Good morning and good afternoon. Thank you for joining us for our Q2 2020 results, which were issued earlier today. You should have received our press release and can view the presentation on GSK's website. For those not able to view the webcast slides that accompany today's call are located on the Investors section of our website. Before we begin, please refer to slide 2 of our presentation for our cautionary statements.
Our speakers today are Chief Executive Officer, Emma Walmsley Ian MacKay, Chief Financial Officer and Doctor. Hal Barron, Chief Scientific Officer. We have a broader team available for Q and A. We request that you ask only a maximum of 2 questions so that everyone has a chance to participate. And with that, I will hand the call over to Emma.
Thank you, Seth, and welcome everybody to today's call. I hope that you and those around you continue to be well. At this half year mark and in what have been extraordinary circumstances, I am pleased to report that we've mobilized across GSK to respond to the pandemic and have simultaneously advanced our long term strategic goals at pace. Adjusting rapidly to the new ways of working, we secured supply, strengthened the pipeline, progressed multiple solutions to the pandemic and our integration and separation programs are all firmly on track. While we have seen some COVID disruption impact our performance this quarter, we're pleased with half year delivery and our confidence in our business and its prospects remains high.
Hal will give you an update on our innovation progress shortly, but particular highlights in the last few months include in oncology, the U. S. Approval for Zejula as a first line monotherapy maintenance treatment for women with ovarian cancer. We were also pleased to see positive opinions from the FDA's ODAC and CHMMP on belantamab mafedotin, a medicine we believe will be very important for multiple myeloma patients. In infectious diseases, we made great progress in HIV with the presentation of truly groundbreaking data for long acting cabotegravir in the prep setting.
And in vaccines, we're poised to move into pivotal studies for very significant opportunities in RSV and meningitis and have
just announced
our collaboration with CureVac targeting up to 5 infectious disease pathogens. Despite short term pressures, our performance fundamentals continue to strengthen with good momentum and strengthening commercial execution on our key growth drivers. We're winning share in respiratory in oncology with Tejula with 2 drug regimens in HIV and in power brands and consumer, including a notable acceleration in VMS demand. We've seen strong acceleration of our digital capabilities as we've continued to increase our share of voice with HDPs, both virtually and face to face where possible, as well as winning share in an accelerating e commerce channel in consumer. Our consumer integration and company separation programs both continue to progress well and undistracted with over 90% of Pfizer revenues now successfully remotely switched over to GSK system.
And Ian will update you on this and broader cost discipline later. And we continue to progress our consumer divestments, including Horlicks, to set up the world's leading pure play consumer healthcare company with the most competitive portfolio possible. On Trust, alongside others, we helped launch a $1,000,000,000 AMR Action Fund to fight another major risk to global health. We were delighted to receive U. S.
Approval for formulation of dolutegravir. And finally, I was very pleased to see all time record levels of employee engagement in the quarter, driven by pride in GSK's purpose, our people's sense of being valued and the positive cultural changes we're making. We've taken a comprehensive approach to respond to COVID-nineteen using our science and technologies to develop adjuvanted vaccines and therapeutic solutions, while at the same time accelerating momentum on existing R and D projects and investing in our future capabilities and competitive advantage. We at GSK firmly believe multiple vaccines will be needed to fight COVID and it's why we've deliberately taken a unique collaborative approach with a proven technology to develop adjuvanted vaccines. GSK's adjuvant is proven in a pandemic situation and alongside improved efficacy, it can help reduce the amount of antigen needed and get to scale faster.
We can deliver more than 1,000,000,000 doses of adjuvant in 2021. We announced an agreement to supply the U. K. This morning and we're in late stage discussions with multiple other governments taking a global and access led approach. We're also making good progress to start clinical development of promising therapeutic antibody options, which could be in market next year.
We've moved to accelerate our access to new technology platforms through strategic collaborations that will advance our R and D in multiple disease areas and could be relevant in future pandemics. And we've continued to accelerate momentum with existing projects, which remains important, while so much attention is focused on COVID. Of course, as we COVID has disrupted our performance this quarter. Pro form a group sales declined 10% in CER terms with the greatest impact of the pandemic seen in our vaccines business as access to vaccinations was limited. We also saw some of the patient and consumer stock build in Q1 reverse as expected.
Group adjusted operating margin for the quarter was 22.9%, particularly the performance in vaccines, together with increased investments in our pipeline and new products, partly offset by ongoing tight cost control. On a total basis, earnings per share were up over 100 percent to 45.5p and adjusted earnings per share decreased 38% to 19.2p. For the first half overall, sales were up 8% reported and flat on a pro form a basis with continued progress on our performance in pharma and consumer and despite the significant but short term impact we saw from the pandemic and vaccines. Adjusted operating profits were down 7% pro form a as we continue to invest behind advancing our pipeline and new product launches. And the momentum here is encouraging in our key growth drivers.
In vaccines, despite lockdown impact on vaccination rates, we believe the underlying demand for our key vaccines, including shingles and meningitis, remains very strong. Guidance from government agencies, including the CDC, is emphasizing the importance of routine immunizations and catch up for all age groups, including adults. We're seeing encouraging signs of recovery in selected geographies in Q3 and are investing to support it, though there remains some way to go to get back pre COVID levels for adult vaccinations such as Shingrix. We expect to see vaccination rates recover in the second half of the year. We're confident it will come, but clearly there remains a degree of risk on the exact timing.
We continue to work on expanding capacity for Shingrix to support recovery and demand and to enable further launches around the world for this important and much needed vaccine. Sales in our respiratory portfolio are performing strongly. With Trelegy, we continue to lead the market as a single inhaler triple therapy and also grow the market with sales up 58% in Q2. We're looking forward to the FDA's decision too on the asthma indication for TRELEGY later this year. And for Nucala, we continue to see strong growth aided by strong uptake of at home administration.
We're retaining leadership in all key markets and expanding our label in other asynophilic indications, which will further cement our leadership. In oncology, we've built a strong commercial platform from which to grow Zejula and also launch belantamab on approval. For Zejula in the U. S, the latest flat iron data, which was for May, already indicated a 50% increase in Zejula share in first line maintenance to 21%. Although with the pandemic, we've seen delays in initiation of chemotherapy and debulking surgery in recent months, which does add a near term headwind, we remain confident in the long term outlook for Zejula and there is a lot of opportunity with new guidelines and currently low levels of part penetration in first line maintenance.
Continue to believe Zejula is an important medicine with potentially unique properties. In HIV, as expected, we've seen the unwind of Q1 pull forward. And whilst the pandemic has reduced switching a new diagnosis, we nonetheless continue to see increases in Dovato and Juluca NBRx share to 9% this week in the U. S. And are optimistic 2 drug regimens growth will accelerate when the situation normalizes.
We also expect Dovato to benefit from a broader U. S. Label later this quarter with the anticipated inclusion of data from the TANGO study. We continue to make great progress on innovation in HIV and Hal will give more detail on this in a moment. I'm now going to hand over to Iain, who will take you through our financial performance and outlook.
Thanks, Emma. All the comments
I'll make today will be currency basis except for I specify otherwise, and I'll cover both total and adjusted results. On Slide 10 is a summary of the group's results for Q2 and the half year. In the first half, turnover was up 8% on a reported basis and flat on a pro form a basis. Excluding the impact of disposals, revenues were up 1%. Adjusted operating profit was up 2% reported and down 7% pro form a.
Adjusted earnings per share was 56.9p down 6%. For Q2, turnover declined 3% on a reported basis and 10% on a pro form a basis. Excluding the impact of disposals, revenues were down 8%. As you've heard from Emma, we continue to see strong underlying performance of the business. However, during Q2, we saw turnover adversely impacted by the COVID-nineteen pandemic with the most significant impact within vaccines.
I'll go into the business drivers in a moment. Total operating profit was up 90% with total EPS up over 100%, primarily reflecting the net profit on the disposal of Horlicks and Consumer Healthcare brands. On an adjusted basis, operating profit was down 21% reported and 27 percent pro form a, while adjusted EPS was down 38%. Earnings were impacted by lower turnover, continued investments in R and D, support of new product launches and increased effective tax rates and a higher non controlling interest allocation of Care Profits. These were partially offset by continued tight control of operating costs across the business.
We delivered GBP 2,500,000,000 of free cash flow in the first half, reflecting favorable working capital, timing of RAR payments
and proceeds from divestments of
intangible assets. And in currency, in the quarter, And on currency, in the quarter, there was a 1% tailwind on both sales and adjusted earnings per share. Slide 11 summarizes the reconciliation of our total to adjusted results. The main adjusting items in the quarter were major restructuring, which reflects continued progress in the Consumer Healthcare integration and separation preparation programs. Transaction related, within which the main contributor was a charge relating to re measurement of the contingent consideration relating to Beeb Healthcare.
And finally, the disposals column includes the disposal in the quarter
of Horlicks and other
consumer healthcare brands. My comments from here onwards are an adjusted result unless stated otherwise. Slide 12 summarizes the Pharmaceuticals business where revenues were down 5% in Q2, primarily resulting from the decline in established pharma. As expected, the COVID-nineteen related customer stock building in Q1 predominantly in Europe and the U. S.
Broadly reversed in Q2 with only a minor dollar takeover impact Europe and the U. S. Remaining. We estimate that the impact of the stocking reversal in growth in Q2 was approximately 4%. The quarter also saw lower levels of new patient prescriptions in the U.
S. And Europe, reduced market demand for allergy and antibiotics products in international and some pressure on net prices in the U. S. Informed by a shift in channel mix. For the 1st 6 months, pharma revenues were flat CER and adjusted operating margin was 25.4 percent CER.
And I've just taken you through
the performance of some of our key products. I will just point out a couple of important considerations with respect
to the
Q2. Starting with respiratory, sales were up 16% with strong growth from Trelegy and Nucala. In oncology, Zejula sales were at GBP77,000,000 in the quarter, up 32%. In HIV, revenues were down 3% with the Dolutegravir franchise down 2% globally. Sales were impacted in the quarter by customer destocking following the increased demand in Q1 due to COVID-nineteen.
We continue to see good uptake of the 2 drug regimens, however, giving us confidence in the longer term growth outlook. Excluding the impact of customer stocking, we estimate that HIV sales would have increased slightly in the quarter and we expect sales to be broadly flat for the full year. Our established pharmaceuticals portfolio declined 17% overall impacted by Ventolin, which was down 39% as a result of generic substitution in the albuterol market as well as pandemic related destocking in Europe. Seretide adverse sales were up 2% with the U. S.
Up 34%, reflecting higher demand in the ICSLABA class, offset by declines in Europe as a result of generic competition and pandemic related destocking. Outside respiratory, established pharma portfolio declined by 20%, primarily reflecting lower demand for our dermatology products and antibiotics during the pandemic. Overall in pharma, trends remain encouraging and our new products continue to perform well. We continue to expect pharma sales to decline slightly in 2020 excluding divestments. Turning to the pharma operating margin.
As anticipated, we saw a decline in Q2, primarily reflecting sales performance, while we continue to invest in R and D behind priority assets and promotional activity for new launches. We have maintained a sharp focus on cost management across the business with focus on increased efficiency in non customer facing activities and more on this subject later. Slide 13 gives you an overview of Vaccine's performance with sales down 29%. As expected, Q2 revenues were impacted by containment measures informing customers' ability and willingness to access immunization services across all regions. Shingrix declined 19% globally, primarily reflecting lower vaccination rates in the U.
S, which was partially offset by favorable return in rebate movements. The meningitis portfolio declined 29% impacted by lower demand across all regions. In the U. S, Baxdero maintained and Minveo grew market share. Hepatitis vaccines declined 62%, primarily reflecting travel restrictions.
And HVA containing vaccines declined 43% and we'll have a similar drag on vaccine sales growth this year. The operating margin of 23.4% reflected the impact of reduced Q1. In the first half, Vaccines revenue was down 6% CER and adjusted operating margin was 38.2% CER. Turning to Slide 14, revenues in consumer healthcare on a pro form a basis were flat excluding brands either divested or under review, reflecting the unwind of increased COVID-nineteen demand we saw in Q1. Including those brands, turnover declined 6% pro form a.
At a regional level, China returned to growth as mandated retailer shutdowns were lifted. However, this was more than offset by declines in Europe and the U. S. As a result of the pantry loading unwind. The vitamins, minerals and supplements category continued to grow strongly with sales growth in the high teens on a pro form a basis.
This hard demand reflecting an increased customer focus on health and wellness. In pain relief, sales benefited from the continued strong performance of Pandell and the successful Rx to OTC switch and launch of Voltarin OTC in the U. S. This was offset by an adverse impact on Advil due to initial market misinformation relating to COVID-nineteen Ibuprofen treatment, which has since been corrected. We're also excited about the launch of Advil Dual Action.
Sales also benefited from the increased retailer stocking ahead of a systems cut over in North America as part of Pfizer integration activities, which added 2 percentage points of growth in the quarter, largely in the digestive health and pain relief categories. This benefit is expected to reverse in Q3. We're close to fulfilling our commitment to divest $1,000,000,000 of non core brands in order to refocus our portfolio as well as funding integration and restructuring activities within Consumer Healthcare. Operating margin for the quarter was down 120 basis points year on year. In the 1st 6 months, consumer revenues increased 2% CER pro form a and 7% excluding the impact of divested and brands under review.
Pro form a adjusted operating margin was 24.5%. With the integration on track, we're delivering synergies as anticipated and continue to maintain strong cost control while investing behind our brands. On Slide 15, we summarize the sales and adjusted operating margin for Q2. As I mentioned, our group operating margin was down 5.30 basis points on a pro form a basis and is informed primarily by the sales form a basis reflecting integration savings and reduced promotional and variable spending across all three businesses as a result of this pandemic. This is partially offset by targeted investment in customer facing activities focused on growing the top line.
We continue to maintain a sharp focus on cost management and are on track to deliver, firstly, synergies from the consumer integration, achieving £500,000,000 savings between now and 2022. Secondly, benefits from the separation preparation program across multiple activities, including the supply chain, development in R and D, commercial operations and our global support functions resulting in efficiencies which will deliver GBP800 1,000,000 of savings by 2023 and will contribute to meaningful margin expansion from 2022 onwards. And thirdly, savings from learnings over the past 4 months with opportunities initially across travel and entertainment, concerts and meetings, commercial real estate and through finding new ways of engaging with our customers, healthcare professionals and our other stakeholders. We've included in the appendix this analysis covering the year to date information. Moving to the bottom half of the P and L, I would highlight that interest expense was GBP 227,000,000 The increase primarily reflects reduced swap interest income and foreign currency hedges and lower interest income and reduced overseas cash post the close of the divestment of Horlicks and other consumer healthcare nutrition products in India.
This was partly offset by favorable refinancing of term debt. The effective tax rate of 20.5% reflected delays in the settlement working periods and updated forecast profit mix for the year. We now expect full year effective tax rate of around 16%. And non controlling interest reflected Pfizer's share of profits over the consumer healthcare JV. We delivered cash flow of £2,500,000,000 in the first half of the year.
The increase primarily reflected a reduction in trade receivables a result of collections following strong sales in Q1, beneficial timings of payments for returns and taxes, a lower seasonal increase of inventory and disposals of intangible assets. These were partly offset by higher dividends to non controlling interests. Recognizing the lower Q2 revenues and the H1 impact on timing of RER and tax payments, we anticipate lower free cash flow in the second half. Overall, we still expect cash flow to be a step down from 2019. As well as the positive cash flow we delivered in H1, closed the quarter with strong cash balances, have an effective approach to working capital management and maintain access to extensive undrawn committed facilities.
Turning now to our outlook and guidance for this year. We're maintaining our full year guidance of adjusted EPS down 1% to 4 percent. Our performance for Pharma and Consumer in the first half of the year is in line with where we expect it to be. We expect limited impact from COVID-nineteen related stocking patterns for the balance of the year in these two businesses. However, there remained notable risks to business performance over the balance of the year, primarily in vaccines.
As evidenced in the Q2, the pandemic's biggest impact has been here. The key variable in achieving adjusted EPS guidance in the full year is the timing of the recovery of vaccination rates. Underlying demand for our vaccines portfolio remains strong and we put in place a range of actions to support the recovery of vaccination rates, which we anticipate and are seeing take place so far in the Q3. Should we experience a delay in recovery of vaccination rates of say 3 months for example, this would adversely impact full year adjusted EPS by up to 5 percentage points. As we move into the second half of twenty twenty, there's no change in our capital allocation priorities.
These are investing in R and D behind priority pipeline assets and delivering returns to shareholders. And as noted in our earnings release, we've declared a 19p quarterly dividend in line with expectations we set out earlier this year. And with that, I'll hand over to Hal.
Thank you, Ian, and good afternoon, everyone. It's been 2 years since I shared our new approach to R and D, and I'm very pleased with the progress we are making. Today, I will review this progress and then discuss several very exciting medicines and vaccines in our pipeline. And with that, I'll begin my presentation. Let me start with a brief reminder of our approach to R and D, which I outlined in 2018.
That is to strengthen our pipeline through a focus on the science related to the immune system and to use human genetics and advanced technologies such as functional genomics and machine learning to enable us to identify novel targets that have a higher probability for success and a robust lifecycle potential. To achieve this, we have focused on 4 key strategic levers. 1st, to drive organic growth by focusing our research organization on human genetics and on both the adaptive and innate immune system. In development, we have removed numerous projects from the portfolio to enable us to design and execute robust clinical trials on the more promising programs. 2nd, to effectively leverage business development to augment our pipeline.
3rd, to improve how commercial and R and D work together to maximize the lifecycle of our medicines and vaccines. And lastly, to shift our culture in R and D to one that embraces innovation by focusing on smart risk taking, single point accountable decision making and hiring and developing outstanding people. I believe we have made significant progress over the past 2 years. Over 70% of the targets in research are now genetically validated with nearly 30 therapeutic targets originating from the 23andme collaboration. We have exceeded industry averages for success in proof of concept studies, enabling us to initiate 9 potentially registrational studies.
In addition, we've had 17 positive results from pivotal studies. Lastly, we are on track to achieve 14 approvals since July 2018 with potentially 5 new molecular entity approvals this year alone. The last 3 months have seen particularly strong pipeline delivery, including first, the FDA approval for Zejula in first line ovarian cancer based on the outstanding PRIMA data, which resulted in a uniquely broad label. 2nd, the first regulatory approval for daprostat in Japan. 3rd, terrific prep data with cabotegravir that could redefine the management of HIV and most recently, receiving a 12:0 positive vote from the FDA's ODAC on belantamab mafedotin that was further endorsed by last week's positive CHMP opinion in Europe.
Turning now to Slide 22. We now have a biopharma pipeline of 35 medicines and 15 vaccines with 39 of these 50 assets having a direct effect on the immune system. I'd now like to discuss several of these programs in a little more detail. Starting with vaccines on Slide 23. I am very pleased to be able to share some great news on 3 of our vaccine programs.
First, RSV. Scientists have been pursuing RSV vaccines for more than 50 years but have only recently gained a fundamental understanding of how to induce protective immune response by immunizing with the pre fusion protein. This was used in both our maternal and older adult vaccines. It is important to note that 50% of infants are infected with RSV before they are 1 year old and virtually everyone gets an RSV infection by the time they are 2. In children, RSV can cause an acute bronchiolitis, which can lead to respiratory distress, hospitalization and even death.
In addition, RSV is an important pathogen in the elderly and high risk adults. Although pediatricians are keenly aware that RSV may cause serious illness in their patients, most interns are less familiar with the morbidity and even mortality associated with RSV in patients over 60. Given the lack of treatment options, this lack of awareness is understandable. In older adults, the infection can cause pneumonia, which can lead to hospitalization and it has been observed that the 1 year mortality in these patients may be as high as 25%. Our older adult vaccine not only capitalizes on the pre fusion antigen, but it is also combined with our ASO-one adjuvant to optimize the immune response as we did with Shingrix.
We hope that if successful, this vaccine will have a meaningful impact on people over the age of 60 who are at the greatest risk from this high disease burden infection. I'm excited to share that we have had positive readouts for both of these RSV vaccines and we are moving both into Phase 3. We hope to share these data with you in a more detail at a medical Congress later this year. In addition, we're also moving our 5 in-one meningococcal vaccine combining serogroups ACWY and B into Phase 3 trials this year. This will allow us to target the 5 serotypes that cause most cases of invasive meningococcal disease in one single vaccine.
Now moving on to HIV. For me personally, one of the most exciting pipeline data readouts this quarter was the cabotegravir prep study, which we announced had been stopped in early May. These impressive data were presented at the AGE 2020 conference a few weeks ago and demonstrated that long acting injectable cabotegravir administered every 2 months is 66% more effective than daily pills at preventing people from developing HIV. We look forward to discussing these data with regulators and are working with them on a path towards registration. In addition, cabenuva, our first long acting injectable has been resubmitted to the FDA for approval and we anticipate the response in early 2021.
Lastly, Rucovia, our 1st in class attachment inhibitor was approved at the beginning of the month for heavily treatment experienced adults who are living with HIV. Now focusing on the pandemic. I am proud of GSK's contributions to developing solutions for COVID-nineteen. The breadth of a response is summarized on Slide 25. As already mentioned by Emma, we have progressed a number of adjuvant collaborations to support the development of vaccines for COVID.
We believe that by improving the immune response, both cellular and humoral, our adjuvant will have a clinically meaningful impact on the COVID pandemic. In addition, by reducing the amount of protein needed for a vaccine, we will be able to increase the number of doses that can be delivered to those in need. I believe that our adjuvant may be underappreciated and may ultimately enable antigen based vaccines to have a superior profile to other approaches. 2 such programs have moved into the clinic and we expect preliminary data in August on the Clovis project. Additionally, our collaboration with Sanofi is on track to move into the clinic in September.
We're also working towards advancing therapeutic solutions for COVID via our collaboration with Vir Biotechnology, which we announced last quarter to accelerate the development of monoclonal antibodies to directly neutralize the virus. We will be starting the first of these clinical studies with GSK-one hundred and thirty six next month. This quarter, we also started the proof of concept study, OSCAR, with ottilumab, our anti GM CSF antibody for the treatment of severe pulmonary COVID related disease. GM CSF can act as a pro inflammatory cytokine that induces survival activation and polarization of monocytes and macrophages, which are thought to be implicated in the cytokine release syndrome, which occurs in severely ill COVID patients. We think this is an exciting program and we anticipate receiving data in the Q1 of 2021.
The next slide underscores that when looked at in totality, the medicines and vaccines we are developing to combat HIV, COVID, urinary tract infections, hepatitis B and many other infectious disease, as a result of our focus on immunology, has resulted in a world class ID portfolio with 24 medicines or vaccines in clinical testing, of which more than 80% are immune modulators. In fact, infectious disease now accounts for almost half our pipeline. This pipeline of 24 programs complements our existing marketed portfolio of more than 20 infectious disease therapies that together delivered almost $17,000,000,000 in revenue for DSKAN 2019. And now with this to the declared war on cancer, which has resulted in a marked increase in investments by the pharma biotech sector on discovering and developing important medicines for cancer patients, we are optimistic that the world's experience with COVID may lead to an increased focus on the importance and value of developing new therapies to treat and prevent infectious diseases. With that, I'd like to turn to another key portfolio within the R and D pipeline that has benefited from our increased focus on the science of the immune system, that is oncology.
Slide 27 shows you how our focus on immunology has helped strengthen our oncology pipeline where we now have 14 assets in development, 13 of which act by modulating the immune system. I'd like to briefly share some of the progress we have made over the last 2 years and flag key upcoming data we anticipate sharing with you over the next 18 months. We expect data in the second half of next year on PSR-thirty three, our LAG-three antagonist, which is currently being explored alone and in combination with tasartolumab in solid tumors. We also anticipate proof of concept data next year on our TYN-three antagonist, cabolumab. GSK-six zero nine, our iCUS agonist, is in a Phase twothree gated study for head and neck squamous cell cancer patients in combination with TEMPRA and we expect to see data in 2021.
Bintrafusp alfa, the TGF beta trap PD L1 bispecific, we are co developing with Merck Serono is on track to read out the pivotal study in second line biliary tract cancer next year. In addition, the L1 studies remain on track. Lastly, dasolumab, our PD-one inhibitor has been submitted to the regulators for approval in second line MSI high endometrial cancer. In the next slide, I want to introduce you to the newest addition to our immuno oncology pipeline. I'm excited to announce that our anti CD96 antibody, our first molecule being co developed with 23 andMe, has started Phase 1 this month.
CD96 is an immune checkpoint receptor expressed on T cells and NK cells. It is part of the TIGIT CD155CD226 costimulatory access as shown on this slide. We're excited by this asset as blocking CD96 from binding to CD155 allows CD155 to interact with CD226 and importantly activate an immune response analogous to how TIGIT induces its effect. This mechanism of action is distinct from and possibly synergistic with PD-onePD-one L1 inhibitors as well as possibly synergistic with TIGIT inhibition. It is important to note that this access was genetically validated by 23.
Me via proprietary algorithm using their unique data set. Turning to Slide 29, we move from our newest to the most advanced asset that modulates the immune system, belantamab mafodotin, which as you know has 4 modes of action: blockade of the BCMA receptor, delivery of the cytotoxic MMAF conjugate and importantly enhancing antibody dependent cellular cytotoxicity in phagocytosis due to a2 constellation of the Fc domain as well as inducing an immunogenic cell death. We remain confident in the positive benefit risk profile of belanaf in relapsed refractory myeloma patients and we are pleased with the outcome of the FDA's ODAC hearing earlier this month and last week's positive opinion issued by the EMEA CHMP. We take patient safety very seriously and are focused on helping physicians and patients understand and manage the corneal events as well as aggressively looking at ways to reduce the ocular events, particularly in earlier lines of therapy. Earlier this quarter, we dosed the 1st patient in the DREAMM-five study with Bellamaf and our gamma secretase inhibitor that we in licensed from Springworth.
Want to take a minute to share why I'm so excited about this combination. As you can see on the right hand side of the slide, the gamma secretase inhibitor is gamma secretase is responsible for clipping BCMA off the surface of plasma cells. We believe soluble BCMA may act as a sink for our ADC, potentially compromising efficacy. As you can see in the panels at the bottom of the slide, the gamma secretase inhibitor blocks the shedding of BCMA, resulting in higher expressions of BCMA on the surface of the plasma cell. And as such, you see greater cytotoxicity and an increase in ADCC.
If this effect translates into the clinic, we may be able to lower the dose of Bellamax and still have strong clinical activity. In addition to the combination with the gamma secretase inhibitor, we're exploring lower doses and less frequent dosing in the earlier lines where belumab will be given with other effective therapies. We're cautiously optimistic that these approaches will enable us to successfully develop elmaf in earlier lines of treatment. I'd like to speak about the most advanced of our all of our cancer medicines that is Digiulo. Despite having no synthetic lethal drug targets in 2018, we committed to becoming a world leader in this exciting field.
Our first step was to acquire Zejula based on the functional genomic studies that suggested PARP inhibitors should be effective beyond those women who have a BRCA mutation. We were pleased that the PRIMA study bore out this hypothesis, showing that the treatment effect in HRD positive patients was similar to that observed in remote BRCA mutation. In addition, because of its unique tumor concentrating effect, Zejula actually exceeded our expectations and demonstrated benefit in all comers, which has translated into a unique and differentiated label. As such, the TESARO acquisition validated our belief that functional genomes can be used to identify exciting underappreciated targets and we hope to expand this technology to find novel targets for patients with specific alterations in their tumor. Slide 31 shows what has been achieved towards this vision since PRIMA has readout.
Based on the PRIMA and other preclinical data, we are excited about the potential of Zojuolo to work in other tumor types such as lung cancer. And given its unique PK properties such as tumor accumulation and ability to cross the blood brain barrier, we believe we have the best in class PARPA inhibitor. We will start a Phase 3 study in first line non small cell lung cancer later this year. Our confidence in the concept of synthetic lethality has led us to build out our pipeline in this key emerging area of science. We now have 5 new synthetic lethal assets with one being our homegrown type 1 PRMT inhibitor, 3 coming from a partnership with IDEO that we just announced earlier this quarter and of course, Zejula.
We have also established a new research unit in Boston with a new leader in place. And I'm pleased to share with you today that we have agreed to a 5 year collaboration with 1 of the world's leading functional genomic centers, the Broad Institute, to help us advance our mission. Taken together, I believe we have made excellent progress on our goal to build an industry leading pipeline in synthetic lethality. Not only has our focus on immunology resulted in a strong infectious diseases and oncology pipeline, but we also have 10 other immune modulatory drugs that are targeting diseases such as osteoarthritis, systemic lupus erythematosus, rheumatoid arthritis, Duchenne muscular dystrophy, ulcerative colitis, systemic sclerosis, asthma and COPD. And I'm particularly proud of the team working on Benlysta.
We announced positive headline results from the BLISS study in lupus nephritis in December last year and we expect these data will be published in a top tier journal very soon. Furthermore, we anticipate approval of this indication early next year. In addition, the BLISSE BELIEVE study, unless in combination with tretoxantin for SLE, for readouts in a similar timeframe. We have also made excellent progress on Nucala. We have recently generated positive pivotal data in nasal polyps, filed for approval for hyperriocinophilic syndrome and resumed our pivotal study in COPD.
We're also exploring a long acting anti IL-five, which if successful will potentially transform the respiratory market in a manner similar to the way that cabotegravir may disrupt the treatment of HIV. Building on the previous slide, I want to briefly highlight the important impact that business development has had in supporting the transformation of R and D pipeline at GSK. The various deals outlined on Slide 33 will deliver significant value to GSK either by adding strategically targeted assets to our pipeline or providing access to world leading technologies and outstanding scientists that will help us progress the next generation of transformative medicines and vaccines to patients. Lastly, before I close with our upcoming pipeline milestones, I wanted to discuss culture. 2 years ago, I spoke about the importance of culture to an organization and how we were going to focus on creating the right culture within the R and D organization at GSK.
I'm delighted to share with you some of the results from the most recent GSK employee survey that demonstrates the progress we are making across R and D. Most importantly, we had an 8% increase in the engagement scores for R and D employees and a 20% increase in employees' belief in our commitment to scientific expertise. We were also pleased to see our focus on innovation was acknowledged by Science Magazine, where we were ranked as one of the top 20 companies to work for the first time. We've also worked to simplify the governance model across our pipeline to improve our agility. This improvement in our agility is best illustrated by Vir and the otilumab study in COVID-nineteen.
The VIR deal took less than 3 weeks to pull together and announce. And the Phase 2 OSCAR study took less 10 weeks from the idea to the 1st patient being dosed. Another great example is the speed with which the team Bellamax from essentially 35 patients in Phase 1 to the 10 study DREAM development program and hopefully approval in just over 2 years. As I mentioned earlier this year, I'm excited that we are combining our vaccines and pharma development organizations into 1 single group as I believe the opportunity for increased exchange of scientific ideas and expertise will greatly benefit our pipeline. And finally, we're seeing much closer working between R and D and commercial to improve our focus on lifecycle management.
This has resulted in many expansion indications under investigation for Zejula, Bellamab and LISTA and Nucola. Moving to my final Slide 35. Want to look forward over the next 18 months where we have a number of important milestones. We have a lot of work to do, but I would particularly like to highlight 4 areas as a priority. 1st, maximizing the patient impact of our marketed medicines such as the doula, benlist and Nucala.
2nd, bringing the transformational impact of cabotegravir to patients and treat HIV. 3rd, advancing our oncology portfolio by achieving approvals for belumab and dastarlimab while building a pipeline of future indication expansion and of course delivering proof of concept studies for a number of exciting earlier assets. And lastly, delivering our robust Phase 3 pipeline, including 3 new pivotal studies I mentioned earlier with our RSV and meningitis vaccine. Closing, let me say I'm extremely pleased with the progress we've made over the last 2 years and I'm confident that the approach we are taking is delivering. We will continue working to build a stronger, more productive and more innovative R and D pipeline.
With that, I will now hand it back to Emma.
Thanks, Hal. So in summary, we're confident in the underlying demand for our portfolio despite short term quarterly impact. GSK has been resilient and agile in its response to the pandemic, and we're successfully navigating the crisis and meaningfully contributing to solutions, while at the same time making sure we're delivering our long term priorities of innovation, performance and trust and on our 2020 areas of focus. We're building on the significant progress Hal has spoken to and strengthening our pipeline further. We're driving improvements in our operating performance.
We're progressing the consumer JV integration at pace, including the reshaping of our brand portfolio. And we started our program to prepare the group for separation into 2 new companies with relevant and competitive purpose portfolios and strategies. 1, a biopharma company focused on the science of the immune system and genetics, the other dedicated to everyday consumer health. Ultimately, we remain confident in the resilience and sustainability of GSK's business and our ability to deliver very successfully on our strategic goals. So we're now joined for Q and A by Luke, Brian, David and Roger.
And with that operator, the team is ready to take questions.
Excellent. Thank you, everyone. We now have Matthew Weston from Credit Suisse. Thank you, Matthew.
Thank you. Two questions, please. Firstly, for Emma. President Trump's proposed a number of executive orders on U. S.
Drug pricing, including international best price. As one of the first CEOs who's able to comment immediately after those announcements, I'd be interested in what's GSK's view on the proposals and what you would expect to shake out as we approach the election? And then secondly, probably for Luc, given the need for a vaccine rebound in the second half, can you talk about this year's flu season? How many doses are GSK targeting to ship versus last year? And should we assume price improvements given, I presume, high government demand for immunization across the board?
Thank you.
Thanks, Abi. So I'll take a look in a second, but just to comment on the executive orders, which, as you said, have just come out, we're reviewing that and monitoring how things evolve, obviously being conscious and thoughtful about what can actually happen ahead of the election. I mean, these are all all four topics have previously been raised and our position frankly is maintained as the same, which is we very much support any shifts that continue to drive access and support innovation that the world has never seen more than now is required for all of the unmet need. And we're very supportive of programs that lower out of pocket, particularly for patients that are under economic pressure. And likewise, due governance around access to 340B.
We do, however, have concerns about international pricing indices and importation, because global systems are not comparable and the focus should be on maintaining safety and quality of products and also incentivizing innovation. Nonetheless, our number one priority is continuing to focus on quality needed differentiated medicines. You all know that GSK has a strong track record in terms of responsible pricing. And actually, we have continued to innovate for access And that's visible when you think about 3 in-one respiratory with Trelegy, the fact that Zejula is a single treatment or indeed the whole growth we are seeing and investing in 2 drug regimens and of course our commitments to price responsibly for any COVID solutions. So, Luke, do you want to comment please in terms of the focus on the flu season, which we know is very important?
Sure. Thanks, Emma. Thanks, Matthew. So in the U. S, we expect to ship around 50,000,000 doses the upcoming season.
The manufacturing team has done a great job and we expect those to be in the market shortly. This is a critical part of our acceleration program for Shingrix. And that's up from $46,000,000 in 2019, which back then was about 19% of market share. And the U. S.
Is where we send 2 thirds of our supply. Thanks.
Thank you. Next question, please.
Thanks very much. This is Louise Pearson from Redburn. Thanks, Louise. Your line.
Hello. Thanks for taking my questions. I've got a couple on the RSV program, please. So firstly, in terms of revenue opportunity in the older adults, do you see this as a vaccine that could potentially support a premium price point like a Shingrix should this program ultimately be successful? And secondly, specifically on the maternal vaccine, is there any reason to believe your vaccine will be differentiated from the Pfizer maternal vaccine, which also recently came through proof of concept?
Thank you.
Thanks very much, Louise. And I'm going to turn to Roger. But absolutely, we do think that the RSV portfolio has tremendous potential, both in terms of unmet need and our competitive positioning. But Roger, perhaps you liked, not least by the way with our differentiated adjuvant, which is proven to work on all the people. So Roger, perhaps you would like to give a bit more details on that.
Fantastic. Louise, thank you. Yes, we are completely delighted with the positive data that we saw in the 2 RSV assets that Hal mentioned. I suppose it's worth pointing out both have fast track designation from the FDA also. Just on RSV older adults, we really think we are likely to be uniquely positioned here because of the pre AF antigen and the adjuvant that Emma referenced as well.
This is the adjuvant system in Shingrix is the AF01 adjuvant, which created greater than 90% efficacy in Shingrix. So again, that's creating a level of excitement, where we really believe that that could offer potentially wider and longer protection. On your pricing point, I think if we do create that level of differentiation and protection, that level of pricing is appropriate. But obviously, that has to be determined as we run through the trials. We're moving into Phase 3 in early 2021.
We are excited about older adult. On the maternal side, just in terms of it's the same antigen as the older adult vaccine. It moves into Phase III in the second half of this year. Two points of 2 points I'd really note here. Number 1, this is likely to complement other CDC recommended maternal vaccines that we've got in our portfolio as well.
So we've got experience in terms of how we operate in this maternal vaccination space. That will be the first one. I do think a vaccine offers potentially also polyclonal coverage versus in the competition we know also that we'll be up against monoclonal competition. And I think that could offer broader strain protection, which protects us against well, protects you against virus mutation or if viruses or strains actually escape the monoclonal. So yes, excitement in both of those.
The good news is we'll share the data on this in Q4 later this year.
Thank you. Next question please.
Sorry, on to the next, yes?
Next question is.
Thank you. This is Keyan Parikh from Goldman Sachs. Thank you, Keyan.
Good afternoon. Thank you for taking my questions. 2, please. First, kind of just on the cost trend that we're seeing this quarter, I mean, would love your thoughts on how do you see the sustainability of the growth in the cost as we go through the rest of the year? I think a lot of your peer groups seem to be reporting margins meaningfully better than expected.
So would be keen to hear your perspectives on how long do you think the need for reinvestment continues to be? That's question number 1. And then question number 2, on Zazula, I think kind of numbers are a bit below expectations for the quarter. Clearly, some stocking kind of moving from Q1 to Q2 or likewise. But look, would love your thoughts on how you think you're doing in the real marketplace, if you can refer to some market share trends?
And when do we anticipate a real pickup that justifies the value you paid for TESARO? Thank you.
Thanks, Keyur. So let's go to Ian first and then over to Luke.
Okay. Thanks, Emma. Keyur, thanks very much
for the question. Look, costs, I think
one of the differentiating aspects of our focus around capital allocation is investment behind R and D pipeline, key assets in the pipeline is absolutely key priority for us and you continue to see a cost increase in that regard as we invest behind those priority assets. So in the Q2, our pharma R and D up 13% and year to date overall for the company up 11%. That will remain a focus for us. On the other hand, on the SG and A front, in the quarter down 5%, very, very strong focus on all non customer focused activities. So we continue to invest in terms of supporting new product launches and completion of the build out in terms of specialty.
But if you think about the programs that we are delivering savings against integration of the consumer healthcare business, Brian and the team beginning now to deliver savings from that integration very much in line with the €500,000,000 we expect to deliver between now and 2022. The Future Ready program, separation preparation program by another name, beginning very, very early stages of delivery. But again, between now and 2023, dollars 800,000,000 of savings with the lion's share of that delivered by the end of 2022 with meaningful margin improvement. And then in addition to that, just the day to day tactical management of costs in the Q2, we've managed T and E down to a very, very small number. As you would imagine, conferences and meetings down to a very small number, find ways to continue activity with our customer, with our healthcare professionals through virtual means that's been particularly noted in the U.
S, which again takes costs out of the travel and entertaining, the fleet expenses for the sales force, for example. So there's a very strong focus across non customer facing activities as well as just continue to deliver productivity through the supply chain and the commercial organization. So happy with the progress in terms of 5% down on SG and A in the quarter, continued focus in that area, but we'll continue to invest behind SG and A sorry, SG and A between behind Priority Assets and R and D.
Thanks, Ian. Luke, the jeweler.
Sure. Yes. Thanks, Cara. So
Keogh, I'll answer this in
a few pieces. I mean, Ian's covered the inventory effect, which was plus 5 in quarter 1, and then we had a change in wholesale delivery from Monday Thursday, Wednesday Thursday, which was $5,000,000 in Q2. So that's a $10,000,000 swing there. But in terms of operational, I guess I'll split this into 2 parts, things that we can control and things that we can't. So in terms of things that we can control, I think we're doing well.
So first line market share jumped 14% to 21%. And again, if you look at the class, it's up 100% or close
to 100% in 12 months.
And we still only have 15% of women in first line getting a path. We had the leading share of voice to average at about 39% and actually got up to a peak of 49% because we rapidly changed our model when COVID hit. And then we also as soon as we had state level clearance and government clearance, we got straight back out there. If we look at message recall tracking, this is translating to strong and clear recall of our key messages, which again is encouraging. And then if we look at probably the most dynamic measure, which is the average new patient starts in the U.
S, this is actually at an all time high. So if you look at Q1 versus Q2, it's up 50% 58% and that's despite a big drop in late March and then most of April. And then finally, on things we can control, we've seen just over the last month, we've seen more than 400 new unique writers since pre month. So they're the things which I think were within our gift and I think we're competitive there. In terms of what we can't control, what is very clear when you look at the oncology market, there is a very dynamic trend here in terms if you've got slower progressing tumors than the referrals, the new patient starts and the in office treatment rates are lower and ovarian is in that category.
So if we look at new patient diagnosis, they're down about 10% in April. Debulking surgeries are around 25% in the last data that I saw. So these are factors that are out part of our control. But in the end, we launched Prima bang in the middle of COVID. And I think now our focus is to keep executing like we are, growing the class and making sure that we're getting our fair share.
Thanks, Luke. Next question please.
Thank you. This is now Tim Anderson from Wolfe Research. Thank you, Tim.
Hi. This is Richard Wagner with Wolfe Research for Tim Anderson. Question on the COVID vaccine. It's commonly understood that there are 3 major diversified vaccines players, GSK, Sanofi and Merck, yet all of the leading, the Vanguard COVID-nineteen vaccine initiative. So by none of the 3 biggies.
Instead, they're led by companies that don't at all have the same level of experience in this space. How did we end up in this place? I appreciate that GSK has multiple vaccine collaborations underway, but these are not commonly described as one of the leading programs. Was it because of the traditional vaccine companies feeling like vaccine development would be on the usual protracted timeline or something like that? That's the first question.
On belantamab, I know GSK doesn't give single product guidance, but can you at least tell us whether you think this product has the potential to achieve blockbuster levels of sales, meaning crossing the £1,000,000,000 or $1,000,000,000 threshold at some point? Thank you very much.
Well, thanks, Richard. And I can just say yes to your second question, subject to the program of work that Hal outlined. And maybe I'll ask Luke in a moment to just comment a bit further as we prepare for the launch on that. In terms of vaccine, I think it's interesting that you describe the leading programs as being from and I understand why from not the, I suppose, the largest vaccine manufacturers today. I actually think I would qualify a bit by saying the first.
All of us, I'd say across the industry, large and small, believe that more than one vaccine will be required to address this. And that's exactly why our decision right from the beginning was a) the vaccine is the priority exit here, but treatments will still be required because as you know, the FDA has also said they will consider approving vaccines with 50% efficacy. And even if extraordinary vaccine means that we're still going require treatments not just in the near term, but for long term, which is why we're invested in the areas that Hal talked about and excited actually about our prospects there. But it's also why the choice that we made in terms of technology play was to bring an adjuvant. And that is important because it's proven at scale, it's safe.
And we know it can add both efficacy and antigen sparing benefits as well as allowing us to have multiple shots on goal, if I can call it that. And you can see that evidenced by the way governments are engaging in contracting now is there's still a lot of uncertainty about what is going to play out in terms of results. We should all be encouraged by the early readouts, but these are often on totally new technologies that haven't ever been licensed yet. They are encouraging, but there's still a lot to see on duration of response and particularly on efficacy on different cohorts. And one of the big outstanding questions is what's going to happen with the older cohorts and the readouts there.
So we, alongside others across the industry, are still very much engaged in the programs we're in. As Hal said, we've got 2 already in the clinic, another just about to start. And we're very confident in being able to supply subject to positive results 1,000,000,000 doses of the adjuvant. Importantly, while still continuing and accelerating our existing pipeline and indeed investing in the exciting new technologies that are becoming more visible, be that in house or with our CureVac deal. So I think a lot more to come on in terms of where the vaccine solutions will conclude.
But Luke, is there anything else you'd like to add in terms of how you think about the upcoming commercial execution and prospects of Bella?
Yes. So, mean, look, I think the key thing to anchor on here is that there is striking single agent activity. And we believe that the side effect profile is manageable and it's an attractive infusion regimen. I think we can execute a good plan in terms of managing optimally managing corneal events. And I think also just when we talk to physicians that use the drug, again, the efficacy is attractive.
When in terms of managing the tox profile, let's see how that evolves and whether that's consistent with what we see with investigators once they get the drug in their hands and use it in patients and understand how it works. I think also you can see with programs that have highlighted like 3 in 5, we're also being open minded in terms of the pathways to this drug in earlier lines. So short story short answer is we remain very confident about the asset.
Thank you. Next question please.
Thank you very much. This is Andrew Baum from Citi. Thank you, Andrew.
Thank you. A couple of questions. COVID-nineteen is obviously going to have lots of impacts on the industry, but one that seems obvious to us is the importance of the government as a stakeholder is going to be materially greater going forward than it's been historically. With that in mind, to what extent does that influence your capital allocation? I'm obviously thinking of areas that you're already in, such as vaccines, but in addition, areas where you have been in historically, namely thinking antimicrobials and anti infectors more broadly, Is this a driver for you to increase your investment there?
And then second, on the announced deal in relation to vaccines, thinking about your pricing strategy for your COVID-nineteen, there's obviously a divergence between the AstraZeneca approach being pro bono for the during the pandemic period and obviously Pfizer and BioNTech going for profit. How are you thinking about pricing your vaccine for the pandemic period? Should there be safety and efficacy to meet approval? Thank you.
Well, thanks, Andrew. And I would definitely concur that the world and many governments have recognized the strategic importance of our industry and innovation within that and all in the context of the geopolitics that we know. I think in terms of how it's influencing our capital allocation choices, Hal laid out very clearly in his presentation, the mix of the portfolio of our pipeline, but also it's worth underpinning GSK's strength in infectious diseases, be that prevention, which frankly is if there's one thing despite any quarterly impact that we should all believe is that fundamentally we should be absolutely confident in the strategic relevance and prospects of vaccination, which is an area that GSK has tremendous strength, a growing pipeline and increasing competitive capabilities. But we also do have a broad infectious disease portfolio continuing to pioneer in HIV innovation. And I think it's really important to underline the opportunity we see with CAB both in prevention and treatment.
But also there's growing focus on antimicrobial resistance. And we have, again, as Hal mentioned, an asset in Jefferson there as well, which we believe does have appealing economic returns. So I think that's been clear. In terms of the pricing of vaccines, this is a business that we have long led in and under both the responsibility to drive access and the necessity to drive profitable returns and therefore to keep funding innovation and what on our position and we're not there's no publication from the government in terms of the specific detailed terms of that is that any short term profit generated during the pandemic period would be reinvested in pandemic preparedness and that and those donations for access. And pandemic preparedness is a combination of technology, new support for new pathogen work, but also the funding of ever warm capacity, very much with thoughtfulness for your first comment of the global footprint in terms of manufacturing and supply.
Next question, please.
Thank you. It's Laura Sutcliffe from UBS. Thank you, Laura.
Hello. Thank you. I've got two questions on RSV vaccine. Firstly, what sort of timeline do you think you might be looking at for Phase III readouts for both of your assets that you're taking forward? And secondly, your older adult vaccine is obviously adjuvanted.
I think previously the evidence has suggested there was little to no benefit from adding an adjuvant to vaccines that are going into this setting. Should we assume that since you're going forward, you have seen something remarkably different here? I know the data will be presented later this year, but any color you can offer us would be very helpful. Thank you. Yes.
I'm not sure you're going to get a huge amount of preview of data that's later to be presented. But Roger, would you like to follow-up for Laura, please, on those questions?
Yes. Laura, thank you. I'd say just on the older I won't share the data. We will publish and present later in the year. However, what I would say is that we have seen ASO-one obviously in Shingrix performing incredibly well in the older adult population where we know the age related decline in the immune system is critical.
So that's all I would say on that. In terms of timing, we are going to take RSV older adult into the clinic early in 2021. Maternal will be going into Phase 3 in the second half of this year. And these are going to be quite large trials. We'd expect them to take a few years to come up late with regulatory approval to follow on from that if it's positive.
What I would say is that certainly in the COVID environment, we're looking at clinical trial execution approach, regulatory engagement, and we'll be taking any learning in terms of how we do this effectively and efficiently into these priority programs.
Thanks. Next question please.
Thank you. This is now James Gordon from JPMorgan. Thank you, James.
Hello. Thanks for taking the questions. Two questions. The first one was just that your 2020 guidance is now caveated around the recovery in vaccination rates. And we are depending on what we see in Q3, we're a month into the quarter.
So can you talk about how much better things are looking for July and maybe what the exit rate is towards the end of this month? Is Shingrix, for instance, a good proxy for what's going on overall vaccines? Or do we need to be careful reading through from that? And then the second question was just the consumer spin off. I think when the spin off was first announced, there was a plan for 3.5x or 4x levered.
And the base case was you dividend the whole company to GSK and Fly to shareholders in 2022. Is that still the concrete plan or the default plan? Or might you do some other creative stuff like IPO in part of the business? Might you consider not putting quite so much debt in the business? Are there any other sort of things being considered there?
So thanks, James. I'll ask Iain to unpack the guidance and assumptions a bit more for you. But just say there's no change in terms of our position on consumer separation, be that former leverage or timing. So, Ian, any?
Yes. Thanks, Emma. And maybe Luke can add some color on this. But I think as Emma mentioned, James, what we are seeing through July is a significant recovery of pediatric vaccinations back pretty much to pre COVID-nineteen levels. Certainly, in the adult and adolescent vaccination, we're
seeing encouraging activity. It's not back to the
levels that it was pre COVID, and we need to see and we need to see that happen in the Q3 with a very strong performance coming through in the Q4. So we're encouraged by what we see so far And our very strong view is it's not a question of if this demand comes back, but when the demand comes back. And certainly what we've seen through the 24th July, which is the most recent July, 24th July is the data that we've seen most recently, certainly encouraged by what we see.
Thanks. Lou, do you want to talk a bit more about the activity that's ongoing? Thanks.
Yes. Just to build on Ian's point, I mean, is it clear difference when you look at the U. S. And Europe? I mean, Europe is the bulk of our business is pediatric vaccines, and that was rebounded relatively quickly in the U.
S. Pediatrics. If you look at the industry as a whole, in February, it was about 500,000 a week, and that dropped by 60% for 4 weeks in March April. And then it rebounded pretty quickly. So it was a V shape recovering.
So it was about minus 40% in late April and minus 10% in June. So it came back quickly, whereas adults, it dropped the same way, but it's been slower to recover. And so in early May, we're still around -50% plus overall for adult vaccinations, whereas Peds at that point was -30. So it's just a longer area under the curve. In terms of just wellness visits as well, we've seen the same path, so very strong rebound amongst pediatrics and 11 to 12 year olds and 13 to 18 year olds.
It's a slower recovery for older people. I think also when older people are going back into their physician, there's going to be a hierarchy that the physician is going to focus on initially. So blood pressure, etcetera, more acute dimension. In terms of what we're doing about it, again, we've not sat and been passive. So there's a series of things we've done.
We've initiated some well, firstly, we've linked it to the early flu dose, as I mentioned earlier, because people come in for the flu shot. That's a prime opportunity for the pharmacists to bring up Shingrix. We've also the field activity with our retail customers is back to pre target levels. And with retailers, we've got a lot of signage, volume goals and some other things that I don't want to disclose. And we've also been chasing people for their second dose and getting them back there, and that's holding up quite well.
We're also doing DTC at point of sale. And there's some other things, again, that I won't cover. But we're doing everything we can, including targeted TV and some branded digital and print based media as well. And as Ian said, I think we now need to see how that goes with the dynamics in the U. S.
Thanks, Luke. Next question, please.
Thank you. This is Geoffrey Porges from Leerink. Thank you, Geoffrey.
Thank you very much and apologies for jumping on the call later. I may ask the question you've already answered. But first on flu, could you just give us a sense of your timing for shipment to the U. S. Market, the volume change you expect compared to last year?
And most importantly, whether you see any net positive price due to mix or contracts? And then just to follow-up on the COVID program, when can we expect publication of your preclinical data, particularly primate data? And could you comment on the mix of CD8 and CD4 responses that you've seen with ASO in your other studies relative to COVID? Thanks.
Thanks. So Luke, I mean, we had the question on flu before, but perhaps you can just repeat what we're aiming for in terms of volumes roughly. And then Roger, I don't know if there's any further disclosure you want to bring on the or Hal on the COVID programs?
I can make a very quick comment, Emma, if you come to me.
Yes.
Okay. So, Jeffrey, shipping in July, linking and lining it up with the Shingrix acceleration program, we're targeting 50,000,000 doses. And also getting them in earlier, which is something I didn't say earlier, it's very important, it reduces the return rate that you see later in the year because physicians tend to over order. And that's up from $46,000,000 in 2019, which is just down to 20% of the market. And we sell 2 thirds in the U.
S. In terms of pricing flexibility, now it's very limited for this year
in the U. S.
Okay. Roger, anything more?
Color? Yes. I'm not going to go into any of the detail in terms of the data that we have seen. I'd make a more of a generic comment around I do think one of the things that is to play out in COVID-nineteen is this idea of immune response and T cell contribution to the performance of the vaccine then having potentially an impact on the population and the reaction of the vaccine in the population. What I would say is that adjuvanted vaccines have got that vaccines have got that historic delivery and track record of delivering both humoral and cellular immune response, which we think could very important for COVID.
Too soon to tell though, and that will all play out over the coming months as more data on our vaccines and on the other vaccines comes to light.
Hal, anything else to add from your point of view on that?
No, I just maybe to highlight something Raj has said, which is I think that the cellular response, it could very well be important in the success of vaccines. And I think in addition to measuring some of the classic markers that you referred to, I think GSK's vaccine research organization has put a lot of effort and I think a lot of innovation in actually what to measure, what is actually predictive in the clinic as to what you want to look for, for surrogates for that. So I think it's not only when, but the quality of what you might see is going, I think, to be interesting.
Great. Thanks, Hal. So one more question maybe quickly, if we've got time and then that's it for today.
Certainly. So Kerry Holford from Berenberg. Thank you, Kerry.
Thank you very much. A couple of questions. Just quickly on the flu vaccine. I'm just interested to know whether there's any upside to your ability to deliver more than 50,000,000 doses into the U. S.
Market. Sanofi is committed to ship, I think, 80,000,000. Interested to see whether there's any upside to capacity for you. And then just more broadly on the pipeline refresh for Hal, just is this something we should now expect to continue to see from you over the next on a 6 monthly basis going forward? And I wonder if you can talk to the reasons why you elected to deprioritize certain assets in the portfolio, the TLL for PI3 kinase and the HIV entry nematode?
Thank you.
Thanks very much, Kerry. And so Roger, just quickly from you in terms of capacity on flu and then how to conclude, please. Yes.
Our one of our highest volumes, the highest volume in the U. S. As well. We are very close to maximum capacity here. So there's limited upside going forward in terms of this egg based technology because it's not somewhere as you know as we've allocated lots of our capital to.
So you're not going to see much more in terms of upside above the $50,000,000 number within the U. S. Supply.
Thanks. So
Hal? Yes. Thanks, Terry. I think, yes, the answer is we will continue to focus our efforts in R and D on the most promising assets. And sometimes, the science will translate out nicely and we'll double down and be aggressive about developing assets and sometimes the data will emerge to suggest that we should abandon projects.
And of course, the risk is very high in the industry, 10% of projects that enter the clinic will ultimately succeed. And we think the most important thing is to follow the science and rigorously evaluate what the data in the clinic tells us. We think by this focus on human genetics, functional genomics, machine learning and particularly a focus on immunology will allow us to develop a portfolio that has a higher probability of success. And of course, by focusing, we have the opportunity to be developing and designing robust clinical trials to give us insights. So we're not faced with deep uncertainty that sometimes plugs the industry at the end of Phase II.
So I think the refresh is just our attempt to be rigorous scientifically and focused on the most promising assets.
Thanks, Al. And thank you to all of you for dialing in. We'll look forward to talking in Q2. Thank you very much.