GSK - Q4 2025

Transcript

Operator (participant)

Ladies and gentlemen, a warm welcome to the GSK Full Year 2025 Results Call. I'm delighted to be joined today by Luke Miels, Nina Mojas, Deborah Waterhouse, Tony Wood, and Julie Brown, and in our Q&A session, we will be joined by David Redfern. Today's call will last approximately one hour, with the presentation taking around 30 minutes and the remaining time for your questions. Please ask only one to two questions so that everyone has a chance to participate. Before we start, please turn to slide three. This is the usual safe harbor statement. We will comment on our performance using constant exchange rates or CER, unless otherwise stated. I will now hand over to Luke.

Luke Miels (Chief Commercial Officer)

Thank you, and welcome, everyone. My introduction today will have two parts: headline results for 2025 and our key focus areas in 2026 to drive value. Starting with 2025, results were strong. Sales were up 7% to more than GBP 32 billion. Growth was driven by Specialty Medicines, which were up 17%, with vaccines also contributing. Core operating profit grew 11%, and EPS was up 12%. Cash generation was strong at GBP 8.9 billion, supporting future investment and returns to shareholders, enabling the dividend upgrade of 2p to 66 pence declared today. R&D output remained very positive, with 5 FDA approvals and 7 new pivotal trial starts, and we maintained our high standards for being a responsible business. Looking forward, we expect another year of profitable growth, reflected in the guidance given today. Next slide, please.

In 2026, we expect momentum to continue, and we'll get there by focusing on execution and operational delivery. There are three areas where we're focused. The first is driving top-line growth by maximizing launch products like Blenrep and Extensa, and ensuring success in overall operational execution. Second, accelerating key assets in our late-stage portfolio like B7-H3, B7-H4, and Velsatinib in oncology, and Effi in MASH, and in our earlier portfolio, like the ultra-long-acting TSLP for respiratory diseases and regimen selection for our six-monthly treatment for HIV. Third, continue to execute business development, where we see a clear pathway to value creation, and our recent addition of the food allergy IgE antibody, Ozuriquimab, is consistent with this. Underpinning this will be a drive to simplify how we work with greater pace, accountability, and focus.

This starts by matching our best people and resources to the best opportunities to create value. Linked to this, changes have already been made to the executive team, bringing on commercial leaders with deep industry experience to increase our focus on products and execution, and this includes Nina Mojas, our new Head of Global Product Strategy, who I worked with for a number of years at AstraZeneca and Roche, who will present the commercial update. Importantly, we'll have an increased focus on leveraging practical use of AI and technology. I'll now hand over to Nina.

Nina Mojas (Head of Global Product Strategy)

Thanks, Luke. Please turn to the next slide. Overall sales for the year were up 7%, with strong growth driven by Specialty, up 17%, and another year of growth in all regions. Next slide, please. Respiratory immunology and inflammation, full-year sales were up 18%, driven by strong Benlysta and Nucala performance. In the year, Benlysta grew 22%, driven by higher demand and supported by all major guidelines. 82% of U.S. bio-naive patients are now starting on Benlysta due to its differentiated profile with organ damage prevention and more than 14 years of safety and experience. Nucala grew 15% and delivered GBP 2 billion for the year. This is the 10th consecutive year of double-digit growth for Nucala. Moving to Oncology, sales were up 43%. In the year, Jemperli sales were up 89%, reflecting our differentiated profile in endometrial cancer.

Ojjaara grew 60%, driven by growth in all markets following the new data at EHA, emphasizing the importance of early intervention. Based on these data, NCCN included Ojjaara as Category One for patients with anemia. We expect this to drive uptick in first line, although growth will be slower than what we have seen with second line. Zejula sales decreased, reflecting FDA labeling restrictions, and we remain focused on the potential we have for Blenrep, now approved in 15 markets globally. Deborah will cover HIV shortly. Given the continued strong performance and momentum across the specialty portfolio, we are expecting sales to grow low double-digit for 2026. Next slide, please. The strong performance of Nucala in 2025 was driven by our successful launch in COPD.

This launch also had a halo effect on all of Nucala's indications, resulting in higher market share in asthma and nasal polyps, also fueling brand growth in 2026. We are applying the lessons from the severe asthma market with Nucala to the launch of Xtentia, which is now approved in the U.S., U.K., and Japan. We know that there is a significant opportunity in the bio-naive population, as only 27% of U.S.-eligible patients are on a biologic. Market research shows that 97% of patients would prefer or likely switch to a biologic with six-monthly dosing. Xtentia has demonstrated a 72% reduction in exacerbations leading to hospitalizations in an indication where we know lack of therapy adherence leads to worse clinical outcomes....

The second key launch this year is for Blenrep, our off-the-shelf BCMA agent for multiple myeloma, available in the community setting where 70% of patients are treated. We've made fast progress on our launch in the U.K. and are applying lessons learned in the U.S., particularly around eye care networks. We've now engaged around 18,000 eye care professionals in the U.S., enabling smooth collaboration between treating physicians and eye care professionals, and have had positive feedback on the simplification of our ramps. We continue to expect this to be a slow ramp-up as we support prescribers and patients to ensure a positive first experience and robust adoption. I will now hand over to Deborah to cover HIV.

Deborah Waterhouse (CEO)

Thank you, Nina. We enter 2026 confident in our unique position to lead the next transformation in HIV care. Sales growth was 11% in the year, powered by accelerated patient demand for our long-acting injectables and our foundational oral two-drug regimen, Dovato. Demand continued to increase across all regions, most notably in the U.S., which grew 14% in 2025, continuing to outpace competition in market share gain. We're the only commercially established long-acting HIV treatment regimen, backed by over 4 years of real-world data. We're delivering long-acting innovation at scale and are delighted with our ongoing portfolio transition to long-acting regimens. In 2025, over 75% of our growth came from long-acting injectables, which now represent around a third of U.S. sales.

With treatment accounting for 90% of the total $22 billion HIV market, we are pleased that Cabenuva grew 42% in 2025, fueled by patient demand and accelerated switches from competitor products, reaching more than 75% in the US this quarter. In long-acting prevention, Apretude grew 62% in 2025, withstanding any impact from a competitor launch. In 2026, we expect continued growth momentum, and so today, we are guiding mid- to high single-digit growth. This quarter, we also announced Pfizer will exit ViiV, and Shionogi's shareholding will increase, simplifying the shareholder structure. GSK will maintain the same position. We look forward to continuing our highly successful collaboration to advance our pipeline and portfolio of long-acting HIV medicines.

Moving on to our INSTI-led long-acting pipeline, powered by unmatched patient insight, we are set to deliver transformative launches over the next decade, enabling us to navigate the Dolutegravir loss of exclusivity and accelerate long-term growth. We believe twice-yearly treatment presents our most significant commercial opportunity and, through a combination of novel assets, presents the potential to change the HIV treatment paradigm once again. At CROI, we will share data that will help inform our regimen selection for twice-yearly HIV treatment. Starting with VH184, a potential first-in-class, third-generation INSTI with IP protection through to at least 2040. We'll present key data on its unique resistance profile versus a competitor and findings from an ongoing first-time-in-human trial, exploring its significant potential for up to twice-yearly dosing.

We strongly believe this asset has the power to redefine the long-acting landscape, and we remain extremely confident in its potential to become the backbone of our long-acting treatment regimens. To pair with our INSTI once selected, we are evaluating two partners, VH499 and our bNAb, N6LS. Data at CROI for VH499 will show potential dosing durations. For N6LS, one of the broadest and most potent bNAbs in development, we'll share more data focused on Q4M dosing, with Q6M dosing data expected this year. This year, we'll also begin Quattro, our phase III registrational study for four-monthly HIV treatment.

This critical step builds on our Q2M success, and we are on track to file in 2027 and launch in 2028. At launch, we still expect to have the only long-acting treatment options on the market for years to come. Our strategy is clear, and our execution is strong. We are fully confident and well-positioned to drive sustained long-term performance, and we'll continue to update you on our Q6M regimen selection. We look forward to introducing you to our new head of R&D, Charlotte Allerton, who will succeed Kim Smith upon her retirement at the end of Q1. I'll now hand back to Nina.

Nina Mojas (Head of Global Product Strategy)

Thanks, Deborah. Turning to vaccines, sales were GBP 9.2 billion in the year, up 2%, driven by European and international region sales of Shingrix and Bexsero. Shingrix sales were GBP 3.6 billion, up 8%, driven by Europe and international region, offset by the US. In Europe, sales were supported by our focus on comorbid patients, and in international region, Japan continued to grow following expanded public funding, and in China, we saw similar sales to 2024. In 2026, we expect market performance outside of the US and China to benefit Shingrix sales, offset by slowing US immunization rates and our partner in China managing inventory. In meningitis, sales were up 12%, with strong continuous growth across Europe and international, driven primarily by Bexsero, up 16% for the year. Bexsero demand increased in Europe, partly due to MenB outbreaks.

Ex-US represents 69% of Bexsero's global full-year sales, demonstrating continued growth from national immunization programs and geographic expansion. In the US, we retain MenB market leadership with 74% market share and have seen positive signs for Pentavalent with initial stock building. Turning to Arexvy, sales were up 2% for the year, also driven by ex-US growth. We continue to monitor the evolving pediatric vaccine landscape in the US. At this time, insurance coverage remains as before, and we expect the recent HHS changes to be manageable, given GSK's broad portfolio of vaccines. For 2026, we expect sales growth to be in the range of low single-digit decline to stable. Next slide, please. Turning to GenMed, sales were slightly down for the year. Strong growth of Trelegy was offset by other respiratory and established products.

Globally, Trelegy continues to be the top-selling brand for asthma and COPD, and in the U.S., the ICS class is growing, with Trelegy leading in share driven by GOLD guidelines and strong execution. In anti-infectives, we are taking a targeted approach to align access to Blujepa in uncomplicated UTIs with positive initial insights. For complicated UTIs, we now have a PDUFA date of 18th of June for tebipenem in the U.S. Looking forward, we expect sales growth to be in the range of low single-digit decline to stable, reflecting pricing pressures and generic competition of our established portfolio. In the U.S., across the broader portfolio, we navigated the impact of the Medicare redesign from the Inflation Reduction Act near the upper end of our $400 million to $500 million range. I will now hand over to Tony to talk to you about our progress in R&D.

Tony Wood (Chief Scientific Officer)

Thank you, Nina. Next slide, please. Starting with the pipeline, there's greater focus and opportunity here than ever before. Our top priority is to accelerate development to deliver new products to patients faster. In 2025, we secured 5 FDA regulatory approvals and started 7 new pivotal trials: 3 for Extensa in COPD, 2 for efimostirmen in MASH, 1 for velsatinib in second-line GIST, and Risres, our B7-H3 ADC, in extensive stage small cell lung cancer. I'm delighted with the progress we're making to deliver the pipeline, shorten development timelines, and access world-leading innovation through BD. Next slide, please. In respiratory, we've extended our leadership through a focus on exacerbation prevention with long-acting treatments and now have approval for Extensa, the world's first and only six-monthly biologic to treat patients with severe eosinophilic asthma. Also in respiratory, COPD is a growing area of significant unmet need.

A patient hospitalized with an exacerbation has less than a 50% chance of survival over a five-year period, alongside a cost to US healthcare of around $7 billion per year. Our work to understand the role that inflammation plays in chronic airway disease has led to an emerging and differentiated pipeline of long-acting options for COPD patients. Starting with Extensa, the phase III ENDURA trials recruit patients at moderate risk of exacerbations, while VIGILANT is the first-ever study of an antibody for patients at an early stage of disease who are at risk of rapid progression. Our phase II trial, investigating the ultra-long-acting T cell monoclonal antibody GSK 283 in asthma patients, is on track to generate data by the end of this year and will further guide development of a six-monthly option for patients with a low T2 phenotype.

The portfolio also includes a PDE3/4 inhibitor with potential for DPI use in phase I development in China, complementing our leadership position with Trelegy. Looking now to refractory chronic cough. I'm pleased to confirm that we achieved last patient first visit for the CALM-2 study in December, and we're now on track to report phase III data from the total program around mid-2026, in line with our prior guidance. We believe Camlipixant will provide an effective treatment in RCC, where there are no approved therapies in the U.S. and approximately 10 million patients diagnosed globally who could benefit from this medicine. Next slide, please. A focus on inflammatory pathways of disease and how this leads to fibrosis, particularly in the lung, liver, and kidney, underpins our development programs in fibroinflammatory mechanisms.

We are pleased with the progress of efimostirmen, our potential best-in-class, once-monthly FGF21 analog, which started phase III trials for MASH last year. As a reminder, in phase II, EFI demonstrated sustained improvement in fibrosis and resolution of MASH in patients with F2, F3 stage disease. These data supported the start of our ZENITH One and Two pivotal studies. We plan to start the NEBULA phase III studies, which will recruit a more advanced F4 patient population later this year. Also in our hepatology pipeline is GSK 990, an siRNA therapeutic targeting HSD17B13. Consistent with human genetics of this target, preliminary data from the phase II STARLIGHT study in alcoholic liver disease demonstrates favorable trends in reduced liver enzymes, despite ongoing alcohol consumption, and this with no emerging safety concerns.

These assets have the potential to reverse cirrhosis, where 20%-50% of patients with associated complications die within one year. Next slide, please. Last month, we were pleased to announce positive results from the BEWELL One and BEWELL Two studies, our phase III trials of bepirovirsen for the treatment of patients with chronic hepatitis B, a disease which affects more than 250 million people worldwide, causing over 1 million deaths each year. We believe that BEPI has the potential to transform chronic hepatitis B treatment and become the first-ever fixed course of therapy with functional cure at a significantly higher rate than today's standard of care. This is important because chronic hepatitis B accounts for around 56% of liver cancer cases, and real-world evidence shows that functional cure reduces this risk by around 90%.

We look forward to sharing these data with regulators during the first half of the year and at an upcoming scientific congress. Next slide, please. Our oncology pipeline is a critical part of the portfolio. Starting with Blenrep, we anticipate mature OS data from DREAMM-7 in early 2028 to support second-line registration in the U.S. In the first-line transplant-ineligible setting, DREAMM-10 is recruiting well, and we recently expanded the number of U.S. sites to increase U.S. patient participation. DREAMM-10 uses a lower dose when compared to second-line studies and evaluates dual endpoints of MRD and PFS. Interim MRD and safety data are expected in early 2028. Also, in the first-line setting, we'll start a study looking at Blenrep quad regimen in a younger, fitter population later this year. Moving now to Ojjaara.

We continue to generate data to support decision-making for myelofibrosis patients with anemia, and a phase II study in myelodysplastic syndrome is currently recruiting. We also continue to develop lifecycle indications for Jemperli. Later this year, we anticipate results from a pivotal AZUR-1 trial for Jemperli in dMMR locally advanced rectal cancer. AZUR-1 was designed following the publication of transformative data, which showed 100% complete clinical response rate in a single-center monotherapy study. We're excited about Jemperli's potential for patients with this disease. Velsatinib, our KIT inhibitor, which targets all clinically relevant enzyme mutations, has started phase III in second-line GIST, with first-line to start later this year. Velsatinib has the potential to replace current standard of care and is designed to offer a well-tolerated schedule with greater efficacy against resistant mutations. Moving now to our other ADCs.

Our B7-H3 targeting molecule, which I will now call Risres, recently received its fifth regulatory designation with orphan drug status in SCLC. With this transformative potential in mind, we've initiated a global program encompassing multiple solid tumor trials for Risres, called EMBOLD. The first of these studies, EMBOLD SCLC 301, has started ex-US recruitment in second and third line. US recruitment will start later this year and include tarlatamab-exposed patients. We have extensive plans for additional Risres phase III starts in the next 12-18 months. In the first half of this year, we also plan to start recruitment for pivotal phase III trials for MoRes, our B7-H4 ADC in platinum-resistant ovarian cancer and in patients with recurrent endometrial cancer.

We're targeting a conference this year to present interim data from our early phase BEHOLD One study for patients with ovarian and endometrial cancers, and we anticipate further pivotal study starts for this molecule during 2026. Next slide, please. Business development is a core part of how we're accelerating our pipeline and accessing innovation. Two weeks ago, we announced an agreement to acquire RAPT Therapeutics, whose lead asset is Ozuriquimab, a potential best-in-class, long-acting, anti-IgE monoclonal for food allergy, which is currently in phase II. Food allergy is a chronic inflammatory condition with severe reactions leading to anaphylaxis, emergency care, and persistent lifestyle disruption. In the U.S., severe food allergies impact over 17 million patients, with an estimated $33 billion cost of economic burden, underscoring the need for more effective treatment options.

We expect the deal to close this quarter and look forward to progressing this important asset into phase III development. Next slide, please. In conclusion, 2025 saw further strong momentum in the pipeline, which continues into 2026. We have critical data readouts to come for BEPI, Camlipixant, Jemperli, Q4M PrEP, and Extensa for EGPA. We also have 10 pivotal starts planned for this year, including more than 5 from our ADCs, 2 for advanced MASH, and QUATRO, our Q4M treatment phase III trial for HIV, all of which are supporting our growth in specialty medicines. I'm excited about our progress and our prospects. I'll now hand over to Julie.

Julie Brown (CFO)

Thank you, Tony, and good afternoon, everyone. Next slide, please. Starting with the income statement for the full year, with growth rate stated at CER. As highlighted, sales grew 7%, while core operating profit grew 11%. This leverage was primarily driven by a 3% increase in SG&A, as investment in product launches was balanced with productivity improvements. Additionally, royalty income benefited from the RSV IP settlement, the new mRNA royalty streams, and Kesimpta performance. R&D growth of 11% reflects our acceleration of investment across multiple key specialty assets. Core EPS grew 12%, supported by the share buyback and lower interest expense due to strong operating cash flows. Finally, turning to total results, growth primarily reflects the impact of the Zantac charge taken in 2024. Next slide, please.

The operating margin increased 110 basis points in 2025, bringing total accretion at CER to 470 basis points over the last four years. This increase was primarily driven by SG&A margin improvement of 90 basis points, while gross margin continued to benefit from the portfolio transition towards specialty, growing 40 basis points. R&D expenditure increased as we reinvested the additional royalty income into our pipeline to support the initiation of the phase III Efimostirmen trials and prepared pivotal trials for the ADCs in multiple indications. Incorporated within this margin improvement were core charges of GBP 300 million taken in Q4, split evenly across supply chain and SG&A to drive productivity benefits. Currency was a headwind to margin, lowering the reported margin to 29.9% for the year. Next slide, please. Turning to the cash flow.

Cash generated from operations was GBP 8.9 billion, or more than GBP 10 billion, excluding Zantac payments, up GBP 1.6 billion year-on-year, driven by higher operating profit, favorable RAR movements, and the CureVac settlement, partially offset by increased trade receivables. Free cash flow increased to GBP 4 billion, or more than GBP 5 billion, excluding Zantac, driven by strong CGFO. Zantac payments in 2025 were GBP 1.2 billion, and the settlement process is now materially complete, with GBP 1.9 billion paid in total, drawing a line under this matter. Next slide, please. Turning to capital allocation. Underlying free cash generation was strong at over GBP 8 billion before investment decisions. GBP 4.5 billion was deployed in CapEx and BD, as we added three potentially best-in-class clinical stage specialty assets to the pipeline and completed multiple early-stage and platform deals.

Shareholder distributions totaled GBP 4 billion through the dividend and the share buyback, with 93 million shares repurchased at an average price of 1,473, and the remaining GBP 0.6 billion will be completed in half one. Overall, our balance sheet remains strong, with net debt to EBITDA relatively stable year-on-year at 1.3 times, including the absorption of Zantac and the buyback. Next slide, please. Now, turning to the guidance for 2026, with growth rates stated at CER. Starting with our headline guidance, we expect sales growth of 3%-5%, core operating profit and core EPS to both grow at 7%-9% and to pay a dividend of GBP 0.70, a 6% increase. Product area growth is once again led by specialty at a low double-digit percentage growth, including mid to high single-digit growth for HIV.

Vaccines and Gen Med are both expected to be a low single-digit decline to stable, and we expect sales growth to be evenly phased through the year. Turning to the P&L, gross margin is expected to continue to benefit from supply chain efficiencies and the portfolio transition towards specialty. SG&A will grow at a low single-digit percentage, benefiting from the acceleration of productivity initiatives. And R&D will continue to grow ahead of sales as we invest to advance the pipeline. Interest charges and the tax rate are expected to increase year-on-year. However, these will be offset by the benefits of the share buyback to EPS. Importantly, the phasing of operating profit growth will be heavily weighted towards the second half, reflecting the GBP 300 million pound of charges taken in Q4 2025 and impacted by the annualization of the RSV settlement in the second quarter.

Additionally, currency could be a headwind. If rates hold at the closing rates on the 28th of January, we would expect an impact of -3% on sales and -6% on operating profit. Next slide, please. Before I finish, I wanted to take a moment to share the continued performance of the business. In 2021, we provided outlooks on four financial KPIs for the five-year period to 2026. We have delivered consistent revenue growth and improvements in operational efficiency. We are on track to deliver against all the four KPIs.

Taking the midpoint of our 2026 guidance ranges would lead to delivery of 8% sales and 13% operating profit CAGR over this period. Additionally, cash generation has been significantly enhanced, and we're on track to reach more than GBP 10 billion in 2026. This, together with shareholder returns and a strengthened balance sheet, lay strong foundations for the next phase of growth. Our usual IR roadmap is shown in the appendix, signaling the major value inflections in 2026 and 2027. Thank you. And with that, I am pleased to hand back to Luke.

Luke Miels (Chief Commercial Officer)

Thanks, Julie. Looking forward, I see two clear things we need to do to create value for shareholders. The first one is top line. This means delivering on our ambition for 2031 and addressing the loss of dolutegravir exclusivity. The second is the pipeline. We need to accelerate what we have and add to it via smart BD, and we also need our labs to produce more competitive products. So to do these two things, we need to evolve as a company. Products are the key in this business, and we need to be more product-centric.

And to accelerate the pipeline, we need to have more scientific courage and be more agile to capitalize on opportunities when we see them. Each quarter, you'll hear more detail about how we're going to make this happen. Next slide, please. To conclude, 2025 was a strong year for GSK. For 2026, we're guiding for another year of top-line growth and operating leverage, and for the long term, we know what we need to do to create value for shareholders and patients, and the focus is now on evolving the company to do it. Thank you, and we'll now move to Q&A.

Operator (participant)

Thank you, Luke. With this, we are ready for the Q&A, and the first question comes from James Gordon from Barclays. Please go ahead.

James Gordon (Managing Director)

Hello, James Gordon from Barclays. Thanks for taking the questions. First one, respiratory. Can you elaborate on R&D commercial strategy in COPD and asthma? 'Cause you've now got Nucala, Extensa, and then IL-33 and TSLP all in development, but some overlapping products, and I don't want to double count. And so how do we think about segmenting this, given you've got products going for the same disease and then also quite a lot of these mechanisms also have multiple competitors also looking at them for the same diseases? The second question was HIV, and I heard the comments on long-acting, strong uptake and exciting next-generation data at CROI. But so when could we see the six-monthly treatment, and PrEP phase III trials start now? And, commercially, what is the implications of the four-month and six-monthly in terms of your TAM?

Because I've seen before, you've talked about the majority of sales in HIV being long acting in 2031, but then that might partly just because the orals are going to go away by then. So what's the TAM increase if these work? And maybe if I could squeeze in a clarification, did the GBP 40 billion+ revenue target, which has been reiterated, just is that the original assets, or is that also including some of the recent acquisitions you were talking about and the BD you're talking about, please?

Luke Miels (Chief Commercial Officer)

Great. Thanks, James, and I appreciate the question. So, Tony, should we?

Tony Wood (Chief Scientific Officer)

Yep

Luke Miels (Chief Commercial Officer)

Go into COPD, and then I might add a little bit of color at the end of that in terms of how we position the assets and what our thinking is. It's obviously always dynamic. And then, Deborah, do you want to cover HIV? I think we're in very healthy shape there, some more color there. And then, Julie, did you want to cover the assumptions around the 40? Again, I would just take this opportunity, just in case we get any other questions, to reiterate the commitment to the 40. And again, I think we have a clear pathway to that. So Tony, over to you.

Tony Wood (Chief Scientific Officer)

Yeah, let me, let me start. Thanks for the question, James. First of all, I'm really pleased with the progress we're making in respiratory. Obviously, just to mark last year, the Nucala approval in COPD in the middle of the year, and then at the end of the year, Extensa in severe eosinophilic asthma as the first ultra long-acting entry in our pipeline. I think what's important to understand about COPD, James, obviously, huge opportunity there, 300 million individuals globally and significant cost to the U.S. healthcare system, as I outlined in the presentation. But it's a complex disease, it's a heterogeneous disease, and that's why we're placing ourselves across a range of different long-acting mechanisms. The way you can think about it is there is the high EO population. This is where IL-5 and Extensa and Nucala are positioned.

And again, let me just emphasize there that we have a label which covers both the bronchiectasis and the emphysemic and mixed populations. Important when one considers the reality of a hospital admission for a COPD patient. You can then think about the intermediate T2 population, which is the 150-300. We were delighted to see the Nucala label there, but that's where we see, for example, our long-acting TSLP starting to play increasingly in the future, and then the low T2 population, and that's where we're positioning IL-33. So what we have, of course, is already starting in that high T2 population, the ENDURA 1 and 2 studies. That's the GOLD E population that we're looking at.

And the VIGILANT study, which, as I mentioned in the script, looks as a brand-new approach, looking at rapid progressers in that high eosinophil population. We also have ongoing phase I and phase II studies for the long-acting TSLPs and IL-33 mechanisms in the context of the stratification that I described. And then just to finish off, we'll be expecting in, in, in both of those to be starting pivotal studies over the next two to three years, once we have been informed by ongoing phase I and phase II work and competitor insights. And then lastly, just to finish off, important to emphasize, we also have the HRS-9821 molecule, which is the first nominated candidate from our Hengrui collaboration.

That's focused on dyspnea, which is associated pain associated with breathing, and fits nicely into our respiratory portfolio, given that that molecule has an opportunity to be a DPI-administered agent. Then lastly, in the lung group, we have the recent deal we did with Empirico, Empirico 012, and that's now called GSK821. That's a long-acting oligo, which is aimed at a broad spectrum, as I indicated. We haven't disclosed the mechanism yet, but we will in future as we gather more data.

Luke Miels (Chief Commercial Officer)

Yeah. And James, what I will say is we're going to resist the temptation as a company to construct a lovely PowerPoint slide that shows how we'll carefully capture this bit and have trade-offs amongst our products. I mean, there is strategic intent here, but we also recognize there's a Darwinian dimension here, in terms of the data that these targets generate, but also the competition gets a vote as well. I mean, ultimately, the long-acting is the future.

The launch for Nucala COPD in the U.S. is going very well, and was just there on Monday. We have around well, depending on which dataset, 43%-46% of new patient starts already. The market research and the messaging is really resonating, but we have transferred all of our Nucala reps to Extensa, and Nucala COPD is being promoted by the Trelegy legacy team. Because, again, we need to place our bets on the future, and the ultimate future with IL-5 and higher EOS is gonna be long-acting Extensa for COPD. So thanks, James, I appreciate that question. Deborah, do you want to give an update?

Deborah Waterhouse (CEO)

Thanks, Luke. So, the key thing that I wanna re-emphasize is that we're on track to select our Q6M treatment regimen in the middle of the year. And as I said, we're gonna do a meet the management event mid-year, where I'll lay out a lot more detail about the pipeline. But let me just give you a top-line view now. So let's start with treatment. The treatment market is $20 billion in value, 90% of the value of the total HIV market. As I said in my presentation, Q6M is clearly our biggest opportunity in treatment. We're very confident in the assets that we've got to choose from, and the Croyde data that we'll present will show just how strong those assets are, particularly VH184, which is unique.

Third generation, really potent integrase inhibitor, and we believe that to have a really potent regimen, you need to have an integrase inhibitor at the core. So in terms of what kind of when studies will start, Q6M treatment, you'll see us move into phase IIb this year. That puts us on track for our commitment, which is, the 28-30, launch for, our Q6M in treatment. In terms of PrEP, it's a, a different pathway because with the medicine that we're developing for Q6M PrEP, it's a pro-drug of cabotegravir, which we've talked about before, and that means that we'll be able to, go from phase I to phase III relatively rapidly.

And the phase one will be starting this year, where we'll then progress to dose selection, and then we'll do a bridging study from the data that we already have from Q2M. So our Q6M pathway is clear, and we're very confident in our ability to deliver against our milestones. But don't underestimate Q4M. There is a huge desire for Q4M in treatment and in PrEP, and we know that many clinicians are really looking forward to opening up their clinic capacity, which will double from what they've got today with Q2M, for Q4M. And I think what you're gonna see is a rapid cannibalization of 2 Q2M to Q4, and then actually you will see a rapid cannibalization from Q4 to Q6.

As I've said before, particularly in treatment, you see the market really open up as we progress through longer and longer durations between administrations. So the addressable market for Q2m is about 15% of patients. When we get to four, we get to 30% of patients, and then you've got, with Q6m in treatment, 50% of patients who would be very willing to take a long-acting injectable. That is a big chunk of the market, which is why we are so excited about the offering that Q6m in treatment and in PrEP, but particularly in treatment, will offer.

Luke Miels (Chief Commercial Officer)

Thanks, Deborah. Julie, quick answer on the 40. I think everyone knows-

Julie Brown (CFO)

Yeah.

Luke Miels (Chief Commercial Officer)

But let's confirm it.

Julie Brown (CFO)

Yeah, sure. Thanks, James, for the question. So in terms of what we've included, of the recent deals, IDRx has included Efimostirmen, together with the earlier stage Hengrui license, PDE3/4. Rapt, obviously, has just been announced, so it's not included at all in the LRF. And clearly, we continue, as Luke mentioned, to support our BD, to build and continue to build the pipeline.

Luke Miels (Chief Commercial Officer)

Great. Thanks, Julie. Next question, please.

Operator (participant)

Thanks, James. Next question comes from Simon Baker, from Redburn.

Luke Miels (Chief Commercial Officer)

Hi, Simon.

Simon Baker (Equity Research Analyst)

Good morning, everyone. Thank you for taking my questions. Two, if I may, please. Firstly, on Blenrep, in light of the early feedback that you've had, you talked about the response to the REMS program. Can you just update us on how we should be thinking about the launch trajectory for Blenrep? And then secondly, a slightly bigger picture question for you, Luke. You did mention some of the facets of your strategy. I just wondered if you'd give us a bit more detail on how and in what form we're gonna learn more about that strategy over the course of the year. Is this something where there will be additional disclosure as we go through the quarterly calls, or are you envisaging having capital markets day or similar events to lay out the strategy in that sort of form? Thanks so much.

Luke Miels (Chief Commercial Officer)

Thanks, Simon. I'll come to Nina in a second. I mean, I think, as I said earlier, and thanks for your questions. Look, what you'll get from us is a very clear communication. If it's on track, you'll hear about it. If it's not, we'll call it out. And I really want to use these forums to regularly update on our progress and where we're going to. So I think these are a very effective forum to do it. And we'll see how that evolves over time. Nina, I mean, again, as I said in my intro, I mean, Nina and I have worked together a long time. She has huge experience in oncology and is now responsible for the whole portfolio in partnership with Tony....

And also, we've had a number of other members join the team that have been in their roles during this commercial transformation. And there's a lot of, yeah, history with those individuals at Aventis and Roche and AstraZeneca. So they're people that many of you will know, and they've got a very strong record. And the aim of bringing them into the team again is just to rebalance and increase their focus on the portfolio, the pipeline, and product execution. So, with that intro, Nina, over to you on Blenrep in terms of launch, uptake, and initial initial feedback.

Nina Mojas (Head of Global Product Strategy)

Yeah, thank you. Just checking you can hear me?

Luke Miels (Chief Commercial Officer)

Yep.

Nina Mojas (Head of Global Product Strategy)

Yeah, great. Yeah, Simon, so, you remember Blenrep was launched in the U.S. just at the end of November, so there are not many, we can't really share a significant update based on the sales numbers. But what we do know, we launched in the U.K., middle of the year, and, the dynamic is, opening the accounts is, systematic. It's happening, but it is definitely slower because of the coordination of care with eye care professionals. By now, we have about 70% of patients covered in the accounts that are open in the U.K., and, based on the, uptake there, we are actually extremely satisfied.

Two things, there is huge interest to try Blenrep, and then, we know that, that we have done good, good homework in, guiding physicians how to use the drug. Physicians are very much aware of the need of extended, dosing intervals to reduce or to reduce or, or to avoid, eye-related side effects. Now, translating that to the US, we expect similar dynamic. So the timing of opening the accounts, is going to take a, a, a bit of time, longer probably than what you would see with an asset that doesn't need that coordination of care. But what we, we did learn from the first launch, as an example, I think I mentioned we, are actively educating 18,000 eye care professionals.

As an illustration, comparing to the first launch of Blenrep, we had only about 5,000-6,000 eye care professionals engaged in our program, helping treaters to treat the patients. REMS has been a big factor. I think you know that. It has been received very positively. Currently, REMS is not an issue. Physicians are very much used to REMS programs, and Blenrep REMS is very similar. Eye care professionals scale, as we said, we are going to reach a significantly higher number, and then communicating to the physicians how to use the drug.

That extended dosing is very relevant to enable early positive experience, and I would say that's what we see so far. To your question, what can we expect? What we said before, it is not going to be a quick ramp-up, it's going to be a slow ramp-up, but the positive initial experience is more relevant than starting a high number of patients very early and then having a negative experience.

Luke Miels (Chief Commercial Officer)

Thanks, Nina. I would just add one other, one other interesting data point: if we look at usage right now for Blenrep, it's about 50/50 between academic and community, which, you know, our strategy is to focus on the community. With a product that is being relaunched and not a lot of experience in the community, I think this is an encouraging trajectory, because at this point, you'd expect volume to be dominated by the academic centers who tend to move on newer things earlier. But we can see, to Nina's point, this strategy of focusing on the community, building confidence, supporting them to dose the first five patients, appears to be showing promise, and we will give you a lot more granularity at the Q1 update, including on depemokimab. Thanks, Simon. I appreciate the questions. Next, please.

Operator (participant)

Next question comes from Michael Leuchten from Jefferies.

Michael Leuchten (Equity Research Analyst)

Thank you for taking the question.

Luke Miels (Chief Commercial Officer)

Hi, Michael.

Michael Leuchten (Equity Research Analyst)

Hiya. Thank you for taking the questions. Two, please. One for Luke. It's been reported that there is a reduction in R&D staff, I think about 350 people in the U.S. and also in the U.K. Just wondering, is that part of a broader program, normal attrition? Just wonder if you could put it into context. And then back to Nina on Extensa. There's a few ways one could launch a product like this, especially early on, sort of go into experienced patients, where I guess it'd be easier to make an argument to get patients on drug more quickly or into a naive population to broaden out the market. Can you talk a lot about a little bit of the launch curve for 2026? So how should we think about this as the year progresses?

Thank you.

Luke Miels (Chief Commercial Officer)

Thanks, Michael. So I'll cover the first one. I mean, look, we're going to manage the business, and where we see success, we'll reinforce it. If we have programs that are less promising or Tony and Nina, in managing the portfolio, decide to cull something, then we're going to be very dynamic and shift resources behind to where we can get the best return, generate assets that are most compelling, and ultimately, in doing this, we will have happy shareholders at the end of the process. So this is very much this element of accelerating R&D and simplifying how we work. And you'll see more of that.

What we can assure you is that we will run the business with great discipline, and where we can see an opportunity, we will rapidly move resources, people, headcount, capital, to support that. Nina, AstraZeneca

Nina Mojas (Head of Global Product Strategy)

Yep, I can take that. Thank you, Michael. And just as a reminder, Michael, I think this information basically guides the strategy. We have about mid-twenties biopenetration in severe asthma, so about 25% of eligible patients now receive biologics, any. And of those who start on biologics, 65% will discontinue in the first 12 months. And that tells you if we would go for switch, active switch, that business wouldn't last very long because patients are dropping anyway. And I think we need to look at it in that context. Our main objective, I think Luke mentioned that, when we talk about our sales force, is going for bio-naive patients.

It's very legitimate to expect there will be some switching, and there will be switching very likely from Nucala, hopefully also from other agents in severe asthma as well. What is more relevant is, can Extentia gain share from patients who would have otherwise started on other agents? And you know, six-monthly dosing, I think you have seen everything that we have seen from both physicians and patients, is that there is huge level of enthusiasm for long-acting six-monthly dosing, and that will hopefully translate into referential use of Extentia over other agents to initiate patients, but then also to start patients who otherwise wouldn't start on biologic yet.

Luke Miels (Chief Commercial Officer)

Great. Thanks, Nina, and I think the positioning is the first and only biologic that delivers ultra-long protection in two doses a year. That's landing extremely well when we look at market research and perception. Thanks, Michael. Next question, please.

Operator (participant)

Next question comes from Sachin Jain, from Bank of America.

Sachin Jain (VP)

Hi, Sachin.

Hi there. Sorry about that. Can you hear me now?

Luke Miels (Chief Commercial Officer)

Yep, we can. Thanks.

Sachin Jain (VP)

Perfect, thanks. A couple of questions, please. Just, firstly to Nina, congrats on the new role. Perhaps a bit more detail on Blenrep. How many physicians have you had through the REMS certification process, and any cadence of how you think that will go through the year as a rate-limiting factor? Second one for Deborah on the HIV event mid-year. Clearly, we're looking to Q6M start, but I wonder if you will be disclosing how you think about the financials of that business through the LOE.

And I guess two questions: One, how do you think about the rate of decline of this business relative to where consensus sits? And I guess Q6M isn't in the midterm guide, so do you plan on including it at that point if you start the phase III? Then a quick one for you, Luke, just on your slide five and high-level objectives. You, you've mentioned two things. One, simplification. Do you intend to have any official cost savings program? And then secondly, R&D acceleration. Are there any specific programs that you can target for earlier readouts or filing? Thank you.

Luke Miels (Chief Commercial Officer)

Thanks, Sachin. So I'll answer your last question, then we'll go to Deborah, and then, finish with Nina. I mean, we are always looking to save money because, you know, I, I think that it's always an opportunity cost, right? So if we can move resources behind particular assets where we think there is a higher payoff and return, and they have the clinical profile to justify it, then we will do that, and we will continue that in a dynamic and disciplined fashion. Areas for acceleration, again, I think naturally the scale of B7-H3, Risres, is quite interesting. I think, 584, B7-H4, it is a very competitive and dynamic area, but, you know, I think we're starting to see some color around the tox profile that could give us an edge. FGF21, we looked at all three of those companies.

We think we've bought the best. Again, you'd expect me to say that, but I think we can back that up in time with the profile, the frequency of the dosing, and some of the profile of the product that'll emerge in time. So they're probably the key ones. TSLP as well, long-acting TSLP. Again, you know, the target is being actively de-risked by AstraZeneca, and I think that we have a plan to move that asset forward and rapidly because it is a very attractive area. We think, you know, long-acting can really reframe to Nina's earlier point about how respiratory diseases are treated. Deborah, over to you on HIV.

Deborah Waterhouse (CEO)

Brilliant. Thank you, Sachin, for the question. So if we think about Q6M first, so we are intending to set out our HIV story in the middle of the year. At that point, once we've done a regimen selection and we then commence with Phase II, we will put that into our long-range forecast, which is how we always operate when products get to that Phase two, that Phase II phase. You'll see that happen mid-year. You then asked about the evolution of the kind of the portfolio over time. Let me just give you a top-line view, and we will come back and talk more about this when we set out the HIV evolution in the middle of the year.

So we've seen a relatively rapid decline of Triumeq, as the guidelines have moved away from Triumeq. And what's happened is, over the last 12 months, it's created dynamism in the market, and Dovato has benefited significantly, as has Cabenuva. So the amount that's sitting in Triumeq and Tivicay, as you can see, is going down quite significantly in advance of the loss of exclusivity of dolutegravir, which is, to remind you, a glide path, not a cliff, starting in April 2028 in the U.S. and then July 2029 in Europe with obviously Dovato and Juluca in the U.S. having intellectual property coverage now until end of 2029 for Dovato and July 2030 for Juluca.

So the glide path's coming down. We're already seeing a move away from the old dolutegravir regimens into our newer regimens, and that is going to continue. And then what's going to happen is, we will continue to power forward with Cabenuva Q2M. It's doing incredibly well, growing fast. Apretude has not been dented by the launch of Sunlenca?, so that will also continue to grow 2026 and beyond. And then what we will see is Q4M, both treatment and PrEP, coming in and powering longer acting forward again until we reach the point at which we launch Q6M, and then we've got two brand-new molecules with intellectual property coverage, composition of matter patents through into the 2040s.

You see a dip in 2029 and 2030 for the franchise as we face into the largest erosion through the exclusivity loss, and then we come back out into growth in 2031 and beyond. That growth in that decade is going to be a significant contributor to GSK's success in the 2030s, because we are incredibly confident in the value to patients that the Q6m will bring. So if, you know, if, if that, that hopefully gives you a sort of a view as to how it's going to evolve. We will share more detail in the middle of the year, but I just want everybody to understand that HIV will be a big contributor to GSK's success this decade and into the future.

Luke Miels (Chief Commercial Officer)

Great. Thanks, Deborah. Nina, a quick answer-

Nina Mojas (Head of Global Product Strategy)

Yeah.

Luke Miels (Chief Commercial Officer)

And then we'll try and squeeze one more question in, because I know people have to stop.

Nina Mojas (Head of Global Product Strategy)

Yeah, definitely. Sachin, thank you. First of all, trying to avoid the situation where you will chase me next quarter for the same number. REMS, hundreds. Hundreds, and, and, obviously, that's, that's just a start.

Luke Miels (Chief Commercial Officer)

Yeah. I mean, we feel happy about where we're at. One more question. Do we have time for that?

Operator (participant)

Yeah, we have time for one more question. Next question comes from Steve Scala, TD Cowen.

Luke Miels (Chief Commercial Officer)

Morning, Steve.

Steve Scala (Senior Research Analyst)

Good morning. Thank you so much. Two questions. First, on Camlipixant. If GSK needs two positive trials to file, which is what the company has said previously, then what's the purpose of the pooled analysis? And/or has FDA confirmed it will accept filing based on pooled data, even if one trial is a negative? And secondly, on Shingrix, what were sales to Zhifei in Q4, and what is your level of confidence in 2026 on this, on this drug?

Luke Miels (Chief Commercial Officer)

Sure. Tony, you want to cover?

Tony Wood (Chief Scientific Officer)

Yeah, just quickly, hey, Steve, hi. Not going to get into details of regulatory strategy, but as you defined, what it's giving us is the option to take the approach both as independent and ultimately pooled studies. So it's worthwhile saying that we remain confident in the outcomes for both CAMEO-1 and CAMEO-2.

Luke Miels (Chief Commercial Officer)

Yeah, and Steve, there was a shipment in December. We can get you that number offline. I don't have it off the top of my head. What I will say is that the underlying demand is improving in China, so it's up six times since the start of 2025. Now, it's a low base, and we've grown the market share versus Ganwei. So now we have 93% market share in that population, which is, you know, an operational improvement. And what is driving this? We've shifted the strategy to the one that we launched in Australia and also drove in Germany, and now we're employing in the U.S., which is also helping us get some traction there. Julie just told me it's GBP 100 million we did at the end of last year.

So there's still some stock in the pipe, but again, we'll give you more color on Q1, but it's heading in the right direction, along with Shingrix, in aggregate. So I think we'll stop there, because I know a lot of you need to join another call, and I want to respect that. Thank you again for investing the time to construct such thoughtful questions and joining the call and your interest in the company, and we look forward to updating you further next quarter. Thank you.