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 February 2022
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZN: Full year and Q4 2021 results
AstraZeneca PLC
10 February 2022 07:00 GMT
Full year and Q4 2021 results
Total Revenue increased by 41% and Core EPS by 32% in a year of
exceptional pipeline and commercial delivery, coupled with
accelerated strategic transformation through the acquisition of
Alexion
●
Total Revenue increased 41% (38% at
CER1)
to $37,417m including COVID-19 vaccine revenues. Total Revenue
excluding vaccine increased 26% (23% at CER) to $33,436m. In Q4
2021, Total Revenue increased 62% (63% CER) to
$12,011m
●
Reported2 EPS3 of
$0.08 (FY 2020: $2.44) and Core4 EPS
of $5.29 (FY 2020: $4.02)
●
14 positive Phase III readouts across
nine medicines in 2021, and 22 regulatory approvals and
authorisations in major markets including five
NMEs5
●
FY 2022 guidance at CER of a
high-teens percentage increase in Total Revenue and a mid-to-high
twenties percentage increase in Core EPS
●
Reflecting increased confidence in
future growth and cash generation, the Board intends to increase
the annualised dividend by $0.10 to $2.90, and has approved a
second interim dividend for FY 2021 of $1.97, payable in March
2022. This results in a total dividend declared for FY 2021 of
$2.87
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"AstraZeneca continued on its strong growth trajectory in 2021,
with industry-leading R&D productivity, five of our medicines
crossing new blockbuster thresholds, and the acquisition and
integration of Alexion. We also delivered on our promise of broad
and equitable access to our COVID-19 vaccine with 2.5 billion doses
released for supply around the world, and we made good progress on
reducing our greenhouse gas emissions.
Growth was well balanced across our strategic areas of focus, and
we saw double-digit growth in all major regions, including Emerging
Markets despite some headwinds in China.
The positive news from our pipeline, including approvals
for Evusheld and Tezspire, supports the outlook for 2022. This, along
with the transformative acquisition of Alexion, means that we are
confident in our long term growth and profitability. After a
landmark year in 2021, we are increasing the dividend for our
shareholders."
Table 1: Revenue and EPS summary
|
|
|
FY 2021
|
|
|
Q4 2021
|
|
|
|
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
Change
|
change
|
$m
|
Change
|
change
|
- Product
Sales
|
|
36,541
|
41
|
38
|
11,498
|
64
|
65
|
- Collaboration
Revenue
|
|
876
|
20
|
20
|
513
|
29
|
29
|
Total
Revenue
|
|
37,417
|
41
|
38
|
12,011
|
62
|
63
|
Reported EPS
|
|
$0.08
|
(97)
|
(84)
|
$(0.22)
|
n/m6
|
n/m
|
Core
EPS
|
|
$5.29
|
32
|
37
|
$1.67
|
56
|
74
|
The differences between Reported and Core measures are primarily
due to items related to the acquisition of Alexion, amortisation of
intangibles, as well as impairments and restructuring charges, of
which $1,030m in the year related to the Group Review detailed
below. A full reconciliation between Reported EPS and Core EPS is
provided in Tables 17 and 18 in the Financial performance section
of this document. The differences between Actual Change and CER
Change are due to foreign exchange movements between corresponding
periods in 2021 vs 2020.
Key elements of Total Revenue performance in FY 2021
-
An increase in Product Sales of 41% (38% at CER) to
$36,541m
- Among AstraZeneca's
thirteen7 blockbuster
medicines in 2021, five medicines crossed new
thresholds: Tagrisso ($5bn+), Farxiga ($3bn+), Lynparza ($2bn+), Calquence ($1bn+) and Fasenra ($1bn+)
-
Following completion of the Alexion acquisition on 21 July 2021,
Rare Disease medicines generated 8% of AstraZeneca's FY 2021 Total
Revenue, growing 8% (9% CER) on a pro-rata basis to
$3,071m
- Growth of 19% (17% at CER) in
Oncology to $13,663m, 13% (9% at CER) in CVRM8 to
$8,034m, and 13% (9% at CER) in R&I9 to
$6,049m
- In the US, Total Revenue
increased by 38% to $12,228m. In Europe, Total Revenue increased by
45% (40% at CER) to $8,050m including Vaxzevria10 revenue
of $1,035m
- An increase in Emerging
Markets revenue of 41% (36% at CER) to $12,281m,
including Vaxzevria revenue of $2,304m. In China, Total Revenue
increased by 12% (4% CER) in the year to $6,011m. Pricing pressure
associated with NRDL11 and
VBP12 programmes
led to a decline in growth in the second half of the year, and in
Q4 2021 China Total
Revenue was 4% lower (8% at CER) than in Q4
2020
- Excluding vaccine revenue,
Total Revenue in ex-China Emerging Markets increased by 19% in the
year (21% at CER) to $3,977m and by 36% (38% at CER) in the quarter
to $1,197m, driven by Oncology medicines
and Farxiga
Post Alexion Acquisition Group Review
In conjunction with the acquisition of Alexion, the enlarged Group
initiated a comprehensive review across the organisation, aimed at
integrating systems, structure and processes, optimising the global
footprint and prioritising resource allocations and investments.
These activities are expected to be substantially complete by the
end of 2025, with a number of planned activities having commenced
in late 2021.
The identified activities, including those previously announced
regarding the integration of Alexion, are anticipated to incur
one-time restructuring costs of approximately $2.1bn, of which
approximately $1.4bn are cash costs and $0.7bn are non-cash costs,
and capital investments of approximately $0.2bn. The activities are
anticipated to realise run-rate pre-tax benefits, before
reinvestment, of approximately $1.2bn, including
previously-announced Alexion synergies, by the end of 2025. In line
with established practice, restructuring costs will be excluded
from our Core (non-GAAP) financial measures.
Guidance
The Company provides FY 2022 guidance at CER.
Total Revenue is expected to increase by a high teens
percentage
Core EPS is expected to increase by a mid-to-high twenties
percentage
- The CER growth rates
include the full-year contribution of Vaxzevria in
both FY 2021 and FY 2022
- Total Revenue from COVID-19
medicines is anticipated to decline by a low-to-mid twenties
percentage, with an expected decline in sales
of Vaxzevria being partially offset by growth
in Evusheld sales. The majority of vaccine revenue in
2022 is expected to come from initial contracts. The Gross Profit
Margin from the COVID-19 medicines is expected
to
be lower than the Company
average
-
Core Operating Expenses are expected to increase by a low-to-mid
teens percentage, driven in substantial part by the full year
integration of Alexion expenses
- Emerging Markets Total
Revenue, including China, is expected to grow mid-single-digits in
FY 2022. China Total Revenue is expected to decline by a
mid-single-digit percentage in FY 2022, primarily due to continued
NRDL and VBP programme impacting various medicines. The Company
remains confident in the longer term outlook for
Emerging
Markets, driven by a
large market opportunity, broader patient access and an increased
mix of new medicines
- A Core Tax Rate between
18-22%
AstraZeneca continues to recognise the heightened risks and
uncertainties from the effects of COVID-19. Variations in
performance between quarters can be expected to
continue.
The Company is unable to provide guidance on a Reported basis
because AstraZeneca cannot reliably forecast material elements of
the Reported result, 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 average foreign-exchange rates for January 2022 were seen over
the full year, it is anticipated that there would be a low
single-digit adverse impact on actual Total Revenue and Core EPS
versus the financials at CER. The Company's foreign-exchange rate
sensitivity analysis is shown in the Operating and financial
review.
Table 2: Key elements of financial performance
Metric
|
Reported
|
Reported change
|
Core
|
Corechange
|
|
Comments13
|
Total Revenue
|
$37,417m
|
41% increase (38% CER)
|
$37,417m
|
41% increase (38% CER)
|
|
See
Total Revenue commentary above
|
Gross Profit Margin14
|
66.0%
|
14 percentage point decline(13 at CER)
|
74.2%
|
6 percentage point decline(5 at CER)
|
|
+ Contribution
of Alexion
+ Increasing
mix of oncology sales
‒ Vaxzevria revenues
in 2021
‒ China
impact of NRDL and VBP
‒ Increasing
impact from profit-sharing arrangements
‒ Reported
impacted by unwind of Alexion inventory fair value
adjustment
|
R&D Expense
|
$9,736m
|
62% increase
(59% CER)
|
$7,987m
|
36% increase
(33% at CER)
|
|
+ Increased
investment in pipeline
+ COVID-19
medicines investment and pharmacovigilance
+ Addition
of Alexion R&D
+ 14
positive Phase III readouts in 2021
+ Reported
also impacted by $1,464m of impairments
|
SG&A Expense
|
$15,234m
|
35% increase
(32% at CER)
|
$11,104m
|
19% increase
(15% at CER)
|
|
+ Investments
in multiple launches
+ Addition
of Alexion
+ Expansion
in Emerging Markets
+ Reported
also impacted by amortisation related to Alexion acquisition, $338m
of restructuring and $603m of impairments
|
Other Operating Income15
|
$1,492m
|
2% decrease
(4% at CER)
|
$1,492m
|
3% decrease
(4% at CER)
|
|
= Divestment
gains at a similar level to FY 2020. See Table 38
|
Operating Margin
|
2.8%
|
17 percentage point decline(15 at CER)
|
26.5%
|
1 percentagepoint decline
(1 increase at CER)
|
|
See
Gross Margin and Expenses commentary above
|
Net Finance Expense
|
$1,257m
|
3% increase
(2% at CER)
|
$862m
|
10% increase
(11% at CER)
|
|
+ Alexion
debt financing costs
‒ Reported
impacted by lower discount unwind on acquisition-related
liabilities
|
Tax Rate
|
143%
|
n/m
|
17%
|
3 percentagepoint decrease
|
|
‒ Benefit
from non-taxable gain on the Viela equity
divestment
‒ Settlements
with tax authorities and expiry of statute of
limitations
|
EPS
|
$0.08
|
97% decrease
(84% at CER)
|
$5.29
|
32% increase
(37% at CER)
|
|
Further
details of differences between Reported and Core in Table
17
|
Table 3: Select medicines Total Revenue performance
Further details of the individual medicine performances are
provided in the Total Revenue section.
|
|
|
FY 2021
|
Q4 2021
|
|
|
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Tagrisso
|
Oncology
|
|
5,015
|
16
|
13
|
1,314
|
14
|
15
|
Imfinzi
|
|
|
2,412
|
18
|
16
|
634
|
14
|
15
|
Lynparza
|
|
|
2,748
|
23
|
21
|
1,029
|
25
|
26
|
Calquence
|
|
|
1,238
|
n/m
|
n/m
|
395
|
n/m
|
n/m
|
Enhertu
|
|
|
214
|
n/m
|
n/m
|
67
|
n/m
|
n/m
|
Farxiga
|
CVRM
|
|
3,005
|
53
|
49
|
849
|
45
|
46
|
Brilinta
|
|
|
1,472
|
(8)
|
(10)
|
348
|
(4)
|
(4)
|
Bydureon
|
|
|
385
|
(14)
|
(15)
|
91
|
(25)
|
(25)
|
Roxadustat
|
|
|
180
|
n/m
|
n/m
|
31
|
n/m
|
n/m
|
Lokelma
|
|
|
175
|
n/m
|
n/m
|
54
|
90
|
95
|
Symbicort
|
R&I
|
|
2,728
|
-
|
(2)
|
681
|
-
|
-
|
Fasenra
|
|
|
1,258
|
33
|
31
|
357
|
26
|
27
|
Pulmicort
|
|
|
962
|
(3)
|
(8)
|
248
|
(33)
|
(34)
|
Breztri
|
|
|
203
|
n/m
|
n/m
|
73
|
n/m
|
n/m
|
Soliris16
|
Rare
|
|
1,874
|
1
|
2
|
1,076
|
4
|
6
|
Ultomiris16
|
Disease16
|
|
688
|
27
|
29
|
391
|
24
|
26
|
Strensiq16
|
|
|
378
|
13
|
13
|
219
|
17
|
18
|
Vaxzevria
|
COVID-19
|
|
3,981
|
n/m
|
n/m
|
1,762
|
n/m
|
n/m
|
|
|
|
|
|
|
|
|
|
|
Table 4: Regional Total Revenue performance
Further details of the regional performances are provided in the
Regional Total Revenue section.
|
|
FY 2021
|
Q4 2021
|
|
|
|
% of
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
total
|
change
|
change
|
$m
|
change
|
change
|
Emerging Markets
|
|
12,281
|
33
|
41
|
36
|
3,663
|
63
|
61
|
|
US
|
|
12,228
|
33
|
38
|
38
|
3,923
|
64
|
64
|
|
Europe
|
|
8,050
|
22
|
45
|
40
|
2,872
|
57
|
58
|
|
Established Rest of World
|
|
4,858
|
13
|
37
|
37
|
1,553
|
64
|
72
|
|
Total
|
|
37,417
|
100
|
41
|
38
|
12,011
|
62
|
63
|
|
Total Revenue from Emerging Markets increased in the year by 41%
(36% CER) to $12,281m, of which $2,304m came
from Vaxzevria. Excluding Vaxzevria, Total Revenue from Emerging Markets increased by
15% (10% at CER) in the year to $9,977m.
Corporate and business development
In November 2021, AstraZeneca and Amgen Inc (Amgen) agreed to
include AZD8630 in the existing collaboration agreement between the
parties. AZD8630 is a human anti-TSLP Fab17 for
inhaled delivery and entered Phase I in Q1 2022. AZD8630 becomes
part of the collaboration with the companies sharing both costs and
income, with no inventor royalty. AstraZeneca will be the
development/regulatory lead, manufacturing lead, and commercial
lead. AstraZeneca and Amgen will jointly commercialise AZD8630 in
North America, and AstraZeneca will distribute the product and book
sales globally, including from the US. For commercialisation in the
US, Amgen will be responsible for commercial negotiations and
contracting (including to payer, pharmacy, pharmacy support
services), rebate processing and US government price
reporting.
In December 2021, AstraZeneca entered into a new global development
and commercialisation agreement with Ionis Pharmaceuticals, Inc.
(Ionis) for eplontersen, a ligand-conjugated antisense potential
new medicine currently in Phase III clinical trials for amyloid
transthyretin cardiomyopathy (ATTR-CM) and hereditary amyloid
transthyretin polyneuropathy (hATTR-PN). AstraZeneca paid Ionis an
upfront payment of $200m and will pay additional conditional
payments of up to $485m following regulatory approvals. The Company
will also pay up to $2.9bn of sales-related milestones based on
sales thresholds between $500m and $6bn, plus royalties in the
range of low double-digit to mid-twenties percentage depending on
the region.
In January 2022, AstraZeneca entered into an exclusive global
collaboration and licence agreement with Neurimmune AG for NI006,
an investigational human monoclonal antibody currently in
Phase Ib development for the treatment of ATTR-CM. Under the
agreement, Alexion will be granted an exclusive worldwide licence
to develop, manufacture and commercialise NI006. Alexion will pay
Neurimmune an upfront payment of $30m with the potential for
additional contingent milestone payments of up to $730m upon
achievement of certain development, regulatory and commercial
milestones, as well as low-to-mid teen royalties on net sales of
any approved medicine resulting from the
collaboration.
In January 2022, AstraZeneca completed the sale of the global
rights to Eklira (known as Tudorza in the US) and Duaklir to Covis Pharma GmbH for an upfront payment
of $270m, which will be recorded within Other Operating Income and
Expense. The intangible assets of $368m were held as Assets held
for sale as at 31 December 2021. In 2020, Eklira and Duaklir generated AstraZeneca revenue of $143m in
the countries covered by this agreement.
Sustainability summary
In line with our commitment to access to healthcare, in the fourth
quarter of 2021 the Company delivered approximately 102 million
doses of its COVID-19 vaccine through COVAX18.
As at the end of December 2021, the Company and its sublicensee
Serum Institute of India Pvt. Ltd. (SII) had delivered more than
247 million doses with COVAX to 130 countries. AstraZeneca and SII
remain the largest contributor to COVAX. As of February 2022,
AstraZeneca and its sub-licensing partners have released more than
2.6 billion vaccine doses for supply in over 180 countries, of
which approximately two thirds have gone to low and middle-income
countries.
The Company made good progress in reducing its Scope 1 and 2
greenhouse gas emissions. All imported electricity is now from
renewable sources. As at the end of December 2021, the Company had
achieved 59% reduction compared with its 2015 baseline. This
includes the full integration of Alexion's carbon footprint and
rebasing 2015. For further details, see the Sustainability
section
Notes
The following notes refer to pages one to five.
1.
Constant exchange rates. These are financial measures that are not
accounted for according to generally accepted accounting principles
(GAAP) because they remove the effects of currency movements from
Reported results.
2.
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
3.
Earnings per share.
4.
Core financial measures. These are non-GAAP financial measures
because, unlike Reported performance, they cannot be derived
directly from the information in the Group's Financial Statements.
See the Operating and financial review for a definition of Core
financial measures and a reconciliation of Core to Reported
financial measures.
5. New molecular entities. In FY 2021,
first major approvals were granted for Vaxzevria, Orpathys, Saphnelo, Evusheld and Tezspire.
6.
Not meaningful.
7. The thirteen medicines that
generated over a billion dollars of sales in calendar 2021
are Tagrisso, Vaxzevria, Farxiga, Symbicort, Imfinzi, Lynparza, Soliris, Brilinta, Nexium, Fasenra, Calquence,
Crestor and Ultomiris. This is based on Soliris and Ultomiris sales from 1 January 2021 to 31
December 2021.
8.
Cardiovascular, Renal & Metabolism.
9.
Respiratory & Immunology.
10. Vaxzevria is AstraZeneca's trademark for the Company's
supply of the AstraZeneca COVID-19 Vaccine. In the financial tables
in this report, 'Vaxzevria Product Sales' shows revenue recorded on the
Company's direct sales, and 'Vaxzevria Total Revenue' also includes Collaboration
Revenue from sub-licensees that produce and supply the AstraZeneca
COVID-19 Vaccine under their own trademarks.
11.
China's National Reimbursement Drug List.
12.
Volume-based procurement.
13.
The plus/minus signs in Table 2 align with the increase/decrease of
each metric, e.g. a comment about R&D Expenses which is
preceded by a plus sign discusses an item that increased the
R&D Expense compared to the previous year
14.
Gross Profit is defined as Total Revenue minus Cost of Sales. The
calculation of Reported and Core Gross Profit Margin excludes the
impact of Collaboration Revenue and any associated costs, thereby
reflecting the underlying performance of Product
Sales.
15.
Where AstraZeneca does not retain a significant ongoing interest in
medicines or potential new medicines, income from divestments is
reported within Reported and Core Other Operating Income and
Expense in the Company's financial statements.
16.
Year to date growth rates on Rare Disease medicines have been
calculated on a pro rata basis by comparing post-acquisition
revenues from 21 July 2021 to 31 December 2021 with the
corresponding period in the prior year, pre-acquisition as
previously published by Alexion. Q4 growth rates on Rare Disease
medicines have been calculated on a pro rata
basis
comparing to the corresponding period in the prior year,
pre-acquisition as previously published by Alexion. Pro rata Total
Revenue growth rates have been presented for FY 2021 and Q4
2021 Rare Disease area and constituent medicines, and do not impact
Group totals.
17.
Thymic stromal lymphopoietin fragment antigen-binding.
18.
COVID-19 Vaccines Global Access (COVAX) is a coalition co-led by
CEPI, the Coalition for Epidemic Preparedness Innovations, Gavi,
the Vaccine Alliance (Gavi), and the World Health Organisation
(WHO). It is the only global initiative bringing governments and
manufacturers together to ensure that safe and effective COVID-19
vaccines are available
worldwide
to both higher-income and lower-income
countries.
Upcoming pipeline news
The following table highlights developments in the late-stage
pipeline since the prior results announcement.
Table 5: Pipeline highlights
Event
|
Medicine
|
Indication / Trial
|
Event
|
Regulatory approvals
or other regulatory action
|
Saphnelo
|
Lupus (SLE[19])
|
CHMP[20] positive
opinion (EU)
|
Tezspire
|
Severe asthma
|
Approval (US)
|
Evusheld
|
COVID-19 prophylaxis
|
EUA (US)
|
Regulatory submissions, acceptances
|
Lynparza
|
Breast cancer (adjuvant, BRCAm[21])
|
Priority Review (US)
|
Lynparza
|
Breast cancer (adjuvant, BRCAm)
|
Regulatory submission (EU, JP)
|
Lynparza
|
Ovarian cancer (1st-line)
|
Regulatory submission (CN)
|
Lynparza
|
Prostate cancer (1st-line)
|
Regulatory submission (EU)
|
Enhertu
|
HER2+[22] breast
cancer (2nd-line)
|
Priority Review (US)
|
Enhertu
|
HER2+ breast cancer (2nd-line)
|
Regulatory submission (EU, JP)
|
Imfinzi +/-
tremelimumab
|
NSCLC[23] (1st-line)
|
Regulatory submission (US, EU, JP)
|
Koselugo
|
NF1-PN[24]
|
Regulatory submission (JP)
|
Ultomiris
|
Subcutaneous formulation in PNH[25]and
aHUS[26]
|
Regulatory submission (US)
|
Ultomiris
|
gMG[27]
|
Priority Review (US)
|
Major Phase III
data readouts, or
other significant developments
|
Vaxzevria /
AZD2816
|
COVID-19
|
Phase III primary endpoint met
|
Lynparza
|
Breast cancer (adjuvant, BRCAm)
|
Orphan Drug Designation (JP)
|
Lokelma
|
Chronic haemodialysis with hyperkalaemia
|
Fast Track Designation (US)
|
eplontersen
|
hATTR-PN[28] and
ATTR-CM[29]
|
Orphan Drug Designation (US)
|
Table 6: Pipeline anticipated major
news flow
Timing
|
Medicine
|
Indication / Trial
|
Event
|
|
Imfinzi
|
Biliary tract cancer (TOPAZ-1)
|
Regulatory submission
|
|
Imfinzi
|
NSCLC (1st-line) (PEARL)
|
Data readout
|
|
Imfinzi
|
Cervical cancer (CALLA)
|
Data readout
|
|
Imfinzi
|
NSCLC (unresectable, Stage III)(PACIFIC-2)
|
Data readout
|
|
Imfinzi +/-
tremelimumab
|
Liver cancer (1st-line) (HIMALAYA)
|
Regulatory submission
|
|
Lynparza
|
Breast cancer (adjuvant, BRCAm)
|
Regulatory decision (US)
|
|
Lynparza
|
Prostate cancer (1st-line)
|
Regulatory submission (US, JP)
|
|
Enhertu
|
Breast cancer (2nd-line, HER2+)
|
Regulatory decision (US)
|
|
Enhertu
|
Breast cancer (3rd-line, HER2-low)(DESTINY-Breast04)
|
Data readout, regulatory submission
|
|
Brilique
|
Stroke
|
Regulatory decision (CN)
|
H1 2022
|
Forxiga
|
Chronic kidney disease
|
Regulatory decision (CN)
|
|
Farxiga
|
HFpEF[30] (DELIVER)
|
Data readout
|
|
Fasenra
|
Nasal polyps
|
Regulatory decision (US)
|
|
Saphnelo
|
Lupus (SLE)
|
Regulatory decision (EU)
|
|
tezepelumab
|
Asthma
|
Regulatory decision (EU, JP)
|
|
PT027
|
Asthma
|
Regulatory submission (US)
|
|
Ultomiris
|
Subcutaneous formulation in PNH and aHUS
|
Regulatory submission (EU)
|
|
Ultomiris
|
NMOSD[31]
|
Data readout
|
|
Ultomiris
|
gMG
|
Regulatory decision (US)
|
|
Vaxzevria
|
COVID-19
|
Regulatory submission (US)
|
|
Evusheld
|
COVID-19 outpatient treatment
|
Regulatory submission (EU, JP)
|
|
nirsevimab
|
Respiratory syncytial virus
|
Regulatory submission
|
|
Tagrisso
|
NSCLC (adjuvant, EGFRm[32])
|
Regulatory decision (JP)
|
|
Imfinzi
|
NSCLC (unresectable, Stage III)
|
Regulatory submission
|
|
Imfinzi
|
NSCLC (1st-line)
|
Regulatory submission
|
|
Imfinzi
|
Cervical cancer
|
Regulatory submission
|
|
Imfinzi
|
Locoregional liver cancer (EMERALD-1)
|
Data readout, regulatory submission
|
H2 2022
|
Imfinzi
|
SCLC[33] (Limited-stage)
(ADRIATIC)
|
Data readout
|
|
Imfinzi +/-tremelimumab
|
NSCLC (1st-line)
|
Regulatory decision
|
|
Lynparza
|
Ovarian cancer (1st-line)
|
Regulatory decision (CN)
|
|
Lynparza
|
Prostate cancer (1st-line)
|
Regulatory decision (EU)
|
|
Lynparza
|
Breast cancer (adjuvant)
|
Regulatory decision (EU,JP)
|
|
Calquence
|
CLL[34]
|
Regulatory submission (JP)
|
|
Calquence
|
MCL[35] (1st-line)
(ECHO)
|
Data readout
|
|
Enhertu
|
Breast cancer (2nd-line, HER2+)
|
Regulatory decision (EU,JP)
|
|
Enhertu
|
Gastric cancer (2nd-line, HER2+)
|
Regulatory decision (EU)
|
|
Enhertu
|
Breast cancer (3rd-line, HER2+)(DESTINY-Breast02)
|
Data readout, regulatory submission
|
|
Farxiga
|
HFpEF
|
Regulatory submission
|
|
eplontersen
|
hATTR-PN (NEURO-TTRansform)
|
Data readout, regulatory submission
|
|
Fasenra
|
HES[36] (NATRON)
|
Data readout
|
H2 2022
|
Fasenra
|
EOE[37] (MESSINA)
|
Data readout
|
|
Ultomiris
|
Subcutaneous formulation in PNH and aHUS
|
Regulatory decision (US)
|
|
Ultomiris
|
gMG
|
Regulatory decision (EU,JP)
|
|
Ultomiris
|
NMOSD
|
Regulatory submission
|
|
ALXN1840
|
Wilson disease
|
Regulatory submission
|
|
acoramidis
|
ATTR-CM
|
Data readout
|
|
Koselugo
|
NF1-PN (SPRINT)
|
Regulatory submission (CN)
|
|
Koselugo
|
NF1-PN
|
Regulatory decision (JP)
|
|
Tagrisso
|
NSCLC (1st-line EGFRm) (FLAURA2)
|
Data readout, regulatory submission
|
|
Tagrisso
|
NSCLC (unresectable Stg. III, EGFRm) (LAURA)
|
Data readout, regulatory submission
|
|
Imfinzi
|
SCLC (Limited-stage)
|
Regulatory submission
|
|
Imfinzi
|
Bladder cancer (1st-line) (NILE)
|
Data readout, regulatory submission
|
|
Imfinzi
|
Bladder cancer (MI[38])
(NIAGARA)
|
Data readout, regulatory submission
|
|
Imfinzi
|
HCC[39] (adjuvant)
(EMERALD-2)
|
Data readout, regulatory submission
|
|
Imfinzi
|
NSCLC (Neoadjuvant) (AEGEAN)
|
Data readout, regulatory submission
|
|
Lynparza
|
Adjuvant breast cancer
|
Regulatory submission (CN)
|
2023
|
Lynparza
|
1st-line CRC[40] (LYNK-003)
|
Data readout, regulatory submission
|
|
Lynparza + Imfinzi
|
Ovarian cancer (1st-line) (DuO-O)
|
Data readout
|
|
Lynparza + Imfinzi
|
Endometrial cancer (1st-line) (DuO-E)
|
Data readout
|
|
Enhertu
|
Gastric cancer (HER2oe[41])(DESTINY-Gastric03)
|
Data readout
|
|
Enhertu
|
NSCLC (unresectable, HER2m) (DESTINY-Lung02)
|
Data readout
|
|
Enhertu
|
Breast cancer (2nd-line HER2-low) (DESTINY-Breast06)
|
Data readout
|
|
Calquence
|
CLL (Front line) (AC-CL-311)
|
Data readout
|
|
datopotamab deruxtecan
|
NSCLC (3rd-line) (TROPION-Lung01)
|
Data readout, regulatory submission
|
|
capivasertib
|
TNBC[42] (CAPitello-290)
|
Data readout, regulatory submission
|
|
capivasertib
|
Breast cancer (HR+/HER2-neg)(CAPitello-291)
|
Data readout, regulatory submission
|
|
camizestrant
|
HR+ HER2-neg BC (SERENA-6)
|
Data readout
|
|
Farxiga
|
Myocardial infarction (DAPA-MI)
|
Data readout
|
|
roxadustat
|
Anaemia in MDS[43]
|
Data readout
|
|
Fasenra
|
Eosinophilic oesophagitis
|
Regulatory submission
|
2023
|
Fasenra
|
EGPA[44]
(MANDARA)
|
Data readout, regulatory submission
|
|
Fasenra
|
Hyper-eosinophilic syndrome
|
Regulatory submission
|
|
Fasenra
|
Severe asthma (MIRACLE)
|
Data readout, regulatory submission (CN)
|
|
Fasenra
|
CRwNP[45] (ORCHID)
|
Data readout
|
|
Fasenra
|
Bullous pemphigoid (FJORD)
|
Data readout
|
|
Soliris
|
Guillain-Barre syndrome
|
Data readout (JP)
|
|
acoramidis
|
ATTR-CM
|
Data readout (JP)
|
|
danicopan
|
PNH with extravascular haemolysis
|
Data readout, regulatory submission
|
Conference call
A conference call and webcast for investors and analysts will begin
at 11:45 GMT. Details can be accessed via astrazeneca.com.
Reporting calendar
The Company intends to publish its first quarter results on 29
April 2022.
Reporting changes in FY 2022
From Q1 2022, AstraZeneca's Total Revenue and Product Sales tables
will include a new disease area: BioPharmaceuticals: Vaccines &
Immune Therapies (V&I). This will incorporate revenues
from Vaxzevria, Evusheld, FluMist, Synagis and nirsevimab. In the FY 2021
tables, Vaxzevria and Evusheld are shown under COVID-19,
and FluMist, Synagis and nirsevimab are shown under Other
medicines.
In addition, from Q1 2022 Koselugo will move from Oncology to Rare Disease,
and Andexxa will move from Rare Disease to
BioPharmaceuticals: CVRM.
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.
Contacts
For details on how to contact the Investor Relations Team,
please click
here. For Media
contacts, click
here
Operating and financial review
All narrative on growth and results in this section is based on
actual exchange rates, and financial figures are in US$ millions
($m), unless stated otherwise. The performance shown in this
announcement covers the twelve month period to 31 December 2021
('the year' or 'FY 2021') and the three month period to 31 December
2021 ('the quarter', 'the fourth quarter' or 'Q4 2021') compared to
the twelve month period to 31 December 2020 (FY 2020) and the three
month period to 31 December 2020 (Q4 2020) respectively, unless
stated otherwise.
Following the acquisition of Alexion, the Group has made a number
of changes to presented performance:
-
A new disease area, Rare Disease, presents the performance of
medicines acquired with Alexion
- The Group has ceased reporting
New Medicines as a performance metric (Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri). In line with practice these medicines will be
reported within their respective disease areas
- The Group has ceased reporting
New CVRM as a performance metric (Brilinta, Renal and Diabetes medicines). In line with
practice these medicines will be reported within the CVRM disease
area
Comparative performance relating to previous reporting periods will
be presented in line with the new presentation. This approach is
representative of the strategic priorities of the enlarged
Group.
Core financial measures, EBITDA, Net Debt, Initial Collaboration
Revenue and Ongoing Collaboration Revenue are non-GAAP financial
measures because they cannot be derived directly from the Group's
Condensed Consolidated Financial Statements. Management believes
that these non-GAAP financial measures, when provided in
combination with Reported results, provide investors and analysts
with helpful supplementary information to understand better the
financial performance and position of the Group on a comparable
basis from period to period. These non-GAAP financial measures are
not a substitute for, or superior to, financial measures prepared
in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant
items, 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
- Other
specified items, principally acquisition-related costs, which
include fair-value adjustments and the imputed finance charge
relating to contingent consideration on business combinations and
legal settlements
Details on the nature of Core financial measures are provided on
page 84 of the Annual Report and Form
20-F Information 2020.
Following the Alexion acquisition and in line with its policies,
the Group will exclude the following acquisition-related items in
the current and future periods from its Core
results:
-
The Group recognised significant additional intangible assets
reflecting the fair value of acquired launched medicines and
medicines in development. Future amortisation charges on these
assets will be excluded from the Group's Core results, similar to
the treatment of other intangible assets
-
The fair value of inventory acquired on completion was
significantly higher than historical cost. The adjustment to
increase the inventory to fair value is held in inventory until the
product is sold, at which time it is released to the Income
Statement in Cost of Sales. This results in a lower gross margin in
the first turn of inventory and this temporary
effect,
which
is expected over approximately 18 months post acquisition in line
with revenues, will be excluded from the Group's Core
results
-
The fair value of replacement employee share awards is higher than
both the value of the Alexion awards the employees were originally
granted and the expected value of future awards to those employees.
As a result, the Group will recognise an inflated expense during
the remaining vesting period of these awards. This temporary
increase in operating
expenses,
when compared with the expected expense based on the grant-date
value, will be excluded from the Group's Core
results
-
Other acquisition-related items to be excluded from the Group's
Core results include professional fees, retention bonuses included
in the acquisition agreement and the effect of unwinding other
acquisition-related fair value adjustments over time
Further details of these costs are included in Note 5, Acquisition
of Alexion. All the amounts above are presented in the 'Acquisition
of Alexion' column on the Reconciliation of Core to Reported
Financial Measures, except for intangible asset amortisation, which
is presented in the 'Intangible Asset Amortisation &
Impairments' column.
Reference should be made to the Reconciliation of Reported to Core
financial measures table included in the financial performance
section in this announcement.
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.
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
Condensed Financial Statements in this announcement.
Ongoing Collaboration Revenue is defined as Collaboration Revenue
excluding Initial Collaboration Revenue (which is defined as
Collaboration Revenue that is recognised at the date of completion
of an agreement or transaction, in respect of upfront
consideration). Ongoing Collaboration Revenue comprises, among
other items, royalties, milestone revenue and profit-sharing
income. Reference should be made to the Collaboration Revenue table
in this Operating and financial review.
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 may not agree to totals.
Total Revenue
The performance of the Company's medicines is shown below, with
more details available from Note 8 to the Condensed Financial
Statements.
Table 7: Total Revenue by disease area
|
|
FY 2021
|
Q4 2021
|
|
|
|
% of
|
Actual %
|
CER %
|
|
% of
|
Actual %
|
CER %
|
|
|
$m
|
Total
|
change
|
change
|
$m
|
total
|
change
|
change
|
Oncology
|
|
13,663
|
37
|
19
|
17
|
3,919
|
33
|
20
|
21
|
BioPharmaceuticals: CVRM
|
|
8,034
|
21
|
13
|
9
|
2,007
|
17
|
8
|
8
|
BioPharmaceuticals: R&I
|
|
6,049
|
16
|
13
|
9
|
1,593
|
13
|
4
|
3
|
Rare Disease16
|
|
3,071
|
8
|
8
|
9
|
1,760
|
15
|
10
|
11
|
Other medicines
|
|
2,484
|
7
|
(6)
|
(7)
|
835
|
7
|
12
|
14
|
COVID-19
|
|
4,116
|
11
|
n/m
|
n/m
|
1,897
|
16
|
n/m
|
n/m
|
Total Revenue
|
|
37,417
|
100
|
41
|
38
|
12,011
|
100
|
62
|
63
|
Table 8: Disease area and medicine performance
|
|
FY 2021
|
Q4 2021
|
|
|
$m
|
% of total
|
Actual % change
|
CER% change
|
$m
|
% of total
|
Actual % change
|
CER % change
|
Oncology
|
|
13,048
|
35
|
20
|
18
|
3,455
|
29
|
19
|
20
|
- Tagrisso
|
|
5,015
|
13
|
16
|
13
|
1,314
|
11
|
14
|
15
|
- Imfinzi
|
|
2,412
|
6
|
18
|
16
|
634
|
5
|
14
|
15
|
- Lynparza
|
|
2,348
|
6
|
32
|
30
|
629
|
5
|
27
|
28
|
- Calquence
|
|
1,238
|
3
|
n/m
|
n/m
|
395
|
3
|
n/m
|
n/m
|
- Koselugo
|
|
108
|
-
|
n/m
|
n/m
|
34
|
-
|
92
|
94
|
- Enhertu
|
|
17
|
-
|
n/m
|
n/m
|
7
|
-
|
n/m
|
n/m
|
- Orpathys
|
|
16
|
-
|
n/m
|
n/m
|
6
|
-
|
n/m
|
n/m
|
- Zoladex
|
|
948
|
3
|
7
|
3
|
232
|
2
|
7
|
7
|
- Faslodex
|
|
431
|
1
|
(26)
|
(27)
|
101
|
1
|
(22)
|
(21)
|
- Iressa
|
|
183
|
-
|
(32)
|
(35)
|
35
|
-
|
(49)
|
(47)
|
- Casodex
|
|
143
|
-
|
(17)
|
(21)
|
22
|
-
|
(43)
|
(42)
|
- Arimidex
|
|
139
|
-
|
(25)
|
(27)
|
33
|
-
|
(9)
|
(11)
|
- Others
|
|
50
|
-
|
1
|
(1)
|
13
|
-
|
3
|
5
|
BioPharmaceuticals: CVRM
|
|
8,020
|
21
|
13
|
10
|
2,003
|
17
|
9
|
9
|
- Farxiga
|
|
3,000
|
8
|
53
|
49
|
848
|
7
|
45
|
46
|
- Brilinta
|
|
1,472
|
4
|
(8)
|
(10)
|
348
|
3
|
(4)
|
(4)
|
- Bydureon
|
|
385
|
1
|
(14)
|
(15)
|
91
|
1
|
(25)
|
(25)
|
- Onglyza
|
|
360
|
1
|
(23)
|
(26)
|
75
|
1
|
(28)
|
(29)
|
- Byetta
|
|
55
|
-
|
(19)
|
(19)
|
10
|
-
|
(44)
|
(42)
|
- Other diabetes
|
|
59
|
-
|
26
|
24
|
17
|
-
|
34
|
34
|
- Lokelma
|
|
175
|
-
|
n/m
|
n/m
|
54
|
-
|
90
|
95
|
- Roxadustat
|
|
174
|
-
|
n/m
|
n/m
|
30
|
-
|
n/m
|
n/m
|
- Crestor
|
|
1,096
|
3
|
(7)
|
(10)
|
259
|
2
|
(13)
|
(13)
|
- Seloken/Toprol-XL
|
|
951
|
3
|
16
|
10
|
202
|
2
|
1
|
(2)
|
- Atacand
|
|
97
|
-
|
(60)
|
(60)
|
21
|
-
|
(67)
|
(67)
|
- Others
|
|
196
|
1
|
3
|
(2)
|
48
|
-
|
4
|
3
|
BioPharmaceuticals: R&I
|
|
6,034
|
16
|
13
|
9
|
1,590
|
13
|
4
|
4
|
- Symbicort
|
|
2,728
|
7
|
-
|
(2)
|
681
|
6
|
-
|
-
|
- Fasenra
|
|
1,258
|
3
|
33
|
31
|
357
|
3
|
26
|
27
|
- Pulmicort
|
|
962
|
3
|
(3)
|
(8)
|
248
|
2
|
(33)
|
(34)
|
- Daliresp
|
|
227
|
1
|
5
|
4
|
59
|
-
|
8
|
8
|
- Breztri
|
|
203
|
1
|
n/m
|
n/m
|
73
|
1
|
n/m
|
n/m
|
- Bevespi
|
|
54
|
-
|
12
|
12
|
15
|
-
|
24
|
26
|
- Saphnelo
|
|
8
|
-
|
n/m
|
n/m
|
7
|
-
|
n/m
|
n/m
|
- Others
|
|
594
|
2
|
49
|
42
|
150
|
1
|
20
|
18
|
Rare Disease16
|
|
3,070
|
8
|
8
|
9
|
1,759
|
15
|
10
|
11
|
- Soliris16
|
|
1,874
|
5
|
1
|
2
|
1,076
|
9
|
4
|
6
|
- Ultomiris16
|
|
688
|
2
|
27
|
29
|
391
|
3
|
24
|
26
|
- Strensiq16
|
|
378
|
1
|
13
|
13
|
219
|
2
|
17
|
18
|
- Andexxa16
|
|
68
|
-
|
(3)
|
(3)
|
39
|
-
|
-
|
(1)
|
- Kanuma16
|
|
62
|
-
|
20
|
21
|
34
|
-
|
16
|
17
|
Other medicines
|
|
2,367
|
6
|
(8)
|
(10)
|
825
|
7
|
13
|
15
|
- Nexium
|
|
1,326
|
4
|
(11)
|
(12)
|
328
|
3
|
(13)
|
(10)
|
- Synagis
|
|
410
|
1
|
10
|
13
|
239
|
2
|
n/m
|
n/m
|
- FluMist
|
|
253
|
1
|
(14)
|
(17)
|
178
|
1
|
(1)
|
(4)
|
- Losec/Prilosec
|
|
180
|
-
|
(2)
|
(7)
|
41
|
-
|
7
|
6
|
- Seroquel
XR/IR
|
|
92
|
-
|
(21)
|
(20)
|
19
|
-
|
(3)
|
(2)
|
- Others
|
|
106
|
-
|
(16)
|
(19)
|
20
|
-
|
(48)
|
(49)
|
COVID-19
|
|
4,002
|
11
|
n/m
|
n/m
|
1,866
|
16
|
n/m
|
n/m
|
- Vaxzevria
|
|
3,917
|
10
|
n/m
|
n/m
|
1,781
|
15
|
n/m
|
n/m
|
- Evusheld
|
|
85
|
-
|
n/m
|
n/m
|
85
|
1
|
n/m
|
n/m
|
Product Sales
|
|
36,541
|
98
|
41
|
38
|
11,498
|
96
|
64
|
65
|
Collaboration Revenue
|
|
876
|
2
|
20
|
20
|
513
|
4
|
29
|
29
|
Total Revenue
|
|
37,417
|
100
|
41
|
38
|
12,011
|
100
|
62
|
63
|
Table 9: Collaboration Revenue
|
|
FY 2021
|
Q4 2021
|
|
|
$m
|
% of total
|
Actual % change
|
CER % change
|
$m
|
% of total
|
Actual % change
|
CER % change
|
Lynparza: milestone
revenue
|
|
400
|
46
|
(13)
|
(13)
|
400
|
78
|
23
|
23
|
Enhertu: share of gross
profits
|
|
193
|
22
|
n/m
|
n/m
|
59
|
12
|
83
|
83
|
Roxadustat: share of gross profits
|
|
6
|
1
|
(81)
|
(83)
|
2
|
-
|
(87)
|
(87)
|
Other Collaboration Revenue
|
|
277
|
32
|
94
|
94
|
52
|
10
|
66
|
73
|
Total
|
|
876
|
100
|
20
|
20
|
513
|
100
|
29
|
29
|
Other Collaboration Revenue included contributions
from Movantik, Zoladex, Eklira, Duaklir,
Forxiga, Nexium OTC[46] and
other royalties, and a $100m receivable from
SII.
Total Revenue summary
Oncology
Total Revenue increased by 19% (17% at CER) in the year to $13,663m
and represented 37% of overall Total Revenue (FY 2020:
43%).
Tagrisso
Tagrisso has received
regulatory approval in 70 countries, including the US, China, and
in the EU, for use as an adjuvant treatment of EGFRm NSCLC
patients, with 19 reimbursements granted so far. This expands upon
the patient benefit from use in the 1st-line treatment of patients
with EGFRm NSCLC with regulatory approval in 94 countries,
including the US, China, in the EU and Japan. To date, 52
reimbursements have been granted in this setting, with further
decisions anticipated. These developments
followed Tagrisso's regulatory approval in 94 countries, including
the US, China, in the EU and Japan, to treat patients with EGFR
T790M[47] NSCLC,
an indication in which 68 reimbursements have been
granted.
Total Revenue, entirely comprising Product Sales, amounted to
$5,015m in the year and represented growth of 16% (13% at
CER).
Sales in the US increased by 14% in the year to $1,780m and
increased by 15% to $486m in Q4. Performance benefited from greater
1st-line and adjuvant use, with longer duration of treatment,
partially offset by lower 2nd-line use and a continued negative
impact on diagnosis, testing and treatment from the pandemic. After
a recovery during the second and third quarters of 2021, rates of
diagnosis and testing in lung and other cancers have declined as a
result of the latest wave of COVID-19 cases, and remained below
pre-pandemic levels at the end of the year.
Tagrisso sales in Emerging
Markets increased by 11% in the year (6% at CER) to $1,336m; the
performance was impacted by the admission of the medicine to the
China NRDL in March 2021 for the 1st-line setting and the renewal
in the 2nd-line setting. During the year, rising demand from
increased patient access in China almost completely offset the NRDL
price reduction. Emerging Markets sales in Q4 increased by 26% (23%
at CER) to $325m, driven by growth in both China and other Emerging
Markets.
Sales in Japan increased by 6% (8% at CER) to $775m in the year. In
Europe, sales of $986m in the year represented an increase of 32%
(25% at CER), driven by greater adoption in the 1st-line and
adjuvant settings, as more reimbursements were
granted.
Imfinzi
Imfinzi has received
regulatory approval in 75 countries, including the US, China, in
the EU, and Japan, with 35 reimbursements granted, to treat
patients with unresectable Stage III NSCLC, whose disease has not
progressed following platinum-based CRT[48]. Imfinzi has
also been approved to treat ES-SCLC[49] patients
in 67 countries, with nine reimbursements
granted.
Total Revenue, entirely comprising Product Sales, amounted to
$2,412m in the year and represented growth of 18% (16% at CER); the
performance reflected the increased use of Imfinzi to treat patients with ES-SCLC. US sales in
the year increased by 5% to $1,245m, despite the continued
COVID-19-related decrease in lung cancer diagnoses. In Q4 2021, US
sales grew by 10% to $330m. In Japan, sales of $345m represented
growth of 28% (30% at CER), where market share in ES-SCLC
increased. Europe sales increased by 31% (25% at CER) to $485m,
reflecting an increase in ES-SCLC market penetration and an
increase in the number of reimbursed markets. Sales in Emerging
Markets in the year increased to $277m, representing growth of 76%
(68% at CER). As a result of recent launches, Q4 2021 Emerging
Market sales grew by 47% (44% at CER) to $65m.
Lynparza
Lynparza has received
regulatory approvals in 89 countries for the treatment of ovarian
cancer; it has also been approved in 86 countries for the treatment
of metastatic breast cancer, and in 73 countries for the treatment
of pancreatic cancer. Lynparza has received regulatory approval in 74
countries for the 2nd-line treatment of certain prostate-cancer
patients.
Total Revenue amounted to $2,748m in the year representing growth
of 23% (21% at CER); this included Collaboration Revenue of $400m
comprising a sales milestone received in Q4 2021.
Product Sales in the year amounted to $2,348m, reflecting growth of
32% (30% at CER) and benefiting from further launches across
multiple cancer types globally. US Product Sales increased by 24%
to $1,087m in the year, due to growth in use in ovarian, breast and
prostate cancers. Lynparza remains the leading medicine in the
PARP[50] inhibitor
class globally across four tumour types, as measured by total
prescription volumes. Product Sales in Europe increased by 42% (35%
at CER) to $618m, reflecting additional reimbursements and
increasing BRCAm-testing rates, as well as successful 1st-line
BRCAm ovarian, 2nd-line HRRm[51] prostate
and germline BRCAm HER2-negative advanced breast cancer
launches.
Sales in Japan amounted to $199m, representing growth of 19% (21%
at CER). Emerging Markets Product Sales were $384m, up by 45% (41%
at CER), benefiting from increased patient access
to Lynparza following admission to the NRDL as a
1st-line treatment for BRCAm ovarian cancer patients with effect
from March 2021.
Enhertu
Total Revenue, predominately comprising Collaboration Revenue,
increased by 123% in the year to $214m.
Global in-market sales, excluding Japan, amounted to $426m in the
year (FY 2020: $202m). In Japan, AstraZeneca receives a
mid-single-digit percentage royalty on sales made by Daiichi Sankyo
Company Limited (Daiichi Sankyo). US in-market sales, recorded by
Daiichi Sankyo, amounted to $357m in the year (FY 2020: $200m) and
$105m in the quarter (Q4 2020: $64m).
Calquence
Calquence has received
regulatory approvals for the treatment of patients with CLL in 76
countries and in 37 countries for the treatment of patients with
R/R mantle cell lymphoma with reimbursement obtained in 25 and 13
countries, respectively.
Total Revenue, entirely comprising Product Sales, amounted to
$1,238m in the year and represented growth of 137% (136% at CER).
US sales increased by 113% in the year to $1,089m, representing the
majority of sales; a strong performance despite COVID-19 impacts on
CLL diagnosis rates, benefitting from increased new patient market
share. In Europe, sales amounted to $111m (FY 2020: $2m) through
increased market share in new patient starts after launches in the
region.
Koselugo
Total Revenue, comprising Product Sales predominately in the US,
amounted to $108m (FY 2020: $38m) in the year, following its launch
in the second quarter of 2020. Koselugo treats the rare disease NF1 in paediatric
patients aged two years and older who have symptomatic, inoperable
plexiform neurofibromas.
Orpathys
In June 2021, AstraZeneca and HUTCHMED's Orpathys was granted conditional approval in China to
treat patients with NSCLC with MET exon 14
skipping[52] alterations
that have progressed following prior systemic therapy or are unable
to receive chemotherapy. Total Revenue entirely comprising Product
Sales was $16m (FY 2020: $nil).
Zoladex
Total Revenue, predominantly comprising Product Sales, amounted to
$966m in the year and represented an increase of 3% (a decline of
1% at CER).
Emerging Markets sales of Zoladex increased by 10% (5% at CER) to $619m driven
by ex-China markets. In the US, revenue declined by 42% to $32m;
while in Europe, sales increased by 5% (a decline of 1% at CER) to
$147m. In Japan, sales increased by 7% (9% at CER) to
$139m.
Faslodex
Total Revenue, entirely comprising Product Sales, amounted to $431m
in the year and represented a decline of 26% (27% at CER) due to
increasing competition from several generic versions of the
medicine.
Emerging Markets sales decreased by 8% (10% at CER) to $167m, while
US sales declined by 46% to $30m, and in Europe, sales fell by 49%
(52% at CER) to $113m. In Japan, sales increased 1% (3% at CER) to
$118m.
Iressa
Total Revenue, entirely comprising Product Sales, amounted to $183m
in the year and represented a decline of 32% (35% at CER). Emerging
Markets sales fell by 31% (35% at CER) to $151m reflecting generic
competition and increasing patient access
to Tagrisso for 1st-line treatment in China, as a result
of NRDL changes.
BioPharmaceuticals: CVRM
Total Revenue increased by 13% (9% at CER) in the year, driven by
strong Farxiga performance, to $8,034m and represented 21%
of overall Total Revenue (FY 2020: 27%).
Farxiga
Total Revenue, predominantly comprising Product Sales, amounted to
$3,005m in the year and represented growth of 53% (49% at CER). The
performance of Farxiga continued to benefit from growth in the
SGLT2[53] inhibitor
class in many regions, with Farxiga volume growing faster than the overall SGLT2
market in most major regions.
Emerging Markets sales increased by 74% (70% at CER) to $1,195m in
the year, still benefitting from the addition
of Forxiga to the China NRDL in 2020. The initial price
impact has been more than offset by increased access for
patients. The NRDL status of Forxiga was renewed in the fourth quarter of
2021.
In the US, sales increased by 29% in the year to $732m, reflecting
the benefit of the regulatory approval in May 2020 for HFrEF and
the May 2021 approval for the treatment of CKD. Both approvals
include patients with and without T2D[54].
Sales in Europe increased by 60% (52% at CER) to $810m in the year.
The performance reflected SGLT2 inhibitor class growth, the
beneficial addition of CV outcomes trial data to the label, the
HFrEF regulatory approval in November 2020, and CKD regulatory
approval in August 2021. In Japan, sales to collaborator Ono
Pharmaceutical Co., Ltd, which records in-market sales, increased
by 33% (36% at CER) to $156m.
Brilinta
Total Revenue, entirely comprising Product Sales, amounted to
$1,472m in the year, representing a decrease of 8% (10% at CER).
Emerging Markets sales declined by 29% (31% at CER) to $328m,
reflecting the implementation of China's VBP programme in November
2020, resulting in significantly lower market access for the
medicine, and a mandatory price cut. In the US, sales increased by
1% to $735m partly reflecting the recent launch
of Brilinta as a treatment to reduce the risk of stroke
in patients following an acute ischaemic stroke or high-risk
transient ischaemic attack. However, US sales in the fourth quarter
declined by 9%, driven by managed markets in addition to the impact
from a new COVID-19 wave. Sales of Brilique in Europe increased by 1% in the year
(declined by 4% at CER) to $346m. The overall performance in the
year was adversely impacted by fewer elective procedures due to the
effects of the pandemic.
Onglyza
Total Revenue, entirely comprising Product Sales, amounted to $360m
in the year and represented a decline of 23% (26% at CER). Sales in
Emerging Markets decreased by 11% (14% at CER) to $179m. US sales
of Onglyza fell by 47% in the year to $88m as the
DPP-4[55] inhibitor
class continues to decline, whereas in Europe sales increased by 5%
(1% decrease at CER) to $61m.
Bydureon
Total Revenue, entirely comprising Product Sales, amounted to $385m
in the year, representing a decline of 14% (15% at CER). US sales
decreased by 16% in the year to $321m following the withdrawal of
the dual-chamber pen and lower demand for
the Bydureon BCise auto-injector device. Sales in Europe
increased by 5% (stable at CER) to $55m.
Lokelma
Total Revenue, entirely comprising Product Sales, amounted to $175m
in the year, representing an increase of 130%. Sales in the US
increased by 102% to $115m, reflecting the growth in the potassium
binder class. Lokelma continued to be the branded market share
leader.
In December 2021, the annual NRDL update was announced in
China. Lokelma was included on the NRDL from 1 January
2022. Sales in Japan increased to $43m in the year (FY 2020: $10m)
despite Ryotanki, a regulation that restricts prescriptions to two
weeks' supply in the first year of launch. The restriction was
lifted in June 2021 and no longer applies. During the period,
expansion in Europe continued with launches in several new markets;
sales in the region amounted to $13m (FY 2020:
$4m).
Roxadustat
Total Revenue in China, predominantly comprising Product Sales,
amounted to $180m in the year (FY 2020: $30m). Sales in the fourth
quarter were adversely impacted by stock compensation relating to
NRDL renewal. From January 2021, AstraZeneca started recognising
the overwhelming majority of China revenue as Product Sales
following an amendment in July 2020 to the existing licence
agreement with FibroGen, Inc.
Crestor
Total Revenue, primarily comprising Product Sales, amounted to
$1,098m in the year and represented a decline of 7% (10% at CER).
In Emerging Markets, sales increased by 4% (stable at CER) to
$775m, despite the adverse impact of China's VBP programme. US
sales declined by 13% to $80m, whereas in Europe, revenue decreased
by 59% (61% at CER) in the year to $54m following the February 2021
divestment of European rights in more than 30 countries to
Grünenthal GmbH (Grünenthal). In Japan, where AstraZeneca
collaborates with Shionogi Co., Ltd, sales declined by 8% (7% at
CER) to $151m.
BioPharmaceuticals: Respiratory & Immunology
Total Revenue, which included Ongoing Collaboration Revenue of $15m
from Duaklir, Eklira and other medicines, increased by 13% in the
year (9% at CER) to $6,049m and represented 16% of overall Total
Revenue (FY 2020: 20%). In January 2022, AstraZeneca completed the
transfer of global rights of Eklira and Duaklir to Covis Pharma GmbH.
Symbicort
Total Revenue, entirely comprising Product Sales, was stable at
$2,728m in the year (a decline of 2% at
CER). Symbicort remains the global market-volume and value
leader within the ICS[56]/LABA[57] class,
with market share performance driven by resilience in the US and
Europe, and growth in anti-inflammatory reliever launch markets.
The global ICS/LABA market was stable in the year, due to COVID-19
impacting diagnosis and treatment rates, while the market remained
resilient and showed signs of recovery in second half of
2021.
In the US, sales increased by 4% in the year to
$1,065m. Symbicort maintained total prescription market share
in a declining ICS/LABA market as fixed-dose triple
therapy (LAMA/LABA/ICS) launches continue.
Emerging Markets sales increased by 7% (4% at CER) to $609m, driven
by growth in markets outside China. In Europe, sales decreased by
3% (8% at CER) in the year to $670m, Symbicort maintained its share in a market that
declined year-on-year due to the favourable COVID-19 impact on FY
2020. Sales in Japan declined by 34% (33% at CER) to $124m in the
year due to continued generic competition.
Fasenra
Total Revenue, entirely comprising Product Sales, increased by 33%
(31% at CER) in the year to $1,258m as Fasenra expanded its leadership in eosinophilic
asthma. COVID-19 continues to impact total severe asthma market
growth with most regions experiencing a slowing in growth seen in
2020.
Sales in the US increased by 31% to $790m and in Europe by 41% (34%
at CER) to $286m for the year, both regions benefiting from growth
in new patient starts. Sales in Emerging Markets increased 67% to
$20m.
Pulmicort
Total Revenue, entirely comprising Product Sales, amounted to $962m
in the year and represented a decrease of 3% (8% at CER). In the
fourth quarter, sales were $248m representing a decrease of 33%
(34% at CER), largely as a result of the inclusion
of Pulmicort Respules in the latest round of VBP in China,
implemented in October 2021.
Emerging Markets, where Pulmicort sales decreased by 3% (9% at CER) in the
year to $770m, represented 80% of the global total. The
aforementioned VBP implementation in China resulted in
significantly lower market access for the medicine and a mandatory
price reduction. This impact was partially offset by growth in
Emerging Markets ex-China.
Sales in the US increased by 1% in the year to $72m. Europe sales
were stable year-on-year (a decline of 5% at CER) to $73m. In
Japan, sales decreased by 24% (22% at CER) in the year to $23m
following increasing generic competition.
Breztri
Breztri has received
regulatory approval in 39 countries, including the US, in the EU,
China, and Japan, to treat patients with COPD[58];
further regulatory reviews are ongoing. Breztri has achieved reimbursement in 24
countries.
Total Revenue, entirely comprising Product Sales, amounted to $203m
in the year (FY 2020: $28m). Sales in the US amounted to $115m (FY
2020: $5m), following market share growth in the fixed-dose triple
market. Emerging Markets sales amounted to $55m in the year (FY
2020: $14m). In China, Breztri is the market share leader within the
fixed-dose triple market, which continues to gain share from the
ICS/LABA class. Sales in Japan amounted to $25m (FY 2020: $9m). In
Europe, under the name Trixeo, sales amounted to $7m in the year (FY 2020:
$nil).
Saphnelo
Saphnelo has received
regulatory approval in the US and Japan to treat SLE. In December
2021, Saphnelo received positive recommendation in the EU
from the CHMP; other regulatory reviews are
ongoing.
Total Revenue, entirely comprising Product Sales in the US,
amounted to $8m in the year, following launch in at the end of Q3
2021.
Rare Disease
Total Revenue recorded post-acquisition from 21 July 2021, amounted
to $3,071m representing a pro rata increase of 8% (9% at CER) in
the period. Pro rata growth rates on Rare Disease medicines for the
year have been calculated by comparing post-acquisition revenues
from 21 July 2021 with the corresponding prior year pre-acquisition
revenues previously published by Alexion, adjusted pro rata to
match the post-acquisition period.
Soliris
Total Revenue in the year amounted to $1,874m, representing a pro
rata increase of 1% (2% at CER).
In the US, Total Revenue in the year amounted to
$1,068m, representing a pro rata increase of 4%. Sales
benefitted from growing use in neurology indications, gMG and
NMOSD, offset by the successful conversion
to Ultomiris in haematological indications PNH and
aHUS. Ultomiris offers patients a lower average annual
treatment cost, and a more convenient dosing schedule with every
eight week dosing versus the every two week regimen
for Soliris.
Outside of the US, Total Revenue amounted to $806m. Performance
during the period was driven by new country launches and benefitted
from order timing in the fourth quarter.
Ultomiris
Total Revenue in the year amounted to $688m, representing a pro
rata increase of 27% (29% at CER). Quarter on quarter variability
can be expected due to the every eight-week dosing
schedule.
In the US, Total Revenue in the year amounted to
$381m, representing a pro rata increase of 20%. Sales
benefitted from successful conversion from Soliris in PNH and aHUS.
Outside of the US, Total Revenue in the year amounted to
$307m. Performance was driven by new country launches in the
quarter.
Strensiq
Total Revenue in the year amounted to $378m, representing a
pro rata increase of 13%.
In the US, Total Revenue in the year amounted to $297m,
representing pro rata growth of 13%. Performance benefitted
increased demand over the course of the year as well as channel
inventory movements in the fourth quarter.
Other medicines (outside the main disease areas)
Total Revenue, primarily comprising Product Sales, amounted to
$2,484m in the year, a decrease of 6% (7% at CER). This does not
include revenue from Vaxzevria, which is covered in the COVID-19 commentary
below. Other medicines Total Revenue represented 7% of overall
Total Revenue (FY 2020: 10%).
Nexium
Total Revenue, predominantly comprising Product Sales, declined by
7% (8% at CER) in the year to $1,424m. Revenue in Emerging Markets
decreased by 7% (9% at CER) in the year to $705m, reflecting the
impact of the inclusion of Nexium (oral) in China's VBP programme in February
2021 resulting in significantly lower market access and a mandatory
price reduction. Nexium (i.v.) was included in the fifth round of
VBP with implementation in Q4 2021.
In Japan, where AstraZeneca collaborated with Daiichi Sankyo until
September 2021, Product Sales declined by 13% (11% at CER) in the
year to $369m. The quarterly phasing of sales in 2021 was impacted
by the phasing of orders from Daiichi Sankyo ahead of the
conclusion of the joint sales promotion by the two companies in
September 2021.
Total Revenue in the US declined by 20% to $150m, and in Europe, it
decreased by 17% (22% at CER) to $62m.
Synagis
Total Revenue, entirely comprising Product Sales, increased by 10%
in the year (13% at CER) to $410m. Sales in Q4 2021 increased by
207% (217% at CER) to $239m, following an increase in demand in the
northern hemisphere due to the earlier-than-usual
RSV[59] season
in 2021.
Sales in Europe declined by 38% (37% at CER) in the year to $203m.
This performance reflected the expiry of the ex-US commercial
rights agreement between AstraZeneca and AbbVie on 30 June 2021 and
changes as a result of the reversion of ex-US rights to AstraZeneca
thereafter. Prior to the expiry of the agreement, AstraZeneca's
sales to AbbVie were reported in Europe. In Q4 2021, AstraZeneca
recorded revenues in regions that, in the prior year, had been
covered by the aforementioned agreement, including sales in
Established Rest of World of $97m (Q4 2020: $nil) and sales in
Emerging Markets of $20m (Q4 2020: $nil).
FluMist
Total Revenue, entirely comprising of Product Sales, declined by
14% (17% at CER) to $253m in the year due to a one-off supplemental
order in the US in 2020 causing an unfavourable comparison to the
prior year. Sales in the US declined by 62% to $27m as a result.
Sales in Europe in the year increased 1% (declined 2% at CER) to
$222m.
COVID-19
Total Revenue of $4,116m included Collaboration Revenue of $114m,
of which $50m was recognised in Q4 2021 for an option agreement to
out-license commercial rights in certain limited geographies
for Evusheld, and $10m related to Collaboration Revenue
from a vaccine manufacturer in China.
Vaxzevria
Product Sales amounted to $3,917m in the year, with 963 million
doses of Vaxzevria invoiced worldwide by AstraZeneca. Over half
of sales, $2,240m, came from ex-China Emerging Markets. In Q4 2021,
Product Sales of $1,781m came from a blend of early pandemic
contracts and recent orders, and included $64m recognised as US
revenue for vaccine doses that were donated by the US Government to
other nations. In the year, the majority of doses delivered related
to pandemic contracts.
Evusheld
Product Sales contributed $85m, of which $66m came from Europe and
$19m from Emerging Markets. There were no Evusheld sales recorded in the US or Established Rest
of World.
Regional Total Revenue
A geographical split of Product Sales is shown in Note 8 to the
Condensed Financial Statements.
Table 10: Regional Total
Revenue
|
|
FY 2021
|
Q4 2021
|
|
|
|
% of
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
total
|
change
|
change
|
$m
|
change
|
change
|
Emerging Markets
|
|
12,281
|
33
|
41
|
36
|
3,663
|
63
|
61
|
- China
|
|
6,011
|
16
|
12
|
4
|
1,312
|
(4)
|
(8)
|
- Ex-China
|
|
6,270
|
17
|
88
|
89
|
2,351
|
n/m
|
n/m
|
US
|
|
12,228
|
33
|
38
|
38
|
3,923
|
64
|
64
|
Europe
|
|
8,050
|
22
|
45
|
40
|
2,872
|
57
|
58
|
Established RoW
|
|
4,858
|
13
|
37
|
37
|
1,553
|
64
|
72
|
- Japan
|
|
3,498
|
9
|
34
|
37
|
1,137
|
58
|
71
|
- Canada
|
|
772
|
2
|
28
|
19
|
236
|
62
|
54
|
- Other Established
RoW
|
|
588
|
2
|
90
|
76
|
180
|
n/m
|
n/m
|
Total
|
|
37,417
|
100
|
41
|
38
|
12,011
|
62
|
63
|
Table 11: Emerging Markets Total Revenue disease area
performance
|
|
FY 2021
|
Q4 2021
|
|
|
|
% of
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
total
|
change
|
change
|
$m
|
change
|
change
|
Oncology
|
|
3,223
|
26
|
11
|
6
|
785
|
18
|
15
|
BioPharmaceuticals: CVRM
|
|
3,785
|
31
|
17
|
12
|
869
|
10
|
8
|
BioPharmaceuticals: R&I
|
|
1,749
|
14
|
9
|
4
|
445
|
(19)
|
(21)
|
Rare Disease16
|
|
196
|
2
|
11
|
18
|
131
|
81
|
91
|
Other medicines
|
|
956
|
8
|
(1)
|
(4)
|
200
|
(17)
|
(18)
|
COVID-19
|
|
2,372
|
19
|
n/m
|
n/m
|
1,233
|
n/m
|
n/m
|
Total
|
|
12,281
|
100
|
41
|
36
|
3,663
|
63
|
61
|
Table 12: Ex-China Emerging Markets Total Revenue
|
|
FY 2021
|
Q4 2021
|
|
|
|
Actual %
|
CER %
|
|
Actual %
|
CER %
|
|
|
$m
|
change
|
change
|
$m
|
change
|
change
|
Ex-China Emerging Markets
|
|
6,270
|
88
|
89
|
2,351
|
n/m
|
n/m
|
- Russia
|
|
445
|
42
|
45
|
138
|
80
|
71
|
- Brazil
|
|
973
|
n/m
|
n/m
|
523
|
n/m
|
n/m
|
- Ex-Brazil Latin America
|
|
1,132
|
n/m
|
n/m
|
467
|
n/m
|
n/m
|
- Ex-China Asia Pacific
|
|
2,526
|
n/m
|
n/m
|
891
|
n/m
|
n/m
|
- Middle East and Africa
|
|
1,194
|
17
|
20
|
332
|
30
|
38
|
China Total Revenue comprised 49% of Emerging Markets Total Revenue
(FY 2020: 62%) and increased by 12% (4% at CER) in the year to
$6,011m.
Excluding Vaxzevria, Ex-China Emerging Markets Total Revenue
increased by 19% in the year (21% at CER) to
$3,977m.
Financial performance
Table 13: Reported Profit and Loss - FY 2021
|
|
FY 2021
|
FY 2020
|
Actual
|
CER
|
|
|
$m
|
$m
|
% change
|
% change
|
Total Revenue
|
|
37,417
|
26,617
|
41
|
38
|
- Product Sales
|
|
36,541
|
25,890
|
41
|
38
|
- Collaboration Revenue
|
|
876
|
727
|
20
|
20
|
Cost of
Sales
|
|
(12,437)
|
(5,299)
|
n/m
|
n/m
|
Gross Profit
|
|
24,980
|
21,318
|
17
|
17
|
Gross Profit Margin
|
|
66.0%
|
79.5%
|
-14
|
-13
|
Distribution
Expense
|
|
(446)
|
(399)
|
12
|
7
|
% Total Revenue
|
|
1.2%
|
1.5%
|
-
|
-
|
R&D
Expense
|
|
(9,736)
|
(5,991)
|
62
|
59
|
% Total Revenue
|
|
26.0%
|
22.5%
|
-4
|
-3
|
SG&A
Expense
|
|
(15,234)
|
(11,294)
|
35
|
32
|
% Total Revenue
|
|
40.7%
|
42.4%
|
+2
|
+2
|
Other
Operating Income & Expense
|
|
1,492
|
1,528
|
(2)
|
(4)
|
% Total Revenue
|
|
4.0%
|
5.7%
|
-2
|
-2
|
Operating Profit
|
|
1,056
|
5,162
|
(80)
|
(70)
|
Operating Margin
|
|
2.8%
|
19.4%
|
-17
|
-15
|
Net
Finance Expense
|
|
(1,257)
|
(1,219)
|
3
|
2
|
Joint
Ventures and Associates
|
|
(64)
|
(27)
|
n/m
|
n/m
|
(Loss)/Profit before tax
|
|
(265)
|
3,916
|
n/m
|
(93)
|
Taxation
|
|
380
|
(772)
|
n/m
|
n/m
|
Tax rate
|
|
143%
|
20%
|
|
|
Profit after tax
|
|
115
|
3,144
|
(96)
|
(83)
|
Earnings per share
|
|
$0.08
|
$2.44
|
(97)
|
(84)
|
Table 14: Reported Profit and Loss - Q4 2021
|
|
Q4 2021
|
Q4 2020
|
Actual
|
CER
|
|
|
$m
|
$m
|
% change
|
% change
|
Total Revenue
|
|
12,011
|
7,410
|
62
|
63
|
- Product Sales
|
|
11,498
|
7,011
|
64
|
65
|
- Collaboration Revenue
|
|
513
|
399
|
29
|
29
|
Cost of Sales
|
|
(4,625)
|
(1,525)
|
n/m
|
n/m
|
Gross Profit
|
|
7,386
|
5,885
|
25
|
31
|
Gross Profit Margin
|
|
59.8%
|
78.2%
|
-18
|
-16
|
Distribution Expense
|
|
(124)
|
(109)
|
14
|
13
|
% Total Revenue
|
|
1.0%
|
1.5%
|
-
|
-
|
R&D Expense
|
|
(2,584)
|
(1,719)
|
50
|
50
|
% Total Revenue
|
|
21.5%
|
23.2%
|
2
|
2
|
SG&A Expense
|
|
(5,117)
|
(3,210)
|
59
|
59
|
% Total Revenue
|
|
42.6%
|
43.3%
|
1
|
1
|
Other Operating Income & Expense
|
|
147
|
640
|
(77)
|
(78)
|
% Total Revenue
|
|
1.2%
|
8.6%
|
-7
|
-7
|
Operating (Loss)/Profit
|
|
(292)
|
1,487
|
n/m
|
n/m
|
Operating Margin
|
|
-2.4%
|
20.1%
|
-22
|
-20
|
Net Finance Expense
|
|
(335)
|
(314)
|
7
|
8
|
Joint Ventures and Associates
|
|
(9)
|
(6)
|
53
|
51
|
(Loss)/Profit Before Tax
|
|
(636)
|
1,167
|
n/m
|
n/m
|
Taxation
|
|
290
|
(162)
|
n/m
|
n/m
|
Tax rate
|
|
46%
|
14%
|
|
|
(Loss)/Profit After Tax
|
|
(346)
|
1,005
|
n/m
|
n/m
|
(Loss)/Earnings per share
|
|
$(0.22)
|
$0.78
|
n/m
|
n/m
|
Table 15: Reconciliation of Reported (Loss)/Profit Before Tax to
EBITDA - FY 2021
|
|
FY 2021
|
FY 2020
|
Actual
|
CER
|
|
|
$m
|
$m
|
% change
|
% change
|
Reported (Loss)/Profit Before Tax
|
|
(265)
|
3,916
|
n/m
|
(93)
|
Net Finance Expense
|
|
1,257
|
1,219
|
3
|
2
|
Joint Venture and Associates
|
|
64
|
27
|
n/m
|
n/m
|
Depreciation, Amortisation and Impairment
|
|
6,530
|
3,149
|
n/m
|
99
|
EBITDA
|
|
7,586
|
8,311
|
(9)
|
(6)
|
EBITDA of $7,586m in the year (FY 2020: $8,311m) has been
negatively impacted by the $2,198m (FY 2020: $nil) unwind of
inventory fair value uplift recognised on acquisition of Alexion,
as well as increased restructuring charges arising from the Post
Alexion Acquisition Group Review. The unwind of inventory fair
value is expected to depress EBITDA over approximately 18 months
post-acquisition in line with revenues.
Table 16: Reconciliation of Reported (Loss)/Profit Before Tax to
EBITDA - Q4 2021
|
|
Q4 2021
|
Q4 2020
|
Actual
|
CER
|
|
|
$m
|
$m
|
% change
|
% change
|
Reported (Loss)/Profit Before Tax
|
|
(636)
|
1,167
|
n/m
|
n/m
|
Net Finance Expense
|
|
335
|
314
|
7
|
8
|
Joint Venture and Associates
|
|
9
|
6
|
53
|
51
|
Depreciation, Amortisation and Impairment
|
|
2,192
|
797
|
n/m
|
n/m
|
EBITDA
|
|
1,900
|
2,284
|
(17)
|
(8)
|
EBITDA of $1,900m in the quarter (Q4 2020: $2,284m) has been
negatively impacted by the $1,154m (QTD 2020: $nil) unwind of
inventory fair value uplift recognised on acquisition of Alexion,
as well as increased restructuring charges arising from the Post
Alexion Acquisition Group Review. The unwind of inventory fair
value is expected to depress EBITDA over approximately 18 months
post-acquisition in line with revenues.
Table 17: Reconciliation of Reported to Core financial measures -
FY 2021
FY 2021
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisition of Alexion[60]
|
Other[61]
|
Core[62]
|
Core
% change
|
Reported% change
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
$m
|
Gross Profit
|
24,980
|
722
|
66
|
2,206
|
(1)
|
27,973
|
30
|
30
|
Gross Profit Margin
|
66.0%
|
|
|
|
|
74.2%
|
-6
|
-5
|
Distribution Expense
|
(446)
|
-
|
-
|
-
|
-
|
(446)
|
12
|
7
|
R&D Expense
|
(9,736)
|
223
|
1,496
|
28
|
2
|
(7,987)
|
36
|
33
|
SG&A Expense
|
(15,234)
|
338
|
3,584
|
207
|
1
|
(11,104)
|
19
|
15
|
Total Operating Expense
|
(25,416)
|
561
|
5,080
|
235
|
3
|
(19,537)
|
25
|
22
|
Other Operating Income & Expense
|
1,492
|
-
|
-
|
-
|
-
|
1,492
|
(3)
|
(4)
|
Operating Profit
|
1,056
|
1,283
|
5,146
|
2,441
|
2
|
9,928
|
35
|
41
|
Operating Margin
|
2.8%
|
|
|
|
|
26.5%
|
-1
|
+1
|
Net Finance Expense
|
(1,257)
|
-
|
-
|
-
|
395
|
(862)
|
10
|
11
|
Taxation
|
380
|
(249)
|
(1,024)
|
(531)
|
(70)
|
(1,494)
|
14
|
19
|
EPS
|
$0.08
|
$0.73
|
$2.91
|
$1.34
|
$0.23
|
$5.29
|
32
|
37
|
Table 18: Reconciliation of Reported to Core financial measures -
Q4 2021
FY 2021
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Acquisition of Alexion57
|
Other58
|
Core59
|
Core
% change
|
Reported% change
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
$m
|
Gross Profit
|
7,386
|
501
|
19
|
1,157
|
(3)
|
9,060
|
53
|
59
|
Gross Profit Margin
|
59.8%
|
|
|
|
|
74.3%
|
-4
|
-2
|
Distribution Expense
|
(124)
|
-
|
-
|
-
|
-
|
(124)
|
14
|
13
|
R&D Expense
|
(2,584)
|
68
|
101
|
18
|
1
|
(2,396)
|
40
|
40
|
SG&A Expense
|
(5,117)
|
166
|
1,607
|
41
|
(65)
|
(3,368)
|
19
|
18
|
Total Operating Expense
|
(7,825)
|
234
|
1,708
|
59
|
(64)
|
(5,888)
|
27
|
26
|
Other Operating Income & Expense
|
147
|
-
|
(1)
|
-
|
-
|
146
|
(77)
|
(78)
|
Operating Profit
|
(292)
|
735
|
1,726
|
1,216
|
(67)
|
3,318
|
75
|
94
|
Operating Margin
|
-2.4%
|
|
|
|
|
27.6%
|
+2
|
+5
|
Net Finance Expense
|
(335)
|
-
|
-
|
-
|
102
|
(233)
|
14
|
16
|
Taxation
|
290
|
(156)
|
(327)
|
(289)
|
(15)
|
(497)
|
67
|
88
|
EPS
|
$(0.22)
|
$0.37
|
$0.91
|
$0.60
|
$0.01
|
$1.67
|
56
|
74
|
Profit and Loss summary
a) Gross Profit
Reported Gross Profit Margin in the year declined 14 (13 at CER)
percentage points to 66%; Core Gross Profit Margin declined six
(five at CER) percentage points in the year to 74.2% predominantly
reflecting the equitable supply, at no profit to AstraZeneca, of
the pandemic COVID-19 vaccine, together with an increasing impact
from profit-sharing arrangements
(primarily Lynparza and
roxadustat). These effects were partially offset by the
contribution from Alexion from 21 July 2021 and a larger proportion
of Oncology sales. Reported Gross Profit Margin has also been
impacted by restructuring charges and the unwind of the fair value
adjustment to Alexion inventories at the date of acquisition. The
fair value uplift is expected to unwind through Reported Cost of
Sales over the 18 months post-acquisition, and in Q4 2021, the
impact of the fair value uplift unwind on Cost of Sales was
$1,154m. Variations in gross margin performance between periods can
be expected to continue.
b) Total Operating Expense
Reported Total Operating Expense increased in the year by 44% (40%
at CER) to $25,416m. Core Total Operating Expense increased by 25%
(22% at CER) to $19,537m and represented 52% of Total Revenue (FY
2020: 59%).
Reported R&D Expense increased in the year by 62% (59% at CER)
to $9,736m including intangible asset impairment charges recognised
in the year of $1,464m of which $1,172m relates to the impairment
recorded in the third quarter on an intangible asset related to the
acquisition of Ardea Biosciences, Inc. in 2012, following the
decision to discontinue the development of verinurad.
Core R&D Expense increased in the year by 36% (33% at CER) to
$7,987m with increases in both Reported and Core R&D Expense
reflecting the Company's continued investment
in Vaxzevria and Evusheld, and other costs related to COVID-19, such as
personal protective equipment and colleague COVID-19 testing across
the Company. The increases also reflected the investment in several
late-stage Oncology trials and the advancement of a number of Phase
II clinical development programmes in BioPharmaceuticals, mainly in
CVRM. In the year, grant income of $533m has been recognised, of
which $309m has been offset against the US clinical trial costs
for Vaxzevria and $224m offset against costs
for Evusheld.
Reported SG&A Expense increased in the year by 35% (32% at CER)
to $15,234m including the increased amortisation of intangible
assets related to the Alexion acquisition, increased restructuring
charges of $338m primarily comprise supply chain restructuring,
exit costs for de-prioritised R&D projects, and severance
payments. Intangible asset impairment charges of $603m have been
recorded in SG&A, of which $469m relates to the impairment
of Bydureon.
Core SG&A Expense increased by 19% (15% at CER) to $11,104m,
reflecting the investment in Oncology-medicine launches, the launch
of several new BioPharmaceuticals medicines, particularly in the
US, and AstraZeneca's further expansion in Emerging
Markets.
c) Other Operating Income and Expense
Reported and Core Other Operating Income and Expense decreased in
the year to $1,492m, by 2% (4% at CER) and by 3% (4% at CER)
respectively, and included:
- Income from the divestment of AstraZeneca's
26.7% share of Viela as part of the acquisition by Horizon
Therapeutics plc. AstraZeneca received cash proceeds and profit of
$776m upon closing with the profit being recorded as Other
Operating Income
- $317m of income from an
agreement with Grünenthal to divest commercial rights
to Crestor in over 30 countries in Europe, except in
the UK and Spain
In FY 2020, Other Operating Income included divestment gains for
the commercial rights to Atacand and a number of legacy hypertension
medicines.
d) Net Finance Expense
Reported Net Finance Expense increased in the year by 3% (2% at
CER) to $1,257m, principally reflecting lower interest income on
securities and short-term deposits driven by lower interest rates,
financing costs related to the facilities and debt for the Alexion
transaction, partly offset by lower discount unwind costs on
acquisition-related liabilities, including the Diabetes Alliance.
Core Net Finance Expense increased in the year by 10% (11% at CER)
to $862m and was principally driven by the aforementioned lower
interest income and Alexion-related financing costs.
e) Taxation
The Reported Tax Rate for the year was 143% (2020: 20%), being a
tax benefit on the Reported Loss Before Tax, and the Core Tax Rate
was 17% (2020: 20%). The Reported and Core tax rates benefitted
from the following one-off favourable impacts:
-
A non-taxable gain on the divestment of the investment in Viela;
and
-
A reduction of tax liabilities arising from updates to estimates of
prior period tax liabilities following settlements with tax
authorities and on expiry of statute of limitations, partially
offset by a tax charge on recalculation of deferred tax balances
following substantive enactment of Dutch and UK Corporation Tax
rate increases.
Excluding these net benefits, the Core Tax Rate would have been
c.21%.
The net cash tax paid for the year was $1,743m (FY 2020:
$1,562m).
f) EPS
Reported EPS in the year declined 97% (84% at CER) to $0.08 (FY
2020: $2.44). Core EPS increased by 32% (37% at CER) to
$5.29.
g) Dividend per share
The Board reaffirms its commitment to the progressive dividend
policy. A second interim dividend of $1.97 per share (145.3 pence,
18.00 SEK) has been declared, meaning a full-year dividend per
share of $2.87 (210.1 pence, 25.77 SEK). Dividend payments are
normally paid as follows:
- First interim
dividend - announced with half-year and second-quarter results and
paid in September
- Second
interim dividend - announced with full-year and fourth-quarter
results and paid in March
The record date for the second interim dividend for 2021, payable
on 28 March 2022, will be 25 February 2022. The ex-dividend date
will be 24 February 2022. The record date for the first interim
dividend for 2022, payable on 12 September 2022, will be 12 August
2022. The ex-dividend date will be 11 August 2022.
Table 19: Cash Flow Summary
|
|
FY 2021
|
FY 2020
|
Change
|
|
|
$m
|
$m
|
$m
|
Reported Operating Profit
|
|
1,056
|
5,162
|
(4,106)
|
Depreciation, Amortisation and Impairment
|
|
6,530
|
3,149
|
3,381
|
Decrease in Working Capital and Short-term Provisions
|
|
2,021
|
361
|
1,721
|
Gains on Disposal of Intangible Assets
|
|
(513)
|
(1,030)
|
517
|
Gains on Disposal of Investments in Associates and Joint
Ventures
|
|
(776)
|
-
|
(776)
|
Non-Cash and Other Movements
|
|
109
|
(548)
|
596
|
Interest Paid
|
|
(721)
|
(733)
|
12
|
Taxation Paid
|
|
(1,743)
|
(1,562)
|
(181)
|
Net Cash Inflow from Operating Activities
|
|
5,963
|
4,799
|
1,164
|
Net Cash (Outflow)/Inflow before Financing Activities
|
|
(5,095)
|
4,514
|
(9,609)
|
Net Cash Inflow/(Outflow) from Financing Activities
|
|
3,649
|
(2,203)
|
5,852
|
Net Cash Inflow from Operating Activities increased in the year by
$1,164m to $5,963m.
The decrease in Net Cash (Outflow)/Inflow before Financing
Activities of $9,609m is principally due to the Alexion
acquisition, specifically the upfront payment of $13,349m, less
cash and cash equivalents acquired of $4,086m, and $211m of
payments upon vesting of employee share awards. This decrease is
partially offset by the aforementioned improvement in Net Cash
Inflow from Operating Activities.
The Reported Operating Profit of $1,056m in FY2021 includes a
negative impact of $2,198m relating to the unwind of the inventory
fair value uplift recognised on acquisition of Alexion. This is
offset by a corresponding item (positive impact of $2,198m) in
Decrease in Working Capital and Short-term Provisions. Overall, the
unwind of the fair value uplift has no impact on the Net Cash
Inflow from Operating Activities.
Capital Expenditure
Capital Expenditure amounted to $1,091m in the year (FY 2020:
$961m). This included investment in the new AstraZeneca R&D
centre on the Biomedical Campus in Cambridge, UK, to which a number
of colleagues have begun relocation.
The Company anticipates an increase in Capital Expenditure, partly
driven by an expansion in its capacity for growth across several
limited-sized projects.
Table 20: Net Debt summary
|
|
At 31 Dec 2021
|
At 31 Dec 2020
|
|
$m
|
$m
|
Cash and cash equivalents
|
|
6,329
|
7,832
|
Other investments
|
|
69
|
160
|
Cash and investments
|
|
6,398
|
7,992
|
Overdrafts and short-term borrowings
|
|
(387)
|
(658)
|
Lease liabilities
|
|
(987)
|
(681)
|
Current instalments of loans
|
|
(1,273)
|
(1,536)
|
Non-current instalments of loans
|
|
(28,134)
|
(17,505)
|
Interest-bearing loans and borrowings
(Gross Debt)
|
|
(30,781)
|
(20,380)
|
Net derivatives
|
|
61
|
278
|
Net Debt
|
|
(24,322)
|
(12,110)
|
Net Debt increased by $12,212m in the year to $24,322m primarily
due to financing the Alexion acquisition. Details of the committed
undrawn bank facilities are disclosed within the going concern
section of Note 1. Details in regards to the funding of the Alexion
acquisition are provided within Note 5.
In July 2021, following the acquisition of Alexion, S&P Global
Ratings upgraded AstraZeneca's long-term credit rating to A-. Other
than this, there were no changes to the Company's solicited credit
ratings during the year to 31 December 2021. At 31 December 2021,
the Company's solicited credit ratings from S&P were A- (long
term) and A-2 (short term), and from Moody's Investor Service were
A3 (long term) and P-2 (short term).
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.
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, 1.750% Notes due 2028
and 2.250% Notes due 2031 (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 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 Form 6-K furnished to the SEC on
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 21: Obligor group summarised Statement of Comprehensive
income
|
|
FY 2021
|
FY 2020
|
|
$m
|
$m
|
Total revenue
|
|
-
|
-
|
Gross profit
|
|
-
|
-
|
Operating loss
|
|
(157)
|
(45)
|
Loss for the period
|
|
(773)
|
(663)
|
Transactions with subsidiaries that are not issuers or
guarantors
|
|
5,914
|
2,637
|
Table 22: Obligor group summarised Statement of Financial position
information
|
|
At 31 Dec 2021
|
At 31 Dec 2020
|
|
$m
|
$m
|
Current assets
|
|
8
|
26
|
Non-current assets
|
|
-
|
4
|
Current liabilities
|
|
(1,442)
|
(1,720)
|
Non-current liabilities
|
|
(25,646)
|
(17,161)
|
Amounts due from subsidiaries that are not issuers or
guarantors
|
|
11,510
|
7,011
|
Amounts due to subsidiaries that are not issuers or
guarantors
|
|
(293)
|
(290)
|
Foreign exchange
The Company's transactional currency exposures on working capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies' reporting currency. Foreign-exchange
gains and losses on forward contracts for transactional hedging are
taken to profit or loss. In addition, the Company's external
dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment
date.
Table 23: Currency sensitivities
The Company provides the following currency-sensitivity
information:
|
|
|
Average exchange
rates versus USD
|
|
Annual impact of 5%
strengthening in exchange rate versus USD ($m)[63]
|
Currency
|
Primary Relevance
|
|
FY
2021[64]
|
YTD
2022[65]
|
% change
|
Total Revenue
|
Core Operating Profit
|
CNY
|
Total Revenue
|
|
6.43
|
6.36
|
1
|
277
|
158
|
EUR
|
Total Revenue
|
|
0.85
|
0.88
|
(4)
|
317
|
160
|
JPY
|
Total Revenue
|
|
109.83
|
114.90
|
(5)
|
229
|
158
|
Other[66]
|
|
|
|
|
|
420
|
196
|
GBP
|
Operating Expense
|
|
0.73
|
0.74
|
(1)
|
61
|
(93)
|
SEK
|
Operating Expense
|
|
8.58
|
9.14
|
(7)
|
6
|
(82)
|
Sustainability
AstraZeneca's sustainability approach has three priority
areas[67],
aligned with the Company's purpose and business
strategy:
- Access to healthcare
- Environmental protection
- Ethics and transparency
Recent developments and progress against the Company's priorities
are reported below.
a) Access to healthcare
In the fourth quarter of 2021, the Company delivered approximately
102 million doses of its COVID-19 vaccine through COVAX. As of the
end December 2021, the Company and its sublicensee SII had
delivered more than 247 million doses with COVAX to 130 countries.
AstraZeneca and its sublicensee SII remain the largest contributor
to COVAX. As of February 2022, AstraZeneca and its sub-licensing
partners have released more than 2.6 billion vaccine doses, for
supply in over 180 countries. Approximately two thirds of the doses
have gone to low and middle-income countries.
The Company's Healthy Heart
Africa (HHA) programme marked its seventh anniversary in Kenya at
the joint Pan-African Society of Cardiology/Kenya Cardiac Society
(PASCAR/KCS) Congress in Mombasa in November. The HHA programme
featured during a panel session on Health system resilience to
improve and maintain access to cardiovascular diseases care,
chaired by Professor Elijah Ogola, Secretary General of PASCAR and
Principal investigator for the HHA programme. Since the programme
launched in 2015, HHA has conducted over 23 million blood pressure
screenings, identified over 4.5 million elevated readings,
activated over 950 sites and trained more than 9,000 healthcare
workers and volunteers.
During
the quarter, the Company's Young
Health Programme (YHP), in collaboration with Plan International UK
and various public sector bodies, reached more than 815,000 young
people with health information and advocacy initiatives, including
successful expansion into Japan, Jordan and Malaysia. This, along
with new reporting from UNICEF, brings the reach of the YHP in 2021
to almost four million young people.
On International Day of the Girl on October 11, 2021, the YHP
platform was used to promote awareness of inclusion and diversity
through the global #GirlsBelongHere campaign which placed more than
50 girls into mentorship opportunities with Senior Executive Team
and Board members, providing a valuable opportunity to share
viewpoints and sharpen internal
awareness on the barriers to women in the
workplace.
In collaboration with One Young World, the YHP also hosted a
session at COP26 in November, on the intersection of health and
climate, with an emphasis on adolescent health. This focus
continued in remarks given by Company Chairman Leif Johansson at
the invitation of UNICEF at the inaugural Global Forum for
Children and Youth in
December 7. At this Forum, the Company pledged its commitment to
the "Commitment to Children and Youth Platform", also reinforcing
the links to the Sustainable Development
Goals.
Research is now underway in eight of the 13 countries selected as
part of Phase 2 of The Partnership for Health System
Sustainability and Resilience (PHSSR)
policy programme. New partners have joined the initiative
including Philips, KPMG and the European Observatory on Health
Systems and Policies. AstraZeneca convened
a hybrid summit on health system sustainability and
resilience at EXPO2020 in Dubai in January, together
with health ministers, key partners and former Heads of
State.
b) Environmental protection
The Company made good progress in reducing its Scope 1 and 2
greenhouse gas emissions. As at the end of December 2021, the
Company had achieved 59% reduction compared with its 2015 baseline.
All imported electricity is now from renewable sources. This
includes the full integration of Alexion's carbon footprint and
rebasing 2015.
Following the launch of the Sustainable Markets
Initiative (SMI) Health Systems Taskforce at
COP26, the Taskforce has convened several times
under Chief Executive Officer Pascal Soriot's leadership, to
progress towards its ambition of accelerating the
delivery of net zero healthcare.
In December 2021, AstraZeneca was CDP
AA rated for Climate and Water for the sixth
year in succession, recognised for its environmental
leadership in both climate change and water security. The Company
was also rated for the first time for the restoration of
forests and ecosystems, gaining a C rating.
In November 2021, the Company announced a new partnership with
Forestry England and Borders Forest Trust to plant one
million trees across the UK that will support reforestation
efforts across England and Southern Scotland. Through Forestry
England, planting efforts will initially be focused on
Thetford Forest, 30 miles from the Company's new Cambridge
Discovery Centre, and in the Goyt Valley, ten miles from
AstraZeneca's Macclesfield site, as both areas have suffered in
recent years from the impact of pests and disease. In Scotland,
planting will focus on two 'wild heart' sites, aimed at reviving
the Wild Heart of Southern Scotland and bringing back lost habitats
in the area.
In December 2021, the Company announced a partnership
with Future
Biogas to build a new
renewable energy plant to generate biomethane, as a substitute for
natural gas, to provide a
renewable source of heat and power for AstraZeneca's UK sites in
Macclesfield, Cambridge, Speke, and Luton. This initiative will
help, in part, with the Company's transition to 100% renewable
energy for heat and power, as well as provide additional renewable
gas to the UK gas grid.
c) Ethics and transparency
In November 2021, the Company was recognised as one of the most
sustainable pharmaceutical companies with 6th position
in their sector in the Dow Jones Sustainability Index
(DJSI). In January
2022, for the fifth year in a
row, the Company was ranked amongst the Corporate
Knights Global 100 most sustainable corporations, following an
assessment of nearly 7,000 public companies.
In January 2022, AstraZeneca's inclusion in the Bloomberg Gender
Equality Index for 2022 was confirmed for the fourth consecutive
year. Gender equality is vitally important to AstraZeneca, as women
excelling in scientific careers is key to ensuring the Company is
truly inclusive and representative of the communities in which it
operates.
In collaboration with an independent consultancy, and with input
from our Sustainability Advisory Board (SAB) AstraZeneca used the
results of its 2021 Materiality Assessment survey and stakeholder
input to prioritise those issues
where it can have the most positive impacts on patients, healthcare
systems, the environment and society. The materiality assessment
confirmed the existing strategic priority pillars and identified
nine broader material focus areas, which will be reflected
in the overall
sustainability strategy and priorities going forward. Following
this exercise, it was agreed that the SAB had fulfilled its
remit.
Research and development
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
Significant new trials in Oncology where the first patient was
dosed as of 10 February 2022 included, DESTINY-Breast11, a Phase
III trial of Enhertu in neoadjuvant HER2+ breast cancer, and
TROPION-Breast01 a Phase III trial of datopotamab deruxtecan in
metastatic HR+, HER2-negative breast cancer.
AstraZeneca presented new data across its diverse portfolio of
cancer medicines at the San Antonio Breast Cancer Symposium
(SABCS), the 63rd American Society of Hematology (ASH) Annual
Meeting in December 2021, and at the American Society of Clinical
Oncology Gastrointestinal Cancers Symposium (ASCO GI) in January
2022.
Data presented at SABCS included 33 abstracts spanning 14 medicines
and potential new medicines including new analyses from the
DESTINY-Breast03 Phase III trial of Enhertu, early data in advanced triple negative breast
cancer from the TROPION-PanTumor01 Phase I trial of datopotamab
deruxtecan and the BEGONIA Phase Ib/II trial
of Imfinzi in combination with oleclumab and
capivasertib.
ASH featured more than 25 abstracts across the Company's
haematology portfolio and pipeline, including an oral presentation
of three-year follow-up data from the ASCEND Phase III trial for
the use of Calquence in relapsed or refractory chronic
lymphocytic leukaemia.
ASCO GI featured over 20 abstracts, including data
from Imfinzi plus tremelimumab in 1st-line unresectable
liver cancer in the HIMALAYA Phase III trial, as well as initial
results for Imfinzi from the TOPAZ-1 Phase III trial in advanced
biliary tract cancer.
Imfinzi
In January 2022, AstraZeneca presented results from the HIMALAYA
Phase III trial at the aforementioned 2022 ASCO GI meeting. The
results showed a single priming dose of tremelimumab added
to Imfinzi demonstrated a statistically significant and
clinically meaningful improvement in OS[68] versus
sorafenib as a 1st-line treatment for patients with unresectable
HCC who had not received prior systemic therapy and were not
eligible for localised treatment.
Patients on the STRIDE[69] regimen
saw a 22% reduction in risk of death versus sorafenib (HR 0.78,
96.02% CI 0.65-0.93; p=0.0035). Median OS was 16.4 months
versus 13.8 for sorafenib. An estimated 31% of patients were still
alive at three years versus 20% for sorafenib. Results also showed
an increase in ORR[70] with
the STRIDE regimen versus sorafenib (20.1% vs. 5.1%). Median
DoR[71] was
22.3 months with the STRIDE regimen versus 18.4 with sorafenib. The
addition of tremelimumab to Imfinzi did not increase severe liver toxicity, and
no bleeding risk was observed.
HIMALAYA also tested Imfinzi monotherapy, which demonstrated non-inferior
OS to sorafenib (HR 0.86; 95.67% CI 0.73-1.03; non-inferiority
margin 1.08) with a median OS of 16.6 months versus 13.8, and an
improved tolerability profile versus sorafenib.
In January 2022, AstraZeneca also presented results from an interim
analysis of TOPAZ-1, where patients treated
with Imfinzi in combination with standard-of-care
chemotherapy experienced a 20% reduction in the risk of death
versus chemotherapy alone (HR of 0.80; 95% CI, 0.66-0.97; 2-sided
p=0.021). Median OS was 12.8 months versus 11.5 for chemotherapy.
An estimated 25% of patients were still alive at two years
versus 10% for chemotherapy.
Results also showed a 25% reduction in the risk of disease
progression or death with Imfinzi plus chemotherapy (HR, 0.75; 95% CI,
0.64-0.89; 2-sided p=0.001). Median PFS was 7.2 months for the
combination versus 5.7 for chemotherapy. Patients treated
with Imfinzi plus chemotherapy achieved an ORR of 26.7%
versus 18.7% for patients treated with chemotherapy
alone. Imfinzi plus chemotherapy did not increase the
discontinuation rate due to AEs compared to chemotherapy
alone.
During the period, AstraZeneca received regulatory submission
acceptance in the US and EU and completed regulatory submission in
Japan for Imfinzi +/- tremelimumab use in the treatment of in
1st-line Stage IV non-small cell lung cancer based on the results
of the POSEIDON Phase III trial.
Lynparza
In November 2021, AstraZeneca announced that the supplemental New
Drug Application (sNDA) for Lynparza had been accepted and granted Priority
Review in the US for the adjuvant treatment of patients with
BRCA-mutated HER2-negative high-risk early breast cancer who have
already been treated with chemotherapy either before or after
surgery.
During the period, AstraZeneca received regulatory submission
acceptance in the EU for Lynparza use in the treatment of 1st-line mCRPC based
on the results of the PROpel Phase III trial.
Enhertu
In January 2022, AstraZeneca and Daiichi Sankyo received
notification that the supplemental Biologics License Application
(sBLA) for Enhertu had been accepted and granted Priority
Review in the US for the treatment of adult patients in the US with
unresectable or metastatic HER2-positive breast cancer who have
received a prior anti-HER2-based regimen based on the results of
the DESTINY-Breast03 Phase III trial. Regulatory submission
acceptance has also been received in the EU, and submission made in
Japan, based on the results of this trial.
During the period, Enhertu was assigned category 1 status in the NCCN
guidelines for both for the second-line treatment of HER2-positive
metastatic breast cancer, and in the first-line setting for
patients whose disease is rapidly progressing following neoadjuvant
or adjuvant therapy.
BioPharmaceuticals - CVRM
Significant new trials in CVRM where the first patient was dosed
during the period included STABILIZE-CKD, a Phase III trial
of Lokelma to evaluate the effect of the medicine as an
adjunct to ACEi[72] or
ARB[73] therapy
on slowing CKD progression in patients with hyperkalaemia or at
high risk of hyperkalaemia.
Brilinta
During the period, the Company decided to withdraw its EMA
regulatory application seeking approval
for Brilique to
reduce the risk of stroke in patients with an acute ischaemic
stroke or high-risk transient ischaemic
attack. Brilinta is approved in the aforementioned indication
in the US.
Lokelma
In November 2021, AstraZeneca was granted Fast Track Designation in
the US for the investigation of Lokelma to reduce arrhythmia-related cardiovascular
outcomes in patients on chronic haemodialysis with recurrent
hyperkalaemia. The designation is based on the potential
of Lokelma to
reduce serious adverse CV outcomes in this patient
population.
Lokelma is currently being
evaluated in this indication in the ongoing Phase III
DIALIZE-Outcomes trial.
Eplontersen
In January 2022, eplontersen was granted ODD by the US
FDA[74] for
the treatment of transthyretin-mediated amyloidosis. Eplontersen is
currently in Phase III clinical trials for amyloid transthyretin
cardiomyopathy (ATTR-CM) and amyloid transthyretin polyneuropathy
(ATTR-PN).
BioPharmaceuticals - Respiratory & Immunology
Tezspire (tezepelumab)
During the period, Tezspire received US regulatory approval following a
Priority Review for the add-on maintenance treatment of adult and
paediatric patients aged 12 years and older with severe
asthma. Tezspire is the only biologic approved for severe
asthma with no phenotype (e.g. eosinophilic or allergic) or
biomarker limitation within its approved label. The approval was
based on efficacy and safety data from the PATHFINDER clinical
trial programme. The application included results from the pivotal
NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every
primary and key secondary endpoint in patients with severe asthma,
compared to placebo, when added to standard
therapy.
In October 2021, tezepelumab was granted Orphan Drug Designation by
the FDA for the treatment of eosinophilic esophagitis.
Saphnelo
During the period, Saphnelo was recommended for approval in the EU by
the CHMP of the European Medicines Agency as an add-on therapy for
the treatment of adult patients with moderate to severe, active
autoantibody-positive SLE, despite receiving standard therapy. The
positive opinion is based on results from
the Saphnelo clinical development programme, which
included two TULIP Phase III trials and the MUSE Phase II trial. In
these trials, more patients treated with Saphnelo experienced a reduction in overall disease
activity across all affected organ systems from baseline and
achieved sustained reduction in oral corticosteroid use compared to
placebo, with both groups receiving standard therapy. The Company
anticipates a regulatory decision for the EU in H1
2022.
Rare Disease
Ultomiris
During the period, Alexion announced that its sBLA
for Ultomiris had been accepted and granted Priority
Review in the US for the treatment of adults with generalised
myasthenia gravis. The FDA set a Prescription Drug User Fee Act
date during the second quarter of 2022, following use of a priority
review voucher.
COVID-19
COVID-19 vaccines
In January 2022, a preliminary analysis of a safety and
immunogenicity trial (D7220C00001) showed
that Vaxzevria, when given as a third dose booster, increased
the immune response to Beta, Delta, Alpha and Gamma SARS-CoV-2
variants, while a separate analysis showed increased antibody
response to the Omicron variant.
Positive interim results of the trial and additional analysis
demonstrated that AZD2816 generated a similar immune response
to Vaxzevria against variants of concern, including
Omicron, and AZD2816 and Vaxzevria were found to be generally well tolerated.
Given these data, the low circulation of the Beta variant and the
substantial body of evidence supporting Vaxzevria against current variants of concern,
AstraZeneca has discontinued the AZD2816 development programme and
will continue to focus on the supply of Vaxzevria around the world.
Evusheld (AZD7442,
tixagevimab/cilgavimab)
In November, an analysis of the ongoing PROVENT Phase III trial
evaluating a median six months of participant follow-up, showed one
300mg i.m.[75] dose
of Evusheld reduced the risk of developing symptomatic
COVID-19 compared to placebo by 83%.
During the period, Evusheld received Emergency Use Authorisation (EUA)
in the US for the pre-exposure prophylaxis (prevention) of COVID-19
and received similar authorisations in other markets, including
France and Bahrain.
In December, pre-clinical data from 'live' virus neutralisation
data from both University College Oxford, UK and Washington
University School of Medicine, St. Louis, US, published
in pre-print,
demonstrated that Evusheld retained neutralising activity against the
Omicron SARS-CoV-2 variant (B.1.1.529). Evusheld's Inhibitory Concentration 50 (IC50), a measure
of neutralising potency of an antibody, was within the range of
neutralising antibody titres found in individuals who have been
previously infected with and recovered naturally from
COVID-19.
These findings are in line with pseudovirus
neutralising data from
independent investigators at the FDA announced on 16 December 2021,
and add to the growing body of preclinical evidence demonstrating
that Evusheld retains activity against all tested
SARS-CoV-2 variants of concern to date.
Condensed Financial Statements
Table 24: FY 2021 - Condensed consolidated statement of
comprehensive income
For the year ended 31 December
|
2021
|
2020
|
$m
|
$m
|
Total Revenue
|
37,417
|
26,617
|
Product Sales
|
36,541
|
25,890
|
Collaboration Revenue
|
876
|
727
|
Cost of Sales
|
(12,437)
|
(5,299)
|
Gross profit
|
24,980
|
21,318
|
Distribution costs
|
(446)
|
(399)
|
Research and development expense
|
(9,736)
|
(5,991)
|
Selling, general and administrative expense
|
(15,234)
|
(11,294)
|
Other operating income and expense
|
1,492
|
1,528
|
Operating profit
|
1,056
|
5,162
|
Finance income
|
43
|
87
|
Finance expense
|
(1,300)
|
(1,306)
|
Share of after tax losses in associates and joint
ventures
|
(64)
|
(27)
|
(Loss)/Profit before tax
|
(265)
|
3,916
|
Taxation
|
380
|
(772)
|
Profit for the period
|
115
|
3,144
|
|
|
|
Other comprehensive (loss)/income
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
Remeasurement of the defined benefit pension liability
|
626
|
(168)
|
Net (losses)/gains on equity investments measured at fair value
through other comprehensive income
|
(187)
|
938
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
-
|
(1)
|
Tax on items that will not be reclassified to profit or
loss
|
105
|
(81)
|
|
544
|
688
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
Foreign exchange arising on consolidation
|
(483)
|
443
|
Foreign exchange arising on designated borrowings in net investment
hedges
|
(321)
|
573
|
Fair value movements on cash flow hedges
|
(167)
|
180
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
208
|
(254)
|
Fair value movements on derivatives designated in net investment
hedges
|
34
|
8
|
(Costs)/gains of hedging
|
(6)
|
9
|
Tax on items that may be reclassified subsequently to profit or
loss
|
46
|
(39)
|
|
(689)
|
920
|
Other comprehensive (loss)/income for the period, net of
tax
|
(145)
|
1,608
|
Total comprehensive (loss)/income for the period
|
(30)
|
4,752
|
|
|
|
Profit attributable to:
|
|
|
Owners of the Parent
|
112
|
3,196
|
Non-controlling interests
|
3
|
(52)
|
|
115
|
3,144
|
Total comprehensive income attributable to:
|
|
|
Owners of the Parent
|
(33)
|
4,804
|
Non-controlling interests
|
3
|
(52)
|
|
(30)
|
4,752
|
Basic earnings per $0.25 Ordinary Share
|
$0.08
|
$2.44
|
Diluted earnings per $0.25 Ordinary Share
|
$0.08
|
$2.44
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,418
|
1,312
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,427
|
1,313
|
Table 25: Q4 2021 - Condensed consolidated statement of
comprehensive income
For the quarter ended 31 December
|
2021
|
2020
|
$m
|
$m
|
Total Revenue
|
12,011
|
7,410
|
Product Sales
|
11,498
|
7,011
|
Collaboration Revenue
|
513
|
399
|
Cost of Sales
|
(4,625)
|
(1,525)
|
Gross profit
|
7,386
|
5,885
|
Distribution costs
|
(124)
|
(109)
|
Research and development expense
|
(2,584)
|
(1,719)
|
Selling, general and administrative expense
|
(5,117)
|
(3,210)
|
Other operating income and expense
|
147
|
640
|
Operating (loss)/profit
|
(292)
|
1,487
|
Finance income
|
1
|
7
|
Finance expense
|
(336)
|
(321)
|
Share of after tax losses in associates and joint
ventures
|
(9)
|
(6)
|
(Loss)/Profit before tax
|
(636)
|
1,167
|
Taxation
|
290
|
(162)
|
(Loss)/Profit for the period
|
(346)
|
1,005
|
|
|
|
Other comprehensive (loss)/income
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
Remeasurement of the defined benefit pension liability
|
34
|
23
|
Net losses on equity investments measured at fair value through
other comprehensive income
|
(331)
|
(36)
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
(4)
|
-
|
Tax on items that will not be reclassified to profit or
loss
|
34
|
(11)
|
|
(267)
|
(24)
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
Foreign exchange arising on consolidation
|
(115)
|
564
|
Foreign exchange arising on designated borrowings in net investment
hedges
|
(46)
|
428
|
Fair value movements on cash flow hedges
|
(64)
|
178
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
71
|
(139)
|
Fair value movements on derivatives designated in net investment
hedges
|
12
|
(31)
|
Costs of hedging
|
-
|
(1)
|
Tax on items that may be reclassified subsequently to profit or
loss
|
9
|
(46)
|
|
(133)
|
953
|
Other comprehensive (loss)/income for the period, net of
tax
|
(400)
|
929
|
Total comprehensive (loss)/income for the period
|
(746)
|
1,934
|
|
|
|
(Loss)/Profit attributable to:
|
|
|
Owners of the Parent
|
(347)
|
1,012
|
Non-controlling interests
|
1
|
(7)
|
|
(346)
|
1,005
|
Total comprehensive (loss)/income attributable to:
|
|
|
Owners of the Parent
|
(747)
|
1,940
|
Non-controlling interests
|
1
|
(6)
|
|
(746)
|
1,934
|
Basic earnings per $0.25 Ordinary Share
|
$(0.22)
|
$0.78
|
Diluted earnings per $0.25 Ordinary Share
|
$(0.22)
|
$0.78
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,547
|
1,312
|
Diluted weighted average number of Ordinary Shares in issue
(millions)[76]
|
1,547
|
1,313
|
Table 26: Condensed consolidated statement of financial
position
|
At 31 Dec 2021
|
At 31 Dec2020
|
$m
|
$m
|
Assets
|
|
|
Non-current assets
|
|
|
Property, plant and equipment
|
9,183
|
8,251
|
Right-of-use assets
|
988
|
666
|
Goodwill
|
19,997
|
11,845
|
Intangible assets
|
42,387
|
20,947
|
Investments in associates and joint ventures
|
69
|
39
|
Other investments
|
1,168
|
1,108
|
Derivative financial instruments
|
102
|
171
|
Other receivables
|
895
|
720
|
Deferred tax assets
|
4,330
|
3,438
|
|
79,119
|
47,185
|
Current assets
|
|
|
Inventories
|
8,983
|
4,024
|
Trade and other receivables
|
9,644
|
7,022
|
Other investments
|
69
|
160
|
Derivative financial instruments
|
83
|
142
|
Intangible assets
|
105
|
-
|
Income tax receivable
|
663
|
364
|
Cash and cash equivalents
|
6,329
|
7,832
|
Assets held for sale
|
368
|
-
|
|
26,244
|
19,544
|
Total assets
|
105,363
|
66,729
|
|
|
|
Liabilities
|
|
|
Current liabilities
|
|
|
Interest-bearing loans and borrowings
|
(1,660)
|
(2,194)
|
Lease liabilities
|
(233)
|
(192)
|
Trade and other payables
|
(18,938)
|
(15,785)
|
Derivative financial instruments
|
(79)
|
(33)
|
Provisions
|
(768)
|
(976)
|
Income tax payable
|
(916)
|
(1,127)
|
|
(22,594)
|
(20,307)
|
Non-current liabilities
|
|
|
Interest-bearing loans and borrowings
|
(28,134)
|
(17,505)
|
Lease liabilities
|
(754)
|
(489)
|
Derivative financial instruments
|
(45)
|
(2)
|
Deferred tax liabilities
|
(6,206)
|
(2,918)
|
Retirement benefit obligations
|
(2,454)
|
(3,202)
|
Provisions
|
(956)
|
(584)
|
Other payables
|
(4,933)
|
(6,084)
|
|
(43,482)
|
(30,784)
|
Total liabilities
|
(66,076)
|
(51,091)
|
Net assets
|
39,287
|
15,638
|
Equity
|
|
|
Capital and reserves attributable to equity holders of the
Parent
|
|
|
Share capital
|
387
|
328
|
Share premium account
|
35,126
|
7,971
|
Other reserves
|
2,045
|
2,024
|
Retained earnings
|
1,710
|
5,299
|
|
39,268
|
15,622
|
Non-controlling interests
|
19
|
16
|
Total equity
|
39,287
|
15,638
|
Table 27: 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 2020
|
328
|
7,941
|
2,046
|
2,812
|
13,127
|
1,469
|
14,596
|
Profit for the period
|
-
|
-
|
-
|
3,196
|
3,196
|
(52)
|
3,144
|
Other comprehensive income
|
-
|
-
|
-
|
1,608
|
1,608
|
-
|
1,608
|
Transfer to other reserves
|
-
|
-
|
(22)
|
1,423
|
1,401
|
(1,401)
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(3,668)
|
(3,668)
|
-
|
(3,668)
|
Issue of Ordinary Shares
|
-
|
30
|
-
|
-
|
30
|
-
|
30
|
Share-based payments charge for the period
|
-
|
-
|
-
|
277
|
277
|
-
|
277
|
Settlement of share plan awards
|
-
|
-
|
-
|
(349)
|
(349)
|
-
|
(349)
|
Net movement
|
-
|
30
|
(22)
|
2,487
|
2,495
|
(1,453)
|
1,042
|
At 31 Dec 2020
|
328
|
7,971
|
2,024
|
5,299
|
15,622
|
16
|
15,638
|
At 1 Jan 2021
|
328
|
7,971
|
2,024
|
5,299
|
15,622
|
16
|
15,638
|
Profit for the period
|
-
|
-
|
-
|
112
|
112
|
3
|
115
|
Other comprehensive loss
|
-
|
-
|
-
|
(145)
|
(145)
|
-
|
(145)
|
Transfer to other reserves
|
-
|
-
|
21
|
(21)
|
-
|
-
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(3,882)
|
(3,882)
|
-
|
(3,882)
|
Issue of Ordinary Shares
|
59
|
27,155
|
-
|
-
|
27,214
|
-
|
27,214
|
Share-based payments charge for the period
|
-
|
-
|
-
|
615
|
615
|
-
|
615
|
Settlement of share plan awards
|
-
|
-
|
-
|
(781)
|
(781)
|
-
|
(781)
|
Issue of replacement share awards upon acquisition
|
-
|
-
|
-
|
513
|
513
|
-
|
513
|
Net movement
|
59
|
27,155
|
21
|
(3,589)
|
23,646
|
3[77]
|
23,649
|
At 31 Dec 2021
|
387
|
35,126
|
2,045
|
1,710
|
39,268
|
19
|
39,287
|
Table 28: Condensed consolidated statement of cash
flows
For the year ended 31 December
|
2021
|
2020
|
$m
|
$m
|
Cash flows from operating activities
|
|
|
(Loss)/Profit before tax
|
(265)
|
3,916
|
Finance income and expense
|
1,257
|
1,219
|
Share of after tax losses of associates and joint
ventures
|
64
|
27
|
Depreciation, amortisation and impairment
|
6,530
|
3,149
|
Decrease in working capital and short-term provisions
|
2,021
|
361
|
Gains on disposal of intangible assets
|
(513)
|
(1,030)
|
Gains on disposal of investments in associates and joint
ventures
|
(776)
|
-
|
Fair value movements on contingent consideration arising from
business combinations
|
14
|
(272)
|
Non-cash and other movements
|
95
|
(276)
|
Cash generated from operations
|
8,427
|
7,094
|
Interest paid
|
(721)
|
(733)
|
Tax paid
|
(1,743)
|
(1,562)
|
Net cash inflow from operating activities
|
5,963
|
4,799
|
Cash flows from investing activities
|
|
|
Acquisition of subsidiaries, net of cash acquired
|
(9,263)
|
-
|
Payments upon vesting of employee share awards attributable to
business combinations
|
(211)
|
-
|
Payment of contingent consideration from business
combinations
|
(643)
|
(822)
|
Purchase of property, plant and equipment
|
(1,091)
|
(961)
|
Disposal of property, plant and equipment
|
13
|
106
|
Purchase of intangible assets
|
(1,109)
|
(1,645)
|
Disposal of intangible assets
|
587
|
951
|
Movement in profit-participation liability
|
20
|
40
|
Purchase of non-current asset investments
|
(184)
|
(119)
|
Disposal of non-current asset investments
|
9
|
1,381
|
Movement in short-term investments, fixed deposits and other
investing instruments
|
96
|
745
|
Payments to associates and joint ventures
|
(92)
|
(8)
|
Disposal of investments in associates and joint
ventures
|
776
|
-
|
Interest received
|
34
|
47
|
Net cash outflow from investing activities
|
(11,058)
|
(285)
|
Net cash (outflow)/inflow before financing activities
|
(5,095)
|
4,514
|
Cash flows from financing activities
|
|
|
Proceeds from issue of share capital
|
29
|
30
|
Issue of loans and borrowings
|
12,929
|
2,968
|
Repayment of loans and borrowings
|
(4,759)
|
(1,609)
|
Dividends paid
|
(3,856)
|
(3,572)
|
Hedge contracts relating to dividend payments
|
(29)
|
(101)
|
Repayment of obligations under leases
|
(240)
|
(207)
|
Movement in short-term borrowings
|
(276)
|
288
|
Payments to acquire non-controlling interests
|
(149)
|
-
|
Net cash inflow/(outflow) from financing activities
|
3,649
|
(2,203)
|
Net (decrease)/increase in cash and cash equivalents in the
period
|
(1,446)
|
2,311
|
Cash and cash equivalents at the beginning of the
period
|
7,546
|
5,223
|
Exchange rate effects
|
(62)
|
12
|
Cash and cash equivalents at the end of the period
|
6,038
|
7,546
|
Cash and cash equivalents consist of:
|
|
|
Cash and cash equivalents
|
6,329
|
7,832
|
Overdrafts
|
(291)
|
(286)
|
|
6,038
|
7,546
|
Notes to the Condensed Financial Statements
1) Basis of preparation and accounting policies
The Condensed Consolidated Financial Statements for the year ended
31 December 2021 have been prepared in accordance with UK-adopted
International Accounting Standards and with the requirements of the
Companies Act 2006 as applicable to companies reporting under those
standards. The Condensed Consolidated Financial Statements also
comply fully with International Financial Reporting Standards
(IFRSs) as issued by the International Accounting Standards Board
(IASB) and International Accounting Standards as adopted by the
European Union. On 31 December 2020, EU-adopted IFRS was brought
into UK law and became UK-adopted international accounting
standards, with future changes to IFRS being subject to endorsement
by the UK Endorsement Board. The Condensed Consolidated Financial
Statements transitioned to UK-adopted International Accounting
Standards for financial periods beginning 1 January 2021. This
change constitutes a change in accounting framework. However, there
is no impact on recognition, measurement or disclosure in the
period reported as a result of the change in
framework.
The Condensed Consolidated Financial Statements for the year ended
31 December 2021 include Alexion's post-acquisition results which
have been consolidated into the Group's results from 21 July 2021,
therefore are not entirely comparable with respective comparative
periods shown. Following the acquisition of Alexion, the Group has
reviewed its assessment of reportable segments under IFRS 8
'Operating Segments' and concluded that the Group continues to have
one reportable segment.
These Condensed Consolidated Financial Statements comprise the
financial results of AstraZeneca PLC for the years to 31 December
2021 and 2020 together with the Statement of financial position as
at 31 December 2021 and 2020. The results for the year to 31
December 2021 have been extracted from the 31 December 2021 audited
Consolidated Financial Statements which have been approved by the
Board of Directors. These have not yet been delivered to the
Registrar of Companies but are expected to be published on 22
February 2022 within the Annual Report and Form 20-F Information
2021.
The financial information set out above does not constitute the
Group's statutory accounts for the years to 31
December 2021 or 2020 but is derived from those accounts. The
auditors have reported on those accounts;
their reports (i) were 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 in respect of the accounts for the year to 31 December
2021 or 31 December 2020. Statutory accounts for the year to 31
December 2021 were approved by the Board of Directors for release
on 10 February 2022.
Except as noted below, the Condensed Consolidated 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
2020.
IFRS 9 and IFRS 7
The replacement of benchmark interest rates such as LIBOR and other
interbank offered rates (IBORs) is a priority for global
regulators. Phase 2 amendments to IFRS 9 'Financial Instruments'
and IFRS 7 'Financial Instruments: Disclosures' were issued in
August 2021 and have been adopted by the Group for 2021 reporting.
As at 31 December 2021, the Group held instruments totalling
$1,439m that reference USD LIBOR but will either have matured or
will have their last LIBOR fixings set before the relevant USD
LIBORs cease publication on 30 June 2023. These instruments
include floating rates bonds, interest rate swaps and other
arrangements. The group also has $4bn of term bank loans that
currently reference US LIBOR but these agreements have a mandatory
switch from US LIBOR to an alternative risk free rate on 30 June
2023, should the group not elect to do so before that
date.
COVID-19
AstraZeneca has assessed the impact of the uncertainty presented by
the COVID-19 pandemic on the Consolidated Financial Statements
comprising the financial results to 31 December 2021 and the
financial position as at 31 December 2021, specifically considering
the impact on key judgements and significant estimates as detailed
on page 180 of the Annual Report and 20-F
Information 2020 along
with several other areas of elevated risk during the pandemic
period.
A detailed assessment has been performed, focussing on the
following areas:
-
recoverable value of goodwill, intangible assets and property,
plant and equipment
-
impact on key assumptions used to estimate contingent consideration
liabilities
-
key assumptions used in estimating the Group's defined benefit
pension obligations
-
basis for estimating clinical trial accruals
-
key assumptions used in estimating rebates, chargebacks and returns
for US Product Sales
-
valuations of unlisted equity investments
-
expected credit losses associated with changes in credit risk
relating to trade and other receivables
-
net realisable value of inventories
-
fair value of certain financial instruments
-
recoverability of deferred tax assets
-
effectiveness of hedge relationships
There were no material accounting impacts identified relating to
the above areas during the year ended 31 December
2021.
The Group will continue to monitor these areas of increased
judgement, estimation and risk for material changes.
Going concern
The Group has considerable financial resources available. As at 31
December 2021, the Group had $11.2bn in financial resources (cash
and cash-equivalent balances of $6.3bn and undrawn committed bank
facilities of $4.9bn available until April 2025, with only $1.9bn
of borrowings due within one year). All facilities contain no
financial covenants and were undrawn at 31 December
2021.
The directors have considered the impact of COVID-19 on
AstraZeneca's operations and mitigations to these risks. Overall,
the impact of these items would heighten certain risks, such as
those relating to the delivery of the pipeline or launch of new
medicines, the execution of AstraZeneca's commercial strategy, the
manufacturing and supply of medicines and reliance on third-party
goods and services. The Group is continuously monitoring and
mitigating where possible impacts of these risks.
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 affect adversely 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, the going concern basis has been adopted in these
Condensed 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 2020.
Financial information
The comparative figures for the financial year ended 31 December
2020 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.
2) Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for
triggers at an individual asset or cash-generating-unit level were
conducted, and impairment tests carried out where triggers were
identified. As a result and following the Group undertaking a
portfolio prioritisation of development projects, total net
impairment charges of $2,085m have been recorded against intangible
assets during the year ended 31 December 2021 (FY 2020: $240m). Net
impairment charges in respect of launched medicines and medicines
in development were $603m (FY 2020: $185m) and $1,464m (FY 2020:
$55m) respectively. Impairments on launched products included $469m
recognised in the quarter on Bydureon (revised carrying amount of
$50m). Impairments recorded on products in
development included an impairment charge of $1,172m recognised in
the third quarter on the Ardea intangible asset as a consequence of
the decision to discontinue the development of
verinurad.
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 27 of the Annual Report and Form
20-F Information 2020. Net Debt
is a non-GAAP financial measure.
Table 29: Net Debt
|
At 1 Jan 2021
|
Cash flow
|
Acquisitions
|
Non-cash & other
|
Exchange movements
|
At 31 Dec 2021
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Non-current instalments of loans
|
(17,505)
|
(12,929)
|
(187)
|
2,244
|
243
|
(28,134)
|
Non-current instalments of leases
|
(489)
|
-
|
(228)
|
(52)
|
15
|
(754)
|
Total long-term debt
|
(17,994)
|
(12,929)
|
(415)
|
2,192
|
258
|
(28,888)
|
Current instalments of loans
|
(1,536)
|
4,781
|
(2,336)
|
(2,268)
|
86
|
(1,273)
|
Current instalments of leases
|
(192)
|
254
|
(34)
|
(269)
|
8
|
(233)
|
Bank collateral
|
(288)
|
195
|
-
|
-
|
-
|
(93)
|
Other short-term borrowings excluding overdrafts
|
(84)
|
81
|
-
|
-
|
-
|
(3)
|
Overdraft
|
(286)
|
(31)
|
-
|
-
|
26
|
(291)
|
Total current debt
|
(2,386)
|
5,280
|
(2,370)
|
(2,537)
|
120
|
(1,893)
|
Gross borrowings
|
(20,380)
|
(7,649)
|
(2,785)
|
(345)
|
378
|
(30,781)
|
Net derivative financial instruments
|
278
|
-
|
6
|
(223)
|
-
|
61
|
Net borrowings
|
(20,102)
|
(7,649)
|
(2,779)
|
(568)
|
378
|
(30,720)
|
Cash and cash equivalents
|
7,832
|
(5,501)
|
4,086
|
-
|
(88)
|
6,329
|
Other investments - current
|
160
|
(89)
|
-
|
-
|
(2)
|
69
|
Cash and investments
|
7,992
|
(5,590)
|
4,086
|
-
|
(90)
|
6,398
|
Net Debt
|
(12,110)
|
(13,239)
|
1,307
|
(568)
|
288
|
(24,322)
|
Non-cash movements in the period include fair-value adjustments
under IFRS 9.
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 was $93m (FY 2020:
$288m) and the carrying value of such cash collateral posted by the
Group was $47m (FY 2020: $11m). Cash collateral posted by the Group
is presented within Cash and cash equivalents.
Other investments - non-current are included within the balance of
$1,168m (31 December 2020: $1,108m) in the Condensed Consolidated
statement of financial position. 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 liability of $2,458m (31 December 2020: $2,297m), $920m of
which is shown in current other payables and $1,538m is shown in
non-current other payables. In April 2021, AstraZeneca exercised
its option to acquire the remaining 45% of shares in
Acerta.
Net Debt increased by $12,212m in the year to $24,322m primarily
due to financing the Alexion acquisition. Details of the committed
undrawn bank facilities are disclosed within the going concern
section of Note 1. Details in regards to the funding of the Alexion
acquisition are provided within Note 5.
In July 2021, following the acquisition of Alexion, S&P Global
Ratings upgraded AstraZeneca's long-term credit rating to
A-. Other than this, there were no changes to the Company's
solicited credit ratings during the year to 31 December
2021. At 31 December 2021, the Company's solicited credit
ratings from S&P were A- (long term) and A-2 (short term) and
from Moody's were A3 (long term) and P-2 (short
term).
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. During the year ended 31
December 2021, equity investments previously categorised as Level 3
in the fair-value hierarchy (carrying value of $113m at 31 December
2020) are now categorised as Level 1 (carrying value of $69m at 31
December 2021) on availability of quoted prices in the market.
There have been no other changes of significance to the
categorisation or fair-value hierarchy classification of financial
instruments from those detailed in the Notes to the Group Financial
Statements in the Annual Report and Form
20-F Information 2020.
The Group holds certain equity investments that are categorised as
Level 3 in the fair value hierarchy and for which fair value gains
of $nil (FY 2020: $63m gain) have been recognised in the year ended
31 December 2021. All other fair value gains and/or losses that are
presented in Net gains on equity investments measured at fair value
through other comprehensive income in the Condensed consolidated
statement of comprehensive income for the year ended 31 December
2021 are Level 1 fair value measurements.
Financial instruments measured at fair value include $1,237m of
other investments, $4,772m held in money-market funds, $320m of
loans designated at fair value through profit or loss and $61m of
derivatives as at 31 December 2021. The total fair value of
interest-bearing loans and borrowings at 31 December 2021, which
have a carrying value of $30,781m in the Condensed consolidated
statement of financial position, was $33,252m. Contingent
consideration liabilities arising on business combinations have
been classified under Level 3 in the fair value hierarchy and
movements in fair value are shown below:
Table 30: Financial instruments - contingent
consideration
|
|
2021
|
2020
|
|
Diabetes alliance
|
Other
|
Total
|
Total
|
|
$m
|
$m
|
$m
|
$m
|
At 1 January
|
|
2,932
|
391
|
3,323
|
4,139
|
Settlements
|
|
(625)
|
(18)
|
(643)
|
(822)
|
Revaluations
|
|
42
|
(28)
|
14
|
(272)
|
Reclass to other payables
|
|
-
|
(55)
|
(55)
|
-
|
Discount unwind
|
|
195
|
31
|
226
|
278
|
At 31 December
|
|
2,544
|
321
|
2,865
|
3,323
|
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 $2,544m (31 December 2020:
$2,932m) would increase/decrease by $254m with an increase/decline
in sales of 10%, as compared with the current
estimates.
5) Acquisition of Alexion
On 21 July 2021, AstraZeneca completed the acquisition of 100% of
the issued shares of Alexion Pharmaceuticals, Inc (Alexion), based
in Boston, Massachusetts, US. Alexion is a global biopharmaceutical
company focused on serving patients and families affected by rare
diseases and devastating conditions through the discovery,
development and commercialisation of life-changing
medicines.
At closing, Alexion shareholders received 2.1243 AstraZeneca
American Depository Shares (ADSs) and $60 in cash for each of their
Alexion shares. Unvested Alexion employee share awards were
converted to equivalent AstraZeneca share awards. The fair value of
the purchase consideration was $41,058m, comprising AstraZeneca
ADSs of $27,196m, cash of $13,349m and replacement employee share
awards of $513m.
The Group has funded the cash element of the acquisition with $8bn
of new long-term debt, issued in May and June 2021, $4bn of term
loans drawn in July 2021 under the $17.5bn committed bank
facilities entered into in December 2020 to secure the acquisition
financing, and existing cash balances. The Group cancelled the
remaining $13.5bn of the facilities in June, July and October 2021.
Loans and borrowings of $2.3bn acquired with Alexion were repaid in
full shortly following completion of the acquisition. Changes to
financing balances during the reporting period are included in
Table 29 on Net Debt.
The acquisition has been accounted for as a business combination
using the acquisition method of accounting in accordance with IFRS
3 'Business Combinations' and consequently the Alexion assets
acquired, and liabilities assumed have been recorded by AstraZeneca
at fair value, with any excess of the purchase price over the fair
value of the identifiable assets and liabilities being recognised
as goodwill.
The fair values assigned to the Alexion business combination in
2021 were:
Table 31: Alexion acquisition fair values as of 21 July
2021
|
Fair value
$m
|
Non-current assets
|
|
Property, plant and equipment
|
1,135
|
Right-of-use assets
|
263
|
Intangible assets
|
26,855
|
Other non-current assets
|
301
|
|
28,554
|
Current assets
|
|
Inventories
|
6,769
|
Trade and other receivables
|
2,096
|
Intangible assets
|
100
|
Cash and cash equivalents
|
4,086
|
|
13,051
|
Current liabilities
|
|
Interest-bearing loans and borrowings
|
(2,336)
|
Trade and other payables
|
(1,192)
|
Other current liabilities
|
(40)
|
|
(3,568)
|
Non-current liabilities
|
|
Lease liabilities
|
(228)
|
Deferred tax liabilities
|
(4,191)
|
Other non-current liabilities
|
(697)
|
|
(5,116)
|
|
|
Total net assets acquired
|
32,921
|
|
|
Less: non-controlling interests
|
(150)
|
Goodwill
|
8,287
|
Total fair value of consideration
|
41,058
|
|
|
Less: fair value of equity consideration
|
(27,196)
|
Less: fair value of replacement employee share
awards
|
(513)
|
Less: cash and cash equivalents acquired
|
(4,086)
|
Net cash outflow
|
9,263
|
Intangible assets principally represent intellectual property
rights over launched medicines and medicines under development,
which were fair valued using the multi-period excess earnings
method. The estimated fair value and useful lives of intangible
assets were as follows:
Table 32: Alexion Intangible asset fair values and useful
lives
|
Fair value
|
Useful lives
|
|
$m
|
Years
|
Launched medicines - C5 franchise (Soliris/Ultomiris)
|
18,480
|
6-15
|
Launched medicines - Strensiq, Kanuma, Andexxa
|
5,215
|
11-17
|
Medicines in development
|
2,760
|
Not amortised
|
Other intangibles
|
500
|
5-10
|
|
26,955
|
|
The fair value of inventory, which includes raw materials, work in
progress and finished goods related to the launched medicines, was
estimated at $6,769m, an uplift of $5,635m on the carrying value
prior to the acquisition. The fair value adjustment relates only to
work in progress and finished goods and was calculated as the
estimated selling price less estimated costs to complete and sell
the inventory, the associated margins on these activities and
holding costs. The fair value adjustment is expected to amortise
over approximately the first 18 months post-acquisition, in line
with revenues.
Property, plant and equipment principally comprises the
manufacturing facilities in Dublin and Athlone, Ireland and was
fair valued using a cost approach. The estimated fair value of
$1,135m represents an uplift of $111m over carrying
value.
The estimated fair value of contingent liabilities was $76m,
relating to various claims and disputes in each case where there is
a possible, but not probable, future financial exposure. This
amount has been included within other non-current liabilities of
$697m.
The estimated fair value of trade and other receivables was
$2,096m, which approximated the contractual cash
flows.
The net tax position reflected an adjustment of $5,215m related to
the deferred tax impact of the fair value uplifts on intangible
assets, inventories, property, plant and equipment and contingent
liabilities as described above.
Goodwill amounting to $8,287m was recognised on acquisition and is
underpinned by a number of elements, which individually could not
be quantified. Most significant amongst these is the premium
attributable to a pre-existing, well positioned business in the
innovation intensive, high growth rare diseases market with a
highly skilled workforce and established reputation. Other
important elements include the potential unidentified products that
future research and development may yield and the core
technological capabilities and knowledge base of the company.
Goodwill is not expected to be deductible for
tax purposes.
Non-controlling interests reflect Alexion's pre-existing minority
equity interest in Caelum Biosciences and have been valued at
$150m, the agreed exercise price for the exclusive option to
acquire the remaining equity. The option was exercised on 28
September 2021 and the acquisition of Caelum Biosciences closed
shortly thereafter on 5 October 2021.
Alexion's results have been consolidated into the Group's results
from 21 July 2021. For the period from acquisition to
31 December 2021, before reflecting the fair value adjustments
arising on acquisition, Alexion's Total Revenues were $3,071m and
Profit after tax was $889m. If the acquisition had taken effect at
the beginning of the reporting period in which the acquisition
occurred (1 January 2021), on a pro forma basis, after
reflecting the fair value adjustments arising on consolidation, the
Total Revenue of the combined Group for the year ended 31 December
2021 would have been $41,132m and the Loss after tax would have
been $1,152m. This pro forma information does not purport to
represent the results of the combined Group that actually would
have occurred had the acquisition taken place on 1 January
2021 and should not be taken to be representative of future
results.
Total acquisition-related costs of $171m have been incurred by the
Group, which include advisory, legal and other professional fees.
These costs are presented in the Statement of Comprehensive Income
within Selling, general and administrative expense.
The terms of the acquisition include a retention bonus plan for
legacy Alexion employees whereby up to $50m may be used for
retention bonus awards to employees at the level of Vice President
or below. These bonuses will vest and be payable six months after
the acquisition, or earlier. In the period since acquisition, a
cost of $24m has been recorded in the Statement of Comprehensive
Income ($2m in Cost of Sales, $9m in Research and development
expense and $13m in Selling, general and administrative
expense).
Upon completion of the acquisition, all unvested Alexion employee
share awards were converted into AstraZeneca restricted stock
awards that continue to have, and shall be subject to, the same
terms and conditions as applied in the corresponding Alexion awards
immediately prior to completion. Alexion Performance Stock Plan
(PSU) awards that included performance-based vesting conditions
were converted using the greater of the original target level and
Alexion's assessment of the level of achievement immediately prior
to completion (subject to a limit of 175 per cent. for the awards
granted in 2019 and a limit of 150 per cent. for the awards granted
in 2020). In the period since acquisition, a cost of $257m has been
recorded in the Statement of Comprehensive Income ($9m in Cost of
sales, $73m in Research and development expense and $175m in
Selling, general and administrative expense). Payments made to the
Employee Benefit Trust upon vesting of share awards recognised as
part of the consideration for the acquisition of Alexion are
recognised within Investing activities in the Group's Statement of
cash flows.
6) Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered
typical to its business, including litigation and 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 2020, H1 2021 and
Q3 2021 results (the Disclosures). Unless noted otherwise below or
in the Disclosures, no provisions have been established in respect
of the claims discussed below.
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 that a provision has been
taken, AstraZeneca considers each of the claims to represent a
contingent liability and discloses information with respect to the
nature and facts of the cases in accordance with IAS
37.
There is one matter, which is considered probable that an outflow
will be required, but for which we are unable to make an estimate
of the possible loss or range of possible losses at this
stage.
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 fourth quarter of 2021 and to
10 February 2022
Patent litigation
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple
abbreviated New Drug Application (ANDA) filers, AstraZeneca filed
patent infringement lawsuits in the US District Court for the
District of Delaware. In its complaint, AstraZeneca alleged 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.
No trial date has been set.
Faslodex
Patent proceedings outside the US
As previously disclosed, in Japan, in October 2021, AstraZeneca
received notice that Sun Pharma Japan Ltd. requested to intervene
in the Request for Invalidation brought by Sandoz K.K seeking
invalidation of the Faslodex formulation patent. The Japan Patent Office
has permitted the intervention. AstraZeneca is defending the
challenged patent.
Farxiga/Forxiga
US patent proceedings
As previously disclosed, in 2018, in response to
Paragraph IV notices, AstraZeneca initiated abbreviated New Drug
Application (ANDA) litigation against Zydus Pharmaceuticals (USA)
Inc. (Zydus) in the US District Court for
the District of Delaware (the District Court). In
May 2021, trial against Zydus proceeded in the District Court. In
October 2021, the District Court issued a decision finding the
asserted claims of AstraZeneca's US Patent No. 6,515,117 as valid
and infringed by Zydus's proposed ANDA product.
Patent proceedings outside
the US
As previously disclosed, in Canada, in January 2021, Sandoz Canada
Inc. served three Notices of Allegation on AstraZeneca alleging
invalidity and/or non-infringement of all three patents listed on
the Canadian Patent Register in relation
to Forxiga.
AstraZeneca commenced litigation in response. A trial date has been
set for October 2022 with closing argument in December
2022.
In Canada, in February 2021, Teva Canada Limited served a Notice of
Allegation on AstraZeneca alleging invalidity and/or
non-infringement of all three patents listed on the Canadian Patent
Register in relation to Forxiga. AstraZeneca commenced litigation in response. A
trial date has been set for October 2022 with closing argument in
December 2022.
Onglyza
Patent proceedings outside the US
As previously disclosed in Canada, in November 2019, Sandoz Canada
Inc. sent a Notice of Allegation to AstraZeneca challenging the
validity of Canadian substance Patent No. 2402894 (expiry March
2021) (the '894 patent) and formulation Patent No. 2568391 (expiry
May 2025) related to Onglyza. AstraZeneca commenced an action in response
related to the '894 patent in January 2020. In October 2021, the
parties reached an agreement to resolve the dispute. This matter is
now concluded.
Symbicort
US patent proceedings
As previously disclosed, AstraZeneca is involved in ongoing
abbreviated New Drug Application (ANDA) litigation
regarding Symbicort with Mylan Pharmaceuticals Inc. (Mylan) and
Kindeva Drug Delivery L.P. (Kindeva). In December 2021, the United
States District Court of Appeals for the Federal Circuit (the
Federal Circuit) affirmed the decision by the US District Court for
the Northern District of West Virginia (the District Court)
determining that the asserted patent claims were nonobvious.
However, the Federal Circuit reversed the District Court's claim
construction decision, vacated the stipulated judgment of
infringement by Mylan and Kindeva and remanded the matter back to
the District Court for determination of whether their ANDA product
infringes the asserted patent claims under the Federal Circuit's
claim construction. In January 2022, AstraZeneca filed a Combined
Petition for Panel Rehearing and Rehearing En Banc with the Federal
Circuit.
Tagrisso
US patent proceedings
As previously disclosed, in February 2020, in response to Paragraph
IV notices from multiple abbreviated New Drug Application (ANDA)
filers, AstraZeneca filed patent infringement lawsuits in the US
District Court for the District of Delaware. In its complaint,
AstraZeneca alleged that a generic version
of Tagrisso, if approved and marketed, would infringe a US
Orange Book-listed Tagrisso patent. In the fourth quarter of 2021,
AstraZeneca entered into settlement agreements with Zydus
Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited
(collectively, Zydus) and MSN Laboratories Pvt. Ltd. and MSN
Pharmaceuticals Inc. (collectively, MSN), resolving all US patent
litigation with Zydus and MSN relating to Tagrisso. The trial with the remaining defendant, Alembic
Pharmaceuticals Limited, is scheduled for May
2022.
Patent proceedings outside the US
As previously disclosed, in Russia in October 2021, AstraZeneca
filed a lawsuit in the Arbitration Court of the Moscow Region
against Axelpharm, LLC to prevent it from obtaining authorization
to market a generic version of Tagrisso prior to the expiration of AstraZeneca's
patents covering Tagrisso. The lawsuit also names the Ministry of Health of
the Russian Federation as a third party. Neither a case schedule,
nor a trial date have been set.
Ultomiris
US patent proceedings
As previously disclosed, in November 2018, Chugai Pharmaceutical
Co., Ltd. (Chugai) filed a lawsuit against Alexion in the Delaware
District Court alleging that Ultomiris infringes a US patent held by Chugai. Upon
issuance of another US patent in November 2019, Chugai filed a
second lawsuit in the same court alleging
that Ultomiris also infringes the second patent. The two
lawsuits were consolidated. Trial scheduled to occur in January
2022 has been postponed until February 2022 due to
COVID-19.
Patent proceedings outside the US
As previously disclosed in Japan, in December 2018, Chugai
Pharmaceutical Co., Ltd (Chugai) filed a lawsuit in the Tokyo
District Court against Alexion Pharma GK in Japan and alleges
that Ultomiris infringes two Japanese patents held by
Chugai. Chugai's complaints seek unspecified damages and certain
injunctive relief. In March 2020, the Supreme Court of Japan
dismissed Chugai's appeal against an earlier IP High Court of Japan
decision which held that one of the Chugai patents-in-suit is
invalid. Subsequently, Chugai filed a correction to the claims of
this patents-in-suit and Alexion has countered that the corrected
claims are still invalid and not infringed. In all cases, Alexion
has denied the charges and countered that the patents are neither
valid nor infringed. In October 2021, the Japanese Patent Office
invalidated four Chugai patents, including those asserted in the
Tokyo District Court Case. Chugai has appealed the patent office
decision.
Product liability litigation
Farxiga and Xigduo XR
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. One case, filed in
state court in Minnesota, is scheduled for trial in January
2023.
Nexium and Losec/Prilosec
US proceedings
As previously disclosed, 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 relate to
allegations of kidney injuries. In particular, in May 2017, counsel
for a group of such plaintiffs claiming that they have been
diagnosed with kidney injuries filed a motion with the Judicial
Panel on Multidistrict Litigation (JPML) seeking the transfer of
any currently pending federal court cases as well as any similar,
subsequently filed cases to a coordinated and consolidated
pre-trial multidistrict litigation (MDL) proceeding. In August
2017, the JPML granted the motion and consolidated the pending
federal court cases in an MDL proceeding in federal court in New
Jersey for pre-trial purposes. A trial in the MDL previously
scheduled for January 2022 has been rescheduled to October 2022. In
addition to the MDL cases, there are cases filed in several state
courts around the US; a trial in Delaware state court previously
scheduled for February 2022 is being
rescheduled.
In addition, AstraZeneca has been defending lawsuits involving
allegations of gastric cancer following treatment with PPIs. One
such claim is filed in the US District Court for the Middle
District of Louisiana, where the court has scheduled a trial for
November 2022.
Canada proceedings
As previously disclosed, in Canada, in July and August 2017,
AstraZeneca was served with three putative class action lawsuits.
Two of the lawsuits have been dismissed, one in 2019 and one in
2021. The third lawsuit, filed in Saskatchewan, seeks authorisation
to represent individual residents in Canada who allegedly suffered
kidney injuries from the use of proton pump inhibitors,
including Nexium and Losec.
Onglyza and Kombiglyze
As previously disclosed, in the US, AstraZeneca is defending
various lawsuits alleging heart failure, cardiac injuries, and/or
death from treatment with Onglyza or Kombiglyze. In February 2018, the Judicial Panel on
Multidistrict Litigation ordered the transfer of various pending
federal actions to the US District Court for the Eastern District
of Kentucky (the District Court) for consolidated pre-trial
proceedings with the federal actions pending in the District Court.
In the previously disclosed California State Court coordinated
proceeding, AstraZeneca submitted its motion for summary judgment
in December 2021.
Commercial litigation
Anti-Terrorism Act Civil Lawsuit
As previously disclosed, in July 2020, the US District Court for
the District of Columbia (the District Court) granted AstraZeneca's
and certain other pharmaceutical and/or medical device companies'
motion and dismissed a lawsuit filed by US nationals (or their
estates, survivors, or heirs) who were killed or wounded in Iraq
between 2005 and 2011, which had alleged that the defendants
violated the US Anti-Terrorism Act and various state laws by
selling pharmaceuticals and medical supplies to the Iraqi Ministry
of Health. The plaintiffs appealed the District Court's order
dismissing the litigation to the DC Circuit Court of Appeals (the
Appellate Court), and in January 2022, a panel on the Appellate
Court reversed the dismissal and remanded the case back to the
District Court. AstraZeneca and the other defendants have filed
petitions requesting en banc review by the entire Appellate
Court.
Syntimmune
In connection with Alexion's prior acquisition of Syntimmune, Inc.,
(Syntimmune) a clinical-stage biotechnology company developing an
antibody therapy targeting the FcRn, in the US, in December 2020,
Alexion was served with a lawsuit filed by the stockholders'
representative for Syntimmune in Delaware State Court that alleged,
among other things, breaches of contractual obligations relating to
the 2018 merger agreement. The stockholders' representative alleges
that Alexion failed to meet its obligations under the merger
agreement to use commercially reasonable efforts to achieve the
milestones, and the plaintiff has requested payment of all
milestone obligations. Alexion also filed a claim for breach of the
representations in the 2018 merger agreement regarding unusable
drug product and drug substance that Alexion acquired from
Syntimmune. Trial in the matter is scheduled for November
2022.
Government investigations/proceedings
US 340B litigations and proceedings
As previously disclosed, AstraZeneca is involved in several matters
relating to its contract pharmacy recognition policy under the 340B
Drug Pricing Program in the US. In 2020, three lawsuits were filed
by covered entities and advocacy groups against the US Department
of Health and Human Services, the US Health Resources and Services
Administration as well as other US government agencies and their
officials. The complaints allege, among other things, that these
agencies should enforce an interpretation of the governing statute
for the 340B Drug Pricing Program that would require drug
manufacturers participating in the program to offer their drugs for
purchase at statutorily capped rates to an unlimited number of
contract pharmacies. AstraZeneca has sought to intervene in the
lawsuits. Two of the three cases are currently stayed pending
further proceedings and the third case has been dismissed.
Administrative Dispute Resolution proceedings have also been
initiated against AstraZeneca before the US Health Resources and
Services Administration.
In February 2021, AstraZeneca received a Civil Investigative
Subpoena from the Attorney General's Office for the State of
Vermont seeking documents and information relating to AstraZeneca's
contract pharmacy recognition policy under the 340B Drug Pricing
Program. AstraZeneca has cooperated with the inquiry.
In January 2021, AstraZeneca filed a separate lawsuit in federal
court in Delaware alleging that an Advisory Opinion issued by the
Department of Health and Human Services violates the Administrative
Procedure Act. In June 2021, the Court found in favour of
AstraZeneca, invalidating the Advisory Opinion. Prior to the
Court's ruling, however, in May 2021, the US government issued new
and separate letters to AstraZeneca (and other companies) asserting
that our contract pharmacy policy violates the 340B statute. In
July 2021, AstraZeneca amended the complaint to include allegations
challenging the letter sent in May. In September 2021, the US
government issued a follow-up letter to AstraZeneca (and other
companies) asserting that it has referred the matter to the Office
of Inspector General for further review and consideration. In
October 2021, oral arguments were held before the federal court in
Delaware challenging the letters sent in May and
September.
In September 2021, AstraZeneca was served with a class-action
antitrust complaint filed in federal court in New York by Mosaic
Health on behalf of a purported class. The complaint alleges that
AstraZeneca conspired with Sanofi-Aventis U.S., LLC, Eli Lilly and
Company, Lilly USA, LLC, and Novo Nordisk Inc to restrict access to
340B discounts in the diabetes market through contract
pharmacies.
US Congressional
In January 2019, AstraZeneca received a letter from the
US House of Representatives Committee on Oversight and Reform
(Committee) seeking information related to pricing practices
for Crestor. Similar letters were sent
to 11 other pharmaceutical manufacturers. AstraZeneca
cooperated with the inquiry and produced certain
responsive information. In December 2021, the Committee issued
a final report culminating the Committee's pharmaceutical pricing
investigation. AstraZeneca's products are not the subject of the
findings in the final report.
7) Subsequent Events
On 4 January 2022, AstraZeneca completed the sale of the global
rights to Tudorza and Duaklir to Covis Pharma GmbH for an upfront payment
of $270m, which will be recorded within Other operating income and
expense. The intangible assets of $368m associated with this
transaction were classified as Assets held for sale as at 31
December 2021.
8) Table 33: FY 2021 - Product Sales year-on-year
analysis[78]
The CER information in respect of FY 2021 included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
|
|
|
World
|
|
Emerging Markets
|
|
US
|
|
|
Europe
|
|
Established RoW
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Oncology
|
13,048
|
20
|
18
|
3,223
|
11
|
6
|
5,359
|
26
|
2,484
|
28
|
22
|
1,982
|
13
|
13
|
Tagrisso
|
5,015
|
16
|
13
|
1,336
|
11
|
6
|
1,780
|
14
|
986
|
32
|
25
|
913
|
13
|
14
|
Imfinzi
|
2,412
|
18
|
16
|
277
|
76
|
68
|
1,245
|
5
|
485
|
31
|
25
|
405
|
23
|
23
|
Lynparza
|
2,348
|
32
|
30
|
384
|
45
|
41
|
1,087
|
24
|
618
|
42
|
35
|
259
|
29
|
28
|
Calquence
|
1,238
|
n/m
|
n/m
|
20
|
n/m
|
n/m
|
1,089
|
n/m
|
111
|
n/m
|
n/m
|
18
|
n/m
|
n/m
|
Koselugo
|
108
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
104
|
n/m
|
3
|
n/m
|
n/m
|
-
|
-
|
-
|
Enhertu
|
17
|
n/m
|
n/m
|
12
|
n/m
|
n/m
|
-
|
-
|
4
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
Orpathys
|
16
|
n/m
|
n/m
|
16
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex
|
948
|
7
|
3
|
619
|
10
|
5
|
13
|
n/m
|
147
|
5
|
(1)
|
169
|
(7)
|
(7)
|
Faslodex
|
431
|
(26)
|
(27)
|
167
|
(8)
|
(10)
|
30
|
(46)
|
113
|
(49)
|
(52)
|
121
|
(2)
|
(1)
|
Iressa
|
183
|
(32)
|
(35)
|
151
|
(31)
|
(35)
|
11
|
(23)
|
5
|
(58)
|
(60)
|
16
|
(26)
|
(26)
|
Casodex
|
143
|
(17)
|
(21)
|
105
|
(21)
|
(26)
|
-
|
-
|
3
|
(3)
|
6
|
35
|
(3)
|
(3)
|
Arimidex
|
139
|
(25)
|
(27)
|
106
|
(28)
|
(31)
|
-
|
-
|
4
|
5
|
7
|
29
|
(15)
|
(14)
|
Others
|
50
|
1
|
(1)
|
29
|
3
|
1
|
-
|
-
|
5
|
51
|
43
|
16
|
(16)
|
(15)
|
BioPharmaceuticals: CVRM
|
8,020
|
13
|
10
|
3,780
|
18
|
14
|
2,124
|
2
|
1,494
|
22
|
16
|
622
|
7
|
5
|
Farxiga
|
3,000
|
53
|
49
|
1,195
|
74
|
70
|
732
|
29
|
810
|
60
|
52
|
263
|
34
|
31
|
Brilinta
|
1,472
|
(8)
|
(10)
|
328
|
(29)
|
(31)
|
735
|
1
|
346
|
1
|
(4)
|
63
|
8
|
(1)
|
Bydureon
|
385
|
(14)
|
(15)
|
3
|
(25)
|
(26)
|
321
|
(16)
|
55
|
5
|
-
|
6
|
(40)
|
(44)
|
Onglyza
|
360
|
(23)
|
(26)
|
179
|
(11)
|
(14)
|
88
|
(47)
|
61
|
5
|
(1)
|
32
|
(29)
|
(33)
|
Byetta
|
55
|
(19)
|
(19)
|
12
|
61
|
75
|
26
|
(31)
|
11
|
(20)
|
(25)
|
6
|
(36)
|
(38)
|
Other diabetes
|
59
|
26
|
24
|
18
|
n/m
|
n/m
|
22
|
(12)
|
17
|
35
|
31
|
2
|
11
|
12
|
Lokelma
|
175
|
n/m
|
n/m
|
3
|
(44)
|
(48)
|
115
|
n/m
|
13
|
n/m
|
n/m
|
44
|
n/m
|
n/m
|
Roxadustat
|
174
|
n/m
|
n/m
|
174
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Crestor
|
1,096
|
(7)
|
(10)
|
775
|
4
|
-
|
80
|
(13)
|
52
|
(60)
|
(62)
|
189
|
(11)
|
(10)
|
Seloken/Toprol-XL
|
951
|
16
|
10
|
928
|
19
|
13
|
1
|
(89)
|
11
|
(33)
|
(33)
|
11
|
9
|
(3)
|
Atacand
|
97
|
(60)
|
(60)
|
28
|
(84)
|
(84)
|
4
|
(65)
|
65
|
87
|
86
|
-
|
n/m
|
n/m
|
Others
|
196
|
3
|
(2)
|
137
|
9
|
3
|
-
|
-
|
53
|
(7)
|
(8)
|
6
|
(21)
|
(25)
|
BioPharmaceuticals: Respiratory & Immunology
|
6,034
|
13
|
9
|
1,749
|
9
|
4
|
2,404
|
24
|
1,247
|
6
|
1
|
634
|
(2)
|
(5)
|
Symbicort
|
2,728
|
-
|
(2)
|
609
|
7
|
4
|
1,065
|
4
|
670
|
(3)
|
(8)
|
384
|
(12)
|
(17)
|
Fasenra
|
1,258
|
33
|
31
|
20
|
67
|
67
|
790
|
31
|
286
|
41
|
34
|
162
|
24
|
22
|
Pulmicort
|
962
|
(3)
|
(8)
|
770
|
(3)
|
(9)
|
72
|
1
|
73
|
-
|
(5)
|
47
|
(13)
|
(15)
|
Daliresp
|
227
|
5
|
4
|
4
|
-
|
(2)
|
207
|
9
|
15
|
(32)
|
(37)
|
1
|
(3)
|
(10)
|
Breztri
|
203
|
n/m
|
n/m
|
55
|
n/m
|
n/m
|
115
|
n/m
|
7
|
n/m
|
n/m
|
26
|
n/m
|
n/m
|
Bevespi
|
54
|
12
|
12
|
4
|
n/m
|
n/m
|
39
|
(11)
|
11
|
n/m
|
n/m
|
-
|
-
|
-
|
Saphnelo
|
8
|
n/m
|
n/m
|
-
|
-
|
-
|
8
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
594
|
49
|
42
|
287
|
41
|
32
|
108
|
n/m
|
185
|
5
|
-
|
14
|
1
|
(6)
|
Rare Disease*
|
3,070
|
8
|
9
|
196
|
11
|
18
|
1,828
|
8
|
682
|
7
|
9
|
364
|
7
|
11
|
Soliris*
|
1,874
|
1
|
2
|
170
|
1
|
8
|
1,068
|
4
|
439
|
(8)
|
(7)
|
197
|
8
|
11
|
Ultomiris*
|
688
|
27
|
29
|
9
|
n/m
|
n/m
|
381
|
20
|
169
|
73
|
74
|
129
|
4
|
11
|
Strensiq*
|
378
|
13
|
13
|
10
|
81
|
78
|
297
|
13
|
36
|
2
|
3
|
35
|
9
|
14
|
Andexxa*
|
68
|
(3)
|
(3)
|
-
|
n/m
|
n/m
|
50
|
(21)
|
18
|
7
|
6
|
-
|
n/m
|
n/m
|
Kanuma*
|
62
|
20
|
21
|
7
|
n/m
|
n/m
|
32
|
13
|
20
|
7
|
9
|
3
|
14
|
25
|
Other medicines
|
2,367
|
(8)
|
(10)
|
954
|
(2)
|
(5)
|
221
|
(39)
|
596
|
(17)
|
(19)
|
596
|
12
|
15
|
Nexium
|
1,326
|
(11)
|
(12)
|
705
|
(7)
|
(10)
|
128
|
(24)
|
62
|
(13)
|
(18)
|
431
|
(13)
|
(12)
|
Synagis
|
410
|
10
|
13
|
35
|
-
|
-
|
23
|
(51)
|
203
|
(38)
|
(37)
|
149
|
-
|
-
|
FluMist
|
253
|
(14)
|
(17)
|
2
|
15
|
2
|
27
|
(62)
|
222
|
1
|
(2)
|
2
|
(50)
|
(53)
|
Losec/Prilosec
|
180
|
(2)
|
(7)
|
152
|
-
|
(7)
|
1
|
(89)
|
26
|
32
|
31
|
1
|
(82)
|
(72)
|
Seroquel XR/IR
|
92
|
(21)
|
(20)
|
46
|
(17)
|
(15)
|
12
|
(30)
|
29
|
2
|
2
|
5
|
(71)
|
(67)
|
Others
|
106
|
(16)
|
(19)
|
14
|
n/m
|
n/m
|
30
|
(45)
|
54
|
(5)
|
(9)
|
8
|
(13)
|
(19)
|
COVID-19
|
4,002
|
n/m
|
n/m
|
2,259
|
n/m
|
n/m
|
64
|
n/m
|
1,101
|
n/m
|
n/m
|
578
|
n/m
|
n/m
|
Vaxzevria
|
3,917
|
n/m
|
n/m
|
2,240
|
n/m
|
n/m
|
64
|
n/m
|
1,035
|
n/m
|
n/m
|
578
|
n/m
|
n/m
|
Evusheld
|
85
|
n/m
|
n/m
|
19
|
n/m
|
n/m
|
-
|
-
|
66
|
n/m
|
n/m
|
-
|
-
|
-
|
Total Product Sales
|
36,541
|
41
|
38
|
12,161
|
40
|
36
|
12,000
|
39
|
7,604
|
50
|
44
|
4,776
|
36
|
36
|
9) Table 34: Q4 2021 - Product Sales year-on-year
analysis[79]
The Q4 2021 information in respect of the three months ended 31
December 2021 included in the Consolidated Financial Information
has not been audited by PricewaterhouseCoopers LLP.
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Oncology
|
3,455
|
19
|
20
|
785
|
18
|
15
|
1,488
|
27
|
661
|
15
|
17
|
521
|
6
|
12
|
Tagrisso
|
1,314
|
14
|
15
|
325
|
26
|
23
|
486
|
15
|
258
|
5
|
7
|
245
|
6
|
12
|
Imfinzi
|
634
|
14
|
15
|
65
|
47
|
44
|
330
|
10
|
138
|
19
|
21
|
101
|
7
|
14
|
Lynparza
|
629
|
27
|
28
|
103
|
49
|
46
|
294
|
20
|
161
|
30
|
32
|
71
|
21
|
28
|
Calquence
|
395
|
n/m
|
n/m
|
8
|
n/m
|
n/m
|
336
|
91
|
43
|
n/m
|
n/m
|
8
|
n/m
|
n/m
|
Koselugo
|
34
|
92
|
94
|
-
|
-
|
-
|
32
|
82
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
Enhertu
|
7
|
n/m
|
n/m
|
5
|
-
|
-
|
-
|
-
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
Orpathys
|
6
|
n/m
|
n/m
|
6
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex
|
232
|
7
|
7
|
154
|
15
|
12
|
2
|
n/m
|
35
|
(2)
|
(2)
|
41
|
(13)
|
(7)
|
Faslodex
|
101
|
(22)
|
(21)
|
44
|
15
|
14
|
6
|
(40)
|
20
|
(61)
|
(61)
|
31
|
(1)
|
7
|
Iressa
|
35
|
(49)
|
(47)
|
29
|
(50)
|
(51)
|
2
|
(52)
|
1
|
(45)
|
5
|
3
|
(31)
|
(38)
|
Casodex
|
22
|
(43)
|
(42)
|
13
|
(55)
|
(56)
|
-
|
-
|
-
|
n/m
|
n/m
|
9
|
(9)
|
-
|
Arimidex
|
33
|
(9)
|
(11)
|
26
|
(2)
|
(5)
|
-
|
-
|
-
|
n/m
|
n/m
|
7
|
(26)
|
(24)
|
Others
|
13
|
3
|
5
|
7
|
(9)
|
(9)
|
-
|
-
|
1
|
n/m
|
n/m
|
5
|
(8)
|
(11)
|
BioPharmaceuticals: CVRM
|
2,003
|
9
|
9
|
868
|
12
|
10
|
576
|
(1)
|
386
|
17
|
18
|
173
|
10
|
14
|
Farxiga
|
848
|
45
|
46
|
318
|
61
|
60
|
228
|
24
|
225
|
57
|
60
|
77
|
28
|
32
|
Brilinta
|
348
|
(4)
|
(4)
|
71
|
3
|
1
|
178
|
(9)
|
83
|
(2)
|
(1)
|
16
|
9
|
5
|
Bydureon
|
91
|
(25)
|
(25)
|
1
|
(28)
|
(43)
|
78
|
(26)
|
12
|
(14)
|
(13)
|
-
|
(88)
|
(79)
|
Onglyza
|
75
|
(28)
|
(29)
|
28
|
(40)
|
(41)
|
25
|
(20)
|
14
|
(10)
|
(11)
|
8
|
(27)
|
(29)
|
Byetta
|
10
|
(44)
|
(42)
|
2
|
n/m
|
n/m
|
5
|
(59)
|
2
|
(32)
|
(36)
|
1
|
(56)
|
(47)
|
Other diabetes
|
17
|
34
|
34
|
6
|
n/m
|
n/m
|
7
|
17
|
4
|
7
|
14
|
-
|
-
|
-
|
Lokelma
|
54
|
90
|
95
|
-
|
n/m
|
n/m
|
34
|
70
|
5
|
n/m
|
n/m
|
15
|
n/m
|
n/m
|
Roxadustat
|
30
|
n/m
|
n/m
|
30
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Crestor
|
259
|
(13)
|
(13)
|
178
|
(6)
|
(7)
|
21
|
-
|
9
|
(73)
|
(73)
|
51
|
(5)
|
1
|
Seloken/Toprol-XL
|
202
|
1
|
(2)
|
197
|
4
|
1
|
-
|
n/m
|
2
|
(57)
|
(57)
|
3
|
14
|
3
|
Atacand
|
21
|
(67)
|
(67)
|
3
|
(93)
|
(93)
|
-
|
(87)
|
18
|
36
|
33
|
-
|
n/m
|
n/m
|
Others
|
48
|
4
|
3
|
34
|
5
|
2
|
-
|
n/m
|
12
|
(2)
|
1
|
2
|
28
|
18
|
BioPharmaceuticals: Respiratory & Immunology
|
1,590
|
4
|
4
|
445
|
(19)
|
(21)
|
647
|
23
|
335
|
11
|
11
|
163
|
6
|
8
|
Symbicort
|
681
|
-
|
-
|
152
|
5
|
3
|
262
|
(2)
|
171
|
(1)
|
-
|
96
|
1
|
-
|
Fasenra
|
357
|
26
|
27
|
5
|
n/m
|
n/m
|
234
|
30
|
75
|
19
|
21
|
43
|
12
|
18
|
Pulmicort
|
248
|
(33)
|
(34)
|
193
|
(40)
|
(42)
|
19
|
5
|
23
|
31
|
32
|
13
|
(2)
|
-
|
Daliresp
|
59
|
8
|
8
|
1
|
24
|
(24)
|
54
|
11
|
4
|
(16)
|
(21)
|
-
|
-
|
-
|
Breztri
|
73
|
n/m
|
n/m
|
15
|
n/m
|
n/m
|
47
|
n/m
|
3
|
n/m
|
n/m
|
8
|
69
|
81
|
Bevespi
|
15
|
24
|
26
|
1
|
n/m
|
n/m
|
10
|
(3)
|
4
|
n/m
|
n/m
|
-
|
-
|
-
|
Saphnelo
|
7
|
n/m
|
n/m
|
-
|
-
|
-
|
7
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Others
|
150
|
20
|
18
|
78
|
(4)
|
(8)
|
14
|
n/m
|
55
|
25
|
26
|
3
|
69
|
62
|
Rare Disease†
|
1,759
|
10
|
11
|
131
|
81
|
91
|
1,043
|
8
|
380
|
3
|
5
|
205
|
6
|
12
|
Soliris†
|
1,076
|
4
|
6
|
117
|
71
|
82
|
608
|
4
|
240
|
(12)
|
(10)
|
111
|
7
|
11
|
Ultomiris†
|
391
|
24
|
26
|
4
|
n/m
|
n/m
|
214
|
15
|
100
|
67
|
68
|
73
|
5
|
14
|
Strensiq†
|
219
|
17
|
18
|
6
|
71
|
68
|
173
|
19
|
20
|
(1)
|
1
|
20
|
8
|
15
|
Andexxa†
|
39
|
-
|
(1)
|
-
|
-
|
-
|
30
|
(14)
|
9
|
n/m
|
n/m
|
-
|
-
|
-
|
Kanuma†
|
34
|
16
|
17
|
4
|
n/m
|
n/m
|
18
|
12
|
11
|
-
|
3
|
1
|
(27)
|
1
|
Other medicines
|
825
|
13
|
15
|
199
|
(18)
|
(18)
|
41
|
(34)
|
329
|
14
|
13
|
256
|
85
|
97
|
Nexium
|
328
|
(13)
|
(10)
|
129
|
(33)
|
(33)
|
30
|
(29)
|
15
|
23
|
24
|
154
|
19
|
27
|
Synagis
|
239
|
n/m
|
n/m
|
20
|
n/m
|
n/m
|
1
|
n/m
|
121
|
56
|
58
|
97
|
n/m
|
n/m
|
FluMist
|
178
|
(1)
|
(4)
|
1
|
(18)
|
(31)
|
4
|
(21)
|
171
|
1
|
(3)
|
2
|
(44)
|
(35)
|
Losec/Prilosec
|
41
|
7
|
6
|
36
|
9
|
6
|
-
|
(78)
|
5
|
44
|
44
|
-
|
-
|
-
|
Seroquel XR/IR
|
19
|
(3)
|
(2)
|
10
|
(33)
|
(31)
|
-
|
(90)
|
8
|
6
|
6
|
1
|
(19)
|
(1)
|
Others
|
20
|
(48)
|
(49)
|
3
|
n/m
|
n/m
|
6
|
(67)
|
9
|
(49)
|
(49)
|
2
|
(48)
|
(50)
|
COVID-19
|
1,866
|
n/m
|
n/m
|
1,202
|
n/m
|
n/m
|
64
|
n/m
|
365
|
n/m
|
n/m
|
235
|
n/m
|
n/m
|
Vaxzevria
|
1,781
|
n/m
|
n/m
|
1,183
|
n/m
|
n/m
|
64
|
n/m
|
299
|
n/m
|
n/m
|
235
|
n/m
|
n/m
|
Evusheld
|
85
|
n/m
|
n/m
|
19
|
n/m
|
n/m
|
-
|
-
|
66
|
n/m
|
n/m
|
-
|
-
|
-
|
Total Product Sales
|
11,498
|
64
|
65
|
3,630
|
63
|
61
|
3,859
|
65
|
2,456
|
64
|
66
|
1,553
|
65
|
73
|
10) Table 35: Q4 2021 - Product Sales quarterly sequential
analysis[80]
The sequential quarterly Product Sales information included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
|
|
|
Q1 2021
|
|
|
Q2 2021
|
|
|
Q3 2021
|
|
|
Q4 2021
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Oncology
|
2,981
|
3
|
1
|
3,286
|
10
|
11
|
3,326
|
1
|
2
|
3,455
|
4
|
5
|
Tagrisso
|
1,149
|
(1)
|
(3)
|
1,306
|
14
|
14
|
1,247
|
(5)
|
(4)
|
1,314
|
5
|
6
|
Imfinzi
|
556
|
-
|
(1)
|
604
|
9
|
10
|
618
|
2
|
3
|
634
|
3
|
4
|
Lynparza
|
543
|
9
|
8
|
588
|
8
|
9
|
588
|
-
|
1
|
629
|
7
|
8
|
Calquence
|
209
|
15
|
15
|
280
|
34
|
34
|
354
|
26
|
26
|
395
|
12
|
12
|
Koselugo
|
21
|
23
|
23
|
26
|
23
|
22
|
26
|
-
|
2
|
34
|
27
|
27
|
Enhertu
|
1
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
5
|
64
|
63
|
7
|
42
|
41
|
Orpathys
|
-
|
-
|
-
|
-
|
-
|
-
|
10
|
n/m
|
n/m
|
6
|
(39)
|
(40)
|
Zoladex
|
221
|
2
|
-
|
244
|
10
|
11
|
250
|
2
|
3
|
232
|
(7)
|
(5)
|
Faslodex
|
122
|
(6)
|
(8)
|
105
|
(14)
|
(12)
|
103
|
(2)
|
(2)
|
101
|
(1)
|
-
|
Iressa
|
61
|
(9)
|
(11)
|
47
|
(23)
|
(22)
|
41
|
(11)
|
(14)
|
35
|
(16)
|
(11)
|
Casodex
|
42
|
7
|
5
|
41
|
(2)
|
(1)
|
38
|
(7)
|
(8)
|
22
|
(42)
|
(38)
|
Arimidex
|
44
|
22
|
18
|
29
|
(34)
|
(33)
|
33
|
16
|
19
|
33
|
(2)
|
(7)
|
Others
|
12
|
(4)
|
(6)
|
13
|
13
|
11
|
13
|
(5)
|
(4)
|
13
|
(1)
|
1
|
BioPharmaceuticals: CVRM
|
1,912
|
4
|
1
|
2,023
|
6
|
6
|
2,082
|
3
|
3
|
2,003
|
(4)
|
(3)
|
Farxiga
|
624
|
6
|
4
|
732
|
17
|
18
|
796
|
9
|
9
|
848
|
7
|
9
|
Brilinta
|
374
|
3
|
1
|
375
|
-
|
1
|
375
|
-
|
1
|
348
|
(7)
|
(7)
|
Bydureon
|
103
|
(16)
|
(17)
|
95
|
(8)
|
(7)
|
95
|
1
|
2
|
91
|
(4)
|
(5)
|
Onglyza
|
101
|
(3)
|
(6)
|
99
|
(2)
|
(2)
|
84
|
(15)
|
(15)
|
75
|
(11)
|
(10)
|
Byetta
|
16
|
(14)
|
(15)
|
16
|
(4)
|
(7)
|
13
|
(15)
|
(7)
|
10
|
(21)
|
(22)
|
Other diabetes
|
13
|
7
|
1
|
15
|
14
|
14
|
14
|
(9)
|
(4)
|
17
|
21
|
17
|
Roxadustat
|
39
|
n/m
|
n/m
|
51
|
32
|
32
|
55
|
7
|
7
|
30
|
(45)
|
(46)
|
Lokelma
|
33
|
16
|
18
|
39
|
21
|
21
|
49
|
25
|
26
|
54
|
9
|
10
|
Crestor
|
274
|
(8)
|
(9)
|
265
|
(3)
|
(3)
|
298
|
12
|
13
|
259
|
(13)
|
(12)
|
Seloken/Toprol-XL
|
250
|
25
|
21
|
266
|
6
|
7
|
234
|
(12)
|
(13)
|
202
|
(13)
|
(13)
|
Atacand
|
34
|
(45)
|
(45)
|
23
|
(35)
|
(32)
|
19
|
(15)
|
(18)
|
21
|
9
|
8
|
Others
|
51
|
12
|
10
|
47
|
(7)
|
(10)
|
50
|
6
|
7
|
48
|
(4)
|
(4)
|
BioPharmaceuticals: Respiratory & Immunology
|
1,541
|
1
|
(1)
|
1,420
|
(8)
|
(7)
|
1,483
|
4
|
5
|
1,590
|
7
|
8
|
Symbicort
|
691
|
2
|
-
|
680
|
(2)
|
(1)
|
676
|
(1)
|
-
|
681
|
1
|
1
|
Fasenra
|
260
|
(8)
|
(9)
|
320
|
23
|
23
|
322
|
1
|
1
|
357
|
11
|
12
|
Pulmicort
|
330
|
(10)
|
(13)
|
167
|
(50)
|
(49)
|
217
|
30
|
30
|
248
|
14
|
15
|
Daliresp
|
60
|
11
|
10
|
54
|
(10)
|
(9)
|
54
|
-
|
(2)
|
59
|
9
|
10
|
Breztri
|
27
|
n/m
|
n/m
|
56
|
n/m
|
n/m
|
47
|
(15)
|
(15)
|
73
|
54
|
55
|
Bevespi
|
13
|
7
|
8
|
13
|
1
|
3
|
13
|
(1)
|
(2)
|
15
|
15
|
18
|
Saphnelo
|
-
|
-
|
-
|
-
|
-
|
-
|
1
|
n/m
|
n/m
|
7
|
n/m
|
n/m
|
Others
|
160
|
28
|
25
|
130
|
(19)
|
(19)
|
153
|
17
|
19
|
150
|
(2)
|
(2)
|
Rare Disease‡
|
-
|
-
|
-
|
-
|
-
|
-
|
1,311
|
(2)
|
(1)
|
1,759
|
4
|
6
|
Soliris‡
|
-
|
-
|
-
|
-
|
-
|
-
|
798
|
(6)
|
(4)
|
1,076
|
4
|
7
|
Ultomiris‡
|
-
|
-
|
-
|
-
|
-
|
-
|
297
|
7
|
8
|
391
|
4
|
5
|
Strensiq‡
|
-
|
-
|
-
|
-
|
-
|
-
|
159
|
(2)
|
(2)
|
219
|
8
|
9
|
Andexxa‡
|
-
|
-
|
-
|
-
|
-
|
-
|
29
|
5
|
6
|
39
|
1
|
-
|
Kanuma‡
|
-
|
-
|
-
|
-
|
-
|
-
|
28
|
9
|
9
|
34
|
(7)
|
(4)
|
Other medicines
|
548
|
(25)
|
(26)
|
454
|
(17)
|
(16)
|
539
|
19
|
20
|
825
|
53
|
55
|
Nexium
|
403
|
7
|
5
|
336
|
(17)
|
(15)
|
259
|
(23)
|
(23)
|
328
|
27
|
31
|
Synagis
|
24
|
(69)
|
(69)
|
24
|
1
|
1
|
122
|
n/m
|
n/m
|
239
|
97
|
98
|
FluMist
|
2
|
(99)
|
(99)
|
1
|
(51)
|
(71)
|
72
|
n/m
|
n/m
|
178
|
n/m
|
n/m
|
Losec/Prilosec
|
54
|
39
|
36
|
46
|
(14)
|
(15)
|
38
|
(18)
|
(17)
|
41
|
9
|
11
|
Seroquel XR/IR
|
29
|
51
|
38
|
21
|
(29)
|
(22)
|
24
|
17
|
14
|
19
|
(22)
|
(23)
|
Others
|
36
|
(6)
|
(4)
|
26
|
(28)
|
(32)
|
24
|
(8)
|
(5)
|
20
|
(16)
|
(17)
|
COVID-19
|
275
|
n/m
|
n/m
|
862
|
n/m
|
n/m
|
1,000
|
16
|
18
|
1,866
|
87
|
88
|
Vaxzevria
|
275
|
n/m
|
n/m
|
862
|
n/m
|
n/m
|
1,000
|
16
|
18
|
1,781
|
78
|
79
|
Evusheld
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
85
|
n/m
|
n/m
|
Total Product Sales
|
7,257
|
4
|
1
|
8,045
|
11
|
12
|
9,741
|
21
|
22
|
11,498
|
18
|
19
|
11) Table 36: FY 2020 - Product Sales quarterly sequential
analysis[81]
The sequential quarterly Product Sales information included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
|
Q1 2020
|
Q2 2020
|
Q3 2020
|
Q4 2020
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
Oncology
|
2,502
|
10
|
10
|
2,609
|
4
|
6
|
2,831
|
8
|
6
|
2,908
|
3
|
2
|
Tagrisso
|
982
|
11
|
11
|
1,034
|
5
|
7
|
1,155
|
12
|
9
|
1,157
|
-
|
(1)
|
Imfinzi
|
462
|
9
|
9
|
492
|
6
|
8
|
533
|
8
|
6
|
555
|
4
|
3
|
Lynparza
|
397
|
13
|
13
|
419
|
5
|
7
|
464
|
11
|
8
|
496
|
7
|
6
|
Calquence
|
88
|
58
|
58
|
107
|
21
|
23
|
145
|
36
|
35
|
182
|
25
|
25
|
Koselugo
|
-
|
-
|
-
|
7
|
n/m
|
n/m
|
13
|
75
|
75
|
17
|
34
|
34
|
Zoladex
|
225
|
15
|
15
|
217
|
(3)
|
-
|
230
|
6
|
3
|
216
|
(6)
|
(7)
|
Faslodex
|
166
|
-
|
-
|
146
|
(12)
|
(9)
|
138
|
(5)
|
(8)
|
130
|
(6)
|
(7)
|
Iressa
|
77
|
(3)
|
(4)
|
70
|
(9)
|
(7)
|
54
|
(23)
|
(24)
|
67
|
24
|
19
|
Arimidex
|
50
|
(1)
|
(2)
|
58
|
17
|
16
|
42
|
(28)
|
(27)
|
36
|
(14)
|
(16)
|
Casodex
|
42
|
(2)
|
(3)
|
47
|
14
|
12
|
44
|
(7)
|
(8)
|
39
|
(11)
|
(14)
|
Others
|
13
|
(52)
|
(52)
|
12
|
(11)
|
(1)
|
13
|
4
|
3
|
13
|
2
|
2
|
BioPharmaceuticals: CVRM
|
1,701
|
(5)
|
(5)
|
1,759
|
3
|
6
|
1,794
|
2
|
-
|
1,842
|
3
|
1
|
Farxiga
|
405
|
(3)
|
(3)
|
443
|
9
|
13
|
525
|
19
|
16
|
586
|
11
|
10
|
Brilinta
|
408
|
(5)
|
(5)
|
437
|
7
|
9
|
385
|
(12)
|
(13)
|
363
|
(6)
|
(6)
|
Onglyza
|
141
|
8
|
8
|
115
|
(19)
|
(17)
|
110
|
(6)
|
(6)
|
105
|
(4)
|
(5)
|
Bydureon
|
100
|
(28)
|
(28)
|
116
|
16
|
17
|
109
|
(5)
|
(7)
|
122
|
12
|
11
|
Byetta
|
20
|
(24)
|
(24)
|
15
|
(28)
|
(28)
|
15
|
1
|
4
|
19
|
26
|
24
|
Other diabetes
|
13
|
(22)
|
(22)
|
10
|
(21)
|
(19)
|
11
|
9
|
6
|
12
|
11
|
15
|
Lokelma
|
11
|
42
|
42
|
17
|
56
|
58
|
21
|
22
|
26
|
28
|
37
|
28
|
Crestor
|
301
|
2
|
1
|
281
|
(7)
|
(4)
|
300
|
7
|
5
|
298
|
(1)
|
(4)
|
Seloken/Toprol-XL
|
177
|
(6)
|
(6)
|
218
|
23
|
27
|
225
|
4
|
3
|
200
|
(11)
|
(13)
|
Atacand
|
66
|
11
|
12
|
59
|
(11)
|
(5)
|
54
|
(9)
|
(12)
|
63
|
16
|
14
|
Others
|
59
|
(21)
|
(22)
|
48
|
(18)
|
(16)
|
39
|
(19)
|
(22)
|
46
|
18
|
17
|
BioPharmaceuticals: Respiratory & Immunology
|
1,551
|
1
|
1
|
1,117
|
(28)
|
(26)
|
1,161
|
4
|
1
|
1,528
|
32
|
29
|
Symbicort
|
790
|
11
|
11
|
653
|
(17)
|
(15)
|
599
|
(8)
|
(11)
|
680
|
13
|
13
|
Pulmicort
|
380
|
(8)
|
(9)
|
97
|
(74)
|
(73)
|
151
|
56
|
49
|
368
|
n/m
|
n/m
|
Fasenra
|
199
|
(3)
|
(3)
|
227
|
14
|
15
|
240
|
5
|
4
|
283
|
18
|
17
|
Daliresp
|
53
|
(8)
|
(8)
|
53
|
(1)
|
(3)
|
57
|
8
|
11
|
54
|
(4)
|
(6)
|
Bevespi
|
12
|
9
|
9
|
10
|
(19)
|
(21)
|
14
|
47
|
46
|
12
|
(16)
|
(17)
|
Breztri
|
4
|
n/m
|
n/m
|
7
|
58
|
64
|
10
|
45
|
48
|
6
|
(39)
|
(38)
|
Others
|
113
|
(16)
|
(17)
|
70
|
(38)
|
(36)
|
90
|
27
|
22
|
125
|
39
|
35
|
Other medicines
|
557
|
(15)
|
(15)
|
563
|
1
|
4
|
734
|
30
|
27
|
733
|
-
|
(2)
|
Nexium
|
338
|
(4)
|
(4)
|
377
|
12
|
14
|
401
|
6
|
4
|
377
|
(6)
|
(7)
|
Synagis
|
85
|
35
|
35
|
90
|
6
|
7
|
118
|
31
|
29
|
78
|
(34)
|
(33)
|
FluMist
|
-
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
116
|
n/m
|
n/m
|
179
|
55
|
50
|
Losec/Prilosec
|
54
|
18
|
17
|
45
|
(15)
|
(15)
|
45
|
-
|
-
|
39
|
(15)
|
(18)
|
Seroquel XR/IR
|
36
|
(12)
|
(12)
|
27
|
(26)
|
(23)
|
35
|
32
|
29
|
19
|
(45)
|
(42)
|
Others
|
44
|
(71)
|
(70)
|
24
|
(46)
|
(42)
|
19
|
(17)
|
(19)
|
41
|
n/m
|
n/m
|
Total Product Sales
|
6,311
|
1
|
1
|
6,048
|
(4)
|
(2)
|
6,520
|
8
|
6
|
7,011
|
8
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 37: Collaboration Revenue
|
|
FY 2021
|
FY 2020
|
FY 2019
|
|
|
$m
|
$m
|
$m
|
Initial Collaboration Revenue
|
|
|
|
|
Nexium (Japan)
|
|
75
|
-
|
-
|
Ongoing Collaboration Revenue
|
|
|
|
|
Lynparza: regulatory
milestones
|
|
-
|
160
|
60
|
Lynparza: sales
milestones
|
|
400
|
300
|
450
|
Lynparza/Koselugo: option payments
|
|
-
|
-
|
100
|
Crestor (Spain)
|
|
-
|
-
|
39
|
Enhertu: share of gross
profits
|
|
193
|
94
|
-
|
Roxadustat: share of gross profits
|
|
6
|
30
|
-
|
Royalty income
|
|
138
|
62
|
62
|
Other Ongoing Collaboration Revenue
|
|
64
|
81
|
108
|
Total
|
|
876
|
727
|
819
|
Table 38: Other Operating Income and Expense
The table below provides an analysis of Reported Other Operating
Income and Expense.
|
|
FY 2021
|
FY 2020
|
FY 2019
|
|
$m
|
$m
|
$m
|
Divestment of Viela Bio, Inc. shareholding
|
|
776
|
-
|
-
|
Crestor (Europe ex-UK and
Spain)
|
|
317
|
-
|
-
|
Late stage small-molecule antibiotics assets (ex-US)
|
|
100
|
-
|
75
|
Hypertension medicines (ex-US, India and Japan)
|
|
-
|
350
|
-
|
Monetisation of an asset previously licensed
|
|
-
|
120
|
-
|
Brazikumab licence termination funding
|
|
99
|
107
|
-
|
Inderal, Tenormin, Seloken and Omepral (Japan)
|
|
-
|
51
|
-
|
Synagis (US)
|
|
-
|
-
|
515
|
Losec (ex-China, Japan, US
and Mexico)
|
|
-
|
-
|
243
|
Seroquel and Seroquel XR (US, Canada, Europe and
Russia)
|
|
-
|
-
|
213
|
Arimidex and Casodex (various countries)
|
|
-
|
-
|
181
|
Nexium (Europe)
and Vimovo (ex-US)
|
|
-
|
54
|
-
|
Atacand
|
|
-
|
400
|
-
|
Other
|
|
200
|
446
|
314
|
Total
|
|
1,492
|
1,528
|
1,541
|
Financial calendar and other shareholder information
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); Atacand, owned by AstraZeneca or Cheplapharm (depending
on geography); Duaklir and Eklira, trademarks of Almirall,
S.A.; Enhertu, a trademark of Daiichi
Sankyo; Inderal and Tenormin, owned by AstraZeneca, Atnahs Pharma and Taiyo
Pharma Co. Ltd. (depending upon
geography); Losec and Omepral,
owned by AstraZeneca, Cheplapharm or Taiyo Pharma Co., Ltd
(depending on geography); Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd
(depending on geography); Synagis, owned by AstraZeneca or AbbVie Inc. (depending
on geography); Tezspire, a trademark of Amgen,
Inc.; Vimovo, owned by AstraZeneca or Grünenthal GmbH
(depending on geography).
Information on or accessible through AstraZeneca's websites,
including astrazeneca.com,
does not form part of and is not incorporated into this
announcement.
Announcement of first quarter results:
29 April
2022
Announcement of half year and second quarter results
29
July 2022
Announcement of year to date and third quarter results
10 November
2022
Dividends are normally be paid as follows:
First interim:
Announced with the half-year and second-quarter results and paid in
September
Second interim: Announced with full-year and
fourth-quarter results and paid in March
The record date for the second interim dividend for 2021, payable
on 28 March 2022, will be 25 February 2022. The ex-dividend date
will be 24 February 2022.
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
|
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|
|
db@astfinancial.com
|
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 risk of failure in financial control or the occurrence of
fraud
-
the risk of unexpected deterioration in the Group's financial
position
-
the impact that the COVID-19 global pandemic 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
Nothing in this document, or any related presentation/webcast,
should be construed as a profit forecast.
- End of document -
[19] Systemic lupus
erythematosus.
[20] Committee for
Medicinal Products for Human Use.
[21] A breast cancer gene
mutation.
[22] Human epidermal
growth factor receptor 2 positive.
[23] Non-small cell lung
cancer.
[24] Neurofibromatosis
type 1 (NF1) plexiform neurofibromas (PN).
[25] Paroxysmal nocturnal
haemoglobinuria.
[26] Atypical haemolytic
uraemic syndrome.
[27] Generalised
myasthenia gravis.
[28] Hereditary amyloid
transthyretin polyneuropathy,
[29] Transthyretin amyloid
cardiomyopathy.
[30] Heart failure with
preserved ejection fraction.
[31] Neuromyelitis optica
spectrum disorder.
[32] Epidermal growth
factor receptor mutation.
[33] Small cell lung
cancer.
[34] Chronic lymphocytic
leukaemia.
[35] Mantle cell
lymphoma.
[36] Hyper-eosinophilic
syndrome.
[37] Eosinophilic
oesophagitis.
[38] Muscle
invasive.
[39] Hepatocellular
carcinoma.
[40] Colorectal
cancer.
[41] Human epidermal
growth factor receptor 2 over expressing.
[42] Triple negative
breast cancer.
[43] Myelodysplastic
syndrome.
[44] Eosinophilic
granulomatosis with polyangiitis.
[45] Chronic
rhinosinusitis with nasal polyps.
[46] Over the
counter.
[47] Substitution of
threonine (T) with methionine (M) at position 790 of exon 20
mutation.
[48] Chemoradiation
therapy.
[49] Extensive stage
non-small cell lung cancer.
[50] Poly ADP ribose
polymerase.
[51] Homologous
recombination repair gene mutation.
[52] A targetable gene
alteration found in NSCLC.
[53] Sodium-glucose
co-transporter-2.
[54] Type-2
diabetes.
[55] An enzyme that
destroys the hormone incretin.
[56] Inhaled
corticosteroid.
[57] Long-acting
beta-agonist.
[58] Chronic obstructive
pulmonary disease.
[59] Respiratory syncytial
virus.
[60] In Q3 2021 following
the acquisition of Alexion, a new column was introduced to present
acquisition-related non-core items, primarily unwind of fair value
uplift on inventories and acquisition costs.
[61] In previous quarters
a separate column had been included for items pertaining to the
Diabetes Alliance between AstraZeneca and Bristol-Myers Squibb
Company (BMS). From Q3 2021, this column has been removed with
amounts now presented in the Intangible Asset Amortisation &
Impairments and the Other column as applicable.
[62] Core financial
measures are adjusted to exclude certain items. For more
information on the Reported to Core financial adjustments, please
refer to the Operating and financial review.
[63] Based on best
prevailing assumptions around currency
profiles.
[64] Based on average
daily spot rates in FY 2021.
[65] Based on average
daily spot rates from 1 January 2022 to 31 January
2022.
[66] Other currencies
include AUD, BRL, CAD, KRW and RUB.
[67] These priorities were
determined through a materiality assessment conducted in 2018 with
a broad range of external and internal stakeholders, respectively.
Combined, they ensure the maximum possible benefit to patients, the
Company, broader society and the planet. AstraZeneca's
sustainability priorities align with the United Nations
Sustainable
Development Goals (SDG), and, in particular, SDG
three for 'Good Health'.
[68] Overall
survival.
[69] Single tremelimumab
regular interval durvalumab.
[70] Overall response
rate.
[71] Duration of
response.
[72] Angiotensin-converting enzyme
inhibitor.
[73] Angiotensin-receptor
blockers.
[74] US Food and Drug
Administration.
[75] Intramuscular
injection.
[76] The same weighted
average number of shares was used for the calculation of basic and
diluted loss per share in the quarter as the effect of potentially
dilutive shares outstanding was anti-dilutive
[77] As part of the
acquisition of Alexion in July 2021, a pre-existing non-controlling
interest in Caelum Biosciences, Inc. was recognised. This was
valued at $150m, the agreed upon exercise price for the exclusive
option to acquire the remaining equity. The option was exercised on
28 September 2021 and the acquisition of Caelum Biosciences closed
shortly
thereafter on 5 October 2021. Further details are
included in Note 5, Acquisition of
Alexion.
[78] 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.
*Growth rates on Rare Disease medicines have been calculated by
comparing post-acquisition revenues from 21 July 2021 with
the
corresponding prior year pre-acquisition revenues
previously published by Alexion adjusted pro rata to match the
post-acquisition period.
[79] 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. †Growth
rates on Rare Disease medicines have been calculated by comparing
post-acquisition revenues from 1 October 2021
with
the corresponding prior year pre-acquisition Q4
revenues previously published by
Alexion.
[80] The table provides an
analysis of sequential quarterly Product Sales, with Actual and CER
growth rates reflecting quarter-on-quarter growth. Due to rounding,
the sum of a number of dollar values and percentages may not agree
to totals. ‡ Sequential
growth rates on Rare Disease medicines have been calculated by
comparing post-acquisition Q4 revenues
with the prior quarter
Q3.
[81] The
table provides an analysis of sequential quarterly Product Sales,
with actual and CER growth rates reflecting quarter-on-quarter
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:
10 February 2022
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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