Earnings Call
GSK plc (GSK)
Earnings Call Transcript - GSK Q1 2021
Operator, Operator
Good afternoon, ladies and gentlemen, and welcome to the Analyst Call on the GSK First Quarter 2021 Results. I will now hand you over to Iain Mackay, our CFO, who will introduce today's session.
Iain Mackay, CFO
Thank you. Good morning, good afternoon. Thank you for joining us for our first quarter 2021 results, which were issued earlier today. You should have received our press release and can view the presentation on GSK's website. For those 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. Speakers today are Emma Walmsley, Luke Miels, David Redfern, Brian McNamara, and myself, Iain Mackay. Joining us for the Q&A portion of the call will be Dr. Hal Barron and Roger Connor. We request that you ask 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.
Emma Walmsley, CEO
Thanks, Iain, and a very warm welcome to you all. We continue to deliver on our strategic priorities and remain very focused on creating significant value for shareholders with the launch of two new global companies next year. Both companies have the opportunity to improve the health of billions of people, and we're confident that both will offer strong performance in 2022 and beyond. For 2021, our focus is on execution and delivering this very significant change for GSK. I'm pleased to report that we're on track, both on plans to separate and to deliver financial guidance for the year. So, turning to the quarter, our financial results were impacted by comparisons related to stocking in Q1 2020 and disruption from the pandemic. First quarter sales and adjusted EPS were down 15% and 33%, respectively, at constant exchange rates. We expected a challenging start for the year, but with these pandemic impacts starting to reverse in the current quarter, we are confident will deliver a very different performance in the second half of the year, and Iain is going to go through this shortly. Turning to our strategic priorities, we continue to see progress on each of innovation, performance, and trust. In innovation, we strengthened our growth outlook on several fronts. Firstly, we are reshaping the landscape of HIV treatment with the launch of Cabenuva, the world's first and only long-acting injectable. We achieved important regulatory milestones with the approvals of Rukobia and Dostarlimab and Jemperli, and a positive CHMP opinion on Benlysta. And we started Phase III programs for two major pipeline assets, our RSV vaccine for older adults and 294, our long-acting IL-5 antibody, which builds on our Nucala success. We also made progress in our COVID contributions, including reporting strong data for antibody VIR-7831. Of course, it's never all progress in drug development, and the news received this quarter regarding the ICOS agonist was disappointing. But it should be seen in the context of GSK developing more than 10 novel oncology pipeline assets as well as the broader pipeline progression—a significant shift from where we were just a few years ago. In performance, the underlying momentum of our growth drivers is strong, albeit overshadowed short-term by the COVID-driven impact on the wider portfolio. This reflects transformed commercial capabilities, as you're going to hear shortly from Luke, David, and Brian. Shingrix is an outstanding product and continues to have a very large opportunity ahead of it. This quarter, prescription trends were heavily impacted by the rollout of government COVID vaccination programs. Looking ahead, we continue to expect, and we'll be driving a recovery for Shingrix and a wider vaccines business in the second half of the year, given the encouraging pace of deployment of COVID vaccines in the U.S. Alongside commercial delivery, we've made excellent progress on our Future Ready program. The commercial integration of consumer health is now broadly complete. We've generated more than $1 billion in net proceeds through tail brand divestments, and separation activities are advancing well. We also continue to streamline our pharma portfolio, and this quarter we announced an agreement to divest our cephalosporin business. And lastly on trust, our focus remains on maintaining leadership across all areas of ESG, and this is evident again this quarter with actions taken on environment, global health, and diversity representation. We look forward to driving momentum in all three core priorities and delivering a significant improvement in financial performance as the year progresses. Before I hand over to Luke, I want to highlight what we will share with you at our Investor Update on June 23. We will provide you with a clear view of the strategy for new GSK, its outlook for growth, and the opportunities we see for shareholder value creation. As part of our strategy, we will provide clarity on our target therapeutic areas for investment, revenue outlooks for the next 10 years, with greater detail for the first five years. We will set out how we expect to deliver competitive performance. This will include deep dives into new growth drivers, including key R&D pipeline assets, as well as deeper visibility of new GSK's key capabilities and technology platforms. We will also outline our capital allocation priorities and provide you with details on our expected dividend policy. And lastly, we will set out in more detail the timing and approach of separation. We are very aware that GSK shares have underperformed and will demonstrate how we are building shareholder value in new GSK. With the foundation of deep change in progress made over the last few years, we believe we've developed a compelling vision and outlook to share with you, and we hope as many of you as possible will join us on the day. With that, I'll hand on to Luke.
Luke Miels, CFO
Thanks, Emma. We continue to make great progress on commercial execution and competitiveness in the quarter, with strong share performance across our key and new specialty growth drivers. As expected, the performance across our vaccines business was disrupted heavily by the pandemic, so let me start first with an update on Shingrix for which we remain confident for a recovery in the second half. Shingrix sales declined by close to 50% in the quarter, reflecting the expected headwinds we highlighted in our last quarterly earnings call. The prioritization of the public health systems to focus on pandemic vaccination deployment has led to significant disruption in Shingrix prescriptions. This has been most evident in the U.S., where the CDC has recommended a 14-day window either side of receiving COVID vaccines, effectively creating a two-month no-go period for the administration of other vaccines. We are seeing similar disruptions in other key markets, including Germany and China. The encouraging news is that the pace of administration of pandemic vaccines among U.S. adults has been rapid, especially those in the target age group for Shingrix. By the end of the second quarter, we expect the majority of adults aged 50 and over to be fully vaccinated. Furthermore, with two-thirds of those aged 65 and older in the U.S. fully vaccinated for COVID, we are seeing a weekly rolling four-week NBRx increase of 27% in this population compared to the prior period, attributed to an increasing proportion of Shingrix-eligible consumers progressing beyond the COVID vaccine period. This backdrop supports our confidence in the second half recovery in Shingrix, and we've been enacting strategies to drive this recovery. For example, we've been partnering with U.S. retailers to rollout minor programs to encourage eligible adults to come into pharmacies two weeks following their final COVID vaccine. We've also seen encouraging market research data suggesting that eligible adults intend to return for the Shingrix vaccine within one to three months. On a global basis, we've been working hard to ensure that we have a strong supply position to leverage the expected upswing in demand, as we are in the process of doubling the number of launch markets in 2021. To summarize, we continue to believe the disruption to Shingrix is a timing issue. With strong underlying demand, we expect Shingrix growth to be weighted to the second half, assuming we progress towards more normal operating conditions in our key markets. Moving onto the medicines portfolio, our recent product launches and lifecycle innovations again delivered key drivers of growth in the quarter. Starting with oncology, we continue to make inroads with Blenrep in its second full quarter on the market. Blenrep is the only anti-BCMA therapy administered through an off-the-shelf infusion, and we've had positive feedback from ADCC as they gain increasing familiarity and confidence in the management of corneal events. We've now more than 1,200 healthcare sites set up with more than 1,000 patients enrolled in the REMS program in the U.S. and more than 1,200 patients treated globally. Early uptake has been driven by myeloma experts and academic medical centers, and we're now expanding our reach into the community setting. We also continue to expand Blenrep globally with launches gathering pace in Europe. On Zejula, significant market share gains were offset in revenue terms by the suppressed ovarian cancer market, one of the many tragic consequences reported as patients remain undiagnosed. Since Q3, debulking surgeries are down 20%, which has impacted the number of patients initiating chemotherapy. In terms of new patient share, we're up to 51%, and our share of voice among HCPs is the highest in the class, now 52%. We've worked hard to drive awareness, and we are pleased to see that watch and wait in the U.S. has decreased to 16%, while patient awareness of maintenance therapy has increased from 29% this time last year to 45% in early 2021; these are indications of positive progress. Outside of the U.S., we’ve seen growth launches in Germany and the U.K. Looking ahead, the impact of reduced surgeries will likely continue in the short term, but as demand stabilizes, we expect to see a return of diagnosis, debulking surgeries, and chemo initiation, leading to a consequent return of sequential Zejula growth. Moving to respiratory, Trelegy performed very strongly with sales up 35% in the U.S., led by the U.S. Sales are now annualizing at about GBP1 billion, just less than four years from launch. We continue to lead the total triple market, with share three times higher than the number two product’s, and that indication in the U.S. is proving to be a key differentiator. Since the launch of the asthma indication, we've seen a 65% increase in asthma patient share, while new-to-brand prescriptions from allergists quadrupled in Q1. Outside the U.S., the NRDL listing in China started to take effect in March, and in Japan, our second-largest market, we are now the leader with 76% market share. We're also excited about the continued growth opportunities with Nucala; we are now the leading IL-5 across the broadest range of eosinophil-driven diseases in all major markets. First-quarter sales grew 26% and, like Trelegy, are now annualizing at about GBP1 billion. A lifecycle innovation to Nucala with indications HSE, GPI, and FCA, and expected approval in nasal polyps later this year, has been a key success driver in helping more patients receive therapy. In addition, we believe the categories in which we compete are still very under-penetrated, with only 28% of eligible SCI patients in the U.S. currently receiving a biologic and even less in other major markets. While on the slide, I also wanted to highlight the fantastic performance we've seen from Benlysta, where we again drove double-digit growth after 10 years on the market. Let me now hand over to David to talk about the great performance of Dovato and the major potential of cabotegravir.
David Redfern, Chief Strategy Officer
Thank you, Luke, and hello everyone. First quarter HIV sales declined 11% reflecting a strong Q1 2020 comparator, which benefited from around GBP100 million in stock build and the timing of an international tender. Adjusting for these factors, Q1 sales would have been broadly flat versus the prior year. Looking ahead, we expect these phasing impacts to reverse in Q2 and we remain confident of delivering our full year growth objectives. On a strategic level, our HIV business has been a first mover in the development of two drug regimens and long-acting regimens. In recent months, we've seen validation of this strategy by competitors who are now shifting their focus in both of these directions. Importantly, our new products Dovato, Juluca, Cabenuva, and Rukobia now make up 25% of our HIV portfolio. Turning to Dovato, sales more than doubled in the quarter, and it has become a key driver on track towards the $1 billion in sales. Our leading share of voice in the U.S. and Europe, along with the U.S. label inclusion of the TANGO switch data, has helped to drive Dovato's share of the switch market to approaching 20%. The growing momentum behind Dovato in Europe has also been reflected in strong and increasing market shares across the EU5. Moving to our injectable portfolio, we have a rich stable of long-acting assets centered around cabotegravir. This foundational medicine has incredible potential, with patent protection beyond 2030. In February, we launched Cabenuva in the U.S. as the first and only every four-week treatment for patients living with HIV and we have submitted a supplemental NDA for every eight-week dosing. Early indications from HCPs and KOLs are positive; it meets a real unmet patient need, replicating the market research and clinical trial findings. We were particularly pleased with the very high level of prescriber attendance at the recent national Cabenuva launch broadcast, demonstrating strong levels of engagement and positive sentiment. The European launch, with every eight-week dosing, will be underway in the coming weeks under the brand names Vocabria and Rekambys. Turning to prevention, the 083 and 084 studies strikingly demonstrated that cabotegravir, every eight weeks, was superior to Dovato in preventing HIV acquisition in men and women, and we are on track to submit the file to the FDA in the first half of 2021. In summary, we remain confident in the outlook for progressive acceleration in growth in HIV, underpinned by the momentum of Dovato, the launch of Cabenuva, and the expected launch of cabotegravir in the prevention setting. With that, let me hand over to Brian to talk about consumer.
Brian McNamara, CEO, Consumer Health
Thanks, David. We remain on track to create the world's leading consumer healthcare company; updating you on progress to date, our divestment program generating GBP1.1 billion in net proceeds is complete, resulting in a strong focused portfolio well placed for sustainable growth. On integration, the commercial integration is largely complete and manufacturing work is underway. Separation activities are progressing well. Importantly, all of our guidance for fiscal year '22, including margin synergies, remains unchanged. Turning to Q1, the quarter was impacted by tough comparators given pantry loading across all categories last year and a record cold and flu season, resulting in Q1 continuing sales, excluding brands divested and under review, down 9% at constant exchange rates. Recognizing the unusual year-over-year comparators, two-year compound annual growth rates (CAGRs) are more indicative of the underlying category trends. On this basis, all categories are up apart from respiratory. Overall health sales declined slightly in the quarter, with a two-year CAGR of mid-single digits. Q1 saw continued outperformance of gum health and Sensodyne, while pain relief saw Q1 sales down high single digits, with a two-year CAGR of mid-single digits. The continued success of the Voltaren Rx OTC switch in the U.S. last year was offset by Advil and Panadol weakness due to pantry load comparators. In vitamins, minerals, and supplements, sales declined slightly in the quarter, with a two-year CAGR up high-single digits. Digestive health and overall sales were flat in the quarter, with a two-year CAGR up slightly. Respiratory sales declined 42% in the quarter, with the two-year CAGR down in the teens. Cold and flu remains under pressure due to continued social distancing. For example, in the U.S., IRI data showed a category decline of over 60% in the 12 weeks ending March 27. However, we expect more normal consumer trends in the second half of the year. E-commerce grew over 30% and is now around 7% of sales, up 2% from last year. Our continued investment in digital capabilities positions us well for growth in this channel. Innovation remains a key focus and an important growth driver. The success of the Voltaren Rx OTC switch was coupled with other successful innovations, such as Sensodyne sensitivity and gum and new launches including Pronamel enamel repair. Turning to our power brands, seven of the nine brands gained or held share. In addition, we saw double-digit growth in the quarter from our continuing business in emerging markets. Our fiscal year sales outlook remains unchanged. With temporary integration activities well underway, we are well placed. I remain excited and optimistic about our journey to create the world's leading consumer healthcare company. With that, I'll hand it over to Iain.
Iain Mackay, CFO
Thanks, Brian. All the comments I make today will be on a constant currency basis, except for where specified otherwise, and I'll cover both total and adjusted results. On Slide 14 is a summary of the Group's results for Q1 2021. We stated in our full-year 2020 results that we expected Q1 performance to be challenging given the strong comparator from 2020, and that's been the case, as you've already heard from the team. As such, I'll focus on key numbers performed in Q1 and provide important considerations for Q2, as well as the shape of 2021 overall. Reported turnover was down 15% at constant exchange rates, total leveraging profit was down 8%, with total EPS down 25%. On an adjusted basis, operating profit was down 23%, while adjusted earnings per share was down 33%. In terms of free cash flow, in line with our expectations, we had an outflow of 3 million pounds in the first quarter. As noted in our full-year 2020 results, we expect free cash flow to be lower in 2021 compared to 2020. On currency, the strengthening of sterling against the US dollar and weakness in emerging market currencies relative to Q1 2020 results in a headwind of 3% in sales and 6% in adjusted EPS. Slide 15 summarizes the reconciliation of our total to adjusted results; adjusted items of note for the quarter were in disposals, largely reflecting the profit on disposal of rights to the cabozantinib royalty stream, and major restructuring reflected continued progress on the separation preparation programs and consumer healthcare integration. Please also note that, as referenced in our Annual Report, the 2021 UK finance bill is passed, resulting in an increase in the UK Corporation tax rate from 19% to 25%, which will be a significant positive revaluation of deferred tax assets in the UK later in the year, treated as an adjusting item. My comments from here onwards are on adjusted results unless stated otherwise. On this slide, let me cover the key drivers of revenues and profits for the Group in Q1 compared to the prior year. The sales decline was informed by unfavorable year-on-year comparisons due to stocking and pantry loading, the ongoing pandemic impact on vaccines, and the very weak cold and flu season impacting consumer. We will comment shortly on the drivers by business for the second quarter and for full-year projection. The negative impacts on sales, operating profit, and margin were mitigated by tight cost control across the business, with increased investment in R&D contributing to 215 of the total 290 basis points margin reduction, resulting in an operating margin of 25.4%. R&D growth of 3% reflected continued investment in progressing our pipeline and was driven by a significant increase in investment in specialty medicines related to our key COVID-19 treatment programs, VIR-7831 and otilimab. There was further incremental investment in the progression of several key programs, including Zejula, Jemperli, and 294 anti-IL-5 in pharma, as well as RSV and meningitis ABCWY in vaccines, partly offset by phasing and spending on Blenrep. Efficiency savings from the implementation of our one development program and reduced variable spending as a result of COVID-19 lockdowns remain strong. We continue to expect R&D growth for the group to be low double digits for the full year. Lower SG&A, down 15%, in line with sales, reflected ongoing tight control costs across the group, continued benefits of restructuring, and reduction in variable spending as well as year-on-year favorability concerning legal costs, which contributed around a third of this decline. With a strong focus on cost management and as I mentioned, we are making excellent progress with our future-ready program. I can confirm we are on track to deliver GBP800 million savings. Following the disposal of the cabozantinib royalty stream, we now expect royalties to be between GBP300 million and GBP350 million in 2021. Moving to the bottom half of the P&L, I highlight that interest expense was GBP190 million, similar to last year, and no change to our full-year expectations of between GBP815 million and GBP900 million. The effective tax rate of 18.6% was in line with expectations, reflecting the timing of settlements with various tax authorities. We still expect a full-year rate of around 18%, excluding the impact from any possible U.S. or UK corporation tax changes. Finally, lower non-controlling interest reflected Pfizer's share of profits from the Consumer Healthcare joint venture. Next, I will cover what we expect from free cash flow for the quarter before going into more detail on how each of the overarching revenue and profit drivers in each business. The Q1 free cash flow stepped down compared to the same period last year as expected, with a small cash outflow of GBP3 million for the quarter. This was informed by reduced operating profit, including adverse exchange impacts, poor timing with returns and rebates, and increased dividends to non-controlling interests. These factors were partly offset by a reduction in trade receivables from lower sales compared to an increase in Q1 2020, along with increased proceeds from disposal of intangible assets and lower tax payments. Improving cash flow continues to be a constant focus for the team. It is worth noting that Q2 will be much lower compared to last year, which saw a step-up due to higher Q1 2021 sales collected in Q2, along with lower tax payments. Moving on to performance in the pharma business. Slide 19 summarizes the Pharmaceuticals business; overall revenues declined 8%. This was broadly as expected, with approximately half of the decline due to prior period stocking and another half due to pandemic pressures and antibiotics and generics in Japan. The UN specialty pharmaceuticals revenue grew 3% for the quarter, reflecting continued strong commercial delivery across our portfolio, partially offset by phasing in HIV as David described. The Established Pharma portfolio declined 17%, with established respiratory down 11%, reflecting ongoing generic competition for Advair, Seretide, and Ventolin, as well as Xyzal in Japan. The rest of the Established Pharma portfolio was down 24%, with COVID-19 continuing to affect demand, particularly in antibiotics. Pharma operating margin was 28.8%, reflecting a 280 basis point increase at constant exchange rates despite the revenue decline, mainly due to the dynamic benefits mentioned earlier. Tight control of ongoing costs reduced variable spending compared to Q1 2020 as well as favorable legal settlements in the current quarter compared to increased legal costs in Q1 2020. We continue to expect overall flat to low single-digit percentage growth in pharma revenues excluding divestments, including a high single-digit decline in established pharma. In Q1, we announced the sale of the cephalosporin business, and we continue to review our portfolio for further opportunities to sharpen focus on our operations. This leads to an overview of vaccine performance with sales down 30%. The Q1 performance was largely informed by the rapid pace of COVID-19 immunization deployments in the U.S. As a result, Shingrix sales declined 47%. The operating margin was 25%, primarily reflecting the negative operating leverage from the COVID-19-related sales decline, as well as higher supply chain costs resulting from lower demand and adverse mixes due to lower Shingrix sales. There was also increased R&D investment behind our RSV and meningitis development programs. The advances to date this year are encouraging, particularly in markets such as the U.S. and U.K., and we expect to see further recovery in vaccine revenues for the remainder of the year, particularly in the second half. Regarding the full year for vaccines, we continue to expect flat to low single-digit percentage revenue growth. Turning to Slide 21, Q1 revenues in Consumer Healthcare decreased 9%, excluding brands either divested or under review. Including those brands, turnover declined 16%. As Brian mentioned, we've completed the tail brands divestment program in consumer. Consumer health performance was largely as expected, given pantry load experienced in Q1 2020 when continuing sales were affected due to extremely low and cold flu seasons. The operating margin for Q1 was 23.1%, down 290 basis points at constant exchange rates versus last year. Importantly, integration synergies continue being delivered by this business. Up next, we expect revenue growth across business segments to return in the second half of the year. As with our other businesses, for the consumer, we see no change in expectations for the full year; we expect low to mid-single-digit percentage revenue growth, outperforming the market. Finally, on our group 2021 outlook, we are reconfirming our EPS guidance range, assuming as outlined in full-year 2020 results. By our assessment, we expect healthcare systems and consumer trends to approach their normal trajectories in the second half of the year in our key markets. Our full-year revenue expectations for each business also remains unchanged, but other important considerations will influence Q2 performance. As I've already mentioned, results throughout the remainder of 2021 will reflect the phasing and the comparator periods, as well as the progress of immunization programs and the extent to which pandemic conditions ease. Taking account of mentioned factors for Q2, we expect sales to grow mid- to high-single digits for the group. In terms of P&L considerations for Q2, we anticipate that SG&A will increase broadly in line with sales, while investment in R&D will increase mid-single digits. Overall, the pandemic disruption to our portfolio during H1 this year will result in H121 performance being below that of H120. Despite the short-term impact, we remain confident in demand for products and expect a strong recovery, particularly from Shingrix in the second half of the year. As mentioned earlier, our new GSK Investor Update on June 23 will provide more details on our mid- to long-term financial outlook, capital allocation priorities, and dividends. With that, operator, we're ready for Q&A.
Operator, Operator
Your first question comes from Mark Purcell; you are live on the call. Please go ahead.
Mark Purcell, Analyst
Yes, thank you, and thank you for taking my question. Two questions; the first one on the long-acting strategy, so David, probably one for you. Please could you help us understand the path to market for CAB 400 and how we should think about the timing and dose frequency of that subcutaneous backbone—assess every month versus every three months? Can you discuss the importance of this, given that I believe your competitors Merck and Gilead do not have anything like CAB 400 in their pipelines in terms of how important is an integrase inhibitor when it comes to long-acting combination treatment approaches? And then the second question is on mRNA vaccines more broadly? Please, could you help us understand which parts of your vaccine franchise you believe might be vulnerable to mRNA disruption? Is it just the flu business, for you guys? When you're thinking about prioritizing your own mRNA vaccine efforts, what are the key targets, and will you be running parallel programs with non-mRNA vaccine technology? Thank you very much.
Emma Walmsley, CEO
Thanks. Well, we’ll come to Roger, and perhaps Hal might want to add something as well overall on our mRNA platform approach, which we've mobilized aggressively, both with our in-house platform and with our deal with CureVac last year. But David, over to you first.
David Redfern, Chief Strategy Officer
Yes, okay, thanks Mark. Well, firstly, we are very pleased to bring the world's first long-acting injectable to the market with Cabenuva in the U.S. in February, and as I said in my remarks, we've seen a lot of interest in that from physicians and patients; obviously that will build over time. We do think the long-acting market has the potential to be significant over time, and we're investing significantly into it and R&D in the next generation. CAB 400 will really be at the heart of that, and we are looking at it subcutaneously as you say with other formulations too. Early to say exactly what the dosing frequency will be; we're looking at different intervals—one month, two months, three months, and so forth. We will have clinical trials in that and still have some data this year due in the second half. Of course, we have lots of things that we are potentially going to combine that with—whether it's more maturation inhibitor programs, bNAb, RTI, capsid, and so forth. So, a lot going on. In terms of the competition, we have to see; I mean, they've got a lot of scientific hurdles to get over. They're not integrated inhibitors, so resistance will be very important that they demonstrate that. And we'll see where they go with formulation and so forth, but I'm very excited by the program we've got and we will certainly outline more of that in June.
Emma Walmsley, CEO
Thank you, Roger?
Roger Connor, President, Global Vaccines
Yes, thanks, Mark. I'd say I think mRNA is going to form a critical part and dose form a critical part of our GSK vaccine pipeline. The benefits of the technology have been accelerated and shown recently in terms of speed to clinic and the efficacy in the manufacturer, and the efficiency in the manufacturing process. We've been investing for some time, and we've got two real plays going on here, which we’ll bring to life more in June when we share more of the pipeline. But just to give you a feeling for it: in terms of our CureVac partnership, this infectious disease partnerships we've got five potentially mRNA pathogens to develop under COVID next-generation play with CureVac as well. And also Emma mentioned our in-host self-amplifying technology in mRNA as well, which will be going into the clinic. So we see a number of assets moving forward in the next 18 months, which we'll share in June. We are investing and allocating our capital to it. So we're already looking at how we create world-class GMP manufacturing capability as well. Just to answer your question directly on where we think mRNA will play: there are certain challenges, certain areas in vaccines where it may struggle in terms of technically being applied, meningitis, bacterial infections, and complex antigens. But I don't think you can be complacent. We do believe that this is going to be a very important platform for the future. It's going to be an addition to some platforms that we already have, which we believe are world-class, like adjuvant bio conjugation, viral vectors—this will be a very important portfolio of technologies that we're going to apply to the future in the pipeline. And Hal, anything you would add?
Hal Barron, Chief Scientific Officer
No, very comprehensive; I agree.
Mark Purcell, Analyst
Could I just ask you from the perspective of Shingrix, Roger, just to the points you made? Is shingles an area where we feel mRNA could be disruptive, or do you feel that the benchmark you share with Shingrix is just too high?
Roger Connor, President, Global Vaccines
We think the benchmark on the efficacy is really very, very high and going to be difficult to match, to be honest, given the impact of the adjuvant. So again, we can't be complacent; I think lifecycle management of Shingrix, making sure we continue to expand geographically, we've got all our indications that we're working on is going to be important. But I think that's a very high bar for mRNA to come after.
Emma Walmsley, CEO
High bar and efficacy in a decade of safety. Next question, please.
Operator, Operator
Thank you very much. Your next question on the line comes from Tim Anderson. You are live in the call. Please go ahead.
Tim Anderson, Analyst
Thank you. I wanted to go back to HIV, if I can, and just the future competition from Merck and Gilead. So Merck in our TTI looks very good by itself; Gilead's capsid inhibitor looks very good. Combining the drugs, you might very well have a very strong drug that offers a once-weekly oral dosing, and they're capitalizing on these two-drug regimens. I know that you've been a big proponent of two-drug regimens? What does Glaxo have in the pipeline that makes you comfortable that you've got a competitive offering in the future, where you might have something like a once-weekly oral regimen as well? Because it seems like your franchise longer-term could be at risk by these two products that are now being combined? And then, second question, just on Shingrix manufacturing capacity: where you are in terms of having that expanded, and what percent of capacity is currently being used? Thank you.
Emma Walmsley, CEO
Thank you. Well, Roger may perhaps you can pick up on the Shingrix manufacturing. I know there has been a lot of work going on in terms of progress there, and then we'll come to David.
Roger Connor, President, Global Vaccines
Yes, listen, thanks very much for the question. We're making great progress on the manufacturing expansion, and although we've seen some demand disruption, as we've mentioned on Shingrix, we kept up production to put inventory into the system. So I think the long and short of it is, we're going to have the capacity in place to meet the demand that we foresee for the next several years. We have the new facility coming on in 2024, but we are—as I mentioned earlier—expanding geographically; we will have 16 countries by the end of 2021 and manufacturing over the next several years is not going to be a problem for us.
David Redfern, Chief Strategy Officer
Thanks for the question, Tim. So in terms of weekly oral, my understanding from Gilead and Merck is they expect to produce that combination, I think, in the mid-2020s. What I would say on that is, I think it will predominantly compete against daily oral regimens like our Dovato. The bar there being set incredibly high with all the data we now have based on efficacy and safety, and of course, most importantly, resistance. Integrators have really become the standard of care, and I certainly had enough questions around resistance as we went through clinical studies. I think we'll see when the data comes out in the next few years, but there is a high hurdle to beat and resistance will be critical. A lot of market research we've done suggests it's not clear that patients or physicians really prefer weekly oral as opposed to daily oral; and you will start to run into more adherence issues and so forth. So I think there is quite a lot to be played through there. In terms of the injectable, the long-acting injectable, I think they've said it could be a longer timeframe, probably 2027. Again, resistance will be important and remember this program is at a very, very early stage; dolutegravir in injectable form is only in Phase I. So there's a lot to go and a lot to prove, and as I said in the answer to Mark, meanwhile, we're investing a lot in second-generation with CAB 400 and so forth.
Emma Walmsley, CEO
Next question, please.
Operator, Operator
Thank you very much. Your next question comes from Simon Mathew. You are live on the call. Please go ahead.
Unidentified Analyst, Analyst
Actually, good afternoon, everybody. Thank you for taking my questions. I've got two; one on Shingrix and then one more of a strategic question. So just on Shingrix, I think if you listen to Moderna, they talk about—and I think it's widespread—not concerns, but views that potentially we're going to need to boost the vaccine for COVID-19 as we go towards the end of the year. I'm just thinking how that might play into your views on the recovery of Shingrix? Do you think there'll be potential space to vaccinate people with the Shingrix vaccine? I'm just generally interested in your thoughts on if we do have a requirement for a booster vaccine, how that could potentially impact the recovery of Shingrix in the second half. That's the first question. The second one is a more significant strategic thing; obviously, capitalized maybe last week by the news of the revelations that Elliott will building a stake. I think the question is, I mean, obviously when you announced the deal with Pfizer, initially you had views hopefully spinning off splitting this company into three years post-close—obviously, you've got a bit of space into five years post to close. You have the choice what to do and not dependent on the current positioning in the standalone strength of biopharma as it stands now; obviously, we've got a few disappointments in the pipeline, we've had COVID—there's been a lot of headwinds that we could never foresee. I mean, is there a rationale for delaying the spin of consumer? And maybe if you could comment on the enrollment of Elliott, and if you have any views on that, that would be great. Thank you.
Emma Walmsley, CEO
Well, it will come to Luke in a moment to give more content on our confidence in the reaffirmation of the outlook of Shingrix related to your booster question. I'm sure you won't be surprised that I'm not going to make any comment on specifics regarding individual shareholder engagement. But just to reiterate that we remain very committed to the pathway that we laid out at the time of the announcement of the Pfizer deal. As I said today, we are intending to give more specifics around the specific mechanism of separation when we come with the new GSK update in June. We are absolutely on track in terms of the timetable and delighted with the progress both on the scale of the consumer's successful integration and the separation plans, which are complex but absolutely well underway. All of that has continued undeterred by COVID, with a tremendous amount of work and focus from the organization. The key underneath all that is for us to bring transparency and commitment around the growth prospects. And again, that's something that we intend to do in June with a lot of confidence underneath a good improvement in performance from '22 and beyond. So, all very much on track. Luke, do you want to comment on the question around businesses and Shingrix, please?
Luke Miels, CFO
Thanks, Simon. Look, short term, there is no impact, medium-term opportunity. So, what I mean by that is: the current assumption is that countries, including the U.S., will concentrate on mass vaccinating younger people and those who are hesitant, rather than vaccinating large cohorts of variants, knowing that based on what we know now there is no waning immunity for viral escape in 2021. Plus, if you look at the timelines of companies working on the new COVID-19 vaccines, including us, we will have readouts towards the end of 2021. In terms of opportunity, if there is a role for boosters in 2022, we are very busy working on co-administration studies with the aim of having this data available in 2021. If we have this data along with some other experiments and studies, we're looking at data collecting from claims databases in respect to relationships and correlations between COVID-19 and shingles, as well as COVID-19 vaccine with shingles. This could actually create an opportunity in terms of co-administration, as we see with flu. There is a clear relationship between flu vaccines and people receiving Shingrix. So, short-term, not much of a challenge; mid-term, opportunity.
Emma Walmsley, CEO
Thanks, Luke. Next question, please.
Operator, Operator
Thank you very much. Your next question is from the line of Matthew Weston. You are live in the call. Please go ahead.
Matthew Weston, Analyst
That will be the same questions, I'm sure. So, first on RSV, clearly an increasingly competitive area and one that GSK is flagging is strategically important in the mid-term. I'm not going to ask you for comments on the competitive drug that's recently come out. But for me, it's a question around RSV rates being at such a low over the course of the last 12 to 18 months and whether or not that has any impact on the timing of your expected readouts in RSV. And then secondly, regarding pediatric vaccines. There seems to be a very big disconnect in the trends between Sanofi's pediatric vaccine revenue in 1Q and GSK pediatric vaccine revenue. Sanofi talking aggressively about the benefits they will have with hexavalent in the U.S. Can you give us an outlook as to where you see your pediatric vaccine trends going over the course of the next 12 to 24 months?
Emma Walmsley, CEO
Sure. So first, I'll come to Luke perhaps in a moment on the pediatric vaccine specifics first of all. Hal, do you want to comment on the development programs around RSV more broadly?
Hal Barron, Chief Scientific Officer
Yes, thanks. Well, your question is quite broad, but as it relates to RSV in the older adults program, we're very excited about the ample unmet medical needs. Our Phase III programs for both maternal and adult are currently progressing pretty much as planned. We indicated that when we first outlined the ARC programs at ID week last year, we expect pivotal data in the second half of 2022. Although there is a risk that the timing could be affected by the RSV disease circulation given the pandemic, we've been monitoring this. Our clinical trials groups are looking for areas in the world with re-opened economies, where there is more individual contact person risks, allowing RSV to be more common. So, we're no changes to our current timelines, and as I've mentioned, we continue to monitor this. I think as it relates to the maternal vaccine, our aim is to protect infants from birth up to six months of life through transfer of the maternal antibodies. I won't comment on the competitor information, of course, but the news is encouraging. If a monoclonal can be protective when given to an infant, then we're very excited that a pre-fusion antigen given to the mother as a vaccine with a polyclonal response would be effective. We've shown that when using that antigen that you can boost neutralizing antibodies up to 15-fold to deliver high levels of protective polyclonal responses, which is critical.
Emma Walmsley, CEO
Thanks, Hal. Luke?
Luke Miels, CFO
Sure. Matthew, I think there's two parts to this, I mean, firstly we had hepatitis; we saw CDC stocking; there has just been new stockpile interest. We've also seen the re-entry of Recombivax into the pediatric market, which put a bit of pressure on hepatitis with DPTI – similar trends in terms of CDC purchasing in the U.S. and signaling to us that they were going to reverse that in Q2; we've already seen that now. They're putting in orders already in April, and we expect that to even out over the two quarters. I think if you look at market share versus Sanofi, there are actually no material movements in market share in the DPTI market, but we do know they're out there pre-booking with Vaxelis. We do expect the competitive intensity in the U.S. and pressure on the pediatric DPTI business to increase in the timeframe you described.
Emma Walmsley, CEO
Thank you. Next question, please.
Operator, Operator
Thank you very much. Your next question on the line comes from Keyur Parekh. You're live in the call. Please go ahead.
Keyur Parekh, Analyst
Good afternoon, and thank you for taking my questions. Two, please, if I may; one for Hal and one for you, Emma. Hal, you've kind of seen two of your riskier oncology compounds have disappointing Phase II readouts recently, without disclosing the data and thinking, can you just tell us what that means from your perspective as it relates to your broader oncology R&D plans? What do you think, if anything, needs to change on that end? Where might it be different as we look toward June? And then separately, Emma, I think you alluded to Glaxo's underperformance from a stock price perspective. When you became CEO, you laid down a very clear path for Glaxo, a combined company as you saw it. Despite that, the stock's underperformed. So my question is, as we look toward June, what are you hoping to tell us that can excite investors and the market about the opportunities that you see moving forward and that drives your excitement today? Thank you.
Emma Walmsley, CEO
Thanks, Keyur. So let's come to Hal first.
Hal Barron, Chief Scientific Officer
Okay, well, thanks, Keyur, for the thoughtful question. Let me first remind everybody of the R&D focus as we outlined in 2018, which is really to focus on specialty medicines and vaccines, particularly focusing on immunology and human genetics to drive new medicines and vaccines. Within immunology, we said one of the most exciting areas involves marginally the immune system to help patients with cancer, based on the profound benefits that PD-1 blockade has had; we believed strongly that checkpoint blockade in immunology and cell therapy would be right for leveraging our deep expertise in immunology and potentially becoming leaders in the IO space—if you will, the IO version 2.0 after the PD-1 blockade. You're right; we've had two disappointing Phase II studies and I certainly was disappointed by them, but one has to remember that they were both Phase II, where industry success rates are typically around 25%. We're very excited about the potential of immunology and oncology and continue to believe that's going to be a promising area; one pathway that we think is particularly exciting is the whole poliovirus receptor and the CD226 pathway, where we have the first-in-class anti-CD96, and we struck a deal to have an anti-PVRIG. The approval of Vibostolimab allows us to have some interesting combinations, and given the CD state data from erosion and some data from Merck, we think that the TIGIT sort of also confirms that this pathway is very exciting. As it relates to human genetics, we still think that's very important in oncology. We've built a synthetic lethal research unit, we've bought Zejula, and demonstrated with the PRIMA study that that's best-in-class PARP, and we're very excited about the pipeline emerging, which is starting in Phase I with the MAP2a inhibitor which we've moved into the clinic with our collaboration with ANDA and we see several other synthetic lethal opportunities moving forward as we expand our relationships with the Laboratory for Genomic Research with Jennifer Doudna and Jonathan Weissman to uncover novel biology to allow us to see other opportunities in that space. So we continue to be very focused on immunology and human genetics with synthetic lethality and believe that should result in a robust pipeline.
Emma Walmsley, CEO
Thanks, Hal. And Keyur, in terms of your second question—big picture, we have been extremely focused over the last few years on shareholder value creation, recognizing that it has been some time since the formation of GSK that we have had the opportunity to make big moves here. We've been tackling deep historic challenges, the first priority being R&D performance and productivity. By the way, prioritizing that in terms of capital allocation investments and transformation of the team including the leadership Hal has just given you, which is a modest approach with some of the headlines on the enormous progress that has already been made. There is always more progress to make, but underneath that has been the reason we do it; so that we can commit to competitive and sustainable growth delivery, seeing us through whatever loss of exclusivity patents we have to digest. Therefore, historic challenges are being addressed in terms of R&D productivity, a real transformation of the competitiveness of our commercial execution that can be clearly evidenced when looking at some of the big launches over the last few years, and a commitment to drive significant growth with that, whether with Shingrix, Trelegy, or just this quarter that we've committed to driving In terms of pipeline transformation, we've driven that with a significant refresh in talent, not just in R&D but across all of our leadership team. All of this takes time, but we are making major changes in all areas, and our goal in June is to make sure that we bring clarity and specificity so the translation into growth outlooks and a step change in performance from 2022 and beyond also answers key questions that investors may have. We have been clear that we expect to update on the specificity of the separation mechanism as well as distribution policy and target payout ratios. So hopefully, that will be a useful session for everybody. We're very happy to run a bit longer if that would be helpful for people and follow on any of the more questions waiting. Thank you.
Operator, Operator
Thank you very much. Your next questions on the line come from the line of Kerry Holford. You are live in the call. Please go ahead.
Kerry Holford, Analyst
Thank you. Two questions, please. For Iain, just on the legal settlement in the quarter and the guidance for the full year. So could you quantify that item in absolute terms and confirm what it relates to? And once that is acknowledged within your guidance for the year, because if it was not then it effectively implies something has worsened since you provided the guidance; is that fair or not? I noted that I think you mentioned that your expectation for royalty income is lower, but perhaps that is part of the offset—so clarity around those items would be helpful. And then secondly, on strategy, I wonder if you can give any more detail on why the EMA issued a negative opinion to the asthma indication. Do you intend to see that line extension in this region? If so, what work do you think will be required? Thank you.
Emma Walmsley, CEO
So, Iain, why don't you go first, and then Luke can give us prospects and plans on Trelegy.
Iain Mackay, CFO
Right. So, Kerry, on legal in the first quarter of last year, there was a provision for ongoing litigation, which was approximately GBP60 million. In the first quarter of 2021, we were successful in terms of a judgment on that litigation, and the provision was reversed; broadly reflected what we were expecting for this year, which was already factored into how we saw the overall guidance playing through. The effect year-on-year was not. We see a bit of more than $100 million in that one. In terms of royal income, as I mentioned in our comments, we sold one part of the portfolio which Dave and the team have been very successful at working on, which was the sale of the stream of royalty income where we saw that particular product was no longer strategically relevant to the Group, and we saw an attractive economic opportunity to do that, which has informed the slightly lower royalty income for the full year. I think we have moved it from GBP350 million to GBP400 million down to GBP300 million to GBP350 million for royalty income for the year; so those are the details on the financial points. I think probably Luke will have more comments on the indications.
Luke Miels, CFO
Yes, I mean, essentially, Kerry, we didn't meet the parameters outlined by the EMA. The impact is not enormous in Europe; right now, asthma patients represent about 5% of our business and growing incredibly quickly at around 12% of revenue. We don't intend to try and resurrect that indication in Europe. We're disappointed, but moving on, focusing on COPD.
Emma Walmsley, CEO
Thanks. Next question, please.
Operator, Operator
Your next question on the line comes from Steve Scala. You're live in the call. Please go ahead.
Steve Scala, Analyst
Thank you. A couple of questions. The release says that at the June meeting, we will get an update on the timing and approach to consumer separation. I'm curious what is there to update us on relative to timing, since the timing seems unchanged? So, are you referring to fine-tuning within mid-2022, or is a very different timing course within the range of possibility? And secondly, a little bigger picture question: Emma, you took over as CEO of GSK four years ago this month. And as was just said, you provided the plan for the path forward at that time. I imagine that things have not gone according to your original plan, particularly relative to the cut to the dividend, pressure to spin consumer, and the pipeline setbacks. So, things seem to have been tougher than expected. Now, you did just say that these are all formidable tasks and take time. But would you attribute the inability to achieve the initial goals as more external obstacles or internal deficiencies? Thank you.
Emma Walmsley, CEO
Thanks, Steve. Thanks. Still one of your questions. In terms of June, you're right, more reconfirmation on the update on timing or if there have been any surprises. We want to ensure that we address questions that have emerged on the mechanism. Regarding the big picture, I can categorically tell you that we did not anticipate in 2017 a global pandemic. If you just look at the trajectory ahead of that and frankly where we were headed—particularly on our Shingrix vaccine, which, let's face it, has taken a slightly unique turn. We believe, for the reasons that Luke laid out, there has been a short-term hit but also other aspects affecting broader business performance. It's hard to conclude from what's happened in the last 18 months, but being a world leader in vaccines well placed with new technology platforms, with good growth opportunity and momentum in approved assets like Shingrix, and a late-stage pipeline coming through in adult vaccination opportunities like RSV and new technologies in infectious diseases, we think we are in an advantageous position. I would not at all characterize our progress due to unexpected pressures; the choice to split consumer was a very active choice that we made upon the announcement of the deal with Pfizer. And we're pleased that's remained firmly on track, with the plans announced well in place. Regarding pipeline progress, if I point to the successes Hal has pointed out, the nine approvals last year, to just how rapidly we are expanding our pipeline, I think it leads to a very optimistic growth outlook. We believe our commitment is to ensure delivery on future performance, and the underlying support is fundamental to our strategy.
Operator, Operator
Thank you very much. Your next question comes from the line of Andrew Baum. You're live in the call. Please go ahead.
Andrew Baum, Analyst
Thank you. I have a couple of strategic questions. First, to David, how long do you anticipate it will take to separate your established products business? We've discussed the possibility of a joint venture with someone like AmTrust to facilitate an exit and alleviate the drag. Is this initiative close to being executed, or might it resemble the consumer separation, which could take around 24 months to disentangle the business units from the individual pharmaceutical segment? Secondly, for Iain, under the assumption of a complete demerger, do you believe GSK's balance sheet is robust enough to effectively tackle the future challenges posed by dolutegravir generics and competing HIV drugs like islatravir?
Emma Walmsley, CEO
So, in terms of your comments on balance sheet—I’m not sure if you are asking for clarification on details on Dave’s side.
David Redfern, Chief Strategy Officer
Yeah, I guess, our Pharma portfolio, Andrew, that's a revenue stream in excess of GBP7 billion with attractive margins, a lot of cash generation. The prospect of a JV to dilute the opportunity of the earnings and cash from that portfolio seems to not make sense, recognizing the downward topline dynamics driven by loss of exclusivity on a couple of important medicines that will work its way out over the next 24 months. I'm not sure it's necessarily the best step forward regarding supporting both profit and cash, and going on to your second question about strengthening GSK's balance sheet. It's not something that's been contemplated, but there's a strong focus from Luke, David, and the team on continuing to refine that portfolio in terms of our geographical presence, where we distribute those medicines, essentially driven by access, and being able to sharpen focus.
Emma Walmsley, CEO
Regarding separation, we confirmed timing—in June—I think will provide greater line of sight on capital for the new GSK balance sheet. I think we will provide further detail on that at that time.
Operator, Operator
Thank you very much. Your next question on the line comes from the line of Graham Parry. You're live in the call. Please go ahead.
Graham Parry, Analyst
Great, thanks for taking my questions. Two more strategic ones, actually. So firstly, the consumer separation has brought more attention to some of the parts' valuation of GSK, which includes differences between vaccines and pharma dynamics and market outlook. Could you talk through the rationale for having those two businesses positioned in the same organization, and potential synergies from having them together? Secondly, do the recent R&D failures accentuate the need to accelerate external business development and licensing M&A or change the focus in the minds of management on the balance of internal versus external R&D sourcing for GSK? Will GSK consider cutting the dividend earlier than the consumer spin to facilitate debt financing M&A that bolsters the pipeline?
Emma Walmsley, CEO
Well, I think, Graham, we've confirmed the dividend for this year, and we've confirmed that we will be implementing new policies that will update from 2022; that's already been stated and committed to. I will let Hal cover anything further he has on our ongoing view that R&D should continue to be supplemented by BD. But let me cover quickly your points on vaccines—absolutely, call to new GSK, not least because scientifically, we are focused on the science of immunology. These businesses are operationally, geographically, completely integrated, so Luke leads the commercial operations for our vaccines in all countries in the world in an integrated way across the rest of the portfolio. Scientifically, we have one development organization, which is helpful from an operating and capital allocation judgment point of view. This is also increasingly relevant when you have such a large portfolio of infectious diseases. When we all know that, as evidenced most recently through COVID, there's a growing focus on both prevention and treatment—and we think about it, whether it's flu, Hep B, and HIV. If you think we are working on both the prevention of and treatment in COVID too, we see increasing opportunities in that direction, as well as the platforms and strategies focused on immunology. As for R&D, Hal, certainly ongoing R&D incrementally strengthens our pipeline, and enhancing BD helps find interesting prospects.
Hal Barron, Chief Scientific Officer
Of course, strengthening the pipeline is a top priority for our company. Our number one priority has been to allocate capital for this, and we have invested significantly in our internal efforts, which has resulted in five new medicines in the past 12 months, and there that many approvals—if you include lifecycle innovation. Business development plays a critical role in this. We've been very active in this space, having done deals with Vir and CureVac recently, and we will continue focusing on finding interesting avenues in the external landscape.
Emma Walmsley, CEO
Thanks. Next question, please.
Operator, Operator
Thank you very much. Your next question on the line comes from the line of Geoff Porges. You're live in the call. Please go ahead.
Geoff Porges, Analyst
Thank you very much. A few quick questions. Luke, you said recovery in Shingrix in the second half of the year, but could you give us a sense of whether you expect that to be the same as 2019's, below 2019 still, or above 2019—which would presumably be real growth? And then, perhaps you could also comment on your average pricing effect in Q1 on the major brands? What was net price? Lastly, related to that, forecasting that is always tough. What are your assumptions about U.S. long-term pricing being incorporated into the five- and ten-year forecast that were provided? In essence, will you be able to grow regardless of what happens to pricing environments in the U.S.?
Iain Mackay, CFO
So, Luke, you might want to talk about net pricing on some brands. On the overall U.S. reform on pricing outlooks, it’s frankly a bit of a fool's errand to try to determine how that may unfold. We will engage with the administration regarding the reform on access and reducing out-of-pocket expenses for patients. We do evaluate those variables and then with that valuation in hand, follow an overall risk assessment regarding top-line growth projections we will share on the 23rd of June.
Luke Miels, CFO
Geoff, I mean, I think Shingrix is broadly similar to 2020 in terms of projections, with some evidence of positive recovery resulting from prior safety concerns. As for pricing, it was as expected; we have some pressure on pricing in Advair, but with good strong pricing trends with Anoro and Trelegy. We did see some pressures around the IL-5s, but we still have dynamic pricing across the rest of the portfolio. Nothing notable, and considering fullness of return certainly prompts optimism on our side for our other long-term expectations.
Emma Walmsley, CEO
Thank you. So, I think we have one final question. Now, I'm sure we'll look forward to having more in coming days, but let's finish with the last question now, please.
Operator, Operator
And your last question today is from the line of Peter Welford. You're live in the call. Please go ahead.
Peter Welford, Analyst
Hi, thanks for letting me in. Just returning to the growth outlook first of all for the next 10 years and five years—just to be clear, is this going to be growth outlooks for both the top-line and margins and also EPS, or how should we think about this? And what degree of flexibility do you want to build into that outlook given, obviously, the 10-year time frame? What could happen regarding your ability to execute on future strategic visions? And finally, on vaccines—can you confirm any of the pathogens that you're working on with CureVac? And could you also tell us a little about perhaps any pre-orders you're seeing for flu vaccines and how that's evolving after a bumpy year last year? Lastly, on Blenrep, curious if you could give us any visibility on the types of patients that you're getting in the U.S. going on that drug and if you could just update us on the timing of the data for GSI this year? Thank you.
Emma Walmsley, CEO
Right. So Luke could you give a quick response on Blenrep please? Hal, on GSI readout, and then we're not going to give any more details on CureVac today. We’ll bring more of that later in the year, and then we'll finish with Iain, please, just to give a little bit more color on the outlook that we mean for our company moving forward.
Luke Miels, CFO
Yes, thanks, Emma. Just to give you the recent flu vaccine pre-books, we're nearing completion across 54 million doses, similar to 2020, just flagging that there may be a revision due out from returns provision as we had a lot of demand last year. So, the comparison will be challenging the Southern hemisphere side looks good. In terms of Blenrep, I think it's off to a particularly strong start. If you look at it in the post-Dara era—solid strong performance at the same point as XPOVIO and Sarclisa. You asked about a typical patient; there is a broad profile. On average, they tend to have previously been on a PI, an IMiD as CD38, and a couple of combos. It's interesting because if you examine that a bit, the average share of patients is about 5% in top-line and about 18% with 7+ lines; but we're actually the leading agent in that 7+ line category, which aligns with our expectations at this point. The dose range is strong; about 185 mg to 90 mg per patient, and we are not seeing many instances of dose splitting, which is a good sign for tolerability and increasing progress into earlier lines of treatment. Remarkably, about one in two oncologists or hematologists in the U.S. have tried Blenrep and the primary reasons that drive them to using the agent relate to the efficacy and the mechanism of action. The main navigation concerns fall lower in context percentages regarding eye exams and logistics associated with deliverables, so I hope that's useful and can draw some encouragement from the broader uptake of the product so far.
Hal Barron, Chief Scientific Officer
Yes, I know we should have further data on the Blenrep data with the GSI combination from the DREAMM-5 study before year end—potentially some early data before that.
Emma Walmsley, CEO
Thank you, everyone. Sorry we ran a little over time. Looking forward to seeing you all hopefully in June. Thank you.
Iain Mackay, CFO
Thanks very much, everybody.
Operator, Operator
Thank you to all our speakers. That concludes your conference call for today. You may disconnect. Thank you for joining, and enjoy the rest of your day.