GSK plc(GSK)Q2 2026 法說會逐字稿

Good afternoon, and welcome to this GSK Q2 Results and Accelerate Growth event. Today, we look forward to having a good event. And if we could have the agenda slide on the screen, please. Just a few words on logistics before I hand over to Luke. The first thing is that we have a Q&A session for you planned at 2:45 and another one then at 4:20. After the first Q&A, you will have a short break, and the event is planned to end around 5:00 p.m. Next slide, please. Also note the legal disclaimer on our cautionary statement regarding forward-looking statements. And I would like to add that any definitions in terms of our reporting as well as assumptions on accelerated growth can be found at the end of this deck. Lastly, if we comment on performance, any of these comments will be made at constant currency or CER, unless otherwise stated. And with this, I'm delighted to hand over to Luke.

Thank you. Welcome, everyone, and thanks for investing your time here to join us in person at the London Stock Exchange and on the webcast. If anyone wants photos of the South Cambridge Railway Station, which is a lovely orange color, Mick Readey has them, so we can send them to you after. Seriously, today is in 2 parts. The first, we'll give you an overview of our Q2 results. Then we'll move to what is the primary focus of today, which is GSK products and our plan to grow the business and how we'll create value for both patients and shareholders. So first, I'll cover the results we announced today quickly. So Q2 performance was strong. We've got continued operational momentum with sales up 5% to more than GBP 8.4 billion. Core operating profit grew 7% and core earnings per share were up 9%. Our cash generation remains very positive at GBP 4.3 billion, and our Q2 dividend is 17p. And we're on track in terms of our responsible business rating. In July, we also closed the acquisition of Nuvalent. Nuvalent is a precision oncology company closely aligned to our approach to R&D. And I'm delighted to say that this acquisition has already contributed to our portfolio with the approval of Jideytro, in pretreated ROS1-positive non-small cell lung cancer just last week. Looking forward, we are updating our full year 2026 guidance with sales and operating profit now towards the upper half of the range with EPS now expected in the lower half of the range following the acquisition of Nuvalent. I'll now hand over to Nina, who is going to summarize how we're delivering this growth and she'll also take you through some color on Nucala and COPD, Exdensur and Blenrep.

Thank you, Luke. Hi, everyone. So commercial momentum continued in the second quarter, driven by key products across our specialty and vaccines portfolio. Growth was driven by Specialty Medicines, which grew 14% and vaccines, which grew 8%. Vaccines growth benefited from the global expansion of Arexvy, our RSV vaccine, strong performance from our meningitis vaccines and Shingrix in Europe. Specifically, Arexvy benefited from a tender win for a 2-year supply in Australia. Specialty growth was driven by Nucala's continued COPD launch and its halo effect on the other indications, and our long-acting HIV treatment, Cabenuva as well as Dovato. General Medicines was down 9% in the quarter with declining sales of the older established portfolio. Also, there was a challenging pricing comparator for Trelegy in the U.S. due to a positive true-up that took place in the second quarter last year, and also softer inhaled respiratory market demand, both of which we expect to improve in the second half of this year. As Luke mentioned, we are focused on the products that drive the most value, including new launches and growth contributors. Next slide, please. Here, we have pulled out the 3 major launches of 2026. Starting with Nucala. We once again had strong global growth driven by the COPD launch and its halo effect on the other indications. In the U.S., new-to-brand prescriptions were up 69%, with COPD driving more than 70% of the growth. Internationally, sales were up 18%, primarily driven by our success in China, where Nucala gained majority share of bio-naive patients in COPD and already has NRDL listing in severe asthma and nasal polyps. We are also continuing with the launch of Exdensur, our twice-yearly IL-5 for severe asthma. The J-code went live on July 1, reducing the logistical burden on prescribers and providing certainty on reimbursement. We are continuing to build access and coverage with more than 50% of insured patients now being covered. The majority of new patients are coming from the bio-naive population, which we expect will continue as around 70% of patients who could be on a biologic for severe asthma still are not. And finally, Blenrep, our community-ready antibody drug conjugate for multiple myeloma is building in line with our expectations. We now have approval in 49 countries. And recently, we have gained reimbursement for Germany and Spain. In the U.K., that's the country where Blenrep launched first, we are seeing a shift in second-line treatment, as shown in this very nice chart provided directly by NICE, with Blenrep now leading in new patient starts. In the U.S., we are receiving positive feedback from physicians with strong intent to continue use. As we've said before, our approach is to go slow to ensure positive experience, helped by the J-code, which is now in effect for Blenrep as well. As we enter the second half of the year, we will continue to focus on unlocking the community opportunity where the majority of the patients are. And with that, I will hand over to Deborah.

Thanks, Nina. I'm delighted to report another quarter of double-digit sales growth at 10%, reflecting continued execution of our strategy and sustained market growth for our long-acting injectable portfolio, which in Q2 represented 80% of our total HIV growth. In the U.S., we accelerated our market share growth, continuing to outpace the competition with sales growing 14%. Long-acting injectables contributed 35% of sales, underscoring strong execution in a competitive market and increased demand for our HIV medicines. Cabenuva continued to convert patient preference into sustained growth with sales plus 33%. This performance was fueled by patient demand. And in the U.S., 77% of new prescriptions came from competitor products, reflecting increasing confidence among both health care providers and people living with HIV and the benefits of long-acting treatment. Apretude sales increased 39%, supported by more than 4 years of real-world evidence and tolerability data. At AIDS 2026, 6-month follow-up clarity data further reinforced a more favorable injection experience versus lenacapavir after a single dose of each drug with 70% of participants rating CAB as very or totally acceptable compared with 37% for LEN. In addition, fewer HCPs reported challenges with administration and patient management. Given our continued growth momentum, we are raising our 2026 sales growth guidance to high single-digit growth from mid- to high single-digit growth. I'll now hand over to Julie.

Thank you, Deborah. And I will now cover financial performance. So turning to the next slide. Starting with the core income statement for the quarter with all commentary at CER. Sales grew 5% and gross margin improved 250 basis points due to product mix benefits driven by the growth of specialty and vaccines, together with supply chain optimization charges that we took in Q2 last year. SG&A grew 5%, driven by launch investments and phasing compared with the prior period, partially offset by continued productivity gains. R&D growth in double digits continues to be driven by accelerated investment in the pipeline with 3 Phase IIIs initiated across specialty in half 1. And the royalties decline simply reflects the RSV IP settlement that we received last year. Operating profit grew 7% and EPS 9%, benefiting from a lower tax rate of 17.9% and the benefits of the share buyback. And then turning to the total P&L. Results were impacted by the impairment of Camlipixant following the recent CALM-2 readout. Now turning to the first half cash flow. CGFO was GBP 4.3 billion, up GBP 0.5 billion versus last year, driven by operating profit, receivables and the CureVac settlement income. Free cash flow improved by GBP 1 billion with around half driven by the business and around half driven by one-off cash receipts relating to linerixibat and ViiV. On the 15th of July, we completed the acquisition of Nuvalent at a net cost of GBP 7.1 billion, increasing net debt to GBP 22 billion, just under 2x net debt to 2025 core EBITDA. And the share buyback is now complete with an average price of GBP 16.13 over the 18 months. Now turning to guidance. I will now cover 2026. And at the end of the event, I will cover the longer-term outlooks. So following the strong start to the year, we are pleased to be updating our sales and operating profit guidance towards the upper half of the range. Sales by product area has been modified with HIV and vaccines expectations improving to reflect the strong performance of Cabenuva and also Shingrix, respectively. GenMed is downgraded to reflect the tough environment together with generic competition. Operating profit reflects the underlying strong business performance and is now expected to be in the upper half of the range with reduced SG&A and improved royalties, partially offset by increased R&D investments. EPS is now expected to be in the lower half of the range, and this is predominantly due to the additional interest of around GBP 160 million following the acquisition of Nuvalent. Now to support your modeling with respect to phasing, we expect operating profit growth to be significantly Q4 weighted. And a number of factors lead to this, including productivity charges taken in Q4 last year, whilst Q3 is impacted by the consolidation and phasing of Nuvalent costs and the acquisition-related interest together with a tough tax comparator. Thanks. And with that, I will hand back to Luke.

Thanks, Julie. Right. So coming back to the agenda, we'll now move to the accelerate portion of our event. As a reminder, we have allocated time for your questions halfway through and then again at the end of the presentations. At the start I mentioned the focus today is products and growth, and we'd now like to take you through our plan to do this. First, we'll give you more details on our products and why we're confident in our ability to grow the business. Second, we'll update you on how our late-stage pipeline is evolving. We'll also talk about what we're doing to accelerate and expand our key late-stage assets and about our work to improve our ability to find and develop new competitive products. Finally, we'll update you on how we are funding all of this. Essentially, we will be reallocating capital and resources in a disciplined way to focus on what creates value. Hopefully at the end you'll have the same confidence that the team and I have in our plan and our ability to execute it. Next slide, please. So what do we think our business is going to look like over time? Over the last few years, we have delivered considerable strong growth with commercial execution, and we will work very hard to maintain that growth in the near term while we invest in the late-stage pipeline. In the midterm, we've identified key growth drivers. We think those growth drivers will compensate for the loss of dolutegravir exclusivity and allow us to push through this transition period. In the longer term, the changes we're making now to how we operate will accelerate the next wave of products to continue delivering top-line growth. And finally, we remain very active in business development. Here, we're looking for incremental growth opportunities that make strategic sense for GSK. Next slide, please. The biopharma business has changed over the last 10 years. Operational execution has driven a move from being a company that was highly reliant on a genericizing business of largely primary care products and commoditized vaccines to a growth-oriented company with a broad mix of innovative products. Looking to 2031 and beyond, GSK will continue to evolve to be more specialty focused, and that means a much larger proportion of our sales coming from oncology, respiratory and hepatology, supported by a differentiated long-acting HIV portfolio. Right now our portfolio is built around five core therapy areas. Today, our team will engage with you about the promising potential we see in each of these areas. These are the five areas we're investing in and focusing on. Whether they're walking into a lab, a manufacturing site, one of our offices, or meeting our customers, every single one of our people needs to know how their role helps us deliver on these priority areas. In our business, and certainly with this audience, you'll understand this: a company's valuation is based on products and the core ability of management to recognize and deliver competitive innovation. To do that, senior managers have to be close to the products and the people leading the project teams. So we've taken material steps with the late-stage portfolio, business development and advancing our early stage to ensure that we are evolving to do just that. I'll cover the mid and early parts of this shortly, but starting with the late stage: every two weeks a subset of the Executive Committee, including Tony and Nina as well as other members, and Mondher who is on holiday right now, meet to look at the progress of our late-stage portfolio and selected assets. These meetings are led by the product teams, the people running the projects. This allows us to delayer the organization and promotes accountability. The aim is to keep us all on top of the internal and, critically, the external factors that influence our success. Since these reviews were started in January, we have identified acceleration opportunities across seven assets, 18 indications and 25 studies. You'll learn more about all of this today. As a result of these efforts by our team, we have over 20 Phase III starts this year, which is more than double the expectations we set out at the start of the year when we committed to 10. There is a good spread across our therapy areas and you can also see the increasing importance of oncology. These Phase III trials are based on validated data with strong medicine profiles. Each opportunity has been thoroughly interrogated as part of the strategic portfolio review process to give us the confidence to invest right now. This is a busy slide, but it does a good job of showing how these elements come together in terms of the late-stage portfolio, the momentum we have and the bolus we've built up in Phase III starts. There will be attrition after, because we are talking about drug development, but that's why we have a broad portfolio. Our portfolio really is a set of assets that we are confident are competitive and can drive growth. For the mid-stage portfolio, we will continue to supplement our pipeline with business development and we'll focus on products that address a validated target and where there is an efficacy or tolerability gap. So far this year, we have executed three deals. Looking at this list, we missed with Bellus and Camlipixant in cough, but we've just got approval with Jideytro in lung. Overall, the majority of assets we've acquired with these deals have progressed to Phase III. Next slide, please. In the early stage, we need to improve our output and we have to keep evolving how we work and who we work with. This slide shows we're putting our money where our mouth is. This is why we're closing Stevenage and moving our people up to Cambridge. Having lived and worked in Cambridge previously, I know the power of relocating to this environment. It is designed to help Tony and his team drive change and to make us fundamentally better at discovering and developing new drugs. Tony is going to take you through this in depth shortly. So how are we making all of this happen and how are we paying for it? To realize the opportunities in the late-stage portfolio and R&D, we have announced today an accelerate growth program. This program is about reallocation within our existing P&L to fund these studies and labs. This is a three-year program that will enable us to increase investment in R&D by targeting annual cost savings of GBP 1.9 billion by 2029. To do that, we will incur an expected one-time cost of GBP 2.4 billion, of which GBP 2.1 billion will be in cash. The majority of these savings will be reallocated to the late-stage pipeline and some of that money will also go towards strengthening the margin through the dolutegravir loss of exclusivity period between 2028 and 2030. This is fundamental to our strategy. We plan to evolve the company's cost base in line with its shifting product portfolio and to deliver accelerated long-term growth and value to both patients and our shareholders. Next slide. Finally, this is how we see the late-stage portfolio. The portfolio will evolve over time, accelerating growth to drive long-term value for patients and shareholders. With that, let's get into the nuts and bolts of how we're going to make this happen as a team. To get that started, it gives me enormous pleasure to hand over to Tony. Tony? There is additional interest of around GBP 160 million following the acquisition of Nuvalent. To support your modeling with respect to phasing, we expect operating profit growth to be significantly Q4 weighted. A number of factors lead to this, including productivity charges taken in Q4 last year, while Q3 is impacted by the consolidation and phasing of Nuvalent costs and the acquisition-related interest together with a tough tax comparator. Thanks. And with that, I will hand back to Luke.

Hi, everyone. Delighted to be here with you, and thanks, Luke. As Luke highlighted earlier, accelerating R&D is a key priority for us, and this means focusing on 3 important areas: maximizing the value of the late-stage portfolio, supplementing that portfolio through business development and of course, accelerating the progress we've been making in changing the way we work in R&D. I'm pleased with the progress we've already made. Starting on the left-hand side of this slide, you can see the value of our pipeline is increasing. In fact, we've more than doubled the number of Phase II and Phase III assets with blockbuster potential since 2022. Our pipeline is also moving 25% faster, meaning we're now in the upper quartile of our peers based on recent CMR benchmarks. We expect this trend to continue to improve. Together, this means we can do more. And as you can see, we significantly increased the number of Phase III starts this year compared to the past. 2026 will be a bolus year for Phase III starts based on our acceleration decisions, which I'll cover in more detail in a moment. Much of this has been achieved through our use of data and technology. It enables faster decision-making with greater confidence, something we continue to embed in all aspects of R&D. As Luke mentioned, we're taking a new approach to reviewing the portfolio. And this means experts from project teams present directly to myself, Luke and Nina, so we can make quick decisions, resolve issues promptly and provide support to advance exciting programs. The approach ensures we have the right alignment across R&D, commercial and medical to make the most informed decisions possible. It's fully cross-functional, data-driven and has already allowed us to confidently make a number of acceleration decisions, which you can see on the right-hand side of this slide. These are the assets and programs you'll be hearing more about today, so you can understand why we're excited about them based on their differentiation and potential benefit to patients. In oncology, our ADC portfolio has been significantly accelerated. This is supported by data from our partner, Hansoh as well as our own global clinical program. Our decision to accelerate 5 Phase III studies for Mo-rez in gynecological tumors and 4 for Ris-rez in lung and prostate cancer demonstrates our confidence in these assets. In respiratory, we'll start 6 Phase III trials across indications for our ultra-long-acting TSLP GSK'283. This is a significant acceleration of its development path. Kaivan will describe emerging data, which support the use of the 6-monthly regimen for treatment of diseases like COPD. For efimosfermin data suggests a best-in-class profile for the treatment of MASH. The program has recently been accelerated against our original timelines and now includes F4 in addition to F2 and F3 patients. And I'm pleased to announce that the F4 program recruited its first patient only last week. As you can see on this slide, the changes we've been making in R&D, particularly in development have led to a transformation in our late-stage portfolio, which is now much more focused in areas with greater patient benefit and value. Overall, we're significantly increasing the number of Phase III starts significantly this year. We expect this trend to continue to be above what it was in the past, although not at the level we're seeing this year. Importantly, these are in high-value areas with a major driver of this being a significant increase in the number of oncology Phase III studies. 2026 will see the start of pivotal trials for Mo-rez in gynecological cancers, Ris-rez in genitourinary cancers, Velzatinib in first-line GIST, efimosfermin in F4 MASH and our 3x yearly treatment for HIV. External innovation and business development have been and will continue to be an important part of accelerating R&D. Luke highlighted the deals we've added. We'll continue our approach of bringing in assets with validated targets that address efficacy or tolerability gaps to complement our mid-stage pipeline. We use the same data-driven, scientifically courageous approach I just described for our BD decisions as well. It's true for both clinical and earlier platform deals. And in the latter case, it means R&D is increasingly externally focused. You'll hear more from me on the early-stage R&D later in the year. Now as we become more externally focused, we're also making sure we co-locate our key laboratories with major external innovation hubs containing leading academic institutes. We have 4 key locations, the East Coast of the U.S., U.K., Europe and China, each with important academic partnerships. The partnerships span a portfolio of interests aligned to our core therapeutic areas and forge deep connections with leading researchers that expose us to groundbreaking innovation. The majority of these projects focus on human health data, giving us unique insights that de-risk our target identification and translational efforts and allow us to advance faster with greater confidence. We continue to actively look to expand our partnerships on the East Coast of America and in China, and I look forward to sharing updates with you in the future. In Europe, we already have a significant presence with very strong partnerships like the one we have with Oxford University. The announcement today that we're establishing a hub in Cambridge, U.K. shows our commitment to ensuring our people are in the right places with the right partners to accelerate innovation. Our new Cambridge site will accelerate the changes we're making within R&D, reflecting the new way of working we've built to discover and develop medicines. CBC is one of the leading integrated biomedical campuses in the world and as such is a perfect location for us. We'll be beside one of our key academic partners, Cambridge University as well as with internationally recognized research hospitals and clinical infrastructure. Our scientists will be able to work in state-of-the-art technology-enabled labs with an ecosystem of innovative AI and biotech companies. This move is part of a broader transformation of R&D, which I'll continue to update you on. Finally, I want to reiterate the strength of our late-stage portfolio, which has been delivered from the momentum we've been building over the past years through business development and most recently, our acceleration decisions. We have a number of exciting milestones ahead of us, and I look forward to updating you on these in the future. With that in mind, I'm now going to hand over to the team to take you through these programs in more detail, and we're starting with Hesham and our oncology portfolio.

Thank you, Tony, and good afternoon, everyone. I'm Hesham Abdullah, Global Head of Oncology R&D at GSK. Today, I'll highlight the significant progress we've made in oncology, building on our strength in gynecological and hematological cancers and expanding into new tumor types. Given the additional R&D investment we're announcing today, I'll also discuss how we'll focus this investment to accelerate development and bring our pipeline of clinically meaningful medicines to patients faster. Let's start with why oncology matters. Oncology is a large market opportunity, defined by significant and persistent unmet need. Cancer incidence continues to rise with many tumor types projected to see double-digit growth in incidents through 2030 and beyond. Despite meaningful advances over the past decade, driven by precision medicine and new modalities, many cancer diagnoses continue to have very low 5-year survival rates. There remains a substantial opportunity to improve patient outcomes. Our pipeline and team are well positioned to address this growing unmet need. We've built a portfolio of competitive, high-potential assets and critically, we have a talented team with a proven track record of execution in oncology. This combination of high unmet need, a high potential portfolio and a proven team will make oncology a key growth driver for GSK. We've been deliberate with how we've rebuilt the oncology pipeline at GSK, starting with strong franchises in hematology and gynecologic malignancies and now expanding into lung cancer, propelled by the recent Nuvalent acquisition as well as gastrointestinal, prostate cancer and other solid tumors. Building on our marketed anchor assets, we're advancing a deep clinical stage pipeline across multiple modalities, including ADCs, next-generation targeted small molecules, immune cell engagers and novel precision oncology medicines. We're focusing on developing a better understanding of cancer biology, generating unique insights from deep phenotyping, novel nonclinical model systems and foundational models for patient identification and stratification. These differentiated oncology technologies enable sustained growth and innovation with a quality portfolio of assets in our research pipeline. End-to-end, our GSK oncology portfolio is designed for scale and sustained leadership. Turning first to our 2 lead antibody drug conjugates, Mo-rez and Ris-rez. Both ADCs utilize a proprietary TOPO1 payload with a proven linker technology designed to deliver enhanced stability and tumor penetration with a potentially differentiated safety profile. For example, in our BEHOLD interim study results presented at SGO, we observed a 3% incidence of ILD pneumonitis, and we'll share further evidence of these potentially differentiated outcomes at ESMO with Ris-rez. We've already advanced both ADCs into pivotal programs based on an extensive range of clinical data spanning across ovarian, endometrial, small cell and prostate cancer with data generation ongoing across other solid tumors. Early access to extensive Hansoh clinical data sets in large patient populations, combined with competitor insights and our own data in global populations allows us to rapidly incorporate learnings, design competitive Phase III trials and optimize our strategic positioning. At the same time, we're evaluating novel biomarkers to potentially further enhance activity with a multipronged translational strategy. Across both programs, we're delivering at pace, striving for flawless execution while making smart, disciplined choices along the way. Mo-rez (mocertatug rezetecan) builds on the strong foundation of ZEJULA and Jemperli to drive GSK's next wave of innovation in gynecologic cancers. Strong clinical data in both ovarian and endometrial cancer position Mo-rez in the top tier of a competitive and emerging class of antibody drug conjugates in gynecologic malignancies. Mo-rez delivered numerically higher antitumor activity, combined with manageable safety with a 62% response rate in platinum-resistant ovarian cancer and a 67% response rate in second-line plus endometrial cancer. Importantly, this activity is independent of B7-H4 expression level with no unique toxicities. For example, none of the TROP-2-specific stomatitis. Supported by an extensive data set, we've moved at pace to initiate a scaled Phase III development program, initiating 5 Phase III studies during 2026, including 3 ovarian and 2 endometrial cancer studies. Driven by a strong signal observed with Mo-rez in early clinical trials, the BEHOLD clinical program has recruited over 600 patients, and it has taken just 15 months to move from Phase Ib to initiating Phase III. Expect further safety and efficacy data updates from Mo-rez at ESMO. The second asset from this class-leading ADC platform is Ris-rez, our B7-H3 ADC, which is effectively an oncology pipeline in a single asset. B7-H3 is widely expressed across a large number of solid tumors. Across these potential indications, we're prioritizing early entry into small cell lung cancer and prostate cancer, where proof of concept has already been established. In parallel, signal confirmation in a global population is underway in non-small cell lung cancer and sarcoma, now that proof of concept has been established in China. And we're also exploring additional opportunities across multiple other solid tumors. With already more than 930 patients dosed across both trials globally, we have established a strong foundation to further accelerate Ris-rez development and maximize its potential. Similar to Mo-rez, robust early clinical data provides conviction to move our Ris-rez program with pace and at scale. In the second-line small cell lung cancer setting, the FDA granted Ris-rez breakthrough therapy designation based on the initial data presented by Hansoh at the World Conference on Lung Cancer in 2024. The updated data published in Cancer Cell this year showed an objective response rate of 60% with a 6.3-month median progression-free survival and a 14.9-month median overall survival in the TOPO-1 naive cohort. Earlier in July, our partner, Hansoh, announced that Artemis-008, a Phase III China study, met its primary endpoint, demonstrating a clinically meaningful and statistically significant improvement in overall survival for patients with second-line small cell lung cancer. This marks a significant milestone as the first positive Phase III overall survival data for a B7-H3-directed ADC in any tumor type. Our global GSK Phase III study in second-line plus small cell lung cancer 301 is actively recruiting, and we plan to initiate a first-line study later this year. And at China non-squamous non-small cell lung cancer, second-line plus population, Ris-rez has demonstrated meaningful activity, both as a monotherapy and in combination with a PD-L1 inhibitor. Our ongoing Phase II combo study EMBOLD PanTumor-101 will aim to confirm the signal in PD-1 exposed patients in a global population. Prostate cancer is a key growth opportunity for Ris-rez, and we will initiate a number of Phase III studies in prostate cancer before the end of the year. The EMBOLD program includes 2 Phase III monotherapy studies in late-line and chemo-naive metastatic castrate-resistant prostate cancer as well as a Phase III combination study in metastatic hormone-sensitive prostate cancer. These accelerated investments are supported by the response data shown here on the left, a 37% confirmed objective response rate in metastatic castrate-resistant prostate cancer patients, supported by 9 months landmark PFS rate of 56%. Ris-rez is complemented by a growing pipeline of early-stage prostate assets that position us for future expansion with different modalities. Highlights for the remainder of 2026 include the Artemis-008 data set, which looks like Ris-rez in second-line treatment of small cell lung cancer. This trial met the overall survival primary endpoint and data will be published before the end of the year. These data are significant because this is the first pivotal trial to show a survival benefit for any B7-H3-directed ADC in any indication. In addition, our partner, Hansoh, has just announced positive results from a second China Phase III study, evaluating Ris-rez in osteosarcoma patients that have received at least 2 prior lines of therapy. The trial demonstrated a clinically meaningful and statistically significant improvement in its primary endpoint, IRC-assessed PFS with consistent benefit observed in key secondary endpoints. Osteosarcoma is an area of high unmet need, and Ris-rez has secured breakthrough therapy designation from FDA in this tumor type. Data from the Phase III study will be presented at a scientific congress later this year. Additionally, at ESMO, we'll share the first Ris-rez data from a global population alongside ILD analyses that will further characterize the asset's potential differentiated monotherapy safety profile. This momentum is expected to continue into 2027 with Ris-rez data being presented at major medical congresses throughout the year. Together, this represents a rich multiyear data cadence across one of the broadest B7-H3 development programs. Turning to our recent Nuvalent acquisition, which provides assets in precision oncology lung cancer. Neladalkib and Jideytro have the potential to transform treatment in ALK-positive and ROS1-positive non-small cell lung cancer. The potential to improve efficacy and tolerability in ALK-positive and ROS1 positive patient segments will support extended treatment duration and in turn, drive market growth. The ALK and ROS segments of the non-small cell lung cancer market represent around 2% to 4% of the overall population. But these segments are typically younger, they are more frequently women and fitter than the broader lung cancer population. Patients are usually diagnosed with metastatic disease and typically have a higher rate of CNS involvement at diagnosis. For patients with ALK/ROS1 non-small cell lung cancer, next-generation agents like Jideytro and Neladalkib may extend median PFS beyond 46 months in ROS1-positive patients and over 84 months in ALK-positive non-small cell lung cancer patients. While the majority of first-line lung cancer patients will be treated for around 9 to 10 months, the duration of therapy for a first-line ALK patient may be greater than 7 years. Jideytro was recently approved by FDA for the second-line treatment of ROS1-positive non-small cell lung cancer patients. We're also working with FDA to support Neladalkib approval with an FDA decision for second-line ALK-positive non-small cell lung cancer expected by November 27. First-line studies for both Jideytro and Neladalkib are still ongoing and enrollment in Neladalkib's first-line ALKAZAR Phase III trial is already more than 30% complete. In the cross-trial comparison shown here for ALK-positive non-small cell lung cancer post second-generation TKI, Neladalkib shows 14.5 months median PFS compared with 6.6 months achieved with lorlatinib, with 91% of patients maintaining a response for more than 12 months versus 70% with lorlatinib in a TKI-naive population. In ROS1-positive non-small cell lung cancer post TKI, Jideytro shows 23.8 months median PFS compared with 9.7 months for taletrectinib with 96% of patients maintaining a response for more than 12 months versus 74% for taletrectinib in a TKI-naive population. Acknowledging the caveats that exist with these cross-study comparisons, these data appear to suggest the potential to meaningfully prolong median PFS with Neladalkib and Jideytro. These are best-in-class efficacy profiles, and I will review safety and tolerability data on the next slide. Data from the Neladalkib clinical program indicate Neladalkib is well tolerated with the lowest rates of dose reductions and discontinuation when compared with other assets in the class. Neladalkib is a highly selective ALK inhibitor, which is reflected in the adverse event profile observed in clinical studies. Neladalkib does not appear to be associated with the long-term metabolic and neurological adverse events seen with other TKIs in the class. While Neladalkib does show higher liver enzyme elevations, physicians' feedback indicates these are largely clinically asymptomatic and manageable with routine monitoring. In short, a tolerability profile designed for long-term first-line use. Velzatinib is another asset in our precision targeted therapy portfolio. It's in Phase III development for the treatment of GIST or gastrointestinal stromal tumors, a rare type of cancer, which develops in the digestive tract, most commonly in the stomach or small intestine. The first-line standard of care for GIST patients has not changed since the introduction of imatinib over 20 years ago. While this first-line therapy has improved the outlook for patients over time, GIST tumors will ultimately become resistant to imatinib and patients typically progress to a second-line treatment strategy. The standard of care in second-line treatment is not well tolerated with variable efficacy. Velzatinib is the only agent in the TKI landscape, which targets all primary and key secondary KIT mutations with a lower rate of adverse events when compared to other available treatment options or standard of care. At ASCO this year, we presented velzatinib data, which showed a 61% confirmed response rate and a 65% unconfirmed response rate for velzatinib in the first-line setting with every patient on the trial demonstrating a reduction in tumor volume. These data were used to inform the StrateGIST frontline study, which recently started recruitment. We now have 2 Phase III studies underway, StrateGIST-3 in second-line GIST and StrateGIST frontline in first-line GIST, both exploring velzatinib as monotherapy. Recruitment for both studies is progressing strongly ahead of schedule. This momentum underscores the pace at which we're advancing this asset and velzatinib's potential to redefine the standard of care in GIST. Finally, I'd like to provide a short update on Blenrep, our ADC for the treatment of multiple myeloma. Blenrep's clinical development program is targeting all patient segments of newly diagnosed multiple myeloma. The DREAMM-10 study is designed to investigate a Blenrep combination, which is appropriate for the majority of first-line or newly diagnosed patients. These patients are described as either standard risk fit or high-risk frail patients. DREAMM-10 investigates a Blenrep triplet versus a daratumumab triplet, and we anticipate preliminary MRD negativity data in the first half of 2028. For high-risk non-frail newly diagnosed patients, the Phase III PRECOX study will investigate a quad regimen of Blenrep plus VRd versus a CD38 combination of daratumumab plus VRd in a high-risk enriched population, addressing the need for deeper myeloma control through higher treatment intensity. Together, these 2 pivotal studies should support blenrep use in a large proportion of the first-line multiple myeloma patients. Blenrep's projected median progression-free survival of 101.8 months from the TERPOS data presented at EMN is competitive versus 100 months for a CD38 quadruplet regimen and 62 months from a CD38 triplet. Next, real-life burden of care. BRd offers a meaningfully lower burden of care with dramatically fewer infusion days. This has real-world implications for patients. And then finally, the Grade 3/4 ocular event rate is significantly improved and matches first-line expectations. This is achieved with 1.9 mg per kg dosing on a once every 12-week dosing schedule in the maintenance setting. This is a regimen designed to optimize benefit-risk in this newly diagnosed patient population. Now let me close with the big picture. Our GSK pipeline and team are well positioned to address the growing unmet needs in oncology. We have a highly competitive oncology pipeline, and we're continuing to apply various acceleration levers. Starting in lung, we have a near-term acceleration opportunity into second line with Jideytro now approved and Neladalkib on its heels with first-line expansion for Jideytro planned in first half 2027. Both address clear efficacy and tolerability gaps. With our 2 ADCs, extensive clinical data sets provide conviction to progress multiple pivotal programs at pace with Mo-rez in gynecologic oncology and Ris-rez being a pipeline in a single asset. Ris-rez brings the first positive Phase III OS data for any B7-H3 directed ADC with 2 positive Phase III trials to be presented in the second half of 2026. Continuing with our pipeline of differentiated precision oncology medicines in areas of unmet need, Velzatinib has the potential to redefine a 2-decade-old standard of care for GIST patients as a well-tolerated monotherapy with potential superior activity and tolerability profile. Finally, we will continue to see upside with Blenrep. The ongoing clinical development and evidence generation program aims to ensure success in newly diagnosed patients while creating broad access for community-based BCMA therapy. Taken together, this is a high potential competitive oncology pipeline and one we're advancing with real pace and conviction. I'll now hand it back to Luke to commence the Q&A session. If I can also ask Julie, Nina, Deborah and Tony to join me on the stage as well.

So welcome back, and I now get to introduce Kaivan, over to you.

Thanks, Luke. Good afternoon, everyone. My name is Kaivan Khavandi. I'm the Head of R&D at GSK for Respiratory, Immunology and Inflammation. GSK is well recognized as the leader in respiratory medicine, having pioneered multiple products across indications, notably asthma and most recently with the launch of Exdensur, the first ultra-long-acting biologic to be launched in airways disease. However, when we think about the largest remaining unmet need and the sheer scale of opportunity, this is undoubtedly in COPD, which is an area of enduring growth and represents a core focus of our future portfolio. Similarly, in hepatology, we have an important product launch planned with bepirovirsen for chronic hepatitis B, a rare opportunity to impact population health and where, of course, we're committed to realizing the full breadth and value of that product through its life cycle, including potential combinations. But it's steatotic liver disease, secondary to MASH and alcohol, where we see GSK continuing to innovate with efimosfermin and beyond. What's underappreciated, though, is that these 2 areas are much more connected than at first apparent — serious chronic diseases with shared underlying inflammatory and fibrotic as well as vascular risk, which frequently coexist. Patients with primary disease of the liver, heart and lung are also at risk of developing secondary pulmonary hypertension, a serious and much more expansive area than idiopathic pulmonary arterial hypertension, for which there is largely no approved treatments. Together, these 3 areas form an unaddressed comorbidity cluster that carries a very high risk of mortality and for which GSK is strongly positioned to lead. So with that background, when we look at recent product developments at GSK, success has been demonstrated really as a consequence of mechanisms that stop the core inflammatory risk relevant to each disease. In areas like asthma and nasal polyps, these are primarily driven by T2 pathways identified by eosinophils and very well served with products like Nucala. Future innovation in these diseases will not come from marginal gains with new mechanisms, but from practical real-world innovation from modalities that can help patients comply and persist on their medicines, enter our ultra-long-acting portfolio with Exdensur and ultra-long-acting TSLP. There is one overlooked T2-driven disease, and that's food allergy, where IgE targeting has only recently been shown to be effective and where we rapidly build on that observation and early commercial success with an improved long-acting and potentially best-in-class approach with Ozareprevast. And that takes us to COPD and non-CF bronchiectasis. Whilst an important subset of COPD is T2-driven, most of it is not and a different set of risk factors with distinct inflammatory, metabolic and vascular drivers are responsible for disease progression. Here, we do need mechanistic innovation, and we apply our deep translational insights directly to late-stage product developments, notably with IL-33. This bridges us to pulmonary hypertension that can, of course, result directly as a consequence of COPD, but is a pulmonary vascular disease by definition with mechanisms of risk overlapping with COPD on the left and MASH on the right. So with COPD really at the center in terms of the greatest burden of disease, GSK's competitive advantage in bridging these 2 worlds of inflammatory risk, let's take a moment to consider the scale of the problem. And it's substantial. You might have heard these stats before, but when you see them contrasted versus enormous established markets like rheumatology, it becomes evident that we're only scratching the surface with only 2 advanced therapies in one subtype of COPD reserved for late-stage disease. But with 400 million patients affected globally, over 20x more patients than rheumatoid arthritis and 100x more deaths annually, it becomes very clear that multiple product solutions are needed. So what do things look like for a patient with asthma or COPD today? The orange line in the top figure shows exacerbations and with them, the step changes in lung dysfunction, which in asthma leads to disease progression and in COPD brings irreversible loss of lung. And as seen in the red line below, these are associated with surges in mortality. Short-acting biologics today are started late with poor persistence leading to disease progression in asthma and unfortunately, hospitalizations and premature mortality in COPD. So what's the solution? Well, start biologics sooner and stay on them for longer. If we were able to move from 24 injections a year to just 2 and provide sustained coverage and protection, that would surely be the way to achieve this. And that's precisely what our portfolio is designed to do with Exdensur launched in asthma and shown in the graph, how we're approaching COPD, a development program that seeks to sustain persistence, but not just at the conventional point of treatment, but with these unique characteristics of the medicine, we have the confidence to start a third Phase III study, VIGILANCE, enrolling patients after just 1 exacerbation. That's unprecedented for a biologic. So the prior slide showed how Exdensur achieves greater coverage and clinical benefit in patients with T2 inflammation through earlier management, and that's illustrated in the rubric here by extending across the grid horizontally. But I mentioned that in COPD, we do need more mechanistic innovation to achieve greater coverage across different populations who have different types of inflammation, and that's illustrated by extending vertically up the grid. Nucala was the first biologic to achieve a broader label owing to metrics, which studied lower eosinophil levels, while MATINEE showed efficacy for the most clinically impactful events, emergency department visits. TSLP is a mechanism that by design is able to extend into intermediate T2 inflammation and where data indicates efficacy in those with eosinophils as low as 150 but not lower. And that takes us to IL-33, where we probably need to ignore eosinophils altogether as this mechanism cuts COPD in a fundamentally different way, and that's easier to visualize. All patients with COPD have innate immune dysfunction and a propensity to T1 and T17 inflammation. These patients are older than those with asthma, they're sicker and they have a high burden of vascular and metabolic disease represented on the right-hand side of the slide. A proportion of these patients have truly high T2 risk and a further group have mixed intermediate levels. This is the orange and middle overlap segments of the slide. And this risk is well addressed with IL-5 and TSLP biologics, respectively. But how do we get to the backbone of pathobiology in COPD, the blue plane in the slide? Well, a single, dual or even triple cytokine approach won't be the answer if they're targeting the wrong biology. This is where we need to get to the tissue, vascular and structural damage that results from repeat injury at the root of COPD. IL-33 is expressed primarily on lung epithelial and vascular endothelial cells, the dynamic barrier lining the airways and blood vessels. These are the first tissues to be exposed to and then attempt to respond to inflammatory injury and our translational insights reveal how and when IL-33 governs this therapeutically untapped space. And so we're very excited to have a potentially best-in-class long-acting and Phase III-ready product, which will be deployed with the benefits of this deeper understanding. We predicted the early success now shown clinically for anti-IL-33 when stratifying based on mucus score. With the luxury of what we believe to be the most complete set of respiratory data anywhere in the world, over 1,000 randomized controlled trials, several million patients with deep genetic and cellular profiling and of course, clinical interventional data in COPD with our product, we've designed pivotal studies based on patient profiles most likely to respond to IL-33. These will include factors related to stage of disease by which I mean lung function, distinct from disease severity defined by exacerbation history and other traits and tested against new clinically important outcomes that can differentiate the product. Without disclosing too much, what I can share is that one of these pivotal study starts includes a cardiorespiratory outcome study, which we will start next year in partnership with a major cardiovascular academic research organization. In parallel, we will complete our Phase II study in non-CF bronchiectasis, an enormous market with no approved biologics and where we're positioned to be best-in-class with IL-33 as well as testing combinations with TSLP, which our AI-enhanced models predict could provide synergistic efficacy. So we're looking forward to coming out of IL-33 stealth with conviction and material differentiation. Our ultra-long-acting TSLP program has been significantly accelerated by 9 months across 3 indications, now positioning this asset to start 6 pivotal Phase III studies, the PERSIST program integrating data from a GSK-sponsored Phase II study in asthma, the NASER study, alongside data from our partner, Hengrui, who studied nasal polyps. This gives us dosing and pharmacodynamic data to confidently advance the first ultra-long-acting TSLP across all major indications, asthma, nasal polyps and COPD. Our BD strategy to access de-risked mechanisms with a high likelihood of success allows us to jump directly to testing for product differentiation rather than mechanistic relevance. And this is reflected in our deal activity since January. Ozarepubart builds on the proven efficacy of IgE in food allergy and chronic spontaneous urticaria, but provides materially broader eligibility for those 25% of patients contraindicated for omalizumab because of their weight or high IgE levels and an optimized solution for all with 3 monthly dosing. This will be transformative for the prevalent adolescent population and children. This class has had a remarkable first launch within the first 2 years with omalizumab, now Roche's fastest-growing product and Ozarepubart is positioned to provide an objectively improved profile whilst benefiting from that momentum. This overlooked space has understandably garnered interest and activity since our deal, but Ozarepubart is the most advanced next-generation product with clinical efficacy data in chronic spontaneous urticaria, which importantly included an active arm with omalizumab, which didn't perform as well as Ozarepubart. The program is rapidly enrolled in Phase II and has now recruited the sample size necessary to progress to an interim analysis, which will enable Phase III start in both food allergy and chronic spontaneous urticaria by the end of 2027. For HS235, we build on a new and transformative class of activin traps in pulmonary arterial hypertension, but with an improved molecule that can both remove the liabilities of the incumbents in group 1 pulmonary hypertension, namely bleeding, but what's equally exciting is the potential to unlock the full value of the mechanism, which extends to reducing inflammation, insulin resistance and reducing visceral fat, all of which are substantial drivers of risk in Group II and Group III pulmonary hypertension secondary to chronic heart and lung disease. Whilst this program is relatively earlier than other products being presented, we've seen evidence to support both the safety and efficacy profile described in the Phase Ib study. And I can share today that we've rapidly converted this post deal to Phase IIb starts that have now been initiated for both Group 1 and Group 2 pulmonary hypertension. And that takes us to our hepatology portfolio. Put succinctly, our portfolio is pointed to the 3 major causes of liver-related cirrhosis and mortality, chronic hepatitis B, metabolic dysfunction-associated steatohepatitis and alcohol-related liver disease. All of these diseases have poor outcomes and inadequate standard of care. There's no approved treatments for alcohol-related liver disease, one liver-directed treatment for MASH and no therapies that can drive cure in hepatitis B. Let me start with bepirovirsen, our first-in-class ASO for hepatitis B. Our program was ambitious, designed with the primary endpoint of functional cure, the very highest bar. This is best illustrated in the comparator arm in B-WELL, where what's labeled as placebo actually represents the standard of care, 48 weeks of treatment with a nucleoside or nucleotide analog. And in that group, we saw 0 patients achieved the primary endpoint, functional cure in the ITT population. 0 patients achieved functional cure in those with baseline surface antigen levels less than 1,000 and 0 patients achieved an effect with surface antigen levels under 100, which will be consistent with the definition of partial cure. In comparison, bepirovirsen achieved 19% cure in the ITT population, 26% in those with surface antigen at baseline less than 1,000. And importantly, when you include partial cure, a response that's been reported in population studies to improve long-term outcomes, almost 1 in 2 patients studied in the ITT population received a response that would predict clinical benefits. And that increases to 62% in those with surface antigen levels less than 1,000 at baseline. Of note, this opportunity consolidates in 3 key markets: China, U.S. and Japan. You can see the epic scale of the opportunity which is vast. So a very exciting opportunity reflected in a suite of expedited regulatory designations setting up near-term expected marketing authorizations and product launches. And then efimosfermin, our potentially best-in-class FGF21 analog in an area of major unmet need in steatotic liver disease. Let's start with the class. On the left, in F2-F3 MASH, you can see greater benefit on improvements in fibrosis with FGF21 analogs when compared indirectly across studies with GLP-1 agonists, such as semaglutide and thyroid hormone agonist, resmetirom. Moving to the right in cirrhotic MASH, where currently there's no approved treatments, you can see placebo adjusted changes that are unprecedented with this class, showing the ability to reverse histological fibrosis and move the patient from cirrhotic to non-cirrhotic disease. In contrast, semaglutide showed directionally worse effects versus placebo. And then within the class, we selected efimosfermin over other products, all available at the time of acquisition based on its best-in-class credentials with monthly versus weekly or biweekly dosing regimens. And since the deal, efimosfermin has reported the fastest observed signal for an antifibrotic benefit of any in the class with fibrosis biomarkers improving as soon as 4 weeks after treatment and for which we've designed our pivotal program to substantiate as a potential additional differentiator. For all these reasons, we're committed to realizing the full value of this potentially transformative product, seeing us initiate the ZENITH studies to F2/F3 MASH, both recruiting since earlier this year. And we have now initiated the F4 cirrhotic MASH program, the NEBULA studies only in the last 2 weeks. And our Phase II study in alcohol-related liver disease, ALL-STAR has just had IND approved and will start this year. So a portfolio of specialty products pointed to serious and prevalent diseases with renewed discipline to truly focus on areas of greatest commercial value and in turn, prioritize and accelerate those programs. Unprecedented data for bepirovirsen, which resets the bar of efficacy in chronic hepatitis B with functional and partial cure where the standard of care fails to achieve either. A portfolio in COPD that will provide modality and mechanistic innovation providing greater coverage and protection for a disease that's the third leading cause of death globally and with material acceleration of programs like ultra-long-acting TSLP and with both molecule and potential evidence and claims differentiation for our best-in-class long-acting IL-33. Efimosfermin advancing at speed across a comprehensive Phase III program, which will capture the unique breadth and potential for this mechanism across all stages and etiologies of steatotic liver disease, F2 and F3 MASH, cirrhotic F4 MASH, alcohol-related liver disease and actually potentially beyond with a molecule that has best-in-class properties. And a portfolio enhanced by BD deals that bring best-in-class products, de-risked mechanisms and which all fits within an axis of disease that physicians recognize that has yet to be applied to drug development. And that's a gap that GSK is uniquely positioned to address. With that, I will hand over to my colleague, Sanjay, to cover vaccines.

Thank you, Kaivan. Good afternoon, everyone. My name is Sanjay Gurunathan. I head the Global Vaccines and Infectious Disease Unit in R&D. Vaccines have a massive impact on public health. That's not new. We've known that for decades that preventing disease takes real pressure off health systems. But here's the thing. The science and economics around vaccines are shifting. They are pointing to something much bigger than we give them credit for. So let's dig into why this is the case. Here's a stat that always surprises people. Vaccines make up a tiny slice of our health care spending, less than 1% of the health care budget in high-income countries. And yet that investment's return on investment is roughly 19x of what you put in. We already know how valuable it is to prevent an infection. What's missing in the economics is the big picture. The benefits that go beyond preventing the disease a vaccine was designed to stop. And let's think about that. That could be worth a lot. But if it's not on the label, it doesn't count towards how a vaccine gets assessed or reimbursed. The science is starting to catch up. We used to think of an infection as something that happens and then passes. It turns out that's not the whole story. A lot of infections go dormant in the body, and some of them seem to be tied to long-term health effects, even chronic disease down the road. So preventing that initial infection might do a lot more than we thought. It could lower your risk of things like heart disease and dementia later in life. So the opportunity here is simple. We need to build the evidence that turns this potential into something that's recognized and reimbursed. And GSK is in a great spot to lead on this. We have already a broad, well-established vaccine portfolio, Shingrix, RSV, flu vaccines, a strong meningitis franchise and a deep lineup of pediatric and travel vaccines. But more importantly, there's real room to expand beyond what these vaccines can already achieve. Shingrix is our best example of this. We have a huge amount of real-world experience. Over 116 million adults have been vaccinated with Shingrix since it was launched nearly a decade ago. This growing body of evidence that herpes viruses, including herpes zoster, the virus that causes shingles can influence cognitive decline. So why would that be the case? Well, the shingles virus doesn't actually go away after a chickenpox infection. It just goes dormant hiding out in the neurons. When it wakes back up, it can start local inflammation, and that inflammation seems to play a role in cognitive decline over time. So by keeping the virus from reactivating in the first place, Shingrix may end up slowing down that decline. But there's likely more to the story. We think Shingrix's adjuvant AS01 might be doing some extra work behind the scenes beyond just blocking viral activation. It could possibly be dialing down inflammation more broadly, including the kind of age-related inflammation that builds up in the brain. If that's right, it could mean Shingrix is nudging the whole trajectory of neuroinflammation in a healthier direction. We've now seen through several observational studies, risk reductions of dementia symptoms up to 50%. This signal is now being put to test in 2 big pragmatic studies in Finland and Denmark, covering around 200,000 people with results expected from 2029. We're not only seeing this as how Shingrix affects neuroinflammation, but when we look at cardiovascular risk, it gets even more interesting on Shingrix's broader protective effects. Real-world data from several independent sources, Veterans Affairs, Kaiser, Optum, Truveta and others all point the same way. Older adults who got Shingrix saw about a 25% drop in major adverse cardiovascular events or MACE. So why should that be? It turns out the shingles virus itself isn't exactly harmless to your blood vessels. It can damage them, spur up inflammation and even trigger clotting, all of which nudge up your risk of stroke and heart attacks. We think Shingrix, thanks to our AS01 adjuvant, might also be doing some quiet work behind the scenes, calming inflammation and potentially bending the curve on chronic diseases in older adults. So what does this all mean? This matters a lot. Cardiovascular disease is expected to nearly double by 2050 with costs in the U.S. alone set to top over $400 billion a year. We believe the real-world evidence you're seeing is compelling enough that we are launching a formal Phase III randomized controlled trial this year to nail down whether this is actually causal, not just correlation. We expect the study to start soon. Another opportunity to improve outcomes in older adults is to prevent influenza infection. The disease burden of influenza is significant in older adults with the majority of hospitalizations occurring in older adults. It's a segment we have not previously competed in. We know from published literature that influenza vaccination reduces cardiovascular disease burden and respiratory complications, underpinning the theme of broadening the protective effects of vaccine, especially in older adults. As you can see, currently available flu vaccine effectiveness has varied from 20% to 60% over the past 15 flu seasons, illustrating why there's a true unmet need to improve flu vaccine effectiveness. We believe there's an opportunity using our mRNA technology to establish benefit over current standard of care. We can optimally leverage this technology, its differentiating characteristics to develop our next best-in-class flu vaccine. We will present our positive Phase II results at the Options meeting next month, where you'll hear the exciting data. So let me conclude. What's our focus and where is our focus? Our focus is expanding the role of vaccines in helping older adults live longer and healthier lives. If you can back that up with strong clinical outcome data and a real understanding of the biology behind it, it could support future labels that reflect these broader benefits. And that changes things. It gives health care professionals more confidence to recommend vaccination and gives more people reason to get vaccinated no matter what their current health status is. What really excites us is the growing signs connecting infection to chronic disease. It makes an already strong economic case for vaccination even stronger. Opens up new opportunities across our portfolio. And thanks to Shingrix, it gives us a real working example of how to unlock that value and help shift the trajectory of chronic diseases for older adults. It's now my pleasure to hand over to Charlotte, who will talk to you about our HIV business.

Thank you, Sanjay. I am Charlotte Allerton, Head of R&D and CSO for ViiV Healthcare at GSK. Despite decades of progress, HIV remains a major unmet public health challenge. More than 40 million people are living with HIV globally. And in the U.S., around 30% of people diagnosed with HIV are not virally suppressed, equating to approximately 400,000 people, the majority of whom are still taking daily oral antiretroviral medications as their standard of care. Real-world barriers such as adherence and stigma continue to negatively affect health outcomes, quality of life and transmission risk, reinforcing the need for long-acting medicines that address these challenges while delivering public health benefits and significant revenue growth. Treatment represents 90% of the current HIV market, the largest unmet medical need and remains our priority. By 2035, we expect this market to be worth approximately GBP 25 billion, with growth driven by uptake of new long-acting regimens despite daily oral generics entry and pricing pressure. For prevention, we expect this market to be worth approximately GBP 6 billion by 2035. Across both treatment and prevention, long-acting injectables are the fastest-growing segment, and we are leading this market transformation from daily oral to long-acting HIV care that improves patient experience, supports adherence and drive sustained competitive growth. We have been at the forefront of HIV innovation for nearly 4 decades, leading transformational changes in patient care through the first 2 drug oral therapies and then Cabenuva and Apretude, the first-to-market long-acting injectables for treatment and prevention. Our current portfolio and future pipeline are built on the foundation of integrase strand transfer inhibitors, or INSTIs, which are trusted by health care providers worldwide due to their superior efficacy, long-term tolerability, high barrier to resistance, and they form the basis of over 80% of treatment regimens globally. Today, we will focus on our near-term growth drivers, 3 times a year treatment, 2 times a year treatment and 3 times a year prevention. However, as you can see beyond these transformational opportunities, we will continue to innovate to address the health of people impacted by HIV for many years to come. This includes best-in-class long-acting orals, which we see as an opportunity to reach the around 30% of patients who our market research suggests may not choose injectable treatment. We have initiated a Phase I study for VH359, a capsid inhibitor and have multiple potential weekly oral INSTIs and capsid inhibitors in preclinical development. Our leadership in long-acting will continue to fuel our growth with each innovation building on our expertise to shape the future standard of care and reach more people impacted by HIV. Given our lead, we will have launched our second and potentially third long-acting injectable treatment before anyone else enters the market. Cabenuva is the first and only complete long-acting injectable HIV treatment. More than 5 years' worth of real-world and clinical evidence continues to validate the strength of Cabenuva, showing robust antiviral effectiveness and barrier to resistance comparable to daily oral medications with strong persistence out to 2 years and substantial patient preference compared to oral therapy. In addition, Cabenuva demonstrated superiority over oral standard of care in the LATITUDE study, delivering nearly 2x lower regimen failure and 4x lower virological failure, leading to early study termination due to overwhelming efficacy in this suppressed high-risk HIV population with adherence challenges. The real-world data in viremic patients is also compelling, and we look forward to seeing data from our CROWN study in the second half of '26, assessing Cabenuva in viremic patients with adherence challenges to daily oral therapy. The entirety of this data shows the power of Cabenuva to lead the market growth in long-acting injectables through addressing preference, stigma, adherence and reducing the burden of daily oral therapies, supported by a robust IP strategy with cabotegravir NCE patent protection into 2031 and additional patent protection now granted into 2040. As the first mover in long-acting treatment, we have built the market from the ground up, establishing the evidence, infrastructure, provider experience and patient confidence needed to accelerate the adoption of future long-acting injectable innovations. We are now focused on franchise growth, continuing to address stigma and adherence challenges while meeting patients and health care provider preference for less frequent administration. The profile of our 3 times a year treatment constituting novel formulations of cabotegravir and rilpivirine is compelling. It builds on the proven efficacy and trust experience with Cabenuva, takes 365 oral daily treatment days down to just 3 injection visits per year, doubling provider capacity compared to Cabenuva, enabling clinics to serve more patients without increasing infrastructure. And this competitive profile is underpinned by a robust IP strategy with additional patent protection pending into 2047. I am pleased to share that QUATTRO, our 3 times a year Phase III registrational study in suppressed switch patients has begun, supporting potential approval in 2028. We remain confident that 3 times a year treatment will be transformational, not incremental, making long-acting treatment easier to choose, deliver and sustain, unlocking substantial switch opportunity from both oral therapy and existing Cabenuva, which will drive long-acting injectable market growth. Having set a high bar with our 3 times a year treatment, we are driven to keep innovating for people living with HIV by delivering a 2 times a year long-acting injectable treatment. Our preferred regimen is the combination of our third-generation INSTI, VH184, with our novel capsid inhibitor, VH499, a combination with NCE patent protection into at least 2040 and additional patents pending into at least 2047. We believe this regimen can set a new standard of care for a broad HIV population, bringing confidence in efficacy and a high barrier to resistance while further addressing adherence challenges. VH184 is currently in a Phase IIb clinical study, where we have seen rapid patient recruitment, reflecting the community's interest in its third-generation INSTI profile. Our differentiated capsid inhibitor, VH499, will commence its Phase IIb study in the second half of 2026. And we have a bold plan to get to Phase III in 2028 and approval by the end of the decade, combining operational insights from our ongoing 3 times a year QUATTRO study and utilizing the entirety of our Phase I and II data to select optimal doses and formulations to achieve what we believe will be a practice-changing profile. The data on this slide represents a subset of evidence of that practice-changing profile. The chart on the left shows VH184 retains superior potency over second-generation INSTI bictegravir against the majority of second-generation INSTI resistance mutations from the DAWNING clinical study. Its high potency and enhanced resistance profile positions it to transform HIV treatment, and we plan to determine its clinical efficacy in a resistant population to further inform our Phase III plans. The graph on the right shows VH499 does not cause the CYP3A-mediated drug-drug interactions that can lead to safety concerns for patients taking common concomitant medications or recreational drugs. It shows that VH499 had no effect on the pharmacokinetic profile of midazolam, the FDA recommended probe for exploring CYP3A drug-drug interactions. This data, combined with 499 and 184's strong efficacy and encouraging tolerability gives us a combination that is not just less frequent, but clinically and commercially differentiated, maximizing patient reach and transforming options for people living with HIV once again. Now moving to HIV prevention. The unmet need is significant. Despite the 2.2 million people in the U.S. that could benefit from prevention, only 25% use it. Daily oral persistence remains low, creating a major opportunity for long-acting options that better fit people's lives. Our 3 times a year prevention candidate, which contains a new formulation of cabotegravir builds on Apretude's greater than 99% efficacy and extensive real-world experience and is protected by a robust IP strategy with additional patents pending into 2045. Six months after a single dose of cabotegravir and lenacapavir in our CLARITY study, follow-up data reinforced cabotegravir's highly preferred injection profile with fewer, less visible and shorter-lasting injection site reactions, whereas 90% of participants continue to report lenacapavir-associated nodules at 6 months with 20% being reported as severe over that time period. Delivered through a single intramuscular injection, our 3 times a year prevention has the potential to combine strong tolerability, a favorable drug-drug interaction profile, a dosing schedule aligned to routine sexual health visits and the fewest maintenance injections per year, reducing treatment burden and supporting long-term persistence. With registrational study data from EXTEND4M anticipated in the second half of 2026 and approval in 2027, we remain confident it represents the optimal prevention option for both patients and providers. To close, HIV remains a significant, persistent and unresolved public health challenge. The market is moving towards long-acting innovation and we have built and lead with long-acting at the core to drive the market transformation. Cabenuva demonstrates the power of long-acting treatment and creates the foundation for continued innovation and a pipeline that keeps raising the standard of care. Our near-term long-acting injectable growth drivers are clear: 3x a year treatment to unlock the next wave of growth targeted for 2028 approval, 2x a year treatment, novel molecules designed for differentiation planned for Phase III start in 2028 and 3x a year prevention optimized based on patient and provider feedback targeted for 2027 approval. As HIV care continues to evolve, we are uniquely positioned to shape where the market goes next, combining scientific leadership, long-acting innovation and deep patient insight to deliver the next generation of treatment and prevention options. That brings us to the end of the R&D part of the presentation, and I will now hand over to Julie to share more on the funding of accelerate growth and our outlook.

Thank you very much, Charlotte, and also to all my R&D colleagues. So as you've seen, GSK has a broad and rich portfolio of opportunities. And the purpose of this section is to show you how we plan to fund it. Moving on to the next one. So one of our 3 priorities is to simplify the way we work. And this will be enabled by the Accelerate Growth program. We've identified GBP 1.9 billion of cumulative annual benefits to be delivered by 2029. And the majority of these will fund the investment opportunities outlined by Tony and his team today, accelerating 7 assets across 18 indications, and we have more than 20 Phase III trial starts in 2026. Now a proportion of the savings will also drop through, strengthening the margin through the dolutegravir loss of exclusivity period, which is 2028 to 2030. The program will deliver incremental sales from 2030 — it has a very strong IRR, and it will be implemented with financial discipline as usual, ensuring we retain capacity for business development. Turning to the details of the program. We expect 90% of the cumulative annual savings to be delivered by 2028. And we have undertaken an enterprise-wide review to identify opportunities with processes redesigned and enabled by technology and AI. Support functions and key processes across the organization will be streamlined for efficiency and impact. Procurement will be enhanced further to deliver maximum value. And we will also be reallocating resources from mature brands towards the key specialty growth drivers. And finally, there will be further automation and simplification of the supply chain and the network to align with the evolution of our portfolio. The program will cost GBP 2.4 billion to be reflected in adjusting items, of which GBP 2.1 billion is cash and the payback is 2.5 years before the reinvestment. We have a compelling track record of deploying cash in line with our capital allocation framework. First, invest for growth; and second, shareholder distributions, all underpinned, as you know, by a strong investment-grade balance sheet. Since the start of 2021, we have delivered more than GBP 40 billion of cash generated from operations. We've deployed GBP 18 billion to invest for growth by way of capital expenditure and business development. We have distributed GBP 16 billion to shareholders through dividends and the buyback. And we've reduced net debt through this period by GBP 6 billion, decreasing net debt to core EBITDA to 1.3x. This represents a considerable transformation of GSK and considerably improved cash generation and a significant reduction in net debt has led to the strengthening of our balance sheet, affording us the optionality to execute BD and further strengthen the pipeline, as you've recently seen through the acquisition of Nuvalent. We also have a strong track record of delivering profitable growth and increasing returns whilst continuing to increase the investment we've placed in R&D. So from 2021 to 2026, we are on track to deliver yearly sales growth of 8%, operating profit growth of 13% and more than a 540 basis point improvement in the margin. Now this is all whilst R&D investment has stepped up, increasing more than 50% to now more than GBP 7 billion and supporting a doubling of the Phase III starts in 2026, as Tony outlined. So looking ahead to our longer-term outlook and the impact to Accelerate Growth. We remain committed to our outlook of more than GBP 40 billion of sales in 2031, with more than 50% of our business in Specialty Medicines. Our operating margin is now expected to be stable to improving through the dolutegravir loss of exclusivity period, supported by a number of things. First, specialty continues to grow as a proportion of the portfolio. Second, we are driving increased productivity gains across the business. And third, part of the savings from the program overall will drop through to the margin in that 3-year period. Growth is then expected to accelerate from 2031 onwards, given the portfolio of products and the opportunity for further business development, the latter of which would be incremental to our commitments. This program allows GSK to build on the strong foundations we've laid over the past 5 years and accelerate growth from 2031 onwards. Thank you, and I will now hand back to Luke for final words.

Thanks, Julie. Next slide please. Today I opened by saying our focus was on products and growth. This slide shows the pathway we are building with our products to drive growth and deliver long-term value. The presentations from the team were designed to give you greater insight into how we are actually going to make that happen. To re-anchor you, at the start of the day I outlined that we would demonstrate the following: firstly, confidence in our ability to drive the business now and beyond 2031 by showcasing our late-stage pipeline and our focus on defined value propositions, and by providing some detail on how we are reallocating capital and resources to change and invest in R&D. With that, I think we're going to go to questions. I'll ask you to be quick. I wouldn't want to get into a gunfight with you. We'll bring the team up: Julie, Nina, Charlotte, Kaivan and I think Sanjay as well. As we said earlier, raise your hand—you clearly remember that. Zain, I think you were going to go first. Do you want to go now? I'll wait while everyone sits down. Zain, over to you.

We're going into some detail on how we are reallocating capital and resources to change and invest in R&D. With that, I think we're going to go to questions. I'll ask, guys, be quick. I wouldn't want to get a gunfight with you. We'll bring the team up: Julie, Nina, Charlotte, Kaivan, and I think Sanjay as well. And as we said earlier, raise your hand, you guys clearly remember that. Zain, I think you were going to go first. Do you want to go first? I'll just wait while everyone sits down. Zain, over to you.

It's Matthew Weston from UBS. One question really about — and it's about the financials before we get into all the detail because there's more time to dig into the detail later. Slide 24, you gave the illustrative picture of the impact of the new GBP 1.9 billion savings program. And it showed the cost base today and then it showed a smaller cost base in the future. And I think you're on track to deliver about 31% margin based on guidance in '26. So one of the most significant questions I've received today over and over is, does the new cost saving take that margin target higher? So am I right in interpreting Slide 24 that, yes, you are now aiming for margins up at the end of the 2031 period relative to where we are today?

The reservation in the slide that we shared was basically saying it was the cost base as a percentage of sales, first of all, as a result of Accelerate Growth. We are guiding to more than 31% margin in 2026. And what we've said previously before today was that the margin will be stable through dolutegravir LOE, which is 2028 to 2030. And we feel confident of that because the portfolio is pivoting more and more towards specialty, number one. And as you've seen over a number of years now and with this program, we are driving productivity and improvement in the business. So that brings us to date. Now what we've said is as a result of Accelerate Growth, we will also drop some of those savings through to the margin in the period of dolutegravir. So it builds in the dolutegravir LOE period, 2028 to 2030. We've not given a specific percentage, but what we have done is changed the margin guidance through dolutegravir now to say it will be stable to improving. So we're giving a range and recognizing the drop-through from the Accelerate Growth program.

I think Luisa, you are next, right?

Luisa Hector from Berenberg. I wanted to check on the asset accelerations. So you've highlighted 7. What are the criteria for accelerating? Is there some new decision-making in that mix? And then I don't think Neladalkib is an accelerated asset. Is there a reason for that? Maybe it's in flight too recent? And if I can also ask on probabilities of success and linking that to the validated targets. So you have this awesome selection now of pipeline. Is there a reason for probability of success being higher with the '25 Phase III starts? You talked about the validated targets. I don't know how much of those — what percentage of those are with validated targets and what that really means validated target.

Thanks, Luisa. I'll start, and then Tony will add a bit of color and then Deborah and others. A little bit of heritage: Nuvalent wasn't in that accelerated list because its programs were already running on a similar track and were more advanced. But if we can go faster, we'll look to do that. Essentially, we wanted to sit down and look at the portfolio, benchmark it versus external parameters, not just marking your own homework, but looking at what is a typical program timeline and what can we do to compress that without increasing risk. The other thing is, of course, as this portfolio is evolving, if you do have a validated target, you are removing elements of the risk, and therefore, you've got more confidence. Fundamentally, we wanted to identify the things that were stopping us from making the decision to go faster. Was there biological risk? Was it a resource risk? Was it our own process? And we compressed those. Each program had different combinations. Then we ran up against Julie, who said we need to pay for this. That's what triggered the second round, which is to reallocate resources within the P&L from areas with lower incremental return to the late-stage programs and BD. Tony, do you want to give a bit more color?

Why don't I just start a little bit with what data underpins confidence here. You start with the fact that our portfolio now has a significant number of assets that have broad potential associated with them. We've been integrating data from human causal data from genetics all the way through clinical characterization of patients to detailed molecular data. That allows us to draw lines of confidence in underlying biology across different indications. Couple that with the opportunity to execute clinical studies in an effective and appropriately gated way when we have relatively strong data. Those ingredients allow us to put confidence behind the 7 assets that we described: 7 assets, 18 indications and 25 studies. That combination, together with commercial assessment, is why we accelerated those.

To add to Tony's points and Luisa's question about confidence, I'll use some examples. Velzatinib — we've seen strong recruitment in ongoing studies, which gives us confidence there's clinical enthusiasm and that we can accelerate into first line. For the 2 ADCs, we have substantial data from our partner in China as well as our global programs. That combination gives us unique insights about signals and tolerability, and where we believe we can confidently accelerate. The decisions were data-driven. Teams brought in more than 100 opportunities and we prioritized those with blockbuster potential, feasibility and commercial impact.

And to stress something Luke said, we keep a close eye on the competitive landscape. For example, with TSLP there was a hint that other players were moving faster than us which prompted acceleration decisions. We look for the right balance of data, timing and competitive dynamics when deciding to accelerate.

We've got time for one more question. Simon, then we'll go for a break.

It's Graham Parry from Citi. On the accelerating growth post 2031, can you just help us understand what you're assuming for cabotegravir IP protection there? So you've talked about protecting through dolutegravir, but the cabotegravir LOE is 2031. It would be pretty major if you actually lost it there. So can you detail how you're expecting to protect that? And then secondly, on zidesamtinib, what's your confidence in the ability to get approval on the first-line data given I think it's only a 35-patient cohort and you've already got taletrectinib approved from TRuST12, which actually had more patients. And have you had any discussions with regulators regarding the filing yet?

Thanks for the question, Graham. We have a robust intellectual property approach. For Cabenuva (6x yearly treatment) we've got additional protection now granted through to 2040. For the 3x yearly treatment, we have additional protection pending through to 2047. For the 6x prevention formulation, the base patent runs to 2031; we don't have additional coverage for that yet. For the 3x yearly prevention, secondary patents are pending which would take protection out to 2045. So we have a robust suite of patents either granted today or pending, covering composition, formulation, and manufacturing methods. We are confident in IP protection and we also factor cannibalization timing into our commercial modeling — historically we've seen rapid uptake for improved dosing regimens, so the portfolio dynamics further protect value.

Making these long-acting injectable medicines is complex. We manufacture the API in Singapore using long synthetic chemistry, then do nanomilling and gamma irradiation before sterile filling. It's a multi-step, highly controlled process. It's not impossible to replicate, but it's technically challenging which creates additional barriers to entry.

On zidesamtinib and first-line, the Phase I study has been recruiting additional patients in that first-line cohort. Key for regulators will be demonstrating durability of response and follow-up. The data in the TKI-naive ALK population is encouraging — duration of response beyond 12 months and favorable tolerability. We expect to file later this year and are hopeful for a decision in 2027, but as always the timelines depend on data maturity and regulatory review.

Our next question comes from Steve Scala at TD Cowen.

Relative to the General Medicines guidance decrease, it was in part attributed to the soft environment. I'm curious what emerged in the last 3 months that led to this softness. Specifically, the company signed the agreement with CMS on June 15. So were there any details of that agreement, which were negative surprises?

I think the short answer is this is a portfolio of mature, older assets that continue to be under pricing pressure in many regions and face generic competition. One element contributing to the downgrade is Trelegy. We discussed this in Q1: we've seen increased abandonment rates in the U.S. for Trelegy and across the inhaled respiratory class. The abandonment trajectory is easing but remains higher than prior years, which affected performance in H1 and therefore full year expectations. We expect improvement in the second half and we do not expect a lasting structural change in patient demand, but it does affect near-term guidance. Julie, would you like to add?

That's a good summary. GenMed was under pressure in Q1 and that increased slightly in Q2. Trelegy had a tough comparator and higher abandonment. We expect the second half to be less pressured with no tough comp in Q2, so we expect some recovery in H2.

Pete Verdult, BNP. Just a few for Tony. What time lines are you working to ballpark to get your people into Cambridge? When it comes to this new accelerated R&D strategy, have there been any notable leadership changes to your team in the last 12 months? And then on your B7-targeting ADCs, there are many others out there. Are there any indications you'd call out where you think you could be first to market as a B7-H3 or B7-H4 targeting ADC?

For Cambridge, the plan is to move groups into the new site early 2029. We are elevating capabilities; for example, our Head of Clinical Operations now reports directly into me to improve delivery. We continue to hire clinical MD/PhD leaders and experts with deep translational experience. On ADCs, the advantages we see are based on data and platform properties. We have deep datasets from our partner in China plus our own global trials that provide signals across indications. For Ris-rez, non-small cell lung cancer has shown promising combination activity and could be a differentiating opportunity. Execution and translational strategies, including biomarker development, are critical to establishing differentiation versus competitors.

To add, it's not always about being first. It's often about delivering a meaningful clinical differentiation. Our platform has a validated linker-payload and we're seeing promising safety signals; translational work and biomarker strategy will help us target patient populations where we can demonstrate superiority or better tolerability. Non-small cell lung cancer and certain prostate cancer settings are areas where we see near-term opportunities to stand out.

Simon Baker from Rothschild & Co Redburn. A big picture one on R&D. It's clear that R&D at GSK in 5 years' time will be in a very different place. But I just wonder if you could give us an idea of the moving parts between the additional resources that's going in, productivity changes. And really, the key question is, how are you going to measure that change in improvement? How will we see that measure improvement beyond simply looking back in 8 years and thinking GSK accomplished more than it did in the previous decade? Where are we now, where are we heading by the end of the decade?

Great question. Where we were was a more distributed portfolio that included many lower-value opportunities. We've transformed that substantially: pipeline is larger, value per asset is higher, and we are 25% faster on average versus prior years. We track a concise set of KPIs across R&D — speed to decision, time to start for trials, study start-up time, and clinical development cycle times. For example, we expect to halve our study start-up time by 2028. We measure portfolio health, probability-weighted value, and time-to-market. We'll report progress against these regularly. The changes are tangible: more Phase III starts, more high-value indications and demonstrable acceleration in timelines.

Our next question comes from Zain Ebrahim at JPMorgan.

Zain from JPMorgan. First question on the GBP 40 billion 2031 target and beyond. Is Nuvalent included in the greater than GBP 40 billion sales ambition? And how much of the ambition beyond 2031 is dependent on business development? Second, on 2027 margins: given the cost savings that will help offset dolutegravir, but with royalties (Gilead), IRA impact potentially and R&D growing faster than sales, how should we think about 2027 margins relative to consensus expecting expansion?

On the GBP 40 billion target, we are totally committed to delivering more than GBP 40 billion in sales in 2031. Nuvalent is part of our expanded portfolio and contributes to that ambition. We are not assuming additional BD beyond our current commitments to hit the target, though BD would be incremental on top if it occurs. On margins, we've guided for more than 31% in 2026. For the dolutegravir LOE period (2028–2030) we had previously said margins would be stable; today we've said margins will be stable to improving because Accelerate Growth will deliver GBP 1.9 billion of cumulative annual benefits by 2029, some of which will drop through the P&L in that period. We didn't provide a year-by-year margin percentage for 2027, but the program provides the optionality to protect and potentially improve margins through the LOE period. For modeling, assume R&D investment will grow faster than sales in the near term while SG&A is reduced via productivity; net effect is margin stability to modest improvement through the LOE window.

One on vaccines and corporate structure: It seems pharma and vaccines may have different outlooks and capital needs. How wedded are you to continuing to own vaccines given potential value unlocks from separation?

Short answer: we remain committed to owning vaccines. It's a durable business with high barriers to entry and strategic synergies with our specialty and general medicines franchises. There is short-term pressure post-COVID in some regions, but long term the market fundamentals and public health value are strong. We will focus on operational effectiveness and participation in innovation.

Two on HIV and one on R&D. First, the plan for 6-monthly prevention — is that still part of the roadmap? Second, 2x yearly treatment: when could that launch relative to 2028/2030 timing? Third, on long-acting orals: any view on when weekly or monthly long-acting oral treatments could be on the market?

On 6-monthly prevention: our market research and provider feedback suggests 3x yearly is the optimal balance. We remain committed to twice-yearly options for a subset of the market and have a cabotegravir prodrug entering the clinic which could enable twice-yearly dosing; we'll provide a timeline later. On 2x yearly treatment, our plan is bold: we aim to start Phase III in 2028 and target approval by the end of the decade (around 2030). We will use learnings from the QUATTRO study (3x yearly) to inform Phase III for 2x yearly. For long-acting orals, we are working on weekly oral options. VH359 (capsid inhibitor) is in Phase I; other weekly oral INSTIs are preclinical. We will provide more time lines as data matures, but we see a clear path to weekly oral development.

First, regarding the Shingrix MACE study: is the ambition to ultimately secure a labeling change for Shingrix based on cardiovascular outcomes? And what would that mean for pricing? Second, on GenMed: is there a risk that in reallocating resources to specialty you end up underinvesting in GenMed brands and might consider divestment?

Yes — the ambition for the MACE study is to generate data that could support a label claim. The real-world evidence signal has been consistent across multiple datasets and we're running a randomized, controlled Phase III to test causality. We are in discussions with regulators and the reception has been favorable. If we can demonstrate a causal reduction in MACE, that would materially change clinical practice and payer value assessments. On pricing, a positive outcome would strengthen the value proposition and could support premium pricing, but any price change would depend on payer engagement post-data.

On GenMed: GenMed remains an important, cash-generating part of our portfolio and supports field force synergies across vaccines and specialty. We do expect to reallocate resources from mature brands towards specialty growth drivers, but this does not mean we will neglect GenMed. We will continue to evaluate strategic options, including partnerships and selective divestments where they create more value, while ensuring commercial coverage where it adds strategic benefit.

Following the camlipixant failure, what learnings have you taken into future business development decisions? And on Apretude in PrEP, how is it faring versus competitors and what do you expect if Merck launches a once-monthly oral option?

On business development lessons: we remain committed to BD as central to our strategy. Camlipixant was an adjacency with high unmet need; we assessed it thoroughly and when Phase II/III data did not support a meaningful patient benefit at scale, we reallocated capital. It reinforced the importance of hard endpoints and robust translational data in de-risking BD deals. On Apretude: the PrEP market is reshaping. Long-acting options are growing rapidly; Apretude grew 39% in the quarter and we are holding share in a fast-growing market. More choices are good for patients; if Merck introduces a once-monthly oral, we expect competition but also an expanding market with higher overall uptake as more people find options that suit them.

On bepirovirsen: can you provide a sense on launch sequencing and speed of payer uptake given the mix of commercial and government payers? For IL-33 in COPD, do you have an internal target for exacerbation reduction relative to existing biologics? And for Neladalkib recruitment dynamics — can you accelerate first-line recruitment further?

On Neladalkib recruitment — following the ASCO and recent data releases we've seen pickup in interest and enrollment. We see potential to accelerate recruitment through investigator engagement, advocacy groups and leveraging our global clinical operations. For first-line especially, there is strong enthusiasm; we expect increased momentum over the next 6–12 months.

On bepirovirsen adoption: patients currently on long-term nucleos(t)ide therapy who want a potential functional cure are likely to be early adopters. Testing rates vary by geography; Asia has higher baseline testing whereas in the U.S. testing is less common because it hasn't been actionable historically. We expect uptake to be driven by awareness, testing implementation and payer coverage discussions after approval. Pricing expectations are informed by comparators such as hepatitis C historical precedent, but final pricing will be determined with payers post-approval. There will be a phased access approach with commercial payers and later Medicare engagement.

Related to uptake patterns, we do not expect a single massive bolus similar to early HCV — the patient mix and treatment context differ. We expect a faster uptake among motivated patients who see the value of a potential functional or partial cure, but it will be more steady and geographically varied.

On IL-33: this is a different mechanism to the T2-targeted biologics. For COPD, we expect the most meaningful benefits in severe events and hospitalizations, potentially also in cardiopulmonary outcomes. Exacerbation reduction targets will vary by enriched population; we are designing pivotal studies to capture meaningful, clinically relevant endpoints beyond spirometry, including severe event reductions and cardiorespiratory composites. One of the pivotal starts will be a cardiorespiratory outcome study with a leading cardiovascular outcomes research organization which we'll commence next year in parallel with more conventional exacerbation studies.

Two quick ones: on Cabotegravir IP, are you assuming the patent extensions in your forecasts? And on IL-33 partnering for the cardiorespiratory outcome study — will partnering with an outcome research organization slow you down?

In our baseline forecasting, unless an extension is granted, we model the earlier patent expiry dates. That is standard practice. We do however have granted and pending patents that extend protection for key formulations and combinations, and we model potential cannibalization dynamics between product generations. Regarding the cardiorespiratory outcome study, partnering with an established academic research organization (ARO) or CRO that has deep experience running cardiovascular outcomes trials enables us to move faster and ensure high-quality execution. It should not materially slow the program — it will add rigor and operational expertise.

Our next question comes from Seamus Fernandez at Guggenheim.

A question on ultra-long-acting TSLP: clinicaltrials.gov shows an ongoing formulation study, but you are planning to move forward in the second half of this year. Can you provide color on your confidence that the formulation will provide full 6-month coverage? And how confident are you that TSLP will show robust results in COPD — should we expect enrichment by eosinophils?

I'll start and then Kaivan can add specifics. We evaluated available ultra-long-acting TSLP programs and chose an asset with strong durability data. The decisions were based on phase II pharmacodynamics and formulation data plus partner data. Kaivan?

We are confident. We have Phase II data supporting a Q6M (6-month) profile in asthma and additional nasal polyps data from our partner Hengrui that supports dosing and pharmacodynamics. The Phase III program will start this year with dose selection informed by those datasets. For COPD, TSLP is expected to be active primarily in intermediate-to-high T2 subgroups; we'll enrich studies based on eosinophils and clinical phenotyping. IL-33 is expected to address a broader, T2-agnostic segment of COPD.

Following the Bellus/camlipixant failure, are there specific learnings for BD going forward?

Bellus reinforced the importance of robust human biology and hard endpoints; it emphasized that even well-rationalized mechanisms can fail in execution for reasons such as trial design sensitivity and behavioral effects like Hawthorne. That lesson is embedded in our BD process now — we focus on validated biology, complementary datasets, and careful go/no-go criteria tied to meaningful clinical endpoints.

And on Apretude/PrEP market share evolution versus Gilead and what you expect if Merck launches a once-monthly pill?

The PrEP market is growing rapidly as long-acting options replace suboptimal daily oral adherence. Apretude grew 39% and we are holding share in a fast-growing market. More options will expand overall uptake; we expect to hold our position and continue to grow the segment. A once-monthly oral would increase choice and competition, but we believe injectables and novel formulations will continue to drive the biggest change in adherence and prevention.

Thanks. That's all from me.

Thanks, Kerry. That concludes our first Q&A. We'll take a short break and reconvene shortly. If we didn't get your question, we'll ensure we follow up with you. Please be back by 3:35, and we'll continue with the next sessions.

Break.

Zain from JPMorgan. First question is just on the 2031 target and beyond. You mentioned Nuvalent earlier. Is Nuvalent included in the more-than-GBP 40 billion ambition? And on the ambition beyond 2031, how much is dependent on business development? Second, on 2027 margins: you've got the dolutegravir period protection and cost savings to help offset that, but with potential royalty payments, IRA impact and R&D outpacing sales growth, how should we think about 2027 margins?

Yes, Nuvalent is part of our expanded portfolio and is included in the broader ambition. We're committed to delivering greater than GBP 40 billion in 2031 on the basis of our current pipeline and plans. The Accelerate Growth savings begin to materialize and are intended to fund the R&D investment and also to protect margins through the dolutegravir window; while R&D will increase near term, the productivity savings and portfolio mix shift toward specialty underpin margin stability to modest improvement across the LOE period. Any future BD would be incremental to this base plan.

One follow-up on vaccines: given differing capital and operating characteristics between vaccines and pharma, would you consider separation in the future to unlock value?

We are wedded to vaccines. The business offers durable returns and strong public health impact with barriers to entry. We will continue to optimize operations and invest selectively in innovation where it aligns with our strategy.

On the Cabenuva family — the prior plan had a 6-monthly prevention product possibly in 2028, but I didn't see that on the slide. Are you not pursuing 6-monthly prevention? For treatment, when might a 6-monthly treatment be available? And when could long-acting weekly or monthly oral options realistically be in the market?

Our preference research shows 3x yearly prevention aligns well with patient care patterns and clinic visits; hence we are prioritizing 3x yearly prevention. We are not abandoning twice-yearly options; we have a cabotegravir prodrug moving into the clinic which could enable twice-yearly dosing — we'll outline time lines when ready. For the 2x yearly (twice-yearly) treatment, our aim is to start Phase III in 2028 and seek approval around the end of the decade (circa 2030). For long-acting orals, VH359 (capsid inhibitor) is in Phase I and we have multiple others in preclinical. We will update on time lines as data supports them, but we are actively progressing weekly oral candidates.

Regarding the Shingrix MACE study and labeling ambitions — are you aiming for a labeling change, and will you pursue pricing changes if the study is positive? Also, regarding General Medicines reallocation, is there a risk of underinvesting and might that lead to divestments?

Yes, the ambition is to establish a causal effect and support a possible labeling claim for reduced MACE risk. The MACE endpoint is well defined and regulators are engaged. If positive, a label change would strengthen physician recommendation and payer assessment which could support pricing discussions. For dementia endpoints the pathway is more complex, so MACE is the initial priority.

On General Medicines: this remains an important and cash-generating part of our portfolio and creates synergies in the field force across vaccines and specialty. We will reallocate resources to higher-return specialty areas, but we will support GenMed where it adds strategic value. We will consider divestments where appropriate to create incremental value, but we are focused on execution and protection of core capabilities.

How will you measure progress in R&D transformation beyond aggregate statements? What are the concrete KPIs we should be watching?

We track a concise set of measurable KPIs across discovery and development: pace to decision, number of Phase II/III starts, study start-up times, time from Phase II readout to Phase III start, and portfolio probability-weighted value. We expect to halve study start-up time by 2028. We'll report progress against these over time; the proof will be in the pipeline acceleration and quality of assets reaching Phase III.

Our next question comes from Michael Leuchten at Jefferies.

Two questions. First, on Cabotegravir IP: which expiry dates are you assuming in forecasts? Second, Kaivan — you mentioned the cardiorespiratory outcome study for IL-33 with a partner. Will partnering slow execution?

We model the earlier expiry dates unless extensions are granted. For example, base NCE protection for cabotegravir runs to 2031; other patents and combinations extend protection for specific formulations and uses. We will update forecasts as additional patents are granted. On the IL-33 outcome study, partnering with an experienced ARO or CRO actually accelerates high-quality execution because they bring operational expertise in large outcomes trials. It will not materially slow us down.

To be clear, the cardiorespiratory outcome study will be run with a partner experienced in large cardiovascular outcomes trials. This collaboration provides established infrastructure and should enable efficient, high-quality execution rather than slow us down.

Our next question comes from Seamus Fernandez at Guggenheim.

Regarding ultra-long-acting TSLP, clinicaltrials.gov shows an ongoing formulation study, but you plan pivotal starts in the second half of this year. How confident are you in the 6-month coverage pharmacokinetics across indications and will you rely on partner data?

We have Phase II data demonstrating the Q6M pharmacodynamic profile in asthma and complementary data in nasal polyps from our partner that supports dosing. These combined datasets underpin our confidence for dose selection and registrational study starts across asthma, nasal polyps and COPD.

Given the Bellus/camlipixant outcome, how has your BD screening changed since then?

We now place even more emphasis on validated human biology, robust clinical endpoints and translational data packages. The approach is more selective, focusing on assets with de-risked mechanisms or clear differentiators. We have not stopped BD; we've refined criteria and continue to be active.

Follow-up on Apretude and PrEP: how is uptake versus Gilead and what will competition do?

The PrEP market is growing and Apretude is performing well, up 39% and holding share. Long-acting options are expanding the market and improving persistence. Competition increases choice and should grow overall adoption; we remain confident in our position.

We have time for one last question.

Two quick ones: first, given GSK's data assets and interest in AI, why wasn't AI emphasized more today? Second, why increase R&D presence in the U.K. (Cambridge) given potential constraints and limited domestic patient access to some products?

AI is central to our approach, but we keep specifics close to the chest because they are competitively sensitive. We have about 150 people in our AI group working on data-driven discovery, translational insights and clinical execution optimization. Our focus is on actionable data and deploying AI where it materially accelerates decisions. On Cambridge — we're building proximity to world-leading academic partners and an ecosystem of biotech and AI companies; the goal is to accelerate discovery and access to translational data. We'll also build capabilities on the East Coast U.S. and in China — Cambridge is an important global hub for this strategy.

Thank you all for your time, your questions and engagement today. I want to thank the presenters and the IR team for the huge effort behind this event. This concludes our session.