GSK plc

Hello, everyone. Welcome to today's call and webcast. The Q3 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, unless stated otherwise. Please turn to slide three. Today's call will last approximately one hour, with the presentation taking around 30 minutes and the remaining time for your questions. Our speakers today are Emma Walmsley, Luke Miles, Deborah Waterhouse, and Julie Brown, with Tony Wood and David Redfern joining 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.

Welcome to everybody joining us today. Please turn to the next slide. I'm pleased to report that despite some challenges, this has been a positive quarter for GSK, and we're delivering 9% sales growth and 19% profit growth year to date. This growth reflects the accelerating momentum we have in specialty medicines and the overall resilience we have built in our portfolio, which underpins continued high confidence in our outlooks for 2026 and beyond. Importantly, we've made considerable progress in our pipeline this quarter. And with no admitted fault or failure, I'm delighted that we've also drawn a line under the vast majority of Zantac litigation, removing a clear perceived risk for the company and allowing us to focus on the future. Overall, excluding COVID, sales for the quarter grew 2%, 9% year-to-date, with specialty medicines up 19% and double-digit growth reported in HIV, respiratory immunology and oncology. We were particularly pleased to see the momentum now being established in our oncology business, and I'm delighted that we filed Blenrep in Europe, Japan, and the US in the quarter. We also continue to see strong progress in the transition of our HIV portfolio to long-acting medicines, now 18% of HIV sales, and where we plan to continue to lead the way. General medicines also performed strongly this quarter, with growth up 7%, led by another outstanding performance from Trilogy. Total vaccine sales were down due to lower sales of OREXV and Shingrix. Recent guideline changes and prioritisation of COVID vaccines in the US were key factors. But market shares for both these vaccines remain very strong. Although both vaccines face market circumstances that will limit their growth potential in the near term, over the medium and longer term, the fundamental benefits these two best-in-class vaccines offer to protect people from disease and to take pressure off healthcare systems remain. And with appropriate recommendations from public health authorities, we fully expect them and our vaccines pipeline to deliver significant future sales growth for GSK. Back to this quarter, we continue to deliver strong operating performance and leverage. Excluding COVID, core operating profit and core EPS growth were both up 5%, reflecting the positive margin benefit of specialty medicines and sustained focus on cost management. Year to date, operating profit was up 19%, supporting double-digit profit growth for the year. Lastly, we're reporting further improvements in cash flow, with cash generated from operations of £5.3 billion year to date. This is providing increased funds for pipeline investment and returns to shareholders. Our dividend for the quarter is 15 pence, up 7%. Next slide, please. Pipeline progress was strongly evident in the quarter, with a series of filings and data readouts supporting future product momentum. So far this year, we've had 11 positive Phase 3 readouts, and we're currently planning launches for five major new product approval opportunities next year, with Blenrep, Depimocumab, Nucala for COPD, Jepitidacin, and our new meningitis vaccine, MenABCWY. In the quarter, pivotal data from our ultra-long-acting biologic Depimocumab in severe asthma was front and centre at the European Respiratory Society Congress and simultaneously published in the New England Journal of Medicine. Additionally, we announced positive results from our Phase 3 trial of Nucala in COPD. In oncology, we were delighted that Jen Purley received an expanded approval by the FDA for all adult patients with primary advanced or recurrent endometrial cancer. And Blenrep is now filed with multiple regulators, including the US. I was also delighted to see the positive headline data from our mRNA influenza vaccine candidate, demonstrating positive A and B strain immune responses relative to standard of care, enabling us to progress to phase three clinical trials next year and build another key vaccine platform. And we received a number of breakthrough regulatory designations, recognising the importance of our innovation for unmet medical needs. This included beperivircin, our antisense oligonucleotide for chronic hepatitis B, and B7H3, our antibody drug conjugate for extensive stage small cell lung cancer. B7H3 is one of two promising ADCs we have in clinical development and part of the next wave portfolio now emerging in R&D, which Tony's going to update you on at our next Meet the Management event in December. Next slide, please. Building trust by delivering sustainable health impact remains a clear priority for all of us at GSK. We continue to make progress across our six key areas. And I'd particularly like to recognize our HIV business for its commitment to make at least 2 million doses of cabotegravir long acting for prevention available in low and middle income countries during 25 and 26. This further commitment builds on longstanding action to deliver sustainable access and triple supply compared to 2024. Please turn to the next slide. GSK is delivering consistent financial performance. Looking to the end of this year and beyond, we're even more confident that the progress we're making in portfolio development and in R&D support the delivery of our growth outlooks. For 2024, we continue to anticipate sales growth of 7% to 9% with double digit profit growth. We also remain very confident in our outlooks for 26 and 2031 and our investment choices to drive competitive growth in specialty and vaccines. It's also worth remembering that these outlooks do not yet include blend rep or progress in our early stage pipeline. And we'll continue to pursue bolt-on business development to further enhance our pipeline and our technology platforms with a focus on our core therapeutic areas. So with that, I'll now hand over to Luke and Deborah to talk you through our commercial performance.

Thanks, Emma. Please turn to the next slide. Third quarter sales were up 2% to 8 billion pounds and year-to-date sales were up 9%. As you can see from the chart here, Q3 sales growth reflected a tough comparison with strong growth from specialty and gen meds offsetting the lower sales of vaccines. Specialty medicines, the largest part of our business, grew 19%, reflecting strong performance of new products and the investment we've put into recent launches, particularly in oncology and HIV. We expect this momentum to continue with growth from these assets and several material launch opportunities in respiratory, oncology and other disease areas coming later next year. General medicines pleased to say sales were up 7% driven by strong performance of respiratory. And as already been mentioned, lower demand for Shingrix and Orexvi this quarter led to an overall sales decline of 15% for vaccines. And I'll cover this in more detail in a minute. All of these dynamics were broadly reflected in the performance of our regions with good growth internationally and the US unsurprisingly was more impacted by the lower vaccine demand we saw this quarter. Please turn to slide 11 to look at vaccines in more detail. So I'll focus the commentary on OREXV and Shingrix. OREXV performance was impacted by three factors. Firstly, by changes in ACIP guidelines that restricted the recommended populations of older adults receiving RSV vaccinations. Secondly, by prioritization of COVID vaccinations in the U.S., And thirdly, by a lower seasonal rate of RSV infections. In addition, it was a tough comparator given two thirds of sales in Q3 last year were related to stocking. Despite these dynamics, we retained our strong leadership market share. Now, we're still in the foothills of this vaccine's availability and usage. In the US, we continue to make data available to ACIP and to support them as they move towards making longer-term recommendations on the use of RSV vaccines, including requirements for revaccination and cohort expansion. Beyond the US, REXFE is now launched in 35 markets, 16 with national recommendations and six with national reimbursement programs. More rollouts across Europe and international will come in 2025. For Shingrix, year-to-date growth was driven outside the US, now 58% of the business, and the average immunization rate across the top 10 markets, excluding the US, is still around 6%. So there's still a large opportunity here. Growth outside the US was 9% this quarter, and US penetration was 39% at the end of the second quarter. Adding to US penetration remains a key focus. But the pace is slowing from around six to seven points per year, to around three to five points per year, making incremental growth more challenging. And if you take a look, the visual on this slide also shows how US sales moderate as the immunisation rate slows. Next slide, please. So looking ahead on vaccines, this year we now expect vaccine sales to decline low to single digits. And in 2025, we expect limited growth, reflecting the assumption that there will be no orexiv revaccination or expansion of age cohorts next year. Beyond 2025, for RxV, we expect further successful rollout and that public health recommendations for cohort expansion and revaccination will be confirmed alongside international penetration given the patient need and the protection this vaccine can offer against RSV. And so on this basis, we continue to expect OREXV to make a significant contribution to future sales, and we continue to believe it can achieve peak sales of more than 3 billion pounds. For Shingrix, our ambition remains to achieve more than 4 billion pounds in sales. And finally, beyond OREXV and Shingrix, we also have material growth opportunities with mRNA and our MAPS technology, where we've decided to prioritise a pneumococcal 30 plus valent asset in adults to pursue the broadest potential coverage and further build out of our meningitis portfolio, the next step of which will be the launch of our MEN-ABC-WY vaccine in 2025. Next slide, please. Specialty meds is an increasingly important driver of our growth for GSK, reflecting the combination of successful R&D and BD investment over the recent years. And it's delivered another quarter of excellent growth, including HIV, which Deborah will cover shortly. Respiratory and immunology products were up 14%, and Nucala IL-5 biologic treatment was up 12%. In September, we announced positive headline results from MATINAE, a phase three trial evaluating Nucala in adults with COPD, a disease which affects more than 300 million people. And the full results will be presented at a scientific congress next year. We also presented SWIFT phase 3 data for our ultra-long-acting IL-5 treatment, Depomocumab in the quarter, and Depomocumab demonstrated a 54% reduction in exacerbations versus placebo, plus standard of care for patients with severe asthma after only two injections in a 12-month period. This is a major benefit for provider and patients. In addition, positive data from the Phase 3 ANCA study evaluating Depomocomab in patients with chronic rhinositis with nasal polyps was also announced this month. Alongside SWIFT, these data will support expected filing before the end of the year with a view to a dual indication launch in 2025. And to remind you, combined, we expect our IL5 portfolio to deliver more than £4 billion in peak year sales. Ben Lister is up 16% in the quarter with strong demand and volume growth in all regions and oncology almost doubled, which I'll cover in more detail on the next slide. We expect momentum in this part of our portfolio to continue, especially given the launch opportunities we have in front of us. And for this year, we're upgrading sales expectations for specialty medicines to high teens percentage growth. Next slide, please. Focusing on oncology, sales almost doubled in the quarter, and we've delivered more than £1 billion in turnover so far this year. Our focus on haematology and gynaecologic cancers is delivering strong progress, evidenced by the success of new product launches in these areas. OJARA, which has launched in the US, Europe, and very recently in Japan, has seen quick adoption with high quarter-on-quarter growth. And in the US, it's maintaining its fast launch uptake, and there's still a large opportunity remaining in first line. Gemperley cells also continue to grow strongly. In August, the US FDA approved Gemperley plus chemotherapy for the treatment of adult patients with primary, advanced, or recurrent endometrial cancer. This approval broadens the previous indication to include the 70 to 75% of patients diagnosed with endometrial cancer who have mismatched, rare, proficient, microstatelite-stable tumors. And treatment options have been limited for this cohort, so it's important Gemperley is now available to these patients. Zedula's growth continued in Q3, driven by US pricing effects and high demand outside the US. And looking ahead, we have a significant opportunity to strengthen our oncology business with the launch of Blenrep in half to 2025. We filed for approval in the US, EMA and Japan in the quarter. Next slide, please. General medicines grew 7% in Q3, primarily driven by Trilogy, and Trilogy sales increased 16% to 600 million pounds with strong growth across all regions, reflecting patient demand, class growth, and increased market share in the overall asthma and COPD market. Use of authorised generic versions of Advir and Flovent are continuing to fully offset the removal of the AMCAP on Medicaid drug prices in the US. And given our stronger performance this year, we now expect mid single digit percent sales growth for general medicines this year. Looking forward for the total business, the US is expected to face pressure from the implementation of the US Inflation Reduction Act legislation in 2025.