Good afternoon ladies and gentlemen and welcome to the analyst call on the GSK fourth quarter 2020 results. I will now hand you over to Iain Mackay, Chief Financial Officer who will introduce today’s session.

Good morning and good afternoon. Thank you for joining us for our full year 2020 results, which were issued earlier today. Normally Sarah Elton-Farr, our Director of IR would lead this call, but unfortunately Sarah’s been out ill for a couple of weeks and this is literally her first day back, so she’s in listening mode only today. You should have received our press release and can view the presentation on the GSK website. For those not able to view the webcast slides that accompany today’s call, they’re 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, myself Iain Mackay, Luke Miels, David Redfern, Brian McNamara, and Dr. Hal Barron, with Roger Connor joining us for the Q&A portion of the call. We request that you ask a maximum of two questions so that everyone has a chance to participate. Our presentation will last for approximately 45 minutes, slightly longer than usual to allow time for Hal’s extended fourth quarter R&D update. With that, I’ll hand the call over to Emma.

Thanks Iain. 2020 was an extraordinary year for all of us, another year of strong progress for GSK, and we’re very confident in building on it in 2021 the successful separation in two new companies with strong performance trajectories in 2022 and beyond. 2020 was always planned to be a year of investment in our pipeline and new launches and in preparing to be two companies but we also had to respond rapidly to mobilize through the pandemic, and I’m extremely proud of the agility and resilience our teams have shown in the face of this challenge. We remain firmly on track with all our strategic goals. We delivered strong performance in our growth drivers and disciplined cost control to offset the unexpected impact in vaccines and so delivered our guidance of the year, which was set before the pandemic, with reported sales up 3% CER and earnings down 4% to 115.9p. I’m especially pleased by the strong commercial execution in our new and specialty products with sales of £9.7 billion, now more than half of our pharma business and up 12%, which reflects the impact of the changes we’ve been making to compete more effectively and generate greater share of voice across our growth drivers. You’re going to hear more about this from Luke shortly. Consumer JV integration is substantially complete and separation preparation is progressing very well, delivering efficiency in our support functions, simplifying our site network, and further building world-class brands. We also achieved an important milestone with the launch of our One Development organization in R&D. This is already improving agility, decision-making, and scientific collaboration between pharma and vaccines, as well as the cost base. We’re transforming the pace and delivery on innovation, as Hal will talk to. We had nine major approvals in 2020 and…

Thanks Emma. All the comments I make today will be on a constant currency basis, except if I specify otherwise, and I’ll cover both total and adjusted results. On Slide 8 is a summary of the group’s results for 2020, showing that we delivered within our guidance range. 2020 performance demonstrated continued execution on our strategic objectives. Reported turnover growth was 3%, down 2% on a pro forma basis. Total operating profit was up 15% with total earnings per share up 26%. On an adjusted basis, operating profit was up 2% and declined 3% pro forma, while adjusted EPS was down 4%. I’ll go through the drivers behind these in more detail in a moment. We delivered another good year with regards to free cash flow, generating £5.4 billion. On currency, the strengthening of sterling against the U.S. dollar and weakness in emerging market currencies relative to 2019 resulted in a headwind of 2% on both sales and adjusted earnings per share. Slide 9 summarizes the reconciliation of our total to adjusted results. The main adjusting items [indiscernible] were in disposals, which reflected the disposal of Horlicks and other consumer healthcare brands; in major restructuring, which reflects continued progress on the consumer healthcare integration and separation preparation programs; and in transaction related within which the main contributor was a charge relating to the re-measurement of the contingent consideration liability for Reed Healthcare, including increased forecasts related to strong cabotegravir PrEP data. My comments from here onwards are on adjusted results unless stated otherwise. Slide 10 summarizes the pharmaceuticals business, where overall revenues were in line with expectations with a slight decline, down 1% [indiscernible] 2020. Excluding established pharma, revenue grew 12% in the year, reflecting strong commercial delivery of our new and specialty medicines. Respiratory was up 23% with strong…

Thank you Iain, and hi everyone. 2020 was a transformative year for GSK in terms of our commercial execution capabilities and despite the challenges brought about by the pandemic. During the year, we benefited from a number of important changes to our HCP engagement policies and sales force incentives. In addition, we invested in expanded digital capabilities to complement our traditional detailing approach. The result of these changes was that we were able to compete more effectively in our key markets and to win greater share of voice across key drivers in our portfolio. The momentum we now see behind our new and specialty products is really encouraging and I just wanted to spend a few minutes highlighting some of the important examples. Starting with key respiratory drivers, which you’ll find on Slide 18, Trelegy had a tremendous year with sales up nearly 60% to over £800 million in just its third year on the market. Trelegy continues to lead the inhaler triple category for COPD in the U.S., Europe and Japan, and is growing the overall market. In the U.S., the FDA approval on asthma in September had a hugely galvanizing effect with two-thirds of HCPs recognizing the uniqueness of our dual indication, and we’ve seen prescribing by allergists soar. As a consequence, Trelegy’s market share has continued to build and in fact is now more than double the share of its newest rival and closing on 50%. While we expect asthma to help drive momentum in the U.S., it’s also important to stress that we still have a major opportunity for growth in COPD as little more than a quarter of patients receive triple therapy despite an addressable patient population in which up to two-thirds of sufferers are at risk of exacerbation. If I move to Nucala, we…

Thank you Luke, and hello everyone. The HIV business grew 2% in Q4 and 1% for the year. Within this, we achieved [indiscernible] acceleration in our dolutegravir regimen with growth reaching 4% in the U.S. and 8% in Europe in the fourth quarter. This growing momentum is the result of strong execution from commercial execution behind our two-drug regimen and Dovato in particular. We now have the leading share of voice in the U.S. and Europe, and this helped sales of Dovato and Juluca to more than double in 2020 to over a billion dollars. A key driver for Dovato has been the inclusion in mid-2020 of the TANGO switch data in the U.S. This has helped to drive dolutegravir’s share of the NBRx switch market in the U.S. to approximately 31.5%, well above our TRx share of just over 25%, therefore supporting our growth expectations over the coming year. We have also seen a positive start for Rukobia with more than 300 patients now on this potentially lifesaving therapy. Turning to our injectable portfolio, on January 21 we received FDA approval for Cabenuva, the world’s first long-acting injectable for the treatment of HIV. This follows European approval in December. Cabenuva is the first and only once-monthly regimen shown to have non-inferior efficacy and comparable safety to a daily oral three-drug regimen. For many people infected with HIV, the stigma is a daily reminder of their HIV status; as a result, up to two-thirds express strong interest in a long-acting therapy, and in our pivotal studies nearly all patients preferred Cabenuva. We also see a significant opportunity for cabotegravir in the PrEP setting and will be presenting the detailed superiority data versus daily oral PrEP at CROI next month. We intend to file this product with global regulators in the first half of this year. We believe Cabenuva and cabotegravir for PrEP will both provide significant benefit to patients as well as having blockbuster commercial potential. In summary, we are very confident in the outlook for ViiV. We expect a progressive acceleration in growth underpinned by the continued expansion of the two-drug regimen, mostly with Dovato and the launch of Cabenuva, and in due course cabotegravir in the PrEP setting. With that, I will hand you over to Brian to talk about consumer.

Thanks David. In a year where consumer health has been more relevant than ever, our results today reflect the strength of our portfolio, the benefits from successful integration to date, and our investments in digital and innovation paying off. This has been despite the challenges of the pandemic and the need for more agility than ever in managing through the crisis. I’d like to start by sharing an update on integration. The positive momentum I shared at Q3 results has continued with a number of milestones achieved to date. The commercial integration is now largely complete with the manufacturing integration underway. Ninety-seven percent of Pfizer consumer healthcare revenue is now on our system with 74 markets having transitioned since the start of the pandemic, and 100% of collocations are now complete. At the time of the transaction, we provided synergy and financial guidance for 2022. That remains unchanged. On divestments, we completed transactions in 2020, delivering on our £1 billion proceeds target. The divestments of more than 50 growth-dilutive brands has helped strengthen our portfolio. Our separation program is also on track with work around the future organizational structure and systems separation underway. In 2020, pro forma revenue constant exchange rates, excluding brands divested and under review, grew over 4% supported by healthy brand growth and overall share growth. Our business continued to benefit from the consumer focus on health and wellness, the strength of our brand portfolio, and successful execution. Vitamins, minerals and supplements remains a standout performer with Centrum, Emergen-C and Caltrate all up double digits, and our category performed ahead of the market. We also saw double digit growth in the final quarter in China and in our retained business in India. Ecommerce was strong across all categories, growing around 70% for the year and now at…

Thanks Brian, and good afternoon everyone. Today I’ll spend the next 10 minutes or so summarizing and update what I shared at the JP Morgan Healthcare conference last month and highlighting some of the assets we believe have the potential to be transformational medicines and vaccines. Let me start by reminding you that in July of 2018, I introduced our new R&D approach focused on science, technology and culture. Our goal was and still is to build a high value, sustainable pipeline through a focus on the science related to the immune system and to use human genetics and advanced technologies, such as functional genomics machinery, to help us identify novel targets with a higher probability of success and a robust lifecycle potential. Two and a half years into this new approach, I believe we’ve made significant progress. Across our pipeline, we have seen the benefits of our commitment to immunology and genetics. In oncology, our focus on immunology has resulted in numerous immuno-oncology medicines and several innovative cell therapies being added to our pipeline. Our focus on human genetics and functional genomics has led to the acquisition of Tesaro, the formation of a synthetic lethal research unit, and through business development a growing portfolio of programs and important collaborations. In infectious disease, this has led to a significant number of opportunities across both vaccines and pharmaceuticals, including solutions for the COVID-19 pandemic. Our focus on human genetics and functional genomics has resulted in more than 70% of the targets in research now being genetically validated. We’re also delivering value from our commitment to lifecycle innovation due to closer collaborations between the commercial and R&D organizations. A good example of this is the number of new launches for Nucala that Luke discussed and most recently with the advancement of our…

Thanks Hal. To summarize, 2020 was a year of great progress as we approach separation into two new companies, and we remain fundamentally on track to deliver all our strategic priorities Our pipeline is stronger, our commercial [indiscernible], our cost base leaner, and our confidence higher in our ability to deliver sustainable, long term growth post separation into two companies. In terms of our priorities for the year, we will retail our execution focus on innovation and performance and expect another year of investment behind our pipeline [indiscernible]. We’ll continue to work on optimizing our cost base across the group and setting up the consumer basis as a standalone entity, and with a long-term focus on trust, we’ll work to deliver on our public commitments and maintain our sector-leading ESG performance. All of this aims to support future growth and the significant value creation we expect to deliver with the formation of two new leading companies, each with the opportunity to improve the health of hundreds of millions of people. Finally and very importantly, I’d like to recognize the enormous contribution of our people and all the partners we’ve worked with in 2020 under extraordinary circumstances. Without them, we wouldn’t succeed, and we count on them now as we prepare for our very exciting future. With that, Operator, the team on the line is ready to take questions.

Thank you Emma. Your first question comes from James Gordon of JP Morgan. Please go ahead, you’ve live on the call.

Hello, thanks a lot for taking the questions - James Gordon from JP Morgan. Two questions, please. The first question was about vaccines and the CureVac deal and mRNA vaccines. The release says as well as looking at COVID-19, you’re also going to look at other respiratory vaccines, so could that include something like RSV, for instance? Maybe more generally, how are you thinking about a vaccine in terms of the mRNA space, could you see a lot more competition coming in there? I know at our conference last month, Moderna and BioNTech were talking about going after flu, amongst other diseases, so could mRNA vaccines be a serious strategy [indiscernible] protein-based vaccine business, and it’s also a big opportunity for GSK? That’d be the first question, please. Then the second question was about the EPS growth rebound in 2022. I’ve seen you’ve guided for meaningful improvement in revenues and margins, but the question is how meaningful could the rebound be in 2022? If vaccines rebound and there’s some catch-up and the rest of the business is doing better and opex growth flows, could ’22 be a year of double-digit EPS growth or could ’22 earnings be above ’20 earnings power? How should we think about that, please?

Thank you very much, James. In terms of the CureVac deal, I’m going to ask Roger to comment a bit on how strategically this impacts our portfolio and the enormous opportunity that we see here, and why we think that GSK is very, very well placed, because obviously we were delighted to make the announcement this morning because it allows us to contribute to COVID, which we’re all learning continues to evolve. I think it’s becoming increasingly clear that there’s opportunities both in vaccines endemically but also, as Hal alluded to, in terms of our therapeutic treatments, so it’s very important for that but it’s also additive to the very exciting platforms we’re taking, and we do see this as a second generation mRNA but that can be combined with some of our other platforms. But Roger, I think it would be great to hear from you just a bit about how this fits in more broadly, and then we’ll come back to your guidance question afterwards, James.

Yes James, thanks very much for the question. Specifically on combinations, I think we’ll share more later in the year in terms of our overall pipeline, but it’s obvious that getting access to the COVID second generation is a big opportunity for us. We’d be looking at combinations and certainly looking at the flu asset that you referenced as well as our potential for combination in the future, so more on that coming. I think when you step back and you look at the CureVac relationship, we’re delighted. We’re delighted to add what we just announced today to a very strong strategic relationship already. Bringing together two companies, CureVac with their platform and also with the technical expertise and scale we have got, really we think is going to make a difference. Specifically on the COVID-19 vaccine in this particular deal, this idea of getting multivalent protection, we think is going to be critical, because you’ve seen that data from recent clinical trials certainly shows that the level of protection from some of the licensed vaccines, this could potentially fall as these new variants evolve. mRNA is a proven platform now and it is one that we see as a real strategic strength of ours. Applying it to COVID brings breadth of coverage we think to the multivalent approach, speed of reaction because of the very nature of reprogramming an mRNA vaccine, and we’re also going to be working with CureVac in how we store and distribute this in an optimal way. Just on your broader strategic question around the opportunity threat of the technology, my headline here is it’s an exciting time to be a global leader in vaccines. We feel very well positioned, particularly on mRNA 2 programs which Hal referenced internally, self-amplifying and then also the relationship with CureVac, which is a known replicating mRNA, so we’ve got very strong optionality here as well. We see far more opportunity than risk. Now, we’d never be complacent, but from an mRNA perspective, it [can’t] [ph] be applied to all disease areas, so when we add this, we think it really complements our technology portfolio. When you add it to viral vectors, add it to adjuvant, you add an mRNA play, we’ve got a portfolio, a deck of cards here that we can select from to make sure that we get the best vaccine for each disease that we are developing. You just have to look at our pipeline. You look at our therapeutic hepatitis-B vaccine - it’s an example of combo technology where we think we’ll be able to plug and play some of these for the best vaccines going forward, but we’ll share more of that as we go through the year. But I think headline is, I think we’re very well placed.

Thanks very much, and James, in terms of your guidance question, obviously we’re really pleased with the progress we’re making, and said several times and reiterated several times today that despite the impacts of the pandemic, which we see as short term, there’s absolutely no change to our ambitions and confidence in ’22. We’re going to give you more precision about that in our update for the biopharma group more broadly in terms of growth outlook in the medium term. Iain, I don’t know whether you want to add any more details?

I think we’ll certainly provide lots more detail in terms of what supports our optimism around the outlook for 2022 and beyond, James. I think importantly building blocks here, right - 2020, tough year, but delivered in our guidance range, and as you know, that was informed well before we all started living with the pandemic. 2021, the in-year impact is very much about vaccines. We see the progress in our pharma business and our consumer healthcare business again very much in line with what we saw at this time last year and made great progress in ’20. That will continue through 2021. The work that we’re doing around the cost base, the restructuring the group out of readiness for separating the group all gives me a great deal of confidence around that progress in terms of meaningful growth, in terms of both top line but expanding growth in adjusted EPS from ’22 onwards.

Another thing, because I think Luke cut out from Australia exactly the moment when he was giving precision on the Shingrix outlook, so I’d just repeat what was said, that we really do see the impact on Shingrix being about the deferral of sales. We’ve made great progress in manufacturing capacity, so our expectation is broadly similar volumes in the U.S., recognizing the uncertainty that Iain introduced, but broadly similar volumes in the U.S. with growth weighted more to the second half and more of the contribution from other countries ex-U.S. before we then see, assuming a return to normal health operating systems, some good growth in--good strong growth in ’22. Next question please, while the phones get switched off at this end - apologies. Next question, please.

Thank you, and your next question comes from James Quigley from Morgan Stanley. Please go ahead, you’re live on the call.

Hello, James Quigley from Morgan Stanley. Thanks for taking my questions. For my first question, I’d love to get your thoughts on any of the other levers or mechanisms in order to recognize cash flow to be able to invest in pharma innovation. Clearly the dividend cut is going to unlock some cash uses to invest in, and you guided for the pharma business excluding any divestments, so should we expect some more divestments and some cash realization this year to invest in other areas, starting this year or in 2021, or is that sort of a beyond strategy? Then you now have the CureVac collaboration, the broadly extended collaborations this morning. You’ve got lots of collaborations, as Roger highlighted, in other areas. More broadly, how are you taking the learnings from your vaccines work and looking to apply that into immunology and immuno-oncology and to use mRNA in the broader sense as a therapeutic? Thanks.

Great. In terms of divestments, the short answer is yes. I’ll ask Iain to comment quickly on the [indiscernible] constantly looking at that portfolio and do have further plans this year, but I’ll ask Iain to comment on that and the broader cash flow discipline. I’m very pleased with the progress we’re making overall on operating delivery there, and then I’m going to come to Hal. I mean, this is really the great strategic benefits of the new biopharma company, being focused on driving certain vaccines and specialty and all around the science of immunology, and we are seeing this great convergence and we now have one development organization, so after Iain, let’s come to Hal to talk a bit about how we’re thinking about that with the vaccines and pharma R&D.

Yes, thanks Emma. James, really strong performance from the team this year in terms of free cash flow. Obviously that was a year that was supported by really, really good work by Brian and the team across the tail brands within the consumer healthcare portfolio, reaching--surpassing, in actual fact, their £1 billion net revenues in that regard--proceeds, rather. What continues, as I mentioned in the script, on the established pharma portfolio, where David Redfern and his team continue to work very closely with Luke and where the opportunities are in the right inflection points for divestment from that portfolio, there’s a number of targets that we are working on presently, and we’ll keep you informed in that as we make progress. I think it’d be fair to say that in the pharma space for divestments, 2020 was a somewhat more difficult year from a valuations perspective, and our focus on divestment is doing it for the right reasons at the right valuations. There’s a good focus around that, and we would certainly expect to see proceeds supporting free cash flow as we work through 2021 in that regard. Then beyond that, it just continues to be a really sharp focus on improving our management of working capital, in which we’ve really done a lot of good work over the course of the last two years, but as ever more to be done in that area. Then when you look forward, it’s very much--and we’ll provide a lot more information about this at our biopharma update in June, it’s very much about establishing the right capital structure for each of these two new companies going forward. You will recall from earlier conversations that there is a significant de-leveraging opportunity for GSK on the separation out of the consumer healthcare business, which clearly continues to support our ability to do business development and invest in the strength of our pipeline.

Yes. Hal, over to you on the scientific synergies in immunology.

Yes, thanks. We’re very excited about the advances that mRNA have provided as it relates to COVID, but as you see the collaboration with CureVac is not only focused on that but potentially broader, and we think there is opportunities for mRNA to provide benefit to patients in other infectious diseases, and possibly even beyond infectious diseases. It’s also important to note that our focus on immunology really helps us understand what kinds of immune responses are needed for every different type of infection, allowing us to leverage mRNA in some instances, self-amplifying and others, the other platforms that I mentioned. I think that our focus on immunology will fit very nicely with our deep successes we’ve had in vaccines to allow us to really bring all of this to patients in a much more effective way.

Thank you. Next question, please.

Thank you, and your next question comes from Laura Sutcliffe from UBS. Please go ahead, you’re live on the call.

Hello, thank you. First question is on your existing flu sales line. I think you’ve indicated that your volumes in the U.S. will be pretty flat this year. Should we take that as a sign that you have gone as far as you can with your existing flu set-up, or is there any scope to grow again beyond this year? Then secondly on Cabenuva, are you going for a full U.S. launch immediately or are you thinking of waiting until later in the year, when the environment for launching a drug like this is maybe a bit easier? Perhaps you could give us a picture of what market access is looking like over there as well. Thanks.

Okay, well let’s come to David about Cabenuva, because this really is a very important pioneering [indiscernible] leading the way for patients living with HIV and can be a foundation in many ways for the pathway forward for, as David said, accelerating growth. We’re really looking forward to that, but as you’ve said, it is a new paradigm in behavior in a not simple environment. On flu, I think Roger alluded to this as well, which is--well, Iain covered it in terms of the forecast which you picked up - you know, it was a tremendous year in ’20. We’re expecting volumes but some pricing pressure for ’21 just due to phasing of RAR, but I think if your question underlying that is old technology versus new, I don’t think we should walk away thinking mRNA is going to be the solution to all vaccines. As Roger said, it really is--there are some disease areas it’s not relevant, there are others it’s going to be very important to bring combinations. It is probably highly relevant for flu and, indeed, potentially with combinations of respiratory infectious diseases, so this is an area where we’d be looking at new technology platforms in terms of any other future plan, but more on that later. Let’s come to David on Cabenuva plans and access question.

Okay, thanks Laura. I think the short answer is yes, we’re going for a full launch of Cabenuva, and in fact we’re shipping this week in the U.S., first the oral [indiscernible] and then the injectable will be shipped in the very near future. The reason we’re doing that is this is the first long-acting therapy for HIV, and there’s definitely pent-up demand for it. As I said in my remarks, [indiscernible] HIV patients have expressed interest in long-acting treatments. We saw from the clinical trials that recruitment went very fast and patients wanted to--adherence was very high, and patients wanted to remain on the medicine, so there’s definitely a pent-up demand and a very sort of passionate group of patients who, for all sorts of different reasons, [indiscernible] but often the stigma and the emotional burden of taking daily oral pills want to access the Cabenuva, so we are launching. As always, it will be a build. There is some set-up for physicians who have to get used to giving injections, but we’ve been working with practices across the U.S. to set that up, but there will always be early adopters. We have to go through reimbursement as always with the different formularies and so forth - that normally takes a quarter or so, but nothing particularly unusual here versus any other launch. We will be launching it, we’ll build momentum, and in the very near future or in the next few weeks, we will also file in the U.S. for the eight-week data, so every two months based on the eight-week data that we’ve already got, and that will go in. We’re really excited to get going on Cabenuva and we know patients are waiting for it.

Thanks David. Next question, please.

Thank you, and your next question comes from Geoffrey Porges from Leerink. Please go ahead, you’re live on the call.

Thank you very much, and appreciate the answers to the questions here. I’d like to ask a question about the future and COVID. It’s nice to see GSK really getting engaged with the response to COVID now. Normally I’d ask Luke to answer what the future looks like in a COVID-free world, but perhaps I’ll direct my question to Hal. Hal, I’m getting mixed signals from GSK. On the one hand, your financial commentary suggests that you expect medical activity, and particularly Shingrix to return towards normal by the end of the year and then be more or less normalized with catch-up next year. But you’re still committing to developing a COVID vaccine and more engaged with developing a COVID antibody despite that outlook, so could you help reconcile those signals? Particularly, you’ve mentioned these variants, and I think there’s near panic about them now, but do you think that the so-called South Africa variant with the triple mutation, that the receptive binding domain is a terminal adaptation of the virus, or do you think that this is going to be a whack-a-mole, every six to 12 months the virus is going to mutate to an immune escape variant that we’ll have to continue to iterate against?

We’ll come to Hal in just a second, but just to repeat, the assumptions in the outlook that we’ve given and that Iain laid out is that we would expect - and this is really in our large developing markets - that healthcare operating systems return to verging on normal in the second half of the year. This is because we are assuming successful--in this scenario, successful deployment of the vaccination of COVID. As Iain said very clearly, the variants in that will depend on the pace of that, the infection rates. At the same time - and Hal can certainly comment on this scientifically and epidemiologically, it is clear that this virus is continuing to mutate, and we do expect some kind of endemic market, although as you’ve all seen, the data is showing in different degrees under different vaccines, a degree of protection on certain mutants to date. But Hal--I just wanted to clarify what the assumptions are and what we’ve laid out, and then Hal perhaps can comment on the ongoing opportunity for COVID, not least with the hesitancy rates in some countries with vaccination anyway. Hal?

Thanks. I think it’s pretty clear despite the robust reduction in symptomatic disease with the vaccines that we’ve seen, that we’re really just beginning. There’s already evidence, as Roger mentioned, from vaccine trials that the protective immunity from some of the vaccines is lower in certain patients with the virus that has mutated, and these variants of concern that are emerging are probably not going to end. There will probably be more variants. I think that our approach is very consistent with that. From the very beginning, we were worried about mutations and hence did the deal with Vir for monoclonal, and that was binding to an epitope that we believe was very unlikely to mutate because of how it was discovered, through being both observed and effective in SARS-CoV-1 patients, but also highly neutralizing in the current COVID-19 epidemic. We were from the beginning imagining these variants coming out and developing this monoclonal, which we think will have significant benefit for those patients unfortunate enough to contract the virus. We’re also not resting on that. We do have, as I mentioned, combinations with a Lilly antibody should the mutations emerge even more robustly than we expect, and of course from a vaccine perspective, given these mutations, whether it becomes another pandemic or, more likely, an endemic state, with the multivalent mRNA vaccine potential that we have CureVac, I think our strategy from the beginning has been very consistent, that that is likely an outcome and now we’re moving forward. I should also say that in addition to being able to prevent the hospitalizations with the VIR-7831, we do have a trial with the NIH looking to see even if you can reduce the morbidity of patients being treated within the hospital, as well as our otilimab therapy as I mentioned, which I think leverages our really deep understanding of the immune system and evolving understanding of how the COVID pulmonary syndrome evolves, and we’re cautiously optimistic that that could potentially be a treatment option for those patients whose severe pulmonary COVID symptoms are GM-CSF mediated. It’s a bit of a three-pronged, maybe even four-pronged approach, and I think it’s been relatively consistent from the beginning.

Great, thank you Hal.

Thanks. Next question, please.

Thank you, and your next question comes from Graham Perry from Bank of America. Please go ahead, you’re live on the call.

Thanks for taking my questions. First one is just going back to a follow-up to James Gordon’s question at the beginning, just about the recovery rate in 2022. You’re flagging the ’21 hit from COVID as temporary and then strong recovery in 2022. If you look at the consensus EPS at the moment, it’s about 120p, so that’d be about 20% EPS growth in 2022 over what your guide is implying for 2021. Could you help us with your level of comfort with where that is, or perhaps which variables consensus should be thinking about for their 2022 forecasts? Then secondly, you talked about giving dividend policy for the biopharm business as well as an outlook over the midterm in June. Do you expect to give a range for payout ratio or cover, or even declare a very specific, what the 2022 dividend would be as a base early, to give the market some sort of certainty? When you’re saying about factors that go into--anything about having an appropriate dividend through the cycle, can you just help us understand what factors go into that? Are you benchmarking against other companies, and which ones would you consider to have an appropriate dividend policy? Thank you.

Yes, okay, two important questions. Iain, do you want to pick up both on outlook and clarity of what’s coming on the dividend or distribution policy, versus dividend value?

Absolutely. As you might imagine, Graham--thanks for the question. As you might imagine, we’re not providing 2022 guidance today, but what we are doing is [indiscernible] we expected this time last year around attractive revenue growth and adjusted EPS growth from 2022 onwards. With the exception of the in-year impact that we see for 2021 in our vaccines business, [indiscernible] fairly clearly our assumptions and some of the factors that will influence that outcome. The progress that we’re seeing in our consumer healthcare business and our pharmaceuticals business remains very much on track, and I think is probably a key signal in that within the pharma business is that the growth that we see coming through from the new and specialty medicines in 2021, which we--well, we saw in ’20 and we very much expect to see continue in ’21 and into 2022. So without confirming or denying any of the guidance, we are very confident in the progress we’re making across the businesses. We’re very confident in the prospects for the vaccine business beyond the impact of COVID-19, for all the reasons that Emma and Roger have set out, and what we will do in June, we’ll set out in considerable detail those medium term financial outlooks that inform the top line - our margins, our adjusted EPS, balance sheet structure and the like, and what we will also do in June is set out the key factors that inform the dividend policy and the dividend policy for that new GSK, the new biopharma business. You obviously already have a range, a possible payout range, probable payout range for the consumer healthcare company post separation, but what we will do is set out those factors, which clearly is--and I think you answered the question yourself, the comparison to our peer group, so what are appropriate through the investment cycle, and by that I mean we obviously have variability in earnings per share on an ongoing basis, but just looking at the appropriate payout ratios through the investment cycle and appropriate, robust coverage from a free cash flow perspective, and importantly the propensity to grow from point at which we reset it in 2022. I think what we’ve been clear today is that we would expect the aggregate distributions for the biopharma business and the consumer healthcare business standalone to be less than they presently are today, but that importantly they have the propensity to grow and to be progressive dividends from that point onwards. We will provide the information that helps everybody to model this through and think about the investment case in the round, not just in the very specific context of a dividend policy, which is principally why we’re not giving you the full detail on that policy today.

Yes, fantastic and hopefully clear for everybody. Next question, please.

Thank you, and your next question comes from Jo Walton from Credit Suisse. Please go ahead, you’re live on the call.

Thank you. I have two questions. If we look at the guidance for 2021, at the sales level at the divisions, you know, flat to growth; at the group level’s earnings, it’s mid to high single digit decline. There’s clearly an increase in cost coming through here. I think we understand that R&D is rising as one of the main elements of that, but I wonder if you could take us through some of the other aspects of the cost structure that we should be expecting for the group for 2021. My second question is just looking at the older established products. They were down 15% on a constant currency basis for the full year, 18% in the fourth quarter. Do you have any help on how we should be looking at that block going forward, because you haven’t made any disposals from it yet? Should that decay rate be easing as we begin to see the impact of Advair generics and the price erosion in the respiratory market, which is obviously a big part of that, beginning to ease, or with a new entrant coming in for generic Advair, could that whole respiratory price still reset further in that $3 billion-plus portfolio that you have? Many thanks.

Okay. Great, thanks Jo. Iain will add more color to this, and I think particularly around the established product dynamics, although I would repeat we are looking continually at the portfolio there, and that’s obviously where we do target selective divestments too. But the headline is, and again Iain alluded to it, with pre-R&D we’ve already made progress. We expect to continue to make progress there. There’s also an element of tax and revenue mix as well in the EPS outlook. The only difference on where we were previously is the vaccine contribution to total growth is just quite different than we might previously have expected, although just to keep reiterating, that is a short term [indiscernible] ever needed to believe that having the kind of strength in vaccines and infectious diseases was relevant, important, and created significant long term growth opportunities and resilience for the new GSK, now is definitely a time to have conviction [indiscernible]. But Iain, do you want to just--I don’t know if there’s anything I missed on the guidance.

Yes, revenue mix is important. I think Jo, you certainly got the dynamic on the top line right, but the mix of those revenues clearly with some COVID-19 pressure on the vaccines business has a little bit of a mix effect on margin, as you can well imagine. Then the continued [indiscernible] investment in R&D incenting the pipeline, a key focus, and an effective tax rate of around 18%, being a step up of two percentage points from this year, are the key factors that translate from the top line outlook through to the adjusted earnings per share outlook. Reflecting your question on the established pharma, and as I mentioned earlier, David and the team are focused and active on a number of transactions in the established pharma portfolio, [indiscernible] on the detail on either which parts of that portfolio, but it is an area where with Luke and David, we spend a good deal of time looking for when the right time and the right value is to exit certain medicines within that portfolio that are reaching, frankly, an NPV inflection point from a GSK valuation perspective. Particularly when we get to the point where Luke and the team are no longer investing behind a particular product in terms of promoting a product, we start to think very actively about the opportunity to exit those portfolios, but it is very disciplined in terms of how that balances out from an economic perspective and NPV. More specifically around the pricing dynamics, particularly in ICS/LABA class, we’ve seen certainly through 2019, continuing in ’20, and frankly no reason to expect that it wouldn’t further continue to some degree, although probably a little bit more muted than ’20 and ’19, pressure in that class, and very much driven in our experience by the genericization in Advair/Seretide. If anything, we saw that influence a little bit muted in 2020,where we saw those medicines being possibly prescribed either in larger prescriptions or more so in terms of response to respiratory health in a COVID-19 setting. But in terms of the trajectory for that medicine over time, our outlook on that has not changed from when we first announced generic competition in that space. I think what we have seen, and we’ve been clear about, is the pricing pressure in the ICS/LABA class, and that we would expect--you know, it has been pretty severe. The discounting in that space is very marked, and we wouldn’t necessarily expect to see that abate, but nor would we necessarily expect to see it exacerbate much further.

Thank you. Next question, please.

Thank you, and your next question comes from Louise Pearson from Redburn. Please go ahead, you’re live on the call.

Hi, thanks for taking my questions. Firstly for Luke on [indiscernible] start with data due later in the year, just give some recent developments in the space, could you remind us of how you’re thinking about that asset and the options you might on the table, should the trials read out favorably? Then one for Roger on the RSV older adult program, does the Phase 3 design assume a pre-COVID incidence of RSV [indiscernible], is there a risk to the program that social distancing affects [indiscernible] degree, meaning that there’s less RSV going round and maybe a signal might not be seen? Thanks very much.

Okay, so straight to Luke and then Roger.

Sure, thanks Louise. So increasingly positive about daprodustat for a couple of reasons, which I’ll go through now. Just as background for everyone, we’ve got five studies, about 9,000 patients, two of them are May studies and they’ve fully recruited. The patient population in the U.S. is about 2.7 million--or U.S. and EU in non-dialysis is about 2.7 million patients, so a sizeable population. I think what’s changed, if you go back, say versus 24 months ago, 12 months ago, our assumption always was that you would have seen roxadustat on the market relatively early, followed by vadadustat, both of them having non-dialysis and dialysis indications. I think the increased likelihood, we know that roxa’s PDUFA is on March 19 this year. Our assumption is that they get non-dialysis and dialysis. Vadadustat is in Q3 ’21 with PDUFA, and our assumption is that they only get dialysis, if approved. With our timeframe, toward the end of the year we expect to get non-dialysis and dialysis, so a competitive profile. I think a third thing is we’ve seen [indiscernible] Japan launch different labels that our partner has actually got 42% market share--you know, very, very--so roughly the same as the nearest competitor in a very, very heated market., so yes, I think we’re more optimistic about daprodustat than we were even a few months ago.

Thanks Luke, and then over to Roger on RSV. I know we’re [indiscernible] a readout in the second half of ’22 [indiscernible], and then we’ll come to the last question.

Yes, exactly. I think that we’re obviously watching this very carefully, and the trial design, just to reiterate, we think there’s a major opportunity in RSV in older adults, just because of our ability to be the first and best in class. One element of modeling that we’re doing obviously, and I won’t go into the detail of the trial design, is looking up the population geographies and numbers that we want to make sure that we--that we select. That’s going to be very critical in the trial piece. One important assumption is that we really see the bulk of the population, of the affected population here being vaccinated in the first six to nine months of this year, which I think is important because then you have that vaccinated population, that’s the at-risk group that we’ll be studying through the study, so we think that as we get through that mass vaccination, we’ll see less impact in terms of overall risk of the COVID circulation as well.

Thanks Roger. Last question then, please.

Thank you, and your last question comes from the line of Andrew Baum from Citi. Please go ahead, you’re live on the call.

Yes, thank you. The question might come as a surprise given our research, but you’ve outlined the separation as most likely taking place as a de-merger. Given the demand from GSK pharma to future-proof their outlook, particularly being aware of the dolutegravir, cabotegravir loss of exclusivity, why not a partial IPO in order to increase your firepower for M&A, simply because with Hatch considerations are so onerous that it makes it less attractive, so if you can, Iain, just comment on that, that would be interesting. Then second for Hal, perhaps you could update us for the durability of response you’ve seen with your ICOS agonist in INDUCE-1. I think the last update you gave was at six months, [indiscernible] patients who had a response didn’t maintain their response. Maybe you’ve updated since then, but if you could update this further, that would be helpful in just thinking about whether we’re seeing additive or synergistic efforts [indiscernible]. Thank you.

Thanks Andrew. We’ll come to Hal in a second. You set the mechanism for separation in the context of dolutegravir. I mean, we’re all more than familiar with the requirement for replacement rates in the face of patents, and I just really want to emphasize our confidence in the progress under Hal’s leadership, and ever more so in the prospect of our vaccine portfolio and developing a strong pipeline, including in long-acting in HIV, and all of that will bring more visibility over coming months and years. But it’s very important that we reiterate the confidence there, and as Iain also referred to, one of the benefits of this separation does allow for the de-leveraging of the biopharma business, which in all worlds is going to continue to prioritize from a capital allocation point of view the pipeline, including business development. We remain, we hope, strategic, selective and disciplined on the way that we pursue that, but we are thoughtful about continuing to create capacity, and that’s also why we want to give a holistic view of this new company, its capital structure, the ability to support investment in all the growth opportunities we see inside and outside the company, and competitive appropriate returns. The technical mechanism of the separation will be confirmed later this year. You will imagine that we are, with the board, in ongoing dialog with our partners and really thoughtful about what’s in the best interest of shareholders, and we’ll confirm the specifics of that later in the year. Iain, before I hand to Hal on ICOS, anything that you would add to that?

No, well said, Emma.

Okay. Hal, over to you for the last response today on ICOS, until tomorrow’s discussion.

Thanks Andrew. We have a lot of catalyst events for the ICOS program in the next six months - as I mentioned, the INDUCE-3 interim analysis, the Entrée Lung randomized Phase 2 data, and also some updates from INDUCE-1. I’m hoping that we’ll have more updated data on duration of response from the INDUCE-1 studies when we provide that, which we hope will be somewhere around midyear. I don’t want to comment on any numbers yet, but as I mentioned, we’re excited about the data readouts that we’ll have for those three programs, and we’ll share more of that data with you soon.

Thanks Hal, and a big thank you to everybody for this slightly extended discussion today. We look forward to further conversations, actually some today and tomorrow, and in the weeks and months ahead, and for a very exciting next 18 months for GSK and future junior company. Thank you, have a good day.

Thank you Emma. Everyone, that does conclude your conference call for today. You may now disconnect. Thank you for joining, and enjoy the rest of your day.