I think we're, we're rolling judging by the clock here. So-
Okay.
Thank you, Richard, for joining us here at the BofA Global Healthcare Conference in London. My name is Jason Gerberry. I'm one of the mid-cap biotech and specialty pharma analysts, and so pleased to be introducing our next company presenter, Teva Pharmaceuticals, and Richard Francis, CEO. Richard, it's been what, about eighteen months on the job, and a lot has changed, I think, for the better. You know, I think your predecessor was focused on dealing with some legacy issues with the company in terms of leverage and some litigation matters, and then you've been able to come in and now start to orient the company towards more of a growth driven strategy.
So I don't know if you wanna maybe just level set for the group here, just to kind of, you know, what you've observed at Teva, some of the good, the bad, and kind of where you see the company going.
Thanks. Firstly, thanks, Jason, for having me. Always good to see you. Good to see you in London. So yeah, actually, it's been twenty months, not that I'm counting-
Yeah
since I came in, but what we've done in that twenty months as a team is developed a clear strategy, pivot to growth, and you'll hear me and, you know, we talk a lot. I talk about it all the time, is the strategy sets the direction of the company. We're growing this company 'cause we have a strategy to grow it, and it's based on really maximizing our innovative portfolio in the market and in our pipeline, as well as making sure we have a growing generics business. I think we have the capability to do both of those really well, and we have to be disciplined and focused.
But what we've shown, I think, to the surprise of some, is that from an innovative point of view, we've accelerated our products in the market, Austedo, Uzedi, Ajovy, and Eric Hughes, the head of R&D, has brought our pipeline through really quickly. So I think we're redefining Teva a bit. You know, we are not a global generics company. We're a global pharmaceutical company that has a world-class generics business and has a world-class, emerging, and very fast-growing innovative business, and we've done that. I think that's why it's galvanized the company, and you said, you know, what's the good, the bad? The good is it's a great company with great people who really want this company to be successful. So the commitment to the strategy, which is always important, has been 100%.
And so we've done a huge amount in a short space of time 'cause people are clear about what they have to do, and they want to do it. And I think that's where we are, and I think, you know, this is just the beginning.
Okay, great. So you've talked a lot about your commitment of Teva becoming investment grade and maybe why that's so important. What's a realistic timeline that you think that the company could get to being investment grade? And then, I guess as we think about some of the puts and takes to getting to that, be it either you've got some divestitures that could accelerate things, you've got maybe a few legacy litigation matters that maybe some puts and takes there. So maybe, do you see those as kind of generally offsetting factors and maybe just kind of frame that dynamic?
Yeah. So look, I think firstly, we have our guidance financially for 2027, which is a 5% CAGR revenue growth, OP of 30%, and net debt to EBITDA ratio of 2x, and a cash conversion of 80%. Now, those are goals we set. Now, people ask me about those goals, and we are sticking to them, and we're gonna do them. And as we've got more favorable in our performance and our outlook, people have said, "You know, do you really need to do investment grade? Do you... You know, why are you targeting that?" And I've said, "'Cause we said we were, and Teva will do everything we say we're gonna do." And so we said, we're gonna do it, and we will do it.
Now, to your question of how quickly, regardless of divestments, regardless of anything, we're on a clear path to do that by 2027, if not even before. Obviously, with some divestitures, our capital allocation is pay down debt, invest in our growth drivers, and do business development. So if obviously some of these divestitures happen, it gives us the optionality to accelerate that timeline.
Yeah.
And obviously today, we were talking about earlier with the rerating by Fitch, who moved us up one notch. What was pleasing about that is obviously that's, I think, a validation of the strategy, the work we've done, the execution we've done on that, and their belief that will continue, and hence the reason they give us that positive outlook. So I think for me, getting the debt down is important because we said we were, and obviously that gives us a lot more optionality as to what we can do going forward once we've had that in place.
Yeah. Okay. And mindful that business development has taken a backseat to some of the other capital allocation priorities as you look ahead for the next few years, is it still maybe smaller structured transactions, kind of light on the upfronts, maybe more back-ended bio dollars, as sort of the opportunities that you can kind of pursue around the edges here, in the near term? 'Cause it sounds like, you know, operating towards this 2027 goal and these longer-term targets as a priority set would seem like, you know, larger deals are still kind of on the sideline.
I always think about capital allocation, regardless, is where do you get your best return? If you think about the 2027 goals, we can do and we can achieve the 2027 goals and beyond a lot organically. You know, our pipeline, whether you... we'll probably talk about olanzapine, TL1A, ICS-SABA, IL-15. These will all bring growth in 2027 and beyond, and some actually sooner. The need to do BD is less sort of critical, and we've always got to think when we allocate capital, if we allocate to the BD, are we funding those internal opportunities well? I think that gives us optionality.
Now, that said, to create a company that's going to be growing successfully for 10, 15, 20 years, we need to make sure that innovative pipeline is filled properly, and also our commercial infrastructure, we leverage as much as we can. So we have. You know, we can have more things in the bag, we can have more things in our pipeline, but the barrier to us allocating capital is quite high because we want to make sure it will drive our pivot to growth because we know we're on a good trajectory, so we don't really need to. We don't want to destabilize that. So that's how we think about it. Now, I look at a lot of stuff all the time, but I always compare it to the things we have, and so that's the criteria we look at.
Okay. Well, maybe shifting to your LAI. I oftentimes think about your LAIs as more of a portfolio of two products, right? And you have Uzedi that's marketed. Now you have olanzapine, which is largely clinically de-risked. I think we're getting detailed data at ECNP for this program, and you've guided to something like 10%-20% of the market could be the peak revenue potential of these two together, so call it $100 million-ish or so, right? So maybe is that sort of a conservative placeholder as you think about the Uzedi launch, how that's gone, and just how the payer environment looks for newer, innovative LAIs?
What's sort of the landscape that you're launching into and maybe some of the puts and takes, 'cause Olanzapine clearly has a big volume opportunity, and I think people see that as one that is a little tricky to forecast, and maybe you hold off on getting too bullish until you see a label.
I think that's good advice.
Yeah.
But to help answer the question, though, look, I'm really excited about what we've done with Uzedi. I think Uzedi has raised the eyebrows in the market as to, "Wow, you seem to be doing really well with this product," 'cause we have a good product profile. But I think what that's helped us do is really understand the psychiatric community, the schizophrenia marketplace, and shows that if we have a differentiated product, we can do well, despite what you've highlighted is the challenging payer environment. In a challenging payer environment, you have to bring value, and we're clearly doing that at Uzedi. As we bring olanzapine along, what I like about this, that will go into exactly the same infrastructure, be it our managed markets, be it our sales representatives, our MSLs, et cetera. So that completely leverages those.
We get synergy there, but also, we're bringing olanzapine along two years after we bought Uzedi. I think those relationships with the customers and the key stakeholders is going to help us, you know, have a really good launch of that product because the market does need a long-acting olanzapine, as you know. And so I'm excited about it. I think we're going to get clear on what we think that opportunity could be, as we get closer, 'cause we're doing a lot of research, and we do want that final label. And, you know, on that, the safety, we're now at 99% of injections completed, with no PDSS, so that's really positive.
But I sort of want to get to 100% and have that done, and then be clear about what the label is going to look like, and then I can really understand what the opportunity is. But it is significant, and it's significant for Teva, because one of the things about Teva is our innovative business is growing very fast, and I think it's very attractive. But the base of that business means if you add a product on that, that does $500, $800, or $1 billion, it really changes the dynamic of the growth on the top and the bottom line.
Yeah, so you mentioned the... Or I guess I mentioned the label. You've followed up with that. But thinking about Relprevv, that's the marketed version of olanzapine currently. When I talk to physicians, it's really not the black box, it's the three-hour post-dose-
Yeah
... monitoring that, that has sort of been the commercial killer-
Mm-hmm.
For Relprevv. So maybe just talk about sort of the regulatory interaction when you designed this study and the thirty-six hundred injections and sort of the discussion to ensure that maybe you don't have that monitoring requirement, 'cause that seems to be the key label variable.
Absolutely. Yeah, so look, we had discussions about guidance from the FDA, what would be required to show efficacy and safety, and we had those discussions about PDSS. And so we've designed a study in line with what they want, so you know, I'd like to think we're confident that we don't have PDSS-
Mm-hmm.
Then that changes the label. That said, I'm always warned by my regulatory colleagues, is the FDA has the freedom to do-
Whatever they want.
Whatever they want. But I think don't forget, a lot of the phase III clinical trial sites were in the U.S. and Europe, and so these physicians also will have, are excited 'cause they've been treating patients with this product. So I think all of that, I think, helps us lead to a positive outcome, but we'll have to wait and see.
Okay. So I think in the past, with Uzedi at least, you know, some of the regulatory issues, I think there was a CRL-
Yeah
... that sort of maybe delayed the launch relative to expectation, and there's some commentary that perhaps maybe the payer contracting maybe wasn't where you'd want it to be for year one. So what does that mean for year two? Like, you know, do you feel like, you know, year two, you'll be more on a fully contracted basis, and then there's an acceleration to uptake? And does olanzapine have a different contracting trajectory relative to, say, Uzedi, if everything goes to plan?
You know, I think you summarized it really well. Look, we did have a more challenging payer environment to deal with. That said, it's because we didn't want to discount. We understood the value of our product.
Yeah.
And people asked for a discount, and we said, "We don't understand the value of our product." So we held the line. And what we're seeing now is physicians are still pushing through the product because they see the value of the product, because you can get to a therapeutic level dose-
Yeah
... within one dose, right? Which is huge. And so I think the payers now are coming back and saying: "Okay, this clearly has a difference. Can we start discussing it?" But I think what that shows is the discipline we have at Teva is we know the value, and we're prepared to show the value and wait for that. Now, how does that lean into olanzapine is your question. Firstly, we know all the people now. We've been contracting with them for, it'll be two years. We know all the forming committees in the hospital. We know all the key stakeholders. They understand the technology behind Uzedi, which is the same technology behind olanzapine, and they see the huge need and the value it brings, so you don't have to hospitalize these patients who are having an episode.
So I think that puts us in a really good place, but we'll have to wait and see, because we're not going to discount this to a level we don't think reflects the value of the product, and that means, you know, we'll always have that in mind because we're not playing a one-year race.
Yeah.
We're playing a five- to ten-year, but I do think for Uzedi, to also answer another part of your question, we do see the product being able to perform better in 2025 because of that access.
So with olanzapine LAI, is there, you know, if you could maybe preview what we would learn incrementally at the ECNP medical meeting. I mean, we kind of have gotten top line on efficacy. We know 99%. I presume maybe we might be at 100% by ECNP, but anything you can kind of preview for that update for investors?
I think, you know, if we obviously do have the full safety, then I think that'll be announced. But I think that sort of we want to make sure we have the most current information ready for that presentation. So I think you'll have to sort of wait and see. So everybody's going to have to tune in.
But we will get, I mean, detailed tolerability data. I know that's one question about olanzapine and some of the legacy issues, even with the oral molecule around the metabolic profile, and I imagine investors will get the first look at a more detailed-
Yeah
... safety profile.
Yes, and what we've communicated is, you know, we're not anticipating that to be vastly different-
Than the oral.
And we get. If it does, that's a positive, but I think we're, we see maybe no, no reason to believe that. But let's see how the data actually stacks up. Obviously, the thing that's really front and center is the PDSS, and so I think that's what people are wanting to understand, you know, how many injections, how many patients, et cetera, and the detail behind that.
Okay, and certainly some investors, because of olanzapine's high volume, think that this could very easily be a billion-dollar drug, right, and Invega has had the ultimate success in this space. Do you think that this is a space that there is meaningful upside potential still for something that maybe can tap into? And this seems like an area of unmet need that hasn't been tapped into in the therapeutic space. I'm just curious to get your perspective there.
Yes, look, I mean, without commenting precisely on the number, I think the unmet medical need is huge. I mean, olanzapine is the most efficacious molecule that's used in schizophrenia. It has 20% of the market, and obviously, when you deal with the most efficacious, you're dealing with the patients who have the most difficult condition. And those you need to be compliant because the compliance is obviously important in schizophrenia, but it becomes even more important, the severity of the disease. And so when we speak to physicians, they say, "We really need a long-acting because I need to know the patients are controlled, and they're taking their medicine." So I think the unmet need is there.
The excitement, I think, is there, and this molecule is really valued by psychiatrists because of its efficacy, which is what you need. Frontline, you need efficacy. So I do think the opportunity is significant. The things we have to manage through is the managed care and how, you know, that is going to be managed and what that means, and making sure we still have the right value proposition, but this is all positive, you know, this is all sort of degrees, and for me, it's very exciting, and what's also exciting is we're becoming sort of known within this community with the Austedo, Uzedi, and now Olanzapine, as the sort of big player.
Yeah.
When you go to conferences, people say it is Teva, which is a turnaround from eighteen months ago, where you're a generics company dabbling in innovation, and now we're seen as an innovative company as well, where we're leading the way in psychiatry. And that shows the transformation you can have when you really focus the business, really focus the resources, and really build capability in your R&D and your commercial teams.
How much synergism is there with the LAI piece of the business and Austedo, which Austedo has, probably a meaningful proportion of scripts written by psychiatrists?
Yeah, there definitely is an overlap, and there's synergy there. Obviously, there's synergy from a managed market. There's synergies to a certain degree from a KOL. So we definitely do have that. So that's an advantage. We also are mindful we want to maximize the assets, so we're not trying to be, you know, incredibly focused on can we share costs? Because the opportunity for both brands-
Mm-hmm
... and Uzedi and Austedo is so significant. We want to make sure we allocate enough resources to maximize that, because I think that's the thing we didn't do well in the past. We really didn't invest in these, and now we've invested in building capability and allocating resources, and I think we're showing the return on that.
Okay. Maybe shifting gears to Austedo, which has been really arguably the big growth engine for the company. It's your highest margin product, and so I imagine as that continues to grow towards your 2027 kind of aspirational or whatever you want to call it, longer-term target, that should drive a meaningful amount of operating leverage, I would think-
Mm-hmm
... into the PNL. You have flagged maybe 2027, 2028 as a year where there could be a drug price negotiation impact from the IRA. I understand that that's a prudent base case to have, but there's also a generic of tetrabenazine in the market that has something like 10-15% molecule share, and there is an exception, if there's a bona fide generic, that you could be exempted from IRA. So, maybe it seems like, is it prudent to maybe be mindful there's a number of scenarios that could play out, including that there could be an exception to IRA?
So you're definitely glass half full, aren't you, on that one?
We don't know what bona fide-
Yeah
... generic means.
Exactly. There's a lot of things in the IRA we don't know, and the way I think about it, I'm a bit more glass half empty on most things.
Okay.
And then if there's an upside, we'll deal with it. I think we, as we've communicated, we always put in the impact of the IRA as best as we could calculate it back in 2023, when we gave the target of $2.5 billion. We know that number is wrong. The question is, how much? Is it too big or is it too small? And we'll see how this plays out. I think what we've always tried to do at Teva since I've been here is be measured in everything we predict and not expect us to always have the better outcome. And let's accept that we're probably not, and then we'll build our business, our resources, and our financial strength around that, and if it ends up being more positive, that's upside.
But yes, the IRA, I mean, I think it is very difficult to understand, as obviously somebody who's worked through NICE and the European regulation, which are very clear and methodical. This one's a hard one to interpret, so there could be some upside, but for us, we're playing it out as if it's going to happen sooner, so it's in 2027, not 2028.
Uh-huh.
We could be in twenty-eight. And we'll navigate all of those. The thing that I keep reminding people is by then, Uzedi will be at its, you know, a nice run rate. Olanzapine will be launched, and that'll be growing, and we'll potentially have ICS/SABA that's launching in its, you know, first eighteen months. So it's not all about Uzedi. We'll have three brands, and Ajovy keeps growing. So the impact that will have on our growth, whether it's, you know, more severe or less severe, is, I think, to a certain degree, mitigated already because of the effort we put in accelerating our pipeline.
Yeah.
That's how I was thinking, because I don't think about 27. 27 of those targets we committed to hit, we will hit, but I'm already thinking about, you know, how do we get to 30 and how do we keep growing this company?
Got it. And so when I looked at IRA, obviously, there are a lot of older drugs that were really heavily rebated already, and so the difference off of WAC were huge percentage-wise, right? But I know there are estimates that maybe it was more of a 15% cut off of net, right? So Austedo is arguably probably not a heavily rebated drug, given kind of where you play. I don't know if you would push back on that supposition, but is that kind of the right way to think about directionally, something in the 15%-20% that's phased in over three years, and then after that, you can kind of return to just growth on volume?
Look, I really don't want to speculate about it because I think you're right. Some of the big differences may be that you see on the slides and the headlines are not as substantive when you get into the difference between the net already. There are many factors that play into this. I think I don't want to get drawn on that. Let's see how it plays out. You know, what I would say, and you've touched upon it there at the end, is Austedo doesn't stop growing in 2027, regardless what happens. You know, that will maybe change the gradient for a period of time, but there are 785,000 people suffering from tardive dyskinesia, and I think we've got about 100,000 on treatment. So the opportunity is still significant.
It's a question of, you know, what happens to that growth profile for a period of time, and that's what I keep reminding people of. And in the context of Teva and Austedo still growing, and then the three products I've just mentioned, you know, from a forecasting point of view, that's a we just have to debate what the growth is going to be, not is-
Yeah.
there going to be growth? And I think that's a really different story than we've had in the past with Teva, and that's a nice conversation to have. And that's what I always ground people at. All right, we've taken into account. We're sort of facing up to that. It'll be what it'll be, but regardless, it's not going to change our ability to keep growing the company.
Okay. So on your longer-term target, I think it implies about 400 basis points of operating margin expansion.
Mm-hmm.
Conceptually, I'm just curious if you'd agree with this. I mean, you have a headwind in Revlimid, but then you have a bunch of biosimilars kicking in, and I kind of think about those two as kind of offsetting the partnership economics and, and then you overlay that with Austedo, and if you're able to kind of stack $1 billion of revenue on your highest margin product, is that really like the key to thinking framework-wise to how you get to such a profound operating margin expansion?
Yeah. So firstly, I mean, I think, profound is sort of the right word. I mean, 30%, if you're a pharma company, people don't hit that.
Yeah.
And we're a company with $8 billion of generics, so I think it's going to show a great tune for the company and a great management of the P&L and the cost structure to achieve that. But yes, I mean, we need to really maximize our innovative products because they have a high gross margin, and then we need to do exactly what you've said. I think we have the biosimilar opportunity to offset some of that Revlimid. But also, don't forget, we launched our GLP-1 this year. We have potentially octreotide coming, pitvastatin, we have Symbicort, we have many complex generics coming. The more we do that, you know, if you aggregate those together, those have an ability to offset it as well as have other growth. So I think we have already sort of targeted-
Mm-hmm.
2026, how do we think about that? And once again, it sort of goes back to that discussion, IRA, whether we keep growing in 2026 or that growth slows down a bit, whatever happens, the direction of travel for Teva, in my mind, is really clear.
Mm-hmm.
It's growth. Depends on if you pick a year or you pick a three-year or a five-year or a seven-year, it is clear growth. That's without starting to talk about what's going to happen to TL1A, what's going to happen to IL-15, and some of the things we have coming through, and the drug for MSA, which if it's efficacious, which I agree, it's a challenging disease, but that could come to the market a lot quicker. All those factors together, it feels like a very different value proposition than it was.
Yeah.
It's just the range of that, which I think is a different conversation.
Okay, last one on Austedo.
You can stay on Austedo for longer if you want.
It's obviously a really critical product, but the tardive dyskinesia market, I think, by our estimates, was maybe 20% penetrated-
Mm-hmm.
With the VMAT2 inhibitors as a class, thinking about your product and Ingrezza. And so some of the growth has been things that can improve revenue capture per patient, right?
Mm-hmm.
Titrating up to the highest dose, so just trying to disentangle the growth dynamics, how much of that is increasing penetration in patient volumes versus things that maybe improve that revenue capture per patient?
Yeah, I mean, that's. You hit the nail on the head there. I mean, people talk about how many patients we bring to the market, and we get them diagnosed. I think that's really important, but there's huge opportunity in making sure patients get on the right dose, have the right adherence, and then standard therapy for a long period of time.
Mm-hmm.
Which obviously with these patients, with their conditions, is difficult. And we just started that journey of putting programs around those to help that, and we're already seeing traction on that, but I think that's the other big value driver. It's not just bringing patients in, it's how do we make sure those patients are treated long-term on the right dose and compliantly? That creates a revenue upside as well. And, you know, the team we brought in to focus on this have really put in some great programs, which, by the way, are only some of them starting to get some traction now. So those will keep improving quarter on quarter and even year on year.
So I think the opportunity is on those both, bringing people in and then the people we have or patients we have on therapy to make sure they're on the right dose every day, every week, every month, and there's an upside there.
Yeah. Okay. So maybe shifting gears to TL1A, some point in fourth quarter, presumably we'll get a top-line update from that.
Yeah.
Phase two study. There's an extension phase to the study as well, where I think you're looking at bimonthly dosing, but the treatment period, which I think is 12 or 14 weeks, is like every two-week dosing period. And I know that the half-life is shorter than some of the other TL1A biologics. So will you have enough information by end of year to know what your dosing profile will look like, assuming that the study, you know, is satisfactory in terms of the profile that you want to move it into phase three with your partner?
Yes, 'cause that's how we designed the phase two to give us the information we need to go into the phase three. So I think, we're very confident that we can hit the ground running in 2025 in our phase three.
Mm-hmm.
You know, that's an interesting one because I think we've shown how fast we've been in phase two, and we want to keep that momentum into phase three.
Yeah.
That will be supported by Sanofi, which has considerable resource and expertise. You know, probably one of your questions is going to be, you know, where are you in this race? You're a third, a distant third. I don't think we're a distant third anymore. I think this peloton has got quite tight.
Yeah.
And we've got momentum, and we're already planning for our phase three, and we're working with Sanofi on that. So, we'll have all the information we need to pick our dosing. So we're confident, and we're excited about this 'cause maybe we won't be third, you know?
Yeah. I mean, I believe Roche is gonna start next year, so it sounds like you're kind of on the same footing, maybe for the number two position. I don't know how important you think order of entry is between one, two, three in a space like this.
I think, look, you'd always want to be first. I'm not going to pretend otherwise in this race. That said, if you're second by six months or twelve months, I think if you look at the data, it doesn't really make any difference. You know, I launched an oral drug into MS that was three years late, and it took the market. I think, Adalimumab was last to the market, and that showed what it could do. I think it's about the capability and the focus, and I think we have the right partner. We have. We're intensely focused on TL1A.
Mm-hmm.
As you've shown, as we've shown, when we have a commercial product, we know how to really go after it, and we'll do the same with TL1A. So I'd like to be first, but I think we're going to be within the range, and then it's about, you know, making sure we have the right penetration, and we have the right pre-launch work, and we have plenty of time to do that with the right partner.
One thing we've heard from physicians, even like drawing comparisons to, like, Humira when they went citrate free, right? And sort of the injection experience. Is it painful? Am I doing two jabs, doing one jab-
Yes.
Every two week versus every four week? You know, how do you think... Do you think these factors are going to be important in sorting through maybe kind of differential market share gains in the space?
Look, I think all product profiles do have an impact. I think the slight difference here, and we'll see how it plays out, 'cause we'll obviously spend a lot of time talking to physicians, is there such an unmet medical need here. Most importantly, they want efficacy.
Mm-hmm.
So that's the first and foremost, though, and the patients they're treating want efficacy. But I do think they will think about all of those things that surround giving the treatment and the receptivity of the patient. I think one of the things that's going to play out, my view is, is the neutralizing antibodies, because physicians will know in this disease area-
Yeah
... this is the start of a journey of many treatments are going to have to go on to it. So I want to start with the something that has the lowest level of neutralizing antibodies because we want to have optionality going forward. And clearly, our data demonstrates that, and our phase three data that we had in asthma shows that. So I think if it just comes to the TL1As, apart from the fact that I think we all have better targeting, specificity, and potency, the neutralizing antibodies, and in some markets I've been in, are an important part of a physician's decision-making criteria of what class, which drug and what class do I use first?
Mm-hmm.
'Cause I want to have optionality because this disease shows me I need optionality. So I think those things will play out. I think that'll be very important. And the other thing is, you know, potentially, but we know we're going to have a subQ injection, so that, I think that makes it, you know, very patient-friendly as well.
Okay. Another important, I guess, aspect of this class that we hear from physicians is: I don't need another drug that works great in bio-naive patients, right? You know, you've got so many classes of drugs now coming into the especially the colitis space. And so I think one of the things that really stood out with the Prometheus data was that it worked equally well in bio-refractory-
Mm-hmm
And bio-naive subjects. So I guess it's a long-winded way of asking, as we get the fourth quarter update, will we be able to discern these aspects of the drug, and even magnitude of treatment benefit, or will that be more of the first half 2025 detailed medical presentation, where we get maybe answers to those questions and how your profile stacks up?
I think, you know, at the end of this year, it'll be more top line. I think as Eric's communicated, I think when the full data's rolled out in 2025, that's when I think you'll have a more fruitful discussion on that.
Yeah. Okay. And then in terms of what's next for this class of drug and the partnership beyond IBD, I know that I think you framed this as a potential molecule that has pipeline and a drug sort of capabilities.
Yeah.
Have you guys been actively discussing new areas with that to explore? I imagine that the next step would be if you were to explore other indications outside that, some phase 2 proof of concepts at some point, maybe starting next year, presumably.
Yes. Look, we do believe. I think we've said it all the time that we believe that this has more indications, multiple indications, because of its mode of action. I think also our partner, Sanofi, believes this, believes the same, and that's why they were so interested in it, so we have been discussing those and actively discussing those.
Mm-hmm.
Which is also why I say when people say, you know, "Are you third or second?" I said, "Well, in the third indication, it could be first." Because we are looking at that seriously.
Yeah.
I do think that. By the way, not that you're gonna ask the question, but I'll throw it in here. You know, IL-15, we think the same way. You know, we're testing in celiac disease, but we think in vitiligo as an opportunity and maybe two other indications. And that's another thing that I don't think people have necessarily registered in our pipeline. They say, you know, have so many assets. I say, "Well, TL1A is two. Could it be three? Could it be four? Could it be five?" IL-15 is one, two, three. So our pipeline actually is bigger than people think-
Yeah.
If you take it indication by indication. And so I think that's another thing that I'd always like to highlight to people when they look at it and say, "You know, what's the depth of your pipeline?" So it's a lot deeper than you think if you actually look at it from an indication point of view.
Can you frame the IL-15 opportunity since you brought it up? You're gonna have some data here in fourth quarter. It's my understanding, it's a healthy volunteer-
Yeah.
sort of gluten challenge
Yeah.
type of study, and so how de-risking of a study, you know, a healthy volunteer in terms of what you can learn and how confident we can get that you have a drug? And I know others have explored IL-15-
Yeah.
and had mixed results so far.
Yeah. So firstly, I think what we've shown is we're really good at making antibodies and the engineering of antibodies. And so we've actually made the other IL-15s, and so we've looked at what they do in vitro, and compared them, and we know exactly. And we engineered ours to be better and more specific, and the things we did are similar to TL1A. You know, our TL1A is our third TL1A, so we kept improving it. So you're right, we'll have something in celiac disease, and that was designed to allow us to move forward into a full study with celiac if we get the right data. But we're also now looking at proof of concept in two other indications to be able to move quickly.
I mean, for me, when you have a multiple, an asset with multiple indications, you really have to move fast and go for it, and do things maybe slightly in parallel and slightly at risk.
Mm-hmm.
But that's when we get that data, and I think once again, I don't think people are necessarily gonna look at that when that comes out, but I think people are gonna, "Okay, what does this mean?" And we'll be able to show maybe our differences versus the other IL-15s, and we'll be able to show data like we did on the TL1A, but if you sort of surround this all, and even this conversation we're having, Jason, to maybe when we spoke in Q1 of 2023, it's all about an innovative pipeline, which is comparable to any of the players in the pharma industry.
Mm-hmm.
And it's all, and we're talking about performance in commercial that's comparative or better than anybody in industry. And you may, and I may be now encouraging you to, not that I'm asking you to, we haven't talked about generics. We haven't talked about debt, apart from leverage.
Yeah.
And so that's a very different company in twenty months than it was, and I think you're asking the question the right thing, 'cause those are the things that will drive value and sustainability. But that's a very different company in twenty months than it was, based on some really solid pillars around innovation. And when people say to me, you know, "Can you really become an innovative company?" Well, we are. We just never focused on it. So the efforts and the capability we have in discovery around antibody engineering, the work we have in taking schizophrenia products through phase III faster than anybody else has done, shows we do have this muscle, maybe atrophied a bit, but now it's a lot stronger.
I think all of these things excite me, as does MSA, as does our anti-PD-1 IL-2, which we'll have data on that. I think it actually comes in the first half of next year.
Mm-hmm.
These are great discussions to have and great opportunities to show that we have sustainable value creation and revenue growth going forward.
Okay, and then last branded question, then we'll jump to a couple generic questions here. But just observations with Astra's Airsupra launch, this seems like script trajectory is pretty interesting. You know, maybe revenue capture will follow, but you know, I think there's roughly 11 million SABA units out there as the proxy for the market here, and I think you guys have talked about this maybe being a $2 billion category, which implies maybe 20% of that SABA volume-
Yeah
... converts over to ICS SABA. So maybe just, you know, the work that you guys have done and maybe thinking of how much of the market would convert to ICS SABA. It seems like there could be an upside opportunity tied to this.
Yeah, so look, I think you framed it exactly the way we think about it. So firstly, we've talked about only 30%, 20%-30% converting, which is, you know, I'm pretty good on forecasting and projections and modeling. I really like-
Mm-hmm.
Doing that. It's my time. This one, we just said, "Let's be conservative. Let's just say it's 20." The reality is the guidelines say all of those should be, right, on it, so it should be 100%. Now, with AstraZeneca going first, this is another one where you always wanna be first, unless it's in this situation where you've got to create the market, and you know, a lot of respect for AstraZeneca and respiratory, and I think they will create a market. They're going after it, and I think they see those 11 million not converting only 30%.
Mm-hmm.
So we're gonna follow two to three years later, but our differentiation is we're just gonna be pediatric indication. You know, we can obviously go into adults. And so they create the market, we'll come in, and we'll say, "Well, 25% is pediatric, and we have a pediatric indication." And we have a different device as well, which is simpler to use than we think than the AZ. So we do have differentiation. We don't have to be going head-to-head and taking 50% of the market and trying to compete with them. What's good is they'll set the access, they'll set the knowledge, and they'll set the trend of using the this, and we'll come in.
I go back to what I said earlier, from a Teva point of view, that could really be really meaningful, that ICS have a contribution, and it comes in a similar time to IRA.
Yeah.
... So it's another thing that we'll have, we'll be talking about as we have conversations going forward. What is the actual size? How is that growing? And by the way, we do have experience in respiratory, so it's not something we haven't done either. So I'm excited about it. I got a lot more excited. When I came in, I was sort of dazzled by TL1A, IL-15, anti-PD-1, IL-2, and all of that, and I sort of like, I just thought, whatever. And then as I got back, I thought, actually, this is really good. It's de-risked from a clinical point of view because we know this product work. We know devices because we made devices for 30 years, and actually the market is big. Maybe it's a tiny bit unsexy, but I also respect AstraZeneca and Pascal, and they've put a lot of resources behind it.
I don't think they do that because they have lack of opportunity.
Yeah.
I think they do because they see something. I'm very excited and hopefully we'll have some more updates on that.
Okay.
So.
And then on the generic biosimilar side of the house, I think the whole resurgence of PBM biosimilars this year with you guys and Sandoz having seemingly pretty favorable updates. I know Cigna's been out talking about a lot of that private label really converting this year and then really converting in a big way next year, when the brand gets kicked off formulary, presumably like you're the only high concentrate interchangeable, the private label supplier there. So, get the lion's share of that. So how do you see kind of like this change in biosimilars? Is this private label mechanism, do you think kind of the way to go, as you think ahead to products like Stelara, Simponi, which are also going to be important follow-on launches for you?
How important has interchangeability been to getting such a high level of orders on demand?
So first, I'm really pleased by the change in the dynamic of the market. It's sort of sluggish, and now I think PBMs and payers have seen the value that biosimilars can bring. That said, it's still early days, you know. It's a very fragmented healthcare system in the U.S., and so, you know, each one has to move, and then they have to action it and change the formularies.
Mm-hmm.
But it seems to be heading in the right direction. I do think interchangeability does play in our favor. You know, but you have a certain size of the market that's going to be private label, and then you have a big chunk that's not going to be. So you can still have to work through the pharmacies and the traditional routes, and that's where interchangeability, I think, helps. That's where having a big portfolio, I'm going to bring five to the market before 2027, really also helps. So for us, I've always said I'm excited by the opportunity. The good thing about in our pivot to growth and our financial goals, you know, our biosimilar portfolio has been risk-adjusted because it is a dynamic market. It's heading in the direct direction, so we're pleased about that, and we're seeking to maximize it all the time.
but some of these things still need to evolve from an environment point.
One thing I've observed, right, like initially, there were tons of players in the space. It seems like we're weeding out some of the people maybe who don't have the fortitude for the space. It's a big capital investment, but as you think about winners and losers, and you talked about having a big portfolio of products, right? And you think about the learnings of having a generics portfolio with tons of SKUs, like how important will that ultimately be to success in this space, to have multiple, say, INN biologics, biosimilars?
I think it does play out. I mean, look, when we talk to people, I mean, we supply one in fourteen medicines to the U.S. I think it is something like that, right? So we work with these people on a massive volume, and so we've come up with biosimilars. They know us, they know our supply chain, they know what we can do. We know, we know the level of quality and professionalism we have. Now, that starts to play out in stuff as important as this.
It is to me that the size, scale, and reputation of Teva does play a part in this, but also there's a part where, you know, we want to participate in generics and biosimilars and complex generics, but we've set ourselves, you know, targets of where we're going to be mindful of price and mindful of discount because we're driving a growth trajectory. This is not about market share gain. This is not about volume gain. This is about the right contract at the right price that drives sustainability and an allocation of capital that gets a return.
Okay. We're at time. Richard, thanks so much for joining us at the conference, and hope you enjoy your meetings.
Appreciate it, Jason. Thanks very much.
Thank you.
Thank you.
... Hey, welcome back, everybody. Thanks very much for joining us for our first European company for the morning session on day two of the conference. So I'm Graham Parry from BofA's European Pharm Team. It's my pleasure to be able to introduce Julie Brown, the CFO of GSK. So we've got about forty minutes with Julie for a fireside chat and Q&A. So perhaps, Julie, I don't know if you want to start off with any kind of opening remarks on just you know, you're one and a half years now, I think, roughly into your tenure. So you know, what did you inherit? What do you think the key changes have been, and how are you on track to sort of meet those midterm objectives?
Thank you very much, Graham, and good morning, everybody. Delighted to be here to speak to you this morning. I mean, we've been through a significant change at GSK. I think, obviously, before I joined, we went through the demerger with Haleon, and, I think one of the major achievements with that was obviously the balance sheet was more secure in terms of future optionality for business development. And then the second change was we became a pure-play biopharmaceutical company, which allowed a degree of focus on the pharmaceutical business, together with the amalgamation of the vaccines business. So now a pure-play biopharma focused on medicines and vaccines. In terms of, you know, the journey so far over the year and a half, we have been really focused on really four things.
The first one is execution, and you will have seen the strength in the earnings and what we've delivered over the course of the last year and a half, two years, in terms of upgrading our performance and upgrading our longer-term outlooks. This year is also very strong, so we've recently guided very positively. We've had two upgrades recently. So the momentum of the business is strong, and I would definitely call out the specialty care momentum, in particular, as proved to be very, very good. The second thing is the pipeline. So we laid out an investor roadmap about a year ago now, actually, just over a year ago, which laid out the key milestones that we are measuring and watching, because obviously, as each one occurs, you get an inflection point in the sales projection.
I think Tony Wood, our head of R&D, has done a super job of clarification in research and development. And those assets, you expect some to fail and some to succeed, but those assets, you see largely a sea of green ticks that have come through from GSK over the last 12 to 18 months. The third area is capital allocation, and when I joined, I spent about the first three weeks just listening to investors and understanding their concerns and where they saw our opportunities. And in terms of that, we've been very clear about capital allocation. We've clarified the four therapeutic areas of focus. We've clarified our positioning in oncology, which is really starting with hematology and gynecology, gynecological cancers.
We've also been clear about our respiratory franchise, and you've probably seen us put increased emphasis on respiratory together with recent readouts in that area. So I think capital allocation is purely focused on the pipeline, the pipeline development, and also business development, improvement through business development in that pipeline. Then the fourth area is all about investors. We've been really clear about investor engagement. We've stepped up our engagement with congresses in terms of data readouts and also through not just the quarters, but the roadshows and attendance at the big meetings. Those four areas have been the focus. The longer-term focus is still very much on the sales growth, but also a competitive P&L. You've probably seen us put more focus on the margin. The accretion through the margin this year will be considerable.
Also, if you look at the period 2021 to 2026, the guidance means that we need to deliver 500 basis points of margin improvement over that five-year period, which is considerable. So yeah, you can see we're a team that has a strong commitment to what we've said to the market, and we're delivering on it, if not more.
Good, good. So then your midterm guidance, which you'd inherited, but then I think upticked slightly, is for 7% sales growth and greater than 7% sales growth and greater than 11% operating income growth between 2021 and 2026. So we're sort of midway through that. Consensus is already more optimistic and at 9% and at 13%. So perhaps, is there any areas of particular caution you're focused on? And what would be the threshold for you to, if you're performing more in line with consensus, to think about changing that guidance and addressing it and updating the market?
Yes. Well, I mean, as you know, we updated only eight months ago now. And I would stress as well that the guidance has been, you know, carefully considered, and we would emphasize that it's more than, so more than 7% on the top, more than 11% on the bottom, and progression to more than a 31% margin over that period by 2026. Obviously, there are puts and takes in any business, both through the R&D pipeline and sometimes commercial. And we think, you know, we're in broadly the right place at this point in time, but we clearly keep it under review. This year, we have upgraded twice, in terms of this year. We're now on 7% to 9% on the top line.
We're now on 11-13 on the profit. That's actually an incredible performance because this is the year we lose the Gardasil royalties. So actually, that means we lose six percentage points of growth this year due to Gardasil. So actually, what we're guiding effectively is up to a 19% profit growth this year on the back of 7-9 on the top line, which shows the considerable leverage we're getting out of the business because of that very strong execution and also a focus on ROI and delivery of the ROI in the business. So, I think it's a case of watching this space.
Yeah. Got it. Okay. And then, I think the other part of your long-range guidance is the $38 billion revenue 2031. Consensus has been ticking up on that as you've had some of the pipeline read out, so I think it's currently running at about $35 billion. But do you, where do you see the sort of key gap? Is it just, is it mostly pipeline or is it on, when you look across the consensus numbers, or is this the operating performance? Where do you, where do you think, Street might be, underestimating relative to your internal plan?
Yes. I mean, first of all, you can, you can get frustrated, but it's entirely natural that the Street is always usually below the company. And when you look at peers, it's the same. Because obviously we're tracking the assets as they're going through development, and we apply a probability of success, PTRS, as we call it, technical and regulatory success. And therefore, the market will tend to be slower than that because you're always waiting, usually for a phase 3 readout, and we totally, totally understand it. In terms of consensus itself, as you say, we've guided to more than $38 billion by 2031. That does not include Blenrep, and Blenrep, we recently had an oncology meet the management, and Blenrep we see as having potential of more than $3 billion.
First of all, there needs to be an adjustment for that. Consensus, Graham, as you mentioned, has actually moved $5 billion by 2031 during the course of the last twelve months, which we're pleased with that in terms of consensus is moving. We're also pleased with the fact that we've guided a stable margin through the dolutegravir patent expiry, and this was an area of concern for consensus, and again, consensus has moved up through that period. I think there is a good dialogue with analysts and also very much with investors in terms of the trajectory of the company. In terms of you mentioned, where is the gap, the gap between consensus and ourselves? The major gap lies in the pipeline, to your question.
Okay.
And the major gap within the pipeline lies within specialty care. And there are two aspects within specialty care, where the focus is in terms of the difference between ourselves and consensus. And the first one is oncology, and some of that is expected because we are still building an oncology business, and we've actually had a brilliant track record with Ojjaara. We recently launched together with Blenrep, potentially and generally lifecycle management. And the second area is respiratory immunology. And respiratory immunology, we've got a number of readouts that were not being picked up by consensus that have happened in just the last month. So Nucala, Depemokamab, have just both had readouts. And obviously, together with that, you've got Camipixant coming next year. So this is refractory chronic cough.
It will be the first asset in this class, given Merck were not successful, and therefore, consensus, understandably, is waiting for that phase 3 readout. I try not to get too frustrated, and I do believe as the readouts come, that this will come through.
Got it. Yeah, so super clear. So pipeline, predominantly on oncology, respiratory is, yeah, where you see the-
Those are the key areas.
Yeah.
Yeah.
Actually within that, is any of that, for example, new indications or expanded indications for Jemperli and the Ojjaara numbers, where I'd say, you know, recent performance has probably been ahead of expectations?
Yes, I think both of these are features. Blenrep is actually the largest difference, but you've also got Jemperli. We've got now increasing life cycle. We started in gynecological cancers. We're moving now into head and neck and other cancers for Jemperli. So clearly people are waiting for inflections on that. And then, yes, Ojjaara, Ojjaara's had a fabulous launch. You know, it's the highest performing JAK1 launch, in the industry, and I think people are gradually updating Ojjaara as they see the potential.
And then on the margin guidance that you alluded to, to keep margins flat through dolutegravir, loss of exclusivity. Obviously, it's very high margin revenue going away sort of 2028 through to 2030. To keep margins flat, just to be clear, that, that's basically because you think you've got revenue replacement from pipeline as opposed to big cost cutting or any kind of, you know, reallocation of the cost base?
Yes, it's definitely coming from the pipeline. It's definitely coming from sales, not cost cutting. Just to clarify with that, we are growing SG&A, but we've been through a cycle of double-digit growth in SG&A over a number of years. We have now reached a point where the majority of launches are going in the therapeutic areas, where we're already very strong, the four that we've already mentioned, and therefore the launches and the coverage, we can hold the SG&A growth rate at a lower rate than we have historically, which means you get the margin leverage. So that's the mechanic of what's going on. But you raise a good point about dolutegravir.
You know, Graham, as you mentioned, dolutegravir is a high-margin product, and the reason we feel confident we can hold the margin stable through that period is really threefold. The first one is HIV itself, and HIV has the ability to regenerate some of that business, largely because the market increasingly is moving to the longer-acting therapies, and those of you that know HIV patients, this means a huge amount to them because the stigma associated with the disease or the virus is considerable, so if they can move to a longer-acting therapy, and we've got every two months on the market at the moment with Cabenuva and Apretude, then people are moving, and there was a SOLAR study that was comparing once-a-day Biktarvy with Cabenuva, which is once every two months, and 90% of the people preferred Cabenuva.
So people want to move to long-acting. So by the time we get to 2028, is when the patents first start to go. It's over the period 2028 to 2030, then what happens is we're expecting 40% of our business to already be in long-acting HIV at that point. So there's a degree of protection, ourselves, and then we're moving now, and we've got very good data on Q4M, which means every four months, and then in the pipeline later, we've got Q6M. Each of these innovations means the patent expiry or the loss of exclusivity is extended further. So Cabenuva to be on the end of the decade and six, Q6M is beyond that. So this is the strategy for HIV. So that's the first one.
The second defense is obviously the GSK pipeline itself, and very importantly, we're pivoting the business more and more to vaccines and specialty care. And as soon as you pivot the business to vaccines and specialty care, you get an automatic uplift in those margins, because historically we've had quite a sizable gen med business. So that's an important second inflection point. And the third inflection point is the drive for productivity from SG&A. So we've put increased tools in place using generative AI, and we've now got the ability to have real-time simulations of marketing mix models that involve not just marketing data, but finance data, commercial data, marketing data, competitor data, and you can adjust real-time in terms of what is working, what is the marginal ROI, and what is the ROI. So if you're seeing marginal ROIs come through, that's when you change the marketing mix.
This is a big... I think we're leading edge in this now, and this is a big enabler for the business.
Okay. Interesting stuff. AI is becoming, I think, more commonly talked about in pharma, in SG&A as well as R&D now as well, so.
Yes.
Maybe just give some marketed products. So Arexvy obviously had a very strong launch. The RSV vaccine had a very strong launch last year. Early season prescriptions this year so far have been well below the level that we were seeing this time last year. So perhaps just talk through the dynamics of that. What's driving it? Is it confusion around ACIP changing the recommendation in June? Is it you just, you hit a lot of the low-hanging fruit last year, it's just harder to find people this year, for example, but perhaps just talk us through those dynamics.
Yeah, sure. Yeah, so you make a good point. The prescriptions this year are below where we were tracking last year. First of all, last year, as we guided in Q3, there was a large element of stocking in. You recall the conversations we were having this time last year. So we had around three million doses stocking in in Q3 in the channel. That level has reduced considerably as we've gone now. By the end of the second quarter this year, we had about 0.7 million doses in the channel. So there's a very different sort of stocking dynamic. The second point is, I think, ACIP have changed the position from where they were this time last year, as Brian alluded to.
Last year we had what was called shared decision-making, 60 to 74 age group, and ACIP have changed that to adults more at risk in that 60 to 74 age group. So there's going to be, I think, a level of complexity in understanding which patients are actually eligible. So that's brought an additional complication. Overall, though, in terms of Arexvy, we've also got a macro dynamic taking place with regard to ACIP's recommendation about vaccinations for COVID. So we've seen a big uptake in COVID vaccinations during the course of this period, somewhat understandably, given the dynamics in the U.S., but we've just seen about a tenfold increase in the vaccinations that are going in for COVID. So what this all means is we still believe there is a golden opportunity for Arexvy.
At the end of last year, Pfizer and GSK, we were the only two players in the market this time last year, and the penetration level of the market was 14%. So considering this is a deadly disease, it tends to affect over older adults and babies, but it is a deadly disease. It results in about 100,000 hospitalizations in America in this season and about 14,000 deaths. So it's a very serious virus, and therefore the penetration we'd anticipate overall, not being like a Shingrix, but being much more like flu, where you're dealing with a 60-70% or 60-65% penetration level.
So over the course of time, and I stress over the course of time, not, you know, immediately, but over the course of time, I think a strong vaccine with strong efficacy has a role to play in protecting people against RSV, protecting healthcare systems against RSV, and yielding a strong penetration level. So that's-
Mm-hmm.
You know, where we see our position.
The COVID interruption, do you think that's temporary, or do you think that we should be thinking about the total vaccinations in the second half of this year, and this season being lower than what we saw, you know, across the whole market, between both you and Pfizer?
Yes, we would anticipate that, and we, you know, we indicated this at Q2, that I mean, last year the launch was phenomenal, and there was a large element of stocking, which we called out. This year, because of the ACIP change, because of the surge in COVID vaccinations due to priorities that ACIP have decided are appropriate, we would see more pressure on that year-on-year position. Having said that, we still, you know, we've said we expect to achieve more than GBP 3 billion peak year sales. This is sterling for Arexvy, and we still anticipate that. But clearly, it's not going to be the same growth rate because of what we achieved last year.
Mm-hmm.
It was a phenomenal launch.
Yeah.
I think it surprised everybody.
Yeah.
Yeah.
Now you've created a high hurdle.
We did. We did.
And if I look at the split between you and Pfizer, obviously, they started contracting later last season. This season, you were all in the mix together with Moderna as well.
Yeah.
I think latest scripts are showing you sort of dropped to about 50% of the share, and Luke had said on the Q2 call that you'd contracted for market leadership. But is that sort of 50% where we should be thinking you're gonna sort of stay for the rest of the season, or is market leadership, you know, a sub-50% share number?
Yeah, well, according to our data, we're running at around a 62% share. So we're still beating Pfizer. As you know, we beat Pfizer considerably last year. Pfizer wanted to come back out fighting, but we're very pleased with the overall contracting position where Luke and the US team arrived at. Moderna, as you say, there's a third player in or a third boxer in the ring this year, which is Moderna. They do have, obviously, they're later to the party, but also their efficacy, their duration of efficacy has waned quite significantly. So I think their data was around 8.8 months, and it was down already to about the low 60% range. So that's a very different picture to both GSK and Pfizer.
So Moderna have got only a small share of the market. The major competition is really between ourselves and Pfizer, but we're pleased with the contracting. The performance through the contracting period has been strong. Pfizer, as we mentioned, we've got 62%. So what we're seeing at the moment with the scripts, I know you follow them weekly, as we do. The problem at the moment is more the COVID dynamic.
Yeah
... and probably the ACIP recommendation. Now, we've obviously got October ACIP coming up, and, we're preparing data packages associated with that. I think the agenda will be announced in the next couple of weeks, so we'll have a lot more clarity as we go through October ACIP, in terms of the trajectory over the next twelve, eighteen months.
So, is the strategy to try and preserve price and share, but ultimately try and preserve price and not, especially with Moderna coming into the market, see you know a race to the bottom on price here?
Yeah. I mean, we obviously wouldn't see a race to the bottom on price as a great strategy at all. We believe we've got an incredibly strong vaccine with very strong efficacy and duration of efficacy against a deadly virus. We saw last year as just the beginning. We're here for the long game, and very importantly, the focus has been, as usual, in the early stages, the U.S. market. As we move now into the subsequent years, obviously building an international presence, I mean, you've seen what we've done with Shingrix, the international presence. Over time, it doesn't happen immediately, it really builds. I mean, we would start with the private pay markets across Europe and international, and then you move obviously international immunization programs.
It's in our interests to know exactly the duration of efficacy before you go into those national immunization programs if you've got a very competitive, best-in-class vaccine. So that's our strategy.
Yeah.
It definitely wouldn't be price. In fact, we've been prepared to forsake price. The UK is one example of that, where Pfizer got the contract.
Mm-hmm. Yeah.
Yeah. So we're taking a long-term view of this.
Yeah. So basically, we should get data which gives you further updates on third season efficacy and duration. I think, you know, to me, the messaging seems to have shifted a little bit more towards, we've got a low GBS risk, Guillain-Barré syndrome.
Yes
... and a long-duration vaccine. But that would start pointing towards a vaccine that maybe doesn't need a booster next year. So when you look at your trend, your guidance for sort of growth in Arexvy next year and the three billion peak, does that assume boosters are happening, or do you now see this as more of a vaccine where you roll it out globally, but as the preferred vaccine in the market, but maybe boosters are either not happening or they're happening much less frequently than that?
I mean, I think we're in the process of analyzing the data at the moment, and there are two factors within this. You've got the efficacy of the vaccine, and then you've got the immunogenicity and whether the booster gives benefit. We do believe there is some waning. I think you've seen the data. There is some waning happening with regard to Arexvy. It's a different profile to Shingrix.
Mm.
So therefore, we would expect at some point there would be a booster. In terms of the forecast, the major factor besides boosting is the penetration level. And if you've got the potential for a best-in-class vaccine, and at the moment we're 14% penetrated, and we believe a flu type... This virus is very seasonal in the same way that flu is, and deadly in the same way that flu is. We believe that the penetration level can increase, will increase over time, and as we mentioned, you know, we're here for the long game.
Yeah, which seems the sensible strategy. I guess the challenge for that is as you look at 2025, if there's no booster, and you haven't really rolled out in Europe yet, you already. I think we estimate by the end of this season, you could be over 30% penetrated, which is where Shingrix sort of stops growing year on year. Is growth in 2025 on Arexvy then a real challenge?
I think we, you know, it's still early days. We've got a number of milestones coming. I think clarity of the data around second or third season is coming, and it will come before ACIP. It will be discussed with ACIP. So I think this is the first major consideration. And then our projection around our profile versus the competitors, we believe we're much stronger than Moderna, for example. Our profile versus the competitors and the penetration level. I think also virus or disease awareness is a big factor in this. You know, flu is really, really well established. Everybody knows the dangers of flu. We did major DTC campaigns last year associated with RSV. People, we raised awareness. I mean, prior to that, it was unknown, totally unknown.
I think that's why the launch surprised everybody in the way that it did. Again, we've got that activated again. This is where having three players in the party rather than two, is actually advantageous because you raise the awareness. So I think the penetration, the penetration level is the thing to now watch for-
Mm.
and separate out, you know, our competitive position versus macro factors, such as ACIP focusing on COVID this year and that type of thing.
Yeah.
I think this next few weeks is gonna be really important as we lead into ACIP and as we get the final immunogenicity data.
Yeah
-for Arexvy.
Got it. Okay, I might switch gears to Shingrix, because that's also been obviously a great success story, but it started to stall in the US. So do you think you can grow again in the US, or is this sort of now about just trying to find the pockets of the population that are harder to reach, but you know, year-on-year growth is gonna be very challenged in the US now?
Yes. So it's a good point. In terms of Shingrix, we're now around a 38% penetration level in the U.S. market. It is a different virus totally to RSV and flu. We wouldn't expect to get to those sorts of levels with Shingrix. The key thing with Shingrix is the growth is going to come ex-U.S. We've already seen the ex-U.S. position with Shingrix, whether it be Europe, whether it be Canada, whether it now be China with the Zhifei deal, that's where the growth is going to come from. The penetration levels now in the U.S. are reasonably high, and we are coming up against those harder-to-reach cohorts.
And we've pivoted the marketing approach, we've pivoted the targeting approach, more towards healthcare professionals that are associated with those difficult-to-reach cohorts. So we are doing a lot of work in terms of, again, the marketing approach to these groups of people. But I think basically, I would look for the rest of the world to be generating the growth in Shingrix. I think it's clear, we were clear about this. Week on week, the prescriptions are improving now in Shingrix. But compared with last year, if you look at week to week, it's improving, but you compare with last year, it's still down, and we would expect it to be down compared with last year as we go and finalize the third quarter.
Yeah.
Yeah.
And then in China, there was some sort of movement in the phasing of the deliveries to Zhifei.
Yeah.
Perhaps just to kind of explain, especially in that, because that coincided with a bit of a bloodbath for Merck in terms of their Gardasil. I think people sort of, you know, connect put the two together. So perhaps just explain specifically what was the inventory issue for GSK and how that did or didn't relate through to what we were seeing with, with Merck.
Yes. Yes, absolutely. So obviously, the relationship with Zhifei is brand new on Shingrix. They. I think they're a great partner, and they've effectively given us access to about 30,000 points of vaccination, as opposed to 9,000 and 9,000 that we had alone. So it's definitely a very good way to reach the market and reach the Chinese consumer. Clearly, the Chinese consumer has been through some turbulence on a macro factor. And you mentioned Merck. I think we're on a very different. We're in a very different time period than Merck. Gardasil is extremely well established. It's, you know, towards the end of its life cycle overall. In our position, we're in the early stages of the life cycle of Shingrix in China, and therefore, I think we would expect to see a different dynamic.
As you say, there was a delay in one of the shipments. Instead of going out in June, it went out in July. It was $97 million. It came through in July as we planned. So I think we keep it under review. We're not immune to the situation in China. Obviously, it's a private pay market and the overall macro dynamics there, and we keep it under review, and I think we'll have a much, you know, clearer update at the end of the third quarter as we go through September and into visibility in the fourth quarter.
When you say-
Yeah.
You're not immune to the dynamics in China, just maybe expand on that.
Well, just in the sense of, the consumer in China and the overall macro situation in China, they're obviously spending less in many areas, which are, you know, obviously vaccines in China are still, would still be a sort of discretionary, excuse me, a discretionary spend. And therefore, we're not immune to the sense that other sectors have been impacted by the macro-
Yeah
... position.
And then just to be clear, though, your deal with Zhifei, there are minimum contracted volumes, so they-
Yeah
-have to take $400 million this year, $800-
They do
... next year, and $1.2 billion the year after.
Yes.
Is there any scenario in which you wouldn't book that revenue out of Zhifei, and they wouldn't take those volumes, or is that set in stone in the contract?
They are minimum volumes, as you mentioned, but clearly, once, you know, we would take a long-term view with Zhifei in terms of the contract, and we would always take a look as we do with other parts of our business. We'd look at the sell-in, and we'd also look at the sell-out data, because it's in our interest and their interest, that the stocking levels are at the right level, so I mean, we have very close relationship, working relationship with them. Luke was out there just very recently, and I think we just keep it managed closely.
Got it. Okay. So, if the demand wasn't there, you wouldn't necessarily hold them to the four hundred this year, eight hundred next year?
I think it's probably too early to judge it.
Yeah.
They are minimums in the contract, so we've got every right to do it.
Yeah.
But I think with every partner, as you've probably seen GSK behave with other partners, we would take a sensible approach to it.
Yeah.
If there was a macro situation that they were dealing with.
Understood. And then, if I look at the European situation, so Germany had a fantastic initial launch there, that looks like-
Yeah
... it's more fully penetrated now, so which other markets, should we be focused on where there are new launch? I think you're just about to launch in France, for example.
Mm.
And will, do you think that that will be able to replace, I guess, the slowdown in Germany and actually still see growth out of Europe over this year, next year?
Yeah. Germany was a great launch and a great market for us. It was somewhat atypical across Europe because the penetration level in Germany, from memory, was around the 25, mid- to high-20s range. The majority of other markets across the world, it's a low single-digit %. So, and as you enter national immunization programs, that's usually when you see the big tick-up. So France is in that position now. So we are, we're very focused on growth in Europe. It's, and the rest of the world. It is a big opportunity for us, and we still believe that it takes longer. But Shingrix is an amazing vaccine. We've now got data to say that people only need to be vaccinated 11 years and still counting. So once people have had Shingrix...
If you haven't had the Shingrix vaccine, I would recommend it highly. I shouldn't be advertising things in this audience, but I would because you've got 11 years protection against a very painful rash.
There you go. I'm due mine now, actually. So there you go. Fantastic. I might just move on to Zantac, which has obviously been a thorn in the side for GSK over the last couple, two years or so.
Yeah.
Obviously, had some good news recently with the Delaware Supreme Court saying they take up the appeal on the original Daubert ruling.
Yeah.
Um, so-
Which is unusual.
Yeah, and it doesn't happen that all the time. So just perhaps run us through the implications of that decision, your confidence that you can get that decision overturned, and what the timeframe for that might be?
Yeah, sure. So as first of all, in terms of Zantac and our level of confidence, we have got extremely strong scientific data that shows there's no causal link between ranitidine and cancer. There is now 16 independent epidemiological studies that support that there's no causal link. And secondly, and this was a statistic that I wasn't aware of until the beginning of last year. Those 16 studies involved more than 1.2 million people. So these are not small studies. They're independent, and they're a wide range of people.
So I think the science that makes us believe very clearly that the science is on our side, but a number of us know the U.S. court system now in pharma and the litigious nature of it, and that it's a risk of doing business, unfortunately, in America. So we clearly won the first major case, which was the multidistrict litigation, which five cancer types went forward in Florida, December 2022, and we won that case, and the judge, Judge Rosenberg, threw out all of those cancers and said, "There's nobody outside this courtroom that believes there's any causal link." It was a very definitive judgment. We went to Delaware, just recently in January, Judge Medinilla, and she formed the opposite view. This was not expected, I think, by the market or ourselves.
We then appealed, and as Graham mentioned, we went to the Supreme Court and got the interlocutory appeal, which was unusual for us to get it, but now the Supreme Court is basically going to relook at the judgment by Judge Medinilla. She's since retired, and the cases have been handed over to another judge. In terms of Graham's question about the timeline, the hearings will be probably during the course of November, towards the end of the year, and then we would anticipate a judgment around the middle of next year. It could be slightly earlier than that. Obviously, depends on the scheduling. In terms of obviously a new panel of judges now will look at that scientific evidence and will look at the evidence from the plaintiffs and decide whether to take it forward or not.
So that's the next major milestone. In the meantime, of course, we are taking a very pragmatic approach to this because we know how important this is to shareholders, and we appreciate the impact this has had on the share price. We had a significant drop in the share price when the judgment came through at the beginning of June. It was around 7% off the share price. So therefore, we understand the importance of this, and we're taking a pragmatic approach. So you'll see, just yesterday, we settled two cases in California. Interestingly, though, besides the epidemiological evidence, in terms of the cases that have gone forward, two cases went forward, and we won them. Two cases at the final judgment stage, they didn't go through.
That was obviously the judge's decision, and then another two cases that were going to trial, the plaintiffs themselves decided not to go to the final stage. So there have really been now six cases that have been tested to the wire, and all six have been in favor of GSK. So we, you know, we watch this, and we work on this very hard. We've got a very small group of people. You know, it's obviously the Chairman, the CEO, myself, general counsel, looking at this, focused on the right strategy for this, and obviously dealing with an external lawyer group, and we continue to work on this in the interest of shareholders.
I guess, people always sort of hope for a settlement, but roughly 90% of the claims are sitting in that Delaware appeal decision-
Yes.
where an uptake on appeal is a fairly rare thing. So is there any rational reason why you would settle until you've, or come up with any kind of settlement until you've actually had that appeal ruling?
I think it's just a case of, you know, reviewing it, ensuring we've got the right strategy, working our way through it. As you say, we've got 79,000 cases, of which 74,000 are in Delaware, so very concentrated in that court system.
Good. And then in terms of the rest of the strategy, so California, I think you've managed to settle all of the individual bellwether cases. Do you see a difference in the different court systems? So California, settle. Illinois, you've actually gone to trial, and won a few. California is well known as a much more plaintiff-friendly state. So does that kind of play into the decision of where you settle and where you allow trials to go, claims to go to trial?
Yeah, it is a, you know, a risk-balanced approach. The court systems are different in the different countries or different states, I should say. Yeah, so, we're just being very pragmatic about it, and the thing that guides us, that's really important to us, is shareholders' interests. You know, we will be always acting in shareholders' interests.
Good. We're getting close to time, but a question I've been getting a lot recently is your HIV competitive dynamic. So we saw with Gilead, they've shown now some six-monthly dose lenacapavir-
Mm.
data in prophylaxis setting.
Yes.
Perhaps just help us understand how GSK sees that as a threat to, firstly, Apretude, but longer term, the potential for them to have a six-monthly dosed, treatment paradigm as well?
Yeah. Gilead first of all, as you quite rightly say, their product, Lenacapavir, is targeting the prophylaxis. It's targeting the prevention market, which is about 10% of the total market for HIV, so the holy grail with HIV is obviously the treatment market, which is 90% of the market. We are the only player with a solution for treatment, because you need the combination, and at the moment, Gilead have not got a combination, so the first thing is, Cabenuva has been on the market now for a number of years. It's got patent protection out to 2030, 2031. We've also...
It's every two months, which we see, as we saw, it's 90% preferred in the SOLAR study, and we've got the real opportunity now in combination with rilpivirine from Janssen to take it to every four months. So this is a major, major innovation. Lenacapavir, like we say, is for prevention, but also we believe there are nodules forming in the injection site, and this is an audience, obviously, that is very, very body conscious. So if you've got marks on your body that could last for six months, this is a major problem. So I think it's worth interrogating that lenacapavir data when it's fully available, both in men and in women, importantly as well. So we're confident in the HIV pipeline.
As I mentioned, we've got the two months, we've got a pathway to the four months. We would hope to launch the four months for treatment, for prevention in 2026, for treatment in 2027, and then we've also got a development program that is working towards a six-monthly solution, for HIV patients, which would be, you know, absolutely incredible if we could do that.
Great stuff. Well, the clock's telling me that we're out of time, so, thanks very much for your time today, Julie.
Thanks, Graham.
Thanks for being with us today. Thank you.
Thank you very much. Thank you.