GlaxoSmithKline PLC

LSE:GSK

Earnings Call Transcript 2021-Q3

[Operator]

Good afternoon, everyone, and welcome to the analyst call on the GSK Third Quarter 2021 Results. I will now hand you over to Nick Stone, Head of Investor Relations, who will introduce today's session.

[Nick Stone]

Thank you, operator. Good morning and good afternoon. As you've just heard, I am Nick Stone, Head of Investor Relations at GSK. It's my pleasure to welcome you to our third quarter 2020 conference call and webcast for investors and analysts. The presentation was posted to gsk.com and was also sent to our distribution list a little bit earlier today. Please turn to Slide 2. This is the usual safe harbor statement, and we'll be making comments on performance using constant exchange rates, or CER. Please turn to Slide 3. This is today's agenda where we'll plan to cover all aspects of our results. The presentation will last approximately 25 minutes in order to maximize the opportunity for questions. [Operator Instructions] Our speakers today are Emma Walmsley, Luke Miels, Deborah Waterhouse, Brian McNamara and Iain MacKay. The Q&A portion of the call, we will be joined by Dr. Hal Barron, Roger Connor and David Redfern. And with that, I will now hand the call over to Emma. Please turn to Slide 4.

[Emma N. Walmsley, CEO & Director]

Thanks, Nick, and a warm welcome to everyone. On to Slide 5. I am delighted to announce another quarter of strong financial performance and continued progress against our strategic priorities. Third quarter sales and adjusted EPS were both up 10% at CER. These excellent results were driven by strong commercial execution and underlying demand with double-digit growth in Pharma and Vaccines, 24% growth in New and Specialty Medicines, proof that our pipeline is bearing fruit, and an acceleration in Consumer Healthcare growth. Continued cost discipline supported this performance. Today's results demonstrate the building momentum in the business, which has enabled us to improve our full year 2021 adjusted EPS guidance and narrowed the range to between minus 2% and minus 4% at CER. The guidance excludes any contribution from COVID-19 solutions, which we now expect to contribute an additional 7% to 9% to this adjusted EPS for the year, a very positive result. Alongside our strong financial performance, we continue to make excellent progress in R&D. Additional indications have been approved for Nucala in respiratory and Jemperli in cancer. We also received U.S. FDA priority review of cabotegravir for the prevention of HIV. Following the positive headline results announced in July for daprodustat, another potential best-in-class new medicine for treating chronic kidney disease, we will present key data in a late-breaking session at ASN Kidney Week. The demerger and creation of the world leader in consumer healthcare continues to be fully on track, and we were delighted to unveil exciting plans for a new global campus and innovation center here in the U.K. And lastly, as we look ahead together, we are all strongly committed to delivering health impact at scale and maximizing value for shareholders. Our resolute focus remains on world-class execution and successful delivery of our stated key strategic objectives, beginning with a step change in growth in 2022, an exciting and important year for our company. Turning to Slide 6. Progress in the third quarter was reflected across all 3 of our strategic priorities. In innovation, we continue to build a high-value pipeline across prevention and treatment of disease through organic and inorganic delivery. I just mentioned some of the highlights and several more are listed on the slide. Among them, I'm also delighted we are now playing a meaningful role in the COVID-19 response through our antibody treatment, Xevudy. We have several COVID-19 vaccine programs soon to read out, and we remain agile as the environment continues to evolve. In performance, continuously improving commercial execution is driving robust growth and strong share performances in new and specialty products. For Shingrix, specifically, we have seen an impact through the result of the surge in the Delta variant, but we are increasingly confident we're on the recovery track. The initiatives we've put in place and the underlying demand will drive strong growth in 2022 with the potential to deliver record annual sales. Luke is going to take you through the details of this in a minute as well as our confidence in the medium-term opportunity for Shingrix. And for the success of dolutegravir and cabotegravir, with the potential to anchor the next generation consumer, strong brand performance also drove a significant acceleration in growth in the quarter, as Brian will speak to. Lastly, on trust, we continue to maintain leadership in ESG with the recent announcement of significant renewable energy investment and carbon reduction initiatives at our manufacturing sites in the U.K. and U.S. We also announced a new R&D program to reduce greenhouse gas emissions from our metered dose inhalers, which are responsible for 45% of the company's carbon emissions. And these new initiatives support the continued progress on our environmental commitments to be net zero and nature-positive by 2030, which we'll share more on at COP26. I also, of course, welcome the recent WHO recommendation for a broader deployment of our malaria vaccine. Malaria kills more than 250,000 children a year in sub-Saharan Africa, and this is the first and only vaccine shown in pivotal long-term clinical trials to significantly reduce childhood illness and death from malaria. Please turn to Slide 7. I want to take a moment to expand on my comments on innovation. At our investor update in June, we shared how we significantly improved R&D productivity since 2017 with a top quartile performance versus our peers for the number of launches with the approval of 11 major malaria vaccines. We've more than doubled the number of assets in Phase III or pivotal studies from 11 to 23, and created a pipeline of over 60 medicines and vaccines, many with first-in-class or best-in-class potential. The result of all of this work and targeted investment in an increasingly valuable pipeline with real momentum. It is worth restating that major pipeline approvals delivered from 2017 to 2021, plus anticipated pipeline approvals will drive more than 100% of our forecasted sales growth from 2021 to 2026. Over the next 12 months, you're going to see a number of readouts and regulatory -- support the confidence we have in the outlook we provided for the GSK in June. Specifically, we expect to report key readouts on up to 7 of the 11 assets we highlighted, including our older adult RSV vaccine in the first half of 2022 as well as proved concept data on our potential hep B therapeutic. And we're planning a regulatory submission for BLENREP in third-line multiple myeloma. And as I mentioned previously, you're going to hear a lot more on daprodustat at ASN Kidney Week and our Investor Science Event, which is also scheduled for early November. Please turn to Slide 8. So lastly, I want to take a moment on the time lines for demerger of our world-leading Consumer Healthcare business. We're in countdown mode and moving at pace with our plans to unlock the potential of both GSK and Consumer Health, strengthen GSK's balance sheet and maximize value for all our shareholders. We're committed to the demerger of at least 80% of GSK's holding and for the remaining 20% to be monetized in a timely and pragmatic manner. As momentum builds towards this important event, you're going to see several important steps in the process. Most visible will be the announcement of a Chair Designate, and subsequently, an appropriately skilled Board for Consumer Health. In the first quarter of 2022, we plan to hold a Capital Markets Day, which will set up in detail the performance and compelling prospects for Consumer Health as a new and independent company. We then proceed with the premium listing of the new consumer business on the London Stock Exchange creating 2 companies set up for independent delivery of competitive growth, shareholder value and scale impact on human health. Now let me hand over to the team to take you through the growth drivers in detail. So Luke, first, over to you.

[Luke V. Miels, President of Global Pharmaceuticals]

Thanks, Emma. So we made strong progress in the quarter on commercial execution and competitiveness, which you've seen come through in the revenue and market share numbers. For today, I want to focus my remarks on our strong performance in New and Specialty and our confidence in the growth prospects for Shingrix. Please turn to Slide 10. Growth in our New and Specialty pharma medicine accelerated to 24% in the third quarter, taking us to 18% growth year-to-date. These figures include HIV, which Deborah will cover in a few minutes. As we've seen throughout 2021, Trelegy continues to deliver with 77% growth in Q3. The asthma indication is proving to be a unique differentiator, and our leading position in this space remains unchanged with Trelegy holding 90% of the single inhaled triple therapy market in the U.S. Our market-leading IL-5 Nucala also contributed double-digit growth, up 20% in the quarter. We continue to hear from physicians at a clear and targeted approach to EOS-driven disease is preferred, and we remain confident in Nucala's market opportunity as we launched nasal polyps in the U.S. in July and received positive CHMP opinion for EGPA, HES and nasal polyps in Europe. Additionally, Benlysta has its 17th consecutive quarter of double-digit growth, up 35% in Q3. Our convenient subcut formulation and lupus nephritis indication in the U.S. built on the established leadership we have in Italy, while we continue to build the market in other parts of the world like China. And finally, our oncology portfolio continues to grow. We received an additional approval for Jemperli in August and in Q3 grew Zejula sales by 14%. We continue to see 1 in 2 new part patients receiving Zejula despite a tough external environment where, unfortunately, diagnosis rates remain about 16% below pre-COVID levels. Encouragingly, and based on new patient start data, we're also seeing Zejula as the preferred choice for new patients across 3 lines of therapy. For BLENREP, we now have more than 4,000 patients treated globally, and we're expanding use in the community where the majority of multiple myeloma patients are. We look forward to the opportunity of more patients benefiting from BLENREP as 2 pivotal studies, DREAMM-3 and DREAMM-8 readout. Please turn to Slide 11. In Vaccines, we delivered a strong quarter of growth, with Shingrix on the recovery track following pandemic-related disruptions that impacted performance earlier this year. The performance of Shingrix in the quarter primarily reflected a favorable impact from inventory movements and also a larger proportion of Shingrix being administered in HCP offices, a trend we've been tracking through the course of the pandemic as retailers prioritize vaccinations for COVID-19. Performance outside the U.S. is also encouraging with the recovery underway in Germany and several successful launches in new markets. As you can see on this slide, Shingrix TRx volumes are improving as we move through the year despite disruption from the Delta variant slowing the pace of the recovery. With a challenging comparator in Q4 ahead and prioritization of COVID-19 booster vaccinations in the near term, we now expect the year-to-date performance, which is minus 11 CER, to be a good indication for the direction of travel for Shingrix for the full year. While this is below our previous sales expectation, we consider these as deferred not lost sales. Our confidence in this transformational vaccine remains unchanged, and the underlying demand remains strong. Our market research confirms that patients that have been fully vaccinated for COVID ranked their interest in getting a shingles vaccine higher than any other adult vaccine except flu. And we're implementing activities to drive recovery with multichannel direct-to-consumer campaigns, engaging healthcare providers and further strengthening our relationships with U.S. retailers. Looking ahead, we continue to launch in new markets with our unconstrained supply position, and we expect continued U.S. recovery as we work through covered boosters in the near term. Taken together, we anticipate Shingrix to deliver strong double-digit growth in 2022. And assuming an improved operating environment, we expect next year to be a record year for Shingrix turnover. Further, we remain confident in our ambition to double revenues in the next 5 years, protecting more than 100 million adults along the way. Now let me hand over to Deborah. Please turn to Slide 12.

[Deborah Jayne Waterhouse, Chief Executive Officer of ViiV Healthcare]

Thanks, Luke. Third quarter HIV sales grew by 8%, driven by the growth in the innovation portfolio and taking year-to-date growth to 4%. In Q3, around 2% of the growth was driven by favorable wholesaler purchasing patterns in the U.S. and 2% by the growth of tenders in the international region. Strong commercial execution is driving performance of the innovation products, which now represent 29% of our portfolio, delivering almost GBP 1 billion of sales year-to-date. Dovato, in particular, continues to grow strongly, building on the positive momentum that we saw in Q2. In the U.S. and Europe, despite the suppressed switch market, Dovato has gained further share with 15.3% and 27.8% of the switch market, respectively. Turning to Cabenuva, the world's first long-acting injectable treatment for HIV. As with any new class of medicine, Cabenuva will take time to build and the COVID environment continues to constrain switch activity, particularly where a patient needs to visit a physician's office. We have robust lead indicators with over 80% market access and strong brand recognition. More than 2,000 people living with HIV are now taking Cabenuva and intend to prescribe levels are high. We are very excited about the potential approval and launch of 2 monthly dosing in the U.S. in early 2022. This quarter, we also made significant progress with cabotegravir long-acting for prevention. Last month, the FDA confirmed that it has granted Priority Review status, which builds upon its prior identification as a breakthrough therapy. We believe this underscores the importance of this medicine, supported by the results of the HPTN studies which demonstrates cabotegravir's superior efficacy over daily oral FTC TDS tablets.And in the United States, fewer than 25% of those who could benefit from that are currently taking it, which points to the need for additional HIV prevention options. A final FDA regulatory decision is anticipated in January 2022. As we said at the investor update in June, we expect our long-acting portfolio of Cabenuva and cabotegravir long-acting for prevention to generate sales of around GBP 1 billion by 2026. We were also particularly proud to announce a new collaboration with our long-standing partner, Shionogi, on a third-generation HIV integrase inhibitor with potential for ultra long-acting dosing intervals. This agreement aims to build on the success of dolutegravir and cabotegravir, with the potential to anchor the next generation of innovative long-acting therapies beyond 2030. I conclude by inviting all of you to attend an HIV Investor Event on the 29th of November, in which we will share further details about the growth outlook and early-stage pipeline. There will, of course, be plenty of time for you to ask questions. With that, I will hand over to Brian. Please turn to Slide 13.

[Brian McNamara]

Thanks, Deborah. Now turning to Consumer Healthcare in Q3. We saw strong growth with sales excluding brands divested and under review up 10% at constant exchange rates, reflecting good momentum and execution across the business. Importantly, performance improved across all categories and regions, helped by strong investment in the business. Emerging markets performed well with continuing business up double digit, and with China and Middle East and Africa standout performers. Let me provide some color on our category performance. In oral health, sales increased 5%, reflecting continued good execution and successful innovation. Pain relief was up double digit, helped by easy comparators last year and strong double-digit growth in brands, including Advil and Panadol more than offsetting a low single-digit decline in Voltaren. The Voltaren decline was expected given the entry of private label into the category following the successful U.S. Rx to OTC switch last year. Vitamins, Minerals and Supplement growth was up 19%, driven by strong growth in emergency and good Centrum results, helped by increased capacity enabling a return to more normal retail stock levels. Respiratory benefited from good growth in allergy and in cold and flu as well as some help from favorable comparators in the prior year, resulting in sales up 16%. Digestive Health and other sales were up 3% in the quarter. Similar to consumer peers, we saw further pressure from cost inflation in the period. However, our cost structure, combined with a continued focus on productivity, along with pricing across our categories and regions, enabled us to increase both gross margin and our operating margin. Innovation continue to be an important growth driver, and we had 6 first market launches in the quarter, taking this number up to 25 year-to-date and 281 launches, including market rollouts. In e-commerce, year-to-date, we grew in the mid-20% range and is now 7% of sales. Our ongoing investment in digital capabilities continues to position us well for growth in this key channel. Year-to-date, 7 of our 9 power brands maintained or gained share. Our full year sales outlook remains unchanged and demerger plans remain firmly on track. We're making good progress on standing up the functions and building the future processes needed to be a separate company. Finally, I'm looking forward to sharing more information with you on this incredible business as we move closer to separation and at our Capital Markets Day in Q1 next year. Through the 2 largest Consumer Healthcare transactions in the last 6 years, we've created a great business, the global leader in consumer healthcare with a fantastic portfolio of brands and strong capabilities to drive sustainable market outperformance. With that, I will hand it over to Iain. Please turn to Slide 14.

[Iain James Mackay, CFO & Executive Director]

Thanks, Brian. As I cover the financials, references to growth are at constant exchange rates, unless stated otherwise. Please turn to Slide 15. This is a summary of the group's results for Q3 and the year-to-date. In Q3, turnover was GBP 9.1 billion, up 10%; and adjusted operating profit was GBP 2.9 billion, up 16%. Total earnings per share was 23.3p, up 3%; while adjusted earnings per share was 36.6p, up 10%. In the year-to-date, turnover was GBP 24.6 billion, up 3%; and adjusted operating profit was GBP 6.9 billion, up 8%. Total EPS was 72.7p, down 19%; and adjusted EPS was 87.7p, up 5%. On currency, there was a headwind of 5% on sales and 7% in adjusted earnings per share, in particular, due to the strengthening of sterling against the U.S. dollar relative to third quarter of last year. Slide 16 summarizes the reconciliation of our total to adjusted sales. The adjusting items noted for the quarter was intangible impairments, which primarily reflected the results -- sales and the termination of the agreement with Merck KGaA on bintrafusp alfa. My comments from here onwards are on adjusted results, unless stated otherwise. Turning to Slide 17. The key drivers of revenues and profits for the group in Q3 compared to the prior year are set at a year. Revenues grew 10% overall. Excluding revenues from our COVID solutions, sales were up 8%. The positive operating leverage from higher sales in the quarter was bolstered by continued focus on cost control and the benefits of restructuring across the group. This was alongside the expected 15% increase in R&D investment. The resulting Q3 margin was 31.7%, and year-to-date margin of 28.1%. We now expect R&D to grow high single digits in the full year, reflecting upscaled investments, balance -- and continued realization of efficiencies with our approach to one R&D. Moving to the bottom half of the P&L on Slide 18, I'd highlight that the effective tax rate of 20.6% was higher than last year and reflected the timing of settlements with the various tax authorities. We still expect the full year effective tax rate to be around 18%. We also still expect interest expense to be between GBP 800 million and GBP 850 million. I'll briefly cover free cash flow for the quarter before going into more detail on the financials of each business. Turning to Slide 19. In the year-to-date, we generated GBP 1.5 billion of free cash flow. The main positive factors were increased adjusted operating profit at constant exchange rates, lower dividends to noncontrolling interests and lower tax payments mainly in the U.S. versus the comparative period. The primary factors more than offsetting this were increased purchase of intangible assets, including our collaborations with Elekta and Ethos, adverse timing of returns and rebates compared to 2020 and adverse exchange impacts. Improving cash flow performance continues to be a constant focus for the team, and pleasingly, we're ahead of expectations for the year. However, we do still expect this year to be a significant step down versus 2020. Turning to performance of the Pharma business on Slide 20. Overall, Pharmaceutical revenues grew 10%, driven by strong growth in New and Specialty medicines, favorable U.S. return and rebate adjustments and sales of Xevudy in the quarter, which contributed approximately to 3 percentage points of growth. In year-to-date, overall revenues grew 5%, and we're raising our expectations for sales to increase low single digits in the full year, excluding Xevudy sales. Within this, we still expect established Pharma sales to decline high single digits in 2021. The Pharma operating margin was 29.4% in Q3 and 29.2% year-to-date. The increase in Q3 primarily reflects the positive operating leverage from increased sales as well as continued tight cost control and restructuring benefits. These positive margin dynamics were delivered alongside our focus on increasing R&D investment, which grew 11% in the quarter. The prior period comparator included the recognition of prelaunch inventory for BLENREP which was a credit of slightly over GBP 50 million. Please turn to Slide 21. This is an overview of Vaccines performance with overall sales growth of 13%. Excluding pandemic adjuvant revenue, sales growth was 8%, primarily driven by Shingrix in the quarter, which Luke described earlier. In the year-to-date, total Vaccines revenues were up 5% and down 2% excluding pandemic adjuvant sales. With sales year-to-date on the strong Q4 comparator, particularly for Shingrix, we now expect Vaccine sales to decline mid-single digits this year, excluding pandemic adjuvant. This has no impact on our midterm expectations for the Vaccines business where we continue to be very confident in the demand for our products and high single-digit growth outlook. Notably, with regards to Shingrix, where we've set the ambition of doubling sales by 2026. The operating margin was 47.5%. The increase in operating profit and margin primarily reflected the positive operating leverage from sales growth with positive mix as well as higher royalty income. Partly offsetting this was increased R&D investment of 46% as we progressed our RSV and meningitis development programs and invested in our mRNA platform. The year-to-date operating margin was 37.3%. Please turn to Slide 22. Q2 revenues in Consumer Healthcare increased 10%, excluding brands either divested or under review. Including those brands, turnover grew 8%, and Brian outlined the main drivers earlier. In year-to-date revenues, excluding brands either divested or under review increased 3%. The operating margin for Q3 was 25.9%, up 420 basis points of constant exchange rates versus last year. Year-to-date operating margin was 23.6%. Consumer in the full year, excluding brands divested or under review, we continue to expect low to mid-single-digit percentage revenue growth. Turning to Slide 23. Closer considerations for our 2021 outlook. Following our strong performance in the year-to-date, we're now confident that we can improve our full year guidance. As a result of continued commercial execution, sustained delivery of tight cost control and the anticipated dynamics for Q4, we now expect adjusted earnings per share to be between minus 2% and minus 4% constant exchange rates, excluding the impact of COVID solutions. We also now expect COVID solutions to contribute approximately 7 to 9 percentage points of earnings growth in the full year, following better-than-expected progress on Xevudy contracting. It's worth noting that the outcome within that range is still dependent on pandemic adjuvant contracting for 2022 and the resulting potential charges within cost of goods sold as we continue to manufacture for this potential. Key factors that influenced Q4 where we delivered in the full year range will continue to be the trend in adult vaccination rates within the context of the COVID environment, the relative phasing of launch investments to generate future growth and the effective tax rate. We'll keep you informed of our progress in executing against our strategy through events such as the HIV update Deborah referred to and the upcoming Investor Science Event for daprodustat. We hope you'll be able to join us for these events. In summary, we believe the business momentum from the excellent work of our teams sets us up for a step change in growth in 2022, which is both an exciting and important year for the company. We'll provide formal guidance for 2022 with our full year 2021 results in February. Overall, an encouraging quarter and positive momentum. With that, operator, we're ready for Q&A.

[Operator]

Your first question in the queue comes from James Gordon from JPMorgan.

[James Daniel Gordon, Senior Analyst]

James Gordon from JPMorgan. First question was on OpEx. I want to reiterate comments about meaningful operating margin expansion next year, but also SG&A was 5% below and R&D 8% below expectations today. So the question is how much is lower OpEx by cost avoidance versus structural changes at the company? And as we look into next year from the high base, when you talk about meaningful expansion, could new GSK have hundreds of basis points of EBIT margin expansion next year? Or could there be a bit of catch up if things get better with COVID and you have to start spending more? So that's the first question, please. Second question was about consumer separation. A couple of weeks ago, Bloomberg was reporting that the Consumer division could attract bids from PE firms or other pharma or consumer companies. So have you had recent informal expressions of interest in the consumer business? And are discussions ongoing in parallel with the separation process you described? Or is that story inaccurate about something that happened historically and it's definitively just the separation process described?And then just finally, just a clarification. I saw a comment about price rises in the U.S. for consumer. So are you able to tell us what the price rises are that you put through in October in consumer? And how do you see the pricing power of the business going forward, please?

[Emma N. Walmsley, CEO & Director]

Great, James. Well, thanks very much for that. I'll just comment on the separation, first of all. And as I outlined today, we are very committed to the demerger of at least 80% of our holding in consumer. We're absolutely on the runway for that. We've had tremendous amounts of positive feedback from investors who are interested in owning this business and really looking forward to sharing with you in Q1 with the management team, the prospects for that business in much more detail on its competitive advantage and the strength of the brand portfolio. We've consistently said that we will seek to monetize in a timely and pragmatic manner the up to 20% remaining part of our portfolio -- part of our shareholding in that business. And we are just really focused -- of course, the Board will always do its producer with GT, but we are really focused on the significant amount of work that's delivering on this separation and the tremendous value unlock that's going to bring. I'll let Iain comment on the dynamics of OpEx, although I know his first answer is going to be we'll guide in 2022. And then Brian, could come back with some specifics on the price because we do think we're a bit advantaged on that dynamic versus some other consumer companies. But Iain, first to you.

[Iain James Mackay, CFO & Executive Director]

So predictable. James, thanks for your questions. We will absolutely provide detailed outlook for 2022 in early February '22 when we get there. On your OpEx question, so I think one of the things that's really important to note, which is true across the business over the course of this year and last, is just a very strong focus we've gotten tight cost control across really every line within the P&L, whether it's within our cost of goods sold and great product [Technical Difficulty] both within the Pharma -- well, across the Pharma, Vaccines and Consumer Healthcare businesses, really from within the manufacturing sites through the logistics and to our main storage areas, also from an SG&A perspective.And then notably, within R&D, continue to keep moving our trials, moving along at pace. Sometimes in quite an operating -- difficult operating environment, but also realizing benefits through our approach to one R&D that Hal and his team have been leading. There's another factor that has continued to play a part in 2021, and that is lower expense in line items, for example, in travel and related expenses, where, frankly, our level of such activities are continued to be fairly constrained in the current pandemic environment. In terms of how we see this moving through the rest of the year, we will, as I mentioned in my comments here, continue to invest behind launches with a focus on driving growth and good momentum going into 2022. We continue to grow our investments in R&D, as you've seen this quarter, and we will continue to grow investments in R&D through the fourth quarter and into 2022 as well. But as I say, we'll provide more detail on that when we offer 2022 guidance in February next year.

[Emma N. Walmsley, CEO & Director]

Thanks, Iain. And Brian on pricing and cost dynamics?

[Brian McNamara]

Yes. Thanks, James. I mean, first, I'd just reinforce, I feel very good about the top line growth in the business and the fact that we're seeing momentum across brands and categories from Q1, Q2 to Q3. On pricing, we have taken pricing across regions and categories. Most recently, we took pricing in the U.S. in October. In the U.S., price increases were mid- to high single digits on brands that represent about 50% of our sales, so brands like Sensodyne, Paradontax, Emergence and Tums. While it's never easy to take pricing in the U.S. environment, we had good acceptance on the pricing. We're also taking pricing across Europe and have been successful in taking pricing in China also. And maybe for perspective, in the quarter with our 10% growth, we saw about 1/4 of that growth come from price with about 3/4 coming from volume growth. And I'm confident going forward, we have the ability to take price. We have great brands to create equity, strong innovation, and that puts us in a very good position.

[Emma N. Walmsley, CEO & Director]

Yes. And the other aspect of that is the -- we're less exposed on input costs, I think, than some other consumer goods companies, both from the size of our products and I think, it's about 10% or so of the share of our sales company in that, too. So that's important to be aware of. Next question please.

[Operator]

Your next question on the line comes from the line of Peter Welford from Jefferies.

[Peter James Welford]

So sticking to the 2. Firstly, I think one for Hal. Would you comment a bit on DREAMM-5. We saw some headlines come out from your partner, SpringWorks on this. I wonder if you can just comment in terms of what you've seen in the encouraging early data with the gamma secretase inhibitor and what prompted the expansion of this study? And what we should perhaps be thinking about in terms of next steps and what you're looking for in that expansion cohort? And then secondly, just one, I guess, for just on the EPS outlook. Just to be clear, could you just outline in the sort of time you've given for EPS, does that at the moment include any COGS write-downs for the pandemic adjuvant? Or does that explain, if you like, the 7% to 9% delta? And perhaps you could just explain what the sales are of Xevudy and the pandemic adjuvant within that 7% to 9% range?

[Emma N. Walmsley, CEO & Director]

Okay. Well, let's come to Hal first and then to Iain, please.

[Hal V. Barron]

Thank you for your question, Peter. I think, as you know, the functional genomic data that we generated was very suggestive that there would be synergy between a gamma secretase inhibitor and BLENREP due to its inhibition of the cleaving of the BCMA protein from the surface of the plasma cells. And that's what was being tested in the substudy of the DREAMM-5 to see if a dose of BLENREP, which we studied at 0.9, 2 milligrams per kilogram Q3 weeks would be active on top of a GSI. We know from the DREAMM-1 study, although limited numbers of patients, that such a dose would have limited, if any, activity. And so we studied to see if the combination of a gamma secretase plus BLENREP at this low dose would induce meaningful responses. And as we said, the data, although preliminary, is very encouraging and it has led to us ungating the expansion phase of this program. And in that expansion, we're going to be comparing in randomized way so that we can get more robust data whether the 0.9 mg per kg dose of BLENREP, given Q3 weeks with the GSI, is how it compares to the standard approved dose of 2.5 mg per kg Q3 weeks in -- as monotherapy in the refractory setting.

[Emma N. Walmsley, CEO & Director]

Iain?

[Iain James Mackay, CFO & Executive Director]

Yes. On EPS and specifically, any elements coming through COGS on adjuvant sales. No, we've absolutely fulfilled the obligations and expectations for adjuvant sales for 2021 with no adverse impacts coming through cost of goods sold. As I mentioned in my comments, Peter, in terms of whether there'll be any impact in the fourth quarter, or for that matter, next year is really very much about the antigen contribution based on the outcomes of the Phase III studies that we've got going on with a number of partners, 2 of which, I think Sanofi and Medicago, we'd expect to read out in the fourth quarter and 1 in the first part of next year from SK Bio. So at this point, nothing adverse coming through cost of goods sold as it relates to that. In terms of Xevudy, we've got contracted more than 420,000 doses, and we have reserved with agreements being negotiated presently of more than 220,000 doses, those negotiations ongoing with a number of governments. You'll have noticed within the quarter, we recognized GBP 114 million of revenue from those -- from parts of those 420 contracts and not all of that 420, obviously. And clearly, Luke and the team continue to pursue contracting opportunities for this important treatment for COVID-19 aggressively because it clearly has a very beneficial effect conceivably on impact to patients. But that's really the dosage outlook that we've got in terms of contracted and reserved at this point in time, Peter.

[Emma N. Walmsley, CEO & Director]

Thanks. Next question please.

[Operator]

Your next question comes from the line of Mark Purcell from Morgan Stanley.

[Mark Douglas Purcell, Equity Analyst]

First one on RSV for old adults, time line has shifted forward from the second half of next year to the first half of next year. Can you just help us understand whether this is a function of speed of recruitment or higher implied infection rates at the trial sites? Clearly, there's competitive dynamics here with 2 other players in pivotal trials. And then secondly, there's been a little press recently around COVID vaccines and raised concerns around a relatively narrow neutralizing antibody response versus only the S protein. With national infection, you're seeing much high levels of end-protein antibodies, for example. So when it comes to sort of next-generation approaches, are you considering with your partners developing COVID vaccines against a broader range of protein targets beyond just the S protein?

[Emma N. Walmsley, CEO & Director]

Thanks. So 2 questions for Hal, please.

[Hal V. Barron]

Yes. Thanks, Mark, for the great questions. First, to talk about RSV, we're very excited about the opportunity here, of course, because of the significant unmet medical need that RSV represents with I think, as you know, more than 175,000 patients in the United States alone being hospitalized and 14,000 deaths, something that compares very, very -- in some respects, worse than flu. Our program is actually progressing very well, and the increase in time lines -- I mean, sorry, the decreased movement forward in time lines is really completely driven by operational efficiencies and our ability to enroll more aggressively. It, of course, is going to be an event-driven trial, and so events will matter. But the time line shift is simply due to better execution and acceleration. I think the second question was about COVID and the impact of neutralizing antibodies, whether they be from vaccines or endogenous infections. And I think it's an opportunity to highlight that, yes, the immune response generated from the various vaccines does differ. And as variants start emerging, the response and the neutralizing titers to each of these sub-cons is different. And this is why we're very excited about our protein with the adjuvant as a vaccine. And I think we'll have data for that in the coming months. So we're very excited to see what neutralizing antibody titers and how they compare to other vaccines that are available today because there could be, as you say, an opportunity for broader spectrum response. With mRNA, as you know, we're pursuing a collaboration with CureVac and we have a second-generation approach where we're using this so-called optimized 5 Prime 3 Prime to make sure the transcripts are more stable, and therefore, protein expression is higher. We're also exploring a version of that with both unmodified as well as modified to see what the incremental contribution of modified is. And pending that data, of course, there's opportunities to be able to explore, creating transcripts to any of the variants that emerge to be able to focus the neutralizing counters on any variant. So it's an exciting technology, and we're excited to be playing a major role.

[Emma N. Walmsley, CEO & Director]

Next question please.

[Operator]

Your next question comes from the line of Simon Mather from Exane.

[Simon Mather, Pharmaceutical Equity Analyst]

So first one for Deborah, actually. Just looking at HIV, obviously, Dovato is doing exceptionally well now, is driving new growth in disease division overall. I'm just wondering if you had any thoughts about the future potential threat from Merck's is like [indiscernible] 2 days ago, I think we saw headline results that the illuminate switch study seemed to be non-inferior to the current best-in-class treatment opportunity. So basically, just talking through the opportunity that you still see in the treated regimen and the threats that you might see from Merck would be great?And the second one, maybe for Luke. Just maybe if you could give us an update on your views around the commercial opportunity for daprodustat. And I think originally, there was very bullish expectations that HIF inhibition could offer an oral -- it was safer than ESA, obviously, from competitor data, it doesn't seem that is the case. I'm just wondering if you could maybe talk to the competitive opportunity -- sorry, the commercial opportunity for daprodustat?

[Emma N. Walmsley, CEO & Director]

Right. Well, to our commercial leaders.

[Deborah Jayne Waterhouse, Chief Executive Officer of ViiV Healthcare]

Great. Thanks for the question. So first of all, I think when we think about our portfolio, you're right, Dovato has had a very good quarter. We're really proud of our innovation leadership in the development of 2 drug regimens as investigating therapies. And I think you can see our competitors following us. And as you say, the -- there were 2 studies out this week at a headline level for Merck in 2-drug regimen in the switch setting. If we think about the label that Dovato has, basically, we have the GEMINI studies in naive after 3 years, which showed non-inferiority versus a donategravir based 3-drug regimen. Then you've got the TANGO in the switch setting, again, data after 3 years with no confirmed urologic failures. And then we've recently published our self study, which was a second switch study, which was similar to the Merck one where it was sort of an ARV versus Dovato study. And again, we saw no confirmed virological study on Dovato 3 to 48 weeks. And all that data has really, I think, led to a great deal of confidence in Dovato by physicians that you're now seeing that convert into prescribing. And we see Dovato is on all the major guidelines recommended for both naive and switch. However, I do think having a competitor coming into the market who is following on from us and is also in the future going to promote 2-drug regimens, I think it helps move the market to 2-drug regimens because if you think about the U.S. at the moment, less than 5% have converted over to Dovato. It's a lot higher than that in Europe. But it's a journey that's moving at pace, but it's probably slower than we would like to see. So I think that will be very helpful in reshaping the market and building even more confidence in 2-drug regimen. And to me, the question we should ask ourselves every single day is, why should somebody living with HIV take 3 medicines when 2 is all they need. And on that basis, I think there's a huge potential for 2-drug regimens. And I think Dovato has got a very bright future. And we'll see what our competitors bring in following on from us.

[Emma N. Walmsley, CEO & Director]

Thanks, Deborah. Luke, on dapro.

[Luke V. Miels, President of Global Pharmaceuticals]

Thanks Simon. When I think if you -- I think if we all went back 18 months ago, I don't think many people would have expected that dapro would be 1 of 1 or maybe 1 or 2 HIFs in the U.S. So I think that's driven a reappraisal of the potential for that reagent in the U.S. and also Europe. I think it's going to be driven -- the potential is largely going to be driven by the type of label that we get overall. Of course, safety being the key element there, particularly in the nondialysis population, where a number of companies with EPOS, including long-acting EPOS, have tried to penetrate that area and it's been a bit of a challenge. If you look at the numbers long term, I mean, we estimate by 2030 there would be about 8 million CKD patients who are anemic or less than 12. And on the label that we expect initially owed to, about 3 million of those would be eligible. And you got about 1/3 of that with dialysis, and this is U.S. and EU5. So the potential is certainly there, but I think it's going to depend on how the regulators treat it. I think also we're expecting publications around the ASN academic event. And I think the treatment through the editorials also would be very influential there. So very positive, but we just need to see how the frame lands. There's clearly a high demand for these products. EPOS has limitations, particularly in this non-dialysis setting. And we're very, very focused on ensuring that we make the maximum opportunity as far.

[Emma N. Walmsley, CEO & Director]

Thanks Luke. Next question please.

[Operator]

Your next question comes from the line of Graham Parry from Bank of America.

[Graham Glyn Charles Parry]

So firstly, on Shingrix, and your commentary around 2022 deferred sales, and you guided that to strong double-digit growth and record sales. If I look at consensus at the moment, that's probably pointing to GBP 2.5 billion or closer to 50% of where your current guide is. Does that fit within what you had defined as a strong double-digit envelope? And then secondly, on ROC vaccine, if you're pulling forward to first half '22 just on enrollment, could higher RSV incidents see land that data as early as Q1? And perhaps just to help us understand where you see a differentiation now that you've started to see more data from the competitors in the clinic with data from Pfizer, J&J and Moderna all out there now, particularly in terms of the implications of your adjuvant, but also not targeting RCB with your vaccine?

[Emma N. Walmsley, CEO & Director]

Thanks, Graham. Well, we're not going to outline specific guidance for Shingrix in '22 today. But Luke, it may bear you just reiterating some of the underlying both consumer and commercial dynamics on that. And then let's hear both from Hal on the overall kind of underpinning scientific differentiators, but also I think it would be good to hear from Roger on how we see the prospects of the RSV market playing out. But first to Luke, please.

[Luke V. Miels, President of Global Pharmaceuticals]

Sure. Thanks, Emma. Thanks, Graham. I mean, if you look at demand for Shingrix in the second half of this year, it's been clearly correlated with outbreaks of delta, which, I mean, is -- I think is logical. I mean, people don't want to go into retail pharmacies if there's a delta outbreak in the area. And we follow that at a state level each week, and the pattern is very, very clear. Now what is interesting is when we look at leading indicators like, for example, Google searches at the highest level we've seen for shingles in the last couple of weeks. If you look at the script trends that we're now starting to see, these are also very encouraging. And a key point on the script trends, and I mentioned in my commentary at the start, we -- when we saw the impact of COVID vaccines and just the need for retail pharmacy to deploy infrastructure and staff to give those vaccines, we made a decision and it was a risk at the time, but it's played out, to promote Shingrix in the second slot on the Trelegy team targeting HCPs in their offices. And normally, that's about 1/3 of shot that are given HCPs and about 2/3 of retail. What we're seeing right now is that's more 50-50, which means that you see an underreporting of the TRx levels because they're more efficiently captured in retail. So these are all encouraging. Emma mentioned the market research that says when we ask people who've been vaccinated for COVID, so they tend to be motivated adults. They list Shingrix as their second vaccine they want to get after flu. So these are all pointing in the right direction. I think if you look outside the U.S., we'll be in 17 markets at the year-end with 35 added over the next 3 years. We had a very strong start in Germany. That was disrupted by COVID vaccines and outbreaks that is now returning. I expect Germany to be the second largest market next year. So these are all the elements that underlie our confidence there.And people may have questions around the inventory. The inventory is very much in the range that it's been historically. In the past, we've seen it drop down to, say, 0.5 million, 0.7 million doses. But the range it normally stays in is just over 1 million, and we have a lot of heritage managing that very tightly because of the past supply problems. So right now, it's very much within the 1 million doses, very much under control. And our feedback from retail pharmacists and ACPs has continued demand. So I think the hypothesis of the demand remains robust.

[Emma N. Walmsley, CEO & Director]

Thanks, Luke. And Hal, and then Roger, please on RSV.

[Hal V. Barron]

Yes. Thanks, Graham. We're very excited about the RSV program and the changes we've made in the development organization to be able to speed this up from an operational efficiency perspective. But as you point out, there's other contributors to when we'll be able to see the data, including event rates. We are -- so that is one of the dependencies to see how many events we have. And I should say the third aspect of when we'll be able to see data is driven by being able to see the duration of the effect. So making sure we have a broad section of the season so that we can understand the effect over time. And all 3 of those things go into one, we will see data. But we're confident it will be in the first half now. As far as differentiators, we see this as very important component of why we use the adjuvant. If you think about this disease, it's really prominent in those over 65 because as you age, your immune system becomes somewhat less able to mount the appropriate B cell response, the neutralizing antibody titers, but also to mount an effective T cell response, the cellular immunity. And what we've seen over and over in vaccine development with other diseases and what was confirmed in our Phase II data is that the adjuvant that we're using is actually very effective at sort of normalizing, if you will, the T cell response. And when you look at some of the competitors that don't have that, it's not clear from the data generated whether the immune response that's generated in the elderly will be as effective as the one we can generate with an adjuvant. So we see that as a differentiating feature. It's not just true with this vaccine, but our whole adjuvant platform. The other point is that we have looked very carefully at the neutralizing levels of -- neutralizing antibody levels towards both RSV protein A and B, the different epitopes of the 2 viruses, and we see a very effective neutralizing antibody to both the pre-F fusion protein. So we are expecting that we'll be very effective at both variants. And as I said, with the adjuvant being able to mount the T cell response, which we think will both have a broader antibody spectrum as well as possibly a greater duration of effect, leading to a differentiated vaccine on that. So pleased about the speed, pleased about the science and hopefully, we will see that translate into a very effective vaccine quite soon. Roger, do you want to add a little more to that on the commercial side?

[Roger G. Connor, President of Vaccines & Global Health]

Yes. Just very quickly, Hal. I think you touched on the excitement. We've got -- the market size here is really significant, 1 billion people, more than 60 years old. We believe there is a major opportunity. I don't think people have really realized again that the hospitalization burden on this is higher than flu. So we have a real opportunity, we believe, to come in and take a significant part of what is a big market as well. A couple of points that we'll be looking at to potentially drive differentiation, duration of protection, as Hal mentioned, linked to that adjuvant as well.I wouldn't underestimate the importance of our CFD record on our ASO1 adjuvant as well. We have now given this to more than 25 million people as well. So again, building off the Shingrix history there. And we knew the older adult market through Shingrix as well. So that's another positive that we want to apply. Just quickly on supply as well, we're investing at PS in advance to be ready for this vaccine as well. We obviously stepped in Shingrix capacity recently. This is the same technology platform. We've got a double benefit by improving Shingrix. We also got a step in our RSV capacity as well, which is good, which means that we're going to be ready for this launch as well.

[Emma N. Walmsley, CEO & Director]

Right. So next question please.

[Operator]

Your next question on the line comes from the line of Seamus Fernandez from Guggenheim.

[Seamus Christopher Fernandez, Senior Analyst of Global Pharmaceuticals]

Great. So I just wanted to go back to the gamma secretase. Just hoping you could help us understand when you might be sharing the combo data that you have so far? And how you see the combos fitting in relative to some of the other Phase II expansions that you've started? I just note the DREAMM-14 study has a number of different doses and schedules with BLENREP. And then my second question is really on the process of the demerger itself. There has been some speculation and questions around the value of potentially shifting gears to an IPO. Just wondering if you could either confirm or deny that possibility? It seems like you're quite far down the path with a straight demerger spin and just hoping to get a little bit of clarity there given some speculation in the market?

[Emma N. Walmsley, CEO & Director]

Yes, Seamus. So I can be really quick on your second question and then hand back to Hal on BLENREP. But just to repeat what I've already said, we are very committed to the demerger of at least 80% of our holding. We've had very positive levels of interest from our shareholders. And then we are looking at a timely and pragmatic monetization of the remaining up to 20%. And we are on the runway and we're really focused on executing that brilliantly. So Hal, over to you on the various approaches to maximizing BCMA.

[Hal V. Barron]

Yes. Thanks, Seamus. When you look at the strategy we have for maximizing the opportunity for BLENREP in patients, it's important to remember that the risk benefit for myeloma patient changes according to the line of therapy that we're studying. So when we think about studying the second, third line patients, such as in DREAMM-3, DREAMM -- where we're going ahead to that with pomalidomide; DREAMM-7 and 8, where we're going head-to-head with Velcade and DARZALEX, we're doing a number of things. First of all, we're trying to be superior to pretty effective standard of care. And in that setting, we're really focusing on optimizing efficacy. As we think about trying to reduce some of the ocular toxicity that we're seeing, we really have a 4-pronged approach of which gamma secretase plays 1 role. But we're really looking to see if we can lower the dose, as we've seen in the Algonquin study, 2 doses like 1.9 mg per kg, where when we give it with standard of care therapy, such as pomalidomide and other drugs that are approved. And we think that by lowering the dose, we might be able to reduce ocular tox. We also know that there's an opportunity, and we'll be seeing some of this data later this year, on the impact of changing the schedule. And by that, I mean moving from a Q3 week to a Q4 week, maybe even a Q6 week or even Q8 week dosing regimen where the peak trough ratio changes and exposure changes in a way that we hope might reduce ocular tox. And of course, we have the opportunity to think about how we alter the schedule as it relates to dose holding. Currently, the approved regimen as demonstrated in the program on DREAMM-2, we tend to hold the dose when patients develop -- whether they're symptomatic or not, Grade 3 caratopathy.There's an opportunity to alter that holding pattern to, say Grade 2 caratopathy, to prevent the further development. And so we're exploring those 3 different levers, if you will, on how to optimize in combination with this very intriguing concept of being able to lower the dose by inhibiting gamma secretase, which, as I mentioned earlier, is responsible for clipping of the BCMA off the plasma cell and by inhibiting that, increasing expression, and by doing so, maybe allowing equivalent efficacy at a lower dose. So those are the 4 levers to reduce ocular tox and, of course, at the same time, designing trials to show superiority in head-to-head trials, like I mentioned in DREAMM-3, 7 and 8. So a number of different strategies all being modular, to some extent, and depending on the patient population, the concomitant meds and most importantly, the line of therapy, we're mixing and matching those to optimize the program.

[Emma N. Walmsley, CEO & Director]

Thanks Hal. Next question please.

[Operator]

Your next question comes from the line of Andrew Baum from Citi.

[Andrew Simon Baum]

A couple of questions. Emma, I was listening very carefully to your comments at the beginning of the call. And you described GSK as being agile in terms of COVID opportunities. One of your existing partners in Viva, very long one has a novel non-boosted protease inhibitor for COVID. I'm just intrigued if you'd care to comment on the relative level of interest given Shionogi has talked to partnering the asset with a global partner, and it's difficult to think of someone better equipped than GSK. Second, again, listening to your answer to the question about private equity and the story that was on Bloomberg last week, you have juxtaposed your response about timely monetization of your stake at the IPO or the sale of stock from GSK that you don't demerge potentially creates [indiscernible] until it's put into the market. Are there potential creative solutions one may think about? And I'm particularly thinking about PE by which [indiscernible] could be taken away and yet GSK could have access to capital early in order to facilitate business development?

[Emma N. Walmsley, CEO & Director]

Yes. Well, Andrew, my reference to agility on COVID was, frankly, because it was less about -- and I'm not going to comment any specific potential additional partnership or not. But it was much more about how the environment around COVID vaccination continues to change as data emerges all of the time. Obviously, the first question is how do you contribute to the pandemic? Then the question is what is the shape of an endemic-specific market for COVID? And then the question is how do we all learn and how will GSK continue to lead the way in terms of a broad technology platform? And it's that kind of agility to make sure we keep adjusting and the thoughtfulness on how we're approaching mRNA as Hal outlined earlier in terms of looking both the proof of the platform within COVID because you can imagine a better global data set than we have now, both on a modified and unmodified basis, and then also looking at potential combos. We have said we're looking to be in the clinic around COVID and flu by next summer. And then we've got, I think, another 6 possibilities over the next 4 years. So lots of learning continuing on mRNA opportunities, and that's where we want to bring our agility. I think it would be fair to say that the global level of supply around pandemic vaccines, even if such low percentages of the developing world have vaccinated so far has surged a lot. So I don't think that's so much the primary question, although obviously, we'll be thrilled to contribute not least through COVAX as our pricing adjuvant readouts come. And there we're dependent on our antigen partners in terms of their capacity to supply. And on your other question. I mean, 1 of the key reasons for retaining up to 20% was precisely as you referred to the additional opportunity beyond the initial deleveraging with the transfer of that to further strengthen our balance sheet and be able to keep investing in our #1 priority. We've said in a timely and pragmatic manner, and that will be timely and pragmatic all about maximizing value. I have to say, in terms of the prospects of the consumer business, we really do feel confident that this is going to be an appealing stock, and hopefully, we'll bring a lot more visibility to that in Q1.Next question please.

[Operator]

Your next question comes from the line of Laura Sutcliffe from UBS.

[Laura Sutcliffe, Equity Research Analyst]

Could you help us understand how Shingrix is working in the real world in the retail setting at the moment a little bit further? So if a patient who's receiving a flu vaccine or a COVID vaccine makes it as far as the retail pharmacy, are they a person who is a likely candidate to get Shingrix at that time or someone who is avoiding getting Shingrix at that time? And then for Deborah on HIV, the -- on your third-generation integrase inhibitor with Shionogi, could you tell us what routes of administration you think might be possible for that molecule?

[Emma N. Walmsley, CEO & Director]

Right. So Luke and then Deborah, please.

[Luke V. Miels, President of Global Pharmaceuticals]

Sure. So Laura, great question. I mean, if someone presents seeking a COVID-19 vaccine, I think the key parameter is just a history of adult vaccinations in the past. So if there's someone that regularly came for a flu shot, then they're likely to be more receptive on the part of the pharmacist. It depends then on how much time that individual has at that point and also how busy the pharmacist is. Of course, if there's 10 people lining up for a COVID shot, then the opportunity to discuss the benefits of being vaccinated by Shingrix is less. In that case, though, the retail pharmacists have incentives through the major change in the U.S. to rebook that patient to come back to the retail pharmacy on another day and receive that vaccination. Or they can give those doses concomitantly, which ACIP has indicated they're comfortable with. We're also running a study with Moderna's COVID vaccine that we'll read out in Q1 of '22, just to build some more evidence around that co-administration. And then the other trend, which I think is just encouraging that I didn't mention earlier is around 7 out of 10 shots right now for Shingrix are the first shot, and we know 90% of people so far come back for the second shot. So it's their history of vaccination and how much time does the individual have and the pharmacists have, and then usually the aim is to rebook them to come back.

[Emma N. Walmsley, CEO & Director]

Thanks, Luke. Deb?

[Deborah Jayne Waterhouse, Chief Executive Officer of ViiV Healthcare]

Great. Thanks, Laura. So our current and future portfolio has integrated inhibitors at the core. And they really are the proven gold standard of therapy in the field today, and we believe in the future, they're supported by guidelines, by a significant amount of really strong data. And you've got, I think, more than 18 million people with HIV today taking a second generation integrase inhibitor. So our kind of core belief is that if you're going to be successful, it's very important to have a strong and robust integrase inhibitor at the core of your regimen. So then if I think about what Shionogi offers, the Shionogi-integrate inhibitor has the potential to be ultra long acting, and it will also have a unique resistance profile. So by the time we get to 2030, undoubtedly, some resistance will have emerged to the second-generation integrators such as dolutegravir and bictegravir. So this unique resistance profile is going to be very, very valuable. We believe the opportunity to really harness the ultra long-acting potential is to have it as a subcutaneous or an intramuscular. And so what we will do as we now start the development journey of that medicine is to explore both of those options, but we don't see it as an oral, we're very much looking at it as a subcut or an intramuscular injection.

[Emma N. Walmsley, CEO & Director]

Thanks Deborah. So I think we have time for one last question today. And obviously, we can do lots of follow-up with you afterwards. But time for one last question, please.

[Operator]

Your last question on the line comes from the line of Kerry Holford from Berenberg.

[Kerry Ann Holford, Analyst]

Two questions, please, on Zejula. Luke, I think you said diagnosis rates, any barriers still around 15% below pre-pandemic level. Are you seeing any signs of improvement here now? And is this something you expect to normalize this year? Or are you going to move into next? Essentially, when do you expect a step change in the Zejula sales growth trajectory? And then just on Benlysta, perhaps a question about any thoughts on why the Phase III BLISS-BELIEVE study failed to show any incremental benefit from the Benlysta mono enzymes?

[Emma N. Walmsley, CEO & Director]

Let's go to Hal first and then finish with Zejula.

[Hal V. Barron]

Kerry, thanks for the question. I think the simplest answer is that Benlysta was a backbone for both arms, of course, and is a very effective therapy for these patients with lupus nephritis. And essentially, rituximab in the single dose and the manner it was given, just didn't add anything to Benlysta's very effective management of these patients.

[Emma N. Walmsley, CEO & Director]

Right. Luke?

[Luke V. Miels, President of Global Pharmaceuticals]

Thanks, Kerry. I mean, I think -- I mean, we're actually hoping to see a recovery by now, but then we saw the Delta version emerge. And on Slide 26 in the appendix, we put the IQVIA data there just showing that relationship. Now surgery did go up in August. We expect that after restatement. But you can see, obviously, we hadn't got through the peak of Delta in the U.S. in August. So hopefully, as we go into the Northern Hemisphere winter, we see a reduction, and with the booster, a reduction in the number of cases and more of these women present to their GPs and then diagnosed. Of course, ovarian is a very difficult tumor to diagnose because the symptoms are quite diffuse. So that's the challenge. The downstream effect then, of course, is typically they'll have 6, 7 cycles of chemo. So from that initial debulking event, it's going to take another 6 months before they present to maintenance. What we don't know is are these women going to be, by virtue of being diagnosed later, more progressed in their disease, so likely to relapse faster, and therefore, compress the total period of which they're treated with a maintenance therapy. So it very much remains unknown. When we do look at the patients that are coming through and being diagnosed, as I said earlier, we are very, very competitive in those new and emerging patients and continue to be so and continue to make the argument for the benefits of Zejula over the alternatives.

[Emma N. Walmsley, CEO & Director]

Thank you. So look, in conclusion, it's a quarter where we've continued to deliver evidence that the hard work of the transformation program over the last 4 years is generating results. We've got strong business performance, double-digit sales growth in Pharma and Vaccines and increased momentum in Consumer Health. And that's allowed us to upgrade the full year guidance. And alongside the progress in strengthening our pipeline, reinforces our confidence in the outlook for a step change in growth and performance from 2022 and beyond. And at the same time, we're very excited about the progress towards unlocking all the shareholder value with a successful demerger in mid-2022, which is going to be a landmark year for our company. Thanks very much, everyone. Look forward to following up with you in coming days.

[Operator]

For all the speakers, that concludes your conference call for today. You may disconnect. Thank you for joining, and enjoy the rest of your day.