葛蘭素史克 (GSK) 2023 Q3 法說會逐字稿

內容摘要

葛蘭素史克公佈了強勁的季度業績,銷售額和利潤均實現兩位數增長。他們的 RSV 疫苗 Arexvy 的成功促成了強勁的業績,導致 2023 年銷售額、營業利潤和每股收益指導上調。

該公司對疫苗和特殊藥物的預防和投資取得了成功,新產品促進了銷售成長。該公司還強調了對 ESG 優先事項的承諾,並討論了傳染病、愛滋病毒和腫瘤學方面的進展。

第三季度,該公司在所有地區的疫苗和專科藥物均實現成長,其中 Arexvy 和 Shingrix 表現強勁。該公司預計今年將實現低至中個位數的成長。在患者需求以及口服兩種藥物療法和長效注射劑的成功推動下,愛滋病毒業務實現了強勁的銷售成長。該公司對實現銷售成長並維持愛滋病毒領域的創新領先地位充滿信心。

葛蘭素史克在其路線圖上取得了重大進展,並升級了全年指導。該公司強調其對管道投資的重點,並對未來的雄心抱有信心。演講者還討論了有關乙肝病毒的協議以及功能性治癒的可能性。

葛蘭素史克(GSK)解決了有關取消醫療補助上限和潛在標籤變化的影響的問題。他們也討論了 Arexvy 和 Jemperli 的潛力以及 Jemperli 的競爭地位。該公司討論了其免疫產品的成功以及防止貨架空置和競爭的計劃。他們表達了擊敗競爭對手的信心,並討論了 Shingrix 及其 mRNA 平台的成功。

該公司對其疫苗管道、愛滋病毒和呼吸系統產品的未來前景持樂觀態度。

完整原文

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

  • Nick Stone

    Nick Stone

  • Hello everyone, it's Nick Stone, Head of Investor Relations. Welcome to our year-to-date and Q3, 2023 results conference call and webcast for investors and analysts.

    大家好,我是投資人關係主管尼克‧史東。歡迎參加我們為投資者和分析師舉辦的年初至今和 2023 年第三季業績電話會議和網路廣播。

  • The presentation was sent out to our distribution list by e-mail, and you can also find this on GSK.com. Please turn to Slide 2.

    該簡報已透過電子郵件發送到我們的分發列表,您也可以在 GSK.com 上找到該簡報。請翻到投影片 2。

  • This is the usual safe harbor statements, we'll comment on our performance using constant exchange rates, or CER unless stated otherwise. As a reminder, the following the Consumer Healthcare demerger in 2022 to form Haleon, representing performance and growth of the continuing operations for GSK. Please turn to Slide 3. Today's call will last approximately 1 hour, with the management presentation taking around 30 minutes, and the remaining time for your questions. (Operator Instructions)

    這是通常的安全港聲明,除非另有說明,否則我們將使用固定匯率或 CER 來評論我們的業績。提醒一下,繼消費者保健業務於 2022 年分拆成立 Haleon 後,這代表了葛蘭素史克持續營運業務的業績和成長。請看投影片 3。今天的電話會議將持續約 1 小時,其中管理層演示大約需要 30 分鐘,剩下的時間是提問。 (操作員說明)

  • Our speakers are Emma Walmsley, Tony Wood, Luke Miels, Deborah Waterhouse and Julie Brown, with David Redford joining the rest of the team for the Q&A portion of the call.

    我們的演講者包括艾瑪·沃姆斯利(Emma Walmsley)、托尼·伍德(Tony Wood)、盧克·米爾斯(Luke Miels)、黛博拉·沃特豪斯(Deborah Waterhouse) 和朱莉布朗(Julie Brown),大衛雷德福(David Redford) 也加入了團隊的其他成員,參與了電話會議的問答部分。

  • I'll now hand the call over to Emma.

    我現在把電話轉給艾瑪。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Nick, and welcome to everybody joining us today. I am delighted to be presenting to you all with another set of excellent quarterly results. Please turn to the next slide.

    謝謝尼克,歡迎大家今天加入我們。我很高興向大家展示另一組出色的季度業績。請翻到下一張投影片。

  • Sales and profits grew double-digits for the quarter, with sales up 16% to GBP 8.1 billion. Adjusted operating profit up 22% to GBP 2.8 billion. And adjusted earnings per share up 25% to GBP 50.4p, all excluding Pandemic solutions.

    本季銷售額和利潤均實現兩位數成長,銷售額成長 16% 至 81 億英鎊。調整後營業利潤成長 22%,達到 28 億英鎊。調整後每股收益成長 25%,達到 50.4 便士,全部不包括流行病解決方案。

  • Our strong performance was broadly based and benefited particularly from the outstanding U.S. launch of our RSV vaccine, Arexvy, on track to be a blockbuster in its first year on the market. This excellent execution, together with our drive for efficiency and margin accretion means we can upgrade our 2023 sales, adjusted operating profit and adjusted EPS guidance.

    我們的強勁表現具有廣泛的基礎,尤其受益於我們在美國推出的 RSV 疫苗 Arexvy,該疫苗預計將在上市第一年成為重磅炸彈。這種出色的執行力,加上我們對效率和利潤成長的追求,意味著我們可以提高 2023 年的銷售額、調整後的營業利潤和調整後的每股盈餘指引。

  • For the year, we now expect sales to increase between 12% and 13%, adjusted operating profit to increase between 13% and 15%, and adjusted EPS to increase between 17% and 20%.

    我們目前預計今年銷售額將成長 12% 至 13%,調整後營業利潤將成長 13% 至 15%,調整後每股盈餘將成長 17% 至 20%。

  • Within sales, we are upgrading the outlooks across all segments for the year, reflecting our clear momentum. Our performance also clearly demonstrates delivery of the strategic choices we've made to invest in prevention as well as the treatment of disease.

    在銷售方面,我們正在上調今年所有細分市場的前景,反映出我們的明顯動能。我們的表現也清楚地表明了我們為投資預防和治療疾病所做的策略選擇。

  • New products launched since 2017 have contributed sales of GBP 7.8 billion so far this year, with nearly 80% of them coming from vaccines and specialty medicines.

    2017年以來推出的新產品今年迄今已貢獻78億英鎊的銷售額,其中近80%來自疫苗和專科藥物。

  • Approvals this year for Arexvy and Apretude, together with 2 important oncology medicines, Jemperli, and most recently, Ojjaara, further strengthened this new product portfolio and other meaningful sources of profitable growth.

    今年批准的 Arexvy 和 Apretude 以及兩種重要的腫瘤藥物 Jemperli 和最近的 Ojjaara 進一步加強了這個新產品組合和其他有意義的利潤成長來源。

  • So taken all together, this is a strong and sustained performance heading into 2024. Next slide, please.

    總而言之,這是進入 2024 年的強勁且持續的表現。請看下一張投影片。

  • This quarter further underscore the importance and strength of our vaccines business. Prevention is an increasing focus for health care systems all around the world. GSK is a world leader in vaccines and is extremely well placed to deliver innovation and offer value to both individuals and payers.

    本季進一步凸顯了我們疫苗業務的重要性和實力。預防越來越受到世界各地醫療保健系統的關注。葛蘭素史克 (GSK) 是疫苗領域的全球領導者,在提供創新並為個人和付款人提供價值方面處於非常有利的地位。

  • The introduction of Arexvy in the U.S. is evidence of this, demonstrating our strong launch capabilities, with over GBP 700 million of sales in its very first quarter as we protect people at scale, from this life-threatening disease and especially those with comorbidities.

    Arexvy 在美國的推出證明了這一點,展示了我們強大的上市能力,第一季的銷售額就超過7 億英鎊,因為我們大規模地保護人們免受這種危及生命的疾病,特別是患有合併症的疾病的侵害。

  • Generating further clinical evidence for Arexvy remains a clear priority, and we were pleased to present positive data in adults aged 50 to 59 years at the CDC's Advisory Committee on Immunization Practices last month.

    為 Arexvy 提供進一步的臨床證據仍然是一個明確的優先事項,我們很高興上個月在 CDC 免疫實踐諮詢委員會上展示了 50 至 59 歲成年人的積極數據。

  • We also added to the outstanding clinical profile of the Shingrix this quarter. Results of a large post marketing study in China, demonstrating 100% efficacy. And alongside this, we're additionally significantly expanding availability of Shingrix in China. Our exclusive partnership with Zhifei signed last month is going to support and accelerate our goal with Shingrix annual sales of more than GBP 4 billion by 2026, and with opportunities to expand this partnership further, including potentially with Arexvy.

    本季我們也增加了 Shingrix 出色的臨床表現。中國一項大型上市後研究結果顯示 100% 有效。除此之外,我們也大幅擴大 Shingrix 在中國的可用性。我們上個月與智飛簽署的獨家合作夥伴關係將支持和加速我們的目標,即到2026 年Shingrix 年銷售額超過40 億英鎊,並有機會進一步擴大這種合作夥伴關係,包括可能與Arexvy 合作。

  • Our innovation in RSV, shingles, meningitis and pediatrics all demonstrate our world's leading vaccines capabilities. And we have further substantial innovation in the pipeline where we have our comprehensive and leading suite of vaccine platform technologies, including next-generation mRNA, our multiple antigen presenting system or MAPS, as well as, of course, as our adjuvant systems.

    我們在呼吸道合胞病毒、帶狀皰疹、腦膜炎和兒科領域的創新都展示了我們世界領先的疫苗能力。我們在管道中還有進一步的實質創新,我們擁有全面且領先的疫苗平台技術套件,包括下一代 mRNA、我們的多抗原呈現系統或 MAPS,當然還有我們的佐劑系統。

  • All of these offer exciting new opportunities in seasonal respiratory bacterial and chronic viral infections, and we continue to explore the science beyond infectious diseases. Next slide, please.

    所有這些都為季節性呼吸道細菌和慢性病毒感染提供了令人興奮的新機會,我們將繼續探索傳染病以外的科學。請下一張投影片。

  • Alongside delivering stronger shareholder returns, we also continue to build trust by delivering across the 6 key areas we prioritized for ESG. This quarter, I'm highlighting our continued commitment to fight malaria with innovation. GSK scientists, working with Johns Hopkins Institute and others, published their groundbreaking discovery in the naturally occurring bacteria and that can significantly reduce the malaria parasite [load] in mosquitoes, indicating the potential to inhibit transmission of malaria to humans.

    除了提供更強勁的股東回報外,我們還透過在 ESG 優先考慮的 6 個關鍵領域繼續建立信任。本季度,我將強調我們持續致力於透過創新對抗瘧疾。葛蘭素史克的科學家與約翰霍普金斯研究所等機構合作,發表了他們在自然細菌中的突破性發現,該發現可以顯著減少蚊子體內的瘧疾寄生蟲,表明有可能抑制瘧疾向人類傳播。

  • And we also continue to deliver our environment and diversity, equity and inclusion goals. Further details, along with more on all 6 key areas, are included in the Q3 results announcement.

    我們也繼續實現我們的環境和多元化、公平和包容性目標。更多詳細資訊以及所有 6 個關鍵領域的更多資訊均包含在第三季業績公告中。

  • Now, let's hear more from the team on our progress, starting with Tony and R&D.

    現在,讓我們從托尼和研發部開始,聽聽團隊關於我們進展的更多資訊。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Thank you, Emma. My priority is investing in our pipeline and accelerating R&D to deliver new vaccines and medicines to patients.

    謝謝你,艾瑪。我的首要任務是投資我們的產品線並加速研發,為患者提供新的疫苗和藥物。

  • Today, the pipeline comprises 67 assets in clinical development, 2/3 disease prevent and treat infectious diseases and HIV.

    如今,該管道包括 67 個臨床開發資產,2/3 疾病預防和治療傳染病和愛滋病毒。

  • During the quarter, we've seen continued progress. In infectious diseases, we're focused on seasonal respiratory viruses, bacterial, fungal and chronic viral infections. In seasonal respiratory viruses, Arexvy received approval in Japan as the country's first RSV vaccine for older adults.

    在本季度,我們看到了持續的進展。在傳染病方面,我們專注於季節性呼吸道病毒、細菌、真菌和慢性病毒感染。在季節性呼吸道病毒方面,Arexvy 在日本獲得批准,成為全國首個針對老年人的 RSV 疫苗。

  • And we also shared positive data for 50 to 59 year olds, with the advisory committee on immunization practices in the U.S. In chronic viral infections, we will present data later this month on bepirovirsen, a potentially transforming treatment for chronic hepatitis B. I'll talk more about these data shortly.

    我們還與美國免疫實踐諮詢委員會分享了50 至59 歲人群的積極數據。在慢性病毒感染方面,我們將在本月晚些時候提供貝匹羅韋森的數據,貝匹羅韋森是一種潛在的慢性乙型肝炎治療方法。我將稍後詳細討論這些數據。

  • In HIV, the European Medicines Agency approved Apretude as the first and only HIV prevention option in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in high-risk adults and adolescents.

    在愛滋病毒方面,歐洲藥品管理局批准 Apretude 作為第一個也是唯一一個與安全性行為相結合的愛滋病毒預防選擇,以降低高風險成人和青少年透過性行為獲得愛滋病毒感染的風險。

  • For respiratory, Japan accepted the regulatory submission of Nucala for chronic rhinosinusitis with nasal polyps. And later this month, alongside Luke, I look forward to providing you with insights into our respiratory strategy and medicines at the next focus to meet the management event.

    在呼吸系統方面,日本接受了 Nucala 治療慢性鼻竇炎伴鼻息肉的監管申請。本月晚些時候,我期待與盧克一起在下一個焦點會議上為您提供有關我們的呼吸策略和藥物的見解,以應對管理活動。

  • For oncology, the European Medicines Agency recommended not renewing conditional marketing authorization for Blenrep. As a reminder, given the changing regulatory environment, our expectation to remain low for the event-driven DREAMM-7 and DREAMM-8 Phase III trials. We now expect to read these out in 2024.

    對於腫瘤學,歐洲藥品管理局建議不要續簽 Blenrep 的有條件行銷授權。提醒一下,鑑於監管環境不斷變化,我們對事件驅動的 DREAMM-7 和 DREAMM-8 III 期試驗的期望仍然較低。我們現在預計將在 2024 年宣讀這些內容。

  • This quarter, we also reached an exclusive licensing agreement with Hansoh for a Phase I B7-H4 targeted antibody-drug conjugate or ADC. We believe this has best class potential in ovarian and endometrial cancer with opportunities in other solid tumors.

    本季度,我們也與豪森達成了 I 期 B7-H4 標靶抗體藥物偶聯物或 ADC 的獨家授權協議。我們相信這在卵巢癌和子宮內膜癌中具有最佳潛力,並且在其他實體瘤中也有機會。

  • Lastly, we are delighted with the U.S. FDA approval of Ojjaara or momelotinib, which is indicated for treating myelofibrosis in adults with anemia. And the approval of Jemperli, our highly effective PD-1 inhibitor, as the first new frontline treatment for patients with dMMR/MSI-H, primary advanced or recurrent endometrial cancer.

    最後,我們很高興美國 FDA 批准 Ojjaara 或 momelotinib,用於治療成人貧血患者的骨髓纖維化。我們的高效 PD-1 抑制劑 Jemperli 被批准為 dMMR/MSI-H、原發性晚期或復發性子宮內膜癌患者的首個新一線治療藥物。

  • The profile with for Jemperli was strengthened by the recent interim analysis of RUBY [Part 1], which reported a statistically significant and clinically meaningful survival benefit in the overall population enrolled. We aim to present these OS data at a conference early next year. Next slide, please.

    最近對 RUBY [第 1 部分] 的中期分析進一步強化了 Jemperli 的概況,該分析報告了在總體入組人群中具有統計意義和臨床意義的生存獲益。我們的目標是在明年初的一次會議上展示這些作業系統數據。請下一張投影片。

  • Last week, we presented further safety and immunogenicity data for Arexvy to ACIP. The vaccine met its co-primary endpoints and demonstrated non-inferiority in people aged 50 to 59 years of age when compared with adults of 60 years and older, including those at increased risk of RSV lower respiratory tract disease.

    上週,我們向 ACIP 提供了 Arexvy 的進一步安全性和免疫原性數據。該疫苗達到了其共同主要終點,與 60 歲及以上的成年人(包括那些 RSV 下呼吸道疾病風險較高的人)相比,在 50 至 59 歲的人群中表現出非劣效性。

  • These data continue to demonstrate the consistent strength of Arexvy profile in protecting the most vulnerable. We will make a supplementary biological license application to the U.S. FDA before the end of this year, in time for next year's ACIP to further support potential label updates.

    這些數據繼續證明了 Arexvy 配置文件在保護最弱勢群體方面的一貫實力。我們將在今年年底前向美國 FDA 提出補充生物許可申請,​​以便趕在明年的 ACIP 之前進一步支持潛在的標籤更新。

  • For Shingrix, we continue to build our knowledge with new data, demonstrating 100% efficacy in the prevention of shingles in China for adults aged 50 and over, a remarkable result. We expect to publish these data in a peer-reviewed scientific journal before the end of the year. Slide 11, please.

    對於Shingrix來說,我們不斷用新的數據來累積我們的知識,證明在中國50歲及以上的成年人預防帶狀皰疹方面有100%的功效,這是一個了不起的成果。我們預計在今年年底前在同行評審的科學期刊上發布這些數據。請投影片 11。

  • Continuing with infectious diseases, bepirovirsen, our triple-action antisense oligonucleotide has the potential to be the cornerstone of functional cure for patients with chronic hepatitis B. It inhibits viral replication, reducing viral DNA, and thus the production of viral proteins, including the hepatitis B surface antigen. And importantly, it stimulates the body's innate immune system.

    繼續針對傳染病,貝匹羅韋森,我們的三效反義寡核苷酸有可能成為慢性乙型肝炎患者功能性治癒的基石。它抑制病毒複製,減少病毒DNA,從而產生病毒蛋白,包括肝炎病毒蛋白B表面抗原。重要的是,它可以刺激人體的先天免疫系統。

  • We believe this triple mechanism of action is the reason for bepirovirsen's unique profile.

    我們相信,這種三重作用機制是貝匹羅韋森具有獨特特徵的原因。

  • There are more than 300 million people living with hepatitis B, and our goal is to provide patients with the first clinically meaningful functional cure for hepatitis B, eliminating the need for continued therapy and ultimately reducing the long-term risk of developing liver cirrhosis and cancer.

    有超過 3 億乙型肝炎患者,我們的目標是為患者提供第一個有臨床意義的乙型肝炎功能性治癒方法,消除繼續治療的需要,最終降低肝硬化和癌症的長期風險。

  • We now have 2 completed Phase II trials, for which data are consistent, and demonstrate the patients with low surface antigen have the greatest chance of a functional cure when treated with bepi. In the case of B-Together, this has not significantly improved by sequential Peg-interferon treatment.

    我們現在有 2 項已完成的 II 期試驗,其數據是一致的,並證明低表面抗原的患者在接受 Bepi 治療時獲得功能性治癒的機會最大。就 B-Together 而言,連續聚乙二醇幹擾素治療並未顯著改善此情況。

  • However, the recent exclusive license of Janssen's Phase II small interfering RNA-based therapeutic provides a complementary opportunity to develop a potential novel sequential regimen to benefit a broader patient population and potentially drive higher functional cure rates.

    然而,楊森最近獲得的II 期小幹擾RNA 療法的獨家許可提供了一個補充機會,可以開發一種潛在的新型序貫治療方案,使更廣泛的患者群體受益,並有可能推動更高的功能治愈率。

  • Lastly, we hope data from B-Sure will be presented later this month at AASLD. This will demonstrate a durable response for a significant proportion of patients treated with bepi.

    最後,我們希望 B-Sure 的數據將於本月稍後在 AASLD 上公佈。這將證明大部分接受 bepi 治療的患者俱有持久的反應。

  • Our Phase III trials, B-Well 1 and B-Well 2 are progressing as planned in 31 countries, with data anticipated in 2025.

    我們的 III 期試驗 B-Well 1 和 B-Well 2 正在 31 個國家按計劃進行,預計將於 2025 年提供數據。

  • Turning to my final slide. This slide highlights important clinical data readouts and regulatory events over the upcoming months. You can find a comprehensive overview in the appendix.

    轉向我的最後一張投影片。這張投影片重點介紹了未來幾個月的重要臨床數據讀數和監管事件。您可以在附錄中找到全面的概述。

  • In summary, I'm pleased with our progress so far this year. We have clear plans to move forward at pace, deliver on our key objectives for R&D and support GSK's overall growth ambitions. I'll now hand it over to Luke on Slide 13.

    總而言之,我對今年迄今的進展感到滿意。我們有明確的計劃來快速推進,實現我們的關鍵研發目標並支持葛蘭素史克的整體成長目標。我現在將投影片 13 上的內容交給 Luke。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Thanks, Tony. In Q3, we again delivered growth across vaccines and specialty medicines in each region with GBP 8.1 billion of sales, up 16% versus last year, excluding pandemic solutions. Please turn to Slide 15.

    謝謝,托尼。第三季度,我們在每個地區的疫苗和特種藥物領域再次成長,銷售額達 81 億英鎊,比去年成長 16%(不包括流行病解決方案)。請翻到投影片 15。

  • In Vaccines, we saw strong growth of 34% in the quarter, excluding Pandemic Solutions, led by the excellent launch of Arexvy which contributed GBP 709 million.

    在疫苗領域,本季我們看到了 34% 的強勁成長(不包括流行病解決方案),其中以 Arexvy 的出色推出為首,貢獻了 7.09 億英鎊。

  • On the same basis, we now expect full year vaccine sales growth to be around 20%.

    基於同樣的基礎,我們現在預計全年疫苗銷售成長將在 20% 左右。

  • On Arexvy, I want to highlight the excitement our organization has had behind the launch that we've seen in the U.S. Following an initial inventory build, we saw high demand and received 2 out of every 3 retail prescriptions.

    關於 Arexvy,我想強調我們的組織在美國推出這款產品後所感到的興奮。在最初的庫存建立之後,我們看到了很高的需求,每 3 個零售處方中就有 2 個收到。

  • In the quarter, we saw around 50% of Arexvy doses were co-administered with flu, and we're pleased with our commercial positioning in all major pharmacies, including competitive contracts with 11 key accounts. We strategically chose to highlight our 94.6% efficacy in the comorbid population, and that message seems to resonate well with strong HCP brand recognition.

    在本季度,我們看到大約 50% 的 Arexvy 劑量與流感同時服用,我們對我們在所有主要藥房的商業定位感到滿意,包括與 11 個關鍵客戶的競爭性合約。我們策略性地選擇強調我們對共病族群的 94.6% 有效率,而這訊息似乎與強大的 HCP 品牌認知度產生了很好的共鳴。

  • There's a long runway for Arexvy in the U.S., where during the quarter, we've vaccinated more than 1.4 million adults of the 83 million at risk, and ex U.S. as launches are underway across Europe and Canada.

    Arexvy 在美國還有很長的路要走,在本季度,我們已經為 8,300 萬高風險族群中的超過 140 萬名成年人接種了疫苗,除美國外,歐洲和加拿大的疫苗接種工作正在進行中。

  • In September, we also received approval in Japan.

    9月份,我們在日本也獲得了批准。

  • We remain confident in our peak sales being greater than GBP 3 billion. For the full year, we expect sales to be between GBP 0.9 million and GBP 1 billion based on an analog of flu vaccination seasonality. However, there continue to be unknown factors, including annual vaccination patents, formulational projection and what revaccination recommendations might be. We will continue to keep you informed, of course, as we learn more. Next slide, please.

    我們對高峰銷售額超過 30 億英鎊仍然充滿信心。根據流感疫苗接種季節性的模擬,我們預計全年銷售額將在 90 萬英鎊至 10 億英鎊之間。然而,仍有未知因素,包括年度疫苗接種專利、配方預測以及可能的重新疫苗接種建議。當然,隨著我們了解更多信息,我們將繼續向您通報情況。請下一張投影片。

  • Moving to Shingrix. This remains an important vaccine for our portfolio, up 15% versus last year, with the ex U.S. contribution, now representing 50% of sales.

    搬到欣格里克斯。這仍然是我們產品組合中的重要疫苗,與去年相比成長了 15%,其中美國以外的貢獻目前佔銷售額的 50%。

  • In addition to the U.S., Shingrix is available at 38 additional countries, with less than 3% penetration in most markets, and we continue to have unconstrained supply.

    除美國外,Shingrix 還在另外 38 個國家/地區上市,在大多數市場的滲透率不到 3%,我們將繼續提供不受限制的供應。

  • In the U.S., we've reached the most motivated consumers with 33% penetration of more than 120 million adults recommended to receive Shingrix. We remain encouraged by the growth in retail, which was up 4% in the quarter, and are investing in strategic initiatives to actively target consumers and ACPs to access the next tranche of customers.

    在美國,我們已經涵蓋了最積極的消費者,在超過 1.2 億成年人中,有 33% 的人建議接受 Shingrix。我們仍然對零售業的成長感到鼓舞,本季零售業成長了 4%,並且正在投資策略性舉措,以積極瞄準消費者和 ACP,以獲得下一批客戶。

  • In October, we announced a deal with Zhifei to copromote Shingrix in China, and this partnership materially expands the number of Chinese adults who can benefit from Shingrix over the next 3 years through a company with a track record of driving access to innovative medicines and vaccines in China.

    10 月,我們宣布與智飛達成協議,在中國共同推廣Shingrix,這項合作關係透過一家在推動獲得創新藥物和疫苗方面擁有良好記錄的公司,在未來3 年內大大增加了可以從Shingrix 中受益的中國成年人數量在中國。

  • Zhifei has a significant reach across China with an extensive service network, covering more than 30,000 points of vaccination versus the current 9,500 we have now. As Emma mentioned, we expect this partnership to support and accelerate our expectations for Shingrix sales to reach more than GBP 4 billion by 2026. Next slide, please.

    智飛在中國擁有廣泛的服務網絡,覆蓋超過 30,000 個疫苗接種點,而目前我們有 9,500 個疫苗接種點。正如 Emma 所提到的,我們預計這種合作關係將支持並加速我們對 Shingrix 銷售額到 2026 年達到超過 40 億英鎊的預期。請看下一張幻燈片。

  • In specialty medicines, including HIV, which Deborah will cover shortly, we've increased our sales by 17%, excluding (inaudible). For the full year, we now expect low double-digit sales growth.

    在特殊藥物方面,包括黛博拉很快就會涵蓋的 HIV 藥物,我們的銷售額增加了 17%(不包括(聽不清楚))。對於全年,我們現在預計銷售額將實現兩位數的低成長。

  • Our market-leading medicines, Benlysta and Nucala continues to deliver double-digit growth. Benlysta was up 20% in the quarter, with growth across all major markets and a promising opportunity with updated [ULI] guidelines now recommending use earlier as part of a standard of care for lupus and lupus [erythematosus].

    我們市場領先的藥物 Benlysta 和 Nucala 繼續實現兩位數的成長。 Benlysta 在本季度上漲了 20%,所有主要市場都有成長,而更新的 [ULI] 指南現在建議儘早使用作為狼瘡和狼瘡 [紅斑狼瘡] 護理標準的一部分,這是一個充滿希望的機會。

  • Nucala is up 19% in the quarter and remains the first and only biologic approved in 4 eosinophilic diseases. We expect to see COPD data for Nucala in the second half of next year. Both of these medicines continue to have room to grow with relatively low buyer penetration and life cycle opportunities underscoring our confidence in the long-term opportunity for both.

    Nucala 在本季上漲了 19%,仍然是第一個也是唯一一個被批准用於 4 種嗜酸性粒細胞疾病的生物製劑。我們預計明年下半年將看到努卡拉的慢性阻塞性肺病數據。這兩種藥物繼續有成長空間,買家滲透率和生命週期機會相對較低,這突顯了我們對這兩種藥物的長期機會的信心。

  • In oncology, sales were up 26% in the quarter, with Jemperli now being used in the first line for appropriate endometrial cancer patients. And Zejula is up 22% due to stocking of our new tablet formulation, providing an improved patient experience. We expect this stock will be utilized by the end of the year.

    在腫瘤學領域,本季銷售額成長了 26%,Jemperli 目前被用於第一線治療合適的子宮內膜癌患者。 Zejula 的股價上漲了 22%,這得益於我們新片劑配方的庫存,改善了患者體驗。我們預計該庫存將在今年底前使用完畢。

  • And on this slide, I wanted to highlight the recent approval of our myelofibrosis medicine, Ojjaara, in addition to a line-agnostic label in the U.S., regulators acknowledge our unique benefit in anemia, an especially important characteristic for these patients. As we know that anemia status and requirements of transfusion directly correlate with poor survival prognosis and quality of life. And as you can see on this chart, if you have myelofibrosis, patient with no anemia, you have a median 8-year life expectancy. Conversely, you have a 2-year life expectancy if you're severely anemic. So for example, your hemoglobin level is below 8.

    在這張幻燈片上,我想強調我們的骨髓纖維化藥物Ojjaara 最近獲得批准,除了在美國的產品線不可知標籤外,監管機構還承認我們在貧血方面的獨特益處,這對這些患者來說是一個特別重要的特徵。我們知道,貧血​​狀況和輸血需求與不良的生存預後和生活品質直接相關。正如您在此圖表中所看到的,如果您患有骨髓纖維化且沒有貧血,您的平均壽命為 8 年。相反,如果您患有嚴重貧血,您的預期壽命只有 2 年。例如,您的血紅素水平低於 8。

  • We look forward to making this medicine available to patients and have already recorded sales in September. And with these updates, we're raising our full year oncology sales expectations to increase to low single digit. Please turn to Slide 18.

    我們期待將這種藥物提供給患者,並且已經在 9 月實現了銷售記錄。透過這些更新,我們將全年腫瘤銷售預期提高至低個位數。請翻到幻燈片 18。

  • Finally, our General Medicines portfolio continues to contribute more than GBP 2 billion in the quarter, led by Trelegy, which was up 23%. Trelegy is the fastest-growing triple therapy for COPD and asthma, with room to grow as the SITT class still only has 28% penetration of the COPD patient class share in the U.S.

    最後,我們的普通藥品組合在本季繼續貢獻超過 20 億英鎊,其中 Trelegy 成長了 23%。 Trelegy 是成長最快的 COPD 和氣喘三聯療法,由於 SITT 類別在美國 COPD 患者類別中的滲透率仍僅為 28%,因此還有成長空間。

  • Overall, General Medicines were down 2% for the quarter, due to negative RAR impact, slightly offset by Trelegy demand and continued post-pandemic recovery of the EU and international antibiotic market. Taking everything into account, we now anticipate low to mid-single-digit growth this year.

    總體而言,由於 RAR 的負面影響,普通藥品本季下降了 2%,但被 Trelegy 需求以及歐盟和國際抗生素市場在疫情後的持續復甦所略微抵消。考慮到所有因素,我們現在預計今年將出現低至中個位數的成長。

  • And with that, I'll now hand over to Deborah to cover HIV.

    就這樣,我現在將把愛滋病毒的報道交給黛博拉。

  • Deborah Jayne Waterhouse - CEO of ViiV Healthcare & President of Global Health

    Deborah Jayne Waterhouse - CEO of ViiV Healthcare & President of Global Health

  • Thank you, Luke. Our HIV business delivered sales of GBP 1.6 billion in the third quarter, growing 15%. This growth was primarily driven by patient demand, which contributed 10 percentage points of growth, with the majority of the remaining 5 points from tender phasing in our international business. Our continued strong performance during this quarter means we are now increasing our guidance for full year growth to around 10%. Our performance benefited from strong patient demand for our oral 2-drug regimen and long-acting injectable medicines, which are now 53% of our total portfolio value.

    謝謝你,盧克。我們的 HIV 業務第三季銷售額達 16 億英鎊,成長 15%。這一增長主要是由患者需求推動的,患者需求貢獻了 10 個百分點的增長,其餘 5 個百分點的大部分來自我們國際業務的招標階段。本季我們持續強勁的業績意味著我們現在將全年成長指引提高至 10% 左右。我們的表現得益於患者對我們的口服兩種藥物療法和長效注射藥物的強勁需求,這些藥物目前占我們投資組合總價值的 53%。

  • Dovato delivered GBP 477 million in the quarter. Market performance reflects HCP belief in Dovato, which has firmly consolidated its position as the leading oral 2-drug regimen.

    Dovato 本季交付了 4.77 億英鎊。市場表現反映了 HCP 對 Dovato 的信心,Dovato 牢固地鞏固了其作為領先的口服兩種藥物療法的地位。

  • I'd like to spend a few moments describing our expectations around dolutegravir loss of exclusivity. In Europe, the composition of matter patent expires in July 2029. In the U.S., dolutegravir is protected by a composition of matter patents until April 2028, which includes an additional 6 months of exclusivity, following the completion of our pediatric studies.

    我想花一些時間來描述我們對多替拉韋失去獨佔權的期望。在歐洲,物質組合物專利將於2029 年7 月到期。在美國,多替拉韋在2028 年4 月之前受到物質組合物專利的保護,其中包括在我們的兒科研究完成後額外6 個月的獨佔權。

  • Dovato and Juluca are also protected by formulation and other patents in the U.S., which have expiry dates after the composition of matter patent. Therefore, we anticipate a longer exclusivity period in the U.S. for Dovato until December 2029, and Juluca until July 2030.

    Dovato 和 Juluca 也受到美國配方和其他專利的保護,這些專利在物質專利組合物之後到期。因此,我們預計 Dovato 在美國的獨佔期將延長至 2029 年 12 月,Juluca 在美國的獨佔期將延長至 2030 年 7 月。

  • Turning to our long-acting injectable portfolio. Cabenuva sales for the quarter were GBP 182 million, reflecting strong patient demand with higher levels of market access and reimbursement across the U.S. and Europe. Cabenuva continues to be supported by strong label evolution and data, which underpins confidence. Patient awareness of Cabenuva is high at over 70%, and around 2/3 of switches are coming from competitor products.

    轉向我們的長效注射產品組合。 Cabenuva 本季銷售額為 1.82 億英鎊,反映患者需求強勁,美國和歐洲的市場准入和報銷水平更高。 Cabenuva 繼續得到強大的標籤演進和數據的支持,這增強了信心。 Cabenuva 的患者認知度高達 70% 以上,約 2/3 的開關來自競爭對手的產品。

  • Moving on to prevention. [Cabotegravir], the world's first long acting injectable for the prevention of HIV delivered GBP 37 million in the quarter, and we are pleased by the momentum across the U.S. This, alongside the desire by prescribers, payers and governments for a new solution to help in the HIV epidemic gives confidence that the PrEP appropriate market in the U.S. will continue to grow strongly. We were also pleased to receive European approval for Apretude in September.

    繼續預防。 [Cabotegravir] 是世界上第一個用於預防愛滋病毒的長效注射劑,本季銷售額為3700 萬英鎊,我們對美國各地的勢頭感到高興,同時處方者、付款人和政府都希望有新的解決方案來幫助HIV 疫情的爆發讓人們相信美國的 PrEP 市場將繼續強勁成長。我們也很高興在 9 月獲得歐洲對 Apretude 的批准。

  • We're also pleased by the progress of our pipeline, which is focused on innovative long-acting regimens. We have 3 clear target medicine profiles to provide the world's first, sub-administered, long-acting regimen for treatment, and to provide ultra-acting regimens for treatment and prevention.

    我們也對我們的產品線的進展感到高興,該產品線專注於創新的長效治療方案。我們有3個明確的標靶藥物概況,提供世界上第一個分給藥的長效治療方案,並提供超效治療和預防方案。

  • In our recently HIV Meet the Management event, we confirmed that we are currently on track to deliver on every 4-month injectable regimen. This would enable us to double the dose interval, enabling clinic visits to be halved to just 3 per year, meaningfully increasing the benefit of long-acting measure for patients and health care systems.

    在我們最近的 HIV Meet the Management 活動中,我們確認我們目前正在按計劃提供每 4 個月的注射方案。這將使我們能夠將劑量間隔加倍,使每年就診次數減少一半至僅 3 次,從而有意義地增加長效措施對患者和醫療保健系統的益處。

  • For 4-monthly dosing and prevention, we said we can expect approval in the 2026 time frame and for 4-monthly agreements in 2027. We also provided greater clarity on our road map to further extend the dosing interval of our long-acting regimens in treatment to prevention to enable every 6 months dosing towards the end of the decade.

    對於每4 個月的給藥和預防,我們表示預計將在2026 年的時間範圍內獲得批准,每4 個月的協議將在2027 年獲得批准。我們還提供了更清晰的路線圖,以進一步延長我們的長效治療方案的給藥間隔從治療到預防,到本世紀末每 6 個月給藥一次。

  • To conclude, we remain very confident in our ambition to achieve a 5-years sales CAGR to 2026 of 6% to 8% and to maintain our innovation leadership in HIV. This combined with the continued growth of the long-acting market, gives us the potential to significantly replace the revenue from the Dolutegravir loss of exclusivity.

    總而言之,我們仍然對實現 2026 年 5 年銷售複合年增長率 6% 至 8% 的目標充滿信心,並保持我們在 HIV 領域的創新領先地位。這與長效市場的持續成長相結合,使我們有可能大幅彌補多替拉韋獨佔權損失帶來的收入。

  • I will now hand over to Julie.

    現在我將把任務交給朱莉。

  • Julie Belita Brown - CFO & Executive Director

    Julie Belita Brown - CFO & Executive Director

  • Thank you, Deborah, and good afternoon, everyone. As you've heard from the team, we've made great progress on our road map since the second quarter results, and we're well positioning into the end of the year. We continue to be focused on execution, our pipeline, capital allocation and investor engagement. And as Tony mentioned, we've had several regulatory approvals, including Ojjaara and Jemperli during the third quarter. And following our HIV Meet the Management Event in September, we look forward to holding a similar event focused on respiratory on the 30 of November. Please now turn to Slide 22.

    謝謝黛博拉,大家下午好。正如您從團隊那裡聽到的那樣,自從第二季度業績發布以來,我們在路線圖上取得了巨大進展,並且我們已經做好了迎接年底的準備。我們持續關注執行、通路、資本配置和投資者參與。正如東尼所提到的,我們已經獲得了多項監管部門的批准,包括第三季的 Ojjaara 和 Jemperli。繼 9 月舉辦的 HIV 管理會議活動之後,我們期待在 11 月 30 日舉辦一場類似的以呼吸系統為主題的活動。現在請翻到投影片 22。

  • Turning to the quarter, as I will cover the financials references to growth are at constant exchange rates, and I'll focus my comments on adjusted results.

    談到本季度,我將介紹財務數據中成長的參考資料是按固定匯率計算的,我將重點放在評論調整後的結果。

  • So starting with the income statement. Sales increased 16%, excluding COVID solutions, were up 10% overall, reflecting continued strong execution with the extremely successful launch of Arexvy. Gross margin improved 80 basis points, excluding COVID, and 360 basis points CER, including the impact of lower sales of (inaudible). SG&A growth was 14%, excluding COVID. And as a reminder, in Q3 last year, we had foreign exchange gains on the [Wyeth] collaboration, which contributed 3 points of reported SG&A growth this quarter due to the credit last year. Adjusted operating profit grew 22%, excluding COVID solutions, and 15% overall. The margin increased to 34%, driven largely by cost of goods improvements and operating leverage.

    那麼就從損益表開始。銷售額成長了 16%(不包括新冠肺炎解決方案),整體銷售額成長了 10%,反映出 Arexvy 的推出極為成功,持續強勁的執行力。毛利率提高了 80 個基點(不包括新冠疫情),毛利率提高了 360 個基點(固定匯率),其中包括銷量下降的影響(聽不清楚)。 SG&A 成長率為 14%,不含新冠疫情。提醒一下,去年第三季度,我們與惠氏 (Wyeth) 合作獲得了外匯收益,由於去年的信貸,該季度為本季度報告的 SG&A 增長貢獻了 3 個百分點。調整後營業利潤成長 22%(不含新冠疫情解決方案),整體成長 15%。利潤率增至 34%,主要得益於商品成本改善和營運槓桿。

  • Turning to the reported results. Total operating profit increased 83% to GBP 1.9 billion, and this was driven by overall performance, as well as favorable CCL movements and fair value gains from our stake in Haleon.

    轉向報告的結果。總營業利潤成長 83%,達到 19 億英鎊,這是由整體業績、有利的 CCL 走勢以及我們所持 Haleon 股份的公允價值收益推動的。

  • The reconciliation of total to adjusted results is included in the appendix. On currency, there was an adverse 6-point impact on sales, and 9 points on adjusted operating profit primarily due to the strengthening of sterling against the U.S. dollar. Please now turn to Slide 23.

    總結果與調整結果的調節結果包含在附錄中。在貨幣方面,銷售額受到 6 個百分點的不利影響,調整後營業利潤受到 9 個百分點的不利影響,這主要是由於英鎊兌美元走強。現在請翻到投影片 23。

  • Moving to the adjusted operating margin dynamics in the quarter. The margin increased to 170 basis points to 35% at CER and improved 180 basis points, excluding COVID solutions. Overall, cost of goods have been favorable, primarily reflecting reduced sales of lower margins of Xevudy and an improvement in mix towards specialty and vaccines.

    轉向本季調整後的營業利潤率動態。以固定匯率計算,利潤率增加至 170 個基點至 35%,並提高了 180 個基點(不包括新冠肺炎解決方案)。總體而言,商品成本有利,主要反映了 Xevudy 利潤較低導致銷售額減少以及特種產品和疫苗組合的改善。

  • Regarding SG&A, we are in an investment cycle, supporting our priority products. Our spend is focused on maximizing the launch of Arexvy, building awareness of RSV and catalyzing the global market expansion opportunity for Shingrix. We now have approval in 39 countries for Shingrix, and 18 countries for Arexvy. Specialty Medicines is also a targeted investment area, with clear opportunities for the long-acting HIV franchise and the launch of Ojjaara in oncology.

    關於SG&A,我們正處於投資週期,並支持我們的優先產品。我們的支出重點是最大限度地推出 Arexvy、建立 RSV 意識並促進 Shingrix 的全球市場擴張機會。目前,Shingrix 已在 39 個國家獲得批准,Arexvy 已在 18 個國家獲得批准。特種藥物也是一個有針對性的投資領域,為長效愛滋病毒特許經營權和 Ojjaara 在腫瘤學領域的推出提供了明顯的機會。

  • We confirm our guidance for SG&A this year, with growth broadly in line with sales. It is important to say that following a period of investment, we now expect to move to a period of delivering returns on that investment and building on the great foundation of performance. In this new cycle, SG&A growth will step down and will be accretive to profits in 2024. Next slide, please.

    我們確認了今年的 SG&A 指導,成長與銷售額大致一致。重要的是,在經過一段時間的投資之後,我們現在預計將進入一個獲得投資回報並建立良好績效基礎的時期。在這個新周期中,SG&A 成長將放緩,並將在 2024 年增加利潤。請看下一張投影片。

  • Adjusted earnings per share grew 17% overall and benefited from lower net finance expense, following debt restructuring and a favorable tax rate, partly offset by higher range profits, leading to an increase in noncontrolling interests. Next slide, please.

    調整後每股收益整體成長 17%,受益於債務重組和優惠稅率後淨財務費用的下降,但部分被較高範圍的利潤所抵消,導致非控制權益增加。請下一張投影片。

  • Cash generated from operations was GBP 4.4 billion in the year-to-date and GBP 1.4 billion lower than the prior year. There are 2 major items to call out. Firstly, the receipt of the Gilead settlement last year of GBP 0.9 billion, and secondly, the increase in working capital influenced by stronger Arexvy sales in Q3, and lower Xevudy collections.

    年初至今,營運產生的現金為 44 億英鎊,比前一年減少 14 億英鎊。有 2 個主要項目需要指出。首先,去年吉利德收到了 9 億英鎊的和解金,其次,第三季 Arexvy 銷售走強和 Xevudy 收款減少影響了營運資金的增加。

  • The Arexvy sales will come through in the fourth quarter cash flow. Free cash flow more than doubled to GBP 1.7 billion in the third quarter, and brought the 9-month year-to-date to an inflow of GBP 1.3 billion. Cash expectations for the year have improved, but we still anticipate that 2023 cash generated from operations will be slightly lower than 2022 due to the one-off received from Gilead last year. We confirm our commitment of more than GBP 10 billion of cash generated from ops by 2026. Net debt stands at GBP 17.6 billion, with free cash inflow and proceeds from the Haleon stake, partly deployed through business development and the acquisition of BELLUS Healthcare.

    Arexvy 的銷售將在第四季度實現現金流。第三季自由現金流增加了一倍多,達到 17 億英鎊,今年迄今 9 個月的流入量達到 13 億英鎊。今年的現金預期有所改善,但由於去年從吉利德收到的一次性資金,我們仍然預計 2023 年營運產生的現金將略低於 2022 年。我們確認到 2026 年從營運中產生超過 100 億英鎊現金的承諾。淨債務為 176 億英鎊,自由現金流入和來自 Haleon 股份的收益,部分透過業務發展和收購 BELLUS Healthcare 進行部署。

  • Turning now to the guidance on Slide 26. Given our sustained strong performance across all segments of the business, we are upgrading our guidance at CER for the full year. And as a reminder, guidance excludes the impact of COVID-19. We now expect sales to increase 12% to 13%. We expect adjusted operating profit to increase between 13% and 15% and adjusted earnings per share to increase 17% to 20%.

    現在轉向幻燈片 26 上的指導。鑑於我們在所有業務領域持續強勁的業績,我們正在升級全年的 CER 指導。提醒一下,指南不包括 COVID-19 的影響。我們現在預計銷售額將成長 12% 至 13%。我們預計調整後營業利潤將成長 13% 至 15%,調整後每股盈餘將成長 17% 至 20%。

  • The strength of the Arexvy launch has been ahead of our initial expectations. That is the main source of the guidance upgrade. Q3 sales of Arexvy benefited from strong demand and initial channel inventory build, with TRx volumes representing around 1/3 of the volumes sold.

    Arexvy 的推出力道超出了我們最初的預期。這是指導升級的主要來源。 Arexvy 第三季的銷售受益於強勁的需求和初始通路庫存的建立,TRx 銷售量約佔銷售量的 1/3。

  • As Luke referenced, we are projecting our forecast for the season in line with the high dose flu analogs, and therefore, we expect full year sales of around GBP 0.9 million to GBP 1 million. There is, however, still much to learn, given the novel nature of this new vaccine, including annual vaccination patterns, duration of protection competitor dynamics and what expert recommendations might be. And we anticipate further insight following the end of the U.S. flu season, which will inform our outlook for 2024. We look forward to updating you further as part of our full year results. I remain confident in our longer-term revenue ambition for Arexvy.

    正如盧克所提到的,我們對本季的預測與高劑量流感類似物一致,因此,我們預計全年銷售額約為 90 萬英鎊至 100 萬英鎊。然而,鑑於這種新疫苗的新穎性,仍然有很多東西需要學習,包括年度疫苗接種模式、保護期限、競爭對手的動態以及專家的建議可能是什麼。我們預計在美國流感季節結束後會得到進一步的見解,這將為我們對 2024 年的展望提供資訊。作為我們全年業績的一部分,我們期待向您提供進一步的最新資訊。我對 Arexvy 的長期收入目標仍然充滿信心。

  • Turning to the dynamics within upgraded guidance. Within sales, we're increasing our expectations across all product groups. We now anticipate vaccine growth of around 20%. Specialty medicines to grow low double-digits, and within this, HIV to grow around 10%. And general medicines to grow low to mid-single digits.

    轉向升級指導中的動態。在銷售方面,我們正在提高對所有產品組的期望。我們現在預計疫苗成長率約為 20%。特種藥物將達到低兩位數成長,其中愛滋病毒將成長 10% 左右。一般藥品的成長幅度為低至中個位數。

  • Moving down the P&L to operating profit. We now expect royalties to be around GBP 900 million, with no change to our expectations for the other lines of the P&L. To EPS, we expect lower interest expense to between GBP 650 million and GBP 700 million. In terms of currency, FX exchange rates were to hold at the closing rates on the 30th of September for the rest of the year. The estimated adverse impact on sterling turnover growth for the full year would be minus 2%. And on adjusted operating profit growth, it would be minus 4%.

    將損益表下移至營業利潤。我們現在預計特許權使用費約為 9 億英鎊,我們對損益表其他項目的預期沒有變化。對於每股收益,我們預計利息支出將下降至 6.5 億英鎊至 7 億英鎊之間。貨幣方面,今年餘下時間外匯匯率將維持在 9 月 30 日收盤價。預計對全年英鎊營業額成長的不利影響將為-2%。調整後的營業利潤成長將為-4%。

  • Finally, we remind you of a few modeling assumptions in 2024, namely the impact of (inaudible), the loss of Gardasil royalties and the tax rate likely being a couple of percentage points higher due to OECD legislation. More details on these are included in our pre-quarterly (inaudible), and I look forward to guiding more fully at the end of the year.

    最後,我們提醒您 2024 年的一些建模假設,即(聽不清楚)的影響、Gardasil 特許權使用費的損失以及由於 OECD 立法而可能提高幾個百分點的稅率。有關這些的更多詳細資訊包含在我們的季前報告中(聽不清楚),我期待在年底提供更全面的指導。

  • And thank you. And with that, I will hand back to Emma.

    謝謝你。說到這裡,我將把事情交還給艾瑪。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Julie. Turning lastly to Slide 27.

    謝謝,朱莉。最後轉向投影片 27。

  • So in summary, we are seeing strong and sustained improvements in our performance. This quarter marks the seventh consecutive quarter of competitive sales and profit growth, which supports an upgrade to our guidance for the year.

    總而言之,我們看到我們的業績強勁且持續的改善。本季是連續第七個季度實現有競爭力的銷售和利潤成長,這支持我們上調今年的指導。

  • We also remain very focused on strengthening our pipeline and our longer-term outlook with progress in vaccines, development of our long-acting HIV portfolio and new prospects in respiratory, all pointing to new growth opportunities for GSK.

    我們也仍然非常注重加強我們的產品線和長期前景,包括疫苗方面的進展、長效愛滋病毒產品組合的開發以及呼吸系統領域的新前景,所有這些都為葛蘭素史克帶來了新的成長機會。

  • We have strong performance as we enter 2024, and we look forward to keeping you updated on our progress.

    進入 2024 年,我們表現強勁,我們期待向您通報我們的最新進展。

  • Thank you for listening. And let's now please -- we'll move to the Q&A.

    感謝您的聆聽。現在讓我們進入問答環節。

  • Nick Stone

    Nick Stone

  • (Operator Instructions) With that, I'd like to take our first question from Graham Parry.

    (操作員說明)接下來,我想回答 Graham Parry 提出的第一個問題。

  • Graham Glyn Charles Parry - MD and Head of Healthcare Equity Research

    Graham Glyn Charles Parry - MD and Head of Healthcare Equity Research

  • Great. So I'll start with Arexvy. So there's a question on the level of discounting in the initial launch. So 2/3 of your 709 million was inventory and you've administered some, I think, 1.4 million, 1.5 million doses. That means underlying sales were in the sort of 230 to 240 range, and that would imply net price, probably more than 30% below the list price.

    偉大的。所以我將從 Arexvy 開始。因此,在最初推出時的折扣水準存在一個問題。因此,您的 7.09 億劑中有 2/3 是庫存,我認為您已經注射了 140 萬、150 萬劑疫苗。這意味著基本銷量在 230 到 240 之間,這意味著淨價可能比標價低 30% 以上。

  • So can I just check that's the right sort of ballpark? And is that mostly wholesaler discounting or retail pharmacy discounting to drive the initial inventory build, and something which we might see sort of ameliorate a little bit over time? Or is that just kind of where the competitive nature of the market is at the moment?

    那麼我可以檢查一下這是否是正確的大致情況嗎?批發商折扣或零售藥局折扣是否主要是為了推動初始庫存建設,並且隨著時間的推移,我們可能會看到這種情況有所改善?或者這就是目前市場競爭的本質?

  • And then secondly, I know Julie touched on this, but dynamics into next year. Just be interested in sort of what you're internally planning at the moment for 2024. You obviously don't have the initial inventory build. But how much of that inventory do you think is just sort of seasonal inventory builds as a pace to initial inventory build? And of course, you don't have the return of the HPV vaccinated this year, just be interested in sort of what you're internally planning at the moment for 2024. You obviously don't have the initial inventory build. But how much of that inventory do you think is just sort of seasonal inventory builds as a pace to your initial inventory build? And of course, you don't have the return of the page, people vaccinated this year. So any thoughts you have so far on how far penetrated you are into the easy wins of the (inaudible), et cetera. and how much tough it might be to get return or to new people to get vaccinated next year?

    其次,我知道朱莉談到了這一點,但明年的動態。只需對您目前內部為 2024 年制定的計劃感興趣即可。您顯然沒有初始庫存構建。但您認為其中有多少庫存只是季節性庫存建設,作為初始庫存建設的步伐?當然,您今年不會收到 HPV 疫苗的回歸,只是對您目前內部為 2024 年制定的計劃感興趣。您顯然沒有初始庫存建設。但您認為其中有多少庫存只是季節性庫存建設,作為初始庫存建設的步伐?當然,你沒有返回頁面,人們今年接種了疫苗。因此,到目前為止,您對(聽不清楚)等輕鬆獲勝的了解程度有什麼想法。明年返回或讓新人接種疫苗可能有多困難?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Well, we'll come to Julie in a minute on guidance and thoughts around next year. Although, obviously, we will mainly be giving you thoughts around next year, when we come to February 2024.

    好吧,我們稍後會向朱莉介紹明年左右的指導和想法。不過,顯然,我們主要會在明年(即 2024 年 2 月)左右向您提供想法。

  • And I would just remind everybody that whilst we are absolutely delighted with the fast and competitive start here on RSV, it is just the start of the first season, we remain very ambitious for the 3 billion at least that we expect this asset to represent.

    我想提醒大家的是,雖然我們對RSV 的快速且有競爭力的開局感到非常高興,但這只是第一個賽季的開始,我們仍然對至少30 億美元抱有雄心壯志,我們預計該資產將代表至少30 億美元。

  • But let's go to Luke first. Noting Graham, you will fully understand, we're not going to be declaring all our commercial details on this call. But Luke, do you want to comment more broadly?

    但讓我們先來看盧克。注意到格雷厄姆,你就會完全理解,我們不會在這次電話會議上宣布我們所有的商業細節。但是盧克,你想發表更廣泛的評論嗎?

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes, Graham. I mean I think we've been quite disciplined, taking a longer term around pricing and contracting, and it's landed quite well. I won't give you any more color than that in terms of the percentages at this point because I'm sure our friends in New York probably got up a little bit early this morning.

    是的,格雷厄姆。我的意思是,我認為我們一直非常自律,在定價和合約方面採取了較長的期限,而且效果很好。此時此刻,我不會向您提供比百分比更多的信息,因為我確信我們在紐約的朋友今天早上可能起得有點早。

  • But what I would say is, to build on Emma's point, I think in the short term, things are uncertain. We're very happy with the launch. In the long term, we're very certain. I think so far, if we look at some of the metrics, which I can try and help you with, it's about 50% co-administration with flu. There's a very large overlap with that population. And interestingly, around 15% of people are getting 3 shots when they come into the pharmacy. 85% is that 65 to 84 age population. So again, very similar to high-dose flu.

    但我想說的是,根據艾瑪的觀點,我認為短期內事情是不確定的。我們對這次發布感到非常高興。從長遠來看,我們非常確定。我認為到目前為止,如果我們看一些我可以嘗試幫助您的指標,大約有 50% 的人與流感同時服用。與該人群有很大的重疊。有趣的是,大約 15% 的人進入藥局時會注射 3 針。 85%是65歲至84歲的人口。再次強調,這與高劑量流感非常相似。

  • And yes, I think for the rest of the year, in terms of demand, you're still seeing good market research in terms of ACPs recommending it. So it's about 64% based on our latest market research, which is encouraging. And of course, the CDC is advising doctors to keep going. So that's on the positive side of the ledger.

    是的,我認為在今年剩餘的時間裡,就需求而言,您仍然會看到 ACP 推薦它的良好市場研究。根據我們最新的市場研究,這一比例約為 64%,這是令人鼓舞的。當然,疾病預防控制中心建議醫生繼續治療。這是帳本的正面。

  • But the fact is this -- our working hypothesis is this is more of a flu-like trajectory. And as people stop coming into pharmacies and we see a reduction in staffing levels of pharmacy who actually delivered these vaccines, then we're going to see a drop-off in demand. And that's a hypothesis at this point.

    但事實是——我們的工作假設是這更像是一種類似流感的軌跡。隨著人們停止進入藥房,並且我們看到實際提供這些疫苗的藥房人員數量減少,那麼我們將看到需求下降。這是目前的一個假設。

  • We'll obviously have a lot more color in Q4 to give you an update. And then as Emma said, I think we're very, very confident in terms of the 3 billion number that we've outlined in the past.

    顯然,我們會在第四季度提供更多的顏色來為您提供更新。正如艾瑪所說,我認為我們對過去概述的 30 億數字非常非常有信心。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • And obviously, looking forward to rolling forward with that 50 to 59, data 2, which is another essentially meaningful cohort. Julie, anything else you want to add?

    顯然,我們期待將數據 2 從 50 推到 59,這是另一個本質上有意義的群體。朱莉,你還有什麼要補充的嗎?

  • Julie Belita Brown - CFO & Executive Director

    Julie Belita Brown - CFO & Executive Director

  • No, I think actually Luke covered it extremely well. I think we've obviously looked at the levels of stock in the channel. We've looked at the rate of immunizations. We've seen the correlation with flu, as Luke mentioned, very, very close, and that's really informed our guidance.

    不,我認為實際上盧克把它講得非常好。我認為我們顯然已經研究了渠道中的庫存水準。我們研究了免疫接種率。正如盧克所提到的,我們已經看到與流感的相關性非常非常接近,這確實為我們的指導提供了資訊。

  • And in terms of 2024, I mean, I think we're going to -- as we come through the U.S. flu season, we're going to have a much clearer view of 2024 when we give our full year results. So we'll definitely update you at that stage more fully.

    就 2024 年而言,我的意思是,當我們度過美國流感季節時,當我們公佈全年業績時,我們將對 2024 年有一個更清晰的看法。因此,我們一定會在那個階段向您提供更全面的更新。

  • Nick Stone

    Nick Stone

  • Okay. Next question is going to be from Kerry Holford at Berenberg.

    好的。下一個問題將由 Berenberg 的 Kerry Holford 提出。

  • Kerry Ann Holford - Analyst

    Kerry Ann Holford - Analyst

  • I have a couple of questions for Tony, please, within R&D.

    我有幾個關於研發部門的問題想問托尼。

  • So firstly, on the (inaudible). So now you've got the full reach of your Phase II data, and you have recently signed that deal with JNJ to look at sequential therapy. Do you still remain confident you can offer [HBV] patients a functional cure, at least a proportion of them? And what do you expect that JNJ, siRNA to add here? And do you stand by your more than GBP 2 billion sales target for that asset?

    首先,關於(聽不清楚)。現在您已經獲得了 II 期數據的全部內容,並且最近與 JNJ 簽署了研究序貫療法的協議。您仍然有信心為 [HBV] 患者(至少其中一部分)提供功能性治癒嗎?您希望 JNJ、siRNA 在這裡添加什麼?您是否堅持​​該資產超過 20 億英鎊的銷售目標?

  • And then secondly, a broader question on R&D budgets. So here, we've seen significant growth in your budget over the past 18 months or so. And based on the pipeline you have ahead of you, and you're broadly happy with the annual budget that you've effectively been given this year. And the run rate looks to be about GBP 5.5 billion, or should we expect that R&D budget to continue to grow in the sort of low double-digit range that we've seen year-to-date going forward?

    其次,關於研發預算的更廣泛的問題。因此,我們看到您的預算在過去 18 個月左右的時間內顯著增長。根據您面前的管道,您對今年有效分配的年度預算普遍感到滿意。運行率看起來約為 55 億英鎊,或者我們是否應該預期研發預算將繼續以我們今年迄今看到的低兩位數範圍增長?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Kerry, Let's get started with HBV. And then I'll comment on the pipeline, but perhaps Emma, you might want to make a comment on R&D budget.

    克里,讓我們開始了解B型肝炎病毒。然後我將對管道發表評論,但也許艾瑪,您可能想對研發預算發表評論。

  • So first of all, I'm really pleased with this deal, Kerry. Let me just remind you because I'm going to anchor it in what we are, what we know about bepi and becoming increasingly confident about that is in the context of monotherapy, on top of nucleoside treatment that we achieve a durable functional cure for a significant proportion of the HBV population, the chronic HBV patient population.

    首先,我對這筆交易非常滿意,克里。讓我提醒您,因為我將把它錨定在我們是什麼、我們對bepi 的了解上,並且越來越有信心在單一療法的背景下,在核苷治療的基礎上,我們實現了持久的功能性治癒B型肝炎族群中,慢性B型肝炎患者族群佔很大比例。

  • And that's for individuals to have a surface antigen count of less than 3,000. Just as a reminder, that's about 40% of the 300 million individuals who are living with chronic hepatits B.

    這適用於表面抗原計數低於 3,000 的個體。提醒一下,這約佔 3 億慢性B型肝炎患者的 40%。

  • To put it in a nutshell, what the new deal with the JNJ siRNA does, it takes the broader population down to that target population of about 3,000 and below. So you should expect, and we're excited about the prospects, therefore, of seeing both in increased coverage in an ITT population and also a deepening of the therapeutic effect. And this is important, if you look at the mechanism of action of the JNJ siRNA, it works in complementary fashion to bepi. So further lowering viral DNA and the consequences of that, as I mentioned in the presentation.

    簡而言之,JNJ siRNA 新協議的作用是將更廣泛的人群減少到約 3,000 人及以下的目標人群。因此,您應該期待看到 ITT 族群的覆蓋率增加以及治療效果的加深,我們對此前景感到興奮。這一點很重要,如果你觀察 JNJ siRNA 的作用機制,你會發現它與 bepi 以互補的方式發揮作用。正如我在演講中提到的,進一步降低病毒 DNA 及其後果。

  • The other more important thing is that we've built a complex PK/PD model around response, which this will add to -- and in addition, using AI/ML and some really deep phenotyping on nearly 500 patients, established an understanding of the immune status required at the beginning of treatment for response. We're going to continue to add to that because with the deal in question, we got a number of ongoing Phase II studies.

    另一件更重要的事情是,我們圍繞著反應建立了一個複雜的PK/PD 模型,這將增加這一模型——此外,使用AI/ML 和對近500 名患者進行的一些真正深入的表型分析,建立了對治療開始時所需的免疫狀態才能產生反應。我們將繼續補充這一點,因為對於有問題的交易,我們進行了許多正在進行的二期研究。

  • So I'm really very pleased about where we are with that particular deal. For me, it strengthens on my expectations in terms of our ability to deliver a functional cure for a broader population of patients living with this disease.

    因此,我對我們在該特定交易中的進展感到非常滿意。對我來說,它增強了我的期望,即我們有能力為更廣泛的患有這種疾病的患者提供功能性治癒。

  • Let me just start, in terms of the question about R&D budget and growth, perhaps I'd just say a few brief things about the portfolio and then hand over to Emma.

    首先,關於研發預算和成長的問題,也許我會簡單說一些關於投資組合的事情,然後交給艾瑪。

  • So again, I'm really very pleased with where we are in the portfolio. Emma mentioned the, the strength that we have in our growing vaccines portfolio, particularly next year as you'll see more data coming from our mRNA platform, from MAPS and we have a number of important studies like, for example, therapeutic Herpes Simplex vaccine readout on POC that will again continue to hopefully deepen the importance of our adjuvant technology that is underscoring, I think, it's a fantastic clinical performance we see for Shingrix and for Arexvy.

    再說一次,我對我們在投資組合中的位置非常滿意。艾瑪提到,我們在不斷增長的疫苗組合中擁有優勢,特別是明年,因為您將看到來自我們的mRNA 平台、MAPS 的更多數據,並且我們有許多重要的研究,例如治療性單純皰疹疫苗POC 上的讀數將再次有望繼續加深我們的輔助技術的重要性,我認為,我們看到 Shingrix 和 Arexvy 的臨床表現非常出色。

  • Luke and I will say more the management about the cornerstones of depemokimab, Nucala and camlipixant in our respiratory portfolio, of course, I've just mentioned bepi.

    Luke和我會更多地談論我們呼吸產品組合中depemokimab、Nucala和camlipixant基石的管理,當然,我剛剛提到了bepi。

  • And then moving just briefly into oncology, Jemperli, most recently through the OS data that I mentioned earlier, continues to show its credentials as a very highly effective PD-1 inhibitor.

    然後,Jemperli 短暫進入腫瘤學領域,最近透過我之前提到的 OS 數據,繼續顯示其作為非常高效的 PD-1 抑制劑的資格。

  • And with all of that in place, I think we're well set with regards to our future ambitions and the budget required for that ambition. I'm in good shape about it. Emma?

    有了所有這些,我認為我們對未來的目標和實現該目標所需的預算已經做好了準備。我對此狀態很好。艾瑪?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Tony. I mean I think the -- there are 2 important things to emphasize strongly here. First of all, we've been very clear in our capital allocation framework, the #1 priority for the company is to invest in the pipeline, organic and inorganically. And that is why over the last 5 years, you've seen a significant step up in our R&D spending.

    謝謝,托尼。我的意思是,我認為──這裡有兩件重要的事情需要強調。首先,我們在資本配置架構中非常明確,公司的第一要務是對管道進行有機和無機投資。這就是為什麼在過去 5 年裡,我們的研發支出顯著增加。

  • What matters is not how much you spend but that you spend it super smartly. And that is ever improving and that we're continuing to fuel competitive profitable growth for our shareholders. So first thing is it is a priority, but it's about how we spend it. And I think we are broadly to more industry normal levels in terms of spending, but very much focused on the returns of that.

    重要的不是你花了多少錢,而是你花得非常聰明。這種情況正在不斷改善,我們將繼續為股東推動有競爭力的利潤成長。因此,首先,這是一個優先事項,但關鍵在於我們如何使用它。我認為,就支出而言,我們總體上已達到行業正常水平,但非常關注其回報。

  • And the second thing is we are absolutely committed to profitable growth, and we're in that chapter now. We're now in, I think, 7 consecutive quarters of competitive growth. Glad to upgrade guidance for the year, very confident about our 26 outlooks and our double-digit profit CAGR.

    第二件事是我們絕對致力於獲利成長,而我們現在正處於這個階段。我認為,我們現在已經連續 7 個季度實現競爭性成長。很高興升級今年的指導,對我們的 26 個前景和兩位數的利潤複合年增長率非常有信心。

  • This year, we expect R&D spend to increase slightly below our turnover levels, and we're not going to set an explicit target around it, but you can be very confident that the outlooks we've previously laid out, we are completely committed to and delighted about our progress against.

    今年,我們預計研發支出的成長將略低於我們的營業額水平,我們不會圍繞它設定明確的目標,但您可以非常有信心,我們之前提出的前景,我們完全致力於並對我們取得的進展感到高興。

  • Next question, please.

    請下一個問題。

  • Nick Stone

    Nick Stone

  • Okay. Next question is from Simon Baker at Redburn.

    好的。下一個問題來自 Redburn 的 Simon Baker。

  • Simon P. Baker - Head of Pharmaceutical Research

    Simon P. Baker - Head of Pharmaceutical Research

  • Two, if I may, please, both on the pipeline. And apologies if I missed it. I did lose sound at 1 point.

    兩個,如果可以的話,都在籌備中。如果我錯過了,我深表歉意。我確實有 1 點失去聲音。

  • But it looks like depemokimab is running slightly ahead of our previous expectations. I'm just wondering if you could give us an update there on the shift in the switch to study timeline?

    但看起來 depemokimab 的運作情況略高於我們先前的預期。我只是想知道您能否向我們提供有關轉為學習時間表轉變的最新資訊?

  • And then secondly, on the Janssen ADC. I wonder if you could just elaborate a bit on what attracted you to that asset? Obviously, we've not seen much data. You will have seen more than us. And I was wondering if it was data driven or whether it was driven by the fact that the payload and the linker bar 1 or 2 carbons is identical to Dato-DXd and therefore, gives you a high level of confidence in the potential of that ADC?

    其次是 Janssen ADC。我想知道您是否可以詳細說明一下該資產吸引您的原因?顯然,我們還沒有看到太多數據。你會比我們看到更多。我想知道它是數據驅動的,還是由有效負載和連接條 1 或 2 個碳與 Dato-DXd 相同這一事實驅動的,因此,讓您對該 ADC 的潛力充滿信心?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Well, coming to Tony on both of those, but just to flag, please do join us on the 30th -- or at least Tony and Luke, I should say, on the 30th of November, when they will update you on some -- the very exciting scale assets we have in respiratory, obviously, our homeland and our heartland, including depi and camlipixant as well.

    好吧,就這兩個問題來找托尼,但只是為了提醒一下,請務必在30 日加入我們——或者至少是托尼和盧克,我應該說,在11 月30 日,屆時他們將向您通報一些最新情況——我們在呼吸系統領域擁有非常令人興奮的規模資產,顯然是我們的祖國和中心地帶,包括 depi 和 camlipixant。

  • But Tony, you might want to comment a bit more on the trials that are ongoing and then also on the ADC, which is obviously completely in line with our ONC strategy.

    但是托尼,您可能想對正在進行的試驗以及 ADC 發表更多評論,這顯然完全符合我們的 ONC 戰略。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Sure, Simon. Yes, I'm pleased with the progress we're making on SWIFT-1 and 2. As you spotted, we've seen a slight acceleration in that. That was associated actually with also an acceleration in the ANCHOR study for nasal polyps.

    當然,西蒙。是的,我對我們在 SWIFT-1 和 2 上的進展感到滿意。正如您所發現的,我們看到這方面的進展略有加快。這其實也與鼻息肉 ANCHOR 研究的加速有關。

  • What that means is that the safety database that we need to underpin the file is now complete. You should expect, though, that we'll stay on schedule with regards to the analysis and publication of the data, and I won't be doing that until we get the results for the second SWIFT analysis, which still places us in the first half of next year.

    這意味著我們支撐該文件所需的安全資料庫現已完成。不過,您應該預料到,我們將按計劃進行數據分析和發布,並且在我們獲得第二次 SWIFT 分析結果之前我不會這樣做,這仍然使我們處於第一次分析的位置明年一半。

  • As far as the ADC deal is concerned, Simon, so yes, as you quite right, you point out in terms of linker payload, there are similarities to date to Dato-DXd, and therefore, we derive confidence from the improved profile that you see for ADCs carrying that linker payload.

    就ADC 交易而言,Simon,是的,正如您所說,您指出在鏈接器有效負載方面,迄今為止與Dato-DXd 存在相似之處,因此,我們從改進的配置文件中獲得了信心,您認為請參閱攜帶該連結器有效負載的 ADC。

  • Two important things, though, to stress in the context of this deal. One, the antigen B7-H4 is selectively expressed on gynecological cancers. That's why we went after the mechanism in line with our strategy to focus on women's cancers and heme.

    不過,在這筆交易中需要強調兩件重要的事情。第一,抗原B7-H4在婦科癌症上選擇性表現。這就是為什麼我們追求符合我們關注女性癌症和血紅素策略的機制。

  • And lastly, in that area as well, there is ample evidence that the use of (inaudible) inhibitors as on standard of care for chemotherapy, that's related in part probably to the fact that you see a lot of DNA instability in those cancers. And as I'm sure you're aware, (inaudible) summarizes work on that mechanism.

    最後,在該領域,也有充足的證據表明使用(聽不清楚)抑制劑作為化療的護理標準,這可能部分與您在這些癌症中看到許多 DNA 不穩定這一事實有關。我相信您已經知道,(聽不清楚)總結了該機制的工作。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Next question, please.

    請下一個問題。

  • Nick Stone

    Nick Stone

  • So next question is going to be from Andrew Baum at Citi.

    下一個問題將由花旗銀行的安德魯·鮑姆提出。

  • Andrew, you're there?

    安德魯,你在嗎?

  • Andrew Simon Baum - Global Head of Healthcare Research and MD

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • Yes, I am sorry about that. Two questions, please. One for Luke, and the other one for Tony.

    是的,我對此感到抱歉。請教兩個問題。一份給盧克,另一份給東尼。

  • So for Luke, could you talk to the impact of the removal of the Medicaid cap, the MP cap on your Genmab business, particularly respiratory next year in terms of quantifying the impact on revenue and earnings?

    那麼對於盧克來說,您能否談談取消醫療補助上限、MP 上限對您的 Genmab 業務的影響,尤其是明年呼吸系統對收入和收益的量化影響?

  • And then for Tony or I guess, Kim, if she's on. There was recently reported the Athena cohort with cabotegravir rilpivirine, there was a number of cases of viral rebound resistance, particularly in patients with high BMI or weight gain. Should we expect any label change as a function of observations in that cohort? And it was a limited number, but still it was notable that remarked upon.

    然後是托尼,或者我猜是金,就像她在的話。最近有報導稱,使用卡博特韋利匹韋林的 Athena 隊列中,存在許多病毒反彈抵抗的病例,特別是在高 BMI 或體重增加的患者中。我們是否應該預期標籤會根據該隊列中的觀察結果而改變?雖然數量有限,但仍然值得注意。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • We'll come to Deborah, actually, on the HIV pipeline first. And then Luke, back to you on the onco.

    事實上,我們首先要談談黛博拉的愛滋病毒管道。然後盧克,回到你關於onco的話題。

  • Deborah Jayne Waterhouse - CEO of ViiV Healthcare & President of Global Health

    Deborah Jayne Waterhouse - CEO of ViiV Healthcare & President of Global Health

  • Andy. So the Athena is a cohort study, it was presented at AICS 8 to 10 days ago. Actually, the finding is exactly in line with our clinical studies. So as you know, there are kind of characterize things that give you a higher likelihood of failing with cabotegravir rilpivirin, weight is one, so high BMI is one. And then obviously, A6, A1, sort of subtypes.

    安迪. Athena 是一項隊列研究,它於 8 到 10 天前在 AICS 上發表。事實上,這項發現與我們的臨床研究完全一致。如您所知,有一些特徵因素會導致您使用卡博特韋利匹韋林失敗的可能性更高,體重是其中之一,因此高 BMI 是其中之一。顯然,還有 A6、A1 等亞型。

  • And then lastly, if you resistant to rilpivirine. So we clearly guide that those patients, if you have 2 of those risk factors, you're more likely to fail. We guide that. And that's exactly what we saw in the Athena study in terms of the characteristics of those that failed. And it was in proportion with what we saw in the clinical study, which is obviously less than 1%.

    最後,如果您對利匹韋林抗藥性。因此,我們明確指導那些患者,如果您有其中 2 個風險因素,那麼您更有可能失敗。我們對此進行指導。這正是我們在雅典娜研究中看到的那些失敗者的特徵。而且和我們在臨床研究中看到的比例是一致的,明顯低於1%。

  • So no surprises, whatsoever, exactly what you would expect. And it just makes it more important that we continue to communicate through our sort of multi-barrier analysis data for whom Cabenuva is right and who probably shouldn't be taking the medicine, but it's a tiny proportion of the overall patient base that will get benefit from this medicine and nothing new. Luke?

    所以,無論如何,這並不奇怪,正如你所期望的那樣。更重要的是,我們繼續透過多重屏障分析數據進行溝通,哪些人適合 Cabenuva,哪些人可能不應該服用該藥物,但這只佔整個患者群的一小部分。從這種藥物中受益並沒有什麼新意。盧克?

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Sure. I mean, as I said at Q2, the exposure is USD 700 million. But of course, we've had notice. So we've got authorized generics in place. We've done some withdrawals that we've announced. We've done WACC adjustment with (inaudible). The other products impacted, of course, the Advair and Flovent and (inaudible).

    當然。我的意思是,正如我在第二季度所說,風險敞口為 7 億美元。但當然,我們已經注意到了。所以我們已經獲得了授權的仿製藥。我們已經宣布了一些提款。我們已經進行了 WACC 調整(聽不清楚)。當然,其他產品也受到了影響,包括 Advair 和 Flovent 以及(聽不清楚)。

  • Look, I think the impact is going to be sizable. We started to reflect that in RA adjustments now. But we need to judge to see what level of returns ultimately come back. There's also some variables in terms of the percentage of switch to authorized generics. But we do have competitive generics, for example, with Flovent. So they may pick up more volume making it a bit hard to forecast.

    聽著,我認為影響將會很大。我們現在開始在 RA 調整中反映這一點。但我們需要判斷最終的回報水準。轉向授權仿製藥的百分比也存在一些變數。但我們確實有具有競爭力的仿製藥,例如 Flovent。因此,它們可能會增加更多的銷量,這使得預測有點困難。

  • So long story short, I mean, we've been prepared for this. We've been working on it for a couple of years. I think we're in the strongest position possible but there is going to be a material impact on that USD 700 million. And that's why it's reflected in the outlook for General Medicines next year.

    長話短說,我的意思是,我們已經為此做好了準備。我們已經為此努力了幾年。我認為我們處於最有利的位置,但這將對這 7 億美元產生重大影響。這就是為什麼它反映在明年普通藥品的前景中。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • I mean, that's the really important point is it's a '24 ahead, but it's all included in our medium-term guidance of being broadly flat in this business where we've obviously seen a nice uptick in performance, not least as (inaudible) continues to power forward and lead the way. So all factored in and planned for. Next question, please?

    我的意思是,真正重要的一點是,這是24 年前的事情,但這一切都包含在我們的中期指導中,即該業務基本上持平,我們顯然看到了業績的良好上升,尤其是(聽不清)繼續前進並引領潮流。所以所有的因素都考慮在內併計劃好了。請下一個問題?

  • Nick Stone

    Nick Stone

  • So next question is going to be from Richard Parkes at BNP Paribas.

    下一個問題將由法國巴黎銀行的理查德帕克斯提出。

  • Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team

    Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team

  • Yes. Just a couple of questions. Firstly, on Arexvy. Can you talk about the unmet need in terms of severe disease in the 50 to 60 year old patient population, just so that we can get a sense of -- and also, kind of what you would expect in terms of ACIP recommendation, so we can get a sense of how that label update might impact the opportunity going into next year?

    是的。只是幾個問題。首先,關於 Arexvy。您能談談 50 至 60 歲患者群體中嚴重疾病方面未得到滿足的需求嗎?這樣我們就可以了解一下——而且,這也是您對 ACIP 建議的期望,所以我們可以了解標籤更新可能如何影響明年的機會嗎?

  • And then second question is on Jemperli. Just wondered if you could talk about your confidence in expanding the approval into the MMR proficient population. Obviously, I think there's sort of 2 options there. One is the overall survival data from part 1 of the study. So maybe you could talk about consistency of that benefit across those subgroups.

    第二個問題是關於 Jemperli 的。只是想知道您是否可以談談您對將批准範圍擴大到 MMR 熟練人群的信心。顯然,我認為有兩種選擇。一是研究第一部分的總體存活數據。因此,也許您可以討論這些亞組之間的利益的一致性。

  • And then the PARP inhibitor arm of Part 2 of the trial, I notice you don't include Zejula when you talk about Part 2 as an opportunity. So I just wondered about your confidence in the PARP inhibitor maintenance on the that study as well.

    然後是試驗第 2 部分的 PARP 抑制劑部分,我注意到當您將第 2 部分視為一個機會時,您沒有包括 Zejula。所以我只是想知道您對該研究中 PARP 抑制劑維持的信心。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • We'll come to you any minute on oncology, but perhaps let you can talk about the 50 to 59 opportunity, which is another 40 million people, by the way, in the U.S.

    我們隨時會就腫瘤學問題與您聯繫,但也許可以讓您談談 50 到 59 個機會,順便說一下,美國還有 4000 萬人。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes. Yes. I mean I think there's 2 advantages. One is just the 40 -- access to the 40 million people. And again, that lines up nicely with the overall Shingrix cohort. So there's lots of synergies there we can achieve. And then there's the broader advantage when we're contracting in the retail and non-retail settings because we'll be the only one there.

    是的。是的。我的意思是我認為有兩個優點。其中之一就是 40 人——接觸到 4000 萬人。再說一遍,這與整個 Shingrix 群體非常吻合。因此,我們可以實現很多協同效應。當我們在零售和非零售環境中簽訂合約時,會有更廣泛的優勢,因為我們將是那裡唯一的一個。

  • Our expectation at this point is it's going to be shared clinical decision-making. But as we speculated before the launch, and I think so far that's holding up, that's not been a barrier during this initial base of adoption. If you look at that 50 to 60 plus population, there's a sizable proportion of them that also have one or more comorbidities.

    我們目前的期望是共享臨床決策。但正如我們在發布前推測的那樣,而且我認為到目前為止,這仍然有效,在最初的採用基礎上,這並不是一個障礙。如果你觀察這 50 到 60 多人,你會發現其中很大一部分人也患有一種或多種合併症。

  • So it's attractive. And certainly, it resonates well with primary care doctors in terms of their support of the brand, which is around 71% in terms of their preference overall for Arexvy.

    所以它很有吸引力。當然,初級保健醫生對該品牌的支持也引起了很好的共鳴,他們對 Arexvy 的整體偏好約為 71%。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • And in terms of RUBY, particularly RUBY Part 2, just -- and indeed the MMRP population from the results that we described earlier this week.

    就 RUBY 而言,特別是 RUBY 第 2 部分,以及我們本週早些時候描述的結果中的 MMRP 群體。

  • Important to recognize that the RUBY Part 1 study was not powered to look at OS in the MMRP population, but rather OS for the overall population.

    重要的是要認識到,RUBY 第 1 部分研究的目的並不是考察 MMRP 人群的 OS,而是考察整個人群的 OS。

  • The way to think about this in context of both Part 1 and Part 2 is definitely isolating out the MMRP population and asking under what circumstances are we likely to see the most meaningful therapeutic effect for those. There are, for example, genotype considerations associated with part response in the Part 2 population that are important.

    在第 1 部分和第 2 部分的背景下思考這個問題的方法肯定是隔離 MMRP 人群,並詢問在什麼情況下我們可能會看到對這些人群最有意義的治療效果。例如,與第 2 部分人群中的部分反應相關的基因型考慮因素很重要。

  • I don't want to get caught on the details of those at this point in time. We're still waiting for the readouts, but it's fair to say that the filing strategy that we'll put around Jemperli in first-line will take account of all of the factors that I've just described as well as the competitive position.

    我現在不想了解這些細節。我們仍在等待結果,但可以公平地說,我們將在一線圍繞 Jemperli 制定的備案策略將考慮我剛才描述的所有因素以及競爭地位。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes. And I think to build on that competitive position, I mean, I think we're optimistic in terms of how the NCCN may read that. Of course, as you know, [GY-18] is not designed around an overall survival signal.

    是的。我認為,為了鞏固這一競爭地位,我認為我們對 NCCN 的解讀持樂觀態度。當然,如您所知,[GY-18] 並不是圍繞著整體生存訊號而設計的。

  • And it's very interesting since that initial label, we've gone from 300 to 900 accounts now stocking Jemperli in the U.S., so that has a flow-on effect and sales are up 10x after SGO.

    非常有趣的是,自最初的標籤以來,我們在美國的 Jemperli 庫存已從 300 個帳戶增加到 900 個,因此產生了連鎖效應,SGO 後銷售額增長了 10 倍。

  • And it's intriguing just looking at the market shares. If you look at that first line setting when it was obviously non-promoted initially, I mean, Keytruda was picking up around 40% of that business. Chemo have dropped from 40% down to 27%. And we had around 13% of that market. So I think there's an opportunity now to start to make the case versus GY-18 , the elements of the design and the survival signal to try and expand the usage of Jemperli in that setting.

    光是看市場佔有率就很有趣。如果你看看第一行的設置,當它最初顯然沒有促銷時,我的意思是,Keytruda 佔據了該業務的 40% 左右。化療從 40% 下降到 27%。我們佔據了大約 13% 的市場份額。因此,我認為現在有機會開始與 GY-18、設計元素和生存訊號進行對比,以嘗試擴大 Jemperli 在該環境中的使用。

  • So that's something we're quite excited about. And then, of course, Jemperli helps inform the thinking around RUBY 2.

    所以這是我們非常興奮的事情。當然,Jemperli 也有助於傳達有關 RUBY 2 的思考。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Exactly, just a couple of things to underscore to Luke's point to remind you about [GY-18] different patient population. We had a larger degree of (inaudible) and also arcona patients, which are harder to treat. And importantly as well, the resist sampling frequency for our study was smaller, which obviously is going to pick up failures. -- more quickly than the GY-18 case dose. So important to bear those 2 things in line when you consider the comparison of the of the 2 studies.

    確切地說,盧克提醒您有關 [GY-18] 不同患者群體的觀點,需要強調幾件事。我們有更大程度的(聽不清楚)和阿科納患者,這些患者更難治療。同樣重要的是,我們研究的抗蝕劑取樣頻率較小,這顯然會導致失敗。 ——比 GY-18 盒劑量更快。當您考慮比較兩項研究時,將這兩件事保持一致非常重要。

  • And Luke, I think as guided you correctly in thinking about (inaudible) as being informative with regards to how we might interpret the Part 2.

    盧克,我認為它正確地引導您思考(聽不清楚),因為它為我們如何解釋第二部分提供了資訊。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Next?

    下一個?

  • Nick Stone

    Nick Stone

  • So next question is from James Gordon at JPMorgan.

    下一個問題來自摩根大通的詹姆斯戈登。

  • James Daniel Gordon - Senior Analyst

    James Daniel Gordon - Senior Analyst

  • James Gordon, JPMorgan. I'm going to stick to Arexvy for my 2. The first one was about Arexvy and stocking. So it looks like about GBP 460 million of Arexvy restocking this quarter. And the guide for this year implies about GBP 200 million to GBP 300 million of sales in Q4. But what does this assume in terms of stocking unwind in Q4? How much stock do you need to keep in the market to support the product as an ongoing run rate?

    詹姆斯‧戈登,摩根大通。我將在我的 2 中堅持使用 Arexvy。第一個是關於 Arexvy 和襪子的。因此,Arexvy 本季補貨金額約為 4.6 億英鎊。今年的指南暗示第四季度的銷售額約為 2 億至 3 億英鎊。但這對第四季庫存減少有何假設呢?您需要在市場上保留多少庫存才能支援產品的持續運行速度?

  • And also, what are you thinking about ex U.S. stocking in Q4? Could there be a U.S. site stock up that we saw in Q3 in Q4?

    另外,您對第四季的美國庫存有何看法?我們在第三季看到的美國網站庫存是否會出現在第四季?

  • And the second question is a lead into that, which is Arexvy and the ex U.S. launch. So ex U.S. sales, I think, were only 1 million this quarter, where the product was approved in the EU back in June. And my understanding is you're not capacity constrained. So could ex U.S. start to ramp in Q4 this year? And looking into next year, could we see a big launch for ex U.S. Arexvy, could that be a big growth driver for next year? Or is it going to take a bit longer in Europe to get this going? And what are the gating factors to get ex U.S. Arexvy ramping, like what we've seen this quarter in the U.S.?

    第二個問題是一個引子,即 Arexvy 和前美國的發布。因此,我認為本季美國以外的銷量僅為 100 萬輛,而該產品早在 6 月就在歐盟獲得了批准。我的理解是你的能力不受限制。那麼,美國以外的地區今年第四季會開始成長嗎?展望明年,我們是否會看到前美國 Arexvy 的大規模推出,這是否會成為明年的巨大成長動力?或者歐洲需要更長的時間才能實現這一目標?前美國 Arexvy 的成長有哪些限制因素,就像我們本季在美國看到的那樣?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Okay. Well, we'll go to Julie first, just to deconstruct the guidance for Q4. And then, Luke around the globalization.

    好的。好吧,我們先去找朱莉,解構第四季的指導。然後,盧克圍繞全球化。

  • But you're absolutely right. This is a global opportunity, and I'll even include in that, the recent commercial deals we've been doing in second biggest market in the world, there could be an option on that for the future.

    但你是絕對正確的。這是一個全球性的機會,我甚至會包括我們最近在世界第二大市場進行的商業交易,未來可能會有一個選擇。

  • And just to repeat, we're very ambitious for this being a multibillion asset as we've committed before.

    再說一遍,正如我們之前所承諾的那樣,我們非常雄心勃勃,希望將其打造為數十億美元的資產。

  • But in terms of the very short term in its first season, Julie, do you want to comment on the guidance?

    但就第一季的短期而言,朱莉,您想對指導意見發表評論嗎?

  • Julie Belita Brown - CFO & Executive Director

    Julie Belita Brown - CFO & Executive Director

  • Yes. So what we've definitely found so far is of the sales of 709, in terms of immunizations into people's arms, we've got around equivalent of about GBP 230 million to GBP 250 million.

    是的。到目前為止,我們確實發現 709 的銷售額,就人們手臂的免疫接種而言,大約相當於 2.3 億至 2.5 億英鎊。

  • We were expecting -- I mean, the launch has been massively successful. We were expecting a stocking at this point because it's very, very analogous to what's happening with flu.

    我們期待——我的意思是,這次發射取得了巨大成功。我們此時正期待著襪子,因為這與流感的情況非常非常相似。

  • So I think I'll hand over to Luke in terms of the amount of inventory we expect to carry. You figure for Q4, by the way, was absolutely spot on in terms of the level of sales we expect to see in the remainder 200 to 300, and it's all to do with the stocking. So over to Luke.

    所以我想我會把我們預計持有的庫存量交給盧克。順便說一句,就我們預計剩餘 200 到 300 輛的銷售水平而言,第四季度的銷量絕對是準確的,而這都與庫存有關。那就交給盧克吧。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes. I mean if you look at the total marketing, it's about 2.71. And we've got 1.7 billion of that in arm.

    是的。我的意思是,如果你看看總行銷,它大約是 2.71。我們的手臂裡有 17 億美元。

  • Yes, I won't give you much more color. I mean, as Julie said, it's 2/3 of sale so far. And we'll obviously try and burn through that towards the end of the year to position ourselves well.

    是的,我不會給你更多的色彩。我的意思是,正如朱莉所說,到目前為止,銷量已經達到 2/3。顯然,我們將在今年年底前努力克服這個問題,以便為自己做好定位。

  • What we don't want is empty shelves or any window that Pfizer can get in there. That's why I'm being a little bit cute with the numbers here because it's very dynamic at this point.

    我們不想要的是空的貨架或輝瑞可以進入的任何窗戶。這就是為什麼我對這裡的數字有點可愛,因為它在這一點上非常動態。

  • In terms of EU, look, it's very early days. It's private. We've kept the price in a very tight collar with the U.S., like we've done with Shingrix, and our expectation is that we need to now navigate access. We've got early wins in Canada. We've got some very encouraging signs coming in Europe and other markets. So we'll see the full effect of that in 2024.

    就歐盟而言,現在還處於早期階段。這是私人的。我們與美國的價格保持在非常嚴格的水平,就像我們對 Shingrix 所做的那樣,我們的期望是我們現在需要導航訪問。我們在加拿大取得了早期勝利。我們在歐洲和其他市場看到了一些非常令人鼓舞的跡象。因此,我們將在 2024 年看到其全部影響。

  • And of course, the advantage in the European markets like Japan and other international markets is once we get the NIP, then the level of resourcing we need to do to drive patients is significantly lower.

    當然,在日本等歐洲市場和其他國際市場的優勢是,一旦我們獲得 NIP,那麼我們驅動患者所需的資源水平就會顯著降低。

  • And so from a P&L point of view, it's also very attractive. So 2024 for rest of world for Arexvy and yes, good start in the U.S.

    因此從損益表的角度來看,它也非常有吸引力。 2024 年,對於 Arexvy 來說,對於世界其他地區來說,是的,在美國也是一個好的開始。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • And just to repeat, we are definitely seeing increased openness and recognition of the value literally financial value of investing in prevention. And so that is indefinitely in part where we're seeing this faster rate, even currently in the private market of approvals because it's just a lot cheaper and there isn't a health care system more budget that isn't burdened at the moment.

    再說一遍,我們確實看到了人們對預防投資的實際財務價值的開放性和認可度的提高。因此,這在一定程度上是我們看到這種更快的速度的原因,即使是在目前的私人審批市場上,因為它便宜得多,而且目前沒有一個醫療保健系統有更多的預算不承擔負擔。

  • And they have more infrastructure in place, not least through pharmacy channels for distribution in many countries.

    他們擁有更多的基礎設施,尤其是透過在許多國家進行分銷的藥房管道。

  • So all of this underpins this broader confidence, but we're phenomenally [tight], listening from Luke's team as he's alluded to around the shape of the financial contribution. Next question, please?

    因此,所有這些都支撐了這種更廣泛的信心,但我們非常[緊張],聆聽盧克團隊的聲音,因為他提到了財務捐贈的形式。請下一個問題?

  • Nick Stone

    Nick Stone

  • So I'm mindful we're just over the hour mark. We still got 6 individuals with hands raised.

    所以我注意到我們剛剛過了一個小時。我們還有 6 個人舉手。

  • So what I propose is that we try and work through as many of those as possible to a quarter past the hour, and then we'll close the call there.

    因此,我的建議是,我們嘗試在一刻鐘前完成盡可能多的問題,然後我們將在那裡結束通話。

  • So our next question comes from Mark Purcell at Morgan Stanley.

    我們的下一個問題來自摩根士丹利的馬克·珀塞爾。

  • Mark Douglas Purcell - Equity Analyst

    Mark Douglas Purcell - Equity Analyst

  • On Arexvy, a little bit more color. I just wondered if there's any early indications of out of seasonal demand for RSV vaccination.

    在 Arexvy 上,顏色多一點。我只是想知道是否有任何早期跡象表明 RSV 疫苗接種需求超出季節性。

  • (inaudible), there may be more of a sort of a Prevnar flu hybrid model. I know you'll know more by the end of the year, but any early indications there?

    (聽不清楚),可能有更多的 Prevnar 流感混合模型。我知道到今年年底你會知道更多,但有什麼早期跡象嗎?

  • And in pharmacies where Pfizer is fully stocked alongside you, given that they talk about how they're not fully launched yet, what is your market share in those pharmacies where both products are present?

    在輝瑞(Pfizer)與您一起備貨充足的藥局中,鑑於他們談論它們尚未完全推出,那麼您在同時銷售這兩種產品的藥店中的市場份額是多少?

  • And then a quick one for Tony. In terms of the inflation reduction and considerations on R&D, where you have assets just like your IL-18, where you could run parallel trials across a multiple number of indications. Do you see the sort of pressure to do that? And so like IL-5, could you do a BRIDGE study or would you have to do a separate study in COPD?

    然後托尼快速發言。在降低通貨膨脹和研發方面的考慮方面,您擁有像 IL-18 這樣的資產,您可以在多個適應症上進行平行試驗。你看到這樣做有多大的壓力嗎?與 IL-5 一樣,您可以進行 BRIDGE 研究還是必須針對 COPD 進行單獨的研究?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Okay. Luke and Tony?

    好的。盧克和東尼?

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Mark. We're beating them everywhere so far. The aim is to keep that happening. So yes, I mean, look, it's really -- it's interesting. I mean when you look at pharmacist prioritization, RSV is up there with flu (inaudible). You've seen COVID volumes drop off. And last week, we still get growing with Arexvy, which is encouraging. I was sort of wondering whether it would start to slow down.

    標記。到目前為止,我們在各方面都擊敗了他們。我們的目標是讓這種情況持續發生。所以是的,我的意思是,看,這真的很有趣。我的意思是,當您查看藥劑師的優先順序時,RSV 與流感處於同一位置(聽不清楚)。您已經看到新冠肺炎病例數量下降。上週,我們仍然與 Arexvy 一起成長,這是令人鼓舞的。我有點想知道它是否會開始放緩。

  • So this next couple of weeks, script data will really be interesting. It's more than 90% in the retail setting, and that's another critical component in your assumptions. And we don't actually expect that to materially change. We think vaccines, the maternal in OBGYN and PCP offices will occur, which will something will have to back out in future calculations.

    因此,接下來的幾週,腳本數據將會非常有趣。超過 90% 是在零售環境中,這是您假設中的另一個關鍵組成部分。我們實際上並不期望這種情況會發生實質改變。我們認為疫苗、婦產科和 PCP 辦公室的孕產婦將會出現,這將在未來的計算中不得不取消。

  • But we think the old adult market is going to be very much like flu, very much like Shingrix heading in the direction of retail.

    但我們認為老年人市場將非常像流感,非常像 Shingrix 朝著零售方向發展。

  • So we'll just see what people's enthusiasm is over the next couple of weeks. Clearly, awareness is very high. intention to recommend is very high. So again, I'm very happy to sort of back the truck up with everything that we know in Q4 and give you much more color around the market research that we will have at that point.

    因此,我們將在接下來的幾週內看看人們的熱情如何。可見,認知度非常高。推薦意向非常高。再說一次,我很高興用我們在第四季度所知道的一切來支援卡車,並為您提供有關我們屆時將進行的市場研究的更多資訊。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Thanks. And Tony, anything to add?

    偉大的。謝謝。東尼,還有什麼要補充的嗎?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. Just 2 very quick ones then in terms of the IL-18 question. Look, the key question we're asking with IL-18 at the moment is its efficacy relative to (inaudible) in atopic dermatitis, for the medium term as we build out our biomarker strategy, and look for markers of efficacy at Phase I. That's exactly the underpinnings that I would then want to have the confidence to go forward into multiple indications.

    是的。關於 IL-18 問題,只有 2 個非常快的問題。看,我們目前對 IL-18 提出的關鍵問題是,在我們制定生物標記策略並尋找 I 期療效標誌物的中期,IL-18 相對於異位性皮膚炎(聽不清楚)的療效。這正是我希望有信心進入多種適應症的基礎。

  • You probably have in mind that in case of IL-8 in the mandatory randomization also points to inflammatory bowel disease, obviously, a range of considerations there beyond just IRA in terms of whether not that's a path to go.

    您可能已經想到,強制隨機化中的 IL-8 也表明發炎性腸道疾病,顯然,除了 IRA 之外,還需要考慮一系列因素來確定這是否是一條可行的道路。

  • And then lastly, for MAT2A and the BRIDGE for depi, let's see where we go when we get the (inaudible) results. Obviously, we're focusing very much on the role of EOS in driving the morbidity and mortality associated with COPD. So will be part of our strategy, but I'm focused at the moment on making sure we get the results out to (inaudible) and to bring success. Emma, any color to that?

    最後,對於 MAT2A 和 depi 的 BRIDGE,讓我們看看當我們得到(聽不清楚)結果時我們會去哪裡。顯然,我們非常關注 EOS 在推動 COPD 相關發病率和死亡率方面的作用。這將是我們策略的一部分,但我目前的重點是確保我們取得成果(聽不清楚)並取得成功。艾瑪,有什麼顏色嗎?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Yes. And of course, any allocation of capital is a combination of forecast forecast now has to take into account the area under the curve, whether it be by format or anything else.

    是的。當然,任何資本分配都是預測的組合,預測現在必須考慮曲線下的面積,無論是按格式還是其他方式。

  • Nick Stone

    Nick Stone

  • Next question is from Steve Scala, TD Cowen.

    下一個問題來自 TD Cowen 的 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • I'm just curious of Arexvy shipments in October support your conservative guide for the full year. So were they essentially 0? I would note that in the first quarter of 2018, GSK called out stocking for Shingrix, and then went on to beat in 10 of the next 12 quarters in the U.S.

    我只是好奇 Arexvy 10 月份的發貨量是否支持您全年的保守指南。那麼它們本質上是0嗎?我要指出的是,在 2018 年第一季度,葛蘭素史克(GSK)為 Shingrix 進行了備貨,然後在接下來的 12 個季度中的 10 個季度中在美國取得了勝利。

  • Second, I know you're beating Pfizer in RSV everywhere. But to what should we attribute the success they have had? Previously, you've said that you have a better vaccine, you're stronger in the commercial setting, yet they put up a big number as well. So to what do we attribute that?

    其次,我知道你們在 RSV 方面到處都擊敗了輝瑞。但我們應該將他們所取得的成功歸因於什麼呢?之前,你說過你有更好的疫苗,你在商業環境中更強大,但他們也給了一個很大的數字。那我們將其歸因於什麼呢?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Well, I'll ask Luke to overlays, Stephen, but thanks for the questions.

    好吧,我會請盧克覆蓋,史蒂芬,但謝謝你的問題。

  • And this is the first season that we've been through. We've given our dive for the reasons that I won't repeat, since we're under some timing pressure, but we will know a lot more Q4. And obviously, we remain extremely ambitious for this and our competitive focus is make sure that not only the size of the market is big, which is why we welcome competition, but that we are able to effectively reach the patients that need us, which is this more vulnerable (inaudible) cohort. Luke, anything you want to add?

    這是我們經歷的第一個賽季。我們已經進行了潛水,原因我不會重複,因為我們面臨一些時間壓力,但我們會在第四季度了解更多。顯然,我們對此仍然雄心勃勃,我們的競爭重點是確保不僅市場規模很大(這就是我們歡迎競爭的原因),而且我們能夠有效地接觸到需要我們的患者,這就是這個更脆弱(聽不見清)的群體。路克,你還有什麼要補充的嗎?

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes. And look, I think Shingrix's a different case, right? I mean, I was in the middle of that, we canceled the global launch. We redirected all of the volumes to the U.S. And we also, in the middle of the later year, had some synergies in manufacturing, which were surprising upside in terms of loss and packaging. So that's why we're able to get that volume ahead for Shingrix.

    是的。看,我認為 Shingrix 是一個不同的例子,對嗎?我的意思是,我正處於其中,我們取消了全球發布。我們將所有的銷售量重新轉移到美國。在去年年中,我們在製造方面也產生了一些協同效應,這在損耗和包裝方面有著令人驚訝的優勢。這就是為什麼我們能夠提前為 Shingrix 提供這一銷量。

  • Look, I think in terms of us versus Pfizer, first it's growing, companies are out driving volume, because this is an awareness game. You know, no one had heard of RSV, if you're -- a person in a population before that.

    看,我認為就我們與輝瑞而言,首先它在成長,公司正在推動銷量,因為這是一場意識遊戲。你知道,沒有人聽過 RSV,如果你是在此之前的人群中的一個人的話。

  • So having 2 companies promote. It's good. We have enormous respect for Pfizer. We like competing with them. They are a strategic competitor for us, if you look across PCV, meningitis, RSV and potentially shingles at some point. So it's nice to have this strong start. And again, yes, we want to keep this going.

    所以有兩家公司進行推廣。很好。我們非常尊敬輝瑞。我們喜歡與他們競爭。如果你看看 PCV、腦膜炎、RSV 和潛在的帶狀皰疹,它們就是我們的策略競爭對手。所以很高興有這個強勁的開始。再說一遍,是的,我們希望繼續下去。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Next question?

    下一個問題?

  • Nick Stone

    Nick Stone

  • Yes. Next question is from Peter Welford at Jefferies.

    是的。下一個問題來自 Jefferies 的 Peter Welford。

  • Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst

    Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst

  • I'm afraid, I'm sticking with Arexvy. Could you just -- You mentioned that retail was over 90% of the volume so far. Curious, are you why you're so confident that, that mix will continue? I mean obviously, Shingrix, it's varied over time. But I think your competitor made some comments that they think potentially in the fourth quarter and the back half of the season, it's going to switch more towards the non-retail segment where they see perhaps a greater competitive advantage.

    恐怕我還是選擇 Arexvy。您剛才提到,到目前為止,零售量佔銷售量的 90% 以上。很好奇,你為什麼如此有信心這種混合會繼續下去?我的意思顯然是,Shingrix,它隨著時間的推移而變化。但我認為你的競爭對手發表了一些評論,他們認為可能在第四季度和賽季後半段,它將更多地轉向非零售領域,他們認為在那裡可能有更大的競爭優勢。

  • I wonder if you could comment, I guess, on both of those, both from a capacity advantage point of view, and also how potentially this could change, I guess, during the course of the season?

    我想你是否可以從運力優勢的角度對這兩個問題發表評論,以及我想在賽季過程中這種情況可能會發生怎樣的變化?

  • And then just secondly, I wanted to stick with vaccines. But wondering if Tony could possibly give us an update at all on how you're thinking about mRNA. I know, we come back to this almost every quarter. There obviously have been some competitive developments in there. So I wonder if you could just give us a quick update on how you're looking at your strategy and updates from new flow we could get for your mRNA portfolioin 2024?

    其次,我想堅持使用疫苗。但我想知道 Tony 能否向我們介紹一下您對 mRNA 的看法的最新情況。我知道,我們幾乎每個季度都會討論這個問題。顯然,那裡已經出現了一些競爭性的發展。所以我想知道您是否可以向我們快速介紹您如何看待您的策略以及我們可以在 2024 年為您的 mRNA 產品組合獲得的新流程的更新?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Yes, we're very excited about mRNA. I'm going to come to Tony first. And remember, the 90% is all the asset add up, but we'll come back on that to Luke in a minute. But Tony, mRNA?

    是的,我們對 mRNA 感到非常興奮。我要先去找東尼。請記住,90% 是所有資產的總和,但我們稍後會向 Luke 解釋這一點。但是托尼,mRNA?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • So just very quickly then, I'm very pleased about the platform and how it's moving forward. We're now moving into Phase II in both COVID and flu, and our Phase II program for flu includes a range of options and doses that we've deduced from our Phase I study, looking at up to 8 antigen components, which we feel is the path forward to, I presume, resolving the B strain coverage question that exists.

    所以很快我就對該平台及其進展感到非常滿意。我們現在正在進入新冠病毒和流感的第二階段,我們針對流感的第二階段計劃包括我們從第一階段研究中推斷出的一系列選項和劑量,觀察多達 8 種抗原成分,我們認為我認為,這是解決現有B 菌株覆蓋問題的前進道路。

  • Also worthwhile pointing out that, that's likely to become a slightly simplified proposition as the (inaudible) strain is probably going to be removed in '24. But more on this when I've got the readout from the Phase II data.

    另外值得指出的是,這可能會成為一個稍微簡化的提議,因為(聽不清楚)壓力可能會在 24 年被消除。但當我得到第二階段數據的讀數時,會對此進行更多討論。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Luke, anything to add on that?

    路克,還有什麼要補充的嗎?

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes, Peter, I mean, I just sort of look at it at a macro level. You've got 83 million who are over 60. You add the 50, 59, that's another 40. So that's a 120. We think 90% of those are going to still come through.

    是的,彼得,我的意思是,我只是從宏觀層面來看它。 60 歲以上的人口有 8,300 萬人。加上 50 歲、59 歲,又是 40 歲。所以這是 120 歲。我們認為其中 90% 的人仍會度過難關。

  • If you look at a typical birth cohort, it's 4 million a year. So if I look at between now and the end of the year, that's about 1 million pregnant women. And then it's unknown how many of those will get a vaccine. There's the influencing availability, the antibody as well.

    如果你看一下典型的出生隊列,你會發現每年有 400 萬。因此,從現在到今年年底,大約有 100 萬孕婦。目前還不清楚其中有多少人會接種疫苗。有影響的可用性,還有抗體。

  • I think the other thing to keep in mind, and we're seeing this with Shingrix is there are a lot of practices that are driving patients to pharmacy because they are -- they don't want to navigate the IRA dimensions and then have a separate track for the commercial patients. So they're actually sending patients through to the pharmacy rather than sort of persisting with that themselves. So that's a bit unknown. But definitely, those maternal vaccines will be given in OB/GYN offices. We don't have the label there. So we'll need to exclude that from our market share calculations going forward.

    我認為要記住的另一件事是,我們在 Shingrix 中看到這一點是,有很多做法促使患者去藥房,因為他們不想在 IRA 維度中導航,然後擁有一個為商業患者提供單獨的軌道。所以他們其實是把病人送到藥房,而不是自己堅持下去。所以有點未知。但毫無疑問,這些孕產婦疫苗將在婦產科辦公室接種。我們那裡沒有標籤。因此,我們需要將其從未來的市佔率計算中排除。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • I think we've got time for one more?

    我想我們還有時間再談一談嗎?

  • Nick Stone

    Nick Stone

  • We do have time for one more. So apologies to those of you that we won't get to, but our last question comes from Emily Field at Barclays.

    我們還有時間再來一場。很抱歉我們無法回答這些問題,但我們的最後一個問題來自巴克萊銀行的艾米麗·菲爾德。

  • Emily Field - Head of European Pharmaceuticals Equity Research

    Emily Field - Head of European Pharmaceuticals Equity Research

  • And maybe I'll just ask one last one about Ojjaara. I was wondering if you could provide some context about how you're thinking of speed of uptake of this launch, particularly now that you did get the line-agnostic legal and if you're expecting more sort of upfront usage versus second-line use, and any early indicators you could give us?

    也許我會問最後一個關於 Ojjaara 的問題。我想知道您是否可以提供一些背景信息,說明您如何看待此次發布的採用速度,特別是現在您確實獲得了與生產線無關的法律,以及您是否期望更多的前期使用而不是二線使用,您可以給我們任何早期指標嗎?

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • So first, we've got about 172 patients on so far. The bulk of those are sort of jack failures, highly anemic, so pretty severe cases. So that initial bolus, I think, will work through.

    首先,到目前為止我們已經接診了大約 172 名患者。其中大部分是千斤頂故障,高度貧血,所以情況相當嚴重。所以我認為最初的推注將會起作用。

  • Our working assumption is that between 40% and 50% of patients presenting are anemic at diagnosis. And as you know, we've got an outstanding recommendation there in terms of 2-A, and the most competitive profile in that subgroup.

    我們的工作假設是 40% 到 50% 的患者在診斷時患有貧血。如您所知,我們在 2-A 方面獲得了出色的推薦,並且在該小組中最具競爭力。

  • And we also know that around 46% of patients require a transfusion within 1 year of diagnosis. So that's our target. That's our target market.

    我們也知道,大約 46% 的患者在診斷後 1 年內需要輸血。這就是我們的目標。這就是我們的目標市場。

  • We think right now, yes, third line it's a couple of months, but we'll work our way up. second-line typical treatment length is 18 months, but we should be able to start to penetrate in 2024 that first line where typical treatments around 26 months of duration.

    我們現在認為,是的,第三線還需要幾個月的時間,但我們會努力向上。二線的典型治療長度為 18 個月,但我們應該能夠在 2024 年開始滲透到一線,典型的治療持續時間約為 26 個月。

  • And we got the NCCN data into them 2 hours was in an approval, and we were very happy with the recommendation.

    我們將 NCCN 數據放入其中 2 小時就獲得了批准,我們對這個建議非常滿意。

  • So, so far so good, a lot of academic interest, that's about 55% of the volume right now, 45% in the community. Of course, we expect that to change in time. But a lot of excitement, and this is clearly a visible problem for hematologists. And yes, they're very supportive of momelotinib. So, so far, so good.

    所以,到目前為止一切順利,學術興趣濃厚,目前約佔總量的 55%,社區中佔 45%。當然,我們希望這種情況能夠及時改變。但令人興奮的是,這對血液學家來說顯然是一個明顯的問題。是的,他們非常支持莫洛替尼。所以,到目前為止,一切都很好。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Wonderful. Thanks, Luke. Well, look, we'll look forward to coming back to more of your questions over the coming days and weeks. So I just want to leave you with the recap that we are delivering strong and sustained performance momentum with another quarter of double-digit sales and the earnings growth.

    精彩的。謝謝,盧克。好吧,我們期待在接下來的幾天和幾週內回覆您的更多問題。因此,我只想讓您回顧一下,我們正在提供強勁且持續的業績勢頭,又一個季度實現兩位數的銷售額和盈利增長。

  • This is broadly based performance, but of course, benefiting specifically from the very fast start of Arexvy, which we're looking forward to seeing its progress ahead.

    這是基於廣泛的性能,但當然,特別受益於 Arexvy 的快速啟動,我們期待看到它未來的進展。

  • Pleased to have an upgrade, but also really delighted with the momentum as we look ahead to delivering our '26 results and continuing to strengthen that longer-term outlook, as we keep aggressing the vaccines pipeline, longer acting HIV and exciting prospects in respiratory.

    很高興獲得升級,但也對我們期待交付 26 年結果並繼續加強長期前景的勢頭感到非常高興,因為我們不斷進軍疫苗管道、長效愛滋病毒和呼吸系統領域令人興奮的前景。

  • So thank you to everybody, and we look forward to catching up soon.

    謝謝大家,我們期待盡快趕上。