GSK plc

This is the usual state and arbor statements. We will comment on our performance using constant exchange rates or CR unless stated otherwise. As a reminder following the consumer healthcare demerger in 2022 to form Halian, we're presenting performance and growth of the continuing operations for GSK. Please turn to slide three. Today's management presentation will last approximately 30 minutes with the remaining 30 minutes for your questions. For those who wish to ask questions please join the queue by raising your hand, press star nine to raise and lower your hand if you're on the phone and we request that you ask one to two questions so that everyone has a chance to participate. Our speakers are Emma Walmsley, Tony Wood, Liz Miles, Debra Waterhouse and Iman Khai with David Redfern joining the rest of the team for Q&A as we hit the end of the call. Julie Brown who will officially start as CFO next week is also with us today on the call in a listening capacity only as part of the CFO succession handover. Turning to slide four and I'll hand the call over to Emma.

Thanks Nick and welcome to everybody. Please turn to the next slide. Our purpose is clear to get ahead of disease together by uniting science, technology and talent. We are preventing and treating disease at enormous scale and delivering a new chapter of growth. As a world leader in infectious diseases we are also focused on building our business in HIV, immunology, respiratory and oncology and we're off to a strong start in 2023 showing our strategy continues to deliver for all stakeholders. Excluding pandemic solutions we've delivered double digit sales growth including a fifth consecutive quarter of growth across the full portfolio with excellent commercial performances in vaccines, specialty and general medicines. Our adjusted operating profit excluding COVID-19 solutions also grew by five percent. Below the rate of sales growth this quarter due to some one-off factors as well as planned investment in new launches and Ian will cover this in a moment. Our adjusted EPS grew by 14 percent and we're firmly on track for our guidance this year. Our clear capital allocation priorities mean we continue to invest for growth and to deliver shareholder returns and the board approved a dividend of 14 pence for the quarter. Please turn to slide six. Our continued commercial success comes with a focus on driving the performance of our key growth products contributing a new record 44 percent of our Q1 sales adding 500 million pounds of additional revenue versus Q1 of last year. Notable contributions came from Shingrix and our HIV 2 drug regiments. Our growth drivers and new launches will support our growth over the decade and beyond. Our business mix continues to shift the vaccines and specialty medicines which are now delivering more than 60 percent of sales and we're confident this shift will progress to around three quarters of our revenue by 2026. A large portion of the growth is due to our pipeline launches in recent years. New products launched since 2017 delivered 2.2 billion pounds during Q1 alone underpinning our confidence in continuous future investment in pipeline development. Please turn to slide seven. Our R&D progress is delivering on our priority to strengthen our long-term growth prospects. In infectious diseases we're advancing our RSV older adult vaccine through the regulatory process and are on track to get the first US FDA approval in May and we also reported positive data last month on our pentathalent men ABCWY vaccine adolescents. We continue to invest in our priority vaccines platforms including protein-based antigens, mRNA following some encouraging early data in flu this year and bacterial platforms like MAPS. In HIV we presented positive data on long-acting cabanouche compared to a daily oral medicine and we continue to enhance our portfolio with business development. In March we signed an exclusive license agreement with Sinexus to access a -in-class novel antifungal adding to our growing anti-infectives portfolio and we're also delighted to announce the proposed acquisition of Bellis Health last week further strengthening our specialty medicines and building on our respiratory expertise with the potential best in class treatment for refractory chronic cough. We expect to do more targeted business development in the year ahead. Tony and the team look forward to sharing updates on our continued pipeline development and progress throughout the year with a series of therapeutic area focused meet the I'll now hand it over to him for some more pipeline details.

Thank you, Emma. Please turn to slide nine. Our R&D strategy is focused across four therapeutic areas shaped by our world-leading capabilities in infectious diseases, our understanding of the immune system and our technology capabilities. Our pipeline today comprises 68 assets in clinical development around two-thirds of which target infectious disease and HIV and we're making good progress in continuing to strengthen our growth prospects for 2026 and beyond. This quarter we saw two US FDA approvals, two advisory committees and several assets progress through clinical development including a phase two start for our oligonucleotide NASH asset GSK 990. We also started recruiting into our phase three program for BIPI-reversive for the treatment of chronic hepatitis B. Our ambition for BIPI is to improve functional cure rates for chronic hepatitis B patients and establish a new standard of care. We look forward to presenting data from the phase three B2GETA trial in the second half of this year. Next slide, please. Elsewhere in our infectious diseases portfolio we reported three important developments in the quarter. Firstly we received a positive recommendation from the FDA's advisory committee for our RSD vaccine OREXV. We remain on track for an FDA decision anticipated by May 3rd. Our phase three RSD study re-randomized subjects for a second season to receive either vaccine or placebo. These second season data will be important to better understand the duration of protection provided by OREXV. Data collection is ongoing and we expect a study report around the year. Secondly we announced positive data from our MEN-ABCWY phase three trial which demonstrated that our pentavalent vaccine has comparable protection to Bexarro and Menveo, was well tolerated with a safety profile consistent with Bexarro and Menveo. Invasive meningococcal disease is an uncommon but serious infection which can cause life threatening complications and death. Five serogroups are responsible for most meningococcal infections and there is currently no single approved vaccine which can protect against all five of these groups. Our pentavalent vaccine combines the antigenic components of Bexarro and Menveo. It's approved it could provide the broadest meningococcal serogroup coverage of the class and a simplified immune immunization schedule which we expect will lead to increased vaccine uptake. We will present preliminary data from this phase three trial at ESFID in May. We look forward to sharing these data with regulators to make this important vaccine innovation available as soon as possible. Finally at ECMID we presented positive phase three data for Jeppie-Tydison in the treatment of uncomplicated urinary tract infections. In the US alone there are around 15 million UTI episodes each year, around a quarter of which are resistant to existing treatments. Jeppie-Tydison has the potential to become the first new class of antibiotics for uncomplicated urinary tract infection for over 20 years. To complement Jeppie-Tydison we've also been active in business development. At the end of last year we added Tebupen, a novel antibiotic in phase three for complicated urinary tract infection to our infectious diseases portfolio. Also in March we agreed to in-license Brexifem, a novel oral cancer synthase inhibitor approved for treating vulvavaginal candidiasis. Together these three novel agents will broaden our anti-infective portfolio, an area of significant societal need. In HIV we reported data from SOLAR, the first -to-head study of our long acting HIV treatment cabanuvra versus a daily oral therapy. SOLAR demonstrated non-inferior efficacy, a very low virologic failure and a strong patient preference for cabanuvra, with 90% of participants in the trial expressing a preference for the long acting regime. At CROI we also present proof of concept data from N6LS, our broadly neutralizing HIV antibody. These data demonstrate high potency from a single antibody even at the lowest dose tested. Our neutralizing antibody is just one of the most important components of our treatment. We also have a very high potential for a combination of the two. We are very happy to announce that we are currently in development as a potential combination partner for Cabotegravir. Next slide please. To augment our respiratory and specialty franchises we're delighted with our recent agreement to acquire Bellis Health, a late-stage biopharma company working to better lives of patients suffering from refractory chronic cough or RCC. When completed the acquisition will provide GSK access to Camelopixant, a potential -in-class and highly selective P2X3 antagonist currently in phase 3 development for the first line treatment of adult patients with RCC. RCC affects around 28 million people globally and is defined as a persistent cough lasting for more than eight weeks that does not respond to treatment for an underlying condition. There are no approved medicines for RCC which has a significant impact on quality of life with some patients experiencing over 900 coughs each day. Camelopixant has the highest P2X3 selectivity in the class. Phase 2 reported a very low incidence of dyscusea, a taste disturbance attributed to P2X3 selectivity that frequently leads to patients discontinuing treatment. Phase 3 trials are underway and are expected to read out by 2025. We're confident that the phase 3 program will confirm a -in-class profile and provide an excellent addition to our specialty medicines portfolio building upon our expertise in respiratory therapies. Next slide please. In oncology we were pleased to report two significant developments adding to the support to STALAMAT. The Ruby trial presented at SGO and ESMO meetings in March demonstrated a 72% reduction in the risk of disease progression or death in the DMML population of patients with first line advanced endometrial cancer. In the overall population preliminary overall survival data showed a clinically meaningful trend and a 36% reduction in risk of death or progression in favor of the STALAMAT treatment. Endometrial cancer remains a significant unmet medical need. Over 400,000 new cases are reported annually with around 15 to 20 percent of patients presenting with advanced disease at the time of first diagnosis. We look forward to sharing these data with regulators as soon as possible. In February a US FDA advisory committee voted to support our proposed trial design to evaluate Jim Purley in treating locally advanced rectal cancer. The trial is now recruiting patients. Next slide please. As pipeline momentum continues to build in vaccines, HIV and infectious diseases this slide highlights important regulatory events and clinical data readouts anticipated in the next 12 months. A more comprehensive view of the portfolio is provided in the appendix. We anticipate an FDA decision for RxV or RSV older adult vaccine in early May with additional data to support the vaccine launch including those from a high risk 50 to 59 year old co-old additional flu combinations and second season outcomes. In oncology we anticipate an FDA decision for more melatonin in the treatment of myelofibrosis in June. We also anticipate presenting our data from the Bee Together Phase 2 trial which will provide evidence on the durability of response for hepatitis B patients receiving VEPI and interferon. Part of our program to develop a functional cure for some of the 300 million people living with chronic hepatitis B infection today. The continuous progress we are making underpins my confidence that our pipeline will drive growth in the latter half of the decade. Recent data, pipeline progression and business development have further strengthened our R&D portfolio and I look forward to sharing more data with you over the coming quarters and in future meetings. I'll now hand over to Luke on slide 15.