Good afternoon, ladies and gentlemen, and welcome to the Analyst Call on the GSK Second Quarter 2021 Results. I will now hand you over to Iain Mackay, CFO, who will introduce today’s session.

Good morning, and good afternoon. Thank you for joining us for our second quarter 2021 results, which were issued earlier today. You should have received our press release and can view presentation on GSK’s website. For those who are not able to view the webcast slides that accompany today’s call are located on the Investors section of the GSK website. Before we begin, please refer to Slide 2 of our presentation, for our cautionary statements. Our speakers today are Emma Walmsley, Luke Miels, Deborah Waterhouse, Dr. Hal Barron, Brian McNamara and myself, Iain Mackay. Joining us for the Q&A portion of the call will be Roger Connor and David Redfern. We request that you ask only a maximum of two questions so that everyone has a chance to participate. Our presentation will last for approximately 30 minutes in order to maximize the opportunity for questions. And with that, I’ll hand the call over to Emma.

Thank you, Iain, and a very warm welcome to you all. We’re pleased to report a strong financial performance and continued progress against our strategic priorities this quarter. Second quarter sales and adjusted EPS were up 15% and 71% respectively at CER. These excellent results were driven by a combination of strong double-digit growth in new and specialty pharma products, a significant increase in vaccine sales, reflecting both an improving picture for vaccination rates and the major sales contribution from a pandemic adjuvant, good growth in consumer healthcare with double-digit growth in six of the nine power brands and – discipline in control of costs. As expected the quarter did benefit from a favorable comparison to the second quarter last year, which was heavily disrupted by the pandemic. And while further disruption cannot be ruled out, we are seeing positive momentum, which we expect to continue through the second half of the year. Assuming a second half backdrop of improving demand for adult vaccinations and normalizing health and consumer trends in key markets, we believe we are likely to deliver adjusted EPS at the better end of our guidance. I just want to remind you that this guidance excludes any contribution from COVID-19 solutions, which we expect to add between 4% and 6% to our adjusted EPS in 2021. Alongside financial performance, we continue to make good progress in R&D and our strategic delivery among our key assets, we completed the filing of long-acting cabotegravir for prevention of HIV. And we announced positive headline results for all five Phase 3 studies of our promising specialty medicine daprodustat. Very importantly, we also continued to strengthen the pipeline. This quarter securing its three exciting new collaborations in HIV, immuno-oncology and immuno-neurology. And lastly, this quarter also saw us layout our new growth…

Thanks, Emma. So we continue to make progress on commercial execution and competitiveness in the quarter against the complicated external environment due to COVID. The strong end market performance are highlighted in the recent quarters for products such as Trelegy, Nucala, and Benlysta is continued driving growth of new and specialty pharma products at 25% in the second quarter and 14% in the half year. We also saw a good recovery in the quarter in Meningitis and established vaccines. So today, I want to focus my remarks on the performance and growth prospects for Shingrix an oncology performance – excuse me. For Shingrix, our confidence in recovery has been tied to the prioritization and successful rollout of COVID-19 mass vaccination, particularly in the U.S. Underlying trends illustrate that Shingrix volumes are expanding as we move into the second half of year. Overall, despite the slower rate of recovery in ex-U.S. market, we anticipate a strong path to global performance from Shingrix, with the potential for slight growth in sales on a full year basis. In the U.S., with nearly 80% of adults aged 50 plus now fully vaccinated for COVID. We’ve now seen the related increase in weekly NBRx volumes, which have grown 73% since the start of quarter two. In the coming months, it’s going to be important for the recovery of Shingrix in the U.S., as they’re updated research shows that around half of those eligible to receive Shingrix have indicated that they expect to get it within one to three months following the completion of their pandemic vaccine series. We think implementing activities to drive this recovery with a comprehensive multi-channel DTC campaign, and by focusing on maximum and relations with U.S. retailers, particularly as we focus on the flu vaccination season, where adult vaccinations become increasingly…

Thank you, Luke. Second quarter HIV sales rebound is strongly growing by 14% and more than reversing the 11% decline that we report in Q1 due to COVID impacts and a strong 2020 comparator. Growth in the first half of the year was 1%. Strong commercial execution continues to drive the performance of Dovato particularly in the switch market in the U.S. and Europe. Dovato and Juluca are on track to deliver £1 billion in sales this year. Our recently launched innovative medicines including Rukobia now accounts more than 25% of our total sales. Highlight this quarter was the market share of dolutegravir regimens in Europe, which for the first time exceeded 30% driven by Dovato share continued to hope them in the U.S. Turning to our portfolio of long-acting injectables, in January, we received FDA approval for Cabenuva the world’s first long-acting injectable treatment for HIV. It is also approved in Europe under the brand name of Vocabria and dosing every two months. We anticipate the approval of two monthly dosing in the U.S. by year end and launch in early 2022. At least signals are positive with strong brand recognition from people living with HIV and high levels of position attendance that’s all that for launch meetings, which we believe will translate into increasing intent to prescribe. As if any new class of medicine Cabenuva will take time to build. And furthermore, the COVID backdrop is significantly constraining switch activity, particularly where a patient needs to visit the physician’s office. We’re confident about its potential to transform the HIV treatment paradigm and with an anticipated five-year headstart of the competitors, we expect Cabenuva to capture a leading share of a long-acting treatment market that could reach £4 billion to £5 billion by 2030. This quarter, we also made…

Thanks, Deborah. I’m going to provide a short update on some recent news flow since the June event and highlight some of the upcoming pipeline milestones over the next 18 months. Starting with daprodustat, we recently announced positive headlines results from each of the five trials in the ASCEND clinical program. As a reminder, the ASCEND program recruited over 8,000 patients from both the dialysis and non-dialysis populations. And it was designed to demonstrate the safety and efficacy of daprodustat is a novel oral treatment for patients with anemia due to chronic kidney disease. We’re very pleased with the results from the ASCEND-ND and ASCEND-D studies, which met the co-primary end points on both safety and efficacy. Daprodustat demonstrated an improvement in hemoglobin levels on untreated patients and maintain hemoglobin levels in patients previously treated with an erythropoietin stimulating agent, the standard treatment option in patients with anemia, chronic kidney disease. Importantly, the two cardiovascular outcomes study ASCEND-ND in non-dialysis and ASCEND-D for dialysis patients both demonstrated that daprodustat with non-inferior one compared with erythropoietin stimulating agent in the risk of major adverse cardiac events or MACE. Additional analyses are ongoing and we aim to present these data at a medical conference later this year. Moving to business development, as I highlighted in June, our strategy has been to leverage business development to augment our organic pipeline and we’ve made some recent progress on this with three deals, which I’ll cover briefly now. First is our global collaboration with Alector for two clinical stage first-in-class monoclonal antibodies targeting sortilin for neurodegenerative diseases. This collaboration brings together Alector’s leading immune-neurology expertise with our focus on the science of the immune system and human genetics and proven late-stage drug development capabilities. The lead asset AL001 is currently recruiting a Phase 3 trial…

Thanks, Hal. Now turning to consumer healthcare in Q2. Continuing sales, excluding brands divested and under review were strong, up 7% at constant exchange rates, which included a 2% drag from retailer stocking last year, head of the system’s cut over in North America, which reversed in the following quarter. Our Q2 results were supported by an easier comparator given destocking in the same quarter last year, following the pantry loading in Q1. The two year CAGR removes the distortion from the pandemic and was up 3% in Q2, which would have been up 4%, excluding the impact of the unusually weak cold and flu season. Let me talk specifically about our category performance in the second quarter. In oral health sales increased 12% with a two year CAGR up 5%, demonstrating good execution and successful innovations with Sensodyne in gum health more than offsetting lower growth in denture care. Pain relief saw Q2 sales up 13% and delivered a good two year CAGR up 5%. In vitamins, minerals and supplements, sales declined 6% as we cycle the demand spike in the prior year. Although the two year CAGR was up 6%, including partially – particularly good growth in Centrum, Emergency and Caltrate. Digestive health and other sales were up 3% in the quarter with a flat two year CAGR. Performance in this category was mixed with strong performance of smokers’ health products and digestive health brands, but continued weakness in brands more dependent on impulse purchase, such as Chapstick. Respiratory sales increased 6% in the quarter and the two year CAGR was down 3%. This reflected very different results in the two sub categories, with strong allergy performance and continued weakness in cold and flu. Don’t forget that given seasonality, Q2 is a smaller quarter for the cold and…

Thanks, Brian. As I cover the financials references to growth at constant exchange rates, unless stated otherwise. On Slide 18 is a summary of the Group’s results for Q2 and the half year. In Q2 turnover was £8.1 billion up 15% and adjusted operating profit was £2.2 billion up 43%. Total earnings per share was 27.9p down 28%, while adjusted earnings per share was 28.1p up 71%. In year-to-date, turnover was £15.5 billion down 1% and adjusted operating profit was £4 billion up to 3%. Total earnings per share was 49.4p down 27% and adjusted earnings per share was 51p up 2%. We generated free cash flow of £313 million in year-to-date in line with the expectations. On currency, there was a headwind of 9% on sales and 25% on adjusted EPS. In particular, due to the strengthening of sterling against the U.S. dollar relative to the second quarter of 2020. Slide 19 summarizes the reconciliation of our total to adjusted results. The adjusting items of note for the quarter wouldn’t disposals, significant legal and other, which reflected a £325 million tax credit due to significant post of revaluation of deferred tax assets in the UK, resulting from the Q2 enactment of the 2021 UK finance bill. My comments from here onwards are an adjusted results unless stated otherwise. Key drivers of revenue and profits for the Group in the second quarter compared to the prior year or set items Slide 20. Revenues grew 15% overall. Excluding revenues from our COVID solutions, sales were up 11%. The pandemic adjuvant sales of £ 258 million, represent delivering around two-thirds of contracted volumes with U.S. and Canadian. The positive operating leverage from higher sales in the quarter was bolstered by continued focus on cost control and the benefits of restructuring across the…

Thank you. [Operator Instructions] And the first question comes from the line of Andrew Baum, Citi. Go ahead.

Many thanks. One question to Deborah and the second for Hal. So for Deborah translocation inhibitor that you’re about to take into the clinic for HIV. You highlighted it as one of the long-term growth strategies. How confident are you in the freedom to operate on the intellectual property? Given I believe it’s a pro-drug of Merck’s is laughter there, which had a very extensive passenger state. And last time I looked, I couldn’t see much in terms of ongoing activity between you and the USPTO on securing a passion for your compounds. So that’s the first question. Second on Alector, Hal, I understand the interest in progranulin from an FTD point of view, but that’s a relatively modest indication. So my question is how you can thinking about selecting patients in the larger indications Alzheimer’s, Parkinson’s. Given that some of the farrago markers we’ve seen though questionable significance in those indications. Many thanks.

Well, thanks, Andrew. And I think you directed your questions very directly. So Deborah, why don’t you kick off from the now?

Sure. So Andrew, as we talked about the business and best threat date, we have a strong pipeline, which is cool as score has integrate inhibitors, which we believe will form the heart of any two drug regimen, either oral or long acting moving forward. We have a number of products in the pipeline of which we have an RTI, but obviously we have this as well capsid bNAb maturation inhibitor, et cetera. And our plan is to progress all of those medicines, to the point at which we will make choices around, which of them is the strongest moving forward. So that’s what I want to say on where we are today with that pipeline. I think we talked about it in more detail at the BIU, but I guess for us, our objective is to have maximum shots on goal, and also with the help of our Halozyme partnership to be able to deliver for people living with HIV longer and longer acting medicines.

Hal?

Thank you, Andrew, for the question. It’s a good question. The genetics really give us extreme confidence, I think in the FTD progranulin gene deficient patients. And number of diseases, both from the sort of biology of non-progranulin FTD as well as potentially ALS, PD and we know is a lysosomal disease from lots of genetic data and other sources. And even Alzheimer’s has been – there’s been some genetics suggesting that progranulin maybe playing a role. So that that’s why we’re excited, of course, neurodegeneration is a massive unmet medical need, where the number of patients with these terrible diseases is growing in the treatment options are limited. So we’re very excited about this. You point out that, that in drug development for ALS to some extent, more so for PD and a lot very clear, and AD that the Phase 2 surrogates haven’t been as compelling as like them to be. I think there’s a lot of opportunity using genetics to identify subgroups. We’re exploring a lot of different markers of lysosomal function of immune activation, imaging data can also help and other biomarkers like, NFT and other sort of neuro markers of degeneration are being explored. And we’re hoping to feel the advances over the next few years to enable some of those to be used for go-no-go criteria. But I think to really be specific, I think it’s the massive unmet medical needs that genetics and our confidence that with stratification variables in these biomarkers that are emerging, we’ll be able to make informed decisions, when we progress these things through Phase 2.

Thanks, Hal. Next question, please.

Thank you. The next question is from the line of [indiscernible] Please go ahead.

Afternoon, everyone. Thanks for the questions. I got two as well. First one on the pipeline and secondly, on the opportunities of COVID-19. Just on the pipeline on daprodustat, obviously a less than straightforward advisory committee meeting for after and lots of these step. I mean, can you believe in – can you come – you can maybe comment, if you believe you’ve got the right dosing to reduce the risk of any of dose – any inbounds in the strong revenue those in your trials, and does your – do the issues that AstraZeneca faced in the outcome in any way change our commercial plans, given your lack of a renal franchise. And then secondly, on COVID 19 solutions, initially, I was under the impression it was non-for-profit, but clearly a strong contribution for the quarter. Could you maybe help us understand the large opportunity that you could have? Because obviously I think the last count Sanofi had signed up 2 billion doses for 2021, 2022. So any help here with respect to the doses about 60 million relate to could potentially help us forecast the strong growth potential in 2022 and beyond. Thank you.

Thanks. Well, I think there’s a lot of questions across the industry about the outlook for the COVID market in 2022 and beyond. But welcome to Roger in a moment, the comments on where we’re at and how we see things evolving, but you’re obviously right, that we also depend on our partners supply even more than our own. Let’s first come to how on that for dosing and I think it’d be good Luke as well, if you would like to make some comments to doing – prove in commercial momentum more generally on how you see plans forward, and approach commercial too, but help us then lose them, Roger.

Yes, thanks for the question. I’m not going to comment too much on the Roxa AdCom. But let me just say that we’re very proud of the program we ran, it’s a very robust program had over 8,000 subjects treated for up to almost four years, two and three quarter years in a variety of patients, as you know, dialysis, non-dialysis, incident dialysis, patient trials. Well, we look to quality of life, et cetera, et cetera. This study is really very robust, but also because these were single trials where they were powered for the ascend and descend a ND for non-inferior of mace. And we’ve looked at the primary end point, we haven’t looked at all the - both on safety and efficacy, but we haven’t done all the subgroup analysis you want. You mentioned, but we will be doing that later and hopefully presenting that at a major medical meeting, ideally later this year. What I can say is that, the hemoglobin targets that we were pursuing, as well as the interactions with regulators, give us a fair amount of confidence that we’ve really designed what we think is a very large, simple, but robust program, and gives us a clear understanding of both the safety and efficacy of the drug.

Luke?

Yes, I think from a commercial perspective, I hope the results that you’ve seen today give you confidence in the evidence that we can commercialize a diversity of the specialty care products. And what I think a competitive segment, I think from a forecasting point of view, it’s still remains quite dynamic. It’s certainly radically different from what it was, 12 months ago, in terms of our assumptions. But, yeah, we’re quite excited about this in terms of COVID assets and commercialization. I mean, so if you had the vaccines component that we’ve tried to map, um, you sort of just trying to deal with European community for up to 220,000 doses. Just for clarity that’s 16 countries within the EDC, a part of that framework. And they have until between now and July, 2022 to purchase that. Just before this call, we had another contract come through from another government, and there’s another attractive order that came through on Friday. So we started to make progress there with sotrovimab.

Roger, would you like to talk about the vaccines.

Yes, yes, certainly. Thanks for the question. I think on the adjuvant partnerships, what we’ve seen this corridor or contracted volumes that we haven’t placed between the U.S. and Canada, but the represent about two-thirds of that overall expected demand for this – for this year. I think it shows the strength of the adjuvant platform likely actually, first of all, we contracted separately on this and government understand that the occupant isn’t just for COVID-19, the argument can be held and then use for future pandemics as well, whether that be a flu or, or for further COVID places. There’s optionality in this platform from a pandemic preparedness perspective, there’s two variables, I’d say that will determine a field’s going post 2021. Emma mentioned that, we have to be able to mark this up with oxygen demand, oxygen supply going forward. So whatever those volumes are, will be a key variable. And then secondly, we’re talking to governments and I write in pandemic preparedness and potential use of the occupant as well. So those discussions could play out. So someone certainly there’s a difficult to say, but there is certainly a lot of activity going on. And I think governments are realizing that the positive nature of a stock buildup as create in particular, which were meant some governments had in place before this pandemic as well. And we’ll just continue to update you as those discussions with governments conclude.

I think more medium term as well. I mean, it is worth remembering the – rather alarming statistics that only 13% of the world is currently doubly vaccinated. There is, as you will know, an ongoing debate around what the meeting term profile is for a booster market or not. And as you know, beyond our current adjuvant to partnerships, we’re very involved in the mRNA platform too. We’ll continue to keep you updates on all of that, but let me reiterate, none of this is in either this year’s guidance nor indeed in the outlooks that we shared with you in June. Next question, please.

Thank you. The next question from the line of Laura Sutcliffe of UBS. Please go ahead.

Thank you. Firstly, a more specific question on the size of the opportunity for Deborah. I think you mentioned an unrisky dose peak sales range of £0.5 billion to £1 billion back in June. Is that book-ended by using dialysis and no unknown biases or there are some scenarios at this point, where the peak sale could be greater than that £1 billion. And then secondly, could you maybe just give us your thoughts on combination opportunities for your older adult RSV vaccine?

Yes. So let’s go to Hal, please. And I think Laura inset – well, inset during his remarks that we would bring you an updated review once we’ve got more published data, but also on the outlet for dapro. And just to refer you to what Luke just said, the assumptions on the environment obviously shifts according to compactors situations and still today unclear outcomes there, as well as our own data which is across dialysis and non-dialysis. You’ll get an update on that more later in the year. But Hal, do you want to – I don’t know if you want to add any further comments on either daprodustat, more specifically on combo possibilities for our exciting RSV pipeline.

Maybe I’m not totally understanding the question, but is it combination meaning the adjuvant plus depreciation, is that, Laura, is that what you meant by combinations or do you mean multiple vaccines combined? I didn’t quite understand the question. Maybe she’s gone. I’ll assume it’s the combination, meaning why we’ve decided to use an adjuvant plus the pre-fusion protein, if that’s – but what you think the question. I think, Laura, when we did the Phase 2 study, we looked at the pre-fusion protein alone and with various adjuvants and various doses. And the summary of the data was a lot of complicated data, but the bottom line, I think is that when you look at the cell immune – cell mediated immunity, the pre-F specific CD-4 positive cells, you can see that in the elderly, when you give the adjuvant, the TSO1, you can see a very nice bump in the CD – immune cells, which actually elevates the level. That’s pretty close to what you see in young adults. And we think anomaly are – is a robust B-cell response, which we saw actually both with the unagitated and agitated components. This T-cell immune response we think is very important, possibly for efficacy as well as duration. And so that’s why we decided to combine it with AS01, the same adjuvant that’s used with Shingrix, which as you can see in the elderly is particularly effective, then has long duration. So that was why we went ahead as opposed to others with an adjuvant approach with the pre-fusion protein.

Thanks. Next question, please.

Thank you. The next question is from the line of Jo Walton of Credit Suisse. Please go ahead.

Thank you. I wonder if I could ask Luke a little bit more about his expectations for Shingrix in the second half of this year. There’s clearly very little progress in the ex-U.S. sales overall in the first half of the year. So can you tell us a little bit more about your confidence in the second half, which additional countries you can go into, how the pricing is forming in that – in those new countries, now that you are unconstrained in supply. And can you just give us some idea of your assumptions on use of say a third dosage versus the ability to put your Shingrix vaccine in the other arm when someone goes to get a flu vaccine around September time? And my second question would be, again, probably to Luke on the marketing side, you were down 15% on your marketing spend in the first quarter, up 5% in the second quarter. Given what we’ve learned about ability to do more digital, et cetera, going forward. Can you give us some help as to what you think a reasonable rate of CER marketing growth should be over the next year or so? Thank you.

Luke?

Thanks, Emma. So on the second one, I mean, it’s interesting, people were out of the field not spending or traveling. If we look at face-to-face activity now in Europe and the U.S. with the exception of oncology, which is a bit lower where it’s sort of 80% to 85% pre-COVID levels. If you add in a non face-to-face digital, the total activity is actually higher than that. So in terms of expenditure, we’ll continue to allocate it to where we can drive the top line and where we see a good return. So I think the trends that you’re seeing historical are probably a better indicator than quarter one and quarter two. In terms of Shingrix, it’s really, really interesting. We track these as you can imagine, very, very closely. And it’s a consistent pattern where you see countries vigorously pursue adult vaccination, it’s highly disruptive to Shingrix vaccination. The good thing is those patterns are consistent. So Germany, we’re now seeing more than 80% of the 60-plus year olds, which is the population where it’s reimbursed are now covered with COVID. And we saw the beginnings of a rebound in June in Germany of Shingrix. In China, the emphasis is still on government vaccination centers deploying COVID vaccines. So we continue to see that disruption. In terms of other markets, we’re also seeing that disruption. So Hong Kong Australia, for example, where we’ve just launched, they’re obviously at the same point. But we have other launches in Spain, in Italy and the UK, in broader populations, but also subpopulations. In terms of pricing, we’re seeing that level of holdup. Now sometimes when we go into these markets, we go in with immunocompromised population first, because we can get the most attractive price at that point. And right now we can use all the volume in those settings. So I think for the second half we remain confident, we’ll see a collective response in Shingrix. In terms of boosters, we don’t assume a booster this year. And it’s interesting when you look at the market research in terms of people’s intention for vaccines, we’ve covered the 50% on the slide, but also if you ask them relative to other vaccines, it’s significantly higher than pneumonia and ptosis and other options for adults. And second only to flu in terms of future intention to get the vaccine. I think there may be some vaccine fatigue on the part of adults, but again, everything that we’re seeing indicates that the second half will be as expected.

Lovely Jo, as well on – I mean, the guidance is that it is possible. But as Luke said, the experience would be that people, there’s a bit of sort of just a human instinctive that people would rather leave it for a few months, but we have the stats on that and we are running carotid studied as well. So that should equip as well. Fundamentally, this is a disease that one in three people get, we know the underlying demand is good. And as Luke said, we’re being able to maintain economics and confident in the outlet that we laid out for the five years. Clearly, with lifecycle innovation, which you also saw some recent announcements on in terms of expansion of travel. So next question, please.

Thank you. The next question is from the line of James Gordon of JPMorgan. Please go ahead.

Hello, James Gordon, JPMorgan. Thanks for taking the two questions. First question was on the adult RSV vaccine competition. So potentially to be the biggest product in the pipeline, but I saw a play that just announced that in their Phase 2 challenge study that 100% efficacy in adults. And they also said, they’re going to kick off this. I experienced September this year or they could report with early Q1 next year. So my question is, what does that mean for GSK, they would have adult program. Does the Pfizer data suggests their product could be at least as effective as yours or do we need to be careful and try to compare quite different end points? And could you do the same thing? Could you accelerate your Phase 3 and data the same sort of timelines where the reasons you might take a bit longer? And the second question was just a clarification on daprodustat, as already mentioned – had a tough outcome, although they had a non-inferiority headline on the safety, the point estimate looked worse than stage and that didn’t go very well at the outcome. But it sounds like you’re very confident in your product. So can you give us some – because you also differentiated from what and then you’ll point estimate or may safety does actually better?

Hal, why don’t you take both of those and Roger, if you want to add anything on the broader RSV perspective, then come back to you. Hal?

Thanks, James. Look, I’m not going to make too many comments on the announcement of Pfizer, but let me just highlight a few things about what we know about our project and why we’re so excited about it. First of all, just to anchor everyone, of course, RSV in older adults is an enormous unmet medical need with just in the United States alone over a 180,000 people hospitalized and as many as 14,000 of those unfortunately die. Our Phase 2, as I was alluding to this earlier, really does show pretty robust B-cell response with neutralizing titers that are very comfortably in the range where we expect a significant efficacy. I’m personally very pleased that this data that the pre-fusion antigen is the right one as evidenced by our data as well as now with Pfizer. So that’s exciting. It’s also important to remember that our program has this AS01 adjuvant, which I explained earlier provides this T-cell immune response, which we think will actually increase efficacy like we saw with RSV, but also maybe potentially duration, et cetera. So it’s differentiated vaccine combination, if you will, with the pre-op antigen, as well as the very effective proprietary AS01 adjuvant. I think it’s also important if I understood it correctly, that, that, while we are very confident that the immune response would be mounted effectively in the 18 to 50-year olds, this is again older adults is an older population where again we need to be ensuring we have the most robust immune response to protect them as their immune systems are different. And as I said earlier, the T-cell immune response wasn’t normal than an unadjuvanted RSV vaccine, and that’s why we chose to use the adjuvant because the T-cell response became much closer, actually almost identical to…

Thank you, Hal. Next question, please.

Thank you. The next question is from the line of Kerry Holford of Berenberg. Please go ahead.

Thank you. Two questions, please. So firstly on the COVID antibody. I wonder if you’re willing to give us an idea or the effective price per dose that you’ve secured for the dose orders you’ve secured to date and over what timeframe we should expect that orders to be delivered to that. And then on the flu vaccine, following with you’ve been to ship over 50 million doses in the U.S. and then that conclude that the sales of flu vaccines this year should likely exceed 2020, I think which is around $730 million. Is that fair? Thank you.

Thanks, Kerry. Well, I’m going to ask – because I think he should have a question Iain to talk about or the flu outlet – we’ll come back to Luke on the timing. I would say the short answer to, are we going to give you the precise pricing of our contracts will be no. But let’s go to Iain first and then come over to Luke.

Luke, don’t feel compel to get.

Obviously, and Brian is available as well.

So carry on a volume basis, we would expect numbers to be probably similar to last year. However, you’ll recall from our commentary in the fourth quarter last year results, which we didn’t in early February, that we had a very significant IRR adjustment in flu last year. And so net netting out that, that IRR adjustment, which we clearly wouldn’t see the benefit of again, I think volumes would be expect to be broadly similar, but in dollar terms or Sterling terms rather, and will be slightly less.

Yes. And I would say that in the outlook of the 4% to 6% beyond guidance EPS that include the recent contracts.

It doesn’t beat, yes.

Yes, it does, so that’s worth noting. Luke, you mentioned it before. Is there anything else you want to add on the delivery?

Yes. Yes. I think what we now need to do, we’ve got this overarching contract. We need to approach these 16 countries, which include all of the major European countries and sign up volumes. And we’ve also got a number of other countries outside Europe that we’ve got contracts for. So I’m hoping in Q3, we can give you a lot more granularity, because we’ll have those in hand. In terms of pricing, the only price that was given publicly as 2,100 VAC in the U.S. where we’re selling a small number commercially. For Europe, you should just assume it’s in the range of industry pricing.

Next question, please.

Thank you. Next question from the line of Geoff Porges of SVB Leerink. Please go ahead.

Thank you very much. And a couple of questions for how – our first just on the IO portfolio, you’ve highlighted the CD26 – CD226, sorry, portfolio many times. I’m just wondering if you could give us a sense of when we could see the first clinical proof of concept for your combinations, the different combinations there for that whole strategy. And then secondly, on again daprodustat, do you believe that we should expect cloth labeling for the daprodustat for infection risk, thrombosis risk and seizure risk, given the imbalances seen in your competitor’s trials? As you know, the FDA has been extraordinarily cautious about labeling in the CKD population for the ESA. And so would that be prudent on our part? Thanks.

Hal?

Thanks, Geoff. Yes. Thanks, Geoff. The IO portfolio is actually quite robust now. And the CD226 axis, I think is well covered with both the now anti-TIGIT from iTeos we have the CD96 inhibitor is advanced in our collaboration with 23 new and the – for this behind, but also exciting as the anti-PVRIG, which should get into the clinic next year was a deal with surface oncology recently. All of those of course can be combined with each other as well as with dostarlimab. So the four drug combos are quite complicated and there’ll be a lot of dose ranging that’s needed indication ranging if you will. And we will be getting data from combinations with CD96 and dostarlimab first. So that will be the first readout that should occur in 2022. We should be able to get some PVRIG data probably in 2022 as well. The TIGIT combinations with dostarlimab we’ll be seeing in 2022, hopefully some data. It all of course depends on how robust the data is and what the – whether we see activity at various doses. The triplet will take a little longer just because we have to get through all the dose ranging and safety, but that should come following the observation of proof of concepts with those combinations. So exciting opportunity we think to take the field beyond the PD-1 era and enter into a CD226 era, possibly a doublet or maybe even a triplet if the cards fall appropriately. We can make a triplet that would be profoundly beneficial for patients if that was the case. So I’m excited about that opportunity. In terms of that, but I really don’t want to comment on discussions that we haven’t yet even started with regulators. The data that I mentioned that we are very excited by was the primary end point. We haven’t done any of the subgroup analyses and other sensitivity and analyses that are going to be of course needed. We’ll be doing those very soon. We should have that data and hopefully to be able to present that later this year, of course, then that’s followed by discussions with regulators digestion of the classes you say, and I think it would be premature to have any speculation on what anyone else’s labels might show for sure. And ours we’ll of course follow the data. Thanks for the question, Geoff.

Thanks, Hal. Next question, please.

Thank you. Next question is from the line off Keyur Parekh of Goldman Sachs. Please go ahead.

Good afternoon. Two questions, please. One on commercial opportunity for Blenrep. Luke, I noticed that Bristol kind of reported first quarter revenues for the BCMA CAR-T of $24 million. That’s roughly similar to the $21 million Sterling you reported for Blenrep. So just give us a sense for where kind of Bristol is taking shed and how confident you are for growth of Blenrep, even without the additional studies kind of reading out. And then secondly, for Brian, Brian, congratulations on kind of the CEO designate, not surprising at all, but your slide talks about e-commerce being 7% of sales for the consumer healthcare business up 30% for the quarter. Just wondering if you can kind of give us a sense for how that 7% tax relative to your peer group work was this corresponding number last year. So just give us a sense for how big you think e-commerce might be for the Glaxo consumer health business going forward. Thank you.

Thanks, Keyur. So Luke first.

So I mean, I think, Keyur, I’ll just lay this out. I mean, right now we have about a quarter of patients in the U.S. who are fifth line in terms of patients on drug, but about a third of them are now – about a quarter of fifth line, but the rest are six, seventh lines, but one in three new patients coming on a fifth line. So we’re starting to move up there. I think there has been a bit of pressure in that fourth line setting, it’s a relatively small number of patients. There’s a lot of competition for them with studies such as teclistamab that bispecifics. In terms of the CAR-T, I mean, let’s see there’s some ordering patents probably there, again, it’s concentrated in academic centers where we now seeing our growth is in the community, which is a natural progression. I mean, in the end though, we need to address the dosing and this how has that long has a lot of activities to do that, to penetrate the earlier lines of treatment where the vast majority of the opportunity for this product exists. We’re less concerned around – again, I think that’s the thing is in AMD population, and some of the talks around aim and it’s impacting treatment length. So I think we’ve got more work to do to capture those fourth line patients in the community. And we’re working very hard to do it.

Thank you. Brian?

Thanks for the question and thanks for the congratulations also. As you said, our e-commerce has percent of sales is 7% up 30% last year, we were at 6% of sales. We continue to see progression. As far as how that compares to competitors, it really is dependent on – quite dependent on portfolio. If you look across our portfolio, that’s an oral care. We are overdeveloped where we have higher shares in many of our brands online versus offline. In OTC, we’re pretty much in line, but skewed towards, again, being overdeveloped so slightly better than I would say the competitive set. And on VMS actually is an area we’re catching up. So we were underdeveloped on VMS is there’s many more digital native brands in that space. But we’re growing in that area very aggressively. And we’re seeing really good progression in that area. So I continue to believe this is an area that’s going to continue to grow really healthy. We’ve seen a massive shift in these categories to online shopping as part of the behavior that came with the pandemic. And we see that consumer behavior continuing and I feel really great about where we’re at and our capabilities in this area to continue to win in the space.

Thanks, Brian. And I would also like to add my very public congratulations and pride in your appointment.

Thank you, Emma. You got a question along that front.

The other thing I would just overlay it’s not only the brand power on digital. It’s also the geographic mix where, because of our strong presence in consumer in both the U.S. and China, which are very e-commerce friendly regions that also helps drive both our capability and competitiveness on that. Next question, please.

Thank you. Next question is from the line of Emmanuel Papadakis of Deutsche Bank. Please go ahead.

Hi, Emmanuel.

Hi, thank you for taking the question. I’ll make it two for Brian, actually. Okay. First question on margins, please. You reiterate the mid high 20s for the next year, I think. But obviously that as part of the current business, not as a standalone. I know there’s been some discussion of what additional standalone costs you would incur. So any insight you can offer us at this stage in terms of the step down on margins, we’d like to be to see it as a standalone business. And if not now, anything quite that not now when are we likely to get that number. And then maybe a question on your R&D side you report to them as MOONSTONE. Perhaps you could give us some comments on that missed the target – drawn overall. What does that imply of anything to clinical development program for the Zejula? I don’t actually think we do any pivotal or proof of concept based points for the rest of this year or even next, but we just waiting for that zero lung maintenance, but in 2024 of the other things we should be thinking about looking at for what you’re considering. Thank you.

Thanks very much. First of all Brian, do you want to comment on when we will be share?

Yes. As Emma mentioned, we’ll be doing a capital market stay in the first half of next year. We haven’t identified that date yet, but at that time is when we would share much more detail around the business in a lot of areas around our cash flow and our margin progression and included in that would be any of the one-off cost. So you’d expect to hear about that next year before separation.

Thank you. Hal?

Emma, could you just a part of Emmanuel’s question dropped out. Could you just repeat it briefly?

I can repeat it if you can hear me.

Thanks, Emmanuel.

You’re welcome. So its just a question on miss in MOONSTONE. What does that imply for the clinical development and next data points we should be looking for some chemo.

Thank you. That’s what I thought I said. I just want to confirm. You are correct, MOONSTONE has been stopped that I think it’s important to point out MOONSTONE was a single-arm open-label Phase 2 study, where we were looking at response rate. It was in the most difficult patients with ovarian cancer to treat the so-called platinum resistant ovarian cancer patient populations who actually do not very well even with chemo and bevacizumab, but these are second line those who failed bevacizumab. So very resistant population, but was based on some very small numbers of patients that suggested maybe the combination of PD-1 one plus PARP would be beneficial. So we had a very high bar and the study where we looked at the response rates didn’t suggest that it was going to achieve the bar we had. Now, the study that we’re always been more optimistic about because again MOONSTONE was in the treatment setting where frankly PARPs the data for PARP the treatment setting has been varied in terms of efficacy in the maintenance setting is where you really see the benefit and the study that we thought would most definitively identify an opportunity for the combination of a PARP plus B1 was the so-called first clinical, the first trial, which is in as where patients received chemo with the dostarlimab and niraparib first the standard of care platinum-based regimen, and that is enrolling well. And we should see data for that before is the next opportunity to have a direct read through for this synergistic – potential synergistic impact. We are also, as you, as you mentioned, committed to other combinations of niraparib with dostarlimab, we have the Phase 3 Ruby part two section where we’re comparing dostarlimab in combination with niraparib for patients with endometrial cancer. And of course, we have the zest and zeal, both of which could be transformational for patients zero being in the frontline lung cancer setting and investing a novel study designed for patients who are surgically women with breast cancer, who were surgically treated for the intent of cure, but who’s – who have evidenced through tumor measurements in the blood the cell-free DNA from the tumor being evident as a biomarker that we’re using to start treating people to potentially prevent the disease from recurring. So two innovatives and I think exciting trials are that in addition to first we’ll add to hopefully a lot the patient benefit into the lifecycle of niraparib.

Thanks, Hal.

We get time for one more question, and then we’ll wrap it off.

Okay.

If there’s one more question.

Thank you. The next question is from the line of Graham Parry of BOA. Please go ahead.

Okay, great. Thanks for taking the question. Especially on Shingrix, just wondering if you could just help us kind of square the circle of the different commentary so that the guidance is a little cautious, but you’re still talking confidence in strong recovery into age. So are you still expecting a very strong 2022 and then consensus is looking for 25% year-on-year growth. So does that sit within the range of your outcomes internally? And then secondly, just following-up on the question on Pfizer’s RSV vaccine timing that suggest perhaps they might be expecting more RSV events coming this season, if they think they can get to a data readout in Q1. So is it also the case that perhaps the RSV incidents is picking up relative to what you seem to when you originally planned your studies meaning your data could also come earlier. Thank you.

So Hal, come back again to the RSV study and just on Shingrix, yes, we do see a significant step up in 2022. We’re not going to start commenting on versus specific annual guidance on that grand. But Hal, would you like to comment on the RSV study – on RSV?

Yes. Just to reiterate, we – there’s a lot of assumptions that go into determining how long the trial will take. Of course, as I mentioned before, it has a lot to do with sample size. So we’ve – are enrolling 25,000 people that enrollment’s going very well. It does have a lot to do with the number of events, which is actually related to some extent to the treatment effects. And there is some reason to believe that the events might be higher than anticipated based on the fact that in 2020. There was very limited RSV. And sometimes there’s without the prior season immunity, sometimes there’s more clinically significant cases, but again, we’re all estimating these things. And it would be probably more like a class effect if you will, but if there’s more events that’s going to – we’ll be seeing that in any trials and RSV will be obviously unique to us or Pfizer or anybody else. So we just have to wait and see. And of course, anything’s possible, but the idea that maybe there’s more actually because of the 2020 low levels, there is some data suggest that might be the case. We’ll just have to wait and see.

Thank you very much. And with that, everybody, we’ll finish today’s call and look forward to catching up with you in the coming days for those that we don’t get to speak to, I hope whether it’s new or for you get some kind of a bright and look forward to catching up again soon. Thank you. Goodbye.