GSK plc American Depositary Shares (Each representing two Ordinary Shares)

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

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

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

Thanks, Deborah. Turning to vaccines, sales were up 2.7 billion pounds in the quarter, up 2%, driven by continued strong demand for Shingrix, Orexi and Dexero, particularly in Europe, which was up 35%. Shingrix sales grew 13% overall, largely due to the strong performance in Europe, up 48%, where we're driving across multiple markets and with significant new uptake in France and a strong performance in Germany, the Netherlands and Poland. In international, sales in Japan continue to grow following the expanded public funding. Ex-US sales now account for around 70% of global Shinguri sales. And in the US, penetration is now 43% of the eligible older adult population, with immunisation rates slowing as expected as we access harder-to-reach patients. In meningitis, our portfolio was up 5%, driven by double-digit growth for Bexera in Europe, where the updated recommendation and reimbursement in Germany continues to pull through. And in France, following a meningitis B outbreak and the implementation of mandatory newborn vaccination requirements, along with new reimbursed cohorts. Also in the quarter, even though the ACIP recommendation came slightly after the back to school season window, we booked the first sales of our penta-valent vaccine, Penmendi, in the US with initial CDC purchases. We expect this vaccine to simplify immunisation schedules and contribute to increased coverage and protection against a serious life-threatening illness. Turning to OREXV, growth was driven by Europe with good commercial progress in Germany, Spain and Belgium. International also grew driven by tender volumes in Canada. And in the US, we maintained our market leading share in the older adults population. However, the US declined due to lower pre-season channel inventory build and slower market uptake in the 60 plus population. In Q3, our flu vaccines were down in part due to competitive pressure in the market where we compete for healthy younger cohort populations who are harder to activate than older adults for flu vaccines. And established vaccines were down primarily due to the prior year impact of our divested brands. So in summary, with the vaccine business, we now expect to land towards the top of our vaccines guidance range of declining low single digit to stable. And as we look forward, although we continue to remain cautious in the near term on vaccines in the US, we are confident in the prospects pipeline and benefit this business offers over the long term. Next slide, please. Turning to general medicines, sales are up 4%, driven by the strong growth of Trilogy in all regions, up 25% in the quarter. And the CIT class remains very strong, up around 23%, driven by gold guidelines, new data, and competitive share of voice. Within the CIT class, Trilogy continues to gain more share than any other brand and is the top-selling brand for both COPD and asthma globally. We also have completed IRA negotiations on Trilogy in line with expectations and our outlook. The remaining portion of the portfolio was stable, reflecting continued generic competition and expected adjustments in rebates and returns. We continue to expect sales to be broadly stable in 2025, and are looking forward to future opportunities in this portfolio, including launching low-carbon Ventolin and further establishing our anti-infectious portfolio through building access in the US for Blue Jepa in uncomplicated urinary tract infections, and also filing Tevye Penn in complicated UTIs by the end of the year. All three of these represent practical innovation for important areas of medical need. I'll now hand over to Julie.

Thank you, Luke, and good afternoon, everyone. Next slide, please. Starting with the income statement for the quarter, with growth rates stated at CER. As already highlighted, sales grew 8% driven by the specialty portfolio across HIV, oncology and RI&I. Core operating profit grew 11%, reflecting a 5% increase in SG&A, as we continue to invest to support key asset launches alongside driving productivity. R&D growth of 10% was driven by accelerated pipeline investment across key specialty medicines. And royalty income benefited from the Cosemptor performance, as well as new RSV and mRNA royalty streams. Core EPS grew 14%, aided by a tax rate of 16% in the quarter and benefits from the share buyback, partially offset by higher NCIs relating to Veve's strong performance. Turning to our total results, the significant growth reflects the Zantac settlement charge taken in Q3 last year. Next slide, please. The operating margin improved 90 bps in the quarter, largely driven by SG&A margin improvement of 70 bps. This increase demonstrates the efficiency gains achieved through our returns-based approach as we invest in new product launches whilst continuing to generate productivity improvements in the promotion of the existing portfolio. Additionally, in the quarter, gross margin improved, reflecting mixed benefits from the continued transition towards specialty. And R&D expenditure increased as we reinvest additional royalty income into our pipeline, supporting the acceleration of the ADC programs and pivotal trial starts for FMS Furman and GSK 981 in second line GIST. Year-to-date, our operating margin is now 33.9%, up 100 bps at constant exchange rates, driven by sales mix, productivity gains and growth in royalties. Next slide, please. Turning to the cash flow with commentary before the one-off impact of Zantac Payments. Cash generated from operations year-to-date was £6.9 billion, improving 1.7 billion, benefiting from increased operating profit, favourable movements in return and rebate provisions, and the CureVac IP settlement announced in August. This was partially offset by increased working capital, impacted by higher RxV and Shingrix collections in Q1 of last year. Free cash flow increased 1.8 billion versus last year, driven by strong CGFO and favourable phasing of tax payments, partially offset by higher spend on in-licensing deals. Zantac payments year-to-date total nearly 0.7 of a billion pounds, and we expect the remaining 0.5 to be paid by the end of the year, drawing a line under the settlement agreed and disclosed last October. Next slide, please. Turning to capital allocation, in line with our framework, we continue to deploy cash in a disciplined manner and underpinned by a strong balance sheet. Our net debt to core EBITDA ratio remains broadly aligned with the end of 2024 at 1.3 times. Our priority is always to invest for growth, as demonstrated by our sustained acceleration of late stage R&D, the next wave of pipeline innovation, and targeted BD. In 2025, we have signed multiple deals, including the acquisition of IDRX 42 and FMS Furman, as well as the Hangrui Licensing Agreement and earlier stage pipeline and platform technologies. We have also made 3 billion in shareholder distributions so far this year through the dividend and the buyback programme, of which 1.1 billion has been executed so far with a cumulative total of 1.4 billion expected to be completed by the end of the year. Next slide, please. As Emma shared, we are upgrading our guidance on the back of the continued strong performance this year. We are raising our full year sales expectations from 3% to 5% to 6% to 7%, with underlying upgrades for specialty, including HIV, and we now expect to be towards the top of the vaccine's range. Alongside this, we're also raising our guidance ranges for operating profit to 9% to 11% and EPS to 10% to 12%. Looking through the P&L guidance, we maintain that gross margin will benefit from product mix, partially offset by supply chain charges of around £100 million to be taken in Q4. SG&A will grow at low single digits for the year as committed, including Q4 charges of around 150 million to fund further productivity initiatives. And R&D continues to increase ahead of sales as we reinvest incremental royalty income into our pipeline. We are upgrading our expectations for higher royalties to 800 to 850 million, supported by income from the CureVac settlement announced in August, and lower net interest costs than previously guided, due to the strong cash generation and the later timing of Zantac payments. Finally, in line with previous guidance, we expect the tax rate to be around 17.5%. In summary, we look forward to delivering a fourth consecutive year of double digit EPS growth, notwithstanding the Q4 charges of around £250 million, demonstrating the successful execution of our strategy since we became a standalone biopharmaceutical business. As a reminder, our guidance is inclusive of tariffs enacted and indicated thus far. We are positioned to respond to these with mitigation actions identified. And looking beyond, we remain very confident in our medium and longer term outlooks to 2026 and 31. Next slide, please. Moving to our roadmap, which illustrates our progress towards major milestones and upcoming value unlocks. We have made good progress through 2025 and we expect to continue to build momentum as we move towards 2026. Over the coming months, we will continue to focus on flawlessly executing the five key asset launches. The FDA regulatory decision for Depimocumab is due this December. And we are looking forward to delivering multiple pivotal readouts across our 15 scale opportunities, including Bepraversin, Cabotegravir, Camlopixent, Depimocumab in eGPA, and Gemperli in rectal cancer next year. And with that, I am pleased to hand back to Emma.

Thanks, Julie. So, in summary, our Q3 results demonstrate the continued momentum in our business, with strong financial performance reflected again in our increased guidance for 2025 and through meaningful R&D progress. Our portfolio continues to demonstrate strength and quality, and we're excited by the prospects in our pipeline. All of this positions GSK strongly for the next phase in the company's development to deliver our long-term outlooks, outstanding impact for patients and sustained value for shareholders. So I'm now going to open up the call for Q&A with the team. But before I do so, of course, we know that alongside questions on our results, many of you will be eager to ask our new CEO designate for his views on the future. Well, Luke and I both respectfully ask that you don't. I am, of course, so delighted and very proud to be passing the baton to Luke, but that is in January. And today we'd like to focus on our Q3 performance. So with that, let's please now open up the call for your questions with the team.

Thank you very much, Emma. The first question comes from Peter Vidal from BNP Faridab. Peter, if you could please unmute yourself.

Thanks, Constantine. Good afternoon. Good morning, everyone. People over here, BNPXN. Two quick questions. Firstly, for Julie or Emma, there's a $6 billion revenue gap between market expectations in 2031 and the GSK revenue target over 40. If we move, then that's obviously a major point of disconnect. But can you just remind us which other assets you believe are being materially underappreciated? And then secondly, I hear you about not asking questions about strategy, which I will, you know, won't go down, but just a factual question for Luke. Is it your intention to either reiterate or tweak the go-forward strategy at the full year results, or do we have to wait for your unveil later in 26? Thank you.

Thanks. Well, I'll ask Julie to just comment on the... difference between our full team shared confidence in the short, medium and long-term outlooks and where the market is today. As we've said before, it is largely in oncology and RI&I. The only other point I would make is that as well as a gap uh between the top line there is also quite a material difference as we've said before in our view of the continued leverage of sgna and where the market currently sits but julie do you want to comment just quickly on that yeah sure thank you very much emma peter for the question

So the major areas, as Emma mentioned, oncology and respiratory, immunology and inflammation, and we do think the data readouts and commercial execution will make the difference here, but clearly the Blenrep launch is one of the areas within oncology I think people are also waiting for the rectal readout in Jen Purley. And then the other difference, of course, is the ADCs recently licensed in from Hanso, which we're very optimistic about in terms of the future. Within respiratory, I have to say the gaps are closing. They've improved. So we've obviously got the DEPI PDUFA date in December this year. People are clearly waiting for that. And then the other one, of course, is Kamla Pixent, where we've got the data readout from Calm this year and then Calm 2 next year. So we think these are going to be the key trigger points that will make a difference between ourselves and consensus.

Thanks, Julie. And, you know, as you pointed out before, it's always we know going to be a combination of the launch execution delivery as well as the data that comes. And it is quite pleasing with our upgraded guidance this year as a reminder that our initial outlook of 33 billion to be delivered by 2031. We are well on track to be delivering this year, six years early. So, Luke, the second part of the question was related to what's coming, despite our shared requests in the closing, what's coming for 2026. And as usual, We are not going to give a huge amount of detail now about what's coming in 26, but we do want to all as a team reiterate our very high confidence in those not only 26 outlooks, but also 31 outlooks, which are forecasted by this team and committed by this team, as you've heard us all do together again today. At the beginning of 20, with the full year 25 results, you'll hear the outlook for 26. And then later on in the year, the building blocks to delivering that longer term 31 outlook. But Luke, I know you don't want to say too much, but is there anything else you'd like to add to that?

Sure. Thanks, Emma. Thanks, Peter. Look, what I'll say is, look, the number 40 is doable and I stand behind it. Look, the majority of the products in it were forecast by me.

Right. Well, that's clear. And you'll hear more next year. So next question, please.

Next question comes from Matthew Weston, UBS.

Thank you, Constantine. Two questions, please. The first for Luke on Shingrix. There was a great benefit ex-US from the rollout in France, both in Q2 and Q3. Can you give us some help for the pushes and pulls on Shingrix into 26? Should we assume that there's been a France bolus, which wanes next year, and then we need a geography to take up the baton? If so, which one? Or do you think there's just consistent rollouts, which mean Shingrix XUS can keep growing? And then a second one for Julie, another quarter of great margin leverage. I know this, I promise it's not really a 26 guidance question, but can you at least help us with pushes and pull on X? So obviously a statement about R&D reinvestment in 4Q, how much should we assume that carries on? But also Depa Mocumab, Newcala COPD and BlendRep launches. Should we think of S&A needing more next year?

Right, so Luke first on Shingrix and then Julie on our continued drive for meaningful SG&A leverage, please.

Thanks, Matthew. I mean, the short answer in Europe is yes. I mean, if you step back, We've quietly pursued a three-state strategy, and I've mentioned this on multiple quarterly earnings calls when Shingrix has come up in line with the current label. The first step, of course, was max the US and get to a point where we've penetrated and where that starts to slow. So we've got an immunisation rate of 43%, which is in line with the 3% to 5% increment that we'd signalled. It's very much linked to flu, though, and flu is softer. um and then the plan of course was uh within the us which we started to pivot on to focusing on the comorbid high-risk subgroups and that's just started now in june and i think the results are encouraging uh maybe with hindsight we could have gone there earlier but uh again we're getting traction there uh so that's that's a good sign uh but the us will still be tough um because the sort of macro factors around vaccines which uh no doubt we'll get into later In Europe, I mean, really the strategy was to maintain pricing discipline and then build the evidence for the launch in Europe and Japan, and that's exactly where we are now. So the average immunisation rate in the top 10 markets ex-US is around 10%. It's about 9.7% to be exact. So there's more opportunities, more work to do as we broaden those populations in those countries. And then the third part, which we're really not in yet, is a pivot to the emerging markets in the midterm with more pricing flexibility. You know, we did start, they were trying to have a bit of a a challenge there. But we've got a pathway, again, focusing on comorbid, and that is resonating despite a tough backdrop. So it's very much a midterm story with China and emerging markets. But, yeah, net-net, I think we're in good shape with Europe, and we just need to keep that going.

Great. Thanks, June. Thank you very much. Thanks for the question. In terms of, first of all, we're confident in reaching 26 margin target that we laid out for more than 31%. To your point about investment in R&D, we have deliberately been putting more investment behind R&D now for a number of years. And we expect the same next year that R&D will grow ahead of sales. And then in terms of the investment in the launches, we are totally investing in the new launches. We're here to grow the business. So definitely investment gone already into Blenra. Depomocumab coming up, etc., and Eucalyptus COPD. These are big areas of investment. The thing that we're doing in parallel, as you've probably seen, is that we are driving productivity benefits also through SG&A and the gross margin. And basically, we're looking at operating model cost and tech to modify and simplify costs. what we do. These are really important components. And we now have a track record of doing this. You know, we've guided at more than a 31% margin by 26. This will be over 500 basis points of accretion for the company between 21 and 26, which is really a considerable achievement, as well as funding those launches.

yeah and as i said i think um we we all expect that to continue i mean just don't underestimate how much technology is changing the way you can effectively and efficiently uh do sales and marketing work very differently than you know it has been the history of this industry and we're all seeing that change happen uh whilst allowing us to invest very competitively behind the launches um that you know you're considering continuing to see us deliver competitively on

Next question, please. Next question comes from Michael Leuchten from Jefferies.

Thank you. Thank you. Two questions for Luke, please. One for DepeMokeMap with the pending approval. Luke, can you update us on your latest thinking on phasing of access, likely source of business for the product into 2026? And then LENREP, there's been a lot of debate after the approval on label, scope, REMS and the like. Is there any learnings you can point to from the, albeit early experience in Europe or small experience in Europe that helps us understand sort of how the shape of the curve could look like in the US? Thank you.

Thanks, Michael. I mean, I'll start with Blenrep first. Yeah, I think there's a number of lessons. I chair a task force every two weeks to look at this to ensure cross-functional learnings, and we're certainly incorporating those. I think the key, again, no surprise, is that once people have experience with this product, they tend to be, how would I say, pleasantly surprised by by the reputation leading into this versus the experience of using it. And that's why we've been very focused on supporting physicians with those first five patients to ensure that they understand the dosing and how to manage that and how to hold doses and integrate that into their practice. And that's everything that we will then take into the US. We also have close to 8,000 patients now who've been exposed to Blenrep globally. So we've got a lot of clinical and operational experience in those centres as well. Look, it's obviously a competitive environment right now, so I'll be careful around some of the phasing around access to our strategy there. But what I will say is, you know, I think this is quite a fascinating opportunity. You know, the basic facts when I try and look at that to simplify things is that you've got a lot of... eligible refractory patients who, by definition, are at risk of exacerbation. And in the US, access is actually extremely good for all biologics. Yet the conundrum, the paradox is that only 27% actually get a biologic. And then I think a few physicians must scratch their heads on this one. Those that do get a biologic, you know, We see this with our data. It's true with Dupixent, Facenra, et cetera. After 12 months, you're losing around two-thirds of them. And, of course, if you're not adherent, you are put on a biologic for a reason, and if you're not adherent, then you have a higher risk of an exacerbation and subsequent ER visit, for example. You know, for us, there's a clear opportunity here for ACP driven administration with long intervals between dosing and a strong efficacy that's associated with that. The market research is very, very consistent. This is probably the most market research product in GSK. And 86% of pulmonologists say this could be a new standard of care when we show them the target label. And 82% of pulmonologists said they would consider using this product ahead of other MOAs. So our strategy is very simple. It will be focusing on the naive new patients that are first going on to biologics.

I think this is just an extraordinary opportunity when you see the material difference in compliance the material reduction, 72% reduction in the kind of attacks that cause hospitalisation. And consequently, the very significant cost-sparing benefit for healthcare systems in such a scale disease as asthma. And then, of course, we're very excited about taking DEPI into COPD and other indications too. Next question, please.

Next question comes from Luisa Hector from Bernberg.

Hi, Louisa.

Hi there. And maybe I could take this chance, Emma, end of an era. So thank you on behalf of all of us. Many insightful conversations and I think many significant achievements whilst navigating some of the challenges. So thank you very much. And my questions would be on business development, because we've seen a very neat series of small deals. So where are we now in terms of appetite capacity for the next round of deals and any changes in terms of size or area phasing, etc.? ? And perhaps a quick check on the comments you made on J&J and Rilpivari. Should we assume that they can now supply everything you need and that this would not be any kind of constraint when you get closer to filing and launch? Thank you.

Right. Yeah. I mean, I think we are really supremely confident in our long acting portfolio, both because of the momentum in the business and the prospects in the pipeline. I'll ask Deborah to talk about that. And in terms of BD, look, and, you know, once again, Luke and Tony and David have been all been co-architects of some deals that we are extraordinary. pleased with their progress on. It's great to see three out of the four phase three or the pivotal trials that are due to start at the end of this year are from deals that we've been very pleased to sign. We're thrilled with the discipline we've put through in terms of value and returns when we look at these deals, whether it's in the what's become more fashionable FGF21 market or indeed our ADC plays or of course that We're very excited to see what's going on in terms of pipeline development in China and thrilled to see where that partnership with Hungary will do. And then, of course, once again, we added a couple more deals just this week in our earlier stage pipeline because, you know, we're all very focused and you're all very focused on the models of what's happening with the Core 15. you know i know how much the team are also thinking about that next wave of development through the 2030s when we come out the other side of successfully digesting a dollar tag of it so i think you should expect um that bd will continue to be a very cool it's about half of our pipeline and it will continue to be a very material contributor to our pipeline with the focus on orion ion and you know the kind of scale and pace but we're always going to be looking out at things and review it very very regularly and obviously the market stays competitive and we're right in the middle of that so not much more I think to add on that but let's get back to long acting now a third of our 30% of our business in the US already so Deborah do you want to talk about that in the pipeline question

Yeah, thanks, Emma. So just to start, delighted with the Cabinuva's performance, 75% growth in the quarter. And actually 75% of our Cabinuva switches now come from competitors. And our long-acting injectable performance is at the heart of why we've been able to upgrade our HIV guidance this quarter. So let's just talk a little bit about Q4M. So our Q4M Quattro Phase 3 study start is going to be delayed into H1 2026. And that's due to a delay in the delivery of recovery and clinical trial supply by Janssen. There is no ongoing issue which would cause us anything but complete confidence from Janssen. They're a great partner. This is just a one-off I think the key thing to communicate is that this is a clinical trial. Supply delay is not related to efficacy or tolerability concerns at all. And we remain committed to 2027 to file and 2028 launch of Q4M. We've looked over the financials and there's no material impact on Outlook from the delay because we've got Cabanova in the market already. And that product is performing so well. Demand is high. We've got really fantastic momentum. And whilst we're disappointed, obviously, not to be able to launch Q4M at the end of 2027. As we originally said, actually, this is a marketplace where there's no competitor for a long, long period of time. So we are the only long acting injectable in treatment and we're going to remain that way for the foreseeable future. Cabinuva will power on and we will do everything we can to get Q4M into the marketplace as soon as we can. And then obviously we've got Q6M coming next. year we will be doing our regimen selection for q6m and then we will be launching that asset as the next phase of our long-acting injectable journey it's just so important to remember that we are the only one on the treatment market for a very long time ahead and that is a business that you know continues uh to to accelerate momentum so And there are obviously, you know, as we've seen ourselves, some sort of bumps in the road of long-acting injectables that we and our competitors experience. So I think it's just a complicated area, mainly around CMC, but in terms of the patient benefit, really significant, and the demand from patients is also very material.

Yeah, definitely want to keep watching. Next question, please. Next question comes from Sachin Jain from Bank of America.

Sorry, can you hear me now? Sorry for the delay. Just to follow on actually to the Q4M question. So thank you for that update, Deborah. But one of you could just talk about the commercial impact of delay relative to gilead's weekly oral uh lenny's natural which is probably six to twelve months ahead we hear mixed um kol feedback on weekly oral versus uh q4m uh secondly um i wonder if you could just update on u.s policy so any color you're willing to give on ability to do a deal with administration given your high medicaid exposure and then how's dialogue around ira uh going and then just one quick clarification if i can chance my arm for luke as a follow-on to earlier question on Blenner at DEPI. Clearly bullish commentary, Luke, but just trying to triangulate it versus 26 consensus for both, which is around 200 million. I know it's a tough question, but any colour direction would be helpful. Thank you.

Luke, do you want to say anything on that?

Look, I would just say these are big assets in the long term. I can't give any sort of color, but we're going to approach both assets very aggressively.

And I would just point to the performance in New Cala COPD, where in May we had 0% market share and we've now got 46% of those new patients. in COPD against Jupixent. That's not a read-across step in MochaMap. It just tells you that the team is very effective at executing and we're going to be, you know, focused on that asset and blend already in the field and receiving very good feedback. Again, it's going to be more of a stage process to give people experience and confidence to use the product more broadly.

Right. So on MFN, you know, I'm not really going to give any more detail or get ahead of anything, except to say, as you would expect, we're engaging, as I've said, very constructively with the administration. Medicaid is 10% of our total US business. I'm really confident in our ability to navigate this over the last, four years through a variety of different environments, the strength and quality of our portfolio has continued to allow us to do repeated upgrades and navigate through these kinds of challenges. The US is our number one priority market. We've committed to very material investments there, and we fully agree that we should be partnering and working towards being in a place where Step change innovation can be made, you know, affordably available and sustainably available for innovators to American patients. And we also fully agree that we'd like to see all countries recognize the value that innovation can bring. bring to bring down the demand care on health care. So the demand curve and therefore the costs on health care. So, you know, continue to engage here and and we'll keep you updated. And, you know, very much bearing in mind and sits with a strong underpin to our confidence on our outlooks overall. You mentioned IRA. I think Luke already said it. We're very pleased to have concluded the latest rounds of IRA negotiations and all fully factored into our outlook. So nothing more to report on that. And on Stebra, I think that is an important point. I want to remind people.

Yes, thanks, Sachin. So there is an expectation that LEN plus Isolatrevia were launched in 2027. All of the research that we have done indicates that the once weeklies will cannibalise other orals. And actually there is, on that particular asset, a bit of a mixed view. Firstly, because of the history of Isolatrevir and the CD4 depletion. But secondly, I mean, we absolutely believe that you need to have an integrase at the core of any two-drug regimen, whether it is an oral weekly or a long-acting injectable. Because integrase have got incredible potency, tolerability, high barrier to resistance. And 78 percent of those people who are on treatment today are on an integrase inhibitor because they are the cornerstone of HIV treatment. Now, we know that obviously the other once weekly from our competitor, which is the pro drug of Len and an integrase inhibitor inhibitor. is on clinical hold. So again, you've just got the isolatravir plus the lenacapavir option in 27, and we don't think that's going to be a challenge to our Q4M, one, because long-acting injectables is a very unique value proposition, two, because we've got an entity at the core of that particular regimen so we're feeling very confident about our ability to keep driving our hiv business forward uh and growing strongly and helping dsk navigate through the loss of exclusivity of dollar tigger bear thanks next question please next question comes from simon baker from redburn hi simon

Good morning, everyone. Sorry, it just took a little while to unmute there. Thank you for taking the questions. Two, if I may, please. Luke, going back to something I asked you on the BlendRep call on Friday, around the 2031 target. Back in 21, you gave a number of peak sales estimates for products in RSV, BlendRep, Zedula, and Gemperly. You've reiterated the 40 billion target. I just wonder if you could give us thoughts on the pushes and pulls. You always said that there were a lot of factors going towards the aggregate figure, but just a check on where you see the pushes and pulls there would be very helpful. And then for Deborah on HIV and the Q4 slight delay, that pushes it a little bit closer to the Q6 launch, but not materially so. So I'm guessing you've always thought that it's not one duration fits all. I just wonder if you could give us some thoughts on how the long-acting market will pan out with the various injection duration options that you will be offering. Thanks so much.

So I'm going to come to Deborah first on this, but also, and I will turn back to Luke, but just to be clear, as we've already said, it will be the beginning of next year when Luke will give an outlook for 26, and more likely much later in the year when he will talk about the building blocks to deliver on more than 40, and his more than 40 in 31. So I just want to give Luke the permission not to get into details. of the ups and downs as the portfolio continues to mature. But Deborah, let's come to you first. And Luke, if you want to add anything to that, then I'll let you.

Thanks for the question, Simon. With Q2M, 15% of patients would be willing to take that regimen to treat their HIV. When you get up to Q4M, it doubles to 30%. And then when you get to Q6M, half of the people who are living with HIV in all of our research say that they would be willing and keen to take regimen. a six-month long acting injectable within the research though and with physicians too you are right some people say actually i would like to give q4m to my patients on an ongoing basis because i like to pull them back into the doctor's office three times a year to have viral load testing um sexually transmitted disease testing and all the things that they do to care for their patients. Others are very keen to see that their patients go to Q6M. So there will not be one size fits all, but what there will be is a market expansion that is significant as we extend the duration between administration from two to four, four to six. And obviously when we get to Q6M, it's a brand new set of medicines because you've got the third generation integrase inhibitor, VH184, which has a unique resistance profile and is a third generation integrase inhibitor. And then you have a capsid inhibitor or N6LS, depending on which regimen we select. for our Q6M, and it's great to have options. So feeling very bullish about the future of Q6M, but also see a place for Q4M as patient choice remains critical. Thanks, Deborah.

Luke, any comments you want to add?

Thanks, Simon.

I mean, I would just say, again, confident overall in the late-stage assets. And, yeah, look forward to updating everyone with the team next year. In terms of blend rep, I mean, it's going to be material. I've said that over the next couple of years. And the key is obviously the initial launch and then the pathway and the second line, which Tony is very much at hand, and the usual pushes and pulls with competitive data sets.

Thank you.

Next question, please.

Next question comes from Sarita Kapila from Morgan Stanley, please.

Hey, thanks for taking my question. Thanks for the colour on you, Carla. I was just wondering if we could have a little bit more on the rollout in COPD, how the launch is going versus your initial expectations and where you're seeing the most use. Is it in the 150 to 300 assinifil group or is it in the over 300s where it would be more head to head with Depixent? And then the second one on Gemperley, please. It seems to be a very strong rollout in the US or momentum in the US. How penetrated are you now in endometrial cancer and is this momentum sustainable into 2026? And should we think about Gemperley being able to get your guide of over 2 billion in the existing indications or would you definitely need the pipeline to hit that? Thanks.

So we'll come to Luke on both Nukala and Jen Purley, but I think it would be good as well, what we've heard on the Nukala launch, just to hear a little bit from Tony, because I think we are all, well I know, we're all getting more and more ambitious on the portfolio for COPD, whether that's DEPI or the other companies. that we're bringing forward. You know, I know when we announced the deal we just did, the statements that it's going to be the leading cause of hospitalisation in coming years. And we're talking about hundreds of millions of people. So this is really a scale disease where we have a lot of expertise for the pipeline coming forward. But in terms of what's at hand right now, do you want to comment on you, Carla? Yeah, I mean, thanks, Sarita.

It's broad. I mean, when I was talking to the... the BU head in the US about this. He said broad several times. Broad label, broad uptake, broad resonance. Another market research point that's interesting is 9 out of 10 US pulmonologists strongly agree that preventing severe exacerbations is essential to COPD management. I'm not sure about the 1 in 10. I don't suggest you go and visit them. Yeah, clearly it's landed well. But as I've said on other calls, you know, this is a population of prescribers that only use it in one in three patients for many reasons. So that is just a balance in caution. But how we're going against dupixin is very encouraging. Yeah, and it's a label both bronchial tetic, it's emphysemia and different EOS levels.

Great, thanks. Just moving on and on, Jen, thoroughly. In terms of endometrial, obviously, we're pleased that we have the only and first label with dual primary endpoints, PFS and OS in endometrial cancer. We're following that up with a study called Domenica, which is looking at evaluating gemperline in a chemo-free way. Ray Sherman. Importantly, as well, obviously, the rectal studies continue to progress. We have fantastic, complete responses. Just a quick reminder on some of those programs for you as you're one, which is the locally advanced MSI high rectal results, which we're expecting to read out in the second half of the 26th. ASIO2, which is colon cancer, and there's an interim for that in 28. And the JAID study, which is in the unresectable head and neck setting, for which we're also expecting readouts in 28. So lots of momentum going around Gen 30 to continue to support the growth of that medicine.

Anything you want to say on CPD?

On COPD, look, I'm delighted with where our COPD portfolio is currently sitting. You may have noticed we have now three phase three studies starting in COPD. There are the Endura 1 and 2 studies in the more typical. COPD population, and a study called VIGILANT, which is looking at earlier COPD patients. These are individuals who are not treated typically with BIOS, but for which they have secondary factors that predispose them to rapid progression. Coming along behind all of that solidly is the long-acting T-slip and IL-33 options, and as Emma has mentioned, the Ongui option in PD34, and the latest deal that we have with Empirico that was announced this week with regards to an entirely new novel mechanism, which is olivobased.

Yeah, and to read it back on your question on gemperly and endometrial, I mean, I think the good news overall is if you just look just in the last 12 months, you've gone from, you know, 80% of ONCs using IO typically and endometrial to now 96%, which is great. You know, 90% of these patients are now in some form of IO. For us, there are clear opportunities if a physician can accurately cite the Ruby overall survival criteria then their likelihood of using the drug is double that versus someone who can't. So that's our focus is the DMMR population. We do have the broad label, of course. MMRP tends to be more dominated by Pembroke, but globally there's about a 5% difference in market share in our favour against Pembrolizumab, which is very encouraging.

Yeah, lots of words coming on. Next question.

Next question comes from Zain Ibrahim from JP Morgan. So, hi.

Hello, thanks for taking my question. This is from JP Morgan. So my first question is on Blenrep, and you talked about it, but you mentioned you expect to see a material growth driver over the next three to four years. So how much of that growth do you expect to come from the US based on the current label versus ex-US, and how much of that is driven by the expected indication expansion in 2028? That's my first question. Then my second question is this from General Medicines. Sounds like the trilogy IRA negotiation was in line with your expectations. So how are you thinking about the development of general medicines over the midterm? Thank you.

Yeah, I mean, on GenMed, we're not going to change our 21 to 26 guidance, which we upgraded slightly because of the operating performance. So there's no more update on that. And I'm not sure, Luke, how much you want to itemise. I know Darzalex is about half X.

Yeah, that's right, Emma. I mean, I think, look, the priority is to get to second line in the US to match the rest of world label. The US initially will be ahead of Europe because we're launching ahead. But as markets like Germany and Japan come online, that should balance out in open time.

Yeah, and I think as Luke and Tony went through in a great deal of detail on the calls, there is a material opportunity in third line and we have a good pathway to getting to second line. And in fact, you know, studies plan, as you all know, in first line too. So, you know, I think this is definitely one to watch as part of our broader oncology portfolio, which continues to build. So I just want to say one last thing, because I know that was our last question. And we went because we had a technical issue, I think, at the beginning. So apologies if you were made to wait. You know, you do know this. I know this is my last call to report as CEO. And I do want to just take a moment. To thank everyone on this call for your time and engagement with me and most of all with this tremendous team who over the last nine years together have transformed our great company's performance, pipeline and prospects. And in doing so, we've set out a clear pathway for patient impact at serious scale, already 2 billion people around the planet. And I firmly believe that GSK's value for shareholders will be fully recognised and sustained. When you step back and reflect, it's really hard to think of a sector that matters more than ours, where innovation and trust really can change people's lives and drive sustained performance and value for shareholders. And all of us, whether it's those of us here in this room or everybody on the call, well, we're all part of a really extraordinary, incredible industry. And it's a privilege to be part of it. And it is not a responsibility to leave lightly. I am so delighted and very proud to be passing the baton to Luke and to be leaving all that GSK has to offer in such fantastically good hands. So I just wanted to finish up for the last time, wishing everybody listening in just great good fortunes for the future. And I, of course, look forward to cheering Luke and all the wonderful people working at GSK to a lot of further success as they combine science, technology and their talent to get ahead of disease together. Thank you all very much.