James Quigley: I’ve got a question on HIV. So could you give us an idea of the amount of stocking that you saw in the fourth quarter and which of the key products were impacted clearly for the full year, Tivicay and Triumeq seem to fare better in the U.S. than the next U.S. So with those 2 products as well, what are you sort of assuming for next year in the guidance? And then can you also give us a bit more color on the dynamics for Cabenuva and Apretude in terms of take-up, patient attitudes, physician attitudes and how that’s changing with greater experience and how you expect the growth curve to look for the 2 long-acting drugs next year?
Deborah Waterhouse: Brilliant. Okay. So let’s talk about stocking. So we entered last year with about 3 days of stock, which was low. Normally, we exit each year with about 7 days of stock. So we entered this year with 3 days of stock, 2022, with 3 days of stock. We exited with 13 days of stock. So as you can see, there’s been a material shift between where we started ’22 and where we exited. If we assume that we’re going to just have a normal 2023 and that there will be 7 days of stock in the channel at the end of the year, you can see that we’ve got 6 days to burn, and we believe that’s going to burn in the first half of the year. So that’s kind of the details on the stock evolution. In terms of Tivicay and Triumeq, I mean we’re seeing Tivicay and Triumeq at a relatively kind of steady evolution.
Triumeq is declining quite significantly as it’s cannibalized by Dovato but also competitors. Tivicay is pretty stable actually. It’s declining, but obviously, it’s the only second-generation integrase inhibitor that you can have as a stand-alone and not as part of a triple or a doublet. So we continue to see a strong and sustained business with Tivicay. Triumeq, we think that business will decline as better opportunities are now there for people living with HIV. In terms of Cabenuva, so we’ve seen really strong patient demand. We’re seeing excellent execution from our commercial teams, which is broadening the prescriber base and deepening the number of prescriptions each physician is writing. And we’re doing a lot of work in the environment to overcome some of the barriers that you see when you introduce an injectable into a new therapy area for the first time.
And we’re really happy about the progress we’re making. The level of access is significant. And as I’ve said before, the quality is also really, really positive as well. So I think Cabenuva is doing really well. Apretude was slower last year. As we said in the first year of any new medicine and particularly in injectable, it takes a while to secure access and get all the big accounts signed up, the specialty pharmacy signed up on the product. That is now in a very, very positive place, and we’ve got very strong ambitions for Apretude in 2023. And again, all the research we do in terms of physician and patient. We know that the demand is very strong for this product as it offers something very different to the other, and obviously, we’ve got superiority data.
So I hope you take away from that a lot of ambition and optimism for our long-acting injectable portfolio.
Emma Walmsley: I think also, as Deb referred to in our comments, I mean, the overall momentum on 2DRs across the board, I think, is up to like 40% between Dovato and with long-acting of the business. That’s why we’ve done what we said we’d do in the shift of the portfolio, and we completely expect to do, again — to do so again through long-acting, as Deb said, with the profile of the business by ’26, but also to continue to shift beyond that ahead of the patent challenge on dolutegravir. And that’s what’s so exciting about what’s coming through in the next generation pipeline, which we’ll give — Deborah and team will give you more insight on the 18 months ahead.
Operator: We have a question coming from Andrew Baum from Citi.
Andrew Baum: Staying with Cabenuva and given the profitability of this product even with the profit share, it’s obviously hugely important for GSK going forward. Could you just give us a little bit more information on the source of the switching to date? And by that, I mean, just in the U.S. market, how much from Medicare, how much from 340B, how much is there for inventory? I know it may not represent long-term what things look like and its dynamic, but I would be interested. And then second, in relation to the new generation of cabotegravir line extensions, including the subcu, we’re going to get data in ’24. How long will it take, do you believe, to secure approval, assuming that you do PK/PD bioequivalence trial starting in ’24? Should I be assuming ’26, ’27 by the time you hit the market?
Emma Walmsley: Thanks, Andrew. So straight back to Deb. Just as a reminder for everyone, part of our portfolio shift strategy, which is evidence is working when you see that shift from 46% of the portfolio up to 2/3 and our confidence by ’26 is getting to 3/4 towards vaccination — Vaccines, sorry, and Specialty Medicines is so that we’re continuing to drive leverage in the P&L and affording our ability to keep investing at the same time in R&D and in our launches, too. So as well as within HIV through the innovation as we talked to, but also on the broad GSK agenda, we’re seeing an important area of focus there for us. Deb?
Deborah Waterhouse: So just to quickly cover your points, Andrew. So in terms of the source of business, there’s 2 ways we look at this. So first of all, where are we getting the business from and I can confirm about 60% of our Cabenuva business from our competitors and about 40% from our own portfolio. Second point, which is around what segments of the market are we getting Cabenuva from. Actually, we’ve got really good coverage across all the payers and all the key accounts. So actually, there’s the split that we see for Cabenuva is broadly in line with the split of the overall market, which, as you know, is 40% kind of commercial payer in HIV and 60% government. So there’s no unique attribute to Cabenuva versus how the market normally plays out.
In terms of the pipeline, so there are 3 time lines that we’ve laid out in our business investor update. So we’ve talked about a self-administered treatment and a longer-acting prevention between ’25 and ’27. Then we’ve talked about a longer-acting treatment, so 3 months-plus after 2027 probably in the ’27, ’28 period. And then we’ve got, which we’re very excited about, our third-generation integrase inhibitor, which will either be teamed with our capsid or with our bNAb , and that is where you’ve got the potential for 6 months plus in terms of gap between administration. And that’s towards the end of the decade. So that’s kind of what we’ve set out in the update that we gave. And we’re still absolutely on track for that. Very excited about the future.
And just to reiterate our shorter-term goal, we are very confident in our ability to deliver that GBP 2 billion of revenue in 2026, which is 1/3 of our overall business in HIV at that point.
Operator: The next question is coming from Tim Anderson from Wolfe Research.
Timothy Anderson: I have a question on COVID flu co-formulated vaccine. So Pfizer yesterday suggested the launch of a combo product in 2025, talked about it as a compelling durable offering. Does Glaxo see an opportunity here for itself? And what’s the time line of launch for a similar product from Glaxo? And then if I can just sneak in one quick housekeeping question. Zejula, when do you expect mature overall survival data from the PRIMA trial in frontline ovarian?
Emma Walmsley: Right. Well, both of those to come to Tony. And just as I think what he did refer to in his remarks, obviously, we’re pleased to see the data that’s come through from our partners at CureVac, and the potential for doublets here is definitely interesting. And we’ll update more on our actual specific plans, I think, later in the year. But Tony, I’m sure you want to add to that as well as the Zejula question.
Tony Wood: Yes. Let me just build on the question about doublets. And I think I’d start with just giving you a sense of the exciting data that we’re generating with our partner, particularly CureVac, in the context of establishing the opportunity for a therapeutic window between immunogenicity and reactogenicity. And in a doublet vaccine, particularly with regards to flu, for example, you can think about this as the majority loading of that doublet vaccine coming from components that are addressing flu. We very much see the opportunity in the second half of the decade associated with the high-dose flu market, where an 8-valent vaccine covering both hemagglutinin and neuraminidase antigens is really the opportunity at hand. So let me just quickly address what we’re seeing in these early monovalent data that gives us the opportunity for excitement.
And that is in the flu vaccinations, you will have noted that in a comparator — a monovalent comparator, we see immunogenicity at the lowest dose, which is consistent or better than that comparator and seroconversion, which is also better than the comparator. In our COVID studies, which have a slightly different comparative basis, we see reactogenicity, which is at the low end in terms of distribution of grades and severity at the highest doses involved. What that is doing for us on the back of monovalent construct is creating an opportunity for a window and therapeutic index that I think makes a valent flu plus COVID doublet a practical possibility. We’re now accelerating studies from monovalency into multivalency in a Phase II study the aim of targeting a multivalent seasonal vaccine focused on 8-valent flu in the second half of the decade.
As far as PRIMA is concerned, look, obviously, this is an event-driven outcome study. So it’s something that’s going to — I’m reluctant to give data on. We’re not expecting OS data before 2024.
Operator: The next question is coming from Graham Parry from Bank of America.
