FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of November 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
9M and Q3 2023 results
AstraZeneca
9 November 2023
9M and Q3 2023 results
Strong momentum in the year to date leads to increased guidance for
Total Revenue ex COVID-19 medicines and Core EPS
Revenue and EPS summary
|
|
|
9M 2023
|
|
|
Q3 2023
|
|
|
|
|
% Change
|
|
% Change
|
|
|
$m
|
Actual
|
CER[1]
|
$m
|
Actual
|
CER
|
-
Product Sales
|
|
32,466
|
1
|
4
|
11,018
|
4
|
5
|
|
|
1,004
|
99
|
99
|
377
|
76
|
75
|
-
Collaboration Revenue
|
|
317
|
(28)
|
(28)
|
97
|
(46)
|
(47)
|
Total
Revenue
|
|
33,787
|
2
|
5
|
11,492
|
5
|
6
|
Total Revenue ex COVID-19
|
|
33,453
|
12
|
15
|
11,492
|
12
|
13
|
Reported[3] EPS[4]
|
|
$3.22
|
>2x
|
>2x
|
$0.89
|
(16)
|
(6)
|
Core[5] EPS
|
|
$5.80
|
10
|
17
|
$1.73
|
4
|
9
|
Financial
performance (9M 2023
figures unless otherwise stated, growth numbers at CER)
‒ Total
Revenue $33,787m, up 5% despite a decline of $2,896m from COVID-19
medicines[6]
‒ Excluding
COVID-19 medicines, both Total Revenue and Product Sales increased
15%
‒ Total
Revenue from Oncology medicines increased 20%,
CVRM[7] 19%,
R&I[8] 9%,
and Rare Disease 12%
‒ Core
Product Sales Gross Margin[9] of
82%, up two percentage points, reflecting the decline in sales of
lower margin COVID-19 medicines
‒ Core
Operating Margin of 35% increased by three percentage points
including the previously-announced gain from an update to the
contractual relationships for Beyfortus, totalling $712m and recorded in Core Other
operating income
‒ Core
EPS increased 17% to $5.80
‒ FY
2023 Total Revenue excluding COVID-19 medicines now expected to
increase by a low-teens percentage at CER
‒ FY
2023 Core EPS now expected to increase by a low double-digit to
low-teens percentage at CER
Pascal Soriot, Chief Executive Officer, AstraZeneca,
said:
"Our company continued its strong
growth trajectory in the third quarter with Total Revenue from our
non-COVID-19 medicines up 13% compared to last
year.
We initiated several Phase III trials
of high-potential molecules this quarter, including for
volrustomig, our PD-1/CTLA-4[10] bispecific
antibody. Our portfolio of bispecifics has the potential to replace
the first-generation checkpoint inhibitors across a range of
cancers. We also initiated a fixed dose combination study of
zibotentan with Farxiga which has the potential to significantly
improve outcomes for patients with kidney disease not well
controlled on current standard of care.
I am excited about the acceleration of
our cardiometabolic and obesity pipeline with today's licensing
agreement for ECC5004, a potential best-in-class, oral
GLP-1RA[11].
This molecule could offer an important advance, as both a
monotherapy and in combinations, for the estimated one billion
people living with cardiometabolic diseases such as type-2 diabetes
and obesity.
Given the momentum in the year to date we have increased our
full-year guidance for Total Revenue excluding COVID medicines as
well as for Core EPS."
Key milestones achieved since the prior results
announcement
‒ Key
positive read-outs: datopotamab deruxtecan in metastatic
HR[12]-positive
breast cancer (TROPION-Breast01); Imfinzi in liver cancer
(EMERALD-1); Fasenra in EGPA[13] (MANDARA)
‒ Key
regulatory approvals: EU approval for Enhertu in HER2[14]-mutant
lung cancer (DESTINY-Lung02); China approvals
for Forxiga in heart failure regardless of ejection
fraction (DELIVER); Calquence in r/rCLL[15] (ASCEND); Soliris in
NMOSD[16].
Japan approvals for Lynparza in prostate cancer
(PROpel); Enhertu in HER2-mutant lung cancer
(DESTINY-Lung02)
‒ Other
milestones: Tagrisso granted US Breakthrough Therapy Designation
and US Priority Review in combination with chemotherapy for
treatment of patients with locally advanced or
metastatic EGFRm[17] NSCLC[18] (FLAURA2); Enhertu granted
US Breakthrough Therapy Designations in HER2-positive
colorectal
cancer (DESTINY-CRC01, DESTINY-CRC02) and multiple types of
HER2-expressing tumours (DESTINY-PanTumor02)
Guidance
The Company updates its Total Revenue and Core EPS guidance for FY
2023 at CER, based on the average foreign exchange rates through
2022.
Total Revenue is expected to increase by a mid single-digit
percentage
(previously low-to-mid single-digit).
Excluding COVID-19 medicines, Total Revenue is expected to increase
by a low-teens percentage
(previously low double-digit).
Core EPS is expected to increase by a low double-digit to low-teens
percentage
(previously high single-digit to low
double-digit).
Other elements of the Income Statement are expected to be broadly
in line with the indications issued in the Company's H1 2023
results announcement.
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 October to December 2023 were to
remain at the average rates seen in September 2023, it is
anticipated that FY 2023 Total Revenue would incur a low
single-digit adverse impact versus the performance at CER, and Core
EPS would incur a mid single-digit adverse impact (previously a
low-to-mid single-digit adverse impact).
The Company's foreign exchange rate sensitivity analysis is
provided in Table 19.
Table 1: Key
elements of Total Revenue performance in Q3
2023
Revenue type
|
|
$m
|
Actual
|
CER
|
|
|
Product Sales
|
|
11,018
|
4
|
5
|
|
∗ Double-digit growth at CER in Oncology, CVRM and
Rare Disease
|
Alliance Revenue
|
|
377
|
76
|
75
|
|
∗ $266m for Enhertu (Q3 2022: $160m)
∗ $74m for Tezspire (Q3 2022: $26m)
|
Collaboration Revenue
|
|
97
|
(46)
|
(47)
|
|
∗ $71m for Beyfortus regulatory milestone
|
Total Revenue
|
|
11,492
|
5
|
6
|
|
∗ Excluding COVID-19
medicines, Q3 2023
Total Revenue increased by 12% (13% at CER)
|
Therapy areas
|
|
$m
|
Actual %
|
CER %
|
|
|
Oncology
|
|
4,664
|
15
|
17
|
|
∗ Strong performance across key medicines and
regions
∗ No milestones from Lynparza in the quarter (Q3 2022:
$75m)
|
CVRM
|
|
2,687
|
14
|
16
|
|
∗ Farxiga up
41%, Lokelma up 30% (31% at CER), roxadustat up 31% (39%
CER), Brilinta declined 2% (1% at CER)
|
R&I
|
|
1,549
|
3
|
5
|
|
∗ Fasenra up
10%, Breztri up 66% (69% CER). Saphnelo and Tezspire also continue to grow rapidly during their
launch phase, partially offset by a 12% decline (10% at CER)
in Symbicort following entry of a generic competitor in
the US during the quarter
|
V&I[19]
|
|
312
|
(64)
|
(65)
|
|
∗ $nil revenue from COVID-19 mAbs
and Vaxzevria in the quarter (Q3 2022: $536m and $180m
respectively)
∗ Beyfortus $138m,
including $50m of Product Sales from product supplied to Sanofi,
$71m of Collaboration Revenue for a regulatory milestone and $17m
of Alliance Revenue for AstraZeneca's share of gross profit outside
US
|
Rare Disease
|
|
1,974
|
13
|
14
|
|
∗ Ultomiris up
50% (49% at CER), partially offset by decline
in Soliris of 13% (12% at CER)
∗ Strensiq up
20% (21% at CER) and Koselugo up 81% reflecting strong patient
demand
|
Other Medicines
|
|
306
|
(36)
|
(32)
|
|
∗ Nexium generic
competition in Japan
|
Total Revenue
|
|
11,492
|
5
|
6
|
|
|
Regions inc. COVID-19
|
|
$m
|
Actual %
|
CER %
|
|
|
US
|
|
4,859
|
5
|
4
|
|
|
Emerging Markets
|
|
2,964
|
4
|
12
|
|
|
- China
|
|
1,452
|
(6)
|
1
|
|
|
- Ex-China Emerging Markets
|
|
1,513
|
15
|
25
|
|
|
Europe
|
|
2,392
|
16
|
9
|
|
|
Established RoW
|
|
1,276
|
(10)
|
(6)
|
|
|
Total Revenue inc. COVID-19
|
|
11,492
|
5
|
6
|
|
● Growth rates impacted by lower sales of
COVID-19 medicines (see table below)
|
Regions ex. COVID-19
|
|
$m
|
Actual %
|
CER %
|
|
|
US
|
|
4,859
|
12
|
12
|
|
|
Emerging Markets
|
|
2,964
|
8
|
16
|
|
|
- China
|
|
1,452
|
(6)
|
1
|
|
|
- Ex-China Emerging Markets
|
|
1,513
|
25
|
36
|
|
|
Europe
|
|
2,392
|
23
|
16
|
|
|
Established RoW
|
|
1,276
|
5
|
10
|
|
|
Total Revenue ex. COVID-19
|
|
11,492
|
12
|
13
|
|
|
Table 2: Key elements of financial performance in Q3
2023
Metric
|
Reported
|
Reported change
|
Core
|
Corechange
|
|
Comments[20]
|
Total Revenue
|
$11,492m
|
5% Actual 6% CER
|
$11,492m
|
5% Actual 6% CER
|
|
∗
Excluding COVID-19 medicines, Q3
2023 Total Revenue increased by 12% (13% at
CER)
∗
See Table 1 and the Total
Revenue section of this document for further
details
|
Product Sales Gross Margin
|
81%
|
+9pp Actual +10pp CER
|
81%
|
+1pp Actual +1pp CER
|
|
+
Favourable mix of sales from Oncology and Rare Disease
medicines
+
No sales of COVID-19 medicines
‒ Increasing
mix of products with profit-sharing arrangements, where AstraZeneca
books Product Sales and records an expense in
COGS[21] for
the profit share due to its partner
∗
Variations in Product Sales Gross Margin can be expected
between periods due to product seasonality, foreign exchange
fluctuations and other effects
|
R&D expense
|
$2,584m
|
5% Actual 4% CER
|
$2,485m
|
5% Actual 5% CER
|
|
+
Increased investment in the pipeline
∗
Core R&D-to-Total Revenue
ratio of 22%(Q3 2022: 21%)
∗
Year-on-year comparisons can be
impacted by differences in cost phasing driven by study starts and
execution
|
SG&A expense
|
$4,800m
|
12% Actual 12% CER
|
$3,355m
|
6% Actual 7% CER
|
|
+
Market development for recent launches and pre-launch
activities
+
Reported SG&A impacted by increased charges for legal
provisions, including a $425m charge to provisions relating to a
legal settlement in Q3 2023 (see Note 6)
∗ Core
SG&A-to-Total Revenue ratio of 29%(Q3 2022: 29%)
∗
Year-on-year comparisons can be impacted by differences in
cost phasing
|
Other operating income (and expense)[22]
|
$70m
|
-34% Actual -33% CER
|
$70m
|
-35% Actual -34% CER
|
|
‒ Discontinuation
of brazikumab development
|
Operating Margin
|
17%
|
+6pp Actual +7pp CER
|
31%
|
Stable at Actual +1pp CER
|
|
∗ See Product Sales Gross Margin, expenses and Other
operating income and expense commentary above
|
Net finance expense
|
$291m
|
-9% Actual -6% CER
|
$223m
|
-12% Actual -7% CER
|
|
+
Higher interest received on cash and short-term investments,
broadly offset by higher rates on floating debt and bond
issuances
|
Tax rate
|
17%
|
n/m Actual n/m CER
|
19%
|
+1pp Actual +1pp CER
|
|
∗ Variations in the tax rate can be expected between
periods
|
EPS
|
$0.89
|
-16% Actual -6% CER
|
$1.73
|
4% Actual 9% CER
|
|
∗ Further details of differences between Reported
and Core are shown in Table 14
|
Table 3:
Pipeline highlights since prior results
announcement
Event
|
Medicine
|
Indication / Trial
|
Event
|
Regulatory approvals and other regulatory actions
|
Lynparza
|
mCRPC[23] (1st-line)
(PROpel)
|
Regulatory approval (JP)
|
Enhertu
|
HER2m[24] NSCLC
(2nd-line+) (DESTINY-Lung02)
|
Positive CHMP Opinion (EU), Regulatory approval (EU,
JP)
|
Calquence
|
CLL[25] (ASCEND)
|
Regulatory approval (CN)
|
Forxiga
|
HFpEF[26] (DELIVER)
|
Regulatory approval (CN)
|
Soliris
|
NMOSD
|
Regulatory approval (CN)
|
Regulatory submissionsor acceptances*
|
Tagrisso
|
EGFRm NSCLC (1st-line)
(FLAURA2)
|
Regulatory submission (US, EU, CN), Priority Review
(US)
|
Imfinzi
|
NSCLC (neoadjuvant) (AEGEAN)
|
Regulatory submission (US)
|
|
capivasertib
|
HR+/HER2-negative breast cancer (2nd-line)
(CAPItello-291)
|
Regulatory
submission (CN)
|
|
roxadustat
|
Chemotherapy-induced anaemia
|
Regulatory
submission (CN)
|
|
FluMist
|
Self-administered influenza vaccine
|
Regulatory
submission (US)
|
Major Phase III data readouts and other developments
|
Imfinzi
|
Liver cancer (locoregional) (EMERALD-1)
|
Primary endpoint met
|
datopotamab deruxtecan
|
HR+/HER2-breast cancer (inoperable and/or metastatic)
(TROPION-Breast01)
|
Primary endpoint met
|
Fasenra
|
EGPA (MANDARA)
|
Primary endpoint met
|
*US, EU and China regulatory submission denotes filing
acceptance
Upcoming pipeline catalysts
For a table of anticipated timings of key trial readouts, please
refer to page 2 of the Clinical Trials Appendix, available
on www.astrazeneca.com/investor-relations.html.
Other pipeline updates
Ultomiris discontinued
plans to deliver subcutaneous administration for adults with
aHUS[27] or
PNH[28].
This decision follows persistent efforts to reliably secure the
availability of the on-body delivery system.
Table 4: Phase III trials started since 1 January
2023
Medicine
|
Trial name
|
Indication
|
datopotamab deruxtecan
|
AVANZAR
|
NSCLC (1st-line)
|
TROPION-Lung07
|
Non-squamous NSCLC (1st-line)
|
camizestrant
|
CAMBRIA-1
|
HR-positive/HER2-negative adjuvant breast cancer
|
CAMBRIA-2
|
HR-positive/HER2-negative adjuvant breast cancer
|
capivasertib
|
CAPItello-292
|
HR-positive/HER2-negative advanced breast cancer
|
volrustomig
|
eVOLVE-Cervical
|
High-risk locally advanced cervical cancer
|
eVOLVE-Lung02
|
mNSCLC (1st-line) with PD-L1[29] <50%
|
zibo/dapa
|
ZENITH High Proteinuria
|
CKD[30] and
high proteinuria
|
Saphnelo
|
DAISY
|
Systemic sclerosis
|
Tezspire
|
CROSSING
|
Eosinophilic oesophagitis
|
Breztri
|
LITHOS
|
Mild to moderate asthma
|
Breztri
|
ATHLOS
|
COPD[31]
|
pMDI[32] portfolio
|
HFO1234ze
|
Mucociliary clearance in healthy volunteers
|
pMDI portfolio
|
HFO1234ze
|
Well-controlled or partially-controlled asthma
|
tozorakimab
|
MIRANDA
|
Symptomatic COPD
|
AZD3152
|
SUPERNOVA
|
COVID-19 prophylaxis
|
Ultomiris
|
ARTEMIS
|
Cardiac surgery-associated acute kidney injury
|
Corporate and business development
In September, AstraZeneca and Verge Genomics (Verge) announced a
multi-target collaboration to identify novel drug targets for rare
neurodegenerative and neuromuscular diseases. Verge is a
clinical-stage drug discovery company using artificial intelligence
and patient tissue data. Under the terms of the four-year
agreement, Verge will receive up to $42 million, consisting of
upfront fee, equity, and near-term payments, with potential
downstream royalties. AstraZeneca will take an equity position in
Verge.
In September, AstraZeneca completed the definitive purchase and
licence agreement for a portfolio of preclinical rare disease gene
therapy programmes and enabling technologies from Pfizer
Inc. The agreement has a
total consideration of up to $1bn, plus tiered royalties on
sales.
Cellectis
In November, AstraZeneca announced a collaboration and investment
agreement with Cellectis, a clinical-stage biotechnology company,
to accelerate the development of next generation therapeutics in
areas of high unmet need, including oncology, immunology and rare
diseases. Under the terms of the collaboration agreement,
AstraZeneca will leverage the Cellectis proprietary gene editing
technologies and manufacturing capabilities, to design novel cell
and gene therapy products, strengthening AstraZeneca's growing
offering in this space. As part of the agreement, 25 genetic
targets have been exclusively reserved for AstraZeneca, from which
up to 10 candidate products could be explored for
development.
In Q4 2023, Cellectis will receive an initial payment of $105m from
AstraZeneca, which comprises a $25m upfront cash payment under the
terms of a research collaboration agreement and an $80m equity
investment. A further $140m equity investment is expected to close
in early 2024 subject to the signing of a final binding agreement.
Post-closing of this second investment, AstraZeneca will hold a
total equity stake of approximately 44% in Cellectis. Under the
terms of the research collaboration, Cellectis is also eligible to
receive an investigational new drug option fee and development,
regulatory and sales-related milestone payments, ranging from $70m
up to $220m, per each of the 10 candidate products, plus tiered
royalties.
Eccogene licence
In November, AstraZeneca and Eccogene entered into an exclusive
licence agreement for ECC5004, an investigational oral once-daily
glucagon-like peptide 1 receptor agonist (GLP-1RA) for the
treatment of obesity, type-2 diabetes and
other cardiometabolic
conditions. Preliminary results
from the Phase I trial have shown a differentiating clinical
profile for ECC5004, with good tolerability and encouraging glucose
and body weight reduction across the dose levels tested compared to
placebo.
Under the terms of the agreement, Eccogene will receive an initial
upfront payment of $185m and up to an additional $1.825bn in future
clinical, regulatory, and commercial milestones and tiered
royalties. AstraZeneca is granted exclusive global rights for the
development and commercialisation of ECC5004 for any indication in
all territories except China, where Eccogene has the right to
co-develop and co-commercialise alongside AstraZeneca.
Sustainability summary
This quarter AstraZeneca entered into long-term renewable energy
partnerships in the UK and Sweden. The UK agreement will support
the transition away from fossil fuels at Company sites in
Macclesfield, Cambridge, Luton and Speke. The Sweden agreement
corresponds to approximately 80 percent of total electricity needs
at both the Company's Gothenburg site and at Södertälje,
one of the world's largest drug manufacturing centres. See the
Sustainability section for further details.
Conference call
A conference call and webcast for investors and analysts will begin
today, 9 November 2023, at 14:00 UK time. Details can be accessed
via astrazeneca.com.
Reporting calendar
The Company intends to publish its full year and fourth quarter
results on Thursday 8 February 2024.
Operating and financial review
All narrative on growth and results in this section is based on
actual foreign exchange rates, and financial figures are in US$
millions ($m), unless stated otherwise. The performance shown in
this announcement covers the nine-month period to 30 September 2023
('the period' or '9M 2023') compared to the nine-month period to 30
September 2022 ('9M 2022'), or the three-month period to 30
September 2023 ('the quarter' or 'Q3 2023') compared to the
three-month period to 30 September 2022 ('Q3 2022'), unless stated
otherwise.
Core financial measures, EBITDA, Net debt, Product Sales Gross
Margin (formerly termed as Gross Margin), Operating Margin and CER
are non-GAAP financial measures because they cannot be derived
directly from the Group's Interim 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, such as:
‒ Amortisation
and impairment of intangible assets, including impairment reversals
but excluding any charges relating to IT assets
‒ Charges
and provisions related to restructuring programmes, which includes
charges that relate to the impact of restructuring programmes on
capitalised IT assets
‒ Alexion
acquisition-related items, primarily fair value adjustments on
acquired inventories and fair value impact of replacement employee
share awards
‒ Other
specified items, principally the imputed finance charges and fair
value movements relating to contingent consideration on business
combinations or asset acquisitions, 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 63 of the Annual Report and Form
20-F Information 2022.
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 (formerly termed Gross Margin) is the
percentage by which Product Sales exceeds the Cost of Sales,
calculated by dividing the difference between the two by the sales
figure. 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.
Total Revenue
Table 5:
Therapy area and medicine performance - Product Sales and Total
Revenue
|
|
9M 2023
|
Q3 2023
|
|
|
|
|
% Change
|
|
|
% Change
|
Product Sales
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Oncology
|
|
12,692
|
38
|
17
|
20
|
4,389
|
38
|
16
|
17
|
- Tagrisso
|
|
4,380
|
13
|
7
|
10
|
1,465
|
13
|
5
|
6
|
- Imfinzi [33]
|
|
3,102
|
9
|
53
|
56
|
1,126
|
10
|
53
|
54
|
- Lynparza
|
|
2,070
|
6
|
6
|
9
|
702
|
6
|
7
|
8
|
- Calquence
|
|
1,839
|
5
|
25
|
26
|
654
|
6
|
16
|
15
|
- Enhertu
|
|
178
|
1
|
>3x
|
>3x
|
73
|
1
|
>3x
|
>3x
|
- Orpathys
|
|
33
|
-
|
(3)
|
4
|
12
|
-
|
6
|
13
|
- Zoladex
|
|
699
|
2
|
(3)
|
5
|
239
|
2
|
-
|
5
|
- Faslodex
|
|
217
|
1
|
(16)
|
(10)
|
64
|
1
|
(21)
|
(16)
|
-
Others
|
|
174
|
1
|
(36)
|
(32)
|
54
|
-
|
(33)
|
(30)
|
BioPharmaceuticals: CVRM
|
|
7,887
|
23
|
14
|
18
|
2,683
|
23
|
14
|
16
|
- Farxiga
|
|
4,358
|
13
|
36
|
40
|
1,554
|
14
|
41
|
41
|
- Brilinta
|
|
996
|
3
|
(2)
|
-
|
331
|
3
|
(2)
|
(1)
|
- Lokelma
|
|
300
|
1
|
44
|
49
|
102
|
1
|
30
|
31
|
-
roxadustat
|
|
208
|
1
|
41
|
51
|
74
|
1
|
31
|
39
|
- Andexxa
|
|
129
|
-
|
16
|
19
|
40
|
-
|
(3)
|
(5)
|
- Crestor
|
|
860
|
3
|
4
|
11
|
275
|
2
|
(1)
|
6
|
- Seloken/Toprol-XL
|
|
496
|
1
|
(30)
|
(23)
|
153
|
1
|
(36)
|
(29)
|
- Onglyza
|
|
180
|
1
|
(12)
|
(8)
|
53
|
-
|
(20)
|
(17)
|
- Bydureon
|
|
123
|
-
|
(40)
|
(40)
|
35
|
-
|
(48)
|
(49)
|
-
Others
|
|
237
|
1
|
(16)
|
(13)
|
66
|
1
|
(23)
|
(21)
|
BioPharmaceuticals: R&I
|
|
4,517
|
13
|
5
|
8
|
1,451
|
13
|
2
|
3
|
- Symbicort
|
|
1,842
|
5
|
(4)
|
(1)
|
555
|
5
|
(12)
|
(10)
|
- Fasenra
|
|
1,134
|
3
|
12
|
13
|
389
|
3
|
10
|
10
|
- Breztri
|
|
478
|
1
|
69
|
73
|
171
|
1
|
66
|
69
|
- Saphnelo
|
|
191
|
1
|
>2x
|
>2x
|
76
|
1
|
>2x
|
>2x
|
- Tezspire
|
|
51
|
-
|
>10x
|
>10x
|
21
|
-
|
>10x
|
>10x
|
- Pulmicort
|
|
493
|
1
|
3
|
10
|
148
|
1
|
2
|
7
|
- Bevespi
|
|
42
|
-
|
(2)
|
(2)
|
13
|
-
|
(5)
|
(4)
|
- Daliresp/Daxas
|
|
41
|
-
|
(74)
|
(74)
|
11
|
-
|
(79)
|
(79)
|
- Others
|
|
245
|
1
|
(30)
|
(27)
|
67
|
1
|
(31)
|
(28)
|
BioPharmaceuticals: V&I
|
|
667
|
2
|
(82)
|
(81)
|
224
|
2
|
(74)
|
(74)
|
- COVID-19
mAbs[34]
|
|
126
|
-
|
(91)
|
(90)
|
-
|
-
|
n/m
|
n/m
|
- Vaxzevria
|
|
28
|
-
|
(98)
|
(98)
|
-
|
-
|
n/m
|
n/m
|
- Beyfortus
|
|
52
|
-
|
n/m
|
n/m
|
50
|
-
|
n/m
|
n/m
|
- Synagis
|
|
383
|
1
|
-
|
6
|
99
|
1
|
(5)
|
(1)
|
- FluMist
|
|
78
|
-
|
32
|
28
|
75
|
1
|
28
|
23
|
Rare Disease
|
|
5,793
|
17
|
11
|
12
|
1,974
|
17
|
13
|
14
|
- Soliris
|
|
2,429
|
7
|
(17)
|
(15)
|
781
|
7
|
(13)
|
(12)
|
- Ultomiris
|
|
2,141
|
6
|
56
|
58
|
777
|
7
|
50
|
49
|
- Strensiq
|
|
847
|
3
|
23
|
24
|
285
|
2
|
20
|
21
|
- Koselugo
|
|
246
|
1
|
65
|
65
|
87
|
1
|
81
|
81
|
- Kanuma
|
|
130
|
-
|
17
|
18
|
44
|
-
|
21
|
19
|
Other Medicines
|
|
910
|
3
|
(27)
|
(22)
|
297
|
3
|
(27)
|
(22)
|
- Nexium
|
|
735
|
2
|
(25)
|
(20)
|
244
|
2
|
(22)
|
(17)
|
-
Others
|
|
175
|
1
|
(33)
|
(31)
|
53
|
-
|
(43)
|
(41)
|
Product Sales
|
|
32,466
|
96
|
1
|
4
|
11,018
|
96
|
4
|
5
|
Alliance Revenue
|
|
1,004
|
3
|
99
|
99
|
377
|
3
|
76
|
75
|
Collaboration Revenue
|
|
317
|
1
|
(28)
|
(28)
|
97
|
1
|
(46)
|
(47)
|
Total Revenue
|
|
33,787
|
100
|
2
|
5
|
11,492
|
100
|
5
|
6
|
Table 6: Alliance Revenue
|
|
9M 2023
|
Q3 2023
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Enhertu
|
|
741
|
74
|
>2x
|
>2x
|
266
|
70
|
66
|
65
|
Tezspire
|
|
179
|
18
|
>4x
|
>4x
|
74
|
20
|
>2x
|
>2x
|
Vaxzevria:
royalties
|
|
-
|
-
|
n/m
|
n/m
|
-
|
-
|
n/m
|
n/m
|
Other royalty income
|
|
59
|
6
|
16
|
15
|
18
|
5
|
10
|
9
|
Other Alliance Revenue
|
|
25
|
2
|
>2x
|
>2x
|
19
|
5
|
>3x
|
>3x
|
Total
|
|
1,004
|
100
|
99
|
99
|
377
|
100
|
76
|
75
|
Table 7: Collaboration Revenue
|
|
9M 2023
|
Q3 2023
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
COVID-19 mAbs: licence fees
|
|
180
|
57
|
n/m
|
n/m
|
-
|
-
|
n/m
|
n/m
|
Farxiga: sales
milestones
|
|
28
|
9
|
n/m
|
n/m
|
3
|
3
|
n/m
|
n/m
|
tralokinumab: sales milestones
|
|
20
|
6
|
(82)
|
(82)
|
20
|
21
|
(50)
|
(50)
|
Lynparza: regulatory
milestones
|
|
-
|
-
|
n/m
|
n/m
|
-
|
-
|
n/m
|
n/m
|
Beyfortus: regulatory
milestones
|
|
71
|
22
|
n/m
|
n/m
|
71
|
73
|
n/m
|
n/m
|
Other Collaboration Revenue
|
|
18
|
6
|
(76)
|
(76)
|
3
|
3
|
(95)
|
(95)
|
Total
|
|
317
|
100
|
(28)
|
(28)
|
97
|
100
|
(46)
|
(47)
|
Table 8: Total Revenue by therapy area
|
|
9M 2023
|
Q3 2023
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
Oncology
|
|
13,458
|
40
|
17
|
20
|
4,664
|
41
|
15
|
17
|
BioPharmaceuticals
|
|
13,599
|
40
|
(10)
|
(7)
|
4,548
|
40
|
(4)
|
(2)
|
- CVRM
|
|
7,926
|
23
|
14
|
19
|
2,687
|
23
|
14
|
16
|
- R&I
|
|
4,729
|
14
|
6
|
9
|
1,549
|
13
|
3
|
5
|
- V&I
|
|
944
|
3
|
(74)
|
(73)
|
312
|
3
|
(64)
|
(65)
|
Rare Disease
|
|
5,793
|
17
|
11
|
12
|
1,974
|
17
|
13
|
14
|
Other Medicines
|
|
937
|
3
|
(30)
|
(26)
|
306
|
3
|
(36)
|
(32)
|
Total
|
|
33,787
|
100
|
2
|
5
|
11,492
|
100
|
5
|
6
|
Table 9: Total
Revenue by region
|
|
9M 2023
|
Q3 2023
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
US
|
|
13,940
|
41
|
6
|
6
|
4,859
|
42
|
5
|
4
|
Emerging Markets
|
|
9,242
|
27
|
3
|
10
|
2,964
|
26
|
4
|
12
|
- China
|
|
4,495
|
13
|
(2)
|
5
|
1,452
|
13
|
(6)
|
1
|
- Ex-China
|
|
4,747
|
14
|
8
|
15
|
1,513
|
13
|
15
|
25
|
Europe
|
|
6,765
|
20
|
5
|
5
|
2,392
|
21
|
16
|
9
|
Established RoW
|
|
3,840
|
11
|
(16)
|
(9)
|
1,276
|
11
|
(10)
|
(6)
|
Total
|
|
33,787
|
100
|
2
|
5
|
11,492
|
100
|
5
|
6
|
Table 10:
Total Revenue by region - excluding COVID-19
medicines
|
|
9M 2023
|
Q3 2023
|
|
|
|
|
% Change
|
|
|
% Change
|
|
|
$m
|
% Total
|
Actual
|
CER
|
$m
|
% Total
|
Actual
|
CER
|
US
|
|
13,940
|
42
|
14
|
14
|
4,859
|
42
|
12
|
12
|
Emerging Markets
|
|
9,038
|
27
|
12
|
20
|
2,964
|
26
|
8
|
16
|
- China
|
|
4,495
|
13
|
(1)
|
6
|
1,452
|
13
|
(6)
|
1
|
- Ex-China
|
|
4,544
|
14
|
28
|
37
|
1,513
|
13
|
25
|
36
|
Europe
|
|
6,748
|
20
|
14
|
14
|
2,392
|
21
|
23
|
16
|
Established RoW
|
|
3,726
|
11
|
-
|
8
|
1,276
|
11
|
5
|
10
|
Total
|
|
33,453
|
100
|
12
|
15
|
11,492
|
100
|
12
|
13
|
Oncology
Oncology Total Revenue of $13,458m in 9M 2023 increased by 17% (20%
at CER), representing 40% of overall Total Revenue (9M 2022: 35%).
There was no Lynparza Collaboration Revenue in 9M 2023 (9M
2022: $250m), and Enhertu Alliance Revenue was $741m (9M 2022: $335m).
Product Sales increased by 17% (20% at CER) in 9M 2023 to $12,692m,
reflecting new launches and expanded reimbursement across key
brands; partially offset by declines in legacy
medicines.
Tagrisso
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
4,380
|
|
1,679
|
1,261
|
821
|
619
|
Actual change
|
|
7%
|
|
14%
|
4%
|
6%
|
(4%)
|
CER change
|
|
10%
|
|
14%
|
11%
|
6%
|
5%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Increased global demand
for Tagrisso in adjuvant and 1st-line settings combined
with expanded reimbursement in the adjuvant
setting
|
US
|
|
∗ Continued growth in demand in 1st-line and
adjuvant settings
|
Emerging Markets
|
|
∗ Growing demand in adjuvant and
1st-line settings offset by impact of NRDL[35] renewal
price in China effective March 2023, some additional impact in
China in the third quarter resulting from reduced promotional
activities following the government campaign announced at the end
of July 2023
|
Europe
|
|
∗ Increased demand growth in 1st-line and growing
adjuvant demand
|
Established RoW
|
|
∗ Increased demand in 1st-line and adjuvant settings
offset by mandatory price reduction in Japan effective June
2023
|
Imfinzi and Imjudo
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
3,102
|
|
1,708
|
270
|
547
|
577
|
Actual change
|
|
53%
|
|
55%
|
20%
|
36%
|
90%
|
CER change
|
|
56%
|
|
55%
|
31%
|
35%
|
>2x
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Includes $161m of Total Revenue
from Imjudo, which launched in Q4 2022 following
approvals in the US for patients with unresectable liver cancer
(HIMALAYA) and Stage IV NSCLC (POSEIDON)
∗ Growth across all regions, driven
by recent launches (BTC[36],
HCC[37],
Stage IV NSCLC) and established indications (Stage III NSCLC,
SCLC[38])
|
US
|
|
∗ Continued demand growth for BTC and HCC
indications, increased uptake in SCLC
|
Emerging Markets
|
|
∗ Growth across markets driven by BTC launches and
recovery of diagnosis and treatment rates following the COVID-19
pandemic, slightly offset by decreased promotional activities in
China due to the government campaign announced at the end of July
2023
|
Europe
|
|
∗ Competitive share gain in SCLC, and expanded
reimbursement for new launch indications (BTC, HCC and Stage IV
NSCLC)
|
Established RoW
|
|
∗ Growth driven by launch of HCC and BTC and
increased share across indications in Japan
|
Lynparza
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
2,070
|
|
902
|
409
|
543
|
216
|
Actual change
|
|
(6%)
|
|
1%
|
14%
|
(27%)
|
7%
|
CER change
|
|
(3%)
|
|
1%
|
24%
|
(27%)
|
16%
|
Product Sales
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
2,070
|
|
902
|
409
|
543
|
216
|
Actual change
|
|
6%
|
|
1%
|
14%
|
10%
|
7%
|
CER change
|
|
9%
|
|
1%
|
24%
|
10%
|
16%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Lynparza remains
the leading medicine in the PARP[39] inhibitor
class globally across four tumour types (ovarian, breast, prostate,
pancreatic), as measured by total prescription
volume
∗ No regulatory milestones received in the
period
|
US
|
|
∗ Continued share growth
within the PARP inhibitor class, offset by declining class use and
the label restriction in 2nd-line ovarian cancer effective
September 2023
|
Emerging Markets
|
|
∗ Increased demand, offset by price
reduction in China associated with NRDL renewal that took effect
March 2023 for ovarian cancer indications
(PSR[40] and
BRCAm[41] 1st-line
maintenance) and new NRDL enlistment in prostate cancer (PROfound)
as well as some impact in the third quarter resulting from reduced
promotional activities following the government campaign announced
end of July 2023
|
Europe
|
|
∗ Demand growth from increased uptake in 1st-line
HRD-positive ovarian cancer, gBRCAm[42] HER2-negative
early breast cancer and mCRPC, offset by reduced use in 2nd-line
ovarian cancer and pricing
∗ Total Revenue in the prior year period included
$250m of milestones
|
Established RoW
|
|
∗ Growth driven by increased uptake in testing and
use in 1st-line HRD-positive ovarian cancer
|
Enhertu
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
919
|
|
518
|
179
|
204
|
17
|
Actual change
|
|
>2x
|
|
>2x
|
>3x
|
>2x
|
>3x
|
CER change
|
|
>2x
|
|
>2x
|
>3x
|
>2x
|
>3x
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited
(Daiichi Sankyo) and AstraZeneca, amounted to $1,844m in 9M 2023
(9M 2022: $750m)
∗ AstraZeneca's Total Revenue of $919m in the period
includes $741m of Alliance Revenue from its share of gross profit
and royalties in territories where Daiichi Sankyo records product
sales
|
US
|
|
∗ US in-market sales, recorded by Daiichi Sankyo,
amounted to $1,087m in 9M 2023 (9M 2022: $532m)
∗ Increased demand across launched indications. Q3
2023 impacted by HER2-low bolus depletion
|
Emerging Markets
|
|
∗ Continued uptake driven by recent approvals and
launches including strong demand growth in China following
HER2-positive and HER2-low breast cancer
launches
|
Europe
|
|
∗ Continued growth driven by increasing adoption in
HER2-positive and HER2-low metastatic breast
cancer
|
Established RoW
|
|
∗ In Japan, AstraZeneca receives a mid-single-digit
percentage royalty on sales made by Daiichi
Sankyo
|
Calquence
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
1,839
|
|
1,337
|
69
|
353
|
80
|
Actual change
|
|
25%
|
|
12%
|
>2x
|
76%
|
64%
|
CER change
|
|
26%
|
|
12%
|
>2x
|
77%
|
74%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Increased penetration globally;
leading BTKi[43] in
key markets
|
US
|
|
∗ Leadership maintained in growing BTKi class,
sustained leading share in the front-line setting, offset by some
competitive impact in relapsed refractory setting and increased
utilisation of free goods program in Q3
|
EU
|
|
∗ Solid growth continued amidst growing competitive
pressure
∗ Increased new patients starts following expanded
access in key markets
|
Orpathys
Orpathys Total Revenue of $34m declined 1% (6% increase at CER),
(9M 2022: $35m), following its inclusion in the updated NRDL
in China from March 2023, for the treatment of patients with NSCLC
with MET exon 14 skipping alterations.
Other Oncology medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
|
Zoladex
|
|
723
|
(2%)
|
5%
|
∗ Underlying growth due to continued demand growth
in Emerging Markets, partially offset by price reduction in China
following NRDL renewal
|
Faslodex
|
|
217
|
(16%)
|
(10%)
|
∗ Generic competition
|
Other Oncology
|
|
174
|
(36%)
|
(32%)
|
∗ Generic
competition
|
BioPharmaceuticals
BioPharmaceuticals Total Revenue decreased by 10% (7% at CER) in 9M
2023 to $13,599m, representing 40% of overall Total Revenue (9M
2022: 45%). The decline was driven by COVID-19 medicines, partially
offset by strong growth from Farxiga and newer R&I
medicines.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 14% (19% at CER) to $7,926m in 9M
2023, driven by the strong Farxiga performance, and represented 23% of overall
Total Revenue (9M 2022: 21%).
Farxiga
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
4,389
|
|
1,000
|
1,655
|
1,356
|
378
|
Actual change
|
|
37%
|
|
34%
|
35%
|
42%
|
35%
|
CER change
|
|
41%
|
|
34%
|
43%
|
41%
|
45%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Farxiga volume
is growing faster than the overall SGLT2[44] market
in most major regions, fuelled by launches in heart failure and
CKD
∗ Additional benefit from continued growth in the
overall SGLT2 inhibitor class
|
US
|
|
∗ Growth driven by heart failure
and CKD for patients with and without T2D[45] resulting
in an increasing market share
|
Emerging Markets
|
|
∗ Solid growth despite generic competition in some
markets
|
Europe
|
|
∗ Benefited from the addition of cardiovascular
outcomes trial data to the label and growth in
HFrEF[46],
CKD and the HFpEF approval in February 2023. ESC[47] guidelines
updated in August 2023 to also include treatment of patients with
HFpEF
∗ Continued strong volume growth in the quarter and
expanded class leadership in several key
markets
|
Established RoW
|
|
∗ In Japan, AstraZeneca sells to collaborator Ono
Pharmaceutical Co., Ltd, which records in-market sales. Continued
volume growth driven by HF and CKD launches. Generics launched in
Canada in the third quarter
|
Brilinta
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
996
|
|
551
|
224
|
203
|
18
|
Actual change
|
|
(2%)
|
|
2%
|
1%
|
(5%)
|
(54%)
|
CER change
|
|
-
|
|
2%
|
10%
|
(5%)
|
(51%)
|
Region
|
|
Drivers and commentary
|
US
|
|
∗ Sales in the third quarter benefitted from channel
inventory movements
|
Emerging Markets
|
|
∗ Sales declined by 16% (4% at CER) in the third
quarter driven by tender phasing
|
Europe
|
|
∗ Sales partly impacted by
clawbacks
|
Established RoW
|
|
∗ Sales decline driven by generic entry in
Canada
|
Lokelma
Lokelma Total Revenue
increased 44% (49% at CER) to $300m with strong demand growth in
all regions.
Roxadustat
Total Revenue increased 40% (50% at CER) to $212m, benefitting from
increased demand in both the dialysis- and non-dialysis-dependent
populations
Andexxa
Andexxa Total
Revenue increased 7% (9% at CER) to $129m.
Other CVRM medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
|
Crestor
|
|
862
|
4%
|
11%
|
∗ Continued sales growth in Emerging Markets, partly
offset by declines in the US and Established
RoW
|
Seloken
|
|
496
|
(30%)
|
(23%)
|
∗ Ongoing impact of China VBP
implementation
|
Onglyza
|
|
180
|
(12%)
|
(8%)
|
∗ Continued decline for DPP-IV
class
|
Bydureon
|
|
123
|
(40%)
|
(40%)
|
∗ Continued competitive
pressures
|
Other CVRM
|
|
237
|
(16%)
|
(13%)
|
|
BioPharmaceuticals - R&I
Total Revenue of $4,729m from R&I medicines in 9M 2023
increased 6% (9% at CER) and represented 14% of overall Total
Revenue (9M 2022: 14%). This reflected growth
in Fasenra, Tezspire, Breztri and Saphnelo, offsetting a decline
in Symbicort and other mature brands.
Fasenra
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
1,134
|
|
718
|
48
|
262
|
106
|
Actual change
|
|
12%
|
|
11%
|
62%
|
14%
|
(1%)
|
CER change
|
|
13%
|
|
11%
|
69%
|
14%
|
6%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Retained market share leadership in severe
eosinophilic asthma across major markets
|
US
|
|
∗ Expanded leadership in eosinophilic
asthma and maintained total share in a growing market, leading to
double-digit volume growth, partially offset by managed
market price difference
|
Emerging Markets
|
|
∗ Continued strong volume
growth driven by launch acceleration across key
markets
|
Europe
|
|
∗ Expanded leadership in
severe eosinophilic asthma, with strong volume growth partially
offset by price in some markets
|
Established RoW
|
|
∗ Maintained class leadership in Japan while market
growth remained stable
|
Breztri
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
478
|
|
263
|
123
|
55
|
37
|
Actual change
|
|
69%
|
|
60%
|
73%
|
>2x
|
48%
|
CER change
|
|
73%
|
|
60%
|
86%
|
>2x
|
58%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Continued to gain market share
within the growing FDC[48] triple
class across major markets
|
US
|
|
∗ Consistent share
growth within the FDC triple class in
new-to-brand[49] and
the total market
|
Emerging Markets
|
|
∗ Maintained market share
leadership in China with strong triple FDC class
penetration
|
Europe
|
|
∗ Sustained growth across
markets as new launches continue to progress
|
Established RoW
|
|
∗ Increased market share
gains within COPD in Japan and strong launch performance in
Canada
|
Tezspire
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
230
|
|
179
|
-
|
28
|
23
|
Actual change
|
|
>5x
|
|
>4x
|
-
|
n/m
|
n/m
|
CER change
|
|
>5x
|
|
>4x
|
-
|
n/m
|
n/m
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Tezspire is
approved in the US, EU and Japan (as well as other countries) for
the treatment of severe asthma without biomarker or phenotypic
limitation
∗ Amgen records sales in the US, and AstraZeneca
records its share of US gross profits as Alliance Revenue.
AstraZeneca books Product Sales in markets outside the
US
∗ Combined sales of Tezspire by AstraZeneca and Amgen were $438m in 9M
2023
|
US
|
|
∗ Increased new-to-brand market share with majority
of patients new to biologics
∗ Pre-filled pen approved
in February 2023
|
Europe
|
|
∗ Achieved and maintained new-to-brand leadership in
key markets
∗ Pre-filled pen approved in January
2023
|
Established RoW
|
|
∗ Japan maintained new-to-brand
leadership
|
Saphnelo
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
191
|
|
178
|
1
|
5
|
7
|
Actual change
|
|
>2x
|
|
>2x
|
n/m
|
>4x
|
>3x
|
CER change
|
|
>2x
|
|
>2x
|
n/m
|
>4x
|
>3x
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Demand acceleration in
the US, and additional growth driven by ongoing launches in Europe
and Japan
|
Symbicort
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
1,842
|
|
589
|
600
|
408
|
245
|
Actual change
|
|
(4%)
|
|
(18%)
|
26%
|
(8%)
|
(12%)
|
CER change
|
|
(1%)
|
|
(18%)
|
36%
|
(8%)
|
(7%)
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Symbicort remained the global market leader within a
stable ICS[50]/LABA[51] class
|
US
|
|
∗ Generic competition entered the US market in the
third quarter, leading to price and volume share declines
|
Emerging Markets
|
|
∗ Strong underlying
demand. Growth in China benefitted from the post-COVID-19
recovery at the start of the year
|
Europe
|
|
∗ Continued price and
volume erosion from generics and a slowing overall
market
|
Established RoW
|
|
∗ Generic erosion in
Japan
|
Other R&I medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
|
Pulmicort
|
|
493
|
3%
|
10%
|
∗ 80% of revenues from
Emerging Markets
∗ China market share has
stabilised, with VBP having been in effect for over 12
months
|
Bevespi
|
|
42
|
(2%)
|
(2%)
|
|
Daliresp
|
|
41
|
(74%)
|
(74%)
|
∗ Impacted by uptake of
multiple generics following loss of exclusivity in the
US
|
Other R&I
|
|
278
|
(41%)
|
(38%)
|
∗ Collaboration Revenue of $20m (9M 2022:
$110m)
∗ Product Sales of $245m decreased 30% (27% at CER)
due to generic competition
|
BioPharmaceuticals - V&I
Total Revenue from V&I medicines declined by 74% (73% at CER)
to $944m (9M 2022: $3,673m) and represented 3% of overall Total
Revenue (9M 2022: 11%). In Q3 2023, no revenue was generated from
COVID-19 medicines.
COVID-19 mAbs
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
306
|
|
-
|
185
|
7
|
114
|
Actual change
|
|
(79%)
|
|
n/m
|
11%
|
(97%)
|
(51%)
|
CER change
|
|
(78%)
|
|
n/m
|
11%
|
(96%)
|
(45%)
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ All Product Sales in 9M 2023 were derived from
sales of Evusheld in the first quarter
|
Emerging Markets
|
|
∗ $180m license fee from
Serum Institute of India in Q2 2023 recorded as Collaboration
Revenue
|
Vaxzevria
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
28
|
|
-
|
18
|
10
|
-
|
Actual change
|
|
(98%)
|
|
n/m
|
(98%)
|
(97%)
|
n/m
|
CER change
|
|
(98%)
|
|
n/m
|
(98%)
|
(97%)
|
n/m
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Revenue in the period decreased by 98% due to the
conclusion of Vaxzevria contracts
|
Other V&I medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
|
Beyfortus
|
|
139
|
n/m
|
n/m
|
∗ In Q3 2023 AstraZeneca
reported $50m of Product Sales, $17m of Alliance
Revenue, and also $71m
of Collaboration Revenue relating to a regulatory
milestone
∗ The Product Sales
relates to sales to Sanofi of Beyfortus product manufactured by
AstraZeneca. In Q3 Product Sales benefitted from stock building for
the 2023-2024 RSV[52] season
∗ The Alliance Revenue
consists of AstraZeneca's 50% share of gross profits on sales
of Beyfortus in
major markets outside the US. AstraZeneca will also book 25% of
revenues in rest of world markets. AstraZeneca has no participation
in US profits or losses
|
Synagis
|
|
383
|
-
|
6%
|
∗ Performance broadly
in-line with prior year
|
FluMist
|
|
88
|
49%
|
45%
|
∗ $10m milestone received
from Daiichi Sankyo in the second quarter
following FluMist approval in
Japan
|
Rare Disease
Total Revenue from Rare Disease medicines increased by 11% (12% at
CER) in 9M 2023 to $5,793m, representing 17% of overall Total
Revenue (9M 2022: 16%).
Performance was driven by the continued growth and durability of
the C5[53] franchise,
and also the strength of Strensiq and Koselugo patient demand.
Ultomiris
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
2,141
|
|
1,260
|
47
|
495
|
339
|
Actual change
|
|
56%
|
|
63%
|
38%
|
43%
|
54%
|
CER change
|
|
58%
|
|
63%
|
39%
|
42%
|
68%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Growth in neurology indications, expansion into
new markets and continued conversion from Soliris
∗ Quarter-on-quarter variability in revenue growth
can be expected due to Ultomiris every eight-week dosing schedule and lower
average annual treatment cost per patient compared
to Soliris
|
US
|
|
∗ Growth in naïve patients in
gMG[54] and
NMOSD as well as successful conversion
from Soliris across
shared indications
|
Emerging Markets
|
|
∗ Continued progress following launches in new
markets
|
Europe
|
|
∗ Strong demand generation following launches in new
markets, particularly in neurology indications, as well as
accelerated conversion from Soliris in key markets
|
Established RoW
|
|
∗ Continued conversion from Soliris and strong demand following new launches,
particularly NMOSD in Japan
|
Soliris
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
2,429
|
|
1,313
|
338
|
530
|
248
|
Actual change
|
|
(17%)
|
|
(22%)
|
55%
|
(15%)
|
(36%)
|
CER change
|
|
(15%)
|
|
(22%)
|
74%
|
(15%)
|
(31%)
|
Region
|
|
Drivers and commentary
|
US
|
|
∗ Decline driven by successful conversion
of Soliris patients to Ultomiris in PNH, aHUS and gMG, partially offset
by Soliris growth in NMOSD
|
Emerging Markets
|
|
∗ Continued progress, launching in new
markets
|
Europe,Established RoW
|
|
∗ Decline driven by successful conversion
from Soliris to Ultomiris, partially offset by growth in
NMOSD
|
Strensiq
Total Revenue
|
|
Worldwide
|
|
US
|
Emerging Markets
|
Europe
|
Established RoW
|
9M 2023 $m
|
|
847
|
|
690
|
29
|
64
|
64
|
Actual change
|
|
23%
|
|
26%
|
14%
|
9%
|
12%
|
CER change
|
|
24%
|
|
26%
|
16%
|
8%
|
22%
|
Region
|
|
Drivers and commentary
|
Worldwide
|
|
∗ Strong patient demand particularly in the US and
Japan
|
Other Rare Disease medicines
Total Revenue
|
|
$m
|
Actual
|
CER
|
Commentary
|
Koselugo
|
|
246
|
65%
|
65%
|
∗ Driven by patient demand and expansion in new
markets
|
Kanuma
|
|
130
|
17%
|
18%
|
∗ Continued demand growth in ex-US
markets
|
Other medicines (outside the main therapy areas)
Total Revenue
|
|
$m
|
Actual
|
CER
|
Commentary
|
Nexium
|
|
748
|
(30%)
|
(25%)
|
∗ Generic launches in Japan in the latter part of
2022
|
Others
|
|
189
|
(31%)
|
(29%)
|
∗ Continued impact of
generic competition
|
Financial performance
Table 11:
Reported Profit and Loss
|
|
9M 2023
|
9M 2022
|
% Change
|
Q3 2023
|
Q3 2022
|
% Change
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
Total Revenue
|
|
33,787
|
33,144
|
2
|
5
|
11,492
|
10,982
|
5
|
6
|
- Product Sales
|
|
32,466
|
32,200
|
1
|
4
|
11,018
|
10,590
|
4
|
5
|
- Alliance Revenue
|
|
1,004
|
504
|
99
|
99
|
377
|
214
|
76
|
75
|
- Collaboration Revenue
|
|
317
|
440
|
(28)
|
(28)
|
97
|
178
|
(46)
|
(47)
|
Cost of
sales
|
|
(5,960)
|
(9,491)
|
(37)
|
(38)
|
(2,095)
|
(2,982)
|
(30)
|
(31)
|
Gross profit
|
|
27,827
|
23,653
|
18
|
22
|
9,397
|
8,000
|
17
|
20
|
Product Sales Gross Margin
|
|
81.6%
|
70.5%
|
+11pp
|
+12pp
|
81.0%
|
71.8%
|
+9pp
|
+10pp
|
Distribution
expense
|
|
(394)
|
(380)
|
4
|
6
|
(129)
|
(126)
|
2
|
2
|
% Total Revenue
|
|
1.2%
|
1.1%
|
-
|
-
|
1.1%
|
1.1%
|
-
|
-
|
R&D
expense
|
|
(7,862)
|
(7,137)
|
10
|
12
|
(2,584)
|
(2,458)
|
5
|
4
|
% Total Revenue
|
|
23.3%
|
21.5%
|
-2pp
|
-2pp
|
22.5%
|
22.4%
|
-
|
-
|
SG&A
expense
|
|
(13,845)
|
(13,798)
|
-
|
2
|
(4,800)
|
(4,277)
|
12
|
12
|
% Total Revenue
|
|
41.0%
|
41.6%
|
+1pp
|
+1pp
|
41.8%
|
38.9%
|
-3pp
|
-2pp
|
OOI[55] &
expense
|
|
1,233
|
325
|
>3x
|
>3x
|
70
|
106
|
(34)
|
(33)
|
% Total Revenue
|
|
3.6%
|
1.0%
|
+3pp
|
+3pp
|
0.6%
|
1.0%
|
-
|
-
|
Operating profit
|
|
6,959
|
2,663
|
>2x
|
>2x
|
1,954
|
1,245
|
57
|
69
|
Operating Margin
|
|
20.6%
|
8.0%
|
+13pp
|
+14pp
|
17.0%
|
11.3%
|
+6pp
|
+7pp
|
Net finance
expense
|
|
(945)
|
(936)
|
1
|
1
|
(291)
|
(324)
|
(9)
|
(6)
|
Joint
ventures and associates
|
|
(12)
|
(4)
|
>2x
|
>2x
|
(11)
|
1
|
n/m
|
n/m
|
Profit before tax
|
|
6,002
|
1,723
|
>3x
|
>3x
|
1,652
|
922
|
79
|
91
|
Taxation
|
|
(1,000)
|
668
|
n/m
|
n/m
|
(274)
|
720
|
n/m
|
n/m
|
Tax
rate
|
|
17%
|
-39%
|
|
|
17%
|
-78%
|
|
|
Profit after tax
|
|
5,002
|
2,391
|
>2x
|
>2x
|
1,378
|
1,642
|
(16)
|
(6)
|
Earnings per share
|
|
$3.22
|
$1.54
|
>2x
|
>2x
|
$0.89
|
$1.06
|
(16)
|
(6)
|
Table 12:
Reconciliation of Reported Profit before tax to
EBITDA
|
|
9M 2023
|
9M 2022
|
% Change
|
Q3 2023
|
Q3 2022
|
% Change
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
Reported Profit before tax
|
|
6,002
|
1,723
|
>3x
|
>3x
|
1,652
|
922
|
79
|
91
|
Net finance expense
|
|
945
|
936
|
1
|
1
|
291
|
324
|
(9)
|
(6)
|
Joint ventures and associates
|
|
12
|
4
|
>2x
|
>2x
|
11
|
(1)
|
n/m
|
n/m
|
Depreciation, amortisation and impairment
|
|
4,060
|
4,000
|
2
|
3
|
1,282
|
1,334
|
(4)
|
(4)
|
EBITDA
|
|
11,019
|
6,663
|
65
|
77
|
3,236
|
2,579
|
25
|
32
|
EBITDA for the comparative 9M 2022 was negatively impacted by
$3,175m unwind of inventory fair value uplift recognised on the
acquisition of Alexion. EBITDA for the comparative Q3 2022 was
negatively impacted by $857m unwind of inventory fair value uplift
recognised on the acquisition of Alexion. This unwind had a $78m
negative impact on 9M 2023 and a $23m negative impact on Q3 2023.
It will continue to be minimal and will unwind fully over the next
quarter.
Table 13:
Reconciliation of Reported to Core financial measures: 9M
2023
9M 2023
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisitionof Alexion
|
Other[56]
|
Core
|
Core
% Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross profit
|
|
27,827
|
133
|
24
|
82
|
(4)
|
28,062
|
4
|
8
|
Product Sales Gross Margin
|
|
81.6%
|
|
|
|
|
82.4%
|
+1pp
|
+2pp
|
Distribution expense
|
|
(394)
|
-
|
-
|
-
|
-
|
(394)
|
4
|
6
|
R&D expense
|
|
(7,862)
|
117
|
386
|
5
|
1
|
(7,353)
|
5
|
7
|
SG&A expense
|
|
(13,845)
|
163
|
2,863
|
7
|
1,107
|
(9,705)
|
5
|
8
|
Total operating expense
|
|
(22,101)
|
280
|
3,249
|
12
|
1,108
|
(17,452)
|
5
|
7
|
Other operating income & expense
|
|
1,233
|
(61)
|
-
|
-
|
-
|
1,172
|
>3x
|
>3x
|
Operating profit
|
|
6,959
|
352
|
3,273
|
94
|
1,104
|
11,782
|
10
|
16
|
Operating Margin
|
|
20.6%
|
|
|
|
|
34.9%
|
+2pp
|
+3pp
|
Net finance expense
|
|
(945)
|
-
|
-
|
-
|
220
|
(725)
|
(1)
|
(2)
|
Taxation
|
|
(1,000)
|
(81)
|
(617)
|
(22)
|
(329)
|
(2,049)
|
12
|
19
|
EPS
|
|
$3.22
|
$0.17
|
$1.72
|
$0.05
|
$0.64
|
$5.80
|
10
|
17
|
Table 14:
Reconciliation of Reported to Core financial measures: Q3
2023
Q3 2023
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisitionof Alexion
|
Other[57]
|
Core
|
Core
% Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross profit
|
|
9,397
|
15
|
8
|
25
|
(1)
|
9,444
|
6
|
7
|
Product Sales Gross Margin
|
|
81.0%
|
|
|
|
|
81.4%
|
+1pp
|
+1pp
|
Distribution expense
|
|
(129)
|
-
|
-
|
-
|
-
|
(129)
|
3
|
2
|
R&D expense
|
|
(2,584)
|
48
|
49
|
2
|
-
|
(2,485)
|
5
|
5
|
SG&A expense
|
|
(4,800)
|
61
|
957
|
3
|
424
|
(3,355)
|
6
|
7
|
Total operating expense
|
|
(7,513)
|
109
|
1,006
|
5
|
424
|
(5,969)
|
6
|
6
|
Other operating income & expense
|
|
70
|
-
|
-
|
-
|
-
|
70
|
(35)
|
(34)
|
Operating profit
|
|
1,954
|
124
|
1,014
|
30
|
423
|
3,545
|
4
|
9
|
Operating Margin
|
|
17.0%
|
|
|
|
|
30.8%
|
-
|
+1pp
|
Net finance expense
|
|
(291)
|
-
|
-
|
-
|
68
|
(223)
|
(12)
|
(7)
|
Taxation
|
|
(274)
|
(29)
|
(189)
|
(7)
|
(125)
|
(624)
|
8
|
13
|
EPS
|
|
$0.89
|
$0.06
|
$0.53
|
$0.01
|
$0.24
|
$1.73
|
4
|
9
|
Profit and Loss drivers
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 the
nine months 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. Vaxzevria sales, which are dilutive to Product Sales Gross
Margin, declined substantially
‒ Dilutive
effects from product mix. The rising contribution of Product Sales
with profit sharing arrangements (Lynparza,
Enhertu and Tezspire) has a negative impact on Product Sales Gross
Margin because AstraZeneca records product revenues in certain
markets but pays away a share of the gross profit to its
collaboration partners
‒ Dilutive
effects from geographic mix. Emerging Markets, where Product Sales
Gross Margin tends to be below the Company average, grew as a
proportion of Total Revenue excluding COVID-19
medicines
‒ 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:
‒ Recent
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
productivity
‒ Reported
R&D expense was also impacted by intangible asset
impairments
SG&A expense
‒ The
change in SG&A expense (Reported and Core) in the period was
driven primarily by market development activities for
launches
‒ Reported
SG&A expense was also impacted by amortisation of intangible
assets related to the Alexion acquisition and other acquisitions
and collaborations
‒ Reported
SG&A expense was also impacted by a $510m charge to provisions
relating to a legal settlement in Q2 2023 with Bristol-Myers Squibb
and Ono Pharmaceutical, and a $425m charge to provisions in Q3 2023
for product liability litigations related
to Nexium and Prilosec. The prior nine month period was impacted by a
$775m legal settlement with Chugai Pharmaceutical Co.
Ltd
Other operating income and expense
‒ Reported
and Core Other operating income and expense in the period included
a $712m gain resulting from an update to the contractual
relationships for Beyfortus (nirsevimab), a $241m gain on the disposal
of the US rights to Pulmicort Flexhaler, and other disposal proceeds on the sale of
tangible assets, and royalties on certain
medicines
‒ In
the third quarter Reported and Core Other operating income
decreased by $36m and $37m respectively, principally due to the
discontinuation of brazikumab development. Prior to this,
AstraZeneca received quarterly development contributions for
brazikumab development from AbbVie, which were recognised as Other
operating income
Net finance expense
‒ Reported
Net finance expense was impacted by the discount unwind on
acquisition-related liabilities. Core Net finance expense reduced
by 1% (2% at CER) with higher interest received on cash and
short-term investments, broadly offset by higher rates on floating
debt and bond issuances
Taxation
‒ The
effective Reported Tax rate for the nine months to 30 September
2023 was 17% (9M 2022: (39%)) and the effective Core Tax rate was
19% (9M 2022: 18%). The Q3 2022 effective Reported Tax rate was
lower as it included a one-time favourable adjustment of $883m
relating to deferred taxes arising from an internal reorganisation
to integrate the Alexion business
‒ The
cash tax paid for the nine months to 30 September 2023 was $1,710m
(9M 2022: $1,335m), representing 28% of Reported Profit before tax
(9M 2022: 77%)
‒ On
20 June 2023, Finance (No.2) Act 2023 was substantively enacted in
the UK, introducing a global minimum effective tax rate of 15%. The
legislation implements a domestic top-up tax and a multinational
top-up tax, effective for accounting periods starting on or after
31 December 2023. The Company is currently assessing the impact of
these rules upon its financial statements. The Company has
applied the exception under the IAS 12 'Income Taxes' amendment for
recognising and disclosing information about deferred tax assets
and liabilities related to top-up income taxes
Table 15: Cash
Flow summary
|
|
9M 2023
|
9M 2022
|
Change
|
|
|
$m
|
$m
|
$m
|
Reported Operating profit
|
|
6,959
|
2,663
|
4,296
|
Depreciation, amortisation and impairment
|
|
4,060
|
4,000
|
60
|
Decrease in working capital and short-term provisions
|
|
150
|
3,458
|
(3,308)
|
Gains on disposal of intangible assets
|
|
(247)
|
(88)
|
(159)
|
Fair value movements on contingent consideration arising
from
business combinations
|
|
202
|
293
|
(91)
|
Non-cash and other movements
|
|
(623)
|
(973)
|
350
|
Interest paid
|
|
(826)
|
(608)
|
(218)
|
Taxation paid
|
|
(1,710)
|
(1,335)
|
(375)
|
Net cash inflow from operating activities
|
|
7,965
|
7,410
|
555
|
Net cash inflow before financing activities
|
|
4,978
|
4,699
|
279
|
Net cash outflow from financing activities
|
|
(6,276)
|
(6,465)
|
189
|
In 9M 2022, the Reported Operating profit of $2,663m included a
negative impact of $3,175m relating to the unwind of the inventory
fair value uplift recognised on the acquisition of Alexion. This
was offset by a corresponding item (positive impact of $3,175m) in
Decrease in working capital and short-term provisions. Overall, the
unwind of the fair value uplift had no impact on Net cash inflow
from operating activities. This unwind had $78m negative impact on
9M 2023 Reported Operating profit and offsetting positive impact on
Working capital movements, and will continue to be minimal in the
next quarter. As a result of the update to the contractual
relationships between AstraZeneca, Sobi and Sanofi relating to the
future sales of Beyfortus (nirsevimab) in the US, a gain of $712m has
been recorded in non-cash and other movements, with no overall net
impact on the Net cash inflow from operating
activities.
Included within Net cash inflow before financing activities is a
movement in the profit-participation liability of $190m, including
a cash receipt from Sobi in Q1 2023 after achievement of a
regulatory milestone. The associated cash flow is presented within
investing activities.
The decrease in Net cash outflow from financing activities of $189m
is primarily driven by the Issue of loans and borrowings of
$3,816m, offset by the increase in Repayment of loans and
borrowings of $3,394m.
Capital expenditure
Capital expenditure amounted to $836m in the nine months to 30
September 2023 (9M 2022: $719m).
Table 16: Net
debt summary
|
|
At 30
Sep 2023
|
At 31
Dec 2022
|
At 30
Sep 2022
|
|
|
$m
|
$m
|
$m
|
Cash and cash equivalents
|
|
4,871
|
6,166
|
4,458
|
Other investments
|
|
244
|
239
|
440
|
Cash and investments
|
|
5,115
|
6,405
|
4,898
|
Overdrafts and short-term borrowings
|
|
(515)
|
(350)
|
(743)
|
Lease liabilities
|
|
(979)
|
(953)
|
(878)
|
Current instalments of loans
|
|
(4,857)
|
(4,964)
|
(4,665)
|
Non-current instalments of loans
|
|
(22,225)
|
(22,965)
|
(23,013)
|
Interest-bearing loans and borrowings (Gross debt)
|
|
(28,576)
|
(29,232)
|
(29,299)
|
Net derivatives
|
|
90
|
(96)
|
(141)
|
Net debt
|
|
(23,371)
|
(22,923)
|
(24,542)
|
Net debt increased by $448m in the nine months to 30 September 2023
to $23,371m. 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
0.700% Notes due 2024, 1.200% Notes due 2026, 4.875% Notes due
2028, 1.750% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes
due 2031 and 4.875% Notes due 2033 (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
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 and reports on
Form 6-K with our quarterly financial results as filed or furnished
with the SEC[58] 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 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 17:
Obligor group summarised Statement of comprehensive
income
|
|
9M 2023
|
9M 2022
|
|
|
$m
|
$m
|
Total Revenue
|
|
-
|
-
|
Gross profit
|
|
-
|
-
|
Operating loss
|
|
(2)
|
(3)
|
Loss for the period
|
|
(695)
|
(404)
|
Transactions with subsidiaries that are not issuers or
guarantors
|
|
9,758
|
502
|
Table 18:
Obligor group summarised Statement of financial
position
|
|
At 30 Sep 2023
|
At 30 Sep 2022
|
|
|
$m
|
$m
|
Current assets
|
|
6
|
5
|
Non-current assets
|
|
-
|
-
|
Current liabilities
|
|
(4,760)
|
(3,067)
|
Non-current liabilities
|
|
(22,077)
|
(22,556)
|
Amounts due from subsidiaries that are not issuers or
guarantors
|
|
12,921
|
7,349
|
Amounts due to subsidiaries that are not issuers or
guarantors
|
|
(295)
|
(301)
|
Foreign exchange
The Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign exchange contracts against
the individual companies' reporting currency. Foreign exchange
gains and losses on forward contracts for transactional hedging are
taken to profit or loss. In addition, the Company's external
dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment
date.
Table 19:
Currency sensitivities
The Company provides the following currency-sensitivity
information:
|
|
|
Average
rates vs. USD
|
|
Annual impact ($m) of 5% strengthening (FY2023 average rate vs. FY 2022
average) [59]
|
Currency
|
Primary Relevance
|
|
FY 2022[60]
|
YTD 2023[61]
|
Change
(%)
|
Sep 2023[62]
|
Change[63]
(%)
|
|
Total Revenue
|
Core Operating Profit
|
EUR
|
Total Revenue
|
|
0.95
|
0.92
|
3
|
0.94
|
1
|
|
323
|
159
|
CNY
|
Total Revenue
|
|
6.74
|
7.04
|
(4)
|
7.30
|
(8)
|
|
309
|
174
|
JPY
|
Total Revenue
|
|
131.59
|
138.18
|
(5)
|
147.71
|
(11)
|
|
181
|
122
|
Other[64]
|
|
|
|
|
|
|
|
|
385
|
202
|
GBP
|
Operating expense
|
|
0.81
|
0.80
|
1
|
0.81
|
0
|
|
46
|
(92)
|
SEK
|
Operating expense
|
|
10.12
|
10.59
|
(4)
|
11.08
|
(9)
|
|
7
|
(55)
|
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
‒ Hosted
the first dedicated side-event on Chronic Kidney Disease (CKD) "How
improving kidney health can transform health systems for all"
during the 78th United Nations General Assembly (UNGA) meeting in
New York, with public, private and patient voices represented.
During UNGA, the Company also engaged with the cancer community on
access, services within universal health coverage (UHC) and the
need for investment in cancer and non-communicable diseases
(NCDs)
‒ Continued
to make a high-level contribution to the work of the Partnership
for Health System Sustainability and Resilience (PHSSR), which
provides a valuable platform for dialogue with policymakers, the
Company and other stakeholders. In Canada, a workshop with
participation from the Minister of Health of Quebec fed into the
discussions on transformation of Quebec's health system. In Japan,
AstraZeneca's Chair Michel Demaré participated in a PHSSR
roundtable co-hosted by the British Embassy, which focused on
health equity and digital healthcare. PHSSR also engaged at leading
global and regional healthcare events, including the European
Health Forum Gastein, the Global Congress on Population, Health and
Development, ICHOM 2023 and the World Health Summit in
Berlin
‒ Ruud
Dobber, EVP BioPharmaceuticals Business Unit, delivered the opening
keynote address at the POLITICO EU Healthcare Summit in Brussels
where he called for bold action and collaboration across the
healthcare ecosystem to support early diagnosis and treatment. He
highlighted the need for regulatory frameworks that accelerate
access to medical innovation, as well as the urgency to combat the
effects of the climate crisis on health
‒ Marked
World Heart Day and the ninth anniversary of Healthy Heart Africa
(HHA)'s launch, by convening African health stakeholders to take
stock of the programme's achievements and share insights on the
critical role of public-private partnerships in supporting primary
healthcare. Speakers included representatives of Ministries of
Health from nine countries and HHA implementing partners, with more
than 70 attendees. HHA has trained more than 11,000 healthcare
workers and conducted over 43 million blood pressure screenings,
identifying 8.6 million with elevated blood pressure since launch,
moving closer to the programme ambition of 10 million by 2025, and
achieving one million screenings per month since February 2023
(data as at end of September 2023)
‒ Young
Health Programme is now active in 40 countries, with new programmes
launched in Costa Rica and Taiwan. Through the Young Health
Programme Impact Fellowship, the Company supported a delegation of
17 young health leaders from 13 countries to attend One Young World
2023 in Belfast. Three of these changemakers joined AstraZeneca
leadership in on-stage appearances, discussing their impact on NCD
prevention for young people in their communities. AstraZeneca and
Plan International UK were awarded 'Highly Commended' at the
Corporate Engagement Awards for Best Educational
Programme
Environmental protection
‒ Entered
into an agreement in Sweden with Statkraft, Europe's largest
renewable energy producer, on wind power deliveries that will
increase the supply of renewable electricity in Sweden. The
agreement is based on the commissioning of new wind farms. Under
the agreement, AstraZeneca commits to purchasing 200 gigawatt-hours
per year for 10 years, equivalent to two terawatt-hours. This
corresponds to approximately 80 percent of total electricity needs
at both the Company's Gothenburg site and at Södertälje,
the largest manufacturing centre and one of the world's largest
drug manufacturing centres
‒ Agreed
a 15-year partnership with Future Biogas to establish the first
unsubsidised industrial-scale supply of biomethane in the UK. This
biomethane will support the transition away from fossil fuels at
Company sites in Macclesfield, Cambridge, Luton and Speke. A new
biomethane plant will add renewable energy capacity to existing UK
infrastructure and supply more than 100 gigawatt hours of
biomethane, equivalent to the heat needs of more than 8,000 homes.
Using crops grown locally as part of diverse crop rotations, the
plant will also contribute to the development of a circular
economy, supporting UK farms with sustainable land management
practices
‒ In
China, CEO Pascal Soriot and EVP and China President Leon Wang
witnessed the launch of the Sustainable Markets Initiative (SMI)
China Council Health Working Group. Inspired by the SMI Health
Systems Task Force, members of this new partnership will
collaborate to accelerate the delivery of a net zero health system,
for domestic and global impact. AstraZeneca China will co-chair
this Working Group, which comprises China-based organisations and
Chinese affiliates of global pharmaceutical
companies
‒ In
the U.S., advocated for climate action and sustainable healthcare
reform during Climate Week NYC by convening high-level
representatives from the US government, WHO, civil society and
philanthropy at a plenary event with Climate Group on "Addressing
the climate-health-equity nexus: The path to a sustainable future".
The Company also discussed accelerating health sector
decarbonisation at the Forbes Sustainability Leaders Summit in a
session on "How the healthcare industry is responding to climate
change" alongside US National Academy of Medicine President Dr.
Victor J. Dzau. Furthermore, the Company participated in an event
on water stewardship
‒ Contributed
to a joint report on Advancing water stewardship through supplier
collaboration in partnership with the World Wide Fund for
Nature
‒ Ranked
in first position for climate action in a new STAT Report "Climate
rankings: How top drug companies measure up in combating climate
change", which noted that "Companies like AstraZeneca are the
exception in an industry that, as a whole, could be doing much more
to measure and report its climate impacts, according to
organizations that pool data on this topic"
‒ Received
the EcoVadis Gold Medal for 2023, improving on the 2022 Silver
rating. AstraZeneca was scored in four areas: Environment, Ethics,
Labor and Human Rights, and Sustainable Procurement, and received
an Advanced rating in the Environment and Human Rights
categories
‒ Recognised
with two awards from My Green Lab and the International Institute
for Sustainable Laboratories' in the 2023 Freezer Challenge: the
Top Organization Award and the Small Size Lab Award for our site in
Gothenburg, Sweden
Ethics and transparency
‒ Received
three supplier diversity awards from the Diversity for Science
Alliance including 2023 Company of the year
‒ Launched
Global Ethics training ahead of Global Ethics Day in October, an
annual reminder to employees of the Company's commitment to high
ethical standards in all areas of AstraZeneca's business, marking
the day with local and virtual events and an #EmpoweringEthics
employee social campaign
‒ Held
an internal Power of Diversity panel discussion with members of the
Company's Global Inclusion & Diversity (I&D) Council on the
topic of putting an I&D lens over our AZ Values. This focused
on building a sense of belonging through allyship, mutual support
and the sharing of diverse perspectives. Supporting materials were
made available through employee communication
channels
Research and development
This section covers R&D events and milestones that have
occurred since the prior results announcement on 28 July 2023,
up to and including events on 8 November 2023.
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 during the
quarter: the 2023 World Conference on Lung Cancer (WCLC) in
September and the 2023 European Society of Medical Oncology (ESMO)
in October. At WCLC, AstraZeneca presented more than 40 abstracts
featuring eight approved and potential new medicines, including
nine oral presentations and a late-breaking plenary Presidential
Symposium presentation of results from the FLAURA2 Phase III trial
of Tagrisso plus chemotherapy in
1st-line EGFRm NSCLC. At ESMO, AstraZeneca presented nearly 100
abstracts featuring 19 approved and potential new medicines
including 26 oral presentations and two late-breaking Presidential
Symposia of the TROPION-Lung01 and TROPION-Breast 01 Phase III
trials of monotherapy Dato-DXd versus conventional chemotherapy in
lung and breast cancers.
Tagrisso
Event
|
|
|
Commentary
|
Breakthrough Designation
|
US
|
|
Tagrisso in combination
with chemotherapy for the treatment of adult patients with locally
advanced or metastatic EGFRm lung cancer. (FLAURA2, August
2023)
|
Presentation: WCLC
|
FLAURA2
|
|
Interim analysis of the Phase III FLAURA2 trial, presented at WCLC,
demonstrated Tagrisso plus
chemotherapy extended median PFS[65] by
nearly nine months and reduced the risk of disease progression by
38% in EGFRm advanced lung cancer vs. Tagrisso monotherapy.
(September 2023)
|
Priority Review
|
US
|
|
Tagrisso in combination
with chemotherapy for the treatment of adult patients with locally
advanced or metastatic EGFRm lung cancer. (FLAURA2, October
2023)
|
Presentation: ESMO
|
FLAURA2 CNS analysis
|
|
Prespecified exploratory analysis of the Phase III FLAURA2 trial,
presented at ESMO, showed Tagrisso plus
chemotherapy demonstrated a 42% improvement in
CNS[66] PFS
vs. Tagrisso monotherapy
in patients with EGFRm advanced lung cancer and brain metastases at
baseline, representing 40% of patients in the trial, as assessed by
blinded independent central review. (October
2023)
|
Imfinzi and Imjudo
Event
|
|
|
Commentary
|
Positive Opinion
|
EU
|
|
The Committee for Medicinal Products for Human Use (CHMP) issued a
positive opinion for Type II Extension of Indication Variation
for Imfinzi as monotherapy for the first line treatment
of adults with advanced or unresectable HCC. (HIIMALAYA, July
2023)
|
Presentation: ESMO
|
MATTERHORN
|
|
Interim analysis of the Phase III MATTERHORN III trial, presented
at ESMO, showed that Imfinzi in
combination with standard-of-care FLOT[67] neoadjuvant
chemotherapy demonstrated a statistically significant and
clinically meaningful 12% improvement in the key secondary endpoint
of pCR[68] vs.
neoadjuvant chemotherapy alone for patients with resectable,
early-stage and locally gastric and GEJ[69] cancers.
(October 2023)
|
Phase III data readout
|
EMERALD-1
|
|
Positive high-level results from the EMERALD-1 Phase III trial
showed Imfinzi in
combination with TACE[70] and
bevacizumab demonstrated a statistically significant and clinically
meaningful improvement in the primary endpoint of PFS versus TACE
alone in patients with HCC eligible for embolisation. The trial
continues to follow the secondary endpoint of OS[71].
(November 2023)
|
Lynparza
Event
|
|
|
Commentary
|
Approval
|
Japan
|
|
Lynparza in combination
with abiraterone and prednisolone for the treatment of adult
patients with BRCAm mCRPC. (August 2023)
|
Label restriction
|
US
|
|
Restriction of the Lynparza indication for the maintenance treatment of
adult patients with recurrent epithelial ovarian, fallopian tube,
or primary peritoneal cancer who are in a complete or partial
response to platinum-based chemotherapy to the BRCAm (germline or
somatic) patient population only. (September
2023)
|
Presentation: ESMO
|
DUO-E
(Lynparza and Imfinzi)
|
|
Primary analysis of the Phase III DUO-E Phase III trial, presented
at ESMO, showed that treatment with Imfinzi plus chemotherapy followed by
either Imfinzi monotherapy or Imfinzi plus Lynparza demonstrated a reduction in the risk of
disease progression or death, by 45% and 29%, respectively, vs.
chemotherapy alone in patients with advanced or recurrent
endometrial cancer. (October 2023)
|
Enhertu
Event
|
|
|
Commentary
|
Approval
|
Japan
|
|
For the treatment of adult patients with unresectable advanced or
recurrent NSCLC with HER2 (ERBB2) mutations that has progressed
after chemotherapy. (DESTINY-Lung02, August 2023)
|
Breakthrough Designation
|
US
|
|
For the treatment of adult patients with unresectable or metastatic
HER2-positive (IHC[72] 3+)
solid tumours that have progressed following prior treatment and
who have no alternative treatment options. (DESTINY-PanTumor02,
August 2023)
|
|
|
|
For the treatment of patients with HER2-positive (IHC 3+)
metastatic colorectal cancer who have received two or more prior
regimens. (DESTINY-CRC01, DESTINY-CRC02, August 2023)
|
Presentation: WCLC
|
DESTINY-Lung02
|
|
Results from the primary analysis of the DESTINY-Lung02 Phase II
trial, presented at WCLC, showed Enhertu provided a median PFS of 9.9 months at a
dose of 5.4mg/kg, and 15.4 months at a dose of 6.4mg/kg, with a
favourable safety profile that confirm 5.4mg/kg is the optimal dose
in this tumour type. (September 2023)
|
Approval
|
EU
|
|
As monotherapy for the treatment of adult patients with advanced
NSCLC whose tumours have an activating HER2
(ERBB2[73])
mutation and who require systemic therapy following platinum-based
chemotherapy with or without immunotherapy. (DESTINY-Lung02,
October 2023)
|
Presentation: ESMO
|
DESTINY-PanTumor02
|
|
Primary analysis of the Phase II DESTINY-PanTumor02 trial,
presented at ESMO, showed that treatment
with Enhertu resulted
in confirmed ORR[74] of
37.1%, a median PFS of 6.9 months and median OS of 13.4 months in
previously treated patients across multiple HER2-expressing
advanced solid tumours. (October 2023)
|
Calquence
Event
|
|
|
Commentary
|
Approval
|
China
|
|
For the treatment of adult patients with CLL or
SLL[75] who
have received at least one prior therapy. (ASCEND, September
2023)
|
datopotamab deruxtecan (Dato-Dxd)
Event
|
|
|
Commentary
|
Presentation: WCLC
|
TROPION-Lung04
|
|
Results from a planned interim analysis of the Phase Ib
TROPION-Lung04 trial, presented at WCLC, showed that Dato-DXd in
combination with Imfinzi, with or without carboplatin demonstrated
objective response rates of 77% and 50% and disease control rates
of 92% and 93% respectively, with no new safety signals in patients
with previously untreated advanced or metastatic NSCLC without
actionable genomic alterations. (September
2023)
|
Presentation: ESMO
|
BEGONIA
|
|
Updated results from the Phase Ib/II BEGONIA trial, presented at
ESMO, showed Dato-DXd plus Imfinzi demonstrated a confirmed objective response
rate of 79% and a median PFS of 13.8 months in patients with
previously untreated advanced or metastatic triple-negative breast
cancer. (October 2023)
|
Presentation: ESMO
|
TROPION-Lung01
|
|
Primary analysis for the Phase III TROPION-Lung01 trial, presented
at ESMO, showed that Dato-DXd reduced the risk of disease
progression or death by 25% in the overall population and by 37% in
non-squamous tumours vs. docetaxel in patients with previously
treated NSCLC. (October 2023)
|
Presentation: ESMO
|
TROPION-Breast01
|
|
Primary analysis for the Phase III TROPION-Breast01 trial,
presented at ESMO, showed that Dato-DXd reduced the risk of disease
progression or death by 37%, providing a two-month median PFS
benefit, and was well tolerated in the post-endocrine therapy
setting vs. investigator's choice of chemotherapy in patients with
inoperable or metastatic HR-positive, HER2-low or HER2-negative
breast cancer previously treated with endocrine-based therapy and
at least one systemic therapy. (October 2023)
|
Other oncology pipeline
Event
|
|
|
Commentary
|
Trial update
|
MONETTE
|
|
Phase II trial of ceralasertib + Imfinzi in unresectable or advanced melanoma and
resistance to PD-(L)1 inhibition stopped enrolment following a
pre-specified futility (efficacy) assessment. There were no
concerning safety signals identified at this interim analysis or
during the two prior data review meetings.
|
Presentation: ASCO Virtual Plenary
|
NCT04805307
|
|
Interim analysis for the Phase I trial (NCT04805307) of CMG901
(Claudin 18.2 ADC[76])
demonstrated promising clinical efficacy in patients with heavily
pre-treated CLDN18.2-positive gastric/GEJ cancer, with a manageable
safety profile. (November 2023)
|
BioPharmaceuticals - CVRM
AstraZeneca presented 19 abstracts, including 10 oral presentations
and five late-breaking presentations, at the European Society of
Cardiology (ESC) Congress in August, including data highlighting
the opportunities for improved management in heart failure, and
AstraZeneca's leadership across the interconnectedness of chronic
diseases. At the American Society of Nephrology's (ASN) Kidney Week
in November, AstraZeneca presented 53 abstracts showcasing the
strength of its portfolio, including new ZORA and REVOLUTIONIZE
real-world evidence data for Lokelma and compelling next-wave pipeline innovation
with results from the ZENITH-CKD Phase IIb trial for
zibotentan/dapagliflozin.
Farxiga
Event
|
|
|
Commentary
|
Approval
|
China
|
|
Approved in China to reduce the risk of cardiovascular death,
hospitalisation for HF[77] or
urgent HF visits in adults with symptomatic chronic HF. (June
2023)
|
Data
|
T2NOW
|
|
Positive data from the Phase III T2NOW trial, demonstrating a
significant reduction in A1C in patients aged 10-17 years compared
to patients receiving placebo. (October 2023)
|
Data
|
DAPA-MI
|
|
Primary endpoint met, non-registrational trial. (August
2023)
|
zibotentan/dapagliflozin
Event
|
|
|
Commentary
|
Presentation:
ASN
|
ZENITH-CKD
|
|
Phase IIb data showed statistically
significant and clinically meaningful reductions in urinary
albumin-to-creatinine ratio (UACR), used to
assess albuminuria, at 12 weeks compared
with the standard of care of dapagliflozin alone. After 12 weeks
of treatment, the UACR difference of
zibotentan/dapagliflozin versus dapagliflozin alone was -33.7% (90%
CI -42.5 to -23.5; p<0.001) for high-dose (1.5 mg zibotentan
/ 10 mg dapagliflozin) and
-27.0% (90% CI -38.4 to -13.6; p=0.002) for low dose
(0.25
mg/10mg). (November
2023)
|
Eplontersen
Event
|
|
|
Commentary
|
Orphan Drug Designation
|
EU
|
|
Orphan drug designation received for the treatment of
ATTR[78].
(October 2023)
|
BioPharmaceuticals - R&I
AstraZeneca presented new data across its inhaled, biologic and
early science respiratory portfolio at the European Respiratory
Society (ERS) International Congress 2023. The company presented
over 90 abstracts, including 18 oral presentations, which focused
on unmet needs in severe asthma, chronic obstructive pulmonary
disease and other acute respiratory diseases. Data
from Fasenra and Tezspire advanced clinical remission as a treatment
target to change the trajectory of severe asthma
care.
Fasenra
Event
|
|
|
Commentary
|
Phase III data readout
|
MANDARA
|
|
Positive high-level results from the MANDARA Phase III trial
for Fasenra demonstrated non-inferior rates of remission
compared to mepolizumab in patients with EGPA who were receiving
oral corticosteroids with or without stable immunosuppressive
therapy. MANDARA was the first head-to-head trial of biologics in
EGPA, comparing a single monthly injection
of Fasenra to three injections per month of
mepolizumab, the only currently approved treatment. (September
2023)
|
Presentation: ERS
|
SHAMAL
|
|
SHAMAL assessed the ability of Fasenra to
permit a progressive reduction from high-dose ICS/LABA down to
anti-inflammatory reliever whilst maintaining control in
SEA[79] pts
who were well-controlled on Fasenra. Fasenra enabled
the majority of SEA patients to maintain disease control and remain
exacerbation-free despite a reduction in background therapy to
anti-inflammatory reliever only. (September
2023)
|
Presentation: ERS
|
MIRACLE
|
|
The positive MIRACLE Phase III trial demonstrated a reduction in
annual asthma exacerbation rate of 74% among patients in China with
uncontrolled SEA vs. placebo. A filing for regulatory approval in
China has been submitted, with a decision expected in H2 2024.
(September 2023)
|
Tezspire
Event
|
|
|
Commentary
|
Presentation: ERS
|
DESTINATION
|
|
In a post-hoc exploratory analysis of the DESTINATION Phase III
trial of patients with severe, uncontrolled asthma, a numerically
greater proportion of patients who received tezepelumab than
placebo achieved remission during the time periods assessed.
(September 2023)
|
|
|
BioPharmaceuticals - V&I
AZD3152
Event
|
|
|
Commentary
|
Presentation:ID Week
|
In-vitro neutralisation data
|
|
In vitro neutralisation
data presented at ID Week showed that AZD3152 potently neutralises
across a broad range of historical and contemporary SARS-CoV-2
variants, including the newly emerging BA.2.86 variant. AZD3152
loses activity against XBB variants with the F456L mutation.
(October 2023)
The SUPERNOVA Phase III efficacy trial, which is now fully
enrolled, will assess the potential benefit of AZD3152 in
protecting immunocompromised patients in an environment with many
variants in circulation.
|
|
|
FluMist
Event
|
|
|
Commentary
|
sBLA
submission
|
Self administration
|
|
The FDA has accepted for review a sBLA for the approval of a self-
or caregiver-administered option for FluMist. If approved, FluMist will be the first flu vaccine available to
be self-administered by eligible patients or administered by
caregivers. The sBLA is supported by a usability study which
confirmed that individuals over 18 years of age could
self-administer or administer FluMist to eligible patients 2-49 years of age when
given instructions for use without any additional guidance.
(October 2023)
|
Rare Disease
Alexion, AstraZeneca Rare Disease presented new real-world and
clinical data at the European Committee for Treatment and Research
in Multiple Sclerosis and Americas Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS-ACTRIMS), offering further
evidence to support the established safety and efficacy
of Soliris and Ultomiris in treating NMOSD.
Alexion,
AstraZeneca Rare Disease presented new clinical data at the
American Society of Nephrology (ASN) for Ultomiris in IgAN[80] as
well as real-world data in aHUS.
Alexion,
AstraZeneca Rare Disease
presented new real-world and clinical data at the American
Association of Neuromuscular & Electrodiagnostic Medicine
(AANEM) Annual Meeting and Myasthenia Gravis Foundation of America
Scientific Session (MGFA SS). Data shared across 13 abstracts,
reinforcing the safety and efficacy of C5 inhibition in treating
generalized myasthenia gravis (gMG).
Soliris
Event
|
|
|
Commentary
|
Approval
|
Japan
|
|
Paediatric patients with gMG. (August 2023)
|
Approval
|
China
|
|
Adults with anti- aquaporin-4 antibody-positive NMOSD. (October
2023)
|
Ultomiris
Event
|
|
|
Commentary
|
CRL
|
US
|
|
The US FDA issued a CRL[81] regarding
the sBLA[82] for Ultomiris for
the treatment of adults with NMOSD. The sBLA included data from the
CHAMPION-NMOSD Phase III trial, which met the primary endpoint with
a safety profile consistent with the known profile of the
medicine. The CRL requested modifications to enhance
the Ultomiris Risk
Evaluation and Mitigation Strategy to further validate patients'
meningococcal vaccination status or prophylactic administration of
antibiotics prior to treatment. (September
2023)
|
Presentation: ASN
|
SANCTUARY
Phase II
|
|
Ultomiris demonstrated clinically meaningful efficacy and proof-of-concept
as a potential treatment for IgAN, based on rapid and sustained
proteinuria reduction. (November 2023)
|
vemircopan
Event
|
|
|
Commentary
|
Termination
|
ACH228-110 Phase II
|
|
Trial discontinued due to lack of efficacy. Following an interim
analysis, vemircopan's ability to appropriately control
intravascular haemolysis was not adequately shown, due to
significantly increased rates of breakthrough haemolysis and high
levels of LDH[83].
No new safety findings were observed, and the safety profile of
vemircopan has been favourable to date. This decision does not
impact ongoing Phase II trials. (September
2023)
|
gefurulimab
Event
|
|
|
Commentary
|
Orphan Drug Designation
|
US
|
|
gefurulimab was granted orphan drug designation by the FDA for the
treatment of patients with gMG. (September 2023)
|
ALXN2220
Event
|
|
|
Commentary
|
Orphan Drug Designation
|
US
|
|
ALXN2220 was granted orphan drug designation by the FDA for the
treatment of patients with ATTR-CM[84].
(September 2023)
|
Interim
financial statements
Table 20: Condensed consolidated statement of comprehensive
income: 9M 2023
For the nine months ended 30 September
|
|
2023
|
2022
|
|
|
$m
|
$m
|
Total Revenue[85]
|
|
33,787
|
33,144
|
Product Sales
|
|
32,466
|
32,200
|
Alliance Revenue
|
|
1,004
|
504
|
Collaboration Revenue
|
|
317
|
440
|
Cost of sales
|
|
(5,960)
|
(9,491)
|
Gross profit
|
|
27,827
|
23,653
|
Distribution expense
|
|
(394)
|
(380)
|
Research and development expense
|
|
(7,862)
|
(7,137)
|
Selling, general and administrative expense
|
|
(13,845)
|
(13,798)
|
Other operating income and expense
|
|
1,233
|
325
|
Operating profit
|
|
6,959
|
2,663
|
Finance income
|
|
236
|
50
|
Finance expense
|
|
(1,181)
|
(986)
|
Share of after tax losses in associates and joint
ventures
|
|
(12)
|
(4)
|
Profit before tax
|
|
6,002
|
1,723
|
Taxation
|
|
(1,000)
|
668
|
Profit for the period
|
|
5,002
|
2,391
|
Other comprehensive income
|
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
|
Remeasurement of the defined benefit pension liability
|
|
(1)
|
1,283
|
Net gains/(losses) on equity investments measured at fair value
through other comprehensive income
|
|
45
|
(21)
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
|
5
|
1
|
Tax on items that will not be reclassified to profit or
loss
|
|
-
|
(291)
|
|
|
49
|
972
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
|
Foreign exchange arising on consolidation
|
|
(201)
|
(2,493)
|
Foreign exchange arising on designated liabilities in net
investment hedges
|
|
(63)
|
(321)
|
Fair value movements on cash flow hedges
|
|
62
|
(214)
|
Fair value movements on cash flow hedges transferred to profit and
loss
|
|
28
|
250
|
Fair value movements on derivatives designated in net investment
hedges
|
|
47
|
33
|
Costs of hedging
|
|
(3)
|
(11)
|
Tax on items that may be reclassified subsequently to profit or
loss
|
|
(7)
|
95
|
|
|
(137)
|
(2,661)
|
Other comprehensive loss, net of tax
|
|
(88)
|
(1,689)
|
Total comprehensive income for the period
|
|
4,914
|
702
|
Profit attributable to:
|
|
|
|
Owners of the Parent
|
|
4,995
|
2,387
|
Non-controlling interests
|
|
7
|
4
|
|
|
5,002
|
2,391
|
Total comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
|
4,907
|
701
|
Non-controlling interests
|
|
7
|
1
|
|
|
4,914
|
702
|
Basic earnings per $0.25 Ordinary Share
|
|
$3.22
|
$1.54
|
Diluted earnings per $0.25 Ordinary Share
|
|
$3.20
|
$1.53
|
Weighted average number of Ordinary Shares in issue
(millions)
|
|
1,549
|
1,548
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
|
1,560
|
1,560
|
Table 21: Condensed consolidated statement of comprehensive
income: Q3 2023
For the quarter ended 30 September
|
|
2023
|
2022
|
|
|
$m
|
$m
|
Total Revenue85
|
|
11,492
|
10,982
|
Product Sales
|
|
11,018
|
10,590
|
Alliance Revenue
|
|
377
|
214
|
Collaboration Revenue
|
|
97
|
178
|
Cost of sales
|
|
(2,095)
|
(2,982)
|
Gross profit
|
|
9,397
|
8,000
|
Distribution expense
|
|
(129)
|
(126)
|
Research and development expense
|
|
(2,584)
|
(2,458)
|
Selling, general and administrative expense
|
|
(4,800)
|
(4,277)
|
Other operating income and expense
|
|
70
|
106
|
Operating profit
|
|
1,954
|
1,245
|
Finance income
|
|
101
|
15
|
Finance expense
|
|
(392)
|
(339)
|
Share of after tax (losses)/profits in associates and joint
ventures
|
|
(11)
|
1
|
Profit before tax
|
|
1,652
|
922
|
Taxation
|
|
(274)
|
720
|
Profit for the period
|
|
1,378
|
1,642
|
Other comprehensive income
|
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
|
Remeasurement of the defined benefit pension liability
|
|
(8)
|
252
|
Net gains/(losses) on equity investments measured at fair value
through other comprehensive income
|
|
93
|
(9)
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
|
1
|
(1)
|
Tax on items that will not be reclassified to profit or
loss
|
|
5
|
(16)
|
|
|
91
|
226
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
|
Foreign exchange arising on consolidation
|
|
(306)
|
(1,167)
|
Foreign exchange arising on designated liabilities in net
investment hedges
|
|
38
|
(126)
|
Fair value movements on cash flow hedges
|
|
(27)
|
(76)
|
Fair value movements on cash flow hedges transferred to profit and
loss
|
|
99
|
119
|
Fair value movements on derivatives designated in net investment
hedges
|
|
7
|
(1)
|
Costs of hedging
|
|
(2)
|
2
|
Tax on items that may be reclassified subsequently to profit or
loss
|
|
(19)
|
49
|
|
|
(210)
|
(1,200)
|
Other comprehensive loss, net of tax
|
|
(119)
|
(974)
|
Total comprehensive income for the period
|
|
1,259
|
668
|
Profit attributable to:
|
|
|
|
Owners of the Parent
|
|
1,374
|
1,640
|
Non-controlling interests
|
|
4
|
2
|
|
|
1,378
|
1,642
|
Total comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
|
1,255
|
667
|
Non-controlling interests
|
|
4
|
1
|
|
|
1,259
|
668
|
Basic earnings per $0.25 Ordinary Share
|
|
$0.89
|
$1.06
|
Diluted earnings per $0.25 Ordinary Share
|
|
$0.88
|
$1.05
|
Weighted average number of Ordinary Shares in issue
(millions)
|
|
1,549
|
1,548
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
|
1,560
|
1,559
|
Table 22:
Condensed consolidated statement of financial
position
|
|
At 30 Sep
2023
|
At 31 Dec
2022
|
At 30 Sep
2022
|
|
|
$m
|
$m
|
$m
|
Assets
|
|
|
|
|
Non-current assets
|
|
|
|
|
Property, plant and equipment
|
|
8,723
|
8,507
|
8,352
|
Right-of-use assets
|
|
977
|
942
|
875
|
Goodwill
|
|
19,939
|
19,820
|
19,707
|
Intangible assets
|
|
37,687
|
39,307
|
39,585
|
Investments in associates and joint ventures
|
|
62
|
76
|
53
|
Other investments
|
|
1,228
|
1,066
|
1,049
|
Derivative financial instruments
|
|
151
|
74
|
112
|
Other receivables
|
|
761
|
835
|
792
|
Deferred tax assets
|
|
4,057
|
3,263
|
3,436
|
|
|
73,585
|
73,890
|
73,961
|
Current assets
|
|
|
|
|
Inventories
|
|
5,292
|
4,699
|
5,078
|
Trade and other receivables
|
|
11,300
|
10,521
|
9,336
|
Other investments
|
|
244
|
239
|
440
|
Derivative financial instruments
|
|
97
|
87
|
105
|
Intangible assets
|
|
-
|
-
|
82
|
Income tax receivable
|
|
697
|
731
|
725
|
Cash and cash equivalents
|
|
4,871
|
6,166
|
4,458
|
Assets held for sale
|
|
-
|
150
|
-
|
|
|
22,501
|
22,593
|
20,224
|
Total assets
|
|
96,086
|
96,483
|
94,185
|
Liabilities
|
|
|
|
|
Current liabilities
|
|
|
|
|
Interest-bearing loans and borrowings
|
|
(5,372)
|
(5,314)
|
(5,408)
|
Lease liabilities
|
|
(235)
|
(228)
|
(210)
|
Trade and other payables
|
|
(20,542)
|
(19,040)
|
(17,694)
|
Derivative financial instruments
|
|
(83)
|
(93)
|
(68)
|
Provisions
|
|
(1,193)
|
(722)
|
(377)
|
Income tax payable
|
|
(1,163)
|
(896)
|
(1,093)
|
|
|
(28,588)
|
(26,293)
|
(24,850)
|
Non-current liabilities
|
|
|
|
|
Interest-bearing loans and borrowings
|
|
(22,225)
|
(22,965)
|
(23,013)
|
Lease liabilities
|
|
(744)
|
(725)
|
(668)
|
Derivative financial instruments
|
|
(75)
|
(164)
|
(290)
|
Deferred tax liabilities
|
|
(2,752)
|
(2,944)
|
(3,479)
|
Retirement benefit obligations
|
|
(1,048)
|
(1,168)
|
(919)
|
Provisions
|
|
(1,189)
|
(896)
|
(930)
|
Other payables
|
|
(2,244)
|
(4,270)
|
(4,882)
|
|
|
(30,277)
|
(33,132)
|
(34,181)
|
Total liabilities
|
|
(58,865)
|
(59,425)
|
(59,031)
|
Net assets
|
|
37,221
|
37,058
|
35,154
|
Equity
|
|
|
|
|
Capital and reserves attributable to equity holders of the
Parent
|
|
|
|
|
Share capital
|
|
387
|
387
|
387
|
Share premium account
|
|
35,166
|
35,155
|
35,137
|
Other reserves
|
|
2,078
|
2,069
|
2,081
|
Retained earnings
|
|
(434)
|
(574)
|
(2,471)
|
|
|
37,197
|
37,037
|
35,134
|
Non-controlling interests
|
|
24
|
21
|
20
|
Total equity
|
|
37,221
|
37,058
|
35,154
|
Table 23: 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 2022
|
|
387
|
35,126
|
2,045
|
1,710
|
39,268
|
19
|
39,287
|
Profit for the period
|
|
-
|
-
|
-
|
2,387
|
2,387
|
4
|
2,391
|
Other comprehensive loss
|
|
-
|
-
|
-
|
(1,686)
|
(1,686)
|
(3)
|
(1,689)
|
Transfer to other reserves
|
|
-
|
-
|
36
|
(36)
|
-
|
-
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
-
|
-
|
(4,486)
|
(4,486)
|
-
|
(4,486)
|
Issue of Ordinary Shares
|
|
-
|
11
|
-
|
-
|
11
|
-
|
11
|
Share-based payments charge for the period
|
|
-
|
-
|
-
|
471
|
471
|
-
|
471
|
Settlement of share plan awards
|
|
-
|
-
|
-
|
(831)
|
(831)
|
-
|
(831)
|
Net movement
|
|
-
|
11
|
36
|
(4,181)
|
(4,134)
|
1
|
(4,133)
|
At 30 Sep 2022
|
|
387
|
35,137
|
2,081
|
(2,471)
|
35,134
|
20
|
35,154
|
|
|
|
|
|
|
|
|
|
At 1 Jan 2023
|
|
387
|
35,155
|
2,069
|
(574)
|
37,037
|
21
|
37,058
|
Profit for the period
|
|
-
|
-
|
-
|
4,995
|
4,995
|
7
|
5,002
|
Other comprehensive loss
|
|
-
|
-
|
-
|
(88)
|
(88)
|
-
|
(88)
|
Transfer to other reserves
|
|
-
|
-
|
9
|
(9)
|
-
|
-
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
-
|
-
|
(4,487)
|
(4,487)
|
-
|
(4,487)
|
Dividends paid to non-controlling interests
|
|
-
|
-
|
-
|
-
|
-
|
(4)
|
(4)
|
Issue of Ordinary Shares
|
|
-
|
11
|
-
|
-
|
11
|
-
|
11
|
Share-based payments charge for the period
|
|
-
|
-
|
-
|
429
|
429
|
-
|
429
|
Settlement of share plan awards
|
|
-
|
-
|
-
|
(700)
|
(700)
|
-
|
(700)
|
Net movement
|
|
-
|
11
|
9
|
140
|
160
|
3
|
163
|
At 30 Sep 2023
|
|
387
|
35,166
|
2,078
|
(434)
|
37,197
|
24
|
37,221
|
Table 24:
Condensed consolidated statement of cash flows
For the nine months ended 30 September
|
|
2023
|
2022
|
|
$m
|
$m
|
Cash flows from operating activities
|
|
|
|
Profit before tax
|
|
6,002
|
1,723
|
Finance income and expense
|
|
945
|
936
|
Share of after tax losses of associates and joint
ventures
|
|
12
|
4
|
Depreciation, amortisation and impairment
|
|
4,060
|
4,000
|
Decrease in working capital and short-term provisions
|
|
150
|
3,458
|
Gains on disposal of intangible assets
|
|
(247)
|
(88)
|
Fair value movements on contingent consideration arising from
business combinations
|
|
202
|
293
|
Non-cash
and other movements
|
|
(623)
|
(973)
|
Cash generated from operations
|
|
10,501
|
9,353
|
Interest paid
|
|
(826)
|
(608)
|
Tax paid
|
|
(1,710)
|
(1,335)
|
Net cash inflow from operating activities
|
|
7,965
|
7,410
|
Cash flows from investing activities
|
|
|
|
Acquisition of subsidiaries, net of cash acquired
|
|
(189)
|
-
|
Payments upon vesting of employee share awards attributable to
business combinations
|
|
(84)
|
(297)
|
Payment of contingent consideration from business
combinations
|
|
(610)
|
(570)
|
Purchase of property, plant and equipment
|
|
(836)
|
(719)
|
Disposal of property, plant and equipment
|
|
131
|
17
|
Purchase of intangible assets
|
|
(1,996)
|
(1,298)
|
Disposal of intangible assets
|
|
288
|
442
|
Movement in profit-participation liability
|
|
190
|
-
|
Purchase of non-current asset investments
|
|
(109)
|
(28)
|
Disposal of non-current asset investments
|
|
32
|
42
|
Movement in short-term investments, fixed deposits and other
investing instruments
|
|
(12)
|
(321)
|
Payments to associates and joint ventures
|
|
-
|
(5)
|
Interest received
|
|
208
|
26
|
Net cash outflow from investing activities
|
|
(2,987)
|
(2,711)
|
Net cash inflow before financing activities
|
|
4,978
|
4,699
|
Cash flows from financing activities
|
|
|
|
Proceeds from issue of share capital
|
|
12
|
11
|
Issue of loans and borrowings
|
|
3,816
|
-
|
Repayment of loans and borrowings
|
|
(4,655)
|
(1,261)
|
Dividends paid
|
|
(4,479)
|
(4,364)
|
Hedge contracts relating to dividend payments
|
|
(19)
|
(127)
|
Repayment of obligations under leases
|
|
(194)
|
(182)
|
Movement in short-term borrowings
|
|
110
|
378
|
Payment of Acerta Pharma share purchase liability
|
|
(867)
|
(920)
|
Net cash outflow from financing activities
|
|
(6,276)
|
(6,465)
|
Net decrease in Cash and cash equivalents in the
period
|
|
(1,298)
|
(1,766)
|
Cash and cash equivalents at the beginning of the
period
|
|
5,983
|
6,038
|
Exchange rate effects
|
|
(66)
|
(86)
|
Cash and cash equivalents at the end of the period
|
|
4,619
|
4,186
|
Cash and cash equivalents consist of:
|
|
|
|
Cash and cash equivalents
|
|
4,871
|
4,458
|
Overdrafts
|
|
(252)
|
(272)
|
|
|
4,619
|
4,186
|
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements
for the nine months ended 30 September 2023 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 nine months
ended 30 September 2023 were approved by the Board of Directors for
publication on 9 November 2023.
This results announcement does not constitute statutory accounts of
the Group within the meaning of sections
434(3) and 435(3) of the Companies Act 2006. The annual financial
statements of the Group for the year ended 31 December 2022 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 IFRSs 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 2022.
The comparative figures for the financial year ended 31 December
2022 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.
Alliance and Collaboration Revenues
Effective 1 January 2023, the Group has updated the presentation of
Total Revenue on the face of the Statement of Comprehensive Income
to include Alliance Revenue as a separate element to Collaboration
Revenue. Alliance Revenue, previously reported within Collaboration
Revenue, comprises income related to sales made by collaboration
partners, where AstraZeneca is entitled to a profit share, revenue
share or royalties, which are recurring in nature while the
collaboration arrangement remains in place. Alliance Revenue does
not include Product Sales where AstraZeneca is leading
commercialisation in a territory. Collaboration Revenue arising
from collaborative arrangements where the Group retains a
significant ongoing economic interest and receives upfront amounts
and event-triggered milestones, which arise from the licensing of
intellectual property, will continue to be reported as
Collaboration Revenue. In collaboration arrangements either
AstraZeneca or the collaborator acts as principal in sales to the
end customer. Where AstraZeneca acts as principal, we record 100%
of sales to the end customer within Product Sales. The revised
presentation reflects the increasing importance of income arising
from profit share arrangements where collaboration partners are
responsible for booking revenues in some or all
territories.
The comparative revenue reported in 9M 2023 relating to the nine
months to 30 September 2022 has been retrospectively adjusted to
reflect the new split of Total Revenue, resulting in Alliance
Revenue of $504m being reported for the nine months to 30 September
2022, however the combined total of Alliance Revenue and
Collaboration Revenue is equal to the previously reported
Collaboration Revenue total for the nine months to 30 September
2022.
Going concern
The Group has considerable financial resources available. As at 30
September 2023, the Group has $11.8bn in financial resources (Cash
and cash equivalent balances of $4.9bn and undrawn committed bank
facilities of $6.9bn available, of which $2.0bn of the facilities
are available until February 2025 and the other $4.9bn are
available until April 2026, with $5.6bn of borrowings due within
one year). These facilities contain no financial covenants and were
undrawn at 30 September 2023.
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 2022.
IAS 12 'Income Taxes'
On 25 May 2023, the IASB issued an amendment to IAS 12 'Income
Taxes' to clarify how the effects of the global minimum tax
framework should be accounted for and disclosed effective 1 January
2023. This was endorsed by the UK Endorsement Board on 19 July 2023
and has been adopted by the Company for 2023 reporting. The Company
is currently assessing the potential impact of these rules upon its
financial statements. The Company has applied the exception to
recognising and disclosing information about deferred tax assets
and liabilities related to Pillar 2 income taxes.
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 charges of $376m have been recorded against
intangible assets during the nine months ended 30 September 2023
(9M 2022: $44m net charge). Impairment charges in respect of
medicines in development were $359m (9M 2022: $61m net charge)
including the $244m impairment of the ALXN1840 intangible asset,
following decision to discontinue this development programme in
Wilson's disease. Impairment charges in respect of launched
medicines were $17m (9M 2022: $nil).
As previously disclosed, on 16 January 2023 AstraZeneca completed
the acquisition of Neogene Therapeutics Inc. (Neogene), a global
clinical-stage biotechnology company pioneering the discovery,
development and manufacturing of next-generation T-cell receptor
therapies (TCR-Ts). The purchase price allocation exercise has
completed, with the fair value of total consideration determined at
$267m. Intangible assets of $100m and goodwill of $158m were
recognised in the acquisition balance sheet, as well as a cash
outflow of $189m net of cash acquired. Future contingent
milestones-based and non-contingent consideration is payable to a
maximum of $120m. Neogene's results have been consolidated into the
Group's results from 16 January 2023.
The acquisition of CinCor completed on 24 February 2023, recorded
as an asset acquisition, with consideration and net assets acquired
of $1,268m, which included intangible assets acquired of $780m,
$424m of cash and cash equivalents, and $75m of marketable
securities. The Condensed consolidated statement of cash flows
includes a $1,204m payment for the intangible assets which is
presented net of the $424m cash and cash equivalents acquired
within Purchase of intangible assets, whilst the $75m increase in
marketable securities is presented within Movement in short-term
investments, fixed deposits and other investing instruments.
Contingent consideration of up to $496m could be paid on
achievement of regulatory milestones, and will be recognised when
the associated milestones are triggered.
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 2022. Net Debt
is a non-GAAP financial measure.
Table 25: Net
debt
|
|
At 1 Jan 2023
|
Cash flow
|
Acquisitions
|
Non-cash& other
|
Exchange movements
|
At 30 Sep 2023
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Non-current instalments of loans
|
|
(22,965)
|
(3,826)
|
-
|
4,592
|
(26)
|
(22,225)
|
Non-current instalments of leases
|
|
(725)
|
(1)
|
(6)
|
(23)
|
11
|
(744)
|
Total long-term debt
|
|
(23,690)
|
(3,827)
|
(6)
|
4,569
|
(15)
|
(22,969)
|
Current instalments of loans
|
|
(4,964)
|
4,655
|
-
|
(4,587)
|
39
|
(4,857)
|
Current instalments of leases
|
|
(228)
|
215
|
(2)
|
(230)
|
10
|
(235)
|
Bank collateral received
|
|
(89)
|
(95)
|
-
|
-
|
-
|
(184)
|
Other short-term borrowings excluding overdrafts
|
|
(78)
|
(15)
|
-
|
-
|
14
|
(79)
|
Overdrafts
|
|
(183)
|
(69)
|
-
|
-
|
-
|
(252)
|
Total current debt
|
|
(5,542)
|
4,691
|
(2)
|
(4,817)
|
63
|
(5,607)
|
Gross borrowings
|
|
(29,232)
|
864
|
(8)
|
(248)
|
48
|
(28,576)
|
Net derivative financial instruments
|
|
(96)
|
19
|
-
|
167
|
-
|
90
|
Net borrowings
|
|
(29,328)
|
883
|
(8)
|
(81)
|
48
|
(28,486)
|
Cash and cash equivalents
|
|
6,166
|
(1,229)
|
-
|
-
|
(66)
|
4,871
|
Other investments - current
|
|
239
|
12
|
-
|
-
|
(7)
|
244
|
Cash and investments
|
|
6,405
|
(1,217)
|
-
|
-
|
(73)
|
5,115
|
Net debt
|
|
(22,923)
|
(334)
|
(8)
|
(81)
|
(25)
|
(23,371)
|
Non-cash movements in the period include fair value adjustments
under IFRS 9 Financial Instruments.
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 September
2023 was $184m (31 December 2022: $89m) and the carrying value of
such cash collateral posted by the Group at 30 September 2023 was
$175m (31 December 2022: $162m).
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
$819m (31 December 2022: $1,646m), which is shown in current other
payables.
Net debt increased by $448m in the nine months to 30 September 2023
to $23,371m. Details of the committed undrawn bank facilities are
disclosed within the going concern section of Note 1.
During the quarter to 30 September 2023, Moody's upgraded the
Company's solicited long term credit rating from A3 to A2 and its
short term rating from P-2 to P-1. Standard and Poor's credit
ratings were unchanged (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 $281m at 30
September 2023 (31 December 2022: $186m) and for which fair value
gains of $17m have been recognised in the nine months ended 30
September 2023 (9M 2022: $50m). In the absence of specific market
data, these unlisted investments are held at fair value based on
the cost of investment and adjusting 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 nine months ended 30 September 2023 are Level 1 fair
value measurements, valued based on quoted prices in active
markets.
Financial instruments measured at fair value include $1,296m of
other investments, $3,551m held in money-market funds, $289m of
loans designated at fair value through profit or loss and $90m of
derivatives as at 30 September 2023. With the exception of
derivatives being Level 2 fair valued, certain equity investments
as described above and an equity warrant of $14m categorised as
Level 3, the aforementioned balances are Level 1 fair valued.
Financial instruments measured at amortised cost include $175m of
cash collateral pledged to counterparties. The total fair value of
interest-bearing loans and borrowings at 30 September 2023, which
have a carrying value of $28,576m in the Condensed consolidated
statement of financial position, was $26,576m.
As announced in April 2023, the contractual relationship between
AstraZeneca and Swedish Orphan Biovitrum AB (Sobi) relating to
future sales of Beyfortus (nirsevimab) in the US has been replaced by
a royalty relationship between Sanofi and Sobi. As a result, a
non-current other payable representing AstraZeneca's future
obligations to Sobi was eliminated from AstraZeneca's Statement of
Financial Position in the quarter to 30 June 2023, and AstraZeneca
recorded a gain of $712m in Core Other operating
income.
Table 26:
Financial instruments - contingent
consideration
|
|
Diabetes alliance
|
Other
|
Total
|
Total
|
|
|
$m
|
$m
|
$m
|
$m
|
At 1 January
|
|
2,124
|
98
|
2,222
|
2,865
|
Additions through business combinations
|
|
-
|
60
|
60
|
-
|
Settlements
|
|
(608)
|
(2)
|
(610)
|
(570)
|
Disposals
|
|
-
|
-
|
-
|
(121)
|
Revaluations
|
|
229
|
(27)
|
202
|
293
|
Discount unwind
|
|
93
|
6
|
99
|
126
|
At 30 September
|
|
1,838
|
135
|
1,973
|
2,593
|
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 $1,838m (31 December 2022:
$2,124m) would increase/decrease by $184m with an increase/decrease
in sales of 10%, as compared with the current
estimates.
Note 5: Pensions and other post-retirement benefit
obligations
During the nine months ended 30 September 2023, AstraZeneca
Pharmaceuticals PLP terminated its main defined benefit pension
plan. A total of $839m of pension obligations were discharged,
$142m of which was settled via a cash payment to the participants
and the remaining $697m was transferred to an external insurer via
a buy-out. At 30 September 2023, the plan contained immaterial
residual assets and obligations which are expected to be discharged
by the end of 2023, with minimal impact to the income
statement.
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 2022 and the Interim Financial Statements for
the six months ended 30 June 2023 (the Disclosures).
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.
Unless specifically identified below, AstraZeneca considers each of
the claims to represent a contingent liability or a contingent
asset where the matter is brought by AstraZeneca, and discloses
information with respect to the nature and facts of the cases in
accordance with IAS 37.
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 third quarter of 2023 and to 9
November 2023
Patent litigation
Legal proceedings brought against AZ 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
Pharmaceuticals LP 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 willfulness. 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 April 1, 2022 through November 4, 2024,
in addition to the past damages previously awarded by the
Court.
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, inter alia, 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, instituting 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 requested reconsideration of the
decision not to institute review of the patent. In February 2023,
the USPTO reinstituted the PGR proceeding. An oral hearing took
place in August 2023. The parties await a
decision.
Legal proceedings brought by AZ considered to be contingent
assets
Faslodex
Patent proceedings outside the US
In 2021 in Japan, AstraZeneca received notice from the Japan Patent
Office (JPO) that Sandoz K.K. (Sandoz) and Sun Pharma Japan Ltd.
(Sun) were seeking to invalidate the Faslodex formulation patent. AstraZeneca defended the
challenged patent, and Sun withdrew from the JPO patent challenge.
In July 2023, the JPO issued a final decision upholding various
claims of the challenged patent and determining that other patent
claims were invalid. In August 2023, Sandoz appealed the JPO
decision to the Japan IP High Court.
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. In its
complaint, AstraZeneca alleges that a generic version
of Calquence, if approved and marketed, would infringe patents
listed in the US FDA Orange Book with reference
to Calquence that are owned or licensed by AstraZeneca.
Trial has been scheduled for March 2025.
In February 2023, Sandoz Inc. filed a petition for inter partes
review with the US Patent and Trademark Office (USPTO) of
certain Calquence patent claims. AstraZeneca has asserted
claims for patent infringement against Sandoz and other defendants
in the US ANDA litigation. In August 2023, the Patent Trial and
Appeal Board issued a decision denying institution of inter partes
review.
Product liability litigation
Legal proceedings brought against AZ for which a provision has been
taken
Nexium and Losec/Prilosec
US proceedings
In the US, AstraZeneca is defending various lawsuits brought in
federal and state courts involving multiple plaintiffs claiming
that they have been diagnosed with various injuries following
treatment with proton pump inhibitors (PPIs),
including Nexium and Prilosec. The vast majority of those lawsuits related to
allegations of kidney injuries. In August 2017, the pending federal
court cases were consolidated in a multidistrict litigation (MDL)
proceeding in the US District Court for the District of New Jersey
for pre-trial purposes. A bellwether trial had been scheduled for
October 2023, with subsequent bellwether trials scheduled for
November 2023 and January 2024. In addition to the MDL cases, there
were cases filed in Delaware and New Jersey state
courts.
In addition, AstraZeneca has been defending lawsuits involving
allegations of gastric cancer following treatment with PPIs. One
such claim was filed in the US District Court for the Middle
District of Louisiana and is scheduled to go to trial in April
2024.
In October 2023, AstraZeneca resolved all pending claims in the
MDL, as well as all of the pending claims in Delaware and New
Jersey state courts, for $425m, for which a current provision has
been taken. A single case remains pending in the US District Court
for the Middle District of Louisiana.
Legal proceedings brought against AZ considered to be contingent
liabilities
Farxiga and Xigduo XR
US proceedings
In several jurisdictions in the US, AstraZeneca has been named as a
defendant in lawsuits involving plaintiffs claiming physical
injury, including Fournier's Gangrene and necrotising fasciitis,
from treatment with Farxiga and/or Xigduo XR. A majority of these claims are filed in Delaware
state court and remain pending. In September of 2023, the parties
resolved by settlement one case, filed in state court in Minnesota,
previously scheduled for trial in October 2023.
Commercial litigation
Legal proceedings brought against AZ for which a provision has been
taken
Alexion Shareholder Litigation (US)
In December 2016, putative securities class action lawsuits were
filed in the US District Court for the District of Connecticut (the
District Court) against Alexion and certain officers and directors,
on behalf of purchasers of Alexion publicly traded securities
during the period 30 January 2014 through 26 May 2017. The amended
complaint alleges that defendants engaged in securities fraud,
including by making misrepresentations and omissions in its public
disclosures concerning Alexion's Soliris sales practices, management changes, and
related investigations. In August 2021, the District Court issued a
decision denying in part Defendants' motion to dismiss the matter.
The Court granted plaintiffs' motion for class certification in
April 2023. In August 2023, the parties reached a settlement in
principle of this matter. In September 2023, the court granted
preliminary approval of the class settlement. The court scheduled a
hearing in December 2023 to rule on final approval. A provision has
been recognised in the quarter.
Legal proceedings brought by AZ considered to be contingent
assets
US 340B litigations and proceedings
US proceedings
AstraZeneca has been involved in several matters relating to its
contract pharmacy recognition policy under the 340B Drug Pricing
Program in the US.
In August 2023, AstraZeneca filed a lawsuit against the Attorney
General of the State of Louisiana alleging that the Louisiana's
340B statute, which requires manufacturers to recognize an
unlimited number of contract pharmacies, is preempted on several
grounds and violates the Contracts Clause of the U.S.
Constitution.
In September 2023, the Arkansas Insurance Department sent
AstraZeneca an administrative complaint concerning compliance with
Arkansas's 340B Statute, which requires manufacturers to recognize
an unlimited number of contract pharmacies. AstraZeneca response is
due in November 2023.
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in the US District
Court for the District of Delaware challenging aspects of the drug
price negotiation provisions of the Inflation Reduction Act and the
implementing guidance and regulations promulgated by the Department
of Health and Human Services.
Government investigations/proceedings
Legal proceedings brought against AZ 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 United States
District Court for Central District of California. The complaint
alleges that AstraZeneca violated the False Claims Act and
State-Law Counterparts. In September 2023, AstraZeneca filed a
motion to dismiss the relator's claims.
Subsequent events
In November, AstraZeneca announced a collaboration and investment
agreement with Cellectis, a clinical-stage biotechnology company,
to accelerate the development of next generation therapeutics in
areas of high unmet need, including oncology, immunology and rare
diseases. In Q4 2023, under the terms of the collaboration
agreement, Cellectis will receive an initial payment of $105m from
AstraZeneca, which comprises a $25m upfront cash payment and an
$80m equity investment. AstraZeneca expects to treat its investment
in Cellectis as an associate.
In November, AstraZeneca and Eccogene entered into an exclusive
licence agreement for ECC5004, an investigational oral once-daily
GLP-1RA for the treatment of obesity, type-2 diabetes and other
cardiometabolic conditions. Under the terms of the agreement,
AstraZeneca obtained exclusive global rights for development and
commercialisation in all territories except China where Eccogene
has the right to co-develop and co-commercialise alongside
AstraZeneca. Eccogene will receive an initial upfront payment of
$185m and up to an additional $1.825bn in future clinical,
regulatory, and commercial milestones and tiered
royalties.
Note 7
Table 27: 9M 2023 - Product Sales year-on-year
analysis[86]
|
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
|
12,692
|
17
|
20
|
5,652
|
20
|
2,925
|
7
|
15
|
2,428
|
19
|
19
|
1,687
|
18
|
28
|
Tagrisso
|
4,380
|
7
|
10
|
1,679
|
14
|
1,261
|
4
|
11
|
821
|
6
|
6
|
619
|
(4)
|
5
|
Imfinzi
|
3,102
|
53
|
56
|
1,708
|
55
|
270
|
20
|
31
|
547
|
36
|
35
|
577
|
90
|
n/m
|
Lynparza
|
2,070
|
6
|
9
|
902
|
1
|
409
|
14
|
24
|
543
|
10
|
10
|
216
|
7
|
16
|
Calquence
|
1,839
|
25
|
26
|
1,337
|
12
|
69
|
n/m
|
n/m
|
353
|
76
|
77
|
80
|
64
|
74
|
Enhertu
|
178
|
n/m
|
n/m
|
-
|
-
|
121
|
n/m
|
n/m
|
40
|
n/m
|
n/m
|
17
|
n/m
|
n/m
|
Orpathys
|
33
|
(3)
|
4
|
-
|
-
|
33
|
(3)
|
4
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex
|
699
|
(3)
|
5
|
12
|
9
|
521
|
3
|
11
|
98
|
(2)
|
(1)
|
68
|
(31)
|
(24)
|
Faslodex
|
217
|
(16)
|
(10)
|
9
|
(38)
|
113
|
(6)
|
-
|
22
|
(50)
|
(50)
|
73
|
(8)
|
-
|
Others
|
174
|
(36)
|
(32)
|
5
|
(36)
|
128
|
(38)
|
(34)
|
4
|
(41)
|
(40)
|
37
|
(29)
|
(22)
|
BioPharmaceuticals: CVRM
|
7,887
|
14
|
18
|
1,972
|
11
|
3,507
|
10
|
18
|
1,825
|
29
|
29
|
583
|
10
|
19
|
Farxiga
|
4,358
|
36
|
40
|
1,000
|
34
|
1,653
|
35
|
43
|
1,356
|
42
|
41
|
349
|
26
|
36
|
Brilinta
|
996
|
(2)
|
-
|
551
|
2
|
224
|
1
|
10
|
203
|
(5)
|
(5)
|
18
|
(54)
|
(51)
|
Lokelma
|
300
|
44
|
49
|
156
|
28
|
37
|
n/m
|
n/m
|
41
|
98
|
99
|
66
|
32
|
44
|
roxadustat
|
208
|
41
|
51
|
-
|
-
|
208
|
41
|
51
|
-
|
-
|
-
|
-
|
-
|
-
|
Andexxa
|
129
|
16
|
19
|
57
|
(8)
|
-
|
-
|
-
|
44
|
51
|
51
|
28
|
40
|
54
|
Crestor
|
860
|
4
|
11
|
40
|
(19)
|
678
|
8
|
15
|
41
|
38
|
38
|
101
|
(11)
|
(4)
|
Seloken/Toprol-XL
|
496
|
(30)
|
(23)
|
-
|
-
|
482
|
(30)
|
(24)
|
8
|
(19)
|
(19)
|
6
|
(18)
|
(13)
|
Onglyza
|
180
|
(12)
|
(8)
|
44
|
(26)
|
99
|
1
|
9
|
25
|
(17)
|
(17)
|
12
|
(30)
|
(27)
|
Bydureon
|
123
|
(40)
|
(40)
|
101
|
(43)
|
2
|
15
|
14
|
20
|
(30)
|
(30)
|
-
|
-
|
-
|
Others
|
237
|
(16)
|
(13)
|
23
|
(13)
|
124
|
(19)
|
(13)
|
87
|
(10)
|
(10)
|
3
|
(52)
|
(49)
|
BioPharmaceuticals: R&I
|
4,517
|
5
|
8
|
1,900
|
(3)
|
1,315
|
19
|
29
|
847
|
7
|
7
|
455
|
(1)
|
6
|
Symbicort
|
1,842
|
(4)
|
(1)
|
589
|
(18)
|
600
|
26
|
36
|
408
|
(8)
|
(8)
|
245
|
(12)
|
(7)
|
Fasenra
|
1,134
|
12
|
13
|
718
|
11
|
48
|
62
|
69
|
262
|
14
|
14
|
106
|
(1)
|
6
|
Breztri
|
478
|
69
|
73
|
263
|
60
|
123
|
73
|
86
|
55
|
n/m
|
n/m
|
37
|
48
|
58
|
Saphnelo
|
191
|
n/m
|
n/m
|
178
|
n/m
|
1
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
7
|
n/m
|
n/m
|
Tezspire
|
51
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
28
|
n/m
|
n/m
|
23
|
n/m
|
n/m
|
Pulmicort
|
493
|
3
|
10
|
22
|
(58)
|
392
|
16
|
24
|
49
|
(1)
|
-
|
30
|
(18)
|
(13)
|
Bevespi
|
42
|
(2)
|
(2)
|
24
|
(23)
|
5
|
21
|
32
|
12
|
70
|
70
|
1
|
59
|
10
|
Daliresp/Daxas
|
41
|
(74)
|
(74)
|
32
|
(79)
|
2
|
(23)
|
(10)
|
6
|
(9)
|
(9)
|
1
|
3
|
(25)
|
Others
|
245
|
(30)
|
(27)
|
74
|
(44)
|
144
|
(20)
|
(14)
|
22
|
(35)
|
(34)
|
5
|
(4)
|
2
|
BioPharmaceuticals: V&I
|
667
|
(82)
|
(81)
|
15
|
(98)
|
181
|
(82)
|
(81)
|
236
|
(66)
|
(66)
|
235
|
(76)
|
(73)
|
COVID-19 mAbs
|
126
|
(91)
|
(90)
|
-
|
n/m
|
5
|
(97)
|
(97)
|
7
|
(97)
|
(96)
|
114
|
(51)
|
(45)
|
Vaxzevria
|
28
|
(98)
|
(98)
|
-
|
n/m
|
18
|
(97)
|
(97)
|
10
|
(97)
|
(97)
|
-
|
n/m
|
n/m
|
Beyfortus
|
52
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
52
|
-
|
-
|
-
|
-
|
-
|
Synagis
|
383
|
-
|
6
|
(1)
|
n/m
|
158
|
9
|
15
|
109
|
(12)
|
(9)
|
117
|
2
|
11
|
FluMist
|
78
|
32
|
28
|
16
|
44
|
-
|
n/m
|
n/m
|
58
|
28
|
22
|
4
|
79
|
71
|
Rare Disease
|
5,793
|
11
|
12
|
3,469
|
9
|
487
|
54
|
68
|
1,165
|
8
|
8
|
672
|
1
|
9
|
Soliris
|
2,429
|
(17)
|
(15)
|
1,313
|
(22)
|
338
|
55
|
74
|
530
|
(15)
|
(15)
|
248
|
(36)
|
(31)
|
Ultomiris
|
2,141
|
56
|
58
|
1,260
|
63
|
47
|
38
|
39
|
495
|
43
|
42
|
339
|
54
|
68
|
Strensiq
|
847
|
23
|
24
|
690
|
26
|
29
|
14
|
16
|
64
|
9
|
8
|
64
|
12
|
22
|
Koselugo
|
246
|
65
|
65
|
144
|
26
|
49
|
n/m
|
n/m
|
38
|
n/m
|
n/m
|
15
|
n/m
|
n/m
|
Kanuma
|
130
|
17
|
18
|
62
|
11
|
24
|
53
|
55
|
38
|
13
|
12
|
6
|
4
|
12
|
Other medicines
|
910
|
(27)
|
(22)
|
104
|
(7)
|
580
|
(5)
|
3
|
67
|
(29)
|
(29)
|
159
|
(63)
|
(60)
|
Nexium
|
735
|
(25)
|
(20)
|
88
|
(6)
|
458
|
5
|
14
|
36
|
(1)
|
(2)
|
153
|
(63)
|
(60)
|
Others
|
175
|
(33)
|
(31)
|
16
|
(13)
|
122
|
(29)
|
(25)
|
31
|
(47)
|
(47)
|
6
|
(54)
|
(50)
|
Total Product Sales
|
32,466
|
1
|
4
|
13,112
|
3
|
8,995
|
1
|
8
|
6,568
|
7
|
7
|
3,791
|
(16)
|
(9)
|
Table 28: Q3 2023 - Product Sales year-on-year
analysis[87]
|
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
|
4,389
|
16
|
17
|
1,986
|
16
|
971
|
4
|
13
|
849
|
22
|
15
|
583
|
28
|
35
|
Tagrisso
|
1,465
|
5
|
6
|
577
|
11
|
409
|
1
|
8
|
281
|
5
|
(1)
|
198
|
(3)
|
2
|
Imfinzi
|
1,126
|
53
|
54
|
610
|
48
|
87
|
(4)
|
7
|
208
|
54
|
45
|
221
|
n/m
|
n/m
|
Lynparza
|
702
|
7
|
8
|
322
|
3
|
131
|
12
|
26
|
178
|
8
|
2
|
71
|
11
|
16
|
Calquence
|
654
|
16
|
15
|
468
|
2
|
28
|
n/m
|
n/m
|
128
|
63
|
54
|
30
|
65
|
72
|
Enhertu
|
73
|
n/m
|
n/m
|
-
|
-
|
48
|
n/m
|
n/m
|
16
|
n/m
|
n/m
|
9
|
n/m
|
n/m
|
Orpathys
|
12
|
6
|
13
|
-
|
-
|
12
|
6
|
13
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex
|
239
|
-
|
5
|
5
|
29
|
182
|
4
|
11
|
31
|
(1)
|
(6)
|
21
|
(29)
|
(25)
|
Faslodex
|
64
|
(21)
|
(16)
|
3
|
(41)
|
32
|
(19)
|
(13)
|
6
|
(53)
|
(55)
|
23
|
(5)
|
-
|
Others
|
54
|
(33)
|
(30)
|
1
|
(59)
|
42
|
(34)
|
(32)
|
1
|
11
|
11
|
10
|
(30)
|
(22)
|
BioPharmaceuticals: CVRM
|
2,683
|
14
|
16
|
690
|
9
|
1,161
|
7
|
15
|
657
|
40
|
32
|
175
|
6
|
10
|
Farxiga
|
1,554
|
41
|
41
|
366
|
31
|
579
|
41
|
48
|
506
|
54
|
45
|
103
|
24
|
29
|
Brilinta
|
331
|
(2)
|
(1)
|
193
|
4
|
64
|
(16)
|
(4)
|
68
|
4
|
(2)
|
6
|
(45)
|
(46)
|
Lokelma
|
102
|
30
|
31
|
51
|
15
|
13
|
39
|
48
|
16
|
97
|
87
|
22
|
31
|
38
|
roxadustat
|
74
|
31
|
39
|
-
|
-
|
74
|
30
|
39
|
-
|
-
|
-
|
-
|
-
|
-
|
Andexxa
|
40
|
(3)
|
(5)
|
20
|
-
|
-
|
-
|
-
|
15
|
32
|
20
|
5
|
(50)
|
(47)
|
Crestor
|
275
|
(1)
|
6
|
14
|
(10)
|
219
|
2
|
9
|
9
|
6
|
3
|
33
|
(11)
|
(7)
|
Seloken/Toprol-XL
|
153
|
(36)
|
(29)
|
-
|
-
|
149
|
(36)
|
(29)
|
2
|
(45)
|
(45)
|
2
|
(4)
|
(18)
|
Onglyza
|
53
|
(20)
|
(17)
|
9
|
(57)
|
33
|
-
|
9
|
8
|
(9)
|
(16)
|
3
|
(27)
|
(25)
|
Bydureon
|
35
|
(48)
|
(49)
|
28
|
(52)
|
1
|
97
|
90
|
6
|
(25)
|
(30)
|
-
|
-
|
-
|
Others
|
66
|
(23)
|
(21)
|
9
|
15
|
29
|
(40)
|
(37)
|
27
|
(1)
|
(2)
|
1
|
(42)
|
(39)
|
BioPharmaceuticals: R&I
|
1,451
|
2
|
3
|
609
|
(8)
|
422
|
14
|
23
|
266
|
9
|
2
|
154
|
3
|
7
|
Symbicort
|
555
|
(12)
|
(10)
|
156
|
(34)
|
195
|
15
|
24
|
123
|
(7)
|
(13)
|
81
|
(11)
|
(8)
|
Fasenra
|
389
|
10
|
10
|
249
|
9
|
19
|
56
|
67
|
86
|
12
|
5
|
35
|
1
|
4
|
Breztri
|
171
|
66
|
69
|
98
|
69
|
42
|
51
|
62
|
19
|
n/m
|
n/m
|
12
|
37
|
46
|
Saphnelo
|
76
|
n/m
|
n/m
|
71
|
n/m
|
-
|
-
|
-
|
2
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
Tezspire
|
21
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
11
|
n/m
|
n/m
|
10
|
n/m
|
n/m
|
Pulmicort
|
148
|
2
|
7
|
5
|
(69)
|
119
|
16
|
24
|
13
|
(11)
|
(16)
|
11
|
(8)
|
(5)
|
Bevespi
|
13
|
(5)
|
(4)
|
8
|
(23)
|
2
|
(2)
|
7
|
3
|
77
|
72
|
-
|
-
|
-
|
Daliresp/Daxas
|
11
|
(79)
|
(79)
|
8
|
(83)
|
-
|
(36)
|
(2)
|
2
|
(2)
|
(18)
|
1
|
n/m
|
-
|
Others
|
67
|
(31)
|
(28)
|
14
|
(55)
|
45
|
(20)
|
(14)
|
7
|
(14)
|
(19)
|
1
|
(7)
|
7
|
BioPharmaceuticals: V&I
|
224
|
(74)
|
(74)
|
15
|
(95)
|
32
|
(76)
|
(75)
|
122
|
(33)
|
(35)
|
55
|
(78)
|
(77)
|
COVID-19 mAbs
|
-
|
n/m
|
n/m
|
-
|
n/m
|
-
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
Vaxzevria
|
-
|
n/m
|
n/m
|
-
|
-
|
-
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
Beyfortus
|
50
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
50
|
-
|
-
|
-
|
-
|
-
|
Synagis
|
99
|
(5)
|
(1)
|
-
|
-
|
32
|
(13)
|
(7)
|
16
|
(4)
|
(10)
|
51
|
1
|
6
|
FluMist
|
75
|
28
|
23
|
15
|
41
|
-
|
-
|
-
|
56
|
22
|
16
|
4
|
81
|
76
|
Rare Disease
|
1,974
|
13
|
14
|
1,179
|
9
|
163
|
49
|
70
|
397
|
15
|
8
|
235
|
16
|
22
|
Soliris
|
781
|
(13)
|
(12)
|
420
|
(20)
|
124
|
47
|
71
|
163
|
(14)
|
(19)
|
74
|
(28)
|
(26)
|
Ultomiris
|
777
|
50
|
49
|
445
|
41
|
17
|
n/m
|
n/m
|
184
|
51
|
41
|
131
|
70
|
78
|
Strensiq
|
285
|
20
|
21
|
237
|
23
|
5
|
(32)
|
(10)
|
22
|
17
|
8
|
21
|
13
|
19
|
Koselugo
|
87
|
81
|
81
|
54
|
51
|
11
|
51
|
69
|
15
|
n/m
|
n/m
|
7
|
n/m
|
n/m
|
Kanuma
|
44
|
21
|
19
|
23
|
27
|
6
|
(4)
|
(2)
|
13
|
31
|
23
|
2
|
(10)
|
(5)
|
Other medicines
|
297
|
(27)
|
(22)
|
36
|
(3)
|
190
|
(11)
|
(4)
|
19
|
(32)
|
(34)
|
52
|
(59)
|
(56)
|
Nexium
|
244
|
(22)
|
(17)
|
29
|
(6)
|
153
|
3
|
13
|
11
|
5
|
(2)
|
51
|
(59)
|
(56)
|
Others
|
53
|
(43)
|
(41)
|
7
|
10
|
37
|
(44)
|
(41)
|
8
|
(54)
|
(53)
|
1
|
(66)
|
(57)
|
Total Product Sales
|
11,018
|
4
|
5
|
4,515
|
2
|
2,939
|
3
|
12
|
2,310
|
18
|
11
|
1,254
|
(7)
|
(3)
|
Table 29:
Alliance Revenue
|
|
9M 2023
|
9M 2022
|
|
|
$m
|
$m
|
Enhertu
|
|
741
|
335
|
Tezspire
|
|
179
|
42
|
Vaxzevria: royalties
|
|
-
|
67
|
Other royalty income
|
|
59
|
51
|
Other Alliance Revenue
|
|
25
|
9
|
Total
|
|
1,004
|
504
|
Table 30:
Collaboration Revenue
|
|
9M 2023
|
9M 2022
|
|
|
$m
|
$m
|
Lynparza: regulatory
milestones
|
|
-
|
250
|
COVID-19 mAbs: licence fees
|
|
180
|
-
|
Farxiga: sales
milestones
|
|
28
|
-
|
tralokinumab: sales milestones
|
|
20
|
110
|
Beyfortus: regulatory
milestones
|
|
71
|
-
|
Other Collaboration Revenue
|
|
18
|
80
|
Total
|
|
317
|
440
|
Table 31:
Other operating income and expense
|
|
9M 2023
|
9M 2022
|
|
|
$m
|
$m
|
brazikumab licence termination funding
|
|
75
|
104
|
Divestment of rights to Plendil
|
|
-
|
61
|
Divestment of US rights to Pulmicort Flexhaler
|
|
241
|
-
|
Update to the contractual relationships
for Beyfortus (nirsevimab)
|
|
712
|
-
|
Other
|
|
205
|
160
|
Total
|
|
1,233
|
325
|
Other shareholder information
Financial calendar
Announcement of full year and fourth quarter 2023 results: 8
February 2024
Dividends are normally paid as follows:
First interim:
Announced with the half year results and paid in
September
Second interim: Announced with full year
results and paid in March
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
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 Arimidex and Casodex,
owned by AstraZeneca or Juvisé (depending on
geography); Beyfortus, a trademark of Sanofi Pasteur
Inc.; Enhertu, a trademark of Daiichi Sankyo; Losec,
owned by AstraZeneca or Cheplapharm (depending upon
geography); 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
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 Twitter @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 our products
‒ the
risk of failure to achieve strategic plans or meet targets
or expectations
‒ 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
‒ the
risk of failure in financial control or the occurrence
of fraud
‒ the
risk of unexpected deterioration in the Group's
financial position
Nothing in this document, or any related presentation/webcast,
should be construed as a profit forecast.
- End of document -
[1] Constant exchange
rates. The differences between Actual Change and CER Change are due
to foreign exchange movements between periods in 2023 vs. 2022. CER
financial measures are not accounted for according to generally
accepted accounting principles (GAAP) because they remove the
effects of currency movements from Reported
results.
[2] Effective 1 January
2023, the Group has updated the presentation of Total Revenue. For
further details of the presentation of Alliance Revenue and
Collaboration Revenue, see the Basis of preparation and accounting
policies section of the Notes to the Interim financial statements
section.
[3] Reported financial
measures are the financial results presented in accordance with
UK-adopted International Accounting Standards and International
Financial Reporting Standards (IFRSs) as issued by the
International Accounting Standards Board (IASB) and International
Accounting Standards as adopted by the European
Union.
[4] Earnings per
share.
[5] Core financial
measures are adjusted to exclude certain items. The differences
between Reported and Core measures are primarily due to costs
relating to the acquisition of Alexion, amortisation of
intangibles, impairments, legal settlements and restructuring
charges. A full reconciliation between Reported EPS and Core EPS is
provided in Table 13 and Table 14 in the Financial performance
section of this document.
[6] The COVID-19 medicines
are Vaxzevria, Evusheld, and AZD3152 - the COVID-19 antibody currently in
development.
[7] Cardiovascular, Renal
and Metabolism.
[8] Respiratory &
Immunology.
[9] The calculation of
Reported and Core Product Sales Gross Margin (formerly termed as
Gross Margin) excludes the impact of Alliance Revenue and
Collaboration Revenue.
[10]Programmed cell death
protein 1/cytotoxic T-lymphocyte-associated protein
4.
[11]Glucagon-like peptide 1
receptor agonist.
[12] Hormone
receptor.
[13] Eosinophilic
granulomatosis with polyangiitis.
[14] Human epidermal growth
factor receptor 2.
[15] Relapsed or refractory
chronic lymphocytic leukaemia.
[16] Neuromyelitis optica
spectrum disorder.
[17] Epidermal growth factor
receptor mutation.
[18]Non-small cell lung
cancer.
[19]Vaccines & Immune
Therapies.
[20] In Table 2, the plus and
minus symbols denote the directional impact of the item being
discussed, e.g. a '+' symbol next to an R&D expense comment
indicates that the item increased the R&D expense relative to
the prior year.
[21] Cost of goods
sold.
[22]Income from disposals of
assets and businesses, where the Group does not retain a
significant ongoing economic interest, continue to be recorded in
Other operating income and expense in the Company's financial
statements.
[23] Metastatic
castration-resistant prostate cancer.
[24] Human epidermal growth
factor receptor mutant.
[25] Chronic lymphocytic
leukaemia.
[26] Heart failure with
preserved ejection fraction.
[27]Atypical haemolytic uraemic
syndrome.
[28] Paroxysmal nocturnal
haemoglobinuria.
[29] Programmed
death-ligand 1.
[30] Chronic kidney
disease.
[31] Chronic obstructive
pulmonary disease.
[32] Pressure metered
dose inhaler.
[33] Product Sales shown
in the Imfinzi line include Product Sales
from Imjudo.
[34] COVID-19 monoclonal
antibodies.
[35] National
reimbursement drug list.
[36] Biliary tract
cancer.
[37] Hepatocellular
carcinoma.
[38] Small cell lung
cancer.
[39] Poly ADP ribose
polymerase.
[40] Platinum sensitive
relapse.
[41] Breast cancer gene
mutation.
[42] Germline (hereditary)
breast cancer gene mutation.
[43] Bruton tyrosine
kinase inhibitor.
[44] Sodium-glucose
cotransporter 2.
[45] Type-2
diabetes.
[46] Heart failure with
reserved ejection fraction.
[47] European Society of
Cardiology.
[48] Fixed dose
combination.
[49] 'New-to-brand' share
represents a medicine's share in the dynamic
market.
[50] Inhaled
corticosteroid.
[51] Long-acting
beta-agonist.
[52] Respiratory syncytial
virus.
[53] Complement component
5.
[54] Generalised
myasthenia gravis.
[55] Other Operating
Income.
[56] Other adjustments
include fair-value adjustments relating to contingent consideration
on business combinations and other acquisition-related liabilities,
discount unwind on acquisition-related liabilities (see Note 4) and
provision movements related to certain legal matters, including a
$510m charge to provisions relating to a legal settlement with BMS
and Ono and a $425m charge to provisions relating to a
multidistrict litigation proceeding legal settlement in 9M 2023
(see Note 6).
[57] Other adjustments
include fair-value adjustments relating to contingent consideration
on business combinations and other acquisition-related liabilities,
discount unwind on acquisition-related liabilities (see Note 4) and
provision movements related to certain legal matters, including a
$425m charge to provisions relating to a multidistrict litigation
proceeding legal settlement in Q3 2023 (see Note
6).
[58] Securities Exchange
Commission.
[59] Based on best
prevailing assumptions around currency
profiles.
[60] Based on average
daily spot rates 1 Jan 2022 to 31 Dec 2022.
[61] Based on average
daily spot rates 1 Jan 2023 to 30 Sep 2023.
[62] Based on average
daily spot rates 1 Sep 2023 to 30 Sep 2023.
[63] Change vs. the
average spot rate for the previous year
[64] Other currencies
include AUD, BRL, CAD, KRW and RUB.
[65] Progression free
survival.
[66] Central nervous
system.
[67] Fluorouracil,
oxaliplatin and docetaxel .
[68] Pathologic complete
response.
[69] Gastro oesophageal
junction.
[70] Transarterial
chemoembolisation.
[71] Overall
survival.
[72] Immunohistochemistry.
[73] v-erb-b2 avian
erythroblastic leukemia viral oncogene homolog
2.
[74] Overall response
rate.
[75] Small lymphocytic
lymphoma.
[76] Antibody drug
conjugate.
[77] Heart
failure.
[78] Transthyretin-mediated amyloid
cardiomyopathy and transthyretin-mediated amyloid
polyneuropathy
[79] Severe eosinophilic
asthma.
[80] Immunoglobulin A
neuropathy.
[81] Compete Response
Letter.
[82] Supplemental
biologics license application.
[83] Lactic
dehydrogenase.
[84] Transthyretin-mediated amyloid
cardiomyopathy.
[85] Effective 1 January
2023, the Group has updated the presentation of Total Revenue. See
Note 1 for further details of the presentation of Alliance
Revenue.
[86] The table provides an
analysis of year-on-year Product Sales, with Actual and CER growth
rates reflecting year-on-year growth. Due to rounding, the sum of a
number of dollar values and percentages may not agree to
totals.
[87] The table provides an
analysis of year-on-year Product Sales, with Actual and CER growth
rates reflecting year-on-year growth. Due to rounding, the sum of a
number of dollar values and percentages may not agree to
totals.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date: 9
November 2023
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jul 2023 bis Jul 2024