REG - GSK PLC - 1st Quarter Results
Wed 07:00
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RNS Number : 7053G GSK PLC 30 April 2025
GSK makes strong start to 2025 with growth in sales, profits and earnings
Specialty Medicines growth drives Q1 performance
• Total Q1 sales £7.5 billion +2% AER; +4% CER
• Specialty Medicines sales £2.9 billion (+17%); Respiratory, Immunology and
Inflammation £0.8 billion (+28%); Oncology £0.4 billion (+53%); HIV sales
£1.7 billion (+7%)
• Vaccines sales £2.1 billion (-6%); Shingrix £0.9 billion (-7%); Meningitis
vaccines £0.4 billion (+20%); and Arexvy £0.1 billion (-57%)
• General Medicines sales £2.5 billion (stable); Trelegy £0.7 billion (+15%)
• Total operating profit +50% and Total EPS +56% driven by lower CCL charges
• Core operating profit +5% and Core EPS +5% reflecting strong Specialty
Medicines performance and disciplined increased investment in R&D
portfolio progression, new asset launches and growth assets
• Cash generated from operations exceeded £1 billion with free cash flow of
£0.7 billion
(Financial Performance - Q1 2025 results unless otherwise stated, growth % and
commentary at CER as defined on page 44).
Q1 2025
£m % AER % CER
Turnover 7,516 2 4
Total operating profit 2,216 49 50
Total operating margin % 29.5% 9.2ppts 9.0ppts
Total EPS 39.7p 55 56
Core operating profit 2,533 4 5
Core operating margin % 33.7% 0.5ppts 0.3ppts
Core EPS 44.9p 4 5
Cash generated from operations 1,301 16
Pipeline progress and investment delivering future growth opportunities:
5 major new FDA product approvals expected in 2025:
• Q1 2025 approvals: Penmenvy, meningitis vaccine; Blujepa, first-in-class
antibiotic treatment for uUTIs
• Positive ACIP recommendations for Penmenvy (and Arexvy (adults 50-59))
• Further approvals expected for: Nucala (COPD); Blenrep (multiple myeloma); and
depemokimab (severe asthma and nasal polyps)
14 key opportunities expected to launch 2025-2031 each with PYS potential
above £2 billion
• Data presented at CROI for VH184, VH499 and N6LS support development plans for
ULA HIV regimens
• Breakthrough designation granted for GSK'227 B7H3 ADC for 2L osteosarcoma
• Pivotal/Phase III trials expected to start in 2025 for: Respiratory
(depemokimab COPD programme - ENDURA); Oncology (GSK'227 B7H3 ADC ES-SCLC;
IDRx-42 2L GIST; Ojjaara (MDS)); and HIV (Q4M treatment)
Investment in targeted business development continues
• Acquisition of IDRx completed
• New partnership with ABL Bio in neurodegenerative diseases; and novel research
collaboration with UK Dementia Research Institute & HDRUK to investigate
shingles vaccination with prevention of dementia
Continued commitment to shareholder returns
• Dividend declared of 16p for Q1 2025; 64p expected for full year 2025
• £273 million of shares bought back as part of the £2 billion share buyback
programme commenced in Q1 2025
Confident for delivery of 2025 guidance
• Continue to expect 2025 turnover growth 3% to 5%; Core operating profit growth
6% to 8%; Core EPS growth 6% to 8%
Guidance all at CER
Emma Walmsley, Chief Executive Officer, GSK:
"GSK continues to make strong progress, demonstrating the quality, strength
and resilience of our portfolio. Specialty Medicines, our largest business,
delivered strong sales contributions in the quarter and R&D progress
continued, with two of the five FDA product approvals expected this year now
secured, and the acquisition of a promising new oncology asset. We are very
focused on preparing for launches of Blenrep, Nucala and depemokimab, and
pivotal trials for potential new medicines in respiratory, oncology, HIV and
hepatitis. This momentum, together with the strength of our portfolio and
proven ability to drive operating leverage, underpin our confidence in
guidance for the year and our longer-term outlooks."
The Total results are presented in summary above and on page 7 and Core
results reconciliations are presented on pages 19 and 20. Core results are a
non-IFRS measure that may be considered in addition to, but not as a
substitute for, or superior to, information presented in accordance with IFRS.
The following terms are defined on pages 44-45: Core results, AER% growth,
CER% growth, turnover; and other non-IFRS measures. GSK provides guidance on a
Core results basis only for the reasons set out on page 17. All expectations,
guidance and targets regarding future performance and dividend payments should
be read together with 'Guidance and outlooks, assumptions and cautionary
statements' on page 46. Abbreviations are defined on page 50.
2025 Guidance
GSK affirms its full-year 2025 guidance at constant exchange rates (CER).
Turnover is expected to increase between 3 to 5 per cent
Core operating profit is expected to increase between 6 to 8 per cent
Core earnings per share is expected to increase between 6 to 8 per cent
This guidance is supported by the following turnover expectations for
full-year 2025 at CER
Specialty Medicines - expected increase of a low double-digit per cent in turnover
Vaccines - expected decrease of a low single-digit per cent in turnover
General Medicines - expected to be broadly stable for turnover
Core operating profit is expected to grow between 6 to 8 per cent at CER. GSK
expects to deliver leverage at a gross margin level due to improved product
mix from Specialty Medicines growth and continued operational efficiencies. In
addition, GSK anticipates further leverage in Operating profit as we continue
to take a returns-based approach to SG&A investments. Royalty income is
now expected to be higher than previously guided at £750-800 million,
including an IP settlement agreed in April. This additional income will be
reinvested in the pipeline this year.
Core earnings per share is expected to increase between 6 to 8 per cent at
CER, in line with Core operating profit growth, reflecting higher interest
charges and the tax rate which is expected to rise to around 17.5%, offset by
the expected benefit of up to 1% from the share buyback programme.
Expectations for non-controlling interests remain unchanged relative to 2024.
Tariffs
GSK notes that the US Administration has initiated an investigation under
Section 232 of the Trade Expansion Act to determine the effects on national
security of imports of pharmaceutical products. The company is well positioned
to respond to the potential financial impact of sector-specific tariffs,
should they be implemented, with mitigation options identified in the supply
chain and productivity initiatives. The company will continue to monitor and
review developments related to this situation.
Dividend policy
The Dividend policy and the expected pay-out ratio remain unchanged.
Consistent with this, GSK has declared a dividend for Q1 2025 of 16p per
share. GSK's future dividend policy and guidance regarding the expected
dividend pay-out in 2025 are provided on page 31.
GSK has commenced a £2 billion share buyback programme, to be implemented
over the period to the end of Q2 2026.
2021-2026 and 2031 Outlooks
In February 2025 GSK set out improved outlooks for 2031. Please see 2024 full
year and fourth quarter results on gsk.com
(https://www.gsk.com/media/11776/fy-2024-results-announcement.pdf) (1).
Exchange rates
If exchange rates were to hold at the closing rates on 24 April 2025
($1.33/£1, €1.17/£1 and Yen 190/£1) for the rest of 2025, the estimated
impact on 2025 Sterling turnover growth for GSK would be -2% and if exchange
gains or losses were recognised at the same level as in 2024, the estimated
impact on 2025 Sterling Core Operating Profit growth for GSK would be -4%.
Results presentation
A conference call and webcast for investors and analysts of the quarterly
results will be hosted by Emma Walmsley, CEO, at 12 noon BST (US EDT at 07.00
am) on 30 April 2025. Presentation materials will be published on www.gsk.com
prior to the webcast and a transcript of the webcast will be published
subsequently.
Notwithstanding the inclusion of weblinks, information available on the
company's website, or from non GSK sources, is not incorporated by reference
into this Results Announcement.
(1) https://www.gsk.com/media/11776/fy-2024-results-announcement.pdf
(https://www.gsk.com/media/11776/fy-2024-results-announcement.pdf)
Performance: turnover
Turnover Q1 2025
£m Growth Growth
AER% CER%
HIV 1,714 6 7
Respiratory, Immunology and Inflammation 804 26 28
Oncology 415 52 53
Specialty Medicines 2,933 16 17
Shingles 867 (8) (7)
Meningitis 350 17 20
RSV (Arexvy) 78 (57) (57)
Influenza 1 (92) (92)
Established Vaccines 799 (5) (3)
Vaccines 2,095 (8) (6)
Respiratory 1,710 (1) 1
Other General Medicines 778 (7) (3)
General Medicines 2,488 (3) -
Total 7,516 2 4
By Region:
US 3,752 5 4
Europe 1,749 8 11
International 2,015 (6) (2)
Total 7,516 2 4
Financial Performance - Q1 2025 results unless otherwise stated, growth % and
commentary at CER.
Q1 2025
£m AER CER
Specialty Medicines 2,933 16% 17%
Specialty Medicines sales grew by double-digit percentages in the quarter,
reflecting continued growth across disease areas, with strong performances in
HIV, Respiratory, Immunology and Inflammation, and Oncology.
HIV 1,714 6% 7%
HIV sales grew by 7% this quarter with the US growing at 9%. This was driven
by a 9 percentage point increase in patient demand from Cabenuva, Apretude and
Dovato reflecting strong market share growth. Growth in the quarter also
benefited from customer ordering patterns, offset by unfavourable price
impacts from channel mix adjustments and the impact of IRA Medicare Part D
redesign.
Oral 2DR 728 14% 15%
Sales of Oral 2DR now represent 42% of the total HIV portfolio. Dovato, the
first and only once-daily Oral 2DR for the treatment of HIV infection in both
treatment naive and virally suppressed adults and adolescents continues to be
the largest product in the HIV portfolio with sales of £570 million in the
quarter and growing 19%.
Long-Acting 383 43% 43%
Long-Acting sales in the quarter now represent 22% of the total HIV portfolio
(29% in the US) and contributed 100% of the total HIV growth in Q1 2025.
Cabenuva, the only complete long-acting injectable regimen for HIV treatment
reached sales of £294 million in the quarter, growing 38% due to strong
patient demand across US and Europe. Apretude, the first long-acting
injectable option for HIV prevention delivered sales of £89 million in the
quarter, growing 63% compared to Q1 2024.
Respiratory, Immunology and Inflammation 804 26% 28%
Sales primarily comprised contributions from Nucala in respiratory and
Benlysta in immunology. Double-digit sales growth in the quarter was delivered
for both Nucala and Benlysta, driven by patient demand globally across US,
European and International markets. Growth in the quarter was also positively
affected by the impacts of channel inventory reductions in the US in Q1 2024
for both Nucala and Benlysta.
Q1 2025
£m AER CER
Nucala 444 19% 21%
Sales growth in the quarter was driven by strong performance across all
regions, reflecting higher patient demand for treatments addressing
eosinophilic-led disease. Growth in the quarter in the US was predominantly
driven by the impacts of channel inventory reductions occurring in 2024, with
further underlying double digit volume increases being largely offset by
unfavourable price impacts, including the impact of IRA Medicare Part D
redesign.
Benlysta 359 38% 39%
Sales of Benlysta, a monoclonal antibody treatment for lupus, grew in the
quarter representing strong demand and volume growth in US, European and
International regions, with bio-penetration rates having increased across many
markets. Growth in the US was also positively impacted by price favourability,
as well as the impacts of channel inventory reductions that occurred in Q1
2024.
Oncology 415 52% 53%
Oncology sales are largely comprised of sales from Jemperli, Zejula and
Ojjaara/Omjjara. Strong sales growth in the quarter was driven in particular
by increasing patient demand for Jemperli and Ojjaara/Omjjara.
Jemperli 174 >100% >100%
Sales of Jemperli grew strongly in the quarter, driven largely by continued
volume growth in the US following Q3 2024 FDA approval expanding the
indication to include all adult patients with primary advanced or recurrent
endometrial cancer. Europe and International regions increasingly contribute
to sales and growth, with Jemperli now available in over 30 countries
worldwide.
Zejula 131 (7%) (5%)
Sales of Zejula, a PARP inhibitor treatment for ovarian cancer, decreased in
the quarter, driven largely by a double-digit decrease in the US. Performance
in the US was adversely impacted by price unfavourability, driven in part by
ongoing channel pricing pressure, and also from impacts of favourable Q1 2024
comparator channel mix adjustments.
Ojjaara/Omjjara 112 >100% >100%
Sales of Ojjaara/Omjjara, a treatment for myelofibrosis patients with anaemia,
grew strongly in the quarter largely driven by the US with continued patient
uptake and volume growth. Sales in the quarter included increasing
contributions from Europe and International regions, following the recent
launch in Japan in Q3 2024, and with further new launches including Spain and
Italy in Q1 2025.
Vaccines 2,095 (8%) (6%)
Vaccines sales decreased in the quarter, primarily impacted by lower demand
for Arexvy related to a more limited ACIP recommendation combined with lower
demand for Shingrix in the US and International. Meningitis vaccines continued
to show strong demand with double-digit sales growth.
Shingles 867 (8%) (7%)
Sales of Shingrix decreased in the quarter, with lower sales in the US and
International partially offset by growth in Europe.
The US cumulative immunisation rate reached 41%, up five percentage points
compared to 12 months earlier(1). Sales decreased by 21% in the quarter due to
the continuing slowdown in the pace of penetration of harder-to-reach
unvaccinated consumers, as well as higher channel inventory consumption.
Sales of Shingrix decreased in International in the quarter, reflecting a
strong Q1 2024 comparator driven by rapid uptake from the national
immunisation programme in Australia. Performance was also impacted by lower
current quarter supply to our co-promotion partner in China.
In Europe, Shingrix sales grew in the quarter driven by new launch uptake in
France together with expanded public funding and higher private market demand
across several countries.
Shingrix is now launched in 54 countries, with markets outside the US
representing 57% of Q1 2025 global sales (2024: 50%). The overwhelming
majority of ex-US Shingrix opportunity is concentrated in 10 markets where the
average immunisation rate is around 8% with significantly higher uptake in
funded cohorts.
Meningitis 350 17% 20%
In the quarter, both key Meningitis vaccines continued to grow strongly,
achieving double-digit growth. Bexsero, a vaccine against meningitis B, grew
20% primarily driven by continued uptake following the recommendation in
Germany together with the implementation of mandatory newborn vaccination in
France and public funding in Switzerland. Menveo, a vaccine against meningitis
ACWY, grew mainly due to the timing of deliveries in International.
Footnote: (1) Based on data from IQVIA up until the end of Q4 2024
Q1 2025
£m AER CER
RSV (Arexvy) 78 (57%) (57%)
Arexvy sales decreased in the quarter. US sales declined due to lower demand
partly related to a more limited recommendation from ACIP for individuals aged
60 to 74. Arexvy maintained the market leading position in retail where the
overwhelming majority of doses are administered.
Growth in Europe was driven by launch uptake following recommendation and
reimbursement in Germany offset by a decrease in International reflecting
lower demand in Saudi Arabia and Canada. While Arexvy is approved in 66
markets globally, 18 countries had national RSV vaccination recommendations
for older adults and 6, including the US, had reimbursement programmes for
Arexvy in place at the quarter end.
Established Vaccines 799 (5%) (3%)
Established Vaccines sales decreased primarily in International, which was
impacted by 2024 sales of AS03 adjuvant and divested brands as well as
competitive pressure and supply phasing for Cervarix. This was partially
offset by higher orders for MMR vaccines in the US due to measles outbreaks.
General Medicines 2,488 (3%) -%
Sales include contributions from both the Respiratory and Other General
Medicine portfolios. Sales were broadly stable in the quarter at CER, with
strong growth delivered across all regions by Trelegy offset by decreases in
Seretide/Advair, other respiratory and Other General Medicine products. Sales
in the quarter at AER declined driven by exchange movements in a number of
International markets.
Respiratory 1,710 (1%) 1%
Sales grew low single-digit in the quarter, with strong growth delivered
across all regions by Trelegy offset by declines in Seretide/Advair and other
respiratory products. Declines in the quarter for Seretide/Advair and
Flixotide/Flovent included the impacts of adverse inventory movements in the
US compared to Q1 2024. Decreases in the quarter at AER were driven by
exchange movements in a number of International markets.
Trelegy 675 14% 15%
Trelegy sales continued to grow in the quarter, with strong volume growth
continued across all regions reflecting patient demand, SITT class growth, and
increased market share. Specifically in the US, continued strong volume growth
is partially offset by price unfavourability resulting from channel mix and
pricing pressures and the impact of IRA Medicare Part D redesign.
Other General Medicines 778 (7%) (3%)
Other General Medicines sales decrease was driven by continued generic
competition across the portfolio. Decreases in the quarter at AER were driven
by exchange movements in a number of International markets.
By Region
Q1 2025
£m AER CER
US 3,752 5% 4%
Specialty Medicines double-digit sales growth in the quarter was driven by
strong Oncology and HIV performance, and continued growth for Nucala and
Benlysta. The growth of Nucala and Benlysta was positively affected by the
impacts of channel inventory reductions that occurred in Q1 2024.
Vaccines sales decreased in the quarter due to lower demand for both Shingrix
driven by the continued challenge of activating harder-to reach consumers and
Arexvy due to a more limited ACIP recommendation for RSV vaccination.
General Medicines sales low single-digit growth in the quarter was primarily
driven by increased demand for Trelegy, with strong volume growth from higher
patient demand, partially offset by price unfavourability resulting from
continued channel pricing pressures and mix. Strong growth in Trelegy sales
was partially offset by decreases across other general medicine products.
US performance in the quarter reflected the introduction of the IRA Medicare
Part D redesign, which adversely impacted a number of products across
Specialty Medicines, Vaccines and General Medicines.
Europe 1,749 8% 11%
Specialty Medicines sales grew by double-digits in the quarter due to
continued strong performance in Oncology, Benlysta and Nucala including the
benefit from new indication launches. Strong HIV growth continued in the
quarter at a mid-single digit percentage.
Vaccines sales growth was driven by Shingrix new launch uptake in France
together with expanded public funding and higher private market demand across
several countries. Bexsero and Arexvy sales also grew strongly mainly in
Germany following recommendations.
General Medicines sales decreased low single-digit in the quarter, with
double-digit growth for Trelegy and Anoro being more than offset by decreases
across other general medicine products.
International 2,015 (6%) (2%)
Specialty Medicines double-digit sales growth in the quarter was driven by
Nucala in respiratory, Benlysta in immunology, and Oncology. HIV delivered
broadly stable sales in the quarter.
Vaccines sales decreased in the quarter with lower Shingrix sales due to a
strong comparator period which included rapid uptake from the national
immunisation programme in Australia together with lower current quarter supply
to our co-promotion partner in China. Established Vaccines sales were also
negatively impacted by 2024 sales of AS03 adjuvant and divested brands as well
as Cervarix competitive pressure and supply phasing.
General Medicines sales decreased low single-digit in the quarter, with
double-digit growth for Trelegy and Anoro being more than offset by decreases
across other general medicine products.
Financial performance
Total Results Q1 2025
£m % AER % CER
Turnover 7,516 2 4
Cost of sales (1,937) (2) -
Selling, general and administration (2,070) (1) 3
Research and development (1,462) 2 3
Royalty income 180 19 21
Other operating income/(expense) (11)
Operating profit 2,216 49 50
Net finance expense (108) (19) (20)
Profit before taxation 2,108 56 57
Taxation (336)
Tax rate % 15.9%
Profit after taxation 1,772 64 66
Profit attributable to non-controlling interests 148
Profit/(loss) attributable to shareholders 1,624
1,772 64 66
Earnings per share 39.7p 55 56
Financial Performance - Q1 2025 results unless otherwise stated, growth % and
commentary at CER.
Core results
Reconciliations between Total results and Core results Q1 2025 and Q1 2024 are
set out on pages 19 and 20.
Q1 2025
£m % AER % CER
Turnover 7,516 2 4
Cost of sales (1,726) - 1
Selling, general and administration (2,060) 4 8
Research and development (1,377) 1 2
Royalty income 180 19 21
Core operating profit 2,533 4 5
Core profit before taxation 2,432 5 6
Taxation (434) 7 9
Tax rate % 17.8%
Core profit after taxation 1,998 5 6
Core profit attributable to non-controlling interests 162
Core profit attributable to shareholders 1,836
1,998 5 6
Core Earnings per share 44.9p 4 5
Q1 2025
£m AER CER
Cost of sales Total 1,937 (2%) -%
% of sales 25.8% (1.0%) (1.1%)
Core 1,726 -% 1%
% of sales 23.0% (0.6%) (0.7%)
Total and Core cost of sales as a percentage of sales decreased in Q1 2025
primarily driven by mix benefits from growth in Specialty Medicines,
particularly Nucala and Benlysta, and regional margin mix from higher US and
Europe sales.
Q1 2025
£m AER CER
Selling, general & Total 2,070 (1%) 3%
administration
% of sales 27.5% (0.8%) (0.3%)
Core 2,060 4% 8%
% of sales 27.4% 0.5% 1.1%
Total SG&A growth in the quarter was primarily driven by higher Core
SG&A spend, partly offset by lower Significant legal expenses. Q1 2025
Core SG&A growth includes a 4 percentage point impact driven by the Q1
2024 reversal of the legal provision related to the Zejula royalty dispute,
following a successful appeal.
Core SG&A growth in the quarter was driven by disciplined investment to
support the launch of new assets including depemokimab, Penmenvy and Blenrep,
and growth of key assets including Ojjaara/Omjjara, Nucala, and Shingrix, as
well as investment behind long-acting HIV medicines.
Q1 2025
£m AER CER
Research & development Total 1,462 2% 3%
% of sales 19.5% -% (0.2%)
Core 1,377 1% 2%
% of sales 18.3% (0.1%) (0.3%)
In Q1 2025, Total and Core R&D investment increased in the quarter driven
by continued progression across the portfolio.
In Specialty Medicines, investment increased to support late-stage clinical
development programmes for camlipixant, the long acting TSLP asset, and
bepirovirsen. HIV investment increased on next-generation long-acting
treatment and preventative medicines. In Oncology, increased investment
reflects acceleration in work on antibody-drug-conjugates.
In Vaccines, clinical trial programmes associated with the pneumococcal MAPS
and mRNA continued to drive investment.
These increases were partly offset by lower spend on depemokimab, following
filing for severe asthma and CRSwNP indications, and in Blenrep (multiple
myeloma) and Zejula (endometrial cancer) as studies progress to completion.
Q1 2025
£m AER CER
Royalty income Total 180 19% 21%
Core 180 19% 21%
The increase in Total and Core royalty income in Q1 2025 primarily reflected
increases in Kesimpta and Biktarvy royalties.
Q1 2025
£m AER CER
Other operating Total (11) 98% 98%
income/(expense)
Q1 2025 other operating expense included a charge of £2 million (Q1 2024:
£685 million) arising from the remeasurement of contingent consideration
liabilities (CCL) and the liabilities for the Pfizer, Inc. (Pfizer) put
option. The charge in the current quarter primarily reflected discount unwind
as well as changes to sales forecasts, partly offset by favourable foreign
exchange movements. See page 21 for further details.
Other net operating expense at £9m (Q1 2024: £152 million income) reflected
fair value movements on equity instruments, partly offset by other net income.
Q1 2024 included a fair value gain of £57 million on the stake in Haleon plc.
Q1 2025
£m AER CER
Operating profit Total 2,216 49% 50%
% of sales 29.5% 9.2% 9.0%
Core 2,533 4% 5%
% of sales 33.7% 0.5% 0.3%
Total operating profit margin was higher in the quarter mainly due to lower
CCL charges, partly offset by lower other net operating income.
Core operating profit growth in the quarter primarily reflected higher
turnover, favourable product mix and royalty income, partly offset by
increased investment in R&D, new asset launches and growth assets.
Growth was also offset by the Q1 2024 reversal of the legal provision related
to the Zejula royalty dispute, following a successful appeal.
Q1 2025
£m AER CER
Net finance expense Total 108 (19%) (20%)
Core 101 (23%) (24%)
The decrease in net finance costs in Q1 2025 was mainly driven by higher
income from net investment hedges, higher interest income on cash and lower
interest expense on tax.
Q1 2025
£m AER CER
Taxation Total 336 23% 24%
Tax rate % 15.9%
Core 434 7% 9%
Tax rate % 17.8%
The effective tax rate on Total results reflected the different tax effects of
the various Adjusting items included in Total results.
The effective tax rate on Core profits is broadly in line with expectations
for the year. Issues related to taxation are described in Note 14, 'Taxation'
in the Annual Report 2024. The Group continues to believe it has made adequate
provision for the liabilities likely to arise from periods that are open and
not yet agreed by relevant tax authorities. The ultimate liability for such
matters may vary from the amounts provided and is dependent upon the outcome
of agreements with relevant tax authorities.
Q1 2025
£m AER CER
Non-controlling Total 148 >100% >100%
interests ("NCIs")
Core 162 5% 6%
The increase in Total and Core NCIs in the quarter was primarily driven by
higher core profit allocations from ViiV Healthcare, and a lower remeasurement
loss on the CCL impacting Total NCIs.
Q1 2025
£p AER CER
Earnings per share Total 39.7p 55% 56%
Core 44.9p 4% 5%
The increase in the Q1 2025 Total EPS is driven by lower CCL movements.
The increase in the Core EPS in the quarter primarily reflected the growth in
Core operating profit as well as lower net finance costs, partly offset by a
higher effective taxation rate and higher non-controlling interests.
Currency impact on results
The results for Q1 2025 are based on average exchange rates, principally
$1.26/£1, €1.20/£1 and Yen193/£1. The period-end exchange rates were
$1.29/£1, €1.20/£1 and Yen193/£1. Comparative exchange rates are given on
page 32.
Q1 2025
£m/£p AER CER
Turnover 7,516 2% 4%
Earnings per share Total 39.7p 55% 56%
Core 44.9p 4% 5%
In Q1 2025, the adverse currency impact primarily reflected the strengthening
of Sterling against the Euro, Yen and emerging market currencies. Exchange
losses on the settlement of intercompany transactions in Q1 2024 resulted in a
favourable impact of three percentage points on Total EPS and two percentage
points on Core EPS growth at AER.
Cash generation
Cash flow
Q1 2025 Q1 2024
£m £m
Cash generated from operations (£m) 1,301 1,126
Total net cash inflow/(outflow) from operating activities (£m) 1,145 958
Free cash inflow/(outflow)* (£m) 697 289
Free cash flow growth (%) >100% >100%
Free cash flow conversion* (%) 43% 28%
Total net debt** (£m) 13,947 14,961
* Free cash flow and free cash flow conversion are defined on page 44. Free cash
flow is analysed on page 35.
** Net debt is analysed on pages 34 and 35.
Q1 2025
Cash generated from operations for the quarter was £1,301 million (Q1 2024:
£1,126 million). The increase primarily reflected higher operating profit
and a favourable timing impact from higher returns and rebates in comparison
to lower returns and rebates in Q1 2024 including the impact of the removal of
the AMP cap. This was partly offset by an adverse movement in receivables
driven by higher Arexvy and Shingrix collections in Q1 2024.
Total contingent consideration cash payments in the quarter were
£341 million (Q1 2024: £309 million). £338 million (Q1 2024:
£306 million) of these were recognised in cash flows from operating
activities, including cash payments made to Shionogi & Co. Ltd (Shionogi)
of £331 million (Q1 2024: £300 million).
Free cash inflow was £697 million for the quarter (Q1 2024: £289 million).
The increase was primarily driven by higher cash generated from operations,
lower capital expenditure on intangible assets and property, plant and
equipment, higher proceeds from the sale of intangible assets, and lower
dividends paid to non-controlling interests.
Total Net debt
At 31 March 2025, net debt was £13,947 million, compared with £13,095
million at 31 December 2024, comprising gross debt of £18,432 million and
cash and liquid investments of £4,485 million. See net debt information on
pages 34 and 35.
Net debt increased by £852 million primarily due to the net acquisition costs
of IDRx, Inc. (IDRx) and Cellphenomics GmbH totalling £800 million, dividends
paid to shareholders of £612 million, and shares purchased as part of the
2025 share buyback programme of £247 million. This was partly offset by free
cash inflow of £697 million and exchange gain on net debt of £187 million.
At 31 March 2025, GSK had short-term borrowings (including overdrafts and
lease liabilities) repayable within 12 months of £1,958 million and £2,192
million repayable in the subsequent year.
Contents
Page
Q1 2025 pipeline highlights 13
Responsible business 15
Total and Core results 17
Income statement 22
Statement of comprehensive income 23
Balance sheet 24
Statement of changes in equity 25
Cash flow statement 26
Sales tables 27
Segment information 29
Legal matters 30
Returns to shareholders 31
Additional information 32
R&D commentary 36
Reporting definitions 44
Guidance and outlooks, assumptions and cautionary statements 46
Independent Auditor's review report to GSK plc 48
Glossary 50
Contacts
GSK plc (LSE/NYSE:GSK) is a global biopharma company with a purpose to unite
science, technology, and talent to get ahead of disease together. Find out
more at www.gsk.com (http://www.gsk.com/) .
GSK enquiries:
Media Tim Foley +44 (0) 7780 494750 (London)
Kathleen Quinn +1 202 603 5003 (Washington)
Investor Relations Constantin Fest +44 (0) 7831 826525 (London)
James Dodwell +44 (0) 7881 269066 (London)
Mick Readey +44 (0) 7990 339653 (London)
Steph Mountifield +44 (0) 7796 707505 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 3126 (Philadelphia)
Registered in England & Wales:
No. 3888792
Registered Office:
79 New Oxford Street
London,
WC1A 1DG
Q1 2025 pipeline highlights (since 5 February 2025)
Medicine/vaccine Trial (indication, presentation) Event
Regulatory approvals or other regulatory actions Blenrep DREAMM-7/8 (2L+ multiple myeloma) Regulatory decision (UK)
Blujepa (gepotidacin) EAGLE-2/3 (uncomplicated urinary tract infection) Regulatory approval (US)
Arexvy RSV, adults aged 50-59 years at increased risk ACIP recommendation (US)
Penmenvy (MenABCWY (gen 1) vaccine) Meningococcal ABCWY Regulatory approval (US)
Penmenvy (MenABCWY (gen 1) vaccine) Meningococcal ABCWY ACIP recommendation (US)
Regulatory submissions or acceptances depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps Regulatory acceptance
(US)
depemokimab SWIFT-1/2 (severe asthma) Regulatory acceptance
(US)
Nucala MATINEE (chronic obstructive pulmonary disease) Regulatory acceptance (CN, EU)
Phase III data readouts or other significant events Zejula ZEAL-1L (1L maintenance non-small cell lung cancer) Phase III data readout
Anticipated pipeline milestones
Timing Medicine/vaccine Trial (indication, presentation) Event
H1 2025 depemokimab AGILE (severe asthma) Phase III data readout
linerixibat GLISTEN (cholestatic pruritus in primary biliary cholangitis) Regulatory submission
(US, EU)
Nucala MATINEE (chronic obstructive pulmonary disease) Regulatory decision (US)
Blenrep DREAMM-7/8 (2L+ multiple myeloma) Regulatory decision (JP)
cobolimab COSTAR (non-small cell lung cancer) Phase III data readout
Shingrix Shingles, adults aged 18+ years at increased risk Regulatory decision (CN)
Shingrix Shingles, liquid formulation Regulatory decision (US)
H2 2025 camlipixant CALM-1 (refractory chronic cough) Phase III data read out*
depemokimab SWIFT-1/2 (severe asthma) Regulatory decision (US)
depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps) Regulatory decision (US)
depemokimab NIMBLE (severe asthma) Phase III data readout
latozinemab INFRONT-3 (frontotemporal dementia) Phase III data read out
linerixibat GLISTEN (cholestatic pruritus in primary biliary cholangitis) Regulatory decision (US)
linerixibat GLISTEN (cholestatic pruritus in primary biliary cholangitis) Regulatory submission (CN, JP)
Ventolin Low carbon MDI (asthma) Phase III data readout
Ventolin Low carbon MDI (asthma) Regulatory submission (EU)
Blenrep DREAMM-7/8 (2L+ multiple myeloma) Regulatory decision (US, EU)
Blenrep DREAMM-8 (2L + multiple myeloma) Regulatory submission (CN)
cobolimab COSTAR, (2L non-small cell lung cancer) Regulatory submission
(US, EU)
*CALM-1 results will be disclosed together with CALM-2
Timing Medicine/vaccine Trial (indication, presentation) Event
H2 2025 Arexvy RSV, adults aged 60+ years Phase III read out (CN)
Arexvy RSV, adults aged 18-49 years at increased risk, 18+ immunocompromised Regulatory submission
(US, EU, JP)
Bexsero Meningococcal B (infants) Phase III data read out
gepotidacin EAGLE-1 (urogenital gonorrhoea) Regulatory submission (US)
gepotidacin EAGLE-1 (urogenital gonorrhoea) Regulatory decision (US)
tebipenem pivoxil PIVOT-PO (complicated urinary tract infection) Phase III data readout
tebipenem pivoxil PIVOT-PO (complicated urinary tract infection) Regulatory submission (US)
2026 camlipixant CALM-2 (refractory chronic cough) Phase III data read out
camlipixant CALM-1/2 (refractory chronic cough) Regulatory submission (US, EU, JP)
depemokimab OCEAN (Eosinophilic granulomatosis with polyangiitis) Phase III data read out
depemokimab OCEAN (Eosinophilic granulomatosis with polyangiitis) Regulatory submission
(US, EU, CN, JP)
depemokimab SWIFT-1/2 (severe asthma) Regulatory decision
(EU, CN, JP)
depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps) Regulatory decision
(EU, CN, JP)
latozinemab INFRONT-3 (frontotemporal dementia) Regulatory submission
(US, EU)
linerixibat GLISTEN (cholestatic pruritus in primary biliary cholangitis) Regulatory decision
(EU, CN, JP)
Nucala MATINEE (chronic obstructive pulmonary disease) Regulatory decision (EU, CN)
Ventolin Low carbon MDI (asthma) Regulatory decision (EU)
Blenrep DREAMM-7/8 (2L+ multiple myeloma) Regulatory decision (CN)
cobolimab COSTAR (2L non-small cell lung cancer) Regulatory decision (US, EU)
Jemperli AZUR-1 (rectal cancer) Phase II (pivotal) data read out
cabotegravir Q4M PrEP (HIV) Phase II (pivotal) data read out
cabotegravir Q4M PrEP (HIV) Regulatory submission (US)
cabotegravir Q4M PrEP (HIV) Regulatory decision (US)
Arexvy RSV, adults aged 60+ years Regulatory submission (CN)
Arexvy RSV, adults aged 18-49 years at increased risk and 18+ immunocompromised Regulatory decision
(US, EU, JP)
bepirovirsen B-WELL 1/2 (hepatitis B virus) Phase III data read out
bepirovirsen B-WELL 1/2 (hepatitis B virus) Regulatory submission
(US, EU, CN, JP)
bepirovirsen B-WELL 1/2 (hepatitis B virus) Regulatory decision (US, JP)
Bexsero Meningococcal B (infants) Regulatory submission (US)
Bexsero Meningococcal B (infants) Regulatory decision (US)
tebipenem pivoxil PIVOT-PO (complicated urinary tract infection) Regulatory decision (US)
Refer to pages 36 to 43 for further details on several key medicines and
vaccines in development by therapy area.
Trust: progress on our six priority areas for responsible business
Building Trust by operating responsibly is integral to GSK's strategy and
culture. This will support growth and returns to shareholders, reduce risk,
and help GSK's people thrive while delivering sustainable health impact at
scale. The Company has identified six Responsible Business focus areas that
address what is most material to GSK's business and the issues that matter the
most to its stakeholders. Highlights below include activity since Q4 2024
results. For more details on annual updates, please see GSK's Responsible
Business Performance Report 2024
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
(1).
Access
Commitment: to make GSK's vaccines and medicines available at value-based
prices that are sustainable for the business and implement access strategies
that increase the use of GSK's vaccines and medicines to treat and protect
underserved people.
Progress since Q4 2024:
• Burundi has become the tenth country to roll out RTS,S (Mosquirix), GSK's
world first malaria vaccine, as part of the routine immunisation schedule.
More information can be found here
(https://www.gavi.org/news/media-room/burundi-introduces-malaria-vaccine-routine-immunization)
(2).
• Performance metrics related to access are updated annually with related
details in GSK's Responsible Business Performance Report 2024
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
(1) on page 11.
Global health and health security
Commitment: develop novel products and technologies to treat and prevent
priority diseases, including pandemic threats.
Progress since Q4 2024:
• A phase II trial evaluating a pulmonary tuberculosis drug combination has
commenced with the first patient dosed as part of a partnership between GSK
and BioVersys which is aimed at researching and developing novel antibacterial
products for serious life-threatening infections caused by multidrug-resistant
bacteria. More information can be found here
(https://ir.bioversys.com/news/first-ever-patient-dosed-with-alpibectir-ethionamide-in-combination-with-first-line-tb-drugs-in-a-14-day/26cbb071-386b-400b-a07b-636e588777d2)
(3).
• GSK and Chugai Pharmaceutical have signed a collaboration agreement for the
development of an anti-dengue virus antibody, AID351. Under this agreement,
GSK will perform activities and evaluate potential funding for the initiation
of the related clinical studies. More information can be found here
(https://www.chugai-pharm.co.jp/english/news/detail/20250130170001_1126.html)
(4).
• Performance metrics related to global health and health security are updated
annually with related details in GSK's Responsible Business Performance Report
2024
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
(1) on page 16.
Environment
Commitment: committed to a net zero, nature-positive, healthier planet with
ambitious goals set for 2030 and 2045.
Progress since Q4 2024:
• GSK was featured in CDP's 'A List' for Climate Change and Water Security, and
scored a B for Forests in their most recent rankings.
• GSK and WWF announced a new 5-year partnership focused on building business
resilience and protecting and restoring freshwater ecosystems, both within
GSK's operations and in its supply chain in water-stressed basins in India and
Pakistan.
• GSK continued to make progress on transitioning to renewable energy,
co-leading a renewable power programme with suppliers in China through the
Sustainable Markets Initiative. Through this partnership, GSK and other
industry peers are expected to contribute an estimated 225 GWh of renewable
energy to the grid annually. GSK also signed a new deal as part of the
Energize programme which involved GSK, industry peers and suppliers across
Europe, and is set to contribute approximately 245 GWh of new renewable energy
annually to the grid.
• Performance metrics related to environment are updated annually with related
details in GSK's Responsible Business Performance Report 2024
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
(1) on page 19.
Inclusion
Commitment: meet patients' needs with research that includes those impacted by
the disease under study, attract and retain the best talent regardless of
background, and support all GSK people to thrive.
• Performance metrics related to inclusion are updated annually with related
details in GSK's Responsible Business Performance Report 2024
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
(1) on page 27.
Ethical standards
Commitment: promote ethical behaviour across GSK's business by supporting its
employees to do the right thing and working with suppliers that share GSK's
standards and operate responsibly.
• Performance metrics related to ethical standards are updated annually with
related details in GSK's Responsible Business Performance Report 2024
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
(1) on page 29.
Product governance
Commitment: maintain robust quality and safety processes and responsibly use
data and new technologies.
• Performance metrics related to product governance are updated annually with
related details in GSK's Responsible Business Performance Report 2024
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
((
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
)1) on page 34.
Responsible Business rating performance
Detailed below is how GSK performs in key Responsible Business ratings.
Current Previous
External benchmark score/ranking score/ranking Comments
S&P Global's Corporate Sustainability Assessment 78 80 Current score updated September 2024
Access to Medicines Index 3.72 4.06 Second in the Index, updated bi-annually, current results from November 2024
Antimicrobial resistance benchmark 84% 86% Led the benchmark since its inception in 2018; Current ranking updated
November 2021
CDP Climate Change A A- Updated annually, current scores updated February 2025 (for supplier
engagement, March 2023)
CDP Water Security A A-
CDP Forests (palm oil) B B
CDP Forests (timber) B B
CDP supplier engagement rating Leader Leader
Sustainalytics 15.0 15.4 1st percentile in pharma subindustry group; lower score represents lower risk.
Current score as at December 2024
MSCI AA AA Last rating action date: September 2023
Moody's ESG solutions 62 61 Current score updated August 2023
ISS Corporate Rating B+ B+ Current score updated October 2024
FTSE4Good Member Member Member since 2004, latest review in June 2024
ShareAction's Workforce Disclosure Initiative 79% 77% Current score updated January 2024
Footnotes:
(1) https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf
(https://www.gsk.com/media/11863/responsible-business-performance-report-2024.pdf)
(2) https://www.gavi.org/news/media-room/burundi-introduces-malaria-vaccine-routine-immunization
(https://www.gavi.org/news/media-room/burundi-introduces-malaria-vaccine-routine-immunization)
(3) https://ir.bioversys.com/news/first-ever-patient-dosed-with-alpibectir-ethionamide-in-combination-with-first-line-tb-drugs-in-a-14-day/26cbb071-386b-400b-a07b-636e588777d2
(https://ir.bioversys.com/news/first-ever-patient-dosed-with-alpibectir-ethionamide-in-combination-with-first-line-tb-drugs-in-a-14-day/26cbb071-386b-400b-a07b-636e588777d2)
(4) https://www.chugai-pharm.co.jp/english/news/detail/20250130170001_1126.html
(https://www.chugai-pharm.co.jp/english/news/detail/20250130170001_1126.html)
(5) https://www.savethechildren.net/ethiopia/news/innovations-breaking-barriers-childrens-immunisation-nigeria-and-ethiopia-win-major
(https://www.savethechildren.net/ethiopia/news/innovations-breaking-barriers-childrens-immunisation-nigeria-and-ethiopia-win-major)
Total and Core results
Total reported results represent the Group's overall performance.
GSK uses a number of non-IFRS measures to report the performance of its
business. Core results and other non-IFRS measures may be considered in
addition to, but not as a substitute for, or superior to, information
presented in accordance with IFRS. Core results are defined below and other
non-IFRS measures are defined on pages 44 and 45.
GSK believes that Core results, when considered together with Total results,
provide investors, analysts and other stakeholders with helpful complementary
information to understand better the financial performance and position of the
Group from period to period, and allow the Group's performance to be more
easily compared against the majority of its peer companies. These measures are
also used by management for planning and reporting purposes. They may not be
directly comparable with similarly described measures used by other companies.
GSK encourages investors and analysts not to rely on any single financial
measure but to review GSK's quarterly results announcements, including the
financial statements and notes, in their entirety.
GSK is committed to continuously improving its financial reporting, in line
with evolving regulatory requirements and best practice. In line with this
practice, GSK expects to continue to review and refine its reporting
framework.
Core results exclude the following items in relation to our operations from
Total results, together with the tax effects of all of these items:
• amortisation of intangible assets (excluding computer software and capitalised
development costs)
• impairment of intangible assets (excluding computer software) and goodwill
• major restructuring costs, which include impairments of tangible assets and
computer software, (under specific Board approved programmes that are
structural, of a significant scale and where the costs of individual or
related projects exceed £25 million), including integration costs following
material acquisitions
• transaction-related accounting or other adjustments related to significant
acquisitions
• proceeds and costs of disposal of associates, products and businesses;
significant settlement income; Significant legal charges (net of insurance
recoveries) and expenses on the settlement of litigation and government
investigations; other operating income other than royalty income, and other
items including amounts reclassified from the foreign currency translation
reserve to the income statement upon the liquidation of a subsidiary where the
amount exceeds £25 million
Costs for all other ordinary course smaller scale restructuring and legal
charges and expenses from operations are retained within both Total and Core
results.
As Core results include the benefits of Major restructuring programmes but
exclude significant costs (such as Significant legal, major restructuring and
transaction items) they should not be regarded as a complete picture of the
Group's financial performance, which is presented in Total results. The
exclusion of other Adjusting items may result in Core earnings being
materially higher or lower than Total earnings. In particular, when
significant impairments, restructuring charges and legal costs are excluded,
Core earnings will be higher than Total earnings.
GSK has undertaken a number of Major restructuring programmes in response to
significant changes in the Group's trading environment or overall strategy or
following material acquisitions. Within the Pharmaceuticals sector, the highly
regulated manufacturing operations and supply chains and long lifecycle of the
business mean that restructuring programmes, particularly those that involve
the rationalisation or closure of manufacturing or R&D sites are likely to
take several years to complete. Costs, both cash and non-cash, of these
programmes are provided for as individual elements are approved and meet the
accounting recognition criteria. As a result, charges may be incurred over a
number of years following the initiation of a Major restructuring programme.
Significant legal charges and expenses are those arising from the settlement
of litigation or government investigations that are not in the normal course
and materially larger than more regularly occurring individual matters. They
also include certain major legacy matters.
Reconciliations between Total and Core results, providing further information
on the key Adjusting items, are set out on pages 19 and 20.
GSK provides earnings guidance to the investor community on the basis of Core
results. This is in line with peer companies and expectations of the investor
community, supporting easier comparison of the Group's performance with its
peers. GSK is not able to give guidance for Total results as it cannot
reliably forecast certain material elements of the Total results, particularly
the future fair value movements on contingent consideration and put options
that can and have given rise to significant adjustments driven by external
factors such as currency and other movements in capital markets.
ViiV Healthcare
ViiV Healthcare is a subsidiary of the Group and 100% of its operating results
(turnover, operating profit, profit after tax) are included within the Group
income statement.
Earnings are allocated to the three shareholders of ViiV Healthcare on the
basis of their respective equity shareholdings (GSK 78.3%, Pfizer 11.7% and
Shionogi 10%) and their entitlement to preferential dividends, which are
determined by the performance of certain products that each shareholder
contributed. As the relative performance of these products changes over time,
the proportion of the overall earnings allocated to each shareholder also
changes. In particular, the increasing proportion of sales of dolutegravir and
cabotegravir-containing products has a favourable impact on the proportion of
the preferential dividends that is allocated to GSK. Adjusting items are
allocated to shareholders based on their equity interests. GSK was entitled to
approximately 85% of the Total earnings and 83% of the Core earnings of ViiV
Healthcare for 2024.
As consideration for the acquisition of Shionogi's interest in the former
Shionogi-ViiV Healthcare joint venture in 2012, Shionogi received the 10%
equity stake in ViiV Healthcare and ViiV Healthcare also agreed to pay
additional future cash consideration to Shionogi, contingent on the future
sales performance of the products being developed by that joint venture,
dolutegravir and cabotegravir. Under IFRS 3 'Business combinations', GSK was
required to provide for the estimated fair value of this contingent
consideration at the time of acquisition and is required to update the
liability to the latest estimate of fair value at each subsequent period end.
The liability for the contingent consideration recognised in the balance sheet
at the date of acquisition was £659 million. Subsequent remeasurements are
reflected within other operating income/(expense) and within Adjusting items
in the income statement in each period.
Cash payments to settle the contingent consideration are made to Shionogi by
ViiV Healthcare each quarter, based on the actual sales performance and other
income of the relevant products in the previous quarter. These payments reduce
the balance sheet liability and hence are not recorded in the income
statement. The cash payments made to Shionogi by ViiV Healthcare in the three
months ended 31 March 2025 were £331 million.
As the liability is required to be recorded at the fair value of estimated
future payments, there is a significant timing difference between the charges
that are recorded in the Total income statement to reflect movements in the
fair value of the liability and the actual cash payments made to settle the
liability.
Further explanation of the acquisition-related arrangements with ViiV
Healthcare are set out on pages 89 and 90 of the Annual Report 2024.
The reconciliations between Total results and Core results for Q1 2025 and Q1
2024 are set out below.
Three months ended 31 March 2025
Total Intangible Intangible Major Trans- Significant Core
results amort- impair- restruct- action- legal, Divest- results
£m isation ment uring related ments and £m
£m £m £m £m other
items
£m
Turnover 7,516 7,516
Cost of sales (1,937) 198 11 2 (1,726)
Gross profit 5,579 198 11 2 5,790
Selling, general and administration (2,070) 8 8 (6) (2,060)
Research and development (1,462) 21 64 1 (1) (1,377)
Royalty income 180 180
Other operating income/(expense) (11) 2 9 -
Operating profit 2,216 219 64 20 10 4 2,533
Net finance expense (108) 7 (101)
Profit before taxation 2,108 219 64 20 10 11 2,432
Taxation (336) (51) (16) (5) (30) 4 (434)
Tax rate % 15.9% 17.8%
Profit after taxation 1,772 168 48 15 (20) 15 1,998
Profit attributable to non-controlling interests 148 14 162
Profit/(loss) attributable to shareholders 1,624 168 48 15 (34) 15 1,836
1,772 168 48 15 (20) 15 1,998
Earnings per share 39.7p 4.1p 1.2p 0.4p (0.9p) 0.4p 44.9p
Weighted average number of shares (millions) 4,088 4,088
Three months ended 31 March 2024
Total Intangible Intangible Major Trans- Significant Core
results amort- impair- restruct- action- legal, Divest- results
£m isation ment uring related ments and £m
£m £m £m £m other
items
£m
Turnover 7,363 7,363
Cost of sales (1,970) 182 33 19 3 (1,733)
Gross profit 5,393 182 33 19 3 5,630
Selling, general and administration (2,087) 17 91 (1,979)
Research and development (1,434) 14 54 7 (1,359)
Royalty income 151 151
Other operating income/(expense) (533) 685 (152) -
Operating profit 1,490 196 54 57 704 (58) 2,443
Net finance expense (134) 2 (132)
Share of after tax profit/(loss) of associates and joint ventures (1) (1)
Profit before taxation 1,355 196 54 57 704 (56) 2,310
Taxation (274) (41) (14) (13) (76) 14 (404)
Tax rate % 20.2% 17.5%
Profit after taxation 1,081 155 40 44 628 (42) 1,906
Profit attributable to non-controlling interests 35 119 154
Profit attributable to shareholders 1,046 155 40 44 509 (42) 1,752
1,081 155 40 44 628 (42) 1,906
Earnings per share 25.7p 3.8p 1.0p 1.1p 12.5p (1.0p) 43.1p
Weighted average number of shares (millions) 4,069 4,069
Adjusting items Q1 2025
Major restructuring and integration
Total Major restructuring charges incurred in Q1 2025 were £20 million (Q1
2024: £57 million), analysed as follows:
Q1 2025 Q1 2024
Cash Non- Total Cash Non- Total
£m cash £m £m cash £m
£m £m
Separation restructuring programme 6 12 18 28 8 36
Significant acquisitions 1 - 1 19 - 19
Legacy programmes 1 - 1 2 - 2
8 12 20 49 8 57
The Separation restructuring programme incurred cash charges of £6 million
primarily from restructuring of some commercial and administrative functions
as well as Global Supply Chain. The non-cash charges of £12 million primarily
reflected the write down of assets in manufacturing locations.
Costs of significant acquisitions relate to integration costs of Affinivax
Inc. (Affinivax) which was acquired in Q3 2022, BELLUS Health Inc. acquired in
Q2 2023, Aiolos Bio, Inc. (Aiolos) acquired in Q1 2024 and IDRx acquired in Q1
2025.
Transaction-related adjustments
Transaction-related adjustments resulted in a net charge of £10 million (Q1
2024: £704 million), the majority of which related to charges/(credits) for
the remeasurement of contingent consideration liabilities, the liabilities for
the Pfizer put option, and Pfizer and Shionogi preferential dividends in ViiV
Healthcare.
Charge/(credit) Q1 2025 Q1 2024
£m £m
Contingent consideration on former Shionogi-ViiV Healthcare joint Venture 39 586
(including Shionogi preferential dividends)
ViiV Healthcare put options and Pfizer preferential dividends (60) 66
Contingent consideration on former Novartis Vaccines business 52 28
Contingent consideration on acquisition of Affinivax (33) 5
Other contingent consideration 4 -
Other adjustments 8 19
Total transaction-related charges 10 704
The £39 million charge relating to the contingent consideration for the
former Shionogi-ViiV Healthcare joint venture represented an increase in the
valuation of the contingent consideration due to Shionogi driven by the unwind
of the discount for £114 million partly offset by updated exchange rates and
net other remeasurements of £75 million. The £586 million charge in Q1 2024
primarily reflected updated sales forecasts due to improved longer term HIV
prospects, as well as exchange movements and the unwind of the discount. The
£60 million credit relating to the ViiV Healthcare put option and Pfizer
preferential dividends represented a decrease in the valuation of the put
option primarily as a result of updated exchange rates and lower cash
balances. An explanation of the accounting for the non-controlling interests
in ViiV Healthcare is set out on page 18.
There was a £52 million charge in the quarter relating to the contingent
consideration on the former Novartis Vaccines business primarily related to
changes to future sales forecasts and the unwind of the discount.
The £33 million credit relating to the contingent consideration on the
acquisition of Affinivax primarily related to updated milestone payment dates
partly offset by the unwind of the discount.
Significant legal charges, Divestments, and other items
Legal charges provide for all significant legal matters and are not broken out
separately by litigation or investigation.
Divestments and other items included other net income, including fair value
movements on equity investments and royalty income.
Financial information
Income statement
Q1 2025 Q1 2024
£m £m
TURNOVER 7,516 7,363
Cost of sales (1,937) (1,970)
Gross profit 5,579 5,393
Selling, general and administration (2,070) (2,087)
Research and development (1,462) (1,434)
Royalty income 180 151
Other operating income/(expense) (11) (533)
OPERATING PROFIT 2,216 1,490
Finance income 54 32
Finance expense (162) (166)
Share of after tax profit/(loss) of associates and joint ventures - (1)
PROFIT BEFORE TAXATION 2,108 1,355
Taxation (336) (274)
Tax rate % 15.9% 20.2%
PROFIT AFTER TAXATION 1,772 1,081
Profit attributable to non-controlling interests 148 35
Profit attributable to shareholders 1,624 1,046
1,772 1,081
EARNINGS PER SHARE 39.7p 25.7p
Diluted earnings per share 39.3p 25.4p
Statement of comprehensive income
Q1 2025 Q1 2024
£m £m
Total profit for the period 1,772 1,081
Items that may be reclassified subsequently to income statement:
Exchange movements on overseas net assets and net investment hedges 138 (190)
Reclassification of exchange movements on liquidation or disposal of overseas (1) -
subsidiaries and associates
Fair value movements on cash flow hedges (4) -
Cost of hedging 4 -
Reclassification of cash flow hedges to income statement (5) 2
132 (188)
Items that will not be reclassified to income statement:
Exchange movements on overseas net assets of non-controlling interests (8) 3
Fair value movements on equity investments (121) 78
Tax on fair value movements on equity investments 7 (15)
Fair value movements on cash flow hedges - 1
Remeasurement gains/(losses) on defined benefit plans 56 46
Tax on remeasurement losses/(gains) on defined benefit plans (14) (10)
(80) 103
Other comprehensive income/(expense) for the period 52 (85)
Total comprehensive income for the period 1,824 996
Total comprehensive income for the period attributable to:
Shareholders 1,684 958
Non-controlling interests 140 38
1,824 996
Balance sheet
31 March 2025 31 December 2024
£m £m
ASSETS
Non-current assets
Property, plant and equipment 9,154 9,227
Right of use assets 817 846
Goodwill 6,926 6,982
Other intangible assets 16,258 15,515
Investments in associates and joint ventures 99 96
Other investments 933 1,100
Deferred tax assets 6,410 6,757
Derivative instruments - 1
Other non-current assets 2,023 1,942
Total non-current assets 42,620 42,466
Current assets
Inventories 6,000 5,669
Current tax recoverable 442 489
Trade and other receivables 7,059 6,836
Derivative financial instruments 95 109
Liquid investments 21 21
Cash and cash equivalents 4,464 3,870
Assets held for sale 4 3
Total current assets 18,085 16,997
TOTAL ASSETS 60,705 59,463
LIABILITIES
Current liabilities
Short-term borrowings (1,958) (2,349)
Contingent consideration liabilities (1,175) (1,172)
Trade and other payables (15,149) (15,335)
Derivative financial instruments (81) (192)
Current tax payable (628) (703)
Short-term provisions (1,840) (1,946)
Total current liabilities (20,831) (21,697)
Non-current liabilities
Long-term borrowings (16,474) (14,637)
Corporation tax payable (31) -
Deferred tax liabilities (404) (382)
Pensions and other post-employment benefits (1,870) (1,864)
Derivative financial instruments (2) -
Other provisions (555) (589)
Contingent consideration liabilities (5,854) (6,108)
Other non-current liabilities (1,030) (1,100)
Total non-current liabilities (26,220) (24,680)
TOTAL LIABILITIES (47,051) (46,377)
NET ASSETS 13,654 13,086
EQUITY
Share capital 1,349 1,348
Share premium account 3,484 3,473
Retained earnings 8,307 7,796
Other reserves 1,017 1,054
Shareholders' equity 14,157 13,671
Non-controlling interests (503) (585)
TOTAL EQUITY 13,654 13,086
Statement of changes in equity
Share Share Retained Other Share- Non- Total
capital premium earnings reserves holder's controlling equity
£m £m £m £m equity interests £m
£m £m
At 1 January 2025 1,348 3,473 7,796 1,054 13,671 (585) 13,086
Profit for the period 1,624 1,624 148 1,772
Other comprehensive income /(expense) for the period 172 (112) 60 (8) 52
Total comprehensive income/(expense) for the period 1,796 (112) 1,684 140 1,824
Distributions to non-controlling interests (58) (58)
Dividends to shareholders (612) (612) (612)
Shares issued 1 11 12 12
Share buyback programme:
Purchase of treasury shares (1) - (701) (701) (701)
Write-down on shares held by ESOP Trusts (75) 75 -
Share-based incentive plans 103 103 103
At 31 March 2025 1,349 3,484 8,307 1,017 14,157 (503) 13,654
(1) Includes shares committed to repurchase under irrevocable contracts and
repurchases subject to settlement at the end of the period.
Share Share Retained Other Share- Non- Total
capital premium earnings reserves holder's controlling equity
£m £m £m £m equity interests £m
£m £m
At 1 January 2024 1,348 3,451 7,239 1,309 13,347 (552) 12,795
Profit for the period 1,046 - 1,046 35 1,081
Other comprehensive income/(expense) for the period (151) 63 (88) 3 (85)
Total comprehensive income/(expense) for the period 895 63 958 38 996
Distributions to non-controlling interests (97) (97)
Dividends to shareholders (568) (568) (568)
Realised after tax losses on disposal or liquidation of equity investments (47) 47 -
Share of associates and joint ventures realised profit/(loss) on disposal of 15 (15) -
equity investments
Shares issued 18 18 18
Write-down of shares held by ESOP Trusts (141) 141 -
Shares acquired by ESOP Trusts 2 457 (459) -
Share-based incentive plans 85 85 85
At 31 March 2024 1,348 3,471 7,935 1,086 13,840 (611) 13,229
Cash flow statement three months ended 31 March 2025
Q1 2025 Q1 2024
£m £m
Profit after tax 1,772 1,081
Tax on profits 336 274
Share of after tax loss/(profit) of associates and joint ventures - 1
Net finance expense 108 134
Depreciation, amortisation and other adjusting items 823 549
(Increase)/decrease in working capital (788) (311)
Contingent consideration paid (338) (306)
Increase/(decrease) in other net liabilities (excluding contingent (612) (296)
consideration paid)
Cash generated from operations 1,301 1,126
Taxation paid (156) (168)
Total net cash inflow/(outflow) from operating activities 1,145 958
Cash flow from investing activities
Purchase of property, plant and equipment (208) (248)
Proceeds from sale of property, plant and equipment 1 1
Purchase of intangible assets (240) (315)
Proceeds from sale of intangible assets 76 27
Purchase of equity investments (22) (18)
Proceeds from sale of equity investments - 1,055
Purchase of businesses, net of cash acquired (800) (719)
Contingent consideration paid (3) (3)
Disposal of businesses (1) (3)
Interest received 53 37
(Increase)/decrease in liquid investments - 22
Dividend and distributions from investments - 15
Total net cash inflow/(outflow) from investing activities (1,144) (149)
Cash flow from financing activities
Issue of share capital 12 18
Issue of long-term notes 2,018 -
Net increase/(decrease) in short-term loans - (323)
Increase in other short-term loans 59 -
Repayment of other short-term loans (159) -
Repayment of lease liabilities (57) (57)
Interest paid (69) (71)
Dividends paid to shareholders (612) (568)
Purchase of treasury shares (247) -
Distribution to non-controlling interests (58) (97)
Other financing items (29) 38
Total net cash inflow/(outflow) from financing activities 858 (1,060)
Increase/(decrease) in cash and bank overdrafts in the period 859 (251)
Cash and bank overdrafts at beginning of the period 3,403 2,858
Exchange adjustments (11) (19)
Increase/(decrease) in cash and bank overdrafts in the period 859 (251)
Cash and bank overdrafts at end of the period 4,251 2,588
Cash and bank overdrafts at end of period comprise:
Cash and cash equivalents 4,464 2,790
Overdrafts (213) (202)
4,251 2,588
Specialty Medicines turnover - three months ended 31 March 2025
Total US Europe International
Growth Growth Growth Growth
£m AER% CER% £m AER% CER% £m AER% CER% £m AER% CER%
HIV 1,714 6 7 1,133 10 9 373 2 5 208 (5) -
Dolutegravir products 1,288 (1) - 773 - - 323 - 2 192 (8) (4)
Tivicay 314 (11) (10) 174 (6) (6) 58 (9) (8) 82 (21) (18)
Triumeq 246 (21) (20) 168 (20) (21) 45 (24) (22) 33 (18) (10)
Juluca 158 1 1 124 2 1 31 (3) - 3 - -
Dovato 570 18 19 307 21 21 189 12 15 74 21 25
Cabenuva 294 38 38 240 40 40 46 31 37 8 14 14
Apretude 89 65 63 87 61 61 - - - 2 - -
Rukobia 38 15 15 32 3 3 3 50 - 3 >100 >100
Other 5 (44) (22) 1 (67) (100) 1 (67) - 3 - 33
Respiratory, Immunology and Inflammation 804 26 28 497 31 31 150 14 17 157 25 31
Nucala 444 19 21 213 18 18 125 15 18 106 25 32
Benlysta 359 38 39 284 43 43 31 15 19 44 26 31
Other 1 (51) (51) - - - (6) (50) (50) 7 17 17
Oncology 415 52 53 292 57 56 96 28 31 27 >100 >100
Jemperli 174 >100 >100 137 >100 >100 27 93 100 10 >100 >100
Zejula 131 (7) (5) 62 (14) (15) 56 (3) (2) 13 18 45
Blenrep - - - - - - - - - - - -
Ojjaara/Omjjara 112 >100 >100 94 88 86 14 >100 >100 4 >100 >100
Other (2) >(100) - (1) - - (1) - - - - -
Specialty Medicines 2,933 16 17 1,922 21 20 619 8 12 392 10 16
Vaccines turnover - three months ended 31 March 2025
Total US Europe International
Growth Growth Growth Growth
£m AER% CER% £m AER% CER% £m AER% CER% £m AER% CER%
Shingles 867 (8) (7) 372 (21) (21) 291 27 31 204 (17) (13)
Shingrix 867 (8) (7) 372 (21) (21) 291 27 31 204 (17) (13)
Meningitis 350 17 20 122 1 - 138 37 41 90 17 26
Bexsero 251 16 20 70 (3) (3) 135 38 42 46 (2) 9
Menveo 89 11 13 52 6 4 2 - - 35 21 28
Other 10 >100 >100 - - - 1 - - 9 >100 >100
RSV 78 (57) (57) 55 (64) (64) 19 >100 >100 4 (85) (85)
Arexvy 78 (57) (57) 55 (64) (64) 19 >100 >100 4 (85) (85)
Influenza 1 (92) (92) (4) >(100) >(100) - - - 5 (55) (55)
Fluarix, FluLaval 1 (92) (92) (4) >(100) >(100) - - - 5 (55) (55)
Established Vaccines 799 (5) (3) 343 4 3 167 (6) (3) 289 (12) (9)
Boostrix 151 9 11 88 4 4 35 6 9 28 40 45
Cervarix 11 (66) (62) - - - 2 (50) (50) 9 (68) (64)
Hepatitis 170 (3) (2) 92 1 1 46 (10) (6) 32 (3) (3)
Infanrix, Pediarix 145 - 1 82 (6) (6) 28 (10) (6) 35 30 33
Priorix, Priorix Tetra,Varilrix 96 23 26 23 >100 >100 29 - - 44 2 7
Rotarix 141 (8) (6) 54 (5) (5) 32 10 14 55 (19) (15)
Synflorix 51 13 18 - - - 1 (50) (50) 50 16 21
Other 34 (52) (52) 4 (20) (40) (6) >(100) >(100) 36 (46) (45)
Vaccines 2,095 (8) (6) 888 (18) (18) 615 21 24 592 (14) (10)
General Medicines turnover - three months ended 31 March 2025
Total US Europe International
Growth Growth Growth Growth
£m AER% CER% £m AER% CER% £m AER% CER% £m AER% CER%
Respiratory 1,710 (1) 1 887 3 2 357 (1) 1 466 (7) (2)
Anoro Ellipta 127 7 9 47 7 5 56 8 12 24 4 13
Flixotide/Flovent 99 (29) (27) 61 (36) (37) 18 - - 20 (23) (12)
Relvar/Breo Ellipta 265 (2) - 101 2 2 92 (6) (4) 72 (1) 4
Seretide/Advair 216 (23) (21) 56 (39) (40) 50 (18) (15) 110 (15) (11)
Trelegy Ellipta 675 14 15 479 13 12 83 11 13 113 24 30
Ventolin 185 10 12 108 26 26 30 20 24 47 (18) (14)
Other Respiratory 143 (8) (5) 35 59 59 28 (13) (12) 80 (22) (17)
Other General Medicines 778 (7) (3) 55 4 4 158 (12) (9) 565 (7) (2)
Augmentin 173 (7) (2) - - - 50 (7) (6) 123 (7) -
Lamictal 102 1 3 44 19 16 25 (11) (7) 33 (8) (3)
Other General Medicines 503 (9) (5) 11 (31) (25) 83 (15) (12) 409 (7) (2)
General Medicines 2,488 (3) - 942 3 2 515 (5) (2) 1,031 (7) (2)
Commercial Operations turnover
Total US Europe International
Growth Growth Growth Growth
£m AER% CER% £m AER% CER% £m AER% CER% £m AER% CER%
Three months ended 31 March 2025 7,516 2 4 3,752 5 4 1,749 8 11 2,015 (6) (2)
Segment information
Operating segments are reported based on the financial information provided to
the Chief Executive Officer and the responsibilities of the GSK Leadership
Team (GLT). GSK reports results under two segments: Commercial Operations and
Total R&D. Members of the GLT are responsible for each segment.
R&D investment is essential for the sustainability of the business.
However, for segment reporting the Commercial operating profits exclude
allocations of globally funded R&D.
The Total R&D segment is the responsibility of the Chief Scientific
Officer and is reported as a separate segment. The operating costs of this
segment includes R&D activities across Specialty Medicines, including HIV
and Vaccines. It includes R&D and some SG&A costs relating to
regulatory and other functions.
The Group's management reporting process allocates intra-Group profit on a
product sale to the market in which that sale is recorded, and the profit
analyses below have been presented on that basis.
Adjusting items reconciling segment profit and operating profit comprise items
not specifically allocated to segment profit. These include impairment and
amortisation of intangible assets, major restructuring costs, which include
impairments of tangible assets and computer software, transaction-related
adjustments related to significant acquisitions, proceeds and costs of
disposals of associates, products and businesses, Significant legal charges
and expenses on the settlement of litigation and government investigations,
other operating income other than royalty income, and other items including
amounts reclassified from the foreign currency translation reserve to the
income statement upon the liquidation of a subsidiary where the amount exceeds
£25 million.
Turnover by segment
Q1 2025 Q1 2024 Growth Growth
£m £m AER% CER%
Commercial Operations (total turnover) 7,516 7,363 2 4
Operating profit by segment
Q1 2025 Q1 2024 Growth Growth
£m £m AER% CER%
Commercial Operations 3,919 3,855 2 4
Research and Development (1,353) (1,308) 3 4
Segment profit 2,566 2,547 1 4
Corporate and other unallocated costs (33) (104)
Core operating profit 2,533 2,443 4 5
Adjusting items (317) (953)
Total operating profit 2,216 1,490 49 50
Finance income 54 32
Finance costs (162) (166)
Share of after tax profit/(loss) of associates and joint ventures - (1)
Profit before taxation 2,108 1,355 56 57
Commercial Operations Core operating profit of £3,919 million increased in
the quarter. Strong Specialty Medicines sales performance, favourable product
and regional mix, and higher royalty income were partly offset by investment
in new asset launches and growth assets.
The R&D segment operating expense of £1,353 million in the quarter
reflected continued spend across the portfolio, driven by Oncology investment
in ADCs with lower spend on Blenrep and Zejula as these studies progress to
completion. Investment in Specialty Medicines also increased driven by
camlipixant and the long acting TSLP asset.
Legal matters
The Group is involved in significant legal and administrative proceedings,
principally product liability, intellectual property, tax, anti-trust,
consumer fraud and governmental investigations, which are more fully described
in the 'Legal Proceedings' note in the Annual Report 2024. At 31 March 2025,
the Group's aggregate provision for legal and other disputes (not including
tax matters described on page 9) was £1,351 million (31 December 2024:
£1,446 million).
The Group may become involved in significant legal proceedings in respect of
which it is not possible to meaningfully assess whether the outcome will
result in a probable outflow, or to quantify or reliably estimate the
liability, if any, that could result from ultimate resolution of the
proceedings. In these cases, the Group would provide appropriate disclosures
about such cases, but no provision would be made.
The ultimate liability for legal claims may vary from the amounts provided and
is dependent upon the outcome of litigation proceedings, investigations and
possible settlement negotiations. The Group's position could change over time,
and, therefore, there can be no assurance that any losses that result from the
outcome of any legal proceedings will not exceed by a material amount the
amount of the provisions reported in the Group's financial accounts.
Significant legal developments since the date of the Annual Report 2024:
Product Liability
Zantac
As previously disclosed, the vast majority of the remaining cases have been
resolved or dismissed such that less than 1% of the state court cases remain.
GSK is in negotiations with plaintiffs' counsel on the remaining cases,
including two cases in Nevada state court with trials scheduled in 2026. The
trial in the Mayor & City of Baltimore action is scheduled to begin 28
September 2026.
The appeal of the Delaware Superior Court's decision allowing plaintiffs to
present expert evidence of general causation on all ten cancer types to a jury
remains pending. Oral argument was heard before the Delaware Supreme Court on
16 April 2025. A decision could be issued in Q2-Q3 2025.
As previously disclosed, approximately 14,000 product liability cases were
dismissed following the grant of defendants' Daubert motions in December 2022
in the Federal MDL proceeding. These are now on appeal by the plaintiffs to
the United States Court of Appeals for the Eleventh Circuit, along with
appeals in the medical monitoring and consumer class action cases. Oral
argument is tentatively scheduled for the week of 28 July 2025.
On 9 October 2024 GSK also reached an agreement to pay a total of $70 million
to resolve the Zantac qui tam complaint previously filed by Valisure. Both the
Department of Justice and the participating State Attorneys General approved
the agreement which was signed on 3 April 2025. The qui tam complaint will be
dismissed.
Intellectual Property
mRNA
GSK filed a patent infringement case against Pfizer/BioNTech in the United
States District Court for the District of Delaware alleging infringement of 8
US GSK patents by the COVID-19 vaccine, COMIRNATY®. Trial has been scheduled
for 7 June 2027.
GSK filed two separate patent infringement suits against Moderna, Inc. in the
United States District Court for the District of Delaware. The first suit
alleges infringement of 7 GSK patents by the COVID-19 vaccine, SPIKEVAX®.
Trial has been scheduled for 19 July 2027. The second suit alleges
infringement of 6 GSK patents by the RSV vaccine, mRESVIA®, and trial has
been scheduled for 23 August 2027.
On 2 January 2025, Acuitas Therapeutics Inc. filed a declaratory judgment
complaint against GSK, seeking judgment that COMIRNATY® does not infringe
five GSK patents. Acuitas also seeks a ruling that the patents are invalid.
GSK has moved to dismiss the complaint for lack of subject matter
jurisdiction.
RSV
On 1 April 2025, GSK and Pfizer Inc, reached a global settlement of all
litigation whereby Pfizer has been granted a worldwide license to certain
patents controlled by GSK relating to recombinant RSV prefusion F protein and
GSK will receive a royalty stream on sales of Abrysvo®. The pending
litigation in the United States District Court for the District of Delaware
was dismissed on 4 April 2025. Cases pending in other jurisdictions are also
in the process of being dismissed.
Returns to shareholders
Quarterly dividends
The Board has declared a first interim dividend for Q1 2025 of 16p per share
(Q1 2024: 15p per share).
Dividends remain an essential component of total shareholder return and GSK
recognises the importance of dividends to shareholders. On 23 June 2021, at
the GSK Investor Update, GSK set out that from 2022 a progressive dividend
policy will be implemented guided by a 40 to 60 per cent pay-out ratio through
the investment cycle. Consistent with this, GSK has declared a dividend of 16p
for Q1 2025. The expected dividend for 2025 is 64p per share. In setting its
dividend policy, GSK considers the capital allocation priorities of the Group
and its investment strategy for growth alongside the sustainability of the
dividend.
Payment of dividends
The equivalent interim dividend receivable by ADR holders will be calculated
based on the exchange rate on 8 July 2025. An annual fee of $0.03 per ADS (or
$0.0075 per ADS per quarter) is charged by the Depositary. The ex-dividend and
record dates will be 16 May 2025 with a payment date of 10 July 2025.
Paid/ Pence per £m
Payable share
2025
First interim 10 July 2025 16 654
2024
First interim 11 July 2024 15 612
Second interim 10 October 2024 15 612
Third interim 9 January 2025 15 612
Fourth interim 10 April 2025 16 656
61 2,492
Share capital in issue
At 31 March 2025, 4,085 million shares (Q1 2024: 4,078 million) were in free
issue (excluding Treasury shares and shares held by the ESOP Trusts). The
company issued 0.9 million shares in the quarter (Q1 2024: 1.9 million) under
employee share schemes for net proceeds of £12 million (Q1 2024: £18
million).
On 5th February 2025, GSK announced a £2 billion share buyback programme to
be completed over an 18 month period. As at 31 March 2025, 18 million shares
were repurchased and are being held as treasury shares, at a cost of £273
million, including transaction costs of £1 million.
Treasury shares for these purposes include shares purchased by GSK plc on 28
March 2025 and 31 March 2025. As announced via RNS, GSK purchased 834,200
ordinary shares on 28 March 2025 and 836,600 ordinary shares on 31 March 2025,
to be held as Treasury shares. Upon settlement of the relevant trades, the
shares purchased on those dates are held as Treasury shares, and are therefore
treated as Treasury shares for the purposes of the Q1 2025 reporting period
and this results announcement. The settlement cost of these shares was £25
million.
At 31 March 2025, the company held 187 million Treasury shares at a cost of
£3,230 million, of which 169 million shares of £2,957 million were
repurchased as part of previous share buyback programmes, which has been
deducted from retained earnings.
At 31 March 2025, the ESOP Trusts held 43.6 million shares of GSK shares, of
which 43 million were held for the future exercise of share options and share
awards and 0.6 million were held for the Executive Supplemental Savings plan.
The carrying value of £304 million has been deducted from other reserves.
The market value of these shares was £638 million.
Weighted average number of shares
The numbers of shares used in calculating basic and diluted earnings per share
are reconciled below:
Weighted average number of shares
Q1 2025 Q1 2024
millions millions
Weighted average number of shares - basic 4,088 4,069
Dilutive effect of share options and share awards 49 44
Weighted average number of shares - diluted 4,137 4,113
Additional information
Accounting policies and basis of preparation
This unaudited Results Announcement contains condensed financial information
for the three months ended 31 March 2025 and should be read in conjunction
with the Annual Report 2024, which was prepared in accordance with UK- adopted
international accounting standards in conformity with the requirements of the
Companies Act 2006 and the International Financial Reporting Standards (IFRS)
as issued by the International Accounting Standards Boards (IASB). This
Results Announcement has been prepared applying consistent accounting policies
to those applied by the Group in the Annual Report 2024.
The Group has not identified any changes to its key sources of accounting
judgements or estimations of uncertainty compared with those disclosed in the
Annual Report 2024.
This Results Announcement does not constitute statutory accounts of the Group
within the meaning of sections 434(3) and 435(3) of the Companies Act 2006.
The full Group accounts for 2024 were published in the Annual Report 2024,
which has been delivered to the Registrar of Companies and on which the report
of the independent auditor was unqualified and did not contain a statement
under section 498 of the Companies Act 2006.
Exchange rates
GSK operates in many countries and earns revenues and incurs costs in many
currencies. The results of the Group, as reported in Sterling, are affected by
movements in exchange rates between Sterling and other currencies. Average
exchange rates, as modified by specific transaction rates for large
transactions, prevailing during the period, are used to translate the results
and cash flows of overseas subsidiaries, associates and joint ventures into
Sterling. Period-end rates are used to translate the net assets of those
entities. The currencies which most influenced these translations and the
relevant exchange rates were:
Q1 2025 Q1 2024 2024
Average rates:
US$/£ 1.26 1.27 1.28
Euro/£ 1.20 1.16 1.18
Yen/£ 193 187 193
Period-end rates:
US$/£ 1.29 1.26 1.25
Euro/£ 1.20 1.17 1.20
Yen/£ 193 191 197
Contingent liabilities
There were contingent liabilities at 31 March 2025 in respect of arrangements
entered into as part of the ordinary course of the Group's business. No
material losses are expected to arise from such contingent liabilities.
Provision is made for the outcome of legal and tax disputes where it is both
probable that the Group will suffer an outflow of funds and it is possible to
make a reliable estimate of that outflow. Descriptions of the Significant
legal disputes to which the Group is a party are set out on page 30, and pages
287 to 290 of the 2024 Annual Report.
Net assets
The book value of net assets increased by £568 million from £13,086 million
at 31 December 2024 to £13,654 million at 31 March 2025. This primarily
reflected contribution from Total comprehensive income for the period partly
offset by dividends paid to shareholders and shares committed to be
repurchased under the first tranche of the 2025 share buyback programme and
associated transaction costs.
At 31 March 2025, the net deficit on the Group's pension plans decreased to
£18 million compared with £103 million at 31 December 2024. This decrease is
primarily due to an increase in the UK discount rate and a decrease in the UK
inflation rate, partly offset by a decrease in the US discount rate, and lower
UK and US asset values.
Other payables includes £428 million related to shares still to be purchased
as part of the first tranche of the 2025 share buyback programme, £25 million
for shares purchased but not settled at 31 March 2025, and £1 million of
transaction costs.
The estimated present value of the potential redemption amount of the Pfizer
put option related to ViiV Healthcare, recorded in Other payables in Current
liabilities, was £855 million (31 December 2024: £915 million).
Contingent consideration amounted to £7,029 million at 31 March 2025 (31
December 2024: £7,280 million) as follows:
Group Group
31 March 31 December 2024
2025 £m
£m
Contingent consideration estimated present value of amounts payable relating
to:
Former Shionogi-ViiV Healthcare joint venture 5,769 6,061
Former Novartis Vaccines business acquisition 605 575
Affinivax acquisition 454 502
Aiolos acquisition 129 130
Others 72 12
Contingent consideration liability at end of the period 7,029 7,280
Of the contingent consideration payable to Shionogi at 31 March 2025,
£1,120 million (31 December 2024: £1,127 million) is expected to be paid
within one year.
Movements in contingent consideration are as follows:
Q1 2025 ViiV Group
Healthcare £m
£m
Contingent consideration at beginning of the period 6,061 7,280
Additions - 61
Remeasurement through income statement and other movements 39 29
Cash payments: operating cash flows (331) (338)
Cash payments: investing activities - (3)
Contingent consideration at end of the period 5,769 7,029
Q1 2024 ViiV Group
Healthcare £m
£m
Contingent consideration at beginning of the period 5,718 6,662
Remeasurement through income statement and other movements 586 722
Cash payments: operating cash flows (300) (306)
Cash payments: investing activities - (3)
Contingent consideration at end of the period 6,004 7,075
Business acquisitions
On 13 January 2025, GSK announced it had entered into an agreement to acquire
100% of IDRx, Inc, a Boston based, clinical stage biopharmaceutical company
dedicated to developing precision therapies for the treatment of
gastrointestinal stromal tumours (GIST). The acquisition includes lead
molecule, IDRX-42, a highly selective investigational tyrosine kinase
inhibitor (TKI) that is designed to improve the outcomes for patients with
GIST. GSK acquired all of the outstanding equity interests in IDRx for a total
consideration of US$1.1 billion (£840 million) as adjusted for working
capital acquired paid upon closing and up to US$150 million (£119 million)
as an additional success-based regulatory milestone payment. The estimated
fair value of the contingent consideration payable was US$60 million (£48
million). In addition, GSK will also be responsible for success-based
milestone payments as well as tiered royalties for IDRX-42 owed to Merck KGaA,
Darmstadt, Germany. The transaction was subject to customary conditions,
including applicable regulatory agency clearances under the Hart Scott-Rodino
Act in the US, and subsequently closed on 21 February 2025.
The initial acquisition accounting was reflected in the first quarter of 2025
on a preliminary basis, the values below are provisional and subject to
change. The purchase price allocation is expected to be completed by the end
of Q4 2025.
Goodwill of £88 million has been recognised. The goodwill represents specific
synergies available to GSK from the business combination. The goodwill has
been allocated to the Group's R&D segment.
The provisional fair values of the net assets acquired, including goodwill,
are as follows:
£m
Net assets acquired:
Intangible assets 1,007
Cash and cash equivalents 48
Other net liabilities (52)
Deferred tax liabilities (203)
800
Goodwill 88
Total consideration 888
Of the £888 million consideration, £63 million was unpaid as at 31 March
2025.
On 15 January 2025, GSK acquired a Berlin based private company, Cellphenomics
GmbH, which has developed proprietary capabilities in developing durable
organoid models, for a total cash consideration of up to €44 million
(approximately £37 million) of which €15 million (£13 million) was unpaid
as at 31 March 2025. The acquisition is accounted for as a business
combination but is not considered a significant acquisition for the Group.
This agreement was not subject to closing conditions and the acquisition has
been completed.
Net debt information
Reconciliation of cash flow to movements in net debt
Q1 2025 Q1 2024
£m £m
Total Net debt at beginning of the period (13,095) (15,040)
Increase/(decrease) in cash and bank overdrafts 859 (251)
Increase/(decrease) in liquid investments - (22)
Issue of long-term notes (2,018) -
Net decrease/(increase) in short-term loans - 323
Increase in other short-term loans(1) (59) -
Repayment of other short-term loans(1) 159 -
Repayment of lease liabilities 57 57
Net debt of subsidiary undertakings acquired (1) -
Exchange adjustments 187 1
Other non-cash movements (36) (29)
Decrease/(increase) in net debt (852) 79
Total Net debt at end of the period (13,947) (14,961)
(1) Other short-term loans include bank loans presented within short-term
borrowings on the balance sheet, with an initial maturity of greater than
three months but less than twelve months.
Net debt analysis
31 March 2025 31 December 2024
£m £m
Liquid investments 21 21
Cash and cash equivalents 4,464 3,870
Short-term borrowings (1,958) (2,349)
Long-term borrowings (16,474) (14,637)
Total Net debt at the end of the period (13,947) (13,095)
Free cash flow reconciliation
Q1 2025 Q1 2024
£m £m
Net cash inflow/(outflow) from operating activities 1,145 958
Purchase of property, plant and equipment (208) (248)
Proceeds from sale of property, plant and equipment 1 1
Purchase of intangible assets (240) (315)
Proceeds from disposals of intangible assets 76 27
Net finance costs (16) (34)
Contingent consideration paid (reported in investing activities) (3) (3)
Distributions to non-controlling interests (58) (97)
Free cash inflow/(outflow) 697 289
Related party transactions
Details of GSK's related party transactions are disclosed on page 258 of the
2024 Annual Report.
R&D commentary
Pipeline overview
Medicines and vaccines in phase III development (including major lifecycle 18 Respiratory, Immunology and Inflammation (6)
innovation or under regulatory review)
• Nucala (anti-IL5 biologic) chronic obstructive pulmonary disease
• depemokimab (ultra long-acting anti-IL5 biologic) severe eosinophilic asthma,
eosinophilic granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis
with nasal polyps (CRSwNP), hyper-eosinophilic syndrome (HES)
• latozinemab (AL001, anti-sortilin) frontotemporal dementia
• camlipixant (P2X3 receptor antagonist) refractory chronic cough
• Ventolin (salbutamol, Beta 2 adrenergic receptor agonist) asthma
• linerixibat (IBATi) cholestatic pruritus in primary biliary cholangitis
Oncology (5)
• Blenrep (anti-BCMA ADC) multiple myeloma
• Jemperli (anti-PD-1) 1L endometrial cancer, colon cancer, rectal cancer, head
and neck cancer
• Zejula (PARP inhibitor) 1L ovarian and non-small cell lung cancer,
glioblastoma
• belrestotug (anti-TIGIT) 1L non-small cell lung cancer
• cobolimab (anti-TIM-3) 2L non-small cell lung cancer
Infectious Diseases (7)
• Arexvy (RSV vaccine) RSV adults (18-49 years of age at increased risk (AIR)
and 18+ immunocompromised)
• Blujepa (gepotidacin; bacterial topoisomerase inhibitor) uncomplicated urinary
tract infection and urogenital gonorrhoea
• bepirovirsen (HBV ASO) hepatitis B virus
• Bexsero (meningococcal B vaccine) infants (US)
• tebipenem pivoxil (antibacterial carbapenem) complicated urinary tract
infection
• ibrexafungerp (antifungal glucan synthase inhibitor) invasive candidiasis
• GSK4178116 (varicella vaccine) varicella new strain individuals 12 months of
age and older
Total medicines and vaccines in all phases of clinical development 70
Total projects in clinical development (inclusive of all phases and 91
indications)
Therapy area updates
The following provides updates on key medicines and vaccines by therapy area
that will help drive growth for GSK to meet its future outlooks.
Respiratory, Immunology and Inflammation
camlipixant (P2X3 receptor antagonist)
Camlipixant (BLU-5937) is an investigational, highly selective oral P2X3
antagonist currently in development for first-line treatment of adult patients
suffering from refractory chronic cough (RCC). The CALM phase III development
programme to evaluate the efficacy and safety of camlipixant for use in adults
with RCC is ongoing.
Trial name (population) Phase Design Timeline Status
CALM-1 (refractory chronic cough) III A 52-week, randomised, double-blind, placebo-controlled, parallel-arm efficacy Trial start: Recruiting
and safety trial with open-label extension of camlipixant in adult
participants with refractory chronic cough, including unexplained chronic Q4 2022
cough
NCT05599191
CALM-2 (refractory chronic cough) III A 24-week, randomised, double-blind, placebo-controlled, parallel-arm efficacy Trial start: Recruiting
and safety trial with open-label extension of camlipixant in adult
participants with refractory chronic cough, including unexplained chronic Q1 2023
cough
NCT05600777
depemokimab (long acting anti-IL5)
Depemokimab is in late-stage development in a range of IL-5 mediated
conditions including asthma with type 2 inflammation, chronic rhinosinusitis
with nasal polyps (CRSwNP), hypereosinophilic syndrome (HES) and eosinophilic
granulomatosis with polyangiitis (EGPA). It is the first ultra-long-acting
biologic engineered to have an extended half-life and high binding affinity
and potency for IL-5, enabling six-month dosing intervals in phase III
clinical trials.
Positive phase III data from the pivotal SWIFT-1 and SWIFT-2 trials in asthma
with type 2 inflammation and the ANCHOR-1 and ANCHOR-2 trials in patients with
CRSwNP have been published in The New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa2406673) and The Lancet
(https://urldefense.com/v3/__https:/www.thelancet.com/__;!!AoaiBx6H!xEbiVTNleywODU5RtCEXIYmHm_Yt1BlBPEeBJB-nP3PFJ-VuBGC5LRp8B82UXn0vJ0pcQtCBkNeo4vfBhZW9R0JysmlmCsU$)
respectively and are being used to support regulatory filings in major
markets.
Regulatory submissions seeking approval for the use of depemokimab in patients
with asthma with type 2 inflammation and in patients with CRSwNP, have been
accepted by the health authorities in four major markets; EU, China, Japan and
the US. Submissions in other markets are expected to progress through the
year.
Key phase III trials for depemokimab:
Trial name (population) Phase Design Timeline Status
SWIFT-1 (severe asthma) III A 52-week, randomised, double-blind, placebo-controlled, parallel-group, Trial start: Completed; primary endpoint met
multi-centre trial of the efficacy and safety of depemokimab adjunctive
therapy in adult and adolescent participants with severe uncontrolled asthma Q1 2021
with an eosinophilic phenotype
NCT04719832
Data reported:
Q2 2024
SWIFT-2 (severe asthma) III A 52-week, randomised, double-blind, placebo-controlled, parallel-group, Trial start: Completed; primary endpoint met
multi-centre trial of the efficacy and safety of depemokimab adjunctive
therapy in adult and adolescent participants with severe uncontrolled asthma Q1 2021
with an eosinophilic phenotype
NCT04718103
Data reported:
Q2 2024
AGILE (severe asthma) III A 52-week, open label extension phase of SWIFT-1 and SWIFT-2 to assess the Trial start: Active, not recruiting
long-term safety and efficacy of depemokimab adjunctive therapy in adult and
(exten adolescent participants with severe uncontrolled asthma with an eosinophilic Q1 2022
phenotype
NCT05243680 sion)
NIMBLE (severe asthma) III A 52-week, randomised, double-blind, double-dummy, parallel group, Trial start: Active, not recruiting
multi-centre, non-inferiority trial assessing exacerbation rate, additional
measures of asthma control and safety in adult and adolescent severe asthmatic Q1 2021
participants with an eosinophilic phenotype treated with depemokimab compared
NCT04718389 with mepolizumab or benralizumab
ANCHOR-1 (chronic rhinosinusitis with nasal polyps; CRSwNP) III Efficacy and safety of depemokimab in participants with CRSwNP Trial start: Complete; primary endpoint met
Q2 2022
NCT05274750
Data reported: Q3 2024
ANCHOR-2 (CRSwNP) III Efficacy and safety of depemokimab in participants with CRSwNP Trial start: Complete; primary endpoint met
Q2 2022
NCT05281523
Data reported:
Q3 2024
OCEAN (eosinophilic granulomatosis with polyangiitis; EGPA) III Efficacy and safety of depemokimab compared with mepolizumab in adults with Trial start: Recruiting
relapsing or refractory EGPA
Q3 2022
NCT05263934
DESTINY (hyper-eosinophilic syndrome; HES) III A 52-week, randomised, placebo-controlled, double-blind, parallel group, Trial start: Recruiting
multicentre trial of depemokimab in adults with uncontrolled HES receiving
standard of care (SoC) therapy Q3 2022
NCT05334368
Nucala (mepolizumab)
Nucala is a first in class anti-IL-5 biologic and the only treatment approved
for use in the US and Europe across four IL-5 medicated conditions: severe
asthma with an eosinophilic phenotype, EGPA, HES and CRSwNP.
In September 2024, positive results from MATINEE, a phase III trial
investigating mepolizumab in patients with chronic obstructive pulmonary
disease (COPD) were announced. MATINEE met its primary endpoint with the
addition of mepolizumab to inhaled maintenance therapy showing a statistically
significant and clinically meaningful reduction in the annualised rate of
moderate/severe exacerbations versus placebo, with patients treated for up to
104 weeks. Publication of the full results of MATINEE is expected in Q2 2025.
In Q1 2025, regulators in the EU and China accepted the MATINEE data for
review as part of the regulatory process to seek an indication for the use of
mepolizumab in patients with COPD. Regulatory review in the US is ongoing with
a decision expected in May 2025.
Key trials for Nucala:
Trial name (population) Phase Design Timeline Status
MATINEE (chronic obstructive pulmonary disease; COPD) III A multicentre randomised, double-blind, parallel-group, placebo-controlled Trial start: Complete; primary endpoint met
trial of mepolizumab 100 mg subcutaneously as add-on treatment in participants
with COPD experiencing frequent exacerbations and characterised by eosinophil Q4 2019
levels
NCT04133909
Data reported:
Q3 2024
Oncology
Blenrep (belantamab mafodotin)
Based on positive results from the phase III head-to-head DREAMM-7 and
DREAMM-8 trials, GSK is pursuing regulatory approvals worldwide for Blenrep
combinations for the treatment of relapsed or refractory multiple myeloma. In
April 2025, the UK's Medicines and Healthcare products Regulatory Agency
(MHRA) approved Blenrep in second line and later multiple myeloma, its first
regulatory approval in this treatment setting anywhere in the world.
Additional submissions are under review in 14 markets, with key approvals
expected in major markets in 2025, including the US with a Prescription Drug
User Fee Act (PDUFA) date of 23 July.
GSK continues to explore the potential for belantamab mafodotin to help
address unmet need for patients with multiple myeloma, in early treatment
lines and in combination with novel therapies and standard of care treatments
through the DREAMM clinical trial programme. The programme includes DREAMM-10,
a phase III trial evaluating belantamab mafodotin plus lenalidomide and
dexamethasone (BRd) versus daratumumab plus lenalidomide and dexamethasone
(DRd) in patients with newly diagnosed transplant ineligible multiple myeloma.
Key phase III trials for Blenrep:
Trial name (population) Phase Design Timeline Status
DREAMM-7 (2L+ multiple myeloma; MM) III A multi-centre, open-label, randomised trial to evaluate the efficacy and Trial start: Active, not recruiting; primary endpoint met
safety of the combination of belantamab mafodotin, bortezomib, and
dexamethasone (B-Vd) compared with the combination of daratumumab, bortezomib Q2 2020
and dexamethasone (D-Vd) in participants with relapsed/refractory multiple
NCT04246047 myeloma
Primary data reported:
Q4 2023
DREAMM-8 (2L+ MM) III A multi-centre, open-label, randomised trial to evaluate the efficacy and Trial start: Active, not recruiting, primary endpoint met
safety of belantamab mafodotin in combination with pomalidomide and
dexamethasone (B-Pd) versus pomalidomide plus bortezomib and dexamethasone Q4 2020
(P-Vd) in participants with relapsed/refractory multiple myeloma
NCT04484623
Primary data reported:
Q1 2024
DREAMM-10 (1L MM) III A multi-centre, open-label, randomised trial to evaluate the efficacy and Trial start: Recruiting
safety of belantamab mafodotin, lenalidomide and dexamethasone (B-Rd) versus
NCT06679101 daratumumab, lenalidomide, and dexamethasone (D-Rd) in participants with newly Q4 2024
diagnosed multiple myeloma who are ineligible for autologous stem cell
transplantation
Jemperli (dostarlimab)
Jemperli (dostarlimab) is the foundation of GSK's immuno-oncology-based
research and development programme. It is the only approved
immuno-oncology-based treatment regimen to demonstrate a statistically
significant and clinically meaningful overall survival benefit for the
first-line treatment of adult patients with primary advanced or recurrent
endometrial cancer irrespective of biomarker status. The ongoing development
programme includes our AZUR trials in dMMR/MSI-H locally advanced rectal
cancer and resectable dMMR/MSI-H colon cancer; our JADE phase III trial in
locally advanced unresected head and neck cancer; our COSTAR Lung phase III
trial in combination with anti-TIM-3 compound cobolimab and chemotherapy in
second-line non-small cell lung cancer (NSCLC); and the GALAXIES-Lung-301
phase III trial in combination with anti-TIGIT compound belrestotug in
firstline locally advanced or metastatic PD-1-selected NSCLC.
Key trials for Jemperli:
Trial name (population) Phase Design Timeline Status
RUBY (1L stage III or IV endometrial cancer) III A randomised, double-blind, multi-centre trial of dostarlimab plus Trial start: Active, not recruiting; primary endpoints met
carboplatin-paclitaxel with and without niraparib maintenance versus placebo
plus carboplatin-paclitaxel in patients with recurrent or primary advanced Q3 2019
endometrial cancer
NCT03981796
Part 1 data reported:
Q4 2022
Part 2 data reported:
Q4 2023
PERLA (1L metastatic non-small cell lung cancer) II A randomised, double-blind trial to evaluate the efficacy of dostarlimab plus Trial start: Complete; primary endpoint met
chemotherapy versus pembrolizumab plus chemotherapy in metastatic non-squamous
non-small cell lung cancer Q4 2020
NCT04581824
Primary data reported:
Q4 2022
GARNET (advanced solid tumours) I/II A multi-centre, open-label, first-in-human trial evaluating dostarlimab in Trial start: Recruiting
participants with advanced solid tumours who have limited available treatment
options Q1 2016
NCT02715284
Primary data reported:
Q1 2019
AZUR-1 (locally advanced rectal cancer) II A single-arm, open-label trial with dostarlimab monotherapy in participants Trial start: Active, not recruiting
with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Q1 2023
NCT05723562
AZUR-2 (untreated perioperative T4N0 or stage III colon cancer) III An open-label, randomised trial of perioperative dostarlimab monotherapy Trial start: Recruiting
versus standard of care in participants with untreated T4N0 or stage III
NCT05855200 dMMR/MSI-H resectable colon cancer Q3 2023
JADE (locally advanced unresected head and neck cancer) III A randomised, double-blind, study to evaluate dostarlimab versus placebo as Trial start: Recruiting
sequential therapy after chemoradiation in participants with locally advanced
NCT06256588 unresected head and neck squamous cell carcinoma Q1 2024
COSTAR Lung (advanced non-small cell lung cancer that has progressed on prior II/III A multi-centre, randomised, parallel group treatment, open label trial Trial start: Active, not recruiting
PD-(L)1 therapy and chemotherapy) comparing cobolimab + dostarlimab + docetaxel to dostarlimab + docetaxel to
docetaxel alone in participants with advanced non-small cell lung cancer who Q4 2020
NCT04655976 have progressed on prior anti-PD-(L)1 therapy and chemotherapy
GALAXIES-Lung 301 (untreated, unresectable, locally advanced or metastatic III A randomized, multicenter, double-blind, trial investigating belrestotug in Trial start: Recruiting
PD-L1 high non-small cell lung cancer) combination with dostarlimab compared with placebo in combination with
pembrolizumab in participants with previously untreated, unresectable, locally Q2 2024
NCT06472076 advanced or metastatic PD-L1 selected non-small cell lung cancer
Zejula (niraparib)
GSK continues to assess the potential of niraparib monotherapy and in
combination with other agents across multiple tumour types. Niraparib
monotherapy is being evaluated in patients with newly diagnosed, MGMT
unmethylated glioblastoma in the phase III GLIOFOCUS trial (NCT06388733)
sponsored by the Ivy Brain Tumor Center and supported by GSK. In addition, the
ongoing development programme includes several phase III combination studies
including the RUBY Part 2 trial of niraparib and dostarlimab in recurrent or
primary advanced endometrial cancer; the FIRST trial of niraparib and
dostarlimab in stage III or IV nonmucinous epithelial ovarian cancer; and the
ZEAL-1L trial of niraparib plus pembrolizumab in advanced/metastatic non-small
cell lung cancer.
In April 2025, results showed that the phase III ZEAL-1L trial did not meet
its primary endpoint of progression-free survival. There were no new safety
findings; safety results were generally consistent with the known safety
profile of each individual agent. GSK is planning to present the results at an
upcoming scientific meeting. Results will be shared with global health
authorities as appropriate.
Key ongoing phase III trials for Zejula (see also RUBY Part 2 in Jemperli
section):
Trial name (population) Phase Design Timeline Status
ZEAL-1L (1L advanced non-small cell lung cancer maintenance) III A randomised, double-blind, placebo-controlled, multi-centre trial comparing Trial start: Active not recruiting, has results
niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance
therapy in participants whose disease has remained stable or responded to Q4 2020
first-line platinum-based chemotherapy with pembrolizumab for Stage IIIB/IIIC
NCT04475939 or IV non-small cell lung cancer
Data reported: Q1 2025
FIRST (1L ovarian cancer maintenance) III A randomised, double-blind, comparison of platinum-based therapy with Trial start: Complete: primary endpoint met
dostarlimab (TSR-042) and niraparib versus standard of care platinum-based
therapy as first-line treatment of stage III or IV non-mucinous epithelial Q4 2018
ovarian cancer
NCT03602859
Data reported:
Q4 2024
HIV
As pioneers in long-acting injectables, GSK is focused on the next-generation
of HIV innovation with integrase inhibitors (INSTIs) - the gold standard for
HIV treatment and prevention - at the core. We remain confident that our
pipeline - including three new INSTIs in development and five planned
launches, will continue to drive performance over the coming decade.
In March 2025, ViiV Healthcare, majority owned by GSK, shared 81 abstracts at
CROI (Conference on Retroviruses and Opportunistic Infections), the premier
scientific HIV conference. Data spanned our innovative HIV treatment and
prevention portfolio, and pipeline, reinforcing our position as leaders in HIV
innovation with a focus on long-acting injectables.
Key data included real-world and implementation data highlighting the
effectiveness Cabenuva (cabotegravir + rilpivirine LA) and Apretude
(cabotegravir LA (CAB LA) for PrEP) - the only approved long-acting injectable
therapies for HIV treatment and prevention dosed every two-months - among a
broad range of populations. These data reinforce confidence in the competitive
profile, efficacy, safety and tolerability of our long-acting medicines
delivering on the needs of patients today.
Data were also shared highlighting the progress of three high potential assets
in our treatment pipeline:
•VH184 (third generation INSTI): phase IIa results demonstrated rapid and
high potency, positive safety results and no drug resistance mutations. These
promising early data support further development of VH184 as the backbone of
the next generation of HIV treatment regimens.
•N6LS (bNAb): phase IIb data showed high efficacy and tolerability. These
results combined with pharmacokinetic (PK) data support progressing this asset
to explore six-monthly dosing.
•VH499 (investigational capsid inhibitor): phase IIa data showed potent
antiviral activity and favourable safety, supporting further development of
this asset.
The assets that will deliver six-monthly dosing for treatment are expected to
be confirmed in 2026, with a Q6M registrational study start planned in 2027.
We expect our Q6M regimen to contain a combination of one of three long-acting
INSTIs (CAB ULA, VH184 or VH310) with either our bNAB N6LS or VH499, our
capsid inhibitor.
Trial name (population) Phase Design Timeline Status
EXTEND 4M (HIV) II Phase IIb open label, single arm, repeat dose study to investigate the safety, Trial start: Active, not recruiting
tolerability and pharmacokinetics (PK) of CAB ULA administered intramuscularly
NCT06741397 every four months in participants at risk of acquiring HIV-1. Q4 2024
EMBRACE (HIV) IIb The study aims at evaluating the efficacy of VH3810109, dosed in accordance Q3 2023 Active, not recruiting
with the dosing schedule as either intravenous (IV) infusion or subcutaneous
NCT05996471 (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with
cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing
schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced
adult participants living with HIV.
Infectious Diseases
Arexvy (respiratory syncytial virus vaccine, adjuvanted)
GSK continues to generate data strengthening the body of evidence supporting
the robust profile of its RSV vaccine for adults, Arexvy. In March 2025, 17
abstracts were presented at the International RSV Symposium in Brazil to
further evaluate the unmet medical need associated with RSV and disclose new
data on the immunogenicity and safety of Arexvy. Positive data on the
co-administration of Arexvy with the standard of care for adult pneumococcal
vaccination (PCV20) were disclosed at the congress of the European Society of
Clinical Microbiology and Infectious Diseases (ESCMID) in April.
In April 2025, the Advisory Committee on Immunization Practices (ACIP) voted
in favour of recommending the use of RSV vaccines including Arexvy in adults
aged 50-59 who are at increased risk for severe RSV disease. This represents
over 13 million people, including those with conditions like COPD, asthma,
diabetes, heart disease and those in residential care. This expands on ACIP's
previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who
are at increased risk and all adults aged 75 and older. The vaccine has now
been approved for use in 66 markets worldwide.
Key phase III trials for Arexvy:
Trial name (population) Phase Design Timeline Status
RSV OA=ADJ-004 III A randomised, open-label, multi-country trial to evaluate the immunogenicity, Trial start: Active, not recruiting; primary endpoint met
safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA
(Adults ≥ 60 years old) investigational vaccine and different revaccination schedules in adults aged Q1 2021
60 years and above
NCT04732871 Primary data reported:
Q2 2022
RSV OA=ADJ-006 III A randomised, placebo-controlled, observer-blind, multi-country trial to Trial start: Complete; primary endpoint met
demonstrate the efficacy of a single dose of GSK's RSVPreF3 OA investigational
(ARESVI-006; Adults ≥ 60 years old) vaccine in adults aged 60 years and above Q2 2021
NCT04886596 Primary data reported:
Q2 2022;
two season data reported:
Q2 2023;
three season data reported: Q3 2024
RSV OA=ADJ-012 IIIb An Extension and Crossover Vaccination Study on the Immune Response and Safety Trial start: Recruiting
of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of
(Adults aged 60 years and above) Age and Above Who Participated in RSV OA=ADJ-006 Study Q3 2024
NCT06534892
RSV OA=ADJ-007 III An open-label, randomised, controlled, multi-country trial to evaluate the Trial start: Complete; primary endpoint met
immune response, safety and reactogenicity of RSVPreF3 OA investigational
(Adults ≥ 60 years old) vaccine when co-administered with FLU-QIV vaccine in adults aged 60 years and Q2 2021
above
NCT04841577 Primary data reported:
Q4 2022
RSV OA=ADJ-008 III A phase III, open-label, randomised, controlled, multi country trial to Trial start: Complete; primary endpoint met
evaluate the immune response, safety and reactogenicity of RSVPreF3 OA
investigational vaccine when co-administered with FLU HD vaccine in adults Q4 2022
aged 65 years and above
(Adults ≥ 65 years old)
Primary data reported:
NCT05559476 Q2 2023
RSV OA=ADJ-009 III A randomised, double-blind, multi-country trial to evaluate consistency, Trial start: Complete; primary endpoint met
safety, and reactogenicity of 3 lots of RSVPreF3 OA investigational vaccine
(Adults ≥ 60 years old) administrated as a single dose in adults aged 60 years and above Q4 2021
NCT05059301 Trial end:
Q2 2022
RSV OA=ADJ-017 III A phase III, open-label, randomised, controlled, multi-country trial to Trial start: Complete; data analysis ongoing
evaluate the immune response, safety and reactogenicity of an RSVPreF3 OA
(Adults ≥ 65 years old) investigational vaccine when co-administered with FLU aQIV (inactivated Q4 2022
influenza vaccine - adjuvanted) in adults aged 65 years and above
NCT05568797 Primary data reported:
Q2 2023
RSV OA=ADJ-018 III A phase III, observer-blind, randomised, placebo-controlled trial to evaluate Trial start: Complete; primary endpoint met
the non-inferiority of the immune response and safety of the RSVPreF3 OA
(Adults 50-59 years) investigational vaccine in adults 50-59 years of age, including adults at Q4 2022
increased risk of respiratory syncytial virus lower respiratory tract disease,
NCT05590403 compared to older adults ≥60 years of age Primary data reported:
Q4 2023
Key phase III trials for Arexvy (continued):
RSV OA=ADJ-019 III An open-label, randomised, controlled, multi-country trial to evaluate the Trial start: Complete; primary endpoint met
immune response, safety and reactogenicity of RSVPreF3 OA investigational
(Adults ≥ 60 years old) vaccine when co-administered with PCV20 in adults aged 60 years and older Q2 2023
NCT05879107 Primary data reported: Q1 2025
RSV OA=ADJ-023 IIb A randomised, controlled, open-label trial to evaluate the immune response and Trial start: Active, not recruiting; primary endpoint met
safety of the RSVPreF3 OA investigational vaccine in adults (≥50 years of
(Immunocompromised Adults 50-59 years) age) when administered to lung and renal transplant recipients comparing one Q3 2023
versus two doses and compared to healthy controls (≥50 years of age)
receiving one dose Primary data reported:
NCT05921903 Q4 2024
RSV-OA=ADJ-020 III A study on the safety and immune response of investigational RSV OA vaccine in Trial start: Complete; primary endpoint met
combination with herpes zoster vaccine in healthy adults
(Adults aged >=50 years of age) Q3 2023
NCT05966090 Primary data reported:
Q3 2024
RSV-OA=ADJ-013 III An open-label, randomized, controlled study to evaluate the immune response, Trial start: Active, not recruiting
safety and reactogenicity of RSVPreF3 OA investigational vaccine when
(Adults aged 50 years and above) co-administered with a COVID-19 mRNA vaccine Q2 2024
NCT06374394
RSV OA=ADJ-025 IIIb An open-label study to evaluate the non-inferiority of the immune response and Trial start: Complete; primary endpoint met
to evaluate the safety of the RSVPreF3 OA investigational vaccine in adults
(Adults, 18-49 years of age, at increased risk for RSV disease and older adult 18-49 years of age at increased risk for Respiratory Syncytial Virus disease, Q2 2024
participants, >=60 YOA) compared to older adults >=60 years of age
Primary data reported:
NCT06389487
Q3 2024
RSV OA=ADJ-021 III A study on the immune response, safety and the occurrence of Respiratory Trial start: Recruiting
Syncytial Virus (RSV)-associated respiratory tract illness after
(Adults aged 60 years and above) administration of RSV OA vaccine in adults 60 years and older in China and Q3 2024
other countries
NCT06551181
bepirovirsen (HBV ASO)
Bepirovirsen, a triple-action antisense oligonucleotide, is a potential new
treatment option for people with chronic hepatitis B (CHB) that has been
granted Fast Track designation by the US FDA and SENKU designation by the
Japanese Ministry of Health, Labour and Welfare in Japan for the treatment of
CHB. To further expand development in novel sequential regimens, GSK has
entered an agreement for an exclusive worldwide license to develop and
commercialise daplusiran/tomligisiran (GSK5637608, formerly JNJ-3989), an
investigational hepatitis B virus-targeted small interfering ribonucleic acid
(siRNA) therapeutic. This agreement provides an opportunity to investigate a
novel sequential regimen to pursue functional cure in an even broader patient
population with bepirovirsen. Phase IIb trials started in Q4 2024.
Key trials for bepirovirsen:
Trial name (population) Phase Design Timeline Status
B-Well 1 bepirovirsen in nucleos(t)ide treated patients (chronic hepatitis B) III A multi-centre, randomised, double-blind, placebo-controlled trial to confirm Trial Start: Active, not recruiting
the efficacy and safety of treatment with bepirovirsen in participants with
NCT05630807 chronic hepatitis B virus Q1 2023
B-Well 2 bepirovirsen in nucleos(t)ide treated patients (chronic hepatitis B) III A multi-centre, randomised, double-blind, placebo-controlled trial to confirm Trial Start: Active, not recruiting
the efficacy and safety of treatment with bepirovirsen in participants with
chronic hepatitis B virus Q1 2023
NCT05630820
B-United bepirovirsen sequential therapy with daplusiran/tomligisiran in IIb A multi-centre, randomized, partially placebo-controlled, double-blind study Trial start: Recruiting
nucleos(t)ide treated patients (chronic hepatitis B) to investigate the safety and efficacy of sequential therapy with
daplusiran/tomligisiran followed by bepirovirsen in participants with chronic Q4 2024
NCT06537414 hepatitis B virus on background nucleos(t)ide analogue therapy
Blujepa (gepotidacin; bacterial topoisomerase inhibitor)
In March 2025, the US FDA approved Blujepa (gepotidacin) for the treatment of
female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with
uncomplicated urinary tract infections (uUTIs) caused by the following
susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae,
Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus
faecalis. This is the first in a new class of oral antibiotics for uUTIs in
nearly 30 years.
Blujepa is a first-in-class oral antibiotic with a novel mechanism of action
that is part of GSK's infectious diseases portfolio. It is also being
investigated for the treatment of urogenital gonorrhoea. Positive data from
three pivotal trials demonstrate its potential to provide a new oral treatment
option for patients, including those with drug resistant infections. Filings
for gonorrhoea are expected to follow later in 2025.
Key phase III trials for gepotidacin:
Trial name (population) Phase Design Timeline Status
EAGLE-1 (uncomplicated urogenital gonorrhoea) III A randomised, multi-centre, open-label trial in adolescent and adult Trial start: Complete;
participants comparing the efficacy and safety of gepotidacin to ceftriaxone
plus azithromycin in the treatment of uncomplicated urogenital gonorrhoea Q4 2019 primary endpoint met
caused by Neisseria gonorrhoeae
NCT04010539
Data reported:
Q1 2024
EAGLE-2 (females with uUTI / acute cystitis) III A randomised, multi-centre, parallel-group, double-blind, double-dummy trial Trial start: Complete; primary endpoint met
in adolescent and adult female participants comparing the efficacy and safety
of gepotidacin to nitrofurantoin in the treatment of uncomplicated urinary Q4 2019
tract infection (acute cystitis)
NCT04020341
Data reported:
Q2 2023
EAGLE-3 (females with uUTI / acute cystitis) III A randomised, multi-centre, parallel-group, double-blind, double-dummy trial Trial start: Complete; primary endpoint met
in adolescent and adult female participants comparing the efficacy and safety
of gepotidacin to nitrofurantoin in the treatment of uncomplicated urinary Q2 2020
tract infection (acute cystitis)
NCT04187144
Data reported:
Q2 2023
Penmenvy (MenABCWY vaccine)
In February 2025, the US FDA approved Penmenvy (Meningococcal Groups A, B, C,
W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine
targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y)
which commonly cause invasive meningococcal disease (IMD).
In April 2025, the ACIP voted to recommend its use as part of the US
adolescent meningococcal vaccination schedule. GSK is working to fulfil all
post-marketing requirements.
GSK's 5-in-1 meningococcal groups A, B, C, W, and Y (MenABCWY) vaccine
combines the antigenic components of its two well-established licensed
meningococcal vaccines - Bexsero (Meningococcal Group B Vaccine) and Menveo
(Meningococcal Groups A, C, Y, and W-135 Vaccine). Its safety data
demonstrates a safety profile consistent with these two vaccines. The
protection offered by Penmenvy aims to reduce the number of injections,
simplifying immunisation and potentially increasing series completion and
vaccination coverage of adolescents and young adults in the United States.
Key trials for Penmenvy:
Trial name (population) Phase Design Timeline Status
MenABCWY - 019 IIIb A randomised, controlled, observer-blind trial to evaluate safety and Trial start: Complete; primary endpoints met
immunogenicity of GSK's meningococcal ABCWY vaccine when administered in
healthy adolescents and adults, previously primed with meningococcal ACWY Q1 2021
vaccine
NCT04707391
Data reported:
Q1 2024
MenABCWY - V72 72 III A randomised, controlled, observer-blind trial to demonstrate effectiveness, Trial start: Complete; primary endpoints met
immunogenicity, and safety of GSK's meningococcal Group B and combined ABCWY
vaccines when administered to healthy adolescents and young adults Q3 2020
NCT04502693
Data reported:
Q1 2023
Reporting definitions
CAGR (Compound annual growth rate)
CAGR is defined as the compound annual growth rate and shows the annualised
average rate for growth in sales and core operating profit between 2021 to
2026, assuming growth takes place at an exponentially compounded rate during
those years.
CER and AER growth
In order to illustrate underlying performance, it is the Group's practice to
discuss its results in terms of constant exchange rate (CER) growth. This
represents growth calculated as if the exchange rates used to determine the
results of overseas companies in Sterling had remained unchanged from those
used in the comparative period. CER% represents growth at constant exchange
rates. For those countries which qualify as hyperinflationary as defined by
the criteria set out in IAS 29 'Financial Reporting in Hyperinflationary
Economies' (Argentina and Turkey) CER growth is adjusted using a more
appropriate exchange rate where the impact is significant, reflecting
depreciation of their respective currencies in order to provide comparability
and not to distort CER growth rates.
AER% represents growth at actual exchange rates.
Core Earnings per share
Unless otherwise stated, Core earnings per share refers to Core basic earnings
per share.
Core Operating Margin
Core Operating margin is Core operating profit divided by turnover.
Free cash flow
Free cash flow is defined as the net cash inflow/outflow from operating
activities less capital expenditure on property, plant and equipment and
intangible assets, contingent consideration payments, net finance costs, and
dividends paid to non-controlling interests, contributions from
non-controlling interests plus proceeds from the sale of property, plant and
equipment and intangible assets, and dividends received from joint ventures
and associates. The measure is used by management as it is considered a good
indicator of net cash generated from business activities (excluding any cash
flows arising from equity investments, business acquisitions or disposals and
changes in the level of borrowing) available to pay shareholders dividends and
to fund strategic plans. Free cash flow growth is calculated on a reported
basis. A reconciliation of net cash inflow from operations to free cash flow
from operations is set out on page 35.
Free cash flow conversion
Free cash flow conversion is free cash flow from operations as a percentage of
profit attributable to shareholders.
General Medicines
General Medicines are usually prescribed in the primary care or community
settings by general healthcare practitioners. For GSK, this includes medicines
for inhaled respiratory, dermatology, antibiotics and other diseases.
Non-controlling interest
Non-controlling interest is the equity in a subsidiary not attributable,
directly or indirectly, to a parent.
Percentage points
Percentage points of growth which is abbreviated to ppts.
RAR (Returns and Rebates)
GSK sells to customers both commercial and government mandated contracts with
reimbursement arrangements that include rebates, chargebacks and a right of
return for certain pharmaceutical products principally in the US. Revenue
recognition reflects gross-to-net sales adjustments as a result. These
adjustments are known as the RAR accruals and are a source of significant
estimation uncertainty and fluctuation which can have a material impact on
reported revenue from one accounting period to the next.
Risk adjusted sales
Pipeline risk-adjusted sales are based on the latest internal estimate of the
probability of technical and regulatory success for each asset in development.
Specialty Medicines
Specialty Medicines are typically prescription medicines used to treat complex
or rare chronic conditions. For GSK, this comprises medicines for infectious
diseases, HIV, Respiratory, Immunology and Inflammation, and Oncology.
Total Net debt
Net debt is defined as total borrowings less cash, cash equivalents, liquid
investments, and short-term loans to third parties that are subject to an
insignificant risk of change in value. The measure is used by management as it
is considered a good indicator of GSK's ability to meet its financial
commitments and the strength of its balance sheet.
Total and Core results
Total reported results represent the Group's overall performance. GSK uses a
number of non-IFRS measures to report the performance of its business. Core
results and other non-IFRS measures may be considered in addition to, but not
as a substitute for or superior to, information presented in accordance with
IFRS. Core results are defined on page 17 and other non-IFRS measures are
defined in pages 44 and 45.
Total Operating Margin
Total Operating margin is Total operating profit divided by turnover.
Total Earnings per share
Unless otherwise stated, Total earnings per share refers to Total basic
earnings per share.
Working capital
Working capital represents inventory and trade receivables less trade
payables.
Brand names and partner acknowledgements: brand names appearing in italics
throughout this document are trademarks of GSK or associated companies or used
under licence by the Group.
Guidance and Outlooks, assumptions and cautionary statements
2025 Guidance
GSK affirms its full-year 2025 guidance at constant exchange rates (CER).
GSK expects its turnover to increase between 3 to 5 per cent and Core
operating profit to increase between 6 to 8 per cent. Core earnings per share
is expected to increase between 6 to 8 per cent.
The Core earnings per share guidance includes the implementation of the £2
billion share buyback programme to the end of Q2 2026.
The Group has made planning assumptions that we expect turnover for Specialty
Medicines to increase by a low double-digit per cent, Vaccines to decrease by
a low-single digit per cent, and General Medicines to be broadly stable.
Tariffs
GSK notes that the US Administration has initiated an investigation under
Section 232 of the Trade Expansion Act to determine the effects on national
security of imports of pharmaceutical products. The company is well positioned
to respond to the potential financial impact of sector-specific tariffs,
should they be implemented, with mitigation options identified in the supply
chain and productivity initiatives. The company will continue to monitor and
review developments related to this situation.
2021-2026 and 2031 Outlooks
In February 2025 GSK set out improved outlooks for 2031. Please see 2024 full
year and fourth quarter results on gsk.com
(https://www.gsk.com/media/11776/fy-2024-results-announcement.pdf) (1).
Assumptions and basis of preparation related to 2025 Guidance, 2021-26 and
2031 Outlooks
In outlining the guidance for 2025, and outlooks for the period 2021-26 and
for 2031, the Group has made certain assumptions about the macro-economic
environment, the healthcare sector (including regarding existing and possible
additional governmental legislative and regulatory reform), the different
markets and competitive landscape in which the Group operates and the delivery
of revenues and financial benefits from its current portfolio, its development
pipeline and restructuring programmes.
2025 Guidance
These planning assumptions as well as operating profit and earnings per share
guidance and dividend expectations assume no material interruptions to supply
of the Group's products, no material mergers, acquisitions or disposals, no
material litigation or investigation costs for the Company (save for those
that are already recognised or for which provisions have been made) and no
change in the Group's shareholdings in ViiV Healthcare. The assumptions also
assume no material changes in the healthcare environment or unexpected
significant changes in pricing or trade policies as a result of government or
competitor action. The 2025 guidance factors in all divestments and product
exits announced to date.
2021-26 and 2031 Outlooks
The assumptions for GSK's revenue, Core operating profit, Core operating
margin and cash flow outlooks, 2031 revenue outlook and margin expectations
through dolutegravir loss of exclusivity assume the delivery of revenues and
financial benefits from its current and development pipeline portfolio of
medicines and vaccines (which have been assessed for this purpose on a
risk-adjusted basis, as described further below); regulatory approvals of the
pipeline portfolio of medicines and vaccines that underlie these expectations
(which have also been assessed for this purpose on a risk-adjusted basis, as
described further below); no material interruptions to supply of the Group's
products; successful delivery of the ongoing and planned integration and
restructuring plans; no material mergers, acquisitions or disposals or other
material business development transactions; no material litigation or
investigation costs for the company (save for those that are already
recognised or for which provisions have been made); and no change in the
shareholdings in ViiV Healthcare. GSK assumes no premature loss of exclusivity
for key products over the period.
The assumptions for GSK's revenue, Core operating profit, Core operating
margin and cash flow outlooks, 2031 revenue outlook and margin expectations
through dolutegravir loss of exclusivity also factor in all divestments and
product exits announced to date as well as material costs for investment in
new product launches and R&D. Risk- adjusted sales includes sales for
potential planned launches which are risk-adjusted based on the latest
internal estimate of the probability of technical and regulatory success for
each asset in development.
Notwithstanding our guidance, outlooks and expectations, there is still
uncertainty as to whether our assumptions, guidance, outlooks and expectations
will be achieved.
All outlook statements are given on a constant currency basis and use 2024
average exchange rates as a base (£1/$1.28, £1/€1.18, £1/Yen 193).
(1) https://www.gsk.com/media/11776/fy-2024-results-announcement.pdf
(https://www.gsk.com/media/11776/fy-2024-results-announcement.pdf)
Assumptions and cautionary statement regarding forward-looking statements
The Group's management believes that the assumptions outlined above are
reasonable, and that the guidance, outlooks, and expectations described in
this report are achievable based on those assumptions. However, given the
forward-looking nature of these guidance, outlooks, and expectations, they are
subject to greater uncertainty, including potential material impacts if the
above assumptions are not realised, and other material impacts related to
foreign exchange fluctuations, macro-economic activity, the impact of
outbreaks, epidemics or pandemics, changes in legislation, regulation,
government actions or intellectual property protection, product development
and approvals, actions by our competitors, and other risks inherent to the
industries in which we operate.
This document contains statements that are, or may be deemed to be,
"forward-looking statements". Forward-looking statements give the Group's
current expectations or forecasts of future events. An investor can identify
these statements by the fact that they do not relate strictly to historical or
current facts. They use words such as 'anticipate', 'estimate', 'expect',
'intend', 'will', 'project', 'plan', 'believe', 'target' and other words and
terms of similar meaning in connection with any discussion of future operating
or financial performance. In particular, these include statements relating to
future actions, prospective products or product approvals, future performance
or results of current and anticipated products, sales efforts, expenses, the
outcome of contingencies such as legal proceedings, dividend payments and
financial results. Other than in accordance with its legal or regulatory
obligations (including under the Market Abuse Regulation, the UK Listing Rules
and the Disclosure Guidance and Transparency Rules of the Financial Conduct
Authority), the Group undertakes no obligation to update any forward-looking
statements, whether as a result of new information, future events or
otherwise. The reader should, however, consult any additional disclosures that
the Group may make in any documents which it publishes and/or files with the
SEC. All readers, wherever located, should take note of these disclosures.
Accordingly, no assurance can be given that any particular expectation will be
met and investors are cautioned not to place undue reliance on the
forward-looking statements.
All guidance, outlooks and expectations should be read together with the
guidance and outlooks, assumptions and cautionary statements in this Q1 2025
earnings release and in the Group's 2024 Annual Report on Form 20-F.
Forward-looking statements are subject to assumptions, inherent risks and
uncertainties, many of which relate to factors that are beyond the Group's
control or precise estimate. The Group cautions investors that a number of
important factors, including those in this document, could cause actual
results to differ materially from those expressed or implied in any
forward-looking statement. Such factors include, but are not limited to, those
discussed under Item 3.D 'Risk Factors' in the Group's Annual Report on Form
20-F for 2024. Any forward-looking statements made by or on behalf of the
Group speak only as of the date they are made and are based upon the knowledge
and information available to the Directors on the date of this report.
Independent review report to GSK plc
Conclusion
We have been engaged by GSK plc ("the company") to review the condensed
financial information in the Results Announcement of the company for the three
months ended 31 March 2025.
The condensed financial information comprises:
• the income statement and statement of comprehensive income for the three month
period ended 31 March 2025 on page 22 and 23;
• the balance sheet as at 31 March 2025 on page 24;
• the statement of changes in equity for the three-month period then ended on
page 25;
• the cash flow statement for the three-month period then ended on page 26; and
• the accounting policies and basis of preparation and the explanatory notes to
the condensed financial information on pages 27 to 35 that have been prepared
applying consistent accounting policies to those applied by GSK plc and its
subsidiaries ("the Group") in the Annual Report 2024, which was prepared in
accordance with UK-adopted international accounting standards in conformity
with the requirements of the Companies Act 2006 and the International
Financial Reporting Standards (IFRS) as issued by the International Accounting
Standards Boards (IASB).
Based on our review, nothing has come to our attention that causes us to
believe that the condensed financial information in the Results Announcement
for the three months ended 31 March 2025 is not prepared, in all material
respects in accordance with the accounting policies set out in the accounting
policies and basis of preparation section on page 32.
Basis for Conclusion
We conducted our review in accordance with International Standard on Review
Engagements (UK) 2410 "Review of Interim Financial Information Performed by
the Independent Auditor of the Entity" issued by the Financial Reporting
Council for use in the United Kingdom (ISRE (UK) 2410). A review of interim
financial information consists of making inquiries, primarily of persons
responsible for financial and accounting matters, and applying analytical and
other review procedures. A review is substantially less in scope than an audit
conducted in accordance with International Standards on Auditing (UK) and
consequently does not enable us to obtain assurance that we would become aware
of all significant matters that might be identified in an audit. Accordingly,
we do not express an audit opinion.
As disclosed on page 32, the annual financial statements of the company are
prepared in accordance with United Kingdom adopted international accounting
standards. The condensed set of financial information included in this Results
Announcement have been prepared in accordance with the accounting policies set
out in the accounting policies and basis of preparation section on page 32.
Conclusion Relating to Going Concern
Based on our review procedures, which are less extensive than those performed
in an audit as described in the Basis for Conclusion section of this report,
nothing has come to our attention to suggest that the directors have
inappropriately adopted the going concern basis of accounting or that the
directors have identified material uncertainties relating to going concern
that are not appropriately disclosed.
This Conclusion is based on the review procedures performed in accordance with
ISRE (UK) 2410, however future events or conditions may cause the entity to
cease to continue as a going concern.
Responsibilities of the directors
The directors are responsible for preparing the Results Announcement of the
company in accordance with the Disclosure Guidance and Transparency Rules of
the United Kingdom's Financial Conduct Authority.
In preparing the Results Announcement, the directors are responsible for
assessing the company's ability to continue as a going concern, disclosing as
applicable, matters related to going concern and using the going concern basis
of accounting unless the directors either intend to liquidate the company or
to cease operations, or have no realistic alternative but to do so.
Auditor's Responsibilities for the review of the financial information
In reviewing the Results Announcement, we are responsible for expressing to
the company a conclusion on the condensed financial information in the Results
Announcement based on our review. Our Conclusion, including our Conclusion
Relating to Going Concern, are based on procedures that are less extensive
than audit procedures, as described in the Basis for Conclusion paragraph of
this report.
Use of our report
This report is made solely to the company in accordance with ISRE (UK) 2410.
Our work has been undertaken so that we might state to the company those
matters we are required to state to it in an independent review report and for
no other purpose. To the fullest extent permitted by law, we do not accept or
assume responsibility to anyone other than the company, for our review work,
for this report, or for the conclusions we have formed.
Deloitte LLP
Statutory Auditor
London, United Kingdom
29 April 2025
Glossary
Terms used in the Announcement Brief description
2 L 2nd line
ACIP Advisory Committee on Immunization Practices
ADC Antibody-drug-conjugates
ADP Adenosine diphosphate
AMP Average manufacturer price
ASO Antisense oligonucleotide
AS03 Adjuvant system 03
Bnab Broadly neutralising antibody
CCL Contingent consideration liability
CDC Centre for Disease Control and Prevention
CMS Centre for Medicare & Medicaid Services
COPD Chronic obstructive pulmonary disease
CROI Conference on Retroviruses and Opportunistic Infections
CRSwNP Chronic rhinosinusitis with nasal polyps
DTG Dolutegravir
EGPA Eosinophilic granulomatosis with polyangiitis
ESOP Employee share ownership plan
GIST Gastrointestinal stromal tumours
HBV Hepatitis B virus
HES Hypereosinophilic syndrome
IBATi Ileal bile acid transporter inhibitor
Insti Integrase nuclear strand transfer inhibitors
IRA Inflation Reduction Act
JAK Janus kinase inhibitor
JAK1/JAK2 and ACVR1 once a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor
LA Long acting includes Cabenuva and Apretude
MAPS Multi antigen presenting system
MDS Myelodysplastic Syndromes
MGMT glioblastoma methylated DNA protein cysteine methyltransferase
MMR/V Measles, mumps, rubella and varicella
mRNA messenger ribonucleic acid
OA Older adults
OECD Organisation for Economic Co-operation and Development
Oral 2DR Oral 2 drug regimen includes Dovato and Juluca
PARP a Poly ADP ribose polymerase
PD-1 a programmed death receptor-1 blocking antibody
PK Pharmacokinetics
PYS Peak year sales
Q4M every 4 months
Q6M every 6 months
RCC Refractory chronic cough
RNS Regulatory news service
RSV Respiratory syncytial virus
SCLC small cell lung cancer
SITT Single inhaler triple therapy
TIGIT T cell immunoreceptor with Ig and ITIM domains
TIM3 T-cell membrane protein-3
TSLP Long-acting anti-thymic stromal lymphopoietin monoclonal
ULA Ultra long acting
uUTIs uncomplicated urinary tract infections
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