REG - GSK PLC - 2nd Quarter Results
31/07/2024 07:00
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RNS Number : 4712Y GSK PLC 31 July 2024
GSK delivers continued strong performance and upgrades 2024 guidance
Broad-based performance drives sales, core profit and core EPS growth:
• Total Q2 2024 sales £7.9 billion +13%
• Vaccines sales +1%, +3% ex COVID. Shingrix £0.8 billion -4%
• Specialty Medicines sales +22%. HIV sales +13%. Oncology sales more than
doubled at £0.4 billion
• General Medicines sales +12%. Trelegy £0.8 billion +41%
• Total operating profit -22% and Total EPS -27% for Q2 2024 primarily reflected
higher charges for CCL(1) remeasurements driven by improved longer term HIV
prospects and foreign currency movements
• Core operating profit +18% (with further positive impact of 3% ex COVID) and
Core EPS +13% (with further positive impact of 4% ex COVID). This reflected
continued leverage from strong sales and favourable product and regional mix,
partly offset by continued increased investment in R&D and growth assets,
and lower royalty income
• Cash generated from operations in the quarter £1.7 billion with Free cash
flow of £0.3 billion
(Financial Performance - Q2 2024 results unless otherwise stated, growth % and
commentary at CER, ex COVID is excluding COVID-19 solutions as defined on page
60).
Q2 2024 Year to date
£m % AER % CER £m % AER % CER
Turnover 7,884 10 13 15,247 8 12
Turnover ex COVID 7,884 10 13 15,246 9 13
Total operating profit 1,646 (23) (22) 3,136 (26) (20)
Total operating margin % 20.9% (8.9ppts) (9.1ppts) 20.6% (9.3ppts) (8.4ppts)
Total EPS 28.8p (28) (27) 54.5p (29) (24)
Core operating profit 2,513 16 18 4,956 16 22
Core operating margin % 31.9% 1.6ppts 1.3ppts 32.5% 2.3ppts 2.9ppts
Core EPS 43.4p 12 13 86.5p 14 20
Cash generated from operations 1,650 2 2,776 46
Continued R&D progress with growth prospects strengthened in all key
therapeutic areas:
• Infectious Diseases: FDA approval for Arexvy in adults aged 50-59 at increased
risk from RSV; filings accepted for meningitis (ABCWY) vaccine
• HIV: regimen selection for CAB-ULA, and data for new 3rd generation integrase
inhibitor, support portfolio progression and long-term growth outlooks
• Respiratory/Immunology: Pivotal data for depemokimab (SWIFT 1/2) support
filings as first ultra-long-acting biologic for severe asthma
• Oncology: Pivotal data for Blenrep (DREAMM-8) support regulatory submissions
(EU filed; US H2 2024). Data supporting expanded use of Jemperli in patients
with endometrial cancer presented (regulatory decisions expected H2 2024).
Approval for Omjjara received in Japan
2024 guidance upgraded; Q2 2024 dividend of 15p declared continue to expect
60p full year dividend:
• 2024 turnover growth increase of 7% to 9% (previously 5% to 7%); Core
operating profit growth of 11% to 13% (previously 9% to 11%); Core EPS growth
of 10% to 12% (previously 8% to 10%)
Guidance all at CER and excluding COVID-19 solutions
Emma Walmsley, Chief Executive Officer, GSK:
"GSK's momentum this year continues with excellent second quarter performance,
reflecting strong operational execution and the strengthening breadth of our
portfolio to both prevent and treat disease. Q2 sales grew in all areas, with
Specialty Medicines in particular benefitting from new product launches in
oncology and HIV. In R&D, so far this year, we have secured approvals or
filings for 10 major opportunities and reported positive data from 7 phase III
trials. We have also strengthened capabilities in key technology platforms and
completed investments to develop new mRNA vaccines, ultra-long-acting HIV
medicines and a promising new medicine for severe asthma. All this supports
our future growth and confidence to bring meaningful innovation to patients".
The Total results are presented in summary above and on page 8 and Core
results reconciliations are presented on pages 20 and 23. 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 page 60: Core results, £% or AER% growth,
CER% growth,COVID-19 solutions, turnover excluding COVID-19 solutions; and
other non-IFRS measures. GSK provides guidance on a Core results basis only,
for the reasons set out on page 18. 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
62. (1) Contingent consideration liability is abbreviated to CCL.
2024 Guidance
GSK revises its full-year guidance at constant exchange rates (CER). All
guidance, expectations and full-year growth rates exclude any contributions
from COVID-19 solutions.
GSK delivered a strong first half 2024 performance with excellent business
momentum, including increased sales growth of Specialty Medicines,
particularly reflecting successful new launches in Oncology and for
long-acting HIV medicines. General Medicines, including Trelegy, also
continued to perform better than expected. Sales are now expected to grow
between 7 to 9 per cent at CER (previously "upper part of the range of between
5 to 7 per cent increase"). Improved sales performances in Specialty and
General Medicines are expected to more than offset lower sales growth of
Vaccines this year, which reflects revised recommendations for RSV
vaccinations issued in June by the US Advisory Committee on Immunization
Practices.
All Guidance excludes the contributions of COVID-19 solutions New 2024 guidance at CER Previous 2024 guidance at CER
Turnover Increase between 7% to 9% Increase towards the upper part of the range of between 5% to 7%
Core operating profit Increase between 11% to 13% Increase between 9% to 11%
Core earnings per share Increase between 10% to 12% Increase between 8% to 10%
Growth in the second half of 2024 will be impacted by the annualisation of
product launches and stocking impacts as compared with the same period last
year, particularly in Vaccines and Oncology.
This guidance continues to be supported by the following revised turnover
expectations for full-year 2024 at CER:
All turnover expectations exclude the contributions of COVID-19 solutions New 2024 guidance at CER Previous 2024 guidance at CER
Vaccines Increase low to mid-single digit per cent in turnover Increase of high single-digit to low double-digit per cent in turnover
Specialty Medicines Increase mid to high teens per cent in turnover Increase of low double-digit per cent in turnover
General Medicines Increase low to mid-single digit per cent in turnover Decrease of mid-single digit per cent in turnover
Core Operating profit is now expected to grow between 11 to 13 per cent at CER
(previously 9 to 11 per cent increase), despite a 6 percentage point impact to
Operating Profit growth following the loss of the majority of Gardasil
royalties effective from the beginning of 2024. SG&A is expected to grow
low-single digits, with effective cost control driving operating leverage and
further margin improvements. R&D expenditure is expected to increase
slightly below sales growth and for royalty income to be around £600 million
for the full year.
Core Earnings per share is now expected to increase between 10 to 12 per cent
at CER, (previously 8 to 10 per cent increase) reflecting continued higher
operating profit with lower net finance costs. Expectations for
non-controlling interests remain unchanged relative to 2023, and GSK continues
to anticipate an increase in the Core effective tax rate to around 17% for the
full year following implementation of new global minimum corporate income tax
rules which came into effect from 1 January 2024 in line with the Organisation
for Economic Co-Operation and Development 'Pillar 2' model framework.
Additional commentary
Dividend policy
The Dividend policy and the expected pay-out ratio remain unchanged.
Consistent with this, and reflecting strong business performance during the
quarter, GSK expects to declare a dividend for Q2 2024 of 15p per share and
for the full year 2024 60p.
COVID-19 solutions
For the full year 2024, GSK does not anticipate any further COVID-19
pandemic-related sales or operating profit. Consequently, and in comparison to
2023, it is anticipated that the full year growth in sales and Core operating
profit will be adversely impacted by one and two percentage points,
respectively.
Exchange rates
If exchange rates were to hold at the closing rates on 30 June 2024
($1.27/£1, €1.18/£1 and Yen 203/£1) for the rest of 2024, the estimated
impact on 2024 Sterling turnover growth for GSK would be -4% and if exchange
gains or losses were recognised at the same level as in 2023, the estimated
impact on 2024 Sterling Core Operating Profit growth for GSK would be -6%.
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 ET at 7am) on
31 July 2024. 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.
Performance: turnover
Turnover Q2 2024 Year to date
£m Growth Growth £m Growth Growth
AER% CER% AER% CER%
Shingles 832 (5) (4) 1,777 4 7
Meningitis 323 21 24 622 14 17
RSV (Arexvy) 62 - - 244 - -
Influenza 7 (70) (65) 20 (43) (40)
Established Vaccines 775 (5) (2) 1,613 (1) 2
Vaccines ex COVID 1,999 1 3 4,276 9 12
Pandemic vaccines - (100) (100) - (100) (100)
Vaccines 1,999 (1) 1 4,276 5 8
HIV 1,757 11 13 3,370 11 14
Respiratory/Immunology and Other 911 15 18 1,546 11 15
Oncology 356 >100 >100 629 >100 >100
Specialty Medicines ex COVID 3,024 20 22 5,545 17 21
Xevudy - (100) (100) 1 (97) (97)
Specialty Medicines 3,024 20 22 5,546 17 20
Respiratory 2,065 15 18 3,790 6 10
Other General Medicines 796 (5) (1) 1,635 (6) (2)
General Medicines 2,861 9 12 5,425 2 6
Total 7,884 10 13 15,247 8 12
Total ex COVID 7,884 10 13 15,246 9 13
By Region:
US 4,147 15 17 7,736 12 15
Europe 1,672 2 3 3,293 (2) -
International 2,065 7 13 4,218 8 15
Total 7,884 10 13 15,247 8 12
Turnover ex COVID is excluding COVID-19 solutions during the years from 2020
to 2023 and is a non-IFRS measure defined on page 60 with the reconciliation
to the IFRS measure Turnover included in the table above. Financial
Performance - Q2 2024 results unless otherwise stated, growth % and commentary
at CER.
Q2 2024 Year to date
£m AER CER £m AER CER
Vaccines Total 1,999 (1%) 1% 4,276 5% 8%
Excluding COVID 1,999 1% 3% 4,276 9% 12%
In Q2 2024, Vaccine sales growth was driven by increased demand for
Meningitis vaccines and uptake of Arexvy in the US in line with expected
waning seasonal demand. Shingrix grew YTD but declined in the quarter as
channel inventory reductions, changes in retail vaccine prioritisation and
lower demand in the US more than offset growth in International and Europe.
Both the quarter and YTD growth comparators were adversely impacted due to
COVID-19 solution sales in 2023.
Shingles 832 (5%) (4%) 1,777 4% 7%
Sales of Shingrix, a vaccine against herpes zoster (shingles), declined in the
quarter, while continuing to grow YTD.
In the US, sales in the quarter decreased by 36% at AER and CER reflecting
channel inventory reductions and changes in retail vaccine prioritisation in
part due to a transition to a new CMS(1) rule that changed how pharmacies
process reimbursements from payers. In addition lower demand was driven by
challenges activating harder-to-reach consumers which remains a priority with
the US cumulative immunisation penetration rate at the end of Q1 2024 reaching
37% of the more than 120 million US adults(2) currently recommended to receive
Shingrix, up six percentage points(3) since the end of Q1 2023.
Shingrix grew significantly in International in the quarter and YTD, driven by
a national immunisation programme in Australia and regional funding in Japan
together with supply to our co-promotion partner in China despite phasing of
some expected sales into Q3. In Europe, Shingrix grew in the quarter and YTD
from expanded public funding, partly offset by declining demand in Germany.
Markets outside the US now represent 64% of Q2 2024 global sales (Q2 2023:
46%), with Shingrix launched in 45 countries. The majority of these markets
have average cumulative immunisation rates below 5%.
Footnotes:
(1) Centers for Medicare & Medicaid Services
(2) United States Census Bureau, International Database, Year 2024
(3) Reflects latest United States Census Bureau data and delivery orders
Q2 2024 Year to date
£m AER CER £m AER CER
Meningitis 323 21% 24% 622 14% 17%
In Q2 2024 and YTD, both key Meningitis vaccines grew double-digit. Bexsero, a
vaccine against meningitis B, grew primarily reflecting favourable pricing mix
in the US, recommendation in Germany, increased demand in Australian regional
immunisation programmes and launch in Vietnam, partly offset by tender phasing
in Europe. Menveo, a vaccine against meningitis ACWY, grew due to favourable
delivery timing in International and the Center for Disease Control (CDC)
purchasing patterns in the US.
RSV (Arexvy) 62 - - 244 - -
Arexvy, a respiratory syncytial virus (RSV) vaccine for older adults,
continued to demonstrate consumer uptake and leading market share. In the US,
Q2 2024 sales were £56 million, with the overwhelming majority of doses
administered in the retail setting. Arexvy maintained around two-thirds of the
retail vaccination share, while demand decreased overall in line with
anticipated respiratory virus seasonality patterns. Nearly eight million of
the 85 million US adults(1) aged 60 and older have been protected by Arexvy
since the launch in Q3 2023. The performance YTD also reflected initial tender
deliveries in Saudi Arabia, continued consumer uptake in Canada and new launch
inventory build in Brazil. While Arexvy is approved in 49 markets globally, 12
countries had national RSV vaccination recommendations for older adults and 5,
including the US, had reimbursement programmes in place at the quarter end.
Established Vaccines 775 (5%) (2%) 1,613 (1%) 2%
Established Vaccines declined in Q2 2024, reflecting unfavourable CDC
stockpile movements for Rotarix and Infanrix/Pediarix in the US, partly offset
by increased supply of measles, mumps, rubella, and varicella (MMRV) vaccines
and higher demand for Infanrix/Pediarix in International. YTD sales were also
impacted by competitive pressure in the US for Infanrix/ Pediarix.
Specialty Medicines Total 3,024 20% 22% 5,546 17% 20%
Excluding COVID 3,024 20% 22% 5,545 17% 21%
Specialty Medicines sales increased by double digits in the quarter,
reflecting continued growth across disease areas, with strong performances in
HIV, Respiratory/Immunology and Oncology.
HIV 1,757 11% 13% 3,370 11% 14%
In Q2 2024 HIV delivered 13% growth, which was primarily driven by a 2
percentage point increase in market share versus Q2 2023 as a result of strong
patient demand for Oral 2DR (Dovato, Juluca) and long-acting medicines
(Cabenuva, Apretude). The YTD growth was also primarily driven by strong
patient demand, whilst benefitting from favourable pricing, including the
positive impact from channel mix including adjustments to returns and
rebates.
Oral 2DR 727 23% 25% 1,367 20% 23%
Oral 2-drug regimens sales in the quarter were £727 million, which now
represents 41% of the total HIV portfolio. Dovato continues to be the highest
selling product in the HIV portfolio with sales of £551 million in the
quarter and growing 30% at CER versus Q2 2023.
Long-Acting Medicines 317 50% 52% 584 61% 65%
Long-Acting Medicine sales in the quarter now represent 18% of the total HIV
portfolio compared to 13% for Q2 2023 and contributed more than 50% of the
total HIV growth. Cabenuva sales in Q2 2024 were £245 million and growing 42%
at CER driven by strong patient demand. Apretude sales in Q2 2024 were £72
million, growing £36 million at AER; £37 million at CER compared to Q2 2023.
Respiratory/Immunology and Other 911 15% 18% 1,546 11% 15%
Sales primarily comprise contributions from Nucala in respiratory and Benlysta
in immunology. In Q2 2024, sales growth for Nucala and Benlysta increased,
driven by patient demand globally across US, European and International
markets. YTD performance was slightly lower due to US Q1 2024 performance,
where the growth of the medicines remained broadly stable due to the impact of
channel inventory reduction following a channel inventory build in Q4 2023.
Nucala 482 14% 17% 856 11% 15%
Nucala, is an IL-5 antagonist monoclonal antibody treatment for severe asthma,
with additional indications including chronic rhinosinusitis with nasal
polyps, eosinophilic granulomatosis with polyangiitis (EGPA), and
hypereosinophilic syndrome (HES). In Q2 2024, sales growth was driven by
strong performances globally across all regions, which reflected higher
patient demand for treatments addressing eosinophilic-led disease.
Footnote:
(1) United States Census Bureau, International Database, Year 2024
Q2 2024 Year to date
£m AER CER £m AER CER
Benlysta 418 17% 20% 678 11% 15%
Benlysta, a monoclonal antibody treatment for Lupus, continues to grow
consistently in Q2 2024, representing strong demand and volume growth in US,
European and International regions, with bio-penetration rates having
increased across many markets.
Oncology 356 >100% >100% 629 >100% >100%
In Q2 2024, Oncology sales growth increased driven by strong patient growth
for Zejula, a PARP(1), Jemperli, a PD-1(2) blocking antibody, and
Ojjaara/Omjjara, a daily JAK1/JAK2 and ACVR1(3) inhibitor. Jemperli, a
medicine for front-line treatment in combination with chemotherapy for
patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,
continued to grow strongly and delivered sales of £108 million in the
quarter. Ojjaara/Omjjara, a treatment for myelofibrosis patients with anaemia,
launched in the US in Q3 2023 and in the UK and Germany in Q1 2024, has seen
strong uptake since launch and delivered £85 million of sales in the quarter.
Zejula 165 41% 44% 306 32% 35%
Zejula delivered continued double-digit sales growth in the quarter and YTD,
with strong performances across all regions. Growth globally was sustained
with increased patient demand and higher volumes, further enhanced by positive
price impacts in the US including impacts from launch of the tablet
formulation in the US in Q3 2023.
General Medicines 2,861 9% 12% 5,425 2% 6%
Sales include contributions from both the Respiratory and Other General
Medicine portfolios. In Q2 2024, sales growth increased primarily driven by
Trelegy, a chronic obstructive pulmonary disease (COPD) and asthma medicine,
with strong demand across all regions and pricing benefits from channel and
segment mix and adjustments to returns and rebates in the US. Performance was
adversely impacted by the removal of the Average Manufacturer Price (AMP) cap
on Medicaid drug prices in the US. This removal impacted Advair, Flovent, and
Lamictal due to significant pricing reductions, reduced commercial
contracting, and the decision to discontinue branded Flovent. However, this
has been fully offset by the increased use of authorised generic versions of
Advair and Flovent while, significantly, continuing to provide access to
patients.
Respiratory 2,065 15% 18% 3,790 6% 10%
In Q2 2024 and YTD, sales growth reflected Trelegy's strong performance in all
regions and the increased demand for Anoro, particularly in Europe and
International. Seretide/Advair and other respiratory declined due to the
impact of continued generic erosion in Europe and International markets. As
mentioned above, in the US adverse impacts from the removal of the AMP cap
were fully offset by the increased use of authorised generic versions of
Advair and Flovent, providing access to medicines for patients.
Trelegy 842 38% 41% 1,433 33% 38%
Trelegy is the most prescribed single inhaler triple therapy (SITT) treatment
worldwide for COPD and asthma. In Q2 2024 sales growth further increased with
strong growth across all regions, reflecting patient demand, single-inhaled
triple therapy class growth, and increased market share. Around half of the
growth in the quarter was driven by price benefit from channel and segment mix
as well as adjustments to returns and rebates.
Seretide/Advair 298 (7%) (5%) 580 (12%) (9%)
Seretide/Advair is a combination treatment used to treat asthma and COPD. In
Q2 2024, the decrease in sales reflected continued generic erosion from
competitor products in Europe and International. Broadly stable performance in
the US reflected impacts of the removal of the AMP cap on Medicaid drug prices
in the US on branded Advair, offset by the increased use of authorised generic
versions.
Other General Medicines 796 (5%) (1%) 1,635 (6%) (2%)
The performance in Q2 2024 and YTD was adversely impacted by ongoing generic
competition globally, and continued impacts to Lamictal's performance in the
US from the removal of the AMP cap on Medicaid drug prices. This performance
was partially offset by increased antibiotic growth in International markets.
Footnotes:
(1) PARP: a Poly ADP ribose polymerase
(2) PD-1: a programmed death receptor-1 blocking antibody
(3) JAK1/JAK2 and ACVR1: once a-day, oral JAK1/JAK2 and activin A receptor type 1
(ACVR1) inhibitor
By Region
Q2 2024 Year to date
£m AER CER £m AER CER
US Total 4,147 15% 17% 7,736 12% 15%
Excluding COVID 4,147 15% 17% 7,736 12% 15%
Vaccine sales decreased in Q2 2024 driven by Shingrix reflecting channel
inventory reductions, changes in retail vaccine prioritisation and lower
demand driven by challenges activating harder-to-reach customers which remains
a priority. In addition, adverse CDC stockpile movements impacted Established
Vaccines. This was partly offset by Arexvy continued uptake and leading market
share. YTD performance also reflected the strong Shingrix comparator of 2023.
In Q2 2024, sales growth of Specialty Medicines increased, following adverse
inventory channel impacts in Q1 2024 in Nucala and Benlysta in the US.
Specialty Medicines continued to grow YTD driven by Oncology and HIV
performance and continued growth in Nucala and Benlysta.
General Medicine's growth in Q2 2024 and YTD was primarily driven by increased
demand for Trelegy, with strong volume growth driven by patient demand, growth
of the SITT market, and price benefits from channel mix and adjustments to
returns and rebates. Performance continues to be impacted following the
removal of the AMP cap on Medicaid drug prices, which particularly impacted
Advair, Flovent and Lamictal. However this was fully offset by the increased
use of authorised generic versions of Advair and Flovent, providing access to
medicines for patients.
Europe Total 1,672 2% 3% 3,293 (2%) -
Excluding COVID 1,672 3% 5% 3,293 2% 4%
In Q2 2024 and YTD, Vaccine sales growth excluding COVID-19 solutions
reflected Shingrix growth across several markets following public funding
expansion and Bexsero recommendation in Germany partly offset by lower
Shingrix demand in Germany and decreased tender sales for Established Vaccines
and Bexsero.
Specialty Medicines sales grew in the quarter and YTD by a double-digit
percentage due to the performance in Oncology, Benlysta in immunology, and
Nucala in respiratory including the impact of new indication launches. HIV
growth continued in the quarter and YTD at a high single digit percentage.
General Medicines sales were broadly stable in the quarter and YTD, reflecting
strong growth in Trelegy and Anoro, offset by a decrease in other respiratory
medicines.
International Total 2,065 7% 13% 4,218 8% 15%
Excluding COVID 2,065 8% 14% 4,217 10% 16%
In Q2 2024, sales excluding COVID-19 solutions increased 8% at AER and 14% at
CER, which reflected year-on-year exchange movements in several International
markets compared to Q2 2023.
Vaccines' double-digit growth in Q2 2024 and YTD was driven by the expansion
of public funding for Shingrix in Australia and Japan and supply to our
co-promotion partner in China together with increased supply and higher demand
for Established vaccines.
Specialty Medicine's double-digit growth in the quarter and YTD was driven by
HIV, Nucala in Respiratory, Benlysta in Immunology, and Zejula in Oncology.
General Medicines sales grew low single digit percentage in the quarter and
YTD, with Trelegy and Antibiotics delivering growth offset by a decrease in
other respiratory medicines.
Financial performance
Total Results Q2 2024 Year to date
£m % AER % CER £m % AER % CER
Turnover 7,884 10 13 15,247 8 12
Cost of sales (2,122) 10 13 (4,092) 6 7
Selling, general and administration (2,465) 9 13 (4,552) 3 7
Research and development (1,477) 10 12 (2,911) 12 14
Royalty income 144 (36) (37) 295 (27) (27)
Other operating income/(expense) (318) (851)
Operating profit 1,646 (23) (22) 3,136 (26) (20)
Net finance expense (150) (1) 1 (284) (13) (12)
Share of after tax profit/(loss) of associates (1) (2)
and joint ventures
Profit before taxation 1,495 (25) (23) 2,850 (27) (21)
Taxation (191) (465)
Tax rate % 12.8% 16.3%
Profit after taxation 1,304 (25) (24) 2,385 (29) (23)
Profit attributable to non-controlling interests 131 166
Profit attributable to shareholders 1,173 2,219
1,304 (25) (24) 2,385 (29) (23)
Earnings per share 28.8p (28) (27) 54.5p (29) (24)
Financial Performance - Q2 2024 results unless otherwise stated, growth % and
commentary at CER.
Core results
Reconciliations between Total results and Core results for Q2 2024, Q2 2023,
H1 2024 and H1 2023 are set out on pages 20, 21, 23 and 24.
Q2 2024 Year to date
£m % AER % CER £m % AER % CER
Turnover 7,884 10 13 15,247 8 12
Cost of sales (1,877) 9 12 (3,610) 4 6
Selling, general and administration (2,223) 1 6 (4,202) (1) 2
Research and development (1,415) 8 9 (2,774) 9 12
Royalty income 144 (36) (37) 295 (27) (27)
Core operating profit 2,513 16 18 4,956 16 22
Core profit before taxation 2,364 17 19 4,674 19 25
Taxation (423) 34 36 (827) 34 41
Core profit after taxation 1,941 14 16 3,847 16 22
Core profit attributable to non-controlling 170 324
interests
Core profit attributable to shareholders 1,771 3,523
1,941 14 16 3,847 16 22
Core Earnings per share 43.4p 12 13 86.5p 14 20
Q2 2024 Year to date
£m AER CER £m AER CER
Cost of sales Total 2,122 10% 13% 4,092 6% 7%
% of sales 26.9% <(0.1%) <0.1% 26.8% (0.6%) (1.0%)
Core 1,877 9% 12% 3,610 4% 6%
% of sales 23.8% (0.3%) (0.2%) 23.7% (1.0%) (1.3%)
Total and Core cost of sales as a percentage of sales was slightly down in the
quarter and decreased in the year to date. The quarter benefitted from growth
in higher margin Specialty Medicines products and regional mix as well as
price benefits from channel mix and adjustments to returns and rebates in the
US. In addition, in the year to date there are further mix benefits from the
growth in higher margin Arexvy.
Q2 2024 Year to date
£m AER CER £m AER CER
Selling, general & administration Total 2,465 9% 13% 4,552 3% 7%
% of sales 31.3% (0.3%) 0.1% 29.9% (1.4%) (1.4%)
Core 2,223 1% 6% 4,202 (1%) 2%
% of sales 28.2% (2.3%) (1.9%) 27.6% (2.6%) (2.6%)
In the quarter and year to date, Core SG&A improved as a percentage of
sales due to continued disciplined investment to support global market
expansion and disease awareness particularly for Arexvy and investment behind
long-acting HIV medicines. The year to date growth was partly offset by a 2
percentage point favourable impact of the reversal of the legal provision
taken in Q1 2023 for the Zejula royalty dispute, following a successful
appeal.
Total SG&A growth also included an increase in Significant legal costs
reflecting prospective legal fees for the defence of the litigation relating
to Zantac (see details on page 38).
Q2 2024 Year to date
£m AER CER £m AER CER
Research & Total 1,477 10% 12% 2,911 12% 14%
development
% of sales 18.7% 0.1% (0.1%) 19.1% 0.7% 0.4%
Core 1,415 8% 9% 2,774 9% 12%
% of sales 17.9% (0.4%) (0.6%) 18.2% 0.2% <(0.1%)
In Q2 2024 and year to date, R&D expense increased due to continued
investment across disease areas, including bepirovirsen (chronic hepatitis B)
and the advancement of clinical trial programmes associated with the
pneumococcal Multi Antigen Presenting System (MAPS) and mRNA in Infectious
Diseases.
In HIV, investment increased on next-generation long-acting treatment and
preventative medicines. In Respiratory and Oncology, investment increased to
support lifecycle innovation and late-stage clinical development programmes
for depemokimab (asthma and eosinophilic inflammation), camlipixant
(refractory chronic cough), and Jemperli (endometrial cancer). This was partly
offset by cost decreases following launches of Arexvy and Ojjaara and
reduction in development spend for Zejula.
Q2 2024 Year to date
£m AER CER £m AER CER
Royalty income Total 144 (36%) (37%) 295 (27%) (27%)
Core 144 (36%) (37%) 295 (27%) (27%)
The decrease in Total and Core royalty income in Q2 2024 and year to date
primarily reflected the cessation of the majority of Gardasil royalties at the
end of 2023, with Q2 2024 Gardasil royalties of £12 million (Q2 2023: £132
million). This was partly offset by increases in Kesimpta and Biktarvy
royalties.
Q2 2024 Year to date
£m AER CER £m AER CER
Other operating Total (318) >(100%) >(100%) (851) >(100%) >(100%)
income/(expense)
In Q2 2024 the other operating expense reflected a charge of £378 million (Q2
2023: £189 million credit) arising from the remeasurement of contingent
consideration liabilities (CCL) primarily reflecting improved longer term HIV
prospects and foreign currency movements, an increase in liability for the
Vaccines CCL, and the liabilities for the Pfizer, Inc. (Pfizer) put option. In
addition, there was a fair value loss of £35 million (Q2 2023: £35 million
gain) on the retained stake in Haleon plc (Haleon), partly offset by higher
other net income of £95 million (Q2 2023: £54 million). All of the remaining
shares held in Haleon were sold in May 2024.
The year to date other operating expense reflected a charge of £1,063 million
(YTD 2023: £460 million credit) arising from the remeasurement of CCLs
primarily reflecting improved longer term HIV prospects and foreign currency
movements and increase in liability for the Vaccines CCL and the liabilities
for the Pfizer put option. This was partly offset by a fair value gain of £22
million (YTD 2023: £29 million loss) on the retained stake in Haleon, as well
as higher other net income of £190 million (YTD 2023: £144 million).
Q2 2024 Year to date
£m AER CER £m AER CER
Operating profit Total 1,646 (23%) (22%) 3,136 (26%) (20%)
% of sales 20.9% (8.9%) (9.1%) 20.6% (9.3%) (8.4%)
Core 2,513 16% 18% 4,956 16% 22%
% of sales 31.9% 1.6% 1.3% 32.5% 2.3% 2.9%
Total operating profit margin was lower in Q2 2024 primarily due to
unfavourable movements in the ViiV Healthcare CCL reflecting improved longer
term HIV prospects and foreign currency movements, an increase in liability
for the Vaccines CCL and a fair value loss on the retained stake in Haleon (Q2
2023 fair value gain), partly offset by higher other net income. The year to
date also has unfavourable movements in CCL remeasurements, partly offset by a
fair value gain on the retained Haleon shares (2023 year to date fair value
loss) and higher other net income.
Core operating profit in the quarter and year to date benefitted from
continued leverage from strong sales and favourable product and regional mix.
This was partly offset by increased investment in R&D and growth assets,
and lower royalty income. The year to date also includes a favourable impact
from the reversal of the legal provision taken in Q1 2023 for the Zejula
royalty dispute, following a successful appeal. The adverse impact of lower
sales of COVID-19 solutions was three percentage points of Core operating
profit growth in the quarter and six percentage points year to date, with
minimal impact on Core operating profit margin.
Q2 2024 Year to date
£m AER CER £m AER CER
Net finance expense Total 150 (1%) 1% 284 (13%) (12%)
Core 148 (3%) (1%) 280 (13%) (12%)
The decrease in net finance costs in Q2 2024 and year to date was mainly
driven by lower interest on short-term financing as a result of cash received
from the successful disposal of all Haleon shares and savings from maturing
bonds, partly offset by higher lease interest expense. Year to date also
benefitted from the net cost of bond buybacks completed in Q1 2023.
Q2 2024 Year to date
£m AER CER £m AER CER
Taxation Total 191 (21%) (19%) 465 (10%) (2%)
Tax rate % 12.8% 16.3%
Core 423 34% 36% 827 34% 41%
Tax rate % 17.9% 17.7%
The effective tax rate on Total results reflects 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 and includes the impact of new global minimum corporate income
tax rules which came into effect from 1 January 2024 in line with the OECD's
'Pillar 2' model framework. Issues related to taxation are described in Note
14, 'Taxation' in the Annual Report 2023. 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.
Q2 2024 Year to date
£m AER CER £m AER CER
Non-controlling Total 131 8% 14% 166 (37%) (29%)
interests ("NCIs")
Core 170 31% 37% 324 29% 37%
The increase in Total profit allocated to NCIs in the quarter was primarily
driven by higher net profits in some of the Group's other entities. The
decrease in the year to date Total profit allocated to NCIs was driven by
lower ViiV Healthcare Total profits (including the remeasurement loss on the
CCL) with an allocation of £150 million (YTD 2023: £267 million), partly
offset by higher net profits in some of the Group's other entities.
The increase in Core profit from operations allocated to NCIs in Q2 2024 and
year to date primarily reflected higher core profit allocations from ViiV
Healthcare, with £161 million in the quarter (Q2 2023: £136 million) and
£308 million in the year to date (YTD 2023: £256 million), as well as higher
net profits in some of the Group's other entities with NCIs.
Q2 2024 Year to date
£p AER CER £p AER CER
Earnings per share Total 28.8p (28%) (27%) 54.5p (29%) (24%)
Core 43.4p 12% 13% 86.5p 14% 20%
The decrease in the Q2 2024 and year to date Total EPS is primarily due to
higher charges for CCL remeasurements reflecting improved longer term HIV
prospects and foreign currency movements.
The increase in the Core EPS in the quarter and year to date primarily
reflected the growth in Core operating profit as well as lower finance costs,
partly offset by higher non-controlling interests and a higher effective
taxation rate. Lower sales of COVID-19 solutions reduced Core EPS by four
percentage points in the quarter and by six percentage points in the year to
date.
Currency impact on results
The results for Q2 2024 are based on average exchange rates, principally
$1.26/£1, €1.17/£1 and Yen198/£1. The period-end exchange rates were
$1.27/£1, €1.18/£1 and Yen 203/£1. Comparative exchange rates are given
on page 41.
Q2 2024 Year to date
£m/£p AER CER £m/£p AER CER
Turnover 7,884 10% 13% 15,247 8% 12%
Earnings per share Total 28.8p (28%) (27%) 54.5p (29%) (24%)
Core 43.4p 12% 13% 86.5p 14% 20%
In Q2 2024, the adverse currency impact primarily reflected the strengthening
of Sterling against the US Dollar, Euro and Yen. Exchange gains or losses on
the settlement of intercompany transactions had a favourable two percentage
point impact on Total and Core EPS.
In the year to date, the adverse currency impact primarily reflected the
strengthening of Sterling against the US Dollar, Euro, Yen and emerging market
currencies. Exchange gains or losses on the settlement of intercompany
transactions had a marginal impact on Total and Core EPS.
Cash generation
Cash flow
Q2 2024 Q2 2023 H1 2024 H1 2023
£m £m £m £m
Cash generated from operations (£m) 1,650 1,620 2,776 1,907
Net cash generated from operating activities (£m) 1,113 1,307 2,071 1,360
Free cash inflow/(outflow)* (£m) 328 348 617 (341)
Free cash flow growth (%) (6)% 34% >100% <(100)%
Free cash flow conversion* (%) 28% 21% 28% -
Total net debt** (£m) 13,960 18,220 13,960 18,220
* Free cash flow and free cash flow conversion are defined on page 60. Free
cash flow is analysed on page 44.
** Net debt is analysed on page 44.
Q2 2024
Cash generated from operations for the quarter was £1,650 million (Q2 2023:
£1,620 million). The increase primarily reflected higher Core operating
profit and lower additional pension contributions, partly offset by an
increase in trade receivables due to higher sales and the timing of returns
and rebates, including the impact of the removal of the AMP cap.
Total contingent consideration cash payments in the quarter were £317 million
(Q2 2023: £288 million), including cash payments made to Shionogi & Co.
Ltd (Shionogi) of £305 million (Q2 2023: £278 million). £313 million (Q2
2023: £285 million) of these were recognised in cash flows from operating
activities.
Free cash inflow was £328 million for the quarter (Q2 2023: £348 million).
In addition to the increase in cash generated from operations, there was lower
net interest paid, lower dividends paid to non-controlling interests and lower
capital expenditure. These were more than offset by higher tax payments,
resulting in a decrease in free cash flow in the quarter.
H1 2024
Cash generated from operating activities was £2,776 million (H1 2023: £1,907
million). The increase primarily reflected higher Core operating profit,
higher receivables' collections, particularly for Arexvy and Shingrix, and
lower pension contributions. This was partly offset by the timing of returns
and rebates, including the impact of the removal of the AMP cap.
Total contingent consideration cash payments in H1 2024 were £626 million
(H1 2023: £579 million), including cash payments made to Shionogi of
£605 million (H1 2023: £565 million). £619 million (H1 2023:
£575 million) of these were recognised in cash flows from operating
activities.
Free cash inflow was £617 million for H1 2024 (H1 2023: £341 million
outflow). The increase was primarily driven by the increase in cash generated
from operating activities, as well as lower net interest paid, lower dividends
paid to non-controlling interests and lower capital expenditure, partly offset
by higher tax payments.
Total Net debt
At 30 June 2024, net debt was £13,960 million, compared with £15,040 million
at 31 December 2023, comprising gross debt of £16,943 million and cash and
liquid investments of £2,983 million. See net debt information on page 43 and
44.
Net debt decreased by £1,080 million primarily due to £617 million free cash
inflow and £2,296 million proceeds from the disposal of investments,
primarily the sale of the remaining retained stake in Haleon, and exchange on
net debt of £97 million. This was partly offset by the net acquisition costs
of Aiolos Bio, Inc. (Aiolos) and Elsie Biotechnologies for £748 million, and
dividends paid to shareholders of £1,220 million.
At 30 June 2024, GSK had short-term borrowings (including overdrafts and lease
liabilities) repayable within 12 months of £3,366 million and £845 million
repayable in the subsequent year.
Page
Q2 2024 pipeline highlights 14
ESG 16
Total and Core results 18
Income statement 26
Statement of comprehensive income 27
Balance sheet 28
Statement of changes in equity 29
Cash flow statement 30
Sales tables 31
Segment information 36
Legal matters 38
Returns to shareholders 40
Additional information 41
Net debt information 43
Post balance sheet event 44
Related party transactions 44
Financial instruments fair value disclosures 45
R&D commentary 50
Principal risks and uncertainties 59
Reporting definitions 60
Guidance and outlooks, assumptions and cautionary statements 62
Directors' responsibility statement 63
Independent Auditor's review report to GSK plc 64
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.
GSK enquiries:
Media Tim Foley +44 (0) 20 8047 5502 (London)
Kathleen Quinn +1 202 603 5003 (Washington)
Investor Relations Nick Stone +44 (0) 7717 618834 (London)
James Dodwell +44 (0) 7881 269066 (London)
Mick Readey +44 (0) 7990 339653 (London)
Joshua Williams +44 (0) 7385 415719 (London)
Jeff McLaughlin +1 215 589 3774 (Philadelphia)
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
Q2 2024 pipeline highlights (since 1 May 2024)
Medicine/vaccine Trial (indication, presentation) Event
Regulatory decisions or other regulatory actions Arexvy RSV, adults aged 50-59 years at increased risk Regulatory decision (US)
Arexvy RSV, adults aged 50-59 years at increased risk Positive CHMP opinion (EU)
Omjjara MOMENTUM (myelofibrosis with anaemia) Regulatory decision (JP)
Regulatory submissions or acceptances Jemperli RUBY part 1 (OS overall population, 1L endometrial cancer) Regulatory submission (EU)
Blenrep DREAMM-7/8 (2L+ multiple myeloma) Regulatory submission (EU)
Phase III data readouts or other significant events depemokimab SWIFT-1/2 (severe asthma) Positive phase III data readout
Anticipated news flow
Timing Medicine/vaccine Trial (indication, presentation) Event
H2 2024 Arexvy RSV, adults aged 50-59 years at increased risk Regulatory decision (EU, JP)
gepotidacin EAGLE-2/3 (uncomplicated urinary tract infection) Regulatory submission (US)
depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps) Phase III data readout
depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps) Regulatory submission (US)
depemokimab SWIFT-1/2 (severe asthma) Regulatory submission (US)
Nucala Chronic rhinosinusitis with nasal polyps Regulatory decision (JP)
Nucala MATINEE (chronic obstructive pulmonary disease) Phase III data readout
Nucala MATINEE (chronic obstructive pulmonary disease) Regulatory submission (US)
Blenrep DREAM-7/8 (2L + multiple myeloma) Regulatory submission
(US, JP)
Blenrep DREAMM-7 (2L + multiple myeloma) Regulatory submission (CN)
Jemperli RUBY part 1 (OS overall population, 1L endometrial cancer) Regulatory decision (US)
Zejula FIRST (1L maintenance ovarian cancer) Phase III data readout
Zejula ZEAL (1L maintenance non-small cell lung cancer) Phase III data readout
linerixibat GLISTEN (cholestatic pruritus in primary biliary cholangitis) Phase III data readout
Anticipated news flow continued
Timing Medicine/vaccine Trial (indication, presentation) Event
H1 2025 Arexvy RSV, adults aged 18-49 years at increased risk Phase III data readout
MenABCWY (gen 1) vaccine candidate Meningococcal ABCWY Regulatory decision (US)
Shingrix Shingles, adults aged 18+ years Regulatory decision (CN)
gepotidacin EAGLE-2/3 (uncomplicated urinary tract infection) Regulatory decision (US)
gepotidacin EAGLE-1 (urogenital gonorrhoea) Regulatory submission (US)
depemokimab SWIFT-1/2 (severe asthma) Regulatory submission
(EU, CN, JP)
depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps) Regulatory submission
(EU, CN, JP)
Nucala Chronic rhinosinusitis with nasal polyps Regulatory decision (CN)
Nucala MATINEE (chronic obstructive pulmonary disease) Regulatory decision (US)
Nucala MATINEE (chronic obstructive pulmonary disease) Regulatory submission
(CN, EU)
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 (JP)
cobolimab COSTAR (non-small cell lung cancer) Phase III data readout
Jemperli RUBY part 1 (OS overall population, 1L endometrial cancer) Regulatory decision (EU)
linerixibat GLISTEN (cholestatic pruritus in primary biliary cholangitis) Regulatory submission
(US, EU, CN)
H2 2025 Arexvy RSV, adults aged 18-49 years at increased risk Regulatory submission (US)
Bexsero Meningococcal B (infants) Phase III data read out
Bexsero Meningococcal B (infants) Regulatory submission (US)
gepotidacin EAGLE-1 (urogenital gonorrhoea) Regulatory decision (US)
gepotidacin EAGLE-J (uncomplicated urinary tract infection) Regulatory submission (JP)
tebipenem pivoxil PIVOT-PO (complicated urinary tract infection) Phase III data readout
tebipenem pivoxil PIVOT-PO (complicated urinary tract infection) Regulatory submission (US)
camlipixant CALM-1/2 (refractory chronic cough) Phase III data readout
camlipixant CALM-1/2 (refractory chronic cough) Regulatory submission
(US, EU)
depemokimab SWIFT-1/2 (severe asthma) Regulatory decision (US)
depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps) Regulatory decision (US)
depemokimab OCEAN (eosinophilic granulomatosis with polyangiitis) Phase III data readout
depemokimab NIMBLE (asthma) Phase III data readout
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)
linerixibat GLISTEN (cholestatic pruritus in primary biliary cholangitis) Regulatory decision (US)
linerixibat GLISTEN (cholestatic pruritus in primary biliary cholangitis) Regulatory submission (JP)
Refer to pages 50 to 58 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 Environmental, Social, and Governance
(ESG) 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 Q1 2024 results. For more details on annual updates, please see
GSK's ESG Performance Report 2023. (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 Q1 2024:
• In July, GSK announced that the first single-dose medicine for the prevention
of relapse of Plasmodium vivax (P. vivax) malaria - tafenoquine,
co-administered with chloroquine for radical cure, has now been launched in
both Thailand and Brazil. The development and launch of this new treatment is
the result of a partnership between GSK and Medicines for Malaria Venture.
More information can be found here. (2)
• In April, ViiV Healthcare announced that ten years after the signing of
ground-breaking licensing agreements with the Medicines Patent Pool (MPP),
more than 1 billion packs of generic dolutegravir (DTG) - based medicines have
reached 24 million people living with HIV in 128 low- and middle-income
countries (LMICs). The partnership has also accelerated access to innovative
HIV medicines for paediatrics, as well as furthering access to innovative HIV
prevention for adults, with a licence agreement supporting access to
cabotegravir long-acting in LMICs. More information can be found here. (3)
• In June, the inaugural set of funding partners of the Global Fund's Gender
Equality Fund - set up to recognise the critical importance of gender equality
to ending AIDS, tuberculosis (TB) and malaria as epidemics - were announced.
They will be awarded up to $7.5 million in grants over the next three years to
help accelerate progress towards gender equality through community engagement
and empowerment. More information can be found here. (4)
• Performance metrics related to access are updated annually with related
details in GSK's ESG Performance Report 2023 on page 10.
Global health and health security
Commitment: develop novel products and technologies to treat and prevent
priority diseases, including pandemic threats.
Progress since Q1 2024:
• In May, GSK made a £45 million pledge to support the Fleming Initiative, a
new global network of scientific, technology, clinical, policy and public
engagement expertise, to develop new antimicrobial resistance (AMR)
interventions. AMR is an urgent global public health threat, with potential to
cause 10 million deaths annually by 2050 without effective action. The
partnership will bring together GSK's leadership in prevention and treatment
of infectious diseases, along with Imperial College London and Imperial
College Healthcare NHS Trust's world-class clinical and research expertise.
More information can be found here. (5)
• Performance metrics related to global health and health security are updated
annually with related details in GSK's ESG Performance Report 2023 on page 15.
Environment
Commitment: committed to a net zero, nature-positive, healthier planet with
ambitious goals set for 2030 and 2045.
Progress since Q1 2024:
• In May, Phase III trials started for a low carbon version of our metered dose
inhaler (MDI), Ventolin (salbutamol), using a next generation propellant. The
propellants currently contained in all MDIs, including GSK's, contribute to
greenhouse gas emissions. The gas released through patient use of Ventolin MDI
specifically accounts for close to half (48%) of GSK's global total carbon
footprint. If successful, this has the potential to reduce greenhouse gas
emissions from use of the inhaler by approximately 90%, significantly
contributing to GSK's ambitious net-zero climate targets.
• GSK continues to make progress towards its reduction in greenhouse gas
emissions across all scopes by 2030 and 2045, including increasing its use of
renewable energy. In June, GSK activated a new 56-acre solar farm and two new
wind turbines at its Irvine manufacturing site and also announced it signed a
10-year energy deal with Sembcorp, covering the electricity demand for all
three of GSK's global manufacturing sites in Singapore. This means that from 1
January 2025, all of GSK's manufacturing operations in Singapore will be
covered by renewable energy certificates from Sembcorp's solar projects in
Singapore, along with the 3% already being generated by GSK's on-site solar
panels. More information can be found here. (6)
• Performance metrics related to environment are updated annually with related
details in GSK's ESG Performance Report 2023 on page 18.
Diversity, equity and inclusion
Commitment: create a diverse, equitable and inclusive workplace; enhance
recruitment of diverse patient populations in GSK clinical trials; and support
diverse communities.
• Performance metrics related to diversity, equity and inclusion are updated
annually with related details in GSK's ESG Performance Report 2023 on page 26.
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 ESG Performance Report 2023 on page 30.
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 ESG Performance Report 2023 on page 35.
ESG rating performance
Detailed below is how GSK performs in key ESG ratings.
Current Previous
External benchmark score/ranking score/ranking Comments
S&P Global's Corporate Sustainability Assessment 79 84 2nd in the pharmaceutical industry group; current score updated July 2024.
Access to Medicines Index 4.06 4.23 Led the bi-annual index since its inception in 2008; Updated bi-annually,
current results from Nov 2022
Antimicrobial resistance benchmark 84% 86% Led the benchmark since its inception in 2018; Current ranking updated Nov
2021
CDP Climate Change A- A- Updated annually, current scores updated February 2024 (for supplier
engagement, March 2023)
CDP Water Security A- B
CDP Forests (palm oil) B A-
CDP Forests (timber) B B
CDP supplier engagement rating Leader Leader
Sustainalytics 15.4 16.7 2nd percentile in pharma subindustry group; lower score represents lower risk.
Current ranking updated May 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 June 2023
FTSE4Good Member Member Member since 2004, latest review in June 2024
ShareAction's Workforce Disclosure Initiative 79% 77% Current score updated Jan 2024
Footnotes:
(1) https://www.gsk.com/media/11009/esg-performance-report-2023.pdf
(2) https://www.gsk.com/en-gb/media/press-releases/brazil-and-thailand-become-first-malaria-endemic-countries-to-launch-new-single-dose-radical-cure-medicine/
(3) https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/april/mpp-10-years-anniversary/
(4) https://www.theglobalfund.org/en/news/2024/2024-06-13-gender-equality-fund-announces-funding-partners/
(5) https://www.gsk.com/en-gb/media/press-releases/gsk-to-become-a-founding-partner-of-fleming-initiative-to-fight-antimicrobial-resistance-amr/
(6) https://www.gsk.com/media/11369/gsk-set-to-achieve-100-renewable-electricity-at-all-manufacturing-sites-in-singapore-from-2025.pdf
Total and Core results
Total reported results represent the Group's overall performance.
GSK made one update to its reporting framework in Q1 2024 which is to change
the description of Adjusted results to Core to align with European peers in
the pharmaceutical industry but with no change to the basis or figures. In Q2
2024 an update was made to the definition of Core results to exclude amounts
greater than £25 million from the foreign currency translation reserve which
are reclassified to the income statement upon the liquidation of a subsidiary.
There is no impact in the quarter or year to date from this adjusting item.
There is no change to Total Results.
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 page 60.
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 20 and 23.
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 84% of the Total earnings and 83% of the Core earnings of ViiV
Healthcare for 2023.
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 six
months ended 30 June 2024 were £605 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 84 and 85 of the Annual Report 2023.
Adjusting items
The reconciliations between Total results and Core results for Q2 2024 and Q2
2023 are set out below.
Three months ended 30 June 2024
Total Intangible Intangible Major Trans- Divest- Core
results amort- impair- restruct- action- ments, results
£m isation ment uring related Significant £m
£m £m £m £m legal and
other
items
£m
Turnover 7,884 7,884
Cost of sales (2,122) 180 41 19 5 (1,877)
Gross profit 5,762 180 41 19 5 6,007
Selling, general and administration (2,465) 75 1 166 (2,223)
Research and development (1,477) 13 47 2 (1,415)
Royalty income 144 144
Other operating income/(expense) (318) 6 378 (66) -
Operating profit 1,646 193 47 124 398 105 2,513
Net finance expense (150) 2 (148)
Share of after tax profit/(loss) of associates (1) (1)
and joint ventures
Profit before taxation 1,495 193 47 124 398 107 2,364
Taxation (191) (43) (11) (34) (121) (23) (423)
Tax rate % 12.8% 17.9%
Profit after taxation 1,304 150 36 90 277 84 1,941
Profit attributable to non-controlling 131 39 170
interests
Profit attributable to shareholders 1,173 150 36 90 238 84 1,771
1,304 150 36 90 277 84 1,941
Earnings per share 28.8p 3.7p 0.9p 2.2p 5.8p 2.0p 43.4p
Weighted average number of shares (millions) 4,079 4,079
Three months ended 30 June 2023
Total Intangible Intangible Major Trans- Divest- Core
results amort- impair- restruct- action- ments, results
£m isation ment uring related Significant £m
£m £m £m £m legal and
other
items
£m
Turnover 7,178 7,178
Cost of sales (1,932) 164 33 7 (1,728)
Gross profit 5,246 164 33 7 5,450
Selling, general and administration (2,268) 11 66 (2,191)
Research and development (1,341) 20 4 2 (1,315)
Royalty income 226 226
Other operating income/(expense) 278 (189) (89) -
Operating profit 2,141 184 4 46 (189) (16) 2,170
Net finance expense (152) 1 (1) (152)
Share of after tax profit/(loss) of associates (2) (2)
and joint ventures
Profit before taxation 1,987 184 4 47 (189) (17) 2,016
Taxation (242) (40) (1) (11) 17 (38) (315)
Tax rate % 12.2% 15.6%
Profit after taxation 1,745 144 3 36 (172) (55) 1,701
Profit attributable to non-controlling 121 9 130
interests
Profit attributable to shareholders 1,624 144 3 36 (181) (55) 1,571
1,745 144 3 36 (172) (55) 1,701
Earnings per share 40.1p 3.5p 0.1p 0.9p (4.5)p (1.3)p 38.8p
Weighted average number of shares (millions) 4,053 4,053
Adjusting items Q2 2024
Major restructuring and integration
Total Major restructuring charges incurred in Q2 2024 were £124 million (Q2
2023: £46 million), analysed as follows:
Q2 2024 Q2 2023
Cash Non- Total Cash Non- Total
£m cash £m £m cash £m
£m £m
Separation Preparation restructuring 99 8 107 25 4 29
programme
Significant acquisitions 16 1 17 15 1 16
Legacy programmes - - - 2 (1) 1
115 9 124 42 4 46
The Separation Preparation programme incurred cash charges of £99 million
primarily from restructuring of some commercial and administrative functions
as well as Global Supply Chain. The non-cash charges of £8 million primarily
reflected the write down of assets in manufacturing locations.
Costs of significant acquisitions relate to integration costs of Sierra
Oncology Inc. (Sierra) and Affinivax Inc. (Affinivax) which were acquired in
Q3 2022, BELLUS Health Inc. (Bellus) acquired in Q2 2023 and Aiolos acquired
in Q1 2024.
Transaction-related adjustments
Transaction-related adjustments resulted in a net charge of £398 million (Q2
2023: £189 million credit), 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) Q2 2024 Q2 2023
£m £m
Contingent consideration on former Shionogi-ViiV Healthcare joint Venture 228 (9)
(including Shionogi preferential dividends)
ViiV Healthcare put options and Pfizer preferential dividends 4 (138)
Contingent consideration on former Novartis Vaccines business 132 (53)
Contingent consideration on acquisition of Affinivax 11 11
Other adjustments 23 -
Total transaction-related charges 398 (189)
The £228 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 by £124 million
from updated sales forecasts and exchange rates, and the unwind of the
discount for £104 million. The £4 million charge relating to the ViiV
Healthcare put option and Pfizer preferential dividends represented an
increase in the valuation of the put option primarily as a result of updated
sales forecasts.
The ViiV Healthcare contingent consideration liability is fair valued under
IFRS. An explanation of the accounting for the non-controlling interests in
ViiV Healthcare is set out on page 19.
The £132 million charge relating to the contingent consideration on the
former Novartis Vaccines business primarily relates to changes to future sales
forecasts.
The £11 million charge relating to the contingent consideration on the
acquisition of Affinivax primarily relates to the unwind of the discount.
Divestments, Significant legal charges, and other items
Divestments, Significant legal charges, and other items included other net
income of £66 million, which includes milestone income and a £16 million
final dividend from Haleon as well as a fair value loss of £35 million on the
investment in Haleon, which was sold in May 2024. Legal charges provide for
all significant legal matters and are not broken out separately by litigation
or investigation. Significant legal charges in the quarter primarily reflected
prospective legal fees for the defence of the litigation relating to Zantac.
The reconciliations between Total results and Core results for H1 2024 and H1
2023 are set out below.
Six months ended 30 June 2024
Total Intangible Intangible Major Trans- Divest- Core
results amort- impair- restruct- action- ments, results
£m isation ment uring related Significant £m
£m £m £m £m legal and
other
items
£m
Turnover 15,247 15,247
Cost of sales (4,092) 362 74 38 8 (3,610)
Gross profit 11,155 362 74 38 8 11,637
Selling, general and administration (4,552) 92 1 257 (4,202)
Research and development (2,911) 27 101 9 (2,774)
Royalty income 295 295
Other operating income/(expense) (851) 6 1,063 (218) -
Operating profit 3,136 389 101 181 1,102 47 4,956
Net finance expense (284) 4 (280)
Share of after tax profit/(loss) of associates (2) (2)
and joint venture
Profit before taxation 2,850 389 101 181 1,102 51 4,674
Taxation (465) (84) (25) (47) (197) (9) (827)
Tax rate % 16.3% 17.7%
Profit after taxation 2,385 305 76 134 905 42 3,847
Profit attributable to non-controlling 166 158 324
interests
Profit attributable to shareholders 2,219 305 76 134 747 42 3,523
2,385 305 76 134 905 42 3,847
Earnings per share 54.5p 7.5p 1.9p 3.3p 18.3p 1.0p 86.5p
Weighted average number of shares (millions) 4,074 4,074
Six months ended 30 June 2023
Total Intangible Intangible Major Trans- Divest- Core
results amort- impair- restruct- action- ments, results
£m isation ment uring related Significant £m
£m £m £m £m legal and
other
items
£m
Turnover 14,129 14,129
Cost of sales (3,875) 315 68 12 (3,480)
Gross profit 10,254 315 68 12 10,649
Selling, general and administration (4,411) 80 75 (4,256)
Research and development (2,601) 38 20 6 (2,537)
Royalty income 406 406
Other operating income/(expense) 575 (460) (115) -
Operating profit 4,223 353 20 154 (460) (28) 4,262
Net finance expense (326) 1 3 (322)
Share of after tax profit/(loss) of (4) (4)
associates and joint ventures
Profit/(loss) on disposal of interest in 1 (1) -
associates
Profit before taxation 3,894 353 20 155 (460) (26) 3,936
Taxation (518) (76) (5) (33) 32 (18) (618)
Tax rate % 13.3% 15.7%
Profit after taxation 3,376 277 15 122 (428) (44) 3,318
Profit attributable to non-controlling 262 (11) 251
interests
Profit attributable to shareholders 3,114 277 15 122 (417) (44) 3,067
3,376 277 15 122 (428) (44) 3,318
Earnings per share 76.9p 6.8p 0.4p 3.0p (10.3)p (1.0)p 75.8p
Weighted average number of shares (millions) 4,048 4,048
Adjusting items H1 2024
Major restructuring and integration
Total Major restructuring charges incurred in H1 2024 were £181 million (H1
2023: £154 million), analysed as follows:
H1 2024 H1 2023
Cash Non- Total Cash Non- Total
£m cash £m £m cash £m
£m £m
Separation Preparation restructuring programme 127 16 143 62 51 113
Significant acquisitions 35 1 36 36 2 38
Legacy programmes 2 - 2 2 1 3
164 17 181 100 54 154
The Separation Preparation programme incurred cash charges of £127 million
primarily from the restructuring of some commercial and administrative
functions as well as Global Supply Chain. The non-cash charges of £16 million
primarily reflected the write-down of assets in manufacturing locations.
The programme is now largely complete and has delivered its target of £1.1
billion of annual savings, with total costs still expected at £2.4 billion,
with slightly higher cash charges of £1.7 billion but lower non-cash charges
of £0.7 billion.
Costs of significant acquisitions relate to integration costs of Sierra
Oncology Inc (Sierra) and Affinivax Inc. (Affinivax) which were acquired in Q3
2022, Bellus Health Inc. (Bellus) acquired in Q2 2023 and Aiolos acquired in
Q1 2024.
Transaction-related adjustments
Transaction-related adjustments resulted in a net charge of £1,102 million
(H1 2023: £460 million net credit), 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) H1 2024 H1 2023
£m £m
Contingent consideration on former Shionogi-ViiV Healthcare joint Venture 814 (73)
(including Shionogi preferential dividends)
ViiV Healthcare put options and Pfizer preferential dividends 70 (243)
Contingent consideration on former Novartis Vaccines business 160 (122)
Contingent consideration on acquisition of Affinivax 16 (22)
Other adjustments 42 -
Total transaction-related charges 1,102 (460)
The £814 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 £603
million from updated future sales forecasts and exchange rates, and the unwind
of the discount for £211 million. The £70 million charge relating to the
ViiV Healthcare put option and Pfizer preferential dividends represented an
increase in the valuation of the put option primarily as a result of updated
sales forecasts.
The ViiV Healthcare contingent consideration liability is fair valued under
IFRS. An explanation of the accounting for the non-controlling interests in
ViiV Healthcare is set out on page 19.
The £160 million charge relating to the contingent consideration on the
former Novartis Vaccines business primarily relates to changes to future sales
forecasts.
The £16 million charge relating to the contingent consideration on the
acquisition of Affinivax primarily relates to the unwind of the discount.
Divestments, Significant legal charges, and other items
Divestments, Significant legal charges, and other items primarily included
£218 million of other net income from milestones and dividends related to
investments, including a £16 million final dividend received from the
investment in Haleon, as well as a fair value gain of £22 million on the
investment in Haleon, which was sold in May 2024. Legal charges provide for
all significant legal matters, including Zantac, and are not broken out
separately by litigation or investigation. Significant legal charges in the
year primarily reflected increased legal charges for Zantac of which the vast
majority relate to the prospective legal fees for the defence of the
litigation.
Financial information
Income statement
Q2 2024 Q2 2023 H1 2024 H1 2023
£m £m £m £m
TURNOVER 7,884 7,178 15,247 14,129
Cost of sales (2,122) (1,932) (4,092) (3,875)
Gross profit 5,762 5,246 11,155 10,254
Selling, general and administration (2,465) (2,268) (4,552) (4,411)
Research and development (1,477) (1,341) (2,911) (2,601)
Royalty income 144 226 295 406
Other operating income/(expense) (318) 278 (851) 575
OPERATING PROFIT 1,646 2,141 3,136 4,223
Finance income 24 33 56 62
Finance expense (174) (185) (340) (388)
Share of after tax profit/(loss) of associates and joint ventures (1) (2) (2) (4)
Profit/(loss) on disposal of interests in associates and joint - - - 1
ventures
PROFIT BEFORE TAXATION 1,495 1,987 2,850 3,894
Taxation (191) (242) (465) (518)
Tax rate % 12.8% 12.2% 16.3% 13.3%
PROFIT AFTER TAXATION 1,304 1,745 2,385 3,376
Profit attributable to non-controlling interests 131 121 166 262
Profit attributable to shareholders 1,173 1,624 2,219 3,114
1,304 1,745 2,385 3,376
EARNINGS PER SHARE 28.8p 40.1p 54.5p 76.9p
Diluted earnings per share 28.5p 39.7p 53.9p 76.2p
Statement of comprehensive income
Q2 2024 Q2 2023 H1 2024 H1 2023
£m £m £m £m
Total profit for the period 1,304 1,745 2,385 3,376
Items that may be reclassified subsequently to income statement:
Exchange movements on overseas net assets and net (21) (80) (211) 7
investment hedges
Reclassification of exchange movements on liquidation or 1 (10) 1 (13)
disposal of overseas subsidiaries and associates
Fair value movements on cash flow hedges - 1 - 1
Deferred tax on fair value movements on cash flow hedges - (1) - (1)
Reclassification of cash flow hedges to income statement - 2 2 3
(20) (88) (208) (3)
Items that will not be reclassified to income statement:
Exchange movements on overseas net assets of 4 (8) 7 (22)
non-controlling interests
Fair value movements on equity investments (159) 51 (81) (117)
Tax on fair value movements on equity investments 18 (5) 3 17
Fair value movements on cash flow hedges (2) (34) (1) (34)
Remeasurement gains/(losses) on defined benefit plans 135 (300) 181 50
Tax on remeasurement losses/(gains) on defined benefit (32) 79 (42) (8)
plans
(36) (217) 67 (114)
Other comprehensive income/(expense) for the period (56) (305) (141) (117)
Total comprehensive income for the period 1,248 1,440 2,244 3,259
Total comprehensive income for the period attributable to:
Shareholders 1,113 1,327 2,071 3,019
Non-controlling interests 135 113 173 240
1,248 1,440 2,244 3,259
Balance sheet
30 June 2024 31 December 2023
£m £m
ASSETS
Non-current assets
Property, plant and equipment 8,982 9,020
Right of use assets 841 937
Goodwill 6,960 6,811
Other intangible assets 15,473 14,768
Investments in associates and joint ventures 53 55
Other investments 1,099 1,137
Deferred tax assets 6,166 6,049
Other non-current assets 1,728 1,584
Total non-current assets 41,302 40,361
Current assets
Inventories 5,859 5,498
Current tax recoverable 519 373
Trade and other receivables 7,259 7,385
Derivative financial instruments 84 130
Current equity investments - 2,204
Liquid investments 21 42
Cash and cash equivalents 2,962 2,936
Assets held for sale 60 76
Total current assets 16,764 18,644
TOTAL ASSETS 58,066 59,005
LIABILITIES
Current liabilities
Short-term borrowings (3,366) (2,813)
Contingent consideration liabilities (1,095) (1,053)
Trade and other payables (14,245) (15,844)
Derivative financial instruments (103) (114)
Current tax payable (731) (500)
Short-term provisions (805) (744)
Total current liabilities (20,345) (21,068)
Non-current liabilities
Long-term borrowings (13,577) (15,205)
Corporation tax payable (104) (75)
Deferred tax liabilities (290) (311)
Pensions and other post-employment benefits (2,243) (2,340)
Other provisions (567) (495)
Contingent consideration liabilities (6,043) (5,609)
Other non-current liabilities (1,127) (1,107)
Total non-current liabilities (23,951) (25,142)
TOTAL LIABILITIES (44,296) (46,210)
NET ASSETS 13,770 12,795
EQUITY
Share capital 1,348 1,348
Share premium account 3,472 3,451
Retained earnings 8,583 7,239
Other reserves 969 1,309
Shareholders' equity 14,372 13,347
Non-controlling interests (602) (552)
TOTAL EQUITY 13,770 12,795
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 2024 1,348 3,451 7,239 1,309 13,347 (552) 12,795
Profit for the period 2,219 2,219 166 2,385
Other comprehensive (69) (79) (148) 7 (141)
income/(expense) for the period
Total comprehensive income/(expense) 2,150 (79) 2,071 173 2,244
for the period
Distributions to non-controlling interests (219) (219)
Dividends to shareholders (1,220) (1,220) (1,220)
Realised after tax losses on disposal (46) 46 -
or liquidation of equity investments
Share of associates and joint ventures 52 (52) -
realised profit/(loss) on disposal of
equity investments
Shares issued 19 19 19
Write-down on shares held by ESOP Trusts (204) 204 -
Shares acquired by ESOP Trusts 2 457 (459) -
Share-based incentive plans 155 155 155
Contributions from non-controlling interests 1 1
Changes to non-controlling interests - (5) (5)
At 30 June 2024 1,348 3,472 8,583 969 14,372 (602) 13,770
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 2023 1,347 3,440 4,363 1,448 10,598 (502) 10,096
Profit for the period 3,114 - 3,114 262 3,376
Other comprehensive 15 (110) (95) (22) (117)
income/(expense) for the period
Total comprehensive income/(expense) 3,129 (110) 3,019 240 3,259
for the period
Distributions to non-controlling interests (277) (277)
Contributions from non-controlling 7 7
interests
Dividends to shareholders (1,112) (1,112) (1,112)
Realised after tax losses on disposal or (9) 9 -
liquidation of equity investments
Share of associates and joint ventures 2 (2) -
realised profits on disposal of equity
investments
Share issued 1 8 9 9
Write-down of shares held by ESOP Trusts (101) 101 -
Shares acquired by ESOP Trusts 2 1 (3) -
Share-based incentive plans 145 145 145
Hedging gain/(loss) after taxation 32 32 32
transferred to non-financial assets
At 30 June 2023 1,348 3,450 6,418 1,475 12,691 (532) 12,159
Cash flow statement six months ended 30 June 2024
H1 2024 H1 2023
£m £m
Profit after tax 2,385 3,376
Tax on profits 465 518
Share of after tax loss/(profit) of associates and joint ventures 2 4
(Profit)/loss on disposal of interest in associates and joint ventures - (1)
Net finance expense 284 326
Depreciation, amortisation and other adjusting items 1,188 1,092
(Increase)/decrease in working capital (955) (1,237)
Contingent consideration paid (619) (575)
Increase/(decrease) in other net liabilities (excluding contingent 26 (1,596)
consideration paid)
Cash generated from operations 2,776 1,907
Taxation paid (705) (547)
Total net cash inflow/(outflow) from operating activities 2,071 1,360
Cash flow from investing activities
Purchase of property, plant and equipment (550) (529)
Proceeds from sale of property, plant and equipment 3 10
Purchase of intangible assets (455) (535)
Proceeds from sale of intangible assets 28 12
Purchase of equity investments (47) (59)
Proceeds from sale of equity investments 2,296 809
Purchase of businesses, net of cash acquired (748) (1,399)
Investment in joint ventures and associates (3) -
Contingent consideration paid (7) (4)
Disposal of businesses (10) 58
Interest received 61 62
(Increase)/decrease in liquid investments 22 -
Dividends from joint ventures and associates 15 1
Dividend and distributions from investments 16 201
Proceeds from disposal of associates and Joint ventures - 1
Total net cash inflow/(outflow) from investing activities 621 (1,372)
Cash flow from financing activities
Issue of share capital 19 9
Repayment of long-term loans - (150)
Repayment of short-term loans (788) (653)
Net increase/(repayment) of other short-term loans (74) 2,247
Repayment of lease liabilities (114) (94)
Interest paid (342) (448)
Dividends paid to shareholders (1,220) (1,112)
Distribution to non-controlling interests (207) (277)
Contributions from non-controlling interests 1 7
Other financing items 81 184
Total net cash inflow/(outflow) from financing activities (2,644) (287)
Increase/(decrease) in cash and bank overdrafts in the period 48 (299)
Cash and bank overdrafts at beginning of the period 2,858 3,425
Exchange adjustments (27) (88)
Increase/(decrease) in cash and bank overdrafts 48 (299)
Cash and bank overdrafts at end of the period 2,879 3,038
Cash and bank overdrafts at end of the period comprise:
Cash and cash equivalents 2,962 3,140
Overdrafts (83) (102)
2,879 3,038
Sales tables
Vaccines turnover - three months ended 30 June 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Shingles 832 (5) (4) 301 (36) (36) 244 - 2 287 75 80
Shingrix 832 (5) (4) 301 (36) (36) 244 - 2 287 75 80
Meningitis 323 21 24 143 19 21 116 10 12 64 56 63
Bexsero 232 20 23 85 23 26 113 11 13 34 48 57
Menveo 84 27 30 58 14 14 2 - - 24 85 100
Other 7 17 - - - - 1 - - 6 20 -
RSV 62 - - 56 - - - - - 6 - -
Arexvy 62 - - 56 - - - - - 6 - -
Influenza 7 (70) (65) (1) >(100) >(100) (1) >(100) >(100) 9 (61) (61)
Fluarix, FluLaval 7 (70) (65) (1) >(100) >(100) (1) >(100) >(100) 9 (61) (61)
Established Vaccines 775 (5) (2) 266 (14) (13) 178 (6) (4) 331 5 10
Infanrix, Pediarix 94 11 14 24 (29) (32) 29 45 50 41 32 42
Boostrix 183 12 13 111 10 11 36 12 16 36 16 19
Hepatitis 163 3 4 92 11 13 46 - - 25 (14) (14)
Rotarix 124 (33) (30) 28 (64) (64) 30 7 7 66 (15) (9)
Synflorix 62 (18) (16) - - - 1 (91) (91) 61 (6) (3)
Priorix, Priorix Tetra, 79 46 50 8 60 80 32 7 7 39 >100 >100
Varilrix
Cervarix 16 (69) (69) - - - 3 (84) (84) 13 (61) (61)
Other 54 38 44 3 (63) (63) 1 (67) (33) 50 79 82
Vaccines excluding 1,999 1 3 765 (15) (14) 537 - 2 697 29 33
COVID-19 solutions
Pandemic vaccines - (100) (100) - - - - (100) (100) - (100) (100)
Pandemic adjuvant - (100) (100) - - - - (100) (100) - (100) (100)
Vaccines 1,999 (1) 1 765 (15) (14) 537 (4) (2) 697 24 29
Vaccines turnover - six months ended 30 June 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Shingles 1,777 4 7 771 (21) (19) 473 4 5 533 94 >100
Shingrix 1,777 4 7 771 (21) (19) 473 4 5 533 94 >100
Meningitis 622 14 17 264 10 13 217 (1) 1 141 62 69
Bexsero 449 9 12 157 10 13 211 - 2 81 42 47
Menveo 164 31 35 107 11 14 4 (33) (33) 53 >100 >100
Other 9 - - - - - 2 - - 7 - -
RSV 244 - - 210 - - 1 - - 33 - -
Arexvy 244 - - 210 - - 1 - - 33 - -
Influenza 20 (43) (40) 1 - >100 (1) >(100) >(100) 20 (41) (41)
Fluarix, FluLaval 20 (43) (40) 1 - >100 (1) >(100) >(100) 20 (41) (41)
Established Vaccines 1,613 (1) 2 597 (10) (8) 356 (7) (5) 660 13 18
Infanrix, Pediarix 239 (9) (6) 111 (22) (20) 60 13 15 68 1 7
Boostrix 321 6 9 196 2 4 69 10 13 56 19 21
Hepatitis 338 3 5 183 1 4 97 5 7 58 5 9
Rotarix 278 (14) (10) 85 (32) (30) 59 (3) (2) 134 (1) 5
Synflorix 107 (22) (20) - - - 3 (84) (84) 104 (13) (9)
Priorix, Priorix Tetra, 157 47 51 14 >100 >100 61 (3) (2) 82 >100 >100
Varilrix
Cervarix 48 (39) (37) - - - 7 (75) (75) 41 (20) (16)
Other 125 42 45 8 (43) (50) - (100) (100) 117 65 70
Vaccines excluding 4,276 9 12 1,843 (2) - 1,046 (1) 1 1,387 42 48
COVID-19 solutions
Pandemic vaccines - (100) (100) - - - - (100) (100) - (100) (100)
Pandemic adjuvant - (100) (100) - - - - (100) (100) - (100) (100)
Vaccines 4,276 5 8 1,843 (2) - 1,046 (12) (10) 1,387 39 45
Specialty Medicines turnover - three months ended 30 June 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
HIV 1,757 11 13 1,191 13 15 382 7 8 184 11 13
Dolutegravir products 1,391 5 7 881 4 6 339 4 6 171 11 13
Tivicay 318 (6) (6) 193 (9) (7) 66 (4) (3) 59 (2) (5)
Triumeq 346 (12) (10) 241 (11) (9) 61 (18) (16) 44 (8) (4)
Juluca 176 8 10 141 12 13 32 (6) (3) 3 - 33
Dovato 551 28 30 306 29 31 180 21 23 65 51 56
Rukobia 38 41 44 36 44 48 2 >100 >100 - (100) (100)
Cabenuva 245 39 42 204 38 40 36 44 44 5 67 >100
Apretude 72 100 >100 69 92 94 - - - 3 - -
Other 11 (31) (37) 1 (50) (50) 5 (17) (17) 5 (37) (50)
Respiratory/Immunology 911 15 18 637 15 17 138 19 21 136 11 22
and Other
Nucala 482 14 17 287 12 14 112 18 20 83 14 23
Benlysta 418 17 20 350 18 20 30 20 20 38 6 14
Other 11 10 30 - (100) >(100) (4) - - 15 15 38
Oncology 356 >100 >100 251 >100 >100 86 15 17 19 >100 >100
Zejula 165 41 44 88 73 76 61 7 9 16 78 78
Blenrep (2) >(100) >(100) (2) - - - (100) (91) - - -
Jemperli 108 >100 >100 88 >100 >100 17 >100 >100 3 >100 >100
Ojjaara/Omjjara 85 - - 77 - - 8 - - - - -
Specialty Medicines 3,024 20 22 2,079 24 26 606 10 12 339 14 20
excluding COVID-19
solutions
Pandemic - (100) (100) - 100 100 - (100) (100) - - -
Xevudy - (100) (100) - 100 100 - (100) (100) - - -
Specialty Medicines 3,024 20 22 2,079 24 26 606 10 12 339 14 20
Specialty Medicines turnover - six months ended 30 June 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
HIV 3,370 11 14 2,222 13 16 746 6 8 402 8 14
Dolutegravir products 2,695 4 6 1,653 3 6 663 3 5 379 8 14
Tivicay 672 (4) (1) 379 (4) (2) 130 (4) (2) 163 (2) 4
Triumeq 656 (14) (12) 452 (13) (11) 120 (19) (18) 84 (14) (10)
Juluca 333 6 9 263 11 14 64 (7) (4) 6 (14) -
Dovato 1,034 25 29 559 23 27 349 20 22 126 56 64
Rukobia 71 37 40 67 40 44 4 33 33 - (100) >(100)
Cabenuva 458 51 55 375 49 53 71 58 60 12 71 86
Apretude 126 >100 >100 123 >100 >100 - - - 3 - -
Other 20 (35) (32) 4 (56) (44) 8 (27) (27) 8 (27) (27)
Respiratory/Immunology 1,546 11 15 1,015 7 10 270 21 23 261 18 29
and Other
Nucala 856 11 15 467 5 8 221 20 23 168 18 30
Benlysta 678 11 15 548 9 12 57 19 21 73 18 27
Other 12 9 27 - >(100) >(100) (8) - (12) 20 11 28
Oncology 629 >100 >100 437 >100 >100 161 10 12 31 72 72
Zejula 306 32 35 160 58 63 119 6 8 27 50 50
Blenrep (2) >(100) >(100) (3) (50) (50) 1 (95) (91) - - -
Jemperli 188 >100 >100 153 >100 >100 31 >100 >100 4 >100 >100
Ojjaara/Omjjara 137 - - 127 - - 10 - - - - -
Specialty Medicines 5,545 17 21 3,674 21 24 1,177 9 11 694 14 21
excluding COVID-19
solutions
Pandemic 1 (97) (97) - 100 100 - (100) (100) 1 (97) (97)
Xevudy 1 (97) (97) - 100 100 - (100) (100) 1 (97) (97)
Specialty Medicines 5,546 17 20 3,674 21 24 1,177 9 11 695 8 16
General Medicines turnover - three months ended 30 June 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Respiratory 2,065 15 18 1,229 29 32 356 1 3 480 (2) 4
Anoro Ellipta 160 14 17 81 17 19 56 17 19 23 - 9
Flixotide/Flovent 132 38 41 91 72 75 18 6 - 23 (12) (4)
Relvar/Breo Ellipta 281 (2) 1 115 (5) (2) 92 - 2 74 (1) 4
Seretide/Advair 298 (7) (5) 120 (4) (2) 55 (15) (14) 123 (7) (3)
Trelegy Ellipta 842 38 41 667 45 48 76 13 15 99 19 28
Ventolin 188 10 13 100 15 16 26 30 30 62 (3) 3
Other Respiratory 164 - 4 55 62 59 33 (21) (19) 76 (14) (6)
Other General Medicines 796 (5) (1) 74 (10) (6) 173 (6) (5) 549 (5) 2
Augmentin 142 6 10 - - - 41 2 2 101 7 14
Lamictal 109 (5) (2) 49 (13) (11) 26 (4) (4) 34 6 16
Other "Other General Medicines" 545 (8) (3) 25 (4) 4 106 (9) (8) 414 (8) (2)
General Medicines 2,861 9 12 1,303 26 29 529 (1) - 1,029 (3) 3
General Medicines turnover - six months ended 30 June 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Respiratory 3,790 6 10 2,092 17 20 717 (1) 1 981 (7) -
Anoro Ellipta 279 7 10 125 4 7 108 15 17 46 - 7
Flixotide/Flovent 271 7 10 186 17 20 36 (5) (5) 49 (12) (7)
Relvar/Breo Ellipta 551 (2) 2 214 (3) - 190 - 2 147 (3) 6
Seretide/Advair 580 (12) (9) 212 (13) (11) 116 (15) (13) 252 (10) (5)
Trelegy Ellipta 1,433 33 38 1,092 39 42 151 13 14 190 23 34
Ventolin 356 (5) (2) 186 (5) (2) 51 6 8 119 (11) (6)
Other Respiratory 320 (14) (9) 77 43 44 65 (22) (20) 178 (24) (18)
Other General Medicines 1,635 (6) (2) 127 (27) (25) 353 (4) (2) 1,155 (4) 2
Augmentin 328 5 10 - - - 95 (1) - 233 8 15
Lamictal 210 (14) (11) 86 (30) (28) 54 (2) - 70 4 12
Other "Other General Medicines" 1,097 (8) (3) 41 (21) (17) 204 (6) (4) 852 (8) (2)
General Medicines 5,425 2 6 2,219 13 16 1,070 (2) - 2,136 (6) 1
Commercial Operations turnover
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Three months ended 30 June 2024 7,884 10 13 4,147 15 17 1,672 2 3 2,065 7 13
Six months ended 30 June 2024 15,247 8 12 7,736 12 15 3,293 (2) - 4,218 8 15
Commercial Operations turnover excluding COVID-19 solutions
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Three months ended 30 June 2024 7,884 10 13 4,147 15 17 1,672 3 5 2,065 8 14
Six months ended 30 June 2024 15,246 9 13 7,736 12 15 3,293 2 4 4,217 10 16
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
Q2 2024 Q2 2023 Growth Growth
£m £m £% CER%
Commercial Operations (total turnover) 7,884 7,178 10 13
Operating profit by segment
Q2 2024 Q2 2023 Growth Growth
£m £m £% CER%
Commercial Operations 3,962 3,481 14 17
Research and Development (1,413) (1,273) 11 13
Segment profit 2,549 2,208 15 19
Corporate and other unallocated costs (36) (38)
Core operating profit 2,513 2,170 16 18
Adjusting items (867) (29)
Total operating profit 1,646 2,141 (23) (22)
Finance income 24 33
Finance costs (174) (185)
Share of after tax profit/(loss) of associates and (1) (2)
joint ventures
Profit before taxation 1,495 1,987 (25) (23)
Commercial Operations Core operating profit of £3,962 million grew in the
quarter driven by sales growth and favourable product and regional mix as
well as price benefits from channel mix and adjustments to returns and rebates
in the US, partly offset by disciplined investment in growth assets and lower
royalty income.
The R&D segment operating expenses of £1,413 million, grew in the quarter
driven by late-stage investment in Vaccines, Respiratory/Immunology and
Infectious Diseases, including pneumococcal and mRNA programmes, and
camlipixant for refractory chronic cough (RCC). This was partly offset by
decreases related to the completion of late-stage clinical development
programmes including RSV and momelotinib, and reduced investment in Zejula.
Turnover by segment
H1 2024 H1 2023 Growth Growth
£m £m £% CER%
Commercial Operations (total turnover) 15,247 14,129 8 12
Operating profit by segment
H1 2024 H1 2023 Growth Growth
£m £m £% CER%
Commercial Operations 7,817 6,856 14 19
Research and Development (2,721) (2,505) 9 11
Segment profit 5,096 4,351 17 23
Corporate and other unallocated costs (140) (89)
Core operating profit 4,956 4,262 16 22
Adjusting items (1,820) (39)
Total operating profit 3,136 4,223 (26) (20)
Finance income 56 62
Finance costs (340) (388)
Share of after tax profit/(loss) of associates (2) (4)
and joint ventures
Profit/(loss) on disposal of associates and joint ventures - 1
Profit before taxation 2,850 3,894 (27) (21)
Commercial Operations Core operating profit of £7,817 million grew in H1 2024
driven by continued leverage from strong sales and favourable product and
regional mix, and a reversal of the Zejula royalty dispute legal provision in
Q1 2024, partly offset by disciplined investment in growth assets and lower
royalty income.
The R&D segment operating expenses of £2,721 million, grew in H1 2024
driven by late-stage investment in Vaccines, Respiratory/Immunology and
Infectious Diseases, including pneumococcal and mRNA programmes, and
camlipixant for refractory chronic cough (RCC). This was partly offset by
decreases related to the completion of late-stage clinical development
programmes including RSV and momelotinib, and reduced investment in Zejula.
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 2023. At 30 June 2024,
the Group's aggregate provision for legal and other disputes (not including
tax matters described on page 10) was £454 million (31 December 2023: £267
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 Q1 2024 results:
Product Liability
Zantac
On 31 May 2024, the Delaware Superior Court issued its Daubert decision
allowing Plaintiffs to present expert evidence of general causation on all ten
cancer types to a jury. Defendants filed a request with the Superior Court to
certify an interlocutory appeal to the Delaware Supreme Court, which the
Superior Court denied on 1 July 2024. Defendants filed a direct appeal to the
Delaware Supreme Court on 28 June 2024. The Supreme Court has discretion as to
whether to accept the appeal. The Superior Court's decision relates only to
the admissibility of evidence and not to the determination of liability or to
the merits of the underlying claims.
In the Illinois state proceedings, on 23 May 2024, the jury returned a verdict
in GSK's favour in the first case to go to trial (Valadez, a case alleging
colorectal cancer). Prior to this verdict, the court rejected the Plaintiff's
ability to request punitive damages. The next case that was scheduled for
trial (Williams, a case alleging lung cancer) was dismissed before trial on
the basis that GSK was not the brand manufacturer of over-the-counter Zantac
at the time the Plaintiff allegedly used it and should not be liable for any
subsequent use of over-the-counter Zantac. Kasza (a case alleging breast
cancer) was dismissed with prejudice by the Plaintiff on 7 June 2024 following
the first day of jury selection. GSK resolved Gross (a case alleging prostate
cancer) on 28 June 2024 and Kimbrow (a case alleging prostate cancer) on 29
July 2024. GSK did not admit any liability in either settlement and both
cases will be dismissed as to GSK. The trial in Joiner (a case alleging
colorectal cancer) began on 16 July 2024 and Dixon (a case alleging prostate
cancer) is scheduled to begin trial on 5 September 2024. The Court recently
granted Plaintiffs' motion to consolidate three cases (Seilhymer, Snider and
Goode) for trial beginning on 18 November 2024. Additional cases have been set
for trial in 2025.
In the California Judicial Council Coordination Proceedings (JCCP), Plaintiffs
have filed an Amended Master Complaint alleging new theories of liability. A
Sargon hearing is scheduled in Russell (a case alleging bladder cancer) on 14
August 2024 and trial will begin on 30 September 2024. The seven other
bellwether cases have been given trial transfer dates of December 2024 with
the expectation that they will be set for trial in January 2025.
Trial dates have also been set in other state courts as follows: Florida
(Wilson, a case alleging prostate cancer, 23 September 2024, with a Daubert
hearing scheduled for 2 August 2024); Texas (Heald, a case alleging bladder
cancer, 21 October 2024); Pennsylvania (February, August, October 2025); and
Nevada (28 September 2026).
The trial date in the Mayor & City of Baltimore action, which was
scheduled for June 2025, has been moved by agreement of the parties to begin
in June 2026.
On 17 May 2024, GSK was served with a qui tam complaint filed by Valisure. The
action was originally filed in September 2019 and alleges claims under the
False Claims Act. The action remained under seal until 11 March 2024 when the
Department of Justice (DOJ) formally declined to intervene and pursue the
case. DOJ's declination did not terminate the action and Valisure is still
pursuing those claims.
The scientific consensus remains that there is no consistent or reliable
evidence that Zantac increases the risk of any cancer. GSK will continue to
vigorously defend itself against all claims and manage this litigation in the
best interests of the company and shareholders.
Given the current stage of the proceedings, GSK cannot meaningfully assess
what liability, if any, it may have, nor can it meaningfully assess the
liability of other parties under relevant indemnification provisions.
Commercial and corporate
Zejula Royalty Dispute
On 9 February 2024, the UK Court of Appeal ruled in the Group's favour,
overturning the trial court's judgement and determining that only Zejula sales
for uses falling within the licensed patents could be deemed royalty-bearing.
AstraZeneca requested permission to appeal and on 28 May 2024, the UK Supreme
Court rejected AstraZeneca's request. The appropriate quantum of royalties
following the Court of Appeal's judgement may be the subject of further
proceedings.
Returns to shareholders
Quarterly dividends
The Board has declared a second interim dividend for Q2 2024 of 15p per share
(Q2 2023: 14p 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 percent pay-out ratio through
the investment cycle. Consistent with this, GSK has declared a dividend of 15p
for Q2 2024 and expects to declare a dividend of 60p per share for full year
2024. 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 October 2024. 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 August 2024 with a payment date of 10 October
2024.
Paid/ Pence per £m
Payable share
2024
First interim 11 July 2024 15 612
Second interim 10 October 2024 15 612
2023
First interim 13 July 2023 14 567
Second interim 12 October 2023 14 568
Third interim 11 January 2024 14 568
Fourth interim 11 April 2024 16 652
58 2,355
Share capital in issue
At 30 June 2024, 4,079 million shares (Q2 2023: 4,053 million) were in free
issue (excluding Treasury shares and shares held by the ESOP Trusts). No
Treasury shares have been repurchased since 2014. The company issued 0.2
million shares under employee share schemes in the quarter for proceeds of £1
million (Q2 2023: £1 million).
At 30 June 2024, the ESOP Trusts held 66.1 million shares of GSK shares, of
which 65.8 million were held for the future exercise of share options and
share awards and 0.3 million were held for the Executive Supplemental Savings
plan. The carrying value of £546 million has been deducted from other
reserves. The market value of these shares was £1,011 million.
At 30 June 2024, the company held 169 million Treasury shares at a cost of
£2,958 million which has been deducted from retained earnings.
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
Q2 2024 Q2 2023
millions millions
Weighted average number of shares - basic 4,079 4,053
Dilutive effect of share options and share awards 43 40
Weighted average number of shares - diluted 4,122 4,093
Weighted average number of shares
H1 2024 H1 2023
millions millions
Weighted average number of shares - basic 4,074 4,048
Dilutive effect of share options and share awards 43 41
Weighted average number of shares - diluted 4,117 4,089
Additional information
Accounting policies and basis of preparation
This unaudited Results Announcement contains condensed financial information
for the three and six months ended 30 June 2024 and should be read in
conjunction with the Annual Report 2023, which was prepared in accordance with
United Kingdom adopted International Financial Reporting Standards. This
Results Announcement has been prepared applying consistent accounting policies
to those applied by the Group in the Annual Report 2023.
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 2023.
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 2023 were published in the Annual Report 2023,
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:
Q2 2024 Q2 2023 H1 2024 H1 2023 2023
Average rates:
US$/£ 1.26 1.25 1.27 1.23 1.24
Euro/£ 1.17 1.15 1.17 1.14 1.15
Yen/£ 198 173 193 168 175
Period-end rates:
US$/£ 1.27 1.26 1.27 1.26 1.27
Euro/£ 1.18 1.17 1.18 1.17 1.15
Yen/£ 203 183 203 183 180
Contingent liabilities
There were contingent liabilities at 30 June 2024 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 38 and pages
263 to 266 of the 2023 Annual Report.
Net assets
The book value of net assets increased by £975 million from £12,795 million
at 31 December 2023 to £13,770 million at 30 June 2024. This primarily
reflected contribution from Total comprehensive income for the period partly
offset by dividends paid to shareholders.
At 30 June 2024, the net deficit on the Group's pension plans was £597
million compared with £764 million at 31 December 2023. This decrease in the
net deficit is primarily due to increases in the UK and US discount rates,
partially offset by lower UK asset values and an increase to the US cash
balance credit rate.
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 £918 million (31 December 2023: £848 million).
Contingent consideration amounted to £7,138 million at 30 June 2024 (31
December 2023: £6,662 million), of which £5,927 million (31 December 2023:
£5,718 million) represented the estimated present value of amounts payable to
Shionogi relating to ViiV Healthcare, £566 million (31 December 2023: £424
million) represented the estimated present value of contingent consideration
payable to Novartis related to the Vaccines acquisition, £536 million (31
December 2023: £516 million) represented the estimated present value of
contingent consideration payable to Affinivax, and £98 million (31 December
2023: £nil) represented the estimated present value of contingent
consideration payable in relation to the Aiolos acquisition. Of the contingent
consideration payable to Shionogi at 30 June 2024, £1,048 million (31
December 2023: £1,017 million) is expected to be paid within one year.
Movements in contingent consideration are as follows:
H1 2024 ViiV Group
Healthcare £m
£m
Contingent consideration at beginning of the period 5,718 6,662
Additions - 104
Remeasurement through income statement and other movements 814 998
Cash payments: operating cash flows (605) (619)
Cash payments: investing activities - (7)
Contingent consideration at end of the period 5,927 7,138
H1 2023 ViiV Group
Healthcare £m
£m
Contingent consideration at beginning of the period 5,890 7,068
Remeasurement through income statement and other movements (73) (262)
Cash payments: operating cash flows (565) (575)
Cash payments: investing activities - (4)
Contingent consideration at end of the period 5,252 6,227
Business acquisitions
On 9 January 2024, GSK announced it had entered into an agreement to acquire
100% of Aiolos Bio, Inc. (Aiolos), a clinical stage biopharmaceutical company
focused on addressing the unmet treatment needs of patients with certain
respiratory and inflammatory conditions, for a total consideration of
US$1,004 million (£800 million) as adjusted for working capital acquired
paid upon closing and up to US$400 million (£319 million) in certain
success-based regulatory milestone payments. The estimated fair value of the
contingent consideration payable was US$120 million (£96 million). In
addition, GSK will also be responsible for success-based milestone payments as
well as tiered royalties owed to Jiangsu Hengrui Pharmaceuticals Co., Ltd.
(Hengrui). The acquisition completed on 14 February 2024. The values in the
table below are provisional and subject to change.
Goodwill of £191 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 886
Cash and cash equivalents 23
Other net liabilities (16)
Deferred tax liabilities (188)
705
Goodwill 191
Total consideration 896
Of the £896 million consideration, £121 million was unpaid as at 30 June
2024 of which £96 million relates to the contingent consideration.
On 6 June 2024, GSK announced that it had acquired Elsie Biotechnologies, a
San Diego-based private biotechnology company dedicated to unlocking the full
potential of oligonucleotide therapeutics, for a total cash consideration of
up to US$51 million (approximately £40 million). The acquisition is
accounted for as a business combination but is not considered a significant
acquisition for the Group. This agreement is not subject to closing conditions
and the acquisition has been completed.
Net debt information
Reconciliation of cash flow to movements in net debt
H1 2024 H1 2023
£m £m
Total Net debt at beginning of the period (15,040) (17,197)
Increase/(decrease) in cash and bank overdrafts 48 (299)
Increase/(decrease) in liquid investments (22) -
Net (increase)/repayment of short-term loans 862 (1,594)
Repayment of long-term notes - 150
Repayment of lease liabilities 114 94
Net debt of subsidiary undertakings acquired - 49
Exchange adjustments 97 660
Other non-cash movements (19) (83)
(Increase)/decrease in net debt 1,080 (1,023)
Total Net debt at end of the period (13,960) (18,220)
Net debt analysis
30 June 2024 31 December 2023
£m £m
Liquid investments 21 42
Cash and cash equivalents 2,962 2,936
Short-term borrowings (3,366) (2,813)
Long-term borrowings (13,577) (15,205)
Total Net debt at the end of the period (13,960) (15,040)
Free cash flow reconciliation
Q2 2024 Q2 2023 H1 2024 H1 2023
£m £m £m £m
Net cash inflow/(outflow) from operating activities 1,113 1,307 2,071 1,360
Purchase of property, plant and equipment (302) (296) (550) (529)
Proceeds from sale of property, plant and equipment 2 3 3 10
Purchase of intangible assets (140) (239) (455) (535)
Proceeds from disposals of intangible assets 1 8 28 12
Net finance costs (247) (295) (281) (386)
Dividends from associates and joint ventures 15 - 15 1
Contingent consideration paid (reported in investing activities) (4) (3) (7) (4)
Distributions to non-controlling interests (111) (137) (208) (277)
Contributions from non-controlling interests 1 - 1 7
Free cash inflow/(outflow) 328 348 617 (341)
Post balance sheet event
GSK and CureVac N.V. announced on 3 July 2024 that they have restructured
their existing collaboration into a new licensing agreement, allowing each
company to prioritise investment and focus their respective mRNA development
activities. GSK acquired the full rights to develop, manufacture and
commercialise globally mRNA candidate vaccines for influenza and COVID-19,
including combinations. CureVac will receive €400 million upfront and
potentially up to an additional €1.05 billion in development, regulatory and
sales milestone payments as well as tiered royalties; all previous financial
considerations from the prior collaboration agreement are replaced.
Following completion of customary closing conditions, as well as certain
antitrust and regulatory approvals, the deal was closed on 11 July 2024.
Related party transactions
Details of GSK's related party transactions are disclosed on page 235 of our
2023 Annual Report.
Financial instruments fair value disclosures
The following tables categorise the Group's financial assets and liabilities
held at fair value by the valuation methodology applied in determining their
fair value. Where possible, quoted prices in active markets are used and the
asset or liability is classified as Level 1. Where such prices are not
available, the asset or liability is classified as Level 2, provided all
significant inputs to the valuation model used are based on observable market
data. If one or more of the significant inputs to the valuation model is not
based on observable market data, the instrument is classified as Level 3.
Other investments classified as Level 3 in the tables below comprise equity
investments in unlisted entities with which the Group has entered into
research collaborations and also investments in emerging life science
companies.
At 30 June 2024 Level 1 Level 2 Level 3 Total
£m £m £m £m
Financial assets at fair value
Financial assets at fair value through other comprehensive
income (FVTOCI):
Other investments designated at FVTOCI 667 - 194 861
Trade and other receivables - 2,258 - 2,258
Financial assets mandatorily at fair value through
profit or loss (FVTPL):
Current equity investments and Other investments - - 238 238
Other non-current assets - - 16 16
Trade and other receivables - 31 2 33
Held for trading derivatives that are not in a - 26 - 26
designated and effective hedging relationship
Cash and cash equivalents 1,338 - - 1,338
Derivatives designated and effective as hedging - 58 - 58
instruments (FVTOCI)
2,005 2,373 450 4,828
Financial liabilities at fair value
Financial liabilities mandatorily at fair value through profit or
loss (FVTPL):
Contingent consideration liabilities - - (7,138) (7,138)
Held for trading derivatives that are not in a - (73) - (73)
designated and effective hedging relationship
Derivatives designated and effective as hedging - (30) - (30)
instruments (FVTOCI)
- (103) (7,138) (7,241)
At 31 December 2023 Level 1 Level 2 Level 3 Total
£m £m £m £m
Financial assets at fair value
Financial assets at fair value through other comprehensive
income (FVTOCI):
Other investments designated at FVTOCI 741 - 190 931
Trade and other receivables - 2,541 - 2,541
Financial assets mandatorily at fair value through profit or loss
(FVTPL):
Current equity investments and Other investments 2,204 - 206 2,410
Other non-current assets - - 18 18
Trade and other receivables - 23 - 23
Held for trading derivatives that are not in a - 98 - 98
designated and effective hedging relationship
Cash and cash equivalents 994 - - 994
Derivatives designated and effective as hedging - 32 - 32
instruments (FVTOCI)
3,939 2,694 414 7,047
Financial liabilities at fair value
Financial liabilities mandatorily at fair value through profit or
loss (FVTPL):
Contingent consideration liabilities - - (6,662) (6,662)
Held for trading derivatives that are not in a - (78) - (78)
designated and effective hedging relationship
Derivatives designated and effective as hedging - (36) - (36)
instruments (FVTOCI)
- (114) (6,662) (6,776)
Movements in the six months to 30 June 2024 and the six months to 30 June 2023
for financial instruments measured using Level 3 valuation methods are
presented below:
Financial Financial
assets liabilities
£m £m
At 1 January 2024 414 (6,662)
Gains/(losses) recognised in the income statement 22 (995)
Gains/(losses) recognised in other comprehensive income (18) -
Additions 50 (104)
Disposals and settlements (18) -
Payments in the period - 626
Exchange adjustments - (3)
At 30 June 2024 450 (7,138)
At 1 January 2023 657 (7,068)
Gains/(losses) recognised in the income statement (88) 262
Gains/(losses) recognised in other comprehensive income (149) -
Additions 30 -
Disposals and settlements (17) -
Transfer from Level 3 (8) -
Payments in the period - 579
Exchange adjustments (24) -
At 30 June 2023 401 (6,227)
Net losses of £973 million (H1 2023: £174 million net gains) reported in
other operating income were attributable to Level 3 financial instruments held
at the end of the period. Net gains and losses include the impact of exchange
movements.
Financial liabilities measured using Level 3 valuation methods at 30 June 2024
primarily included £5,927 million (31 December 2023: £5,718 million) of
contingent consideration for the acquisition in 2012 of the former
Shionogi-ViiV Healthcare joint venture, £566 million (31 December 2023: £424
million) of contingent consideration for the acquisition of the Novartis
Vaccines business in 2015 and £536 million (31 December 2023: £516 million)
of contingent consideration payable for the acquisition of Affinivax in 2022.
Contingent consideration is expected to be paid over a number of years and
will vary in line with the future performance of specified products, the
achievement of certain milestone targets and movements in certain foreign
currencies.
The financial liabilities are measured at the present value of expected future
cash flows, the most significant inputs and assumptions in the valuation
models being future sales forecasts, probability of milestone success, the
discount rate, the Sterling/US Dollar exchange rate and the Sterling/Euro
exchange rate. The exchange rates used are consistent with market rates at 30
June 2024.
The Shionogi-ViiV Healthcare contingent consideration liability is discounted
at 8% (31 December 2023: 8%), the Affinivax contingent consideration liability
is discounted at 9% (31 December 2023: 8.5%) and the Novartis Vaccines
contingent consideration liability is discounted at 8% (31 December 2023:
7.5%) for commercialised products and at 9% (31 December 2023: 8.5%) for
pipeline assets.
The Shionogi-ViiV Healthcare and Novartis Vaccines contingent consideration
liabilities are calculated principally based on the forecast sales performance
of specified products over the lives of those products.
The Affinivax contingent consideration is based upon two potential milestone
payments, each of $0.6 billion (£0.5 billion) which will be paid if certain
paediatric clinical development milestones are achieved
The table below shows, on an indicative basis, the income statement and
balance sheet sensitivity to reasonably possible changes in key inputs to the
valuation of the largest contingent consideration liabilities.
Increase/(decrease) in liability Shionogi- Novartis Affinivax
ViiV Vaccines contingent
Healthcare contingent consideration
contingent consideration £m
consideration £m
£m
10% increase in sales forecasts* 588 83 N/A
15% increase in sales forecasts* 881 125 N/A
10% decrease in sales forecasts* (586) (83) N/A
15% decrease in sales forecasts* (879) (124) N/A
10% increase in probability of milestone success N/A 20 78
10% decrease in probability of milestone success N/A (10) (78)
1% increase in discount rate (190) (40) (10)
1.5% increase in discount rate (282) (58) (15)
1% decrease in discount rate 207 47 11
1.5% decrease in discount rate 315 73 16
10 cent appreciation of US Dollar 414 14 46
15 cent appreciation of US Dollar 648 22 72
10 cent depreciation of US Dollar (352) (12) (39)
15 cent depreciation of US Dollar (510) (17) (57)
10 cent appreciation of Euro 85 22 N/A
15 cent appreciation of Euro 131 35 N/A
10 cent depreciation of Euro (70) (19) N/A
15 cent depreciation of Euro (102) (27) N/A
* The sales forecasts for the Shionogi-ViiV Healthcare contingent consideration
are for ViiV Healthcare sales only.
The Group transfers financial instruments between different levels in the fair
value hierarchy when, as a result of an event or change in circumstances, the
valuation methodology applied in determining their fair values alters in such
a way that it meets the definition of a different level. There were no
transfers between the Level 1 and Level 2 fair value measurement categories.
The following methods and assumptions are used to measure the fair value of
the significant financial instruments carried at fair value on the balance
sheet:
• Current equity investments and Other investments - equity investments traded
in an active market determined by reference to the relevant stock exchange
quoted bid price; other equity investments determined by reference to the
current market value of similar instruments, recent financing rounds or the
discounted cash flows of the underlying net assets
• Trade receivables carried at fair value - based on invoiced amount, which is
not materially different to the present value of future cash flows
• Interest rate swaps, foreign exchange forward contracts, swaps and options -
based on the present value of contractual cash flows or option valuation
models using market-sourced data (exchange rates or interest rates) at the
balance sheet date
• Cash and cash equivalents carried at fair value - based on net asset value of
the funds
• Contingent consideration for business acquisitions and divestments - based on
present values of expected future cash flows
There are no material differences between the carrying value of the Group's
other financial assets and liabilities and their estimated fair values, with
the exception of bonds, for which the carrying values and fair values are set
out in the table below:
30 June 2024 31 December 2023
Carrying Fair Carrying Fair
value value value value
£m £m £m £m
Bonds in a designated hedging relationship (5,191) (5,011) (5,348) (5,233)
Other bonds (9,716) (9,585) (10,456) (10,762)
(14,907) (14,596) (15,804) (15,995)
The following methods and assumptions are used to estimate the fair values of
financial assets and liabilities which are not measured at fair value on the
balance sheet:
• Receivables and payables, including put options over non-controlling interests
carried at amortised cost - approximates to the carrying amount
• Liquid investments - approximates to the carrying amount
• Cash and cash equivalents carried at amortised cost - approximates to the
carrying amount
• Short-term loans, overdrafts and commercial paper - approximates to the
carrying amount because of the short maturity of these instruments
• Long-term loans (European and US Medium Term Notes) - based on quoted market
prices (a Level 1 fair value measurement); approximates to the carrying amount
in the case of floating rate bank loans
Other payables in Current liabilities includes the present value of the
expected redemption amount of the Pfizer put option over its non-controlling
interest in ViiV Healthcare of £918 million (31 December 2023: £848
million). This reflects a number of assumptions around future sales, profit
forecasts and the Sterling/US Dollar exchange rate and the Sterling/Euro
exchange rate. The exchange rates used are consistent with market rates at 30
June 2024.
The table below shows on an indicative basis the income statement and balance
sheet sensitivity to reasonably possible changes in the key inputs to the
measurement of this liability.
Increase/(decrease) in liability ViiV
Healthcare
put option
£m
10% increase in sales forecasts* 92
15% increase in sales forecasts* 138
10% decrease in sales forecasts* (92)
15% decrease in sales forecasts* (138)
1% increase in discount rate (23)
1.5% increase in discount rate (33)
1% decrease in discount rate 24
1.5% decrease in discount rate 36
10 cent appreciation of US Dollar 65
15 cent appreciation of US Dollar 103
10 cent depreciation of US Dollar (56)
15 cent depreciation of US Dollar (81)
10 cent appreciation of Euro 24
15 cent appreciation of Euro 37
10 cent depreciation of Euro (20)
15 cent depreciation of Euro (29)
* The sales forecasts for the ViiV Healthcare put option are for the ViiV
Healthcare sales only.
R&D commentary
Pipeline overview
Medicines and vaccines in phase III development (including major lifecycle 18 Infectious Diseases (7)
innovation or under regulatory review)
• Arexvy (RSV vaccine) RSV older adults (50-59 years of age at increased risk
(AIR))
• gepotidacin (bacterial topoisomerase inhibitor) uncomplicated urinary tract
infection and urogenital gonorrhoea
• bepirovirsen (HBV ASO) hepatitis B virus
• Bexsero infants vaccine (US)
• MenABCWY (gen 1) vaccine candidate
• tebipenem pivoxil (antibacterial carbapenem) complicated urinary tract
infection
• ibrexafungerp (antifungal glucan synthase inhibitor) invasive candidiasis
Respiratory/Immunology (6)
• 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
Total vaccines and medicines in all phases of clinical development 70
Total projects in clinical development (inclusive of all phases and 91
indications)
Our key growth assets by therapy area
The following outlines several key vaccines and medicines by therapy area that
will help drive growth for GSK to meet its outlooks for 2021-2026 and beyond.
Infectious Diseases
Arexvy (respiratory syncytial virus vaccine, adjuvanted)
In June 2024, the US FDA approved Arexvy for the prevention of RSV in adults
50 to 59 years of age who are at increased risk. However, the US Advisory
Committee on Immunization Practices postponed its vote for use in this
population, requesting additional data. The Committee also recommended the use
of Arexvy in all adults aged 75 and over and for adults aged 60-74 who are at
increased risk from severe RSV disease, which was a change to the prior
recommendation in adults aged 60 and older with shared clinical decision
making.
In July 2024, the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) adopted a positive opinion recommending extending the
vaccine's approval for the prevention of RSV-LRTD from adults aged 60 and
above to include adults aged 50-59 years at increased risk for RSV disease.
This is one of the final steps prior to the extension of the marketing
authorisation by the European Commission.
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: Active, not recruiting; 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
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
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
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,
compared to older adults ≥60 years of age
NCT05590403 Primary data reported:
Q4 2023
RSV OA=ADJ-019 III An open-label, randomised, controlled, multi-country trial to evaluate the Trial start: Complete
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
Data anticipated:
NCT05879107 H2 2024
RSV OA=ADJ-023 IIb A randomised, controlled, open-label trial to evaluate the immune response and Trial start: Active, not recruiting
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 Data anticipated:
NCT05921903 H2 2024
RSV-OA=ADJ-020 III A study on the safety and immune response of investigational RSV OA vaccine in Trial start: Active, not recruiting
combination with herpes zoster vaccine in healthy adults
(Adults aged >=50 years of age) Q3 2023
NCT05966090 Data anticipated:
H2 2024
RSV-OA=ADJ-013 III An open-label, randomized, controlled study to evaluate the immune response, Trial start: 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 Data anticipated:
H2 2024
RSV OA=ADJ-025 IIIb An open-label study to evaluate the non-inferiority of the immune response and Trial start: Recruiting
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 18-49 years of age at increased risk for Respiratory Syncytial Virus disease, Q2 2024
adults participants, >=60 YOA) compared to older adults >=60 years of age
Data anticipated:
NCT06389487
H2 2024
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 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.
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
Data anticipated: 2026+
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
Data anticipated: 2026+
bepirovirsen sequential combination therapy with targeted immunotherapy II A trial on the safety, efficacy and immune response following sequential Trial start: Active, not recruiting
treatment with an anti-sense oligonucleotide against chronic hepatitis B (CHB)
(chronic hepatitis B) and chronic hepatitis B targeted immunotherapy (CHB-TI) in CHB patients Q2 2022
receiving nucleos(t)ide analogue (NA) therapy
NCT05276297 Data anticipated: 2026+
gepotidacin (bacterial topoisomerase inhibitor)
Gepotidacin is an investigational bactericidal, first-in-class antibiotic with
a novel mechanism of action for the treatment of uncomplicated urinary tract
infections (uUTI) and urogenital gonorrhoea. Positive data from three pivotal
trials demonstrate its potential to provide a new oral treatment option for
patients, including against drug resistant infections. Regulatory submissions
in uUTI are planned for H2 2024, with filings for gonorrhoea expected to
follow in 2025. If approved, gepotidacin could be the first in a new class of
oral antibiotics in uUTI in over 20 years.
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
MenABCWY vaccine candidate
GSK's 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate combines the
antigenic components of its two well-established meningococcal vaccines with
demonstrated efficacy and safety profiles, Bexsero (Meningococcal Group B
Vaccine) and Menveo (Meningococcal Groups A, C, Y, and W-135). Combining the
protection offered by these vaccines aims to reduce the number of injections,
simplifying immunisation and potentially increasing series completion and
vaccination coverage of adolescents and young adults. A Biologics License
Application (BLA) is currently under review by the US FDA with a Prescription
Drug User Fee Act (PDUFA) action date of 14 February 2025. In June 2024,
safety and immunogenicity data were presented at the CDC's ACIP meeting ahead
of a potential vote in February 2025.
Key trials for MenABCWY vaccine candidate:
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
HIV
cabotegravir
GSK continues to advance its early-stage HIV pipeline focused on innovative
long-acting injectable regimens and expects cabotegravir to increasingly
replace dolutegravir as the foundational integrase inhibitor in its portfolio.
In July 2024, positive data from the PASO DOBLE study, the largest
head-to-head randomised clinical trial of Dovato compared against the
three-drug-regimen Biktarvy, were presented at the AIDS congress. The study
met its primary endpoint with Dovato showing non-inferior efficacy and
significantly less weight gain than the three-drug-regimen.
First-time-in-human data for GSK's third-generation integrase inhibitor,
VH184, were also shared. These demonstrated strong efficacy and a unique
resistance profile, reinforcing integrase inhibitors as the gold standard in
HIV and supporting further development of VH184 as an option for long-acting
therapies. GSK has also committed to progress phase III trials for ULA Q4M
PrEP and selected rilpivirine as the partner for CAB ULA in Q4M treatment.
This regimen selection is based on progress in formulation studies for
rilpivirine and builds on existing positive patient and physician experience
with these medicines. Four monthly dosing options are on track to be
delivered for prevention in 2026 and for treatment in 2027, in line with the
ambition to extend the dosing interval of long-acting regimens to enable
every-six monthly dosing towards the end of the decade.
Respiratory/Immunology
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
Data anticipated:
2025
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
Data anticipated:
2025
depemokimab (long acting anti-IL5)
Depemokimab is in late-stage development for severe asthma, chronic
rhinosinusitis with nasal polyps (CRSwNP), hypereosinophilic syndrome (HES)
and eosinophilic granulomatosis with polyangiitis (EGPA). Depemokimab is the
first ultra-long-acting biologic engineered to have a binding affinity and
high potency for IL-5, resulting in an extended half-life and enabling
six-month dosing intervals for patients with severe asthma.
The phase III programme for depemokimab continues to make progress across a
range of IL-5 mediated conditions. In May 2024, positive data were reported
from the pivotal SWIFT-1 and SWIFT-2 trials evaluating the efficacy and safety
of depemokimab in severe asthma with type 2 inflammation. Both trials met
their primary endpoints with depemokimab showing statistically significant and
clinically meaningful reductions in exacerbations (asthma attacks) over 52
weeks vs. placebo. Full results will be presented at an upcoming scientific
congress. Further phase III data from ANCHOR-1 and ANCHOR-2, assessing the
safety and efficacy of depemokimab in patients with CRSwNP are expected to
read out in H2 2024. This data will be used to support regulatory submissions
to health authorities worldwide.
Key phase III trials for depemokimab:
Trial name (population) Phase Design Timeline Status
SWIFT-1 (severe eosinophilic 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 eosinophilic 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 (SEA) 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)
Data anticipated:
2025
NIMBLE (SEA) III A 52-week, randomised, double-blind, double-dummy, parallel group, Trial start: 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
Data anticipated:
2025
ANCHOR-1 (chronic rhinosinusitis with nasal polyps; CRSwNP) III Efficacy and safety of depemokimab in participants with CRSwNP Trial start: Active, not recruiting
Q2 2022
NCT05274750
Data anticipated:
H2 2024
ANCHOR-2 (CRSwNP) III Efficacy and safety of depemokimab in participants with CRSwNP Trial start: Active, not recruiting
Q2 2022
NCT05281523
Data anticipated:
H2 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 Data anticipated:
2025
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 Data anticipated:
2026+
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.
The MATINEE phase III trial investigating Nucala in patients with chronic
obstructive pulmonary disease (COPD) is expected to readout in the second half
of 2024.
Key phase 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: Active, not recruiting
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 anticipated:
H2 2024
Oncology
Blenrep (belantamab mafodotin)
GSK continues to explore the potential for Blenrep 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.
In June 2024, positive results from the DREAMM-8 phase III head-to-head trial
were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual
Meeting and simultaneously published in the New England Journal of Medicine.
The trial met its primary endpoint of progression-free survival (PFS), with
belantamab mafodotin, in combination with pomalidomide plus dexamethasone
(PomDex) showing a statistically significant and clinically meaningful
reduction of nearly 50% in the risk of disease progression or death versus a
standard of care, bortezomib plus PomDex. Median PFS was not yet reached with
the belantamab mafodotin combination compared to 12.7 months in the bortezomib
combination. At the end of one year, 71% of patients in the belantamab
mafodotin combination group compared to 51% in the bortezomib combination
group were alive and had not progressed. A positive overall survival (OS)
trend was observed but not statistically significant, with OS follow-up
ongoing.
DREAMM-8 is the second phase III head-to-head belantamab mafodotin combination
trial to show robust efficacy in relapsed/refractory multiple myeloma,
following the presentation of results from the DREAMM-7 trial at an ASCO
virtual plenary in February 2024 and publication of those results in June in
the New England Journal of Medicine.
The pivotal data from DREAMM-7 and DREAMM-8 will serve as the basis for
intended regulatory filings for new indications for belantamab mafodotin,
anticipated in the US, EU, Japan and China by the end of 2024. In July 2024,
GSK announced that the European Medicines Agency accepted the marketing
authorisation application for belantamab mafodotin combinations for the
treatment of relapsed/refractory multiple myeloma in the EU.
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: 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: 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
Jemperli (dostarlimab)
Jemperli (dostarlimab) is the foundation of GSK's ongoing
immuno-oncology-based research and development programme. In June 2024, the
European Medicines Agency accepted a regulatory application to extend use of
Jemperli (dostarlimab) in combination with standard-of-care chemotherapy
(carboplatin and paclitaxel) to all adult patients with primary advanced or
recurrent endometrial cancer, with a decision expected in H1 2025.
Dostarlimab is also being studied in several other cancers. In June 2024, GSK
announced updated, longer-term results from the phase II supported
collaborative study with Memorial Sloan Kettering Cancer Center evaluating
dostarlimab as a first-line treatment alternative to surgery, radiation and
chemotherapy for mismatch repair deficient (dMMR) locally advanced rectal
cancer. The trial showed an unprecedented 100% clinical complete response rate
(cCR) in 42 patients who completed treatment with dostarlimab, defined as
complete pathologic response or no evidence of tumours as assessed by magnetic
resonance imaging, endoscopy and digital rectal exam. In the first 24 patients
evaluated, a sustained cCR with a median follow-up of 26.3 months (95% CI:
12.4-50.5) was observed.
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: Active, not recruiting; 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: Recruiting
with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Q1 2023
NCT05723562
Data anticipated: 2026
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
dMMR/MSI-H resectable colon cancer Q3 2023
NCT05855200
Data anticipated: 2026+
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
have progressed on prior anti-PD-(L)1 therapy and chemotherapy
NCT04655976
Data anticipated:
2025
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
Data anticipated: 2026+
Ojjaara/Omjjara (momelotinib)
With its differentiated mechanism of action, Ojjaara has become a backbone
therapy in myelofibrosis (MF) and a new standard of care for MF patients with
anaemia. In June 2024, the Ministry of Health, Labour and Welfare (MHLW)
approved momelotinib under the brand name Omjjara for the treatment of
myelofibrosis in Japan. GSK continues to pursue regulatory submissions and
approvals for momelotinib in myelofibrosis across the globe, as well as to
evaluate its potential in combinations and other areas of unmet need.
Key phase III trial for momelotinib:
Trial name (population) Phase Design Timeline Status
MOMENTUM (myelofibrosis) III A randomised, double-blind, active control phase III trial intended to confirm Trial start: Complete; primary endpoint met
the differentiated clinical benefits of the investigational drug momelotinib
(MMB) versus danazol (DAN) in symptomatic and anaemic subjects who have Q1 2020
previously received an approved Janus kinase inhibitor (JAKi) therapy for
NCT04173494 myelofibrosis (MF)
Primary data reported:
Q1 2022
Zejula (niraparib)
GSK continues to assess the potential of Zejula across multiple tumour types
and in combination with other agents. 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 trial of niraparib plus
pembrolizumab in advanced/metastatic non-small cell lung cancer. In addition,
niraparib is being evaluated in patients with newly diagnosed, MGMT
unmethylated glioblastoma in a recently initiated phase III trial sponsored by
the Ivy Brain Tumor Center and supported by GSK.
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
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 anticipated:
H2 2024
FIRST (1L ovarian cancer maintenance) III A randomised, double-blind, comparison of platinum-based therapy with Trial start: Active, not recruiting
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 anticipated:
H2 2024
Principal risks and uncertainties
The principal risks and uncertainties affecting the Group for 2024 are those
described under the headings below. These are not listed in order of
significance. In our December 2023 annual risk review, the Audit & Risk
Committee agreed our principal risks for 2024, which remain largely unchanged.
We describe our risk management process on pages 57-58 of our 2023 Annual
Report, along with more detailed information on our risks, including
definitions, trends, potential impact, context and mitigation activities as
set out on pages 59-61 and pages 284-294 of our 2023 Annual Report.
Other risks, not at the level of principal risk, and opportunities, related to
Environmental, Social, and Governance (ESG), including environmental
sustainability and climate change, are managed through our six focus areas, as
described in our 2023 ESG Performance Report. Additional information on
climate related risk management is in our climate related financial disclosure
on pages 62-75 of our 2023 Annual Report.
2024 Principal Risks
Enterprise Risk Title Definition
Patient safety The risk that GSK, including our third parties, fails to appropriately
collect, assess, follow up, or report human safety information, including
adverse events, from all potential sources or that GSK potentially fails to
appropriately act on any relevant findings that may affect the benefit-risk
profile of a medicine or vaccine in a timely manner.
Product quality The risk that GSK or our third parties potentially fail to ensure appropriate
controls and governance of quality for development and commercial products are
in place; compliance with industry practices and regulations in manufacturing
and distribution activities; and terms of GSK product licenses and supporting
regulatory activities are met.
Financial controls and reporting The risk that GSK fails to comply with current tax laws; fails to report
accurate financial information in compliance with accounting standards and
applicable legislation; or incurs significant losses due to treasury
activities.
Legal matters The risk that GSK or our third parties potentially fail to comply with certain
legal requirements for the development and management of our pipeline, supply
and commercialisation of our products and operation of business, and
specifically in relation to requirements for competition law, anti-bribery and
corruption, and sanctions. Any failure to meet compliance and legal standards
for these particular areas could lead to increasing scrutiny and enforcement
from government agencies.
Commercial practices The risk that GSK or our third parties potentially engage in commercial
activities that fail to comply with laws, regulations, industry codes, and
internal controls and requirements.
Scientific and patient engagement The risk that GSK or our third parties potentially fail to engage externally
to gain insights, educate and communicate on the science of our medicines and
associated disease areas, and provide healthcare and patient support, grants
and donations in a legitimate and transparent manner compliant with laws,
regulations, industry codes and internal controls and requirements.
Data ethics and privacy The risk that GSK or our third parties potentially fail to ethically collect;
use; re-use through artificial intelligence, data analytics or automation;
secure; share and destroy personal information in accordance with laws,
regulations, and internal controls and requirements.
Research practices The risk that GSK or our third parties potentially fail to adequately conduct
ethical and credible pre-clinical and clinical research, collaborate in
research activities compliant with laws, regulations, and internal controls
and requirements.
Environment, health and safety (EHS) The risk that GSK or our third parties potentially fail to ensure appropriate
controls and governance of the organisation's assets, facilities,
infrastructure, and business activities, including execution of hazardous
activities, handling of hazardous materials, or release of substances harmful
to the environment that disrupts supply or harms employees, third parties or
the environment.
Information and cyber security The risk that GSK or our third parties fail to ensure appropriate controls and
governance to identify, protect, detect, respond, and recover from cyber
security incidents in accordance with applicable laws, regulations, industry
standards, internal controls, and requirements. This could be due to
unauthorised access, disclosure, loss, theft, unavailability or corruption of
GSK's information, key systems, or technology infrastructure.
Supply continuity The risk that GSK or our third parties potentially fail to deliver a
continuous supply of compliant finished product or respond effectively to a
crisis incident in a timely manner to recover and sustain critical supply
operations.
Reporting definitions
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 18 and other non-IFRS measures are
defined below.
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 reflecting depreciation of their respective
currencies in order to provide comparability and not to distort CER growth
rates.
£% or AER% represents growth at actual exchange rates.
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 44.
Free cash flow conversion
Free cash flow conversion is free cash flow from operations as a percentage of
profit attributable to shareholders.
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.
COVID-19 solutions
COVID-19 solutions include the sales of pandemic adjuvant and other COVID-19
solutions during the years from 2020-2023 and includes vaccine manufacturing
and Xevudy and the associated costs but does not include reinvestment in
R&D. This categorisation is used by management who believe it is helpful
to investors through providing clarity on the results of the Group by showing
the contribution to growth from COVID-19 solutions during this period.
Turnover excluding COVID-19 solutions
Turnover excluding COVID-19 solutions excludes the impact of sales of pandemic
adjuvant within Vaccines and Xevudy within Specialty Medicines related to the
COVID-19 pandemic during the years 2020-2023. Management believes that the
exclusion of the impact of these COVID-19 solutions sales aids comparability
in the reporting periods and understanding of GSK's growth including by region
versus prior periods and also 2024 Guidance which excludes any contributions
from COVID-19 solutions in current year or comparator periods.
Non-controlling interest
Non-controlling interest is the equity in a subsidiary not attributable,
directly or indirectly, to a parent.
Working capital
Working capital represents inventory and trade receivables less trade
payables.
Total Operating Margin
Total Operating margin is Total operating profit divided by turnover.
Core Operating Margin
Core Operating margin is Core operating profit divided by turnover.
Total Earnings per share
Unless otherwise stated, Total earnings per share refers to Total basic
earnings per share.
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.
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.
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 Other and Oncology.
Percentage points
Percentage points of growth which is abbreviated to ppts.
Year to date
Year to date is the six-month period in the year to 30 June 2024 or the same
prior period in 2023 as appropriate.
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
2024 Guidance
GSK expects 2024 turnover to increase between 7 to 9 per cent (previously 5 to
7 per cent) and Core Operating profit to increase between 11 to 13 per cent
(previously 9 to 11 per cent). Core Earnings per share is expected to increase
between 10 to 12 per cent (previously 8 to 10 per cent).
The Group revises turnover expectations for Vaccines to an increase of low to
mid-single digit per cent, for Specialty Medicines an increase of mid to high
teens per cent and for General Medicines an increase of low to mid-single
digit per cent.
This guidance is provided at CER and excludes any contribution from COVID-19
related solutions.
Assumptions and basis of preparation related to 2024 guidance
In outlining the guidance for 2024, the Group has made certain planning
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.
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 as a result of government or competitor action.
The 2024 guidance factors in all divestments and product exits announced to
date.
Notwithstanding our guidance, outlooks and expectations, there is still
uncertainty as to whether our assumptions, guidance, outlooks and expectations
will be achieved.
The guidance is given on a constant currency basis.
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 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 Q2 2024
earnings release and in the Group's 2023 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 2023. 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.
Directors' responsibility statement
The Board of Directors approved this Half-yearly Financial Report on 31 July
2024.
The Directors confirm that to the best of their knowledge the unaudited
condensed financial information has been prepared in accordance with IAS 34 as
contained in UK-adopted International Financial Reporting Standards (IFRS) and
that the interim management report includes a fair review of the information
required by DTR 4.2.7 and DTR 4.2.8.
After making enquiries, the Directors considered it appropriate to adopt the
going concern basis in preparing this Half-yearly Financial Report.
The Directors of GSK plc are as follows:
Sir Jonathan Symonds Non-Executive Chair, Nominations & Corporate Governance Committee Chair
Dame Emma Walmsley Chief Executive Officer (Executive Director)
Julie Brown Chief Financial Officer (Executive Director)
Elizabeth McKee Anderson Independent Non-Executive Director
Charles Bancroft Senior Independent Non-Executive Director, Audit & Risk Committee Chair
Dr Hal Barron Non-Executive Director
Dr Anne Beal Independent Non-Executive Director, Corporate Responsibility Committee Chair
Wendy Becker Independent Non-Executive Director, Remuneration Committee Chair
Dr Harry (Hal) Dietz Independent Non-Executive Director, Science Committee Chair
Dr Jesse Goodman Independent Non-Executive Director
Dr Jeannie Lee Independent Non-Executive Director
Dr Vishal Sikka Independent Non-Executive Director
By order of the Board
Emma Walmsley Julie Brown
Chief Executive Officer Chief Financial Officer
31 July 2024
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
and six months ended 30 June 2024.
The condensed financial information comprises:
• the income statement and statement of comprehensive income for the three and
six month periods ended 30 June 2024 on pages 26 and 27;
• the balance sheet as at 30 June 2024 on page 28;
• the statement of changes in equity for the six-month period then ended on page
29;
• the cash flow statement for the six-month period then ended on page 30; and
• the accounting policies and basis of preparation and the explanatory notes to
the condensed financial information on pages 31 to 49 that have been prepared
applying consistent accounting policies to those applied by GSK plc and its
subsidiaries ("the Group") in the Annual Report 2023, which was prepared in
accordance with International Financial Reporting Standards ("IFRS") as
adopted by the United Kingdom.
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 and six months ended 30 June 2024 is not prepared, in all
material respects, in accordance with United Kingdom adopted International
Accounting Standard 34 and the Disclosure Guidance and Transparency Rules of
the United Kingdom's Financial Conduct Authority.
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 41, 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 United Kingdom adopted
International Accounting Standard 34, "Interim Financial Reporting".
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
30 July 2024
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