Great. Thank you for coming, everybody. I'm James Gordon, Barclays European Pharma and Biotech Analyst, and today I've got the pleasure of hosting a fireside with GSK. We're gonna hear from GSK Chief Strategy Officer and Chairman of ViiV, David Redfern. Thanks for joining us today, David. Thanks, James. Always great to be in Miami. Very nice to be here. We've got quite a lot to talk about 'cause David's got a pretty broad remit. Think we're gonna try and talk a bit about the strategy for the overall GSK group, but we're also gonna talk about business development, and then as Chair of ViiV, we can also have a chat on HIV as well. Maybe just to start off, though, you've got a new CEO, Luke Miels, although he's not entirely new 'cause he's been there a while. Any early feedback about changes under Luke? What are we seeing and what changes might we have? Yep. Well, we're two and a half months in. I mean, firstly, I think Luke will be much more expressive in the second half of the year. But that said, I wouldn't expect any kind of big strategic shifts in the direction of GSK. I think the therapy areas that we play in, respiratory, inflammation, and immunology. Oncology increasingly, a very fast-growing business in oncology, in both solid and hematological tumors, and pretty much everything infectious disease. Obviously, we have a big Vaccine business, as well as HIV and increasingly in things like hepatitis B. I, you know, that is clear. I think capital allocation, very clear. We're very clear on the dividend. Investing in the business. Business development. You know, Luke has been a big driver of that with Tony Wood and I over the last few years. That continues. You've seen us being pretty active on that this year. The guidance, you know, that we've given that Emma set out, he has reaffirmed. I think you should think of Luke as very much focused on doubling down on execution, driving growth, simplifying the business, and particularly over the last few weeks, really getting into the R&D pipeline, and particularly the sort of phase II assets. We can talk more about those things like B7-H3, B7-H4, TSLP program, FGF21 that we got from Hansoh Pharma. Really digging in with the teams on how we make things like dose escalation, dose optimization decisions in a bolder, quicker way, how we can recruit patients, set up the protocols, run the studies faster. There's a real focus on pipeline execution, particularly the mid to late stage assets that are really gonna drive the growth in the 2030s. Thanks. You mentioned M&A, and so you're also heavily involved in business development. Maybe first, what are the two deals you've done recently? 'Cause we've had two quite recent deals. Why did you go for those assets? What's the appeal? We have been busy, and it's very much, you know, part of the strategy to continue to invest, to build the pipeline, particularly through the 2030s. The two M&A deals, we've done more than that. We've also done some licensing deals with people like Frontier. But we bought and have now closed RAPT, which brings a medicine for food allergy, very similar to Xolair, which is doing incredibly well here in the United States, but with a much longer half-life and then potentially up to 12-week dosing and a simplified dosing regimen. I mean, food allergy, massive issue. 17 million people here in the U.S. Enormous burden on the healthcare cost in terms of hospitalizations and so forth. It obviously builds on our respiratory expertise. We have an allergy sales force, and we think the RAPT asset is an improved version of Xolair because of the longer half-life and the simpler dosing regimen. Also, potentially, we can access the 25% of patients that either through weight or IgE level Xolair can't. We're excited about that. That's pretty symptomatic of the type of deals that we're trying to do, which is some level of scientific de-risking, so either precedented target or precedented mechanism, but with the potential to be best in class through some differentiation. In therapy areas where we have a very clear capability and right to win or very close adjacencies to those. The second deal we announced, I think only last week, 35 Pharma, a Montreal-based biotech company that has a drug for pulmonary hypertension. Again, builds on our respiratory expertise. We've had drugs previously, Volibris and Flolan, in that area. Again, precedented mechanism. This is an activin pathway inhibitor, but potentially spares something called BMP9 and BMP10, which is involved in increased bleeding risk. Think of this as sotatercept-like, the Merck asset, but potentially with less bleeding. It's very early, I have to say, so there is a bit more clinical risk around this. It's only in phase I. Potentially a very big medicine in that indication. I think of GSK as having quite a focus on infectious disease and oncology, which these two aren't in. Is it just chance that these aren't infectious disease and oncology, or is it quite deliberate you want it to be broader? Well, it's not chance. I mean, infectious disease, definitely we're very strong in, but we're extremely strong in respiratory, and we're building out adjacencies in things like inflammation with the Boston Pharma deal. We've got a lot of science around fibrosis, developed with lung fibrosis, so it's natural to move that into the huge indications of liver fibrosis. This is not chance. We're very thoughtful of where we go. We will do deals in oncology as well. In terms of the scale of deals you do, I'd say these are sort of moderate-sized deals rather than massive deals. Is that also quite a deliberate thing that rather than want to do one big bet, you want to have quite a broad portfolio of assets? Yeah, I think so. I mean, we'd never rule out doing a bigger deal if the returns and the stars aligned on it. I think we've been pretty active doing, you know, a series of these sorts of deals. What we're really trying to do is drive meaningful growth through the 2030s. I mean, that's what is behind all of this. I think the pipeline is building out extremely well to be able to do that. Would you consider doing deals for assets that were launched this decade? Or you think that the outlook is so strong for this decade such that it's only really post-2030s you want to be having a boost? We wouldn't rule it out. I mean, we clearly bought Sierra a few years ago now, which gave us momelotinib (Ojjaara) in myelofibrosis, and particularly, myelofibrosis patients with anemia, which is a significant proportion of them. That was a very late-stage asset. It's doing incredibly well. But I, you know, there aren't that many unencumbered really late-stage assets, and they're extremely expensive. I think we're in a pretty good space doing what we're doing. Makes sense. If we could, switch to talking about new product launches 'cause t here's a few things going on there. Actually, one of them is, I hosted a panel yesterday, which was about respiratory- Right. ...which got a lot of interest. Okay. We were talking about longer-acting therapies in respiratory. You've got Exdensur, a longer-acting IL-5, a six-monthly. How should we think about that fitting versus the other drugs that are already out there that are biologics that are shorter acting? Yeah. I mean, we're super excited about Exdensur. Every six-month dosing, I think that is very significant compared to the shorter-acting IL-5s, which are four to six weeks. The thing about severe asthma is it's very under-penetrated with biologic agents. Only about 27% of asthma patients take a biologic agent. So there's a real opportunity for increased biologic penetration market development here. I think all the feedback we're getting, and as I say, it's early days, but the qualitative feedback from physicians, the mood at ERS, six-monthly dosing will be, you know, extremely helpful in increasing that penetration. We will, of course, get some switches. I mean, there will be patients that will naturally want to switch from every month to every six months, obviously a lot more convenient. We're really focused on driving Exdensur into that bio-naive population. Early days, but, everything's on track. I think there was a study that came out that showed it wasn't quite non-inferior as an alternative to Nucala. Does that impact how you plan to do the launch? We're pretty relaxed. I mean, that was the NIMBLE study. It wasn't statistically powered to show that, the switch indication is in the label. All of that was disclosed to the FDA. We don't anticipate that will impact the launch. It reinforced actually the safety data of the product. We're pretty relaxed about that. Is this a category where it can take some time to get insurance coverage, and that's a bit of a headache? There's nothing particularly unusual about it. I mean, it always takes a quarter or two to go through the discussions with the insurance companies, but we expect this very much to be in the ordinary course. You know, I think the payer proposition for it, given the burden of severe asthma exacerbations often lead to hospitalizations and so forth. We don't anticipate anything being particularly difficult or unusual. It always takes a quarter or two. The other thing I'd say about Exdensur is it's Part B. There's about 25% of severe asthma patients that are Medicare patients here in the United States. That's very different actually from COPD, where Medicare is the majority of the patients. We are also in the process to get the J-code, which will take a few months. You know, everything on track, all in the ordinary course, and I think we're very excited about the potential. Of course, we're talking about severe asthma. We've started the studies now in COPD as well. Maybe just on that. We also talked about COPD yesterday. You've got an IL, the only IL-5 approved for COPD. How's that launch going? It's going extremely well. I mean, we showed some data at Q4. There's been a big spike up in Nucala NBRx. I think there's also probably a halo effect from COPD indication across asthma and nasal polyps. Yeah, Nucala's doing very well. I think the metric that is really resonating is a 35% reduction in exacerbations leading to hospitalizations. That's what you're really trying to do 'cause it's a progressive disease. It's incredible the burden of COPD. If you go into any emergency hospital, how many patients have COPD, you know, and are taking up resource. 10% of patients that are admitted never come out of hospital, and 50% die within five years. There's a real unmet medical need to come up with new agents there. Well, actually, just on that point of new agents, so there's some other mechanisms as well. We've got Dupixent, an IL-13 that's approved for COPD. We're also soon going to get some data for an IL-33. I believe TSLPs are also in development. I think you've got quite a few, including some longer-acting versions, going after all those targets. When could you broaden what you're doing in COPD and how do we segment it between those? We have Nucala today. We're running trials in different levels of severity of COPD patients now, just getting underway. EDGERANT and VIGILANT trials with Exdensur to six-monthly. We also have potentially the six-monthly TSLP. We will definitely take that into COPD. We still remain pretty excited around the science of IL-33. We have an IL-33 that we are progressing, and there is obviously the potential to create combinations of those over time. We're doing a lot of work on patient stratification. A lot of AI actually has been very helpful in redefining 'cause COPD was always thought of as just sort of one disease caused by smoking. But actually, you can stratify it in many different ways. Eosinophil level is clearly one. I mean, very simply, the IL-5s are most suitable for eosinophils over 300, maybe TSLP above 150 and IL-33 across all levels. I think we will get a lot more sophisticated as we move these clinical development programs forward in really identifying different categories of COPD patients that these can work for. Thank you. What if we shift to your other launch, which is Blenrep? Yeah. I don't know how accurate the IQVIA data is, but that looked like a pretty strong ramp initially in Q4. They may be a little bit softer at the beginning of the year, but is that data very reliable? How is the launch actually going? Again, it's very early days, but we're very pleased with everything we've seen so far. You can't totally rely on IQVIA, although it is showing very strong growth. It's obviously Part B as well, so IQVIA is incomplete. I mean, two things are very important with Blenrep. Firstly, it's an incredibly efficacious medicine. We saw that from the DREAMM-7 results, progression-free survival almost three times the standard of care, daratumumab, and a 50% reduction in the risk of death. It's very meaningful. That efficacy is absolutely resonating with the hematology community. I think there is a real enthusiasm for a BCMA agent post the first line or post CD38. The other thing about Blenrep is the very simple infusion. It takes about 25 minutes to half an hour. It can be given on an outpatient basis. It's incredibly well-suited for the community. Here in the U.S., 70% of patients and hematologists are in the community. We're excited about that. It's obviously third line initially in the U.S., second line in the rest of the world. We're just rolling out, you know, ex-U.S. The U.K. was the first market. No hard data points at this point, but everything very much on track. Is there a lot of work to do in terms of training both the doctors and also ophthalmologists? I think at one point, GSK had talked about going slow to go fast. Do you need to go quite slow before you go fast, or have you gone quite a lot fast? Yeah. I mean, I think what we mean by that is we're very keen that the early patient experience with both the patient and the hematologist is positive. You know, we're encouraging the hemes to be very thoughtful around which patients they put on it initially and then work very closely with them. On the REMS, it's much simpler than Blenrep 1.0. It does require an eye exam each dose in the United States. In the U.K., it's just the four doses. But that can be done routinely by a high street optician. It's a very simple slit test. They're very experienced in dealing with cancer patients. We've trained several thousand opticians across the U.S. The qualitative feedback we're getting from hematologists and the opticians is that process is all working pretty well. The paperwork associated with it is actually massively simplified. Great. Well, I definitely want to ask lots about HIV 'cause of your being Chairman role. Maybe I'll just ask one about the pipeline before switching to HIV. One of the interesting readouts I think this year is camlipixant. There's two elements. Generally, how excited are you about these readouts for chronic cough? And then the other question was could there be differences between the two trials? 'Cause I think I've heard a comment from GSK that the second trial might have people that cough even more, like the more acute patients or more severe patients. How do you think about the two different trials and the overall excitement for the program? I mean, look, refractory chronic cough is a serious condition. We know that there's about 1.8 million people in America being under the care of a pulmonologist. Their pathway there is often quite different. 50% of them have probably seen three other different types of doctors, allergists, GPs, and so forth on the route. There's really nothing today that really treats it. They're taking a mixture of OTC cough medicine, sometimes pain medication, opiates, and so forth. We're very clear on the unmet medical need. The studies, CALM-1 and CALM-2 will read out in a pooled analysis, in the middle of the year. All of that is on track. You're right. CALM-2 has got slightly more patients in and more frequent coughers. You know, there may be a slight difference. I think I'm right in although it's a pooled analysis, effectively both trials have to statistically hit to ensure that the overall trial hits. You know, we'll see in the middle of the year. I mean, I would remind you that the phase II data showed a 34% reduction in cough frequency. The phase III is a 12-week endpoint. We probably expect it to be a bit lower. You know, the 15%-20% mark will probably be about par because it's a bigger trial. We probably expect a bit more placebo effect, but we shall see. We're not too far away now, so we'll probably have a discussion post these results. That sounds good. In that case, I'd definitely like to switch to HIV. To start with, there was the CROI conference recently. Where you presented quite a few data points, and in particular, I was interested in the data you had for four monthly, but even more so what you might be able to do for six monthly. Maybe just briefly, what did you present there? Then what does that say about what your longer-term plans might now look like? Yeah. Actually, James, at CROI, we didn't present much on four-monthly, but for both PrEP and treatment, four-monthly very much on track. The PrEP will read out this year and hopefully launch next year. Treatment is about a year later than that, and we will start the pivotal bridging study later this year. What we really presented at CROI, and what we're very excited about is our six-monthly treatment options. And we presented PK data on our third-generation integrase VH184, which we'd already shown has a very broad resistance profile against a much broader set of mutations than cabotegravir or dolutegravir, which has been very well-received by the community and by the KOLs. We showed PK data on that that showed that we're very confident of going to a six-month formulation. Similarly, GSK3640499, our capsid inhibitor, which is very similar actually to lenacapavir but with less drug-drug interactions. We showed PK data on that, which is very affirming to a six-month formulation. The next stage now is to test six monthly formulations of those in infected individuals. I think then the third piece of data that we showed from R&D was our neutralizing antibody, N6LS. We showed four-month data on that, but we've got data coming in six months. Again, that was very effective. We've got some options of how we build a six-month pipeline here. I think we've got growing confidence that we're gonna potentially have a best-in-class six monthly treatment. There's you know, there's more work, clinical work to do. We will do a meet the management event at some point in the middle of this year and go into a lot more detail around this. Why would you pursue one of the six-monthly options versus the other? My understanding is that a broadly neutralizing antibody, it wouldn't work for absolutely all strains of HIV, and you still need to get the six-month data, but you've got some four-month data that looks encouraging. The capsid, you've already got six months data, and it could work for everyone. Why not already just go forward with the capsid assumption? Yeah. That's a very good question. It's a question that we are still thinking through. There's no doubt, you know, the capsid is gonna be broader, and I think 184 plus 499 has the potential to be, you know, a very significant medicine. With the antibody, there's actually been quite a lot of science over the last year or so around the impact of antibodies on the latent reservoir in HIV, even in patients that are virally suppressed. There's work going on to look to see whether there are particular patient groups that might be important for. I think, and I know Andy Dickinson was here before with Gilead, it's all about having options. You know, it's a bit like we had Juluca and Dovato. There are a diverse group of patients and having different combinations that could be important for different groups. I mean, to that point, it's a big opportunity, and they both sound interesting. Could you just take them both forward? We could, yeah. Watch this space, and we'll update you later in the year. Actually, so we had Gilead on first, and there's been some talk about less frequent orals. I don't believe you've announced a less frequent oral program, but you've got a third-generation integrase that looked very effective. Is it the sort of drug that could be made into a less frequent oral? The PK on 184 is such that that's probably not the optimal medicine to be in a more frequent oral, but we are certainly looking at possibilities in that. I think, you know, our main focus is very much six monthly, but we are open-minded on other things. What about the route of administration? Does that matter? 'Cause some people have noted your products at the moment are intramuscular. Some competitors are going for sub-Q. If you're talking about something where you only gotta get it twice a year anyway, how important is whether it's IM, IV, sub-Q? I think it's very important in PrEP. We haven't got on to PrEP. You know, there's no doubt that years to go, you know, even though it's doing well, there are quite a lot of nodule issues from the sub-Q formulation. I think in treatment, our aim is very much to develop an IM formulation. You know, we'll have to see. I think that's definitely possible for four nine nine. We've got a bit more work to do with one eight four. But there is less pain, there's less nodules associated with IM in our view and all the research we've done. But I would say, I mean, the thing that's underestimated a little bit, the chemistry around these long-acting formulations. Integrase chemistry itself is very complicated. I think part of the secret sauce of ViiV has been its integrase chemistry, both inside ViiV but also with our great partner with Shionogi. I think we've got real competitive advantage there. If Gilead is able to bring along a once-a-week PrEP as a pill next year, do you think that would be a big challenge to Apretude as a two-month or a four-month injection? I think in the PrEP market—I mean, we, I agree with Gilead. I mean, the PrEP market is growing strongly, and having a second entrant in long-acting is absolutely helping that. I think having different options is always good. At this point, Apretude is continuing to grow very strongly along the lines of the last couple of quarters. I think if you, if there is a once weekly, I'm not sure that's necessarily coming next year. I mean, it will cannibalize the daily orals, for sure. But, you know, we're focused on long-acting. Great. Well, I'm looking forward to this, HIV event and hearing more. With that, I can see we're out of time. Thanks a lot for joining us today. Thanks, James. Thanks, everyone for coming.