GSK Q4 2025 GSK PLC Earnings Call | AllMind AI Earnings | AllMind AI
Q4 2025 GSK PLC Earnings Call
[music].
Okay.
Ladies and gentlemen, a warm welcome to the GSK full year 2025 results call.
Speaker #5: Empirico 012, and that's now called GSK 821. That's a long-acting oligo, which is aimed at a broad spectrum, as I indicated. We haven't disclosed the mechanism yet, but we will in the future as we gather more data.
I'm delighted to joined today by Luke miles minimal, yes, Deborah Waterhouse, Tony Wood and Julie Brown.
And in our G&A session, we will be joined by David Redfern.
Speaker #5: And James, what I will say is we're going to resist the temptation, as a company, to construct a lovely PowerPoint slide that shows how we'll carefully capture this bit and have trade-offs amongst our products.
Today's call will last approximately one hour with the presentation, taking around 30 minutes and the remaining time for your questions.
Ladies and gentlemen.
Please ask only one to two questions. So that everyone has a chance to participate.
Warm welcome to the GSK full year 2025 results call.
Speaker #5: I mean, there is strategic intent here, but we also recognize there's a Darwinian dimension here. In terms of the data that these targets generate, but also the competition gets a vote as well.
Before we start please turn to slide three.
I'm delighted to be joined today by Luke miles minimal, yes, Deborah Waterhouse, Tony Wood, and Julie Brown and.
Speaker #1: Ladies and gentlemen, a warm welcome to the GSK full year 2025 results call. I'm delighted to be joined today by Luke Miels, Nina Moyas, Deborah Waterhouse, Tony Wood, and Julie Brown.
This is the usual safe Harbor statement.
We will comment on our performance using constant exchange rates or CER, unless otherwise stated.
And then Archie ne session, we will be joined by David Redfern.
Speaker #5: I mean, ultimately, the long-acting is the future. The launch for new-collar COPD in the US is going very well. And I was just there on Monday.
Today's call will last approximately one hour with the presentation, taking around 30 minutes and the remaining time for your questions.
I will now hand over to Luke.
Thank you and welcome everyone. My introduction today will have two parts headline results for 2025, and our key focus areas in 2026 to drive value.
Speaker #1: And in our Q&A session, we will be joined by David Redfern. 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.
Speaker #5: We have around, well, depending on which data set, 43% to 46% of new patient starts already. The market research and the messaging is really resonating.
Before we start please turn to slide three.
<unk> with 2025 results with strong sales were up 7% to more than 32 billion pounds.
This is the usual safe Harbor statement.
Speaker #1: 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 CER, unless otherwise stated.
Speaker #5: But we have transferred all of our new collar reps to Collar COPD, it's Exscience. And new being promoted by the Trelegy legacy team. Because, again, we need to place our bets on the future.
Growth was driven by specialty medicines, which were up 17% with vaccines also contributing.
I'll now hand over to Luke.
Operating profit grew 11% and EPS was up 12%.
Speaker #1: We will comment on our performance using constant exchange rates, or CER, unless otherwise stated. I will now hand over.
Thank you and welcome everyone. My introduction today will have two parts headline results for 2025.
Cash generation was strong at $8 9 billion pounds supporting future investment and returns to shareholders.
And our key focus areas in 2026 to drive value.
Speaker #5: And the ultimate future with aisle 5 and higher EOS is going to be long-acting Extensure for COPD. So, thanks, James. Appreciate that question. Deborah,
Speaker #1: to Luke.
Speaker #2: Thank you and
Speaker #2: Welcome, everyone. My introduction today will have two parts: headline results for 2025, and our key focus areas in 2026 to drive value. Starting with 2025.
With 2025 results with strong sales were up 7% to more than 32 billion pounds.
Enabling the dividend upgrade of two to <unk> 66 pence declared today.
R&D output remained very positive with five FDA approvals and seven new pivotal trial stocks.
Speaker #5: Do you want to give an update? Thanks, Luke.
Growth was driven by specialty medicines, which were up 17% with vaccines also contributing co.
Speaker #2: So, the key thing that I want to re-emphasize is that we're on track to select our Q6M treatment regimen in the middle of the year.
And we maintained our high standards for being a responsible business.
Speaker #2: Results were up 7% to more than $32 billion. Growth was driven by specialty medicines, which were up 17%, with vaccines also contributing. Core operating profit grew 11%, and EPS was up 12%.
Core operating profit grew 11% and EPS was up 12%.
Looking forward, we expect another year of profitable growth reflected in the guidance given today. Thanks, a lot place.
Speaker #2: And as I said, we're going to do a meet-the-management event mid-year, where we'll lay out a lot more detail about the pipeline. But let me just give you a top-line view now.
Cash generation was strong at $8 9 billion pounds supporting future investment and returns to shareholders.
In 2026, we expect momentum to continue and we will get there by focusing on execution and operational delivery.
Enabling the dividend upgrade to paid to 66 tenths decline today.
Speaker #2: Cash generation was strong, at $8.9 billion, supporting future investment and returns to shareholders. Enabling the dividend upgrade of 2p to 66 pence, declared today.
Speaker #2: So let's start with treatment. The treatment market is $20 billion in value, 90% of the value of the total HIV market. As I said on my presentation, Q6M is clearly our biggest opportunity in treatment.
R&D output remained very positive with five FDA approvals and seven new pivotal trial stocks and we maintained our high standards to being a responsible business.
There are three areas, where we're focused the first is driving top line growth by maximizing launched products like <unk> and Accenture.
And insurance success in overall operational execution.
Speaker #2: R&D output remained FDA approvals and seven new pivotal trial starts. And we maintained our high standards for being a responsible business. Looking forward, we expect another year of profitable growth, reflected in the guidance given today.
Looking forward, we expect another year of profitable growth reflected in the guidance given today. Thanks, a lot placed.
Second accelerating key assets and our lifestyle portfolio like be 783, <unk> 94, and buildup nib in oncology and in mesh.
Speaker #2: We're very confident in the assets that we've got to choose from, and the COI dates that we'll present will show just how strong those assets are—particularly BH184, which is a unique, third-generation, really potent integrated inhibitor.
In 2026, we expect momentum to continue and we will get there by focusing on execution and operational delivery.
And in our earlier portfolio like the ultra long acting T slim for respiratory diseases and regimen selection, perhaps six monthly treatments for HIV and third continue to execute business development, where we see a clear path to value creation.
Speaker #2: Next slide, please. In 2026, we expect momentum to continue. And we'll get there by focusing on execution and operational delivery. There are three areas where we're focused.
There are three areas, where we're focused the first is driving top line growth by maximizing launch products like <unk> and Accenture and.
Speaker #2: And we believe that to have a really potent regimen, you need to have an integrated inhibitor at the core. So, in terms of what kind of when studies will start—Q6M treatment—you'll see us moving to phase 2b this year.
And ensuring success in overall operational execution.
Speaker #2: The first is driving top-line growth by maximizing launch products like NREP and Accenture, and ensuring success in overall operational execution. Second, accelerating key assets in our late-stage portfolio, like B783, B784, and Veldatnib in oncology, and EFI in MASH, and in our earlier portfolio, like the ultra-long-acting T-slip for respiratory diseases, and regimen selection for our six-monthly treatment for HIV.
Second accelerating key assets in our late stage portfolio like be 783, <unk> 94, and buildup nib in oncology and in mesh.
In a recent addition of the food allergy <unk> antibody Zurich Rabat is consistent with this.
Underpinning this will be a drive to simplify how we work with greater accountability.
And in our earlier portfolio like the ultra long acting T slim for respiratory diseases and regimen selection, perhaps six monthly treatments for HIV and third continue to execute business development, where we see a clear path to value creation.
Accountability and focus.
And this starts by matching our best people and resources to the best opportunities to create value.
Linked to this changes have already been made to the executive team, bringing on commercial leaders with deep industry experience to increase our focus on products and execution. On this includes <unk>, our new head of global product strategy, who I work with a number of years at Astrazeneca and rushed who will present the commercial update.
In a recent addition of the food allergy <unk> antibody Zurich Rabat is consistent with this.
Speaker #2: And third, continue to execute business development where we see a clear pathway to value creation. And our recent addition of the food allergy IgE antibody, Azuric Rubat, is consistent with this.
Underpinning this will be a drive to simplify how we work with greater accountability.
<unk> and focus.
And this starts by matching our best people and resources to the best opportunities to create value.
And importantly, we will have an increased focus on leveraging practical use of technology and I will now hand over to Nina.
Speaker #2: Underpinning this will be a drive to simplify how we work, with greater pace, accountability, and focus. And this starts by matching our best people and resources to the best opportunities to create value.
A link to this changes have already been made to the executive team, bringing on commercial leaders with deep industry experience to increase our focus on products and execution. On this includes <unk>, our new head of global product strategy, who I work with a number of years at Astrazeneca and rushed who will present the commercial update.
Luke Please turn to the next slide.
Overall sales for the year were up 7% with strong growth driven by specialty up 17% and another year of growth in all regions next slide please.
Speaker #2: Linked to this, changes have already been made to the executive team, bringing on commercial leaders with deep industry experience to increase our focus on products and execution, and this includes Nina Moyas, our new head of global product strategy, who I work with for a number of years at AstraZeneca and Roche, who will present the commercial update.
Respiratory immunology and inflammation full year sales were up 18% driven by strong benlysta and new content performance in.
And importantly, we will have an increased focus on leveraging practical use of technology and I will now hand over to Nina.
In the year Benlysta grew 22% driven by higher demand and supported by all major guidelines, 82%.
Speaker #2: And importantly, we’ll have an increased focus on leveraging practical use of AI and technology. And
Please turn to the next slide.
Overall sales for the year were up 7% with strong growth driven by specialty up 17% and another year of growth in all regions next slide please.
<unk> of U S. Bio naive patients are now starting a mainly due to its differentiated profile with Oregon damage prevention and more than 14 years of safety and experience.
Speaker #2: I'll now hand over to Nina. Thanks.
Speaker #3: Luke, please turn to the next slide. Overall sales for the year were up 7%, with strong growth driven by Specialty up 17%, and another year of growth in all regions.
Respiratory immunology and inflammation full year sales were up 18% driven by strong benlysta and new content performance in.
Cala grew 15% and delivered $2 billion for the year. This is the 10th consecutive year of double digit growth for in Ocala.
Speaker #3: Next slide, please. Respiratory immunology and inflammation full year sales were up 18%, driven by strong Benlysta and Nucala performance. In the year, Benlysta grew 22%, driven by higher demand and supported by all major guidelines.
In the year Benlysta grew 22% driven by higher demand and supported by all major guidelines, 82% of U S. Bio naive patients are now starting and mainly due to its differentiated profile with Oregon damage prevention and more than 14 years of safety and experience.
Moving to oncology sales were up 43%.
In the year and Jim Farley sales were up 89%, reflecting our differentiated profile in endometrial cancer <unk> grew 60% driven by growth in all markets. Following the new data economy, emphasizing the importance of early intervention and based on these data and Citi and included the genre is category one for <unk>.
Speaker #3: Eighty-two percent of US Bionave patients are now starting on Benlysta due to its differentiated profile with organ damage prevention, and more than 14 years of safety and experience.
Cala grew 15% and delivered $2 billion for the year. This is the 10th consecutive year of double digit growth for Nicola.
Speaker #3: Nucala grew 15% and delivered $2 billion for the year. This is the 10th consecutive year of double-digit growth for Nucala. Moving to oncology, sales were up 43%.
<unk> with anemia.
Moving to oncology sales were up 43%.
We expect this to drive uptake in first line all the growth will be slower than what we have seen with second line.
In the year and Jim Farley sales were up 89%, reflecting our differentiated profile in endometrial cancer <unk> grew 60% driven by growth in all markets. Following the new data at <unk>.
<unk> sales decreased reflecting FDA labeling restrictions and we remain focused on the potential we have for blend rate now approved in 50 markets globally.
Speaker #3: In the year, Gemperli sales were up 89%, reflecting our differentiated profile in endometrial cancer. Ojara grew 60%, driven by growth in all markets following the new data at IHA emphasizing the importance of early intervention.
<unk> the importance of early intervention and based on these data and Citi and included the genre is category one for patients with anemia, and we expect this to drive uptake in first line all the growth will be slower than what we have seen with second line.
Deborah will cover HIV short team.
Given the continued strong performance and momentum across the specialty portfolio, we are expecting sales to grow low double digits for 2026.
Speaker #3: And based on these data, NCCN included Ojara as Category 1 for patients with anemia. We expect this to drive uptake in first line; overall growth will be slower than what we have seen with second line.
Next slide please.
Did you lose sales decreased reflecting FDA labeling restrictions and we remain focused on the potential we have for blend rate now approved in 50 markets globally.
The strong performance of new collar in 25 was driven by our successful launch in COPD.
Speaker #3: Zejula sales decreased, reflecting FDA labeling restrictions, and we remain focused on the potential we have for Blandrep, now approved in 15 markets globally. Deborah will cover HIV shortly.
This launch also had a halo effect on all of <unk> indications, resulting in higher market share in asthma and nasal polyps also fueling brand growth in 2006.
Deborah will cover HIV short team.
Given the continued strong performance and momentum across the specialty portfolio, we are expecting sales to grow low double digits for 2026.
We're applying the lessons from the severe asthma market with new color did the launch of expenditure, which is now approved in the U S UK and Japan.
Speaker #3: Given the continued strong performance and momentum across the specialty portfolio, we are expecting sales to grow low double digits for 2026. Next slide, please.
Next slide please.
The strong performance of new collar in 'twenty five was driven by our successful launch in COPD.
We know that there is a significant opportunity to buy a naive population is only 27% of U S eligible patients are on a biologic.
Speaker #3: The strong performance of Nucala in '25 was driven by our successful launch in COPD. This launch also had a halo effect on all of Nucala's indications, resulting in higher market share in asthma and nasal polyps, also fueling brand growth in '26.
This launch also had a halo effect on all of new Carlos indications, resulting in higher market share in asthma and nasal polyps also fueling brand growth in 2006.
And market research shows that 97% of patients would prefer or like to switch to a biologic with six monthly dosing.
We are applying the lessons from the severe asthma market with new color did the launch of expenditure, which is now approved in the U S U K and Japan.
And Accenture has demonstrated a 72% reduction in exacerbations, leading to hospitalizations in an indication where we know like therapy adherence leads to worse clinical outcomes.
Speaker #3: We are applying the lessons from the severe asthma market with Nucala to the launch of Accenture, which is now approved in the US, UK, and Japan.
Know that there is a significant opportunity to bio naive population is only 27% of U S eligible patients are on a biologic.
Speaker #3: We know that there is a significant opportunity in the Bionave population, as only 27% of US eligible patients are on a biologic. And market research shows that 97% of patients would prefer or like to switch to a biologic with six-monthly dosing.
The second key launch this year is for blended our off the shelf be CMA agent for multiple myeloma available in the community setting where 70% of patients are treated.
Market research shows that 97% of patients would prefer or like to switch to a biologic with six monthly dosing.
We've made fast progress on our launch in the UK and are applying lessons learned in the U S, particularly around the eye care networks.
And Accenture has demonstrated a 72% reduction in exacerbations, leading to hospitalizations in an indication where we know like therapy adherence leads to worse clinical outcomes.
Speaker #3: And Accenture has demonstrated a 72% reduction in exacerbations leading to hospitalizations, in an indication where we know lack of therapy adherence leads to worse clinical outcomes.
We've now engaged around 18000 eye care professionals in the U S, enabling smooth collaboration between treating physicians and eyecare professionals and have had positive feedback on the simplification of our rents.
The second key launch this theory for blended our off the shelf be CMA agent for multiple myeloma available in the community setting where 70% of patients are treated.
Speaker #3: The second key launch this year is for Blandrep, our off-the-shelf BCMA agent for multiple myeloma, available in the community setting where 70% of patients are treated.
We continue to expect this to be a slow ramp up as we support prescribers and patients to ensure a positive first experience and robust adoption.
We've made fast progress on our launch in the UK and are applying lessons learned in the U S, particularly around the eye care networks.
Speaker #3: We've made fast progress on our launch in the UK and are applying lessons learned in the US, particularly around eye care networks. We've now engaged around 18,000 eye care professionals in the US, enabling smooth collaboration between treating physicians and eye care professionals.
I will now hand over to Deborah to cover HIV.
We have now engaged around 18000 eye care professionals in the U S, enabling smooth collaboration between treating physicians and eyecare professionals and have had positive feedback on the simplification of our rents.
Thank you Nader, we enter 2026 confidence in a unique position to lead the next transformation in HIV cat.
Sales growth was 11% in the year powered by accelerated patient demand for our long acting injectables and our foundational or two drug regimen <unk>.
We continue to expect this to be a slow ramp up as we support prescribers and patients to ensure a positive first experience and robust adoption.
Speaker #3: And have had positive feedback on the simplification of our REMS. We continue to expect this to be a slow ramp-up, as we support prescribers and patients to ensure a positive first experience and robust adoption.
Demand continued to increase across all regions, most notably in the U S, which grew 14% in 2025, continuing to outpace competition and market share gain.
I will now hand over to Deborah to cover HIV. Thanks.
You need them, we enter 2026 confidence in a unique position to lead the next transformation in HIV cat.
Speaker #3: I will now hand over to Deborah to cover HIV.
Speaker #4: Thank you, Nina. We enter 2026 confident in our unique position to lead the next transformation in HIV care. Sales growth was 11% in the year, powered by accelerated patient demand for our long-acting injectables and our foundational oral two-drug regimens of ARTO.
With the only commercially established long acting HIV treatment regimen backed by over four years of real world data with delivering long acting innovation at scale and are delighted with our ongoing portfolio transition to long acting regimens.
Sales growth was 11% in the year powered by accelerating patient demand for our long acting injectables and our foundational or two drug regimen <unk>.
Demand continued to increase across all regions, most notably in the U S, which grew 14% in 2025, continuing to outpace competition and market share gain.
In 2025, 75% <unk> growth came from long acting Injectables, which now represent around a third of U S sales.
Speaker #4: Demand continued to increase across all regions, most notably in the US, which grew in 2025, continuing to outpace 14% competition in market share gain.
With the only commercially established long acting HIV treatment regimen box by over four years of real World data, we delivering long acting innovation at scale and are delighted with our ongoing portfolio transition to long acting regimens.
With treatment accounting for 90% of the total 22 billion HIV market. We are pleased that cabinet grew 42% in 2025 fueled by patient demand and accelerated switches from competitor products, reaching more than 75% in the U S. This quarter.
Speaker #4: With the only commercially established long-acting HIV treatment regimen, backed by over four years of real-world data, we're delivering long-acting innovation at scale and are delighted with our ongoing portfolio transition to long-acting regimens.
In 2025, 75% of our growth came from long acting Injectables, which now represent around a third of U S sales.
And long acting prevention App achieved grew 62% in 2025 withstanding any impact from a competitor launch in.
Speaker #4: In 2025, over 75% of our growth came from long-acting injectables, which now represent around a third of US sales. With treatment accounting for 90% of the total $22 billion HIV market, we are pleased that Cabinuva grew 42% in 2025, fueled by patient demand and accelerated switches from competitor products, reaching more than 75% in the US this quarter.
With treatment accounting for 90% of the total 22 billion HIV market. We are pleased that cabinet grew 42% in 2025 field by patient demand and accelerated switches from competitor projects, reaching more than 75% in the U S. This quarter.
In 2026, we expect continued growth momentum and so today, we are guiding mid to high single digit growth.
This quarter, we also announced that we'll exit fees and she noted shareholding will increase simplifying the shareholder structure.
Long acting prevention <unk> grew 62% in 2025 withstanding any impact from a competitor launch.
As Kate will maintain the same position, we look forward to continuing our highly successful collaborations to advance our pipeline and portfolio of long acting HIV medicines.
Speaker #4: In long-acting prevention, Apretude grew 62% in 2025, withstanding any impact. In 2026, we expect a competitor launch. Continued growth momentum, and so today we are guiding mid to high single-digit growth.
In 2026, we expect continued growth momentum and so today, we are guiding mid to high single digit growth.
Moving onto our <unk> long acting pipeline powered by unmatched patient insight, we are set to deliver transformative launches over the next decade.
This quarter, we also announced that we'll exit fees and she noted shareholding will increase simplifying the shareholder structure.
Speaker #4: This quarter, we also announced Pfizer will exit ViiV and Shionogi's shareholding will increase, simplifying these shareholder structures. GSK will maintain the same position. We look forward to continuing our highly successful collaboration to advance our pipeline and portfolio of long-acting HIV medicines.
I believe is to navigate the dollar type of bad loss of exclusivity and accelerate long term growth.
Kate will maintain the same position.
We believe twice yearly treatment presents our most significant commercial opportunity and to a combination of novel assets presents the potential to change the HIV treatment paradigm once again.
Look forward to continuing our highly successful collaborations to advance our pipeline and portfolio of long acting HIV medicines.
Moving onto our <unk> long acting pipeline powered by unmatched patient insight, we are set to deliver transformative launches over the next decade, enabling us to navigate the dollar type of weight loss of exclusivity and accelerate long term growth.
Accordingly, we will share data that will help inform our regimen selection for twice yearly HIV treatments.
Speaker #4: Moving on to our INSTI-led long-acting pipeline, powered by unmatched patient insight, we are set to deliver transformative launches over the next decade. This will enable us to navigate the dollar-tag revenue loss of exclusivity and accelerate long-term growth.
Start with V. H, one eight for a potential first in class third generation in state with IP protection three to at least 2014 will present key data on its unique resistance profile. That's the competitor and findings from an ongoing first time in human trial exploring its significant potential for up to twice yearly dosing.
We believe twice yearly treatment present, some nice significant commercial opportunity and through a combination of novel assets presents the potential to change the HIV treatment paradigm once again.
Speaker #4: We believe twice-yearly treatment presents our most significant commercial opportunity and, through a combination of novel assets, presents the potential to change the HIV treatment paradigm once again at Croy.
Accordingly, we will share data that will help inform our regimen selection, but twice yearly HIV treatments.
We strongly believe this asset has the power to redefine the long acting landscape and we remain extremely confident in its potential to become the backbone of a long acting treatment regimens.
Speaker #4: We will share data that will help inform our regimen selection for twice-yearly HIV treatments. Starting with VH184, a potential first-in-class, third-generation INSTI with IP protection through to at least 2040.
Starts with V. H, one eight for a potential first in class third generation in state with IP protection three to at least 2014 will present key data on its unique resistance profile. That's the competitor and findings from an ongoing first time in human trial exploring its significant potential for up to twice yearly dosing.
To pay them without in student selected we are evaluating two partners.
It's 499, and our being up six Atlas data accruing for VX 499 will show potential dosing durations forensics unless one of the broadest and most potent b knobs in development will share more data focused on Q4 and dosing with Q six and dosing data expected this year.
Speaker #4: We'll present key data on its unique resistance profile versus a competitor, and findings from an ongoing first-time in-human trial exploring its significant potential for up to twice-yearly dosing.
We strongly believe this asset has the power to redefine the long acting landscape and we remain extremely confident in its potential to become the backbone of a long acting treatment regimens.
Speaker #4: We strongly believe this asset has the power to redefine the long-acting landscape, and we remain extremely confident in its potential to become the backbone of our long-acting treatment regimens.
To put it without in student selected we are evaluating two partners.
This year, we'll also begin quite trade a phase III Registrational study performance lead HIV treatments. This critical step builds and are key to any success and we are on track to file in 2027 and launch in 2028 at launch we still expect to have the only long acting treatment options on the market for years to come.
Speaker #4: To pair with our INSTI-once-selected, we are evaluating two partners: VH499 and Albina N6LS. Data at Croy for VH499 will show potential dosing durations. For N6LS, one of the broadest and most potent BNABs in development, we’ll share more data focused on Q4M dosing, with Q6M dosing data expected this year.
It's 499 and are being up six Atlas data accruing for VX 499 will show potential dosing durations forensics unless one of the broadest and most potent b knobs in development will share more data focused on Q4 and dosing with Q six and dosing data expected this year.
Our strategy is clear and our execution is strong we are fully confident and well positioned to drive sustained long term performance and we'll continue to update you on our key <unk> regimen selection.
This year, we'll also begin quite track a phase III Registrational study performance lead HIV treatments. This critical step builds and are key to any success and we are on track to file in 2027 and launch in 2028 at launch we still expect to have the only long acting treatment options on the market for years to come.
Speaker #4: This year will also begin quite a Phase 3 registrational study for four-monthly HIV treatment. This critical step builds on our Q2M success, and we are on track to file in 2027 and launch in 2028.
We look forward to introducing you to our new head of R&D, Charlotte Allison, who will succeed Kim Smith upon her retirement at the end of Q1.
Speaker #4: At launch, we still expect to have the only long-acting treatment options on the market for years to come. Our strategy is clear, and our execution is strong.
I'll now hand back to Neenah.
Our strategy is clear and our execution is strong we are fully confident and well positioned to drive sustained long term performance and we'll continue to update you on our key <unk> regimen selection.
Thanks Deborah.
Turning to vaccines sales for $9 2 billion pounds in the year up 2% driven by European and international reach and sales of <unk> and <unk>.
Speaker #4: We are fully confident and well-positioned to drive sustained, long-term performance. And we'll continue to update you on our Q6M regimen selection. We look forward to introducing you to our new head of R&D, Charlotte Allison, who will succeed Kim Smith upon her retirement at the end of Q1.
<unk> sales were $3 6 billion up 8% driven by Europe, and international region offset by the U S.
We look forward to introducing you to our new head of R&D, Charlotte Allison, who will succeed Kim Smith upon my retirement at the end of Q1.
In Europe sales were supported by our focus on comorbid patients and in International region, Japan continued to grow following expanded public funding and in China. We saw similar sales for 2024.
I'll now hand back to Neenah.
Thanks Deborah.
Turning to vaccines sales were $9 2 billion pounds in the year up 2% driven by European and international reach and sales of <unk> and <unk>.
Speaker #4: I'll now hand back to Nina.
Speaker #1: Thanks, Deborah. Turning to vaccines, sales were £9.2 billion in the year, up 2%, driven by European and International region sales of Shingrix and Bexsero.
In 2006, we expect market performance outside of the U S and China to benefit <unk> sales.
<unk> sales were $3 6 billion up 8% driven by Europe, and international region offset by the U S.
Offset to bite slowing U S immunization rates and our partner in China managing inventory.
Speaker #1: Shingrix sales were $3.6 billion, up 8%, driven by Europe and the International region, offset by the US. In Europe, sales were supported by our focus on comorbid patients, and in the International region, Japan continued to grow following expanded public funding. In China, we saw similar sales to 2024.
In Europe sales were supported by our focus on comorbid patients and in International region, Japan continued to grow following expanded public funding and in China. We saw similar sales for 2024 in.
<unk> sales were up 12% with strong continuous growth across Europe, and international driven primarily by big Sarah up 16% for the year Nextera demand increased in Europe, partly due to men B outbreaks.
In 2006, we expect market performance outside of the U S and China to benefit <unk> sales.
Speaker #1: In '26, we expect market performance outside of the US and China to benefit Shingrix sales, offset by slowing immunization rates and our partner in China merging inventory.
Ex U S represented 69% of <unk> global full year sales demonstrating continued growth from national immunization programs.
Offset to bite slowing U S immunization rates and our partner in China managing inventory.
Meningitis sales were up 12% with strong continued growth across Europe, and international driven primarily by big Sarah up 16% for the year Nextera demand increased in Europe, partly due to men b outbreaks ex.
And geographic expansion.
In the U S. We retained munby market leadership with 74% market share and have seen positive signs for mendy with initial stock building.
Speaker #1: In meningitis, sales were up 12%, with strong, continuous growth across Europe and International, driven primarily by Bexsero, up 16% for the year. Bexsero demand increased in Europe partly due to MenB outbreaks.
Turning to <unk> sales were up 2% for the year also driven by ex U S growth.
Ex U S represented 69% of <unk> global full year sales demonstrating continued growth from national immunization programs.
Speaker #1: Ex-US represents 69% of Bexsero's global full-year sales, demonstrating continued growth from national immunization programs and geographic expansion. In the US, we retained MenB market leadership with a 74% market share and have seen positive signs for MenV with initial stock building.
We continue to monitor devolving pediatric vaccine landscape in the U S. At this time insurance coverage remains as before and we expect the recent HHS changes to be manageable given GSK has a broad portfolio of vaccines.
And geographic expansion.
In the U S. We retained munby market leadership with 74% market share and have seen positive signs for mendy with initial stock building.
For 2006, we expect sales growth to be in the range of low single digit decline to stable.
Turning to <unk> sales were up 2% for the year also driven by ex U S growth.
Speaker #1: Turning to Arexi, sales were up 2% for the year, also driven by ex-US growth. We continue to monitor the evolving pediatric vaccine landscape in the US.
Next slide please.
We continue to monitor devolving pediatric vaccine landscape in the U S. At this time insurance coverage remains as before and we expect the recent HHS changes to be manageable given GSK has a broad portfolio of vaccines.
Turning to Genmab.
Sales were slightly down for the year strong growth of trilogy was offset by other respiratory and established products globally challenge continues to be the top selling brand for asthma and COPD and in the U S. The seat classes growing metrology, leading in share driven by gold guidelines and strong execution.
Speaker #1: At this time, insurance coverage remains as before, and we expect the recent HHS changes to be manageable given GSK’s broad portfolio of vaccines. For 2026, we expect sales growth to be in the range of a low single-digit decline to stable.
For 2006, we expect sales growth to be in the range of low single digit decline to stable.
In anti Infectives, we are taking a targeted approach to align access to blue Jetblue in uncomplicated UTI suite positive initial insights and for complicated UTI. We now have a <unk> date of 18 to June for Ted dependent in the U S.
Next slide please.
Turning to Jen Matt.
Speaker #1: Next slide, please. Turning to GenMed, sales were slightly down for the year. Strong growth of Trelegy was offset by other respiratory and established products.
Sales were slightly down for the year strong growth of trilogy was offset by other respiratory and established products globally trilogy continues to be the top selling brand for asthma and COPD and in the U S. The seat classes growing metrology, leading in share driven by gold guidelines and strong execution.
Speaker #1: Globally, Trelegy continues to be the top-selling brand for asthma and COPD, and in the US, the CIT class is growing with Trelegy leading in share, driven by GOLD guidelines and strong execution.
Looking forward, we expect sales growth to be in the range of low single digit decline to stable, reflecting pricing pressures and generic competition of our established portfolio and in the U S across the broader portfolio, we navigated the impact of the Medicare redesign from the inflation reduction Act near the upper <unk>.
In anti Infectives, we are taking a targeted approach to align access to blue Jetblue in uncomplicated UTI suite positive initial insights and for complicated UTI. We now have the Paducah date of 18 to June for Ted dependent in the U S.
Speaker #1: In anti-infectives, we are taking a targeted approach to align access to Blue Zepa in uncomplicated UTIs, with positive initial insights. And for complicated UTIs, we now have a PDUFA date of June 18 for Tebipenem in the US.
And of our $400 million to $500 million range.
I will now hand over to Tony to talk to you about our progress in R&D.
Looking forward, we expect sales growth to be in the range of low single digit decline to stable, reflecting pricing pressures and generic competition of our established portfolio and in the U S across the broader portfolio, we navigated the impact of the Medicare redesign from the inflation reduction Act near the upper <unk>.
Speaker #1: Looking forward, we expect sales growth to be in the range of a low single-digit decline to stable, reflecting pricing pressures and generic competition in our established portfolio.
Thank you Nina next slide please.
Starting with the pipeline theres, greater focus and opportunity to use than ever before.
Speaker #1: And in the US, across the broader portfolio, we navigated the impact of the Medicare redesign from the Inflation Reduction Act near the upper end of our $400 to $500 million range.
<unk> top priority is to accelerate development to deliver new products to patients faster in 2025, we secured five FDA regulatory approvals and started seven new pivotal trials three for expenditure in COPD twofold as soon as Thurman and mash once the valves afternoon in second.
And of our $400 million to $500 million range.
I will now hand over to Tony to talk to you about our progress in R&D.
Speaker #1: I will now hand over to Tony to talk to you about our progress in
Speaker #1: R&D. Thank you,
Thank you Nina next slide please.
Speaker #2: Nina, next slide please. Starting with the pipeline, there's greater focus and opportunity here than ever before. Our top priority is to accelerate development to deliver new products to patients faster.
Starting with the pipeline, there is greater focus and opportunity to use than ever before.
Just on <unk>, all be seven HC ADC in extensive stage small cell lung cancer.
<unk> top priority is to accelerate development to deliver new products to patients faster in 2025, we secured five FDA regulatory approvals and started seven new pivotal trials three for expenditure in COPD twofold as soon as Thurman and mash once the valves afternoon in second.
I'm delighted with the progress, we're making to deliver the pipeline shorten.
Speaker #2: In 2025, we secured five FDA regulatory approvals and started seven new pivotal trials: three for Accenture and COPD, two for Sinusphermin in MASH, one for Valsartanib in second-line GIST, and Rizresor B7H3 ADC in extensive-stage small cell lung cancer.
<unk> time lines and access world, leading innovation through BD next slide please.
In respiratory we've extended our leadership through a focus on exacerbation prevention with long acting treatments and now have approval for extension.
Just under Israels, albeit southern H C. ADC in extensive stage small cell lung cancer.
First in only six months, we biologics to treat patients with severe eosinophilic asthma.
I'm delighted with the progress, we're making to deliver the pipeline shorten development timelines and access world leading innovation through BD next slide please.
Also in respiratory COPD is a growing area of significant unmet need of patients hospitalized with an exacerbation has less than a 50% chance of survival over a five year period, alongside the cost to U S health care of around $7 billion a year.
Speaker #2: Deliver the pipeline, shorten development timelines, and access world-leading innovation through BD. Next slide, please. In respiratory, we've extended our leadership through a focus on exacerbation prevention with long-acting treatments and now have approval for Accenture.
In respiratory we've extended our leadership through a focus on exacerbation prevention with long acting treatments and now have approval for extension.
Work to understand the role of inflammation plays in chronic airway disease has led to an emerging and differentiated pipeline of long acting options for COPD patients.
First in only six months in biologics to treat patients with severe eosinophilic asthma.
Speaker #2: The world's first and only six-monthly severe eosinophilic asthma. Also in respiratory, COPD is a growing area of significant unmet need. A patient hospitalized with an exacerbation has less than a 50% chance of survival over a five-year period.
Also in respiratory COPD is a growing area of significant unmet need of patients hospitalized with an exacerbation is less than a 50% chance of survival over a five year period, alongside the cost to U S health care of around $7 billion per year.
Starting with extension.
His III enduro trials recruit patients with moderate risk of exacerbations, while vigilant as the first ever study of an anti bodies for patients in an early stage of disease, who are at risk of rapid progression a phase II trial investigating the ultra long acting <unk> monoclonal antibody GSK to eight three in asthma patients.
Speaker #2: Alongside a cost to US healthcare of around $7 billion per year, our work to understand the role that inflammation plays in chronic airway disease has led to an emerging and differentiated pipeline of long-acting options for COPD patients.
Work to understand the role of inflammation plays in chronic airway disease has led to an emerging and differentiated pipeline of long acting options for COPD patients.
<unk> is on track to generate data by the end of this year and will further guide development of a six monthly option for patients with a low <unk> phenotype.
Starting with extension of the phase III enduro, Charles recruit patients with moderate risk of exacerbations, while vigilant as the first ever study of an antibody for patients in an early stage of disease, who are at risk of rapid progression a phase II trial investigating the ultra long acting T shirt monoclonal antibody GSK to a <unk>.
Speaker #2: Starting with Accenture, the phase three Endura trials recruit patients at moderate risk of exacerbations, while Vigilant is the first-ever study of an antibody for patients at an early stage of disease who are at risk of rapid progression.
Portfolio also includes a <unk> four inhibitor with potential for DPI use in phase one development in China, complementing our leadership position with trilogy.
Speaker #2: Our phase two trial investigating the ultra-long-acting T-slit monoclonal antibody GSK283 in asthma patients is on track to generate data by the end of this year, and will further guide development of a six-monthly option for patients with a low T2 phenotype.
Looking now to refractory chronic cough I'm pleased to confirm that we achieved last patient first visit for the calm to study in December.
And asthma patients is on track to generate data by the end of this year and will further guide development of six months of the option for patients with a low <unk> phenotype.
We're now on track to report Phase III data from the total program around mid 2026 in line with our prior guidance, we believe coming to fix and we will provide an effective treatments in RCC, where there are no approved therapies in the U S on the <unk>.
The portfolio also includes a PV three four inhibitor with potential for DPI use in phase one development in China, complementing our leadership position with trilogy.
Speaker #2: The portfolio also includes a PD3/4 inhibitor with potential for DPI use in Phase I development in China, complementing our leadership position with Trelegy. Looking now to refractory chronic cough, I'm pleased to confirm that we achieved last patient first visit for the CALM-2 study in December.
Approximately 10 million patients diagnosed globally, who could benefit from this medicine.
Looking now to refractory chronic cough I'm pleased to confirm that we achieved last patient first visit for the <unk> two study in December.
Next slide please.
Our focus on inflammatory pathways of disease and how this leads to fibrosis, particularly in the lung liver and kidney underpins our development programs in fibrosis inflammatory mechanisms. We are pleased with the progress of the thinness Berman our potential best in class once monthly FGF 21, analog which started phase III trials to match that.
We're now on track to report Phase III data from the total program around mid 2026 in line with our prior guidance, we believe come to fix and we will provide an effective treatment in RCC, where there are no approved therapies in the U S and approximately 10 million patients diagnosed globally, who could benefit from this merger.
Speaker #2: And we're now on track to report phase three data from the total program around mid-2026, in line with our prior guidance. We believe Canlapixin will provide an effective treatment in our CC, where there are no approved therapies in the US, and approximately 10 million patients diagnosed globally who could benefit from this medicine.
Yeah as a reminder, in phase II assay demonstrates that sustained improvements in fibrosis and resolution of Nash in patients with <unk> II <unk> III stage disease.
Yeah.
Next slide please.
Speaker #2: Next slide, please. A focus on inflammatory pathways of disease and how this leads to fibrosis, particularly in the lung, liver, and kidney, underpins our development programs in fibro-inflammatory mechanisms.
Our focus on inflammatory pathways of disease and how this leads to fibrosis, particularly in the lung liver and kidney underpins our development programs in fibrosis inflammatory mechanisms. We are pleased with the progress of the thing is firm and a potential best in class once monthly <unk>, one analogue, which started phase III trials to match that.
These data supported the starts of zenith, one and two pivotal studies.
We plan to start the net dealer phase III studies, which will recruit more advanced a full patient population. Later this year also and I'll have to <unk> pipeline as GSK 990, <unk> RNA therapeutics targeting HST 17 be 13, consistent with human genetics of this target preliminary data from the <unk>.
Speaker #2: We are pleased with the progress of Sinusphermin, our potential best-in-class, once-monthly FGF21 analog, which started phase 3 trials for MASH last year. As a reminder, in phase 2, EFI demonstrated its sustained improvement in fibrosis and resolution of MASH in patients with F2 and F3 stage disease.
Yeah as a reminder, in phase II assay demonstrates its sustained improvements in fibrosis and resolution of Nash in patients with <unk> II <unk> III stage disease.
As to Starlight study and alcoholic liver disease demonstrates favorable trends and reduce liver enzymes.
These data supported the starts of Asa and its one in two pivotal studies with.
Speaker #2: These data supported the start of our Zenith one and two pivotal studies. We plan to start the nebula phase three studies, which will recruit a more advanced F4 patient population later this year.
We plan to start the nebulous phase III studies, which will recruit more advanced that full patient population. Later this year also and I'll have to <unk> pipeline as GSK 990, <unk> RNA therapeutics targeting HST 17 be 13.
Ongoing alcohol consumption and this with no emerging safety concerns.
These assets have the potential to reverse cirrhosis with 20% to 50% of patients with associates complications die within one yet.
Speaker #2: Also in our hepatology pipeline is GSK990, an siRNA therapeutic targeting HSD17B13. Consistent with human genetics of this target, preliminary data from the Phase II STARGTIGHT study in alcoholic liver disease demonstrates favorable trends in reduced liver enzymes, despite ongoing alcohol consumption, and this with no emerging safety concerns.
Consistent with human genetics of this target preliminary data from the phase II Starlight study and alcoholic liver disease demonstrates favorable trends and reduce liver enzymes. Despite ongoing alcohol consumption on this with no emerging safety concerns.
Next slide please.
Last month, we were pleased to announce positive results from the <unk>, one and <unk> two studies of <unk>.
Phase III trials of the pay reverse into the treatment of patients with chronic hepatitis b and disease, which affects more than 250 million people worldwide, causing over 1 million deaths each year.
These assets have the potential to reverse cirrhosis with 20% to 50% of patients with associates complications die within one yet.
Speaker #2: These assets have the potential to reverse cirrhosis, where 20% to 50% of patients with associated complications die within one year. Next slide, please. Last month, we were pleased to announce positive results from the BWEL1 and BWEL2 studies of Phase 3 trials of Bepiraversin for the treatment of patients with chronic hepatitis B.
We believe that Betsy has the potential to transform chronic hepatitis C treatments and become the first is a fixed course of therapy with functional cure at a significantly higher rate than today's standard of care. This is important because chronic hepatitis b accounts for around 56% of liver cancer cases, and real world evidence shows that.
Next slide please.
Last month, we were pleased to announce positive results from the <unk>, one and <unk> two studies of <unk>.
Phase III trials of the pay reverse into the treatment of patients with chronic hepatitis b and disease, which affects more than 250 million people worldwide, causing over 1 million deaths each year.
Speaker #2: A disease which affects more than 250 million people worldwide, causing over 1 million deaths each year. We believe that BEPI has the potential to transform chronic hepatitis B treatment and become the first-ever fixed course of therapy with functional cure at a significantly higher rate than today's standard of care.
Functional cure reduces this risk by around 90%, we look forward to sharing these data with regulators during the first half of the year and there is an upcoming scientific Congress next slide please.
We believe the Betsey has the potential to transform chronic hepatitis C treatments and become the first is a fixed course of therapy with functional cure of a significantly higher rate than today's standard of care. This is important because chronic hepatitis b accounts for around 56% of liver cancer cases, and real world evidence shows that.
Our oncology pipeline is a critical part of the portfolio.
Speaker #2: This is important because chronic hepatitis B accounts for around 56% of liver cancer cases, and real-world evidence shows that functional cure reduces this risk by around 90%.
Starting with Blaine, we anticipate material if data from drilling seven and early 2028 to support second line registration in the U S. In the first line transplant ineligible setting dream 10 is recruiting well and we recently expanded the number of U S sites to increase U S patient participation green.
Functional cure reduces this risk by around 90%, we look forward to sharing these data with regulators during the first half of the year and there is an upcoming scientific Congress next slide please.
Speaker #2: We look forward to sharing these data with regulators during the first half of the year and at an upcoming scientific congress. Next slide, please.
Our oncology pipeline is a critical part of the portfolio.
<unk> uses a lower dose when compared to second line studies undervalue, its dual endpoints of MLD and PFS incremental safety data are expected in early 2028.
Speaker #2: Our oncology pipeline is a critical part of the portfolio. Starting with BLENRA, we anticipate mature OS data from June 7 and early 2028 to support second-line registration in the US.
Starting with Blaine, we anticipate material with data from June seven in early 2028 to support second line registration in the U S. In the first line transplant ineligible setting dream Penn is recruiting well and we recently expanded the number of U S sites to increase U S patient participation dream.
Also in the first line setting we'll start a study looking at Blayne Red chord regimen in a younger fitter population later this year move.
Speaker #2: In the first-line, transplant-ineligible setting, June 10 is recruiting well, and we recently expanded the number of US sites to increase US patient participation.
Moving now to ensure we continue to generate data to support decision, making for myelofibrosis patients with anemia.
Speaker #2: June 10 uses a lower dose when it evaluates dual endpoints of MRD and PFS. Intram MRD and safety data are expected in early 2028. Also, in the first-line setting, we'll start a study looking at the BLENRA quad regimen in a younger, fitter population later this year.
<unk> uses a lower dose when compared to second line studies undervalued stool endpoints of MLD and PFS interim MLD and safety data are expected in early 2028.
On the Phase II study in Myelodysplastic syndrome is currently recruiting.
We also continue to develop lifecycle indications for gen poorly.
Also in the first line setting we'll start a study looking at plain Red chord regimen in a younger fitter population later this year.
Later this year, we anticipate results from the pivotal <unk> trial for Gen poorly and DMR locally advanced rectal cancer.
Moving now to ensure we continue to generate data to support decision, making for myelofibrosis patients with anemia, and the phase II study in Myelodysplastic syndrome is currently recruiting.
Speaker #2: Moving now to AJARA, we continue to generate data to support decision-making for myelofibrosis patients with anemia. And a phase 2 study in myelodysplastic syndrome is currently recruiting.
The other one was designed following the publication of transformative data, which showed 100% complete clinical response rate and a single center monotherapy study, we're excited about <unk> potential for patients with this disease.
We also continue to develop lifecycle indications for gen poorly.
Speaker #2: We also continue to develop lifecycle indications for Gemperly. Later this year, we anticipate results from a pivotal AZURE-1 trial for Gemperly in dMMR locally advanced rectal cancer.
Later this year, we anticipated results from our pivotal <unk> trial for Gen poorly and BMO locally advanced rectal cancer.
It's fascinating RK inhibitor, which targets all clinically relevant mutations has started phase III in second line Gist with first line start later this year <unk> has the potential to replace current standards of care and is designed to offer a well tolerated schedule with greater efficacy.
As your one was designed following the publication of transformative data, which showed 100% complete clinical response rate and a single center monotherapy study, we're excited about <unk> potential for patients with this disease.
Speaker #2: Azure One was designed following the publication of transformative data which showed a 100% complete clinical response rate in a single-center monotherapy study. We're excited about Gemperly's potential for patients with this disease.
Against resistant mutations.
Moving now to our other adcs <unk> <unk> targeting molecule, which I will now call <unk> recently received its first regulatory designation with orphan drug status and SC LLC.
I was fascinated RK inhibitor, which targets all clinically relevant mutations has started phase III in second line Gist with first line start later this year <unk> has the potential to replace current standards of care and is designed to offer a well tolerated schedule with greater efficacy.
Speaker #2: Valsartanib, our KIT inhibitor, which targets all clinically relevant enzyme mutations, has started phase three in second-line GIST, with first-line to start later this year.
With this transformative potential in mind, we've initiated a global program encompassing multiple solid tumor trials <unk> call them bold. The first of these studies in bold SCLC <unk> hundred one has started ex U S recruitment in second and third line use.
Speaker #2: Valsartanib has the potential to replace current standards of care, and is designed to offer a well-tolerated schedule with greater efficacy against resistant mutations. Moving now to our other ADCs.
Against resistant mutations.
Moving now to our other adcs.
So the MAGE <unk> targeting molecule, which I will now call <unk> recently received its first regulatory designation with orphan drug status and SC LLC.
Speaker #2: Our B7H3-targeting molecule, which I will now call Rizrez, recently received its fifth regulatory designation with author and drug status in FCLC. With this transformative potential in mind, we've initiated a global program encompassing multiple solid tumor trials for Rizrez called Embold.
S recruitment will start later this year and include <unk> exposed patients. We have extensive plans for additional raise raised phase III starts in the next 12 to 18 months in the first half of this year. We also plan to start recruitment for pivotal phase III trials, some Morris obese as an H for ADC in platinum resistant.
With this transformative potential in mind, we've initiated a global program encompassing multiple solid tumor trials for <unk> call them bold. The first of these studies in bold SCLC 301 has started ex U S recruitment in second and third line use recruitment will start later this year and include toddler.
Speaker #2: The first of these studies, in bold—FCLC 301—has started ex-U.S. recruitment in second and third line. U.S. recruitment will start later this year and include Tarlatamab-exposed patients.
Into very intensive unearned patients with recurrent endometrial cancer.
We're targeting a conference this year to present interim data from our early phase Behold, one study for patients with ovarian and endometrial cancers, and we anticipate further pivotal study starts for this molecule during 2026 next slide please.
Some of the exposed patients we have extensive plans for additional raise raised phase III starts in the next 12 to 18 months in the first half of this year. We also plan to start recruitment for pivotal phase III trials for <unk> <unk> ADC in platinum resistant ovarian cancer unearned patients with recurrent <unk>.
Speaker #2: We have extensive plans for additional Rizrez phase three starts in the next 12 to 18 months. In the first half of this year, we also plan to start recruitment for pivotal phase three trials for MoRes, our B7H4 ADC in platinum-resistant ovarian cancer, and in patients with recurrent endometrial cancer.
Business development is a core part of how we're accelerating our pipeline and accessing innovation two weeks ago, We announced an agreement to acquire rapt therapeutics who's the lead asset is <unk>.
Actual cancer.
We're targeting a conference this year to present interim data from our early phase Behold, one study for patients with ovarian and endometrial cancers, and we anticipate further pivotal study starts for this molecule during 2026 next slide please.
Speaker #2: We're targeting a conference this year to present interim data from our early phase BHOLD1 study for patients with ovarian and endometrial cancers, and we anticipate further pivotal study starts for this molecule during 2026.
Our potential best in class long acting anti <unk> monoclonal for food allergy, which is currently in phase III food allergy is a chronic inflammatory condition with severe reactions, leading to anaphylaxis emergency care and persistent lifestyle disruption in the U S severe food allergies impact over 17 million patients with an.
Speaker #2: Next slide, please. Business development is a core part of how we're accelerating our pipeline and accessing innovation. Two weeks ago, we announced an agreement to acquire RAP Therapeutics, whose lead asset is OzuReprobot.
This development is a core part of how we're accelerating our pipeline and accessing innovation two weeks ago, We announced an agreement to acquire rapt therapeutics who's the lead asset is <unk> a potential best in class long acting anti <unk> monoclonal for food allergy, which is currently in phase III food allergy is a chronic <unk>.
<unk> 33 billion cost of economic burden underscoring the need for more effective treatment options. We expect the deal to close this quarter and look forward to progressing this important assets into phase III development.
Speaker #2: A potential best-in-class long-acting anti-IgE monoclonal for food allergy, which is currently in Phase 2. Food allergy is a chronic inflammatory condition with severe reactions leading to anaphylaxis, emergency care, and persistent lifestyle disruption.
Financial condition with severe reactions, leading to anaphylaxis emergency care and persistent lifestyle disruption in the U S. Severe food allergies impact over 17 million patients with an estimated 73 billion cost of economic burden underscoring the need for more effective treatment options. We expect the deal to close this call.
Next slide please.
In conclusion 2025 sources of strong momentum in the pipeline, which continues into 2026, we have critical data readouts to come for Betsy calmly gym per the Q4 and prep and extend shirt for GPA.
Speaker #2: In the US, severe food allergies impact over 17 million patients, with an estimated $33 billion cost of economic burden, underscoring the need for more effective treatment options.
Also have 10 pivotal starts planned for this year, including more than fine from our adcs to four events smashed on quattro, our Q4 and treatment phase III trial for HIV, all of which are supporting our growth in specialty medicines I'm excited about our progress and our prospects I'll now hand over to Julie.
Speaker #2: We expect the deal to close this quarter and look forward to progressing this important asset into phase three development. Next slide, please. In conclusion, 2025 saw further continues into 2026.
And look forward to progressing this important asset into phase III development next.
Slide please.
In conclusion 2025 sources of strong momentum in the pipeline, which continues into 2026, we have critical data readouts to come for Betsy calmly gym per the Q4 and prep and extensions for GPA.
Speaker #2: We have critical data readouts to come for BEPI, CAMLI, Gemperly, Q4 MPREP, and the extension for EGPA. We also have 10 pivotal starts planned for this year, including more than five from our ADCs.
Thank you Tony and good afternoon, everyone next slide please.
Starting with the income statement for the full year with Great stated at CER as highlighted sales grew 7% core operating profit grew 11%.
So have 10 pivotal starts planned for this year, including more than fine from our adcs to four events mash on quattro, our Q4 and treatment phase III trials for HIV, all of which are supporting our growth in specialty medicines I'm excited about our progress and our prospects I'll now hand over to Julie.
Speaker #2: Two for advanced MASH and Quattro are Q4 'M' treatment phase three trials for HIV. All of which are supporting our growth in specialty medicines.
This leverage was primarily driven by a 3% increase in SG&A as investments in private loan changed was balanced with productivity improvements.
Speaker #2: I'm excited about our progress and our prospects.
Additionally, royalty income benefited from the IRS the IP settlement.
Thank you Tony and good afternoon, everyone next slide please.
A new mrna royalty streams and <unk> to performance on R&D growth of 11% reflects an acceleration of investment across multiple key specialty assets.
Starting with the income statement for the full year with Great stated at sea.
As highlighted sales grew 7% while its core operating profit grew 11%.
This leverage was primarily driven by a 3% increase in SG&A as investments in private loan changed was balanced with productivity improvements.
Core EPS grew 12% supported by the share buyback and lower interest expense due to strong operating cash flows.
Additionally, royalty income benefited from the RSV IP settlement.
And finally, turning to total results.
Growth primarily reflects the impact of this one time charge taken in 2024 next slide please.
A new mrna royalty streams and <unk> to performance on R&D growth of 11% reflects an acceleration of investment across multiple key specialty assets.
The operating margin increased 110 basis points in 2025, bringing total accretion, let's see you know, it's just 270 bps over the last four years.
Core EPS grew 12% supported by the share buyback and lower interest expense due to strong operating cash flows.
This increase was primarily driven by SG&A margin improvement of 90 bps.
And finally, turning to total results.
Growth primarily reflects the impact of <unk> charge taken in 2024 next slide please.
Gross margin continued to benefit from the portfolio transition towards specialty growing 40 basis points.
The operating margin increased 110 basis points in 2025, bringing total accretion, let's see you know, it's just 270 bps over the last four years.
R&D expenditure increased as we reinvested the additional royalty income into our pipeline to support the initiation of the phase III as I'm, assuming trials unprepared pivotal trials for the adcs in multiple indications.
This increase was primarily driven by SG&A margin improvement of 90 bps.
Incorporated within this margin improvement were cool charges of 300 million pounds taken in Q4 split evenly across supply chain and SG&A to drive productivity benefits.
Gross margin continued to benefit from the portfolio transition towards specialty growing 40 basis points.
R&D expenditure increased as we reinvested the additional royalty income into our pipeline to support the initiation of the phase III <unk> trials unprepared pivotal trials for the adcs in multiple indications.
And currency was a headwind to margin lowering the reported margin to 29, 9% for the year next slide please.
Turning to the cash flow cash generated from operations was $8 9 billion pounds or more than 10 billion exclude these one time payments of $1 6 billion year on year, driven by higher operating profits favorable movements on the <unk> settlement.
Incorporated within this margin improvement were cool charges of 300 million pounds taken in Q4 split evenly across supply chain and SG&A to drive productivity benefits.
Currency was a headwind to margin lowering the reported margin to 29, 9% for the year next slide please.
Recently offset by increased trade receivables.
Free cash flow increased to 4 billion pounds or more than $5 billion, excluding zantac driven by strong see GSO.
Turning to the cash flow cash generated from operations was $8 9 billion pounds or more than 10 billion, excluding Zen type payments.
It sounds like payments in 2025 were $1 2 billion pounds in the settlement process is now materially complete with $1 9 billion paid in total drawing a line under this master next slide please.
One 6 billion year on year, driven by higher operating profits favorable movements on the kill that settlement, partially offset by increased trade receivables.
Turning to capital allocation.
Free cash flow increased to 4 billion pounds or more than 5 billion, excluding <unk> driven by strong see GSO.
Underlying free cash generation was strong with over $8 billion before an investment decision.
More than a half billion was deployed in capex in BD as we know.
It sounds like payments in 2025 were $1 2 billion pounds on the settlement process is now materially complete with $1 9 billion paid in total drawing a line under this master next slide please.
Three potentially best in class clinical stage specialty assets to the pipeline uncompleted multiple early stage and platform deals.
Shareholder distributions totaled 4 billion through the dividend on the share buyback with 93 million shares repurchased at an average price of $14 73, and the remaining six of the $1 billion will be completed in half one.
Turning to capital allocation underlying free cash generation was strong with over $8 billion before investment decisions four and a half billion was deployed in capex in BD as we added three potentially best in class clinical stage specialty assets to the pipeline uncompleted multiple early stage and platform deals.
Overall, our balance sheet remains strong with net debt to EBITDA relatively stable year on year at one three times, including the absorption of zantac on the buyback next slide please.
Shareholder distributions totaled 4 billion through the dividend on the share buyback was 93 million shares repurchased at an average price of $14 73, and the remaining six of the $1 billion will be completed in half one.
Now turning to the guidance for 2026 with growth rates stated at sea.
Starting with the headline guidance, we expect sales base of 3% to 5% core operating profit and core EPS to both grow at 7% to 9% underpinned.
Overall, our balance sheet remains strong with net debt to EBITDA relatively stable year on year at one three times, including the absorption of zantac on the buyback next slide please.
And you pay a dividend of 70 pounds, a 6% increase.
<unk> growth was once again led by specialty.
Low double digit percentage growth, including mid to high single digit growth for HIV.
Now turning to the guidance for 2026 with growth rates stated at sea.
It seems in Gen. Med are both expected to be in low single digit decline to stable and we expect sales growth to be evenly phased through the year.
Starting with the headline guidance, we expect sales growth of 3% to 5% core operating profit and core EPS to both grow at 7% to 9%.
Turning to the P&L gross margin is expected to continue to benefit from supply chain efficiencies on the portfolio transition towards specialty.
And to pay a dividend of 70 pounds, a 6% increase.
<unk> growth was once again led by specialty.
Low double digit percentage growth, including mid to high single digit growth range I V.
SG&A will grow at a low single digit percentage benefiting from the acceleration of productivity initiatives.
That seems in Gen. Med are both expected to be in low single digit decline to stable and we expect sales growth to be evenly phased through the year.
R&D will continue to grow ahead of sales as we invest to advance the pipeline.
Interest charges and the tax rate are expected to increase year on year. However, these will be offset by the benefits of the share buyback to Etfs.
Turning to the P&L gross margin is expected to continue to benefit from supply chain efficiencies on the portfolio transition towards specialty.
Importantly, the phasing of operating profit growth will be heavily weighted towards the second half, reflecting the 300 million pounds of charges taken in Q4 'twenty five.
SG&A will grow with the low single digit percentage benefiting from the acceleration of productivity initiatives.
R&D will continue to grow ahead of sales as we invest to advance the pipeline.
And impacted by the annualized nation of the RAC settlement in the second quarter.
Interest charges and the tax rates are expected to increase year on year. However, these will be offset by the benefits of the share buyback to Etfs.
Additionally, currency could be a headwind if rates hold at the closing rates on the 20th of January we would expect an impact of minus 3% on sales of minus 6% and operating profit next slide please.
Importantly, the phasing of operating profit growth will be heavily weighted towards the second half, reflecting the 300 million pounds of charges taken in Q4 'twenty five.
Before I finish I wanted to take a moment to share the continued performance of the business.
Impacted by the annualized nation of the RAC settlement in the second quarter.
In 2021, we've provided outlooks on full financial Kpis for the five year period to 2026.
Additionally, currency could be a headwind if rates hold at the closing rates on the 20th of January we would expect an impact of minus 3% on sales of minus 6% and operating profit next slide please.
We have delivered consistent revenue growth and improvements in operational efficiency.
We are on track to deliver against all the fool Kpis.
Taking the midpoint of our 2026 guidance ranges would lead to delivery of 8% sales.
Before I finish I wanted to take a moment to share the continued performance of the business.
In 2021, we've provided outlooks on full financial Kpis for the five year period to 2026.
13% operating profit Tiger over this period. Additionally.
Additionally, cash generation has been significantly enhanced and we're on track to reach more than 10 billion pounds in 2026.
We have delivered consistent revenue growth and improvements in operational efficiency.
This together with shareholder returns and a strengthened balance sheet laid strong foundations for the next phase of growth.
We are on track to deliver against all the fool Kpis.
Taking the midpoint of our 2026 guidance ranges would lead to delivery of 8% sales.
As you will I a roadmap as shown in the appendix signaling the major value inflections in 2026 and 27.
15% operating profit Tiger over this period.
Thank you and with that I'm pleased to hand back to Luke.
Cash generation is being significantly enhanced and we're on track to reach more than 10 billion pounds in 2026.
Thanks, Julie looking forward I would say to clear things, we need to do to create value for shareholders. The first one is top line. This means delivering on our ambition for 2031 and addressing the loss of dollar took a bit of exclusivity. The second is the bottom line, we need to accelerate what we have and add to advanced smart BD and we also need all of that.
This together with shareholder returns and a strengthened balance sheet laid strong foundations for the next phase of growth.
Usual I a roadmap as shown in the appendix signaling the major value inflections in 2026 and 27.
<unk> to produce more competitive products.
Thank you and with that I'm pleased to hand back to late.
Do these three things we need to evolve as a company.
Thanks, Julie looking forwards I say to clear things, we need to do to create value for shareholders. The first one is top line. This means delivering on our ambition for 2031 and addressing the loss of <unk> exclusivity. The second is the bottom line, we need to accelerate what we have and add to advanced <unk> and.
Products are the key in this business and we need to be more product centric.
And to accelerate the bottom line, we need to have both sides of the courage and be more agile to capitalize on opportunities when we see them each quarter, you'll hear more detail about how we're going to make this happen next slide please.
Julie Brown: Impairment charges of GBP 300 million taken in Q4, split evenly across supply chain and SG&A to drive productivity benefits. Currency was a headwind to margin, lowering the reported margin to 29.9% for the year. Next slide, please. Turning to the cash flow, cash generated from operations was GBP 8.9 billion, or more than GBP 10 billion excluding Zantac payments, up GBP 1.6 billion year-over-year, driven by higher operating profit, favorable RAR movements, and the CureVac settlement, partially offset by increased trade receivables. Free cash flow increased to GBP 4 billion, or more than GBP 5 billion excluding Zantac, driven by strong CGFO. Zantac payments in 2025 were GBP 1.2 billion, and the settlement process is now materially complete, with GBP 1.9 billion paid in total, drawing a line under this matter. Next slide, please. Turning to capital allocation, underlying free cash generation was strong at over GBP 8 billion before investment decisions.
Julie Brown: Impairment charges of GBP 300 million taken in Q4, split evenly across supply chain and SG&A to drive productivity benefits. Currency was a headwind to margin, lowering the reported margin to 29.9% for the year. Next slide, please. Turning to the cash flow, cash generated from operations was GBP 8.9 billion, or more than GBP 10 billion excluding Zantac payments, up GBP 1.6 billion year-over-year, driven by higher operating profit, favorable RAR movements, and the CureVac settlement, partially offset by increased trade receivables. Free cash flow increased to GBP 4 billion, or more than GBP 5 billion excluding Zantac, driven by strong CGFO. Zantac payments in 2025 were GBP 1.2 billion, and the settlement process is now materially complete, with GBP 1.9 billion paid in total, drawing a line under this matter. Next slide, please. Turning to capital allocation, underlying free cash generation was strong at over GBP 8 billion before investment decisions.
To conclude 2025 was a strong year for GSK for 2026 regarding for another year of topline growth and operating leverage and.
We also need our labs to produce more competitive products. So to do these two things we need to evolve as a company.
Products are the key in this business and we need to be more product centric.
And for the long term, we know what we need to do to create value for shareholders and patients in the <unk>.
And to accelerate the bottom line, we need to have both sides of the courage and be more agile to capitalize on opportunities, let me say them each quarter, you'll hear more detail about how we're going to make this next slide please.
Focus is now on evolving the company to do it. Thank you I will now move to Q&A.
Yeah.
Thank you Luke with this we're ready for the Q&A.
To conclude 2025 was a strong year for GSK for 2026, we're guiding for another year of top line growth and operating leverage and for the long term, we know what we need to do to create value for shareholders and patients and the focus is now on evolving the company to do it. Thank you I will now.
First question comes from James Gordon from Barclays.
Go ahead.
Yeah.
Hello, James Goodman from Barclays. Thanks for taking the questions.
First one on respiratory.
Can you elaborate on R&D and commercial strategy in COPD and asthma.
Move to Q&A.
And you call it expense.
Yeah.
And then all of a thirty-three mt's that ruling development some overlapping photos.
Thank you Luke with this we're ready for the Q&A. That's the first question comes from James Gordon from Barclays. Please go ahead.
I want to double count so for how do we think about segmenting. This given you got products going through the same disease and also call. All these mechanisms also multiple competitor is also looking at them for the same diseases.
Julie Brown: 4.5 billion was deployed in CapEx and BD as we added three potentially best-in-class clinical-stage specialty assets to the pipeline, and completed multiple early-stage and platform deals. Shareholder distributions totaled GBP 4 billion through the dividend and the share buyback, with GBP 93 million shares repurchased at an average price of GBP 1,473, and the remaining GBP 0.6 billion will be completed in H1. Overall, our balance sheet remained strong, with net debt to EBITDA a relatively stable year-on-year at 1.3x, including the absorption of Zantac and the buyback. Next slide, please. Now turning to the guidance for 2026, with growth rates stated at CER. Starting with our headline guidance, we expect sales growth of 3% to 5%, core operating profit, and core EPS to both grow at 7% to 9%, and to pay a dividend of GBP 0.70, a 6% increase.
Julie Brown: 4.5 billion was deployed in CapEx and BD as we added three potentially best-in-class clinical-stage specialty assets to the pipeline, and completed multiple early-stage and platform deals. Shareholder distributions totaled GBP 4 billion through the dividend and the share buyback, with GBP 93 million shares repurchased at an average price of GBP 1,473, and the remaining GBP 0.6 billion will be completed in H1. Overall, our balance sheet remained strong, with net debt to EBITDA a relatively stable year-on-year at 1.3x, including the absorption of Zantac and the buyback. Next slide, please. Now turning to the guidance for 2026, with growth rates stated at CER. Starting with our headline guidance, we expect sales growth of 3% to 5%, core operating profit, and core EPS to both grow at 7% to 9%, and to pay a dividend of GBP 0.70, a 6% increase.
Hello, James Gordon from Barclays. Thanks for taking the questions.
The second question was with HIV and I heard the comments on relapsing strong uptake and exciting next generation data Corey.
First one respiratory can you elaborate on R&D and commercial strategy in COPD and asthma.
So when could we see the six monthly treatment.
What do you call it expense.
And then O thirty-three mtc all in development some overlapping products.
Phase III trials start now.
And commercially what is the implications of the four months six monthly in terms of your time, because I've seen before you talked about the majority of sales in HIV being long acting in 2031 within that month, partly just because the orders are going to go away by then so what's the time increase if these were maybe focus with squeezing a clarification that the 40 billion plus revenue target.
When the double count and if so how do we think about segmenting. This given yugo products going through the same disease and then also call out. These mechanisms also multiple competitors also looking at them for the same diseases.
The second question was with HIV and I heard the comments on no not seeing strong uptake of exciting next generation data Corey.
So when could we see the six monthly treatment phase.
Which has been reiterated is that the original assets or is that also including some of the recent acquisitions you were talking about the BD youre talking about please.
Phase III trials start now.
And commercially.
Is the implications of the four months six monthly in terms of your time, because I've seen before you talked about the majority of sales in HIV being long acting in 2031 within that month, partly just because the orders are going to go away by then so what's the time increase that these work maybe focus with squeezing a clarification did the 40 billion plus revenue target, which has been reiterated.
Brian Thanks, John I appreciate the question so.
Shall we.
Go into CIP day, and then I might add a little bit of color at.
At the end of that in terms of how we position the assets and what our thinking is it's obviously always dynamic.
And then Deborah do you want to cover that kind of thing I think we're in very healthy shape. It.
Is that the original assets or is that also including some of the recent acquisitions you were talking about from the BD Youre talking about please.
Julie Brown: Product area growth is once again led by Specialty, as a low double-digit percentage growth, including mid- to high single-digit growth for HIV. Vaccines and GenMed are both expected to be a low single-digit decline to stable.
Julie Brown: Product area growth is once again led by Specialty, as a low double-digit percentage growth, including mid to high single-digit growth for HIV. Vaccines and GenMed are both expected to be at a low single-digit decline to stable.
Some more color there and then Julian just want to cover the assumptions around that 40 again I'll just take this opportunity just in case, we get any other questions to reiterate the commitment to the <unk> 40.
Alright, Thanks, John I appreciate the question so.
Chinese shall we.
And again I think we have a clear pathway for that.
Go into CIP day, and then I might add a little bit of color at.
Alright.
At the end of that in terms of how we position the assets and what our thinking is it's obviously always dynamic.
Let me start thanks for the question James first of all I'm really pleased with the progress we're making in respiratory obviously you just have more questions than you color approval in COPD in the middle of the Air and then at the end of the year expenditure in serious and until our customers see.
And then separately you want to cover I try to think I think we're in a very healthy shape. It.
Some more color there and then Julian just want to cover the assumptions around the 40 again I'll just take this opportunity just in case, we get any other questions to reiterate the commitment to the <unk> 40.
Social long acting entry into our pipeline I think what's important to understand about COPD, James obviously huge opportunity that 300 million individuals globally.
And again I think we have a clear pathway for that.
Alright.
Let me start thanks for the question James first of all I'm really pleased with the progress we're making in respiratory obviously, you just have more glass than you color approval in COPD in the middle of the Air and then at the end of this year expenditure and serious and for our customers.
Significant cost to the U S health care system as I outlined in the presentation, but it's a complex disease, it's a heterogeneous.
And that's why we're placing ourselves across a range of different long acting mechanisms. The way you can think about it is there is the high Eo population. This is where IL fives and expenditure in your color off positions and again I would just emphasize that though we have a label which covers both the bone Ketchikan began to see in a mixed population.
Social long acting entry into our pipeline I think what's important to understand about COPD, James obviously huge opportunity that 300 million individuals globally.
Significant cost to the U S health care system as I outlined in the presentation, but it's a complex disease, it's a heterogeneous.
Quarter by maybe wait when one considers the reality of the hospitalization for COPD patients.
And that's why we're placing ourselves across a range of different long acting mechanisms. The way you can think about it is there is the high Eo population. This is where IL five and extension and your color off positions and again I would just emphasize that we have a label which covers both the bone ketchikan the emphysema mixed populations.
You can then think about the intermediate to population, which is the 150 to 300, we were delighted to see the new color label there, but that's why we see for example, our long acting peacefully starting to play increasingly in the future and then the low <unk> population and that's where we're positioning IL 33, so while we.
Portland.
When one considers the reality of the hospitalization for COPD patients.
We have of course is already starting in the <unk> population in June of one and two studies. That's the goal the population that we're looking at.
You can then think about the intermediate to population, which is the $1 50 to 300, we were delighted to see the new color label that but that's why we see for example, how long acting peacefully starting to play increasingly in the future and then below <unk> population and that's where we're positioning the IL 33, so well.
And the vigilant study, which as I mentioned in the script looks as a brand new approach looking at rapid progresses and not high eosinophil population. We also have ongoing phase one and phase two studies for the long acting fee splits and the IL 33 mechanisms in the context of the stratification that I described.
We have of course is already starting in the <unk> population and jewelry were one and two studies. That's the goal the population that we're looking at.
And then just to finish off we will be expecting.
In both of those to be starting.
And the vigilant study, which as I mentioned in the script looks as a brand new approach looking at rapid progresses and not high eosinophil population. We also have ongoing phase one and phase two studies for the long acting piece, but it's.
Pivotal studies over the next two to three years once we have been informed by ongoing phase one and phase two work on competitor insights.
And then lastly, just to finish off important to emphasize we also absolutely HRS 98 to one molecule, which is the first nominated candidate from our growing collaboration that's focused on this fan which has some associated pain associated with breathing and fits nicely into our strategy portfolio gives them.
The IL 33 mechanisms in the context of the stratification that I described and then just to finish off.
Be expecting.
Both of those to be starting.
Pivotal studies over the next two to three years once we have been informed by ongoing phase one and phase two work on competitor insights.
That molecule is an opportunity to be at the EPA.
As Vince to agents and then lastly in the <unk>.
And then lastly, just to finish off important to emphasize we also have the HRS 98 to one molecule, which is the first nominated candidate from our ongoing collaborations.
<unk> group, we have the recent deal we did with <unk> and <unk> two in that cycle of GSK to one.
Long acting all ago, which is aimed at a broad spectrum as I indicated we haven't disclosed the mechanism.
<unk> not focused on this fan, which has some associated pain associated with raising it fits nicely into our strategy portfolio, given though that molecule as an opportunity to be a DPI administered agents and then lastly.
In future as we gather more data.
James What I will say is we got to resist.
The penetration is a currently to construct a lovely Powerpoint slide that shows how won't pay if we capture this space and have trade offs among stopped products I mean, they're a strategic intent but.
Low group, we have the recent deal we did with <unk> and <unk> two in that cycle of GSK to one that's a long acting all ago, which is aimed at a broad spectrum as I indicated we haven't disclosed the mechanism.
But we also recognize there's a darwinian dimension here.
In terms of the data that these targets generate but also the competition gets adopted as well.
In the future as we gather more data.
Ultimately the long acting as the future the launch for new Commerce COPD in the U S is going very well.
And James what I will say is begun to resist.
The penetration as a currently to construct a lovely Powerpoint slide that shows how we typically capture this space.
And was just there on Monday, we have around as well, depending on which to us at 43% to 46% of new patient starts already.
Tradeoffs amongst our products I mean, they're a strategic intent.
But we also recognize there's a darwinian dimension here in.
Our market research that messaging is really resonating thoughts we have transferred all of our new Calder reps sort of Accenture and new colleagues COPD is being promoted by the trilogy legacy pain, because again, we need to place our bets on the future.
In terms of the data that these targets generate but also the competition gets about as well I mean, ultimately long acting as the future the launch for new Commerce COPD in the U S is going very well.
And was just there on Monday, we have around as well, depending on which to us at 43% to 46% of new patient starts already.
And the ultimate future with the file buys and higher. He also is going to be long acting adventure for COPD side. Thanks, guys. I. Appreciate that question Deborah if you want to give it up it sounds like so.
Our market research and our messaging is really resonating.
We have transferred all of our new Calder reps sort of Accenture and new colleagues COPD is being monitored by the trilogy legacy team because again, we need to place a bet on the future.
The key thing that I want to reemphasize is that we're on track to select hockey sticks out a treatment regimen.
In the middle of the year and as I said, we're gonna do I meet the management to then.
The ultimate future wins for file buys.
Yeah, well, that's a lot more detail about the pipeline, but let me just give you a top line would be now so let's start with treatment. The pickup market is 20 billion in value, 90% of the values at the title HIV market.
He also is going to be long acting adventure for COPD side. Thanks, Brian I appreciate that question.
Do you want give it up it sounds like so.
The key thing that I want to reemphasize is that we're on track to select hockey sticks out a treatment regimen.
As I said in my presentation, Q, six and is clearly our biggest opportunity in treatment.
In the middle of the year and as I said, we're going to do.
We're very confident in the assets that we've got to choose from on the Kuwait data that we'll present will show just how strong Davis.
The management has been made.
Yeah, well, that's a lot more detail about the pipeline, but let me just give you a top line would be now so let's start with treatment. The pickup market is 20 billion in value, 90% of the values at the title HIV market.
Assets I'll take can be a 184, which is unique third generation really tightened integrate inhibitor and we believe that to have a really potent regimens you need to have an integrase inhibitor of coal.
As I said in my presentation, Q, six and is clearly our biggest opportunity in treatments.
So in terms of well.
We're very confident in the assets that we've got to choose from and the Kuwait data that we'll present will show just how strong those assets.
Kind of when studies will start.
<unk> 6000 treatment you will see us move into phase two b this year.
That puts us on track for our commitment, which is the 28 to Betsy launch for our acoustic semi treatment in terms of prep, it's a different pathway because with the medicine that we're developing for Q six seven it's a pro drug effect habitat, Colgate, which we've talked about before.
Assets I'll take can be H, 184, which is unique third generation really types and integrate inhibitor and we believe that to have a really potent regimens you need to have an integrase inhibitor Nicole.
So in terms of Paul.
Kind of when study tour stops.
On Tuesday, seven treatment, you will see us move into phase two basis yeah.
And that means that we'll be able to go from phase one to phase III relatively rapidly on the phase one will be starting this year, where it was then.
That puts us on track for our commitment which is the 28 to Betsy.
Progressive dose selection and then we'll do a bridging study from the data that we already have from Q2 and so on.
The launch for <unk> six I mean treatment in terms of prep, it's a different pathway because with the medicine that we're developing for Q six seven it's a pro drug effect habitat innovate, which we've talked about before.
Cheese sticks out in pathway is clear.
Very confident in our ability to deliver against our milestones.
That means that we'll be able to go from phase one to phase III relatively rapidly on the phase one will be starting this year, where it was.
But don't underestimate Q4, and there is a huge desire for Q4 any treatment and then Brett.
Many clinicians are really looking forward to I can get that clinic capacity, which will double from what they've got today, even Q2 and the key for them and I think what you're going to see is around the cannibalization to Q2 to Q4, and then actually you will see a rapid cannibalization from Q4 to Q six.
Progressive dose selection and then we'll do a bridging study from the data that we already have from Q2 I would say.
And she's six out of the pathway is a clear I'm sorry.
Very confident in our ability to deliver against our milestones.
But don't underestimate Q4, and there is a huge desire for Q4 any treatment arms in prep and we know that many clinicians are really looking forward to I can get that capacity, which will double from what they've got today are the key to them, but key for them and I think what you're going to see is around cannibalization.
And as I've said before particularly in treatment you see the market really open up as we progressed through longer and longer durations between administration, so the addressable market for cheap.
Kind of when studies, all start, um, q6 and treatment, you'll see us move into phase 2B this year. Um, that puts us on track for our commitment, which is uh, the 28th of 30, uh, launch for our q6 m in treatment, in terms of prep, it's a a different pathway because with the medicine that we're developing for q6 M prep, it's a pro DG of capacity which we've talked about before and that means that we'll be able to uh go from Phase 1 to phase 3 relatively rapidly. And the phase 1 will be uh starting this year where we'll then progress the dose selection and then we'll do a bridging study from the data that we already have from q2m. So
Uh, 26m pathway is, uh, clear and we're very confident in our ability to deliver, uh, against our milestones.
To them, it's about 15% of patients when we get to full we get to 30% of patients and then you've got with key sending treatment, 50% of patients who would be very willing to take a long acting injectable that is a big chunk of the market, which is why we are so excited about the offering acoustics.
Q2, and to Q4, and then actually you will see a rapid cannibalization from Q4 to Q six and as I've said before particularly in treatment you see the market really open up as we progress through longer and longer durations between administration. So the addressable market for <unk>.
Treatment and Democrats particular treatment what else. Thanks, Derrick drilling quick answer on the on the Pony I think everyone knows but let's confirm it yeah sure. Thanks Jami for the question.
The key to them is about 15% of patients when we get to full we get to 30% of patients and then you've got with key sending treatment 50% of patients.
And what we've included in the recent deals <unk> is included in the seven together with them. These strange hungerly licensed PD faithful right. So obviously, it's just been announced and it can also included a total of yellow or red.
Would be very willing to take a long acting injectable that is a big chunk of the market, which is why we're so excited.
About the offering that keeps extending treatment and incorrect, but particularly in treatment.
And clearly we continuously mentioned.
Thanks, Deborah drilling quick answer on the on the Pony.
To support our Bay day to build and continue to build the pipeline Brian. Thanks, John next.
Everyone knows but let's confirm it yeah sure. Thanks, James for the question. So in terms of what was included in the recent deals IV. Rx is included in the salmon together with them. Yeah. These day change really licensed PD wasteful.
Next question. Please thanks guys next question comes from Simon Baker from Redburn.
Good morning, everyone. Thank you for taking my questions. Two if I may please firstly on blend.
Obviously, it's just been announced and it can also included a total of yellow or red.
The license fee. The early feedback that you've had you talked about the <unk>.
And clearly we continuously mentioned.
Pumps to the Rems program could you just update us on how we should be thinking about the launch trajectory for <unk>.
To support LBJ to build and continue to build the pipeline alright. Thanks. John next question. Please. Thanks guys. Our next question comes from Simon Baker from Redburn.
And then secondly, slightly bigger picture question for you Luke.
Brain Administration. So the addressable market for Q for q2m is about 15% of patients. When we get to 4, we get to 30% of patients. And then you've got with q6 semi treatment, 50% of patients, who would be very willing to take a long acting injectable, that is a big chunk of the market, which is why we are so excited about the offering that q6 and in treatment, and in prep. But particularly in treatment will offer. Thanks, Deborah. Um, Julie, quick, answer on the on the 40. I think everyone knows, but let's confirm it. Yeah, sure. Thanks, James for the question. So, in terms of what we've included of the recent deal or RX is included epos Furman together with, um, the earlier stage and gooey license PD, 34 reps. Obviously has just been announced, so it's not to include it at all in the lrf.
You mentioned some of the assets of your strategy I was just wondering if you could give us a bit more detail on.
Good morning, everyone and thank you for taking my questions. Two if I may please firstly on blend.
How and in what people when we could learn more about that structure over the course of the year was just something where there will be additional disclosure as we go through the quarterly.
Um, and clearly we continue, as Luke mentioned, um, to support our BD to build and continue to build the pipeline. Great, thanks, Julie.
In the life of the the early feedback that you've had you talked about the.
Next question, please. Thanks. J. Next question comes from Simon Baker from Redbarn. Hi, Simon.
Our response to the Rems program can you just update us on how we should be thinking about the launch trajectory.
Cause or are you envisaging, having capital market stay similar events to lay out the.
Blend right.
The strategy in that sort of all in thanks, so much.
And then secondly, slightly bigger picture question for you Luke.
Thanks, Simon I'll come to later in the second half I think.
You did mentioned some of the assets of your strategy I was just wondering if you could give us a bit more detail on how and in what we call. When we could learn more about that strategy over the course of the year was just something where there will be additional disclosure as we go through the quarterly call.
As I said earlier and thanks for your questions.
Look what you'll get from US is a very clear communication. If it's on track you'll hear about that does not have called it out.
And I really want to use these forums to.
Good morning everyone. Thank you for taking my questions. Uh, to if I may please firstly on blenrep, um, in light of the, the early feedback that you've had, you talked about the, um, uh, response to the. Can you just update us on how we should be thinking about the launch trajectory for blender? Uh, and then, secondly, slightly bigger picture question for For You. Luke, um, you, you did mention some of the
Or are you envisaging, having capital market stay with similar events to lay out the.
Our regular update on our progress.
Where are we going to so I think these are very attractive for them to do it.
The strategy and that sort of forward. Thanks, so much.
And we'll see how that.
Thanks, Simon I'll come to later in our second half I think.
Evolves all the time.
I mean again as I said in my intro Nader and I worked together a long time since huge experience in oncology.
As I said earlier and thank you for your questions.
Look what you'll get from US is a very clear communication.
Responsible for the whole portfolio in partnership with tiny.
Trac you hear about that does not we'll call it out.
Facets of your stress—I just wonder if you could give us a bit more detail on that. We're going to learn more about that strategy for you. Is there something where there will be additional disclosures as we go through the quarterly calls, or are you envisioning having Capital Markets Days or similar events to lay out the strategy in that sort of form? Thanks so much.
And I really want to use these forums to regular update on our progress.
And also we've had a number of other members joined the team.
I've been in their roles during this commercial transformation.
Where are we going to so I think these are very effective for them to do it.
There's a lot of history with those individuals ventas and Roche and Astrazeneca.
And we'll see how that evolves over time.
Thanks, Simon. I'll—I’ll come to Nina in a second. I mean, I think, um, as I said earlier, and thanks for your questions, um, look, what you'll get from us is very clear communication. If it's on track, you’ll hear about it. If it’s not, we’ll call it out.
I mean again as I said in my intro Nader and I have worked together a long time since huge experience in oncology.
People that many of you will know and I've got a very strong record.
And the iron, but bringing them into the team again is just too.
Responsible for the whole portfolio in partnership with tiny.
The rebalance and increase their focus on the portfolio the pipeline and product execution.
And also we've had a number of other members joined the team that.
With that intro Dana I'll give you on blend right in terms of launch uptake in initial initial feedback.
I've been in their roles during this commercial transformation.
There's a lot of his treatment those individuals' ventas and Roche and Astrazeneca.
Yeah. Thank you just checking you can hear me.
Astrazeneca side.
Yeah, great yet so you're the man.
People that many of you will know and I've got a very strong record.
Um, and I really want to use these forums to regularly update on our progress and, um, where we're going to. So I think these are a very effective forum to do it. Um, and we'll see how that evolves over time. Um, Nina—I mean, again, as I said in my intro, I mean Nina and I have worked together a long time, huge experience in oncology, um, and is now responsible for the whole portfolio in partnership with Tony. Um, and also, we've had a number of other members join the team that, um, have been in their roles.
Blender pause and launched in the U S. Just at the end of November. So there are not many and we can't really share a significant update based on the sales numbers, but what we do know we launched in the U K middle of the year and the dynamic is.
And the item, but bringing them into the team again is just too.
A rebalance and increase their focus on the portfolio the pipeline and product execution, so with that and try to Dana overview on blend right in terms of launch uptake in initial initial feedback.
During this commercial transformation, um, and there's a lot of, you know, history with those individuals at Aventis and, uh, Roche and AstraZeneca. So the people that many of you will know, and they've got a very strong record.
Um, and the aim of bringing them into the team again is just to
Yeah. Thank you just checking you can hear me.
Opening the accounts is a systematic it's happening but it is definitely slower because of the coordination of care with eye care professionals.
Yeah, great yet finding so you remember blender was launched in the U S. Just at the end of November So there are not many.
Rebalance and increase the focus on the portfolio of the pipeline and product.
By now we have about 70% of patients covered in the accounts that are open in the U K and based on the uptake. There. We are actually extremely satisfied two things. There is huge interest to cry blended and then we know that we have done good.
And the country is sure a significant update based on the sales numbers, but what do we do now we launched in the U K middle of the year.
Execution. So with that intro, Nina, over to you on Blender in terms of launch uptake and initial feedback. Uh, yeah, thank you. Just checking you can hear me.
And dynamic is.
Opening the pounds is a systematic it's happening, but it is definitely slower because of the coordination of care with eye care professionals.
<unk> in a guiding physicians how to use the drug.
By now we.
Physicians are very much aware of the mood of extended dosing intervals to reduced to reduce or to avoid I related side effects now translating back to the U S and we expect similar dynamics. So the timing of opening the accounts is going to it's going to take time.
We had about 70% of patients covered then get counted that are open in the U K and based on the uptake. There. We are actually extremely satisfied two things. There is huge interest decline blended and then we know that we have done good homework in them.
Yeah, great. Um, yeah, Simon. So, um, you remember Blender was launched in the US just at the end of November, so there are not many—um, we can't really share significant updates based on the sales numbers. But what we do know is, we launched in the UK, um, middle of the year, uh, and, uh, the dynamic is, um, opening the accounts is, uh, systematic. It's happening, but it is definitely slower because of the coordination of care with eye care professionals.
A bit of time longer probably than what you would see Wade and that does conclude that coordination of care, but what we did learn from the first launch is an example, I think I mentioned, we are actively educating 18000 eye care professionals.
Guiding physicians how to use the drug.
Physicians are very much aware of the mood of extended dosing intervals to reduced to reduce or to avoid I would like to find text now translating back to the U S.
Similar dynamic so the timing of opening the accounts is going to is going to take a.
As an illustration comparing to the first launch of blend Greg.
<unk> had only about five to 6000 eyecare professionals engaged in our program.
But the pie longer probably than what you would see Wade and that does conclude that coordination of care, but what we did learn from the first launch is an example, I think I mentioned, we are actively educating 18000 eye care professionals.
By now, we have about 70% of patients, covered in the accounts that are open in the UK and uh, based on the, uh, uptake there, we are actually extremely satisfied. Um, 2 things there is huge interest to try blender. And then, um, we know that that we have done good, good homework in, um, uh, guiding Physicians, how to use the drug? Uh, Physicians are very much aware of the need of extended, uh, dosing intervals to reduce or to reduce or or to avoid. Um, I related side effects now
Helping pizza.
Pete the patients.
Rents has been a big factor I think that to eat has been received very positively currently run this is not an issue.
As an illustration I'm comparing to the first launch of blend Greg.
Our physicians are very much used rental programs and blend reference.
We had only about five to 6000, a eye care professionals engaged in our program.
Very similar.
I kept professionals scale as well.
Said, we are going to reach them are.
Helping teachers to treat the patients.
A significantly higher number and then.
Communicating to the physicians how to use the drug that extended don't think is very relevant to enable early positive experience and I would say that's what we see so far to your question what can we expect.
Rents has been a big factor I think that to eat has been received very positively currently run this is not an issue.
Physicians are very much used rental programs and blend reference.
What we said before it is not going to be a quick ramp up is going to be a slow ramp up but the positive initial experience is more relevant than star Trek. My number of patients very early and then having a negative experience.
Very similar.
I kept professionals scale.
As we said we are going to reach a significantly higher number and then.
Communicating to the physicians how to use the drug that extended don't think is very relevant to enable early positive experience and I would say that's what we see so far to your question what can we expect what.
Thanks, Dana and I would just add one other interesting.
Data point is if we look at usage right now for <unk>, It's about 50 50 between academic and community, which.
What we said before it is not going to be a quick ramp up is going to be a slow ramp up but the positive initial experience is more relevant than star Trek. My number of patients very early and then having a negative experience.
Our strategy is to focus on the community.
With a product that is being relaunched and.
Not a lot of experience in the community I think this is an encouraging trajectory because at this point you would expect volume to be dominated by the academic centers, who tend to move on newer things earlier, but we can say to dana's point the strategy of focusing on the community building confidence supporting onto does the first five patients.
Okay.
Thanks, Dana and I would just add one other interesting.
Data point is if we look at usage right now for <unk>, It's about 50 50 between academic and community, which.
000. Um uh I Care Professionals engaged in in our program. Um, helping treaters to uh, treat the patients. Um, rents has been, um, big factor. I think, you know that it has been, uh, received very positively, uh, currently Rams is not an issue. Uh, Physicians are very much used to Rems programs and, uh, blend reps is, is um, very similar, uh, I Care Professionals scale as, as we said, we are going to reach, um, uh, significantly higher number, and then um, uh, communicating to the Physicians. How to use the drugs that extended dosing is very relevant to enable early positive experience and I would say, that's what we see. So far to your question, what can be expected? Um, what we said before it is not going to be a quick ramp up its going to be a slow ramp up but the positive initial experience is more relevant than connecting High number of patients very early and then having
a negative experience.
<unk> appears to be trying.
Our strategy is to focus on the community.
Try and promise and we will give you a lot more granularity at the Q1 update including on et cetera.
Thanks, Nina, and I would just add one other interesting—um,
With a product that is being relaunched.
uh,
Not a lot of experience in the community I think this is an encouraging trajectory because at this point you would expect volume to be dominated by the academic centers, who tend to move on newer things earlier, but we can say <unk> point the strategy of focusing on the community building confidence supporting them to dose the first five patients.
Thanks, Simon I appreciate the questions next place.
Sure cultural Michael Leuschner from Jefferies.
Thank you for taking the questions hi, Thank you for taking the questions two plays one for Luke.
Been reported that there was a reduction in R&D stuff I think about 350 people in the U S and also in the U K. Just wondering is that part of a broader program normal attrition just wonder if you could put that into context.
Appears to be try and promise and we will give you a lot more granularity at the Q1 update including on et cetera.
Blender. It's about 50/50 between academics and community which, you know, our strategy is to focus on the community and with the product that is being relaunched, uh, and not a lot of experience in the community. I think this is encouraging because at this point, you'd expect volume to be dominated by the—
Thanks, Simon I appreciate the questions next place.
Question comes from Michael <unk> from Jefferies.
Back to Nina on extensor.
A few ways one could launch a product like this especially early on to go into treatment experienced patients, where I guess it would be easier to make an argument to get patients on drug more quickly or internet naive population to broaden out the market can you talk a lot about a little bit of the launch curve for 2026. So how should we think about this as year progresses. Thank you.
Thank you for taking my question Hi.
Academic centers, who tend to move on newer things earlier, but we can see Caninos point the strategy of focusing on the community, building conference supporting them to those—the first 5 patients—appears to be showing promise. And we will give you a lot more granularity at the Q1 update, including on Accenture.
Thanks for taking the questions. Two plays one for Luke it's been reported that there was a reduction in R&D stuff I think about 350 people in the U S and also in the U K. Just wondering is that part of a broader program normal attrition just wonder if you could put that into context.
Um, thanks, Simon. Appreciate the questions. Next, please. Next question comes from Michael Lewis from Jefferies.
And then back to Nina on extensor.
Thanks, Michael So I'll cover the first one I mean, we're going to manage the business.
There's a few ways one could launch a product like this especially early on sort of go into treatment experienced patients, where I guess it would be easier to make.
And.
Well, we success save success will reinforce it.
And to get patients on drug more quickly or internet naive population to broaden out the market can you talk a lot about a little bit of the launch curve for 2026. So how should we think about this as year progresses. Thank you.
We have programs that are less promising.
And Nina and managing the portfolio I've decided to call. Something then we are going to be very dynamic and ship results was behind to where we can get the best return generate assets for the most compelling and ultimately in doing this we will happy shareholders at the end of the process on.
Thanks, Michael So I'll cover the first one.
You're going to manage the business and.
Well, we successfully success will reinforce that.
This is very much this element of accelerating R&D and simplifying how we work.
Thank, thank you for taking the questions. Thank you for taking the questions to please 1 for Luke. Um, it's been reported. That there is a reduction in R&D stuff I think about 350 people in the US. And also, in, in the UK just wondering, is that part of a broader program? Normal, attrition just wonder if you could put that into context and I'm back to Nina on, uh, extensor. Um, this, there's a few ways 1 could launch a product like this, especially early on sort of go into treatment experience patients where I guess it'd be easier to make an argument to get patients on drug more quickly or Internet naive population to broaden out the market. Can you talk a lot about a little bit of the launch curve for 2026? So how should we think about this? Um, as to your progresses? Thank you.
We have programs that are less promising.
And youll see more of that what we can assure you is that we will run the business with great discipline, and where we can see an opportunity we will rapidly move resources people head count capital to support that.
Brian and Neenah, and managing the portfolio I've decided to call. Something then we are going to be very dynamic and shippers also is behind to where we can get the best return generating assets are the most compelling and ultimately in doing this we will have happy shareholders at the end of the process. So this is very much this element of accelerating R&D.
Mena Accenture, yes.
Yes, I can I can I can take that thank you Michael and just as a reminder, Michael and I think this information basically guy Guy to the strategy, we have about mid twenties bio pen in bio penetration in severe asthma. So about 20, 25% of eligible patients now receive biologics.
And simplifying how we work.
And youll see more of that what we can assure you is that we will run the business with great discipline, and where we can see in Australia, we will rapidly move resources people head count capital to support that.
And adults could start some biologics, 65% will discontinue in the first 12 months and that tells you. If we would go for switch active switch that business would be plus very long because patients are dropping anyway.
Mena Accenture, yes.
Yes, I can I can I can take that thank you Michael and just as a reminder, Michael and I think this information basically guy Guy to the strategy, we have about mid twenties bio pen in bio penetration in severe asthma. So about 20, 25% of eligible patients now receive biologics.
And I think we need to look at it in that context. Our main objective I think Luc mentioned that and when we talk about our sales force is going for bio naive patients.
Thanks, Michael. Um, so I'll, I'll cover the first one. I mean, we're going to manage the business and, um, where we successfully succeed, success will reinforce it. Um, if we have programs that are less promising or, um, apparently in need—in managing the portfolio, decide to cull something—then we're going to be very dynamic and shift resources behind to where we can get the best return, generate assets that are most compelling, and ultimately, in doing this, um, we will have happy shareholders at the end of the process. So this is very much the element of accelerating R&D and simplifying how we work. Um, and you'll see more of that. Um, what we can assure you is that we will run the business with great discipline, and where we can see an opportunity, we will rapidly move resources—people, headcount, capital—to support that. Um, Nina? Yeah, extension, yes? Um, yes. Yeah, I can, I can, I can take that. Thank you, Michael. Um, just as a reminder, Michael and I think,
And adults could start some biologics, 65% will discontinue in the first 12 months and that tells you. If we would go for switch active switch that business would be last very long because patients are dropping anyway.
It is very legitimate to expect there will be some switching and they will be switching very likely from the collar hopefully also from other AG.
Agents in severe asthma as well what is more relevant is can extend term gain share from Ah patients who would have otherwise started on other other agents and.
And I think we need to look at it in that context. Our main objective I think Luc mentioned that and when we talk about our sales force.
Four bio naive patients.
Six months I don't think I think you have seen everything that we have seen for both physicians and patients is that there is huge level of enthusiasm for our long acting six monthly dosing and that will hopefully translate into preferential use of expenditure over other agents to initiate patients, but then also.
This information is basically to guide guides of the strategy. We have about mid-20s, biopen in biop, penetration in severe asthma—so about 20-25% of eligible patients now receive biologics, any. And of those who start on biologics, 65% will discontinue in the first 12 months. And that tells you, if we would go for switch, active switch, that business wouldn't last very long because patients are dropping anyway.
It's very legitimate to expect there will be some switching and there would be switching very likely from the collar hopefully also from other.
Agents in severe asthma as well what is more relevant is can accenture gain share from Ah patients Copel would have otherwise started on other other agents and.
Um, and I think we need to look at it in that context—our main objective. I think Luke mentioned that. Um, uh, when we talk about our sales force, it is going for bio-naive patients.
To start patients, who otherwise wouldn't start on biologic yet.
Six months I don't think I think you have seen.
Alright, Thanks, Nina and I think.
But we have to keep for both physicians and patients is that there is huge level of enthusiasm for our long acting six monthly dosing and that will hopefully translate into preferential use of accenture over other agents to initiate patients. But then also to start patients who otherwise wouldn't.
The positioning as the person antibody logic, but delivers ultra loan protection and.
Two does something that's landing extremely well when we look at market research and perception.
Thanks, Michael next question. Please next question cultural Sachin Jain from Bank of America.
Brian.
Yeah.
Charts on biologic yet.
Alright, Thanks, Nina and I think the positioning as the personalities.
Hi, Matt sorry about that can you hear me now.
Yes, we can thanks perfect. Thanks, a couple of questions. Please just.
Ultra loan prepayment protection.
And two does that's lending extremely well when we look at market research and perception.
Firstly can meet our and congrats when euro.
It's a bit more detail on how many physicians have you have through the Rems certification process and any cadence of how you think that will go through the year as are the rate limiting factor.
Develop enthusiasm for uh long-acting 6, monthly dosing, and that will hopefully translate into preferential use of Extension over other agents to initiate patients. But then also to start patients who otherwise wouldn't start on biologic yet.
Buckled next quiet place next question cultural Sachin Jain from Bank of America.
Okay.
Second one for Deborah on the HIV event media clearly, we're looking to QC, Samsung, but I wonder if you would be disclosing how you think about the financials of our business through the <unk> and I guess two questions. One how do you think about the rate of decline in this business relative to where consensus sits.
Yeah.
Hi, Matt sorry about that can you hear me now.
Perfect. Thanks, a couple of questions.
Great. Thanks. And I think the, the positioning is the person only biologic that delivers Ultra long protection. Uh, in 2 doses here that's Landing extremely well, when we look at market research and perception. Um, thanks Michael next question, please. Next question comes from s, Jane from Bank of America, my session.
We can meet or anything around when euro are perhaps a bit more detail on how many physicians have you have through the rems certification process and any cadence of how you think that will go through the year as are the rate limiting factor.
<unk> is in the mid term guidance, how would you plan on including at that point. If you saw on the phase III and then a quick one for you.
Hi, sorry about that.
Secondly, with a debra on the HIV event media clearly, we're looking to Houston.
We can, thanks—perfect, thanks. A couple of questions, please. Just, um, first, do you need anything or anything around for the new role?
Just on your slide five and high level objectives, you've mentioned two things one.
Vacation do you intend to have any official cost savings program and then secondly, R&D acceleration are there any specific programs that you can target Readouts will finally, thank you.
I Wonder if you would be disclosing how you think about the financials of that business through the MLP and I guess two questions. One how do you think.
Perhaps a bit more detail on Blain rep. How many physicians have you had through the REM certification process?
About the rate of decline in this business relative to where consensus is and I guess two 6%.
Thanks, Sachin to I'll answer your last question and then we'll go into Debra and then finish with Dana.
The midterm guidance, how would you plan on including at that point, if you're starting to phase III.
I mean, we're always looking to say about it because.
And then a quick one for you just on your slide five and high level objectives, you've mentioned two things one.
I think it's always an opportunity cost right. So.
And of how you think that will go through the year as a as a rate limiting factor. Um second 1 for Deborah, on the HIV event media. Clearly we're looking to um cue 6m start but I wonder if you will be disclosing. How you think about the financials of that business through the LOE? And I guess, few questions 1, how do you think about, um, the rate of decline of this business relative to work consensus? It's
If we can move resources behind particular assets, where we think there is a hostile.
Simplification do you intend to have any official cost savings program and then secondly, R&D acceleration are there any specific programs that you can target Readouts will finally, thank you.
Richard and I had the clinical profile adjusted justify then we will do that and we won't continue that dynamic in disciplined fashion areas for acceleration I can't I think naturally the scale of December 9th straight by raises quite interesting I think Friday 47 inch pool. It is a very competitive and dynamic area.
Thanks session. So I'll answer the last question that will go into Debra and then finish with Dana.
I mean, we are always looking too excited about it because.
Well I think it's always an opportunity cost rock.
But I think we're starting to see some color around the tox profile that could give us an edge.
We can move resources behind particular assets, where we think there is a hostile and return.
J F. 'twenty one we looked at all three of those companies. We think we've bought the best again, you'd expect me to say that but I think we come back up in time with the protocols of the frequency of the dosing and some of the.
I had the clinical profile adjusted justify then we will do that and we won't continue that dynamic and disciplined fashion areas for acceleration.
Jan I think naturally the scale of the semi industry raises quite interesting I think Friday. All these have an H score. It is a very competitive and dynamic area, but I think we're starting to see some color around the tox profile that could give us an edge.
The protocol of the product all the time.
So they're probably the key ones tittsworth as well long acting thanks Luke.
Again, the target is being actively de risked.
By Astrazeneca.
And if we have a plan.
FGF 21, we looked at all three of those companies. We think we have the best again, you'd expect me to say that but I think we can back up in time with the protocol of the frequency of the dosing and some of the.
It forwards and rapidly because it is.
My guess q6 m isn't in uh, the midterm guide. So if you plan on, including it at that point, if you start the phase 3 and then a quick 1 for you Loop, just on your slide 5 and high level objectives. Uh you you've mentioned 2, things 1 Simplicity? Do you intend to have any official cost Savings Program and then secondly R&D acceleration, are there any specific programs that you can Target for earlier readouts or filing? Thank you. Thanks session to all out to your last question. Then we'll go to Deborah and then finish with Nina. Um, I mean, we are always looking to save money because you know, I I think it's always an opportunity cost, right? So if we can move resources behind particular assets, where we think there is a higher payoff and return and they have the clinical profile of just justify it, then we will do that. And we will continue that, you know, dynamic and disciplined fashion areas for acceleration. Uh, again I think naturally the scale of B7 H3 by rezz is quite interesting. I think, uh, 5844 B7 H4. It
Long acting can really reframe the name is early appointment.
The protocol of the product and all of that in time.
They're probably the key ones take Swift bodes well long acting thanks Luke.
Again, the target is being actively derisked by Astrazeneca.
And I think that we have a plan to move that asset forward and rapidly because it is a very attractive area we think.
Long acting can really reframe. The name is earlier point about how average broker diseases are treated.
Is a very competitive and dynamic area, but, you know, I think we're starting to see some color around the top profile. That could give us an edge, um, fgf21. We looked at all 3 of those companies, we think we've bought the best again. You'd expect me to say that, but I think we can bounce in time with the profile of the frequency of the dosing and some of the the the the the profile of the product that will emerge in time. Um, so they're probably the key ones teeth slip as well. Long acting piece lifts. Uh again, you know, the target is being actively de-risked.
Deborah.
By Astrozen, um, and I think that we have a plan to move that asset.
Thank you Scott for the question.
So.
If we think about.
These six M. First so we are intending to set tops that HIV story in the middle of the year.
We wouldn't treat in a regimen selection and we then commence with phase two we will put that into our long range forecast switches.
Forwards and rapidly because it is a very attractive area. We think, you know, long-acting can really reframe Sena's earlier point about how respiratory diseases are treated. Um, Deborah, over to you on HIV—brilliant. Thank you, Sachin, for the question. Um, so
if we think about,
We always operate with.
Critics get to that space.
That face to face so you'll.
You'll see that happen midyear.
He then asked about the evolution of the kind of the portfolio at the time. So let me just give you a top line view and we will come back and talk more about this when we set out.
The $6 million. First, so we are intending to, um, set out our HIV story in the middle of the year, and at that point, once we've done, we then commence with Phase 2. We will put that into our long-range forecast, which is—
HIV emulation in the middle of the so we've seen a relatively rapid decline I'll try in that because the guidelines have moved away from traffic and what's happened is over the last 12 months, it's crazy dynamism in the market.
How we always operate when, um, products get to that phase through, uh, to that Phase 2 phase. So, um, you'll see that happen mid-year.
Vodka was benefited significantly as have in Asia.
The amount that sitting and trying to continue the case you can see it's coming down quite significantly in advance of the loss of exclusivity of dollar type of it which is to remind you a glide path to cliffs starting in April 28 in the U S. And then July 29 in Europe.
You then asked about the evolution of the kind of the portfolio over time. So let me just give you a topline view, and we will come back and talk more about this when we set out the HIV evolution in the middle of the year. So, we've seen a relatively rapid decline of priors. The guidelines have moved away from Triac, and what's happened is over the last 12 months.
With obviously cavaco into literally with U S. Having intellectual property coverage now until towards the end of 'twenty nine.
And July 20, <unk>, so the glide pass coming down we're already seeing a move away from the old on the takeaway regimens into a newer regimen and that is going to continue and then what's going to happen is we will continue to power forward with companies that Q2, and it's doing incredibly well growing fast which it has not.
Been dented by the loan Trump yesterday said that were also continued to grow 26 and beyond and then what we will see is Q4 and both treatments coming in empowering longer acting forward again until we reach the point at which we launched to fix them and then we've got two brand new molecules with intellectual property.
Coverage composition of matter patent stream into the 2014.
So you see a dip in 29 and 30 for the franchise as we facing the largest erosion through the exclusivity loss and then we come back how can you break in 2021 and beyond and that growth in that decade is gonna be a significant contributor to GSK success in the 'twenty for that is because we are incredibly cool.
And the value to patients the acoustics will bring.
If you know, but that hopefully gives you a sort of a view as to how it's going to evolve we will share more details in the middle of a yeah I just want everybody to understand that HIV it won't be a big contributor to that.
Continue. And then what's going to happen is we will continue to power forward with kabanova, q2m, it's doing incredibly well growing fast. Aptitude has not been dented by the launch of years to go, so that will also continue to grow 26 and Beyond. And then what we will see, is Q4 em both treatments and prep coming in and powering longer acting forward again until we reach the point at which we launched q6 M, and then, we've got 2 brand new molecules with intellectual property, uh, coverage, composition of matter, patent through into the 2014. And so, you see a dip in 29 and 30 for the franchise, as we face into the largest erosion, through the exclusivity loss, and then we come back out into breaking 2031 and Beyond, and that growth in that decade, is going to be a significant contributor to GSK success in the 2030s because we are incredibly confident in the value to patients that the q6 M will bring. So,
GSA success, this decade and into the future right. Thanks Debra.
And then we're trying to squeeze one more question because yes definitely.
Sachin. Thank you first of all are trying to avoid the situation where even chase in the next quarter for the same number rents are hungry.
Hundreds and albeit that's a that's just a fact.
Yeah.
Happy about where we're at.
If, you know, if—if that—that hopefully gives you a, a sort of a view as to how it's going to evolve, we will share more detail in the middle of the year, but I just want everybody to understand that HIV will be a big contributor to GSK success this decade and into the future, right? Thanks. So, a quick answer and then we'll try and squeeze one more question. Yeah, definitely. As fashion—thank you. First of all, trying to avoid the situation where you will chase me in the next quarter for the same number.
One more question, we have time for that central what LOE question. Thanks.
Uh rents, uh, hundreds.
Next question comes from Steve Scala at Cowen.
Hundreds, and, uh, obviously that's—that's just a start.
Good morning, David Good morning. Thank you. So much two questions first one camera pixel if GSK needs two positive trials to file which is what the company has said previously then what's the purpose of the pooled analysis <unk> has FDA confirmed it will accept the filing based on pool data, even if one trial.
Yeah, I mean, we feel happy about where we're at. Um, one more question—we have time for that. Yeah, for one more question. Next question comes from Steve Skylar, TD.
Morning. Steve.
A negative and secondly on Shin grips, what were sales to GSA in Q4, and what is your level of confidence in 26 on the on the stroke.
Sure Tony you want to cover correctly, Steve Hi, not going to get into details of regulatory strategy, but as you defined it.
It's giving us the option to take the approach both as independent and ultimately who studied as Trevor talked about saying that we remain confident in the outcomes to both com Walmart com too.
Good morning, thank you so much. Um, two questions, first on Camarija, Pixan. If GSK needs two positive trials to file, which is what the company has said previously, then what's the purpose of the pooled analysis? And/or has FDA confirmed it will accept filing based on pooled data, even if one trial—what were sales to GFA in Q4, and what is your level of confidence in 2026 on this, on this track?
Steve There was a shipment in December.
You can get you that number offline and I have a couple of what I will say.
Is that the underlying underlying demand is improving in China.
Sure, Tony. You want to cover quickly. Hey Steve, um, hi. I'm not going to get into details of regulatory strategy, but as you defined, what it's giving us is the option to take the approach both as independent and ultimately approved studies. However, throughout saying that, we remain confident in the outcomes for both CAM 1 and CAM 2.
Up six times since the start of 2025 now it's a low base and we are.
Grown the market share, but this is Jon Weiss. So now we have 93% market share.
In that population, which is an operational improvement.
And what is driving this we've shifted the strategy to the one that we launched in Australia.
That's all.
Also a drug in Germany, and now we are applying in the U S, which is also helping us.
Get some traction there.
Really just told me, it's 100 billion, we did at the end of last year. So there's still some stock on the pod, but again, we'll give you more color on Q in Q1, but it's heading in the right direction, along with <unk> and aggregate charter.
I think we'll stop there because I know a lot of your day to join another call and I want to respect that.
Thank you again.
Investing the time to construct some thoughtful questions and joining the call and your interest in the company and we look forward to updating you further next quarter. Thank you.
Yeah, it's Dave, I there was a shipment in December. Um, we can get you that number offline. I don't have the top of my head, what I will say, um, is that the underlying underlying demand in improving in China? So it's up 6 of 2025. Now, it's a low base, um, and we've grown the market, share versus gwei. So now we have 93% market share, uh, in that population which is, you know, an operational Improvement. Um, and what is driving this? We've shifted the strategy to the 1 that we launched in Australia. And um, also uh, drove in Germany. And now, we're employing in the US, which is also helping us, um, get some traction there. Um, Julie just told me it's a 100 million we did at the end of the last last year, so there's still some stock in the pipe, but again, we'll give you more color and Q q1, but it's heading in the right direction, along with shingrix in aggregate. So I think we'll stop there because I know a lot of you need to join another call and I want to respect that. Um, thank you again.
Thank you for, um, investing the time to, uh, construct such thoughtful questions and join in the call. We appreciate your interest in the company, and we look forward to updating you further next quarter. Thank you.
