the progress we're making, we're very confident we can deliver the targets we've set for growth in the short, medium, and longer term.
總的來說,憑藉我們現有的勢頭和取得的進展,我們非常有信心能夠實現我們設定的短期、中期和長期成長目標。
Let me now hand over to Tony to talk to you in more depth about our great R&D progress. Next slide, please.
現在,我請 Tony 來更深入地向您介紹我們偉大的研發進展。請看下一張投影片。
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
Thank you, Emma. Next slide, please. Our number one priority in R&D is to develop transformational specialty medicines and vaccines in areas of high unmet need that positively impact health and deliver significant growth. This is evident in the 14 scale opportunities we have for launch before 2031 and in the progress we're making to expand and accelerate our early-stage pipeline of first and best-in-class assets.
謝謝你,艾瑪。請看下一張投影片。我們在研發方面的首要任務是在尚未滿足的大量需求領域開發具有變革性的特殊藥物和疫苗,以對健康產生積極影響並帶來顯著增長。這體現在我們在 2031 年之前推出的 14 個規模機會以及我們在擴大和加速我們早期的一流資產管道方面所取得的進展。
We remain focused on four core therapy areas enabled by advanced technologies, talents, and a network of world-class partnerships. And we continue to deepen our expertise in the science of the immune system. This is most recently exemplified with our work to develop IL-5 medicines for lung diseases, which is providing us with a better understanding of the role of the immune system in fibro inflammation, leading us to target diseases beyond the lung towards kidney, liver, and with the potential future application in neuroimmunology. Next slide, please.
我們將繼續專注於四個核心治療領域,並依靠先進的技術、優秀的人才和世界一流的合作夥伴網絡。我們將繼續深化對免疫系統科學的專業知識。我們最近致力於開發用於治療肺部疾病的 IL-5 藥物,這讓我們更了解免疫系統在纖維發炎中的作用,使我們能夠針對肺部以外的疾病,例如腎臟、肝臟,並有可能在未來應用於神經免疫學。請看下一張投影片。
Based on decades of research, we have a unique understanding of the role that inflammation plays in chronic airway disease, our focus on the underlying biology of inflammation, notably in COPD, has led to a differentiated pipeline of long-acting options, each strongly supported by human genetics, disease phenotyping, and insights from our own scale clinical trials.
基於數十年的研究,我們對發炎在慢性呼吸道疾病中的作用有了獨特的理解,我們專注於發炎(尤其是 COPD)的潛在生物學,從而產生了差異化的長效治療方案,每種方案都得到人類遺傳學、疾病表型和我們自己規模的臨床試驗的見解的有力支持。
In May, we received FDA approval for Nucala for the treatment of COPD. This is the fifth indication for Nucala in the US. We've also filed depemokimab, our novel opting IL-5 antagonist for the treatment of asthma and chronic rhinosinusitis with nasal polyps with regulators. And we have a PDUFA date of 16 December.
五月,我們獲得了 FDA 批准使用 Nucala 治療 COPD。這是 Nucala 在美國獲得的第五個適應症。我們也提交了 depemokimab 申請,這是我們的新型選擇性 IL-5 拮抗劑,用於治療氣喘和伴隨鼻息肉的慢性鼻竇炎及調節劑。我們的 PDUFA 日期是 12 月 16 日。
I'm also pleased to report for the first time today positive results from the AGILE continuation study, which further underscore the sustained efficacy and safety over a two-year period of twice yearly depemokimab. AGILE is an open-label 12-month extension study in severe asthma patients who completed either SWIFT-1 or SWIFT-2. The results show that patients who continue to receive depemokimab maintain the efficacy achieved in the prior trials. Importantly, patients who crossed over from placebo also saw reduction in exacerbation rates consistent with results in SWIFT. As a reminder, the SWIFT studies demonstrated a 72% reduction in exacerbations requiring hospitalization for patients who received depe.
我也很高興今天首次報告 AGILE 延續研究的積極成果,這進一步強調了每年兩次的 depemokimab 在兩年內的持續療效和安全性。AGILE 是一項針對完成 SWIFT-1 或 SWIFT-2 的嚴重氣喘患者進行的開放標籤 12 個月延伸研究。結果顯示,繼續接受depemokimab治療的患者能夠維持先前試驗中所取得的療效。重要的是,從安慰劑轉為安慰劑的患者的病情惡化率也降低了,這與 SWIFT 的結果一致。提醒一下,SWIFT 研究表明,接受 Depe 治療的患者需要住院治療的病情惡化率降低了 72%。
I'm also pleased to confirm today that we started an extensive development program for depe as an add-on treatment in COPD. The ENDURE trials are now recruiting. And the VIGILANT trial designed to evaluate efficacy in earlier-stage disease is planned to start later this year.
今天,我還很高興地確認,我們已經啟動了一項廣泛的開發計劃,將 depe 作為 COPD 的附加治療方法。ENDURE 試驗目前正在招募參與者。旨在評估早期疾病療效的 VIGILANT 試驗計劃於今年稍後啟動。
As the only company with a range of ultra-long-acting mechanisms, specifically IL-5, IL-33, and TSLP, we're competitively in place to lead in this disease. And through our license agreement with Hengrui, we're now adding a novel potential best-in-class PDE3/4 inhibitor, addressing gaps in the treatment of patients who face continued (inaudible) or who are unlikely to receive inhaled corticosteroids or biologics because of their disease profile. Last but not least, the camlipixant CALM-1 and CALM-2 trials remain on track and will be reported together in 2026. Next slide, please.
作為唯一一家擁有一系列超長效機制(特別是 IL-5、IL-33 和 TSLP)的公司,我們在該疾病領域具有領先優勢。透過與恆瑞達成的許可協議,我們現在增加了一種新型的潛在最佳 PDE3/4 抑制劑,解決了那些因疾病狀況而面臨持續(聽不清楚)或不太可能接受吸入皮質類固醇或生物製劑治療的患者在治療中的空白。最後但同樣重要的一點是,camlipixant CALM-1 和 CALM-2 試驗仍在進行中,並將於 2026 年一起報告。請看下一張投影片。
In immunology, we're extending our expertise in inflammation to understand how it leads to fibrosis in the lung, liver, and kidneys treat to treat, prevent, and stop disease progression. Fibrotic diseases are thought to account 45% of all deaths worldwide. So there's a major unmet need here. These conditions are typically seen as difficult to treat. But our work in human genetics and phenotype being combined with emerging platform technologies, including oligonucleotides, which have a unique ability to modulate gene expression in the liver, is showing real promise.
在免疫學方面,我們正在擴展我們在發炎方面的專業知識,以了解它如何導致肺、肝和腎的纖維化,從而治療、預防和阻止疾病進展。據估計,纖維化疾病佔全球死亡人數的 45%。因此,這裡存在著一個尚未滿足的重大需求。這些病症通常被認為難以治療。但是,我們在人類遺傳學和表型方面的工作與新興平台技術(包括具有調節肝臟基因表現的獨特能力的寡核苷酸)相結合,正在顯示出真正的前景。
As a result, we now have a growing hepatology pipeline with assets to treat chronic hepatitis B as well as steatotic liver disease, or SLD, starting in metabolic dysfunction associated to steatohepatitis or MASH and alcohol-associated liver disease, or ALD.
因此,我們現在擁有不斷增長的肝病學產品線,包括治療慢性乙型肝炎以及脂肪變性肝病(SLD)的資產,從與脂肪性肝炎或 MASH 和酒精性肝病(ALD)相關的代謝功能障礙開始。
Let's start with hepatitis B, a considerable market opportunity with a large unmet need and limited standard of care with bepirovirsen and oligonucleotide. We have an exciting opportunity for a functional cure. Promising data from the Phase II B-Clear and B-Sure studies demonstrate a sustained loss of hep B surface antigen below the level of quantification. Importantly, new insights from recent epidemiological studies have shown that loss of surface antigen reduces all-cause mortality by up to 62% and the risk of developing liver cancer by up to 89% in HBV patients. We expect to present additional follow-up data from B-Sure at AASLD later this year. Our Phase IIIb well trial continues at pace with data expected in the first half of 2026.
讓我們從乙肝開始吧,這是一個巨大的市場機遇,存在大量未滿足的需求,而且貝匹羅韋生和寡核苷酸的治療標準有限。我們有一個令人興奮的功能性治療機會。第二階段 B-Clear 和 B-Sure 研究的有希望的數據表明乙肝表面抗原持續丟失至定量水平以下。重要的是,最近的流行病學研究的新見解表明,表面抗原的喪失可使B型肝炎患者的全因死亡率降低高達 62%,罹患肝癌的風險降低高達 89%。我們預計將於今年稍晚在 AASLD 上展示 B-Sure 的更多後續數據。我們的 IIIb 階段井試驗正在按計劃進行,預計將於 2026 年上半年獲得數據。
I'm also delighted to share that the United Phase II study has completed recruitment four months ahead of schedule. This trial is looking at sequential administration of daplasirin and tomligisiran followed by bepi, which will read out in 2027. If positive, it will significantly expand the patient population who could benefit from treatment. As already highlighted, we're also excited to complete the acquisition of efimosfermin or efi. This adds another Phase III-ready potential best-in-class medicine to our pipeline.
我也很高興地告訴大家,聯合二期研究已經提前四個月完成了招募。此次試驗研究的是達普拉西林和托利吉西蘭的順序給藥,然後是貝伐單抗,結果將於 2027 年公佈。如果結果呈陽性,這將大大擴大可從治療中受益的患者群體。正如已經強調的那樣,我們也很高興完成對 efimosfermin 或 efi 的收購。這為我們的產品線增添了另一種已準備好進入 III 期且具有潛力的最佳藥物。
Efi is a once-monthly FGF21 analog with Phase II data, which demonstrated its potential to reverse liver fibrosis in MASH. We plan to start Phase III trials in MASH later this year with plans for further development in ALD. And of course, development of GSK'990, our siRNA therapeutic continues for other success of patients with SLD. We see these two assets as complementary, providing options to develop both monotherapies and combinations.
Efi 是一種每月一次的 FGF21 類似物,具有 II 期數據,證明了其逆轉 MASH 肝纖維化的潛力。我們計劃於今年稍後開始 MASH 的 III 期試驗,並計劃在 ALD 方面進行進一步開發。當然,我們仍在繼續開發 GSK'990,即我們的 siRNA 療法,以幫助其他 SLD 患者取得成功。我們認為這兩種資產是互補的,為開發單一療法和組合療法提供了選擇。
Let's turn to oncology now. Next slide, please. Here, our momentum continues, and we're rapidly expanding beyond our current focus in hematological and gynecological cancers to treat additional solid tumors. On Blenrep, as Emma has said, the new PDUFA date is October 23, 2025, providing the FDA with time to review additional information provided in support of the application. We're in constructive discussions with the FDA.
現在讓我們來談談腫瘤學。請看下一張投影片。在這裡,我們的發展勢頭持續不斷,我們正在迅速擴大目前對血液學和婦科癌症的關注範圍,以治療更多的實體腫瘤。關於 Blenrep,正如 Emma 所說,新的 PDUFA 日期是 2025 年 10 月 23 日,這為 FDA 提供了時間來審查為支持該申請而提供的其他資訊。我們正在與 FDA 進行建設性的討論。
And while I know you'll want more details, the review process remains confidential, and so I'll update you when we can. Outside the US, we've already received regulatory approvals from Europe, Japan, Canada, the UK, and Switzerland, all pointing to the positive impact this medicine can have for patients with multiple myeloma.
雖然我知道您想了解更多詳細信息,但審核過程仍是保密的,因此我會盡快向您通報最新情況。除了美國外,我們已經獲得歐洲、日本、加拿大、英國和瑞士的監管部門批准,這些批准都表明這種藥物會對多發性骨髓瘤患者產生積極影響。
Elsewhere in the portfolio, we are progressing multiple development programs. Last year, Jemperli was expanded to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit in these indications. Initial results from the ALS1 trial in rectal cancer are expected in 2026, with the Phase III JADE study in locally advanced head and neck cancer also ongoing.
在投資組合的其他部分,我們正在推進多個開發項目。去年,Jemperli 的治療範圍擴大到所有患有原發性晚期或復發性子宮內膜癌的成年患者,成為第一個也是唯一一個在這些適應症中顯示出總體生存益處的基於免疫腫瘤學的治療方法。直腸癌 ALS1 試驗的初步結果預計將於 2026 年公佈,局部晚期頭頸癌的 III 期 JADE 研究也在進行中。
For Ojjaara, studies are underway to expand the label into MDS and additional indications are also in planning. We have a high ambition for our new ADC portfolio. And given the significant potential we see here, we're prioritizing investment. We are developing GSK'227, our B7-H3 ADC in lung cancer and evaluating other solid tumors. We've already received two breakthrough designations from the FDA in relapsed or refractory extensive stage small cell lung cancer and in late-line relapsed or refractory osteosarcoma.
對於 Ojjaara,正在進行研究以將標籤擴展到 MDS,並且還在計劃增加其他適應症。我們對新的 ADC 產品組合抱有很高的期望。鑑於我們看到的巨大潛力,我們優先考慮投資。我們正在開發 GSK'227,這是我們用於治療肺癌的 B7-H3 ADC,並正在評估其他實體腫瘤。我們已經獲得了 FDA 頒發的兩項針對復發或難治性廣泛期小細胞肺癌和晚期復發或難治性骨肉瘤的突破性治療資格。
Early combination data with PD-L1 indicates the potential for a chemo-free regimen in first-line small cell lung cancer with more mature data expected in November. And we're on track to start a pivotal study before the end of the year. For GSK'584, our B7-H4 ADC will start pivotal studies early next year.
與 PD-L1 的早期聯合數據表明,一線小細胞肺癌有無需化療方案的潛力,預計 11 月將有更成熟的數據。我們計劃在今年年底前開始一項關鍵研究。對於 GSK'584,我們的 B7-H4 ADC 將於明年初開始關鍵研究。
Lastly, earlier this year, we entered into an agreement to acquire IDRX-42, a highly selective KIT inhibitor being developed as a first and second line therapy for treatment of gastrointestinal stromal tumors or GIST. IDRX-42, now GSK'981, has demonstrated activity against all key primary and secondary KIT mutations observed in GIST. This breadth of coverage in addition to high selectivity, which could provide improved tolerability, offers a potential best-in-class profile. We'll start recruitment for pivotal study in second line before year-end. Next slide, please.
最後,今年早些時候,我們達成協議收購 IDRX-42,這是一種高選擇性 KIT 抑制劑,正在開發作為治療胃腸道間質瘤或 GIST 的一線和二線療法。IDRX-42(現為 GSK'981)已證明可對抗 GIST 中觀察到的所有關鍵原發性和繼發性 KIT 突變。這種覆蓋範圍廣、選擇性高,可以提高耐受性,從而提供潛在的最佳同類產品。我們將在年底前開始招募二線關鍵研究的人員。請看下一張投影片。
Within infectious diseases, we're developing prevention and treatment options with broad coverage. Two of our recent FDA approvals exemplify this. Penmenvy, our pentavalent meningococcal vaccine, offers more strained coverage, enabling higher protection from the serious consequences of infection to more teens and young adults. And Blujepa is the first new class of antibiotic in over 30 years for the treatment of uncomplicated UTIs, a condition that affects 50% all women.
在傳染病領域,我們正在開發涵蓋廣泛的預防和治療方案。我們最近獲得的兩項 FDA 批准就證明了這一點。我們的五價腦膜炎雙球菌疫苗 Penmenvy 提供更嚴格的覆蓋,為更多青少年和年輕人提供更高的保護,使他們免受感染的嚴重後果。Blujepa 是 30 多年來首個用於治療無併發症泌尿道感染的新型抗生素,50% 的女性患有這種疾病。
We're also making progress with other ID assets. Our Phase III trial for tebipenem and treatment of complicated UTIs was stopped early for efficacy. Arexvy received a positive ACIP recommendation, expanding issues to adults aged 50 to 59. And the Shingrix, we're now researching this vaccine's potential for use beyond shingles.
我們在其他身分資產方面也取得了進展。我們針對替比培南治療複雜性泌尿道感染的 III 期試驗因療效不佳而提早停止。Arexvy 獲得了 ACIP 的積極推薦,其適用範圍擴大到 50 至 59 歲的成年人。對於 Shingrix,我們目前正在研究這種疫苗在帶狀皰疹以外的治療用途的潛力。
Given the increasing number of real-world evidence studies showing a potential protective effect in dementia, we've initiated several research collaborations to explore this effect prospectively. These include a first-of-its-kind large-scale linkage study with the UK Dementia Research Institute and Health Data Research UK. Of course, development work in HIV is also a clear priority, and you'll hear more from Deborah on this shortly. Next slide, please.
鑑於越來越多的現實世界證據研究表明其對癡呆症具有潛在的保護作用,我們已啟動多項研究合作,以前瞻性地探索這種作用。其中包括與英國癡呆症研究所和英國健康資料研究中心進行的首次大規模連結研究。當然,愛滋病毒防治工作的發展也是一項明確的優先事項,您很快就會聽到黛博拉對此進行更詳細的介紹。請看下一張投影片。
I'm pleased with the strong momentum and material progress we're making in R&D. I believe we have more and better opportunities with 66 assets in full clinical development, 16 currently in late stage, and 8 regulatory breakthrough designations already this year. Our deepening expertise in immunology, use of advanced technologies, and world-class partnerships are delivering results. We've had three FDA approvals so far this year and remain on track for two more.
我對我們在研發方面取得的強勁勢頭和實質進展感到高興。我相信,我們有更多更好的機會,今年已有 66 項資產處於全面臨床開發階段,16 項資產處於後期階段,並且已有 8 項監管突破稱號。我們在免疫學領域不斷深化的專業知識、先進技術的運用以及世界一流的合作關係正在取得成果。今年到目前為止,我們已經獲得了三項 FDA 批准,並且有望獲得另外兩項批准。
Adding to a record 13 positive Phase III readouts in 2024, we expect another 15 readouts through 2025 and 2026. And for the remainder of this year, we'll start pivotal studies for four assets. Two of these are in oncology with our B7-H3 ADC in extensive stage small cell lung cancer and IDRX-42 in second line GIST. In hepatology, we'll start efimosfermin in MASH, and in HIV, a pivotal study for our Q4M ultra-long-acting treatment regimen.
加上 2024 年創紀錄的 13 個 III 期陽性讀數,我們預計到 2025 年和 2026 年還會有 15 個讀數。今年剩餘時間,我們將針對四項資產展開關鍵研究。其中兩種是腫瘤學藥物,我們的 B7-H3 ADC 用於治療廣泛期小細胞肺癌,IDRX-42 用於治療二線 GIST。在肝病學領域,我們將在 MASH 中啟動 efimosfermin 研究,並在 HIV 中啟動 Q4M 超長效治療方案的關鍵研究。
Overall, we have a clear path to extend our leadership in respiratory, exciting new prospects in immunology and inflammation, and momentum in oncology alongside major pipeline opportunities to come in infectious disease and HIV. Next slide, please.
總體而言,我們有明確的途徑來擴大我們在呼吸領域的領導地位,在免疫學和發炎領域擁有令人興奮的新前景,在腫瘤學領域擁有發展勢頭,同時在傳染病和愛滋病毒領域也擁有重大的研發機會。請看下一張投影片。
To finish, I'll go back to where I started with our focus on the best-in-class pipeline in areas of huge unmet need, which you can see here and where we're making an important difference to the health of billions of people.
最後,我將回到我一開始提到的重點,即我們專注於在巨大未滿足需求的領域中打造一流的產品線,您可以在這裡看到,我們正在為數十億人的健康做出重要貢獻。
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, Tony. Please turn to the next slide. In Q2, we delivered GBP8 billion in sales, up 6% versus last year, demonstrating strong execution and demand-driven growth. Growth in the quarter was driven by Specialty Medicines, up 15% and strong Shingrix and meningitis demand in Europe, with some offset driven by the expected impact of the Medicare Part D redesign across the portfolio, which is tracking as expected. Next slide, please.
謝謝,托尼。請翻到下一張投影片。第二季度,我們的銷售額達到 80 億英鎊,比去年增長 6%,體現了強大的執行力和需求驅動的成長。本季的成長主要得益於特種藥物的推動,其成長了 15%,並且歐洲對 Shingrix 和腦膜炎藥物的需求強勁,但部分抵消了醫療保險 D 部分對整個產品組合重新設計的預期影響,而該產品組合的進展符合預期。請看下一張投影片。
Specialty Medicines continues to be the most important of our diversified business with double-digit growth once again in all therapy areas. Starting with RII, sales were up 10%, even with the expected tough comparators for Nucala and Benlysta, and this was driven by strong demand. Benlysta, our treatment for lupus, grew 13% and is now positioned as a preferred therapy in all global guidelines. And in the quarter, (inaudible) also updated their recommendation for use of Benlysta up to three years following remission.
特種藥物繼續成為我們多元化業務中最重要的部分,所有治療領域再次實現兩位數成長。從 RII 開始,銷售額就成長了 10%,儘管 Nucala 和 Benlysta 的競爭對手預計會比較激烈,但這是由強勁的需求推動的。我們的狼瘡治療藥物 Benlysta 成長了 13%,目前已被全球所有指引列為首選治療方法。並且在本季度,(聽不清楚) 也更新了對緩解後長達三年使用 Benlysta 的建議。
And Nucala, our anti-IL-5 biologic grew 7%, in line with expectations following an inventory build in quarter two of 2024 and the impact of Medicare Part D redesign, both offset by a strong performance in Europe and international. We are very pleased with the label we have in COPD, which I'll cover in a minute.
我們的抗 IL-5 生物製劑 Nucala 成長了 7%,符合 2024 年第二季庫存增加和醫療保險 D 部分重新設計的影響後的預期,但歐洲和國際市場的強勁表現抵消了這一增長。我們對 COPD 中的標籤感到非常滿意,我稍後會介紹它。
Moving to our growing oncology portfolio, which was up 42%. Jemperli for endometrial cancer continues to see increasing patient demand and growing market share in both dMMR and MMRp populations following our all-comers approval in the US and Europe, up 91% in the quarter. And Ojjaara sales were up 69%, driven by strong US volume growth, including growing demand from moderate anemic patients that represents 65% of the market opportunity.
我們不斷成長的腫瘤學產品組合成長了 42%。繼美國和歐洲全面批准用於治療子宮內膜癌的 Jemperli 藥物後,患者需求持續增加,dMMR 和 MMRp 人群的市場份額也不斷增長,本季度增長了 91%。Ojjaara 的銷售額成長了 69%,這得益於美國銷售的強勁成長,其中包括中度貧血患者不斷增長的需求,這佔了市場機會的 65%。
And Blenrep had its first sales in second-line multiple myeloma following early launch days in the UK, and more on that in a minute. With this strong momentum and the great performance from ViiV that Deborah will cover, we are increasing our full-year specialty guidance, now expected to grow in the low teens percentage. Next slide, please.
Blenrep 在英國上市後不久便在二線治療多發性骨髓瘤的領域取得了首次銷售,稍後我們將詳細介紹。憑藉這一強勁勢頭以及 Deborah 將要介紹的 ViiV 的出色表現,我們正在提高全年專業指導,目前預計增長率將達到百分之十幾。請看下一張投影片。
In respiratory, we're very pleased with the strong label we received from Nucala as COPD. We now have an important opportunity to reach a wide spectrum of patients with our blood esinophil count starting at 150 cells per microliter, a key differentiator for our monthly biology. The label also includes important data showing a 35% reduction in hospitalizations from severe exacerbations, a high-quality data point as we know that one in two patients hospitalized from COPD will die within five years and that these hospitalizations are responsible for 70% of all COPD-related costs.
在呼吸系統疾病方面,我們對 Nucala 授予的 COPD 強有力標籤感到非常高興。現在,我們有一個重要的機會可以接觸到廣泛的患者,我們的血液嗜酸性粒細胞計數從每微升 150 個細胞開始,這是我們每月生物學的關鍵區別因素。該標籤還包含重要數據,顯示因嚴重惡化而住院的人數減少了 35%,這是一個高品質的數據點,因為我們知道,因 COPD 住院的患者中有一半會在五年內死亡,而這些住院費用佔所有 COPD 相關費用的 70%。
We continue to look forward to the significant opportunity we have with depemokimab, our twice-yearly IL-5, which has been far that all major markets for approval in severe asthma and nasal polyps. Both opportunities we expect will expand the market for biologics in this space. We've also had very positive market research, which shows 86% of pulmonologists. I think depe could become standard of care. And 87% of patients said that they would be likely to use depe if supported by HCP, and we look forward to a US FDA decision toward the end of the year.
我們繼續期待 depemokimab(我們的一年兩次的 IL-5)帶來的重大機遇,該藥物已在所有主要市場獲得批准,用於治療嚴重氣喘和鼻息肉。我們預計這兩個機會都將擴大該領域的生物製劑市場。我們也進行了非常積極的市場調查,結果顯示 86% 的肺病專家都表示同意。我認為 depe 可以成為護理標準。87% 的患者表示,如果得到 HCP 的支持,他們可能會使用 depe,我們期待美國 FDA 在年底前做出決定。
On Blenrep, we're very confident in the opportunity for this important medicine and continue to emphasize the projected overall survival benefit of 33 months compared to standard of care from DREAMM-7. Our premium coordination of care service has already been well received in the UK, following approval and launch in April. We're also pleased to have received approval in Europe, Japan, Canada, the UK, and Switzerland. And as you have heard from both Emma and Tony, we're continuing to work with the FDA to bring this important medicine to American patients.
對於 Blenrep,我們對這種重要藥物的機會非常有信心,並繼續強調與 DREAMM-7 的標準治療相比,其預計的總體生存期為 33 個月。我們的優質護理協調服務自四月獲得批准並推出以來,已在英國獲得廣泛好評。我們也很高興獲得歐洲、日本、加拿大、英國和瑞士的批准。正如艾瑪和東尼所說,我們將繼續與 FDA 合作,將這種重要藥物帶給美國患者。
I'll now hand over to Deborah to cover HIV.
現在我將把愛滋病毒問題交給黛博拉。
Deborah Waterhouse - Chief Executive Officer, ViiV Healthcare and President - GSK Global Health
Deborah Waterhouse - Chief Executive Officer, ViiV Healthcare and President - GSK Global Health
Thank you, Luke. Our HIV portfolio continues to deliver exceptional growth of 12% in the quarter. 9 points of growth came from strong patient demand for our long-acting injectables and Dovato, and 3 points came from customer stocking patterns and tender phasing. We saw demand grow across all regions and major markets, particularly the US, which grew 14% through double-digit demand growth and where we saw not only total share gain outpacing the competition, but Cabenuva consistently gaining at least 70% of product switches from competitors.
謝謝你,盧克。我們的 HIV 產品組合在本季繼續實現 12% 的出色成長。 9 個百分點的成長來自患者對我們的長效注射劑和 Dovato 的強勁需求,3 個百分點的成長來自客戶的備貨模式和招標階段。我們看到所有地區和主要市場的需求都在增長,尤其是美國,其需求增長了 14%,達到了兩位數,我們不僅看到總份額的增長超過了競爭對手,而且 Cabenuva 的產品轉換率持續從競爭對手那裡獲得了至少 70%。
Dovato continued to deliver strong performance, up 23%. And our long-acting injectables, Cabenuva and Apretude, delivered robust growth at 46% and 50%, respectively. With treatment accounting for 90% of the total GBP22 billion HIV market, we continue to drive the shift to longer injectables.
Dovato 繼續表現強勁,上漲 23%。我們的長效注射劑 Cabenuva 和 Apretude 分別實現了 46% 和 50% 的強勁成長。治療佔愛滋病毒總市場(價值 220 億英鎊)的 90%,我們將繼續推動長效注射劑的轉變。
In Q2, Cabenuva and Apretude delivered more than 70% of our total growth driven by the US, where they now account for one-third of sales. Focusing on long-acting injectables for treatment, strong patient preference is reinforced by VOLITION, a Phase IIIb study shared at the IAS conference this month, showing nearly 90% of newly diagnosed people chose to switch to Cabenuva from daily pills after achieving viral suppression. This medicine continues to transform the lives of more than 90,000 people living with HIV. Apretude saw strong growth in the quarter, and we expect it to continue to grow in H2 in the US, bolstered by over three years of real-world data, demonstrating more than 99% effectiveness along with excellent safety and tolerability across broad populations. We have set a high bar for tolerability with Apretude, given by one shot intramuscularly.
在第二季度,Cabenuva 和 Apretude 貢獻了我們總成長的 70% 以上,這主要得益於美國市場,目前它們在美國的銷售額佔比達到三分之一。該藥物專注於長效注射劑治療,本月在 IAS 會議上分享的一項 IIIb 期研究 VOLITION 強化了患者的強烈偏好,該研究顯示,近 90% 的新診斷患者在達到病毒抑制後選擇從每日服用的藥片改用 Cabenuva。這種藥物正在持續改變9萬多名愛滋病毒感染者的生活。Apretude 在本季度實現了強勁增長,我們預計它在美國下半年將繼續增長,這得益於三年多的真實世界數據,證明了其有效性超過 99%,並且在廣大人群中具有出色的安全性和耐受性。我們對 Apretude 的耐受性設定了很高的標準,透過一次肌肉注射給藥。
This quarter, we initiated the Phase I CLARITY study in healthy volunteers to evaluate the tolerability of a competitor long-acting injectable against Apretude robust profile. We are very optimistic about the outcome and look forward to sharing data at an autumn conference. Given our strong and sustained performance today, we are adjusting our 2025 HIV guidance upwards to mid- to high single-digit percentage growth. Next slide, please.
本季度,我們在健康志願者中啟動了第一階段 CLARITY 研究,以評估競爭對手長效注射劑與 Apretude 強效特性的耐受性。我們對結果非常樂觀,並期待在秋季會議上分享數據。鑑於我們目前強勁而持續的表現,我們將 2025 年愛滋病毒指引上調至中高個位數百分比成長。請看下一張投影片。
We continue to progress our industry-leading pipeline with integrated inhibitors at the core and have multiple long-acting options with strong profiles for Q4M, Q6M, and self-administered. Building on our established three-monthly injectable regimens, we believe four-monthly dosing in PrEP and treatment will be important options, delivering longer dosing intervals and ensuring continuity of care. Our Q4M PrEP trial has recruited rapidly and is going well. The FDA have asked for an extra four months of data, which means the study will read out in H2 2026, and we look forward to launching in H1 2027.
我們繼續推進以綜合抑制劑為核心的產業領先產品線,並擁有多種長效選擇,具有強大的 Q4M、Q6M 和自我管理特性。在我們已建立的每三個月注射一次的方案的基礎上,我們相信每四個月進行一次 PrEP 和治療將是重要的選擇,可以提供更長的給藥間隔並確保護理的連續性。我們的 Q4M PrEP 試驗招募工作進展順利。FDA 要求提供額外四個月的數據,這意味著該研究將在 2026 年下半年完成,我們期待在 2027 年上半年啟動。
At the launch of Q4M treatment, we expect to have the only complete long-acting injectable treatment regimens on the market for many years to come. Looking ahead to our twice yearly injectables, we're on track to confirm the dosing regimen for Q6M treatment in 2026 and expect to file and launch both Q6M for treatments and PrEP between 2028 and 2030.
在推出 Q4M 治療方案時,我們期望在未來許多年內擁有市場上唯一完整的長效注射治療方案。展望我們每年兩次的注射劑,我們預計在 2026 年確認 Q6M 治療的給藥方案,並預計在 2028 年至 2030 年期間提交並推出用於治療和 PrEP 的 Q6M。
For treatment, we are particularly excited about VH184, our third-generation INSTI, which has the best resistance profile seen to date and has the potential to be the backbone of our next generation of HIV treatment regimens with IP cover through at least the end of the next decade.
對於治療,我們對我們的第三代 INSTI VH184 特別感興趣,它具有迄今為止最好的抗藥性特徵,並且有可能成為我們下一代 HIV 治療方案的支柱,至少在下一個十年末實現 IP 覆蓋。
We also continue to pursue potential cures for HIV. In July, we initiated ENTRANCE, a first time in-human study, featuring bNAb N6LS with or without fostemsavir, currently marketed as Rukobia. This work is at an early stage, and we are pleased to bring our scientific expertise to this notoriously difficult area.
我們仍在繼續尋找愛滋病毒的潛在治療方法。7 月,我們啟動了 ENTRANCE,這是一項首次人體研究,研究對象為 bNAb N6LS 聯合或不聯合 fostemsavir,目前以 Rukobia 的名稱銷售。這項工作尚處於早期階段,我們很高興將我們的科學專業知識帶到這個眾所周知的困難領域。
With a 10-year head start in long-acting treatment, we are focusing on the next generation of HIV innovation. We remain confident that our pipeline, including five planned launches by 2030, will continue to drive performance over the coming decade and beyond.
我們在長效治療領域領先 10 年,目前專注於下一代 HIV 創新。我們堅信,我們的產品線(包括計劃於 2030 年推出的五款產品)將在未來十年及以後繼續推動業績成長。
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, Deborah. Turning to Vaccines. Sales for Q2 were GBP2.1 billion, up 9%, primarily driven by strong demand in Europe for Shingrix and our meningitis vaccines. Shingrix sales grew 6% in total, as our global expansion strategy is delivering with 72% of our sales now coming from outside the US. Growth was driven by launches and national immunization approvals in countries like France and Japan, and we remain confident in the ex US opportunity.
謝謝,黛博拉。轉向疫苗。第二季的銷售額為 21 億英鎊,成長 9%,主要得益於歐洲對 Shingrix 和我們的腦膜炎疫苗的強勁需求。Shingrix 的銷售額整體成長了 6%,因為我們的全球擴張策略正在取得成效,目前 72% 的銷售額來自美國以外。成長是由法國和日本等國家的上市和國家免疫批准推動的,我們對美國以外的機會仍然充滿信心。
Starting in Europe, Shingrix sales were up 48%, led by swift uptake in France and strong demand across several countries, including Spain, the Netherlands, Italy, and Greece. In the US, penetration is now 42% of the eligible older adult population, achieved in about half the time it took for older adult pneumococcal vaccines. And with harder-to-reach patients, the immunization rates have slowed as expected. And in international, accelerated uptake in Japan following expanded public funding in April was offset by a tough Q2 2024 comparator, which included supply to our co-promotion partner in China and a rapid uptake in Australia.
從歐洲開始,Shingrix 的銷售額成長了 48%,這主要得益於法國的快速普及以及西班牙、荷蘭、義大利和希臘等多個國家的強勁需求。在美國,目前符合資格的老年人口的接種率已達到 42%,只用了老年人肺炎球菌疫苗接種所需時間的一半左右。對於難以接觸到的患者,免疫接種率正如預期的那樣放緩。在國際上,日本在 4 月份公共資金增加後加速了增長,但這一增長被 2024 年第二季度的艱難比較所抵消,其中包括向我們在中國的聯合推廣夥伴供應產品以及在澳大利亞的快速增長。
In meningitis, our portfolio was up 22%, with strong double-digit growth across Europe and international, driven primarily by Bexsero, the only MenB indicative for infants. In the US, where we have dominant leadership in the MenB adolescent market, we're excited to introduce our pentavalent vaccine Penmenvy. We expect this vaccine to simplify immunization schedules and contribute to increasing coverage and protection against serious life-threatening illness.
在腦膜炎方面,我們的投資組合成長了 22%,在歐洲和國際範圍內實現了強勁的兩位數成長,主要得益於唯一針對嬰兒的 MenB 藥物 Bexsero。在美國,我們在 MenB 青少年市場佔據主導地位,我們很高興推出我們的五聯疫苗 Penmenvy。我們希望這種疫苗能夠簡化免疫接種計劃,並有助於提高對嚴重危及生命的疾病的覆蓋率和保護率。
Turning to Arexvy. Obviously, we are preseason, but Arexvy sales increased 13%, maintaining market leadership in the US older adult segment and benefiting from strong uptake in Germany. In the US, we're also pleased to see that earlier this month, the CDC confirmed the ACIP recommendation for adults aged 50 to 59 at increased risk. In the current vaccines environment, we continue to expect this market will take time to build. But with our strong clinical profile in the most vulnerable populations, we remain confident long-term in the importance of this vaccine.
轉向 Arexvy。顯然,我們正處於季前階段,但 Arexvy 的銷售額成長了 13%,保持了美國老年人市場的領先地位,並受益於德國的強勁成長。在美國,我們也很高興看到,本月早些時候,美國疾病管制與預防中心確認了美國預防接種計劃 (ACIP) 對 50 至 59 歲高風險成年人的建議。在目前的疫苗環境下,我們仍然預期這個市場的建立需要時間。但鑑於我們在最脆弱人群中擁有強大的臨床表現,我們仍然對這種疫苗的長期重要性充滿信心。
And finally, our broad portfolio of established vaccines grew 6%, primarily due to favorable CDC stockpile movements for Infanrix, Pediarix in the US.
最後,我們廣泛的成熟疫苗組合成長了 6%,這主要得益於美國疾病管制與預防中心 (CDC) 對 Infanrix 和 Pediarix 的有利儲備。
Overall, our vaccines business is performing well amidst a challenging external environment. And driven by the good half one performance, we are increasing our outlook for vaccine sales today to decline low single digit to stable, and we remain confident in the medium- and long-term prospects of this business and pipeline. Next slide, please.
總體而言,儘管外部環境充滿挑戰,我們的疫苗業務表現良好。在上半年良好表現的推動下,我們上調了疫苗銷售額預期,預計銷售額將從目前的個位數低位下降至穩定,並且我們對該業務和產品線的中長期前景仍然充滿信心。請看下一張投影片。
Turning to General Medicines, which was down 6% as expected, following a very tough comparative for Trelegy in Q2 of last year. As you may remember, Trelegy was up 41% in Q2 '24, due in large part to significant adjustments in returns and rebates. This quarter, Trelegy grew 1% in the US and 4% globally despite the tough comp and pricing headwinds from the Medicare Part D redesign. Trelegy is now in its eighth year on the market and we are continuing to see all-time high shares with room to grow.
談到通用藥物,該股如預期下跌 6%,而去年第二季 Trelegy 的業績非常艱難。您可能還記得,Trelegy 在 2024 年第二季上漲了 41%,這在很大程度上歸功於回報和回扣的重大調整。本季度,儘管醫療保險 D 部分重新設計帶來了嚴峻的競爭和定價阻力,但 Trelegy 在美國仍增長了 1%,在全球增長了 4%。Trelegy 現已進入上市第八年,我們看到其股價繼續創下歷史新高,並且還有成長空間。
Beyond Trelegy, the rest of the General Medicines portfolio was down, reflecting continued generic competition across the portfolio and adjustments in rebates and returns as expected. We continue to expect sales to be broadly stable in 2025 and look forward to the opportunity we have in adding anti-infectives into this part of the business, with the approval of Blujepa for uncomplicated urinary tract infections in the US, which we will launch later this year. We have also seen progress on tebipenem, as Tony highlighted, an important oral option to keep complicated urinary tract infection patients out of hospital.
除 Trelegy 外,其餘通用藥物組合均出現下滑,反映出整個組合中仿製藥的持續競爭以及回扣和回報的預期調整。我們繼續預計 2025 年的銷售額將基本保持穩定,並期待有機會將抗感染藥物添加到這一業務領域,因為 Blujepa 已在美國獲得批准用於治療無併發症的泌尿道感染,我們將於今年稍後推出該產品。正如托尼所強調的那樣,我們也看到了替比培南的進展,這是一種重要的口服藥物,可以讓複雜性泌尿道感染患者免於住院。
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 continues to build momentum in 2025, with sales increasing 6%, driven by continued strong Specialty performance, complemented by growth in Vaccines. Cost of sales for the quarter grew 7% ahead of sales due to pricing impacts and supply chain optimization charges.
謝謝你,盧克,大家下午好。請看下一張投影片。首先以 CER 表示的季度損益表作為開始。2025 年,葛蘭素史克 (GSK) 將繼續保持強勁發展勢頭,銷售額將增長 6%,這得益於專科業務持續強勁的表現以及疫苗業務的增長。由於定價影響和供應鏈優化費用,本季銷售成本比銷售額成長 7%。
Core operating profit grew 12%, with strong leverage in the quarter, delivered through a 1% reduction in SG&A, demonstrating our disciplined returns-based approach, and a 70% increase in royalties due to the upfront receipt from the IP settlement announced in April. Core EPS grew 15%, continuing to demonstrate our track record of delivering margin leverage and enhanced by lower interest charges as well as the share buyback.
核心營業利潤成長 12%,本季槓桿率強勁,這得益於銷售、一般及行政費用 (SG&A) 減少 1%,體現了我們嚴謹的基於回報的方法,而由於 4 月份宣布的 IP 結算預收款,特許權使用費增加了 70%。核心每股收益成長了 15%,繼續證明了我們提供保證金槓桿的良好記錄,並因較低的利息費用以及股票回購而得到增強。
Turning to total results. Growth of 33% was largely driven by a favorable ViiV CCL movement, predominantly due to currency, partially offset by intangible asset impairments. Next slide, please.
轉向整體結果。33% 的成長主要得益於 ViiV CCL 的有利變動,這主要歸因於貨幣,但無形資產減損部分抵銷了這一成長。請看下一張投影片。
This chart illustrates the margin improvement year on year. The operating margin improved in the quarter by 180 basis points, driven by SG&A and royalties. Whilst we continue to invest competitively behind product launches, SG&A improved the margin by 190 bps due to phasing between the quarters and accelerated productivity improvements. As I mentioned, royalties were driven by the RSV IP settlement, the income from which is being reinvested in R&D this year, with priority projects accelerating this quarter.
此圖表顯示了利潤率的逐年提高。受銷售、一般及行政費用和特許權使用費的推動,本季營業利潤率提高了 180 個基點。雖然我們繼續在產品發布後進行有競爭力的投資,但由於季度之間的分階段和生產力提高的加速,銷售、一般和行政費用的利潤率提高了 190 個基點。正如我所提到的,特許權使用費是由 RSV IP 結算推動的,該結算的收入今年將被重新投資於研發,本季優先項目的進展將加快。
Finally, whilst the portfolio and margin continued to benefit from the transition towards Specialty, the Q2 fall in the gross margin was predominantly driven by lower RAR benefits year on year and by charges associated with supply chain optimization. Next slide, please.
最後,雖然產品組合和利潤率繼續受益於向專業化轉型,但第二季毛利率的下降主要是由於 RAR 收益同比下降以及與供應鏈優化相關的費用。請看下一張投影片。
Turning to the cash flow with commentary before the one-off impact of Zantac payments. Cash generated from operations were GBP3.9 billion at the half, improving by more than GBP1 billion, and demonstrating our continued focus on cash discipline as we remain on track for more than GBP10 billion CGFO in 2026. The improvement year to date is driven by increased operating profit and favorable movements in RAR, partially offset by increased working capital, driven by higher Arexvy and Shingrix collections last year. Free cash flow improved by GBP1.3 billion, driven by strong CGFO and the favorable phasing of tax payments.
在 Zantac 付款的一次性影響之前,轉向現金流並進行評論。上半年經營活動產生的現金為 39 億英鎊,增加了 10 多億英鎊,顯示我們繼續注重現金紀律,我們預計在 2026 年實現超過 100 億英鎊的 CGFO。今年迄今的改善是由營業利潤的成長和 RAR 的有利變動所推動的,但部分被去年 Arexvy 和 Shingrix 收款增加所推動的營運資本的增加所抵消。受強勁的總財務利潤 (CGFO) 和有利的納稅分階段政策的推動,自由現金流增加了 13 億英鎊。
Zantac payments so far this year have totaled GBP124 million, and we expect the remaining GBP1.1 billion to be paid through the second half. Next slide, please. Turning to capital allocation. We continue to deploy cash in a disciplined manner and underpinned by a strong balance sheet in line with our framework. Our net debt to core EBITDA remains broadly aligned with this time last year. Our priority is always to invest for growth, evidenced by the increasing investment in R&D, together with the ongoing BD.
今年迄今為止,Zantac 的付款總額已達到 1.24 億英鎊,我們預計剩餘的 11 億英鎊將在下半年支付。請看下一張投影片。轉向資本配置。我們將繼續以嚴謹的方式部署現金,並以符合我們框架的強勁資產負債表為基礎。我們的淨債務與核心 EBITDA 比率與去年同期基本持平。我們的首要任務始終是投資成長,這可以從我們不斷增加的研發投資以及持續的業務拓展中看出。
In the first half, we had outflows relating to a number of deals, including the acquisition of IDRX, and we will continue to look for opportunities, particularly in Specialty, consistent with the size and frequency of recent deals. We have also made over GBP2 billion in shareholder distributions in the first half through the dividend and share buyback program, which is progressing at pace, with more than GBP800 million executed so far and with a total of GBP1.3 billion expected to be completed by the end of the year.
上半年,我們發生了與多筆交易相關的資金流出,包括收購 IDRX,我們將繼續尋找機會,特別是在專業領域,與近期交易的規模和頻率保持一致。我們也透過股利和股票回購計畫在上半年向股東分配了超過 20 億英鎊,該計畫正在快速推進,迄今已執行超過 8 億英鎊,預計到年底將完成總計 13 億英鎊。
Please note, in the second half, net debt is expected to include almost GBP3 billion of outflows relating to the settlement of Zantac, the completion of efimosfermin, and the Hengrui collaboration, together with the ongoing share buyback. Next slide, please.
請注意,下半年,淨債務預計將包括與 Zantac 結算、efimosfermin 完成、恆瑞合作以及正在進行的股票回購相關的近 30 億英鎊的資金流出。請看下一張投影片。
GSK's momentum continues to build, and we are pleased with the performance this year. We now expect to deliver towards the top end of our guidance ranges on sales operating profit and EPS, and we are adjusting our full year guidance for Specialty, HIV, and Vaccines upwards. Regarding our 2025 P&L guidance, in line with our capital allocation priorities, we expect gross margin to benefit from product mix for the full year. We are accelerating investments in the pipeline and now expect R&D to grow ahead of sales.
葛蘭素史克的勢頭持續增強,我們對今年的表現感到滿意。我們現在預計銷售額、營業利潤和每股盈餘將達到指導範圍的最高值,並且我們正在上調專科、愛滋病毒和疫苗的全年指引。關於我們的 2025 年損益指引,根據我們的資本配置優先事項,我們預計全年毛利率將受益於產品組合。我們正在加快對現有項目的投資,目前預計研發成長將超過銷售成長。
We also remain committed to a low single-digit percentage growth in SG&A for the full year. Whilst there will be a step-up in investment in Q3 behind our upcoming launches, we will also see an acceleration of SG&A productivity initiatives with the associated charges and benefits in the remainder of the year.
我們也將繼續致力於實現全年銷售、一般及行政費用 (SG&A) 的低個位數百分比成長。雖然我們即將在第三季加大對即將推出的產品的投資,但在今年剩餘時間內,我們還將看到銷售、一般及行政費用 (SG&A) 生產力計劃的加速以及相關費用和收益的增加。
And finally, net interest expense is now expected to be lower than previously guided at GBP550 million to GBP600 million due to the later phasing of Zantac payments. Our guidance is inclusive of tariffs enacted thus far, and the European tariffs indicated this week. Obviously, more details are set to follow. But as we've said previously, we are positioned to respond, with mitigation actions identified and confirm our guidance towards the top end of the range this year.
最後,由於 Zantac 付款的後期階段,預計淨利息支出將低於先前預測的 5.5 億英鎊至 6 億英鎊。我們的指導包括迄今為止頒布的關稅以及本週顯示的歐洲關稅。顯然,更多細節即將公佈。但正如我們之前所說,我們已做好準備應對,確定緩解措施,並確認我們對今年最高範圍的指導。
Looking beyond, we remain very confident in our medium and longer-term outlooks to 2026 and '31. Next slide, please.
展望未來,我們對 2026 年和 2031 年的中長期前景仍然充滿信心。請看下一張投影片。
Moving to our road map, which illustrates our progress towards major milestones and upcoming value unlocks. We have made good progress through the first half on our priority assets. Looking forward, we expect this momentum to accelerate. We continue to plan for launches in half two with Blenrep, Blujepa, and Penmenvy, adding to Nucala COPD.
轉到我們的路線圖,它展示了我們在實現重要里程碑和即將到來的價值釋放方面取得的進展。上半年我們在優先資產方面取得了良好進展。展望未來,我們預計這股勢頭將會加速。我們繼續計劃在第二季推出 Blenrep、Blujepa 和 Penmenvy,並增加 Nucala COPD。
The FDA regulatory decision for depemokimab is due in December this year. And of the 14-scale opportunities that Emma mentioned, we will have pivotal trial readouts related to six of these over the coming 18 months.
FDA 將於今年 12 月做出 depemokimab 的監管決定。在 Emma 提到的 14 個規模機會中,我們將在未來 18 個月內對其中 6 個進行關鍵試驗讀數。
And with that, I will hand back to Emma to close.
說完這些,我會把話題交還給艾瑪來結束演講。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Thanks, Julie. To summarize, our results today confirm GSK's continued strong momentum and meaningful R&D progress for patients and for shareholders. Our portfolio is demonstrating quality and strength, and we now expect to be towards the top end of our financial guidance for 2025. Looking beyond, we're excited by the prospects in our pipeline and remain highly confident in our long-term outlook.
謝謝,朱莉。總而言之,我們今天的結果證實了葛蘭素史克繼續保持強勁勢頭,並為患者和股東取得了有意義的研發進展。我們的投資組合展現出高品質和實力,我們目前預計 2025 年的財務表現將達到預期的最高水準。展望未來,我們對我們的前景感到興奮,並對我們的長期前景充滿信心。
With that, I'll now open up the call for Q&A with all the team.
好了,我現在開始與整個團隊進行問答。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Thank you, Emma. I would like to remind everyone to please raise their hand to ask a question. First question comes from Simon Baker. Please go ahead, Simon.
謝謝你,艾瑪。我想提醒大家,如果要提問,請舉手。第一個問題來自西蒙·貝克。請繼續,西蒙。
Simon Baker - Analyst
Simon Baker - Analyst
Yeah, two questions, if I may, please. Firstly, just a clarification on camlipixant. Tony, you said they would both report in 2026. Slide 32 is still showing CALM-1 readout in H2 '25. So when you said report, do you mean the full data, and we will still get a CALM-1 headline press release in 2025?
是的,如果可以的話,請問兩個問題。首先,僅對 camlipixant 進行澄清。東尼,你說過他們都會在 2026 年報告。投影片 32 仍顯示 H2 '25 中的 CALM-1 讀數。那麼,當您說報告時,您是指完整的數據嗎?我們在 2025 年仍然會收到 CALM-1 的頭條新聞稿嗎?
And then the second question was related to Blenrep. We -- like you are assuming, this is simply a potential delay rather than anything else. So I just wanted to get your thoughts on what impact that has, firstly, on 2031 and the composition of the GBP40 billion if those Blenrep revenues are pushed out slightly and also what it means for 2028, where the contribution from Blenrep now looks like it will be smaller, and therefore, the impact from the dolutegravir patent expiry will be greater. Just how that -- what the magnitude of that is and also how that influences your M&A plans going forward? Thanks so much.
第二個問題與 Blenrep 有關。我們——就像您所假設的那樣,這只是一個潛在的延遲,而不是其他任何事情。因此,我只是想聽聽您的看法,首先,如果 Blenrep 的收入稍微推遲,會對 2031 年和 400 億英鎊的構成產生什麼影響,其次,這對 2028 年意味著什麼,現在看來,Blenrep 的貢獻會更小,因此,多替拉韋專利到期的影響會更大。那到底有多大──那有多大程度,以及那又如何影響您未來的併購計畫?非常感謝。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Thanks. Well, I'll ask Tony in a second, just to comment quickly on camlipixant. But to be really clear, Simon, we are very pleased to have an updated PDUFA date in October. There is absolutely no change to our expectations around the ramp of Blenrep. We're really pleased with the -- we're hoping to get into more than 10 markets, actually, by the end of this year. We're working hard and constructively with the FDA to be able to bring this to American patients, too. So no change. I'm fully confident whether it's our '28 outlook or '31 outlooks. And as you know, we keep adding to them with new prospects and ongoing BD.
謝謝。好吧,我馬上就問托尼,只是想快速評論一下 camlipixant。但要明確一點,西蒙,我們很高興在 10 月獲得了更新的 PDUFA 日期。我們對 Blenrep 坡道的預期完全沒有改變。我們對此感到非常高興——實際上,我們希望在今年年底前進入 10 多個市場。我們正在與 FDA 進行艱苦且建設性的合作,以便能夠將這種藥物帶給美國患者。所以沒有變化。無論是我們的‘28 年展望’還是‘31 年展望’,我都充滿信心。如您所知,我們不斷為他們增添新的前景和正在進行的 BD。
And specifically on your question on BD, it's quite exciting to me that three of the four pivotal trials that are starting later this year, whether it's on efi or IDRX or our next-gen of ADCs are from a great BD that we brought in. Of course, we announced Hengrui this week, which is a really strategic play to accelerate early stage research and with a headline assets, which might be best-in-class on the PDE3/4 for COPD as well.
具體來說,關於您關於 BD 的問題,令我非常興奮的是,今年稍後開始的四項關鍵試驗中,有三個,無論是關於 efi 還是 IDRX 或我們的下一代 ADC,都來自我們引入的優秀 BD。當然,我們本周宣布了恆瑞,這是一個真正具有戰略意義的舉措,旨在加速早期研究,並擁有頭條資產,在治療 COPD 的 PDE3/4 領域也可能是同類最佳。
So lots going on in BD. And we'll continue at the kind of pace and scale we have been. But no update at all, except for reiterated confidence in terms of our outlook and plans to add to them. Tony, anything you want to say on camli?
因此,BD 中發生了很多事情。我們將繼續保持現有的速度和規模。但沒有任何更新,除了重申對我們的前景的信心和增加計劃之外。托尼,你想在 camli 上說點什麼嗎?
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
Yeah. Simon, thanks for the question. And just as an update, and clarifying here, as I said before, CALM-2 is still recruiting. We're anticipating data in midyear '26. You'll also appreciate that typically, we only disclose Phase III studies involving two studies once both are completed. And so the formal disclosure associated with CALM-1 and CALM-2 will be in line with the CALM-2 schedule.
是的。西蒙,謝謝你的提問。再次更新並澄清一下,正如我之前所說,CALM-2 仍在招募中。我們預計 26 年中期將獲得數據。您也會意識到,通常情況下,我們只會在兩項研究都完成後才揭露涉及兩項研究的第三階段研究。因此,與 CALM-1 和 CALM-2 相關的正式揭露將與 CALM-2 時間表一致。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Next question comes from James Gordon from JPMorgan. James, please go ahead.
下一個問題來自摩根大通的詹姆斯戈登。詹姆斯,請繼續。
James Gordon - Analyst
James Gordon - Analyst
James Gordon, JPMorgan. First question was also on Blenrep. So a busy few weeks with the ODAC, and then it sounds like subsequent data added after the ODAC and then some personnel changes at FDA with Vinay Prasad leaving. So without asking what the extra data is, just what is GSK's latest confidence in getting Blenrep approved in the US this year? And also is -- how important is Blenrep US in keeping the margin flat through HIV LOE starting in '28? So if you didn't have US Blenrep, would you still be able to keep the margin flat? That's the first question, please.
摩根大通的詹姆斯戈登。第一個問題也是關於 Blenrep 的。因此,ODAC 過去幾週很忙,然後聽起來像是在 ODAC 之後添加了後續數據,然後 FDA 發生了一些人事變動,Vinay Prasad 離開了。因此,不問額外的數據是什麼,葛蘭素史克對今年 Blenrep 在美國獲得批准的最新信心究竟是什麼?而且—從 28 年開始,Blenrep US 對於透過 HIV LOE 維持利潤率平穩有多重要?那麼,如果沒有美國 Blenrep,您還能保持利潤率平穩嗎?這是第一個問題。
And then the second question, the PDE3/4 looks interesting for the Hengrui deal. So I think based on like $10 billion to get Verona's PDE3/4, but that is already in the market, and you're paying about GBP 500 million, but it's quite a bit earlier. So is the key differentiation that yours is DPI versus nebulizer or were other areas where it's differential and you're only paying about 5% what Merck did? So is it just how far you are from the market. It looks like a very good deal, but it depends how differentiated it is.
然後是第二個問題,PDE3/4 對於恆瑞交易看起來很有趣。所以我認為需要花費 100 億美元來獲得維羅納的 PDE3/4,但該產品已經上市,而您需要支付大約 5 億英鎊,但這還為時過早。那麼,你們的主要區別在於 DPI 與霧化器的區別,還是其他領域的區別,而你們只支付默克公司所支付費用的 5% 左右?那麼問題就在於你距離市場有多遠。這看起來是一筆非常好的交易,但這取決於它的差異化程度。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Well, we definitely agree. It's a very good deal. And yes, the market deals is not how much you spend, it's the kind of returns you can get. And we do believe we have a potentially best-in-class asset here in a field we know a lot about and adding to the COPD portfolio. I mean, I think there are about seven questions in that.
嗯,我們絕對同意。這是一筆非常好的交易。是的,市場交易的不是你花了多少錢,而是你能獲得什麼樣的回報。我們確實相信,在我們非常了解的領域,我們擁有潛在的最佳資產,並將其添加到 COPD 產品組合中。我的意思是,我認為這裡大約有七個問題。
But in your first point on Blenrep, and just for everybody, as Tony said, we know you've got a lot of questions about that, but we hope everybody on the call understands how much we are committed to respecting the confidentiality of this process. We are in constructive dialogue. We have high confidence in our data. We're answering questions and adding more to that, and we'll update you when we can.
但是,正如托尼所說,關於 Blenrep 的第一個觀點,我們知道您對此有很多疑問,但我們希望電話中的每個人都明白,我們致力於尊重這一過程的保密性。我們正在進行建設性對話。我們對我們的數據非常有信心。我們正在回答問題並添加更多內容,我們會盡快向您更新。
And just to reiterate, we don't subsegment our peak year sales by country, obviously. The US is important, but we're really pleased to have added -- by the way, since the ODAC, the across the board Europe approval, the Canada approval to the UK to Japan. And you can rest assured that Luke is ramping up for launch preparations, of course, going slow to go big. And yes, Blenrep is without doubt, an important medicine. We are working towards the US approval.
再次重申一下,我們顯然不會按國家細分我們的高峰年銷售額。美國很重要,但我們真的很高興能夠加入——順便說一句,自從 ODAC 以來,歐洲全面批准,加拿大批准,英國批准,日本批准。你可以放心,盧克正在加緊準備發射,當然,他會慢慢來,爭取更大的成功。是的,Blenrep 毫無疑問是一種重要的藥物。我們正在努力爭取美國的批准。
We want to bring this for American patients. When you think of this overall survival data in a head-to-head study, against the standard of care, when you think that 70% of myeloma patients are in communities, and this is a medicine that it allows people to be treated in communities. So we'll keep the conversation going there.
我們希望為美國患者帶來這一點。當您在頭對頭研究中考慮整體生存數據時,與護理標準相比,當您認為 70% 的骨髓瘤患者都在社區中時,這是一種允許人們在社區中接受治療的藥物。因此我們會繼續進行對話。
I'll see whether Tony wants to add anything at all. He's shaking his head. Anything you want to say?
我會看看托尼是否想補充一些內容。他搖搖頭。有什麼想說的嗎?
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
Just simply, again, to emphasize that obviously, we're in constructive dialogue, but we want to respect the confidentiality of that interaction. I'll update you as soon as I can.
只是再次強調,顯然我們正在進行建設性對話,但我們希望尊重這種互動的保密性。我會盡快向您通報最新情況。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Great. Thanks. And just because we want to get through as many questions as possible, I would respectfully suggest that we're not going to go much further than that on Blenrep today.
偉大的。謝謝。只是因為我們想盡可能地解答問題,所以我謹建議我們今天在 Blenrep 上不要討論太多。
Sorry, the 3/4 yes. Tony or maybe Luke could be good because I know --
抱歉,3/4 是。東尼或盧克可能不錯,因為我知道--
Luke Miels - Chief Commercial Officer
Luke Miels - Chief Commercial Officer
Yeah, do you want to cover why you like the profile and if I can --
是的,你想解釋為什麼你喜歡這個簡介嗎?如果我可以的話--
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
Yes, I'll start with why I like the collaboration for stock, because the GBP 500 million is also dedicated towards options to the other 11 innovative potential medicines that we have covering RI&I and oncology. Let me just describe the profile of the molecule itself. I would describe it in terms of its PDE3/4 balance as being similar to Verona. That's important because it means that we can be confident in the efficacy and safety profile of the molecule. Whilst it's similar in balance, it's about twofold more potent across that and has demonstrated both clinically and preclinically, both bronchodilation and anti-inflammatory effects.
是的,我首先要說一下為什麼我喜歡股票合作,因為這 5 億英鎊還專門用於我們涵蓋 RI&I 和腫瘤學的其他 11 種創新潛在藥物的選擇。讓我只描述一下分子本身的概況。我會從 PDE3/4 平衡的角度來描述它與維羅納相似。這很重要,因為這意味著我們可以對該分子的功效和安全性充滿信心。雖然平衡性相似,但其效力大約高出兩倍,並且在臨床和臨床前都已證明具有支氣管擴張和抗發炎作用。
That reduction in dose is important when one considers the optionality for DPI. And as Emma said, we have an extensive experience there based on our own DPI portfolio. And I'm looking forward to developing that molecule and partnership. And we see potential really across the gold framework as an add-on therapy.
當考慮 DPI 的可選性時,減少劑量非常重要。正如艾瑪所說,基於我們自己的 DPI 產品組合,我們在那裡擁有豐富的經驗。我期待著開發這種分子和建立合作關係。我們確實看到了黃金框架作為附加療法的潛力。
Luke, do you want to add a bit more to that?
路克,你還想補充一點嗎?
Luke Miels - Chief Commercial Officer
Luke Miels - Chief Commercial Officer
Yeah. I mean, we've obviously looked at this class for a while for a couple of years now. We like it. I think the initial uptake is pretty clear. I think about 50% of the use is in very severe patients on top of standard of care, triple, et cetera.
是的。我的意思是,我們顯然已經研究這個課程好幾年了。我們喜歡它。我認為最初的反應是相當明顯的。我認為大約 50% 的使用是在標準護理、三重治療等基礎上針對病情嚴重的患者。
But I think there will be a threshold, where nebulization and the price starts to retard -- let our hypothesis anyway, starts to retard things. So an alternative classical delivery approach, which is very synergistic with the rest of the portfolio is exciting. And then the final thing I'd say is it's a good sign for COPD and -- Nucala and COPD because clearly, there's an appetite for new mechanisms in particularly the more severe COPD population.
但我認為會有一個閾值,霧化和價格開始減緩 - 無論如何,我們的假設開始減緩事情。因此,一種與投資組合的其他部分具有高度協同作用的替代性傳統交付方法令人興奮。最後我想說的是,這對 COPD 來說是一個好兆頭——Nucala 和 COPD,因為很明顯,人們對新機制有需求,特別是對於更嚴重的 COPD 族群。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Yeah. I mean -- and we're really pleased with the agility, frankly, aggression we've been showing on partnering for BD as of assets out of China, whether it's the ADC deal we did or the long-acting TSLP or now adding this. And of course, there's some great signs. We all know what's happening in the biotech industry there. But then we can pick up partnering and then rolling through Internet or global ex-China clinical network and of course, manufacturing, if that's successful.
是的。我的意思是——坦白說,我們對我們在與 BD 合作開發中國境外資產方面所表現出的敏捷性、積極性感到非常滿意,無論是我們達成的 ADC 交易還是長效 TSLP,或者現在添加的這個。當然,也有一些很好的跡象。我們都知道那裡的生物技術產業正在發生什麼。但隨後我們可以選擇合作,然後透過網路或全球除中國以外的臨床網路進行推廣,當然,如果成功的話,還可以進行製造。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
The next question comes from Michael Leuchten from Jefferies. Please go ahead, Michael.
下一個問題來自 Jefferies 的 Michael Leuchten。請繼續,邁克爾。
Michael Leuchten - Analyst
Michael Leuchten - Analyst
Two please, one for Julie and one for Luke. Julie, you talk to the supply chain costs hitting COGS in the second quarter, and then your slides say you expect the gross margin to benefit from product mix, but it does say the gross margin is going to go up. Can you just clarify what those costs might mean for the second relevant or not?
請給我兩份,一份給朱莉,一份給路克。朱莉,您談到第二季度供應鏈成本觸及銷貨成本,然後您的幻燈片說您預計毛利率將受益於產品組合,但確實說毛利率會上升。您能否解釋一下這些成本對於第二個相關因素而言意味著什麼?
And a question for Luke, Nucala COPD, you've got GBP500 million peak sales on the slide now. I thought in the past, you talked to GBP500 million to GBP1 billion. I might be wrong. But have your expectations come down for that relative to previous communication? Thank you.
我要問盧克,Nucala COPD,您目前的峰值銷售額已達到 5 億英鎊。我以為你過去談論的是 5 億英鎊到 10 億英鎊。我可能錯了。但與先前的溝通相比,您的期望值是否有所下降?謝謝。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Definitely not, I'll say, before Luke answers your question. And Julie, do you want to talk about gross margin? Recognizing remember that we have included in our guidance, not only those enacted, but those indicated in terms of tariffs. So as that settles out with a bit more details to come, we'll have more specificity.
在盧克回答你的問題之前,我會說絕對不是。朱莉,你想談談毛利率嗎?請記住,我們的指導中不僅包括已頒布的規定,還包括關稅方面指出的規定。因此,隨著更多細節的確定,我們將提供更具體的資訊。
But Julie, do you want to pick up on gross margin, and then Luke?
但是朱莉,你想了解一下毛利率嗎?然後盧克呢?
Luke Miels - Chief Commercial Officer
Luke Miels - Chief Commercial Officer
Yeah, sure. Thank you very much for the question. So in terms of gross margin, we do anticipate some accretion this year. As you know, we took a charge for supply chain efficiencies in Q4 of last year of GBP150 million. So we will be comping that coming up with the fourth quarter.
是的,當然。非常感謝您的提問。因此,就毛利率而言,我們確實預計今年會有所成長。如您所知,我們去年第四季為提高供應鏈效率花費了 1.5 億英鎊。因此我們將在第四季度對此進行補充。
But nevertheless, the big point is that the Specialty growth, which is very considerable, is driving an improvement in our gross margin. If all else was equal, you would see that coming through. What you see is causing some turbulence in the gross margin is, one, supply chain optimization charges are going through. And then the second one, as Emma just alluded to, is tariffs.
但無論如何,最重要的是專業業務的成長非常可觀,推動了我們毛利率的提高。如果其他一切都相同,你會看到這一點。您所看到的毛利率出現一些波動的原因是,第一,供應鏈優化費用正在發生。第二個問題,正如艾瑪剛才提到的,就是關稅。
Obviously, we haven't had any tariffs in the first half. We are anticipating some coming in the second half, and that will lower the gross margin slightly. But even with the ones that have either been announced or indicated, we still see the opportunity for gross margin accretion coming through mix. Luke?
顯然,上半年我們還沒有任何關稅。我們預計下半年會出現一些變化,這將略微降低毛利率。但即使對於已經宣布或表明的舉措,我們仍然看到透過組合實現毛利率成長的機會。盧克?
Yeah. Thanks, Michael. Look, I think GBP500 million is fair. But of course, we are going to add above that. If I look at initial signs, we're already ahead of where Dupixent was at the same point in its launch with new patient starts.
是的。謝謝,麥可。看,我認為 5 億英鎊是公平的。但當然,我們會在上面添加內容。如果從初步跡象來看,我們已經領先 Dupixent 在新患者開始治療方面的推出。
So that's a good sign. We don't -- I mean, the lead indicators are positive. So physicians clearly like the reduction in hospitalization and ED department visits, and that certainly resonates with them. We're also interestingly winning in terms of the perception in the lower EOS patient as well, which is naturally historically Dupi's hunting ground, which is encouraging.
這是一個好兆頭。我們不會——我的意思是,領先指標是正面的。因此,醫生們顯然對住院和急診就診次數的減少感到高興,這無疑引起了他們的共鳴。有趣的是,我們在較低 EOS 患者的感知方面也取得了勝利,這自然是歷史上 Dupi 的狩獵場,這是令人鼓舞的。
And if you look at the market research we've got, again, early days, but 67% of pulmonologists say they're likely to prescribe Nucala COPD and prefer it versus only 30% with Dupixent. And really good execution so far. We've seen 91% of our key customers with a really good frequency. So bang on there.
如果你看我們進行的市場調查,你會發現,雖然還處於早期階段,但 67% 的肺科醫生表示,他們可能會開出 Nucala COPD 藥物,並且更喜歡它,而只有 30% 的人更喜歡 Dupixent。到目前為止,執行效果確實很好。我們與 91% 的關鍵客戶見面的頻率非常高。所以就去那裡吧。
I think balancing that back to your question is pulmonologists historically have not been as aggressive as maybe the evidence would support in terms of biologic penetration. So once we get more robust numbers, which will be IQVIA, the (inaudible) the lag indicators, we'll have a better picture. But I think it's a good start, and we'll give you a full update at Q3 when we've got data, which, of course, is what counts (inaudible).
我認為,平衡一下你的問題,從歷史上看,肺科醫生在生物滲透方面可能並不像證據所支持的那樣積極。因此,一旦我們獲得更可靠的數字,即 IQVIA,(聽不清楚)落後指標,我們就會有更清楚的了解。但我認為這是個好的開始,當我們獲得第三季的數據時,我們會提供大家完整的更新,當然,這才是最重要的(聽不清楚)。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
And the other thing I'd say on this one is what we're aiming to do is be indisputable leaders in COPD medicines. That is the strategy that Tony has laid out with a comprehensive portfolio that we've added to be able to subsegment and treat this enormous burden of disease. More than 300 million people, third leading cause of death, 70%, as Luke said, the costs related to COPD or hospitalization. Nucala is the only medicine with a demonstrated 35% reduction in hospitalization. Tony confirmed the start of the depe COPD trial.
我想說的另一件事是,我們的目標是成為 COPD 藥物領域無可爭議的領導者。這就是 Tony 制定的策略,他透過全面的產品組合,對這一巨大的疾病負擔進行細分和治療。超過3億人,第三大死因,70%,正如盧克所說,與COPD或住院相關的費用。Nucala 是唯一一種被證實可將住院率降低 35% 的藥物。托尼確認開始深度 COPD 試驗。
So one of the things that might contain over time, the [peakiest] of Nucala is bringing a six-monthly IL-5 to COPD. And then, of course, we've got the long -- we've got the whole portfolio of assets that we've already started talking about. So exciting start. I think we confirmed and reiterated GBP0.5 billion for this one, but let's see how it goes.
因此,隨著時間的推移,Nucala 最高峰可能會帶來的其中一件事就是為 COPD 帶來每六個月一次的 IL-5。當然,我們已經有了長期的——我們已經有了已經開始談論的整個資產組合。如此令人興奮的開始。我認為我們已經確認並重申了此次投資 5 億英鎊,但讓我們看看進展如何。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Next question comes from Sachin Jain from Bank of America. Sachin, please go ahead.
下一個問題來自美國銀行的 Sachin Jain。薩欽,請繼續。
Sachin Jain - Analyst
Sachin Jain - Analyst
I got two or three product ones, please. So firstly, on the same vein on depe. Luke, I wonder if you could just give us a better sense of launch, how you think about market expansion, Nucala cannibalization switches from competition. And I guess, specifically, consensus is only GBP200 million for next year, which seems conservative relative to the launch you potentially described.
我有兩到三個產品,請問一下。因此,首先,在依賴方面也是同樣的道理。盧克,我想知道您是否可以讓我們更好地了解發布情況,您如何看待市場擴張,以及 Nucala 從競爭中蠶食轉變。而且我猜,具體來說,大家一致認為明年的預算僅為 2 億英鎊,相對於您可能描述的發布規模而言,這似乎是保守的。
Secondly, on Shingrix, I wonder if you could talk about continuation of the ex-US trends and how much of those European launches potentially boluses versus continuing. And thirdly, I will apologize, but I will try my arm once on Blenrep. Just want to understand why the data you've submitted, you wouldn't have used as part of the AdComm debate if it was material enough to shift the debate you knew was coming. Thank you.
其次,關於 Shingrix,我想知道您是否可以談談美國以外趨勢的延續性,以及這些歐洲產品中有多少是潛在的推注藥物,有多少是持續性的。第三,我要道歉,但我還是想在 Blenrep 上嘗試一次。只是想了解為什麼如果您提交的數據足以改變您所知道的即將發生的辯論,您就不會將其用作 AdComm 辯論的一部分。謝謝。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Sorry, I didn't -- it wasn't on purpose, but I didn't actually hear the third question on Blenrep. Could you repeat it?
抱歉,我沒有——不是故意的,但我實際上沒有聽到 Blenrep 上的第三個問題。你能重複一遍嗎?
Sachin Jain - Analyst
Sachin Jain - Analyst
Why data that you've submitted, you wouldn't have used as part of the AdComm debate if it's material enough to shift the FDA's view on a debate that you knew was coming and you get the briefing documents well ahead of the actual AdComm? Thanks.
為什麼您提交的數據不會用作 AdComm 辯論的一部分,如果您知道這些數據足以改變 FDA 對即將舉行的辯論的看法,並且您在實際 AdComm 之前就獲得了簡報文件?謝謝。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Yeah. We're not going to comment on that. So good try. But Luke, would you like to answer the first two questions on ambitions around depe and Shingrix curves? Thanks.
是的。我們不會對此發表評論。非常好的嘗試。但是盧克,你願意回答關於 depe 和 Shingrix 曲線的野心的前兩個問題嗎?謝謝。
Luke Miels - Chief Commercial Officer
Luke Miels - Chief Commercial Officer
And welcome back, Sachin. Yeah. Look, I think on depe, a lot of excitement. I think for anyone that's attended an academic meeting with the data has been presented, I think there's a lot of enthusiasm here, and I'll quote some numbers to the market research. Inside, of course, the track record of this team with Nucala and executable stock is very good. There's a high excitement there. I think with physicians, there's also a high anticipation.
歡迎回來,Sachin。是的。瞧,我認為從根本上來說,有很多令人興奮的事情。我認為對於任何參加過學術會議並已經展示過數據的人來說,我認為這裡有很多熱情,我會引用一些市場研究的數字。當然,在內部,這支擁有努卡拉和可執行股票的球隊的成績非常好。那裡氣氛十分熱鬧。我認為醫生們也抱有很高的期待。
We've got really robust data here in controlled studies. And I think most people can see that efficacy, but also have the imagination to understand in the real environment with less supervision that data hopefully should improve, and we've got a program to capture that.
我們在對照研究中獲得了非常可靠的數據。我認為大多數人不僅能夠看到這種功效,而且也有想像去理解在監督較少的真實環境中數據有望得到改善,我們已經有一個程序來捕捉這一點。
Look, I won't go into the strategy and positioning, but the testing response is really clear. When we've taken that profile and that strategy to pulmonologists and allergists, 94% of them are motivated to prescribe the product. 70% think it's more compelling than competitors. And 87% of patients I cited certainly prefer it if the HCP would recommend it. We've done other forms of market research. Again, 86% of HCPs think it will be standard of care and 82% would consider prescribing it. And that's before the launch, right? I mean, we don't have a field force out there. This is very organic.
看,我不會深入討論策略和定位,但測試響應確實很明確。當我們將這項概況和策略帶給肺病專家和過敏症專家時,其中 94% 的人願意開出該產品。 70% 的人認為它比競爭對手更有吸引力。我引用的 87% 的患者肯定會更喜歡它,如果 HCP 推薦的話。我們也做過其他形式的市場調查。再一次,86% 的 HCP 認為它將成為標準治療方法,82% 的 HCP 會考慮開出它。那是在發射之前,對嗎?我的意思是,我們在那裡沒有實地部隊。這是非常有機的。
Look, the [bio-pen] is [27%] right now in severe asthma and around 12% in nasal polyps. And I've quoted this before, but if you look at biologics at the end of 12 months, you've lost about 65% of those patients. So a combination of in-office administration, lower frequency of administration, a validated known target, excellent benefit risk profile, I think it's going to be very exciting.
你看,目前 [生物筆] 對嚴重氣喘的治療率為 [27%],對鼻息肉的治療率為 12% 左右。我之前也引用過這一點,但如果你看看 12 個月後的生物製劑,你會發現大約有 65% 的患者已經失去了治療。因此,結合辦公室管理、較低的管理頻率、經過驗證的已知目標、出色的效益風險狀況,我認為這將非常令人興奮。
We've also shown historically with Trelegy that we can target the competition without disrupting our own business too extensively. So the hierarchy will be Dupixent first and then FASENRA, which makes sense. And the incentive scheme in the organization, obviously, will drive that, and there'll be limited points for switching Nucala. So yeah, very exciting there.
我們與 Trelegy 合作的歷史也證明,我們可以瞄準競爭對手,而不會過度擾亂我們自己的業務。因此層次結構將首先是 Dupixent,然後是 FASENRA,這是有道理的。顯然,組織內的激勵計劃將推動這一點,而轉換 Nucala 所獲得的積分將是有限的。是的,那裡非常令人興奮。
If I go to Shingrix, so continuation of ex-US trend. I mean, yes, if you look at what's going on there, I mean, we like to do what we say we're going to do, and I think this is an example of that. It's not apples-to-apples. But because the US has a much broader coverage, you've got coverage for 50 years plus versus EU markets in Japan and others, where they have a higher age cutoff, and even within countries and provinces that can vary quite a bit. But the US is a steady climb still. We've got 42%. So that's in line with what we said, 3% to 5% penetration a year.
如果我去 Shingrix,那麼美國以外的趨勢就會延續。我的意思是,是的,如果你看看那裡發生的事情,我的意思是,我們喜歡做我們說過要做的事,我認為這就是一個例子。這不是同類的。但由於美國的覆蓋範圍更廣,可以享有 50 多年的保障,而日本等歐盟市場的年齡限制則更高,甚至在各國和省份內,保障年齡也會有很大差異。但美國仍在穩步攀升。我們得到了 42%。所以這與我們所說的一致,每年滲透率 3% 到 5%。
Germany, we're about 26%. We had a bit of a soft August last year, and a lot of work there, but we've worked out what happened there. And we're now back on a good growth trajectory using a strategy that we're now employing in the US and Japan. And this was based on the success we had in Australia, where we're approaching 40% penetration in that market. And that was really targeting comorbid patients, promoting directly to specialists like cardiologists, allergists rather than just a broad approach.
德國約佔26%。去年八月我們的業績有些疲軟,我們在那裡做了很多工作,但我們已經解決了那裡發生的問題。現在,我們透過採用目前在美國和日本實施的策略,又回到了良好的成長軌道。這是基於我們在澳洲的成功,我們在該市場的滲透率已接近 40%。這確實針對的是合併症患者,直接向心臟科醫生、過敏症專家等專家推廣,而不僅僅是採取廣泛的方法。
If you look structurally, typically, if you've got heavy funding, full funding, you've got penetrations, which are changing and growing between 8% and 29%, not including the US and growing. If there's limited funding like the UK, Spain, Italy, China, then you've got a penetration range of around 4% to 8%, but also growing. And there is the opportunity, of course, to change that as we've seen in Japan. So Japan had limited funding. It's now got much broader funding. And actually, it's a key driver for Shingrix over and above France.
如果從結構來看,通常情況下,如果你有大量資金、全額資金,那麼你的滲透率就會發生變化,成長率在 8% 到 29% 之間,這還不包括美國,而且還在成長。如果資金有限,例如英國、西班牙、義大利、中國,那麼滲透率將在 4% 到 8% 左右,而且還在增加。當然,正如我們在日本看到的那樣,有機會改變這種狀況。因此日本的資金有限。現在它獲得了更廣泛的資金支持。事實上,它是 Shingrix 在法國以外地區發展的關鍵驅動力。
And then if it's out of pocket, you've got penetration range of 3% to 4%. So something to keep in mind for emerging markets. So yeah, I think there's remaining potential outside the US. We're still very focused on the US, but hopefully, those numbers are helpful, Sachin, and answers your question.
如果是自付費用,滲透率範圍為 3% 到 4%。因此,對於新興市場來說,需要牢記這一點。是的,我認為美國以外仍有潛力。我們仍然非常關注美國,但希望這些數字能夠有所幫助,Sachin,並回答你的問題。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Next question comes from Kerry Holford from Berenberg. Kerry, please go ahead.
下一個問題來自貝倫貝格的 Kerry Holford。克里,請繼續。
Kerry Holford - Analyst
Kerry Holford - Analyst
And just maybe a broad US question here. Any commentary you can give us more broadly on the discussions you've been having with the US administration on tariffs, but also in the context of MFN. How have those discussions evolved? And how do you think the administration intends to balance those two items, introducing tariffs, offset and balancing that with the proposed plans to lower drug prices in the US? Any directional commentary you would be prepared to make at this point would be very helpful.
這也許只是美國的一個廣泛問題。您能否就您與美國政府就關稅問題進行的討論以及最惠國待遇問題的背景,給我們提供更廣泛的評論?這些討論進展如何?您認為政府打算如何平衡這兩項,即徵收關稅、抵銷以及與降低美國藥品價格的擬議計劃相平衡?此時您準備做出的任何方向性評論都將非常有幫助。
And then secondly, also on this -- the focus here in the US. The Trump administration has indicated support for DTC cash pay options for US patients. Clearly, this is being utilized with obesity today. Is the DTC route to market, a route you would consider in the US? And if so, which drugs within your portfolio might best fit that approach? Thank you.
其次,這也是美國的重點。川普政府已表示支持為美國患者提供 DTC 現金支付選項。顯然,這在今天正被用於治療肥胖症。您會考慮在美國採用 DTC 市場途徑嗎?如果是這樣,您的產品組合中哪些藥物最適合這種方法?謝謝。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Yeah, thanks. So look, first, in terms of tariffs, as we said, we've included in our outlook, not only those that are enacted, but those indicators, but it is important to reiterate that we're waiting on the 232 investigation and the sort of specifics of that still need to become clearer. I think it would be fair to say that you always have to separate from headlines to the reality of what's delivered. And whilst on the one hand, we're now seeing numbers and indications that perhaps are not as high as in the first run of this. On the other hand, it is very, very real in terms of focused on US manufacturing and sourcing.
是的,謝謝。因此,首先,就關稅而言,正如我們所說,我們的展望不僅包括已頒布的關稅,還包括那些指標,但必須重申的是,我們正在等待 232 調查,其具體細節仍需要變得更加清晰。我認為可以公平地說,你必須始終將頭條新聞與事實分開。一方面,我們現在看到的數字和跡象可能不如第一次那麼高。另一方面,從專注於美國製造和採購的角度來看,這是非常非常現實的。
Now the really good news for GSK, as I said last quarter, is we are well positioned on this. Since (technical difficulty) US, we've taken the business from being less than 40% to being more than 50% of the company now. And in fact, our Specialty business, which is where the pipeline is focused and the innovations focus and the growth focus is two-thirds of that so far this year is in the US.
正如我上個季度所說,對葛蘭素史克來說,真正的好消息是我們在這方面處於有利地位。自從(技術困難)美國以來,我們的業務占公司比重從不到 40% 上升到現在的 50% 以上。事實上,我們的專業業務,即通路重點、創新重點和成長重點,今年到目前為止的三分之二都在美國。
So we're well positioned for that. We're well positioned on manufacturing. We broke ground on another new factory. Some of the supply chain optimizations Julie referred to is also setting up some -- certain shifts of some of our production. So we'll continue to be agile around it. But whilst we'd rather spend any incremental costs more on the pipeline. And as you know, we prioritize spending on R&D, and we're pleased to be increasing that ahead of top line again this year. We think we're positioned well to find solutions as this evolves.
因此,我們已做好充分準備。我們在製造業方面處於有利地位。我們又動工興建另一家新工廠。朱莉提到的一些供應鏈優化也正在設定一些——我們部分生產的某些轉變。因此,我們將繼續對此保持敏捷反應。但是我們寧願將增量成本更多地花在管道上。如您所知,我們優先考慮研發支出,我們很高興今年這筆支出再次超過營業收入。我們認為,隨著事態的發展,我們有能力找到解決方案。
On MFN, still very much moving around. But I think alongside others, yes, we're in discussions. Yes, we really want to prioritize keeping the US as the best market for innovation and also to deploy access to innovation and to make sure that we're passing on discounts given to patients so that medicines are sustainably affordable. We also would like to see more countries investing in medicines, which is such a small fraction of the total cost of healthcare.
關於最惠國待遇,目前仍有很大分歧。但我認為,與其他人一樣,我們正在進行討論。是的,我們確實希望優先將美國作為最佳創新市場,同時也要部署創新管道,並確保我們將折扣傳遞給患者,以便藥品可以持續負擔得起。我們也希望看到更多國家投資藥品,因為藥品只佔醫療保健總成本的一小部分。
And that's why our pipeline is really important here because so many of the examples we've talked to you about are cost sparing, whether it is COPD, or frankly, the fact that Blenrep can be community administered rather than long stays in hospital, whether it is the adherence of depe with that over 70% reduction, or of course, the best way to stop disease before it starts being vaccinations. So we continue to have that dialogue, and we will update you alongside others, no doubt, as it becomes clearer.
這就是為什麼我們的管道在這裡非常重要,因為我們與您討論的許多例子都節省了成本,無論是慢性阻塞性肺病,還是坦率地說,Blenrep 可以在社區管理而不是長期住院,無論是堅持服用 depe 可減少 70% 以上,當然,在疾病開始之前阻止疾病的最佳方法是接種疫苗。因此,我們會繼續進行對話,毫無疑問,隨著情況變得更加明朗,我們也會與其他人一起向您通報最新情況。
And yes, I do think they are all interlinked alongside trade discussions. And on DTC, that's definitely part of the things we're being open to. But maybe I'll ask Luke to comment on how we see some differences in the portfolio around that.
是的,我確實認為它們都與貿易討論相互關聯。對 DTC 來說,這絕對是我們願意接受的事情之一。但也許我會請盧克評論一下我們如何看待投資組合中的一些差異。
Luke Miels - Chief Commercial Officer
Luke Miels - Chief Commercial Officer
Yeah. Thanks, Kerry. I mean, I think the first thing is the price has to be lower than someone can get it through their own program or insurance program. And then secondly, I mean, there are some products like Blujepa that could be amenable to that. We're looking more broadly at products like Trelegy, and we've got an open mind.
是的。謝謝,克里。我的意思是,我認為首先價格必須低於人們透過自己的計劃或保險計劃獲得的價格。其次,我的意思是,有些產品(例如 Blujepa)可以適應這種情況。我們正在更廣泛地審視像 Trelegy 這樣的產品,並且我們持開放態度。
There's clearly an opportunity in certain subpatient segments. We've seen that, as you mentioned, with GLP-1s. But I think it's very much, as Emma said, a watching brief at this point, but we can move very quickly once things settle out, we know what the rules are.
某些亞患者群體顯然存在機會。正如您所提到的,我們已經在 GLP-1 中看到了這一點。但我認為,正如艾瑪所說,目前這只是一個觀察階段,但一旦事情平息下來,我們就可以迅速採取行動,因為我們知道規則是什麼。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Next question comes from Matthew Weston from UBS. Matthew, please go ahead.
下一個問題來自瑞銀的馬修‧韋斯頓。馬修,請繼續。
Matthew Weston - Analyst
Matthew Weston - Analyst
Hopefully, you can hear me. One quick comment and then two questions, if I can. The quick comment is just to actually say, Michael is right, the GSK Respiratory Investor Deep Dive event, Nucala COPD peak-year sales was GBP500 million to GBP1 billion. But anyway, we take your comments. Two product questions, if I can.
希望你能聽到我的聲音。如果可以的話,我先簡短評論一下,然後問兩個問題。簡短的評論實際上是說,邁克爾是對的,GSK 呼吸道投資者深入探討活動,Nucala COPD 高峰年銷售額為 5 億至 10 億英鎊。但無論如何,我們會接受您的評論。如果可以的話,我想問兩個產品問題。
Camlipixant, Tony, the CALM-1 program does seem to be rolling back in terms of time line now second half of '26. If we've got such unmet need in chronic cough, clear efficacy, what's holding patients and physicians back from signing up to the trial? Or are we wrong, we just had the timing too early?
Camlipixant,托尼,CALM-1 計劃確實似乎在時間線方面出現倒退,現在是 26 年下半年。如果我們在慢性咳嗽方面有如此未滿足的需求,且療效明確,那麼是什麼阻礙了病人和醫生報名參加試驗呢?還是我們錯了,我們只是時機把握得太早了?
And then secondly, I am going to chance my arm, Blenrep.
其次,我要冒險一試,Blenrep。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Go for it.
大膽試試吧。
Matthew Weston - Analyst
Matthew Weston - Analyst
It's just on study design of the existing studies which are still ongoing. Have you decided to change any protocols, recruit more US patients, or optimize anything in light of what you heard at the AdComm?
這只是對仍在進行的現有研究的研究設計。根據您在 AdComm 上聽到的內容,您是否決定改變任何協議、招募更多美國患者或優化任何內容?
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
So I'm not sure there is going to be much to add on Blenrep for the reasons we've said. But Tony, if you want to add anything at all, please go ahead, and then perhaps you can answer on currently. I will just say there is no change to our level of ambition on Nucala COPD. But Tony, do you want to comment on that?
因此,出於我們所述的原因,我不確定 Blenrep 上是否還有很多內容需要添加。但是托尼,如果你想添加任何內容,請繼續,然後也許你可以就目前情況進行回答。我只想說,我們對 Nucala COPD 的雄心壯志沒有改變。但是托尼,你想對此發表評論嗎?
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
Just simply, in general, on recruitment and forward-looking oncology studies, where we're enacting extensive plans to ensure that we have greater US representation going forward. In the case of the studies we have conducted, they were not a typical with representation in myeloma studies, and we were careful to ensure that the outcomes and demographics we felt were consistent in European patients. But more importantly, going forward, we have an extensive focus on US representation.
簡單來說,總的來說,在招募和前瞻性腫瘤學研究方面,我們正在製定廣泛的計劃,以確保我們在未來擁有更多的美國代表性。就我們所進行的研究而言,它們並不是骨髓瘤研究中的典型代表,我們謹慎地確保我們認為的結果和人口統計與歐洲患者一致。但更重要的是,展望未來,我們將廣泛關注美國的代表性。
Then just if you mind, if I just run straight into camlipixant --
如果你介意的話,如果我直接去吃 camlipixant--
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Yeah, I think it's worth clarifying this (inaudible).
是的,我認為有必要澄清一下(聽不清楚)。
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
Yeah. And look, so first of all, there is nothing proving difficult about the camlipixant studies. You will remember earlier, I identified that in CALM-2, we've been given the opportunity to add a larger proportion of higher frequency coughers into the study. That is the group for which we feel the pharmacology is more likely to be representative. And in addition, you'll also recall that because of the difficulties that Merck encountered in the design, the recruitment and other features of the study, we are taking careful action to ensure that we have covered all of that, both in terms of prescreening and other features associated with, for example, the cough counter.
是的。首先,camlipixant 研究沒有任何困難。您可能之前還記得,我之前指出,在 CALM-2 中,我們有機會將更大比例的高頻率咳嗽者添加到研究中。我們認為藥理學更可能代表這群人。此外,您還會記得,由於默克在研究的設計、招募和其他方面遇到的困難,我們正在採取謹慎的措施,以確保我們涵蓋了所有這些方面,包括預先篩選和其他相關方面,例如咳嗽計數器。
As I said, CALM-2 is proceeding on track as we planned. We are recruiting into the study right now. It is a six-month completion. When we are closer to full recruitment into that, I will know more about the precise date, but we are on track for middle of next year. And as I said to Simon, we will, as we typically do with our Phase III studies, where we have two studies ongoing, combine both results into the analysis before the submission.
正如我所說,CALM-2 正在按照我們的計劃順利進行。我們目前正在招募研究對象。該項目耗時六個月完成。當我們接近全面招募時,我會知道更多關於具體日期的信息,但我們計劃在明年年中完成。正如我對西蒙所說的那樣,我們將像通常在第三階段研究中所做的那樣(我們目前正在進行兩項研究),在提交之前將兩項研究的結果合併到分析中。
So there is nothing behind that in terms of any difficulties associated with the study other than the plan that we've already described, which is ensuring that what we see as being the unique profile that camlipixant offers both in terms of its efficacy. And I'll remind you in the (inaudible) study, we saw a 34% reduction in cough frequency relative to placebo and in terms of its selectivity profile, which in simple terms is about 10 times better than gefapixant and is therefore likely to result in fewer dropouts and will certainly not unblind the study.
因此,除了我們已經描述的計劃之外,與研究相關的任何困難都不會造成影響,這是為了確保我們所看到的 Camlipixant 在功效方面所提供的獨特特性。我要提醒大家,在(聽不清楚)研究中,我們發現與安慰劑相比,咳嗽頻率減少了 34%,就其選擇性而言,簡單來說,這比吉法匹拉嗪好 10 倍左右,因此可能會導致更少的退出,並且肯定不會揭盲研究。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Next question comes from Peter Verdult from BNP Paribas. Peter, please go ahead.
下一個問題來自法國巴黎銀行的 Peter Verdult。彼得,請繼續。
Peter Verdult - Analyst
Peter Verdult - Analyst
Peter Verdult, BNP. Just two quick ones for you, Tony, just following up from Matt's. I hear your comments about adequate US trial representation in your key programs. But just a factual question, when we checked DREAMM-10 first-line study, there are no US sites. Now I know we can't talk about Blenrep, I will respect that. But it's a factual question. Am I correct in that assumption that there are no US sites currently for DREAMM-10?
英國國家黨的彼得·維爾杜爾特(Peter Verdult)。東尼,我只想快速問你兩個問題,這是馬特的後續問題。我聽到了您關於在您的關鍵項目中美國審判代表是否有足夠的意見。但這只是事實問題,當我們檢查 DREAMM-10 一線研究時,沒有美國站點。現在我知道我們不能談論 Blenrep,我會尊重這一點。但這是一個事實問題。我是否正確地假設目前美國沒有 DREAMM-10 站點?
And then secondly, on the Hengrui deal, after PDE3/4, is there any other assets you can call out at this stage that might be entering the clinic in the next 12 to 18 months? Or do we need to be a little bit more patient? Thank you.
其次,關於恆瑞交易,在 PDE3/4 之後,目前還有其他資產可以提及,可能會在未來 12 到 18 個月內進入臨床階段嗎?或者我們需要再耐心一點?謝謝。
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
Yeah. Let me just quickly deal with DREAMM-10. You're right on clinicaltrials.gov. It doesn't show our activities to recruit US patients at this current point in time. But as I said, we have extensive studies that we're enacting that will increase US patient recruitment, not just for DREAMM-10, but more broadly across the portfolio, including the new ADCs.
是的。讓我快速處理一下 DREAMM-10。你說得對,clinicaltrials.gov 網站上沒有顯示我們目前招募美國患者的活動。但正如我所說,我們正在進行廣泛的研究,這將增加美國患者的招募,不僅針對 DREAMM-10,而且更廣泛地針對整個產品組合,包括新的 ADC。
And then sorry, secondly, remind me of the second question. Hengrui, yeah. In signing the deal, we contemplated the first four or five of potential options there is -- but I'm not going to disclose those in any more detail at this stage.
然後抱歉,其次,提醒我第二個問題。恆瑞,是啊。在簽署協議時,我們考慮了前四、五個潛在的選擇——但目前我不會透露更多細節。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
The key is they're all in areas that are core to -- the core therapy areas for expansion for us. And we'll keep you updated as we roll those through.
關鍵在於它們都處於核心領域——我們要擴展的核心治療領域。我們將隨時向您通報最新進展。
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
And some of them will then be there in the clinic next year.
其中一些人明年就會來到診所。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Definitely.
確實。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Next question comes from Rajan Sharma from Goldman Sachs. Rajan, please go ahead.
下一個問題來自高盛的 Rajan Sharma。拉詹,請繼續。
Rajan Sharma - Analyst
Rajan Sharma - Analyst
So just wanted to get an update on Blujepa's launch. So I think it was approved back in March, but it doesn't look like it's launched yet. So it would be helpful to just understand timelines there and then expectations in terms of the launch trajectory, given that you've, I think, previously guided to more than GBP2 billion peak sales for that new anti-infective's portfolio.
所以只是想了解 Blujepa 發布的最新消息。所以我認為它在三月就被批准了,但看起來還沒有推出。因此,鑑於您之前曾預測該新型抗感染藥物的峰值銷售額將超過 20 億英鎊,因此了解當時的時間表以及對發布軌蹟的預期將會很有幫助。
And then obviously, based on the commentary, it looks like R&D expenses will be higher than previous guidance. Could you just help us understand what the drivers are? It doesn't look like there's any kind of materially large new trials that are kicking off in the second half of the year and maybe a couple are rolling off. So that would be helpful there. Thank you.
然後顯然,根據評論,研發費用似乎將高於先前的預期。您能幫助我們了解一下驅動因素是什麼嗎?看起來下半年不會有任何實質的大規模新試驗啟動,也許只有幾項試驗會結束。這會很有幫助。謝謝。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Yeah. And Julie, maybe you'll do that -- we do have four big ones, big pivotals kicking off second half. And then Luke, I think, will comment on Blujepa. We did say last quarter that because of formulary timing, we're going to be a bit later with that launch. And there is a full portfolio of anti-infectives, but one we're very ambitious for a long time since anyone brought any new antibiotics. So Julie, first, and then Luke, please.
是的。朱莉,也許你會這麼做——我們確實有四個重要的、關鍵的事件在下半場開始。然後我認為盧克會對 Blujepa 進行評論。我們上個季度確實說過,由於處方時間的原因,我們的產品發表會稍晚。我們有全系列的抗感染藥物,但自從有人推出新的抗生素以來,我們一直很雄心勃勃。首先有請朱莉,然後有請盧克。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Yeah. Thank you. So the main R&D areas we sat down as a team and looked at the areas we wanted to accelerate. And clearly, one of the main areas is the ADC portfolio. I think as Tony has covered, we've got a large number of solid tumor opportunities with B7-H3, which we are looking into to accelerate considerably this year and into next year.
是的。謝謝。因此,我們作為一個團隊坐下來討論主要的研發領域,並研究我們想要加速的領域。顯然,其中一個主要領域是 ADC 產品組合。我認為正如 Tony 所說的那樣,我們在 B7-H3 方面擁有大量治療實體瘤的機會,我們正在研究今年和明年能否大幅加速這一進程。
And then as Emma mentioned, we've got four pivotals now going through, three of which are BD orientated and sourced, and one is our own. So those are the main areas. Tony, do you want to add to that?
然後,正如 Emma 所提到的,我們現在有四個關鍵點需要解決,其中三個是 BD 導向和來源的,一個是我們自己的。這些就是主要領域。東尼,你還有什麼要補充的嗎?
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
No, that's completed. It's four new Phase III studies in the ADC portfolio expansion.
不,已經完成了。這是 ADC 產品組合擴展中的四項新的 III 期研究。
Luke Miels - Chief Commercial Officer
Luke Miels - Chief Commercial Officer
Yeah. Thanks, Rajan. So as Emma said, we're talking to payers right now. Things should be more visible in Q3 with a full launch push in Q1 next year. If you just look at patients, there's around 15 million episodes of uncomplicated UTIs in the US, of which 3 million are individuals that are resistant to multiple classes or allergic to three or more antibiotics.
是的。謝謝,拉詹。正如艾瑪所說,我們現在正在與付款人交談。隨著明年第一季全面推出,第三季的情況應該會更加明朗。如果只看患者,美國約有 1500 萬例無併發症泌尿道感染,其中 300 萬人對多種抗生素有抗藥性或對三種或三種以上抗生素過敏。
That's the targeting population that we've got there. We just wanted to do a little bit more work on the pricing. And also, we've had positive Phase III results with tebipenem, which I think is also very attractive initially in complicated UTI patients who typically are admitted for ceftriaxone treatment. So this is the option of keeping those patients off the pump, keep them at home with patient benefits as well as cost benefits in the US healthcare system.
這就是我們的目標群。我們只是想在定價方面做更多的工作。此外,我們在替比培南的 III 期臨床試驗中取得了積極的成果,我認為這對於通常接受頭孢曲松治療的複雜性泌尿道感染患者來說也非常有吸引力。因此,這是讓這些患者遠離幫浦、讓他們留在家中並享受美國醫療保健系統帶來的患者福利和成本效益的選擇。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Yeah. And another trial stop for efficacy there. So excited to see what comes on further.
是的。並在那裡進行了另一次試驗以驗證其療效。非常興奮地想看看接下來會發生什麼事。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
The next question comes from Steve Scala from Cowen. Go ahead, Steve.
下一個問題來自 Cowen 的 Steve Scala。繼續吧,史蒂夫。
Steve Scala - Analyst
Steve Scala - Analyst
A few questions. First, I'm curious about trends of Shingrix in China through the distributor. Are things improving, getting worse or somewhat -- or somewhere between? Yesterday, Merck implied that there were no signs of improvement for Gardasil and issues could extend to 2026. Is the same true for Shingrix?
幾個問題。首先,我很好奇 Shingrix 透過經銷商在中國的發展趨勢。情況是在改善、惡化還是有所改善——或者介於兩者之間?昨天,默克公司暗示,Gardasil 疫苗沒有改善的跡象,問題可能會延續到 2026 年。Shingrix 也是同樣的情況嗎?
Secondly, can we have an update on the pneumococcal vaccine program? Will you initiate Phase III in the 30-valent vaccine in adults? When do you intend to do that? Secondly, have you addressed the manufacturing issues for the pediatric vaccine? And when does GSK expect data readout for the 24-valent in infants?
其次,我們能否了解肺炎鏈球菌疫苗計畫的最新進展?您會啟動成人 30 價疫苗的 III 期臨床試驗嗎?你打算什麼時候做這件事?其次,您是否解決了兒童疫苗的生產問題?葛蘭素史克預計何時能獲得嬰兒 24 價抗體的數據讀數?
And then lastly, apologies, Blenrep. Does the recent FDA CBER leadership change alter the outlook in any way? The proximity of the news is quite curious. Thank you.
最後,Blenrep,抱歉。FDA CBER 領導層最近的變動是否會改變前景?這則訊息的臨近令人十分好奇。謝謝。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
So on the last one, there's no read across from that. And let's go to Luke, please, first on Shingrix in China, and then Tony on update on pneumococcal.
所以對於最後一個,沒有任何解讀。首先請盧克介紹中國的 Shingrix 情況,然後請托尼介紹一下肺炎球菌的最新情況。
Luke Miels - Chief Commercial Officer
Luke Miels - Chief Commercial Officer
Thanks, Steve. Look, the answer is, look, it's still challenging for all the reasons we explained in quarter three of 2024. However, there are some small -- they're very small green shoots. So if you look at in-market sales CDC, so market sales to CDC from Zhifei and the movement from CDC to the points of vaccination, there is a trend upwards for the last -- yes, three months, from memory. But it's off a very low base, so heavy caution there.
謝謝,史蒂夫。看,答案是,看,由於我們在 2024 年第三季解釋的所有原因,它仍然具有挑戰性。然而,也有一些很小的——非常小的綠芽。因此,如果您查看 CDC 的市場銷售情況,那麼從智飛到 CDC 的市場銷售情況以及從 CDC 到疫苗接種點的流動情況,就會發現過去三個月呈上升趨勢——是的,從記憶中看。但其基礎非常低,因此需要格外謹慎。
The other thing is the CDC stock levels are declining, and they've been declining since about February of this year. So it's not enough for us to trigger a major shipment to Zhifei, but it is -- it's at least pointing in the right direction.
另一件事是 CDC 的庫存水準正在下降,自今年 2 月左右以來一直在下降。因此,這還不足以促使我們向志飛進行大規模發貨,但它至少指向了正確的方向。
The other point I'd make is, look, we've done a lot of work on the strategy on the way forward here. It's very clear, and we've got good alignment with Zhifei. And it's a focus on the comorbid chronic disease subpopulation, who are clearly higher risk. We seem to get better traction there. The competition has pulled back, which has created a bit of room for us, and we've actually increased our share of voice to take advantage of that. All the other parameters like ATP perception, patient perception are pretty stable.
我想說的另一點是,你看,我們在前進的策略上做了很多工作。非常清楚,我們與志飛的合作非常順利。重點關注的是合併慢性病的亞群,他們顯然有更高的風險。我們似乎在那裡獲得了更好的進展。競爭對手已經退出,這為我們創造了一些空間,我們實際上已經增加了自己的話語權以利用這一點。所有其他參數,如 ATP 感知、患者感知都相當穩定。
So again, I won't say anything about '26, but I would say we remain confident of the mid- to longer-term opportunity in China, and we just need to stick at it. And finally, we're also doing some life cycle, Tony mentioned this before, in terms of a dementia experiment within China itself. So yeah, we'll keep moving forward.
所以,我不會談論26年,但我想說,我們仍然對中國的中長期機會充滿信心,我們只需要堅持下去。最後,我們還在做一些生命週期研究,Tony 之前提到過,就中國國內的癡呆症實驗而言。是的,我們會繼續前進。
Tony Wood - Chief Scientific Officer, Head - R&D
Tony Wood - Chief Scientific Officer, Head - R&D
Great. And then just quickly on MAPS, Steve. As far as the 24-valent platforms are concerned, both in adults and infants, we've learned enough from those platforms to move now to strategically prioritize the 30-plus vaccine. We feel that the characteristics of the MAPS platform are better expressed there. And I'm sure you'll follow that the field in general is going in that direction and sort of more tailored approach is also encountering some issues associated with, with concerns with regards to the evolution of new serotypes like serotype 4.
偉大的。然後快速介紹一下 MAPS,史蒂夫。就成人和嬰兒的 24 價平台而言,我們已經從這些平台中學到了很多東西,現在可以策略性地優先考慮 30 多種疫苗。我們覺得MAPS平台的特色在那裡得到了更好的體現。我相信您會注意到,該領域總體上正朝著這個方向發展,某種更有針對性的方法也遇到了一些問題,這些問題與新血清型(如血清型 4)的演變有關。
We are on track with regards to starting our first-in-human for a 30-plus vaccine study at the end of this year. So you should expect readouts on that really in the first half of 2026. I'd say when you consider the progress we're making with regards to the 30-plus format and the competitive environment, we remain very much on track and competitive with the 30-plus vaccine, but that, of course, will be towards the end of the decade.
我們計劃在今年底啟動一項針對 30 多種疫苗的首次人體試驗。因此,您應該會在 2026 年上半年真正看到相關數據。我想說,當你考慮到我們在 30 多種形式和競爭環境方面取得的進展時,我們在 30 多種疫苗方面仍然保持著良好的競爭力,但這當然要到本世紀末。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Great. Thank you. I think we have one more question.
偉大的。謝謝。我想我們還有一個問題。
Constantin Fest - Head - Investor Relations
Constantin Fest - Head - Investor Relations
Yes. Time for one last short question. Justin Smith, please from Bernstein. Please go ahead. I think you should be able to speak, Justin.
是的。現在是最後一個簡短的問題了。請伯恩斯坦的賈斯汀·史密斯發言。請繼續。我認為你應該可以說話了,賈斯汀。
Okay. That's not working, then we can also call.
好的。那不行的話我們還可以打電話。
Emma Walmsley - Chief Executive Officer, Executive Director
Emma Walmsley - Chief Executive Officer, Executive Director
Okay. Well, listen, thanks very much, everyone, for joining. Delighted to be reporting another strong quarter, and this consists -- delivery of the consistent step-up of GSK since the separation and most excitingly, the R&D progress we continue to deliver.
好的。好吧,聽著,非常感謝大家的參與。很高興能夠報告另一個強勁的季度,這包括——自分離以來葛蘭素史克的持續提升,以及最令人興奮的是我們繼續取得的研發進展。
We're pleased to update our guidance for the year to being at the top end of the range and continue to be highly confident together of our, not only our short, but our medium and our long-term outlooks. Look forward to talking to you over the coming days. Thanks. Bye.
我們很高興將今年的業績預期更新至最高水平,並且繼續對我們的短期、中期和長期前景充滿信心。期待未來幾天與您交談。謝謝。再見。