GSK plc American Depositary Shares (Each representing two Ordinary Shares)

and gentlemen, a very warm welcome to this GSK Q1 2025 results call. My name is Konstantin Fest, new head of IR at GSK, and I'm delighted to be joined today by Emma Warmsley, Luke Miles, and Julie Brown. I'm pleased to say Deborah Waterhouse, CEO of Veev, returned this week full-time, but David Redfern, chairman of Veev, will be covering HIV today. Tony Wood, our CSO, will also be joining us for Q&A. Today's call will last approximately one hour, with the presentation taking around 30 minutes and the remaining time for your questions. Please ask only one to two 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 will now hand over to Emma on slide 4.

Thank you, Konstantin, and it's great to have you on board. And welcome to everybody joining us today. Please turn to the next slide. GSK continues to make strong progress. Group sales were up 4% this quarter, core operating profit grew 5%, and core earnings per share also rose 5% to 44.9 pence. This performance was in line with our expectations and again demonstrates the quality, strength, and resilience of GSK's portfolio. Sales growth was driven by Specialty Medicines, our largest business, up 17%, with strong contributions from respiratory, immunology, and inflammation, oncology, and from HIV. As expected, vaccine sales were down 6% and general medicine sales were broadly stable. R&D delivery has continued, with two out of the five FDA product approvals we expect in 2025 now secured, and we completed the acquisition of IDRX, which adds another very promising oncology asset to our pipeline. Cash generated from operations was over £1 billion, providing further funds to invest in growth and to deliver returns to shareholders. Our dividend for the quarter increased to 16 pence, and we've commenced the £2 billion share buyback programme announced in February. Alongside this, we are proud to have sustained progress with our trust goals and estimate that in the last four years GSK has reached at least 2 billion people with our vaccines and medicines, including through our global health work. Finally, we're confirming the financial guidance previously given for 2025. Next slide, please. We continue to make good progress on delivering R&D productivity improvements and future growth opportunities. As we said at the full year, R&D is very focused on delivering the potential of 14 key pipeline opportunities, all of which are expected to launch between 2025 and 2031, and all of which have peak year sales potential of more than £2 billion. This portfolio demonstrates the strategic shift we've made to develop more specialty medicines, many of which offer long acting preventative type care and better adherence for patients. Along with the recent approvals for Penmenvi and Blue Jepa, we continue to expect FDA approvals for Nucala COPD imminently, Blen Rep in July and Depimokima by the end of the year. Innovation in our pipeline also continues to be recognised. Next, we received another breakthrough designation for our novel ADC targeting B7H3, and we look forward to sharing more data from our ADC programmes later this year. This quarter, we also presented data from our high potential HIV injectable portfolio at CROI, including positive data from our third generation INSTY, which advances our leadership position in the development of long acting agents to treat as well as prevent HIV infection. Our number one priority for investment remains growth through innovation, organically in R&D and with continued targeted business development. And we're specifically prioritising investment to key assets in RINI and oncology, alongside long acting HIV and core vaccine opportunities. On a broader investment front, we were also very pleased to break ground on our new state of the art manufacturing facility in Marietta, Pennsylvania this quarter. This is squarely targeted on increasing manufacturing capacity for new pipeline products in the US and means that GSK will have six manufacturing sites in America. Next slide, please. We remain highly confident in our commitments to growth. Whilst there are clearly elevated levels of uncertainty in the macro environment right now, including from possible sector tariffs, we start from a position of strength. Our momentum, together with the strength of our portfolio, the resilience we've built into our supply chain, and our proven capability to drive operating leverage, mean we have the ability and options to navigate and mitigate this. This underscores our confidence that 2025 will be another year of profitable growth and why we remain on track to deliver our guidance and our outlooks. With that, I'll hand over to Luke.

Thanks Emma. Please change to the next slide. In Q1, we delivered 7.5 billion pounds of sales, up 4% versus last year, demonstrating the resilience of our diverse medicines and vaccines portfolio. As Emma mentioned, growth in the quarter was driven by specialty medicines, which continued to more than offset anticipated headwinds in our vaccines business. By region, growth was driven by Europe up 11%, with the US up 4%, impacted by a challenging comparator base and the introduction of the IRA, which is previously stated we anticipate to be a 400 to 500 million pound headwind throughout the year. Next slide, please. Specialty medicines continued its excellent momentum, growing 17% in Q1, with strong performances across all therapy areas. In addition, three of the five product approvals we expect this year are in specialty medicines. That's BlendRep, Nucala and COPD and Depil MicroMod, and I'll talk about them shortly. R&I was up 28% in the quarter, and within that, Benlister, our treatment for lupus, grew 39%, and Nucala, our anti-IL5 biologic treatment, grew 21%. With both of these benefiting from strong demand, as well as the comparator, which saw US channel inventory reductions in Q1 last year, a bettas of which will not repeat in the remainder of the year. In oncology, Q1 sales were up 53%, with sales of gemperley and ojarra more than doubling. Gemperley, the only -oncology-based treatment to show an overall survival benefit in endometrial cancer, continues to see increased patient uptake in the US and Europe, following all countries' approval for primary and advanced or recurrent endometrial cancer. And ojarra sales were driven by high US volumes and strong uptake following the new market launches in Europe and international. And this market expansion continued in Q1, with launches in Spain and Italy. We expect very strong momentum in our specialty medicines portfolio to continue and reconfirm our 2025 sales guidance of the low double-digit percent increase. Next slide, please. Innovation is our priority, and we've got three exciting approvals expected in specialty medicines this year. BlendRap was approved in the UK earlier this month and has an FDA-ponufed date in July, with a projected overall survival benefit of 33 months in Dream 7 compared to standard of care, manageable safety profile, and low treatment burden. Feedback from physicians is that BlendRap could redefine second-line multiple-mild loan treatment. Dose interruption enabled and managed ocular side effects, and it's an immediate 30-minute infusion administered in a community setting, which is where severe disease patients are treated in the US. We're also being very thoughtful about the launch, which, as I've said in the past, will be staged. We'll work -in-hand with individual physicians and patients to ensure dose management is understood and the ophthalmic support network is in place. Laying this groundwork will help firmly establish BlendRap in the second-line multiple-mild loan market and demonstrate the benefits of this transformative medicine. Turning to respiratory, GSK has been a leader in the prevention and treatment of respiratory disease for more than five decades. In 2015, we launched Nucala for severe asthma, the first monoclonal antibody to target IL-5. Next week, we're expecting FDA approval for a major new indication to Nucala to treat COPD, the third leading cause of death worldwide, affecting more than 300 million people globally. We've got an experienced field force in place and are ready to launch. We expect to share the full phase three of the MATNA trial results very soon, including data on the reduction of most serious exacerbations, which lead to hospital presentations, which are known to be the strongest indicator of disease progression and death. Also in respiratory is Depamocomab, our exciting new -IL-5 medicine with six-month dosing, which has been filed in all major markets for approval in both severe asthma and chronic rhinocytosis with nasal polyps, with a US FDA decision expected towards the end of the year. In a pooled analysis of the swift pivotal studies in asthma with type two inflammation characterized by blood in centerfold count, Depamocomab demonstrated a 72% reduction in exacerbations requiring hospitalization and feedback from the asthma community on these data have been very positive. In a poll pulmonologist 86% think Depamocomab could become a new standard care and 82% said they would consider prescribing Depamocomab ahead of alternative biologics. So this is this is clearly a significant opportunity to increase the uptake in binary naive patients given rates and asthma remain low. We estimate that only around 21% of eligible asthma patients currently receive a biologic with patients potentially benefiting from increased adherence from a twice yearly dosing schedule. And we anticipate Depamocomab will also capture share from shorter acting alternatives. And this underpins our confidence in Depamocomab's multi-billion pound peak year sales potential. I'll now hand over to David to cover HIV.

Thank you, Luke. We continue to deliver strong growth and momentum in HIV treatment and prevention with sales growing 7% driven by competitive execution and strong patient demand for our industry leading innovative portfolio in Devato, Cabanuvra and Apertude. All with gold standard integrase inhibitors at the core. In the US, we saw strong double digit volume growth driven by long acting partially offset by some impact from the implementation of the IRA and from channel mix. Our leading oral to drug regimen Devato continued to grow strongly in all regions at 19%. While our long acting injectables Cabanuvra and Apertude grew 38% and 63% respectively. We remain delighted with the strong and continued momentum of our long acting portfolio. Cabanuvra is the first and only approved long acting injectable regimen for the treatment of HIV with 77,000 patients globally now benefiting from this transformative medicine. We shared data at the CROI conference in March, demonstrating Cabanuvra's high long term effectiveness in real world studies, including almost 15,000 people living with HIV. These data underline the high patient preference and treatment satisfaction for Cabanuvra compared to daily pills. Apertude, the first and only approved long acting option for HIV prevention is now benefiting 21,000 individuals in the US. We remain confident in the competitive profile and growth of Apertude with strong efficacy at more than 99%, safety and importantly overall tolerability across broad populations. At CROI, we also shared implementation study data showing zero cases of HIV acquisition, as well as high persistence addressing adherence challenges some face with orals. The potential for the long acting market remains significant with the total HIV market today worth more than 22 billion pounds and with treatment accounting for 90% of this. We expect the use of long acting injectables to continue to rise significantly through strong patient demand, position belief in the unique benefits and increased infrastructure to support their administration. Given the strong start to the year, we remain confident in our 2025 guidance of mid single digit percentage growth driven by strong volume growth, partly offset by pricing dynamics through the IRA and channel mix. Next slide please. At CROI, we shared exciting data highlighting our great HIV pipeline progress, including three high potential assets in our treatment pipeline. Delivering the best resistance profile of any entity we've seen to date, we were delighted with the Phase 2A data for our third generation entity, VH184. Results demonstrated rapid and high potency, positive safety results and no drug resistant mutations. This promising early data supports further development of VH184 as the backbone of our next generation of HIV treatment regimens with IP cover through to 2039. We also shared Phase 2B data showing our BNAB N6LS achieved high efficacy and tolerability. These results combined with pharmacokinetic data support progressing this asset to explore six monthly dosing. We look forward to seeing Q6M data in the next phase of this study. Moving on to VH499, our investigational capsid inhibitor. Data from a Phase 2A study also showed potent antiviral activity and favorable safety, again supporting further development of this asset. With these multiple data readouts, we remain on track to confirm the assets that will deliver six monthly dosing for treatment in 2026 with our Q6M Registrational Study Start planned in 2027. As you can see on the slide, we expect our Q6M Regimen to contain a combination of one of three long acting entities, CABULA, VH184 or VH310, with either our BNAB N6LS or VH499 our capsid inhibitor. And then turning to Q4M, our PrEP bridging study is fully recruited. We expect data in mid 2026 and we anticipate starting our Q4M Treatment Registrational Study by the end of this year. As pioneers in long acting injectables, we are focused on the next generation of HIV innovation with integrase inhibitors, the gold standard for HIV treatment and prevention at the core. We remain confident that our pipeline, including three new entities in development and five planned launches, will continue to drive performance over the coming decade and we will share more at a Meet the Management event in Q2 2026. With that, I will hand back to Luke.

Thanks, David. Turning to vaccine, sales for Q1 were over £2bn, down 6% on last year in line with the expectations. Shingwick sales declined 7%, with growth in Europe partially offsetting lower sales in the US and international. As anticipated, the pace of penetration in the US is slowing, with cumulative immunisation rate reaching 41% at the end of 2024. Sales and international were impacted by the annualisation of rapid uptake from the National Annualisation Programme in Australia in Q1 2024 and the agreed low supply to our co-promotion partner in China. In Europe, strong growth was driven by the excellent launch of France and good performances in other European markets, including Spain, the Netherlands, Italy and Greece. Shingwix is now launched in 54 markets, with recommendations in more than 40 markets and nationally involved burst on programmes in 24. Growth outside the US this year will be supported by expanded funding, the launch in France and a new Japanese national subsidy for shingwix vaccination. The average immunisation rate across the top 10 markets outside the US is now around 8%, so there's still a significant opportunity for shingwix ahead. In meningitis, our portfolio was up 20% in Q1, with strong double-digit growth across Europe and international, primarily driven by Bexarro. In February, we received US FDA approval of our new pen-devalid vaccine, Penmenvi, and we're pleased to also have received a unanimous recommendation from the Advisory Committee on Immunisation Practices, or ACIP, to the CDC. In time, we expect this vaccine to simplify immunisation schedules, increasing coverage and protection against a serious life-threatening illness. Turning to RSV, OREXY sales were down 57% in the quarter against a challenging comparator and the impact of restrictive ACIP recommendations. However, OREXY continues to be the US market leader retaining 55% of the older adult vaccination share. Two weeks ago, ACIP voted unanimously to recommend adults aged 50 to 59 at an increased risk to receive an RSV vaccine. We welcome the expanded recommendation, which opens up access to a cohort of around 13 million people in the US. Although in the current vaccines environment, we don't expect a significant upside this year, and this market will take time to build, but we remain confident in the long-term importance of this vaccine. We also presented a 36-month immune response data from a 004 study, and the data provided evidence to support future revaccination with OREXY underpinning our strong belief that a revaccination will be required with our base case at five years. We also expect more data on this in 2026. Outside the US, OREXY has launched in 37 markets, with recommendations in 18 of these markets, and national reimbursement programs in six with more to come. Although it's pre-season, we are seeing some early access momentum outside the US, and particularly in Germany following recommendation and reimbursement. As expected, established vaccine sales were impacted by non-repeating prior year sales partially offset by higher US demand for our measles, mumps, and rubella vaccine. Overall, we continue to expect vaccine sales to decrease below single digit percent in 2025, while remaining confident in the medium to long-term prospects of this business and pipeline. Turning to general meds, respiratory sales were up 1% driven by Trilogy, which was up 15%, which benefited from a continued patient demand, sick clath growth, and increased blood share. Trilogy is the number one brand in aspirin CRPD worldwide, and it's the cornerstone of our CRPD treatment portfolio, and is soon to be complemented by our new biologics that are an add-on to Trilogy, a standard of care, cementing our leadership in the CRPD space, and reflecting our long legacy of leadership and respiratory health. Overall, general medicine sales were stable in the quarter, with other general meds down around 3%, owing to continued generic competition as expected. In March, we received FDA approval of Blue Jepa, a new antibiotic treatment to treat uncomplicated uro-tract infections. We're on track to launch the second half, and we will focus on building access over time. Later this year, we'll be pursuing a regulatory decision for the second indication in uro-treat genital gonorrhea, and we plan to build on our anti-infectives portfolio in the coming years. Overall, for the general meds portfolio, we continue to anticipate sales to be broadly stable in 2025. I'll now hand over to Julie.

Thank you, Luke, and good afternoon, everyone. Next slide, please. Starting with the income statement for the quarter, with growth rates stated at CER, GSK has started 2025 well, carrying momentum through from 2024, with sales increasing 4% and core operating profit growing 5%, against a very strong comparator base of 35% growth last year. Sales benefited from the continued strength of specialty, up 17%, more than offsetting the expected decline in vaccines. Volume growth more than offset price erosion, stemming from the Medicare Part D redesign implemented at the start of the year. And as Luke mentioned, the impact of this through the first quarter was in line with our expectations. Turning to the income statement, we have delivered another quarter of operating leverage. Growth profit benefited from product mix as the portfolio continues to transition towards higher margin specialty medicines. SG&A increased 8% year on year, but 4% excluding the Zasula Royalty Credit last year. And royalty growth was up 21% driven by prior year true ups. These factors have supported the delivery of 5% operating profit in EPS growth or 8% operating profit growth, excluding the Zasula Credit. Turning to the total results, the significant growth in operating profit predominantly resulted from lower CCL charges compared to last year and foreign currency movements. Next slide please. This chart illustrates the substantial margin progression we have continued to deliver on an underlying basis. Driven by benefits from the transition to specialty medicines, as well as our ongoing disciplined returns based approach to investment. Core operating margin improved to 33.5%, up 130 bips, excluding the prior years Zasula Credit or 30 bips year on year in total. Accretion was driven by mix as gross margin benefited from the strong growth of higher margin specialty medicines, including one-off benefits from New Carle and Ben listed comparator bases, as Luke mentioned. We continue to invest in our key products, including Blenrep, Depamocomob and Dojara, with underlying SG&A rising broadly in line with sales. And for the full year, we expect SG&A to grow a low single digits as we allocate resources to support our launches over the coming 12 months. R&D grew marginally below sales this quarter and is expected to accelerate as we progress through 2025, driven by investment in our next wave of key specialty pipeline assets. Next slide please. Turning to cash flow with commentary before the one-off impact of Zantac payments. Cash generated from operations was 1.4 billion. CGFO improved 0.2 of a billion, reflecting higher operating profit and favorable movements in RAR, partially offset by adverse movements in receivables, driven by higher O'Rexley and Schingrich's collections last year. Free cash flow improved by 0.5 of a billion, excluding Zantac, supported by a favorable CapEx comparator that included upfront BD payments last year to Hanzo. Zantac payments this quarter totaled 62 million and we now expect 1.2 billion of payments to be phased over the remainder of 2025, with 0.5 of a billion expected in Q2. Next slide please. Through the quarter, we've continued to deploy cash in line with our capital allocation framework, whilst ensuring this remains underpinned by a strong balance sheet. Free cash generation pre-CapEx was over 1 billion pounds, which supported investment in our oncology pipeline through the purchase of IDRX, as Emma mentioned earlier, and our continuing commitment to shareholder returns. We have returned over 0.8 of a billion to shareholders through the dividend and the buyback, where we completed nearly a quarter of a billion pounds in Q1. We remain committed to investing for growth and providing attractive and growing shareholder returns. Next slide please. We're very pleased with the business performance, which is outlined was driven by strong growth of key products and higher than anticipated royalties. These results reinforce our confidence in the delivery of our full year 2025 guidance of -5% sales growth and -8% operating profit and EPS growth. Royalty income for the year is now expected to be higher than previously guided at 750-800 million, including an IP settlement relating to RSV, agreed in April, comprising an upfront to be credited in Q2 and a future royalty stream. This additional income will be reinvested in the pipeline this year, with R&D investment growth now expected to be slightly ahead of sales. In terms of phasing, we continue to expect profit growth to be second half weighted, albeit to a lesser extent than previously anticipated, with Q2 now benefiting from the IP settlement. More details around phasing and the modelling assumptions are contained within the appendix. Looking beyond, we remain confident in our medium and longer term outlooks to 2026 and 31. Should tariffs be imposed, as Emma mentioned, we are well prepared and start from a position of strength. We have identified potential mitigating options in supply chain and increased productivity initiatives, and we remain committed to sustained investment in our pipeline and launches. Next slide please. Turning to our roadmap, on the back of 13 positive Phase 3 readouts last year, GSK has carried pipeline momentum into Q1, with two new US approvals as highlighted. Looking ahead, we expect three more approvals for new Carlos COPD, BlenRep and Depa MochaMap this year, with Purdue for dates in May, July and December respectively. We expect all three to be important growth drivers for GSK. And over the next two years, we expect this momentum to continue as our pipeline delivers new growth drivers and we look forward to 15 Phase 3 and pivotal study readouts in respiratory hepatitis, long acting HIV and oncology. And with that, I will hand back to Emma for her closing remarks. Thanks Julie.

So to summarize GSK is delivering with a good start to the year. Momentum in our portfolio is supporting our ability to continue to deliver mix improvement, operating leverage and cash flow. Despite the environmental uncertainty, we continue to expect 2025 to be another year of profitable growth and we remain very focused on investing in the pipeline, targeted business development and successful launches to fuel further growth, to achieve our potential and more for patients, shareholders and our people. Thank you very much and with that we will now open up the call for Q&A with the team.

Thank you Emma. To ask a question, please click the raise hand feature via the webinar controls or dial star 9 on your phone to raise your hand. You will be prompted to unmute yourself to state your question. Now the first question. First question comes from James Gordon from JB Morgan. Go ahead.

Thanks a lot, James Gordon, JP Morgan. Thanks for taking two questions. First question would be new launch expectations. So two important approval decisions coming up. New carless CFPD May 7th and Blen Rep July 23rd. So assuming things are still operating as normal with FDA and you get the timing approvals, what are your latest thoughts in terms of how those launches go? What are the gating factors and best precedents for how they go? Could we see strong uptake already in age two or are these more 2026 stories? I guess I'm thinking for Blen Rep, could ocular talks and education around that or other things you need to do around that be a barrier to a fast launch? And for new carler is do PCFPD the precedent? That's the first question, please. The second question was on tariffs. So I heard the comments have been well positioned and also that there could be some mitigating options and productivity offsets. So can you elaborate? What would the impact be? Let's say it's a 25% tariff from bringing products from outside the US into the US. What would the impact be on GSK and how quickly could you have these offsets or productivity benefits? Would it be that you'd actually move US manufacturing or something else? And is there like an inventory or other cushion? Is that what you could be referring to?

Right, there's quite a lot in there. But let's start with what matters most, which is the exciting new launches we're bringing. And, you know, across that portfolio loop, perhaps you'd like to kick off there and then I'll go back on tariffs.

Thanks, James. Yeah, a lot there. So I'll cover in order and Tony jump in if I miss anything. I'll go through new Carla first. I think I'll touch on Penelope because we'll get questions on that. Get the mark on that and blend rep. I won't cover BlueJet because I covered that in the opening intro. I think first with new Carla COPD, I mean, yeah, May 7th, Bidoof is on track. The MAP-Nade data is going to be published very soon. It's limited what I can say, but in big picture terms, in terms of apples to apples comparison to the JUPI, I think we're very competitive. We also had a wide spectrum of patients, so emphysema, combined emphysema and chronic bronchitis patients and then, you know, singular chronic bronchitis patients as well. So from a physician point of view, that's very appealing because it can be difficult to stratify these patients at time. So that's simpler for their practice. The important thing when the results are released, the trial was designed to look at hospitalisation and emergency department visits, which the JUPI studies didn't in their protocol design. So that's an important measure when you look at pulmonologists and what they consider to be critical when they're employing a biologic in these refractory patients. If you look at market research, it's very supportive and that's grown over time. About 83% of pulmonologists, when we show them the profile of the product, are very motivated to use new cholera and COPD. Now, I would counter this with pulmonologists generally are pretty conservative in their usage of biologics. I said earlier around 21%. So I think that, you know, that needs to be, you know, in terms of your ramp, factored in. The other thing with that, of course, being second, we're looking very, very closely at JUPI, where their access is, the user base, why people are using it. So I think we're very much looking forward to the launch. We've had a whole successful series of indications and expansions with new cholera. So the capacity of doing this is, you know, I think we've got a good track record. So we're looking forward to having fun with competing against Sanofi there. In terms of Penmenvi. Luke,

sorry, before you go on, I just want an additional point to stress for the study. And as you say, we're looking forward to presenting the data very soon now. Important to recognize that the study was conducted over a two-year period. That is critical for a disease whose survival rate at five years is only 50%.

Yeah,

absolutely. And

I think 11% mortality rate, if you are admitted, which again is why, you know, when we do the surveys with physicians, they cite hospitalizations as a key parameter. Okay. Now, in terms of Penmenvi, so that's our pentavalent meningitis vaccine. Just as a reminder, we have a very strong position as a global leader in meningitis. And with Bexarro, our MenB vaccine, we get about 75% market share in the US. That's really driven by it's 110 strand coverage and is really perceived to be the stronger of the two MenB vaccines. That's important because when you deploy or use a pentavalent vaccine, you then to use with the subsequent B follow up that I explained in a minute, you need to use the B vaccine that was embedded in that pentavalent, which we believe gives us a good position. So we've passed the first of two steps. So FDA approval and then the ACIP recommendation on April 16th. The schedule that's signed off is the same as Pfizer's and I mean, it is more complex and ACIP has signaled that they intend to evolve this, which I'll come back to in a minute. But basically, if you look at the numbers today, first shot is with ACWY, which is stipulated as a routine vaccine by ACIP in the US. So about 90% of kids in the US actually get that vaccine. Then when you have these kids progress to 16 to 18 years of age, so adolescents, the schedule is that they should have ACWY as a routine. And today about 60% of those kids get that vaccine. So quite a big drop off. Now the position at that point based on shared clinical decision making can either use, well can use a B shot and around 32% of kids get that shot in the US. And then there's a subsequent follow up second booster shot with meningitis B, but only about 13% of adolescents or children in the US get that one. So quite a substantial drop off from 90% down to 13%, despite the fact that B is a very, very challenging and potentially lethal strain. So what ACIP signed off on the other day was that instead of that ACWY-B combo, after that initial ACWY shot, using shared clinical decision making, the pediatrician can elect to use Penta, a Penta vaccine like Penmenvi, and then follow that up with a B. So if you're confused at this point, then again, a lot of pediatricians are confused. They have to stop four vaccines. Now where ACIP has indicated where they want to go, and that's the third step, it's a simpler regime where basically it would be ACWY initially, but the Penta and then B follow up would be risk based. And that's an important shift because with risk based, that supports a broader use. It enables physicians to look specifically into who should be vaccinated. So for example, 18 year old going off to college would be a classic there. And it's an opportunity for us to expand coverage. So again, you know, initial launch now with Penmenvi will be relatively small because of this change that pediatricians and payers are waiting for. And the aim is ACIP has signaled that they will look at that in October or early next year. So hopefully they cover that in October. Okay. Third one. Anything on that one, Tony? No, you're good, Todd. So DIPA MochaMab, very, very exciting. I think the more that this product is pro-part, remember we can't promote these products. They're not approved. Physicians get access to the data through academic congresses, publications, et cetera. And again, I think the main problem when you look at biologics is just the lack of penetration despite excellent insurance coverage and you know, a really high burden for these patients in terms of severe disease, exacerbations, hospital admission. But still, as I said earlier, only 21 percent of patients get a biologic. And what's interesting is if they do get a biologic, about 65 percent of them across biologics discontinue in the first 12 months. So to me, that's very, very attractive for an effective or long acting, you know, two shots a year, which really reduces patient burden. It gives the physician confidence that the patient has coverage and the shot will be in the U.S. given within the clinic. So the physician has total control of efficacy and that patient. When we look at market research, it continues to strengthen. So if you I think this is a great test. If we ask HCPs in Europe and the U.S. in the U.S. 45 percent said they'd use it and buy it by naive immediately. Around 54 percent in Europe. Again, that's without education promotion, et cetera. And then 66 percent of them in both the U.S. and you would consider switching established patients on on biologics across to depth of motor map. And then when we look at patients, six out of 10 patients say that's clearly easier for them in terms of versus every two weeks that they have with your pillar map right now, going to twice a year and nine out of 10 said they'd switch if their doctor recommended it. So I think we've got an evolving, very, very competitive product here. You know, we've established success in severe synavellic asthma. The target is well known. The profile is established. So, again, I think that one we should see an encouraging launch in about. Yeah, I mean, in terms of the source of patients will get about, you know, we're talking about half of them. That's what we want to target initially is to get naive patients who don't have obviously complicated histories on the product. But again, I think the difference, the other 50 percent, some will come from New Carla, some will come from other products. And then finally, anything on that one, Tony? No, finally on Blenref. I mean, again, yeah, on track in terms of the July approval date. I mean, the dream seven data, I think is when we look at market research is incredibly compelling. I think one night of caution when you do see other surveys, we're not out there promoting the product yet. So we're limited, obviously, in what we can do beyond publications and presentations. But clearly, I think the progression of Daratumumab into the first line opens up a big opportunity for Blenref in that second line. But some cautious in terms of how we introduce it, because if you look at the options that they have in second line right now, particularly if you're a community based hemonchologist who treats 70 percent of these patients and clearly want to retain these patients in their practice for as long as they can. That Blenref really is a compelling option. You know, they're not really seeing CAR T as an option in the community because of the complexity of CAR T. And I think as CAR T's evolve, the benefit risk profile continues to become more complex. If you look at bi specifics, then again, a very rigorous induction process, hospital admissions, complicated dosing, you know, highly frequent dosing. And I think what's increasingly emerging is this infection risk, which right now when we look at market research, it seems like community based hemons are under representing that versus what the data has been published so far. So I think as they start to use those products and get experience with them, that will increase. In contrast with Blenref, we've got a very, very well known benefit risk profile with 7000 patients being exposed. Clearly, we know the focus needs to be on managing the ocular side effects, which are reversible. I mean, I think the stats, Tony, if you wanted to cover that in terms of just how many patients are impacted, how quickly it reverses, maybe you want to give some color on that. Yeah, let me just on

some data before I get into that reminder for everyone that we have a 42% reduction in risk of death from the DREAM 7 study. That is a projected 33 months of additional life. And then just to quickly cover the numbers on the ocular side effects, they're important. 66% of the individuals on the DREAM 7 study had no vision changes. 32% had blurred vision, but that was for only 11% of the total time on treatment and only 2% had serious effects, which were all reversible.

Great.

We're busy.

Yeah. So I think, you know, at a headline level, James, these are important launches with meaningful data for patients and prescribers. I think we are cautious in terms of materiality of contribution this year. Luke has often described the Blender Lab launches go slow to go very big. And we know that whether it be there or in our ongoing emergence of oncology or indeed in respiratory, these are very material contributors to the next chapter of growth on the 26th and 26th to 31. Quickly on tariffs. I'm not going to add a huge amount to what's already been said. First of all, what's in our guidance for this year is obviously the tariffs that's already been announced. But I'd refer you to our press release where we're very specific that, you know, in the face of potential sector specific tariffs, and we obviously have been very focused on preparation in a lot of detail and we look carefully at other two, three, two reviews. You know, we think we have multiple levers and we see we have multiple levers at our disposal to both navigate and mitigate this. And the three main ways we think about this are first of all, already through the enormous amount of deliberate work that was done through the separation to create regionally resilient supply chains. You know, it was good to see, as I said, us break around on the six manufacturing site and most of our US products in some way touch the US supply chain as well. And we have dual sourcing when we look across other regions. Obviously, we were delighted, secondly, with the shift in the gross margin through our deliberate intent on more specialty products. And then thirdly, it's about delivering and accelerating already identified productivity improvements, you know, across various areas in the P&L. But we definitely believe we have further opportunity there. So, you know, we are prepared. We have a lot of agility and detailed work underpinning this. And, you know, we think we can navigate and mitigate in the interest of patients and GSK shareholders, which is where we're confident in our reaffirmation of outlooks. Next question, please. I'm hoping we've covered an enormous amount on the launches already, which made sure some

of the others. Next question comes from Terry Hall Ford from Berenberg. Please go ahead.

Thank you very much. A couple for me, please. Firstly on vaccines. I wonder if you can talk to your experience so far with the new US administration, vaccine business demand, I guess, given the negative rhetoric. Are you seeing a negative impact on the demand of your vaccines in the US, particularly within the paediatric space? And love to hear your views on whether there is a risk now that RFK Junior makes it more difficult to secure future approvals, perhaps here indeed at some point, a booster for a Rex-themed future. So just your your feedback and your views on the US vaccines market as it stands today. And then secondly, on Medicare Part D redesign, I think you did reiterate the 400 to 500 million headwinds for the year. And you did say, Julie, that it was within your expectations in Q1. I wonder if you can quantify that. And also, do we expect around half of it still to be centered on HIV?

Thank you. Yeah, I mean, Julie may add to that, but I would say we are absolutely spot on on where we thought we would be around the Part D impact and including by by products area. So HIV, you're right. And anything else

on that? Yeah, no, I think I think it's a good summary, Carrie. We were bang on expectations. HIV is the largest part with 150 to 200. Specialties the next one because they tend to be the more expensive medicines and then the balances across vaccines and gen med. We've treated it on a straight line basis over the quarters. So the cost of it is evenly spread throughout the year.

Yeah, and on vaccines, we get Luke may want to add to this, but we gave, as you know, a cautious outlook on the year on vaccines. We're exactly where we thought we would be at this stage. And remember, with a really challenging comparison versus versus last year on our vaccines business, none of this takes away from our fundamental confidence in the field. And our ambition for the pipeline over the medium term, we see separate between speculation and actual experience. And, you know, obviously, it's been good to get the approval of Pemmendia way and a double unanimous vote. So we have to see where CDC comes out. I mean, look, in terms of what we're seeing in terms of consumer behavior or, I mean, pediatrics, you commented actually. Yeah, we could hear anything. Yeah,

sure. Thanks, Emma. And yeah, Kerry, I mean, I think there's a couple of ways I can cover this. I mean, firstly, you know, the facts are that ASAP has just given the green light to a pediatric vaccine with Pemmendia. So I think that's encouraging. Of course, it needs a signature. But I think that's a good directional sense. If you look at our established vaccines overall, which include a lot of pediatric vaccines like MMRV, they were down a little bit, but that's really due to phasing. So I say three phasing in Canada, Rabipur and some EU clawbacks, whereas our MMRV vaccine in the US, I mean, overall is up 25 percent. So I think that's also encouraging. If you look more broadly, we do track vaccine hesitancy and attitudes to vaccines. If you look within, I think, you know, one of the numbers I was looking at the other day is within a rec fee. If someone declines a rec fee, right, it's strongly recommended by physicians, particularly the 75 age group. So 75 plus age group. When we look at why does someone decline and not do that? So only in 17 percent of the cases that they say they're against a vaccine. So, you know, let's let's see in time. But, you know, so far, so good. I think with with a rec fee, the impact is more predating the current administration was really ASAP's decision in June of 2024, which no doubt we'll get back to later on. But I overall, I think, you know, the point, you know, cautiously optimistic in terms of the direction that we're saying,

you know, specific question on revacs. As you know, our base case for that is five years. We the data that will be presented on that as much is going to be coming through in 2026 and the earliest if it's a five year base case, I mean, let's see. But that is until 2028. Honestly, I think this will have the current, if I can say, environmental uncertainty will have settled down pretty clearly by then. And obviously, you know, ongoing questions around Covid vaccination are pertinent for us. Next question,

please. Next question comes from Joe Walton from UBS. Please go ahead.

Thank you. Can you hear me? Yeah, excellent. My two questions, I guess, both for Julie. So looking at SG&A, four percent, excluding the, you know, the base comparison. And you've got such a lot of new products to launch, even allowing for the fact that in respiratory, you know, you've already got people there as it comes to the antibiotics, as it comes to camlapixent, et cetera. I wonder if you can just tell us how long you think you can keep that SG&A growth so low and still be utterly confident that you are giving the very best support that's required for those new products coming through. And secondly, and it's sort of tariffish related. Can you just explain to us or confirm for us that when you ship product around and you ship stuff into the US, it's largely at a sort of API type price, so that any tariffs that were put on would presumably be relatively absorbable. We note that in your annual report, you do take quite a big benefit from intellectual property regime elements, and that's presumably an ability to do that in the UK and in particular in Belgium for vaccines. So I think there is some concern that maybe when you ship your vaccines across to the US, then maybe they go off at, you know, a high price, including some sort of element of royalty, and that would be more difficult to absorb. So it's just the, you know, the tax sort of and just that confirmation as to how you move your stuff around so that we can, you know, do our own work on what broader tariffs might mean to your business initially. Thank you. Okay,

thank you very much, Joe, for the questions. In terms of SG&A, obviously I'm working very closely with Luke and the team on this, and I'll invite him to comment as well. We feel we've got an opportunity. The areas we're launching products in are the areas where we've got a very strong position already, possibly with the exception of oncology, which we're still building, but we're very strong, as you know, in respiratory, you've heard referred to it already. There's a real synergy we found between EREXV and Trilogy as an example in terms of the launch of EREXV and the benefit also on Trilogy. So we've worked this through very carefully. You know, we do a multi-year plan. We look at the launches, we look at how we can reallocate resources from the more mature lines, and we use marketing mix models and various other tools to understand the, I guess, the response rate to the marketing investment that we're making and the field force investment we're making. And, you know, our basis is driving continued productivity, and you've seen us drive the P&L quite strongly in terms of the leverage we generated last year, you know, eight on the top and 13 on the bottom, and the same this year. We continue to do this. So yeah, we're very committed to doing that. I think if

we were having this conversation five or six years ago, we'd be talking about a primary care structure, etc., whereas, you know, the reality is we've evolved it extensively. And when you, I mean, the products I just covered before, these are dramatically more concentrated resourcing events, smaller sales forces, less DTC. So yeah, very confident that we can support these products and evolve it. And, you know, that's really our core, you know, bread and butter day job to do that. And again, as the mix moves to more specialty dominated, that gets easier, of course, because of the factors that Julie's just outlined.

Right. And just on tariff, yeah, on the tariff point. Tax. Yeah,

in terms of obviously the supply chain, our supply chains are inherently complex. We've quite frequently, as Emma mentioned, as a result of the demerger, we've got often dual sourcing. The majority of our products are touching the US in some way through the supply chain. Including vaccines. Including vaccines. Yes, absolutely. And therefore, we wouldn't be in a position of obviously when we were calculating the value of the tariff, if it came, it would all be based on the customs value. And therefore, the API is actually not that relevant in terms of the pricing of this. As Emma mentioned at the beginning, we have done a lot of work on this. We've looked at multiple scenarios. We're very confident in our position, which really stems from the supply chain dual sourcing. And it also stems from the productivity initiatives, which are well underway in the company that we're totally committed to delivering. Great. Thank you.

Next question, please.

Next question comes from Graham Perry from Bank of America.

Hi, Graham. I think seeking the questions. I should just follow up on that point on tariffs actually. So if you've got productivity initiatives there, what's incremental in those? Is R&D, for example, a target? And why wouldn't you have just been doing these before? Secondly, just wondered on Shingrix, if you could quantify the sales into China, where Zifei with inventory and actually do you think you could see some sales this year through the course of the remainder of the year? And then last one was just on EREXV. The 36 month booster data that you showed, which showed at Aesopan, the ISRV conference in Brazil, actually showed a lower antibody boost than you saw at the 24 month data. So what gives you the confidence that the vaccine is boostable at all? Because that's sort of staying low and is at the sort of level that saw no incremental efficacy benefits at the second season. Thank you.

Thanks. I'll come to Tony to talk about REVAX where we still have high confidence. That's the most likely scenario. And Luke may want to sentence or two on Shingrix. But just to be clear in terms of productivity, of course, this is about our ongoing continuous work to improve the productivity. And I would say primarily in SG&A where we do have sufficient spending, Luke and Julie have really emphasized, of course, we all know the best way to drive leverage is better top line. And that's going to be through focusing highly efficiently and effectively on our growth driving products. But there is always opportunity to do more. By the way, technology is advancing all the time to enable us to do more. Now, there is ongoing work in terms of continuing improving the productivity of R&D. And likewise, we're going as fast as possible. But as Julie said, our first priority is to continue to increase investment behind the acceleration of the pipeline, whether that be the delivery of the current way or arguably, just as importantly, making sure we set ourselves robustly for ADCs for the next wave of COPD, for further lifecycle innovation, for the accelerated delivery of the BD we're doing, which is why we want to use the second that we've delivered to increase investment in R&D later this year. So we're going at all of it as hard and fast as we can. And we see that as one of the levers to pull as we navigate through potential scenarios, which we absolutely do take into account with our modelling forward. But Tony, do you want to quickly comment on REVAX and Luke Grant's sentence on China? Just

a couple of great points. And Graham, as you appreciate, there's no vaccine efficacy correlates established yet. Just to remind everyone in terms of the three season vaccine efficacy data that we have in the lower respiratory tract population, we go from 83% efficacy in season one to 48 in season three. So we are seeing waning. The immunogenicity point that you raise is a baseline effect. And if you stratify individuals within that study by their baseline, you see a greater boost with lower baseline. Great.

Yeah, thanks, Graham. I mean, on China, like I've described as a work in progress, but we are making progress, but it takes time. I think this, you know, we have the right strategic partner. We reshaped the arrangement. But I think the macro and POV point of vaccination dynamics we're watching very closely, but we are seeing encouraging trends. We had around 50, 54 million sales in China in Q1. And we're maintaining a market share of about two thirds versus Gunway, which is good because I think that the one third of Gunway patients are not our target business anyway, because of their out of pocket sensitivity. So, you know, if we have deliveries and we're watching this closely, they'll be for the second half.

Yeah. And, you know, I think we've been pretty cautious in our outlook for China for this year because of the broader macro, as you'd all understand. Next question, please.

Next question comes from Simon Baker from REVAX.

Hey, Simon.

Thank you for taking my questions. Two, if I may please. Firstly, on the PrEP market, it was a strong performance by Apertude. Gilead reported strong numbers for Descovy and they cited broader awareness of prevention and actually cited your promotional activity. So I wonder if you could just give us an update on the dynamics within the PrEP market in terms of switches versus new to prevention. And related to PrEP and the US, is there any impact from the shutdown of USAID on clinical trial recruitment? I was thinking of studies like the Palisade study, which is still showing us ongoing recruiting and others have suggested that USAID is quite handy in terms of trial enrollment and coordination. So any thoughts on that would be helpful. And then one for Tony on Camelopix. And we've got the Calm 1 study coming up in the second half of this year. I just wonder what a good result looks like there and how relevant is the data that was recently published on the Sood study as a roadmap for the likely outcome of phase three and what constitutes a good result. Thanks so much.

So,

David and Tony, please.

So thanks, Simon. On the clinical trial side, I mean, there has been some reduction in funding from the federal government to different investigators and different clinical trial networks. That hasn't specifically affected us. It has had some impact across pediatric studies that have been going on. And obviously we're working with the community to do what we can there. But there's been no direct impact on GSK or Veev. I think on the PrEP market, I mean, through Q1, it's definitely continued the trend. We're very pleased with the performance of Aptitude, as I said in my remarks, over 21,000 patients now on Aptitude. And, you know, we continue to build this market and we know that it firstly it is an underdeveloped market. Only a third of Americans that could potentially benefit from PrEP are getting PrEP. So there's a huge market development opportunity and we recognize obviously competition would go up in the second half of the year. But I think that competition could help expand the market. And there's definitely an opportunity to switch more of the oral patients into long acting because we know that the persistence and therefore the efficacy is much greater. And we're very pleased to have two real world evidence studies at CROI that I think demonstrated that very clearly in the US and Brazil with the pillar and in PrEP studies that showed 100 percent efficacy, but importantly, very strong long assistance. So it's always work in progress and it's a big change for sexual health clinics and physicians to move from oral PrEP to long acting PrEP. And there's set up and a whole number of more complex administrative procedures, but progressing well.

Great. Tony, coming?

Yeah, just on Kamala Pixon and Simon, I'm not going to disclose what we set as the clinically significant baselines for the CARM studies, other than to say that both studies were designed with an objective of showing a clinically significant effect on cough. So, yeah, COM1 will read out this year, COM2 will read out next year. And of course, we won't be disclosing the broader data across those two studies until we pool them, as is typical for our Phase 3 studies. Just a quick reminder for everyone about why we're interested in Kamala Pixon. This is a molecule whose selectivity profile is many orders of magnitude in excess of related agents. And Simon, to pick up on that, that is very clearly seen in the SOOTH study in which the taste disturbance, which has been a challenge for others, was tenfold lower than that for comparator agents. Just a quick reminder about SOOTH for you. That was a Phase 2 study looking at individuals with 25 coughs per hour. And what we were able to show with Kamala Pixon in that study of both the 50 and 200 milligram doses, that a BID regimen achieved a 34% placebo adjusted reduction and a 24 hour cough frequency. Great.

Thank you. Couple more.

Next question comes from Rajan Sharma from Goldman Sachs.

Hi, thanks for taking my question. Just a couple left, actually. Just ahead of the Blen Rep. Doofa, have you had any interactions with the agency on the potential REMS requirement? And if not, could you potentially just talk to your base case assumption for REMS and how potential scenarios here could influence uptake? And then secondly, just one on capital allocation priorities. Just given that valuations are significantly lower than perhaps a year or so ago, is there a potential for you to be more active on the BD front or is the macro backdrop likely to be a limiting factor?

Very quickly, you're absolutely right. Our appetite for BD remains high. We think there may be some opportunities in this environment. Obviously, we have to be cautious about assumptions on the macro, but that's a question of discipline and returns. But we continue to be busy reviewing and connecting. So that's still definitely a priority for us. On the sort of scale and pace of what you've seen us doing, we're pleased to get IDRX away, but certainly a key priority in capital allocation going forward. Luke, I wonder whether, well, actually, let's go to Tony first just in terms of FDA. But we're not going to get ahead of ourselves on that, considering it's not very far away. But on your comments on REMS and Luke, maybe you could just say very briefly how you see that in terms of uptake, because I know it's something you really want to invest the time in getting right.

Yeah, I might just bridge that, Luke, with the UK approval that we've got. Obviously, our regulatory interactions are confidential, so I'm not going to get into the details of those. But it's probably worthwhile stressing that, as I'm sure you're aware, the REMS are not uncommon for new oncology medicines. You have, for example, for Herceptin, the need for cardiac scans, for Inher2, the management of interstitial lung disease, and Doxorobicin cardiomyopathy. So within that, it's, I think, useful to take a look at the UK approval, which requires eye examination for each of the first four doses associated with BlenRep. I'll let Luke speak to that and the opportunity for us to set up relationships with high street providers to complete that. I won't repeat what I said earlier, but the important point is really an understanding of the data in terms of efficacy. And resolution of side effects and their severity in the ocular event.

Sure. Thanks, Charlie. I mean, REMS are obviously something that is familiar to hemoncologists. There's a number of agents used in multiple myeloma that have REMS. I won't break down our assumptions on various REM designs, but I think common sense would say that the less burdensome are more supportive versus the more complicated. But we're spending a lot of time and let's go back to my earlier point, which is it's really about supporting the physicians. We understand a lot more about the dosing of this product and dose holes, et cetera. So the behavior of the product and how the ocular dimension can be managed through dose holes and really accessing that overall survival is an important component. We're also spending a lot of time on the nuts and bolts of how do patients go through the system? How do you make it as easy as possible for hemoncologists when they've got that patient in front of them who's just progressed on their turn of the map? How do you make it as easy as possible that they can put their practice machinery in place in a community setting to get that patient on the BlendRep? We've also looked at a lot of things like collaborations with optometry groups. We know that 90% of patients in the US or potential patients in the US with multiple myeloma live within half an hour of an eye care professional, which is not surprising because most of them obviously the older need some form of glasses like probably a lot of people on this call. So again, we're being very thoughtful about how we navigate that. And I think that's all we can say at this point beyond what Tony has covered with the UK.

Brilliant. Thanks. And for the reference to our aging profile, time for one more last question, I think, Konstantin. Yes, that's

correct. Last question, please, comes from Sarita Kapila from Morgan Stanley.

Hi, thanks for taking my questions. Just a quick one from me on your long term HIV strategy. Do you have any plans to develop longer acting auras as we've seen from some of your competitors? And if these long acting auras are successful, how do you see that impacting your competitive positioning given the double down on injectable pipeline? Thank you. Thanks.

Great. Thanks for the question. I think we are primarily focused on generating longer acting injectables. I'm very pleased with the progress with Cabinuvra, which obviously is the first mover in long acting injectable treatment. And, you know, great to see the growing momentum there, both in the US and Europe. And we are focused around taking that forward with both four month options and then potentially longer options, six months and so forth. I'm very excited with the data we presented at CROI on 1A4, which really showed rapid and anti viral activity and very importantly, a very broad resistance profile. We'll have more to say on that next year, but I think we're getting increasingly excited about 1A4 as being a significant potential medicine in terms of the weekly auras and so forth. I mean, we're obviously monitoring that. I think they will likely largely cannibalize daily auras. And we'll have to see how that goes. There's different views and different levels of market research on patient preference and compliance and so forth. But our focus at this point is really building on the first mover long acting treatment advantage we have. And we see very clear patient preference to go there.

Great. So thanks, David, and thank you everyone for joining the call. We are only at Q1, but it's great to have a strong start for GSK. We're very much on track to deliver our 2025 outlooks, despite the weather, with strong growth in our biggest business in specialty medicines. And of course, most importantly, really exciting continued pipeline progress. So we look forward to catching up with you in coming days and months. Thanks for joining the call.