Q2 2025 GSK PLC Earnings Call

Ladies and gentlemen, a very warm welcome to the GSK Q2 2025 results call.

I'm delighted to be joined today by Emma Walmsley, Tony Wood, Luke Miels, Deborah Waterhouse, and Julie Brown, with David Redfern joining for Q&A.

Today's call will last approximately 1 hour, with a presentation taking around 30 minutes and the remaining time for your questions. Please ask only 1 or 2 questions so that everyone has a chance to participate.

Before we start, please turn to slide 3.

This is the usual Safe Harbor statement. We will comment on our performance using constant exchange rates (CR) unless otherwise stated. I will now hand over to Emma on slide 4.

Thank you, and welcome to everybody joining us today. Please turn to the next slide.

Our second quarter results, once again, demonstrate GSK's strong performance, momentum, and the quality and strength of our portfolio. Group sales are up 6% for the quarter, core operating profit was up 12%, and core earnings per share grew 15% to 46.5 p.

Sales growth was driven by our largest business, Specialty Medicines, up 15%, and vaccine sales, which also contributed with sales up 9% in the quarter. This led to increases in profits and earnings, which also benefited from a strong focus on SG&A.

Alongside our operating performance, we continue to make good progress in R&D, with 3 FD approvals achieved so far this year.

Cash generation also remains very positive, with £3.7 billion generated in the first half to support further investments in growth and returns to shareholders.

The dividend for the quarter was 16 pence. We have now completed more than £800 million of the share buyback program initiated in February.

All of this is underscored by our commitment to operating as a responsible business. Our most recent action has been to expand our voluntary license agreement with the Medicines Patent Pool to now include long-acting capital for the treatment of HIV, as well as prevention.

And finally, driven by our strong performance, we're confirming today that we now expect to be towards the top end of the financial guidance given for 2025. Next slide, please.

Following the demerger of Halen, we made a commitment to drive a step change in performance at GSK.

This quarter has again shown that GSK is delivering consistent sales growth, operating leverage, and positive financial performance.

The investments and development choices we made in our portfolio, notably to launch new specialty medicines, have really helped to drive these new performance levels.

In the last 3 years, we've launched innovations in respiratory, immunology, oncology, and HIV, and we have a lot more to come.

A new vaccine to prevent meningitis and an antibiotic to treat urinary tract infections, three of the five product approvals we expect this year, are specialty medicines. Tony will talk about each of them in more detail shortly, but let me touch just briefly on Blenrep.

As you'll have seen, the FDA has extended the review period for Blenrep with a new target action date of October 23rd. We remain very confident that Blenrep can bring significant benefits to patients with multiple myeloma in the U.S. and are in constructive discussions with the agency.

Meanwhile, we continue to receive approvals and prepare for launches of Blain in many other countries, including across Europe, Japan, Canada, the UK, and Switzerland.

So, with the portfolio we have and the launches to come, we expect specialty to be a major driver of growth for GSK. Our specialty business accounts for around 40% of sales today, and we expect this to be well over 50% by 2031. Next slide, please.

As we've consistently said and demonstrated, our number one priority for capital allocation is to invest for growth.

We're doing this by focusing strongly on the delivery of the 142. We've previously highlighted all of them with peak year sales above £2 billion by ensuring we have appropriate resources for priority launches and by prioritizing capital in R&D to R&D in oncology, both organically and with targeted business development. Our BD has real momentum and is a key driver of pipeline expansion.

Women and our ADC targeting B7-H3. We will also begin a pivotal trial to support our four-monthly long-acting injectable regimen for HIV treatment.

And we continue to add high-value innovation at earlier stages of development too. The pioneering strategic collaboration announced with Hungary this week is another excellent example of this.

Next slide, please.

With the breadth of our current business and the growth opportunities we have in our pipeline, we are highly confident in our outlook for sales of more than £40 billion by 2031.

And as we've repeatedly demonstrated with our pipeline development, this long-term outlook has consistently improved, and we are ambitious and committed to do more.

Next slide, please.

So overall, with the momentum we have and the progress we're making, we're very confident we can deliver the targets we've set for growth in the short, medium, and longer term. Let me now hand over to Tony to talk to you in more depth about our great R&D progress. Next slide, please.

Thank you. Emma, next slide, please.

Our number one priority in R&D is to develop transformational specialty medicines and vaccines in areas of high unmet need that positively impact health and deliver significant growth. This is evident in the 142 we have for launch before 2031 and in the progress we're making to expand and accelerate our early-stage pipeline of first and best assets. We remain focused on four core therapy areas, enabled by advanced technologies, talent, and a network of world-class partnerships, and we continue to deepen our expertise in the science of the immune system.

This is most recently exemplified with our work to develop IL-5 medicine for lung diseases, which is providing us with a better understanding of the role of the immune system in fibroid inflammation.

Leading us to target diseases beyond the loan, towards kidney, liver, and with the potential future application in neuroimmunology next. Slide, please.

Based on decades of research, we have a unique understanding of the role that information plays in chronic airway disease. Our focus on the underlying biology of inflammation, notably in COPD, has led to a differentiated pipeline of long-acting options, each strongly supported by human genetics, disease phenotyping, and insights from our own scaled clinical trials.

In May, we received FDA approval for new Carla for the treatment of COPD. This is the fifth indication for new Carla in the US. We've also filed a mockup for our novel, ultra-long-acting Isle 5 ontaga treatment of asthma and chronic rhinosinusitis with nasal polyps with regulators, and we have a pedophile date of December 16th.

I'm also pleased to report, for the first time today, positive results from the Agile continuation study, which further underscore the sustained efficacy and safety over a 2-year period of twice-yearly MoAb.

Hi, CHARLES. This is an open-label, 12-month extension study in severe asthma patients who completed either SWIFT 1 or SWIFT 2. The results show that patients who continue to receive dupilumab maintained the efficacy achieved in the prior trials. Importantly,

Patients who crossed over from placebo also saw a reduction in exacerbation rates consistent with results in Lift.

As a reminder, the SWIFT studies demonstrated a 72% reduction in exacerbations requiring hospitalization for patients who received deputy.

I'm also pleased to confirm today that we started an extensive development program for Deppy as an add-on treatment in COPD, the Enduro trials. Our recruiting for the Vigilant trial, designed to evaluate efficacy in earlier-stage diseases, is planned to start later this year.

As the only company with a range of ultra long-acting mechanisms specifically, IL-5, isle 33, and T-slip, we are competitively placed to lead in this disease.

And through our license agreement with Henri, we're now adding a novel potential best-in-class PG3 for an inhibitor addressing gaps in the treatment of patients who face continued dysregulation or who are unlikely to receive inhaled corticosteroids or biologics because of their disease profile.

Last but not least, the camera picks and Cam 1 and Cam 2 trials remain on track and will be reported together in 2026.

Next slide, please.

Tony Wood: Ladies and gentlemen, a very warm welcome to the GSK Q2 2025 results call. I'm delighted to be joined today by Emma Walmsley, Tony Wood, Luke Miels, Deborah Waterhouse, and Julie Brown, with David Redfern joining for Q&A. Today's call will last approximately one hour, with the presentation taking around 30 minutes and the remaining time for your questions. Please ask only one to two questions so that everyone has a chance to participate. Before we start, please turn to slide three. This is the usual safe harbor statement. We will comment on our performance using constant exchange rates, or CR, unless otherwise stated. I will now hand over to Emma on slide four.

As a result, we now have a growing hepatology pipeline with assets to treat chronic hepatitis B, as well as static liver disease (SLD), starting with metabolic dysfunction-associated steatotic liver disease (MASLD) and alcohol-associated liver disease (ALD).

Let's start with hepatitis B. A considerable market opportunity exists with larger men, a need, and limited standard of care.

With the perversion, an oligonucleotide, we have an exciting opportunity for a functional cure.

Emma Walmsley: Thank you and welcome to everybody joining us today. Please turn to the next slide. Our second quarter results once again demonstrate GSK's strong performance momentum and the quality and strength of our portfolio. Group sales were up 6% for the quarter, core operating profit was up 12%, and core earnings per share grew 15% to 46.5 pence. Sales growth was driven by our largest business, specialty medicines, up 15%, and vaccine sales also contributed with sales up 9% in the quarter. This led to increases in profits and earnings, which also benefited from a strong focus on SG&A. Alongside operating performance, we continue to make good progress in R&D, with three FDA approvals achieved so far this year. Cash generation also remains very positive, with £3.7 billion generated in the first half to support further investments in growth and returns to shareholders.

Promising data from The Phase 2, be clear and be sure studies demonstrates a stained loss of HEB surface antigen below. The level of quantification importantly, new insights from recent epidemiological Studies have shown that loss of surface antigen reduces all cause mortality by up to 62% and the risk of developing liver cancer by up to 89%. In HPV patients, we expect to present additional follow-up data from Bure at aasld later. This year, our phase 3B World trial continues. A pace with data expected in the first half of 2026,

I'm also delighted to share that the United Phase 2 study has completed recruitment four months ahead of schedule. This trial is looking at sequential administration of data, serine, and tomLec, followed by bepi, which will read out in 2025 if positive. It will significantly expand the patient population who could benefit from treatment.

As already highlighted, we're also excited to complete the acquisition of a famous Furman or Fe. This adds another phase 3 ready potential best-in-class medicine to our pipeline.

Emma Walmsley: The dividend for the quarter was 16 pence, and we've now completed more than £800 million of the share buyback program initiated in February. All of this is underscored by our commitment to operating as a responsible business, our most recent action being to expand our voluntary license agreement with the medicine's patent pool to now include long-acting cabotegravir for treatment of HIV, as well as prevention. And finally, driven by our strong performance, we're confirming today that we now expect to be towards the top end of the financial guidance given for 2025. Next slide, please. Following the demerger of Halion, we made a commitment to drive a step change in performance at GSK. This quarter has again shown that GSK is delivering consistent sales growth, operating leverage, and positive financial performance.

Fe is a once-monthly SGF-21 analysis with the potential to reverse liver fibrosis in MASH. We plan to start Phase 3 trials in the National later this year, with plans for further development in ALD.

And of course, the development of GSK 9990 is S NA. Therapeutic continues for other subsets of patients with SLD.

We see these two assets as complementary, providing options to develop both monotherapy and combinations.

Let's turn to oncology now. Next slide, please.

Here, our momentum continues, and we're rapidly expanding beyond our current focus on hematological and gynecological cancers to treat additional solid tumors.

On Blaine, right? As Emma has said, the new pedophile date is the 23rd of October 2025, providing the FDA with time to review additional information provided in support of the application.

Emma Walmsley: The investments and development choices we made in our portfolio, notably to launch new specialty medicines, have really helped to drive these new performance levels. In the last three years, we've launched innovations in respiratory, immunology, oncology, and HIV, and we have a lot more to come. Alongside our new vaccine to prevent meningitis and an antibiotic to treat urinary tract infections, three of the five product approvals we expect this year are specialty medicines. Tony will talk to each of them in more detail shortly, but let me touch just briefly on Blenrep. As you'll have seen, the FDA has extended the review period for Blenrep with a new target action date of the 23rd of October. We remain very confident that Blenrep can bring significant benefit to patients with multiple myeloma in the US and are in constructive discussions with the agency.

We're in constructive discussions with the FDA. While I know you'll want more details, the review process remains confidential. I'll update you when we can.

Outside the U.S., we've already received regulatory approvals from Europe, Japan, Canada, the U.K., and Switzerland, all pointing to the positive impact this medicine can have for patients with multiple myeloma.

Elsewhere in the portfolio, we are progressing multiple development programs. Last year, Jan Perry was expanded to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit in these indications. Initial results from the AZIO-1 trial in rectal cancer are expected in 2026, with the Phase 3 Jade study in locally advanced head and neck cancer also ongoing.

Emma Walmsley: Meanwhile, we continue to receive approvals and prepare for launches of Blenrep in many other countries, including across Europe, Japan, Canada, the UK, and Switzerland. So, with the portfolio we have and the launches to come, we expect specialty to be a major driver of growth for GSK. Our specialty business accounts for around 40% of sales today, and we expect this to be well over 50% by 2031. Next slide, please. As we've consistently said and demonstrated, our number one priority for capital allocation is to invest for growth. We're doing this by focusing strongly on the delivery of the 14 scale opportunities we've previously highlighted, all of them with peak year sales above £2 billion, by ensuring we have appropriate resources for priority launches, and by prioritizing capital in R&D to RINI and oncology, both organically and with targeted business development.

For a jar of studies, efforts are underway to expand the label into MDS, and additional indications are also in planning.

We have a high ambition for our new ADC portfolio, and given the significant potential we see here, we're prioritizing investment.

To is PGL, 1 indicates the potential for a chemo-free regimen in the first line. Small cell lung cancer with more mature data is expected in November.

And we're on track to start a pivotal study before the end of the year.

For GSK 584, RB7 H4, ADC will start pistol studies early next year.

Emma Walmsley: Our BD has real momentum and is a key driver of pipeline expansion. We'll be adding four high-potential assets to late-stage development this year, and three, starting phase three, were sourced through discipline BD, IDRX, MRSV, and our ADC targeting B7H3. And we'll also begin a pivotal trial to support our four-monthly long-acting injectable regimen for HIV treatment. And we continue to add high-value innovation at earlier stages of development too. The pioneering strategic collaboration announced with Hungary this week is another excellent example of this. Lastly, and very importantly, we continue to optimize our supply chain with significant investment in US manufacturing and scaling up of capacity for our new modalities and technology platforms. And as we said last quarter, our overall planned investment in the USA is in the tens of billions of dollars over the next five years. Next slide, please.

Lastly, earlier this year, we entered into an agreement to acquire RX42, a highly selective kit inhibitor being developed as a first and second line therapy for the treatment of gastrointestinal stromal tumors, or GIST.

RX 42. Now, GSK 981 has demonstrated activity against all key primary and secondary mutations observed in Geist.

This breadth of coverage, in addition to high selectivity, which could provide improved tolerability, offers a potential best-in-class profile.

We'll start recruitment for a pivotal study in second line before year-end.

Next slide, please.

Within infectious diseases, we're developing prevention treatment options with broad coverage.

Two of our recent FDA approvals exemplify this.

And then our pentavalent, the Ninja Cockle vaccine offers more strain coverage, enabling higher protection from the serious consequences of infection to more teens and young adults.

Emma Walmsley: With the breadth of our current business and the growth opportunities we have in our pipeline, we are highly confident in our outlook for sales of more than £40 billion by 2031. And as we've repeatedly demonstrated with our pipeline development, this long-term outlook has consistently improved, and we are ambitious and committed to do more. Next slide, please. So, overall, with the momentum we have and the progress we're making, we're very confident we can deliver the targets we've set for growth in the short, medium, and longer term. Let me now hand over to Tony to talk to you in more depth about our great R&D progress. Next slide, please.

And Betta is the first new class of antibiotic in over 30 years for the treatment of uncomplicated UTI, a condition that affects 50% of all women.

We're also making progress with other ID assets. Our Phase 3 trials for Tabby Penan and the treatment of complicated UTIs were stopped early for efficacy.

A Rexy received a positive ACIP recommendation expanding its use to adults aged 50 to 59.

And the Shingrix were. Now researching this vaccine's potential for use beyond shingles, given the increasing number of real-world evidence studies showing a potential protective effect in dementia. We've initiated several research collaborations to explore this effect prospectively.

Tony Wood: Thank you, Emma. Next slide, please. Our number one priority in R&D is to develop transformational specialty medicines and vaccines in areas of high unmet need that positively impact health and deliver significant growth. This is evident in the 14 scale opportunities we have for launch before 2031 and in the progress we're making to expand and accelerate our early-stage pipeline of first and best-in-class assets. We remain focused on four core therapy areas enabled by advanced technologies, talent, and a network of world-class partnerships, and we continue to deepen our expertise in the science of the immune system. This is most recently exemplified with our work to develop IL-5 medicines for lung diseases, which is providing us with a better understanding of the role of the immune system in fibroinflammation, leading us to target diseases beyond the lung towards kidney, liver, and with the potential future application in neuroimmunology.

These include the first-of-its-kind large-scale linkage study with the UK Dementia Research Institute and Health Data Research UK.

Of course, development work in HIV is also a clear priority, and you'll hear more from Deborah on this shortly. Next slide, please.

I'm pleased with the strong momentum in material progress. We're making an R&D investment. I believe we have more and better opportunities with 66 assets and full clinical development, including 16 currently in late stage and 8 with regulatory breakthrough designations already this year.

Our deepening expertise in immunology, use of advanced technologies, and world-class partnerships are delivering results.

We've had 3 FDA approvals so far this year and remain on track for 2 more.

Adding to a record 13 positive Phase 3 readouts. In 2024, we expect another 15 readouts through 2025 and 2026.

Tony Wood: Next slide, please. Based on decades of research, we have a unique understanding of the role that inflammation plays in chronic airway disease. Our focus on the underlying biology of inflammation, notably in COPD, has led to a differentiated pipeline of long-acting options, each strongly supported by human genetics, disease phenotyping, and insights from our own scaled clinical trials. In May, we received FDA approval for Nucala for the treatment of COPD. This is the fifth indication for Nucala in the US. We've also filed Depomucamab, our novel ultra-long-acting IL-5 antagonist for the treatment of asthma and chronic rhinosinusitis with nasal polyps with regulators, and we have a PDUFA date of 16 December. I'm also pleased to report for the first time today positive results from the AGILE continuation study, which further underscores the sustained efficacy and safety over a two-year period of twice-yearly Depomucamab.

And for the remainder of this year, we'll start pivotal studies for four assets. Two of these are in oncology with our B7H ADC in extensive stage small cell lung cancer, and ID RX 42 in second line hepatology. We'll start as soon as Furman and MASH, and in HIV, a pivotal study for our Q4 M Ultra long-acting treatment regimen.

Overall, we have a clear path to extend our leadership in respiratory. Exciting new prospects in immunology and inflammation, and momentum in oncology, alongside major pipeline opportunities to come in infectious disease and HIV.

Next slide, please.

To finish, I'll go back to where I started with our focus on the best-in-class pipeline in areas of huge unmet need, which you can see here.

and where we're making an important difference to the health of billions of people with that. I'll hand over to Luke.

Thanks, Tony. Please turn to the next slide. In Q2, we delivered £8 billion in sales, up 6% versus last year, demonstrating strong execution and demand-driven growth.

Tony Wood: AGILE is an open-label 12-month extension study in severe asthma patients who completed either ZWIFT1 or ZWIFT2. The results show that patients who continue to receive Depomucamab maintained the efficacy achieved in the prior trials. Importantly, patients who crossed over from placebo also saw a reduction in exacerbation rates consistent with results in ZWIFT. As a reminder, the ZWIFT studies demonstrated a 72% reduction in exacerbations requiring hospitalization for patients who received DEPI. I'm also pleased to confirm today that we've started an extensive development program for DEPI as an add-on treatment in COPD. The INJURA trials are now recruiting, and the Vigilant trial designed to evaluate efficacy in earlier-stage disease is planned to start later this year. As the only company with a range of ultra-long-acting mechanisms, specifically IL-5, IL-33, and TSLT, we're competitively placed to lead in this disease.

Growth in the quarter was driven by specialty medicines, up 15%, and strong Shingrix and meningitis demand in Europe, with some offset driven by the expected impact of the Medicare Part D redesign across the portfolio, which is tracking as expected. Next, slide, please.

Specialty medicines continue to be the most important driver of our diversified business, with double-digit growth once again in all therapy areas.

Starting with RI, sales are up 10%, even with the expected tough comparators for new Cara and Ben Lister. This was driven by strong demand.

13% and is now positioned as a preferred therapy in all global guidelines in the quarter. Ula also updated their recommendation for the use of Benlysta up to 3 years, following remission.

Tony Wood: And through our license agreement with Hungary, we're now adding a novel potential best-in-class PD3/4 inhibitor, addressing gaps in the treatment of patients who face continued dyspnea or who are unlikely to receive inhaled corticosteroids or biologics because of their disease profile. Last but not least, the Camlapixent COM1 and COM2 trials remain on track and will be reported together in 2026. Next slide, please. In immunology, we're extending our expertise in inflammation to understand how it leads to fibrosis in the lung, liver, and kidneys to treat, prevent, and stop disease progression. Fibrotic diseases are thought to account for 45% of all deaths worldwide, so there's a major unmet need here.

And new Cara are anti 5 biologics grew 7% in line with expectations. Following an inventory build in Q2 of 2024 and the impact of Medicare Part D redesign, both offset by strong performance in Europe and international. We are very pleased with the label we have in COPD, which I'll cover in a minute.

Moving to our growing oncology portfolio, which is up 42%. Jim Purley for endometrial cancer continues to see increasing patient demand and growing market share in both dMMR and pMMR populations. Following our all-comers approval in the U.S. and Europe, sales were up 91% in the quarter, and Jira sales were up 69%, driven by strong U.S. volume growth, including growing demand from moderate anemic patients. That represents 65% of the market opportunity.

Tony Wood: These conditions are typically seen as difficult to treat, but our work in human genetics and phenotyping, combined with emerging platform technologies, including oligonucleotides, which have a unique ability to modulate gene expression in the liver, is showing real promise. As a result, we now have a growing hepatology pipeline with assets to treat chronic hepatitis B, as well as steatotic liver disease, or SLD, starting in metabolic dysfunction-associated steatohepatitis, or MASH, and alcohol-associated liver disease, or ALD. Let's start with hepatitis B, a considerable market opportunity with large unmet need and limited standard of care. With the paravirusin, an oligonucleotide, we have an exciting opportunity for a functional cure. Promising data from the phase II B clear and B sure studies demonstrate sustained loss of Hep B surface antigen below the level of quantification.

And Blendrip had its first sales in second line multiple myeloma following early launch days in the UK. More on that in a minute, with this strong momentum and the great performance from V that Deborah will cover. We are increasing our full-year specialty guidance, now expected to grow in the low teens percentage.

Next slide, please.

In respiratory, we're very pleased with the strong labor we received from new CAR T and COPD.

We now have an important opportunity to reach a wide spectrum of patients with a blood envelope count starting at 1:50 cells per microliter. A key differentiator for our monthly biology, the label also includes important data showing a 35% reduction in hospitalizations from severe exacerbations. A high-quality data point, as we know that 1 in 2 patients hospitalized from COPD will die within 5 years and that these hospitalizations are responsible for 70% of all COPD-related costs.

Tony Wood: Importantly, new insights from recent epidemiological studies have shown that loss of surface antigen reduces all-cause mortality by up to 62% and the risk of developing liver cancer by up to 89% in HBV patients. We expect to present additional follow-up data from B sure at AASLD later this year. Our phase IIIB well trial continues apace with data expected in the first half of 2026. I'm also delighted to share that the B United phase II study has completed recruitment four months ahead of schedule. This trial is looking at sequential administration of daplasiren and tomolibuturan, followed by BEPI, which will read out in 2027. If positive, it will significantly expand the patient population who could benefit from treatment. As already highlighted, we're also excited to complete the acquisition of Ephimusthermin, or EFI. This adds another phase III ready potential best-in-class medicine to our pipeline.

We continue to look forward to the significant opportunity we have with DeroMap, which has been filed in all major markets for approval in severe asthma and nasal polyps, twice yearly I5.

Both opportunities we expect will expand the market for biologics in this space.

We've also had very positive market research, which shows that 86% of pulmonologists think Deppy could become the standard of care. Additionally, 87% of patients said that they would be likely to use Deppy if supported by an ACP. We look forward to a US FDA decision toward the end of the year on Blend. We're very confident in the opportunity for this important medicine and continue to emphasize the projected overall survival benefit of 33 months compared to standard of care from DREAM 7.

Uh, the premium coordination of care service has already been well received in the UK, following approval and launch in April. We're also pleased to have received approval in Europe, Japan, Canada, the UK, and Switzerland. As you've heard from both Emre and Tony, we are continuing to work with the FDA to bring this important medicine to American patients. I'll now hand over to Deborah to cover HIV.

Tony Wood: EFI is a once-monthly FGF21 analog with phase II data, which demonstrates its potential to reverse liver fibrosis in MASH. We plan to start phase III trials in MASH later this year with plans for further development in ALD. And of course, development of GSK990, our siRNA therapy, to continue for other subsets of patients with SLD. We see these two assets as complementary, providing options to develop both monotherapies and combinations. Let's turn to oncology now. Next slide, please. Here, our momentum continues, and we're rapidly expanding beyond our current focus in hematological and gynecological cancers to treat additional solid tumors. On Blenrep, as Emma has said, the new PDUFA date is the 23rd of October 2025, providing the FDA with time to review additional information provided in support of the application.

HIV portfolio continues to deliver exceptional growth, up 12% in the quarter.

Nine points of growth came from strong, patient demand for our long-acting injectables and Datto.

And three points came from customer, stocking, patterns, and tender phasing.

We saw demand growth across all regions and major markets, particularly the U.S., which grew 14% through double-digit demand growth. We saw not only total share gain outpacing the competition, but Kabanova consistently gaining at least 70% of product switches from competitors.

Devto continues to deliver strong performance, up 23%, and our long-acting injectables, Cab Maneuver and Aptitude, delivered robust growth at 46% and 50%, respectively.

Tony Wood: We're in constructive discussions with the FDA, and while I know you'll want more details, the review process remains confidential, and so I'll update you when we can. Outside the US, we've already received regulatory approvals from Europe, Japan, Canada, the UK, and Switzerland, all pointing to the positive impact this medicine can have for patients with multiple myeloma. Elsewhere in the portfolio, we're progressing multiple development programs. Last year, Gemperli was expanded to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit in these indications. Initial results from the ASIO1 trial in rectal cancer are expected in 2026, with the phase III JAID study in locally advanced head and neck cancer also ongoing. For Ajara, studies are underway to expand the label into MDS, and additional indications are also in planning.

With treatment accounting for 90% of the total $22 billion HIV market, we continue to drive the shift to long-acting injectables.

In Q2, Cabin, Uber, and Aptitude delivered more than 70% of our total growth, driven by the U.S., where they now account for one-third of sales.

Focusing on long-acting injectables for treatment, strong patient preference is reinforced by the LIC, a Phase 3B study shared at the IAS conference this month, showing nearly 90% of newly diagnosed people chose to switch to Kabanova from daily pills after achieving viral suppression. This medicine continues to transform the lives of more than 90,000 people living with HIV.

Posted by over 3 years of real-world data demonstrating more than 99% effectiveness, along with excellent safety and tolerability across broad populations.

Tony Wood: We have a high ambition for our new ADC portfolio, and given the significant potential we see here, we're prioritizing investment. We are developing GSK 227, our B7H3 ADC in lung cancer, and evaluating other solid tumors. We've already received two breakthrough designations from the FDA in relapsed or refractory extensive stage small cell lung cancer and in late line relapsed or refractory osteosarcoma. Early combination data with PDL1 indicates the potential for a chemo-free regimen in first line small cell lung cancer, with more mature data expected in November. And we're on track to start a pivotal study before the end of the year. For GSK584, our B7H4 ADC will start pivotal studies early next year.

We have set a high bar for tolerability with AIT, given by one shot intramuscularly.

This quarter, we initiated the Phase 1 Clarity study in healthy volunteers to evaluate the tolerability of a competitor long-acting injectable against Aptitude's robust profile. We are very optimistic about the outcome and look forward to sharing data at an upcoming conference.

Given our strong and sustained performance, today we are adjusting our 2025 HIV guidance upwards to mid- to high-single-digit percentage growth.

Next slide, please.

Tony Wood: Lastly, earlier this year, we entered into an agreement to acquire IDRX42, a highly selective kit inhibitor being developed as a first and second line therapy for treatment of gastrointestinal stromal tumors, or GIST. IDRX42, now GSK981, has demonstrated activity against all key primary and secondary kit mutations observed in GIST. This breadth of coverage, in addition to high selectivity, which could provide improved tolerability, offers a potential best-in-class profile. We'll start recruitment for a pivotal study in second line before year end. Next slide, please. Within infectious diseases, we're developing prevention and treatment options with broad coverage. Two of our recent FDA approvals exemplify this. Penlenzi, our pentavalent meningococcal vaccine, offers more strain coverage, enabling higher protection from the serious consequences of infection to more teens and young adults.

We continue to progress our industry-leading pipeline with integrating inhibitors at the core and have multiple long-acting options with strong profiles for Q4n, Q6, and self-administered, building on our established treatments. The injectable regimens. We believe four monthly dosing in PrEP and treatment will be important options, delivering longer dosing intervals and ensuring continuity of care.

Our Q4 and prep trial has recruited rapidly and is going well.

The FDA has requested an extra four months of data, which means the study will read out in H2 2026, and we look forward to launching in H1 2027.

At the launch of Q4 and treatment, we expect.

Treatment regimen.

On the market for many years to come.

Looking ahead to our twice-yearly injectables, we're on track to confirm the dosing regimen for Q6 and treatment in 2026. We expect to file and launch both Q6 and for treatments and PrEP between 2028 and 2030.

Tony Wood: And Blechafa is the first new class of antibiotic in over 30 years for the treatment of uncomplicated UTIs, a condition that affects 50% of all women. We're also making progress with other ID assets. Our phase III trial for terbinafine in treatment of complicated UTIs was stopped early for efficacy. Arefsi received a positive ACIP recommendation, expanding its use to adults aged 50 to 59. And with Shingrix, we're now researching this vaccine's potential for use beyond shingles. Given the increasing number of real-world evidence studies showing a potential protective effect in dementia, we've initiated several research collaborations to explore this effect prospectively. These include a first-of-its-kind large-scale linkage study with the UK Dementia Research Institute and Health Data Research UK. Of course, development work in HIV is also a clear priority, and you'll hear more from Deborah on this shortly. Next slide, please.

For treatment, we are particularly excited about the H184, our third generation INSTI, which has the best resistance profile seen today and has the potential to be the backbone of our next generation of HIV treatment regimens with IP cover through at least the end of the next decade.

We also continue to pursue potential cures for HIV. In July, we initiated a first-time in humans study featuring a PAB n6 LS with or without for stem. Severe is currently marketed as Roia.

This work is at an early stage, and we are pleased to bring our scientific expertise to this notoriously difficult area.

With a 10-year head start in long-acting treatment, we are focusing on the next generation of HIV innovation. We remain confident that our pipeline, including 5 planned launches by 2030, will continue to drive performance over the coming decade and beyond.

With that, I will hand back to Luke. Thanks, Deborah. Turning to vaccine sales for Q2, they were £2.1 billion.

Tony Wood: I'm pleased with the strong momentum and material progress we're making in R&D. I believe we have more and better opportunities with 66 assets in full clinical development, 16 currently in late stage, and eight regulatory breakthrough designations already this year. Our deepening expertise in immunology, use of advanced technologies, and world-class partnerships are delivering results. We've had three FDA approvals so far this year and remain on track for two more. Adding to a record 13 positive phase III readouts in 2024, we expect another 15 readouts through 2025 and 2026. And for the remainder of this year, we'll start pivotal studies for four assets. Two of these are in oncology with our B7H3 ADC in extensive stage small cell lung cancer and IDRX42 in second line GIST. In hepatology, we'll start Effinusthermin in MASH, and in HIV, a pivotal study for our Q4M ultra-long-acting treatment regimen.

Up 9%, primarily driven by strong demand in Europe for Shingrix. Managed vaccine Shingrix sales grew 6% in total as our global expansion strategy is delivering, with 72% of our sales now coming from outside the U.S. Growth was driven by launches and national immunization approvals in countries like France and Japan, and we remain confident in the U.S. opportunity starting in Europe. Shingrix sales were up 48%, led by swift uptake in France and strong demand across several countries, including Spain, the Netherlands, Italy, and Greece. In the U.S., penetration is now 42% of the eligible older adult population, achieved in about half the time it took for older adult numerical vaccines.

And with, uh, harder-to-reach patients, the immunization rates have slowed as expected.

Tony Wood: Overall, we've a clear path to extend our leadership in respiratory, exciting new prospects in immunology and inflammation, and momentum in oncology, alongside major pipeline opportunities to come in infectious disease and HIV. Next slide, please. To finish, I'll go back to where I started with our focus on a best-in-class pipeline in areas of huge unmet need, which you can see here, and where we're making an important difference to the health of billions of people. With that, I'll hand over to Luke. Thanks, Tony. Please turn to the next slide. In Q2, we delivered £8 billion of sales, up 6% versus last year, demonstrating strong execution and demand-driven growth.

And in international, the accelerated uptake in Japan following expanded public funding in April was offset by a tough Q2 2024 comparator, which included supply to our co-promotional partner in China, and a rapid uptake in Australia in meningitis. Our portfolio was up 22% with strong double-digit growth, and international growth was primarily driven by Becherer. The only men indicated in infants.

In the U.S., where we have dominant leadership in the men’s adolescent market, we’re excited to introduce our Pentavalent vaccine, PentaMen. We expect this vaccine to simplify immunization schedules and contribute to increasing coverage and protection against serious, life-threatening illness.

Tony Wood: Growth in the quarter was driven by specialty medicines, up 15%, and strong Shingrix and meningitis demand in Europe, with some offset driven by the expected impact of the Medicare Part D redesign across the portfolio, which is tracking as expected. Next slide, please. Specialty medicines continues to be the most important driver of our diversified business with double-digit growth once again in all therapy areas. Starting with RII, sales were up 10%, even with the expected tough comparators for Nucala and Benlysta, and this was driven by strong demand. Benlysta, our treatment for lupus, grew 13% and is now positioned as a preferred therapy in all global guidelines. In the quarter, Euler also updated their recommendation for use of Benlysta up to three years following remission.

Recommendations for adults aged 50 to 59 at increased risk in the current vaccine environment. We continue to expect this market will take time to build, but with our strong clinical profile and the most vulnerable populations, we remain confident long-term in the importance of this vaccine.

And finally, our broad portfolio of established vaccines grew 6%, primarily due to favorable CDC stockpile movements and forex in the US.

Tony Wood: And Nucala, our anti-IL-5 biologic, grew 7% in line with expectations following an inventory build in quarter two of 2024, and the impact of Medicare Part D redesign, both offset by strong performance in Europe and internationally. We are very pleased with the label we have in COPD, which I'll cover in a minute. Moving to our growing oncology portfolio, which is up 42%, Gemperli for endometrial cancer continues to see increasing patient demand and growing market share in both DMMR and MMRP populations following our all-comers approval in the US and Europe, up 91% in the quarter. And Ajara sales were up 69%, driven by strong US volume growth, including growing demand from moderate anemic patients that represent 65% of the market opportunity. And Blenrep had its first sales in second line multiple myeloma following early launch days in the UK, and more on that in a minute.

OEL are vaccines. Business is performing well, admits a challenge in the external environment and is driven by the good H1 performance. We are increasing our outlook for vaccine sales today to decline low single digits to stable, and we remain confident in the medium and long-term prospects of this business and pipeline. Next slide, please. Turning to General Medicines, which was down 6% as expected, following a very tough comparative for Trilogy in Q2 of last year. As you may remember, Trilogy was up 41% in Q2 24, due in large part to significant adjustments in returns and rebates. This quarter, Trilogy grew 1% in the US and 4% globally, despite the tough comp and pricing headwinds from the Medicare Part D redesign. Trilogy is now in its 8th year on the market, and we are continuing to see all-time high shares with room to grow.

Beyond Trilogy, the rest of the general medicine portfolio was down, reflecting continued generic competition across the portfolio and adjustments in rebates and returns as expected.

Tony Wood: With this strong momentum and the great performance from V that Deborah will cover, we are increasing our full-year specialty guidance, now expected to grow in the low teens percentage. Next slide, please. In respiratory, we're very pleased with the strong label we received for Nucala and COPD. We now have an important opportunity to reach a wide spectrum of patients with a blood eosinophil count starting at 150 cells per microliter, a key differentiator for our monthly biologic. The label also includes important data showing a 35% reduction in hospitalizations from severe exacerbations, a high-quality data point, as we know that one in two patients hospitalized from COPD will die within five years, and that these hospitalizations are responsible for 70% of all COPD-related costs.

We continue to expect sales to be broadly stable in 2025, and look forward to the opportunity we have in adding anti-infectives into this part of the business. With the approval of Blue Jeepers for uncomplicated urinary tract infections in the US, which we will launch later this year, we have also seen progress on TV panum, as Cheney highlighted, an important oral option to keep complicated urinary tract infection patients at a hospital. I'll now hand over to Julie.

Thank you, Luke, and good afternoon, everyone. Next slide, please.

Starting with the income statement for the quarter, with the growth rate stated at CER.

GSK continues to build momentum in 2025, with sales increasing 6%, driven by continued strong specialty performance complemented by growth in vaccines.

Cost of sales for the quarter grew 7%, ahead of sales due to pricing impacts and supply chain optimization charges.

Core operating profit grew 12%, with strong leverage in the quarter delivered through a 1% reduction in SG&A, demonstrating our disciplined returns-based approach and a 70% increase in royalties due to the upfront receipt from the IP settlement announced in April.

Tony Wood: We continue to look forward to the significant opportunity we have with Depomucamab, our twice-yearly IL-5, which has been filed in all major markets for approval in severe asthma and nasal polyps. Both are opportunities we expect will expand the market for biologics in this space. We've also had very positive market research, which shows 86% of pulmonologists think DEPI could become standard of care, and 87% of patients said that they would be likely to use DEPI if supported by an NCP. And we look forward to a US FDA decision toward the end of the year. On Blenrep, we're very confident in the opportunity for this important medicine and continue to emphasize the projected overall survival benefit of 33 months compared to standard of care from Dream 7. Our premium coordination of care service has already been well received in the UK following approval and launch in April.

Corey Pierce grew 15%, continuing to demonstrate our track record of delivery margin leverage, enhanced by lower interest charges, as well as the share buyback.

Turning to Total results, growth of 33% was largely driven by a favorable V CCL movement, predominantly due to currency, partially offset by intangible asset impairments. Next slide, please.

Tony Wood: We're also pleased to have received approval in Europe, Japan, Canada, the UK, and Switzerland. And as you have heard from both Emma and Tony, we're continuing to work with the FDA to bring this important medicine to American patients. I'll now hand over to Deborah to cover HIV.

Emma Walmsley: Thank you, Luke. Our HIV portfolio continues to deliver exceptional growth, up 12% in the quarter. Nine points of growth came from strong patient demand for our long-acting injectables and Dervato, and three points came from customer stocking patterns and tender phasing. We saw demand grow across all regions and major markets, particularly the US, which grew 14% through double-digit demand growth and where we saw not only total share gain outpacing the competition, but Cabinuva consistently gaining at least 70% of product switches from competitors. Dervato continued to deliver strong performance, up 23%, and our long-acting injectables, Cabinuva and Aperture, delivered robust growth at 46% and 50% respectively. With treatment accounting for 90% of the total 22 billion HIV market, we continue to drive the shift to long-acting injectables.

This chart illustrates the margin improvement year on year. The operating margin improved in the quarter by 180 basis points, driven by SG&A and royalties. While we continue to invest competitively behind product launches, SG&A improved the margin by 190 basis points due to phasing between the quarters and accelerated productivity improvements. As I mentioned, royalties were driven by the RSV IP settlement, the income from which is being reinvested in R&D this year, with priority projects accelerating this quarter. Finally, while the portfolio and margin continue to benefit from the transition towards specialty, the Q2 fall in the gross margin was predominantly driven by lower RA benefits year on year and by charges associated with supply chain optimization.

Next slide, please.

Turning to the cash flow with commentary before the one-off impact of the Zantac payment.

Cash generated from operations was £3.9 billion at the half, improving by more than £1 billion and demonstrating our continued focus on cash discipline as we remain on track for more than £10 billion CGFO in 2026.

The improvement year to date is driven by increased operating profit and favorable movements in our operations, partially offset by increased working capital driven by higher RXV and Shingrix collections last year.

Free cash flow improved by £1.3 billion, driven by strong CGFO and the favorable phasing of tax payments.

Emma Walmsley: In Q2, Cabinuva and Aperture delivered more than 70% of our total growth, driven by the US, where they now account for one-third of sales. Focusing on long-acting injectables for treatment, strong patient preference is reinforced by Valixion, a phase IIIB study shared at the IAS conference this month, showing nearly 90% of newly diagnosed people chose to switch to Cabinuva from daily pills after achieving viral suppression. This medicine continues to transform the lives of more than 90,000 people living with HIV. Aperture saw strong growth in the quarter, and we expect it to continue to grow in H2 in the US, bolstered by over three years of real-world data demonstrating more than 99% effectiveness, along with excellent safety and tolerability across broad populations. We have set a high bar for tolerability with Aperture, given by one shot intramuscularly.

This year, we have totaled 124 million pounds, and we expect the remaining $1.1 billion to be paid through the second half. Next slide, please.

Turning to capital allocation, we continue to deploy cash in a disciplined manner, underpinned by a strong balance sheet in line with our framework.

Our net debt to core EBITDA remains broadly aligned with this time last year.

Our priority is always to invest for growth evidence, by the increase in investment in R&D together with the ongoing BD.

In the first half, we had outflows relating to a number of deals, including the acquisition of RX, and we will continue to look for opportunities, particularly in specialty, consistent with the size and frequency of recent deals.

Emma Walmsley: This quarter, we initiated the phase one clarity study in healthy volunteers to evaluate the tolerability of a competitor's long-acting injectable against Aperture's robust profile. We are very optimistic about the outcome and look forward to sharing data at an autumn conference. Given our strong and sustained performance today, we are adjusting our 2025 HIV guidance upwards to mid to high single-digit percentage growth. Next slide, please. We continue to progress our industry-leading pipeline with integrated inhibitors at the core and have multiple long-acting options with strong profiles for Q4M, Q6M, and self-administered. Building on our established three-monthly injectable regimens, we believe four-monthly dosing in prep and treatment will be important options, delivering longer dosing intervals and ensuring continuity of care. Our Q4M prep trial has recruited rapidly and is going well.

We have also made over £2 billion in shareholder distributions in the first half through the dividend and share buyback programme, which is progressing at pace, with more than £800 million executed so far. With a total of £1.3 billion expected to be completed by the end of the year, please note in the second half. Net debt is expected to include almost £3 billion of outflows relating to the settlement of Zantac and the completion of FMS Furman.

And the hungry collaboration, together with the ongoing share buyback. Next slide, please.

GSK's momentum continues to build, and we are pleased with the performance this year.

We now expect to deliver towards the top end of our guidance ranges on sales, operating profit, and EPS. We are adjusting our full year guidance for specialty, HIV, and vaccines upwards.

Regarding our 2025 P&L guidance, in line with our capital allocation priorities, we expect gross margin to benefit from product mix for the full year.

Emma Walmsley: The FDA has asked for an extra four months of data, which means the study will read out in H2 2026, and we look forward to launching in H1 2027. At the launch of Q4M treatment, we expect to have the only complete long-acting injectable treatment regimens on the market for many years to come. Looking ahead to our twice-yearly injectables, we're on track to confirm the dosing regimen for Q6M treatment in 2026 and expect to file and launch both Q6M for treatments and prep between 2028 and 2030. For treatment, we are particularly excited about the H1H4, our third-generation instinct, which has the best resistance profile seen to date and has the potential to be the backbone of our next generation of HIV treatment regimens with IP cover through at least the end of the next decade. We also continue to pursue potential cures for HIV.

We are accelerating investment in the pipeline and now expect our R&D to grow ahead of sales.

We also remain committed to a low single-digit percentage growth in SG&A for the full year.

Whilst there will be a step up in investment in Q3 behind our upcoming launches, we will also see an acceleration of SG&A productivity initiatives, with the associated charges and benefits in the remainder of the year.

And finally, net interest expense is now expected to be lower than previously guided at $550 million to $600 million due to the later phasing of Zantac payments.

Our guidance is inclusive of tariffs inactive, thus far.

And the European tariffs indicated this week.

Obviously, more details are set to follow. But as we've said previously, we are positioned to respond with mitigation actions identified and confirm our guidance towards the top end of the range this year.

Emma Walmsley: In July, we initiated entrance, a first-time in humans study featuring IPNab N6LS with or without fosfosinovir, currently marketed as Rukobia. This work is at an early stage, and we are pleased to bring our scientific expertise to this notoriously difficult area. With a 10-year head start in long-acting treatments, we are focusing on the next generation of HIV innovation. We remain confident that our pipeline, including five planned launches by 2030, will continue to drive performance over the coming decade and beyond. With that, I will hand back to Luke.

Looking beyond, we remain very confident in our medium- and longer-term outlooks to 2026 and 2031. Next slide, please.

Moving to our road map, which illustrates our progress towards major milestones and upcoming value unlocks, we have made good progress through the first half on our priority assets.

Looking forward, we expect this momentum to accelerate. We continue to plan for launches in H2 with Blenrep VA and Penmani Addington, and the new policy OPD.

The FDA regulatory decision for de Moab is due in December this year.

Tony Wood: Thanks, Deborah. Turning to vaccines, sales for Q2 were £2.1 billion, up 9%, primarily driven by strong demand in Europe for Shingrix and our meningitis vaccines. Shingrix sales grew 6% in total, as our global expansion strategy is delivering with 72% of our sales now coming from outside the US. Growth was driven by launches and national immunization approvals in countries like France and Japan, and we remain confident in the ex-US opportunity. Starting in Europe, Shingrix sales were up 48%, led by swift uptake in France and strong demand across several countries, including Spain, the Netherlands, Italy, and Greece. In the US, penetration is now 42% of the eligible older adult population, achieved in about half the time it took for older adult pneumococcal vaccines. And with harder-to-reach patients, the immunization rates have slowed as expected.

And of the 14th scale opportunities that Emma mentioned, we will have pivotal trial readouts related to 6 of these over the coming 18 months.

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

Thanks Julie.

To summarize our results today confirmed.

Our portfolio is demonstrating quality and strength, and we now expect to be towards the top end of our financial guidance for 2025 looking beyond. We're excited by the prospects in our pipeline and remain highly confident in our long-term outlook.

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

Thank you, Emma. I would like to remind everyone to please raise their hand to ask a question.

Tony Wood: And an international accelerated uptake in Japan following expanded public funding in April was offset by a tough Q2 2024 comparator, which included supply to our co-promotion partner in China and a rapid uptake in Australia. In meningitis, our portfolio was up 22%, with strong double-digit growth across Europe and international, driven primarily by Bexero, the only MenB indicative instance. In the US, where we have dominant leadership in the MenB adolescent market, we're excited to introduce our pentavalent vaccine, PenMenB. We expect this vaccine to simplify immunization schedules and contribute to increasing coverage and protection against serious life-threatening illness. Turning to RSV, obviously, we are pre-season, but RxV sales increased 13%, maintaining market leadership in the US older adult segment and benefiting from strong uptake in Germany.

Comes from Simon Baker.

Go ahead, Simon.

Polluters and you can speak. Can you hear me now? Consultation? Apologies for that. Um, yeah, two questions about me, please. Um, firstly, um, just a clarification on Kamala Pixcent. Um, Tony, you said they would both report in 2026.

Tony Wood: In the US, we're also pleased to see that earlier this month, the CDC confirmed the ACIP recommendation for adults aged 50 to 59 at increased risk. In the current vaccines environment, we continue to expect this market will take time to build, but with our strong clinical profile in the most vulnerable populations, we remain confident long-term in the importance of this vaccine. And finally, our broad portfolio of established vaccines grew 6%, primarily due to favorable CDC stockpile movements for Infrex PDX in the US. Overall, our vaccines business is performing well amidst a challenging external environment. And driven by the good half-one performance, we are increasing our outlook for vaccine sales today to decline, low single digit to stable, and we remain confident in the medium and long-term prospects of this business and pipeline. Next slide, please.

Um slide 32 is still showing calm 1 read out in 20 in h225. So when you said report, do you mean the full data and we will still get a calm 1 headline, press release in 2025. And then the second question um, was was related to uh, to blenrep um, we like you were assuming this, this is simply a, a potential delay, uh, rather than anything else. So, I just wanted to get your thoughts on what impact that has firstly on 2031 and the composition of the 40 billion. Uh, if those blend revenues are pushed out slightly and also what it means for 2028, where the contribution from blend. Now, looks like it will be smaller and therefore the impact from the dollar Tegra. Uh, pattern expire will be greater just how that what the magnitude of that is and also how that influences your um m&a um uh plans going forward. Thanks so much.

Tony Wood: Turning to general medicines, which was down 6% as expected following a very tough comparator for Trelegy in Q2 of last year. As you may remember, Trelegy was up 41% in Q2 24, due in large part to significant adjustments in returns and rebates. This quarter, Trelegy grew 1% in the US and 4% globally, despite the tough comp and pricing headwinds from the Medicare Part D redesign. Trelegy is now in its eighth year on the market, and we are continuing to see all-time high shares with room to grow. Beyond Trelegy, the rest of the general medicines portfolio was down, reflecting continued generic competition across the portfolio and adjustments in rebates and returns as expected.

Tony Wood: We continue to expect sales to be broadly stable in 2025 and look forward to the opportunity we have in adding anti-infectives into this part of the business, with the approval of Blue Jepper for uncomplicated urinary tract infections in the US, which we will launch later this year. We have also seen progress on Tevipenem, as Tony highlighted, an important oral option to keep complicated urinary tract infection patients out of hospital. I'll now hand over to Julie.

Thanks. Well, I, I'll turn you in a second just to comment quickly on on camera pixon but to be really clear. Uh, Simon, we um, are very pleased, uh, to have an updated PDF for dates. Uh, in October, there is absolutely no change to our expectations uh, around uh, the ramp of Glenn rep. We're really pleased with the, I was hoping to get into more than 10 markets actually, by the end of this year, we're working hard and constructively with the FDA to be able to bring this to American, uh, patience too. So, no change, uh, and fully confident in our, whether it's our 28 outlooks, or our 31 outlooks. And as, you know, we keep adding to them with, uh, uh, new prospects and and ongoing BD and specifically on your question on BD, you know, it's quite exciting to me that 3 of the 4 pivotal trials that are starting later this year are whether it's on uh, Fe or RX or, you know, our next generation of adcs are from, you know, great, BD that we brought in of course we

Julie Brown: Thank you, Luke, and good afternoon, everyone. Next slide, please. Starting with the income statement for the quarter, with growth rates stated at CER. GSK continues to build momentum in 2025, with sales increasing 6%, driven by continued strong specialty performance, complemented by growth in vaccines. Cost of sales for the quarter grew 7% ahead of sales due to pricing impacts and supply chain optimization charges. Core operating profit grew 12%, with strong leverage in the quarter delivered through a 1% reduction in SG&A demonstrating our disciplined returns-based approach and a 70% increase in royalties due to the upfront receipt from the IP settlement announced in April. Core EPS grew 15%, continuing to demonstrate our track record of delivering margin leverage and enhanced by lower interest charges, as well as the share buyback.

We announced 10 Brewery this week, which is a really strategic play to accelerate early-stage research, with a headline asset that might be best in class on the PD, uh, 34s for COPD as well. So, lots going on in BD, and you know, we'll continue with the kind of pace and scale we have been, um, uh, but, you know, uh, no update at all except for reiterated confidence in terms of our outlooks and plans to add to them.

Honey. Anything, uh, you want to say on camera? Yeah, it's Simon. Thanks for the question. And, um, just as an update and clarification here, as I said before, cam 2 is still recruiting. We're anticipating data in mid-2026. You'll also appreciate that typically we only disclose Phase 3 studies involving 2 studies once both are completed. And so, the formal disclosure associated with Comm 1 and cam 2 will be in line with the Constitution. Right? Thank you. Next question, please.

Next question comes from James Gordon from JP Morgan. James, please go ahead.

Julie Brown: Turning to total results, growth of 33% was largely driven by a favorable V of CCL movement, predominantly due to currency, partially offset by intangible asset impairments. Next slide, please. This chart illustrates the margin improvement year on year. The operating margin improved in the quarter by 180 basis points, driven by SG&A and royalties. Whilst we continue to invest competitively behind product launches, SG&A improved the margin by 190 bps due to phasing between the quarters and accelerated productivity improvements. As I mentioned, royalties were driven by the RSV IP settlement, the income from which is being reinvested in R&D this year, with priority projects accelerating this quarter. Finally, whilst the portfolio and margin continue to benefit from the transition towards specialty, the Q2 fall in the gross margin was predominantly driven by lower RAR benefits year on year and by charges associated with supply chain optimization.

Hello James Gordon JP Morgan. Thanks for taking the questions. First question was also on blame so a busy few weeks of the odac and then sounds like subsequent data added after the odac and then some Personnel changed that FDA. We've been able to start leaving. But so with that ask you what the extra data is just what is GS latest confidence in getting Glen reproved in the in the US this year. And uh, also, if is how important is blend rep Us in keeping the margin flat, through HIV and Louise starting in 28. So if you didn't have us blend out, would you still be able to keep the margin flat but that's the first question please. And then the second question that pd3 Ford looks interested in for the Henry deal. So I think based on like 10 billion dollars to get Verona's pde3 for but that is already on the market and you're paying about 500 million pounds, but it's quite a bit earlier.

So is the key differentiation that yours is DPI? LEDs is nebulizer, or are there other areas where it's differentiated? And you're only paying about 5% more for Mercedes. So is it just how far you are from market? It looks like a very good deal, but it depends on how differentiated it is.

Well, we definitely agree. It's a very good deal. You know, the market deals are not about how much you spend, but rather the kind of returns you can get. We do believe we have a potentially best-in-class asset here in a field we know a lot about.

Julie Brown: Next slide, please. Turning to the cash flow, with commentary before the one-off impact of Zantac payments. Cash generated from operations was £3.9 billion at the half, improving by more than a billion and demonstrating our continued focus on cash discipline as we remain on track for more than 10 billion CGFO in 2026. The improvement year to date is driven by increased operating profit and favorable movements in RAR, partially offset by increased working capital, driven by higher RxV and Shingrix collections last year. Free cash flow improved by £1.3 billion, driven by strong CGFO and the favorable phasing of tax payments. Zantac payments so far this year have totaled £124 million, and we expect the remaining £1.1 billion to be paid through the second half. Next slide, please.

As Tony said, we know you've got a lot of questions about that, but we hope everybody on the call understands how much we are committed to respecting the confidentiality of this.

Julie Brown: Turning to capital allocation, we continue to deploy cash in a disciplined manner and underpinned by a strong balance sheet in line with our framework. Our net debt to core EBITDA remains broadly aligned with this time last year. Our priority is always to invest for growth, evidenced by the increasing investment in R&D together with the ongoing BD. In the first half, we had outflows relating to a number of deals, including the acquisition of IDRX, and we will continue to look for opportunities, particularly in specialty, consistent with the size and frequency of recent deals. We have also made over £2 billion in shareholder distributions in the first half through the dividend and share buyback program, which is progressing at pace with more than 800 million executed so far and with a total of 1.3 billion expected to be completed by the end of the year.

Process. Uh, we are in constructive dialogue. Um, uh, we have high confidence in our data. We're answering uh, questions and uh, you know, adding uh, more to that. And we will update you uh, when when we can, um, and and just to reiterate, you know, we don't subsegment our Peak year sales by country. Obviously, uh, the US is important, but we're really pleased to have added, you know, uh, by the way, since the odac the across the board, Europe approval, the Canada approval, to the UK, to Japan. And, uh, you can rest assure that Lucas is ramping up, um, for launch preparations, of course, going slow to go big. Um, and, you know, Blair is without doubt, an important medicine we are working towards, um, the, uh, us approval. We want to bring this for American patients, when you think of this overall survival data in,

And a head-to-head study against the standard of care. When you think that 70% of Myoma patients are in communities. And this is a medicine that it allows people to be treated in in, in communities. Uh, so it will keep the conversation going there. I'll see whether Tony wants to add anything at all. He's shaking his head anything you want to say,

Just just simply.

You were in constructive dialogue, but we want to respect the confidentiality of that interaction. I'll update you as soon as I can. Great, thanks. And just because we want to get through as many questions as possible.

Julie Brown: Please note, in the second half, net debt is expected to include almost £3 billion of outflows relating to the settlement of Zantac, the completion of Effinusthermin, and the Hengrui collaboration together with the ongoing share buyback. Next slide, please. GSK's momentum continues to build, and we are pleased with the performance this year. We now expect to deliver towards the top end of our guidance ranges on sales, operating profit, and EPS, and we are adjusting our full-year guidance for specialty, HIV, and vaccines upwards. Regarding our 2025 P&L guidance, in line with our capital allocation priorities, we expect gross margin to benefit from product mix for the full year. We are accelerating investments in the pipeline and now expect R&D to grow ahead of sales. We also remain committed to a low single-digit percentage growth in SG&A for the full year.

I would respectfully suggest that we're not going to go much further than that on Blenrep today. Next question. Please, do you want to do the—oh, sorry? The 3, 4. Yeah.

Tony, maybe Luke would be good.

Cover while you like the profile and I can yeah I I'll I'll start with why I like the collaboration um for stop this. For 500 million is also um dedicated towards options to the other 11 um in this Innovative um, potential medicines that we have covering our ini and and oncology, um, look let me just describe the the profile as a of the molecule itself. I I was described it in terms of its pd3420q.

Julie Brown: Whilst there will be a step up in investment in Q3 behind our upcoming launches, we will also see an acceleration of SG&A productivity initiatives with the associated charges and benefits in the remainder of the year. And finally, net interest expense is now expected to be lower than previously guided at 550 to 600 million due to the later phasing of Zantac payments. Our guidance is inclusive of tariffs enacted thus far and the European tariffs indicated this week. Obviously, more details are set to follow, but as we've said previously, we are positioned to respond with mitigation actions identified and confirm our guidance towards the top end of the range this year. Looking beyond, we remain very confident in our medium and longer-term outlooks to 2026 and '31. Next slide, please.

More potent across that and has demonstrated both clinically and pre-clinical both on Bronco dilation and anti-inflammatory effect. That reduction in dose is important when 1 consider the um optionality for a DPI. And as Emma said you know we have an extensive um experience there based on our own DPI portfolio and I'm looking forward to um developing that molecule and partnership. And you know we we seek potential really across the goal um framework as as an add-on therapy looking for. You want to add a bit more? Yeah, I mean I we've obviously looked at this class for a while for a couple of years now, we like it.

Um, you know, I think each initial uptake is pretty clear. I think about 50% of the use, as in, uh, very severe patients on top of standard of care, triple, etc. Uh, but I think there will be a threshold where nebulization and the price start to retard, let the hypothesis, anyway, um, starts to retard things. So an alternative, if you know classical delivery.

Julie Brown: Moving to our roadmap, which illustrates our progress towards major milestones and upcoming value unlocks, we have made good progress through the first half on our priority assets. Looking forward, we expect this momentum to accelerate. We continue to plan for launches in half two with Blenrep, Blue Jepper, and PenMenB, adding to Nucala COPD. The FDA regulatory decision for Depomucamab is due in December this year, and of the 14 scale opportunities that Emma mentioned, we will have pivotal trial readouts related to six of these over the coming 18 months. And with that, I will hand back to Emma to close.

Um, approach which is very synergistic with the rest of the portfolio is exciting. Then the final thing I'd say is it's a good sign for COPD and new Kara and COPD because clearly there's an appetite for new mechanisms in uh particularly the more severe COPD population. Yeah. I mean and we're really you know, believe that the agility in fact, the aggression we've been showing uh on partnering for BD as of assets as of China whether it's the ADC deal we did or the long-acting key slip or now adding this and

Of course, you know, some great science. We all know what's happening in the biotech industry there. But then we can pick up partnering and then roll through our global.

China clinical, um, uh, network and of course, uh, manufacturing. If that's successful, next question, please.

Emma Walmsley: Thanks, Julie. To summarize, our results today confirm GSK's continued strong momentum and meaningful R&D progress for patients and for shareholders. Our portfolio is demonstrating quality and strength, and we now expect to be towards the top end of our financial guidance for 2025. Looking beyond, we're excited by the prospects in our pipeline and remain highly confident in our long-term outlooks. With that, I'll now open up the call for Q&A with all the team.

The next question comes from Michael Lin from Jeffrey's. Please go ahead, Michael.

Thank you for taking my questions. Two places: one for Julie and one for Luke. Uh, Julie, you're up to talk to the supply chain.

Constantin Fest: Thank you, Emma. I would like to remind everyone to please raise their hand to ask a question. First question comes from Simon Baker. Please go ahead, Simon.

Look. Can you just clarify what those costs might mean for the second half of the relevant or not? And a question for Luke nucala COPD, um you've got 500 million Peak sales on the slide now, I saw it in the past. You talked to 5002 billion, it might be wrong but have your expectations come down for that relative to previous communication. Thank you, definitely not I'll say before Luke after your question. Um and Julie do you also put some recognizing, remember that we have included?

Deborah Waterhouse: Simon, you have been unmuted and you can speak. Yeah.

Simon Baker: Can you hear me now?

Deborah Waterhouse: Yeah, we can hear you.

Simon Baker: Thank you. Apologies for that. Yeah, two questions if I may, please. Firstly, just a clarification on Camlapixent. Tony, you said they would both report in 2026. Slide 32 is still showing COM1 readout in H2 25. So when you said report, do you mean the full data? And we will still get a COM1 headline press release in 2025. And then the second question was related to Blenrep. We, like you, are assuming this is simply a potential delay rather than anything else. So I just wanted to get your thoughts on what impact that has, firstly, on 2031 and the composition of the 40 billion if those Blenrep revenues are pushed out slightly. And also what it means for 2028, where the contribution from Blenrep now looks like it will be smaller and therefore the impact from the dollar Tegraveer patent expired will be greater.

Um, in our guidance, not only those inactive but those indicated in terms of tariffs. So, as that settles out with a bit more details to come, you know, we'll have more specificity. But Julie, you want to pick up on gross margin and then Luke. Yeah, sure. Thank you very much for the question. Um, so in terms of gross margin, we do anticipate some accretion this year. As you know, we took a charge for supply chain efficiencies in Q4 of last year of over $150 million. So we will be comping that coming up before the quarter. But nevertheless, the big point is that the specialty growth, which is very considerable, is driving an improvement in our gross margin. If all else was equal, you would see that coming through. What you see is causing some turbulence in the gross margin is, one, supply chain optimization charges that are going through, and then the second one is, as Emma just alluded to, is tariffs. Obviously, we haven't had any tariffs in the first half. We are anticipating some coming in the second half, and that will lower the growth.

Margin slightly, but even with the ones that have either been announced or indicated, we still see the opportunity for gross margin accretion coming through mix, right? Thanks, Luke. Yeah, and thanks, Michael. I think $500 million is fair, but of course, we are going to aim above that. Um.

Simon Baker: Just how that, what the magnitude of that is, and also how that influences your M&A plans going forward. Thanks so much.

Deborah Waterhouse: Thanks. I'll turn in a second just to comment quickly on Camlapixent. But to be really clear, Simon, we are very pleased to have an updated producer date in October. There is absolutely no change to our expectations around the ramp of Blenrep. We're really pleased with the, we're hoping to get into more than 10 markets actually by the end of this year. We're working hard and constructively with the FDA to be able to bring this to American patients too. So no change and fully confident in our, whether it's our 28 outlooks or our 31 outlooks. And as you know, we keep adding to them with new prospects and ongoing BD.

If I, if I look at, you know, initial signs, uh, we're already ahead of where the duplicate was at the same point in its launch with new patient starts. So it's a good sign. Uh, we don't, I mean the lead indicator is a positive. So um positions clearly like the reduction in hospitalization and Ed Department visits um and that certainly resonates with them. Um, we're also interestingly winning in terms of the perception in the lower EOS patient as well, which is sort of naturally, historically due he's hunting ground. Um, which is encouraging, and if you look at the market research, we've got again early days, but 67% of pulmonologists said, they're likely to prescribe

Your car and see.

Deborah Waterhouse: And specifically on your question on BD, you know, it's quite exciting to me that three of the four pivotal trials that are starting later this year, whether it's on Effi or IDRX or our next-gen of ADCs, are from, you know, great BD that we brought in. Of course, we announced Hengrui this week, which is a really strategic play to accelerate early-stage research and with a headline asset, which might be best-in-class on the PD 34 for COPD as well. So lots going on in BD and, you know, we'll continue at the kind of pace and scale we have been. But, you know, no update at all except for reiterated confidence in terms of our outlooks and plans to add to them. Tony, anything you want to say or tell me?

And prefer it versus only 30% with your pixel, um, and you know, a really good execution. So far, we've seen 91% of our key customers with a really good frequency, so bang on there. I think balancing that back to your question is, you know, pulmonologists historically have not been, you know, as aggressive as maybe the evidence would support in terms of biologic penetration. So, um, once we get more robust numbers, which will be, you know, IQ is the Quant for the lag indicators.

And we'll have a better picture, but I think it's a good start. We'll give you a fuller, updated Q3 when we've got data, which of course is, you know, what counts. You know, overall, and you know, the only other thing I'd say on.

this 1 is

Luke Miels: Yeah, Simon, thanks for the question. And just as an update and clarifying here, as I said before, COM2 is still recruiting. We're anticipating data in mid-year '26. You'll also appreciate that typically we only disclose phase III studies involving two studies once both are completed. And so the formal disclosure associated with COM1 and COM2 will be in line with the COM2 schedule.

What we're aiming to do is be, you know, indisputable leaders in the COPD medicines. That is the strategy that Tony has laid out with a comprehensive portfolio that we've added to in order to be able to segment and treat this enormous burden of disease, you know, affecting more than 300 million people.

The leading cause of death.

70%, as Luke said, of the cost.

Scholar is the only medicine.

Deborah Waterhouse: Right. Thank you. Next question, please.

Constantin Fest: Next question comes from James Gordon from JP Morgan. James, please go ahead.

Tony confirmed the star of the, uh, Deputy uh, COPD trial. So, one of the things that might continue over time, the patients' cells of new Cara is bringing a 6-monthly IL-5 to COPD. And then, of course, we've got the, you know, long reaction. We've got the whole portfolio of, um, of assets that we've already stopped talking about, so exciting start.

James Gordon: Hello, James Gordon, JP Morgan. Thanks for taking the questions. First question was also on Blenrep. So a busy few weeks with the ODAC, and then it sounds like subsequent data added after the ODAC, and then some personnel changes at FDA with Blenrep decidedly leaving. So without asking what the extra data is, just what is GSK's latest confidence in getting Blenrep approved in the US this year? And also, how important is Blenrep US in keeping the margin flat through HIV/LOE starting in '28? So if you didn't have US Blenrep, would you still be able to keep the margin flat? That's the first question, please. And then the second question, the PDE34 that looks interesting for the Hengrui deal. So I think Merck pays more like $10 billion to get Verona's PDE34, but that is already on the market.

I think we've confirmed and reiterated that, uh, half a billion for this one, but let's see how it goes. Next question, please.

Next question comes from section, Jane.

America.

Section. Please go ahead.

James Gordon: And you're paying about £500 million, but it's quite a bit earlier. So is the key differentiation that yours is PPI and theirs is nebulizer? Or were there other areas where it's differentiated and you're only paying about 5% what Merck did? So is it just how far you are from market? It looks like a very good deal, but it depends how differentiated it is.

On blender, just want to understand why the data you've submitted.

You wouldn't have used, as part of the Adcom debate, if it was material enough to shift the debate, you knew was coming. Thank you.

Sorry, I didn't mean to skip that on purpose, but I didn't actually hear the third question on Blenrep. Could you repeat it?

Deborah Waterhouse: Well, we definitely agree it's a very good deal. And the mark of deals is not how much you spend. It's the kind of returns you can get. And we do believe we have a potentially best-in-class asset here in a field we know a lot about and adding to that COPD portfolio. I mean, I think there are about seven questions in that. But in your first point on Blenrep, and just for everybody, as Tony said, we know you've got a lot of questions about that. But we hope everybody on the call understands how much we are committed to respecting the confidentiality of this process. We are in constructive dialogue. We have high confidence in our data. We're answering questions and adding more to that. And we're updating you when we can. And just to reiterate, you know, we don't subsegment our PTS sales by country, obviously.

Uh, why data that you've submitted? Um, you wouldn't have used as part of the AdCom debate. If it's material enough to shift the FDA's view on a debate that you knew was coming, giving you the briefing documents well ahead of the actual AdCom. Thanks.

Yeah, I'm waiting for

Deborah Waterhouse: The US is important, but we're really pleased to have added, you know, by the way, since the ODAC, the across-the-board Europe approval, the Canada approval to the UK, to Japan. And you can rest assured that Luke is ramping up the launch preparations. Of course, going slow to go big. And, you know, Blenrep is without doubt an important medicine. We are working towards the US approval. We want to bring this for American patients. When you think of this overall survival data in a head-to-head study against the standard of care, when you think that 70% of myeloma patients are in communities, and this is a medicine that allows people to be treated in communities. So we'll keep the conversation going there. I'll see whether Tony wants to add anything at all. He's shaking his head. Anything you want to say?

um so uh good try but uh but Luke would you like to answer the first 2 questions or Ambitions around Dei and and Shing Rick's curve. Thanks and welcome back session. Um, yeah, look, I think I'm Derpy, you know, a lot of excitement, I think, for anyone that's attended and academic meeting with the data has been presented, I think there's a lot of enthusiasm here and I'll quite some numbers for the market research, um, inside, of course. Um, the track record of this team with you. Carla and execution will stop is very good. Um, there's a high excitement there. I think with Physicians is also High anticipation. Um, you know, we've got a really robust data here in controlled studies, and I think, most people can, can can see that efficacy, but also have the imagination to understand and the Real Environment with less supervision that data, hopefully should improve and we've got a program to to to capture that. Um look, I won't go into the strategy and positioning but

You know, the testing response is really clear. When we've taken that profile, that strategy, to pulmonologists and allergists, 94% of them are motivated to prescribe a product.

Luke Miels: Just simply, again, to emphasize that obviously we're in constructive dialogue, but we want to respect the confidentiality of that interaction. I'll update you as soon as I can.

Deborah Waterhouse: Great. Thanks. And just because we want to get through as many questions as possible, I would respectfully suggest that we're not going to go much further than that on Blenrep today. Next question, please.

Luke Miels: Do you want to do the three?

Deborah Waterhouse: Oh, sorry, the three four. Yes. Tony, maybe Luke would be good because I know you.

70% think it's more compelling than competitors and 87% of patients, they cited early prefer it if the HTTP would recommend it. Um, we've done other forms of market research again, 86% of acps, think it will be standard of care and 82% would consider prescribing it. And that's before the launch, right? I mean, we don't have a bill Force out there. This is, this is very, um, organic. Um, but the biopen is 27 right now in severe Aspen around 12% nasal pots. Um, and I've, I've provided this before, but if you look at biologics, at the end of 12 months, you've lost about 65% of those patients. Um, so, you know, a combination of in-office administration, lower frequency of of it Administration, a validated known Target, excellent, uh, benefit risk profile. You know, I think it's going to be very exciting. Uh, We've also shown historically with Trilogy that we can Target the competition without disrupting our own business to extensively. So the hierarchy will be due picks and first

Luke Miels: Do you want to cover why you like the profile and I can say why we like the profile? I'll start with why I like the collaboration for start because the 500 million is also dedicated towards options for the other 11 innovative potential medicines that we have covering our INI and oncology. Let me just describe the profile of the molecule itself. I would describe it in terms of its PD34 balance as being similar to Verona. That's important because it means that we can be confident in the efficacy and safety profile of the molecule. Whilst it's similar in balance, it's about twofold more potent across that and has demonstrated both clinically and preclinically both bronchodilation and anti-inflammatory effects. That reduction in dose is important when one considers the optionality for a DPI.

Um, and then for Stendra, um, which makes sense, and the incentive scheme in the organization obviously will drive that, and there'll be limited points for switching your car up. So, um, yeah, very exciting there. Um, if I go to Shingrix, um, so continuation of XUS trend. I mean, yeah, if you look at what's going on there, um, I mean,

We like to do what we say we're going to do. And I think this is, um, an example of that. It's not apples to apples, but, um, because the US has a much broader coverage, you know you've got coverage from 50 years plus versus EU markets in Japan and others, which have a higher age cut-off. Even within countries and provinces, that can vary quite a bit. But, you know, the US is the steady client still. We've got 42%. So it's in line with what we've said: 3 to 5% penetration a year. Um, Germany, we're about 26%.

Luke Miels: And as Emma said, we have an extensive experience there based on our own DPI portfolio. And I'm looking forward to developing that molecule in partnership. And we see potential really across the gold framework as an add-on therapy. Luke, you want to add a bit more?

James Gordon: Yeah, I mean, we've obviously looked at this class for a while, for a couple of years now. We like it. I think the initial uptake is pretty clear. I think about 50% of the use is in very severe patients on top of standard of care triple, et cetera. But I think there will be a threshold where nebulization and the price starts to retard, letter hypothesis anyway, starts to retard things. So an alternative, you know, classical delivery approach, which is very synergistic with the rest of the portfolio, is exciting. And then the final thing I'd say is it's a good sign for COPD and Nucala and COPD because clearly there's an appetite for new mechanisms in particularly the more severe COPD population.

Uh, we had a bit of a soft, uh, August last year and we did a lot of work there, but we've figured out, uh, what happened there. And we're now back on a good growth trajectory using a strategy that we're now employing in the U.S. and Japan. This was based on the success we had in Australia where we're approaching 40% penetration, uh, in that market. And that was really targeting Cobalt with patients promoting directly to specialists, uh, like cardiologists and allergists, uh, rather than just a broad approach. If you look, you know, structurally, typically, if um, if you've got heavy funding, full funding, you've got penetrations, which are changing and growing between, you know,

Deborah Waterhouse: Yeah, I mean, and we're really pleased with the agility, in fact, the aggression we've been showing on partnering for BD out of assets out of China, whether it's the ADC deal we did or the long-acting T-slip or now adding this. And of course, you know, some great science. We all know what's happening in the biotech industry there, but then we can pick up partnering and then rolling through on international or global ex-China clinical network. And of course, manufacturing if that's successful. Next question, please.

You know, 8% and 29%, not including the US, and growing. If there's limited funding like in the UK, Spain, Italy, and China, then you've got a penetration range of around 4% to 8%, but also growing. And there is the opportunity, of course, to change that, as we've seen in Japan. So Japan had limited funding; it's now got much broader funding, and actually, it's a key driver for Shingrix, over and above France. And then, if it's out of pocket, you've got a penetration range of 3% to 4%. So, something to keep in mind for emerging markets. So, um, yeah, I...

Questions come from Carrie Hallford. From Baron Berry, please go ahead.

Thank you for taking my question. Um, just maybe a broader view.

Constantin Fest: The next question comes from Michael Leuchten from Jefferies. Please go ahead, Michael.

Question here. Um, any commentary you can give us more broadly on the discussions you’ve been having with the U.S. Administration on tariffs?

Speaker 9: Thank you for taking my questions. Two, please. One for Julie and one for Luke. Julie, your talk to the supply chain costs hitting COX in the second quarter, and then your slides say you expect the cross margin to benefit from product mix, but it doesn't say the cross margin is going to go up. Can you just clarify what those costs might mean for the second half, are they relevant or not? And a question for Luke. Nucala COPD, you've got 500 million peak sales on the slide now. I saw it in the past you talked to 502 billion. I might be wrong, but have your expectations come down for that relative to previous communication? Thank you.

But also in the context of MFN, um, how have those discussions evolved, and how do you think the administration intends to balance?

Those 2 items.

Introducing the tariffs officer and balancing that with the proposed plans to lower drug prices.

In the US, any direction or commentary he would be prepared to make at this point would be very helpful. And then, secondly, also on this. Um, the focus here in the US, the Trump Administration has indicated...

Deborah Waterhouse: Oh, definitely not. I'll say before Luke answers your question. And Julie, do you want to pick up gross margin? Recognizing remember that we have included in our guidance not only those enacted but those indicated in terms of Paris. So as that settles out with a bit more details to come, you know, we'll have more specificity. But Julie, do you want to pick up on gross margin and then Luke?

Reports for TTC cash, pay options for US patients.

Clearly, this is being utilized with obesity today in the DTC routes.

To Market.

I believe that you would consider in the US and if so, which drugs

Within your portfolio might best fit that approach. Thank you.

Julie Brown: Yeah, sure. Thank you very much for the question. So in terms of gross margin, we do anticipate some accretion this year. As you know, we took a charge for supply chain efficiencies in Q4 of last year of 150 million. So we will be comping that coming up in the fourth quarter. But nevertheless, the big point is that the specialty growth, which is very considerable, is driving an improvement in our gross margin. If all else was equal, you would see that coming through. What you see is causing some turbulence in the gross margin as one supply chain optimization charges are going through. And then the second one, as Emma just alluded to, is tariffs. Obviously, we haven't had any tariffs in the first half. We are anticipating some coming in the second half, and that will lower the gross margin slightly.

Thanks. So, um,

Look first, in terms of tariffs, um,

As you said, we've included in our outlooks, not only those that are enacted but those indicated. But it is important to reiterate that we're waiting on the 232 uh, investigation and the sort of specifics of that uh still need to uh, become clearer. I think it would be fair to say that. Uh,

Julie Brown: But even with the ones that have either been announced or indicated, we still see the opportunity for gross margin accretion coming through next.

Deborah Waterhouse: Right, thanks. Luke, you did.

Luke Miels: Yeah, thanks, Michael. I think 500 is fair, but of course, we are going to aim above that. If I look at initial signs, we're already ahead of where Dupixent was at the standpoint in its launch with new patient staff. So that's a good sign. I mean, the lead indicators are positive. So physicians clearly like the reduction in hospitalization and ED department visits, and that certainly resonates with them. We're also, interestingly, winning in terms of the perception in the lower EOS patient as well, which is sort of naturally historically Dupe's hunting ground, which is encouraging. And if you look at the market research, you've got, again, early days, but 67% of pulmonologists said they're likely to prescribe Nucala in COPD and prefer it versus only 30% with Dupixent. And you know, really good execution so far.

You know, you always have to separate from the headlines to the reality of what's delivered. And, um, you know, whilst on the 1 hand, we're now seeing numbers and indications that perhaps are not as, uh, higher than the first run of this. On the other hand, it is very, very real in terms of focused on uh us uh manufacturing and sourcing. Now, the really good news for GSK as I said, uh, uh, last quarter is we are well positioned on this. It's, you know, uh,

Since I started in this job, we prioritized together as a leadership team in the U.S. We've taken the business from being less than 40% to being more than 50%.

Luke Miels: We've seen 91% of our key customers with a really good frequency. So bang on there. I think balancing that back to your question is, you know, pulmonologists historically have not been as aggressive as maybe the evidence would support in terms of biologic penetration. So once we get more robust numbers, which will be, you know, IQV, the lag indicators, we'll have a better picture, but I think it's a good start. And we'll give you a fuller update in Q3 when we've got data, which of course is, you know, what counts you know, quantum overall.

The pipeline's focused and the Innovations focus on the growth focus is 2/3 of that so far this year, is in the US. So, so, we're well positioned for that. We're well, positioned on the manufacturing, we broke ground on another new battery, some of the supply chain optimizations dually referred to is also setting up some, you know, um, certain shifts of, some of our, uh, production so that we'll continue to be uh, agile, uh, around it. But I I I, you know, whilst we rather spend any incremental costs more on the pipeline. And as you know, we prioritize uh, spending on R&D and we're pleased to be increasing that ahead of Topline again. Uh this year um you know uh we we think we're, you know positioned well to find Solutions as this evolves on MF.

you know, um,

Alongside others. Yes we're in. Um discussions. Yes we uh really want to prioritize keeping the us as the best market for Innovation and also

Deborah Waterhouse: And you know, the only other thing I'd say on this one is what we're aiming to do is be, you know, indisputable leaders in COPD medicines. That is the strategy that Tony has laid out with a comprehensive portfolio that we've added to to be able to subsegment and treat this enormous burden of disease. You know, more than 300 million people, third leading cause of death, 70%, as Luke said, of the costs related to COPD are hospitalization. Nucala is the only medicine with a demonstrated 35% reduction in hospitalization. Tony confirmed the start of the DEPI COPD trial. So one of the things that might contain over time the PTSLs of Nucala is bringing a six-monthly IL-5 to COPD. And then, of course, we've got the long act. We've got the whole portfolio of assets that we've already started talking about. So exciting start.

To deploy access to Innovation and to make sure that we're passing on discounts given to patients, so that medicines are sustainably, uh, affordable. We also would like to see more countries investing in mentions, which is such a small fraction of the total cost of healthcare. And that's why our pipeline is really important here, because so many of the examples, we've talked to you about are cost sparing, whether it is COPD or frankly, the fact that Ben rep can be Community administered rather than um, you know, long stays in in in hospital whether it is the adherence of Deputy with that over 70% reduction, um or of course the best way to stop disease before it starts being vaccination. So uh you know, we continue to have that dialogue. Um, and you know we will update you alongside others. No. Doubt as it becomes clearer and and yes, I do think they are all inter late. Um,

Alongside trade uh, discussions and on DTC. That's definitely part of the things we're building. I can see. But maybe I'll ask Luke to comment on how we see some differences in the port portfolio around that. Yeah, um, yeah, thanks Carrie. I mean, I think the first thing

Deborah Waterhouse: I think we've confirmed and reiterated at half a billion for this one, but let's see how it goes. Next question, please.

Constantin Fest: Next question comes from Setchin Jane on Bank of America. Setchin, please go ahead.

Speaker 9: I think my question's I got two or three product ones, please. So firstly, on the same vein on DEPI, Luke, I wonder if you just give us a better sense of launch. So is there anything about market expansion, Nucala cannibalization switches from competition? And I guess specifically consensus is only 200 million for next year, which seems conservative regardless of the launch you potentially describe. Secondly, on Shingrix, I wonder if you could talk about continuation of the XUS trends and how much of those European launches are potentially bonuses versus continuing. And thirdly, I will apologize, but I will try my arm once on Blenrep. Just want to understand why the data you've submitted, you wouldn't have used as part of the ADCOM debate if it was material enough to shift the debate you knew was coming. Thank you.

Um, their own program, their insurance program. Um, and then, secondly, I mean, there are some products, like Blue, Jeopardy, that could be amendable to that. We're looking more broadly at products like Trilogy. Uh, and we've got an open mind. There's clearly an opportunity in certain sub-patient segments. We've seen that, as you mentioned, with the LP1s, but I think it's very much, as Emma said, a watching brief at this point. But we can move very quickly once things settle out and we know what the rules are.

Thank you. Thanks question, please.

Next question comes from Matthew Weston from UBS Matthew, please go ahead.

Thank you. Hopefully, you can hear me uh, 1 quick, comment, and then 2 questions. If I can, the quick comment is just to actually say Michael's, right? The GSK respiratory investor Deep. Dive event new Carlos. COPD psls was 500 to 1 billion, but anyway, we take your comments.

Deborah Waterhouse: Sorry, I didn't. It wasn't on purpose, but I didn't actually hear the third question on Blenrep. Could you repeat it?

2 product questions. If I can click since um, Tony the car 1 program does seem to be rolling back in terms of timeline now. Second half of 26.

Speaker 9: Why data that you've submitted, you wouldn't have used as part of the ADCOM debate if it's material enough to shift the FDA's view on a debate that you knew was coming, given you get the briefing documents well ahead of the actual ADCOM? Thanks.

If we've got such unmet need in chronic cough. Clear efficacy what's holding patients and Physicians back from signing up to the trial or are we wrong? We just had the timing too early and then secondly, I am going to chance my arm Blain wrap

Deborah Waterhouse: Yeah, I'm we're not going to comment on that. So good try. But Luke, would you like to answer the first two questions on ambitions around DEPI and Shingrix? Thanks.

Go for it. It's just on the study design of the existing studies, which are still ongoing.

Luke Miels: And welcome back, Set. Yeah, look, I think on DEPI, you know, a lot of excitement. I think for anyone that's attended an academic meeting where the data has been presented, I think there's a lot of enthusiasm here, and I'll quote some numbers for the market research. Inside, of course, the track record of this team for Nucala and execution for START is very good. There's a high excitement there. I think with physicians, there's also high anticipation. You know, we've got really robust data here in controlled studies, and I think most people can see that efficacy, but also have the imagination to understand in the real environment with less supervision that data hopefully should improve, and we've got a program to capture that. Look, I won't go into the strategy and positioning, but you know, the testing response is really clear.

Have you decided to change any, protocols recruit more us? Patience or optimize anything in light of what you heard at the Adcom.

so I'm not sure there is going to be

Luke Miels: When we've taken that profile and that strategy to pulmonologists and allergists, 94% of them are motivated to prescribe the product. 70% think it's more compelling than competitors, and 87% of patients, as I cited earlier, prefer it if the HCP would recommend it. We've done other forms of market research. Again, 86% of HCPs think it will be standard of care, and 82% would consider prescribing it. And that's before the launch, right? I mean, we don't have a blood loss out there. This is very organic. The biopin is 27 right now in severe asthma, around 12% nasal polyps. And I've quoted this before, but if you look at biologics, at the end of 12 months, you've lost about 65% of those patients.

You can answer on how many I will just say there is no change to the level of ambition on the new Call of COPD. But um, uh Tony. Do you want to comment on the other just simply in General, on recruitment in forward-looking on oncology studies where we have. We're enacting extensive plans to ensure that we have greater us representation going forward. Um, in in the case of the studies we have conducted they were not a typical with some representation in myeloma studies and we were careful to ensure that the outcomes and demographics we thought were consistent in European patients. But more importantly going forward. We we have a a, an extensive focus on us representation. Then just since you mind, if I just run straight into canola pixel. Yeah, I think it's worth clarifying.

Luke Miels: So you know, a combination of in-office administration, lower frequency of administration, a validated non-target, excellent benefit-risk profile, you know, I think it's going to be very exciting. We've also shown historically with Trelegy that we can target the competition without disrupting our own business too extensively. So the hierarchy will be Dupixent first and then Fasenra, which makes sense. And the incentive scheme in the organization obviously will drive that, and there'll be limited points for switching Nucala. So yeah, very exciting there. If I go to Shingrix, so continuation of XUS trend. I mean, yeah, if you look at what's going on there, I mean, we like to do what we say we're going to do, and I think this is an example of that.

Yeah, and and look. Um, so first of all, there's nothing. Um proving Difficult about the kind of picks and studies. We um, you will remember, um, earlier I identified that in column 2, we've been given the opportunity to add a larger proportion of higher frequency, coffers into the study that that is the group for which we feel the pharmacology is more likely to be, um, representative. And in addition, you'll also recall that because of the difficulties of lurking, counted as a design Recruitment and other features of the study, we are taking careful action.

Luke Miels: It's not apples to apples, but because the US has a much broader coverage, you know, you've got coverage from 50 years plus versus EU markets and Japan and others, where they have a higher age cutoff. And even within countries and provinces, that can vary quite a bit. But you know, the US is a steady client still. We've got 42%, so a thin line of what we've said, 3% to 5% penetration a year. Germany, we're about 26%. We had a bit of a soft August last year, and a lot of work there, but we've worked out what happened there, and we're now back on a good growth trajectory using a strategy that we're now employing in the US and Japan. And this was based on the success we had in Australia, where we're approaching 40% penetration in that market.

To ensure that we have a we have covered all of that both in terms of pre-screening um and and other features associated with. For example, the Cog counter, as I said, count to is proceeding on track as we planned. We are recruiting into the study right now. It is a 6-month completion when we are closer to full, um, recruitment into that. I will know more about the precise date, but we are on track for um, middle of next year. And as um, I said to Simon we will as we typically do with our phase 3 studies. So we where we have 2 studies on going combine both results into the analysis before the submission. So there is nothing behind that. In terms of, um, any difficulties associated with the study other than um, the plan that we've already described.

Which is ensuring that what we see as being the unique profile that can the pixcent offers both in terms of its efficacy. And I'll remind you in the suit study, we saw 34% reduction in cough frequency relative to Placebo and in terms of its selectivity profile which in simple terms is about 10 times better than jeffa pixon and is therefore likely to result in fewer um dropouts and will certainly not unblind the study.

Right next question, please. Next question comes from adult from being paid by about Peter. Please, go ahead.

Luke Miels: And that was really targeting comorbid patients, promoting directly to specialists like cardiologists, allergists, rather than just a broad approach. If you look, you know, structurally, typically, if you've got heavy funding, full funding, you've got penetrations, which are changing and growing between, you know, 8% and 29%, not including the US, and growing. If there's limited funding like the UK, Spain, Italy, China, then you've got a penetration range of around 4% to 8%, but also growing. And there is the opportunity, of course, to change that, as we've seen in Japan. So Japan had limited funding. It's now got much broader funding, and actually, it's a key driver for Shingrix over and above France. And then if it's out of pocket, you've got penetration range of 3% to 4%. So something to keep in mind for emerging markets. So yeah, I think there's remaining potential outside the US.

I will respect that, but it's a factual question. Am I correct in that assumption that there are no U.S. sites currently for June 10th? And then secondly, on the Hangry deal, after PD 34, is there any other asset you can call out at this stage that might be entering the clinic in the next 12 to 18 months, or do we need to be a little more patient? Thank you.

Luke Miels: We're still very focused on the US, but hopefully, there's numbers at a health course session and answered your question.

Deborah Waterhouse: Brilliant. Thanks. Next question, please.

Constantin Fest: Next question comes from Carrie Hallford from Berenberg. Carrie, please go ahead.Thank

Tony Wood: you for taking my questions. Just maybe a broader US question here. Any commentary you can give us more broadly on the discussions you've been having with the US administration on tariffs, but also in the context of MFN? How have those discussions evolved, and how do you think the administration intends to balance those two items, introducing tariffs, offset, and balancing that with the proposed plans to lower drug prices in the US? Any directional commentary you would be prepared to make at this point would be very helpful. And then secondly, also on this, on the focus here in the US, the Trump administration has indicated support for DTC, cash pay options, for US patients. Many of this is being utilized with obesity today. Is the DTC route to market a route that you would consider in the US?

Yeah, let me just quickly deal with June 10th. You're right on clean. Trials.gov doesn't show our our activities to recruit us patience at this current point of time. But as I said, we have extensive studies that we're enacting, that will increase us. Um, patient recruitment, um, not just for June 10th, but more broadly across the portfolio, including the new adc's. Um, and then sorry. Secondly, remind me of the second question. Um, yeah, look, um, we we in in, in signing the deal, we contemplated the first

Um, there are 4 or 5 potential options, but I'm not going to disclose those in any more detail at this stage. The key is that...

all therapy areas for for expansion for us and we'll keep you updated as we roll those through. And some of them will definitely be in the clinic next year. Definitely.

Next question comes from Rajan Sharma from botland X. Rajan, please go ahead.

Tony Wood: And if so, which drugs within your portfolio might best fit that approach? Thank you.

Hi. Um, thanks for taking my questions. Um, so just wanted to get an update on Blue Jeep has launched. Um, so I think it was approved back in March, but it doesn't look like it's launched yet, so it'll be helpful to just understand timelines there. And then expectations in terms of the launch trajectory, given that you've I think previously guided to more than $2 billion peak sales for that new anti-infective portfolio. Um, and then mostly based on the commentary, it looks like R&D expenses will be higher than previous guidance. Um, could you just help us understand what the drivers are? It doesn't look like there's any kind of materially large neutrals that are, uh, picking off in the second half of the year or maybe a couple rolling off. Um, so that would be helpful there. Thank you.

Emma Walmsley: Yeah, thanks. So look, first, in terms of tariffs, as you said, we've included in our outlooks not only those that are enacted but those indicated. But it is important to reiterate that we're waiting on the Q3/Q2 investigation, and the sort of specifics of that still need to become clearer. I think it would be fair to say that you know, you always have to separate from the headlines to the reality of what's delivered. And you know, whilst on the one hand, we're now seeing numbers and indications that perhaps are not as high as in the first run of this, on the other hand, it is very, very real in terms of focus on US manufacturing and sourcing. Now, the really good news for GSK, as I said last quarter, is we are well positioned on this.

Yeah, I was doing maybe 1 next, we do have 4 big ones.

Off second half and then Luke, I mean that we'll comment on Blue. Jeff we did say at last quarter that um because of formerly Rhett timing, we're, you know, going to be a bit later with that launch and it is a full portfolio of anti-infectives but when we're very ambitious for a long time since anyone brought in a new antibiotics. But so Julie first and then Luke, please.

Emma Walmsley: Since I started in this job, we prioritized together as a leadership team the US. We've taken the business from being less than 40% to being more than 50% of the company now. And in fact, our specialty business, which is where the pipeline's focused and the innovation's focused and the growth's focused, is two-thirds of that so far this year is in the US. So we're well positioned for that. We're well positioned on manufacturing. We broke ground on another new battery. Some of the supply chain optimizations Julie referred to are also setting up some, you know, certain shifts of some of our production. So look, we'll continue to be agile around it.

Yeah, thank you. So, um, the main R&D areas, we we sat down as a team and looked at the areas we wanted to accelerate. Um, and clearly 1 of the main areas is the ADC portfolio, I think is Tony's covered. We've got a large number of solid tumor opportunities with B7 H3, which we are looking into to accelerate considerably this year, and into next year. And then as Emma mentioned, we've got 4 pivot tools. Now, going through, um, 3 of which are BD orientated or sourced and 1 is our own. So those are the main areas. Tony do you want to answer that? No that's completely. It's it's it's 4. New phase 3 studies in the ADC portfolio expansion, right? Look, yeah, thanks Rajan. So as Emma said we're talking to payers right now. Um, things should be more visible in Q3 with a full launch. Push in q1 next year. If you just look at Patients, uh, there's around 15 million episodes of uncomplicated UTI in the US with 3 million. Um, our individuals that are resisting to multiple

Emma Walmsley: But I, you know, whilst we'd rather spend any incremental costs more on the pipeline, and as you know, we prioritize spending on R&D, and we're pleased to be increasing that ahead of top line again this year. You know, we think we're positioned on finding solutions as this evolves. On MFN, still very much, you know, moving around. But I think alongside others, yes, we're in discussions. Yes, we really want to prioritize keeping the US as the best market for innovation and also to deploy access to innovation and to make sure that we're passing on discounts given to patients so that our medicines are sustainably affordable. We also would like to see more countries investing in medicines, which is such a small fraction of the total cost of healthcare.

Classes or allergic to to 3 or more antibiotics. That's the targeting population. We've got there, we just wanted to do a little bit more work on the pricing. Um, and also with head positive phase 3 results with Deb pain and which I think is also very attractive. Um, initially in, in complicated, UTI patients, you typically are admitted, uh, for Cryin treatment. So, this is the option of keeping those patients off the path to them at home, uh, with you know, patient benefits as well as cost benefits in the US Health Care system.

System. Yeah. And and another 12 stop for efficacy there so excited to see what comes on today. Next question, please.

The next question comes from.

Emma Walmsley: And that's why our pipeline is really important here because so many of the examples we've talked to you about are cost-sparing, whether it is COPD or, frankly, the fact that Blenrect can be community-administered rather than, you know, long stays in hospital, whether it is the adherence of Deti with that over 70% reduction or, of course, the best way to stop disease before it starts being vaccinations. So, you know, we continue to have that dialogue, and you know, we will update you alongside others, no doubt, as it becomes clearer. And yes, I do think they are all interlinked alongside trade discussions. And on DTC, that's definitely part of the things we're building up into. But maybe I'll ask Luke to comment on how we see some differences in the portfolio around that.

GSK expect data readout for the 24 in infants and then lastly apologies. Blenrep does the recent FDA saber leadership change. Alter the Outlook in any way. The proximity of the news is quite curious. Thank you.

Julie Brown: Yeah. Yeah, thanks, Kerry. I mean, I think the first thing is the price has to be low and that someone can get it through their own program, their own insurance program. And then secondly, I mean, there are some products like Blue Jet that could be amenable to that. We're looking more broadly at products like Trilogy. And we've got an open mind. There's clearly an opportunity in certain subpatient segments. We've seen that, as you mentioned, with the OpiOnes. But I think it's very much, as Emma said, a watching brief at this point. But we can move very quickly once things settle out and we know what the rules are.

In China and then, uh, Tony or an update on uncool overall. Um, thanks, Steve. Uh, look, Andrew, look, it's still challenging for all the reasons we explained in Q3 of 2024. However, there are some small, they're very small, um, green shoots. So if you look at in-market sales, CDC, so the market sells to CDC from GFA.

Tony Wood: Thank you. Next question, please.

Constantin Fest: Next question comes from Matthew Weston from UBS. Matthew, please go ahead.

Deborah Waterhouse: Thank you. Hopefully, you can hear me. One quick comment and then two questions if I can. The quick comment is just to actually say Michael's right. The GSK respiratory investor deep dive event, new carless COPD PES sales was 500 to 1 billion. But anyway, we take your comments. Two product questions if I can. Pamela Dixon. Tony, the Calm One program does seem to be rolling back in terms of timeline now second half of '26. If we've got such unmet need in chronic cough, clear efficacy, what's holding patients and physicians back from signing up for the trial? Or are we wrong? We just had the timing too early. And then secondly, I am going to chance my arm. Blenrecht.

And the movement from CDC to the point of vaccinations. There is a trend upwards for the last. Um, yeah, it's 3 months for memory. Um, but it's often very low base so you know, heavy caution there. Um, the other thing is the CDC, stock levels are declining and they've been declining since about February of this year. Um, so it's not enough to, to, for us to trigger a major shipment to ship a but it is, you know, it's it's at least pointing in the right direction. Um, the other point I'd make is, look this, you know, we've done a lot of work on the strategy on the way forwards here, it's very clear and we've got good alignment with shifting and it's the, the focus on the code morbid. Chronic disease subpopulation, um, who are clearly high risk, which

Emma Walmsley: Go for it.

Deborah Waterhouse: It's just on study design of the existing studies which are still ongoing. Have you decided to change any protocols, recruit more US patients, or optimize anything in light of what you heard at the ADCOM?

Get that attraction there. Um the competition's pulled back uh which is great A Bit of room for us and we've actually increased our share of voice to take advantage of that. Um all the other parameters like ATB perception, patient perception are pretty stable. Um, so again, you know, I I won't say anything about 26 but I would say we remain confident that their needs to longer term opportunity in China. And we just need to stick at it. Um and uh finally we're also doing some life cycle Tony mentioned this before, in terms of a dementia experience in within China itself. So um, yeah, we'll keep moving forwards.

Emma Walmsley: So I'm not sure there is going to be much to add on Blenrecht for the reasons we've said. But Tony, if you want to add anything at all, please go ahead. And then perhaps you can answer on Calm. I will just say there is no change to the level of ambition on the new carless COPD. But Tony, do you want to comment on that?

Julie Brown: Yeah, just simply in general on recruitment and forward-looking on oncology studies where we are, we're enacting extensive plans to ensure that we have greater US representation going forward. In the case of the studies we have conducted, they were not atypical with representation in myeloma studies, and we were careful to ensure that the outcomes and demographics we felt were consistent in European patients. But more importantly, going forward, we have an extensive focus on US representation. Then just, do you mind if I just run straight into Pamela Dixon's talk?

Great. And then just quickly on that last to Steve, um, as far as 24 valence, um, platforms are concerned both in adults and infants, we've learned enough from those platforms to move. Now to strategically, prioritize the 30 plus vaccine. We feel that the characteristics of the maps platform are better, expressed there. And I'm, I'm sure you'll follow that. The field in general is going in that direction and and looks sort of a more tailored approach is also encountering some issues associated with, um, with concerns, with regards to the evolution of new serotypes, like, serotype, 4, we are um, on track with regards to starting our first in human for a 30 plus vaccine study at the end of this year. So you should expect readouts on that, really in the, the, um, first off of 2026. Um, I'd say when you consider the progress we're making with regards,

Emma Walmsley: Yeah, I think it's worth clarity.

Julie Brown: Yeah. And look, so first of all, there's nothing proving difficult about the Pamela Dixon studies. You will remember earlier I identified that in Calm II, we've been given the opportunity to add a larger proportion of higher-frequency coughers into the study. That is the group for which we feel the pharmacology is more likely to be representative. And in addition, you'll also recall that because of the difficulties that Luke encountered in the design, recruitment, and other features of the study, we are taking careful action to ensure that we have covered all of that, both in terms of prescreening and other features associated with, for example, the cough counter. As I said, Calm II is proceeding on track as we planned. We are recruiting into the study right now. It is a six-month completion.

To the 30 plus format and the competitive environment. We remain very much on track and competitive with the 30 plus vaccine. But that, of course, will be towards the end of the decade, right? Thank you. I think we have 1 more question. Yes. 10 for 1, last short questions, um, Justin Smith these um from Bernstein, please go ahead.

I think you should be able to speak, Justin.

Julie Brown: When we get closer to full recruitment into that, I will know more about the precise date, but we are on track for the middle of next year. And as I said to Simon, we will, as we typically do with our phase three studies, where we have two studies ongoing, combine both results into the analysis before the submission. So there is nothing behind that in terms of any difficulties associated with the study other than the plan that we've already described, which is ensuring that what we see as being the unique profile that Pamela Dixon offers, both in terms of its efficacy.

Okay, that's not working. Then we can also close the call and I will. Okay. Well listen, thanks very much. Everyone for joining uh, delighted to be reporting another strong border and this consists of delivery of the consistent Step Up of GSK uh since the separation and most excitingly. The R&D progress, we can continue uh, to deliver, uh, we're pleased to update our guidance for the year to being at the top end of the range, and continue to be highly confident together of

No, not only are shorts but our medium and our long-term outlooks look forward to talking to you over the coming days. Thanks.

Julie Brown: And I'll remind you, in the SUIT study, we saw a 34% reduction in cough frequency relative to placebo and in terms of its selectivity profile, which in simple terms is about 10 times better than Jeff McLaughlin's and is therefore likely to result in fewer dropouts and will certainly not unblind the study.

Tony Wood: Right. Next question, please.

Constantin Fest: Next question comes from Peter Baddalt from BNP Paribas. Peter, please go ahead.

Deborah Waterhouse: Yeah, thanks, Constantine. Peter Baddalt BNP. Just two quick ones for you, Tony. Just following up from Matt's, I hear your comments about adequate US trial representation in your key programs. But just a factual question. When we checked the DREAM10 first-line study, there are no US sites. Now, I know we can't talk about Blenrecht. I will respect that. But it's a factual question. Am I correct in that assumption that there are no US sites currently for DREAM10? And then secondly, on the HANGRY deal, after PDE34, is there any other assets you can call out at this stage that might be entering the clinic in the next 12 to 18 months? Or do we need to be a little more patient? Thank you.

Julie Brown: Yeah, let me just quickly deal with DREAM10. You're right. On claimtrials.gov, it doesn't show that our activities to recruit US patients at this current point in time. But as I said, we have extensive studies that we're enacting that will increase US patient recruitment, not just for DREAM10 but more broadly across the portfolio, including the new ADCs. And then, sorry, secondly, remind me of the second question.

Constantin Fest: Hang for a minute.

Julie Brown: Hang for a minute. Yeah, look, in signing the deal, we contemplated the first four or five of potential options there. But I'm not going to disclose those in any more detail at this stage.

Emma Walmsley: The key is they're all in areas that are core to, you know, core therapy areas for expansion for us. And we'll keep you updated as we roll those through.

Julie Brown: And some of them would then be in the clinic next year.

Emma Walmsley: Definitely.

Constantin Fest: Next question comes from Rajan Sharma from Dotmazax. Rajan, please go ahead.

Simon Baker: Hi. Thanks for taking my questions. So I just wanted to get an update on Blue Jetter's launch. So I think it was approved back in March, but it doesn't look like it's launched yet. So it'd be helpful to just understand timelines there and then expectations in terms of the launch trajectory, given that you've, I think, previously guided to more than 2 billion peak sales for that new anti-infective portfolio. And then, obviously, based on the commentary, it looks like R&D expenses will be higher than previous guidance. Could you just help us understand what the drivers are? It doesn't look like there's any kind of materially large new trials that are kicking off in the second half of the year and maybe a couple are rolling off. So that would be helpful there. Thank you.

Emma Walmsley: Yeah, I was really thinking we'll do that. So we think that's four big ones, big pivotals kicking off second half. And then Luke, I mean, we'll comment on Blue Jet. We did say last quarter that because of formulary timing, we're going to be a bit later with that launch. And it is a full portfolio of anti-infections, but one we're very ambitious for. A long time since anyone brought any new antibiotics. But so, Julie, first, and then Luke, please.

Luke Miels: Yeah, thank you. So the main R&D areas, we sat down as a team and looked at the areas we wanted to accelerate. And clearly, one of the main areas is the ADC portfolio, I think, as Tony's covered. We've got a large number of solid tumor opportunities with B783, which we are looking into to accelerate considerably this year and into next year. And then, as Emma mentioned, we've got four pivotals now going through, three of which are BD-orientated or sourced, and one is on our own. So those are the main areas. Tony, do you want to add to that?

Julie Brown: No, that's complete. It's four new phase three studies in the ADC portfolio expansion.

Emma Walmsley: Thanks. Luke?

Julie Brown: Yeah, thanks, Rajan. So as Emma said, we're in the pairs right now. Things should be more visible in Q3 with a full launch push in Q1 next year. If you just look at patients, there's around 15 million episodes of uncomplicated UTIs in the US, of which 3 million are individuals that are resistant to multiple classes or allergic to three or more antibiotics. That's the targeting population that we've got there. We just wanted to do a little bit more work on the pricing. And although we've had positive phase three results with Evipenem, which I think is also very attractive, initially in complicated UTI patients, we typically are admitted for ceftriaxone treatment. So this is the option of keeping those patients on the pump, keeping them at home with patient benefits as well as cost benefits in the US healthcare system.

Emma Walmsley: Yeah, and it's another 12-step for efficacy there. So excited to see what comes on the telly. Next question, please.

Constantin Fest: The next question comes from Steve Scala from TD Cohen. Go ahead, Steve, please.

James Gordon: Thank you so much. A few questions. First, I'm curious about trends of Shingrix in China through the distributor. Are things improving, getting worse, or somewhere in between? Yesterday, Merck implied that there were no signs of improvement for Gardasil and issues could extend to 2026. Is the same true for Shingrix? Secondly, can we have an update on the pneumococcal vaccine program? Will you initiate phase three in the 30-valent vaccine in adults? When do you intend to do that? Secondly, have you addressed the manufacturing issues for the pediatric vaccine? And when does GSK expect data readout for the 24-valent in infants? And then lastly, apologies, Blenrecht. Does the recent FDA CBER leadership change alter the outlook in any way? The proximity of the news is quite curious. Thank you.

Emma Walmsley: So on the last one, there's no read across from that. And let's go to Luke, please, first on Shingrix in China. And then Tony on an update on pneumococcal overall.

Julie Brown: Thanks, Steve. Look, look, it's still challenging for all the reasons we explained in quarter three of 2024. However, there are some small, they're very small, green shoots. So if you look at in-market sales CDC, so market sales to CDC from GFA and the movement from CDC to the point of vaccination, there is a trend upwards for the last, yeah, it's three months for memory. But it's often very low base, so a heavy portion there. The other thing is the CDC stock levels are declining, and they've been declining since about February of this year. So it's not enough for us to trigger a major shipment to GFA, but it is, you know, it's at least pointing in the right direction. The other point I'd make, we've done a lot of work on the strategy and on the way forwards here.

Julie Brown: It's very clear, and we've got good alignment with GFA. And it's the focus on the comorbid chronic disease subpopulation who are clearly high risk. We seem to get better traction there. The competition's pulled back, which has created a bit of room for us. And we've actually increased our share of voice to take advantage of that. All the other parameters like ATP perception, patient perception are pretty stable. So again, you know, I won't say anything about '26, but I would say we remain confident of the mid to longer-term opportunity in China, and we just need to stick at it. And finally, we're also doing some lifecycle. Tony mentioned this before in terms of a dementia experiment within China itself. So yeah, we'll keep moving forwards. Great.

Julie Brown: And then just quickly on that, Steve, as far as the 24-valent platforms are concerned, both in adults and infants, we've learned enough from those platforms to move now to strategically prioritize the 30-plus vaccine. We feel that the characteristics of the MAPS platform are better expressed there. And I'm sure you'll follow that the field in general is going in that direction. And MAPS, so the more tailored approach, is also encountering some issues associated with concerns with regards to the evolution of new serotypes like serotype 4. We are on track with regards to starting our first in human for a 30-plus vaccine study at the end of this year. So you should expect readouts on that really in the first half of 2026.

Julie Brown: I'd say when you consider the progress we're making with regards to the 30-plus format and the competitive environment, we remain very much on track and competitive with the 30-plus vaccine. But that, of course, will be towards the end of the decade.

Emma Walmsley: Right. Thank you. I think we have one more question.

Constantin Fest: Yes. Time for one last short question. Justin Smith, please, from Bernstein. Please go ahead.

Emma Walmsley: Justin Smith.

Constantin Fest: Yeah. I think you should be able to speak, Justin.

Emma Walmsley: Okay.

Constantin Fest: If that's not working, then we can also close the call.

Emma Walmsley: Okay. Well, listen, thanks very much, everyone, for joining. Delighted to be reporting another strong quarter. And this delivery is a consistent step up from GSK since the separation. And most excitingly, the R&D progress we continue to deliver. We're pleased to update our guidance for the year to being at the top end of the range and continue to be highly confident together of not only our short but our medium and our long-term outlooks. Look forward to talking to you over the coming later.