|
GSK makes a strong start to 2024
with improving outlook for the year
|
|
|
Broad-based performance drives
sales, profits and earnings growth:
|
|
Total Q1 2024 sales £7.4
billion +10% and +13% ex COVID
|
|
Vaccines sales +16%, +22% ex
COVID. Shingrix £0.9 billion +18%, Arexvy £0.2 billion
|
|
Specialty Medicines sales +17%,
+19% ex COVID with HIV +14%
|
|
General Medicines sales
+1%. Trelegy £0.6 billion +33%
|
•
|
Total operating profit and Total
EPS for Q1 2024 reflected higher charges for CCL(2) remeasurement, partly offset by
strong Core(1) growth
|
•
|
Core operating profit +27% (with
further positive impact of +8% ex COVID) and Core EPS +28% (with
further positive impact of +9% ex COVID). This reflected strong
sales and SG&A leverage, partly offset by increased investment
in R&D and lower royalty income
|
|
Cash generated from operations
exceeded £1 billion with free cash flow of £0.3 billion
|
(Financial Performance - Q1 2024
results unless otherwise stated, growth % and commentary at CER, ex
COVID is excluding COVID-19 solutions as defined on page
47).
|
|
|
Q1 2024
|
|
£m
|
|
% AER
|
|
% CER
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash generated from
operations
|
|
|
|
|
|
|
|
R&D delivery and targeted
business development supports future growth:
|
•
|
Strong pipeline progress with
positive phase III read outs for gepotidacin in uncomplicated
urogenital gonorrhoea, Cabenuva
in HIV treatment, Jemperli in endometrial cancer,
and Blenrep in
multiple myeloma
|
•
|
Innovative Vaccine portfolio
further strengthened with regulatory submission acceptances
for Arexvy for
prevention of RSV in adults 50-59 (US), new meningococcal ABCWY
vaccine candidate (US), and Shingrix for prevention of shingles
in at-risk adults >18 (China)
|
|
US FDA Fast Track designation
received for bepirovirsen in chronic hepatitis B
|
•
|
New positive data for CAB-ULA as
ultra long-acting treatment for HIV supports progression and
transition of HIV portfolio for long-term growth
|
•
|
US FDA regulatory submission
accepted for priority review for Jemperli to treat endometrial cancer
in broader patient populations
|
•
|
Acquisition of Aiolos Bio completed,
expanding respiratory biologics pipeline with AIO-001, a
potentially best-in-class long-acting TSLP monoclonal antibody for
treatment of asthma
|
|
|
2024 guidance updated and
dividends:
|
•
|
Now expect 2024 turnover growth
towards the upper part of 5% to 7% range; Core operating profit
growth of 9% to 11% (previously 7% to 10%); Core EPS growth of 8%
to 10% (previously 6% to 9%)
|
|
Dividend declared of 15p for Q1
2024; 60p expected for Full Year 2024
|
Guidance all at CER and excluding
COVID-19 solutions
|
Emma Walmsley, Chief Executive
Officer, GSK:
"We have made a strong start to
2024, with another quarter of excellent performance and continued
pipeline progress, including positive data read outs for 4 phase
III medicines. These, together with other R&D achievements,
mean we have strengthened prospects for growth in all of our key
therapeutic areas this quarter: infectious diseases, HIV,
respiratory/immunology and oncology. We expect this strong momentum
to continue, and look forward to delivering another year of
meaningful growth in sales and earnings in 2024."
|
The Total results are presented in
summary above and on page 8 and Core results reconciliations are
presented on pages 20 and 21. (1) GSK has made an update to its
reporting framework in Q1 2024 which is to change the description
of Adjusted results to Core results to align with European peers in
the pharmaceutical industry but with no change to the basis or
figures. 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 47: 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 49. (2)
Contingent consideration liability is abbreviated to
CCL.
2024 Guidance
GSK provides its full-year
guidance at constant exchange rates (CER). All expectations and
full-year growth rates exclude any contributions from COVID-19
solutions.
GSK has started 2024 strongly,
with business momentum across all product areas, particularly in
Vaccines and Specialty Medicines, including sales contributions
from newly launched vaccines and medicines Arexvy and Ojjaara respectively. General
Medicines, particularly Trelegy,
also performed better than expected. Along with a
favourable product mix, GSK benefitted in the quarter from a
successful Zejula royalty dispute appeal, and we also expect royalty income to
be slightly higher for the full year. As a result, GSK has upgraded
its full-year 2024 guidance.
|
|
|
All Guidance excludes the
contributions of COVID-19 solutions
|
Current 2024 guidance at
CER
|
Previous 2024 guidance at
CER
|
Turnover
|
Increase towards the upper part of
the range of between 5% to 7%
|
Increase between 5% to 7%
|
Core operating profit
|
Increase between 9% to
11%
|
Increase between 7% to
10%
|
Core earnings per share
|
Increase between 8% to
10%
|
Increase between 6% to 9%
|
GSK expects first half 2024 sales
growth to be higher than second half 2024 due to the comparator to
H2 2023, which benefitted from newly launched vaccines and
medicines. In particular, second half 2024, compared to the same
period in the prior year, is expected to be influenced by the 2023
launch dynamics and initial channel inventory build attributable
to Arexvy. In
addition, we expect the majority of Shingrix sales in China in to be in
the first half 2024.
This guidance continues to be
supported by the following turnover expectations for full-year 2024
at CER:
|
|
All turnover expectations exclude
the contributions of COVID-19 solutions
|
No change to current 2024
expectations at CER
|
Vaccines
|
Increase of high single-digit to low
double-digit per cent in turnover
|
Specialty Medicines
|
Increase of low double-digit per
cent in turnover
|
General Medicines
|
Decrease of mid-single-digit per
cent in turnover
|
Core Operating profit is expected
to grow between 9 to 11 per cent at CER (previously 7 to 10 per
cent increase), despite a 6 percentage point impact to Operating
Profit growth following the loss of the majority of Gardasil
royalties effective from the beginning of 2024. GSK continues to
expect to deliver leverage at a gross margin level due to improved
product mix from Vaccines and Specialty Medicines growth and
continued operational efficiencies. In addition, GSK continues to
anticipate further leverage in Operating Profit due to a step down
in SG&A growth to a low single-digit increase. R&D
continues to be expected to increase broadly in line with sales to
support growth of the pipeline.
Core Earnings per share is now
expected to increase between 8 to 10 per cent at CER, reflecting
higher operating profit and more favourable net finance costs.
Expectations for non-controlling interests remain unchanged
relative to 2023, and GSK continues to anticipate an increase in
the Core effective tax rate to around 17% following implementation
of a global minimum corporate income tax rate aligned with the
Organisation for Economic Co-Operation and Development 'Pillar 2'
initiative.
2021-26 and 2031
Outlooks
In January 2024 GSK set out
improved outlooks for the period 2021-2026 and for 2031. Please see
2023 Full year and fourth quarter results on
gsk.com.
Additional commentary
Dividend policy
The Dividend policy and the
expected pay-out ratio remain unchanged. Consistent with this, and
reflecting strong business performance during the quarter, GSK
expects to declare a dividend for Q1 2024 of 15p per share and for
the full year 2024 60p.
COVID-19 solutions
For the full year 2024, GSK does
not anticipate any further COVID-19 pandemic-related sales or
operating profit. Consequently, and in comparison to 2023, it is
anticipated that the full year growth in sales and Core operating
profit will be adversely impacted by one and two percentage points,
respectively.
Exchange rates
If exchange rates were to hold at
the closing rates on 31 March 2024 ($ 1.26/£1, € 1.17/£1 and Yen
191/£1) for the rest of 2024, the estimated impact on 2024 Sterling
turnover growth for GSK would be -3% 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 -5%.
Results presentation
A conference call and webcast for
investors and analysts of the quarterly results will be hosted by
Emma Walmsley, CEO, at 12 noon BST (US EST at 7am) on 1 May
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.
|
|
|
|
|
|
|
Q1 2024
|
|
£m
|
|
Growth
AER%
|
|
Growth
CER%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
13
|
|
8
|
|
8
|
Established Vaccines
|
838
|
|
3
|
|
7
|
Vaccines ex COVID
|
2,277
|
|
17
|
|
22
|
Pandemic vaccines
|
-
|
|
>(100)
|
|
>(100)
|
Vaccines
|
2,277
|
|
12
|
|
16
|
HIV
|
1,613
|
|
10
|
|
14
|
Respiratory/Immunology and
Other
|
635
|
|
6
|
|
11
|
Oncology
|
273
|
|
>100
|
|
>100
|
Specialty Medicines ex
COVID
|
2,521
|
|
14
|
|
19
|
Xevudy
|
1
|
|
(97)
|
|
(97)
|
Specialty Medicines
|
2,522
|
|
13
|
|
17
|
|
|
|
|
|
|
|
|
|
|
|
|
General Medicines
|
2,564
|
|
(4)
|
|
1
|
Total
|
7,363
|
|
6
|
|
10
|
Total ex COVID
|
7,362
|
|
8
|
|
13
|
By Region:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
7,363
|
|
6
|
|
10
|
|
Turnover ex COVID is excluding
COVID-19 solutions during the years from 2020 to 2023 and is a
non-IFRS measure defined on page 47 with the reconciliation to the
IFRS measure Turnover included in the table above. Financial
Performance - Q1 2024 results unless otherwise stated, growth % and
commentary at CER.
|
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Vaccines
|
Total
|
2,277
|
12%
|
16%
|
Excluding COVID
|
2,277
|
17%
|
22%
|
In Q1 2024, Vaccine sales
increased by double-digits, reflecting US demand for
Arexvy and strong market
growth for Shingrix in International and European markets. However, the quarter's
growth was adversely impacted by six percentage points due to
COVID-19 solution sales compared to Q1 2023.
The sales of Shingrix, a vaccine against herpes
zoster (shingles), increased in the quarter due to strong demand
following public funding expansion in International and European
markets, with new national immunisation programmes in Australia and
Europe, including the UK, together with earlier than anticipated
supply to Zhifei (Chongqing Zhifei Biological Products, Ltd), GSK's
co-promotion partner in China. Markets outside the US now represent
more than 50% of global sales (Q1 2023: 40%), with
Shingrix launched in 39
countries. The majority of these markets have average cumulative
immunisation rates below 5%.
In Q1 2024, US sales decreased by
7% at AER and 4% at CER, reflecting the comparison to Q1 2023,
which benefitted from the removal of adult vaccine cost-sharing
covered under Medicare Part D and expanded coverage of adult
vaccines under Medicare following the implementation of the
Inflation Reduction Act. In addition, the performance reflected the
prioritisation of other adult vaccines for example, influenza and
COVID-19 during the viral respiratory season and the increasing
challenge of activating harder to reach consumers. The US
cumulative immunisation penetration rate at the end of 2023 reached
37% of the more than 120 million US adults(1) currently recommended to
receive Shingrix,
up seven percentage points since the end of 2022. The US
performance in Q1 2024 was partly offset by favourable pricing and
prior period channel inventory movements.
(1)
|
United States Census Bureau,
International Database, Year 2023.
|
|
|
|
|
|
Q1 2024
|
|
£m
|
AER
|
CER
|
Meningitis
|
299
|
7%
|
11%
|
In Q1 2024, meningitis vaccine
sales increased following higher demand in International markets
for Menveo, a
vaccine against meningitis ACWY. Sales for Bexsero, a vaccine against
meningitis B, were stable at AER and increased by 3% at CER in the
quarter, primarily reflecting increased demand in Australian
regional immunisation programmes and the recent launch in Vietnam.
However, this performance was partly offset by tender phasing in
Europe.
Arexvy, a
respiratory syncytial virus (RSV) vaccine for older adults,
delivered Q1 2024 sales of £182 million, reflecting continued
strong consumer uptake and leading market share. In the US, Q1 2024
sales were £154 million, with the overwhelming majority of doses
administered in the retail setting. Arexvy maintained around two-thirds
of the vaccination share, while demand decreased overall in line
with anticipated seasonality patterns. More than seven million of
the 83 million US adults(1)
aged 60 and older at risk have been protected
by Arexvy since
the launch in Q3 2023. The performance in Q1 2024 also reflected
initial tender deliveries in Saudi Arabia, continued consumer
uptake in Canada, and a new launch inventory build in
Brazil.
|
|
|
|
Established Vaccines
|
838
|
3%
|
7%
|
In Q1 2024, Established Vaccines'
growth was driven by an increased supply of measles, mumps,
rubella, and varicella vaccines in International, a higher share
of Rotarix in the
US and increased demand in International. Infanrix/Pediarix decreased due to
competitive pressure in the US.
|
|
|
|
|
Specialty Medicines
|
Total
|
2,522
|
13%
|
17%
|
Excluding COVID
|
2,521
|
14%
|
19%
|
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.
In Q1 2024 HIV delivered double
digit growth, which was primarily driven by a 2 percentage point
increase in market share versus Q1 2023 as a result of strong
patient demand for Oral 2DR (Dovato, Juluca) and long-acting medicines
(Cabenuva,
Apretude), as well as
favourability in the quarter on pricing and tender
phasing.
Oral 2-drug regimens sales in the
quarter were £640 million, which now represents 40% of the total
HIV portfolio. Dovato continues to be the highest selling product in the HIV
portfolio with sales of £483 million in the quarter and growing 27%
versus Q1 2023.
|
|
|
|
Long-Acting Medicines
|
267
|
77%
|
83%
|
Long-Acting Medicine sales in the
quarter were £267 million, growing £116 million at AER; £125
million at CER versus Q1 2023 and now represent 17% of the total
HIV portfolio compared to 10% for Q1 2023. Cabenuva sales in Q1 2024 were £213
million and growing 73% driven by strong patient demand.
Apretude sales in Q1
2024 were £54 million, growing £30 million at AER; £32 million at
CER compared to Q1 2023.
|
|
|
|
Respiratory/Immunology and
Other
|
635
|
6%
|
11%
|
Sales primarily comprise
contributions from Nucala
in respiratory and Benlysta in immunology. In Q1 2024,
sales growth for Nucala
and Benlysta
increased, mainly driven by demand in European
and International markets. However, this performance was reduced by
the US, where the growth of the medicines remained broadly stable.
Volume demand growth was partly offset by the impact of channel
inventory reduction following a channel inventory build in Q4
2023.
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 Q1
2024, sales growth was driven by strong performances in Europe and
International regions, which reflected higher patient demand for
treatments addressing eosinophilic-led disease.
|
|
(1)
|
United States Census Bureau,
International Database, Year 2023.
|
|
|
|
|
|
Q1 2024
|
|
£m
|
AER
|
CER
|
Benlysta
|
260
|
3%
|
8%
|
Benlysta,
a monoclonal antibody treatment for Lupus, continues to grow
consistently, representing strong demand and volume growth in
European and International markets. Bio penetration rates have
increased in certain International markets, particularly in Japan
and China.
In Q1 2024, Oncology sales growth
increased driven by strong patient growth for Zejula, a PARP(1), Jemperli, a PD-1(2) blocking antibody, and
Ojjaara/Omjjara, a daily
JAK1/JAK2 and ACVR1(3) inhibitor. Jemperli, a medicine for front-line
treatment in combination with chemotherapy for patients with
dMMR/MSI-H primary advanced or recurrent endometrial cancer,
continued to grow strongly and delivered sales of £80 million in
the quarter. Ojjaara/Omjjara, a treatment for
myelofibrosis patients with anaemia, launched in the US in Q3 2023
and in the UK and Germany in Q1 2024, has seen strong uptake since
launch and delivered £52 million of sales in the
quarter.
Zejula delivered double-digit sales growth in the quarter, with
strong performances across all regions following increased patient
demand and higher volumes. In addition, new launches, particularly
in the International region, also contributed to the
performance.
|
|
|
|
General Medicines
|
2,564
|
(4%)
|
1%
|
Sales include contributions from
both the Respiratory and Other General Medicine portfolios. In Q1
2024, sales decreased 4% at AER but increased by 1% at CER. This
increase was driven primarily by strong demand across all regions
for Trelegy, a
chronic obstructive pulmonary disease (COPD) and asthma medicine.
The performance also included increased growth for
Anoro in Europe and
International, and a strong antibiotic performance in International
markets. However, this performance was primarily offset by a
decrease across the Established Respiratory and Other General
Medicine portfolios following the adverse impact of removing the
Average Manufacturer Price (AMP) cap on Medicaid drug prices in the
US. This removal particularly impacted the performance of
Advair,
Flovent, and
Lamictal in the quarter
due to significant pricing reductions, reduced commercial
contracting, and the decision to discontinue branded
Flovent. However, the
increased use of authorised generic versions of Advair and Flovent has partially offset the
impact of AMP cap removal while, significantly, continuing to
provide access to patients.
|
|
|
|
Respiratory
|
1,725
|
(2%)
|
2%
|
In Q1 2024, the increase in sales
growth reflected Trelegy's
strong performance in all regions and the
increased demand for Anoro, particularly in Europe and
International. However, as mentioned above, this was partially
offset by the decrease across the Established Respiratory portfolio
and the removal of the AMP cap.
Trelegy is the most prescribed single inhaler triple therapy (SITT)
treatment worldwide for COPD and asthma. In Q1 2024 sales growth
significantly increased across all regions, reflecting strong
patient demand, single-inhaled triple therapy class growth, and
increased market share.
|
|
|
|
Seretide/Advair
|
282
|
(17%)
|
(13%)
|
Seretide/Advair
is a combination treatment used to treat asthma
and COPD. In Q1 2024, the decrease in sales reflected continued
generic erosion from competitor products in Europe and
International and the removal of the AMP cap on Medicaid drug
prices in the US.
|
|
|
|
Other General Medicines
|
839
|
(7%)
|
(2%)
|
The performance in Q1 2024 was
adversely impacted by ongoing generic competition and the removal
of the AMP cap on Medicaid drug prices in the US, notably
impacting Lamictal's performance. This performance was partially offset by
increased antibiotic growth in International markets.
Footnotes:
(1)
|
PARP: a Poly ADP ribose
polymerase
|
(2)
|
PD-1: a programmed death receptor-1
blocking antibody
|
(3)
|
JAK1/JAK2 and ACVR1: once a-day,
oral JAK1/JAK2 and activin A receptor type 1 (ACVR1)
inhibitor
|
By Region
|
|
|
|
|
|
Q1 2024
|
|
£m
|
AER
|
CER
|
US
|
Total
|
3,589
|
10%
|
14%
|
|
Excluding COVID
|
3,589
|
10%
|
14%
|
Vaccine sales increased by
double-digits in Q1 2024, driven by continued strong consumer
uptake and Arexvy's leading market share. The decrease in Shingrix sales reflected the
comparison to Q1 2023, the prioritisation of other adult viral
respiratory season vaccines, and the increasing challenge of
activating harder to reach consumers. Favourable pricing and a
prior-period channel inventory reduction partly offset this
performance.
In Q1 2024, the sales of Specialty
Medicines increased, driven by strong HIV and Oncology
performances. However, despite increased patient demand, the
performances of Nucala and Benlysta remained broadly stable in the quarter, reflecting the impact
of channel inventory reductions.
General Medicine's growth in Q1
2024 was driven by increased demand for Trelegy and the growth of the SITT
market. However, this performance was offset by Established
Respiratory and Other General Medicines following the removal of
the AMP cap on Medicaid drug prices, which particularly
impacted Advair, Flovent,
and Lamictal.
|
|
|
|
|
Europe
|
Total
|
1,621
|
(5%)
|
(3%)
|
|
Excluding COVID
|
1,621
|
1%
|
3%
|
In Q1 2024, Vaccine sales growth
excluding COVID-19 solutions was broadly stable despite
Shingrix growth across
several markets following new national immunisation programmes.
Lower Bexsero tender deliveries partly offset this performance.
Specialty Medicines sales
increased by a double-digit percentage due to the performance in
HIV and Oncology. The performance of Benlysta in immunology and
Nucala in respiratory,
including the impact of new indication launches, also contributed
to the sales increase.
General Medicines sales were
broadly stable in the quarter, reflecting strong growth in
Trelegy and
Anoro, offset by a
decrease in Established Respiratory.
In Q1 2024, COVID-19 solutions
adversely impacted growth by six percentage points. Excluding this
impact, European sales increased by 3% at CER.
|
|
|
|
|
International
|
Total
|
2,153
|
9%
|
16%
|
|
Excluding COVID
|
2,152
|
11%
|
18%
|
In Q1 2024, sales excluding
COVID-19 solutions increased 11% at AER and 18% at CER, which
reflected year-on-year exchange movements in several International
markets compared to Q1 2023.
Vaccines' double-digit growth was
driven by the expansion of public funding for Shingrix in Australia and Japan,
together with earlier than anticipated supply to Zhifei, GSK's
co-promotion partner in China. Established vaccines also
contributed to growth due to increased demand and supply
phasing.
Specialty Medicine's double-digit
growth was driven by HIV, Nucala
in Respiratory, Benlysta in Immunology, and
Zejula in
Oncology.
General Medicines sales were
broadly stable, with Trelegy
and Antibiotics delivering growth offset by a
decrease in Other General Medicines and Established
Respiratory.
In Q1 2024, COVID-19 solutions
adversely impacted growth by two percentage points. Excluding this
impact, International sales grew 18% in Q1 2024.
|
|
|
|
|
|
|
Q1 2024
|
|
£m
|
|
% AER
|
|
% CER
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
(1,970)
|
|
1
|
|
2
|
Selling, general and
administration
|
(2,087)
|
|
(3)
|
|
-
|
Research and development
|
(1,434)
|
|
14
|
|
17
|
Royalty income
|
151
|
|
(16)
|
|
(16)
|
Other operating
income/(expense)
|
(533)
|
|
|
|
|
|
|
|
|
|
|
Operating profit
|
1,490
|
|
(28)
|
|
(18)
|
Net finance expense
|
(134)
|
|
(23)
|
|
(22)
|
Share of after tax profit/(loss) of
associates and joint ventures
|
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxation
|
(274)
|
|
|
|
|
Tax rate %
|
20.2%
|
|
|
|
|
|
|
|
|
|
|
Profit after taxation
|
1,081
|
|
(34)
|
|
(23)
|
Profit attributable to
non-controlling interests
|
35
|
|
|
|
|
Profit attributable to
shareholders
|
1,046
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share
|
25.7p
|
|
(30)
|
|
(19)
|
Financial Performance - Q1 2024
results unless otherwise stated, growth % and commentary at
CER.
|
|
Core results
Reconciliations between Total
results and Core results for Q1 2024 and Q1 2023, are set out on
pages 20 and 21.
|
|
|
|
|
|
|
|
Q1 2024
|
|
£m
|
|
% AER
|
|
% CER
|
Turnover
|
7,363
|
|
6
|
|
10
|
Cost of sales
|
(1,733)
|
|
(1)
|
|
-
|
Selling, general and
administration
|
(1,979)
|
|
(4)
|
|
(2)
|
Research and development
|
(1,359)
|
|
11
|
|
14
|
Royalty income
|
151
|
|
(16)
|
|
(16)
|
|
|
|
|
|
|
Core operating profit
|
2,443
|
|
17
|
|
27
|
|
|
|
|
|
|
Core profit before
taxation
|
2,310
|
|
20
|
|
32
|
Taxation
|
(404)
|
|
33
|
|
46
|
Core profit after
taxation
|
1,906
|
|
18
|
|
29
|
Core profit attributable to
non-controlling interests
|
154
|
|
|
|
|
Core profit attributable to
shareholders
|
1,752
|
|
|
|
|
|
1,906
|
|
18
|
|
29
|
Earnings per share
|
43.1p
|
|
16
|
|
28
|
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Cost of sales
|
Total
|
1,970
|
1%
|
2%
|
% of sales
|
26.8%
|
(1.2%)
|
(2.1%)
|
Core
|
1,733
|
(1%)
|
-
|
% of sales
|
23.5%
|
(1.7%)
|
(2.5%)
|
Total and Core cost of sales as a
percentage of sales decreased in Q1 2024 primarily driven by mix
benefits from the growth in higher margin Arexvy, Shingrix and Specialty products as
well as regional margin mix from higher US sales.
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Selling, general &
administration
|
Total
|
2,087
|
(3%)
|
-
|
% of sales
|
28.3%
|
(2.5%)
|
(3.0%)
|
Core
|
1,979
|
(4%)
|
(2%)
|
% of sales
|
26.9%
|
(2.8%)
|
(3.3%)
|
Disciplined SG&A investment to
support global market expansion and disease awareness for
Arexvy and
Shingrix was more than
offset by a 6 percentage point favourable impact of the reversal of
the legal provision taken in Q1 2023 for the Zejula royalty dispute, following a
successful appeal. Total SG&A also included an increase in
significant legal costs reflecting increased legal fees (see
details on page 22).
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Research &
development
|
Total
|
1,434
|
14%
|
17%
|
% of sales
|
19.5%
|
1.3%
|
1.0%
|
Core
|
1,359
|
11%
|
14%
|
% of sales
|
18.5%
|
0.9%
|
0.6%
|
In Q1 2024, R&D expense
increased due to continued investment across disease areas,
including bepirovirsen (chronic hepatitis B) and the advancement of
clinical trial programmes associated with the pneumococcal Multi
Antigen Presenting System (MAPS) and mRNA in Infectious
Diseases.
In HIV, early-stage research
expenses increased following investment in next-generation
long-acting treatment and preventative medicines. In Respiratory
and Oncology, investment increased to support lifecycle innovation
and late-stage clinical development programmes for depemokimab
(asthma and eosinophilic inflammation), camlipixant (refractory
chronic cough), and Jemperli
(endometrial cancer). Lower R&D expenses
predominately related to Arexvy
in Infectious Disease and Zejula and Ojjaara in Oncology partly offset
this.
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Royalty income
|
Total
|
151
|
(16%)
|
(16%)
|
|
Core
|
151
|
(16%)
|
(16%)
|
The decrease in Total and Core
royalty income in Q1 2024 is primarily related to the cessation of
the majority of Gardasil royalties at the end of 2023, with Q1 2024
Gardasil royalties of £22 million (Q1 2023: £71 million). This was
partly offset by increases in Kesimpta and Biktarvy
royalties.
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Other operating
income/(expense)
|
Total
|
(533)
|
>(100%)
|
>(100%)
|
In Q1 2024 other operating expense
reflected a charge of £685 million (Q1 2023: £271 million credit)
arising from the remeasurement of contingent consideration
liabilities primarily reflecting improved longer term HIV prospects
and foreign currency movements and the liabilities for the Pfizer,
Inc. (Pfizer) put option. This was partly offset by a fair value
gain of £57 million (Q1 2023: £65 million loss) on the retained
stake in Haleon plc (Haleon) and other net income of £95 million
(Q1 2023: £91 million).
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Operating profit
|
Total
|
1,490
|
(28%)
|
(18%)
|
|
% of sales
|
20.2%
|
(9.7%)
|
(7.8%)
|
|
Core
|
2,443
|
17%
|
27%
|
|
% of sales
|
33.2%
|
3.1%
|
4.6%
|
Total operating profit margin was
lower in Q1 2024 primarily due to unfavourable movements in
contingent consideration liabilities reflecting improved longer
term HIV prospects and foreign currency movement, partly offset by
a fair value gain on the retained stake in Haleon (Q1 2023 fair
value loss).
Core operating profit in the
quarter benefitted from strong sales, favourable product mix and
the reversal of the legal provision taken in Q1 2023 for the
Zejula royalty dispute,
following a successful appeal. This was partly offset by increased
investment in R&D and growth assets, and lower royalty income.
The adverse impact of lower sales of COVID-19 solutions was eight
percentage points of Core operating profit growth, with minimal
impact on Core operating profit margin.
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Net finance costs
|
Total
|
134
|
(23%)
|
(22%)
|
|
Core
|
132
|
(22%)
|
(22%)
|
The decrease in net finance costs
in Q1 2024 was mainly driven by the net cost of certain bond
buybacks completed in Q1 2023 and higher interest income on
cash.
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Taxation
|
Total
|
274
|
(1%)
|
13%
|
|
Tax rate %
|
20.2%
|
|
|
|
Core
|
404
|
33%
|
46%
|
|
Tax rate %
|
17.5%
|
|
|
The effective tax rate on Core
profits is broadly in line with expectations for the year and
includes the impact of the OECD's BEPS Pillar Two model
framework which came into effect from 1 January 2024. 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.
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m
|
AER
|
CER
|
Non-controlling
interests ("NCIs")
|
Total
|
35
|
(75%)
|
(66%)
|
Core
|
154
|
27%
|
38%
|
The decrease in Total profit
allocated to NCIs in the quarter was primarily driven by lower ViiV
Healthcare profits (including the remeasurement loss on the
contingent consideration liability) with an allocation of £28
million (Q1 2023: £140 million), partly offset by higher net
profits in some of the Group's other entities.
The increase in Core profit from
operations allocated to NCIs in Q1 2024 primarily reflected higher
profit allocations from ViiV Healthcare of £147 million (Q1 2023:
£120 million), as well as higher net profits in some of the Group's
other entities with NCIs.
|
|
|
|
|
|
|
Q1 2024
|
|
|
£p
|
AER
|
CER
|
Earnings per share
|
Total
|
25.7p
|
(30%)
|
(19%)
|
Core
|
43.1p
|
16%
|
28%
|
The increase in the Core EPS in
the quarter reflected the growth in Core operating profit as well
as lower finance costs, partly offset by higher non-controlling
interests and a higher effective taxation rate. Lower sales of
COVID-19 solutions reduced Core EPS by nine percentage
points.
The decrease in the Q1 2024 Total
EPS primarily reflected higher charges related to the remeasurement
of contingent consideration liabilities reflecting improved longer
term HIV prospects and foreign currency movement partly offset by a
fair value gain on the retained stake in Haleon (compared to a fair
value loss in Q1 2023) and a favourable benefit from lower
non-controlling interests.
Currency impact on
results
The results for Q1 2024 are based
on average exchange rates, principally £1/$1.27, £1/€1.16 and
£1/Yen 187. The period-end exchange rates were £1/$1.26, £1/€1.17
and £1/Yen 191. Comparative exchange rates are given on page
34.
|
|
|
|
|
|
|
Q1 2024
|
|
|
£m/£p
|
AER
|
CER
|
Turnover
|
|
7,363
|
6%
|
10%
|
Earnings per share
|
Total
|
25.7p
|
(30%)
|
(19%)
|
Core
|
43.1p
|
16%
|
28%
|
In Q1 2024, the adverse currency
impact primarily reflected the strengthening of Sterling against
the US Dollar, Euro and Yen, as well as the weakening of emerging
market currencies against Sterling. Exchange gains or losses on the
settlement of intercompany transactions had an adverse two
percentage point impact on Core EPS.
|
|
|
|
Cash flow
|
|
Q1 2024
£m
|
|
Q1 2023
£m
|
|
|
|
|
Cash generated from operations
(£m)
|
1,126
|
|
287
|
|
|
|
|
Net cash generated from operating
activities (£m)
|
|
|
|
|
|
|
|
Free cash inflow/(outflow)*
(£m)
|
289
|
|
(689)
|
Free cash flow growth (%)
|
>100%
|
|
>(100)%
|
Free cash flow conversion*
(%)
|
28%
|
|
3%
|
Total net debt** (£m)
|
14,961
|
|
17,950
|
|
Free cash flow and free cash
flow conversion are defined on page 47. Free cash flow is analysed
on page 37.
|
|
Net debt is analysed on page
37.
|
Q1 2024
Cash generated from operations for
the quarter was £1,126 million (Q1 2023: £287 million). The
increase primarily reflected higher operating profit and higher
receivables' collections, driven by the timing of sales and
collections particularly for Arexvy, partly offset by timing of
returns and rebates.
Total contingent consideration
cash payments in the quarter were £309 million (Q1 2023:
£291 million), including cash payments made to Shionogi &
Co. Ltd (Shionogi) of £300 million (Q1 2023:
£287 million). £306 million (Q1 2023: £290 million) of
these were recognised in cash flows from operating
activities.
Free cash inflow was £289 million
for the quarter (Q1 2023: £689 million outflow). In addition
to the increase in cash generated from operations the increase in
free cash flow in the quarter was primarily driven by lower tax
payments, lower net interest paid and lower dividends paid to
non-controlling interests. This was partly offset by increased
capital expenditure.
Total Net debt
At 31 March 2024, net debt was
£14,961 million, compared with £15,040 million at 31 December 2023,
comprising gross debt of £17,772 million and cash and liquid
investments of £2,811 million. See net debt information on page
36.
Net debt decreased by £79 million
primarily due to £289 million free cash inflow and £1,055 million
proceeds from the disposal of investments, including the partial
sale of the retained stake in Haleon. This was partly offset by the
net acquisition cost of Aiolos Bio, Inc. (Aiolos) for £719 million
and dividends paid to shareholders of £568 million.
At 31 March 2024, GSK had
short-term borrowings (including overdrafts and lease liabilities)
repayable within 12 months of £2,616 million with loans of £1,431
million repayable in the subsequent year.
|
|
Contents
|
Page
|
Q1 2024 pipeline
highlights
|
14
|
ESG
|
16
|
Total and Core results
|
18
|
Income statement
|
23
|
Statement of comprehensive
income
|
24
|
Balance sheet
|
25
|
Statement of changes in
equity
|
26
|
Cash flow statement - three months
ended 31 March 2024
|
27
|
Sales tables - three months ended
31 March 2024
|
28
|
Segment information
|
31
|
Legal matters
|
32
|
Returns to shareholders
|
33
|
Additional information
|
34
|
Net debt information
|
36
|
Related party
transactions
|
37
|
R&D commentary
|
38
|
Reporting definitions
|
47
|
Guidance, assumptions and
cautionary statements
|
49
|
Independent Auditor's review report
to GSK plc
|
50
|
|
GSK plc (LSE/NYSE:GSK) is a global
biopharma company with a purpose to unite science, technology, and
talent to get ahead of disease together. Find out more at
www.gsk.com.
|
|
|
|
|
GSK enquiries:
|
|
|
|
Media
|
Tim Foley
|
+44 (0) 20 8047 5502
|
(London)
|
|
Kathleen Quinn
|
+1 202 603 5003
|
(Washington)
|
|
|
|
|
Investor Relations
|
Nick Stone
|
+44 (0) 7717 618834
|
(London)
|
|
James Dodwell
|
+44 (0) 7881 269066
|
(London)
|
|
Mick Readey
|
+44 (0) 7990 339653
|
(London)
|
|
Joshua Williams
|
+44 (0) 7385 415719
|
(London)
|
|
Jeff McLaughlin
|
+1 215 589 3774
|
(Philadelphia)
|
|
|
|
|
Registered in England &
Wales:
No. 3888792
|
|
Registered
Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
|
|
Q1 2024 pipeline highlights (since
31 January 2024)
|
|
|
|
|
|
Medicine/vaccine
|
Trial (indication,
presentation)
|
Event
|
Regulatory submissions or
acceptances
|
Arexvy
|
RSV, adults aged 50-59
years
|
Regulatory acceptance
(US)
|
MenABCWY (gen 1) vaccine
candidate
|
Meningococcal ABCWY
|
Regulatory acceptance
(US)
|
Shingrix
|
Shingles, adults aged 18+
years
|
Regulatory acceptance
(CN)
|
Jemperli
|
RUBY part 1 (OS overall population,
1L endometrial cancer)
|
Regulatory acceptance
(US)
|
Phase III data readouts or other
significant events
|
gepotidacin
|
EAGLE-1 (urogenital
gonorrhoea)
|
Positive phase III data
readout
|
Blenrep
|
DREAMM-8 (2L + multiple
myeloma)
|
Positive phase III data
readout
|
cabotegravir
|
LATITUDE (HIV long-acting
injectable)
|
Positive phase III data
readout
|
Jemperli
|
RUBY Part 1 (OS) and Part 2 (PFS)
(1L endometrial cancer)
|
Additional positive phase III data
readout
|
|
|
|
|
Timing
|
Medicine/vaccine
|
Trial (indication,
presentation)
|
Event
|
H1 2024
|
Arexvy
|
RSV, older adults aged 50-59
years
|
Regulatory decision (US)
|
momelotinib
|
MOMENTUM (myelofibrosis with
anaemia)
|
Regulatory decision (JP)
|
depemokimab
|
SWIFT-1/2 (severe asthma)
|
Phase III data readout
|
H2 2024
|
Arexvy
|
RSV, older adults aged 50-59
years
|
Regulatory decision (EU,
JP)
|
gepotidacin
|
EAGLE-2/3 (uncomplicated urinary
tract infection)
|
Regulatory submission
(US)
|
MenABCWY (gen 1)
vaccine candidate
|
Meningococcal ABCWY
|
Regulatory submission
(EU)
|
depemokimab
|
ANCHOR-1/2 (chronic rhinosinusitis
with nasal polyps)
|
Phase III data readout
|
depemokimab
|
ANCHOR-1/2 (chronic rhinosinusitis
with nasal polyps)
|
Regulatory submission
(US)
|
depemokimab
|
SWIFT-1/2 (severe asthma)
|
Regulatory submission
(US)
|
Nucala
|
Chronic rhinosinusitis with nasal
polyps
|
Regulatory decision (JP)
|
Nucala
|
MATINEE (chronic obstructive
pulmonary disease)
|
Phase III data readout
|
Nucala
|
MATINEE (chronic obstructive
pulmonary disease)
|
Regulatory submission
(US)
|
Blenrep
|
DREAM-7/8 (2L + multiple
myeloma)
|
Regulatory submission
(US, EU, JP)
|
Blenrep
|
DREAMM-7 (2L + multiple
myeloma)
|
Regulatory submission
(CN)
|
Jemperli
|
RUBY part 1 (OS overall population,
1L endometrial cancer)
|
Regulatory decision (US)
|
Jemperli
|
RUBY part 1 (OS overall population,
1L endometrial cancer)
|
Regulatory submission
(EU)
|
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
|
2025
|
gepotidacin
|
EAGLE-2/3 (uncomplicated urinary
tract infection)
|
Regulatory decision (US)
|
gepotidacin
|
EAGLE-1 (urogenital
gonorrhoea)
|
Regulatory submission
(US)
|
gepotidacin
|
EAGLE-1 (urogenital
gonorrhoea)
|
Regulatory decision (US)
|
geopotidacin
|
EAGLE-J (uncomplicated urinary tract
infection)
|
Regulatory submission
(JP)
|
MenABCWY (gen 1) vaccine
candidate
|
Meningococcal ABCWY
|
Regulatory decision (US)
|
Shingrix
|
Shingles, adults aged 18+
years
|
Regulatory decision (CN)
|
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,
JP)
|
depemokimab
|
SWIFT-1/2 (severe asthma)
|
Regulatory submission
(EU, CN, JP)
|
depemokimab
|
ANCHOR-1/2 (chronic rhinosinusitis
with nasal polyps)
|
Regulatory decision (US,
JP)
|
depemokimab
|
ANCHOR-1/2 (chronic rhinosinusitis
with nasal polyps)
|
Regulatory submission
(EU, CN, JP)
|
depemokimab
|
OCEAN (eosinophilic granulomatosis
with polyangiitis)
|
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)
|
Blenrep
|
DREAMM-7/8 (2L+ multiple
myeloma)
|
Regulatory decision
(US, EU, JP)
|
Blenrep
|
DREAMM-8 (2L+ multiple
myeloma)
|
Regulatory submission
(CN)
|
cobolimab
|
COSTAR (non-small cell lung
cancer)
|
Phase III data readout
|
cobolimab
|
COSTAR, (2L non-small cell lung
cancer)
|
Regulatory submission
(US, EU)
|
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, JP)
|
linerixibat
|
GLISTEN (cholestatic pruritus in
primary biliary cholangitis)
|
Regulatory decision (US)
|
Refer to pages 38 to 46 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 Q4 2023
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 Q4 2023:
|
|
•
|
GSK announced a cap of $35 per
month on eligible U.S. patient out-of-pocket costs for its entire
portfolio of asthma and COPD inhalers. This announcement builds on
GSK's decades-long commitment to making products accessible to
those who need them. More information can be found
here. (2)
|
•
|
GSK announced additional funding
and new data and resources under the COiMMUNITY Initiative to help
achieve higher adult vaccination rates and health equity in the US
and address ongoing barriers to adult immunisation. In 2024, GSK is
giving up to $2 million in COiMMUNITY Initiative grants. More
information can be found
here. (3)
|
•
|
Performance metrics related to
access are updated annually with related details in GSK's ESG
Performance Report 2023 on page 10.
|
Global health and health
security
Commitment: develop novel products
and technologies to treat and prevent priority diseases, including
pandemic threats.
Progress since Q4 2023:
|
|
•
|
GSK announced positive headline
results from EAGLE-1 phase III trial for gepotidacin in
uncomplicated urogenital gonorrhoea. Neisseria gonorrhoeae, the
bacteria causing gonorrhoea, is recognised by the World Health
Organisation as a priority pathogen, for which resistance to
existing treatments is rising. More information can be found
here. (4)
|
•
|
In March, the GSK-developed
tuberculosis (TB) vaccine candidate M72/AS01E entered phase III
trials, sponsored by Wellcome and the Bill & Melinda Gates
Medical Research Institute. This is the first potential new TB
vaccine which meets the WHO target product profile in over 100
years. More information on GSK's TB and Global health efforts can
be found
here. (5)
|
•
|
Performance metrics related to
global health and health security are updated annually with related
details in GSK's ESG Performance Report 2023 on page 15.
|
Environment
Commitment: committed to a net
zero, nature-positive, healthier planet with ambitious goals set
for 2030 and 2045.
Progress since Q4 2023:
|
|
•
|
In February, the global
environmental non-profit CDP published its annual scoring of
corporate environmental performance. CDP sets high and constantly
evolving standards for environmental leadership to support
companies to improve their level of ambition and action on climate
and nature. This year's results, which are based on 2022
performance, reflect a year-over-year improvement for GSK for Water
Security score (A- from B) and a continued high A- score for
Climate Change. GSK also scored well in two Forest commodities
receiving a B for paper and B for palm oil.
|
•
|
In February, GSK announced a
virtual power purchase agreement to source renewable electricity
through two new solar projects in Spain to facilitate 50% of its
European sites' electricity demand for 12 years, from
mid-2026.
|
•
|
Whilst GSK is focused on emissions
reductions to meet its carbon targets, at the same time, it is
investing in high quality nature protection and restoration
projects that support GSK's net-zero and nature positive goals, and
deliver co-benefits to human health. In March, GSK disclosed it has
invested in Climate Asset Management's Nature Based Carbon Fund,
which aims to invest in nature projects in developing economies, to
provide long-lasting, verified, positive impact at scale for the
climate, biodiversity and local communities. This is a long-term
investment over the next 15 years, which aims to secure
approximately a quarter of credits needed in 2030, to meet GSK's
commitment to invest in nature-based solutions for 20% of its 2020
footprint.
|
•
|
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.
Progress since Q4 2023:
|
|
•
|
Performance metrics related to
diversity, equity and inclusion are updated annually with related
details in GSK's ESG Performance Report 2023 on page 26.
|
Ethical standards
Commitment: promote ethical
behaviour across GSK's business by supporting its employees to do
the right thing and working with suppliers that share GSK's
standards and operate responsibly.
|
|
•
|
Performance metrics related to
ethical standards are updated annually with related details in
GSK's ESG Performance Report 2023 on page 30.
|
Product governance
Commitment: maintain robust
quality and safety processes and responsibly use data and new
technologies.
|
|
•
|
Performance metrics related to
product governance are updated annually with related details in
GSK's ESG Performance Report 2023 on page 35.
|
ESG rating performance
Detailed below is how GSK performs
in key ESG ratings.
|
|
|
|
|
|
|
|
S&P Global's Corporate
Sustainability Assessment
|
84
|
86
|
1st in the pharmaceutical industry
group; Assessment conducted annually, current score updated Nov
2023
|
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 Feb 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
|
16.7
|
18.6
|
1st percentile in pharma
subindustry group; Lower score represents lower risk. Current
ranking updated Sept 2023
|
MSCI
|
AA
|
AA
|
Last rating action date: Sept
2023
|
Moody's ESG solutions
|
62
|
61
|
Current score updated Aug
2023
|
ISS Corporate Rating
|
B+
|
B+
|
Current score updated June
2023
|
FTSE4Good
|
Member
|
Member
|
Member since 2004, latest review in
June 2023
|
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 has made one update to its
reporting framework in Q1 2024 which is to change the description
of Adjusted results to Core results to align with European peers in
the pharmaceutical industry but with no change to the basis or
figures. There is no change to Total Results or the definition of
Adjusting items.
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 47.
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
|
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 21.
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 three months ended 31 March 2024
were £300 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 Q1 2024 and Q1 2023 are set out
below.
Three months ended 31 March
2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
results
£m
|
|
Intangible
amort-
isation
£m
|
|
Intangible
impair-
ment
£m
|
|
Major
restruct-
uring
£m
|
|
Trans-
action-
related
£m
|
|
Divest-
ments,
significant
legal and
other
items
£m
|
|
Core
results
£m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Turnover
|
7,363
|
|
|
|
|
|
|
|
|
|
|
|
7,363
|
Cost of sales
|
(1,970)
|
|
182
|
|
|
|
33
|
|
19
|
|
3
|
|
(1,733)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
5,393
|
|
182
|
|
|
|
33
|
|
19
|
|
3
|
|
5,630
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administration
|
(2,087)
|
|
|
|
|
|
17
|
|
|
|
91
|
|
(1,979)
|
Research and development
|
(1,434)
|
|
14
|
|
54
|
|
7
|
|
|
|
|
|
(1,359)
|
Royalty income
|
151
|
|
|
|
|
|
|
|
|
|
|
|
151
|
Other operating
income/(expense)
|
(533)
|
|
|
|
|
|
|
|
685
|
|
(152)
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating profit
|
1,490
|
|
196
|
|
54
|
|
57
|
|
704
|
|
(58)
|
|
2,443
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net finance cost
|
(134)
|
|
|
|
|
|
|
|
|
|
2
|
|
(132)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share of after tax profit/(loss) of
associates
and joint ventures
|
(1)
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit before taxation
|
1,355
|
|
196
|
|
54
|
|
57
|
|
704
|
|
(56)
|
|
2,310
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxation
|
(274)
|
|
(41)
|
|
(14)
|
|
(13)
|
|
(76)
|
|
14
|
|
(404)
|
Tax rate %
|
20.2%
|
|
|
|
|
|
|
|
|
|
|
|
17.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit after taxation
|
1,081
|
|
155
|
|
40
|
|
44
|
|
628
|
|
(42)
|
|
1,906
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit attributable to
non-controlling
interests
|
35
|
|
|
|
|
|
|
|
119
|
|
|
|
154
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit attributable to
shareholders
|
1,046
|
|
155
|
|
40
|
|
44
|
|
509
|
|
(42)
|
|
1,752
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,081
|
|
155
|
|
40
|
|
44
|
|
628
|
|
(42)
|
|
1,906
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share
|
25.7p
|
|
3.8p
|
|
1.0p
|
|
1.1p
|
|
12.5p
|
|
(1.0p)
|
|
43.1p
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
(millions)
|
4,069
|
|
|
|
|
|
|
|
|
|
|
|
4,069
|
Three months ended 31 March
2023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
results
£m
|
|
Intangible
amort-
isation
£m
|
|
Intangible
impair-
ment
£m
|
|
Major
restruct-
uring
£m
|
|
Trans-
action-
related
£m
|
|
Divest-
ments,
significant
legal and
other
items
£m
|
|
Core
results
£m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Turnover
|
6,951
|
|
|
|
|
|
|
|
|
|
|
|
6,951
|
Cost of sales
|
(1,943)
|
|
151
|
|
|
|
35
|
|
|
|
5
|
|
(1,752)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
5,008
|
|
151
|
|
|
|
35
|
|
|
|
5
|
|
5,199
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administration
|
(2,143)
|
|
|
|
|
|
69
|
|
|
|
9
|
|
(2,065)
|
Research and development
|
(1,260)
|
|
18
|
|
16
|
|
4
|
|
|
|
|
|
(1,222)
|
Royalty income
|
180
|
|
|
|
|
|
|
|
|
|
|
|
180
|
Other operating
income/(expense)
|
297
|
|
|
|
|
|
|
|
(271)
|
|
(26)
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating profit
|
2,082
|
|
169
|
|
16
|
|
108
|
|
(271)
|
|
(12)
|
|
2,092
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net finance cost
|
(174)
|
|
|
|
|
|
|
|
|
|
4
|
|
(170)
|
Share of after tax profit/(loss) of
associates
and joint ventures
|
(2)
|
|
|
|
|
|
|
|
|
|
|
|
(2)
|
Profit/(loss) on disposal of
interest in
associates
|
1
|
|
|
|
|
|
|
|
|
|
(1)
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxation
|
(276)
|
|
(36)
|
|
(4)
|
|
(22)
|
|
15
|
|
20
|
|
(303)
|
Tax rate %
|
14.5%
|
|
|
|
|
|
|
|
|
|
|
|
15.8%
|
Profit after taxation
|
1,631
|
|
133
|
|
12
|
|
86
|
|
(256)
|
|
11
|
|
1,617
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit attributable to
non-controlling
interests
|
141
|
|
|
|
|
|
|
|
(20)
|
|
|
|
121
|
Profit attributable to
shareholders
|
1,490
|
|
133
|
|
12
|
|
86
|
|
(236)
|
|
11
|
|
1,496
|
|
1,631
|
|
133
|
|
12
|
|
86
|
|
(256)
|
|
11
|
|
1,617
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share
|
36.8p
|
|
3.3p
|
|
0.3p
|
|
2.1p
|
|
(5.8p)
|
|
0.3p
|
|
37.0p
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
(millions)
|
4,044
|
|
|
|
|
|
|
|
|
|
|
|
4,044
|
Major restructuring and
integration
Total Major restructuring charges
incurred in Q1 2024 were £57 million (Q1 2023: £108 million),
analysed as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 2024
|
|
Q1 2023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
£m
|
|
Non-
cash
£m
|
|
Total
£m
|
|
Cash
£m
|
|
Non-
cash
£m
|
|
Total
£m
|
|
|
|
|
|
|
|
|
|
|
|
|
Separation Preparation
restructuring
programme
|
28
|
|
8
|
|
36
|
|
37
|
|
47
|
|
84
|
Significant acquisitions
|
19
|
|
-
|
|
19
|
|
21
|
|
1
|
|
22
|
Legacy programmes
|
2
|
|
-
|
|
2
|
|
-
|
|
2
|
|
2
|
|
49
|
|
8
|
|
57
|
|
58
|
|
50
|
|
108
|
The Separation Preparation
programme incurred cash charges of £28 million primarily from
restructuring in Global Supply Chain as well as some commercial and
administrative functions. The non-cash charges of £8 million
primarily reflected the write down of assets in manufacturing
locations.
Costs of significant acquisitions
relate to integration costs of Sierra Oncology Inc. (Sierra) and
Affinivax Inc. (Affinivax) which were acquired in Q3 2022, BELLUS
Health Inc. (Bellus) acquired in Q2 2023 and Aiolos acquired in Q1
2024.
Transaction-related
adjustments
Transaction-related adjustments
resulted in a net charge of £704 million (Q1 2023: £271 million
credit), the majority of which related to charges/credits for the
remeasurement of contingent consideration liabilities, the
liabilities for the Pfizer put option, and Pfizer and Shionogi
preferential dividends in ViiV Healthcare.
|
|
|
|
Charge/(credit)
|
Q1 2024
£m
|
|
Q1 2023
£m
|
Contingent consideration on former
Shionogi-ViiV Healthcare joint Venture
(including Shionogi
preferential dividends)
|
586
|
|
(64)
|
ViiV Healthcare put options and
Pfizer preferential dividends
|
66
|
|
(105)
|
Contingent consideration on former
Novartis Vaccines business
|
28
|
|
(69)
|
Contingent consideration on
acquisition of Affinivax
|
5
|
|
(33)
|
Other adjustments
|
19
|
|
-
|
|
|
|
|
Total transaction-related
charges
|
704
|
|
(271)
|
The £586 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 £479 million
from updated sales forecasts and exchange rates, and the unwind of
the discount for £107 million. The £66 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 £28 million charge relating to
the contingent consideration on the former Novartis Vaccines
business primarily relates to changes to future sales
forecasts.
The £5 million charge relating to
the contingent consideration on the acquisition of Affinivax
primarily relates to the unwind of the discount.
Divestments, significant legal
charges, and other items
Divestments, significant legal
charges, and other items primarily included fair value gains on
investments, including a £57 million fair value gain on the
investment in Haleon and other net income of £95 million. Legal
charges provide for all significant legal matters and are not
broken out separately by litigation or investigation. Significant
legal charges in the quarter primarily reflected prospective legal
costs for the defence of the litigation relating to
Zantac.
|
Financial information
|
Income statements
|
|
|
|
|
|
Q1 2024
£m
|
|
Q1 2023
£m
|
|
|
|
|
TURNOVER
|
7,363
|
|
6,951
|
|
|
|
|
Cost of sales
|
(1,970)
|
|
(1,943)
|
Gross profit
|
5,393
|
|
5,008
|
|
|
|
|
Selling, general and
administration
|
(2,087)
|
|
(2,143)
|
Research and development
|
(1,434)
|
|
(1,260)
|
Royalty income
|
151
|
|
180
|
Other operating
income/(expense)
|
(533)
|
|
297
|
|
|
|
|
OPERATING PROFIT
|
1,490
|
|
2,082
|
|
|
|
|
Finance income
|
32
|
|
29
|
Finance expense
|
(166)
|
|
(203)
|
Share of after tax profit/(loss) of
associates and joint ventures
|
(1)
|
|
(2)
|
Profit/(loss) on disposal of
interests in associates and joint ventures
|
-
|
|
1
|
|
|
|
|
PROFIT BEFORE TAXATION
|
1,355
|
|
1,907
|
|
|
|
|
Taxation
|
(274)
|
|
(276)
|
Tax rate %
|
20.2%
|
|
14.5%
|
|
|
|
|
PROFIT AFTER TAXATION
|
1,081
|
|
1,631
|
|
|
|
|
Profit attributable to
non-controlling interests
|
35
|
|
141
|
Profit attributable to
shareholders
|
1,046
|
|
1,490
|
|
1,081
|
|
1,631
|
|
|
|
|
EARNINGS PER SHARE
|
25.7p
|
|
36.8p
|
|
|
|
|
Diluted earnings per
share
|
25.4p
|
|
36.5p
|
|
|
|
|
|
Statement of comprehensive
income
|
|
|
|
|
|
Q1 2024
£m
|
|
Q1 2023
£m
|
|
|
|
|
Total profit for the
period
|
1,081
|
|
1,631
|
|
|
|
|
Items that may be reclassified
subsequently to income statement:
|
|
|
|
Exchange movements on overseas net
assets and net investment hedges
|
(190)
|
|
87
|
Reclassification of exchange
movements on liquidation or disposal of
overseas subsidiaries and
associates
|
-
|
|
(3)
|
Reclassification of cash flow hedges
to income statement
|
2
|
|
1
|
|
|
|
|
|
(188)
|
|
85
|
|
|
|
|
Items that will not be reclassified
to income statement:
|
|
|
|
Exchange movements on overseas net
assets of non-controlling interests
|
3
|
|
(14)
|
Fair value movements on equity
investments
|
78
|
|
(168)
|
Tax on fair value movements on
equity investments
|
(15)
|
|
22
|
Fair value movements on cash flow
hedges
|
1
|
|
-
|
Remeasurement gains/(losses) on
defined benefit plans
|
46
|
|
350
|
Tax on remeasurement losses/(gains)
on defined benefit plans
|
(10)
|
|
(87)
|
|
|
|
|
|
103
|
|
103
|
|
|
|
|
Other comprehensive income/(expense)
for the period
|
(85)
|
|
188
|
|
|
|
|
Total comprehensive income for the
period
|
996
|
|
1,819
|
|
|
|
|
|
|
|
|
Total comprehensive income for the
period attributable to:
|
|
|
|
Shareholders
|
958
|
|
1,692
|
Non-controlling interests
|
38
|
|
127
|
|
|
|
|
|
996
|
|
1,819
|
|
|
|
|
|
31 March 2024
£m
|
|
31 December 2023
£m
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments in associates and joint
ventures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-current assets
|
41,306
|
|
40,361
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade and other
receivables
|
|
|
|
Derivative financial
instruments
|
|
|
|
Current equity
investments
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
17,205
|
|
18,644
|
|
|
|
|
TOTAL ASSETS
|
58,511
|
|
59,005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration
liabilities
|
|
|
|
|
|
|
|
Derivative financial
instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
(19,846)
|
|
(21,068)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pensions and other post-employment
benefits
|
|
|
|
|
|
|
|
Contingent consideration
liabilities
|
|
|
|
Other non-current
liabilities
|
|
|
|
|
|
|
|
Total non-current
liabilities
|
(25,436)
|
|
(25,142)
|
|
|
|
|
TOTAL LIABILITIES
|
(45,282)
|
|
(46,210)
|
|
|
|
|
NET ASSETS
|
13,229
|
|
12,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-controlling interests
|
|
|
|
|
|
|
|
TOTAL EQUITY
|
13,229
|
|
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
|
|
|
|
|
1,046
|
|
|
|
1,046
|
|
35
|
|
1,081
|
Other
comprehensive
income/(expense) for
the period
|
|
|
|
|
(151)
|
|
63
|
|
(88)
|
|
3
|
|
(85)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
income/(expense)
for the period
|
|
|
|
|
895
|
|
63
|
|
958
|
|
38
|
|
996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributions to non-controlling
interests
|
|
|
|
|
|
|
|
|
|
|
(97)
|
|
(97)
|
Dividends to
shareholders
|
|
|
|
|
(568)
|
|
|
|
(568)
|
|
|
|
(568)
|
Realised after tax losses on
disposal
or liquidation of equity
investments
|
|
|
|
|
(47)
|
|
47
|
|
|
|
|
|
-
|
Share of associates and joint
ventures
realised profit/(loss) on
disposal of
equity
investments
|
|
|
|
|
15
|
|
(15)
|
|
|
|
|
|
-
|
Shares issued
|
|
|
18
|
|
|
|
|
|
18
|
|
|
|
18
|
Write-down on shares held by ESOP
Trusts
|
|
|
|
|
(141)
|
|
141
|
|
|
|
|
|
-
|
Shares acquired by ESOP
Trusts
|
|
|
2
|
|
457
|
|
(459)
|
|
|
|
|
|
-
|
Share-based incentive
plans
|
|
|
|
|
85
|
|
|
|
85
|
|
|
|
85
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 March 2024
|
1,348
|
|
3,471
|
|
7,935
|
|
1,086
|
|
13,840
|
|
(611)
|
|
13,229
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
1,490
|
|
-
|
|
1,490
|
|
141
|
|
1,631
|
Other
comprehensive
income/(expense) for
the period
|
|
|
|
|
336
|
|
(134)
|
|
202
|
|
(14)
|
|
188
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
income/(expense)
for the period
|
|
|
|
|
1,826
|
|
(134)
|
|
1,692
|
|
127
|
|
1,819
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributions to non-controlling
interests
|
|
|
|
|
|
|
|
|
|
|
(140)
|
|
(140)
|
Contributions from
non-controlling
interests
|
|
|
|
|
|
|
|
|
|
|
7
|
|
7
|
Dividends to
shareholders
|
|
|
|
|
(555)
|
|
|
|
(555)
|
|
|
|
(555)
|
Realised after tax losses on
disposal or
liquidation of equity
investments
|
|
|
|
|
(13)
|
|
13
|
|
|
|
|
|
-
|
Share of associates and joint
ventures
realised profits on disposal
of equity
investments
|
|
|
|
|
2
|
|
(2)
|
|
|
|
|
|
-
|
Share issued
|
1
|
|
7
|
|
|
|
|
|
8
|
|
|
|
8
|
Write-down of shares held by ESOP
Trusts
|
|
|
|
|
(48)
|
|
48
|
|
|
|
|
|
-
|
Shares acquired by ESOP
Trusts
|
|
|
2
|
|
1
|
|
(3)
|
|
|
|
|
|
-
|
Share-based incentive
plans
|
|
|
|
|
79
|
|
|
|
79
|
|
|
|
79
|
Hedging gain/(loss) after
taxation
transferred to non-financial
assets
|
|
|
|
|
|
|
(2)
|
|
(2)
|
|
|
|
(2)
|
At 31 March 2023
|
1,348
|
|
3,449
|
|
5,655
|
|
1,368
|
|
11,820
|
|
(508)
|
|
11,312
|
|
Cash flow statement three months
ended 31 March 2024
|
|
|
|
|
|
Q1 2024
£m
|
|
Q1 2023
£m
|
Profit after tax
|
1,081
|
|
1,631
|
|
|
|
|
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
|
|
|
|
Decrease/(increase) in working
capital
|
|
|
|
Contingent consideration
paid
|
|
|
|
Decrease in other net liabilities
(excluding contingent consideration paid)
|
|
|
|
Cash generated from
operations
|
1,126
|
|
287
|
|
|
|
|
Total net cash inflow/(outflow)
from operating activities
|
958
|
|
53
|
|
|
|
|
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
|
|
|
|
Contingent consideration
paid
|
|
|
|
|
|
|
|
|
|
|
|
Decrease/(Increase) 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
|
(149)
|
|
(408)
|
|
|
|
|
Cash flow from financing
activities
|
|
|
|
|
|
|
|
Repayment of long-term
loans
|
|
|
|
Net increase/(repayment) of other
short-term loans
|
|
|
|
Repayment of lease
liabilities
|
|
|
|
|
|
|
|
Dividends paid to
shareholders
|
|
|
|
Shares acquired by ESOP
Trusts
|
-
|
|
(2)
|
Distribution to non-controlling
interests
|
|
|
|
Contributions from non-controlling
interests
|
|
|
|
|
|
|
|
Total net cash inflow/(outflow)
from financing activities
|
(1,060)
|
|
(318)
|
Increase/(decrease) in cash and
bank overdrafts in the period
|
(251)
|
|
(673)
|
Cash and bank overdrafts at
beginning of the period
|
2,858
|
|
3,425
|
Exchange adjustments
|
(19)
|
|
(31)
|
Increase/(decrease) in cash and bank
overdrafts
|
(251)
|
|
(673)
|
Cash and bank overdrafts at end of
the period
|
2,588
|
|
2,721
|
Cash and bank overdrafts at end of
the period comprise:
|
|
|
|
Cash and cash equivalents
|
2,790
|
|
2,890
|
Overdrafts
|
(202)
|
|
(169)
|
|
2,588
|
|
2,721
|
|
Vaccines turnover - three months
ended 31 March 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
US
|
|
Europe
|
|
International
|
|
|
|
Growth
|
|
|
|
Growth
|
|
|
|
Growth
|
|
|
|
Growth
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
Shingles
|
945
|
|
13
|
|
18
|
|
470
|
|
(7)
|
|
(4)
|
|
229
|
|
7
|
|
9
|
|
246
|
|
>100
|
|
>100
|
Shingrix
|
945
|
|
13
|
|
18
|
|
470
|
|
(7)
|
|
(4)
|
|
229
|
|
7
|
|
9
|
|
246
|
|
>100
|
|
>100
|
Meningitis
|
299
|
|
7
|
|
11
|
|
121
|
|
2
|
|
6
|
|
101
|
|
(12)
|
|
(10)
|
|
77
|
|
67
|
|
74
|
Bexsero
|
217
|
|
-
|
|
3
|
|
72
|
|
(3)
|
|
1
|
|
98
|
|
(11)
|
|
(8)
|
|
47
|
|
38
|
|
41
|
Menveo
|
80
|
|
36
|
|
41
|
|
49
|
|
9
|
|
13
|
|
2
|
|
(50)
|
|
(50)
|
|
29
|
|
>100
|
|
>100
|
Other
|
2
|
|
(33)
|
|
-
|
|
-
|
|
-
|
|
-
|
|
1
|
|
-
|
|
-
|
|
1
|
|
(50)
|
|
-
|
RSV
|
182
|
|
-
|
|
-
|
|
154
|
|
-
|
|
-
|
|
1
|
|
-
|
|
-
|
|
27
|
|
-
|
|
-
|
Arexvy
|
182
|
|
-
|
|
-
|
|
154
|
|
-
|
|
-
|
|
1
|
|
-
|
|
-
|
|
27
|
|
-
|
|
-
|
Influenza
|
13
|
|
8
|
|
8
|
|
2
|
|
>100
|
|
>100
|
|
-
|
|
-
|
|
-
|
|
11
|
|
-
|
|
-
|
Fluarix, FluLaval
|
13
|
|
8
|
|
8
|
|
2
|
|
>100
|
|
>100
|
|
-
|
|
-
|
|
-
|
|
11
|
|
-
|
|
-
|
Established Vaccines
|
838
|
|
3
|
|
7
|
|
331
|
|
(6)
|
|
(3)
|
|
178
|
|
(8)
|
|
(6)
|
|
329
|
|
22
|
|
28
|
Infanrix, Pediarix
|
145
|
|
(18)
|
|
(15)
|
|
87
|
|
(19)
|
|
(16)
|
|
31
|
|
(6)
|
|
(6)
|
|
27
|
|
(25)
|
|
(22)
|
Boostrix
|
138
|
|
(1)
|
|
3
|
|
85
|
|
(8)
|
|
(3)
|
|
33
|
|
6
|
|
10
|
|
20
|
|
25
|
|
25
|
Hepatitis
|
175
|
|
3
|
|
6
|
|
91
|
|
(7)
|
|
(4)
|
|
51
|
|
11
|
|
13
|
|
33
|
|
27
|
|
35
|
Rotarix
|
154
|
|
12
|
|
17
|
|
57
|
|
21
|
|
26
|
|
29
|
|
(12)
|
|
(9)
|
|
68
|
|
17
|
|
24
|
Synflorix
|
45
|
|
(27)
|
|
(24)
|
|
-
|
|
-
|
|
-
|
|
2
|
|
(75)
|
|
(75)
|
|
43
|
|
(20)
|
|
(17)
|
Priorix, Priorix Tetra,
Varilrix
|
78
|
|
47
|
|
53
|
|
6
|
|
>100
|
|
>100
|
|
29
|
|
(12)
|
|
(9)
|
|
43
|
|
>100
|
|
>100
|
Cervarix
|
32
|
|
19
|
|
26
|
|
-
|
|
-
|
|
-
|
|
4
|
|
(56)
|
|
(56)
|
|
28
|
|
56
|
|
67
|
Other
|
71
|
|
45
|
|
47
|
|
5
|
|
(17)
|
|
(33)
|
|
(1)
|
|
>(100)
|
|
>(100)
|
|
67
|
|
56
|
|
63
|
Vaccines excluding
COVID-19
solutions
|
2,277
|
|
17
|
|
22
|
|
1,078
|
|
10
|
|
14
|
|
509
|
|
(2)
|
|
-
|
|
690
|
|
58
|
|
66
|
Pandemic vaccines
|
-
|
|
>(100)
|
|
>(100)
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(100)
|
|
(100)
|
|
-
|
|
-
|
|
-
|
Pandemic adjuvant
|
-
|
|
>(100)
|
|
>(100)
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(100)
|
|
(100)
|
|
-
|
|
-
|
|
-
|
Vaccines
|
2,277
|
|
12
|
|
16
|
|
1,078
|
|
10
|
|
14
|
|
509
|
|
(18)
|
|
(17)
|
|
690
|
|
58
|
|
66
|
|
Specialty Medicines turnover - three
months ended 31 March 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
US
|
|
Europe
|
|
International
|
|
|
|
Growth
|
|
|
|
Growth
|
|
|
|
Growth
|
|
|
|
Growth
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
HIV
|
1,613
|
|
10
|
|
14
|
|
1,031
|
|
12
|
|
17
|
|
364
|
|
5
|
|
7
|
|
218
|
|
6
|
|
15
|
Dolutegravir products
|
1,304
|
|
2
|
|
6
|
|
772
|
|
2
|
|
5
|
|
324
|
|
2
|
|
3
|
|
208
|
|
5
|
|
14
|
Tivicay
|
354
|
|
(1)
|
|
4
|
|
186
|
|
1
|
|
4
|
|
64
|
|
(3)
|
|
(2)
|
|
104
|
|
(2)
|
|
8
|
Triumeq
|
310
|
|
(17)
|
|
(14)
|
|
211
|
|
(15)
|
|
(12)
|
|
59
|
|
(21)
|
|
(20)
|
|
40
|
|
(20)
|
|
(16)
|
Juluca
|
157
|
|
5
|
|
8
|
|
122
|
|
10
|
|
14
|
|
32
|
|
(9)
|
|
(6)
|
|
3
|
|
(25)
|
|
(25)
|
Dovato
|
483
|
|
22
|
|
27
|
|
253
|
|
18
|
|
22
|
|
169
|
|
18
|
|
20
|
|
61
|
|
61
|
|
74
|
Rukobia
|
33
|
|
32
|
|
36
|
|
31
|
|
35
|
|
39
|
|
2
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
Cabenuva
|
213
|
|
68
|
|
73
|
|
171
|
|
66
|
|
73
|
|
35
|
|
75
|
|
80
|
|
7
|
|
75
|
|
50
|
Apretude
|
54
|
|
>100
|
|
>100
|
|
54
|
|
>100
|
|
>100
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
Other
|
9
|
|
(40)
|
|
(27)
|
|
3
|
|
(57)
|
|
(43)
|
|
3
|
|
(40)
|
|
(40)
|
|
3
|
|
-
|
|
33
|
Respiratory/Immunology
and Other
|
635
|
|
6
|
|
11
|
|
378
|
|
(4)
|
|
-
|
|
132
|
|
22
|
|
25
|
|
125
|
|
25
|
|
37
|
Nucala
|
374
|
|
8
|
|
13
|
|
180
|
|
(5)
|
|
(2)
|
|
109
|
|
22
|
|
26
|
|
85
|
|
23
|
|
36
|
Benlysta
|
260
|
|
3
|
|
8
|
|
198
|
|
(3)
|
|
1
|
|
27
|
|
17
|
|
22
|
|
35
|
|
35
|
|
46
|
Other
|
1
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(4)
|
|
-
|
|
(25)
|
|
5
|
|
-
|
|
-
|
Oncology
|
273
|
|
>100
|
|
>100
|
|
186
|
|
>100
|
|
>100
|
|
75
|
|
4
|
|
6
|
|
12
|
|
33
|
|
33
|
Zejula
|
141
|
|
24
|
|
27
|
|
72
|
|
44
|
|
50
|
|
58
|
|
5
|
|
7
|
|
11
|
|
22
|
|
22
|
Blenrep
|
-
|
|
(100)
|
|
>(100)
|
|
(1)
|
|
-
|
|
-
|
|
1
|
|
(91)
|
|
(91)
|
|
-
|
|
-
|
|
-
|
Jemperli
|
80
|
|
>100
|
|
>100
|
|
65
|
|
>100
|
|
>100
|
|
14
|
|
>100
|
|
>100
|
|
1
|
|
-
|
|
100
|
Ojjaara
|
52
|
|
-
|
|
-
|
|
50
|
|
-
|
|
-
|
|
2
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
Other
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
Specialty Medicines
excluding
COVID-19
solutions
|
2,521
|
|
14
|
|
19
|
|
1,595
|
|
17
|
|
21
|
|
571
|
|
9
|
|
11
|
|
355
|
|
13
|
|
23
|
Pandemic
|
1
|
|
(97)
|
|
(97)
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
1
|
|
(97)
|
|
(97)
|
Xevudy
|
1
|
|
(97)
|
|
(97)
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
1
|
|
(97)
|
|
(97)
|
Specialty Medicines
|
2,522
|
|
13
|
|
17
|
|
1,595
|
|
17
|
|
21
|
|
571
|
|
9
|
|
11
|
|
356
|
|
3
|
|
12
|
|
General Medicines turnover - three
months ended 31 March 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Respiratory
|
1,725
|
|
(2)
|
|
2
|
|
863
|
|
4
|
|
8
|
|
361
|
|
(3)
|
|
(1)
|
|
501
|
|
(11)
|
|
(4)
|
Anoro Ellipta
|
119
|
|
(1)
|
|
3
|
|
44
|
|
(14)
|
|
(10)
|
|
52
|
|
13
|
|
15
|
|
23
|
|
-
|
|
4
|
Flixotide/Flovent
|
139
|
|
(11)
|
|
(8)
|
|
95
|
|
(10)
|
|
(8)
|
|
18
|
|
(14)
|
|
(10)
|
|
26
|
|
(13)
|
|
(10)
|
Relvar/Breo Ellipta
|
270
|
|
(1)
|
|
4
|
|
99
|
|
(1)
|
|
2
|
|
98
|
|
-
|
|
2
|
|
73
|
|
(4)
|
|
8
|
Seretide/Advair
|
282
|
|
(17)
|
|
(13)
|
|
92
|
|
(23)
|
|
(21)
|
|
61
|
|
(14)
|
|
(13)
|
|
129
|
|
(13)
|
|
(6)
|
Trelegy Ellipta
|
591
|
|
27
|
|
33
|
|
425
|
|
30
|
|
35
|
|
75
|
|
12
|
|
13
|
|
91
|
|
28
|
|
41
|
Ventolin
|
168
|
|
(18)
|
|
(15)
|
|
86
|
|
(20)
|
|
(17)
|
|
25
|
|
(11)
|
|
(7)
|
|
57
|
|
(17)
|
|
(14)
|
Other Respiratory
|
156
|
|
(25)
|
|
(20)
|
|
22
|
|
10
|
|
20
|
|
32
|
|
(22)
|
|
(22)
|
|
102
|
|
(30)
|
|
(25)
|
Other General Medicines
|
839
|
|
(7)
|
|
(2)
|
|
53
|
|
(42)
|
|
(41)
|
|
180
|
|
(2)
|
|
1
|
|
606
|
|
(4)
|
|
2
|
Augmentin
|
186
|
|
5
|
|
10
|
|
-
|
|
-
|
|
-
|
|
54
|
|
(4)
|
|
(2)
|
|
132
|
|
9
|
|
16
|
Lamictal
|
101
|
|
(22)
|
|
(19)
|
|
37
|
|
(44)
|
|
(42)
|
|
28
|
|
-
|
|
4
|
|
36
|
|
3
|
|
9
|
Other "Other General
Medicines"
|
552
|
|
(8)
|
|
(3)
|
|
16
|
|
(38)
|
|
(38)
|
|
98
|
|
(1)
|
|
1
|
|
438
|
|
(8)
|
|
(1)
|
General Medicines
|
2,564
|
|
(4)
|
|
1
|
|
916
|
|
(1)
|
|
3
|
|
541
|
|
(3)
|
|
(1)
|
|
1,107
|
|
(7)
|
|
(1)
|
|
|
|
|
|
Commercial Operations
turnover
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
|
£m
|
|
£%
|
|
CER%
|
Three months ended 31 March
2024
|
7,363
|
|
6
|
|
10
|
|
3,589
|
|
10
|
|
14
|
|
1,621
|
|
(5)
|
|
(3)
|
|
2,153
|
|
9
|
|
16
|
|
|
|
|
|
Commercial Operations turnover
excluding COVID-19 solutions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended 31 March
2024
|
7,362
|
|
8
|
|
13
|
|
3,589
|
|
10
|
|
14
|
|
1,621
|
|
1
|
|
3
|
|
2,152
|
|
11
|
|
18
|
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.
|
|
|
|
|
|
|
|
Turnover by segment
|
|
Q1 2024
£m
|
|
Q1 2023
£m
|
|
Growth
£%
|
|
Growth
CER%
|
|
|
|
|
|
|
|
|
Commercial Operations (total
turnover)
|
7,363
|
|
6,951
|
|
6
|
|
10
|
|
|
|
|
|
|
|
|
Operating profit by
segment
|
|
Q1 2024
£m
|
|
Q1 2023
£m
|
|
Growth
£%
|
|
Growth
CER%
|
|
|
|
|
|
|
|
|
Commercial Operations
|
3,855
|
|
3,375
|
|
14
|
|
21
|
Research and Development
|
(1,308)
|
|
(1,232)
|
|
6
|
|
9
|
|
|
|
|
|
|
|
|
Segment profit
|
2,547
|
|
2,143
|
|
19
|
|
28
|
Corporate and other unallocated
costs
|
(104)
|
|
(51)
|
|
|
|
|
|
|
|
|
|
|
|
|
Core operating profit
|
2,443
|
|
2,092
|
|
17
|
|
27
|
Adjusting items
|
(953)
|
|
(10)
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating profit
|
1,490
|
|
2,082
|
|
(28)
|
|
(18)
|
|
|
|
|
|
|
|
|
Finance income
|
32
|
|
29
|
|
|
|
|
Finance costs
|
(166)
|
|
(203)
|
|
|
|
|
Share of after tax profit/(loss) of
associates and
joint ventures
|
(1)
|
|
(2)
|
|
|
|
|
Profit/(loss) on disposal of
associates and joint ventures
|
-
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit before taxation
|
1,355
|
|
1,907
|
|
(29)
|
|
(18)
|
Commercial Operations Core
operating profit of £3,855 million grew in the quarter driven by
strong sales and a favourable product mix and a reversal of
the Zejula royalty dispute legal provision, partly offset by disciplined
investment in growth assets and lower royalty income.
The R&D segment operating
expenses of £1,308 million, grew in the quarter driven by
continued investment across disease areas including late stage
investment in Vaccines, Respiratory/Immunology and Infectious
Diseases, including pneumococcal and mRNA programmes, and
camlipixant. This was partly offset by decreases related to the
completion of late-stage clinical development programmes including
RSV and momelotinib, and reduced investment in Zejula versus Q1 2023. In the
quarter restructuring of the research division was broadly
completed, with the charge being taken in Q4 2023.
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 31 March 2024, the Group's aggregate provision for legal
and other disputes (not including tax matters described on page 10)
was £312 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 Annual Report 2023:
Intellectual Property
RSV
The United States District Court
for the District of Delaware has set a trial date of 3 August 2026
in the suit against Pfizer Inc. alleging infringement of US GSK
patents by Pfizer's RSV vaccine, ABRYSVO.
mRNA
On 25 April 2024, GSK filed a
patent infringement suit against Pfizer Inc. and BioNTech SE in the
United States District Court for the District of Delaware alleging
infringement of five US GSK patents by the COVID-19 vaccine,
COMIRNATY.
Product Liability
Zantac
The Delaware Superior Court held a
hearing regarding admissibility of expert testimony as to general
causation on 22-24 January 2024. The parties continue to
await a ruling from the Court, which will relate only to the
admissibility of evidence and not to the determination of liability
or to the merits of the underlying claims.
As announced on 29 February 2024,
GSK reached a confidential settlement in the Boyd/Steenvoord case
filed in California state court. The case, which was set to begin
trial on 2 April 2024, will be dismissed. The settlement reflects
the company's desire to avoid the distraction related to protracted
litigation in this case. GSK did not admit any liability in the
settlement and will continue to vigorously defend itself based on
the facts and the science in all other Zantac cases.
In the California Judicial Council
Coordination Proceedings (JCCP), the Court has scheduled a Sargon
hearing for 6-7 June 2024 for eight cases, including two bellwether
cases (Hughes and Caratti, cases alleging colorectal and bladder
cancer, respectively). The Court has set a trial date for the
Hughes case of 8 July 2024, with Caratti to receive a trial date
only after the Hughes trial concludes. The other six cases do not
have trial dates pending their transfer to other counties in
California. A separate Sargon hearing for a further 12 cases has
been set for 15 August 2024. The Court has also ordered the parties
to work up 350 cases for trial.
Trial dates have also been set in
other state courts. In Illinois, the first case scheduled for trial
(Valadez, a case alleging colorectal cancer) began on 30 April 2024
and is expected to last around four weeks. The second Illinois case
(Williams, a case alleging lung cancer) is scheduled for trial on
23 May 2024. Three other cases have trial dates in Illinois ahead
of the expected publication date of GSK's results for Q2 2024
(Gross and Kasza, cases alleging prostate and breast cancer,
respectively on 5 June 2024 and Kimbrow, a case alleging prostate
cancer, on 12 July 2024). On 16 April 2024, the Illinois court
issued a Frye ruling in Valadez, finding that the plaintiff's
experts' causation opinions are admissible and can be presented to
a jury. The single case in Texas is set for trial on 21
October 2024 and one case in Nevada is scheduled for trial on 3
March 2025.
Given the current stage of the
proceedings, GSK cannot meaningfully assess what liability, if any,
it may have, nor can it meaningfully assess the liability of other
parties under relevant indemnification provisions.
Returns to shareholders
Quarterly dividends
The Board has declared a first
interim dividend for Q1 2024 of 15p per share (Q1 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 Q1 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 9 July 2024. An annual fee of $0.03 per ADS (or $0.0075 per
ADS per quarter) is charged by the Depositary. The ex-dividend date
will be 16 May 2024, with a record date of 17 May 2024 and a
payment date of 11 July 2024.
|
|
|
|
|
|
|
Paid/
Payable
|
|
Pence per
share
|
|
£m
|
|
|
|
|
|
|
2024
|
|
|
|
|
|
First interim
|
11 July 2024
|
|
15
|
|
612
|
|
|
|
|
|
|
2023
|
|
|
|
|
|
First interim
|
13 July 2023
|
|
14
|
|
567
|
Second interim
|
12 October 2023
|
|
14
|
|
568
|
Third interim
|
11 January 2024
|
|
14
|
|
568
|
Fourth interim
|
11 April 2024
|
|
16
|
|
652
|
|
|
|
|
|
|
|
|
|
58
|
|
2,355
|
Share capital in issue
At 31 March 2024, 4,078 million
shares (Q1 2023: 4,052 million) were in free issue (excluding
Treasury shares and shares held by the ESOP Trusts). No Treasury
shares have been repurchased since 2014. The company issued 1.9
million shares under employee share schemes in the year for
proceeds of £18 million (Q1 2023: £8 million).
At 31 March 2024, the ESOP Trusts
held 66.9 million shares of GSK shares, of which 66.6 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 £611 million has been deducted from
other reserves. The market value of these shares was
£1,144 million.
At 31 March 2024, the company held
169 million Treasury shares at a cost of £2,957 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:
|
|
|
|
|
|
|
|
|
Q1 2024
millions
|
|
Q1 2023
millions
|
|
|
|
|
|
|
Weighted average number of shares -
basic
|
|
|
4,069
|
|
4,044
|
Dilutive effect of share options and
share awards
|
|
|
44
|
|
41
|
|
|
|
|
|
|
Weighted average number of shares -
diluted
|
|
|
4,113
|
|
4,085
|
Additional information
Accounting policies and basis of
preparation
This unaudited Results
Announcement contains condensed financial information for the three
months ended 31 March 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:
|
|
|
|
|
|
|
|
|
Q1 2024
|
|
Q1 2023
|
|
2023
|
|
|
|
|
|
|
Average rates:
|
|
|
|
|
|
|
|
US$/£
|
1.27
|
|
1.22
|
|
1.24
|
|
|
Euro/£
|
1.16
|
|
1.14
|
|
1.15
|
|
|
Yen/£
|
187
|
|
162
|
|
175
|
|
|
|
|
|
|
Period-end rates:
|
|
|
|
|
|
|
|
US$/£
|
1.26
|
|
1.24
|
|
1.27
|
|
|
Euro/£
|
1.17
|
|
1.14
|
|
1.15
|
|
|
Yen/£
|
191
|
|
165
|
|
180
|
Contingent liabilities
There were contingent liabilities
at 31 March 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 32 and pages 263 to 266 of the 2023 Annual
Report.
Net assets
The book value of net assets
increased by £434 million from £12,795 million at 31 December 2023
to £13,229 million at 31 March 2024. This primarily reflected
contribution from Total comprehensive income for the period partly
offset by dividends paid to shareholders.
At 31 March 2024, the net deficit
on the Group's pension plans was £721 million compared with £764
million at 31 December 2023. This decrease in the net deficit is
primarily due to increases in the UK and US discount rates, as well
as experience adjustments, partially offset by lower UK asset
values and an increase to the US cash balance credit
rate.
The estimated present value of the
potential redemption amount of the Pfizer put option related to
ViiV Healthcare, recorded in Other payables in Current liabilities,
was £914 million (31 December 2023: £848 million).
Contingent consideration amounted
to £7,075 million at 31 March 2024 (31 December 2023: £6,662
million), of which £6,004 million (31 December 2023: £5,718
million) represented the estimated present value of amounts payable
to Shionogi relating to ViiV Healthcare, £446 million (31 December
2023: £423 million) represented the estimated present value of
contingent consideration payable to Novartis related to the
Vaccines acquisition, £527 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 31 March 2024, £1,057 million
(31 December 2023: £1,017 million) is expected to be paid within
one year.
Movements in contingent
consideration are as follows:
|
|
|
|
Q1 2024
|
ViiV
Healthcare
£m
|
|
Group
£m
|
|
|
|
|
Contingent consideration at
beginning of the period
|
5,718
|
|
6,662
|
Remeasurement through income
statement and other movements
|
586
|
|
722
|
Cash payments: operating cash
flows
|
(300)
|
|
(306)
|
Cash payments: investing
activities
|
-
|
|
(3)
|
|
|
|
|
Contingent consideration at end of
the period
|
6,004
|
|
7,075
|
|
|
|
|
Q1 2023
|
ViiV
Healthcare
£m
|
|
Group
£m
|
|
|
|
|
Contingent consideration at
beginning of the period
|
5,890
|
|
7,068
|
Remeasurement through income
statement and other movements
|
(64)
|
|
(193)
|
Cash payments: operating cash
flows
|
(287)
|
|
(290)
|
Cash payments: investing
activities
|
-
|
|
(1)
|
|
|
|
|
Contingent consideration at end of
the period
|
5,539
|
|
6,584
|
Business acquisitions
On 9 January 2024, GSK announced
it had entered into an agreement to acquire 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 initial acquisition accounting
was reflected in the first quarter of 2024 on a preliminary basis,
the values below are provisional and subject to change. The
purchase price allocation is expected to be completed by the end of
Q4 2024.
The provisional fair values of the
net assets acquired, including goodwill, are as follows:
|
|
|
|
|
|
|
£m
|
|
|
|
|
Net assets acquired:
|
|
|
|
Intangible assets
|
|
|
927
|
Cash and cash equivalents
|
|
|
23
|
Other net liabilities
|
|
|
(16)
|
Deferred tax liabilities
|
|
|
(197)
|
|
|
|
|
|
|
|
737
|
Goodwill
|
|
|
159
|
|
|
|
|
Total consideration
|
|
|
896
|
|
|
|
|
|
Of the £896 million consideration,
£154 million was unpaid as at 31 March 2024.
|
|
Reconciliation of cash flow to
movements in net debt
|
|
|
|
|
|
Q1 2024
£m
|
|
Q1 2023
£m
|
|
|
|
|
Total Net debt at beginning of the
period
|
(15,040)
|
|
(17,197)
|
|
|
|
|
Increase/(decrease) in cash and bank
overdrafts
|
(251)
|
|
(673)
|
(Increase)/decrease in liquid
investments
|
(22)
|
|
-
|
Net increase/(repayment) of other
short-term loans
|
323
|
|
(552)
|
Repayment of long-term
notes
|
-
|
|
144
|
Repayment of lease
liabilities
|
57
|
|
47
|
Exchange adjustments
|
1
|
|
322
|
Other non-cash movements
|
(29)
|
|
(41)
|
|
|
|
|
Decrease/(increase) in net
debt
|
79
|
|
(753)
|
Total Net debt at end of the
period
|
(14,961)
|
|
(17,950)
|
|
|
|
|
|
31 March 2024
£m
|
|
31 December 2023
£m
|
|
|
|
|
Liquid investments
|
21
|
|
42
|
Cash and cash equivalents
|
2,790
|
|
2,936
|
Short-term borrowings
|
(2,616)
|
|
(2,813)
|
Long-term borrowings
|
(15,156)
|
|
(15,205)
|
|
|
|
|
Total Net debt at the end of the
period
|
(14,961)
|
|
(15,040)
|
|
Free cash flow
reconciliation
|
|
|
|
|
|
Q1 2024
£m
|
|
Q1 2023
£m
|
|
|
|
|
Net cash inflow/(outflow) from
operating activities
|
958
|
|
53
|
Purchase of property, plant and
equipment
|
(248)
|
|
(233)
|
Proceeds from sale of property,
plant and equipment
|
1
|
|
7
|
Purchase of intangible
assets
|
(315)
|
|
(296)
|
Proceeds from disposals of
intangible assets
|
27
|
|
4
|
Net finance costs
|
(34)
|
|
(91)
|
Dividends and disposal proceeds from
associates and joint ventures
|
-
|
|
1
|
Contingent consideration paid
(reported in investing activities)
|
(3)
|
|
(1)
|
Distributions to non-controlling
interests
|
(97)
|
|
(140)
|
Contributions from non-controlling
interests
|
-
|
|
7
|
|
|
|
|
Free cash
inflow/(outflow)
|
289
|
|
(689)
|
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 (50-59 years of
age)
|
•
|
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)
|
|
|
•
|
Ojjaara (JAK1, JAK2 and ACVR1 inhibitor) myelofibrosis with
anaemia
|
|
|
|
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
|
|
|
|
cobolimab (anti-TIM-3) 2L non-small
cell lung cancer
|
|
|
|
|
Total vaccines and medicines in all
phases of clinical development
|
72
|
|
|
Total projects in clinical
development (inclusive of all phases and indications)
|
91
|
|
|
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)
The US Food and Drug
Administration (FDA) accepted under Priority Review an application
to extend the indication of GSK's adjuvanted respiratory syncytial
virus (RSV) vaccine to adults aged 50-59 who are at increased risk
for RSV disease. If approved, GSK's RSV vaccine would be the first
vaccine available to help protect this population.
Arexvy is currently
approved in the US in adults aged 60 and over for the prevention of
lower respiratory tract disease (LRTD) caused by RSV.
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
|
Active, not recruiting; 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
|
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
|
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
|
Active, not recruiting; 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
|
Active, not recruiting
|
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
Data anticipated: 2025
|
Active, recruiting
|
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
Data anticipated:
H2 2024
|
Active, not recruiting
|
bepirovirsen (HBV ASO)
Bepirovirsen, a triple-action
antisense oligonucleotide, is a potential new treatment option for
people with chronic hepatitis B (CHB). In February 2024, the US FDA
granted Fast Track designation for bepirovirsen for the treatment
of CHB. Fast Track designation is intended to facilitate the
development and expedite the review of medicines to treat serious
conditions and fill an unmet medical need. To further expand
development in novel sequential regimens, GSK has entered an
agreement for an exclusive worldwide license to develop and
commercialise daplusiran/tomligisiran (GSK5637608, formerly
JNJ-3989), an investigational hepatitis B virus-targeted small
interfering ribonucleic acid (siRNA) therapeutic. This agreement
provides an opportunity to investigate a novel sequential regimen
to pursue functional cure in an even broader patient population
with bepirovirsen.
Key trials for
bepirovirsen:
|
|
|
|
|
Trial name (population)
|
Phase
|
Design
|
Timeline
|
Status
|
B-Well 1 bepirovirsen in
nucleos(t)ide treated patients (chronic hepatitis B)
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+
|
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+
|
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: 2025
|
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). In February 2024, positive headline results were announced
from the pivotal EAGLE-1 phase III trial for gepotidacin showing
the primary endpoint was met. Gepotidacin achieved a 92.6%
microbiological success rate compared to a 91.2% success rate of
intramuscular ceftriaxone plus oral azithromycin combined therapy
(a leading combination treatment regimen for gonorrhoea),
demonstrating non-inferiority. Safety and tolerability data were
consistent with results seen in gepotidacin phase I and II trials.
The data were presented at the 2024 European Society of Clinical
Microbiology and Infectious Diseases (ESCMID) Global in April
2024.
EAGLE-1 is the third positive
pivotal trial for gepotidacin and demonstrates its potential to
provide a new oral treatment option for patients given the rising
incidence of gonorrhoea worldwide, including drug resistant
infections.
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
The US FDA accepted a Biologics
License Application (BLA) for GSK's 5-in-1 meningococcal ABCWY
(MenABCWY) vaccine candidate on 16 April 2024 and set a
Prescription Drug User Fee Act (PDUFA) action date of 14 February
2025. GSK's 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.
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
|
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
cabotegravir
GSK continues to advance its
early-stage HIV pipeline focused on innovative long-acting
injectable regimens and expects cabotegravir to increasingly
replace dolutegravir as the foundational integrase inhibitor in its
portfolio by the second half of the decade. In February 2024, ViiV
Healthcare announced results from an interim analysis of the
LATITUDE phase III trial after the trial's Data Safety Monitoring
Board recommended it be modified to stop randomisation and give
participants receiving daily oral therapy the option to transition
to long-acting injectable therapy. Results indicated that
long-acting injectable antiretroviral treatment (ART) for
HIV, Cabenuva (cabotegravir + rilpirivine), demonstrated superior efficacy
in maintaining viral load suppression compared to daily oral
therapy in individuals with a history of ART adherence
challenges.
In March 2024, ViiV Healthcare
presented 64 abstracts at the Conference on Retroviruses and
Opportunistic Infections (CROI), in Denver, Colorado, including
highlights of the company's next-generation pipeline advancements
and data from its diverse portfolio of marketed HIV treatment and
prevention options. Detailed results from the LATITUDE trial were
presented, together with positive findings from a phase I study
showing that an investigational formulation of cabotegravir, known
as cabotegravir ultra long-acting (CAB-ULA), can be dosed at
intervals of at least four months. This is the company's first step
towards delivering ultra long-acting injectable HIV treatment and
prevention medicines that would potentially enable people to have
at least four months between visits to the clinic.
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:
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:
2025
|
Recruiting
|
depemokimab (long acting
anti-IL5)
Depemokimab is in late stage
development for severe asthma, chronic rhinosinusitis with nasal
polyps (CRSwNP), hypereosinophilic syndrome (HES) and eosinophilic
granulomatosis with polyangiitis (EGPA). Depemokimab is the first
and only next-generation ultra-long-acting biologic engineered to
have enhanced binding affinity and high potency for IL-5, resulting
in an extended half-life and enabling dosing every six
months.
The phase III programme for
depemokimab continues to make progress across a range of IL-5
mediated conditions with phase III data expected to begin reading
out in H1 2024.
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 anticipated:
H1 2024
|
Active, not recruiting
|
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 anticipated:
H1 2024
|
Active, not recruiting
|
|
Key phase III trials for depemokimab
continued:
|
|
|
|
|
|
Trial name (population)
|
Phase
|
Design
|
Timeline
|
Status
|
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:
2025
|
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:
2025
|
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 anticipated:
H2 2024
|
Active, not recruiting
|
ANCHOR-2 (CRSwNP)
NCT05281523
|
III
|
Efficacy and safety of depemokimab
in participants with CRSwNP
|
Trial start:
Q2 2022
Data anticipated:
H2 2024
|
Active, not recruiting
|
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:
2025
|
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. It been studied in over
4,000 patients in 41 clinical trials across several IL-5 mediated
conditions. Nucala is the only treatment approved for use in the US and Europe,
across four IL-5 medicated conditions: severe asthma with an
eosinophilic phenotype, EGPA, HES and CRSwNP.
The MATINEE phase III trial
investigating Nucala in patients with chronic obstructive pulmonary disease (COPD)
is expected to readout in the second half of 2024.
Key phase trials for
Nucala:
|
|
|
|
|
Trial name (population)
|
Phase
|
Design
|
Timeline
|
Status
|
MATINEE (chronic obstructive
pulmonary disease; COPD)
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 anticipated:
H2 2024
|
Active, not recruiting
|
Oncology
Blenrep (belantamab mafodotin)
In February 2024, GSK presented
positive results from the DREAMM-7 phase III head-to-head trial
evaluating belantamab mafodotin as a second-line or later treatment
for relapsed or refractory multiple myeloma at the American Society
of Clinical Oncology (ASCO) Plenary Series. The trial met its
primary endpoint of progression-free survival (PFS), with a
statistically significant and clinically meaningful 59%
reduction in risk of disease progression or death observed in
patients with belantamab mafodotin combined with bortezomib plus
dexamethasone (BorDex) versus standard of care, daratumumab plus
BorDex. A median PFS of 36.6 months was observed with the
belantamab mafodotin combination versus 13.4 months with the
daratumumab combination. The belantamab mafodotin combination also
resulted in clinically meaningful improvements in all secondary
efficacy endpoints including a doubling of complete response rate
(stringent complete response plus complete response), minimal
residual disease negativity rate and median duration of response. A
strong and clinically meaningful overall survival (OS) trend was
observed at the interim analysis, with a 43% reduction in the risk
of death. OS follow-up continues and further analyses are
planned.
In March 2024, GSK announced
positive headline results from a planned interim analysis of the
DREAMM-8 phase III head-to-head trial evaluating belantamab
mafodotin, in combination with pomalidomide plus dexamethasone
(PomDex), versus a standard of care, bortezomib plus PomDex, as a
second line and later treatment for relapsed or refractory multiple
myeloma. The trial met its primary endpoint of PFS, with the
belantamab mafodotin combination significantly extending the time
to disease progression or death versus the standard of care
combination. A positive OS trend favouring the belantamab mafodotin
combination was also observed at the time of this analysis. The
trial continues to follow up for OS.
Results from DREAMM-8 will be
presented at ASCO 2024, and data from both DREAMM-7 and DREAMM-8
are being shared with health authorities.
The DREAMM (DRiving Excellence in
Approaches to Multiple Myeloma) clinical development programme
continues to evaluate the potential of belantamab mafodotin in
early lines of treatment and in combination with novel therapies
and standard of care treatments.
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
|
Active, not recruiting
|
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 is the foundation of GSK's ongoing immuno-oncology-based
research and development programme. It is currently approved in the
US and several other countries in a subset of adult patients with
primary advanced or recurrent endometrial cancer that is mismatch
repair deficient (dMMR), or microsatellite instability-high
(MSI-H). Efforts continue to generate data to support combination
therapies with dostarlimab as the backbone and expand use into a
broader population of patients.
In March 2024, GSK presented
statistically significant and clinically meaningful OS results from
Part 1 of the RUBY phase III trial in adult patients with primary
advanced or recurrent endometrial cancer at the Society of
Gynecologic Oncology 2024 Annual Meeting on Women's Cancer (SGO
2024). A 31% reduction in the risk of death and 16.4-month
improvement in median OS was observed with dostarlimab plus
chemotherapy versus chemotherapy in the overall population.
Dostarlimab plus chemotherapy is the only immuno-oncology
combination to show statistically significant and clinically
meaningful OS in patients with primary advanced or recurrent
endometrial cancer, regardless of biomarker status.
In April 2024, the US FDA accepted
under Priority Review a supplemental Biologics License Application
(sBLA) for Jemperli in combination with standard-of-care chemotherapy
(carboplatin and paclitaxel) for the treatment of adult patients
with primary advanced or recurrent endometrial cancer based on the
RUBY Part 1 data. The Prescription Drug User Fee Act action date is
23 August 2024. Approval of the sBLA would broaden the current
indication for Jemperli
plus chemotherapy to all adult patients with
primary advanced or recurrent endometrial cancer, including
patients with mismatch repair proficient (MMRp)/microsatellite
stable (MSS) tumours.
GSK also presented PFS results
from Part 2 of the RUBY phase III trial in primary advanced or
recurrent endometrial cancer at SGO 2024. In RUBY Part 2, a 37%
reduction in risk of disease progression or death and 6-month
improvement in median PFS was observed with the addition of
Zejula (niraparib) to
dostarlimab maintenance following dostarlimab plus chemotherapy
versus chemotherapy in patients with MMRp)/MSS tumours.
In March 2024, GSK began
recruiting for its phase III JADE clinical trial evaluating the
safety and effectiveness of dostarlimab in adult participants with
locally advanced unresectable head and neck squamous cell
carcinoma.
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
|
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:
Q2 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:
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
|
Ojjaara/Omjjaara
(momelotinib)
Following the September 2023
approval of Ojjaara by the US FDA and its authorisation as Omjjara by the European Commission
and the UK Medicines & Healthcare products Regulatory Agency
(MHRA) in January 2024, GSK continues to pursue regulatory
submissions and approvals in myelofibrosis across the globe,
including a new drug application under review in Japan. With its
differentiated mechanism of action, Ojjaara has the potential to become
a backbone therapy in myelofibrosis, and GSK continues to evaluate
its potential in combinations and other areas of unmet
need.
Key phase III trial for
momelotinib:
|
|
|
|
|
Trial name (population)
|
Phase
|
Design
|
Timeline
|
Status
|
MOMENTUM (myelofibrosis)
NCT04173494
|
III
|
A randomised, double-blind, active
control phase III trial intended to confirm the differentiated
clinical benefits of the investigational drug momelotinib (MMB)
versus danazol (DAN) in symptomatic and anaemic subjects who have
previously received an approved Janus kinase inhibitor (JAKi)
therapy for myelofibrosis (MF)
|
Trial start:
Q1 2020
Primary data reported:
Q1 2022
|
Complete; primary endpoint
met
|
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
combination studies, including the RUBY Part 2 phase III trial of
niraparib and dostarlimab, a programmed death receptor-1
(PD-1)-blocking antibody, in recurrent or primary advanced (stage
III or IV) endometrial cancer, for which positive results were
presented at the Society of Gynecologic Oncology 2024 Annual
Meeting on Women's Cancer in March 2024.
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
Total and Core results
Total reported results represent
the Group's overall performance. GSK uses a number of non-IFRS,
measures to report the performance of its business. Core results
and other non-IFRS measures may be considered in addition to, but
not as a substitute for or superior to, information presented in
accordance with IFRS. Core results are defined on page 18 and other
non-IFRS measures are defined below.
CER and AER growth
In order to illustrate underlying
performance, it is the Group's practice to discuss its results in
terms of constant exchange rate (CER) growth. This represents
growth calculated as if the exchange rates used to determine the
results of overseas companies in Sterling had remained unchanged
from those used in the comparative period. CER% represents growth
at constant exchange rates. For those countries which qualify as
hyperinflationary as defined by the criteria set out in IAS 29
'Financial Reporting in Hyperinflationary Economies' (Argentina and
Turkey) CER growth is adjusted using a more appropriate exchange
rate reflecting depreciation of their respective currencies in
order to provide comparability and not to distort CER growth
rates.
£% or AER% represents growth at
actual exchange rates.
Free cash flow
Free cash flow is defined as the
net cash inflow/outflow from operating activities less capital
expenditure on property, plant and equipment and intangible assets,
contingent consideration payments, net finance costs, and dividends
paid to non-controlling interests, contributions from
non-controlling interests plus proceeds from the sale of property,
plant and equipment and intangible assets, and dividends received
from joint ventures and associates. The measure is used by
management as it is considered a good indicator of net cash
generated from business activities (excluding any cash flows
arising from equity investments, business acquisitions or disposals
and changes in the level of borrowing) available to pay
shareholders dividends and to fund strategic plans. Free cash flow
growth is calculated on a reported basis. A reconciliation of net
cash inflow from operations to free cash flow from operations is
set out on page 37.
Free cash flow
conversion
Free cash flow conversion is free
cash flow from operations as a percentage of profit attributable to
shareholders.
Total Net debt
Net debt is defined as total
borrowings less cash, cash equivalents, liquid investments, and
short-term loans to third parties that are subject to an
insignificant risk of change in value. The measure is used by
management as it is considered a good indicator of GSK's ability to
meet its financial commitments and the strength of its balance
sheet.
COVID-19 solutions
COVID-19 solutions include the
sales of pandemic adjuvant and other COVID-19 solutions during the
years from 2020-2023 and includes vaccine manufacturing and
Xevudy and the
associated costs but does not include reinvestment in R&D. This
categorisation is used by management who believe it is helpful to
investors through providing clarity on the results of the Group by
showing the contribution to growth from COVID-19 solutions during
this period.
Turnover excluding COVID-19
solutions
Turnover excluding COVID-19
solutions excludes the impact of sales of pandemic adjuvant within
Vaccines and Xevudy within Specialty Medicines related to the COVID-19 pandemic
during the years 2020-2023. Management believes that the exclusion
of the impact of these COVID-19 solutions sales aids comparability
in the reporting periods and understanding of GSK's growth
including by region versus prior periods and also 2024 Guidance
which excludes any contributions from COVID-19 solutions in current
year or comparator periods.
Non-controlling
interest
Non-controlling interest is the
equity in a subsidiary not attributable, directly or indirectly, to
a parent.
Working capital
Working capital represents
inventory and trade receivables less trade payables.
Total Operating Margin
Total Operating margin is Total
operating profit divided by turnover.
Core Operating Margin
Core Operating margin is Core
operating profit divided by turnover.
Total Earnings per
share
Unless otherwise stated, Total
earnings per share refers to Total basic earnings per
share.
RAR (Returns and
Rebates)
GSK sells to customers both
commercial and government mandated contracts with reimbursement
arrangements that include rebates, chargebacks and a right of
return for certain pharmaceutical products principally in the US.
Revenue recognition reflects gross-to-net sales adjustments as a
result. These adjustments are known as the RAR accruals and are a
source of significant estimation uncertainty and fluctuation which
can have a material impact on reported revenue from one accounting
period to the next.
Risk adjusted sales
Pipeline risk-adjusted sales are
based on the latest internal estimate of the probability of
technical and regulatory success for each asset in
development.
General Medicines
General Medicines are usually
prescribed in the primary care or community settings by general
healthcare practitioners. For GSK, this includes medicines for
inhaled respiratory, dermatology, antibiotics and other
diseases.
Specialty Medicines
Specialty Medicines are typically
prescription medicines used to treat complex or rare chronic
conditions. For GSK, this comprises medicines for infectious
diseases, HIV, Respiratory/Immunology and Other and
Oncology.
Percentage points
Percentage points of growth which
is abbreviated to ppts.
Brand names and partner
acknowledgements: brand names appearing in italics throughout this
document are trademarks of GSK or associated companies or used
under licence by the Group.
Guidance and outlooks, assumptions
and cautionary statements
2024 Guidance
GSK expects 2024 sales to increase
between 5 to 7 per cent but now towards the upper part of the range
and Core Operating profit to increase between 9 to 11 percent
(previously 7 to 10 per cent). Core Earnings per share is expected
to increase between 8 to 10 percent (previously 6 to 9 per
cent).
The Group continues to expect high
single digit to low double-digit growth for Vaccines, low
double-digit growth for Specialty Medicines and a mid-single-digit
decrease for General Medicines.
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 Q1 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 months ended
31 March 2024.
The condensed financial
information comprises:
|
|
•
|
the income statement and statement
of comprehensive income for the three-month period ended 31 March
2024 on pages 23 and 24;
|
•
|
the balance sheet as at 31 March
2024 on page 25;
|
•
|
the statement of changes in equity
for the three-month period then ended on page 26;
|
•
|
the cash flow statement for the
three-month period then ended on page 27; and
|
•
|
the accounting policies and basis
of preparation and the explanatory notes to the condensed financial
information on pages 28 to 37 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.
|
We have read the other information
contained in the Results Announcement, including the non-IFRS
measures contained on pages 28 to 37 and considered whether it
contains any apparent misstatements or material inconsistencies
with the information in the condensed financial
information.
Based on our review, nothing has
come to our attention that causes us to believe that the condensed
financial information in the Results Announcement for the three
months ended 31 March 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
34.
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 34, 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 34.
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, our responsibility is to express to the Company a
conclusion on the condensed financial information in the Results
Announcement based on our review. Our Conclusion, including our
Conclusions Relating to Going Concern, are based on procedures that
are less extensive than audit procedures, as described in the Basis
of 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
1 May 2024