GSK plc

and gentlemen, a very warm welcome to this GSK Q1 2025 results call. My name is Konstantin Fest, new head of IR at GSK, and I'm delighted to be joined today by Emma Warmsley, Luke Miles, and Julie Brown. I'm pleased to say Deborah Waterhouse, CEO of Veev, returned this week full-time, but David Redfern, chairman of Veev, will be covering HIV today. Tony Wood, our CSO, will also be joining us for Q&A. Today's call will last approximately one hour, with the presentation taking around 30 minutes and the remaining time for your questions. Please ask only one to two questions so that everyone has a chance to participate. Before we start, please turn to slide 3. This is the usual safe harbor statement. We will comment on our performance using constant exchange rates, or CER, unless otherwise stated. I will now hand over to Emma on slide 4.

Thank you, Konstantin, and it's great to have you on board. And welcome to everybody joining us today. Please turn to the next slide. GSK continues to make strong progress. Group sales were up 4% this quarter, core operating profit grew 5%, and core earnings per share also rose 5% to 44.9 pence. This performance was in line with our expectations and again demonstrates the quality, strength, and resilience of GSK's portfolio. Sales growth was driven by Specialty Medicines, our largest business, up 17%, with strong contributions from respiratory, immunology, and inflammation, oncology, and from HIV. As expected, vaccine sales were down 6% and general medicine sales were broadly stable. R&D delivery has continued, with two out of the five FDA product approvals we expect in 2025 now secured, and we completed the acquisition of IDRX, which adds another very promising oncology asset to our pipeline. Cash generated from operations was over £1 billion, providing further funds to invest in growth and to deliver returns to shareholders. Our dividend for the quarter increased to 16 pence, and we've commenced the £2 billion share buyback programme announced in February. Alongside this, we are proud to have sustained progress with our trust goals and estimate that in the last four years GSK has reached at least 2 billion people with our vaccines and medicines, including through our global health work. Finally, we're confirming the financial guidance previously given for 2025. Next slide, please. We continue to make good progress on delivering R&D productivity improvements and future growth opportunities. As we said at the full year, R&D is very focused on delivering the potential of 14 key pipeline opportunities, all of which are expected to launch between 2025 and 2031, and all of which have peak year sales potential of more than £2 billion. This portfolio demonstrates the strategic shift we've made to develop more specialty medicines, many of which offer long acting preventative type care and better adherence for patients. Along with the recent approvals for Penmenvi and Blue Jepa, we continue to expect FDA approvals for Nucala COPD imminently, Blen Rep in July and Depimokima by the end of the year. Innovation in our pipeline also continues to be recognised. Next, we received another breakthrough designation for our novel ADC targeting B7H3, and we look forward to sharing more data from our ADC programmes later this year. This quarter, we also presented data from our high potential HIV injectable portfolio at CROI, including positive data from our third generation INSTY, which advances our leadership position in the development of long acting agents to treat as well as prevent HIV infection. Our number one priority for investment remains growth through innovation, organically in R&D and with continued targeted business development. And we're specifically prioritising investment to key assets in RINI and oncology, alongside long acting HIV and core vaccine opportunities. On a broader investment front, we were also very pleased to break ground on our new state of the art manufacturing facility in Marietta, Pennsylvania this quarter. This is squarely targeted on increasing manufacturing capacity for new pipeline products in the US and means that GSK will have six manufacturing sites in America. Next slide, please. We remain highly confident in our commitments to growth. Whilst there are clearly elevated levels of uncertainty in the macro environment right now, including from possible sector tariffs, we start from a position of strength. Our momentum, together with the strength of our portfolio, the resilience we've built into our supply chain, and our proven capability to drive operating leverage, mean we have the ability and options to navigate and mitigate this. This underscores our confidence that 2025 will be another year of profitable growth and why we remain on track to deliver our guidance and our outlooks. With that, I'll hand over to Luke.

Thanks Emma. Please change to the next slide. In Q1, we delivered 7.5 billion pounds of sales, up 4% versus last year, demonstrating the resilience of our diverse medicines and vaccines portfolio. As Emma mentioned, growth in the quarter was driven by specialty medicines, which continued to more than offset anticipated headwinds in our vaccines business. By region, growth was driven by Europe up 11%, with the US up 4%, impacted by a challenging comparator base and the introduction of the IRA, which is previously stated we anticipate to be a 400 to 500 million pound headwind throughout the year. Next slide, please. Specialty medicines continued its excellent momentum, growing 17% in Q1, with strong performances across all therapy areas. In addition, three of the five product approvals we expect this year are in specialty medicines. That's BlendRep, Nucala and COPD and Depil MicroMod, and I'll talk about them shortly. R&I was up 28% in the quarter, and within that, Benlister, our treatment for lupus, grew 39%, and Nucala, our anti-IL5 biologic treatment, grew 21%. With both of these benefiting from strong demand, as well as the comparator, which saw US channel inventory reductions in Q1 last year, a bettas of which will not repeat in the remainder of the year. In oncology, Q1 sales were up 53%, with sales of gemperley and ojarra more than doubling. Gemperley, the only -oncology-based treatment to show an overall survival benefit in endometrial cancer, continues to see increased patient uptake in the US and Europe, following all countries' approval for primary and advanced or recurrent endometrial cancer. And ojarra sales were driven by high US volumes and strong uptake following the new market launches in Europe and international. And this market expansion continued in Q1, with launches in Spain and Italy. We expect very strong momentum in our specialty medicines portfolio to continue and reconfirm our 2025 sales guidance of the low double-digit percent increase. Next slide, please. Innovation is our priority, and we've got three exciting approvals expected in specialty medicines this year. BlendRap was approved in the UK earlier this month and has an FDA-ponufed date in July, with a projected overall survival benefit of 33 months in Dream 7 compared to standard of care, manageable safety profile, and low treatment burden. Feedback from physicians is that BlendRap could redefine second-line multiple-mild loan treatment. Dose interruption enabled and managed ocular side effects, and it's an immediate 30-minute infusion administered in a community setting, which is where severe disease patients are treated in the US. We're also being very thoughtful about the launch, which, as I've said in the past, will be staged. We'll work -in-hand with individual physicians and patients to ensure dose management is understood and the ophthalmic support network is in place. Laying this groundwork will help firmly establish BlendRap in the second-line multiple-mild loan market and demonstrate the benefits of this transformative medicine. Turning to respiratory, GSK has been a leader in the prevention and treatment of respiratory disease for more than five decades. In 2015, we launched Nucala for severe asthma, the first monoclonal antibody to target IL-5. Next week, we're expecting FDA approval for a major new indication to Nucala to treat COPD, the third leading cause of death worldwide, affecting more than 300 million people globally. We've got an experienced field force in place and are ready to launch. We expect to share the full phase three of the MATNA trial results very soon, including data on the reduction of most serious exacerbations, which lead to hospital presentations, which are known to be the strongest indicator of disease progression and death. Also in respiratory is Depamocomab, our exciting new -IL-5 medicine with six-month dosing, which has been filed in all major markets for approval in both severe asthma and chronic rhinocytosis with nasal polyps, with a US FDA decision expected towards the end of the year. In a pooled analysis of the swift pivotal studies in asthma with type two inflammation characterized by blood in centerfold count, Depamocomab demonstrated a 72% reduction in exacerbations requiring hospitalization and feedback from the asthma community on these data have been very positive. In a poll pulmonologist 86% think Depamocomab could become a new standard care and 82% said they would consider prescribing Depamocomab ahead of alternative biologics. So this is this is clearly a significant opportunity to increase the uptake in binary naive patients given rates and asthma remain low. We estimate that only around 21% of eligible asthma patients currently receive a biologic with patients potentially benefiting from increased adherence from a twice yearly dosing schedule. And we anticipate Depamocomab will also capture share from shorter acting alternatives. And this underpins our confidence in Depamocomab's multi-billion pound peak year sales potential. I'll now hand over to David to cover HIV.