AstraZeneca
25 July 2024
H1 and Q2 2024 results
Strong underlying growth supports FY 2024
guidance upgrade, with both Total Revenue and Core EPS now expected
to increase by a mid teens percentage at CER[1]
Revenue and EPS
summary
|
|
H1 2024
|
% Change
|
Q2 2024
|
% Change
|
|
|
$m
|
Actual
|
CER
|
$m
|
Actual
|
CER
|
- Product Sales
|
|
24,629
|
15
|
18
|
12,452
|
14
|
18
|
- Alliance Revenue
|
|
939
|
50
|
50
|
482
|
42
|
42
|
- Collaboration Revenue
|
|
49
|
(78)
|
(78)
|
4
|
(98)
|
(98)
|
Total Revenue
|
|
25,617
|
15
|
18
|
12,938
|
13
|
17
|
Reported EPS
|
|
$2.65
|
13
|
23
|
$1.24
|
6
|
15
|
Core[2]
EPS
|
|
$4.03
|
(1)
|
5
|
$1.98
|
(8)
|
(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Financial performance for H1 2024
(Growth
numbers at constant exchange rates)
‒
Total Revenue up 18% to $25,617m, driven by an 18% increase
in Product Sales and continued growth in Alliance Revenue from
partnered medicines
‒
Total Revenue growth from Oncology was 22%, CVRM 22%, R&I
22%, and Rare Disease 15%
‒
Core Product Sales Gross
Margin[3] of
82%
‒
Core Operating Margin of 33%
‒
Core Tax Rate of 20%
‒
Core EPS increased 5% to $4.03. The increase in Core EPS was
lower than Total Revenue growth principally due to gains recognised
in the prior year, specifically a $241m gain on the disposal of
Pulmicort Flexhaler US
rights (Q1 2023), and a $712m gain relating to updates to
contractual arrangements for Beyfortus (Q2 2023)
‒
Interim dividend increased 7c to $1.00 (77.6 pence, 10.79
SEK) has been declared
‒
Guidance for FY 2024 increased, with Total Revenue and Core
EPS anticipated to grow by a mid teens percentage at CER
(previously a low double-digit to low teens percentage). An
increase in Collaboration Revenue is not assumed in the upgraded
guidance
Pascal Soriot, Chief Executive Officer, AstraZeneca,
said:
"Building on our strong growth in the first
half of the year and continued underlying demand for our medicines
we are upgrading our FY 2024 guidance for both Total Revenue and
Core EPS.
At our Investor Day in May we set out a new
revenue ambition to deliver $80 billion of Total Revenue by 2030.
This is a clear reflection of the substantial growth potential we
see from both our approved medicines and those in our late-stage
pipeline. Already this year we have announced five positive,
potentially practice-changing Phase III studies that are
anticipated to meaningfully contribute to our growth.
In the year to date we have continued to make
encouraging progress with several disruptive technologies,
including antibody drug conjugates, bispecifics, cell and gene
therapies, radioconjugates, and weight management medicines, all of
which have the potential to drive our growth beyond
2030."
Key milestones achieved since the prior results
announcement
‒
Positive read-outs for Imfinzi in combination with
chemotherapy in muscle-invasive bladder cancer (NIAGARA),
Calquence in untreated
mantle cell lymphoma (ECHO), Enhertu in HR-positive, HER2-low
metastatic breast cancer (DESTINY-Breast06)
‒
US approvals for Imfinzi in combination with
chemotherapy followed by Imfinzi monotherapy for primary
advanced or recurrent endometrial cancer that is mismatch repair
deficient (DUO-E). EU approvals for Truqap in combination with
Faslodex for
biomarker-positive estrogen receptor-positive,
HER2‑negative
advanced breast cancer (CAPItello-291), Tagrisso with the addition of
chemotherapy for 1st‑line EGFRm NSCLC (FLAURA2). Japan and China
approvals for Tagrisso
with the addition of chemotherapy for the 1st--‑line EGFRm NSCLC (FLAURA2)
Guidance
Due to strong underlying growth in Product
Sales and Alliance Revenue, the Company raises its Total Revenue
and Core EPS guidance for FY 2024 at CER, based on the average
foreign exchange rates through 2023.
Total Revenue is expected to
increase by a mid teens
percentage
(previously a low double-digit to low teens
percentage)
Core EPS is expected to increase by
a mid teens percentage
(previously a low double-digit to low teens percentage)
‒
An increase in Collaboration Revenue is not assumed in the
upgraded guidance (previously assumed a substantial
increase)
‒
Other operating income is expected to decrease substantially
(FY 2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights, and a
$712m one-time gain relating to updates to contractual arrangements
for Beyfortus)
‒
The Core Tax rate is expected to be between 18-22%
The Company is unable to provide guidance on a
Reported basis because it cannot reliably forecast material
elements of the Reported results, including any fair value
adjustments arising on acquisition-related liabilities, intangible
asset impairment charges and legal settlement provisions. Please
refer to the cautionary statements section regarding
forward-looking statements at the end of this
announcement.
Currency impact
If foreign exchange rates for July 2024 to
December 2024 were to remain at the average rates seen in June
2024, it is anticipated that FY 2024 Total Revenue would incur a
low single-digit percentage adverse impact compared to the
performance at CER, and Core EPS would incur a mid single-digit
percentage adverse impact. The Company's foreign exchange rate
sensitivity analysis is provided in Table 17.
Table 1: Key elements of Total Revenue
performance in Q2 2024
|
%
Change
|
|
|
|
Revenue type
|
|
$m
|
Actual
%
|
CER
%
|
|
|
Product Sales
|
|
12,452
|
14
|
18
|
|
|
Alliance Revenue
|
|
482
|
42
|
42
|
|
* $344m
Enhertu (Q2 2023:
$255m)
* $104m
Tezspire (Q2 2023:
$62m)
|
Collaboration Revenue
|
|
4
|
(98)
|
(98)
|
|
* Q2 2023
included $180m for COVID-19 mAbs
|
Total Revenue
|
|
12,938
|
13
|
17
|
|
|
Therapy areas
|
|
$m
|
Actual %
|
CER %
|
|
|
Oncology
|
|
5,331
|
15
|
19
|
|
* Tagrisso up 8% (12%
at CER) due to strong global demand, Calquence up 21% (22% at CER) with
sustained leadership in 1L CLL. Enhertu Total Revenue up 46% (49% at
CER)
|
CVRM
|
|
3,160
|
18
|
22
|
|
* Farxiga up 29% (32%
at CER), Lokelma up 36% (41% at CER)
|
R&I
|
|
1,905
|
23
|
26
|
|
* Breztri up 44% (47%
at CER). Saphnelo up 65%,
Tezspire up 97% (>2x at
CER), Symbicort up 20%
(25% CER)
|
V&I
|
|
119
|
(57)
|
(53)
|
|
* The drop
in V&I revenue was primarily driven by lower Collaboration
Revenue from COVID-19 mAbs
* Beyfortus revenue
was $35m (Q2 2023: $2m), which more than offset a $6m decline in
Synagis
|
Rare Disease
|
|
2,147
|
10
|
14
|
|
* Ultomiris up 33%
(36% at CER), partially offset by decline in Soliris of 14% (8% at CER)
* Strensiq up 13%
(14% at CER) and Koselugo
up 43% (45% at CER)
|
Other Medicines
|
|
276
|
(11)
|
(5)
|
|
|
Total Revenue
|
|
12,938
|
13
|
17
|
|
|
Regions
|
|
$m
|
Actual %
|
CER %
|
|
|
US
|
|
5,571
|
17
|
17
|
|
|
Emerging Markets
|
|
3,386
|
9
|
18
|
|
|
-
China
|
|
1,630
|
13
|
18
|
|
|
- Ex-China
Emerging Markets
|
|
1,756
|
5
|
18
|
|
|
Europe
|
|
2,732
|
24
|
24
|
|
|
Established RoW
|
|
1,249
|
(5)
|
6
|
|
|
Total Revenue
|
|
12,938
|
13
|
17
|
|
|
|
|
|
|
|
|
|
|
|
| |
Key partnered medicines
‒
Combined sales of Enhertu, recorded by Daiichi Sankyo
Company Limited (Daiichi Sankyo) and AstraZeneca, amounted $1,772m
in H1 2024 (H1 2023: $1,169m).
‒
Combined sales of Tezspire, recorded by Amgen and
AstraZeneca, amounted to $507m in H1 2024 (H1 2023:
$257m).
‒
Table 2: Key elements of financial
performance in Q2 2024
Metric
|
Reported
|
Reported
change
|
Core
|
Core
change
|
|
Comments[4]
|
Total Revenue
|
$12,938m
|
13%
Actual 17% CER
|
$12,938m
|
13%
Actual 17% CER
|
|
* See Table 1 and the Total Revenue section of this document
for further details
|
Product Sales Gross Margin
|
82%
|
Stable
Actual
Stable CER
|
83%
|
Stable
Actual
Stable CER
|
|
* Variations in Product Sales Gross Margin can be expected
between periods due to product seasonality (e.g. FluMist and Beyfortus in H2), foreign exchange
fluctuations and other effects
|
R&D
expense
|
$3,008m
|
13%
Actual 13% CER
|
$2,872m
|
12%
Actual 13% CER
|
|
+ Increased investment in the
pipeline
* Core R&D-to-Total Revenue ratio of 22%
(Q2 2023: 22%)
|
SG&A expense
|
$4,929m
|
-1%
Actual 1% CER
|
$3,735m
|
13%
Actual 16% CER
|
|
+ Market development for recent launches and
pre-launch activities
* Core SG&A-to-Total Revenue ratio of 29%
(Q2 2023: 29%)
|
Other operating income and expense[5]
|
$60m
|
-92%
Actual -92% CER
|
$60m
|
-92%
Actual -92% CER
|
|
‒ The prior year
quarter included a $712m gain relating to updates to contractual
arrangements for Beyfortus
|
Operating Margin
|
21%
|
Stable
Actual +1pp CER
|
32%
|
-6pp
Actual -5pp CER
|
|
* See commentary above on Gross Margin, R&D, SG&A and
Other operating income and expense
|
Net finance expense
|
$343m
|
-7%
Actual -7% CER
|
$285m
|
10%
Actual 10% CER
|
|
+ Higher level of Net debt
|
Tax rate
|
20%
|
+7pp
Actual +7pp CER
|
19%
|
+2pp
Actual +2pp CER
|
|
*
Variations in the tax rate can be expected between
periods
|
EPS
|
$1.24
|
6%
Actual 15% CER
|
$1.98
|
-8%
Actual -3% CER
|
|
* Further details of differences between Reported and Core are
shown in Table 12
|
Table 3: Pipeline highlights since prior
results announcement
Event
|
Medicine
|
Indication /
Trial
|
Event
|
Regulatory approvals and other regulatory
actions
|
Imfinzi
|
Primary advanced or recurrent
endometrial cancer with mismatch repair deficiency
(DUO-E)
|
Regulatory approval (US), CHMP positive opinion
(EU)
|
Imfinzi +
Lynparza
|
Primary advanced or recurrent
endometrial cancer with mismatch repair proficiency
(DUO-E)
|
CHMP positive opinion (EU)
|
Tagrisso
|
EGFRm NSCLC
(1st-line)
(FLAURA2)
|
Regulatory approval (EU, JP, CN)
|
Truqap
|
Biomarker-positive ER-positive
HER2-negative locally advanced or metastatic breast cancer
(CAPItello-291)
|
Regulatory approval (EU)
|
|
|
|
Regulatory submissions
or acceptances*
|
Tagrisso
|
EGFRm NSCLC
(Stage III unresectable) (LAURA)
|
sNDA acceptance and Priority Review
(US)
|
Dato-DXd
|
Non-squamous NSCLC (2nd- and
3rd-line) (TROPION-Lung01)
|
Regulatory submission (EU)
|
sipavibart
|
Prevention of COVID-19
(SUPERNOVA)
|
Regulatory submission (EU)
|
|
|
|
Major Phase III data readouts and other
developments
|
Calquence
|
Mantle cell lymphoma (1st‑line)
(ECHO)
|
Primary endpoint met
|
Dato-DXd
|
Locally advanced or metastatic NSCLC
(TROPION-Lung01)
|
Dual primary endpoint OS not met in
the intention to treat population
|
Enhertu
|
HER2-low breast cancer (2nd-line)
(DESTINY-Breast-06)
|
Primary endpoint met
|
Imfinzi
|
Muscle-invasive bladder cancer
(NIAGARA)
|
Primary endpoint met
|
Imfinzi
|
Adjuvant use in early-stage PD-L1
≥25% NSCLC (Adjuvant BR.31)
|
Primary endpoint not met
|
|
|
|
|
|
Truqap
|
Locally advanced or metastatic TNBC
(CAPItello-290)
|
Primary endpoint not met
|
|
|
|
|
|
sipavibart
|
Prevention of COVID-19 (SUPERNOVA)
|
Primary
endpoint met
|
*US, EU and China regulatory submission denotes filing
acceptance
Upcoming pipeline catalysts
For recent trial starts and anticipated timings
of key trial readouts, please refer to the Clinical Trials
Appendix, available on www.astrazeneca.com/investor-relations.html.
Corporate and business development
In May 2024, AstraZeneca announced its
intention to build a $1.5 billion manufacturing facility in
Singapore for antibody drug conjugates (ADCs), enhancing global
supply of its ADC portfolio. ADCs are next-generation treatments
that deliver highly potent cancer-killing agents directly to cancer
cells through a targeted antibody. The planned greenfield facility,
supported by the Singapore Economic Development Board, will be
AstraZeneca's first end-to-end ADC production site, fully
incorporating all steps of the manufacturing process at a
commercial scale. Manufacturing of ADCs is a multi-step process
that comprises antibody production, synthesis of chemotherapy drug
and linker, conjugation of drug-linker to the antibody, and filling
of the completed ADC substance.
In May 2024, AstraZeneca completed an
additional $140m equity investment in Cellectis, a clinical-stage
biotechnology company. The equity investment and a research
collaboration agreement, announced in November 2023, will leverage
the Cellectis proprietary gene editing technologies and
manufacturing capabilities, to design up to 10 novel cell and gene
therapy products for areas of high unmet need, including oncology,
immunology and rare diseases. In Q4 2023, Cellectis received an
initial payment of $105m from AstraZeneca, which comprised a $25m
upfront cash payment under the terms of a research collaboration
agreement and an $80m equity investment. Now that the additional
$140m equity investment has closed, AstraZeneca holds a total
equity stake of c.44% in Cellectis and AstraZeneca continues to
treat its investment in Cellectis as an associate.
In June 2024, AstraZeneca completed the
acquisition of Fusion Pharmaceuticals Inc., a clinical-stage
biopharmaceutical company developing next-generation
radioconjugates. The acquisition marks a major step forward in
AstraZeneca delivering on its ambition to transform cancer
treatment and outcomes for patients by replacing traditional
regimens like chemotherapy and radiotherapy with more targeted
treatments. The acquisition complements AstraZeneca's leading
oncology portfolio with the addition of the Fusion pipeline of
radioconjugates, including FPI-2265, a potential new treatment for
patients with mCRPC, and brings new expertise and pioneering
R&D, manufacturing and supply chain capabilities in
actinium-based radioconjugates to AstraZeneca. See Note 5 for
further information.
In July 2024, AstraZeneca completed
the acquisition of
Amolyt Pharma, a clinical-stage biotechnology company focused on
developing novel treatments for rare endocrine diseases. The
acquisition bolsters the Alexion, AstraZeneca Rare Disease
late-stage pipeline and expands on its bone metabolism franchise
with the notable addition of eneboparatide (AZP-3601), a Phase III
investigational therapeutic peptide with a novel mechanism of
action designed to meet key therapeutic goals for
hypoparathyroidism. In patients with hypoparathyroidism, a
deficiency in parathyroid hormone production results in significant
dysregulation of calcium and phosphate, which can lead to
life-altering symptoms and complications, including chronic kidney
disease. See Note 7 for further information.
Sustainability highlights
At the 77th World Health Assembly in Geneva,
Switzerland in May, AstraZeneca convened Ministers of Health,
industry, civil society and patient groups. Areas of focus for
engagement, led by Ruud Dobber, EVP BioPharmaceuticals, included
the need to increase early action to prevent, diagnose and treat
disease and to accelerate collaboration to build resilient,
equitable and net zero health systems.
Conference call
A conference call and webcast for investors and
analysts will begin today, 25 July 2024, at 11:45 UK time. Details
can be accessed via astrazeneca.com.
Reporting calendar
The Company intends to publish its 9M and Q3
2024 results on 12 November 2024.
Conclusion of
audit tender
Following a rigorous process, the audit tender
for the Group's external audit provider has now concluded. The
Audit Committee has recommended, and the Board has endorsed, the
appointment of KPMG as the Group's external auditor for the
financial year ending 31 December 2026. A resolution will be put to
shareholders at the 2026 Annual General Meeting (AGM) to approve
this appointment. It is intended that PwC, who have been the
Group's auditor since the year ended 31 December 2017, will
continue as the Group's auditors for the years ended 31 December
2024 and 2025 and will cease to hold office at the conclusion of
the Company's 2026 AGM.
Operating and financial review
All narrative on growth and results in this
section is based on actual exchange rates, and financial figures
are in US$ millions ($m), unless stated otherwise. Unless stated
otherwise, the performance shown in this announcement covers the
six month period to 30 June 2024 ('the half year' or 'H1 2024')
compared to the six month period to 30 June 2023 ('H1
2023').
Core financial measures, EBITDA, Net debt,
Product Sales Gross Margin, Operating Margin and CER are non-GAAP
financial measures because they cannot be derived directly from the
Group's Condensed consolidated financial statements. Management
believes that these non-GAAP financial measures, when provided in
combination with Reported results, provide investors and analysts
with helpful supplementary information to understand better the
financial performance and position of the Group on a comparable
basis from period to period. These non-GAAP financial measures are
not a substitute for, or superior to, financial measures prepared
in accordance with GAAP.
Core financial measures are adjusted to exclude
certain significant items:
‒
Charges and provisions related to restructuring programmes,
which includes charges that relate to the impact of restructuring
programmes on capitalised IT assets
‒
Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT
assets
‒
Other specified items, principally the imputed finance
charges and fair value movements relating to contingent
consideration on business combinations, imputed finance charges and
remeasurement adjustments on certain Other payables arising from
intangible asset acquisitions, legal settlements and remeasurement
adjustments relating to Other payables assumed from the Alexion
acquisition
‒
The tax effects of the adjustments above are excluded from
the Core Tax charge
Details on the nature of Core financial
measures are provided on page 61 of the
Annual Report and Form 20-F Information 2023.
Reference should be made to the Reconciliation
of Reported to Core financial measures table included in the
financial performance section in this announcement.
Product Sales Gross Margin is
calculated by dividing the difference between Product Sales and
Cost of Sales by the Product Sales. The calculation of
Reported and Core Product Sales Gross Margin excludes the impact of
Alliance Revenue and Collaboration Revenue and any associated
costs, thereby reflecting the underlying performance of Product
Sales.
EBITDA is defined as Reported Profit before tax
after adding back Net finance expense, results from Joint ventures
and associates and charges for Depreciation, amortisation and
impairment. Reference should be made to the Reconciliation of
Reported Profit before tax to EBITDA included in the financial
performance section in this announcement.
Operating margin is defined as Operating profit
as a percentage of Total Revenue.
Net debt is defined as Interest-bearing loans
and borrowings and Lease liabilities, net of Cash and cash
equivalents, Other investments, and Net derivative financial
instruments. Reference should be made to Note 3 'Net debt' included
in the Notes to the Interim financial statements in this
announcement.
The Company strongly encourages investors and
analysts not to rely on any single financial measure, but to review
AstraZeneca's financial statements, including the Notes thereto,
and other available Company reports, carefully and in their
entirety.
Due to rounding, the sum of a number of dollar
values and percentages in this announcement may not agree to
totals.
Table 4: Total Revenue by therapy area and
medicine[6]
Total
Revenue
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Oncology
|
|
10,440
|
41
|
19
|
22
|
5,331
|
41
|
15
|
19
|
-
Tagrisso
|
|
3,203
|
13
|
10
|
13
|
1,608
|
12
|
8
|
12
|
-
Imfinzi
|
|
2,259
|
9
|
20
|
25
|
1,147
|
9
|
13
|
18
|
-
Calquence
|
|
1,508
|
6
|
27
|
28
|
790
|
6
|
21
|
22
|
-
Lynparza
|
|
1,450
|
6
|
6
|
9
|
744
|
6
|
4
|
7
|
-
Enhertu
|
|
932
|
4
|
61
|
62
|
472
|
4
|
46
|
49
|
-
Zoladex
|
|
567
|
2
|
19
|
26
|
282
|
2
|
17
|
25
|
-
Imjudo
|
|
136
|
1
|
35
|
38
|
74
|
1
|
17
|
19
|
-
Truqap
|
|
142
|
1
|
n/m
|
n/m
|
92
|
1
|
n/m
|
n/m
|
-
Orpathys
|
|
25
|
-
|
14
|
18
|
13
|
-
|
(5)
|
(1)
|
- Other Oncology
|
|
216
|
1
|
(21)
|
(15)
|
109
|
1
|
(17)
|
(11)
|
BioPharmaceuticals: CVRM
|
|
6,220
|
24
|
19
|
22
|
3,160
|
24
|
18
|
22
|
-
Farxiga
|
|
3,836
|
15
|
35
|
38
|
1,945
|
15
|
29
|
32
|
-
Brilinta
|
|
665
|
3
|
-
|
2
|
342
|
3
|
3
|
5
|
-
Crestor
|
|
590
|
2
|
1
|
6
|
293
|
2
|
4
|
11
|
-
Lokelma
|
|
249
|
1
|
26
|
30
|
136
|
1
|
36
|
41
|
-
Seloken/Toprol-XL
|
|
315
|
1
|
(8)
|
(1)
|
150
|
1
|
(8)
|
-
|
-
roxadustat
|
|
167
|
1
|
22
|
27
|
90
|
1
|
20
|
25
|
-
Andexxa
|
|
105
|
-
|
18
|
21
|
59
|
-
|
29
|
35
|
-
Wainua
|
|
21
|
-
|
n/m
|
n/m
|
16
|
-
|
n/m
|
n/m
|
- Other CVRM
|
|
272
|
1
|
(30)
|
(28)
|
130
|
1
|
(26)
|
(24)
|
BioPharmaceuticals: R&I
|
|
3,791
|
15
|
19
|
22
|
1,905
|
15
|
23
|
26
|
-
Symbicort
|
|
1,491
|
6
|
16
|
19
|
722
|
6
|
20
|
25
|
-
Fasenra
|
|
781
|
3
|
5
|
6
|
423
|
3
|
4
|
5
|
-
Breztri
|
|
454
|
2
|
48
|
51
|
235
|
2
|
44
|
47
|
-
Pulmicort
|
|
379
|
1
|
10
|
14
|
155
|
1
|
25
|
30
|
-
Tezspire
|
|
280
|
1
|
>2x
|
>2x
|
160
|
1
|
97
|
>2x
|
-
Saphnelo
|
|
203
|
1
|
77
|
77
|
112
|
1
|
65
|
65
|
-
Airsupra
|
|
21
|
-
|
n/m
|
n/m
|
14
|
-
|
n/m
|
n/m
|
- Other
R&I
|
|
181
|
1
|
(26)
|
(25)
|
83
|
1
|
(21)
|
(19)
|
BioPharmaceuticals: V&I
|
|
350
|
1
|
(45)
|
(42)
|
119
|
1
|
(57)
|
(53)
|
-
Beyfortus
|
|
80
|
-
|
>10x
|
>10x
|
35
|
-
|
>10x
|
>10x
|
-
Synagis
|
|
253
|
1
|
(11)
|
(6)
|
81
|
1
|
(6)
|
8
|
- COVID-19
mAbs
|
|
3
|
-
|
(99)
|
(99)
|
1
|
-
|
(99)
|
(99)
|
-
FluMist
|
|
8
|
-
|
(34)
|
(36)
|
2
|
-
|
(84)
|
(84)
|
- Other V&I
|
|
6
|
-
|
(79)
|
(80)
|
-
|
-
|
n/m
|
n/m
|
Rare Disease
|
|
4,243
|
17
|
11
|
15
|
2,147
|
17
|
10
|
14
|
-
Ultomiris
|
|
1,804
|
7
|
32
|
35
|
946
|
7
|
33
|
36
|
-
Soliris
|
|
1,439
|
6
|
(13)
|
(8)
|
700
|
5
|
(14)
|
(8)
|
-
Strensiq
|
|
653
|
3
|
16
|
18
|
340
|
3
|
13
|
14
|
-
Koselugo
|
|
247
|
1
|
55
|
64
|
114
|
1
|
43
|
45
|
-
Kanuma
|
|
100
|
-
|
17
|
20
|
47
|
-
|
3
|
8
|
Other Medicines
|
|
573
|
2
|
(9)
|
(2)
|
276
|
2
|
(11)
|
(5)
|
- Nexium
|
|
469
|
2
|
(6)
|
2
|
227
|
2
|
(10)
|
(3)
|
- Others
|
|
104
|
-
|
(21)
|
(18)
|
49
|
-
|
(16)
|
(12)
|
Total
|
|
25,617
|
100
|
15
|
18
|
12,938
|
100
|
13
|
17
|
Table 5: Alliance
Revenue
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Enhertu
|
|
683
|
73
|
44
|
44
|
344
|
71
|
35
|
36
|
Tezspire
|
|
180
|
19
|
72
|
72
|
104
|
22
|
67
|
67
|
Beyfortus
|
|
26
|
3
|
n/m
|
n/m
|
7
|
1
|
n/m
|
n/m
|
Other Alliance Revenue
|
|
50
|
5
|
4
|
4
|
27
|
6
|
17
|
17
|
Total
|
|
939
|
100
|
50
|
50
|
482
|
100
|
42
|
42
|
Table 6: Collaboration
Revenue
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Farxiga: sales
milestones
|
|
49
|
100
|
96
|
96
|
4
|
100
|
>5x
|
>5x
|
COVID-19 mAbs: licence fees
|
|
-
|
-
|
n/m
|
n/m
|
-
|
-
|
n/m
|
n/m
|
Other Collaboration Revenue
|
|
-
|
-
|
(98)
|
(98)
|
-
|
-
|
n/m
|
n/m
|
Total
|
|
49
|
100
|
(78)
|
(78)
|
4
|
100
|
(98)
|
(98)
|
Table 7: Total Revenue by therapy
area
|
|
$m
|
%
Total
|
Actual
|
CER
|
$m
|
%
Total
|
Actual
|
CER
|
Oncology
|
|
10,440
|
41
|
19
|
22
|
5,331
|
41
|
15
|
19
|
Biopharmaceuticals
|
|
10,362
|
40
|
14
|
17
|
5,184
|
40
|
15
|
19
|
CVRM
|
|
6,220
|
24
|
19
|
22
|
3,160
|
24
|
18
|
22
|
R&I
|
|
3,791
|
15
|
19
|
22
|
1,905
|
15
|
23
|
26
|
V&I
|
|
350
|
1
|
(45)
|
(42)
|
119
|
1
|
(57)
|
(53)
|
Rare Disease
|
|
4,243
|
17
|
11
|
15
|
2,147
|
17
|
10
|
14
|
Other Medicines
|
|
573
|
2
|
(9)
|
(2)
|
276
|
2
|
(11)
|
(5)
|
Total
|
|
25,617
|
100
|
15
|
18
|
12,938
|
100
|
13
|
17
|
Table 8: Total Revenue by
region
|
|
$m
|
%
Total
|
Actual
|
CER
|
$m
|
%
Total
|
Actual
|
CER
|
US
|
|
10,695
|
42
|
18
|
18
|
5,571
|
43
|
17
|
17
|
Emerging Markets
|
|
7,119
|
28
|
13
|
22
|
3,386
|
26
|
9
|
18
|
China
|
|
3,378
|
13
|
11
|
15
|
1,630
|
13
|
13
|
18
|
Emerging
Markets ex. China
|
|
3,740
|
15
|
16
|
29
|
1,756
|
14
|
5
|
18
|
Europe
|
|
5,365
|
21
|
23
|
22
|
2,732
|
21
|
24
|
24
|
Established ROW
|
|
2,438
|
10
|
(5)
|
4
|
1,249
|
10
|
(5)
|
6
|
Total
|
|
25,617
|
100
|
15
|
18
|
12,938
|
100
|
13
|
17
|
Oncology
Oncology Total Revenue of $10,440m in H1 2024
increased by 19% (22% at CER), representing 41% of overall Total
Revenue (H1 2023: 39%).
Tagrisso
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
3,203
|
|
1,282
|
919
|
628
|
374
|
Actual change
|
|
10%
|
|
16%
|
8%
|
16%
|
(11%)
|
CER change
|
|
13%
|
|
16%
|
16%
|
15%
|
(2%)
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Strong global demand for Tagrisso in adjuvant (ADAURA) and
1st-line settings (FLAURA, FLAURA2)
|
US
|
|
* Continued adjuvant and 1st-line demand growth
|
Emerging Markets
|
|
* Encouraging demand growth across markets despite local
competition in China
|
Europe
|
|
* Continued demand growth in 1st-line and adjuvant
settings
|
Established RoW
|
|
* Continued growth across indications, impacted by 10.5%
mandatory price reduction in Japan effective from June
2023
|
Imfinzi
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
2,259
|
|
1,202
|
245
|
459
|
353
|
Actual change
|
|
20%
|
|
17%
|
35%
|
38%
|
7%
|
CER change
|
|
25%
|
|
17%
|
58%
|
36%
|
19%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Continued growth driven by BTC (TOPAZ-1), HCC (HIMALAYA), and
increased patient share in Stage IV NSCLC (POSEIDON) and
extensive-stage SCLC (CASPIAN)
|
US
|
|
* Continued demand growth driven primarily by HCC and
extensive-stage SCLC, having achieved peak market share and
stabilisation in BTC
|
Emerging Markets
|
|
* New patient share growth across all indications
* China growth driven largely by increasing demand in
BTC
|
Europe
|
|
* Growth driven by share gains in extensive-stage SCLC and new
launches in HCC, BTC and NSCLC
|
Established RoW
|
|
* Increased demand in GI indications, offset by a 25% mandatory price reduction in Japan effective
from 1 February 2024
|
Calquence
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
1,508
|
|
1,048
|
75
|
320
|
65
|
Actual change
|
|
27%
|
|
21%
|
82%
|
42%
|
30%
|
CER change
|
|
28%
|
|
21%
|
>2x
|
41%
|
34%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Sustained leadership in front-line CLL (ELEVATE-TN) and
increased global penetration
|
US
|
|
* Growth driven by leading share of new patient starts in
front-line CLL, and improved affordability
|
Europe
|
|
* Continued strong growth in front-line
|
Lynparza
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
1,450
|
|
607
|
320
|
398
|
125
|
Actual change
|
|
6%
|
|
5%
|
15%
|
9%
|
(14%)
|
CER change
|
|
9%
|
|
5%
|
26%
|
8%
|
(6%)
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Lynparza
remains the leading medicine in the PARP
inhibitor class globally across four tumour types (ovarian, breast,
prostate, pancreatic), as measured by total prescription
volume
* No Collaboration Revenue for Lynparza was recognised in either H1
2024 or H1 2023, hence the Product Sales numbers are identical to
the Total Revenue numbers shown above
|
US
|
|
* Continued leadership within PARP inhibitor class despite
competition, offset by negative class pressure and
maturity
|
Emerging Markets
|
|
* Volume growth in China from increased share in newly
diagnosed BRCA-mutated ovarian cancer (SOLO-1) and inclusion of
HRD-positive ovarian cancer (PAOLA-1) on NRDL with no price
reduction
|
Europe
|
|
* Demand growth driven by recent launches in mCRPC (PROpel) and
early breast cancer (OlympiA)
|
Established RoW
|
|
* Demand growth from 1st-line ovarian cancer, offset by price
reduction in Japan effective from November 2023
|
Enhertu
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
932
|
|
414
|
224
|
263
|
31
|
Actual change
|
|
61%
|
|
22%
|
>2x
|
>2x
|
>3x
|
CER change
|
|
62%
|
|
22%
|
>2x
|
>2x
|
>3x
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Combined sales of Enhertu, recorded by Daiichi Sankyo
and AstraZeneca, amounted to $1,772m in H1 2024 (H1 2023:
$1,169m)
|
US
|
|
* US in-market sales, recorded by Daiichi Sankyo, amounted to
$865m in H1 2024 (H1 2023: $712m)
* Continued demand across all indications with encouraging
early launch following tumour-agnostic approval in April 2024
(DESTINY-PanTumor02, DESTINY-Lung01, DESTINY‑CRC02)
|
Emerging Markets
|
|
* Sustained demand growth, with quarterly phasing impacted by
launch-related inventory build in China in Q1 2024 and subsequent
destocking
|
Europe
|
|
* Continued demand growth due to increasing adoption in
HER2-positive (DESTINY-Breast03) and HER2-low (DESTINY-Breast04)
metastatic breast cancer
|
Established RoW
|
|
* AstraZeneca's Alliance Revenue includes a mid single-digit
percentage royalty on Daiichi Sankyo's sales in Japan
|
Other Oncology medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Zoladex
|
|
567
|
19%
|
26%
|
* Strong underlying growth in China and Emerging Markets and
moderate growth in Europe offset by drop in Japan
|
Imjudo
|
|
136
|
35%
|
38%
|
* Continued growth across markets slightly offset by US
inventory destocking in H1 2024
|
Truqap
|
|
142
|
n/m
|
n/m
|
* Strong demand growth with strong uptake in biomarker altered
subgroup of HR-positive HER2-negative metastatic breast cancer
(CAPItello-291)
|
Orpathys
|
|
25
|
14%
|
18%
|
* Demand in China for the treatment of patients with NSCLC with
MET exon 14 skipping alterations
|
Other Oncology
|
|
216
|
(21%)
|
(15%)
|
* Decline in Faslodex
Total Revenue due to VBP implementation in China in March 2024 in
addition to ongoing generic erosion in Europe
|
BioPharmaceuticals
BioPharmaceuticals Total Revenue increased by
14% (17% at CER) in H1 2024 to $10,362m, representing 40% of
overall Total Revenue (H1 2023: 41%).
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 19% (22% at
CER) to $6,220m in H1 2024 and represented 24% of overall Total
Revenue (H1 2023: 24%).
Farxiga
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
3,836
|
|
869
|
1,474
|
1,233
|
260
|
Actual change
|
|
35%
|
|
37%
|
37%
|
45%
|
(5%)
|
CER change
|
|
38%
|
|
37%
|
44%
|
44%
|
3%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Farxiga
volume is growing faster than the overall SGLT2
market in all major regions, driven by continued demand in heart
failure and CKD
* SGLT2 class growth underpinned by updated cardiorenal
guidelines
|
US
|
|
* Growth driven by underlying demand in HFrEF and
CKD
* Launch of an authorised generic in the first quarter of
2024
|
Emerging Markets
|
|
* Increased reimbursement supporting solid growth despite entry
of generic competition in some markets
* Strong momentum in Latin America
|
Europe
|
|
*
Continued strong class growth and market share gains fuelled
by HFpEF approval in 2023 and guidelines updates
|
Established RoW
|
|
* Performance impacted by generic competition in
Canada
* In Japan, AstraZeneca sells to collaborator Ono
Pharmaceutical Co., Ltd, which records in-market sales
|
Other CVRM medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Brilinta
|
|
665
|
-
|
2%
|
* Continued sales growth in Emerging Markets, decline in Est.
RoW driven by generic competition in Canada
|
Crestor
|
|
590
|
1%
|
6%
|
* Continued sales growth in Emerging Markets
|
Seloken
|
|
315
|
(8%)
|
(1%)
|
* Stable following VBP implementation in China in
2022
|
Lokelma
|
|
249
|
26%
|
30%
|
* Strong growth in all major regions. Continued launches in new
markets
|
roxadustat
|
|
167
|
22%
|
27%
|
*
Increased demand in both the dialysis and
non-dialysis-dependent populations. NRDL listing renewed
|
Andexxa
|
|
105
|
18%
|
21%
|
* Growth in all major regions
|
Wainua
|
|
21
|
n/m
|
n/m
|
* Encouraging launch uptake following ATTRv-PN approval in the
US in December 2023
|
Other CVRM
|
|
272
|
(30%)
|
(28%)
|
|
BioPharmaceuticals - R&I
Total Revenue of $3,791m from R&I medicines
increased 19% (22% at CER) and represented 15% of overall Total
Revenue (H1 2023: 14%). This reflected growth in Fasenra, Tezspire, Breztri, Saphnelo and Airsupra, following its recent
launch.
Fasenra
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
781
|
|
478
|
41
|
192
|
70
|
Actual change
|
|
5%
|
|
2%
|
45%
|
9%
|
(2%)
|
CER change
|
|
6%
|
|
2%
|
53%
|
8%
|
6%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Continued asthma market share leadership in IL-5 class across
major markets
|
US
|
|
* Maintained share of a growing severe asthma biologics
market
|
Emerging Markets
|
|
* Continued strong demand growth driven by launch acceleration across key markets
|
Europe
|
|
* Expanded leadership in severe eosinophilic
asthma
|
Established RoW
|
|
* In
Japan, maintained class leadership in a broadly stable
market
|
Breztri
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
454
|
|
225
|
131
|
65
|
33
|
Actual change
|
|
48%
|
|
37%
|
61%
|
80%
|
33%
|
CER change
|
|
51%
|
|
37%
|
69%
|
79%
|
44%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Fastest growing medicine within the expanding
FDC triple class, across major markets
|
US
|
|
* Consistent share growth within the expanding FDC triple
class
|
Emerging Markets
|
|
* Maintained market share leadership in China with strong
triple FDC class penetration
* Further expansion with launches in additional
geographies
|
Europe
|
|
* Sustained growth across markets driven by new
launches
|
Established RoW
|
|
* Increased market share in Japan
|
Tezspire
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
280
|
|
180
|
5
|
61
|
34
|
Actual change
|
|
>2x
|
|
72%
|
>10x
|
>3x
|
>2x
|
CER change
|
|
>2x
|
|
72%
|
>10x
|
>3x
|
>2x
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Combined sales of Tezspire, recorded by Amgen and
AstraZeneca, amounted to $507m in H1 2024 (H1 2023:
$257m)
|
US
|
|
* Continued growth in total prescriptions, and maintained
new-to-brand market share with majority of patients
new-to-biologics
|
Europe
|
|
* Achieved new-to-brand leadership across multiple markets, new
launches continue to progress
|
Established RoW
|
|
* Japan maintained new-to-brand leadership
|
Symbicort
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
1,491
|
|
598
|
450
|
286
|
157
|
Actual change
|
|
16%
|
|
38%
|
11%
|
-
|
(4%)
|
CER change
|
|
19%
|
|
38%
|
21%
|
(1%)
|
(2%)
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Symbicort remained
the global market leader within a stable ICS/LABA class
|
US
|
|
* Continued strong demand for the authorised generic and
favourable channel mix
|
Emerging Markets
|
|
* Strong
demand growth
|
Europe
|
|
*
Continued price and volume erosion from generics and a
slowing overall market partially offset by growth in some markets
within mild asthma
|
Established RoW
|
|
*
Continued generic erosion in Japan
|
Other R&I medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Pulmicort
|
|
379
|
10%
|
14%
|
* >80%
of revenues from Emerging Markets
|
Saphnelo
|
|
203
|
77%
|
77%
|
*
Demand acceleration in the US, and
additional growth driven by ongoing launches in Europe and
Established RoW
|
Airsupra
|
|
21
|
n/m
|
n/m
|
* Strong
US launch momentum and volume uptake. Revenue in the period
reflects introductory discounts as early access continues to
build
|
Other R&I
|
|
181
|
(26%)
|
(25%)
|
* Generic
competition
|
BioPharmaceuticals - V&I
Total Revenue from V&I medicines reduced by
45% (42% at CER) to $350m (H1 2023: $632m) and represented 1% of
overall Total Revenue (H1 2023: 3%). Collaboration Revenue was $nil
in the period (H1 2023: $190m).
V&I medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Beyfortus
|
|
80
|
>10x
|
>10x
|
* Product Sales recognises AstraZeneca's sales of manufactured
Beyfortus product to
Sanofi
* Alliance Revenue recognises AstraZeneca's 50% share of gross
profits on sales of Beyfortus in major markets outside the
US, and 25% of brand revenues in rest of world markets
* AstraZeneca has no participation in US profits or
losses
|
Synagis
|
|
253
|
(11%)
|
(6%)
|
* Decline has been more than offset by Beyfortus growth
|
COVID-19 mAbs
|
|
3
|
(99%)
|
(99%)
|
* Decline
in Evusheld sales and
Collaboration Revenue (Total Revenue H1 2023: $306m)
|
FluMist
|
|
8
|
(34%)
|
(36%)
|
|
Other V&I
|
|
6
|
(79%)
|
(80%)
|
* Decline in Vaxzevria
sales (H1 2023: $28m)
|
Rare Disease
Total Revenue from Rare Disease
medicines increased by 11% (15% at CER) in H1 2024 to $4,243m,
representing 17% of overall Total Revenue (H1 2023:
17%).
Ultomiris
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
1,804
|
|
1,032
|
66
|
411
|
295
|
Actual change
|
|
32%
|
|
27%
|
>2x
|
32%
|
42%
|
CER change
|
|
35%
|
|
27%
|
>2x
|
31%
|
58%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Growth due to increased use in neurology, geographic
expansion, further patient demand and conversion from Soliris
* The reported revenues for Ultomiris include sales of
Voydeya, which is approved
as an add‑on treatment to Ultomiris and Soliris for the 10-20% of PNH patients
who experience clinically significant EVH.
* Voydeya
is a strategic launch in this small subset of PNH
patients. Voydeya ensures
these patients can remain on the standard of care, Ultomiris
|
US
|
|
* Patient growth in gMG and newly launched NMOSD, continued
conversion from Soliris
|
Emerging Markets
|
|
* Continued growth following launches in new markets
|
Europe
|
|
* Strong demand growth following recent launches, particularly
from neurology indications, accelerated conversion from
Soliris in key markets,
partially offset by price reductions to secure reimbursement for
new indications
|
Established RoW
|
|
* Continued conversion from Soliris and strong demand following
new launches
|
Soliris
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
1,439
|
|
808
|
255
|
260
|
116
|
Actual change
|
|
(13%)
|
|
(9%)
|
19%
|
(29%)
|
(33%)
|
CER change
|
|
(8%)
|
|
(9%)
|
54%
|
(30%)
|
(30%)
|
Region
|
|
Drivers and commentary
|
US
|
|
* Decline driven by successful conversion of Soliris patients to Ultomiris
|
Emerging Markets
|
|
* Growth driven by patient demand following launches in new
markets
|
Europe
|
|
* Decline driven by biosimilar erosion in PNH and aHUS and
successful conversion from Soliris to Ultomiris
|
Established RoW
|
|
* Decline driven by successful conversion from Soliris to Ultomiris
|
Strensiq
H1 2024, $m
|
|
Worldwide
|
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
Total Revenue
|
|
653
|
|
529
|
31
|
48
|
45
|
Actual change
|
|
16%
|
|
17%
|
30%
|
14%
|
4%
|
CER change
|
|
18%
|
|
17%
|
47%
|
12%
|
15%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
* Growth driven by strong patient demand
|
Other Rare Disease medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Koselugo
|
|
247
|
55%
|
64%
|
* Driven by patient demand and expansion in new
markets
|
Kanuma
|
|
100
|
17%
|
20%
|
* Continued global demand
|
Other medicines (outside the main therapy
areas)
Total Revenue
|
|
$m
|
Actual
|
CER
|
Drivers and commentary
|
Nexium
|
|
469
|
(6%)
|
2%
|
* Growth in Emerging Markets offset declines
elsewhere
|
Others
|
|
104
|
(21%)
|
(18%)
|
* Continued impact of generic competition
|
Financial performance
Table 9: Reported Profit and
Loss
|
|
H1 2024
|
H1 2023
|
%
Change
|
Q2 2024
|
Q2 2023
|
% Change
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
Total
Revenue
|
|
25,617
|
22,295
|
15
|
18
|
12,938
|
11,416
|
13
|
17
|
- Product Sales
|
|
24,629
|
21,448
|
15
|
18
|
12,452
|
10,882
|
14
|
18
|
- Alliance Revenue
|
|
939
|
627
|
50
|
50
|
482
|
341
|
42
|
42
|
- Collaboration Revenue
|
|
49
|
220
|
(78)
|
(78)
|
4
|
193
|
(98)
|
(98)
|
Cost of sales
|
|
(4,401)
|
(3,865)
|
14
|
17
|
(2,183)
|
(1,960)
|
11
|
17
|
Gross
profit
|
|
21,216
|
18,430
|
15
|
18
|
10,755
|
9,456
|
14
|
17
|
Distribution expense
|
|
(267)
|
(265)
|
1
|
3
|
(132)
|
(131)
|
1
|
4
|
R&D expense
|
|
(5,791)
|
(5,278)
|
10
|
10
|
(3,008)
|
(2,667)
|
13
|
13
|
SG&A expense
|
|
(9,424)
|
(9,045)
|
4
|
6
|
(4,929)
|
(4,986)
|
(1)
|
1
|
Other operating income & expense
|
|
127
|
1,163
|
(89)
|
(89)
|
60
|
784
|
(92)
|
(92)
|
Operating
profit
|
|
5,861
|
5,005
|
17
|
25
|
2,746
|
2,456
|
12
|
20
|
Net finance expense
|
|
(645)
|
(654)
|
(1)
|
(4)
|
(343)
|
(367)
|
(7)
|
(7)
|
Joint ventures and associates
|
|
(19)
|
(1)
|
n/m
|
n/m
|
(6)
|
(1)
|
n/m
|
n/m
|
Profit before
tax
|
|
5,197
|
4,350
|
19
|
29
|
2,397
|
2,088
|
15
|
24
|
Taxation
|
|
(1,089)
|
(726)
|
50
|
62
|
(469)
|
(268)
|
75
|
90
|
Tax
rate
|
|
21%
|
17%
|
|
|
20%
|
13%
|
|
|
Profit after
tax
|
|
4,108
|
3,624
|
13
|
23
|
1,928
|
1,820
|
6
|
15
|
Earnings per
share
|
|
$2.65
|
$2.34
|
13
|
23
|
$1.24
|
$1.17
|
6
|
15
|
Table 10: Reconciliation of Reported
Profit before tax to EBITDA
|
|
H1 2024
|
H1 2023
|
% Change
|
Q2 2024
|
Q2 2023
|
% Change
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
Reported
Profit before tax
|
|
5,197
|
4,350
|
19
|
29
|
2,397
|
2,088
|
15
|
24
|
Net finance expense
|
|
645
|
654
|
(1)
|
(4)
|
343
|
367
|
(7)
|
(7)
|
Joint ventures and associates
|
|
19
|
1
|
n/m
|
n/m
|
6
|
1
|
n/m
|
n/m
|
Depreciation, amortisation and
impairment
|
|
2,534
|
2,778
|
(9)
|
(9)
|
1,279
|
1,276
|
-
|
1
|
EBITDA
|
|
8,395
|
7,783
|
8
|
13
|
4,025
|
3,732
|
8
|
14
|
Table 11: Reconciliation of Reported to
Core financial measures: H1 2024[7]
H1 2024
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Other
|
Core
|
Core
%
Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross
profit
|
|
21,216
|
36
|
19
|
-
|
21,271
|
14
|
17
|
Product Sales
Gross Margin
|
|
82%
|
|
|
|
82%
|
-1pp
|
-1pp
|
Distribution expense
|
|
(267)
|
-
|
-
|
-
|
(267)
|
1
|
3
|
R&D expense
|
|
(5,791)
|
177
|
39
|
5
|
(5,570)
|
14
|
15
|
%
of Total Revenue
|
|
23%
|
|
|
|
22%
|
-
|
+1pp
|
SG&A expense
|
|
(9,424)
|
138
|
1,884
|
254
|
(7,148)
|
13
|
15
|
%
of Total Revenue
|
|
37%
|
|
|
|
28%
|
+1pp
|
+1pp
|
Total operating expense
|
|
(15,482)
|
315
|
1,923
|
259
|
(12,985)
|
13
|
15
|
Other operating income & expense
|
|
127
|
(2)
|
-
|
-
|
125
|
(89)
|
(89)
|
Operating
profit
|
|
5,861
|
349
|
1,942
|
259
|
8,411
|
2
|
7
|
Operating Margin
|
|
23%
|
|
|
|
33%
|
-4pp
|
-3pp
|
Net finance expense
|
|
(645)
|
-
|
-
|
115
|
(530)
|
6
|
3
|
Taxation
|
|
(1,089)
|
(80)
|
(368)
|
(71)
|
(1,608)
|
13
|
19
|
EPS
|
|
$2.65
|
$0.17
|
$1.01
|
$0.20
|
$4.03
|
(1)
|
5
|
Table 12: Reconciliation of Reported to
Core financial measures: Q2 20247
Q2 2024
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Other
|
Core
|
Core
%
Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross
profit
|
|
10,755
|
16
|
9
|
-
|
10,780
|
13
|
17
|
Product Sales
Gross Margin
|
|
82%
|
|
|
|
83%
|
-
|
-
|
Distribution expense
|
|
(132)
|
-
|
-
|
-
|
(132)
|
1
|
4
|
R&D expense
|
|
(3,008)
|
97
|
35
|
4
|
(2,872)
|
12
|
13
|
%
of Total Revenue
|
|
23%
|
|
|
|
22%
|
-
|
+1pp
|
SG&A expense
|
|
(4,929)
|
41
|
943
|
210
|
(3,735)
|
13
|
16
|
%
of Total Revenue
|
|
38%
|
|
|
|
29%
|
-
|
-
|
Total operating expense
|
|
(8,069)
|
138
|
978
|
214
|
(6,739)
|
12
|
14
|
Other operating income & expense
|
|
60
|
-
|
-
|
-
|
60
|
(92)
|
(92)
|
Operating
profit
|
|
2,746
|
154
|
987
|
214
|
4,101
|
(4)
|
1
|
Operating Margin
|
|
21%
|
|
|
|
32%
|
-6pp
|
-5pp
|
Net finance expense
|
|
(343)
|
-
|
-
|
58
|
(285)
|
10
|
10
|
Taxation
|
|
(469)
|
(35)
|
(185)
|
(52)
|
(741)
|
7
|
13
|
EPS
|
|
$1.24
|
$0.08
|
$0.51
|
$0.15
|
$1.98
|
(8)
|
(3)
|
|
|
|
|
|
|
|
|
|
|
| |
Gross profit
‒
The calculation of Reported and Core Product Sales Gross
Margin excludes the impact of Alliance Revenue and Collaboration
Revenue
‒
The change in Product Sales Gross Margin (Reported and Core)
in H1 2024 was impacted by:
‒
Positive effects from product mix. The increased contribution
from Rare Disease and Oncology medicines had a positive impact on
the Product Sales Gross Margin
‒
Dilutive effects from product mix. The rising contribution of
Product Sales with profit sharing arrangements (Lynparza, Enhertu, Tezspire, Koselugo) has a negative
impact on Product Sales Gross Margin because AstraZeneca records
Product Sales in certain markets and pays away a share of the gross
profits to its collaboration partners. The growth in Beyfortus also has a dilutive impact
on Product Sales Gross Margin, as AstraZeneca is responsible for
manufacturing, and Sanofi is responsible for distribution.
AstraZeneca records its sales to Sanofi as Product Sales, and those
sales generate a lower Product Sales Gross Margin than the Company
average
‒
Dilutive effects from geographic mix. In Emerging Markets,
the Product Sales Gross Margin tends to be below the Company
average
‒
Variations in Product Sales Gross Margin performance between
periods can continue to be expected due to product seasonality,
foreign exchange fluctuations, and other effects
R&D expense
‒
The change in R&D expense (Reported and Core) in the
period was impacted by:
‒
Positive data read-outs for several high priority medicines
that have ungated late-stage trials
‒
Investment in platforms, new technology and capabilities to
enhance R&D capabilities
‒
Addition of R&D projects following completion of
previously announced business development activity including
Icosavax, Gracell and Fusion
‒
The change in Reported R&D expense was also impacted by
intangible asset impairments in the prior period
SG&A expense
‒
The change in SG&A expense (Reported and Core) in the
period was driven primarily by market development activities for
launches and to support continued growth in existing brands
Other operating income and expense
‒ In
the prior year period, Other operating income and expense included
a $241m gain on the disposal of the US rights to Pulmicort Flexhaler and a $712m gain
relating to updates to contractual arrangements for Beyfortus
Net finance expense
‒
Core Net finance expense increased 6% (3% increase at CER)
principally due to the higher level of gross debt partially offset
by the higher level of cash and short-term investments.
Taxation
‒
The effective Reported Tax rate for
the six months to 30 June 2024 was 21% (H1 2023: 17%) and the
effective Core Tax rate was 20% (H1 2023: 18%)
‒
The cash tax paid for the six months
to 30 June 2024 was $1,337m (H1 2023: $1,061m), representing 26% of
Reported Profit before tax (H1 2023: 24%)
Dividend
‒ An
Interim dividend of $1 per share (77.6 pence, 10.79 SEK) has been
declared.
Table 13: Cash Flow summary
|
|
H1
2024
|
H1
2023
|
Change
|
|
|
$m
|
$m
|
$m
|
Reported Operating profit
|
|
5,861
|
5,005
|
856
|
Depreciation, amortisation and
impairment
|
|
2,534
|
2,778
|
(244)
|
Movement in working capital and short-term
provisions
|
|
(584)
|
(747)
|
163
|
Gains on disposal of intangible
assets
|
|
(21)
|
(249)
|
228
|
Fair value movements on contingent
consideration arising from
business combinations
|
|
251
|
202
|
49
|
Non-cash and other movements
|
|
(550)
|
(594)
|
44
|
Interest paid
|
|
(583)
|
(483)
|
(100)
|
Taxation paid
|
|
(1,337)
|
(1,061)
|
(276)
|
Net cash
inflow from operating activities
|
|
5,571
|
4,851
|
720
|
Net cash
inflow before financing activities
|
|
286
|
3,085
|
(2,799)
|
Net cash
inflow/(outflow) from financing activities
|
|
806
|
(3,550)
|
4,356
|
The change in Net cash inflow before financing
activities in the half year to 30 June 2024 is primarily driven by
the movement in Acquisitions of subsidiaries, net of cash acquired
and initial investment, of $2,771m, and relates to the acquisition
of Gracell Biotechnologies, Inc. for $774m and acquisition of
Fusion Pharmaceuticals Inc., for $1,997m as compared to the
acquisition of Neogene Therapeutics, Inc. for $189m in H1
2023.
The increase in Net cash inflow/(outflow) from
financing activities of $4,356m is primarily driven by the increase
in Issue of loans and borrowings of $1,160m, by the decrease in
Repayment of loans and borrowings of $765m and the increase in
Movement in short-term borrowings of $2,431m mainly due to the
Commercial paper issued during the half year for
$2,453m.
Capital expenditure
Capital expenditure amounted to $799m in H1
2024 (H1 2023: $517m). Capital expenditure is expected to increase
substantially in 2024, driven by investment in several major
manufacturing projects and continued investment in technology
upgrades.
Table 14: Net debt summary
|
At 30
Jun 2024
|
At 31
Dec 2023
|
At 30
Jun 2023
|
|
$m
|
$m
|
$m
|
Cash and cash equivalents
|
6,916
|
5,840
|
5,664
|
Other investments
|
160
|
122
|
148
|
Cash and
investments
|
7,076
|
5,962
|
5,812
|
Overdrafts and short-term borrowings
|
(596)
|
(515)
|
(421)
|
Commercial paper
|
(2,453)
|
-
|
-
|
Lease liabilities
|
(1,241)
|
(1,128)
|
(953)
|
Current instalments of loans
|
(2,018)
|
(4,614)
|
(4,135)
|
Non-current instalments of loans
|
(27,225)
|
(22,365)
|
(24,329)
|
Interest-bearing loans and borrowings
(Gross debt)
|
(33,533)
|
(28,622)
|
(29,838)
|
Net derivatives
|
133
|
150
|
56
|
Net
debt
|
(26,324)
|
(22,510)
|
(23,970)
|
Net debt increased by $3,814m in the six months
to 30 June 2024 to $26,324m. Details of the committed undrawn bank
facilities are disclosed within the going concern section of Note
1. Details of the Company's solicited credit ratings and further
details on Net debt are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a
balance between the interests of the business, financial creditors
and the Company's shareholders. The Company's capital allocation
priorities include: investing in the business and pipeline;
maintaining a strong, investment-grade credit rating; potential
value-enhancing business development opportunities; and supporting
the progressive dividend policy.
In approving the declaration of dividends, the
Board considers both the liquidity of the company and the level of
reserves legally available for distribution. Dividends are paid to
shareholders from AstraZeneca PLC, a Group holding company with no
direct operations. The ability of AstraZeneca PLC to make
shareholder distributions is dependent on the creation of profits
for distribution and the receipt of funds from subsidiary
companies. The consolidated Group reserves set out in the Condensed
consolidated statement of financial position do not reflect the
profit available for distribution to the shareholders of
AstraZeneca PLC.
Summarised financial information for guarantee of
securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance")
is the issuer of 0.7% Notes due 2024, 1.2% Notes due 2026, 4.8%
Notes due 2027, 4.875% Notes due 2028, 1.75% Notes due 2028, 4.85%
Notes due 2029, 4.9% Notes due 2030, 4.9% Notes due 2031, 2.25%
Notes due 2031, 4.875% Notes due 2033 and 5% Notes due 2034 (the
"AstraZeneca Finance Notes"). Each series of AstraZeneca Finance
Notes has been fully and unconditionally guaranteed by AstraZeneca
PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each
of the guarantees issued by AstraZeneca PLC is full and
unconditional and joint and several.
The AstraZeneca Finance Notes are senior
unsecured obligations of AstraZeneca Finance and rank equally with
all of AstraZeneca Finance's existing and future senior unsecured
and unsubordinated indebtedness. The guarantee by AstraZeneca PLC
of the AstraZeneca Finance Notes is the senior unsecured obligation
of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's
existing and future senior unsecured and unsubordinated
indebtedness. Each guarantee by AstraZeneca PLC is effectively
subordinated to any secured indebtedness of AstraZeneca PLC to the
extent of the value of the assets securing such indebtedness. The
AstraZeneca Finance Notes are structurally subordinated to
indebtedness and other liabilities of the subsidiaries of
AstraZeneca PLC, none of which guarantee the AstraZeneca Finance
Notes.
AstraZeneca PLC manages substantially all of
its operations through divisions, branches and/or investments in
subsidiaries and affiliates. Accordingly, the ability of
AstraZeneca PLC to service its debt and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates,
branches and divisions, whether by dividends, distributions, loans
or otherwise.
Please refer to the Consolidated financial
statements of AstraZeneca PLC in our Annual Report on Form 20‑F as
filed with the SEC and information contained herein for further
financial information regarding AstraZeneca PLC and its
consolidated subsidiaries. For further details, terms and
conditions of the AstraZeneca Finance Notes please refer to
AstraZeneca PLC's reports on Form 6-K furnished to the SEC on 22
February 2024, 3 March 2023 and 28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of
Regulation S-X under the Securities Act of 1933, as amended (the
"Securities Act"), we present below the summary financial
information for AstraZeneca PLC, as Guarantor, excluding its
consolidated subsidiaries, and AstraZeneca Finance, as the issuer,
excluding its consolidated subsidiaries. The following summary
financial information of AstraZeneca PLC and AstraZeneca Finance is
presented on a combined basis and transactions between the
combining entities have been eliminated. Financial information for
non-guarantor entities has been excluded. Intercompany balances and
transactions between the obligor group and the non-obligor
subsidiaries are presented on separate lines.
Table 15: Obligor group summarised
Statement of comprehensive income
|
|
H1 2024
|
H1 2023
|
|
|
$m
|
$m
|
Total Revenue
|
|
-
|
-
|
Gross profit
|
|
-
|
-
|
Operating loss
|
|
-
|
(2)
|
Loss for the period
|
|
(545)
|
(480)
|
Transactions with subsidiaries that are not
issuers or guarantors
|
|
964
|
9,487
|
Table 16: Obligor group summarised
Statement of financial position
|
|
At 30 Jun
2024
|
At 30 Jun
2023
|
|
|
$m
|
$m
|
Current assets
|
|
13
|
7
|
Non-current assets
|
|
-
|
-
|
Current liabilities
|
|
(4,795)
|
(4,091)
|
Non-current liabilities
|
|
(27,133)
|
(24,165)
|
Amounts due from subsidiaries that are not
issuers or guarantors
|
|
20,730
|
15,761
|
Amounts due to subsidiaries that are not
issuers or guarantors
|
|
-
|
(290)
|
Foreign exchange
The Company's transactional currency exposures
on working capital balances, which typically extend for up to three
months, are hedged where practicable using forward foreign exchange
contracts against the individual companies' reporting currency.
Foreign exchange gains and losses on forward contracts transacted
for transactional hedging are taken to profit or to Other
comprehensive income if the contract is in a designated cashflow
hedge. In addition, the Company's external dividend payments, paid
principally in pound sterling and Swedish krona, are fully hedged
from announcement to payment date.
Table 17: Currency
sensitivities
The Company provides the following information
on currency-sensitivity:
|
|
|
Average
rates vs.
USD
|
|
Annual impact ($m)
of 5% strengthening (FY 2024 average
rate vs. FY 2023 average) [8]
|
Currency
|
Primary Relevance
|
|
FY
2023[9]
|
YTD
2024[10]
|
Change
(%)
|
June 2024[11]
|
Change
(%)
|
|
Total Revenue
|
Core Operating Profit
|
EUR
|
Total Revenue
|
|
0.92
|
0.93
|
(0)
|
0.93
|
(0)
|
|
397
|
179
|
CNY
|
Total Revenue
|
|
7.09
|
7.23
|
(2)
|
7.27
|
(3)
|
|
322
|
182
|
JPY
|
Total Revenue
|
|
140.60
|
152.26
|
(8)
|
158.03
|
(11)
|
|
177
|
119
|
Other[12]
|
|
|
|
|
|
|
|
|
453
|
227
|
GBP
|
Operating expense
|
|
0.80
|
0.79
|
2
|
0.79
|
2
|
|
60
|
(126)
|
SEK
|
Operating expense
|
|
10.61
|
10.54
|
1
|
10.49
|
1
|
|
9
|
(63)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Related-party transactions
There have been no significant related-party
transactions in the period.
Principal risks and uncertainties
The Principal Risks and uncertainties facing
the Group are set out on pages 54 to 57 of the Annual Report and
Form 20-F Information 2023, and summarised below. They are not
expected to change in respect of the second six months of the
financial year and remain appropriate for the Group. In summary,
the principal risks and uncertainties listed in the Annual Report
and 20-F Information 2023 are:
1. Product pipeline: failure or delay in
the delivery of AstraZeneca's pipeline or launch of new medicines;
failure to meet regulatory or ethical requirements for medicine
development or approval
2. Commercialisation risks: pricing,
affordability, access and competitive pressures; failures or delays
in the quality or execution of the Group's commercial
strategies
3. Supply-chain and business-execution
risks: failure to maintain supply of compliant, quality medicines;
failure in information technology or cybersecurity; failure to
attract, develop, engage and retain a diverse, talented and capable
workforce
4. Legal, regulatory and compliance
risks: safety and efficacy of marketed medicines is questioned;
adverse outcome of litigation and / or governmental investigations;
IP risks related to our products
5. Economic and financial risks: failure
to achieve strategic plans or meet targets or expectations;
geopolitical and / or macroeconomic volatility disrupts the
operation of our global business
Sustainability
AstraZeneca released
its first
Sustainability Impact Publication as a complement to its ninth annual
Sustainability Report. This
publication spotlights the diverse ways in which the Company is
contributing to the health of people, society and the
planet.
Access to healthcare
‒
At the 77th World Health Assembly (WHA)
in Geneva, Switzerland in May, AstraZeneca convened Ministers of
Health, industry, civil society and patient groups. Areas of focus
for engagement, led by Ruud Dobber, EVP BioPharmaceuticals,
included the need to increase early action to prevent, diagnose and
treat disease and to accelerate collaboration to build resilient,
equitable and net zero health systems
‒
At the WHA, AstraZeneca launched the expansion of
its flagship Healthy Heart Africa programme to include chronic kidney disease as well as
cardiovascular disease, recognising the growing burden of
non-communicable diseases (NCDs) in Africa. As of May 2024, HHA has
conducted more than 57 million screenings for high blood pressure
and identified more than 11.3 million elevated readings, with 4.5
million patients diagnosed with hypertension since
launch
‒
Also at the WHA, the Lung Ambition Alliance, of which the
Company is a founding member, launched the Saving Lives from Lung
Cancer platform and a calculator tool developed by AstraZeneca to
support policymakers and the lung cancer community in identifying
high-risk populations for early intervention
‒
The Partnership for Health
System Sustainability and Resilience (PHSSR) held its third Summit during the Abu Dhabi
Global Healthcare Week in May, bringing together more than 200
healthcare leaders from the Middle East, Africa and beyond
including three Ministers of Health and 29 speakers, to drive
forward the dialogue on investing in strengthening health systems.
PHSSR also hosted local events in Taiwan, Portugal and the
Netherlands during the quarter. In addition, insights from
the PHSSR Asia-Pacific report were shared with a delegation from Korea at
WHA
‒
A survey of more than 600 employees in 16
countries where the Young Health Programme
(YHP) is active showed that more than 95% of
employees feel proud to be associated with the YHP. With its
expansion into the Philippines, the programme is now active in 41
countries globally. In recognition of the impact of the YHP,
AstraZeneca was the only corporate partner invited to speak at
UNICEF's Annual Meeting attended by UNICEF's 33 CEOs and their
Board Chairs in high-income countries
‒
In June, the Company expanded its partnership
with Direct Relief, approving
the humanitarian organisation as a global medicine donation
partner, enabling medicine donation to support global humanitarian
relief efforts
Environmental protection
‒
AstraZeneca received multiple recognitions for its sustainability
leadership this quarter, including retaining its EcoVadis Gold
Medal ranking for the second consecutive year. This reflects its
place in the top three percent of companies evaluated on
environment, labour and human rights, ethics and sustainable
procurement. The Company was also recognised in
the 2024 FT Europe Climate Leaders list, where it was the top pharmaceutical company for the
second year in a row
‒
AstraZeneca is collaborating with the
World Business Council for Sustainable Development
and its peers to develop a Roadmap to
Nature Positive for the pharmaceutical
sector, announced in May. The Roadmap will offer sector-specific
guidance to accelerate toward nature positive, in alignment with
the Taskforce for Nature-related Financial Disclosures,
Science-based Targets Network and the EU's Corporate Sustainability
Reporting Directive
‒
Pam Cheng, Executive Vice President of Global
Operations and IT and Chief Sustainability Officer, joined a Global
Health Leaders panel at the inaugural Climate and Health Day of the US Climate
Action Summit. Leaders from government,
industry, philanthropy and finance discussed the critical need to
drive coordinated action on the climate and health nexus
Ethics and transparency
‒
AstraZeneca shared a new Diversity in Clinical
Trials Standard internally for use across all therapy areas in
R&D. This outlines the Company's mandatory principles on
diversity for all AstraZeneca-sponsored clinical trials, in line
with regulatory requirements, and reflects the Company's unwavering
commitment to ensuring its clinical trials are representative
of diverse populations
‒
Approximately 6,500 colleagues across 10 regions
and 16 business units took the time to respond to AstraZeneca's
second employee Ethics Survey. An analysis of 2023 results showed
employee feedback continues to be positive, with 97% of respondents
confirming they know how to raise an ethical concern and 87%
confirming that it is easy to do the right thing in their
day-to-day work
‒
The Company released new guidance on the
selection, design, installation and maintenance of solar
Photovoltaic (PV) power systems, which highlights the importance of
conducting due diligence on human rights risks associated with new
solar PV projects
Research and development
This section covers R&D events and
milestones that have occurred since the prior results announcement
on 25 April 2024, up to and including events on 24 July
2024.
A comprehensive view of AstraZeneca's pipeline
of medicines in human trials can be found in the latest Clinical
Trials Appendix, available on www.astrazeneca.com/investor-relations.
The Clinical Trials Appendix includes tables with details of the
ongoing clinical trials for AstraZeneca medicines and new molecular
entities in the pipeline.
Oncology
AstraZeneca presented new data across its
diverse portfolio of cancer medicines at two major medical
congresses since the prior results announcement: the American
Society of Clinical Oncology (ASCO) in May and June 2024 and
European Hematology Association (EHA) in June 2024.
At ASCO, AstraZeneca presented more than 100
abstracts featuring 25 approved and potential new medicines across
the Company's diverse oncology portfolio and pipeline, including
two late-breaking plenary presentations, a special late-breaking
abstract session presentation and 15 oral presentations. At EHA,
AstraZeneca presented 17 abstracts including one oral presentation
and 10 posters across one approved and four investigational
products.
Tagrisso
Event
|
|
|
Commentary
|
Presentation: ASCO
|
LAURA
|
|
Primary analysis of the Phase III LAURA trial,
presented at ASCO, showed Tagrisso reduced the risk of disease
progression or death by 84% compared to placebo (HR 0.16, 95% CI
0.10-0.24, p<0.001) as assessed by BICR. Median PFS was 39.1
months in patients treated with Tagrisso versus 5.6 months for
placebo.
|
sNDA acceptance and Priority Review
|
US
|
|
For the treatment of adult patients with
unresectable, Stage III EGFRm NSCLC after chemoradiotherapy.
(LAURA, June 2024)
|
Approvals
|
Japan, China
|
|
Tagrisso with the
addition of pemetrexed and platinum-based chemotherapy for the
1st-line treatment of adult patients with locally advanced or
metastatic EGFRm NSCLC
whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
(FLAURA2, June 2024)
|
Approval
|
Europe
|
|
Tagrisso with the
addition of pemetrexed and platinum-based chemotherapy for the
1st-line treatment of adult patients with advanced EGFRm NSCLC whose tumours have exon 19
deletions or exon 21 (L858R) mutations. (FLAURA2, July
2024)
|
Imfinzi
and Imjudo
Event
|
|
|
Commentary
|
Presentation: ASCO
|
ADRIATIC
|
|
Planned interim analysis of the Phase III
ADRIATIC trial, presented at ASCO, demonstrated Imfinzi reduced the risk of death by
27% versus placebo (OS HR 0.73, 95% CI 0.57-0.93, p=0.0104) with an
estimated 57% of patients treated with Imfinzi alive at three years compared
to 48% on placebo. (June 2024)
|
Approval
|
US
|
|
Imfinzi in
combination with carboplatin and paclitaxel followed by
Imfinzi monotherapy for
treatment for adult patients with primary advanced or recurrent
endometrial cancer that is mismatch repair deficient. (DUO-E, June
2024)
|
Phase III data readout
|
NIAGARA
|
|
Met primary endpoint, with Imfinzi in
combination with chemotherapy demonstrating a statistically
significant and clinically meaningful improvement in the primary
endpoint of event-free survival and the key secondary endpoint of
OS versus neoadjuvant chemotherapy for patients with
muscle-invasive bladder cancer. (June 2024)
|
Trial update
|
BR.31
|
|
BR.31 Phase III trial for Imfinzi in early-stage (IB-IIIA) NSCLC
after complete tumour resection in patients whose tumours express
PD-L1 on 25% or more tumour cells did not achieve statistical
significance for the primary endpoint of disease-free survival
versus placebo. (June 2024)
|
CHMP positive opinion
|
Europe
|
|
Imfinzi plus
chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi for patients with mismatch
repair proficient disease. Imfinzi plus
chemotherapy followed by Imfinzi alone for patients with
mismatch repair deficient disease. (DUO‑E, July 2024)
|
Lynparza
Event
|
|
|
Commentary
|
CHMP positive opinion
|
Europe
|
|
Imfinzi plus
chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi for patients with mismatch
repair proficient disease. (DUO-E, July 2024)
|
Enhertu
Event
|
|
|
Commentary
|
Phase III readout and presentation:
ASCO
|
DESTINY-Breast06
|
|
Met primary endpoint, demonstrating
Enhertu resulted in a
statistically significant and clinically meaningful improvement in
PFS in HR-positive, HER2-low metastatic breast cancer following one
or more lines of endocrine therapy. (April 2024)
Primary analysis of the Phase III
DESTINY-Breast06 trial, presented at ASCO, demonstrated
Enhertu resulted in a
statistically significant and clinically meaningful improvement in
PFS compared to standard-of-care chemotherapy in patients with
HR-positive, HER2-low metastatic breast cancer (HR 0.62, 95% CI
0.51-0.74, p<0.0001). Enhertu also demonstrated a
statistically significant and clinically meaningful improvement in
the overall trial population (patients with HR-positive, HER2-low
and HER2-ultralow disease) (HR 0.63, 95% CI 0.53-0.75,
p<0.0001). (June 2024)
|
Calquence
Event
|
|
|
Commentary
|
Phase III readout and presentation:
EHA
|
ECHO
|
|
Met primary endpoint with Calquence combination regimen
demonstrating a statistically significant and clinically meaningful
improvement in PFS in 1st-line mantle cell lymphoma. (May
2024)
Interim analysis of the Phase III ECHO trial,
presented at EHA, demonstrated Calquence in combination with
standard-of-care chemoimmunotherapy, bendamustine and rituximab,
resulted in a statistically significant and clinically meaningful
27% reduction in risk of progression or death versus standard of
care in previously untreated adult patients with mantle cell
lymphoma (HR 0.73, 95% CI 0.57-0.94, p=0.016). The secondary
endpoint of OS showed a favourable trend for the Calquence combination compared to
chemoimmunotherapy (HR 0.86; 95% CI 0.65-1.13; p=0.2743, not
statistically significant, follow-up continues). (June
2024)
|
Truqap
Event
|
|
|
Commentary
|
Phase III trial update
|
CAPItello-290
|
|
CAPItello-290 Phase III trial for Truqap in combination with paclitaxel
in patients with locally advanced or metastatic TNBC did not meet
the dual primary endpoints of improvement in OS vs paclitaxel in
combination with placebo in either the overall trial population or
in a subgroup of patients with tumours harbouring specific
biomarker alterations (PIK3CA, AKT1 or PTEN). (June 2024)
|
Approval
|
Europe
|
|
In combination with Faslodex for the treatment of adult
patients with estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast
cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence
or progression on or after an endocrine-based regimen.
(CAPItello-291, June 2024)
|
Datopotamab deruxtecan (Dato-DXd)
Event
|
|
|
Commentary
|
Phase IIII trial update
|
TROPION-Lung01
|
|
Dual primary endpoint of improvement in overall
survival for Dato-DXd versus docetaxel not met. Numerical
improvement in overall survival compared to docetaxel in the
overall trial population of patients with locally advanced or
metastatic NSCLC. In the prespecified subgroup of patients with
non-squamous NSCLC, Dato-DXd showed a clinically meaningful
improvement in OS compared to docetaxel. (May 2024)
|
BioPharmaceuticals - CVRM
Farxiga
Event
|
|
|
Commentary
|
Approval
|
US
|
|
Improvement of glycaemic control in paediatric
patients with type-2 diabetes aged 10 years and older (T2NOW,
June 2024)
|
AZD0780 (oral PCSK9)
Event
|
|
|
Commentary
|
Presentation: European Atherosclerosis
Society
|
|
|
Positive Phase I data demonstrating a
statistically significant reduction of 52% in LDL-C levels on top
of rosuvastatin treatment, with 78% total reduction from baseline,
in treatment-naive participants with hypercholesterolaemia. (May
2024)
|
BioPharmaceuticals - R&I
Tezspire
Event
|
|
|
Commentary
|
Presentation: American Thoracic
Society
|
COURSE
|
|
Results from the COURSE Phase II trial
demonstrated that treatment with Tezspire led to a 17% numerical
reduction in the annual rate of moderate or severe COPD
exacerbations compared to placebo at week 52. In patients with
blood eosinophil counts of 150 cell/µl or more, treatment with
Tezspire led to a
nominally significant reduction of 37% in the rate of moderate or
severe exacerbations compared to placebo. (May 2024)
|
Phase III readout
|
DIRECTION
|
|
Met the primary endpoint, demonstrating a
statistically significant reduction in annual asthma exacerbation
rate (AAER) over 52 weeks compared to placebo in patients in China
with a history of uncontrolled asthma. (July 2024)
|
BioPharmaceuticals - V&I
sipavibart (COVID-19 mAb)
Event
|
|
|
Commentary
|
Phase III readout
|
SUPERNOVA
|
|
Positive high-level results from the SUPERNOVA
Phase III trial showed sipavibart demonstrated a statistically
significant reduction in the incidence of symptomatic
COVID‑19 in an
immunocompromised patient population. The trial was conducted
during an evolving variant landscape in which COVID-19 cases
captured over the course of the trial were caused by several
different SARS-CoV-2 variants. (May 2024)
|
Rare Disease
AstraZeneca presented new clinical data from
the industry's largest and broadest amyloidosis pipeline at the
International Symposium on Amyloidosis (ISA) in May 2024. Clinical
data was presented on ALXN2220 and anselamimab, which are being
evaluated in Phase III clinical trials for ATTR and light chain
(AL) amyloidosis, respectively.
Interim financial statements
Table 18: Condensed consolidated statement
of comprehensive income: H1 2024
For the half year ended 30
June
|
|
2024
|
2023
|
|
|
$m
|
$m
|
Total
Revenue
|
|
25,617
|
22,295
|
Product
Sales
|
|
24,629
|
21,448
|
Alliance
Revenue
|
|
939
|
627
|
Collaboration
Revenue
|
|
49
|
220
|
Cost of sales
|
|
(4,401)
|
(3,865)
|
Gross
profit
|
|
21,216
|
18,430
|
Distribution expense
|
|
(267)
|
(265)
|
Research and development expense
|
|
(5,791)
|
(5,278)
|
Selling, general and administrative
expense
|
|
(9,424)
|
(9,045)
|
Other operating income and expense
|
|
127
|
1,163
|
Operating
profit
|
|
5,861
|
5,005
|
Finance income
|
|
211
|
141
|
Finance expense
|
|
(856)
|
(795)
|
Share of after tax losses in associates and
joint ventures
|
|
(19)
|
(1)
|
Profit before
tax
|
|
5,197
|
4,350
|
Taxation
|
|
(1,089)
|
(726)
|
Profit for the
period
|
|
4,108
|
3,624
|
Other
comprehensive income:
|
|
|
|
Items that will not be reclassified to
profit or loss:
|
|
|
|
Remeasurement of the defined benefit pension
liability
|
|
101
|
7
|
Net gains/(losses) on equity investments
measured at fair value through other comprehensive
income
|
|
89
|
(48)
|
Fair value movements related to own credit risk
on bonds designated as fair value through profit or loss
|
|
12
|
4
|
Tax on items that will not be reclassified to
profit or loss
|
|
(27)
|
(5)
|
|
|
175
|
(42)
|
Items that may be
reclassified subsequently to profit or loss:
|
|
|
|
Foreign exchange arising on
consolidation
|
|
(554)
|
105
|
Foreign exchange arising on designated
liabilities in net investment hedges
|
|
(96)
|
(101)
|
Fair value movements on cash flow
hedges
|
|
(138)
|
89
|
Fair value movements on cash flow hedges
transferred to profit and loss
|
|
102
|
(71)
|
Fair value movements on derivatives designated
in net investment hedges
|
|
45
|
40
|
Gains/(costs) of hedging
|
|
14
|
(1)
|
Tax on items that may be reclassified
subsequently to profit or loss
|
|
38
|
12
|
|
|
(589)
|
73
|
Other
comprehensive (expense)/income, net of tax
|
|
(414)
|
31
|
Total
comprehensive income for the period
|
|
3,694
|
3,655
|
Profit
attributable to:
|
|
|
|
Owners of the Parent
|
|
4,106
|
3,621
|
Non-controlling interests
|
|
2
|
3
|
|
|
4,108
|
3,624
|
Total
comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
|
3,692
|
3,652
|
Non-controlling interests
|
|
2
|
3
|
|
|
3,694
|
3,655
|
Basic earnings per $0.25 Ordinary
Share
|
|
$2.65
|
$2.34
|
Diluted earnings per $0.25 Ordinary
Share
|
|
$2.63
|
$2.32
|
Weighted average number of Ordinary
Shares in issue (millions)
|
|
1,549
|
1,549
|
Diluted weighted average number of
Ordinary Shares in issue (millions)
|
|
1,560
|
1,560
|
Table 19: Condensed consolidated statement
of comprehensive income: Q2 2024
For the quarter ended 30
June
|
|
Unreviewed[13]
|
Unreviewed
|
|
|
2024
|
2023
|
|
|
$m
|
$m
|
Total
Revenue
|
|
12,938
|
11,416
|
Product
Sales
|
|
12,452
|
10,882
|
Alliance
Revenue
|
|
482
|
341
|
Collaboration
Revenue
|
|
4
|
193
|
Cost of sales
|
|
(2,183)
|
(1,960)
|
Gross
profit
|
|
10,755
|
9,456
|
Distribution expense
|
|
(132)
|
(131)
|
Research and development expense
|
|
(3,008)
|
(2,667)
|
Selling, general and administrative
expense
|
|
(4,929)
|
(4,986)
|
Other operating income and expense
|
|
60
|
784
|
Operating
profit
|
|
2,746
|
2,456
|
Finance income
|
|
100
|
64
|
Finance expense
|
|
(443)
|
(431)
|
Share of after tax losses in associates and
joint ventures
|
|
(6)
|
(1)
|
Profit before
tax
|
|
2,397
|
2,088
|
Taxation
|
|
(469)
|
(268)
|
Profit for the
period
|
|
1,928
|
1,820
|
Other
comprehensive income:
|
|
|
|
Items that will not be reclassified to
profit or loss:
|
|
|
|
Remeasurement of the defined benefit pension
liability
|
|
(43)
|
17
|
Net gains/(losses) on equity investments
measured at fair value through other comprehensive
income
|
|
54
|
(94)
|
Fair value movements related to own credit risk
on bonds designated as fair value through profit or loss
|
|
12
|
2
|
Tax on items that will not be reclassified to
profit or loss
|
|
12
|
(29)
|
|
|
35
|
(104)
|
Items that may be
reclassified subsequently to profit or loss:
|
|
|
|
Foreign exchange arising on
consolidation
|
|
(39)
|
(209)
|
Foreign exchange arising on designated
liabilities in net investment hedges
|
|
2
|
(94)
|
Fair value movements on cash flow
hedges
|
|
(52)
|
33
|
Fair value movements on cash flow hedges
transferred to profit and loss
|
|
32
|
4
|
Fair value movements on derivatives designated
in net investment hedges
|
|
23
|
24
|
Costs of hedging
|
|
(1)
|
(1)
|
Tax on items that may be reclassified
subsequently to profit or loss
|
|
3
|
-
|
|
|
(32)
|
(243)
|
Other
comprehensive income/(expense), net of tax
|
|
3
|
(347)
|
Total
comprehensive income for the period
|
|
1,931
|
1,473
|
Profit
attributable to:
|
|
|
|
Owners of the Parent
|
|
1,927
|
1,818
|
Non-controlling interests
|
|
1
|
2
|
|
|
1,928
|
1,820
|
Total
comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
|
1,930
|
1,471
|
Non-controlling interests
|
|
1
|
2
|
|
|
1,931
|
1,473
|
Basic earnings per $0.25 Ordinary
Share
|
|
$1.24
|
$1.17
|
Diluted earnings per $0.25 Ordinary
Share
|
|
$1.24
|
$1.17
|
Weighted average number of Ordinary
Shares in issue (millions)
|
|
1,550
|
1,550
|
Diluted weighted average number of
Ordinary Shares in issue (millions)
|
|
1,560
|
1,560
|
Table 20: Condensed consolidated statement
of financial position
|
|
Reviewed[14]
At 30 Jun
2024
|
Audited
At 31 Dec
2023
|
Reviewed
At 30 Jun
2023
|
|
|
$m
|
$m
|
$m
|
Assets
|
|
|
|
|
Non-current
assets
|
|
|
|
|
Property, plant and equipment
|
|
9,630
|
9,402
|
8,675
|
Right-of-use assets
|
|
1,203
|
1,100
|
949
|
Goodwill
|
|
21,060
|
20,048
|
19,960
|
Intangible assets
|
|
39,426
|
38,089
|
38,326
|
Investments in associates and joint
ventures
|
|
264
|
147
|
72
|
Other investments
|
|
1,607
|
1,530
|
1,071
|
Derivative financial instruments
|
|
217
|
228
|
163
|
Other receivables
|
|
806
|
803
|
752
|
Deferred tax assets
|
|
4,734
|
4,718
|
3,736
|
|
|
78,947
|
76,065
|
73,704
|
Current
assets
|
|
|
|
|
Inventories
|
|
5,667
|
5,424
|
5,051
|
Trade and other receivables
|
|
11,047
|
12,126
|
11,092
|
Other investments
|
|
160
|
122
|
148
|
Derivative financial instruments
|
|
28
|
116
|
44
|
Income tax receivable
|
|
1,575
|
1,426
|
840
|
Cash and cash equivalents
|
|
6,916
|
5,840
|
5,664
|
|
|
25,393
|
25,054
|
22,839
|
Total
assets
|
|
104,340
|
101,119
|
96,543
|
Liabilities
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Interest-bearing loans and
borrowings
|
|
(5,067)
|
(5,129)
|
(4,556)
|
Lease liabilities
|
|
(292)
|
(271)
|
(231)
|
Trade and other payables
|
|
(20,463)
|
(22,374)
|
(19,738)
|
Derivative financial instruments
|
|
(51)
|
(156)
|
(83)
|
Provisions
|
|
(1,168)
|
(1,028)
|
(567)
|
Income tax payable
|
|
(1,525)
|
(1,584)
|
(1,200)
|
|
|
(28,566)
|
(30,542)
|
(26,375)
|
Non-current
liabilities
|
|
|
|
|
Interest-bearing loans and
borrowings
|
|
(27,225)
|
(22,365)
|
(24,329)
|
Lease liabilities
|
|
(949)
|
(857)
|
(722)
|
Derivative financial instruments
|
|
(61)
|
(38)
|
(68)
|
Deferred tax liabilities
|
|
(3,333)
|
(2,844)
|
(2,800)
|
Retirement benefit obligations
|
|
(1,326)
|
(1,520)
|
(1,078)
|
Provisions
|
|
(1,074)
|
(1,127)
|
(1,357)
|
Other payables
|
|
(2,208)
|
(2,660)
|
(2,398)
|
|
|
(36,176)
|
(31,411)
|
(32,752)
|
Total
liabilities
|
|
(64,742)
|
(61,953)
|
(59,127)
|
Net
assets
|
|
39,598
|
39,166
|
37,416
|
Equity
|
|
|
|
|
Capital and
reserves attributable to equity holders of the
Parent
|
|
|
|
|
Share capital
|
|
388
|
388
|
387
|
Share premium account
|
|
35,199
|
35,188
|
35,163
|
Other reserves
|
|
2,078
|
2,065
|
2,076
|
Retained earnings
|
|
1,847
|
1,502
|
(234)
|
|
|
39,512
|
39,143
|
37,392
|
Non-controlling interests
|
|
86
|
23
|
24
|
Total
equity
|
|
39,598
|
39,166
|
37,416
|
Table 21: Condensed
consolidated statement of changes in equity
|
|
Share
capital
|
Share
premium account
|
Other
reserves
|
Retained
earnings
|
Total attributable to owners of the parent
|
Non-controlling interests
|
Total
equity
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
At 1 Jan
2023
|
|
387
|
35,155
|
2,069
|
(574)
|
37,037
|
21
|
37,058
|
Profit for the period
|
|
-
|
-
|
-
|
3,621
|
3,621
|
3
|
3,624
|
Other comprehensive income
|
|
-
|
-
|
-
|
31
|
31
|
-
|
31
|
Transfer to other reserves
|
|
-
|
-
|
7
|
(7)
|
-
|
-
|
-
|
Transactions
with owners
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
-
|
-
|
(3,047)
|
(3,047)
|
-
|
(3,047)
|
Issue of Ordinary Shares
|
|
-
|
8
|
-
|
-
|
8
|
-
|
8
|
Share-based payments charge for the
period
|
|
-
|
-
|
-
|
274
|
274
|
-
|
274
|
Settlement of share plan awards
|
|
-
|
-
|
-
|
(532)
|
(532)
|
-
|
(532)
|
Net movement
|
|
-
|
8
|
7
|
340
|
355
|
3
|
358
|
At 30 Jun
2023
|
|
387
|
35,163
|
2,076
|
(234)
|
37,392
|
24
|
37,416
|
|
|
|
|
|
|
|
|
|
At 1 Jan
2024
|
|
388
|
35,188
|
2,065
|
1,502
|
39,143
|
23
|
39,166
|
Profit for the period
|
|
-
|
-
|
-
|
4,106
|
4,106
|
2
|
4,108
|
Other comprehensive expense
|
|
-
|
-
|
-
|
(414)
|
(414)
|
-
|
(414)
|
Transfer to other reserves
|
|
-
|
-
|
13
|
(13)
|
-
|
-
|
-
|
Transactions
with owners
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
-
|
-
|
(3,052)
|
(3,052)
|
-
|
(3,052)
|
Issue of Ordinary Shares
|
|
-
|
11
|
-
|
-
|
11
|
-
|
11
|
Changes in non-controlling interests
|
|
-
|
-
|
-
|
-
|
-
|
61
|
61
|
Share-based payments charge for the
period
|
|
-
|
-
|
-
|
307
|
307
|
-
|
307
|
Settlement of share plan
awards
|
|
-
|
-
|
-
|
(589)
|
(589)
|
-
|
(589)
|
Net movement
|
|
-
|
11
|
13
|
345
|
369
|
63
|
432
|
At 30 Jun
2024
|
|
388
|
35,199
|
2,078
|
1,847
|
39,512
|
86
|
39,598
|
Table 22: Condensed consolidated statement
of cash flows: H1 2024
For the half year ended 30
June
|
|
2024
|
2023
|
|
$m
|
$m
|
Cash flows from operating activities
|
|
|
|
Profit before tax
|
|
5,197
|
4,350
|
Finance income and expense
|
|
645
|
654
|
Share of after tax losses of associates and
joint ventures
|
|
19
|
1
|
Depreciation, amortisation and
impairment
|
|
2,534
|
2,778
|
Movement in working capital and short-term
provisions
|
|
(584)
|
(747)
|
Gains on disposal of intangible
assets
|
|
(21)
|
(249)
|
Fair value movements on contingent
consideration arising from business combinations
|
|
251
|
202
|
Non-cash and other movements
|
|
(550)
|
(594)
|
Cash generated
from operations
|
|
7,491
|
6,395
|
Interest paid
|
|
(583)
|
(483)
|
Tax paid
|
|
(1,337)
|
(1,061)
|
Net cash
inflow from operating activities
|
|
5,571
|
4,851
|
Cash flows from investing activities
|
|
|
|
Acquisition of subsidiaries, net of cash
acquired
|
|
(2,771)
|
(189)
|
Payments upon vesting of employee share awards
attributable to business combinations
|
|
-
|
(23)
|
Payment of contingent consideration from
business combinations
|
|
(474)
|
(398)
|
Purchase of property, plant and
equipment
|
|
(799)
|
(517)
|
Disposal of property, plant and
equipment
|
|
53
|
126
|
Purchase of intangible assets
|
|
(1,474)
|
(1,436)
|
Disposal of intangible assets
|
|
75
|
288
|
Movement in profit-participation
liability
|
|
-
|
175
|
Purchase of non-current asset
investments
|
|
(67)
|
(26)
|
Disposal of non-current asset
investments
|
|
51
|
10
|
Movement in short-term investments, fixed
deposits and other investing instruments
|
|
42
|
90
|
Payments to associates and joint
ventures
|
|
(140)
|
-
|
Disposal of investments in associates and joint
ventures
|
|
13
|
-
|
Interest received
|
|
206
|
134
|
Net cash
outflow from investing activities
|
|
(5,285)
|
(1,766)
|
Net cash
inflow before financing activities
|
|
286
|
3,085
|
Cash flows from financing activities
|
|
|
|
Proceeds from issue of share capital
|
|
11
|
8
|
Issue of loans and borrowings
|
|
4,976
|
3,816
|
Repayment of loans and borrowings
|
|
(2,643)
|
(3,408)
|
Dividends paid
|
|
(3,050)
|
(3,069)
|
Hedge contracts relating to dividend
payments
|
|
(8)
|
27
|
Repayment of obligations under
leases
|
|
(150)
|
(129)
|
Movement in short-term borrowings
|
|
2,503
|
72
|
Payment of Acerta Pharma share purchase
liability
|
|
(833)
|
(867)
|
Net cash
inflow/(outflow) from financing activities
|
|
806
|
(3,550)
|
Net increase/(decrease) in Cash and cash
equivalents in the period
|
|
1,092
|
(465)
|
Cash and cash equivalents at the beginning of
the period
|
|
5,637
|
5,983
|
Exchange rate effects
|
|
(52)
|
(47)
|
Cash and cash
equivalents at the end of the period
|
|
6,677
|
5,471
|
Cash and cash
equivalents consist of:
|
|
|
|
Cash and cash equivalents
|
|
6,916
|
5,664
|
Overdrafts
|
|
(239)
|
(193)
|
|
|
6,677
|
5,471
|
Responsibility statement of the directors in respect of
the half-yearly financial report
We confirm that to the best of our
knowledge:
‒
the condensed consolidated Interim Financial Statements have
been prepared in accordance with IAS 34
'Interim Financial Reporting' as issued by the
International Accounting Standards Board (IASB), IAS 34 as adopted
by the European Union and UK-adopted IAS 34;
‒
the half-yearly management report gives a true and fair view
of the assets, liabilities, financial position and profit or loss
of the company;
‒
the half-yearly management report includes a fair review of
the information required by:
a) DTR 4.2.7R of the Disclosure and
Transparency Rules, being an indication of important events that
have occurred during the first six months of the financial year and
their impact on the condensed consolidated Interim Financial
Statements; and a description of the principal risks and
uncertainties for the remaining six months of the year;
and
b) DTR 4.2.8R of the Disclosure and
Transparency Rules, being related party transactions that have
taken place in the first six months of the current financial year
and that have materially affected the financial position or
performance of the enterprise during that period; and any changes
in the related party transactions described in the last annual
report that could do so.
The Board
The Board of Directors that served during all
or part of the six month period to 30 June
2024 and their respective responsibilities can be found on
the Leadership
team section of astrazeneca.com.
Approved by the Board and signed on its behalf
by
Pascal Soriot
Chief Executive Officer
25 July 2024
Independent review report to AstraZeneca PLC
Report on the Interim financial statements
Our conclusion
We have reviewed AstraZeneca PLC's Interim
financial statements (the "Interim financial statements") in the
half-yearly financial report of AstraZeneca PLC for the six month
period ended 30 June 2024 (the "period").
Based on our review, nothing has come to our
attention that causes us to believe that the Interim financial
statements are not prepared, in all material respects, in
accordance with International Accounting Standard 34, 'Interim
Financial Reporting' (IAS 34), as issued by the International
Accounting Standards Board (IASB), IAS 34 as adopted by the
European Union, UK-adopted IAS 34, and the Disclosure Guidance and
Transparency Rules sourcebook of the United Kingdom's Financial
Conduct Authority.
The Interim financial statements
comprise:
‒
the Condensed consolidated statement of financial position as
at 30 June 2024;
‒ the Condensed consolidated
statement of comprehensive income: H1 2024 for the period then
ended;
‒
the Condensed consolidated statement of changes in equity for
the period then ended;
‒
the Condensed consolidated statement of cash flows: H1 2024
for the period then ended; and
‒
the explanatory notes to the Interim financial
statements.
The Interim financial statements included in
the half-yearly financial report of AstraZeneca PLC have been
prepared in accordance with International Accounting Standard 34,
'Interim Financial Reporting' (IAS 34), as issued by the
International Accounting Standards Board (IASB), IAS 34 as adopted
by the European Union, UK-adopted IAS 34, and the Disclosure
Guidance and Transparency Rules sourcebook of the United Kingdom's
Financial Conduct Authority.
Basis for conclusion
We conducted our review in accordance with
International Standard on Review Engagements (UK) 2410, 'Review of
Interim Financial Information Performed by the Independent Auditor
of the Entity' issued by the Financial Reporting Council for use in
the United Kingdom ("ISRE (UK)
2410"). A review of interim financial information
consists of making enquiries, 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.
We have read the other information contained in
the half-yearly financial report and considered whether it contains
any apparent misstatements or material inconsistencies with the
information in the Interim financial statements.
Conclusions 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 group to cease
to continue as a going concern.
Independent review report to
AstraZeneca PLC (continued)
Responsibilities for the Interim financial statements and
the review
Our responsibilities and those of
the directors
The half-yearly financial report, including the
Interim financial statements, is the responsibility of, and has
been approved by the directors. The directors are responsible for
preparing the half-yearly financial report in accordance with the
Disclosure Guidance and Transparency Rules sourcebook of the United
Kingdom's Financial Conduct Authority. In preparing the half-yearly
financial report, including the Interim financial statements, the
directors are responsible for assessing the group'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
group or to cease operations, or have no realistic alternative but
to do so.
Our responsibility is to express a conclusion
on the Interim financial statements in the half-yearly financial
report based on our review. Our conclusion, including our
Conclusions relating to going concern, is based on procedures that
are less extensive than audit procedures, as described in the Basis
for conclusion paragraph of this report. This report, including the
conclusion, has been prepared for and only for the company for the
purpose of complying with the Disclosure Guidance and Transparency
Rules sourcebook of the United Kingdom's Financial Conduct
Authority and for no other purpose. We do not, in giving this
conclusion, accept or assume responsibility for any other purpose
or to any other person to whom this report is shown or into whose
hands it may come save where expressly agreed by our prior consent
in writing.
PricewaterhouseCoopers LLP
Chartered Accountants
London
25 July 2024
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting
policies
These unaudited condensed consolidated Interim
financial statements for the six months ended 30 June 2024 have
been prepared in accordance with International Accounting Standard
34, 'Interim Financial Reporting' (IAS 34), as issued by the
International Accounting Standards Board (IASB), IAS 34 as adopted
by the European Union, UK-adopted IAS 34 and the Disclosure
Guidance and Transparency Rules sourcebook of the United Kingdom's
Financial Conduct Authority and with the requirements of the
Companies Act 2006 as applicable to companies reporting under those
standards.
The unaudited Interim financial statements for
the six months ended 30 June 2024 were approved by the Board of
Directors for publication on 25 July 2024.
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 annual financial
statements of the Group for the year ended 31 December 2023 were
prepared in accordance with UK-adopted international accounting
standards and with the requirements of the Companies Act 2006. The
annual financial statements also comply fully with IFRS Accounting
Standards as issued by the IASB and International Accounting
Standards as adopted by the European Union. Except for the
estimation of the interim income tax charge, the Interim financial
statements have been prepared applying the accounting policies that
were applied in the preparation of the Group's published
consolidated financial statements for the year ended 31 December
2023.
The comparative figures for the financial year
ended 31 December 2023 are not the Group's statutory accounts for
that financial year. Those accounts have been reported on by the
Group's auditors and have been delivered to the Registrar of
Companies; their report was (i) unqualified, (ii) did not include a
reference to any matters to which the auditors drew attention by
way of emphasis without qualifying their report, and (iii) did not
contain a statement under section 498(2) or (3) of the Companies
Act 2006.
Going concern
The Group has considerable financial resources
available. As at 30 June 2024, the Group has $11.8bn in financial
resources (cash and cash equivalent balances of $6.9bn and undrawn
committed bank facilities of $4.9bn, with $5.4bn of borrowings due
within one year). These facilities contain no financial covenants
and were undrawn at 30 June 2024. The $4.9bn facilities are
available until April 2029. Additionally, there are a further
$2.0bn undrawn committed bank facilities available until February
2025.
The Group's revenues are largely derived from
sales of medicines covered by patents, which provide a relatively
high level of resilience and predictability to cash inflows,
although government price interventions in response to budgetary
constraints are expected to continue to adversely affect revenues
in some of our significant markets. The Group, however, anticipates
new revenue streams from both recently launched medicines and those
in development, and the Group has a wide diversity of customers and
suppliers across different geographic areas.
Consequently, the Directors believe that,
overall, the Group is well placed to manage its business risks
successfully. Accordingly, they continue to adopt the going concern
basis in preparing the Interim financial statements.
Legal proceedings
The information contained in Note 6 updates the
disclosures concerning legal proceedings and contingent liabilities
in the Group's
Annual Report and Form 20-F Information 2023.
Employee Benefit Trust
Following an amendment to the Employee Benefit
Trust (EBT) Deed on 10th June 2024, AstraZeneca obtained control
and commenced consolidation of the EBT. Going forward, cash paid on
purchases of AstraZeneca Ordinary shares or American Depository
Receipts will be presented within Financing activities in the Cash
flow statement.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of
Assets', reviews for triggers of impairment or impairment reversals
at an individual asset or cash generating unit level were
conducted, and impairment tests carried out where triggers were
identified. As a result, total impairment charge of $26m has been
recorded against intangible assets during the six months ended 30
June 2024 (H1 2023: $320m net charge). In H1 2023, net impairment
charges included the $244m impairment of the ALXN1840 intangible
asset, following the decision to discontinue this development
programme in Wilson's disease.
The acquisition of Icosavax, Inc. completed on
19 February 2024. The transaction is recorded as an asset
acquisition based on the concentration test permitted under IFRS 3
'Business Combinations', with consideration of $841m principally
relating to $639m of intangible assets, $141m of cash and cash
equivalents and $51m of marketable securities. Contingent
consideration of up to $300m could be paid on achievement of
regulatory and sales milestones; these potential liabilities would
be recorded when the relevant recognition event for a regulatory or
sales milestone is achieved.
Note 3: Net debt
The table below provides an analysis of Net debt and a reconciliation of Net Cash flow to
the movement in Net debt. The Group monitors Net debt as part of
its capital management policy as described in Note 28 of the
Annual Report and Form 20-F Information
2023. Net debt is a non-GAAP
financial measure.
Table 23: Net debt
|
|
At 1 Jan 2024
|
Cash flow
|
Acquisitions
|
Non-cash
&
other
|
Exchange movements
|
At 30 Jun 2024
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Non-current instalments of loans
|
|
(22,365)
|
(4,973)
|
(3)
|
(2)
|
118
|
(27,225)
|
Non-current instalments of leases
|
|
(857)
|
-
|
(12)
|
(97)
|
17
|
(949)
|
Total
long-term debt
|
|
(23,222)
|
(4,973)
|
(15)
|
(99)
|
135
|
(28,174)
|
Current instalments of loans
|
|
(4,614)
|
2,583
|
(9)
|
(5)
|
27
|
(2,018)
|
Current instalments of leases
|
|
(271)
|
174
|
(6)
|
(197)
|
8
|
(292)
|
Commercial paper
|
|
-
|
(2,453)
|
-
|
-
|
-
|
(2,453)
|
Collateral received from derivative
counterparties
|
|
(215)
|
13
|
-
|
-
|
-
|
(202)
|
Other short-term borrowings excluding
overdrafts
|
|
(97)
|
(63)
|
-
|
-
|
5
|
(155)
|
Overdrafts
|
|
(203)
|
(35)
|
-
|
-
|
(1)
|
(239)
|
Total current
debt
|
|
(5,400)
|
219
|
(15)
|
(202)
|
39
|
(5,359)
|
Gross
borrowings
|
|
(28,622)
|
(4,754)
|
(30)
|
(301)
|
174
|
(33,533)
|
Net derivative financial instruments
|
|
150
|
65
|
-
|
(82)
|
-
|
133
|
Net
borrowings
|
|
(28,472)
|
(4,689)
|
(30)
|
(383)
|
174
|
(33,400)
|
Cash and cash equivalents
|
|
5,840
|
885
|
242
|
-
|
(51)
|
6,916
|
Other investments - current
|
|
122
|
(42)
|
87
|
-
|
(7)
|
160
|
Cash and
investments
|
|
5,962
|
843
|
329
|
-
|
(58)
|
7,076
|
Net
debt
|
|
(22,510)
|
(3,846)
|
299
|
(383)
|
116
|
(26,324)
|
Net debt increased by $3,814m in the half year
to $26,324m. Details of the committed undrawn bank facilities are
disclosed within the going concern section of Note 1. Non-cash
movements in the period include fair value adjustments under IFRS 9
'Financial Instruments'.
In February 2024, AstraZeneca issued the
following:
- $1,250m
of fixed-rate notes with a coupon of 4.8% maturing in February
2027
- $1,250m
of fixed-rate notes with a coupon of 4.85% maturing in February
2029
- $1,000m
of fixed-rate notes with a coupon of 4.9% maturing in February
2031
- $1,500m
of fixed-rate notes with a coupon of 5% maturing in February
2034
AstraZeneca repaid two bonds of carrying value
$2,569m in Q2 2024 included in the cash outflow from Repayment of
loans and borrowings of $2,643m. AstraZeneca also issued Commercial
paper during the half year and the balance as at 30 June 2024 is
$2,453m (H1 2023: $nil).
The Group has agreements with some bank
counterparties whereby the parties agree to post cash collateral on
financial derivatives, for the benefit of the other, equivalent to
the market valuation of the derivative positions above a
predetermined threshold. The carrying value of such cash collateral
held by the Group at 30 June 2024 was $202m (31 December 2023:
$215m) and the carrying value of such cash collateral posted by the
Group at 30 June 2024 was $97m (31 December 2023:
$102m).
The equivalent GAAP measure to Net debt is
'liabilities arising from financing activities', which excludes the
amounts for cash and overdrafts, other investments and
non-financing derivatives shown above and includes the Acerta
Pharma share purchase liability of $nil (31 December 2023:
$833m).
During the six months ended 30 June 2024, there
have been no changes to the Company's solicited long term credit
ratings. Moody's credit ratings were long term: A2; short term:
P-1. Standard and Poor's credit ratings were long term: A; short
term: A-1.
Note 4: Financial Instruments
As detailed in the Group's most recent annual
financial statements, the principal financial instruments consist
of derivative financial instruments, other investments, trade and
other receivables, cash and cash equivalents, trade and other
payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that
are categorised as Level 3 in the fair value hierarchy that are
held at $337m (31 December 2023: $313m) and for which a fair value
gain of $1m has been recognised in the six months ended 30 June
2024 (H1 2023: $1m). In the absence of specific market data, these
unlisted investments are held at fair value based on the cost of
investment and adjusted as necessary for impairments and
revaluations on new funding rounds, which are seen to approximate
the fair value. All other fair value gains and/or losses that are
presented in Net gains/(losses) on equity investments measured at
fair value through other comprehensive income, in the Condensed
consolidated statement of comprehensive income for the six months
ended 30 June 2024, are Level 1 fair value measurements, valued
based on quoted prices in active markets.
Financial instruments measured at fair value
include $1,670m of other investments, $5,463m held in money-market
funds and $133m of derivatives as at 30 June 2024. With the
exception of derivatives being Level 2 fair valued, and certain
equity instruments of $350m categorised as Level 3, the
aforementioned balances are Level 1 fair valued. Financial
instruments measured at amortised cost include $97m of cash
collateral pledged to counterparties. The total fair value of
interest-bearing loans and borrowings at 30 June 2024, which have a
carrying value of $33,533m in the Condensed consolidated statement
of financial position, was $32,231m.
Table 24: Financial instruments -
contingent consideration
|
|
Diabetes alliance
|
Other
|
Total
|
Total
|
|
|
$m
|
$m
|
$m
|
$m
|
At 1
January
|
|
1,945
|
192
|
2,137
|
2,222
|
Additions through business
combinations
|
|
-
|
198
|
198
|
60
|
Settlements
|
|
(473)
|
(1)
|
(474)
|
(398)
|
Revaluations
|
|
220
|
31
|
251
|
202
|
Discount unwind
|
|
50
|
7
|
57
|
66
|
At 30
June
|
|
1,742
|
427
|
2,169
|
2,152
|
Contingent consideration arising from business
combinations is fair valued using decision-tree analysis, with key
inputs including the probability of success, consideration of
potential delays and the expected levels of future
revenues.
The contingent consideration balance relating
to BMS's share of the global diabetes alliance of $1,742m
(31 December 2023: $1,945m) would increase/decrease by $174m
with an increase/decrease in sales of 10%, as compared with the
current estimates.
Note 5: Business combinations
Gracell
On 22 February 2024, AstraZeneca completed the
acquisition of Gracell Biotechnologies Inc. (Gracell), a global
clinical-stage biopharmaceutical company developing innovative cell
therapies for the treatment of cancer and autoimmune diseases.
Gracell will operate as a wholly owned subsidiary of AstraZeneca,
with operations in China and the US.
The acquisition enriches AstraZeneca's growing
pipeline of cell therapies with AZD0120 (formerly GC012F), a novel,
clinical-stage T-cell (CAR-T: therapeutic chimeric antigen
receptor) therapy. AZD0120 is a potential new treatment for
multiple myeloma, as well as other haematologic malignancies and
autoimmune diseases, including Systemic Lupus Erythematosus
(SLE).
The transaction is recorded as a business
combination using the acquisition method of accounting in
accordance with IFRS 3 'Business Combinations'. Consequently, the
assets acquired, and liabilities assumed are recorded at fair
value. Due to the proximity of the acquisition to the reporting
date, the purchase price allocation exercise under IFRS 3 is in
process, with the following items disclosed on a provisional
basis.
|
|
Fair values
|
|
|
$m
|
Intangible assets
|
|
1,038
|
Cash and cash equivalents
|
|
212
|
Net deferred tax liability
|
|
(260)
|
Other immaterial balances
|
|
(89)
|
Total net
assets acquired
|
|
901
|
Goodwill
|
|
136
|
Consideration
|
|
1,037
|
The total consideration fair value of $1,037m
includes cash consideration of $983m and future regulatory
milestone-based consideration of $54m. Intangible assets recognised
relate to products in development, principally AZD0120, and were
fair valued using the multi-period excess earnings method, which
uses several estimates regarding the amount and timing of future
cash flows. The key assumptions in the cash flows are PTRS, peak
year sales and revenue erosion profiles.
The net deferred tax liability of $260m
principally arises from the deferred tax impact of the uplift in
fair value of intangible assets.
Goodwill of $136m has been recognised, which
principally comprises the premium attributable to the core
technological capabilities and knowledge base of the company.
Goodwill is not expected to be deductible for tax
purposes.
Gracell's results have been consolidated into
the Group's results from 22 February 2024.
Fusion
On 4 June 2024, AstraZeneca completed the
acquisition of Fusion Pharmaceuticals Inc., (Fusion) a
clinical-stage biopharmaceutical company developing next-generation
radioconjugates. The acquisition marks a major step forward in
AstraZeneca delivering on its ambition to transform cancer
treatment and outcomes for patients by replacing traditional
regimens like chemotherapy and radiotherapy with more targeted
treatments. As a result of the acquisition, Fusion became a wholly
owned subsidiary of AstraZeneca, with operations in Canada and the
US.
This acquisition complements AstraZeneca's
leading oncology portfolio with the addition of the Fusion pipeline
of radioconjugates, including their most advanced programme,
FPI-2265, a potential new treatment for patients with metastatic
castration-resistant prostate cancer (mCRPC), and brings new
expertise and pioneering R&D, manufacturing and supply chain
capabilities in actinium-based radioconjugates to
AstraZeneca.
The transaction is recorded as a business
combination using the acquisition method of accounting in
accordance with IFRS 3 'Business Combinations'. Consequently, the
assets acquired, and liabilities assumed are recorded at fair
value. Due to the proximity of the acquisition to the reporting
date, the purchase price allocation exercise under IFRS 3 is in
process, with the following items disclosed on a provisional
basis.
|
|
Fair values
|
|
|
$m
|
Intangible assets
|
|
1,326
|
Cash and cash equivalents
|
|
30
|
Current investments
|
|
87
|
Net deferred tax liability
|
|
(246)
|
Other immaterial balances
|
|
51
|
Total net
assets acquired
|
|
1,248
|
Goodwill
|
|
947
|
Consideration
|
|
2,195
|
The total consideration fair value of $2,195m
includes cash consideration of $2,051m and future regulatory
milestone-based consideration of $144m. Intangible assets relating
to products in development comprise the FPI-2265 ($848m), FPI-2059
($165m) and AZD2068 ($313m) programmes. These were fair valued
using the multi-period excess earnings method, which uses several
estimates regarding the amount and timing of future cash flows. The
key assumptions in the cash flows are PTRS, peak year sales and
revenue erosion profiles.
The net deferred tax liability of $246m
principally arises from the deferred tax impact of the uplift in
fair value of intangible assets.
Goodwill recognised comprises a number of not
individually quantifiable elements. These include the premium
attributable to a pre-existing well positioned business in the
innovation intensive biopharmaceuticals market with a highly
skilled workforce, unidentified potential products that future
research and development may yield, and the core capabilities and
knowledge base of the company including radioisotope supply and
manufacturing expertise. Goodwill is not expected to be deductible
for tax purposes.
Immediately prior to the acquisition,
AstraZeneca held an approximately 1% shareholding in Fusion
considered to have a fair value of $24m.
Fusion's results have been consolidated into
the Group's results from 4 June 2024.
Note 6: Legal proceedings and contingent
liabilities
AstraZeneca is involved in various legal
proceedings considered typical to its business, including
litigation and investigations, including Government investigations,
relating to product liability, commercial disputes, infringement of
intellectual property (IP) rights, the validity of certain patents,
anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since
publication of the disclosures concerning legal proceedings in the
Company's Annual Report and Form 20-F Information 2023 (the
Disclosures). Information about the nature and facts of the cases
is disclosed in accordance with IAS 37.
As discussed in the Disclosures, the majority
of claims involve highly complex issues. Often these issues are
subject to substantial uncertainties and, therefore, the
probability of a loss, if any, being sustained and/or an estimate
of the amount of any loss is difficult to ascertain.
In cases that have been settled or adjudicated,
or where quantifiable fines and penalties have been assessed and
which are not subject to appeal, or where a loss is probable and we
are able to make a reasonable estimate of the loss, AstraZeneca
records the loss absorbed or makes a provision for its best
estimate of the expected loss. The position could change over time
and the estimates that the Company made, and upon which the Company
have relied in calculating these provisions are inherently
imprecise. There can, therefore, be no assurance that any losses
that result from the outcome of any legal proceedings will not
exceed the amount of the provisions that have been booked in the
accounts. The major factors causing this uncertainty are described
more fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will
vigorously defend and enforce, its IP.
Matters disclosed in respect of the second
quarter of 2024 and to 25 July 2024
Patent litigation
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
Enhertu
US patent proceedings
In October 2020, Seagen Inc. (Seagen) filed a
complaint against Daiichi Sankyo Company, Limited (Daiichi Sankyo)
in the US District Court for the Eastern District of Texas
(District Court) alleging that Enhertu infringes a Seagen patent.
AstraZeneca co-commercialises Enhertu with Daiichi Sankyo, Inc. in
the US. After trial in April 2022, the jury found that the patent
was infringed and awarded Seagen $41.82m in past damages. In July
2022, the District Court entered final judgment and declined to
enhance damages on the basis of wilfulness. In October 2023, the
District Court entered an amended final judgment that requires
Daiichi Sankyo to pay Seagen a royalty of 8% on US sales of
Enhertu from 1 April 2022
through to 4 November 2024, in addition to the past damages
previously awarded by the District Court. AstraZeneca and Daiichi
Sankyo have appealed the District Court's decision.
In December 2020 and January 2021, AstraZeneca
and Daiichi Sankyo, Inc. filed post-grant review (PGR) petitions
with the US Patent and Trademark Office (USPTO) alleging, among
other things, that the Seagen patent is invalid for lack of written
description and enablement. The USPTO initially declined to
institute the PGRs, but, in April 2022, the USPTO granted the
rehearing requests and instituted both PGR petitions. Seagen
subsequently disclaimed all patent claims at issue in one of the
PGR proceedings. In July 2022, the USPTO reversed its institution
decision and declined to institute the other PGR petition.
AstraZeneca and Daiichi Sankyo, Inc. requested reconsideration of
the decision not to institute review of the patent. In February
2023, the USPTO reinstituted the PGR proceeding. In February 2024,
the USPTO issued a decision that the claims were unpatentable.
Seagen has appealed this decision.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc.
(Puma) and Wyeth LLC (Wyeth) filed a patent infringement lawsuit in
the US District Court for the District of Delaware (District Court)
against AstraZeneca relating to Tagrisso. In March 2024, the District
Court dismissed Puma. The trial, with Wyeth as the plaintiff, took
place in May 2024. The jury found Wyeth's patents infringed and
awarded Wyeth $107.5m in past damages. The jury also found that the
infringement was not wilful. A bench trial on AstraZeneca's
indefiniteness and equitable defenses took place in June 2024. The
parties await the court's decision on the bench trial issues and
consideration of post-trial motions.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV
notices from multiple ANDA filers, AstraZeneca filed patent
infringement lawsuits in the US District Court for the District of
Delaware (District Court). In its complaint, AstraZeneca alleged
that a generic version of Calquence capsules, if approved and
marketed, would infringe patents that are owned or licensed by
AstraZeneca. In 2024, AstraZeneca entered into settlement
agreements with all five generic manufacturers, resolving the
Calquence capsule ANDA
litigation proceedings.
In April 2024, AstraZeneca received a Paragraph
IV notice from an ANDA filer relating to patents listed in the FDA
Orange Book with reference to Calquence tablets. In May 2024, in
response to the Paragraph IV notice, AstraZeneca filed a patent
infringement lawsuit against Cipla Limited and Cipla USA, Inc. in
the District Court, alleging that a generic version of Calquence tablets, if approved and
marketed, would infringe patents that are owned or licensed by
AstraZeneca.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV
notices, AstraZeneca initiated ANDA litigation against multiple
generic filers in the US District Court for the District of
Delaware (District Court). AstraZeneca alleged that a generic
version of Lokelma, if
approved and marketed, would infringe patents that are owned or
licensed by AstraZeneca.
AstraZeneca entered into separate settlement
agreements with two generic manufacturers which resulted in
dismissal of the corresponding litigations. Additional proceedings
with the remaining generic manufacturers are ongoing in the
District Court. Trial is scheduled for March 2025.
Lynparza
US patent proceedings
In December 2022, AstraZeneca received a
Paragraph IV notice from Natco Pharma Limited (Natco) relating to
Lynparza patents. In
February 2023, in response to the Paragraph IV notice, AstraZeneca,
MSD International Business GmbH, and the University of Sheffield
initiated ANDA litigation against Natco in the US District Court
for the District of New Jersey (District Court). In the complaint,
AstraZeneca alleged that Natco's generic version of Lynparza, if approved and marketed,
would infringe AstraZeneca's patents. No trial date has been
scheduled.
In December 2023, AstraZeneca received a
Paragraph IV notice from Sandoz Inc. (Sandoz) relating to
Lynparza patents. In
February 2024, in response to the Paragraph IV notice, AstraZeneca,
MSD International Business GmbH, and the University of Sheffield
initiated ANDA litigation against Sandoz in the District Court. In
the complaint, AstraZeneca alleged that Sandoz's generic version of
Lynparza, if approved and
marketed, would infringe AstraZeneca's patents. No trial date has
been scheduled.
In May 2024, AstraZeneca filed additional ANDA
actions against Natco and Sandoz asserting recently issued patents
covering Lynparza. These
actions have been consolidated with the earlier filed ANDA actions
and no trial date has been scheduled.
In May 2024, AstraZeneca received a Paragraph
IV notice from Cipla USA, Inc. and Cipla Limited (collectively,
Cipla) relating to Lynparza patents. In June 2024, in
response to the Paragraph IV notice, AstraZeneca, MSD International
Business GmbH, and the University of Sheffield initiated ANDA
litigation against Cipla in the District Court. In the complaint,
AstraZeneca alleged that Cipla's generic version of Lynparza, if approved and marketed,
would infringe AstraZeneca's patents. No trial date has been
scheduled.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent
infringement litigation against Samsung Bioepis Co. Ltd. (Samsung)
in the US District Court for the District of Delaware alleging that
Samsung's biosimilar eculizumab product will infringe six
Soliris-related patents.
No trial date has been scheduled. Five of the six asserted patents
are also the subject of inter partes review (IPR) proceedings
before the US Patent and Trademark Office. Alexion filed a motion
for a preliminary injunction seeking to enjoin Samsung from
launching its biosimilar eculizumab product upon FDA approval. The
court denied Alexion's motion and Alexion has appealed that
decision. On 22 July 2024, Samsung announced FDA approval of
Samsung's biosimilar.
European patent proceedings
In March 2024, Alexion filed motions for
provisional measures against Amgen Pharmaceuticals Inc (Amgen) and
Samsung Bioepis Co. Ltd. (Samsung) and their respective affiliates
at the Hamburg Local Division of the Unified Patent Court on the
basis that Amgen's and Samsung's biosimilar eculizumab products
infringe an Alexion patent. In June 2024 the UPC denied the
requested provisional measures. Alexion has appealed this decision.
In parallel, Samsung has filed opposition to the patent at the
European Patent Office.
UK patent proceedings
In May 2024, Alexion initiated patent
infringement proceedings against Amgen Ltd and Samsung Bioepis UK
Ltd (Samsung UK) in the UK High Court of Justice alleging that
their respective biosimilar eculizumab products infringe an Alexion
patent; on the same day, Samsung UK initiated a revocation action
for the same patent. Trial has been scheduled for March
2025.
Tagrisso
Russia patent proceedings
In Russia, in August 2023, AstraZeneca filed
lawsuits in the Arbitration Court of the Moscow Region (Court)
against the Ministry of Health of the Russian Federation and
Axelpharm LLC (Axelpharm) related to Axelpharm's improper use of
AstraZeneca's information to obtain authorisation to market a
generic version of Tagrisso. In December 2023, the Court
dismissed the lawsuit against the Ministry of Health of the Russian
Federation. The appellate court affirmed the dismissal in March
2024. AstraZeneca filed a further appeal, which remains pending.
The lawsuit against Axelpharm remains pending.
In Russia, in November 2023, Axelpharm filed a
compulsory licensing action against AstraZeneca in the Court
related to a patent that covers Tagrisso. The compulsory licensing
action remains pending. AstraZeneca has also challenged before the
Russian Patent and Trademark Office ("PTO") the validity of the
Axelpharm patent on which the compulsory licensing action is
predicated; that challenge remains pending before the Russian
PTO.
In July 2024, AstraZeneca filed a patent
infringement lawsuit and an unfair competition claim with the
Federal Anti-Monopoly Service of Russia against AxelPharm and
others related to the securing of state contracts in Russia for its
generic version of osimertinib.
Commercial litigation
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
Anti-Terrorism Act Civil Lawsuit
US proceedings
In the US, in October 2017, AstraZeneca and
certain other pharmaceutical and/or medical device companies were
named as defendants in a complaint filed in the US District Court
for the District of Columbia (District Court) by US nationals (or
their estates, survivors, or heirs) who were killed or wounded in
Iraq between 2005 and 2013. The plaintiffs allege that the
defendants violated the US Anti-Terrorism Act and various state
laws by selling pharmaceuticals and medical supplies to the Iraqi
Ministry of Health. In July 2020, the District Court granted
AstraZeneca's and the other defendants' motion to dismiss the
lawsuit, which the DC Circuit Court of Appeals (the Appellate
Court) reversed in January 2022. In June 2024, the United States
Supreme Court issued an order vacating the 2022 decision and
granted AstraZeneca's and the other defendants' request for a
remand to the Appellate Court for reconsideration under new case
law.
Employment Litigation
US proceedings
In December 2022, AstraZeneca was served with a
lawsuit filed by seven former employees in the US District Court
for the District of Delaware (District Court) asserting claims of
discrimination on grounds of age and religion, related to
AstraZeneca's vaccination requirement. In March 2023, AstraZeneca
filed a partial motion to dismiss certain religious discrimination
claims and a motion to strike the class and collective claims. In
September 2023, Plaintiffs moved for conditional certification of
the collective action. In June 2024, the District Court granted
AstraZeneca's partial motion to dismiss, granted AstraZeneca's
motion to strike, and denied without prejudice Plaintiff's motion
for conditional certification.
Pay Equity Litigation
US proceedings
AstraZeneca is defending a putative class and
collective action in the US District Court for the Northern
District of Illinois (District Court) brought by three named
plaintiffs, who are former AstraZeneca employees. The case involves
claims under the federal and Illinois Equal Pay Acts, with the
plaintiffs alleging they were paid less than male employees who
performed substantially similar and/or equal work. In May 2024, the
District Court conditionally certified a collective under the
federal Equal Pay Act and authorised the sending of notice to
potential collective action members. The notice was distributed in
June 2024.
University of Sheffield Contract Dispute
UK proceedings
In June 2024, AstraZeneca was served with a
lawsuit filed by the University of Sheffield (Sheffield). In its
complaint, Sheffield alleges that AstraZeneca made
misrepresentations to induce Sheffield to amend a patent license
relating to Lynparza.
AstraZeneca is considering its response.
Viela Bio, Inc. Shareholder Litigation
US proceedings
In February 2023, AstraZeneca was served with a
lawsuit filed in Delaware state court against AstraZeneca and
certain officers (collectively, Defendants), on behalf of a
putative class of Viela Bio, Inc. (Viela) shareholders. The
complaint alleged that the Defendants breached their fiduciary duty
to Viela shareholders in the course of Viela's 2021 merger with
Horizon Therapeutics, plc. In July 2024, the Court granted with
prejudice AstraZeneca's motion to dismiss.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned
by GlaxoSmithKline plc, (GSK)) entered into two worldwide,
royalty-bearing patent license agreements with AstraZeneca related
to GSK's product niraparib. In May 2021, AstraZeneca filed a
lawsuit against GSK in the Commercial Court of England and Wales
alleging that GSK had failed to pay all of the royalties due on
niraparib sales under the license agreements. In April 2023, after
trial, the trial court issued a decision in AstraZeneca's favour.
In February 2024, the Court of Appeal reversed the decision. In
March 2024, AstraZeneca filed a request for permission to appeal
with the Supreme Court of the United Kingdom. In May 2024, the
Supreme Court denied permission to appeal. The case will return to
the trial court for further proceedings.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
Boston US Attorney Investigation
US Proceedings
In June 2024, AstraZeneca was served with a
subpoena issued by the US Attorney's Office in Boston, seeking
documents and information relating to payments by AstraZeneca to
healthcare providers. AstraZeneca is cooperating with this
enquiry.
Turkish Ministry of Health Matter
Turkey proceedings
In Turkey, in July 2020, the Turkish Ministry
of Health (Ministry of Health) initiated an investigation regarding
payments to healthcare providers by Alexion and former employees
and consultants. The investigation arose from Alexion's disclosure
of a $21.5m civil settlement with the US Securities & Exchange
Commission (SEC) in July 2020 fully resolving the SEC's
investigation into possible violations of the US Foreign Corrupt
Practices Act. In September 2021, the Ministry of Health completed
its draft investigation report, and referred the matter to the
Ankara Public Prosecutor's Office with a recommendation for further
proceedings against certain former employees. In June 2024, the
Ankara Public Prosecutor's Office closed its investigation without
further action.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in
the US District Court for the District of Delaware (District Court)
against the US Department of Health and Human Services (HHS)
challenging aspects of the drug price negotiation provisions of the
Inflation Reduction Act and the implementing guidance and
regulations. In March 2024, the District Court granted HHS' motions
and dismissed AstraZeneca's lawsuit. AstraZeneca has appealed the
District Court's decision.
340B State Litigation
US proceedings
AstraZeneca has filed lawsuits against
Arkansas, Kansas, Louisiana, Maryland, Minnesota, Mississippi, and
West Virginia challenging the constitutionality of each state's
340B statute. In the Arkansas matter, trial is scheduled for April
2025. In the Louisiana matter, AstraZeneca and the state have filed
motions for summary judgment and a hearing was held in June 2024.
The remaining matters are in their preliminary stages.
Other
Additional government inquiries
As is true for most, if not all, major
prescription pharmaceutical companies, AstraZeneca is currently
involved in multiple inquiries into drug marketing and pricing
practices. In addition to the investigations described above,
various law enforcement offices have, from time to time, requested
information from the Group. There have been no material
developments in those matters.
Matters disclosed in respect of the first
quarter of 2024 and to 25 April 2024
Patent litigation
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
Forxiga
UK patent proceedings
In the UK, one of AstraZeneca's patents
relating to Forxiga is
being challenged by Generics (UK) Limited, Teva Pharmaceutical
Industries Limited, and Glenmark Pharmaceuticals Europe Limited.
Trial is scheduled for March 2025.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc.
(Puma) and Wyeth LLC (Wyeth) filed a patent infringement lawsuit in
the US District Court for the District of Delaware (District Court)
against AstraZeneca relating to Tagrisso. In March 2024, the District
Court dismissed Puma. A trial, with Wyeth as the plaintiff, has
been scheduled for May 2024.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV
notices from multiple ANDA filers, AstraZeneca filed patent
infringement lawsuits in the US District Court for the District of
Delaware (District Court). In its complaint, AstraZeneca alleged
that a generic version of Calquence capsules, if approved and
marketed, would infringe patents that are owned or licensed by
AstraZeneca. Trial is scheduled for March 2025.
In March and April 2024, AstraZeneca entered
into settlement agreements with generic manufacturers, Sandoz Inc.,
and Natco Pharma Limited with Natco Pharma Inc., resulting in
dismissal of the corresponding Calquence capsule ANDA litigation
proceedings. Additional Calquence capsule ANDA litigation
proceedings with the remaining three generic manufacturers are
ongoing in the District Court.
In April 2024, AstraZeneca received a Paragraph
IV notice from an ANDA filer relating to patents listed in the FDA
Orange Book with reference to Calquence tablets. AstraZeneca is
considering its response.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV
notices, AstraZeneca initiated ANDA litigation against multiple
generic filers in the US District Court for the District of
Delaware (District Court). Trial is scheduled for March
2025.
AstraZeneca entered into a settlement agreement
with a generic manufacturer, Alkem Laboratories, which resulted in
dismissal of the corresponding litigation. Additional proceedings
with the remaining generic manufacturers are ongoing in the
District Court.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent
infringement litigation against Samsung Bioepis Co. Ltd. (Samsung)
in the US District Court for the District of Delaware alleging that
Samsung's biosimilar eculizumab product, for which Samsung is
currently seeking FDA approval, will infringe six Soliris-related patents. No trial date
has been scheduled. Five of the six asserted patents are also the
subject of inter partes review proceedings before the US Patent and
Trademark Office. In February 2024, Alexion filed a motion for a
preliminary injunction seeking to enjoin Samsung from launching its
biosimilar eculizumab product upon FDA approval. A hearing on
Alexion's preliminary injunction motion is scheduled for May
2024.
European patent proceedings
In March 2024, Alexion filed motions for
preliminary injunctions against Amgen and Samsung at the Hamburg
Local Division of the Unified Patent Court on the basis that
Amgen's and Samsung's biosimilar eculizumab products infringe
Alexion's eculizumab molecule patent that is expected to grant in
Q2 2024. No hearing date for the preliminary injunction motions has
been set.
Tagrisso
Russia patent proceedings
In Russia, in August 2023, AstraZeneca filed
lawsuits in the Arbitration Court of the Moscow Region (Court)
against the Ministry of Health of the Russian Federation and
Axelpharm LLC (Axelpharm) related to Axelpharm's improper use of
AstraZeneca's information to obtain authorisation to market a
generic version of Tagrisso. In December 2023, the Court
dismissed the lawsuit against the Ministry of Health of the Russian
Federation. In January 2024, AstraZeneca filed an appeal, and the
appellate court affirmed the dismissal in March 2024. The lawsuit
against Axelpharm remains pending.
In Russia, in November 2023, Axelpharm filed a
compulsory licensing action against AstraZeneca in the Court
related to a patent that covers Tagrisso. The compulsory licensing
action remains pending.
Product liability litigation
Legal proceedings brought against AstraZeneca for which a
provision has been taken
Nexium
and Losec/Prilosec
US proceedings
AstraZeneca has been defending lawsuits brought
in federal and state courts involving claims that plaintiffs have
been diagnosed with various injuries following treatment with
proton pump inhibitors (PPIs), including Nexium and Prilosec. Most of the lawsuits alleged
kidney injury. In August 2017, the pending federal court cases were
consolidated into a multidistrict litigation (MDL) proceeding in
the US District Court for the District of New Jersey for pre-trial
purposes. Cases alleging kidney injury were also filed in Delaware
and New Jersey state courts.
In addition, AstraZeneca has been defending
lawsuits involving allegations of gastric cancer following
treatment with PPIs, including one such claim in the US District
Court for the Middle District of Louisiana (Louisiana District
Court).
In October 2023, AstraZeneca resolved all
pending claims in the MDL, as well as all pending claims in
Delaware and New Jersey state courts, for $425m, for which a
provision has been taken. The only remaining case is the one
pending in the Louisiana District Court, which is scheduled for
trial in January 2025.
Canada proceedings
In Canada, in July and August 2017, AstraZeneca
was served with three putative class action lawsuits. Two of the
lawsuits have been dismissed, one in 2019 and one in 2021. The
third lawsuit seeks authorisation to represent individual residents
in Canada who allegedly suffered kidney injuries from the use of
proton pump inhibitors, including Nexium and Losec.
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
Onglyza
and Kombiglyze
US proceedings
In the US, AstraZeneca has been defending
various lawsuits in both California state court and in a
consolidated federal proceeding alleging heart failure, cardiac
injuries, and/or death from treatment with Onglyza or Kombiglyze. In the California state
court proceeding, the trial court granted summary judgment for
AstraZeneca, which the California appellate court affirmed. The
California Supreme Court has declined further review, and the
California matter has concluded. The consolidated federal cases
were dismissed in August 2022 by the US District Court for the
Eastern District of Kentucky. That dismissal was affirmed by the US
Court of Appeals for the Sixth Circuit in February 2024.
Vaxzevria
UK proceedings
AstraZeneca is defending lawsuits in the UK
involving multiple claimants alleging injuries following
vaccination with AstraZeneca's COVID-19 vaccine. Most of the
lawsuits involve claims of thrombosis with thrombocytopenia
syndrome. No trial dates have been scheduled.
Commercial litigation
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
340B Antitrust Litigation
US proceedings
In September 2021, AstraZeneca was served with
a class-action antitrust complaint filed in the US District Court
for the Western District of New York (District Court) by Mosaic
Health alleging a conspiracy to restrict access to 340B discounts
in the diabetes market through contract pharmacies. In September
2022, the District Court granted AstraZeneca's motion to dismiss
the Complaint. In February 2024, the District Court denied
Plaintiffs' request to file an amended complaint and entered an
order closing the matter. In March 2024, Plaintiffs filed an
appeal.
Definiens
Germany proceedings
In Germany, in July 2020, AstraZeneca received
a notice of arbitration filed with the German Institution of
Arbitration from the sellers of Definiens AG (the Sellers)
regarding the 2014 Share Purchase Agreement (SPA) between
AstraZeneca and the Sellers. The Sellers claim that they are owed
approximately $140m in earn-outs under the SPA. In December 2023,
after an arbitration hearing, the arbitration panel made a final
award of $46.43m in favour of the Sellers. In March 2024,
AstraZeneca filed an application with the Bavarian Supreme Court to
set aside the arbitration award.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned
by GlaxoSmithKline plc, (GSK)) entered into two worldwide,
royalty-bearing patent license agreements with AstraZeneca related
to GSK's product niraparib. In May 2021, AstraZeneca filed a
lawsuit against GSK in the Commercial Court of England and Wales
alleging that GSK had failed to pay all of the royalties due on
niraparib sales under the license agreements. In April 2023, after
trial, the trial court issued a decision in AstraZeneca's favour.
In February 2024, Court of Appeal reversed. In March 2024,
AstraZeneca filed a request for permission to appeal with the
Supreme Court of the United Kingdom.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered
to be contingent liabilities
340B Qui Tam
US proceedings
In July 2023, AstraZeneca was served with an
unsealed civil lawsuit brought by a qui tam relator on behalf of
the United States, several states, and the District of Columbia in
the US District Court for the Central District of California
(District Court). The complaint alleges that AstraZeneca violated
the US False Claims Act and state law analogues. In March 2024, the
District Court granted AstraZeneca's motion to dismiss the First
Amended Complaint without leave to amend. In April 2024, the
relator filed an appeal.
Legal proceedings brought by AstraZeneca considered to be
contingent assets
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in
the US District Court for the District of Delaware (District Court)
against the US Department of Health and Human Services (HHS)
challenging aspects of the drug price negotiation provisions of the
Inflation Reduction Act and the implementing guidance and
regulations. In March 2024, the District Court granted HHS' motions
and dismissed AstraZeneca's lawsuit.
Arkansas 340B Litigation
US proceedings
In March 2024, AstraZeneca filed a lawsuit
against the State of Arkansas alleging that the Arkansas's 340B
statute is preempted by federal law and
unconstitutional.
Other
Additional government inquiries
As is true for most, if not all, major
prescription pharmaceutical companies, AstraZeneca is currently
involved in multiple inquiries into drug marketing and pricing
practices. In addition to the investigations described above,
various law enforcement offices have, from time to time, requested
information from the Group. There have been no material
developments in those matters.
Note 7: Subsequent events
On 15 July 2024, AstraZeneca completed the
acquisition of Amolyt Pharma, a clinical-stage biotechnology
company focused on developing novel treatments for rare endocrine
diseases. AstraZeneca acquired all outstanding equity of Amolyt for
a total consideration of up to $1.05 billion, on a cash and debt
free basis. This includes an initial payment of $800m on deal
closing, subject to customary closing adjustments, and a further up
to $250m in contingent milestones-based consideration. Due to the timing of the transaction post period end, the
accounting and other disclosures will be finalised in the second
half of 2024.
Note 8
Table 25: H1 2024 - Product
Sales year-on-year analysis[15]
The CER information in respect of H1 2024
included in the Interim financial statements has not been reviewed
by PricewaterhouseCoopers LLP.
|
World
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
|
$m
|
Act % chg
|
CER % chg
|
$m
|
% chg
|
$m
|
Act % chg
|
CER % chg
|
$m
|
Act % chg
|
CER % chg
|
$m
|
Act % chg
|
CER % chg
|
Oncology
|
9,737
|
17
|
21
|
4,387
|
20
|
2,300
|
18
|
28
|
1,967
|
25
|
23
|
1,083
|
(2)
|
8
|
Tagrisso
|
3,203
|
10
|
13
|
1,282
|
16
|
919
|
8
|
16
|
628
|
16
|
15
|
374
|
(11)
|
(2)
|
Imfinzi
|
2,259
|
20
|
25
|
1,202
|
17
|
245
|
35
|
58
|
459
|
38
|
36
|
353
|
7
|
19
|
Calquence
|
1,508
|
27
|
28
|
1,048
|
21
|
75
|
82
|
n/m
|
320
|
42
|
41
|
65
|
30
|
34
|
Lynparza
|
1,450
|
6
|
9
|
607
|
5
|
320
|
15
|
26
|
398
|
9
|
8
|
125
|
(14)
|
(6)
|
Enhertu
|
249
|
n/m
|
n/m
|
-
|
-
|
161
|
n/m
|
n/m
|
57
|
n/m
|
n/m
|
31
|
n/m
|
n/m
|
Zoladex
|
549
|
19
|
27
|
8
|
20
|
415
|
22
|
31
|
77
|
16
|
14
|
49
|
2
|
12
|
Imjudo
|
136
|
35
|
38
|
88
|
30
|
7
|
n/m
|
n/m
|
16
|
n/m
|
n/m
|
25
|
(5)
|
6
|
Truqap
|
142
|
n/m
|
n/m
|
141
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
1
|
n/m
|
n/m
|
Orpathys
|
25
|
14
|
19
|
-
|
-
|
25
|
14
|
19
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
216
|
(21)
|
(15)
|
11
|
6
|
133
|
(21)
|
(15)
|
12
|
(36)
|
(36)
|
60
|
(21)
|
(12)
|
BioPharmaceuticals: CVRM
|
6,164
|
18
|
22
|
1,483
|
16
|
2,749
|
17
|
24
|
1,559
|
33
|
32
|
373
|
(8)
|
2
|
Farxiga
|
3,785
|
35
|
38
|
867
|
37
|
1,474
|
37
|
44
|
1,233
|
45
|
44
|
211
|
(15)
|
(5)
|
Brilinta
|
665
|
-
|
2
|
354
|
(1)
|
166
|
4
|
14
|
136
|
-
|
(1)
|
9
|
(26)
|
(19)
|
Crestor
|
589
|
1
|
6
|
22
|
(18)
|
475
|
4
|
9
|
22
|
(30)
|
(29)
|
70
|
3
|
13
|
Seloken/Toprol-XL
|
315
|
(8)
|
(1)
|
-
|
n/m
|
307
|
(8)
|
(1)
|
6
|
4
|
7
|
2
|
(39)
|
(37)
|
Lokelma
|
249
|
26
|
30
|
115
|
10
|
42
|
75
|
83
|
41
|
62
|
61
|
51
|
16
|
31
|
roxadustat
|
163
|
22
|
27
|
-
|
-
|
163
|
22
|
27
|
-
|
-
|
-
|
-
|
n/m
|
n/m
|
Andexxa
|
105
|
18
|
21
|
42
|
14
|
2
|
n/m
|
n/m
|
40
|
38
|
36
|
21
|
(9)
|
4
|
Wainua
|
21
|
n/m
|
n/m
|
21
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
272
|
(30)
|
(28)
|
62
|
(50)
|
120
|
(27)
|
(22)
|
81
|
(10)
|
(10)
|
9
|
(7)
|
(5)
|
BioPharmaceuticals: R&I
|
3,601
|
17
|
20
|
1,567
|
21
|
1,032
|
16
|
23
|
680
|
17
|
16
|
322
|
7
|
12
|
Symbicort
|
1,491
|
16
|
19
|
598
|
38
|
450
|
11
|
21
|
286
|
-
|
(1)
|
157
|
(4)
|
(2)
|
Fasenra
|
781
|
5
|
6
|
478
|
2
|
41
|
45
|
53
|
192
|
9
|
8
|
70
|
(2)
|
6
|
Pulmicort
|
379
|
10
|
14
|
8
|
(53)
|
317
|
16
|
22
|
37
|
1
|
(1)
|
17
|
(13)
|
(9)
|
Breztri
|
454
|
48
|
51
|
225
|
37
|
131
|
61
|
69
|
65
|
80
|
79
|
33
|
33
|
44
|
Tezspire
|
100
|
n/m
|
n/m
|
-
|
-
|
5
|
n/m
|
n/m
|
61
|
n/m
|
n/m
|
34
|
n/m
|
n/m
|
Saphnelo
|
203
|
77
|
77
|
184
|
71
|
2
|
n/m
|
n/m
|
10
|
n/m
|
n/m
|
7
|
86
|
91
|
Airsupra
|
21
|
n/m
|
n/m
|
21
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
172
|
(27)
|
(26)
|
53
|
(47)
|
86
|
(18)
|
(14)
|
29
|
3
|
2
|
4
|
(12)
|
(10)
|
BioPharmaceuticals: V&I
|
324
|
(27)
|
(24)
|
55
|
n/m
|
131
|
(12)
|
(7)
|
81
|
(28)
|
(30)
|
57
|
(68)
|
(65)
|
Synagis
|
253
|
(11)
|
(6)
|
(1)
|
n/m
|
131
|
4
|
10
|
67
|
(27)
|
(29)
|
56
|
(15)
|
(6)
|
Beyfortus
|
54
|
n/m
|
n/m
|
53
|
n/m
|
-
|
-
|
-
|
-
|
(81)
|
(61)
|
1
|
n/m
|
n/m
|
FluMist
|
8
|
n/m
|
n/m
|
3
|
n/m
|
-
|
-
|
-
|
5
|
n/m
|
97
|
-
|
n/m
|
n/m
|
COVID-19 mAbs
|
3
|
(98)
|
(98)
|
-
|
-
|
-
|
n/m
|
n/m
|
3
|
(58)
|
(59)
|
-
|
n/m
|
n/m
|
Others
|
6
|
(79)
|
(80)
|
-
|
-
|
-
|
n/m
|
n/m
|
6
|
(41)
|
(43)
|
-
|
n/m
|
n/m
|
Rare Disease
|
4,243
|
11
|
15
|
2,517
|
10
|
454
|
40
|
70
|
794
|
3
|
2
|
478
|
9
|
20
|
Ultomiris
|
1,804
|
32
|
35
|
1,032
|
27
|
66
|
n/m
|
n/m
|
411
|
32
|
31
|
295
|
42
|
58
|
Soliris
|
1,439
|
(13)
|
(8)
|
808
|
(9)
|
255
|
19
|
54
|
260
|
(29)
|
(30)
|
116
|
(33)
|
(30)
|
Strensiq
|
653
|
16
|
18
|
529
|
17
|
31
|
30
|
47
|
48
|
14
|
12
|
45
|
4
|
15
|
Koselugo
|
247
|
55
|
64
|
101
|
13
|
83
|
n/m
|
n/m
|
45
|
95
|
92
|
18
|
n/m
|
n/m
|
Kanuma
|
100
|
17
|
20
|
47
|
18
|
19
|
7
|
20
|
30
|
24
|
25
|
4
|
11
|
20
|
Other medicines
|
560
|
(9)
|
(2)
|
52
|
(24)
|
385
|
(1)
|
8
|
53
|
10
|
10
|
70
|
(35)
|
(29)
|
Nexium
|
459
|
(7)
|
1
|
47
|
(22)
|
318
|
4
|
15
|
26
|
3
|
2
|
68
|
(34)
|
(28)
|
Others
|
101
|
(17)
|
(14)
|
5
|
(40)
|
67
|
(22)
|
(18)
|
27
|
18
|
19
|
2
|
(53)
|
(49)
|
Total Product Sales
|
24,629
|
15
|
18
|
10,061
|
17
|
7,051
|
16
|
26
|
5,134
|
21
|
19
|
2,383
|
(6)
|
3
|
Table 26: Q2 2024 - Product
Sales year-on-year analysis (Unreviewed)[16]
The Q2 2024 information in respect of the three
months ended 30 June 2024 included in the Interim financial
statements has not been reviewed by PricewaterhouseCoopers
LLP.
|
World
|
US
|
Emerging
Markets
|
Europe
|
Established
RoW
|
|
$m
|
Act % chg
|
CER % chg
|
$m
|
% chg
|
$m
|
Act % chg
|
CER % chg
|
$m
|
Act % chg
|
CER % chg
|
$m
|
Act % chg
|
CER % chg
|
Oncology
|
4,976
|
14
|
18
|
2,302
|
17
|
1,098
|
11
|
22
|
1,015
|
24
|
24
|
561
|
(9)
|
2
|
Tagrisso
|
1,608
|
8
|
12
|
658
|
13
|
432
|
6
|
15
|
327
|
15
|
15
|
191
|
(12)
|
(1)
|
Imfinzi
|
1,147
|
13
|
18
|
620
|
15
|
117
|
16
|
39
|
227
|
33
|
33
|
183
|
(9)
|
3
|
Calquence
|
790
|
21
|
22
|
554
|
14
|
36
|
51
|
72
|
167
|
42
|
43
|
33
|
20
|
23
|
Lynparza
|
744
|
4
|
7
|
319
|
3
|
153
|
8
|
18
|
206
|
10
|
11
|
66
|
(15)
|
(6)
|
Enhertu
|
127
|
89
|
99
|
-
|
-
|
77
|
60
|
72
|
31
|
n/m
|
n/m
|
19
|
n/m
|
n/m
|
Zoladex
|
273
|
17
|
25
|
5
|
29
|
201
|
17
|
28
|
42
|
23
|
21
|
25
|
6
|
17
|
Imjudo
|
74
|
17
|
19
|
49
|
37
|
4
|
n/m
|
n/m
|
8
|
64
|
55
|
13
|
(38)
|
(30)
|
Truqap
|
92
|
n/m
|
n/m
|
91
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
1
|
n/m
|
n/m
|
Orpathys
|
12
|
(7)
|
(3)
|
-
|
-
|
12
|
(7)
|
(3)
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
109
|
(17)
|
(11)
|
6
|
24
|
66
|
(16)
|
(10)
|
7
|
(11)
|
(10)
|
30
|
(26)
|
(16)
|
BioPharmaceuticals: CVRM
|
3,153
|
18
|
22
|
735
|
11
|
1,384
|
17
|
24
|
843
|
38
|
38
|
191
|
(14)
|
(3)
|
Farxiga
|
1,940
|
29
|
32
|
394
|
16
|
763
|
32
|
39
|
680
|
49
|
49
|
103
|
(23)
|
(14)
|
Brilinta
|
342
|
3
|
5
|
191
|
7
|
78
|
(1)
|
6
|
69
|
1
|
1
|
4
|
(38)
|
(23)
|
Crestor
|
292
|
4
|
11
|
12
|
(2)
|
234
|
8
|
14
|
10
|
(34)
|
(32)
|
36
|
3
|
15
|
Seloken/Toprol-XL
|
150
|
(8)
|
-
|
-
|
n/m
|
146
|
(8)
|
-
|
3
|
46
|
53
|
1
|
(40)
|
(38)
|
Lokelma
|
136
|
36
|
41
|
64
|
29
|
21
|
68
|
78
|
23
|
63
|
64
|
28
|
16
|
33
|
roxadustat
|
88
|
20
|
26
|
-
|
-
|
88
|
20
|
26
|
-
|
-
|
-
|
-
|
-
|
-
|
Andexxa
|
59
|
29
|
35
|
22
|
34
|
1
|
n/m
|
n/m
|
22
|
51
|
51
|
14
|
(6)
|
8
|
Wainua
|
16
|
n/m
|
n/m
|
16
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
130
|
(26)
|
(24)
|
36
|
(45)
|
53
|
(19)
|
(14)
|
36
|
(9)
|
(8)
|
5
|
(14)
|
(12)
|
BioPharmaceuticals: R&I
|
1,797
|
21
|
24
|
830
|
23
|
444
|
23
|
34
|
350
|
21
|
21
|
173
|
8
|
14
|
Symbicort
|
722
|
20
|
25
|
299
|
49
|
197
|
12
|
25
|
143
|
4
|
5
|
83
|
(4)
|
(1)
|
Fasenra
|
423
|
4
|
5
|
268
|
-
|
19
|
33
|
46
|
99
|
11
|
11
|
37
|
3
|
11
|
Pulmicort
|
155
|
25
|
30
|
3
|
(53)
|
126
|
40
|
47
|
17
|
6
|
2
|
9
|
(18)
|
(13)
|
Breztri
|
235
|
44
|
47
|
120
|
43
|
61
|
42
|
49
|
35
|
68
|
69
|
19
|
26
|
37
|
Tezspire
|
57
|
n/m
|
n/m
|
-
|
-
|
3
|
n/m
|
n/m
|
35
|
n/m
|
n/m
|
19
|
n/m
|
n/m
|
Saphnelo
|
112
|
65
|
65
|
101
|
59
|
1
|
28
|
n/m
|
6
|
n/m
|
n/m
|
4
|
90
|
86
|
Airsupra
|
14
|
n/m
|
n/m
|
14
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
79
|
(24)
|
(22)
|
25
|
(52)
|
37
|
7
|
12
|
15
|
2
|
3
|
2
|
(6)
|
(4)
|
BioPharmaceuticals: V&I
|
112
|
28
|
42
|
28
|
n/m
|
41
|
(10)
|
4
|
7
|
(55)
|
(53)
|
36
|
36
|
55
|
Synagis
|
81
|
(6)
|
8
|
(1)
|
n/m
|
41
|
(16)
|
(2)
|
6
|
(42)
|
(42)
|
35
|
27
|
46
|
Beyfortus
|
28
|
n/m
|
n/m
|
27
|
n/m
|
-
|
-
|
-
|
-
|
n/m
|
(91)
|
1
|
n/m
|
n/m
|
FluMist
|
2
|
n/m
|
n/m
|
2
|
n/m
|
-
|
-
|
-
|
-
|
(26)
|
(21)
|
-
|
-
|
-
|
COVID-19 mAbs
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
n/m
|
n/m
|
1
|
(65)
|
(64)
|
-
|
(99)
|
(99)
|
Others
|
-
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
n/m
|
n/m
|
-
|
-
|
-
|
Rare Disease
|
2,147
|
10
|
14
|
1,311
|
10
|
203
|
35
|
67
|
392
|
3
|
3
|
241
|
7
|
18
|
Ultomiris
|
946
|
33
|
36
|
550
|
27
|
35
|
n/m
|
n/m
|
209
|
38
|
38
|
152
|
38
|
56
|
Soliris
|
700
|
(14)
|
(8)
|
398
|
(11)
|
129
|
30
|
74
|
118
|
(36)
|
(36)
|
55
|
(36)
|
(33)
|
Strensiq
|
340
|
13
|
14
|
283
|
14
|
10
|
7
|
15
|
24
|
13
|
13
|
23
|
4
|
17
|
Koselugo
|
114
|
43
|
45
|
55
|
13
|
24
|
73
|
80
|
26
|
n/m
|
n/m
|
9
|
63
|
85
|
Kanuma
|
47
|
3
|
8
|
25
|
21
|
5
|
(54)
|
(49)
|
15
|
28
|
33
|
2
|
11
|
41
|
Other medicines
|
267
|
(11)
|
(5)
|
28
|
(13)
|
179
|
(3)
|
5
|
24
|
(7)
|
(7)
|
36
|
(38)
|
(32)
|
Nexium
|
219
|
(12)
|
(5)
|
25
|
(17)
|
146
|
(2)
|
7
|
13
|
(5)
|
(5)
|
35
|
(37)
|
(32)
|
Others
|
48
|
(9)
|
(6)
|
3
|
39
|
33
|
(8)
|
(4)
|
11
|
(9)
|
(9)
|
1
|
(54)
|
(49)
|
Total Product Sales
|
12,452
|
14
|
18
|
5,234
|
16
|
3,349
|
15
|
25
|
2,631
|
23
|
23
|
1,238
|
(5)
|
5
|
Table 27: Alliance Revenue
|
|
H1
2024
|
H1
2023
|
|
|
$m
|
$m
|
Enhertu
|
|
683
|
475
|
Tezspire
|
|
180
|
105
|
Beyfortus
|
|
26
|
-
|
Other Alliance Revenue
|
|
50
|
47
|
Total
|
|
939
|
627
|
Table 28: Collaboration Revenue
|
|
H1
2024
|
H1
2023
|
|
|
$m
|
$m
|
Farxiga: sales
milestones
|
|
49
|
25
|
COVID-19 mAbs licence fees
|
|
-
|
180
|
Other Collaboration Revenue
|
|
-
|
15
|
Total
|
|
49
|
220
|
Table 29: Other operating income and
expense
|
|
H1
2024
|
H1
2023
|
|
|
$m
|
$m
|
brazikumab licence termination
funding
|
|
-
|
75
|
Divestment of US rights to Pulmicort Flexhaler
|
|
-
|
241
|
Update to the contractual relationships for
Beyfortus
(nirsevimab)
|
|
-
|
712
|
Other
|
|
127
|
135
|
Total
|
|
127
|
1,163
|
Other shareholder information
Financial calendar
Announcement of 9M and Q3 2024 results: 12
November 2024
Announcement of FY and Q4 2024 results: 6
February 2025
Dividends are normally paid as
follows:
First interim:
announced with half year results and paid in September
Second interim: announced with full year
results and paid in March
The record date for the first interim dividend
for 2024, payable on 9 September 2024, will be 9 August 2024. The
ex-dividend date will be 8 August 2024.
Conclusion of
audit tender
Following a rigorous process, the audit tender
for the Group's external audit provider has now concluded. The
Audit Committee has recommended, and the Board has endorsed, the
appointment of KPMG as the Group's external auditor for the
financial year ending 31 December 2026. A resolution will be put to
shareholders at the 2026 Annual General Meeting (AGM) to approve
this appointment. It is intended that PwC, who have been the
Group's auditor since the year ended 31 December 2017, will
continue as the Group's auditors for the years ended 31 December
2024 and 2025 and will cease to hold office at the conclusion of
the Company's 2026 AGM.
Contacts
For details on how to contact the Investor
Relations Team, please click
here. For Media contacts, click
here.
Addresses for correspondence
Registered office
|
Registrar and transfer
office
|
Swedish Central Securities
Depository
|
US depositary
Deutsche Bank Trust Company
Americas
|
1 Francis Crick
Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
|
Equiniti
Limited
Aspect
House
Spencer
Road
Lancing
West
Sussex
BN99 6DA
|
Euroclear Sweden AB
PO Box 191
SE-101 23
Stockholm
|
American Stock
Transfer
6201 15th
Avenue
Brooklyn
NY 11219
|
United
Kingdom
|
United
Kingdom
|
Sweden
|
United
States
|
+44 (0) 20 3749
5000
|
0800 389
1580
|
+46 (0) 8 402
9000
|
+1 (888) 697
8018
|
|
+44 (0) 121 415
7033
|
|
+1 (718) 921
8137
|
|
|
|
db@astfinancial.com
|
Trademarks of the AstraZeneca group of
companies appear throughout this document in italics. Medical
publications also appear throughout the document in italics.
AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol
are all trademarks of the AstraZeneca group of companies.
Trademarks of companies other than AstraZeneca that appear in this
document include: Beyfortus, a trademark of Sanofi
Pasteur Inc.; Enhertu, a trademark of Daiichi
Sankyo; Seloken, owned by
AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography);
Synagis, owned by
AstraZeneca or Sobi aka Swedish Orphan Biovitrum AB (publ).
(depending on geography); and Tezspire, a trademark of Amgen,
Inc.
Information on or accessible through
AstraZeneca's websites, including astrazeneca.com, does not
form part of and is not incorporated into this
announcement.
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global,
science-led biopharmaceutical company that focuses on the
discovery, development, and commercialisation of prescription
medicines in Oncology, Rare Disease, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com
and follow the Company on Social Media
@AstraZeneca.
Cautionary statements regarding forward-looking
statements
In order, among other things, to utilise the
'safe harbour' provisions of the US Private Securities Litigation
Reform Act of 1995, AstraZeneca (hereafter 'the Group') provides
the following cautionary statement:
This document contains certain forward-looking
statements with respect to the operations, performance and
financial condition of the Group, including, among other things,
statements about expected revenues, margins, earnings per share or
other financial or other measures. Although the Group believes its
expectations are based on reasonable assumptions, any
forward-looking statements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause
actual outcomes and results to be materially different from those
predicted. The forward-looking statements reflect knowledge and
information available at the date of preparation of this document
and the Group undertakes no obligation to update these
forward-looking statements. The Group identifies the
forward-looking statements by using the words 'anticipates',
'believes', 'expects', 'intends' and similar expressions in such
statements. Important factors that could cause actual results to
differ materially from those contained in forward-looking
statements, certain of which are beyond the Group's control,
include, among other things:
‒
the risk of failure or delay in delivery of pipeline or
launch of new medicines
‒
the risk of failure to meet regulatory or ethical
requirements for medicine development or approval
‒
the risk of failures or delays in the quality or execution of
the Group's commercial strategies
‒
the risk of pricing, affordability, access and competitive
pressures
‒
the risk of failure to maintain supply of compliant, quality
medicines
‒
the risk of illegal trade in the Group's medicines
‒
the impact of reliance on third-party goods and services
‒
the risk of failure in information technology or cybersecurity
‒
the risk of failure of critical processes
‒
the risk of failure to collect and manage data in line with
legal and regulatory requirements and strategic objectives
‒
the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce
‒
the risk of failure to meet regulatory or ethical
expectations on environmental impact, including climate
change
‒
the risk of the safety and efficacy of marketed medicines
being questioned
‒
the risk of adverse outcome of litigation and/or governmental
investigations
‒
intellectual property-related risks to the Group's
products
‒
the risk of failure to achieve strategic plans or meet
targets or expectations
‒
the risk of failure in financial control or the occurrence of
fraud
‒
the risk of unexpected deterioration in the Group's financial
position
‒
the impact that global and/or geopolitical events may have or
continue to have on these risks, on the Group's ability to continue
to mitigate these risks, and on the Group's operations, financial
results or financial condition
Glossary
1L, 2L,
etc
First line, second line, etc
ADC
Antibody drug conjugate
aHUS
Atypical haemolytic uraemic syndrome
AKT
Protein kinase B
AL
amyloidosis
Light chain amyloidosis
ANDA
Abbreviated New Drug Application (US)
ASO
Antisense oligonucleotide
ATTR-CM
Transthyretin-mediated amyloid cardiomyopathy
ATTRv / -PN / -CM
Hereditary transthyretin-mediated amyloid / polyneuropathy /
cardiomyopathy
BCMA
B-cell maturation antigen
BRCA /
m
Breast cancer gene / mutation
BTC
Biliary tract cancer
BTK
Bruton tyrosine kinase
C5
Complement component 5
CAR-T
Chimeric antigen receptor T-cell
cCRT
Concurrent chemoradiotherapy
CD19
A gene expressed in B-cells
CER
Constant exchange rates
CHMP
Committee for Medicinal Products for Human Use (EU)
CI
Confidence interval
CKD
Chronic kidney disease
CLL
Chronic lymphocytic leukaemia
COPD
Chronic obstructive pulmonary disease
COP28
28th annual United Nations (UN) climate
meeting
CRC
Colorectal cancer
CRL
Compete Response Letter
CRPC
Castration-resistant prostate cancer
CSPC
Castration-sensitive prostate cancer
CTLA-4
Cytotoxic T-lymphocyte-associated antigen 4
CVRM
Cardiovascular, Renal and Metabolism
DDR
DNA damage response
DNA
Deoxyribonucleic acid
EBITDA
Earnings before interest, tax, depreciation and
amortisation
EGFR /
m
Epidermal growth factor receptor / gene mutation
EGPA
Eosinophilic granulomatosis with polyangiitis
EPS
Earnings per share
ER
Estrogen
receptor
ERBB2
v-erb-b2 avian erythroblastic leukaemia viral oncogene homologue
2
EVH
Extravascular haemolysis
FDA
Food and Drug Agency (US)
FDC
Fixed dose combination
g
Germline, e.g. gBRCAm
GAAP
Generally Accepted Accounting Principles
GEJ
Gastro oesophageal junction
GI
Gastrointestinal
GLP1 /
-RA
Glucagon-like peptide-1 / receptor agonist
gMG
Generalised myasthenia gravis
HCC
Hepatocellular carcinoma
HER2 / +/- / low / m Human
epidermal growth factor receptor 2 / positive / negative / low
level expression / mutant
HF/ pEF / rEF
Heart failure / with preserved ejection fraction / with reduced
ejection fraction
hMPV
Human metapneumovirus
HR
Hazard ratio
HR / + /
-
Hormone receptor / positive / negative
HRD
Homologous recombination deficiency
HRR /
m
Homologous recombination repair gene / mutation
i.m.
Intramuscular injection
i.v.
Intravenous injection
IAS /
B
International Accounting
Standards / Board
ICS
Inhaled corticosteroid
IFRS
International Financial Reporting Standards
IgAN
Immunoglobulin A neuropathy
IHC
Immunohistochemistry
IL-5, IL-33,
etc
Interleukin-5, Interleukin-33, etc
IP
Intellectual Property
IVIg
Intravenous immune globulin
LABA
Long-acting beta-agonist
LAMA
Long-acting muscarinic-agonist
LS-SCLC
Limited stage small cell lung cancer
LRTD
Lower respiratory tract disease
m
Metastatic, e.g. mBTC , mCRPC, mCSPC
mAb
Monoclonal antibody
MDL
Multidistrict litigation
MET
Mesenchymal epithelial transition
NF1-PN
Neurofibromatosis type 1 with plexiform neurofibromas
n/m
Not meaningful
NMOSD
Neuromyelitis optica spectrum disorder
NRDL
National reimbursement drug list
NSCLC
Non-small cell lung cancer
OECD
Organisation for Economic
Co-operation and Development
OOI
Other operating income
ORR
Overall response rate
OS
Overall survival
PARP / i /
-1sel
Poly ADP ribose polymerase / inhibitor /-1 selective
pCR
Pathologic complete response
PCSK9
Proprotein convertase subtilisin/kexin type 9
PD
Progressive disease
PD-1
Programmed cell death protein 1
PD-L1
Programmed cell death ligand 1
PDUFA
Prescription Drug User Fee Act
PHSSR
Partnership for Health System Sustainability and
Resilience
PFS
Progression free survival
PIK3CA
Phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit
alpha
PMDI
Pressure metered dose inhaler
PNH /
-EVH
Paroxysmal nocturnal haemoglobinuria / with extravascular
haemolysis
PPI
Proton pump inhibitors
PSR
Platinum sensitive relapse
PTEN
Phosphatase and tensin homologue
Q3W, Q4W,
etc Every
three weeks, every four weeks, etc
R&D
Research and development
R&I
Respiratory & Immunology
RSV
Respiratory syncytial virus
sBLA
Supplemental biologics license application (US)
SCLC
Small cell lung cancer
s.c.
Subcutaneous injection
SEA
Severe eosinophilic asthma
SEC
Securities Exchange Commission (US)
SG&A
Sales, general and administration
SGLT2
Sodium-glucose cotransporter 2
SLL
Small lymphocytic lymphoma
SMI
Sustainable Markets Initiative
sNDA
Supplemental new drug application
SPA
Share Purchase Agreement
T2D
Type-2 diabetes
TACE
Transarterial chemoembolization
THP
A treatment regimen: docetaxel, trastuzumab and
pertuzumab
TNBC
Triple negative breast cancer
TNF
Tumour necrosis factor
TOP1
Topoisomerase I
TROP2
Trophoblast cell surface antigen 2
USPTO
US Patent and Trademark Office
V&I
Vaccines & Immune Therapies
VBP
Volume-based procurement
VLP
Virus like particle
- End of document
-