GSK - Q2 2023

Transcript

Operator (participant)

Hello, everyone. Welcome to our half year in Q2 2023 conference call and webcast for investors and analysts. The presentation was sent to our distribution list by email, and you can also find this on gsk.com. Please turn to Slide 2. This is the usual safe harbor statement. We'll comment on our performance using constant exchange rates or CER, unless stated otherwise. As a reminder, following the consumer healthcare demerger in 2022 to Haleon, we're presenting performance and growth from the continuing operations for GSK. Please turn to Slide 3. Today's call will last approximately one hour, and the management presentation will take between 30-35 minutes, with the remaining time for your questions. For those who wish to ask a question, please join the queue by raising your hand.

Press star nine to raise and lower your hand if you're on the phone, and we request that you ask one question so that everyone has a chance to participate. Our speakers today are Emma Walmsley, Tony Wood, Luke Miels, Deborah Waterhouse, and Julie Brown, with David Redfern then joining the rest of the team for the Q&A portion of the call. Turning to Slide 4, I will now hand the call over to Emma.

Emma Walmsley (CEO)

Thanks, Nick, a very warm welcome to everyone joining us today. I'm delighted to be presenting to you all another set of excellent results for GSK. Please turn to the next slide. Sales and profits grew at double-digit levels for the quarter, our sixth consecutive quarter of strong growth. Sales were GBP 7.2 billion, up 11%, excluding pandemic solutions. Adjusted operating profit was up 12% to GBP 2.2 billion, and adjusted EPS were up 17% to GBP 0.388. This is further evidence of a sustained step change in GSK's performance, and this momentum supports our decision to upgrade our guidance for the year. Our performance also demonstrated delivery of the strategic choices we've made to develop the portfolio and the R&D pipeline.

New products, notably in vaccines and HIV, all made healthy contributions to growth and reflect the investments we've made to prioritize these parts of our business. 62% of sales are now coming from vaccines and specialty medicines, which we expect to provide durable and profitable growth through the decade. New products launched since 2017 have contributed sales of GBP 4.6 billion so far this year, adding nearly GBP 1 billion of additional turnover compared to 2022. Our general meds business continues to perform alongside the other parts of our portfolio. Next slide, please. We are deploying capital in a financially disciplined way to invest in growth and deliver stronger returns to shareholders. We are delivering on our commitments, and as you can see from the slide, we are on track to hit all the targets we set out in 2021.

As you all know, our very first priority for capital remains to invest in continued pipeline progress, and we know this is the key question for shareholders. At the core of our work is an aggressive pursuit of organic pipeline delivery and targeted business development. We're making good progress on both, and there is more to come. The approval of Arexvy this quarter is, we believe, transformational and set to bring enormous benefit to people aged over 60, who are at annual exposure of RSV. Arexvy is spearheading the next wave of vaccine innovation at GSK. This quarter, we presented positive clinical data for our pentavalent meningitis vaccine, secured regulatory approval for Shingrix in Japan in at-risk populations, and achieved U.S. FDA Fast Track designation for our candidate vaccine to prevent gonorrhea, a bacterium that is considered a high-priority pathogen by the WHO.

As you'll have seen at our recent Meet the Management event, we have substantial innovation to come with potential new vaccines to prevent influenza, pneumococcal disease, and herpes simplex virus. This all sits alongside other innovation in infectious diseases like bepirovirsen for hepatitis B, and a new portfolio of much-needed anti-infectives. We're also very pleased with the progress we're making in our HIV portfolio. A key aspect here is, of course, to develop the portfolio to replace the loss of exclusivity for dolutegravir, which, as a reminder, is not expected to start until 2028 in the U.S. and 2029 in Europe. We are well on track to do this. We expect sales from our new long-acting regimens of around GBP 2 billion by 2026.

To add to this, clinical development plans are advancing very well to support new ultra-long-acting options launching from 2026. With these innovations, we aim to replace the majority of revenues from dolutegravir and support profitable growth for GSK well into the next decade. We're looking forward to talking to you more about all this at our HIV Meet the Management event in late September. Equally, we continue to make good progress in our business development. Here, we're targeting acquisitions and partnerships to strengthen and complement our core therapy areas to help deliver above and beyond our current long-term outlooks. You should expect to see us keep up broadly the same levels and pace of BD as we have in the last 18 months.

This quarter, we completed the acquisition of BELLUS Health, building upon our respiratory expertise with the addition of Camlipixant, a phase III potential best-in-class treatment for refractory chronic cough. Our pipeline in broader respiratory is developing well, too, across all three product areas. We're increasingly confident it will be a major source of new long-term growth. Next slide, please. Our focus is to deliver competitive performance and improve shareholder value in the short, medium, and long term. With our current momentum and further successful execution of our priorities, we are very confident in our ability to deliver profitable sales growth in all three of these time frames. For 2023, we now expect to deliver sales growth of 8%-10% and adjusted operating profit growth of 11%-13%.

For 2026, we expect to deliver sales of more than 5% and adjusted operating profit of more than 10% on a CAGR basis. By 2031, we're confident we will have effectively absorbed any impact from the loss of exclusivity across the portfolio to deliver our stated ambition of more than GBP 33 billion in sales. We know this ambition is significantly higher than current market expectations, and over the next year, we'll continue to bring you more clarity and specificity on our building blocks that deliver profitable results through a series of media management events, data readouts, and a more comprehensive update against our 2021 long-term plan. Let me now hand over to Tony, who will talk you through his latest thoughts on R&D priorities and performance.

Tony Wood (hief Scientific Officer, and President of Research and Development)

Thank you, Emma. Hello, everyone. It's great to be with you today. Please turn to Slide 9. I'm pleased to report that we're making good progress in strengthening the pipeline. I know there's more to come. Our absolute focus is to deliver a pipeline that can drive sustainable, profitable growth. I think being achieved through a combination of organic delivery and disciplined business development, overlaid with continuous improvement in R&D productivity. This is reflected in my three priorities for R&D, shown on this slide. In the delivery of our strategy, which is focused across four therapeutic areas, enabled to leverage our deep understanding of the immune system and use of advanced technologies. Next slide, please. It's important that we allocate our capital and resources effectively. I think about this from two perspectives.

First, from a therapeutic area standpoint, our priority is to build on our strengths and leadership in infectious diseases, HIV, respiratory immunology, and our emerging capabilities in oncology. This is by investing in both organic and targeted business development to deliver first or best-in-class innovation, balancing probabilities of success and sales potential. We apply the same discipline and returns criteria for both approaches. In addition, we also see platform and data technology-enabled opportunities. Second, from a time perspective, I want to develop, partner, or acquire vaccines, specialty medicines, and technologies with significant commercial potential that can meaningfully contribute to sales and profit growth in the latter part of this decade and beyond. Ultimately, I want a portfolio of R&D options that offers a good balance of risk and return, and which can drive growth to GSK above and beyond the ambition, sorry, I just talked about.

Slide 11, please. Our pipeline to date comprises 68 assets in clinical development. Two-thirds of the assets within our development portfolio are focused on infectious diseases and HIV. In infectious diseases, we're focused on seasonal respiratory viruses, bacterial, fungal, and chronic viral infections. Vaccines are front and center of this effort. Emma has already mentioned Arexvy and some of the innovation that is coming behind it. Our pentavalent meningococcal vaccine candidate recently met all primary endpoints in the phase III trial and demonstrated immunological effectiveness against 110 diverse Meningococcal B strains. These account for 95% of circulating strains in the U.S. Five serogroups are responsible for most meningococcal infections, no single approved vaccine can yet protect against all five. If approved, MenABCWY would do so, offering a simplified immunization schedule and supporting increased vaccine uptake.

This is important when you consider that only 30% of adults currently receive full protection from all five meningococcal serogroups. We're on track to submit the vaccine to regulators in 2024. Our novel 24-valent pneumococcal vaccine candidate, acquired through the Affinivax transaction, has also shown very positive immune response across serotypes. We continue to examine potential acceleration options for the 24-valent and 30-valent programs in infants and adults. With CureVac, we're looking to disrupt the influenza market and deliver new multivalent combination vaccines using next-generation mRNA technology. Multivalent phase I and II flu and COVID trials are underway. We'll expect data from these towards the end of this year and the start of 2024. In chronic viral infections, in addition to geographic expansion, we're looking at new growth opportunities for Shingrix.

These include extending the population who might benefit from protection to a younger cohort, such as the recent Japanese approval to include adults aged 18-49. We continue to review the potential need for a booster. Additionally, a growing body of evidence suggests that shingles vaccination may reduce the risk of dementia, and we're leveraging our expertise in varicella zoster virus to develop a promising injectable treatment for the control of herpes simplex virus reactivation. Our plan is to initiate proof of concept studies later this year. In anti-infectives, we've now assembled a promising portfolio of new medicines. Gepotidacin, which has stopped early for efficacy and is anticipated to launch next year, has the potential to be the first oral antibiotic to treat uncomplicated urinary tract infections in more than 20 years.

Complementing this is tebipenem from Spero Therapeutics, which, if approved, will provide us with access to a late-stage antibiotic with the potential to treat complicated urinary tract infections. Brexafemme, a novel first-in-class to treat fungal infections, acquired through an exclusive license agreement with SCYNEXIS, completes this trio. Here is another potentially transformative treatment which could help patients achieve a functional cure for chronic hepatitis B. We look forward to presenting data from our phase IIb trial B-Together later this year. This trial is designed to answer whether interferons need to improve the durability and functional cure following therapy treatment. In HIV, we're entering an important period in our development plans for potential ultra-long-acting treatments and prevention options. This year has a transition we expect to deliver in HIV portfolio over the next five years.

We'll be setting out more detail in our 3rd quarter investor event. In respiratory and immunology, we're prioritizing late-stage development of our IL-5 antagonist, depemokimab. The addition of Camlipixant, a highly selective P2X3 antagonist, the treatment of refractory chronic cough, also provides us with another asset in phase III development. Luke and I expect to be sharing more with you on our plans and opportunities in respiratory before the year end. In oncology, we're progressing the regulatory submission for momelotinib, following FDA's recently extended review date to September. We're confident this new medicine will help tackle the significant and debilitating medical needs of myelofibrosis patients with anemia. Given the makeup of our current portfolio and capabilities, our approach in oncology is to prioritize the development of novel medicines to treat blood and risk cancers and to explore other potential breakthroughs in immuno-oncology.

Jemperli, our highly effective PD-1 inhibitor, is central to this approach. Exploration as a backbone treatment for use in combination with further proven or promising therapies is in development. Next slide, please. You'll see how many of the elements I've just touched on are expected to play out over the next 12 to 18 months. I believe these, together with targeted business development and a series of important phase II investment decisions, will lead to significant progression of this pipeline in the short term. Slide 13, please. Alongside allocating resources to prioritize and accelerate clinical development, I want us to continue to improve overall R&D productivity. We've made progress. Success rates and cycle times are improving. More needs to be done. For me, this really means 2 things. First, doubling down on leveraging our scientific capabilities with the use of new platform and data technologies.

Second, developing our partnering and external sourcing capabilities. With AI and machine learning applications now rapidly maturing, access to proprietary data to feed models and generate novel insights is a key strategic differentiator. For example, we recently presented data and results for better use from the B-Clear phase IIb trial. This deep multimodal analysis helped us to develop a clear heterogeneity map in chronic hepatitis B, stratifying individuals treated with bepirovirsen in 3 subtypes: a highly enriched response, a mixed response, and a non-response subtype, each defined by distinct clinical, virological, and molecular trajectories, and associated with a number of markers. These predictive models provide greater precision than existing markers and suggest potential enrichment strategies. We're competitively placed in platform technologies and have laid strong foundations in data technologies.

I want us to now vigorously scale and build on these foundations, rapidly test and progress high-quality, first-in-class candidates, all with the aim of accelerating and improving the success rates of our development programs. In summary, let me close by saying I'm pleased with the progress we've made so far this year, that we have clear plans in place to move forward at pace to deliver on our key objectives for R&D and support the overall growth ambitions to GSK. I'll now hand it over to Luke on Slide 14.

Luke Miels (Chief Commercial Officer)

Thanks, Tony. Please turn to the next slide. Pleased to say that quarter two was another quarter of continued strong commercial execution with growth across the business. All three of our products are expanding. Specialty internal medicines were up in the quarter with growing contributions across all three regions. Please turn to Slide 16. In quarter two, we delivered GBP 7.1 billion in sales, up 11% versus last year, excluding Pandemic Solutions. In vaccines, strong growth of 15%, excluding Pandemic Solutions, was supported by Shingrix, which was up 20%, and Bexsero, which was up 18%. Shingrix delivered another record quarter of sales, and it's the sixth quarter of growth. In the U.S., we've now reached the most motivated consumers, with about 32% penetration of eligible people receiving at least one dose.

Moving forward in the U.S., we're resourcing for success by raising awareness about the importance of Shing prevention, especially among consumers who are less motivated to get vaccines. We remain confident in the U.S. opportunity and believe we can reach flu-like penetration of around 60%-65% over time. Ex-U.S. remains an important growth driver for Shingrix and represented 46% of the revenue in the quarter. Shingrix is now available in 33 countries, with most with less than 3% penetration, indicating the potential for further expansion in these populations. We've got unconstrained supply and strong global demand, and we continue to retain high value with U.S.-like pricing as we launch in private pay settings globally. In specialty medicines, including HIV, which Deborah will speak about shortly, we increased sales by 12%, excluding Xevudy, to GBP 2.5 billion.

Our market-leading blockbuster specialty medicines, Benlysta and Nucala, continued to deliver double-digit growth. Benlysta was up 19% in the quarter, with sustained growth across all major markets, with further opportunity to drive increased penetration in both SLE and lupus nephritis, with about 25% buyer penetration in the U.S. and other key markets. We're focused on life cycle management opportunities for Benlysta as we explore further indications, including systemic sclerosis associated with interstitial lung disease, which will be important for patients as well as having a continued halo effect across the entire product. Nucala was up 15% in the quarter and remains the first and only biologic approved in 40 eosinophilic diseases, with new indications driving growth and differentiation. The severe asthma market continues to grow in the U.S., with opportunity for Nucala to drive buyer penetration with our clearly differentiated profile in high EOS patients.

We look forward to having CFP data in 2024. In oncology, sales were down 3% in line with expectations. Jemperli continues to be a growing contributor, and we're excited about the potential for our PD-1 as a development program, investigates the opportunity to help more patients with endometrial ovarian and potentially other indications. Our general medicines portfolio grew 8%, driven primarily by Trelegy, which was up 30% in the quarter. Trelegy continues to have a best-in-class profile across access versus competitors, and there's a leading share of voice with key specialty HCPs like pulmonologists and allergists. Considering this strong Q2 and H1 performance, we now expect specialty medicines to grow high single-digit, and general medicines to grow at low single-digit in the full year. We still expect vaccines to grow in the mid-teens. Please turn to Slide 17.

We're very excited about the outcome of Arexvy. We believe Arexvy's profile and recommendation to support our market leadership and position with multi-billion annual sales potential. Additionally, the CDC has now adopted last month's ACIP recommendation. It is being communicated broadly to healthcare providers, an important step that sets clinical guidance and establishes a trigger for payer coverage, which is now underway as we speak. We have a clear understanding of what is required for successful commercial execution. We're also building on our relationships with retailers, given our expertise with the older adult population through Shingrix. We're playing to our strength using our deep prescriptive equities and our experienced Trelegy primary care sales force.

We've now shipped doses to distribution centers, and we look forward to the impact that this important medicine will have on help prevent the severe consequences of RSV in the U.S. and globally, as we also prepare for launch this season across Europe. With that, now let me hand over to Deborah on Slide 18.

Deborah Waterhouse (President of Global Health)

Thanks, Luke. Our HIV business delivered sales of GBP 1.6 billion in the 2Q 2023, growing 12%. This growth was primarily driven by demand, which contributed 8 percentage points of growth and U.S. pricing favorability, which contributed a further 2 percentage points of growth. Our performance benefited from strong patient demand for our oral two-drug regimens and long-acting injectable medicines, which now constitute more than 50% of our total portfolio. This demand helped grow our global market share by 2 percentage points versus last year. The inventory builds that we saw in the U.S. at the end of last year have now materially burned, and we don't anticipate any further significant burn this year. Dovato delivered GBP 430 million in the quarter.

Market performance reflects HCP belief in Dovato, which is now our number one selling HIV medicine. We were also pleased that dolutegravir received U.S. FDA pediatric exclusivity in the quarter, which extends the dolutegravir loss of exclusivity in the U.S. by a further six months to April 2029. As a reminder, Europe is to April 2028. As a reminder, Europe is 2029. We aim to further consolidate our leadership in pediatric HIV by following a similar approach with our foundational medicine, cabotegravir. Tenofovir sales for the quarter were GBP 176 million, reflecting strong patient demand with high levels of market access and reimbursements across the U.S. and Europe. Growth is being driven by positive sentiment towards the SOLAR data presented at CROI earlier in the year and strong commercial execution.

It is particularly pleasing to see that more than 70% of Cabenuva sales are originating from competitor regimens. Moving on to prevention. Sales of Apretude, the world's first long-acting injectable for the prevention of HIV, delivered GBP 36 million in the quarter, and we're pleased by the growing momentum across the U.S. We were delighted that earlier this week, the European Medicines Agency granted positive opinion for this medicine. With more than 100,000 new infections every year across the continent, we very much look forward to the approval of Apretude, which has the potential to significantly reduce the transition of HIV in Europe. We're encouraged by the progress of our pipeline, which is focused on innovative long-acting regimens.

We have 3 clear target medicine profiles: the world's first self-administered, long-acting regimen for treatment, and to provide oral long-acting regimens for treatment and prevention, with dosing intervals of 3 months or longer. I'm pleased to confirm that next month we shall begin our phase IIb study of cabotegravir in combination with our broadly neutralizing antibody VRC07-523LS, which offers the potential for ultra-long-acting dosing. We are very excited about the potential of these medicine profiles and will be ready to progress with X in 2024. We remain very confident in our ambition to achieve a 5-year mid-single digit % sales target to 2026, and our strong Q2 performance means we are in a position to raise our outlook for 2023 from mid-single digit % to a high single digit % growth rate. With that, I will hand to Julie on Slide 19.

Julie Brown (CFO and Executive Director)

Good afternoon, everyone. I am delighted to be here at my first set of results as the CFO of GSK. The biopharma industry is incredibly special to me. It's where I've spent most of my career, it is a sector that can create enormous value for patients and shareholders. GSK is a company that I've long admired, it has a clear purpose to positively impact the health of billions over the next decade. I'm really pleased to be part of the team that is going to deliver this. As this is the first time speaking to you, and before we cover the financials, I wanted to take the opportunity to highlight three areas of focus that are going to be important to me as CFO. First, disciplined capital allocation, with two clear priorities: To invest for growth and to deliver improved returns to shareholders.

Partnering with Tony Wood to enhance returns on investment and improve R&D productivity, with a strong focus on resource optimization and efficient funding. Identifying sources of business efficiency to fund investments and deliver a competitive P&L. First, turning to the next slide in capital allocation. Our first priority is investment in the business, driven towards development of the pipeline through both organic and targeted business development. We will also invest to support new product launches. My intention here is to be laser-focused on prioritizing and accelerating investment in those assets and technologies which will help us to deliver growth. I intend to achieve this through an increased focus on ROI for organic and BD-related investments, and this will include an assessment of the market opportunity, first-in-class potential and best-in-class potential, peak year sales, probability of success, and expected financial returns.

For returns to shareholders, our primary mechanism for cash distributions will remain through the delivery of a progressive dividend. Last year, the payout ratio of 40%-60% over the cycle was established, and we expect to maintain dividends within this range as earnings increase over time. For completeness, in the event of a surplus, excess cash would be returned to shareholders using the most efficient mechanism available. However, we do not expect excess cash in the medium term, given our priority is to invest in growth. Finally, and very importantly, we remain committed to maintaining a balance sheet with a strong investment-grade credit rating. Taken together, I believe this represents a sensible capital allocation framework for GSK, consistent with our strategic priorities and supportive of our commitments to deliver profitable growth through this decade. Turning now to the quarter.

I cover the financials, references to growth are at constant exchange rates, unless otherwise stated, and I will focus my comments on adjusted results. Starting with the income statement. Sales increased 11%, excluding pandemic solutions, and were up 4% overall, reflecting the strong delivery that Luke and Deborah have covered. Operating leverage, primarily in COGS, drove adjusted operating profit growth of 11%, with the margin increasing to 30.2%. Excluding pandemic solutions, adjusted operating profit grew 12%. Turning to the reported results, the growth in total profit was driven by a strong operating performance and favorable contingent consideration liability remeasurements. Please turn to Slide 22. Turning to margin dynamics. As mentioned, the adjusted operating margin was 30.2%, a 200 basis point increase versus the prior year at constant rates.

Excluding the impact of pandemic solutions, the margin increased 20 basis points. Cost of goods sold decreased, primarily reflecting reduced sales of low margins of Xevudy Q2, which resulted in a gross profit increase of 11%. Excluding pandemic solutions, COGS increased in line with sales with a neutral gross margin impact, with favorable mix and efficiencies offset by higher freight and energy costs. SG&A reflects investment behind product launches such as Shingrix, geographic expansion, HIV, and preparations for Arexvy's imminent launch. We expect the SG&A growth to reduce in the fourth quarter as investment levels stabilize and to be broadly in line with sales growth for the full year. In R&D, there was increased investment across a range of early and late-stage programs, including a number that Deborah and Tony discussed earlier.

Royalties benefited from Gardasil, Biktarvy, and Kesimpta, and there was a 70 basis point adverse move from foreign exchange. Next slide, please. Earnings per share benefited from lower net finance expense and non-controlling interests. Now turning to the adjusted compared with our total results. Next slide, please. Overall, total unadjusted operating profits were similar in the second quarter at GBP 2.1 billion and GBP 2.2 billion, respectively. In addition to CCL remeasurements, the main other adjusting items of note were within divestments, significant legal, and other, and this reflected dividend and distribution income received, including Haleon dividends and the fair value movements of Haleon shares, which was partly offset by significant legal charges. Legal fees primarily reflected increased charges to Zantac, of which the vast majority relate to prospective legal costs for the defense. Next slide, please.

Cash generated from operations was GBP 1.9 billion in the first half, GBP 2 billion lower than the prior year. The key drivers are similar to those covered at Q1, and relate to the Gilead settlement and timing of the ViiV collections received last year, together with pension payments and increased working capital this year. There was no change to our expectation that 2023 cash generated from operations will be slightly lower than 2022, and we remain committed to our 2026 projection of more than GBP 10 billion. Net debt increased to GBP 18.2 billion, reflecting the free cash outflow and net acquisition cost of BELLUS Health, partly offset by disposal of investments, including the monetization of part of our equity holding in Haleon. Turning now to guidance on Slide 26.

We have delivered a very strong first half, and as Emma mentioned, we are upgrading our guidance for the year. As a reminder, all of this guidance excludes the impact of COVID-19 solutions. We now expect sales to increase between 8% and 10%, up 2 percentage points. We expect adjusted operating profit to increase between 11% and 13%, and adjusted earnings per share to increase between 14% and 17%. Within sales, we are maintaining our full year vaccines expectation of a mid-teens percentage growth, and are upgrading our expectations for Specialty and General Medicines. We now anticipate Specialty Medicines and HIV within it to grow a high single digit percent and for General Medicines to grow a low single digit percent. Turning to phasing, and firstly on sales, we expect that the second half growth will be below the first half, informed by the comparatives.

We would also expect sales growth to be slightly higher in Q3 relative to Q4. Secondly, on operating profit, we expect that the second half growth will be stronger than the first, with a broadly similar growth rate in each quarter, primarily reflecting SG&A growth expectations, as mentioned earlier. Next slide, please. In summary, our business is performing well and with strong momentum. I look forward to connecting with you and updating you on our progress and continued delivery towards our 26 and 31 goals in the quarter. With that in mind, slide 27 shares how we plan to keep you informed in four key areas: execution, portfolio, capital allocation, and investor events. Execution shares our major earnings and reviews. The portfolio component builds on the R&D catalyst shared in Tony's presentation.

Capital allocation has been clarified further today, the investor relations program shares how we plan to provide you with the building blocks underpinning our pipeline and the opportunity to meet the management at 2 more events this year. The first will focus on HIV in September, followed by respiratory and immunology in the fourth quarter. We will also continue to run a comprehensive program of meetings, participation in investor conferences, and updates from key medical events. Thank you, and with that, I will hand back to Emma.

Emma Walmsley (CEO)

Thanks, Julie. It's great to have you with us. Turning to Slide 29. We continue to build trust by delivering in the six key areas we prioritize for ESG performance. This quarter, we made progress on several fronts, but I want to highlight one in particular. Of the more than two and a half billion people we'll reach this decade, the majority will be through our infectious disease portfolio of vaccines, antibiotics, antivirals, and global health products. We were delighted to see new third-party funding announced to advance M72, a tuberculosis vaccine candidate, discovered and developed by GSK into phase III development. This could potentially become the first new vaccine to help prevent pulmonary TB in more than 100 years.

It is a true testament to GSK's vaccine scientists and our ability to partner with others to develop innovative global health assets in an economically viable and sustainable way. With more than 10 million people falling ill and more than one and a half million people dying from TB every year, and increasing evidence of drug resistance, the successful development of this vaccine could have a profound impact on human health. Final slide, please. In summary, we are seeing strong momentum in our performance with continued delivery of competitive sales and profit growth. We remain very focused on continuing to progress our pipeline through organic development and targeted complementary business development, and our progress is providing us with high confidence to deliver our outlooks and ambitions for shareholders through the decade. With that, let's move to the Q&A with the team.

Operator (participant)

Thanks, Emma. Just as a reminder, for those that wish to ask a question, please join the queue by raising your hands. If you're on the phone, please press star nine to raise and lower your hands. Again, just request that you ask 1 question in the first instance, and then we can always come back for a second round. Let's take our first question from James Gordon at JPMorgan. James, you're able to speak, so over to you, please.

James Gordon (Managing Director, and Senior Analyst, European Pharmaceuticals)

Hello, James Gordon, J.P. Morgan. Thanks for taking the question. I'll keep to one. My question's about Shingrix in the U.S. I think sales declined 10% this quarter, or maybe it's sort of flattish when we adjust for stocking, but I saw you've refined the Shingrix global guidance, so it's now high teens this year. I think it was double digit before. And Luke made some comments about having reached the most motivated patients in the U.S. and further penetration increases, but that sounds like maybe that's going to be tougher in the less motivated patients. So the question is: where are we on Shingrix in U.S. growth specifically?

Could we now be running out of road for the U.S. growth, and it's going to be more ex-U.S. growth, but the U.S. is maybe sort of flat this year and then could even decline? Is Q2 a bit of a blip in the stocking and other one-off factors, and there's still plenty of U.S. growth to come?

Emma Walmsley (CEO)

Thanks, James. obviously, we're still very ambitious for, the scale and reach of Shingrix, but Luke, do you want to specifically comment on the dynamics of the U.S.?

Luke Miels (Chief Commercial Officer)

Sure, James. I suspect you're probably not the only person with that question, so I'll take a little bit longer to cover all those points. The short answer is not yet. I mean, we've covered in past calls, there will be a point, which we're entering now, where we'll need to work harder to go up this, what essentially a logarithmic growth curve. Yeah, I'll take a little bit to outline those dynamics because it's very much a non-retail effect right now. As you said, with some stock movements. For retail first, we actually saw an 8% growth, or up 8% versus last year, and that was pretty much driven by 65-year-olds, individuals coming in following the removal of the co-pay linked to the IRA.

It's interesting, in Q4 and Q1, we added about 2% to the total vaccination rate each time. We're now at a penetration of around 32% on the latest data that we have, which is Q1. If you then sort of subtract that's about 80 million more people to go if we were to get to 100%, and we add around 4 million people who turn 50 each year. The other important one on stocking is we actually changed the rules, in terms of how much stock wholesalers could hold. We have 2 categories, category A and category B. Historically, Shingrix has been classified category B, which just gave wholesalers more room and more flexibility in terms of the volumes that they hold.

We've now tightened that up to try and remove some of this volatility. If you remember last year, we had stock movements, which were sort of 1.3, 1.8, and down to 1, to down to 0.9. So far this year, we're pretty tight in the range of 0.6 to 0.7. Expect it will go up a little bit at the end of Q3 in the flu season, but we're trying to keep a tighter collar on that. That has an effect as well. Now, if we go to the non-retail, this is the important component in the U.S., and this is the key share. Historically, non-retail has been around 45%-50% of the business, but in Q1, that went down to 34%, and in Q2, it's around 31%.

It's very specific. We have a very small number of key customers who are now approaching 60% of the target population in their vaccination. Now, we have about 197 other key customers that we can work for. I guess the glass half full look at this is that we can get to the types of penetration that we're targeting in these centers. That's an opportunity with the other ones. You're right, we do need to work harder to get to those less motivated patients, but we've always known that's coming, and we've got plans to do that. If we look outside of the U.S., just to conclude, we sort of try and explain historically that we have these three phases here.

The U.S., which, you know, is sort of done on that curve. We're now starting in Europe, and we have very early days in markets like Canada, China. As you said, we're about 3% penetration if you exclude the U.S. and Germany, which are ahead of the curve with deeper penetration. We're in good shape overall, and I think look forward to updating you on Q3.

Emma Walmsley (CEO)

Thanks, Luke. The other point to emphasize is, as Luke referred to, the cost of rooting deeper in the U.S. obviously goes up, and actually, in the other markets we're in, because you don't have advertising, and because pricing has been successfully globalized, you know, it remains a very appealing business in adult immunization, which of course we're now adding to with RSV and additional pipeline beyond that. Next question, please.

James Gordon (Managing Director, and Senior Analyst, European Pharmaceuticals)

Next question is from Jo Walton at Credit Suisse. Please, Jo.

Emma Walmsley (CEO)

Jo? Hello?

James Gordon (Managing Director, and Senior Analyst, European Pharmaceuticals)

Jo, yeah. Yeah.

Emma Walmsley (CEO)

Hi.

Jo Walton (Research Analyst, and Pharmaceuticals Analyst)

Yep. Thank you. I would like to ask a question about IRA. Two aspects of that. I wonder if you have a view about increased volume in anything other than vaccines, given the change in patient co-pay going down, and also if you could talk about penny pricing and how we should think about that. You have some old products which will have accumulated very large rebates, which in theory, you know, would become a problem next year. We've seen the insulin-

Emma Walmsley (CEO)

Yeah

Jo Walton (Research Analyst, and Pharmaceuticals Analyst)

... companies talk about it. How are you going to handle that in respiratory? Thank you.

Emma Walmsley (CEO)

Thanks, Jo. I'll come to Luke throughout, but you're absolutely right. There are some really good things about the IRA that we're very supportive of. The co-pays in removal in vaccines is important for our portfolio. There are some other things that, alongside others in the sector, we're concerned about in terms of unintended consequences. Two parts of our portfolio, HIV will be more likely in 2025, and then in gen meds from next year, there is some impact, all of which is explicitly absorbed in our guidance and in our outlooks. You'll see some volatility there, but Luke, I don't know whether you'd like to comment more on the specifics in established respiratory.

Luke Miels (Chief Commercial Officer)

Yeah, sure. I mean, Jo, you're bang on in terms of compliance, and then we see patients drop out of products like Trelegy, in terms of that historical coverage gap. That should help with the volume. As Emma said, there's other aspects to the program that we're less than optimal, and we need to see how they affect. In terms of AMCAP, we've got a very clear list of products, exactly as you said, that have had pretty intensive discounting and historical price increases, which have been, you know, ahead of inflation. Those rebates commercial pay will have effect. I mean, the total exposure, this is just total revenue, not impact. I want to really stress this, about $700 million.

That's Flovent HFA, Flovent Diskus, Advair HFA, Advair Diskus, Serevent, and Lamictal. The biggest of those is Lamictal. Now, we've had a lot of warning that this is coming, and we're working. The U.S. has done a great job in terms of developing authorized generics, partnerships. We have options to divest selected products, and where we can't bring an authorized generic, or we are unable to divest, of course, we can always lower the WAC to adjust that. That's a collection of approaches that we're doing to fix the bulk of that business.

Emma Walmsley (CEO)

Thanks. Next question, please.

Operator (participant)

The next question is from James Quigley at Morgan Stanley. James, over to you, please.

James Quigley (Executive Director, European Pharma and Biotech Equity Research)

Great. Thank you very much. Maybe a question for Julie, picking up on one of her comments. You mentioned sort of building a competitive P&L. What is your definition of a competitive P&L, and what sort of focus areas to generate that competitiveness in terms of margin ranges or growth potential? Are there any sort of early areas that could drive efficiencies or levers that you can use to get you into these competitive ranges? Thank you.

Emma Walmsley (CEO)

Thanks, James. I'll straight to you, Julie.

Julie Brown (CFO and Executive Director)

Okay. Thank you very much. Thanks, James. In terms of, I see a competitive P&L as one that's operating to full capacity and making optimal use of the resources in the business and on capital allocation in the business. I think progress has been made in GSK already, following the separation with the Future Ready program. I mean, clearly, at the moment, we're in the launch cycle with a number of important medicines and vaccines being brought to the market, as Luke and Deborah both mentioned. As we move beyond this, of course, we will continue to look for efficiencies. We do anticipate, once we're through the launch cycle, that SG&A will grow at a slower rate than sales, thereby, improving that particular margin.

Working with Tony closely, because obviously, I've been in the pharma industry for a long time. I worked with R&D for a long time. Clearly, investment in productivity and resource allocation in R&D is critical to a pharmaceutical business. As you can imagine, I will spend some time looking for continuous improvement and opportunities to fuel business efficiencies to fuel further growth.

Emma Walmsley (CEO)

Thanks, Julie. Next question, please.

Operator (participant)

The next question comes from Emily Field at Barclays. Over to you, please, Emily. Emily. Okay, can I propose we take the next question from Peter Welford? Peter, over to you please.

Emily Field (Director, Head of European Pharmaceuticals Equity Research)

Oh, no, I'm here. I mean, can you hear me?

Operator (participant)

Uh-

Emily Field (Director, Head of European Pharmaceuticals Equity Research)

Can you hear me?

Operator (participant)

Yeah, yeah.

Emily Field (Director, Head of European Pharmaceuticals Equity Research)

Sorry, I didn't get the pop-up. I didn't get the pop-up. I apologize. Sorry. I wanted to ask a question on flu vaccine. I know that you had previously guided, you know, for a down year, but that now expected to be down 20%. If you could give any color on what the driver is for that. I believe on the pipeline slides, you indicated that we could get an update on the go-forward plans for the mRNA seasonal flu vaccine. If you could just give any sort of high-level thoughts on what we could expect from that decision in the back half of this year. Thank you.

Emma Walmsley (CEO)

Okay. Thanks, Emily. I think you said on flu. I mean, as you know, our current flu business is in, let's call it, not the most modern technology platform. We are expecting a decline. I'll ask Luke briefly on why we see that. Once again, to reiterate, our overall outlook for vaccines remains very strong for the year. Perhaps, Tony, you can update. I know we're excited about the potential doublet pursuit that we can go on with mRNA. Luke.

Luke Miels (Chief Commercial Officer)

Sure. Thanks, Emma. Emily, thanks for your question. Basically, you've got a comparative issue as the demands around the time of COVID, of course, was very high, and so that's there's pressure there. The fact is there's a lot of doses around there, but people are very motivated to discount to offload them, so we're seeing pricing pressure. In terms of volumes, we expect around 43 million doses this year versus around 51 million that we sold in 2022. You know, our goal remains to evolve this technology, and I'll hand over to Tony.

Tony Wood (hief Scientific Officer, and President of Research and Development)

Yeah, first of all, Emily, as I said, we're now moving with the mRNA partnership and in flu and COVID into evaluation of multivalent options. We continue to be encouraged by the data that we see there, and that is a move into phase I and phase II studies we expect in the case of both instances, and we'll see readouts on those towards the end of the year at the beginning of next year. I think probably the only other thing I would add is that I'm sure you've followed this as well, that, you know, the field continues to encounter difficulties in flu with regards to coverage, particularly in B strains.

What I'd say at this point is that our studies are designed to account for B strain coverage and looking at a broader range of antigens. All of that will come together when we have an opportunity to update you in more detail at the beginning of next year.

Luke Miels (Chief Commercial Officer)

We're very pleased with progress in that form.

Emma Walmsley (CEO)

Thanks. Next question, please.

Operator (participant)

Our next question is from Peter Welford at Jefferies. Please, over to you, please, Peter.

Peter Welford (Senior Equity Analyst and European Pharmaceuticals Analyst)

Hi. Yes, thanks. I just wanted to come back, and apologies for this, but back to just U.S. Shingrix for a minute, just to try and understand the cadence here that we're talking about. I mean, presumably, the retail segment is typically the segment that we would anticipate to increase towards the end of the year. Just trying to understand in that segment, you're saying demand is still robust, but presumably we will see the usual sort of detailing that you do together with flu. Is there any sort of issue, I guess, with Arexvy perhaps taking over priority there going into the flu season for the retail channel this year? For the non-retail, just trying to understand. The issue is that there's a large...

The majority of the non-retail segment has yet to reach that 60%-65%. Is it, well, could you just talk about what is the challenge perhaps to get doctors there? Is it coverage or is it as insurance coverage, or is it just, you know, getting these people back in to see the physician? Well, what is it exactly that they're sort of receiving there with the doctors, please? Thank you.

Luke Miels (Chief Commercial Officer)

Sure. Peter, I'll start with non-retail first. We've had a couple of very, very large players that we've intensively worked with. As natural, when you've got momentum, you try and go with that. We really wanted to see how high the penetration we can get, and we still expect those large centers to keep vaccinating, and our aim is to go beyond 60%, but the curve does tend to flatten out at 60%. Now, if we think long term, this is why I'm personally fascinated with the relationship that we've seen in the Welsh study around vaccination and Shingrix and a potential relationship with dementia, and we're gonna be very busy with life cycle work on that one, both prospectively and retroactive retrospective analysis.

There are another 197 key customers that we have that are in the 30s, or a range from sort of the 30s to the 60s, that we are now putting more work behind. We also pulled back on the primary care promotion on Shingrix in these centers, and we're concentrating on Trelegy to give that a hard push along with Nucala as an experiment to see if PCPs would respond. We're now switching that team back to Shingrix, so that's all pointing in the right direction. It's more a case of prioritization, and just moving that up. These larger centers put a flag in the system, and we saw one was really moving. We just need to do the hard work to pick up the other ones. I feel very confident we can do that.

In terms of retail, you're right, there is, you know, there's still a seasonal relationship, we expect that to continue. It's not as extreme as it was in the first couple of years of Shingrix, it still exists. The unknowns are, there's no push on COVID booster this year, we don't know what effect that is. That has been a drag historically, as you correctly point out, we're gonna be very busy with Arexvy, targeting the high-risk individual, which is a subset of the Shingrix target universe. Let's see. We'll get some more color. I, unfortunately, don't have a crystal ball, I remain very confident about the demand for this product in the U.S. in 2023.

Emma Walmsley (CEO)

Just to remind everyone again, ex-U.S. and Germany, we're at less than 3% penetration. There is, you know, plenty of runway for this asset, and it's an asset that we are planning to add to. The next question, please.

Operator (participant)

Our next question comes from Eric Le Berrigaud at Stifel. Eric, over to you, please.

Eric Le Berrigaud (Managing Director, and Head of Healthcare Europe)

Yeah, thank you, Nick. Good afternoon, everyone. Just a question to get more clarity in terms of cash flow development. We're now getting in terms of earning growth into the double digits. You're raising the guidance here, but still guiding in terms of cash flow declining this year. Could you maybe give us a little bit more details about the push and pulls to make the difference between earning growth and cash flow decline? Even though we go beyond the Gilead settlement and the COVID impact, whether getting into 2024 and beyond, we might see cash flow development more in line with earnings. Thank you.

Emma Walmsley (CEO)

Thanks, Eric. Well, over to you, Julie, remember, we're reiterating our 2026 outlook for operating cash flow.

Luke Miels (Chief Commercial Officer)

Yeah. Thanks, Emma, very much. Thanks for the question, Eric. This year, clearly, we've had an influence of a number of factors with the cash flow. A couple of things happened last year that have obviously impacted the comparator. Last year with the cash flow, we had the Gilead settlement that occurred at the beginning of the year, we've also had X blantus receivables coming in last year. This year, the cash flow has been depressed somewhat, partly by movements in working capital which we expect to resolve by the end of the year. Also, we've had an additional pension payment that's been made this year, which was reasonably sizable, over GBP 350 million.

There are, you know, some, somewhat one-offs, you may call them, relating to the cash flow. This is why you see the 2 billion swing in the first half. We are maintaining the guidance for the full year for cash flow, which is basically to be slightly lower than last year. The major reason you do see this difference, usually our cash flow weighting is very much towards the second half. We normally have around 70%-75% of the cash coming in the second half of the year. Last year was very unusual. It was 50/50 because of the things I mentioned. That's why you're seeing the difference.

In terms of 2024, obviously, we'll guide, when we come to that at the end of the year. You can be sure that we will care for cash. We'll be very focused on cash conversion and the translation of profit into cash. You can see us paying a lot of attention to that as we go forward.

Emma Walmsley (CEO)

Right, thank you. Next question.

Operator (participant)

Can we get the next question from Michael Leuchten at UBS. Over to you, Michael.

Michael Leuchten (Managing Director, Head of European Pharmaceutical Research)

Thank you, Nick. Question RSV and Luke's comment on prioritization, please. I guess the ACIP recommendation could have been a little bit stronger than it was. Just wondering how you reacted to that. Will you throw more commercial resources at Arexvy, or is the plan executed as it was? Thank you.

Emma Walmsley (CEO)

Thanks. Well, I know Luke's very excited about this, about the pending launch, so, just add a bit of color to that.

Luke Miels (Chief Commercial Officer)

Sure. Look, I think on my Christmas wish list, it would have been for a simpler label, but that's the label we've got. I think to put it in perspective, our strategy has always been to focus on these high-risk individuals who naturally would engage in that type of discussion with their healthcare provider, are regular visitors to the pharmacy because they're polypharmacy. We have market research that clearly says that. If you look at our label, that secondary claims, the 94% efficacy, et cetera, really plays to our strength. I think at the end of the day, it doesn't have an enormous impact in the first couple of years. We are now actively, with Tony's team, generating the data that the ACIP group wants to see, and we're confident that we can bring that.

I think if we look in the medium to long term, we'll see this a fully supported, you know, simpler access process for these vaccines. Our discussions with insurers are very, very encouraging. There's also been some really good work published by our friends in New York, that looked at rates of RSV present in hospital setting, particularly if you use purine-based tests. They're looking at, you know, it's really an underdiagnosis by a factor of two. The demand is there, the willingness to recommend is there, so we remain encouraged, and the pricing, of course, is higher. I think we have to see the full effect in terms of the multi-season label. Again, for these high-risk patients, I think this is more of a reassurance.

Also, arguably, lets us move this out of the seasonal collar, that we would normally typically have with flu, because you've got that longer timeframe in terms of coverage. Net-net, I think we remain very excited, as Emma said. We're very much looking forward to the strategic battle, with Pfizer, and it's something that we relish, and in the end, this is gonna mean that, physicians and pharmacists are better informed, and patients are gonna get a better vaccine.

Emma Walmsley (CEO)

Great. Thank you. Next question, please.

Operator (participant)

Next question from Graham Parry at Bank of America. Graham, over to you, please.

Emma Walmsley (CEO)

Hi, Graham.

Graham Parry (Managing Director, and Head of Healthcare Equity Research)

Hi, thanks for taking the question. Actually, I just wanted to follow up on, I think a couple of people asked effectively if you can grow Shingrix in the U.S.. I'll just throw that to Alex. I think it's been answered, and then actually ask my question, which is on Zantac. With the Goetz settlement, you showed a willingness or even a desire to settle cases in California. Is that still the attitude that you have towards the upcoming case in November? Now, the same lead plaintiff's attorney is representing the plaintiffs both in California and the Delaware cases. Would any settlement of the entirety of the Zantac litigation now need to include a Delaware settlement as well? Thank you.

Emma Walmsley (CEO)

Thanks, Graham. Well, we'll come to Luke, see whether he wants to add anything more to his already reasonably comprehensive answers on the U.S. In terms of Zantac, look, we remain very confident in our position. We continue to be guided by the science, the evidence that's been in place. We've got a dedicated team managing this. We'll continue to defend ourselves vigorously. We obviously won't comment on our specific legal strategy ahead of its execution. Happy to be where we are, and we'll keep everybody updated as we progress through. Obviously, knowing that we've got Delaware coming in the new year, nothing more to add than that. Luke is shaking his head with nothing new to add on Shingrix. Back to you, Nick.

Operator (participant)

Thank you. Can we take the next question from Rajesh Kumar at HSBC, please?

Rajesh Kumar (Managing Director, and Head of Life Sciences and Healthcare Equity Research)

Hi there. Just on the capital allocation piece.

Emma Walmsley (CEO)

Yeah.

Rajesh Kumar (Managing Director, and Head of Life Sciences and Healthcare Equity Research)

You suggested that you're going to, you know, focus on deals as well as, you know, investing organically in R&D.

Emma Walmsley (CEO)

Yeah.

Rajesh Kumar (Managing Director, and Head of Life Sciences and Healthcare Equity Research)

Could you run us through some, you know, criteria you look at when you deploy capital, when you pick between R&D versus external investment, how do you compare the two? What are the internal metrics you look at? If the management, below the top management are incentivized similarly for doing deals versus organic investment?

Emma Walmsley (CEO)

I'll comment on that, and then, let's see if Julie wants to add anything further. It should be really clear in our capital allocation framework that our number 1 priority is investing in growth. As you saw, both from Julie's side and from Tony's side, that's about the pipeline and the launches. I mean, in the pipeline, it is organic and inorganic. I mean, you will know this across the entire sector, I think probably about half of the pipeline is sourced from outside. That number is probably going up across the sector.

You know, we've been really pleased with the reset of our balance sheet to create the capacity to do that, and have had a, you know, very focused track record of executing against deals at a reasonably swift pace, particularly over the last 18 months. You should expect to see more of the same. I think the most important point is because it's part of the way we do R&D, our BD team reports into Tony. We've been very thoughtful about the incentive system and the goals that are set in terms of pipeline progression to keep it neutral, regardless of whether it's sourced internally or externally. You're absolutely right. You can then there were some slightly perverse incentives around that, which aren't helpful.

Our criteria are unchanged, and I think were laid out explicitly on Tony's opening slide. We like to look for assets that are best in class, first in class. We look at ROIs, NPVs, we look at contribution to sales growth, particularly in the latter half of the decade and beyond. We look across the balanced portfolio of risk, across all therapeutic areas. We're obviously focused more on investing in our specialty and vaccines pipeline, but also in technology platforms that will allow us to continue to improve productivity. That's why we like to see the tech enablements of what we bring through. The really important point is that regardless of whether it's internal or external, regardless of TA, we use the same set of criteria.

I don't know if either Tony or Julie would like to add to that or?

Julie Brown (CFO and Executive Director)

Yeah, just an extra point. I think, I mean, we have got also a very rigorous governance process that runs through both BD assets. We get together regularly looking at the BD pipeline as well as the organic pipeline. As Emma mentioned, you know, one of our jobs we see as being very important is also to accelerate the key assets. We identify the key assets, we look to accelerate them. We look to ensure that they've got the right resources to do that, and that we remove any blocker that could be there in the organization. Finally, we also review assets, whether it be BD or organic, for success. We do post-deal reviews also. There's a very rigorous process around this.

Emma Walmsley (CEO)

Great. Thank you. Next question, please.

Operator (participant)

Next question from Richard Parkes at the BNP Paribas. Over to you, Richard.

Richard Parkes (Managing Director, and Head of Pharmaceutical and Biotechnology Equity Research)

Thanks, Nick. I just wanted to push you a little bit more to talk about your expectations for the RSV launch based on the initial outreach. I think with the need for boosters looking uncertain, I think the market's skeptical on your previous Shingrix-like target, given higher pricing, clearly it could be a more meaningful opportunity near term, if you can drive rapid uptake. Looking at consensus, I think you've got GBP 180 million of sales this year and growing to GBP 570 million next year. I just wondered if you could give us your thoughts on whether you see potential to exceed those numbers, or is the weaker ACIP recommendation and maybe lower vaccine uptake that you're factoring into flu vaccine going to be a headwind to that?

I know you've not upgraded the vaccines guidance despite that higher pricing, does that moderate your expectations in terms of volume? Thank you very much.

Emma Walmsley (CEO)

Thanks. First of all, I'll start, and then I'll come to Luke on any additional comments. There is absolutely no change to our outlook, which was reemphasized again, at our Meet the Management update on infectious diseases, that we see the potential of this to be around 3 billion GBP of sales. In that sense, it's a multi-billion asset. I think we've been clear right from the beginning that we didn't expect the start to be at the same rate as Shingrix, just for the simple factor of awareness of the disease. Of course, you've got some competitiveness for arm space in there.

Also, as you know, we had a very specific recommendations from ACIP for Shingrix, which was not unusual, as well as the bizarrely helpful initial shortage of supply, which we are a long way from dealing with here. We're also taking a different pace of launching in multiple countries across the world. We don't guide for individual quarters of sales. Luke will likely comment on some more details around the price sets as well.

Luke Miels (Chief Commercial Officer)

Yeah. Thanks, Richard. I mean, I think, you know, there was no solution for RSV historically, so it didn't really make a lot of sense for systems to focus on. As you saw COVID with PCR testing, often that was an accompanying test and better understanding of the character and prevalence of RSV emerged. I think we're in a very different place than we were, say, a couple of years ago. As we start to promote it and educate doctors and pharmacists, and pharmacists chains are very enthusiastic about this product, I think that's a very fair long-term ambition. There's a heavy overlap with if you look at high-dose flu, and of course, the Shingrix population and the pneumococcal population.

I've said in the past that I think there'll be a steady build, but the peak will be very strong. This is outstanding data for something that's very, you know, impactful to healthcare systems and individuals. I think we'll get there. The data that we've generated so far is quite exciting. Pricing-wise, again, you know, we went into ACIP with a core of $270-$295, and we've been able to keep within that at $280. I think our credibility with ACIP has enhanced through that process, and the reception we've received so far from payers and pharmacy chains has been very encouraging. That's probably all I can say at this point. I very much look forward to updating everyone in Q3.

Emma Walmsley (CEO)

Wonderful. Thanks, Luke.

Operator (participant)

Next question is from Andrew Baum from Citi. Over to you, Andrew.

Andrew Baum (Managing Director, and Head of Global Healthcare Equity Research)

Many thanks. In relation to Trelegy, we're expecting it to be included in the IRA price negotiation list being enacted in 2027. I'm curious as to how Luke is thinking about the ability of GSK to claw back the rebate in order to mitigate the impact of the list price reduction. My understanding is that PBMs cannot exclude a drug once it's been selected for price negotiations. Do you think you can take away the rebates, or do you think that the PBMs will make you pay by creating hurdles to other products in your portfolio? Just following up on an earlier question, in relation to the impact of the out-of-pocket cap in driving increased volumes. To what extent do you think? Because still the patients are going to have to pay $2,000 out of their own pocket.

How meaningful do you think that really is in getting patients off your patient assistance program onto pay drugs? Do you actually think $2,000 is still a real barrier for many patients, and therefore, the volume impact isn't going to be that meaningful? Thank you.

Luke Miels (Chief Commercial Officer)

Andrew, I think $2,000 is still a large amount of money for many people, particularly older individuals. It's an improvement. It's more predictable for those patients. I don't see a massive adjustment in some of our assistance programs, particularly in oncology and areas like that. In terms of Trelegy, I mean, Q4 this year, we'll have a better idea in terms of how CMS is defining those first, you know, Part D drugs, and how it's going to be managed. We have, as you said, high, very high RAI rates on Trelegy already. I think PBMs are probably your second scenario is more likely to be reality.

I think we'd be, you know, we're very rational to make that assumption. We're obviously starting to think about various combinations and initiating discussions with them. I think the other factor with Trelegy is whether you'll see a generic emerge at some point, because the technical challenges that we've come to see on closing three inhaled medicines and validating that for a regulatory path is not simple, as we've seen with Advair. I think that's also another factor which we're starting to look at.

Emma Walmsley (CEO)

Great. Thanks. Nick?

Operator (participant)

Yeah. Please take the next question from Kerry Holford at Berenberg. Over to you, Kerry.

Kerry Holford (Managing Director, and Senior Equity Research Analyst)

Hi. Thank you, Nick. Question is for Deborah on long-acting HIV. Clearly Cabenuva, strong performance in Q2. Just whether you can talk to that. Was that growth in this quarter truly reflective of underlying demand, or are there anyone else to be aware of when we're modeling sales in the second half of this year and beyond? You also highlighted that together, two drug regimens, long-acting, represents, I think you said, around 50% of total ViiV. Interested to see whether that run rate at this point is what you would have expected from the long-acting portfolio, in particular, are you behind, in line, or ahead of those internal expectations at this point in the year? Can I squeeze in a quick one just to remind us of the timelines for your 3-monthly dosing formulation? Thank you.

Emma Walmsley (CEO)

Thanks, Kerry. Obviously, we're extremely pleased with the performance of ViiV this year and to be able to upgrade our outlooks on it, and not least because of the innovation that we pioneered on coming through so strongly. Deborah, do you want to pick up on those?

Deborah Waterhouse (President of Global Health)

Yeah. Thanks for the question, Kerry. Needless to say, we're really pleased with the performance of our HIV business in the quarter. Really strong underlying growth for both our oral two-drug regimens and our long-acting injectables, and that is absolutely being driven by demand. Let's go into Cabenuva. It's all demand. We've seen really positive demand for our products from people who are living with HIV, and we know this is set to continue because we know that many doctor's offices have got people on waiting lists, particularly in the U.S., to be started on the drug. It's a really strong underlying demand from people living with HIV, and expect that to continue.

This, in turn, gives us confidence that, you know, we can build this market and can, you know, deliver greater and greater share of this market through our long-acting injectables. In terms of expectation, it's ahead of where we expected, if I'm completely honest. To be at 51% of our overall portfolio in our oral two-drug regimens and long-acting injectables is ahead of expectation. We're really delighted by the underlying demand, and particularly the long-acting injectable uptake from Cabenuva. It takes a long time to build a market, and you're in this market on your own, so, you know, you always wonder, how much will it take? Can you reach each stage of the journey, each barrier that you face? Actually, the answer is yes, we can. We're really optimistic, really optimistic about this opportunity.

In terms of the pipeline, I mean, we'll talk more about this at the Meet the Management session in September, but you know, what we've said is that, you know, we're looking to target an ultra-long-acting version of cabotegravir, so an ultra-long-acting every 3 months+, from 2027 onwards. We're making really good progress with our reformulation of cabotegravir, because that's going to be the backbone to the first wave of our innovation in PrEP and in treatment. What you've probably seen on some of the slides that Tony presented was us starting to move forward the accompanying partners, be it maturation inhibitor, be it Captid, or be it Albinam. We're kind of moving those assets forward so that we can make a choice in 2024 of the regimen that we will take forward.

The date that we've given in our previous investor update stands, but we hope to be able to give you a little more specificity when we do the Meet the Management in September. Very optimistic, you know, positioned to be in both from a pipeline and a performance perspective, in the HIV space.

Emma Walmsley (CEO)

Great. Thanks, Deborah. Well, I gather there are still a few handful more questions, so we'll keep going and try and give us some short answers. Speaking for myself. Nick.

Luke Miels (Chief Commercial Officer)

Oh, yes. Just one correction or one clarification. The patent expiry or LOE for Trelegy is 2027, but where I remember having it back is 2028. Just want to make sure everyone's clear on that.

Emma Walmsley (CEO)

Great. Thank you.

Operator (participant)

Yeah. Simon Baker, over to you, please at Redburn.

Simon Baker (Partner, and Head of Global Biopharma Research)

Thank you, Nick. Good afternoon, everyone, thanks for taking the question. Going back, Tony, to Slide 13 on R&D. Two related questions, so 1 really. Firstly, on the reduced cycle times, could you give us some idea of how much of that is down to therapeutic mix and how much is underlying reduction in non-vaccine R&D times? Also on the probability trend, you show a nice trend of improvement in phase II, III, and beyond probabilities of success. Normally, that is matched by a reduction in success rates in phase I, i.e., you are killing projects earlier. I wonder if you could give us an idea how that trend has evolved over time. Thanks so much.

Emma Walmsley (CEO)

Thanks. Great. Tony, now clear focus for you.

Luke Miels (Chief Commercial Officer)

Yeah. Dotting down both questions, sign, I forget. In terms of your first question with regards to cycle times and obviously, there's a component of vaccines in that. We are seeing cycle times coming down, particularly across our late-stage portfolio, so a contribution from both. In terms of success rates in phase II, of course, what we want to do throughout the portfolio is begin to take attrition earlier and earlier. One of the things that we're driving, coming from our focus in human genetics and functional genomics, and of course, the benefits that we get in focusing in infectious diseases, is to be able to take the attrition on an efficacy terms much earlier than first time in humans.

I'm expecting that, or rather, what we'll see for the future, is those preservation of phase two success rates and it being accounted for by earlier attrition than that necessarily in first time in human. We're very much likely more focused on the quality of agents driving survival in that stage.

Emma Walmsley (CEO)

Thanks. Next question, please.

Operator (participant)

Next question from Emmanuel Papadakis at Deutsche Bank. Over to you, Emmanuel.

Emmanuel Papadakis (Managing Director, and Pan-European Pharmaceuticals Equity Research Analyst)

Thank you, sir. Perhaps just a quick follow-up. I think, Luke, you said the... In response to the earlier question around rebates, offsetting price negotiation, you said the second scenario. Could you just clarify what you meant by that? I.e., do you mean you think you will be able to reduce rebating to offset that price reduction? The question I wanted to ask was just on momelotinib, the delay in the PDUFA, to what extent do you think any bolus will now be diminished in demand by the delay, given the emerging data we've seen on anemia benefit with pacritinib, and to what extent, indeed, then is pacritinib's quarterly run rate of $20 million or so actually a better guide to how we should be thinking about the launch? Thank you.

Emma Walmsley (CEO)

Next question.

Luke Miels (Chief Commercial Officer)

Sure, Emmanuel. I just think we're gonna have pressure, and it's going to be difficult to evade those scratches, which I think is my understanding of Andrew's 2 options. I would expect a high pain scenario versus a low pain scenario with traffic in terms of linkage to other products in the portfolio. Again, we're looking at options to offset that. I think that, yeah, we're making good progress there. In terms of momelotinib, I think the bolus will still be there. It's really interesting. Some of the recent market research we got is quite encouraging. I mean, some of the numbers, just for interest, I mean, 75% of doctors agree that fulfills an unmet need. This was quite interesting.

Around 60% of patients present with anemia within one year of diagnosis, about 46 need a transfusion. The other interesting statistic, which fits our strategy, is about two-thirds of them are on that 10-5 milligram dose of ruxolitinib. In terms of pacritinib, I don't think it's an accurate analog, because really, their label is within that platelet subgroup versus the broader anemia group. There has been some, obviously, some great posters, et cetera, presented. The NCCN guidelines, if you look at the minutes, they declined to review that broader recommendation. That product is very much anchored in a low, you know, below 50 platelet group, whereas we have a much broader opportunity, we believe, with anemia patients.

We'll wait to see what the FDA ultimately decides in terms of the label. We've built the business case for the deal on a second-line label, second-line anemia. Hope that helps.

Emma Walmsley (CEO)

I think last question, do we have?

Operator (participant)

Last question. Over to Steve Scala at Cowen. Steve, over to you, please.

Steve Scala (Managing Director, and Senior Health Care of Major Pharmaceuticals Research Analyst)

Oh, thank you. Can you hear me?

Emma Walmsley (CEO)

We can.

Steve Scala (Managing Director, and Senior Health Care of Major Pharmaceuticals Research Analyst)

Okay, thank you. In adult RSV, how has your success in contracting thus far compared to your expectations and versus what you think Pfizer has accomplished to date? Is your potentially superior data giving you the edge versus Pfizer, and if not, then why do you think that's the case? Thank you very much.

Emma Walmsley (CEO)

In recognition that we are in a competitive commercial situation, I'll let Luke answer the final question. Thanks, Luke.

Luke Miels (Chief Commercial Officer)

Steve, we are encouraged. It's happening right now, so literally as we speak. We'll have more news for you in Q3, hopefully the good news.

Emma Walmsley (CEO)

Great.

Luke Miels (Chief Commercial Officer)

Sorry, I can't tell you more.

Emma Walmsley (CEO)

Thanks, Luke. Well, once again, thanks everyone for joining us. We've been very pleased to report another excellent quarter of performance with strong sales and earnings growth, driven by new product sales, known as BNHIV and vaccines, ongoing progress in our pipeline, the approval of the world's first RSV vaccine, closure of our BELLUS Health deal, of course, upgrading guidance. With this momentum behind us, a lot of confidence in delivering our short, medium, and long-term targets. We really look forward to keeping you informed over the course of the head. Thanks, all. Bye.