Good morning and good afternoon, everybody. My name is Simon Baker from the Redburn Atlantic Biopharma team, and it's our great pleasure to introduce Luke Miels, the Chief Commercial Officer for GSK. Luke, thank you very much for participating. We'll move straight into Q&A because we've got a lot of questions to get through. So let's start with probably the most topical issue. I wonder if you could give us the latest update on Arexvy. The launch has been a fantastic success so far. So where are we now? How should we be thinking about this growth from a growth perspective into 2024?
Sure, Simon. So, yes, thank you. Strong launch. Actually, if I look at the most recent weekly data, we're still only off a little bit, by about, it's about 4%, so around 366,000 patients dosed, just last week. And, in contrast, flu was down 25% on the volume of the week before. COVID, around 19%. And, the competitor's RSV vaccine also dropped, slightly more than us, and we actually increased our market share to 71% of the volume in the retail environment. So it is following a trajectory that we expected in terms of being seasonal.
What we will know by the end of the year is what's the baseline, because of course, this vaccine can be used outside the season, and yeah, that'll be, that'll be interesting. Obviously, with Thanksgiving coming up this week, we typically see a drop in volume, but that should normalize the week after that. In terms of next year, I think we, you know, we're working very hard to build on that success in the U.S. We will have, obviously, another competitor in the form of Moderna entering the market next year. But we're working very hard to ensure we're well-placed there. We also have the 50 to 59-year-old data, which essentially shows equivalent activity to what we're seeing in the 60+.
So our aim is to have that ready for ACIP in June of next year, so that would give us the broadest label in that population, and really, you know, further arguments to stock Arexvy over the alternatives. And then, of course, we're continuing on the global launch, driving expansion outside of the U.S. So we'll add another 18 countries next year, and then, within the next three years, we'll be up to 60 countries, which is the core element of the opportunity for RSV. So, you know, good start. Still a lot of unknowns at this point. I think the key thing is we're not assuming this is a one-and-done vaccine. Our working hypothesis is this is about a two year coverage. We would be very surprised if we saw this extending into three years.
With that 50 to 59 addition, can you just remind us what the addressable market is in terms of numbers in the U.S.?
Yeah. I mean, I think, if you look at the total 50+, it's about 120 million to 140 million people. Now, we think the 50- to 59-year-old population is not going to be healthy individuals, it's going to be individuals at risk. ACIP gave some hints of that. And so, you know, in contrast to Shingrix, we think it'll be individuals at high risk of contracting RSV, so comorbidities, immunocompromised. So it's a smaller number, but, you know, still it's several million patients that we would add. But the main advantage is the fact that we've got a broader label. And so from the point of view in the retail and non-retail stocking, that adult population is just simpler for pharmacies.
If they have someone who's 52 that walks in, if they've got Pfizer's vaccine or Moderna's, they also need to stock ours, so it's about simplicity.
You talked about the rollout to an additional 18 countries next year. In terms of the rollout and the pricing, which I gather is broadly flat around the world, how big is that ex-U.S. opportunity? Inevitably, everybody's focused on the U.S. at the moment because that's where the action is, and it's traditionally the big market. But we've seen this with Shingrix, where there's tremendous growth now from outside the U.S. How should we think about the Arexvy opportunity internationally?
Yeah, along similar lines. I mean, You have healthcare systems that are heavily geared to flu vaccination and adult vaccination. Once you've navigated that initial approval, you're also seeing a liberalization of where vaccines are being delivered. There's some early signs in European countries, for example, to shift more adult vaccination into the pharmacy setting. I was in, actually, an emerging market the other day, where I was very surprised to see that they're working with pharmacy chains to expand that. So yeah, I think the ex-U.S, opportunity will be a sizable source of revenue in the next few years. We just need to navigate that national approval process and get on those tenders.
We're going to keep a very tight collar on the pricing, as we've done with Shingrix as well, because we're looking at this, you know, this is a multi-decade journey for this vaccine. We, you know, we don't think there's going to be superior RSV vaccines which become available. We don't think there's a big opportunity for triplet flu, Covid, RSV vaccines, so we need to take a, you know, a very long-term view in terms of the value for this vaccine.
Okay, that's very clear. And sticking on the theme of vaccines and going back to Shingrix, it has been tremendously successful in the U.S. The growth simply through penetration has started to slow down. But what is the remaining growth potential for Shingrix in the U.S? There are still a lot of people that could and should-
Yeah
benefit they don't.
Yeah.
So, where's the next leg of growth coming from? Is it purely-
Yeah
the annual age cohort, or is there more to it than that?
It's more to that, Matt, if you look at the total target population, we've still got about 80 million people who are within label that are not vaccinated, and yet typically 4 million people in the U.S. turn 50 each year. So we- it's a combination of those things, and I think we'll, you know, we'll see similar levels of revenue next year that we've been able to achieve this year. The other factor is that RSV and Shingrix are synergistic for each other in terms of the retail pharmacy setting. If someone comes in for Shingrix, there's the possibility for the pharmacist to also explain the benefits of receiving AREXVY and vice versa. So and we've worked actively with the pharmacy chains to promote that advantage.
Of course, if someone comes back in after their first primary shot of Shingrix, it's a second opportunity for them to be, you know, have the benefits for AREXVY outlined to that individual. So it's a combination of deeper penetration, about 33%. We typically could do about 1% incremental penetration each quarter. And now we're starting to restructure the marketing campaign to go to subpopulations within the U.S market that, historically, we've not had as target of the campaign. And when we've done that, it seems to work very well. And as you said, we've got the growth opportunity outside the U.S, which is going well. In Europe, we've signed, you know, broader access agreements in Japan, Australia, Canada. And we're early days in emerging markets.
You would have seen the deal that we did with Zhifei, a highly successful Chinese vaccine company, with agreed dose purchases. It's another 3.6 million doses into China next year that we have with that agreement. So there's a lot more runway here. And then ultimately, the two life cycle programs we're very interested in is one is just at what point do you see an exhaustion of the efficacy? We see about an 80% efficacy at 10 years. Next year, we get the 12-year data. At some point, we will see breakthrough in higher-risk individuals, either IC, but also potentially comorbid. So that's an opportunity with a booster to go back and recharge that population.
Then we continue to be intrigued by, you know, a series of signals in dementia, which is, you know, we want to explore that relationship and see if we can establish something. If we were able to do that, then, of course, you know, high risk probably won't work, but could be a very interesting outcome there for Shingrix.
On the revaccination point, is there any framework guidelines from the regulators as to when that is appropriate? Or is that essentially your call and payer's willingness?
Yeah, there's nothing in the context of Shingrix, so that's something we'd need to engage with the agencies on. And that's why we're very interested in getting the 12-year data, because we do see, even in the 10-year data, if you look at individual case studies, we start to see a particular, you know, the IC patients starting to see breakthrough events, which would make sense. Their immune system is compromised. Immune memory makes sense. So at what point is the threshold where that's high enough to justify the benefit-risk of rechallenging those patients with a booster shot? So I think we're getting close in the next 12-24 months, where we'll have enough of the picture to interact with the FDA, and then, if it's appropriate, develop a clinical program to reconcile that.
That's all very clear. Let's move away from vaccines. We've had the approval of momelotinib early this year or Ojjaara. I think by most common consent, the label was better than expected, line agnostic. How did it sit with your expectations?
Yeah.
How should we think about the ramp?
Yeah.
Indeed, in light of recent news, how should we think about the competitive landscape?
Yeah. I mean, when we were assessing, and trying to value Sierra Oncology prior to the acquisition, we always had a scenario. It was an upside scenario that we would get a line-agnostic label. And, but we didn't put that in the base case. And, and as we communicated to, shareholders at the time, second line is the baseline assumption that they should model. But we put the file in seeking, a line-agnostic label and, and did a lot of work behind that. And I think the broader clinical practice, indicated that there is a very high burden of anemia and subsequent requirement for transfusions, which we know is, you know, heavily correlated with poor prognosis and reduced life expectancy.
I mean, typically, someone who is not anemic at the point of diagnosis has a, you know, just under eight-year life expectancy. If they're heavily anemic, then it's around two years. So there's a high, highly disruptive element there. There's the burden for the patients. So I think the agency recognized that. And again, the program was really well executed by Sierra, building on the original work that was done by Gilead. So yeah, a good ramp so far. We have about 500 patients on already. They're a mixture of patients who salvage, who've been obviously treated with multiple agents in the past. There's a number of people who had come off ruxolitinib that have been reestablished on momelotinib, and then there's straight-out naive initiations. So it's quite exciting.
The reception's been really, really very strong, both in the U.S., and of course, we're seeing encouraging signs ex-U.S. So yeah, an exciting one. And I think a product, you know, all the market research we did as part of the assessment and valuation, it was very, very clear that hematologists recognize how disruptive anemia is for these patients, and it's, and they also could see the beauty of the mechanism, this ACVR1 effect on top of JAK, that helped to address that. So it, yeah, and I think with the BET data out in the last couple of days, I think also it makes things, you know, a lot clearer. You know, clearly, the FDA wants to see symptom relief.
And so I think, you know, with momelotinib, we continue to be in a very strong position for those patients who are anemic, who need a JAK inhibitor.
That's all very clear. Let's move on to a slightly bigger picture question, moving away from products. The relationship between the commercial and R&D organization in any pharma company is a delicate one that needs to be carefully managed. So if you could describe how it works within GSK, and how it's evolved under your leadership, and Tony's on the R&D side?
Yeah, sure. I mean, I've worked in companies where it's good and it's bad. I mean, I've fortunately, in my time at Roche and AstraZeneca, and now GSK, I've been privileged to work with, you know, fantastic R&D partners. And you're absolutely right, because, you know, any extreme situation, let's say commercial's too dominant, well, then the organization basically says, "Look, get me the 18th ACE inhibitor, and we'll give it to the sales force, and they'll do what they need to do with it," which that suppresses innovation. If R&D is too dominant, then you end up with, you know, innovative, interesting things, but they may have the wrong comparator. Typically, the dose is probably too low or the market opportunity's not there. So this healthy balance between the two is very important.
And I think what is critical on the commercial side is that the individuals that we place in roles where they're interfacing at the project level, with R&D, these are scientifically fluent individuals that are commercially credible, so the head of the U.S. will listen to them. But they have a comfort in a scientific environment and credibility there, so that they can influence the R&D organization and also vice versa. You know, within the R&D organization, individuals that understand the demands and the fact that ultimately we need to translate the clinical program into a level of differentiation to justify the investment. So I find you know, it's very easy working with Tony. We're both very clear about what we need.
This model was originally developed way back with Pascal at Roche, and then we replicated it at Astra, and frankly, we just, you know, copied it again at GSK, and it works.
To get to that situation, to where you are now, how has the organization changed much in the last few years?
Yes, a lot. I mean, I'll give you an example of the commercial organization. So, a lot of individuals that we're interfacing with R&D they were good people, but not necessarily our best and brightest, and so we've rebuilt that team. We have a rule that if you want to become a general manager in this organization, you must do a tour of duty, typically three years, working with the team that we call global product strategy. So that's the group that works up the TPP, that's the group that's involved in business development, and that is the group that works incredibly closely with the R&D organization and medical affairs to develop these products.
So these people are most capable and most likely to be able to provide direction to the R&D organization in terms of what's required. Tony, on his side, has made a lot of changes in his organization. He's de-layered it, he's simplified it. The governance is much faster. And then the other advantage is we have therapeutic leadership teams, so very, you know, compact individual teams, which is chaired by the commercial person. The R&D person is individual is the key partner, and then that's replicated at the broader R&D steering committee, which is co-chaired by Tony and I. So very flat structure. We know who the key project leads are. We can cut through if there's a problem pretty quickly. And yeah, this model works. We know that.
And now we've got it up and running in GSK, that should drive higher pipeline productivity in time.
Perfect. So innovation comes both internally and externally. We've talked about internal, but can you give us some insights into the current state of business development?
Yeah.
The funding environment for early stage still looks fairly dire.
Yeah.
There are a lot of biotech companies which are trading with very limited cash and even more limited scope for fundraising. So what does the landscape look like at the moment, and how has it changed over the year?
Yeah.
Are we, are we seeing improvements, or is it still?
Yes
still, for want of a better word, a buyer's market out there?
Yeah, there's still a lot of pressure out there. Of course, the good companies have... They, they'll get funding, and the good projects will get funded. It's the ones which are in the middle there, and obviously, the bad projects, everyone can see them, and they shouldn't get funded. But there are programs where you can take a bet and an educated risk. And, I mean, I wouldn't say we've got capitulation on the part of biotech boards in terms of, "Okay, we won't get funding." But yeah, it's definitely an attractive environment to do BD, and we're very busy. It's a big chunk of about 20% of my time I spend working with the business development team and with Tony and the therapeutic area teams, looking at BD opportunities where-...
You know, I think we're very strict and careful when we deploy shareholders' capital. To do those deals, we look for things which are, you know, there's really two buckets of deals that we try and do. One's like momelotinib and camlipixant, which we think are disruptive technologies that are going to address an unmet need, and we've really got high confidence that we have a best-in-class asset there, that may not necessarily be in an area that everyone's looking at. And then the second type of transaction we try and do are sort of smaller tuck-in deals, where we see, you know, very high value and something that's synergistic with our existing portfolio, and we think we can unlock value by completing that transaction.
That tends to be obviously at the lower end of the transaction scale in terms of, you know, capital deployed.
And what at the moment—what is the sort of limiting step? I mean, I suppose, you know, you know, at some point then that there's a capital limitation. But I suppose on a day-to-day basis, it's just a question of bandwidth and how many deals you can look at at the moment.
That's right. Yeah. Yeah. I mean, we have the capacity to do the deals we need to do. I mean, obviously, the most important thing is to improve your own internal productivity and your R&D activities, and there's a huge amount of energy going there. But yeah, to supplement your own internal innovation is very sensible. And yeah, so it's a bandwidth element, it's a quality element, and it's also just... Yeah, sometimes it's really just sequencing, thinking, "Okay, if we bring this program on, it's going to conflict with these other activities we have in that therapy area. Do we have the capacity at this point to do it justice?" And I think that's where discipline's important.
The types of deals we continue to look at are very much like camlipixant and momelotinib in that $2 billion range, not, you know, mega deals. Then the tuck-in deals are, you know, in the $ hundreds of millions, in that zone there. When you aggregate all of those things, I think we, you know, we're beginning to unlock some value. I think the result that we got with the FDA, with momelotinib, we have a new team in oncology for the last two years, this is their first deal that they executed. This is now the team that's working on BLENREP with DREAMM-7 and DREAMM-8. Frankly, candidly, they're the team that I worked with at AstraZeneca.
And so we've been able to reconstitute that team, along with the key person in business development from AstraZeneca. So hopefully, that judgment, you know, in terms of how DREAMM-7 and 8 have been designed, how we're doing BD development deals, the life cycle work we have with Jemperli, our PD-1, this will start to be visible to people. But yeah, we have the bandwidth and the firepower to continue to do more business development where we see value.
Right. No, that's very clear. Now in terms of the macro challenges and pressures on the industry, probably the biggest one, or the biggest one for years has been pricing in the U.S, and more specifically at the moment, the U.S Inflation Reduction Act. How, how does that affect GSK? Because there are potential positives and negatives there, in terms of price negotiation versus vaccine access. Netting it all off, how does IRA affect GSK?
Yeah, I mean, I think in the short term, it's a positive. Critically, the removal of the co-pay for seniors, for Shingrix and Arexvy, is very important. We know about a fifth of patients rejected a Shingrix shot historically because of co-pay considerations. Obviously, commercial patients did not have a co-pay, so that was something that was impacting older patients. And you saw the structural shift in the market with the recognition that vaccination was, is an intelligent usage of healthcare resources to prevent. And so, that has been definitely a benefit for us. I think, you know, clearly, we expect products like Trelegy to be in the negotiation in around the 2027 timeframe. So net-net, it's neutral to positive based on what we know today.
I think the important thing is if you look at when the Affordable Care Act came, Obamacare came in, it essentially resulted in about 10 years of stability for the industry. And so if IRA does bring in a degree of stability, then everyone knows the framework that they work in. I suspect there will be tweaks in time. I don't know that there was the intent of the individuals that framed the legislation to suppress studies in smaller populations in oncology, for example. So I expect there'll be some tweaks in time. But in the end, I think we can navigate the IRA. And the U.S. is still a you know a very encouraging environment and rewards innovation, and rewards innovation very well.
So, yeah, I think we're, based on what we know at this point, well-placed.
Despite the numerous legal challenges, you don't expect any major changes to IRA, either in terms of what it is or when it will come to pass?
Yeah, I mean, I think, I'm not a constitutional lawyer, and lawyers, of course, tend to give 50/50s, so let's see. But I think our, you know, our working—well, it's our working hypothesis is that the legislation, as it is, remains in place.
Right. Then the same question really for this side of the Atlantic. There are European Commission proposals for the pharma industry, especially around data exclusivity. And yesterday, the U.K, government announced changes to the VPAS scheme. How do both of those impact GSK?
... Yeah, I mean, I think the European legislation still has a number of evolutions. I think the industry association, of which we're members of, has been very clear in terms of the practical elements of that legislation and different access regimes within European countries. So let's see. I think this is going to take some time to emerge, and you could see a lot of adjustments over time. So I think it's one more to watch. In the U.K., this was very important to resolve. And our general manager for the U.K. was deeply involved and a leading member of the discussions there. So I think it was important to have addressed that. And, you know, other companies were on record in terms of their views on innovation.
So yeah, now we can move forward. We have clarity, and that's our intent.
Excellent. Let's go back to, to vaccines, but slightly earlier. How important commercially is the, the pneumococcal 24-valent vaccine? Not, not just in and of itself as a product, but in terms of how it impacts the, the commercial profile of the whole vaccines portfolio.
Sure. I mean, it's a very important product. For us, it was an important deal. I think what attracts me is we—if we originally were in the PCV market with Synflorix, and we're outmaneuvered by Pfizer and Merck, by the argument in terms of strain coverage, valency. And so we, you know, we didn't evolve Synflorix, and the market moved. And so that's where it struck me as an enormous opportunity in terms of, you know, still you've got around 60% coverage in adults with PCV20, Prevnar20. So there's a lot of headroom here to improve on that, and the entire market has been primed to expect every few years, broader coverage, for, you know, a similar, similar sort of price or similar value proposition.
So I think, us coming in with a 24- and then subsequently a 30-valent is a big opportunity, both just in terms of the technology in itself, because Pfizer has hit a ceiling in terms of the conjugation capacity, there. And we think we've got a very compelling proposition versus Merck, with their program there. So yeah, it's a big market. And also what we can then do in adults, but also pediatrics, is put that in our broader portfolio, particularly in pediatrics, having a wide range of products is important. The bulk of these vaccines are given in a non-retail, sort of in-office setting, so it's less important for Arexvy and Shingrix. But yeah, it's an important product, and I think one that's a multi-billion potential, as we've guided to before.
And do you think that the market and investors really get this point? Because I think there's a temptation to think that there's such a strong established incumbent in there, that it's gonna be very difficult for others to come in. But I mean, as you said, the situation was different originally, and Pfizer came in, and of course, with Shingrix, that came into a monopoly position-
Yep
and wiped away the opposition.
Yeah
given the differentiated offering, and as you say, the evolution of the market, is it effectively up for grabs in its entirety?
I think it is. I think it is. And the other example, which we had direct experience with, is the HPV market, where we were there with Merck, and Merck shifted. We had two, and then they brought in Gardasil 4, and then Gardasil 9. And so they have just completely changed the market. And I don't think there's any loyalty to vaccine brands on the part of physicians if there's a better opportunity to cover more patients. So if you look at our 30-strain, we can cover, Prevnar's about 60% efficacy in adults. We have the capacity with our 30-strain to cover, you know, nearly 100%, about more than 95% of strains, with the 30+ that we're developing.
That's a profound shift in efficacy, and I don't think physicians are going to hesitate to shift from the older technology to the more effective new options. I mean, it's completely rational. We're driven by data, as we should be. And if you've got a more effective vaccine and it's priced competitively, they'll shift. As you said, Zostavax, 50% efficacy. We bring Shingrix, Zostavax has disappeared. That's how it should be, frankly.
Yeah. And as well as the profile, presumably, you have no disadvantage in your ability to access those prescribers within the pneumococcus?
No. No, I mean, we are calling on those prescribers every day today with Shingrix and AREXVY, and we're also calling on them for- with Trelegy, for example. There's very heavy overlap with the, the patient population there. And, and then we see those pediatricians every single day with Boostrix and our full, pediatrics, you know, Menveo, et cetera, our full pediatrics portfolio, in the U.S. And of course, we're talking to the same payers in the European setting for the broader national immunization programs and the tenders there. So there's enormous synergies with our business, and that's why we, we thought we, we had been essentially ejected from the market by Pfizer historically with Synflorix.
So we've retained that knowledge and decided to come back in, and yeah, we do think this is a very large opportunity, and one that is ripe for disruption because of this ceiling on the conjugation technology that Prevnar has reached.
... Very clear. Now we may have partly answered this question with that answer, but I'll ask it anyway, 'cause I'm sure there's more to it than pneumococcal. But what do you see as the most underappreciated assets in GSK's commercial and development portfolio? It—I think with any pharma company, people—the market tends to focus on narrow segments of the portfolio. I certainly don't think that GSK is any different there. And my view is that you probably have more things which have been overlooked than many, but it would be great to get your thoughts on-
Yes
... what they are. Yeah.
Yeah. I think in the late-stage portfolio, camlipixant, the chronic cough medication, is... And I just think it's because there are no solutions today for chronic cough that are widely adopted, so people don't have fully established models. But the epi is quite striking. There's about, you know, 28 million people with chronic cough, more than eight weeks, and there is about 10 million people who have been coughing for more than a year, and have gone through, typically, on average, about five specialists before they reach a diagnosis. So there's a big opportunity in the U.S. You break that down even more, and you look at just of that 10 million, those that are being managed by pulmonologists at any one time, it's around 800,000 people in the U.S.
And, pulmonologist site, I think, is about a 3% satisfaction with current options. So this is a, this is a, you know, a very difficult condition. It's one that's typically, as I said, takes a long time to diagnose and a journey through the healthcare system, after things such as lung cancer and IPF and reflux are excluded. And so that one, I think, is a significant opportunity, and we've got a track record in building products, and in new areas, and we've done that successfully. And hopefully, we're about to, to, you know, show continuing in 2024 that we've done that with Arexvy.
That one, I think depemokimab, a long-acting IL-5, I think people tend to look at it as, "Okay, you're just going to cannibalize Nucala." I think that ignores a lot of analogues in the industry, where you bring in a long-acting product with a well-known mechanism. That is material upside. We still only have about a third of the eligible patients, even in the U.S., despite really high insurance coverage, being treated with biologics. That's in complete contrast to, say, rheumatoid arthritis. It makes no sense. And so I think a long-acting, twice-yearly shot to give full coverage for severe eosinophilic asthma patients is going to be exciting, and one that is going to be much bigger than Nucala. And we've shown with Trelegy that we can grow a product without cannibalizing our own business.
So in the late-stage portfolio, they're the two, the big ones. I think in the early-stage portfolio, one to watch is HSV. It's a therapeutic for genital herpes using the adjuvant technology that we have with Arexvy and Shingrix, but it's being developed as a therapeutic. And there could be applications for HSV one, as well. So that's definitely another asset to watch. So they're probably the main ones that people are not as aware of. And I think also Jemperli is getting quite interesting, in particular subgroups in colorectal cancer, MSI-high populations, and also the endometrial, gynecological cancers. They're the ones I think that people are probably underrepresenting in their models.
It's interesting you mention rheumatoid arthritis because if we go back to the advent of biologics in that space, these were seen as highly specialist salvage therapies prescribed by very few people beyond the real leading KOLs. And now they are incredibly widely used, standard of care within the primary setting. Do you think over time, biologics in the respiratory space could move maybe not as far as that, but we go from the severe to the moderate to the bit less moderate? And what's the real opportunity here?
I completely agree, and I can still remember working on Leflunomide, just being intrigued by the lack of shift towards TNF. And I think as you see physicians getting more comfortable, also, physicians who are in, you know, in the teaching pipeline that come through, and they, they're educated in academic settings, and that becomes just a standard proposition to employ these. You also see a proliferation of alternative mechanisms. You know, we have the IL-fives, we have-- obviously, Xolair has been there a long time with IgE, but, the TSLPs, IL-four, thirteen. So there's just a lot more commonality. And insurance is really not the barrier, it is, it is really physician, reluctance, to deploy them more broadly.
I think what is interesting is we've generated this data ourselves and are publishing this ability to intervene earlier in the disease and potentially move patients to remission. I think that could be the inflection point there, as well as just lowering the burden for the patient. And adjacent in terms of, you know, six shots a year, there could be a Part B medicine versus a Part D. In for older patients, and of course, in the commercial setting, there are certain advantages to physician-administered products as well, which are well known. So I think, yeah, it has the opportunity. And then the other important thing is with Nucala, it took us about eight years to get a number of indications in, and we still don't have COPD completed yet.
Our intention when we launched depemokimab was to get all the primary indications, you know, EGPA, HES, nasal polyps—all of these within two years of the initial indication in severe asthma, and the only one that's a little bit delayed is COPD, because we want to de-risk it with Nucala. But yeah, that's gonna have a big difference in terms of the utility for allergists, other groups to use it. And I think that's the other interesting thing, is allergists seem to be quite aggressive in using biologics, and also we're seeing ENTs and ENT surgeons being very quick to adopt these products in nasal polyps as we've generated the data there. So yeah, let's see what it's like in five years' time.
I definitely think, we're gonna be a lot, you know, more broadly used, and people are more comfortable with them, and in 10 years' time, it should be, you know, it should be the exception rather than the rule for these severe patients.
So having that broad range of indications within the respiratory setting is as important from a formulary and a reimbursement point of view, as we see in the inflammation space, where multiple indications really does make a difference?
Definitely. Definitely. It's simplification, and being able to be used more broadly, and of course, you know, allergists, pulmonologists treat patients with several of these indications. And, yeah, it's just simpler for the systems, simpler for the offices.
That's very clear. Another new product which has produced some excellent data recently has been gepotidacin. But again, I think that's probably something where the market's not given much to it, because historically, there's this unfortunate paradox that the better the data on an antibiotic, the smaller the sales, because it gets used for that rainy day that never comes.
Yes
... is that still the case, or should we think about this differently?
Yeah, I mean, it's very interesting. When we were looking at the phase III program and decisions for gepo, we spent a lot of time on this, and what appealed to me is if you look at a typical treatment hierarchy for uncomplicated UTI, it's about 13.5 million events in the U.S. Many of these women are drug resistant or intolerant. You see multiple events, you know, nursing homes, et cetera, and typically they're prescribed nitrofurantoin, which is, you know, pennies. It's off patent. And if they fail that, which a large proportion of them do, then the drug of choice at that point often is fluoroquinolones, and that's despite FDA guidance to say, "Don't employ fluoroquinolones," let alone some of the renal complications, et cetera.
So what attracted me to gepotidacin was that you could almost turn that argument on its head, because gepotidacin's only being developed in two indications. It's being developed for uncomplicated UTIs and drug-resistant gonorrhea. So a very, very targeted mechanism, limited use outside those settings, in contrast to fluoroquinolones, which are used everywhere. And so our argument's going to be, after the patient fails nitrofurantoin, you shouldn't be using a broad-spectrum antibiotic, which is typically the argument used to stop novel antibiotics being used. You're degrading fluoroquinolones. Resistance is increasing in the US and Europe in using these. You should be using gepotidacin, which is designed to reduce resistance emerging. We've got good data on that. And preserving fluoroquinolones for more severe infections beyond uncomplicated UTI. So that's the argument that we're mounting. We recruited the study very quickly. As you said, the data's good.
We just now need to obviously get approval, but that's our strategy in terms of guidelines and the argument. It's, yeah, it's about preserving broad-spectrum antibiotics by using a very targeted, specific antibiotic, which is only going to be used in uncomplicated UTI and gonorrhea. So it's very different to a novel broad-spectrum antibiotic, which, yeah, tends to be preserved.
Does it therefore offer a potential blueprint for further work in this area? Because GSK's got a very long history within the anti-infective space.
Yes. Yes.
Moving to a more niche indication model, rather than looking for that new standard of care, is that from a commercial point of view probably the way forward?
Yes, I mean, it's very interesting. I mean, the numbers are quite compelling. If we got a quarter of those 25% fluoroquinolone patients in the U.S., we have a blockbuster product here. So it is material. It's highly synergistic with the portfolio that we've assembled as well. And another example, to build on your point, is the deal that we did with Scynexis for Brexafemme. So it's an antifungal, because of course, antimicrobial resistance is not limited to bacteria. Fungal infections are very problematic and increasingly problematic. And then we also did another deal for a product called tebipenem, which is an oral carbapenem. So it's another argument.
If you look at complicated UTI, these patients require admission in many cases, and subsequently, when they're admitted, they may get hospital-acquired pneumonia or other infections, and they're complicated to manage. What attracted us to tebipenem, again, it was a very, you know, very good value deal, was the fact that these patients with complicated UTIs could be managed by urologists and infectious diseases physicians in the community and not require admission to a hospital. You can have a nurse come and supervise the taking of the oral dose. And that, you know, from a cost effectiveness, resistance, et cetera, and just the complications for the patient, it's also a really compelling opportunity. So again, where we can, in a disciplined way, find products that are gonna do something different in the antibiotic/anti-infectives area, we'll pursue that aggressively.
Do we see those arguments carrying dramatically different weight in different regions? What's the European perspective versus-
Yeah
versus the U.S.?
Yeah, definitely, definitely different arguments. I mean, the U.S hospitalization costs, et cetera, the system tends to be a lot more sensitive to that. Europe, it's more cost effectiveness and the comparators. So some of these, you know... We think there is a business for gepotidacin in, in Europe, but tebipenem is, is more of a classical U.S product because of the, the dynamic in terms of admission versus at-home treatment, in, in the U.S. And we think the effectiveness, is, is very strong because of the costs associated with admission for complicated UTI patients in the U.S.
Excellent. I think we've come up to time. So, Luke, thank you very much for a fascinating discussion and for participating in the conference. And thank you to everybody listening. Thank you.
Thank you, Simon, and thanks to everyone listening, for your interest in the company. Thank you.