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

Thank you, Operator. And good morning and good afternoon. As you've just said, 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. 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 usual safe harbor statements and will be making comments from performance using constant exchange rate or CR. Please turn to slide 3. This is today's agenda where we'll try to cover all aspects of our results. The presentation will last approximately 25 minutes in order to maximize the opportunity to questions.

For those on the phone, please join the queue by pressing star 1 and we request that you ask a maximum 2 questions so that everyone has a chance to participate. Our speakers today are Emma Walmsley, 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 [Indiscernible]..

Fine, 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% of CEO.

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 [Indiscernible] 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% 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 [Indiscernible] 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 weight. The B merger and creation of a world leader and 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 UK.

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 changing in growth in 2022, an exciting and important year for our Company. Turn 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 listed on the slide.

Among them, I'm also delighted we're now playing a meaningful role in the COVID-19 response through our antibody treatment, Xevudy, with several COVID-19 vaccine programs seem to readout, and we remain agile as the environment continues to evolve. And 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 as a 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 then consumer strong brand performance also drive a significant acceleration in growth in the quarter as [Indiscernible]. Lastly, on trust, we continue to maintain leadership in ESG with the recent announcement of significant renewable energy investments in carbon reduction initiatives at our manufacturing sites in the UK and U.S.

We also announced the new R&D program to reduce greenhouse gas emissions from 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 0 and nature positive by 2030, which we'll share more on 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'll take a moment to expand on my comments on innovation. On our investor update in June, we shared how we did significantly improved R&D productivity since 2017. For the top quartile performance versus our peers for the number of launches with the approval of 11 major [Indiscernible].

We've more than doubled the number of assets in Phase 3 of 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, eventually a number of readouts and regulatory [Indiscernible] support the confidence we have in the outlooks we provided for GSK in June.

Specifically, we expect to report key readouts on up to 7 of the 11 assets we highlighted, including our older adults are as feedback seen in the first half of 2022, as well as proof-of-concept data on our potential HP therapeutic.

And we're planning a regulatory submission for blend and third line multiple myeloma, and as I mentioned previously, you're going to hear a lot more on DAP produce at ASN Kidney Week and our investor science event, which is also scheduled for early November. Please, on slide 8.

Lastly, I want to take I've been on the timelines, the demerger of our world-leading Consumer Healthcare business. We are in countdown mode and moving at pace with our plans to unlock the potential of both GSK and Consumer Health, strengthened GSK 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 want 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 out in detail the performance and compelling prospects for Consumer Health as a new and independent Company.

We will then proceed with a 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 from 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..

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 inhaler 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 that a clear and targeted approach to eos -driven disease is preferred, and we remain confident in Nucala 's market opportunity as we launch 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. Convenient subset formulation and lupus nephritis indication in the U.S. build 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 and 2 new POP patients receiving Zejula despite a tough external environment where unfortunately, diagnosis remain about 16% below pre - Covid levels.

Encouragingly, and based on new patient stock data, we're also seeing [Indiscernible] as the preferred choice to new patients across 3 lines with European. But 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 two pivotal studies, drain 3 and drain? 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.

was also encouraging with a 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 comparative in Q4 hit and prioritization of COVID-19 booster vaccinations in the near-term, we now expect the year-to-date performance, which is modest 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.

A 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 multi-channel direct-to-consumer campaigns, engaging healthcare providers, and further strengthening our relationships with U.S. retailers. Looking ahead, we continue to launch a new markets with our unconstrained supply position, and we expect continued U.S.

recovery as we work through COVID 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, predicting more than 100 million adults along the way. Now, let me hand over to Deborah. Please turn to slide 12..

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 wholesale purchasing patterns in the U.S. and 2% by the growth dependent in the international region.

Strong commercial execution is driving performance at the innovation products which now represent 29% of total portfolio delivering almost PS1 billion of sales year-to-date. Dovato, in particular, continue 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 Cabotegravir, the world's long acting injectable treatment for HIV.

As of any new type of medicine, Cabotegravir will take time to build and the COVID environment continues to constrain which activity, particularly where a patient needs to visit a physician's office. We have robust lead indicators with about 80% market access, and strong brand recognition.

More than 2,000 people living with HIV are now taking Cabotegravir and intend to prescribe levels are high. We are very excited about the potential approval 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 [Indiscernible] granting Priority Review status, which builds upon its priorities application, a break-through therapy.

We believe this underscores the importance of this medicine, supported by the results of the HPTN studies, which demonstrates the Cabotegravir's superior efficacy over daily oral STC, TDS tablet -- TDS tablets.

In the United States, fewer than 25% of those who could benefit from PEP-PrEP 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 updates in June, we expect our non-GAAP and portfolio of Cabotegravir long acting for prevention to generate sales of around a million pounds by 2026.

We will take particularly proud to announce the new collaborations with our longstanding partner, Shinogi, 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 play -- to slide 13..

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 rate 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 of double-digit and with China and Middle East and Africa standout performers. Let me provide some color on our category performance. All our health sales increased 5% reflecting continued good execution and successful innovation.

Pain relief was up double-digit helped by easy competitors last year, and strong double-digit growth in brands including Advil and Panadol more than offsetting a low single-digit decline in Volterra. The Volterra decline was expected given the entry of private label into the category following the successful U.S. RXOTC switch last year.

Vitamins, minerals, and subsequent 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 competitors 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 operating margin.

Innovation continued 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 roll-outs. 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 to 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 two 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..

Thanks, Brian. As I cover the financials, references to growth are 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 9.1 billion pounds up 10%, and adjusted operating profit was 2.9 billion tons up 16%.

Total earnings per share was 23.3 tons up 3%, while adjusted earnings per share was 36.6 up 10%. And the year-to-date turnover was 24.6 billion pounds up 3%, and adjusted operating profit was 6.9 billion tons up 8%. Total EPS was 72.7p down 19%, and adjusted EPS was 87.7p up 5%.

In currency, there was a headwind of 5% of sales and 7% in adjusted earnings per share, in particular due to the strengthening of sterling against the US dollar relative to the third quarter of last year. Slide 16 summarizes the reconciliation of our total to adjusted sales.

The adjusting items note for the quarter was intangible impairments, which primarily reflected the results and determination of the agreement with Merck KGaA on Bintrafusp Alpha. My comments from here onwards are an 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 centered here. 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. Result in Q3 margin was 31.7% and year-to-date margin 8.1%.

We now expect R&D to grow high single-digits in the full year, reflecting upskilled investments balance from the continued realization of efficiencies with our approach to one R&D. Moving to 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 TDS tax authorities. We still expect the full-year effective tax rate to be around 18%. We also still expect interest expense to be between 800 million pounds and 850 million pounds.

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 1.5 billion kinds of free cash flow.

The main posted factors were increased adjusted operating profit at constant exchange rates, lower dividends to non-controlling interest, 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 Alector and iTeos.,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 in Slide 20. Overall, pharmaceutical revenues grew to 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 3 percentage points of growth. And 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 climb 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 reflect 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-year comparative included the recognition of pre -launch inventory for Blenrep, which was a credit of slightly over 13 million tons. 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 we 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 and 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 mid-term expectations for the vaccines business, so we continue to be very confident in the demand for our products and high single-digit growth outlook. Notably with regards to the Shingrix, where we've said 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 increase R&D investment of 46% as we progressed our RSV and Meningitis development programs and invested in our MRNA plus.

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 are under review. Including those brands, turnover grew 8%, and Brian outlined the main drivers earlier. In year-to-date revenues excluding brands either divested, are under review in [Indiscernible].

The operating margin for Q3 was 25.9% up 420 basis points at constant exchange rates versus last year. Year-to-date operating margin was 23.6%. Consumer in the full year, excluding brands divested are under review, we continue to expect lower to mid single-digit percentage revenue growth. Turning to Slide 23. Considerations for 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 MiSeq and -4% in constant exchange rates, excluding the impact of COVID solutions.

We also 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 action contracting for 2022, and the resulting potential charges within cost of goods sold as we continue to manufacture for this potential.

Key factors that includes Q4 where we deliver in the full-year rate, will continue to be the friend and adult vaccination rates within the context of COVID-19 -- of the COVID environment, The relative phasing of launch investments to generate future growth, and 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 [Indiscernible]. We hope you will be able to join us for these events.

In summary, we believe the business momentum from an 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 posted momentum.

With that Operator, we're ready for Q&A..

Thank you very much. Your first question in the queue comes from James Gordon from JP Morgan. You are live in the call. Please go ahead..

Hello, James Gordon from JP Morgan. Thanks for taking the questions. First question is on OpEx. So to reiterate your comments about meaningful operating margin expansion next year, but SG&A was 5% below and already 8% below our expectations today.

The question is, how much is low OpEx about cost avoidance versus structure changes at the Company? And as we look into next year from the high er base, when you talk about meaningful expansion, can you just 100s basis points of EBITDA margin expansion next year? Or could it be a bit of catch up if things get back to with COVID and you have to stop spending more.

So that's the first question, please. Second question was about Consumer separation. A couple of weeks ago, Greenberg was reporting that the Consumer Division could attract bids from PE firms or other pharma 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've described, or is that story inaccurate or [Indiscernible] happen historically, and it's definitively just the separation process described.

And I actually [Indiscernible] a clarification, I saw a comment about price range of the US consumer. Are you able to tell us what the price or it is all that you put through in October in consumer, and how do you see the pricing power of the business go-forward, please..

Great. Thanks. Thanks very much. 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 are 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, and 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 it's fiduciary duty, 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's going to be with guidance for 2020.

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..

I hate it's all predictable. James, thanks for your questions. We will absolutely provide detailed outlooks for 2022 in early February '22 when we get there.

On your OpEx questions, 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 it's just a very strong focus we've gotten time cost control across really every line within the P&L, whether it's within our cost of goods sold and great products, both within the far block, 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, continuing 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's how and his team have been living.

There is 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 continuing 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 investment into non A and D through the fourth quarter and into 2022 as well.

But as I say, will provide more detail on that when we offer 2022 guidance in February next year..

Thanks Iain and Brian on pricing and cost [Indiscernible]..

Yeah. Thanks, James. I mean, first I 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, then Q3. On pricing, we have taken pricing across regions and categories. Most recently, we took pricing in the U.S. in October. And the U.S.

price increases were mid-to-high single-digits on brands that represent about 50% of our sales, so brands like Sensodyne, Parodontax, Emergen-C, 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 a quarter of that growth come from price with about three quarters coming from volume growth. And I'm confident, going forward, we have the ability to take price. We have great brands with great equity, strong innovation, and that puts us in a very good position..

Yeah, and the other aspect of that is we're less exposed on input costs. I think the num some other consumer goods companies buy from the size of our products and things, but 10% reserve share of our sales come about to so, that's important to be aware of. Next question, please..

Thanks very much. Your next question on the line, comes from the line of Peter Holford from Jefferies ph. You're live in the call. Please go ahead..

Thanks for taking my questions. So seeking to firstly, I think will how just wonder if you can comment a bit on dream five. We saw some headlines about on from two partners spring books of this.

Would, if you can just comment in terms of what you see in the encouraging early data with the Cabot secretase inhibitor, most probably to the expansion of this study.

What we should perhaps you're thinking about in terms of next steps of what you're looking forward and that's expansion cohorts, And then secondly, just want -- I guess for Iain, just on the EPS outlook.

Just to be clear, could you just outline in the time you've given for EPS, does that at the moment include any talks, write-downs, for the pandemic adjuvant, or is that -- does that explain, if you like, the 7% to 9% Delta. And perhaps you could just explain what they say, applied sales are of...? pandemic adjuvant within that 7% to 9% range.

Thank you..

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

Thank you for your question Peter.

As you know, the functional genomic data that we generated was very suggestive that there would be synergy between a gamma - secretase inhibitor and blend rep due to its inhibition of the cleaving of the BCMA protein from those surface plasma cells, and that's what was being tested in the sub study of the dream five to see if a dose blend rep, which we studied at 0.92 milligrams per kilogram, Q3 weeks would be active on top of a GSI.

We know from the dream one study, although limited numbers of patients that such adults would have limited if any activity? We studied to see if the combination of a gamma-secretase plus blend rep at this low dose would induce meaningful responses, And as we said, that the data, although preliminary, is very encouraging and it has led to us on getting the expansion phase of this program.

And in that expansion, we're going to be comparing it in randomized way so that we can get more robust data, whether the 0.9 mgs per kg dose of BLENREP given 2, 3 weeks with the GSI is how it compares to the standard approved dose of 2.5 mgs per kg 2, 3 weeks in a -- as monotherapy in the refractory setting..

Iain..

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 sale sold.

As I mentioned in my comments, Peter, in terms of whether there will 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 a readout in the fourth quarter and one 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 a PS114 million of revenue from those -- from part of those 420 contract, and all 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 impacted patients. But that's really the dosage outlook that we've got in terms of contracted and reserved at this point in time, Peter..

Thanks. Next question, please..

Thank you very much. Your next question comes from the line of Mark Purcell from Morgan Stanley. You are live in the call. Please go ahead..

Thank you very much for taking my questions. First on RSV for old adults. Timelines shifted forward from the second half of next year to the first half of next year.

Could you help us understand whether this is a function of speed of recruitment or higher implied infection rates at the trial sites, and could it 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 the relatively narrow neutralizing antibody response such as the S-protein. With natural inflection, you're seeing much high-levels of event and protein antibodies, for example.

So when it comes to sort of next-generation approaches, are you considering with your partners developing COVID vaccines against the broader range of protein targets beyond just the S-protein. Thank you..

Thanks. Two questions to Hal, please..

Thanks, Mark, for the great questions. First to talk about RSV. 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 a 175 thousand patients in the United States alone being hospitalized and 14 thousand deaths, something that compares very, in some respect towards been flu. Our program is actually progressing very well.

And the increase in timelines, I mean sorry, the decrease movement forward and timeline, is really completely driven by operational efficiencies and our ability to enroll more aggressively. Of course, is going to be an event-driven trial and so events will matter, but the timeline 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 you have the immune response generated from the various vaccines does differ.

And as variant s start emerging, the response and the neutralizing titers to each of these sub components 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 are pursuing a collaboration with CureVac, and we have a second-generation approach where we're using this so-called optimized five-prime, three-prime to make sure the transcripts are more stable and therefore protein expressions 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 variances that emerge, to be able to focus -- the neutralizing Convers on any variance.

So it's an exciting technology and we're excited to be playing a major role..

Next question, please..

Thank you very much. Your next question comes from the line of Simon Martha from Exane. You are live in the call, please go ahead..

No. Thank you, everybody for taking the questions. So first one's for Deborah, actually. And just looking at HIV, obviously developers are doing exceptionally well, now it's driving new growth in the ViiV division overall. I'm just wondering if you have any thoughts about the future potential threat from dolutegravir.

I think two days ago I think we saw headline results that Aluminite switched to these seem to be non-inferior to the current best-in-cost treatment opportunity. So basically, just talking through the opportunity that you still seeing the 2 drug regimen and the threat of so you might see from, could be great.

The second one maybe for Luke, just maybe if you could give us an update on your views around the commercial opportunity for dock produced. I think originally, this are very bullish expectations, but it's an negation could offer and all helps them to site for the Obviously, competitive edge doesn't seem that is the case.

I'm just wondering if you could maybe talk to the competitive today opportunity charting the commercial opportunity for that produce stuff. Thank you..

Right, won't talk much leaders..

Great, thanks for the question. So first of all, I think, when we think about Apple 30, and you're right about it. It's had a very good quarter. We're really proud of our innovation leadership in the development of two-drug regimen in the mortgage therapies.

And I think you can see our competitors following us, and you say, the -- those studies out this week. The headline level for Merck in two-drug regimen in the switch to that setting.

If we think about the label that DevOps has, basically we have the Gemini studies in naive out to 3 years, which had non-inferiority that's it Dolutegravir-based three-drug regimen. Then you got the time guys in the switch testing. Again, days dropped to 3 years with no confirmed virologic failures.

And then we recently published our SALSA study, which was a second switch study, but to a similar stomach from where it was an ARZ that is to monetize study. Again, we saw no concerned theological, studies of off -take 3-48 weeks.

All that data has really I think led to a great deal of confidence in Devanto by physicians that you now seeing not convert into prescribing. And we see the Devanto It's 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 gone from us on this also, really in the future going to primate to drug regimens, I think it helps move the market to drug regimens because if you think about the US, the moment, less than 5% have converted over to we devour to high than not 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 would be very helpful in reshaping the market and building a more confidence in two-drug regimen.

And to me, the question we should ask ourselves, every single day is why somebody living with HIV type 3 medicines when two is all they need an will not based stocking has a huge potential to drug regimens and I think Devops a very bright future. We'll see what our competitors bring in following on from us..

Thanks, Deborah, Luke, on dapro..

Thanks, Simon. I'm going to think if you -- if we all went back 18 months ago, I don't think many people would have expected that dapro would be one of one or maybe one of two hits 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 non-dialysis population where a number of companies with E pose, including long-acting, E poses, we've tried to penetrate that area and it's been a bit of a challenge. If you look at the numbers long term, we estimate by 2030 that the about 8 million CKD patients who are nay mix are less than 12.

On the label that we expect initially outside that 3 million has to be the eligible. You got about a third of that with dialysis and this is U.S. and EU5. 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 to also 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 have limitations, particularly in this non-dialysis setting.

And we're very focused on ensuring that we make the maximum opportunities from this product..

Thanks Luke, Next question, please..

Your next question comes from the line of Graham Parry from Bank of America. You are live in the call. Please go ahead..

Great. Thanks for taking my questions.

Fiscally on Shingrix in your commentary on 2022 deferred sales, and you guided that the strong double-digit growth and record sales and if I look at consensus at the moment, that's probably pointing to 2.5 billion or close to, 50% of where your current guide is, does that fit within what you define as a strong double-digit envelope, and then secondly on RC vaccine, if you're pulling for to first-half twenty two, just on enrollments, could higher RC incident see that land that they saw early as key 1 and perhaps just help us understand where you see differentiation now where you've started to see more data from the competitors in the clinic with days from Faiza, J&J, Moderna all out there now, particularly in terms of the implications of your adjuvant, but also not targeting our CB with you a vaccine? Thank you..

Thanks, Graham. Well, we're not going to outline specific guidance for Shingrix in '22 today, but Luke 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 we could hear from Roger on how we see the prospects of the RSV market playing out. But first, to Luke, please..

Sure. Thanks Emma. Thanks, Graham.

I mean, if you look at demand for the Shingrix in the second half of this year, it's been clearly correlated with outbreak of Delta, which I mean is -- I think is logical and the people don't want to go into retail pharmacies, if there's a deal throughout break in the area and we follow that at a state level each week, and the patent its very, very clear.

Now what is interesting is when we look at leading indicators like, for example, Google search tools, churches of the highest level were seeing 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 staff to give those vaccines, we made a decision and it was a risky 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 a third of shots that are given are HCPs, and about two-thirds of retail. What we're seeing right now is that's more 50-50, which means that you see an under-reporting 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 the second vaccine they want to get after flu. 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 three years. We had a very strong start in Germany, that was disrupted by COVID vaccines and outbreaks that is now returning. Germany bid the second match market next year. These are only elements that underlie our confidence there. 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 dropped down to say point 5 point 7 million doses. But the range at normally stays in is just over a million.

And we have a lot of parakeet managing that very tightly because of the past supply problems to right now it's very much within the million doses, very much under control and feedback from retail pharmacists. and 80 pages is continued to mind. I think the hypothesis of DMARD demand remains robust..

Thank Logan and Hal and then Roger..

Thanks, Graham. We're all 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 of that rates.

We are -- so that is one of the dependencies to see how many events we haven't. And I should say the third aspect of when we will be able to see data is driven by being able to see the duration of the effect. of the -- making sure we have a broad section of the season so that we can understand the effect over time.

And all three 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 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 somehow less able to amount 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 effective as the one we can generate with an adjuvant. So, we see that as a differentiating feature, it is 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 -- the different epitopes of the two viruses and we see a very effective neutralizing antibody to both, by the Priya fusion protein.

So we are expecting that will 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 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..

Yeah. Just very quickly highlight. I think you've 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 really realize again that the hospitalization burden on this is higher than flu. So we have real opportunity.

We believe to come in and take a significant part of what is a big market.

as, as well a couple of points, DAP, we'll be looking at to potentially drive differentiations, regional protection, as Hal mentioned, linked to that adjuvant as well. I wouldn't underestimate the importance of our CFD record on our ASO adjuvant as well, we've now given us the more than 25 million people as well.

So again, Singling off the Sync-Rx history there and we knew the old Rabo market through Sync-Rx as well, south and Dillard, positive that we want to apply just correctly on supply as well. We're investing at PS and advanced to be ready for this vaccine as well.

We obviously stepped tuned in Shingrix capacity recently, this is the CM technology platform. We got a double while many benefit by improving Shingrix we also got to step in our RSV capacity as well, which is great, which means that we are going to be ready for this launch as well..

All right. So the next question, please..

Thank you very much. Your next question on the line comes from the line of Seamus Fernandez from Guggenheim. You are live in the call. Please go ahead..

Great. Thanks so much for the questions. So I just wanted to go back to the gamma-secretase, just hoping you'd get to 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 2 expansions that you've started.

I'd 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 market. Thanks so much..

Yeah, Seamus. So I can be really quick on your second question and then hand back to how on BLENREP, but just to repeat what I've already said. We are very committed to the demerger of at least 80% of our holidaying.

We've had very positive levels of interest from our shareholders, and then we're looking at a timely and pragmatic monetization of the remaining 20% and we are on the runway and with really focused on exiting that brilliantly. Hal over to you on the various approaches to maximizing Mac..

Thanks, James. When you look at the strategy we have for maximizing the opportunity for blend rep in patients. It's important to remember that the risk benefit for myeloma patient changes according to a lot of therapy that we're we're studying.

So when we think about studying the second third outlying patients such as dream 3, we're going head-to-head with pomalidomide June 7th, and 8th, where we're going h ead 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 four-pronged approach of which gamma-secretase plays one role.

But we're really looking to see if we can lower the dose, as we've seen in the Algonquin study to doses like 1.9 migs per kig, where when we give it with standard of care therapies such as pomalidomide in other drugs that are approved. And we think that by lowering the dose, we might be able to reduce ocular toxic.

We also know that there is an opportunity and what we've seen 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 Q6 week or even Q8 week dosing regimen, where the peak trough (ph) ratio changes and exposure changes in a way that we -- 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 dream 2, we tend to hold the dose when patients develop, whether they are symptomatic or not.

A great three keratopathy, there's an opportunity to alter that holding pattern to say great to keratopathy, to prevent 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 off 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 four levers to reduce ocular toxin, 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 that can come in at meds, and most importantly, the line of therapy, we're mixing and matching those to optimize the program..

Thanks, Hal. Next question, please..

Thank you very much. Your next question comes from the line of Andrew Baum from city. You are live in the call, please go ahead..

Thank you. A couple of questions. Emma, has this thing very Caseli to your comments at the beginning of the call, and you described GSK is being agile in terms of COVID opportunities. One of your existing partners there, long-standing one has a novel non - paying stayed protease inhibitor for COVID.

I'm just intrigued if you've got 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 this thing to your answer to the question about private equity and the story that was on Bloomberg last week.

You have juxtaposed to your response about timely monetization of your stake. But the IPO or the sale of stock from GSK that you don't demerge potentially creates an overhang until it's put into the market. Are there potential creative solutions one may think about.

And I'm particularly thinking about, by which an overhang could be taken away and yet GSK could have access to capital early in order to facilitate business development. Thank you..

Yeah, well, Andrew, My reference to agility on COVID was frankly because it was less about, and I'm not going to comment on 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.

And 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 are approaching mRNA as Hal learnt earlier in terms of looking the proof of the platform within, COVID, because you can imagine a better global data than we have now. But I want to modify that no 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'll be fed say that they global level of supply around pandemic vaccines, even if such low percentages the developing world vaccinated so far is such a So I don't think that 's so much the primary question.

Although obviously we'll be thrilled to contribute not at least through COVAX as our pricing adjuvant readouts come and that we're dependent on our antigen partners in terms of their capacity to supply.

And on your other question, I mean, one 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 number one priority. We've said in a timely and pragmatic manner.

And we 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 will bring a lot more visibility to that in Q1..

Next question, please..

Thank you. Your next question comes from the line of Laura Sutcliffe from UBS. You are live in the call. Please go ahead..

Hello, thank you. Could you help us understand how Shingrix is working in the real world and 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.

Thanks..

Right, So Luke, an endeavor, please..

Sure. So Laura, great question. I mean, if you could someone presents seeking a COVID-19 vaccine, I think the key parameter is just the history of mentioned in the past. So if there's someone that regularly came for 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 COVID shot then the opportunity to discuss the benefits of being vaccinated for shingles is less.

In that case though, the retail pharmacists have incentives through the major change in the U.S to re-book that patient, to come back to the retail pharmacy on another day and receive that vaccination.

Or they can give those doses concomitantly, which I said has indicated their comfortable with, we're also running a study with Moderna COVID vaccine that will readout in Q1 of 22 just to build some more evidence around that co-administration.

And then the other train, which I think is just encouraging that I didn't mention earlier, is around seven out of ten, shots right now for Shingrix, either first shot and we now 90% of people so far come back for the second shot.

So it's their history of vaccination and how much time does that does the individual having the pharmacist had and then usually the aim is to rebook them to come back..

Helpful. That's great [Indiscernible] I currently feet fairly as having integrated inhibitors at the core, and they really are the premium goal 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 living with HIV, say, taking the second-generation integrase inhibitor. So our 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 integrase 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 integrated such as dolutegravir and bictegravir.

So this unique resistance profile, it's going to be very, very valuable. We believe the opportunity to really harness the OEP long-acting potential is to have it as a subcutaneous or intramuscular. And so what we would do is we now to 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..

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..

Thanks very much. Your last question on the line comes from the line of Kerry Holford from Berenberg. You are live in the call. Please go ahead..

Thank you very much. Two questions [Indiscernible].I think you said diagnosis [Indiscernible] in various amount 15 level of seeing any signs of improvement and how it is something you expect to normalized orienting meetings next, essentially, when do you expect to step change in his agenda sales group trajectory.

And then based on Benlysta those questions. any thoughts [Indiscernible] Phase three study failed to show any incremental benefit Benlysta mono. Thank you..

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

Hi, Kerry. Thanks for the question. I think the simplest answer is that Benlysta was not -- 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..

Right. Luke..

Thanks, Kerry. I think -- 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 IQV out of it, just showing that relationship. surgery did go up in August, we expect that posture restatement, but you can say obviously we hadn't got through the peak of Delta in the U.S.

in August. Hopefully as we go into the northern hemisphere winter, we see a reduction, and with the boost of reduction in the number of cases in more of these, women present to the GPS and then are diagnosed of course, are very difficult tumor tumor to diagnose because the symptoms are quite diffused. So that's the challenge.

The downstream effect then of course is typically they'll have 6 to 7 cycles of chemo. So upon 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 they relapse faster and therefore compress the total period of which they treated with the 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..

Thank you. In conclusion, it's a quarter where we've continued to deliver evidence that the hard work of the transformation program over the last four years is generating results. We've got strong business performance, double-digit sales growth in pharma and vaccines and increased momentum and Consumer Health, Matt the upgrade to full-year guidance.

And alongside the progress in strengthening pipeline reinforces our confidence in the outlook for step changing growth and performance from 2022 and beyond. And at the same time, we're very excited about the progress towards unlocking.

well, the shareholder value with the successful demerger in mid-2022, which is going to be a landmark year for our Company. Thanks very much, everyone. I look forward to following up with you in coming days..

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