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 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZN: full-year 2020 results
AstraZeneca PLC
11 February 2021 07:00 GMT
Full-year 2020 results
Accelerating the scientific and commercial evolution; 2021 guidance
shows continuing progress
AstraZeneca delivered strong results in the year, in line with
guidance that was reconfirmed during the year. With over half of
Total Revenue coming from the fast-growing new
medicines1,
the Company leveraged its revenue growth to make further progress
in profitability, while the strategy of sustainable growth through
innovation brought numerous further benefits for patients.
AstraZeneca's patient-centric strategy, focus on innovation and
capital-allocation priorities remain unchanged, with sustainable
long-term growth in revenue, profit and cash generation set to
continue.
Pascal Soriot, Chief Executive Officer, commented:
"The performance last year marked a significant step forward for
AstraZeneca. Despite the significant impact from the pandemic, we
delivered double-digit revenue growth to leverage improved
profitability and cash generation. The consistent achievements in
the pipeline, the accelerating performance of our business and the
progress of the COVID-19 vaccine demonstrated what we can achieve,
while the proposed acquisition of Alexion is intended to accelerate
our scientific and commercial evolution even further.
Additional investment in new medicines continued to fuel our
rapidly growing oncology and biopharmaceuticals therapy
areas. Tagrisso's future was enhanced with its first regulatory
approval in early, potentially-curable lung cancer and further
national reimbursement in China in advanced
disease. Farxiga again expanded its potential beyond
diabetes, while tezepelumab promised real hope for patients
suffering from severe asthma. Thanks to the focus on an
industry-leading pipeline and consistent execution, I am confident
that we will continue to deliver more progress for patients and
sustained, compelling results."
Table 1: Financial summary
|
FY 2020
|
Q4 2020
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER2
|
Actual
|
CER
|
Total Revenue
|
26,617
|
9
|
10
|
7,410
|
11
|
10
|
- Product
Sales
|
25,890
|
10
|
11
|
7,011
|
12
|
11
|
- Collaboration
Revenue
|
727
|
(11)
|
(11)
|
399
|
(4)
|
(4)
|
|
|
|
|
|
|
|
Reported3 EPS4
|
$2.44
|
n/m5
|
n/m
|
$0.78
|
n/m
|
n/m
|
Core6 EPS
|
$4.02
|
15
|
18
|
$1.07
|
19
|
24
|
Highlights of Total Revenue in the year included:
An increase in Product Sales of 10% (11% at CER) to $25,890m. The
quarter was the first for many years with Product Sales in excess
of $7,000m. New-medicine Total Revenue improved by 33% in the year
to $13,950m, including growth in Emerging Markets of 53% (59% at
CER) to $2,845m. Globally, the new medicines represented 52% of
Total Revenue (FY 2019: 43%)
Oncology growth of 23% (24% at CER) to $11,455m, while New
CVRM7 increased
by 7% (9% at CER) to $4,702m. Respiratory & Immunology declined
by 1% (stable at CER) to $5,375m, a reflection of the impact in
China of COVID-19
An increase in Emerging Markets of 7% (10% at CER) to $8,711m, with
China growth of 10% (11% at CER) to $5,375m. In the US, Total
Revenue increased by 13% to $8,833m and in Europe by 10% (9% at
CER) to $5,540m. Both regions delivered stronger growth rates in
the final quarter compared to the full year - see the Regional
Total Revenue section for details
Guidance
The Company provides guidance for FY 2021 at CER.
Total Revenue is expected to increase by a low-teens
percentage,
accompanied by faster growth in Core EPS to $4.75 to
$5.00.
The guidance does not incorporate any revenue or profit impact from
sales of COVID-19 Vaccine
AstraZeneca (C19VAZ). The Company intends to report these sales
separately from the next quarter. Similarly, the guidance excludes
the proposed acquisition by the Company of Alexion Pharmaceuticals,
Inc. (Alexion), anticipated to close in Q3 2021. AstraZeneca
recognises the heightened risks and uncertainties from the impact
of COVID-19. Variations in performance between quarters can be
expected to continue.
The Company is unable to provide guidance and indications 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.
Indications
The Company provides indications for FY 2021 at CER:
-
AstraZeneca continues its focus on improving operating leverage,
while addressing its most important capital-allocation priority of
re-investment in the business, namely continued investment in
R&D and the support of medicines and patient access in key
markets
-
A Core Tax Rate of 18-22%. Variations in the Core Tax Rate between
quarters are anticipated to continue
Currency impact
If foreign-exchange rates for January 2021 were seen over the full
year, it is anticipated that there would be a low single-digit
favourable impact on Total Revenue and Core EPS. The Company's
foreign-exchange rate sensitivity analysis is contained within the
operating and financial review.
Financial summary
- Total Revenue,
comprising Product Sales and Collaboration Revenue, increased by 9%
in the year (10% at CER) to $26,617m. Product Sales grew by 10%
(11% at CER) to $25,890m, driven primarily by the performances of
the new medicines across Oncology and BioPharmaceuticals,
including Tagrisso and Farxiga. Total Revenue included $2m
of C19VAZ Product Sales within Other medicines; from
the next quarter, AstraZeneca intends to report
the C19VAZ sales performance
separately
- The Reported Gross
Profit8 Margin
was stable (up by one percentage point at CER) at 80%, while the
Core Gross Profit Margin was stable, also at 80%, in line with the
Company's expectations
-
Reported Total Operating Expense declined by 2% in the year to
$17,684m and represented 66% of Total Revenue (FY 2019: 74%). Core
Total Operating Expense increased by 6% to $15,633m and comprised
59% of Total Revenue (FY 2019: 60%)
- Reported R&D Expense
declined by 1% in the year to $5,991m, primarily reflecting the
comparative effect of the $533m impairment
of Epanova in FY 2019. Core R&D Expense increased
by 10% to $5,872m, representing 22% of Total Revenue (FY 2019:
22%). The increases partly reflected investment in the Oncology
pipeline, including the development of datopotamab deruxtecan
(DS-1062), and the ending in FY 2019 of the release of the upfront
funding of Lynparza development, as part of
the collaboration with
MSD9
-
Reported SG&A Expense declined by 3% in the year to $11,294m;
Core SG&A Expense increased by 3% (4% at CER) to $9,362m,
representing 35% of Total Revenue (FY 2019: 37%). The difference in
the movements partly reflected fair-value adjustments arising on
acquisition-related liabilities, as well as an increase in legal
provisions recognised in 2019
-
Reported Other Income and Expense declined by 1% in the year to
$1,528m. Core Other Income and Expense fell by 2% to
$1,531m
-
The Reported Operating Profit Margin increased by seven percentage
points in the year (eight at CER) to 19%. The Core Operating Profit
Margin increased by one percentage point (two at CER) to 28% and
AstraZeneca anticipates further sustainable expansion in the Core
Operating Profit Margin over time
-
Reported EPS of $2.44 in the year represented an increase of 137%
(142% at CER). Core EPS grew by 15% (18% at CER) to
$4.02
-
The Board has reaffirmed its commitment to the progressive dividend
policy. A stable second interim dividend of $1.90 per share has
been declared, keeping the unchanged full-year dividend per share
at $2.80
-
Net Cash Inflow from Operating Activities of $4,799m in the year, a
year-on-year increase of $1,830m, primarily reflected an underlying
improvement in business performance and declines in Working Capital
and Short-Term Provisions. EBITDA progression continued, with
growth of 24% (27% at CER) in the year to $8,311m, while Net
Debt of $12,110m represented an increase of $206m
Commercial summary
Oncology
Total Revenue increased by 23% in the year (24% at CER) to
$11,455m.
Table 2: Select Oncology medicine performances
|
FY 2020
|
Q4 2020
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Tagrisso: Product
Sales
|
4,328
|
36
|
36
|
1,157
|
31
|
28
|
Imfinzi: Product
Sales
|
2,042
|
39
|
39
|
555
|
31
|
29
|
Lynparza: Product
Sales
|
1,776
|
48
|
49
|
496
|
42
|
40
|
Lynparza: Collaboration
Revenue
|
460
|
(25)
|
(25)
|
325
|
(7)
|
(7)
|
Calquence: Product
Sales
|
522
|
n/m
|
n/m
|
182
|
n/m
|
n/m
|
Enhertu: Collaboration
Revenue
|
96
|
n/m
|
n/m
|
33
|
n/m
|
n/m
|
New CVRM
Total Revenue increased by 7% in the year (9% at CER) to
$4,702m.
Table 3: Select New CVRM medicine performances
|
FY 2020
|
Q4 2020
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Farxiga: Total
Revenue
|
1,964
|
27
|
30
|
587
|
40
|
40
|
Brilinta: Product
Sales
|
1,593
|
1
|
2
|
363
|
(15)
|
(15)
|
Bydureon: Product
Sales
|
448
|
(18)
|
(18)
|
122
|
(12)
|
(12)
|
Lokelma: Product
Sales
|
76
|
n/m
|
n/m
|
28
|
n/m
|
n/m
|
Roxadustat: Collaboration Revenue
|
30
|
n/m
|
n/m
|
11
|
n/m
|
n/m
|
Respiratory & Immunology
Total Revenue declined by 1% in the year (stable at CER) to
$5,375m. The adverse impact of the decline
in Pulmicort sales reduced Respiratory & Immunology
Total Revenue growth by 12 percentage points.
Table 4: Select Respiratory & Immunology medicine
performances
|
FY 2020
|
Q4 2020
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Symbicort: Product
Sales
|
2,721
|
9
|
10
|
680
|
(5)
|
(5)
|
Pulmicort: Product
Sales
|
996
|
(32)
|
(32)
|
368
|
(11)
|
(14)
|
Fasenra: Product
Sales
|
949
|
35
|
34
|
283
|
38
|
35
|
Breztri: Product
Sales
|
28
|
n/m
|
n/m
|
6
|
n/m
|
n/m
|
Emerging Markets
Total Revenue increased by 7% in the year (10% at CER) to $8,711m,
including:
- A China increase of 10%
(11% at CER) to $5,375m. The strong performance was limited by the
adverse impacts of COVID-19 on sales of Pulmicort and the pricing effect of the China
volume-based procurement (VBP) programme
on Brilinta,
Losec and Arimidex. The Company continued to prioritise patient
access to its medicines and geographical expansion in the Chinese
market; this included additional successful inclusion of a number
of medicines on the National Reimbursement Drug List (NRDL).
Admission to the list has an immediate adverse impact on pricing;
typically, however, this is more than offset by a subsequent
favourable effect on volumes
-
An ex-China increase of 1% (9% at CER) to $3,336m, with
particularly strong performances in Russia and Latin
America
COVID-19
The ongoing pandemic has had a significant impact on every aspect
of life in 2020, and the Company recognises the outstanding
contribution of colleagues at AstraZeneca and their unrelenting
focus on improving the lives of patients. The largest direct
impacts of COVID-19 on the Company's portfolio of medicines
included reduced sales of Pulmicort in China on fewer nebulisation-centre visits
and reduced elective surgery, and less use globally of infused and
injectable medicines, such as Imfinzi and Fasenra. There was also a decline in the number of
hospital admissions around the world for the treatment of heart
attacks and lower levels of elective percutaneous coronary
intervention10,
adversely impacting sales of Brilinta. Some medicines, however, may have benefited from
shifts in patient care and behaviours, including oral medicines
such as Calquence, which saw an element of benefit from the
substitution from infused-chemotherapy
regimens.
AstraZeneca has collaborated to mobilise research efforts to target
the SARS-CoV-2 virus, in order to provide protection to societies
and people against COVID-19 and to treat patients with severe
disease. C19VAZ, developed in collaboration with the University
of Oxford, received authorisation in December 2020 for emergency
supply from the UK Medicines and Healthcare Products Regulatory
Agency (MHRA). Additional regulatory decisions have also been
granted by regulatory authorities in a number of individual
countries, including India, Argentina, Mexico and Morocco, and by
the European Medicines Agency (EMA). In February 2021, the World
Health Organization's (WHO) Strategic Advisory Group of Experts on
Immunization (SAGE) also recommended C19VAZ for use in individuals 18 years and over,
with a preferred dosing interval of eight to 12
weeks.
In addition to C19VAZ, the Company has initiated five Phase III
clinical trials of AZD7442, a long-acting antibody (LAAB)
combination therapy for the prevention and treatment of COVID-19,
to evaluate safety and efficacy in preventing infection and
treating patients in outpatient and inpatient settings. Further
details of the Company's broad COVID-19 research and development
programme are shown in the research and development section of this
announcement. Details of AstraZeneca's work with governments and
other organisations, including agreements on the supply
of C19VAZ, can be found in the comprehensive sustainability
section of this announcement.
Sustainability summary
During the period, the Company received recognition of its broad
sustainability efforts, featuring in the top five for the sector in
the Dow Jones
Sustainability Index (DJSI) and
inclusion in the Corporate Knights
Global 100 Index, which
identifies globally sustainable companies.
Recent developments and progress against the Company's
sustainability priorities are reported below:
a) Access to healthcare
In December 2020, AstraZeneca, through an advanced-purchase
agreement with Gavi, the Vaccines Alliance, committed to enabling
access to 170m doses of C19VAZ in up to 190 countries worldwide, through
the COVAX Facility (COVAX). COVAX is a coalition co-led by CEPI,
the Coalition for Epidemic Preparedness Innovations, Gavi, and the
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.
b) Environmental protection
During the period, AstraZeneca was recognised for
its leadership in
sustainability by global
environmental non-profit CDP, a charity that runs a global
disclosure system for investors, companies, cities, states and
regions to manage their environmental impacts. The Company received
a place on the 'A List' for both climate action and water security.
AstraZeneca was one of only three organisations worldwide to
achieve this double A List recognition for five consecutive years.
The Company also featured among the top 7% on CDP's 2020 Supplier
Engagement Leaderboard, recognising progress in working with
suppliers to address their emissions.
c) Ethics and transparency
In January 2021, the Company was recognised for its efforts in
promoting inclusion and diversity by the Bloomberg Gender
Equality Index (BGEI),
which tracks the performance of public companies committed to
disclosing their efforts to support gender equality through policy
development, representation and transparency. The Company was also
listed as a participant in ShareAction's Workforce Disclosure
Initiative (WDI), an
annual survey that aims to improve corporate transparency and
accountability on workforce issues and provide companies and
investors with comprehensive and comparable data to help increase
the provision of good jobs worldwide.
A more extensive sustainability update is provided later in this
announcement.
Notes
The following notes refer to pages one to five.
1. Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new medicines are pillars in the three
therapy areas of Oncology, Cardiovascular (CV), Renal &
Metabolism (CVRM), and Respiratory & Immunology and are
important platforms for future growth. The Total Revenue
of Enhertu and roxadustat in the year entirely
reflected Collaboration Revenue.
2.
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.
3.
Reported financial measures are the financial results presented in
accordance with International Financial Reporting Standards (IFRS),
adopted pursuant to Regulation (EC) No 1606/2002 as it applies in
the EU and as issued by the International Accounting Standards
Board.
4.
Earnings per share.
5.
Not meaningful.
6.
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.
7. New CVRM
comprises Brilinta, Renal and Diabetes
medicines.
8.
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.
9. Merck
& Co., Inc., Kenilworth, NJ, US, known as MSD outside the US
and Canada.
10.
Percutaneous coronary intervention is a nonsurgical procedure
intended to improve blood flow to the heart.
Table 5: Pipeline highlights
The following table highlights significant developments in the
late-stage pipeline since the prior results
announcement:
Regulatory
approvals
|
- Tagrisso -
adjuvant[11] NSCLC[12] (EGFRm[13])
(US)
- Imfinzi -
new Q4W[14] dosing (US,
EU)
- Lynparza -
ovarian cancer (1st line[15], HRD+[16]) (PAOLA-1) (EU,
JP)
- Lynparza -
prostate cancer (2nd line, BRCAm[17]) (EU,
JP)
- Lynparza -
pancreatic cancer (1st line, BRCAm) (JP)
- Enhertu -
gastric cancer (2nd line+, HER2+[18])
(US)
- Enhertu -
breast cancer (3rd line, HER2+) (EU)
- Calquence -
CLL[19] (EU,
JP)
- Forxiga -
HF[20] CVOT[21] (EU,
JP, CN)
- Brilinta -
stroke (THALES) (US)
- Symbicort -
mild asthma (CN)
- Trixeo -
COPD[22] (EU)
- C19VAZ -
COVID-19 (UK; authorisation for emergency supply, EU; conditional
marketing authorisation)
|
Regulatory
submission acceptances and/or submissions
|
- Tagrisso -
adjuvant NSCLC (EGFRm) (EU)
- Lynparza
- prostate cancer (2nd line, BRCAm) (CN)
- Farxiga -
CKD[23] (US, JP;
priority reviews, EU, CN)
-
anifrolumab - lupus (SLE[24])
(JP)
|
Major
Phase III data readouts or other significant
developments
|
- Imfinzi -
biliary tract cancer: Orphan Drug Designation (US)
- Imfinzi +
treme[25] - head &
neck cancer (1st line): Phase III primary endpoint not
met
-
tremelimumab - liver cancer: orphan designation (EU)
- Calquence -
CLL (R/R[26]) (ELEVATE R/R):
Phase III primary endpoint met
-
tezepelumab - severe asthma: Phase III primary endpoint
met
|
Table 6: Pipeline - anticipated major news flow
Timing
|
News
flow
|
H1 2021
|
- Tagrisso -
adjuvant NSCLC (EGFRm): regulatory decision (CN)
- Imfinzi -
unresectable[27], Stage III NSCLC
(PACIFIC-2): data readout, regulatory submission
- Imfinzi +/-
treme - NSCLC (1st line) (POSEIDON): data readout (OS[28])
- Lynparza -
breast cancer (BRCAm): regulatory decision (CN)
- Lynparza -
adjuvant breast cancer: data readout
- Calquence -
CLL (R/R) (ELEVATE R/R): regulatory submission
- Koselugo -
NF1[29]:
regulatory decision (EU)
- Farxiga -
CKD: regulatory decision (US)
- Brilique/Brilinta -
CAD[30]/T2D[31] CVOT:
regulatory decision (EU, JP, CN)
- Brilique -
stroke (THALES): regulatory decision (EU)
-
roxadustat - anaemia in CKD: regulatory decision (US)
- Symbicort -
mild asthma: regulatory decision (EU)
- Fasenra -
nasal polyps[32]: regulatory
submission
-
tezepelumab - severe asthma: regulatory submission
- C19VAZ -
SARS-CoV-2: data readout, regulatory submission (US)
-
AZD7442 - SARS-CoV-2: data readout, regulatory
submission
|
H2 2021
|
- Tagrisso -
adjuvant NSCLC (EGFRm): regulatory decision (EU)
- Imfinzi -
NSCLC (1st line) (PEARL): data readout, regulatory
submission
- Imfinzi +/-
treme - NSCLC (1st line) (POSEIDON): regulatory
submission
- Imfinzi +/-
treme - liver cancer (1st line): data readout, regulatory
submission
- Lynparza -
adjuvant breast cancer: regulatory submission
- Lynparza
- prostate cancer (2nd line, BRCAm): regulatory
decision (CN)
- Lynparza -
prostate cancer (1st line, castration-resistant): data readout,
regulatory submission
- Enhertu -
breast cancer (3rd line, HER2+) (Phase III): data
readout
- Enhertu -
breast cancer (2nd line, HER2+): data readout, regulatory
submission
- Enhertu -
breast cancer (HER2 low[33]): data
readout
- Forxiga -
CKD: regulatory decision (EU, JP, CN)
- Farxiga -
HF (HFpEF[34]): data
readout
- Brilinta -
stroke (THALES): regulatory decision (CN)
-
PT027 - asthma: data readout
-
anifrolumab - lupus (SLE): regulatory decision (US, EU,
JP)
|
2022
|
- Imfinzi -
ES-SCLC[35]: regulatory
decision (CN)
- Imfinzi -
LS-SCLC[36]: data readout,
regulatory submission
- Imfinzi -
liver cancer (locoregional): data readout, regulatory
submission
- Imfinzi -
biliary tract cancer: data readout, regulatory
submission
- Lynparza -
ovarian cancer (3rd line, BRCAm): regulatory
submission
- Enhertu -
breast cancer (3rd line, HER2+) (Phase III): regulatory
submission
- Enhertu -
breast cancer (HER2 low): regulatory submission
- Calquence -
CLL: regulatory submission (CN)
- Koselugo -
NF1: regulatory submission (JP, CN)
- Farxiga -
HF (HFpEF): regulatory submission
-
roxadustat - MDS[37]: data readout,
regulatory submission
-
PT027 - asthma: regulatory submission
-
nirsevimab - RSV[38]: data
readout
|
Conference call
A conference call and webcast for investors and analysts will begin
at 11:45am UK time today. Details can be accessed
via astrazeneca.com.
Reporting calendar
The Company intends to publish its first-quarter results on Friday,
30 April 2021.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, CVRM, and Respiratory & Immunology. Based in
Cambridge, UK, AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
For more information, 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 2020
(the year or FY 2020) and the three-month period to 31 December
2020 (the quarter, the fourth quarter or Q4 2020), compared to the
twelve-month period to 31 December 2019 (FY 2019) and the
three-month period to 31 December 2019 (Q4 2019) respectively,
unless stated otherwise.
Forward-looking statements in this announcement do not reflect the
impact of the performance of C19VAZ or the proposed acquisition by the Company
of Alexion, which is expected to close in Q3
2021.
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, will 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 comprising the Diabetes alliance[39],
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 80 of the Annual Report and Form
20-F Information 2019.
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.
Table 7: Total Revenue by therapy area
Specialty-care medicines comprise all Oncology
medicines, Brilinta, Lokelma, roxadustat and Fasenra. At 53% of Total Revenue (FY 2019: 48%),
specialty-care medicines increased by 21% in the year (22% at CER)
to $14,103m.
|
FY 2020
|
Q4 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
11,455
|
43
|
23
|
24
|
3,270
|
24
|
23
|
BioPharmaceuticals
|
10,077
|
38
|
3
|
4
|
2,786
|
3
|
2
|
- New CVRM
|
4,702
|
18
|
7
|
9
|
1,252
|
7
|
7
|
- Respiratory &
Immunology
|
5,375
|
20
|
(1)
|
-
|
1,534
|
(1)
|
(2)
|
Other
medicines
|
5,085
|
19
|
(4)
|
(2)
|
1,354
|
3
|
2
|
|
|
|
|
|
|
|
|
Total
|
26,617
|
100
|
9
|
10
|
7,410
|
11
|
10
|
Table 8: Top-ten medicines by Total Revenue
Medicine
|
Therapy Area
|
FY 2020
|
Q4 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Tagrisso
|
Oncology
|
4,328
|
16
|
36
|
36
|
1,157
|
31
|
28
|
Symbicort
|
Respiratory & Immunology
|
2,721
|
10
|
9
|
10
|
680
|
(5)
|
(5)
|
Lynparza
|
Oncology
|
2,236
|
8
|
24
|
24
|
821
|
17
|
16
|
Imfinzi
|
Oncology
|
2,042
|
8
|
39
|
39
|
555
|
31
|
29
|
Farxiga
|
CVRM
|
1,964
|
7
|
27
|
30
|
587
|
40
|
40
|
Brilinta
|
CVRM
|
1,593
|
6
|
1
|
2
|
363
|
(15)
|
(16)
|
Nexium
|
Other medicines
|
1,524
|
6
|
1
|
2
|
384
|
7
|
5
|
Crestor
|
CVRM
|
1,182
|
4
|
(10)
|
(9)
|
298
|
(9)
|
(10)
|
Pulmicort
|
Respiratory & Immunology
|
996
|
4
|
(32)
|
(32)
|
368
|
(11)
|
(14)
|
Fasenra
|
Respiratory & Immunology
|
949
|
4
|
35
|
34
|
283
|
38
|
35
|
|
|
|
|
|
|
|
|
|
Total
|
|
19,535
|
73
|
14
|
15
|
5,496
|
13
|
11
|
Table 9: Collaboration Revenue
|
FY 2020
|
Q4 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Lynparza: regulatory milestone
revenue
|
160
|
22
|
n/m
|
n/m
|
25
|
n/m
|
n/m
|
Lynparza: sales milestone
revenue
|
300
|
41
|
(33)
|
(33)
|
300
|
20
|
20
|
Enhertu: share of gross
profits
|
94
|
13
|
n/m
|
n/m
|
31
|
n/m
|
n/m
|
Roxadustat: share of gross profits
|
30
|
4
|
n/m
|
n/m
|
11
|
n/m
|
n/m
|
Other Ongoing Collaboration Revenue
|
143
|
20
|
(32)
|
(32)
|
32
|
(53)
|
(54)
|
|
|
|
|
|
|
|
|
Total
|
727
|
100
|
(11)
|
(11)
|
399
|
(4)
|
(4)
|
Other Collaboration Revenue included Zoladex, Farxiga, Eklira, Nexium OTC[40] and
other royalties. No Initial Collaboration Revenue was recorded in
the year.
Total Revenue
The performance of the Company's medicines is shown below, with a
geographical split of Product Sales shown in Note 7.
Table 10: Therapy area and medicine performance - FY
2020
Product Sales:
therapy area
|
Medicine
|
FY 2020
|
$m
|
% of total Product Sales
|
% change
|
Actual
|
CER
|
Oncology
|
Tagrisso
|
4,328
|
17
|
36
|
36
|
Imfinzi
|
2,042
|
8
|
39
|
39
|
Lynparza
|
1,776
|
7
|
48
|
49
|
Calquence
|
522
|
2
|
n/m
|
n/m
|
Koselugo
|
38
|
-
|
n/m
|
n/m
|
Zoladex[41]
|
888
|
3
|
9
|
13
|
Faslodex41
|
580
|
2
|
(35)
|
(34)
|
Iressa41
|
268
|
1
|
(37)
|
(36)
|
Arimidex41
|
185
|
1
|
(18)
|
(16)
|
Casodex41
|
172
|
1
|
(14)
|
(14)
|
Others
|
51
|
-
|
(47)
|
(46)
|
Total Oncology
|
10,850
|
42
|
25
|
26
|
BioPharmaceuticals: CVRM
|
Farxiga
|
1,959
|
8
|
27
|
30
|
Brilinta
|
1,593
|
6
|
1
|
2
|
Onglyza
|
470
|
2
|
(11)
|
(10)
|
Bydureon
|
448
|
2
|
(18)
|
(18)
|
Byetta
|
68
|
-
|
(37)
|
(36)
|
Other diabetes
|
47
|
-
|
(10)
|
(10)
|
Lokelma
|
76
|
-
|
n/m
|
n/m
|
Crestor41
|
1,180
|
5
|
(8)
|
(7)
|
Seloken/Toprol-XL41
|
821
|
3
|
8
|
12
|
Atacand41
|
243
|
1
|
10
|
15
|
Others
|
191
|
1
|
(30)
|
(30)
|
BioPharmaceuticals:
total CVRM
|
7,096
|
27
|
3
|
5
|
BioPharmaceuticals: Respiratory & Immunology
|
Symbicort
|
2,721
|
11
|
9
|
10
|
Pulmicort
|
996
|
4
|
(32)
|
(32)
|
Fasenra
|
949
|
4
|
35
|
34
|
Daliresp/Daxas
|
217
|
1
|
1
|
1
|
Bevespi
|
48
|
-
|
16
|
15
|
Breztri
|
28
|
-
|
n/m
|
n/m
|
Others
|
398
|
2
|
(15)
|
(15)
|
BioPharmaceuticals: total Respiratory & Immunology
|
5,357
|
21
|
(1)
|
-
|
Other medicines
|
Nexium41
|
1,492
|
6
|
1
|
2
|
Synagis41
|
372
|
1
|
4
|
4
|
FluMist41
|
295
|
1
|
n/m
|
n/m
|
Losec/Prilosec41
|
183
|
1
|
(30)
|
(30)
|
Seroquel XR/IR41
|
117
|
-
|
(39)
|
(37)
|
Others
|
128
|
-
|
(33)
|
(34)
|
Total other medicines
|
2,587
|
10
|
(1)
|
-
|
|
Total Product Sales
|
25,890
|
100
|
10
|
11
|
Total Collaboration Revenue
|
727
|
|
(11)
|
(11)
|
Total Revenue
|
26,617
|
|
9
|
10
|
Table 11: Therapy area and medicine performance - Q4
2020
Product Sales:
therapy area
|
Medicine
|
Q4 2020
|
$m
|
% of total Product Sales
|
% change
|
Actual
|
CER
|
Oncology
|
Tagrisso
|
1,157
|
17
|
31
|
28
|
Imfinzi
|
555
|
8
|
31
|
29
|
Lynparza
|
496
|
7
|
42
|
40
|
Calquence
|
182
|
3
|
n/m
|
n/m
|
Koselugo
|
17
|
-
|
n/m
|
n/m
|
Zoladex
|
216
|
3
|
11
|
13
|
Faslodex
|
130
|
2
|
(21)
|
(22)
|
Iressa
|
67
|
1
|
(16)
|
(19)
|
Arimidex
|
36
|
1
|
(29)
|
(30)
|
Casodex
|
39
|
1
|
(10)
|
(13)
|
Others
|
13
|
-
|
(53)
|
(52)
|
Total Oncology
|
2,908
|
41
|
28
|
26
|
BioPharmaceuticals: CVRM
|
Farxiga
|
586
|
8
|
40
|
40
|
Brilinta
|
363
|
5
|
(15)
|
(15)
|
Onglyza
|
105
|
1
|
(20)
|
(21)
|
Bydureon
|
122
|
2
|
(12)
|
(12)
|
Byetta
|
19
|
-
|
(31)
|
(30)
|
Other diabetes
|
12
|
-
|
(23)
|
(22)
|
Lokelma
|
28
|
-
|
n/m
|
n/m
|
Crestor
|
298
|
4
|
1
|
(1)
|
Seloken/Toprol-XL
|
200
|
3
|
6
|
7
|
Atacand
|
63
|
1
|
5
|
9
|
Others
|
46
|
1
|
(38)
|
(40)
|
BioPharmaceuticals:
total CVRM
|
1,842
|
26
|
3
|
3
|
BioPharmaceuticals: Respiratory & Immunology
|
Symbicort
|
680
|
10
|
(5)
|
(5)
|
Pulmicort
|
368
|
5
|
(11)
|
(14)
|
Fasenra
|
283
|
4
|
38
|
35
|
Daliresp/Daxas
|
54
|
1
|
(6)
|
(7)
|
Bevespi
|
12
|
-
|
8
|
4
|
Breztri
|
6
|
-
|
n/m
|
n/m
|
Others
|
125
|
2
|
(8)
|
(12)
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,528
|
22
|
(1)
|
(2)
|
Other medicines
|
Nexium
|
377
|
5
|
7
|
6
|
Synagis
|
78
|
1
|
24
|
24
|
FluMist
|
179
|
3
|
92
|
85
|
Losec/Prilosec
|
39
|
1
|
(15)
|
(18)
|
Seroquel XR/IR
|
19
|
-
|
(53)
|
(49)
|
Others
|
41
|
1
|
(30)
|
(31)
|
Total other medicines
|
733
|
10
|
12
|
10
|
|
Total Product Sales
|
7,011
|
100
|
12
|
11
|
Total Collaboration Revenue
|
399
|
|
(4)
|
(4)
|
Total Revenue
|
7,410
|
|
11
|
10
|
Total Revenue summary
Oncology
Total Revenue of $11,455m in the year; an increase of 23% (24% at
CER). The performance of Enhertu was reflected entirely in Collaboration
Revenue.
Oncology represented 43% of overall Total Revenue (FY 2019:
38%).
Tagrisso
Tagrisso has received
regulatory approval in five countries, including the US, for use as
an adjuvant treatment of EGFRm NSCLC patients, with three
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 87 countries, including the US,
China, in the EU and Japan. To date, reimbursement has been granted
in 40 countries in this setting, with further decisions
anticipated. These developments followed Tagrisso's regulatory approval in 89 countries, including
the US, China, in the EU and Japan for the treatment of patients
with EGFR T790M[42] NSCLC,
an indication in which 66 reimbursements have been
obtained.
Total Revenue, entirely comprising Product Sales, amounted to
$4,328m in the year and represented growth of 36%. Sales in
the US increased by 24% to $1,566m. Approval was granted by the US
Food and Drug Administration (FDA) in December 2020 for the
adjuvant treatment of Stage Ib to IIIa EGFRm NSCLC
patients.
In Emerging Markets, Tagrisso sales increased by 59% in the year (63% at
CER) to $1,208m, with notable growth in China; admission to the
2021 China NRDL was obtained for the 1st-line and renewed for the
2nd-line setting, commencing in March 2021. Japan increased by 16%
(14% at CER) to $731m, despite a Q4 2019 price reduction of 15%. In
Europe, sales of $748m in the year represented an increase of 58%
(56% at CER), driven by use in the 1st-line setting, as more
reimbursements were granted.
Imfinzi
Imfinzi has received
regulatory approval in 67 countries, including the US, China, in
the EU and Japan for the treatment of patients with unresectable,
Stage III NSCLC whose disease has not progressed following
platinum-based chemoradiation therapy (CRT). The number of
reimbursements increased to 28 in the
year. Imfinzi has
also been approved for the treatment of ES-SCLC patients in 51
countries, with five reimbursements obtained.
Total Revenue, entirely comprising Product Sales, amounted to
$2,042m in the year and represented growth of 39%, predominantly
for the treatment of unresectable, Stage III NSCLC patients. The US
increased by 14% to $1,185m; in Japan, growth of 28% (26% at CER)
represented sales of $270m. Europe increased by 106% (104% at CER)
to $370m, reflecting a growing number of reimbursements, while
Emerging Markets increased to $158m (FY 2019: $30m), following
recent regulatory approvals and launches, including in
China.
Lynparza
Lynparza has received
regulatory approval in 78 countries for the treatment of ovarian
cancer; it has also been approved in 76 countries for the treatment
of metastatic breast cancer, and in 55 countries for the
treatment of pancreatic cancer. Lynparza has received regulatory approval in 49
countries for the 2nd-line treatment of certain prostate-cancer
patients.
Lynparza Total Revenue
amounted to $2,236m in the year and represented growth of 24%; this
included Collaboration Revenue of $460m.
Product Sales in the year amounted to $1,776m, reflecting growth of
48% (49% at CER). The strong performance was geographically spread,
with further indication launches continuing globally. US Product
Sales increased by 40% to $876m, as the launches in prostate cancer
and 1st-line HRD+ ovarian cancer started to take
effect. Lynparza continued to be the leading medicine in the
poly ADP ribose polymerase-inhibitor (PARPi) class, as measured by
total prescription volumes. Product Sales in Europe increased by
52% (51% at CER) to $435m, reflecting additional reimbursements and
increasing BRCAm-testing rates, as well as successful recent
1st-line BRCAm ovarian cancer launches, including in the UK and
Germany.
Japan Product Sales of Lynparza amounted to $167m, representing growth of
29% (27% at CER). Emerging Markets Product Sales were $264m, up by
98% (108% at CER). In China, Lynparza was admitted to the NRDL as a 1st-line
treatment for BRCAm ovarian cancer patients with effect from March
2021.
Enhertu
US sales, recorded by Daiichi Sankyo Company Limited (Daiichi
Sankyo), amounted to $200m in the year, including $64m in the
quarter. Enhertu was approved at the end of 2019 by
the US FDA for the treatment of 3rd-line HER2+ breast
cancer. Total Revenue, entirely comprising Collaboration Revenue
recorded by AstraZeneca, amounted to $96m in the year, with $33m
recorded in the quarter.
Calquence
Total Revenue, entirely comprising Product Sales, amounted to $522m
in the year and represented growth of 219%, with the overwhelming
majority of sales in the US. Calquence was approved by the US FDA for the treatment
of CLL in November 2019. In total, Calquence has received regulatory approvals for this
indication in 51 countries and in 23 countries for the treatment of
patients with R/R mantle cell lymphoma (MCL).
Koselugo
Total Revenue, entirely comprising Product Sales in the US,
amounted to $38m in the year, following its launch during the
second quarter for the treatment of the rare disease NF1 in
paediatric patients aged two years and older who have symptomatic,
inoperable plexiform neurofibromas.
Zoladex
Total Revenue, predominantly comprising Product Sales, amounted to
$938m in the year and represented growth of 13% (17% at
CER).
Emerging Markets Product Sales of Zoladex increased by 14% (20% at CER) to $561m,
reflecting increased use and access in prostate cancer. Product
Sales in Europe increased by 4% to $140m while, in the Established
Rest of World (RoW) region, Product Sales increased by 1% to
$182m.
Faslodex
Total Revenue, entirely comprising Product Sales, amounted to $580m
in the year and represented a decline of 35% (34% at
CER).
Emerging Markets fell by 9% (4% at CER) to $180m, while US sales
declined by 83% to $55m, reflecting the launch in 2019 of multiple
generic Faslodex medicines; in Europe, sales fell by 3% to
$221m. In Japan, they declined by 11% (13% at CER) to $116m, driven
by a mandated price reduction in the second
quarter.
Iressa
Total Revenue, entirely comprising Product Sales, amounted to $268m
in the year and represented a decline of 37% (36% at CER). Emerging
Markets fell by 23% (22% at CER) to $221m, driven by the impact
of Iressa's inclusion in China's VBP programme and
subsequent price reduction.
BioPharmaceuticals: CVRM
Total Revenue increased by 3% in the year (4% at CER) to $7,139m
and represented 27% of Total Revenue (FY 2019: 29%). This included
roxadustat Collaboration Revenue of $30m, as well as the Product
Sales of Crestor and other legacy
medicines.
New CVRM Total Revenue, which excludes sales
of Crestor and other legacy medicines, increased by 7%
in the year (9% at CER) to $4,702m, mainly reflecting the strong
performance of Farxiga. New CVRM represented 66% of overall CVRM Total
Revenue in the year (FY 2019: 63%).
Farxiga
Total Revenue, predominantly comprising Product Sales, amounted to
$1,964m in the year and represented growth of 27% (30% at CER). Q4
2020 Total Revenue increased by 40% to $587m, reflecting volume
growth across the regions.
Emerging Markets Product Sales increased by 46% in the year (55% at
CER) to $686m. In China, Forxiga was admitted to the NRDL with effect from
the start of 2020; as expected, this adversely impacted pricing.
This was, however, more than offset by the derived volume
uplift.
US Product Sales increased by 6% in the year to $569m, partly
driven by regulatory approval in May 2020 for the treatment of
patients with heart failure with reduced ejection fraction (HFrEF)
in both patients with and without T2D, based on the compelling
patient benefit seen in the results from the DAPA-HF trial. Sales
in the fourth quarter increased by 31% to $184m, reflecting by the
comparative effect of an adverse prior-year gross-to-net
adjustment.
Product Sales in Europe increased by 36% in the year (35% at CER)
to $507m, partly reflecting growth in the SGLT2[43] class,
the beneficial addition of CVOT data to the label and HFrEF
regulatory approval in November 2020. In Japan, sales to
collaborator Ono Pharmaceutical Co., Ltd, which records in-market
sales, increased by 29% (27% at CER) to $117m.
Brilinta
Total Revenue, entirely comprising Product Sales, amounted to
$1,593m in the year and represented growth of 1% (2% at
CER).
Global demand over the year was adversely impacted by the effects
of COVID-19, reflected in fewer acute coronary syndrome hospital
admissions. Sales in Q4 2020 declined by 15% to $363m, also driven
by a VBP-related mandatory price reduction in China in Q3
2020.
Emerging Markets sales were stable in the year (up by 4% at CER) at
$461m. Sales in the fourth quarter, however, declined by 39% (36%
at CER) to $69m, following the aforementioned price reduction in
China. US sales, at $732m, represented growth of 3%, with an
increase in the average-weighted duration of treatment partly
offset by the adverse COVID-19 impact, also reflected in fewer
elective procedures. Sales of Brilique in Europe declined by 3% in the year to
$342m, with the performance similarly impacted by
COVID-19.
Onglyza
Total Revenue, entirely comprising Product Sales, amounted to $470m
in the year and represented a decline of 11% (10% at
CER).
Sales in Emerging Markets increased by 14% (18% at CER) to $201m,
driven by the performance in China and the growing
DPP-4[44] class.
US sales of Onglyza fell by 28% in the year to $166m, while
Europe sales declined by 16% (17% at CER) to $58m, highlighting the
shift away from the class.
Bydureon
Total Revenue, entirely comprising Product Sales, amounted to $448m
in the year and represented a decline of 18%.
US sales of $382m reflected a fall of 17% in the year, resulting
from competitive pressures and the impact of managed markets. Sales
in Europe declined by 20% to $53m.
Lokelma
Total Revenue, entirely comprising Product Sales, amounted to $76m
in the year (FY 2019: $14m), an increase of 461% (463% at CER),
despite the impact from COVID-19 on the overall market. The US
represented the overwhelming majority of
sales; Lokelma continued to lead new-to-brand prescription
market share in the US. The medicine has received regulatory
approval in several markets for the treatment of hyperkalaemia,
including in the EU, China and Japan, with further launches
anticipated in a number of markets soon. In December 2020, the
medicine was excluded from the latest round of the China NRDL
process.
Roxadustat
Total Revenue, entirely comprising Collaboration Revenue, amounted
to $30m in the year in China. Q4 2020 revenue of $11m reflected a
sequential quarterly increase of 46%. The Company continued to
focus in the year on achieving hospital listings and patient access
across China.
In July 2020, FibroGen Inc. (FibroGen) and AstraZeneca entered into
an amendment to revise the existing licence agreement for
roxadustat in China. From January 2021, the Company recognised the
overwhelming majority of its future revenue in China as Product
Sales.
Crestor
Total Revenue, predominantly comprising Product Sales, amounted to
$1,182m in the year and represented a decline of 10% (9% at
CER).
Product Sales in Emerging Markets fell by 7% (5% at CER) to $748m.
The performance continued to be adversely impacted by the ongoing
effects of the aforementioned VBP programme in China. US Product
Sales declined by 11% to $92m. In Europe, Total Revenue fell by 31%
(32% at CER) to $131m while, in Japan, where AstraZeneca
collaborates with Shionogi Co., Ltd, Product Sales declined by 4%
(5% at CER) to $164m.
In December 2020, it was announced that
the Company had agreed to sell the commercial rights
to Crestor in over 30 countries in Europe to
Grünenthal GmbH. The divestment closed earlier in the first
quarter of 2021.
BioPharmaceuticals: Respiratory & Immunology
Total Revenue declined by 1% in the year (stable at CER) to $5,375m
and represented 20% of Total Revenue (FY 2019: 22%). This included
Ongoing Collaboration Revenue of $18m from Duaklir, Eklira and other medicines.
Symbicort
Total Revenue, entirely comprising Product Sales, amounted to
$2,721m in the year and represented an increase of 9% (10% at CER),
a result of growth in the US. Q4 2020 Total Revenue declined by 5%
to $680m, driven by the impact of generic competition in
Europe and Japan. Symbicort remains the global market-volume and value
leader within the inhaled corticosteroid (ICS) / long-acting beta
agonist (LABA) class.
US sales grew by 23% in the year to $1,022m; an authorised-generic
version of Symbicort was launched in the US by the Company's
collaborator, Prasco LLC (Prasco), in January 2020. The performance
in Emerging Markets in the year slowed down versus FY 2019,
reflecting a reduction in hospital visits in China due to COVID-19,
leading to fewer initiations. Despite this, Emerging Markets sales
increased by 4% (9% at CER) to $567m.
In Europe, sales increased by 2% in the year to $694m, with
positive volume growth seen in the major countries. In Japan, sales
declined by 16% (18% at CER) to $189m, driven by the impact of
generic competition and an unfavourable price comparison versus
2019, partly reflecting the termination of the Astellas Pharma Inc.
co-promotion agreement. This impact in Japan was particularly acute
in the fourth quarter, when sales declined by 53% (54% at CER) to
$45m.
Pulmicort
Total Revenue, entirely comprising Product Sales, amounted to $996m
in the year and represented a decline of 32%, as
the continued effects of COVID-19 impacted the hospital
treatment of respiratory patients. Q4 2020 Total Revenue
declined by 11% (14% at CER) to $368m.
Emerging Markets, where Pulmicort sales fell by 33% in the year to $798m,
represented 80% of the global total. Alongside the effects of
COVID-19, the performance in China was impacted by a reduction in
the number of paediatric patients attending outpatient nebulisation
rooms. In the fourth quarter, however, the volume of adult elective
procedures, a smaller use, largely
recovered. Pulmicort can be used in this setting when oral
corticosteroids (OCS) are unsuitable.
Sales in the US declined by 35% in the year to $71m, due to the
fall in the use of Pulmicort Respules. In Japan, sales declined by 51% (52% at CER) to
$30m as a result of generic competition and fell in Europe by 10%
to $73m.
Fasenra
Fasenra has received
regulatory approval in 59 countries, including the US, in the EU
and Japan for the treatment of patients with severe, uncontrolled
eosinophilic asthma. With further regulatory reviews
ongoing, Fasenra has already achieved reimbursement in 47
countries.
Total Revenue, entirely comprising Product Sales, amounted to $949m
in the year and represented growth of 35% (34% at CER), a result of
increased demand, despite the impact of COVID-19 on the level
of new-patient starts in several
countries. Fasenra remained
the leading novel biologic in the majority of markets in the
new-to-brand prescription share for patients with severe,
uncontrolled asthma.
Sales in the US grew by 25% in the year to $603m, due to
increased volume demand as a result of the impact of COVID-19
earlier in the year. The adverse effect of COVID-19 on the dynamic
market was partially offset by the growth in market share and
increased persistency. In Europe, sales of $203m represented
an increase of 72% (70% at CER), reflecting ongoing successful
launches and additional reimbursement. Sales in Japan increased by
16% (14% at CER) to $100m. In Emerging Markets, sales amounted to
$12m (FY 2019: $5m).
Daliresp/Daxas
Total Revenue, entirely comprising Product Sales, amounted to $217m
in the year and represented an increase of 1%. US sales, comprising
88% of the global total, increased by 3% to $190m.
Bevespi
Total Revenue, entirely comprising Product Sales, amounted to $48m
in the year and represented an increase of 16% (15% at
CER). Bevespi has been launched in the US, in a number of
European countries and in Japan. Sales in the US increased by 7% in
the year to $44m while, in Europe, sales amounted to $3m (FY 2019:
$nil). Bevespi was recently included in the China NRDL,
with effect from March 2021.
Breztri
Breztri has received
regulatory approval in 34 countries, including the US, in the EU,
China and Japan for the treatment of patients with COPD. With
further regulatory reviews ongoing, Breztri has already achieved reimbursement in four
countries.
Total Revenue, entirely comprising Product Sales, amounted to $28m
in the year (FY 2019: $2m). Sales in the US amounted to $5m (FY
2019: $nil), largely as a result of stocking. Sales in Japan
amounted to $9m (FY 2019: $2m) where prescriptions were limited by
Ryotanki, a regulation which limits prescriptions to two weeks'
supply in the first year of launch. In October 2020, Ryotanki was
lifted for Breztri and the restriction no longer applied.
Emerging Markets amounted to $14m (FY 2019:
$nil). Breztri was recently included in the China NRDL,
with effect from March 2021.
Other medicines (outside the three main therapy areas)
Total Revenue, primarily comprising Product Sales, amounted to
$2,649m in the year, representing a decline of 2%. The performance
partly reflected the divestment of
global rights to Movantik, excluding Europe, Canada and Israel, to RedHill
Biopharma in April 2020. Other medicines Total Revenue represented
10% of overall Total Revenue (FY 2019: 11%).
Nexium
Total Revenue, predominantly comprising Product Sales, amounted to
$1,524m in the year, representing an increase of 1% (2% at CER).
Emerging Markets Product Sales of Nexium increased by 1% (4% at CER) to $757m in the
year, with particular strength in Q4 2020 when sales of $193m
represented an increase of 11%, reflecting later phasing of demand
in the year.
In Japan, where AstraZeneca collaborates with Daiichi Sankyo,
Product Sales increased by 6% (4% at CER) to $423m, while Product
Sales in the US declined by 22% to $169m. In Europe, Product Sales
increased by 12% (10% at CER) to $71m.
Further to the previous VBP-programme round in Q4 2020, China
concluded another round in February 2021,
including Nexium (oral). The Company, however, chose not to
compete on price and consequently accepted a mandatory price
reduction of 30%.
Losec/Prilosec
Total Revenue, entirely comprising Product Sales, amounted to $183m
in the year, representing a decline of 30%. This partly reflected
the divestment of
global commercial rights, excluding China, Japan, the US and
Mexico, to Cheplapharm Arzneimittel GmbH (Cheplapharm) in October
2019. Emerging Markets fell by 15% (14% at CER) to $152m
as Losec was subject to a mandatory price reduction
as part of the impact of aforementioned VBP programme in China;
sales in Europe fell by 59% to $20m.
FluMist
Total Revenue, entirely comprising Product Sales, increased by 161%
in the year (153% at CER) to $295m, reflecting the greater use of
influenza vaccines as health authorities in northern-hemisphere
countries expanded seasonal-vaccination programmes beyond typical
levels during the ongoing COVID-19 pandemic. In the US, sales
increased by 254% in the year to $70m and, in Europe, by 135% (126%
at CER) to $219m.
Synagis
The commercial rights to the sale and distribution
of Synagis outside the US, held by AbbVie Inc (AbbVie)
since 1997, will revert to AstraZeneca upon the expiry of the
current agreement on 30 June 2021. In general, the Company will
solely distribute and promote the medicine outside the US from 1
July 2021. The agreement with Swedish Orphan Biovitrum AB (publ),
for the rights to Synagis in the US, was unaffected by this
decision.
Total Revenue, entirely comprising Product Sales, amounted to $372m
in the year, representing an increase of 4%. In Q4 2020, global
sales increased by 24% to $78m, reflecting the phasing of orders
from AbbVie and preparations for the aforementioned reversion of
commercial rights. Sales in Europe, wholly reflecting sales to
AbbVie made under the current supply agreement for markets outside
the US, amounted to $325m in the year, representing an increase of
4%.
Regional Total Revenue
Table 12: Regional Total
Revenue
|
FY 2020
|
Q4 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Emerging
Markets
|
8,711
|
33
|
7
|
10
|
2,244
|
7
|
8
|
- China
|
5,375
|
20
|
10
|
11
|
1,362
|
15
|
9
|
- Ex-China
|
3,336
|
13
|
1
|
9
|
882
|
(2)
|
7
|
|
|
|
|
|
|
|
|
US
|
8,833
|
33
|
13
|
13
|
2,388
|
15
|
15
|
|
|
|
|
|
|
|
|
Europe
|
5,540
|
21
|
10
|
9
|
1,831
|
17
|
12
|
|
|
|
|
|
|
|
|
Established
RoW
|
3,533
|
13
|
6
|
5
|
947
|
2
|
(1)
|
- Japan
|
2,620
|
10
|
1
|
-
|
718
|
(2)
|
(5)
|
- Canada
|
605
|
2
|
29
|
31
|
146
|
16
|
16
|
- Other
Est. RoW
|
308
|
1
|
8
|
10
|
83
|
11
|
7
|
|
|
|
|
|
|
|
|
Total
|
26,617
|
100
|
9
|
10
|
7,410
|
11
|
10
|
A geographical split of Product Sales is shown in Note 7. For
additional details, refer to Table 49: Historic
Collaboration Revenue for
Collaboration Revenue recognised during FY 2020 and FY
2019.
Table 13: Emerging Markets
therapy-area performance - Total Revenue
|
FY 2020
|
Q4 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
2,906
|
33
|
31
|
36
|
668
|
22
|
24
|
BioPharmaceuticals
|
3,007
|
35
|
(4)
|
-
|
882
|
2
|
2
|
- New CVRM
|
1,407
|
16
|
24
|
31
|
335
|
12
|
17
|
- Respiratory &
Immunology
|
1,600
|
18
|
(19)
|
(18)
|
547
|
(4)
|
(5)
|
Other medicines
|
2,798
|
32
|
(1)
|
2
|
694
|
2
|
3
|
|
|
|
|
|
|
|
|
Total
|
8,711
|
100
|
7
|
10
|
2,244
|
7
|
8
|
Emerging Markets Total Revenue grew by 7% (10% at CER) to $8,711m
in the year and, in the fourth quarter, by 7% (8% at CER) to
$2,244m. The new medicines represented 33% of Emerging Markets
Total Revenue in the year (FY 2019: 23%). Speciality-care medicines
increased by 27% (32% at CER) to $3,414m and comprised 39% of
Emerging Markets Total Revenue in the year (FY 2019:
33%).
Table 14: Notable new-medicine
performances in Emerging Markets - Total
Revenue
|
FY 2020
|
Q4 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Tagrisso
|
1,208
|
14
|
59
|
63
|
258
|
23
|
23
|
Forxiga
|
686
|
8
|
46
|
55
|
198
|
50
|
57
|
Brilinta
|
461
|
5
|
-
|
4
|
69
|
(40)
|
(37)
|
Lynparza[45]
|
264
|
3
|
98
|
n/m
|
69
|
n/m
|
n/m
|
China comprised 62% of Emerging Markets Total Revenue in the year
and increased by 10% (11% at CER) to $5,375m. New medicines,
primarily driven by Tagrisso and Lynparza in Oncology and Forxiga in New CVRM, delivered particularly
encouraging growth and represented 31% of China Total Revenue (FY
2019: 19%); strong sales of Zoladex, Seloken and Symbicort supplemented this performance. The
aforementioned decline of Pulmicort in China, however, restricted overall Total
Revenue growth in the year.
In Q4 2020, China growth of 15% (9% at CER) to $1,362m reflected
the impact of a mandatory 30% price reduction
for Brilinta, Losec and Arimidex, which were unsuccessful in the latest round of
VBP, following the Company's decision not to compete with generic
competitor price in the tender process.
Table 15: Ex-China Emerging Markets:
Total Revenue
|
FY 2020
|
Q4 2020
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Ex-China Asia Pacific
|
1,237
|
5
|
6
|
341
|
7
|
5
|
Middle East and Africa
|
1,024
|
(3)
|
1
|
256
|
(12)
|
(5)
|
Ex-Brazil Latin America
|
447
|
-
|
18
|
130
|
2
|
21
|
Russia
|
314
|
28
|
42
|
77
|
11
|
33
|
Brazil
|
314
|
(15)
|
10
|
78
|
(17)
|
11
|
|
|
|
|
|
|
|
Total
|
3,336
|
1
|
9
|
882
|
(2)
|
7
|
Ex-China Emerging Markets Total Revenue, primarily comprising
Product Sales, increased by 1% in the year (9% at CER) to $3,336m.
The new medicines represented 36% of ex-China Emerging Markets
Total Revenue (FY 2019: 29%), increasing by 25% (35% at CER) to
$1,194m.
Notable performances in ex-China Emerging Markets included growth
in Russia of 28% (42% at CER) to $314m and a stable performance in
ex-Brazil Latin America (growth of 18% at CER), representing Total
Revenue of $447m.
Financial performance
Table 16: Reported Profit and Loss -
FY 2020
|
FY 2020
|
FY 2019
|
% change
|
$m
|
$m
|
Actual
|
CER
|
Total Revenue
|
26,617
|
24,384
|
9
|
10
|
- Product
Sales
|
25,890
|
23,565
|
10
|
11
|
- Collaboration
Revenue
|
727
|
819
|
(11)
|
(11)
|
|
|
|
|
|
Cost of Sales
|
(5,299)
|
(4,921)
|
8
|
8
|
|
|
|
|
|
Gross Profit
|
21,318
|
19,463
|
10
|
11
|
Gross Profit Margin
|
79.5%
|
79.1%
|
-
|
+1
|
|
|
|
|
|
Distribution Expense
|
(399)
|
(339)
|
18
|
19
|
% Total Revenue
|
1.5%
|
1.4%
|
-
|
-
|
R&D Expense
|
(5,991)
|
(6,059)
|
(1)
|
(1)
|
% Total Revenue
|
22.5%
|
24.8%
|
+2
|
+3
|
SG&A Expense
|
(11,294)
|
(11,682)
|
(3)
|
(3)
|
% Total Revenue
|
42.4%
|
47.9%
|
+5
|
+6
|
|
|
|
|
|
Other Operating Income & Expense
|
1,528
|
1,541
|
(1)
|
(1)
|
% Total Revenue
|
5.7%
|
6.3%
|
-1
|
-1
|
|
|
|
|
|
Operating Profit
|
5,162
|
2,924
|
77
|
81
|
Operating Profit Margin
|
19.4%
|
12.0%
|
+7
|
+8
|
|
|
|
|
|
Net Finance Expense
|
(1,219)
|
(1,260)
|
(3)
|
(4)
|
Joint Ventures and Associates
|
(27)
|
(116)
|
(77)
|
(76)
|
|
|
|
|
|
Profit Before Tax
|
3,916
|
1,548
|
n/m
|
n/m
|
|
|
|
|
|
Taxation
|
(772)
|
(321)
|
n/m
|
n/m
|
Tax Rate
|
20%
|
21%
|
|
|
|
|
|
|
|
Profit After Tax
|
3,144
|
1,227
|
n/m
|
n/m
|
|
|
|
|
|
EPS
|
$2.44
|
$1.03
|
n/m
|
n/m
|
Table 17: Reported Profit and Loss - Q4 2020
|
Q4 2020
|
Q4 2019
|
% change
|
$m
|
$m
|
Actual
|
CER
|
Total Revenue
|
7,410
|
6,664
|
11
|
10
|
- Product
Sales
|
7,011
|
6,250
|
12
|
11
|
- Collaboration
Revenue
|
399
|
414
|
(4)
|
(4)
|
|
|
|
|
|
Cost of Sales
|
(1,525)
|
(1,378)
|
11
|
5
|
|
|
|
|
|
Gross Profit
|
5,885
|
5,286
|
11
|
11
|
Gross Profit Margin
|
78.2%
|
78.0%
|
-
|
+1
|
|
|
|
|
|
Distribution Expense
|
(109)
|
(92)
|
18
|
16
|
% Total Revenue
|
1.5%
|
1.4%
|
-
|
-
|
R&D Expense
|
(1,719)
|
(2,091)
|
(18)
|
(19)
|
% Total Revenue
|
23.2%
|
31.4%
|
+8
|
+8
|
SG&A Expense
|
(3,210)
|
(3,026)
|
6
|
4
|
% Total Revenue
|
43.3%
|
45.4%
|
+2
|
+2
|
|
|
|
|
|
Other Operating Income & Expense
|
640
|
500
|
28
|
29
|
% Total Revenue
|
8.6%
|
7.5%
|
+1
|
+1
|
|
|
|
|
|
Operating Profit
|
1,487
|
577
|
n/m
|
n/m
|
Operating Profit Margin
|
20.1%
|
8.7%
|
+11
|
+13
|
|
|
|
|
|
Net Finance Expense
|
(314)
|
(312)
|
1
|
-
|
Joint Ventures and Associates
|
(6)
|
(25)
|
(79)
|
(79)
|
|
|
|
|
|
Profit Before Tax
|
1,167
|
240
|
n/m
|
n/m
|
|
|
|
|
|
Taxation
|
(162)
|
37
|
n/m
|
n/m
|
Tax Rate
|
14%
|
(15)%
|
|
|
|
|
|
|
|
Profit After Tax
|
1,005
|
277
|
n/m
|
n/m
|
|
|
|
|
|
EPS
|
$0.78
|
$0.24
|
n/m
|
n/m
|
Table 18: Reconciliation of Reported
Profit Before Tax to EBITDA - FY 2020
|
FY 2020
|
FY 2019
|
% change
|
$m
|
$m
|
Actual
|
CER
|
Reported Profit Before Tax
|
3,916
|
1,548
|
n/m
|
n/m
|
|
|
|
|
|
Net Finance Expense
|
1,219
|
1,260
|
(3)
|
(4)
|
Joint Ventures and Associates
|
27
|
116
|
(77)
|
(76)
|
Depreciation, Amortisation and Impairment
|
3,149
|
3,762
|
(16)
|
(16)
|
|
|
|
|
|
EBITDA
|
8,311
|
6,686
|
24
|
27
|
Table 19: Reconciliation of Reported Profit Before Tax to EBITDA -
Q4 2020
|
Q4 2020
|
Q4 2019
|
% change
|
$m
|
$m
|
Actual
|
CER
|
Reported Profit Before Tax
|
1,167
|
240
|
n/m
|
n/m
|
|
|
|
|
|
Net Finance Expense
|
314
|
312
|
1
|
-
|
Joint Ventures and Associates
|
6
|
25
|
(79)
|
(79)
|
Depreciation, Amortisation and Impairment
|
797
|
1,643
|
(52)
|
(53)
|
|
|
|
|
|
EBITDA
|
2,284
|
2,220
|
3
|
6
|
Table 20: Reconciliation of Reported
to Core financial measures - FY 2020
FY 2020
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Diabetes Alliance
|
Other
|
Core[46]
|
Core
% change
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross Profit
|
21,318
|
53
|
66
|
-
|
5
|
21,442
|
9
|
10
|
Gross Profit Margin
|
79.5%
|
|
|
|
|
80.0%
|
-
|
-
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(399)
|
-
|
-
|
-
|
-
|
(399)
|
18
|
19
|
R&D Expense
|
(5,991)
|
35
|
84
|
-
|
-
|
(5,872)
|
10
|
10
|
SG&A Expense
|
(11,294)
|
162
|
1,657
|
310
|
(197)
|
(9,362)
|
3
|
4
|
Total Operating Expense
|
(17,684)
|
197
|
1,741
|
310
|
(197)
|
(15,633)
|
6
|
6
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
1,528
|
1
|
2
|
-
|
-
|
1,531
|
(2)
|
(2)
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
5,162
|
251
|
1,809
|
310
|
(192)
|
7,340
|
14
|
17
|
Operating Profit Margin
|
19.4%
|
|
|
|
|
27.6%
|
+1
|
+2
|
|
|
|
|
|
|
|
|
|
Net Finance Expense
|
(1,219)
|
-
|
-
|
228
|
209
|
(782)
|
2
|
2
|
Taxation
|
(772)
|
(50)
|
(376)
|
(127)
|
13
|
(1,312)
|
18
|
21
|
|
|
|
|
|
|
|
|
|
EPS
|
$2.44
|
$0.15
|
$1.10
|
$0.31
|
$0.02
|
$4.02
|
15
|
18
|
Table 21: Reconciliation of Reported to Core financial measures -
Q4 2020
Q4 2020
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Diabetes Alliance
|
Other
|
Core46
|
Core
% change
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross Profit
|
5,885
|
9
|
16
|
-
|
1
|
5,911
|
12
|
12
|
Gross Profit Margin
|
78.2%
|
|
|
|
|
78.6%
|
+1
|
+2
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(109)
|
-
|
-
|
-
|
-
|
(109)
|
18
|
16
|
R&D Expense
|
(1,719)
|
5
|
7
|
-
|
-
|
(1,707)
|
14
|
12
|
SG&A Expense
|
(3,210)
|
95
|
429
|
64
|
(216)
|
(2,838)
|
8
|
6
|
Total Operating Expense
|
(5,038)
|
100
|
436
|
64
|
(216)
|
(4,654)
|
11
|
8
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
640
|
2
|
-
|
-
|
-
|
642
|
28
|
29
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
1,487
|
111
|
452
|
64
|
(215)
|
1,899
|
23
|
28
|
Operating Profit Margin
|
20.1%
|
|
|
|
|
25.6%
|
+2
|
+4
|
|
|
|
|
|
|
|
|
|
Net Finance Expense
|
(314)
|
-
|
-
|
54
|
55
|
(205)
|
10
|
15
|
Taxation
|
(162)
|
(22)
|
(92)
|
(35)
|
14
|
(297)
|
52
|
59
|
|
|
|
|
|
|
|
|
|
EPS
|
$0.78
|
$0.06
|
$0.28
|
$0.06
|
($0.11)
|
$1.07
|
19
|
24
|
Profit and Loss summary
a) Gross Profit
The increases in Reported and Core Gross Profit in the year
reflected the growth in Product Sales. The Reported Gross Profit
Margin was stable (up by one percentage point at CER) at 80%, while
the Core Gross Profit Margin was stable at 80%, with a favourable
mix of sales offset by increasing pricing pressure in China related
to the impacts of the NRDL and the VBP programme. The performance
was in line with the Company's expectations.
b) Total Operating Expense
Reported Total Operating Expense declined by 2% in the year to
$17,684m and represented 66% of Total Revenue (FY 2019: 74%). Core
Total Operating Expense increased by 6% to $15,633m and comprised
59% of Total Revenue (FY 2019: 60%).
-
The increase in Reported and Core Distribution Expense in the year
was a result of adverse logistics impacts from the COVID-19
pandemic
- The decline in Reported
R&D Expense was partly driven by the comparative effect of the
$533m impairment of Epanova in FY 2019. The growth in Core R&D
Expense included investment in the Oncology pipeline, such as the
development of datopotamab deruxtecan and the ending in FY 2019 of
the release of the upfront funding of Lynparza development, as part of the
aforementioned collaboration with
MSD. There were also additional costs related to COVID-19, such as
the expense of personal protective equipment and colleague
testing
- AstraZeneca also
mobilised research efforts to treat patients with severe COVID-19
symptoms; these efforts included the development of AZD7442, the
LAAB that may have a role in the prevention and/or treatment of
COVID-19. In line with IAS 20 'Accounting for Government Grants and
Disclosure of Government Assistance', government grants related to
the development of C19VAZ and AZD7442 were recognised in the
Consolidated statement of comprehensive income so as to match with
the related expenses that they were intended to compensate. Where
grants are received in advance of the related expenses, they are
initially recognised in the Consolidated statement of financial
position and released to match the related
expenditure
-
The difference in the movements of Reported and Core SG&A
Expense partly reflected fair-value adjustments arising on
acquisition-related liabilities, as well as an increase in legal
provisions recognised in 2019. Within Reported and Core SG&A
Expense, pandemic-related savings partly compensated for investment
in the launches of new medicines and expansion in
China
c) Other
Operating Income and Expense[47]
Reported Other Operating Income and Expense in the year of $1,528m
reflected a decline of 1%. Core Other Operating Income and Expense
in the year, decreasing by 2% to $1,531m, included:
- $400m of income
from the aforementioned agreement to divest of commercial
rights to Atacand and Atacand Plus in
over 70 countries to Cheplapharm
- $350m of income from
an agreement to
divest commercial rights to a number of legacy hypertension
medicines to Atnahs Pharma
-
Income from the monetisation of an asset previously
licensed
-
Payments from Allergan (part of AbbVie) of $107m in respect of the
development of brazikumab
d) Net Finance Expense
The increase in Core Net Finance Expense partly reflected lower
interest rates on cash, cash equivalents and other current
investments.
e) Taxation
The Reported and Core Tax Rates for the year were both 20% (FY
2019: 21% and 20%, respectively). The net cash tax paid in the year
was $1,562m, representing 40% of Reported Profit Before Tax (FY
2019: $1,118m, 72%); the increase partly reflected the growth in
Reported Profit Before Tax and the phasing of tax
payments.
f) Non-controlling
interests
Reported total comprehensive losses attributable to non-controlling
interests amounted to $52m in the year
(FY 2019: $108m), of which $55m related to the non-controlling
interest in Acerta Pharma.
In FY 2016, AstraZeneca acquired a 55% controlling stake in Acerta
Pharma, where the non-controlling interests were subject to put and
call options; the put option gave rise to a liability at 31
December 2020 of $2,297m (31 December 2019: $2,146m), shown in
non-current other payables. The ability of the parties to exercise
their respective put and call options, as well as the timing and
amount of exercise, was dependent on certain conditions, the last
of which was based on the regulatory approval
of Calquence in the EU.
In November 2020, Calquence received marketing approval in the EU, which
removed all remaining conditionality in respect of the options. The
minority shareholders were then considered to have no further
substantive variability in risk and reward related to their shares,
as it was considered highly likely that one of the options will be
exercised, and the price of the options were then fixed. Therefore,
from November 2020, no further amounts of the consolidated
AstraZeneca result were attributed to the minority shareholders of
Acerta Pharma and no further impact on non-controlling interests in
relation to Acerta Pharma is anticipated. In addition, the
non-controlling interests reserve relating to the minority
shareholders of Acerta Pharma, totalling $1,401m, has been
reclassified into Retained earnings (see Condensed Consolidated
Statement of Changes in Equity).
g) Dividend per share
The Board reaffirms its commitment to the progressive dividend
policy. A stable second interim dividend of $1.90 per share (137.4
pence, 15.76 SEK) has been declared, meaning a stable full-year
dividend per share of $2.80 (207.0 pence, 23.63 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 2020, payable
on 29 March 2021, will be 26 February 2021. The ex-dividend date
will be 25 February 2021. The record date for the first interim
dividend for 2021, payable on 13 September 2021, will be 13 August
2021. The ex-dividend date will be 12 August 2021.
h) EPS
Reported EPS of $2.44 in the year represented an increase of 137%
(142% at CER); Core EPS increased by 15% (18% at CER) to
$4.02.
Table 22: Cash
Flow
|
FY 2020
|
FY 2019
|
Change
|
$m
|
$m
|
$m
|
Reported Operating Profit
|
5,162
|
2,924
|
2,238
|
Depreciation, Amortisation and Impairment
|
3,149
|
3,762
|
(613)
|
|
|
|
|
Decrease/(increase) in Working Capital and Short-Term
Provisions
|
361
|
(346)
|
707
|
Gains on Disposal of Intangible Assets
|
(1,030)
|
(1,243)
|
213
|
Non-Cash and Other Movements
|
(548)
|
(236)
|
(312)
|
Interest Paid
|
(733)
|
(774)
|
41
|
Taxation Paid
|
(1,562)
|
(1,118)
|
(444)
|
|
|
|
|
Net Cash Inflow from Operating Activities
|
4,799
|
2,969
|
1,830
|
|
|
|
|
Net Cash Inflow before Financing Activities
|
4,514
|
2,312
|
2,202
|
|
|
|
|
Net Cash Outflow from Financing Activities
|
(2,203)
|
(1,765)
|
(438)
|
The increase in Net Cash Inflow from Operating Activities in the
year reflected an improvement in Reported Operating Profit
while C19VAZ contributions increased Net Cash Inflow from
Operating Activities by $1,062m in the year; the movement was
primarily related to changes in C19VAZ working-capital balances within trade and
other payables, trade and other receivables and inventories. The
reduction in Interest Paid was partly a result of a decline on
interest paid on bonds, while the increase in Taxation Paid was a
reflection of the growth in Reported Profit Before Tax and the
phasing of tax payments.
The increase in Net Cash Inflow before Financing Activities was a
result of the aforementioned improvement in Net Cash Inflow from
Operating Activities, as well as a $1,363m increase in the Disposal
of Non-Current Asset Investments to $1,381m. AstraZeneca sold part
of its equity portfolio in the year, a large proportion of which
related to the disposal of its full holding in Moderna
Therapeutics, Inc. All related gains were accounted through Other
Comprehensive Income.
Recorded within the Purchase of Intangible Assets, AstraZeneca made
the second of two $675m upfront payments to Daiichi Sankyo, as part
of the 2019 agreement on Enhertu.
The first of three non-contingent payments were also made to
Daiichi Sankyo in respect of the potential new Oncology medicine,
datopotamab deruxtecan; the payment amounted to
$350m.
Under the terms of a past agreement to acquire Pearl Therapeutics
Inc., the Company made a $150m milestone payment in the year upon
the US regulatory approval of Breztri for the treatment of COPD. This was the
final development and regulatory milestone under that agreement.
The cash payment of contingent consideration, in respect of the
former BMS share of the global diabetes alliance, amounted to $546m
in the year.
Capital Expenditure
Capital Expenditure amounted to $961m in the year, compared to
$979m in FY 2019. This included investment in the new AstraZeneca
R&D centre on the Biomedical Campus in Cambridge, UK, to which
a number of colleagues are expected to begin relocation this
year.
The Company anticipates an increase in Capital Expenditure, partly
driven by an expansion in its capacity for growth across a number
of limited-sized projects.
Table 23: Net Debt
summary
|
At 31 Dec 2020
|
At 31 Dec 2019
|
$m
|
$m
|
Cash
and cash equivalents
|
7,832
|
5,369
|
Other
investments
|
160
|
911
|
|
|
|
Cash and investments
|
7,992
|
6,280
|
|
|
|
Overdrafts
and short-term borrowings
|
(658)
|
(225)
|
Lease
liabilities
|
(681)
|
(675)
|
Current
instalments of loans
|
(1,536)
|
(1,597)
|
Non-current
instalments of loans
|
(17,505)
|
(15,730)
|
|
|
|
Interest-bearing loans and borrowings
(Gross Debt)
|
(20,380)
|
(18,227)
|
|
|
|
Net
derivatives
|
278
|
43
|
Net Debt
|
(12,110)
|
(11,904)
|
Net Debt of $12,110m represented an increase of $206m in the year.
EBITDA increased by 24% in the year (27% at CER) to
$8,311m.
Details of the committed undrawn bank facilities are disclosed
within the going-concern section of Note 1.
In the year, there were no changes to the Company's credit ratings
issued by Standard and Poor's (long term: BBB+, short term A-2) and
Moody's (long term: A3, short term P-2).
Capital allocation
The Board's aim is to continue to strike a balance between the
interests of the business, financial creditors and the Company's
shareholders. After providing for investment in the business,
supporting the progressive dividend policy and maintaining a
strong, investment-grade credit rating, the Board will keep under
review potential investment in immediately earnings-accretive,
value-enhancing opportunities.
Foreign exchange
The Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies' reporting currency. Foreign-exchange
gains and losses on forward contracts for transactional hedging are
taken to profit or loss. In addition, the Company's external
dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment
date.
Table 24: Currency
sensitivities
The Company provides the following currency-sensitivity
information:
|
Average Exchange
Rates versus USD
|
|
Annual Impact of 5% Strengthening in Exchange Rate versus USD
($m)[48]
|
Currency
|
Primary Relevance
|
FY 2020[49]
|
YTD 2021[50]
|
% change
|
Product Sales
|
Core Operating Profit
|
CNY
|
Product
Sales
|
6.90
|
6.47
|
6
|
312
|
186
|
EUR
|
Product
Sales
|
0.88
|
0.82
|
6
|
189
|
58
|
JPY
|
Product
Sales
|
106.74
|
103.70
|
3
|
140
|
91
|
Other[51]
|
|
|
|
|
239
|
108
|
|
|
|
|
|
|
|
GBP
|
Operating
Expense
|
0.78
|
0.73
|
6
|
31
|
(84)
|
SEK
|
Operating
Expense
|
9.20
|
8.29
|
10
|
5
|
(59)
|
Sustainability
AstraZeneca's sustainability approach has three priority
areas[52],
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:
During the period, the Company received recognition of its broad
sustainability efforts, featuring in the top five for the sector in
the DJSI and
included in Corporate Knights
Global 100 Index,
which identifies globally sustainable
companies.
a) Access to healthcare
In December 2020, AstraZeneca, through an advanced purchase
agreement with Gavi, the Vaccines Alliance, committed to enabling
access to 170m doses of C19VAZ in up to 190 countries worldwide through
COVAX, a coalition co-led by CEPI, the Coalition for Epidemic
Preparedness Innovations, Gavi, and the WHO. It is the only global
initiative working with governments and manufacturers to ensure
that safe and effective COVID-19 vaccines are available worldwide
to both higher-income and lower-income countries. Furthermore,
through additional doses announced by licensing partner Serum
Institute of India Pvt. Ltd., hundreds of millions of doses
of C19VAZ are anticipated to be available via COVAX.
At a press conference held to announce the news, Pascal Soriot
spoke on the importance of broad, equitable access alongside global
leaders, including WHO Director Dr Tedros Adhanom Ghebreyesus,
Canadian Minister for International Development, the Rt. Hon.
Karina Gould, and UNICEF Executive Director Henrietta Fore, as well
as COVAX and industry leadership.
AstraZeneca is committed to working with its global manufacturing
network to build global vaccine capacity to around three billion
doses, pending regulatory approvals. C19VAZ can be stored, transported and handled at
normal refrigerated conditions (two to eight degrees Celsius, 36-46
degrees Fahrenheit) for at least six months and administered within
existing healthcare settings.
In November 2020, the Company launched The Partnership for
Health System Sustainability and Resilience with the World Economic Forum (WEF) and the
London School of Economics (LSE) to identify practical solutions
that will support more resilient and sustainable health systems.
Part of the WEF's Great Reset
initiative, the partnership
will bring together a coalition of leading healthcare-system
experts in eight countries initially to test, perfect and apply a
Framework for Healthcare System Resilience and Sustainability,
developed by the LSE. The pilot countries are Germany, France, the
UK, Italy, Spain, Vietnam, Russia and Poland. Speaking about the
programme at the WEF Davos Agenda
event in January 2020,
Pascal Soriot emphasised the importance of building
crisis-resistant healthcare systems to recover from the pandemic
and protect against future shocks.
In January 2021, AstraZeneca was recognised in
the 2021 Access to
Medicines Index, rising two
places to rank seventh among peers. The accompanying report
highlighted the Company's continued progress, including strengths
in access-related governance, compliance and healthcare-system
development.
During the period, the AstraZeneca Young
Health Programme launched in the UK, focused on young people's mental health. The
programme will operate in four locations over the next five years
and uses youth-centred design, working together with young people,
to focus on tackling their urgent mental-health needs and realise
their right to good health and wellbeing. Over the five years, the
programme will work with over 130,000 young people aged between
10-24 and will initially launch in Manchester,
UK.
b) Environmental protection
During the period, AstraZeneca was recognised for
its leadership in
sustainability by global
environmental non-profit CDP. The Company received a place on the
'A List' for both climate action and water security. AstraZeneca
was one of only three organisations worldwide to achieve this
double A-List recognition for five consecutive years. The Company
also featured among the top 7% on CDP's 2020 Supplier Engagement
Leaderboard, recognising progress in working with suppliers to
address their emissions and driving science-based climate action
across AstraZeneca's value chain.
Pascal Soriot was listed as an official supporter of
the His Royal Highness The
Prince of Wales's 'Terra Carta', a ten-point strategy for business to move
towards a sustainable future by 2030. Launched at the One Planet
Summit in Paris, AstraZeneca will be one of the founding partners
looking to put nature, people and planet at the heart of
global-value creation.
In partnership with government and local non-governmental
organisations, AstraZeneca launched
the AZ Forest programme in
Indonesia, a commitment to
support a healthy environment and improve socio-economic
development and livelihoods for Indonesians by planting 20 million
trees in the country over the next five years. This commitment is
part of the global AZ Forest programme, announced at the WEF in
January 2020, pledging the plantation of 50 million trees by 2025,
in collaboration with One Tree Planted, a non-profit organisation
focused on global reforestation. The initiative supports the WEF's
'1T.org - The Champions for a Trillion Trees'
platform.
c) Ethics and transparency
In January 2021, the Company was recognised for its efforts in
promoting inclusion and diversity by the BGEI,
which tracks the performance of public companies committed to
disclosing their efforts to support gender equality through policy
development, representation and transparency. The Company was also
listed as a participant in ShareAction's WDI, an annual survey that aims to improve corporate
transparency and accountability on workforce issues and provide
companies and investors with comprehensive and comparable data to
help increase the provision of good jobs
worldwide.
During the period, AstraZeneca was named as a founding partner to
the WEF Partnering for
Racial Justice in Business Coalition, joining forces with 47 companies across 13
industries to eradicate racism in the workplace. The Company also
held its first Power of Diversity week, an initiative to support
all employees with the tools and knowledge needed to create a truly
inclusive culture.
As part of AstraZeneca's ongoing efforts to make sustainability
data transparent and accessible, a new analyst interactive
reporting (AIR) centre was
launched on the Company's website. AIR provides sustainability data
from 2015 onwards, covering global information from key performance
indicators for Access to healthcare, Environmental protection and
Ethics and transparency.
For more details on AstraZeneca's sustainability ambition, approach
and targets, please refer to the latest Sustainability Report
2019 and Sustainability Data
Summary 2019. Additional
information is available at astrazeneca.com/sustainability.
Research and development
As the COVID-19 pandemic persists, the Company will continue to
evaluate impacts on the initiation of clinical trials, ongoing
recruitment and follow-ups. It is prudent to assume that some
delays will arise as a consequence of the pandemic.
A comprehensive breakdown of AstraZeneca's pipeline of medicines in
human trials can be found in the latest clinical-trials appendix,
available on astrazeneca.com/investors.
Highlights of developments in the Company's late-stage pipeline
since the prior results announcement are shown
below:
Table 25: Late-stage pipeline
New
molecular entities and major lifecycle events for medicines in
Phase III trials or under regulatory review
|
22
|
Oncology
- Tagrisso -
NSCLC
- Imfinzi -
multiple cancers
- Lynparza -
multiple cancers
- Enhertu -
multiple cancers
- Calquence -
blood cancers
-
tremelimumab - multiple cancers
-
savolitinib - NSCLC[53]
-
capivasertib - breast, prostate cancer
-
monalizumab - head & neck cancer
-
camizestrant (AZD9833) - breast cancer
-
datopotamab deruxtecan - lung cancer
CVRM
- Farxiga -
multiple indications
-
roxadustat - anaemia in CKD
Respiratory & Immunology
- Fasenra -
multiple indications
- Breztri -
asthma
-
tezepelumab - severe asthma
-
PT027 - asthma
-
anifrolumab - lupus (SLE)
-
brazikumab - inflammatory bowel disease
-
nirsevimab - RSV
COVID-19
- C19VAZ -
SARS-CoV-2
-
AZD7442 - SARS-CoV-2
|
Total
projects
in
clinical development
|
145
|
|
Total
projects
in
total pipeline
|
171
|
|
Oncology
The Company presented data at the 62nd American Society of
Hematology (ASH) Annual Meeting and Exposition in November 2020 ,
the San Antonio Breast Cancer Symposium (SABCS) in December 2020
and the International Association for the Study of Lung Cancer
(IASLC) 2020 World Conference on Lung Cancer (WCLC), hosted by the
IASLC in January 2021. The data covered the haematology, breast and
lung cancer pipelines. Key data at the ASH meeting included 27
abstracts spanning five medicines and potential new medicines, and
eight different haematology conditions,
including Calquence, MEDI2228 (BCMA ADC) and AZD4320 (dual Bcl-2/xL
inhibitor).
Highlights from the SABCS symposium included updates
to Enhertu in the DESTINY-Breast01 Phase II trial and
camizestrant (AZD9833) (oral selective oestrogen receptor degrader)
in the SERENA-1 Phase I trial. Key data at the IASLC 2020 WCLC
included updated datopotamab deruxtecan Phase I data and new data
from the Enhertu DESTINY-Lung01 Phase II trial, both in
metastatic NSCLC.
a) Tagrisso
During the period, Tagrisso was approved in the US for the adjuvant
treatment of adult patients with early-stage EGFRm NSCLC after
tumour resection with curative intent, following the ADAURA Phase
III trial. The approval was granted under the US FDA Real-Time
Oncology Review pilot programme. Five other countries participated
in a concurrent submission and review process through the FDA's
Project Orbis.
Table 26:
Key Tagrisso Phase
III trials
Trial
|
Population
|
Design
|
Timeline
|
Status
|
NeoADAURA
|
Neo-adjuvant
EGFRm
NSCLC
|
Placebo
or
Tagrisso
|
FPCD[54]
Q1
2021
First
data anticipated
2022+
|
Recruitment
ongoing
|
ADAURA
|
Adjuvant
EGFRm NSCLC
|
Placebo
or Tagrisso
|
FPCD
Q4
2015
LPCD[55]
Q1
2019
|
Trial
unblinded early due to overwhelming efficacy
Regulatory
approval (US)
|
LAURA
|
Locally
advanced, unresectable EGFRm NSCLC
|
Placebo
or
Tagrisso
|
FPCD
Q4
2018
First
data anticipated
2022+
|
Recruitment
ongoing
|
FLAURA2
|
1st-line
EGFRm NSCLC
|
Tagrisso or
Tagrisso + platinum-based chemotherapy
doublet
|
FPCD
Q4
2019
First
data anticipated
2022+
|
Recruitment
ongoing
|
b) Imfinzi
In November 2020, Imfinzi was approved by the US FDA for an additional
dosing option, a 1,500mg fixed dose every four weeks in the
approved indications of unresectable, Stage III NSCLC after CRT and
previously treated advanced bladder cancer. This new option is
consistent with the approved Imfinzi dosing in ES-SCLC and will be available to
patients weighing more than 30kg as an alternative to the approved
weight-based dosing of 10mg/kg every two weeks.
During the period, Imfinzi received regulatory approval in the EU for
the aforementioned additional dosing option, 1,500mg fixed dose
every four weeks, in the approved indication of locally advanced,
unresectable Stage III NSCLC in adults whose tumours express
PD-L1[56] on
at least 1% of tumour cells and whose disease has not progressed
following platinum-based CRT.
Table 27:
Key Imfinzi Phase
III trials in lung cancer
Trial
|
Population
|
Design
|
Timeline
|
Status
|
AEGEAN
|
Neo-adjuvant
NSCLC
|
SoC[57] chemotherapy
+/- Imfinzi,
followed
by
surgery,
followed by placebo
or Imfinzi
|
FPCD
Q1
2019
First
data anticipated
2022+
|
Recruitment
ongoing
|
ADJUVANT
BR.31[58]
|
Stage
Ib-IIIa resected NSCLC
|
Placebo
or
Imfinzi
|
FPCD
Q1
2015
LPCD
Q1
2020
First
data anticipated
2022+
|
Recruitment
completed
|
MERMAID-1
|
Stage
II-III
resected
NSCLC
|
SoC
chemotherapy +/- Imfinzi
|
FPCDQ3
2020
First
data anticipated
2022+
|
Recruitmentongoing
|
MERMAID-2
|
Stage
II-III
NSCLC
with minimal residual disease
|
Placebo
or
Imfinzi
|
FPCDQ4
2020First data anticipated2022+
|
Recruitment
ongoing
|
PACIFIC-2
|
Stage
III unresectable locally advanced NSCLC
(concurrent
CRT)
|
Placebo
or
Imfinzi
|
FPCD
Q2
2018
LPCD
Q3
2019
First
data anticipated
H1
2021
|
Recruitment
completed
|
ADRIATIC
|
LS-SCLC
|
Concurrent
CRT,
followed
by
placebo
or
Imfinzi or
Imfinzi + treme
|
FPCD
Q4
2018
First
data anticipated
2022
|
Recruitment
ongoing
|
PEARL
|
Stage
IV, 1st-line NSCLC
|
SoC
chemotherapy or Imfinzi
|
FPCD
Q1
2017
LPCD
Q1
2019
First
data anticipated
2022
|
Recruitment
completed
|
POSEIDON
|
Stage
IV, 1st-line NSCLC
|
SoC
chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
|
FPCD
Q2
2017
LPCD
Q4
2018
OS data
anticipated
H1
2021
|
PFS[59] primary
endpoint met
|
CASPIAN
|
ES-SCLC
|
SoC
chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
|
FPCD
Q1
2017
LPCD
Q2
2018
|
OS
primary endpoint met for Imfinzi
OS
primary endpoint not met for Imfinzi + treme
Regulatory
approval
|
Table 28:
Key Imfinzi Phase
III trials in tumour types other than lung
cancer
Trial
|
Population
|
Design
|
Timeline
|
Status
|
POTOMAC
|
Non-muscle
invasive bladder cancer
|
SoC
BCG[60] or SoC BCG
+ Imfinzi
|
FPCD
Q4
2018LPCDQ3 2020
First
data
anticipated
2022+
|
Recruitmentcompleted
|
NIAGARA
|
Muscle-invasive
bladder cancer
|
Neo-adjuvant
cisplatin and gemcitabine SoC chemotherapy or SoC
+ Imfinzi, followed by
adjuvant placebo or Imfinzi
|
FPCD
Q4
2018
First
data
anticipated
2022+
|
Recruitment
ongoing
|
EMERALD-1
|
Locoregional
HCC[61]
|
TACE[62] followed
by placebo or
TACE
+ Imfinzi, followed
by Imfinzi +
bevacizumab or
TACE
+ Imfinzi
followed
by Imfinzi
|
FPCD
Q1
2019
First
data
anticipated
2022
|
Recruitment
ongoing
|
EMERALD-2
|
Locoregional
HCC at high risk of recurrence after surgery or radiofrequency
ablation
|
Adjuvant Imfinzi or Imfinzi +
bevacizumab
|
FPCD
Q2
2019
First
data anticipated
2022+
|
Recruitment
ongoing
|
CALLA
|
Locally
advanced cervical cancer
|
CRT or
CRT + Imfinzi,
followed by placebo or Imfinzi
|
FPCD
Q1
2019
LPCDQ4
2020
First
data anticipated
2022+
|
Recruitment
completed
|
MATTERHORN
|
Resectable
gastric and gastroesophageal cancer
|
Neoadjuvant Imfinzi +
FLOT chemotherapy +/- adjuvant Imfinzi
|
FPCDQ4
2020First data anticipated2022+
|
Recruitment
ongoing
|
KUNLUN
|
Locally
advanced, unresectable oesophageal squamous cell
carcinoma
|
Definitive
CRT or CRT + Imfinzi
|
FPCDQ4
2020First data anticipated2022+
|
Recruitmentongoing
|
NILE
|
Stage
IV, 1st-line cisplatin chemotherapy- eligible bladder
cancer
|
SoC
chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
|
FPCD
Q4
2018
First
data anticipated
2022+
|
Recruitment
ongoing
|
KESTREL
|
Stage
IV, 1st-line HNSCC[63]
|
SoC
or Imfinzi or Imfinzi + treme
|
FPCD
Q4
2015
LPCD
Q1
2017
|
Primary
endpoint not met
|
HIMALAYA
|
Stage
IV, 1st-line unresectable HCC
|
Sorafenib
or Imfinzi or Imfinzi + treme
|
FPCD
Q4
2017
LPCD
Q4
2019
First
data
anticipated
H2
2021
|
Recruitment
completed
Orphan
Drug Designation[64] (US)
|
TOPAZ-1
|
Stage
IV, 1st-line biliary-tract cancer
|
Gemcitabine
and cisplatin SoC chemotherapy or SoC + Imfinzi
|
FPCD
Q2
2019
First
data anticipated
2022
|
Recruitment
ongoing
|
c) Lynparza (multiple
cancers)
During the period, Lynparza received regulatory approval in the EU and
Japan for the additional indications of 1st-line maintenance
treatment with bevacizumab for patients with HRD+ advanced ovarian
cancer and patients with metastatic castration-resistant prostate
cancer with mutations, a subpopulation of homologous recombination
repair gene mutations (HRRm). Lynparza also received regulatory approval in Japan
as a maintenance treatment, after platinum-based chemotherapy for
patients with BRCAm unresectable pancreatic cancer, based on
positive results from the POLO Phase III trial.
Table 29:
Key Lynparza Phase
III trials
Trial
|
Population
|
Design
|
Timeline
|
Status
|
OlympiA
|
Adjuvant
BRCAm breast cancer
|
SoC
placebo or Lynparza
|
FPCD
Q2
2014
LPCD
Q2
2019
First
data anticipated
H1
2021
|
Recruitment
completed
|
PROfound
|
Metastatic
castration-resistant 2nd-line+ HRRm
prostate
cancer
|
SoC
(abiraterone or enzalutamide) or Lynparza
|
FPCD
Q2
2017
LPCD
Q4
2018
|
Primary
endpoint met
Regulatory
approval
|
PAOLA-1[65]
|
Advanced
1st-line
ovarian
cancer
|
Bevacizumab
maintenance or
bevacizumab
+
Lynparza maintenance
|
FPCD
Q2
2015
LPCD
Q2
2018
|
Primary
endpoint met
Regulatory
approval
|
DuO-O
|
Advanced
1st-line
ovarian
cancer
|
Chemotherapy
+
bevacizumab
or
chemotherapy
+
bevacizumab
+
Imfinzi +/-
Lynparza maintenance
|
FPCD
Q1 2019
First
data
anticipated
2022+
|
Recruitment
ongoing
|
DuO-E
|
Advanced
1st-line
endometrial
cancer
|
Chemotherapy
or
chemotherapy
+
Imfinzi + Imfinzi maintenance
or
chemotherapy
+
Imfinzi followed by Imfinzi + Lynparza maintenance
|
FPCD
Q2 2020
First
data
anticipated
2022+
|
Recruitment
ongoing
|
PROpel
|
Stage
IV, advanced, castration-resistant prostate cancer
|
Abiraterone
or
abiraterone
+
Lynparza
|
FPCD
Q4
2018
First
data
anticipated
H2
2021
|
Recruitment
ongoing
|
LYNK-003
|
Stage
IV, 1st-line colorectal cancer
|
Bevacizumab
+ 5-FU[66] maintenance
or bevacizumab + Lynparza maintenance
or Lynparza maintenance
|
First
data
anticipated
2022+
|
Initiating
|
d) Enhertu (breast
and other cancers)
In January 2021, Enhertu was approved by the US FDA for the treatment
of adult patients for 2nd line HER2+ gastric cancer. The approval
was based on the positive results from the randomised
DESTINY-Gastric01 Phase II trial.
During the period, AstraZeneca announced
that Enhertu had received regulatory approval in the EU
as a monotherapy for the treatment of adult patients with
unresectable or metastatic HER2+ cancer who have received two or
more prior anti-HER2 based regimens. The approval was based on
positive results from the single-arm DESTINY-Breast01 Phase II
trial.
Updated data were presented during the period, in a Spotlight
Poster Discussion at the aforementioned SABCS symposium, from
the Enhertu DESTINY-Breast01 Phase II trial in patients
with HER+ metastatic breast cancer, following two or more prior
HER2-based regimens. With a median duration of follow-up of 20.5
months, patients treated with Enhertu (5.4mg/kg) achieved an objective response
rate of 61.4% and a median duration of response of 20.8 months; the
median PFS was 19.4 months. In an exploratory landmark analysis of
OS, evaluated at 35% maturity, an estimated 74% of patients
remained alive at 18 months.
At the aforementioned IASLC 2020 WCLC, data were presented from the
DESTINY-Lung01 Phase II trial, highlighting the potential
of Enhertu in HER2-expressing metastatic NSCLC and in
metastatic HER2-mutant (HER2m) NSCLC. These are two groups of
patients for whom no HER2-directed medicine is currently
approved.
Table 30:
Key Enhertu trials
Trial
|
Population
|
Design
|
Timeline
|
Status
|
DESTINY-Breast01-U201
Phase
II
|
Stage
IV, HER2+[67] breast
cancer post trastuzumab emtansine
|
Enhertu
|
FPCD
Q4
2017
LPCD
Q4
2018
|
Primary
objective met
Breakthrough
Therapy Designation[68] (US)
Regulatory
approval (US, EU, JP)
|
DESTINY-Breast02-U301
Phase
III
|
Stage
IV, HER2+ breast cancer post trastuzumab emtansine
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2018
LPCDQ4
2020
First
data anticipated
H2
2021
|
Recruitment completed
|
DESTINY-Breast03-U302
Phase
III
|
Stage
IV, HER2+ breast cancer
|
Trastuzumab
emtansine or Enhertu
|
FPCD
Q4
2018LPCDQ2 2020
First
data anticipated
H2
2021
|
Recruitment completed
|
DESTINY-Breast04
Phase
III
|
Stage
IV, HER2-low breast cancer
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2018
LPCDQ4
2020
First
data anticipated
H2
2021
|
Recruitment completed
|
DESTINY-Breast06
Phase
III
|
Stage
IV, HER2-low breast cancer post endocrine therapy
|
SoC
chemotherapy or Enhertu
|
FPCDQ3
2020
First
data
anticipated
2022+
|
Recruitment
ongoing
|
DESTINY-Gastric01
Phase
II
|
Stage
IV, HER2+ gastric cancer
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2017
LPCD
Q2
2019
|
Primary
endpoint met
Breakthrough
Therapy Designation
(US)
Regulatory
approval (US, JP)
|
DESTINY-PanTumour02
Phase
II
|
HER2-expressing
tumours
|
Enhertu
|
FPCD
Q3
2020First data
anticipated
2022+
|
Recruitment
ongoing
|
DESTINY-
PanTumour01
Phase
II
|
HER2m
tumours
|
Enhertu
|
FPCDQ1
2021First data
anticipated
2022+
|
Recruitment
ongoing
|
e) Calquence
During the period, Calquence was approved in the EU for the treatment of
adult patients with CLL, and in Japan for R/R CLL, the most common
type of leukaemia in adults.
Positive high-level results from the ELEVATE-RR Phase III trial,
published during the period, showed Calquence met the primary endpoint demonstrating
non-inferior PFS for adults with previously treated, high-risk CLL,
compared to ibrutinib. The trial also met a key secondary endpoint
for safety, showing patients treated with Calquence had statistically significantly lower
incidence of atrial fibrillation, compared to patients treated with
ibrutinib. Overall, the safety and tolerability
of Calquence were consistent with the profile seen in the
broader Calquence clinical-development
programme.
At the aforementioned ASH meeting, a pooled analysis of CV safety
data for patients treated with Calquence for CLL, across four clinical trials, showed
a low incidence of cardiac adverse events (AEs), leading to
discontinuation. The analysis included patients with previously
untreated and R/R CLL treated with Calquence alone from the ELEVATE-TN and ASCEND Phase
III trials, as well as the 15-H-0016 Phase II trial and ACE-CL-001
Phase I/II trial. In the analysis, 129 patients (17%) reported a
cardiac AE of any grade at a median follow up of 25.9 months, and
seven patients (0.9%) discontinued treatment due to cardiac
AEs.
At the same meeting, long-term follow-up results from the positive
ACE-LY-004 Phase II trial were also presented. Data showed patients
with R/R MCL treated with Calquence remained progression-free for a median of 22
months, with median OS not yet reached at three years of follow-up.
The safety and tolerability profile remained
consistent.
f) Datopotamab deruxtecan
At the aforementioned IASLC 2020 WCLC, updated data were presented
from the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan
in metastatic NSCLC, supporting its potential to redefine treatment
outcomes in advanced NSCLC.
Table 31: Datopotamab deruxtecan
Trial
|
Population
|
Design
|
Timeline
|
Status
|
TROPION-LUNG01
Phase
III
|
Stage
IV, NSCLC
|
SoC
chemotherapy or datopotamab deruxtecan
|
First
data anticipated
2022+
|
Initiating
|
CVRM
a) Farxiga (HF,
CKD)
In November 2020, Forxiga was approved in the EU and Japan and China
for the treatment of symptomatic chronic HFrEF in adults with and
without T2D. The approvals were based on results from the DAPA-HF
Phase III trial where Farxiga, on top of SoC, reduced the composite of
cardiovascular death or worsening of heart failure by
26%. Farxiga was approved in the US for the same
indication in May 2020.
During the period, Forxiga received regulatory submission acceptance in
the EU and China for the treatment of CKD. The submissions were
based on results from the DAPA-CKD Phase III trial
where Farxiga, on top of SoC, reduced the composite measure of
worsening of renal function or risk of CV or renal death by 39%,
compared to placebo in patients with CKD stages 2-4 and elevated
urinary albumin excretion. In January
2021, Farxiga was
accepted for regulatory review and granted priority review in Japan
and the US. The Prescription Drug User Fee Action date, the day the
US FDA targets for regulatory decision, is anticipated to be during
the second quarter of 2021.
b) Brilinta (stroke)
In November 2020, the Company received US FDA approval
for Brilinta to reduce the risk of stroke in patients
with an acute ischaemic stoke or high-risk transient ischaemic
attack. The approval was based on results from the THALES Phase III
trial.
Table 32: Key large CVRM Phase III
outcomes trials
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
Farxiga
|
|
DAPA-HF
|
c.4,500
patients with HFrEF, with and without T2D
|
SoC +
placebo or SoC + Farxiga 10mg or 5mg QD[69]
|
Time to
first occurrence of CV death or hospitalisation due to HF
or
an
urgent HF visit
|
FPCD
Q1
2017
LPCD
Q4
2018
|
Primary
endpoint met
Regulatory
approval
|
DELIVER
|
c.4,700
patients with HF (HFpEF) with and without T2D
|
Placebo
or Farxiga 10mg
QD
|
Time to
first occurrence of CV death or worsening HF
|
FPCD
Q4
2018
First
data anticipatedH2 2021
|
Recruitment
ongoing
Fast
Track[70] designation
(US)
|
DAPA-CKD
|
c.4,000
patients with CKD, with and without T2D
|
Placebo
or Farxiga 10mg
or 5mg QD
|
Time to
first occurrence of ≥ 50% sustained decline in eGFR or
reaching ESRD or CV death or renal death
|
FPCD
Q1
2017
LPCD
Q1
2020
|
Trial
stopped early based on recommendation from an IDMC[71]
Primary
endpoint and secondary endpoints met
Fast
Track designation (US)
|
DAPA-MI
|
c.6,400
patients with confirmed MI, either STEMI or NSTEMI, within the
preceding 7 days
|
Placebo
or Farxiga 10mg
QD
|
Time to
the first occurrence of any of the components of this composite:
hospitalisation for HF or CV death
|
FPCD
Q4
2020First data anticipated2022+
|
Recruitment
ongoing
|
Brilinta
|
|
THEMIS
|
c.19,000
patients with T2D and CAD without a history of MI or
stroke
|
Aspirin
plus placebo or aspirin plus Brilinta 60mg BID[72]
|
Composite
of CV death, non-fatal MI and non-fatal stroke
|
FPCD
Q1
2014
LPCD
Q2
2016
|
Primary
endpoint met
Regulatory
approval (US)
|
THALES
|
c.11,000
patients with acute ischaemic stroke[73] or transient
ischaemic attack
|
Aspirin
plus placebo or aspirin plus Brilinta 90mg BID
|
Prevention
of the composite of subsequent stroke and death at 30
days
|
FPCD
Q1
2018
LPCD
Q4
2019
|
Primary
endpoint met
Regulatory
approval (US)
|
c) Lokelma (hyperkalaemia)
In November 2020, the China National Medical Products
Administration (NMPA) approved a dosing-label update
for Lokelma to include patients with hyperkalaemia on
chronic haemodialysis. The approval was based on results from the
DIALIZE Phase IIIb trial, the first-ever randomised,
placebo-controlled trial to evaluate a potassium binder in patients
on stable haemodialysis. The trial showed sustained potassium
control pre-dialysis for patients
receiving Lokelma,
compared with placebo. In December 2019, the NMPA
approved Lokelma to treat adult patients with
hyperkalaemia.
d) Roxadustat (anaemia)
In December 2020, the US FDA requested further clarifying analyses
to complete its New Drug Application (NDA) review for roxadustat.
AstraZeneca and FibroGen submitted the analyses before the end of
the year, to assist with the completion of labelling discussions.
The NDA remains under regulatory review, and the US FDA has set a
new action date of 20 March 2021.
In November 2020, the Company and FibroGen presented new data on
roxadustat at the aforementioned ASH meeting. The multiple trials
evaluated the clinical effectiveness and safety profile of
roxadustat in both the dialysis-dependent and non-dialysis
dependent anaemia of CKD patient populations. Data were also
presented assessing the medicine's efficacy in anaemia associated
with lower-risk MDS, regardless of baseline factors; in
approximately one in three patients, MDS leads to acute myeloid
leukaemia.
Respiratory & Immunology
a) Symbicort (mild
asthma)
In January 2021, AstraZeneca's Symbicort
Turbuhaler (budesonide/formoterol 160/4.5mcg) was
approved in China as an anti-inflammatory reliever to be taken as
needed in response to symptoms to achieve asthma control in
patients with mild asthma aged 12 years and older. This new
indication for Symbicort aligned to the latest National Asthma
Guidelines from the Chinese Thoracic Society, updated in Q4 2020,
which recommended a low dose corticosteroid-formoterol combination
therapy, taken as-needed, as the preferred reliever therapy in mild
asthma.
b) Breztri (COPD)
During the period, Breztri, under the name Trixeo, received regulatory approval in the EU,
following the receipt in Q3 2020 of a positive opinion from the
EMA's Committee for Medicinal Products for Human
Use. Trixeo is indicated for the maintenance treatment
in adult patients with moderate to severe chronic COPD who are not
adequately treated by a combination of an ICS and a LABA, or a
combination of a LABA and a long-acting muscarinic
antagonist.
c) Fasenra (eosinophil-driven
diseases)
Table 33:
Key Fasenra lifecycle
management Phase III trials
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
OSTRO
|
Patients
aged 18-75 years with severe bilateral nasal polyps; symptomatic,
despite SoC
|
Placebo
or Fasenra 30mg
Q8W[74] SC[75]
|
Nasal-polyps
burden and reported nasal blockage
|
FPCD
Q1
2018
LPCD
Q2
2019
|
Co-primary
endpoints met
|
RESOLUTE
|
Patients
with moderate to very severe COPD with a history of frequent COPD
exacerbations and elevated peripheral blood
eosinophils
|
Placebo
or Fasenra 100mg
Q8W SC
|
Annualised
rate of moderate or severe COPD exacerbations
|
FPCD
Q4
2019
Data
anticipated 2022+
|
Recruitment
ongoing
|
MANDARA
|
Eosinophilic
granulomatosis with polyangiitis[76]
|
Mepolizumab
3x100mg Q4W or Fasenra 30mg
|
Proportion
of patients who achieve remission, defined as a score[77] =0 and an
OCS dose ≤4 mg/day at weeks 36 and 48
|
FPCD
Q4
2019
Data
anticipated
2022+
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
NATRON
|
HES[78]
|
Placebo
or Fasenra 30mg
Q4W SC
|
Time to
HES worsening flare or any cytotoxic and/or immuno-suppressive
therapy increase or hospitalisation
|
FPCD
Q3
2020
Data
anticipated 2022
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
MESSINA
|
Eosinophilic
oesophagitis[79]
|
Placebo
or Fasenra 30mg
Q4W SC
|
Proportion
of patients with a histologic response[80]
Changes
from baseline in dysphagia[81] PRO[82]
|
FPCD
Q4
2020
Data
anticipated 2022
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
FJORD
|
BP[83]
|
Placebo
or Fasenra 30mg
Q4W SC
|
Proportion
of patients with partial or
complete
remission of BP whilst off OCS for ≥2 months
at Week
36
|
Data
anticipated 2022+
|
Recruitment
ongoing
|
d) Anifrolumab (lupus: SLE)
During the period, a new analysis of the TULIP Phase III
clinical-trial programme showed that treatment with anifrolumab
resulted in a greater reduction in disease flares while having a
sustained reduction in doses of OCS compared to placebo, with both
groups of patients receiving SoC. The data were presented in
November 2020 at ACR Convergence 2020, the annual meeting of the
American College of Rheumatology.
The new pooled analysis showed that 40% of patients treated with
anifrolumab, plus SoC, had a sustained reduction in OCS use without
experiencing a disease flare through 52 weeks (versus 17.3% in
placebo plus SoC). Treatment with anifrolumab was associated with
lower overall flare rates compared to placebo, and also on the skin
and in the mouth (mucocutaneous), as well as in joints
(musculoskeletal), the two organ domains most frequently affected
at the start of the trial.
During the period, the Company completed a regulatory submission
for anifrolumab to the Japanese Pharmaceuticals and Medical Devices
Agency for the treatment of adult patients with moderate to severe
SLE. The submission was based on results from the two TULIP Phase
III trials and the MUSE Phase II trial, in which a reduction in
disease activity and OCS use, and improvement in lupus skin
activity, were observed with anifrolumab added to SoC, compared to
placebo and SoC. A regulatory decision is expected in the second
half of 2021. Anifrolumab is also currently under regulatory review
in the US, in the EU and in other countries.
e) Tezepelumab (severe asthma)
During the period, AstraZeneca, along with its collaborator Amgen
Inc., announced positive results from the NAVIGATOR Phase III trial
for the potential new medicine tezepelumab in patients with severe,
uncontrolled asthma.
NAVIGATOR met the primary endpoint with tezepelumab added to SoC,
demonstrating a statistically significant and clinically meaningful
reduction in the annualised asthma exacerbation rate (AAER) over 52
weeks in the overall patient population, compared to placebo when
added to SoC, namely medium- or high- ICS plus at least one
additional controller medication with or without OCS.
In a subgroup of patients, with baseline eosinophil counts of less
than 300 cells per microlitre, the trial also met the primary
endpoint, with tezepelumab demonstrating a statistically
significant and clinically meaningful reduction in AAER. Similar
reductions in AAER were observed in a subgroup of patients with
baseline eosinophil counts of less than 150 cells per microlitre.
Tezepelumab was very well tolerated in patients with severe asthma.
Preliminary analyses showed no clinically meaningful differences in
safety results between the tezepelumab and placebo
groups.
High-level results from the SOURCE Phase III trial also became
available, which assessed the efficacy and safety of tezepelumab
compared to placebo in 150 severe asthma patients who required
maintenance use of OCS on top of SoC. The 48-week trial, which is
not required for regulatory submission, did not meet the primary
endpoint of a statistically significant reduction in the daily OCS
dose, without loss of asthma control, with tezepelumab compared to
placebo. Tezepelumab's effect on other efficacy parameters was
similar to those observed in previous trials, including the
registrational NAVIGATOR Phase III trial.
Results from the NAVIGATOR trial will be presented at this year's
American Academy of Allergy Asthma and Immunology Annual Meeting.
Data from the SOURCE trial will be presented at a forthcoming
medical meeting.
Table 34: Key tezepelumab Phase III trials
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
NAVIGATOR
|
Severe
asthma
|
Placebo
or tezepelumab 210mg Q4W SC
|
Annual
asthma exacerbation rate
|
FPCD
Q1
2018
LPCD
Q3
2019
|
Primary
endpoint met
Breakthrough
Therapy Designation
(US)
|
f) PT027 (asthma)
PT027 is a budesonide/albuterol metered-dose inhaler, a potential
new medicine for the treatment of asthma as an anti-inflammatory
reliever in development in collaboration with Avillion LLP. During
the period, the TYREE Phase III trial achieved its primary
endpoint. TYREE is a 60 patient, multicentre, randomised,
double-blind, single-dose, two-period, crossover trial to evaluate
the efficacy and safety of PT027 160/180mcg versus placebo on
exercise-induced bronchoconstriction in adult and adolescent
patients with asthma. In the trial, PT027 demonstrated superiority
over placebo for the primary endpoint of the maximum percentage
fall from post-dose, pre-exercise baseline in forced expiratory
volume in one second observed up to 60 minutes, post-exercise
challenge.
Results from the MANDALA and DENALI Phase III trials, intended for
regulatory submission in asthma, are anticipated in the second half
of 2021.
g) Nirsevimab (RSV)
In January 2021, the China Center for Drug Evaluation (CDE) under
the NMPA granted Breakthrough Therapy Designation for nirsevimab,
an extended half-life monoclonal antibody being in development as a
passive immunisation for the prevention of lower respiratory-tract
infection caused by RSV in all infants. This designation was based
on the unmet need for a preventative option against RSV for all
infants in China where none currently exists and should help to
expedite the regulatory review of nirsevimab, following regulatory
submission in the country.
COVID-19
a) COVID-19
Vaccine AstraZeneca (C19VAZ)
(SARS-CoV-2)
During the period, the University of Oxford and AstraZeneca
continued to enrol participants into the global clinical trials of
the recombinant adenovirus vaccine, C19VAZ. Trials in the UK, Brazil, South Africa and the
US are fully recruited and total enrolment across the trials
amounts to over 55,000 participants.
The results of an interim analysis of the Phase III programme,
conducted by the University of Oxford with C19VAZ, were peer-reviewed and published
in The
Lancet in
December 2020, demonstrating that the vaccine is safe and effective
at preventing symptomatic COVID-19 and that it protects against
severe disease and hospitalisation.
In December 2020, the UK MHRA provided authorisation for the
emergency supply of C19VAZ for the active immunisation of individuals
aged 18 years or older. The authorisation recommended two full
doses administered with an interval of between four and 12 weeks.
This regimen was shown in clinical trials to be safe and effective
at preventing symptomatic COVID-19, with no severe cases and no
hospitalisations more than 14 days after the second dose.
Additional data on dosing intervals were included in
the Summary of Product
Characteristics published
by the UK MHRA to coincide with the
authorisation.
In January 2021, C19VAZ received conditional marketing approval from
the EMA. Additional authorisations for emergency use have also been
provided by regulatory authorities in a number of individual
countries, including Argentina, Mexico and Morocco, and our
sub-licensee Serum Institute of India has received emergency use
authorisation for supply in India.
During the period, the primary analysis, conducted by the
University of Oxford, of late-stage clinical trials in the UK,
Brazil and South Africa was published as a preprint
in The
Lancet confirming C19VAZ is safe and effective at preventing
COVID-19, with no severe cases and no hospitalisations, more than
22 days after the first dose. The results demonstrated vaccine
efficacy of 76% (CI 0.59-0.86) after a first dose, with protection
maintained to the second dose. With an inter-dose interval of 12
weeks or more, vaccine efficacy increased to 82% (CI
0.63-0.92).
In February 2021, the WHO's SAGE recommended two doses
of C19VAZ, in individuals aged 18 years and above,
including individuals aged 65 and over. The WHO noted that the
manufacturer's labelled dosing interval is four to 12 weeks and
recommended an interval of eight to 12 weeks between doses. This
dosing regimen was shown in clinical trials to be safe and
effective in preventing symptomatic COVID-19, with no severe cases
and no hospitalisations more than 14 days after the second dose. In
addition, the WHO SAGE recommended C19VAZ in countries where new variants, including
the South African variant, are prevalent.
Data on the efficacy of C19VAZ against new variants of the SARS-CoV-2 virus
were also published in
preprint during the
period, showing that the vaccine remains effective against the
B.1.1.7 Kent variant. The University of Oxford, however,
subsequently announced that
a separate exploratory analysis of the COV005 Phase I/II South
Africa trial, to be published in preprint in due course, showed
that the vaccine had limited efficacy against mild-moderate disease
caused by the B.1.351 South African variant. It was not possible to
ascertain efficacy against severe disease and hospitalisation
caused by this variant, given that subjects in the trial were
predominantly young, healthy adults.
In collaboration with the University of Oxford, AstraZeneca is
focused on adapting C19VAZ to new disease strains if required and hopes
to reduce the time needed to reach production at scale to between
six to nine months, by utilising existing clinical data and
optimising its established supply chain.
Further data continue to accrue across the clinical-trial
programme, including efficacy, the effect of different dosing
intervals, the impact of new variants of SARS-CoV-2 and the
duration of protection offered by C19VAZ; we anticipate these be published in due course.
AstraZeneca continues to share data with other regulatory
authorities around the world.
Table 35: Key C19VAZ trials in COVID-19
Trial
|
Population
|
Design
|
Timeline
|
Status
|
COV001[84]
(UK)
Phase
I/II
|
Protection
against COVID-19 in participants aged 18-55
|
MenACWY
or C19VAZ
|
FPCD
Q2
2020
LPCD
Q2
2020
|
Initial
data readout
Recruitment completed
Regulatory approval (UK, EU)
|
COV00283
(UK)
Phase
II/III
|
Protection
against COVID-19 in participants aged 18-55, 55+
|
MenACWY
or C19VAZ
|
FPCD
Q2
2020
LPCD
Q4
2020
|
Initial
data readout
Recruitment completed
Regulatory approval (UK, EU)
|
COV003
(Brazil)
Phase
II/III
|
Protection
against COVID-19 in participants aged 18-55
|
MenACWY
or C19VAZ
|
FPCD
Q2
2020
LPCD
Q4
2020
|
Initial
data readout
Recruitment completed
Regulatory approval (UK, EU)
|
COV005ChAdOx1
nCoV-19 ZA[85]
(South
Africa)
Phase
I/II
|
Protection
against COVID-19 in participants aged 18-65
HIV+[86] subgroup
|
Placebo
or C19VAZ
|
FPCD
Q2
2020
LPCD
Q4
2020
First
data anticipated
H1
2021
|
Recruitment completed
|
D8110C00001
(US,
global)
Phase
III
|
Protection
against
COVID-19
in participants aged 18+
|
Placebo
or C19VAZ
|
FPCD
Q3
2020
First
data anticipated
H1
2021
|
Recruitment completed
|
b) AZD7442 (long-acting antibody combination for the
prevention and treatment of COVID-19)
AZD7442, a long-acting antibody (LAAB) combination therapy for the
prevention and treatment of COVID-19, has advanced into five Phase
III clinical trials.
The LAAB combination has been engineered with AstraZeneca's
proprietary half-life extension technology, which triples the
durability of its action compared to conventional antibodies and
with a further modification to reduce binding of the Fc
(fragment-crystallisable) portion of the antibody to Fc receptors
on other cells to reduce the theoretical risk of antibody-dependent
enhanced disease.
Table 36: Key AZD7442 Phase II/III
trials in COVID-19
Trial
|
Population
|
Design
|
Timeline
|
Status
|
PROVENT
|
Protection
against
COVID-19
(prophylaxis)
|
Placebo
or
AZD7442 300mg IM[87]
|
FPCD
Q4
2020
First
data anticipated
H2
2021
|
Recruitment
ongoing
|
STORM
CHASER
|
Protection
against
COVID-19
(post-exposure
prophylaxis)
|
Placebo
or
AZD7442 300mg IM
|
FPCD
Q4
2020
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
TACKLE
|
COVID-19
(outpatient treatment)
|
Placebo
or
AZD7442 600mg IM
|
FPCD
Q1
2021
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
ACTIV-2[88]
|
COVID-19
(outpatient treatment)
|
Placebo
or
AZD7442
|
FPCD
Q1
2021
|
Initiating
|
ACTIV-387
|
COVID-19
(inpatient
treatment)
|
Placebo
or
AZD7442
|
FPCD
Q1
2021
|
Recruitment
ongoing
|
c) Other new and existing medicines in the treatment of
COVID-19
During 2020, as well as developing preventative approaches against
the SARS-CoV-2 virus, the Company also initiated clinical trials,
detailed in the table below, to evaluate AstraZeneca's new and
existing medicines to treat the infection, by suppressing the
body's overactive immune response or protecting from serious
complications, such as organ failure.
In November 2020, AstraZeneca announced that the CALAVI Phase II
trials for Calquence, in patients hospitalised with respiratory
symptoms of COVID-19, did not meet the primary efficacy endpoint.
The addition of Calquence to best supportive care did not increase the
proportion of patients who remained alive and free of respiratory
failure.
The Company is continuing to evaluate
whether Farxiga can reduce organ failure in COVID-19 in the
DARE-19 Phase III trial. Farxiga is also being evaluated, in combination with
ambrisentan, in the Cambridge University Hospitals NHS Trust's
TACTIC-E Phase II trial. Farxiga is an oral SGLT2 inhibitor, principally used
as a treatment for T2D, that has demonstrated benefits in HF and
CKD in patients both with and without T2D.
AstraZeneca has joined the UK Government's ACCORD proof-of-concept
clinical-trial platform, to speed the development of medicines for
patients with COVID-19, evaluating the use of IL33 monoclonal
antibody medicine MEDI3506 in suppressing the overactive immune
response that can characterise COVID-19. The Company is also
supplying Pulmicort and Symbicort to externally sponsored research programmes,
including the trials detailed in the table
below.
Table 37: Other key trials in
COVID-19[89]
Trial
|
Population
|
Design
|
Timeline
|
Status
|
Farxiga
|
DARE-19[90]
Phase
III
|
COVID-19
|
Current
SoC
or
current SoC +
Farxiga
|
FPCD
Q2
2020
LPCD
Q1
2021
First
data anticipated
H1
2021
|
Recruitment
completed
|
TACTIC-E[91]
Phase
II
|
COVID-19
|
Current
SoC or current SoC + Farxiga + ambrisentan
|
FPCD
Q4
2020
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
Symbicort
|
INHASCO[92]
Phase
IIIa
|
COVID-19
|
Current
SoC or SoC + Symbicort
|
FPCD
Q2
2020
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
Pulmicort
|
TACTIC-COVID[93]
Phase
IIIa
|
COVID-19
|
Current
SoC or SoC + Pulmicort
|
FPCD
Q2
2020
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
MEDI3506 (IL33 monoclonal antibody)
|
ACCORD[94]
Phase
II
|
COVID-19
|
Current
SoC or current SoC + MEDI3506
|
FPCD
Q2
2020
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
For more details on the development pipeline, including anticipated
timelines for regulatory submission/acceptances, please refer to
the latest Clinical Trials
Appendix available
on astrazeneca.com.
For Alexion pipeline updates, please visit alexion.com.
Condensed Financial Statements
Table 38: Condensed consolidated statement of comprehensive income
- FY 2020
For the year ended 31 December
|
2020
|
2019
|
$m
|
$m
|
Total Revenue
|
26,617
|
24,384
|
Product Sales
|
25,890
|
23,565
|
Collaboration Revenue
|
727
|
819
|
|
|
|
Cost of Sales
|
(5,299)
|
(4,921)
|
|
|
|
Gross Profit
|
21,318
|
19,463
|
|
|
|
Distribution costs
|
(399)
|
(339)
|
Research and development expense
|
(5,991)
|
(6,059)
|
Selling, general and administrative costs
|
(11,294)
|
(11,682)
|
Other operating income and expense
|
1,528
|
1,541
|
|
|
|
Operating Profit
|
5,162
|
2,924
|
Finance income
|
87
|
172
|
Finance expense
|
(1,306)
|
(1,432)
|
Share of after-tax losses in associates and joint
ventures
|
(27)
|
(116)
|
|
|
|
Profit Before Tax
|
3,916
|
1,548
|
Taxation
|
(772)
|
(321)
|
Profit for the period
|
3,144
|
1,227
|
|
|
|
Other comprehensive income
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
Remeasurement of the defined benefit pension liability
|
(168)
|
(364)
|
Net gains/(losses) on equity investments measured at fair value
through other comprehensive income
|
938
|
(28)
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
(1)
|
(5)
|
Tax on items that will not be reclassified to profit or
loss
|
(81)
|
21
|
|
688
|
(376)
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
Foreign exchange arising on consolidation
|
443
|
40
|
Foreign exchange arising on designated borrowings in net investment
hedges
|
573
|
(252)
|
Fair value movements on cash flow hedges
|
180
|
(101)
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
(254)
|
52
|
Fair value movements on derivatives designated in net investment
hedges
|
8
|
35
|
Gains/(costs) of hedging
|
9
|
(47)
|
Tax on items that may be reclassified subsequently to profit or
loss
|
(39)
|
38
|
|
920
|
(235)
|
Other comprehensive income/(loss) for the period, net of
tax
|
1,608
|
(611)
|
Total comprehensive income for the period
|
4,752
|
616
|
|
|
|
Profit attributable to:
|
|
|
Owners of the Parent
|
3,196
|
1,335
|
Non-controlling interests
|
(52)
|
(108)
|
|
3,144
|
1,227
|
Total comprehensive income attributable to:
|
|
|
Owners of the Parent
|
4,804
|
723
|
Non-controlling interests
|
(52)
|
(107)
|
|
4,752
|
616
|
Basic earnings per $0.25 Ordinary Share
|
$2.44
|
$1.03
|
Diluted earnings per $0.25 Ordinary Share
|
$2.44
|
$1.03
|
|
|
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,312
|
1,301
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,313
|
1,301
|
Table 39: Condensed consolidated
statement of comprehensive income - Q4 2020[95]
For the quarter ended 31 December
|
2020
|
2019
|
$m
|
$m
|
Total Revenue
|
7,410
|
6,664
|
Product Sales
|
7,011
|
6,250
|
Collaboration Revenue
|
399
|
414
|
|
|
|
Cost of Sales
|
(1,525)
|
(1,378)
|
|
|
|
Gross Profit
|
5,885
|
5,286
|
|
|
|
Distribution costs
|
(109)
|
(92)
|
Research and development expense
|
(1,719)
|
(2,091)
|
Selling, general and administrative costs
|
(3,210)
|
(3,026)
|
Other operating income and expense
|
640
|
500
|
|
|
|
Operating Profit
|
1,487
|
577
|
Finance income
|
7
|
39
|
Finance expense
|
(321)
|
(351)
|
Share of after-tax losses in associates and joint
ventures
|
(6)
|
(25)
|
|
|
|
Profit Before Tax
|
1,167
|
240
|
Taxation
|
(162)
|
37
|
Profit for the period
|
1,005
|
277
|
|
|
|
Other comprehensive income
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
Remeasurement of the defined benefit pension liability
|
23
|
(213)
|
Net losses on equity investments measured at fair value through
other comprehensive income
|
(36)
|
108
|
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
|
(11)
|
-
|
|
(24)
|
(109)
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
Foreign exchange arising on consolidation
|
564
|
425
|
Foreign exchange arising on designated borrowings in net investment
hedges
|
428
|
239
|
Fair value movements on cash flow hedges
|
178
|
55
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
(139)
|
(57)
|
Fair value movements on derivatives designated in net investment
hedges
|
(31)
|
-
|
Costs of hedging
|
(1)
|
(12)
|
Tax on items that may be reclassified subsequently to profit or
loss
|
(46)
|
(24)
|
|
953
|
626
|
Other comprehensive income for the period, net of tax
|
929
|
517
|
Total comprehensive income for the period
|
1,934
|
794
|
|
|
|
Profit attributable to:
|
|
|
Owners of the Parent
|
1,012
|
313
|
Non-controlling interests
|
(7)
|
(36)
|
|
1,005
|
277
|
Total comprehensive income attributable to:
|
|
|
Owners of the Parent
|
1,940
|
830
|
Non-controlling interests
|
(6)
|
(36)
|
|
1,934
|
794
|
Basic earnings per $0.25 Ordinary Share
|
$0.78
|
$0.24
|
Diluted earnings per $0.25 Ordinary Share
|
$0.78
|
$0.24
|
|
|
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,312
|
1,312
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,313
|
1,312
|
Table 40: Condensed consolidated
statement of financial position
|
At 31 Dec 2020
|
At 31 Dec 2019
|
$m
|
$m
|
Assets
|
|
|
Non-current assets
|
|
|
Property, plant and equipment
|
8,251
|
7,688
|
Right-of-use assets
|
666
|
647
|
Goodwill
|
11,845
|
11,668
|
Intangible assets
|
20,947
|
20,833
|
Investments in associates and joint ventures
|
39
|
58
|
Other investments
|
1,108
|
1,401
|
Derivative financial instruments
|
171
|
61
|
Other receivables
|
720
|
740
|
Deferred tax assets
|
3,438
|
2,718
|
|
|
|
|
47,185
|
45,814
|
|
|
|
Current assets
|
|
|
Inventories
|
4,024
|
3,193
|
Trade and other receivables
|
7,022
|
5,761
|
Other investments
|
160
|
849
|
Derivative financial instruments
|
142
|
36
|
Income tax receivable
|
364
|
285
|
Cash and cash equivalents
|
7,832
|
5,369
|
Assets held for sale
|
-
|
70
|
|
19,544
|
15,563
|
|
|
|
Total assets
|
66,729
|
61,377
|
|
|
|
Liabilities
|
|
|
Current liabilities
|
|
|
Interest-bearing loans and borrowings
|
(2,194)
|
(1,822)
|
Lease liabilities
|
(192)
|
(188)
|
Trade and other payables
|
(15,785)
|
(13,987)
|
Derivative financial instruments
|
(33)
|
(36)
|
Provisions
|
(976)
|
(723)
|
Income tax payable
|
(1,127)
|
(1,361)
|
|
(20,307)
|
(18,117)
|
Non-current liabilities
|
|
|
Interest-bearing loans and borrowings
|
(17,505)
|
(15,730)
|
Lease liabilities
|
(489)
|
(487)
|
Derivative financial instruments
|
(2)
|
(18)
|
Deferred tax liabilities
|
(2,918)
|
(2,490)
|
Retirement benefit obligations
|
(3,202)
|
(2,807)
|
Provisions
|
(584)
|
(841)
|
Other payables
|
(6,084)
|
(6,291)
|
|
(30,784)
|
(28,664)
|
Total liabilities
|
(51,091)
|
(46,781)
|
|
|
|
Net assets
|
15,638
|
14,596
|
|
|
|
Equity
|
|
|
Capital and reserves attributable to equity holders of the
Parent
|
|
|
Share
capital
|
328
|
328
|
Share
premium account
|
7,971
|
7,941
|
Other
reserves
|
2,024
|
2,046
|
Retained earnings
|
5,299
|
2,812
|
|
|
|
|
15,622
|
13,127
|
|
|
|
Non-controlling interests
|
16
|
1,469
|
Total equity
|
15,638
|
14,596
|
Table 41: 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 2019
|
317
|
4,427
|
2,041
|
5,683
|
12,468
|
1,576
|
14,044
|
|
|
|
|
|
|
|
|
Adoption of new accounting standards
|
-
|
-
|
-
|
54
|
54
|
-
|
54
|
Profit for the period
|
-
|
-
|
-
|
1,335
|
1,335
|
(108)
|
1,227
|
Other comprehensive loss
|
-
|
-
|
-
|
(612)
|
(612)
|
1
|
(611)
|
Transfer to other reserves
|
-
|
-
|
5
|
(5)
|
-
|
-
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(3,579)
|
(3,579)
|
-
|
(3,579)
|
Issue of Ordinary Shares
|
11
|
3,514
|
-
|
-
|
3,525
|
-
|
3,525
|
Share-based payments charge for the period
|
-
|
-
|
-
|
259
|
259
|
-
|
259
|
Settlement of share plan awards
|
-
|
-
|
-
|
(323)
|
(323)
|
-
|
(323)
|
|
|
|
|
|
|
|
|
Net movement
|
11
|
3,514
|
5
|
(2,871)
|
659
|
(107)
|
552
|
|
|
|
|
|
|
|
|
At 31 Dec 2019
|
328
|
7,941
|
2,046
|
2,812
|
13,127
|
1,469
|
14,596
|
|
|
|
|
|
|
|
|
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[96]
|
-
|
-
|
(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
|
Table 42: Condensed consolidated statement of cash
flows
For the year ended 31 December
|
2020
|
2019
|
$m
|
$m
|
Cash flows from operating activities
|
|
|
Profit Before Tax
|
3,916
|
1,548
|
Finance income and expense
|
1,219
|
1,260
|
Share of after-tax losses of associates and joint
ventures
|
27
|
116
|
Depreciation, amortisation and impairment
|
3,149
|
3,762
|
Decrease/(increase) in working capital and short-term
provisions
|
361
|
(346)
|
Gains on disposal of intangible assets
|
(1,030)
|
(1,243)
|
Fair value movements on contingent consideration arising from
business combinations
|
(272)
|
(614)
|
Non-cash and other movements
|
(276)
|
378
|
|
|
|
Cash generated from operations
|
7,094
|
4,861
|
Interest paid
|
(733)
|
(774)
|
Tax paid
|
(1,562)
|
(1,118)
|
|
|
|
Net cash inflow from operating activities
|
4,799
|
2,969
|
|
|
|
Cash flows from investing activities
|
|
|
Payment of contingent consideration from business
combinations
|
(822)
|
(709)
|
Purchase of property, plant and equipment
|
(961)
|
(979)
|
Disposal of property, plant and equipment
|
106
|
37
|
Purchase of intangible assets
|
(1,645)
|
(1,481)
|
Disposal of intangible assets
|
951
|
2,076
|
Movement
in profit-participation liability
|
40
|
150
|
Purchase of non-current asset investments
|
(119)
|
(13)
|
Disposal of non-current asset investments
|
1,381
|
18
|
Movement in short-term investments, fixed deposits and other
investing instruments
|
745
|
194
|
Payments to associates and joint ventures
|
(8)
|
(74)
|
Interest received
|
47
|
124
|
|
|
|
Net cash outflow from investing activities
|
(285)
|
(657)
|
|
|
|
Net cash inflow before financing activities
|
4,514
|
2,312
|
|
|
|
Cash flows from financing activities
|
|
|
Proceeds from issue of share capital
|
30
|
3,525
|
Issue of loans
|
2,968
|
500
|
Repayment of loans
|
(1,609)
|
(1,500)
|
Dividends paid
|
(3,572)
|
(3,592)
|
Hedge contracts relating to dividend payments
|
(101)
|
4
|
Repayment of obligations under leases
|
(207)
|
(186)
|
Movement in short-term borrowings
|
288
|
(516)
|
|
|
|
Net cash outflow from financing activities
|
(2,203)
|
(1,765)
|
|
|
|
Net increase in cash and cash equivalents in the
period
|
2,311
|
547
|
Cash and cash equivalents at the beginning of the
period
|
5,223
|
4,671
|
Exchange rate effects
|
12
|
5
|
|
|
|
Cash and cash equivalents at the end of the period
|
7,546
|
5,223
|
|
|
|
Cash and cash equivalents consist of:
|
|
|
Cash and cash equivalents
|
7,832
|
5,369
|
Overdrafts
|
(286)
|
(146)
|
|
|
|
|
7,546
|
5,223
|
Notes to the Condensed Financial Statements
1) Basis of preparation
and accounting policies
The Condensed Consolidated Financial Statements for the year ended
31 December 2020 have been prepared in accordance with
International Financial Reporting Standards (IFRSs) adopted
pursuant to Regulation (EC) No 1606/2002 as it applies in the EU
and as issued by the International Accounting Standards Board
(IASB). 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
will transition to UK-adopted international accounting standards
for financial periods beginning 1 January 2021.
These Condensed Consolidated Financial Statements comprise the
financial results of AstraZeneca PLC for the years to 31 December
2020 and 2019 together with the Statement of financial position as
at 31 December 2020 and 2019. The results for the year to 31
December 2020 have been extracted from the 31 December 2020 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 15
February 2021 within the Annual Report and Form 20-F Information
2020.
The financial information set out above does not constitute the
Group's statutory accounts for the years to 31 December 2020 or
2019 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 2020 or 31 December 2019. Statutory accounts for the
year to 31 December 2020 were approved by the Board of Directors
for release on 11 February 2021.
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
2019.
IFRS 3
An amendment to IFRS 3 'Business Combinations' relating to the
definition of a business was endorsed by the EU in April 2020, with
an effective date of 1 January 2020. The change in definition of a
business within IFRS 3 introduces an optional concentration test to
perform a simplified assessment of whether an acquired set of
activities and assets is or is not a business on a
transaction-by-transaction basis. This change is expected to result
in more consistency in accounting in the pharmaceutical industry
for substantially similar transactions for which, under the
previous definition, may have been accounted in different ways,
despite limited differences in substance. The Group has adopted
this amendment from the effective date.
IFRS 9, IAS 39 and IFRS 7
The replacement of benchmark interest rates, such as the London
Inter-bank Offered Rate (LIBOR) and other interbank offered rates
(IBORs) is a priority for global regulators and is expected to be
largely completed in 2021. To prepare for this, the Group early
adopted the Phase 1 amendments to IFRS 9 'Financial Instruments'
and IFRS 7 'Financial Instruments: Disclosures' in 2019. These
amendments provide relief from applying specific hedge accounting
requirements to hedge relationships directly affected by IBOR
reform and have the effect that the reform should generally not
cause hedge accounting to terminate. There was no financial impact
from the early adoption of these amendments. Further amendments
(Phase 2) were issued on 27 August 2020 and the Group will apply
these in 2021.
The Group has one IFRS 9 designated hedge relationship that is
impacted by IBOR reform, namely a €300m cross currency
interest rate swap in a fair value hedge relationship with
€300m of a €750m 0.875% 2021 non-callable bond. This
swap references three-month USD LIBOR; uncertainty arising from the
Group's exposure to IBOR reform will cease when the swap matures in
2021. The implications on the wider business of IBOR reform have
been assessed and the Group is currently preparing to move to the
new benchmark rates in 2021.
Government grants
Government grants are recognised in the Consolidated statement of
comprehensive income so as to match with the related expenses that
they are intended to compensate. Where grants are received in
advance of the related expenses, they are initially recognised in
the Consolidated statement of financial position under Trade and
other payables as deferred income and released to net off against
the related expenditure when incurred. Each contract is assessed to
determine whether there are both grant elements and supply of
product which need to be separated. In each case, contracts set out
the specified terms for the supply of the product and the
provisions for funding for certain costs, primarily research and
development associated with the IP. It is considered whether there
are any conditions for the funding to be refunded. The
consideration in the contract is allocated between the grant and
supply elements. The standalone selling price for the supply of
products is determined by reference to observed prices with other
customers. The amount allocated as a government grant is determined
by reference to the specific agreed costs and activities identified
in the contract as being related to activities not directly
attributable to the supply of product. Government grants are
recorded as an offset to the relevant expense in the Income
Statement and are capped to match the relevant costs
incurred.
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 2020 and the
financial position as at 31 December 2020, specifically considering
the impact on key judgements and significant estimates as detailed
on page 173 of the Annual Report and 20-F
Information 2019 along
with a several other areas of increased risk.
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
2020.
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 2020, the Group had $12.1bn in financial resources (cash
and cash-equivalent balances of $7.8bn, $0.2bn of liquid fixed
income securities and undrawn committed bank facilities of $4.1bn,
of which $3.4bn is available until April 2024, $0.7bn is available
until November 2021 (with a one-year extension option, exercisable
by the Group), with only $2.4bn of borrowings due within one year).
To support the financing of the acquisition of Alexion, the Group
entered into committed bank facilities totalling $17.5bn during
December 2020. The facilities are intended to cover the financing
of the cash portion of the acquisition consideration and associated
acquisition costs and to refinance the existing term loan and
revolving credit facilities of Alexion. All facilities contain no
financial covenants and were undrawn at 31 December
2020.
The directors have considered the impact of COVID-19 on
AstraZeneca's operations (including the effects of any governmental
or regulatory response to the pandemic), 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 Company 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 many of the
mature 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 5 updates the disclosures
concerning legal proceedings and contingent liabilities in the
Group's Annual Report and Form
20-F Information 2019.
Financial information
The comparative figures for the financial year ended 31 December
2019 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. This resulted in a total net impairment charge of $240m
being recorded against intangible assets during the year ended 31
December 2020 (2019: $1,033m).
Impairment charges in respect of launched products totalled $350m
(2019: $425m), including Duaklir ($200m, revised carrying amount of
$210m), Bydureon ($102m, revised carrying amount of $581m),
and other launched products totalling $48m. If revenue projections
for Bydureon were to fall by 15% over the forecast
period, this would result in a further impairment charge of
c.$110m. Impairment charges recorded against products in
development totalled $55m (2019: $609m).
The impairments recorded on launched products were a consequence of
revised market volume, share and price assumptions. Impairments
recorded on products in development were a consequence of failed or
poor performing trials, with the individual assets being fully
impaired.
The Group has performed an assessment on assets which have had
impairments recorded in previous periods to determine if any
reversals of impairments were required. Impairment reversals of
$165m were recorded in 2020 in respect of launched products (2019:
$3m in respect of products in development),
including FluMist ($147m, revised carrying amount of $300m,
driven by expanded vaccination efforts increasing global demand),
and other launched products of $18m.
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 2019. Net Debt
is a non-GAAP financial measure.
Table 43: Net
Debt
|
At
1 Jan 2020
|
Cash flow
|
Non-cash & other
|
Exchange movements
|
At
31 Dec 2020
|
$m
|
$m
|
$m
|
$m
|
$m
|
Non-current instalments of loans
|
(15,730)
|
(2,968)
|
1,394
|
(201)
|
(17,505)
|
Non-current instalments of leases
|
(487)
|
-
|
11
|
(13)
|
(489)
|
|
|
|
|
|
|
Total long-term debt
|
(16,217)
|
(2,968)
|
1,405
|
(214)
|
(17,994)
|
|
|
|
|
|
|
Current instalments of loans
|
(1,597)
|
1,609
|
(1,411)
|
(137)
|
(1,536)
|
Current instalments of leases
|
(188)
|
226
|
(225)
|
(5)
|
(192)
|
Bank collateral
|
(71)
|
(217)
|
-
|
-
|
(288)
|
Other short-term borrowings excluding overdrafts
|
(8)
|
(71)
|
-
|
(5)
|
(84)
|
Overdraft
|
(146)
|
(138)
|
-
|
(2)
|
(286)
|
|
|
|
|
|
|
Total current debt
|
(2,010)
|
1,409
|
(1,636)
|
(149)
|
(2,386)
|
|
|
|
|
|
|
Gross borrowings
|
(18,227)
|
(1,559)
|
(231)
|
(363)
|
(20,380)
|
|
|
|
|
|
|
Net derivative financial instruments
|
43
|
101
|
134
|
-
|
278
|
|
|
|
|
|
|
Net borrowings
|
(18,184)
|
(1,458)
|
(97)
|
(363)
|
(20,102)
|
|
|
|
|
|
|
Cash and cash equivalents
|
5,369
|
2,449
|
-
|
14
|
7,832
|
Other investments - current
|
849
|
(745)
|
61
|
(5)
|
160
|
Other investments - non-current
|
62
|
-
|
(62)
|
-
|
-
|
Cash and investments
|
6,280
|
1,704
|
(1)
|
9
|
7,992
|
|
|
|
|
|
|
Net Debt
|
(11,904)
|
246
|
(98)
|
(354)
|
(12,110)
|
Non-cash movements in the period include fair-value adjustments
under IFRS 9.
Other investments - non-current are included within the balance of
$1,108m (31 December 2019: $1,401m) 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 put-option liability of $2,297m (31 December 2019: $2,146m),
shown in non-current other payables.
Net Debt increased by $206m in the year to $12,110m. Details of the
committed undrawn bank facilities are disclosed within the
going-concern section of Note 1.
During the year to 31 December 2020, there were no changes to the
Company's credit ratings issued by Standard and Poor's (long term:
BBB+, short term A-2) and Moody's (long term: A3, short term
P-2).
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, leases and
interest-bearing loans and borrowings. During the period, equity
investments previously categorised as Level 3 in the fair-value
hierarchy (carrying value of $103m at 31 December 2019) are now
categorised as Level 1 (carrying value of $128m at 31 December
2020) on availability of quoted prices in an active 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 2019.
The Group holds certain equity investments that are categorised as
Level 3 in the fair-value hierarchy and for which fair-value gains
of $63m have been recognised in the year ended 31 December 2020.
All other fair-value gains and/or losses that are presented in Net
gains/(losses) on equity investments measured at fair value through
other comprehensive income in the Condensed consolidated statement
of comprehensive income for the year ended 31 December 2020 are
Level 1 fair-value measurements.
Financial instruments measured at fair value include $1,268m of
other investments, $6,602m held in money-market funds, $339m of
loans designated at fair value through profit or loss, $371m of
loans designated in a fair-value hedge relationship and $278m of
derivatives as at 31 December 2020. The total fair value of
interest-bearing loans and borrowings at 31 December 2020, which
have a carrying value of $20,380m in the Condensed consolidated
statement of financial position, was $23,825m.
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 44: Financial instruments -
contingent consideration
|
2020
|
2019
|
Diabetes alliance
|
Other
|
Total
|
Total
|
$m
|
$m
|
$m
|
$m
|
At 1 January
|
3,300
|
839
|
4,139
|
5,106
|
Settlements
|
(546)
|
(276)
|
(822)
|
(709)
|
Revaluations
|
(51)
|
(221)
|
(272)
|
(614)
|
Discount unwind
|
229
|
49
|
278
|
356
|
|
|
|
|
|
At 31 December
|
2,932
|
391
|
3,323
|
4,139
|
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 $2,932m (31 December 2019: $3,300m)
would increase/decline by $293m with an increase/decline in sales
of 10%, as compared with the current estimates.
5) 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 2019, H1 2020 and
Q3 2020 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.
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 2020 and to
11 February 2021
Patent litigation
Enhertu
US patent proceedings
As previously disclosed, in October 2020, Seagen Inc. (Seagen)
filed a complaint against Daiichi Sankyo in the US District Court
for the Eastern District of Texas alleging
that Enhertu infringes US Patent No 10,808,039 (the '039
patent). AstraZeneca Pharmaceuticals LP
co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. A claim
construction hearing has been scheduled for August 2021 and a trial
has been scheduled for April 2022.
In November 2020, AstraZeneca, Daiichi Sankyo and Daiichi Sankyo
Inc. filed a complaint against Seagen in the US District Court for
the District of Delaware seeking a declaratory judgment that
plaintiffs do not infringe the '039 patent. On 18 December 2020,
Seagen filed a motion seeking to stay or dismiss this
action.
On 23 December 2020, AstraZeneca and Daiichi Sankyo Inc. filed a
post grant review petition with the US Patent and Trademark Office
alleging, inter alia, that the '039 patent is invalid for lack of
written description and entablement. In January 2021, AstraZeneca
and Daiichi Sankyo, Inc. filed a second post grant review petition
with the US Patent and Trademark Office extending its challenge to
additional claims in the '039 patent. A decision on institution of
these petitions is expected in July 2021.
Symbicort
US patent proceedings
As previously disclosed, AstraZeneca has Abbreviated New Drug
Application litigation pending against Mylan Pharmaceuticals Inc.
and Kindeva Drug Delivery L.P. in the US District Court for the
Northern District of West Virginia. The trial of the matter was
held in October 2020 and closing argument was held on 12 January
2021. A decision is awaited.
Movantik
US patent proceedings
As previously disclosed, in March 2020, Aether Therapeutics, Inc.
filed a patent infringement lawsuit in the US District Court for
the District of Delaware against AstraZeneca, Nektar Therapeutics
and Daiichi Sankyo, Inc., relating to Movantik. A trial has been set for March
2023.
Forxiga
Patent Proceedings outside the US
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 is considering its
response.
Product liability litigation
Farxiga and Xigduo XR
As previously disclosed, in several jurisdictions in the US,
AstraZeneca has been named as a defendant in lawsuits involving
plaintiffs claiming physical injury, including diabetic
ketoacidosis and kidney failure, from treatment
with Farxiga and/or Xigduo XR. In April 2017, the Judicial Panel on
Multidistrict Litigation ordered transfer of any currently pending
cases as well as of any similar, subsequently filed cases to a
co-ordinated and consolidated pre-trial multidistrict litigation
proceeding in the US District Court for the Southern District of
New York. All of these claims have been resolved or dismissed, and
the multidistrict litigation has been administratively
closed.
In addition, 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.
Bydureon/Byetta
As previously disclosed in the US, Amylin Pharmaceuticals, LLC, a
wholly owned subsidiary of AstraZeneca, and/or AstraZeneca are
among multiple defendants in various lawsuits filed in federal and
state courts involving claims of physical injury from treatment
with Bydureon and/or Byetta. The lawsuits allege several types of injuries
including pancreatitis, pancreatic cancer, thyroid cancer, and
kidney cancer. A multidistrict litigation was established in the US
District Court for the Southern District of California (the
District Court) in regard to the alleged pancreatic cancer cases in
federal courts. Further, a coordinated proceeding has been
established in Los Angeles (the California Court), California in
regard to the various lawsuits in California state courts. In
November 2015, the District Court granted the defendants' motion
for summary judgment and dismissed all claims alleging pancreatic
cancer that accrued prior to 11 September 2015. In November 2017,
the US Court of Appeals for the Ninth Circuit vacated the District
Court's order and remanded for further discovery. In November 2018,
the Court of Appeal for the State of California annulled the
judgment from the California state coordinated proceeding and
remanded for further discovery. In October and December 2020, the
District Court and the California Court jointly heard oral argument
on a renewed motion filed by Defendants seeking summary judgment
and dismissal of all claims. That motion remains
pending.
Commercial litigation
Amplimmune
As previously disclosed, in June 2017, AstraZeneca was served with
a lawsuit filed by the stockholders' agents for Amplimmune, Inc.
(Amplimmune) in Delaware State Court that alleged, among other
things, breaches of contractual obligations relating to a 2013
merger agreement between AstraZeneca and Amplimmune. In November
2020, the Court decided in AstraZeneca's favour and subsequently
entered a Final Judgment as to all pending claims in favour of
AstraZeneca. In December 2020, the plaintiffs filed an appeal to
the Delaware Supreme Court.
Definiens
As previously disclosed, in July 2020, AstraZeneca received a
notice of arbitration filed with the German Institution of
Arbitration from the sellers of Definiens AG (Sellers) regarding
the 2014 Share Purchase Agreement (SPA) between AstraZeneca and the
Sellers. The Sellers claim they are owed c.$140m in earn-outs under
the SPA; AstraZeneca disputes the claims of the Sellers. The
arbitration tribunal has scheduled an oral hearing in July
2022.
AZD1222 Securities Litigation
In January 2021, putative securities class action lawsuits were
filed in the US District Court for the Southern District of New
York against AstraZeneca PLC and certain officers, on behalf of
purchasers of AstraZeneca publicly traded securities during the
period 21 May 2020 through 20 November 2020. The complaints allege
that defendants made materially false and misleading statements in
connection with the development of AZD1222 (otherwise known
as C19VAZ), a potential recombinant adenovirus vaccine for
the prevention of COVID-19, and assert claims under sections
10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule
10b-5.
Government investigations/proceedings
Toprol-XL
Louisiana Attorney General Litigation
As previously disclosed, in July 2020, the Louisiana First Circuit
Court of Appeals (the Appellate Court) reversed and remanded a
Louisiana state trial court (the Trial Court) ruling that had
granted AstraZeneca's motion for summary judgment and dismissed a
state court complaint, brought by the Attorney General for the
State of Louisiana, alleging that AstraZeneca engaged in unlawful
monopolisation and unfair trade practices in connection with the
enforcement of its Toprol-XL patents. In August 2020, AstraZeneca
petitioned the Louisiana Supreme Court (the Supreme Court) to
review the decision of the Appellate Court and reinstate the Trial
Court's summary judgment ruling. In December 2020, the Supreme
Court granted AstraZeneca's petition and agreed to review the
Appellate Court's decision. AstraZeneca filed its opening appellate
brief with the Supreme Court in January 2021. A decision on the
merits of the appeal remains pending.
Crestor
Qui tam litigation
In the US, in January and February 2014, AstraZeneca was served
with lawsuits filed in the US District Court for the District of
Delaware under the qui tam provisions of the federal False Claims
Act and related state statutes, alleging that AstraZeneca directed
certain employees to promote Crestor off-label and provided unlawful remuneration
to physicians in connection with the promotion
of Crestor. The Department of Justice and all US states
declined to intervene in the lawsuits. In March 2019, AstraZeneca
filed a motion to dismiss the complaint. In February 2020, the
District Court partially granted AstraZeneca's motion to dismiss.
This matter was resolved and is now concluded.
US 340B Litigations and Proceedings
AstraZeneca is involved in several matters relating to its policy
with regard to contract pharmacy recognition
under the 340B Drug Pricing Program in the United States. In
October and November 2020, two lawsuits, one in the US District
Court for the District of Columbia and one in the US District Court
for the Northern District of California, 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 by an unlimited number of
contract pharmacies. AstraZeneca has sought to intervene in the
lawsuits. Administrative Dispute Resolution proceedings have
also been initiated against AstraZeneca before the US Health
Resources and Services Administration. In addition, in January 2021
AstraZeneca filed a separate lawsuit in federal court in Delaware
alleging that a recent Advisory Opinion issued by the Department of
Health and Human Services violates the Administrative Procedure
Act.
Taxation
As previously disclosed in the Annual Report and Form
20-F Information 2019,
AstraZeneca faces a number of audits and reviews in jurisdictions
around the world and, in some cases, is in dispute with the tax
authorities. The issues under discussion are often complex and can
require many years to resolve. Accruals for tax contingencies
require management to make key judgements and significant estimates
with respect to the ultimate outcome of current and potential
future tax audits, and actual results could vary from these
estimates. The total net accrual to cover the worldwide tax
exposure for transfer pricing and other international tax
contingencies of $287m (31 December 2019: $140m) reflected the
progress in those tax audits and reviews during the year and for
those audits where AstraZeneca and tax authorities are in dispute,
AstraZeneca estimates the potential for reasonably possible
additional liabilities above and beyond the amount provided to be
up to $251m, including associated interest (31 December 2019:
$76m). The total net accrual to cover the worldwide tax exposure
for other tax contingencies of $727m (31 December 2019:
$887m) reflected the progress in those tax audits and reviews
during the year and expiry of statute of limitations. AstraZeneca
estimates the potential for reasonably possible additional
liabilities above and beyond the amount provided to be up to $517m,
including associated interest (31 December 2019: $327m). The
Company believes that it is unlikely that these additional
liabilities will arise. It is possible that some of these
contingencies may reduce in the future to the extent that any tax
authority challenge is concluded, or matters lapse following expiry
of the relevant statutes of limitation resulting in a reduction in
the tax charge in future periods.
6) Subsequent
Events
In December 2020, AstraZeneca and Alexion announced that they had
entered into a definitive agreement for AstraZeneca to acquire
Alexion for a total consideration of $39bn, partly funded in cash
and partly in AstraZeneca American Depository Shares. The boards of
directors of both companies have unanimously approved the
acquisition. Subject to receipt of regulatory clearances and
approval by shareholders of both companies, the acquisition is
expected to close in the third quarter of 2021, and upon
completion, Alexion shareholders will own c.15% of the combined
company. In conjunction with the acquisition, AstraZeneca has
entered into committed bank facilities of $17.5bn.
In February 2021, AstraZeneca agreed to divest, subject to certain
limited exceptions, its 26.7% ownership in Viela Bio, Inc. (Viela),
as part of the proposed acquisition of Viela by Horizon
Therapeutics plc. AstraZeneca anticipates receiving cash proceeds
and profit of c.$760-780m upon closing for the sale of the holding,
which will be recorded in Reported and Core Other Operating Income
and Expense in the Company's financial statements. The divestment
is expected to complete by the end of the first quarter of
2021.
In February 2021, AstraZeneca completed its sale of rights
to Crestor and associated medicines in certain European
countries to Grünenthal for an upfront payment of $320m, which
will be recorded within Other operating income and expense. At 31
December 2020, there were no intangible or other assets on the
balance sheet relating to the disposal.
7)
|
Table 45:
Product Sales year-on-year analysis - FY 2020[97]
|
The CER information in respect of FY 2020 included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
4,328
|
36
|
36
|
1,208
|
59
|
63
|
1,566
|
24
|
748
|
58
|
56
|
806
|
18
|
16
|
Imfinzi
|
2,042
|
39
|
39
|
158
|
n/m
|
n/m
|
1,185
|
14
|
370
|
n/m
|
n/m
|
329
|
51
|
49
|
Lynparza
|
1,776
|
48
|
49
|
264
|
98
|
n/m
|
876
|
40
|
435
|
52
|
51
|
201
|
32
|
32
|
Calquence
|
522
|
n/m
|
n/m
|
6
|
n/m
|
n/m
|
511
|
n/m
|
2
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
Koselugo
|
38
|
n/m
|
n/m
|
-
|
-
|
-
|
38
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex*
|
888
|
9
|
13
|
561
|
14
|
20
|
5
|
(22)
|
140
|
4
|
4
|
182
|
1
|
1
|
Faslodex*
|
580
|
(35)
|
(34)
|
180
|
(9)
|
(4)
|
55
|
(83)
|
221
|
(3)
|
(3)
|
124
|
(10)
|
(11)
|
Iressa*
|
268
|
(37)
|
(36)
|
221
|
(23)
|
(22)
|
14
|
(21)
|
12
|
(82)
|
(82)
|
21
|
(57)
|
(57)
|
Arimidex*
|
185
|
(18)
|
(16)
|
147
|
(3)
|
1
|
-
|
-
|
3
|
(88)
|
(88)
|
35
|
(23)
|
(24)
|
Casodex*
|
172
|
(14)
|
(14)
|
133
|
4
|
6
|
-
|
-
|
3
|
(83)
|
(83)
|
36
|
(37)
|
(38)
|
Others
|
51
|
(47)
|
(46)
|
28
|
(1)
|
1
|
-
|
-
|
4
|
(41)
|
(40)
|
19
|
(69)
|
(69)
|
Total Oncology
|
10,850
|
25
|
26
|
2,906
|
31
|
36
|
4,250
|
23
|
1,938
|
36
|
35
|
1,756
|
11
|
10
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
1,959
|
27
|
30
|
686
|
46
|
55
|
569
|
6
|
507
|
36
|
35
|
197
|
21
|
21
|
Brilinta
|
1,593
|
1
|
2
|
461
|
-
|
4
|
732
|
3
|
342
|
(3)
|
(3)
|
58
|
-
|
2
|
Onglyza
|
470
|
(11)
|
(10)
|
201
|
14
|
18
|
166
|
(28)
|
58
|
(16)
|
(17)
|
45
|
(12)
|
(11)
|
Bydureon
|
448
|
(18)
|
(18)
|
4
|
(62)
|
(59)
|
382
|
(17)
|
53
|
(20)
|
(20)
|
9
|
(32)
|
(31)
|
Byetta
|
68
|
(37)
|
(36)
|
8
|
(35)
|
(23)
|
37
|
(45)
|
14
|
(24)
|
(24)
|
9
|
(18)
|
(17)
|
Other diabetes
|
47
|
(10)
|
(10)
|
7
|
n/m
|
n/m
|
25
|
(37)
|
13
|
38
|
38
|
2
|
26
|
28
|
Lokelma
|
76
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
57
|
n/m
|
4
|
n/m
|
n/m
|
10
|
n/m
|
n/m
|
Crestor*
|
1,180
|
(8)
|
(7)
|
748
|
(7)
|
(5)
|
92
|
(11)
|
129
|
(13)
|
(15)
|
211
|
(4)
|
(5)
|
Seloken/Toprol-XL*
|
821
|
8
|
12
|
782
|
14
|
18
|
13
|
(66)
|
16
|
(35)
|
(35)
|
10
|
(11)
|
(10)
|
Atacand*
|
243
|
10
|
15
|
175
|
9
|
17
|
10
|
(12)
|
35
|
17
|
17
|
23
|
15
|
15
|
Others
|
191
|
(30)
|
(30)
|
126
|
(35)
|
(34)
|
-
|
n/m
|
57
|
(5)
|
(4)
|
8
|
(60)
|
(61)
|
BioPharmaceuticals: total CVRM
|
7,096
|
3
|
5
|
3,203
|
8
|
12
|
2,083
|
(6)
|
1,228
|
7
|
6
|
582
|
2
|
2
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
2,721
|
9
|
10
|
567
|
4
|
9
|
1,022
|
23
|
694
|
2
|
2
|
438
|
(1)
|
-
|
Pulmicort
|
996
|
(32)
|
(32)
|
798
|
(33)
|
(33)
|
71
|
(35)
|
73
|
(10)
|
(10)
|
54
|
(37)
|
(37)
|
Fasenra
|
949
|
35
|
34
|
12
|
n/m
|
n/m
|
603
|
25
|
203
|
72
|
70
|
131
|
33
|
32
|
Daliresp/Daxas
|
217
|
1
|
1
|
4
|
(9)
|
(8)
|
190
|
3
|
22
|
(14)
|
(13)
|
1
|
(10)
|
(8)
|
Bevespi
|
48
|
16
|
15
|
1
|
n/m
|
n/m
|
44
|
7
|
3
|
n/m
|
n/m
|
-
|
-
|
-
|
Breztri
|
28
|
n/m
|
n/m
|
14
|
n/m
|
n/m
|
5
|
n/m
|
-
|
-
|
-
|
9
|
n/m
|
n/m
|
Others
|
398
|
(15)
|
(15)
|
203
|
(15)
|
(16)
|
6
|
(12)
|
176
|
(14)
|
(15)
|
13
|
(15)
|
(7)
|
BioPharmaceuticals: total Respiratory & Immunology
|
5,357
|
(1)
|
-
|
1,599
|
(20)
|
(18)
|
1,941
|
17
|
1,171
|
6
|
5
|
646
|
-
|
1
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium*
|
1,492
|
1
|
2
|
757
|
1
|
4
|
169
|
(22)
|
71
|
12
|
10
|
495
|
9
|
8
|
Synagis*
|
372
|
4
|
4
|
-
|
-
|
-
|
47
|
2
|
325
|
4
|
4
|
-
|
-
|
-
|
FluMist*
|
295
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
70
|
n/m
|
219
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
Losec/Prilosec*
|
183
|
(30)
|
(30)
|
152
|
(15)
|
(14)
|
6
|
(44)
|
20
|
(59)
|
(59)
|
5
|
(78)
|
(79)
|
Seroquel XR/IR*
|
117
|
(39)
|
(37)
|
55
|
11
|
14
|
17
|
(48)
|
29
|
(67)
|
(67)
|
16
|
(19)
|
(18)
|
Others
|
128
|
(33)
|
(34)
|
6
|
(51)
|
(44)
|
55
|
(50)
|
58
|
(7)
|
(8)
|
9
|
6
|
(5)
|
Total other medicines
|
2,587
|
(1)
|
-
|
971
|
(2)
|
1
|
364
|
(17)
|
722
|
8
|
7
|
530
|
5
|
3
|
Total Product Sales
|
25,890
|
10
|
11
|
8,679
|
6
|
10
|
8,638
|
12
|
5,059
|
16
|
15
|
3,514
|
6
|
6
|
8)
|
Table 46:
Product Sales year-on-year analysis - Q4 2020[98]
|
The Q4 2020 information in respect of the three months ended 31
December 2020 included in the Consolidated Financial Information
has not been audited by PricewaterhouseCoopers LLP.
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
1,157
|
31
|
28
|
258
|
23
|
23
|
422
|
18
|
245
|
80
|
69
|
232
|
29
|
25
|
Imfinzi
|
555
|
31
|
29
|
45
|
n/m
|
n/m
|
300
|
6
|
115
|
78
|
68
|
95
|
44
|
41
|
Lynparza
|
496
|
42
|
40
|
69
|
n/m
|
n/m
|
245
|
27
|
124
|
58
|
49
|
58
|
29
|
27
|
Calquence
|
182
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
176
|
n/m
|
2
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
Koselugo
|
17
|
n/m
|
n/m
|
-
|
-
|
-
|
17
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex*
|
216
|
11
|
13
|
134
|
20
|
27
|
(1)
|
n/m
|
36
|
2
|
(3)
|
47
|
-
|
(4)
|
Faslodex*
|
130
|
(21)
|
(22)
|
39
|
(27)
|
(22)
|
10
|
(40)
|
50
|
(17)
|
(22)
|
31
|
(12)
|
(14)
|
Iressa*
|
67
|
(16)
|
(19)
|
58
|
(2)
|
(6)
|
3
|
(7)
|
1
|
(88)
|
(89)
|
5
|
(41)
|
(43)
|
Arimidex*
|
36
|
(29)
|
(30)
|
26
|
(22)
|
(23)
|
-
|
-
|
1
|
(87)
|
(88)
|
9
|
(9)
|
(13)
|
Casodex*
|
39
|
(10)
|
(13)
|
29
|
3
|
(1)
|
-
|
-
|
1
|
(80)
|
(80)
|
9
|
(16)
|
(22)
|
Others
|
13
|
(53)
|
(52)
|
8
|
25
|
19
|
-
|
-
|
-
|
(86)
|
(87)
|
5
|
(74)
|
(74)
|
Total Oncology
|
2,908
|
28
|
26
|
668
|
22
|
24
|
1,172
|
29
|
575
|
45
|
37
|
493
|
17
|
14
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
586
|
40
|
40
|
198
|
50
|
57
|
184
|
31
|
144
|
45
|
36
|
60
|
27
|
24
|
Brilinta
|
363
|
(15)
|
(15)
|
69
|
(39)
|
(36)
|
195
|
(7)
|
85
|
(5)
|
(10)
|
14
|
(6)
|
(7)
|
Onglyza
|
105
|
(20)
|
(21)
|
47
|
3
|
4
|
32
|
(44)
|
15
|
(6)
|
(12)
|
11
|
(18)
|
(16)
|
Bydureon
|
122
|
(12)
|
(12)
|
1
|
(26)
|
(18)
|
105
|
(12)
|
14
|
(7)
|
(11)
|
2
|
(42)
|
(49)
|
Byetta
|
19
|
(31)
|
(30)
|
-
|
n/m
|
(85)
|
13
|
(18)
|
4
|
(16)
|
(21)
|
2
|
(15)
|
(18)
|
Other diabetes
|
12
|
(23)
|
(22)
|
2
|
n/m
|
n/m
|
6
|
(53)
|
4
|
45
|
38
|
-
|
(43)
|
6
|
Lokelma
|
28
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
20
|
n/m
|
2
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
Crestor*
|
298
|
1
|
(1)
|
189
|
2
|
1
|
21
|
33
|
34
|
(7)
|
(13)
|
54
|
(8)
|
(11)
|
Seloken/Toprol-XL*
|
200
|
6
|
7
|
190
|
10
|
11
|
3
|
(52)
|
4
|
(32)
|
(32)
|
3
|
(7)
|
(18)
|
Atacand*
|
63
|
5
|
9
|
42
|
(2)
|
4
|
3
|
(16)
|
13
|
63
|
63
|
5
|
(7)
|
(15)
|
Others
|
46
|
(38)
|
(40)
|
33
|
(40)
|
(43)
|
-
|
n/m
|
12
|
(14)
|
(12)
|
1
|
(73)
|
(79)
|
BioPharmaceuticals: total CVRM
|
1,842
|
3
|
3
|
772
|
3
|
5
|
582
|
(1)
|
331
|
13
|
7
|
157
|
3
|
-
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
680
|
(5)
|
(5)
|
145
|
(1)
|
3
|
267
|
9
|
173
|
1
|
(4)
|
95
|
(37)
|
(38)
|
Pulmicort
|
368
|
(11)
|
(14)
|
319
|
(8)
|
(11)
|
18
|
(14)
|
18
|
(17)
|
(20)
|
13
|
(49)
|
(50)
|
Fasenra
|
283
|
38
|
35
|
2
|
24
|
37
|
180
|
30
|
63
|
72
|
61
|
38
|
31
|
27
|
Daliresp/Daxas
|
54
|
(6)
|
(7)
|
1
|
-
|
(6)
|
49
|
(3)
|
4
|
(35)
|
(37)
|
-
|
-
|
-
|
Bevespi
|
12
|
8
|
4
|
-
|
-
|
-
|
11
|
(5)
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
Breztri
|
6
|
n/m
|
n/m
|
(1)
|
n/m
|
n/m
|
2
|
n/m
|
-
|
-
|
-
|
5
|
n/m
|
n/m
|
Others
|
125
|
(8)
|
(12)
|
81
|
10
|
4
|
(2)
|
n/m
|
44
|
(19)
|
(24)
|
2
|
(48)
|
(20)
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,528
|
(1)
|
(2)
|
547
|
(4)
|
(5)
|
525
|
12
|
303
|
5
|
(1)
|
153
|
(27)
|
(28)
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium*
|
377
|
7
|
6
|
193
|
11
|
11
|
42
|
(2)
|
12
|
(18)
|
(25)
|
130
|
6
|
3
|
Synagis*
|
78
|
24
|
24
|
-
|
-
|
-
|
-
|
n/m
|
78
|
46
|
47
|
-
|
-
|
-
|
FluMist*
|
179
|
92
|
85
|
1
|
n/m
|
n/m
|
5
|
n/m
|
170
|
83
|
76
|
3
|
n/m
|
n/m
|
Losec/Prilosec*
|
39
|
(15)
|
(18)
|
33
|
(2)
|
(6)
|
2
|
(26)
|
4
|
(16)
|
(12)
|
-
|
(96)
|
(95)
|
Seroquel XR/IR*
|
19
|
(53)
|
(49)
|
15
|
68
|
77
|
(5)
|
n/m
|
7
|
(65)
|
(63)
|
2
|
(58)
|
(55)
|
Others
|
41
|
(30)
|
(31)
|
-
|
n/m
|
(90)
|
17
|
(42)
|
20
|
15
|
9
|
4
|
12
|
(17)
|
Total other medicines
|
733
|
12
|
10
|
242
|
8
|
8
|
61
|
(33)
|
291
|
43
|
39
|
139
|
3
|
-
|
Total Product Sales
|
7,011
|
12
|
11
|
2,229
|
7
|
7
|
2,340
|
14
|
1,500
|
27
|
21
|
942
|
2
|
-
|
9)
|
Table 47:
Product Sales quarterly sequential analysis - FY 2020[99]
|
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
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
Total Oncology
|
2,502
|
10
|
10
|
2,609
|
4
|
6
|
2,831
|
8
|
6
|
2,908
|
3
|
2
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
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: total CVRM
|
1,701
|
(5)
|
(5)
|
1,759
|
3
|
6
|
1,794
|
2
|
-
|
1,842
|
3
|
1
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
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/Daxas
|
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
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,551
|
1
|
1
|
1,117
|
(28)
|
(26)
|
1,161
|
4
|
1
|
1,528
|
32
|
29
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
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 other medicines
|
557
|
(15)
|
(15)
|
563
|
1
|
4
|
734
|
30
|
27
|
733
|
-
|
(2)
|
Total Product Sales
|
6,311
|
1
|
1
|
6,048
|
(4)
|
(2)
|
6,520
|
8
|
6
|
7,011
|
8
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10)
|
Table 48: Product Sales quarterly sequential analysis - FY
2019[100]
|
The sequential quarterly Product Sales information included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
|
Q1 2019
|
Q2 2019
|
Q3 2019
|
Q4 2019
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
630
|
6
|
6
|
784
|
24
|
25
|
891
|
14
|
13
|
884
|
(1)
|
-
|
Imfinzi
|
295
|
13
|
13
|
338
|
15
|
15
|
412
|
22
|
22
|
424
|
3
|
4
|
Lynparza
|
237
|
13
|
13
|
283
|
19
|
20
|
327
|
16
|
15
|
351
|
7
|
8
|
Calquence
|
29
|
21
|
23
|
35
|
21
|
19
|
44
|
27
|
27
|
56
|
25
|
25
|
Faslodex*
|
254
|
(6)
|
(6)
|
267
|
5
|
6
|
205
|
(23)
|
(23)
|
166
|
(20)
|
(19)
|
Zoladex*
|
194
|
7
|
6
|
197
|
2
|
1
|
226
|
15
|
16
|
196
|
(14)
|
(12)
|
Iressa*
|
134
|
20
|
18
|
118
|
(12)
|
(11)
|
91
|
(23)
|
(22)
|
80
|
(13)
|
(12)
|
Arimidex*
|
51
|
11
|
10
|
60
|
18
|
17
|
63
|
5
|
5
|
51
|
(20)
|
(18)
|
Casodex*
|
48
|
4
|
3
|
57
|
19
|
18
|
52
|
(8)
|
(6)
|
43
|
(18)
|
(17)
|
Others
|
20
|
(13)
|
(14)
|
28
|
40
|
29
|
20
|
(27)
|
(22)
|
26
|
30
|
26
|
Total Oncology
|
1,892
|
7
|
6
|
2,167
|
15
|
15
|
2,334
|
8
|
8
|
2,274
|
(3)
|
(2)
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
349
|
(12)
|
(12)
|
377
|
8
|
9
|
398
|
5
|
5
|
419
|
5
|
6
|
Brilinta
|
348
|
(7)
|
(8)
|
389
|
12
|
12
|
416
|
7
|
8
|
428
|
3
|
3
|
Onglyza
|
153
|
3
|
3
|
116
|
(24)
|
(24)
|
127
|
9
|
11
|
131
|
3
|
4
|
Bydureon
|
142
|
3
|
3
|
141
|
(1)
|
-
|
127
|
(10)
|
(10)
|
139
|
9
|
10
|
Byetta
|
30
|
(6)
|
(5)
|
25
|
(17)
|
(16)
|
28
|
10
|
13
|
27
|
(2)
|
(4)
|
Other diabetes
|
11
|
(8)
|
(17)
|
11
|
-
|
8
|
14
|
26
|
22
|
16
|
17
|
17
|
Lokelma*
|
-
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
8
|
87
|
74
|
Crestor*
|
335
|
(5)
|
(6)
|
310
|
(7)
|
(7)
|
337
|
9
|
9
|
296
|
(12)
|
(11)
|
Seloken/Toprol-XL*
|
225
|
41
|
38
|
168
|
(25)
|
(25)
|
177
|
6
|
8
|
190
|
7
|
8
|
Atacand*
|
50
|
(14)
|
(15)
|
56
|
12
|
14
|
55
|
(1)
|
(1)
|
60
|
8
|
9
|
Others
|
71
|
(3)
|
(5)
|
63
|
(11)
|
(8)
|
65
|
4
|
2
|
72
|
13
|
16
|
BioPharmaceuticals: total CVRM
|
1,714
|
(2)
|
(3)
|
1,658
|
(3)
|
(3)
|
1,749
|
5
|
6
|
1,785
|
2
|
3
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
585
|
(8)
|
(8)
|
585
|
-
|
1
|
613
|
5
|
4
|
712
|
16
|
17
|
Pulmicort
|
383
|
(2)
|
(2)
|
333
|
(13)
|
(13)
|
337
|
1
|
3
|
413
|
22
|
23
|
Fasenra
|
129
|
3
|
4
|
167
|
29
|
30
|
202
|
21
|
21
|
206
|
2
|
2
|
Daliresp/Daxas
|
48
|
(11)
|
(12)
|
56
|
17
|
18
|
53
|
(6)
|
(7)
|
58
|
10
|
10
|
Bevespi
|
10
|
-
|
(5)
|
10
|
-
|
2
|
10
|
4
|
8
|
12
|
8
|
5
|
Breztri
|
-
|
-
|
-
|
-
|
-
|
-
|
1
|
-
|
-
|
1
|
(74)
|
(73)
|
Others
|
128
|
(14)
|
(12)
|
101
|
(21)
|
(23)
|
102
|
1
|
(1)
|
135
|
33
|
38
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,283
|
(6)
|
(6)
|
1,252
|
(2)
|
(2)
|
1,319
|
5
|
6
|
1,537
|
17
|
17
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium*
|
363
|
(7)
|
(8)
|
393
|
8
|
8
|
374
|
(5)
|
(4)
|
353
|
(6)
|
(6)
|
Synagis*
|
53
|
(79)
|
(79)
|
96
|
81
|
81
|
146
|
52
|
53
|
63
|
(57)
|
(57)
|
Losec/Prilosec*
|
76
|
27
|
26
|
68
|
(11)
|
(10)
|
73
|
8
|
9
|
46
|
(38)
|
(38)
|
Seroquel XR/IR*
|
37
|
(34)
|
(33)
|
32
|
(14)
|
(10)
|
82
|
n/m
|
n/m
|
40
|
(50)
|
(49)
|
Others
|
47
|
(65)
|
(64)
|
52
|
11
|
11
|
56
|
8
|
-
|
151
|
n/m
|
n/m
|
Total other medicines
|
576
|
(35)
|
(36)
|
641
|
11
|
12
|
731
|
14
|
14
|
653
|
(11)
|
(10)
|
Total Product Sales
|
5,465
|
(5)
|
(6)
|
5,718
|
5
|
5
|
6,132
|
7
|
8
|
6,250
|
2
|
3
|
Table 49: Historic Collaboration
Revenue
|
|
FY 2020
|
FY 2019
|
FY 2018
|
$m
|
$m
|
$m
|
Initial Collaboration Revenue
|
Crestor (Spain)
|
-
|
-
|
61
|
Ongoing Collaboration Revenue
|
Lynparza: regulatory
milestones
|
160
|
60
|
140
|
Lynparza: sales
milestones
|
300
|
450
|
250
|
Lynparza/Koselugo: option payments
|
-
|
100
|
400
|
Crestor (Spain)
|
-
|
39
|
-
|
Enhertu: share of gross
profits
|
94
|
-
|
-
|
Roxadustat: share of gross profits
|
30
|
-
|
-
|
Royalty income
|
62
|
62
|
49
|
|
Other Collaboration Revenue
|
81
|
108
|
141
|
Total
|
727
|
819
|
1,041
|
Table 50: Other Operating Income and
Expense
The table below provides an analysis of Reported Other Operating
Income and Expense.
|
FY 2020
|
FY 2019
|
FY 2018
|
$m
|
$m
|
$m
|
Hypertension medicines (ex-US, India and Japan)
|
350
|
-
|
-
|
Monetisation of an asset
previously licensed
|
120
|
-
|
-
|
Brazikumab licence termination funding
|
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
|
-
|
728
|
Seroquel
|
-
|
-
|
527
|
Legal settlement
|
-
|
-
|
346
|
Atacand
|
400
|
-
|
210
|
Anaesthetics
|
-
|
-
|
172
|
Alvesco, Omnaris and Zetonna
|
-
|
-
|
139
|
Other
|
446
|
389
|
405
|
|
|
|
|
Total
|
1,528
|
1,541
|
2,527
|
Shareholder information
Announcement of
first quarter results
|
30
April 2021
|
Announcement of
half year and second quarter results
|
29 July
2021
|
Announcement of
year to date and third quarter results
|
12
November 2021
|
|
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 2020, payable
on 29 March 2021, will be 26 February 2021. The ex-dividend date
will be 25 February 2021.
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 Alvesco, Omnaris and Zetonna, trademarks of Covis
Pharma; Arimidex and Casodex, owned by AstraZeneca or Juvisé (depending
on geography); Atacand and Atacand
Plus, owned by AstraZeneca or
Cheplapharm (depending on geography); Duaklir, Eklira and Tudorza, 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 Arexis AB or AbbVie Inc. (depending on
geography); 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.
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
|
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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 failure to obtain, defend and enforce effective IP
protection and IP challenges by third parties
-
the impact of competitive pressures including expiry or loss of IP
rights, and generic competition
-
the impact of price controls and reductions
-
the impact of economic, regulatory and political
pressures
-
the impact of uncertainty and volatility in relation to the UK's
exit from the EU
-
the risk of failures or delays in the quality or execution of the
Group's commercial strategies
-
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, data protection or
cybercrime
-
the risk of failure of critical processes
-
any expected gains from productivity initiatives are
uncertain
-
the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce, including following the
Alexion transaction
-
the risk of failure to adhere to applicable laws, rules and
regulations
-
the risk of the safety and efficacy of marketed medicines being
questioned
-
the risk of adverse outcome of litigation and/or governmental
investigations, including relating to the Alexion
transaction
-
the risk of failure to adhere to increasingly stringent
anti-bribery and anti-corruption legislation
-
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
- the
risk that a condition to the
closing of the transaction with Alexion may not be satisfied, or
that a regulatory approval that may be required for the transaction
is delayed or is obtained subject to conditions that are not
anticipated
- the risk that
AstraZeneca is unable to achieve the synergies and value creation
contemplated by the Alexion transaction, or that AstraZeneca is
unable to promptly and effectively integrate Alexion's
businesses
- and the risk that
management's time and attention are diverted on transaction-related
issues or that disruption from the Alexion transaction makes it
more difficult to maintain business, contractual and operational
relationships
Nothing in this document, or any related presentation/webcast,
should be construed as a profit forecast.
Important additional information
In connection with the proposed transaction, the Group intends to
file a registration statement on Form F-4 with the US Securities
and Exchange Commission (SEC), which will include a document that
serves as a prospectus of the Group and a proxy statement of
Alexion (the proxy statement/prospectus), Alexion intends to file a
proxy statement with the SEC (the proxy statement) and each party
will file other documents regarding the proposed transaction with
the SEC. Investors and security holders of Alexion are urged to
carefully read the entire registration statement and proxy
statement/prospectus or proxy statement and other relevant
documents filed with the SEC when they become available, because
they will contain important information. A definitive proxy
statement/prospectus or a definitive proxy statement will be sent
to Alexion's shareholders. Investors and security holders will be
able to obtain the registration statement and the proxy
statement/prospectus or the proxy statement free of charge from the
SEC's website or from the Group or Alexion as described in the
paragraphs below.
The documents filed by the Group with the SEC may be obtained free
of charge at the SEC's website at www.sec.gov.
These documents may also be obtained free of charge on the Group's
website at http://www.astrazeneca.com under
the tab 'Investors'.
The documents filed by Alexion with the SEC may be obtained free of
charge at the SEC's website at www.sec.gov.
These documents may also be obtained free of charge on Alexion's
internet website at http://www.alexion.com under
the tab, 'Investors' and under the heading 'SEC Filings or by
contacting Alexion's Investor Relations Department
at investorrelations@alexion.com.
Participants in the solicitation
Alexion, the Group and certain of their directors, executive
officers and employees may be deemed participants in the
solicitation of proxies from Alexion shareholders in connection
with the proposed transaction. Information regarding the persons
who may, under the rules of the SEC, be deemed participants in
the solicitation of the shareholders of Alexion in connection with
the proposed transaction, including a description of their direct
or indirect interests, by security holdings or otherwise, will be
set forth in the proxy statement/prospectus or proxy statement when
it is filed with the SEC. Information about the directors and
executive officers of Alexion and their ownership of Alexion shares
is set forth in the definitive proxy statement for Alexion's 2020
special meeting of shareholders, as previously filed with the SEC
on 26 March 2020. Free copies of these documents may be
obtained as described in the paragraphs above.
- End of document -
[11] Adjuvant therapy is
used after surgery.
[12] Non-small cell lung
cancer.
[13] Epidermal growth
factor receptor mutation.
[14] Every four
weeks.
[15] The first treatment
given for a metastatic disease.
[16] Homologous
recombination deficiency positive.
[17] Breast cancer
susceptibility gene 1/2 mutation.
[18] Human epidermal
growth factor receptor 2 positive.
[19] Chronic lymphocytic
leukaemia, the most common type of leukaemia in
adults.
[20] Heart
failure.
[21] CV outcomes
trial.
[22] Chronic obstructive
pulmonary disease.
[23] Chronic kidney
disease.
[24] Systemic lupus
erythematosus, a chronic autoimmune disease that causes
inflammation in connective tissues throughout the
body.
[25] Tremelimumab.
[26] Relapsed/refractory.
[27] The tumour cannot be
removed completely through surgery.
[28] Overall
survival.
[29] Neurofibromatosis
type 1, a genetic condition causing tumours to grow
along nerves in the skin,
brain and other parts of the body.
[30] Coronary artery
disease.
[31] Type-2
diabetes.
[32] Benign soft growths
inside the nose.
[33] HER2
immunohistochemistry (IHC) 1 or 2 with fluorescence in situ
hybridisation (ISH) test-result .
[34] HF with preserved
ejection fraction.
[35] Extensive-stage small
cell lung cancer.
[36] Limited-stage small
cell lung cancer.
[37] Myelodysplastic
syndrome/.
[38] Respiratory syncytial
virus.
[39] A
prior diabetes
alliance between
AstraZeneca and Bristol-Myers Squibb Company (BMS). The Company
acquired the entirety of BMS's interests in the alliance in
2014.
[40] Over the
counter.
[41] Legacy
medicine.
[42] Substitution of
threonine (T) with methionine (M) at position 790 of exon 20
mutation.
[43] Sodium-glucose
co-transporter-2.
[44] Dipeptidyl peptidase
4.
[45] Here, excludes any
Collaboration Revenue associated with the aforementioned
collaboration with MSD.
[46] Core financial
measures are adjusted to exclude certain items. For more
information on the Reported to Core financial adjustments, please
refer to the introduction to the
operating and financial review.
[47] Where AstraZeneca
does not retain a significant ongoing interest in medicines or
potential new medicines, income from divestments is reported within
Other Operating Income and Expense in the Company's financial
statements.
[48] Based on best
prevailing assumptions around currency
profiles.
[49] Based on average
daily spot rates in FY 2020.
[50] Based on average
daily spot rates from 1 January 2021 to 31 January
2021.
[51] Other currencies
include AUD, BRL, CAD, KRW and RUB.
[52] 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'.
[53] Phase II/IIb trial
with potential for registration.
[54] First patient
commenced dosing.
[55] Last patient
commenced dosing.
[56] Programmed death-ligand
1.
[57] Standard of
Care.
[58] Conducted by the
Canadian Cancer Trials Group.
[59] Progression-free
survival.
[60] Bacillus
Calmette-Guerin.
[61] Hepatocellular
carcinoma.
[62] Transarterial
chemoembolisation.
[63] Head and neck
squamous cell carcinoma.
[64] The US Orphan Drug
Act grants special status to a medicine or potential medicine to
treat a rare disease or condition upon request of a manufacturer.
Designation qualifies the manufacturer of the medicine for various
development incentives.
[65] Conducted by the
ARCAGY/Groupe investigators national des Etudes des Cancers
Ovariens et du sein.
[66] Fluorouracil.
[67] IHC 3+ and IHC
2+/ISH+.
[68] Intended to expedite
the development and review of medicines for serious or
life-threatening conditions.
[69] Quaque die, or once a day.
[70] A process designed to
facilitate the development, and expedite the review of medicines to
treat serious conditions and fill an unmet medical
need.
[71] Independent Data
Monitoring Committee.
[72] Bis in die, or twice a day.
[73] Ischaemic strokes are
the most common type of stroke.
[74] Once every eight
weeks.
[75] Subcutaneous
injection.
[76] A
rare autoimmune condition that causes inflammation of small and
medium-sized blood vessels.
[77] Birmingham Vasculitis
Activity Score.
[78] Hypereosinophilic
syndrome, a group of rare blood
disorders.
[79] White blood cells
gather in the lining of the oesophagus.
[80] An improvement in the
view of tissue samples under a microscope after
treatment.
[81] Difficulty with
swallowing.
[82] Patient-reported
outcomes.
[83] Bullous pemphigoid, a
skin condition that causes large, itchy, fluid-filled
blisters.
[84] Conducted by the
University of Oxford.
[85] Conducted by
University of Witwatersrand, South Africa.
[86] Human
immunodeficiency virus-positive.
[87] Intramuscular.
[88] Conducted by the
NIH.
[89] The dates in the
table relating to anticipated data for the accelerated development
programme for C19VAZ refer to initial data, the timing of which
are uncertain and subject to change resulting from factors such as
changes in the level of community transmission. The timelines
provided represent the best, current estimate of when initial
efficacy data may be available.
[90] Sponsored by St.
Luke's Mid-America Heart Institute, Kansas City,
US.
[91] Conducted by
Cambridge University Hospitals NHS Trust.
[92] Conducted by
Direction de la Recherche Clinique et de l'Innovation L'Assistance
Publique - Hôpitaux de Paris (DRCI AP-HP).
[93] Sponsored by
Fundació Clinic per a la Recerca
Biomèdica.
[94] Sponsored by the UK
Government's Therapeutics Taskforce.
[95] The Q4 2020 and Q4
2019 information in respect of the three months ended 31 December
2020 and 31 December 2019 respectively included in the Condensed
Financial Statements has not been audited by PricewaterhouseCoopers
LLP.
[96] The non-controlling
interests reserve relating to the minority shareholders of Acerta
Pharma, totalling $1,401m, has been reclassified into Retained
earnings.
[97] 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.
*Denotes a legacy medicine.
[98] 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.
*Denotes a legacy medicine.
[99] 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. *Denotes a legacy medicine.
[100] 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. *Denotes a legacy
medicine.
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:
11 February
2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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