UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
REPORT
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the
month of October 2024
Commission File
Number 001-15170
GSK
plc
(Translation of
registrant's name into English)
79
New Oxford Street, London, WC1A 1DG
(Address of
principal executive office)
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
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.
|
|
|
|
|
|
|
|
|
|
|
|
Turnover
|
Q3
2024
|
|
Year
to date
|
|
£m
|
|
Growth
AER%
|
|
Growth
CER%
|
|
£m
|
|
Growth
AER%
|
|
Growth
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.
|
|
|
|
|
|
|
|
|
|
|
|
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
and joint ventures
|
(1)
|
|
|
|
|
|
(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
interests
|
157
|
|
|
|
|
|
481
|
|
|
|
|
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
&
development
|
Total
|
1,459
|
(7%)
|
(5%)
|
|
4,370
|
5%
|
7%
|
% 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
income/(expense)
|
Total
|
(335)
|
9%
|
9%
|
|
(1,186)
|
>(100%)
|
>(100%)
|
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
interests
("NCIs")
|
Total
|
123
|
76%
|
84%
|
|
289
|
(13%)
|
(5%)
|
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
flow
|
|
Q3
2024
£m
|
|
Q3
2023
£m
|
|
9
months 2024
£m
|
|
9
months 2023
£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
|
GSK plc
(LSE/NYSE:GSK) is a global biopharma company with a purpose to
unite science, technology, and talent to get ahead of disease
together. Find out more at
www.gsk.com.
|
|
|
|
|
GSK
enquiries:
|
|
|
|
Media
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington)
|
|
|
|
|
Investor
Relations
|
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 18+
|
Positive phase
IIIb, IIb data readout
|
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)
|
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(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(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(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(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(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(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(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.
|
|
|
|
External
benchmark
|
Current
score/ranking
|
Previous
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
|
(2)
|
https://unitingtocombatntds.org/en/news-and-views/zanzibar-marks-historic-milestone-with-12-billionth-medicine-dose-in-fight-against-ntds
|
(3)
|
https://gardp.org/funders-invest-an-unprecedented-eur-60-million-in-innovative-antibiotic-rd-and-access-partnership
|
(4)
|
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
|
(6)
|
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
results
£m
|
|
Intangible
amort-
isation
£m
|
|
Intangible
impair-
ment
£m
|
|
Major
restruct-
uring
£m
|
|
Trans-
action-
related
£m
|
|
Significant
legal,
Divest-
ments
and
other
items
£m
|
|
Core
results
£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
and joint ventures
|
(1)
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
interests
|
123
|
|
|
|
|
|
|
|
34
|
|
|
|
157
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
results
£m
|
|
Intangible
amort-
isation
£m
|
|
Intangible
impair-
ment
£m
|
|
Major
restruct-
uring
£m
|
|
Trans-
action-
related
£m
|
|
Significant
legal,
Divest-
ments
and
other
items
£m
|
|
Core
results
£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
interests
|
70
|
|
|
|
|
|
|
|
99
|
|
|
|
169
|
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
£m
|
|
Non-
cash
£m
|
|
Total
£m
|
|
Cash
£m
|
|
Non-
cash
£m
|
|
Total
£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
£m
|
|
Q3
2023
£m
|
Contingent
consideration on former Shionogi-ViiV Healthcare joint
Venture
(including Shionogi preferential dividends)
|
292
|
|
479
|
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
results
£m
|
|
Intangible
amort-
isation
£m
|
|
Intangible
impair-
ment
£m
|
|
Major
restruct-
uring
£m
|
|
Trans-
action-
related
£m
|
|
Significant
legal,
Divest-
ments
and
other
items
£m
|
|
Core
results
£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
and joint venture
|
(3)
|
|
|
|
|
|
|
|
|
|
|
|
(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
interests
|
289
|
|
|
|
|
|
|
|
192
|
|
|
|
481
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
results
£m
|
|
Intangible
amort-
isation
£m
|
|
Intangible
impair-
ment
£m
|
|
Major
restruct-
uring
£m
|
|
Trans-
action-
related
£m
|
|
Significant
legal,
Divest-
ments
and
other
items
£m
|
|
Core
results
£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
associates and joint ventures
|
(4)
|
|
|
|
|
|
|
|
|
|
|
|
(4)
|
Profit/(loss) on
disposal of interest in
associates
|
1
|
|
|
|
|
|
|
|
|
|
(1)
|
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
interests
|
332
|
|
|
|
|
|
|
|
88
|
|
|
|
420
|
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
£m
|
|
Non-
cash
£m
|
|
Total
£m
|
|
Cash
£m
|
|
Non-
cash
£m
|
|
Total
£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
£m
|
|
9
months 2023
£m
|
|
|
|
|
Contingent
consideration on former Shionogi-ViiV Healthcare joint
Venture
(including Shionogi preferential dividends)
|
1,106
|
|
406
|
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
£m
|
|
Q3
2023
£m
|
|
9
months 2024
£m
|
|
9
months 2023
£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
ventures
|
–
|
|
–
|
|
–
|
|
1
|
|
|
|
|
|
|
|
|
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
£m
|
|
Q3
2023
£m
|
|
9
months 2024
£m
|
|
9
months 2023
£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
investment hedges
|
164
|
|
(94)
|
|
(47)
|
|
(87)
|
Reclassification of
exchange movements on liquidation or
disposal of overseas subsidiaries and associates
|
(57)
|
|
(7)
|
|
(56)
|
|
(20)
|
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
non-controlling interests
|
(24)
|
|
5
|
|
(17)
|
|
(17)
|
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
plans
|
(45)
|
|
63
|
|
(87)
|
|
55
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
30
September 2024
£m
|
|
31
December 2023
£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
capital
£m
|
|
Share
premium
£m
|
|
Retained
earnings
£m
|
|
Other
reserves
£m
|
|
Share-
holder’s
equity
£m
|
|
Non-
controlling
interests
£m
|
|
Total
equity
£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
income/(expense) for the period
|
|
|
|
|
146
|
|
(66)
|
|
80
|
|
(17)
|
|
63
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
comprehensive income/(expense)
for the period
|
|
|
|
|
2,307
|
|
(66)
|
|
2,241
|
|
272
|
|
2,513
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributions to
non-controlling interests
|
|
|
|
|
|
|
|
|
|
|
(288)
|
|
(288)
|
Dividends to
shareholders
|
|
|
|
|
(1,832)
|
|
|
|
(1,832)
|
|
|
|
(1,832)
|
Realised after tax
losses on disposal
or liquidation of equity investments
|
|
|
|
|
15
|
|
(15)
|
|
|
|
|
|
–
|
Share
of associates and joint ventures
realised profit/(loss) on disposal of
equity investments
|
|
|
|
|
52
|
|
(52)
|
|
|
|
|
|
–
|
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
capital
£m
|
|
Share
premium
£m
|
|
Retained
earnings
£m
|
|
Other
reserves
£m
|
|
Share-
holder’s
equity
£m
|
|
Non-
controlling
interests
£m
|
|
Total
equity
£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
income/(expense) for the period
|
|
|
|
|
(279)
|
|
(343)
|
|
(622)
|
|
(17)
|
|
(639)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
comprehensive income/(expense)
for the period
|
|
|
|
|
4,299
|
|
(343)
|
|
3,956
|
|
315
|
|
4,271
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributions to
non-controlling interests
|
|
|
|
|
|
|
|
|
|
|
(334)
|
|
(334)
|
Contributions from
non-controlling
interests
|
|
|
|
|
|
|
|
|
|
|
7
|
|
7
|
Dividends to
shareholders
|
|
|
|
|
(1,679)
|
|
|
|
(1,679)
|
|
|
|
(1,679)
|
Realised after tax
losses on disposal or
liquidation of equity investments
|
|
|
|
|
(33)
|
|
33
|
|
|
|
|
|
–
|
Share
of associates and joint ventures
realised profit/(loss) on disposal of
equity investments
|
|
|
|
|
2
|
|
(2)
|
|
|
|
|
|
–
|
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
transferred to non-financial assets
|
|
|
|
|
|
|
32
|
|
32
|
|
|
|
32
|
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
£m
|
|
9
months 2023
£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 consideration
paid)
|
2,404
|
|
94
|
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,
Varilrix
|
83
|
|
1
|
|
4
|
|
12
|
|
>100
|
|
>100
|
|
32
|
|
(9)
|
|
(6)
|
|
39
|
|
(9)
|
|
(5)
|
Cervarix
|
18
|
|
(42)
|
|
(42)
|
|
–
|
|
–
|
|
–
|
|
4
|
|
100
|
|
100
|
|
14
|
|
(52)
|
|
(52)
|
Other
|
71
|
|
39
|
|
41
|
|
3
|
|
(40)
|
|
–
|
|
9
|
|
>100
|
|
>100
|
|
59
|
|
34
|
|
34
|
Vaccines
excluding
COVID-19 solutions
|
2,650
|
|
(18)
|
|
(15)
|
|
1,458
|
|
(29)
|
|
(26)
|
|
522
|
|
(1)
|
|
1
|
|
670
|
|
4
|
|
10
|
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,
Varilrix
|
240
|
|
27
|
|
31
|
|
26
|
|
>100
|
|
>100
|
|
93
|
|
(5)
|
|
(3)
|
|
121
|
|
51
|
|
58
|
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
COVID-19 solutions
|
6,926
|
|
(3)
|
|
–
|
|
3,301
|
|
(16)
|
|
(13)
|
|
1,568
|
|
(1)
|
|
1
|
|
2,057
|
|
27
|
|
33
|
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
and Other
|
843
|
|
10
|
|
14
|
|
555
|
|
5
|
|
9
|
|
139
|
|
17
|
|
20
|
|
149
|
|
22
|
|
29
|
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
excluding COVID-19
solutions
|
2,966
|
|
14
|
|
19
|
|
1,991
|
|
15
|
|
20
|
|
590
|
|
10
|
|
12
|
|
385
|
|
17
|
|
23
|
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
and Other
|
2,389
|
|
10
|
|
15
|
|
1,570
|
|
6
|
|
10
|
|
409
|
|
19
|
|
22
|
|
410
|
|
19
|
|
29
|
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
excluding COVID-19
solutions
|
8,511
|
|
16
|
|
20
|
|
5,665
|
|
19
|
|
22
|
|
1,767
|
|
10
|
|
12
|
|
1,079
|
|
15
|
|
22
|
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
£m
|
|
Q3
2023
£m
|
|
Growth
£%
|
|
Growth
CER%
|
|
|
|
|
|
|
|
|
Commercial
Operations (total turnover)
|
8,012
|
|
8,147
|
|
(2)
|
|
2
|
|
|
|
|
|
|
|
|
Operating
profit by segment
|
|
Q3
2024
£m
|
|
Q3
2023
£m
|
|
Growth
£%
|
|
Growth
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
joint ventures
|
(1)
|
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
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
£m
|
|
9
months 2023
£m
|
|
Growth
£%
|
|
Growth
CER%
|
|
|
|
|
|
|
|
|
Commercial
Operations (total turnover)
|
23,259
|
|
22,276
|
|
4
|
|
8
|
|
|
|
|
|
|
|
|
Operating
profit by segment
|
|
9
months 2024
£m
|
|
9
months 2023
£m
|
|
Growth
£%
|
|
Growth
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
and joint ventures
|
(3)
|
|
(4)
|
|
|
|
|
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/
Payable
|
|
Pence
per
share
|
|
£m
|
|
|
|
|
|
|
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
millions
|
|
Q3
2023
millions
|
|
9
months 2024
millions
|
|
9
months 2023
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
Healthcare
£m
|
|
Group
£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
Healthcare
£m
|
|
Group
£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.
Reconciliation
of cash flow to movements in net debt
|
|
|
|
|
|
9
months 2024
£m
|
|
9
months 2023
£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)
|
|
30
September 2024
£m
|
|
31
December 2023
£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
£m
|
|
Q3
2023
£m
|
|
9
months 2024
£m
|
|
9
months 2023
£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.
Medicines and
vaccines in phase III development (including major lifecycle
innovation or under regulatory review)
|
18
|
Infectious
Diseases (7)
|
●
|
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
indications)
|
88
|
|
|
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
(Adults
≥ 60 years old)
NCT04732871
|
III
|
A
randomised, open-label, multi-country trial to evaluate the
immunogenicity, safety, reactogenicity and persistence of a single
dose of the RSVPreF3 OA investigational vaccine and different
revaccination schedules in adults aged 60 years and
above
|
Trial
start:
Q1
2021
Primary
data reported:
Q2
2022
|
Active,
not recruiting; primary endpoint met
|
RSV
OA=ADJ-006
(ARESVI-006; Adults
≥ 60 years old)
NCT04886596
|
III
|
A
randomised, placebo-controlled, observer-blind, multi-country trial
to demonstrate the efficacy of a single dose of GSK’s
RSVPreF3 OA investigational vaccine in adults aged 60 years and
above
|
Trial
start:
Q2
2021
Primary
data reported:
Q2
2022;
two
season data reported:
Q2
2023;
three
season data reported: Q3 2024
|
Complete; primary
endpoint met
|
RSV
OA=ADJ-007
(Adults
≥ 60 years old)
NCT04841577
|
III
|
An
open-label, randomised, controlled, multi-country trial to evaluate
the immune response, safety and reactogenicity of RSVPreF3 OA
investigational vaccine when co-administered with FLU-QIV vaccine
in adults aged 60 years and above
|
Trial
start:
Q2
2021
Primary
data reported:
Q4
2022
|
Complete; primary
endpoint met
|
RSV
OA=ADJ-008
(Adults
≥ 65 years old)
NCT05559476
|
III
|
A phase
III, open-label, randomised, controlled, multi country trial to
evaluate the immune response, safety and reactogenicity of RSVPreF3
OA investigational vaccine when co-administered with FLU HD vaccine
in adults aged 65 years and above
|
Trial
start:
Q4
2022
Primary
data reported:
Q2
2023
|
Complete; primary
endpoint met
|
RSV
OA=ADJ-009
(Adults
≥ 60 years old)
NCT05059301
|
III
|
A
randomised, double-blind, multi-country trial to evaluate
consistency, safety, and reactogenicity of 3 lots of RSVPreF3 OA
investigational vaccine administrated as a single dose in adults
aged 60 years and above
|
Trial
start:
Q4
2021
Trial
end:
Q2
2022
|
Complete; primary
endpoint met
|
RSV
OA=ADJ-017
(Adults
≥ 65 years old)
NCT05568797
|
III
|
A phase
III, open-label, randomised, controlled, multi-country trial to
evaluate the immune response, safety and reactogenicity of an
RSVPreF3 OA investigational vaccine when co-administered with FLU
aQIV (inactivated influenza vaccine – adjuvanted) in adults
aged 65 years and above
|
Trial
start:
Q4
2022
Primary
data reported:
Q2
2023
|
Complete; data
analysis ongoing
|
Key
phase III trials for Arexvy
(continued):
|
|
|
|
|
Trial
name (population)
|
Phase
|
Design
|
Timeline
|
Status
|
RSV
OA=ADJ-018
(Adults
50-59 years)
NCT05590403
|
III
|
A phase
III, observer-blind, randomised, placebo-controlled trial to
evaluate the non-inferiority of the immune response and safety of
the RSVPreF3 OA investigational vaccine in adults 50-59 years of
age, including adults at increased risk of respiratory syncytial
virus lower respiratory tract disease, compared to older adults
≥60 years of age
|
Trial
start:
Q4
2022
Primary
data reported:
Q4
2023
|
Complete; primary
endpoint met
|
RSV
OA=ADJ-019
(Adults
≥ 60 years old)
NCT05879107
|
III
|
An
open-label, randomised, controlled, multi-country trial to evaluate
the immune response, safety and reactogenicity of RSVPreF3 OA
investigational vaccine when co-administered with PCV20 in adults
aged 60 years and older
|
Trial
start:
Q2
2023
Data
anticipated:
H2
2024
|
Complete
|
RSV
OA=ADJ-023
(Immunocompromised
Adults 50-59 years)
NCT05921903
|
IIb
|
A
randomised, controlled, open-label trial to evaluate the immune
response and safety of the RSVPreF3 OA investigational vaccine in
adults (≥50 years of age) when administered to lung and renal
transplant recipients comparing one versus two doses and compared
to healthy controls (≥50 years of age) receiving one
dose
|
Trial
start:
Q3
2023
Primary
data reported:
Q4
2024
|
Active,
not recruiting; primary endpoint met
|
RSV-OA=ADJ-020
(Adults
aged >=50 years of age)
NCT05966090
|
III
|
A study
on the safety and immune response of investigational RSV OA vaccine
in combination with herpes zoster vaccine in healthy
adults
|
Trial
start:
Q3
2023
Primary
data reported:
Q3
2024
|
Active,
not recruiting; primary endpoint met
|
RSV-OA=ADJ-013
(Adults
aged 50 years and above)
NCT06374394
|
III
|
An
open-label, randomized, controlled study to evaluate the immune
response, safety and reactogenicity of RSVPreF3 OA investigational
vaccine when co-administered with a COVID-19 mRNA
vaccine
|
Trial
start:
Q2
2024
Data
anticipated:
H2
2024
|
Active,
not recruiting
|
RSV
OA=ADJ-025
(Adults, 18-49
years of age, at increased risk for RSV disease and older adults
participants, >=60 YOA)
NCT06389487
|
IIIb
|
An
open-label study to evaluate the non-inferiority of the immune
response and to evaluate the safety of the RSVPreF3 OA
investigational vaccine in adults 18-49 years of age at increased
risk for Respiratory Syncytial Virus disease, compared to older
adults >=60 years of age
|
Trial
start:
Q2
2024
Primary
data reported:
Q4
2024
|
Active,
not recruiting; primary endpoint met
|
RSV
OA=ADJ-021
(Adults
aged 60 years and above)
NCT06551181
|
III
|
A study
on the immune response, safety and the occurrence of Respiratory
Syncytial Virus (RSV)-associated respiratory tract illness after
administration of RSV OA vaccine in adults 60 years and
older
|
Trial
start:
Q3
2024
Data
anticipated:
H2
2025
|
Recruiting
|
RSV
OA+ADJ-012
(Adults
aged 60 years and above)
NCT06534892
|
|
An
Extension and Crossover Vaccination Study on the Immune Response
and Safety of a Vaccine Against Respiratory Syncytial Virus Given
to Adults 60 Years of Age and Above Who Participated in RSV
OA=ADJ-006 Study
|
Trial
start: Q3 2024
Data
anticipated: 2026
|
Recruiting
|
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)
NCT05630807
|
III
|
A
multi-centre, randomised, double-blind, placebo-controlled trial to
confirm the efficacy and safety of treatment with bepirovirsen in
participants with chronic hepatitis B virus
|
Trial
Start:
Q1
2023
Data
anticipated: 2026+
|
Active,
not recruiting
|
B-Well
2 bepirovirsen in nucleos(t)ide treated patients (chronic hepatitis
B)
NCT05630820
|
III
|
A
multi-centre, randomised, double-blind, placebo-controlled trial to
confirm the efficacy and safety of treatment with bepirovirsen in
participants with chronic hepatitis B virus
|
Trial
Start:
Q1
2023
Data
anticipated: 2026+
|
Active,
not recruiting
|
bepirovirsen
sequential combination therapy with targeted
immunotherapy
(chronic hepatitis
B)
NCT05276297
|
II
|
A trial
on the safety, efficacy and immune response following sequential
treatment with an anti-sense oligonucleotide against chronic
hepatitis B (CHB) and chronic hepatitis B targeted immunotherapy
(CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA)
therapy
|
Trial
start:
Q2
2022
Data
anticipated: 2026+
|
Active,
not recruiting
|
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)
NCT04010539
|
III
|
A
randomised, multi-centre, open-label trial in adolescent and adult
participants comparing the efficacy and safety of gepotidacin to
ceftriaxone plus azithromycin in the treatment of uncomplicated
urogenital gonorrhoea caused by Neisseria gonorrhoeae
|
Trial
start:
Q4
2019
Data
reported:
Q1
2024
|
Complete;
primary
endpoint met
|
EAGLE-2
(females with uUTI / acute cystitis)
NCT04020341
|
III
|
A
randomised, multi-centre, parallel-group, double-blind,
double-dummy trial in adolescent and adult female participants
comparing the efficacy and safety of gepotidacin to nitrofurantoin
in the treatment of uncomplicated urinary tract infection (acute
cystitis)
|
Trial
start:
Q4
2019
Data
reported:
Q2
2023
|
Complete; primary
endpoint met
|
EAGLE-3
(females with uUTI / acute cystitis)
NCT04187144
|
III
|
A
randomised, multi-centre, parallel-group, double-blind,
double-dummy trial in adolescent and adult female participants
comparing the efficacy and safety of gepotidacin to nitrofurantoin
in the treatment of uncomplicated urinary tract infection (acute
cystitis)
|
Trial
start:
Q2
2020
Data
reported:
Q2
2023
|
Complete; primary
endpoint met
|
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
NCT04707391
|
IIIb
|
A
randomised, controlled, observer-blind trial to evaluate safety and
immunogenicity of GSK’s meningococcal ABCWY vaccine when
administered in healthy adolescents and adults, previously primed
with meningococcal ACWY vaccine
|
Trial
start:
Q1
2021
Data
reported:
Q1
2024
|
Complete, primary
endpoints met
|
MenABCWY –
V72 72
NCT04502693
|
III
|
A
randomised, controlled, observer-blind trial to demonstrate
effectiveness, immunogenicity, and safety of GSK's meningococcal
Group B and combined ABCWY vaccines when administered to healthy
adolescents and young adults
|
Trial
start:
Q3
2020
Data
reported:
Q1
2023
|
Complete; primary
endpoints met
|
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)
NCT05599191
|
III
|
A
52-week, randomised, double-blind, placebo-controlled, parallel-arm
efficacy and safety trial with open-label extension of camlipixant
in adult participants with refractory chronic cough, including
unexplained chronic cough
|
Trial
start:
Q4
2022
Data
anticipated:
H2
2025
|
Recruiting
|
CALM-2
(refractory chronic cough)
NCT05600777
|
III
|
A
24-week, randomised, double-blind, placebo-controlled, parallel-arm
efficacy and safety trial with open-label extension of camlipixant
in adult participants with refractory chronic cough, including
unexplained chronic cough
|
Trial
start:
Q1
2023
Data
anticipated:
H2
2025
|
Recruiting
|
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)
NCT04719832
|
III
|
A
52-week, randomised, double-blind, placebo-controlled,
parallel-group, multi-centre trial of the efficacy and safety of
depemokimab adjunctive therapy in adult and adolescent participants
with severe uncontrolled asthma with an eosinophilic
phenotype
|
Trial
start:
Q1
2021
Data
reported:
Q2
2024
|
Complete; primary
endpoint met
|
SWIFT-2
(severe eosinophilic asthma)
NCT04718103
|
III
|
A
52-week, randomised, double-blind, placebo-controlled,
parallel-group, multi-centre trial of the efficacy and safety of
depemokimab adjunctive therapy in adult and adolescent participants
with severe uncontrolled asthma with an eosinophilic
phenotype
|
Trial
start:
Q1
2021
Data
reported:
Q2
2024
|
Complete; primary
endpoint met
|
AGILE
(SEA)
NCT05243680
|
III
(exten
sion)
|
A
52-week, open label extension phase of SWIFT-1 and SWIFT-2 to
assess the long-term safety and efficacy of depemokimab adjunctive
therapy in adult and adolescent participants with severe
uncontrolled asthma with an eosinophilic phenotype
|
Trial
start:
Q1
2022
Data
anticipated:
H1
2025
|
Active,
not recruiting
|
NIMBLE
(SEA)
NCT04718389
|
III
|
A
52-week, randomised, double-blind, double-dummy, parallel group,
multi-centre, non-inferiority trial assessing exacerbation rate,
additional measures of asthma control and safety in adult and
adolescent severe asthmatic participants with an eosinophilic
phenotype treated with depemokimab compared with mepolizumab or
benralizumab
|
Trial
start:
Q1
2021
Data
anticipated:
H2
2025
|
Active,
not recruiting
|
ANCHOR-1 (chronic
rhinosinusitis with nasal polyps; CRSwNP)
NCT05274750
|
III
|
Efficacy and safety
of depemokimab in participants with CRSwNP
|
Trial
start:
Q2
2022
Data
reported: Q3 2024
|
Complete; primary
endpoint met
|
ANCHOR-2
(CRSwNP)
NCT05281523
|
III
|
Efficacy and safety
of depemokimab in participants with CRSwNP
|
Trial
start:
Q2
2022
Data
reported:
Q3
2024
|
Complete; primary
endpoint met
|
OCEAN
(eosinophilic granulomatosis with polyangiitis; EGPA)
NCT05263934
|
III
|
Efficacy and safety
of depemokimab compared with mepolizumab in adults with relapsing
or refractory EGPA
|
Trial
start:
Q3
2022
Data
anticipated:
2026+
|
Recruiting
|
DESTINY
(hyper-eosinophilic syndrome; HES)
NCT05334368
|
III
|
A
52-week, randomised, placebo-controlled, double-blind, parallel
group, multicentre trial of depemokimab in adults with uncontrolled
HES receiving standard of care (SoC) therapy
|
Trial
start:
Q3
2022
Data
anticipated:
2026+
|
Recruiting
|
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)
NCT04133909
|
III
|
A
multicentre randomised, double-blind, parallel-group,
placebo-controlled trial of mepolizumab 100 mg subcutaneously as
add-on treatment in participants with COPD experiencing frequent
exacerbations and characterised by eosinophil levels
|
Trial
start:
Q4
2019
Data
reported:
Q3
2024
|
Active,
not recruiting; primary endpoint met
|
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)
NCT04246047
|
III
|
A
multi-centre, open-label, randomised trial to evaluate the efficacy
and safety of the combination of belantamab mafodotin, bortezomib,
and dexamethasone (B-Vd) compared with the combination of
daratumumab, bortezomib and dexamethasone (D-Vd) in participants
with relapsed/refractory multiple myeloma
|
Trial
start:
Q2
2020
Primary
data reported:
Q4 2023
|
Primary
endpoint met
|
DREAMM-8 (2L+
MM)
NCT04484623
|
III
|
A
multi-centre, open-label, randomised trial to evaluate the efficacy
and safety of belantamab mafodotin in combination with pomalidomide
and dexamethasone (B-Pd) versus pomalidomide plus bortezomib and
dexamethasone (P-Vd) in participants with relapsed/refractory
multiple myeloma
|
Trial
start:
Q4
2020
Primary
data reported:
Q1
2024
|
Primary
endpoint met
|
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)
NCT03981796
|
III
|
A
randomised, double-blind, multi-centre trial of dostarlimab plus
carboplatin-paclitaxel with and without niraparib maintenance
versus placebo plus carboplatin-paclitaxel in patients with
recurrent or primary advanced endometrial cancer
|
Trial
start:
Q3
2019
Part 1
data reported:
Q4
2022
Part 2
data reported:
Q4
2023
|
Active,
not recruiting; primary endpoints met
|
PERLA
(1L metastatic non-small cell lung cancer)
NCT04581824
|
II
|
A
randomised, double-blind trial to evaluate the efficacy of
dostarlimab plus chemotherapy versus pembrolizumab plus
chemotherapy in metastatic non-squamous non-small cell lung
cancer
|
Trial
start:
Q4
2020
Primary
data reported:
Q4
2022
|
Active,
not recruiting; primary endpoint met
|
GARNET
(advanced solid tumours)
NCT02715284
|
I/II
|
A
multi-centre, open-label, first-in-human trial evaluating
dostarlimab in participants with advanced solid tumours who have
limited available treatment options
|
Trial
start:
Q1
2016
Primary
data reported:
Q1
2019
|
Recruiting
|
AZUR-1
(locally advanced rectal cancer)
NCT05723562
|
II
|
A
single-arm, open-label trial with dostarlimab monotherapy in
participants with untreated stage II/III dMMR/MSI-H locally
advanced rectal cancer
|
Trial
start:
Q1
2023
Data
anticipated: 2026+
|
Active,
not recruiting
|
AZUR-2
(untreated perioperative T4N0 or stage III colon
cancer)
NCT05855200
|
III
|
An
open-label, randomised trial of perioperative dostarlimab
monotherapy versus standard of care in participants with untreated
T4N0 or stage III dMMR/MSI-H resectable colon cancer
|
Trial
start:
Q3
2023
Data
anticipated: 2026+
|
Recruiting
|
COSTAR
Lung (advanced non-small cell lung cancer that has progressed on
prior PD-(L)1 therapy and chemotherapy)
NCT04655976
|
II/III
|
A
multi-centre, randomised, parallel group treatment, open label
trial comparing cobolimab + dostarlimab + docetaxel to dostarlimab
+ docetaxel to docetaxel alone in participants with advanced
non-small cell lung cancer who have progressed on prior
anti-PD-(L)1 therapy and chemotherapy
|
Trial
start:
Q4
2020
Data
anticipated:
H1
2025
|
Active,
not recruiting
|
JADE
(locally advanced unresected head and neck cancer)
NCT06256588
|
III
|
A
randomised, double-blind, study to evaluate dostarlimab versus
placebo as sequential therapy after chemoradiation in participants
with locally advanced unresected head and neck squamous cell
carcinoma
|
Trial
start:
Q1
2024
Data
anticipated: 2026+
|
Recruiting
|
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)
NCT04475939
|
III
|
A
randomised, double-blind, placebo-controlled, multi-centre trial
comparing niraparib plus pembrolizumab versus placebo plus
pembrolizumab as maintenance therapy in participants whose disease
has remained stable or responded to first-line platinum-based
chemotherapy with pembrolizumab for Stage IIIB/IIIC or IV non-small
cell lung cancer
|
Trial
start:
Q4
2020
Data
anticipated:
H2
2024
|
Active,
not recruiting
|
FIRST
(1L ovarian cancer maintenance)
NCT03602859
|
III
|
A
randomised, double-blind, comparison of platinum-based therapy with
dostarlimab (TSR-042) and niraparib versus standard of care
platinum-based therapy as first-line treatment of stage III or IV
non-mucinous epithelial ovarian cancer
|
Trial
start:
Q4
2018
Data
anticipated:
H2
2024
|
Active,
not recruiting
|
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:
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the
income statement and statement of comprehensive income for the
three and nine month periods ended 30 September 2024 on page 26 and
27;
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the
balance sheet as at 30 September 2024 on page 28;
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the
statement of changes in equity for the nine-month period then ended
on page 29;
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the
cash flow statement for the nine-month period then ended on page
30; and
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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.
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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
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorised.
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GSK
plc
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(Registrant)
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Date: October
30, 2024
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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