Emma Walmsley: Thanks. Well, I’ll come to Tony on both of those. But just a flag, please do join us on the 30th of — or at least Tony and Luke, I should say, on the 30th of November when they will update you on some — the very exciting scale assets we have in respiratory, obviously our homeland and our heartland, including [depe] (ph) and camlipixant as well. But Tony, you might want to comment a bit more on the trials that are ongoing and then also on the ADC, which is obviously completely in line with our [Onc] (ph) strategy.
Tony Wood: Sure. Thanks, Emma. Hi, Simon. Yeah, I’m pleased with the progress we’re making on SWIFT-1 and SWIFT-2. As you’ve spotted, we’ve seen a slight acceleration in that, that was associated actually with also an acceleration in the ANCHOR study for nasal polyps. What that means is that the safety database that we need to underpin the file is now complete. You should expect, though, that we’ll stay on schedule with regards to the analysis and publication of the data and I won’t be doing that until we get the results for the second SWIFT analysis, which still places us in the first half of next year. As far as the ADC deal is concerned, Simon, so, yes, as you quite rightly point out, in terms of linker payload, there are similarities to Dato-Dx and therefore we derive confidence from the improved profile that you see for ADCs carrying that linker payload.
Two important things, though, to stress in the context of this deal. One, the antigen B7-H4 is selectively expressed on gynecological cancers. That’s why we went after the mechanism in line with our strategy for focus on women’s cancers and heme. And lastly, in that area as well, there is ample evidence of use of topoisomerase inhibitors as standard of care for chemotherapy. That’s related in part probably to the fact that you see a lot of DNA instability in those cancers, and as I’m sure you’re aware, topoisomerases work on that mechanism.
Emma Walmsley: Thanks, Tony. Next question, please.
Nick Stone: So, next question is going to be from Andrew Baum at Citi. Andrew, over to you, please.
Emma Walmsley: Hey, Andrew.
Nick Stone: Andrew, you’re there?
Andrew Baum: Yeah, I’m sorry about that. Two questions, please. One for Luke and the other one for Tony. So, for Luke, could you talk to the impact of the removal of the Medicaid cap, the MP cap on your Gen Med business, particularly respiratory next year in terms of quantifying the impact on revenue and earnings. And then for Tony, or I guess Kim [ph], if she’s on. There was recently reported the ATHENA cohort with Cabotegravir+Rilpivirine. There was a number of cases of viral rebound resistance, particularly in patients with high BMI or weight gain. Should we expect any label change as a function of observations in that cohort? And it was limited number, but still it was notable and remarked upon. Thank you.
Emma Walmsley: Thanks, Andrew. We’ll come to Deborah actually on the HIV pipeline first and then Luke back to you on AMP cap.
Deborah Waterhouse: Thanks, Andrew. So the ATHENA is a cohort study. It was presented at EACS eight to ten days ago. Actually, the finding is exactly in line with our clinical studies. So, as you know, there are kind of three characterized things that give you a higher likelihood of failing with Cab+Rilpivirine. Weight is one, so high BMI is one. And then obviously A6, A1 sort of subtypes. And then lastly, if you’re resistant to Rilpivirine. So, we clearly guide that those patients if you have two of those risk factors, you’re more likely to fail. We guide that, and that’s exactly what we saw in the ATHENA study in terms of the characteristics of those that failed. And it was in proportion with what we saw in the clinical study, which is obviously less than 1%.
So, no surprises whatsoever. Exactly what you would expect. And it just makes it more important that we continue to communicate through our sort of multivariate analysis data for whom Cabenuva is right and who probably shouldn’t be taking the medicine. But it’s a tiny proportion of the overall patient base that will get benefit from this medicine.
Emma Walmsley: And nothing new. Luke?
Luke Miels: Sure. Thanks, Andrew. I mean, as I said at Q2 that the exposure is US$700 million. But of course, we’ve had notice. So, we’ve got authorized generics in place. We’ve done some withdrawals that we’ve announced. We’ve done WAC adjustment with Lamictal. The other products impacted, of course, are Advair and Flovent and Serevent. Look, I think the impact is going to be sizable. We’ve started to reflect that in RAR adjustments now, but we need to judge to see what level of returns ultimately come back. There’s also some variables in terms of the percentage of switch to authorized generics, but we do have competitive generics, for example, with Flovent, so they may pick up more volume, making it a bit hard to forecast.
So, long story short, I mean, we’ve been prepared for this. We’ve been working on it for a couple of years. I think we’re in the strongest position possible. But there is going to be a material impact on that US$700 million, and that’s why it’s reflected in the outlook for General Medicines next year.
Emma Walmsley: I mean, that’s the really important point, is it’s a ’24 hit, but it’s all included in our medium-term guidance of being broadly flat in this business, where we’ve obviously seen a nice uptick in performance, not least as Trelegy continues to power forward and lead the way. So, all factored in and planned for. Next question, please.
Nick Stone: So, next question is going to be from Richard Parkes at BNP Paribas. Richard, over to you, please.
Emma Walmsley: Hi, Richard.
Richard Parkes: Thanks, Nick. Yeah, just a couple of questions. Firstly, on Arexvy. Can you talk about the unmet need in terms of severe disease in the 50-year-old to 60-year-old patient population just so that we can get a sense of — and also kind of what you would expect in terms of ACIP recommendations, so we can get a sense of how that label update might impact the opportunity going into next year? And then, second question is on Jemperli. Just wondered if you could talk about your confidence in expanding the approval into the MMR proficient population. Obviously, I think there’s sort of two options there. One is the overall survival data from Part 1 of the study. So, maybe you could talk about consistency of that benefit across those subgroups?
And then, the PARP inhibitor arm of Part 2 of the trial, I noticed you don’t include [Zejula] (ph) when you talk about Part 2 as an opportunity. So, I just wondered about your confidence in the PARP inhibitor maintenance arm of that study as well. Thank you.
Emma Walmsley: Thanks. Well, we’ll come to Tony in a minute on oncology, but perhaps, Luke, you can talk about the 50-year-olds to 59-year-olds opportunity, which is another 40 million people, by the way, in the US alone. So…
Luke Miels: Yeah. I mean, I think there’s two advantages. One is just the 40 — access to the 40 million people. And again, that lines up nicely with the overall Shingrix cohort. So, there’s lots of synergies there we can achieve. And then, there’s the broader advantage when we’re contracting in the retail and non-retail settings, because we’ll be the only one there. Our expectation at this point is it’s going to be shared clinical decision making, but as we speculated before the launch and I think so far that’s holding up, that’s not been a barrier during this initial phase of adoption. If you look at that 50-year-old to 60-year-old-plus population, there’s a sizeable proportion of them that also have one or more comorbidities. So, it’s attractive, and certainly it resonates well with primary care doctors in terms of their support for the brand, which is around 71% in terms of their preference overall for Arexvy.
Emma Walmsley: Right.
