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

Hello everyone. Welcome to our Q1 2022 conference call and webcast for investors and analysts. The presentation was posted to gsk.com and it was also sent by email to our distribution list earlier today. Please turn to slide two. This is the usual safe harbour statement and we'll be making comments on our performance using constant exchange rates or CR unless otherwise stated. Please turn to slide three. This is today's agenda where we will plan to cover all aspects of our Q1 2022 results. The presentation will last approximately 25 minutes, with a third of 35 minutes for questions. For those on the phone, please join the queue by pressing star one, and we request that you ask a maximum of two questions so that everyone has a chance to participate. Today our speakers are Emma Wormsley, Luke Miles, Deborah Waterhouse, Brian McNamara, and Ian McKay. The Q&A portion of the call will be joined by Hal Barron, Roger Connor, and David Redfern. And with that, I'll now hand the call over to Emma. Please turn to slide four.

thanks nick and hello to everyone joining today's call please turn to slide five i am very pleased to share our q1 2022 results which demonstrate a strong start to this landmark year for gsk with double digit sales growth we're delivering on our financial commitments to a step change in performance In the first quarter, sales increased 32%. Adjusted operating profit increased 39%, and adjusted EPS grew 43% to 32.8 pence per share. Sales growth was driven by excellent commercial execution and strong demand across the whole portfolio. Biopharma sales increased 40%, 15% excluding Zavudi. And across the three biopharma business areas, that meant medicines delivered 97 growth to 3.1 billion pounds with with strong double-digit growth across all areas particularly hiv i was pleased to see zavudi contribute to covid 19 solutions at scale and excluding zavudi specialty medicines also grew 15 vaccine sales increased 36 to 1.7 billion pounds driven primarily by shingrix which delivered its best quarter yet, more than doubling sales as we continue our global launch program across several countries and patient demand returned. General medicines also grew 3%, reflecting strong growth from Trilogy. And consumer healthcare delivered 14% sales growth in the quarter, benefiting from strong growth across all categories, particularly respiratory health. This is, of course, the last full quarter ahead of creating a new independent company, Halion, with a focused strategy to deliver sustainable above-market growth and attractive returns to shareholders. As a new standalone company dedicated to consumer health, Halion is a compelling prospect with an outstanding grant portfolio and fantastic leadership team, led by CEO designate Brian McNamara. We are absolutely on track with the demerger, having very successfully raised the necessary debt and delivered all significant technical system cutovers. Brian will share more on our progress and performance shortly, and I know he is very much looking forward to your questions. Our innovation-driven transformation, we continue to advance with recent regulatory approvals in specialty medicines, particularly HIV, with the US approval of CABINUVA every two months, the label update that makes the oral lead-in period optional, and the update for virologically suppressed adolescents aged 12 years and older living with HIV. In addition, the U.S. FDA also approved Trimec Pediatrics, the first dispersible single-tablet regimen containing dolotegravir as a once-daily treatment for children living with HIV. And in immunology, China approved Benlysta for active lupus nephritis. In the quarter, we continued our investment in R&D with the proposed acquisition of Sierra Oncology for $1.9 billion. We've consistently said we're pursuing targeted business development to augment and complement our organic pipeline. Great opportunities with strategic fit, and this acquisition aligns with our strategy of building a strong portfolio of new and specialty medicines alongside our vaccines portfolio. The deal is expected to contribute to 23 sales with adjusted EPS accretion in 2024. And in a moment, Luke will highlight why we believe momolotinib has the potential to address a critical unmet medical need in myelofibrosis patients with anemia and complement our heme-onc business. Overall, we see these results as a very encouraging start to the year, despite the reality of macroeconomic and geopolitical challenges today. We're very confident in reaffirming our full year 22 guidance, 5% to 7% sales growth, and 12% to 14% adjusted operating profit growth at CER. Turning to slide six. The first quarter was another period of excellent progress across all three of our long-term strategic priorities. In innovation, in addition to the examples I just gave, we also received the US and EU regulatory submission acceptances for DAPRODUSTAT, a potential best-in-class medicine for treating anemia of chronic kidney disease, and the US FDA has set a PDUFA date of the 1st of February 2023. In performance, our executional Edge needs to strengthen, as you'll hear from the team shortly. Although flattered by the comparison to Q1 2021, underlying demand is clearly strong. And lastly, on trust, we continue to progress our ESG leadership, executing our ambitious commitments to differentiate GSK on ESG delivery. Turning to slide seven. As our innovation-driven transformation gains momentum, 2022 is an important year for several significant late stage milestones. In Q2, we expect the results for RSV older adults with an anticipated regulatory submission before the year end, potentially putting us on a path for inclusion in the June 23 ACIF meeting. This disease represents a significant unmet medical need, with RSV infections accounting for around 180,000 hospitalizations each year and about 14,000 deaths in the over 65 population in the U.S. alone. In the second half, we have several late-stage readouts, including the Pivotal DREAM-3 trial readout for Blenrep in patients with third-line multiple myeloma and the Phase IIb data for beta-reversin for patients with chronic hep B infection. There is a significant unmet medical need for these patients with over 300 million people living with Hep B, and the disease is responsible for over 900,000 deaths each year. This is an exciting year for our high-quality pipeline, and I'm encouraged by the progress this quarter. And with that, I'll now hand it over to the team. Luke, first over to you.

Thanks, Emma. Please turn to slide nine. So in the quarter, our commercial pharma business continued to deliver strong performance. In specialty meds, including HIV, which Deborah will speak about momentarily, we increased sales by 15%, excluding Zaluti. We continued to see double-digit growth from our market-leading lupus medicine, Ben Lister, up 18%, and we were pleased to see the expansion into lupus nephritis in China and Japan, driving new patient studies. In oncology, cells increased 15% despite a headwind in the ovarian cancer area, where unfortunately, diagnosis rates are still depressed, down about 29% compared to pre-COVID levels. We're also pleased to contribute pandemic solutions with around 1.3 billion pounds of Zevuti cells in the first quarter. And as COVID is an ever-evolving landscape, we're having ongoing discussions with regulators and working at pace with VIA to add to the data set. On the right-hand of the slide, you can see that we've spotlighted the fantastic performance with Nucala, up 16% in the quarter. Nucala remains the leading IL-5 in key markets like the US, Japan, and the EU5, and it's the only biologically approved for four indications across isenophilic diseases. The new indications in deeper penetration and severe isenophilic ASPA represent further growth opportunities, and these are complemented by our long-term bicycle innovation plans with phase three trials for Ducala and COPD, and of course, our long-acting IL-5 Depomocumab, both expected to read out in 2024. And finally, our general meds portfolio was up 3% this quarter, with classic and established product declines more than offset by strong trilogy growth up 35% in the quarter. We continue to lead the triple market in the US and Japan with new, increasing new-to-brand prescriptions and overall market share gains. Now, if you could just turn to slide 10, please. Moving to vaccines, we had a very strong recovery for Shingrix, which helped drive sales growth of 36%. Shingrix sales more than doubled, delivering a record quarter of nearly 700 million pounds of turnover, and the strong performance is reflected in the benefit of a favourable comparator, good demand, and channel inventory build, including a large retail purchase that we do not expect to repeat in Q2. In the US, encouragingly, pharmacists are beginning to prioritise Shingrix as the second preferred vaccine, with around 50% now indicating they're looking to increase shingles vaccinations. In Europe, strong growth benefited from high demand in Germany and contributions from new launches as our geographic expansion is making Shingrix more widely available. Shingrix is now available in 19 countries globally, and our unconstrained supply position puts us on track to expand to 35 countries by 2024. making Shingrix available in nearly 90% of the global vaccine market. As shown on this slide, we see increased contributions from our geographic expansion efforts. And this year, we're on track for a record year for Shingrix with double-digit sales growth, and we expect contributions to build from new launch markets as we move through the year versus the stronger comparative quarters in the second half. Shingrix will be a key driver of this year's expected low team sales growth in vaccines, excluding pandemic solutions. And Shingrix is well positioned to deliver the ambitions we laid out last year for our 2026 commitments to growth. Please turn to slide 11. Earlier, you heard Emma highlight the strategic rationale for our proposed acquisition of Sierra Oncology. I want to now focus on the benefit of Momolotnib as a potential new medicine to address a critical unmet need in myelofibrosis patients with anemia. Anemia is a significant issue in myelofibrosis caused by two drivers. First, the natural progression of the disease where the bone marrow is progressively failing, causing cytopenia, of which anemia is the most frequent. And second, the standard of care treatments for myelofibrosis is dominated by myelosuppressive JAK inhibitors. Many patients sooner or later will become transfusion dependent. And on the left side, slide 11, you can see that transfusion is an independent prognostic factor with transfusion dependent patients having significantly worse survivals. This is a significant challenge with the right side showing how significant a challenge it is. Up to 30% of patients who still not receive a JAK inhibitor already require a transfusion. That number goes up to 70% of patients who've already been treated with JAK inhibitors. With Momolocnib, we're excited to have an opportunity to bring a potential new medicine to GSK, which is differentiated in a segment of patients with a higher medical need. With that, I'll now hand it over to Deborah on slide 12.

Thanks, Luke. Our Q1 performance demonstrates continued momentum towards delivering our objective of remaining innovation leaders in HIV and achieving a mid-single-digit sales category to 2026. We've seen continued momentum throughout the quarter in our innovation sales, which now account for 38% of our portfolio and all regions reported growth. Sales grew 14% during the quarter, reflecting strong confidence levels in our two-drug regimens and building momentum for Cabinuva. Q1 performance benefited from favorable tender phasing in the international region and stocking patterns in the U.S., accounting for around 9 percentage growth points. Our ambition for the year remains to deliver mid-single-digit growth. Dovato continues to perform strongly, delivering £257 million of sales, representing 82% year-on-year growth. Dollar-tegrafe-based regimens continue to hold the number one position in the share of the switch market across the US and Europe. Dovato is on track to deliver at least £1 billion of sales in 2022, with significant further growth potential beyond. Turning to our injectable portfolio. Cupid Cabinuva is our first-in-class, long-acting treatment regimen for HIV. Sales doubled quarter on quarter, delivering 38 million pounds, and more than 6,000 people living with HIV are now taking the medicine. The US FDA approved several label updates, simplifying the patient and physician experience. The approval and launch of the every-two-month dosing in the US in February has driven a positive inflection in the medicine. Cabinuva oral lead-in is now optional. We believe removing the oral lead-in requirement will expedite the initiation of this injectable therapy. The US FDA also approved an expanded indication for Cabinuva to include virologically suppressed adolescents age 12 and older living with HIV. Moving on to prevention, we've launched Apertude in the US. Apertude is the world's first long-acting injectable for the prevention of HIV, dosed every two months. We have high levels of ambition for this medicine and the initial launch activity centers on building awareness and access for Apertude with positive early demand from patients and prescribers. I'm also pleased that we have made significant progress to enable access to this medicine in resource poor countries by announcing an extension of our partnership with the Medicines Patent Pool, which has been incredibly successful in enabling access with to more than 22 million people now taking a dolotegravir-based regimen. Finally, the US FDA approved Triamec Pediatric, the first dispersible single tablet regimen containing dolotegravir, a once daily treatment for children living with HIV. To ensure that none of the 1.7 million children living with HIV is left behind, This approval means we are one step closer to closing the gap between the HIV treatment options available to adults and children. I will now turn it over to Brian. Please turn to slide 13.

Thanks, Deborah. Turning to consumer health care. Before taking you through first quarter results, let me give you an update on the demerger process, where we've made significant progress as we enter the final stages of separation. During the quarter, we launched our new company name, Halion. hosted our first Capital Markets Day, and appointed to the designate board. We also secured the long-term capital structure of the business, raising bonds across a variety of maturities at attractive rates, and we established our debt facilities. Finally, we completed the technology systems cutover, a significant milestone for us. Looking ahead, the next major steps include the publication of the equity prospectus in June with a shareholder vote in July. In the first quarter, we had a strong start to the year. Revenue was up 14% and up 16% organically, driven by robust commercial performance with broad-based growth across all our categories and regions. Strong cold and flu performance delivered a 5 percentage point benefit to overall growth, and advanced sales ahead of the system cut over in April contributed a 2% up list. Our first quarter organic revenue growth was split 3% from price and 13% from volume and mix. This growth was also competitive with positive momentum in our overall market share with seven of the nine power brands holding or gaining share. E-commerce sales continue to see strong growth in the high teens, and this is now 9% of revenue. Similar to consumer peers, we saw continued pressure from cost inflation. However, Operating leverage and pricing combined with the delivery of the Pfizer synergies enabled us to increase operating margin by 230 basis points at constant exchange rates to 24.7%, while increasing investment in A&P and R&D. Given the very strong growth in the quarter, we remain confident in delivering full-year sales in line with our medium-term organic annual revenue guidance of 4% to 6%. Please turn to slide 14. Taking you through our performance, starting with growth for the quarter across our categories at constant exchange rates as a segment of GSK. In oral health, sales increased 9%, with continued strength in Sensodyne and Paradontax, supported by a continued rebound in denture care. Pain relief was up double digits, with over 30% growth in Advil and Panadol, positively impacted by Omicron, along with a stable performance in Voltaren. Across vitamins, minerals, and supplements, 15% growth was driven by the strength in Centrum and Emergency, benefiting from increased capacity to meet strong consumer demand. Respiratory sales were up over 50%, driven by a strong cold and flu performance, where brands were up nearly 90%, overall delivering about a 5 percentage point benefit to overall growth. Digestive Health and other sales were down 1%, but excluding brands divested, up 4%. In Digestive Health, Eno and Tums performed particularly well. Please turn to slide 15. The top of this slide shows how GSK reports our business by region. However, I'd like to take you through the Helion regional detail and our organic revenue growth. This is how we'll report going forward, and is consistent with what we shared at our capital markets day. North American sales increased 17 percent, helped by strong growth in respiratory in the U.S., where cold and flu was ahead of 2019 levels. Additionally, during the quarter, pain relief was up over 20 percent, driven by strong Advil sales benefited from resale stocking patterns and the Omicron wave. We also saw strong growth in VMS, particularly in emergency. Asia Pacific was up 15%, helped by COVID-related demand, with double-digit growth in Southeast Asia, India, and Australia. In China, we also saw double-digit growth, with Centrum up over 20%, and good growth in Caltree and Sensodyne. In Australia, we saw strong growth of Panadol, with sales up nearly 50%. Finally, looking at Europe, Middle East, Africa, and Latin America, First quarter sales were up 14%, or 10% excluding the sell-in ahead of the system's cutover and a distribution model change. This was particularly strong growth in Latin America and Central Eastern Europe. Additionally, Southern Europe saw a double-digit growth in Spain and Italy. The strong growth in respiratory was a key factor, along with good growth across a number of our power brands, including Sensodyne, Paradontex, Panadol, and Centrum. All of this offset some weakness from Voltaren in the region. So overall, a very good start to the year, clearly demonstrating the strength of execution across our markets. Looking ahead, we do expect macroeconomic pressure increase over the course of the year. And in the back half, we have a tougher comparator with double digit growth in 2021. We remain confident in delivering on our in-year and medium-term guidance of 4% to 6% organic annual revenue growth. Finally, I'm incredibly proud of our teams and the business's ability to navigate the volatile trading environment over the last couple years, while at the same time making strong progress towards separation. Along with everyone across the business, I am excited about the potential of Halion and our future as a standalone business from July. I look forward to engaging with you more on Halion as we get closer to separation and thereafter. I'll hand it over to Ian.

Thank you, Brian. As I cover the financials, references to growth are at constant rate rates and less stays otherwise. Please turn to slide 17. For the first quarter of 2022, turnover was 9.8 billion sterling, up 32%, and adjusted operating profit was 2.6 billion sterling, up 39%. Total earnings per share were 35.9 pence, up 66%, while adjusted earnings per share were up 32.8 pence, up 43%. Pandemic solutions contributed approximately 11 points of growth to adjusted operating profit and 15 points of growth to adjusted earnings per share. The currency impact was neutral in sales and adjusted earnings per share. The main adjusting items of note in Q1 were in disposals and other, which primarily reflected the upfront income from the settlement with Gilead, and in transaction-related, primarily reflected VEEV CCL movements, which were mainly associated with foreign exchange. My comments from here onwards are in adjusted results, unless stated otherwise. Turn to page 18. Total sales growth was 32% driven by strong performance across the group. Total sales growth for GSK's commercial operations segment was 40% overall and 15% excluding pandemic-related sales. This reflected strong all-round performance, as all product areas benefited from strong demand trends and the continued recovery from pandemic-related disruptions, which provided a favorable Q1 comparator. All of the 15% ex-pandemic growth, around 4 percentage points were from Shindricks in the US, including the channel inventory build, as well as broad demand recovery. Around three percentage points were from HIV, of which about two-thirds were tender phasing, U.S. ordering patterns, and U.S. channel inventory movement that we expect to reverse in Q2. And with approximately an additional point for each of Augmenton's seasonal rebound and favorable RAR adjustments. Taken together, adjusting for the benefit of Zabudi and the dynamics I've mentioned, commercial operations growth was in the high single-digit range. Brian's already taken you through the sales performance and consumer, and the key category drivers are set out in this slide. Turning to the next slide. The group delivered 130 basis points improvement to 26.7% adjusted operating margins, supported by positive operating leverage from the 32% sales growth. Within cost of goods sold, the increase primarily related to higher sales in Zabudi which increased the cost of sales margin by seven percentage points. Excluding Zabudi, cost of goods sold were a 1.7 point benefit to margin, driven by favorable business mix, with 60% of commercial operations sales ex-pandemic being from specialty medicines and vaccines, compared to 55% in 1Q last year. This mixed benefit was partly offset by a modest increase in commodity prices and freight costs, which we continue to manage closely. Within SG&A, we continue to see tight control of costs, which remains a key focus for us, as well as restructuring benefits. The SG&A growth reflected increased investment in launches, particularly in HIV, vaccines, and a more normal level of brand investment in consumer. There was also a beneficial legal settlement in Q1 last year of around £60 million. Moving to R&D, the 7% increase was primarily driven by increases in the vaccines portfolio, including RSV for older adults, meningitis, and MRA. Specialty medicines investment decreased, with reductions in the late-stage specialty medicines portfolio partly offset by increased research investment as several early-stage assets progressed into Phase 1. Royalties benefited from higher sales of Gardasil along with the first contribution of royalty income from the Gardasil settlement, which started in February. For the group excluding consumer healthcare, adjusted operating profit was £2 billion, up 44%, and the adjusted operating amount was 27.5%. The benefit from pandemic sales contributed approximately 15 percentage points of growth to adjusted operating profit, and reduce operating profit growth, sorry, and reduce the adjusted operating margin by approximately 2.5 percentage points. Overall, our margin progress is shaping up well as we execute against the plan we set out in June last year. We do expect some quarterly variation in light of the 2021 phasing, but fully expect 2022 to deliver improvement on last year and represent a positive step towards our 2026 targets. Turning now to slide 20. Moving to the bottom half of the P&L, I'd highlight that interest expense was £202 million slightly higher due to adverse movements in foreign exchange and newly issued helium bond debt, and that the effective tax rate of 17.9% was aligned with expectations for the group. On the next slide, I'll cover cash flow. In Q1, we delivered £1.7 billion of free cash flow and cash generated from operations of £2.8 billion. The key drivers of higher fee cash flow were as follows. Significant increase in operating profit, including the upfront income from the Gilead settlement. Favorable timing of collections and profit share payments for Zabudi sales. For note, we expect to see an opposite impact in Q2. And lower seasonal increases in inventory. These factors were partly offset by lower proceeds from disposals and higher purchases of intangible assets, primarily Elector and Arrowhead, as well as higher tax payments and capital expenditure. We still expect to share comparators for new GSK cash flow around the middle of the year. Turning now to guidance in slide 22. Today, we're reconfirming our GSK guidance for 2022. Excluding COVID solutions, we still expect to see GSK sales growth of between 5% to 7% and adjusted operating profit growth of 12% to 14%, which continues to be predicated on the consumer healthcare business being demerged in July. Our expectations for COVID solutions also remain unchanged, with the overwhelming majority of sales delivered in Q1. We are assessing demand for the remainder of the year in light of the US FDA change to the emergency use authorization for Zabudi. We've delivered a very strong start to this pivotal year, and I should share some of our considerations for the remainder of the year. We anticipated a stronger Q1 in light of the phasing of the pandemic impact in 2021, there has also been some favourable phasing this quarter such as the timing of international tenders and HIV and in US vaccines ordering patterns. In light of those Q1 dynamics and prior year performance we expect quarters two and three to deliver lower sales growth with a favourable Q4 comparator also informing 2022 phasing. At the half year we would expect to be slightly ahead of full year revenue guidance with second half will look more heavily influenced by Q4, given the 2021 second half comparators. On dividends, we've declared a 14 pence per share for the first quarter. In summary, the strong start to the year and the momentum we have give us confidence in delivering our guidance, while also delivering the separation into two new companies. And with that, operator, we'll now move to Q&A. Thank you.

Great, thank you. Everyone, if you have a question on the line with us, please press star 1 on your device. If you then decide to redraw your question, simply press star and 2. And we already received a few questions, and the first one is coming from the line of Graham Perry from Bank of America, Maryland.

Great. Thanks for taking my questions. So I just wanted to follow up on Shingrix, and if you could just quantify the benefit of inventory movements in the U.S. as the retail channel restocked and where inventory levels were at the start of Q2. Could we see any unwind there in Q2? And then XUS, is there any bolus effect in Q1 or expected through the rest of the year as new launch markets come online? And then secondly, one for Brian on consumer, the inflation impact on input costs that you're seeing, And any potential wage inflation going forwards, could that impact on your margin expectation at all? And could cost of living affordability issues start to see consumers downgrade from the premium brands in OTC and orals that GSK sells and go more towards cheaper, generical store brands? Thank you.

Thanks, Graham. Well, because it is an important occasion for us, I'm going to offer the first question there with great pleasure to Brian to answer, and then we'll come back to Ian to give a bit more detail on the Shing-Rix phasing. I think he already made some comments, but you might want to add something to that.

Thanks for the question, Graham. So the question on inflation impact and input costs. I think as I laid out at Capital Markets Day, we are exposed to the same inflation costs that many of our consumer peers are seeing, but we are less exposed structurally. So if you look at the commodity and commodity-related costs, it's less than 10% of our overall sales. So we're seeing those cost increases, but I feel really good about our margin delivery in Q1. And the margin delivery was driven by a combination of the continued delivery of the Pfizer synergies along with operating leverage behind the Strong's growth. Now, it's also just important to note as you look at that operating delivery, margin delivery in Q1, we are yet to see the full standing up of the Helion costs we shared at Capital Markets Day. of $175 to $200 million. They haven't ramped up yet in Q1. So for the outlook on the year, nothing has changed from the margin building blocks we provided for 2022. We laid out at Capital Markets Day and in our medium-term guidance of moderate margin expansion, and we're managing all the other costs. And as we said, we manage it with a combination of efficiencies in the business and with pricing. Your question on consumer behavior, I have to say to date we have not seen consumer behavior impacted in demand, and you see that in the strong volume growth that we had in Q1. We're staying very close to this, and we're seeing how consumer behavior shifts. It's also why we're very focused and conscious of where and how we take pricing across the business to make sure that we don't get ahead of that consumer behavior. The other piece is, listen, we're in everyday health. We're in consumer healthcare, and these products matter. And products like Sensodyne provide a real benefit to consumers. So while premium, we tend to see consumers sticking with those products that really matter.

Right. And, you know, 11% volume growth in consumer in the quarter, you know, is real strong underlying. Ian, on shingles?

Yeah, brilliant. Thanks, Brian. Since it's the last quarter, do you want to take the question on Shindrix as well? I'd love to, Ian. Thank you very much. So, Graham, thanks for your question. So, look, a couple of comments I made during the presentation. We saw about four percentage points of our 15% ex-pandemic growth in commercial ops coming in Shindrix in terms of the U.S., phasing in terms of the underlying demand recovery from patients, which is incredibly encouraging, something of which we're confident, but nonetheless encouraging to see. But in terms of the channel build and that phasing, if you look at inventories at the end of the first quarter, inventories sitting around 1.2 million doses, It was around 1.1 million doses at the end of the fourth quarter. So it really was very much about just building that demand that we saw coming through in the first quarter. So confident in that. In terms of looking at how we see the contribution from geographic expansion, it'll build as the year goes on. But when you look at markets that make the real difference at this point in time, it's that continued underlying demand, strong demand coming from the U.S. But also our German market in Europe plays a very important contribution now to overall Schindler's performance. So I think, you know, I just build on some of the comments that Luke made in that regard, that as we continue to expand on the back of unconstrained supply, we will see the contribution build, but key markets certainly in the current year would expect to continue to be the US and Germany to a somewhat lesser extent.

Thanks. Luke, anything you want to add at all in terms of the consumer demand dynamic?

yeah i think it's probably the color there i mean i think just to build on thanks emma to build on ian's point i mean q1 2021 was 0.7 million doses and q4 2020 was 0.8 million doses so i think if we've learned one thing about the pandemic is retail pharmacy chains in the u.s is a pretty good judging command of shingrix as ian said there was a large order from the pharmacy chain in the u.s and we'll unwind that in q2 but they you know they ordered it because they think they could sell it Now, on the demand side, to Emma's point, I mean, the good thing is that the DTC that we've got is breaking through. Our target segments, you know, we can see increased urgency and interest. Also, when we look at physicians, nine out of ten of them are willing, very willing, to prescribe the product in 60-plus years. And that's actually jumped 10% in the 60 to 64 group. It's also moving up in the 50 to 60 group as well. What's also encouraging... But again, we're not out of the woods yet, and I'll explain why in a second. We run a survey with pharmacists where we ask them to allocate 100 points in terms of their enthusiasm to recommend vaccines to patients. So the end of last year, they allocated 56 points to COVID-19, 10 to shingles, 8 to pneumo, 21 to flu. So there's some seasonal there. If you look at February, they allocate 39 to COVID, 23 to shingles and shingrix. 17 to pneumococcal vaccines and eight to flu. So that's certainly encouraging in terms of them moving it up. And then when you ask them specifically on Shingrix, you know, you're more willing to use the product. They've gone from 44% extremely willing at the end of last year to 56%. So there's a real strengthening in terms of their enthusiasm for it. And we're now starting to see that in the Rx trend. So 42 out of 50 states We are more TRXs than same time last year. And out of those 42, 36 are more than 10% up. And 10 of the 42 is more than 50% up. And about half those TRXs are the first dose, which if we look at this time last year is about one third, 35%. But, and this is why we're not out of the woods yet, we've seen COVID cases going up in the last two weeks in the majority of states. In the US, we've got two new sub-variants of BO2. And that's jumping in the north-east and mid-west. And you've also seen the Biden administration approving boosters for the 50-plus population. And then the other thing that we're watching very closely when we survey pharmacists, 45% of them said they have a very, very hard time hiring technicians and keeping them, and 40% said it's very different. And this is our number one reason for people not going through the shop. It's just the availability of staff. So, as Emma said in the unit, said, look, there's good underlying trends, we just need to watch and that's why we're not changing the album.

There's probably one other detail to add because I suspect we'll get this question later. So when you look at the volume through the retail chain versus through the healthcare provider's office, the practitioner's office, if you think about the third quarter of 2021, we saw 47% going through retail, 53% through the practitioner's office at the end of the first quarter or for the first quarter, we'd seen that start moving back to the more historical pre-COVID trend that we'd seen for Shendricks with about 56% going through the retail chain and 44% going through the practitioner's office. And so that, again, I think it plays to exactly the survey data that Luke mentioned. So it's encouraging to see that as well, but just keeping a very close eye on how we see the ability of those retail chains to administer when they see computing forces coming through.

Great. Well, we'll move on to the next question. We just know that that is a really key one. And as you can hear, there's a lot of vigilance, agility, and optimism remains for this great asset for us before the next one comes. Next question, please.

Thank you. Our next question is coming from the line of James Cooter from J.P. Morgan.

Hello, James Gordon from JP Morgan. Thanks for taking the two questions. Both pipeline, please. First one is on vaccines. So older adult are received phase three readout approaches. My question is latest thoughts on the competitive positioning and two bits within that. One about dose frequency is annual vaccination now the base case, in which case the adjuvant may not make a big difference in terms of allowing multi-year dose intervals. So how are you thinking about that? And also just competitive delays, whether that's a big boost for you. I've seen Pfizer have significantly enlarged their trial enrollment. I think they're going to report this quarter. And I saw J&J have started a trial with what looks to be a new viral vector, maybe due to blood clot safety concerns. So might you be the only one that applies to ACIP next year? So how are you thinking about that? And then the other question was about pipeline and oncology. So the Sierra Deal and Momi, which looks like an attractive option for Jacobi refractory patients, I know there are quite a few other mechanisms out there in late stage development like Bet and BSL2. So how are you thinking it's going to stack up in refractory? Is there like one big segment you could identify that you're going to go for, how we should segment the market? And longer term, is this just a refractory product or do you think you might be able to combine this with some of the other mechanisms and it could be a frontline product as well?

Okay, well, we'll come to Hal in a moment. both in terms of the trials. I mean, we already confirmed our expectations to have those results, but on that, and then your comments on oncology. But first of all, perhaps, Roger, you could comment on our overall sort of ambitions and confidence in older adults and any further reflections on questions like dose frequency as well.

Then we'll come back. Jim, thanks very much for the question. Obviously, we are able to see the data from our RSV older adult trials. Exciting time. within vaccines, obviously the disease burden and the world is waiting for a vaccine in this space. Emma mentioned the hospitalization burden that exists. And one thing to understand about that hospitalization is that the greatest burden comes from people that suffer from comorbidities in the older adult population. I mention that because when you look at our unique technology platform, which is the adjuvant combined with the antigen, We believe that's where we could see some differentiation in terms of performance. We've seen this in Shingrix. We know this platform well. We know that there's an opportunity to perform and create a higher efficacy in that older adult population and also in that at-risk group, the comorbidity group within older adults as well. So we'll have to see the data, but that's where we really believe that we can make a difference. I think it builds off the phase two data. That's why we're confident we see our phase two in terms of neutralizing antibody increase, but also the impact on T cells, which again, our belief is that that has that linked to severe disease outcomes. We believe that's the potential differentiation as well. In terms of adjuvant and duration of protection, we think the biggest goal that we have at the start is to protect the whole year. and ensure that we cover the season. That's going to be important. And then we'll obviously continue to monitor and see whether there is a duration of protection benefit greater or more than that season, and the trial is designed to monitor that as well. But we'll see that over time. I think that's important. What I would emphasize is that we are getting ready for this launch and investing to be ready as well, not just from a commercial perspective with Luke, but also from a manufacturing perspective also to make sure that we are ready for what could be a differentiated vaccine, and we're on track just to see that data in the first half of this year.

Right. Thanks. So, Hal, do you want to pick up any further comments on that and then also on CR-ONC?

Yeah. No, I think Roger hit all the points there, so nothing to add. I must change your additional thoughts on that question. So, imelatinib, I think, you know, is a very exciting molecule. For very significant on the medical need, I think that the question you specifically asked about that BCL to other concomitant meds. I think it's important to really highlight what Luke said, and why we're so excited about that molecule. What Sarah oncology was able to do based on some pretty interesting preclinical data showing that not only is this a very effective Jack 1 to inhibitor, but it has a unique property that will, I think, differentiate it amongst other. therapies for myelofibrosis, and that is inhibition of the so-called ACVR1 or ALK2, the activin-like receptor 2 kinase. And the science behind that is that by blocking that receptor, you're reducing hepcidin levels, which are involved in iron storage in the liver. And as you know and has been highlighted, anemia, not only because of the disease, but also because of JAK1,2 inhibition, which occurs with JAK of C. This sort of unique aspect of its mechanism, both the JAK1,2 inhibitor plus this ALK2, provides a very unique and differentiated profile. So it will likely be differentiated amongst all JAK inhibitors and possibly as a drug of choice to combine with other things. And so we're looking forward to seeing its lifecycle management in the future.

Great. Thanks, Al. Next question, please.

The next question is coming from from UBS. Hello, thank you. Just a follow up to James's question on the RSV vaccine, please. You've obviously mentioned that you might be able to get the data to an ACIP meeting mid next year, but how do you think ACIP is going to handle a discussion around how often your product should be given if you don't have much data on that at the time? And I think the relevant part of your trial will still be underway. It just seems unlikely they can make a recommendation without actually saying when you should have it. And then secondly, on consumer, you mentioned pain relief benefiting from Omicron in the quarter. That doesn't sound sustainable. So perhaps just your view on the evolution of that sales line for the rest of the year. Thanks.

Thanks, Brian. Do you want to pick up on pain relief and then how any further comments on?

Yeah, great. So thanks for the question. So Omicron impacts our business in two ways. First, the Omicron systems are consistent with cold and flu. So that drove the growth in the cold and flu category that you saw. And as you know, the cold and flu category grew significantly versus 2021 when we had very little cold and flu. But this year was also above 2019 levels. Second, in times of higher cold influences, we also see increased demand of systemic pain relief, especially brands like Panadol, which treat fever and symptoms. And Panadol specifically had a very strong Q1, both from treating those cold and flu symptoms, but also behind our Take Care campaign, which helped people understand how Panadol could safely alleviate symptoms post-vaccination. Now, unlike the beginning of 2020, where we saw huge demand from COVID that was pantry loading, this is real for consultants. So consumers are buying the product and they're using the product. So I just think about it as it was a strong cold and flu season, and, you know, we'll be lapping a strong, you know, that's an extension of what happened in Q4 and continued on. So that's how I would think about it. But I feel really good about the growth of both our respiratory and pain relief in the context of that market, because I feel we were very competitive in our growth rates.

Great. Hal, any brief comments on ACEP? Obviously, the work lies ahead, but

Yeah, I think the key thing is that, of course, we will be looking at whether this vaccine can be seen as super seasonal by the duration of protection, which we have ongoing pivotal data that will assess its efficacy over not just this one year time period where we'll obviously have data for ACIP, but to your point, over the ensuing years, and we have studies out the three years that are looking at the impact of this. we will be able to generate the data. I think it is important to also note that the duration of efficacy during a season can give some hints as to whether one might be able to see a super seasonal effect. But to your specific question, with one season's worth of data, that's what we'll have at ACIP.

Great. Thanks. Next question, please.

And the next question is coming from the line of Simon Mather from the MPCIRCAS.

Well, thank you. I've got two questions. I'll follow through one for Brian and then one farmer. Just in terms of OTC, could you maybe help us understand, you discussed stocking in the first quarter. Should we expect that to unwind in Q2? And kind of related, and please excuse my ignorance, but when you transition from the orange GSK emblem to a green halion, should we expect that to have any impact on revenues at all, or is that just purely academic? And then secondly, on pharma, one for Luke really, just on oncology, talking about obviously impacts of COVID-19, I guess we have similar impacts in the prior period. I'm just thinking what, excuse the noise, I'm just wondering what potentially we could, when we could see an inflection there, any data points, because obviously your guidance is for, I think, 7 billion peak sales and, excuse the noise, and just whether or not we're going to get an interim readout with the GSI that could potentially give us more visibility on blend rec. Thank you.

Thanks. You cut in and out a little bit. So I'll ask Brian, first of all, to comment on your stopping and technical question. By the way, obviously, philosophically, The concept of the demerger is to unlock tremendous growth for two new companies, so I'll give you that, but I'll let Brian talk. And then I think you were talking about oncology in the second question. It cut out for me a bit, but in which case, perhaps we can ask Luke briefly to talk about commercial performance and how briefly on the emerging oncology pipeline, it's still an emerging business for us, numbers you referred to are obviously on a non-risk adjusted basis. But, you know, we do have some exciting prospects coming through. But Brian first.

Yeah, thanks for the question. First on your question on stocking in the quarter. So one thing will not repeat and will come out of quarter two, which is the forward buy from the system cutover. So purely two points of growth that would have happened in Q2 came into Q1. So we'll see that unwind in Q2. The other comments on inventory stocking patterns are honestly the strong demand ending last year meant inventory levels were a bit lower at the beginning of the year. So those inventories are now up. So that's not something that would necessarily unwind as we look at the vote as the year goes on. But certainly next year in Q1, we have that inventory build that happened. But it's just normal kind of stocking patterns given the high demand across the business. Your question about orange to green, by the way, I just want to say I love the color orange, but I do like green better. There's really no impact. There's a slight difference in the parameter in the Halion numbers, and what you'll see at Capital Market, we shared the historical financial information under that parameter, and Tobias Hessler, and in the appendix of that presentation was a detailed list of what those changes are. Very small, so it doesn't have a significant impact on the reporting, but the numbers move around just slightly.

okay great uh luke do you want to talk about oncology momentum and then how long the pipeline is the gsi sure um so i think i heard your question correctly um i'll just go through the the products and then finish on blender as a segue to how on the pipeline race there i mean i think with the jeweler we've shown you the 29 suppression i think another set of numbers which are really illustrative of the challenge um for the class actually is if you look at iqvia U.S. PAP initiations across all lines. You look at Q1 2020, it was 1629. If you look at Q1 2021, it was 1487. And the most recent figures we have with IQV are Q4 21, and they're 1198. So those patients, sadly, those women are not presenting. They will present at some point. I frankly thought we would have seen a recovery by now just because of the underlying biology and the symptoms. But that's still lagging. So it's difficult to predict. And, of course, then there's a debulking timeframe before they present for chemo and then maintenance therapy. So I think it's the second half of the year at earliest. Look, on the encouraging side, though, with the doula, when we do see those patients prescribed a PARP, we're able to match them part of the one-for-one in terms of volumes there of scripts. So clearly that's, you know, I think the sign that we are cutting through in terms of the arguments there. If you look at Gemperley, I think the Ruby first-line readout in the second half of the year is quite exciting and how it will cover the TD96 potential of the combination. Clearly, we've done mamelotinib, I think, to build on Hal's answer earlier. It's not just a refractory population. There is a first-line subgroup who are indicated for ruxolitinib but are precluded from that by NCCN guidelines because of the hemoglobin level. That's a natural group that ruxolitinib and frutatinib are challenged by. And if you look at the mechanisms which are being explored, they're really designed to drive efficacy in that first line rather than address the underlying anemia, which we know from the market research is highly concerning for physicians. So that's why we see the opportunity there at first and second line for mamalotinib. And then finally with Blenrat, I mean, we've said this on a couple of earnings calls, we've got to do a couple of things. We need to expand usage in the community. um you know it's dominated by the academic center even though only about a third of the volumes there and to do that ultimately through partnering with how's organization we need to resolve the keratopathy rates that we see through a combination of dosing level sequencing and combinations which how the team are working on so how i'll hand over to you for that part yeah thanks and just briefly just to comment on the pipeline as you know a little less than four years ago in 2018 when we made the commitment to specialty medicines

highlighting that oncology is an ideal area to get back into given its potential. We made a lot of progress. I think at that time we had a handful of things in the pipeline. The most advanced was in phase one. Now we have three approved drugs, hopefully a fourth one soon with them allotted. Just to briefly comment, our focus has been within oncology on immuno-oncology and synthetic lethality of the immuno-oncology. We now with the PV rig entering the clinic this month, We have that, CD96, TIGIT, and Dostarlimab, four reagents that we think will combine very interestingly on the CD226 axis to potentially usher in this new era of immuno-oncology that is very exciting. Obviously, we have other reagents that are both in preclinical and in the clinic that will complement all four of those. In synthetic lethality, as Luke mentioned, Sejula, fantastic drug with the Prima data, really augmented by the XyLABS prime data, really very encouraging, reinforcing its unique best-in-class characteristics. We have some lifecycle management going there. In synthetic lethality, we also have a very robust pipeline in research, and one in the clinic, the SMAT2A inhibitor that we're doing with IDeA for NTAP-deleted tumors, so really terrific progress. I won't say more about Memmalotinib, but getting back to BCMA, really pleased with its approval. excitement in the clinic in the fourth and latter lines. We have the DREAM-3 study that we'll read out in earlier lines, DREAM-7 and 8, that is exploring whether it could be actually superior to Velcade and Darzalex in two different studies, leveraging extending dosing intervals, altering the holding patterns, and looking for synergy with pomalidomide in studies like Algonquin, where we saw some pretty significant response rates of greater than 90% when given with POMDEX. And that combined with, as you put in your question, the idea of using gamma secretase inhibition to increase expression of BCMA on the plasma cells to further optimize the regimen by reducing the dose, which hopefully will maintain efficacy and potentially reduce ocular toxin. We're going to have some preliminary data shared at ASCO with more advanced and mature data later in the year.

Thanks, Hal. We are going to, because I know there are still a lot of questions waiting through, so we're going to run to 1.15, but let's take the next question first.

Great. Thank you. And just as a kind reminder, please note to keep the number of your questions to one. And the next question is coming from the line of Tim Anderson for Fee Research.

Thank you. A couple of questions, please. On Shingrick's At maturity, so years down the road, I'm wondering how you expect sales will split out between U.S. and the rest of the world. If I look at a product like Prevnar, it's about 50-50 U.S. If I look at Gardasil, it's only one-third U.S., X-U.S. is two-thirds, so that's quite different. So I'm wondering what Shingrix will look like years down the road from now, more like a Prevnar or a Gardasil or something else. And second question is on Atilamab, updated level of confidence in the upcoming readout and commercial opportunity. Last time Hal talked about the program, I think at Q4, quite bullish, but today went through key readouts on slide seven. It was not part of prepared remarks, despite being phase three. And I'm wondering if you can tell us how you're thinking about that product.

Great. Well, let's come to Hal first on that. I wasn't reading everything on the slide. And then perhaps Luke, you can comment on the profile of Shingrix. The geographic expansion has been and will continue to be a key contributor, but some additional comments from you on that would be good. But Hal first on OT.

Yeah. Tim, thanks for the question. Let me try to answer that. I think that when you look at OT, it's really part of a package with CCL17. What we stated in 2.4 and I think remain confident is that in rheumatoid arthritis, although there are a number of different therapies, the biggest unmet medical need in rheumatoid arthritis patients is the reduction in pain, which results in a pretty significant number of patients switching drugs or looking for new opportunities. That combined with the increasing safety concerns with some of the other reagents out there, we think represents an opportunity. Motilumab is a unique mechanism. It's important to remember that the Phase IIb actually failed to meet its primary endpoint, but we did see encouraging trends in some of the endpoints that we think are clinically meaningful that relate to symptoms that patients have like pain. And so that's why we moved that forward. But I think when you think about the fact that the pain signal seemed to be a little bit out of proportion to the anti-inflammatory effects that when you inhibit gene CSF, when you look at what the transcription profile looks like when you do that in the monocyte, one of the strongest signals we get is the CCL17 protein level changes. And those two things combined enabled us to both move forward in phase three, but also initiated a program with the antibodies of CCL17, which is finished its phase 1B randomized section for osteoarthritis pain. And so we're thinking of that as a package, and we should have data by the end of the year. And, you know, we're hoping that there will be a new opportunity for patients to have their pain reduced by some pathways in GM-CSF or CSCL17. More data later this year.

Thanks, Al. Luke?

Thanks, Tim. Initially, Prevdar-like, I mean, I think the US is going to continue to be very dominant. I mean, we've gone from 18% this time last year to about 30% ex-US, but there's still a large volume of patients that we can dose in the US. If you go more than five years out, it starts to look more like HPV, as you see markets like China and Brazil and the larger emerging markets pick up. And that's through a stage. Initially, it's very much an out-of-pocket or a concentrated immunocompromised reimbursed population. And as we get further out in the plan, we'll switch to a combination of volume and tendering. Clearly, we're watching very closely Pfizer and Moderna. And our aim is by the time that they reach the market in 2026, we would have got the bulk of the U.S. and European patients vaccinated. And you know the efficacy profile of this product is quite striking at eight years plus. So that's how it will look. It just depends on the time point that you assess the distribution between the U.S. and the rest of the world.

Thank you. Next question, please. The next question is coming from the line of Kelly Holford from Exane. Please go ahead.

Hi there. From Berenberg, actually. Two questions, please. Firstly, on M&A, following the recent CRR, I'm just interested to hear what appetite capacity you now have for further M&A partnerships, particularly in the context of lower valuations out there in the market and tough IPO conditions. And also, in the context of that, can we expect you to continue to focus on oncology or are you still looking across other therapeutic areas? And then finally, just a quick follow-up on RSV. When that Phase 3 study is complete, Can we expect you to provide efficacy detail within a press release, or might you just message at a very high level, it worked, it didn't work? Thank you.

Thanks. Well, first of all, on BD, we have both appetite and capacity. I think we've been extremely consistent in emphasizing that our number one priority continues to be the strengthening and the execution of the pipeline, that we expect to complement that. with business development, as well as driving forward our organic portfolio. Obviously delighted with the latest news on Sierra. To take a step back, this is across our vaccines and specialty portfolio. We want to pursue things that are in line with our strategy, in line with our key therapy areas, and obviously with due financial discipline, depending on the stage of it, whether that's IR, MPV, or So a lot of focus there. I mean, just, you know, if you think about it, even in the first quarter, obviously we've made some moves in oncology, but, you know, in this quarter we contributed 1.3 billion from the business development partnership with VEA. Um, we went into the clinic actually with our to cure back, uh, unmodified, uh, assets, both on flu and on coven and we'll come in later with the others. And we've seen all the progress we're making on 2 drug regimens and super excited. Hopefully later in the year to see some 1st data out on the combos with. So, yes, we will continue to do more. including in sort of structured partnerships. And that obviously is one of the benefits, the strategic benefits of the deep merger is the continued strengthening of our balance sheets to do so, but with all due discipline. Hal, is there anything that you want to comment on in terms of data plans when the results come in on RSV?

um well i mean um you know we're looking forward to completing the study and getting the data interpreting the data and um you know ideally sharing the data externally um you know the headline data like we typically do but it's often a case-by-case basis and and we're going to have to take a look at all that before deciding exactly what goes in press release typically thanks next question please

The next question is coming from the line of Peter Welford from Jefferies. Please go ahead, sir.

Hi, thanks. Two fairly quick ones. First, just on osteoarthritis, sorry, ulcerative RSV, rather. Just again, just following up on the timing of the data, given what we see with the RSV cases, which are now significantly coming down to almost zero, I think, in both Europe and the U.S., Can you just come back? Have you got all the events you need for the analysis already and now it's just a case of analysis? Or are you still actually waiting for some of the events to occur? And I guess how should we think about in regards to your confidence then of getting the readout into Q? And then just one, which I think is probably more consumer than anything else, but just regards to Russia and Ukraine. There was a comment about there were some provisions taken in the quarter. Can you just talk, what was the impact, if any, on the consumer margin? I guess I'm thinking, was that a factor that we should consider actually that was potentially a negative on the margin this quarter? And given, I think the consumer business is more extensively exposed to Russia than perhaps Glaxo is. And perhaps you could just talk a little bit about cash collection as well, please, in Russia particularly, and whether or not you've had to take or have seen any decreases in the ability to get cash collection at all so far. Thank you.

Great, thanks. Well, lots of detail in the questions on Russia, which I'll ask Ian to cover. I mean, it's one for the group and slightly more for consumer than GSK, but I wouldn't make that too wide a difference. And Ian will comment on that. Hal, just anything to add at all on the older adult trial?

No, of course, these are, as you know, these are event-driven analyses, but we remain on track, as we've said to Rita, by the end of Q2.

Right, thanks. Ian?

Yeah, thanks, Emma. Thanks for the question, Peter. So on Russia, for GSK, if you like, BioPharm and UGSK, Less than 1% revenues, less than 1% adjusted operating profit. In terms of provisions in the quarter, consequently, you can imagine that they bear no relevance from a materiality perspective. The vast majority of our receivables in Russia are insured and subject absolutely to our compliance with any sanctions. At least the willingness to continue to pay the bills is coming through clearly from customers whilst recognizing that the continued reshaping and prioritization of the businesses, both from a biopharma and from a consumer healthcare perspective. And the data that I've shared and the facts I've shared is equally true across both consumer and GSK. So at this stage in the proceedings, well covered from an insurance perspective, willingness of customers to the extent they can pay with clear compliance with sanctions still very, very clear. And to the extent that we've taken provisions in the quarter, they are not material either for GSK or for Halien.

Thank you. Next question, please.

The next question is coming from Ian Simpson from Barclays. Please go ahead, sir.

Thank you very much. A couple of questions from me, if I may. I mean, I understand that you're, you know, you've made the point about tough comps in the second half of this year. But if I look back to the performance in 2020 and try and think about the two-year stack and where you sit versus pre-pandemic levels, the comps aren't all that tough. They're a couple of percent tougher maybe for the full year versus the Q1. And you've clearly had a very strong Q1 print. So I'm just trying to think about your guidance of being sort of between 4% and 6% for the full year. Is there an element of you just wanting to be conservative there given how limited visibility is and how much we've seen things change globally in the last few months and then my second question when I think about your margin again clearly a strong start to the year but how should I think about the phasing of that standalone cost building as we go through the year you've said you've done some systems transfer but at what point does that standalone cost really start to kick in thank you very much

Great. Well, both questions for Brian. Just as a reminder, it is only Q1 in terms of outlook for the year from our perspective. But Brian, do you want to comment?

Yeah, absolutely. Thanks, Ian. And again, I just want to reinforce, I do feel very good about our start of the year and the performance, given the organic sales growth, pretty broad base across category regions and across power brands. I've talked about the 2% forward buy and the impact of cold and flu. It's early in the year, and we are managing through a very uncertain geopolitical and macroeconomic environment. So, you know, like I said, I'm very confident in our 4% to 6% guidance for the year, but at this point, I think it would be premature to say anything else. On your comps, it is quarter by quarter, can be up and down, as we know. If you think, you know, two years ago in Q1, we were at 14% last year, minus 9% this year, plus 16%. And that's a bit of the up and down and cold and flu and the forward buys. And we look at the back half, you know, we know in Q4 is we had a cold and flu season that was similar to what we're seeing in Q1 of this year. And that's where my comment on the comps really come from. On the margin, again, strong start to the year and feel good about how we've been able to navigate a very tough economic environment. But as I said, the $175 to $200 million of cost to run, Halion is an independent company, aren't fully ramped up. They're getting more ramped up in Q2, and then as we become an independent company, you'd expect us to be pretty much fully in place. But as we think about the back half, And, again, nothing's changed from the building blocks we shared at Capital Markets Day for 2022 or in the medium-term guidance of moderate margin expansion.

Fantastic. So, obviously, we're all looking forward to the next steps in the deployment ahead of the demo. Next question, please. I think we have time for one more.

The question is coming from the line of Mark Purcell from Morgan Stanley. Please go ahead, sir.

Yeah, thanks very much. Just going back to two topics. Firstly, on RSV, can you help us understand what would be considered a positive readout from the ERA6 trial? J&J have set a benchmark, I guess, with the Cyprus data. So is that what we should be thinking about? Otherwise, what sort of benchmark should we be thinking about? And then sort of secondly, on Shingrix, you know, in follow-up to Tim's question, where are we at the moment in Germany relative to the U.S. in terms of uptake? And how should we think about the progress of other ex-US countries compared to Germany maybe using that as a proxy? Luke, you talked to how you felt that you captured the European market in five years. So just trying to understand the progress there and where we are with upgrades, such as the liquid formulation and looking at trials in immunocompromised adults above 18 years of age as well to build the market further.

Okay, great. So, Hal, to you first, please, just quickly on... RSV trial data, and then Luke, over to you, please.

Yeah, thanks, Mike, for the question. You know, as we've said previously, it's both hard to predict efficacy and it's hard to predict efficacy relative to competitors without any data. But as we look at our own immunogenicity data, the, you know, aggregate packages that have been presented by other companies, I think we have, and I should say, and in discussions with clinicians, we're pretty confident that effects that are more than 50% are are probably clinically meaningful. An effect greater than 70% is a very good response. And it'll be, we think, a very successful vaccine. And should we get efficacy above 80, that's truly outstanding.

Right. Luke? Sure. So, Mark, I mean, if you look at Germany, it's about 133 of the 160. I mean, we're at early stages with Germany. I think what's attractive about Germany is you've got heavy levels of support from the SIC funds, so there's not a high out-of-pocket exposure. Now, that varies across the rest of Europe. Some countries have concentrated on the immunocompromised for reimbursement. Other countries have got a cutoff in terms of age. So it's going to be more staged with those markets. And then if you look beyond Europe, we've seen a good uptake in Canada. We're just starting to get going in Australia. We'll launch in Brazil later this year, and markets like Saudi we expect to pick up. Again, the strategy is in the initial out-of-pocket segment at a consistent price globally, and then we'll go to tiers and tenders later in the lifecycle of the product. So very much starting out. And then China, finally. It's very much on hold right now because all vaccinations in China have to be carried through points of vaccinations which are run by the government. And of course, right now, they're heavily focused on COVID vaccines as well as the restrictions that people have in China right now.

Right. Thanks. And one last question, please. Feel free on HRV.

And our last question is coming from the line of Simon Baker from Redburn. Please go ahead, sir.

Thank you very much for squeezing me in. Two questions. Firstly, one for Brian on oral health. It's an important driver because historically it's grown above the four to six growth rate that you've been targeting. So I just wonder if you could provide us with some colour on how the market's evolving and your share within it and any innovations you're pursuing within Sensodyne to continue that growth. And then a question for Hal, touching on something you mentioned. You talked about to Stalimab. at CD96 antagonists in TIGIT. And you do have a phase one study trying those in triple combination, which I saw was expanded and delayed last week. The trial's been expanded. It's been pushed out about 18 months to August 2024. So any colour you could give us on the reason for the expansion and the delay would be great. Thanks so much.

Thanks. Right, well, so Hal, let's come first to you, and then we can fittingly finish with the question and answer to you.

Well, thanks for the question. We're very excited about our immuno-oncology portfolio. We think the CD226 axis highlighted by TIGIT, but also complemented by CD96. And as I mentioned earlier, the addition of PVRIG is an exciting opportunity for GSK to be leaders in this new area of immuno-oncology should it end up being successful. You know, the programs are challenging to develop both TIGIT monotherapy, TIGIT combination, identifying doses for both of those, adding in CD96 with distalimab, adding CD96 with a triplet. So these studies are all quite complicated to find doses and whatnot. So the expansion of the trials are really to highlight the ability to find the right dose, make sure they're safe, and look for efficacy signals. And we're doing that across different tumor types. So it's a very robust program, but we're going to have to enroll a number of patients before we get the answers to the triplet combination.

Thanks. And Brian on oral health?

Yep. Thanks for the question. So first of all, really good performance in oral health in Q1. We grew 9% versus a year ago. And it was really strength across all of our three main brands. High single-digit growth on Sensodyne, double-digit growth on Paradontax, double-digit growth on Denture Care, which has a bit of a rebound from softer consumption during the pandemic. Importantly, we grew share on all three of those brands on a global basis. From an innovation perspective, we launched Sensodyne Nourish in the U.S. and are beginning to roll that out. Sensodyne Nourish is still providing the sensitivity benefits, but also has herbal ingredients. It's in recycled toothpaste tubes and packaging and and is attracting a younger consumer base into the franchise. Early days, but we're encouraged by where that will take us. So, you know, feel very good about our oral care franchise and the way the year started.

Great. So, thank you, everybody, for the call. Obviously, a strong start to this landmark year for CSK, and we're now very excited to be in the final stages of the plan to demerge consumer. and create two companies with new chapters for growth. It's wonderful to see good momentum across the business, recognizing phasing patterns, the underlying strength is very much there, and we remain all extremely focused on maximizing shareholder value, patient impact, and building businesses with people that can thrive. Thank you very much. We look forward to speaking to you all soon and in coming days and weeks.