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Earnings Call: Q3 2020

Oct 28, 2020

Operator

Good afternoon, ladies and gentlemen, and welcome to the analyst call on the GSK third quarter 2020 results. I will now hand over to Sarah Elton-Farr, Head of Investor Relations, who will introduce today's session. Please go ahead, Sarah.

Sarah Elton-Farr
Head of Investor Relations, GSK

Thank you. Good morning and good afternoon. Thank you for joining us for our Q3 2020 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 investor section of the website. Before we begin, please refer to slide two of our presentation for our cautionary statement. Our speakers today are Emma Walmsley, Iain Mackay, Luke Miels, David Redfern, and Brian McNamara. Hal Barron and Roger Connor will join us for Q&A. We request that you ask only a maximum of two questions so that everyone has a chance to participate. With that, I will hand the call over to Emma.

Emma Walmsley
CEO, GSK

Thank you, Sarah. Welcome everybody to today's call. I hope that you are all keeping well. 2020 continues to be an extraordinary year. GSK has shown resilience and agility in tackling the challenges while maintaining focus on our strategic goals, which remain firmly on track. We've continued to strengthen and advance the pipeline. In July, as mentioned at Q2, we received approval for RUKOBIA in HIV. This quarter, we've also had first approval and launches for BLENREP in multiple myeloma, for TRELEGY in asthma, and new indications for NUCALA. We've delivered positive data on our RSV candidate vaccines and GSK3228836 in Hep B. Plans to progress these programs are underway. Both represent major opportunities for healthcare impact and have the potential to be significant future growth drivers.

We also initiated three major pivotal studies in meningitis vaccines, second-line multiple myeloma, and with our Vir antibody in COVID-19, a very exciting program you're going to hear more on later. There have been some short-term pressures as a result of the pandemic, especially in vaccines early in the quarter, our performance fundamentals continue to strengthen, and we're very confident our vaccines portfolio and pipeline will drive growth for years to come. Brian will update you in more detail, but the momentum we're building in our commercial execution is driving encouraging growth across our new products, setting the course for strong future performance. This has also been a quarter of disciplined cost control, as we've made substantial progress on both our consumer integration and company separation programs.

We continue to deliver efficiency in our support functions, further simplify our supply network, and have achieved an important milestone on building one development organization in R&D for pharma and vaccines that will improve agility, decision-making, and scientific collaboration, as well as our cost base. Our pipeline includes several COVID solutions, and we remain committed to building stakeholder trust as we deliver them. We have in place supply agreements with multiple governments for our partnered adjuvanted COVID-19 vaccines and have pledged to maintain our focus on safety and global access. Turning to the quarter, strong performance from our future growth drivers, combined with a focus on cost, has offset the ongoing pandemic impact. We've delivered margin and earnings growth this quarter and expect to deliver within our earnings guidance range for 2020. All numbers referenced are on a constant currency basis.

In pharma, we're very encouraged by the strong performance of our new and specialty products with sales up 12%. This was offset by a decrease in established pharma of 18%, and we'll go into that in more detail in a minute. The greatest impact of the pandemic has been in our vaccines business, where sales were down 9% in the quarter. However, we're encouraged by the accelerated recovery towards pre-COVID level of immunization as the quarter progressed and a strong performance in flu up 21% year to date. Sorry, up 21% in the quarter. Year to date, SHINGRIX sales are up 6%. In consumer, we continue to reshape the portfolio and pro forma growth in our ongoing business was 3%, driven by vitamins and oral health. Overall, we're gaining share and our power brands are performing strongly.

Group-adjusted operating margin for the quarter was 30.8%, with the impact to vaccines more than offset by tight cost control and the realization of restructuring benefits, with SG&A down 10% pro forma, while we've continued to invest in our pipeline and our new product launches. On a total basis, earnings per share were GBP 0.25, and adjusted earnings per share were up 1% to GBP 0.356. Before I hand over to Iain, I'd just like to remind you of the great progress we're making on our portfolio of COVID solutions. Our aim is to develop multiple adjuvanted COVID-19 vaccines, and we now have three different vaccine collaborations in the clinic that could move to pivotal studies by the end of the year. We also have two exciting therapeutic approaches in clinical studies through our collaboration with Vir, which Luke will speak to later, and our GM-CSF antibody, otilimab.

Now to Iain with more detail on the quarter.

Iain Mackay
CFO, GSK

Thanks, Emma. All the comments I'll make today will be on a constant currency basis, except where I specify otherwise, and I'll cover both total and adjusted results. On slide nine is a summary of the group's results for Q3 and the year to date. In Q3, turnover was down 3% CER. Adjusted operating profit was GBP 2.7 billion, up 4% CER.

Total EPS was GBP 0.25, down 9% CER, and adjusted EPS was GBP 0.356, up 1%. In the year to date, turnover was GBP 25.4 billion, up 4% reported, down 2% pro forma. Adjusted operating profit was GBP 7.1 billion, up 3%. Total EPS was GBP 1.02, up 55%, and adjusted EPS was GBP 0.926, down 4%. We delivered GBP 2.3 billion free cash flow in the year to date. In the quarter, there was a 5% headwind on sales and 9% in adjusted EPS from currency movements. Slide 10 summarizes the reconciliation of our total to adjusted results. The main adjusting items in the quarter to highlight are major restructuring, which reflects continued on-track progress on the Consumer Healthcare integration and transformation and separation activities. In transaction-related, within which the main contributor was a charge relating to the remeasurement of the contingent consideration relating to ViiV Healthcare.

The main component within this was an increase in our forecast for cabotegravir PrEP, following the very strong clinical data that we shared earlier in the year. Comments from here onwards are on adjusted results on a constant currency basis, unless stated otherwise. Slide 11 summarizes the pharmaceuticals business, where overall revenues were in line with expectations, down 3% in Q3 and down 1% in the year to date. Excluding established pharma, revenue grew 12% in the quarter and was up 12% in the year to date, reflecting our strong commercial delivery. Respiratory was up 26%, with continued strong growth from TRELEGY, Relvar, BREO, and NUCALA. BENLYSTA was up 13%, extending its double-digit growth after more than nine years on the market. In oncology, ZEJULA sales were GBP 92 million in the quarter, up 47%, reflecting excellent commercial execution.

We remain very excited by the prospects of both ZEJULA and BLENREP, which launched in the quarter. Our new products continue to perform strongly, and Luke will comment on these momentarily. HIV revenues were flat, with the dolutegravir franchise up 1%, with very strong performance from DOVATO. The established pharma portfolio declined 18%. Within this, respiratory was down 18%, reflecting generic competition for Advair, Seretide, and Ventolin, plus accelerated brand erosion of Flovent in the U.S. The rest of the established pharma portfolio was down 19%, with COVID-19 impacting performance, particularly in antibiotics. Additionally, we've seen increased government-mandated generics in certain markets. For the current year, we expect the total established portfolio to be down mid-teens. Next year, we would expect the established portfolio to revert to its historical norm of mid to high single-digit decline, and we continue to review opportunities for divestments in this portfolio.

Pharma operating margin was 28% in Q3. 470 basis points increase reflected a favorable product mix, a benefit in the quarter from the recognition of pre-launch inventory and approval of BLENREP within R&D. Favorable comparison to 2019 pertaining to non-recurring manufacturing write-down and legal settlements. Tight control of costs and benefit of restructuring actions. These were offset by increased investment in new product support in targeted priority markets, and in R&D focused mainly on oncology and COVID-19 programs. The year-to-date margin was 26.3%. Slide 12 gives you an overview of vaccines performance in Q3, with sales down 9% driven by adverse impact of the pandemic. SHINGRIX sales were down 25%, reflecting lower adult wellness visits in the U.S., particularly through July and August. However, by the end of Q3, SHINGRIX weekly US prescriptions reached similar levels to the same time last year.

SHINGRIX revenue has grown 6% year to date. We've put measures in place to support further growth through Q4 and beyond. Recent trends are encouraging and demonstrate the strong underlying demand for this vaccine. We continue to make progress on expanding supply capacity. Flu vaccines performed well, with revenue up 21%, primarily reflecting strong execution on supply and sales. We expect the increase in flu immunizations, particularly amongst older adults, to support further recovery in SHINGRIX performance. The meningitis portfolio grew 1%, with the disrupted back-to-school season in the U.S. affecting MENVEO performance. In established vaccines, declined 15%, reflecting lower demand due to the pandemic environment, particularly in hepatitis, as expected. The operating margin of 44.2% was 500 basis points lower, primarily reflecting the negative operating leverage from COVID-19 related sales decline and investment behind key brands such as SHINGRIX.

In the year to date, vaccines revenues were down 7% and adjusted operating margin was 40.7%. Turning to slide 13, Q3 revenues in consumer healthcare on a pro forma basis were up 3% excluding brands either divested or under review. Including those brands such as Horlicks, turnover declined 6% pro forma. Reversal of the Q2 systems cut over stocking benefited impacted overall growth by around two percentage points. Oral health grew 5% at CER, with Sensodyne up 7%, driven by strong global commercial execution. The pandemic has had a sustained positive impact on vitamins, minerals, and supplements, which grew 18%, driven by increased consumer focus on personal health. This growth was partially offset by weaker performance in respiratory health with a lower cough and cold season so far, and in pain relief informed principally by Advil market share.

The Rx-to-OTC switch of Voltaren in the U.S. is performing very strongly. Operating margin for the quarter was down 90 basis points year-on-year, mainly reflecting the impact of divested brands and increased brand investment, partially offset by synergy benefits from the Pfizer integration and tight control of costs. There's no change to our previous guidance for consumer margins. Year-to-date, consumer revenues were flat pro forma and up 6% excluding the impact of divested or under review brands. Pro forma adjusted operating margin was 23.8%. Brian will provide more detail on the consumer healthcare performance and an update on the business shortly. On slide 14, we summarize the sales and adjusted operating margin for Q3. Our group operating margin was up 240 basis points on a pro forma basis. Lower costs across the group offset reduced sales operating leverage, which was mainly in vaccines.

Across the company, we are beginning to realize restructuring benefits from programs announced earlier this year. We continue to manage operating costs very tightly and have realized significant savings in categories such as T&E. During Q3, in SG&A, we realized a one-time benefit from restructuring of post-retirement benefits and the non-recurrence of high legal costs from Q3 2019. Our pipeline progress remains firmly on track with pharma R&D year-to-date spend up 6%. The lower R&D spend in the quarter was the result of a benefit from the recognition of pre-launch inventory upon approval of BLENREP. Comparably lower spend related to niraparib and dostarlimab following their filings at the end of 2019, plus the realization of transformation savings, synergies, and efficiencies.

This was partly offset by increased investment in the progression of key assets such as BLENREP, ICOS, otilimab for rheumatoid arthritis, and two key COVID programs, being otilimab COVID and the Vir antibody. R&D in vaccines and consumers slightly down in the year to date. With the realization of noted transformation synergies and savings, we now expect R&D for the group to increase mid to high single digits for the year. All our pivotal programs are on track. Any COVID-19 related delays initially experienced now recovered, with the exception of gepotidacin. We've included the analysis covering the year-to-date information in the appendix. Moving to bottom half of the P&L, I'd highlight that interest expense was GBP 197 million, mainly reflecting lower debt. The effective tax rate of 16.8% was in line with expectations. We still expect a full-year effective tax rate of around 16%.

Finally, non-controlling interest reflected Pfizer's share of profits of the consumer healthcare JV. We've delivered cash flow of GBP 2.3 billion in the year to September. The reduction primarily reflected higher dividends to non-controlling interests and Advair exchange impacts, partly offset by lower seasonal increase in trade receivables, beneficial timing of payments for returns and rebates, higher proceeds from disposals of intangible assets, and improved operating profits. As we indicated at Q2, we expect free cash flow to be lower in the second half of 2020 than the first half, and we still expect cash flow for the year to be a step down from 2019. We closed the quarter with strong cash balances, have an effective approach to working capital management, and maintain access to extensive undrawn committed facilities. We set our guidance range of -1% to -4% CER adjusted EPS in early February this year.

I think it'd be fair to say that quite a lot has happened since then, but I'm pleased that the group has responded with agility, and we're still on track to deliver within this guidance range, albeit at the lower end. The performance for pharma and consumer so far this year is in line with where we expect it to be, with good commercial delivery in our new and specialty products in pharma and our power brands in consumer health. We're encouraged by the vaccines business recovery through the quarter with a stronger performance in September, which has continued so far in October compared to a year ago. In vaccines across the age categories, this recovery is mostly complete in pediatrics, while slightly slower in adolescents informed by the return to schools disruption.

In older adults, the increasing immunization rates and uptake of SHINGRIX is encouraging and demonstrates strong underlying demand. Achieving our guidance does depend on sustaining this recovery of adult immunization rates, particularly in SHINGRIX. We continue to make good progress in improving supply capacity for SHINGRIX ahead of our new facility coming online, and we'll update you on the details behind this in Q1 next year. There are no change to our capital allocation priorities. We continue to advance the pipeline, as noted by Emma earlier. We're making great progress with the integration of the Pfizer consumer business and advancing the transformation across all aspects of GSK and are confident in our preparations for the separation. As noted in our earnings release, we've declared a GBP 0.19 quarterly dividend in line with expectations set out earlier this year. With that, I'll hand over to Luke.

Luke Miels
CCO, GSK

Thanks, Iain. Hi, everyone. As you know, we've been working hard on our commercial execution to ensure that we're competitively resourced with a particular focus on new product launches in our key markets. The changes we've made are now starting to pay off. Sales in our growth areas of respiratory, HIV, immunoinflammation, and oncology were up 12% this quarter to GBP 2.5 billion. Changes we've made include updated HCP engagement policies and sales force incentives to allow us to compete more effectively and responsibly in the key markets where we're driving growth. We're also winning share of voice with strong acceleration of our digital capabilities as well as increased face-to-face engagement where possible.

Though the lockdown restrictions have, as expected, impacted on some of our portfolio, especially established pharma, we've taken the opportunity presented by the new ways of working to amplify our digital presence, complementing more traditional approaches very successfully. With these measures and the right investment, we are seeing great momentum across our new product portfolio, which we expect to build further in the coming quarters as we bring our pipeline assets to market. Starting now with NUCALA, we had another great quarter, delivering a strong competitive performance and maintaining our leadership in the IL-5 class. This remains a market with significant growth opportunities, with unfortunately only 27% of eligible patients in the U.S. receiving a biologic. We're leading share of both new and total IL-5 patients in the U.S., and remain the leader in other key markets around the world, as you can see on this chart.

NUCALA's leading position is built on its proven efficacy, derived from its precision targeting of IL-5 to reduce eosinophils to normal levels, differentiating it from other biologics. We're using that benefit to rapidly expand into other eosinophil-related conditions. In the U.S., we now have approval in EGPA and HES, and have recently submitted our application for nasal polyps. We've also had a first for GSK when we submitted three indications in parallel to the EMA earlier this month, and our studies in COPD are ongoing. We continue to see a great growth outlook for NUCALA. Staying with respiratory and moving to TRELEGY, we continue to not only lead the way in once-daily single inhaler triple therapy for COPD, but grow the market as well. We are growing our share in the U.S., where we are the market leader, as well as in other major markets around the world.

This is an increasingly competitive area, but we've maintained a leading share of voice in the U.S., Europe, and Japan, and continue to see strong growth. The opportunity in COPD is significant, with less than 25% of patients in the U.S. who need a triple being on it today, so there remains substantial scope for growth. Additionally, we received U.S. approval for asthma. About 30% of adult patients in the U.S. with asthma on an ICS/LABA remain uncontrolled, so they could benefit from triple therapy. It is early days, but in the first three weeks to market, we've seen a doubling of NBRx with allergist prescribers, showing that there is an unmet need that is recognized. Next slide, please. Switching to BENLYSTA. It continues to be a great product for us and for lupus patients around the world.

In Q3, we again saw double-digit growth after more than nine years on the market, supported by the uptake of the subcut formulation and the success of our IV launch in China. Lupus is a market with considerable upside potential, and we're driving through targeted lifecycle management, building data, and working on new indications. This quarter, we're very pleased to say we've published positive data from the BLISS-LN trial into New England and received priority review for our submission to the FDA. We expect to have approval by the end of the year and are on track to become the first and only drug indicated for both SLE and lupus nephritis. We will also have data from our combo study with Rituxan in-house by the end of the year, and we're hopeful that this combination, if successful, could potentially lead to clinical remission.

With our ongoing investment in generating important data, we are well-positioned versus potential competition, with established efficacy in a broad base of lupus patients, long-term real-world outcomes data, and a recognized long-term safety profile. What is interesting is more than 80% of eligible patients remain untreated with BENLYSTA in the U.S., and of course, even more around the world. The number treated will increase further with the lupus nephritis indication. There's plenty of opportunity for growth remaining to help these patients. Now to oncology. Although the ovarian cancer market has been impacted by the pandemic, with fewer patients undergoing first-line treatment in the first half of the year, we have been able to execute commercially with ZEJULA and drive our share of the market.

Our best-in-class label, the only PARP inhibitor for all comers in the first-line maintenance setting, has been key to driving market penetration, not only in the BRCA-mutant population, but across all patient types. That is now supported by both the NCCN and ASCO guidelines for patients who've responded to chemo. As of August, almost half of all patients starting on a PARP inhibitor are now getting ZEJULA, and by now, 1/3 with annual repeat patients are on ZEJULA in the front line. In Q3, we saw a 50% increase in the average weekly new writers in the U.S. We've doubled our overall market share from 14% in April to over 30% in August.

We also know there's significant opportunity to continue to penetrate the market, with watch and wait still unfortunately being used in more than 70% of women in the first-line maintenance setting in the U.S. Finally, we're focused on accelerating opportunities beyond ovarian, working in improved outcomes for a broader set of patients. In Q3, we initiated the ZEAL study in combination with pembro to investigate the impact of ZEJULA on both squamous and non-squamous non-small cell lung cancer patients in a maintenance setting. With its differentiated properties of superior tumor penetration and the ability to cross the blood-brain barrier, we believe ZEJULA has the opportunity to improve outcomes and be the best in class PARP in lung. Next slide, please.

We launched BLENREP for heavily pretreated multiple myeloma patients at the end of August in the U.S., though it's early days, we are seeing a positive response across the board from physicians, patients, and advocacy groups. There's a high unmet need in multiple myeloma, over 500 HCPs and over 200 patients have already enrolled in our fully operationalized REMS program. We have a highly experienced sales force, our in-person access to HCP is highest amongst our competitor set.

We're also focused on the continued development of this important medicine and have a robust program in place to improve the safety profile by studying alternative doses and scheduling. Importantly, we also have studies investigating BLENREP in novel combinations with other drugs like pembro, which can have potential synergistic effects, and a combination with SpringWorks' gamma secretase inhibitor, which appropriately inhibits the cleaving of BCMA, potentially enabling a clearer target, driving superior efficacy and an improved side effect profile. We anticipate sharing data on some of these combinations in 2021. Shifting to vaccines, on the next slide, we saw continued impact from the pandemic in the quarter with lower adult wellness visits and vaccination rates in the U.S., although momentum improved substantially in September.

For SHINGRIX, we saw a steady increase in US prescription volumes through the quarter, and by quarter end, they'd reached a similar level to that last seen before the pandemic and comparable to the same time last year. We've been very successful in driving this recovery through our DTC campaign in conjunction with the flu season, and wholesaler inventory levels are now considered normal with about 1.2 million doses in the channel. Outside of the U.S., we saw strong demand from Germany and great progress in our phase launch in China, which is going well. Next slide, please. Before David takes you through the 2DR momentum in HIV, I just wanted to highlight the upcoming readout that we're anticipating for our COVID antibody that we're developing in collaboration with Vir.

Although there are many vaccines in development for COVID, including our own collaboration on adjuvant approaches with Sanofi and others, we believe a therapeutic option will still be necessary. There's a lot of uncertainty about how the pandemic might develop, but it seems likely that we'll continue to see a high level of infections in 2021 and beyond. Even if a vaccine is successful, it will take time to distribute and is unlikely to be 100% effective for everyone. On that basis, I think it's fair to say that there will be a clear need for therapeutics. The Vir antibody has been developed from an antibody taken from a patient infected with SARS-CoV-1. The S309 antibody was found to have extremely high affinity for the SARS-CoV-2 spike protein, and it's highly potent in neutralizing SARS-CoV-2 in live virus cellular assays.

It has three features which lead us to believe that we have a potentially best-in-class asset. The first is that it has a unique receptor binding site, which is highly conserved, and it's required for viral entry into the host. In silico tests of over 80,000 sequences show that this epitope is highly conserved across circulating viral strains, and therefore we expect a high barrier to resistance. Furthermore, escape mutants identified for similar antibodies against other viruses have attenuated or no infectivity. Secondly, the antibody has high potent effector function in vitro, allowing the recruitment of immune cells to kill off infected cells. This potency potentially allows us to have a lower single dose, which will be important as we scale up manufacturing given the large number of potential patients and the fact that global demand for therapeutics is likely to outweigh supply for some time.

Finally, the antibody has been engineered to extend half-life and will potentially enhance availability in the lung. Pivotal COMET-ICE study in the early treatment of patients at high risk of hospitalization is ongoing, and we anticipate having initial data available by the end of the year. On top of this, we're planning to expand studies to include hospitalized patients and for use in prophylaxis. This collaboration has significant potential and is very exciting to us. Let me now hand over to David to take you through HIV.

David Redfern
Chief Strategy Officer, GSK

Thank you, Luke. Hello, everyone. As in the rest of our business, HIV is also benefiting from strong competitive execution. We have the leading share of voice in both the U.S. and Europe, and the benefit is clear in the momentum we are delivering in the two-drug regimens and across our HIV business. We are now seeing US dolutegravir NBRx share outstrip our TRx share, a key point of inflection which demonstrates the traction that we have achieved with the two-drug regimens, which now have over a 9% share of NBRx in the U.S. Dovato in particular is performing very strongly. We saw the inclusion of the TANGO switch data on the US label in August. This has helped Dovato accelerate its share of the US switch market.

We now see about a third of Dovato scripts come from new patients, a third from competitor regimens, and therefore only a third from other dolutegravir regimens. As such, overall, we are seeing a positive net switch to dolutegravir regimens, helping to increase our overall market share in the U.S. In Europe, we are growing ahead of budget, and dolutegravir is gaining market share as we continue to roll out Dovato. We've been able to launch early in all markets across Europe despite the pandemic, and Dovato now has leading share of voice in all measures in all countries. We have also seen a positive start for RUKOBIA, which has U.S. insurance coverage at over 70%, with 250 patients already on therapy. We are making good progress in our discussions with the FDA on CAB in the PrEP setting.

We are on track to file for US approval for PrEP in the first half of next year and anticipate a 2022 approval. We still expect HIV revenue growth overall to be broadly flat in 2020, but anticipate a return to growth in 2021, building on the momentum we have established with JULUCA and DOVATO and with the expected US launch of CABENUVA in the first quarter of 2021. I will now hand over to Brian to talk about Consumer.

Brian McNamara
CEO of GSK Consumer Healthcare, GSK

Thanks, David. I'd like to provide a quick update on our progress with integration, which is progressing well and is firmly on track. Our positive momentum has continued despite the challenges related to the pandemic. Importantly, we've delivered significant milestones to date. 96% of the Pfizer Consumer Healthcare revenue are now in our systems, with 71 markets having made this transition since the start of the pandemic. 87% of co-locations are complete, and 39 of the 41 warehouses identified for closure are now closed. All future market cutovers, employee transfers, and production site integrations remain on track. At the time of the transaction, we provided synergy and financial guidance for 2022, and this remains unchanged. We continue to expect annual synergies of GBP 500 million by 2022, with up to 25% reinvested back into the business to drive growth.

We have also delivered on our divestment commitment, with transactions meeting our target of GBP 1 billion in proceeds already signed. Through this process, we have divested more than 50 growth dilutive brands, strengthening our existing portfolio. Our separation program is also on track, with work around the future organizational structure and system separation well underway. It's important to remember that the end goal of all this integration work is to bring together a fantastic portfolio of category-leading brands with a strong geographic footprint positioned in a sector which is now more relevant than ever. I continue to be excited about the potential of what we have created. A 100% focused global leader in consumer healthcare, addressing consumer needs and driving better everyday health. I look forward to sharing more with you on this great business over the coming years and in the run-up to separation.

Coming back to performance, I'd like to share some detail on the growth drivers behind today's result. I will focus on year-to-date results to take out the volatility behind the pantry loading and the systems cutover. Pro forma revenue, excluding brands divested and under review, grew 6% year-to-date, supported by healthy brand growth and overall share growth. Vitamins, minerals, and supplements continue to benefit from increased consumer focus on health and wellness, and as a result, we saw a strong performance by Centrum, Emergen-C, and Caltrate. On a pro forma basis, category sales grew in the high teens across all three quarters this year, and with growth at 1.5 times the market. E-commerce was strong across all categories, growing at about 80% year-to-date, and now representing over 6% of sales, up a few percentage points over last year.

Key markets such as U.S., China, U.K., and Germany are ahead of this level. Importantly, we've grew significantly ahead of the market and are gaining share. Turning to our priority brands. Across our nine power brands, we saw five of them deliver high single digit or double-digit sales growth, with eight of the nine gaining or holding share. On innovation, we have had a number of exciting launches so far this year. Let me share some details on just a couple to give you some color on what we're doing. We launched the Voltaren Rx-to-OTC switch in May, our fourth Rx-to-OTC switch over the last six years, and the first in the pain category in the U.S. in over 20 years. Voltaren is the number one topical pain reliever globally, despite having not been in the U.S., largest pain market in the world.

The brand is off to a great start, growing the overall US topical category, delivering 100% of category growth, and since launch, is the number one HCP-recommended topical pain brand. In the quarter, we also launched Advil Dual Action, which is the first-ever combination of ibuprofen and acetaminophen. Early results are encouraging. With that, I'll hand it back over to Emma.

Emma Walmsley
CEO, GSK

In summary, we've delivered a resilient performance this quarter with strong commercial execution of our growth drivers underpinned by disciplined control of costs. This, together with an improvement in vaccine immunization rates, we remain on track to deliver adjusted EPS for the year within our guided range. We're also pleased to have maintained progress in delivery against our long-term priorities of innovation, performance, and trust. In R&D, we've had four new approvals in the quarter and generated data to support development of major pipeline assets, including our portfolio of RSV vaccines. Very importantly, we've also been able to advance five possible COVID-19 solutions into clinical development, two very promising antibody therapies, and three collaborations for adjuvanted vaccines. Beyond R&D, integration and consumer health continues at pace, and we have achieved some important milestones in our program to prepare the group for separation into two new companies.

A biopharma company focused on the science of the immune system and genetics, and a new world-leading consumer health company to Hal and Roger and with the rest of the team. With that, operator, we're ready to take your questions.

Operator

Thank you, Emma. Your first question comes from Keyur Parekh. You're live in the call, Keyur. Please go ahead.

Speaker 15

Thank you for taking my question. Dame Emma, first of all, congratulations on your recognition of your achievement. Very much congratulations on that. Just linked with that, who among the senior management team has the best curtsey technique so far?

Emma Walmsley
CEO, GSK

A lot of hands going up on that. It's a recognition for the company. I can assure you, Keyur, nobody in my house takes their towels off and onto the floor anymore. Anyway, going to your technical question.

Speaker 15

Well, you still haven't answered the question, but so the two questions are, one, Hal, there is some amount of confusion on the update that your partners at Merck and you put out about bintrafusp alfa. I was just wondering if you could share your perspectives on what kind of view made out of the update. Clearly, the trial continues, but the proposed expansion of the enrollment kind of isn't happening. I was just wondering if you could share some perspectives on that.

Secondly, as it relates to the reiteration of the guidance for the full year, how much of that relies on SHINGRIX coming back into the fourth quarter, and what level of SHINGRIX revenues might be required to get there? Do you feel comfortable enough to get to the bottom end of the range, irrespective of what SHINGRIX does during the fourth quarter? Thank you.

Emma Walmsley
CEO, GSK

Thanks, Keyur. Let's come to Hal first and then over to Iain for a bit more specifics on the guidance and SHINGRIX contribution.

Hal Barron
Chief Scientific Officer and President of R&D, GSK

Oh, okay. Well, thank you very much for the question, Keyur. Maybe backing up, I think it's important to note that when we initiated the collaboration with Merck KGaA, we did it on a very large and robust phase I data set of over 400 patients, really demonstrating activity, and a very well-tolerated safety profile. Some encouraging response data in lung. As we've said many times, we think it's important to do randomized controlled trials to see whether these observed effects are real when compared to appropriate controls. That is really what initiated the so-called 037 study, to obtain this randomized data. As you say, we updated you last week that the study is not expanding, and we'll be continuing with the 300 patient sample size.

While I know I can't really answer any of your questions more specifically, I will say that we need to await the final data to ensure the integrity of the trial. It's important to wait to discuss any results of the study until we have the full data set, including data on PFS and OS. I realize that leaves you with some questions, but that's really the extent to which I can comment at this point.

Emma Walmsley
CEO, GSK

Thanks, Hal. Iain?

Iain Mackay
CFO, GSK

Yeah. Keyur, just to be absolutely clear, it's my opinion that I do the best curtsey by a long, long way in this group. Being the only guy that wears a skirt in this place anyway. Anyway, moving on from that to the more important point in SHINGRIX. Look, really encouraged by the progress that we've seen through September, and happily that's continued into October. That recovery in older adult immunization rates has been extremely important in terms of how we form the guidance for the full year. We don't necessarily need to grow immensely beyond where we are, but we do need to sustain the recovery that we've seen. Now, September was a great month. I think it was probably the best single month that we'd had in SHINGRIX. Overall growth year-to-date, 6%, obviously below the number that we had guided to for SHINGRIX.

Provided that we can sustain the recovery that we've seen through September, we're also very encouraged by the weekly prescription data and immunization data that we see so far through the month of October, then that certainly should take us to the lower end of our guidance range.

Emma Walmsley
CEO, GSK

Thanks. Just to complement that, I think, fundamentally, we're absolutely convinced that SHINGRIX will be a great growth driver for the company for years to come. If ever we want to be reminded of the opportunities and growth prospects in the vaccines segment, this is definitely the year to reinforce that. Over to the next question, please.

Operator

Thank you. Your next question comes from Graham Parry from Bank of America. You're live in the call, Graham. Please go ahead.

Graham Parry
Analyst, Bank of America

Great. Thanks for taking my question. Firstly, would it be possible to quantify the BLENREP inventory and pension restructuring benefits on adjusted operating income and margins in the quarter? Would you still have been coming in around the sort of consensus level without those in there? Secondly, your guide now assumes R&D mid to high single-digit increase. I think at the start of the year, you were flagging similar growth to 2019 for both 2020 and 2021. That would've been about a 13% increase in R&D, and it's obviously benefited from some of this BLENREP inventory -write- back. Could you just help us understand, should we be expecting a sharp upward inflection in R&D in 2021 as the one-off benefits go away and you continue to invest in the pipeline? Thank you.

Emma Walmsley
CEO, GSK

Thanks. I think both of those to Iain. Just to reiterate, our number one priority is still to keep strengthening the pipeline. We do expect to see a strong increase, but perhaps, next year. Perhaps, Iain, you could put some shape around that.

Iain Mackay
CFO, GSK

Yep, absolutely. Graham, thanks for your question. BLENREP, the capitalization of a pre-approval inventory was just north of GBP 60 million in that factor. When you turn more broadly to R&D expense, the main point to, I think, reiterate in here, and Hal can go into more detail, is that we've kept all our programs very much on track. To the extent that we'd experienced any slight delays earlier in the year on the back of the pandemic, those have been largely recovered. We've still got a little bit to do on gemcitabine but those are very much back on track again.

What Hal and the team have continued to do is realize fully the efficiencies and synergies we expected from the TESARO acquisition and continue to deliver benefits and savings through the R&D, just in terms of how we prioritize and manage spend within that. Reflecting on next year, our guidance would remain absolutely consistent. We'd expect to see double-digit growth in R&D expenditure next year as we continue to invest in those priority programs across the R&D pipeline and made progress in that regard.

Emma Walmsley
CEO, GSK

Hal, I wonder whether you would like to add anything in terms of the sort of overall governance and sort of progress of the pipeline. The other thing to note, Graham, would be that we're, and you'll have seen it, we're slightly down in both vaccines and Consumer Healthcare R&D through integration and cost control. Hal, perhaps you could add some more color around the governance aspect of spend.

Hal Barron
Chief Scientific Officer and President of R&D, GSK

Well, thanks, Graham. We're making a lot of great progress, I think as Emma highlighted in her last comments from the last slide, in particular highlighting that BLENREP started three pivotal studies, making very nice progress on ICOS adding a second phase II sort of head and neck study. The two COVID trials that we're doing in the pharma side have been highlighted, they're going well. Three vaccine trials, including moving the RSV to phase III. We've added 10 new molecules, vaccine to pharma assets into the pipeline. Importantly, we're also using a very high bar to advance things. We're using a high bar for interpreting data. Based on that, we actually removed eight assets as well.

We're tightening up our focus on research in areas that we think are most promising, making a lot of great progress on the human genetics functional genomics side of the research, really have reduced a little bit of spend in the research area. Overall, very encouraged by the progress we're making on the pipeline, we'll be continuing to move aggressively to even strengthen it further.

Emma Walmsley
CEO, GSK

Thanks, Hal. Next question, please.

Operator

Thank you. Your next question comes from Tim Anderson from Wolfe Research. You're live in the call, Tim. Please go ahead.

Tim Anderson
Analyst, Wolfe Research

Thank you. I want to go back to bintrafusp alfa if I can, for Hal. Hal, would you agree that there's two very different but equal interpretations to the recent update? One is that you saw enough of a signal on the interim that you didn't feel the need to upsize the trial to hit survival. The other would be the opposite, which is that it's not worth upsizing the trial because that interim only showed a weak signal. Just to clarify, will there be a milestone paid to your partner? Then second question is another pipeline question, and it's on the ICOS agonist data coming up in first half 2021. You have a second-line lung trial randomized ICOS plus docetaxel versus docetaxel alone. Just your updated thinking on the odds of success with that trial.

Emma Walmsley
CEO, GSK

Okay. Just to confirm that there's been no milestone paid to date on the basis of the data to date. That doesn't mean there couldn't be one in the future. Hal, do you want to make any further comments on bintrafusp alfa and also on ICOS, please?

Hal Barron
Chief Scientific Officer and President of R&D, GSK

Tim, thanks for your question. Our goal is to really be the partner of choice and be an outstanding partner when we work with another company. We've committed to Merck KGaA to have them be the lead on discussing how to interpret all this. I sense the frustration, and I would typically comment more, to be honest with you, but I think it's best said that we should await the data from the trial before making any comments. Sorry for not being more transparent about that. In terms of your question about the INDUCE-Lung study, the ICOS study, from memory, that's about 105-patient study, the design as you described, and it is a phase II where we'll be looking at all the classic sort of endpoints you might expect.

I think it'll be important, because that'll be the first randomized data that really gives us a sense of the incremental activity that ICOS could engender there. I am cautiously optimistic that that might show activity, and if it did, it would certainly be a huge boost to the program and drive subsequent study designs and probably thinking about where the molecule fits in medicine.

Emma Walmsley
CEO, GSK

Thanks, Hal. Next question, please.

Operator

Thank you. Your next question comes from the line of James Gordon from J.P. Morgan. You're live in the call, James. Please go ahead.

James Gordon
Analyst, J.P. Morgan

Hello. James Gordon, J.P. Morgan. Thanks for taking the questions. Two questions, please. Really coming back to the same point. One more on TGF-β, which would be, I noted the comment on not giving specifics about what you saw at the interim and that there hasn't been a milestone paid. Can you just say more generally, how is GSK thinking about investing in this mechanism in other frontline cancer trials? Could this be an area where we're going to see much more investment over the next few years and you're going to go broader? Do you still see this as just as much as a bet when you first started or first entered into this partnership? Any increased confidence to go broader would be the first question. The second question, pipeline news flow and specifically dostarlimab.

Based on the slides, dostarlimab and in that program, at the end of non-COVID-19 NCEs, we're going to have phase III data in 2021. I know you recently renegotiated the deal on dostarlimab, so it allows you to partner with other PD-1 agents other than Dosta. Just how much potential does Dosta have? Is this something that is a big focus? Should we think this will be one of the key readouts for 2021? Is there other aspects that you're much more excited about than Dosta now?

Emma Walmsley
CEO, GSK

Hal, both to you.

Hal Barron
Chief Scientific Officer and President of R&D, GSK

Okay. Let me go with the dose first. We're excited about having dostarlimab. It obviously is a part of the PD-L1 class, which of course has transformed oncology and probably as a class will be the greatest, biggest medicine maybe ever. We're excited to have one. We think that its two six-week dosing, it's actually dosed at a higher level than other PD-1s, could be an attractive attribute. I think the greatest opportunity for us with dostarlimab is to be able to combine it, particularly with our pipeline reagents. We have the DREAMM-4 study with belantamab mafodotin, with PD-1 inhibitor. We have, of course, the opportunity to combine PD-1 inhibition with olaparib, whether that be in lung or in ovarian with the first trial. We certainly have opportunities to combine dostarlimab with pipeline reagents that are earlier on, like CD96 and STING and ICOS, and other agents.

It is a nice complement to our pipeline, and we're very excited about its activity. Of course, it's also active in endometrial cancer, both in second line, and we've got the front-line study going. We are hoping that we can have a tumor-agnostic approval at some point with the data beyond endometrial, with colon, et cetera. We think it has a lot of potential, and that's in part why we renegotiated, as you described, to give us a lot of flexibility on the olaparib as well. Sorry, the other question was, I didn't write it down.

Emma Walmsley
CEO, GSK

bintrafusp in broader studies.

Hal Barron
Chief Scientific Officer and President of R&D, GSK

Yeah. For bintrafusp, we were very excited about the preclinical rationale for inhibiting TGF-β. The bifunctional nature of the protein to hit PD-L1 and target the protein to the tumor is attractive. The phase I data, as I commented on, was very large and robust and seemed to have signals of activity and a well-tolerated profile. We get more data, we'll make data-driven decisions about where to invest. I can't really say more than that, as soon as we get incremental data, we will be sharing that and sharing where that leads us to invest in subsequently.

Emma Walmsley
CEO, GSK

Thank you. Next question, please.

Operator

Thank you. Your next question comes from the line of Steve Scala from Cowen. You're live in the call, Steve. Please go ahead.

Steve Scala
Analyst, Cowen

Thank you. First, do you think the inflection in the two-drug regimens that you speak to is already reflected in DOVATO numbers, or is that yet to come? That's the first question. Second question is, I would like to ask about the recent thinking on the dividend. I know it's a board decision, but 25% of the board is on this call and another 25% are former CFOs at drug companies. I would think that half the board can't find appealing paying out the majority of free cash flow to cover the dividend. Emma, would you disagree that a good portion of the board likely thinks that a change in dividend policy would be in the best interest of building the company? Thank you.

Emma Walmsley
CEO, GSK

Thank you. We'll come to David in a moment on 2DRs and the growth prospects for our HIV business, also including the upcoming pipeline. On the dividends, Steve, I'm afraid I'm going to reconfirm there is absolutely no change to the board's position on capital allocation or our dividend policy. Obviously, we're working towards separation of the group. We've been clear on what the dividend is going to be for the consumer healthcare business in contract with Pfizer, and as we get closer to the separation and the confirming on that, we'll update with the full board's views in terms of distribution for that, but no further comment on that at this stage. David, over to you for an answer.

David Redfern
Chief Strategy Officer, GSK

Thanks, Steve. It is true. We're pleased with the performance of two-drug regimens across the world, and particularly DOVATO. Very strong in Europe, where it's now rolled out everywhere and we're seeing rapid pickup. As I said in my remarks, in the U.S., we've seen a very clear inflection in the NBRx, and particularly in switch, since we got the TANGO data included in the label in the summer. NBRx is running at about just over 9%.

TRX is running around 5%. Some of it's in the numbers, but I think still quite a lot more to come in the U.S. in particular. I think it is just symptomatic of all the data, whether it's the clinical data, the real-world data, the experience that physicians now have. We are seeing very good momentum, and I think that will come through more and more strongly in TRX in the numbers.

Emma Walmsley
CEO, GSK

Thanks, David. Next question, please.

Operator

Thank you. Your next question comes from Andrew Baum from Citi. You're live in the call, Andrew. Please go ahead.

Andrew Baum
Analyst, Citi

Thank you. I've only got one question, but it's a slightly longer one. Emma, you just recently restated that building the pipeline for the pharma business is your number one priority.

Emma Walmsley
CEO, GSK

Yeah.

Andrew Baum
Analyst, Citi

GSK doesn't have the strongest balance sheet compared to its peers, and the dividend policy doesn't help. You still have firepower to do meaningful bolt-on acquisitions for late-stage assets. When I look at the last 18 months. Merck has taken out ArQule, AbbVie signed with Genmab, Astra, Daiichi, before that, Lilly Loxo. I'm surprised that we haven't seen any activity from GSK, particularly in hematology, given the investment that you're making in the space and the obvious synergies that could be with a late-stage product within that area. The question is, what am I missing?

There still are late-stage hematology assets for BD, some of which could be accretive immediately. Is this the valuation doesn't make sense for you? Is it you're looking for internal gating in order to determine strategy? Is it concerns about the future of U.S. reimbursement? What am I missing here?

Emma Walmsley
CEO, GSK

Well, it's an important topic, and I'm not sure that you're missing anything because we are absolutely clear in recognizing your observations that our number one priority continues to be strengthening the pipeline, and it's our number one priority for capital allocation, including business development. We keep, whether it's for internal assets or external ones, as Hal alluded to, we keep the bar high. We want to make sure they're obviously in line and fueling the strategy that we've laid out for biopharma and have the right kind of discipline around returns.

We certainly see it as a priority for new GSK, and that's exactly why last quarter, we built out the deal with Vir, which clearly we see as having significant potential and was announced this year, but if it's successful with data later this year, could be in market next year for something with really significant sales global demand. We also continue to look at technology platforms as evidenced by the deal we struck with CureVac around multiple options in terms of vaccines development. Continue to watch this space, and we continue to be prioritizing this as an area for team focus and energy. I think we now have time to move to one last question.

Operator

Your last question comes from Kerry Holford from Berenberg. You're live in the call, Kerry. Please go ahead.

Kerry Holford
Analyst, Berenberg

Thank you. Two questions, please. Firstly, on the COVID antibody, Luke, you spoke about the potential for an extended half-life. I wonder if you can provide us with any more detail here. Are we talking weeks, months? Do you think one shot could cover a whole winter season, for example? I know we haven't seen full data, but any feeling around your comments there would be helpful. On ZEJULA, you talked about the progress being made in the first-line ovarian market, but did that indication contribute much to sales in the quarter? This still seems relatively slow. I guess, when do you think we should expect any more things to ramp in sales in that setting? Thank you.

Emma Walmsley
CEO, GSK

Thanks, Kerry. We'll come to Luke on ZEJULA, but then I'd like to come back to Hal, please, to finish up with the comments on the prospects and possibilities for the Vir antibody. Luke, first to you on ZEJULA.

Luke Miels
CCO, GSK

Sure. Thanks, Emma, and thanks, Kerry. One thing I'd put in context, it's really interesting when you look at the debulking surgeries in the U.S. It's not interesting, I think it's sad. They dropped by about 35% in April and May, and they steadily recovered through June and July, but they're still around 10% below the levels of February. That's obviously having an effect on patient flow. If we look, and it's really in the U.S. because when we look in the quarter, we didn't have the label of first-line in Europe, but if you look at our spread of patients in the U.S. for ZEJULA, about a third of them are in first line now, are split between treatment and maintenance, about a third of patients on treatment and about two-thirds on maintenance. Yeah, around a third of sales are now coming from first line.

If you look at our share growth, and your point is accurate, our growth has come from taking it away from olaparib within the class. Hopefully, as we now move through, and start to, at some point, see some stabilization in the COVID environment, we can begin to see the overall class grow in first line and the number of people on watch and wait be reduced.

Emma Walmsley
CEO, GSK

That 70% on watch and wait is really the opportunity here as well as we hope in due course expanding ZEJULA beyond ovarian. Hal, back to the Vir antibody.

Hal Barron
Chief Scientific Officer and President of R&D, GSK

Yeah. Thanks, Kerry. The Vir antibody is actually very special, very unique for a number of reasons. As Luke mentioned in the presentation, I think it's important to highlight that this was found through exploration of antibodies from patients with SARS-CoV-1. The argument and the rationale for choosing such an approach was that if over this period of time, the SARS virus that resulted in COVID-19 has a neutralizing antibody to both, that the epitope the antibody is binding to is likely very important for its infectivity, and therefore significantly reduced chance of mutating around that. The CDR regions, we think, are incredibly important and why we think there's going to be very limited resistance to a single monoclonal.

That's particularly important given some of the Lilly data, where I think it was somewhere between 6% and 8% of the patients had resistant clones in the many clones that are emerging through the genetic drift and even the D614G mutation that's becoming more prevalent, probably due to a fitness advantage. In addition to that, it being highly neutralizing, it actually has a modified Fc receptor that not only gives it an extended half-life, to your point, which we think we're not exactly sure how long that'll be, but it will be most likely substantially longer, somewhere probably between two, three, maybe even four months of duration. Considerably more than what you'd expect from a typical antibody because of this modification, which has been done on other antibodies that have been in the clinic, so we're reasonably confident it will extend half-life.

In addition, there's a modification of the effector function so that in addition to being neutralizing the antibody through this increased effector function, should be able to bind and destroy cells that are infected with the virus. That's very unique. That's not something you would see with the other antibodies, we don't think. This could give us a greater efficacy, maybe allowing us to even use lower doses, et cetera. We think the Fc modification not only extends half-life, but the effector function may be very important. Combined with that, the lower dose that's being explored compared to other monoclonal antibodies, the single monoclonal nature, and the ability most likely to effectively neutralize the resistant strains, is unique.

Lastly, I'll just mention that we do see lung accumulation of the antibody, whether that's due to some of these modifications in the Fc or other attributes isn't clear, but the antibody also does seem to preferentially go biodistribution-wise into the lung, which we think will give it yet another advantage. We're very excited about this program and think it could really offer a significant solution for COVID, and hopefully we'll have data soon to support that.

Emma Walmsley
CEO, GSK

A concluding reason for optimism to which I'd add to the resilient performance that we've delivered, and the fact that we're on track to be within our guidance range, despite particularly challenging circumstances. We're encouraged by commercial execution across multiple growth drivers, and optimistic for both the near-term recovery and long-term prospects for vaccines. We're seeing strong progress on our strategic imperatives, whether that be in pipeline, particularly including COVID solutions or indeed in terms of the separation preparation, which is very much firmly on track and we think gives exciting options for returns to shareholders in the coming years. With that, thank you all very much for joining us, and we look forward to speaking and seeing you soon.

Operator

Thank you, Emma, thank you to all your speakers. Thank you everyone. That concludes your conference call for today. You may now disconnect. Thank you for joining, and enjoy the rest of your day.