GSK plc

Hello everyone, welcome to today's call and webcast. The presentation was sent to our distribution list by email and you can find it on gsk.com. Please turn to slide two. This is the usual safe harbour statements. We'll comment on our performance using constant exchange rates or CR unless stated otherwise. As a reminder, adjusted results are now referred to as core like many European pharmaceutical peers. Please turn to slide three. Today's call will last approximately one hour with the presentation taking around 25 minutes and the remaining time for your questions. Today our speakers are Emma Walmsley, Luke Miles, Deborah Waterhouse and Julie Brown. With Tony Ward and David Redfern joining for Q&A. Please ask one to two questions so that everyone has the chance to participate. Turning to slide four, I will now hand the call over to Emma.

Thanks Nick and welcome to everybody joining us today. I'm delighted to be presenting to you all with another set of excellent quarterly results for GSK. Please turn to the next slide. We have had a very strong start to the year. Sales and profits grew double digits for the quarter with sales up 13% to 7.4 billion pounds, core operating profits up 35% to 2.4 billion pounds and core earnings per share up 37% to 43.1 pence, all excluding COVID solutions. This excellent performance reflects our continued focus on execution, some benefit from phasing in the quarter and strong delivery of our recent launches. It also demonstrates the great momentum we continue to see across the business. Demand for our innovative vaccines and specialty medicines was clear with strong growth across new products. Our very good sales performance was also underpinned by good cost control. Julie will take you through the details on this in a moment but I particularly want to highlight our SG&A performance which was delivered alongside increasing investment in R&D, demonstrating continued delivery of effective operating leverage and margin improvement. These benefits are also delivering improved cashflow, providing funds for investment and returns to shareholders. Our dividend for the quarter was 15 pence. And for the full year, we are upgrading our guidance and looking forward to delivering another year of meaningful growth for shareholders. Next slide, please. Alongside our excellent financial performance, we've seen strong pipeline progress across the therapy areas with phase three data readouts for four medicines. For Jeopardycin, further pivotal data that supports regulatory submission of this new antibiotic. For Cabanuvra, further evidence of superior efficacy. For Gemperle, potential broader use of this medicine to treat endometrial cancer. And lastly, encouraging clinical data supporting use of Blenret for the treatment of multiple myeloma. These data will be presented at ASCO and we look forward to sharing more with you on our plans for oncology at our meet the management event in June. These readouts together with other R&D achievements this quarter mean we've strengthened growth prospects in all of our key therapeutic areas. Three material points I'd highlight. First, we continue to strengthen our innovative vaccine portfolio this quarter. With regulatory submission of our new five in one meningococcal vaccine candidate, alongside new expansion opportunities for both ArexV in the US and Shingrix in China. Second, positive clinical trial findings for an ultra long acting formulation of Cabotegravir, further supporting progression of this medicine and confidence in the important transition we expect in our HIV portfolio for long-term growth. And third, in respiratory, we completed the acquisition of Aeolus Bio, a signal of our continued investment and leadership in this disease area where our next important step will be sharing data for Depimocomap, which we expect in Q2. Next slide please. Alongside delivering stronger shareholder returns, we continue to build trust by delivering across the six key areas we prioritise for ESG. This quarter we published our ESG performance report. 95% of the metrics we target are being met or exceeded. We also saw the GSK developed TB vaccine candidate enter phase three, sponsored by the Gates MRI and Wellcome Foundation. This could potentially be the first new TB vaccine in over a hundred years. So all in a very good start to the year. Let's now hear more from the team on our progress, starting with Luke.

Thanks Emma, please turn to the next slide. In Q1, we delivered growth across all our product areas and regions with 7.4 billion of sales, up 13% versus last year, excluding COVID solutions. This includes a strong performance in the US, led by continued contributions from our new launch products. Please turn to slide 10. In vaccines, we saw strong growth of 22% in Q1, excluding COVID solutions, led by OREXF and Shingrix. Following the outstanding launch last year, OREXF continued to deliver with sales of 182 million pounds in the quarter. Script data shows a strong preference for OREXF as we received two out of every three retail prescriptions, with US market penetration of around 14%. I'll cover OREXF in more detail on the next slide. Shingrix delivered a record of 945 million pounds in the quarter and was up 18%, driven by public funding outside the US, together with early supply to our new partner, Xifei in China. Outside the US, Shingrix has launched in 39 markets and the majority have less than 5% penetration. In the US, sales decreased by 4%, reflecting the comparison to Q1-23, which benefited from the removal of the co-pay for adults aged 65 and over on Medicare, as well as the prioritisation of other adult vaccines during the bio-respiratory season. We are investing in DTC and ACP campaigns as we seek to activate -to-reach consumers to continue to grow the cumulative immunisation rate, now at 37% of people aged 50 and older, which leaves more than 75 million Americans still unvaccinated and eligible to receive Shingrix. Our expectation continues to be that Shingrix sales will reach more than 4 billion pounds over time, driven by growth outside the US. In addition, we have also recently shared exceptional data demonstrating vaccine efficacy of 82% at year 11. Turning to our meningitis portfolio, Bexera and Menvo sales were up 3% and 41%, respectively in the quarter, with performance in Brazil and favourable phasing driving the growth in Menveo. We're pleased to have received FDA file acceptance for our MenABCWY vaccine in mid-April, and combined, our meningitis portfolio is expected to deliver around 2 billion pounds in peak year sales. Across our vaccine portfolio, we expect sales to increase high single to low double-digit percent in 2024. Next slide, please. Focusing on RSV, we vaccinated over 1.3 million people with Ravexvi in the retail setting during Q1. The launch was exceptional and exceeded our expectations. We now see seasonality similar to flu, impacting use patterns in the first year. In 2024, we expect the vast majority of sales to be in the US, and weighted to the second half in preparation for the 2024-2025 RSV season. This year, we continue to build on our competitive profile with the potential to expand the label, adding at-risk individuals in the 50-59 cohort, which could impact approximately 15 million people in the US. This is subject to approval, followed by ASIP review in June. Last year, we presented data supporting an efficacy profile for Ravexvi of at least two seasons. As the 23-24 RSV season is coming to an end, later this year, we expect to have additional efficacy data on long-term duration of protection and immunogenicity data over three years. We plan to present the totality of data at a future public health forum in the second half of this year, and we do not expect public health officials to decide on the frequency of RSV vaccination or revaccination before 2025. We're ambitious about growth in an expanding market with increasing competition. Whether a two-season or a three-season vaccine profile, we remain very confident that OREXI can achieve more than 3 billion in PQS sales over time. Next slide, please. In specialty medicines, including HIV, which Deborah will cover shortly, we increased sales by 19% excluding COVID solutions. In respiratory and immunology, our market-leading medicines, Nucarla and Benelist are continuing to deliver good growth. Nucarla was up 13% reflecting high patient demand for treatments addressing severe eosinophilic asthma, chronic rhinocytosis with nasal polyps, and EGPA. Our Matinee trial to confirm the efficacy of Nucarla in COPD is expected to read out in the second half of this year. We also expect pivotal trial results for our six-monthly IL-5 Depamocomap. This year with readouts in aspirin Q2 and chronic rhinocytosis with nasal polyps before year-end. Combined, we anticipate our IL-5 portfolio to deliver more than 4 billion pounds in PQS sales. Benelist continues to show consistent growth and was up 8% in the quarter with opportunities to drive earlier intervention and increase penetration in both SLE and lupus nephritis. In oncology, sales more than doubled in the quarter. Omgara has continued to perform well following last year's launch, and I'll talk more about this on the next slide. We're pleased to receive authorization from the European Commission for Omgara in late January, and we've since launched in the UK and Germany. GenPirle has also continued to grow strongly, and again, I'll discuss this further on the next slide. Zidula's performance was driven by increased patient demand and higher volumes due to the new tablet formulation with further growth from new international launches. Overall, we expect strong performance for our specialty medicines in 2024 with growth of low double-digit percent. Please turn to slide 13. Omgara, which we acquired from Sierra Oncology, has performed exceptionally well following last year's launch and has the strongest uptake curve for a JAK inhibitor in myeloproporosis. Omgara is establishing market share in both the first-line and second-line settings, and we've seen encouraging data suggesting physicians are anticipating increasing their use of Omgara in the coming months. For GenPirle, we've demonstrated strong execution in the quarter with our new patient share up 33%, and we continue to build further clinical evidence in endometrial cancer, where we recently presented data demonstrating that GenPirle plus chemotherapy is the only IO combination to show statistically significant and clinically meaningful OS data in the all-comers population. Subsequently, the FDA has granted a priority review to our file to expand the treatment with GenPirle to all adult patients with primary, advanced, or recurring endometrial cancer. We also expect this data to be published soon in a peer-reviewed journal. On BlendRep, we're encouraged by the data from DREAM7, which showed a tripling of progression-free survival. DREAM8 also met its primary endpoint and showed a statistically significant and clinically meaningful PFS compared to standard of care in second-line multiple myeloma. In addition, DREAM7 and 8 also demonstrated strong overall survival trends, and we will continue to follow up to completion. We look forward to presenting these data at ASCO in June and are targeting regulatory filings in the second half of the year. Next slide, please. Finally, turning to our general medicines portfolio, we're looking at the impact of the COVID-19 pandemic The US sales grew 1% in the quarter, led by Trilogy delivering 591 million pounds and established products in emerging markets. We've also seen growth owing to stockpiling and patient demand, and it's still early in the year, and we are continuing to assess and manage the impact of the AmCap removal in the US. And as a reminder, there was 150 million US dollar impact in 2023, and we continue to expect up to 550 million US dollars of sales at risk for the full year. The growth outlook for GenMeds is unchanged. I'll now hand over to Deborah to cover HIV.