GSK plc American Depositary Shares (Each representing two Ordinary Shares)

Good afternoon ladies and gentlemen and welcome to the analyst call on the GSK second quarter 2021 results. I will now hand you over to Ian McKay, CFO who will introduce today's

Good morning and good afternoon. Thank you for joining us for our second quarter 2021 results which were issued earlier today. You should have received our press release and view the presentation on GSK's website. For those who are not able to view the webcast, slides that accompany today's call are located on the investor section of the GSK website. Before we begin, please refer to slide two of our presentation for our cautionary statements. Our speakers today are Emma Walmsley, Luke Miles, Deborah Waterhouse, Dr. Hal Barron, Brian McNamara and myself Ian McKay. Joining us for the Q&A portion of the call will be Roger Connor and David Redfan. We request that you ask only a maximum of two questions so that everyone has a chance to participate. Our presentation will last for approximately 30 minutes in order to maximise the opportunity for questions and with that I'll hand the call over to Emma.

Thank you Ian and a very warm welcome to you all. We're pleased to report a strong financial performance and continued progress against our strategic priorities this quarter. Second quarter sales and adjusted EPS were up 15 and 71% respectively at CER. These excellent results were driven by a combination of strong double-digit growth in new and specialty pharma products, a significant increase in vaccine sales reflecting both an improving picture for vaccination rates and a major sales contribution for our pandemic adjuvant, good growth in consumer healthcare with double-digit growth in six of the nine power brands and discipline in control of costs. As expected the quarter did benefit from a favourable comparison to the second quarter last year which was heavily disrupted by the pandemic and while further disruption cannot be ruled out we are seeing positive momentum which we expect to continue through the second half of the year. Assuming a second half backdrop of improving demand for adult vaccinations and normalising health and consumer trends in key markets we believe we are likely to deliver adjusted EPS at the better end of our guidance. I just want to remind you that this guidance excludes any contribution from COVID-19 solutions which we expect to add between four and six percent to our adjusted EPS in 21. Alongside financial performance we continue to make good progress in R&D and our strategic delivery. Among our key assets we completed the filing of long-acting cabotegravip for prevention of HIV and we announced positive headline results for all five phase three studies of our promising specialty medicine Daproductat. Very importantly we also continue to strengthen the pipeline this quarter securing three exciting new collaborations in HIV, immuno-oncology and immunoneurology. And lastly this quarter also saw us lay out our new growth outlooks for GSK and the proposed de-merger of consumer healthcare. Delivering scale health impact and maximising value for shareholders are at the core of these plans and we've received widespread support from shareholders for them together with a clear message to focus on execution and successful delivery. We are all strongly committed to doing so. Progress for this quarter is reflected across all three 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. In performance improved commercial execution is driving strong growth in new and specialty pharma products. For Shingrix specifically we're clearly seeing the beginnings of a recovery and performance as COVID vaccination programmes amongst older populations near completion. The US new to brand prescriptions for Shingrix are up 73% in the quarter and we saw good performance across the consumer business with the exception of sustained weakness in cold and flu in a few specific areas where consumer trends haven't yet returned to normal. And on trust we continue to maintain leadership in ESG as evidenced by new index ratings. We recently signed as principal partner for COP26 and continue to progress our environmental commitments to be net zero and nature positive by 2030. As you heard of our investor update the scale of the changes we've made in the last four years is unprecedented. To improve performance, strengthen capabilities and prepare GSK for a new future. Our clear priority is to unlock the potential of two world-class businesses and in so doing maximise value for shareholders. With the platform we now have for GSK we expect to deliver highly competitive sales and operating profit growth in the next five years. A step change in expected performance and we aim to achieve sales of more than 33 billion pounds by 2031. All underpinned by an R&D focus on the power of the immune system, a portfolio shift to vaccines and specialty medicines to prevent and treat disease and impacting the lives of two and a half billion people over the next 10 years. And through the proposed e-merger we'll create a new category leading consumer healthcare business serving over a hundred markets with annual sales in 2020 of 10 billion pounds. Driven by brands and innovation to deliver better everyday health, this business has strong prospects for sustainable sales and profit growth, high cash generation and to deliver attractive returns for shareholders. So let me now hand over to the team to talk you through this course's performance in more detail. Luke, first over to you.

Thanks Emma. So we continue to make progress on commercial execution and competitiveness in the quarter against a complicated external environment due to COVID. The strong in-market performance are highlighted in the recent quarters for products such as Trilogy, Ucala and Benlista has continued driving growth of new and specialty pharma products of 25 percent in the second quarter and 14 percent in the half year. We also saw a good recovery in the quarter in meningitis and established vaccines. So today I want to focus my remarks on the performance and growth prospects for Shingrix and oncology. Excuse me. For Shingrix our confidence in recovery has been tied to the prioritization and successful rollout of COVID-19 mass vaccination, particularly in the U.S. Underlying trends illustrate that Shingrix volumes are expanding as we move into the second half of the year. Overall, despite the slower rate of recovery in -U.S. markets, we anticipate a strong half-two global performance from Shingrix with the potential for slight growth in sales on full-year basis. In the U.S. with nearly 80 percent of adults aged 50 plus now fully vaccinated for COVID, we've now seen a related increase in weekly NDRX volumes which have grown 73 percent since the start of quarter two. In the coming months it's going to be important for the recovery of Shingrix in the U.S. as our updated research shows that around half of those eligible to receive Shingrix have indicated that they expect to get it within one to three months following the completion of pandemic vaccine series. We've been implementing activities to drive this recovery with a comprehensive multi-channel DTC campaign and by focusing our maximum and relationships with U.S. retailers particularly as we focus on the flu vaccination season where adult vaccinations become increasingly top of mind for consumers. And we're starting to see similar trends in Germany where volumes are improving as more adults complete their COVID-19 vaccination series and in China we continue to make steady progress in the private pain market with Shingrix now in 50 cities. Overall though we're seeing a slower rate of Shingrix recovery -U.S. due to the differing rates of deployment of COVID vaccinations. Looking ahead we continue to roll out in new markets including the U.K. and we're now benefiting from an unconstrained supply position. Now this is going to support the expected significant step up in Shingrix sales in 2022. Assuming a continuation of the improved operating environment as well as our ambition to double revenues in the next five years protecting more than 100 million adults. If I now move to oncology, Zagula had a strong performance despite the impact of COVID on the ovarian cancer market. Sales were up 38% versus Q220 and we're pleased that in the U.S. we're significantly leading a new patient start with 59% of patients going to a part receiving Zagula. We're also seeing progress in U.S. patient awareness which has significantly increased from 29% in April 2020 to almost 50% in June 2021 and it decreased pleasingly in the watch and wait usage now at 57% although there are room for improvement. Unfortunately with the backdrop of COVID there's still a 20% decrease in ovarian cancer diagnosis and we know that with delayed diagnosis there are less patients getting debulking surgeries and therefore less patients going on to maintenance about six months later. So expect that this impact will continue until the market returns to pre-pandemic levels. For BlendRap we're seeing encouraging progress despite competitive entrance and we're especially pleased to see demand increasing with community oncologists in the U.S. and also Germany. We had a very robust clinical program designed to continue to improve the product profile of BlendRap through various combinations, optimized dosing and scheduling. On this slide we've outlined the patient opportunity and the associated clinical trials that align to earlier lines of treatment. The outcome of these trials will evolve our strategy including potential use of novel combinations and the substantial opportunity we see in second line where we have dose optimized pivotal trials. And with that I'll pass over to Deborah for an update on the HIV portfolio.

Thank you Luke. Second quarter HIV cells rebounded strongly, growing by 14% and more than reversing the 11% decline that we reported in Q1 due to COVID impacts and a strong 2020 comparator. Growth in the first half of the year was 1%. Strong commercial execution continues drive the performance of Davato particularly in the switch market in the U.S. and Europe. Davato and Jaluka are on track to deliver 1 billion pounds in sales this year. Our recently launched innovative medicines including Recobia now accounts for more than 25% of our total sales. A highlight this quarter was the market share of dollar Tegravir base regimens in Europe which for the first time exceeded 30% driven by Davato. Share continues to hold firm in the U.S. Turning to our portfolio of long-acting injectables, in January we received FDA approval for Cabinuvra, the world's first long-acting injectable treatment for HIV. It is also approved in Europe under the brand name of Bacabria recambis and dosing every two months. We anticipate approval of two monthly dosing in the U.S. by year end and launch in early 2022. Early signals are positive with strong brand recognition from people living with HIV and high levels of physician attendance at our virtual launch meetings which we believe will translate into increasing intent to prescribe. As with any new class of medicine, Cabinuvra will take time to build and furthermore the COVID backdrop is significantly constraining switch activity particularly where a patient needs to visit a physician's office. We're confident about potential to transform the HIV treatment paradigm and with an anticipated five-year head start over confessors we expect Cabinuvra to capture a leading share of a long-acting treatment market that could reach four to five billion pounds by 2030. This quarter we also made significant progress with Cabotegravir long-acting for prevention. We've completed the rolling submission with the FDA and anticipate launch in early 2022. If approved we believe Cabotegravir long-acting will present a new and compelling option in the prep market so every two months with efficacy that is superior to the current standard of care. As for the treatment market we believe the long-acting prep market could ultimately reach four to five billion pounds in value and Cabotegravir long-acting is poised to play a leading role. Last week at the international AIDS Society conference we presented week 48 data from the phase three salsa study which demonstrated that dovato is a compelling option irrespective of the type of threes regimen a patient may be switched from. We also presented the stat study which shows that dovato is acceptable for same-day tests and treats. For Cabinuvra we presented the customized data which not only shows that Cabinuvra is applicable in a range of healthcare settings but that 97 percent of people enrolled in the study preferred the long-acting injectable over daily oral therapy and in prep we presented more data from the pivotal HPTN084 women's study demonstrating that Cabotegravir long-acting is the first and only long-acting injectable for prep to demonstrate superior efficacy and comparable safety to daily oils in preventing HIV acquisition in a diverse population. Taken together I'm delighted with the progress we're making in HIV in both returning the franchise to growth and building our portfolio of innovative and pioneering long-acting medicines. I would like to turn the call next to Hal.

Thanks Deborah. I'm going to provide a short update on recent news flow since the June event and highlight some of the upcoming pipeline milestones over the next 18 months. Starting with Deborah Dustat. We recently announced positive headline results from each of the five trials in the ASCEND clinical program. As a reminder the ASCEND program recruited over 8,000 patients from both the dialysis and non-dialysis populations and was designed to demonstrate the safety and efficacy of Dipperstat as a novel oral treatment for patients with anemia due to chronic kidney disease. We're very pleased with the results from the ASCEND ND and ASCEND D studies which met the co-primary implants on both safety and efficacy. Dipperstat demonstrated an improvement in hemoglobin levels in untreated patients and maintained hemoglobin levels in patients previously treated with an erythropoietin stimulating agent, a standard treatment option in patients with anemia of chronic kidney disease. Importantly, the two cardiovascular outcome study, ASCEND ND and non-dialysis and ASCEND D for dialysis patients both demonstrated that DipperDustat was non-inferior when compared with erythropoietin stimulating agents in the risk of major adverse cardiac events or MACE. Additional analyses are ongoing and we aim to present these data at a medical conference later this year. Moving to business development. As I highlighted in June our strategy has been to leverage business development to augment our organic pipeline and we've made some recent progress on this with three deals which I'll cover briefly now. First is our global collaboration with Lector for two clinical stage first in class monoclonal antibodies targeting sordilin for neurodegenerative diseases. This collaboration brings together Lector's leading immunoneurology expertise with our focus on the science of the immune system and human genetics and proven late state drug development capabilities. The lead asset AL001 is currently recruiting a phase three trial for people with a progranulin gene mutation who have frontal temporal dementia or are at risk for developing FTD. Both antibodies AL001 and AL101 are designed to elevate progranulone levels by blocking the sordilin receptor. Progranulin is a key regulator of immune activity within the brain through modulating life's normal function. There are compelling genetic links to multiple neurodegenerative disorders including FTD, Parkinson's and Alzheimer's disease and these assets could offer a new approach to the treatment of patients with these considerable unmet need. Second is our collaboration with the IPOs for an anti-tidget monoclonal antibody in phase one development which I highlighted at our investor event in June. This deal complements our focus on the CD226 axis where we now have an anti-tidget and anti-CD96 and an anti-PD rig all of which can be combined with our P1 inhibitor, Jim Pearley. Preclinical data, human genetics and recent randomized clinical trial all highlight the benefit for modular immune CD226 axis which we believe could deliver transformational medicines for patients and usher in the next generation of biomedicines. Finally, the recent Halizime deal announced by Deborah and the VEEV team which offers the opportunity for ultra long acting regimens containing kebategravir and other VEEV pipeline assets. I also want to remind everyone that these three deals are not factored into the 2031 sales ambition we issued in June and would represent upside of successful. Lastly, this slide summarizes key data we expect to report over the next 18 months. As you can see we anticipate a large number of pivotal data readouts in 2022 as well as some important data points in the second half of 2021. Among our specialty products I've already spoken about the five positive phase three studies that produced that which we recently reported. We also have a number of data readouts and blend rep over the next 12 to 18 months including pivotal readouts looking to demonstrate a progression free survival benefit compared to standard of care for patients with multiple myeloma. Later this year we should have data from the proof of concept DREAM V sub study of low dose blend rep in combination with the gamma secretion for the treatment of patients with multiple myeloma. We are investigating a number of strategies to optimize the dosing schedule for blend rep and we hope that this sub study will maintain the efficacy of blend rep but at a lower dose which could reduce or delay the incidence of ocular events and support the potential use of blend rep in earlier lives of treatment. As I previously mentioned not only is this study important for advancing blend reps potential but it could also serve as a potential additional proof point for our functional genomic strategy. Other pivotal readouts on key assets in 2022 include otillumab in patients with rheumatoid arthritis plus data from several important vaccine candidates including RSV for older adults RSV maternal vaccine and data from our MENENG ABCWY pivotal studies. Finally we should receive a number of readouts from our COVID vaccines and therapeutics over the remainder of 2021 including pivotal data from our vaccines collaborations with medicago and tanofe and a phase two data from the oscar trial of otillumab and the comet peak study with cetropimab. With that let me hand it over to Brian.

Thanks Hal. Now turning to consumer health care in Q2. Continuing sales excluding brands divested and under review were strong up seven percent at constant exchange rates which included a two percent drag from retailer stocking last year ahead of the systems cut over in North America which reversed in the following quarter. Our Q2 results were supported by an easier comparator given de-stocking the same quarter last year following the pantry loading in Q1. The two-year kegger removed the distortion from the pandemic and was up three percent in Q2 which would have been up four percent excluding the impact of the unusually weak cold and flu season. Let me talk specifically about our category performance in the second quarter. In oral health sales increased 12 percent with a two-year kegger up five percent demonstrating good execution and successful innovations with sensitine and gum health more than offsetting lower growth in denture care. Pain release saw Q2 sales up 13 percent and delivered a good two-year kegger up five percent. In vitamins, minerals, and supplements sales declined six percent as we cycled the demand spike in the prior year although the two-year kegger was up six percent including partially good growth in centrum, emergency, and caltrade. Digestive health and other sales were up three percent in the quarter with a flat two-year kegger. Performance in this category was mixed with strong performance of smokers health products and digestive health brands but continued weakness in brands more dependent on impulse purchase such as chapstick. Respiratory sales increased 36 percent in the quarter and the two-year kegger was down three percent. This reflected very different results in the two subcategories with strong allergy performance and continued weakness in cold and flu. Don't forget that given seasonality Q2 is a smaller quarter for the cold and flu business. Our focus on innovation continued and we saw further positive momentum with sensitine sensitivity and gum as well as good performance from newer innovations such as Centrum Essentials in Brazil and Pronamel Intensive Enamel Repair Whitening in the U.S. In e-commerce we grew approximately 30 percent and this was seven percent of sales. Our ongoing investment in digital capabilities positions us well for growth and with continued strong results in the last month particularly in the U.S. we remain confident in our ability to outperform in this key channel. Turning to our power brands six of the nine brands gained or held share with six brands reporting double digit growth in Q2 and collectively power brands were up double digits. Additionally we saw a double digit growth in continuing business in emerging markets with particularly strong performance in India and China. Our full year sales outlook remains unchanged. Our separation and integration plans all remain firmly on track. The commercial integration is fully complete. Our manufacturing site cut over is well underway and separation activities progressing well into plan. Importantly all of our guidance for 2022 shared in 2018 including margin and synergies remain unchanged. Finally I'd like to take a minute to remind you of who we are and what we have created through the two largest consumer health care transactions in the last six years. As separation will be the first listed 100 percent focused consumer health care company as well as the global leader in consumer health care. Operating in a sector with compelling fundamentals and leadership positions and categories now more relevant than ever. We have a fantastic portfolio of brands and strong capabilities to drive sustainable market out performance and I'm excited to share more information with you on this incredible business as we move closer to separation. With that I'll hand it over to Ian.

Thanks Brian. As I cover the financials references to growth are a constant exchange rate unless stated otherwise. On slide 18 is a summary of the group's results for Q2 and a half year. In Q2 turnover was 8.1 billion pounds up 15 percent and adjusted operating profit was 2.2 billion pounds up 43 percent. Total earnings per share was 47.9p down 28 percent while adjusted earnings per share was 28.1p up 71 percent. In the year to date turnover was 15.5 billion pounds down 1 percent and adjusted operating profit was 4 billion pounds up 3 percent. Total earnings per share was 49.4p down 27 percent and adjusted earnings per share was 51p up 2 percent. We generated free cash flow of 313 million pounds in the year to date in line with our expectations. On currency there was a headwind of 9 percent on sales and 25 percent in adjusted EPS in particular due to the strengthening of sterling against the US dollar relative to the second quarter of 2020. Slide 19 summarizes the reconciliation of our total to adjusted results. The adjusting items of note for the quarter were in disposals significant legal and which reflected a 325 million pound tax credit due to a significant positive revaluation of deferred tax assets in the UK resulting from the Q2 enactment of the 2021 K finance bill. My comments from here onwards are an adjusted results unless stated otherwise. Key drivers of revenue and profits for the group in the second quarter compared to the prior year are set out in slide 20. Revenues grew 15 percent overall. Excluding revenues from our COVID solutions sales were up 11 percent. The pandemic adjuvant sales of 258 million pounds represent delivery around two-thirds of contracted volumes with US and Canadian governments. 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 partly offset by increased investment in R&D up six percent as expected and additional investment behind product launches with SG&A up five percent. The resulting Q2 margin was 26.7 percent and the -to-date margin was 26 percent. We expect R&D growth to be around 10 percent in the full year with the first half increase of five percent reflecting phasing particularly in 2020. Moving to the bottom half of the P&L I'd highlight that interest expense was 185 million pounds compared to 227 million pounds last year. The decreases primarily as a result of reduced interest expense from lower debt levels and favorable movements in foreign exchange. On share of associates in May we sold our stake in an Aviva which was the main contributor to income line. The effective tax rate of 18.4 percent was in line with expectations and reflects the timing of set and these tax authorities. And finally lower non-controlling interest reflected reduced allocation of consumer healthcare JV and Veev healthcare profits. Next I'll cover free cash flow for the quarter before going into more detail on performance drivers in each business. The first half of the year we generated 313 million pounds of free cash and improving cash flow performance continues to be a constant focus for the team. The significant step down in the year today was as expected and in line with our full year outlook. In the first half increased adjusted operating profit and lower dividends to non-controlling interests were more than offset by adverse timing of returns and rebates and taxes compared to the first half 2020. An increase in working capital adverse exchange impacts and increase of intangible assets as well as reduced proceeds from disposals of intangible assets with the consumer brands disposal program now complete. Turning to performance of the pharma business on the next slide. Overall revenues grew 12 percent driven by strong growth in new and specialty medicines, a prior year comparator that was impacted by de-stocking and favorable US return and rebate adjustments in the quarter. Impact of prior year de-stocking and the prior period RER adjustments including the impact of lower than expected Medicaid usage on a number of products accounted for approximately three and four percentage points of growth respectively. In the year to date revenues grew two percent and our full year outlook remains unchanged. The established pharma portfolio was flat within this established respiratory grew six percent while the rest of the established pharma portfolio stands seven percent. We still expect established pharma sales to decline high single digits in the full year. The pharma operating margin was 29.3 percent in Q2 and 29.1 percent for the first half. The increase in Q2 primarily reflected the positive operating leverage from the increased sales as well as continued tight cost control and restructuring benefits. RMD expense grew three percent in the quarter and year to date RMD spend also grew three percent which reflected phasing of spent particularly in 2020. We expect a higher growth rate in the quarter. Slide 24 gives you an overview of vaccines performance with overall sales growth of 49 percent excluding pandemic adjuvant revenue sales growth was 24 percent. In the year to date total vaccines revenues were flat and down nine percent excluding the pandemic adjuvant sales. In the quarter we saw improving pediatric and adolescent vaccination rates adult vaccination rates also improving continued to be affected by COVID-19 vaccination deployment. This resulted in Cindrick sales growing one percent while meningitis sales grew 46 percent established vaccines 28 percent. The operating margin was 32.7 percent the increase in operating profit and margin primarily reflected the positive operating leverage from sales growth including the pandemic adjuvant sales index. RMD spend increased 34 percent as we continued investment behind our RSV and meningitis development programs. Increased SG&A reflected investment to support the new growth. The year to date operating margin in vaccines was 29.3 percent. Recent trends in the U.S. indicating strong recovery of pediatric, adolescent and older adult vaccines are very encouraging. There remains however uncertainty as to impact of COVID-19 the speed of deployment of mass immunization programs and easing of pandemic conditions. This is notable in other key markets across the group such as Germany and China. The with these dynamics in mind and excluding pandemic adjuvant sales we expect vaccines revenues in the full year to be broadly flat. During slide 25 Q2 revenues in consumer health care increased seven percent excluding brands either divested or under review including those brands turnover grew three percent and Brian outlined the main drivers of this earlier. In the year to date revenues excluding brands either divested or under review decreased two percent. This reflected the continued negative effects of COVID-19 consumer behavior which has significantly impacted the cold and flu category and to a lesser extent denture care. The operating margin for Q2 was 21.7 percent up 50 basis points at CER versus last year and this included 110 basis points negative impact from divestments. The year to date operating margin was 22.4 percent. The strengthening of operating margins in Q2 has had a significant impact on operating margins. We remain on track to deliver mid to high 20s operating margins in 2022 at 2017 exchange rates. For consumer in the full year excluding brands divested under review we continue to expect low to mid single percent revenue growth. I close with considerations for 2021 outlook. We're maintaining our full year guidance for adjusted EPS to decline mid to high single digits. This excludes any contribution from COVID-19 solutions. Our strong Q2 performance gives us confidence that if we continue to see improvement in demand for adult vaccinations through the balance of the year as well as health care systems and consumer trends approaching normality in the second half of our key markets we're likely to deliver adjusted earnings for share towards the better end of our guidance range. However as the pandemic landscape evolves we continue to see global differentiation the pace of deployment of COVID-19 vaccination programs and the speed of economic recovery. As a result there remains potential for further pandemic disruption and we believe it's premature to change guidance. Specifically we're some one-off items in the comparative views which will adversely impact the next quarter. These include a blend rep recognition of pre-launch inventory and farm R&D of slightly more than 50 million pounds and a one-time benefit restructuring of post-retirement benefits of a similar magnitude which was primarily an SG&A. With these one-off items in mind we expect earnings growth in the second half to be weighted towards Q4. Turning specifically to contribution from COVID-19 solutions the positive impact on first half adjusted earnings per share was approximately seven percentage points. As mentioned earlier we fulfilled around two-thirds of contracted volumes for a pandemic adjuvant and expect that the full year contribution will be approximately four to six percentage points of adjusted EPS growth. The outcome within that range is dependent upon pandemic adjuvant contracting for 22 and the resulting potential charges within cost of goods sold as we continue to manufacture for this potential. As part of keeping you informed of our progress in executing against our strategy in the coming months we'll host businesses and pipeline information sessions covering among other topics growth drivers and HIV an updated outlook for DAPROTASAT and early next year we'll provide insights in our general medicines product area. We hope you'll be able to join us for these events. With that operator we're ready for Q&A.

Thank you everyone your question at the session will now begin. If you wish to ask a question please key star then one on your telephone. If you then decide to withdraw your question simply key status. Again to ask the question star then one on your telephone and the first question comes from the line of Andrew Barnett City.

Many thanks one question to Deborah and the second for Hal. So for Deborah the translocation inhibitor that you're about to take into the clinic for HIV you highlighted it as one of the long-term growth strategies. How confident are you in the freedom to operate on the intellectual property given I believe it's a pro-drug of Merck's is Latchavir which has a very extensive passenger state. The last time I looked I couldn't see much in terms of ongoing activity between you and the USPTO on securing a patent for your compound. So that's the first question. The second on Elector. Hal I understand the interest in progranulin from an FTD point of view but that's a relatively modest indication. So my question is how you've been thinking about selecting patients in the larger indications outside of Parkinson's given that some of the surrogate markers we've seen there are questionable significance in those indications. Many thanks.

Well thanks Andrew and I think you directed your questions very directly so Deborah why don't you kick off from the now.

Sure so Andrew as we talked about the business investor update we have a strong pipeline which is core and score has integrated inhibitors which we believe will form the heart of any two-drug regimen either oral or long-acting moving forward. We have a number of products in the pipeline of which we have an NRTTI but obviously we have others as well capsid, BNAB, maturation inhibitor etc. And our plan is to progress all of those medicines to the point at which we will make choices around which of them is the strongest moving forward. So that's all I want to say on where we are today with that pipeline. I think we talked about it in more detail at the BIIU but I guess for us our objective is to have maximum shots on goal and also with the help of our Halizime partnership to be able to deliver for people living with HIV longer and longer acting medicines.

Thank you for the question. You know it's a good question the genetics really give us extreme confidence I think in the FTD progranulin gene deficient patients and we have a number of diseases both from the sort of biology of non-progranulin FTD as well as potentially ALS. PD we know is a some disease from lots of genetic data and other sources and even Alzheimer's has been there's been some genetics suggesting that progranulin may be playing a role. So that's why we're excited of course neurodegeneration is a massive unmet medical need where the number of patients with these terrible diseases is growing and the treatment options are limited. So we're very excited about this. You point out that that in drug development for ALS to some extent more so for PD and a lot very clear in AD that the phase two surrogates haven't been as compelling as like them to be. I think there's a lot of opportunity using genetics to identify subgroups. We're exploring a lot of different markers of life-summonable function of immune activation. Imaging data can also help and other biomarkers like NFT and other sort of neural markers of degeneration are being explored and we're hoping to field advances over the next few years to enable some of those to be used for go no go criteria but I think to really be specific I think it's the massive medical need, the genetics and our confidence that with stratification variables and these biomarkers that are emerging we'll be able to make informed decisions when we progress these things through phase two.

Thanks Al, next question please. Thank you, the next question is from the line of Simon Maeder of Exams, please go ahead.

Afternoon everyone, thanks for the questions. I've got two as well, first one on the pipeline and secondly on the opportunities of COVID-19. Just on the pipeline on DAF ReduceStats, obviously a less than straightforward advisory committee meeting for Aster and Knox ReduceStat. Do you believe, I mean you can maybe comment if you believe you've got the right dosing to reduce the risk of any imbalance in the thromboembolism in your trials and does your, do the issues that AstraZeneca faced in their adcom in any way change your commercial plans given your lack of a renal franchise? And then just secondly on COVID-19 solutions and initially I wasn't really impressed that it was non-profit but clearly a strong contribution from the quarter, could you maybe help us understand the large opportunity you could have because obviously I think the last count Sanofi had signed up two billion doses for 2021-2022, so any help here with respect to the doses that that's in the 16 million relates to could potentially help us forecast the strong growth potential in 2022 and beyond, thank you.

Thanks Simon, well I think there's a lot of questions across the industry about the outlook the COVID market in 2022 and beyond but we'll come to Roger in a moment to comment on where we're at and how we see things evolving but you're obviously right that we also depend on our partner's supply even more than our own. Let's first come to Hal on DAFRA dosing and I think it'd be good Luke as well if you would like to make some comments on how you see plans forward and approach commercials too, but Hal first then Luke then Roger.

Yeah thanks for the question, I'm not going to comment too much on the ROCSA adcom but let me just say that we're very proud of the program we ran, it's a very robust program, had over 8,000 patients treated over up to almost four years, three and a quarter years in a variety of patients as you know dialysis, non-dialysis, incident dialysis, patient trials as well, we looked at quality of life etc etc. The study is really very robust but also because these were single trials where they were powered for in the AscendD and the AscendND for non-inferior to MACE and we've looked at the primary endpoint, we haven't looked at all the both on safety and efficacy but we haven't done all the subgroup analyses you want, you mentioned but we will be doing that later and hopefully presenting that at a major medical meeting ideally later this year. What I can't say is that the hemoglobin targets that we were pursuing as well as the interactions with regulators give us a fair amount of confidence that we've really designed what we think is a very large simple but robust program and gives us a clear understanding of both the safety and efficacy of the drug.

Alex?

Yeah I think from a commercial perspective, I hope the results that you're seeing today give you confidence in the evidence that we can commercialize a diverse set of specialty care products in what I think competitive segments. I think from a forecasting point of view it still remains quite dynamic, it's certainly radically different from what it was say 12 months ago in terms of our assumptions but yeah we're quite excited about this. In terms of COVID assets and commercialization, I mean Sanofi has the vaccines component but with TropeMab we saw just starting to deal with the European community for up to 220,000 doses. Just for clarity that's 16 countries within the EC are part of that framework and they have until between now and July 2022 to purchase that. Just before this call we had another contract come through from another government and then there's another attractive order that came through on Friday so we started to make progress there with TropeMab.

Roger would you like to talk about the vaccines?

Yeah certainly thanks for the question. I think on the adjuvant partnerships what we've seen this quarter are contracted volumes that we have in place between the UAS and Canada but they represent about two thirds of that overall expected demand for this year. I think it shows the strength of the adjuvant platform actually first of all we contracted separately on this and governments understand that the adjuvant isn't just for COVID-19, the adjuvant can be held and then used for future pandemics as well whether that be a flu or a further COVID place. There's optionality in this platform from a pandemic preparedness perspective. There's two variables I'd say that will determine sales going post-2021. Emma mentioned it, we have to be able to match this up with antigen demand or antigen supply going forward so whatever those volumes are will be a key variable and then secondly we're talking to governments now around pandemic preparedness and potential use of the adjuvant as well so those discussions could play out. So some uncertainties there's a difficult to say but there is certainly a lot of activity going on and I think governments are realizing the positive nature of a stock build of ASO3 in particular which some governments had in place before this pandemic as well and will this continue to update you as those discussions with governments conclude?

I think more medium term as well. I mean it is worth remembering the rather alarming statistics that only 13 percent of the world is currently doubly vaccinated and there is as you all know an ongoing debate around what the medium term profile is for a booster market or not and as you know beyond our current adjuvanted partnerships we're very involved in the MRNA platform too and so we'll continue to keep you updated on all of that but let me reiterate none of this is in either this year's guidance nor indeed in the outlooks that we shared with you in June. Next question please.

Thank you. The next question is from the line of Laura Sucliffe of UBS please go ahead. Hello

thank you. Firstly a more specific question on the size of the opportunity for GATPRO. I think you mentioned an unrisked adjusted peak sales range of half a billion pounds to a billion pounds back in June. Is that bookended by using dialysis and non-dialysis or are there some scenarios at this point where the peak sales could be greater than that billion pounds? And then could you maybe just give us your thoughts on combination opportunities for your older adult RSV vaccine? Thanks.

Yeah so let's come to Hal please and I think Laura Ian said during his remarks that we would bring you an updated review once we've got more published data but also on the outlook for GATPRO and just to refer you to what Lou just said you know the assumptions on the environment obviously shift according to competitors situations and you know still today unclear outcomes there as well as our own data which is across dialysis and non-dialysis. You'll get an update on that more later in the year but Hal do you want to I don't know if you want to add any further comments on either GATPRO but more specifically on combo possibilities for our exciting RSV pipeline?

Maybe I'm not totally understanding the question but is it combination meaning the adjuvant plus the perfusion is that Laura is that what you meant by combinations or do you mean multiple vaccines combined? I didn't quite understand the question. Maybe she's gone. I'll assume it's the combination meaning why we've decided to use an adjuvant plus the perfusion protein if that's what you think the question is. Go ahead. I think yeah I think Laura when we did the phase two study we looked at the perfusion protein alone and with various adjuvants and various doses and the summary of the data was a lot of complicated data but the bottom line I think is that when you look at the cell mediated immunity the pre-F specific CD4 positive cells you can see that in the elderly when you give the adjuvant the SO1 you can see a very nice bump in the CD4 immune cells which actually elevates to the level that's pretty close to what you see in young adults and we think that not only are is a robust B cell response which we we saw actually both with the unadjuvated and adjuvant component this T cell immune response we think is very important possibly for efficacy as well as duration and so that's why we decided to combine it with ASO1 the same adjuvant that's used with Shingrix which as you can see in the in the elderly is particularly effective then has long duration so that was why we went ahead as opposed to others with with an adjuvanted approach with the pre-fusion protein.

Thanks. Next question please.

Thank you the next question is from the line of Jo Walton of Credit Suisse.

Thank you I wonder if I could ask Luke a little bit more about his expectations for Shingrix in the second half of this year there's clearly very little progress in the ex-US sales overall in the first half of the year so can you tell us a little bit more about your confidence in the second half which additional countries you can go into how the pricing is forming in that in this in those new countries now that you are unconstrained in supply and can you just give us some idea of your assumptions on use of say a third dosage versus the ability to put your Shingrix vaccine in the other arm when someone goes to get a flu vaccine around September time and my second question would be again probably to Luke on the marketing side you were down 15 percent on your marketing spend in the first quarter up five percent in the second quarter given what we've learned about ability to do more digital etc going forwards can you give us some help as to what you think a reasonable rate of marketing growth should be over the next year or so thank you

so yeah yeah thanks so much so on the on the second one I mean it's interesting you know people were out of the field not spending or traveling if we look at -to-face activity now in Europe and the US with the exception of oncology which is a bit lower we're sort of 80 to 85 percent pre-covid levels if you add in -to-face digital the total activity is actually higher than that so you know in terms of expenditure we'll continue to allocate it to where we can drive the top line and where we see a good return so I think that you know the trends that you're seeing historical are probably a better indicator than quarter one and quarter two in terms of Shingrix you know it's it's really really interesting we track these as you can imagine you know very very closely and it's a consistent pattern where you see countries vigorously pursue adult vaccination it's highly disruptive to to to Shingrix vaccinations but the good thing is those patterns are consistent so Germany we're now seeing more than 80 percent of 60 plus year olds which is the population where it's reimbursed

are now

covered with COVID and we you know beginnings of a rebound in June in Germany of of Shingrix in China the emphasis is still on government vaccination centers deploying COVID vaccines so we continue to see that disruption in terms of other markets where we're also seeing that disruption so Hong Kong Australia for example where we've just launched they're obviously at the same point but we have other launches in in Spain and Italy and the UK in broader populations but also sub-populations in terms of pricing we've seen that level hold up now sometimes when we go into these markets we go in with an immunocompromised population first because we can get the most attractive price at that point and right now we can use all the volume in those settings so I think for the half we remain confident we'll see you know a collective response in in Shingrix in terms of boosters we don't assume the booster this year and it's interesting when you look at the market research in terms of people's intention for for vaccines you know we've covered the 50 percent on the slide but also if you ask them relative to other vaccines you know it's significantly higher than pneumonia and pertussis and other options for adults and second only to flu in terms of future intention to get a vaccine I think there may be some vaccine fatigue on the part of adults but again everything that we're seeing indicates that the second half will will be as expected

lastly Joe as well on COVID-19 I mean you know the guidance is that it is possible but as Luke said the experience would be that people there's a bit of sort of just human instinctive fatigue that people would rather leave it for a few months that we have the stats on that and we are running co-ad studies as well so you know that should equip us well fundamentally this is a disease that one in three people get we know the underlying demand is good and we're you know as Luke said we're being able to maintain economics and confident in the outlook that we laid out for the five years including with life cycle innovation which you also saw some recent announcements on in terms of some expansion of the cohort so

uh next question please thank you the next questions from the line of James Gordon of JP Morgan please go ahead

hello James Gordon JP Morgan thanks for taking the two questions uh first question was on the the um older adult rsv vaccine and competition so potentially the biggest product in the pipeline but I saw Pfizer just announced that in their um phase two challenge study they had 100% efficacy in adults and they also said they're going to kick off their phase three in September this year and they could report with early as q1 next year so my question is what does that mean for gsk's older adult program does the Pfizer data suggest their product could be at least as effective as yours or do we need to be careful trying to compare quite different end points and could you do the same thing could you accelerate your phase three and have data in the same sort of timelines or the reasons yours might take a bit longer and the second question was just a clarification on that for dusta so as i already mentioned your boxer had a tough adcom you know they had a non-inferiority headline on mace safety the point estimate looked worse than the assays and that didn't go very well at the adcom but it sounds like you're very very confident in your product so can you just confirm that's because yours looks differentiated from roxer i think your point estimate on mace safety does actually look better

how why don't you take both of those and roger if you want to add anything on the broader rsv perspective and come back to you

thanks thanks james um look i'm not going to make too many comments on the the announcement of phisor but let me let me just highlight a few things about what we know about our project and why we're so excited about it first of all just to anchor everyone of course rsv in older adults is an enormous unmet medical need with just in the united states alone over 180 000 people hospitalized and as many as 14 000 of those unfortunately die our our phase two as i was alluding to this earlier really does show pretty robust b cell response with neutralizing titers that are that are very comfortably in the range where we expect significant efficacy you know i'm personally very pleased that this data that the pre-fusion antigen is the right one as evidenced by our our data as well as now with the prizes so that's exciting it's also important to remember that our our program has this asl1 adjuvant which i i explained earlier provides this t cell immune response which we think will will actually increase efficacy like we saw with rsv but also maybe potentially duration etc so it's a differentiated uh vaccine combination if you will with the pre-f antigen as well as the uh very effective proprietary asl1 adjuvant i think it's also important if i understood it correctly that that um while we are very confident that the immune response will be mounted effectively in the 18 to 50 year olds this is again the older adults is is is you know an older population where again we need to be ensuring we have the most robust immune response to protect them as their immune systems are different and as i said earlier the the t cell immune response wasn't normal in an unadjuvanted rsv vaccine and that's why we chose to use the adjuvant because the t cell response became much closer actually almost identical to young adults in terms of the timelines and speed it's important to remember that as we said we're choosing this older adult population where where we think the the greatest medical need is and the timing of these studies are difficult to predict because first of all it has a lot to do with the size of your trial our study is very robust we're enrolling 25 000 patients whichever that we understand the safety and efficacy profile and potentially do subgroup analyses where of course the number of events determine how long the trial lasts of course the enrollment rate has a strong impact on that as the treatment effect of the drug so i can tell you that we're we're very confident that this is one of the most important projects in our pipeline and we're doing everything we can to excuse me expedited as fast as as we can and we're we're we're optimistic that we'll we'll complete this in a very timely manner so as far as uh that produced that um you know i'm not um again going to comment on the rocks adcom although what you stated um i think was pretty clear from the uh discussion

we

we don't have any data um from the essential also would be inappropriately for me like today just to comment directly on on um the the point estimate and confidence intervals i will say however that um the recent as you said the recent advisory committee meetings have disclosed i think pretty clearly that the fd wanted to see a non-inferiority margin of 1.25 i think that was pretty clear from the meeting and stated uh many times we have previously said that our design clinical studies um were were done with input from from regulators and agreement from regulators so um you know i don't want to say more than that but i'm very excited about the fact that we had five phase three studies that were positive and that this robust program really um was was um i think it's going to be a very robust package for the regulators to review

thank you how next question please

thank you the next question is from the line of kerry holford of berenberg please go ahead

thank you two questions please so firstly on the kervin antibody i wonder if you're willing to give as an idea um what would be the effective price per dose that you've secured for the dose orders you've um secured to date and over what time frame we should expect those orders to be delivered from booked um and then on the flu vaccine following the recent news you've begun to ship uh over 50 million doses in the u.s is it fair to conclude that the sale for flu vaccines this year should likely exceed 2020 figure which i think that's around 730 million pounds thank you thanks

gary well i'm going to ask only because i think he should have a question ian to talk about all the flu um uh outlooks and we'll come back to luke on the timing um uh i would say the short answer to are we going to give you precise pricing of our contracts will be no um but let's go to ian first and then come over to look don't

feel compelled to give me

so kerry

on a volume on a volume basis we would we would expect numbers to be broadly similar to last year however you'll recall from our commentary in the fourth quarter last year results which we did in early february that we had a very significant adjustment in flu last year and so net netting out that that rar adjustment which we clearly won't see the benefit of again i think volumes will be expected broadly similar but in dollar terms or sterling terms rather and will be slightly less

yeah and i would say that in the outlook of the four to six percent beyond guidance dps that includes the recent contracts it doesn't yeah it does so that's worth noting luke you mentioned it before is there anything else you want to add on the delivery yeah

yeah i think what we now need to do we've got this overarching contract we need to approach these 16 countries which include all of the major european countries and um sign up volumes uh and we've also got a number of other countries outside europe that we've got contracts for so i'm hoping in q3 we can give you a lot more granularity because have those in hand intensive pricing the only price that was given publicly is 2100 whack in the us where we're selling a small number commercially for europe you should just assume it's in the range of industry pricing

next question please thank you next question to the line of jacob porges of sbb layering please go ahead

thank you very much and a couple of questions for how our first just on the io portfolio you've highlighted the cd 2026 226 sorry portfolio many times i'm just wondering if you'd give us a sense of when we could see the first clinical proof of concept for your combinations the different combinations there for that whole strategy and then secondly on again the protostat do you believe that we should expect class labeling for the protostat for infection risk thrombosis risk and seizure risk given the imbalances seen in your competitors trials as you know the fda has been extraordinarily cautious about labeling in the ckd population for the esas and so would that be prudent on our part thanks

thanks jeff yeah thanks jeff um you know the io portfolio is is actually quite robust now and the cd 226 axis i think is well covered with both the now anti-tidget from itos we have the cd96 inhibitor is most advanced in our collaboration with 23andme and the furthest behind but but also exciting is the anti-pv rig which should get into the clinic next year was a deal with surface oncology recently all of those of course can be combined with each other as well as with the the four drug combos are quite complicated and there'll be a lot of dose ranging that's needed indication ranging if you will and we will be getting data from combinations with c96 and to start on that first so that will be the first readout that should occur in 2022 we should be able to get some pv rig data probably in 2022 as well the digit combinations with the starland we'll be seeing in 2022 hopefully some data it all of course depends on how robust the data is and what the whether we see activity at various doses the triplet will take a little longer just because we have to get through all the dose ranging and safety but that should come you know following the observation of of proof of concepts with those combinations so exciting opportunity we think to take the field beyond the pv1 era and enter into a cd226 era possibly a doublet or maybe even a triplet if if if the cards fall appropriately we can make a triplet that would be profoundly beneficial for patients if that was the case so excited about that opportunity in terms of dapple i really don't want to comment on discussions that we haven't yet even started with regulators the data that i mentioned that we are very excited by was the primary endpoint we haven't done any of the subgroup analyses and other sensitivity analyses that are going to be of course needed we'll be doing those very soon we should have that data and hopefully be able to present that later this year of course then that's followed by discussions with regulators digestion of the of the class as you say and and i think it would be premature to to have any speculation on what anyone else's labels might show for sure and ours will of course follow the data thanks for the question jeff

thanks our next question please

thank you next question is from the line of kaye perec of goldman sachs please go ahead

good afternoon two questions please um one on commercial opportunity for blend rep luke i noticed that bristol kind of reported first quarter revenues for the bcma carti or 24 million dollars that's roughly similar to the 21 million sterling you reported for blend rep so just give us a sense for where kind of bristol's taking share and how confident you are for growth of blend rep even without the additional studies kind of reading out and then separately for brian brian congratulations on kind of the CEO designate not surprising that at all but your slide talks about e-commerce being seven percent of sales for the consumer health care business up 30 for the quarter just wondering if you can kind of give us a sense for how the seven percent tax relative to your peer group what was the corresponding number last year so just give us a sense for how big you think e-commerce might be for the glaxo consumer health business going forward thank you

thanks okay so luther yeah

sure so i mean i think okay i'll just lay this out i mean it's right now we have about a quarter of patients in the u.s who are fifth line in terms of of patients on drugs but about a third of them are now um about a quarter of fifth line but the rest are you know six seventh line but one three new patients coming on a fifth line so we're starting to move up there you know i think there has been a bit of pressure in that fourth line setting it's a relatively small number of patients there's a lot of competition for them with studies such as the custom ad the the bi specifics in terms of the car t i mean let's see there's some ordering patterns probably there again it's concentrated in academic centers where we're now seeing our growth is in the community which is a natural progression i mean in the end though we need to we need to address the dosing and as hallows outline there's a lot of activities to do that to to penetrate the the earlier lines of treatment where you know the vast majority of the opportunities for this product exists we're less concerned around the tax though you know again i think that is being used in in the emd population and some of the the talks around heme and it's impacting treatment length so i think we've we've got more work to do to capture those fourth line patients in the community and we're working very hard to do it

thank you brian digital

yes for the question and thanks for congratulations also as you said our our e-commerce's percent of sales is seven percent up 30 last year we were at six percent of sales we continue to see progression as far as how that compares to competitors it really is dependent on quite dependent on portfolio if you look across our portfolio it's an oral care we are overdeveloped where we have higher shares in many of our brands online versus offline in otc we're pretty much in line but towards again being overdeveloped so slightly better than i would say the competitive set and on vms actually is an area we're catching up so we were underdeveloped on vms as there's many more digital native brands in that space but we're growing in that area very aggressively and we're seeing really good progression in that area so you know i continue to believe this is an area that's going to continue to grow really healthy we've seen a massive shift in these categories to online shopping as part of the behavior that came with the pandemic and we see that consumer that behavior continue continuing and i feel really great about where we're at and and our capabilities in this area to continue to win in the space

thanks brian and i would also like to add my very public congratulations and pride in your and your appointment thank you i'm glad

you got a question along the other

thing i would just overlay is it's not only the brand power digital it's also the geographic mix where because of our strong presence and consumer in both the us and china which are very e-commerce friendly regions that also helps drive both our capability and competitiveness on that next question please

thank you the next questions from the line of emmanuel papadakis of virtue bank please go ahead hi mary

hey thank you so better get you first question on margin please you reiterate the mid-high 20s for next year i think um but obviously that's as part of the current business not as a standalone i know there's been some discussion of what additional standalone costs you would incur so any insight you can offer us at this stage in terms of um the step down on margins we'd like to see it as a standalone business and if not now even if in quality if not now when are we likely to get that number and then maybe a question on the r&d side you reported a missed moonstone perhaps you could give us some comments on the data unit that missed the the target you're after on our what does that imply if anything to come up with a program for the jula i don't actually think we'd any pivot or proof of concept base points for the rest of this year or even next are we just waiting for that zeal lung maintenance by the end 2024 or the other things we should be thinking about looking out for what you're considering thank you

uh thanks very much we'll come in a moment to how but first of all brian do you want to comment on when it will be shared

yeah as emma mentioned we'll be doing a capital markets day in the first half of next year we haven't uh identified that date yet but at that time is when we would share much more detail around the business um in a lot of areas around you know our cash flow and our um our margin uh progression and included in that would be any of the one-off costs so you'd expect to hear about that next year before um before separation thank you

al minster an implication yeah i mean could you

just i part of manuals question dropped out could you just repeat it um briefly

i can repeat it if you can hear me oh thanks you're welcome so it was just a question on the myth in moonstone what it implies for the clinical development and next data points we should be looking forward to thinking about

thank

you that's what i

thought you said just want to confirm your correct moon's been stopped i think it's important to point out moonstone was a single arm open label phase two study where we were looking at response rate it was in the most patients with ovarian cancer to treat the so-called platinum resistant ovarian cancer patient populations who actually do not very well even with chemo and bevacizumab but these are second line those who failed bevacizumab so very resistant population but was based on some very small numbers of patients that suggested maybe the combination of of a pv1 plus parp would be would be beneficial so we had a very high bar and the the study where we looked at the response rates didn't suggest that it was going to achieve the bar we had now the study that we're always been more optimistic about because again moonstone was in the treatment setting where frankly parts the data for parts in the treatment setting has been in terms of efficacy in the maintenance setting is where you really see the benefit and the study that we thought would most definitively identify an opportunity for the combination of a part plus p1 was the so-called first clinical the first trial which is in as where patients were received chemo with the staromab and niraparib versus standard of care platinum-based regimen and that um is enrolling well and we should see data for that before the next opportunity to have a direct read through for this synergistic potential synergistic impact we're also as you as you mentioned committed to other combinations of niraparib with the staromab we have the phase three ruby part two section where we're comparing the staromab in combination with niraparib for patients with endometrial cancer and of course we have the test and zeal both of which could be transformational for patients zeal being in the front line lung cancer setting and that's being a novel a novel study designed for patients who are surgically breast women with breast cancer who are surgically treated for the intent of cure but who's who have evidence through tumor measurements in the blood the cell-free dna from the tumor being evident as a biomarker that we're using to start treating people to potentially prevent the disease from recurring so two innovative and i think exciting trials that in addition to first will will add hopefully a lot to patient benefit into the life cycles

niraparib thanks hal

we could time for one more question and then we'll

okay have

to wrap it up if that is one more question

thank you the next question is from the line of graham parry of b of a please go ahead

great thanks for any questions so just firstly on shingrix i'm just wondering if you could just help us kind of square the circle of the different commentary so that the guidance is a little cautious but you're still talking confidence in strong recovery in two h so i i used to expecting a very strong 2022 i think consensus is looking for 25 percent -on-year growth so does that sit within the range of your outcomes internally and then secondly just following up on the question on phisers rsv vaccine timing that suggests perhaps they might be expecting more rsv events coming this season if they think they can get a data readout in q1 so is it also the case that perhaps the rsv incidence is picking up relative to what you assumed when you originally planned your studies meaning your data could also come earlier thank you

so how we will come back again to the rsv study and just on on on shingrix yes we do see a significant set up in 2020 we're not going to start commenting on versus specific and some guidance on on that one one grain but how would you like to comment on on the rsv study yeah just

to reiterate you know we there's a lot of assumptions that go into determining how long the trial will take of course as i mentioned before it has a lot to do with sample size so we are are enrolling 25 000 people that enrollments going very well it does have a lot to do with the number of events which is actually related to some extent to the treatment effect and there is you know some reason to believe that the events might be higher than anticipated based on the fact that in 2020 there was very limited rsv and sometimes there's you know without the the prior season immunity sometimes there's more clinically significant cases but again we're all estimating these things and it would be probably more like a class effect if you will that if there's more events it's going to we'll be seeing that in any trials and rsv will be obviously unique to us or Pfizer or anybody else so we we just have to wait and see and of course anything's possible but the idea that maybe there's more rsv because of the 2020 low levels there there is some data suggest that might be the case we'll just have to wait and see

thank you very much and with that we'll finish today's call and look forward to catching up with you in the in the coming days for those that we don't get to speak to i hope whether it's near or far you get some kind of break and look forward to catching up again soon all right thank you goodbye