speaker
Nick
Moderator

Hello everyone, welcome to today's call and webcast. The presentation was sent to our distribution list by email and you can find it on gsk.com. Please turn to slide two. This is the usual safe harbour statements. We'll comment on our performance using constant exchange rates or CR unless stated otherwise. As a reminder, adjusted results are now referred to as core like many European pharmaceutical peers. Please turn to slide three. Today's call will last approximately one hour with the presentation taking around 25 minutes and the remaining time for your questions. Today our speakers are Emma Walmsley, Luke Miles, Deborah Waterhouse and Julie Brown. With Tony Ward and David Redfern joining for Q&A. Please ask one to two questions so that everyone has the chance to participate. Turning to slide four, I will now hand the call over to Emma.

speaker
Emma Walmsley
Chief Executive Officer

Thanks Nick and welcome to everybody joining us today. I'm delighted to be presenting to you all with another set of excellent quarterly results for GSK. Please turn to the next slide. We have had a very strong start to the year. Sales and profits grew double digits for the quarter with sales up 13% to 7.4 billion pounds, core operating profits up 35% to 2.4 billion pounds and core earnings per share up 37% to 43.1 pence, all excluding COVID solutions. This excellent performance reflects our continued focus on execution, some benefit from phasing in the quarter and strong delivery of our recent launches. It also demonstrates the great momentum we continue to see across the business. Demand for our innovative vaccines and specialty medicines was clear with strong growth across new products. Our very good sales performance was also underpinned by good cost control. Julie will take you through the details on this in a moment but I particularly want to highlight our SG&A performance which was delivered alongside increasing investment in R&D, demonstrating continued delivery of effective operating leverage and margin improvement. These benefits are also delivering improved cashflow, providing funds for investment and returns to shareholders. Our dividend for the quarter was 15 pence. And for the full year, we are upgrading our guidance and looking forward to delivering another year of meaningful growth for shareholders. Next slide, please. Alongside our excellent financial performance, we've seen strong pipeline progress across the therapy areas with phase three data readouts for four medicines. For Jeopardycin, further pivotal data that supports regulatory submission of this new antibiotic. For Cabanuvra, further evidence of superior efficacy. For Gemperle, potential broader use of this medicine to treat endometrial cancer. And lastly, encouraging clinical data supporting use of Blenret for the treatment of multiple myeloma. These data will be presented at ASCO and we look forward to sharing more with you on our plans for oncology at our meet the management event in June. These readouts together with other R&D achievements this quarter mean we've strengthened growth prospects in all of our key therapeutic areas. Three material points I'd highlight. First, we continue to strengthen our innovative vaccine portfolio this quarter. With regulatory submission of our new five in one meningococcal vaccine candidate, alongside new expansion opportunities for both ArexV in the US and Shingrix in China. Second, positive clinical trial findings for an ultra long acting formulation of Cabotegravir, further supporting progression of this medicine and confidence in the important transition we expect in our HIV portfolio for long-term growth. And third, in respiratory, we completed the acquisition of Aeolus Bio, a signal of our continued investment and leadership in this disease area where our next important step will be sharing data for Depimocomap, which we expect in Q2. Next slide please. Alongside delivering stronger shareholder returns, we continue to build trust by delivering across the six key areas we prioritise for ESG. This quarter we published our ESG performance report. 95% of the metrics we target are being met or exceeded. We also saw the GSK developed TB vaccine candidate enter phase three, sponsored by the Gates MRI and Wellcome Foundation. This could potentially be the first new TB vaccine in over a hundred years. So all in a very good start to the year. Let's now hear more from the team on our progress, starting with Luke.

speaker
Luke Miles
Chief Financial Officer

Thanks Emma, please turn to the next slide. In Q1, we delivered growth across all our product areas and regions with 7.4 billion of sales, up 13% versus last year, excluding COVID solutions. This includes a strong performance in the US, led by continued contributions from our new launch products. Please turn to slide 10. In vaccines, we saw strong growth of 22% in Q1, excluding COVID solutions, led by OREXF and Shingrix. Following the outstanding launch last year, OREXF continued to deliver with sales of 182 million pounds in the quarter. Script data shows a strong preference for OREXF as we received two out of every three retail prescriptions, with US market penetration of around 14%. I'll cover OREXF in more detail on the next slide. Shingrix delivered a record of 945 million pounds in the quarter and was up 18%, driven by public funding outside the US, together with early supply to our new partner, Xifei in China. Outside the US, Shingrix has launched in 39 markets and the majority have less than 5% penetration. In the US, sales decreased by 4%, reflecting the comparison to Q1-23, which benefited from the removal of the co-pay for adults aged 65 and over on Medicare, as well as the prioritisation of other adult vaccines during the bio-respiratory season. We are investing in DTC and ACP campaigns as we seek to activate -to-reach consumers to continue to grow the cumulative immunisation rate, now at 37% of people aged 50 and older, which leaves more than 75 million Americans still unvaccinated and eligible to receive Shingrix. Our expectation continues to be that Shingrix sales will reach more than 4 billion pounds over time, driven by growth outside the US. In addition, we have also recently shared exceptional data demonstrating vaccine efficacy of 82% at year 11. Turning to our meningitis portfolio, Bexera and Menvo sales were up 3% and 41%, respectively in the quarter, with performance in Brazil and favourable phasing driving the growth in Menveo. We're pleased to have received FDA file acceptance for our MenABCWY vaccine in mid-April, and combined, our meningitis portfolio is expected to deliver around 2 billion pounds in peak year sales. Across our vaccine portfolio, we expect sales to increase high single to low double-digit percent in 2024. Next slide, please. Focusing on RSV, we vaccinated over 1.3 million people with Ravexvi in the retail setting during Q1. The launch was exceptional and exceeded our expectations. We now see seasonality similar to flu, impacting use patterns in the first year. In 2024, we expect the vast majority of sales to be in the US, and weighted to the second half in preparation for the 2024-2025 RSV season. This year, we continue to build on our competitive profile with the potential to expand the label, adding at-risk individuals in the 50-59 cohort, which could impact approximately 15 million people in the US. This is subject to approval, followed by ASIP review in June. Last year, we presented data supporting an efficacy profile for Ravexvi of at least two seasons. As the 23-24 RSV season is coming to an end, later this year, we expect to have additional efficacy data on long-term duration of protection and immunogenicity data over three years. We plan to present the totality of data at a future public health forum in the second half of this year, and we do not expect public health officials to decide on the frequency of RSV vaccination or revaccination before 2025. We're ambitious about growth in an expanding market with increasing competition. Whether a two-season or a three-season vaccine profile, we remain very confident that OREXI can achieve more than 3 billion in PQS sales over time. Next slide, please. In specialty medicines, including HIV, which Deborah will cover shortly, we increased sales by 19% excluding COVID solutions. In respiratory and immunology, our market-leading medicines, Nucarla and Benelist are continuing to deliver good growth. Nucarla was up 13% reflecting high patient demand for treatments addressing severe eosinophilic asthma, chronic rhinocytosis with nasal polyps, and EGPA. Our Matinee trial to confirm the efficacy of Nucarla in COPD is expected to read out in the second half of this year. We also expect pivotal trial results for our six-monthly IL-5 Depamocomap. This year with readouts in aspirin Q2 and chronic rhinocytosis with nasal polyps before year-end. Combined, we anticipate our IL-5 portfolio to deliver more than 4 billion pounds in PQS sales. Benelist continues to show consistent growth and was up 8% in the quarter with opportunities to drive earlier intervention and increase penetration in both SLE and lupus nephritis. In oncology, sales more than doubled in the quarter. Omgara has continued to perform well following last year's launch, and I'll talk more about this on the next slide. We're pleased to receive authorization from the European Commission for Omgara in late January, and we've since launched in the UK and Germany. GenPirle has also continued to grow strongly, and again, I'll discuss this further on the next slide. Zidula's performance was driven by increased patient demand and higher volumes due to the new tablet formulation with further growth from new international launches. Overall, we expect strong performance for our specialty medicines in 2024 with growth of low double-digit percent. Please turn to slide 13. Omgara, which we acquired from Sierra Oncology, has performed exceptionally well following last year's launch and has the strongest uptake curve for a JAK inhibitor in myeloproporosis. Omgara is establishing market share in both the first-line and second-line settings, and we've seen encouraging data suggesting physicians are anticipating increasing their use of Omgara in the coming months. For GenPirle, we've demonstrated strong execution in the quarter with our new patient share up 33%, and we continue to build further clinical evidence in endometrial cancer, where we recently presented data demonstrating that GenPirle plus chemotherapy is the only IO combination to show statistically significant and clinically meaningful OS data in the all-comers population. Subsequently, the FDA has granted a priority review to our file to expand the treatment with GenPirle to all adult patients with primary, advanced, or recurring endometrial cancer. We also expect this data to be published soon in a peer-reviewed journal. On BlendRep, we're encouraged by the data from DREAM7, which showed a tripling of progression-free survival. DREAM8 also met its primary endpoint and showed a statistically significant and clinically meaningful PFS compared to standard of care in second-line multiple myeloma. In addition, DREAM7 and 8 also demonstrated strong overall survival trends, and we will continue to follow up to completion. We look forward to presenting these data at ASCO in June and are targeting regulatory filings in the second half of the year. Next slide, please. Finally, turning to our general medicines portfolio, we're looking at the impact of the COVID-19 pandemic The US sales grew 1% in the quarter, led by Trilogy delivering 591 million pounds and established products in emerging markets. We've also seen growth owing to stockpiling and patient demand, and it's still early in the year, and we are continuing to assess and manage the impact of the AmCap removal in the US. And as a reminder, there was 150 million US dollar impact in 2023, and we continue to expect up to 550 million US dollars of sales at risk for the full year. The growth outlook for GenMeds is unchanged. I'll now hand over to Deborah to cover HIV.

speaker
Deborah Waterhouse
Head of HIV Business

Thank you, Luke. We continue to drive HIV market transformation and are pleased to see our growth momentum continuing with HIV sales growing 14% to 1.6 billion pounds in the first quarter. This is driven mainly by increased patient demand for our oral two-drug and long-acting injectable regimens and represents an increase of more than two percentage points in global market share versus Q1 2023. This continued strong performance demonstrates our leadership in transforming the HIV marketplace and delivering on individual patient needs. Looking across our portfolio, Devato, our leading oral two-drug regimen and number one selling HIV medicine, grew sales by 27% versus Q1 2023. Our long-acting portfolio is also showing strong momentum with Cabanua growing 73% and Apertude growing over 100%. With more than 60,000 patients benefiting from these medicines, our ongoing growth is underpinned by strong patient demand and excellent operational execution. We believe that long-acting options have the potential to change the trajectory of the HIV epidemic and as the leaders in driving this market shift, it is positive to see this portfolio grow more than 80% versus Q1 2023 and contributing 17% of total portfolio sales. In absolute terms, this resulted in 116 million pounds of growth representing more than 50% of the total HIV CER growth. Overall, Q1 has been a very strong quarter and puts us firmly on track to deliver a growth rate of high single to low double digits in 2024. We were also pleased by the positive reaction from the scientific and medical community to the comprehensive set of early phase as well as phase 3B4 and real world evidence data that was presented at CROI in March, demonstrating confidence in our current portfolio and progress towards our pipeline of ultra long-acting regimens. HIV physicians and healthcare providers reinforced to us time and time again that the long-acting regimens which they have in their hands today are really transforming the lives of people living with HIV, liberating people from the daily burden of oral therapy, improving adherence and tackling stigma which remains stubbornly pervasive. Data from over 11,000 patients participating in long-acting clinical and real world evidence trials clearly demonstrates the effectiveness of our long-acting treatment regimen. We were particularly pleased with the interim data from the latitude study indicating that Cabinuvra has superior efficacy compared to daily oral therapy in individuals living with HIV who have adherence challenges. We also presented positive phase one data from a study of Cabotegravir, ultra long-acting, dosed at intervals of at least every four months and positive phase two A data from the Banner study exploring the use of our novel broadly neutralizing antibody N6LS for the treatment of people living with HIV. These data show continued progress towards our ambition to end the HIV epidemic, delivering our ultra long-acting pipeline with Cabotegravir replacing Dolotegravir as our foundational medicine. We remain on track to offer four monthly dosing options for prevention in 2026 and treatments in 2027 as well as extending the dosing interval of our long-acting regimens in treatment and prevention to enable every six months dosing towards the end of the decade. At our September, 2023 Meet the Management event, we committed to delivering around 40% of our revenue from long-acting medicines by 2027 and our current performance puts us on the right trajectory to achieve that goal. We are therefore confident in our ability to navigate through the revenue impact associated with the loss of exclusivity of Dolotegravir. With that, I will hand to Julie.

speaker
Julie Brown
Head of Finance

Thank you, Deborah and good morning, everyone. As a reminder, to align with European pharmaceutical peers, we've changed our naming convention to be referring to core instead of adjusted results. Next slide, please. Starting with the income statement, with growth rates stated at constant exchange rates. Sales increased 13%, excluding COVID solutions and we're up 10% overall, reflecting continued strong business performance. As Luke mentioned, growth benefited from newly launched products, Erexy, Adyara and Jim Purley, along with earlier than expected, Shingrix sales to our partners, Yifei and China. Together these added five percentage points of growth in Q1. Core operating profit grew 35% excluding COVID and 27% overall, and the margin increased to .2% with leverage from gross margin and SG&A. Cost of goods benefited from mixed effects, including growth of higher margin Erexy, Shingrix and specialty care products. We expect to deliver gross margin leverage in the full year with benefits predominantly in the first half, given anticipated sales phasing and mixed dynamics. At the full year, we discussed our focus on delivering improved operational leverage as we seek to benefit from the investment made over recent years. Against this backdrop, we please 2024 has started well with underlying low single digit percentage SG&A growth. This together with a one-off benefit from the successful Jujula royalty dispute caused SG&A spent to decrease in the quarter by 2%. R&D investment continues to grow broadly in line with sales as expected, mainly within our vaccines, respiratory and infectious diseases late stage portfolios. Core earnings per share grew 37% in the last year, including the high food and COVID solutions. Now turning to the total results, operating profit decreased 18% to 1.5 billion pounds, primarily reflecting a charge arising from the remeasurement of the Veev CCL and Pfizer put option, largely resulting from improved longer term prospects in our HIV business and currency. Overall, currency was adverse in the quarter due to the strengthening of sterling against the US dollar and emerging market currencies. Next slide, please. Moving to the core operating profit margin. On this slide, we have shared including and excluding COVID to provide a review of our margin dynamics. Excluding COVID, the margin improvement was significant at 580 basis points at CER due to two main reasons. First, underlying margin benefits contributed 410 basis points driven largely by sales growth, favorable product mix and SG&A leverage, partly offset by the impact from the loss of Gardasil royalties. And secondly, the Zizoula royalty dispute contributed 170 basis points of margin improvement in the quarter. Including COVID solutions, there was a 460 basis point improvement driven by similar factors. Next slide, please. Cash generator operations was 1.1 billion pounds representing an improvement of 0.8 of a billion over Q1 last year. This was driven by core operating profit and favorable working capital with the latter benefiting from higher receivable collections particularly in the US vaccines business. Free cash flow was 289 million pounds in the quarter. Relative to an outflow last year and therefore improving year on year by 978 million pounds. Next slide, please. Slide 20 shares our net debt position since the 31st of December last year and how we've actively deployed capital in the business in line with our framework. Net debt was broadly stable compared to the end of 2023 at 15 billion. This included further monetization of our stake in Halion and the completion of the acquisition of IOLOS Bio in the quarter. With our end 2023 net debt to core EBITDA ratio of 1.5 times and expected cash generation, we have a strong balance sheet to support continued investment in future growth including through BD as we look to deploy funds to enhance growth and deliver attractive shareholder returns. Now with that, I'll turn to our full year expectations. Next slide, please. Turning to guidance, there is no change to our sales range of five to 7%. But we're increasingly confident of the full year being towards the upper part of the range. We are upgrading our operating profit guidance to nine to 11% reflecting the strong start to the year and benefits from the Zizoula patent dispute in the first quarter. We also expect royalty income to be slightly higher between 550 and 600 million pounds in 2024. These benefits also flow through to our earnings per share now upgraded to eight to 10% for the year. I also wanted to give some color on anticipated phasing throughout the year starting with sales. Continued execution of the successful launches of Rerex, Fiat, Jara and Jemperly life cycle innovation has contributed five percentage points of growth in Q1 and will continue to benefit Q2. However, we will annualize their launches including the initial channel inventory building Rerex V in the second half. This year is also the start of our agreement with Jifei for Shingrix in China. As Luke said, we had earlier than expected sales in Q1 but still expect the majority of 2024 Shingrix sales to be in Q2. Taking these factors together, we therefore expect sales growth will be significantly higher in half one relative to half two. And turning to the operating profit dynamics, we continue to expect SG&A to increase in the low single digit percentage range and for R&D to increase broadly in line with sales for the year. As a result, driven by the sales phasing, operating profit growth will also be significantly higher in half one given the operating leverage. In summary, whilst it is still early in the year, we've made an excellent start to 2024 and are confident in delivering the full year guidance and longer term outlook. Turning to slide 22. Lastly, our IR roadmap, which shares our progress towards major milestones and value unlock opportunities. It's clear that we've had a very positive start to the year with a number of important pipeline events delivered, as Emma mentioned. The main milestones expected in the next two months are the US FDA approval of a RECSV in adults, age 50 to 59, the phase three data readout of Depimocomab in severe asthma with an Eosinophilic phenotype and the presentation of BlenRep data at ASCO in June. Turning to R&D milestones, many of the successes since Q4 have been within oncology. And we look forward to our Meet the Management event in June to share a deeper review with you. I will now hand back to Emma to conclude. Thanks,

speaker
Emma Walmsley
Chief Executive Officer

Julie. So to summarize, GSK continues to deliver on its commitments and perform to a new standard. Our excellent performance in Q1 provides us with clear momentum. We're pleased to be upgrading guidance and expect to deliver another year of meaningful growth in sales and earnings in 2024, as we continue to focus on prevention and changing the course of disease for millions of people. This all bodes well, but it's still early in the year. And we remain very focused on delivering on our commitments and more at continued pace for patients, for shareholders and for our people. Combining science, technology and talent to get ahead of disease together. With that, I'll now open up the call for the Q&A with the team.

speaker
Nick
Moderator

Thanks, Emma. We're gonna take our first question from Mark Purcell at Morgan Stanley. So Mark, over

speaker
Mark Purcell

to you please.

speaker
Emma Walmsley
Chief Executive Officer

Hi, Mark.

speaker
Mark Purcell

Yeah, good morning, good afternoon, everyone. Thanks for taking my questions, Nick. So two questions. On Shingrix, could you help us understand the contribution we might expect from Zifay in the four year 24, and then going back to your point of ex-US penetration being less than 5% versus steady 17 in the US, could you still like help us understand if there are any leading indicator countries which we could think about in terms of the broader ex-US penetration increasing or other vaccines that could be proxies for how the ex-US penetration could go? And then the second one on the Carlos CAPD, there's been some discussion around Dupixin and a potential delay to the Bidufra and Sanofi Trays label brett for time into the market. Could you help us understand the brettes of the matinee trial in terms of the patient population you're addressing? I think you've got broncholithic and emphysemic patients in there, and it's a broad EOS phenotype as well. So it'd be helpful to understand the relative brettes of your label and target population. Thank you.

speaker
Emma Walmsley
Chief Executive Officer

Great, thanks Mark. So we'll come first to Luke on the prospects of G expansion on Shingrix, and then we'll come to Tony to you once you're ready.

speaker
Luke Miles
Chief Financial Officer

Sure Mark. So I'm pleased to say it's following very much in line with the strategy that we've been outlining over the last few years. So with the contract with GIFE, it's around 400 million pounds with the contract. As we've said before, we are somewhat limited with supply into China this year. So 400 is the number that you should use, and then 800 next year, and then 1.2. The intent of course is to run that relationship significantly beyond the initial three years. Encouraging start, we're now in the field as of April with GIFE and the points of vaccination expansion is very encouraging. So good news there. In terms of analogs, look, I think in markets like Europe and Japan, it's very much about reimbursement penetration. So I think the UK is a good analog. Spain, Italy, these are good analogs, and we're very much at the start of the process in those markets with single digit penetration overall. In terms of emerging markets, I think you've got a range of markets. I think Saudi is quite interested in terms of government support for tenders and things like that. We've been very strict on pricing, so that's encouraging. And then out of pocket markets like Brazil, and again, we're in single digit percentage penetration here. So very early days in those markets at a very tight price corridor.

speaker
Tony Ward
Q&A Participant

Hi Mark, so in theory, even you call it matinees is the study you referred to, it's ongoing and we expect it to read out at the end of the year. To get to your questions, it's a broader population. We've included emphysema as well as chronic bronchitis, phenotypes. That's important because of the 500 million individuals with COPD, about 30% of them present with an emphysema phenotype. We're also excluding any current or prior diagnosis of asthma. That was important given the nature of the CRL for the previous studies. And I think it's worthwhile just pointing you to the data that we disclosed at ATS, which was a post hoc analysis of those previous studies, showing that in that broader population, we see a 24% reduction in exacerbations. It's also important to stress that this is a two year data set in an area in which quality of life is also important over and above headline reduction of exacerbations.

speaker
Emma Walmsley
Chief Executive Officer

Great, thanks Tony. Next question please.

speaker
Nick
Moderator

Okay, we'll take on next question from Kerry Holtz at Barenburg. Kerry over to you please.

speaker
Kerry

Hi there, thank you for taking my questions. On a rec stage, just thinking about underlying demand into the next winter season, when does the contracting process start for the upcoming season? Is that something you're already engaged in? And how might the arrival of a certain investor in Moderna impact that process at the competitive landscape? And then just a quick follow up on Shingrix, can you quantify the exact amount that was booked in Q1 relating to the Zifei agreement in China? Thank you. Thanks, well

speaker
Emma Walmsley
Chief Executive Officer

Luke, I've come to you almost please.

speaker
Luke Miles
Chief Financial Officer

Yeah, sure. So, I mean, underlying demand for EREC, we remain very confident. I mean, if you look at all the market research, whether it's consumer patient awareness, which is around 86%, if you then look at measures of physician and pharmacy, confidence to knowledge and confidence to discuss RSV with patients and potential people for vaccination, it's extremely high, it's in the 90s and high 80s. And that continues to be there. So there's a confidence and insight there behind that. In terms of the, so I think that will ultimately be translated because there's an ideal, obviously synergy with the flu season that we can take advantage. Our overall intent over time, as we've done with Shingrix, is to de-seasonalize that to manage pharmacy workflow. But yeah, good signs there. And of course, if you look at Q1 demand, that was pretty much the same when you look at in-arm shops as we saw in Q3 of 2023. So good sign. In terms of contracting, everyone is very busily doing that, but I don't think anything will be ultimately consolidated until we see the June ACIP outcome, which is linked to the other part of your question, which is the presence of Moderna and the impact there. So if you can imagine you're a pharmacy chain, you wanna see whether A, is there gonna be two or three vaccines? Does anything come up in terms of subgroups, for example, asked with 50-59, further discussion on GBS and other topics. And also, yeah, what's the interpretation of the data that Moderna has? So all these are moving parts. Once we get through that, then I think there'll be a race to lockdown contracts as we go into the season there. In terms of GIFAs split with Q1, we don't break that out for China, but the main thing to remember is if you think about phasing, just via modeling, Q1 is where we get orders. There's nothing in Q2, very limited as we ship. And then Q3, you'll see a bolus, and then very little in Q4. Sorry, Q3, nothing in Q3 and a lot in Q4.

speaker
Emma Walmsley
Chief Executive Officer

Yeah, and just so RSV, I don't think we're gonna see much in Q2. That would be an important point to make because it has stayed seasonal in its first year, although absolutely we'd love to move that over time as we've done very successfully in Shinriks too. Okay, thanks, Luke.

speaker
Luke

Next question, please. Next question, Manu, comes to Graham Parriott, Bank of America. Graham, over to you.

speaker
Graham

Thanks for the questions. So firstly on Shinriks, just if you can help us understand US dynamics. So obviously scripts are down. I know if you just help us understand what was going on in the non-retail segment there, is that stabilized or even growing again now? And on your peak sales guide there, I think it's still just 4 billion by 2026. It looks like you have a fighting chance getting there this year, certainly 25. So just any thoughts on if and when you might update on that, do you need to see your supply issues in China sorted to get more confidence in Ziffa growth above the contracted volumes? And then on EREX fee, could you help us understand where the total penetration rates that you see are now between yourselves and Pfizer in the comorbid and the over 80s population where risk is greatest? As you go into the new season, how many of these people have actually already had a vaccine and are you going to sort of, I guess, a more difficult to reach population now?

speaker
Emma Walmsley
Chief Executive Officer

Okay, well, that's all back to Liv again. I would just say, Graham, that we're not going to update our peak sales forecast for Shingrix, it's more than four over time. Obviously we've just had another record quarter, which is great. And I'm really excited about what's coming for Ziffa. But we, as Luke said, we're contracted for two and a half over the next few years and we're hoping to be more ambitious for that. But Luke, do you want to comment specifically on the Shingrix? Sure,

speaker
Luke Miles
Chief Financial Officer

and Graham, on the supply with China, it's a 2024 effect. There was a slight tweak in the process that the Chinese regulator required. We've done that and now we're shipping. So that's the key thing. We're uncapped in 25 and 26 and hopefully beyond. Okay, so there's some structural things that have occurred here. So the main element, as I said, in the earlier part of the call was Q123, you saw a bolus of people who were waiting for the copay to be removed. And so that was our highest retail TRX quarter with Shingrix. So it's a tough comparator for the TRX retail. Now your question was obviously about non-retail. I mean, if you look at the trends, last year we averaged at about 1.3, 1.4 a quarter in arm shots with Shingrix. Whereas in quarter one was about one. And what is happening is because the administration costs and the paperwork around the copay, we're just seeing a structural shift of positions just saying the patient looks a lot easier if you just go next door to the pharmacy and get your shot there. And so that shift has happened. We have actually recovered some ground in terms of growth, in terms of penetration in the centers beyond the two core ones, the three core ones we had, but we are pushing against this tide, which is just much easier for everyone if they go next door. Now the challenges when they go next door in quarter one, the pharmacists are very clear in terms of the market research, their priority is flu, RSV. So a little bit of a victim of our own success there and COVID. In quarter two, I expect that obviously as we move to the summer months, they're all signaling very strongly that they expect to move Shingrix up. And we've actually seen that in terms of stocking levels in pharmacies. Wholesaler levels are stable, but we've seen the pharmacists start to build the stock up. So when we see that, there's clearly an expectation of a shift to start vaccinating those patients there. So that's encouraging. I think I've covered everything.

speaker
Emma Walmsley
Chief Executive Officer

Yeah, anything you want to say on the RxV penetration?

speaker
Luke Miles
Chief Financial Officer

Yeah, yeah, sorry, yeah. I mean, I think our strategy has been very clear, which has been to concentrate on the comorbid individuals. And we have outstanding market research there showing the intent of pharmacists and doctors to discuss this with patients and vaccinate them. And when you look at the number one reason someone recommends RxV, it's efficacy and it's efficacy in these populations. But we're very much in the early days. But that initial penetration, the bulk of that is those high risk informed individuals that have gone in. I don't have the exact percentages in front of me, but yeah, it's about 80% of those people are comorbid older individuals. So there's 65 plus, where there's a lot less and that's 60 plus. And of course, if we can get the 50 to 59 comorbid, that's a nice growth opportunity for us because they're just as aware of their risk as is their position with these polycomorbid individuals.

speaker
Emma Walmsley
Chief Executive Officer

And that's another 15 million Americans in the at-risk comorbid 50 to 59, which is an exciting prospect. Okay, next question please.

speaker
spk13

We're going to come to UBS and Joe Walton. So Joe, over to you please. Hey, Joe. Joe, I was starting on mute. Apologies.

speaker
Joe

Three quick ones please, or two related. Just to tell us a little bit more about AMP CAP. Trilogy did extremely well. Can you confirm that there's no bleed across in terms of rebates, et cetera, that is going to impact that and that that is continued? Well, I wonder if you could also just all talk about Zantac litigation. We've now had one case that has gone to trials where you have previously been settling and you haven't settled that one. And we now see lots of potential cases and a saga on the set of cases coming out in California. We're just wondering if there's any timeframe or any updates as to when you might be able to resolve this situation.

speaker
Emma Walmsley
Chief Executive Officer

Okay, well, I'll come to you in a second on AMP CAP and rebates off the back of another quarter of absolutely fantastic dynamics for Trilogy. But let me make some comments on Zantac for everybody on the call. I mean, first of all, we remain very confident in our position and continue to defend the science and the facts very vigorously. Obviously, you know that since 2019, there have been 16 independent studies that have been categoric in showing no causal link between renitidine and cancer and the extensive reviews of the FDA and the EMA as well. Now, obviously, Joe and others, you would not expect me to comment on the specifics of our legal strategy and especially with ongoing and current cases, but I do want to also emphasize and remind everyone that the upcoming Daubert hearing is purely a question of admissibility of evidence. Absolutely nothing whatsoever to do with any judgments on liability. And we are very focused on, as I say, defending our position vigorously. And in the meantime, this team and the whole organization is really all about delivering on our operating performance, our momentum for growth and continuing to invest for growth as well in line with our capital allocation priorities. So that's as much comment as I'm going to make on the Zantac today. Luke, would you like to come back to AMCAP and

speaker
Luke Miles
Chief Financial Officer

read it? Yep, thanks so much. John, I mean, Trilogy is really quite separate from AMCAP. I mean, the drivers there are the momentum around the gold guideline changes, commercial execution. We have a very strong team in the US. Very simple messaging there. I mean, we have around 64% of those patients who are on triple therapy with COPD and about 67 with asthma in the US. So very strong penetration there. And you've still got a sizable proportion of individuals who are not responding to treatment. So between 40 and 60% of patients still exacerbate depending on which numbers you look at, which is good for Trilogy and could be very good for NeuKyler and Depamocomab long term. In terms of AMCAP, I mean, the numbers that we've given in the past are still the same. We had the 150 effect at the end of 2023. If you look at broader exposure for the rest of 2024, it's still around 550. I mean, I think to be fair, we did better than we're expecting in quarter one. Some of the strategies that we had commercially did exceed our own expectations, which is always nice for further and the other way around. But there will be a counter move to those. And so I don't think we're gonna see the full effect until we're talking the half year results for the total AMCAP exposure. And then just back on the China question, Nick's just told me it's about 20% for Shingwix sales will be in Q1 and then 60 to 80% in half one for

speaker
Luke

your own phasing of that 400.

speaker
spk13

Next question please.

speaker
Luke

Okay, can we see our next question from Steve Scarlett. So Steve over to you.

speaker
Steve Scarlett

Thank you very much, two questions. GSK has had a strong run of under promising and over delivering. And for that it deserves tremendous credit. So why shouldn't we think about the statement that H1 will be stronger as H2 as more a messaging strategy, not a true reflection of fundamentals, and just assume that H2 will be much stronger than GSK states. I've heard everything you've said, about the business, but the business has great momentum. The total turnover comps don't support your statements. So I guess in the end, the question is, why are you so pessimistic about your own business in H2? The second question is, why is GSK developing an H5N1 pandemic flu mRNA vaccine? Is this a just in case, or are you hearing of significant concern from health and government authorities? Thank you very much.

speaker
Emma Walmsley
Chief Executive Officer

Thanks Steve. Well, I'll come to Tony a bit on the second question. On your first one, just to re-quote Luke, I'd rather it that way around. But listen, we are absolutely, and I'm going to ask Julie actually to comment and reiterate the thinking on phasing. I just want to remind everyone we're at Q1. We're absolutely delighted with the start to the year. And really pleased in terms of the progress, both the growth of vaccines and specialty, but also the earlier Luke's just said, delivery in gen meds as well. And obviously we intend to keep you updated through the year. There are some very real comparison questions, but make no mistake, the whole of this team and all the people that support these teams are very focused on maximizing delivery that we can. Whether it's this year, we're way beyond that. But Julie, do you want to add any more points on

speaker
Julie Brown
Head of Finance

the items? Thank you. And thanks for the comment. I think the main thing is that we definitely know we've got to benefit with phasing in the first half. As we mentioned, we are going to annualize some very strong launches that we did in the second half last year, including EREX, FIA, JARA and GenPirley life cycle indications. So that's definitely a factor. Those alone added five percentage points of growth in our first quarter, just to give you the sense of the numbers. As Luke mentioned, secondly, we've got Jifei in China, fishing grits, which is going to be first half loaded. We're expecting around 60 to 80%. And therefore that also skews the phasing. And then I think the final thing to say is there are two factors, you know, where we're very conscious of one is AMCAP. I think Luke gave a good feel about the AMCAP dynamics. And we're waiting to see how that pans out in the second quarter. And then obviously we're entering the main vaccine season and we believe we've got an expanding market, sure. And as Emma mentioned, we're going to go all out to win, but we've also got a third competitor in the ring that we've got to be conscious of. So that's why we've guided the way we have. Thank you.

speaker
Tony Ward
Q&A Participant

And I'll keep it short on H5M1. It's in response to health authority requests and it's triggered by a change in the transmission associated with that variant very early and very say I'm in a bonus quarter.

speaker
spk13

Next question please.

speaker
Nick
Moderator

Okay, we're going to come to Brett Burn Atlantic and Simon Baker. Simon, over to you please.

speaker
Simon

Thank you, Nick. And good afternoon everyone. Thanks for taking my questions. Tera, if I may please. Firstly on Shingrix, the very strong long-term efficacy data suggests that a general revaccination is still some way away. But I just wonder, are there any specific populations where revaccination might be on the horizon? And then moving on to oncology, the performance in oncology. I just wonder how much is left in the near term, given the strong share, particularly with Jim Purley in endometrial, the strong performance in a jar. I mean, the suggestion is that doctors will be using a lot more of it in the next six months. I just wonder if you could give us an idea of what that near term upside is within oncology in 2024. Thanks so much.

speaker
Emma Walmsley
Chief Executive Officer

Well, oncology has also stopped extremely well. So Luke, perhaps you'd like to comment on that. Still an emerging business for us. But you know, you'll definitely get a lot more at meat and management too. But you want to pick up with that and then Tony, I'll come to you on the shingrix.

speaker
Luke Miles
Chief Financial Officer

Yeah, I mean, I think the short answer is this. There's plenty left to run. If you look at OJARA and the launch, you saw the chart there. Market research, again, is very encouraging. The positioning of the product has been very deliberate in terms of targeting individuals with anemia, which is about 40% of subjects in first line and 70% in second line. If you look at barriers to use, the number one barrier, which is not a major one, I haven't used the product before, which of course we're happy to assist people in doing that. And then the second one is just access and having on the tendons. So that's what we're doing. If you look at early market share, I disclosed those earlier, I think it's quite exciting, 14% and 28% so far. So I think, yeah, very encouraging to keep that. Of course, we're accumulating these pages. They're very long tails once they're on, particularly first line. So we had an initial bolus of patients who are more refractory. And now we're moving into exactly the universe that we expect to see more durable usage in, which is first line individuals with hemoglobin levels below about 10. In terms of Genferly, I mean, Endurimetrial is the focus right now. We'll cover a lot more broadly, I don't want to preempt the meet the management call, but we'll cover more on the life cycle plans for Genferly. There's some pretty interesting, exciting work going there. If you look at the perception versus Pembrolizumab, Pembrolizumab is the easier choice, is more broadly available, people are more familiar with it, but we are seeing quite a striking shift in terms of positions, assessment of Genferly and willingness to try it. And as we mentioned earlier, the fact that we have a very strong hazard ratio of 0.69, and that's coming out of the FDA, hopefully on the 5th of May, if that then means downstream NCCN guideline changes, which you would expect with survival, then that's a further propellant for growth. And then with Zidula, again, shift to tablets, that's more of a one-off effect. But if we can just hold that business pretty stable in the US, which I think we can, following the label changes. And then if you look at ex-US, we've got good growth in Europe, which is heavily volume driven, and emerging markets, we're still in the launch phase with a lot of these smaller markets. So Netnet with oncology, I think we're well placed to keep things moving. And we'll tell you more at Meet the Management around ASCO.

speaker
Tony Ward
Q&A Participant

Yeah, and probably the only thing to add to that, obviously we have a pre-MROPOS data coming for the Zidula soon as well. So, and that will also figure early in the year. Let me address your question on Shingrix, Simon. So, and most of you haven't followed it, the long-term followed data exceptional with nearly 80% efficacy overall in the 50 plus population. Of course, what that does is underscores the value of vaccinating with Shingrix from 50 years onwards. I'd say based on the strength of the data we've got so far, there's no clear evidence as to when a booster will be warranted. But obviously we're continuing to monitor the nature of breakthrough in particular in at-risk

speaker
Luke

populations.

speaker
spk13

Okay, next question, please.

speaker
Luke

So, next question is James

speaker
spk05

Gordon from J.P. Morgan. James, over to you please. Hello, James Gordon, J.P. Morgan. Thanks for taking the questions. First question was about Erexie revaccination and make sure I got Luke's comments correctly. So, was it the two-year dosing interval revaccination data is now gonna be an H2, so maybe an ACIP meeting in October. And this is the 004 study antibody titer data. So, do you now have data that says with the two-year interval, there are much stronger is a much stronger boost on antibody levels. And that's what's giving you the confidence that you'd get the two-year recommendation even though you won't have clinical data. And then the second question was just a couple of one-offs that Luke and Julie mentioned. One was Shingrix US, I believe was down 4%, but there was some pricing and prior inventory moves. So, is that a clean trend or could Shingrix in the US still be down teams for the year? And GenMed looks like it could be a bit of a one-off as well. So, I think it grew 1%, but you're saying down mid single digit. So, the extent to which GenMed has a one-off and then also just gross margin looks very good up to 300 bits, but you're gonna have higher RxV cells in H2. So, can we say the Q1 gross margin and then give a boost from more RxV cells in the second half or is there something one-off there at all?

speaker
Emma Walmsley
Chief Executive Officer

That's at least four or five questions in there. So, anyway, I'm gonna come to Julie first on gross margin. Then, Tony, if you could talk about the two-year, three-year data, just to clarify that, and then Luke will come back to perhaps repeat on the Shingrix and GenMed questions that have been re-raised.

speaker
Julie Brown
Head of Finance

Thank you, thank you, Emma. It is definitely the project mix. So, because we had such a strong half in the second half of last year, largely based on those launches, which is specialty care and vaccines, a high margin, because we had Shingrix, so we had RxV, and we also had the JARA and GenPervin Lifecycle, they significantly changed the gross margin and we'll be up against those in the second half of this year because there were new launches. So, that changes the dynamic in gross margin overall. We also have the shocking effect of course last year. I think that was gross margin done.

speaker
Luke Miles
Chief Financial Officer

Yep, so Tony or me?

speaker
Julie Brown
Head of Finance

You

speaker
Luke Miles
Chief Financial Officer

go first. Yep, okay. Look, I think, I don't wanna repeat myself on Shingrix US. I mean, the key thing is there is a structural shift out of non-retail to retail. We're addressing that. We've also said as you go up that curve of adoption, you have to work harder for those patients and that's what we're doing. But, if you look at it last year, we increased the penetration by 7%. So, if we can keep adding one plus percent each quarter, then it's still big numbers, James. And I think as I said earlier, you'll see pharmacists start to switch on and come back to vaccinating Shingrix instead of the respiratory vaccines as we come out of winter in the Northern Hemisphere. So, I think still lots of reasons to be balanced and certainly not double digit pressure. And then also, again, the strategy has always been with Shingrix, which is to saturate the US and then move into Europe, which again, the extended efficacy data helps us. Which is when we're negotiating with payers that haven't got national tenders like we are right now with France, the fact that you've got this outstanding efficacy at 11 years is really compelling value for money for these governments. So, that's very helpful. And also for individuals paying out of pocket. And then of course, we've mentioned China. So, the strategy that we've had of US, Europe, emerging markets is very much in place. With prices

speaker
Emma Walmsley
Chief Executive Officer

maintained.

speaker
Luke Miles
Chief Financial Officer

Exactly, with very disciplined pricing corridors. And then ultimately, I mean, we mentioned booster, which may only be a subset, but there's also the exciting work that we're looking into with dementia, which again, I think you'd have to rewrite the penetration rates in a few years' time if we did demonstrate a prospective outcome on that one. In terms of general medicines, look, I mean, the way you look at AMPAC is about a 4% drag. So, if you factor that in, I think we're still very much in with the range that we've talked about. We did see an effect of product like augmented a good season in Japan with hay fever. So, these will start to wash out over the year and the more typical structural effects in general medicines will keep there. And the fact is when we get up in the morning, our first priority, of course, are vaccines and specialty care, general medicines, in terms of resources, everything, by definition has to be third on that priority. So, if we can grow in other areas, that's where we're gonna spend time, money and effort.

speaker
Emma Walmsley
Chief Executive Officer

And the super contribution to the mix as we, I mean, we're now at two thirds of the business. This is one of the most important structural shifts in the company and is what is helping to drive leverage for us. Is this move to where innovation can either be truly unique, sustained in an enormous demand because of its direct returns in prevention in vaccines or real breakthroughs in step changes in care and prevention in specialties we're seeing with the pipeline that's coming through. Tony, do you wanna talk about that? Yeah, it's very

speaker
Tony Ward
Q&A Participant

high level. I'll walk you through the considerations for the season three data, James. So, first of all, just to remind you, I think it's a decision that's very unlikely before 25. And that's because the first subjects to receive the commercial vaccine are protected through the 25 seasons. So, whether or not you revaccinate, that can wait until 25, 26 seasons. There are two important data flows running into that. One is the Vaccine Efficacy Study 006. That is dependent on the season and the Northern Hemisphere 23, 24 season has not yet finished. That's a CDC decision. It's a global study and that is what is behind the move of the data into the second half. The second data flow is the immunogenicity study. That's 004. And that is on track to report out in the second half. And it includes a number of different revaccination schedules, I don't wanna get into the detail on that. Save to say that what we're seeing there from earlier data is as is expected, which is the longer you wait between vaccination, the greater the boost.

speaker
Emma Walmsley
Chief Executive Officer

Thanks, Tony. Next question, please.

speaker
Nick
Moderator

Okay, we're gonna come to Emily Fiddle at Barclay. So, Emily, over to you, please.

speaker
Emily Fiddle

Hi, thank you for taking my question off. The first one is, Gilead last week talked about the impact of the part fee redesign on their HIV business resulting in flat growth for 2025. I was just wondering if you could give any color on how you're expecting that to impact your own business in 2025? And then secondly, just on Blend Rep, before it was removed from the peak sales guide, I believe it had been for a guidance of over 3 billion in peak sales and now having Dream 8 and Dream 7, I was awaiting the data from Dream 8. Could you talk about perhaps expecting when you may add that in or characterize how that peak sales opportunity may have changed with the new indications? Thank you.

speaker
Emma Walmsley
Chief Executive Officer

Thanks, Emily. Just on the peak sales from Blend Rep, we're obviously not gonna be updating that today. We're explicitly, it's an interesting reference point to look at 21 when we were talking about earlier lines, but we have new data, exciting data that's come through. We're gonna be presenting at ASCO. Tony, Luke and our teams will update you at the meet and management about how we see the path forward. But we've obviously got a journey to go on with the regulators. We're very engaged in that. But clearly, what we're interested is in the step change of impact for patients and that could be very exciting and we'll keep you updated along that journey in due course. Deborah, excited to have a question on HIV. So perhaps you could comment. We don't guide by asset by year, but we have factored this into our broader outlooks and Deborah, can you give a bit more color to that please?

speaker
Deborah Waterhouse
Head of HIV Business

Thanks, Emily. So the first thing to say is we're obviously delighted by our growth in Q1, which was 14%. And we're particularly delighted because as I said earlier, 50% of our growth, our pounds growth came from long-acting injectables. The momentum behind those medicines is continuing to be extremely important today driving growth and will continue to be important to the end of the decade as our pipeline, which is long-acting injectable orientated continues to make great progress. In terms of 2025, so we believe that the IRA, Medicare Part D redesign will have an impact of about 200 million pounds next year. So it will be a drag, but actually, as you can see, our growth is, our growth and momentum is very strong. So it will have a headwind, but we believe that's manageable and has already been factored into all of the guidance you've given, including our upgrade last year to our five-year CAGA 21 to 26 being a six to 8% growth and more than seven at a group level.

speaker
spk13

Next question, please.

speaker
Nick
Moderator

Thanks Emma. I'm mindful of the fact that we are at the end of the call. So we're gonna run for another 10 minutes. We do have five individuals with hands raised and we've endeavored to get through as many of these as possible. If we can keep both the question and answer concise, then hopefully we'll get there. So Richard Park, I'm gonna come to you please next at the BMP Paribas.

speaker
Richard Park

Hi, thanks for taking my question. I just wanna push a bit more on the RSV revaccination potential. It's my understanding is that you'll no longer have vaccine efficacy data for patients having received a booster before season three. So we're just gonna have immunogenicity data. So I'm just wondering about how confident you are that ACIP will make a recommendation based on just immunogenicity data when the previous booster data we saw showed no additional benefit from booster after season one. So that's the first question. And then second on just on Shingrix just to round off the discussion. So in Europe growth is slow to single digits. I'm just wondering, is that just a capacity allocation or could we expect to see a sort of re acceleration in growth for Shingrix in Europe? Thank you.

speaker
Emma Walmsley
Chief Executive Officer

Okay, quick answers, Tony and then you. So

speaker
Tony Ward
Q&A Participant

ACIP will make a decision this year and it will be on vaccine efficacy from three seasons and immunogenicity when we present those data together. Thanks Luke.

speaker
Luke Miles
Chief Financial Officer

Yeah, it's very much driven as we open up tenders. I said we're in discussions with France right now. We've got a very good rating and a tough system. And another of the smaller European markets are starting to open up. So I would expect growth in the second half to be encouraging.

speaker
spk13

Next question please.

speaker
Nick
Moderator

We've got the next question from a piece of adult that's Siti, Peter, over to you please.

speaker
Peter

Yeah, thanks all. Sorry, two more for Luke, Pete Vidal here from Siti. On the IL-5 franchise, Luke, we're assuming biologics penetration in severe asthma, currently around 20 to 30%. Just interested to hear whether you had more precise data and thoughts or hopes where penetration could peak out. And then secondly, the NEPO COPD data does play out as you hope in terms of target clinical profile. How are you thinking about biologics penetrating in COPD? I mean, can the ramp be quicker than what has been seen in asthma in like pulmonologist already being experienced in biologics or would you take a more cautious view given the novelty of biologics as a treatment option in COPD?

speaker
Luke Miles
Chief Financial Officer

Yeah, Peter, I mean, I think like your numbers are very consistent with what we see in terms of tracking insurance databases, ATUs, position surveys, et cetera. If anything position surveys tend to overstate their usage. I think this is part historical. I mean, there are lots of parallels we've seen, of course, with TNFs and rheumatologists. When you see more recent graduates that have been trained and employed antibodies throughout their training, they're more comfortable with the utilization. You've also got the evidence trend is moving in our favor. There's an emerging and we've done some good studies here and plan to build on this around the capacity to drive remission through earlier intervention with antibodies. So with IL-5s in particular, Nucar, we published on that. So I think that's all working in our favor. With COPD, my expectation is, yeah, they would use it more actively because they've had a number of years of experience in asthma subjects. So let's see, of course, it's going to be driven by the strength of the data. And of course we have huge synergies with Prology, OREXV and the COPD treatment groups. So yeah, let's see.

speaker
Emma Walmsley
Chief Executive Officer

You know, obviously we're going to read, see the readout on Nucar, but then we have play in the rest of the normal, longer acting IL-5s and also the deal with low-stitch quarter in terms of where other technologies can take us. Okay, next question. Peter

speaker
spk08

Welford at Jefferies, over to you. Yeah, hi, I'll stick to one question. Just curious on OREXV with regards to the 50 to 59 year old, your degree of confidence that you'll get a positive CDC ACIP review of that, given some of the prior commentary of the earlier ACIP this year. And obviously not in the approval, but we're just thinking about the ACIP rather than the FDA. And if you could love to relate to that, any commentary you have on the recent headline data that you saw for an 18 to 59 year old cohort from your competitor and whether you think there's any commercial risk from the 18 to 50 year old cohort that there is there. Thank you.

speaker
Tony Ward
Q&A Participant

Yeah, so just quickly then, either FDA accepted the submission, we've got to produce the data in June, so it will be available for ACIP. And as Luke mentioned in the 50 to 59 population, we are focused on high-risk individuals. The data is just as strong as the 60 plus population. So I think we're in good shape for that particular decision. And then remind me what the second question is. You will leave the second question. Yeah, I mean,

speaker
Luke Miles
Chief Financial Officer

I think the other thing to factor in, Peter, is you've got seven new ACIP members now and a new chair. So the question will be, will you see a change in behavior? Now, if you look at the 18 to 59 with Pfizer and the commercial consequences of that, I mean, in the end, the bulk of this volume is going to be driven by retail business, 90%, and that's older individuals. And we've seen that pattern again with Shingwix. Remember, we've got the IC label 18 plus there, and it's a small numbers. It does help with contracting, but the 50 to 59 for us also helps with contracting. The younger individuals are more likely to be, the non Medicare population are more likely to be treated in the retail, e.g. maternal patients, et cetera. So, not too concerned about it at this point. And

speaker
Tony Ward
Q&A Participant

we're the first to submit a file in that adult population, in the 50 to 59 adult population.

speaker
Nick
Moderator

Okay, next question. We'll come to Tim Anderson at Walkway 6. Tim, over to you,

speaker
Tim Anderson

please. Okay, on depth of MoCAMAB, just your confidence in the level of, you know, in having compelling data and then your excitement about the commercial opportunity. To me, it seems like a twice-year injection would be quite compelling to make it the category leader, but maybe that's unrealistic. I can't really ever tell how excited you are about that program. Partly, Ann Blige is Nicola. And then just Blend Rep, pretty clear, coming back to market, do you think we're just completely past there being any commercial considerations on the ITox issue? Or do you still think that's gonna be something to contend with, given what else is available out there?

speaker
Emma Walmsley
Chief Executive Officer

Okay, well, listen, thanks, Tim. First of all, I'm gonna come to Tony and then Luke in a second on DEPI, which obviously the readouts are coming this coming quarter. And also we can hear on Blend Rep and the commercial impacts around ITox. But let me start by saying it's hard for you to understand why they're excited. I refer everybody to the meet the management that was done specifically on respiratory when we were clear we thought that PES sales and IR5s led by long acting and a lot of great data and research that I'm sure Luke can repeat. Means we think this is a very important pillar for us. And one of the most, as Judy mentioned earlier, important unlocks for us to see. But

speaker
Tony Ward
Q&A Participant

Tony, do you wanna keep it up? Yeah, so just remind you full data set available at the end of this half. So we'll update you on it next half. Confidence in the data comes from very clear PKPD relationships from our new caller experience. And I'd leave it at that actually rather than getting any more details.

speaker
Luke Miles
Chief Financial Officer

Yeah, so yeah, I mean, it's really interesting. I'm excited about Depomogamath. This is me excited, Tim. Yeah. It's

speaker
Emma Walmsley
Chief Executive Officer

a tough task for the Australian Act. It's a tax in 2017.

speaker
Luke Miles
Chief Financial Officer

Exactly, max in 2017. So yeah, you've got a validated mechanism that physicians are aware of. You've got this trend towards remission. You've got a part B component, which obviously has certain incentives in the US environment, which is encouraging. The physician has total control of compliance. And we know from our market research that patients would prefer something twice a year versus 26 times a year or 12 times a year or six times a year. So yeah, and then the other important thing is we've compacted the life cycle management. So all the indications, EGPA, nasal polyps, et cetera, arriving within two years of launch in contrast to new caller, with the exception of CFP, with in contrast to new caller, which is multi six plus years. So quite exciting. In terms of BlenRep, we'll present some interesting data at ASCO. As you know, hematologist oncologists are very comfortable managing toxicity. I think the main question historically was around the appropriate dose and the scheduling. Got a lot more insight from that, from dream seven, dream eight, and also some of the phase four work that we've done. So no doubt we'll cover that in more depth, but I think we've got a different picture. And then also helpfully, first line with the EMRD shift with the FDA is also helpful in terms of life cycle management with BlenRep and compression of launch time, for instance.

speaker
Tony Ward
Q&A Participant

Yeah, just to add to that, reversible transients and manageable, are the three words to think about. And I'll point you to a first line ISS study that was published at the European Myeloma Network in April, if you want to get a sense of what's behind those three words.

speaker
Emma Walmsley
Chief Executive Officer

Thank you.

speaker
Nick
Moderator

In the spirit of keeping this to the time I said, I think we'll have to close the call there. So Emma, if there's anything you want to just add in terms of closing the call. No,

speaker
Emma Walmsley
Chief Executive Officer

just to repeat, a very strong start to 2024, another course of excellent performance and critically continued pipeline progress. And this whole team and all that support them remain very strongly committed to delivering our potential and more. So we look forward to catching up with many of you on calls in coming days and over the months.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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