Ladies and gentlemen, a very warm welcome to the GSK Q2 2025 Results Call. I'm delighted to be joined today by Emma Walmsley, Tony Wood, Luke Miels, Deborah Waterhouse and Julie Brown, with David Redfern joining for Q&A. Today's call will last approximately 1 hour with the presentation taking around 30 minutes and the remaining time for your questions. [Operator Instructions] 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 Emma on Slide 4.

Thank you, and welcome to everybody joining us today. Please turn to the next slide. Our second quarter results once again demonstrate GSK's strong performance momentum and the quality and strength of our portfolio. Group sales were up 6% for the quarter. Core operating profit was up 12% and core earnings per share grew 15% to 46.5p. Sales growth was driven by our largest business, Specialty Medicines, up 15%; and vaccine sales also contributed with sales up 9% in the quarter. This led to increases in profits and earnings, which also benefited from a strong focus on SG&A. Alongside operating performance, we continue to make good progress in R&D with 3 FDA approvals achieved so far this year. Cash generation also remains very positive with GBP 3.7 billion generated in the first half to support further investments in growth and returns to shareholders. The dividend for the quarter was 16p, and we've now completed more than GBP 800 million of the share buyback program initiated in February. All of this is underscored by our commitment to operating as a responsible business. Our most recent action being to expand our voluntary license agreement with the Medicines Patent Pool to now include long-acting cabotegravir for treatment of HIV as well as prevention. And finally, driven by our strong performance, we're confirming today that we now expect to be towards the top end of the financial guidance given for 2025. Next slide, please. Following the demerger of Helion, we made a commitment to drive a step change in performance at GSK. This quarter has again shown that GSK is delivering consistent sales growth, operating leverage and positive financial performance. The investments and development choices we made in our portfolio, notably to launch new Specialty Medicines have really helped to drive these new performance…

Thank you, Emma. Next slide, please. Our #1 priority in R&D is to develop transformational specialty medicines and vaccines in areas of high unmet need that positively impact health and deliver significant growth. This is evident in the 14-scale opportunities we have for launch before 2031, and in the progress we're making to expand and accelerate our early-stage pipeline of first and best- in-class assets. We remain focused on 4 core therapy areas, enabled by advanced technologies, talent and a network of world-class partnerships, and we continue to deepen our expertise in the science of the immune system. This is most recently exemplified with our work to develop IL-5 medicines for lung diseases, which is providing us with a better understanding of the role of the immune system in fibro-inflammation, leading us to target diseases beyond the lung towards kidney, liver and with the potential future application in neuroimmunology. Next slide, please. Based on decades of research, we have a unique understanding of the role that inflammation plays in chronic airway disease. Our focus on the underlying biology of inflammation, notably in COPD, has led to a differentiated pipeline of long- acting options, each strongly supported by human genetics disease phenotyping and insights from our own scaled clinical trials. In May, we received FDA approval for Nucala for the treatment of COPD. This is the fifth indication for Nucala in the U.S. We've also filed depemokimab, our novel ultra-long-acting IL-5 antagonist for the treatment of asthma and chronic rhinosinusitis with nasal polyps with regulators, and we have a PDUFA date of 16 December. I'm also pleased to report for the first time today, positive results from the AGILE continuation study which further underscore the sustained efficacy and safety over a 2-year period of twice yearly depemokimab. AGILE is an open-label…

Thanks, Tony. Please turn to the next slide. In Q2, we delivered GBP 8 billion in sales, up 6% versus last year, demonstrating strong execution and demand-driven growth. Growth in the quarter was driven by Specialty Medicines, up 15% and strong Shingrix and Meningitis demand in Europe, with some offset driven by the expected impact of the Medicare Part D redesign across the portfolio, which is tracking as expected. Next slide, please. Specialty Medicines continues to be the most important of our diversified business with double-digit growth once again in all therapy areas. Starting with RI&I, sales were up 10%, even with the expected tough comparators for Nucala and Benlysta, and this was driven by strong demand. Benlysta, our treatment for lupus grew 13% and is now positioned as a preferred therapy in all global guidelines. And in the quarter, EULAR also updated their recommendation for use of Benlysta up to 3 years following remission. And Nucala, our anti-IL-5 biologic grew 7%, in line with expectations following an inventory build in quarter 2 of 2024, and the impact of Medicare Part D redesign, both offset by a strong performance in Europe and international. We are very pleased with the label we have in COPD, which I'll cover in a minute. Moving to our growing oncology portfolio, which was up 42%. Jemperli for endometrial cancer continues to see increasing patient demand and growing market share in both dMMR and MMRV populations, following a all-comers approval in the U.S. and Europe, up 91% in the quarter. And Ojjaara sales were up 69%, driven by strong U.S. volume growth, including growing demand from moderate anemic patients that represents 65% of the market opportunity. And Blenrep had its first sales in second-line multiple myeloma following early launch days in the U.K., and more on…

Thank you, Luke. Our HIV portfolio continues to deliver exceptional growth of 12% in the quarter. 9 points of growth came from strong patient demand for our long-acting injectables and Dovato, and 3 points came from customer stocking patterns and tender phasing. We saw demand grow across all regions and major markets, particularly the U.S., which grew 14% through double-digit demand growth and where we saw not only total share gain outpacing the competition, but Cabenuva consistently gaining at least 70% of product switches from competitors. Dovato continued to deliver strong performance, up 23% and our long-acting injectables, Cabenuva and Apretude delivered robust growth at 46% and 50%, respectively. With treatment accounting for 90% of the total GBP 22 billion HIV market, we continue to drive the shift to longer injectables. In Q2, Cabenuva and Apretude delivered more than 70% of our total growth driven by the U.S., where they now account for 1/3 of sales. Focusing on long-acting injectables for treatment, strong patient preference is reinforced by Volition, a Phase IIIb study shared at the IAS conference this month, showing nearly 90% of newly diagnosed people chose to switch to Cabenuva from daily pills after achieving viral suppression. This medicine continues to transform the lives of more than 90,000 people living with HIV. Apretude saw strong growth in the quarter, and we expect it to continue to grow in H2 in the U.S., bolstered by over 3 years of real-world data, demonstrating more than 99% effectiveness along with excellent safety and tolerability across broad populations. We have set a high bar for tolerability with Apretude, given by 1 shot intramuscularly. This quarter, we initiated the Phase I CLARITY study in healthy volunteers to evaluate the tolerability of a competitor long-acting injectable against Apretude robust profile. We are very optimistic…

Thanks, Deborah. Turning to Vaccines. Sales for Q2 were GBP 2.1 billion, up 9%, primarily driven by strong demand in Europe for Shingrix and our meningitis vaccines. Shingrix sales grew 6% in total, as our global expansion strategy is delivering with 72% of our sales now coming from outside the U.S. Growth was driven by launches and national immunization approvals in countries like France and Japan, and we remain confident in the ex U.S. opportunity. Starting in Europe, Shingrix sales were up 48%, led by swift uptake in France and strong demand across several countries, including Spain, the Netherlands, Italy and Greece. In the U.S., penetration is now 42% of the eligible older adult population, achieved in about half the time it took for older adult pneumococcal vaccines. And with harder-to-reach patients, the immunization rates have slowed as expected. And in international, accelerated uptake in Japan following expanded public funding in April was offset by a tough Q2 2024 comparator, which included supply to our co-promotion partner in China and a rapid uptake in Australia. In meningitis, our portfolio was up 22%, with strong double-digit growth across Europe and international, driven primarily by Bexsero, the only MenB indicative for infants. In the U.S., where we have dominant leadership in the MenB adolescent market, we're excited to introduce our pentavalent vaccine Penmenvy. We expect this vaccine to simplify immunization schedules and contribute to increasing coverage and protection against serious life-threatening illness. Turning to Arexvy. Obviously, we are preseason, but Arexvy sales increased 13%, maintaining market leadership in the U.S. older adult segment and benefiting from strong uptake in Germany. In the U.S., we're also pleased to see that earlier this month, the CDC confirmed the ACIP recommendation for adults aged 50 to 59 at increased risk. In the current vaccines environment,…

Thank you, Luke, and good afternoon, everyone. Next slide, please. Starting with the income statement for the quarter with growth rates stated at CER. GSK continues to build momentum in 2025, with sales increasing 6%, driven by continued strong Specialty performance complemented by growth in Vaccines. Cost of sales for the quarter grew 7% ahead of sales due to pricing impacts and supply chain optimization charges. Core operating profit grew 12%, with strong leverage in the quarter, delivered through a 1% reduction in SG&A, demonstrating our disciplined returns-based approach, and a 70% increase in royalties due to the upfront receipt from the IP settlement announced in April. Core EPS grew 15%, continuing to demonstrate our track record of delivering margin leverage and enhanced by lower interest charges as well as the share buyback. Turning to total results. growth of 33% was largely driven by a favorable ViiV CCL movement, predominantly due to currency, partially offset by intangible asset impairments. Next slide, please. This chart illustrates the margin improvement year-on-year. The operating margin improved in the quarter by 180 basis points, driven by SG&A and royalties. Whilst we continue to invest competitively behind product launches, SG&A improved the margin by 190 bps due to phasing between the quarters and accelerated productivity improvements. As I mentioned, royalties were driven by the RSV IP settlement, the income from which is being reinvested in R&D this year with priority projects accelerating this quarter. Finally, on whilst the portfolio and margin continued to benefit from the transition towards Specialty, the Q2 fall in the gross margin was predominantly driven by lower RAR benefits year-on-year and by charges associated with supply chain optimization. Next slide, please. Turning to the cash flow with commentary before the one-off impact of Zantac payments. Cash generated from operations were GBP…

Thanks, Julie. To summarize, our results today confirm GSK's continued strong momentum and meaningful R&D progress for patients and for shareholders. Our portfolio is demonstrating quality and strength, and we now expect to be towards the top end of our financial guidance for 2025. Looking beyond, we're excited by the prospects in our pipeline and remain highly confident in our long- term outlook. With that, I'll now open up the call for Q&A with all the team.

[Operator Instructions] First question comes from Simon Baker.

Yes, 2 questions, if I may, please. Firstly, just a clarification on camlipixant. Tony, you said they would both report in 2026. Slide 32 is still showing CALM-1 readout in H2 '25. So when you said report, do you mean the full data, and we will still get a CALM-1 headline press release in 2025. And then the second question was related to Blenrep. We, like you are assuming, this is simply a potential delay rather than anything else. So I just wanted to get your thoughts on what impact that has, firstly, on 2031 and the composition of the GBP 40 billion if those Blenrep revenues are pushed out slightly. And also, what it means for 2028, where the contribution from Blenrep now looks like it will be smaller, and therefore, the impact from the dolutegravir patent expiry will be greater. Just how that -- what the magnitude of that is? And also how that influences your M&A plans going forward?

Thanks. Well, I'll ask Tony in a second, just to comment quickly on camlipixant. But to be really clear, Simon, we are very pleased to have an updated PDUFA date in October. There is absolutely no change to our expectations around the ramp of Blenrep. We're really pleased with the -- we're hoping to get into more than 10 markets actually by the end of this year. We're working hard and constructively with the FDA to be able to bring this to American patients, too. So no change. I'm fully confident whether it's our '28 outlook or '31 outlooks. And as you know, we keep adding to them with new prospects and ongoing BD. And specifically on your question on BD, it's quite exciting to me that 3 of the 4 pivotal trials that are starting later this year, whether it's on efi or IDRx, or our next-gen of ADCs are from a great BD that we brought in. Of course, we announced Hengrui this week, which is a really strategic play to accelerate early stage research and with a headline assets, which might be best-in-class on the PDE3/4 for COPD as well. So lots going on in BD. And we'll continue at the kind of pace and scale we have been. But no update at all, except for reiterated confidence in terms of our outlook and plans to add to them. Tony, anything you want to say on camli?

Yes. Simon, thanks for the question. And just as an update, and clarifying here, as I said before, CALM-2 is still recruiting. We're anticipating data in midyear '26. You'll also appreciate that typically, we only disclose Phase III studies involving 2 studies once both are completed. And so the formal disclosure associated with CALM-1 and CALM-2 will be in line with the CALM-2 schedule.

Next question comes from James Gordon from JPMorgan. James, please go ahead.

James Gordon, JPMorgan. First question was also on Blenrep. So a busy few weeks with the ODAC, and then it sounds like subsequent data added after the ODAC and then some personnel changes at FDA with Vinay Prasad leaving. So without asking what the extra data is, just what is GSK's latest confidence in getting Blenrep approved in the U.S. this year, and also is -- how important is Blenrep U.S. in keeping the margin flat through HIV LOE starting in '28. So if you didn't have U.S. Blenrep, would you still be able to keep the margin flat? That's the first question, please. And then the second question, the PDE3/4 looks interesting for the Hengrui deal. So I think based on like $10 billion to get Verona's PDE3/4, but that is already in the market, and you're paying about GBP 500 million, but it's quite a bit earlier. So is the key differentiation that yours is DPI versus nebulizer or were other areas where it's differential and you're only paying about 5% what Merck did? So is it just how far you are from the market. It looks like a very good deal, but it depends how differentiated it is.

Well, we definitely agree it's a very good deal. And yes, the market deals is not how much you spend, it's the kind of returns you can get. And we do believe we have a potentially best-in-class asset here in a field we know a lot about and adding to that COPD portfolio. I mean, I think there are about 7 questions in that. But in your first point on Blenrep, and just for everybody, as Tony said, we know you've got a lot of questions about that, but we hope everybody on the call understands how much we are committed to respecting the confidentiality of this process. We are in constructive dialogue. We have high confidence in our data. We're answering questions and adding more to that, and we'll update you when we can. And just to reiterate, we don't subsegment our peak year sales by country, obviously. The U.S. is important, but we're really pleased to have added -- by the way, since the ODAC, the across the board Europe approval, the Canada approval, to the U.K., to Japan. And you can rest assured that Luke is ramping up for launch preparations, of course, going slow to go big. And Blenrep is without doubt, an important medicine. We are working towards the U.S. approval. We want to bring this for American patients. When you think of this overall survival data in a head-to-head study, against the standard of care, when you think that 70% of myeloma patients are in communities, and this is a medicine that it allows people to be treated in communities. So we'll keep the conversation going there. I'll see whether Tony wants to add anything at all. He's shaking his head. Anything you want to say?

Just simply, again, to emphasize that obviously, we're in constructive dialogue, but we want to respect the confidentiality of that interaction. I'll update you as soon as I can.

Great. Thanks. And just because we want to get through as many questions as possible, I would respectfully suggest that we're not going to go much further than that on Blenrep today.

Do you want do the 3/4?

Sorry, the 3/4, yes. Tony or maybe Luke could be good because I know...

Yes, do you want to cover why you like the profile or if you can...

Yes, I'll start with why I like the collaboration for stock as the GBP 500 million is also dedicated course options to the other 11 innovative potential medicines that we have covering RI&I and oncology. Let me just describe the profile of the molecule itself. I would describe it in terms of its PDE3/4 balance as being similar to Verona. That's important because it means that we can be confident in the efficacy and safety profile of the molecule. Whilst it's similar in balance, it's about twofold more potent across that and has demonstrated both clinically and preclinically, both bronchodilation and anti-inflammatory effects. That reduction in dose is important when one considers the optionality for DPI. And as Emma said, we have an extensive experience there based on our own DPI portfolio. And I'm looking forward to developing that molecule and partnership. And we see potential really across the gold framework as an add-on therapy. Luke, do you want to add a bit more to that?

Yes. I mean, we've obviously looked at this class for a while for a couple of years now. We like it. I think the initial uptake is pretty clear. I think about 50% of the use is in very severe patients on top of standard of care, triple, et cetera. But I think there will be a threshold, where nebulization and the price starts to retard, let our hypothesis anyway, starts to retard things. So an alternative classical delivery approach, which is very synergistic with the rest of the portfolio is exciting. And then the final thing I'd say is it's a good sign for COPD and -- Nucala and COPD because clearly, there's an appetite for new mechanisms in particularly the more severe COPD population.

Yes. I mean -- and we're really pleased with the agility, frankly, aggression we've been showing on partnering for BD, as of assets out of China, whether it's the ADC deal we did or the long-acting TSLP or now adding this. And of course, some great science. We all know what's happening in the biotech industry there, but then we can pick up partnering and then rolling through Internet or global ex- China clinical network and of course, manufacturing, if that's successful.

The next question comes from Michael Leuchten from Jefferies.

Two please, 1 for Julie and 1 for Luke. Julie, your talk to the supply chain costs hitting COGS in the second quarter, and then your slides say you expect the gross margin to benefit from product mix, but it doesn't say the gross margin is going to go up. Can you just clarify what those costs might mean for the second half? Are they relevant or not? And a question for Luke. Nucala COPD, you've got GBP 500 million peak sales on the slide now. I thought in the past, you talked to GBP 500 million to GBP 1 billion, I might be wrong, but have your expectations come down for that relative to previous communication?

Definitely not, I'll say before Luke answers your question. And Julie, do you want to talk about gross margin, recognizing remember that we have included in our guidance, not only those enacted, but those indicated in terms of tariffs. So as that settles out with a bit more details to come, we'll have more specificity. But Julie, do you want to pick up on gross margin, and then Luke?

Yes, sure. Thank you very much for the question. So in terms of gross margin, we do anticipate some accretion this year. As you know, we took a charge for supply chain efficiencies in Q4 of last year of GBP 150 million. So we will be comping that coming up with the fourth quarter. But nevertheless, the big point is that the Specialty growth, which is very considerable, is driving an improvement in our gross margin. If all else was equal, you would see that coming through. What you see is causing some turbulence in the gross margin is, one, supply chain optimization charges are going through. And then the second one, as Emma just alluded to, is tariffs. Obviously, we haven't had any tariffs in the first half. We are anticipating some coming in the second half, and that will lower the gross margin slightly. But even with the ones that have either been announced or indicated, we still see the opportunity for gross margin accretion coming through mix. Luke?

Yes. Thanks, Michael. Look, I think GBP 500 million is fair. But of course, we are going to add above that. If I look at initial signs, we're already ahead of where Dupixent was at the same point in its launch with new patient starts. So that's a good sign. We don't -- I mean, the lead indicators are positive. So physicians clearly like the reduction in hospitalization and ED department visits, and that certainly resonates with them. We're also interestingly winning in terms of the perception in the lower EOS patient as well, which is naturally historically Dupi's hunting ground, which is encouraging. And if you look at the market research we've got, again, early days, but 67% of pulmonologists say they're likely to prescribe Nucala COPD, and prefer it versus only 30% with Dupixent, and really good execution so far. We've seen 91% of our key customers with a really good frequency. So bang on there. I think balancing that back to your question is pulmonologists historically have not been as aggressive as maybe the evidence would support in terms of biologic penetration. So once we get more robust numbers, which will be IQVIA, the [indiscernible] the lag indicators, we'll have a better picture, but I think it's a good start, and we'll give you a full update at Q3 when we've got data, which, of course, is what counts [indiscernible].

And the only other thing I'd say on this one is what we're aiming to do is be indisputable leaders in COPD medicines. That is the strategy that Tony has laid out with a comprehensive portfolio that we've added to, to be able to subsegment and treat this enormous burden of disease. More than 300 million people, third leading cause of death. 70%, as Luke said, of the costs related to COPD are hospitalization. Nucala is the only medicine that demonstrated 35% reduction in hospitalization. Tony confirmed the start of the depe COPD trial. So one of the things that might contain over time, the PTS sales of Nucala is bringing a 6-monthly IL-5 to COPD. And then, of course, we've got the long -- we've got the whole portfolio of assets that we've already started talking about. So exciting start. I think we've confirmed and reiterated GBP 0.5 billion for this one, but let's see how it goes.

Next question comes from Sachin Jain from Bank of America.

I got 2 or 3 product ones, please. So firstly, on the same vein on depe. Luke, I wonder if you could just give us a better sense of launch. How you think about market expansion, Nucala cannibalization switches from competition. And I guess specifically, consensus is only GBP 200 million for next year, which seems conservative relative to the launch you potentially described. Secondly, on Shingrix, I wonder if you could talk about continuation of the ex U.S. trends and how much of those European launches potentially boluses versus continuing? And thirdly, I will apologize, but I will try my arm once on Blenrep. Just want to understand why the data you've submitted, you wouldn't have used as part of the AdComm debate if it was material enough to shift the debate you knew was coming.

Sorry, I didn't -- it wasn't on purpose, but I didn't actually hear the third question on Blenrep. Could you repeat it?

Why data that you've submitted, you wouldn't have used as part of the AdComm debate if it's material enough to shift the FDA's view on a debate that you knew was coming and you get the briefing documents well ahead of the actual AdComm?

Yes. We're not going to comment on that. So good try. But Luke, would you like to answer the first 2 questions on ambitions around depe and Shingrix curves.

And welcome back, Sachin. Yes. Look, I think on depe, a lot of excitement. I think for anyone that's attended an academic meeting with the data has been presented, I think there's a lot of enthusiasm here and I'll quote some numbers to the market research. Inside, of course, the track record of this team with Nucala and [indiscernible] is very good. There's a high excitement there. I think with physicians, there's also a high anticipation. We've got really robust data here in controlled studies. And I think most people can see that efficacy, but also have the imagination to understand in the real environment with less supervision that data hopefully should improve, and we've got a program to capture that. Look, I won't go into the strategy and positioning, but the testing response is really clear. When we've taken that profile and that strategy to pulmonologists and allergists, 94% of them are motivated to prescribe the product. 70% think it's more compelling than competitors. And 87% of patients I cited certainly prefer it if the HCP would recommend it. We've done other forms of market research. Again, 86% of HCPs think it will be standard of care and 82% would consider prescribing it. And that's before the launch, right? I mean, we don't have a field force out there. This is very organic. Look, the [indiscernible] is 27 right now in severe asthma, around 12% in nasal polyps. And I've quoted this before, but if you look at biologics at the end of 12 months, you've lost about 65% of those patients. So a combination of in-office administration, lower frequency of administration, a validated known target, excellent benefit risk profile, I think it's going to be very exciting. We've also shown historically with Trelegy that we can target the…

Next question comes from Kerry Holford from Berenberg.

Just maybe a broader U.S. question here. On -- any commentary you can give us more broadly on the discussions you've been having with the U.S. administration on tariffs, but also in the context of MFN. How have those discussions evolved? And how do you think the administration intends to balance those 2 items, introducing tariffs offset and balancing that with the proposed plans to lower drug prices in the U.S.? Any directional commentary you would be prepared to make at this point would be very helpful. And then secondly, also on this -- the focus here in the U.S. The Trump administration has indicated support for DTC cash pay options for U.S. patients. Clearly, this is being utilized with obesity today. Is the DTC route to market, a route you would consider in the U.S.? And if so, which drugs within your portfolio might best fit that approach?

Yes. Thanks. So look, first, in terms of tariff, as we said, we've included in our outlook, not only those that are enacted, but those indicated. But it is important to reiterate that we're waiting on the 232 investigation and the sort of specifics of that still need to become clearer. I think it would be fair to say that you always have to separate from headlines to the reality of what's delivered. And whilst on the one hand, we're now seeing numbers and indications that perhaps are not as high as in the first run of this. On the other hand, it is very, very real in terms of focused on U.S. manufacturing and sourcing. Now the really good news for GSK, as I said last quarter, is we are well positioned on this. Since I started in this job, we prioritized together as a leadership team in the U.S. We've taken the business from being less than 40% to being more than 50% of the company now. And in fact, our Specialty business, which is where the pipeline is focused and the innovations focus and the growth focus is 2/3 of that so far this year is in the U.S. So we're well positioned for that. We're well positioned on manufacturing. We broke ground on another new factory. Some of the supply chain optimizations Julie referred to is also setting up some -- certain shifts of some of our production. So we'll continue to be agile around it. But whilst we'd rather spend any incremental costs more on the pipeline. And as you know, we prioritize spending on R&D, and we're pleased to be increasing that ahead of top line again this year. We think we're positioned well to find solutions as this evolves. On MFN, still very…

Yes. Thanks, Kerry. I mean, I think the first thing is the price has to be lower than someone can get it through their own program or insurance program. And then secondly, I mean, there are some products like Blujepa that could be amenable to that. We're looking more broadly at products like Trelegy, and we've got an open mind. There's clearly an opportunity in certain subpatient segments. We've seen that, as you mentioned, with GLP-1s. But I think it's very much, as Emma said, a watching brief at this point, but we can move very quickly once things settle out, we know what the rules are.

Next question comes from Matthew Weston from UBS.

Hopefully, you can hear me. One quick comment and then 2 questions, if I can. The quick comment is just to actually say, Michael is right, the GSK Respiratory Investor Deep Dive event, Nucala COPD peak-year sales was GBP 500 million to GBP 1 billion. But anyway, we take your comments. Two product questions, if I can. Camlipixant. Tony, the CALM-1 program does seem to be rolling back in terms of time line now second half of '26. If we've got such unmet need in chronic cough, clear efficacy, what's holding patients and physicians back from signing up to the trial? Or are we wrong, we just had the timing too early? And then secondly, I am going to chance my arm, Blenrep. It's just on study design of the existing studies which are still ongoing. Have you decided to change any protocols, recruit more U.S. patients or optimize anything in light of what you heard at the AdComm.

So I'm not sure there is going to be much to add on Blenrep for the reasons we've said. But Tony, if you want to add anything at all, please go ahead, and then perhaps you can answer on -- currently, I will just say there is no change to our level of ambition on the Nucala COPD. But Tony, do you want to comment on that?

Just simply, in general, on recruitment and forward-looking oncology studies, where we have -- where we're enacting extensive plans to ensure that we have greater U.S. representation going forward. In the case of the studies we have conducted, they were not atypical with representation in myeloma studies, and we were careful to ensure that the outcomes and demographics we felt were consistent in European patients. But more importantly, going forward, we have an extensive focus on U.S. representation. Then just if you mind if I just run straight into camlipixant...

I think it's worth clarifying this...

Yes. And look -- so first of all, there is nothing proving difficult about the camlipixant studies. We -- you will remember earlier, I identified that in CALM-2, we've been given the opportunity to add a larger proportion of higher frequency coughers into the study. That is the group for which we feel the pharmacology is more likely to be representative. And in addition, you'll also recall that because of the difficulties that Merck encountered in the design, the recruitment and other features of the study, we are taking careful action to ensure that we have covered all of that, both in terms of prescreening and other features associated with, for example, the cough counter. As I said, CALM-2 is proceeding on track as we planned. We are recruiting into the study right now. It is a 6-month completion. When we are closer to full recruitment into that, I will know more about the precise date, but we are on track for middle of next year. And as I said to Simon, we will, as we typically do with our Phase III studies, where we have 2 studies ongoing, combine both results into the analysis before the submission. So there is nothing behind that in terms of any difficulties associated with the study other than the plan that we've already described, which is ensuring that what we see as being the unique profile that camlipixant pant offers both in terms of its efficacy. And I'll remind you in the SUIT study, we saw a 34% reduction in cough frequency relative to placebo and in terms of its selectivity profile, which in simple terms is about 10x better than Gefapixant and is therefore likely to result in fewer dropouts and will certainly not unblind the study.

Next question comes from Peter Verdult from BNP Paribas.

Peter Verdult, BNP. Just 2 quick ones for you, Tony, just following up from Matt's. I hear your comments about adequate U.S. trial representation in your key programs. But just a factual question. When we checked DREAMM-10 first-line study, there are no U.S. sites. Now I know we can't talk about Blenrep, I will respect that. But it's a factual question. Am I correct in that assumption that there are no U.S. sites currently for DREAMM-10? And then secondly, on the Hengrui deal, after PDE3/4, is there any other assets you can call out at this stage that might be entering the clinic in the next 12 to 18 months? Or do we need to be a little bit more patient?

Yes. Let me just quickly deal with DREAMM-10. You're right on clinicaltrials.gov. It doesn't show our activities to recruit U.S. patients at this current point in time. But as I said, we have extensive studies that we're enacting that will increase U.S. patient recruitment, not just for DREAMM-10, but more broadly across the portfolio, including the new ADCs. And then sorry, secondly, remind me of the second question.

Hengrui.

Hengrui. We -- in signing the deal, we contemplated the first 4 or 5 of potential options there is -- but I'm not going to disclose those in any more detail at this stage.

The key is they're all in areas that are core to -- the core therapy areas for expansion for us, and we'll keep you updated as we roll those through.

And some of them will then be there in the clinic next year.

Definitely.

Next question comes from Rajan Sharma from Goldman Sachs.

So just wanted to get an update on Blujepa's launch. So I think it was approved back in March, but it doesn't look like it's launched yet. So it would be helpful to just understand time lines there and then expectations in terms of the launch trajectory, given that you've, I think, previously guided to more than GBP 2 billion peak sales for that new anti-infective's portfolio. And then obviously, based on the commentary, it looks like R&D expenses will be higher than previous guidance. Could you just help us understand what the drivers are? It doesn't look like there's any kind of materially large new trials that are kicking off in the second half of the year and maybe a couple are rolling off? So that would be helpful there.

Yes. And Julie, maybe you'll do that -- we have 4 big ones, big pivotals kicking off second half. And then Luke, I think, will comment on Blujepa. We did say last quarter that because of formulary timing, we're going to be a bit later with that launch, and there is a full portfolio of anti-infectives, but one we're very ambitious for a long time since anyone brought any new antibiotics. But -- so Julie, first, and then Luke, please.

Yes. Thank you. So the main R&D areas we sat down as a team and looked at the areas we wanted to accelerate. And clearly, one of the main areas is the ADC portfolio. I think as Tony has covered, we've got a large number of solid tumor opportunities with B7H3, which we are looking into to accelerate considerably this year and into next year. And then as Emma mentioned, we've got 4 pivotals now going through, 3 of which are BD orientated and sourced, and one is our own. So those are the main areas. Tony, do you want to answer that?

No, that's complete. It's 4 new Phase III studies in the ADC portfolio expansion.

Luke?

Yes. Thanks, Rajan. So as Emma said, we're talking to payers right now. Things should be more visible in Q3 with a full launch push in Q1 next year. If you just look at patients, there's around 15 million episodes of uncomplicated UTIs in the U.S., of which 3 million are individuals that are resistant to multiple classes or allergic to 3 or more antibiotics. That's the targeting population that we've got there. We just wanted to do a little bit more work on the pricing. And also, we've had positive Phase III results with tebipenem, which I think is also very attractive initially in complicated UTI patients who typically are admitted for ceftriaxone treatment. So this is the option of keeping those patients off the pump, keep them at home with patient benefits as well as cost benefits in the U.S. health care system.

Yes. And another trial stop for efficacy there. So excited to see what comes on further.

The next question comes from Steve Scala from Cowen.

A few questions. First, I'm curious about trends of Shingrix in China through the distributor. Are things improving, getting worse or somewhat -- or somewhere in between? Yesterday, Merck implied that there were no signs of improvement for Gardasil and issues could extend to 2026. Is the same true for Shingrix? Secondly, can we have an update on the pneumococcal vaccine program? Will you initiate Phase III in the 30-valent vaccine in adults? When do you intend to do that? Secondly, have you addressed the manufacturing issues for the pediatric vaccine? And when does GSK expect data readout for the 24-valent in infants? And then lastly, apologies, Blenrep, does the recent FDA CBER leadership change alter the outlook in any way? The proximity of the news is quite curious.

So on the last one, there's no read across from that. And let's go to Luke, please, first on Shingrix in China, and then Tony an update on pneumococcal overall.

Thanks, Steve. Look, the answer is, look, it's still challenging for all the reasons we explained in quarter 3 of 2024. However, there are some small -- they're very small green shoots. So if you look at in-market sales CDC, so market sales to CDC from Zhifei and the movement from CDC to the points of vaccination, there is a trend upwards for the last -- yes, 3 months from memory. But it's off a very low base, so heavy caution there. The other thing is the CDC stock levels are declining, and they've been declining since about February of this year. So it's not enough for us to trigger a major shipment to Zhifei, but it is -- it's at least pointing in the right direction. The other point I'd make is, look, we've done a lot of work on the strategy on the way forward here. It's very clear and we've got good alignment with Zhifei, and it's a focus on the comorbid chronic disease subpopulation, who are clearly higher risk. We seem to get better traction there. The competition has pulled back, which has created a bit of room for us, and we've actually increased our share of voice to take advantage of that. All the other parameters like ATP perception, patient perception are pretty stable. So again, I won't say anything about '26, but I would say we remain confident of the mid- to longer-term opportunity in China, and we just need to stick at it. And finally, we're also doing some life cycle. Tony mentioned this before, in terms of a dementia experiment within China itself. So yes, we'll keep moving forward.

Great. And then just quickly on MAPS, Steve. As far as the 24-valent platforms are concerned, both in adults and infants, we've learned enough from those platforms to move now to strategically prioritize the 30-plus vaccine. We feel that the characteristics of the MAPS platform are better expressed there. And I'm sure you'll follow that the field in general is going in that direction and sort of more tailored approach is also encountering some issues associated with, with concerns with regards to the evolution of new serotypes like serotype 4. We are on track with regards to starting our first-in-human for a 30-plus vaccine study at the end of this year. So you should expect readouts on that really in the first half of 2026. I'd say when you consider the progress we're making with regards to the 30-plus format and the competitive environment, we remain very much on track and competitive with the 30-plus vaccine, but that, of course, will be towards the end of the decade.

Great. Thank you. I think we have 1 more question.

Yes. Time for 1 last short question. Justin Smith, please, from Bernstein. I think you should be able to speak, Justin. Okay. That's not working, then we can also close the call.

Okay. Well, listen, thanks very much, everyone, for joining. Delighted to be reporting another strong quarter and this consists -- delivery of the consistent step-up of GSK since the separation and most excitingly, the R&D progress we continue to deliver. We're pleased to update our guidance for the year to being at the top end of the range and continue to be highly confident together of our -- not only our short, but our medium and our long-term outlooks. Look forward to talking to you over the coming days. Thanks. Bye.