REG - GSK PLC - 3rd Quarter Results
30/10/2024 07:00
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RNS Number : 1209K GSK PLC 30 October 2024
GSK on track to deliver 2024 outlooks with further good progress made in
R&D
Q3 2024 sales and core earnings growth driven by strong performance of
Specialty Medicines helping to offset lower Vaccines sales
• Total Q3 2024 sales £8.0 billion -2% AER; +2% CER
• Vaccines sales -15%. Shingrix -7% and Arexvy -72% reflecting ACIP guideline
changes, prioritisation of COVID vaccinations in the US and annualisation of
Arexvy launch in Q3 2023
• Specialty Medicines sales +19%. HIV sales +12%. Oncology +94%.
Respiratory/Immunology and other +14%
• General Medicines sales +7%. Trelegy +16%
• Total operating profit -86% and Total EPS -100% driven by a charge of £1.8
billion ($2.3 billion) in relation to the Zantac settlement
• Core operating profit +5% and Core EPS +5% reflecting strong Specialty
Medicines performance, together with effective cost management
• Cash generated from operations in the quarter £2.5 billion with Free cash
flow of £1.3 billion
(Financial Performance - Q3 2024 results unless otherwise stated, growth % and
commentary at CER as defined on page 52).
Q3 2024 Year to date
£m % AER % CER £m % AER % CER
Turnover 8,012 (2) 2 23,259 4 8
Turnover ex COVID 8,012 (2) 2 23,258 5 9
Total operating profit 189 (90) (86) 3,325 (46) (41)
Total operating margin % 2.4% (21.6ppts) (20.6ppts) 14.3% (13.4ppts) (12.5ppts)
Total EPS (1.4p) >(100) (100) 53.0p (53) (48)
Core operating profit 2,761 - 5 7,717 10 16
Core operating margin % 34.5% 0.4ppts 1.0ppts 33.2% 1.6ppts 2.2ppts
Core EPS 49.7p (1) 5 136.2p 8 14
Cash generated from operations 2,499 - 5,275 19
Further progress in R&D with growth prospects strengthened in all key
therapeutic areas:
• Infectious Diseases: EU approval for Arexvy in adults aged 50-59 at increased
risk, and positive new data indicates protection over three RSV seasons; US
FDA file acceptance for gepotidacin in uncomplicated UTI; bepirovirsen granted
SENKU designation in Japan for chronic hepatitis B
• HIV: Real-world studies demonstrate 99% effectiveness for Apretude, the only
approved long-acting medicine for HIV PrEP
• Respiratory/Immunology: Positive results announced for ultra long-acting
biologic, depemokimab, for phase III ANCHOR trial (CRSwNP)(1) and full results
for SWIFT-1&2 trials (severe asthma) supporting filing for severe asthma
and CRSwNP before year end with dual indication, potential launch in 2025.
Positive headline results announced for phase III MATINEE trial for Nucala in
COPD. Nucala approved in Japan for CRSwNP
• Oncology: Expanded US FDA approval for Jemperli in endometrial cancer; Blenrep
filed in US, EU and Japan and received Breakthrough Therapy Designation in
China; US FDA Breakthrough Therapy Designation for GSK5764227 (B7-H3-targeted
antibody-drug conjugate) in small-cell lung cancer
2024 guidance confirmed; Q3 2024 dividend of 15p declared and continue to
expect 60p full year dividend:
• 2024 turnover growth of 7% to 9%; Core operating profit growth of 11% to 13%;
Core EPS growth of 10% to 12%. Expected to deliver broadly around the middle
of existing ranges
Guidance all at CER and excluding COVID-19 solutions
Emma Walmsley, Chief Executive Officer, GSK:
"We have delivered another quarter of sales and core operating profit growth,
and further good progress in R&D. Strong growth in specialty medicines
helped to offset lower vaccine sales and reflected successful new product
launches in oncology and HIV, as well as the resilience we have now built into
GSK's portfolio and performance. Our pipeline continues to strengthen with 11
positive phase III trials reported so far this year and we are currently
planning launches for 5 major new product approval opportunities next year:
Blenrep, Depemokimab, Nucala for COPD, Gepotidacin, and our new vaccine to
prevent meningitis (MenABCWY). We also resolved the vast majority of Zantac
litigation in the quarter, to remove uncertainty and so we can focus forward.
All this means we are on track to deliver our 2024 guidance, and we are even
more confident in our 2026 and 2031 outlooks."
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 52: 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
54. (1) CRSwNP - Chronic rhinosinusitis with nasal polyps.
2024 Guidance
GSK confirms its full-year sales, core profit and EPS guidance at constant
exchange rates (CER) and expects to deliver broadly around the middle of the
existing ranges. All guidance, expectations and full-year growth rates exclude
any contributions from COVID-19 solutions.
Despite some challenges this quarter, particularly with lower than anticipated
vaccine demand and a tough comparator, GSK delivered growth in both sales and
core profits in the quarter at CER. Specialty Medicines continue to grow
strongly, 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 expected to grow between 7 to 9 per cent range at CER. Improved
sales performances in Specialty and General Medicines are expected to offset
lower sales growth of Vaccines this year, primarily due to lower sales of
Arexvy and Shingrix. Key factors driving Arexvy performance are guideline
restrictions, prioritisation of COVID vaccination in the US, and an
unfavourable comparison to the vaccine's outstanding launch last year.
All Guidance excludes the contributions of COVID-19 solutions Confirmed 2024 guidance at CER Previous 2024 guidance at CER
Turnover Increase between 7% to 9% Increase between 7% to 9%
Core operating profit Increase between 11% to 13% Increase between 11% to 13%
Core earnings per share Increase between 10% to 12% Increase between 10% to 12%
This guidance is supported by the following revised turnover expectations for
full-year 2024 at CER:
All turnover expectations exclude the contributions of COVID-19 solutions Revised 2024 guidance at CER Previous 2024 guidance at CER
Vaccines Decrease low-single digit per cent in turnover Increase low to mid-single digit per cent in turnover
Specialty Medicines Increase high teens per cent in turnover Increase mid to high teens per cent in turnover
General Medicines Increase mid-single digit per cent in turnover Increase low to mid-single digit per cent in turnover
Core operating profit is expected to grow between 11 to 13 per cent at CER.
This is 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 continues to be 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 royalty income is expected to be around £600 million
for the full year.
Core earnings per share is expected to increase between 10 to 12 percent at
CER. 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 has declared a dividend for Q3 2024 of 15p per share and expects
to declare a dividend of 60p per share for the full year 2024.
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 September 2024
($1.34/£1, €1.20/£1 and Yen 191/£1) for the rest of 2024, the estimated
impact on 2024 Sterling turnover growth for GSK would be -5% 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 -8%.
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 GMT (US EDT at 8 am)
on 30 October 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 Q3 2024 Year to date
£m Growth Growth £m Growth Growth
AER% CER% AER% CER%
Shingles 739 (10) (7) 2,516 (1) 2
Meningitis 520 18 22 1,142 16 20
RSV (Arexvy) 188 (73) (72) 432 (39) (37)
Influenza 283 (24) (22) 303 (26) (23)
Established Vaccines 920 6 10 2,533 2 5
Vaccines ex COVID 2,650 (18) (15) 6,926 (3) -
Pandemic vaccines - (100) >(100) - (100) (100)
Vaccines 2,650 (18) (15) 6,926 (5) (2)
HIV 1,750 8 12 5,120 10 13
Respiratory/Immunology and Other 843 10 14 2,389 10 15
Oncology 373 86 94 1,002 >100 >100
Specialty Medicines ex COVID 2,966 14 19 8,511 16 20
Xevudy - - - 1 (97) (97)
Specialty Medicines 2,966 14 19 8,512 16 20
Respiratory 1,617 6 11 5,407 6 11
Other General Medicines 779 (5) - 2,414 (6) (1)
General Medicines 2,396 3 7 7,821 2 7
Total 8,012 (2) 2 23,259 4 8
Total ex COVID 8,012 (2) 2 23,258 5 9
By Region:
US 4,321 (5) (1) 12,057 5 9
Europe 1,618 4 6 4,911 - 2
International 2,073 2 8 6,291 6 12
Total 8,012 (2) 2 23,259 4 8
Turnover ex COVID is excluding COVID-19 solutions during the years from 2020
to 2023 and is a non-IFRS measure defined on page 52 with the reconciliation
to the IFRS measure Turnover included in the table above. Financial
Performance - Q3 2024 results unless otherwise stated, growth % and commentary
at CER.
Q3 2024 Year to date
£m AER CER £m AER CER
Vaccines Total 2,650 (18%) (15%) 6,926 (5%) (2%)
Excluding COVID 2,650 (18%) (15%) 6,926 (3%) -%
In Q3 2024 and Total Vaccines sales decreased, while in YTD ex COVID sales
were broadly stable. Performance was primarily impacted by lower sales of
Arexvy with changes in ACIP guidelines, prioritisation of COVID-19
vaccinations in the quarter, lower seasonal infections and a tough comparator
following launch stocking last year. Shingrix decreased in the quarter, but
grew YTD, as lower demand in the US more than offset growth in International.
Meningitis vaccines continued to show strong demand with double-digit sales
growth. The overall Vaccines YTD performance was adversely impacted due to
COVID-19 solution sales in 2023.
Shingles 739 (10%) (7%) 2,516 (1%) 2%
Sales of Shingrix, a vaccine against herpes zoster (shingles), decreased in
the quarter, while continuing to grow YTD.
In the US, sales in the quarter decreased by 23%. The US cumulative
immunisation penetration rate at the end of Q2 2024 reached 39% of the more
than 120 million US adults(1) currently recommended to receive Shingrix, up
six percentage points(2) since the end of Q2 2023. However the pace of
increased penetration is slowing reflecting the continued challenge of
activating harder-to-reach consumers. Shingrix sales YTD were also negatively
impacted by changes in retail vaccine prioritisation in part due to a
transition to a new CMS(3) rule that changed how pharmacies process
reimbursements from payers.
Shingrix grew significantly in International in the quarter and YTD, driven by
a national immunisation programme in Australia and supply to our co-promotion
partner in China. In Europe, Shingrix decreased in the quarter and YTD from
lower demand in Germany partially offset by expanded public funding in other
countries. Markets outside the US now represent 58% of Q3 2024 global sales
(Q3 2023: 50%), with Shingrix launched in 48 countries. The overwhelming
majority of ex-US Shingrix opportunity is concentrated in 10 markets where
the average immunisation rate is around 6%.
Footnotes:
(1) United States Census Bureau, International Database, Year 2024 (2) Reflects
latest United States Census Bureau data and delivery orders (3) Centers for
Medicare & Medicaid Services
Q3 2024 Year to date
£m AER CER £m AER CER
Meningitis 520 18% 22% 1,142 16% 20%
In Q3 2024 and YTD, Meningitis vaccines grew double-digit achieving record
quarterly sales. Bexsero, a vaccine against meningitis B, grew primarily
reflecting Centers for Disease Control and Prevention (CDC) purchasing
patterns and favourable pricing mix in the US, recommendation in Germany and
the launch in Vietnam partly offset by tender phasing in Europe during H1
2024. Growth of Menveo, a vaccine against meningitis ACWY, benefitted from CDC
purchasing patterns in the US and favourable H1 2024 delivery timing in
International.
RSV (Arexvy) 188 (73%) (72%) 432 (39%) (37%)
Arexvy, a respiratory syncytial virus (RSV) vaccine for older adults, declined
in both the quarter and YTD. US sales in Q3 2024 decreased due to a more
restrictive recommendation from the Advisory Committee on Immunization
Practices (ACIP) for individuals aged 60 to 74, prioritisation of COVID
vaccinations related to a resurgence of COVID-19 infection rates and lower
channel inventory versus significant launch stocking in the prior year.
Arexvy maintained around two-thirds of the vaccination share YTD in retail
where the overwhelming majority of doses are administered. More than nine
million of the 85 million US adults(1) aged 60 and older at risk have been
protected by Arexvy since the launch in Q3 2023. The performance in YTD also
reflected new launch inventory build in Australia and Brazil, initial tender
deliveries in Saudi Arabia and continued consumer uptake in Canada. While
Arexvy is approved in 51 markets globally, 16 countries had national RSV
vaccination recommendations for older adults and 6, including the US, had
reimbursement programmes in place at the quarter end.
Influenza 283 (24%) (22%) 303 (26%) (23%)
Fluarix/FluLaval sales declined in Q3 2024 driven by competitive pressure and
volume phasing in the US and lower demand across other regions.
Established Vaccines 920 6% 10% 2,533 2% 5%
Established Vaccines grew in Q3 2024, reflecting favourable CDC purchasing
patterns across several paediatric brands together with increased demand for
Boostrix. This was partly offset by the timing of deliveries and competitive
pressure for Synflorix in International. YTD sales were also impacted by
adverse CDC stockpile movements for Rotarix and Infanrix/Pediarix in the US,
partly offset by increased supply of measles, mumps, rubella, and varicella
(MMR/V) vaccines in International.
Specialty Medicines Total 2,966 14% 19% 8,512 16% 20%
Excluding COVID 2,966 14% 19% 8,511 16% 20%
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 1,750 8% 12% 5,120 10% 13%
HIV sales grew double digits in both the quarter and YTD, primarily reflecting
a 2 percentage point increase in market share compared to the prior period.
This was driven by strong patient demand for Oral 2DR (Dovato, Juluca) and
long-acting medicines (Cabenuva, Apretude) and favourable in-year pricing,
including the positive impact from channel mix related to adjustments to
returns and rebates.
Oral 2DR 730 13% 17% 2,097 17% 21%
Sales of oral 2-drug regimens for the quarter were £730 million, which now
represents 42% of the total HIV portfolio. Dovato continues to be the highest
selling product in the HIV portfolio with sales of £567 million in the
quarter and growing 23% versus Q3 2023.
Long-Acting Medicines 314 43% 49% 898 54% 59%
Long-Acting Medicine sales in the quarter now represent 18% of the total HIV
portfolio compared to 13% for Q3 2023 and contributed over 50% of the total
HIV growth. Cabenuva sales reached £245 million in Q3 2024, growing 40% due
to strong patient demand. Apretude sales in Q3 2024 were £69 million, growing
95% compared to Q3 2023.
Respiratory/Immunology and Other 843 10% 14% 2,389 10% 15%
Sales primarily comprise contributions from Nucala in respiratory and Benlysta
in immunology. In Q3 2024, double digit sales growth continued for Nucala and
Benlysta, driven by patient demand globally across US, European and
International markets.
Footnote:
(1) United States Census Bureau, International Database, Year 2024
Q3 2024 Year to date
£m AER CER £m AER CER
Nucala 444 8% 12% 1,300 10% 14%
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 Q3 2024, sales growth continued to be
strong, particularly in Europe and International regions, reflecting higher
patient demand for treatments addressing eosinophilic-led disease.
Benlysta 389 11% 16% 1,067 11% 15%
Benlysta, a monoclonal antibody treatment for Lupus, continues to grow
consistently in Q3 2024, representing strong demand and volume growth in US,
European and International regions, with bio-penetration rates having
increased across many markets.
Oncology 373 86% 94% 1,002 >100% >100%
In Q3 2024, strong Oncology sales growth continued driven by increasing
patient demand for Zejula, a PARP(1) inhibitor, 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,
received US FDA approval in the quarter expanding the indication to include
all adult patients with primary advanced or recurrent endometrial cancer.
Jemperli sales continued to grow strongly with sales of £130 million
delivered in the quarter. Ojjaara/Omjjara, a treatment for myelofibrosis
patients with anaemia, launched in the US in Q3 2023, in the UK and Germany in
Q1 2024, and in Japan in Q3 2024, has seen strong uptake since launch and
delivered £98 million of sales in the quarter.
Zejula 144 3% 6% 450 21% 25%
Zejula, a PARP inhibitor treatment for ovarian cancer, continues to grow
globally across all regions with sustained increase in patient demand and
higher volumes, further enhanced by positive price impacts in the US. Growth
in the quarter was adversely impacted by channel inventory build associated
with the launch of the tablet formulation in the US in Q3 2023, partially
offset by favourable impacts from comparator adjustments to returns and
rebates.
General Medicines 2,396 3% 7% 7,821 2% 7%
Sales include contributions from both the Respiratory and Other General
Medicine portfolios. In Q3 2024, sales growth increased primarily driven by
Trelegy, a chronic obstructive pulmonary disease (COPD) and asthma medicine,
with strong demand across all regions. 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 1,617 6% 11% 5,407 6% 11%
In Q3 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 also grew in the quarter due to favourable
impacts from comparator adjustments in the US to return and rebates. 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 600 12% 16% 2,033 26% 31%
Trelegy is the most prescribed single inhaler triple therapy (SITT) treatment
worldwide for COPD and asthma. In Q3 2024 sales grew 16% with continued strong
growth across all regions, reflecting patient demand, single-inhaled triple
therapy class growth, and increased market share. YTD growth of 31% was
positively impacted by favourable US pricing impacts in the first six months
of 2024, including adjustments to return and rebates, which moderated in Q3
2024.
Seretide/Advair 218 8% 13% 798 (8%) (4%)
Seretide/Advair is a combination treatment used to treat asthma and COPD. In
Q3 2024, sales grew 13% reflecting growth in the US driven by favourable
impacts from comparator adjustments to returns and rebates, partially offset
by decreases in sales in Europe and International from continued generic
erosion by competitor products. The decline year to date reflected continued
generic erosion from competitor products in Europe and International,
partially offset by mid-single digit growth in the US, driven by favourable
impacts from comparator adjustments to returns and rebates, and the continued
use of authorised generics offsetting the removal of the AMP cap on Medicaid
drug prices.
Other General Medicines 779 (5%) -% 2,414 (6%) (1%)
Performance in Q3 2024 remained consistent with YTD performance, and continued
to be impacted by ongoing generic competition globally.
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
Q3 2024 Year to date
£m AER CER £m AER CER
US Total 4,321 (5%) (1%) 12,057 5% 9%
Excluding COVID 4,321 (5%) (1%) 12,057 5% 9%
Vaccine sales decreased in Q3 2024 and YTD primarily in Arexvy due to a more
restrictive recommendation from the from the Advisory Committee on
Immunization Practices (ACIP) for individuals aged 60 to 74, RSV vaccine
de-prioritisation in the current season due to earlier COVID-19 vaccination
and lower channel inventory versus a significant launch stocking in the
comparator quarter. Shingrix also decreased reflecting lower demand driven by
the continued challenge of activating harder-to-reach consumers. Established
Vaccines grew due to increased demand partly offset by adverse CDC stockpile
movements.
Specialty Medicines growth continued in Q3 2024 and YTD driven by Oncology and
HIV performance and continued growth in Nucala and Benlysta.
General Medicine's growth in Q3 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. Performance continues
to be impacted following the removal of the AMP cap on Medicaid drug prices,
which particularly impacted Advair, Flovent and Lamictal. This was fully
offset by the increased use of authorised generic versions of Advair and
Flovent, providing access to medicines for patients.
Europe Total 1,618 4% 6% 4,911 -% 2%
Excluding COVID 1,618 4% 6% 4,911 3% 5%
In Q3 2024, Vaccine sales growth was broadly flat driven by Bexsero
recommendation in Germany and increased Established vaccines sales partly
offset by lower Shingrix demand in Germany. YTD sales also reflected Shingrix
growth across several markets following public funding expansion.
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 strong in the quarter with mid-single digit
growth, reflecting strong performance on Trelegy and Anoro, partially offset
by declines across other general medicines. YTD performance remains broadly
stable.
International Total 2,073 2% 8% 6,291 6% 12%
Excluding COVID 2,073 2% 8% 6,290 7% 13%
In Q3 2024, sales increased 8% which reflected year-on-year exchange movements
in several International markets compared to Q3 2023.
Vaccines' strong growth in Q3 2024 and YTD was driven by Shingrix related to
the national immunisation programme in Australia and supply to our
co-promotion partner in China. Established vaccines sales declined in Q3 2024
impacted by the timing of deliveries across the region, lower demand and
competitive pressure for Synflorix and Cervarix, but grew YTD on increased
supply and higher demand for MMR/V vaccines and Boostrix.
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 strong growth in Trelegy partially offset by a decrease in other
general medicine products.
Financial performance
Total Results Q3 2024 Year to date
£m % AER % CER £m % AER % CER
Turnover 8,012 (2) 2 23,259 4 8
Cost of sales (2,397) 6 8 (6,489) 6 8
Selling, general and administration (3,800) 66 72 (8,352) 25 29
Research and development (1,459) (7) (5) (4,370) 5 7
Royalty income 168 (46) (46) 463 (36) (36)
Other operating income/(expense) (335) (1,186)
Operating profit 189 (90) (86) 3,325 (46) (41)
Net finance expense (124) (22) (19) (408) (16) (14)
Share of after tax profit/(loss) of associates (1) (3)
and joint ventures
Profit before taxation 64 (96) (92) 2,914 (49) (43)
Taxation 1 (464)
Tax rate % (1.6%) 15.9%
Profit after taxation 65 (96) (91) 2,450 (50) (45)
Profit attributable to non-controlling interests 123 289
Profit/(loss) attributable to shareholders (58) 2,161
65 (96) (91) 2,450 (50) (45)
Earnings/(loss) per share (1.4)p >(100) (100) 53.0p (53) (48)
Financial Performance - Q3 2024 results unless otherwise stated, growth % and
commentary at CER.
Core results
Reconciliations between Total results and Core results for Q3 2024, Q3 2023,
YTD 2024 and YTD 2023 are set out on pages 20, 21, 23 and 24.
Q3 2024 Year to date
£m % AER % CER £m % AER % CER
Turnover 8,012 (2) 2 23,259 4 8
Cost of sales (1,921) (7) (5) (5,531) - 1
Selling, general and administration (2,070) (5) (2) (6,272) (3) 1
Research and development (1,428) - 3 (4,202) 6 8
Royalty income 168 (46) (46) 463 (36) (36)
Core operating profit 2,761 - 5 7,717 10 16
Core profit before taxation 2,646 1 7 7,320 12 18
Taxation (461) 14 21 (1,288) 26 33
Tax rate % 17.4% 17.6%
Core profit after taxation 2,185 (1) 5 6,032 9 15
Core profit attributable to non-controlling 157 481
interests
Core profit attributable to shareholders 2,028 5,551
2,185 (1) 5 6,032 9 15
Core Earnings per share 49.7p (1) 5 136.2p 8 14
Q3 2024 Year to date
£m AER CER £m AER CER
Cost of sales Total 2,397 6% 8% 6,489 6% 8%
% of sales 29.9% 2.0% 1.5% 27.9% 0.3% (0.2%)
Core 1,921 (7%) (5%) 5,531 -% 1%
% of sales 24.0% (1.5%) (1.9%) 23.8% (1.1%) (1.5%)
Total cost of sales as a percentage of sales increased in the quarter
primarily due to additional amortisation for Zejula and Jemperli.
Core cost of sales as a percentage of sales was down in the quarter and year
to date. The quarter and year to date benefitted from price benefits from
channel mix and adjustments to returns and rebates in the US, as well as
ongoing mix benefits in higher margin Specialty Medicines products. The
quarter also benefitted from a favourable comparator to adverse inventory
provision adjustments in Q3 2023.
Q3 2024 Year to date
£m AER CER £m AER CER
Selling, general & administration Total 3,800 66% 72% 8,352 25% 29%
% of sales 47.4% 19.2% 19.1% 35.9% 5.8% 5.8%
Core 2,070 (5%) (2%) 6,272 (3%) 1%
% of sales 25.8% (1.0%) (1.0%) 27.0% (1.9%) (2.0%)
Total SG&A growth in the quarter and year to date was primarily driven by
the increase in Significant legal costs reflecting a charge of £1.8 billion
($2.3 billion) in relation to Zantac for the State Courts Settlement, the Qui
Tam Settlement, and the remaining 7% of pending state court product liability
cases, partially offset by reduced future legal costs (see details on page
38).
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 Shingrix and
investment behind long-acting HIV medicines. The quarter also benefited from a
favourable comparator to Q3 2023 due to spend phasing and investment behind
the US launch of Arexvy in 2023. 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.
Q3 2024 Year to date
£m AER CER £m AER CER
Research & Total 1,459 (7%) (5%) 4,370 5% 7%
development
% of sales 18.2% (1.1%) (1.4%) 18.8% -% (0.2%)
Core 1,428 -% 3% 4,202 6% 8%
% of sales 17.8% 0.3% -% 18.1% 0.3% -%
Total R&D growth in the year to date is driven by an increase in Core
R&D expense, partly offset by lower impairment charges compared with the
same quarter and year to date in 2023.
Year to date, Core R&D expense increased due to continued investment
across the portfolio. In Specialty Medicines, investment increased to support
late-stage clinical development programmes for camlipixant (refractory chronic
cough), the long acting TSLP asset acquired as part of the Aiolos Bio, Inc.
(Aiolos) acquisition, and bepirovirsen (chronic hepatitis B), with ongoing
strong investment in depemokimab (asthma and eosinophilic inflammation). In
Oncology, investment increased in Jemperli (endometrial cancer), and
antibody-drug-conjugates including those acquired from Hansoh Pharma at the
end of 2023. This was partly offset by cost decreases following the launches
of Arexvy and Ojjaara, and progression to completion of Zejula and Blenrep
studies. In Vaccines, clinical trial programmes associated with the
pneumococcal Multi Antigen Presenting System (MAPS) and mRNA continued to
drive investment. HIV investment increased on next-generation long-acting
treatment and preventative medicines.
These were also the main drivers of Core R&D expense growth in the
quarter.
Q3 2024 Year to date
£m AER CER £m AER CER
Royalty income Total 168 (46%) (46%) 463 (36%) (36%)
Core 168 (46%) (46%) 463 (36%) (36%)
The decrease in Total and Core royalty income in Q3 2024 and year to date
primarily reflected the cessation of the majority of Gardasil royalties at the
end of 2023, with Q3 2024 Gardasil royalties of £8 million (Q3 2023: £189
million). This was partly offset by increases in Kesimpta and Biktarvy
royalties.
Q3 2024 Year to date
£m AER CER £m AER CER
Other operating Total (335) 9% 9% (1,186) >(100%) >(100%)
income/(expense)
In Q3 2024 the other operating expense reflected a charge of £359 million (Q3
2023: £576 million) principally arising from the remeasurement of contingent
consideration liabilities (CCL) primarily reflecting improved longer term HIV
prospects partly offset by favourable foreign currency movements, an increase
in liability for the Vaccines CCL, and the remeasurement of the Pfizer, Inc.
(Pfizer) put option. In the quarter, there were no fair value movements
recorded for Haleon plc (Haleon) shares (Q3 2023: £184 million gain)
following the sale of the remaining shares in May 2024. Other net income was
comparable to the same period last year at £24 million (Q3 2023: £25
million).
The year to date other operating expense reflected a charge of £1,422 million
(YTD 2023: £116 million) principally arising from the remeasurement of CCLs
primarily reflecting improved longer term HIV prospects partly offset by
favourable foreign currency movements, an increase in liability for the
Vaccines CCL, and remeasurement of the Pfizer put option. This was partly
offset by a fair value gain of £22 million (YTD 2023: £154 million gain) on
the retained stake in Haleon, as well as higher other net income of £214
million (YTD 2023: £170 million).
Q3 2024 Year to date
£m AER CER £m AER CER
Operating profit Total 189 (90%) (86%) 3,325 (46%) (41%)
% of sales 2.4% (21.6%) (20.6%) 14.3% (13.4%) (12.5%)
Core 2,761 -% 5% 7,717 10% 16%
% of sales 34.5% 0.4% 1.0% 33.2% 1.6% 2.2%
Total operating profit margin was lower in Q3 2024 and year to date primarily
due to a charge of £1.8 billion ($2.3 billion) for the Zantac settlement (see
details on page 38), additional amortisation for Zejula and Jemperli, and no
fair value movements on Haleon shares (Q3 2023 and year to date fair value
gain). This was partly offset by lower charges in the quarter in the ViiV
Healthcare CCL reflecting favourable foreign currency movements offset by
improved longer term HIV prospects. In the year to date higher CCL charges
were driven by improved longer term HIV prospects and other remeasurements,
partly offset by favourable foreign currency movements.
Core operating profit in the quarter and year to date benefitted from strong
Specialty Medicines sales performance, with 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 had minimal impact in the quarter on Core
operating profit growth and three percentage points year to date, with minimal
impact on Core operating profit margin.
Q3 2024 Year to date
£m AER CER £m AER CER
Net finance expense Total 124 (22%) (19%) 408 (16%) (14%)
Core 114 (27%) (24%) 394 (18%) (16%)
The decrease in net finance costs in Q3 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.
Q3 2024 Year to date
£m AER CER £m AER CER
Taxation Total (1) >(100%) (95%) 464 (40%) (33%)
Tax rate % (1.6%) 15.9%
Core 461 14% 21% 1,288 26% 33%
Tax rate % 17.4% 17.6%
The effective tax rate on Total results reflected the different tax effects of
the various Adjusting items included in Total results, including the impact of
the Zantac settlement.
The effective tax rate on Core profits is broadly in line with expectations
for the year and included 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.
Q3 2024 Year to date
£m AER CER £m AER CER
Non-controlling Total 123 76% 84% 289 (13%) (5%)
interests ("NCIs")
Core 157 (7%) (5%) 481 15% 20%
The increase in Total profit after taxation allocated to NCIs in the quarter
was primarily driven by higher ViiV Healthcare profits (including a lower
remeasurement loss on the CCL), partly offset by lower net profits in some of
the Group's other entities. The decrease in the year to date Total profit
after taxation allocated to NCIs was driven by lower ViiV Healthcare Total
profits (including a higher remeasurement loss on the CCL) with an allocation
of £270 million (YTD 2023: £324 million), partly offset by higher net
profits in some of the Group's other entities.
The decrease in Core profit after taxation allocated to NCIs in Q3 2024
primarily reflected lower net profits in some of the Group's other entities
with NCIs. The increase in the year to date Core profit after taxation
allocated to NCIs reflected higher core profit allocations from ViiV
Healthcare, with £462 million in the year to date (YTD 2023: £412 million),
as well as higher net profits in some of the Group's other entities with NCIs.
Q3 2024 Year to date
£p AER CER £p AER CER
Earnings/(loss) per share Total (1.4p) >(100%) (100%) 53.0p (53%) (48%)
Core 49.7p (1%) 5% 136.2p 8% 14%
The decrease in the Q3 2024 and year to date Total EPS is primarily due to a
charge of £1.8 billion ($2.3 billion) for the Zantac settlement (see details
on page 38).
The increase in the Core EPS in the quarter primarily reflected the growth in
Core operating profit as well as lower finance costs and lower non-controlling
interests, partly offset by a higher effective taxation rate. The increase in
the year to date Core EPS is driven by the growth in Core operating profit and
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 three percentage points in the year to date.
Currency impact on results
The results for Q3 2024 are based on average exchange rates, principally
$1.31/£1, €1.19/£1 and Yen192/£1. The period-end exchange rates were
$1.34/£1, €1.20/£1 and Yen 191/£1. Comparative exchange rates are given
on page 40.
Q3 2024 Year to date
£m/£p AER CER £m/£p AER CER
Turnover 8,012 (2%) 2% 23,259 4% 8%
Earnings/(loss) per share Total (1.4p) >(100%) (100%) 53.0p (53%) (48%)
Core 49.7p (1%) 5% 136.2p 8% 14%
In Q3 2024 and 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
Q3 2024 Q3 2023 9 months 2024 9 months 2023
£m £m £m £m
Cash generated from operations (£m) 2,499 2,508 5,275 4,415
Net cash generated from operating activities (£m) 2,154 2,212 4,225 3,572
Free cash inflow/(outflow)* (£m) 1,322 1,655 1,939 1,314
Free cash flow growth (%) (20%) >100% 48% (41%)
Free cash flow conversion* (%) >100% >100% 90% 29%
Total net debt** (£m) 12,847 17,589 12,847 17,589
* Free cash flow and free cash flow conversion are defined on page 52. Free cash
flow is analysed on page 43.
** Net debt is analysed on page 43.
Q3 2024
Cash generated from operations for the quarter was £2,499 million (Q3 2023:
£2,508 million). The slight decrease primarily reflected the timing of
returns and rebates, including the impact of the removal of the AMP cap, and
various adverse movements in other payables, including the phasing of trade
payables. These were largely offset by higher trade receivables in Q3 2023 due
to the outstanding 2023 launch of Arexvy in the US.
Total contingent consideration cash payments in the quarter were £309 million
(Q3 2023: £281 million), including cash payments made to Shionogi & Co.
Ltd (Shionogi) of £295 million (Q3 2023: £269 million). £305 million (Q3
2023: £278 million) of these were recognised in cash flows from operating
activities.
Free cash inflow was £1,322 million for the quarter (Q3 2023:
£1,655 million). The decrease is driven by higher capital expenditure on
intangible assets including the £342 million upfront payment to CureVac N.V
(CureVac), higher tax payments and higher dividends paid to non-controlling
interests, partly offset by higher proceeds from the sale of intangible
assets.
9 months 2024
Cash generated from operating activities was £5,275 million (9 months 2023:
£4,415 million). The increase primarily reflected higher Core operating
profit, higher receivables' collections, particularly for Arexvy, 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 9 months 2024 were
£935 million (9 months 2023: £860 million), including cash payments made
to Shionogi of £900 million (9 months 2023: £834 million). £924 million
(9 months 2023: £853 million) of these were recognised in cash flows from
operating activities.
Free cash inflow was £1,939 million for 9 months 2024 (9 months 2023: £1,314
million). The increase was primarily driven by the increase in cash generated
from operating activities, as well as higher proceeds from the sale of
intangible assets as well as lower net interest paid and lower dividends paid
to non-controlling interests. These were partly offset by higher capital
expenditure on intangible assets including the £342 million upfront payment
to CureVac, and higher tax payments.
Total Net debt
At 30 September 2024, net debt was £12,847 million, compared with £15,040
million at 31 December 2023, comprising gross debt of £16,059 million and
cash and liquid investments of £3,212 million. See net debt information on
page 42 and 43.
Net debt decreased by £2,193 million primarily due to £1,939 million free
cash inflow and £2,354 million proceeds from the disposal of investments,
primarily the sale of the remaining retained stake in Haleon, and exchange on
net debt of £504 million. This was partly offset by the net acquisition costs
of Aiolos and Elsie Biotechnologies for £748 million, and dividends paid to
shareholders of £1,832 million.
At 30 September 2024, GSK had short-term borrowings (including overdrafts and
lease liabilities) repayable within 12 months of £2,815 million and £1,417
million repayable in the subsequent year.
Page
Q3 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 39
Additional information 40
Net debt information 42
Post balance sheet event 43
Related party transactions 43
R&D commentary 44
Reporting definitions 52
Guidance and outlooks, assumptions and cautionary statements 54
Independent Auditor's review report to GSK plc 55
Contacts
GSK plc (LSE/NYSE:GSK) is a global biopharma company with a purpose to unite
science, technology, and talent to get ahead of disease together. Find out
more at www.gsk.com (http://www.gsk.com/) .
GSK enquiries:
Media Tim Foley +44 (0) 20 8047 5502 (London)
Kathleen Quinn +1 202 603 5003 (Washington)
Investor Relations Annabel Brownrigg-Gleeson +44 (0) 7901 101944 (London)
James Dodwell +44 (0) 7881 269066 (London)
Mick Readey +44 (0) 7990 339653 (London)
Jeff McLaughlin +1 215 589 3774 (Philadelphia)
Registered in England & Wales:
No. 3888792
Registered Office:
79 New Oxford Street
London,
WC1A 1DG.
Q3 2024 pipeline highlights (since 31 July 2024)
Medicine/vaccine Trial (indication, presentation) Event
Regulatory approvals or other regulatory actions Arexvy RSV, adults aged 50-59 years at increased risk Regulatory approval (EU)
Bexsero Meningitis B Regulatory full approval (US)
Menveo Liquid formulation, meningitis ACWY Positive CHMP opinion (EU)
Nucala Chronic rhinosinusitis with nasal polyps Regulatory approval (JP)
Jemperli RUBY part 1 (OS overall population, 1L endometrial cancer) Regulatory approval (US)
Regulatory submissions or acceptances gepotidacin EAGLE-2/3 (uncomplicated urinary tract infection) Regulatory submission accepted (US) with Priority Review
Blenrep DREAMM-7/8 (2L+ multiple myeloma) Regulatory submission accepted (JP) with Orphan Drug designation and Priority
Review
Phase III data readouts or other significant events Arexvy RSV, adults aged 60 years and older Positive phase III data readout (season three)
Arexvy RSV, adults aged 18-49 years at increased risk; immunocompromised adults aged Positive phase IIIb, IIb data readout
18+
Seasonal influenza vaccine mRNA candidate Seasonal influenza, older and younger adults Positive phase II data readout
depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps) Positive phase III data readout
Nucala MATINEE (chronic obstructive pulmonary disease) Positive phase III data readout
Regulatory designations and other significant events bepirovirsen B-Clear; B-Sure (chronic hepatitis B) SENKU designation granted (JP)
Blenrep DREAMM-7 (2L+ multiple myeloma) Breakthrough Therapy Designation and Priority Review granted (CN)
GSK5764227 (B7-H3-targeted antibody-drug conjugate) Extensive-stage small-cell lung cancer Breakthrough Therapy Designation granted (US)
Anticipated news flow
Timing Medicine/vaccine Trial (indication, presentation) Event
H2 2024 Arexvy RSV, adults aged 50-59 years at increased risk Regulatory decision (JP)
Menveo Liquid formulation, meningitis ACWY Regulatory decision (EU)
depemokimab SWIFT-1/2 (severe asthma) Regulatory submission (US)
depemokimab ANCHOR-1/2 (chronic rhinosinusitis with nasal polyps) Regulatory submission (US)
Nucala MATINEE (chronic obstructive pulmonary disease) Regulatory submission (US)
Blenrep DREAMM-7/8 (2L + multiple myeloma) Regulatory file acceptance (US)
Blenrep DREAMM-7 (2L + multiple myeloma) Regulatory submission (CN)
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 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)
depemokimab AGILE (severe asthma) Phase III data readout
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
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 NIMBLE (asthma) Phase III data readout
Ventolin Low carbon MDI (asthma) Regulatory submission (EU)
Blenrep DREAMM-7/8 (2L+ multiple myeloma) Regulatory decision
(US, EU)
Blenrep DREAMM-8 (2L + multiple myeloma) Regulatory submission (CN)
cobolimab COSTAR, (2L non-small cell lung cancer) Regulatory submission
(US, EU)
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 44 to 51 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 Q2 2024 results. For more details on annual updates, please see
GSK's ESG Performance Report 2023
(https://www.gsk.com/media/11009/esg-performance-report-2023.pdf) (1).
Access
Commitment: to make GSK's vaccines and medicines available at value-based
prices that are sustainable for the business and implement access strategies
that increase the use of GSK's vaccines and medicines to treat and protect
underserved people.
Progress since Q2 2024:
• In October ViiV Healthcare announced a commitment to make at least two million
doses of CAB LA for PrEP available for procurement in low-and middle-income
countries during 2025-2026. This new commitment triples the available supply
versus 2024 to accelerate access and meet growing demand where the HIV burden
and unmet need are the greatest.
• ViiV Healthcare continues to progress the rollout of the first long-acting
injectable for HIV pre-exposure prophylaxis (CAB LA for PrEP) at record pace
in Sub-Saharan Africa (SSA) and lower income countries. In Q3 2024, ViiV
started roll-out to 2 additional countries - eSwatini and Ukraine - with our
global partner The United States President's Emergency Plan for AIDS Relief
(PEPFAR) programme. Rollout of CAB LA for PrEP in low-income and SSA countries
at a not-for-profit price began in Zambia in February 2024, just two years
after the U.S. FDA approval and is currently supplied to key partners in 5
countries.
• In September, GSK donated
(https://unitingtocombatntds.org/en/news-and-views/zanzibar-marks-historic-milestone-with-12-billionth-medicine-dose-in-fight-against-ntds)
(2) the 12 billionth tablet of Albendazole which will help in the eradication
of lymphatic filariasis (LF) and treatment of soil transmitted helminths
(STH). Since 2000, GSK has been committed to change the trajectory of NTDs by
eliminating LF as a public health issue worldwide. At the end of September,
Brazil became the 20th country to eliminate LF as a public health problem. GSK
contributed to this through support for diagnosis and transmission assessment
surveys.
• Performance metrics related to access are updated annually with related
details in GSK's ESG Performance Report 2023
(https://www.gsk.com/media/11009/esg-performance-report-2023.pdf) (1) 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 Q2 2024:
• In September it was announced that GSK will commit €4.5m over three years to
Global Antibiotic Research and Development partnership (Gard-P), to ensure
equitable access to antibiotics in lower-income countries. This funding aims
to tackle the challenges that hinder critical antibiotics from reaching those
in need. More information can be found here
(https://gardp.org/funders-invest-an-unprecedented-eur-60-million-in-innovative-antibiotic-rd-and-access-partnership/#:~:text=GSK,%20a%20leading%20global%20biopharma%20company)
(3).
• In September, TRIC-TB, the European Union's IMI2 programme for developing new
treatments for infectious diseases, successfully delivered a Phase 2-ready
tuberculosis clinical candidate, alpibectir, that is being jointly developed
by BioVersys and GSK. More information can be found here
(https://www.bioversys.com/nature-reviews-highlights-significant-successes-of-antibiotic-collaboration-and-calls-for-sustainable-rd-funding-schemes/)
(4).
• 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 Q2 2024:
• GSK's Worthing manufacturing facility has become the first
(https://www.bsigroup.com/en-GB/insights-and-media/media-centre/press-releases/2024/september/gsk-site-announced-as-first-in-the-uk-to-achieve-bsi-amr-kitemark-certification-showcasing-responsible-approach-to-antibiotic-manufacturing/?utm_source=linkedin&utm_medium=organic&utm_campaign=UNGA24&utm_content=UNGA24_BSI&linkId=100000290447004)
(5) in the UK to achieve BSI Kitemark Certification for Minimised Risk of
Antimicrobial Resistance. Achieving this rigorous international certification
demonstrates GSK's commitment to the responsible manufacturing of antibiotics
and ambition to ensure all global antibiotic manufacturing sites are certified
by the end of 2026.
• The Energize programme, which was co-founded by GSK and supports suppliers to
access renewable energy, announced its first deal which includes four of GSK's
suppliers in Europe and will support seven new solar energy projects in Spain,
as well as bringing additional renewable capacity to the European grid. This
marks an important step in our plan to reduce our value chain emissions by 80%
from 2020 to 2030.
• 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.
More information on DEI at GSK can be found here
(https://www.gsk.com/en-gb/responsibility/diversity-equity-and-inclusion/)
(6).
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 78 80 Current score updated September 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 bi-annual 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 October 2024
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
(https://www.gsk.com/media/11009/esg-performance-report-2023.pdf)
(2) https://unitingtocombatntds.org/en/news-and-views/zanzibar-marks-historic-milestone-with-12-billionth-medicine-dose-in-fight-against-ntds
(https://unitingtocombatntds.org/en/news-and-views/zanzibar-marks-historic-milestone-with-12-billionth-medicine-dose-in-fight-against-ntds/#:~:text=September%2019,%202024%20%E2%80%94%20Mzambarauni%20Village)
(3) https://gardp.org/funders-invest-an-unprecedented-eur-60-million-in-innovative-antibiotic-rd-and-access-partnership
(https://gardp.org/funders-invest-an-unprecedented-eur-60-million-in-innovative-antibiotic-rd-and-access-partnership/#:~:text=GSK,%20a%20leading%20global%20biopharma%20company)
(4) https://www.bioversys.com/nature-reviews-highlights-significant-successes-of-antibiotic-collaboration-and-calls-for-sustainable-rd-funding-schemes/
(https://www.bioversys.com/nature-reviews-highlights-significant-successes-of-antibiotic-collaboration-and-calls-for-sustainable-rd-funding-schemes/)
(5) https://www.bsigroup.com/en-GB/insights-and-media/media-centre/press-releases/2024/september/gsk-site-announced-as-first-in-the-uk-to-achieve-bsi-amr-kitemark-certification-showcasing-responsible-approach-to-antibiotic-manufacturing
(https://www.bsigroup.com/en-GB/insights-and-media/media-centre/press-releases/2024/september/gsk-site-announced-as-first-in-the-uk-to-achieve-bsi-amr-kitemark-certification-showcasing-responsible-approach-to-antibiotic-manufacturing/?utm_source=linkedin&utm_medium=organic&utm_campaign=UNGA24&utm_content=UNGA24_BSI&linkId=100000290447004)
(6) https://www.gsk.com/en-gb/responsibility/diversity-equity-and-inclusion/
(https://www.gsk.com/en-gb/responsibility/diversity-equity-and-inclusion/)
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 was 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 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 52.
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 nine
months ended 30 September 2024 were £900 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 Q3 2024 and Q3
2023 are set out below.
Three months ended 30 September 2024
Total Intangible Intangible Major Trans- Significant Core
results amort- impair- restruct- action- legal, Divest- results
£m isation ment uring related ments and £m
£m £m £m £m other
items
£m
Turnover 8,012 8,012
Cost of sales (2,397) 402 67 2 5 (1,921)
Gross profit 5,615 402 67 2 5 6,091
Selling, general and administration (3,800) 33 1,697 (2,070)
Research and development (1,459) 13 17 1 (1,428)
Royalty income 168 168
Other operating income/(expense) (335) (1) 359 (23) -
Operating profit 189 415 17 100 361 1,679 2,761
Net finance expense (124) 1 9 (114)
Share of after tax profit/(loss) of associates (1) (1)
and joint ventures
Profit before taxation 64 415 17 101 361 1,688 2,646
Taxation 1 (88) (3) (22) (103) (246) (461)
Tax rate % (1.6%) 17.4%
Profit after taxation 65 327 14 79 258 1,442 2,185
Profit attributable to non-controlling 123 34 157
interests
Profit/(loss) attributable to shareholders (58) 327 14 79 224 1,442 2,028
65 327 14 79 258 1,442 2,185
Earnings/(loss) per share (1.4)p 8.0p 0.3p 1.9p 5.5p 35.4p 49.7p
Weighted average number of shares (millions) 4,080 4,080
Three months ended 30 September 2023
Total Intangible Intangible Major Trans- Significant Core
results amort- impair- restruct- action- legal, Divest- results
£m isation ment uring related ments and £m
£m £m £m £m other
items
£m
Turnover 8,147 8,147
Cost of sales (2,272) 162 29 8 (2,073)
Gross profit 5,875 162 29 8 6,074
Selling, general and administration (2,296) 83 1 27 (2,185)
Research and development (1,575) 20 129 (2) (1) (1,429)
Royalty income 312 312
Other operating income/(expense) (367) 576 (209) -
Operating profit 1,949 182 129 110 577 (175) 2,772
Net finance expense (158) 2 (156)
Profit before taxation 1,791 182 129 110 577 (173) 2,616
Taxation (257) (40) (30) (19) (61) 3 (404)
Tax rate % 14.3% 15.4%
Profit after taxation 1,534 142 99 91 516 (170) 2,212
Profit attributable to non-controlling 70 99 169
interests
Profit attributable to shareholders 1,464 142 99 91 417 (170) 2,043
1,534 142 99 91 516 (170) 2,212
Earnings per share 36.1p 3.5p 2.4p 2.2p 10.3p (4.1)p 50.4p
Weighted average number of shares (millions) 4,055 4,055
Adjusting items Q3 2024
Major restructuring and integration
Total Major restructuring charges incurred in Q3 2024 were £100 million (Q3
2023: £110 million), analysed as follows:
Q3 2024 Q3 2023
Cash Non- Total Cash Non- Total
£m cash £m £m cash £m
£m £m
Separation restructuring programme 42 (2) 40 45 50 95
Significant acquisitions 15 - 15 18 (1) 17
Legacy programmes 45 - 45 (1) (1) (2)
102 (2) 100 62 48 110
The Separation restructuring programme incurred cash charges of £42 million
primarily from restructuring of some commercial and administrative functions
as well as Global Supply Chain. The non-cash credit of £2 million primarily
reflected an adjustment to 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.
Cash charges of £45 million under Legacy programmes primarily arose from the
divestment of the cephalosporins business.
Transaction-related adjustments
Transaction-related adjustments resulted in a net charge of £361 million (Q3
2023: £577 million), the majority of which related to charges/(credits) for
the remeasurement of contingent consideration liabilities, the liabilities for
the Pfizer put option, and Pfizer and Shionogi preferential dividends in ViiV
Healthcare.
Charge/(credit) Q3 2024 Q3 2023
£m £m
Contingent consideration on former Shionogi-ViiV Healthcare joint Venture 292 479
(including Shionogi preferential dividends)
ViiV Healthcare put options and Pfizer preferential dividends (16) 40
Contingent consideration on former Novartis Vaccines business 46 (12)
Contingent consideration on acquisition of Affinivax 15 69
Other adjustments 24 1
Total transaction-related charges 361 577
The £292 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 £185 million
driven by updated sales forecasts partly offset by exchange rates, and the
unwind of the discount for £107 million. The £16 million credit relating to
the ViiV Healthcare put option and Pfizer preferential dividends represented
updated exchange rates and higher preference dividends, partly offset by 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 £46 million charge relating to the contingent consideration on the former
Novartis Vaccines business primarily related to changes to future sales
forecasts.
The £15 million charge relating to the contingent consideration on the
acquisition of Affinivax primarily related to the unwind of the discount.
Significant legal charges, Divestments, and other items
Significant legal charges in the quarter primarily reflected a charge of £1.8
billion ($2.3 billion) in relation to Zantac for the State Courts Settlement,
the Qui Tam Settlement, and the remaining 7% of pending state court product
liability cases, partially offset by reduced future legal costs.
Legal charges provide for all significant legal matters and are not broken out
separately by litigation or investigation.
Divestments and other items included other net income of £23 million, which
includes milestones and royalty income.
The reconciliations between Total results and Core results for 9 months 2024
and 9 months 2023 are set out below.
Nine months ended 30 September 2024
Total Intangible Intangible Major Trans- Significant Core
results amort- impair- restruct- action- legal, Divest- results
£m isation ment uring related ments and £m
£m £m £m £m other
items
£m
Turnover 23,259 23,259
Cost of sales (6,489) 764 141 40 13 (5,531)
Gross profit 16,770 764 141 40 13 17,728
Selling, general and administration (8,352) 125 1 1,954 (6,272)
Research and development (4,370) 40 118 10 (4,202)
Royalty income 463 463
Other operating income/(expense) (1,186) 5 1,422 (241) -
Operating profit 3,325 804 118 281 1,463 1,726 7,717
Net finance expense (408) 1 13 (394)
Share of after tax profit/(loss) of associates (3) (3)
and joint venture
Profit before taxation 2,914 804 118 282 1,463 1,739 7,320
Taxation (464) (172) (28) (69) (300) (255) (1,288)
Tax rate % 15.9% 17.6%
Profit after taxation 2,450 632 90 213 1,163 1,484 6,032
Profit attributable to non-controlling 289 192 481
interests
Profit attributable to shareholders 2,161 632 90 213 971 1,484 5,551
2,450 632 90 213 1,163 1,484 6,032
Earnings per share 53.0p 15.5p 2.2p 5.2p 23.8p 36.5p 136.2p
Weighted average number of shares (millions) 4,076 4,076
Nine months ended 30 September 2023
Total Intangible Intangible Major Trans- Significant Core
results amort- impair- restruct- action- legal, results
£m isation ment uring related Divest- £m
£m £m £m £m ments and
other
items
£m
Turnover 22,276 22,276
Cost of sales (6,147) 477 97 20 (5,553)
Gross profit 16,129 477 97 20 16,723
Selling, general and administration (6,707) 163 1 102 (6,441)
Research and development (4,176) 58 149 4 (1) (3,966)
Royalty income 718 718
Other operating income/(expense) 208 116 (324) -
Operating profit 6,172 535 149 264 117 (203) 7,034
Net finance expense (484) 1 5 (478)
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 5,685 535 149 265 117 (199) 6,552
Taxation (775) (116) (35) (52) (29) (15) (1,022)
Tax rate % 13.6% 15.6%
Profit after taxation 4,910 419 114 213 88 (214) 5,530
Profit attributable to non-controlling 332 88 420
interests
Profit attributable to shareholders 4,578 419 114 213 - (214) 5,110
4,910 419 114 213 88 (214) 5,530
Earnings per share 113.0p 10.3p 2.8p 5.3p - (5.2)p 126.2p
Weighted average number of shares (millions) 4,050 4,050
Adjusting items year to date 2024
Major restructuring and integration
Total Major restructuring charges incurred in nine months ended 30 September
2024 were £281 million (nine months ended 30 September 2023: £264 million),
analysed as follows:
9 months 2024 9 months 2023
Cash Non- Total Cash Non- Total
£m cash £m £m cash £m
£m £m
Separation restructuring programme 169 14 183 107 101 208
Significant acquisitions 50 1 51 54 1 55
Legacy programmes 47 - 47 1 - 1
266 15 281 162 102 264
The Separation restructuring programme incurred cash charges of £169 million
primarily from the restructuring of some commercial and administrative
functions as well as Supply Chain. The non-cash charges of £14 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 and
Affinivax which were acquired in Q3 2022, Bellus acquired in Q2 2023 and
Aiolos acquired in Q1 2024.
Cash charges of £47 million under Legacy programmes primarily arose from the
divestment of the cephalosporins business.
Transaction-related adjustments
Transaction-related adjustments resulted in a net charge of £1,463 million
(YTD 2023: £117 million net charge), 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) 9 months 2024 9 months 2023
£m £m
Contingent consideration on former Shionogi-ViiV Healthcare joint Venture 1,106 406
(including Shionogi preferential dividends)
ViiV Healthcare put options and Pfizer preferential dividends 54 (203)
Contingent consideration on former Novartis Vaccines business 206 (134)
Contingent consideration on acquisition of Affinivax 31 47
Other adjustments 66 1
Total transaction-related charges 1,463 117
The £1,106 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 £789
million from updated future sales forecasts and exchange rates, and the unwind
of the discount for £317 million. The £54 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 £206 million charge relating to the contingent consideration on the
former Novartis Vaccines business primarily related to changes to future sales
forecasts.
The £31 million charge relating to the contingent consideration on the
acquisition of Affinivax primarily related to the unwind of the discount.
Significant legal charges, Divestments, and other items
Significant legal charges in the year to date primarily reflected the Q3 2024
charge of £1.8 billion ($2.3 billion) in relation to Zantac for the State
Courts Settlement, the Qui Tam Settlement, and the remaining 7% of pending
state court product liability cases, partially offset by reduced future legal
costs.
Legal charges provide for all significant legal matters and are not broken out
separately by litigation or investigation.
Divestments and other items primarily included £241 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.
Financial information
Income statement
Q3 2024 Q3 2023 9 months 2024 9 months 2023
£m £m £m £m
TURNOVER 8,012 8,147 23,259 22,276
Cost of sales (2,397) (2,272) (6,489) (6,147)
Gross profit 5,615 5,875 16,770 16,129
Selling, general and administration (3,800) (2,296) (8,352) (6,707)
Research and development (1,459) (1,575) (4,370) (4,176)
Royalty income 168 312 463 718
Other operating income/(expense) (335) (367) (1,186) 208
OPERATING PROFIT 189 1,949 3,325 6,172
Finance income 32 24 88 86
Finance expense (156) (182) (496) (570)
Share of after tax profit/(loss) of associates and joint ventures (1) - (3) (4)
Profit/(loss) on disposal of interests in associates and joint - - - 1
ventures
PROFIT BEFORE TAXATION 64 1,791 2,914 5,685
Taxation 1 (257) (464) (775)
Tax rate % (1.6%) 14.3% 15.9% 13.6%
PROFIT AFTER TAXATION 65 1,534 2,450 4,910
Profit attributable to non-controlling interests 123 70 289 332
Profit/(loss) attributable to shareholders (58) 1,464 2,161 4,578
65 1,534 2,450 4,910
EARNINGS/(LOSS) PER SHARE (1.4)p 36.1p 53.0p 113.0p
Diluted earnings/(loss) per share (1.4)p 35.6p 52.2p 111.4p
Statement of comprehensive income
Q3 2024 Q3 2023 9 months 2024 9 months 2023
£m £m £m £m
Total profit for the period 65 1,534 2,450 4,910
Items that may be reclassified subsequently to income statement:
Exchange movements on overseas net assets and net 164 (94) (47) (87)
investment hedges
Reclassification of exchange movements on liquidation or (57) (7) (56) (20)
disposal of overseas subsidiaries and associates
Fair value movements on cash flow hedges (1) - (1) 1
Cost of hedging (5) - (5) -
Deferred tax on fair value movements on cash flow hedges (1) - (1) (1)
Reclassification of cash flow hedges to income statement 2 1 4 4
102 (100) (106) (103)
Items that will not be reclassified to income statement:
Exchange movements on overseas net assets of (24) 5 (17) (17)
non-controlling interests
Fair value movements on equity investments (27) (242) (108) (359)
Tax on fair value movements on equity investments 3 18 6 35
Fair value movements on cash flow hedges 3 - 2 (34)
Remeasurement gains/(losses) on defined benefit plans 192 (266) 373 (216)
Tax on remeasurement losses/(gains) on defined benefit (45) 63 (87) 55
plans
102 (422) 169 (536)
Other comprehensive income/(expense) for the period 204 (522) 63 (639)
Total comprehensive income for the period 269 1,012 2,513 4,271
Total comprehensive income for the period attributable to:
Shareholders 170 937 2,241 3,956
Non-controlling interests 99 75 272 315
269 1,012 2,513 4,271
Balance sheet
30 September 2024 31 December 2023
£m £m
ASSETS
Non-current assets
Property, plant and equipment 8,885 9,020
Right of use assets 840 937
Goodwill 6,680 6,811
Other intangible assets 15,010 14,768
Investments in associates and joint ventures 81 55
Other investments 1,023 1,137
Deferred tax assets 6,288 6,049
Derivative instruments 4 -
Other non-current assets 1,940 1,584
Total non-current assets 40,751 40,361
Current assets
Inventories 5,918 5,498
Current tax recoverable 484 373
Trade and other receivables 7,383 7,385
Derivative financial instruments 241 130
Current equity investments - 2,204
Liquid investments 20 42
Cash and cash equivalents 3,192 2,936
Assets held for sale 60 76
Total current assets 17,298 18,644
TOTAL ASSETS 58,049 59,005
LIABILITIES
Current liabilities
Short-term borrowings (2,815) (2,813)
Contingent consideration liabilities (1,105) (1,053)
Trade and other payables (14,375) (15,844)
Derivative financial instruments (146) (114)
Current tax payable (568) (500)
Short-term provisions (2,450) (744)
Total current liabilities (21,459) (21,068)
Non-current liabilities
Long-term borrowings (13,244) (15,205)
Corporation tax payable (19) (75)
Deferred tax liabilities (294) (311)
Pensions and other post-employment benefits (2,028) (2,340)
Other provisions (492) (495)
Contingent consideration liabilities (6,020) (5,609)
Other non-current liabilities (1,040) (1,107)
Total non-current liabilities (23,137) (25,142)
TOTAL LIABILITIES (44,596) (46,210)
NET ASSETS 13,453 12,795
EQUITY
Share capital 1,348 1,348
Share premium account 3,473 3,451
Retained earnings 8,187 7,239
Other reserves 1,000 1,309
Shareholders' equity 14,008 13,347
Non-controlling interests (555) (552)
TOTAL EQUITY 13,453 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 2,161 2,161 289 2,450
Other comprehensive 146 (66) 80 (17) 63
income/(expense) for the period
Total comprehensive income/(expense) 2,307 (66) 2,241 272 2,513
for the period
Distributions to non-controlling interests (288) (288)
Dividends to shareholders (1,832) (1,832) (1,832)
Realised after tax losses on disposal 15 (15) -
or liquidation of equity investments
Share of associates and joint ventures 52 (52) -
realised profit/(loss) on disposal of
equity investments
Shares issued 20 20 20
Write-down on shares held by ESOP Trusts (283) 283 -
Shares acquired by ESOP Trusts 2 457 (459) -
Share-based incentive plans 232 232 232
Contributions from non-controlling interests 9 9
Changes to non-controlling interests - 4 4
At 30 September 2024 1,348 3,473 8,187 1,000 14,008 (555) 13,453
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 4,578 - 4,578 332 4,910
Other comprehensive (279) (343) (622) (17) (639)
income/(expense) for the period
Total comprehensive income/(expense) 4,299 (343) 3,956 315 4,271
for the period
Distributions to non-controlling interests (334) (334)
Contributions from non-controlling 7 7
interests
Dividends to shareholders (1,679) (1,679) (1,679)
Realised after tax losses on disposal or (33) 33 -
liquidation of equity investments
Share of associates and joint ventures 2 (2) -
realised profit/(loss) on disposal of
equity investments
Share issued 1 8 9 9
Write-down of shares held by ESOP Trusts (153) 153 -
Shares acquired by ESOP Trusts 2 1 (3) -
Share-based incentive plans 217 217 217
Hedging gain/(loss) after taxation 32 32 32
transferred to non-financial assets
At 30 September 2023 1,348 3,450 7,017 1,318 13,133 (514) 12,619
Cash flow statement nine months ended 30 September 2024
9 months 2024 9 months 2023
£m £m
Profit after tax 2,450 4,910
Tax on profits 464 775
Share of after tax loss/(profit) of associates and joint ventures 3 4
(Profit)/loss on disposal of interest in associates and joint ventures - (1)
Net finance expense 408 484
Depreciation, amortisation and other adjusting items 2,139 1,671
(Increase)/decrease in working capital (1,669) (2,669)
Contingent consideration paid (924) (853)
Increase/(decrease) in other net liabilities (excluding contingent 2,404 94
consideration paid)
Cash generated from operations 5,275 4,415
Taxation paid (1,050) (843)
Total net cash inflow/(outflow) from operating activities 4,225 3,572
Cash flow from investing activities
Purchase of property, plant and equipment (855) (828)
Proceeds from sale of property, plant and equipment 4 21
Purchase of intangible assets (992) (733)
Proceeds from sale of intangible assets 126 12
Purchase of equity investments (76) (92)
Proceeds from sale of equity investments 2,354 834
Purchase of businesses, net of cash acquired (748) (1,459)
Investment in joint ventures and associates (42) -
Contingent consideration paid (11) (7)
Disposal of businesses (13) 56
Interest received 91 83
(Increase)/decrease in liquid investments 21 47
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 (110) (1,863)
Cash flow from financing activities
Issue of share capital 20 9
Repayment of long-term loans - (144)
Issue of long-term notes - 238
Repayment of short-term loans (787) (1,088)
Net increase/(repayment) of other short-term loans (623) 1,394
Repayment of lease liabilities (170) (148)
Interest paid (385) (480)
Dividends paid to shareholders (1,832) (1,679)
Distribution to non-controlling interests (288) (334)
Contributions from non-controlling interests 9 7
Other financing items 172 176
Total net cash inflow/(outflow) from financing activities (3,884) (2,049)
Increase/(decrease) in cash and bank overdrafts in the period 231 (340)
Cash and bank overdrafts at beginning of the period 2,858 3,425
Exchange adjustments (61) (65)
Increase/(decrease) in cash and bank overdrafts 231 (340)
Cash and bank overdrafts at end of the period 3,028 3,020
Cash and bank overdrafts at end of the period comprise:
Cash and cash equivalents 3,192 3,177
Overdrafts (164) (157)
3,028 3,020
Sales tables
Vaccines turnover - three months ended 30 September 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Shingles 739 (10) (7) 307 (26) (23) 194 (15) (13) 238 29 35
Shingrix 739 (10) (7) 307 (26) (23) 194 (15) (13) 238 29 35
Meningitis 520 18 22 316 16 20 122 12 15 82 37 47
Bexsero 334 26 30 168 27 31 120 15 17 46 53 73
Menveo 173 3 7 148 6 10 1 (67) (33) 24 (4) (8)
Other 13 86 100 - - - 1 (50) (50) 12 >100 >100
RSV 188 (73) (72) 177 (75) (74) 5 >100 >100 6 (14) (29)
Arexvy 188 (73) (72) 177 (75) (74) 5 >100 >100 6 (14) (29)
Influenza 283 (24) (22) 243 (23) (21) 15 (29) (29) 25 (31) (22)
Fluarix, FluLaval 283 (24) (22) 243 (23) (21) 15 (29) (29) 25 (31) (22)
Established Vaccines 920 6 10 415 21 26 186 9 12 319 (10) (6)
Infanrix, Pediarix 151 4 8 95 16 21 27 4 8 29 (22) (19)
Boostrix 211 25 30 141 15 19 35 21 21 35 >100 >100
Hepatitis 183 17 22 112 18 22 46 15 20 25 14 27
Rotarix 153 6 10 52 53 59 29 4 7 72 (12) (10)
Synflorix 50 (44) (42) - - - 4 (50) (50) 46 (43) (41)
Priorix, Priorix Tetra, 83 1 4 12 >100 >100 32 (9) (6) 39 (9) (5)
Varilrix
Cervarix 18 (42) (42) - - - 4 100 100 14 (52) (52)
Other 71 39 41 3 (40) - 9 >100 >100 59 34 34
Vaccines excluding 2,650 (18) (15) 1,458 (29) (26) 522 (1) 1 670 4 10
COVID-19 solutions
Pandemic vaccines - (100) >(100) - - - - - - - (100) >(100)
Pandemic adjuvant - (100) >(100) - - - - - - - (100) >(100)
Vaccines 2,650 (18) (15) 1,458 (29) (26) 522 (1) 1 670 4 9
Vaccines turnover - nine months ended 30 September 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Shingles 2,516 (1) 2 1,078 (23) (20) 667 (2) (1) 771 68 76
Shingrix 2,516 (1) 2 1,078 (23) (20) 667 (2) (1) 771 68 76
Meningitis 1,142 16 20 580 14 17 339 3 5 223 52 60
Bexsero 783 15 19 325 18 22 331 5 7 127 46 56
Menveo 337 15 19 255 8 11 5 (44) (33) 77 60 65
Other 22 37 44 - - - 3 (25) (25) 19 58 67
RSV 432 (39) (37) 387 (45) (43) 6 >100 >100 39 >100 >100
Arexvy 432 (39) (37) 387 (45) (43) 6 >100 >100 39 >100 >100
Influenza 303 (26) (23) 244 (23) (21) 14 (33) (33) 45 (36) (31)
Fluarix, FluLaval 303 (26) (23) 244 (23) (21) 14 (33) (33) 45 (36) (31)
Established Vaccines 2,533 2 5 1,012 1 4 542 (2) - 979 4 9
Infanrix, Pediarix 390 (4) (1) 206 (8) (5) 87 10 13 97 (7) (2)
Boostrix 532 13 16 337 7 10 104 13 15 91 42 50
Hepatitis 521 7 11 295 7 10 143 8 11 83 8 14
Rotarix 431 (8) (4) 137 (14) (11) 88 (1) 1 206 (6) -
Synflorix 157 (31) (28) - - - 7 (74) (74) 150 (25) (22)
Priorix, Priorix Tetra, 240 27 31 26 >100 >100 93 (5) (3) 121 51 58
Varilrix
Cervarix 66 (40) (38) - - - 11 (63) (63) 55 (31) (29)
Other 196 41 44 11 (42) (37) 9 80 60 176 53 57
Vaccines excluding 6,926 (3) - 3,301 (16) (13) 1,568 (1) 1 2,057 27 33
COVID-19 solutions
Pandemic vaccines - (100) (100) - - - - (100) (100) - (100) (100)
Pandemic adjuvant - (100) (100) - - - - (100) (100) - (100) (100)
Vaccines 6,926 (5) (2) 3,301 (16) (13) 1,568 (8) (7) 2,057 25 31
Specialty Medicines turnover - three months ended 30 September 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
HIV 1,750 8 12 1,172 8 12 363 5 7 215 13 18
Dolutegravir products 1,388 2 6 867 - 4 318 2 4 203 12 15
Tivicay 335 (1) 2 187 (3) 1 60 (6) (5) 88 5 8
Triumeq 323 (13) (10) 230 (13) (9) 52 (20) (20) 41 (9) (2)
Juluca 163 (5) (1) 128 (4) 1 31 (9) (9) 4 33 -
Dovato 567 19 23 322 16 21 175 17 20 70 40 44
Rukobia 39 30 37 37 32 36 2 - - - - -
Cabenuva 245 35 40 200 32 38 39 50 54 6 20 20
Apretude 69 86 95 66 78 86 - - - 3 - -
Other 9 (31) (31) 2 (60) >(100) 4 (20) - 3 - 33
Respiratory/Immunology 843 10 14 555 5 9 139 17 20 149 22 29
and Other
Nucala 444 8 12 235 (2) 2 114 18 19 95 27 36
Benlysta 389 11 16 318 11 15 28 12 16 43 16 22
Other 10 43 43 2 >100 >100 (3) - 67 11 10 -
Oncology 373 86 94 264 >100 >100 88 22 24 21 24 41
Zejula 144 3 6 72 1 4 55 2 4 17 13 27
Blenrep 3 (70) (80) - - - 3 (70) (80) - - -
Jemperli 130 >100 >100 106 >100 >100 21 >100 >100 3 >100 >100
Ojjaara/Omjjara 98 >100 >100 86 >100 >100 11 - - 1 - -
Other (2) >(100) >(100) - - - (2) >(100) >(100) - >(100) -
Specialty Medicines 2,966 14 19 1,991 15 20 590 10 12 385 17 23
excluding COVID-19
solutions
Pandemic - - - - - - - - - - - -
Xevudy - - - - - - - - - - - -
Specialty Medicines 2,966 14 19 1,991 15 20 590 10 12 385 17 23
Specialty Medicines turnover - nine months ended 30 September 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
HIV 5,120 10 13 3,394 11 14 1,109 6 8 617 10 16
Dolutegravir products 4,083 3 6 2,520 2 5 981 3 4 582 9 14
Tivicay 1,007 (3) - 566 (4) (1) 190 (5) (3) 251 - 5
Triumeq 979 (14) (11) 682 (13) (10) 172 (20) (19) 125 (13) (8)
Juluca 496 2 6 391 5 9 95 (8) (6) 10 - -
Dovato 1,601 23 26 881 21 24 524 19 21 196 50 56
Rukobia 110 34 39 104 37 41 6 20 20 - >(100) -
Cabenuva 703 45 49 575 43 48 110 55 58 18 50 58
Apretude 195 >100 >100 189 95 >100 - - - 6 - -
Other 29 (34) (32) 6 (57) (64) 12 (25) (19) 11 (21) (14)
Respiratory/Immunology 2,389 10 15 1,570 6 10 409 19 22 410 19 29
and Other
Nucala 1,300 10 14 702 2 6 335 19 21 263 21 32
Benlysta 1,067 11 15 866 10 13 85 16 19 116 17 25
Other 22 22 33 2 >100 - (11) - 9 31 11 18
Oncology 1,002 >100 >100 701 >100 >100 249 14 16 52 49 57
Zejula 450 21 25 232 35 39 174 5 7 44 33 39
Blenrep 1 (97) (97) (3) (50) (50) 4 (88) (88) - - -
Jemperli 318 >100 >100 259 >100 >100 52 >100 >100 7 >100 >100
Ojjaara/Omjjara 235 >100 >100 213 >100 >100 21 - - 1 - -
Other (2) >(100) >(100) - - - (2) >(100) >(100) - >(100) -
Specialty Medicines 8,511 16 20 5,665 19 22 1,767 10 12 1,079 15 22
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 8,512 16 20 5,665 19 23 1,767 10 12 1,080 11 18
General Medicines turnover - three months ended 30 September 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Respiratory 1,617 6 11 820 10 15 338 7 9 459 1 7
Anoro Ellipta 146 3 6 67 (6) (1) 56 17 19 23 - 4
Flixotide/Flovent 113 15 20 73 11 15 15 25 33 25 25 30
Relvar/Breo Ellipta 241 1 5 86 - 3 85 5 7 70 (3) 4
Seretide/Advair 218 8 13 61 >100 >100 50 (9) (7) 107 (17) (12)
Trelegy Ellipta 600 12 16 420 8 13 79 14 17 101 26 31
Ventolin 176 1 5 90 (2) 1 25 4 4 61 3 12
Other Respiratory 123 (3) 2 23 (12) (4) 28 - - 72 (1) 4
Other General Medicines 779 (5) - 52 30 37 168 (5) (4) 559 (7) (1)
Augmentin 146 (8) (1) - - - 43 5 7 103 (12) (4)
Lamictal 94 13 18 37 61 70 27 (4) (4) 30 (6) -
Other "Other General Medicines" 539 (6) (2) 15 (12) (6) 98 (9) (8) 426 (6) -
General Medicines 2,396 3 7 872 11 16 506 2 4 1,018 (4) 2
General Medicines turnover - nine months ended 30 September 2024
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Respiratory 5,407 6 11 2,912 15 19 1,055 1 3 1,440 (5) 2
Anoro Ellipta 425 6 9 192 1 4 164 15 18 69 - 6
Flixotide/Flovent 384 9 13 259 15 19 51 2 4 74 (3) 3
Relvar/Breo Ellipta 792 (1) 3 300 (2) 1 275 1 4 217 (3) 5
Seretide/Advair 798 (8) (4) 273 4 7 166 (13) (12) 359 (12) (7)
Trelegy Ellipta 2,033 26 31 1,512 29 33 230 13 15 291 24 33
Ventolin 532 (3) - 276 (4) (1) 76 6 7 180 (6) (1)
Other Respiratory 443 (11) (7) 100 25 29 93 (16) (15) 250 (19) (13)
Other General Medicines 2,414 (6) (1) 179 (16) (13) 521 (4) (3) 1,714 (5) 1
Augmentin 474 1 6 - - - 138 1 2 336 1 8
Lamictal 304 (7) (3) 123 (15) (12) 81 (2) (1) 100 1 8
Other "Other General Medicines" 1,636 (8) (2) 56 (19) (14) 302 (7) (5) 1,278 (7) (1)
General Medicines 7,821 2 7 3,091 13 16 1,576 (1) 1 3,154 (5) 1
Commercial Operations turnover
Total US Europe International
Growth Growth Growth Growth
£m £% CER% £m £% CER% £m £% CER% £m £% CER%
Three months ended 30 September 2024 8,012 (2) 2 4,321 (5) (1) 1,618 4 6 2,073 2 8
Nine months ended 30 September 2024 23,259 4 8 12,057 5 9 4,911 - 2 6,291 6 12
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 September 2024 8,012 (2) 2 4,321 (5) (1) 1,618 4 6 2,073 2 8
Nine months ended 30 September 2024 23,258 5 9 12,057 5 9 4,911 3 5 6,290 7 13
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
Q3 2024 Q3 2023 Growth Growth
£m £m £% CER%
Commercial Operations (total turnover) 8,012 8,147 (2) 2
Operating profit by segment
Q3 2024 Q3 2023 Growth Growth
£m £m £% CER%
Commercial Operations 4,195 4,188 - 5
Research and Development (1,334) (1,371) (3) -
Segment profit 2,861 2,817 2 7
Corporate and other unallocated costs (100) (45)
Core operating profit 2,761 2,772 - 5
Adjusting items (2,572) (823)
Total operating profit 189 1,949 (90) (86)
Finance income 32 24
Finance costs (156) (182)
Share of after tax profit/(loss) of associates and (1) -
joint ventures
Profit before taxation 64 1,791 (96) (92)
Commercial Operations Core operating profit of £4,195 million grew in the
quarter from strong Specialty Medicines sales performance, 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 continued disciplined
investment in growth assets and lower royalty income.
The R&D segment operating expense of £1,334 million in the quarter
reflected continued spend across the portfolio, with Specialty Medicines spend
driven by camlipixant, bepirovirsen and depemokimab as well as the long acting
TSLP asset acquired as part of the Aiolos acquisition, and in HIV on
long-acting medicines. In Vaccines, pneumococcal (MAPS) and mRNA continued to
drive investment, and, in Oncology, increased investment in Jemperli and ADC
assets was offset by cost decreases following the launches of Arexvy and
Ojjaara, and progression to completion of Zejula and Blenrep studies.
Turnover by segment
9 months 2024 9 months 2023 Growth Growth
£m £m £% CER%
Commercial Operations (total turnover) 23,259 22,276 4 8
Operating profit by segment
9 months 2024 9 months 2023 Growth Growth
£m £m £% CER%
Commercial Operations 12,012 11,044 9 14
Research and Development (4,055) (3,876) 5 7
Segment profit 7,957 7,168 11 17
Corporate and other unallocated costs (240) (134)
Core operating profit 7,717 7,034 10 16
Adjusting items (4,392) (862)
Total operating profit 3,325 6,172 (46) (41)
Finance income 88 86
Finance costs (496) (570)
Share of after tax profit/(loss) of associates (3) (4)
and joint ventures
Profit/(loss) on disposal of associates and joint ventures - 1
Profit before taxation 2,914 5,685 (49) (43)
Commercial Operations Core operating profit of £12,012 million grew year to
date driven by continued leverage from strong sales and favourable product and
regional mix, as well as price benefits from channel mix and adjustments to
returns and rebates in the US, and a reversal of the Zejula royalty dispute
legal provision in Q1 2024, partly offset by continued disciplined investment
in growth assets and lower royalty income.
The R&D segment operating expense of £4,055 million grew year to date
driven by continued spend across the portfolio, with a significant increase in
investment in Specialty Medicines including camlipixant, bepirovirsen and
depemokimab as well as the long acting TSLP asset acquired as part of the
Aiolos acquisition. In addition, there was continued spend in HIV on
long-acting medicines. In Vaccines, pneumococcal (MAPS) and mRNA continued to
drive investment, and, in Oncology, increased investment in Jemperli and ADC
assets was offset by cost decreases following the launches of Arexvy and
Ojjaara, and progression to completion of Zejula and Blenrep studies.
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 September
2024, the Group's aggregate provision for legal and other disputes (not
including tax matters described on page 10) was £2,033 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 Q2 2024 results:
Product Liability
Zantac
On 9 October 2024 GSK reached agreements with 10 plaintiff firms who together
represent 93% (approximately 80,000 claimants) of the Zantac state court
product liability cases pending against GSK in the United States. Under these
agreements, GSK will make an aggregate payment of up to $2.2 billion to
resolve all U.S. state court product liability cases handled by these
plaintiff firms that meet agreed eligibility and participation criteria (the
"State Courts Settlement"). The participating plaintiff firms are unanimously
recommending to their clients that they accept the terms of the State Courts
Settlement, which is expected to be fully implemented by the end of H1 2025.
Terms of the agreements are confidential.
On 9 October 2024 GSK also reached an agreement in principle to pay a total of
$70 million to resolve the Zantac qui tam complaint previously filed by
Valisure. The agreement in principle is subject to final approval from the
Department of Justice (the "Qui Tam Settlement").
GSK has not admitted any liability in the State Courts Settlement or in the
agreement in principle for the Qui Tam Settlement. While the scientific
consensus remains that there is no consistent or reliable evidence that Zantac
increases the risk of any cancer, GSK strongly believes that these settlements
are in the best long-term interests of the company and its shareholders as
they remove significant financial uncertainty, risk and distraction associated
with protracted litigation.
There remain approximately 6,000 cases filed in various state court
jurisdictions, the vast majority of which are in Delaware. On 27 August 2024,
the Delaware Supreme Court accepted Defendants' appeal of the Superior Court's
decision allowing Plaintiffs to present expert evidence of general causation
on all ten cancer types to a jury.
The State Courts Settlement resolved all state court product liability trials
which were scheduled for 2024 and 2025.
As previously disclosed, approximately 14,000 product liability cases were
dismissed following the grant of defendants' Daubert motions in December 2022
in the MDL proceeding. These are now on appeal by the plaintiffs to the United
States Court of Appeals for the Eleventh Circuit, along with appeals in the
medical monitoring and consumer class action cases. GSK remains confident in
its position and will continue to vigorously defend against those appeals.
The trial in the Mayor & City of Baltimore action is scheduled to begin 1
June 2026.
GSK took a charge in Q3 2024 of £1.8 billion ($2.3 billion) in relation to
the State Courts Settlement, the Qui Tam Settlement, and the remaining 7% of
pending state court product liability cases, partially offset by reduced
future legal costs.
Intellectual Property
RSV
On 5 August 2024, GSK filed a patent infringement suit against Pfizer in the
European Unified Patent Court ("UPC") alleging infringement of a single GSK
patent by Pfizer's RSV vaccine, Abrysvo. On 14 August 2024, Pfizer filed a
separate action in the UPC seeking revocation of the patent. First instance
decisions on the merits are not expected until late 2025.
On 7 October 2024, the London High Court ruled in Pfizer's favour and
invalidated two of GSK's patents relating to RSV vaccine technology. GSK plans
to appeal that decision.
mRNA
On 14 August 2024, GSK filed a First Amended Complaint in the United States
District Court for the District of Delaware asserting 3 additional GSK patents
against Pfizer/BioNTech bringing the total number of asserted patents to 8.
Pfizer/BioNTech filed an Answer and Counterclaims to GSK's First Amended
Complaint on 30 August 2024. Trial has yet to be scheduled.
On 12 October 2024, GSK filed two separate patent infringement suits against
Moderna, Inc. in the United States District Court for the District of
Delaware. The first suit alleges infringement of 7 GSK patents by the COVID-19
vaccine, SPIKEVAX. The second suit alleges infringement of 6 GSK patents by
the RSV vaccine, mRESVIA.
Returns to shareholders
Quarterly dividends
The Board has declared a third interim dividend for Q3 2024 of 15p per share
(Q3 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 Q3 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 7 January 2025. An annual fee of $0.03 per ADS
(or $0.0075 per ADS per quarter) is charged by the Depositary. The ex-dividend
and record dates will be 15 November 2024 with a payment date of 9 January
2025.
Paid/ Pence per £m
Payable share
2024
First interim 11 July 2024 15 612
Second interim 10 October 2024 15 612
Third interim 9 January 2025 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 September 2024, 4,080 million shares (Q3 2023: 4,056 million) were in
free issue (excluding Treasury shares and shares held by the ESOP Trusts). No
Treasury shares have been repurchased since 2014. In the quarter, the company
issued a small number of shares under employee share schemes for proceeds of
£1 million (Q3 2023: nil).
At 30 September 2024, the ESOP Trusts held 64.6 million shares of GSK shares,
of which 64.3 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 £431 million has been deducted from other
reserves. The market value of these shares was £980 million.
At 30 September 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
Q3 2024 Q3 2023 9 months 2024 9 months 2023
millions millions millions millions
Weighted average number of shares - basic 4,080 4,055 4,076 4,050
Dilutive effect of share options and share awards 61 57 61 58
Weighted average number of shares - diluted 4,141 4,112 4,137 4,108
Additional information
Accounting policies and basis of preparation
This unaudited Results Announcement contains condensed financial information
for the three and nine months ended 30 September 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:
Q3 2024 Q3 2023 9 months 2024 9 months 2023 2023
Average rates:
US$/£ 1.31 1.26 1.28 1.24 1.24
Euro/£ 1.19 1.16 1.18 1.15 1.15
Yen/£ 192 182 192 173 175
Period-end rates:
US$/£ 1.34 1.23 1.34 1.23 1.27
Euro/£ 1.20 1.16 1.20 1.16 1.15
Yen/£ 191 183 191 183 180
Contingent liabilities
There were contingent liabilities at 30 September 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 £658 million from £12,795 million
at 31 December 2023 to £13,453 million at 30 September 2024. This primarily
reflected contribution from Total comprehensive income for the period partly
offset by dividends paid to shareholders.
At 30 September 2024, the net deficit on the Group's pension plans was £175
million compared with £764 million at 31 December 2023. This decrease in the
net deficit is primarily due to an increase in the UK discount rate, partly
offset by a decrease in the US discount 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 £902 million (31 December 2023: £848 million).
Contingent consideration amounted to £7,125 million at 30 September 2024 (31
December 2023: £6,662 million), of which £5,924 million (31 December 2023:
£5,718 million) represented the estimated present value of amounts payable to
Shionogi relating to ViiV Healthcare, £575 million (31 December 2023: £424
million) represented the estimated present value of contingent consideration
payable to Novartis related to the Vaccines acquisition, £520 million (31
December 2023: £516 million) represented the estimated present value of
contingent consideration payable to Affinivax, and £95 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 September 2024, £1,054 million (31
December 2023: £1,017 million) is expected to be paid within one year.
Movements in contingent consideration are as follows:
9 months 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 1,106 1,294
Cash payments: operating cash flows (900) (924)
Cash payments: investing activities - (11)
Contingent consideration at end of the period 5,924 7,125
9 months 2023 ViiV Group
Healthcare £m
£m
Contingent consideration at beginning of the period 5,890 7,068
Remeasurement through income statement and other movements 406 302
Cash payments: operating cash flows (834) (853)
Cash payments: investing activities - (7)
Contingent consideration at end of the period 5,462 6,510
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
As at 30 September 2024, the present value of the contingent consideration
payable was £95 million.
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
9 months 2024 9 months 2023
£m £m
Total Net debt at beginning of the period (15,040) (17,197)
Increase/(decrease) in cash and bank overdrafts 231 (340)
Increase/(decrease) in liquid investments (21) (47)
Net (increase)/repayment of short-term loans 1,410 (306)
Repayment of long-term notes - (94)
Repayment of lease liabilities 170 148
Net debt of subsidiary undertakings acquired - 50
Exchange adjustments 504 304
Other non-cash movements (101) (107)
(Increase)/decrease in net debt 2,193 (392)
Total Net debt at end of the period (12,847) (17,589)
Net debt analysis
30 September 2024 31 December 2023
£m £m
Liquid investments 20 42
Cash and cash equivalents 3,192 2,936
Short-term borrowings (2,815) (2,813)
Long-term borrowings (13,244) (15,205)
Total Net debt at the end of the period (12,847) (15,040)
Free cash flow reconciliation
Q3 2024 Q3 2023 9 months 2024 9 months 2023
£m £m £m £m
Net cash inflow/(outflow) from operating activities 2,154 2,212 4,225 3,572
Purchase of property, plant and equipment (305) (299) (855) (828)
Proceeds from sale of property, plant and equipment 1 11 4 21
Purchase of intangible assets (537) (198) (992) (733)
Proceeds from disposals of intangible assets 98 - 126 12
Net finance costs (13) (11) (294) (397)
Dividends from associates and joint ventures - - 15 1
Contingent consideration paid (reported in investing activities) (4) (3) (11) (7)
Distributions to non-controlling interests (80) (57) (288) (334)
Contributions from non-controlling interests 8 - 9 7
Free cash inflow/(outflow) 1,322 1,655 1,939 1,314
Post balance sheet event
GSK plc announced on 9 October 2024 that it has reached agreements with 10
plaintiff firms who together represent 93% (approximately 80,000) of the
Zantac state court product liability cases pending against GSK in the United
States. Under these agreements, GSK will make an aggregate payment of up to
$2.2 billion to resolve all U.S. state court product liability cases handled
by those plaintiff firms that meet agreed eligibility and participation
criteria (the "State Courts Settlement"). GSK also confirmed that it has
reached an agreement in principle to pay a total of $70 million to resolve the
Zantac qui tam complaint previously filed by Valisure. The agreement in
principle is subject to final approval from the Department of Justice (the
"Qui Tam Settlement"). GSK has not admitted any liability in the State Courts
Settlement or in the agreement in principle for the Qui Tam Settlement.
GSK has recognised a charge in Q3 2024 of £1.8 billion ($2.3 billion) in
relation to the State Courts Settlement, the Qui Tam Settlement, and the
remaining 7% of pending state court product liability cases, partially offset
by reduced future legal costs. Further details are set out on page 38.
Related party transactions
Details of GSK's related party transactions are disclosed on page 235 of our
2023 Annual Report.
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 (18-59 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 67
Total projects in clinical development (inclusive of all phases and 88
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 August 2024, the European Commission authorised the extended use of Arexvy
for the prevention of lower respiratory tract disease (LRTD) caused by RSV to
adults 50 to 59 years of age at increased risk. This follows US approval in
this population earlier this year. Regulatory review is ongoing in Japan and
other countries.
New data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III
trial showed clinically meaningful efficacy over three full RSV seasons
against RSV-LRTD and severe LRTD with one dose in adults aged 60 years and
older. These results were presented at the CHEST 2024 Annual Meeting, and
included efficacy against different RSV subtypes, in adults with advancing age
(70-79 years of age), and those with certain underlying medical conditions.
Safety and reactogenicity data were consistent with initial observation from
the phase III programme.
Positive data were also reported showing the vaccine's efficacy and safety in
adults aged 18 and above at increased risk from RSV, including
immunocompromised patients. In addition, positive data on its
co-administration with Shingrix were presented at the European Geriatric
Medicine Society meeting (EuGMS) in September 2024. These results indicated a
non-inferior immune response of both AS01-adjuvanted vaccines when
administered together, with acceptable reactogenicity and safety profiles,
further strengthening the body of evidence supporting their use.
Key phase III trials for Arexvy:
Trial name (population) Phase Design Timeline Status
RSV OA=ADJ-004 III A randomised, open-label, multi-country trial to evaluate the immunogenicity, Trial start: Active, not recruiting; primary endpoint met
safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA
(Adults ≥ 60 years old) investigational vaccine and different revaccination schedules in adults aged Q1 2021
60 years and above
NCT04732871 Primary data reported:
Q2 2022
RSV OA=ADJ-006 III A randomised, placebo-controlled, observer-blind, multi-country trial to Trial start: Complete; primary endpoint met
demonstrate the efficacy of a single dose of GSK's RSVPreF3 OA investigational
(ARESVI-006; Adults ≥ 60 years old) vaccine in adults aged 60 years and above Q2 2021
NCT04886596 Primary data reported:
Q2 2022;
two season data reported:
Q2 2023;
three season data reported: Q3 2024
RSV OA=ADJ-007 III An open-label, randomised, controlled, multi-country trial to evaluate the Trial start: Complete; primary endpoint met
immune response, safety and reactogenicity of RSVPreF3 OA investigational
(Adults ≥ 60 years old) vaccine when co-administered with FLU-QIV vaccine in adults aged 60 years and Q2 2021
above
NCT04841577 Primary data reported:
Q4 2022
RSV OA=ADJ-008 III A phase III, open-label, randomised, controlled, multi country trial to Trial start: Complete; primary endpoint met
evaluate the immune response, safety and reactogenicity of RSVPreF3 OA
investigational vaccine when co-administered with FLU HD vaccine in adults Q4 2022
aged 65 years and above
(Adults ≥ 65 years old)
Primary data reported:
NCT05559476 Q2 2023
RSV OA=ADJ-009 III A randomised, double-blind, multi-country trial to evaluate consistency, Trial start: Complete; primary endpoint met
safety, and reactogenicity of 3 lots of RSVPreF3 OA investigational vaccine
(Adults ≥ 60 years old) administrated as a single dose in adults aged 60 years and above Q4 2021
NCT05059301 Trial end:
Q2 2022
RSV OA=ADJ-017 III A phase III, open-label, randomised, controlled, multi-country trial to Trial start: Complete; data analysis ongoing
evaluate the immune response, safety and reactogenicity of an RSVPreF3 OA
(Adults ≥ 65 years old) investigational vaccine when co-administered with FLU aQIV (inactivated Q4 2022
influenza vaccine - adjuvanted) in adults aged 65 years and above
NCT05568797 Primary data reported:
Q2 2023
Key phase III trials for Arexvy (continued):
Trial name (population) Phase Design Timeline Status
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; primary endpoint met
safety of the RSVPreF3 OA investigational vaccine in adults (≥50 years of
(Immunocompromised Adults 50-59 years) age) when administered to lung and renal transplant recipients comparing one Q3 2023
versus two doses and compared to healthy controls (≥50 years of age)
receiving one dose Primary data reported:
NCT05921903 Q4 2024
RSV-OA=ADJ-020 III A study on the safety and immune response of investigational RSV OA vaccine in Trial start: Active, not recruiting; primary endpoint met
combination with herpes zoster vaccine in healthy adults
(Adults aged >=50 years of age) Q3 2023
NCT05966090 Primary data reported:
Q3 2024
RSV-OA=ADJ-013 III An open-label, randomized, controlled study to evaluate the immune response, Trial start: Active, not recruiting
safety and reactogenicity of RSVPreF3 OA investigational vaccine when
(Adults aged 50 years and above) co-administered with a COVID-19 mRNA vaccine Q2 2024
NCT06374394 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: Active, not recruiting; primary endpoint met
to evaluate the safety of the RSVPreF3 OA investigational vaccine in adults
(Adults, 18-49 years of age, at increased risk for RSV disease and older 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
Primary data reported:
NCT06389487
Q4 2024
RSV OA=ADJ-021 III A study on the immune response, safety and the occurrence of Respiratory Trial start: Recruiting
Syncytial Virus (RSV)-associated respiratory tract illness after
(Adults aged 60 years and above) administration of RSV OA vaccine in adults 60 years and older Q3 2024
NCT06551181 Data anticipated:
H2 2025
RSV OA+ADJ-012 An Extension and Crossover Vaccination Study on the Immune Response and Safety Trial start: Q3 2024 Recruiting
of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of
(Adults aged 60 years and above) Age and Above Who Participated in RSV OA=ADJ-006 Study Data anticipated: 2026
NCT06534892
bepirovirsen (HBV ASO)
Bepirovirsen, a triple-action antisense oligonucleotide, is a potential new
treatment option for people with chronic hepatitis B (CHB). Based on the
potential to address an unmet medical need for a serious and life-threatening
condition, bepirovirsen has been granted Fast Track designation by the US FDA
and SENKU designation by the Japanese Ministry of Health, Labour and Welfare
for the treatment of CHB. The B-Well 1 and 2 phase III trials are on track and
have achieved full recruitment ahead of schedule.
This quarter GSK received FDA approval to start phase II combination studies
with daplusiran/tomligisiran (GSK5637608, formerly JNJ-3989), an
investigational hepatitis B virus-targeted small interfering ribonucleic acid
(siRNA) therapeutic, as a novel sequential regimen to pursue functional cure
in an even broader CHB patient population.
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.
In October 2024, a regulatory submission in uUTI was accepted by the US FDA
under Priority Review. A decision on approval is expected in March 2025. If
approved, gepotidacin could be the first in a new class of oral antibiotics in
uUTI in over 20 years. Filings for gonorrhoea are expected to follow in 2025.
Key phase III trials for gepotidacin:
Trial name (population) Phase Design Timeline Status
EAGLE-1 (uncomplicated urogenital gonorrhoea) III A randomised, multi-centre, open-label trial in adolescent and adult Trial start: Complete;
participants comparing the efficacy and safety of gepotidacin to ceftriaxone
plus azithromycin in the treatment of uncomplicated urogenital gonorrhoea Q4 2019 primary endpoint met
caused by Neisseria gonorrhoeae
NCT04010539
Data reported:
Q1 2024
EAGLE-2 (females with uUTI / acute cystitis) III A randomised, multi-centre, parallel-group, double-blind, double-dummy trial Trial start: Complete; primary endpoint met
in adolescent and adult female participants comparing the efficacy and safety
of gepotidacin to nitrofurantoin in the treatment of uncomplicated urinary Q4 2019
tract infection (acute cystitis)
NCT04020341
Data reported:
Q2 2023
EAGLE-3 (females with uUTI / acute cystitis) III A randomised, multi-centre, parallel-group, double-blind, double-dummy trial Trial start: Complete; primary endpoint met
in adolescent and adult female participants comparing the efficacy and safety
of gepotidacin to nitrofurantoin in the treatment of uncomplicated urinary Q2 2020
tract infection (acute cystitis)
NCT04187144
Data reported:
Q2 2023
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 in the US.
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 October 2024, the cost effectiveness analysis and grading for MenABCWY were
discussed 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
GSK continues to transform the HIV marketplace through its oral two-drug and
long-acting injectable regimens for the treatment and prevention of HIV.
cabotegravir
In October 2024, ViiV Healthcare presented 22 abstracts at the ID Week
congress. These data included real-world evidence from the OPERA and Trio
Health cohorts showing more than 99% effectiveness of Apretude (cabotegravir
long-acting (LA)) for HIV pre-exposure prophylaxis (PrEP). In addition,
patient-reported results from the implementation study, PILLAR, were reported,
showing a reduction in stigma and anxiety when using long-acting injectable
PrEP. These studies add to the growing body of evidence reinforcing the
real-world impact of this medicine today and offer new insight for healthcare
providers seeking to optimise care to suit individual needs and circumstances.
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:
H2 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:
H2 2025
depemokimab (long acting anti-IL5)
Depemokimab is in late-stage development in a range of IL-5 mediated
conditions including, severe asthma, chronic rhinosinusitis with nasal polyps
(CRSwNP), hypereosinophilic syndrome (HES) and eosinophilic granulomatosis
with polyangiitis (EGPA). It is the first ultra-long-acting biologic
engineered to have an extended half-life and high binding affinity and potency
for IL-5, enabling six-month dosing intervals for patients with severe asthma.
The phase III programme for depemokimab continues to make progress. In
September 2024, the full positive results from the pivotal SWIFT-1 and SWIFT-2
trials evaluating the efficacy and safety of depemokimab in severe asthma with
type 2 inflammation were presented at the European Respiratory Society
International Conference with simultaneous publication in the New England
Journal of Medicine. Both trials met their primary endpoints with
statistically significant reductions in the annualised rate of clinically
significant exacerbations (asthma attacks) over 52 weeks versus placebo. The
pre-specified pooled analysis showed a 54% reduction in exacerbations (Rate
Ratio 0.46, 95% CI, 0.36 - 0.59, p<0.001) (AER depemokimab = 0.51
exacerbations per year versus placebo = 1.11) and a 72% reduction(*) in the
secondary endpoint of clinically significant exacerbations requiring
hospitalisation or emergency department visit compared to placebo (RR 0.28,
95% CI 0.13 - 0.61, p=0.002) (AER: depemokimab = 0.02 versus placebo = 0.09).
In October 2024, positive headline results were announced from the ANCHOR-1
and ANCHOR-2 phase III trials assessing the safety and efficacy of depemokimab
in patients with CRSwNP. Both trials met their co-primary endpoints with a
statistically significant reduction in nasal polyp size and nasal obstruction
versus placebo plus standard of care, at 52 weeks. Further analysis of these
data is ongoing and the full results will be presented at an upcoming
scientific congress.
Data from SWIFT-1 and -2 along with ANCHOR-1 and -2 will be used to support
regulatory submissions to health authorities worldwide.
Footnotes:
(*) As the pooled analysis of SWIFT-1 and SWIFT-2 did not control for multiple
comparisons, results with a significant p-value (>0.05) are termed
nominally significant.
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: Complete; 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: Complete; 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:
H1 2025
NIMBLE (SEA) III A 52-week, randomised, double-blind, double-dummy, parallel group, Trial start: Active, not recruiting
multi-centre, non-inferiority trial assessing exacerbation rate, additional
measures of asthma control and safety in adult and adolescent severe asthmatic Q1 2021
participants with an eosinophilic phenotype treated with depemokimab compared
NCT04718389 with mepolizumab or benralizumab
Data anticipated:
H2 2025
ANCHOR-1 (chronic rhinosinusitis with nasal polyps; CRSwNP) III Efficacy and safety of depemokimab in participants with CRSwNP Trial start: Complete; primary endpoint met
Q2 2022
NCT05274750
Data reported: Q3 2024
ANCHOR-2 (CRSwNP) III Efficacy and safety of depemokimab in participants with CRSwNP Trial start: Complete; primary endpoint met
Q2 2022
NCT05281523
Data reported:
Q3 2024
OCEAN (eosinophilic granulomatosis with polyangiitis; EGPA) III Efficacy and safety of depemokimab compared with mepolizumab in adults with Trial start: Recruiting
relapsing or refractory EGPA
Q3 2022
NCT05263934
Data anticipated:
2026+
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.
In September 2024, positive results from MATINEE, a phase III trial
investigating Nucala in patients with chronic obstructive pulmonary disease
(COPD) were announced. MATINEE met its primary endpoint with the addition of
Nucala to inhaled maintenance therapy showing a statistically significant and
clinically meaningful reduction in the annualised rate of moderate/severe
exacerbations versus placebo, with patients treated for up to 104 weeks.
The full results of MATINEE will be presented at a future scientific congress
and will inform ongoing discussions with regulatory authorities.
Key trials for Nucala:
Trial name (population) Phase Design Timeline Status
MATINEE (chronic obstructive pulmonary disease; COPD) III A multicentre randomised, double-blind, parallel-group, placebo-controlled Trial start: Active, not recruiting; primary endpoint met
trial of mepolizumab 100 mg subcutaneously as add-on treatment in participants
with COPD experiencing frequent exacerbations and characterised by eosinophil Q4 2019
levels
NCT04133909
Data reported:
Q3 2024
Oncology
Blenrep (belantamab mafodotin)
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.
GSK is pursuing regulatory approvals based on positive results from the phase
III head-to-head DREAMM-7 and DREAMM-8 trials, which found that the
belantamab-mafodotin-based combinations studied reduced the risk of disease
progression or death by nearly 60% and 50% respectively versus standards of
care in patients with relapsed or refractory multiple myeloma.
In September 2024, Japan's Ministry of Health, Labour and Welfare (MHLW)
accepted for review a new drug application (NDA) based on DREAMM-7 and
DREAMM-8. MHLW also granted an orphan drug designation for belantamab
mafodotin, which reflects the high unmet medical need and ensures priority NDA
review. This follows earlier marketing authorisation application acceptances
by regulatory agencies in Europe and the UK. A regulatory application has been
filed in the US.
In September 2024, the Center for Drug Evaluation (CDE) of the National
Medical Products Administration (NMPA) in China granted Breakthrough Therapy
Designation (BTD) for belantamab mafodotin combined with bortezomib plus
dexamethasone based on the results of DREAMM-7. NMPA BTD is intended to
expedite the development of therapies for serious and life-threatening
diseases for which there are no existing treatments or where initial evidence
has shown an improvement in patient outcomes over available treatment options.
A regulatory authorisation application in China is expected to be filed by the
end of 2024.
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 August 2024, the
US FDA approved Jemperli plus chemotherapy followed by Jemperli as a single
agent for the treatment of adult patients with primary advanced or recurrent
endometrial cancer. This approval broadens the previous indication to include
patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS)
tumours who represent 70-75% of patients diagnosed with endometrial cancer and
who have limited treatment options.
The expanded approval was based on results from Part 1 of the RUBY phase III
trial, which is the only clinical trial in this setting to show a
statistically significant overall survival benefit in the full population of
patients with primary advanced or recurrent endometrial cancer, demonstrating
a 31% reduction in risk of death (HR: 0.69; 95% CI: 0.54-0.89) compared to
chemotherapy alone.
The application received Priority Review and was approved ahead of the
Prescription Drug User Fee Act action date.
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: Active, not 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:
H1 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+
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
Reporting definitions
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.
Core Operating Margin
Core Operating margin is Core operating profit divided by turnover.
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.
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 43.
Free cash flow conversion
Free cash flow conversion is free cash flow from operations as a percentage of
profit attributable to shareholders.
General Medicines
General Medicines are usually prescribed in the primary care or community
settings by general healthcare practitioners. For GSK, this includes medicines
for inhaled respiratory, dermatology, antibiotics and other diseases.
Non-controlling interest
Non-controlling interest is the equity in a subsidiary not attributable,
directly or indirectly, to a parent.
Percentage points
Percentage points of growth which is abbreviated to ppts.
RAR (Returns and Rebates)
GSK sells to customers both commercial and government mandated contracts with
reimbursement arrangements that include rebates, chargebacks and a right of
return for certain pharmaceutical products principally in the US. Revenue
recognition reflects gross-to-net sales adjustments as a result. These
adjustments are known as the RAR accruals and are a source of significant
estimation uncertainty and fluctuation which can have a material impact on
reported revenue from one accounting period to the next.
Risk adjusted sales
Pipeline risk-adjusted sales are based on the latest internal estimate of the
probability of technical and regulatory success for each asset in development.
Specialty Medicines
Specialty Medicines are typically prescription medicines used to treat complex
or rare chronic conditions. For GSK, this comprises medicines for infectious
diseases, HIV, Respiratory/Immunology and Other, and Oncology.
Total Net debt
Net debt is defined as total borrowings less cash, cash equivalents, liquid
investments, and short-term loans to third parties that are subject to an
insignificant risk of change in value. The measure is used by management as it
is considered a good indicator of GSK's ability to meet its financial
commitments and the strength of its balance sheet.
Total and Core results
Total reported results represent the Group's overall performance. GSK uses a
number of non-IFRS measures to report the performance of its business. Core
results and other non-IFRS measures may be considered in addition to, but not
as a substitute for or superior to, information presented in accordance with
IFRS. Core results are defined on page 18 and other non-IFRS measures are
defined below.
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.
Total Operating Margin
Total Operating margin is Total operating profit divided by turnover.
Total Earnings/(loss) per share
Unless otherwise stated, Total earnings/(loss) per share refers to Total basic
earnings/(loss) per share.
Working capital
Working capital represents inventory and trade receivables less trade
payables.
Year to date
Year to date is the nine-month period in the year to 30 September 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 confirms its full-year sales, core profit and EPS guidance at constant
exchange rates (CER) and expects to deliver broadly around the middle of the
existing ranges. Turnover is expected to increase between 7 to 9 per cent.
Core operating profit is expected to increase between 11 to 13 per cent and
Core Earnings per share is expected to increase between 10 to 12 per cent.
The Group revises turnover expectations for Vaccines to a decrease of
low-single digit per cent, for Specialty Medicines to an increase of high
teens per cent and for General Medicines to an increase of 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 Q3 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.
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 nine months ended 30 September 2024.
The condensed financial information comprises:
• the income statement and statement of comprehensive income for the three and
nine month periods ended 30 September 2024 on page 26 and 27;
• the balance sheet as at 30 September 2024 on page 28;
• the statement of changes in equity for the nine-month period then ended on
page 29;
• the cash flow statement for the nine-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 43 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 nine months ended 30 September 2024 is not prepared, in all
material respects in accordance with the accounting policies set out in the
accounting policies and basis of preparation section on page 40.
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 40, the annual financial statements of the Company are
prepared in accordance with United Kingdom adopted international accounting
standards. The condensed set of financial information included in this Results
Announcement have been prepared in accordance with the accounting policies set
out in the accounting policies and basis of preparation section on page 40.
Conclusion Relating to Going Concern
Based on our review procedures, which are less extensive than those performed
in an audit as described in the Basis for Conclusion section of this report,
nothing has come to our attention to suggest that the directors have
inappropriately adopted the going concern basis of accounting or that the
directors have identified material uncertainties relating to going concern
that are not appropriately disclosed.
This Conclusion is based on the review procedures performed in accordance with
ISRE (UK) 2410, however future events or conditions may cause the entity to
cease to continue as a going concern.
Responsibilities of the directors
The directors are responsible for preparing the Results Announcement of the
company in accordance with the Disclosure Guidance and Transparency Rules of
the United Kingdom's Financial Conduct Authority.
In preparing the Results Announcement, the directors are responsible for
assessing the Company's ability to continue as a going concern, disclosing as
applicable, matters related to going concern and using the going concern basis
of accounting unless the directors either intend to liquidate the company or
to cease operations, or have no realistic alternative but to do so.
Auditor's Responsibilities for the review of the financial information
In reviewing the Results Announcement, we are responsible for expressing to
the company a conclusion on the condensed financial information in the Results
Announcement based on our review. Our Conclusion, including our Conclusion
Relating to Going Concern, are based on procedures that are less extensive
than audit procedures, as described in the Basis for Conclusion paragraph of
this report.
Use of our report
This report is made solely to the company in accordance with ISRE (UK) 2410.
Our work has been undertaken so that we might state to the company those
matters we are required to state to it in an independent review report and for
no other purpose. To the fullest extent permitted by law, we do not accept or
assume responsibility to anyone other than the company, for our review work,
for this report, or for the conclusions we have formed.
Deloitte LLP
Statutory Auditor
London, United Kingdom
29 October 2024
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