GSK plc

Ladies and gentlemen, a very warm welcome to the GSK Q2 2025 results call. I'm delighted to be joined today by Emma Wormsley, Tony Wood, Luke Miles, Deborah Waterhouse and Julie Brown, with David Redfern joining 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 three. This is the usual safe harbour statement. We will comment on our performance using constant exchange rates or CR, unless otherwise stated. I will now hand over to Emma on slide four.

Thank you and welcome to everybody joining us today. Please turn to the next slide. Our second quarter results once again demonstrate GSK's strong performance momentum and the quality and strength of our portfolio. Group sales were up 6% for the quarter, core operating profit was up 12% and core earnings per share grew 15% to 46.5 pence. Sales growth was driven by our largest business, Specialty Medicines, up 15% and vaccine sales also contributed with sales up 9% in the quarter. This led to increases in profits and earnings, which also benefited from a strong focus on SG&A. Alongside operating performance, we continue to make good progress in R&D, with three FDA approvals achieved so far this year. Cash generation also remains very positive with £3.7 billion generated in the first half to support further investments in growth and returns to shareholders. The dividend for the quarter was 16 pence and we've now completed more than £800 million of the share buyback programme initiated in February. All of this is underscored by our commitment to operating as a responsible business. Our most recent action being to expand our voluntary licence agreement with the Medicines Patent Pool to now include long acting cabotegravir for treatment of HIV as well as prevention. And finally, driven by our strong performance, we're confirming today that we now expect to be towards the top end of the financial guidance given for 2025. Next slide please. Following the de-merger of Halion, we made a commitment to drive a step change in performance at GSK. This quarter has again shown that GSK is delivering consistent sales growth, operating leverage and positive financial performance. The investments and development choices we made in our portfolio, notably to launch new specialty medicines, have really helped to drive these new performance levels. In the last three years, we've launched innovations in respiratory, immunology, oncology and HIV and we have a lot more to come. Alongside our new vaccine to prevent meningitis and an antibiotic to treat urinary tract infections, three of the five product approvals we expect this year are specialty medicines. Tony will talk to each of them in more detail shortly. But let me touch just briefly on BlenRep. As you'll have seen, the FDA has extended the review period for BlenRep with a new target action date of the 23rd of October. We remain very confident that BlenRep can bring significant benefits to patients with multiple myeloma in the US and are in constructive discussions with the agency. Meanwhile, we continue to receive approvals and prepare for launches of BlenRep in many other countries, including across Europe, Japan, Canada, the UK and Switzerland. So with the portfolio we have and the launches to come, we expect specialty to be a major driver of growth for GSK. Our specialty business accounts for around 40% of sales today, and we expect this to be well over 50% by 2031. Next slide, please. As we've consistently said and demonstrated, our number one priority for capital allocation is to invest for growth. We're doing this by focusing strongly on the delivery of the 14 scale opportunities we've previously highlighted, all of them with peak year sales above £2 billion. By ensuring we have appropriate resources for priority launches and by prioritizing capital in R&D to RINI and oncology, both organically and with targeted business development. Our BD has real momentum and is a key driver of pipeline expansion. We'll be adding four high potential assets to late stage development this year, and three starting Phase 3 were sourced through Discipline BD, IDRX, MS for Spermin and our ADC targeting B7H3. We'll also begin a pivotal trial to support our four monthly long acting injectable regimen for HIV treatment. And we continue to add high value innovation at earlier stages of development too. The pioneering strategic collaboration announced with Hangrui this week is another excellent example of this. Lastly, and very importantly, we continue to optimize our supply chain with significant investment in US manufacturing and scaling up of capacity for our new modalities and technology platforms. And as we said last quarter, our overall planned investment in the USA is in the tens of billions of dollars over the next five years. Next slide, please. With the breadth of our current business and the growth opportunities we have in our pipeline, we are highly confident in our outlook for sales of more than £40 billion by 2031. And as we've repeatedly demonstrated with our pipeline development, this long term outlook has consistently improved and we are ambitious and committed to do more. Next slide, please. So overall, with the momentum we have and the progress we're making, we're very confident we can deliver the targets we've set for growth in the short, medium and longer term. Let me now hand over to Tony to talk to you in more depth about our great R&D progress. Next slide,

please. Thank you, Emma. Next slide, please. Our number one priority in R&D is to develop transformational specialty medicines and vaccines in areas of high unmet need that positively impact health and deliver significant growth. This is evident in the 14 scale opportunities we have for launched before 2031 and in the progress we're making to expand and accelerate our early stage pipeline of first and best in class assets. We remain focused on four core therapy areas enabled by advanced technologies, talent and a network of world class partnerships. And we continue to deepen our expertise in the science of the immune system. This is most recently exemplified with our work to develop IL-5 medicines for lung diseases, which is providing us with a better understanding of the role of the immune system in fibroinflammation, leading us to target diseases beyond the lung towards kidney, liver and with the potential future application in neuroimmunology. Next slide, please. Based on decades of research, we have a unique understanding of the role that inflammation plays in chronic airway disease. Our focus on the underlying biology of inflammation, notably in COPD, has led to a differentiated pipeline of long acting options, each strongly supported by human genetics, disease phenotyping and insights from our own scaled clinical trials. In May, we received FDA approval from Newcala for the treatment of COPD. This is the fifth indication for Newcala in the US. We've also filed Depamocomab, our novel ultra long acting IL-5 antagonist for the treatment of asthma and chronic rhinocynositis with nasal polyps with regulators. And we have a PEDUFA date of 16 December. I'm also pleased to report for the first time today positive results from the Agile Continuation Study, which further underscore the sustained efficacy and safety over a two year period of twice yearly Depamocomab. Agile is an open label 12 month extension study into the Erasmus patients who completed either SWIFT1 or SWIFT2. The results show that patients who continue to receive Depamocomab maintain the efficacy achieved in the prior trials. Importantly, patients who crossed over from placebo also saw reduction in exacerbation rates consistent with results in SWIFT. As a reminder, the SWIFT studies demonstrated a 72% reduction in exacerbations requiring hospitalisation for patients who received Depi. I'm also pleased to confirm today that we've started an extensive development programme for Depi as an add-on treatment in COPD. The Endura trials are now recruiting and the Vigilant trial, designed to evaluate efficacy in earlier stage disease, is planned to start later this year. As the only company with a range of ultra long acting mechanisms, specifically IL-5, IL-33 and T-slip, we're competitively placed to lead in this disease. And through our license agreement with Hungary, we're now adding a novel potential best in class -3-4 inhibitor, addressing gaps in the treatment of patients who face continued dyspnea or who are unlikely to receive inhaled corticosteroids or biologics because of their disease profile. Last but not least, the Camelopixin COM1 and COM2 trials remain on track and will be reported together in 2026. Next slide, please. In immunology, we're extending our expertise in inflammation to understand how it leads to fibrosis in the lung, liver and kidneys to treat, prevent and stop disease progression. Fibrootic diseases are thought to account for 45% of all deaths worldwide. So there's a major and met need here. These conditions are typically seen as difficult to treat, but our work in human genetics and phenotyping, combined with emerging platform technologies, including oligonucleotides, which have a unique ability to modulate gene expression in the liver, is showing real promise. As a result, we now have a growing hepatology pipeline with assets to treat chronic hepatitis B as well as steatotic liver disease or SLD, starting in metabolic dysfunction associated steatohepatitis or MASH and alcohol associated liver disease or ALD. Let's start with hepatitis B, a considerable market opportunity with large and met need and limited standard of care. With the periversin and oligonucleotide, we have an exciting opportunity for a functional cure. Promising data from the Phase 2 B-Clear and B-SURE studies demonstrates sustained loss of hep B surface antigen below the level of quantification. Importantly, new insights from recent epidemiological studies have shown that loss of surface antigen reduces all-cause mortality by up to 62% and the risk of developing liver cancer by up to 89% in HPV patients. We expect to present additional follow-up data from B-SURE at AASLD later this year. Our Phase 3 B well trial continues apace with data expected in the first half of 2026. I'm also delighted to share that the B-United Phase 2 study has completed recruitment four months ahead of schedule. This trial is looking at sequential administration of Daphylocirin and Tomlugicirin, followed by BEPI, which we'll read out in 2027. If positive, it will significantly expand the patient population who could benefit from treatment. As already highlighted, we're also excited to complete the acquisition of aphemus firmin or EFI. This adds another Phase 3 ready potential -in-class medicine to our pipeline. EFI is a once-monthly FGF21 analogue with Phase 2 data which demonstrates its potential to reverse liver fibrosis in MASH. We plan to start Phase 3 trials in MASH later this year, with plans for further development in ALD. And of course, development of GSK990, our siRNA therapeutic, continues for other subsets of patients with SLD. We see these two assets as complementary, providing options to develop both monotherapies and combinations. Let's turn to oncology now. Next slide, please. Here, our momentum continues, and we're rapidly expanding beyond our current focus in hematological and gynaecological cancers to treat additional solid tumours. On Blenheim, as Emma has said, the new PIDFA date is the 23rd of October 2025, providing the FDA with time to review additional information provided in support of the application. We're in constructive discussions with the FDA. And while I know you'll want more details, the review process remains confidential. And so I'll update you when we can. Outside the US, we've already received regulatory approvals from Europe, Japan, Canada, the UK and Switzerland, all pointing to the positive impact this medicine can have for patients with multiple myeloma. Elsewhere in the portfolio, we're progressing multiple development programs. Last year, GenPirly was expanded to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immunocollegy based treatment to show an overall survival benefit in these indications. Initial results from the ASIO1 trial in rectal cancer are expected in 2026, with the Phase 3 jade study in locally advanced head and neck cancer also ongoing. For Ajara, studies are underway to expand the label into MDS and additional indications are also in planning. We have a high ambition for our new ADC portfolio. And given the significant potential we see here, we're prioritizing investment. We are developing GSK227, our B7H3ADC, in lung cancer and evaluating other solid tumors. We've already received two breakthrough designations from the FDA in relapsed or refractory extensive stage small cell lung cancer and in late line relapsed or refractory osteosarcoma. Early combination data with PDL1 indicates the potential for a chemo free regimen in first line small cell lung cancer, with more mature data expected in November. And we're on track to start the pivotal study before the end of the year. For GSK584, our B7H4ADC will start pitiful studies early next year. Lastly, earlier this year we entered into an agreement to acquire IDRX42, a highly selective kit inhibitor being developed as a first and second line therapy for treatment of gastrointestinal stromal tumors or GIST. IDRX42, now GSK981, has demonstrated activity against all key primary and secondary kit mutations observed in GIST. This breadth of coverage, in addition to high selectivity, which could provide improved tolerability, offers a potential best in class profile. We'll start recruitment for a pivotal study in second line before year end. Next slide, please. Within infectious diseases, we're developing prevention and treatment options with broad coverage. Two of our recent FDA approvals exemplify this. PenMendV, our pentavalent meningococcal vaccine, offers more strain coverage, enabling higher protection from the serious consequences of infection to more teens and young adults. And Bligeppa is the first new class of antibiotic in over 30 years for the treatment of uncomplicated UTIs, a condition that affects 50% of all women. We're also making progress with other ID assets. Our phase three trial for Tebipenem and treatment of complicated UTIs was stopped early for efficacy. A RxV received a positive ACIP recommendation, expanding its use to adults aged 50 to 59. And the Shingwix, we're now researching this vaccine's potential for use beyond shingles. Given the increasing number of real-world evidence studies showing a potential protective effect in dementia, we've initiated several research collaborations to explore this effect prospectively. These include a first of its kind large scale linkage study with the UK Dementia Research Institute and Health Data Research UK. Of course, development work in HIV is also a clear priority, and you'll hear more from Deborah on this shortly. Next slide, please. I'm pleased with the strong momentum and material progress we're making in R&D. I believe we have more and better opportunities with 66 assets in full clinical development, 16 currently in late stage, and eight regulatory breakthrough designations already this year. Our deepening expertise in immunology, use of advanced technologies, and world-class partnerships are delivering results. We've had three FDA approvals so far this year and remain on track for two more. Adding to a record 13 positive phase three readouts in 2024, we expect another 15 readouts through 2025 and 2026. And for the remainder of this year, we'll start pivotal studies for four assets. Two of these are in oncology with our B7H3ADC in extensive stage small cell lung cancer and IDRX42 in second line GIST. In hepatology, we'll start a famous firminine mash and in HIV, a pivotal study for our Q4M ultra lung acting treatment regimen. Overall, we have a clear path to extend our leadership in respiratory, exciting new prospects in immunology and inflammation and momentum in oncology, alongside major pipeline opportunities to come in infectious disease and HIV. Next slide, please. To finish, I'll go back to where I started with our focus on the best in class pipeline in areas of huge unmet need, which you can see here. And when we're making an important difference to the health of billions of people. With that, I'll hand over to Luke.