GSK plc

Hello, everyone. Welcome to today's call and webcast. The presentation was sent to our distribution list by email today, and you can also find it on gsk.com. Please turn to slide two. This is the usual safe harbor statement. We'll comment on our performance using constant exchange rates or CR unless stated otherwise. Please turn to slide three. Today's call will last approximately one hour, with the presentation taking around 35 minutes and the remaining time for your questions. Today, our speakers are Emma Walmsley, Tony Wood, Luke Miles, Deborah Waterhouse and Julie Brown, with David Redfern joining for Q&A. Please ask one to two questions so that everyone has a chance to participate. Turning to slide four, I will now hand the call over to Emma.

Welcome to everyone joining us today. Please turn to the next slide. I am delighted to report that GSK's momentum this year continues with excellent second quarter performance. Sales grew 13% to 7.9 billion pounds, core operating profit was up 21% to two and a half billion pounds, and core earnings per share rose 17% to 43.4 pence, all excluding COVID solutions. This reflects our continued focus on operational execution and the strength of GSK's broad portfolio to prevent and treat disease. Sales growth was reported across all three product areas for the first half. For the second quarter, vaccine growth was driven by international expansion. Specialty medicines in particular were up strongly, growing over 20%, reflecting successful new launches of Jara in myelofibrosis, Gemperli in endometrial cancer, and long-acting HIV treatments. and we also delivered a record quarter for Trilogy in general medicines. All of this demonstrates the strength and breadth of our portfolio to deliver competitive and profitable long-term growth. This strong sales performance has been underpinned by effective cost control, driving operating leverage and further margin improvements this year. And these benefits are also delivering improved operational cash flow, providing funds for pipeline investment, as well as returns to shareholders. Our dividend for the quarter was 15 pence. And on the basis of our current performance and prospects, we are again upgrading our full year guidance. Next slide, please. We continue to invest in the pipeline and are making good progress. This quarter, GSK's longstanding expertise and leadership in respiratory will once again reinforce with positive phase three data reported for Depimocumab. In oncology, we continue to progress material growth opportunities, most notably the presentation of positive second line combination data for Blenrep to treat multiple myeloma. In vaccines, EREXV was first again with the approval by the FDA to prevent RSV disease in adults aged 50 to 59 who are at increased risk. Although ACIP's postponed vote on recommendation for this cohort was surprising, we have to remember this is a brand new vaccine. We look forward to sharing the additional data requested and more, and remain very confident that the benefit Erexi can offer to this age group, like other cohorts, will be fully recognised and that this best-in-class vaccine will reach its full sales potential. I'm also delighted that we've taken steps forward in clinical development for our pioneering ultra-long-acting HIV medicines, our potential functional cure treatment for Hep B, and our novel antibiotic, Gepatidazole. Next slide, please. Building trust by delivering across the six key areas we've prioritised for ESG remains a clear priority for all of us at GSK. Earlier this month, In partnership with Medicines for Malaria Venture, we launched Afeniquin in Thailand and Brazil. This is the first single dose radical cure medicine to prevent malaria relapse, another step forward to eliminating this disease. In May, we became a founding partner of the Fleming Initiative, a new global network that brings together scientists, policymakers and the public to fight antimicrobial resistance. And we've also started a phase three trial for a low carbon version of our metered dose inhaler, Ventolin. Using a next generation propellant, our new inhaler has the potential to reduce emissions by around 90%, versus the current one, and benefit millions of people with asthma. Please turn to slide eight. So I am delighted with GSK's continued progress and strengthening prospects. But before reminding you of these, a quick word on Zantac, given the ruling we had on admissibility of evidence this quarter. This Dalbert ruling in Delaware does not determine liability, and our position remains unchanged. We will continue to defend against the claims being made, and our aim, as it has been all along, is to manage this in the best interest of the company and shareholders, and to stay focused on our delivery. As many of you know, we started this year by setting out new, upgraded long-term commitments. And we're all focused on delivering against all of these, short, medium, and long-term. With our current momentum and the continued progress we're making, we have today upgraded our outlook for 2024, demonstrating the strength and in-depth and breadth of our portfolio. We now expect to deliver sales growth of 79% and core operating profit growth of 11% to 13%, with a short-term shift in this that the team will comment on. For 2026, we continue to expect more than 7% sales growth and more than 11% core operating profit growth on a five-year CAGR basis. And for 2031, we continue to expect sales of more than £38 billion with a broadly stable margin through the loss of exclusivity of Dolotegravir. And remember, these outlooks do not yet include the launch of Blenrat or ongoing progress in our early stage pipeline. So I'm now going to hand over to Tony to talk you through our R&D progress in more detail.

Thank you, Emma, and welcome, everybody. Next slide, please. As you know, our approach in R&D is to invest for growth in new best in class vaccines and medicines, combining our scientific focus on the immune system with the use of advanced technologies. Today, our pipeline comprises 70 assets in clinical development, and my priority remains the acceleration of the delivery of new vaccines and medicines for patients and to drive future growth for GSK. In the past six months, we secured regulatory approvals or received acceptance of submissions for 10 major medicines and vaccines and reported positive data from seven phase three studies. clearly demonstrating the innovation and health impact that GSK is now bringing to patients. Focused business development has continued as well. We strengthened our respiratory pipeline with the acquisition of Aeolus Bio for their long-acting T-slip antibody anticipated to start Phase 2 in 2025, and we gained full control of our candidate mRNA vaccines by restructuring our collaboration with CureVac. accompanying these were investments in two new technology platforms the acquisition of lc biotechnologies which will help accelerate our oligonucleotide program and an agreement with okra bio that will create foundational liver biology data sets deepening our understanding of disease and improving target identification in all we've advanced the pipeline across all our core therapeutic areas And importantly, we're on track with the development of the 12 scale product opportunities as well as Blenrep that we highlighted at the start of the year. These all have the potential to deliver profitable growth in the 2026 to 31 timeframe and to support our 2031 ambition of more than £38 billion in sales. I'll now take a closer look at a few important areas. Next slide, please. First in vaccines. where preventing seasonal viral and high-risk bacterial diseases remains a key focus for us. We have an extensive development plan for OREXV and continue to see this exceptional vaccine as a major long-term growth opportunity. OREXV is the world's first RSV vaccine and has demonstrated outstanding efficacy in adults of various ages. including more than 94% during the first season for people with comorbidities and who are at increased risk of severe RSV disease. In June, ACIP recommended use of EREXI for all adults aged 75 and over, and for adults aged 60 to 74 who are at increased risk from severe RSV disease. The committee unexpectedly postponed a vote in adults aged 50 to 59, requesting additional data. These include evidence from vaccine surveillance databases to further support the benefit-risk profile observed during clinical trials in a real-world setting. We look forward to contributing to these data over the coming months. I'm also looking forward to the data from studies 006 and 004 assessing efficacy, immunogenicity and safety of orexi over three RSV seasons. These data will be important to help answer some of the questions raised by ACIP on outcomes and duration of protection. As a reminder, Season 2 data showed 75% cumulative vaccine efficacy against severe lower respiratory tract disease over 23.3 months. These data support the strong and durable protection that this uniquely adjuvanted vaccine offers against RSV. Later this year, we're also looking forward to sharing more from trials in adults aged 18 to 49 who are at increased risk from RSV disease. Next slide, please. Next, a comment on the interesting data for Shingrix that we shared yesterday at the Alzheimer's Association International Conference in Philadelphia. These data add to the growing body of evidence exploring the observed association between shingles vaccination and a reduced risk of dementia. Our study was prompted by a number of observations, some of which are summarized on this slide. There's a growing body of evidence largely generated from retrospective case studies in very large populations that herpes zoster vaccination is associated with a reduction in the diagnosis or onset of dementia. These data include a recent observational study in Wales which concluded that vaccination with a live attenuated herpes zoster vaccine was associated with a 20% reduction in dementia diagnosis when compared to people who did not receive the vaccine. Using an AIML approach and data from Optum's electronic health record dataset, we constructed a retrospective observational study comparing matched cohorts of adults vaccinated with Shingrix, a competitor live attenuated shingles vaccine, and a comparator pneumococcal vaccine. Headline data shown on the right-hand side of this slide suggests that after three years, Shingrix was associated with a 27% reduced risk of acquiring dementia when compared with the competitor zoster vaccination, and a 24% reduced risk of dementia when compared to the comparator pneumococcal vaccine. The potential relationship between shingles prevention and risk of neurodegeneration is an area of increasing interest for the scientific community. These are interesting early results, which we are investigating with additional retrospective and mechanistic studies. Next slide, please. Turning now to respiratory. We're making good progress with novel treatments that could provide more effective options for severe asthma, COPD, and refractory chronic cough. Depimocumab is the first ultra-long-acting biologic engineered to have high affinity for IL-5. It enables sustained inhibition of type 2 inflammation with twice the early dosing versus current options, some of which require injections every two weeks. This quarter, we announced that two pivotal phase three trials in severe asthma with an eosinophilic phenotype, Zwift 1 and Zwift 2, met their primary endpoints, demonstrating that two doses of Depamocumab administered over a 12-month period showed a statistically significant and clinically meaningful reduction in significant exacerbations versus placebo in combination with standard of care. We're looking forward to sharing full data at the ERS conference in September, and we remain on track to file the medicine for approval later this year. Depomocumab's development program is being informed by predictive biomarkers and phenotyping, which has enabled us to progress four clinical indications in parallel. The pivotal ANCA1 and 2 trials in one of these, chronic rhinosinusitis with nasal polyps, are now closed for recruitment with data expected later this year. We also expect to see phase three data on the use of Nicala and COPD this year and phase three data for Camlipixent in the treatment of refractory chronic cough in 2025. Next slide, please. You'll shortly hear from Deborah on the important advances in our HIV pipeline. So I'll conclude with a brief summary of the strong progress we've made within the oncology portfolio during the first half. We're building an emerging and high potential portfolio of new medicines. with a growing focus on ADCs, immuno-oncology, and targeted small molecules. For Blenrep, pivotal data from the DREAM-7 and DREAM-8 studies presented at ASCO demonstrate the potential for Blenrep to become the new standard of care for patients with multiple myeloma in the second-line setting. These trials will serve as the basis for regulatory submissions, and we're pleased that EMA recently accepted our first filing for this indication. Additional filings are planned before the end of the year. Also stated the recent mid-management event, we plan to start a phase three trial in the first-line setting in early 2025. For GemPurlie, recent data from the RUBI trial demonstrate a statistically significant overall survival benefit in an all-comer population with primary advanced or recurrent endometrial cancer. GemPurlie is the only immune oncology agent to demonstrate a survival benefit in this patient population. These data have been filed with the FDA and we anticipate a response ahead of the 23rd of August PDUFA date. Carefully targeted Phase 3 trials investigating the use of Gemperli in the treatment of rectal, lung, and head and neck cancers are also ongoing. The first half of 2024 also saw a number of oncology indication trial starts, including GALAXYS301, a Phase 3 trial investigating our TIDGET antibody, Belarustatog, in combination with Gemperli in the treatment of first-line PD-L1 high non-small cell lung cancer. the Gliofocus phase 3 study, which will investigate Zejula in the treatment of newly diagnosed glioblastoma, and a phase 1 study of our B7H4ADC, JSK584, which recently entered the clinic. We're looking forward to seeing more data from our ADCs by the end of the year to inform pathways for accelerated registrations. Finally, we're pleased to announce the recent Japanese approval of Omjara with a line agnostic label for all patients with myelofibrosis. So in summary, a productive first six months to 2024. I'm pleased with the progress we're making to deliver differentiated health impact for people and patients. And I'll now hand over to Luke.