|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash generated from
operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q3 2024
|
|
Year to date
|
|
|
£m
|
|
|
|
|
|
£m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q3 2024
|
|
Year to date
|
|
|
£m
|
|
% AER
|
|
% CER
|
|
£m
|
|
% AER
|
|
% CER
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
|
|
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:
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other operating
income/(expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating profit
|
6,172
|
|
535
|
|
149
|
|
264
|
|
117
|
|
(203)
|
|
7,034
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share of after tax profit/(loss)
of
associates and joint
ventures
|
(4)
|
|
|
|
|
|
|
|
|
|
|
|
(4)
|
|
Profit/(loss) on disposal of
interest in
associates
|
1
|
|
|
|
|
|
|
|
|
|
(1)
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments in associates and joint
ventures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative instruments
|
4
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets
|
40,751
|
|
40,361
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade and other
receivables
|
|
|
|
Derivative financial
instruments
|
|
|
|
Current equity
investments
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
17,298
|
|
18,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration
liabilities
|
|
|
|
|
|
|
|
|
Derivative financial
instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
(21,459)
|
|
(21,068)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pensions and other post-employment
benefits
|
|
|
|
|
|
|
|
|
Contingent consideration
liabilities
|
|
|
|
Other non-current
liabilities
|
|
|
|
|
|
|
|
|
|
Total non-current
liabilities
|
(23,137)
|
|
(25,142)
|
|
|
|
|
|
|
TOTAL LIABILITIES
|
(44,596)
|
|
(46,210)
|
|
|
|
|
|
|
NET ASSETS
|
13,453
|
|
12,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-controlling
interests
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
Share of after tax loss/(profit) of
associates and joint ventures
|
|
|
|
(Profit)/loss on disposal of
interest in associates and joint ventures
|
|
|
|
|
|
|
|
|
Depreciation, amortisation and
other adjusting items
|
|
|
|
(Increase)/decrease in working
capital
|
|
|
|
Contingent consideration
paid
|
|
|
|
Increase/(decrease) in other net
liabilities (excluding contingent consideration paid)
|
|
|
|
|
Cash generated from
operations
|
5,275
|
|
4,415
|
|
|
|
|
|
|
Total net cash inflow/(outflow)
from operating activities
|
4,225
|
|
3,572
|
|
|
|
|
|
|
Cash flow from investing
activities
|
|
|
|
Purchase of property, plant and
equipment
|
|
|
|
Proceeds from sale of property,
plant and equipment
|
|
|
|
Purchase of intangible
assets
|
|
|
|
Proceeds from sale of intangible
assets
|
|
|
|
Purchase of equity
investments
|
|
|
|
Proceeds from sale of equity
investments
|
|
|
|
Purchase of businesses, net of cash
acquired
|
|
|
|
|
Investment in joint ventures and
associates
|
(42)
|
|
-
|
Contingent consideration
paid
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Increase)/decrease in liquid
investments
|
|
|
|
Dividends from joint ventures and
associates
|
|
|
|
Dividend and distributions from
investments
|
|
|
|
Proceeds from disposal of
associates and Joint ventures
|
|
|
|
|
Total net cash inflow/(outflow)
from investing activities
|
(110)
|
|
(1,863)
|
|
|
|
|
|
|
Cash flow from financing
activities
|
|
|
|
|
|
|
|
|
Repayment of long-term
loans
|
|
|
|
|
|
|
|
|
Repayment of short-term
loans
|
|
|
|
Net increase/(repayment) of other
short-term loans
|
|
|
|
Repayment of lease
liabilities
|
|
|
|
|
|
|
|
|
Dividends paid to
shareholders
|
|
|
|
Distribution to non-controlling
interests
|
|
|
|
Contributions from non-controlling
interests
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
£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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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