葛蘭素史克 (GSK) 2023 Q1 法說會逐字稿

(technical difficulty) was sent to our distribution list by e-mail, and you'll be also able to find it on gsk.com.

（技術難度）已通過電子郵件發送到我們的分發列表，您也可以在 gsk.com 上找到它。

Please turn to Slide 2. This is the usual safe harbor statement. We will comment on our performance using constant exchange rates, or CR unless stated otherwise. As a reminder, following the Consumer Healthcare demerger in 2022 to form Helion, we're presenting performance and growth of the continuing operations for GSK.

請轉到幻燈片 2。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 CR 來評論我們的表現。提醒一下，在 2022 年消費者保健分拆成立 Helion 之後，我們將展示 GSK 持續運營的業績和增長。

Please turn to Slide 3. Today's management presentation will last approximately 30 minutes with the remaining 30 minutes for your questions. (Operator Instructions) Our speakers are Emma Walmsley, Tony Wood, Luke Miels, Deborah Waterhouse and Iain Mackay with David Redfern joining the rest of the team for Q&A as we hit the end of the call. Julie Brown, who will officially start as CFO next week is also with us today on the call in listening capacity only as part of the CFO succession from [Nova]. Turning to Slide 4, I'll now hand the call over to Emma.

請轉到幻燈片 3。今天的管理演示將持續大約 30 分鐘，剩下的 30 分鐘用於您的提問。 （操作員說明）我們的發言人是 Emma Walmsley、Tony Wood、Luke Miels、Deborah Waterhouse 和 Iain Mackay，David Redfern 在電話結束時加入了團隊的其他成員進行問答。下週將正式開始擔任首席財務官的朱莉布朗今天也與我們一起參加電話會議，只是作為 [Nova] 首席財務官繼任的一部分。轉到幻燈片 4，我現在將電話轉給 Emma。

Thanks, Nick, and welcome to everybody. Please turn to the next slide. Our purpose is clear to get ahead of disease together by uniting science, technology and talent. We are preventing and treating disease at enormous scale and delivering a new chapter of growth. As a world leader in infectious diseases, we are also focused on building our business in HIV, immunology respiratory and oncology. And we're off to a strong start in 2023, showing our strategy continues to deliver for all stakeholders. Excluding Pandemic Solutions, we've delivered double-digit sales growth, including a fifth consecutive quarter of growth across the full portfolio with excellent commercial performances in Vaccines, Specialty and General Medicines. Our adjusted operating profit, excluding COVID-19 Solutions also grew by 5%, below the rate of sales growth this quarter due to some one-off factors as well as planned investment in new launches, and Iain will cover this in a moment. Our adjusted EPS grew by 14%, and we're firmly on track for our guidance this year. Our clear capital allocation priorities mean we continue to invest for growth and to deliver shareholder returns, and the Board approved a dividend of 14p for the quarter.

謝謝，尼克，歡迎大家。請翻到下一張幻燈片。我們的目的很明確，就是要聯合科學、技術和人才，共同戰勝疾病。我們正在大規模預防和治療疾病，開啟增長的新篇章。作為傳染病領域的世界領導者，我們還專注於在 HIV、免疫學、呼吸系統和腫瘤學領域開展業務。我們在 2023 年開局良好，表明我們的戰略繼續為所有利益相關者提供服務。不包括 Pandemic Solutions，我們實現了兩位數的銷售增長，包括整個產品組合連續第五個季度增長，在疫苗、專業和普通藥物方面具有出色的商業表現。我們調整後的營業利潤（不包括 COVID-19 解決方案）也增長了 5%，低於本季度的銷售增長率，這是由於一些一次性因素以及對新產品的計劃投資，伊恩稍後將介紹這一點。我們調整後的每股收益增長了 14%，我們堅定地走上了今年的指導方針。我們明確的資本分配優先事項意味著我們將繼續投資以實現增長並實現股東回報，董事會批准了本季度 14 便士的股息。

Please turn to Slide 6. Our continued commercial success comes with a focus on driving the performance of our key growth products, contributing a new record high 44% of our Q1 sales, adding GBP 500 million of additional revenue versus Q1 of last year. Notable contributions came from Shingrix and our HIV 2 drug regimens. Our growth drivers and new launches will support our growth over the decade and beyond. Our business mix continues to shift the Vaccines and Specialty Medicines, which are now delivering more than 60% of sales, and we're confident that this shift will progress to around 3/4 of our revenue by 2026. A large portion of the growth is due to our pipeline launches in recent years. New products launched since 2017 delivered GBP 2.2 billion during Q1 alone, underpinning our confidence in continuous future investment in pipeline development.

請轉到幻燈片 6。我們持續取得商業成功，同時專注於推動我們主要增長產品的性能，貢獻了我們第一季度銷售額的 44%，創歷史新高，與去年第一季度相比增加了 5 億英鎊的額外收入。 Shingrix 和我們的 HIV 2 藥物治療方案做出了顯著貢獻。我們的增長動力和新推出的產品將支持我們在未來十年及以後的增長。我們的業務組合繼續轉向疫苗和特殊藥物，它們現在佔銷售額的 60% 以上，我們有信心到 2026 年這種轉變將占我們收入的 3/4 左右。增長的很大一部分這是由於我們近年來推出的管道。自 2017 年以來推出的新產品僅在第一季度就實現了 22 億英鎊的收入，鞏固了我們對未來持續投資管道開發的信心。

Please turn to Slide 7. Our R&D progress is delivering on our priority to strengthen our long-term growth prospects. In infectious diseases, we're advancing our RSV older adult vaccine through the regulatory process and are on track to get the first U.S. FDA approval in May. And we also reported positive data last month on our pentavalent MenACWY vaccine for adolescents. We continue to invest in our priority vaccine platforms, including protein-based antigens, mRNA following some encouraging early data in flu this year and bacterial platforms like MAPS. In HIV, we presented positive data from long-acting Cabenuva compared to a daily oral medicine, and we continue to enhance our portfolio with business development. In March, we signed an exclusive license agreement with SCYNEXIS to access a first-in-class novel antifungal, adding to our growing anti-infectives portfolio. And we're also delighted to announce the proposed acquisition of BELLUS Health last week, further strengthening our specialty medicines and building on our respiratory expertise with a potential best-in-class treatment for refractory chronic cough. We expect to do more targeted business development in the year ahead. Tony and the team look forward to sharing updates on our continued pipeline development and progress throughout the year with a series of therapeutic area focused meeting the management events. I'll now hand it over to him for some more pipeline details.

請轉到幻燈片 7。我們的研發進展正在實現我們的首要任務，以加強我們的長期增長前景。在傳染病方面，我們正在通過監管程序推進我們的 RSV 老年人疫苗，並有望在 5 月獲得美國 FDA 的首次批准。上個月我們還報告了針對青少年的五價 MenACWY 疫苗的積極數據。我們繼續投資於我們的優先疫苗平台，包括基於蛋白質的抗原、繼今年一些令人鼓舞的流感早期數據之後的 mRNA 以及 MAPS 等細菌平台。在 HIV 方面，我們展示了長效 Cabenuva 與日常口服藥物相比的積極數據，並且我們繼續通過業務發展來增強我們的產品組合。 3 月，我們與 SCYNEXIS 簽署了獨家許可協議，以獲取一流的新型抗真菌藥物，從而增加我們不斷增長的抗感染藥物組合。我們也很高興上周宣布擬議收購 BELLUS Health，進一步加強我們的專業藥物，並在我們的呼吸專業知識的基礎上，為難治性慢性咳嗽提供潛在的一流治療方法。我們希望在未來一年進行更有針對性的業務發展。托尼和他的團隊期待通過一系列以治療領域為重點的會議管理活動，分享我們全年持續的管道開發和進展的最新情況。我現在將其移交給他以獲取更多管道詳細信息。

Thank you, Emma. Please turn to Slide 9. Our R&D strategy is focused across 4 therapeutic areas, shaped by our world-leading capabilities in infectious diseases, our understanding of the immune system and our technology capabilities. Our pipeline today comprises 68 assets in clinical development, around 2/3 of which target infectious disease and HIV. And we're making good progress in continuing to strengthen our growth prospects for 2026 and beyond. This quarter, we saw 2 U.S. FDA approvals, 2 advisory committees and several assets progress through the clinical development, including a Phase II start for our oligonucleotide NASH asset, GSK'990. We also started retreating into our Phase III program for bepirovirsen for the treatment of chronic hepatitis B. Our ambition for that is to improve functional cures for chronic hepatitis B patients and establishing a new standard of care. We look forward to presenting data from the Phase III B-Together trial in the second half of this year.

謝謝你，艾瑪。請轉到幻燈片 9。我們的研發戰略集中在 4 個治療領域，這些領域由我們在傳染病領域的世界領先能力、我們對免疫系統的理解和我們的技術能力共同塑造。我們今天的管道包括 68 項臨床開發資產，其中約 2/3 針對傳染病和 HIV。我們在繼續加強 2026 年及以後的增長前景方面取得了良好進展。本季度，我們看到 2 個美國 FDA 批准、2 個諮詢委員會和多項資產在臨床開發中取得進展，包括我們的寡核苷酸 NASH 資產 GSK'990 的 II 期啟動。我們還開始撤回用於治療慢性乙型肝炎的貝匹羅韋森 III 期項目。我們的目標是改善慢性乙型肝炎患者的功能性治愈並建立新的護理標準。我們期待在今年下半年公佈 III 期 B-Together 試驗的數據。

Next slide, please. Elsewhere in our infectious diseases portfolio, we reported 3 important developments in the quarter. Firstly, we received a positive recommendation from the FDA's Advisory Committee for our RSV vaccine Arexvy. We remain on track for an FDA decision anticipated by May 3. Our Phase III RSV study rerandomized subjects for a second season to receive either vaccine or placebo. These second season data will be important to better understand the duration of protection provided by Arexvy. Data collection is ongoing, and we expect a study report around midyear. Secondly, we announced positive data from our Men ABCWY Phase III trial, which demonstrated that our pentavalent vaccine has comparable protection to Bexsero and Menveo, was well tolerated with a safety profile consistent with Bexsero and Menveo. Invasive meningococcal disease is an uncommon but serious infection, which can cause life-threatening complications and death. 5 serogroups are responsible for the most meningococcal infections and there is currently no single approved vaccine which can protect against all 5 of these groups. Our pentavalent vaccine combines the antigenic components of Bexsero and Menveo. If approved, it could provide the broadest meningococcal serogroup coverage of the class and a simplified immunization schedule which we expect will lead to increased vaccine uptake. We will present preliminary data from this Phase III trial at ESCMID in May. We look forward to sharing these data with regulators to make this important vaccine innovation available as soon as possible.

請換下一張幻燈片。在我們的傳染病產品組合的其他方面，我們報告了本季度的 3 個重要發展。首先，我們收到了 FDA 諮詢委員會對我們的 RSV 疫苗 Arexvy 的積極推薦。我們仍有望在 5 月 3 日之前做出 FDA 的決定。我們的 III 期 RSV 研究將受試者重新隨機分配到第二季，以接受疫苗或安慰劑。這些第二季數據對於更好地了解 Arexvy 提供的保護期限非常重要。數據收集正在進行中，我們預計將在年中左右發布研究報告。其次，我們公佈了 Men ABCWY III 期試驗的陽性數據，表明我們的五價疫苗具有與 Bexsero 和 Menveo 相當的保護作用，且耐受性良好，安全性與 Bexsero 和 Menveo 一致。侵襲性腦膜炎球菌病是一種罕見但嚴重的感染，可導致危及生命的並發症和死亡。 5 种血清群是造成大多數腦膜炎球菌感染的原因，目前還沒有一種獲批的疫苗可以預防所有這 5 種群。我們的五價疫苗結合了 Bexsero 和 Menveo 的抗原成分。如果獲得批准，它可以提供最廣泛的腦膜炎球菌血清群覆蓋範圍和簡化的免疫計劃，我們預計這將導致疫苗接種率增加。我們將於 5 月在 ESCMID 上展示該 III 期試驗的初步數據。我們期待與監管機構共享這些數據，以盡快提供這一重要的疫苗創新。

Finally, at ECCMID, we presented positive Phase III data for gepotidacin in the treatment of uncomplicated urinary tract infections. In the U.S. alone, there are around 15 million UTI episodes each year, around 1/4 of which are resistant to existing treatments. Gepotidacin has the potential to become the first new class of antibiotics for uncomplicated urinary tract infection for over 20 years. To complement gepotidacin, we've also been active in business development. At the end of last year, we added tebipenem, a novel antibiotic in Phase III for complicated urinary tract infection to our infectious diseases portfolio. Also in March, we agreed to in-license Brexafemme, a novel oral glucan synthase inhibitor approved for treating vulvovaginal candidiasis. Together, these 3 novel agents will broaden our anti-infectious portfolio, an area of significant societal need.

最後，在 ECCMID 上，我們展示了 gepotidacin 在治療單純性尿路感染方面的陽性 III 期數據。僅在美國，每年就有大約 1500 萬例 UTI 發作，其中約 1/4 對現有治療具有耐藥性。 Gepotidacin 有潛力成為 20 多年來首個用於治療無並發症尿路感染的新型抗生素。為了補充 gepotidacin，我們還積極參與業務發展。去年年底，我們在傳染病產品組合中增加了替比培南，這是一種處於 III 期的新型抗生素，用於治療複雜的尿路感染。同樣在 3 月，我們同意獲得 Brexafemme 的許可，這是一種新型口服葡聚醣合酶抑製劑，已獲准用於治療外陰陰道念珠菌病。這 3 種新型藥物將共同擴大我們的抗感染產品組合，這是一個具有重大社會需求的領域。

Next slide, please. In HIV, we reported data from SOLAR, the first head-to-head study of our long-acting HIV treatment Cabenuva versus a daily oral therapy. SOLAR demonstrated non-inferior efficacy, a very low rate of neurologic failure and a strong patient preference for Cabenuva, with 90% of participants in the trial expressing a preference for the long-acting regimen. At CROI, we also present proof of concept data from N6LS, our broadly neutralizing HIV antibody. These data demonstrate high potency from a single antibody even at the lowest dose tested. On mutualizing antibodies just 1 asset currently in development is a potential combination partner for cabotegravir.

請換下一張幻燈片。在 HIV 方面，我們報告了來自 SOLAR 的數據，這是我們的長效 HIV 治療藥物 Cabenuva 與每日口服療法的首次頭對頭研究。 SOLAR 證明了非劣效性、極低的神經系統衰竭率和患者對 Cabenuva 的強烈偏好，90% 的試驗參與者表示偏好長效方案。在 CROI，我們還展示了來自 N6LS 的概念數據證明，N6LS 是我們廣泛中和的 HIV 抗體。這些數據表明，即使在最低測試劑量下，單一抗體也具有高效能。在互化抗體方面，目前正在開發的只有一項資產是 cabotegravir 的潛在組合夥伴。

Next slide, please. To augment our respiratory and specialty franchises, we're delighted with our recent agreement to acquire BELLUS Health, a late-stage biopharma company working to better the lives of patients suffering from refractory chronic cough or RCC. When completed, the acquisition will provide GSK access to Camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in Phase III development for the first-line treatment of adult patients with RCC. RCC effects around 28 million people globally and it is defined as a persistent cough lasting for more than 8 weeks that does not respond to treatment for an underlying condition. There are no approved medicines for RCC, which has a significant impact on quality of life with some patients experiencing over 900 coughs each day. Camlipixant has the highest P2X3 selectivity in the class. Phase II reported a very low incidents of Dysgeusia, a taste disturbance attributed to P2X3 selectivity that frequently leads to patients discontinuing treatment. Phase III trials are underway and are expected to read out by 2025. We're confident that the Phase III program will confirm the best-in-class profile and provide an excellent addition to our Specialty Medicines portfolio building upon our expertise in respiratory therapies.

請換下一張幻燈片。為了擴大我們的呼吸和專業特許經營權，我們很高興我們最近達成協議收購 BELLUS Health，這是一家後期生物製藥公司，致力於改善難治性慢性咳嗽或 RCC 患者的生活。收購完成後，葛蘭素史克將獲得 Camlipixant，Camlipixant 是一種潛在的同類最佳和高選擇性 P2X3 拮抗劑，目前正處於 III 期開發階段，用於成人 RCC 患者的一線治療。 RCC 影響全球約 2800 萬人，它被定義為持續超過 8 週且對潛在疾病的治療無反應的持續咳嗽。沒有批准用於 RCC 的藥物，這對生活質量有重大影響，一些患者每天咳嗽超過 900 次。 Camlipixant 在同類產品中具有最高的 P2X3 選擇性。 II 期報告了非常低的味覺障礙事件，這是一種由 P2X3 選擇性引起的味覺障礙，經常導致患者停止治療。 III 期試驗正在進行中，預計將於 2025 年宣讀。我們相信，III 期計劃將確認同類最佳的情況，並基於我們在呼吸治療方面的專業知識，為我們的專業藥物產品組合提供出色的補充。

Next slide, please. In oncology, we were pleased to report 2 significant developments adding to the evidence supporting to Sargon. The RUBY trial presented at SGO and ESMO meetings in March demonstrated a 72% reduction in the risk of disease progression or death in the dMMR population of patients with first-line advanced endometrial cancer. In the overall population, preliminary overall survival data showed a clinically meaningful trend and a 36% reduction in risk of death or progression in favor of the Sargon treatment. Endometrial cancer remains a significant unmet medical need. Over 400,000 new cases are reported annually with around 15% to 20% of patients presenting with advanced disease at the time of first diagnosis. We look forward to sharing these data with regulators as soon as possible. In February, a U.S. FDA advisory community voted to support our proposed trial design to evaluate Jemperli in treating locally advanced rectal cancer. The trial is now recruiting patients.

請換下一張幻燈片。在腫瘤學方面，我們很高興地報告了 2 項重大進展，增加了支持 Sargon 的證據。 3 月份在 SGO 和 ESMO 會議上提出的 RUBY 試驗表明，一線晚期子宮內膜癌患者的 dMMR 人群疾病進展或死亡風險降低了 72%。在總體人群中，初步總體生存數據顯示出具有臨床意義的趨勢，死亡或進展風險降低了 36%，這有利於 Sargon 治療。子宮內膜癌仍然是一個重大的未滿足的醫療需求。每年報告的新病例超過 400,000 例，其中約 15% 至 20% 的患者在首次診斷時已出現晚期疾病。我們期待盡快與監管機構共享這些數據。 2 月，美國 FDA 諮詢團體投票支持我們提議的試驗設計，以評估 Jemperli 治療局部晚期直腸癌的效果。該試驗目前正在招募患者。

Next slide, please. As pipeline momentum continues to build in vaccines, HIV and infectious diseases, this slide highlights important regulatory events and clinical data readouts anticipated in the next 12 months. A more comprehensive view of the portfolio is provided in the appendix. We anticipate an FDA decision for Arexvy, our RSV older adult vaccine in early May, with additional data to support the vaccine launch including those from a high-risk 50- to 59-year-old cohort additional sleep combinations and second season outcomes. In oncology, we anticipate an FDA decision for momelotinib in the treatment of myelofibrosis in June. We also anticipate presenting data from the B-Together Phase II trial which will provide evidence on the durability of response for hepatitis B patients receiving bepi and interferon. Part of our program to develop a functional peer for some of the 300 million people living with chronic hepatitis B infection today. The continuous progress we are making underpins my confidence that our pipeline will drive growth in the latter half of the decade. Recent data, pipeline progression and business development have further strengthened our R&D portfolio, and I look forward to sharing more data with you over the coming quarters and in the future meetings.

請換下一張幻燈片。隨著疫苗、艾滋病毒和傳染病的研發勢頭不斷增強，這張幻燈片重點介紹了未來 12 個月內預計的重要監管事件和臨床數據讀數。附錄中提供了更全面的投資組合視圖。我們預計 FDA 將在 5 月初對我們的 RSV 老年成人疫苗 Arexvy 做出決定，並提供更多數據來支持疫苗的推出，包括來自 50 至 59 歲高風險隊列的額外睡眠組合和第二季結果。在腫瘤學方面，我們預計 FDA 將在 6 月份對莫美洛替尼用於治療骨髓纖維化做出決定。我們還預計將公佈 B-Together II 期試驗的數據，該試驗將為接受 bepi 和乾擾素的乙型肝炎患者的反應持久性提供證據。我們計劃的一部分是為當今 3 億慢性乙型肝炎感染者中的一些人開發功能性同伴。我們正在取得的持續進步鞏固了我的信心，即我們的產品線將在本世紀後半葉推動增長。最近的數據、管道進展和業務發展進一步加強了我們的研發組合，我期待在未來幾個季度和未來的會議上與您分享更多數據。

I'll now hand over to Luke on Slide 15.

我現在將在幻燈片 15 上交給 Luke。

Thanks, Tony. Please turn to slide -- to the next slide. Strong commercial execution in the quarter continues to drive growth across our business. And as you can see on this slide, not only are product area is contributing to growth, but we've also increased sales in each region and provided a balanced strong portfolio with room to grow. Our improved commercial execution capabilities will play an essential role as we launch new products and value coming through the pipeline and via BD, including RSV vaccine for all the adults.

謝謝，托尼。請翻到下一張幻燈片。本季度強勁的商業執行力繼續推動我們業務的增長。正如您在這張幻燈片上看到的那樣，不僅產品領域對增長做出了貢獻，而且我們還增加了每個地區的銷售額，並提供了具有增長空間的平衡強大的產品組合。我們改進的商業執行能力將發揮重要作用，因為我們通過管道和 BD 推出新產品和價值，包括適用於所有成年人的 RSV 疫苗。

Please turn to Slide 17. This quarter, we delivered strong performance with sales up 10%, excluding Pandemic Solutions and in vaccine, strong growth of 9%, excluding COVID-19 solutions in the quarter were supported by Shingrix up 11% and meningitis up 25%. Shingrix delivered another record quarter of sales and a fifth consecutive quarter of growth, including increasing contributions across all geographies. Shingrix is now available in 31 countries with 39% of sales coming from outside the U.S. In specialty medicines, including HIV, which Deborah will speak about shortly, we increased sales by 13%, excluding Xevudy to GBP 2.2 billion. In immunology and respiratory, we continue to see growth from our market-leading medicines enlisted for SLE and lupus nephritis and Nucala for severe asthmas and other eos-driven diseases. Benlysta continues to be the leader across all major markets However, there's still plenty of growth with about 25% of bio penetration in the U.S. and even less in other key markets. Nucala remains the first and only biologic approved in 4 Eosinophilic diseases with new indications driving growth and differentiation. In China, the NRDL listing for EGPA has accelerated momentum, setting the foundation for our upcoming launch in severe asthma, and we look forward to our Phase III COP data in 2024. In oncology, sales grew 2% to GBP 136 million despite U.S. label changes for Blenrep Zejula and we remain focused on execution across the portfolio and look forward to the anticipated launch of momelotinib in myelofibrosis following the U.S. PDUFA date in June. Our General Medicines portfolio grew 9% to GBP 2.7 billion and the performance was predominantly reflecting the strong growth of Trelegy across all regions, which grew 28% this quarter.

請轉到幻燈片 17。本季度，我們表現強勁，銷售額增長 10%，不包括流行病解決方案和疫苗，強勁增長 9%，不包括本季度 COVID-19 解決方案，Shingrix 增長 11%，腦膜炎增長25%。 Shingrix 實現了另一個創紀錄的季度銷售額和連續第五個季度的增長，包括在所有地區的貢獻增加。 Shingrix 現在在 31 個國家有售，39% 的銷售額來自美國以外。在包括 HIV 在內的特殊藥物方面，Deborah 將很快談到，我們的銷售額增長了 13%，不包括 Xevudy 到 22 億英鎊。在免疫學和呼吸系統方面，我們繼續看到我們用於治療系統性紅斑狼瘡和狼瘡性腎炎的市場領先藥物以及用於治療嚴重哮喘和其他 EOS 驅動疾病的 Nucala 藥物的增長。 Benlysta 繼續成為所有主要市場的領導者然而，在美國的生物滲透率約為 25%，而在其他主要市場的滲透率則更低，因此仍有很大的增長空間。 Nucala 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，具有驅動生長和分化的新適應症。在中國，EGPA 的 NRDL 上市勢頭加快，為我們即將推出的嚴重哮喘奠定了基礎，我們期待 2024 年的 III 期 COP 數據。在腫瘤學方面，儘管有美國標籤，但銷售額增長了 2% 至 1.36 億英鎊Blenrep Zejula 的變化，我們仍然專注於整個產品組合的執行，並期待在 6 月美國 PDUFA 日期之後預期推出用於骨髓纖維化的 momelotinib。我們的通用藥品組合增長了 9%，達到 27 億英鎊，業績主要反映了 Trelegy 在所有地區的強勁增長，本季度增長了 28%。

We also saw a benefit from the strong allergy season in Japan and continued post pandemic recovery of our antibiotic Augmentin, which contributed GBP 177 million further emphasizing our expertise in this space as we move forward with novel antibiotics emerging from our pipeline and BD efforts. Considering this Q1 performance, we now expect General Medicine sales to be broadly flat to slightly down in the full year. We remain on track to deliver our existing 2023 sales outlook for vaccine and specialty medicines. And you can find these on Slide 35 of the presentation.

我們還從日本強烈的過敏季節中獲益，以及我們的抗生素奧格門汀在大流行後繼續恢復，這貢獻了 1.77 億英鎊，進一步強調了我們在這一領域的專業知識，因為我們正在推進從我們的管道和 BD 努力中出現的新型抗生素。考慮到第一季度的表現，我們現在預計全年全科藥品銷售額將基本持平或略有下降。我們仍有望實現現有的 2023 年疫苗和特種藥物銷售前景。您可以在演示文稿的幻燈片 35 上找到這些內容。

Please now move to Slide 18. As Tony mentioned, we expect an FDA decision for our candidate RSV vaccine very soon and RSV disease remains a significant unmet medical need, and our vaccine data showed exceptional overall efficacy, particularly in the most vulnerable populations. And we expect to be the first approved RSV vaccine in major markets, including the U.S., Europe and Japan. Our teams have begun disease awareness activities were needed, and our launch preparations are well underway. Overall, we have a competitive vaccine profile with compelling clinical evidence and multibillion Shingrix-like annual sales potential, and we look forward to keeping you updated as we launch this important vaccine.

現在請轉到幻燈片 18。正如 Tony 提到的，我們預計 FDA 很快就會對我們的候選 RSV 疫苗做出決定，RSV 疾病仍然是一個未滿足的重大醫療需求，我們的疫苗數據顯示出卓越的整體功效，尤其是在最脆弱的人群中。我們預計將成為主要市場（包括美國、歐洲和日本）首個獲得批准的 RSV 疫苗。我們的團隊已經開始開展疾病意識活動，我們的發布準備工作也在順利進行。總的來說，我們擁有具有競爭力的疫苗概況，具有令人信服的臨床證據和數十億的類似 Shingrix 的年銷售潛力，我們期待在我們推出這一重要疫苗時讓您了解最新情況。

With that, let me now hand over to Deborah on Slide 19.

有了這個，讓我現在將幻燈片 19 上的 Deborah 交給 Deborah。

Thanks, Luke. Our HIV business delivered sales of GBP 1.5 billion in the quarter in the first quarter of 2023, growing 15%. Our performance benefited from strong patient demand for our oral 2-drug regimens and long-acting injectable medicines, contributing around 10 percentage points of growth. U.S. pricing favorably contributed around 5 percentage points of growth. The inventory build we saw in the U.S. in Q4 of last year has been slower to burn than initially anticipated. We continue to believe this will burn through during the first half of the year. Dovato delivered GBP 396 million in the quarter. Market performance reflects HCP's belief in Dovato, which has become our #1 best-selling medicine in HIV. We were also pleased to receive EU approval of Triumeq PD in the quarter, the world's first single-tablet dispersible regimen for children with HIV.

謝謝，盧克。我們的 HIV 業務在 2023 年第一季度實現了 15 億英鎊的銷售額，增長了 15%。我們的業績得益於患者對我們的口服 2 種藥物療法和長效注射藥物的強勁需求，貢獻了約 10 個百分點的增長。美國定價有利地貢獻了約 5 個百分點的增長。我們在去年第四季度在美國看到的庫存增加比最初預期的要慢。我們仍然相信這將在今年上半年燃燒殆盡。 Dovato 在本季度交付了 3.96 億英鎊。市場表現反映了 HCP 對 Dovato 的信心，Dovato 已成為我們在 HIV 領域排名第一的最暢銷藥物。我們也很高興在本季度獲得歐盟對 Triumeq PD 的批准，這是世界上第一個針對 HIV 兒童的單片可分散方案。

Turning to Cabenuva. Sales for the quarter were GBP 127 million reflecting strong patient demand with high market access and reimbursement levels across the U.S. and Europe. Our sales and medical teams are reporting positive customer feedback after releasing the SOLAR data at CROI and our new direct-to-consumer advertising campaign is currently rolling out across the U.S. Moving on to prevention. Sales of Apretude, the world's first long-acting injectable for the prevention of HIV delivered GBP 24 million in the quarter, and we're pleased by the growing momentum across the U.S. We're encouraged 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 self-administered long-acting regimen for treatment and to provide ultra long-acting regimens for treatment and prevention with dosing intervals of 3 months or longer. We're excited about the potential of these medicine profiles and we'll be ready to regimen select in H1 2024.

轉向卡貝努瓦。本季度銷售額為 1.27 億英鎊，反映了美國和歐洲市場准入和報銷水平高的患者需求強勁。在 CROI 發布 SOLAR 數據後，我們的銷售和醫療團隊報告了積極的客戶反饋，我們新的直接面向消費者的廣告活動目前正在全美展開。轉向預防。 Apretude 是世界上第一個用於預防 HIV 的長效注射劑，該季度的銷售額為 2400 萬英鎊，我們對美國各地不斷增長的勢頭感到高興。我們對管道的進展感到鼓舞，重點是關於創新的長效療法。我們擁有3個明確的靶點藥物概況，提供全球首個自主給藥的長效治療方案，以及提供給藥間隔3個月或更長的超長效治療和預防方案。我們對這些藥物概況的潛力感到興奮，我們將準備在 2024 年上半年選擇方案。

In summary, our Q1 performance positions us well to deliver the mid-single-digit growth we expect this year, and we remain very confident in our ambition to achieve a 5-year mid-single-digit CAGR to 2026. The change in mix of our portfolio towards long-acting and the success of our pipeline offers the potential to significantly replace the revenue from the dolutegravir loss of exclusivity. And with that, I will hand it to Iain on Slide 20.

總而言之，我們第一季度的業績使我們能夠很好地實現我們今年預期的中等個位數增長，並且我們對到 2026 年實現 5 年中等個位數複合年增長率的雄心仍然充滿信心。組合的變化我們的產品組合向長效方向發展，我們管道的成功提供了顯著取代多替拉韋排他性損失帶來的收入的潛力。然後，我將在幻燈片 20 上將其交給 Iain。

Thanks, Deborah. As I cover the financials, references to growth are in constant exchange rates unless stated otherwise. As Luke and Deborah have covered the primary revenue drivers, I'll focus my comments on the income statement, including main cost drivers, margins, cash flow and guidance for 2023, including our latest phasing expectations.

謝謝，黛博拉。在我介紹財務數據時，除非另有說明，否則提及的增長均採用固定匯率。由於 Luke 和 Deborah 已經介紹了主要的收入驅動因素，我將把我的評論集中在損益表上，包括主要成本驅動因素、利潤率、現金流和 2023 年的指導，包括我們最新的分階段預期。

Turning to next slide. Before I go into the details of the quarter, I want to provide some context around the key factors influencing the performance of both total and adjusted results. As noted by the team, excluding COVID-19 solutions, we've shown strong operational delivery across the business, growing sales by 10% in the first quarter. Including Pandemic Solutions, sales were down 8%, mainly reflecting lower sales of Xevudy relative to Q1 of 2022. The 10% sales growth drove 5% adjusted operating profit growth, excluding COVID-19 solutions. This included a 4-point adverse impact from legal charges primarily related to the ZEJULA royalty dispute. Including the impact of COVID-19 solutions and those legal charges, adjusted operating profit was stable at GBP 2.1 billion. On a total basis, the lower sales, along with the Gilead settlement income of GBP 0.9 billion in the comparator resulted in operating profit being down 15%. On earnings per share, excluding COVID-19 Solutions, there was a 14% growth on an adjusted basis. The contribution from COVID Solutions reduced this growth rate by 7 percentage points with adjusted earnings per share up 7% at 37p. Total earnings per share were 36.8p down 8% on a continuing basis.

轉到下一張幻燈片。在我進入本季度的細節之前，我想提供一些關於影響總業績和調整後業績的關鍵因素的背景信息。正如團隊所指出的，不包括 COVID-19 解決方案，我們在整個業務中表現出了強勁的運營交付，第一季度銷售額增長了 10%。包括 Pandemic Solutions 在內，銷售額下降了 8%，主要反映了 Xevudy 的銷售額相對於 2022 年第一季度有所下降。10% 的銷售額增長推動了 5% 的調整後營業利潤增長，不包括 COVID-19解決方案。這包括主要與 ZEJULA 版稅糾紛相關的法律指控的 4 點不利影響。包括 COVID-19 解決方案的影響和那些法律費用，調整後的營業利潤穩定在 21 億英鎊。總的來說，較低的銷售額以及吉利德結算收入 9 億英鎊在比較中導致營業利潤下降 15%。每股收益（不包括 COVID-19 Solutions）在調整後增長了 14%。 COVID Solutions 的貢獻使這一增長率降低了 7 個百分點，調整後的每股收益增長 7% 至 37 便士。每股總收益為 36.8 便士，持續下降 8%。

Turning now to the main adjusting items of note between total and adjusted results for continuing operations in the quarter. These weren't transaction related with the net credit primarily reflecting these contingent consideration liability movements, the majority of which relates to foreign exchange. The currency impact was a favorable 5% of sales and 8% in adjusted earnings per share.

現在轉向本季度持續運營的總結果和調整結果之間的主要調整項目。這些與主要反映這些或有對價負債變動的淨信貸無關的交易，其中大部分與外匯有關。貨幣影響是銷售額的 5% 和調整後每股收益的 8%。

Turning to Slide 22. Adjusted operating margin was 30.1%. This was a 250 basis point improvement versus Q1 2022 at constant exchange rates. The improvement was primarily a function of the factors I've already described with lower sales of low-margin Xevudy benefiting cost of goods sold, partly offset by higher SG&A, which included the legal charges primarily related to the ZEJULA royalty dispute. In addition to these factors, there was continued commercial pipeline investment behind the key products. Turning to key cost line dynamics for the quarter. Within cost of goods sold, the 9.1 percentage point margin benefit was primarily from lower sales of low-margin Xevudy, but was partly offset by an unfavorable comparator to a onetime benefit from inventory adjustments in Q1 of last year as well as higher freight costs. SG&A growth was ahead of sales and had an adverse 4.9 percentage point margin impact. This primarily reflected launch investment, particularly focused on HIV and Shingrix to drive demand and support market expansion.

轉到幻燈片 22。調整後的營業利潤率為 30.1%。按固定匯率計算，與 2022 年第一季度相比提高了 250 個基點。改善主要是我已經描述的因素的函數，低利潤 Xevudy 的銷售額較低，受益於已售商品成本，部分被更高的 SG&A 所抵消，其中包括主要與 ZEJULA 特許權使用費糾紛相關的法律費用。除了這些因素之外，關鍵產品背後還有持續的商業管道投資。轉向本季度的關鍵成本線動態。在銷貨成本中，9.1 個百分點的利潤率收益主要來自低利潤率 Xevudy 的銷售額下降，但部分被不利比較器與去年第一季度庫存調整帶來的一次性收益以及更高的運費所抵消。 SG&A 增長快於銷售額，對利潤率產生了 4.9 個百分點的不利影響。這主要反映了啟動投資，特別是專注於 HIV 和 Shingrix 以推動需求和支持市場擴張。

There was also increased investments in preparation for the anticipated launches of our candidate RSV vaccine and momelotinib later in the year. The aforementioned increased legal charges added 4 percentage points to SG&A growth in the quarter. R&D spend grew 6% with continued investment across a combination of both early and later-stage programs, particularly in vaccines and specialty medicines. Within vaccines, this was driven by pneumococcal, mRNA and Phase II MMR programs. Within Specialty, the early-stage key assets included CCL17 for osteoarthritic pain and IL-18 for immune based diseases. In later clinical phases, there was a higher investment in Jemperli, momelotinib, depemokimab and bepirovirsen as those programs progressed. These dynamics were partially offset by decreases related to the completion of late-stage clinical development programs for otilimab, cell and gene therapy discontinuation and reduced R&D investment in Blenrep versus Q1 of 2022. Royalties benefited from Biktarvy's contribution, which includes an additional month in 2023 versus last year. And note that our GARDASIL royalty stream will cease at the end of this year.

我們還增加了投資，以準備在今年晚些時候推出我們的候選 RSV 疫苗和 momelotinib。上述增加的法律費用使本季度的 SG&A 增長增加了 4 個百分點。研發支出增長了 6%，持續投資於早期和後期項目，特別是在疫苗和特殊藥物方面。在疫苗中，這是由肺炎球菌、mRNA 和 II 期 MMR 計劃驅動的。在專業領域，早期的關鍵資產包括用於骨關節炎疼痛的 CCL17和用於免疫性疾病的 IL-18。在後期的臨床階段，隨著這些項目的進展，對 Jemperli、momelotinib、depemokimab 和 bepirovirsen 的投資增加了。與 2022 年第一季度相比，與 otilimab 的後期臨床開發計劃的完成、細胞和基因治療的停止以及 Blenrep 的研發投資減少相關的減少部分抵消了這些動態。特許權使用費受益於 Biktarvy 的貢獻，其中包括 2023 年的額外一個月與去年相比。請注意，我們的 GARDASIL 版稅流將在今年年底停止。

Next slide. Moving to the bottom half of the P&L, I'd highlight the net finance expense, mainly driven from the net savings from maturing bonds, including the sterling notes repurchased in the fourth quarter of last year and item plus income and cash. and that noncontrolling interests were lower due to Q1 2022 other noncontrolling interests not repeating. This was as expected.

下一張幻燈片。轉到損益表的下半部分，我要強調淨財務費用，主要來自到期債券的淨儲蓄，包括去年第四季度回購的英鎊票據以及項目加收入和現金。由於 2022 年第一季度其他非控股權益未重複，因此非控股權益較低。這符合預期。

On the next slide, I'll cover cash flow. In the first quarter, there was a free cash outflow of GBP 0.7 billion. Within free cash flow, cash generated from operations decreased to GBP 287 million, down 88%. This primarily reflected an unfavorable comparison due to upfront income from the settlement affiliate received in the first quarter of 2022 and the unfavorable timing of profit share payments to Vir Biotechnology related to sales of Xevudy. There was also an increase in seasonal inventory and lower payable balances reflecting increased investments in 2022. The low cash generated from operations, there were higher tax payments. Q1 performance and cash generation was in line with expectations and are on track to deliver outlooks this year.

在下一張幻燈片中，我將介紹現金流。第一季度，自由現金流出 7 億英鎊。在自由現金流中，運營產生的現金減少至 2.87 億英鎊，下降 88%。這主要反映了由於 2022 年第一季度從結算附屬公司收到的預付款收入以及向 Vir Biotechnology 支付與 Xevudy 銷售相關的利潤分成的不利時間而導致的不利比較。季節性庫存增加，應付餘額減少，反映出 2022 年投資增加。運營產生的現金較少，納稅額較高。第一季度的業績和現金產生符合預期，並有望在今年實現展望。

Turning to Slide 25 and considerations for our guidance for 2023. We delivered a good start to the year and are very much on track to deliver full year guidance. Given Q1 performance, we now expect full year phasing to be slightly different to that shared in February. Our Q1 performance benefited from slower-than-expected HIV inventory burn and particularly strong general medicines delivery due to anti-infectant market recovery and Japan allergy season dynamics, which we don't expect to persist through the year. For the second quarter, we expect to see destocking in HIV and for general medicines growth to moderate due to the seasonal effects. We, therefore, expect sales growth in Q2 to be lower than Q1. With these considerations in mind, we now expect first and second half sales growth to be broadly [simpler]. And within this, we now expect general medicines to be broadly flat to slightly down for the year. In the second half, we continue to expect the sales growth to be influenced by the comparator periods.

轉向幻燈片 25 和我們對 2023 年指導的考慮。我們今年開局良好，並且非常有望提供全年指導。鑑於第一季度的表現，我們現在預計全年階段將與 2 月份的情況略有不同。我們第一季度的業績得益於 HIV 庫存消耗速度慢於預期，以及由於抗感染藥市場復甦和日本過敏季節動態而導致的一般藥物交付特別強勁，我們預計這種情況不會持續到今年。對於第二季度，由於季節性影響，我們預計 HIV 和普通藥物的去庫存化將放緩。因此，我們預計第二季度的銷售增長將低於第一季度。考慮到這些因素，我們現在預計上半年和下半年的銷售增長將普遍 [更簡單]。在此範圍內，我們現在預計今年的普通藥物將大致持平或略有下降。下半年，我們繼續預計銷售增長將受到比較期的影響。

In HIV, these included U.S. channel inventory build and favorable U.S. pricing, particularly in Q4 of last year. In Gen Meds there was a post-pandemic recovery in the antibiotic market and the launch of Flovent anti generic in the U.S. in the second quarter of last year. For this year, we would also expect ongoing pricing pressure in Gen Meds, especially in the U.S. and European pricing [prefer] in the HIV market. With respect to operating profit growth, we still expect this to be lower than the first half of the year compared to the second half relative to full year expectations. This is informed by continued investment behind ongoing and anticipated launches, including our RSV vaccine and momelotinib. As such, we expect SG&A to grow ahead of sales in Q2, and we still expect SG&A to increase the rate broadly aligned turnover for the full year. On COVID-19 Solutions, we still do not anticipate significant future sales. However, based on Q1, we are revising the estimate for full year adverse adjusted operating profit impact to be 5 to 6 percentage points. We're off to a good start in 2023 with good momentum.

在 HIV 方面，這些包括美國渠道庫存建設和有利的美國定價，特別是在去年第四季度。在 Gen Meds 中，抗生素市場在大流行後復蘇，去年第二季度在美國推出了 Flovent 抗仿製藥。今年，我們還預計 Gen Meds 將面臨持續的定價壓力，尤其是在美國和歐洲 HIV 市場的定價[偏好]。關於營業利潤增長，我們仍然預計這將低於上半年和下半年相對於全年的預期。這是通過持續投資支持正在進行的和預期的發布，包括我們的 RSV 疫苗和 momelotinib。因此，我們預計 SG&A 的增長將超過第二季度的銷售額，我們仍然預計 SG&A 將提高全年營業額的增長率。在 COVID-19 Solutions 上，我們仍然預計未來不會有重大銷售。然而，基於第一季度，我們將全年不利調整後營業利潤影響的估計修正為 5 至 6 個百分點。我們以良好的勢頭在 2023 年有了一個良好的開端。

And with that, I'll hand it back to Emma.

有了這個，我會把它還給艾瑪。

Thank you, Iain. Turning to Slide 27. We have made building trust by operating responsibly, an integral part of our strategy and our culture. Ultimately, we are focused on delivering sustainable growth with returns to shareholders, reducing risk, helping our people to thrive and delivering health impact at scale. Our responsible business framework prioritizes 6 material areas. And last month, we published our ESG performance report on our progress in each including a new overall ESG rating that show we're on track based on 83% of all performance metrics being met or exceeded.

謝謝你，伊恩。轉到幻燈片 27。我們通過負責任的運營建立信任，這是我們戰略和文化的一個組成部分。最終，我們專注於實現可持續增長，為股東帶來回報，降低風險，幫助我們的員工茁壯成長，並大規模地產生健康影響。我們負責任的業務框架優先考慮 6 個重要領域。上個月，我們發布了我們的 ESG 績效報告，介紹了我們在每個方面的進展，包括一個新的整體 ESG 評級，該評級表明我們在所有績效指標中達到或超過了 83%。

On access, one of the most material areas of social responsibility in our sector and one where we are committed to lead, we made further progress, again, by expanding availability of our HIV prevention medicine, cabotegravir to 90 countries by signing an agreement with generic manufacturers by the Medicines Patent Pool. And we've also enhanced recruitment of diverse patient populations with 100% of our Phase III clinical trials now including a demographic plan as well as also making great progress in creating a diverse, equitable and inclusive workplace.

在獲取方面，我們部門社會責任最重要的領域之一，也是我們致力於領導的領域，我們再次取得了進一步的進展，通過與仿製藥公司簽署協議，將我們的 HIV 預防藥物 Cabotegravir 的可用性擴大到 90 個國家藥品專利池的製造商。我們還加強了對不同患者群體的招募，100% 的 III 期臨床試驗現在包括人口統計計劃，並且在創建多元化、公平和包容的工作場所方面也取得了巨大進展。

Turning to the final slide, 28. So we are off to a strong start in 2023 with all our growth drivers performing. We're very focused on our upcoming launches, including our potential RSV older adult vaccine and on continuing to strengthen our pipeline organically and through targeted business development in vaccines and specialty medicines. Our continued momentum commercially and in the pipeline supports our confidence in delivering on our outlook and ambitions to sustain our growth through this decade and beyond, and we look forward to sharing more details at upcoming events.

轉到最後一張幻燈片，28。所以我們在 2023 年有了一個良好的開端，我們所有的增長動力都表現出色。我們非常專注於我們即將推出的產品，包括我們潛在的 RSV 老年成人疫苗，並繼續有機地加強我們的管道，並通過疫苗和專業藥物的有針對性的業務發展。我們在商業和籌備中的持續發展勢頭支持我們實現我們的前景和雄心以維持我們在這十年及以後的增長的信心，我們期待在即將舉行的活動中分享更多細節。

Before closing, of course, I would like to recognize the outstanding contributions made by Iain Mackay as our CFO. This will be his last quarter, indeed, it's his last week before retiring from GSK. Iain has been a fantastic leader, great colleague and has made an enormous impact in his time here. And I really want to sincerely and personally thank him. Julie has been transitioning into the role with Iain and is officially starting in just a few days. And I know she is very much looking forward to spending time with you all as we continue to deliver progress together.

當然，在結束之前，我要感謝 Iain Mackay 作為我們的首席財務官所做的傑出貢獻。這將是他的最後一個季度，事實上，這是他從 GSK 退休前的最後一周。伊恩 (Iain) 是一位出色的領導者和出色的同事，在他任職期間產生了巨大的影響。我真的想真誠地親自感謝他。朱莉一直在與伊恩一起過渡到這個角色，並在短短幾天內正式上任。我知道她非常期待與大家共度時光，因為我們將繼續共同取得進步。

With that, ick, now I think you have (inaudible) coming into the Q&A.

說到這裡，我覺得你（聽不清）進入了問答環節。

Absolutely. Thanks, Emma. (Operator Instructions) And with that, our first question is coming from James Gordon. Please go ahead, James. (Operator Instructions) Okay. What we'll do is we'll move to Kerry Holford.

絕對地。謝謝，艾瑪。 （操作員說明）因此，我們的第一個問題來自詹姆斯戈登。請繼續，詹姆斯。 （操作員說明）好的。我們要做的是搬到克里霍爾福德。

Hi. Can you hear me, Nick.

你好。你能聽到我說話嗎，尼克。

Yes, we can.

我們可以。

We can.

我們可以。

Excellent. Lovely. A couple of questions, please on Camlipixant. Tony, you highlighted that around -- I think you said 28 million people suffer from RCC globally. But I'm wondering, are there specific patient subgroups and on markets that might be most amenable to drug therapy in this disease, perhaps more severe patients. And then I'm wondering whether you're willing to discuss potential peak sales that you might target for this asset? And I might just [chart] the last one. [Competition] in Merck has clearly faced issues with advocacy measurements in this space. How confident are you that your asset here won't see the same fate?

出色的。迷人的。關於 Camlipixant，請問幾個問題。托尼，你強調了這一點——我想你說全球有 2800 萬人患有 RCC。但我想知道，是否有特定的患者亞群和市場上可能最適合這種疾病的藥物治療，也許是更嚴重的患者。然後我想知道您是否願意討論您可能針對此資產設定的潛在銷售高峰期？我可能只是 [圖表] 最後一個。默克的[競爭]顯然面臨著這個領域的宣傳衡量問題。您對您在這裡的資產不會遭遇同樣的命運有多大信心？

Thanks very much Kerry, so this is Camlipixant, obviously, delighted to have announced the deal with BELLUS. And I'm going to ask Luke to pick up on the dimensions of opportunities in subgroups, I mean it's 28 million, but there are more than 10 million who have been living with this for more than a year. So we are very excited about the best-in-class potential and a meaningful contribution that will come after '26 launch. But Luke, I know you've been very impressed with all of us from the beginning. So perhaps you could comment on the relative competitiveness...

非常感謝 Kerry，所以這就是 Camlipixant，顯然很高興宣布與 BELLUS 的交易。我要請盧克了解子群體中機會的維度，我的意思是它有 2800 萬，但有超過 1000 萬人已經忍受了一年多。因此，我們對 26 年發布後的同類最佳潛力和有意義的貢獻感到非常興奮。但是盧克，我知道你從一開始就對我們所有人印象深刻。所以也許你可以評論相對競爭力......

Sure, thanks, and thanks Kerry. Look, I think the important thing here is there's a temptation to focus on the 28 million. So that's all people that technically had cough for more than 8 weeks. But in our modeling of the peak sales and the uptake, we concentrated exactly to your point on subgroups. So people who have had refractory cough for longer than 1 year, so they're more likely to present at a pulmonologist. And then we've taken various other cuts around access, compliance, et cetera. And then you get -- as we put in our slides announcing the deal, it's about 3.3 million potential patients in the U.S. and around 3 million in Europe and about half of that in Japan. So it's quite a sizable group. And what is interesting when you look at numbers being managed right now by pulmonologists, it's about 1.8 million patients being managed right now by pulmonologists in the U.S. with RCC. Now the true number is actually higher because many of them, unfortunately, are sent back to the primary care unfortunately because there's limited options in terms of resolving that. So that's why we think this is a multibillion product. And what I would encourage you to do is if you have discussions with physicians treating these patients. There are 2 things I'll tell you. One frustration in terms of the options available. And then secondly, unprompted, they'll remark on the large volumes of patients that they see. And so you assemble all these things, it's a very compelling asset. I think, versus Merck, I'll let Tony comment on the filing, but the pharmacological profile and the selectivity around P2X3 versus P2X2. This is an incredibly durable, robust differentiation even if we have equivalent efficacy. And of course, the upside is that we have an edge on efficacy versus Merck. But the tox profile is just so much more compelling for the Merck product. And then again, that's the third thing that physicians make a point around in terms of the class. Tony?

當然，謝謝，謝謝 Kerry。看，我認為這裡重要的是有一種關注 2800 萬的誘惑。所以這就是技術上咳嗽超過 8 週的所有人。但是在我們對銷售高峰期和吸收率的建模中，我們完全集中在您對子組的觀點上。因此，頑固性咳嗽超過 1 年的人更有可能去看肺科醫生。然後我們在訪問、合規性等方面採取了其他各種削減措施。然後你會得到——正如我們在宣布交易的幻燈片中所說，美國大約有 330 萬潛在患者，歐洲大約有 300 萬，日本大約有一半。所以這是一個相當大的群體。有趣的是，當您查看目前由肺科醫生管理的數字時，美國的肺科醫生正在使用 RCC 管理大約 180 萬患者。現在真實數字實際上更高，因為不幸的是，他們中的許多人不幸被送回初級保健機構，因為解決這個問題的選擇有限。所以這就是為什麼我們認為這是一個價值數十億的產品。如果您與治療這些患者的醫生進行討論，我會鼓勵您這樣做。我會告訴你兩件事。可用選項方面的一種挫敗感。其次，他們會自發地評論他們看到的大量患者。因此，您將所有這些東西組合在一起，這是一項非常引人注目的資產。我認為，與默克相比，我會讓 Tony 對申請發表評論，但 P2X3 與 P2X2 的藥理學特徵和選擇性。即使我們具有同等功效，這也是一種令人難以置信的持久、穩健的差異化。當然，好處是我們在療效方面比默克有優勢。但是，對於默克產品而言，毒性概況更具吸引力。再一次，這是醫生在課程方面提出的第三點。托尼？

Yes. Luke, just to underscore that point, 2 things about the Merck comparison. Tp put some numbers around selectivity, the unpleasant taste Dysgeusia, which is a significant impact on patients discontinuing therapy is driven by selectivity over the P2X2 receptor class, for which Camlipixant has a 1,500-fold margin. That's an enormous margin relative to the class and of the order of 15x greater than the Merck molecule. So we're very confident in our ability to improve on side effects with regards to that particular selectivity. And indeed, you see that in the Phase II studies, where there's only a 6% incidence of Dysgeusia that can impact exit. The other issue is with regards to a data treatment or analysis issue associated with the cough countering device. We have exactly the same device and approach as Merck. As far as we can tell, their CRL was based on the methodology used to -- for data analysis, where we are on ongoing conversations with the regulator, and we're confident that we will be able to work through that data treatment issue, particularly given the medical need for this area that Luke emphasized.

是的。盧克，只是為了強調這一點，關於默克比較的兩件事。 Tp 圍繞選擇性給出了一些數字，令人不快的味覺障礙對患者停止治療有重大影響，這是由對 P2X2 受體類別的選擇性驅動的，Camlipixant 對此有 1,500 倍的餘量。相對於同類產品而言，這是一個巨大的差距，比默克分子大 15 倍。因此，我們對改善特定選擇性方面的副作用的能力非常有信心。事實上，你在 II 期研究中看到，只有 6% 的味覺障礙發生率會影響退出。另一個問題是關於與止咳設備相關的數據處理或分析問題。我們擁有與默克完全相同的設備和方法。據我們所知，他們的 CRL 基於用於數據分析的方法，我們正在與監管機構進行持續對話，我們相信我們將能夠解決該數據處理問題，特別是考慮到盧克強調的這一領域的醫療需求。

So next question is from Steve Scala.

那麼下一個問題來自 Steve Scala。

Can you hear me?

你能聽到我嗎？

Yes.

是的。

First, I'd like to clarify, when does GSK plan to initiate Phase III trials in adults and infants for the 24 valent pneumococcal vaccine? It is still listed as a 2024 readout. But it's not identified as a catalyst any longer in 2024.

首先，我想澄清一下，葛蘭素史克計劃什麼時候在成人和嬰兒中啟動24價肺炎球菌疫苗的III期試驗？它仍被列為 2024 讀數。但到 2024 年，它不再被確定為催化劑。

All right, so straight to Luke then.

好吧，那就直接說盧克吧。

Yes. So we will start the Phase III study for adults with the pneumococcal 24 valent vaccine at the beginning of next year. That represents an acceleration relative to the acquisition objectives, you have noted that we have a clause in our 24-valent infant program. This is associated with an audit finding with regards to the full finishing presentation of the vaccine. We are still very confident in the overall profile of the vaccine. In fact, our confidence in the technology continues to grow as we see emerging data from competitors in the field. So I'm very confident with progression here. We're working to get the 24 valent infant vaccine study back on track as soon as possible.

是的。因此，我們將在明年年初開始對成人使用肺炎球菌 24 價疫苗進行 III 期研究。這代表了相對於收購目標的加速，你已經註意到我們的 24 價嬰兒計劃中有一個條款。這與關於疫苗完整展示的審計結果有關。我們對疫苗的整體情況仍然非常有信心。事實上，隨著我們看到來自該領域競爭對手的新興數據，我們對該技術的信心不斷增強。所以我對這裡的進展非常有信心。我們正在努力讓 24 價嬰兒疫苗研究盡快回到正軌。

So the next question is from Graham Parry, Bank of America.

所以下一個問題來自美國銀行的 Graham Parry。

So firstly, just on RSV vaccine, just any kind of level of confidence you can give over the likelihood of approval into the AdCom next week. And in particular, given Barré syndrome is obviously raised in both the AdCom and the ASA meeting, so whether there's been any further requests or data or information relating to that? And then secondly, the timing of the 2-season data. I think you said data collection ongoing and update midyear. But how has the FDA requested to see any of that data? And do you think you'll have that data in time for the June ACIP meeting? And how does that play into pricing decisions ahead of launch? So if you have that data, but it's not part of a June ACIP recommendation, can you price this for a 2-year vaccine at the outset? Or are you going to have to start thinking about sort of adjusting pricing post launch, for example?

因此，首先，就 RSV 疫苗而言，您可以對下週獲得 AdCom 批准的可能性給予任何程度的信心。特別是，鑑於在 AdCom 和 ASA 會議上都明顯提出了 Barré 綜合症，那麼是否有任何進一步的請求或與此相關的數據或信息？其次，2 賽季數據的時間。我想你說過正在進行數據收集並在年中更新。但是 FDA 是如何要求查看這些數據的呢？您認為您會在 6 月的 ACIP 會議上及時獲得這些數據嗎？這對發布前的定價決策有何影響？因此，如果您有該數據，但它不是 6 月 ACIP 推薦的一部分，您能否在一開始就為 2 年期疫苗定價？還是您將不得不開始考慮調整髮布後的定價，例如？

Thanks Graham. So we'll come to Tony first and then Luke on the specific pricing, recognizing that when you're a week away from going through the regulatory process announcing what's going to happen we'll have very clear specificity on that. And likewise, in a competitive situation on pricing, but both of those we should respond to too.

謝謝格雷厄姆。因此，我們將首先與 Tony 和 Luke 討論具體定價，並認識到當您距離通過監管程序宣布將要發生的事情還有一周的時間時，我們將對此有非常明確的具體規定。同樣，在價格競爭激烈的情況下，我們也應該對這兩種情況做出回應。

Yes. Where I might start James, is just emphasizing the profile of our vaccine. I'm sure you will recall, particularly with regards to the at-risk populations with regards to hospitalization, where we see 95 -- 94% vaccine efficacy. That profile for efficacy and the overall safety profile, of course, was recognized in the (inaudible) vaccine, which we're delighted to see. We continue to randomize patients on the Phase III study. We randomized it for the second season to receive second vaccination and placebo, which gives us the opportunity to make an appropriate comparison with regards to second season data. I'll remind you in the first season that our data acquisition is determined by event rate, for the second season is determined by the close of the season. And we remain on track to acquire that data, along with other data that we are building the picture for the quality of our vaccine in particular, data for (inaudible) and we'll be moving into the high dose in adjuvanted setting. Again, I'd remind you that on the basis of data we have so far, we are the only vaccine for which (inaudible) shows no impact on the performance of either vaccine. We're also adding data from the At-Risk 50 to 59 population. We expect to have all of those data head of ACIP, as Emma indicated. And Luke, perhaps I can hand over to you with regards to the question for pricing.

是的。我可能會從 James 開始，只是強調我們疫苗的概況。我相信你會記得，特別是關於住院方面的高危人群，我們看到 95 - 94% 的疫苗效力。當然，這種有效性和整體安全性的概況在（聽不清）疫苗中得到了認可，我們很高興看到這一點。我們繼續對 III 期研究中的患者進行隨機分組。我們在第二季將其隨機接受第二次疫苗接種和安慰劑，這讓我們有機會對第二季數據進行適當的比較。我會在第一季提醒大家，我們的數據獲取是由事件率決定的，因為第二季是由賽季結束決定的。我們仍在按計劃獲取這些數據，以及我們正在為我們的疫苗質量構建圖片的其他數據，特別是（聽不清）的數據，我們將在佐劑設置中進入高劑量。我再次提醒您，根據我們目前掌握的數據，我們是唯一一種（聽不清）對任何一種疫苗的性能都沒有影響的疫苗。我們還添加了 50 至 59 歲高危人群的數據。正如 Emma 所指出的，我們希望擁有 ACIP 的所有這些數據負責人。盧克，關於定價問題，也許我可以交給你。

Yes. Thanks, Tony. Thanks Graham. And to reinforce, I mean Tony and his team are incredibly focused on this time line. So our working assumption is that we have that in an unusual scenario that we just missed a deadline. As I said, we do not expect. I think it would depend on the robustness of the signal. But my working assumption is if we had that second season, then we would price it at the upper end of the range. And we've signaled in the past, that the range is -- at the time were between high-dose flu, which is in the 60s and Shingrix, which is [185]. Of course, it's now moving more towards the right-hand side of that midpoint. And if we had that second season, then we'd be very much on the right-hand side of that midpoint.

是的。謝謝，托尼。謝謝格雷厄姆。為了加強，我的意思是托尼和他的團隊非常專注於這條時間線。所以我們的工作假設是，在一個不尋常的情況下，我們剛剛錯過了最後期限。正如我所說，我們不期望。我認為這取決於信號的穩健性。但我的工作假設是，如果我們有第二季，那麼我們會將其定價在該範圍的上限。我們過去曾表示，範圍是——當時介於 60 年代的高劑量流感和 [185] 的 Shingrix 之間。當然，它現在更靠近中點的右側。如果我們有第二個賽季，那麼我們就會非常處於中點的右側。

So next question is from Richard Parkes at BNP Paribas.

那麼下一個問題來自法國巴黎銀行的理查德帕克斯。

Nick, hopefully, you can hear me okay. Just got 2 questions. Firstly, on Shingrix. I just wondered if you could disclose what underlying U.S. volume demand growth was when you ex out the stocking differences? And maybe you could just update us on ex U.S. launches where you're seeing most traction and how that will evolve through the year. Then second question was for Tony on business development and R&D. Many of the recent transactions have added late-stage programs such as momelotinib, Camlipixant that will help cushion patent expiries that you'll experience later in the decade. But they don't necessarily bring platforms or technology that can help to improve GSK's longer-term R&D productivity. So my question for Tony is now that he's been in the seat a little bit longer, if he feels confident GSK has invested in enough through business development to retool the company in terms of technology platforms and capability for it to be competitive and improve internal R&D productivity longer term?

尼克，希望你能聽到我的聲音。剛有2個問題。首先，關於 Shingrix。我只是想知道當你排除庫存差異時，你是否可以透露美國潛在的銷量需求增長是多少？也許你可以向我們介紹你最有吸引力的前美國發射以及它在這一年中將如何發展。然後第二個問題是關於業務發展和研發的問題。最近的許多交易都增加了後期項目，如 momelotinib 和 Camlipixant，它們將有助於緩衝您將在十年後遇到的專利到期。但他們不一定會帶來有助於提高 GSK 長期研發生產力的平台或技術。所以我要問托尼的問題是，現在他在位時間稍長了一點，他是否有信心葛蘭素史克通過業務發展進行了足夠的投資，以在技術平台和能力方面重組公司，使其具有競爭力並改善內部研發長期生產力？

Thanks very much Richard and obviously, I'll ask Luke to comment on Shingrix, but we still see a lot of growth ahead. And then we'll come to Tony. I mean we remain -- you said is it a redundant we need to. This is always an ongoing piece of work and it's always at the core of our strategy in R&D. And you're absolutely right, we are focused both on assets and on platforms, but Tony can make some more specific commentary on where we're at. But Luke to lead the conversation onto ...

非常感謝 Richard，顯然，我會請 Luke 對 Shingrix 發表評論，但我們仍然看到未來有很大的增長。然後我們會來找托尼。我的意思是我們仍然存在——你說我們需要這樣做是多餘的嗎？這始終是一項持續的工作，它始終是我們研發戰略的核心。你是對的，我們既關注資產又關注平台，但托尼可以就我們所處的位置發表一些更具體的評論。但是盧克將談話引向......

Thanks Richard in terms of the market research, if we look at pharmacists, Shingrix is now our #1 priority and some of the challenges that they had around staffing and elements like that have been resolved. If we look at primary care physicians and intention to recommend vaccine, again, it remains unchanged. So all of those things are pointing in the right direction. If we look at TRxs, then over 60% of them are first dose, which again is very consistent. So these are all encouraging elements. In terms of Q1, it was influenced by 2 distinct events, which I think will start to be washed through in Q2. The first one was, we had an inventory unwind versus Q1 '22. So in Q1 '22, it was 0.9%. This quarter, it was 0.6%. And as we've discussed on lots of course before, even the steady state is around 1 to 2 million doses a month. So we expect and there are signs that, that's normalizing now. And then the other thing is linked to that, the strength of retail is very much driven by the 65 and above, which you would expect with the removal of the co-pay. As you know, commercial patients don't have a co-pay. And then the second element influencing this is that we had a lower nonretail quarter 1 performance due to a very specific element, which I won't go into, but it is thoroughly addressable, and we expect to recover those patients in Q2. So you put those 2 things together, that's what explains the numbers. But as I said, very strong. If we look ex-U.S., yes, 39% of the growth, we continue to pick up reimbursement decisions. We've got expansion in Japan. We've just picked up Australia and a number of markets in Europe. We're now really starting to get traction on. Early days in China in terms of the recovery. And then, of course, in the long term, we're very focused on the booster in the IC population, but also potentially people with an additional co-morbidity to come back and rechallenge the original cohort.

感謝理查德在市場研究方面，如果我們看看藥劑師，Shingrix 現在是我們的第一要務，他們在人員配置和類似要素方面遇到的一些挑戰已經得到解決。如果我們再看看初級保健醫生和推薦疫苗的意圖，它仍然保持不變。所以所有這些事情都指向正確的方向。如果我們看一下 TRx，那麼其中超過 60% 是第一劑，這又是非常一致的。所以這些都是令人鼓舞的因素。就第一季度而言，它受到 2 個不同事件的影響，我認為這些事件將在第二季度開始受到影響。第一個是，與 22 年第一季度相比，我們進行了庫存平倉。所以在 22 年第一季度，它是 0.9%。本季度為 0.6%。正如我們之前討論過的很多課程一樣，即使是穩定狀態，每月也有 1 到 200 萬劑左右。所以我們預計並且有跡象表明，現在正在正常化。然後另一件事與此相關，零售的實力在很大程度上是由 65 歲及以上的人推動的，你會在取消共同支付後預料到這一點。如您所知，商業病人沒有共付額。然後影響這一點的第二個因素是，由於一個非常具體的因素，我們第一季度的非零售業績較低，我不會深入討論，但它是完全可以解決的，我們希望在第二季度恢復這些患者。所以你把這兩件事放在一起，這就是解釋數字的原因。但正如我所說，非常強大。如果我們看看美國以外的地區，是的，增長的 39%，我們將繼續做出報銷決定。我們在日本有擴張。我們剛剛收購了澳大利亞和歐洲的一些市場。我們現在真的開始受到關注。就復甦而言，中國處於早期階段。然後，當然，從長遠來看，我們非常關注 IC 人群中的助推器，但也可能有額外合併症的人回來重新挑戰原來的隊列。

Great. And then in terms of technology platforms, I'm delighted with the platform access we have and the progress we're making. I might start actually in the vaccines area and refer again to Affinivax, which I feel is the leading protein complexation technology that's available. We're obviously making great progress in our partnership with CureVac and with regards to RNA, and you saw some of the data that was exciting us in Phase I at least in the context of (inaudible) covered earlier in the year. Add that to our already existing capacity in vaccines to protein subunit structure-based vaccine design and adjuvants illustrated nicely to the RSV vaccine that we've just been talking about. And I think we're in an extremely solid position with regards to vaccines technologies. You'll remember that we added -- in the medicines part of our business, we added access to what we believe is the strongest oligonucleotide platform at the moment in the context of a multi-target deal with Wave Therapeutics. So as far as what I would refer to as platform technologies, I think we're in excellent position. We obviously, as Emma indicated, remain vigilant in further areas of development. In data technology, I would add collaborations like the one that we signed with Tempus recently, which will be about helping us to identify patients in oncology and to spot the right combinations. Obviously, they go on top of on existing collaborations in data and human genetics and functional genomics like 23andMe and LGR, for example, giving us access to cutting-edge technology. So I think we're extremely well placed across the board with regards to both platform and data technology, although you will continue to see that as a theme of business development as I look to augment capabilities when appropriate target identification and needs merge in the portfolio.

偉大的。然後在技術平台方面，我對我們擁有的平台訪問權限和我們正在取得的進展感到高興。實際上，我可能會從疫苗領域開始，並再次提到 Affinivax，我認為它是可用的領先蛋白質絡合技術。顯然，我們在與 CureVac 的合作夥伴關係以及 RNA 方面取得了很大進展，你在第一階段看到了一些令我們興奮的數據，至少在今年早些時候報導的（聽不清）背景下。將其添加到我們現有的疫苗能力中，以基於蛋白質亞基結構的疫苗設計和佐劑很好地說明了我們剛剛談到的 RSV 疫苗。我認為我們在疫苗技術方面處於非常穩固的地位。你會記得我們添加了——在我們業務的藥物部分，在與 Wave Therapeutics 的多目標交易的背景下，我們增加了對我們認為目前最強大的寡核苷酸平台的訪問。因此，就我所說的平台技術而言，我認為我們處於有利地位。正如 Emma 所指出的，我們顯然對進一步的發展領域保持警惕。在數據技術方面，我想增加合作，比如我們最近與 Tempus 簽署的合作，這將幫助我們識別腫瘤學患者並發現正確的組合。顯然，他們超越了現有的數據和人類遺傳學以及功能基因組學合作，例如 23andMe 和 LGR，使我們能夠獲得尖端技術。因此，我認為我們在平台和數據技術方面都處於非常有利的位置，儘管您將繼續將其視為業務發展的主題，因為我希望在適當的目標識別和需求合併到投資組合中時增強功能.

So next question is from Andrew Baum with Citi.

那麼下一個問題來自花旗的安德魯鮑姆。

A couple of questions. First for Deborah on ViiV. Could you talk to the anticipated impact of the rollback on continuous enrollment under Medicaid on ViiV. My assumption is the economic impact for the group is going to be limited because of the lower profitability and programs like Ryan White will plug the gap as anyone loses coverage. But if you could tell me if those assumptions are incorrect. And then second, for Luke, you've spoken about the potential for line agnostic indication for momelotinib in MFS. We're waiting obviously the label I'm sure the NCCN has already reviewed the data, assuming that you do get line agnostic approval. Do you have any sense to which category recommendation NCCN will rate if you are to challenge Jakafi in that setting?

幾個問題。首先是 ViiV 上的 Deborah。您能否談談回滾對 ViiV 醫療補助下持續註冊的預期影響。我的假設是，由於較低的盈利能力和 Ryan White 等計劃將填補該集團的經濟影響，因為任何人都失去了保險。但如果你能告訴我這些假設是否不正確。其次，對於 Luke，您談到了 MFS 中 momelotinib 的線不可知適應症的潛力。我們顯然在等待標籤，我相信 NCCN 已經審查了數據，假設您確實獲得了與生產線無關的批准。如果您要在那種情況下挑戰 Jakafi，您是否知道 NCCN 會給哪個類別推薦評級？

All right over to you Deborah?

好吧，黛博拉？

Great. Thanks Andrew. So I think you're talking about the Braidwood ruling when you're talking about some of the challenges externally in the environment, so if not stop me. But basically, the Affordable Care Act mandates coverage by commercial payers, so that they cover preventative services without cost sharing, which is very, very important. A number of employees with strong religious beliefs don't want commercial insurers to cover drug in HIV a judge in Texas found in favor of the plaintiffs. And therefore, the Biden administration has actually appealed against this judgment because actually, it doesn't just tackle HIV for PrEP, but actually, it's really undermining one of the core claims of the Affordable Care Act that preventative services would be covered by commercial insurers. So it's got a number of different layers and that court case, which I think will go all the way up to the Supreme Court, probably going to take a couple of years. So from our perspective, there's 2 things. We don't think there's going to be short-term impact. We're going to watch and wait to see what happens in the court case. But also, obviously, we work very closely with the community and with the various bodies in the kind of the U.S. administration. And their view is that they are going to put in place policy and other reforms to ensure that the Affordable Care Act mandate around prevention remains in place because of their commitment to it. The other thing that's slightly ironic here is obviously, the government -- and in fact, it's [harder] on the commitment to ending the HIV epidemic has set a goal of ensuring that 50% of people who are eligible for PrEP. So that's about 600,000 people of the 1.2 million who were at risk should be prescribed PrEP by 2025. So it's not just butting up against the Affordable Care Act mandate, but it's also undermining the ending the HIV epidemic initiative, which is why we know from all of our government partners now are going to fight to maintain this very strongly and they've got some clear things that they're going to do from a policy perspective and there are furlough options to make sure this isn't impacting their mandates. So for me, it's a watch and wait, but I'm not expecting any short- to medium-term impact. Let's see how it plays out.

偉大的。謝謝安德魯。所以我認為當你談論環境中的一些外部挑戰時，你是在談論 Braidwood 裁決，所以如果不阻止我的話。但基本上，《平價醫療法案》要求商業付款人提供保險，這樣他們就可以在不分攤費用的情況下提供預防性服務，這非常非常重要。許多具有強烈宗教信仰的員工不希望商業保險公司承保 HIV 藥物，德克薩斯州的一名法官裁定原告勝訴。因此，拜登政府實際上已經對這一判決提出上訴，因為實際上，它不僅針對 PrEP 解決艾滋病毒問題，而且實際上，它確實破壞了《平價醫療法案》的核心主張之一，即預防服務將由商業保險公司承保.所以它有很多不同的層次和那個法庭案件，我認為這將一直到最高法院，可能需要幾年時間。所以從我們的角度來看，有兩件事。我們認為不會產生短期影響。我們將拭目以待，看看法庭案件中會發生什麼。而且，很明顯，我們與社區以及美國政府中的各種機構密切合作。他們的觀點是，他們將實施政策和其他改革，以確保平價醫療法案圍繞預防的授權仍然存在，因為他們對此做出了承諾。另一件有點諷刺的事情顯然是，政府——事實上，它 [更難] 承諾結束艾滋病毒流行已經設定了一個目標，即確保 50% 的人有資格獲得 PrEP。因此，到 2025 年，在 120 萬處於危險中的人中，大約有 600,000 人應該接受 PrEP 處方。因此，這不僅違反了《平價醫療法案》的規定，而且還破壞了結束艾滋病流行的倡議，這就是為什麼我們從我們所有的政府合作夥伴現在都將努力保持這一點，並且他們已經從政策角度明確了他們將要做的事情，並且有休假選擇以確保這不會影響他們的任務。所以對我來說，這是一個觀察和等待，但我預計不會產生任何短期到中期的影響。讓我們看看結果如何。

Thanks, Deborah. So Luke, momelotinib?

謝謝，黛博拉。那麼盧克，莫美洛替尼？

Yes. Thanks Andrew. And as you know, the base case for the deal was second-line anemia patients who are JAK-exposed with anemia, anything if we did get a first-line label there's clearly an upside there. I will have to bite my tongue. I don't want to speculate because you can imagine, we're in discussions with a number of people right now. What I can tell you is that we are very clearly stating that momelotinib, of course, is the only agent with profound clinical and a durable benefit in terms of [spleen results] and symptom relief with patients with anemia. I think that is landing incredibly well. If we look at unaided awareness coming out of ASH, it's quite striking. It's around 32%, which is double the typical benchmark in hematology. And when you look at aided awareness it's around 75% of physicians. And what is also interesting, we're not actively out there making this point, but already, you've got 60% of treating physicians indicate that one of the top 3 reasons that they switch patients because of issues with anemia and transfusion. So it's a very fertile environment for us to arrive in, and we're hoping that the NCCN recognize that in terms of the labeling and language in the guidelines.

是的。謝謝安德魯。正如你所知，這筆交易的基本案例是二線貧血患者，他們患有 JAK 暴露於貧血，如果我們確實獲得了一線標籤，那顯然有好處。我將不得不咬住我的舌頭。我不想推測，因為你可以想像，我們現在正在與很多人討論。我可以告訴你的是，我們非常明確地指出，莫美羅替尼當然是唯一在 [脾臟結果] 和貧血患者症狀緩解方面具有深遠臨床和持久益處的藥物。我認為這著陸得非常好。如果我們觀察來自 ASH 的獨立意識，那將是非常驚人的。它約為 32%，是血液學典型基準的兩倍。當您查看輔助意識時，大約有 75% 的醫生使用。同樣有趣的是，我們並沒有積極地提出這一點，但已經有 60% 的主治醫生表示，他們更換患者的三大原因之一是貧血和輸血問題。因此，對於我們來說，這是一個非常肥沃的環境，我們希望 NCCN 在指南中的標籤和語言方面認識到這一點。

Yes. Very much looking forward to that launch.

是的。非常期待那次發射。

We've got 8 minutes left. I'm mindful that there is another call starting at 1 O'clock, so if you can keep your questions short that would obviously be appreciated. So...

我們還有 8 分鐘。我注意到還有另一個電話從 1 點開始，所以如果您能簡短地提問，我們將不勝感激。所以...

Like the answer too.

也喜歡這個答案。

Exactly. James, back to you at JPMorgan, please.

確切地。詹姆斯，請回到摩根大通。

James Gordon, JPMorgan. Two questions. One on Zantac and one on M&A. Sort of linked together though, the Zantac said that the Sargon hearing wasn't quite as positive as the [MDL] but latest thoughts on what that could mean in terms of liability and when this all could get wrapped up by? And given the need to maybe have some funds to address any potential anti damages, are you a bit (inaudible) on BD for a while? Is there still room to do much more BD? Or do you have to set aside some funds there? Could you put the Helion strike to work? Could you sell that? So then you've got the ability to do some more BD. And the second question also on BD if I may (inaudible).

詹姆斯戈登，摩根大通。兩個問題。一篇關於 Zantac，一篇關於併購。雖然有點聯繫在一起，但 Zantac 表示薩爾貢聽證會並不像 [MDL] 那樣積極，但關於這在責任方面可能意味著什麼以及這一切何時可以結束的最新想法？考慮到可能需要一些資金來解決任何潛在的反損害，您是否有一段時間（聽不清）在 BD 上？還有做更多BD的空間嗎？或者你必須在那裡預留一些資金？你能讓 Helion 罷工發揮作用嗎？你能賣掉那個嗎？那麼你就有能力做更多的 BD。如果可以的話，第二個問題也是關於 BD 的（聽不清）。

I think that was 3 but yes.

我認為那是 3，但是是的。

(inaudible) which is a therapeutic strategy. I think it was more oncology. And then I thought the focus was more infectious disease. But BELLUS, to me, looks a bit more like general meds respiratory. It could be more of a focus now?

（聽不清）這是一種治療策略。我認為這是更多的腫瘤學。然後我認為重點是更多的傳染病。但是，對我來說，BELLUS 看起來更像是普通的呼吸道藥物。它現在可能更受關注？

There's absolutely no change in our focus here, James. But let me try and succinctly respond to that. So first of all, no news, new news on Zantac, very confident in our position. Obviously, respectfully disagree with the conclusion in California. We're going to work through that case that's coming up in the summer, delighted with the federal dismissal at the end of last year and continue to defend our position vigorously. The independence of that BD remains absolutely core in terms of our R&D strategy. It is part of the way like the rest of the industry that we do R&D. It's been one of the biggest changes we've driven in the company over the last few years, delighted with the deals that we've announced recently. And as you alluded to, it is absolutely core to the structural transformation that we've made of this company with the demerger of Helion, the resetting of the balance sheet, the new step change in operating performance to generate more cash and obviously, competitive for appropriate distributions direct to shareholders as well, which is creating all of this capacity, which we are deploying we think smartly in ways with a lot of financial discipline that contributed meaningfully toward growth. We are confident of great momentum this year, the 5-year outlook, and we're really looking forward to adding to that the growth ahead. And there is total consistency in terms of what we've said we are prioritizing in terms of our BD. That is vaccines and specialty meds as the core priorities. That doesn't mean we haven't taken advantage, particularly in building out our anti-infective priority because we are -- we do have expertise in infectious disease and it's such a core global unmet need, the side of pandemic that will kill 10 million people a year. If the industry doesn't address antibiotics. We've got a nice set of tuck-ins that Luke has led for us there. But the core priority is vaccines and specialty assets and platforms and within our TAs, 4 that we work on infectious diseases, HIV, immunology and respiratory and, of course, oncology, which is a small but emerging area for us where we've been pragmatic, and we'll just talk about momelotinib which we're excited about coming up. So hopefully, that covers all of your questions. And the next one, please.

詹姆斯，我們的重點絕對沒有改變。但讓我試著簡明扼要地回應一下。所以首先，沒有消息，關於 Zantac 的新消息，對我們的立場非常有信心。顯然，恭敬地不同意加州的結論。我們將處理今年夏天即將到來的案件，對去年年底聯邦解僱感到高興，並繼續大力捍衛我們的立場。就我們的研發戰略而言，BD 的獨立性絕對是核心。這是我們進行研發的方式的一部分，就像我們從事研發的其他行業一樣。這是過去幾年我們在公司推動的最大變革之一，對我們最近宣布的交易感到高興。正如你提到的，這絕對是我們對這家公司進行的結構轉型的核心，包括 Helion 的分拆、資產負債表的重置、經營業績的新步驟變化以產生更多現金，顯然，具有競爭力對於直接向股東進行適當的分配，這正在創造所有這些能力，我們正在部署我們以許多財務紀律的方式巧妙地思考，這對增長做出了有意義的貢獻。我們對今年的強勁勢頭、5 年展望充滿信心，我們真的很期待未來的增長。我們所說的 BD 優先事項完全一致。那就是疫苗和特殊藥物作為核心優先事項。這並不意味著我們沒有利用優勢，特別是在建立我們的抗感染優先事項方面，因為我們 - 我們確實擁有傳染病方面的專業知識，這是全球未滿足的核心需求，大流行的一面將殺死 10萬人每年。如果該行業不解決抗生素問題。我們有一套很好的便衣，盧克在那里為我們帶頭。但核心優先事項是疫苗和專業資產和平台，在我們的助教 4 內，我們致力於傳染病、艾滋病毒、免疫學和呼吸系統，當然還有腫瘤學，這對我們來說是一個很小但新興的領域務實，我們將只談論我們很高興出現的 momelotinib。希望這涵蓋了您所有的問題。下一個，請。

So next question is going to come from Seamus Fernandez at Guggenheim.

所以下一個問題將來自古根海姆的 Seamus Fernandez。

Yes. I'm just getting the instructions on how to unmute. So just one question. I really wanted to get a sense of the company strategy in flu with mRNA and how you're thinking about the competitive landscape? We just got some, I guess, mixed data from competitor Moderna at their recent vaccines day, but we'll get some additional data in the back half of this year. So just love to see how you're thinking about the mRNA flu opportunity for GSK and what you're seeing as it relates to the competitive landscape?

是的。我剛剛收到有關如何取消靜音的說明。所以只有一個問題。我真的很想了解公司在 mRNA 流感方面的戰略，以及你如何看待競爭格局？我猜，我們剛剛在最近的疫苗日從競爭對手 Moderna 那裡得到了一些混合數據，但我們將在今年下半年獲得一些額外的數據。因此，很想看看您如何看待 GSK 的 mRNA 流感機會，以及您所看到的與競爭格局相關的內容？

Sure. Well, I mean, let's start by saying we're excited about mRNA technology, the early data and we expect to continue to invest more in mRNA as a portfolio. I think as to the competitive landscape, maybe, Luke, you could just comment a little bit on how you see that?

當然。好吧，我的意思是，讓我們首先說我們對 mRNA 技術、早期數據感到興奮，我們希望繼續對 mRNA 作為一個投資組合進行更多投資。我認為關於競爭格局，也許，盧克，你可以談談你的看法嗎？

Sure. So I mean, as you know, we have no presence in high dose. So anything that we can extract and penetrate there is upside. Our working assumption is that there will be a tolerable mRNA vaccine developed. And of course, we have the partnership with CureVac. I think the advantage of mRNA, of course, is just the speed at which you can go from bench to the clinic. And that is not relevant for areas like Shingles, but it is profoundly relevant when you're seeking to select strains and predict a future season. And so any compression enabling greater certainty in terms of the leading hemisphere to select those strains is going to produce a more effective vaccine and hopefully shift it above 50% that we see in a typical year. So our working assumption is it's going to be very disruptive. And I think the combination of COVID in the partnership with CureVac is also a very attractive. And our expectation is that the urgency around COVID is going to be reduced, but flu is going to be durable. And therefore, 2 plus 1 vaccine is attractive. I don't know, Tony, if you want to mention anything in terms of the program that we've got.

當然。所以我的意思是，如你所知，我們沒有高劑量存在。因此，我們可以提取和滲透的任何東西都有好處。我們的工作假設是將開發出一種可耐受的 mRNA 疫苗。當然，我們與 CureVac 建立了合作夥伴關係。我認為 mRNA 的優勢當然只是您從實驗室到臨床的速度。這與帶狀皰疹等領域無關，但當您尋求選擇菌株並預測未來季節時，它具有深遠的意義。因此，任何能夠在選擇這些毒株的主要半球方面提供更大確定性的壓縮都將產生更有效的疫苗，並有望將其提高到我們在典型年份看到的 50% 以上。所以我們的工作假設是它會非常具有破壞性。而且我認為 COVID 與 CureVac 的合作夥伴關係也非常有吸引力。我們的期望是，圍繞 COVID 的緊迫性將會降低，但流感將持續存在。因此，2加1疫苗很有吸引力。托尼，我不知道你是否想就我們的計劃提及任何事情。

Yes. Just to underscore the point that Emma made at the beginning, if we look at the developments in mRNA in the field in general, I think they're all adding up to the need and importance to secure therapeutic index with regards to the gap between immunogenicity and reactogenicity. And as I mentioned earlier, the data that we disclosed or our partner CureVac disclosed earlier this year, I think give us a good start with regards to expectations of both sequence modification and use of modifying basis are going to give us a strong position.

是的。只是為了強調 Emma 在開始時提出的觀點，如果我們從總體上看 mRNA 在該領域的發展，我認為它們都加起來證明了在免疫原性之間的差距方面確保治療指數的必要性和重要性和反應原性。正如我之前提到的，我們披露的數據或我們的合作夥伴 CureVac 今年早些時候披露的數據，我認為在序列修改和修改基礎的使用方面給我們一個良好的開端，這將使我們處於有利地位。

Great. Nick, any time for any more?

偉大的。尼克，還有時間嗎？

Last question. So apologies to those that we weren't able to get to, but our last question comes from Simon Baker at Redburn.

最後一個問題。對那些我們沒能接觸到的人表示歉意，但我們的最後一個問題來自 Redburn 的 Simon Baker。

I'll be brief, but just quickly wanted to get a quick note of thanks in for Iain for all the help and assistance he has given us over the years. Two quick questions. Firstly, on Camlipixant. I just -- although RCC is obviously a very big indication. I just wonder if you could give us any thoughts on potential beyond RCC, given P2X3's implications in areas like overactive bladder and endometriosis. And secondly, on gepotidacin, a fabulous job on the development side. Arguably, the big challenge to come is on commercialization. So Luke, I just wondering if you could give us some thoughts on how you think about selling a new differentiated antibiotic, which historically has been somewhat of a commercial challenge?

我會很簡短，但很快就想快速感謝伊恩多年來為我們提供的所有幫助和幫助。兩個快速問題。首先，關於 Camlipixant。我只是——儘管 RCC 顯然是一個非常大的跡象。鑑於 P2X3 在膀胱過度活動症和子宮內膜異位症等領域的影響，我只是想知道您是否可以給我們關於 RCC 以外的潛力的任何想法。其次，在 gepotidacin 方面，開發方面的工作非常出色。可以說，即將到來的巨大挑戰在於商業化。所以盧克，我只是想知道你是否可以給我們一些關於你如何考慮銷售一種新的差異化抗生素的想法，這在歷史上一直是一個商業挑戰？

It's a great point because I know there's been an enormous amount of thinking from Luke and his team on the (inaudible) across our anti-infectious portfolio, where we are confident we're going to deliver financial returns. So we'll come to you in a moment on this. But perhaps, first, Tony, you can comment on life cycle innovation possibilities on Camlipixant, by the way, also, which is primarily a female patient profile as well in RCC. So in...

這是一個很好的觀點，因為我知道盧克和他的團隊對我們的抗感染產品組合（聽不清）進行了大量思考，我們有信心我們將在這些方面提供財務回報。所以我們稍後會來找你。但也許，首先，托尼，你可以評論 Camlipixant 的生命週期創新可能性，順便說一句，這也主要是 RCC 中的女性患者資料。所以在...

Yes. And look, Simon, first of all, of course, our focus on Camlipixant is, it is an increasing degree of penetration into the enormous unmet need for the 30 million patients that suffer from refractory chronic cough I'm sure you've followed this. If you looked at the colocalization of the P2X3 ligand-gated [ion] channel with regards to sensory reference, you could imagine in utility in pain, migraine during [continents]. But our focus is really to establish the profile of the molecule in Phase III in RCC, where we see the biggest need and immediate opportunity.

是的。看，西蒙，首先，當然，我們對 Camlipixant 的關注是，它越來越多地滲透到 3000 萬患有難治性慢性咳嗽的患者的巨大未滿足需求中，我相信你已經關注了這個.如果您查看 P2X3 配體門控 [離子] 通道在感覺參考方面的共定位，您可以想像它在疼痛、偏頭痛 [大陸] 期間的效用。但我們的重點實際上是在 RCC 的 III 期建立分子概況，我們看到了最大的需求和直接的機會。

Thanks Simon. Yes. And I think we're very excited about the profile that's been achieved in Phase III with Tony's team. If you look at typical broad spectrum antibiotics, they are reserved because as you would expect, people want to retain potency and avoid resistance, there's also incentives around -- in hospital use in terms of DIG disincentives that don't come into play here. And I think that the main argument if someone was to challenge on the risk of resistance is gepotidacin has been developed specifically for pathogens that are resistant in and limited to use in uncomplicated UTI and gonorrhea. So it's not a reagent that's going to be used for postoperative infection, staph, et cetera. So -- and the other problem we have is if you look in the U.S. there is around 15 million episodes a year. About 1/4 of those are recurrent and they're resistant or the patient is allergic or intolerant for 3 or more antibiotics. So this is a growing group. The typical strategy, of course, is to try nitrofurantoin and others, but about 1/4 of these patients -- physicians employ fluoroquinolones which, as you know, are broad spectrum antibiotics. So they're actually contributing to the problem. The argument is displaced fluoroquinolones used gepotidacin which has a much lower risk of resistance. And of course, you're not destroying activity in other pathogens, which could be used for more aggressive infections. And then you've got the commercial scale that we can bring and the logic as Emma's outlined of assembling tebipenem and gepotidacin and Brexafemme is that we get enormous synergy across the specialty groups and the primary doctors that are treating these patients.

謝謝西蒙。是的。我認為我們對托尼團隊在第三階段取得的成就感到非常興奮。如果你看一下典型的廣譜抗生素，它們會被保留，因為正如你所料，人們希望保持效力並避免耐藥性，周圍也有激勵措施——在醫院使用中，就 DIG 抑制因素而言，這裡沒有發揮作用。而且我認為，如果有人要質疑耐藥性風險，主要論點是吉泊達辛是專門針對在無並發症的 UTI 和淋病中具有耐藥性且僅限於使用的病原體而開發的。所以它不是用於術後感染、葡萄球菌等的試劑。所以 - 我們遇到的另一個問題是，如果你看看美國，每年大約有 1500 萬集。其中大約 1/4 是複發性的，並且它們具有耐藥性，或者患者對 3 種或更多種抗生素過敏或不耐受。所以這是一個不斷壯大的群體。當然，典型的策略是嘗試使用呋喃妥因和其他藥物，但這些患者中約有 1/4 - 醫生使用氟喹諾酮類藥物，如您所知，它們是廣譜抗生素。所以他們實際上是在促成這個問題。爭論的焦點是使用 gepotidacin 替代氟喹諾酮類藥物，其耐藥風險要低得多。當然，你並沒有破壞其他病原體的活性，這些病原體可用於更具侵襲性的感染。然後你就得到了我們可以帶來的商業規模，正如 Emma 概述的組裝替比培南和 gepotidacin 和 Brexafemme 的邏輯是，我們在治療這些患者的專業小組和主要醫生之間獲得了巨大的協同作用。

Thanks Nick. All right. So I think that wraps up our call today. Great start to 2023 with all growth drivers performing and good momentum, very focused on the upcoming launches and continue to strengthen our pipeline organically and inorganically, all of which underpins our confidence the outlooks ahead. Thank you, everyone. Speak to you soon.

謝謝尼克。好的。所以我認為我們今天的電話會議到此結束。 2023 年開局良好，所有增長驅動因素都表現良好，勢頭良好，非常關注即將推出的產品，並繼續有機和無機地加強我們的產品線，所有這些都增強了我們對未來前景的信心。謝謝大家。盡快回复你。