Ladies and gentlemen, a warm welcome to the GSK Q1 2026 results call. I'm delighted to be joined today by Luke Miels, Nina Mojas, Deborah Waterhouse, Tony Wood, and Julie Brown. In our Q&A session, we'll be joined by David Redfern. Today's call will last approximately 1 hour, with the presentation taking around 30 minutes and the remaining time for your questions. Please ask only 1 to 2 questions so that everyone has a chance to participate. Before we start, please turn to slide 3. This is the usual safe harbor statement. We will comment on our performance using constant exchange rates or CER, unless otherwise stated. I now hand over to Luke.
Thank you, and welcome everyone. Q1 performance was strong. Sales were up 5% to more than GBP 7.6 billion. Growth was driven by Specialty Medicines, which were up 14%, with vaccines also contributing, particularly through strong Shingrix sales. Core operating profit grew 10%, and EPS was up 9%. Cash generation was strong at GBP 1.4 billion. Our Q1 dividend declared today is GBP 0.17. Looking forward, we expect another year of profitable growth reflected in the guidance confirmed today. Next slide, please. In February, we set out our priorities to drive value. We've made a good start, but we've got more to do. In a minute, Nina will share progress on how we're delivering growth, including the launches of Nucala COPD, Extencia, and Blenrep. We're also assessing our pipeline on an ongoing basis.
The aim being to progress high potential assets more aggressively. We identify differentiated profiles that fit an unmet need or address a gap in the market, we will then and are using scientific courage to make decisions in an accelerated way. This includes internal development as well as BD. We're already making progress here with our assets in COPD, with our ADCs in oncology, and with efimosfermin alfa in MASH. We'll talk more about these and other high-value opportunities at Q2 results, and this will include an update on our HIV pipeline instead of an HIV-only event in June. Continuing to underpin this are our efforts to simplify how we work with greater pace, accountability, and focus. I'll now hand over to Nina.
Thank you, Luke. Please turn to the next slide. Commercial momentum continued in Q1, driven by Shingrix and strong growth for key products across our Specialty portfolio, which grew 14%. General Medicines was down 6% in the quarter, driven by declining sales of the older established portfolio. Trelegy performance did not offset the broader portfolio decline, as its growth in the U.S. was limited by increasing co-pay requirements due to Medicare redesign. These are especially pronounced in the first quarter and are expected to be less relevant in the rest of the year. As Luke mentioned, we are focused on the products that drive the most value, including new launches and growth contributors. Next slide, please. Shingrix was a key driver in Q1, setting a record for quarterly sales, delivering more than GBP 1 billion, up 20%.
Quarterly patterns continued with strong sales in Q1, driven by Europe, where sales were up 51% following uptake in national immunization programs and private market demand. In the U.S., where sales grew 12%, driven by inventory movements, including the launch of the new pre-filled syringe. Moving forward this year, we expect tougher comparators for Europe and Japan as most large immunization programs annualize. Further penetration opportunities remain with around 11% of the eligible population immunized in our top 10 markets outside the U.S. In oncology, Jemperli was again a key growth contributor, delivering GBP 232 million, up 40%, driven by significant overall survival benefit in endometrial cancer.
At the Society of Gynecologic Oncology, we presented data from a four-year follow-up of the RUBY study, which showed an overall survival benefit over time, with 66% reduction in risk of death for patients with the dMMR, MSI-H endometrial cancer. We look forward to the continued development of this medicine, including in rectal cancer, with pivotal results from AZUR-1 in the second half of the year. Next slide, please. Nucala also delivered double-digit growth in Q1 following its expansion into COPD in the U.S. last year. U.S. growth was driven by a broad COPD label and the halo effect on other indications. Total brand new patient starts are now at their highest level, growing 65% year on year. We are accelerating momentum towards market leadership in COPD with around 45% of market share.
COPD launches outside of the U.S., including Europe and China, have similar strong initial signals. For example, in China, we are already capturing around 1 in 2 new patients, representing a strong early launch in one of the largest markets globally with around 100 million people living with COPD. In the severe asthma space, our focus is now on Extencia, for which access in the U.S. is still limited ahead of obtaining the J-code. Severe asthma is an area where significant opportunity remains, as only 30% of eligible patients are receiving a biologic. The ultra long-acting dosing of Extencia is a key value driver with around 97% of patients preferring 6-monthly dosing versus current options. This is also valued by prescribers as they understand that longer dosing intervals lead to greater adherence and therefore better outcomes.
Currently, 65% of patients discontinue their short-acting biologic in the first 12 months. The next critical milestone in the U.S. is obtaining the J-code, which is expected early July, after which we expect access to be unrestricted. Next slide, please. Moving to Blenrep, our community-ready antibody-drug conjugate for multiple myeloma. Simple administration and overall safety remains a differentiating factor as 70% of patients are in the community, accessibility to competitor options remains a challenge. In the U.S., we now have a majority of use in the community, an important indicator of success as academic centers tend to be the early adopters. Our data showing an extended benefit versus standard of care is resonating, as is the simplicity of our REMS and coordination of eye care professionals. The number of U.S. HCPs prescribing is growing, with many repeating.
Outside of the U.S., we have second-line approval in 19 markets, most recently in China, and we are progressing with launches in all major markets, including the U.K., Germany, and Japan. With that, I will hand over to Deborah.
Thank you, Nina. I'm delighted to share another strong quarter of double-digit HIV sales growth of 10%, driven by our long-acting portfolio in Dovato. Demand and market share increased across all regions, most notably in the U.S., where sales grew at 15% with treatment market share outpacing the competition. In Europe, we continue to capitalize on our long-standing market share leadership position. Competitive execution is powering our portfolio transition to INSTI-led long-acting regimens, which consistently represent more than 70% of our total HIV growth and more than 1/3 of total U.S. sales. With treatment accounting for around 90% of the total HIV market, we're delighted that Cabenuva grew 31% in Q1, fueled by patient demand. We also saw accelerated switches from competitor products reaching 79% in the U.S. this quarter.
Apretude grew strongly at 44% in the quarter, withstanding impact from a competitor launch and reinforcing the importance of our more than 99% effective, highly tolerable, single-shot long-acting injectable for HIV prevention. We're outpacing the field with our patient-centered pipeline built on a foundation of long-acting integrase inhibitors, the gold standard of HIV care. For three times yearly Cabenuva for treatment, our Quattro phase III registrational study start is on track. We expect to launch in 2028. Building on the success of six times yearly Cabenuva, the first and only complete long-acting injectable for HIV treatment, we believe this potential option will establish a new standard of care highly desired by patients and doctors while doubling provider administration capacity. Our three-times-yearly Apretude for PrEP is set to redefine HIV prevention once again with registrational study data anticipated in H2 2026 and an H1 2027 launch.
We strongly believe this asset delivered through one injection with dosing frequency linked to routine sexually transmitted infection testing cycles has the optimal PrEP profile better aligned to patient and HCP preference. At CROI, we shared data underscoring the strength of our pipeline assets, which we are evaluating for twice-yearly long-acting injectable treatment, and we remain on track to launch by the end of the decade. Data for VH184, our first third-generation INSTI with IP protection through to 2040, demonstrated potential for twice-yearly dosing and an enhanced in vitro resistance profile versus Bic. Our capsid inhibitor, VH499, also showed promising potential for twice-yearly dosing. This differentiated asset is highly potent and has a low risk of DDIs. Data for our bNAb latibart showed high efficacy for three-times-yearly dosing when combined with monthly cabotegravir. We look forward to sharing twice-yearly data later in 2026.
As we advance our pipeline at pace, continue to deliver strong portfolio performance, and prepare for our 2 upcoming 3-times-yearly launches, we are well-positioned to manage the dolutegravir loss of exclusivity and drive sustained long-term growth. As Luke said earlier, we will share more about the HIV pipeline at Q2 results. I'll now hand over to Tony.
Thank you, Deborah. Next slide, please. In R&D, our top priority is to accelerate development to deliver new products to patients faster. As you heard from Luke, we've been taking specific actions to advance our most exciting opportunities. In 2025, we started 7 phase III trials with 10 more starting this year. We're making bold investment choices to drive value in the late-stage pipeline. For example, our pivotal second-line trial in small cell lung cancer, EMBOLD-301 for Risrez, our B7H3 ADC, is recruiting well. We anticipate the expansion of the Risrez program with a number of phase III trials planned, including in genitourinary cancers, which start later this year. Similarly, for Morez, our B7H4 ADC, we've recruited more than 200 patients into BEHOLD-1 and presented phase I data for ovarian and endometrial cancers at SGO earlier this month.
We have now initiated 2 phase III studies with 3 more scheduled to start recruiting before the end of the year. More on Morez in a moment. StrateGIST 3, the first phase III trial for velzatinib in second-line GIST, started recruiting at the end of last year, less than 12 months after acquiring the asset. A second phase III trial in a first-line patient population will start in the second half. Elsewhere in oncology at ASCO this year, we have 5 oral abstracts accepted for presentation, including data from the DREAMM-9 study, which will inform dosing strategy for newly diagnosed multiple myeloma patients. This schedule will be employed in DREAMM-10 and in PrECOG, an upcoming cooperative group study. In RI and I, we acquired efimosfermin alfa in May 2025, where our priority was to advance this asset into phase III.
Our two pivotal studies started last year, ZENITH-1 and 2 in F2-F3 stage MASH, and are recruiting well with the NEBULA program for advanced MASH on track to start later this year. Moving to pivotal readouts, we reported positive headline results for bepi during the quarter, which I will cover shortly, we have four further phase III readouts to come in the second half for Jemperli in rectal cancer, camlipixant in refractory chronic cough, Exdensur in EGPA, and our three times yearly pre-exposure prophylaxis for HIV. Our business development activities continue to complement and enhance our portfolio. In Q1, we announced two acquisitions, RAPT Therapeutics in food allergies and HS235 in pulmonary hypertension. Both have clinically validated MOAs and the potential to be best in class. These assets build on GSK's existing expertise in respiratory and inflammation. Next slide, please.
As I briefly mentioned, we've announced positive phase III data for our functional cure for chronic hepatitis B, bepirovirsen. The B-Well One and Two data show a statistically significant and clinically meaningful increase in the rate of functional cure, and the full data will be presented at EASL in May. This outcome is important for patients because chronic hepatitis B infection is associated with high rates of liver cancer and an increase in all-cause mortality. A recent U.S. epidemiology study in hepatitis B patients showed that loss of surface antigen was associated with an 89% reduced risk of hepatocellular carcinoma and a 62% reduced risk in all-cause mortality. Regulatory reviews for bepi are progressing well. Bepi now has breakthrough designation in the U.S. and a PDUFA date of the 26th of October and has been accepted for priority review in China.
Commercial preparations are underway in these two markets, which represent around two-thirds of the commercial opportunity globally. Next slide, please. Turning to pipeline progress in oncology and our global BEHOLD-1 phase I study of mocertatug rezetecan in advanced endometrial cancer and Platinum-Resistant Ovarian Cancer. mocertatug rezetecan is a B7H4 targeting ADC, and B7H4 is overexpressed in many gynecological tumors with low expression in normal tissues. In this dose escalation study, mocertatug rezetecan showed encouraging antitumor activity. At the highest doses, confirmed ORR was 62% in PROC and 67% in advanced EC, with responses observed regardless of B7H4 expression. Durability of response data were also encouraging. In the highest dose PROC cohort, only 1 patient from 21 progressed within 6 months. mocertatug rezetecan was generally well-tolerated with low discontinuation rates and incidence of ILD. Only about 3% of patients reported mild to moderate pneumonitis.
Based on these exciting data and additional data from our partner Hansoh, we plan to start five pivotal trials this year in EC and OC. Next slide, please. Elsewhere in oncology portfolio, our partner Hansoh presented new Risrez data at a plenary session at AACR earlier this month. The data are from a Hansoh-sponsored phase I study called ARTEMIS-101, which looked at Risrez in combination with PD-L1 in 40 patients with second-line plus non-squamous, non-small cell lung cancer. The data show a 47% ORR with a median PFS of 14 months. The combination was generally well-tolerated with grade 3 adverse events, mostly reflecting hematological toxicity consistent with similar ADCs. Four cases of treatment-related ILD were reported in the study, and these were grade 1 or 2.
These exciting data were used to support the start of a phase III non-small cell lung cancer trial in China, and we plan to initiate a phase II study for Ris-Rez in combination with Jemperli in a global population. Next slide, please. As I mentioned, accessing innovation through BD continues to be key to acceleration and growth. In February, we announced an agreement to acquire 35Pharma. Their lead asset is HS235, a potential best-in-class, clinically validated Activin signaling inhibitor to treat Group 1 and Group 2 pulmonary hypertension. HS235 is currently in phase I development. PH is a progressive and life-limiting disease with high symptom burden and suboptimal patient outcomes. Five-year survival rates are around 50%. This is an underserved area in cardiopulmonary medicine with few available disease-modifying treatment options and significant growth potential.
HS235 has the potential to treat patients while reducing bleeding-related side effects and providing metabolic benefits versus existing therapies. Entering cardiopulmonary disease complements GSK's commercial footprint, providing new opportunities to achieve broader coverage across the multiple chronic diseases which affect the lung, liver, and kidney. We successfully closed the transaction on the 15th of April, and look forward to moving this asset into phase II development at pace. I'll now hand over to Julie.
Thank you, Tony, and good afternoon, everyone. Next slide, please. Starting with the income statement for the quarter, sales grew 5% and gross margin improved 110 basis points due to the growth of Specialty Medicines and Shingrix benefiting product mix this quarter. SG&A declined 2%, helped by positive IP settlements. On an underlying basis, SG&A grew 2%, demonstrating P&L leverage and continued productivity improvements. R&D spend was driven by accelerated investment in the pipeline, including the efimosfermin alfa and velzatinib pivotal trials. We will continue to invest in R&D as we initiate multiple late-stage trials across our Specialty Medicines portfolio. Royalties benefited from Abrazo and Comirnaty income streams. Operating profit grew 10% in the quarter, including the legal settlements, which were worth 3 percentage points.
EPS grew 9%, impacted by a higher tax rate and increased finance expenses, partially offset by the benefits of the share buyback. Next slide, please. Turning to the cash flow and capital allocation. Cash generation was strong, albeit partially masked by the impact of adverse currency. CGFO was slightly ahead of last year, with increased operating profit and IP income from the CureVac settlement, broadly offset by the timing of trade payables. Free cash flow benefited from the $250 million special dividend received as part of the changes to the ViiV shareholding structure. Looking ahead, we remain on track to reach our target of more than GBP 10 billion of CGFO, with cash flows weighted as normal towards half 2. Next slide, please. Strong cash generation and strategic actions have supported our capital allocation priorities with net debt at 1.4 times EBITDA.
Investments in BD primarily comprise the GBP 1.4 billion up front to acquire RAPT Therapeutics. Shareholder returns totaled over GBP 0.9 billion, the share buyback is on track to be completed at the half year. In the second quarter, we expect to have an outflow of $950 million for the acquisition of 35Pharma. We are optimizing the portfolio and generating cash income to reinvest in the business, including the ViiV special dividend, the divestment of the Rockville manufacturing site, and the out licensing of linerixibat. These transactions will positively impact net debt by $1.2 billion in the first half, including linerixibat completed in Q2, yielding $400 million. Next slide, please. Looking to the full year, we are confirming the guidance shared in February.
In terms of phasing, we remain on track for our full year product group guidance with a few things to note. Vaccines growth in Q1 benefited from the U.S. Shingrix prefill syringe stocking. From Q2 onwards, we will begin to annualize the publicly funded programs in Japan and certain EU countries last year. Gen Med growth is expected to be half-two weighted. Notably, in the second quarter, Trelegy has a tough comparator due to prior-year true-up benefits and international markets are expected to remain challenging. We still expect operating profit growth to be predominantly half-two weighted given the phasing of productivity benefits. You'll recall we will also be comping the RSV IP settlement received in Q2 last year. Next slide, please. Turning to our roadmap, which shows our commitment to deliver.
We've made a strong start to the year in terms of execution, pipeline, and disciplined capital allocation, including the acquisition of 2 new high-potential assets. With that, I am happy to hand back to Luke.
Thanks, Julie. In summary, we've made a good start to 2026. We're completely focused on managing the business to drive top line growth and accelerate the pipeline, and we're committed to taking the critical steps needed to do this. We look forward to updating you more at our Q2 results in July. Thank you, and we'll now move to Q&A.
Thank you, Luke. I'd like to remind everybody to limit yourselves to ask one question, please. This will allow more time for everyone to ask questions. First questions comes from Kerry Holford. Kerry, please go ahead.
Hi, Kerry.
Hi there. Thank you for taking my question. Nina, please, one for you on Extencia. On the slide you showed, you talked of around 65%.
of patients discontinuing short-acting biologics in respiratory within the first 12 months. That seems higher than I might have thought. I'm just interested to see if you've got more detail on why those patients are discontinuing. Does it relate to efficacy, safety, perhaps compliance difficulties relating to the monthly dosing? Also, what happens to those patients who discontinue? Do you see them return? Thank you.
Great. Nina?
Yeah, sure. Terry, there are a number of reasons, but one of them, and a significant one, is compliance and the requirement for frequent dosing, which as you know, varies from every two weeks to every four weeks for short acting. What happens to those patients, they will usually go back to inhaled medicines, and some of them eventually might come back again to a biologic. I'm not sure what that proportion would be, but we usually characterize patients who have not been on a biologic for 12 months as new to biologic. In a nutshell, a number of reasons, compliance being a really significant part of that.
Thanks, Nina. Next question.
Next question comes from Zain Ebrahim. Zain, please go ahead.
Thanks a lot for taking the question. Zain Ebrahim, JP Morgan. My question is on the strategy update that you're expected to provide with the Q2 results. Just what could we expect to learn from you there in terms of your pipeline? How much emphasis should we expect from you on the midterm outlook to 2031 versus the longer-term outlook beyond 2031? You've made comments at Q1 about, or Q4 even, about the HIV business, and we've seen the six-monthly data since then. Could we still expect you to provide an outlook on how HIV might look in 2031?
Sure, no worries, Zain. I mean, we've obviously been very busy. There's been a very aggressive prosecution of opportunities to accelerate the late stage pipeline. I direct you to the bottom right-hand corner on slide 13 in Tony's presentation. I think it's a good summary of it. Yeah, I think the timing made sense at that point to take more time to lay out the whole portfolio, both in terms of things that we can do that have midterm impact, as well as longer term impact. HIV will be embedded within that because again, we want people to look at the total business in aggregate and the progress that we're making there. Yeah, I think that's a good summary at this point. Thanks, Zain.
Thanks very much.
Next question comes from Graham Parry. Graham, please go ahead.
Great, thank you. This question on bepirovirsen. The PDUFA's coming in October. You've got data coming at EASL. Perhaps you could just outline the opportunity you see for the molecule. Do you see it more as a high price U.S.-centric asset or lower price, high volume asset across China? Can you achieve differential pricing across the regions? On label expectation, are you expecting a label for the broad population or just the low hepatitis B surface antigen group, think it's less than 1,000 international units per mL population that you flagged in the headline press release, has better functional cure rates? Thank you.
Sure. No worries. Nina, do you wanna go? Maybe Tony, if you go into it.
Yeah.
the data EASL, reg pathway, and then we can get it to the IP.
Yeah. Graham, I'm not gonna get into the details of the label, just to remind you that the B-Well 1 and 2 studies were chosen from the population that had a surface antigen level of 3,000 or less. I think it's important to understand that the complete B-Well population will cover that broader group. That's about 65% of the IDT population. The 1,000 group is about 45%. As I've said in the past, you know, the data we have suggests that there is a relationship between surface antigen level and outcome, but you shouldn't interpret that as being a linear one.
Yeah. I mean, the other thing I'd add, before Nina, if you wanted to add anything else, if you look, the 1,000 cut off surface antigen is about 45% of the population. U.S. patients, the bulk of them are vertically infected. It's around 1.2 million, of whom about just over 300,000 are on treatment today. Europe's a little more in terms of 1.4. Yeah, about 200,000 on treatment. China's much larger in terms of 57 million sort of infected, but only 16 million are diagnosed, and they have much greater usage of pegylated interferon there. Yeah. I mean, the treated population's around 10 million. You know, what we're being thoughtful about is particularly the strategy in China. I think the strategy in the U.S. and Europe is very clear.
What we're reflecting on, very actively is the pathway to launch in China. Nina, anything you wanted to add on that?
Yeah, maybe I would just say this. The way we think about is the way we see the opportunity, about 70% of the opportunity are between the U.S. and China. As Luke Miels mentioned, U.S. in hundreds of thousands in treated patients, diagnosed are probably only about one-third of the total. The way we see the opportunity now reflects really those patients who are currently treated. Those are patients who have high desire to be treated. Again, still, in the U.S. U.S. market is highly focused on relatively limited areas. There are about five states in the U.S. where hep B is prevalent and treated, and these are unsurprisingly states that have relatively high number of immigrants from Asian and African countries.
Those who are treated clearly have access to treatment. This is unlike hep C. This is patient population that have insurance, that have means to be treated, and then have desire to be treated. That gives you a little bit sense about where we are going and how we are going to approach it. It's quite focused area geographically. In China, about 70% of patients, or patient of potential market potentially is in about top 15% of the accounts. Again, very focused approach in a country where hepatitis B is considered to some extent to be a stigma with very high desire of treatment. That's why you have very high use of interferon, which is not a pleasant drug to be on for a very long time.
Luke, just one more. Graham, one final point to finish off. We remember we said before that 15%-20% functional cure across the population would be considered clinically meaningful, and that's sort of reflected in the expedited designations that we're getting, including the most recent one, obviously, from the FDA.
Thanks, Graham. Hopefully we'll see you at EASL. Next question, please.
Next question comes from Rajan Sharma. Rajan, please go ahead.
Thanks for taking my question. Just one on HIV, and obviously we're expecting some competitor data for a once-weekly oral treatment option this year. Some of the physician feedback that we've had suggests that there'll be strong demand for that. Deborah, just wanted to understand how you think about that from a ViiV perspective, in terms of near-term impact, and then ultimately, do you think that that is restrictive to a ultra-long acting injectable? Thanks.
Thanks, Rajan.
Yeah, thanks, Rajan. In terms of the once-weekly oral that's being launched for next year and data this year, I think is islatravir plus lenacapavir. I think what we have communicated is critical to successful regimens that are robust in HIV is having an integrase inhibitor at the core. Today, about 85% of people globally are on an integrase inhibitor-based regimen. Certainly where we've got two drug regimens such as Dovato, having an integrase at the core I think is pretty critical. I think it will be interesting to see the data, I think for me, when you get to really outstanding weekly orals, it will be with an integrase at the core. Of course there are, you know, let's see where we are with islatravir.
Obviously, we've had, we've seen challenges with islatravir at higher doses in terms of depletion of CD4 counts. I think physicians have questions about longer term, will that manifest itself even at a lower dose if somebody's on this medicine for a long time? However, undoubtedly there will be some uptake, and all the research that we've done says that the weekly orals cannibalizes the daily orals. Actually, our research shows that it doesn't impact long-acting injectables because that is a very specific patient segment, where you've got people who struggle to adhere, who really feel very stigmatized by taking a tablet every day or are really worried about people discovering their status, as well as obviously the benefit of, you know, directly observed therapy.
I think the long-acting injectable segment won't be impacted by the once-weekly, but the daily orals are most likely to be.
Great. Thanks, Rajan.
Next question comes from Sachin Jain. Sachin, please go ahead.
Hi, Sachin, you might be on mute.
Yeah, we're just trying to unmute Sachin. I think you dialed in via phone.
Sorry about that.
Great.
I hope you can hear me now. 2 quick questions please.
Yeah. Yeah.
One on camlipixant. I'm sure you're expecting this, level of excitement headed into CALM-2 with CALM-1 in-house, I guess. Secondly, on HIV, one of your key narratives obviously, Luke and the R&D team, is acceleration of key assets. Given the importance of long-acting injectables, just wondering if there's any scope to shorten or skip the phase II work around Q6M combos and accelerate phase III such that launches are ahead of, I guess a 2030-2031 timeline. Thank you.
Sure, Sachin. I think you get a pass on two questions. I don't think you'd asked a question last time. Deborah, super quick on acceleration options, and then Tony on camlipixant, please.
Sachin, we are looking to accelerate through execution, the delivery of our Q6M or twice-yearly, in treatment and in PrEP. The FDA will not allow us or anybody else actually to skip the phase II part of the development journey. We have to demonstrate the level of efficacy, safety, as well as the kind of appropriate partner for our Q6M. We'll go through the journey of development to demonstrate all of that, but we're in dialogue with the FDA, and there's no way we can skip the phase II.
Thanks, Deborah. Tony?
Hi, Sachin. Look, as you'll appreciate, only a small number of people inside GSK have seen the CALM-1 data, and we'll update you all when the CALM-2 data is in house. It's on track. We had last patient, last visit has already occurred, so we're very much on track for publication around the middle of the year, as I've indicated. Perhaps just a reminder for everyone, here again, 15%-20% reduction relative to placebo in phase III at 24 weeks would be seen as significant.
Great. Thanks, Tony. Thanks, Sachin. Next question, please.
Next question comes from Matthew Weston. Matthew, please go ahead.
Hi, Matthew.
Sorry, the unmute box is taking forever to come through. Thanks for taking my question. It's actually a follow-on to Sachin's secret second question. Deborah, in your opening comments, you expect confidence in the long-acting 6 months treatment regime on the market by the end of the decade. Given that we haven't yet achieved 6 months IM dosing for VH184, I have to be honest and say we're struggling to get to that timeline. Sachin asked if you could accelerate it, you said no. Can you walk through the steps for development that gives you the confidence in being there at the end of the decade?
We've got phase II program, which has already started for VH184, because I think what people sometimes think is when we present the data at CROI, that's where we are in the process. We've already started the phase II-A, which is the oral step we need to go through with VH184. We're expecting the VH499 phase II to start in the second half of the year. Basically we would be starting the phase III, which we are in dialogue with regulators over, as well as our full phase II program in 2028. That allows us then to generate the data that will give us an end of decade launch. That's how everything's set out at the moment.
Obviously, you talk to the regulators every step of the way as you design your clinical trials, you agree the endpoints, and then you move on to the next stage. As we stand here today, the dialogue that we have had with the regulators, the phase II program that we are in the process of agreeing, and our proposed phase III would lead us to an end of 2030 approval.
Thanks, Matthew. Thanks, Deborah. Next question.
Next question comes from Peter Verdult. Peter, please go ahead.
Yeah. Can you hear me?
Yeah, we can.
Yeah. Sorry, guys.
Peter-
Pete here from BNP. Yeah, sorry, guys. Pete here from BNP. Just 1 question, just to follow up on Beppy ahead of EASL. In fact, there's a massive disconnect between your ambitions in terms of commercial ambitions for the product, and I think consensus, which has only had a, GBP 200 million baked in. I realize we cannot go into any B-Well details, but I would like to understand how GSK thinks about getting surface antigen testing, you know, part and parcel of standard practice. KL feedback tells us this is rarely done presently. In terms of, you know, the checks that we've done with the community, you know, they seem to be pointing to a sort of functional cure rate near to 25% for, you know, the infusion across the community to be really high.
I know it could be stat sig anywhere between 15-20. Anything you're willing to say on testing and, you know, what is clinically meaningful from the docs you speak to as we await the EASL data?
Sure. No worries, Peter. I think, very fair questions. I mean, you know, structurally, we've seen this in multiple disease areas. If there's no solution, there's no point looking for the problem. Many of these patients, if you look at the U.S. diagnosis rates, you know, a prevalence of 1.2, I said before, only 500,000 are diagnosed. In Europe, it's a similar ratio. Japan's probably the best of all of them. Our expectation is, and the feedback that we've got is that once you've got an accessible treatment option, because the downstream consequences of this infection are deeply unpleasant, for the individual and the healthcare system, we expect that testing to increase.
Nina, I don't know if you wanted to add any of the work that you guys have done to assess this or any other insights.
Yeah. Peter, I'm not surprised. You know, this is a new, in a way, new approach in treatment of hepatitis B. A lot of these things are obviously very known to us as barriers like antigen surface testing, like diagnosis. We are going into that very with eyes wide open, aware of that. What is very obvious is that there are reasons why people are want to be treated. It's a reduction of hepatocellular carcinoma, first thing. The other one, just stigma of hepatitis B, and that comes with available options for treatment that are lifelong. Patients or physicians are not very keen on lifelong treatment. That's a big motivator to change. Testing will is available.
It's just not used because it doesn't help with anything. It doesn't guide current treatment. It's not, it's not required for initiation of treatment. As soon as there are options that are requiring testing, we believe that is going to increase. Just the last one, I think we need to remind ourselves, reduction of DNA at the moment is the standard which is followed in practice. For patients who have reduced DNA who have also reduced antigen level expression, their risk of hepatocellular carcinoma is dropping by over 70%, close to 80%. It's a very significant driver of medical value and benefit, and that's what we see in the initial conversations with the regulators.
As you can see, you know, we have SAKIGAKE designation in Japan, we have breakthrough designation in the U.S. It is very much recognized by the healthcare authorities. We are going into this into what is new way of treating this disease, and I think you need to allow us also certain level of, well, uncertainty how this is, how quickly this is going to be realized, but definitely the value of the drug is very clearly recognized.
Just a reminder on functional cure rates, 'cause as Nina mentioned, the current broadly used approach is nucleoside and nucleotide therapy, for which the combination of DNA and surface antigen reduction for functional cure is less than 2% for a lifelong therapy.
Yeah. Yeah. If you look at pegylated interferon, Peter, as you know, I mean it's 12 months of treatment and flu-like symptoms for, you know, between 2%-4% resolution. You know, in China, experts would state it slightly higher, you know, heavy burden on the patient. As Nina said, we're being very thoughtful about this, and, but there's a high commitment to this asset, and I think we've got something that will get experts' attention at ease. Let's see. Next question please.
Super helpful. Thank you.
Next question.
Thanks, Peter.
Thanks, Peter. Next question comes from James Gordon. James, please go ahead.
Hello, James Gordon for Barclays. Thanks a lot for taking the question. The question was about Extensa. The early launch progress, I know it's early, and whether you are seeing any switching from existing more frequent IL-5s. I know there's the NIMBLE Extensa switch trial that showed Extensa was inferior to Nucala. Does that mean it's harder to get switches, or are you still seeing some people do a switch? What do you think this launch will look like once you get the J-code? I can see how that could hold it back a bit, but then once you've got the J-code, would it still be quite slow and steady because you're only then really going for the incident, not like the people already on biologics if you're not switching.
If I could squeeze in a follow-up, 'cause I feel that people did. Just on camlipixant, I heard the comment on 15%-20% benefit of phase III being significant, but I think the phase II was about twice as good as that. Why would it be so much lower? Isn't 15%-20% pretty similar to what Merck had with their P2X3, but ultimately I know there's some differences, but ultimately that wasn't approved by the FDA with about a 15%-20% benefit.
Sure. James, I'll answer the second question super quickly. I think the key thing is duration of effect and also the placebo adjusted. That's the operative term. The element with Merck's product really was the off target effect. In fact, it's a much more promiscuously binding molecule in terms of addressing the receptors of P2X3, which are present in the taste buds, and so you get this taste dysgeusia, which unblinded the product and also limited their dose selection. You had, you know, higher disturbance toxicity and lower efficacy, plus some regulatory issues around cough monitoring. I think we're talking apples and pears there, but we've taken those lessons and integrated them into not only the assessment but the clinical program, and we're looking forward to getting those results.
Tony, do you want to go through NIMBLE, Nina then go through where we are commercially with the launch, and then I'm happy to add anything else.
Yeah. Let me just first of all, a little bit about NIMBLE and its design. It was a non-registrational study, not a filing requirement. What's important to understand about the population in NIMBLE is they were very well controlled, the general exacerbation rate was low. It was not designed to make comparisons across switch in the various arms. In fact, if I allow that comparison to be made, Sorry, the difference in exacerbation rates was 0.08 per year. If that implies that a patient on therapy would need 12 and a half years to realize a single additional exacerbation. You put that into the context of the benefit for compliance that's associated with the longer acting agent.
As Nina answered earlier, I think you have the importance of depemokimab as a long-acting agent in that population. I won't go any further on that, but the study was not designed to draw the conclusion that you have, James.
Yeah. Thanks. Tony, Nina?
Yeah, just to add, at the moment the number of patients that are initiating, actually about 70% of them are coming from other biologics. In terms of the question, and obviously we would want majority of the patients to be bio-naive. Just your question about, you know, are we looking at just the incidents. Remember only about 30% of patients are on biologic. There is actually way more patients who are bio-naive than those who are bio-exposed. There is significant pool of patients who are available. In terms of access and J-code, this is a therapy area where J-code is very relevant. It is going to unlock vast majority of the market.
At the moment only about 20% of the commercial patients in the U.S. have access. This is very normal in this therapy area. J-code is really a significant barrier initially. Then, it opens the opportunity as the J-code becomes available.
Yeah. James, I'll just add some other market research, which I think is quite encouraging. If you look at who's prescribing at this point, about 57% of the patients prescribed by pulmonologists, about 23% by allergists, which is in line with what we expected. Unaided awareness is ahead of benchmarks. Intent to use is, you know, nicely at benchmark, and the main driver is questions around access, which is what we expect, particularly when you're buying a 6-monthly treatment. We've got that approach, but obviously the ungaining factor is the J-code. Actually if you look at the T two, you know, faith and belief in terms of sustained suppression of the key T two drivers, this is beyond other biologics at this point.
You know, we're quietly assembling the pieces which will drive usage of this product. Very similar to Blenrep, I think we need to wait until we're into the second quarter before we can give you the full picture. We've just started launch in Japan. I was there the other day. Very good traction. Germany. I was also there the other day. They've got good traction and good start already. I would say we just need to keep watching this space and stay focused. Thanks, James.
Next question comes from Sarita Kapila. Sarita, please go ahead.
Hey, thanks for taking my question. Recently there was a change to the Florida ADAP, Biktarvy access was removed and Descovy was restricted. How should we think about this change and the broader signals for HIV reimbursement in the U.S.? Is there any risk that we see similar changes elsewhere? Thank you.
Thanks, Sarita. Deborah?
Yeah. Thanks for the question, Sarita. ADAP is the safety net program for people who are living with HIV who do not have insurance, and because states are strapped for cash, they are looking at ways to save money on ADAP. What Florida did was 2 things. They reduced the threshold by which you were able to access ADAP, and they restricted Biktarvy and Descovy. There was a court case brought immediately by the community around the threshold at which you can enter ADAP, and they won. It went back to being 400% of the poverty threshold versus 150. That was reversed. There is the opportunity, and there always has been actually to sort of tighten the formulary and that is currently taking place in Florida.
We've seen people switching off Descovy and Biktarvy onto other medicines, you know, obviously, Dovato and Cabenuva as well. I think this is an area of focus as it has been for a while. I think the court case that was brought immediately by the community was very helpful because the threshold of when you can benefit from ADAP was not successfully reduced. I think we should expect other states to look at ADAP and to make sure that it's being run efficiently and effectively. Overall, I don't think you're gonna see a reduction. I think what you might see is some changes to formulary, but as we know, it's very guideline driven therapy area. The community are now pushing back at the restriction of Descovy and Biktarvy.
That may in its own right end up being reversed. At the moment, that is still in place.
Thanks, Sarita. Thanks, Deborah. Next question, please.
Next question comes from Michael Leuchten. Michael.
Hey, Michael.
Please go ahead.
Thank you. If I could please just go back to the Q2 business update. Just trying to understand, is this meant to be a comprehensive review, both top line and bottom line trajectory, or is it meant to be a portfolio update around the pipeline, including ViiV, please?
Thanks, Michael. The latter. I mean, we've found in the past when we do meet the management events as standalone, they're useful to get granularity. The portfolio is becoming broad enough and complex enough, we thought it would be helpful, for you and, shareholders for us to step you through why we're so enthusiastic and what we've been doing with our time over the last few months in terms of accelerating these assets. That's the intent, and to give, yeah, just greater granularity, more depth on the data. Thanks, Michael.
Thank you.
Next question comes from Simon Baker. Simon, please go ahead.
Thanks so much for taking my question. A slightly broader one. Just going back to one of your opening comments, Luke. You talked about accelerating pipeline delivery. I wonder if you could just sort of dig down and give us a little bit more color on that. Is that about changing decision-making processes now, or is it about changing development practice and trial design going forward? Just some color on what that phrase means in reality would be great. Thank you.
Yep, sure, Simon. I always make damn sure I attach any statement to something that we're actually doing in practice, so be sure of that. What does that look like? Every 2 weeks, Tony, Nina, and myself, Mondher, and Deborah, if it's HIV with David, we look through all the clinical execution, look at what studies are on track, which are not, and then it may trigger a discussion around the protocol design, the execution on the ground. The meeting then may pivot to some life cycle opportunities that we've got, if Julie's found some money under the bed, that we can accelerate those programs and the economic justification and the clinical justification for doing that.
You know, very dynamically managing the portfolio, but again, we're not sort of writing emails to each other and, you know, 10 layers of management. It's us interacting directly with the team leaders who are managing those programs and looking them in the eyes, and they get to look us in the eyes about what, you know, where the program's at, what's going right, what's not going right, and how do we fix it. If there's an opportunity, how do we exploit that, without having to sort of have earnestly, you know, endless meetings to discuss that. You know, out of that, we're creating a more aggressive culture.
opportunities, but also one that people have to back up, in what they're doing with the facts or at least a logical explanation scientifically, clinically why that may be a good decision to make. Then we want to gauge the level of risk we're taking. It's, it's really everything that you're saying. The core focus is, you know, I strongly, and, you know, and you guys know this better than me, I strongly believe the way that we're going to create value is to accelerate what we have, in the late-stage portfolio and get it to patients faster in a more broad fashion if there are opportunities for life cycle management, and then translate that into faster top line growth and commercial success. If we do that, we should be creating value for our shareholders.
That's how it works. We also have other ways, again, to redirect resources, and if we see something, you know, not working, we either fix it or take the resources away and give them to someone else. It's a Darwinian process, and it's designed to transparently create value. Hope that helps.
Perfect. Thank you.
Thanks, Simon.
Next question comes from Steve Scala. Steve, please go ahead.
Hi, Steve.
Thank you so much. A question on Shingrix with three brief parts. First, can you quantify the magnitude of U.S. inventory stocking? Second, are things improving in China? Thirdly, it seems like you're all in on dementia, starting a 34,000 patient trial after being cautious for a long time. Is that how to read it? Thank you.
Great. Thanks, Steve. I'll answer the inventory one pretty quickly. Then maybe Nina, if you wanted to cover China. I mean, if you look at the U.S., the IZ rate now is around 45%, that's up 3.5 points versus same time last year, which is in the range that we gave you of 2-4 patient points, you know, each year. If you look at the remaining effort, there's about 70 million people above 50 who remain unvaccinated. About a third of them have intent to get vaccinated. That's material, based on the market research. Again, you know, we're concentrating on the comorbid subpopulation that are more motivated, and their doctors and pharmacists are more motivated to do that. All the market research on pharmacists and doctors are stable.
In Q1, actually, Shingrix was the number 1 priority for pharmacists to vaccinate, which is same as last year before we get to the flu season. In terms of stocking, we did launch the PFS, the fully liquid in 26. It's easier for pharmacists. We don't factor any demand increase because of that, but it's just easier for the pharmacist to employ it. The wholesalers were pretty steady. Q1, 26.6 million doses. If you look at the end of last year, it was 0.5. If you look at the same time last year, it was 0.4. Very much in the typical range. There is some increase in retail inventory associated with the PFS. It was 2.4. If you look at the same time last year, it was 1.7 million doses.
At the end of 2025, which is not necessarily a fair comparator of the flu season, 1.4. Stocking has a component there, but we're also seeing, you know, reasonable underlying demand following the strategy of focusing on comorbid. Nina, anything you wanted to add on U.S. or China, and then we'll go to Tony.
Yeah. Just briefly on China, the number of doses administered to patients is increasing, so that's the demand is improving. You will not see that in the sales numbers because that's going out from the available stock at Zhifei probably for this year, at least majority of this year. We would not see sales numbers changing on the GSK side as that stock is being reduced.
Yep. Thanks, Nina. Work in progress very much in China. Tony.
Steve, on frontotemporal dementia, I would say this is just the latest in the plan we described that sits alongside the study that we have running in the U.K. and now, a pragmatic study in Finland. To give you some details, this is dementia diagnosis and as you said, around 30,000 individuals. It's a Shingrix versus placebo study, and the data capture is largely passes through a registry basis. On a 3-year follow-up. I would look at it very much as just the next example in what will become a collection of studies that explore outcomes with Shingrix in both dementia and indeed these outcomes that I'm doing in partnership with Mondher and the Metafer team.
Yeah. I would stress that maze component, Steve. Great. Thanks for your question. Next question, please, Massimo.
Yeah. We have time for two more short questions, please. Emmanuel Papadakis. Emmanuel, please go ahead. You're next.
Thank you, sir. Yeah. I'm tempted to ask Julie about the money under the bed, but I'll take one on Jemperli. Maybe you could talk a little bit about the softer Q1 relative to expectations after a pretty strong run of results. Particularly interested in how endometrial and rectal outlook is shaping up. I mean, you do have AZUR-1 and AZUR-2 pending, but they're in the MSI-H setting, and you already have a tumor-agnostic MSI-H label. I would imagine they're going to have pretty limited impact. Is it going to be JADE in head and neck that really catalyze the next step up? What's the sort of quantum of commercial opportunity there? Thank you.
Great. Thanks, Emmanuel. Nina, you want to cover?
Yeah. Look, I think we have, we have talked about this before. Of the 2 billion that we have communicated externally for Jemperli, endometrial cancer is about 1 billion, colorectal and head and neck is we see it as another 1 billion. At the moment, we are on track for that. AZUR-1 is going to read out later this year. Very high belief and confidence that that's a positive study as we have seen already. AZUR-2 obviously significantly higher opportunity in head and neck definitely.
Yeah, no, Manuel, we've still got a lot to do operationally in the U.S. in terms of endometrial. If you look at the stats, about 60% of oncologists just use Keytruda despite the overall survival. We've got plenty of area to target those individuals. We do have their market research, so if a physician can recite the survival benefit, they're a lot more likely obviously to use Jemperli. Again, we remain very committed to this product, and look forward to updating you as we get those readouts.
Just to complete the picture as well, we have the chemo-free study in EC, which will have data this year as well. That's looking to expand the population there too.
Great. Thanks, Tony. Last question, correct?
Exactly. Last question comes from Seamus. Seamus, please go ahead.
Hi, Seamus.
Hi, everybody. Thanks for the question. You know, just quickly wanted to get a sense on Nucala and the uptake there. You know, where are you seeing the emergence of, you know, sort of broader utilization? You know, how do you feel that actually positions Exdensur over time in that opportunity? Thanks so much.
No worries. Thanks, Seamus. If you look at the growth of Nucala in the U.S., 50% of that volume is from COPD. Globally, it's about a third. You've got EGPA, HS and other indications for Nucala more broadly. As we launch Exdensur, we take the resources off Nucala, excluding COPD. We have a team in the U.S. who's still promoting COPD and doing quite well, as you can see. All of the other indications are no longer promoted. We're 100% committed to Exdensur. That's the strategy. You know, I would just come back to the relative volatility of these patient populations, which I think surprises everyone and creates a degree of churn that we're looking to exploit with Exdensur. Great. I'll stop there.
Hopefully I answered your question, Seamus. If I didn't, I'm happy to follow up offline. Thanks everyone. Appreciate your interest in the company and hope the questions and answer session was useful. Thank you.