葛蘭素史克 (GSK) 2022 Q3 法說會逐字稿

內容摘要

文本描述了公司專注於向患者提供產品,以及對其能力的信心。它還討論了公司在研發方面的投資,以及在 HPV 和埃博拉疫苗方面的進展。 Incyte 是一家專注於腫瘤學的製藥公司。該公司預計此時市場將飽和,除非該變體有所發展。抑制的主要領域仍然是卵巢癌的診斷、手術和治療。該公司專注於免疫腫瘤學和 CD226 軸,以便為癌症治療做出有意義的貢獻。 公司 2022 年第三季度的商業運營營業額為 78 億英鎊,增長 9%。調整後的營業利潤為 26 億英鎊,增長 4%。每股總收益為 18.8 便士,下降 35%,而調整後的每股收益為 46.9 便士,增長 11%。大流行解決方案使調整後的營業利潤增長約 2 個百分點,調整後的每股收益增長約 3 個百分點。演講者正在討論全球艾滋病毒治療市場以及它如何受到 COVID-19 的影響。他們指出,雖然整體市場正在恢復到大流行前的水平,但市場的動態部分仍然受到抑制。演講者將此歸因於 COVID-19 的持續影響。演講者接著說,有真實世界的證據表明 Xevudy 對 BA.2 波 COVID-19 有效。他們認為這一證據可以外推到 BA.5 波。

演講者正在討論全球艾滋病毒治療市場以及它如何受到 COVID-19 的影響。他們指出,雖然整體市場正在恢復到大流行前的水平,但市場的動態部分仍然受到抑制。演講者將此歸因於 COVID-19 的持續影響。演講者接著說,有真實世界的證據表明 Xevudy 對 BA.2 波 COVID-19 有效。他們認為這一證據可以外推到 BA.5 波。 2017 年 10 月,輝瑞公司宣布正在開發一種腦膜炎疫苗。這一消息導致葛蘭素史克股價下跌,因為投資者擔心輝瑞將在市場上佔據優勢。然而,葛蘭素史克有信心,目前正在開發的自己的疫苗將與輝瑞的疫苗一樣有效。

葛蘭素史克是一家成立於 1873 年的英國製藥公司。該公司在開發疫苗方面有著悠久的歷史,目前擁有世界上最大的疫苗組合。葛蘭素史克有信心其腦膜炎疫苗將與輝瑞的一樣有效,並且不認為輝瑞在市場上具有優勢。

葛蘭素史克的首席執行官 Emma Walmsley 對公司與輝瑞競爭的能力充滿信心。她指出了該公司開發疫苗的悠久歷史及其龐大的疫苗組合。她還指出,該公司在疫苗價格方面是靈活的,它的目標是在其他任何人接近推出之前,對市場進行 10 年以上的治療和不斷發展的療效。

完整原文

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

  • Operator

    Operator

  • Good afternoon, ladies and gentlemen, and welcome to the Analyst Call for the GSK Third Quarter 2022 Results.

    女士們,先生們,下午好,歡迎參加 GSK 2022 年第三季度業績分析師電話會議。

  • I will now hand you over to Nick Stone, Head of Global Investor Relations, who will introduce today's session. Nick, please go ahead.

    我現在將把您交給全球投資者關係主管尼克斯通,他將介紹今天的會議。尼克,請繼續。

  • Nick Stone

    Nick Stone

  • Thank you, operator. Hello, everyone. It's Nick, as just mentioned. Welcome to our year-to-date and Q3 2022 conference call and webcast for investors and analysts.

    謝謝你,接線員。大家好。正如剛才提到的,是尼克。歡迎參加我們為投資者和分析師舉辦的年初至今和 2022 年第三季度的電話會議和網絡直播。

  • Earlier today, the presentation was posted to gsk.com. And it was also sent by e-mail to our distribution list.

    今天早些時候,該演示文稿已發佈到 gsk.com。它還通過電子郵件發送到我們的分發列表。

  • Please turn to Slide 2. This is the usual safe harbor statement, and we'll be making comments on our performance using constant exchange rates, or CER, unless stated otherwise.

    請轉到幻燈片 2。這是通常的安全港聲明,除非另有說明,否則我們將使用恆定匯率或 CER 對我們的表現發表評論。

  • As a reminder, the Consumer Healthcare business was demerged on the 18th of July to form Haleon. And as a result, we are today presenting continuing operations for GSK.

    提醒一下,消費者保健業務於 7 月 18 日分拆,成立 Haleon。因此,我們今天將介紹 GSK 的持續運營。

  • Turning to Slide 3. This is today's agenda, where we plan to cover all aspects of our year-to-date and Q3 2022 results. The presentation will last approximately 35 minutes, with around 40 minutes for questions. (Operator Instructions)

    轉到幻燈片 3。這是今天的議程,我們計劃涵蓋我們年初至今和 2022 年第三季度業績的所有方面。演講將持續約 35 分鐘,其中提問時間約為 40 分鐘。 (操作員說明)

  • Today, our speakers are Emma Walmsley, Tony Wood on the phone, Luke Miels, Deborah Waterhouse and Iain Mackay. The Q&A portion of the call will also be joined by David Redfern.

    今天,我們的發言人是 Emma Walmsley、電話中的 Tony Wood、Luke Miels、Deborah Waterhouse 和 Iain Mackay。電話的問答部分也將由大衛雷德芬加入。

  • Turning to Slide 4. I'll now hand the call over to Emma.

    轉到幻燈片 4。我現在將電話交給 Emma。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Nick, and hello to everyone joining our Q3 conference call today. Please turn to the next slide.

    謝謝尼克,向今天參加我們第三季度電話會議的每個人問好。請翻到下一張幻燈片。

  • I'm very pleased with today's results, which demonstrate that our strategy is driving the step change in performance and landmark year we committed to. Year-to-date, we've delivered double-digit sales growth of 19%, adjusted operating profit growth of 16%, adjusted EPS growth of 20% and strong free cash flow of GBP 2.5 billion. This broad-based momentum and our continued pipeline progress support my strong confidence heading into 2023 and in our medium-term outlook and growth through the decade.

    我對今天的結果感到非常滿意,這表明我們的戰略正在推動業績的階梯式變化和我們承諾的具有里程碑意義的一年。年初至今,我們實現了 19% 的兩位數銷售額增長、16% 的調整後營業利潤增長、20% 的調整後每股收益增長和 25 億英鎊的強勁自由現金流。這種基礎廣泛的勢頭和我們持續的管道進展支持我對進入 2023 年以及我們在這十年中的中期前景和增長充滿信心。

  • Based on these encouraging results and our excellent momentum, we're again increasing our full year guidance, which excludes COVID solutions. We now expect sales to increase by between 8% to 10%, with improving outlook in all 3 product areas; adjusted operating profit growth between 15% to 17%; and adjusted EPS growth around 1% below adjusted operating profit.

    基於這些令人鼓舞的結果和我們良好的勢頭,我們再次提高了全年指導,其中不包括 COVID 解決方案。我們現在預計銷售額將增長 8% 至 10%,所有 3 個產品領域的前景都將改善;調整後的營業利潤增長在 15% 至 17% 之間;調整後的每股收益增長低於調整後的營業利潤約 1%。

  • Please turn to Slide 6. In Q3, we delivered another quarter of growth, with sales increasing 9% to GBP 7.8 billion; adjusted operating profit growing 4% to GBP 2.6 billion, an increase of 2%, excluding COVID solutions; and adjusted EPS growth of 11% to 46.9p. This performance was driven by consistently strong commercial execution all across our business as we build our broad portfolio of scale medicines and vaccines, with Specialty Medicines growing 24% to GBP 2.7 billion and by 11% excluding Xevudy. Here, we continue to benefit from demand for our HIV medicines, particularly Dovato and Cabenuva as well as Nucala in respiratory and Benlysta in immunology.

    請轉到幻燈片 6。在第三季度,我們實現了又一個季度的增長,銷售額增長 9% 至 78 億英鎊;調整後的營業利潤增長 4% 至 26 億英鎊,增長 2%,不包括 COVID 解決方案;調整後每股收益增長 11% 至 46.9 便士。這一業績是由我們在整個業務中持續強勁的商業執行推動的,因為我們建立了廣泛的規模藥物和疫苗組合,特種藥物增長 24% 至 27 億英鎊,不包括 Xevudy 增長 11%。在這裡,我們繼續受益於對我們的 HIV 藥物的需求,特別是 Dovato 和 Cabenuva 以及呼吸系統中的 Nucala 和免疫學中的 Benlysta。

  • Vaccine sales grew by 5% to GBP 2.5 billion and by 9% excluding pandemic vaccines. This strong performance reflected another record quarter for Shingrix, with sales exceeding GBP 750 million.

    疫苗銷售額增長 5% 至 25 億英鎊,不包括大流行性疫苗的銷售額增長 9%。這一強勁表現反映了 Shingrix 又一個創紀錄的季度,銷售額超過 7.5 億英鎊。

  • And lastly, General Medicines sales grew 1% to GBP 2.6 billion, driven by the strong growth of Trelegy in respiratory.

    最後,由於 Trelegy 在呼吸系統領域的強勁增長,General Medicines 的銷售額增長了 1% 至 26 億英鎊。

  • And we continue to invest in commercial growth and our R&D pipeline. In SG&A, we continued our disciplined cost control while prioritizing effective investments behind launches, particularly Shingrix as we accelerated international expansion, and in HIV to drive the growth of our innovation (inaudible).

    我們繼續投資於商業增長和我們的研發管道。在 SG&A 方面,我們繼續嚴格控製成本,同時優先考慮推出後的有效投資,特別是隨著我們加速國際擴張的 Shingrix,以及在 HIV 方面以推動我們創新的增長(聽不清)。

  • In R&D, we continued to increase investments in Vaccines' clinical development, including an mRNA technology and the newly acquired Affinivax MAPS platform as well as in late-stage specialty meds, particularly the Phase III program for depemokimab in severe asthma. We also continued our investment behind several earlier-stage research projects.

    在研發方面,我們繼續增加對疫苗臨床開發的投資,包括 mRNA 技術和新收購的 Affinivax MAPS 平台以及晚期專科藥物,特別是用於嚴重哮喘的 depemokimab 的 III 期項目。我們還繼續對幾個早期研究項目進行投資。

  • Turning to Slide 7 and our pipeline headline. This quarter, we took significant steps to progress our pipeline and platform capabilities. And of course, we're now delighted to have Tony as Chief Scientific Officer, and you'll hear more from him in a moment.

    轉到幻燈片 7 和我們的管道標題。本季度,我們採取了重大措施來提升我們的管道和平台能力。當然,我們現在很高興托尼擔任首席科學官,稍後您會聽到他的更多消息。

  • It was great to present at ID Week the Phase III results of our RSV older adults vaccine, which demonstrated more than 90% efficacy against severe disease, and wonderful to have received U.S. Priority Review as well as regulatory submission acceptances in Europe and Japan all over the last couple of weeks.

    很高興在 ID Week 上展示我們的 RSV 老年人疫苗的 III 期結果,該疫苗對嚴重疾病的療效超過 90%,很高興獲得美國的優先審查以及歐洲和日本各地的監管提交接受最後幾週。

  • Overall, we believe our RSV vaccine has a potential best-in-class profile, and we're very excited about the potential benefits it can bring to older adults. And of course, it's a tremendous commercial opportunity for GSK.

    總體而言,我們相信我們的 RSV 疫苗具有潛在的同類最佳特徵,我們對它可以為老年人帶來的潛在好處感到非常興奮。當然,這對葛蘭素史克來說是一個巨大的商業機會。

  • During the quarter, we also received several important regulatory approvals in our Vaccines business. And as we close out this landmark year, we look forward to further news flow across the portfolio.

    在本季度,我們的疫苗業務還獲得了幾項重要的監管批准。隨著我們結束這一具有里程碑意義的一年,我們期待著整個投資組合的更多新聞流。

  • I do want to reiterate, there are no changes in our capital allocation priorities. As a company, we continue to focus on making significant improvements in R&D productivity and performing competitively in the field, with our pipeline remaining our top priority. We'll continue to focus investments across 4 therapeutic areas while adding complementary and strategic business development to bring additional optionality.

    我確實想重申,我們的資本配置優先事項沒有變化。作為一家公司,我們繼續專注於顯著提高研發生產力並在該領域具有競爭力,我們的管道仍然是我們的首要任務。我們將繼續專注於 4 個治療領域的投資,同時增加互補性和戰略性業務發展,以帶來額外的選擇權。

  • This quarter, we completed the important acquisition of Affinivax and gained access to a Phase II, next-generation 24-valent vaccine. We also signed an exclusive license agreement with Spero Therapeutics for tebipenem, a novel oral antibiotic in late-stage development for UTIs.

    本季度,我們完成了對 Affinivax 的重要收購,並獲得了 II 期下一代 24 價疫苗。我們還與 Spero Therapeutics 就 tebipenem 簽署了獨家許可協議,tebipenem 是一種處於 UTI 後期開發的新型口服抗生素。

  • Importantly, we are consistently driving pipeline momentum. This remains our priority and, alongside our strong commercial performance, makes us stronger and better positioned to achieve our ambitions than we were even a year ago.

    重要的是,我們一直在推動管道動力。與一年前相比,這仍然是我們的首要任務,並且與我們強勁的商業業績一起,使我們更強大,更有能力實現我們的雄心壯志。

  • And now, Tony, first to you on Slide 8.

    現在,托尼,第 8 張幻燈片給你。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Thank you, Emma. Next slide, please. Our shared purpose within GSK is to unite science, technology and talent to get ahead of disease together. I want to spend the next few minutes explaining how R&D will support this objective and how I expect the organization to evolve under my leadership.

    謝謝你,艾瑪。請下一張幻燈片。我們在葛蘭素史克的共同目標是團結科學、技術和人才,共同戰勝疾病。我想在接下來的幾分鐘裡解釋研發將如何支持這一目標,以及我希望組織如何在我的領導下發展。

  • First, it's essential to recognize that GSK has changed. We have developed a unique operating model based on the science of the immune system, human genetics and advanced technologies. With this, we delivered a much more competitive performance in new drug approvals. This is encouraging and something our organization can be proud of, but there's more to be done. I'm confident we can further strengthen our pipeline of innovative and practice-changing new vaccines and medicines to deliver long-term competitive growth.

    首先,必須認識到葛蘭素史克已經發生了變化。我們基於免疫系統科學、人類遺傳學和先進技術開發了獨特的運營模式。有了這個,我們在新藥批准方面提供了更具競爭力的表現。這是令人鼓舞的,我們的組織可以引以為豪,但還有更多工作要做。我相信我們可以進一步加強我們的創新和改變實踐的新疫苗和藥物的管道,以實現長期的競爭性增長。

  • To achieve this, we will rigorously prioritize R&D capital allocation in our 4 therapeutic areas. To achieve these objectives, I have 3 key priorities for R&D.

    為實現這一目標,我們將嚴格優先在我們的 4 個治療領域分配研發資金。為了實現這些目標,我有 3 個研發重點。

  • My first priority is to execute flawlessly on our pipeline, today consisting of 23 vaccines and 42 medicines. Flawless execution means prosecuting the development of our late-stage pipeline, bringing new vaccines and medicines to patients as quickly as possible, organically and through business development. It also means accelerating our development of our most promising preclinical and early-stage research projects. Our guiding question will be: Can this meaningfully improve patient outcomes and deliver a new standard of care?

    我的首要任務是在我們的管道上完美執行,今天由 23 種疫苗和 42 種藥物組成。完美的執行意味著起訴我們後期管道的開發,盡快、有機地和通過業務發展為患者帶來新的疫苗和藥物。這也意味著加快我們最有前途的臨床前和早期研究項目的開發。我們的指導性問題是:這能否有效地改善患者的治療效果並提供新的護理標準?

  • My second key priority is exploiting new and existing platform and data technology to identify and accelerate clinical development opportunities. We already have a broad set of platform technologies, including an unrivaled suite within Vaccines. We'll continue to add to this, augmenting our capabilities.

    我的第二個關鍵優先事項是利用新的和現有的平台和數據技術來識別和加速臨床開發機會。我們已經擁有一套廣泛的平台技術,包括疫苗中無與倫比的套件。我們將繼續增加這一點,增強我們的能力。

  • To illustrate this, we leveraged our world-leading protein adjuvant capabilities to deliver a best-in-class RSV vaccine candidate for older adults. Likewise, through complementary strategic development, we acquired Affinivax and the disruptive MAPS technology mentioned by Emma. This allows us to develop multivalent vaccines for complex bacterial infections.

    為了說明這一點,我們利用我們世界領先的蛋白質佐劑能力為老年人提供一流的 RSV 候選疫苗。同樣,通過互補的戰略發展,我們收購了 Affinivax 和 Emma 提到的顛覆性 MAPS 技術。這使我們能夠開發出針對複雜細菌感染的多價疫苗。

  • In data technology, we have access to the richest and largest data set, thanks to our data-focused collaborations, including our recent agreement with Tempus, which provides access to one of the world's largest sources of deidentified patient data to accelerate drug discovery.

    在數據技術方面,由於我們以數據為中心的合作,包括我們最近與 Tempus 的協議,我們可以訪問最豐富和最大的數據集,該協議提供了對世界上最大的去識別患者數據來源之一的訪問,以加速藥物發現。

  • My third priority relates to R&D culture. A key element of my job is to create an environment in which we are ambitious for patients and where our people are empowered to take smart risks and make the right decision at the right time.

    我的第三個優先事項與研發文化有關。我工作的一個關鍵要素是創造一個環境,在這個環境中,我們對患者抱有雄心壯志,讓我們的員工有權承擔明智的風險並在正確的時間做出正確的決定。

  • First, taking smart risks is not solely a scientific endeavor. Luke and I chair a portfolio review board with cross-functional teams, providing input into all key R&D decisions. My partnership with Luke and Deborah is key and has never been more important as we allocate capital towards those new vaccines and medicines that have the greatest potential to raise the bar for patients.

    首先,明智地冒險不僅僅是一項科學努力。盧克和我主持了一個由跨職能團隊組成的投資組合審查委員會,為所有關鍵的研發決策提供意見。我與 Luke 和 Deborah 的合作關係至關重要,而且從未像現在這樣重要,因為我們將資金分配給那些最有可能提高患者標準的新疫苗和藥物。

  • Please turn to Slide 10. We will continue focusing on developing innovative vaccines and specialty medicines. Infectious diseases and HIV now represent about 2/3 of our pipeline and are the primary focus for R&D. We have an opportunity to build on our leading position in vaccines and complement the extraordinary success with Shingrix with new vaccine candidates for RSV in older adults, meningitis and pneumococcal disease.

    請轉到幻燈片 10。我們將繼續專注於開發創新疫苗和特色藥物。傳染病和艾滋病毒現在約占我們產品線的 2/3,是研發的主要重點。我們有機會鞏固我們在疫苗方面的領先地位,並用新的候選疫苗來補充 Shingrix 在老年人、腦膜炎和肺炎球菌疾病中的 RSV 候選疫苗的非凡成功。

  • In HIV, we are true innovation pioneers. We've led the way with 2 drug regimens and long-acting injectable medicines. We'll strengthen our leading position with longer-acting and more convenient treatments to people living with HIV and alternative options in pre-exposure prophylaxis.

    在 HIV 領域,我們是真正的創新先驅。我們在 2 種藥物方案和長效注射藥物方面處於領先地位。我們將通過為艾滋病毒感染者提供更有效和更方便的治療以及暴露前預防的替代選擇來鞏固我們的領先地位。

  • At the intersection of infectious disease and immunology, we're developing bepirovirsen, a potentially transformative treatment for people living with chronic hepatitis B, which is responsible for around 900,000 deaths annually. Bepi also represents a foundational asset of a new oligonucleotide platform that will increase our scope to prosecute promising new research targets from our leading position in genetics. We will prioritize immunology, respiratory and oncology programs using human genetics, functional genomics and AI/ML to support smart risk-taking.

    在傳染病和免疫學的交叉點,我們正在開發 bepirvirsen,這是一種潛在的變革性治療慢性乙型肝炎患者,每年導致約 900,000 人死亡。 Bepi 還代表了新寡核苷酸平台的基礎資產,該平台將擴大我們的範圍,以從我們在遺傳學領域的領先地位起訴有前途的新研究目標。我們將利用人類遺傳學、功能基因組學和人工智能/機器學習優先考慮免疫學、呼吸系統和腫瘤學項目,以支持明智的冒險行為。

  • Within oncology, our primary focus is Jemperli and the CD226 axis. And outside of IO, we'll take a pragmatic approach within synthetic lethality and tumor cell targeting.

    在腫瘤學中,我們的主要關注點是 Jemperli 和 CD226 軸。在 IO 之外,我們將在合成殺傷力和腫瘤細胞靶向方面採取務實的方法。

  • In business development, we will remain agile and ambitious, looking for opportunities that address high unmet medical needs and complement our R&D strategy. We'll also target opportunities with genetic evidence that suggests a higher probability of success.

    在業務發展中,我們將保持敏捷和雄心勃勃,尋找機會解決高未滿足的醫療需求並補充我們的研發戰略。我們還將針對具有更高成功概率的遺傳證據的機會。

  • Let me now review some of the recent highlights within our pipeline. Please turn to Slide 11. This quarter's highlight was the exceptional Phase III data for our novel RSV vaccine in older adults presented at ID Week.

    現在讓我回顧一下我們管道中最近的一些亮點。請轉到幻燈片 11。本季度的亮點是我們在 ID 週上展示的用於老年人的新型 RSV 疫苗的特殊 III 期數據。

  • RSV is a common contagious respiratory virus responsible for around 420,000 hospitalizations and 29,000 deaths annually in developed countries. RSV disease is a significant burden on the elderly, with almost half of all U.S. cases observed in the over 65s.

    RSV 是一種常見的傳染性呼吸道病毒,在發達國家每年造成約 420,000 人住院和 29,000 人死亡。 RSV 疾病是老年人的沉重負擔,美國幾乎一半的病例發生在 65 歲以上。

  • Our data demonstrated unprecedented efficacy in older adults, with 94% protection against severe RSV disease. The vaccine showed consistent and sustained high efficacy against RSV A and B strains in people in the 70s and those with comorbidities. The latter group is significant, with over 90% of adult hospitalized with RS disease -- RSV disease having underlying medical conditions. These patients suffer the most and have the greatest impact on health care costs.

    我們的數據證明了對老年人的前所未有的療效,對嚴重 RSV 疾病有 94% 的保護。該疫苗在 70 年代和患有合併症的人群中對 RSV A 和 B 株顯示出一致且持續的高效能。後一組意義重大,超過 90% 的成人因 RS 病住院 - RSV 病具有潛在的醫療條件。這些患者受害最深,對醫療保健費用的影響也最大。

  • We've submitted these data as part of a comprehensive package, which includes data demonstrating that the RSV vaccine can be coadministered with an influenza vaccine safely and without diminishing the immune response against either vaccine, an important consideration to the target population.

    我們已將這些數據作為綜合包的一部分提交,其中包括證明 RSV 疫苗可以安全地與流感疫苗共同給藥且不會降低對任何一種疫苗的免疫反應的數據,這是目標人群的一個重要考慮因素。

  • To date, we've received regulatory acceptance of our submissions by the European Medicines Agency and in Japan. And yesterday, we received U.S. regulatory acceptance and Priority Review with a goal date of the 3rd of May 2023, putting us firmly on track for June ACIP.

    迄今為止,我們已收到歐洲藥品管理局和日本對我們提交的監管機構的接受。昨天,我們收到了美國監管機構的接受和優先審查,目標日期為 2023 年 5 月 3 日,這使我們堅定地走上了 6 月 ACIP 的軌道。

  • Now moving to significant pipeline events, which occurred in 3Q, please turn to Slide 12. Earlier this quarter, we presented 10-year data for Shingrix also at ID Week. This demonstrated a persistent immune response and illustrated that the duration of protection against shingles extends to 10 years after vaccination. These data underscore the advantages of our proprietary adjuvant technology and setting new gold standard that will be very difficult to beat.

    現在轉到第三季度發生的重大管道事件,請轉到幻燈片 12。本季度早些時候,我們也在 ID 週上展示了 Shingrix 的 10 年數據。這證明了持續的免疫反應,並說明對帶狀皰疹的保護持續時間延長至接種疫苗後 10 年。這些數據強調了我們專有的輔助技術的優勢,並設定了難以超越的新黃金標準。

  • In HIV, we presented data from the Phase IIa proof-of-concept bNAb study for N6LS, our broadly neutralizing antibody. These early data show that a single infusion demonstrates strong antiviral activity. The decline in viral load, duration of response and good tolerability observed at 2 doses suggest a potential best-in-class antibody treatment.

    在 HIV 方面,我們提供了 N6LS(我們的廣泛中和抗體)的 IIa 期概念驗證 bNAb 研究的數據。這些早期數據表明,單次輸注具有很強的抗病毒活性。在 2 個劑量下觀察到的病毒載量下降、反應持續時間和良好的耐受性表明潛在的同類最佳抗體治療。

  • Next week, at the American Association for the Study of Liver Diseases Conference, we will present the B-Clear end-of-study data for bepirovirsen, a potential new treatment for people living with hepatitis B. This is an important trial because it demonstrates for the first time that bepi alone or in combination with antiviral nucleotide or nucleoside can deliver a sustained reduction in both viral DNA and HBV surface antigen, which together are key measures of efficacy.

    下週,在美國肝病研究協會會議上,我們將展示貝匹羅韋森的 B-Clear 研究結束數據,這是一種用於乙型肝炎患者的潛在新療法。這是一項重要的試驗,因為它表明首次單獨使用 bepi 或與抗病毒核苷酸或核苷聯合使用可以持續減少病毒 DNA 和 HBV 表面抗原,這兩者都是衡量療效的關鍵指標。

  • B-Clear also identified a clear predictor of response that will guide future development. We are currently in discussion with the regulators about the design of Phase III studies, and I look forward to providing an update at our full year results in February.

    B-Clear 還確定了一個明確的反應預測指標,將指導未來的發展。我們目前正在與監管機構討論 III 期研究的設計,我期待在 2 月份提供我們全年結果的更新。

  • In oncology, we announced positive headline results for the PERLA Phase II trial, the largest head-to-head trial of PD-1 inhibitors in non-squamous, non-small cell lung cancer. PERLA evaluated Jemperli versus pembrolizumab in combination with chemotherapy but was not designed to demonstrate superiority. These data will be used to support future clinical development of novel combinations.

    在腫瘤學方面,我們宣布了 PERLA II 期試驗的積極標題結果,這是 PD-1 抑製劑在非鱗狀、非小細胞肺癌中最大的頭對頭試驗。 PERLA 評估了 Jemperli 與 pembrolizumab 聯合化療,但並非旨在證明其優越性。這些數據將用於支持新組合的未來臨床開發。

  • We also announced that both arms of the COSTAR lung trial would progress into Phase III. This 3-arm trial compares cobolimab, dostarlimab and chemotherapy in patients with advanced non-small cell lung cancer who have progressed on prior PD-L1 therapy and chemotherapy.

    我們還宣布,COSTAR 肺試驗的兩個分支都將進入 III 期。這項 3 臂試驗比較了 cobolimab、dostarlimab 和化療對既往 PD-L1 治療和化療有進展的晚期非小細胞肺癌患者的療效。

  • Last week, the U.S. FDA Cardiorenal and Renal Drugs Advisory Committee (sic) [U.S. FDA Cardiovascular and Renal Drugs Advisory Committee] reviewed our application for daprodustat. We are pleased the committee recognized the potential for daprodustat to help certain patients living with anemia of chronic kidney disease, given their limited treatment options. We look forward to working with the FDA as they complete their review of our new drug application. Our PDUFA action date has been set for the 1st of February 2023.

    上週,美國 FDA 心臟和腎臟藥物諮詢委員會(原文如此)[U.S. FDA心血管和腎臟藥物諮詢委員會]審查了我們對達普司他的申請。我們很高興委員會認識到 daprodustat 有可能幫助某些患有慢性腎病貧血的患者,因為他們的治療選擇有限。我們期待與 FDA 合作,因為他們完成了對我們新藥申請的審查。我們的 PDUFA 行動日期已定為 2023 年 2 月 1 日。

  • Finally, we decided we will progress otilimab. Although the pivotal ContRAst trial's met their primary endpoints, the efficacy demonstrated is unlikely to transform care for this difficult-to-treat population.

    最後,我們決定繼續推進 otilimab。儘管關鍵的 ContRAst 試驗達到了主要終點,但所證明的療效不太可能改變對這一難以治療人群的護理。

  • Please turn to Slide 13. Looking ahead, we anticipate several significant late-stage readouts and regulatory decisions over the next 12 months. I won't attempt to go through everything on this slide, but I want to highlight few key events.

    請轉到幻燈片 13。展望未來,我們預計未來 12 個月將有幾個重要的後期讀數和監管決策。我不會試圖介紹這張幻燈片上的所有內容,但我想強調幾個關鍵事件。

  • In particular, before year-end, we expect to report data from our pentavalent meningococcal vaccine, MenABCWY, as well as data from the RUBY trial in first-line endometrial cancer for Jemperli. For Blenrep, we're on track to provide an update for DREAMM-3 before the end of the year. And we anticipate data from DREAMM-7 and DREAMM-8 in the second-line setting in 2023. We also expect FDA regulatory decisions for daprodustat and momelotinib in the first half of 2023.

    特別是,我們希望在年底前報告我們的五價腦膜炎球菌疫苗 MenABCWY 的數據,以及 Jemperli 一線子宮內膜癌 RUBY 試驗的數據。對於 Blenrep,我們有望在年底前為 DREAMM-3 提供更新。我們預計 DREAMM-7 和 DREAMM-8 的數據將在 2023 年用於二線治療。我們還預計 FDA 將在 2023 年上半年對 daprodustat 和 momelotinib 做出監管決定。

  • With that, I'll now turn the call over to Luke. Please turn to Slide 14.

    有了這個,我現在把電話轉給盧克。請轉到幻燈片 14。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Thanks, Tony. Please turn to Slide 15. So in Q3, we saw strong execution across commercial operations, with total sales growth of 9% in the quarter and increasing demand from all product groups. 2 percentage points of growth came from Xevudy, so the ex pandemic overall sales growth of 7%. Based on this good performance and our ongoing momentum, we've increased our full year sales guidance Specialty Medicines to low double digits, excluding Xevudy.

    謝謝,托尼。請轉到幻燈片 15。因此,在第三季度,我們看到整個商業運營的執行力強勁,該季度的總銷售額增長了 9%,並且所有產品組的需求都在增加。 2個百分點的增長來自Xevudy,因此疫情前整體銷售增長7%。基於這種良好的表現和我們持續的勢頭,我們將全年銷售指導特種藥物提高到兩位數,不包括 Xevudy。

  • As usual, Deborah will comment on HIV, while I highlight a few key dynamics. In immunology, Benlysta continues to be the leader in lupus, with sustained growth across major markets, including the U.S., where we're getting 80% of new starts. We're also making good progress with the lupus nephritis indication, now reaching around 15% of patients in the U.S. with plenty of room to grow.

    像往常一樣,黛博拉將評論艾滋病毒,而我強調一些關鍵的動態。在免疫學方面, Benlysta 繼續成為狼瘡領域的領導者,在包括美國在內的主要市場持續增長,我們在美國獲得了 80% 的新起點。我們在狼瘡性腎炎適應症方面也取得了良好進展,現在美國約有 15% 的患者有足夠的發展空間。

  • For Nucala, we continue to be the first and only biologic approved for 4 eos-driven diseases and are leading the IL-5 class across all major markets. In the U.S., we have now had more than 50% market share for all our approved indications, and we're on track to potentially add a fifth, with our Phase III COPD trial due to complete in the first half of 2024.

    對於 Nucala,我們繼續成為第一個也是唯一一個獲批用於 4 種 eos 驅動疾病的生物製劑,並在所有主要市場中領先於 IL-5 類別。在美國,我們所有批准的適應症的市場份額現已超過 50%,我們有望增加五分之一,我們的 III 期 COPD 試驗將於 2024 年上半年完成。

  • In oncology, our in-line and launched brands delivered double-digit growth, achieving GBP 164 million in the quarter, including Zejula, which was up 11%, and Blenrep up 32%.

    在腫瘤領域,我們的在線和新推出的品牌實現了兩位數的增長,本季度實現了 1.64 億英鎊,其中 Zejula 增長了 11%,Blenrep 增長了 32%。

  • In General Medicines, we continue to lead the single inhaler therapy class with Trelegy and saw an increase in demand for Augmentin due to the postpandemic rebound of the antibiotic market. As a result of this performance in the quarter and year-to-date, we now expect full year sales for gen meds to be broadly flat, which compares to the slight decrease that was previously signaled.

    在普通藥物方面,我們繼續與 Trelegy 一起引領單一吸入器治療類別,並且由於抗生素市場的大流行後反彈,對 Augmentin 的需求增加。由於本季度和年初至今的這一表現,我們現在預計 gen meds 的全年銷售額將大致持平,而之前的信號則略有下降。

  • Turning to our Vaccines' performance on Slide 16. Our Vaccines' performance was very strong, with sales growth of 9%, excluding the impact of prior year pandemic vaccine sales. This growth was driven by the continued recovery of Shingrix, where we delivered another record quarter of turnover. In the U.S., Shingrix sales benefited from higher demand in both retail and nonretail channels, which was partly offset by expected unfavorable wholesale inventory movements. Outside the U.S., we are seeing the growing impact of new launches and strong commercial execution in Europe and international, with nearly 40% of Shingrix's Q3 sales now coming from markets outside of the U.S.

    談到我們在幻燈片 16 上的疫苗表現。我們的疫苗表現非常強勁,銷售額增長了 9%,不包括上一年大流行疫苗銷售的影響。這一增長是由 Shingrix 的持續復甦推動的,我們在該季度實現了另一個創紀錄的營業額。在美國,Shingrix 的銷售受益於零售和非零售渠道的需求增加,這部分被預期的不利批發庫存變動所抵消。在美國以外,我們看到歐洲和國際新產品發布和強大的商業執行的影響越來越大,Shingrix 第三季度近 40% 的銷售額現在來自美國以外的市場。

  • Shingrix is now available in 25 countries with 2 new launches during Q3, and we remain on track to expand our geographic footprint. In 2024, we plan to be in 35 countries, representing nearly 90% of the global vaccines market. And we continue to expect Shingrix to deliver record year performance with strong double-digit sales growth this year.

    Shingrix 現已在 25 個國家/地區推出,第三季度推出了 2 款新產品,我們仍在繼續擴大我們的地理足跡。到 2024 年,我們計劃在 35 個國家/地區開展業務,佔全球疫苗市場的近 90%。我們繼續預計 Shingrix 將在今年以兩位數的強勁銷售增長實現創紀錄的年度業績。

  • We now expect fourth quarter growth to be lower than in previous quarter due to expected inventory burn in the U.S., reflecting the drawdown in inventory channel build from earlier this year. For Vaccines overall, excluding pandemic solutions, we expect sales growth for the full year in the mid- to high teens, up from our low to mid-teens expectation in Q2. This reflects strong commercial execution across the portfolio and increased contributions from Bexsero in the U.S. due to higher CDC purchases and increased market share versus Pfizer.

    我們現在預計第四季度的增長將低於上一季度,原因是美國預期的庫存消耗,反映了今年早些時候庫存渠道建設的減少。對於整體疫苗,不包括大流行解決方案,我們預計全年銷售增長將在中高位,高於我們在第二季度的低至中位預期。這反映了整個投資組合的強大商業執行力,以及由於 CDC 購買量增加以及與輝瑞相比市場份額增加,Bexsero 在美國的貢獻增加。

  • Let me now hand over to Deborah on Slide 17.

    現在讓我在幻燈片 17 上交給黛博拉。

  • Deborah Jayne Waterhouse - CEO of ViiV Healthcare

    Deborah Jayne Waterhouse - CEO of ViiV Healthcare

  • Thanks, Luke. We delivered another good quarter with HIV sales of GBP 1.5 billion, up 7%, taking year-to-date growth to 9%. Performance benefited from strong patient demand for our innovation portfolio, which comprises Dovato, Cabenuva, Juluca, Rukobia and Apretude, and now accounts for 44% of our sales.

    謝謝,盧克。我們又迎來了一個不錯的季度,HIV 銷售額達到 15 億英鎊,增長 7%,使年初至今的增長率達到 9%。業績得益於患者對我們創新產品組合的強勁需求,其中包括 Dovato、Cabenuva、Juluca、Rukobia 和 Apretude,目前占我們銷售額的 44%。

  • Strong growth of 11% in each of the U.S. and Europe was the result of excellent commercial execution behind our 2 drug regimens and Dovato in particular. For the first time in a quarter, Dovato sales exceeded those of Tivicay, with Dovato accounting for almost 25% of our total HIV business.

    在美國和歐洲分別實現了 11% 的強勁增長,這是我們的 2 種藥物方案(尤其是 Dovato)背後出色的商業執行的結果。一個季度以來,Dovato 的銷售額首次超過了 Tivicay,Dovato 占我們 HIV 總業務的近 25%。

  • Turning to our injectable portfolio. Cabenuva, also known as Vocabria/Rekambys in Europe, is our first-in-class long-acting treatment regimen for HIV. Sales for the quarter were GBP 101 million, reflecting strong patient demand.

    轉向我們的注射產品組合。 Cabenuva,在歐洲也被稱為 Vocabria/Rekambys,是我們一流的 HIV 長效治療方案。本季度銷售額為 1.01 億英鎊,反映了強勁的患者需求。

  • At AIDS 2022, we were pleased to present new data from the CARISEL study, demonstrating successful implementation of the Vocabria/Rekambys across a range of European health care settings. More than 80% of study (inaudible) supported that the complete long-acting regimen was less stigmatizing than daily oral treatment. The outlook for this innovative medicine is compelling, with strong brand recognition and high levels of market access and reimbursement across the U.S. and Europe.

    在 2022 年 AIDS 大會上,我們很高興展示 CARISEL 研究的新數據,展示了 Vocabria/Rekambys 在一系列歐洲醫療保健機構中的成功實施。超過 80% 的研究(聽不清)支持完整的長效治療方案比每日口服治療的恥辱感更小。這種創新藥物的前景令人信服,在美國和歐洲擁有強大的品牌知名度和高水平的市場准入和報銷。

  • Moving on to prevention. Apretude is the world's first long-acting injectable for the prevention of HIV dosed every 2 months. Launched in the U.S. in January, Apretude delivered GBP 10 million of sales in the quarter.

    繼續預防。 Apretude 是世界上第一個用於預防 HIV 的長效注射劑,每 2 個月給藥一次。 Apretude 於 1 月份在美國推出,該季度實現了 1000 萬英鎊的銷售額。

  • HIV prevention is an area of huge unmet need as current medical options are associated with stigma and adherence issues. Apretude addresses these issues and has demonstrated superior efficacy over daily oral tablets.

    HIV 預防是一個巨大的未滿足需求領域,因為當前的醫療選擇與污名和依從性問題有關。 Apretude 解決了這些問題,並證明了優於每日口服片劑的功效。

  • In the last week, [we announced that European Medicines Agency] has accepted our application to make Apretude available for people who would benefit from PrEP in Europe. This is an important step forward in offering expanded options for HIV prevention.

    上週,[我們宣佈歐洲藥品管理局] 已接受我們的申請,為將在歐洲受益於 PrEP 的人們提供 Apretude。這是在為艾滋病毒預防提供更多選擇方面向前邁出的重要一步。

  • And finally, we were pleased to present more than 50 abstracts across the recent scientific congresses ID Week and HIV Glasgow. The highlight, as Tony mentioned earlier, was the positive proof-of-concept data from the bNAb study of N6LS, our investigational, broadly neutralizing antibody.

    最後,我們很高興在最近的科學大會 ID Week 和 HIV Glasgow 上展示了 50 多篇摘要。正如托尼之前提到的,重點是來自我們的研究性廣泛中和抗體 N6LS 的 bNAb 研究的陽性概念驗證數據。

  • In conclusion, our Q3 results demonstrate continued positive momentum towards delivering our 2026 outlook and successfully evolving our product mix to the end of the decade.

    總而言之,我們的第三季度業績表明,我們在實現 2026 年展望和成功地將我們的產品組合發展到本世紀末的過程中保持了積極的勢頭。

  • I will now hand over to Iain. Next slide, please.

    我現在將交給伊恩。請下一張幻燈片。

  • Iain James Mackay - CFO & Executive Director

    Iain James Mackay - CFO & Executive Director

  • Thanks, Deborah. As I cover the financials, references to growth are at constant exchange rates unless stated otherwise. As Luke has covered the main revenue drivers, I'll focus my comments on the income statement, including margins, cash flow, capital allocation and guidance.

    謝謝,黛博拉。在我介紹財務數據時,除非另有說明,否則對增長的引用均以恆定匯率計算。由於盧克已經涵蓋了主要的收入驅動因素,我將把我的評論集中在損益表上,包括利潤率、現金流、資本分配和指導。

  • Please turn to Slide 19. Whilst my comments will focus on continuing operations, I will start by covering the effect of the demerger in total results. Total earnings per share were 255.9p, of which earnings per share from discontinued operations were 237.1p in the quarter. This reflected GBP 9.6 billion profit after taxation for the gain arising in the demerger of Consumer Healthcare. This was comprised of a GBP 7.2 billion gain on demerger and a GBP 2.4 billion gain on the retained stake in Haleon.

    請轉到幻燈片 19。雖然我的評論將集中在持續運營上,但我將首先介紹分拆對總體結果的影響。每股總收益為 255.9 便士,其中本季度已終止業務的每股收益為 237.1 便士。這反映了消費者醫療保健分拆產生的 96 億英鎊稅後利潤。這包括分拆帶來的 72 億英鎊收益和 Haleon 保留股權的 24 億英鎊收益。

  • Turning now to continuing operations. For the third quarter of 2022, Commercial Operations turnover was GBP 7.8 billion, up 9%, and adjusted operating profit was GBP 2.6 billion, up 4%. Total earnings per share were 18.8p, down 35%, while adjusted earnings per share were 46.9p, up 11%.

    現在轉向持續運營。 2022 年第三季度,商業運營營業額為 78 億英鎊,增長 9%,調整後的營業利潤為 26 億英鎊,增長 4%。每股總收益為 18.8 便士,下降 35%,而調整後的每股收益為 46.9 便士,增長 11%。

  • The main adjusting items of note between total and adjusted results for continuing operations in Q3 were in transaction related, which primarily reflected ViiV contingent consideration liability movements, the majority of which related to foreign exchange, and in divestments, significant, legal and other, which reflected a fair value movement -- sorry, fair value mark-to-market loss on retained stake in Haleon.

    三季度持續經營業績總額與調整後業績之間的主要調整項目為交易相關,主要反映 ViiV 或有對價負債變動,其中大部分與外匯有關,以及資產剝離、重大、法律等反映了公允價值變動——抱歉,Haleon 保留股權的公允價值按市值計價損失。

  • Pandemic solutions increased growth of adjusted operating profit by approximately 2 percentage points and growth of adjusted earnings per share by around 3 points. The Q3 currency impact was a favorable 9% on sales and 14% in adjusted earnings per share.

    大流行解決方案使調整後的營業利潤增長約 2 個百分點,調整後的每股收益增長約 3 個百分點。第三季度的貨幣影響是對銷售額有利的 9%,對調整後的每股收益有利 14%。

  • Turning to next slide. The Q3 margin of 33.3% was stable and aligned with 2021's delivery. The positive margin dynamics reflected the sales growth with a favorable mix, excluding Xevudy, higher royalty income and favorable currency movements, which were a 1.6-percentage-point benefit in the third quarter. These factors were offset by the impact of lower margin sales of Xevudy and continued commercial investment behind launches and key products.

    轉到下一張幻燈片。第三季度 33.3% 的利潤率穩定,與 2021 年的交付情況一致。積極的利潤率動態反映了銷售增長與有利的組合,不包括 Xevudy、更高的特許權使用費收入和有利的匯率變動,這是第三季度 1.6 個百分點的收益。這些因素被 Xevudy 較低的利潤率銷售以及推出和關鍵產品背後的持續商業投資的影響所抵消。

  • COVID solutions increased adjusted profit growth by approximately 2 percentage points. And the adjusted operating margin, excluding COVID solutions, was approximately 1.3 percentage points lower at constant exchange rates.

    COVID 解決方案將調整後的利潤增長提高了約 2 個百分點。在固定匯率下,調整後的營業利潤率(不包括 COVID 解決方案)降低了約 1.3 個百分點。

  • Within cost of goods sold, the increase primarily related to sales of lower margins of Xevudy, which increased the cost of sales margin by around 2 percentage points, mainly reflecting the profit share pay away to Vir Biotechnology.

    在銷售成本中,增加主要與 Xevudy 利潤率較低的銷售有關,這使銷售利潤率成本增加約 2 個百分點,主要反映了向 Vir Biotechnology 支付的利潤份額。

  • Excluding Xevudy, cost of goods sold benefited from a favorable business mix, with Specialty Medicines and Vaccines comprising 65% of Commercial Operations sales ex pandemic. So this mix benefit was offset by increased supply chain costs, including commodity prices and freight, which we continue to manage closely.

    除 Xevudy 外,銷售商品成本受益於有利的業務組合,特殊藥物和疫苗佔大流行前商業運營銷售額的 65%。因此,這種混合收益被供應鏈成本增加所抵消,包括商品價格和運費,我們將繼續密切管理。

  • SG&A increased at a higher rate than sales in the quarter, which reflected launch investments in Specialty Medicines and Vaccines. This was particularly focused on HIV and Shingrix to drive postpandemic demand recovery and support market expansion. Trade and distribution costs also contributed to the increase. These factors were partly offset by continued delivery of restructuring benefits and the gains on the Vir Biotechnology collaboration profit share.

    SG&A 的增長率高於本季度的銷售額,這反映了對特種藥物和疫苗的啟動投資。這特別關注 HIV 和 Shingrix,以推動大流行後需求復蘇並支持市場擴張。貿易和分銷成本也促成了這一增長。這些因素被持續提供的重組收益和 Vir Biotechnology 合作利潤份額的收益部分抵消。

  • R&D spend grew 8% in the quarter, with increased investment across several programs, particularly in Vaccines' clinical development, including our mRNA technology platforms and MAPS following the Affinivax acquisition; in Specialty Medicines, with assets like depemokimab and momelotinib; and in early-stage research programs. These increases were partly offset by the lapping of now completed late-stage clinical programs and ongoing efficiencies.

    本季度研發支出增長 8%,多個項目的投資增加,特別是在疫苗的臨床開發方面,包括收購 Affinivax 後我們的 mRNA 技術平台和 MAPS;在特種藥物領域,擁有 depemokimab 和 momelotinib 等資產;並在早期研究計劃中。這些增長部分被現已完成的後期臨床項目的完成和持續的效率所抵消。

  • Royalties benefited from Biktarvy contribution and higher sales of Gardasil.

    版稅受益於 Biktarvy 的貢獻和 Gardasil 的更高銷售額。

  • In the year-to-date, adjusted operating profit grew 16% to GBP 6.6 billion, with an operating margin of 29.9%, reflecting the strong business performance. In the commercial (inaudible) and (inaudible) solutions, [the adjusted] operating profit was neutral.

    年初至今,調整後的營業利潤增長 16% 至 66 億英鎊,營業利潤率為 29.9%,反映了強勁的業務表現。在商業(聽不清)和(聽不清)解決方案中,[調整後的]營業利潤是中性的。

  • Turning to Slide 21. Moving to (inaudible) this time now, I would highlight that net finance expense was slightly lower, reflecting increased interest income due to higher interest rates and larger cash balances following the demerger. And the effective tax rate of 16.6% reflected the timing of settlements with various tax authorities.

    轉到幻燈片 21。現在轉到(聽不清),我要強調淨財務費用略低,這反映了由於分拆後更高的利率和更大的現金餘額導致的利息收入增加。 16.6%的有效稅率反映了與各稅務機關結算的時間。

  • On the next slide, I'll cover cash flow. In the year-to-date, we generated GBP 2.5 billion of free cash flow from continuing operations. The main driver of higher free cash flow this year has been higher cash generated from operations, which has grown 49% to GBP 5.8 billion. And this has primarily benefited from increased operating profit, including the upfront income from the Gilead settlement in February, a favorable foreign exchange impact and favorable timing of collections. And these factors were partly offset by unfavorable timing of profit share payments for sales of Xevudy, increased contingent consideration payments reflecting the Gilead settlement and increased cash contributions to pensions in the third quarter.

    在下一張幻燈片中,我將介紹現金流。年初至今,我們從持續經營中產生了 25 億英鎊的自由現金流。今年自由現金流增加的主要驅動力是運營產生的現金增加,增長了 49%,達到 58 億英鎊。這主要得益於營業利潤的增加,包括 2 月份吉利德和解的前期收入、有利的外匯影響和有利的收款時機。這些因素部分被 Xevudy 銷售利潤分成支付的不利時機、反映吉利德和解的或有對價支付增加以及第三季度對養老金的現金貢獻增加所抵消。

  • Below cash generated from operations, there were higher tax payments and reduced purchase of intangibles, partly offset by lower proceeds from disposals and increased capital investments. We continue to have a keen focus on cash generation, and we're pleased with our progress this year.

    在經營產生的現金之下,有更高的稅收和減少的無形資產購買,部分被處置收益的減少和資本投資的增加所抵消。我們繼續密切關注現金產生,我們對今年的進展感到高興。

  • I'll take the opportunity to reiterate our capital allocation framework, which supports continuing investment in the business for future growth through R&D, both organic and inorganic, as evidenced by Sierra Oncology and Affinivax deals, through commercial excellence, new product launches and effective capital projects as well as delivering growing and sustainable shareholder returns, including through our dividend policy.

    我將藉此機會重申我們的資本分配框架,該框架通過卓越的商業、新產品發布和有效資本,通過有機和無機研發支持對業務的持續投資,以實現未來增長,正如 Sierra Oncology 和 Affinivax 交易所證明的那樣項目以及提供不斷增長和可持續的股東回報,包括通過我們的股息政策。

  • Our strength in balance sheet provides a basis from which we can execute this policy, with net debt standing at around GBP 18 billion after the recent acquisitions. This provides greater flexibility and supports our maintenance of a strong investment-grade rating.

    我們在資產負債表方面的實力為我們執行這項政策提供了基礎,在最近的收購之後,淨債務約為 180 億英鎊。這提供了更大的靈活性,並支持我們維持強大的投資級評級。

  • Turning now to Slide 23. Moving on to guidance. Q3 performance was again slightly better than our expectations, and our year-to-date delivery has been strong. Taking that momentum and the positive fundamentals into account, we're again raising our guidance for full year 2022.

    現在轉到幻燈片 23。繼續進行指導。第三季度的表現再次略好於我們的預期,而且我們年初至今的交付量一直很強勁。考慮到這一勢頭和積極的基本面,我們再次提高了對 2022 年全年的指導。

  • We now expect sales, excluding COVID solutions, to increase between 8% and 10% at constant exchange rates, and for adjusted operating profit to increase between 15% and 17%. We expect the year-on-year impact from COVID solutions to reduce adjusted operating profit growth by around 4% for the full year.

    我們現在預計,不包括 COVID 解決方案的銷售額將按固定匯率增長 8% 至 10%,調整後的營業利潤將增長 15% 至 17%。我們預計 COVID 解決方案的同比影響將使全年調整後的營業利潤增長減少約 4%。

  • In the fourth quarter, we anticipate a relatively higher rate of R&D spend, reflecting prior year comparisons and in-year phasing as well as continued targeted investment.

    在第四季度,我們預計研發支出率會相對較高,這反映了上一年的比較和年內分階段以及持續的目標投資。

  • In the run for the full year, we also expect adjusted earnings per share to be 1% lower than adjusted operating profit growth, reflecting the balance of adjustments to the expected effective tax and interest expense charges.

    在全年的運行中,我們還預計調整後的每股收益將比調整後的營業利潤增長低 1%,這反映了對預期有效稅費和利息費用的調整餘額。

  • For the third quarter, we've declared a dividend of 13.75p per share, in line with expectations.

    第三季度,我們宣布派發每股 13.75 便士的股息,符合預期。

  • Before closing, let me touch on Zantac given the impact it has had in the stock price over recent months. We set out the facts in the press releases on the 11th and 16th of August, and today's results release provides the latest information on the U.S. cases.

    在結束之前,讓我談談 Zantac 考慮到它最近幾個月對股價的影響。我們在 8 月 11 日和 16 日的新聞稿中列出了事實,今天的結果發布提供了有關美國案件的最新信息。

  • GSK's position on the scientific validity of these cases has not changed, and we'll continue to defend all claims vigorously. As you will have seen, we await the outcome of Daubert hearings over the coming weeks, and we will, of course, continue to update the market as things evolve.

    GSK 對這些案例的科學有效性的立場沒有改變,我們將繼續大力捍衛所有主張。正如您將看到的,我們等待未來幾週 Daubert 聽證會的結果,當然,隨著事情的發展,我們將繼續更新市場。

  • We continue to be highly confident in the performance of the business and are optimistic that the step change in delivery that we've seen in 2022 to date will continue in Q4 and will set up GSK for another year of success in 2023.

    我們繼續對業務表現充滿信心,並樂觀地認為,我們在 2022 年迄今為止看到的交付方面的階梯式變化將在第四季度繼續下去,並將讓 GSK 在 2023 年再次取得成功。

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

    有了這個,我會把它還給艾瑪。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Iain. And turning lastly to Slide 25. We continue to be guided by our purpose to unite science, technology and talent to get ahead of disease together. Integral to this is running a responsible business, which builds trust and reduces (inaudible) health impact, shareholder returns and supporting our people to thrive.

    謝謝,伊恩。最後轉到幻燈片 25。我們將繼續以團結科學、技術和人才的目標為指導,共同戰勝疾病。與此息息相關的是經營一家負責任的企業,它可以建立信任並減少(聽不清)對健康的影響、股東回報並支持我們的員工茁壯成長。

  • This quarter, we advanced our environmental leadership by launching our Sustainable Procurement Programme at Climate Week in New York. The recently announced S&P Corporate Sustainability Assessment also recognized our sustainability leadership. And we were also delighted to gain World Health Organization prequalification for our malaria vaccine, a key step in making this groundbreaking vaccine available to more children.

    本季度,我們在紐約氣候周啟動了可持續採購計劃,從而提升了我們在環境方面的領導地位。最近公佈的標準普爾企業可持續發展評估也認可了我們在可持續發展方面的領導地位。我們也很高興我們的瘧疾疫苗獲得了世界衛生組織的資格預審,這是向更多兒童提供這種開創性疫苗的關鍵一步。

  • In closing, I want to thank our people for delivering this tremendous performance momentum. I'm deeply committed to GSK being a company that helps our talented people thrive, and we recognize the significant pressures many are experiencing due to the unprecedented context and the practicalities of the rising cost of living in many parts of the world. And this quarter, we invested in supporting those most affected as well as in company-wide enhanced benefits and well-being support.

    最後,我要感謝我們的員工提供瞭如此巨大的業績勢頭。我堅定地致力於讓 GSK 成為一家幫助我們的人才茁壯成長的公司,我們認識到由於前所未有的環境和世界許多地方生活成本不斷上漲的現實,許多人正在承受巨大的壓力。本季度,我們投資於支持受影響最嚴重的人以及全公司範圍內增強的福利和福祉支持。

  • Together, we are delivering our landmark year, also with another quarter of strong performance, upgraded guidance and excellent momentum as we look to the years ahead as a focused global biopharma company. We are well on track to meet our bold ambitions for patients and our commitments to competitive growth for the decade ahead.

    隨著我們作為一家專注的全球生物製藥公司展望未來幾年,我們共同實現了具有里程碑意義的一年,又一個季度的強勁業績、升級的指導和良好的勢頭。我們正在順利實現我們對患者的雄心壯志以及我們對未來十年競爭性增長的承諾。

  • With that, operator, can we please move to the Q&A?

    有了這個,接線員,我們可以轉到問答環節嗎?

  • Operator

    Operator

  • (Operator Instructions) And with that, our first question comes from James Gordon from JPM.

    (操作員說明)我們的第一個問題來自 JPM 的 James Gordon。

  • James Daniel Gordon - Senior Analyst

    James Daniel Gordon - Senior Analyst

  • James Gordon from JPMorgan. First question was on older adult RSV vaccine. So we now have the GSK and the Pfizer data in the public domain. What can we say on the comparative efficacy and tolerability? Are you still seeing GSK taking the dominant market share? Or could these end up being similar products with the same ACIP recommendation because maybe you've got better efficacy but not so good on tolerability? And what could a product like this -- what might the ramp look like? Is Shingrix a proxy?

    摩根大通的詹姆斯·戈登。第一個問題是關於老年人 RSV 疫苗的。所以我們現在在公共領域擁有 GSK 和輝瑞的數據。關於比較療效和耐受性,我們能說些什麼?您是否仍然看到葛蘭素史克佔據主導市場份額?或者這些最終是否會成為具有相同 ACIP 推薦的類似產品,因為也許您的療效更好但耐受性不太好?像這樣的產品會是什麼——坡道會是什麼樣子? Shingrix 是代理嗎?

  • And if I could also just squeeze in a follow-up question, which is a more general one on the pipeline. So a question for Tony, which would be, how are you thinking about peak sales potential for the pipeline? It seems like oncology is a bit less of a focus than before. And there were some quite plenty targets set before. So Blenrep Zejula, Jemperli, they're multibillion dollar products (inaudible) forecast? Or might those be under review? And are there other areas maybe outside oncology where you see higher peak sales potential?

    如果我也可以插入一個後續問題,這是一個更普遍的問題。那麼托尼的一個問題是,您如何看待管道的峰值銷售潛力?腫瘤學似乎不像以前那樣受到關注。並且之前設定了一些相當多的目標。那麼 Blenrep Zejula 和 Jemperli,它們是數十億美元的產品(聽不清)的預測?或者可能正在審查中?是否還有其他領域可能在您看到更高的峰值銷售潛力的腫瘤學之外?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, James. Well, 2 quite chunky questions there. I'll come to Tony first, and let's deal with the RSV question. But then I think, Tony, you can talk about the data, both on efficacy and tolerability, and Luke, perhaps you can pick up on the ramp. And then we'll come back on your question on overall pipeline strength and prospects.

    謝謝,詹姆斯。好吧,那裡有2個相當粗略的問題。我先來找托尼,讓我們來處理 RSV 問題。但後來我想,托尼,你可以談談關於功效和耐受性的數據,盧克,也許你可以在坡道上學習。然後我們會回到你關於整體管道實力和前景的問題。

  • I just want to reiterate, James, what I said in my comments, which is compared to where we were just a year ago when we presented both our outlooks for growth and the 5-year horizon and a snapshot in that moment of time of the risk-adjusted pipeline, we are in a better and stronger position when we look across those 3 periods on a net basis. Obviously, some things go away. Other things have matured. And as you know, we've added business development and maturing early pipeline in a fairly material way as well. So we would always expect that to keep adjusting.

    詹姆斯,我只想重申我在評論中所說的話,這與一年前我們提出增長前景和 5 年展望以及當時那一刻的快照相比。風險調整後的管道,當我們從淨額來看這三個時期時,我們處於更好和更強大的位置。顯然,有些事情會消失。其他的東西已經成熟了。如您所知,我們還以相當重要的方式增加了業務開發和成熟的早期管道。所以我們總是希望它會繼續調整。

  • But first of all, let's deal with RSV in the round, and then we'll come back. Tony, if you want to comment on -- building on your presentation on some of the pipeline assets. But RSV first, please.

    但首先,讓我們全面處理 RSV,然後再回來。托尼,如果您想發表評論,請在您對一些管道資產的演示文稿的基礎上進行評論。但請先 RSV。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. Thank you, Emma. And James, thank you for the question. The first thing I would stress is that we're confident that our vaccine has a best-in-class profile. And that really is anchored on the consistent high vaccine efficacy, particularly against RSV lower respiratory tract disease in the 70 to 79 population and in those with comorbidities. And we know from the CDC that 94% of adults hospitalized with RSV disease are in those comorbid populations. And just to remind you, there, we have consistent 94% vaccine efficacy across the board.

    是的。謝謝你,艾瑪。詹姆斯,謝謝你的提問。我要強調的第一件事是,我們有信心我們的疫苗具有一流的特性。這確實是基於持續的高疫苗效力,特別是針對 70 至 79 歲人群和合併症患者的 RSV 下呼吸道疾病。我們從 CDC 獲悉,94% 因 RSV 疾病住院的成年人屬於這些合併症人群。只是提醒您,在那裡,我們全面保持 94% 的疫苗效力。

  • I'd also highlight the data that we have with flu coadmin, which serves to show no impact on efficacy of either vaccine, again, important in that population. And the fact that we have a high vaccine efficacy against both A and B strains, with an overall vaccine efficacy of 82.6%. So we're confident in our best-in-class efficacy profile.

    我還要強調我們與流感聯合管理的數據,這表明對這兩種疫苗的功效沒有影響,這在該人群中也很重要。事實上,我們對 A 株和 B 株都具有很高的疫苗效力,總體疫苗效力為 82.6%。因此,我們對我們一流的功效概況充滿信心。

  • As far as tolerability is concerned, then the data we have shows that reactogenicity is mild to moderate. It resolves within 2 days. And it's entirely consistent with the level of reactogenicity that is seen for a majority of adult vaccines.

    就耐受性而言,我們擁有的數據表明反應原性是輕度到中度的。它會在 2 天內解決。這與大多數成人疫苗的反應原性水平完全一致。

  • Emma, I'll leave it there in terms of the RSV answer.

    艾瑪,我會根據 RSV 的答案把它留在那裡。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Sure. And I think just to build on Tony's point, I mean I would expect at this point that ACIP would take a relatively conservative position, but we have until June of next year. And as they get more evidence and more reflection, benefit from, obviously, the exchange that occurred with both companies, let's see how that position evolves.

    當然。我認為只是在托尼的觀點的基礎上,我的意思是我希望在這一點上 ACIP 會採取相對保守的立場,但我們要等到明年 6 月。隨著他們獲得更多證據和更多反思,顯然從與兩家公司發生的交流中受益,讓我們看看這種立場是如何演變的。

  • We've done early market research (inaudible) presented by both companies. So that has actually enabled us to do some depth in terms of tracking.

    我們已經完成了兩家公司提出的早期市場研究(聽不清)。所以這實際上使我們能夠在跟踪方面做一些深度。

  • What's interesting is in terms of [ACP], you only see 1 in 4 of their 60-plus patients is actually healthy. So I guess, 3/4 are perceived to be unhealthy. And it's in that population that you actually see the difference start to emerge in terms of perception of these 2 products for the reasons that Tony has said when you look at the efficacy.

    有趣的是,就 [ACP] 而言,您只看到他們的 60 多名患者中有四分之一實際上是健康的。所以我猜,3/4 被認為是不健康的。正是在那個人群中,您實際上看到了對這兩種產品的看法開始出現差異,原因正如托尼在您查看功效時所說的那樣。

  • But I think also critically, again, these are scientifically fluent individuals. They're practicing doctors. They understand confidence intervals. They understand consistency, and they understand and see which of their patients go to hospital each year. So I think that's something we can build on, and we're certainly looking forward to that scientific debate.

    但我認為,同樣重要的是,這些人是科學流利的人。他們在執業醫生。他們了解置信區間。他們了解一致性,他們了解並了解每年有哪些患者去醫院。所以我認為這是我們可以建立的東西,我們當然期待著這場科學辯論。

  • In terms of the ramp, again, there's low levels of awareness amongst potential subjects to be vaccinated. But that will change with 2 companies, obviously, vigorously explaining that. I think some of the press coverage around the results is a good indication of that. Physicians obviously are aware that there's been no solution beyond antibodies in kids. So we expect this understanding will grow. But the ramp will be more consistent and steady over time.

    再次,就坡道而言,潛在接種對象的意識水平較低。但這顯然會隨著兩家公司的大力解釋而改變。我認為圍繞結果的一些新聞報導很好地表明了這一點。醫生們顯然意識到,除了兒童抗體之外,沒有其他解決方案。所以我們預計這種理解會增長。但隨著時間的推移,坡道將更加一致和穩定。

  • I think the Inflation Reduction Act will also help in terms of co-pay reduction, in terms of a single-digit effect, in terms of willingness to get vaccinated. So there's a build over time, but I think it's exciting. And I can imagine this is a class of vaccine that's going to grow over the next 15 years consistently year-on-year globally.

    我認為《減少通貨膨脹法》也將有助於減少共付額,就個位數效應而言,就接種疫苗的意願而言。所以隨著時間的推移會有一個構建,但我認為這很令人興奮。我可以想像這是一類疫苗,將在未來 15 年內在全球範圍內持續增長。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Thanks, Luke. And then I don't know if -- Tony, would you just want to give a very quick view to James' second part of the question on the sort of shift in the portfolio and your priorities there? And then we'll move on because we've a long queue of questions.

    偉大的。謝謝,盧克。然後我不知道是否——托尼,你是否只想快速了解一下詹姆斯關於投資組合轉變的第二部分問題以及你在那裡的優先事項?然後我們將繼續前進,因為我們有一長串問題。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. So look, I mean, this is really for me about a focus on allocation of capital where we see data driving the potential for meaningfully different contribution to standard of care. And I would point to the RSV results we've just been discussing, the emerging profile we have for bepi and, of course, the exciting opportunity we have within the pneumococcal vaccine opportunity based on the Affinivax acquisition. I expect momentum to continue in that part of the portfolio. And that's why you see that 2/3 of our development portfolio is now coming from infectious disease and vaccines.

    是的。所以看,我的意思是,這對我來說真的是關注資本配置,我們看到數據推動了對護理標準做出有意義的不同貢獻的潛力。我要指出我們剛剛討論的 RSV 結果,我們對 bepi 的新興概況,當然還有我們在基於收購 Affinivax 的肺炎球菌疫苗機會中擁有的令人興奮的機會。我預計投資組合的這一部分將繼續保持勢頭。這就是為什麼您會看到我們 2/3 的開發組合現在來自傳染病和疫苗。

  • Operator

    Operator

  • Our second question comes from Simon Baker from Redburn.

    我們的第二個問題來自 Redburn 的 Simon Baker。

  • Simon P. Baker - Head of Pharmaceutical Research

    Simon P. Baker - Head of Pharmaceutical Research

  • On COVID in 2 parts, if I may, please. Firstly, one for Deborah and for Luke, if you could just give us an update on where we are in terms of treatment and diagnosis rates across the key therapeutic areas at this stage in the endemic phase.

    如果可以的話,請分兩部分討論 COVID。首先,對於黛博拉和盧克來說,如果你能告訴我們在流行階段這個階段的關鍵治療領域的治療和診斷率方面的最新情況。

  • And then on Xevudy, it was a very strong performance in the third quarter in contrast to a number of other antibodies in the space. So I just wonder, Tony, if you could update us on the data on efficacy that you have for the latest circulating variant of the Omicron variant. And set against that, you appear to be indicating Q4 sales for Xevudy of close to nothing. I just wondered if you could explain what that was, whether there were orders for Q4 that essentially came into Q3. Just a little bit of color on that would be very helpful.

    然後在 Xevudy 上,與該領域的許多其他抗體相比,第三季度的表現非常強勁。所以我只是想知道,托尼,您是否可以向我們更新您對 Omicron 變體的最新循環變體的功效數據。與此相反,您似乎表明 Xevudy 的第四季度銷售額幾乎為零。我只是想知道您是否可以解釋那是什麼,是否有基本上進入第三季度的第四季度訂單。只是一點點顏色會很有幫助。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Sure. Well, Simon, look, I'll come to Luke first to give you a shape of the Xevudy business, what's happened and what we don't expect ahead. And I think you were asking for commentary from Deborah also. Maybe Luke, you can add to that, what's happening in the overall market in the context of COVID, and we know that that's hit a few areas. And Debbie, you might give a sentence on HIV. And then if there's anything further to add, Tony, on variant switches as this becomes more endemic. Then we should have that at the end. But Luke, first to you.

    當然。好吧,西蒙,聽著,我會先來盧克向你介紹 Xevudy 的業務,發生了什麼以及我們對未來的預期。我想你也在要求 Deborah 發表評論。也許盧克,你可以補充一下,在 COVID 的背景下整個市場正在發生什麼,我們知道這已經影響了幾個領域。還有黛比,你可能會對艾滋病毒作出判決。然後,如果有任何進一步的補充,托尼,關於變體開關,因為這變得更加流行。然後我們應該在最後得到它。但是盧克,首先給你。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Sure, I'll take them. I mean Tony will cover the debate about in vitro versus in vivo activity. But our feedback from physicians actually using the infusion is they still see activity. And so we are still seeing volumes employed and, in some markets, actually (inaudible).

    當然,我會帶走他們。我的意思是托尼將討論關於體外與體內活動的辯論。但是我們從實際使用輸液的醫生那裡得到的反饋是他們仍然看到活動。因此,我們仍然看到使用量,在某些市場上,實際上(聽不清)。

  • Now in terms of extra orders, we're not expecting any in Q4 because governments have stockpiles. The shelf life is 2 years. We're working to extend it to 4 years. So we see it essentially as a saturated market at this point unless there's evolution of the variant.

    現在就額外訂單而言,我們預計第四季度不會有任何訂單,因為政府有庫存。保質期為2年。我們正在努力將其延長至 4 年。因此,除非出現變體的演變,否則我們目前基本上將其視為一個飽和市場。

  • In terms of impact on other areas, I mean, the primary area of suppression remains the ovarian cancer diagnosis, surgery and treatment. It's still down by about 9%. And some signs of recovery but still suppressed.

    就對其他領域的影響而言,我的意思是,抑制的主要領域仍然是卵巢癌的診斷、手術和治療。它仍然下降了約9%。還有一些復甦的跡象,但仍然受到抑制。

  • The rest of the markets, with the exception of China, are essentially starting to revert to the mean, which is encouraging and gives us confidence in terms of the outlook.

    除中國外,其他市場基本上開始回歸均值,這令人鼓舞,也讓我們對前景充滿信心。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Luke. Deborah, any...

    謝謝,盧克。黛博拉,任何...

  • Deborah Jayne Waterhouse - CEO of ViiV Healthcare

    Deborah Jayne Waterhouse - CEO of ViiV Healthcare

  • Yes. So in terms of the HIV market, so the overall TRx market in both Europe and [the U.S.] returned to prepandemic levels and is growing between 1% and 2% overall.

    是的。因此,就 HIV 市場而言,歐洲和 [美國] 的整體 TRx 市場恢復到大流行前的水平,並且總體增長了 1% 到 2%。

  • If we look at the dynamic part of the market, in Europe, you can see that the dynamic part of the market is pretty much back to where it was pre-COVID.

    如果我們看一下歐洲市場的動態部分,您會發現市場的動態部分幾乎回到了 COVID 之前的狀態。

  • In the U.S., the NBRx is weekly. We're around 5,500 to 6,000 prepandemic. They seem to have settled now at about 4,500 per week. So suppressed versus where we were before the COVID pandemic, but I do think this is probably where they've settled. So a slightly less dynamic market. And obviously, we work very hard to create that dynamism with our new portfolio of medicines, which, as you can see, are being very well accepted and have a rapid uptake, both in Europe and in the U.S.

    在美國,NBRx 是每週一次。我們在大流行前大約有 5,500 到 6,000 人。他們現在似乎已經穩定在每週 4,500 人左右。與 COVID 大流行之前的情況相比,我們受到瞭如此壓制,但我確實認為這可能是他們安頓下來的地方。因此,市場活力略顯不足。顯然,我們非常努力地用我們的新藥物組合來創造這種活力,正如你所看到的,這些藥物在歐洲和美國都得到了很好的接受並迅速普及。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Thanks. Tony, anything to add, just on variants?

    偉大的。謝謝。托尼,有什麼要補充的,只是關於變體?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. Just a quick one. The latest real-world evidence from an independent group demonstrates clinical effectiveness of Xevudy through the BA.2 wave, which we believe can be extrapolated to BA.5, which is the currently dominant global subvariant. That's all I have to add.

    是的。只是一個快速的。來自一個獨立小組的最新真實世界證據通過 BA.2 波證明了 Xevudy 的臨床有效性,我們認為這可以外推到 BA.5,這是目前占主導地位的全球子變量。這就是我要補充的。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Okay. Well, I mean, I think just to remind everybody -- I think everyone knows, that no -- that COVID solutions is completely excluded from our guidance in this year and in our 5-year outlook. We've been very proud to contribute billions but mainly the impact for health care through -- and primarily through the pandemic. We're still watching to see what happens endemically. We've got our platform in mRNA, including potentially there, but the world has plenty of COVID vaccines. So this is not at the core of our development plans going forward.

    好的。好吧,我的意思是,我想提醒大家——我想每個人都知道,不——COVID 解決方案完全被排除在我們今年的指導和我們的 5 年展望之外。我們很自豪能夠貢獻數十億美元,但主要是通過——而且主要是通過大流行病對醫療保健產生影響。我們仍在觀察地方性地會發生什麼。我們已經有了 mRNA 平台,包括潛在的,但世界上有大量的 COVID 疫苗。因此,這不是我們未來發展計劃的核心。

  • Operator

    Operator

  • Our next question comes from Richard Parkes from BNP Paribas Exane.

    我們的下一個問題來自 BNP Paribas Exane 的 Richard Parkes。

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

    Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team

  • Got a question for Tony. Just wondered if he could discuss his thoughts on R&D capital allocation in oncology R&D going forward. There's been quite a lot of focus on rebuilding Glaxo -- GSK's presence there over recent years. But it sounds like investment is going to be a bit more selective going forward. I don't know whether I'm interpreting that correctly. But maybe you could just discuss what you think GSK needs in order to compete effectively in oncology, whether it be in terms of technology or capabilities, and how you'd achieve that over time rather than just fully deinvesting.

    有一個問題要問托尼。只是想知道他是否可以談談他對未來腫瘤學研發中研發資金分配的看法。葛蘭素史克(Glaxo)的重建非常受關注——葛蘭素史克(GSK)近年來在那裡的存在。但聽起來未來投資將更具選擇性。我不知道我的解釋是否正確。但也許你可以只討論你認為葛蘭素史克需要什麼才能在腫瘤學領域有效競爭,無論是在技術還是能力方面,以及隨著時間的推移你將如何實現這一目標,而不僅僅是完全撤資。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Thanks. And just as a reminder, we'll come to Tony, and then maybe, Luke, you might want to add something commercially. But our priority has consistently been to grow GSK through innovation in Vaccines and Specialty Medicines. As Tony did say, 2/3 of the pipeline are in infectious diseases and in HIV, but we see oncology as part of what will drive growth at the end of the decade, but I'll let him comment more specifically within oncology. And then Luke, you might want to add on that in terms of commercial, as I know we're excited about what momelotinib might bring next year. So Tony, first to you.

    偉大的。謝謝。提醒一下,我們會來找托尼,然後也許,盧克,你可能想在商業上添加一些東西。但我們的首要任務一直是通過疫苗和特種藥物的創新來發展 GSK。正如托尼所說,2/3 的管道用於傳染病和艾滋病毒,但我們認為腫瘤學是本世紀末推動增長的一部分,但我會讓他更具體地評論腫瘤學。然後盧克,你可能想在商業方面補充一點,因為我知道我們對莫莫替尼明年可能帶來的東西感到興奮。所以托尼,首先給你。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Thanks, Emma. So we're committed to oncology because of persisting medical need and scientific opportunity. And for us really, oncology is in emerging therapeutic area. So you can expect in terms of capital allocation our approach to be a pragmatic one, through careful business development, such as exemplified by the Sierra Oncology deal, and as I mentioned earlier, a focus on assets in the portfolio where we see an opportunity for a meaningful contribution to standard of care. For example, our focus on immuno-oncology in the case of dostarlimab, where we have a number of interesting data sets starting to emerge, and in the CD226 axis, where access to CD96, PVRIG, TIGIT and other members gives us an opportunity for full blockade of that access.

    謝謝,艾瑪。因此,由於持續的醫療需求和科學機會,我們致力於腫瘤學。實際上,對我們來說,腫瘤學正處於新興的治療領域。因此,您可以期望在資本配置方面,我們的方法是務實的,通過謹慎的業務發展,例如 Sierra Oncology 交易,正如我之前提到的,關注投資組合中我們認為有機會的資產對護理標準的有意義的貢獻。例如,我們在 dostarlimab 案例中對免疫腫瘤學的關注,我們有許多有趣的數據集開始出現,在 CD226 軸上,訪問 CD96、PVRIG、TIGIT 和其他成員為我們提供了機會完全封鎖該訪問。

  • So we will continue then to deploy our capital into oncology, driven in the data set -- driven by data, which suggest that we could expect to see meaningfully different clinical contributions.

    因此,我們將繼續將我們的資金投入到腫瘤學中,由數據集驅動——由數據驅動,這表明我們可以期待看到有意義的不同臨床貢獻。

  • As far as the later-stage pipeline is concerned, we're continuing to evaluate Blenrep's potential to make a difference in the treatment of patients with multiple myeloma. And as I mentioned, we expect to be able to report data from D-3 before the end of the year and in DREAMM-7 and DREAMM-8 in second line in 2023.

    就後期管道而言,我們正在繼續評估 Blenrep 在治療多發性骨髓瘤患者方面發揮作用的潛力。正如我所提到的,我們希望能夠在今年年底之前報告 D-3 的數據,並在 2023 年的第二行報告 DREAMM-7 和 DREAMM-8 的數據。

  • Perhaps I'll pause there and pass over to Luke to make any additional comments.

    或許我會在此稍作停頓,讓 Luke 發表任何其他意見。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Sure. Thanks, Tony. I mean, I think, this theme of discipline in terms of competitive profile is something that we spend a lot of time on. I think to build on Tony's point, I would direct you all to the ESMO I-O PERLA publication for the dostarlimab at the end of this year. I think it's got a very intriguing read across the COSTAR study, where there is a chemo dostarlimab arm.

    當然。謝謝,托尼。我的意思是,我認為,在競爭概況方面的紀律主題是我們花費大量時間的事情。我想以 Tony 的觀點為基礎,我會在今年年底向大家介紹 dostarlimab 的 ESMO I-O PERLA 出版物。我認為它在 COSTAR 研究中得到了非常有趣的解讀,其中有一個化療 dostarlimab 臂。

  • And then momelotinib, if you look at the awareness and early market research that we've got, it's very high. There's clearly a lot of enthusiasm around this product. And so we're excited about the filing involved with that product and the potential uptake.

    然後是莫米洛替尼,如果你看看我們的認知度和早期市場研究,它非常高。顯然,人們對這個產品充滿了熱情。因此,我們對該產品所涉及的文件和潛在的吸收感到興奮。

  • Operator

    Operator

  • The following question comes from Stephen Scala from Cowen.

    以下問題來自 Cowen 的 Stephen Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • This is a big picture question for Tony since I believe this is your first quarterly call. But over the past 25 years, GSK has tried many different R&D structures and programs to infuse energy, accountability, creativity. But other than in Vaccines and HIV, none have been particularly successful when compared to leading competitors. Hal made some positive steps, but still outcomes such as otilimab have been far too frequent. So why do you think this has been the case at GSK? Without identifying the root cause, it would seem very difficult to fix.

    這對托尼來說是一個大問題,因為我相信這是您的第一個季度電話會議。但在過去的 25 年裡,葛蘭素史克嘗試了許多不同的研發結構和項目來注入活力、責任感和創造力。但除了疫苗和 HIV 之外,與領先的競爭對手相比,沒有一個是特別成功的。 Hal 取得了一些積極的進展,但像 otilimab 這樣的結果仍然過於頻繁。那麼,為什麼您認為葛蘭素史克會出現這種情況?如果不確定根本原因,似乎很難解決。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Steve. Well, I'll let -- perhaps, Tony, we go straight to you on that. I just would remind everybody, again, on a net basis, we are -- when we look at our outlook for growth, we're in a much better position than we were 5 years ago. We did -- overall, in terms of number of approvals, I think we got to 13. We doubled our number of late-stage assets. And our current momentum as well as our prospects of growth haven't looked stronger.

    謝謝,史蒂夫。好吧,我會讓 - 也許,托尼,我們直接找你。我只想再次提醒大家,在淨基礎上,我們 - 當我們審視我們的增長前景時,我們的處境比 5 年前要好得多。我們做到了——總的來說,就批准數量而言,我認為我們達到了 13 個。我們的後期資產數量增加了一倍。而且我們目前的勢頭以及我們的增長前景看起來並不強勁。

  • Obviously, we have failures because that is the nature of the industry, and I'm really pleased that we call what we don't think we can bring meaningful differentiation. But in terms of your core, big picture questions on operating model, Tony, it would be great to have your reflections at this stage on that, and I'm sure the conversation will continue on the quarters ahead.

    顯然,我們失敗了,因為這是行業的本質,我很高興我們稱之為我們認為無法帶來有意義的差異化。但就運營模式的核心、宏觀問題而言,托尼,在這個階段有你的思考會很棒,我相信未來幾個季度的對話將繼續。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. Thank you, Emma. So let me start by just reiterating that together with Hal, I was a co-architect of the strategy that focuses reiterating the term -- together with Hal, I was a co-architect of the strategy that focuses on science and technology and culture in terms of transforming our business performance. And as Emma has mentioned, we have substantial momentum in that context, particularly our performance with regards to our late-stage portfolio. Our performance of the past year is better than our past, and it's in line with our peers.

    是的。謝謝你,艾瑪。因此,讓我首先重申,與 Hal 一起,我是專注於重申該術語的戰略的聯合架構師 - 與 Hal 一起,我是專注於科技和文化的戰略的聯合架構師改變我們的業務績效的條款。正如艾瑪所提到的,我們在這方面有很大的動力,特別是我們在後期投資組合方面的表現。我們過去一年的表現比過去好,與同行看齊。

  • So what you can expect to see from me and the priorities that I've delineated is a continuing of that focus. I might pick, in particular, on an aspect of culture associated with decision-making, and in particular, improving late-stage [governance]. And there, the focus that you will see on investing capital into assets which have a meaningful opportunity to change standard of care, and that is going to continue to shape our late-stage development portfolio. And the way that you can see it evolving today with us, greater than 60% of our assets now focus on vaccines and infectious disease. So we will continue to focus them.

    因此,您可以期望從我身上看到的以及我所描述的優先事項是繼續關注這一重點。我可能會特別選擇與決策相關的文化方面,特別是改善後期[治理]。在那裡,您將看到將資本投資於具有改變護理標準的有意義機會的資產上的重點,這將繼續塑造我們的後期開發組合。從今天你可以看到它與我們一起發展的方式來看,我們 60% 以上的資產現在都集中在疫苗和傳染病上。因此,我們將繼續關注它們。

  • My priorities again, in terms of technology then, building in additional capabilities and platform technologies. I would remind you that we already have a substantial suite of powerful platform technologies in vaccines. Our adjuvant technology recently added technology for MAPS. And in our medicines portfolio, the growth and effectiveness of a build-in -- build-out and capability in biologics, underscored, for example, by the performance that we demonstrated for Xevudy in bringing that monoclonal quickly to the market. Nucala is an example of a monoclonal and leading in the IL-5 class. And a growing focus now on oligonucleotides, exemplified through the bepirovirsen and other cases in our portfolio.

    我的首要任務是在技術方面,然後構建額外的功能和平台技術。我想提醒你,我們已經擁有一套強大的疫苗平台技術。我們的輔助技術最近增加了 MAPS 技術。在我們的藥物組合中,生物製劑的內建 - 外擴和能力的增長和有效性,例如,通過我們為 Xevudy 展示的將單克隆快速推向市場的表現來強調。 Nucala 是單克隆抗體的一個例子,在 IL-5 類中處於領先地位。現在越來越關注寡核苷酸,例如貝匹羅韋森和我們產品組合中的其他案例。

  • So I'm confident that based on our focus on science, technology and culture and a build-out in technologies, both in platform technology and data technology, you should continue to see the momentum that was built under Hal continue and accelerate.

    因此,我相信,基於我們對科學、技術和文化的關注以及在平台技術和數據技術方面的技術建設,您應該會繼續看到在 Hal 領導下建立的勢頭繼續並加速。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Thanks, Tony. We're going to move to the next questions, and we'll try and speed through as many as we can.

    偉大的。謝謝,托尼。我們將轉到下一個問題,我們將盡可能多地嘗試並加快速度。

  • Operator

    Operator

  • Our next question comes from Graham Parry from Bank of America.

    我們的下一個問題來自美國銀行的 Graham Parry。

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

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

  • Just that you gave us some interesting details on the Zantac litigation and the number of cases. So I just wanted to clarify because I think there might be a bit of confusion out there that you essentially have over 110,000 claimants now. And so 33,000 in the MDL, those are the unfiled claims, and the 77,000, those are filed claims. And can you give us a feel for exactly what the proportion of those are the 5 cancers are outside the MDL?

    只是你給了我們一些關於 Zantac 訴訟和案件數量的有趣細節。所以我只是想澄清一下,因為我認為您現在基本上有超過 110,000 名索賠人可能會有些混亂。因此,MDL 中有 33,000 個是未提交的索賠,而 77,000 個是已提交的索賠。您能否告訴我們這 5 種癌症在 MDL 之外的具體比例是多少?

  • And then secondly, on daprodustat post the data, is that something which you would consider as worth launching in dialysis-dependent only? Or is that an out-licensing candidate given that GSK doesn't really have a cardiorenal franchise? And do you think that is something on which you would be able to make an economic return on the R&D that is invested in it through an out-licensing deal?

    其次,在 daprodustat 發布數據時,您認為這是否值得僅在依賴透析的情況下推出?或者考慮到葛蘭素史克並沒有真正的心腎特許經營權,這是一個外包的候選人嗎?您是否認為您可以通過外包交易從投資研發中獲得經濟回報?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Thanks, Graham. So I'm going to ask Iain, who, alongside our general counsel, both from a governance and a disclosure point of view, is on point for the Zantac work. Just to reiterate, we will always prioritize patient safety. Scientific consensus on this is clear. We're vigorously defending our point, and we're focusing very much on delivering the fundamentals whilst keeping you updated.

    偉大的。謝謝,格雷厄姆。所以我要問伊恩,他和我們的總法律顧問一起,從治理和披露的角度來看,是 Zantac 工作的重點。重申一下,我們將始終將患者安全放在首位。對此的科學共識是明確的。我們正在大力捍衛我們的觀點,我們非常專注於提供基礎知識,同時讓您了解最新情況。

  • But Iain will comment on that, and then we'll ask Luke. And we were pleased with latest feedback from AdCom, but Luke, comment on plans for that. Iain?

    但伊恩會對此發表評論,然後我們會問盧克。我們對 AdCom 的最新反饋感到滿意,但 Luke 對此計劃發表了評論。伊恩?

  • Iain James Mackay - CFO & Executive Director

    Iain James Mackay - CFO & Executive Director

  • Yes. Graham, thanks for the question. So overall, if you look at where we are presently, we've got just over 4,000 cases filed across state and federal. The federal cases are consolidated within that multi-district litigation in the Southern District of Florida.

    是的。格雷厄姆,謝謝你的問題。所以總的來說,如果你看看我們目前的情況,我們在州和聯邦收到了超過 4,000 起案件。聯邦案件合併在佛羅里達州南區的多區訴訟中。

  • At a state level, what we have seen developed over the course of the last few weeks is about 70,000 claims filed in the state of Delaware. And based on the data available, a couple of things. One, the vast majority of those claims have not been vetted at this point in time. So we don't really know much about the claimants' circumstances, whether it's Rx, OTC or anything else actually about the claimants. But what seems to be quite clear is that a significant amount, if not the majority of those, are transfers from the MDL case on the actions of the plaintiffs' lawyers to pursue 5 as opposed to 10 cancers.

    在州一級,我們在過去幾週看到的情況是在特拉華州提交了大約 70,000 份索賠。根據可用的數據,有幾件事。第一,這些索賠中的絕大多數目前尚未經過審查。因此,我們對索賠人的情況知之甚少,無論是 Rx、OTC 還是其他任何關於索賠人的實際情況。但似乎很清楚的是,如果不是其中的大多數,那麼很大一部分是從 MDL 案件中轉移的,原告的律師採取了 5 次而不是 10 次癌症的行動。

  • Now clearly, what is quite important in terms of the MDL case or the Daubert hearings which took place at the end of September and beginning of October, we are hopeful of hearing Judge Rosenberg's decision either later this month or into the month of December. And I think that's quite important in terms of informing how this case then proceeds certainly in the multi-district litigation to federal level, but certainly would also, to some degree, inform what might happen at a state level, most notably within the state of Delaware, where -- which is where the majority of the state cases are now filed.

    現在很明顯,就 MDL 案或 9 月底和 10 月初舉行的 Daubert 聽證會而言,什麼是相當重要的,我們希望在本月晚些時候或 12 月聽到 Rosenberg 法官的決定。而且我認為這對於告知此案如何在多區訴訟中向聯邦一級進行肯定非常重要,但在某種程度上肯定也會告知州一級可能發生的事情,尤其是在州內特拉華州,現在大多數州案件都在這裡提交。

  • In terms of the 33,000 cases sitting within the MDL, those address multiple defendants, including GSK, there are other codefendants within that case. And again, in terms of the numbers of claimants within that class, again, that will be informed by Judge Rosenberg's decision on the Daubert hearings that we'll hopefully hear a little bit later.

    就 MDL 中的 33,000 起案件而言,這些案件涉及多名被告,包括葛蘭素史克,該案件中還有其他共同被告。再一次,就該類別中的索賠人人數而言,這將再次由羅森伯格法官對 Daubert 聽證會的決定提供信息,我們希望稍後會聽到。

  • I think the underpinning on this, Graham, is we still haven't had a single trial in this. The first trial will -- we expect to be in California kicking off in the middle of February. That addresses a single claimant's case. And then we would expect MDL to kick off around the middle of the year and exactly how that plays out will, to a significant degree, be informed by Judge Rosenberg's decision, which we'll hopefully hear reasonably shortly.

    格雷厄姆,我認為這方面的基礎是我們還沒有在這方面進行過一次試驗。第一次審判將——我們預計將於 2 月中旬在加利福尼亞開始。這解決了單個索賠人的情況。然後我們預計 MDL 將在今年年中左右開始,具體的結果將在很大程度上取決於 Rosenberg 法官的決定,我們希望很快就能合理地聽到這一決定。

  • So look, where we are, absolutely no change in sort of the consensus of scientific opinion in terms of no clear evidence and consistency around the connectivity or the causality rather of ranitidine in the form of cancer. And grounded in that, the strength and confidence that gives us we'll continue to defend each case vigorously.

    所以看,我們在哪裡,就沒有明確的證據和一致性或癌症形式的雷尼替丁的因果關係而言,科學觀點的共識絕對沒有改變。並以此為基礎,給我們力量和信心,我們將繼續大力捍衛每一個案件。

  • I think all I would add here is that as matters evolve in this case, we'll continue to provide timely and transparent disclosure, both in terms of the numbers and other developments. So certainly, keep your eyes peeled for any RNSs that we might issue and, obviously, our quarterly disclosures in annual report and accounts. But Graham, hopefully, that's helpful.

    我想我在這裡要補充的是,隨著這種情況的發展,我們將繼續提供及時和透明的披露,包括數字和其他發展。因此,當然,請留意我們可能發布的任何 RNS,顯然,我們在年度報告和賬目中的季度披露。但格雷厄姆希望這會有所幫助。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Thanks. Luke?

    偉大的。謝謝。盧克?

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Thanks, Emma. Graham, so the short answer is yes and yes. So if we do it ourselves, it's financially attractive. We can also do it with a partner and I think make that work. I think our preference is to do it ourselves because of the synergies with Benlysta and various other (inaudible).

    謝謝,艾瑪。格雷厄姆,所以簡短的回答是肯定的。所以如果我們自己做,它在經濟上很有吸引力。我們也可以與合作夥伴一起做,我認為可以做到這一點。我認為我們更喜歡自己做,因為與 Benlysta 和其他各種(聽不清)的協同作用。

  • I mean in the U.S., we are -- if we do get dialysis, and assuming we don't have an onerous REMS program, and I think you're going to see the product evolve in 3 phases. The first phase, which is about 9 months based on CMS cycles, is pre-TDAPA. I don't think you'll see much volume at that point because you're competing with EPOs, which are embedded in the bundle. Then the TDAPA period which will run for about 2 years, and that is essentially where the cost, of course, of the medicine is removed from the bundle. And so there's a strong incentive deliberately created by CMS for the large dialysis organizations, which dominate about 80% of the market in the U.S., to utilize this drug because, of course, the allowance that they have for EPO will be removed from the bundle. The amount they receive for the bundle will not change. So there's a heavy volume incentive for them. That period will run from -- based on our timelines, October 1, 2023 to September 31, 2025.

    我的意思是在美國,如果我們確實進行了透析,並且假設我們沒有繁重的 REMS 計劃,我認為您將看到產品分三個階段發展。第一階段,基於 CMS 週期大約 9 個月,是 TDAPA 之前的階段。我認為那時您不會看到太多交易量,因為您正在與嵌入捆綁包中的 EPO 競爭。然後是大約 2 年的 TDAPA 期限,這基本上是藥物成本從捆綁中扣除的地方。因此,CMS 故意為大型透析組織創造了強烈的激勵機制,這些組織在美國大約 80% 的市場中占主導地位,使用這種藥物,因為當然,他們對 EPO 的補貼將從捆綁中刪除.他們收到的捆綁包金額不會改變。因此,他們有大量的激勵措施。根據我們的時間表,這段時間將從 2023 年 10 月 1 日到 2025 年 9 月 31 日。

  • After that, when it goes back into the bundle, it's very much going to become a volume contracting game in direct competition with EPO, biosimilar EPO. So a tougher game.

    之後,當它重新進入捆綁銷售時,它將成為與 EPO、生物仿製藥 EPO 直接競爭的批量承包遊戲。所以一場更艱難的比賽。

  • Now all of these elements with dialysis don't require large field forces. This is going to be a very concentrated group of people that I could probably count on 2 hands, maybe take one of my shoes off. So a very small infrastructure involved there, for what is net-net from a P&L point of view, quite an attractive asset.

    現在所有這些透析元素都不需要大的場力。這將是一群非常集中的人,我可能會依靠兩隻手,也許會脫掉我的一隻鞋子。所以那裡涉及一個非常小的基礎設施,從損益的角度來看,網絡是一個非常有吸引力的資產。

  • For Europe, we expect to get the broader label. And of course, that's more of a classical non-dialysis build profile. But again, we can embed that with the Benlysta team. And I'd just direct you towards the performance of dapro in Japan, where there's 5 HIPs. It was not the first to launch, but has captured 60% and growing market share. So we think we've got a very competitive profile versus roxadustat in Europe.

    對於歐洲,我們希望獲得更廣泛的標籤。當然,這更像是一個經典的非透析構建配置文件。但同樣,我們可以將其嵌入 Benlysta 團隊。我只是將您引向 dapro 在日本的表現,那裡有 5 個 HIP。它不是第一個推出的,但已經佔據了 60% 的市場份額,並且市場份額不斷增長。因此,我們認為我們在歐洲與 roxadustat 相比具有很強的競爭力。

  • Operator

    Operator

  • Our next question comes from Andrew Baum from Citi.

    我們的下一個問題來自花旗的 Andrew Baum。

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

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • First question to Iain. Iain, you and I have spoken previously about the potential for the MDL to exclude multiple expert witnesses, leading you up into including the MDL being shut down its entirety if all the experts are excluded. Could you tell us from the background knowledge, which I'm sure your Chief Legal Counsel is aware of, any significant prior cases in drug liability litigation where the MDL has been closed that have resulted in significant settlements, including to address the plaintiffs and the state courts. That's the first question.

    伊恩的第一個問題。 Iain,您和我之前曾談到 MDL 可能會排除多名專家證人,如果所有專家都被排除在外,您會認為 MDL 將被完全關閉。您能否從背景知識中告訴我們,我相信您的首席法律顧問知道,MDL 已關閉且導致重大和解的藥物責任訴訟中的任何重大先前案件,包括解決原告和州法院。這是第一個問題。

  • And the second question to Tony. You've taken your TIM-3 cubotumab into Phase III development on the basis of prespecified hurdles for the expansion criteria per protocol. Could you just tell us what those expansion criteria were. And when you referenced the per protocol analysis, is this relation to tax or is this just patients advancing and therefore not being able to take their drugs?

    托尼的第二個問題。根據每個協議擴展標準的預先指定障礙,您已將您的 TIM-3 cubotumab 帶入 III 期開發。你能告訴我們這些擴展標準是什麼嗎?當您參考每個協議分析時,這與稅收有關還是只是患者在進步,因此無法服用他們的藥物?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks. Iain, can you take that and then...

    謝謝。伊恩,你能接受那個然後...

  • Iain James Mackay - CFO & Executive Director

    Iain James Mackay - CFO & Executive Director

  • Yes. Thanks, Andrew. Look, I think as we've talked recently on this topic, there is a range of possible outcomes that Judge Rosenberg will inform in her decision. But the likelihood of it being -- all evidence being excluded and the MDL effectively stopped, we think, is probably very, very low to 0 probability. And frankly, probably unwise of us to try and guess. Rather much more wise to sit and actually await Judge Rosenberg's opinion.

    是的。謝謝,安德魯。聽著,我認為正如我們最近就這個話題所討論的那樣,羅森伯格法官將在她的決定中告知一系列可能的結果。但是,我們認為,所有證據都被排除並且 MDL 有效停止的可能性可能非常非常低到 0。坦率地說,我們嘗試猜測可能是不明智的。坐下來等待羅森伯格法官的意見要明智得多。

  • In terms of precedent, there are clearly instances and other product liability cases where Daubert hearings and other forms of hearings, like the Sargon hearings in California, narrowed the scope of the possible prosecution and evidence that can be submitted both interestingly by plaintiffs and defendants lawyers.

    就先例而言,在某些情況和其他產品責任案件中,Daubert 聽證會和其他形式的聽證會,如加利福尼亞州的 Sargon 聽證會,顯然縮小了原告和被告律師都可以提交的可能起訴和證據的範圍.

  • So there is a range of practice in this. I don't think we have any expectation that the MDL all evidence will be excluded when the MDL suppressed. I think that would be unlikely. But we are going to save our counsel and await to hear from Judge Rosenberg. I think that's the best approach here.

    所以在這方面有一系列的實踐。我不認為我們有任何期望,當 MDL 被壓制時,MDL 的所有證據都將被排除。我認為這不太可能。但我們將保留我們的律師並等待羅森伯格法官的答复。我認為這是這裡最好的方法。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Iain. Tony on (inaudible).

    謝謝,伊恩。托尼(聽不清)。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. So thank you, Andrew. First of all, I would say I'm happy with the progression of COSTAR into Phase III on basis of the IDMC recommendation. I don't want to disclose the details of our clinical trial, I'm looking forward to wait and see what the data is.

    是的。所以謝謝你,安德魯。首先,我想說我很高興根據 IDMC 的建議將 COSTAR 推進到 III 期。我不想透露我們臨床試驗的細節,我期待著等待看看數據是什麼。

  • Operator

    Operator

  • The following question comes from Keyur Parekh from Goldman Sachs.

    以下問題來自高盛的 Keyur Parekh。

  • Keyur Parekh - Equity Analyst

    Keyur Parekh - Equity Analyst

  • Two, if I may, please. The first one, just on the kind of ramp for the RSV vaccine and how you anticipate kind of launching it U.S. and ex U.S. With Shingrix, we saw kind of a staggered launch due to supply constraints. But just wondering kind of when you see this -- how do you see the trajectory of launch? And what should we be anticipating as regards to kind of the length of time it takes before you get to kind of your peak sales outlook for the molecule?

    二,如果可以的話,請。第一個,只是在 RSV 疫苗的那種坡道上,以及你如何預期在美國和美國以外的地方推出它。隨著 Shingrix,由於供應限制,我們看到了一種交錯的推出。但只是想知道當你看到這個時——你如何看待發射的軌跡?在您達到該分子的峰值銷售前景之前,我們應該期待什麼?

  • And then separately, Tony, kind of big picture for you. Again, kind of coming back to R&D and culture and organization. What are some of the things we should expect from you that might be different to what prior GSK management have done from an R&D perspective? And what's kind of your broader picture for how you would define success for GSK R&D over the next 12 to 24 months?

    然後分別,托尼,對你來說有點大局。再次回到研發、文化和組織。從研發的角度來看,我們應該從您那裡得到哪些與之前葛蘭素史克管理層所做的不同的事情?您如何定義未來 12 到 24 個月 GSK 研發的成功?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Right. So look, what you recognized, it's a competitive situation. Over to you first on RSV (inaudible).

    正確的。所以看,你所認識到的,這是一個競爭的局面。 RSV(聽不清)先交給你。

  • Iain James Mackay - CFO & Executive Director

    Iain James Mackay - CFO & Executive Director

  • Sure. Thanks, Keyur. We have no supply constraints within reason. So unlike Shingrix, where a delivery decision was made to impair launches to direct supply to the U.S. in earlier launch markets, we will go for a full global launch. There is some gating, of course, just from a resource point of view.

    當然。謝謝,凱爾。我們在合理範圍內沒有供應限制。因此,與 Shingrix 不同的是,Shingrix 的交付決定是為了在早期的發射市場中影響發射以直接向美國供應,我們將進行全面的全球發射。當然,僅從資源的角度來看,存在一些門控。

  • The ramp, I would expect to be quite steady. It's -- the peak for the U.S. is after 5 years. Globally, it's going to be closer to 10 years just because of building the market. But as I said, I would expect that this product grows throughout its life cycle. It should just continue building and building as we see penetration in markets across the globe.

    坡道,我希望會很穩定。這是 - 美國的高峰是 5 年後。在全球範圍內,僅僅因為建立市場,這將接近 10 年。但正如我所說,我希望該產品在其整個生命週期中不斷增長。隨著我們看到全球市場的滲透,它應該繼續建設和建設。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Yes. And the last point on this one is, of course, we will still see the data prove out how long the duration of efficacy is and the frequency of re-protection. Tony.

    是的。而關於這一點的最後一點,當然,我們還是會看到數據證明藥效的持續時間和再保護的頻率。托尼。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. Thank you. So 2 points on that one. First of all, I would point again to portfolio decisiveness and decision-making. In particular, you should expect to continue to see a focus on those assets whose profile is consistent with a material contribution to standard of care, an acceleration of early-stage assets based on data and the continued focus on business development.

    是的。謝謝你。所以2分。首先,我要再次指出投資組合的決定性和決策。特別是,您應該期望繼續關注那些其概況與對護理標準的重大貢獻一致的資產、基於數據的早期資產加速以及對業務發展的持續關注。

  • As far as impact on the broader R&D culture is concerned, then it's doubling down on technology in particular to drive performance within R&D. And you should expect to see examples of how that technology deployment, be it against platform or data, is improving the overall characteristics of the portfolio.

    就對更廣泛的研發文化的影響而言,它在技術上加倍下注,特別是在研發中推動績效。您應該期望看到該技術部署(無論是針對平台還是數據)如何改善投資組合的整體特徵的示例。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Tony. And the measures of success, let's be clear, are the strength of the pipeline and the prospects for growth -- profitable growth it generates. So right, next question, please.

    謝謝,托尼。讓我們明確一點,衡量成功的標準是管道的實力和增長前景——它產生的盈利增長。對了,請下一個問題。

  • By the way, our proposal is for anyone that's worried about not getting through all the questions that we will extend the call by an extra 10 minutes so we can get to everybody. So next one, please.

    順便說一句,我們的建議是針對那些擔心無法解決所有問題的人,我們會將通話時間再延長 10 分鐘,這樣我們就可以聯繫到所有人。所以請下一個。

  • Operator

    Operator

  • Our next question comes from Jo Walton from Credit Suisse.

    我們的下一個問題來自瑞士信貸的 Jo Walton。

  • Jo Walton - MD

    Jo Walton - MD

  • Thank you. I'll respect the one-question rule here and ask a little bit more on Shingrix. Could you give us an idea of the level of inventory at the end of the third quarter in the U.S.? I believe it was 1.9 million doses in the second quarter. And if you can tell us a little bit about the penetration in other markets. You've talked in the past about Germany and Canada as being the main 2 markets, but you're in more than 30. So can you talk about where you've got good penetration? What sort of level of annual cohort you might expect to be able to be getting to in some of these other non-U.S. markets?

    謝謝你。我會尊重這裡的一個問題規則,並在 Shingrix 上多問一點。您能否介紹一下美國第三季度末的庫存水平?我相信第二季度是 190 萬劑。如果你能告訴我們一些關於其他市場的滲透情況。您過去曾談到德國和加拿大是主要的兩個市場,但您已經超過 30 個。那麼您能談談您在哪些方面的滲透率很高嗎?在其他一些非美國市場中,您可能期望能夠達到什麼樣的年度隊列水平?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Over to you, Luke.

    偉大的。交給你了,盧克。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Sure, Jo. So I mean, yes, 1.8 in Q3, which compares to 1 in Q3 last year. But you would have seen the latest TRx as we just hit 200,000 last week. So good in-market demand. In Q3 in actual dose is about 6.3 million sold. So consistent demand which is very deliberate. We wanted to smooth the process over the year and not have it aggressively concentrated around the flu season. I think we're proving to do that. Because if you look, Q1 was 6.6, Q2 was 6.5, Q3 was 6.3.

    當然,喬。所以我的意思是,是的,第三季度為 1.8,而去年第三季度為 1。但是您會看到最新的 TRx,因為我們上周剛剛達到 200,000。如此良好的市場需求。第三季度實際銷售量約為 630 萬。如此一致的需求是非常刻意的。我們希望在這一年中順利進行這一過程,而不是將其集中在流感季節前後。我認為我們正在證明這樣做。因為如果你看,第一季度是 6.6,第二季度是 6.5,第三季度是 6.3。

  • In terms of outside, you saw on the slide that I presented that you've got this growing European and international presence. And a critical point to make here, if you look at price variance globally, it's around 5% from the U.S. on average. So we've been able to preserve this pricing power so far at this point in the life cycle.

    在外部方面,您在我展示的幻燈片中看到,您在歐洲和國際上的影響力不斷增長。在這裡要指出的一個關鍵點是,如果你看一下全球的價格差異,平均而言,它與美國的價格差異約為 5%。因此,到目前為止,我們已經能夠在生命週期的這個階段保持這種定價能力。

  • So German demand remains very strong. We're starting now in Spain, Italy. We're about to announce a major contract in one of the key European markets. There are full reimbursement. And so, yes, we continue to see very positive signs. And the aim of course is to have this market completely treated with a 10-year plus and evolving efficacy before anyone else gets close to launching.

    因此,德國的需求仍然非常強勁。我們現在從西班牙、意大利開始。我們即將在一個主要的歐洲市場宣布一項重要合同。有全額報銷。所以,是的,我們繼續看到非常積極的跡象。當然,目標是在其他任何人接近推出之前,用 10 年以上的時間和不斷發展的功效徹底對待這個市場。

  • Now, I spent time in emerging markets in August. It's quite encouraging what we see early days with Brazil. Obviously, we don't expect to see levels of penetration that we may reach in the U.S. over the next couple of years, but we also have the flexibility to adjust that price down in the back end of the life cycle to catch those patients who may not be seeking vaccination at this point in the out-of-pocket markets, in emerging markets as well. So there's plenty of flexibility in terms of the structure and how we're positioning this vaccine for multiple year growth.

    現在,我在八月份在新興市場度過了一段時間。我們在巴西早期看到的情況非常令人鼓舞。顯然,我們預計未來幾年我們在美國的滲透率不會達到,但我們也可以靈活地在生命週期的後端調整價格,以抓住那些目前可能不會在自付費用市場以及新興市場尋求疫苗接種。因此,在結構以及我們如何定位這種疫苗以實現多年增長方面有很大的靈活性。

  • Operator

    Operator

  • Next is Tim Anderson from Wolfe Research.

    接下來是來自 Wolfe Research 的 Tim Anderson。

  • Timothy Minton Anderson - MD of Equity Research

    Timothy Minton Anderson - MD of Equity Research

  • My question is kind of cash flows and business development. So one of the challenges Glaxo faced your past is weak cash flow, limited business development activity. That improved after spinning out consumer and cutting the dividend. But I'm wondering if business development in the form of acquisitions specifically could get put on hold again, given uncertainty around Zantac. Because it's not inconceivable that at some point, you have to take financial reserves seeing that the drug was pulled off the market. So if the answer to my question is there's no change, it's business as usual, maybe you can bracket the upper end of deal sizes you'll continue to look at.

    我的問題是現金流和業務發展。因此,葛蘭素史克過去面臨的挑戰之一是現金流疲軟,業務發展活動有限。在剝離消費者並削減股息後,情況有所改善。但我想知道,鑑於 Zantac 的不確定性,以收購為形式的業務發展是否會再次被擱置。因為在某些時候,看到藥物被撤出市場,你必須拿出財政儲備並不是不可想像的。因此,如果我的問題的答案是沒有變化,一切照舊,也許您可以將您將繼續關注的交易規模的上限括起來。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Right. Well, first of all, I want to be absolutely categorically clear. We will, as always planned, continue to pursue business development with agility, ambition and appropriate aggression and due discipline from a financial point of view. There is absolutely no change to our intentions there, as articulated also by Tony, and from a capital allocation point of view from Iain.

    正確的。好吧,首先,我想絕對明確。我們將一如既往地從財務角度繼續以敏捷、雄心和適當的進取心和應有的紀律追求業務發展。正如托尼(Tony)和伊恩(Iain)從資本配置的角度所闡述的那樣,我們在那裡的意圖絕對沒有改變。

  • This is, as you rightly acknowledged, exactly why we went through significant structural reset of the balance sheet of GSK. But I'd also point as to the improving operating performance generation of cash flow as well as continually competitive distribution but also some of the pay down of debt. And of course, in brackets, we are helped by currencies.

    正如您正確承認的那樣,這正是我們對葛蘭素史克資產負債表進行重大結構性調整的原因。但我還要指出現金流的改善經營業績的產生以及持續競爭的分配以及一些債務的償還。當然,在括號中,我們得到了貨幣的幫助。

  • And it's really important that this is understood that we are absolutely focused with support to keep prioritizing BD as part of our pipeline development mainly for continued profitable growth in the end of the decade. We're very confident in our outlook. We'll stay disciplined on it. But that is the very clear intent and plan forward.

    理解這一點非常重要,我們絕對專注於支持繼續優先考慮 BD 作為我們管道開發的一部分,主要是為了在本世紀末持續盈利增長。我們對我們的前景非常有信心。我們將保持紀律性。但這是非常明確的意圖和前進計劃。

  • Iain, I don't know if there's anything you want to add.

    伊恩,我不知道你有什麼要補充的。

  • Iain James Mackay - CFO & Executive Director

    Iain James Mackay - CFO & Executive Director

  • I'm not sure there is much I'd actually add. We've got a stronger balance sheet. We've got strong cash flow. We did a reset on the dividend, with good cover of that dividend from '23 onwards. Strong focus on cash generation, cash management across the business. And to Emma's point around business development and M&A, continued focus around there's bolt-on acquisitions of (inaudible) that we've done over the course of the last few years.

    我不確定我實際上要添加多少。我們擁有更強大的資產負債表。我們有強勁的現金流。我們對股息進行了重置,從 23 年開始就很好地覆蓋了股息。重點關注現金產生和整個業務的現金管理。對於艾瑪關於業務發展和併購的觀點,繼續關注我們在過去幾年中完成的(聽不清)收購。

  • So absolutely no change. And there is not a Zantac overlay at this stage for the obvious reason that we believe there's a very strong consensus of scientific evidence supporting our position. And we're going to -- we're going to defend our claims very vigorously in that front. So absolutely no change in capital allocation priorities. None.

    所以絕對沒有變化。並且在這個階段沒有 Zantac 覆蓋,原因很明顯,我們相信有一個非常強烈的科學證據共識支持我們的立場。我們將 - 我們將在這方面非常積極地捍衛我們的主張。因此,資本配置優先級絕對沒有變化。沒有任何。

  • Operator

    Operator

  • Moving to Peter Welford from Jefferies.

    從 Jefferies 搬到 Peter Welford。

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

    Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst

  • Just a point of clarification really on Zantac, which is just given the commentary you made with regards to the MDL and how Daubert decision will inform how it proceeds. Just curious, is that an event that the auditors or I guess, Iain, consider then the time to consider a provision? Or will that likely wait for the bell weather?

    只是關於 Zantac 的一點澄清,它只是給出了你對 MDL 的評論以及 Daubert 的決定將如何影響它的進展。只是好奇,這是審計員或我猜的事件,Iain,考慮當時考慮條款的時間嗎?或者這可能會等待鐘聲?

  • And then if I could just ask just on RSV, coming back to what Luke was saying with regards to competitive positioning. Obviously, we've also seen data from Pfizer now and in their meningococcal vaccine. I guess curious any view on that? And particularly how that potentially could impact your positioning of the product in the retail segment in the U.S., which I think you said is very important on the prior call, given obviously that now has 2 populations potentially that could be addressed in the U.S. with that vaccine.

    然後如果我可以只問 RSV,回到盧克關於競爭定位的說法。顯然,我們現在也看到了輝瑞公司及其腦膜炎球菌疫苗的數據。我想對此有什麼看法?尤其是這可能如何影響您在美國零售領域的產品定位,我認為您在之前的電話會議上說這非常重要,因為顯然現在有兩個人群可以在美國解決疫苗。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • I suspect (inaudible) be on the press release on Zantac, but Iain might want to add to that. And then on other people's vaccines, but Luke may want to talk about the commercial prospects there.

    我懷疑(聽不清)在 Zantac 的新聞稿中,但 Iain 可能想補充一下。然後是其他人的疫苗,但盧克可能想談談那裡的商業前景。

  • Iain James Mackay - CFO & Executive Director

    Iain James Mackay - CFO & Executive Director

  • Yes. On Daubert, Peter, it informs what test (inaudible) can be submitted in evidence both by plaintiffs and defendants' counsel and possibly the scope of the MDL that will take place in the middle of next year. It doesn't inform anything else. And therefore, viewing that as definitive. Or it absolutely isn't definitive. We have to go to court to try the case and we'll defend ourselves vigorously in that matter. Depending on the outcome of it, then we'll consider whether or not any provisioning may be appropriate at that time. But no, I don't think Daubert is an inflection point in that regard at all.

    是的。關於 Daubert,Peter,它告知原告和被告的律師可以提交哪些測試(聽不清)作為證據,以及可能在明年年中進行的 MDL 的範圍。它不會通知其他任何事情。因此,將其視為確定的。或者它絕對不是確定的。我們必須上法庭審理此案,我們將在這件事上為自己辯護。根據它的結果,然後我們將考慮當時是否有任何配置合適。但不,我認為 Daubert 在這方面根本不是一個轉折點。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes. I think these 2 populations are going to be separated. Again, it's going to come back to the efficacy in the group's most at risk. And I think the numbers are quite illustrative, it's about 80 million people who were 60-plus who are either co-morbid or 65-plus versus the birth cohort of about 4 million in the U.S. each year. So I think it's quite manageable, and that's assuming that it's approved, of course.

    是的。我認為這兩個群體將被分開。再次,它將恢復對風險最大的群體的療效。我認為這些數字很能說明問題,大約有 8000 萬 60 歲以上的人患有合併症或 65 歲以上,而美國每年約有 400 萬出生隊列。所以我認為這是可以管理的,當然,這是假設它已獲得批准。

  • Operator

    Operator

  • Our next question comes from Kerry Holford from Berenberg.

    我們的下一個問題來自貝倫貝格的 Kerry Holford。

  • Kerry Ann Holford - Analyst

    Kerry Ann Holford - Analyst

  • My question is on your meningitis vaccine franchise. So your competitive Pfizer has announced positive Phase III headlines for its bivalent vaccine and aims to file before the end of the year. You're confirming today that your Phase III data is due by year-end. If that is positive, how quickly can you move to file? Obviously, you have more to lose in this market and Pfizer has more to gain. So how comfortable are you that you can protect and indeed grow your position beyond Bexsero and Menveo.

    我的問題是關於你們的腦膜炎疫苗特許經營權。因此,您的競爭對手輝瑞(Pfizer)已宣布其二價疫苗的積極 III 期頭條新聞,併計劃在年底前提交申請。您今天確認您的第三階段數據將在年底前到期。如果這是肯定的,您可以多快移至歸檔?顯然,在這個市場上你會失去更多,而輝瑞會獲得更多。那麼,在 Bexsero 和 Menveo 之外,您可以保護並確實擴大您的地位,您有多舒服。

  • And slightly different but related question, perhaps you can also remind me of the difference between your Generation 1 and 2 pipeline candidates in Cervarix.

    和略有不同但相關的問題,也許您還可以提醒我您在 Cervarix 中的第 1 代和第 2 代管道候選者之間的區別。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Well, Tony, perhaps you can comment on timing to file and Gen 1 and 2. And then Luke will come to you on, I know, very strong ambitions and prospects there.

    好吧,托尼,也許你可以評論一下提交時間和第一代和第二代。然後盧克會來找你,我知道,那裡有非常強烈的野心和前景。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. So thank you, Emma. Look, as I mentioned earlier, we're confident the program is on track with regard to the data, and we're preparing to move to file post that as quickly as possible.

    是的。所以謝謝你,艾瑪。看,正如我之前提到的,我們相信該程序在數據方面處於正軌,我們正準備盡快將其轉移到文件發布。

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes. And I just built, in terms of the first generation asset, I think the important component is, and we published on this, is the 110 strain coverage which is -- we believe strongly in terms of provide better protection.

    是的。我剛剛建立,就第一代資產而言,我認為重要的組成部分是,我們對此發表了,是 110 應變覆蓋範圍,我們堅信可以提供更好的保護。

  • The generation 1 is really a U.S.-targeted vaccine. We don't see the -- because in Europe, it's largely an infant population we see Bexsero being preserved and used in a mono setting. The pentavalent is very much targeting U.S. adolescents, college-age kids. And the penetration of Bexsero in there is still relatively early days. So we think the shift to the pentavalent and the better be embedded there will be a very competitive opportunity.

    第一代實際上是針對美國的疫苗。我們看不到——因為在歐洲,我們看到 Bexsero 主要是嬰兒群體,被保存並用於單聲道環境。五價廣告主要針對美國青少年和大學年齡的孩子。而Bexsero在其中的滲透還比較早。所以我們認為向五價的轉變和更好的嵌入將是一個非常有競爭力的機會。

  • So it's not cannibalistic. It's an opportunity to grow the aggregate business there in the U.S. Then the Generation 2 has the potential to be utilized more broadly.

    所以它不是同類相食。這是在美國發展綜合業務的機會。那麼第 2 代有可能得到更廣泛的利用。

  • And then the final thing I would direct you to, which we need to build the evidence for this and ultimately find a pathway for a label, is the activity around gonorrhea. And I think there's an excellent analogue with Merck's excellent work with Cervarix around HPV and genital warts. And again, when you look at gonorrhea, I think it's about 85 million, 83 million new cases in the U.S. every year. College-age kids, of course, by nature of the lifestyle point of age at high risk. So we think these elements combined are very compelling. And that last activity around gonorrhea, we don't believe is accessible to the Pfizer meningitis vaccine.

    然後我要指導您做的最後一件事是圍繞淋病開展的活動,我們需要為此建立證據並最終找到標籤的途徑。而且我認為默克公司與 Cervarix 在 HPV 和生殖器疣方面的出色工作有一個很好的相似之處。再說一次,當你看淋病時,我認為美國每年大約有 8500 萬、8300 萬新病例。大學年齡的孩子,當然,在高風險的年齡點的生活方式。所以我們認為這些元素結合起來非常引人注目。最後一項圍繞淋病的活動,我們認為輝瑞腦膜炎疫苗無法獲得。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Great. Thanks, Luke.

    偉大的。謝謝,盧克。

  • Operator

    Operator

  • The following question comes from Michael Leuchten from UBS.

    以下問題來自瑞銀的 Michael Leuchten。

  • Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research

    Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research

  • Just a quick follow-up, just going back to Shingrix and the stocking levels. I think in Q2, you were pointing out that inventory levels were running quite high. It sounds like they still are, but you're comfortable with that going forward? Or should we expect there to be a work down as we go into the flu season?

    只是快速跟進,回到 Shingrix 和庫存水平。我認為在第二季度,您指出庫存水平很高。聽起來他們仍然是,但你對未來感到滿意嗎?還是我們應該期望在進入流感季節時會有所緩解?

  • Luke V. Miels - Chief Commercial Officer

    Luke V. Miels - Chief Commercial Officer

  • Yes, Michael, comfortable. I mean, they kept ordering. And I've said this in the past, and it remains true, they order it because they're confident in using it and the script trends are certainly pointing that way. And actually, we've seen a strong jump in non-retail utilization, which is not as visible to you guys. So the volume growth are very encouraging. So not concerned with the Q3 inventory level.

    是的,邁克爾,舒服。我的意思是,他們一直在訂購。我過去曾說過,這仍然是正確的,他們訂購它是因為他們有信心使用它,而且劇本趨勢肯定是這樣指向的。實際上,我們已經看到非零售利用率的強勁增長,這對你們來說並不那麼明顯。因此,銷量增長非常令人鼓舞。所以不關心第三季度的庫存水平。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • We've got 2 more questions.

    我們還有 2 個問題。

  • Operator

    Operator

  • Our next question comes from Emmanuel Papadakis from Deutsche Bank.

    我們的下一個問題來自德意志銀行的 Emmanuel Papadakis。

  • Emmanuel Douglas Papadakis - Research Analyst

    Emmanuel Douglas Papadakis - Research Analyst

  • Perhaps a question on mRNA. You highlighted several times in the Q3 release the priority investment in mRNA. And I assume that would be principally into the flu partnership and COVID partnership with (inaudible) but perhaps you can correct if that's otherwise. And are we still expecting Phase I data for both modified and unmodified through assets by the end of this year? And what's your degree of confidence both in seeing an improved risk benefit profile relative to competitive data sets we've seen over the last 12, 18 months, particularly as regards to reactogenicity and your confidence that you've got the right external technology partner for that platform.

    也許是關於 mRNA 的問題。您在第三季度發布中多次強調了對 mRNA 的優先投資。我認為這主要是與流感合作夥伴關係和 COVID 合作夥伴關係(聽不清),但如果不是這樣,也許你可以糾正。我們是否仍然期待在今年年底前通過資產修改和未修改的第一階段數據?相對於我們在過去 12、18 個月中看到的競爭性數據集,尤其是在反應原性方面,您對看到風險收益狀況有所改善的信心程度如何,以及您對擁有合適的外部技術合作夥伴的信心那個平台。

  • And then a very quick follow-up on royalties, if I may. Big step up this quarter. Apologies if I missed it earlier. Is that the kind of run -- didn't seem to call out any one-off, is that the kind of run rate we should be thinking about going forward?

    如果可以的話,然後快速跟進版稅。本季度大幅提升。抱歉,如果我早些時候錯過了它。是那種跑——似乎沒有叫任何一次性的,這是我們應該考慮前進的那種跑速嗎?

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Right. Well, Iain, can you just pick up the royalties one. And then Tony, we'll come to you on mRNA.

    正確的。好吧,伊恩,你能不能拿個版稅。然後托尼,我們會在 mRNA 上找你。

  • Iain James Mackay - CFO & Executive Director

    Iain James Mackay - CFO & Executive Director

  • The Royalties is the principal combination of Gardasil and Biktarvy settlement. Those are the 2 key elements. And obviously, the Biktarvy settlement took effect in February of this year. So we're probably hitting an appropriate run rate, but it's informed by sales of Biktarvy.

    版稅是 Gardasil 和 Biktarvy 結算的主要組合。這些是 2 個關鍵要素。顯然,Biktarvy 和解協議於今年 2 月生效。所以我們可能會達到一個合適的運行速度,但它是由 Biktarvy 的銷售情況決定的。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. Thank you, Emma. So in flu, our studies remain on track. I would remind you that we have a suite of clinical studies aimed at assessing optimization of sequence and the incorporation of modified basis in both the context of COVID and in the context of flu as well as an internal build, which is continuing at pace. So I'm confident that when you put all 3 of those together, we are well placed to be able to solve the equation associated with getting to an appropriate reactogenicity versus efficacy proposition for a multivalent flu vaccine. We'll know clear how that stands, certainly by the end of the second half of next year -- sorry, the end of the first half of next year.

    是的。謝謝你,艾瑪。因此,在流感方面,我們的研究仍在進行中。我想提醒您,我們有一套臨床研究,旨在評估序列優化和在 COVID 和流感背景下納入改良基礎以及內部構建,這正在繼續進行。因此,我相信,當您將所有這三個因素放在一起時,我們完全有能力解決與獲得適當的反應原性與多價流感疫苗功效命題相關的方程式。我們會清楚地知道情況如何,肯定會在明年下半年結束 - 對不起,明年上半年結束。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Thanks, Tony. Okay. Last question, please.

    謝謝,托尼。好的。請問最後一個問題。

  • Operator

    Operator

  • Our final question comes from Emily Field from Barclays.

    我們的最後一個問題來自巴克萊的 Emily Field。

  • Emily Field - Research Analyst

    Emily Field - Research Analyst

  • Hopefully, first, it's a very quick clarification on Zantac and the impact of Daubert. You mentioned that a number of these cases in Delaware where plaintiffs moving jurisdiction from the MDL to Delaware. I was just wondering whatever comes out of Daubert, will that have any impact on any other jurisdictions like such as these state courts? i.e., if cancer is reduced in the MDL via Daubert, would that then have any impact on state cases?

    希望首先,這是對 Zantac 和 Daubert 影響的快速澄清。您提到特拉華州的許多此類案件中,原告將管轄權從 MDL 轉移到特拉華州。我只是想知道 Daubert 的結果是什麼,這會對像這些州法院這樣的任何其他司法管轄區產生任何影響嗎?即,如果通過 Daubert 減少 MDL 中的癌症,那麼這會對州病例產生任何影響嗎?

  • And then I actually just wanted to ask a question on the recent -- looks like recent decision to move the anti-TIGIT asset into Phase II. If you could just comment sort of on the thinking behind that sort of as we're all awaiting the (inaudible) updated (inaudible) data, and it does look like an interesting trial design given that you also have a pembro arm in there sort of in the context of the PERLA study. So just any color or commentary around that would be helpful.

    然後我實際上只是想問一個關於最近的問題——看起來最近決定將反 TIGIT 資產轉移到第二階段。如果您可以評論一下這種背後的想法,因為我們都在等待(聽不清)更新的(聽不清)數據,而且它看起來確實是一個有趣的試驗設計,因為您那裡還有一個 pembro 手臂在 PERLA 研究的背景下。因此,任何顏色或評論都會有所幫助。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Right. Thanks. So Iain, swiftly on Daubert again. And then Tony to finish up, please.

    正確的。謝謝。所以,伊恩,又一次迅速地在道伯特身上。然後托尼結束,拜託。

  • Iain James Mackay - CFO & Executive Director

    Iain James Mackay - CFO & Executive Director

  • Sure. Emily, thanks for the question. At a state level, they're not bound by decisions at federal level. And Daubert is informing the scope (inaudible) district litigation in the Southern District of Florida.

    當然。艾米麗,謝謝你的問題。在州一級,他們不受聯邦一級決定的約束。 Daubert 正在通知佛羅里達州南區的範圍(聽不清)地區訴訟。

  • So the states can take a different view. What is interesting based on history is that Delaware has tended to follow precedents set by federal -- by federal courts. So it is possible that the Daubert hearings would have (inaudible) specifically related to multi-district litigation in the Southern District of Florida in federal court. It is possible that the output of Daubert could also have a read across to state cases and at state level, probably notably in Delaware, where we currently have about 70,000 claims filed, of which the vast majority is yet unvetted. So we know little about them other than the fact that they probably relate to 5 cancers that the plaintiffs (inaudible) in the MDL decided not to pursue. So that's probably all -- that's all I can add on that point at the most, Emily. Hopefully, that's helpful.

    因此,各州可以採取不同的看法。根據歷史,有趣的是特拉華州傾向於遵循聯邦 - 聯邦法院設定的先例。因此,Daubert 聽證會可能(聽不清)與佛羅里達州南區聯邦法院的多區訴訟特別相關。 Daubert 的輸出也有可能在州級案件中被解讀,尤其是在特拉華州,我們目前有大約 70,000 份索賠,其中絕大多數尚未經過審查。所以我們對它們知之甚少,除了它們可能與 MDL 中的原告(聽不清)決定不追究的 5 種癌症有關。所以這可能就是全部——這就是我最多可以補充的,艾米麗。希望這會有所幫助。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • So Tony, TIGIT.

    所以托尼,TIGIT。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. Thanks, Emily. Obviously, TIGIT is an incredibly competitive class with more than 20 assets in development. And for that reason, it's going to be important for us to move at pace since the change that you see. It's likely that certain assets are going to have dominant positions in certain indications, given combination partners and others.

    是的。謝謝,艾米麗。顯然,TIGIT 是一個極具競爭力的類別,擁有超過 20 項正在開發的資產。出於這個原因,自您看到的變化以來,我們必須跟上步伐。考慮到組合合夥人和其他人,某些資產可能會在某些跡像中佔據主導地位。

  • I don't really want to disclose about where we may compete. But the movement that you see is consistent with that. And also building out a Phase II platform capability to be able to evaluate not only doublet in the PD-1 TIGIT access, but other alternatives in combination, as I mentioned earlier, like CD96 and (inaudible).

    我真的不想透露我們可能在哪裡競爭。但你看到的運動與此一致。並且還構建了 II 期平台能力,不僅能夠評估 PD-1 TIGIT 訪問中的雙聯體,而且還能夠評估其他組合的替代方案,如我之前提到的,如 CD96 和(聽不清)。

  • Emma Natasha Walmsley - CEO & Director

    Emma Natasha Walmsley - CEO & Director

  • Right. Well, a big thank you to everybody. I hope you got to most people's questions, we will certainly be following up in coming days. We are delivering our landmark year with this another quarter of strong performance, upgraded guidance and great momentum, including on the pipeline. So we're very much on track to meet our board ambitions for this year, for our 5-year outlook and the days of the decade ahead. Thank you very much, everyone. Speak to you soon.

    正確的。嗯,非常感謝大家。我希望你能回答大多數人的問題,我們肯定會在未來幾天跟進。我們正在迎來具有里程碑意義的一年,又一個季度表現強勁,指引升級,勢頭強勁,包括正在籌備中。因此,我們非常有可能實現董事會今年、5 年展望和未來十年的目標。非常感謝大家。盡快回复你。

  • Operator

    Operator

  • Thank you for joining, everyone. That concludes your conference. You may now disconnect. Please enjoy the rest of your day. Goodbye.

    謝謝大家的加入。您的會議到此結束。您現在可以斷開連接。請盡情享受您的一天。再見。