GSK plc

For example, I'm excited by GSK261, a new monoclonal antibody for polycystic kidney disease, which received orphan drug designation by the FDA. Lastly, and very importantly, we continue to optimize our supply chain to scale up capacity for our new medicines and vaccines. Last month, we confirmed our intention to invest $30 billion in R&D and advanced manufacturing in the US over the next five years, including the imminent construction of a new biologics flex factory in Pennsylvania. Next slide, please. Since 2021 and then GSK's successful launch as a new focused biopharma company, we've delivered 18 consecutive quarters of profitable sales growth, upgraded annual guidance each year, improved our medium-term outlooks and upgraded long-term outlooks twice from an initial 33 billion pounds by 2031 to now more than 40 billion pounds. all underpinned by a much stronger balance sheet. We've all been resolutely focused on this step change in sharper operational performance, alongside accelerating investment in R&D and significantly improving the quality and scale of GSK's innovation. So today, GSK is a very different company in performance, pipeline, and prospects. And this team is determined to sustain and improve upon this track record. As we look ahead, we are again upgrading our guidance for the year with meaningful improvement for 2025 sales and profits. And this momentum positions us well as we go into 2026 and to deliver on the long term commitments for growth we've set out for shareholders. So let me now hand over to the team to take you through more of the detail on our performance, starting with Luke. Next slide, please.

Thanks, Emma. Please turn to the next slide. In Q3, we delivered growth across all our product areas and in the regions with 8.5 billion pounds of sales, up 8% versus last year. Growth in the quarter was driven by specialty medicines, up 16%, and another quarter of strong Shingrix, Orexi, and meningitis demand in Europe. And in the US, we navigated the impact of the Medicare redesign from the IRA, and the impact is now expected to be closer to the lower end of our 400 to 500 million pound range. Next slide, please. Specialty medicine continues to be the most important driver of our diversified business with double digit growth once again in all therapy areas. Starting with RI&I, sales were up 15% driven by strong demand. Benlysta, our treatment for lupus, grew 17% with global guidelines supporting earlier use of biologics and recommending Benlysta as a preferred treatment option. 84% of BI&I patients are now starting on Benlysta and we continue to differentiate with strong organ damage prevention data and a well-characterized safety profile. Eukala, our anti-IL5 biologic, grew 14% in the quarter, driven by COPD update and continued growth across all inline indications. Moving to our growing oncology portfolio, which is up 39%, Gemperli sales were up for the 10th quarter in a row as our teams continue to differentiate Gemperli from the competition. as the only immuno-oncology medicine to demonstrate overall survival in endometrial cancer. Gemperley's global market share in endometrial cancer is now higher than the leading competitor in DMMR. And our Jira sales were up 51% in the quarter, driven by increasing first and second line patient demand in the US, and volume growth in Europe following IHA, where new data emphasise the importance of early intervention. And Blenrep is now in the early days of launch, with approval in eight markets and more on that in a minute. And with the strong momentum we're seeing across RNI and oncology and the continued performance of VEVE, we are now increasing our full year specialty guidance from low teens to mid teens percentage growth. Next slide, please. In Q3, we had a very strong start for Nucyla and COPD with the latest NBRX data showing we are now getting close to one out of every two prescriptions. A differentiated label is enabling us to reach a wide spectrum of COPD patients, including those with emphysema and EOS counts down to 150. We've now reached 95% of our top ACP targets and have a broad formulary coverage. In this population, hospitalisations remain a critical unmet need, with one in two patients dying within five years of their first admission, and there is plenty of room to grow in this market with less than 5% biologic penetration in the US. The success we have had with this launch gives us further confidence in the potential we have for deprimocumab, a long-acting IL-5, which we expect to launch early next year. There are four compelling reasons underpinning why we believe DEPI will be a very material medicine. First, there's plenty of room to grow in the market, starting with bionic patients, as only 27% of them currently receive a biologic. Second, patients discontinuing therapy is an issue, with up to 65% of new patients on current biologics discontinuing therapy within the first 12 months. And unsurprisingly, less adherent patients have worse clinical outcomes, including around a 30% increased rate of inpatient and emergency department visits. The 72% reduction that DEPI has demonstrated in hospitalisation with just two doses a year is material. And finally, we know ACPs want this medicine. 86% of pulmonologists surveyed believing it could become a standard of care. Next slide, please. Our oncology portfolio is progressing well. Starting with Blenrep, we now have approval in eight markets, seven in Europe and international regions in the second line plus population, and now the US where just last week we received approval in the third line plus setting. This US approval is a significant step forward for the US patients and the indication granted reflects that Blenrep has demonstrated superior efficacy versus a standard of care daratumumab triplet and now gives us certainty and the ability to launch. Data from DREAM7 in this population is very compelling, with a 51% reduction in the risk of death and a tripling of median progression-free survival versus the DARA-based triplet. We see a significant opportunity here as of the 71,000 patients in the US receiving treatment today, over a third are treated in the third line plus setting. And BlendRip is the only anti-BCMA option which is practically able to be used in the community. where 70% of patients are treated and could benefit from a much needed novel MOA. We also have a new and significantly simplified REMS program, including importantly, the use of optometrists versus the original REMS, which required ophthalmologists only. This will make it much easier for patients and HCPs to manage eye care. And while we anticipate a slower ramp up in the US with the initial third line plus, label as we said previously we will take the time to ensure a positive patient and provider experience to achieve the long-term potential of this highly effective drug a clinical development and evidence generation plan continues and again working closely with the fda this will now be expanded in the us and will support the use of blend rep in earlier and all stages of multiple myeloma globally In summary, we expect BlendRap to meaningfully advance treatment options for patients with multiple myeloma, and we continue to expect BlendRap to be a material growth driver for GSK in the next three to four years. Moving to future indications for gemperline, we're looking forward to the opportunity we have to change the lives of patients with rectal cancer. And following the transformative data showing a 100% complete response rate in phase two, we initiated the Azur1 pivotal trial and expect to see results in the second half of 2026. and additional trials are ongoing to understand the benefit Gemperli can bring patients with colon and head and neck cancer. Finally, we continue to progress our key oncology pipeline assets, starting with our B7AH3 antibody drug conjugate, or GSK227. We're now recruiting for our phase three trial and second line extensive stage small cell lung, following a clear signal we saw in the early stage clinical data from Hanso, our partner. And our kit inhibitor for GIST, GSK981, acquired earlier this year, will start phase three in second line by the end of the year and first line in 2026. And GSK584, B7H4 antibody drug conjugate, is expected to advance to phase three in endometrial and ovarian cancer next year. Overall, this oncology portfolio offers significant future growth opportunities for GSK and is a clear priority for investment and resources alongside RII. And with that, I'll now hand over to Deborah to cover our great momentum in HIV.

Thank you, Luke. Our HIV portfolio continues to deliver double-digit growth, up 12% in the quarter, primarily driven by 10 points of strong patient demand growth for our long-acting injectables and Dovato. Demand continues to increase across all regions and major markets, particularly the US, which grew 17%, and where we saw total share gain outpacing the competition. we are delighted with the continued transition we are seeing to long-acting injectables. More than 75% of our growth now comes from long-acting injectables, and in the US, they already represent around a third of our sales. Cabinuva, the first and only long-acting injectable HIV treatment regimen, grew 48%, driven by strong patient demand. Our competitive performance is reinforced by the acceleration of Cabinuva switches from competitors in the US, which this quarter reached 75%. As we anticipated, in long-acting prevention, we saw continued positive momentum of aptitude in the US, with competitive growth also of 75%. This quarter, we shared results from CLARITY, a phase one study comparing acceptability and tolerability of single dose CAB-LA for PrEP marketed as Apertude and Lenacapavir. We know patient experience is an important factor for injectables. Results showed 69% of participants found CAB-LA to be totally or very acceptable. with 90% of participants and 86% of HCPs preferring Cabele over Lenacapavir in terms of injection experience after a single dose. These data add to the growing body of clinical and real-world efficacy, safety and tolerability data we have for Aperture and will help inform expectations and decision-making when initiating long-acting injectables for HIV prevention. We expect continued growth momentum in Q4 and so today we are upgrading our 2025 guidance from mid to high single digit to grow around 10%. Next slide please. Our industry leading pipeline with best in class integrase inhibitors at the core continues to progress and have multiple long acting options with strong profiles that deliver what we know patients want and need. This pipeline will further drive the transition we are making in our portfolio to ultra-long acting regimens and will help us navigate the dolotegravir loss of exclusivity towards the end of the decade. Building on our established two monthly injectable regimens, we believe four monthly dosing in prep and treatment will be important options, delivering longer dosing intervals and ensuring continuity of care. We have a confirmed date from Janssen on rilpivirine phase three clinical trial supply that leads to a delay to the start of Quattro, our Q4M treatment registrational study, to H1 2026. Despite this, we remain on track to file in 2027, and we look forward to launching this next wave of innovation in 2028, building on continued strength and performance of our Q2M Cabinuva, the world's first and only LAI for HIV treatment. At the launch of Q4M treatment, we still expect to have the only long-acting injectable treatment regimens on the market for years to come. Looking ahead to our twice yearly injectables, we're on track to confirm the dosing regimen for Q6M treatment in 2026 and expect to file and launch both Q6M for treatment and PrEP between 2028 and 2030. For Q6M treatment, we remain excited about the potential of VH184, our third generation INSTI, which has the best resistance profile seen to date and IP protection through to at least 2040. To partner with our selected INSTI, we are evaluating two assets, VH499, a capsid inhibitor, N6LS, one of the broadest and most potent BNABs in development. Regarding N6LS, this quarter we again showed more positive results from part two of our phase 2B study embrace and are pleased to confirm the next phase of this study is now fully recruited. As a reminder, Q6M for treatment and prep is not yet in GSK's outlook for 2031. Our long-acting injectable portfolio is backed by three years of real-world evidence and implementation science. As we look to the future, we expect our industry-leading long-acting pipeline, powered by unparalleled patient insight, to deliver five launches through 2030. We remain confident in our ability to drive sustained, long-term performance and look forward to sharing more at a Meet the Management investor event in Q2 2026. With that, I'll hand back to Luke.