GlaxoSmithKline PLC

LSE:GSK

Earnings Call Transcript 2020-Q4

[Operator]

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.

[Iain James Mackay, CFO & Executive Director]

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 has been out ill for a couple of weeks, and this is literally her first day back, so she's on listening-mode only today.You should have received our press release and can view presentation on the GSK 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. 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 2 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 expanded fourth quarter R&D update. And with that, I'll hand the call over to Emma.

[Emma N. Walmsley, CEO & Director]

Thanks, Iain. So 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 '21; the successful separation into 2 new companies, with strong performance trajectories in '22 and beyond. 2020 was always planned to be a year of investment in our pipeline and new launches and in preparing to be 2 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've remained 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 for the year, which was set before the pandemic, with reported sales up 3% CER and earnings down 4% to GBP 115.9.I'm especially pleased by the strong commercial execution in our new and specialty products with sales of GBP 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. And 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 have 9 major approvals in 2020, and it was great to see the FDA recently approve our long-acting HIV treatment, Cabenuva.We now have over 20 assets in late-stage development, many of which could be transformational for patients and deliver significant commercial value. These products could all launch before 2026, and we believe more than 10, if successful, have the potential to be blockbusters.And across R&D, we completed over 20 business development deals during the year, strengthening our capabilities with the acquisition of new antibody, mRNA and genetic platforms and technologies, amongst others. We continue to contribute to the COVID response on multiple fronts. I am delighted that this morning, we announced the deepening of our strategic partnership with CureVac and with a new exclusive agreement to research and develop next-generation mRNA COVID vaccines, which have the potential to address multiple emerging variants.In addition, [indiscernible] 100 million doses of CureVac's current COVID vaccine candidate. And this is alongside our work with our other partners on adjuvanted vaccines and we're looking forward to more progress here in the coming months and to data coming very soon on our therapeutics as well as longer-term opportunities for further strengthening of our global leadership in infectious diseases.Building trust with all our stakeholders remains of critical importance. And in November, we set ambitious industry-leading environmental targets to have a net 0 impact on climate and net positive impact on nature by 2030. I was also delighted that last week, for the seventh time in a row, when global health has never been higher on the agenda, that GSK topped the Access to Medicines index for the industry once again.For 2021, we have been clear that this would be the second of a 2-year transition period, with further investment in our pipeline and that we expect a meaningful improvement in operating performance from 2022 onwards. This remains the case, although the short-term disruption from the pandemic to our Vaccines business, as COVID immunization is now prioritized, has impacted our guidance for '21.Assuming that health care systems and consumer trends return to more normal conditions later in this year, we'd expect to see the strength of each of our businesses come to the fore, supporting our high confidence that we'll deliver improved growth and margin expansion from '22.Looking at our priorities ahead of separation, this year, we'll be focused on continued investments in innovation to support sustained long-term growth from 2022 onwards. We expect to deliver further progress in R&D, and I'll update you in June on our plans to advance and commercialize our high potential late-stage assets and the significant value creation we now see as we develop a pipeline based on the science of the immune system, the use of genetics and advanced technologies.Our performance focus is on growth driver execution and completing our Future Ready program to set competitive operations for both companies. In June, alongside our R&D update, we'll set out the positive growth outlook we see for this new biopharma company from '22 onwards, together with our expected capital allocation priorities and a new distribution policy that supports investment in sustainable growth and attractive shareholder returns.On trust, we're committed to retaining our leadership in ESG, in global health and to being a modern employer to attract and retain the very best talent. Never has being a purpose- and performance-driven company mattered more. And ESG will also be a part of the biopharma investor update, and we'll provide news on progress here, alongside that of innovation and performance throughout the year.An investor update for the new consumer company is also expected in the first half of 2022. So I'll now hand over to Iain to take you through the detail of this year's results.

[Iain James Mackay, CFO & Executive Director]

Thanks, Emma. All the comments I make today will be on a constant currency basis, except for 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's 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 of 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 GBP 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% in both sales and adjusted earnings per share. Slide 9 summarizes the reconciliation of our total to adjusted results. The main adjusting items in the year were in disposals, which reflect the disposal of Horlicks and other consumer healthcare brands; In major restructuring, which reflect 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 remeasurement of the contingent consideration liability for ViiV 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 of a slight decline, down [ 1% ] in 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 growth mainly from Trelegy and Nucala, with favorable RAR adjustments benefiting Relvar/Breo.You should note that we will in future be reporting Relvar, along with the smaller Incruse and Arnuity, within the Established Pharmaceuticals, and we'll give you the statement information ahead of Q1 so that you can update models. Moving to Benlysta, sales were up 19%, with subcutaneous formulation up 33%.In Oncology, sales were GBP 372 million, up 62%. Zejula sales were GBP 339 million in the year, up 48%. And BLENREP, which was approved in August, had sales of GBP 33 million. HIV revenues were up 1%. The dolutegravir franchise grew 2%, with the combined performance of Dovato and Juluca more than offsetting the decline in the 3-drug regimens. Luke and David will provide more details on commercial performance shortly.The Established Pharma portfolio declined 15%. Within this, Respiratory was down 15%, reflecting generic competition for Advair/Seretide and Ventolin, plus price pressure for Flovent in the U.S. The rest of the Established Pharma portfolio was down 14%, with COVID-19 impacting performance, particularly in antibiotics.Additionally, we've seen increased government-mandated use of generics in certain markets. We continue to review opportunities for divestments in this portfolio. The pharma operating margin was 24.5% in 2020, and the 150 basis points decrease primarily reflected increased investment in the R&D pipeline, and with the impact of lower revenues largely offset by the continued benefit of restructuring and tight control of ongoing costs.Slide 11 gives you an overview of Vaccines performance with sales down 1% in 2020. Shingrix sales grew 11%, driven by good growth in Germany and China and a stronger performance in the U.S. in Q4. Influenza sales grew 37% and primarily reflected robust demand across all regions, resulting from the strong government recommendations that prioritize flu vaccination during COVID-19 pandemic conditions, together with the reversal of the prior year returns provision in the U.S.Meningitis sales grew 3%, and in the U.S. both Bexsero and Menveo grew market share. However, the Meningitis market share was impacted by the disruptive back-to-school season in the U.S., which resulted in Bexsero sales declining 2%. This was more than offset by growth in Menveo and Menjugate. Established Vaccines were most impacted by the pandemic environment and declined 14%, notably in hepatitis, where the impact of lower demand in older adult populations and travel restrictions was further impacted by the return of a competitor to the market. Our DTPa-containing vaccines and Synflorix were also significantly affected. Partly offsetting this, Cervarix more than doubled to GBP 90 million in China.The operating margin was 38.9% in 2020. The 190 basis point decrease reflected negative operating leverage from the COVID-19-related sales decline and increased investment behind key brands. Turning to Slide 12. 2020 revenues in Consumer Healthcare on a pro forma basis grew more than 4%, excluding brands either divested or under review. Including those brands, turnover declined 2% pro forma. Reported growth was 14%.Oral health grew 6% at CER, including Sensodyne growing double digits, reflecting underlying brand strength and innovation. Vitamins, minerals and supplements grew high teens, driven by increased consumer focus on personal health and wellness and strong commercial execution.There was continued growth in pain relief, driven by the successful Rx to OTC switch for Voltaren in the U.S. and Advil returning to growth. However, this growth was partially offset by weaker performance in Respiratory health, with a weak cough and cold season in Q4.Operating margin for the year was 22.1%, 22.3% at CER, up 30 basis points, benefiting from integration synergies which more than offset the expected significant impact on the margin from divestments in the year. There is no change to our previous guidance for consumer margins of mid- to high 20s from 2022. On Slide 13, we summarize the sales and adjusted operating margin for 2020. Our group operating margin was 26.1%, down 40 basis points on a pro forma basis at CER. Increased investments in R&D, up 6% for the group and up 9% in pharma, along with negative sales operating leverage, was partially offset by ongoing tight control of costs across the group and the continued [ Audio Gap ]Looking at margins on a pre-R&D basis, the increase was 50 basis points on a pro forma basis at CER, which underscores the progress we're making in efficiencies across the group. Moving to bottom half of the P&L, I'd highlight that interest expense [ Audio Gap ] slightly below our expected range, and we expect interest expense to be in the range of GBP 850 million to GBP 900 million in 2021, similar to 2020. The effective tax rate of 16% was in line with expectations. We expect the 2021 tax rate to increase to around 18%, in line with what we've previously indicated, and continue to expect the effective tax rate to step up again over the medium term, excluding any potential impact from changes to U.S. tax policy.And finally, noncontrolling interest reflected Pfizer's share of profits of the Consumer Healthcare JV. We had a good year of positive cash flow performance, delivering free cash flow of $5.4 billion in 2020, up from GBP 5.1 billion in 2019. Key drivers of this year-over-year improvement are set out in the slide.Q4 performance was mainly informed by strong working capital performance. Improving cash flow is a constant focus for our team. We do, however, anticipate lower free cash flow in 2021, informed by less cash from asset divestments, which was particularly strong in 2020, less favorable RAR timing compared to last year, along with continued investment in R&D-focused business development and higher outflows from restructuring, which we will largely complete this year.In 2021, the group will continue the strong progress made during 2020 and delivering our strategic objectives and readying for separation. With regards to turnover for 2021, there is no change to the expectations we previously set out for Pharma and Consumer, with 2020 performance reinforcing our confidence in their outlook.Across the group, our turnover comments assume the health care systems and consumer trends approach normality in the second half of the year. For the full year, we expect flat to low single-digit percentage growth in Pharma revenues, excluding divestments, which will be a balance of continued strong momentum from our new and specialty medicines, largely offset by decreasing revenues in Established Pharma.In Consumer, excluding brands divested or under review, we expect low to mid-single-digit growth, outperforming the market. In Vaccines, the 2021 in-year COVID-19 impact on our portfolio is uncertain. The pace of mass vaccination programs being a key factor, notably in the U.S.Overall, for this business, we expect flat to low single-digit percentage revenue growth. With respect specifically to Shingrix, Luke will provide more detail shortly. But broadly, we anticipate that we'll have strong growth in revenues into the second half of the year and increasing contributions from markets outside the U.S. Across the rest of the Vaccines portfolio, we expect to deliver a similar volume of flu doses, but for sales to be under pressure due to favorable RAR in 2020.We expect Meningitis to be broadly flat, informed by the continued impact of the pandemic, including COVID-19 vaccination programs. And our Established Vaccines portfolio will experience similar pressures in 2020, again largely informed by pandemic dynamics. The key factors that will influence our 2021 outturn in Vaccines, in addition to the pace of deployment of COVID-19 immunization programs, include the trend of infection rates, the extent of recovery in international travel and back-to-school patterns, particularly in the U.S. and how health systems around the world prioritize resources between COVID-19 response and other infectious diseases.Across the 3 businesses, it's worth noting that comparisons to the prior year will be influenced by stocking patterns experienced in 2020, notably in 1Q when turnover grew 10% pro forma and adjusted EPS was up 26% in the prior year. This volatility in comparisons is amplified in consumer, with a weak cough and cold season continuing into the start of 2021. To assist the analysis, we've included in the appendix showing 2020 quarter-by-quarter performance. We'll continue to grow R&D investment in low double-digit percentage terms and expect an effective tax rate of around 18% for the full year.Taking these factors together, we expect a decline of mid- to high single-digit percent in adjusted EPS. For 2021, we expect to pay a dividend of GBP 0.80 per share for the full year. Importantly, our operating performance outlook for '22 and beyond remains unchanged. Our focus on delivering our strategic objectives in 2020 and 2021 lays the foundation for a meaningful step-up from 2022 onwards, with an advancing pipeline, further growth in new and specialty pharma, normalization in vaccines following the short-term [ pandemic ] impact, and ongoing consumer sales growth and margin expansion. Savings from largely complete restructuring programs and resulting synergies will underpin our improved group operating performance. Our biopharma investor update in June will set out details of programs in [ the ] R&D pipeline and key growth drivers, medium-term financial outlooks and capital allocation priorities. We intend to implement a new distribution policy for dividends from 2022, the year of separation into 2 new companies. The new policy will ensure we have the right capital structure for each business and the capacity to invest so that we can deliver growth and long-term shareholder value.We expect to implement the new policy from Q1 2022 and that the distribution will be lower than the GBP 0.80 per share currently paid. The new policy will target a progressive dividend informed by appropriate earnings payout ratios through the investment cycle and will be well covered by free cash flow. And with that, I'll hand over to Luke.

[Luke V. Miels, President of Global Pharmaceuticals]

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 an 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 want to spend a few minutes highlighting some of the important examples. So starting with key Respiratory drivers, which you'll find on Slide 18. Trelegy had a tremendous year, with sales up nearly 60% to over GBP 800 million in just its third year on the market.Trelegy continues to lead the inhaled triple category with COPD in the U.S., Europe and Japan and is growing the overall market. In the U.S., the FDA approval in asthma in September had a hugely galvanizing effect with 2/3 of HCPs recognizing the uniqueness of our dual indication, and we've seen the 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 nearest rival and closing on a 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 1/4 of patients received triple therapy despite an addressable patient population in which up to 2/3 of sufferers are at risk of exacerbation.If I move to Nucala, we had another strong year, delivering close to GBP 1 billion in sales and growth of 30%. Nucala has maintained its category leadership in the U.S. and other key markets based on its precision targeting of IL-5 to reduce eosinophils to normal levels, which differentiates it from other biologics. Looking ahead, we continue to see significant growth opportunities in asthma, given that only 28% of eligible patients in the U.S. currently receive a biologic.In addition, we're confident of extending Nucala's leadership through expansion into other eosinophilic-related conditions, including EGPA, HES and potentially nasal polyps and COPD. Last, but not least, we want to capitalize on our learnings with Nucala and deliver a new level of patient convenience through our novel long-acting IL-5, GSK'294. This potentially transformational asset will be dosed as a convenient subcut injection, once every 6 months, and we are moving into the Phase III this month.With positive in-house data and a validated negative action, we believe it has a high probability of success and the potential to deliver blockbuster sales. Switching on to Slide 19 to Benlysta. We've now seen 9 successive years of double-digit growth, and this is a testament to the unique value this product brings to lupus patients.In 2020, growth of the product was driven by convenient at-home administration with a subcut, which has brought in new patients, and by the success of our IV launch in China. At the end of the year, Benlysta received FDA approval for use in lupus nephritis, which affects around 40% of patients with SLE, and can lead to end-stage kidney disease. And in doing so, Benlysta became the first and only drug to be indicated for both indications. The slide shows that the lupus market is a substantial upside potential as more than 80% of eligible patients remain untreated with Benlysta in the U.S., and of course even more around the world. The number of untreated patients has increased further with the lupus nephritis indication. So we remain very optimistic that this is a major growth opportunity ahead to help these patients. I would also highlight the expanding market opportunity in China, where we've filed for the subcut formulation in the lupus nephritis indication. Taken together, we expect Benlysta will continue to surprise forecasts on the upside.On Slide 20, we continue to make great progress in building our Oncology business. With Zejula, we were able to drive a substantial increase in market share. In particular, we've been very successful in using the FDA approval of PRIMA which resulted in Zejula having the best-in-class label as the only PARP inhibitor for all comers in the first-line maintenance setting.As a consequence, our overall share in this setting continues to grow. In the BRCA-mutant population, we are up to a 27% share. But the real uplift has come in the wild-type population, where we've overtaken Lynparza as the category leader and we now have over 50% share. Again, a direct result of execution on the PRIMA study.Looking ahead, we know there's a significant opportunity to penetrate the market, given that watch and wait is still, unfortunately, being used in the majority of women in the first-line maintenance setting in the U.S. and only 1/4 of patients receive a PARP. We're addressing this through carefully targeted medical education programs and through DTC.Beyond first-line ovarian maintenance, we have a revised development plan in different settings and in other cancer types, including non-small cell lung. In the short term, though, we need to navigate the impact of COVID lockdowns which continues to materially disrupt debulking surgeries and treatment rates. We remain confident on the potential of Zejula. I want to now turn to BLENREP, which we launched in the second half of 2020 for heavily pretreated multiple myeloma patients in the U.S. and Germany. It's still early days, but we are pleased with the solid demand we are seeing, which reflects the high unmet need in later lines of disease. Response from physicians, patients and advocacy groups has continued to be excellent, based on the potent efficacy of the drug in the approved setting and on positive clinical updates in other settings such as we saw at ASH. To date, more than 1,100 ACPs and 700 patients have enrolled in our U.S. REMS program. We're supporting the launch with a highly experienced sales force, and our share of voice is almost at the level of Desolex. We're also focused on the continued development of this practice-changing medicine through alternative doses, scheduling and combinations to improve the safety profile and to potentially extend approval into earlier lines of therapy.Later in the presentation, Hal will discuss the significant potential for BLENREP in the earlier lines of therapy, highlighted at ASH. Consequently, we're optimistic that BLENREP, like Zejula, has the potential to deliver blockbuster-type sales and could be a cornerstone of our fast-expanding oncology business.Shifting to Shingrix on Slide 21. We saw a strong recovery in sales growth to more than 20% in Q4. This was driven by increased wellness visits in the U.S., higher demand in Germany and the phased launch in China. For the year as a whole, Shingrix moved back into the double digits. Critically for the long-term outlook for this key growth driver, we made good progress on our planned capacity expansion. Inventory on hand and our improved production plans for 2021 and beyond should allow us to fully meet demand until our new facility comes online in 2024.At that point, we'll benefit from a further step-up in capacity, amounting to tens of millions of doses over time, supporting our multibillion sales expectations. In the near term, however, we expect to continue with some further disruption in the U.S. The resurgence of the pandemic is already resulting in double-digit reductions in well visits in January, which is impacting our Vaccines business more broadly. In addition, the prioritization of vaccine resources towards COVID-19 immunization is likely to have a significant impact on older adult vaccinations, including Shingrix, especially given the recommended 14-day window either side of mRNA vaccine shots.The slide, you can see, shows a couple of scenarios on how the phasing of Shingrix could be impacted for several months in patients who are receiving COVID vaccines. And of course, we could see similar disruption in other key markets, including Germany and China. I do, though, want to stress that to the extent that Shingrix is impacted, the fact is this is a timing issue, as the underlying demand remains strong. Hence, we're expecting sales to be deferred, not lost. So what does this mean for the 2021 outlook?Well, taken together, we are anticipating broadly similar volumes in the U.S. Shingrix, with growth weighted to half 2 and increasing contributions from markets outside the U.S. Assuming progress towards more normal operating conditions, we expect a significant step-up in Shingrix sales in 2022. And with that, let me now hand over to David.

[David Simon Redfern, Chief Strategy Officer]

Thank you, Luke, and hello, everyone. The HIV business grew 2% in Q4 and 1% for the year. Within this, we achieved a noticeable 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 -- strong commercial execution behind our two-drug regimens 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 $1 billion. 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 at 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 life-saving 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 noninferior 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 2/3 expressed 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 we'll 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 [ these ]. We expect the progressive acceleration in growth, underpinned by the continued expansion of the two-drug regimens, notably for Dovato and the launch of Cabenuva, and in due course, cabotegravir in the PrEP setting. And with that, I will hand you over to Brian to talk about Consumer.

[Brian McNamara]

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 in 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. 97% of Pfizer Consumer Healthcare revenue is now on our system, with 74 markets having transitioned since the start of the pandemic, and 100% of co-locations 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 GBP 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 system 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 remained a standout performer, with Centrum, Emergen-C and Caltrate all up double digits, and our category performed ahead of the market. We also saw a double-digit growth in the final quarter in China and in our retained business in India. E-commerce was strong across all categories, growing around 70% for the year and now at around 6% of sales, up a few percentage points on last year.In key markets such as U.S., China and the U.K., where our e-commerce shares are ahead of this level, we outperformed. Importantly, we grew significantly ahead of the market, gaining overall share. Turning to our power brands, we saw 6 of the 9 power brands in growth, 4 of these brands growing double-digit and with 7 of 9 gaining or holding share. We saw strong performance from our innovation, and examples during the year include Sensodyne sensitivity and gum, which is now in over 50 markets and continues to help drive overall brand share.In the U.S., the Voltaren Rx to OTC switch was a key growth driver, and the brand accounted for 79% of pain relief category growth in the adult pain segment. Finally, our Advil Dual Action launch in the third quarter, the first ever Ibuprofen-Acetaminophen combination, helped Advil return to full year growth. Looking ahead, we have a strong pipeline of exciting innovations for 2021. So in 2020, our portfolio strength helped us deliver over 4% revenue growth, constant exchange rates, excluding brands divested and under review, for the full year.Finally, it's important to note that on the back of all the great integration work to date, we start 2021 with a fantastic portfolio of category-leading brands with a strong geographic footprint, positioned in a sector which is now more relevant than ever. With that, I'll hand it over to Hal.

[Hal V. Barron]

Thanks, Brian, and good afternoon, everyone. Today, I'll spend the next 10 minutes or so summarizing an update I shared at the JPMorgan 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 and STINGRAY to help us identify novel targets with the higher probability of success and a robust life cycle potential.2.5 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 novel 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 collaboration.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 life cycle 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 long-acting IL-5 program that we plan to move into pivotal studies this month. Next slide. This slide summarizes the significant achievements R&D delivered in 2020. During the year, we received 9 major approvals, including the approval of 4 new molecular entities. We delivered positive data on multiple high-value programs, leading to the initiation of 9 pivotal studies. We continued to augment the pipeline through business development with more than 20 deals executed in 2020, including important new collaborations with both VIR and CureVac. The next slide shows a snapshot of our current pipeline of 57 vaccines and medicines, which are focused predominantly on infectious disease, oncology and other immune-mediated diseases.23 of these assets are in Phase I, 12 in Phase II and 22 in potentially pivotal studies, with the vast majority of these assets likely being either first or best-in-class. Based on our current projections, by 2026, we have the potential to launch numerous new vaccines and medicines as well as new indications for existing assets. Given the probability of success associated with drug development, we don't expect all of these assets to succeed and reach patients; however, if all were successful, we believe that more than 10 vaccines in our medicines in our late-stage portfolio could significantly change medical practice and thus have peak annual sales potential in excess of $1 billion, and a number of these assets, such as our RSV vaccine in older adults, could have multibillion-dollar potential. Given time constraints, I cannot discuss all these programs today, but we will have an opportunity to provide more information in June. The next slide shows the significant progress we've made in Oncology, where we now have a development portfolio of 15 potential medicines.We took a smart bet with the acquisition of TESARO, and this was validated by the PRIMA data. As you heard earlier from Luke, we're pleased with the physician response we are seeing to Zejula as we continue to grow market share for this potentially best-in-class PARP inhibitor. I'd like to take a moment to talk to you about Bintrafusp alfa, the TGF beta trap/PD-L1 antagonist and the recent news about the 037 Lung Study. Given an industry average success rate of about 25% for Phase II studies, the high-risk nature of I-O studies, and the high bar we set with the head-to-head study against pembro, Merck's announcement that the study has been discontinued is disappointing, but not completely unexpected.And I still believe this is a smart, though risky, step to have taken. Another I-O program where we made substantial progress is BLENREP, which I'll cover on the next slide. BLENREP is the first approved BCMA-targeted therapeutic and our most advanced immune modulating asset. In addition to blocking BCMA and delivering a potent drug toxin, it has enhanced ADCC activity and induces an immunogenic cell death, both of which we believe are important for its impressive efficacy. As many of you are aware, keratopathy is a side effect that some patients experience when receiving BLENREP, and we are focused on reducing the risk of this occurring.One of the approaches I'm particularly excited about is the novel combination of BLENREP with SpringWorks gamma secretase inhibitor, which inhibits the cleaving of BCMA from the cell membrane. This could result in higher expression of BCMA on plasma cells, which could enable a lower dose to be used and still preserve the impressive efficacy. We should have some preliminary data on this combination from the ongoing DREAMM-5 study by the end of this year. There is significant potential for BLENREP in earlier lines of therapy, and this was highlighted at ASH in December, where compelling data from the Phase I/II ALGONQUIN study in the second-line setting were reported. The key message from this study was that deep responses are being seen with BLENREP when given in combination with Pom/Dex. Across 2 different dose regimens, the combined overall response rate was 88% and there was a 100% response rate in patients who were refractory to an [indiscernible] PI and daratumumab. Additionally, the overall incidence of [ corneal ] events was reduced in the lower dose regimen. These data give us increased confidence in our ongoing second line pivotal DREAMM-7 and DREAMM-8 studies. I'd like now to highlight another potential medicine in our IO Oncology portfolio, our unique first-in-class ICOS agonist antibody called feladilimab. ICOS is a receptor on T-cells that stimulates T-cell expansion. Feladilimab is an IgG4 antibody designed to stimulate and grow cytotoxic T-cells without the depleting effects seen with other antibodies. We are developing our antibody in combination with pembro for patients with the first-line relapsed or metastatic head and neck squamous cell cancer in 2 ongoing Phase II studies, INDUCE-3 and INDUCE-4, both of which, if the interim data is encouraging, will ungate the Phase III component of these studies. INDUCE-3 is enrolling well, and we expect to have data to enable this first interim analysis in the first half of this year. ENTRÉE-LUNG is our other randomized Phase II study looking at overall survival in non-small cell lung cancer patients, which should also read out in the first half of this year. We also intend to share new data from the INDUCE-1 study in various different tumor types by the end of the year. So as you can see, there are a number of upcoming data readouts which will clarify the path forward for this potentially transformative medicine.Now switching from oncology to infectious disease, where we have a world-class pipeline of 30 vaccines and medicines and a market portfolio of 22 vaccines and medicines which had revenue of approximately $16 billion in 2020. A number of these programs have the potential to transform patients' lives, and we plan to cover these in more detail at the June event.These include our antisense compound GSK'836, which may provide the first functional cure for patients with chronic hep B, and gepotidacin, which could be an important new treatment option to combat antimicrobial resistance and potentially be the first new antibiotic in 20 years to treat patients with uncomplicated urinary tract infections and urogenital gonorrhea, and as David mentioned, an impressive HIV pipeline.Lastly, given recent advances in vaccines made during the pandemic, it's important to highlight our exciting early stage Vaccines pipeline that leverages our extensive portfolio of platform technologies, such as mRNA, both non-replicating and self-amplifying, as well as viral vectors and adjuvants. Several of these candidates are actually expected to move into the clinic over the next 18 months. Additionally, as Emma mentioned, we announced today a new agreement with CureVac to develop a next-generation mRNA COVID vaccine, which complements our previously announced collaboration with CureVac on mRNA technology more broadly.Today, however, I want to focus on 2 programs that I'm particularly excited about, our RSV vaccine candidate for older adults and the highly promising COVID-19 antibody VIR-7831. One of the highlights of 2020 was the exciting Phase II data we shared on our RSV vaccine candidate for older adults and mothers at the ID Week in October. Both vaccines are based on our combinant subunit prefusion RSV antigen, which is believed to trigger the required immune response.For older adults, we combine this with our proven AS01 adjuvant to enhance the immune response. Phase II data in older adults showed our vaccine induced a near-tenfold increase of protective antibodies. Importantly, T-cells were boosted to a similar range to that observed in younger adults, given non-adjuvanted vaccine. And importantly, the vaccine was well tolerated. Clearly, this is highly encouraging data, and we expect to move into Phase III this month and anticipate receiving initial pivotal data in the second half of 2022.Vaccinating the elderly against RSV represents a major unmet medical need with RSV infection resulting in over 170,000 hospitalizations and unfortunately, 14,000 deaths a year in people over 65 in the U.S. alone. Not only could this vaccine have profound clinical benefit, but we also believe it represents a significant commercial opportunity. We have also been active in the search for solutions to the COVID global pandemic, and I want to focus today on the VIR-7831, which we, along with our partners at VIR, believe has the potential to be a best-in-class antibody for COVID. This is due to 3 unique characteristics. First, this is a very potent neutralizing antibody. And by binding to a unique and highly conserved epitope, it is expected to confer a high barrier to resistance.2 recent publications have supported this hypothesis, which we believe could become extremely important given some of the recent reports of emerging mutant strength. Second, this antibody was designed to have increased effector potency, potentially allowing for greater efficacy. And this is in part why the NIH chose it for the ACTIV-3 in-hospital study.And finally, VIR-7831 has been engineered to have an extended half-life with the so-called LS mutation, which should enable us to observe efficacy at a lower dose, possibly enabling intramuscular dosing.We have a number of ongoing and planned studies with VIR-7831, including the recently announced BLAZE-4 study in combination with Lilly's CoV555 antibody, which we expect data from in the first half of this year. Before I move on to my last slide, I would like to make a comment about our randomized Phase II study called OSCAR, a trial evaluating otilimab, our anti GM-CSF antibody as a potential treatment for patients with severe COVID-related pulmonary disease. The pathophysiology that underlies severe COVID is only just now being unraveled. The emerging science supports a maladaptive innate immune response associated with actual increased GM-CSF expression, particularly in older patients where COVID-19 is particularly severe. We remain cautiously optimistic that our Phase II study, which will read out this quarter, could demonstrate a benefit in patients whose disease is driven by GM-CSF, enabling us to move to Phase III with this potentially important medicine.Now moving to my final slide and our key catalysts for 2021. This year, we've already received U.S. approval for Cabenuva for the treatment of patients with HIV. Later in Q1, we could have data on the pivotal study of VIR-7831 and the Phase II data with otilimab. In Q2, we should have the feladilimab data, I referenced earlier, and in the second half of the year, more data on BLENREP as well as data on daprodustat.I'll close by reiterating that I believe we have made significant progress over the last 2.5 years in building a high-value, sustainable R&D pipeline, and we expect to strengthen this further with continued delivery in 2021. And with that, I'll hand it back over to Emma.

[Emma N. Walmsley, CEO & Director]

Thanks, Hal. So to summarize, 2020 was a year of great progress as we approach separation into 2 new companies, and we remain fundamentally on track to deliver all our strategic priorities. Our pipeline is stronger, our commercial [Audio Gap] is sharper, our cost base leaner and our confidence higher in our ability to deliver sustainable long-term growth post separation into 2 companies. In terms of our priorities for the year, we will retain our execution focus on innovation and performance and expect another year of investment behind our pipeline and [Audio Gap] launches.We'll continue to work on optimizing our cost base across the group and setting up the consumer business as a stand-alone entity. And with our 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 2 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 from them now as we prepare for our very exciting future. With that, operator, the team on the line is ready to take questions.

[Operator]

So your first question comes from James Gordon of JPMorgan.

[James Daniel Gordon, Senior Analyst]

James Gordon from JPMorgan. Two questions, please. The first question was about Vaccines and the CureVac deal and mRNA vaccine. So the release says as well as looking at COVID-19, you're also looking at other Respiratory vaccines. So could that include something like RSV, for instance? And maybe more generally, how are you thinking about vaccines 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 threat to GSK's existing sort of protein-based Vaccine business? And is it also a big opportunity for GSK? So that would be the first question, please.And then the second question was about the EPS growth rebound in 2022. So I've seen you've guided to a meaningful improvement in revenues and margins, but the question is, how meaningful could the rebound be in '22? So if Vaccines rebound and there's some catch-up, and the rest of the business is doing better and OpEx growth slows, could '22 be a year of double-digit EPS growth? Or could '22 earnings be above 2020 earnings power? How should we think about that, please?

[Emma N. Walmsley, CEO & Director]

Thank you very much, James. So look, 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. And 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 after this, James.

[Roger G. Connor, President of Global Vaccines]

Yes, James, thanks very much for the questions. Just 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. And we'll be looking at combinations and certainly, looking at the flu [ asset ] that you referenced as well, is there a 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've just announced today to a very strong strategic relationship already, bringing together 2 companies, CureVac with their platform and us with the technical expertise and scale we have got, really, that we think is going to make a difference.And 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. So mRNA is a proven platform, and it is one that we see as a real strategic strength of ours. And applying it to COVID brings breadth of coverage, we think, through 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 on 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 non-replicating mRNA. So we've got very strong optionality here as well. We see far more opportunity than risk. I would never be complacent. But from an mRNA perspective, it can't be applied to all disease areas. So when we add this, we think it really complements our technology portfolio, when you add up the viral vectors, add up the 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. And you just have to look at our pipeline, you look at our therapeutic hepatitis B vaccine, it's an example of combo of 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.

[Emma N. Walmsley, CEO & Director]

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 impact 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 and the medium term. But Iain, I don't know whether you want to add any more kind of details?

[Iain James Mackay, CFO & Executive Director]

No, I think we'll certainly provide a lot more detail in terms of what supports our optimism around the outlook for '22 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 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, and the 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 topline but expanding growth in adjusted EPS from '22 onwards.

[Emma N. Walmsley, CEO & Director]

And the only thing, because I think Luke cut out, from Australia, exactly the moment when he was [ giving precision ] on the Shingrix outlook. So I just repeat what was said that we really do see the impact on Shingrix being about a deferral of sales, and we've done -- made great progress in manufacturing capacity. But our expectations 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 a contribution from other countries ex U.S. before we then see, assuming a return to normal -- health -- operating systems, some good growth in -- a good strong growth in '22. Next question, please, while the phones get switched off at this end. Apologies. Next question, please.

[Operator]

And your next question comes from James Quigley from Morgan Stanley.

[James Patrick Quigley, Equity Analyst]

James Quigley from Morgan Stanley. Just on the -- for the first question, I'd love to get your thoughts on any of the other levers or mechanisms in order to recognize the cash flow to be able to invest in Pharma innovation. I mean, clearly, the dividend cut is going to unlock some cash for you to invest. 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 this year or in 2021? Or is that sort of a beyond strategy? And then you note the CureVac collaboration or the extended collaboration this morning. You've got lots of collaborations, as Roger highlighted, in other areas. But what about mRNA more broadly? How are you sort of taking the earnings from your Vaccines work and looking to apply that into immunology, immuno-oncology and sort of use mRNA in the broader sense as a therapeutic?

[Emma N. Walmsley, CEO & Director]

Right. Well, in terms of divestments, the short answer is yes. I'll ask Iain to comment quickly on the broader portfolio. We are 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 benefit of the new biopharma company, being focused on driving strength in 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 R&D team.

[Hal V. Barron]

Yes. Thanks, Emma. Yes, James, look, 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 actually, their GBP 1 billion net revenues in that regard -- net 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 and 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 on that as we make progress. I think it would 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.But 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. And 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 2 years, but as ever, more to be done in that area.And 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 2 new companies going forward. And you will recall from earlier conversations that there is a significant deleveraging 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.

[Emma N. Walmsley, CEO & Director]

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

[Hal V. Barron]

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's 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 in others, the other platforms that I mentioned.So 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.

[Emma N. Walmsley, CEO & Director]

Thank you. Next question, please.

[Operator]

And your next question comes from Laura Sutcliffe from UBS.

[Laura Sutcliffe, Equity Research Analyst]

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 setup? Or is there any scope to grow again beyond this year? And 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? And perhaps you could give us a sort of picture of what market access is looking like over there as well?

[Emma N. Walmsley, CEO & Director]

Okay. Well, let's come to David about Cabenuva because this really is a very important pioneering medicine 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. So we're really looking forward to that. But as you've said, it is a new kind of paradigm in behaviors in a not simple environment.On flu, I mean, I think Roger alluded to this as well, which is -- well, Iain covered it in terms of the forecast, which you [ Audio Gap ] picked up. 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 that the -- if your question underlying that is old technology versus new -- and I don't think we should walk away and think mRNA is going to be the solution to all vaccines, as Roger said, it really is a -- there are some disease areas it's not relevant. There are others that'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 plans, but more of that later. Let's come to David on Cabenuva, plans and access questions.

[David Simon Redfern, Chief Strategy Officer]

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., the first oral lead-ins, and then the injectable will be shipped in the very near future. And 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, 2/3 of HIV patients have expressed interest in long-acting treatment. We saw from the clinical trials, the recruitment went very fast and patients wanted the -- 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 that, for all sorts of different reasons, compliance, but often the stigma and the emotional burden of taking daily oral pills, want access to Cabenuva. So we are launching. As always, it will be a build. I mean, there are -- there is some setup 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 the early adopters.We have to go through reimbursements, as always, with different formularies and so forth. That normally takes a quarter or so, but nothing particularly unusual here versus any other launch. So we will be launching, it will build momentum, and in the very near future or in the next few weeks, we will also file in the U.S. for the 8-week data, so every 2 months, based on the 8-week data that we've already got, and that will go in. So we're really excited to get going with Cabenuva and we know patients are waiting for it.

[Emma N. Walmsley, CEO & Director]

Thanks, David.

[Operator]

And your next question comes from Geoffrey Porges from Leerink.

[Geoffrey Craig Porges]

So 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. And 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. So 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 in developing a COVID antibody despite that outlook. So could you help reconcile those signals? And particularly, you've mentioned these variants, and I think there's near panic about them now. Do you think that the so-called South Africa variant with the triple mutation at the receptor binding domain is a terminal adaptation of the virus? Or do you think that this is going to be a whack-a-mole, every 6 to 12 months the virus is going to mutate to an immune-escaped variant that we'll have to continue to iterate against?

[Emma N. Walmsley, CEO & Director]

So, 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 a large developing markets -- that healthcare operating systems return to kind of 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 variance in that will depend on the pace of that, the infection rates. At the same time, and Hal should certainly comment on this scientifically and epidemiologically, that the -- it is clear that this virus is continuing in the U.K. 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, the degree of protection on certain mutants today. 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 of vaccination anyway. Hal?

[Hal V. Barron]

Yes. Thanks, Geoff. 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 from, 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 that was binding to an epitope that we believed was very unlikely to mutate because of how it discovered through being both observed and effective in SARS-CoV-1 patients but also highly neutralizing in the current COVID-19 epidemic. So, 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, the combinations with the Lilly antibody should mutations emerge even more robustly than we expect. And of course, from the vaccine perspective, given these mutations, whether it becomes another pandemic or, more likely, an endemic sort of state, with the multivalent mRNA vaccine potential that we have at 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 with severe pulmonary COVID symptoms are GM-CSF mediated. So it's a bit of a 3-pronged, maybe even 4-pronged approach, and I think it's been relatively consistent from the beginning.

[Emma N. Walmsley, CEO & Director]

Thanks.

[Operator]

And your question comes from Graham Parry from Bank of America.

[Graham Glyn Charles Parry]

So first one's just going back to -- a follow-up from James Gordon's question at the beginning, just about the recovery rate into 2022. So you're flagging the '21 hit from COVID as temporary and then strong recovery in 2022. And if you look at the consensus EPS at the moment, it's about 120p, so that would be about 20% EPS growth in 2022 over what your guide is implying for 2021.So could you help us with your level of comfort with where that is or perhaps which variables consensus should be thinking about for the 2022 forecast. And then secondly, you talked about giving dividend policy for the biopharma 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?And when you're saying about factors that go into -- also when you think about having an appropriate dividend through the cycle, can you just help us understand what factors go into that? So are you benchmarking against other companies, and which ones would you consider to have an appropriate dividend policy?

[Emma N. Walmsley, CEO & Director]

Yes. Okay. 2 important questions. Iain, do you want to pick up both on outlook and clarity of what's coming on dividend or distribution policy versus dividend value?

[Iain James Mackay, CFO & Executive Director]

Absolutely. So 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 [Audio Gap] we expressed at 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 saw -- that we see for 2021 in our Vaccines business, [Audio Gap] 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, it remains very much on track.And I think 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 Vaccines business beyond the impact of COVID-19 for all the reasons that Emma and Roger have set out.And we'll -- 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 and 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 health care company post separation. But what we will do are 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, appropriate, robust coverage from a free cash flow perspective and, importantly, the propensity to grow from a point at which we reset it in 2022. So 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 stand-alone to be less than they presently are today. But importantly, they have the propensity to grow and be progressive dividends from that point onwards. So 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.

[Emma N. Walmsley, CEO & Director]

Yes. Fantastic. And hopefully clear for everybody.

[Operator]

And your next question comes from Jo Walton from Crédit Suisse.

[Jo Walton, Managing Director]

I have 2 questions. If we look at the guidance for 2021, at the sales level, at the divisions flat to growth. At the group level for earnings, it's mid- to high single-digit decline. There's clearly an increase in costs 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. So 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 GBP 3 billion-plus portfolio that you have?

[Emma N. Walmsley, CEO & Director]

Okay. Great. Thanks, Jo. And Iain will add more color to this, and I think particularly on the Established Products dynamic. Although I would repeat, we are looking continually at the portfolio there, and that's obviously where we do target sort of selective divestments too. The headline is, 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 a EPS outlook. And the only difference on where we were previously is the Vaccines contribution to total growth is just quite different than we might previously have expected, although, as just to keep reiterating, that is a short-term [ Audio Gap ] you 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 [Audio Gap]. But Iain, do you want to just -- I don't know if there's anything I missed on the guidance?

[Iain James Mackay, CFO & Executive Director]

Yes. I think that 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 through effect on margin, as you can well imagine, and then the continued double-digit investments in R&D and strength in the pipeline a key focus, and an effective tax rate of around 18% being a step-up to 2 percentage points from this year are the key factors that translate from sort of 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 on and active on a number of transactions in the Established Pharma portfolio. We obviously aren't going to comment in the detail on either which parts of that portfolio, but it is an area where with Luke and David, we spent 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.So particularly when we get to a 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 what -- 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, I feel probably a little bit more muted than 2019 -- 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. But 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, 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.

[Operator]

And your next question comes from Louise Pearson from Redburn.

[Louise Hinds Pearson, Research Analyst]

Firstly, for Luke, on daprodustat with data due later in the year, and just given some recent developments in the space, could you remind us of how you're thinking about that asset and the options you might have on the table should the trials read out favorably? And then one for Roger on the RSV older adult program. Does the Phase III design assume a pre-COVID incidence of RSV [ next into ], i.e., is there a risk to the program that social distancing effects persist to some degree? Meaning that there's less RSV going around and maybe a signal might not be seen?

[Emma N. Walmsley, CEO & Director]

Okay. So straight to Luke and then Roger.

[Luke V. Miels, President of Global Pharmaceuticals]

Sure. Thanks, Louise. So increasingly positive about daprodustat for a couple of reasons which I'll go through now. So just as background for everyone, we've got 5 studies, about 9,000 patients, 2 of them are MACE studies, and they're 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 sizeable population. I think what's changed, if you go back, say, versus 24 months ago or even 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 the 19th of March this year. Our assumption is that they get non-dialysis and dialysis. Vadadustat is in Q3 '21 with their PDUFA, and our assumption is that they only get dialysis, if approved. So with our timeframe towards the end of the year, we expect to get non-dialysis and dialysis. So a competitive profile. And I think the third thing is we've seen the [ collapse ] in Japan, launch different labels that our partner has actually got 42% market share in a 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.

[Emma N. Walmsley, CEO & Director]

Thanks, Luke. And then over to Roger on RSV, I know we're targeting a readout in the second half of '22, anything to add? And then we'll come to the last question.

[Roger G. Connor, President of Global Vaccines]

Yes, exactly. I think we're obviously watching this very carefully in the trial design. Just to reiterate, we think there's a major opportunity in RSV 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 at the population, geographies and numbers that we want to make sure 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 sort of 6 to 9 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.

[Emma N. Walmsley, CEO & Director]

Thanks, Roger.

[Operator]

And your last question comes from the line of Andrew Baum from Citi.

[Andrew Simon Baum, Research Analyst]

Emma, the question won't come as much of a surprise given our research, but you've outlined the separation as most likely taking place as a demerger. Given the demand from GSK Pharma to future-proof their outlook, particularly being aware of the dolutegravir [ capitalize ] of their loss of exclusivity. Why not a partial IPO in order to increase your firepower for M&A? Is it because the tax considerations are so onerous that it makes this less attractive? So if you and Iain could comment on that, that would be interesting.And then a question 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 6 months that all patients who had a response have maintained their response. Maybe you've updated into them. But if you could update this further, that would be helpful in just thinking about whether we're seeing additive or synergistic assets be here in the -- [ ahead and accessing ].

[Emma N. Walmsley, CEO & Director]

Thanks, Andrew. So we'll come to Hal in a second. I mean you set the mechanism for separation in the contract -- 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 prospects of our Vaccines portfolio and developing a strong pipeline, including in long-acting in HIV and all of that will bring more visibility of -- 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 deleveraging 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 where we want to give a holistic view of this new companyits correct 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 and in an ongoing dialogue with our partners, really thoughtful about what's in the best interests of shareholders, and we'll confirm the specifics of that later in the year. And before I hand to Hal on ICOS, anything that you would add to that?

[Luke V. Miels, President of Global Pharmaceuticals]

No. That's it, Emma.

[Emma N. Walmsley, CEO & Director]

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

[Hal V. Barron]

Thanks, Andrew. We're -- we have a lot of catalyst events for the ICOS program in the next 6 months, as I mentioned, the INDUCE-3 interim analysis, the ENTRÉE-LUNG randomized Phase II 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. So I don't want to comment on any numbers yet. But as I mentioned, we're excited about the data readouts that what we'll have for those 2 programs. And we'll share more of that data with you soon.

[Emma N. Walmsley, CEO & Director]

Thanks, Hal. And a big thank you to everybody for the slightly extended discussion today. We look forward to further conversations actually, some today and tomorrow and in the weeks and months ahead for a very exciting next 18 months for GSK and future 2 new companies. Thank you. Have a good day.

[Operator]

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.