GSK plc (NYSE:GSK) Goldman Sachs 43rd Annual Global Healthcare Conference June 13, 2022 5:00 PM ET
Company Participants
Deborah Waterhouse – Chief Executive Officer, ViiV Healthcare
Kimberly Smith – Head of R&D, ViiV Healthcare
Conference Call Participants
Keyur Parekh – Goldman Sachs
Keyur Parekh
Good afternoon, good evening, and thank you all for joining us. My name is Keyur Parekh. And hopefully, you can all hear me okay. Deborah, Kim, hopefully, you guys — both of you can hear me okay. Brilliant.
So thank you all for joining. As I said, my name is Keyur Parekh, and I cover GlaxoSmithKline for Goldman Sachs. I’m really sorry, I’m not going to be in-person this afternoon. But Deborah, Kim, thank you very much for joining us. . So by way of introduction, Deborah is the CEO of ViiV, which is the HIV business for GlaxoSmithKline; and Kim is the Head of R&D kind of for ViiV.
So Deborah, before we go into the Q&A session, just wondering if you want to kind of give us some introductory comments or thoughts on how you see the landscape for HIV therapeutics, and then we’ll go into some question and answers before we turn it over to the audience questions. But please kick us off.
Deborah Waterhouse
Great. Thank you so much. So it’s an exciting time for ViiV Healthcare. Three years ago, we launched the first-ever oral two drug regimen, which demonstrated viral suppression in both naive and switch people living with HIV. And then we moved from Juluca and Dovato, which are our oral two-regimens into a new era of long-acting medicines. So about 12 months ago, we launched a product called Cabenuva, which is every 2-month administration for the treatment of HIV. And then most recently, we’ve just launched a product called Apretude, which again is a long-acting medicine for the prevention of HIV.
So we’re really in a very productive period from an R&D and innovation perspective, getting new medicines registered, launching them and then ensuring that we successfully commercialize those medicines. And as those of you who saw the business investor update that we did last November, we’ve committed to mid-single-digit growth between — CAGR between 2021 and ’26. We’ve talked about a portfolio in 2026, which is a value of about GBP 6 billion, GBP 2 billion being in cabotegravir-based treatment and PrEP, GBP 2 billion being our two-drug regimen oral products, Dovato and Juluca, and then the other GBP 2 billion being our older products, primarily Tivicay and Triumeq.
And then as we look to the back end of the decade, we’ve got a very strong early development pipeline, which we believe will see us through the loss of exclusivity of dolutegravir. So it’s exciting today as we’re launching lots of new medicines, but fantastic to think about how the market will evolve and our innovation will deliver for people living with HIV or who would benefit from PrEP over the next 10 years and beyond. So that was all I was going to say to start, Keyur. Over to you for any questions you would like to ask us.
Question-and-Answer Session
Q – Keyur Parekh
So I think, Deborah, that’s a great place to start. And I think you’ve kind of partly answered my first question, which is just your thoughts on how do you see kind of the landscape developing over the next 5 to 10 years, kind of more broadly, not just for ViiV, but across the HIV kind of therapeutic landscape. I’m wondering kind of just if you want to tie that in with how much progress we’ve made over the last kind of 10 years or so, just a little bit of where have we come from? Where do you think we are going to in the world of HIV therapeutics would be great, please.
Deborah Waterhouse
Well, as a clinician, I guess, I should be turning to Kim to give that historical and future view. Kim?
Kimberly Smith
Well, I mean HIV treatment has evolved dramatically, I’d say, over the last 20 years where we started out in a period where you had to give individuals many pills a day in order to keep the virus under control. Those medicines were associated with a lot of toxicity. Well, recently, we’ve had — we’ve gotten to the point of having single pill regimens where a majority of individuals are just taking one pill a day. But still, some of those combinations were associated with a significant amount of toxicity, which is what motivated us to move towards to drug regimens.
And so dolutegravir-based two-drug regimens really sort of have changed the game a bit. And the reason that we were able to do that is that dolutegravir is such a potent, effective, well-tolerated drug that it didn’t need to be a part of a three-drug regimen in order to either achieve viral suppression in naive patients or maintain viral suppression in individuals who were already suppressed.
And so we established the two-drug reg where it could be effective orally. And then we had the fortune of having cabotegravir, which is an integrase inhibitor that has a long-acting profile. And so we’ve established that two-drug regimens can work, and that allowed us to develop Cabenuva, as Deborah described. And so we launched the very first long-acting therapy.
Now you might say, okay, first long-acting, is that a big deal? Well, I will say for people living with HIV, it is a really big deal because it does — what they tell us is that it changes their life. In our clinical trials, our pivotal trials, 9 out of 10 individuals, when they were asked if they preferred the long-acting therapy or their previous oral therapy, 9 out of 10 of them preferred the long-acting. And they said it was because it basically made them stop thinking about the fact that they were living with HIV every day. They stopped worrying about being disclosed as living with HIV because they were traveling and had to take their pills or they had their medicine in their medicine cabinet.
All of those worries, all of that stress, they talked about really that feeling like a burden lifted from them being on long-acting. And that is sort of game-changing for the field. And that’s led to a world where now, everyone who’s working in HIV and developing products is looking to develop two-drug regimens and long-acting regimens. That’s the reality.
Now when we first started talking about two-drug regimens, no one believed that we were going to be successful. I think we’ve proven folks wrong from that standpoint, and I think we’ll continue to do that with the importance of long-acting therapy.
Keyur Parekh
If you were to take that and kind of think of it commercial, well, I think kind of several investors we speak to think of HIV as a really important therapeutic area, but also one that is kind of broadly dull and boring, right? People see that as a zero-sum game. If you’re going to grow, somebody else is going to lose. So just kind of help us think about where we might be wrong, kind of your single-digit, kind of mid-single-digit growth outlook. Is that coming from greater penetration of certain markets? Is that coming from market share? How do you see the commercial landscape evolving over the next kind of three to five years?
Deborah Waterhouse
So I would think of HIV as two separate and distinct markets, actually. So in terms of treatment, you have got low single-digit growth from a volume and value perspective across the market. So as you characterize, Keyur, you’ve got kind of a cake, which is relatively fixed. So if you want to be successful, you have to take share from your competitors or switch within your own portfolio from older to newer medicines.
And so what we are seeing is that Dovato and Juluca, the growth in those medicines is more than offsetting any loss that we’re experiencing with Tivicay and Triumeq. So our share is broadly stable in the U.S. And actually, we’re gaining share still with dolutegravir in Europe, and I think we’ve gained 2.5 to 3 share points over the last 12 months.
And then the other part of the market is what we’re seeing with Cabenuva. So Cabenuva is a unique value proposition. It’s got a very — it’s built on a very strong patient insight, and that is where we’re gaining share. So overall, our share of the market is increasing because we are actually driving growth and share gain from the commercialization of Cabenuva.
Now we’re only in the second year of that journey. But as time goes on, you will see the materiality of Cabenuva increase. And still in the treatment space, you will see, I believe, Tivicay and Triumeq reduce in size, and Dovato, particularly, but also Juluca increase. But that is against quite a fixed market.
The big opportunity for me is all in PrEP. So why do I think that? Well, first of all, we’ve never played in the PrEP market. So for us, every script is a new script. We’re not taking share from any of our other products. We’re actually taking it from our competitors or we’re growing the market because we’re reaching populations that are most at risk of becoming HIV positive.
In the U.S., the U.S. government has an intent to end the epidemic by 2030 and reduce the number of new infections by 75% by 2025. Without the PrEP market expanding, that will not happen. So for 1.2 million people who are currently — who would currently benefit from PrEP, only 25% of those people are actually on PrEP. And they are mainly white men who have sex with men who have commercial insurance.
What the government and many of us in the field would like to see is a safety net for those who are uninsured so that they can access PrEP. We would like to see a much greater focus in the 48 counties of the United States where most of the new infections occur, and that is amongst black men who have sex with men and Latin x, men who have sex men. And so we would like to see a real change and believe actually, with the intent of the government, this will happen, that the market will expand significantly. And actually, we will have the opportunity to penetrate that market because we have a medicine that has two superiority studies behind it is 3x more impactful in men and 9x more in women. So therefore, we believe the uptake of Cabenuva is going to be very positive.
So we are really hopeful about the opportunity in PrEP. Market is growing fast. And by 2030, we believe the value of that market will be at GBP 4 billion to GBP 5 billion, whereas today, it’s at about GBP 1.5 billion. So two very different markets. One is a fight for share, and the other is about growing the market as much as taking share.
Keyur Parekh
And just on that kind of PrEP market, what do you think really needs to happen for that market to be penetrated and a lot better kind of to expand the number of people who are willing to kind of get on to these medications?
Deborah Waterhouse
So I think, first of all, we have seen in the President’s budget speech this year, he highlighted $1 billion over 10 years to create a safety net in PrEP. Now obviously, that has got to go from a budget speech into appropriated funds, but actually that will make a massive difference. I think we do need to work hard to ensure that those who would benefit from PrEP marginalized communities actually have access to care because many of these individuals do not have access to care. They’re not connected to a medical institution. And therefore, they don’t really know where to go to get the support that they deserve, actually. So I think there’s a piece about those 48 counties and how we connect people to care alongside, obviously, the safety net.
And then I think the third piece for me is companies like our own, but others in this particular marketplace, continue to invest heavily to make sure that people are aware that there is a PrEP option available for them, one that could fit in with their daily life and one which would protect them from becoming HIV positive. Kim, would you add anything to that?
Kimberly Smith
Well, I think you pointed most of the issues out, but the excitement around Apretude for PrEP, which is cabotegravir for PrEP, the excitement actually is quite helpful. Because of the fact that providers actually want to see a change in the trajectory of the epidemic, they want to see individuals consistently on PrEP in what — one of the challenges that has been the case with oral PrEP is individuals may start it. But over time, they stop adhering. So on average after six months or so, they stopped taking it just because it’s sort of difficult to take a medicine every day as a preventive medicine when you’re not necessarily having a risk exposures every day.
And so many of the studies have really just shown there’s lack of persistence in taking oral. So there’s an excitement around the ability for long-acting to actually consistently have people on PrEP and really change the trajectory of individuals becoming infected. And so the CDC and the government is very excited about having a new tool in the prevention space.
Keyur Parekh
Just kind of sticking with that PrEP market. We spoke bit about the U.S. but obviously also a very big opportunity outside of the U.S. and probably a bit less actually kind of penetrated compared to the U.S. Just what needs to happen ex U.S.? How big do you see that market being kind of that 4 billion to 5 billion sterling number in 2030, how would it come from ex U.S.?
Deborah Waterhouse
So 90% of that 4 billion to 5 billion comes from the U.S. In the U.S., 54% of people who are HIV positive are virally suppressed. And only when you’re virally suppressed, will you not pass HIV onto sexual partners. So in the U.S., 38,000 new infections, low levels of viral suppression. So the sort of the [indiscernible], so undetectable equals and transmittable doesn’t work as well here because of the levels of viral suppression.
If you look to other markets, so let’s look at Europe, they’re at 90, 90, 90. So they’ve got 90% of people with HIV diagnosed, 90% on treatment, 90% virally suppressor, much higher levels, and that means that treatment is acting as prevention. So across Europe, there’s less of a compelling case to invest in PrEP because the treatment as prevention is actually the cornerstone of how they’re managing the epidemic.
Then you’ve got countries such as Russia, China, Brazil where you’ve got 1 million people living with HIV, and each country has about 100,000 new infections a year. So we work — we will work in partnership with those countries to see how we could best introduce PrEP. But at the moment, there is no PrEP market in any of those three places.
And then for the least developed countries where a majority of new infections take place, about 1.7 million per year, sub-Saharan Africa. We go through the process that we’ve gone through with dolutegravir where we will offer voluntary licenses to generic manufacturers so that, actually, those countries with the greatest burden of new infections will be able to have access to cab for PrEP. So from a value perspective, 90% of it in my expectation will come from the U.S. in terms of how we’ve modeled it today.
Keyur Parekh
And let’s speak on what I think has happened over the last kind of two or three years is kind of COVID-19, and that’s kind of in a sense of coincided with when you were launching some of your two-drug regimens and obviously the long-acting regimen. Just talk to us about how you think kind of COVID impacted the switch market over the last couple of years. How far have we come back to it being normal? Where do you see that moving over the course of the rest of this year?
Deborah Waterhouse
So in the U.S., the market was significantly suppressed from sort of a dynamic market perspective. So NBRx was down about 40%. That’s come back up again. Now the newly diagnosed numbers are probably almost at pre-COVID levels, but the switch market remains suppressed, and it’s probably about 30% below where we would have expected to be in the U.S.
In terms of Europe, I was just looking at the numbers today, it varies slightly by country, but the dynamic part of the European market has broadly come back to pre-COVID levels. So it’s in the U.S. you see the most significant suppression, and it’s mainly in switch.
So how has that impacted us? Actually, Dovato has been okay because a physician wouldn’t see a patient face-to-face during COVID, but actually, they were willing to switch somebody from a three-drug regimen oral to Dovato over sort of a virtual consultation. So actually Dovato has done very well and will, in fact, hit GBP 1 billion this year, as I think we’ve communicated already. So Dovato was fine. Last year, we were setting up Cabenuva, the processes by which it would be administered, getting all the big health systems set up and getting the access for the product.
But at the same time, COVID was difficult because you can’t initiate Cabenuva virtually. You have to have somebody in the doctor’s office, and there were times during COVID where that just wasn’t possible. But I think if you look at the numbers from quarter one, we sold as much Cabenuva over in Q1 as we did in the whole of last year. And actually, we can already see from this quarter that Cabenuva continues on a strong upward trend.
So I think we’re in a good place. But obviously, we would like to see the switch market come back. And we believe by the end of this year, it’ll be back to more normal levels. TRx is absolutely on track and in the right place from a kind of a volume perspective. It’s pretty similar to pre-COVID, a little bit above, actually.
Keyur Parekh
We’ve also recently had kind of a label change for Cabenuva. Just how much of that is what you’re seeing in the first quarter of this year, kind of the lack of an oral lead in kind of the ability to start two months? So just talk to us about that part of the market, Deborah.
Deborah Waterhouse
Yes. So what’s happened this year is there’s three or four different things that happen with Cabenuva. So it’s every 8 weeks. We’ve got the license for every 8 weeks. You don’t need to have an oral lead in anymore. If you want to come off Cabenuva for whatever reason as a patient, you can average with any oral at all, which is much simpler than having to go on to an oral of rilpivirine and cabotegravir. And we’ve also got an expansion of our license to cover adolescents.
For me, the two that have made the biggest difference is you no longer need an oral lead-in, and it’s every 8 weeks because we know that many patients were waiting and physicians were waiting for the every 8-week license before they would initiate. And we’ve seen a real breadth of prescribing increase. So the number of physicians prescribing has increased 30% over the last three months. And we know that we’ve had people who are warehousing their patients because those patients were waiting for the every 8 weeks, and we’re seeing that flow through now. So it’s almost like you’ve removed two or three of the key barriers. And we’ve got 90% access. So actually, payer — any payer challenges have also kind of been lessened this year.
Keyur Parekh
So if you take a step back and kind of think of this maybe from the perspective of the next kind of two to three years, how do you see those two markets kind of evolving? So on the treatment side, how much of it do you think will be two-drug regimen? How much of it do you think will be long-acting? And correspondingly, kind of how much bigger do you think the PrEP market will be? And what are your assumptions on kind of share dynamics in the PrEP market?
Deborah Waterhouse
So we think that the two-drug regimens in the oral part of the market will continue to grow rapidly. And we will continue to generate data that positions Dovato appropriately versus its major competitor, Biktarvy.
In terms of the kind of the long-acting market, I mean, I think we are going to be on our own in that market for the next five or six years by the look of it. We thought we may have some competition around about 2025 to ’26, but it looks like it might be further out. So in terms of that particular market, we’re going to invest to grow out market ourselves and to make sure that we’re penetrating that market.
For Cabenuva, we think that the addressable market is about 15% of people living with HIV. So it’s almost like the first version of a long-acting. And therefore, the addressable market is limited. But we’re intending to build on that with an at-home that are self-administered, that broadens out the addressable market. Then an ultra-long acting every three months, that broadens out the addressable market. And then ultimately, we want to get to every six months. And we see the addressable market going from today about 15% to probably more like 30% as the decade evolves.
But obviously, it’s not just about what we are kind of — we have in our hand from an innovation perspective. It is also about the environment and what the U.S. government does to invest in a safety net in PrEP. So that’s kind of how we see the treatment market evolving.
When we come to long-acting, clearly, we need to see that PrEP market grow quite dramatically in order for us to fulfill our expectations. I don’t necessarily want to go into our specific share goals. But what I would say is by 2026, we’ve said that cabotegravir containing treatment and PrEP would be worth about GBP 2 billion. The split between the two we haven’t really called out mainly because it’s incredibly difficult to call out this early on in the journey. But we’re very confident in the GBP 2 billion. We’re just not quite sure which product we’ll be delivering which part of it.
Keyur Parekh
Kim, as you look at the competitive landscape kind of from a scientific perspective, can you give us your perspectives on kind of what excites you either kind of in your portfolio over the next few years or if you see some of your kind of competitors working on something that appears in being an exciting year?
Kimberly Smith
Well, I’m biased, but I do think we have the strongest portfolio in the field. And that’s really because we’re the leaders in long-acting, and we’re not resting on our laurels. We are building the next generation of long-acting. So we think the future of HIV treatment is long-acting. Deborah mapped out sort of our strategy.
So right now, we have Cabenuva. We think roughly 15% of the market is addressable with Cabenuva, but it can be expanded by adding other options. So one, we look to have new mechanisms of action to combine with cabotegravir that will allow more individuals to be on long-acting therapy. So Cabenuva is cab plus rilpivirine. Rilpivirine is in an RTI. That’s a class has been around for a long time. So some individuals have failed that class in the past. Those individuals, Cabenuva is not an option for them. So when we take cabotegravir and add a new mechanism of action to it, that expands the number of people who potentially could benefit from those long-acting regimens.
And so our plan is to develop two new target product profiles for treatment, self-administered, so where someone can have the medicine in their house and give it to themselves roughly once a month. Now who does that appeal? That appeals to individuals who aren’t necessarily looking for the privacy. They’re looking for actually more flexibility. They don’t necessarily want to come into the clinic every two months. They basically want to have more control of their treatment, and they want to come into the clinic every six months and be able to dose themselves at home, less people who are out to their families, for example.
So that’s one target product profile. The other target product profile is to get to longer than two months. So there are some individuals say, I really want long-acting, but every two months is not enough. I want it to be less frequent, and that’s where we’re looking to get to once a quarter or longer. And so that’s for a broad population of individuals. And again, it’s expanded by not being based on cab plus rilpivirine.
And so that’s how we see the market evolving. Now we have a number of products in our pipeline to be those novel mechanisms of action. We’re broadly neutralizing antibodies. And so we have a product called N6LS that is we in-licensed from the NIH. It is a very potent, broad, broadly neutralizing antibody. We will show proof-of-concept data on that product at next International AIDS Conference.
One of the other mechanisms of action in our pipeline is a maturation inhibitor, and we have a product that’s currently in Phase 2b. And then we also have two capsid inhibitors in our pipeline. So we have a broad pipeline. We look to see those new mechanisms of action combined with cabotegravir, and that will provide products to give us those target product profiles through the end of the decade.
But in addition to that, we have a third-generation integrase inhibitor. And it’s third generation because it has a longer half-life than cabotegravir, and it has a very — in the preclinical data that we’ve seen, it has a — we expect it to have a high barrier to resistance and to cover resistance mutations that could be generated by first- and second-generation entities. And so that product is where we see us going in the future as, again, the foundation of an entity and then adding a new mechanism of action.
So I think our pipeline really does lay out sort of a future of therapy, which is primarily driven by new long-acting agents, but that can address more than what we can get with the first generation long-acting with Cabenuva.
Keyur Parekh
And then can you just follow up on that, kind of can you give us some kind of time lines around some of those programs. I know you kind of said towards the end of the decade, but going to push you a bit more kind of the first read into you’re looking at, which is the at-home administration and then going to the long-lasting. Any specific time lines of either those programs?
Kimberly Smith
So we’ve targeted a self-administered combination in the ’26 to ’27 time frame, and then a little bit later, ’27 plus with the ultra-long-acting combination.
Keyur Parekh
And then for the third generation, kind of would you be looking to kind of trend to that similar development path as you did for Cabenuva? Or would you think for doing it multiple kind of Phase 3s across different partner regimens at the same point of time?
Kimberly Smith
Well, I think over the course of the next couple of years, we’re going to be able to narrow down the options that we have in the pipeline, but which ones are the best to give us that ultra long-acting combination to combine either with cabotegravir or the third generation entity. And so by the time we’re actually ready to get to Phase 3 with the third-generation entity, which we refer to as VH184, by the time we’re able — we’re ready to go to Phase 3, we’ll know exactly which partner is best to combine it with because that’s a product that we actually think that we might be able to get out to every six months.
Keyur Parekh
And then, Deborah, I think you mentioned kind of you’re originally expecting competition in the long-acting space kind of to the ’25, ’26 time frame that seems unlikely now has been pushed out. So your perspectives on kind of thing that’s been pushed out by 6 months, 12 months? Or do you think that’s kind of a much longer push out there?
Deborah Waterhouse
I’m going to ask Kim to comment on that because you’re following very closely the evolution of our competitor pipeline.
Kimberly Smith
What we know is that our competitors sort of teamed up to create a combination that they — their ambition was to have an oral monthly that could launch in 2025 and injectable that was every three months or so that could launch in 2027. That was lenacapavir plus islatravir. Islatravir has run into some toxicity challenges. And so its ability to be a long-acting agent is still to be determined at this point.
So I think that, that’s caused some significant delay in those time lines because, obviously, the — for those that aren’t aware, that product is currently on clinical hold and has been since roughly October. And so that’s delayed the ability to start to go forward with those studies. And again, whether or not that’s a toxicity that can be overcome is still to be determined.
Keyur Parekh
And that kind of — if you take a step back and think the kind of big picture, obviously, there’s a lot that’s been happening in the broader kind of therapeutic world relative to mechanisms of actions, novel modalities. Just as we think about kind of functional cure for HIV, how are you both thinking about where we are on the journey, be it using kind of new technologies, whether it’s mRNA, whether it is kind of vaccine-based, but just big picture thoughts on how far we are from functional cures for HIV.
Kimberly Smith
So the holy grail is to get to a cure in HIV, and I wish I could say that we were moving at a rapid pace. But unfortunately, it is a major challenge. So part of why it’s a challenge is that basically HIV essentially hides in cells and go dormant, and it becomes invisible to the immune system. And in order to cure it, you have to get that sort of latent reservoir to sort of turn on. You have to get that virus to come out of cells and then find a way to clear it.
Well, the process of getting it to go from being latent to being sort of active is likely to require a drug that will turn on a lot of activation, a lot of inflammation, and therefore, have a lot of toxicity. And given where we are in — with treatment and so much effective treatment, sort of the — sort of risk benefit in that cure space is really quite a challenge. We’re all still very committed to trying to get there. But again, it becomes very challenging if you think that it takes a significant toxic medicine in order to get the virus to come out and give you an opportunity to cure it. So I think that we’re still quite a bit away from a cure.
Now you might say, aren’t there a couple of individuals that have been cured? Yes, there are. There are a couple of individuals that were cured. They were cured because they had a malignancy, actually leukemia, in addition to HIV. And so they underwent bone marrow transplant to cure the leukemia, and they were transplanted with cells that were resistant to being infected by HIV, and that’s how the cure occurred in those individuals.
Well, obviously, that’s not something that’s scalable for the millions of individuals who are living with HIV. And so we still are quite a bit away. Now you asked about vaccines. And I do think that there’s a lot of interest in HIV vaccines both for prevention and therapeutic vaccines. However, again, this sort of — that latency is a major challenge. And so you’re still going to have to sort of wake up the virus and then follow it with a vaccine in order to be effective. And so far, we just haven’t seen success in that space.
So I think we’re still quite a bit away, but we and other really academic and other industry investigators around the world are working hard to try to get to a cure, but I still think we’re quite a bit away.
Keyur Parekh
Interest of time, I know its over the last few minutes of this information. So I’m going to ask my colleague [indiscernible] James to come and join you on stage to help us with kind of doing the Q&A from an audience perspective. So for everybody in the room, if you have any questions, please do raise your hands, and [indiscernible] will come straight to you for Q&A.
Unidentified Analyst
[indiscernible] you mentioned briefly earlier. If you could talk us to the Apretude launch and guided your long-term commercial expectations there?
Deborah Waterhouse
So we’ve just launched Apretude a few months ago, in January. I would say the reception from physicians and people who would benefit from PrEP has actually been extremely positive. And the thing that I think is very encouraging is the speed and the quality of the access that we’ve got from a payer perspective. So we’re currently just around 40% access achieved only five to six months post launch. And in fact, we had originally spoken to payers where they had said that they were expecting to put in some prior authorizations or other things that kind of would get a physician to probably think first about the oral PrEP before thinking about Apretude.
In fact, the quality of access has been very positive. We haven’t got any step-throughs, any prior authorizations. They’re just one small plan, which has got a tiny number of lives, but it’s been fairly open from an access perspective. And we can — we believe that, that will continue, and we’ll get to very significant high levels. So that’s a really good start.
I think over time, what we will see is we will be investing significantly in — direct to patients, really galvanizing people who would benefit from PrEP to actually go and seek the support of their physician. I think we will see the U.S. government really start to lean into the prevention landscape and really encourage in those areas where the largest number of new HIV infections are occurring, leaning in there to connect people with care in ways that they have not been connected before. And there’s going to be a huge effort there, and then obviously, having this concept of the safety net for those who are uninsured. That is what over time is going to ensure that, that market continues to grow.
There are competitors entering alongside also with long-actings. I mean I believe, as we’ve said, by 2026, we believe cab will be worth GBP 2 billion, split between treatment and prevention, but that is a very material part of our portfolio moving forward. But we know that our competitors are also going to be in that marketplace as well.
But that’s actually quite a good thing when you’re trying to build a new market, it’s almost better sometimes to have two players in there really pushing for growth and for expansion. And we are dreaming that by 2030, the market is worth GBP 5 billion to GBP 6 billion and that half the people who would benefit from PrEP, so about 600,000 people, are actually on PrEP, and that will be a fantastic achievement.
So we are extremely excited about the future and what PrEP can offer to people who would benefit from PrEP. So it’s a very exciting time to be in this space.
Unidentified Analyst
Clear. Anything from the audience now?
Keyur Parekh
[indiscernible] is waiting indirect. Perhaps just from that 40% in perspective for us. So if you were to compare the 40% access you are talking about to some of the other accesses you’ve had over the last three or four years, whether you were launching dolutegravir originally or launching dolutegravir just help us think about access number.
Deborah Waterhouse
We’d expected it to be a bit slower than that because you’re moving into a market, which is — has currently had a generic launch into it. And we had thought it would take us a bit longer. So that’s probably as fast as the uptake that we saw on dolutegravir in Dovato. And actually, that’s pretty speedy. And as I say, it’s not just the quantity of the access, but it’s the quality.
And that means that there is very broad and open access now in many parts of the U.S. for people who would benefit from PrEP through Medicaid, Medicare and commercial insurers, and that’s going to build over time. So that’s extremely encouraging.
Kimberly Smith
And it’s hard to argue against it given the superiority of the data. How can you argue for limiting individuals to a product when there was clearly very dramatic superiority across both two very large studies?
Deborah Waterhouse
Yes.
Keyur Parekh
Look, there’s nothing more from the audience. I think we have pushed the time. So Kim, Deborah, thank you very much.
Deborah Waterhouse
Thank you.
Kimberly Smith
Thank you.
Deborah Waterhouse
Thank you very much.
Unidentified Analyst
Thank you all for joining us. Really appreciate the time and enjoy. I hope you have had a good rest of the day. Thank you very much.
Deborah Waterhouse
Thank you.
Kimberly Smith
Thanks.
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