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

Hello everyone, it's Nick as mentioned. Welcome to our first half in Q2 2022 conference call and welcome to our investors and analysts. This is our first quarter as a new biopharma company and earlier today the presentation was posted to gfk.com. It was also sent by email to our distribution list. 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. As a reminder, GSK satisfied the formal criteria according to IFRS 5 for treating consumer healthcare as a discontinued operation effective from 30th of June 2022. The consumer healthcare business was demerged on 18th of July to form Halion, and as a result, we're presenting continuing operations for GSK. Earlier today, Halion also published a trading update and will be announcing its Q2 results in September. Please turn to slide three. This is today's agenda, where we plan to cover all aspects of a half year in Q2 2022 results. The presentation will last at least 35 minutes, with a further 40 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 one question so that everyone has a chance to participate. We can always come back for a second round. Today, our speakers are Emma Wormsley, Hal Barron, Luke Miles, Deborah Waterhouse, and Dean McKay. The Q&A portion of the call will be joined by Roger Connor and David Redfern. Turning to slide four, I'll now hand the call over to Emma.

Thanks, Nick. And a warm hello to everybody joining our half-year and Q2 conference call today. Please turn to the next slide. I'm pleased with the momentum. We're delivering a landmark year, the most significant corporate change for GSK in 20 years, and a new chapter of competitive and profitable growth. GSK is now a focused global biopharma company with the ambition and purpose to unite science, technology, and talent to get ahead of disease together. It's a company focused on the science of the immune system, human genetics, and advanced technologies. with world-leading capabilities in vaccines and medicines development across four therapeutic areas. In delivering our strategy, we have made and will continue to make significant improvements in both R&D productivity and operating performance, unlocking the potential of GSK. Our bold ambitions are reflected in commitments to growth and a significant step change in delivery. Through the demerger, we've also strengthened our balance sheet, creating new flexibility to invest in sustaining growth and innovation. These bold strategic steps enable us to deliver for patients, shareholders, and our people on our five-year ambitions and beyond. I'm delighted by today's first half results. They demonstrate that our strategy is delivering the step change in performance we committed to, with double digit sales growth of 25%, adjusted operating profit growth of 26%, and adjusted EPS growth of 27%. This performance supports my strong confidence in our medium term outlooks. The first half sales growth was driven by strong commercial execution across the whole portfolio. And alongside this excellent performance, we continue to invest in R&D with further strategic business development to support our pipeline momentum. Given our momentum and these very encouraging results, we're increasing our full year guidance, excluding COVID solutions, to between 6% to 8% sales growth and 13% to 15% adjusted operating profit growth. Please turn to slide seven. Q2 was another strong quarter of growth. Sales increased 13% to £6.9 billion, adjusted operating profit grew 7% to more than £2 billion, an increase of 21% excluding COVID solutions, and adjusted EPS grew 6% to 34.7 pence. Specialty medicines grew 35% to £2.7 billion, benefiting from strong demand for Devato and Cabinuva in HIV. Excluding Zavudi, sales increased 13%. Vaccine sales grew 3% to 1.7 billion pounds, driven primarily by Shingrix, which delivered another quarter of record growth, with sales more than doubling to 731 million pounds. And excluding pandemic vaccines, sales grew 24%. And general medicines also increased 2% to 2.5 billion pounds, reflecting the strong growth of Trilogy in respiratory. In SG&A, we continued disciplined cost control while prioritizing investments in growth to support launches in specialty medicines and vaccines, particularly Shingrix, as we accelerate international expansion and invest for further growth. In R&D, we increased investment in specialty medicines to support our early-stage HIV portfolio while also investing in our late-stage vaccine portfolio and mRNA tech platforms. You'll hear more about our commercial and financial performance from Luke, Deborah and Ian in just a moment. Turning to slide eight and our pipeline headlines. Our focus on the science of the immune system, human genetics and advanced technologies is reflected in the excellent progress and strength of our late stage pipeline. We were the first to announce positive phase three results with our RSV vaccine candidate in older adults, demonstrating statistically significant and clinically meaningful efficacy and exceptional protection. We also announced encouraging Phase IIb data for bepiriviracin and chronic hep B. This is a disease with a very significant unmet medical need and is responsible for over 900,000 deaths each year. In a moment, I will provide more details on these and our broader pipeline momentum. This quarter, we also completed the acquisition of Sierra Oncology and announced the proposed acquisition of Afinovax. Both of these transactions are excellent examples of strategic business development to develop a strong portfolio of innovative vaccines and specialty medicines that will deliver sustained growth through the decade and beyond. So this is an exciting year with strong momentum. I'm pleased with the progress we're delivering. And now, over to the team. Hal, first to you on slide nine.

Thank you, Emma. Next slide, please. I will take the next few minutes to review the recent progress in our pipeline and key expected news flows over the next 12 to 18 months. This slide updates one that we presented in June 2021. At this event, we highlighted that based on assets launched between 2017 and 2021, our R&D performance was top quartile relative to industry peers. Furthermore, these launches are expected to contribute over 60% of the 2021 to 2026 sales category for GSK. In addition, the balance of the sales growth on a risk-adjusted basis is expected to come from anticipated approvals for medicines and vaccines in the pipeline. As you can see here, I'm pleased to say we've made tremendous progress against these commitments. Based on the robust results of the Ascend Phase 3 program, we completed both U.S. and EU regulatory submissions for Deprotostat in the first half of 2022, and we now look forward to a decision from the FDA by February 2023. During the first half of this year, we also received approval for Aperture, the first the world's first long-acting injectable for the prevention of HIV. The biggest news from our pipeline, of course, was the exceptional phase three data we announced last month from our RSV vaccine trial for older adults, which Emma just mentioned. We also presented impressive data for bepi reversin, which I'm going to call bepi from now on, in the treatment of hep B. I'll touch on both of these assets later. Looking ahead, we remain on track to report pivotal data for several assets on this list with several potentially important readouts in the second half of this year. Importantly, as you know, we've been very active on the business development front, augmenting our pipeline with two important deals. First, the acquisition of Sierra Oncology, which includes Momolatinib, a potential new treatment for symptomatic myelofibrosis patients with anemia. Our proposed acquisition of Affinovax will provide us with a next-generation 24-valent pneumococcal vaccine candidate, as well as access to an innovative MAPS technology, which may generate vaccine candidates with higher valency and higher immunogenicity compared to existing options. Finally, I wanted to mention our early-stage pipeline activity. We've initiated 10 phase 1 slash 2 studies in the first half of 2022 alone, including our PV rig antibody in oncology and a capsid inhibitors in HIV. Importantly, I'm also pleased to report that interim data from our phase 1B randomized control study of anti-CCL17 and osteoarthritis was positive, demonstrating reduction in knee pain intensity compared to placebo at the end of the eight-week dosing period. We're proceeding with discussions with regulators to inform our future development of these Now please turn to slide 11. In June we were excited to announce positive pivotal phase three data for our RSV vaccine candidate for older adults. RSV remains one of the few major infectious diseases without a vaccine and RSV infections are associated with around 360,000 hospitalizations and over 24,000 deaths worldwide each year. Our vaccine candidate contains a pre-fusion RSVF glycoprotein antigen combined with our proprietary ASL1 adjuvant. The adjuvant was designed to address the natural decline in the immune system linked with aging, and the vaccine is the first to report statistically significant and clinically meaningful efficacy in a Phase III trial. Importantly, the magnitude of effect observed in this trial was consistent across both RSV-A and RSV-B strains and across key secondary endpoints, including people aged over 70, in patients with comorbidities, and in the prevention of severe respiratory disease. The trial will continue to generate data for three years following a single and annual revaccination schedule. We look forward to sharing these exceptional data with regulators in the second half of this year. We believe this puts our RSV older adult vaccine candidate on track to be considered at the June 2023 ACIP meeting. Slide 12, please. Last month, we were also excited to present interim end-of-treatment data from the 457-patient BEPI monotherapy trial, Be Clear, at the Easel International Liver Congress. The current standard of care for hep B patients includes antiviral plus interferon therapy, Existing treatments rarely result in a functional cure, and as a result, hepatitis B remains a significant unmet medical need with 300 million people worldwide living with hep B, which is responsible for approximately 900,000 deaths each year. Our ambition is to develop a functional cure for patients with hep B, eliminating the need for prolonged therapy, and by doing so, reducing the long-term risk of developing cirrhosis and liver cancer. The data presented at EASL demonstrated that BEPI was effective in lowering hepatitis B surface antigen below the lowered limit of quantification. This is the first time that any monotherapy agent has been shown to reduce hep B surface antigen below the lower limit of quantification in more than a handful of patients. What appears to be driving this unique effect is BEPI's novel mechanism of action. As described in a poster at EASL, in addition to lowering HPV surface antigen, VEPI appears to uniquely activate the TLRA pathway in the liver. This activation appears to stimulate an immune response which helps clear the virus, which we hope will result in functional cure for some of these patients. We will continue to monitor the patients in the Be Clear study to assess the durability of this remarkable response, and we expect to present these data later in the year. However, based on the strength of the Be Clear data set to date, we plan to initiate a phase three monotherapy program in 2023. Additionally, we expect to report the data on the B-Together trial, which looks at BEPI followed by PEG interferon. While interferon has a well-known tolerability burden, we are cautiously optimistic that this study will augment the data seen in the monotherapy setting. Turning to slide 13, this year's ASCO meeting saw an increased cadence of presentations on our growing oncology pipeline, including data from six potential new medicines within our portfolio. In particular, I want to highlight the pivotal data momentum from mamelotinib, the groundbreaking data from gemperlian rectal cancer, and the first publication of data from our BlendRep plus GSA combination study, DREAM-5. I want to briefly review the latter two data sets on the next slide. While BlendRep continues to deliver strong activity as a single agent, we're investigating how to advance this important medicine into earlier lines of therapy using different dosing schedules and scans. The GSI combination is one potential solution because it may allow a marked reduction in Blender-up dose while maintaining a similar efficacy rate. This in turn brings the potential for reduced ocular toxicity. We were therefore pleased to share the preliminary data from the GSI combination cohort of the DREAM-5 sub-study at ASCO. This showed encouraging signs of activity with an overall response rate of 38%, similar to that of the DREAM-2 study, but with lower rates of ocular adverse events and only 7% of patients reporting a grade 3 ERWERS ocular event. Subsequently, at IHA, data were presented by Terpos et al. in the frontline setting using an eight-week dosing schedule with lower doses of Blenrep. This regimen resulted in a very high response rate with much lower rates of ocular side effects than has been seen with a standard three-week dosing schedule. I also wanted to briefly mention the extraordinary trial with gemperli or distalimab. and patients with DMMR locally advanced rectal cancer in the neoadjuvant setting. This trial, which is awarded the coveted best of ASCO data, showed an unparalleled response rate with each of the first 14 trial participants who completed six months of therapy reporting a clinical complete response. These data suggest the potential for a chemotherapy-free treatment with curative intent for this difficult-to-treat population, and we look forward to working with regulars to identify a path forward for registrations. Please turn to slide 15. My final slide lists a number of the key clinical and regulatory events expected over the next 12 to 18 months. As I noted, we'll see data from across the portfolio with pivotal results anticipated for Otilamab and our vaccine candidate, MEN-ABCWY. In addition, we hope to see data from Blenrep in third-line multiple myeloma patients and potentially an interim analysis for Gepatitis N for the treatment of patients with uncomplicated urinary tract infections. We also anticipate data from the head-to-head PERLA study, which looks at gemperli plus chemo versus pembrolizumab plus chemo in the treatment of patients with non-small cell lung cancer. The PERLA study is not intended for registration, but will inform future development plans for our PD-1 antagonist. Finally, this is my last quarter presenting our R&D progress, so let me close by saying how delighted and proud I am of the achievements of the R&D organization since I joined in 2018. We've made considerable progress against our objectives to improve productivity in the pipeline and embed significant cultural change across R&D. Assets within our development pipeline are now supported by genetic data, which we believe will increase the probability of success. And we expect to accelerate the cadence of new product introductions. I'm also incredibly proud of and confident that my successor, Tony Wood, will build on these achievements and further accelerate our R&D delivery. Tony is an outstanding scientist and an inspiring leader, and I look forward to contributing to the next chapter of growth for GSK as a non-executive director. With that, I'll now hand it over to Luke.

Thanks, Hal, and I'll miss saying that. Please turn to slide 17. So I'm pleased to say vaccine's performance was very strong, with sales growth of 24%, excluding the impact of the prior year pandemic vaccine sales. The continued recovery of Shingrix, where we delivered another record quarter of turnover. The strong Shingrix performance reflected good demand and a focused commercial effort in the US to extend shingles vaccination throughout the year, which led to steadier TRX volumes in half one, higher engagement in non-retail settings, and an earlier than anticipated channel inventory build. In Europe, we continue to see strong demand in Germany and contributions from new launch markets as Shingrix becomes more widely available. Shingwix is now in 23 countries globally, and we are unconstrained on supply and remain on track to expand to more than 35 countries by 2024, making Shingwix available in around 90% of the global vaccine market. We remain on track for a record year with strong double digit sales growth this year. Previously, we had expected sales to be weighted to the second half, but following the earlier than anticipated channel inventory build, we now expect slightly lower sales in half two than in half one, reflecting an anticipated one million doses of inventory burn. Shingrix is the key driver of this year's expected sales growth in vaccines, excluding pandemic solutions, and we now expect vaccine sales to grow by low to mid-teens, up from low teens previously. Please turn to slide 18. In Q2, specialty pharma business, including HIV, continued to deliver strong performance with 13% growth. Deborah will cover HIV momentarily. This excludes the pandemic solution sales contributions from Zavuti, which delivered an additional £466 million during the quarter. Ben Lister delivered another quarter of double-digit growth. Our market-leading lupus medicine in the U.S. is also benefiting from increased contributions from China, Japan, and the European markets driven by our expanded indication for lupus nephritis. For NUCALA, our IL-5 biologic, which is broad, has a broad and differentiated indication approved across our four eosinophilic diseases, delivered strong growth as it remains the leading IL-5 in key markets like the US, Japan, and the EU5. And our leadership in the IL-5 space is underscored by our lifecycle innovation commitments with phase three trials for NUCALA and COPD, and our long-acting IL-5 depomocumab ongoing. In oncology, Sales increased 23% as we're seeing signs in the US of ovarian cancer and surgery rates stabilising. We're well positioned as the market recovers with half of the new first-line ovarian cancer maintenance patients receiving Zejula. And finally, I'd also like to point out that our Gen Meds portfolio delivered a fifth consecutive quarter of growth, up 2% in Q2, with strong growth from Trilogy across all regions, which more than offset the decline of older established products in the quarter. Trilogy is the number one triple therapy in COPD and asthma in the U.S. with market shares above 50% in each. And I'll now pass to Deborah on slide 19 to review the performance of HIV.

Thanks, Luke. Our Q2 performance demonstrates a progressive acceleration of growth underpinned by our oral two-drug regimen Devato and our Cabotegravir-based long-acting injectables for the treatment and prevention of HIV. Each of these sales were £1.4 billion, with growth of 7% in the quarter and 10% in the first half. Performance benefited from strong patient demand for our innovation portfolio, which comprises Devato, Cabinuva, Jaluka, Recobia and Apertude, and a favourable US pricing mix. This was partially offset by the unfavourable phasing of Tivicay tenders. Momentum is firmly behind our innovation portfolio, which delivered more than £1 billion in the first half of the year and now accounts for 41% of our sales. Our ambition for the year is to deliver mid to high single digit sales growth. Our business delivered strong growth in the US and in Europe, growing at 13% and 17% respectively. This growth was underpinned by strong commercial execution across the portfolio. Dovato continues to perform, delivering £320 million of sales in the quarter, which represents 66% year-on-year growth. Market performance firmly reflects prescriber belief, and we were delighted to see that through this quarter, Dovato reached the milestone of £1 billion of rolling annual sales, with further significant growth potential beyond. Performance in Europe is particularly strong, with market share for Devato at around 13% and the leading position in Switch. Turning to our injectable portfolio, Cabinuva, also known as Vocabria or Cambus in Europe, is the worst-in-class long-acting treatment regimen for HIV. Sales almost dropped in the quarter, delivering £72 million. 11,000 patients are now taking Cabinuva, an increase of 5,000 through this quarter, and around 1,200 HCPs are prescribing the medicine. The approval and launch of the every two-month dosing in the U.S. in February and the removal of the oral leading requirement in the U.S. has simplified and improved patient experience and delivered a significant inflection for this injectable therapy. Underlying patient demand is high, And we are therefore very confident about the potential of this medicine to transform the treatment paradigm of HIV. Moving on to prevention, Apertude is the world's first long-acting injectable for the prevention of HIV, dosed every two months. It was launched in the US in January 2022. This quarter, we received the J-code for Apertude, which is an important step as it enables prescribers to buy and bill and simplifies reimbursement for the medicine. With around 1,700 patients already taking Apertuge in the US, we have high levels of ambition for this medicine and launch activity continues to center on building awareness and access. I'm pleased with the progress we have made in negotiations with the medicine patent pool to enable access to CAB LA for prevention in resource-poor settings. We look forward to providing further updates at the International AIDS Conference which is taking place in Montreal in a few days' time. I will now hand over to Ian. Next slide, please.

Thanks, Deborah. As I cover the financials, references to growth are at constant exchange rates unless stated otherwise. Turning to slide 21. Firstly, this presentation is based on the continuing operations of GSK, as Nick noted earlier. For the second quarter of 2022, commercial operations turnover was £6.9 billion, up 13%, and adjusted operating profit was £2 billion, up 7%. Total earnings per share were 17.5 pence, down 58%, while adjusted earnings per share were 34.7 pence, up 6%. The main adjusting items of note between total and adjusted results for Q2 were in transaction related, which primarily reflected the Veeve contingent consideration liability movement, the majority of which related to foreign exchange, and in other which reflected an unfavorable comparison of a £325 million credit in Q2 of 2021 resulting from the devaluation of deferred tax assets following the enactment of the proposed change in UK corporation tax from 19% to 25%. Pandemic solutions reduced growth of adjusted operating profit by approximately 14 points and growth of adjusted EPS by around 18 points. The Q2 currency impact was a favorable 6% in sales and 17% in adjusted earnings per share. Please turn to slide 22. My comments from here onwards are on adjusted results and less stated otherwise. Global sales growth was 13% driven by strong performance across commercial operations as all product areas benefited from increased demand. Excluding pandemic-related sales, growth was 10%. Luke and Deborah have taken you through the commercial performance in the quarter and the key turnover dynamics. and I'll make comments on sales outlook shortly. Turning to slide 23. The second quarter margin of 29% was slightly higher as the margin benefited from operating leverage driven by strong sales growth, product mix excluding Zabudi, higher royalty income, and favorable currency movements, which were a 2.4 percentage point benefit in the second quarter. These factors were partly offset by the impact of lower margin sales of Zabudi, COVID solutions reduced adjusted operating profit growth by approximately 14 percentage points and reduced the adjusted operating margin by approximately 4.4 percentage points at constant exchange rates. Within the cost of goods sold, the increase primarily related to sales of lower margins of woody, which increased the cost of sales margin by 4.7 percentage points, mainly reflecting the profit share pay away to veer. Excluding the woody, were a 60 basis point benefit margin driven by favourable business mix with 61% of commercial operations sales ex-pandemic being from specialty medicines and vaccines compared to 57% in the second quarter of last year. This mixed benefit was partly offset by a modest increase in commodity prices and freight costs, which we can continue to manage closely. SG&A increased at a similar rate to sales in the quarter, which reflected an increased level of launch investment in specialty medicines and vaccines. This was particularly focused on HIV and Shinrix to drive post-pandemic demand recovery and support market expansion. The growth also included some increased freight and distribution costs. These factors were partly offset by continued delivery of restructuring benefits. Taking into account the commercial investment to date, we now expect SG&A to increase slightly above the rate of sales growth this year. R&D was broadly stable in the second quarter, which primarily reflected the ongoing benefit of efficiencies from the one R&D restructuring program, the benefit and the comparator with regards to the time of completion of several late stage programs, including COVID-19 investments in 2021. These factors were largely offset by increased investment in vaccines across mRNA technology platforms, ongoing late-stage trials, and the acceleration of several early-stage programs. There were also increases in early-stage HIV programs. In the remainder of the year, we would expect the R&D run rate to increase, in part reflecting phasing and in part reflecting incremental investment following the Sierra Oncology acquisition and anticipated at Finnavax deal. For the full year, given the dynamics we've seen in the first half, alongside our upgraded guidance for the full year sales growth, we now expect R&D to increase at a rate slightly below sales. Royalties benefited from the contribution of Victarvy and higher sales of Gardasil. In the first half, adjusted operating profit grew 26% to £4 billion, an operating margin of 28%, reflecting strong operating delivery. The commercial contribution of COVID solutions adjusted operating profit growth by around one percentage point. I'll cover the outlook in a moment. Turning to slide 24, moving to the bottom half of the P&L, I'd highlight that the effective tax rate of 15.2% reflected the timing of settlements with various tax authorities and higher non-controlling interest charges related to an increased allocation of V profits. On the next slide, I'll cover cash flow. In the first half, we generated £1.7 billion of free cash flow and cash generated from operations of £3.9 billion from continuing operations. The key drivers of higher free cash flow were as follows. A significant increase in operating profit, including the upfront income from the Gilead settlement in February, a favourable foreign exchange impact and favourable timing of collections and profit share payments for Zavudi sales. These factors were partly offset by lower proceeds from disposals, increased contingent consideration payments reflecting the Gilead settlement, higher capital expenditure, and a higher seasonal increase in inventory. Turning now to guidance on slide 26. GSK has delivered first half performance ahead of its existing full year guidance, as expected, based on strong business delivery and the dynamics of prior year comparators. As Emma outlined earlier, with that performance to date and the momentum it provides, we're raising our guidance for sales to increase between 6% to 8% and adjusted operating profit increase between 13% to 15%, excluding COVID solutions. For both sales and adjusted operating profit, we would expect Q3 growth below full year expectations given the stronger comparator of last year and a Q4 growth to be higher than Q3 given the more favourable comparator in 2021. With regards to phasing considerations for the year to go, there are several factors which will influence the outturn. These include sales delivery within the upgraded range, given the more challenging second half sales comparator. This includes the Shindrick stocking effect Luke covered earlier, as well as ongoing generic competition in general medicines. Product mix, phasing of R&D spend as we step up investments, strengthening our pipeline and technology platforms. Continued investment through SGA in supporting new launches and broader targeted business improvements, such as further investment in data and analytics. The continued risk from COVID dynamics as we head into the northern hemisphere autumn and winter seasons. And any possible developments in the current uncertain global macroeconomic environment. In terms of expectations for adjusted earnings per share, both including and excluding COVID solutions, we would expect growth around one percentage point below adjusted operating profits. reflecting lower associated profits, sorry, lower associate profits. On COVID-19 solutions specifically, the majority of expected sales for 2022 have been achieved in the first half of this year. Based on known binding agreements with governments, we expect that sales will be substantially lower in the second half. Compared with 2021, sales will be at a reduced profit contribution due to increased proportion of lower margins of woody sales. Given more than expected sales to date, we now expect this to reduce overall GSK adjusted operating profit growth by between four to six percentage points. With respect to dividends, dividends declared Q2 and those expected for the remainder of the year align with the existing expectations adjusted for the impact of the share consolidation completed on the 18th of July. Accordingly, GSK will pay 16.25 pence per share for Q2. For the second half, GSK expects to pay a 27.5 pence per share dividend, which is equivalent to 22 pence per share previously indicated before the share consolidation. For 2023, we expect to pay a 56.5 pence per share dividend. Turning to the balance sheet, with the demerger of hailing completed, we have now received the £7.1 billion demerger dividend and have our 13.5% retained stake in Halion that we intend to monetize in an orderly manner. This strengthened balance sheet supports our clear capital allocation priorities of further strengthening the pipeline, investing in new product launches, and delivering dividends to shareholders. Taking all this together, we remain firmly on track to deliver the step change in performance for 2022, first referenced at our investor update in June last year. And this sets us on the right trajectory for delivering our 2026 outlooks. With that, I'll turn it back to Emma.

Thanks, Ian. And turning to slide 28. At GSK, we're guided by our purpose to unite science, technology, and talent to get ahead of disease together. We deliver this purpose considering the environmental, social, and governance impacts across everything we do. Running a responsible business is integral to our strategy and future performance. It's how we build trust, deliver health impact at scale, and reduce risk. We prioritized our resources to focus on six material areas, the environment, global health and health security, diversity, equity, and inclusion, pricing access, product governance, and operating standards. We're focused on maintaining sector leadership in ESG with our number one ranking in the Dow Jones Sustainability Index and our longstanding leadership in the Access to Medicines Index. Looking ahead, we're also on track to deliver our ambitious environmental commitments with targets of net zero on carbon and net positive on nature by 2030. We're proud of our track record, but there is always more to do. And this quarter, we continue to advance our global health and health security leadership with a commitment to invest a billion pounds over 10 years to get ahead of infectious diseases in lower income countries. As part of this commitment, We also formed a new global health unit under Roger Connor's leadership, which will be measured by its human health impact. GSK is committed to delivering health impact at scale, reaching more than 2.5 billion people worldwide over the next 10 years. So in this landmark year, GSK has delivered another quarter of strong performance and momentum, and I am very confident that as a focused global biopharming company, we will deliver our bold ambitions for patients reflected in our commitments to growth and a step change in performance. With that, operator, can we please move to the Q&A for the team?

Absolutely. So everyone, your question and answer session will now begin. If you wish to ask a question, please press star and one on your phone. If you then decide to withdraw that question, simply key star and two. So just a quick reminder, if you wish to ask a question, key star and one. To withdraw that question, key star and two. Please make sure to ask one question only.

And if we have time, we are happy to take some additional questions. Thank you. And the first question is coming from the line of Emmanuel Papadakis from Barclays. Please go ahead.

Thanks for taking the question. It was once a Barclays, yeah, Deutsche Bank now. Hi, Manuel, hi. Hi, thanks for taking the question. So to one RSV, please, maybe a question around pricing strategies, to the extent you can help us there. We still don't know durability, of course, so I'd love to hear your latest perspectives on where you think that's likely to land. Presumably that's an important input in the pricing calculation. And give us some kind of yardstick, you know, between the boundaries of flu and shame works, what we should be thinking about and some of the considerations you're thinking of. Thank you.

Well, thanks, Manuel. But it won't surprise you to know that in a commercially competitive environment, we're not going to give very many indications around pricing. I'll let Luke add to this. But we are extremely excited about bringing forward further data on this. And there's just no debate, not in an environment for governments under the inflationary pressure they are, with the questions as they are, that prevention of disease is always a good investment for healthcare systems. And we're confident the payback for this, especially across multiple endpoints, will be a good one. I don't know if there's anything you want to add on.

I would just say you've got the bookends right, Manuel, but we can't give you whereabouts. It would sit between those two bookends, between flu and Shingrix.

Thank you. Next question, please.

Sorry. Can we just go back to the durability question and also any comments around efficacy health?

Well, I think, you know, we're going to be looking at the data to assess the durability. Of course, the reason that we, in part, used the ASO was to assess whether that would increase the durability both within a given season to see if the treatment effect is actually preserved during during what can sometimes be a long season, which could have really significant implications in terms of the timing of the vaccine, as well as the potential for being even super seasonal. And that's why we have the extended study where we're looking at additional vaccinations or annual. And I think in terms of the effect, what we've said, and I think is very clear, is it's exceptional data. And it's not just exceptional on the primary endpoint. What we said is this is a really exceptional data package, which includes both the effect on the primary endpoint as well as a myriad of secondary endpoints, including examining whether the effect was maintained in those over 70 versus those under, which it was, whether the effect was maintained in both the RSV-A as well as RSV-B, and it was. as well as the effect in patients with comorbidities and even reductions in severe disease. So overall, a very exceptional data package, and we look forward to being able to present that to the community soon.

Yeah, so lots more to come in due course. All right, next question, please.

Next, we have a question from Laura Sutcliffe from UBS. Please go ahead.

Hello, thank you. I've got a question on Shingrix, please. I know you've got a sales goal, doubling a sales goal through 2026, but do you have any sense of where the peak sales year sits for Shingrix? Thank you.

Thanks, Laura. I'll come to Luke in terms of overall outlook, but fantastic to see this momentum coming back. Record quarter will be a record year and a really important move, a bit back to this durability question on de-seasonalizing, if that's English. which is important as this move to more and more adult vaccination comes in. The opportunity for us and retailers is very interesting in that quarter smoothing. Amazing moves on geo-expansion. Luke, do you want to comment further?

Sure. I think, Laura, it's a great question. The main swing factor is probably China. You can imagine the US at some point will exhaust the population. Of course, our intent is to do that before any competitor would arrive, or largely do it before any competitor could arrive. We're learning a lot from the launches in Europe, and you can see that performance coming through in the results, which have just been reported. We're now launching in emerging markets. We just started in Brazil and a number of other smaller markets. The speed at which the uptake there will really guide that. But yeah, the main, because of the conditions on the ground in China right now, that's the main swing factor for us, even though the growth in absolute terms is quite strong.

Exactly. And again, this is why it's very exciting to see the pipeline building through in our adult vaccination portfolio. Shingrix with lots of great growth prospects ahead. And we'll add to that, hopefully in due course, the launch of RSV and of course the Afinovax portfolio later in the decade. Next question, please.

Next, we have a question from Kaya Parikh from Goldman Sachs. Your line is open now.

Hi, thank you. Hal, first of all, thank you very much for all your help and support over your multiple innings in the biopharma industry. I'm sure all of us really appreciate it. So good luck in your non-executive role, but thank you very much for the multiple years of help. A couple of questions, please. One, just a broad one on RSV. I know that Pfizer, at least as for clinical trials, seem to have recently changed the primary and the secondary endpoints on their RSV study. Wondering if you might be able to share your perspectives on what that means and why that might be the case. Linked with that kind of for Luke, from a commercial perspective, how should we think about the demand trends kind of when you launch the product? Should we think of this as a Shingrix-like kind of launch or is this one where you might have to kind of create a market unlike the situation with Zostavax and Merck? That's kind of on RSV. And then separately, as I look at kind of your updated guidance for the full year, at midpoint kind of for the operating profit growth range is essentially in price, kind of little to zero growth in the second half of the year. My question is not whether that's conservative or not, but if you're gonna exit the year doing kind of 0% growth in the second half of the year, how should we feel comfortable with double digit operating profit growth for 23 that you already guided to? Thank you.

Thanks, Kaya. I'll obviously come in turn to Hal, then Luke, and then Ian. You know we're not about to give you 23 guidance in Q2 of 22. And as Ian's alluded to, but I'm sure we'll add to that after we've heard a bit more on RSV, this is really a comparator question. We feel very good about the momentum on fundamental demand across the business. We feel very good about the outlooks overall on this five-year outlook we gave you last year. And we have always said that was not a back-weighted prospect. And we feel just that we've got all the fundamentals moving in the right direction, both on execution, on multiple core assets across the portfolio, and on the progress we're making in terms of the launches that are coming through. So, well, let's come to how, you know, frankly, we're very focused on our own results in RSV, and then we'll hear from Luke. The only thing I would say is the world has been waiting for 50 years for an RSV vaccine. I think the, so, you know, and usually when you have more than one competitor in a market, that bodes well for the size of the market, too. So we feel extremely excited about our results. But, Hal, I don't know if you want to make any or what you would like to say. Yeah, no, thank you.

Thank you for the kind comments, Cara. That's very nice. And I just want to say it's been a real honor to work in the field and particularly work as head of R&D at GSK with the incredibly amazing colleagues that I've gotten to spend the last four and a half years in, you know, transforming the R&D organization and really getting to this level. an incredible place we are at GSK today. So thank you for that. In terms of the Pfizer change, yes, of course, we saw that. It's a bit unusual, but I'm not going to comment on other companies' decisions on clinical trial design or regulatory involvement. I will say that, you know, we have exceptional results. This was a very unusual RSV season. But we do have exceptional results. We've seen the treatment effect, as I mentioned, maintained in both RSV A and B. And importantly, and this is I think very important, we specifically added the adjuvant because we, in phase two, observed, and this was somewhat known, but we observed that the elderly T cell response to viruses in general, and RSV in particular, are blunted and we were able to show that with this modified dose of adjuvant that we can normalize that T cell response and we did see in the clinical program a treatment effect in the over 70 to be very similar to that under 70. So, you know, as Emma said, it's always terrific when you have outstanding data. This has been in the makings for 60 years or so and it's very, very complicated. All of these scientific advances are now set to have a huge impact on the very, very large number of people whose, hopefully, lives we can save and certainly hospitalizations we can avoid.

Right. Luke?

So I think, Kaya, I mean, it's very interesting. I mean, there's been no solution to this problem. So you see high awareness amongst physicians because the numbers are quite striking, 6 million cases in the U.S., about 180,000 hospitalizations and on an average year, 14,000 deaths. So physicians are aware of it. In terms of people potentially impacted by it, not as great of awareness as you'd imagine because there is no solution, but I would expect that changes quite dramatically. So I don't think it's like Dostoevac's. I think it's going to be us creating the market. Now the question is, I think there's other variables. Is the cutoff, I mean you should assume ASIP recommendation.

The question is whether the cutoff is 60 or 65%.

whether you have individuals, say, with type 2 and respiratory and CV comorbidities in there. And then I think the other variable we've got is will there be another company there? We compete against that other company right now in meningitis B. High respect for them, but we get 77% of that market share. So I think we're ready for a dynamic contest. And if there is two companies in there, I think the market will expand faster.

Great. Thanks, Luke. Ian, anything else to add on to a specific question on 23?

No, I was given great advice by a colleague at HSBC many years ago to never try to out-analyse an analyst, so I'm not even going to try care. I think, suffice to say, the momentum we're taking out of the first half, the second half performance is very much influenced by the comps from the third and fourth quarter of last year, where we obviously had a pretty strong performance from Shindrix in the third quarter. of last year being a key influence on that. But suffice to say, we've got a visibility to revenue performance in the second half of the year that we believe keeps us consistent with our longer-term, medium-term outlooks of more than 5% and more than 10% adjusted operating profit through to 2026. Although the second half is absolutely going to be a little bit slower than the first half in terms of growth of top line, we still see attractive growth coming through in the second half with momentum into next year. And when we get to our full year results, we'll be sure to give you a more specific view of what next year looks like, both on top line, adjusted operating profits, and adjusted earnings per share.

Great. Thanks, Ian. Next question, please.

The next question is coming from Joe Walton from Credit Twist. Please go ahead.

Good morning. Sorry, good afternoon. I will respect the one question rule, but ask for a clarification. My question is, please, about the general medicines business. It's about one third of your business at the sales level, and it's expected to decline. I wonder if you could tell us if there's any change in your appetite to potentially slimming that down, whether there is the opportunity to sell some of those assets and redeploy the cash in other areas. And my clarification, I apologize, it might just have been Credit Suisse telephony, but the line went very crackly when Luke was talking about the Shingrix stocking. So I wonder if you could reiterate how much of the 2Q performance was effectively brought forward from the second half. Many thanks.

Great. Thanks, Jo. And I'll come to Luke to comment on both of your clarification and your question. But just to say big picture, You know, we've actually done an enormous amount of work over the last five years, as you know, on the portfolio of GSK in the broadest possible sense, including two weeks ago the successful execution of the demerger, and then within GenMed as well. We always keep that as a watching brief. But I do want to emphasize, I think actually last year we said sort of flat to slight decline on GenMed over the five-year horizon. That is a combination of the growth of some assets and some geographies. And then, of course, as Luke referred to, the digestion of some genericizations of parts of the portfolio. But this is a nicely profitable business. And we've got parts of it, like Trilogy, that are growing extremely well. We will always keep a watching brief on that and continue to look from a capital allocation point of view at an overall level, as Ian reiterates, where we want to do BD, and we'll continue to, I think, do more of that with a newly flexible balance sheet, but no major initiatives. But Luke, do you want to do the clarification and add on gen meds?

Sure, Jo. I mean, I think just on gen meds, I mean, we see opportunities to grow elements of that portfolio. I mean, you see a surge in demand from augmentation as things normalise. We have done divestments like CAFs in the past, but I mean, if you take out pressure on products like Ceratide and Advair, this is an outstanding portfolio. And we see opportunities using sort of non-manpower ways to grow growth. In terms of your question around the inventory, just indulge me a little bit. I'll just expand on the broader answer. I mean, I think in half one, we saw very good demand in the US and Europe. Visually, the comparator, if you look at Q1, Q2, 21, it was very low. So percentage-wise, it was a relatively generous comparator. That will not be the case in the second half of the year. We've also got the new launches we talked about. Emma made the point earlier around us trying to expand vaccination outside of the flu season, and we're doing that to normalize, but also obviously with one eye on RSE in our portfolio. And then the other Q1 trends were very much the same into Q2 around HCP willingness and pharmacists willing to rank. Actually, these improved. So the volumes, the wholesalers in the US, I think, have very good forecasts. They've got a good sense of demand. But what we saw through Q1 was that it was within range. We talk about a 1.1 as a normal range. It sort of went up to 1.3. in Q1, and then it started to slide back down as we went into Q2, so 1.2, 1.1, and sat there for a while. But in the back half of Q2, we started to see it climb. So it softened, and then it went from 1.6, 1.8, 1.9, so we finished at 1.9. So if normal's 1.1, 1.9 seems to be pulled forward on the part of wholesalers, and that's certainly the feedback that they're giving us.

Thanks, Luke. Next question, please.

The next question is coming from Seamus Fernandez from Guggenheim. Please, go ahead.

Oh, great. Thanks for the question. So, you know, we saw a good performance of CABINUVA in the quarter and the overall HIV portfolio. Just hoping to get a little bit more color on the treatment versus PrEP utilization, and then just conviction in that this trend is actually accelerating at this point. It does look like strong results, but just wondering if there was anything in the quarter that we should be aware of from a stocking perspective or pull forward. Thanks.

Thanks, Seamus. Well, we have a lot of conviction in this portfolio, but I'll let Deborah explain.

Great. Thank you. So in terms of the balance between treatment and PrEP, I mean, as you probably know, the PrEP market is much smaller than the treatment market. Treatment is currently... round about $23 billion, $23.5 billion with $2.5 billion for the PrEP market. So treatment versus PrEP, significantly different in size. The uptake of Apertude is limited as we've said it would be all along because we need to go through that process of securing access and also setting up the processes, building the market basically for an injectable in the PrEP space. But the feedback that we're getting from physicians and particularly patients about the impact that this medicine will have is phenomenally positive. But I think you'll see that translating to significant revenue next year. In terms of Cabinuva, I mean, another strong quarter where we saw sales doubling. We've simplified the process by which physicians can acquire and administer this medicine. And again, all of the ATU work, so the tracking of the opinion of physicians around Cabinuva continues to strengthen. Confidence is high, and we absolutely see ourselves as being on track to deliver between Apertude and Cabinuva that £2 billion worth of revenue that we talked about in the Business Investor Update last June and reiterated in the the investor session that we did in November, which was solely focused on HIV. So let's just talk a little bit about the growth in the first half of the year. So the first half year is 10% growth. A vast majority of that is driven through volume uptake of our innovation medicines. So we're really seeing strong underlying demand for Devato, both in the US and in Europe. And again, very strong underlying demand for Cavitegravir in the US. So that is the vast majority of why we are delivering that 10% growth. There's a little bit of net price mix in there as we move from the older products, which have higher discount, to the new innovation products, which do not through the mandated channels or to a lesser extent. So this is an incredibly positive story and one that is a story of volume and performance and market share. Thanks, Emma. Next question, please.

The next question is coming from Andrew Baum from Citi. Please go ahead.

Thank you. A couple of questions, please. First one to Hal, given it's my last opportunity on a GSK call. You highlighted the CCL17 monoclonal. Do you feel you have a sub-Q dose that is ready to take directly into phase three? And do you think there's any role for this molecule to addressing the cognitive components of long COVID, just given some of the recent preprints? And then second for Deborah, our recent survey highlighted a shortage of nursing staff as a potential cap as the Cabinuva franchises expands. Are you seeing this as potentially problematic in terms of administering Cabinuva to a broader patient population? Many thanks.

Thanks, Andrew. You just cut out in your question as you were bridging to the long COVID piece. Would you mind just repeating that?

Sure, I was saying...

Hello?

Right, I suggest we get Deborah's answer.

Yeah, I think what Andrew was asking, if I called it correctly, was sub-Q. I think it was one.

Okay, all right, fine. Sub-Q for long COVID and CCL17?

Yeah, sub-Q for CCL17 and then long COVID, I think is what I heard. I think you said optimal dose, but anyway.

Okay. Thank you, Andrew, if you can hear us. So yeah, we're very pleased by the CCL17 MAB data in osteoarthritis for reduction of pain. As you know, that was based on a pretty compelling preclinical hypothesis that CCL17 may be involved in inflammatory pain, maybe neuropathic pain, lots of different preclinical models that have given us some confidence in that. And of course, that was what was, to some extent, behind... the interest in anti-GM-CSF because GM-CSF is the proteins, when you expose a PBMC to GM-CSF, CCL17 is the most overexpressed protein. Of course, a MAB to CCL17 is going to be a much more effective way of reducing CCL17 levels, so we were pleased to see that in the randomized Phase 1b, which is a pretty unusual design, but we decided, given that it's pain and all the challenges with assessing the benefits of a drug on pain, that we would do a small but randomized phase 1B study. Now, that data, as I said, was positive. That is going to enable us to initiate a phase 2 study. We're certainly not ready to move to phase 3 with that. So if there was any confusion, I think you asked, are we ready for phase 3? No, we're going to be needing to do more dose ranging, more durability ranging. So this was an eight-week study. Of course, we'll need longer. And maybe potential to see if there's biomarkers and subsets of patients, whether it be OA or other patient populations of patients with refractory pain that might benefit the most from that. So, yeah, we're very excited based on the biology and the clinical data, but we'll need phase two data to optimize the program. In terms of long COVID, at this point, we have not thought about CCL17 as an approach to long COVID. I think the definition, the epidemiology, the biology behind long COVID is really being challenging to understand and to elucidate the mechanism behind it. But as you point out, it does appear to be inflammatory. But at this point, we're focusing all our energy on developing CCL17 antibody for pain, given the enormous unmet medical need that exists for patients with pain, particularly those who are needing narcotics and all the obvious problems with the opioid issues. So we're really excited about the role that could play in pain and Maybe someday we look to see if it has roles outside of pain.

Great. Thanks, Al. Are there any quick comments on the nursing staff shortage?

Yeah, sure. So we do a huge amount of research like you do, Andrew. Basically, we're building a market, and there are a number of things which, in building that market, can act as a barrier. So nursing staff is one. People within clinics that can actually manage the reimbursement process would be another. And we're supporting clinics to work their way through all of that. So that is about helping with workflows within the physician's offices themselves, but also we're doing a huge amount of work to expand our alternative sites of care. So actually if physicians are struggling with nursing staff or they've got such a volume of Cavanuba patients now that they don't want to handle it all themselves, they can now move their patients into alternative sites of care. And also we're doing a lot of work via a study called Glacier and working with the community to move the injection of Cabiniva and actually Apertude eventually, we hope, into pharmacies. So that kind of starts to unlock that bottleneck. What I am struck by in all the physician visits I do, and I was in Los Angeles the other week, spoke to 10 of the biggest prescribers of HIV medicine and PrEP is just the demand for this product. Both Aptitude and Cabinoo, they have got people waiting on lists to get this medicine. And the unlocker is the process within the physician's office and the ability to refer people into alternative sites of care. And eventually, we hope to do the same in pharmacies. So it's incredibly motivating to see the demand for these incredible medicines that will really revolutionise the lives of those who are living with HIV or who would benefit from PrEP.

That's great. And the other only thing to add in terms of any suppressions, we're still sat on, I think, a switch block because it's down 30%, isn't it, pre-COVID?

Yes, yes, exactly. So when the market continues to come back, then we'll continue to benefit from that.

And then in our more out-of-stage pipeline, but an important one for later in the decade, of course, as well as longer-acting, longer-acting, we're exploring self-admin too, which helps solve some of that challenge.

Next question, please.

Next, we have a question from Simon Mather from BNP Paribas Exane. Please go ahead.

No, thanks. Afternoon all. Thanks for taking my question. I'm just wondering, could you provide any comments on the ongoing Danzac litigation and potential liabilities? I mean, just generally your stance on the topic and whether or not you could quantify what portion of any liabilities, if any, have been transferred to Halion as part of this bin. So just any information you can give us would be greatly received. Thank you.

Thanks, Simon. In the spirit of a short answer to the question, I'm afraid I'm not going to comment, as we never do, on any legal matters like this.

The latest is in the earnings release, Simon, and any more detail beyond the earnings release was per the annual report and accounts published a couple of months ago. So the latest is in the earnings release.

Thanks. Next question, please.

Next, we have a question from James Whitley from Morgan Stanley. Please go ahead.

Hello, thank you for taking my question. I've got one on, a clinical one on Otilimab. So looking at clinicaltrials.gov, Contrast 3 has completed, Contrast 2 will finish in October, and Contrast 1 is expected to finish in September. So should we anticipate that the data will be ready to present at ACR in November? And then ACR 20 is the primary endpoint, which is sort of seen as a reasonably low bar or more of a sort of regulatory endpoint. So What would you say is the key endpoints that physicians are looking at? And what would be the bar for success across those endpoints? And also in the last call, you mentioned that the phase two study failed, or failed to meet the primary endpoint, which was DAS28 remission. So where would you say physician sentiment, knowledge, and excitement is around the program in the context of the phase two data and the upcoming phase three data? Thank you.

Great, thanks. So a variety of sub-questions, Hal, around the Otilamab program.

Yeah, thanks, James. So the way I would think about the Otilamab program is to include in the program the CCL17 because, so think of them as two molecules as part of a hypothesis that CCL17 may be driving the pain associated with, in the contrast studies, rheumatoid arthritis-induced joint pain. The basis for us moving forward, despite, as you point out, a negative phase two study, was that there was this, as I mentioned earlier with Andrew's questions, a reasonably compelling preclinical models that suggested CCL17 was one of the most important proteins in creating this sort of inflammatory neuropathy, if you will. And We did observe that anti-GM-CSF reduced CCL17, but to a smaller extent than, of course, would be seen with a MAP. That then gave us more confidence than one would have had in a negative Phase II study because we did see trends in improvements in symptoms. So the design of the Phase III, as you point out, was to have ACR20 as the approvable endpoint. And given some of the safety concerns seen with some of the other rheumatoid arthritis drugs, We think that's a reasonable endpoint. Of course, if the medicine was to be both successful at ACR20 and reduce pain, that that would be a very differentiated molecule, very high bar. And as I point out, one that you should be thinking of as being part of the CCL17 anti-GM-CSF program. So by the end of the year, I think we'll have a much better sense of how to put both of those molecules into context and to think about how we will advance each

Thanks, Hal. Next question, please.

The next question is coming from Graham Perry from BFA. Please go ahead.

Great. Thanks for taking my questions. So, Hal, a question on the RSC vaccine. And I guess it's always good to go out on a high. And you've mentioned many times now this is exceptional data. I think you've previously used similar language to describe potential vaccine efficacy of over 80% on your primary endpoint. So can we interpret the exceptional comments as referring to primary endpoint or to a more severe disease or secondary endpoint. And given Pfizer is shifting to a more severe disease endpoint, does that match more closely your definition of the infection? So the three symptom definition, your description in clinical trials is perhaps a little looser than that. So will we be able to compare their headline data or their primary efficacy data with yours? And then secondly, on momelotinib, are you expecting a priority review? And how much physician education do you think would be needed at launch on this, given there were two failed studies versus roxelotinib? And you're going into the more advanced setting, or is there just an addressable pool of patients just waiting for therapy here? Thank you.

Thanks very much. Hal, if you could do RSV and initial comments on momelotinib, and then Luke, I'll come to you and see if you have anything to add.

Okay, thanks, Graham. Lots of really good questions embedded in there. Let me clarify two things, because they were done very intentionally. It wasn't exceptional. We said outstanding was more than 75, and I specifically put in the quote exceptional, so they're different. Now, you'll have to see why we use different words. But the exceptional data was referring both to the primary endpoint as well as the key secondaries. And remember, we have an antigen of RCA, and we were from the Phase II data that the treatment effect would be preserved in both A and B, but we didn't have the Phase III data. Now we do, and it is, we're very confident that the treatment effect is preserved in both RSV-A and RSV-B. The most important component of this is the treatment effect, and as I said, we're not going to give the point estimate, but the data is exceptional. The other really important point, just to highlight again, is that we believe that the adjuvant that normalizes the T cell response seen in the elderly compared to that which is seen in the young is really important in terms of engendering a treatment effect in the over 70 where much of the morbidity exists. So that's an incredibly important secondary endpoint for any program. And as we said, the treatment effect in the under 70 and over 70 is very consistent. So that's what is the package that's exceptional. We'll be doing additional analyses on duration and durability, et cetera, as well as some other subgroups. But those patients with comorbidities, as was alluded to earlier, benefit. I'm not going to comment on Pfizer's changing in the primary endpoint other than to say it's unusual that companies do that at the time of unblinding. And, you know, we'll have to look at all of the data very carefully. But the over and under 70 and the durable response are the two key attributes that one are going to need to compare. And that probably won't be something you can do from press release. But you should be seeing the data from our program within the next two or three months. So we're confident a great discussion will ensue. In terms of momilotinib, we don't really comment on regulatory interactions at this point. We're very confident in the data, the unmet need, and the robust nature of the findings. Luke, I don't know if you have anything to add.

Graham, I mean, the deal was constructed on an assumption that we would have that second line block, and so you should assume that at this point. I think at the recent conference where the Phase 3 data was presented, I think people were raving about it. It was very positive. So we remain very excited about the potential, and we've also just filed in the U.S., as you know, and then we'll file the second half of this year in Europe.

Great. Next question, please.

The next question is coming from James Gordon from JP Morgan. Please go ahead.

Hello. Thanks for taking the question. What on HIV? So I think you had said before that Cabinuva plus Aplitude could be more than 2 billion peak. But based on this initial ramp, could maybe Cabinuva be a 2 billion plus product by itself, even ahead of Cab 400 coming along? Or do we need to be a little bit cautious that maybe there's some low-hanging fruits and warehouse patients and things then slow? And also, Aplitude next year, could Cabinuva be a good guide to what the ramp might look like for this product next year? Smaller market, but lots of waitlisted patients, or do we need to be a lot more cautious in terms of taking a few years for the market to really build? And if I could also just squeeze in a clarification, so Blenrep, we heard that gamma secretase combo and a wider dose interval, they're two different ways you could deal with the ocular tox and both look promising. So have you now decided to go down just one of the routes, or are you going to do both? When do you start more trials and when could the sales start accelerating as a result?

All right. Well, now since we seem to have re-baptized questions and clarifications, I'm just going to ask my team to be as brief as possible. Deborah first, then how we can get to as many clarifications left as possible.

Thanks, James. So Cabanova, we're still sticking with the 2 billion in 2026. The competitive landscape, you know, there's a little bit of uncertainty in there at the moment. So how that unfolds could make a difference, but for us, fundamentally, the £2 billion is what we're going to do in 2026, so no change there. Aperture, similar journey to Cabanova. So next year, you will see a ramp-up, which is going to be quite significant on the basis that we'll have solved all of the process and access issues in 2022.

Thanks. I mean, it only says that as well, is that we are very excited about the emerging early stage pipeline of how our longer acting, longer acting is going to be growing through the end of the decade. So I don't see that as a full stop. Hal, anything to add on BCMA?

Yeah, just really clearly, your point's excellent. The GSI combination is a straight, clear synergy, and it is completely independent from the opportunity to improve the benefit-risk profile from a Q4, 6, or even 8-week regimen. So yes, The answer is both of those will be advanced forward as we move to earlier lines. We also, of course, have two other levers. That is the holding for grade two ocular tox as well as the synergy we're observing with pomalidomide and other standard care agents. So all of those will enable us to have a much more robust profile and to enter into earlier lines. I think you said what's the data coming out. We're going to have DREAM-3 soon and DREAM-7. Both of those are in earlier lines, third line and second line respectively. and compared her arm with PFS as primary endpoints. So we're going to be able to see how potentially effective these agents are compared to, you know, Velcade and other standard of care agents like Darzalex as well as in the third line. So very excited about the molecule.

Next question, please. Next we have a question from Simon Baker from Redburn. Please go ahead.

Thanks for taking the question. A big picture question on R&D for you, Hal. You talked about cultural changes that you've implemented during your time. I wonder if you could discuss what the most important cultural changes have been in the R&D organization. And on the basis that the job is never truly finished, what are the key items remaining in Tony's inbox when he takes over? Thanks so much.

Well, I'll let Tony speak for his priorities. He's literally starting next week and you're all going to have a great chance to meet him in coming months and certainly he'll be presenting next quarter. But Hal, I don't know if there's anything briefly that you want to say in terms of the biggest dynamics within the culture change you've been driving. And as Hal concluded, there is always more to do and we remain very focused on that.

Yeah. As I said in the beginning, the cultural change is incredibly important and one that actually will probably take longer than even revitalizing the portfolio. So I think that there's a lot more work to do. The things I'm most proud about the culture is we really did try to drive a culture where there was a limited, if no fear of failing, taking smart risks is the way we called it, which is sort of knowing that in this business, it's very risky. 90% of drugs that enter the clinic will fail. And if one is to trying to avoid selling and never have innovation. So we've, I think, gone a long way there. The second thing, and I won't go through the rest, was that we really tried to be very obsessive with something called single accountable decision-making models, where we identify individuals who are accountable for decisions and not relying on consensus, which I think can kill innovation. So I'm trying to be very brief, but I think we've made a lot of progress on the cultural change, but certainly much more to come.

So we're running a bit long, but I'm going to take two more questions. That culture question we could take up a whole hour and a half on presentations on, and I do not want to take away from the enormous impact and momentum that's already been driven there. So next question, please, and then we'll have one more after that.

The next question is coming from Peter Welford from Jefferies. Please go ahead.

Hi, thanks for taking my question. Just really one thing for Luke, just on our Shingrix. If we go back to what we've seen with the doses, thanks for the detail there, but I wonder if you can just talk a little bit about who it is you're seeing now actually doing the administration. I think we talked about a shift previously from retailers more into the doctors. Has that shift moved back again? and are you still detailing actively to the doctors i guess utilizing i think you said the trilogy salesforce and you talk a little bit about how you're seeing that dynamic potentially evolving now in the second half of the year i guess is covid truly unwinds with the vaccine thank you sure peter so it's stabilized 55 retail 45 non-retail about 60 of the non-retailers is doctors

who, as I mentioned earlier, the trend rate for their willingness to recommend and strongly recommend continue to build. Having Trilogy, and actually we've expanded this to other teams globally, so we have Shingrix in the P2 slot across a whole number of teams, including Nucala teams globally, and it's working very well.

Great, thanks. And final question, please.

And final question is coming from Emily Filch from Barclays.

Please go ahead. Hi, thank you for fitting me in. Clarification is exceptional better than outstanding. And then question, just on the guidance, decision to maintain the year-over-year growth rate for specialty, given that the HIV guidance was nudged up a little bit. Is there a deterioration in any other elements of the business there, or just perhaps a broader air of conservatism? And then also, just what drove the slight moderation in influenza guidance for the year? Was that share or anticipated market sizing? Thank you.

All right. Well, Ian, perhaps you can comment on guidance, and then we'll come to Hal. for the specificity of the distinctions in his vocabulary, and then I'll close up.

Yeah, no, it's a very good question. It's basically around proportionality. So the comments that Debra made earlier around the performance of HIV are material in the HIV context. When you put it in the context of the specialty medicines portfolio overall, it's not sufficiently material to kind of lift up the guidance for specialty medicines overall. So it's not as if it's offsetting something else within specialty, it's just in terms of proportionality, it doesn't move the needle for specialty overall.

Well, let me just say as my last comment on my last call, that it's a real honor to say that the question as to whether outstanding or exceptional is how you would define the phase three results for one of the most important trials done in the last 60 years for RSV is incredibly inspiring. And you can decide when you see the data.

Perfect. So, right. Well, thank you, everybody. We are delivering. And I'm absolutely delighted that we've been able to upgrade our guidance this year and demonstrate pipeline progress, included with Hal's concluding comment, as well as tremendous commercial momentum. We have delivered a successful separation and the biggest change for GSK in two decades and created the capacity to continue to invest in future innovation and growth. I do want to conclude with my own very sincere thank you to Hal for the enormous impact he's had on the momentum of GSK. We're really looking forward to his graduation, to being a member of the science committee and the non-exec director of the board. I know he'll continue to contribute wonderfully, and I know how much Tony is looking forward to spending time with you all in the coming weeks and months, and we'll look forward to seeing you in the days ahead. Thank you very much. See you soon.