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 April 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZN: First quarter 2021 results
AstraZeneca PLC
30
April 2021 07:00 BST
First
quarter 2021 results
Robust performance supports continued investment for long-term
sustainable growth
AstraZeneca
delivered robust revenue growth of 15% (11% at CER1) in the quarter to
$7,320m; excluding the contribution from the pandemic COVID-19
vaccine, revenue growth increased by 11% (7% at CER) to $7,045m.
The overall results in the quarter further increased the
Company’s profitability and cash generation, while the
pipeline demonstrated encouraging progress; the Company reiterates
full-year 2021 guidance.
Pascal Soriot, Chief Executive Officer, commented:
"We delivered solid progress in
the first quarter of 2021 and continued to advance our portfolio of
life-changing medicines. Oncology grew 16% and New CVRM grew 15%.
New medicines contributed over half of revenue and all regions
delivered encouraging growth. This performance ensured another
quarter of strong revenue and earnings progression, continued
profitability, and cash-flow generation, despite the pandemic's
ongoing negative impact on the diagnosis and treatment of many
conditions. Given the performance in the first quarter, in line
with our expectations, we reiterate our full-year guidance. We
expect the impact of COVID to reduce and anticipate a performance
acceleration in the second half of 2021.
Further
significant pipeline advances were achieved as we continued to
invest for long-term sustainable growth, including the OlympiA
Phase III trial demonstrating Lynparza’s benefit for certain
forms of early breast cancer. This sustained pipeline progress and
accelerating business performance underlines our commitment to
patients and delivering our growth potential, which will be further
complemented by the proposed acquisition of Alexion."
Table 1: Q1 2021 - Financial summary
|
|
|
|
Actual
|
CER
|
|
|
|
$m
|
% change
|
% change
|
|
- Product Sales
|
|
7,257
|
15
|
11
|
|
- Collaboration Revenue
|
|
63
|
43
|
42
|
|
Total revenue
|
|
7,320
|
15
|
11
|
|
- Less pandemic COVID-19 vaccine
|
|
275
|
n/m2
|
n/m
|
|
Total revenue ex. pandemic vaccine3
|
|
7,045
|
11
|
7
|
|
Reported4
EPS5
|
|
$1.19
|
100
|
97
|
|
Core6
EPS
|
|
$1.63
|
55
|
53
|
|
Impact of pandemic vaccine on EPS
|
|
$(0.03)
|
n/m
|
n/m
|
Highlights of Total
Revenue in the quarter included:
- An
increase in Product Sales of 15% (11% at CER) to $7,257m. New
medicines7
Total Revenue improved by 30% (26% at CER) in the quarter to
$3,891m, including growth in Emerging Markets of 33% (30% at CER)
to $874m. Globally, new medicines represented 53% of Total Revenue
(Q1 2020: 47%). Q1 2020 benefitted from a low-to-mid single-digit
percentage increase in sales following short-term inventory
increases in the distribution channel, an indirect effect of the
COVID-19 pandemic
-
Oncology growth of 20% (16% at CER) to $3,024m, an increase in New
CVRM8 of
19% (15% at CER) to $1,306m. Respiratory & Immunology
(R&I), however, declined by 1% (4% at CER) to $1,546m,
predominately reflecting the impact of stocking of an authorised
generic version of Symbicort in the US during Q1 2020 and
phasing of COVID-19 impacts
- An
increase in Emerging Markets of 14% (10% at CER) to $2,592m, with
China growth of 19% (10% at CER) to $1,679m. In the US, Total
Revenue increased by 10% to $2,310m and in Europe by 28% (18% at
CER) to $1,546m
Guidance
The
Company reiterates 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 the pandemic COVID-19 vaccine. Similarly, the guidance
excludes the proposed acquisition of Alexion Pharmaceuticals, Inc.
(Alexion) which is intended to become AstraZeneca’s rare
disease unit and area of expertise. The acquisition is 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 April to December 2021 were to remain at
the average of rates seen in the quarter, 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 15% in the quarter (11% at CER) to $7,320m. Product
Sales grew by 15% (11% at CER) to $7,257m, driven primarily by the
performances of new medicines across Oncology and
BioPharmaceuticals, including Tagrisso and Farxiga. Total Revenue included $275m
of pandemic COVID-19 vaccine sales
- The
Reported Gross Profit Margin9 declined by three
percentage points to 74.3%, and the Core Gross Profit9 Margin declined by
three percentage points in the quarter to 74.6%. The performance
predominantly reflected the significant impact of equitable supply,
at no profit to AstraZeneca, of the pandemic COVID-19 vaccine,
together with an increasing contribution from profit-sharing
arrangements, primarily Lynparza, and the impact of the Chinese
National Reimbursement Drug List (NRDL) and the volume-based
procurement (VBP) patient-access programmes. A higher proportion of
Oncology sales and increasing patient access in China partially
offsets these impacts. These variations in gross margin performance
between quarters can be expected to continue
-
Reported Total Operating Expense increased by 13% (9% at CER) in
the quarter to $4,741m and represented 65% of Total Revenue (Q1
2020: 66%). Core Total Operating Expense increased by 15% (11% at
CER) to $4,136m and comprised 57% of Total Revenue (Q1 2020:
57%)
-
Reported and Core R&D Expense increased by 24% (19% at CER) in
the quarter to $1,713m and by 23% (18% at CER) to $1,638m,
respectively. The increases primarily reflected the investment in
Phase III and the advancement to Phase II of several clinical
development programmes, particularly in BioPharmaceuticals. The
Company continued to invest in its COVID-19 vaccine and potential
medicines to prevent and treat COVID-19
-
Reported SG&A Expense increased by 8% (4% at CER) in the
quarter to $2,929m; Core SG&A Expense increased by 10% (7% at
CER) to $2,399m, representing 33% of Total Revenue (Q1 2020:
34%)
-
Reported Other Operating Income and Expense10 grew by 146% (145%
at CER) in the quarter to $1,180m. Core Other Operating Income and
Expense increased by 147% (146% at CER) to $1,180m during the
period. The growth predominately reflected the $776m of income from
divestment of AstraZeneca’s 26.7% share of Viela Bio, Inc.
(Viela) as part of the acquisition by Horizon Therapeutics
plc
- The
Reported Operating Profit Margin increased by seven percentage
points in the quarter (eight at CER) to 26%; the Core Operating
Profit Margin increased by five percentage points (six at CER) to
34%. The performance predominately reflected the aforementioned
one-time benefit from Other Operating Income and
Expense10
-
Reported EPS of $1.19 in the quarter represented an increase of
100% (97% at CER). Core EPS grew by 55% (53% at CER) to $1.63. EPS
benefitted from a lower tax rate as a result of a non-taxable gain
from the divestment of AstraZeneca’s share of
Viela
Commercial summary
Oncology
Total
Revenue increased by 20% in the quarter (16% at CER) to
$3,024m.
Table 2: Q1 2021 - Select Oncology medicine Total Revenue
performances
|
|
|
|
Actual
|
CER
|
|
Medicine
|
|
$m
|
% change
|
% change
|
|
Tagrisso
|
|
1,149
|
17
|
13
|
|
Imfinzi
|
|
556
|
20
|
17
|
|
Lynparza
|
|
543
|
37
|
33
|
|
Calquence
|
|
209
|
n/m
|
n/m
|
|
Enhertu
|
|
40
|
n/m
|
n/m
|
New CVRM
Total
Revenue increased by 19% in the quarter (15% at CER) to
$1,306m.
Table 3: Q1 2021 - Select New CVRM medicine Total Revenue
performances
|
|
|
|
Actual
|
CER
|
|
Medicine
|
|
$m
|
% change
|
% change
|
|
Farxiga
|
|
625
|
54
|
50
|
|
Brilinta
|
|
374
|
(8)
|
(11)
|
|
Bydureon
|
|
103
|
3
|
1
|
|
Roxadustat
|
|
41
|
n/m
|
n/m
|
|
Lokelma
|
|
33
|
n/m
|
n/m
|
Respiratory & Immunology
Total
Revenue declined by 1% in the quarter (4% at CER) to
$1,546m.
Table 4: Q1 2021 - Select R&I medicine Total Revenue
performances
|
|
|
|
Actual
|
CER
|
|
Medicine
|
|
$m
|
% change
|
% change
|
|
Symbicort
|
|
691
|
(13)
|
(15)
|
|
Pulmicort
|
|
330
|
(13)
|
(18)
|
|
Fasenra
|
|
260
|
31
|
27
|
|
Breztri
|
|
27
|
n/m
|
n/m
|
COVID-19
Total
Revenue increased sequentially from $2m in Q4 2020 to $275m in the
first quarter of 2021.
Table 5: Q1 2021 - Pandemic
COVID-19 vaccine performance
|
|
|
|
Actual
|
CER
|
|
Medicine
|
|
$m
|
% change
|
% change
|
|
Pandemic COVID-19 vaccine
|
|
275
|
n/m
|
n/m
|
Emerging Markets
Total
Revenue increased by 14% in the quarter (10% at CER) to $2,592m,
however, the performance was offset by the decline of Pulmicort, which included an adverse impact
of four percentage points (four at CER) and suppressed the overall
Total Revenue growth in the quarter.
China
increased 19% (10% at CER) to $1,679m in the quarter and comprised
65% of Emerging Markets Total Revenue. New medicines, primarily
driven by Tagrisso in
Oncology and Forxiga in New
CVRM, delivered particularly encouraging growth. The Total Revenue
growth in the quarter, however, included an adverse impact of five
percentage points (four at CER) from the reduced sales of
Pulmicort which, restricted
overall revenue growth in the quarter. Ex-China Total Revenue
increased 6% (11% at CER) to $913m, with a particularly strong
performance in Middle East and Africa.
Business development
Acquisition of Acerta Pharma B.V. (Acerta) shares
In
December 2015, the Company agreed to acquire 55% of the entire
issued share capital of Acerta for an upfront payment of $2.5bn,
which was paid in 2016. A further amount of $1.5bn was paid in 2017
on receipt of the first US regulatory approval for Calquence. The agreement included
options that, if exercised, provided the opportunity for Acerta
shareholders to sell, and AstraZeneca to buy, the remaining 45% of
shares in Acerta. The final condition for these options to be
exercised was satisfied in November 2020 when Calquence received EU marketing
authorisation. AstraZeneca exercised its option to acquire the
remaining 45% of shares in Acerta in April 2021.
The
agreement initially provided that the remaining 45% of shares in
Acerta would be acquired at a price of approximately $3bn net of
certain costs and payments incurred by AstraZeneca and net of
agreed future adjusting items, using a pre-agreed pricing
mechanism. In October 2019, an amendment agreement came into effect
which was disclosed as part of year-to-date and Q3 2019 results,
changing the timing of payments and reducing the maximum
consideration required to be made to acquire the remaining
outstanding shares of Acerta if the options were exercised. The
payments are to be made in similar annual instalments in 2022, 2023
and 2024. The changes to the terms were reflected in the
assumptions that were used to calculate the amortised cost of the
option liability as of 31 March 2021 of $2,336m.
Sustainability summary
Recent
developments and progress against the Company’s
sustainability priorities are reported below:
AstraZeneca
and its sublicensee, Serum Institute of India Pvt. Ltd. (SII),
delivered over 48 million doses of its pandemic COVID-19 vaccine to
more than 120 countries through COVAX11, the multilateral
facility co-led by Gavi, the Vaccine Alliance, the Coalition for
Epidemic Preparedness Innovations, and the World Health
Organization (WHO), with c.80% of the doses going to low and
middle-income countries.
b)
Environmental protection
During
the period, the Company was recognised for its leadership in
building sustainable business models, as one of the top 7% of companies on
CDP’s
2020
Supplier Engagement Rating Leaderboard. By working with suppliers to reduce
their emissions, AstraZeneca is helping to drive science-based
climate action across the value chain, a key component of the
Company’s
Ambition Zero Carbon strategy.
c)
Ethics and transparency
The
Company released its seventh annual Sustainability Report and
Sustainability Data Summary via its website and social media. The
report was released in conjunction with the Annual Report and Form
20-F Information 2020. The report outlined progress and challenges
and aims for the future.
A more
extensive sustainability update is provided later in
this announcement.
Notes
The
following notes refer to pages one to five.
1.
Constant exchange
rates. These are financial measures that are not accounted for
according to generally accepted accounting principles (GAAP)
because they remove the effects of currency movements from Reported
results.
3.
Total revenue ex. pandemic vaccine is a
non-GAAP measure, which excludes the revenue impact from sales of
the pandemic COVID-19 vaccine during the pandemic period to help
facilitate a comparison to guidance.
4.
Reported financial
measures are the financial results presented in accordance with UK
and EU-adopted International Financial Reporting Standards (IFRSs),
and IFRS as issued by the International Accounting Standards Board
(IASB).
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.
Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new medicines are pillars
in the three disease areas (formally referred to as Therapy Areas)
of Oncology, Cardiovascular (CV), Renal & Metabolism (CVRM),
and R&I and are important platforms for future
growth.
8.
New CVRM comprises
Brilinta, Renal and
Diabetes medicines.
9.
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.
10.
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.
11.
18.4 million doses
of AstraZeneca’s pandemic COVID-19 vaccine and 29.9 million
of SII’s Covidshield vaccine.
12.
COVID-19 Vaccines
Global Access (COVAX) is a coalition co-led by CEPI, the Coalition
for Epidemic Preparedness Innovations, Gavi, the Vaccine Alliance
(Gavi), and the 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.
Table 6: Pipeline highlights
The
following table highlights significant developments in the
late-stage pipeline since the prior results
announcement:
|
Regulatory approval or other regulatory action
|
- Tagrisso - adjuvant NSCLC1 (EGFRm2): approval (CN)
- Tagrisso - adjuvant NSCLC (EGFRm):
positive opinion (EU)
- Imfinzi - bladder cancer (2nd line):
indication voluntarily withdrawn (US)
- Koselugo - NF13: positive opinion (EU)
|
|
Regulatory submission acceptance and/or submission
|
- Lynparza - breast cancer
(BRCAm4): submission voluntarily withdrawn
(CN)
- Brilique - CAD5/T2D6 CVOT7: submission voluntarily withdrawn (EU,
CN)
|
|
Major Phase III data readout or
othersignificantdevelopment
|
- Lynparza - adjuvant breast cancer
(BRCAm): Phase III primary endpoint met
- Farxiga - COVID-19: Phase III primary
endpoint not met
- roxadustat -
anaemia in CKD8: delay in regulatory decision due to
convening of advisory committee (US)
- nirsevimab -
RSV9: Phase III primary endpoint
met
- COVID-19 vaccine -
COVID-19: Phase III primary endpoint met (US trial)
|
Table 7: Pipeline anticipated major news flow
|
Timing
|
News
flow
|
|
H1 2021
|
- Tagrisso - adjuvant NSCLC (EGFRm):
regulatory decision (EU)
- Imfinzi +/- treme - NSCLC (1st line)
(POSEIDON): data readout (OS10)
- Calquence - CLL11 (R/R12) (ELEVATE R/R): regulatory
submission
- Koselugo - NF1 regulatory decision
(EU)
- Farxiga - CKD: regulatory decision
(US)
- Symbicort - mild asthma: regulatory
decision (EU)
- Fasenra - nasal polyps13: regulatory submission
- tezepelumab -
severe asthma: regulatory submission
- COVID-19 vaccine -
COVID-19: regulatory submission (US, JP)
- AZD7442 -
SARS-CoV-2: data readout, regulatory submission
|
|
H2 2021
|
- Imfinzi - unresectable14, Stage III NSCLC (PACIFIC-2): data
readout, regulatory submission
- Imfinzi - NSCLC (1st line) (PEARL):
data readout
- 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):
regulatory decision (CN)
- Lynparza - prostate cancer (1st line,
castration-resistant): data readout, regulatory
submission
- Enhertu - breast cancer (2nd line,
HER2+15): data readout16, regulatory submission
- Forxiga - CKD: regulatory decision (EU,
JP, CN)
- Farxiga - HF (HFpEF17): data readout
- Brilique - stroke (THALES): regulatory
decision (EU, CN)
- roxadustat -
anaemia in CKD: regulatory decision (US)
- PT027 - asthma:
data readout
- anifrolumab - lupus
(SLE18): regulatory decision (US, EU,
JP)
- nirsevimab - RSV
(MEDLEY): data readout
|
|
2022
|
- Imfinzi - NSCLC (1st line) (PEARL):
regulatory submission
- Imfinzi - ES-SCLC19: regulatory decision (CN)
- Imfinzi - LS-SCLC20: 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): data readout, regulatory
submission
- Enhertu - breast cancer (HER2 low):
data readout, regulatory submission
- Calquence - CLL: regulatory submission
(CN)
- Koselugo - NF1: regulatory submission
(JP, CN)
- Farxiga - HF (HFpEF): regulatory
submission
- roxadustat -
MDS21: data readout,
regulatory submission
- PT027 - asthma:
regulatory submission
- nirsevimab - RSV:
regulatory submission
|
Conference call
A
conference call and webcast for investors and analysts will begin
at 11:45 BST. Details can be accessed via astrazeneca.com.
Reporting
calendar
The
Company intends to publish its half-year and second-quarter results
on Thursday 29 July 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 in Oncology and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. Please visit
astrazeneca.com
and follow the Company on Twitter @AstraZeneca.
Contacts
For
details on how to contact the Investor Relations Team, please
click
here. For Media contacts, click
here.
Operating and financial review
All
narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m),
unless stated otherwise. The performance shown in this announcement
covers the three-month period to 31 March 2021 (the quarter or Q1
2021) compared to the three-month period to 31 March 2020 (Q1 2020)
respectively, unless stated otherwise.
Forward-looking
statements in this announcement do not reflect the impact of the
performance of AstraZeneca’s COVID-19 vaccine 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
Interim 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
alliance22, acquisition-related costs, which
include fair-value adjustments and the imputed finance charge
relating to contingent consideration on business combinations and
legal settlements
Details
on the nature of Core financial measures are provided on page 84 of
the Annual
Report and Form 20-F Information 2020. Reference should be
made to the Reconciliation of Reported to Core financial measures
table included in the
financial performance section in this
announcement.
Total revenue ex. pandemic vaccine is a new non-GAAP
financial measure introduced in the current period to enable
management to explain the financial impact of the COVID-19 vaccine
on the Group’s Total revenue.
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 Interim
Financial Statements in this announcement.
Ongoing
Collaboration Revenue is defined as Collaboration Revenue excluding
Initial Collaboration Revenue (which is defined as Collaboration
Revenue that is recognised at the date of completion of an
agreement or transaction, in respect of upfront consideration).
Ongoing Collaboration Revenue comprises, among other items,
royalties, milestone revenue and profit-sharing income. Reference
should be made to the Collaboration Revenue table in this operating
and financial review.
The
Company strongly encourages investors and analysts not to rely on
any single financial measure, but to review AstraZeneca’s
financial statements, including the Notes thereto and other
available Company reports, carefully and in their
entirety.
Due to
rounding, the sum of a number of dollar values and percentages may
not agree to totals.
Total Revenue
The
performance of the Company’s medicines is shown below, with a
geographical split of Product Sales shown in Note 7.
Table 8: Q1 2021 – Total Revenue by disease area
Specialty-care
medicines comprise all Oncology medicines, Brilinta, Lokelma, roxadustat and Fasenra. At 51% of Total Revenue (Q1
2020: 49%), specialty-care medicines increased by 19% in the year
(15% at CER) to $3,732m.
|
|
|
|
|
Actual
|
CER
|
|
|
|
$m
|
% of total
|
% change
|
% change
|
|
Oncology
|
|
3,024
|
41
|
20
|
16
|
|
BioPharmaceuticals
|
|
2,852
|
39
|
7
|
4
|
|
- New CVRM
|
|
1,306
|
18
|
19
|
15
|
|
- R&I
|
|
1,546
|
21
|
(1)
|
(4)
|
|
Other
medicines
|
|
1,169
|
16
|
(1)
|
(4)
|
|
COVID-19
|
|
275
|
4
|
n/m
|
n/m
|
|
Total Revenue
|
|
7,320
|
100
|
15
|
11
|
|
- Less
pandemic COVID-19 vaccine
|
|
275
|
4
|
n/m
|
n/m
|
|
Total Revenue ex. pandemic vaccine
|
|
7,045
|
96
|
11
|
7
|
Table 9: Q1 2021 – Disease area and medicine
performance
|
|
|
|
|
Actual
|
CER
|
|
|
|
$m
|
% of total
|
% change
|
% change
|
|
Oncology
|
|
2,981
|
41
|
19
|
15
|
|
-
Tagrisso
|
|
1,149
|
16
|
17
|
13
|
|
-
Imfinzi
|
|
556
|
8
|
20
|
17
|
|
-
Lynparza
|
|
543
|
7
|
37
|
33
|
|
-
Calquence
|
|
209
|
3
|
n/m
|
n/m
|
|
-
Koselugo
|
|
21
|
-
|
n/m
|
n/m
|
|
-
Enhertu
|
|
1
|
-
|
n/m
|
n/m
|
|
|
|
221
|
3
|
(1)
|
(6)
|
|
|
|
122
|
2
|
(26)
|
(30)
|
|
|
|
61
|
1
|
(21)
|
(26)
|
|
|
|
44
|
1
|
(12)
|
(15)
|
|
|
|
42
|
1
|
-
|
(6)
|
|
-
Others
|
|
12
|
-
|
(12)
|
(12)
|
|
BioPharmaceuticals: CVRM
|
|
1,912
|
26
|
12
|
9
|
|
-
Farxiga
|
|
624
|
9
|
54
|
50
|
|
-
Brilinta
|
|
374
|
5
|
(8)
|
(11)
|
|
-
Bydureon
|
|
103
|
1
|
3
|
1
|
|
-
Onglyza
|
|
101
|
1
|
(28)
|
(31)
|
|
-
Byetta
|
|
16
|
-
|
(20)
|
(20)
|
|
-
Other diabetes
|
|
13
|
-
|
3
|
(1)
|
|
-
Roxadustat
|
|
39
|
1
|
n/m
|
n/m
|
|
-
Lokelma
|
|
33
|
-
|
n/m
|
n/m
|
|
|
|
274
|
4
|
(9)
|
(12)
|
|
|
|
250
|
3
|
41
|
36
|
|
|
|
34
|
-
|
(48)
|
(49)
|
|
- Others
|
|
51
|
1
|
(13)
|
(16)
|
|
BioPharmaceuticals: R&I
|
|
1,541
|
21
|
(1)
|
(5)
|
|
- Symbicort
|
|
691
|
9
|
(13)
|
(15)
|
|
- Pulmicort
|
|
330
|
5
|
(13)
|
(18)
|
|
- Fasenra
|
|
260
|
4
|
31
|
27
|
|
- Daliresp/Daxas
|
|
60
|
1
|
14
|
12
|
|
- Breztri
|
|
27
|
-
|
n/m
|
n/m
|
|
- Bevespi
|
|
13
|
-
|
8
|
5
|
|
- Others
|
|
160
|
2
|
42
|
33
|
|
Other medicines
|
|
548
|
7
|
(2)
|
(5)
|
|
|
|
403
|
6
|
19
|
15
|
|
|
|
24
|
-
|
(72)
|
(72)
|
|
|
|
54
|
1
|
1
|
(5)
|
|
|
|
29
|
-
|
(20)
|
(22)
|
|
|
|
2
|
-
|
n/m
|
n/m
|
|
- Others
|
|
36
|
-
|
(19)
|
(20)
|
|
COVID-19
|
|
275
|
4
|
n/m
|
n/m
|
|
Pandemic
COVID-19 vaccine
|
|
275
|
4
|
n/m
|
n/m
|
|
Product Sales
|
|
7,257
|
99
|
15
|
11
|
|
Collaboration Revenue
|
|
63
|
1
|
43
|
42
|
|
Total Revenue
|
|
7,320
|
100
|
15
|
11
|
|
Total Revenue ex. pandemic vaccine
|
|
7,045
|
96
|
11
|
7
|
Table 10: Q1 2021 – Collaboration Revenue
|
|
|
|
|
Actual
|
CER
|
|
|
|
$m
|
% of total
|
% change
|
% change
|
|
Enhertu: share of gross profits
|
|
38
|
60
|
n/m
|
n/m
|
|
Roxadustat:
share of gross profits
|
|
2
|
3
|
(16)
|
(23)
|
|
Other
Ongoing Collaboration Revenue
|
|
23
|
37
|
(19)
|
(20)
|
|
Total
|
|
63
|
100
|
43
|
42
|
Other Collaboration Revenue included Zoladex, Farxiga, Eklira, Nexium OTC24 and other royalties. No Initial
Collaboration Revenue was recorded in the quarter.
Total Revenue summary
Oncology
Total Revenue of
$3,024m in the quarter; an increase of 20% (16% at CER). Oncology
represented 41% of overall Total Revenue (Q1 2020:
40%).
Tagrisso
Tagrisso has received regulatory approval in 17 countries,
including the US and China, for use as an adjuvant treatment of
EGFRm NSCLC patients, with four 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 89 countries,
including the US, China, in the EU and Japan. To date, 43
reimbursements have been granted in this setting, with further
decisions anticipated. These developments followed Tagrisso’s regulatory approval in
91 countries, including the US, China, in the EU and Japan, to
treat patients with EGFR T790M25 NSCLC, an indication in which 67
reimbursements have been granted.
Total
Revenue, entirely comprising Product Sales, amounted to $1,149m in
the quarter and represented growth of 17% (13% at CER).
Sales in the US increased by 12% to
$415m following the US Food and Drug Administration (FDA)
approval in 2020 for the adjuvant treatment of Stage IB to IIIA
EGFRm NSCLC patients, despite the decrease in lung cancer diagnoses
observed due to the impact of the COVID-19 pandemic.
Tagrisso sales in Emerging Markets increased by 9% in the
quarter (5% at CER) to $306m; the performance was adversely
impacted, however, due to the one-time effects of admission to the
China NRDL in March 2021 for the 1st-line setting and
the renewal in the 2nd-line setting,
respectively. Japan increased by 12% (7% at CER) to $172m. In
Europe, sales of $225m in the quarter represented an increase of
39% (26% at CER), driven by greater adoption in the 1st-line setting, as
more reimbursements were granted.
Imfinzi
Imfinzi has received regulatory approval in 71 countries,
including the US, China, in the European Union (EU) and Japan, with
34 reimbursements granted. Imfinzi is approved to treat patients
with unresectable Stage III NSCLC, whose disease has not progressed
following platinum-based chemoradiation therapy (CRT). Imfinzi has also been approved to treat ES-SCLC patients
in 53 countries, with eight reimbursements
granted.
Total
Revenue, entirely comprising Product Sales, amounted to $556m in
the quarter and represented growth of 20% (17% at CER),
predominantly for the treatment of unresectable, Stage III NSCLC
patients. The US increased by 2% to $292m, despite the COVID-19
related decrease in lung cancer diagnosis. In Japan, growth of 46%
(39% at CER) represented sales of $82m. Europe increased by 46%
(32% at CER) to $109m, reflecting a growing number of
reimbursements. Sales in Emerging Markets increased to $58m,
representing a growth of 74% (69% at CER) following recent
regulatory approvals and launches, including in China.
Lynparza
Lynparza has received regulatory approval in 81 countries
for the treatment of ovarian cancer; it has also been approved in
79 countries for the treatment of metastatic breast cancer, and in
59 countries for the treatment of
pancreatic cancer. Lynparza has received regulatory approval in 55 countries
for the 2nd-line
treatment of certain prostate-cancer patients.
Total
Revenue, entirely comprising Product Sales in the quarter, amounted
to $543m, reflecting growth of 37% (33% at CER). The strong
performance was geographically spread, with further launches across
multiple cancer types continuing globally. US Product Sales
increased by 28% to $253m, as the launches in prostate cancer and
1st-line
HRD+ ovarian cancer continued to take effect. Lynparza remained the leading medicine
in the poly ADP ribose polymerase-inhibitor (PARPi) class, as
measured by total prescription volumes. Product Sales in Europe
increased by 46% (33% at CER) to $149m, reflecting additional
reimbursements and increasing BRCAm-testing rates, as well as
successful recent 1st-line BRCAm ovarian
and homologous recombination repair gene mutation (HRRm) prostate
cancer launches.
Japan
Product Sales of Lynparza
amounted to $42m, representing growth of 23% (17% at CER). Emerging
Markets Product Sales were $87m, up by 54%. In China, Lynparza was admitted to the NRDL as a
1st-line
treatment for BRCAm ovarian cancer patients with effect from March
2021.
Enhertu
Total Revenue, predominately comprising Collaboration Revenue
recorded, amounted to $40m in the quarter. Global sales
amounted to $81m in the quarter (ex. Japan). US sales, recorded by
Daiichi Sankyo Company Limited (Daiichi Sankyo), amounted to $73m.
Enhertu
was approved at the end of 2019 by
the US FDA to treat
3rd-line
HER2+ breast cancer.
Calquence
Total
Revenue, entirely comprising Product Sales, amounted to $209m in
the quarter and represented growth of 138% (137% at CER), with the
overwhelming majority of sales in the US; the performance
benefitted from increased front-line use. The US FDA approved
Calquence for the treatment
of CLL in November 2019. In total, Calquence has received regulatory
approvals for this indication in 61 countries and 28 countries for
the treatment of patients with R/R mantle cell
lymphoma.
Koselugo
Total
Revenue, entirely comprising Product Sales in the US, amounted to
$21m in the quarter, following its launch during the second quarter
of 2020 to treat the rare disease NF1 in paediatric patients aged
two years and older who have symptomatic, inoperable plexiform
neurofibromas (PN).
Zoladex
Total
Revenue, predominantly comprising Product Sales, amounted to $226m
in the quarter and represented a decrease of 1% (5% at
CER).
Emerging
Markets Product Sales of Zoladex decreased by 8% (11% at CER) to
$136m. Product Sales in Europe increased by 6% (declined by 2% at
CER) to $37m while, in the Established Rest of World (RoW) region,
Product Sales increased by 11% (4% at CER) to
$43m.
Faslodex
Total
Revenue, entirely comprising Product Sales, amounted to $122m in
the quarter and represented a decline of 26% (30% at CER) following
the launch of several generic versions of the
medicine.
Emerging
Markets fell by 12% (13% at CER) to $43m, while US sales declined
by 60% to $9m; in Europe, sales fell by 35% (41% at CER) to $41m.
In Japan, sales declined by 3% (8% at CER) to $28m, driven by a
mandated price reduction in 2020.
Iressa
Total
Revenue, entirely comprising Product Sales, amounted to $61m in the
quarter and represented a decline of 21% (26% at CER). Emerging
Markets fell by 15% (20% at CER) to $53m, driven by the impact of
Iressa’s inclusion in
China’s VBP programme and subsequent price
reduction.
BioPharmaceuticals: CVRM
Total
Revenue increased by 12% in the quarter (9% at CER) to $1,916m and
represented 26% of Total Revenue (Q1 2020: 27%).
New
CVRM Total Revenue, which excludes Crestor and other legacy
medicines’ sales, increased by 19% in the year (15% at CER)
to $1,306m, mainly reflecting the strong performance of
Farxiga. New CVRM
represented 68% of overall CVRM Total Revenue in the quarter (Q1
2020: 65%).
Farxiga
Total
Revenue, predominantly comprising Product Sales, amounted to $625m
in the quarter and represented growth of 54% (50% at CER),
reflecting volume growth across the regions; Farxiga grew faster than the overall
SGLT2 class in the majority of markets.
Emerging
Market sales increased by 84% (85% at CER) to $260m in the quarter.
The performance reflected the addition of Forxiga to the Chinese NRDL in 2020;
the initial price impact has been more than offset by increased
access for patients.
In the
US, Product Sales increased by 16% to $131m, benefitting from the
recent regulatory approval to treat patients with heart failure
with reduced ejection fraction (HfrEF) with and without
T2D.
Product
Sales in Europe increased by 50% (36% at CER) to $174m in the
quarter, partly reflecting growth in the sodium-glucose
co-transporter-2 inhibitor class, the beneficial addition of CVOT
data to the label and the recent HfrEF regulatory approval in
November 2020. In Japan, sales to collaborator Ono Pharmaceutical
Co., Ltd, which records in-market sales, increased by 152% (140% at
CER) to $32m.
Brilinta
Total
Revenue, entirely comprising Product Sales, amounted to $374m in
the quarter, representing a decline of 8% (11% at CER). Global
demand continued to be adversely impacted by COVID-19, reflected in
fewer acute coronary syndrome hospital admissions and lower demand,
particularly in China. The performance in China, was also affected
following VBP in 2020, where the Company chose not to participate
further in the bidding process.
Emerging
Markets sales declined by 22% (23% at CER) to $105m, driven by the
aforementioned VBP impact. In the US, sales increased by 1% to
$166m with an increase in the average weighted duration of
treatment partly offset by the adverse effects of COVID-19,
reflected in fewer elective procedures. Sales of Brilique in Europe declined by 6% (14%
at CER) to $88m in the quarter, with the performance similarly
impacted by COVID-19.
Onglyza
Total
Revenue, entirely comprising Product Sales, amounted to $101m in
the quarter and represented a decline of 28% (31% at CER). Sales in
Emerging Markets, however, increased by 22% (19% at CER) to $58m,
driven by China’s performance and the growing domestic
DPP-426 class. US sales of Onglyza fell by 72% in the year to
$19m, while Europe sales increased by 1% (declined by 8% at CER) to
$15m, highlighting the shift away from the class.
Bydureon
Total
Revenue, entirely comprising Product Sales, amounted to $103m in
the quarter, representing a growth of 3% (1% at CER).
US
sales of $85m reflected an increase of 1% in the quarter. Sales in
Europe increased by 24% (14% at CER) to $15m.
Lokelma
Total
Revenue, comprising Product Sales, amounted to $33m in the quarter
(Q1 2020: $11m), an increase of 204% (200% at CER), despite the
adverse impact of COVID-19 on market growth. 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 countries to treat hyperkalaemia,
including in the EU, China and Japan, with further launches
anticipated.
Roxadustat
Total Revenue in China, predominantly comprising Product Sales,
amounted to $41m in the quarter. From January 2021, AstraZeneca
started recognising the overwhelming majority of China’s
revenue as Product Sales following an amendment to the existing
licence agreement entered into in July 2020.
Crestor
Total
Revenue, primarily comprising Product Sales, amounted to $274m in
the quarter and represented a decline of 9% (12% at
CER).
In
Emerging Markets, sales fell by 1% (4% at CER) to $189m. The
performance continued to be adversely impacted by China’s VBP
programme’s ongoing effects. US sales declined by 22% to
$22m. In Europe, sales decreased by 39% (43% at CER) to $21m while,
in Japan, where AstraZeneca collaborates with Shionogi Co., Ltd,
sales declined by 9% (13% at CER) to $31m.
In
February 2021, AstraZeneca announced that it had completed an
agreement to sell the rights to Crestor in over 30 countries in Europe
except the UK and Spain to Grünenthal GmbH
(Grünenthal).
BioPharmaceuticals: Respiratory & Immunology
Total
Revenue, which included Ongoing Collaboration Revenue of $5m from
Duaklir, Eklira and other medicines, declined by
1% in the quarter (4% at CER) to $1,546m and represented 21% of
Total Revenue (Q1 2020: 24%). The adverse impact of the decline of
Pulmicort sales reduced
Respiratory & Immunology Total Revenue growth by four
percentage points. In addition, stocking of respiratory medicines
due to COVID-19 and an inventory build for the authorised generic
version of Symbicort in the
US by the Company’s collaborator Prasco LLC (Prasco) in Q1
2020, both adversely impacted the performance comparison in the
quarter.
Symbicort
Total
Revenue, entirely comprising Product Sales, amounted to $691m in
the quarter and represented a decrease of 13% (15% at CER). The
performance relative to Q1 2020 predominately reflected the
aforementioned impact of stocking of an authorised generic version
of Symbicort in the US
during Q1 2020 and phasing of COVID-19 impacts. Symbicort remains the global
market-volume and value leader within the inhaled corticosteroid
(ICS) / long-acting beta-agonist (LABA) class. The global ICS/LABA
class growth developed slower, particularly in the US, due to the
impact of COVID-19 on the diagnosis of respiratory diseases, lower
levels of respiratory symptoms, and reduced use of
medicines.
US
sales fell by 14% in the quarter to $266m due to the stocking
effects. In March 2021, the US District Court for the Northern
District of West Virginia decided in favour of AstraZeneca and
determined that the asserted patent claims by Mylan Pharmaceuticals
Inc. (Mylan) and Kindeva Drug Delivery L.P., were not invalid or
unenforceable.
Emerging
Markets sales increased by 6% (3% at CER) to $165m. In Europe,
sales decreased by 14% (21% at CER) in the quarter to $168m. Sales
in Japan declined by 44% (47% at CER) to $31m in the quarter, the
performance predominately reflected
the ongoing adverse impact of generic competition and an
unfavourable price comparison due to the termination of the
co-promotion agreement by Astellas Pharma Inc.
Pulmicort
Total
Revenue, entirely comprising Product Sales, amounted to $330m in
the quarter and represented a decline of 13% (18% at CER),
as the continued effects of
COVID-19 impacted the hospital treatment of respiratory
patients.
Emerging
Markets, where Pulmicort
sales fell by 9% (14% at CER) in the quarter to $286m, represented
87% of the global total. Alongside the effects of COVID-19, the
performance in China continued to be impacted by a reduction in the
number of paediatric patients attending outpatient nebulisation
rooms and an increasing number of generic versions of Pulmicort.
Sales
in the US declined by 25% in the quarter to $17m, due to the fall
in the use of Pulmicort
Respules. In Japan, sales declined by 47% (49% at CER) to
$5m as a result of generic competition and fell in Europe by 37%
(43% at CER) to $16m.
Fasenra
Total
Revenue, entirely comprising Product Sales, increased by 31% (27%
at CER) to $260m in the quarter. The performance reflected growing
demand, despite the impact of COVID-19 on the level of new-patient
starts in several countries. Fasenra remained the leading novel
biologic in most markets in the new-to-brand prescription share for
patients with severe, uncontrolled asthma.
Sales
in the US grew by 30% in the quarter to $156m due to increased
demand and patient adherence seen using the Fasenra Pen home administration device.
This performance, however, was again partly offset by the
continuing and adverse effect of COVID-19. In Europe, sales of $63m
represented an increase of 37% (25% at CER); the benefit of ongoing
launches and additional reimbursement was offset by a decline in
the dynamic market due to COVID-19 restrictions. Sales in Japan
increased by 25% (19% at CER) to $26m due to increased demand and a
partial recovery in the treatment naïve market. In Emerging
Markets, sales decreased 51% (47% at CER) to $3m.
Daliresp/Daxas
Total
Revenue, entirely comprising Product Sales, amounted to $60m in the
quarter and represented an increase of 14% (12% at CER). US sales
increased by 20% to $54m.
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 nine countries.
Total
Revenue, entirely comprising Product Sales, amounted to $27m in the
quarter (Q1 2020: $4m). Sales in the US amounted to $12m (Q1 2020:
$nil), with an encouraging 20% market share in new patient starts.
Sales in Japan amounted to $5m (Q1 2020: $1m). In Europe, under the
name Trixeo, sales amounted
to $1m in the quarter (Q1 2020: $nil). Emerging Markets sales
amounted to $9m in the quarter (Q1 2020: $4m). Following inclusion
into the China NRDL with effect from March 2021, the number of
patients that have access to Breztri in China has significantly
increased.
Other medicines (outside the main disease areas)
Total
Revenue, primarily comprising Product Sales, amounted to $559m in
the quarter, a decline of 3% (6% at CER). Other medicines Total
Revenue represented 8% of overall Total Revenue (Q1 2020:
9%).
Nexium
Total
Revenue, predominantly comprising Product Sales, amounted to $409m
in the quarter, an increase of 18% (13% at CER). Emerging Markets
Product Sales of Nexium
increased by 25% (21% at CER) to $234m in the quarter, reflecting
an increase in Nexium
initiation in the hospital setting in China, as patients underwent
colonoscopy procedures that had been delayed by the
pandemic.
China
concluded another round of the VBP-programme in February 2021,
including Nexium (oral).
The Company, however, having submitted an initial price, chose not
to participate further in the bidding process and consequently
accepted a mandatory price reduction of 10%.
In
Japan, where AstraZeneca collaborates with Daiichi Sankyo, Product
Sales increased by 37% (30% at CER) to $103m, due to phasing of
orders from Daiichi Sankyo, while Product Sales in the US declined
by 20% to $32m. In Europe, Product Sales decreased by 18% (26% at
CER) to $18m.
In
March 2021, AstraZeneca and Daiichi Sankyo announced that
the two companies will end the joint sales promotion of
Nexium in Japan on the 14
September 2021, after which date AstraZeneca will market,
distribute, and promote Nexium.
Synagis
Total
Revenue, entirely comprising Product Sales, amounted to $24m in the
quarter, representing a decrease of 72%. Sales in Europe, wholly
comprising sales to AbbVie Inc. (AbbVie) made under the current
supply agreement for markets outside the US, amounted to $22m in
the quarter, a decrease of 69% reflecting low levels of RSV
infections globally due to the impact of COVID-19, the phasing of
orders from AbbVie and preparations for the reversion of commercial
rights outside the US, held by AbbVie since 1997, to AstraZeneca
upon the expiry of the current agreement on 30 June
2021.
COVID-19
COVID-19 vaccine
Total
Revenue, entirely comprised of Product Sales, amounted to $275m in
the quarter, reflecting the delivery of c.68 million27 doses worldwide. Sales in Europe were
$224m, Emerging Markets sales were $43m, and in Established RoW
sales amounted to $8m.
Regional Total Revenue
A geographical
split of Product Sales is shown in Note 7. For additional details,
refer to Table 45: Ongoing Collaboration
Revenue for
Collaboration Revenue recognised during Q1 2021 and Q1
2020.
Table 11: Q1 2021 – Regional Total Revenue
|
|
|
|
|
Actual
|
CER
|
|
|
|
$m
|
% of total
|
% change
|
% change
|
|
Emerging Markets
|
|
2,592
|
35
|
14
|
10
|
|
- China
|
|
1,679
|
23
|
19
|
10
|
|
- Ex-China
|
|
913
|
12
|
6
|
11
|
|
US
|
|
2,310
|
32
|
10
|
10
|
|
Europe
|
|
1,546
|
21
|
28
|
18
|
|
Established RoW
|
|
872
|
12
|
11
|
5
|
|
- Japan
|
|
620
|
8
|
12
|
7
|
|
- Canada
|
|
156
|
2
|
-
|
(4)
|
|
- Other Established RoW
|
|
96
|
1
|
23
|
6
|
|
Total
|
|
7,320
|
100
|
15
|
11
|
The
performance in Europe benefitted from $224m of sales from the
pandemic COVID-19 vaccine.
Table 12: Q1 2021 – Emerging Markets Total Revenue
disease-area performance
|
|
|
|
|
Actual
|
CER
|
|
|
|
$m
|
% of total
|
% change
|
% change
|
|
Oncology
|
|
762
|
29
|
7
|
4
|
|
BioPharmaceuticals
|
|
1,014
|
39
|
16
|
13
|
|
- New CVRM
|
|
472
|
18
|
43
|
41
|
|
- R&I
|
|
542
|
21
|
-
|
(4)
|
|
Other medicines
|
|
773
|
30
|
12
|
8
|
|
COVID-19
|
|
43
|
2
|
n/m
|
n/m
|
|
Total
|
|
2,592
|
100
|
14
|
10
|
Emerging
Markets Total Revenue grew by 14% (10% at CER) to $2,592m in the
quarter. New medicines represented 34% of Emerging Markets Total
Revenue in the quarter (Q1 2020: 29%). Speciality-care medicines
increased by 7% (3% at CER) to $912m and comprised 35% of Emerging
Markets Total Revenue in the quarter (Q1 2020: 38%).
Table 13: Q1 2021 – Notable new medicine Total Revenue
performances in Emerging Markets
|
|
|
|
|
Actual
|
CER
|
|
|
|
$m
|
% of total
|
% change
|
% change
|
|
Tagrisso
|
|
306
|
12
|
9
|
5
|
|
Forxiga
|
|
260
|
10
|
84
|
85
|
|
Brilinta
|
|
105
|
4
|
(22)
|
(23)
|
|
Lynparza
|
|
87
|
3
|
54
|
54
|
China
comprised 65% of Emerging Markets Total Revenue in the quarter and
increased by 19% (10% at CER) to $1,679m. New medicines, primarily
driven by Tagrisso in
Oncology and Forxiga in New
CVRM, delivered particularly encouraging growth and represented 31%
of China Total Revenue (Q1 2020: 27%); strong sales of Seloken, Nexium and Symbicort supplemented this
performance. The Total Revenue growth in the quarter, however,
included an adverse impact of five percentage points (four at CER)
from the reduced sales of Pulmicort which, restricted overall
revenue growth in the quarter.
Table 14: Q1 2021 – Ex-China Emerging Markets Total
Revenue
|
|
|
|
Actual
|
CER
|
|
|
|
$m
|
% change
|
% change
|
|
Ex-China Emerging Markets
|
|
913
|
6
|
11
|
|
- Russia
|
|
77
|
(9)
|
7
|
|
- Brazil
|
|
79
|
(11)
|
12
|
|
- Ex-Brazil Latin America
|
|
107
|
(1)
|
8
|
|
- Ex-China Asia Pacific
|
|
324
|
4
|
-
|
|
- Middle East and Africa
|
|
326
|
23
|
26
|
Ex-China
Emerging Markets Total Revenue, primarily comprising Product Sales,
increased by 6% in the quarter (11% at CER) to $913m. New medicines
represented 39% of ex-China Emerging Markets Total Revenue (Q1
2020: 32%), increasing by 26% (33% at CER) to $352m.
Table 15: Reported Profit and Loss
|
|
|
Q1 2021
|
Q1 2020
|
Actual
|
CER
|
|
|
|
$m
|
$m
|
% change
|
% change
|
|
Total Revenue
|
|
7,320
|
6,354
|
15
|
11
|
|
-
Product Sales
|
|
7,257
|
6,311
|
15
|
11
|
|
-
Collaboration Revenue
|
|
63
|
43
|
43
|
42
|
|
Cost of
Sales
|
|
(1,864)
|
(1,420)
|
31
|
25
|
|
Gross Profit
|
|
5,456
|
4,934
|
11
|
7
|
|
Gross Margin
|
|
74.3%
|
77.5%
|
-3
|
-3
|
|
Distribution
Expense
|
|
(99)
|
(87)
|
14
|
8
|
|
% Total Revenue
|
|
1.4%
|
1.4%
|
-
|
-
|
|
R&D
Expense
|
|
(1,713)
|
(1,388)
|
24
|
19
|
|
% Total Revenue
|
|
23.4%
|
21.8%
|
-2
|
-2
|
|
SG&A
Expense
|
|
(2,929)
|
(2,719)
|
8
|
4
|
|
% Total Revenue
|
|
40.0%
|
42.8%
|
+3
|
+3
|
|
Other
Operating Income & Expense
|
|
1,180
|
480
|
n/m
|
n/m
|
|
% Total Revenue
|
|
16.1%
|
7.6%
|
+9
|
+9
|
|
Operating Profit
|
|
1,895
|
1,220
|
55
|
54
|
|
Operating Profit Margin
|
|
25.9%
|
19.2%
|
+7
|
+8
|
|
Net
Finance Expense
|
|
(283)
|
(281)
|
1
|
(1)
|
|
Joint
Ventures and Associates
|
|
(4)
|
(4)
|
6
|
(1)
|
|
Profit Before Tax
|
|
1,608
|
935
|
72
|
69
|
|
Taxation
|
|
(46)
|
(185)
|
(75)
|
(76)
|
|
Tax
Rate
|
|
3%
|
20%
|
|
|
|
Profit After Tax
|
|
1,562
|
750
|
n/m
|
n/m
|
|
EPS
|
|
$1.19
|
$0.59
|
100
|
97
|
Table 16: Reconciliation of Reported Profit Before Tax to
EBITDA
|
|
|
Q1 2021
|
Q1 2020
|
Actual
|
CER
|
|
|
|
$m
|
$m
|
% change
|
% change
|
|
Reported
Profit Before Tax
|
|
1,608
|
935
|
72
|
69
|
|
Net
Finance Expense
|
|
283
|
281
|
1
|
(1)
|
|
Joint
Venture and Associates
|
|
4
|
4
|
6
|
(1)
|
|
Depreciation,
Amortisation and Impairment
|
|
797
|
841
|
(5)
|
(10)
|
|
EBITDA
|
|
2,692
|
2,061
|
31
|
29
|
Table 17: Reconciliation of Reported to Core financial
measures
|
Q1 2021
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Diabetes Alliance
|
Other
|
|
Core
% change
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
|
Gross Profit
|
5,456
|
7
|
17
|
-
|
-
|
5,480
|
10
|
7
|
|
Gross Profit Margin
|
74.3%
|
|
|
|
|
74.6%
|
(3)
|
(3)
|
|
Distribution Expense
|
(99)
|
-
|
-
|
-
|
-
|
(99)
|
14
|
8
|
|
R&D Expense
|
(1,713)
|
13
|
63
|
-
|
(1)
|
(1,638)
|
23
|
18
|
|
SG&A Expense
|
(2,929)
|
30
|
383
|
99
|
18
|
(2,399)
|
10
|
7
|
|
Total Operating Expense
|
(4,741)
|
43
|
446
|
99
|
17
|
(4,136)
|
15
|
11
|
|
Other Operating Income & Expense
|
1,180
|
-
|
1
|
-
|
(1)
|
1,180
|
n/m
|
n/m
|
|
Operating Profit
|
1,895
|
50
|
464
|
99
|
16
|
2,524
|
36
|
34
|
|
Operating Profit Margin
|
25.9%
|
|
|
|
|
34.5%
|
+5
|
+6
|
|
Net Finance Expense
|
(283)
|
-
|
-
|
49
|
47
|
(187)
|
11
|
16
|
|
Taxation
|
(46)
|
(10)
|
(101)
|
(31)
|
(2)
|
(190)
|
(43)
|
(44)
|
|
EPS
|
$1.19
|
$0.03
|
$0.27
|
$0.09
|
$0.05
|
$1.63
|
55
|
53
|
The
increases in Reported and Core Gross Profit by 11% (7% at CER) and
10% (7% at CER), respectively, reflected the 15% (11% at CER)
growth in Product Sales. The Reported Gross Profit
Margin declined by
three percentage points to 74.3%, and the Core Gross Profit Margin
declined by three percentage points in the quarter to 74.6%. The
performance predominantly reflected the significant impact of
equitable supply, at no profit to AstraZeneca, of the pandemic
COVID-19 vaccine, together with an increasing contribution from
profit-sharing arrangements, primarily Lynparza, and the impact of the Chinese
National Reimbursement Drug List (NRDL) and the volume-based
procurement (VBP) patient-access programmes. A higher proportion of
Oncology sales and increasing patient access in China partially
offsets these impacts. These variations in gross margin performance
between quarters can be expected to continue.
b)
Total Operating Expense
Reported
Total Operating Expense increased by 13% (9% at CER) to $4,741m and
represented 65% of Total Revenue (Q1 2020: 66%). Core Total
Operating Expense increased by 15% (11% at CER) to $4,136m and
comprised 57% of Total Revenue (Q1 2020: 57%).
The
increases in Reported and Core R&D Expense primarily reflected
investment in Phase III and the advancement to Phase II of several
clinical development programmes, particularly in
BioPharmaceuticals. The Company continued to invest in its COVID-19
vaccine and potential medicines for the prevention and treatment of
COVID-19, including other related costs, such as personal
protective equipment and colleague COVID-19 testing across the
Company. In the quarter, grant income of $270m has been recognised,
of which $209m has been offset against the US Clinical trial costs
for AZD1222.
Reported
and Core SG&A Expense grew primarily due to additional select
investment in new medicine launches and the Company’s
continued expansion in China.
c)
Other Operating Income and Expense
Reported
and Core Other Operating Income and Expense of $1,180m reflected an
increase of 146% (145% at CER) and 147% (146% at CER), respectively
and included:
-
Income from the divestment of AstraZeneca’s 26.7% share of
Viela as part of the acquisition by Horizon Therapeutics plc.
AstraZeneca received cash proceeds and profit of $776m upon closing
with the profit being recorded as other operating
income
- $309m
of income from an agreement with Grünenthal to divest
commercial rights to Crestor in over 30 countries in Europe,
except in the UK and Spain
Reported
Net Finance Expense increased by 1% (declined 1% at CER) in the
quarter to $283m reflecting lower interest rates on cash, cash
equivalents and other current investments and was partially offset
by lower discount unwind costs on acquisition-related liabilities,
including the Diabetes Alliance. The 11% (16% at CER) increase in
Core Finance Expense was driven by the aforementioned lower
interest rates.
The
Reported Tax Rate for the quarter was 3% (Q1 2020: 20%), and the
Core Tax Rate was 8% (Q1 2020: 20%). These tax rates benefitted
from the following one-off favourable impacts:
-
Non-taxable gain on the divestment of the investment in
Viela
-
Reduction of tax liabilities arising from updates to estimates of
prior period tax liabilities following settlements with tax
authorities
Excluding
these benefits, the Reported and Core Tax Rates would have been
c.20%, within the indication provided for 2021.
The net
cash tax paid for the quarter was $332m (Q1 2020: $477m),
representing 21% of Reported Profit Before Tax (Q1 2020:
51%).
In its
Spring Budget, the UK Government has announced that UK Corporation
Tax will increase from 19% to 25% from 1 April 2023. It is
anticipated that this will be substantively enacted during Q2 2021,
which will result in a tax charge during that quarter arising from
the recalculation of deferred tax balances to the 25% tax
rate.
Reported
EPS of $1.19 in the quarter represented an increase of 100% (97% at
CER); Core EPS increased by 55% (53% at CER) to $1.63.
Table 18: Cash Flow
|
|
|
Q1 2021
|
Q1 2020
|
Change
|
|
|
$m
|
$m
|
$m
|
|
Reported Operating Profit
|
|
1,895
|
1,220
|
675
|
|
Depreciation, Amortisation and Impairment
|
|
797
|
841
|
(44)
|
|
Decrease/(increase) in Working Capital and Short-Term
Provisions
|
|
1,210
|
(445)
|
1,655
|
|
Gains on Disposal of Intangible Assets
|
|
(310)
|
(358)
|
48
|
|
Gains on Disposal of Investments in Associates and Joint
Ventures
|
|
(776)
|
-
|
(776)
|
|
Non-Cash and Other Movements
|
|
(363)
|
(462)
|
99
|
|
Interest Paid
|
|
(187)
|
(180)
|
(7)
|
|
Taxation Paid
|
|
(332)
|
(477)
|
145
|
|
Net Cash Inflow from Operating Activities
|
|
1,934
|
139
|
1,795
|
|
Net Cash Inflow before Financing Activities
|
|
2,489
|
148
|
2,341
|
|
Net Cash Outflow from Financing Activities
|
|
(2,731)
|
(2,362)
|
(369)
|
The
increase in Net Cash Inflow from Operating Activities of $1,795m
was primarily driven by the decrease in working capital, of which
$996m related to the movement in pandemic COVID-19 vaccine working
capital balances within trade and other payables, trade and other
receivables and inventories.
The
increase in Net Cash Inflow before Financing Activities of $2,341m
was a result of the aforementioned improvement in Net Cash Inflow
from Operating Activities, as well as cash proceeds received of
$776m from the divestment of AstraZeneca’s 26.7% shareholding
in Viela.
Capital Expenditure
Capital
Expenditure amounted to $220m in the quarter, compared to $186m in
Q1 2020. 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 several
limited-sized projects.
Table 19: Net Debt summary
|
|
|
At 31 Mar 2021
|
At 31 Dec 2020
|
At 31 Mar 2020
|
|
|
$m
|
$m
|
$m
|
|
Cash
and cash equivalents
|
|
7,636
|
7,832
|
3,413
|
|
Other
investments
|
|
129
|
160
|
804
|
|
Cash and investments
|
|
7,765
|
7,992
|
4,217
|
|
Overdrafts
and short-term borrowings
|
|
(581)
|
(658)
|
(691)
|
|
Lease
liabilities
|
|
(680)
|
(681)
|
(653)
|
|
Current
instalments of loans
|
|
(1,461)
|
(1,536)
|
(1,598)
|
|
Non-current
instalments of loans
|
|
(17,410)
|
(17,505)
|
(15,634)
|
|
Interest-bearing loans and borrowings
(Gross Debt)
|
|
(20,132)
|
(20,380)
|
(18,576)
|
|
Net
derivatives
|
|
162
|
278
|
(54)
|
|
Net Debt
|
|
(12,205)
|
(12,110)
|
(14,413)
|
Net
Debt of $12,205m represented an increase of $95m in the year to
date.
Details
of the committed undrawn bank facilities are disclosed within the
going-concern section of Note 1.
During
the three months, there were no changes to the Company’s
credit ratings issued by Standard and Poor’s (long term:
BBB+, short term A-2) and Moody’s (long term: A3, short term
P-2).
Capital allocation
The
Board’s aim is to continue to strike a balance between the
interests of the business, financial creditors and the
Company’s shareholders. After providing for investment in the
business, supporting the progressive dividend policy and
maintaining a strong, investment-grade credit rating, the Board
will keep under review potential investment in immediately
earnings-accretive, value-enhancing opportunities.
Foreign exchange
The
Company’s transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies’ reporting currency.
Foreign-exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the
Company’s external dividend payments, paid principally in
pounds sterling and Swedish krona, are fully hedged from
announcement to payment date.
Table 20: Currency sensitivities
The
Company provides the following currency-sensitivity
information:
|
|
|
|
Average
Exchange
Rates
versus USD
|
|
Annual Impact of 5% Strengthening in Exchange
Rate versus USD ($m)29
|
|
Currency
|
Primary Relevance
|
|
|
|
% change
|
Product Sales
|
Core Operating Profit
|
|
CNY
|
Product
Sales
|
|
6.90
|
6.48
|
6
|
312
|
186
|
|
EUR
|
Product
Sales
|
|
0.88
|
0.83
|
5
|
189
|
58
|
|
JPY
|
Product
Sales
|
|
106.74
|
105.98
|
1
|
140
|
91
|
|
|
|
|
|
|
|
239
|
108
|
|
GBP
|
Operating
Expense
|
|
0.78
|
0.73
|
7
|
31
|
(84)
|
|
SEK
|
Operating
Expense
|
|
9.20
|
8.39
|
9
|
5
|
(59)
|
AstraZeneca’s
sustainability approach has three priority areas33, 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:
AstraZeneca
and its sublicensees, including SII, delivered over 48 million
doses of its pandemic COVID-19 vaccine to more than 110 countries
through COVAX, the multilateral facility co-led by Gavi, the
Coalition for Epidemic Preparedness Innovations, and the World
Health Organization (WHO), with c.80% of the doses going to low and
middle-income countries.
In
April 2021, Chief Executive Officer Pascal Soriot joined Heads of
State, Ministers and global leaders at the Gavi COVAX Advance
Market Commitment investment opportunity to highlight AstraZeneca's
commitment to broad and equitable access, and its collaboration
with COVAX.
Following
the Company's launch in November 2020 of the Partnership for Health
System Sustainability and Resilience (PHSSR) 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. AstraZeneca co-led the first virtual
PHSSR Summit held between 15-19 March 2021, which brought together
over 50 leading experts from eight pilot countries, including
Germany, France, the UK, Italy, Spain, Vietnam, Russia and Poland.
Participants also included representatives from bodies such as The
Organisation for Economic Co-operation and Development, the WHO,
the World Heart Federation, and the International Society of
Nephrology to discuss the future of health in a post-COVID-19
world. Over 1,200 people registered from more than 65
countries.
During
the period, the Company’s Healthy Heart Africa (HHA)
programme expanded into the Republic of Côte
d'Ivoire, its first French-speaking country of operation,
signing a memorandum of understanding with the country’s
Ministry of Health. Since the programme launched in 2015, HHA has
conducted over 17 million blood pressure screenings, identified
over three million elevated readings, activated over 900 sites and
trained over 7,600 healthcare workers and volunteers.
In
March 2021, the Company's Young Health Programme (YHP) released its
annual report. The report noted that in 2020, the programme
directly delivered health information to more than one million
youth, trained 55,000 peer educators and health professionals,
engaged more than 1,300 employees as volunteers and expanded into
six new countries. It also showcased the immediate contribution of
its latest partner, UNICEF, and its focus on advocacy and policy
change. Independent external evaluations of YHP completed in 2020
in Brazil, Indonesia, and Kenya found YHP's community-based
delivery model and peer educator approach leads to sustained
behaviour change among youth. The assessment also confirmed that
when health services are more accessible to young people, they will
use them more often and be more satisfied. Two new learning modules
developed by UNICEF were launched, including substance abuse and
air pollution, respectively.
b)
Environmental protection
In
April 2021, AstraZeneca launched an interactive EcoPharmacoVigiliance
dashboard measuring potential environmental risks associated
with patient use of the Company's life-saving medicines. The
dashboard is part of the AstraZeneca's commitment to lead in the
environmental safety of its medicines and respond to stakeholder
concerns associated with pharmaceuticals in the environment. The
dashboard collates published measured environmental concentrations
of the active ingredients in AstraZeneca's products and presents
data based on potential risk.
During
the period, the Company was recognised for its leadership in
building sustainable business models, as one of the top 7% of companies on
CDP’s
2020
Supplier Engagement Rating Leaderboard. By working with suppliers to reduce
their emissions, AstraZeneca is helping to drive science-based
climate action across the value chain, a key component of the
Company’s
Ambition Zero Carbon strategy.
In
March 2021, AstraZeneca published its first voluntary
disclosure in line with the recommendations of the Taskforce
on Climate-related Financial Disclosures (TCFD),
describing its progress and actions as at 31 December 2020. All the
Company's business operations worldwide are in scope unless
otherwise stated. Full TCFD disclosure will be provided according
to the UK’s Financial Conduct Authority’s enhanced
listing rules, which promote better climate-related financial
disclosures for UK premium-listed companies. The rule will apply
for accounting periods beginning on or after 1 January 2021,
meaning that AstraZeneca’s first annual financial report to
include TCFD would be published in spring 2022.
During the period, the
Innovative Medicines Initiative (IMI) PREMIER project, in which the Company
is a leading participant, launched a
novel database and digital assessment system for characterising the environmental
risks of medicines and making environmental data more visible and
accessible to industry, academia, regulators and the
public.
The company joined a new UK collaboration with
CPI in the
Medicines Manufacturing Innovation Centre that aims to revolutionise the
development of new manufacturing processes for oligonucleotides
(short DNA or RNA molecules) to achieve sustainable large scale
manufacturing.
The
Company was recognised by the UK
Government in March 2021 as one of 30 FTSE 100 companies to
have signed up to the United Nation’s Race to Zero
campaign – the largest ever
global alliance committed to achieving net zero carbon emissions by
2050 at the latest - leading the way in the world’s
transition to a low carbon economy, as well as committing to align
with UK government ambitions and eliminate their contribution to
climate change by 2050.
In March 2021, the Company was also recognised in the
BloombergNEF (BNEF)
net zero research tool as achieving the top score for its Ambition
Zero Carbon strategy, out of 400 of the largest corporations in
heavy-emitting industries.
c)
Ethics and transparency
The
Company released its seventh annual Sustainability Report and
Sustainability Data Summary via its website and social media. The
report was released in conjunction with the Annual Report and Form
20-F Information 2020. The report outlined progress and challenges
and aims for the future.
For
more details on AstraZeneca’s sustainability ambition,
approach and targets, please refer to the latest Sustainability Report
2020 and Sustainability Data
Summary 2020. Additional information is available within
AstraZeneca’s analyst interactive
reporting centre or alternatively at astrazeneca.com/sustainability.
Research and development
As the COVID-19
pandemic persists, the Company continues to evaluate impacts on the
initiation of clinical trials, ongoing recruitment and follow-ups.
It is prudent to assume that some delays will continue to
arise.
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/investor-relations.html.
Highlights of developments in the Company’s late-stage
pipeline since the prior results announcement are shown
below:
Table 21: 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
- capivasertib -
breast, prostate cancer
- monalizumab - head
& neck cancer
- camizestrant -
breast cancer
- datopotamab
deruxtecan - lung cancer
CVRM
- Farxiga - multiple
indications
- roxadustat -
anaemia in CKD
Respiratory & Immunology
- Fasenra - multiple
indications
- Breztri/Trixeo - asthma
- tezepelumab -
severe asthma
- PT027 -
asthma
- anifrolumab - lupus
(SLE)
- brazikumab -
inflammatory bowel disease
Other
- nirsevimab -
RSV
COVID-19
- COVID-19 vaccine -
COVID-19
- AZD7442 -
SARS-CoV-2
|
|
Total
projects
in
clinical development
|
146
|
|
|
Total
projects
in
total pipeline
|
166
|
|
Oncology
AstraZeneca
shared an update on its innovative early oncology pipeline, across
multiple strategic platforms, during the virtual American
Association of Cancer Research Annual Meeting in early April 2021.
Highlights included five presentations for AZD5305, a
next-generation PARP1-selective inhibitor. Additionally, the
Company also highlighted research across multiple presentations
that showcased novel technologies, including myeloid gene
expression. These technologies enable early detection of disease
recurrence to inform earlier interventions for patients who are
more likely to benefit from treatment.
In
April 2021, Tagrisso was
recommended for marketing authorisation in the EU for the adjuvant
treatment of adult patients with early-stage (IB, II and IIIA)
EGFRm NSCLC after complete tumour resection with curative intent.
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion on
results from the ADAURA Phase III trial.
During
the period, Tagrisso
received Chinese regulatory approval for the adjuvant treatment of
patients with early-stage (IB, II and IIIA) EGFRm NSCLC after
tumour resection with curative intent. The approval was based on
the positive results from the ADAURA Phase III trial.
Table 22: Key Tagrisso
Phase III trials
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
NeoADAURA
(neo-adjuvant
EGFRm NSCLC)
|
Placebo
or Tagrisso
|
First
data anticipated: 2022+
|
Recruitment
ongoing
|
|
ADAURA
(adjuvant
EGFRm NSCLC)
|
Placebo
or Tagrisso
|
FPCD:
Q4 2015
|
Trial
unblinded early due to overwhelming efficacy
Regulatory
approval (US, CN)
|
|
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
|
In
February 2021, in consultation with the US FDA, AstraZeneca
announced the voluntary withdrawal of the Imfinzi indication in the US for
previously treated adult patients with locally advanced or
metastatic bladder cancer as the DANUBE Phase III trial did not
confirm the efficacy observed from Study 1108, a single-arm Phase
I/II trial, the basis for the US accelerated approval.
Table 23: Key Imfinzi Phase
III trials in lung cancer
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
AEGEAN
(neo-adjuvant
NSCLC)
|
SoC37
chemotherapy +/- Imfinzi,
followed by surgery, followed by placebo or Imfinzi
|
FPCD:
Q1 2019
First
data anticipated: 2022+
|
Recruitment
ongoing
|
|
(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
|
FPCD:
Q3 2020
First
data anticipated: 2022+
|
Recruitment
ongoing
|
|
MERMAID-2
(Stage
II-III
NSCLC
with minimal residual disease)
|
Placebo or
Imfinzi
|
FPCD:
Q4 2020First data anticipated: 2022+
|
Recruitment
ongoing
|
|
PACIFIC-2
(Stage
III unresectable locally advanced NSCLC
(concurrent
CRT))
|
Placebo or
Imfinzi
|
FPCD:
Q2 2018
LPCD:
Q3 2019
First
data anticipated: H2 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: H2 2021
|
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
|
PFS39
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 24: Key Imfinzi Phase
III trials in tumour types other than lung cancer
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
POTOMAC
(non-muscle
invasive bladder cancer)
|
SoC
BCG40 orSoC BCG + Imfinzi
|
FPCD:
Q4 2018
LPCD:
Q3 2020
First
data anticipated: 2022+
|
Recruitment
completed
|
|
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
|
TACE42
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
LPCD:
Q4 2020
First
data anticipated: 2022+
|
Recruitment
completed
|
|
MATTERHORN
(resectable
gastric and gastroesophageal cancer)
|
Neoadjuvant
Imfinzi + FLOT chemotherapy
+/- adjuvant Imfinzi
|
FPCD:
Q4 2020
First
data anticipated: 2022+
|
Recruitment
ongoing
|
|
KUNLUN
(locally
advanced, unresectable oesophageal squamous cell
carcinoma)
|
Definitive
CRT or CRT + Imfinzi
|
FPCD:
Q4 2020
First
data anticipated: 2022+
|
Recruitment
ongoing
|
|
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
|
|
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 Designation43 (US)
|
|
TOPAZ-1
(Stage
IV, 1st-line biliary-tract cancer)
|
Gemcitabine
and cisplatin SoC chemotherapy or SoC + Imfinzi
|
FPCD:
Q2 2019
LPCD:
Q4 2020
First
data anticipated: 2022
|
Recruitment
completed
|
During
the period, the Company announced that the OlympiA Phase III trial
of Lynparza had
demonstrated early efficacy. An independent data monitoring
committee (IDMC) concluded that the trial crossed the superiority
boundary for invasive disease-free survival versus placebo. The
initial results demonstrated a sustainable, clinically relevant
treatment effect for Lynparza versus placebo in patients
with germline BRCA-mutated HER2-negative early breast cancer. As a
result, the IDMC intends to move forward with an earlier than
anticipated primary analysis. In China, the Company decided to
voluntarily withdraw the Lynparza regulatory submission for
BRCAm advanced breast cancer due to insufficient regional data from
the OlympiAD Phase III trial.
Table 25: 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
|
Recruitment
completed
Early
efficacy readout
|
|
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
|
|
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
|
Table 26: Key Enhertu
trials
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
DESTINY-Breast02-U301,
Phase III
(Stage
IV, HER2+ breast cancer post trastuzumab emtansine)
|
SoC
chemotherapy or Enhertu
|
FPCD:
Q4 2018
LPCD:
Q4 2020
First
data anticipated: 2022
|
Recruitment completed
|
|
DESTINY-Breast03-U302,
Phase III
(Stage
IV, HER2+ 2nd-line breast cancer)
|
Trastuzumab
emtansine or Enhertu
|
FPCD:
Q4 2018
LPCD:
Q2 2020
First
data anticipated: H2 2021
|
Recruitment completed
|
|
DESTINY-Breast04,
Phase III
(Stage
IV, HER2-low 2nd-line breast cancer)
|
SoC
chemotherapy or Enhertu
|
FPCD:
Q4 2018
LPCD:
Q4 2020
First
data anticipated: 2022
|
Recruitment completed
|
|
DESTINY-Breast06,
Phase III
(Stage
IV, HER2-low breast cancer post endocrine therapy)
|
SoC
chemotherapy or Enhertu
|
FPCD:
Q3 2020
First
data anticipated: 2022+
|
Recruitment
ongoing
|
|
DESTINY-Breast09,
Phase III
(Stage
IV, HER2+ 1st-line breast cancer)
|
SoC
chemotherapy trastuzumab + pertuzumab or Enhertu + pertuzumab or Enhertu
|
First
data anticipated
2022+
|
Initiating
|
|
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-Gastric02,
Phase II
(Stage
IV, HER2+ gastric cancer)
|
Enhertu
|
FPCD:
Q4 2019
First
data anticipated: H2 2021
|
Recruitment
ongoing
|
During
the period, the timelines for first data from the DESTINY-Breast02
and DESTINY-Breast04 Phase III trials, were updated from H2 2021 to
2022, respectively. These changes followed a conversion from
initial event rate assumptions to actual observed event rates in
the trials.
Table 27: Camizestrant Phase III trials
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
SERENA-4
(ER+,
HER2-, advanced breast cancer)
|
Palbociclib
+ anastrazole or palbociclib + camizestrant
|
FPCD:
Q1 2021
First
data anticipated: 2022+
|
Recruitment
ongoing
|
f)
Datopotamab deruxtecan
Table 28: Datopotamab deruxtecan Phase III trials
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
TROPION-LUNG01
(Stage
IV, 2nd-line NSCLC)
|
SoC
chemotherapy or datopotamab deruxtecan
|
First
data anticipated: 2022+
|
Initiating
|
In
April 2021, selumetinib was recommended for conditional marketing
authorisation in the EU for the treatment of symptomatic,
inoperable PN in paediatric patients with NF1 aged three years and
above. The CHMP of the EMA based its positive opinion on results
from the National Cancer Institute Cancer Therapy Evaluation
Program-sponsored SPRINT Stratum 1 Phase II trial.
CVRM
During
the period, AstraZeneca withdrew Brilique’s regulatory
submissions, based on the THEMIS Phase III trial, for CAD in Europe
and China to prevent against first heart attack or stroke. The
THEMIS Phase III trial showed a statistically significant reduction
in the primary composite endpoint of major adverse CV events at 36
months with aspirin plus Brilinta 60mg versus aspirin alone in
patients with CAD and type-2 diabetes (T2D) at high risk of a first
heart attack or stroke. The primary composite endpoint was driven
by a reduction in heart attack and stroke, but these benefits were
accompanied by an increased risk of bleeding. The US FDA approved
Brilinta in June 2020 for
the treatment of CAD based on the positive results from the THEMIS
Phase III trial.
In
April 2021, AstraZeneca and Saint Luke’s Mid America Heart
Institute announced high-level results of the primary analysis from
the DARE-19 Phase III trial, which assessed the potential of the
medicine to treat patients hospitalised with COVID-19 who are at
risk of developing serious complications. The trial did not achieve
statistical significance for the primary endpoint of prevention
measuring organ dysfunction and all-cause mortality, and the
primary endpoint of recovery measuring a change in clinical status
(from early recovery to death), at 30 days. The safety and
tolerability profile observed in the trial was consistent with the
known safety profile of the medicine. The results will be presented
at the American College of Cardiology Scientific Sessions in May
2021.
Table 29: Key large CVRM Phase III outcomes trials
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
Brilinta
|
|
THALES
(c.11,000
patients with acute ischaemic stroke44 or transient ischaemic
attack)
|
Aspirin
plus placebo or aspirin plus Brilinta 90mg BID
|
FPCD:
Q1 2018
LPCD:
Q4 2019
|
Primary
endpoint met
Regulatory
approval (US)
|
|
Farxiga
|
|
DELIVER
(c.6,300
patients with HF (HFpEF) with and without T2D)
|
Placebo or
Farxiga 10mg
QD
|
FPCD:
Q4 2018
LPCD:
Q4 2020
First
data anticipated: H2 2021
|
Recruitment
completed
Fast
Track45 designation (US)
|
|
DAPA-CKD
(c.4,300
patients with CKD, with and without T2D)
|
Placebo or
Farxiga 10mg
QD
|
FPCD:
Q1 2017
LPCD:
Q1 2020
|
Trial
stopped early based on recommendation from an IDMC
Primary
endpoint and secondary endpoints met
Breakthrough
Therapy Designation, Priority Review (US)
|
|
DAPA-MI
(c.6,400
patients with confirmed MI, either STEMI or NSTEMI, within the
preceding 7 days)
|
Placebo or
Farxiga 10mg
QD
|
FPCD:
Q4 2020
First
data anticipated: 2022+
|
Recruitment
ongoing
|
During
the period, FibroGen, Inc. (FibroGen) provided an update on certain
prior disclosures relating to the US primary CV safety
analyses from the roxadustat Phase III programme to treat
anaemia of CKD.
In
March 2021, AstraZeneca and FibroGen announced that the US FDA
would convene a Cardiovascular and Renal Drugs Advisory Committee
meeting to review the new drug application for roxadustat. The
meeting has been tentatively scheduled for 15 July 2021. Roxadustat
is approved in China, Japan, and Chile to treat anaemia in CKD in
non-dialysis dependent and dialysis-dependent adult patients and is
under regulatory review in the EU.
Respiratory & Immunology
Table 30: Key Fasenra
lifecycle management Phase III trials
During
the period, the Company announced that the first patients had
commenced dosing in three trials evaluating Fasenra in dermatological indications,
in reference to the Phase III FJORD trial in bullous pemphigoid and
two-Phase II trials in atopic dermatitis (HILLIER) and chronic
spontaneous urticaria (ARROYO).
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
OSTRO
(severe
bilateral nasal polyps)
|
Placebo
or Fasenra 30mg
Q8W46 SC47
|
FPCD:
Q1 2018
LPCD:
Q2 2019
|
Co-primary
endpoints met
|
|
RESOLUTE
(moderate
to very severe COPD with a history of exacerbations and elevated
peripheral blood eosinophils)
|
Placebo
or Fasenra 100mg Q8W
SC
|
FPCD:
Q4 2019
First
data anticipated: 2022+
|
Recruitment
ongoing
|
|
MANDARA
(eosinophilic
granulomatosis with polyangiitis48)
|
Mepolizumab
3x100mg Q4W or
Fasenra 30mg
SC
|
FPCD:
Q4 2019
First
data anticipated: 2022+
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
|
NATRON
(hyper-eosinophilic
syndrome49
|
Placebo
or Fasenra 30mg Q4W
SC
|
FPCD:
Q3 2020
First
data anticipated: 2022
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
|
MESSINA
(eosinophilic
oesophagitis50)
|
Placebo
or Fasenra 30mg Q4W
SC
|
FPCD:
Q4 2020
First
data anticipated: 2022
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
|
FJORD
|
Placebo
or Fasenra 30mg Q4W
SC
|
FPCD:
Q2 2021
First
data anticipated: 2022+
|
Recruitment
ongoing
|
Table 31: Key Breztri Phase III trials
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
KALOS
(asthma)
|
Budesonide/formoterol
or Breztri
|
FPCD:
Q1 2021
First
data anticipated: 2022+
|
Recruitment
ongoing
|
|
LOGOS
(asthma)
|
Budesonide/formoterol
or Breztri
|
FPCD:
Q1 2021
First
data anticipated: 2022+
|
Recruitment
ongoing
|
During
the period, the Phase II trial of anifrolumab in lupus nephritis
concluded. Although the primary endpoint was not met, the trial
results provided valuable insights that have informed the Phase III
programme, planned to start in the second half of 2021. The full
results from the Phase II trial will be presented at a forthcoming
medical meeting.
Table 32: Key anifrolumab Phase III trials
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
TULIP
1
(moderate
to severely active SLE)
|
Placebo
or anifrolumab 150mg or 300mg IV Q4W
|
FPCD:
Q4 2015
LPCD:
Q4 2017
|
Primary
endpoint not met
Fast
Track designation (US)
|
|
TULIP
2
(moderate
to severely active SLE)
|
Placebo
or anifrolumab 300mg IV Q4W
|
FPCD:
Q4 2015
LPCD:
Q4 2017
|
Primary
endpoint met
Fast
Track designation (US)
|
|
TULIP
LTE
(moderate
to severely active SLE)
|
Placebo
or anifrolumab 300mg IV Q4W
|
FPCD:
Q2 2016
LPCD:
Q4 2018
First
data anticipated: 2022
|
Recruitment
completed
Fast
Track designation (US)
|
d)
Tezepelumab (severe asthma)
During
the period, AstraZeneca and Amgen Inc. presented positive results
from the NAVIGATOR Phase III trial for tezepelumab at the American
Academy of Allergy Asthma and Immunology Virtual Annual Meeting,
held between 26 February and 1 March 2021.
When
added to SoC52, tezepelumab achieved a 56% reduction
(p<0.001) in annualised asthma exacerbation rate (AAER) over 52
weeks when compared to placebo. In a pre-planned subgroup analysis,
in patients with baseline eosinophil counts less than 300 cells per
microlitre, tezepelumab achieved a statistically significant and
clinically meaningful 41% reduction (p<0.001) in AAER.
Importantly, clinically meaningful AAER reductions were observed in
two additional subgroups; 39% reduction in patients with baseline
eosinophil counts less than 150 cells per microlitre; 70% reduction
in patients with greater than or equal to 300 cells per
microlitre.
Clinically
meaningful AAER reductions were also observed in the
tezepelumab-treated patients, compared to placebo, irrespective of
allergy status and fractional exhaled nitric oxide
level53. The NAVIGATOR Phase III trial will
form the basis of regulatory submissions for tezepelumab in severe
asthma in H1 2021.
Table 33: Key tezepelumab Phase III trials
|
Trial (population)
|
Design
|
Timeline
|
Status
|
|
NAVIGATOR
(severe
asthma)
|
Placebo
or tezepelumab 210mg
Q4W SC
|
FPCD:
Q1 2018
LPCD:
Q3 2019
|
Primary
endpoint met
Breakthrough
Therapy Designation (US)
|
|
WAYPOINT
(chronic
rhinosinusitis with nasal polyps)
|
Placebo
or tezepelumab 210mg
Q4W SC
|
First
data anticipated 2022+
|
Initiating
|
Table 34: Key PT027 Phase III trials
|
Trial
|
Design
|
Timeline
|
Status
|
|
TYREE
(asthma
with exercise induced broncho
constriction)
|
Placebo
or PT027 160/180 lg, single dose
|
FPCD:
Q1 2020
LPCD:
Q3 2020
|
Primary
endpoint met
|
|
MANDALA
(moderate
to severe asthma)
|
Albuterol
or PT027 80/180 lg or PT027 160/180 lg (all ‘as
needed’)
|
FPCD:
Q4 2018
First
data anticipated: H2 2021
|
Recruitment
ongoing
|
|
DENALI
(mild
to moderate asthma)
|
Placebo
or albuterol 180 lg or budesonide 160 lg or PT027 80/180 lg or
PT027 160/180 lg QID
|
FPCD:
Q2 2019
LPCD:
Q2 2021
First
data anticipated: H2 2021
|
Recruitment
completed
|
Other
a)
Nirsevimab (respiratory syncytial virus)
In
April 2021, AstraZeneca announced that the MELODY Phase III trial
for nirsevimab had met its primary endpoint of a statistically
significant reduction in the incidence of medically attended lower
respiratory tract infections caused by RSV compared to placebo in
healthy late preterm and term infants (35 weeks or more) during
their first RSV season. Nirsevimab becomes the first potential
immunisation to show protection against RSV in the general infant
population in a Phase III trial. Preliminary analysis of the safety
profile for nirsevimab was consistent with previous trial data. No
clinically meaningful differences in safety results between the
nirsevimab and placebo groups have been seen. The trial is ongoing
to collect additional safety data. Results from the MELODY trial
will be presented at a forthcoming medical meeting.
Nirsevimab
is also being evaluated in the MEDLEY Phase II/III trial which will
assess the safety and tolerability of nirsevimab compared to
Synagis (palivizumab) among
preterm infants and children with chronic lung disease (CLD) and
congenital heart disease (CHD) entering their first and second RSV
seasons. The MEDLEY trial is also expected to read out earlier with
first data anticipated in the second half of 2021. MELODY, MEDLEY
and the Phase IIb trial will form the basis of AstraZeneca's
regulatory submissions planned for 2022.
Table 35: Key nirsevimab trials
|
Trial
|
Design
|
Timeline
|
Status
|
|
MELODY
(healthy
late preterm and term infants)
|
Placebo
or nirsevimab IM
|
FPCD:
Q3 2019LPCD: Q3 2020
|
Primary
endpoint met
|
|
MEDLEY
(high-risk
children)
|
Synagis or nirsevimab IM
|
FPCD:
Q3 2019
LPCD:
Q4 2020
First
data anticipated
H2
2021
|
Recruitment
completed
|
COVID-19
a)
Pandemic COVID-19 vaccine
During
the period, AstraZeneca announced positive high-level results from
the US Phase III trial's primary analysis. The results confirmed
that vaccine efficacy was consistent with the previously announced
pre-specified interim analysis. The trial showed 76% (confidence
interval (CI): 68% to 82%) vaccine efficacy at preventing
symptomatic COVID-19, occurring 15 days or more after receiving two
doses given four weeks apart. Importantly, these results were
comparable across age groups, with vaccine efficacy of 85% (CI: 58%
to 95%) in adults 65 years and older. A key secondary endpoint,
preventing severe or critical disease and hospitalisation,
demonstrated 100% efficacy. In the coming weeks, the Company will
submit to the US FDA a regulatory submission for Emergency Use
Authorisation, incorporating data from both the US and non-US Phase
III clinical trial programme and emerging real-world
data.
In
March 2021, several regulatory agencies raised concerns about the
potential risk of rare thrombotic events in people administered
with the vaccine. Consequently, The Medicines and Healthcare
products Regulatory Agency in the UK and the European Medicines
Agency conducted several analyses that noted a potential causal
link between the vaccine and these events. The agencies, however,
reaffirmed that the vaccine's overall benefits continue to outweigh
the potential risks. AstraZeneca will continue to work closely with
health and regulatory authorities to ensure the appropriate use of
the vaccine.
Table 36: Key vaccine trials in COVID-19
|
Trial
|
Design
|
Timeline
|
Status
|
|
COV002
(UK), Phase II/III
(Protection
against COVID-19 in participants aged 18-55, 55+)
|
MenACWY
or COVID-19 vaccine
|
FPCD:
Q2 2020
LPCD:
Q4 2020
|
Initial
data readout
Regulatory authorisation (UK, EU)
|
|
COV003
(Brazil), Phase II/III
(Protection
against COVID-19 in participants aged 18-55)
|
MenACWY
or COVID-19 vaccine
|
FPCD:
Q2 2020
LPCD:
Q4 2020
|
Initial
data readout
Regulatory authorisation (UK, EU)
|
COV005
ChAdOx1 nCoV-19 ZA54 (South Africa), Phase I/II
(protection
against COVID-19 in participants aged 18-65
|
Placebo
or COVID-19 vaccine
|
FPCD:
Q2 2020
LPCD:
Q4 2020
|
Initial data readout
|
|
D8110C00001
(US,
global), Phase III
(protection
against
COVID-19
in participants aged 18+
|
Placebo
or COVID-19 vaccine
|
FPCD:
Q3 2020
LPCD:
Q1 2021
|
Initial
data readout
|
The
Company announced in
March 2021 a modification to the existing agreement with the US
Government to supply up to 500,000 additional doses of AZD7442, a
long-acting antibody (LAAB) combination. AZD7442 is a potential new
medicine in late-stage development for the prevention and treatment
of COVID-19. The value of the extended agreement is $205m. It is
contingent on AZD7442 receiving US FDA Emergency Use Authorisation
in preventing COVID-19 in people who have confirmed exposure to the
virus.
Total
potential US supplies of AZD7442 under this and prior agreements
with the US Government amount to 700,000; this includes 100,000
doses in 2020 and a further 600,000 doses in 2021.
Table 37: Key AZD7442 Phase II/III trials in COVID-19
|
Trial
|
Design
|
Timeline
|
Status
|
|
PROVENT
(protection
against COVID-19 (prophylaxis))
|
Placebo
|
FPCD:
Q4 2020
LPCD:
Q1 2021
First
data anticipated: H2 2021
|
Recruitment completed
|
|
STORM
CHASER
(protection
against
COVID-19
(post-exposure
prophylaxis))
|
Placebo
or
AZD7442 300mg IM
|
FPCD:
Q4 2020
LPCD:
Q1 2021
First
data anticipated: H1 2021
|
Recruitment completed
|
|
TACKLE
(COVID-19
(outpatient treatment))
|
Placebo
or
AZD7442 600mg IM
|
FPCD:
Q1 2021
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.
Interim Financial Statements
Table 38Error! No sequence specified.: Q1 2021 - Condensed consolidated statement of
comprehensive income
|
For the quarter ended 31 March
|
2021
|
2020
|
|
$m
|
$m
|
|
Total Revenue
|
7,320
|
6,354
|
|
Product Sales
|
7,257
|
6,311
|
|
Collaboration Revenue
|
63
|
43
|
|
Cost of Sales
|
(1,864)
|
(1,420)
|
|
Gross Profit
|
5,456
|
4,934
|
|
Distribution costs
|
(99)
|
(87)
|
|
Research and development expense
|
(1,713)
|
(1,388)
|
|
Selling, general and administrative costs
|
(2,929)
|
(2,719)
|
|
Other operating income and expense
|
1,180
|
480
|
|
Operating Profit
|
1,895
|
1,220
|
|
Finance income
|
20
|
51
|
|
Finance expense
|
(303)
|
(332)
|
|
Share of after-tax losses in associates and joint
ventures
|
(4)
|
(4)
|
|
Profit Before Tax
|
1,608
|
935
|
|
Taxation
|
(46)
|
(185)
|
|
Profit for the period
|
1,562
|
750
|
|
|
|
|
|
Other comprehensive income
|
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
|
Remeasurement of the defined benefit pension liability
|
481
|
440
|
|
Net (losses)/gains on equity investments measured at fair value
through other comprehensive income
|
(108)
|
171
|
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
1
|
21
|
|
Tax on items that will not be reclassified to profit or
loss
|
(94)
|
(66)
|
|
|
280
|
566
|
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
|
Foreign exchange arising on consolidation
|
(107)
|
(608)
|
|
Foreign exchange arising on designated borrowings in net investment
hedges
|
(302)
|
(380)
|
|
Fair value movements on cash flow hedges
|
(86)
|
(187)
|
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
121
|
45
|
|
Fair value movements on derivatives designated in net investment
hedges
|
13
|
60
|
|
Costs of hedging
|
(1)
|
(5)
|
|
Tax on items that may be reclassified subsequently to profit or
loss
|
26
|
73
|
|
|
(336)
|
(1,002)
|
|
Other comprehensive loss for the period, net of tax
|
(56)
|
(436)
|
|
Total comprehensive income for the period
|
1,506
|
314
|
|
|
|
|
|
Profit attributable to:
|
|
|
|
Owners of the Parent
|
1,561
|
780
|
|
Non-controlling interests
|
1
|
(30)
|
|
|
1,562
|
750
|
|
Total comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
1,506
|
345
|
|
Non-controlling interests
|
-
|
(31)
|
|
|
1,506
|
314
|
|
Basic earnings per $0.25 Ordinary Share
|
$1.19
|
$0.59
|
|
Diluted earnings per $0.25 Ordinary Share
|
$1.18
|
$0.59
|
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,312
|
1,312
|
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,319
|
1,313
|
Table 39: Condensed consolidated statement of financial
position
|
|
At 31 Mar 2021
|
At 31 Dec 2020
|
At 31 Mar 2020
|
|
$m
|
$m
|
$m
|
|
Assets
|
|
|
|
|
Non-current assets
|
|
|
|
|
Property, plant and equipment
|
8,189
|
8,251
|
7,347
|
|
Right-of-use assets
|
660
|
666
|
644
|
|
Goodwill
|
11,765
|
11,845
|
11,569
|
|
Intangible assets
|
20,347
|
20,947
|
19,718
|
|
Investments in associates and joint ventures
|
88
|
39
|
44
|
|
Other investments
|
972
|
1,108
|
1,476
|
|
Derivative financial instruments
|
115
|
171
|
104
|
|
Other receivables
|
549
|
720
|
527
|
|
Deferred tax assets
|
3,506
|
3,438
|
2,960
|
|
|
46,191
|
47,185
|
44,389
|
|
Current assets
|
|
|
|
|
Inventories
|
4,278
|
4,024
|
3,123
|
|
Trade and other receivables
|
6,281
|
7,022
|
5,080
|
|
Other investments
|
129
|
160
|
752
|
|
Derivative financial instruments
|
64
|
142
|
61
|
|
Income tax receivable
|
347
|
364
|
262
|
|
Cash and cash equivalents
|
7,636
|
7,832
|
3,413
|
|
Assets held for sale
|
-
|
-
|
131
|
|
|
18,735
|
19,544
|
12,822
|
|
Total assets
|
64,926
|
66,729
|
57,211
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
Current liabilities
|
|
|
|
|
Interest-bearing loans and borrowings
|
(2,042)
|
(2,194)
|
(2,289)
|
|
Lease liabilities
|
(216)
|
(192)
|
(181)
|
|
Trade and other payables
|
(17,370)
|
(15,785)
|
(12,633)
|
|
Derivative financial instruments
|
(16)
|
(33)
|
(31)
|
|
Provisions
|
(875)
|
(976)
|
(649)
|
|
Income tax payable
|
(994)
|
(1,127)
|
(1,260)
|
|
|
(21,513)
|
(20,307)
|
(17,043)
|
|
Non-current liabilities
|
|
|
|
|
Interest-bearing loans and borrowings
|
(17,410)
|
(17,505)
|
(15,634)
|
|
Lease liabilities
|
(464)
|
(489)
|
(472)
|
|
Derivative financial instruments
|
(1)
|
(2)
|
(188)
|
|
Deferred tax liabilities
|
(2,823)
|
(2,918)
|
(2,501)
|
|
Retirement benefit obligations
|
(2,545)
|
(3,202)
|
(2,129)
|
|
Provisions
|
(576)
|
(584)
|
(807)
|
|
Other payables
|
(5,148)
|
(6,084)
|
(6,221)
|
|
|
(28,967)
|
(30,784)
|
(27,952)
|
|
Total liabilities
|
(50,480)
|
(51,091)
|
(44,995)
|
|
Net assets
|
14,446
|
15,638
|
12,216
|
|
Equity
|
|
|
|
|
Capital and reserves attributable to equity holders of the
Parent
|
|
|
|
|
Share capital
|
328
|
328
|
328
|
|
Share premium account
|
7,976
|
7,971
|
7,946
|
|
Other reserves
|
2,037
|
2,024
|
2,056
|
|
Retained earnings
|
4,089
|
5,299
|
448
|
|
|
14,430
|
15,622
|
10,778
|
|
Non-controlling interests
|
16
|
16
|
1,438
|
|
Total equity
|
14,446
|
15,638
|
12,216
|
Table 40: Condensed consolidated statement of changes in
equity
|
|
Share capital
|
Share premium
account
|
Other reserves
|
Retained earnings
|
Total attributable to
owners of the parent
|
Non-controlling
interests
|
Total equity
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
|
At 1 Jan 2020
|
328
|
7,941
|
2,046
|
2,812
|
13,127
|
1,469
|
14,596
|
|
Profit
for the period
|
-
|
-
|
-
|
780
|
780
|
(30)
|
750
|
|
Other comprehensive loss
|
-
|
-
|
-
|
(435)
|
(435)
|
(1)
|
(436)
|
|
Transfer to other reserves
|
-
|
-
|
10
|
(10)
|
-
|
-
|
-
|
|
Transactions with owners:
|
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(2,489)
|
(2,489)
|
-
|
(2,489)
|
|
Issue of Ordinary Shares
|
-
|
5
|
-
|
-
|
5
|
-
|
5
|
|
Share-based payments charge for the period
|
-
|
-
|
-
|
53
|
53
|
-
|
53
|
|
Settlement of share plan awards
|
-
|
-
|
-
|
(263)
|
(263)
|
-
|
(263)
|
|
Net
movement
|
-
|
5
|
10
|
(2,364)
|
(2,349)
|
(31)
|
(2,380)
|
|
At 31 Mar 2020
|
328
|
7,946
|
2,056
|
448
|
10,778
|
1,438
|
12,216
|
|
At 1 Jan 2021
|
328
|
7,971
|
2,024
|
5,299
|
15,622
|
16
|
15,638
|
|
Profit
for the period
|
-
|
-
|
-
|
1,561
|
1,561
|
1
|
1,562
|
|
Other comprehensive loss
|
-
|
-
|
-
|
(55)
|
(55)
|
(1)
|
(56)
|
|
Transfer to other reserves
|
-
|
-
|
13
|
(13)
|
-
|
-
|
-
|
|
Transactions with owners:
|
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(2,490)
|
(2,490)
|
-
|
(2,490)
|
|
Issue of Ordinary Shares
|
-
|
5
|
-
|
-
|
5
|
-
|
5
|
|
Share-based payments charge for the period
|
-
|
-
|
-
|
82
|
82
|
-
|
82
|
|
Settlement of share plan awards
|
-
|
-
|
-
|
(295)
|
(295)
|
-
|
(295)
|
|
Net
movement
|
-
|
5
|
13
|
(1,210)
|
(1,192)
|
-
|
(1,192)
|
|
At 31 Mar 2021
|
328
|
7,976
|
2,037
|
4,089
|
14,430
|
16
|
14,446
|
Table 41: Condensed consolidated statement of cash
flows
|
For the quarter ended 31 March
|
2021
|
2020
|
|
$m
|
$m
|
|
Cash flows from operating activities
|
|
|
|
Profit Before Tax
|
1,608
|
935
|
|
Finance income and expense
|
283
|
281
|
|
Share of after-tax losses of associates and joint
ventures
|
4
|
4
|
|
Depreciation, amortisation and impairment
|
797
|
841
|
|
Decrease/(increase) in working capital and short-term
provisions
|
1,210
|
(445)
|
|
Gains on disposal of intangible assets
|
(310)
|
(358)
|
|
Gains on disposal of investments in associates and joint
ventures
|
(776)
|
-
|
|
Fair value movements on contingent consideration arising from
business combinations
|
-
|
(33)
|
|
Non-cash and other movements
|
(363)
|
(429)
|
|
Cash generated from operations
|
2,453
|
796
|
|
Interest paid
|
(187)
|
(180)
|
|
Tax paid
|
(332)
|
(477)
|
|
Net cash inflow from operating activities
|
1,934
|
139
|
|
Cash flows from investing activities
|
|
|
|
Payment of contingent consideration from business
combinations
|
(171)
|
(167)
|
|
Purchase of property, plant and equipment
|
(220)
|
(186)
|
|
Disposal of property, plant and equipment
|
4
|
-
|
|
Purchase of intangible assets
|
(249)
|
(190)
|
|
Disposal of intangible assets
|
418
|
365
|
|
Purchase of non-current asset investments
|
-
|
(115)
|
|
Disposal of non-current asset investments
|
-
|
184
|
|
Movement in short-term investments, fixed deposits and other
investing instruments
|
28
|
98
|
|
Payments to associates and joint ventures
|
(55)
|
(8)
|
|
Disposal of investments in associates and joint
ventures
|
776
|
-
|
|
Interest received
|
24
|
28
|
|
Net cash inflow from investing activities
|
555
|
9
|
|
Net cash inflow before financing activities
|
2,489
|
148
|
|
Cash flows from financing activities
|
|
|
|
Proceeds from issue of share capital
|
5
|
6
|
|
Repayment of loans
|
(4)
|
-
|
|
Dividends paid
|
(2,469)
|
(2,398)
|
|
Hedge contracts relating to dividend payments
|
(23)
|
(93)
|
|
Repayment of obligations under leases
|
(50)
|
(53)
|
|
Movement in short-term borrowings
|
(190)
|
176
|
|
Net cash outflow from financing activities
|
(2,731)
|
(2,362)
|
|
Net decrease in cash and cash equivalents in the
period
|
(242)
|
(2,214)
|
|
Cash and cash equivalents at the beginning of the
period
|
7,546
|
5,223
|
|
Exchange rate effects
|
(67)
|
(32)
|
|
Cash and cash equivalents at the end of the period
|
7,237
|
2,977
|
|
Cash and cash equivalents consist of:
|
|
|
|
Cash and cash equivalents
|
7,636
|
3,413
|
|
Overdrafts
|
(399)
|
(436)
|
|
|
7,237
|
2,977
|
Notes to the Interim Financial Statements
1)
Basis of preparation and accounting policies
These
unaudited Interim Financial Statements for the three months ended
31 March 2021 have been prepared in accordance with IAS 34
‘Interim Financial Reporting’ as issued by the
International Accounting Standards Board (IASB) and as adopted by
the UK and the EU. 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 Interim Financial Statements have
transitioned to UK-adopted international accounting standards from
financial periods beginning 1 January 2021.
The
unaudited Interim Financial Statements for the three months ended
31 March 2021 were approved by the Board of Directors for
publication on 30 April 2021.
The
annual financial statements of the Group are prepared in accordance
with IFRSs as issued by the IASB and as adopted by the UK and the
EU. Except as noted below, the Interim Financial Statements have
been prepared applying the accounting policies that were applied in
the preparation of the Group’s published consolidated
financial statements for the year ended 31 December
2020.
IFRS 9 and IFRS 7
The
replacement of benchmark interest rates, such as the London
Inter-bank Offered Rate (LIBOR) and other interbank offered rates
(IBORs) has been a priority for global regulators and is expected
to be largely completed in 2021, although some benchmark rates will
be continued to be published until mid-2023. To prepare for this,
the Group adopted the Phase 1 amendments to IFRS 9 ‘Financial
Instruments’ and IFRS 7 ‘Financial Instruments:
Disclosures’ in 2019 and has adopted the Phase 2 amendments
in 2021. 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.
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 working on moving to new benchmark rates
in 2021.
COVID-19
AstraZeneca
has assessed the impact of the uncertainty presented by the
COVID-19 pandemic on the Interim Financial Statements comprising
the financial results to 31 March 2021 and the financial position
as at 31 March 2021, specifically considering the impact on key
judgements and significant estimates as detailed on page 180 of the
Annual
Report and 20-F Information 2020 along with a several other
areas of elevated risk during the pandemic period.
A
detailed assessment has been performed, focussing on the following
areas:
-
recoverable value of goodwill, intangible assets and property,
plant and equipment
-
impact on key assumptions used to estimate contingent consideration
liabilities
-
key assumptions used in estimating the Group’s defined
benefit pension obligations
-
basis for estimating clinical trial accruals
-
key assumptions used in estimating rebates, chargebacks and returns
for US Product Sales
-
valuations of unlisted equity investments
-
expected credit losses associated with changes in credit risk
relating to trade and other receivables
-
net realisable value of inventories
-
fair value of certain financial instruments
-
recoverability of deferred tax assets
-
effectiveness of hedge relationships
There
were no material accounting impacts identified relating to the
above areas during the three-month period ended 31 March
2021.
The
Group will continue to monitor these areas of increased judgement,
estimation and risk for material changes.
Going concern
The
Group has considerable financial resources available. As at 31
March 2021, the Group had $11.8bn in financial resources (cash and
cash-equivalent balances of $7.6bn, $0.1bn 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 $2.3bn of borrowings due within one year).
Additionally, as at 31 March 2021, to support the financing of the
acquisition of Alexion, the Group has committed bank facilities
totalling $17.5bn, which are available unit at least December 2022.
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 March 2021.
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 Interim 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 2020.
Financial information
The
comparative figures for the financial year ended 31 December 2020
are not the Group’s statutory accounts for that financial
year. Those accounts have been reported on by the Group’s
auditors and have been delivered to the registrar of companies;
their report was (i) unqualified, (ii) did not include a reference
to any matters to which the auditors drew attention by way of
emphasis without qualifying their report, and (iii) did not contain
a statement under section 498(2) or (3) of the Companies Act
2006.
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 $55m
being recorded against an intangible asset during the three months
ended 31 March 2021 (Q1 2020: $117m). Net impairment charges in
respect of launched products and products in development were $nil
(Q1 2020: $84m) and $55m (Q1 2020: $33m) respectively. Impairments
recorded on products in development were a consequence of failed or
poor performing trials, with the individual assets being fully
impaired.
The
table below provides an analysis of Net Debt and a reconciliation
of Net Cash Flow to the movement in Net Debt. The Group monitors
Net Debt as part of its capital-management policy as described in
Note 27 of the Annual Report and Form
20-F Information 2020. Net Debt is a non-GAAP financial
measure.
Table 42: Net Debt
|
|
|
At
1 Jan 2021
|
Cash flow
|
Non-cash &
other
|
Exchange
movements
|
At
31 Mar 2021
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
|
Non-current instalments of loans
|
|
(17,505)
|
-
|
1
|
94
|
(17,410)
|
|
Non-current instalments of leases
|
|
(489)
|
-
|
17
|
8
|
(464)
|
|
Total long-term debt
|
|
(17,994)
|
-
|
18
|
102
|
(17,874)
|
|
Current instalments of loans
|
|
(1,536)
|
4
|
-
|
71
|
(1,461)
|
|
Current instalments of leases
|
|
(192)
|
54
|
(83)
|
5
|
(216)
|
|
Bank collateral
|
|
(288)
|
114
|
-
|
-
|
(174)
|
|
Other short-term borrowings excluding overdrafts
|
|
(84)
|
76
|
-
|
-
|
(8)
|
|
Overdraft
|
|
(286)
|
(119)
|
-
|
6
|
(399)
|
|
Total current debt
|
|
(2,386)
|
129
|
(83)
|
82
|
(2,258)
|
|
Gross borrowings
|
|
(20,380)
|
129
|
(65)
|
184
|
(20,132)
|
|
Net derivative financial instruments
|
|
278
|
23
|
(139)
|
-
|
162
|
|
Net borrowings
|
|
(20,102)
|
152
|
(204)
|
184
|
(19,970)
|
|
Cash and cash equivalents
|
|
7,832
|
(123)
|
-
|
(73)
|
7,636
|
|
Other investments - current
|
|
160
|
(28)
|
-
|
(3)
|
129
|
|
Cash and investments
|
|
7,992
|
(151)
|
-
|
(76)
|
7,765
|
|
Net Debt
|
|
(12,110)
|
1
|
(204)
|
108
|
(12,205)
|
Non-cash
movements in the period include fair-value adjustments under IFRS
9.
The
Group has agreements with some bank counterparties whereby the
parties agree to post cash collateral on financial derivatives, for
the benefit of the other, equivalent to the market valuation of the
derivative positions above a predetermined threshold. The carrying
value of such cash collateral held by the Group was $174m (Q1 2020:
$163m) and the carrying value of such cash collateral posted by the
Group was $13m (Q1 2020: $190m). Cash collateral posted by the
Group is presented within Cash and cash equivalents.
Other
investments - non-current are included within the balance of $972m
(31 December 2020: $1,108m) in the Condensed consolidated statement
of financial position. The equivalent GAAP measure to net debt is
‘liabilities arising from financing activities’, which
excludes the amounts for cash and overdrafts, other investments and
non-financing derivatives shown above and includes the Acerta
Pharma put option liability of $2,336m (31 December 2020: $2,297m),
$874m of which is shown in current other payables and $1,462m is
shown in non-current other payables. In April 2021, AstraZeneca
exercised its option to acquire the remaining 45% of shares in
Acerta, please refer to Note 6 for further
information.
Net
Debt increased by $95m in the year to date to $12,205m. Details of
the committed undrawn bank facilities are disclosed within the
going-concern section of Note 1.
During
the three months to 31 March 2021, 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).
As
detailed in the Group’s most recent annual financial
statements, the principal financial instruments consist of
derivative financial instruments, other investments, trade and
other receivables, cash and cash equivalents, trade and other
payables, lease liabilities and interest-bearing loans and
borrowings. There have been no changes of significance to the
categorisation or fair-value hierarchy classification of financial
instruments from those detailed in the Notes to the Group Financial
Statements in the Annual Report and Form
20-F Information 2020.
The
Group holds certain equity investments that are categorised as
Level 3 in the fair-value hierarchy and for which fair-value gains
of $nil (Q1 2020: $6m gain) have been recognised in the three
months ended 31 March 2021. 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 three months ended 31 March 2021 are Level 1
fair-value measurements.
Financial
instruments measured at fair value include $1,101m of other
investments, $5,712m held in money-market funds, $333m of loans
designated at fair value through profit or loss, $354m of loans
designated in a fair-value hedge relationship and $162m of
derivatives as at 31 March 2021. The total fair value of
interest-bearing loans and borrowings at 31 March 2021, which have
a carrying value of $20,132m in the Condensed consolidated
statement of financial position, was $22,437m.
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 43: Financial instruments - contingent
consideration
|
|
|
2021
|
2020
|
|
|
Diabetes alliance
|
Other
|
Total
|
Total
|
|
|
$m
|
$m
|
$m
|
$m
|
|
At 1 January
|
|
2,932
|
391
|
3,323
|
4,139
|
|
Settlements
|
|
(166)
|
(5)
|
(171)
|
(167)
|
|
Revaluations
|
|
-
|
-
|
-
|
(33)
|
|
Discount unwind
|
|
49
|
6
|
55
|
73
|
|
At 31 March
|
|
2,815
|
392
|
3,207
|
4,012
|
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 $2,815m (31 December 2020: $2,932m)
would increase/decline by $282m 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 2020 (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 first quarter of 2021 and to 30
April 2021
Patent
litigation
Enhertu
US patent proceedings
As
previously disclosed, in October 2020, Seagen Inc. (Seagen) filed a
complaint against Daiichi Sankyo Company, Limited 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 Company, Limited and
Daiichi Sankyo Inc. filed a complaint against Seagen in the US
District Court for the District of Delaware (the District Court)
seeking a declaratory judgment that plaintiffs do not infringe the
‘039 patent. In April 2021, the District Court stayed this
proceeding for up to 90 days.
Faslodex
Patent Proceedings outside the US
In
Japan, in April 2021, AstraZeneca received notice from the Japan
Patent Office that Sandoz K.K. filed a Request for Invalidation
Trial to seek invalidation of the Faslodex formulation patent.
AstraZeneca is considering its response.
Farxiga
US patent proceedings
As
previously disclosed, in 2018, in response to Paragraph IV notices,
AstraZeneca initiated ANDA litigation against Zydus Pharmaceuticals
(USA) Inc. (Zydus) in the US District Court for the District of
Delaware. In the complaint, AstraZeneca alleged that Zydus’
generic version of Farxiga,
if approved and marketed, would infringe patents listed in the FDA
Orange Book with reference to Farxiga. Proceedings are ongoing and
trial is scheduled for May 2021.
Patent proceedings outside the US
As
previously disclosed, in Canada, in January 2021, Sandoz Canada
Inc. served three Notices of Allegation on AstraZeneca alleging
invalidity and/or non-infringement of all three patents listed on
the Canadian Patent Register in relation to Forxiga. AstraZeneca commenced
litigation in response.
In
Canada, in February 2021, Teva Canada Limited. served a Notice of
Allegation on AstraZeneca alleging invalidity and/or
non-infringement of all three patents listed on the Canadian Patent
Register in relation to Forxiga. AstraZeneca commenced
litigation in response.
Onglyza
Patent proceedings outside the US
As
previously disclosed, in Canada, in November 2019, Sandoz Canada
Inc. sent a Notice of Allegation to AstraZeneca challenging the
validity of Canadian substance Patent No. 2402894 (expiry March
2021) (the ‘894 patent) and formulation Patent No. 2568391
(expiry May 2025) related to Onglyza. AstraZeneca commenced an
action in response related to the ‘894 patent in January
2020. A trial date is set for May 2022.
Roxadustat
US Patent Proceedings
In
April 2021, Akebia Therapeutics, Inc. and Otsuka America
Pharmaceutical, Inc. served AstraZeneca with a complaint seeking a
declaration of invalidity and noninfringement for several of
FibroGen method of use patents (U.S. Patent Nos. 8318703, 8466172,
8614204, 9920011, 8629131, 8604012, 8609646, 8604013, 10626090,
10894774, 10882827, and 10927081) related to HIF prolylhydroxylase
inhibitors. AstraZeneca is the exclusive licensee of FibroGen in
the United States. AstraZeneca is considering its
response.
Patent proceedings outside the US
As
previously disclosed, in Canada, in May 2018, Akebia Therapeutics,
Inc. filed an impeachment action in the Federal Court of Canada
alleging invalidity of several of FibroGen’s method of use
patents (Canadian Patent Nos. 2467689; 2468083; and 2526496)
related to HIF prolylhydroxylase inhibitors. AstraZeneca is the
exclusive licensee of FibroGen in Canada. AstraZeneca and FibroGen
were defending the action. The parties have settled the
action.
Symbicort
US patent proceedings
As
previously disclosed, in October 2018, AstraZeneca initiated ANDA
litigation against Mylan and subsequently against 3M Company (3M)
in the US District Court for the Northern District of West Virginia
(the District Court). In the action, AstraZeneca alleges that the
defendants’ generic versions of Symbicort, if approved and marketed,
would infringe various AstraZeneca patents. Mylan and 3M alleged
that their proposed generic medicines do not infringe the asserted
patents and/or that the asserted patents are invalid and/or
unenforceable. In July 2020, AstraZeneca added Kindeva Drug
Delivery L.P. (Kindeva) as a defendant in the case. In September
2020, Mylan, 3M and Kindeva stipulated to patent infringement to
the extent that the asserted patent claims are found to be valid
and enforceable, but reserved the right to seek a vacatur of the
stipulation if the U.S. Court of Appeals for the Federal Circuit
reverses or modifies the District Court’s claim construction.
In October 2020, following a stipulation by AstraZeneca, 3M and
Kindeva, 3M was dismissed from the action. In March 2021, the
District Court decided in favour of AstraZeneca and determined that
the asserted patent claims were not invalid or unenforceable. Mylan
and Kindeva have appealed to the United States Court of Appeals for
the Federal Circuit.
Product liability litigation
Byetta/Bydureon
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 Byetta and/or
Bydureon. The lawsuits
allege several types of injuries including pancreatic cancer and
thyroid 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
October and December 2020, the District Court and the California
Court jointly heard oral argument on renewed motions filed by
Defendants seeking summary judgment and dismissal of all claims
alleging pancreatic cancer. In March and April 2021, the District
Court and the California State Court respectively granted the
Defendants’ motions, and dismissed all cases alleging
pancreatic cancer with prejudice. The plaintiffs have provided
notice that they intend to appeal. The other claims pending in both
courts, including those alleging thyroid cancer, remains
pending.
Nexium and Losec/Prilosec
US proceedings
As
previously disclosed, in the US, AstraZeneca is defending various
lawsuits brought in federal and state courts involving multiple
plaintiffs claiming that they have been diagnosed with various
injuries following treatment with proton pump inhibitors (PPIs),
including Nexium and
Prilosec. The vast majority
of those lawsuits relate to allegations of kidney injuries. In
particular, in May 2017, counsel for a group of such plaintiffs
claiming that they have been diagnosed with kidney injuries filed a
motion with the Judicial Panel on Multidistrict Litigation (JPML)
seeking the transfer of any currently pending federal court cases
as well as any similar, subsequently filed cases to a coordinated
and consolidated pre-trial multidistrict litigation (MDL)
proceeding. In August 2017, the JPML granted the motion and
consolidated the pending federal court cases in an MDL proceeding
in federal court in New Jersey for pre-trial purposes. A trial in
the MDL has been rescheduled for January 2022. In addition to the
MDL cases, there are cases filed in several state courts around the
US; a trial in Delaware state court has been scheduled for February
2022.
In
addition, AstraZeneca has been defending lawsuits involving
allegations of gastric cancer following treatment with PPIs. All
but one of these claims is filed in the MDL. One claim is filed in
the US District Court for the Middle District of Louisiana, where
the court has rescheduled a trial for August 2022.
Commercial litigation
Ocimum
lawsuit
As
previously disclosed, in the US, in December 2017, AstraZeneca was
served with a complaint filed by Ocimum Biosciences, Ltd. (Ocimum)
in the Superior Court for the State of Delaware (the Delaware
Supreme Court) that alleged, among other things, breaches of
contractual obligations and misappropriation of trade secrets,
relating to a now terminated 2001 licensing agreement between
AstraZeneca and Gene Logic, Inc. (Gene Logic), the rights to which
Ocimum purports to have acquired from Gene Logic. In February 2021,
the Delaware Supreme court affirmed the grant of
AstraZeneca’s motion for summary judgment. This matter is now
concluded.
AZD1222
securities litigation
As
previously disclosed, 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
(pandemic COVID-19 vaccine), a potential recombinant adenovirus
vaccine for the prevention of COVID-19. In March 2021, motions for
consolidation of the pending lawsuits and appointment of a lead
plaintiff and its counsel were filed and remain
pending.
Alexion
shareholder litigation
In
March 2021, several shareholders of Alexion filed individual
lawsuits against Alexion, its management, and/or AstraZeneca and
affiliates in federal district court in New York. The complaints
generally allege that the preliminary registration statement filed
with the SEC on 19 February 2021, omitted certain allegedly
material information in connection with AstraZeneca’s
proposed acquisition of Alexion (the Acquisition), and one of the
complaints further alleges that the Alexion directors breached
their fiduciary duties in connection with the Acquisition and that
AstraZeneca and the other entity defendants aided and abetted the
alleged breaches.
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 (the State), 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. The Supreme Court
heard oral argument on AstraZeneca’s appeal in March 2021. In
April 2021, prior to a decision from the Supreme Court, the State
unilaterally moved to dismiss all of its claims with prejudice.
That motion remains pending.
US
340B litigations and proceedings
As
previously disclosed, AstraZeneca is involved in several matters
relating to its policy with regard to contract pharmacy recognition
under the 340B Drug Pricing Program in the US. 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 (ADR) 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. In February 2021, AstraZeneca
received a Civil Investigative Subpoena from the Attorney
General’s Office for the State of Vermont seeking documents
and information relating to AstraZeneca’s policy regarding
contract pharmacy recognition under the 340B Drug Pricing
Program.
European
Commission Claim Regarding AZD1222
In
April 2021, the European Commission (acting on behalf of the
European Union and its member states) initiated legal proceedings
against AstraZeneca AB in the Court of First Instance in Brussels.
The proceedings relate to an Advance Purchase Agreement (APA)
between the parties dated 27 August 2020 for the supply of AZD1222.
The allegations include claims that AstraZeneca has failed to meet
certain of its obligations under the APA and the Commission is
seeking, among other things, a Court order to compel AstraZeneca to
supply a specified number of doses before the end of the second
quarter of 2021.
In
April 2021, AstraZeneca exercised its option to acquire the
remaining 45% of shares in Acerta, following the final condition
for exercising the option being satisfied in November 2020 when
Calquence received EU
marketing authorisation. Following the exercise of the option,
payments to acquire the remaining outstanding shares of Acerta are
to be made in similar annual instalments in 2022, 2023 and 2024.
The associated cash flows will be disclosed as financing activities
within the Consolidated Statement of Cash Flows.
50 White blood cells
gather in the lining of the oesophagus.
|
7)
|
Table
44: Q1 2021 - Product Sales year-on-year analysis57
|
|
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
|
Oncology
|
2,981
|
19
|
15
|
762
|
7
|
4
|
1,193
|
23
|
575
|
29
|
17
|
451
|
20
|
14
|
|
Tagrisso
|
1,149
|
17
|
13
|
306
|
9
|
5
|
415
|
12
|
225
|
39
|
26
|
203
|
20
|
14
|
|
Imfinzi
|
556
|
20
|
17
|
58
|
74
|
69
|
292
|
2
|
109
|
46
|
32
|
97
|
43
|
35
|
|
Lynparza
|
543
|
37
|
33
|
87
|
54
|
54
|
253
|
28
|
149
|
46
|
33
|
54
|
29
|
22
|
|
Calquence
|
209
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
195
|
n/m
|
9
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
|
Koselugo
|
21
|
n/m
|
n/m
|
-
|
-
|
-
|
21
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Enhertu
|
1
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Zoladex*
|
221
|
(1)
|
(6)
|
136
|
(8)
|
(11)
|
5
|
n/m
|
37
|
6
|
(2)
|
43
|
11
|
4
|
|
Faslodex*
|
122
|
(26)
|
(30)
|
43
|
(12)
|
(13)
|
9
|
(60)
|
41
|
(35)
|
(41)
|
29
|
(6)
|
(10)
|
|
Iressa*
|
61
|
(21)
|
(26)
|
53
|
(15)
|
(20)
|
3
|
(22)
|
2
|
(70)
|
(72)
|
3
|
(47)
|
(50)
|
|
Arimidex*
|
44
|
(12)
|
(15)
|
36
|
(13)
|
(17)
|
-
|
-
|
1
|
34
|
34
|
7
|
(10)
|
(14)
|
|
Casodex*
|
42
|
-
|
(6)
|
33
|
-
|
(6)
|
-
|
-
|
1
|
(9)
|
(10)
|
8
|
-
|
6
|
|
Others
|
12
|
(12)
|
(12)
|
7
|
(10)
|
(11)
|
-
|
n/m
|
1
|
(14)
|
19
|
4
|
11
|
-
|
|
BioPharmaceuticals: CVRM
|
1,912
|
12
|
9
|
945
|
22
|
20
|
463
|
(6)
|
364
|
18
|
9
|
140
|
9
|
3
|
|
Farxiga
|
624
|
54
|
50
|
260
|
84
|
85
|
131
|
16
|
174
|
50
|
36
|
59
|
69
|
60
|
|
Brilinta
|
374
|
(8)
|
(11)
|
105
|
(22)
|
(23)
|
166
|
1
|
88
|
(6)
|
(14)
|
15
|
(5)
|
(12)
|
|
Bydureon
|
103
|
3
|
1
|
-
|
(62)
|
(53)
|
85
|
1
|
15
|
24
|
14
|
3
|
-
|
(12)
|
|
Onglyza
|
101
|
(28)
|
(31)
|
58
|
22
|
19
|
19
|
(72)
|
15
|
1
|
(8)
|
9
|
(19)
|
(23)
|
|
Byetta
|
16
|
(20)
|
(20)
|
4
|
35
|
50
|
8
|
(29)
|
2
|
(35)
|
(40)
|
2
|
(18)
|
(27)
|
|
Other diabetes
|
13
|
3
|
(1)
|
3
|
62
|
55
|
6
|
(24)
|
4
|
36
|
25
|
-
|
(34)
|
(42)
|
|
Lokelma
|
33
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
24
|
n/m
|
2
|
n/m
|
n/m
|
6
|
n/m
|
n/m
|
|
Roxadustat
|
39
|
n/m
|
n/m
|
39
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
n/m
|
n/m
|
|
Crestor*
|
274
|
(9)
|
(12)
|
189
|
(1)
|
(4)
|
22
|
(22)
|
21
|
(40)
|
(43)
|
42
|
(11)
|
(15)
|
|
Seloken/Toprol-XL*
|
250
|
41
|
36
|
244
|
47
|
42
|
-
|
(90)
|
3
|
(26)
|
(26)
|
3
|
(13)
|
(23)
|
|
Atacand*
|
34
|
(48)
|
(49)
|
5
|
(89)
|
(89)
|
2
|
(15)
|
27
|
n/m
|
n/m
|
-
|
(97)
|
n/m
|
|
Others
|
51
|
(13)
|
(16)
|
37
|
-
|
(5)
|
-
|
-
|
13
|
(28)
|
(27)
|
1
|
(67)
|
(69)
|
|
BioPharmaceuticals: Respiratory & Immunology
|
1,541
|
(1)
|
(5)
|
542
|
1
|
(4)
|
551
|
8
|
299
|
(7)
|
(15)
|
149
|
(17)
|
(22)
|
|
Symbicort
|
691
|
(13)
|
(15)
|
165
|
6
|
3
|
266
|
(14)
|
168
|
(14)
|
(21)
|
92
|
(29)
|
(33)
|
|
Pulmicort
|
330
|
(13)
|
(18)
|
286
|
(9)
|
(14)
|
17
|
(25)
|
16
|
(37)
|
(43)
|
11
|
(42)
|
(47)
|
|
Fasenra
|
260
|
31
|
27
|
3
|
(51)
|
(47)
|
156
|
30
|
63
|
37
|
25
|
38
|
40
|
33
|
|
Daliresp/Daxas
|
60
|
14
|
12
|
1
|
13
|
13
|
54
|
20
|
5
|
(35)
|
(47)
|
-
|
-
|
-
|
|
Bevespi
|
13
|
8
|
5
|
1
|
n/m
|
n/m
|
10
|
(15)
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
|
Breztri
|
27
|
n/m
|
n/m
|
9
|
n/m
|
n/m
|
12
|
n/m
|
1
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
|
Others
|
160
|
42
|
33
|
77
|
30
|
20
|
36
|
n/m
|
44
|
(4)
|
(12)
|
3
|
(38)
|
(40)
|
|
Other medicines
|
548
|
(2)
|
(5)
|
297
|
19
|
15
|
53
|
(39)
|
76
|
(38)
|
(40)
|
122
|
25
|
18
|
|
Nexium*
|
403
|
19
|
15
|
234
|
25
|
21
|
32
|
(20)
|
18
|
(18)
|
(26)
|
119
|
34
|
27
|
|
Synagis*
|
24
|
(72)
|
(72)
|
-
|
n/m
|
n/m
|
2
|
(75)
|
22
|
(69)
|
(69)
|
-
|
-
|
-
|
|
Seroquel XR/IR*
|
29
|
(20)
|
(22)
|
14
|
11
|
14
|
7
|
(46)
|
7
|
(3)
|
(8)
|
1
|
(66)
|
(89)
|
|
Losec/Prilosec*
|
54
|
1
|
(5)
|
46
|
6
|
(2)
|
-
|
n/m
|
8
|
64
|
69
|
-
|
(95)
|
(95)
|
|
FluMist*
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
n/m
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
|
Others
|
36
|
(19)
|
(20)
|
3
|
92
|
93
|
12
|
(51)
|
19
|
25
|
22
|
2
|
(37)
|
(40)
|
|
COVID-19
|
275
|
n/m
|
n/m
|
43
|
n/m
|
n/m
|
-
|
-
|
224
|
n/m
|
n/m
|
8
|
n/m
|
n/m
|
|
Pandemic COVID-19 vaccine
|
275
|
n/m
|
n/m
|
43
|
n/m
|
n/m
|
-
|
-
|
224
|
n/m
|
n/m
|
8
|
n/m
|
n/m
|
|
Total Product Sales
|
7,257
|
15
|
11
|
2,589
|
14
|
10
|
2,260
|
10
|
1,538
|
28
|
18
|
870
|
11
|
5
|
|
8)
|
Table
45: Q1 2021 - Product Sales quarterly sequential
analysis58
|
|
|
|
Actual
|
CER
|
|
|
$m
|
% change
|
% change
|
|
Oncology
|
2,981
|
3
|
1
|
|
Tagrisso
|
1,149
|
(1)
|
(3)
|
|
Imfinzi
|
556
|
-
|
(1)
|
|
Lynparza
|
543
|
9
|
8
|
|
Calquence
|
209
|
15
|
15
|
|
Koselugo
|
21
|
23
|
23
|
|
Enhertu
|
1
|
n/m
|
n/m
|
|
Zoladex*
|
221
|
2
|
-
|
|
Faslodex*
|
122
|
(6)
|
(8)
|
|
Iressa*
|
61
|
(9)
|
(11)
|
|
Arimidex*
|
44
|
22
|
18
|
|
Casodex*
|
42
|
7
|
5
|
|
Others
|
12
|
(4)
|
(6)
|
|
BioPharmaceuticals: CVRM
|
1,912
|
4
|
1
|
|
Farxiga
|
624
|
6
|
4
|
|
Brilinta
|
374
|
3
|
1
|
|
Bydureon
|
103
|
(16)
|
(17)
|
|
Onglyza
|
101
|
(3)
|
(6)
|
|
Byetta
|
16
|
(14)
|
(15)
|
|
Other diabetes
|
13
|
7
|
1
|
|
Lokelma
|
33
|
16
|
18
|
|
Roxadustat
|
39
|
n/m
|
n/m
|
|
Crestor*
|
274
|
(8)
|
(9)
|
|
Seloken/Toprol-XL*
|
250
|
25
|
21
|
|
Atacand*
|
34
|
(45)
|
(45)
|
|
Others
|
51
|
12
|
10
|
|
BioPharmaceuticals: Respiratory & Immunology
|
1,541
|
1
|
(1)
|
|
Symbicort
|
691
|
2
|
-
|
|
Pulmicort
|
330
|
(10)
|
(13)
|
|
Fasenra
|
260
|
(8)
|
(9)
|
|
Daliresp/Daxas
|
60
|
11
|
10
|
|
Bevespi
|
13
|
7
|
8
|
|
Breztri
|
27
|
n/m
|
n/m
|
|
Others
|
160
|
28
|
25
|
|
Other medicines
|
548
|
(25)
|
(26)
|
|
Nexium*
|
403
|
7
|
5
|
|
Synagis*
|
24
|
(69)
|
(69)
|
|
Seroquel XR/IR*
|
29
|
51
|
38
|
|
Losec/Prilosec*
|
54
|
39
|
36
|
|
FluMist*
|
2
|
(99)
|
(99)
|
|
Others
|
36
|
(6)
|
(4)
|
|
COVID-19
|
275
|
n/m
|
n/m
|
|
Pandemic COVID-19 vaccine
|
275
|
n/m
|
n/m
|
|
Total Product Sales
|
7,257
|
4
|
1
|
|
9)
|
Table 46: FY 2020 - Product Sales quarterly sequential
analysis59
|
|
|
Q1 2020
|
Q2 2020
|
Q3 2020
|
Q4 2020
|
|
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
Actual
|
CER
|
|
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
$m
|
% change
|
% change
|
|
Oncology
|
2,502
|
10
|
10
|
2,609
|
4
|
6
|
2,831
|
8
|
6
|
2,908
|
3
|
2
|
|
Tagrisso
|
982
|
11
|
11
|
1,034
|
5
|
7
|
1,155
|
12
|
9
|
1,157
|
-
|
(1)
|
|
Imfinzi
|
462
|
9
|
9
|
492
|
6
|
8
|
533
|
8
|
6
|
555
|
4
|
3
|
|
Lynparza
|
397
|
13
|
13
|
419
|
5
|
7
|
464
|
11
|
8
|
496
|
7
|
6
|
|
Calquence
|
88
|
58
|
58
|
107
|
21
|
23
|
145
|
36
|
35
|
182
|
25
|
25
|
|
Koselugo
|
-
|
-
|
-
|
7
|
n/m
|
n/m
|
13
|
75
|
75
|
17
|
34
|
34
|
|
Zoladex*
|
225
|
15
|
15
|
217
|
(3)
|
-
|
230
|
6
|
3
|
216
|
(6)
|
(7)
|
|
Faslodex*
|
166
|
-
|
-
|
146
|
(12)
|
(9)
|
138
|
(5)
|
(8)
|
130
|
(6)
|
(7)
|
|
Iressa*
|
77
|
(3)
|
(4)
|
70
|
(9)
|
(7)
|
54
|
(23)
|
(24)
|
67
|
24
|
19
|
|
Arimidex*
|
50
|
(1)
|
(2)
|
58
|
17
|
16
|
42
|
(28)
|
(27)
|
36
|
(14)
|
(16)
|
|
Casodex*
|
42
|
(2)
|
(3)
|
47
|
14
|
12
|
44
|
(7)
|
(8)
|
39
|
(11)
|
(14)
|
|
Others
|
13
|
(52)
|
(52)
|
12
|
(11)
|
(1)
|
13
|
4
|
3
|
13
|
2
|
2
|
|
BioPharmaceuticals: CVRM
|
1,701
|
(5)
|
(5)
|
1,759
|
3
|
6
|
1,794
|
2
|
-
|
1,842
|
3
|
1
|
|
Farxiga
|
405
|
(3)
|
(3)
|
443
|
9
|
13
|
525
|
19
|
16
|
586
|
11
|
10
|
|
Brilinta
|
408
|
(5)
|
(5)
|
437
|
7
|
9
|
385
|
(12)
|
(13)
|
363
|
(6)
|
(6)
|
|
Onglyza
|
141
|
8
|
8
|
115
|
(19)
|
(17)
|
110
|
(6)
|
(6)
|
105
|
(4)
|
(5)
|
|
Bydureon
|
100
|
(28)
|
(28)
|
116
|
16
|
17
|
109
|
(5)
|
(7)
|
122
|
12
|
11
|
|
Byetta
|
20
|
(24)
|
(24)
|
15
|
(28)
|
(28)
|
15
|
1
|
4
|
19
|
26
|
24
|
|
Other diabetes
|
13
|
(22)
|
(22)
|
10
|
(21)
|
(19)
|
11
|
9
|
6
|
12
|
11
|
15
|
|
Lokelma
|
11
|
42
|
42
|
17
|
56
|
58
|
21
|
22
|
26
|
28
|
37
|
28
|
|
Crestor*
|
301
|
2
|
1
|
281
|
(7)
|
(4)
|
300
|
7
|
5
|
298
|
(1)
|
(4)
|
|
Seloken/Toprol-XL*
|
177
|
(6)
|
(6)
|
218
|
23
|
27
|
225
|
4
|
3
|
200
|
(11)
|
(13)
|
|
Atacand*
|
66
|
11
|
12
|
59
|
(11)
|
(5)
|
54
|
(9)
|
(12)
|
63
|
16
|
14
|
|
Others
|
59
|
(21)
|
(22)
|
48
|
(18)
|
(16)
|
39
|
(19)
|
(22)
|
46
|
18
|
17
|
|
BioPharmaceuticals: Respiratory & Immunology
|
1,551
|
1
|
1
|
1,117
|
(28)
|
(26)
|
1,161
|
4
|
1
|
1,528
|
32
|
29
|
|
Symbicort
|
790
|
11
|
11
|
653
|
(17)
|
(15)
|
599
|
(8)
|
(11)
|
680
|
13
|
13
|
|
Pulmicort
|
380
|
(8)
|
(9)
|
97
|
(74)
|
(73)
|
151
|
56
|
49
|
368
|
n/m
|
n/m
|
|
Fasenra
|
199
|
(3)
|
(3)
|
227
|
14
|
15
|
240
|
5
|
4
|
283
|
18
|
17
|
|
Daliresp/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
|
|
Other medicines
|
557
|
(15)
|
(15)
|
563
|
1
|
4
|
734
|
30
|
27
|
733
|
-
|
(2)
|
|
Nexium*
|
338
|
(4)
|
(4)
|
377
|
12
|
14
|
401
|
6
|
4
|
377
|
(6)
|
(7)
|
|
Synagis*
|
85
|
35
|
35
|
90
|
6
|
7
|
118
|
31
|
29
|
78
|
(34)
|
(33)
|
|
FluMist*
|
-
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
116
|
n/m
|
n/m
|
179
|
55
|
50
|
|
Losec/Prilosec*
|
54
|
18
|
17
|
45
|
(15)
|
(15)
|
45
|
-
|
-
|
39
|
(15)
|
(18)
|
|
Seroquel XR/IR*
|
36
|
(12)
|
(12)
|
27
|
(26)
|
(23)
|
35
|
32
|
29
|
19
|
(45)
|
(42)
|
|
Others
|
44
|
(71)
|
(70)
|
24
|
(46)
|
(42)
|
19
|
(17)
|
(19)
|
41
|
n/m
|
n/m
|
|
Total Product Sales
|
6,311
|
1
|
1
|
6,048
|
(4)
|
(2)
|
6,520
|
8
|
6
|
7,011
|
8
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59 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.
Table 47:
Ongoing Collaboration Revenue
|
|
|
Q1 2021
|
Q1 2020
|
FY 2020
|
FY 2019
|
|
|
$m
|
$m
|
$m
|
$m
|
|
Lynparza: regulatory
milestones
|
|
-
|
-
|
160
|
60
|
|
Lynparza: sales
milestones
|
|
-
|
-
|
300
|
450
|
|
Lynparza/Koselugo: option payments
|
|
-
|
-
|
-
|
100
|
|
Crestor (Spain)
|
|
-
|
-
|
-
|
39
|
|
Enhertu: share of gross
profits
|
|
38
|
14
|
94
|
-
|
|
Roxadustat: share of gross profits
|
|
2
|
3
|
30
|
-
|
|
Royalty income
|
|
18
|
17
|
62
|
62
|
|
Other Collaboration Revenue
|
|
5
|
9
|
81
|
108
|
|
Total
|
|
63
|
43
|
727
|
819
|
Table 48: Other Operating Income and Expense
The
table below provides an analysis of Reported Other Operating Income
and Expense.
|
|
|
Q1 2021
|
Q1 2020
|
FY 2020
|
FY 2019
|
|
|
$m
|
$m
|
$m
|
$m
|
|
Divestment of Viela Bio, Inc. shareholding
|
|
776
|
-
|
-
|
-
|
|
Crestor (Europe ex UK &
Spain)
|
|
309
|
-
|
-
|
-
|
|
Hypertension medicines (ex-US, India and Japan)
|
|
-
|
350
|
350
|
-
|
|
Monetisation of an asset previously licensed
|
|
-
|
-
|
120
|
-
|
|
Brazikumab licence termination funding
|
|
26
|
-
|
107
|
-
|
|
Inderal, Tenormin, Seloken and Omepral (Japan)
|
|
-
|
-
|
51
|
-
|
|
Synagis (US)
|
|
-
|
-
|
-
|
515
|
|
Losec (ex-China, Japan, US and
Mexico)
|
|
-
|
-
|
-
|
243
|
|
Seroquel and Seroquel XR (US,
Canada, Europe and Russia)
|
|
-
|
-
|
-
|
213
|
|
Arimidex and
Casodex
(various
countries)
|
|
-
|
-
|
-
|
181
|
|
Nexium (Europe) and
Vimovo
(ex-US)
|
|
-
|
-
|
54
|
-
|
|
Atacand
|
|
-
|
-
|
400
|
-
|
|
Other
|
|
69
|
130
|
446
|
389
|
|
Total
|
|
1,180
|
480
|
1,528
|
1,541
|
Financial calendar and other shareholder information
|
Annual
general meeting
|
11 May
2021
|
|
Announcement of
half-year and second-quarter results
|
29 July
2021
|
|
Announcement of
year-to-date and third-quarter results
|
12
November 2021
|
|
Announcement of
full-year and fourth-quarter results (tentative)
|
10
February 2022
|
|
|
|
Dividends are
normally 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 first interim dividend for 2021, payable on 13
September 2021, will be 13 August 2021. The ex-dividend date will
be 12 August 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 Arimidex and Casodex,
owned by AstraZeneca or Juvisé (depending on
geography); Atacand and Atacand
Plus, owned by AstraZeneca or
Cheplapharm (depending on geography); Duaklir and Eklira, trademarks of Almirall,
S.A.; Enhertu, a trademark of Daiichi
Sankyo; Inderal and Tenormin, owned by AstraZeneca, Atnahs Pharma and Taiyo
Pharma Co. Ltd. (depending upon
geography); Losec and Omepral,
owned by AstraZeneca, Cheplapharm or Taiyo Pharma Co., Ltd
(depending on geography); Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd
(depending on geography); Synagis, owned by 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
|
Euroclear Sweden AB PO Box 191
SE-101 23 Stockholm
|
American Stock Transfer
6201 15th Avenue
Brooklyn
NY 11219
|
|
United Kingdom
|
United Kingdom
|
Sweden
|
United States
|
|
|
|
|
|
|
+44 (0) 20 3749 5000
|
0800 389 1580
|
+46 (0) 8 402 9000
|
+1 (888) 697 8018
|
|
|
+44 (0) 121 415 7033
|
|
+1 (718) 921 8137
|
|
|
|
|
db@astfinancial.com
|
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
completion of 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 filed a
registration statement on Form F-4 (the Registration Statement),
which has been declared effective by the United States Securities
and Exchange Commission (SEC), and which includes a document that
serves as a prospectus of the Group and a proxy statement of
Alexion (the proxy statement/prospectus). Alexion filed the proxy
statement/prospectus as a proxy statement and the Group filed the
proxy statement/prospectus as a prospectus with the SEC on 12 April
2021, 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 and other relevant
documents filed with the SEC when they become available, because
they will contain important information. 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 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, is set
forth in the proxy statement/prospectus filed with the SEC on 12
April 2021. Information about
the directors and executive officers of Alexion and their ownership
of Alexion shares is set forth in Alexion’s Annual Report on
Form 10-K/A, as previously filed with the SEC on 16 February 2021.
Free copies of these documents may be obtained as described in the
paragraphs above.
- End
of document -
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:
30 April
2021
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|