GSK plc

Hello, everyone. Welcome to today's call and webcast. The presentation was sent to our distribution list by email, and you can also find it on gsk.com. Please turn to slide two. This is the usual safe harbor statement. We will comment on our performance using constant exchange rates or CER and excluding COVID solutions unless stated otherwise. Please turn to slide three. Today's call will last approximately one hour and 15 minutes, with the presentation taking around 40 minutes and the remaining time for your questions. Our speakers today are Emma Walmsley, Luke Miles, Julie Brown, and David Redfern, who will be covering HIV in the absence of Deborah Waterhouse, who's recovering from a successful medical procedure. And Tony Wood will be joining us for Q&A. Please ask only one to two questions so that everyone has a chance to participate. Turning to slide four, I will now hand the call to Emma.

Thank you, Jeff, and welcome to everyone joining us today. Today, we are reporting our 2024 results and providing you with updates on our growth outlooks, investment plans, and focus on improving shareholder returns. Please turn to the next slide. 2025 will mark three years since the demerger and the creation of GSK as a new dedicated biopharma company for patients and for shareholders. The demerger enabled a fundamental restructure of GSK and its balance sheet, bringing new capacity to invest in growth and to deliver returns to shareholders. Three years on, I'm pleased to say that we've seized this opportunity and made significant progress, building a strong track record of performance delivery. Specialty medicines and vaccines now dominate our reshaped portfolio and pipeline. Our long-term outlooks have consistently improved alongside the quality of our innovation. And we've delivered sustained year-on-year sharper operational performance underpinned by a stronger balance sheet. This all points to GSK having the platform to deliver sustained profit growth and returns in the short, medium and long term. Next slide, please. Our 2024 performance demonstrates the transformation of the business. Sales grew 8% to over £31 billion, with strong growth and increasing contribution from specialty medicines more than offsetting headwinds in vaccines. Core operating profit was up 13% and core EPS was up 12%. This level of performance delivered two upgrades to guidance in 2024 and supports the increased dividend of 61 pence per share announced today. I'm also pleased to report that we maintained good progress in our six priority areas to build trust, not least retaining a leadership position in the Access to Medicine Index, where we've been placed first or second in the industry since its inception in 2008. And of course, during the year, we also resolved the Zantac litigation, prioritizing shareholder interests. Next slide, please. Operational delivery in 2024 reflected strong growth and accelerating momentum of specialty medicines with double digit growth in all therapy areas and sales of oncology nearly doubling to more than £1.4 billion for the year. Vaccine sales reflect the challenges we've seen from external pressures in the US and China for OREXV and Shingrix. Going forward, we expect these to continue in 2025, but equally remain confident that OREXV, Shingrix and our vaccines pipeline will contribute meaningfully in the medium and long term. Importantly, 2025 will see further additions to GSK's portfolio with five new product approvals expected this year. At the forefront are potential step changes in treatment with Blenrep, our novel ADC treatment for multiple myeloma, and Depimocumab, our new long-acting IL-5 medicine for the treatment of severe asthma. Of these two, Blenrep will be the first to launch with an expected FDA PDUFA in July. Next slide, please. Last year, GSK had 13 positive phase three readouts, a record achievement for our R&D organization. I'm also pleased with the confirmed development and strengthening of our mid and early stage pipeline with positive clinical progress and the addition of several promising new assets in the areas of oncology and respiratory immunology and inflammation, or RINI. Next slide, please. So with all this progress to date, R&D is now heavily focused on the clinical development of 14 scale opportunities, with peak year sales potential above £2 billion and expected launches before 2031, and the majority in specialty medicines. In RI&I, we're prioritising Depimocumab, Nucala COPD, Camlipixent and long-acting IL-33, IL-5 and T-slip medicines. The aim here being to leverage GSK's deep expertise in inflammatory mechanisms, to lead in COPD, and to target new options to treat fibrotic lung, liver, and kidney diseases. In oncology, we're prioritizing resources to BlendRep and to the acceleration of our very promising ADCs, targeting B7H3 and B7H4 antigens, as well as continuing lifecycle innovation for Gemperli. In HIV, our plans for long-acting and ultra-long-acting treatment and prep options for four and six months are all progressing very well. And infectious disease, we're prioritising development of bepireversin, our potential functional cure for hep B, and of course, our high-potential new mRNA and MAPS vaccines. Alongside these, and as Tony started to outline in December, we're also prosecuting the early stage pipeline with a further 40 assets or so in phase one and two. Lastly, we continue to add new opportunities through targeted business development, the recent agreement to acquire IDRX being a great example of what we want to do here. Next slide, please. Looking at GSK's launch portfolio over the next five years, we expect it to offer scale opportunity for growth, together with an attractive risk profile. By 2031, we're increasing our outlook again and now expect risk-adjusted sales to be more than £40 billion. This increase reflects the inclusion of BlendRep, our significant phase three progress since last year, and multiple launch opportunities in the 26 to 31 period. With almost 90% of our 2031 sales ambition coming from products already approved or planned for launch in the next three years, we're confident that our portfolio will deliver against this guidance. In terms of contribution, we now expect specialty medicines to be more than 50% of sales by 2031, with this area being the key growth driver for GSK over the next few years too, reflecting the high number of opportunities we have in the maturing late-stage pipeline for specialty products, particularly in RNI and oncology. For vaccines, while we've adjusted expectations to accommodate for new sales growth trajectories of Rexvi and Shingrix over this period, as you can see here, we continue to expect this part of GSK's business to remain a key source of future growth. General medicines will also remain an important and relatively stable contributor to sales over the period. As before, we have further upside from our early stage pipeline, including notably Q6 month HIV and prospective BD, where we will continue to pursue smart opportunities at the same kind of scale and pace seen in recent years. And as you can see from the two bars here, there is significant potential for upside with successful clinical outcomes. Next slide, please. Overall, then, we continue to set out positive outlooks for growth in the short, medium and long term. And we are all strongly committed to maintaining our track record of delivering this together. We expect 2025 will be another year of profitable growth led by specialty medicines. And with our recent progress, we're now even more confident in our ability to deliver not only our 26, but also our new 2031 outlooks. All of this while retaining the flexibility we need to invest competitively in growth and to deliver improving returns to shareholders. Next slide, please. we remain extremely focused on disciplined allocation of capital. Our first priority for capital remains to invest in growth and in R&D. With the pipeline opportunities we now have, we are deliberately prioritizing investment to accelerate development of key assets in R&I and oncology, alongside long-acting HIV medicines and existing core vaccines opportunities. In addition to growth, we also remain focused on delivering improving returns for shareholders. Our primary mechanism for this remains via delivery of a progressive dividend. For 2024, we've declared 61 pence and we expect to pay 64 pence in 2025. And as we've previously said, we also look to deliver returns using other mechanisms when circumstances and opportunities allow. And today we are announcing our intention to buy back up to two billion pounds of shares over the next 18 months. We believe this offers a very attractive return for shareholders at current share price levels. Very importantly, and to reconfirm, we will maintain planned increased levels of investment in R&D, new launches and targeted business development alongside these share buybacks. So let me now hand over to Luke to start to take you through more detail on our 2024 performance and the prospects we see for some of our near-term growth drivers.

Thanks, Emma. Please turn to the next slide. As Emma highlighted, overall sales for the year were up 8%, with strong growth from specialty and general medicines, more than offsetting short-term headwinds, primarily in the US, to our vaccines business. Next slide, please. Specialty medicines continues to show excellent momentum and pipeline progress. And as Emma said, it's now expected to be over half our business by 2031. In 2024, specialty grew 19%, with strong performances across all therapy areas. Respiratory immunology products were up 13% in the year. Nucala, our anti-IL5 biologic treatment, grew 12%, driven by strong performances in Europe and international. Ben Lister, our treatment for lupus, was up 14% in the year, with strong demand across all regions. In oncology, sales almost doubled in the year. Cedula grew 17% with strong growth across all regions, driven by sustained increases in patient demand. Gemperli sales more than tripled in 2024, benefiting from increased patient uptake in the US following FDA or Comer's approval for primary advanced or recurrent endometrial cancer. And we received EMEA or Comer's approval in January this year. OJARA sales increased more than 10 times in the year, largely driven by continued strong uptake in the US. Contributions from Europe and international are also increasing following launches in the UK, Germany and Japan, and we expect further launches in 2025. David will cover HIV shortly. We expect the excellent momentum in our specialty medicines portfolio to continue in 2025 with sales growth of low double-digit percent while absorbing the IRA impact. Next slide, please. Looking at what's next in specialty, in R, I and I, we are targeting a major new indication for Nucala to treat COPD following positive headline results from our phase three matinee trial. COPD affects more than 300 million people globally, and it's the third leading cause of death worldwide, excluding COVID. An FDA decision is expected ahead of the 7th of May VDUFA date, and launch preparations are fully underway. We plan to publish the full matinee results at this year's ATS meeting. Depomocumab, our new long-acting anti-IL-5 medicine, has now been filed in all major markets for dual approval in severe asthma and chronic rhinocytosis with nasal polyps. Depomocumab has the potential to be the first approved ultra-long-acting biologic with six-month dosing, offering physicians and patients the reassurance of prolonged efficacy through sustained suppression of inflammation and could improve compliance and adherence for patients with severe asthma. We expect more Phase 3 readouts over the next 18 months for other eosinophil-driven indications and also plan to start a Phase 3 trial in COPD this year. And we have Camlopixin, a highly selective P2X3 antagonist with the potential to be a best-in-class medicine for treatment of refractory chronic cough, a disease with significant unmet need. First data from the Phase 3 CALM development program are expected this year with more early next year. In oncology, we're working to realise the full potential of our existing medicines, as well as to expand our portfolio in areas of high unmet need. We have significant potential assets to drive growth for GSK, and I am very optimistic about what we as GSK can deliver here. We're building a portfolio of novel pipeline ADCs with the ability to target tumour cells while sparing healthy ones. GSK227 targets B7H3, an antigen which is overexpressed in a wide range of solid tumors. Early data show promising clinical activity, and we expect to share updated small cell lung, osteosarcoma, and additional data from our clinical development programs at the ASCO and ESMO conferences this year. Pivotal studies for 227 are expected to start before the end of the year. GSK584 targets B7H4, which is also overexpressed across a number of solid tumors. And our initial focus here is for the treatment of ovarian and endometrial cancers. Again, we expect to share more data on 584 at the conferences of this year. As you may have seen, we started 2025 with the announcement to acquire IDRX. This gives us access to IDRX4-2, a very promising and highly selective kit tyrosine kinase inhibitor designed to treat gastrointestinal stromal tumours. This adds to our GI cancer portfolio and we plan to accelerate development of this exciting asset. Lastly, as a reminder, we also expect initial results from Azure 1 and Azure 2 trials exploring Gemperli in rectal and colon cancer in 2026 and 2027 respectively, and the Phase 3 JADE study to read out in 2028. All this highlights the very strong progress GSK is making in oncology. 2025 will be another key year with the launch of Blenrep. Next slide, please. Blenrep is at the forefront of our ADC portfolio. In December, we presented overall survival data from the DREAM7 second-line multiple myeloma study at ASH, and the data demonstrated a statistically significant and clinically meaningful 42% reduction in the risk of death when comparing Blenrep to the daratumumab-based standard of care. Median overall survival has not yet been reached in DREAM 7, but the projected difference is 33 months. For context, that's almost an additional three years of survival versus the current standard of care. If approved, unlike a number of alternative second-line treatments, Blendrep would be an off-the-shelf treatment option delivered by a 30-minute infusion in a community setting with no requirements for pre-infusion protocols, hospital admission, or post-infusion monitoring. This could be important for the 70% of patients treated in the community. In the newly diagnosed or first-line setting, we're encouraged by the second-line trial readouts, but also by the BELLA-RD trial, which demonstrated 100% response rates. Our pivotal trial for Blenrep in the first line, DREAM10, started recruitment at the end of 2024, and we anticipate headline results towards the end of 2027. Next slide, please. I remain very ambitious for Blenrep, which I believe will become an important new growth driver for GSK. We have gained extensive experience of treating patients with Blenrep and have a better understanding of how to mitigate eye-related side effects. Around a third of patients in Blenrep studies have reported blurred vision as an adverse event, but for the vast majority of these patients, this was manageable, transient, and reversible, and data suggest did not impact patients' quality of life. Eye-related side effects in DREAM7 were generally managed by dose modification, for example, by extending the interval between doses. Data recently presented at ASH showed that when dosing intervals were extended from 8 to 12 weeks, the incidence of ocular events declined, and critically, the efficacy of BlendRit was maintained. We've completed a number of regulatory filings and have an FDA BDUFA date of July 23. As we prepare for BlendRep's launch, market research tells us intent to prescribe has significantly improved, with the overall survival data a strong motivator. However, ACPs are mindful of eye-related side effects and therefore educating them in the appropriate dosing will be key. As a result, in the initial phase, we expect a staged ramp-up as we build physician experience for the medium to longer term. I'll now hand over to David to talk through HIV before I cover vaccines and general medicines.