Earnings Call Transcript - GSK Q4 2025

Operator, Operator

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. In our Q&A session, we will be joined by David Redfone. Today's call will last approximately 1 hour with the presentation taking around 30 minutes and the remaining time for your questions. Please ask only 1 to 2 questions so that everyone has a chance to participate. Before we start, please turn to Slide 3. 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, CEO

Thank you, and welcome, everyone. My introduction today will have 2 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 66p 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 3 areas where we're focused. The first is driving top line growth by maximizing launch products like Blenrep and Exdensur and ensuring success in overall operational execution. Second, accelerating key assets in our late-stage portfolio like B7-H3, B7-H4, and Velzatinib 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 6-monthly treatment for HIV. And third, continuing to execute business development where we see a clear pathway to value creation, and our recent addition of the food allergy IgE antibody, Ozekibart, is consistent with this. Underpinning this will be a drive to simplify how we work with greater pace, accountability, and focus. And 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. This includes Nina Mojas, our new Head of Global Product Strategy, who I worked with for several 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. And 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 increased by 7%, with strong growth in the specialty segment, which rose by 17%, and consistent growth across all regions. Next slide, please. Full year sales for Respiratory Immunology and Inflammation were up 18%, driven by strong performances from Benlysta and Nucala. Benlysta grew by 22% this year due to increased demand and backing from all major guidelines. Currently, 82% of bio-naïve patients in the U.S. are starting Benlysta due to its unique profile of preventing organ damage along with over 14 years of safety and experience. Nucala experienced a growth of 15%, achieving $2 billion in sales for the year, marking its 10th consecutive year of double-digit growth. In oncology, sales rose by 43%, with Jemperli sales surging by 89%, reflecting its distinct profile in endometrial cancer. Ojjaara saw a 60% increase, driven by growth in all markets following new data presented at EHA, which highlighted the significance of early intervention. Based on this data, NCCN has classified Ojjaara as Category 1 for patients with anemia. We anticipate that this will enhance uptake in first-line treatment, albeit growth may be slower than what we witnessed in second line. ZEJULA sales declined due to FDA labeling restrictions, while we are still concentrating on the prospects for BLENREP, which is now approved in 15 markets worldwide. Deborah will discuss HIV shortly. With the sustained strong performance and momentum across the specialty portfolio, we project sales growth in the low double digits for 2026. Next slide, please. Nucala's strong performance in '25 was fueled by our successful launch in COPD, which also positively impacted Nucala's other indications, leading to an increase in market share in asthma and nasal polyps, further driving brand growth in '26. We are applying insights from the severe asthma market with Nucala to the rollout of Exdensur, which has now been approved in the U.S., U.K., and Japan. There is a substantial opportunity in the bio-naïve population, as only 27% of eligible U.S. patients are currently on a biologic. Market research indicates that 97% of patients would prefer or be interested in switching to a biologic with 6-monthly dosing. Exdensur has shown a 72% reduction in exacerbations that lead to hospitalizations in a setting where we know poor therapy adherence results in worse clinical outcomes. This year, another key launch is for BLENREP, our off-the-shelf BCMA agent for multiple myeloma, which is available in community settings where 70% of patients are treated. We have made significant progress on our launch in the U.K. and are applying what we've learned in the U.S., particularly regarding Eye Care networks. We have now engaged about 18,000 eye care professionals in the U.S., facilitating smooth collaboration between treating physicians and eye care professionals, and we've received positive feedback regarding the simplification of our REMS. We expect this launch to progress slowly as we assist prescribers and patients to ensure a positive initial experience and strong adoption. I will now pass it over to Deborah to cover HIV.

Deborah Waterhouse, CEO, ViiV Healthcare

Thank you, Nina. We entered 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 2-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. With 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 1/3 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 U.S. this quarter. In long-acting prevention, Aplitude grew 62% in 2025, withstanding any impact from a competitor launch. In 2026, we expect continued growth momentum. Today, we are guiding mid- to high single-digit growth. This quarter, we also announced Pfizer will exit ViiV and Sinogi's shareholding will increase, simplifying ViiV 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 industry-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 entity with IP protection through to at least 2040. We'll present key data on its unique resistance profile versus the 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 that entity once selected, we are evaluating 2 partners, VH499 and our BNAbN6LS. 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 QUATRO, our Phase III registrational study for 4-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 Allison, 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 Bexero. Shingrix sales were GBP 3.6 billion, up 8%, driven by Europe and the international region, offset by the U.S. In Europe, sales were supported by our focus on comorbid patients. In the international region, Japan continued to grow following expanded public funding. In China, we saw similar sales to 2024. In '26, we expect market performance outside of the U.S. and China to benefit Shingrix sales, offset by slowing U.S. immunization rates and our partner in China managing inventory. In meningitis, sales were up 12% with strong continuous growth across Europe and internationally, driven primarily by Bexero, up 16% for the year. Bexero demand increased in Europe, partly due to MenB outbreaks. Ex U.S. represents 69% of Bexero's global full-year sales, demonstrating continued growth from national immunization programs and geographic expansion. In the U.S., we retained MenB market leadership with 74% market share and have seen positive signs for MenB with initial stock building. Turning to Arexvy. Sales were up 2% for the year, also driven by ex-U.S. growth. We continue to monitor the evolving pediatric vaccine landscape in the U.S. 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 '26, we expect sales growth to be in the range of low single-digit decline to stable. Next slide, please.

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 Exdensur in COPD, 2 for efimisfermin in NASH, for Velzatinib in second-line GIST and RRS, 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 Exdensur, the world's first and only 6-monthly biologic to treat patients with severe eosinophilic asthma. 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 5-year period, alongside a cost to U.S. health care 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 Exdensur, the Phase III ENDURA trial to 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 TS monoclonal antibody GSK283 in asthma patients is on track to generate data by the end of this year and will further guide the development of a 6-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 the last patient first visit for the KALM-2 study in December. We're 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 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 fibro-inflammatory mechanisms. We are pleased with the progress of Efimosfermin, our potential best-in-class once-monthly FGF21 analog, which started Phase III trials for MASH last year. As a reminder, in Phase II, Effi demonstrated sustained improvement in fibrosis and resolution of NASH in patients with F2, F3 stage disease. These data supported the start of our AZENIT-1 and 2 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 HST17B13. 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 with no emerging safety concerns. These assets have the potential to reverse cirrhosis, where 20% to 50% of patients with associated complications die within 1 year. Next slide, please. Last month, we were pleased to announce positive results from the B-WELL 1 and B-WELL 2 studies, our Phase III trials of Bepirovirsen for the treatment of patients with chronic hepatitis B, a disease that 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 DREAM-7 in early 2028 to support second-line registration in the U.S. In the first-line transplant ineligible setting, DREAM-10 is recruiting well, and we recently expanded the number of U.S. sites to increase U.S. patient participation. DREAM-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 cord 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 life cycle indications for Jemperli. Later this year, we anticipate results from a pivotal ASO-1 trial for Jemperli in DMMR locally advanced rectal cancer. ASO-1 was designed following the publication of transformative data, which showed a 100% complete clinical response rate in a single-center monotherapy study. We're excited about Jemperli's potential for patients with this disease. Velzatinib, 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. Velzatinib 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 Ris-Rez, 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 Ris-Rez called EMBOLD. The first of these studies, EMBOLD SCLC-301, has started ex-U.S. recruitment in second and third line. U.S. recruitment will start later this year and include tarlatamab exposed patients. We have extensive plans for additional Ris-Rez Phase III starts in the next 12 to 18 months. In the first half of this year, we 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-1 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 Rapp Therapeutics, whose lead asset is Ozureprubart, 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, Camli, Jemperli, Q4M Prep, and ensure for EGPA. We also have 10 pivotal starts planned for this year, including more than 5 from our ADCs, 2 for advanced MASH, and Quattro, 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 rates stated at constant exchange rates. As highlighted, sales grew 7%, while core operating profit grew 11%. This leverage was primarily driven by a 3% increase in selling, general and administrative expenses, as investment in product launches was balanced with productivity improvements. Additionally, royalty income benefited from the RSV intellectual property settlement, new mRNA royalty streams, and Kesimpta performance. Research and development growth of 11% reflects our acceleration of investment across multiple key specialty assets. Core earnings per share grew 12%, supported by the share buyback and lower interest expense due to strong operating cash flows. And 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 constant exchange rates to 470 basis points over the last 4 years. This increase was primarily driven by a 90 basis point improvement in SG&A margin, while gross margin continued to benefit from the portfolio transition towards specialty, growing by 40 basis points. Research and development expenditure increased as we reinvested the additional royalty income into our pipeline to support the initiation of the Phase III Efimosfermin trials and prepared pivotal trials for the antibody-drug conjugates in multiple indications. Incorporated within this margin improvement were core charges of £300 million taken in Q4, split evenly across supply chain and SG&A to drive productivity benefits. Additionally, currency was a headwind to margin, lowering the reported margin to 29.9% for the year. Next slide, please. Turning to cash flow. Cash generated from operations was £8.9 billion or more than £10 billion, excluding Zantac payments, up £1.6 billion year-on-year, driven by higher operating profit, favorable movements in receivables and the CureVac settlement, partially offset by increased trade receivables. Free cash flow increased to £4 billion or more than £5 billion, excluding Zantac, driven by strong cash flow from operations. Zantac payments in 2025 were £1.2 billion, and the settlement process is now materially complete with a total of £1.9 billion paid, concluding this matter. Next slide, please. Now turning to capital allocation. Underlying free cash generation was strong at over £8 billion before investment decisions. £4.5 billion was deployed in capital expenditures and business development 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 £4 billion through dividends and share buybacks, with 93 million shares repurchased at an average price of £1,473, and the remaining £0.6 billion will be completed in the first half. Overall, our balance sheet remains strong with net debt to EBITDA relatively stable year-on-year at 1.3x, including the absorption of Zantac and the buybacks. Next slide, please. Now turning to guidance for 2026 with growth rates stated at constant exchange rates. Starting with our headline guidance, we expect sales growth of 3% to 5%, core operating profit and core earnings per share to both grow at 7% to 9%, and to pay a dividend of 70p, reflecting a 6% increase. Growth by product area is once again led by specialty, with low double-digit percentage growth, including mid- to high single-digit growth for HIV. Vaccines and General Medicines are both expected to experience a low single-digit decline to stable, and we expect sales growth to be evenly phased throughout the year. Turning to the profit and loss statement. Gross margin is expected to continue benefiting 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. Research and development 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 from the share buyback for earnings per share. Importantly, the phasing of operating profit growth will be heavily weighted towards the second half, reflecting the £300 million of charges taken in Q4 '25 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 January 28th, we would expect a negative impact of around 3% on sales and around 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 key performance indicators 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 four KPIs. Taking the midpoint of our 2026 guidance ranges would lead to an 8% sales growth and 13% operating profit compound annual growth rate over this period. Additionally, cash generation has significantly enhanced, and we're on track to reach more than £10 billion in 2026. This, together with shareholder returns and a strengthened balance sheet, lays strong foundations for the next phase of growth. Our usual investor relations roadmap is shown in the appendix, highlighting the major value inflections in 2026 and 2027. Thank you. And with that, I'm pleased to hand back to Luke.

Luke Miels, CEO

Thanks, Julie. Looking forward, I see 2 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 2 things, we need to evolve as a company. Products are the key in this business, and we need to be more product-centric. 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. 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, Operator

And the first question comes from James Gordon from Barclays.

James Gordon, Analyst

James Gordon from Barclays. First one, respiratory. Can you elaborate on R&D and commercial strategy in COPD and asthma? Because you've now got Nucala, Exdensur, and then IL-33 and TSP all in development, but some overlapping products. 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 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 CORI. When could we see the 6-monthly treatment and PrEP Phase III trial start now? And commercially, what is the implications of the 4-month and 6-monthly in terms of your TAM? Because I've seen before you 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 just squeeze in a clarification, the $40 billion plus 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, CEO

Great. Thanks, James, and I appreciate the question. So Tony, should we 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'll 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 for that. So Tony, over to you.

Tony Wood, Chief Scientific Officer

Yes. 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, Exdensur in severe eosinophilic asthma as the first ultra-long-acting entry in our pipeline. I think what's important to understand about COPD, James, is that there's a huge opportunity there, with 300 million individuals globally and significant cost to the U.S. health care system, as I outlined in the presentation. But it's a complex disease. It's a heterogeneous disease. 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 a high EO population. This is where IL-5 and Exdensur and Nucala are positioned. And again, let me just emphasize that we have a label which covers both the bronchitic and the emphysemic and mixed population, which is important when one considers the reality of hospital admission for a COPD patient. You can then think about the intermediate T2 population, which is the 150 to 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. The low 2 population is where we're positioning IL-33. So what we have, of course, is already starting in that high T2 population, the EUA 1 and 2 studies, that's the GE population that we're looking at. The Vigilance study, which, as I mentioned in the script, looks at rapid progressors 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. Just to finish off, we'll be expecting in both of those to start pivotal studies over the next 2 to 3 years once we have been informed by ongoing Phase I and Phase II work and competitor insights. Lastly, it's important to emphasize that we also have the HRS9821 molecule, which is the first nominated candidate from our ongoing collaboration focused on dyspnea, which is associated with pain during breathing and fits nicely into our cell portfolio since that molecule presents an opportunity to be a DPI administered agent. Finally, I would mention the recent deal we did with Empirico012, which is now called GSK821. That's a long-acting oligo aimed at a broad spectrum, as I indicated. We haven't disclosed the mechanism yet, but will in the future as we gather more data.

Luke Miels, CEO

Yes. 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 a strategic intent here, but we also recognize there is a dynamic element here, in terms of the data that these targets generate, but also the competition gets a vote as well. Ultimately, the long-acting institution, the launch for Nucala COPD in the U.S. is going very well, and I was just there on Monday, where we have around, well, depending on which data set, 43% to 46% of new patient starts already. The market research and the messaging is really resonating. We have transferred all of our new Catareps to Exdensur, and Nucala COPD is being promoted by the Trelegy legacy team. Again, we need to place our bets on the future, and the ultimate future with 5 and higher ROR is going to be long-acting Exdensur for COPD. Shifting to Deborah, do you want to give an update?

Deborah Waterhouse, CEO, ViiV Healthcare

Thanks, Lee. The key thing that I want to reemphasize is that we're on track to select our Q6M treatment regimen in the middle of the year. As I said, we're going to do a meet-the-management event mid-year where I'll lay out a lot more detail about the pipeline. Let me just give you a top line view now. The treatment market is $20 billion in value, with 90% of the value of the total HIV market. Q6M is clearly our biggest opportunity in treatment. We're very confident in the assets that we've got to choose from, and the COI data that we'll present will show just how strong those assets are, particularly VH184, which is a unique, third generation, really potent integrated inhibitor. We believe that to have a really potent regimen, you need to have an integrated inhibitor at the core. So in terms of what kind of studies will start Q6M treatment, you'll see us move into Phase II this year. That puts us on track for our commitment, which is the 28 to 30 launch for our Q6M in treatment. In terms of PrEP, it's a different pathway because with the medicine that we're developing for Q6M PrEP, it's a prodrug of cabotegravir, which we've talked about before. That means we'll be able to go from Phase I to Phase III relatively rapidly, and the Phase I will be starting this year where we’ll progress the dose selection and then we'll do a bridging study from the data we already have from Q2M. Our Q6M pathway is clear, and we are very confident in our ability to deliver against our milestones but don't underestimate Q4. There is a huge desire for Q4M treatment and in Prep. We know that many clinicians are looking forward to opening up their clinic capacity, which will double from what they've got today with Q2M for Q4M. I believe we're going to see rapid cannibalization from Q2M to Q4, and then actually we will likely see rapid cannibalization from Q4 to Q6. In treatment, you see the market really open up as we progress through longer durations between administration. The addressable market for Q2M is about 15% of patients. When we get to Q4M, we get to 30% of patients. Then you've got in treatment with Q6M, 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, CEO

Thanks, Deborah. Julie, quick answer on the other GBP 40 billion. I think everyone knows, but let's confirm it.

Julie Brown, CFO

Yes, sure. Thanks, James, for the question. In terms of what we've included of the recent deals, IDRx has included Efimosfermin, together with the earlier stage Hengrui license and PDE34. Rapp obviously has just been announced, so it's not included at all in the LRF. We continue, as Luke mentioned, to support our BD to build and continue to build the pipeline.

Operator, Operator

Great. Thanks, Julie. Next question please.

Simon Baker, Analyst

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? Then secondly, a slightly bigger picture question for you, Luke. You did mention some facets of your strategy. I just wonder if you could give us a bit more detail on how and in what form we're going to 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 what?

Luke Miels, CEO

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 very clear communication. If it's on track, you'll hear about it. If it's not, we'll call it out. I really want to use these forums for regular updates on our progress and where we're going to. I think these are very effective forums 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 massive experience in oncology and is now responsible for the whole portfolio in partnership with Tony. We've had a number of other members join the team that have been in their roles during this commercial transformation. Many of those individuals have a strong record at Aventus and Roche and AstraZeneca. The aim of bringing them into the team again is just to rebalance and increase the focus on the portfolio, pipeline, and product execution. So with that intro, Nina, over to you on BLENREP in terms of launch uptake and initial feedback.

Nina Mojas, Head of Global Product Strategy

Yes. Thank you. Just checking, you can hear me. Yes. Great. Yes, Simon. BLENREP was launched in the U.S. just at the end of November. We can't really share a significant update based on the sales numbers. What we do know is that we launched in the U.K. in the middle of the year. The dynamic is systematically opening the accounts, 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. Based on the uptake there, we are extremely satisfied. There is huge interest to try Blenrep. We know that we have done good homework in guiding physicians on how to use the drug. Physicians are very much aware of the need for extended dosing intervals to reduce or avoid eye-related side effects. Now translating that to the U.S., we expect a similar dynamic. The timing of opening the accounts is going to take a bit of time, likely longer than what you would see with an asset that doesn’t need that coordination of care. What we did learn from the first launch, we actively educated 18,000 eye care professionals. As an illustration, comparing to the first launch of BLENREP we had only about 5,000 to 6,000 eye care professionals engaged in our program, helping teach how to treat patients. REMS has been a significant factor and has been received very positively. Currently, REMS is not an issue. Physicians are very accustomed to REMS programs and BLENREP is very similar. Currently, we see ourselves scaling up since we want to reach a significantly higher number. Then communicating to the physicians on how to use the drug, the extended dosing is very relevant to enable early positive experience. That's what we see so far. To your question, what can we expect? It's 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, CEO

Thanks, Nina. One other interesting data point is if we look at usage right now for BLENREP, it's about 50-50 between academic and community, which our strategy is to focus on the community. This is encouraging because at this point, you would expect volume to be dominated by academic centers who tend to move on newer things earlier. We can see, to Nina's point, the strategy of focusing on the community, building confidence, and supporting them to dose the first 5 patients appears to be showing promise. We will give you a lot more granularity at the Q1 update, including Exdensur.

Operator, Operator

Next question comes from Michael Leuchten from Jefferies.

Michael Leuchten, Analyst

On for Luke, I noticed reports of a reduction in R&D staff, around 350 people in the U.S. and the U.K. Is this part of a larger program or just normal turnover? If you could provide some context, that would be helpful. Now back to Nina on Exdensur, there are several strategies for launching a product like this, particularly starting with treatment-experienced patients to expedite getting them on the drug, or targeting a naive population to expand the market. Can you discuss the launch curve for 2026 and how we should view this as the year goes on?

Luke Miels, CEO

Thanks, Michael. I'll cover the first question. 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 the areas where we can get the best return, generating assets that are most compelling. Ultimately, in doing this, we will have satisfied shareholders. This is very much an element of accelerating R&D and simplifying how we work. You'll see more of that. We will run the business with great discipline, and where we can see an opportunity, we will rapidly move resources, people, headcount, and capital to support that. Nina?

Nina Mojas, Head of Global Product Strategy

Yes. I can take that. Thank you, Michael. Just as a reminder, we have about mid-20s biopenetration in severe asthma. About 25% of eligible patients now receive biologics. Of those who start on biologics, 65% will discontinue in the first 12 months. This tells you that if we went for an active switch, that business wouldn't last very long because patients are dropping off. We need to look at this in that context. Our main objective is to go for bio-naïve patients. It’s legitimate to expect some switching, and there will be switching, likely from Nucala, hopefully also from other agents in severe asthma. What's more relevant is can Exdensur gain share from patients who would have otherwise started on other agents. There is a huge level of enthusiasm for long-acting 6-monthly dosing, and that will hopefully translate into preferential use of Exdensur over other agents to initiate patients, but then also to start patients who otherwise wouldn't start on biologic yet.

Luke Miels, CEO

Great. Thanks, Nina. The positioning is the first and only biologic that delivers ultra-long protection in 2 doses, and that's landing extremely well in market research and perception. Thanks, Michael.

Operator, Operator

Next question comes from Sachin Jain from Bank of America.

Sachin Jain, Analyst

Perfect. A couple of questions, please. Just firstly for Nina and congrats on the new role. Perhaps a bit more detail on Blenrep. How many physicians have you had through the REMS certification process? 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 midyear. Clearly, we're looking to start the Q6M. I wonder if you will disclose how you think about the financials of that business through the LOE. I guess 2 questions. One, how do you think about the rate of decline of this business relative to where consensus sits? I see Q6M isn't in the midterm guide, do you plan on including it at that point if you start the Phase III? A quick one for you, Luke, just on your Slide 5 and high-level objectives. You've mentioned 2 things. One, simplification, do you intend to have an official cost savings program? Secondly, R&D acceleration, are there any specific programs that you can target for earlier readouts or filing?

Luke Miels, CEO

Thank you, Sachin. I'll address your last question, then we'll move on to Deborah and conclude with Nina. We are constantly looking for ways to save money because it presents an opportunity cost. If we can allocate resources to assets that we believe will offer a higher return and have the right clinical profile to justify that decision, we will proceed accordingly. We will continue this approach in a dynamic and disciplined manner. For areas where we see potential for acceleration, the scale of B7-H3 RR is particularly interesting. The 584,7H4 field is also quite competitive and dynamic, and we’re beginning to identify aspects of the toxicity profile that could give us an advantage. Regarding FGF21, we've evaluated all three companies, and we believe we have selected the best one. While you might expect me to say that, we are confident we can demonstrate this over time based on the frequency of dosing and the product profiles that will develop. These programs, including TCliP and the long-acting TLP, are likely crucial. AstraZeneca is actively working to de-risk the target, and we are confident we have a strategy to advance that asset quickly because it is a compelling area. I believe long-acting treatments can significantly change the way respiratory diseases are managed. Deborah, it's your turn to take it from here on HIV.

Deborah Waterhouse, CEO, ViiV Healthcare

Okay. Thank you, Sachin, for the question. If we think about Q6M first, we intend to set out our HIV story in the middle of the year. At that point, once we've done a regimen selection and we commence with Phase II, we will put that into our long-range forecast, as we always operate when products get to that Phase II phase. You'll see that happen midyear. You then asked about the evolution of the kind of portfolio over time. Let me just give you a top-line view, and we will come back to talk more about this when we set out the HIV evolution in the middle of the year. We've seen a relatively rapid decline of Triumeq as the guidelines have moved away from Triumeq. Over the last 12 months, it's created dynamism in the market, and Dovato has benefited significantly along with Cabenuva. The amount that's sitting in Triumeq and Tpic is now 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 28 in the U.S. and then July 2 in Europe with Dovato and Juluca, having intellectual property coverage now until the end of '29 for Dovato and July 2030 for Juluca. The glide path is coming down. We're already seeing a move away from the old dolutegravir regimens into our newer regimens, and that will continue. We will continue to power forward with Cabenuva Q2M. It's doing incredibly well and growing fast. Apretude has not been dented by the launch of yes2Go. That will continue to grow in '26 and beyond. We will see Q4M, both treatment and PrEP coming in and powering longer-acting forward again until we launch Q6M. Lastly, we've got 2 brand-new molecules with intellectual property coverage, composition of matter patents through to the 2040s. So, you see a dip in '29 and '30 for the franchise as we face into the largest erosion through the exclusivity loss. We then come back out into growth in 2031 and beyond. This growth in that decade is going to be a significant contributor to GSK's success in the 2030s because we're confident in the value that Q6M will offer patients. If that hopefully gives you an understanding of how it will evolve, we will share more detail in the middle of the year. HIV will be a significant contributor to GSK's success this decade and into the future.

Luke Miels, CEO

Thank you, Deborah. Nina, quick answer, then we'll try to squeeze in one more question.

Nina Mojas, Head of Global Product Strategy

Yes, Sachin, thank you for not wanting to ask me for the same number next quarter. REMS hundreds. This is just the beginning.

Operator, Operator

Next question comes from Steve Scala, TD Colin.

Steve Scala, Analyst

Two questions. First on Camlipixant. If GSK needs 2 positive trials to file, which is what the company has said previously, then what's the purpose of the pooled analysis? And/or has the FDA confirmed it will accept filing based on pooled data even if one trial is negative? Secondly, on Shingrix, what were sales to GEFA in Q4? What is your level of confidence in '26 on this drug?

Tony Wood, Chief Scientific Officer

Yes, Steve, I'm not going to get into details of regulatory strategy. What it's giving us is the option to take the approach, both as independent and ultimately pooled studies. It’s worth saying we remain confident in the outcomes for both KALM-1 & KALM-2.

Luke Miels, CEO

Yes, and Steve, there was a shipment in December. We can give 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 6x since the start of 2025. Now it's a low base. We've grown the market share versus Gunway. We now have 93% market share in that population, which is an operational improvement. The strategy has shifted to the one that we launched in Australia and also drove in Germany, and we’re now employing it in the U.S., which is also helping us get traction there. Julie has told me it's $100 million we did at the end of last year. There’s still some stock in the pipe. We’ll give you more color on Q1 but it’s heading in the right direction along with Shingrix in aggregate.