葛蘭素史克 (GSK) 2024 Q2 法說會逐字稿

Hello, everyone.

Welcome to today's call and webcast.

The presentation was sent to our distribution list by email today, and you can also find it on gsk.com. Please turn to Slide 2.

This is the usual Safe Harbor statements will comment on our performance using constant exchange rates or CR, unless stated otherwise.

Please turn to slide 3.

Today's call will last approximately one hour with the presentation taking around 35 minutes and the remaining time for your questions.

Today, our speakers are all Emma Walmsley, Tony Woods, Luke Miels, Deborah Waterhouse, and Julie Brown with David Redfern joining for Q&A.

Please ask one to two questions so that everyone has a chance to participate.

Turning to Slide 4.

I will now hand the call over to Emma.

Welcome to everyone joining us today.

Please turn to the next slide.

I am delighted to report that GSK's momentum this year continues with excellent second quarter performance.

Sales grew 13% to GBP7.9 billion.

Core operating profit was up 21% to GBP2.5 billion, and core earnings per share rose 17% to 43.4p, all excluding COVID solutions.

This reflects our continued focus on operational execution and the strength of GSK's broad portfolio yet to prevent and treat disease.

Sales growth was reported across all three product areas for the first half.

For the second quarter, vaccine growth was driven by international expansion, specialty medicines in particular were up strongly growing over 20%, reflecting successful new launches of Ojjaara in myelofibrosis, Jemperli in endometrial cancer, and long acting HIV treatments.

And we also delivered a record quarter for Trelegy in general medicines.

All of this demonstrates the strength and breadth of our portfolio to deliver competitive and profitable long-term growth.

This strong sales performance has been underpinned by expected cost control, driving operating leverage and further margin improvements this year.

And these benefits are also delivering improved operational cash flow, providing funds for pipeline investments as well as returns to shareholders.

Our dividend for the quarter was 15p.

And on the basis of our current performance and prospects, we are again upgrading our full year guidance.

Next slide, please.

We continue to invest in the pipeline and are making good progress.

This quarter GSK's long-standing expertise and leadership in respiratory will once again reinforce with positive Phase 3 data reported for depemokimab.

In oncology, we continue to progress material growth opportunities, most notably the presentation of positive second line combination data for Blenrep to treat multiple myeloma.

In vaccine, the Arexvy was first again with the approval by the FDA to prevent RSV disease in adults aged 50 to 59 who are at increased risks, although ACIP postponed recommendations for this cohort was surprising, we have to remember this is a brand new vaccine.

We look forward to sharing additional data requested and more and remain very confident that the benefit Arexvy can offer to this age group like other cohorts, will be fully recognized and that this best-in-class vaccine will reach its full sales potential.

I'm also delighted that we've taken steps forward in clinical development for our pioneering ultra long-acting HIV medicines of potential functional cure treatment for Hep B and our novel antibiotic, gepotidacin.

Next slide, please.

Building trust by delivering across the six key areas we've prioritized ESG, it remains a clear priority for all of us at GSK.

Earlier this month in partnership with Medicines for Malaria Venture, we launched tafenoquine in Thailand and Brazil.

This is the first single dose radical cure medicine to prevent malaria relapse, another step forward to eliminating this disease.

In May, we became a founding partner of the Fleming Initiative, a new global network that brings together scientists, policymakers, and the public to fight antimicrobial resistance.

And we've also started a Phase 3 trial for low carbon version of our metered dose inhaler, Ventolin, using a last generation propellant, our inhaler has the potential to reduce emissions by around 90% versus the current one and benefit millions of people with asthma.

Please turn to slide 8.

So I am delighted with GSK's continued progress on strengthening prospects.

But before reminding you of these, a quick word on Zantac, given the ruling we have of miscibility of evidence this quarter.

This type of ruling in Delaware does not determine liability and our position remains unchanged.

We will continue to defend against the claims being made and our aim as it has been all along is to manage this in the best interest of the company and shareholders and to stay focused on our delivery.

As many of you know, we started this year by setting out new upgraded, long-term commitments, and we're all focused on delivering against all of these short, medium, and long term.

With our current momentum and the continued progress we're making, we have today upgraded our outlook for 2024, demonstrating the strength and the depth and breadth of our portfolio.

We now expect to deliver sales growth of 79% and core operating profit growth of 11% to 13%, with a short-term shift in mix that the team will comment on.

For 2026, we continue to expect more than 7% sales growth and more than 11% core operating profit growth on a five-year [CAGR] basis.

And for 2031, we continue to expect sales of more than GBP38 billion with a broadly stable margin through the loss of exclusivity of dolutegravir.

And remember, these outlooks do not yet include the launch of Blenrep or ongoing progress in our earlier-stage pipeline.

So I'm now going to hand over to Tony to talk you through our R&D progress in more detail.

Thank you, Emma, and welcome, everybody.

Next slide, please.

As you know, our approach in R&D is to invest for growth in new best-in-class vaccines and medicines, combining our scientific focus on the immune system with the use of advanced technologies.

Today, our pipeline comprises 70 assets in clinical development and my priority remains the acceleration of the delivery of new vaccines and medicines for patients and to drive future growth for GSK.

In the past six months, we secured regulatory approvals or received acceptance of submissions for 10 major medicines and vaccines and reported positive data from seven Phase 3 studies, clearly demonstrating the innovation and health impact that GSK is now bringing to patients.

Focused business development has continued as well.

We strengthened our respiratory pipeline with the acquisition of Aiolos Bio for their long acting TSLP antibody anticipated to start Phase 2 in 2025, and we gained full control of our candidate mRNA vaccines by restructuring our collaboration with CureVac.

Accompanying these were investments in two new technology platforms, the acquisition of Elsie Biotechnologies, which will help accelerate our oligonucleotide program and an agreement with Ochre Bio that will create foundational liver biology datasets, deepening our understanding of disease and improving target identification.

In all, we've advanced the pipeline across all our core therapeutic areas.

And importantly, we're on track with the development of the 12 scale product opportunities as well as Blenrep that we highlighted at the start of the year.

These all have the potential to deliver profitable growth in the 2026 to 2031 time frame and to support our 2031 ambition of more than GBP38 billion in sales.

I'll now take a closer look at a few important areas.

Next slide, please.

First, in vaccines, where preventing seasonal viral and high-risk bacterial diseases remains a key focus for us.

We have an extensive development plan for Arexvy and continue to see this exceptional vaccine as a major long-term growth opportunity.

Arexvy is the world's first RSV vaccine and has demonstrated outstanding efficacy in adults of various ages, including more than 94% during the first season for people with co-morbidities and who had increased risk of severe RSV disease.

In June, ACIP recommended use of Arexvy for all adults aged 75 and over and for adults age 60 to 74 who had increased risk from severe RSV disease.

The committee unexpectedly postponed a vote in adults aged 50 to 59 requesting additional data.

These include evidence from vaccine surveillance databases to further support the benefit risk profile observed during clinical trials in a real-world setting.

We look forward to contributing to these data over the coming months.

I'm also looking forward to the data from studies, 006 and 004, assessing efficacy, immunogenicity, and safety of Arexvy over three RSV seasons.

These data will be important to help answer the questions raised by ACIP on outcomes and duration of protection.

As a reminder, season two data showed 75% cumulative vaccine efficacy against severe lower respiratory tract disease over 23.3 months.

These data support the strong and durable protection that this uniquely adjuvanted vaccine offers against RSV.

Later this year, we're also looking forward to sharing more from trials in adults aged 18 to 49 who are at increased risk from RSV disease.

Next slide, please.

Next, a comment on the interesting data for Shingrix we shared yesterday at the Alzheimer's Association International Conference in Philadelphia.

These data add to the growing body of evidence exploring the observed association between shingles vaccination and the reduced risk of dementia.

Our study was prompted by a number of observations, some of which are summarized on this slide.

There's a growing body of evidence largely generated from retrospective case studies in very large populations that Herpes Zoster vaccination is associated with a reduction in the diagnosis or onset of dementia.

These data include a recent observational study in Wales, which concluded that vaccination with a live attenuated Herpes Zoster vaccine was associated with a 20% reduction in dementia diagnosis when compared to people who did not receive the vaccine.

Using an AIML approach and data from Optum's electronic health record data set, we constructed a retrospective observational study comparing matched cohorts of adults vaccinated with Shingrix, our competitor live attenuated shingles vaccine and the comparative pneumococcal vaccine.

Headline data shown on the right hand side of this slide suggested after three years, Shingrix was associated with a 27% reduced risk of acquiring dementia when compared with the competitors' Zoster vaccination and a 24% reduced risk of dementia when compared to the comparative pneumococcal vaccine.

The potential relationship between shingles prevention and risk of neurodegeneration is an area of increasing interest for the scientific community.

These are interesting, early results, which we are investigating with additional retrospective and mechanistic studies.

Next slide, please.

Turning now to respiratory.

We're making good progress with novel treatments that could provide more effective options for severe asthma, COPD, and refractory chronic cough death.

Depemokimab is the first ultra long-acting biologic engineered to have high affinity for IL-5.

It enables sustained inhibition of Type 2 inflammation with twice yearly dosing versus current options, some of which require injections every two weeks.

This quarter, we announced the two pivotal Phase 3 trials in severe asthma with an eosinophilic phenotype, SWIFT-1 and SWIFT-2 met their primary endpoints, demonstrating the two doses of depemokimab administered over a 12-month period showed a statistically significant and clinically meaningful reduction in significant exacerbations versus placebo in combination with standard of care.

We're looking forward to sharing full data at the ERS conference in September, and we remain on track to file the medicine for approval later this year.

Depemokimab's development program is being informed by predictive biomarkers and phenotyping, which has enabled us to progress four clinical indications in parallel.

The pivotal ANCHOR-1 and 2 trials in one of these chronic rhinosinusitis with nasal polyps are now closed for recruitment with data expected later this year.

We also expect to see Phase 3 data on the use of Nucala in COPD this year and Phase 3 data for camlipixant in the treatment of refractory chronic cough in 2025.

Next slide, please.

You will shortly hear from Deborah on the important advances in our HIV pipeline.

So I'll conclude with a brief summary of the strong progress we've made within the oncology portfolio during the first half.

We're building an emerging and high potential portfolio of new medicines, with a growing focus on ADCs, immuno-oncology, and targeted small molecules.

For Blenrep pivotal data from the DREAMM-7 and DREAMM-8 studies presented at ASCO demonstrate the potential for Blenrep to become the new standard of care for patients with multiple myeloma in the second line setting.

These trials will serve as the basis for regulatory submissions, and we're pleased that EMA recently accepted our first filing for this indication.

Additional filings are planned before the end of the year.

Also stated at the recent Meet the Management event, we plan to start a Phase 3 trial in the first-line setting in early 2025.

For Jemperli, recent data from the RUBY trials demonstrated a statistically significant overall survival benefit in an all-comer population with primary advanced or recurrent endometrial cancer.

Jemperli is the only immune-oncology agent to demonstrate a survival benefit in this patient population.

These data have been filed with the FDA, and we anticipate a response ahead of the August 23 PDUFA date.

Carefully targeted Phase 3 trials investigating the use of Jemperli in the treatment of rectal, lung, and head and neck cancers are also ongoing.

The first half of 2024 also saw a number of oncology indication trial starts, including GALAXIES-301, a Phase 3 trial investigating our TIGIT antibody, belrestotug in combination with Jemperli in the treatment of first-line PD-L1 high non-small cell lung cancer.

The glio-focused Phase 3 study, which will investigate Zejula in the treatment of newly diagnosed glioblastoma and a Phase 1 study of B7 H4 ADC; GSK '584, which recently entered the clinic.

We're looking forward to seeing more data from our ADCs by the end of the year to inform pathways for accelerated registrations.

Finally, we're pleased to announce the recent Japanese approval of Omjjara with a line agnostic label for all patients with myelofibrosis.

So in summary, a productive first six months to 2024, I'm pleased with the progress we're making to deliver differentiated health impact for people and patients.

And I'll now hand over to Luke.

Thanks, Tony.

Please turn to the next slide.

In Q2, we delivered growth across all our product areas and regions with GBP7.9 billion of sales, up 13% versus last year, excluding COVID solutions.

This includes another strong performance in the US with growth of 17%.

Please turn to slide 17.

Vaccine sales grew 3% in Q2, excluding COVID solutions.

This performance was impacted by short-term factors, and we fully expect the underlying strength of the business to continue over the long term.

Globally, Shingrix grew 7% year to date, but was down 4% in the quarter, delivering GBP832 million.

Outside the US, sales grew significantly and represented 64% of Q2 revenue.

Shingrix is now launched in 45 markets, the majority with less than 5% penetration.

And these markets represent our source of future growth for this vaccine.

Q2 growth was driven by national immunization program in Australia, expanded European public funding, and supplied to China.

Supply phasing to China is now expected to be delivered evenly across the second half, with 40% of our agreed full year supply delivered to date.

In the US, sales decreased by 36% in the quarter due to three factors.

The first, channel inventory reductions, and secondly, important changes in retail banks and privatization in part due to a transition to a new CMS rule effective the January 1, '24 that changed our pharmacies' process, reimbursements, and payers.

These two short-term effects are not expected to repeat in the second half of this year.

And thirdly, lower demand driven by challenges activating harder to reach consumers addressing this remained a priority with cumulative penetration of people aged 50 and older reaching 37%, up 6 points since the same time in '23 based on latest census data.

With more than 70 million adults that are still unvaccinated are recommended to receive a vaccine, we're focusing our resources and marketing content on targeting these eligible potential patients.

Our expectation continues to be that Shingrix global sales will grow this year and reach more than GBP4 billion by 2026, driven by growth outside the US.

Turning to RSV, nearly 8 million people have been vaccinated with Arexvy since launch, and we are maintaining around two-thirds of the retail vaccination share.

As expected, demand levels were lower in Q2 due to seasonality.

Ahead of the 2024-2025 RSV season, we're well-positioned in our contracting and still expect blockbuster level sales in 2024.

These sales are expected to be second-half weighted with the vast majority in the US.

And following the recent ACIP recommendation, we received a universal recommendation in 75-plus year olds, but now expect minimal sales in the 50 to 59 age group this year with further potential impact in those aged 60 to 74 years.

Preparation for launches in Europe and international are underway for 2025 and beyond.

With a best-in-class data profile, we're confident Arexvy will return to growth next year and longer term can achieve more than GBP3 billion in peak year sales.

In meningitis Q2 sales of Bexsero and Menveo are up 23% and 30%, respectively.

Bexsero continues to demonstrate strong growth, benefiting from favorable pricing in the US, recommendation in Germany, and increased demand from Australian immunization programs.

Menveo grew due to favorable delivery timing in international markets and US CDC purchasing patents, including our candidate, [MenABCWY] vaccine, our meningitis portfolio is expected to deliver around GBP2 billion in peak sales.

Given the first half performance and our latest expectations with a tough comparative for Arexvy and US Shingrix in the second half, we now anticipate vaccine sales in the full year to increase by low to mid-single digit percent.

Our increased 2026 CAGR outlook for vaccines of low double digits has not changed.

Next slide, please.

In specialty medicines, including HIV, which Deborah will cover next, we had a very strong quarter and increased sales by 22% excluding COVID solutions and our expectations for the year, I'm pleased to say, have increased.

Nucala was up 17%, driven by higher patient demand for treatments addressing eosinophilic-led disease market expansion and increased buyer penetration.

Benlysta was up 20% in the quarter, driven by bio penetration growth from early intervention in SLE and lupus nephritis.

We're also seeing growing demand in the US and continued consecutive double digit growth outside the US.

In oncology, sales, again, more than doubled in the quarter.

In hematology, we're continuing to see a strong uptake for Ojjaara, which launched in the US last year.

And in the UK and Germany in Q1.

In gynecological cancers, continued momentum was primarily driven by sales in the US, Germany, France, and the UK in the first line, dMMR/MSI-high primary advanced or recurrent endometrial cancer.

In addition to growth from second line and later treatment.

Jemperli is the backbone of our immuno-oncology development and pending regulatory decisions and development beyond dMMR through consumers, which will drive future growth.

Zejula's growth continued in Q2 driven by the US and volume growth globally.

And as a reminder, for the next quarter, we will not benefit from the stocking of the older switch to the new tablet formulation as seen in Q3 '23.

Given the 21% sales growth in the first half, we're increasing our full year expectations and we now expect specialty medicines to grow mid to high teen percent with the second half growth being lower due to tougher comparisons in oncology.

Please turn to slide 19.

Focusing on Nucala for a moment.

The chart on the left of this slide demonstrates Nucala's continued leadership in IL-5 market share and I'm pleased to say that Nucala continues to grow by double digits quarter on quarter, despite being on the market for almost nine years.

We anticipate IL-5 portfolio comprising of depemokimab and Nucala to deliver more than GBP4 billion in peak year sales.

Next, looking at Ojjaara, we're still seeing the fastest US launch uptake in value for a JAK inhibitor in myelofibrosis.

So the only treatment to demonstrate clinical and durable benefit on spleen response symptoms and anemia for myelofibrosis patients with anemia, we're finding anemia burden to be increasingly at the forefront of treatment decisions.

We continue to improve our market share. 65% of US and EU healthcare professionals expect to increase prescribing Ojjaara in the next six months.

Please turn to slide 20.

Finally, general medicines grew by 12% in Q2, reflecting a record quarter for Trelegy, with sales increasing 41% to GBP842 million.

Around half of the growth was driven by channel and segment mix as well as adjustments to returns and rebates, which we expected to moderate in half two.

Trelegy also benefited from share gains and remains a top-selling brand in asthma and COPD and is the most prescribed single inhaler triple therapy worldwide.

Removal of the AMP Cap on Medicaid drug process in the US had expected impacted branded versions of Advair, Flovent, and Lamictal.

However, increased use of authorized generic versions of Advair and Flovent offsets this impact in the quarter.

Given the strong start to the year, we now expect general medicine sales to increase low to mid-single digit percent for the full year.

I'll now hand over to Deborah to cover HIV.

Thank you, Luke.

Next slide, please.

We're pleased to see continued strong performance and sustained double-digit growth in Q2, delivering 13% revenue growth.

Our growth is driven by continued strong patient demand for our industry-leading medicines, which has led to an increase of 2 percentage points in global market share versus Q2 2023.

Our oral two drug regimens and long acting injectables continue to transform the HIV marketplace.

Dovato delivered sales of GBP551 million in the quarter.

The strong body of clinical data and real-world evidence reinforcing the efficacy and durability of this medicine continues to grow.

At the International AIDS Conference last week, results of the PASO DOBLE study, a large head-to-head randomized clinical trial of Dovato compared against the three drug regimen, Biktarvy showed non-inferior efficacy and significantly less weight gain.

This is important because we know people living with HIV are concerned about taking more medicines as they age as well as the long-term risk of metabolic diseases that can come with weight gain.

Our long-acting portfolio also continues to perform strongly, delivering more than 50% of total HIV growth.

Cabenuva grew 42%, driven by patient preference and proven and durable efficacy.

[CASM] LATITUDE data presented at CROI and data from real-world cohorts that include over 10,000 people living with HIV in diverse settings has resonated strongly with physicians and has supported increased breadth and depth of prescribing.

Apretude grew more than 100% in the quarter.

This medicine has demonstrated proven superior efficacy compared with daily orals and a positive safety profile and high patient preference.

As a reminder, the registrational HPTN 084 study of PrEP in women was the first to show zero infections in participants who received injections as described per protocol.

We believe that long-acting therapies are the future of HIV care, empowering people impacted by HIV with choice and addressing the barriers standing in the way of reaching the end of the HIV epidemic.

Looking at the long-acting market, we can see that the treatment market is currently approximately 10 times larger than the PrEP market at about GBP20 billion, which will have a significant impact on the sales potential for long-acting options.

In the long acting injectable treatment setting, there are no competitor launches planned before 2028.

We continue to see strong progress across our pipeline.

At the AIDS Congress, we shared first time in-human data for our third-generation integrase inhibitor, VH184, demonstrating strong efficacy and a unique resistance profile.

Building on our strong legacy of developing powerful integrase inhibitors, these positive findings reinforce that integrase inhibitors will remain the gold standard in HIV, trusted for the efficacy, long-term tolerability and high barrier to resistance, and make VH184 an excellent candidate for further development for both ultra-long acting and self-administered therapies.

In PrEP, we have committed to move forward with our registrational studies for cabotegravir ultra-long acting Q4M with confidence in the efficacy and safety profile.

In treatment we've selected rilpivirine as a partner for cabotegravir ultra-long acting Q4M.

This regimen selection is based on progress in formulation studies for rilpivirine and builds on existing positive patient and physician experience with these medicines in our current portfolio.

We remain on track to deliver the first ultra-long acting four monthly treatment regimen in 2027 and four monthly dosing options for prevention in 2026.

We continue to progress our ambition of extending the dosing interval of our long acting regimens to enable every six months dosing towards the end of the decade.

Our strong performance over the first half gives us confidence to increase our guidance to low double-digit percentage growth in 2024.

With that, I will hand to Julie.

Thank you, Deborah, and good afternoon, everyone.

Next slide, please.

Starting with the income statement for the second quarter with growth rate stated in CER, sales increased 13%, as Emma mentioned, reflecting continued strong business performance, particularly within oncology, HIV, and Trelegy within general medicines.

Core operating profit grew 21% excluding COVID and 18% overall.

Operating profit grew ahead of sales as we continue to focus on disciplined resource deployment and delivery of a competitive P&L.

Core EPS grew 17% excluding COVID.

Turning to the total results.

Operating profit decreased 22% to GBP1.6 billion, predominantly reflecting charges arising from the CCLs, primarily due to improved longer longer-term prospects of our HIV business and less favorable foreign currency movements.

Next slide, please.

Moving to the core operating margin.

This increased 190 basis points to 31.9% year on year excluding COVID.

This reflected cost discipline, the drive of productivity improvements, and targeting resources to the key commercial and R&D assets in the business.

In addition, the gross margin benefited from positive regional mix.

These factors were partly offset by the impact of the loss of Gardasil royalties, as guided.

In the first half, we saw a significant margin improvement of 380 basis points at CER to 32.5%, with strong operating leverage underpinned by 13% sales growth, gross margin mix benefits, and a one-off favorable impact relating to this Zejula royalty dispute.

Next slide, please.

Cash generated from operations in the first half was GBP2.8 billion, representing an improvement of GBP0.9 billion versus half one last year.

This was primarily driven by core operating profit growth and favorable working capital, with the latter benefiting from higher receivable collections.

Free cash flow was GBP0.6 billion relative to an outflow last year and therefore improving year on year by almost GBP1 billion.

As usual, we expect to generate the majority of our free cash flow in the second half of the year, given the seasonality of the vaccine business.

Next slide, please.

Slide 26 shows our net debt position since the December 31, and how we've actively deployed capital in the business in line with our capital allocation framework.

Net debt was GBP1.1 billion lower compared to the end of 2023 at GBP14 billion, and this included the monetization of our remaining stake in Haleon.

We have a strong balance sheet to support continued investment in future growth, including business development as we look to deploy funds to enhance growth and deliver attractive shareholder returns.

And now with that, I'll turn to our latest full year expectations.

Next slide, please.

Given our strong start to the year and continued momentum, we are pleased to upgrade our 2024 guidance today.

You heard Luke and Deborah refer to our updated product guidance.

And in summary, the strong upgrades to specialty care and general medicines more than offset our lower expectations for vaccines this year.

In aggregate, for full year 2024, we now expect group sales to increase between 7% and 9% and core operating profit to increase between 11% and 13%, notwithstanding the loss of Gardasil royalties, which will reduce profit growth this year by 6 percentage points.

Turning to the P&L, the gross margin has been strong in the first half.

In the second half, we expect to incur costs to drive future supply chain efficiencies as well as lower positive mix benefits, given the phasing of the launches last year.

In addition, we continue to expect SG&A to grow at a low single-digit percentage, and we now expect R&D spend to increase slightly below sales growth and royalties for the year to be around GBP600 million.

Core EPS is expected to grow 10% to 12% due to an increase in the tax rate under OECD legislation.

I am confident in our underlying business momentum, but obviously the second half growth rates are very different from the first, with the second half significantly impacted by the very strong launches of Arexvy and in oncology last year as well as the initial stock builds.

In addition, Gardasil was stronger in half two last year, which will impact our profit growth in this upcoming second half.

In summary, we are pleased with our first half performance and confident in achieving our upgraded full year guidance as well as all of our medium and longer-term outlooks.

Next slide, please.

Turning to our IR roadmap, which shows our progress towards major milestones and value unlock opportunities.

As you can see, we have made good progress in the first half, in the second half there are a number of major milestones expected, notably in respiratory.

First, the presentation of the detailed SWIFT-1 and SWIFT-2 data at the ERS Congress for depemokimab in the treatment of severe asthma in patients with an eosinophilic phenotype; second, the Phase 3 data readouts of depemokimab for chronic rhinosinusitis with nasal polyps; and finally, the Phase 3 data for Nucala in COPD.

We also look forward to our next Meet the Management event at the end of the year, which will be the first introduction to our early-stage pipeline.

And with that, I will hand back to Emma to conclude.

Thanks, Julie.

So to summarize, GSK continues to deliver on its commitments and perform to a new standard.

Our excellent performance in Q2 underpins the strong momentum across the business.

We're pleased to be upgrading guidance and expect 2024 to be another meaningful year of growth in sales, profits, and earnings as we continue to focus on prevention and changing the course of disease for millions of people.

We're confident in delivering our growth commitments, and we continue to progress with development of meaningful innovation in our core therapy areas.

Our strong momentum underscores our confidence to sustained profitable growth through this decade, deliver scale, health impact, and attractive returns for shareholders, combining science, technology, and the talent of GSK people to get ahead of disease. together.

With that, I'll now open up the call for the Q&A with the team.

Thanks, Emma.

Peter Verdult, Citi.

Peter Verdult, Citi.

Two questions, please.

Just firstly, for Emma and Luke, I'm sure you're going to get a lot of questions on this, but let's just head it straight off.

In light of the vaccine dynamics that you are calling out today, and yesterday's comments from Pfizer and Merck, can I just push you a little more on firstly, what you're seeing in China, when you think realistically you can return US Shingrix to growth?

I realize that's sort of a difficult question to answer, but I'll try.

And then lastly, how are you feeling about the contracting for 2024 US RSV in both the retail and non-retail channels?

And then a very different and quick question for Tony.

Just can you remind us why GSK still has enthusiasm for the TIGIT mechanism in light of disappointing competitor data sets?

Is there any differentiation that you want to call out on EOS-448?

Thank you.

Thanks very much, Peter.

Well, let's go to Luke on all three of those.

I just would refer you back to his introduction earlier today, the update has shown some short-term impacts on our vaccines portfolio.

But we remain very confident in our medium-term outlook and the strength of our products today and their prospects as well as the pipeline that continues to developing vaccines.

But Luke, both on China, US Shingrix, and I know great confidence in the contracting for the season.

Thanks, Peter.

I suspect you're not Robinson Crusoe with these questions.

So I'll spend a bit of time on it.

I mean, firstly, on contracting, very happy.

Based on what we can see, we will retain market leadership.

We're on track to be a blockbuster.

We can cover ACIP a little bit later on.

But yeah, I think we're very happy with the work that's been done by the team on the ground there.

In terms of vaccines in China, Look, I mean, I think at a macro level, we're extremely happy with the partnership that we've started with Zhifei.

This is a strategic partnership.

This is a long-term partnership.

The start-up process for Shingrix has been completed in Q1.

We have reps on the ground as of the end of May.

And if you just look at numbers, they've already expanded from 6,000 points of vaccination that we were covering.

They've already hit 19,000 and are on track for around 27,000 by the end of the year.

So the scale of that company and the impact that they can bring for Shingrix in China is clear.

Now in terms of broader vaccine demand, we did see some softness in Cervarix, but it's confounded by the fact that we moved resources off the product as well.

We do hear some signs that some of the local CDC do have tighter budgets.

And this is something we're going to watch very, very closely.

But for us, the key here is that Shingrix is at a very different point in the life cycle to HPV vaccines.

We're just getting started here.

So we've got the best possible partner.

We'll build the opportunity.

If you look at the opportunity, it's very similar to the US, when you look at people in China that can pay out of pocket and that are in key cities, so the numbers are very large, but we need to build that.

We've just shipped the 60% of the remaining, we'll ship the rest of the order.

In the second half, we did have a delay of shipment, not demand-based. -- but we just booked another GBP94 million in July.

So we're on track to fill the full contract for the year.

So that's China.

If we get on to the US and Shingrix growth, I mean basically for the full year in Shingrix, we're not going to grow versus last year, but the second half, obviously, is going to be stronger than the first half.

If I just expand on the three factors and the first two, let me be really clear, these are half one dynamics, so we've moved through them.

The first one is wholesaler, as I said in my earlier comments, that delta is about 300,000 doses.

So we finished quarter four '23 with 700,000 in the wholesaler and that's typically what we like.

As I've said on previous calls, in Q2, it went down to around 400,000.

So that's something though that we expect to be rebuilt as we go into the flu season.

The second factor was CMS rule changes covering direct and indirect remuneration or DIR fees.

And just as background, these are basically discounts pharmacies pay Medicare PBMs and plan sponsors if certain quality measures are not met.

And the complication has been historically the PBMs can request these retroactively for up to six months from the point of sale.

So that's obviously a complication for the pharmacy and the pharmacy group.

The new rule that was brought in remove retroactive, the retroactive part.

So basically, at the point of sale, all of these components had to be booked and visible.

And what that meant was for the six months, so from January to June, there was just less incentives for pharmacies to vaccinate patients.

And we saw them shifting volumes between different types of vaccines to offset that.

We've now moved into the second half of the year.

We look at market research, tracking, et cetera.

TRx trends adjusting for July 4 is looking very encouraging.

The key thing also, this is very much a pharmacy structural element that has expired.

If we look at market research for physicians, and their enthusiasm to recommend Shingrix either strongly or extremely strongly.

If you're looking at 65-plus, it's 88%.

So that's the same as last year. 60 to 64 is 80%, so again, same as last year. 50% to 59% is around 50%.

So that's all where it was.

If we look at patient engagement, that's also holding overall, but that leads to the third factor, and this is something I've mentioned on previous calls.

As we penetrate this population and if you look at the rate that we've penetrated with Shingrix, is double the rate of PCV.

So we've got there in seven years, what it took PCV vaccine to get there in 14 years.

But as I said before, the most motivated people obviously sort out the vaccine, and we've been able to penetrate those populations to a very high degree.

In our number one segment, we're around 66% penetration.

So we have to work harder to get less engaged people, less motivated people.

There is a huge plan to do that.

So we will be looking at patients which are resident in other specialties, we're looking at COVID, we're looking at comorbid ways that we can stop leakage, some account management work that we're doing as well.

And then we're just really changing our marketing mix to focus on segments who -- and pop-up to activate.

So that's the plan.

And if you put all this together, basically, we'll expect some growth in half two.

But again, we're at this evolution of really looking outside the US to Europe, Japan, Australia, and China for our growth.

And then ultimately, once we've moved through those cohorts, we'll get to emerging markets as we've covered on previous calls.

Long story short, we can navigate this and we remain confident that we could hit our GBP4 billion target with Shingrix in 2026.

So a long answer, but hopefully, that is helpful to everyone.

Great.

Thanks very much, Luke.

I really want to reiterate that confidence in the broader vaccines portfolio and the maintenance of our 26 CAGRs and excitement to the pipeline ahead. but we do see the growth coming ex-US on Shingrix, but the decline in the US to moderate.

And I would just point out Luke's presentation, that in the US, we absorbed about 36% decline on Shingrix and delivered whilst digesting that 17% growth in our largest country in the world.

So Tony and TIGIT.

Yeah.

Thanks for the question, Peter.

Your quick question might get a slightly longer answer if you forgive me.

And just to remind you, we've said our focus in oncology is very much on hematological and gynecological answers, and we said we'll invest outside of that in a gated way. when we see data that suggests transformational opportunities.

So with that in mind and TIGIT, what have we seen, what are we doing about it?

And why do we think it's happening.

So what have we seen in our GALAXIES-201 platform study, and this is with 120 patients, so a larger patient population than the initial data from the cityscape valuation of similar mechanisms.

What we see is similar overall response rates, but a speed and quality of response that is differentiated from those observed previously.

You'll hear more about that when we present on these preliminary data at the end of the year.

So I'll pause on that at this point.

What we're doing with that data now is moving into the GALAXIES-301 Phase 3 study.

And an important thing to bear in mind about the characteristics of that study, first of all, it's in combination with Jemperli, we're learning there from what we've seen in the PERLA lung study.

It's also in a carefully biomarker-selected population, and it is with EOS-448 or belrestotug for those of you who haven't connected the two together.

What we expect to see as a consequence of the differential profile for EOS-448, it's an IgG1 antibody, which means it has a functional Fc region, the constant region of the antibody.

That means it engages macrophages, dendritic cells and natural killer cells in the tumor micro environment, augmenting immunity.

And also, it induces something called ADCC, which is antibody-directed cellular cytotoxicity and that results in the killing of T regulatory cells, which are immunosuppressive in the tumor environment.

We've seen that latter feature of depletion, both preclinically and clinically.

So in short, differentiated data moving forward in a gated Phase 3 study and designed based on what we've learned from PERLA, with a molecule that we think has differential characteristics.

So more to see at the end of the year and a strong focus on making those decisions.

Thanks Tony.

Next question, please.

Peter Welford, Jefferies.

Hi, thanks for taking the question.

Sorry, but I want to come back to the vaccines.

Can we just come back to Arexvy for a minute and just understand, Luke, particularly on the contracting.

I understand that you're very confident with the market, (inaudible), the share of the retail, but there are two things, I guess.

Firstly, can you just talk about the appetite and what you've had here on contracting discussions insofar as?

I mean, maybe you can talk about the extensive vaccination we've seen in that 75-plus cohort about the motivation you see in that group for greater incentive year on year, perhaps for those to come in versus, on the other hand, the lower obviously age where there's less of a strong recommendation.

And equally, if you could just talk a little bit about then the non-retail segment, what you're seeing there.

Do you see any change to that segment going into the second half of this year?

Or do you still anticipate that to be a relatively minor part for RSV given the recommendation that we've seen for 75-plus year olds?

Thanks, Peter.

So Luke, proceed.

So Peter, maybe what I'll do is I'll talk through.

I mean the key thing is we are confident with the Arexvy in terms of the long-term ambition of GBP3 billion.

And you're right.

I mean the June 8 set was positive for 75-plus.

And if you look at our immunization rate in 2023, of that population, which -- our numbers, that's about 26 million.

Under shared clinical decision-making, we achieved an immunization rate of around 18% overall, all products.

If you look at the 60 to 74 with ACIP, there's no way you can escape that as a negative for the class, right?

We have to be realistic there.

But there is some lining to the cloud, some silver lining to the cloud when we break that population down.

So if you look at 60 to 74 under shared clinical decision-making in '23, the immunization rate was around 13%.

Now the hard part right now, of course, is we don't know where CDC is going to set the boundaries in terms of what high-risk or complications, is it diabetes or is it advanced diabetes?

So it's a bit difficult.

But if we just -- along the lines that you were talking about if we just look at people with other complications in that 60 to 74 group, it's a similar number, it's about 26 million.

And if you look at the immunization rate, that was under share clinical decision-making for the 60 to 74 population last year, it was about 16%.

If you look then a little bit more tightly at the 65 to 74 at increased risk, it was actually high, it was 19.5%.

So I assume that's because we're a bit more mobile, easy to reach in the pharmacy versus care homes, et cetera.

So there's clearly in that population areas engagement, and it will just depend on how CDC sets the rules.

In contrast, if you look at healthy people, the penetration rates were much lower.

So it was around 11% in the 60 to 74 population and around 15% in the 65 to 74 if you slice it more narrowly.

So yeah, I think there's going to be more momentum for 75, but you've taken a big chunk of people out in the 60 to 74.

And what we don't know is the reaction of physicians with ACIP's changes, whether they're going to withhold recommendation in some populations.

So it's difficult to project.

Obviously, Q3 is going to be a key.

And our intention is to maximize Arexvy there.

We've been very, very deliberate with this product.

It has been positioned from day one for high-risk individuals.

And then when you look at PCP, preference and patient preference, that's clearly the leader in the minds of physicians and patients that are aware of it.

And that makes sense, right?

Our data is the strongest.

As I said before, it's the one you'd give your mum, and our plan is to go back -- feel free to add, Tony -- is to go back to ACIP with 50 to 59 data with the updated benefit risk safety data and GBS and also when we've got the full package, the three-year data.

Let me just pick up on one point of that because I suspect we're going to deal with more questions around ACIP, but just to underscore Luke's point in the populations, the detail.

We have a very strong data set, for example, in the 70 to 79-year-old, so that was a 94% vaccine efficacy in the first season and 75% across two seasons.

See that also with A versus B coverage, so we're confident in the strength of our data and our continuing ability to add to that data set as we accrue more -- and of course sales, because I'm sure we'll get more questions around it.

Luke, is there anything you want to add on the retail channel?

Yeah.

I mean historically, it's around 85%.

We don't see that as changing.

When you look at market research, why -- and we've obviously looked at this a lot.

When we show this change in Shingrix with the IRA removal of the co-pay and when you look at patients' reasons for going to the pharmacy, from memory, it's like 58% of them site that the process is easier, the physician prefers to do that.

There's greater certainty around coverage and out-of-pocket costs.

So we think that structurally will remain the same.

As Tony said, we'll be back in with the 50 to 59.

But I think ACIP is going to be very conservative about broader coverage until they've got complete clarity in terms of benefit risk.

And I think that's important in the non-retail segment.

Yeah.

And it's probably just worthwhile underscoring the 50 to 59 that we see no change in benefit risk proposition for the vaccine relative to season one in that population or indeed in the broader group.

James Gordon, JPMorgan.

Hello.

James Gordon, JPMorgan.

I'll stick with the vaccines team.

My first question was just the vaccines guide for '24.

So you load it quite significantly today, I think it's about GBP700 million is the difference.

So the question we have, how much of the downgrade is Arexvy being lower versus Shingrix?

Am I working out right that it looks like the guidance roughly has Arexvy being about flat at only in the second year in the market or even not growing maybe even be slightly down or if I miscalculated that?

And the other question was just Arexvy and revaccination.

So we saw the two-year revaccination for antibody titer data at ACIP.

And the ACIP panelist was a bit cautious on the data, and I think I had a comment now that you're going to share some more data in the coming months.

So is that the [knock-knock for] clinical trial and showing the waning of protection.

So are we going to in the next couple of months have all the data that relates to whether you can get this two-year revaccination interval?

And what is your confidence in getting that, now we've seen some more data?

Great.

Thanks, James.

Well, I'll come to Julie first to give you the building blocks of the guidance of the year, remembering we are annualizing against the launch.

And then Tony will come to you on data and revax.

Thanks, Emma.

Yeah, so in terms of the overall position with the second half, you can probably recall the very strong vaccine performance that we had in half two.

And the change in the guidance overall to the low to mid-single digits is primarily relating to RSV for the reasons Luke mentioned relating to the age groups in the ACIP decision making.

As Emma mentioned also, the stocking impact last year was fairly significant.

So you'll probably recall that in Q3, we mentioned we got [$0.02] of the sales, we're actually stocking going into the channel, together with about 20% towards the end of last year.

So there is a very significant first half, second half impact with vaccines.

You'll probably recall our growth rates in vaccines last year were 33% and 34% in Q3 and Q4.

So this is the headwind that we face now going into this period.

And I think Luke summarized it very well just in terms of the exact guidelines in terms of what they actually mean in terms of people at risk of RSV, whether it's a normal diabetic, whether it's one with complications will make a big difference in the second half performance.

Great.

Thanks, Julie.

And just to reiterate that RSV update is purely related to ACIP, nothing competitive.

And as Luke said earlier, we'll be looking forward to being back to great growth in '25 and confident in the long-term prospects of this vaccine.

Tony, do you want to talk about the data to come, revax?

Yeah, sure.

And James, just quickly, 004 is the immuno study, but I want to describe this in the context of the entire data set since that's really the important aspect with regards to revaccination.

We've said we have 006, which is the vaccine efficacy study, 004, the immunogenicity study, and the study is looking at immunogenicity, which we started, for example, in the immunocompromised population.

A decision on revaccination will depend on the trends in vaccine efficacy and the ability to boost that in itself depends on how the various aspects of the immunological profile wane over time.

I think we talked about this at the last call with regard to our expectations on duration.

And at this stage, I'd say rather than making guesses, given that we're only a few months away from the whole data package that we will be presenting at ACIP, so we wait for that.

One thing to stress, though, within that, for me, is what we're learning from ACIP is a greater focus on benefit risk, and therefore, the importance, for example, offered by a longer duration vaccine, both with regards to greater value and benefit risk.

Richard Parkes, BNP Paribas.

Thanks, Nick.

So I've got one on vaccines, one on gen med.

On gen med, obviously, performance has been strong.

I know that's partly driven by a strong Trelegy demand, but also better navigation of the AMP Cap removal.

So can you just talk about how much of that performance is sustainable into 2025 versus turning to a headwind?

And I'm thinking about things like stocking for authorized generics, et cetera.

So just thinking about gen med performance into 2025.

Then secondly, just to push on Arexvy a little bit more.

Could you help us just understand how much true visibility you've got on likely second half demand based on the contracting?

And I'm just trying to compare it to maybe the flu vaccine market, which generally feels like people have got good visibility there.

Obviously, with the ACIP panel recommendation happening only recently, it might take some time for retailers to digest and predict the demand.

And obviously, that could work both ways, either additional orders for you and upside or downside through returns.

So could you just talk about your visibility and where the risks lie either to the upside or downside for Arexvy guidance?

Thanks.

All right.

Well, two more questions for Luke although we will guide on '25 in '25.

And there's no change to our midterm CAGRs for gen med's obviously great performance there.

So do you want to start with that, Luke?

Yeah.

And thanks, Richard.

Look, I think a lot of it is really one-off effect of authorized generics and I'm pleased to say that we were more successful than we're expecting in terms of being able to capture those patients as they came on Advair and Flovent.

With Lamictal, we just took a price hit and that was very sizable.

We did that because we didn't want to disrupt those patients.

So the underlying growth is lower, and it's very much along the language we used in the past with general medicines over the longer term.

I mean Trelegy itself continues to grow very strongly.

But of course, it did that outside the US as well.

I mean, Japan was up 29%, China, 26%, and the EU was up 15%.

So this is an excellent medicine.

It's one that we're going to continue to back.

We had 10 recent presentations, publications.

So there's a lot of momentum there.

But yeah, again, we'll start to lap those components of shifting and the movement with authorized generics in the second half of this year and '25, I won't comment on.

In terms of clarity, I mean, the key difference structurally is with flu, we do a lot of pre-booking because there's a manufacturing cycle, it's a new product every year.

It's definitely softer this year.

If we look at flu volumes, they were higher than normal in the first half in the US, but Southern Hemisphere was weak.

So it's not a really good surrogate with Arexvy, where we don't have guaranteed volumes.

We've got guaranteed percentage splits, which I won't go into, and that's why I'm quite happy about where we landed.

And I think the other factor is pricing.

You've got these contracts with good prices, and that was very, very important to us when we take a long-term view on what is an excellent asset.

Graham Parry, Bank of America.

Hey, thanks for taking my questions.

I'm sorry, but it's more on vaccines.

With actually, you said about having US market leadership in the second half on volumes, and you said you sort of have a good idea of split.

So can you help us understand, I think up to this point, you've been two-thirds of the volume for this season, Pfizer started contracting a bit earlier, you've had -- didn't obviously enter the market

So is two-thirds what you'd be aiming for?

Or should we be just thinking about having the majority of the market even?

Or is it less than that?

And then secondly, on your peak sales of GBP3 billion and return to growth in 2025, does that assume that you are going to have some sort of booster regimen in there or can you get there by just rolling out globally?

And if you could help us understand on the boosters with the season three vaccine efficacy data for a single dose that you're expecting in the second half?

I think your modeling data on the all-comers population has suggested that the single administration could drop to around 40% in season three, which would certainly warrant a booster, but in the populations you're now recommended for the over 75s in the comorbid.

It looks like those are much higher in the 70s across season 1 and 2.

So do you have any sort of predictive modeling data of where vaccine efficacy on those target populations might drop to that would perhaps allow for a booster to be recommended?

Thanks.

So Luke, and then we'll come to Tony on booster.

Sure.

Graham, I won't give you a percentage, but it's market leadership.

I think what is not visible to us yet is how much Moderna picked up relative to Pfizer.

But we know how much we've picked up, and that's why we're using the term leadership.

I think the other thing, of course, one thing is volume, but it has to be multiplied by price.

And that's something else that will be more visible in time to the aggregate revenue.

In our forecast, we assume that a booster is required.

Tony, I'll hand over to you for the rest of that.

Yeah.

And look, Graham, I'd say at this stage, what I've done, it is really, this is a matter of waiting and seeing.

Otherwise, I'm drawing straight lines between two points to get an estimate of where season three is bearing in mind that the dynamics in season one and season two were very different.

And as I mentioned earlier in answering Graham's question, I think it's not just a combination of vaccine efficacy, but also the booster response.

So we'll know more about that when we get ready for ACIP in October.

Tim Anderson, Wolfe Research.

Thank you.

A non-vaccine question. which is an Zantac.

And obviously, for investors downstream of the Delaware ruling, I know Glaxo will say it will continue to depend itself, lots of studies in your paper, but in the theoretical event Glaxo were enter into a broad settlement to try to put all of this behind the company, what's realistically the earliest this could happen?

Is it safe to assume that would not be possible until 2025, possibly well into 2025?

Thank you.

Yeah, thanks, Tim.

And so actually we do absolutely recognize the impact this litigation has had on shareholders.

And you're right, I am going to start by reiterating the fact and the science here, which is total scientific consensus that there is absolutely no consistent or reliable evidence the initiating increases the risk of any cancer.

And so we're going to continue to vigorously defend ourselves against all of the claims and manage the litigation in the best interests of the company and of shareholders.

That's been our focus all the way along.

And we are confident that we have done so in the process.

And that means no change to our growth agenda, no change to our guidance, no change to our investment plans.

Our position is based on science and facts.

And our focus is to address this in the interest of shareholders and the company.

And as I'm sure you know, there is obviously a limit towards I can say around this litigation since we need to respect the judicial process and protect the interests of the company.

Mark Purcell, Morgan Stanley.

Yeah, thank you very much.

Just a few questions.

Firstly, on China and vaccines, are you seeing much in the way of emerging domestic competition I think BCHT has a shingles vaccine, for example.

And in that respect, what's the appetite from Zhifei to extend the agreement to Arexvy.

One on Arexvy boosters, it's been suggested that revaccination only achieves 45% to 65% of peak neutralization titers due to immune interference from the T4 fold on trimerization [T-RAG], which is used by Arexvy and Abrysvo as well.

So I just wondered if it's the factor and if we've seen this sort of before.

And the last one, in terms of Nucala, ahead of the COPD MATINEE data late Q3, Q4 I think, Tony, you've described the efficacy is likely to be in the low-20s in terms of reducing exacerbations.

Sanofi CSP is a [5 billion] peak potential across its two assets.

So I just wondered if you could help us understand how large the opportunity you see is for your IL-5 focused medicines?

Thank you.

Well, we'll come to look quickly on China.

I mean, we point that's quite hard really on top to come up against Shingrix with an effective vaccine, and we've got 18% efficacy for 11 years.

And then we'll come to Tony on both the booster question and Nucala and the broader opportunities in COPD in the pipeline, please, Tony.

So Luke first.

Yeah.

Thanks, Mark.

I mean there is a local competitor to Shingrix.

It's a company called

[Ganway].

It's a live attenuated vaccine.

So it's also Zoster Vac flag, its license is 40-plus.

But they get around a quarter of the volume at this point.

But again, these are very different patients, the ones that we're targeting.

We're targeting high out-of-pocket tolerance, willingness to pay population, which is different.

In terms of Japan and relationship there, as I said earlier, it's excellent.

It's a strategic long-term relationship.

And we have had some initial discussions around RSV, and we would very much like to expand the collaboration to include RSV.

So just watch this space.

Yeah.

Thanks, Mark.

Just quickly then on the T4 construct.

This is obviously something we spotted and were eager to understand as well.

The short answer to that, well, we haven't disclosed the data there's no evidence of interference.

What is a much more likely and common explanation for the boost is the relative waning in the vaccine efficacy in the first instance and it's generally understood that the greater the waning of efficacy, the greater the boost.

So you'll see more on the folding question when we disclose those data.

In terms of COPD and IL-5, let's just start by putting your comment with regards to dupilumab versus depe into context -- sorry Nucala into context, I've mentioned this in the past, and I appreciate there's a lot of sort of comparative numbers floating around.

What's important is, I said, based on the patient population that we've targeted in our Phase 3 study in MATINEE, which is a broader population and includes emphysemic patients.

These represent about 30% of the COPD population, so a significant proportion of the approximately 300 million individuals with COPD.

That population is more difficult to treat even in the high eosinophilic setting.

And because of the different patient mix and based on what we've seen in the past, that's where my prediction for sort of mid-20%s -- low to mid-20%s percent for MATINEE comes from.

It is not a reflection of relative efficacies of the two molecules.

What both factors are showing is that there is a significant response for those with COPD and high yield counts in this instance, in particular, over 300 caps.

We're very well-placed in the COPD arena and evaluation of not just IL-5, but of the mechanisms.

I would point to, first of all, of course, we're looking forward to the progressing on depe with once every six-month dosing.

That is a significant advantage in COPD, even greater than it is in severe asthma.

And in addition to that, TSLP offers a broader opportunity in the risk data from Amgen in COPD with that TSLP and albeit with a much lower -- with a much more frequent dosing regimen, of course, that teze suggests that we should also have opportunity there.

I'll pause, but there are additional aspects of our COPD portfolio that I look forward to telling you about in the future.

Emily Field, Barclays.

Hi, thanks.

I'll just ask two quick ones.

One on ex-US.

Arexvy, one of the things that Pfizer talked about yesterday in terms of their ex-US contract wins was a desire to simplify the contracting between having one option for maternal and on older adults.

I know this year is mostly going to be US-driven for Arexvy.

But is that something that you see as an obstacle to ex-US Arexvy.

And then just on the HIV guidance, third year in a row of expecting double-digit growth in HIV.

You have your CAGR target of 6% to 8% still intact.

Are there any reasons to expect a slowdown in the next couple of years in HIV or why not upgrade that guidance?

Thank you.

Thank you.

Well, let's get to Deborah first on HIV, and then we'll come back to get any further comments on Arexvy from Luke.

Yeah.

Thanks for the question, Emily.

So I think in quarter one and actually reiterated on Friday when we did our update post the age conference.

We are tracking towards the top of our guidance.

As you say, we've had three years of double-digit growth.

Next year, we have the headwind of the IRA.

We've stated very clearly that that's going to be around a GBP200 million impact.

And then obviously, we've set out very clearly in 2026, what we think the shape and the size of our portfolio is going to be.

So we should be reaching GBP7 billion if not slightly above, which is what we've kind of shared with you all in 2026.

And then by 2027, obviously, we are moving into a world where we've got 40% of our portfolio in our -- portfolio value in long acting.

So I think at the moment, everything that we've said '21 to '26 holds firm, we are at the top end of that CAGR.

And then as we move into 2027, we remain extremely confident that the long-acting medicines in our portfolio will be 40% of our total revenue, if not more, because obviously, we're having a very successful period with those medicines at the moment.

So no change in our guidance, but just I think your feeling or increased confidence because of the feedback we get from physicians and patients as to the impact that our long-acting medicines are having and the growing momentum for those medicines.

That's great to see the progress in the pipeline you've been announcing just through into last week too.

So Luke?

Yeah, thanks, Emily.

The short answer is no.

I mean, typically, the way the contracts and NIPs are constructed are they separate out pediatric populations from adult populations and really what counts.

And it's different to ACIP, of course, is the systems are willing to concentrate on single vaccines and separate them out more vigorously versus push them together.

And so our approach is to really, we have an excellent asset here in Arexvy.

What we want to see is the full profile, as Tony mentioned, we want to see what this product looks like at three years because that is going to have a huge impact on pricing, durability, et cetera, which are all the things and particularly in European contracts that players concentrate on.

So we're happy to let people bid against themselves.

We want to sit and wait and see what the true picture of the product is and then build a business based on that.

And as I said before, the numbers are looking very good for Arexvy.

Once we have that, we will then move ahead and execute.

So given that we're coming up to about a quarter past the hour, I'm going to take one more question, so apologies to the four of you that didn't get to ask a question, but we're going to go to Simon Baker at Redburn Atlantic.

Thanks very much.

And I should respectfully limit up to one question.

It's on Arexvy, but it's one for Tony.

In terms of the potential mechanism for lower incidence of dementia.

I just wondered what thoughts you had on that.

There's been some suggestion that it's an indirect effect caused by the vaccine suppressing reactivation of HSV-1 virus.

But any thoughts you got on why we're seeing this effect.

It would be much appreciated.

Thank you.

Yeah, Simon, I presume you mentioned Arexvy in there.

[that's actually another story].

Look, it's fair to say there's very little known here mechanistically.

We're investing in further retrospective studies and mechanistic ones.

Let me just try and do this quickly.

There is some potential that the mechanism may be vascular in nature.

It may even be due to, as you say, underlying, let's call it, subclinical reactivation.

It's the science is [better known], although not by any means comprehensive for HSV underlying reactivation and therefore, inflammation that occurs as a result of that leading to dementia.

One can imagine a similar story in the context of shingles or one could even imagine that constant reactivation impacts in microglial function.

So there are a range -- and I haven't been comprehensive in that answer to avoid on spending too much time on it.

It's fair to say there's a range of different mechanisms.

If you want a comprehensive summary actually, the Australian paper detailing the epidemiological retrospective outcomes has a really nice summary and it's completely in paragraph.

Thank you.

I mean it's exciting science to explore still in early stages.

In the meantime, this is a very effective vaccine with still a lot of opportunities to penetrate around the world.

So with that, Nick, is our last question, a big thank you to everyone.

We are really pleased with our Q2 performance and another upgrade to our outlooks and even more looking forward to the ongoing progress in our pipeline and delivering on our short, medium, and long-term ambitions.

Well, thanks to everybody for joining us for the call.

We look forward to following up with you in coming days.