Respiratory & Immunology
Total
Revenue declined by 1% in the year to date (an increase of 1% at
CER) to $3,841m. The impact of reduced sales of Pulmicort amounted to 15 percentage
points of Total Revenue growth.
Table 4: Select Respiratory & Immunology medicine
performances
|
YTD 2020
|
Q3 2020
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Symbicort: Product
Sales
|
2,042
|
15
|
16
|
599
|
(2)
|
(2)
|
Fasenra: Product
Sales
|
666
|
34
|
34
|
240
|
19
|
18
|
Pulmicort: Product
Sales
|
628
|
(40)
|
(39)
|
151
|
(55)
|
(55)
|
Sales
of Pulmicort, of which the
majority were in China, were adversely impacted in the year to date
by the effects of COVID-19. Pulmicort sales in Emerging Markets
declined by 43% in the year to date (42% at CER) to $479m and by
60% in the third quarter (59% at CER) to $109m.
Emerging Markets
Emerging
Markets increased by 6% in the year to date (11% at CER) to
$6,466m, including:
-
A China increase of
9% (11% at CER) to $4,013m; the performance was adversely impacted
by the aforementioned effects of COVID-19 on sales of Pulmicort. Q3 2020 Total Revenue
increased by 6% to $1,354m
-
An ex-China
increase of 3% (10% at CER) to $2,453m. Q3 2020 Total Revenue
declined by 7% (an increase of 2% at CER) to $783m, partly driven
by the impact of divestments in prior periods
COVID-19
The
Company is managing a number of challenges from the ongoing
pandemic, including:
-
reduced levels of
patient screenings, diagnoses, testing and elective
procedures
-
less face-to-face
engagement with healthcare practitioners for commercial field-sales
teams
-
additional costs
and procedures related to COVID-19, such as facilities cleaning,
personal protective equipment and colleague testing. AstraZeneca is
dedicated to providing safe-working environments for colleagues and
suppliers
-
an increase in
Distribution Expense
-
an impact on
initiation, ongoing recruitment and follow-up in some clinical
trials, primarily in the early stage. It remains prudent to assume
that additional delays will arise as a consequence of the
pandemic
Despite
a delayed global recovery, AstraZeneca is well-placed to manage
these challenges. The unprecedented environment has also provided
multiple opportunities to explore more efficient ways of working,
which have the potential to provide long-term benefits to patients
and to the Company.
In
addition, AstraZeneca has mobilised research efforts to target the
SARS-CoV-2 virus, to provide protection to societies and
individuals against COVID-19 and to treat patients with severe
disease. Late-stage clinical trials of the recombinant adenovirus
vaccine candidate, AZD1222, are ongoing in a number of countries,
including the UK, Brazil, South Africa and the US. The European
Medicines Agency (EMA) announced in October 2020 that its Committee
for Medicinal Products for Human Use (CHMP) had started a rolling
review of data for AZD1222, the first COVID-19 vaccine to be
reviewed under these arrangements.
In the
same month, the Company advanced into two Phase III clinical trials
of AZD7442 to evaluate safety and efficacy in preventing infection,
with plans for further trials for the treatment of
COVID-19.
Further
details of the Company’s broad COVID-19 research and
development programme are shown in the research and
development section of this announcement. Details of
AstraZeneca’s potential vaccine and its work with governments
and other organisations can be found in the sustainability
section of this announcement.
Sustainability summary
Recent
developments and progress against the Company’s
sustainability priorities are reported below:
During
the period, AstraZeneca‘s Chief Executive Officer (CEO),
Pascal Soriot, signed a vaccines
pledge in collaboration with nine biopharmaceutical CEOs,
committing to the continued safety and well-being of vaccinated
individuals as the top priority in the development of the first
COVID-19 vaccines.
b)
Environmental protection
As part
of its Ambition Zero Carbon strategy, the Company announced it had
accelerated delivery of its renewable power-sourcing
targets, achieving 100% supply of certified renewable
imported power across all sites worldwide by the end of 2020, five
years ahead of its original RE100 (renewable energy) commitments;
along with switching to electric vehicles (EV100) and increasing
energy productivity (EP100) by 2025.
c)
Ethics and transparency
Highlighting
the Company’s continued commitment to transparency and
ethical conduct, a new Data and Artificial
Intelligence (AI) Ethics position statement was published
during the period to establish and make visible AstraZeneca’s
principles around this emerging field of practice.
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.
2.
Reported financial
measures are the financial results presented in accordance with
International Financial Reporting Standards (IFRS), as issued by
the International Accounting Standards Board and adopted by the EU.
The UK is in the process of establishing its post-Brexit
IFRS-adoption authority, which is expected to be operational later
in 2020, but for the current time, will follow the EU approval
process.
5.
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 Interim Financial Statements. See
the operating and financial review for a definition of Core
financial measures and a reconciliation of Core to Reported
financial measures.
6.
Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new medicines are pillars
in the three therapy areas of Oncology, Cardiovascular (CV), Renal
& Metabolism (CVRM), and Respiratory & Immunology and are
important platforms for future growth. The Total Revenue of
Enhertu and roxadustat in
the year to date entirely reflected Ongoing Collaboration
Revenue.
7.
New CVRM comprises
Brilinta, Renal and
Diabetes medicines.
8.
Coronavirus
disease; an infectious disease caused by a newly discovered
coronavirus.
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.
Merck & Co.,
Inc., Kenilworth, NJ, US, known as MSD outside the US and
Canada.
Table 5: Pipeline highlights
The
following table highlights significant developments in the
late-stage pipeline since the prior results
announcement:
Regulatory
approvals
|
- Imfinzi - ES-SCLC1 (EU, JP)
- Enhertu - gastric cancer (3rd line,
HER2+2) (JP)
- Forxiga - T2D3 CVOT4 (CN)
|
Regulatory
submission acceptances and/or submissions
|
- Tagrisso - adjuvant NSCLC15 (EGFRm6) (US, CN; Priority Reviews)
- Imfinzi - new, once every four weeks
(Q4W) dosing (US; Priority Review, EU; accelerated
assessment)
- Imfinzi - ES-SCLC (CN)
- Enhertu - gastric cancer (3rd line,
HER2+) (US; Priority Review)
- Brilinta - stroke (THALES)
(CN)
- Symbicort - mild asthma
(EU)
- anifrolumab - lupus
(SLE7) (US, EU)
|
Major
Phase III data readouts or other significant
developments
|
- Tagrisso - adjuvant NSCLC (EGFRm):
Breakthrough Therapy Designation8 (US)
- Lynparza - ovarian cancer (1st line,
HRD+) (PAOLA-1): positive opinion (EU)
- Lynparza - prostate cancer (2nd line,
BRCAm9): positive opinion (EU)
- Forxiga - HF10 CVOT: positive opinion
(EU)
- Farxiga - CKD11: Breakthrough Therapy Designation
(US)
- Fasenra - nasal polyps12: Phase III primary endpoints
met
- Trixeo - COPD13: positive opinion (EU)
|
Table 6: Pipeline - anticipated major news flow
Timing
|
News
flow
|
Q4 2020
|
- Tagrisso - adjuvant NSCLC (EGFRm):
regulatory submission (EU)
- Imfinzi - new Q4W dosing: regulatory
decision (US)
- Lynparza - ovarian cancer (1st line)
(PAOLA-1): regulatory decision (EU, JP)
- Lynparza - breast cancer (BRCAm):
regulatory decision (CN)
- Lynparza - prostate cancer (2nd line,
BRCAm): regulatory decision (EU)
- Enhertu - breast cancer (3rd line,
HER2+): regulatory decision (EU)
- Calquence - CLL14: regulatory decision (EU)
- Forxiga - HF CVOT: regulatory decision
(EU, JP)
- Farxiga - CKD: regulatory
submission
- Brilinta - stroke (THALES): regulatory
decision (US)
- roxadustat -
anaemia in CKD: regulatory decision (US)
- Symbicort - mild asthma: regulatory
decision (CN)
- Trixeo - COPD: regulatory decision
(EU)
- tezepelumab -
severe asthma: data readout
- anifrolumab - lupus
(SLE): regulatory submission (JP)
- AZD1222 -
SARS-CoV-2: data readout, regulatory submission
|
H1 2021
|
- Tagrisso - adjuvant NSCLC (EGFRm):
regulatory decision (US, CN)
- Imfinzi - new Q4W dosing: regulatory
decision (EU)
- Imfinzi - unresectable, Stage III NSCLC
(PACIFIC-2): data readout, regulatory submission
- Imfinzi - NSCLC (1st line) (PEARL):
data readout
- Imfinzi +/- treme15 - head & neck cancer (1st line):
data readout, regulatory submission
- Lynparza - pancreatic cancer (1st line,
BRCAm): regulatory decision (JP)
- Lynparza - prostate cancer (2nd line):
regulatory decision (JP)
- Lynparza - adjuvant breast cancer: data
readout
- Enhertu - gastric cancer (3rd line,
HER2+): regulatory decision (US)
- Calquence - CLL: regulatory decision
(JP)
- Calquence - CLL (2nd line) (ELEVATE
R/R): data readout, regulatory submission
- Koselugo - NF116 regulatory decision (EU)
- Forxiga - HF CVOT: regulatory decision
(CN)
- Brilique/Brilinta - CAD17/T2D CVOT: regulatory decision (EU, JP,
CN)
- Brilique - stroke (THALES): regulatory
decision (EU)
- Symbicort - mild asthma: regulatory
decision (EU)
- Fasenra - nasal polyps: regulatory
submission
- tezepelumab -
severe asthma: regulatory submission
- AZD7442 -
SARS-CoV-2: data readout, regulatory submission
|
H2 2021
|
- Imfinzi - ES-SCLC: regulatory decision
(CN)
- Imfinzi - NSCLC (1st line) (PEARL):
regulatory submission
- Imfinzi - adjuvant bladder cancer: data
readout
- Imfinzi - liver cancer (locoregional):
data readout, regulatory submission
- Imfinzi - biliary tract cancer: data
readout
- Imfinzi +/- treme - NSCLC (1st line)
(POSEIDON): data readout (OS18), regulatory submission
- Imfinzi +/- treme - liver cancer (1st
line): data readout, regulatory submission
- Lynparza - ovarian cancer (3rd line,
BRCAm): regulatory submission
- Lynparza - adjuvant breast cancer:
regulatory submission
- Lynparza - prostate cancer (1st line,
castration-resistant): data readout, regulatory
submission
- Enhertu - breast cancer (3rd line,
HER2+) (Phase III): data readout
- Enhertu - breast cancer (2nd line,
HER2+): data readout, regulatory submission
- Enhertu - breast cancer (HER2
low19): data readout
- Farxiga - HF (HFpEF20): data readout, regulatory
submission
- Brilinta - stroke (THALES): regulatory
decision (CN)
- PT027 - asthma:
data readout
- anifrolumab - lupus
(SLE): regulatory decision (US, EU)
|
Conference call
A
conference call and webcast for investors and analysts will begin
at 11:45am UK time today. Details can be accessed via astrazeneca.com.
Reporting calendar
The
Company intends to publish its full-year and fourth-quarter results
on Thursday, 11 February 2021.
AstraZeneca
AstraZeneca
(LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of diseases in three therapy areas - Oncology, CVRM, and
Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com
and follow the Company on Twitter @AstraZeneca.
Contacts
For
details on how to contact the Investor Relations Team, please
click
here. For Media contacts, click
here.
Operating and financial review
All
narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m),
unless stated otherwise. The performance shown in this announcement
covers the nine-month period to 30 September 2020 (the year to date
or YTD 2020) and the three-month period to 30 September 2020 (the
quarter, the third quarter or Q3 2020), compared to the nine-month
period to 30 September 2019 (YTD 2019) and the three-month period
to 30 September 2019 (Q3 2019) respectively, unless stated
otherwise.
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 alliance21, acquisition-related costs, which
include fair-value adjustments and the imputed finance charge
relating to contingent consideration on business combinations and
legal settlements
Details
on the nature of Core financial measures are provided on page 80 of
the Annual
Report and Form 20-F Information 2019. Reference should be
made to the Reconciliation of Reported to Core financial measures
table included in the
operating and financial review in this
announcement.
EBITDA
is defined as Reported Profit Before Tax after adding back Net
Finance Expense, results from Joint Ventures and Associates and
charges for Depreciation, Amortisation and Impairment. Reference
should be made to the Reconciliation of Reported Profit Before Tax
to EBITDA included in the financial performance
section of 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.
Table 7: Total Revenue by therapy area
Specialty-care
medicines comprise all Oncology medicines, Brilinta, Lokelma, roxadustat and Fasenra. At 53% of Total Revenue (YTD
2019: 47%), specialty-care medicines increased by 22% in the year
to date (23% at CER) to $10,148m.
|
YTD 2020
|
Q3 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
8,185
|
43
|
23
|
24
|
2,861
|
13
|
13
|
BioPharmaceuticals
|
7,291
|
38
|
3
|
5
|
2,350
|
(4)
|
(3)
|
- New CVRM
|
3,450
|
18
|
7
|
10
|
1,185
|
6
|
8
|
- Respiratory &
Immunology
|
3,841
|
20
|
(1)
|
1
|
1,165
|
(12)
|
(12)
|
Other
medicines
|
3,731
|
19
|
(6)
|
(4)
|
1,367
|
(5)
|
(3)
|
|
|
|
|
|
|
|
|
Total
|
19,207
|
100
|
8
|
10
|
6,578
|
3
|
3
|
Table 8: Top-ten medicines by Total Revenue
Medicine
|
Therapy Area
|
YTD 2020
|
Q3 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Tagrisso
|
Oncology
|
3,171
|
17
|
38
|
39
|
1,155
|
30
|
30
|
Symbicort
|
Respiratory & Immunology
|
2,042
|
11
|
15
|
16
|
599
|
(2)
|
(2)
|
Imfinzi
|
Oncology
|
1,487
|
8
|
42
|
43
|
533
|
29
|
29
|
Lynparza
|
Oncology
|
1,415
|
7
|
28
|
29
|
464
|
(12)
|
(12)
|
Farxiga
|
CVRM
|
1,377
|
7
|
22
|
26
|
527
|
32
|
35
|
Brilinta
|
CVRM
|
1,230
|
6
|
7
|
9
|
385
|
(7)
|
(7)
|
Nexium
|
Other medicines
|
1,140
|
6
|
(1)
|
1
|
409
|
7
|
8
|
Crestor
|
CVRM
|
884
|
5
|
(11)
|
(9)
|
301
|
(13)
|
(12)
|
Zoladex
|
Oncology
|
717
|
4
|
14
|
18
|
233
|
1
|
3
|
Fasenra
|
Respiratory & Immunology
|
666
|
3
|
34
|
34
|
240
|
19
|
18
|
|
|
|
|
|
|
|
|
|
Total
|
|
14,129
|
74
|
20
|
22
|
4,846
|
10
|
10
|
Table 9: Collaboration Revenue
Other Ongoing Collaboration Revenue included Zoladex, Farxiga, Eklira, Nexium OTC22 and other royalties. No Initial
Collaboration Revenue was recorded in the year to
date.
|
YTD 2020
|
Q3 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Lynparza: regulatory milestone
revenue
|
135
|
41
|
(48)
|
(48)
|
-
|
n/m
|
n/m
|
Enhertu: profit
share
|
63
|
19
|
n/m
|
n/m
|
27
|
n/m
|
n/m
|
Roxadustat: profit share
|
19
|
6
|
n/m
|
n/m
|
8
|
n/m
|
n/m
|
Other Collaboration Revenue
|
111
|
34
|
(23)
|
(23)
|
23
|
(69)
|
(69)
|
|
|
|
|
|
|
|
|
Total
|
328
|
100
|
(19)
|
(18)
|
58
|
(79)
|
(78)
|
Total Revenue
The
performance of the Company’s medicines is shown below, with a
geographical split of Product Sales shown in Note 7.
Table 10: Therapy area and medicine performance - YTD
2020
Product Sales:
therapy area
|
Medicine
|
YTD 2020
|
$m
|
% of total Product Sales
|
% change
|
Actual
|
CER
|
Oncology
|
Tagrisso
|
3,171
|
17
|
38
|
39
|
Imfinzi
|
1,487
|
8
|
42
|
43
|
Lynparza
|
1,280
|
7
|
51
|
53
|
Calquence
|
340
|
2
|
n/m
|
n/m
|
Koselugo
|
20
|
-
|
n/m
|
n/m
|
|
672
|
4
|
9
|
13
|
|
450
|
2
|
(38)
|
(37)
|
|
201
|
1
|
(41)
|
(40)
|
|
149
|
1
|
(14)
|
(11)
|
|
133
|
1
|
(16)
|
(14)
|
Others
|
39
|
-
|
(44)
|
(43)
|
Total Oncology
|
7,942
|
42
|
24
|
26
|
BioPharmaceuticals: CVRM
|
Farxiga
|
1,373
|
7
|
22
|
26
|
Brilinta
|
1,230
|
7
|
7
|
9
|
Onglyza
|
365
|
2
|
(8)
|
(6)
|
Bydureon
|
326
|
2
|
(21)
|
(20)
|
Byetta
|
50
|
-
|
(40)
|
(38)
|
Other diabetes
|
35
|
-
|
(4)
|
(4)
|
Lokelma
|
48
|
-
|
n/m
|
n/m
|
|
882
|
5
|
(10)
|
(8)
|
|
620
|
3
|
9
|
14
|
|
180
|
1
|
11
|
18
|
Others
|
145
|
1
|
(27)
|
(26)
|
BioPharmaceuticals:
total CVRM
|
5,254
|
28
|
3
|
5
|
BioPharmaceuticals: Respiratory & Immunology
|
Symbicort
|
2,042
|
11
|
15
|
16
|
Fasenra
|
666
|
4
|
34
|
34
|
Pulmicort
|
628
|
3
|
(40)
|
(39)
|
Daliresp/Daxas
|
163
|
1
|
4
|
4
|
Bevespi
|
36
|
-
|
19
|
19
|
Breztri
|
21
|
-
|
n/m
|
n/m
|
Others
|
273
|
1
|
(17)
|
(16)
|
BioPharmaceuticals: total Respiratory & Immunology
|
3,829
|
20
|
(1)
|
1
|
Other medicines
|
|
1,115
|
6
|
(1)
|
1
|
|
294
|
2
|
-
|
-
|
|
144
|
1
|
(34)
|
(32)
|
|
116
|
1
|
n/m
|
n/m
|
|
98
|
1
|
(35)
|
(34)
|
Others
|
87
|
-
|
(35)
|
(35)
|
Total other medicines
|
1,854
|
10
|
(5)
|
(4)
|
|
Total Product Sales
|
18,879
|
100
|
9
|
11
|
Total Collaboration Revenue
|
328
|
|
(19)
|
(18)
|
Total Revenue
|
19,207
|
|
8
|
10
|
Table 11: Therapy area and medicine performance - Q3
2020
Product Sales:
therapy area
|
Medicine
|
Q3 2020
|
$m
|
% of total Product Sales
|
% change
|
Actual
|
CER
|
Oncology
|
Tagrisso
|
1,155
|
18
|
30
|
30
|
Imfinzi
|
533
|
8
|
29
|
29
|
Lynparza
|
464
|
7
|
42
|
42
|
Calquence
|
145
|
2
|
n/m
|
n/m
|
Koselugo
|
13
|
-
|
n/m
|
n/m
|
Zoladex
|
230
|
4
|
2
|
3
|
Faslodex
|
138
|
2
|
(33)
|
(32)
|
Iressa
|
54
|
1
|
(41)
|
(40)
|
Arimidex
|
42
|
1
|
(34)
|
(32)
|
Casodex
|
44
|
1
|
(16)
|
(16)
|
Others
|
13
|
-
|
(37)
|
(34)
|
Total Oncology
|
2,831
|
43
|
21
|
22
|
BioPharmaceuticals: CVRM
|
Farxiga
|
525
|
8
|
32
|
35
|
Brilinta
|
385
|
6
|
(7)
|
(7)
|
Onglyza
|
109
|
2
|
(14)
|
(13)
|
Bydureon
|
110
|
2
|
(14)
|
(14)
|
Byetta
|
15
|
-
|
(46)
|
(44)
|
Other diabetes
|
11
|
-
|
(19)
|
(20)
|
Lokelma
|
21
|
-
|
n/m
|
n/m
|
Crestor
|
300
|
5
|
(11)
|
(10)
|
Seloken/Toprol-XL
|
225
|
3
|
27
|
32
|
Atacand
|
54
|
1
|
(2)
|
4
|
Others
|
39
|
1
|
(41)
|
(41)
|
BioPharmaceuticals:
total CVRM
|
1,794
|
28
|
3
|
4
|
BioPharmaceuticals: Respiratory & Immunology
|
Symbicort
|
599
|
9
|
(2)
|
(2)
|
Fasenra
|
240
|
4
|
19
|
18
|
Pulmicort
|
151
|
2
|
(55)
|
(55)
|
Daliresp/Daxas
|
57
|
1
|
8
|
9
|
Bevespi
|
14
|
-
|
38
|
36
|
Breztri
|
10
|
-
|
n/m
|
n/m
|
Others
|
90
|
1
|
(12)
|
(13)
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,161
|
18
|
(12)
|
(12)
|
Other medicines
|
Nexium
|
401
|
6
|
7
|
9
|
Synagis
|
118
|
2
|
(19)
|
(19)
|
Losec/Prilosec
|
45
|
1
|
(38)
|
(38)
|
FluMist
|
116
|
2
|
n/m
|
n/m
|
Seroquel XR/IR
|
35
|
1
|
(57)
|
(56)
|
Others
|
19
|
-
|
(56)
|
(57)
|
Total other medicines
|
734
|
11
|
1
|
1
|
|
Total Product Sales
|
6,520
|
100
|
6
|
7
|
|
Total Collaboration Revenue
|
58
|
|
(79)
|
(78)
|
|
Total Revenue
|
6,578
|
|
3
|
3
|
Total Revenue summary
Oncology
Total
Revenue of $8,185m in the year to date; an increase of 23% (24% at
CER). The performance of Enhertu was reflected entirely in
Collaboration Revenue.
Oncology
represented 43% of overall Total Revenue (YTD 2019:
38%).
Tagrisso
Tagrisso has received regulatory approval in 87 countries,
including the US, China, in the EU and Japan for the 1st-line
treatment of patients with EGFRm NSCLC. To date, reimbursement has
been granted in 32 countries in this setting, with further
reimbursement decisions anticipated. These developments followed
Tagrisso’s approval
in 89 countries, including the US, China, in the EU and Japan for
the treatment of patients with EGFR T790M24-mutation NSCLC, an indication in which
64 reimbursements have been obtained.
Total
Revenue, entirely comprising Product Sales, amounted to $3,171m in
the year to date and represented growth of 38% (39% at CER).
Sales in the US increased by 26% to
$1,144m.
In
Emerging Markets, Tagrisso
sales increased by 72% in the year to date (78% at CER) to $950m,
with notable growth in China, following the admission in 2019 to
the China National Reimbursement Drug List (NRDL) in the 2nd-line
setting. Japan increased by 12% (11% at CER) to $523m despite a Q4
2019 15% price reduction. In Europe, sales of $503m in the year to
date represented an increase of 49% (50% at CER), driven by use in
the 1st-line setting, as more reimbursements were
granted.
Imfinzi
Imfinzi has received regulatory approval in 65 countries,
including the US, China, in the EU and Japan for the treatment of
patients with unresectable, Stage III NSCLC whose disease has not
progressed following platinum-based chemoradiation therapy (CRT).
The number of reimbursements increased to 28 in the year to
date. Imfinzi has also been approved for the treatment of
ES-SCLC patients in 47 countries, with five reimbursements
obtained.
Total
Revenue, entirely comprising Product Sales, amounted to $1,487m in
the year to date and represented growth of 42% (43% at CER),
predominantly for the treatment of unresectable, Stage III NSCLC.
The US increased by 17% to $885m; in Japan, growth of 28% (27% at
CER) represented sales of $192m. Europe increased by 122% (125% at
CER) to $254m, reflecting a growing number of reimbursements while
Emerging Markets increased by 514% (543% at CER) to $113m,
following recent regulatory approvals and launches including in
China.
Lynparza
Lynparza has received regulatory approval in 77 countries
for the treatment of ovarian cancer; it has also been approved in
71 countries for the treatment of metastatic breast cancer, and in
51 countries for the treatment of
pancreatic cancer. Finally, it has also received regulatory
approval in 13 countries for the 2nd-line treatment of certain
prostate-cancer patients.
Product
Sales in the year to date amounted to $1,280m, reflecting growth of
51% (53% at CER). The strong performance was geographically spread,
with launches continuing globally. US Product Sales increased by
46% to $631m, as the launches in prostate cancer and 1st-line HRD+
ovarian cancer started to take effect. Lynparza continued to be the
leading medicine in the poly ADP ribose polymerase-inhibitor
(PARPi) class, as measured by total prescription volumes. Product
Sales in Europe increased by 50% (51% at CER) to $311m, reflecting
additional reimbursements and increasing BRCAm-testing rates, as
well as successful recent 1st-line BRCAm ovarian cancer launches,
including in the UK and Germany.
Japan
Product Sales of Lynparza amounted to $119m,
representing growth of 31% (30% at CER). Emerging Markets Product
Sales of $195m, up by 94% (105% at CER), were a result of the
regulatory approval of Lynparza as a 2nd-line maintenance
treatment of patients with ovarian cancer by the China National
Medical Products Administration (NMPA) in 2019. Lynparza was admitted to the China
NRDL for the same indication, with effect from January
2020.
Lynparza Total Revenue amounted to $1,415m in the year
to date and represented growth of 28% (29% at CER); this included
Collaboration Revenue of $135m. Collaboration Revenue receipts vary
quarter to quarter, with significant Lynparza receipts expected in the final
quarter of 2020.
Enhertu
US
sales, recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo),
amounted to $136m in the year to date, including $60m in the
quarter. Enhertu was approved by the US Food and Drug
Administration (FDA) for the treatment
of 3rd-line HER2+ breast cancer at the end of 2019. Total Revenue,
entirely comprising Collaboration Revenue recorded by AstraZeneca,
amounted to $63m in the year to date, with $27m in the
quarter.
Calquence
Total
Revenue, entirely comprising Product Sales, amounted to $340m in
the year to date and represented growth of 214%, with the
overwhelming majority of sales in the US. Calquence was approved by the US FDA
for the treatment of CLL in November 2019 and has received
regulatory approvals in this indication in an additional 16
countries. Calquence has
also received regulatory approvals in 20 countries for the
treatment of patients with mantle cell lymphoma.
Koselugo
Total
Revenue, entirely comprising Product Sales in the US, amounted to
$20m in the year to date, following its launch during the second
quarter of 2020 for the treatment of paediatric patients aged two
years and older with NF1 who have symptomatic, inoperable plexiform
neurofibromas.
Legacy: Zoladex
Total
Revenue, predominantly comprising Product Sales, amounted to $717m
in the year to date and represented growth of 14% (18% at
CER).
Emerging
Markets Product Sales of Zoladex increased by 12% (18% at CER)
to $427m, reflecting increased use and access in prostate cancer.
Product Sales in Europe increased by 5% (6% at CER) to $104m. In
the Established RoW region, Product Sales increased by 2% to
$135m.
Legacy: Faslodex
Total
Revenue, entirely comprising Product Sales, amounted to $450m in
the year to date and represented a decline of 38% (37% at
CER).
Emerging
Markets fell by 3% (up by 3% at CER) to $142m. US sales, however,
declined by 85% to $45m, reflecting the launch in 2019 of multiple
generic Faslodex medicines.
In Europe, where generic competitor medicines are established,
sales increased by 2% (3% at CER) to $171m, while in Japan, sales
fell by 11% (12% at CER) to $86m, driven by a mandated price
reduction in the second quarter of 2020.
Legacy: Iressa
Total
Revenue, entirely comprising Product Sales, amounted to $201m in
the year to date and represented a decline of 41% (40% at CER).
Emerging Markets fell by 28% (26% at CER) to $163m, driven by the
impact of Iressa’s
inclusion in China’s volume-based procurement (VBP) programme
and subsequent price reduction.
BioPharmaceuticals: CVRM
Total
Revenue increased by 3% in the year to date (5% at CER) to $5,278m
and represented 27% of Total Revenue (YTD 2019: 29%). This included
roxadustat Ongoing Collaboration Revenue of $19m, as well as sales
of Crestor and other legacy
medicines.
New
CVRM Total Revenue, which excludes sales of Crestor and other legacy medicines,
increased by 7% in the year to date (10% at CER) to $3,450m, mainly
reflecting the performances of Farxiga and, to a lesser extent,
Brilinta. New CVRM
represented 65% of overall CVRM Total Revenue in the year to date
(YTD 2019: 62%).
Farxiga
Total
Revenue, predominantly comprising Product Sales, amounted to
$1,377m in the year to date and represented growth of 22% (26% at
CER). Q3 2020 Total Revenue increased by 32% (35% at CER) to $527m,
reflecting growth across the regions.
Emerging
Markets Product Sales increased by 44% in the year to date (54% at
CER) to $488m. In China, Forxiga was admitted to the NRDL with
effect from the start of 2020; as expected, this adversely impacted
pricing. This effect, however, was more than offset by the volume
benefit derived from the launch within the NRDL listing. The
performance also reflected continued growth in the sodium-glucose
cotransporter 2 (SGLT2) inhibitor class at the expense of the
dipeptidyl-peptidase 4 (DPP-4) inhibitor class.
US
Product Sales declined by 3% to $385m in the year to date,
reflecting the impact of competitive activity on pricing and the
mix of channel sales that outweighed an encouraging level of volume
growth. There were, however, favourable movements in the share of
new-to-brand prescriptions, a result of a regulatory approval
update in Q3 2019 to reflect results from the DECLARE CVOT and the
more recent HFrEF (heart failure with reduced ejection fraction)
regulatory approval. US Product Sales in the quarter increased by
18% to $148m.
Product
Sales in Europe increased by 33% (34% at CER) in the year to date
to $363m, partly reflecting growth in the class and an acceleration
of new-to-brand prescriptions, following a similar DECLARE-trial
approval update. Product Sales in Europe in Q3 2020 increased by
48% (44% at CER) to $141m. In Japan, sales to the collaborator, Ono
Pharmaceutical Co., Ltd, which records in-market sales, increased
by 23% (22% at CER) to $77m.
Brilinta
Total
Revenue, entirely comprising Product Sales, amounted to $1,230m in
the year to date and represented growth of 7% (9% at CER). Patient
uptake continued in the treatment of acute coronary syndrome and
high-risk post-myocardial infarction (MI). Sales in Q3 2020,
however, declined by 7% to $385m due to a continued COVID-19 impact
and a wholesaler-inventory compensation in China following the VBP
announcement in August 2020.
Emerging
Markets sales increased by 13% (18% at CER) to $392m in the year to
date. Sales in the third quarter, however, declined by 22% (20% at
CER) to $102m, following announcement of the aforementioned VBP
update in China in August 2020, where AstraZeneca chose not to
compete on price, but still faced a mandatory price reduction of
30%, as per VBP rules. US sales, at $537m, represented an increase
of 7%, partly driven by a lengthening in the average-weighted
duration of treatment, resulting from the growing impact of 90-day
prescriptions. Sales of Brilique in Europe declined by 2% in
the year to date (1% at CER) to $257m, with sales adversely
impacted by COVID-19, reflecting fewer elective
procedures.
Onglyza
Total
Revenue, entirely comprising Product Sales, amounted to $365m in
the year to date and represented a decline of 8% (6% at CER). Total
Revenue in Q3 2020 decreased by 14% (13% at CER) to $109m,
following a declining market share.
Sales
in Emerging Markets increased by 18% (23% at CER) to $154m, driven
by the performance in China. US sales of Onglyza fell by 23% in the year to date
to $134m, while Europe sales declined by 19% to $43m, highlighting
the broader trend of a shift away from the DPP-4 inhibitor class.
Given the significant future potential of Farxiga, the Company continues to
prioritise commercial support over Onglyza.
Bydureon
Total
Revenue, entirely comprising Product Sales, amounted to $326m in
the year to date and represented a decline of 21% (20% at
CER).
US
sales of $278m reflected a decline of 18% in the year to date,
resulting from competitive pressures and the impact of managed
markets. Bydureon sales in
Europe fell by 24% (23% at CER) to $38m.
Lokelma
Total
Revenue, entirely comprising Product Sales, amounted to $48m in the
year to date (YTD 2019: $6m), with the US representing the
overwhelming majority; Lokelma continued to lead the
new-to-brand prescription market share in the US during the
period.
The
medicine has received regulatory approval in several markets,
including in the EU, China and Japan for the treatment of
hyperkalaemia, with further launches in several markets anticipated
soon.
Roxadustat
Total Revenue, entirely comprising Ongoing Collaboration Revenue,
amounted to $19m in the year to date in China. Q3 2020 revenue of
$8m reflected a sequential quarterly decline of 14%, predominantly
reflecting an accounting adjustment from the prior period. The
Company continued to focus on achieving hospital listings across
China, with more than 90,000 patients being treated for anaemia in
CKD with the medicine.
In July 2020, FibroGen Inc. (FibroGen) and AstraZeneca entered into
an amendment to revise the existing licence agreement for
roxadustat in China. From 2021, AstraZeneca is likely to recognise
the overwhelming majority of its future revenue in China as Product
Sales.
Legacy: Crestor
Total
Revenue, predominantly comprising Product Sales, amounted to $884m
in the year to date and represented a decline of 11% (9% at
CER).
Product
Sales in Emerging Markets fell by 10% (7% at CER) to $560m. The
performance was adversely impacted by the ongoing effects of the
aforementioned VBP programme in China. US Product Sales declined by
19% to $71m. In Europe, Product Sales fell by 16% (15% at CER) to
$94m while in Japan, where AstraZeneca collaborates with Shionogi
Co., Ltd, Product Sales declined by 4% (5% at CER) to
$121m.
BioPharmaceuticals: Respiratory & Immunology
Total
Revenue declined by 1% in the year to date (an increase of 1% at
CER) to $3,841m and represented 20% of Total Revenue (YTD 2019:
22%). This included Ongoing Collaboration Revenue of $12m from
Duaklir, Eklira and other medicines. Q3 2020
Total Revenue declined by 12% to $1,165m, largely as a result of
the aforementioned Pulmicort performance.
Symbicort
Total
Revenue, entirely comprising Product Sales, amounted to $2,042m in
the year to date and represented growth of 15% (16% at CER), a
result of the strong performance in the US. Q3 2020 Total Revenue
declined by 2% to $599m, driven by
stocking effects in the US and generic competition in Japan.
Symbicort remains the
global market-volume and value leader within the inhaled
corticosteroid (ICS) / long-acting beta agonist (LABA)
class.
US
sales grew by 29% to $755m in the year to date. An
authorised-generic version of Symbicort was launched in the US by the Company’s
collaborator, Prasco, in January 2020. Q3 2020 sales fell by 3% to
$197m, as a result of an unfavourable channel mix and the unwinding
of increased stocks from earlier in the year. Emerging Markets
sales increased by 6% in the year to date (11% at CER) to $423m,
reflecting positive performances in China and Russia.
In
Europe, sales increased by 3% in the year to date (4% at CER) to
$521m, with positive growth seen in France, Spain and Italy. In
Japan, sales increased by 10% (9% at CER) to $144m; Q3
2020 sales declined by 35% (36% at
CER) to $41m. This was driven by generic competition and an
unfavourable price and volume comparison versus Q3 2019, following
the termination of the Astellas Pharma Inc. co-promotion
agreement.
Pulmicort
Total
Revenue, entirely comprising Product Sales, amounted to $628m in
the year to date and represented a decline of 40% (39% at CER). Q3
2020 Total Revenue declined by 55% to $151m, as the continued effect of COVID-19
predominantly impacted the treatment of respiratory patients in the
hospital setting, particularly in
China.
Emerging
Markets, where Pulmicort
sales fell by 43% in the year to date (42% at CER) to $479m,
represented 76% of the global total. The performance in China was
impacted by COVID-19 with a reduction in the number of paediatric
patients attending outpatient nebulisation rooms. The volume of
adult elective procedures, where Pulmicort can be used in operative care
when oral corticosteroids (OCS) are unsuitable, partly recovered in
the quarter. Sales in the US declined by 40% to $53m, and also fell
in Europe by 8% (6% at CER) to $55m.
Fasenra
Fasenra has received regulatory approval in 59 countries,
including the US, in the EU and Japan for the treatment of patients
with severe, uncontrolled eosinophilic asthma. With further
regulatory reviews ongoing, Fasenra has already achieved
reimbursement in 45 countries.
Total
Revenue, entirely comprising Product Sales, amounted to $666m in
the year to date and represented growth of 34%. Q3 2020 Total
Revenue increased by 19% (18% at CER) to $240m, as a result of
positive market-share progression and
the increasing adoption of self-administration offsetting the
impact of COVID-19 on the level of new-patient starts in several
countries. Fasenra continued as the leading novel biologic in the
new-to-brand prescription segment for patients with severe
uncontrolled asthma in the majority of markets.
Sales
in the US increased by 23% in the year to date to $423m. Q3 2020 US
sales increased by 11% to $151m as a
result of sustained market-share growth. In Europe, sales of
$140m in the year to date represented an increase of 72% (74% at
CER), reflecting ongoing successful launches. Sales in Japan
increased by 16% (15% at CER) to $72m. In its approved indication
and among new patients. In Emerging Markets, sales amounted to $10m
in the year to date (YTD 2019: $4m).
Daliresp/Daxas
Total
Revenue, entirely comprising Product Sales, amounted to $163m in
the year to date and represented an increase of 4%. US sales,
representing 87% of the global total, increased by 6% to
$141m.
Bevespi
Total
Revenue, entirely comprising Product Sales, amounted to $36m in the
year to date and represented an increase of 19%. Bevespi has been launched in the US, in
a number of European countries and in Japan. Sales in the US
increased by 11% in the year to date to $33m.
Breztri
Total
Revenue, entirely comprising Product Sales, amounted to $21m in the
year to date (YTD 2019: $1m). Breztri has successfully launched in
China and in Japan for patients with COPD. Prescriptions in Japan
have been limited by Ryotanki, a regulation which limits
prescriptions to two weeks’ supply in the first year of
launch. On 1 October 2020, Ryotanki was lifted and the restriction
no longer applies. Breztri
was recently approved and launched in the US and received a
positive CHMP opinion in the EU, under the name Trixeo.
Broncho-Vaxom
In
September 2020, AstraZeneca signed a strategic collaboration
agreement with OM Pharma SA, through which the Company was granted
the exclusive right to import, distribute and promote the
immunological therapy Broncho-Vaxom (Bacterial Lysates/OM-85)
in China (excluding Hong Kong, Macau and Taiwan). Broncho-Vaxom can prevent and treat
recurrent or acute respiratory infections in patients by boosting
host immunity. In China, recurrent respiratory-tract infection is a
particularly common disease in children, with an incidence rate of
c.20%.
Other medicines (outside the three main therapy areas)
Total
Revenue, primarily comprising Product Sales, amounted to $1,903m in
the year to date, representing a decline of 7% (6% at CER). The
performance partly reflected the divestment of
global rights to Movantik, excluding Europe, Canada and
Israel, to RedHill Biopharma in April 2020. Other medicines Total Revenue
represented 10% of overall Total Revenue (YTD 2019:
11%).
Nexium
Total
Revenue, predominantly comprising Product Sales, amounted to
$1,140m in the year to date, representing a decline of 1% (an
increase of 1% at CER). Emerging Markets Product Sales of
Nexium fell by 2%
(increasing by 2% at CER) to $563m. In Japan, where AstraZeneca
collaborates with Daiichi Sankyo, Product Sales increased by 7% (6%
at CER) to $313m, while Product Sales in the US declined by 27% to
$127m and in Europe, the increase was 21% to $59m.
Losec/Prilosec
Total
Revenue, entirely comprising Product Sales, amounted to $144m in
the year to date, representing a decline of 34% (32% at CER),
partly reflecting the divestment of
global commercial rights, excluding China, Japan, the US and
Mexico, to Cheplapharm Arzneimittel GmbH (Cheplapharm) in October
2019. Emerging Markets fell by 18% (16% at CER) to $119m, with a
decline of 23% (24% at CER) to $38m in Q3 2020 as Losec was subject to a mandatory price
cut as part of the impact of aforementioned VBP programme in China;
sales in Europe fell by 63% to $17m in the year to
date.
FluMist
Total
Revenue, entirely comprising Product Sales, increased to $116m in
the year to date (YTD 2019: $20m) reflecting earlier delivery and
greater use of influenza vaccines. FluMist US sales increased to $65m in
the year to date (YTD 2019: $20m). Sales in Europe amounted to $49m
(YTD 2019: $nil).
Synagis
Total
Revenue of $294m in the year to date, entirely comprising Product
Sales, was stable. Sales in Europe, wholly reflecting sales to
AbbVie Inc (AbbVie) made under the current supply agreement for
markets outside the US, amounted to $247m in the year to date,
representing a decline of 5%; sales in Q3 2020 fell by 33% to $97m.
In the US, sales were $47m in the year to date, representing an
increase of 29%; this reflected a favourable gross-to-net
adjustment relating to prior periods.
The
commercial rights to the sale and distribution of Synagis outside the US, held by AbbVie
since 1997, will revert to AstraZeneca upon the expiry of the
current agreement on 30 June 2021. In general, the Company will
solely distribute and promote the medicine outside the US from 1
July 2021. The agreement with Swedish Orphan Biovitrum AB (publ),
for the rights to Synagis
in the US, was unaffected by this decision.
Regional Total Revenue
Table 12: Regional Total Revenue
|
YTD 2020
|
Q3 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Emerging
Markets
|
6,466
|
34
|
6
|
11
|
2,137
|
-
|
4
|
- China
|
4,013
|
21
|
9
|
11
|
1,354
|
6
|
6
|
- Ex-China
|
2,453
|
13
|
3
|
10
|
783
|
(7)
|
2
|
|
|
|
|
|
|
|
|
US
|
6,445
|
34
|
12
|
12
|
2,268
|
11
|
11
|
|
|
|
|
|
|
|
|
Europe
|
3,709
|
19
|
6
|
7
|
1,262
|
(9)
|
(11)
|
|
|
|
|
|
|
|
|
Established
RoW
|
2,587
|
13
|
7
|
7
|
911
|
7
|
7
|
- Japan
|
1,902
|
10
|
2
|
1
|
670
|
1
|
1
|
- Canada
|
459
|
2
|
33
|
36
|
161
|
34
|
37
|
- Other Est. RoW
|
226
|
1
|
7
|
12
|
80
|
17
|
14
|
|
|
|
|
|
|
|
|
Total
|
19,207
|
100
|
8
|
10
|
6,578
|
3
|
3
|
Europe
Total Revenue includes Product Sales that grew by 10% (8% at CER)
in the quarter and by 12% (13% at CER) in the YTD 2020. A
geographical split of Product Sales is shown in Note 7. For
additional details, refer to Table 45 for Collaboration Revenue
recognised during YTD 2020 and YTD 2019.
Table 13: Emerging Markets therapy-area performance - Total
Revenue
|
YTD 2020
|
Q3 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
2,238
|
35
|
34
|
40
|
777
|
26
|
30
|
BioPharmaceuticals
|
2,125
|
33
|
(6)
|
(1)
|
646
|
(17)
|
(13)
|
- New CVRM
|
1,072
|
17
|
28
|
35
|
353
|
13
|
19
|
- Respiratory &
Immunology
|
1,053
|
16
|
(26)
|
(23)
|
293
|
(37)
|
(35)
|
Other medicines
|
2,103
|
33
|
(3)
|
1
|
714
|
(3)
|
1
|
|
|
|
|
|
|
|
|
Total
|
6,466
|
100
|
6
|
11
|
2,137
|
-
|
4
|
Table 14: Notable new-medicine performances in Emerging Markets -
Total Revenue
|
YTD 2020
|
Q3 2020
|
$m
|
% of total
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Tagrisso
|
950
|
15
|
72
|
78
|
355
|
59
|
61
|
Forxiga
|
488
|
8
|
44
|
54
|
181
|
37
|
47
|
Brilinta
|
392
|
6
|
13
|
18
|
102
|
(22)
|
(20)
|
|
195
|
3
|
94
|
n/m
|
75
|
79
|
88
|
Emerging
Markets Total Revenue grew by 6% (11% at CER) to $6,466m in the
year to date. The new medicines represented 34% of Emerging Markets
Total Revenue (YTD 2019: 22%). Total Revenue from specialty-care
medicines increased by 32% (38% at CER) to $2,662m and comprised
41% of Emerging Markets sales in the year to date (YTD 2019: 33%).
In the third quarter, however, Total Revenue was stable (up by 4%
at CER) due to the continued effect of COVID-19 predominantly
impacting the treatment of respiratory patients in the hospital
setting.
China
Total Revenue comprised 62% of Emerging Markets Total Revenue in
the year to date and increased by 9% (11% at CER) to $4,013m. New
medicines, primarily driven by Tagrisso and Lynparza in Oncology and Forxiga in New CVRM, delivered
particularly encouraging growth and represented 33% of China Total
Revenue in the year to date (YTD 2019: 19%); strong sales of
Seloken, Zoladex and Symbicort supplemented this
performance. However, the aforementioned performance of
Pulmicort adversely
impacted Total Revenue. In the third quarter of 2020, Total Revenue
increased by 6% to $1,354m, with the performance reduced by sales
of Pulmicort and the
inclusion of Brilinta,
Losec and Arimidex in the VBP programme in Q3
2020, following the Company’s decision not to compete with
generic competitor price in the tender process,
respectively.
Ex-China
Emerging Markets Total Revenue, comprising entirely of Product
Sales, increased by 3% in the year to date (10% at CER) to $2,453m.
The new medicines represented 35% of ex-China Emerging Markets
Total Revenue (YTD 2019: 28%), increasing by 28% (39% at CER) to
$863m. In the third quarter of 2020, the performance reflected the
divestment of several medicines26 in Q4 2019 and Q1 2020, in the Middle
East and Africa, and the impact of lower demand in Brazil due to
COVID-19.
Table 15: Ex-China Emerging Markets: Total Revenue
|
YTD 2020
|
Q3 2020
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Ex-China Asia Pacific
|
896
|
5
|
7
|
299
|
4
|
7
|
Middle East and Africa
|
768
|
-
|
3
|
237
|
(15)
|
(12)
|
Ex-Brazil Latin America
|
317
|
-
|
16
|
110
|
2
|
20
|
Russia
|
237
|
34
|
45
|
62
|
(4)
|
8
|
Brazil
|
235
|
(14)
|
10
|
74
|
(27)
|
1
|
Table 16: Reported Profit and Loss - YTD 2020
|
YTD 2020
|
YTD 2019
|
% change
|
$m
|
$m
|
Actual
|
CER
|
Total Revenue
|
19,207
|
17,720
|
8
|
10
|
- Product
Sales
|
18,879
|
17,315
|
9
|
11
|
- Collaboration
Revenue
|
328
|
405
|
(19)
|
(18)
|
|
|
|
|
|
Cost of Sales
|
(3,774)
|
(3,543)
|
7
|
9
|
|
|
|
|
|
Gross Profit
|
15,433
|
14,177
|
9
|
10
|
Gross Profit Margin
|
80.0%
|
79.5%
|
-
|
-
|
|
|
|
|
|
Distribution Expense
|
(290)
|
(247)
|
17
|
21
|
% Total Revenue
|
1.5%
|
1.4%
|
-
|
-
|
R&D Expense
|
(4,272)
|
(3,968)
|
8
|
8
|
% Total Revenue
|
22.2%
|
22.4%
|
-
|
-
|
SG&A Expense
|
(8,084)
|
(8,656)
|
(7)
|
(5)
|
% Total Revenue
|
42.1%
|
48.9%
|
+7
|
+7
|
|
|
|
|
|
Other Operating Income & Expense
|
888
|
1,041
|
(15)
|
(14)
|
% Total Revenue
|
4.6%
|
5.9%
|
-1
|
-1
|
|
|
|
|
|
Operating Profit
|
3,675
|
2,347
|
57
|
59
|
Operating Profit Margin
|
19.1%
|
13.2%
|
+6
|
+6
|
|
|
|
|
|
Net Finance Expense
|
(905)
|
(948)
|
(5)
|
(5)
|
Joint Ventures and Associates
|
(21)
|
(91)
|
(76)
|
(75)
|
|
|
|
|
|
Profit Before Tax
|
2,749
|
1,308
|
n/m
|
n/m
|
|
|
|
|
|
Taxation
|
(610)
|
(358)
|
70
|
71
|
Tax Rate
|
22%
|
27%
|
|
|
|
|
|
|
|
Profit After Tax
|
2,139
|
950
|
n/m
|
n/m
|
|
|
|
|
|
EPS
|
$1.66
|
$0.79
|
n/m
|
n/m
|
Table 17: Reported Profit and Loss - Q3 2020
|
Q3 2020
|
Q3 2019
|
% change
|
$m
|
$m
|
Actual
|
CER
|
Total Revenue
|
6,578
|
6,406
|
3
|
3
|
- Product
Sales
|
6,520
|
6,132
|
6
|
7
|
- Collaboration
Revenue
|
58
|
274
|
(79)
|
(78)
|
|
|
|
|
|
Cost of Sales
|
(1,370)
|
(1,351)
|
1
|
-
|
|
|
|
|
|
Gross Profit
|
5,208
|
5,055
|
3
|
4
|
Gross Profit Margin
|
79.0%
|
78.0%
|
+1
|
+1
|
|
|
|
|
|
Distribution Expense
|
(99)
|
(88)
|
13
|
13
|
% Total Revenue
|
1.5%
|
1.4%
|
-
|
-
|
R&D Expense
|
(1,495)
|
(1,346)
|
11
|
11
|
% Total Revenue
|
22.7%
|
21.0%
|
-2
|
-2
|
SG&A Expense
|
(2,730)
|
(3,199)
|
(15)
|
(15)
|
% Total Revenue
|
41.5%
|
49.9%
|
+8
|
+9
|
|
|
|
|
|
Other Operating Income & Expense
|
287
|
335
|
(14)
|
(15)
|
% Total Revenue
|
4.4%
|
5.2%
|
-1
|
-1
|
|
|
|
|
|
Operating Profit
|
1,171
|
757
|
55
|
61
|
Operating Profit Margin
|
17.8%
|
11.8%
|
+6
|
+7
|
|
|
|
|
|
Net Finance Expense
|
(317)
|
(316)
|
1
|
(2)
|
Joint Ventures and Associates
|
(1)
|
(32)
|
(96)
|
(96)
|
|
|
|
|
|
Profit Before Tax
|
853
|
409
|
n/m
|
n/m
|
|
|
|
|
|
Taxation
|
(202)
|
(129)
|
57
|
63
|
Tax Rate
|
24%
|
32%
|
|
|
|
|
|
|
|
Profit After Tax
|
651
|
280
|
n/m
|
n/m
|
|
|
|
|
|
EPS
|
$0.49
|
$0.23
|
n/m
|
n/m
|
Table 18: Reconciliation of Reported Profit Before Tax to EBITDA -
YTD 2020
|
YTD 2020
|
YTD 2019
|
% change
|
$m
|
$m
|
Actual
|
CER
|
Reported Profit Before Tax
|
2,749
|
1,308
|
n/m
|
n/m
|
Net Finance Expense
|
905
|
948
|
(5)
|
(5)
|
Joint Ventures and Associates
|
21
|
91
|
(76)
|
(75)
|
Depreciation, Amortisation and Impairment
|
2,352
|
2,119
|
11
|
12
|
|
|
|
|
|
EBITDA
|
6,027
|
4,466
|
35
|
37
|
Table 19: Reconciliation of Reported Profit Before Tax to EBITDA -
Q3 2020
|
Q3 2020
|
Q3 2019
|
% change
|
$m
|
$m
|
Actual
|
CER
|
Reported Profit Before Tax
|
853
|
409
|
n/m
|
n/m
|
Net Finance Expense
|
317
|
316
|
1
|
(2)
|
Joint Ventures and Associates
|
1
|
32
|
(96)
|
(96)
|
Depreciation, Amortisation and Impairment
|
801
|
716
|
12
|
11
|
|
|
|
|
|
EBITDA
|
1,972
|
1,473
|
34
|
37
|
Table 20: Reconciliation of Reported to Core financial measures -
YTD 2020
YTD 2020
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Diabetes Alliance
|
Other
|
|
Core
% change
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross Profit
|
15,433
|
44
|
50
|
-
|
4
|
15,531
|
8
|
10
|
Gross Profit Margin
|
80.0%
|
|
|
|
|
80.5%
|
-
|
-
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(290)
|
-
|
-
|
-
|
-
|
(290)
|
17
|
21
|
R&D Expense
|
(4,272)
|
30
|
77
|
-
|
-
|
(4,165)
|
9
|
9
|
SG&A Expense
|
(8,084)
|
67
|
1,228
|
246
|
19
|
(6,524)
|
1
|
3
|
Total Operating Expense
|
(12,646)
|
97
|
1,305
|
246
|
19
|
(10,979)
|
4
|
5
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
888
|
(1)
|
2
|
-
|
-
|
889
|
(16)
|
(15)
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
3,675
|
140
|
1,357
|
246
|
23
|
5,441
|
11
|
13
|
Operating Profit Margin
|
19.1%
|
|
|
|
|
28.3%
|
+1
|
+1
|
|
|
|
|
|
|
|
|
|
Net Finance Expense
|
(905)
|
-
|
-
|
174
|
154
|
(577)
|
-
|
(2)
|
Taxation
|
(610)
|
(28)
|
(284)
|
(92)
|
(1)
|
(1,015)
|
11
|
13
|
|
|
|
|
|
|
|
|
|
EPS
|
$1.66
|
$0.09
|
$0.82
|
$0.25
|
$0.13
|
$2.95
|
13
|
16
|
Table 21: Reconciliation of Reported to Core financial measures -
Q3 2020
Q3 2020
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Diabetes Alliance
|
Other
|
|
Core
% change
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross Profit
|
5,208
|
9
|
17
|
-
|
(1)
|
5,233
|
2
|
3
|
Gross Profit Margin
|
79.0%
|
|
|
|
|
79.4%
|
-
|
-
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(99)
|
-
|
-
|
-
|
-
|
(99)
|
13
|
13
|
R&D Expense
|
(1,495)
|
14
|
28
|
-
|
-
|
(1,453)
|
10
|
10
|
SG&A Expense
|
(2,730)
|
22
|
419
|
94
|
24
|
(2,171)
|
(1)
|
(1)
|
Total Operating Expense
|
(4,324)
|
36
|
447
|
94
|
24
|
(3,723)
|
3
|
3
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
287
|
(3)
|
1
|
-
|
-
|
285
|
(19)
|
(20)
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
1,171
|
42
|
465
|
94
|
23
|
1,795
|
(4)
|
(1)
|
Operating Profit Margin
|
17.8%
|
|
|
|
|
27.3%
|
-2
|
-1
|
|
|
|
|
|
|
|
|
|
Net Finance Expense
|
(317)
|
-
|
-
|
59
|
50
|
(208)
|
10
|
8
|
Taxation
|
(202)
|
(8)
|
(101)
|
(32)
|
|
(343)
|
(10)
|
(7)
|
|
|
|
|
|
|
|
|
|
EPS
|
$0.49
|
$0.03
|
$0.28
|
$0.09
|
$0.05
|
$0.94
|
(4)
|
-
|
The
increases in Reported and Core Gross Profit in the year to date
reflected the growth in Product Sales. The Reported and Core Gross
Profit Margins were stable in the year to date at 80% and 81%,
respectively. A Core Gross
Profit Margin in the third quarter of 79% was also unchanged versus
the prior year.
b)
Total Operating Expense
Reported
Total Operating Expense declined by 2% in the year to date (1% at
CER) to $12,646m and represented 66% of Total Revenue (YTD 2019:
73%). Core Total Operating Expense increased by 4% (5% at CER) to
$10,979m and represented 57% of Total Revenue (YTD 2019:
59%).
-
The increase in
Reported and Core Distribution Expense in the year to date was a
result of adverse logistics impacts from the COVID-19
pandemic
-
The growth in
Reported and Core R&D Expense reflected investment in the
pipeline, including the development of datopotomab
deruxtecan and the
ending in 2019 of the release of the upfront funding of
Lynparza development, as
part of the aforementioned collaboration with MSD. There were
additional costs and procedures related to COVID-19, such as
personal protective equipment and colleague testing. AstraZeneca
has also mobilised research efforts to treat patients with severe
COVID-19 symptoms
-
The difference in
the movements of Reported and Core SG&A Expense partly
reflected fair-value adjustments arising on acquisition-related
liabilities, as well as an increase in legal provisions recognised
in 2019, offset by additional intangible asset impairment charges
recorded in the year to date. Within Core SG&A Expense,
pandemic-related savings partly compensated for investment in the
launches of new medicines and expansion in China.
c)
Other Operating Income and
Expense28
Reported
Other Operating Income and Expense in the year to date of $888m
reflected a decline of 15% (14% at CER). Core Other Operating
Income and Expense in the year to date, decreasing by 16% (15% at
CER) to $889m, included $350m of income from an agreement to
divest commercial rights to a number of legacy hypertension
medicines. Income was also received from the monetisation of an
asset previously licensed, as was a payment from Allergan (part of
AbbVie) of $51m in respect of the development of
brazikumab.
The
declines in Reported and Core Net Finance Expense partly reflected
a favourable movement in loan interest, following the repayment of
a $1bn bond in 2019.
The
Reported and Core Tax Rates for the year to date were 22% and 21%,
respectively (YTD 2019: 27% and 22%, respectively). The net cash
tax paid for the year to date was $1,221m, representing 44% of
Reported Profit Before Tax (YTD 2019: $965m, 74%); the increase
partly reflected the growth in Reported Profit Before Tax and the
phasing of tax payments.
f)
Non-controlling interests
Profit
attributable to non-controlling interests amounted to a loss of
$45m in the year to date (YTD 2019: $75m). This primarily reflected
the profit-sharing agreement with Acerta Pharma with regards to
Calquence.
Reported
EPS of $1.66 in the year to date represented an increase of 111%
(113% at CER); Core EPS increased by 13% (16% at CER) to
$2.95.
Table 22: Cash Flow
|
YTD 2020
|
YTD 2019
|
Change
|
$m
|
$m
|
$m
|
Reported Operating Profit
|
3,675
|
2,347
|
1,328
|
Depreciation, Amortisation and Impairment
|
2,352
|
2,119
|
233
|
|
|
|
|
Increase in Working Capital and Short-Term Provisions
|
(255)
|
(812)
|
557
|
Gains on Disposal of Intangible Assets
|
(535)
|
(833)
|
298
|
Non-Cash and Other Movements
|
(498)
|
313
|
(811)
|
Interest Paid
|
(517)
|
(575)
|
58
|
Taxation Paid
|
(1,221)
|
(965)
|
(256)
|
|
|
|
|
Net Cash Inflow from Operating Activities
|
3,001
|
1,594
|
1,407
|
|
|
|
|
Net Cash Inflow before Financing Activities
|
2,578
|
879
|
1,699
|
|
|
|
|
Net Cash Inflow/(Outflow) from Financing Activities
|
7
|
(1,771)
|
1,778
|
The
increase in Net Cash Inflow from Operating Activities in the year
to date primarily reflected an underlying improvement in business
performance. The increase in Non-Cash and Other Movements of $811m
to $498m was partly driven by a reduction in fair-value movements
on business combination-related liabilities and included the effect
of the re-acquisition of US rights to Duaklir/Tudorza from Circassia Pharmaceuticals
plc in settlement of a loan-receivable balance included in working
capital.
The
increase in Net Cash Inflow before Financing Activities was a
result of the aforementioned improvement in Net Cash Inflow from
Operating Activities, as well as a $1,103m increase in the Disposal
of Non-Current Asset Investments to $1,121m; AstraZeneca sold an
undisclosed proportion of its equity portfolio in the year to
date.
Recorded
within the Purchase of Intangible Assets, AstraZeneca made the
second of two $675m upfront payments in the second quarter of 2020
to Daiichi Sankyo, as part of the 2019 agreement on
Enhertu. The first of three
non-contingent payments were also made in the third quarter to
Daiichi Sankyo in respect of the potential new Oncology medicine,
datopotomab deruxtecan; the payment amounted to $350m.
Under
the terms of a past agreement to acquire Pearl Therapeutics Inc.,
AstraZeneca made a $150m milestone payment in the quarter upon the
US regulatory approval of Breztri for the treatment of COPD. This
was the final development and regulatory milestone under that
agreement. The cash payment of contingent consideration, in respect
of the former BMS share of the global diabetes alliance, amounted
to $394m in the year to date.
Capital Expenditure
Capital
expenditure amounted to $598m in the year to date, compared to
$659m in YTD 2019. This included investment in the new AstraZeneca
R&D centre on the Biomedical Campus in Cambridge,
UK.
Table 23: Net Debt summary
|
At 30 Sep 2020
|
At 31 Dec 2019
|
At 30 Sep 2019
|
$m
|
$m
|
$m
|
Cash
and cash equivalents
|
8,072
|
5,369
|
3,967
|
Other
investments
|
374
|
911
|
909
|
|
|
|
|
Cash and investments
|
8,446
|
6,280
|
4,876
|
|
|
|
|
Overdrafts
and short-term borrowings
|
(1,216)
|
(225)
|
(228)
|
Lease
liabilities
|
(666)
|
(675)
|
(712)
|
Current
instalments of loans
|
(2,186)
|
(1,597)
|
-
|
Non-current
instalments of loans
|
(18,271)
|
(15,730)
|
(17,218)
|
|
|
|
|
Interest-bearing loans and borrowings
(Gross Debt)
|
(22,339)
|
(18,227)
|
(18,158)
|
|
|
|
|
Net
derivatives
|
131
|
43
|
(16)
|
Net Debt
|
(13,762)
|
(11,904)
|
(13,298)
|
Net
Debt increased by $1,858m in the year to date, due principally to
Net Cash Inflow before Financing Activities of $2,578m being offset
by the payment of the second interim dividend of 2019 and first
interim dividend of 2020, totalling $3,572m.
Details
of the committed undrawn bank facilities are disclosed within the
going-concern section of Note 1. In August 2020, AstraZeneca issued
the following:
-
$1.2bn of
fixed-rate notes with a coupon of 0.700%, maturing in April
2026
-
$1.3bn of
fixed-rate notes with a coupon of 1.375%, maturing in August
2030
-
$0.5bn of
fixed-rate notes with a coupon of 2.125%, maturing in August
2050
In the
year to date, there have been no changes to the Company’s
credit ratings issued by Standard and Poor’s (long term:
BBB+, short term A-2) and Moody’s (long term: A3, short term
P-2).
Capital allocation
The
Board’s aim is to continue to strike a balance between the
interests of the business, financial creditors and the
Company’s shareholders. After providing for investment in the
business, supporting the progressive dividend policy and
maintaining a strong, investment-grade credit rating, the Board
will keep under review potential investment in immediately
earnings-accretive, value-enhancing opportunities.
Foreign exchange
The
Company’s transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies’ reporting currency.
Foreign-exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the
Company’s external dividend payments, paid principally in
pounds sterling and Swedish krona, are fully hedged from
announcement to payment date.
Table 24: Currency sensitivities
The
Company provides the following currency-sensitivity
information:
|
Average Exchange
Rates versus USD
|
|
Annual Impact of 5% Strengthening in Exchange Rate versus USD
($m)29
|
Currency
|
Primary Relevance
|
|
|
% change
|
Product Sales
|
Core Operating Profit
|
CNY
|
Product
Sales
|
6.92
|
7.00
|
(1)
|
288
|
190
|
EUR
|
Product
Sales
|
0.89
|
0.89
|
-
|
171
|
68
|
JPY
|
Product
Sales
|
108.98
|
107.51
|
1
|
139
|
98
|
|
|
|
|
|
231
|
123
|
|
|
|
|
|
|
|
GBP
|
Operating
Expense
|
0.78
|
0.79
|
-
|
27
|
(93)
|
SEK
|
Operating
Expense
|
9.46
|
9.40
|
1
|
5
|
(51)
|
AstraZeneca’s
sustainability approach has three priority areas33, aligned with the Company’s
purpose and business strategy:
-
Environmental
protection
-
Ethics and
transparency
Recent
developments and progress against the Company’s priorities
are reported below:
During
the period, AstraZeneca CEO Pascal Soriot signed a vaccines
pledge in collaboration with nine biopharmaceutical
companies, committing to the continued safety and well-being of
vaccinated individuals as the top priority in development of the
first COVID-19 vaccines. CEOs of AstraZeneca, BioNTech SE,
GlaxoSmithKline plc, Johnson & Johnson, Merck Inc., known as MSD outside the
United States and Canada, Moderna, Inc., Novavax, Inc., Pfizer Inc.
and Sanofi-aventis Groupe SA outlined a united commitment to uphold
the integrity of the scientific process as they work towards
potential global regulatory filings and approvals of the first
COVID-19 vaccines.
The
Company continues to work with governments and other organisations,
scaling up manufacturing with independent parallel supply chains
around the world to produce billions of doses to a consistent and
high standard of safety and efficacy. Several agreements have been
signed, covering the distribution of the potential vaccine, across
a number of countries and regions including the UK, US, the EU,
Russia, the Middle East, Latin America, Japan, China, Australia and
a wide group of low and middle-income countries. Across the world,
these parallel agreements have helped to provide total
manufacturing capacity approaching three billion doses of the
vaccine between now and the end of 2021. AstraZeneca is committed
to providing broad and equitable access to the potential vaccine on
a not-for-profit basis during the pandemic.
In
conjunction with the 75th (virtual) United Nations General
Assembly, the Company co-hosted a panel
event in partnership with Devex34, sharing lessons learnt and reflections
about partnering and achieving healthcare resilience in light of
health systems challenges brought to the fore by the COVID-19
pandemic. The Company also published an accompanying
thought-leadership article on
how to achieve a sustainable and resilient future in the context of
global health.
The
Company’s Healthy Heart Africa
programme marked its six-year anniversary in Kenya and
celebrated World Hypertension Day (17 October) with a social media
campaign highlighting its work in public-private
partnerships throughout Africa to support patient access to
hypertension care.
The
Young
Health Programme (YHP) and UNICEF partnership announced
Angola, Belize, Brazil, Indonesia, Jamaica and South Africa as the
six ‘accelerator’ countries that will lead a joint
initiative to promote healthier lifestyles and environments for
young people. The wider collaboration between YHP and UNICEF aims
to reach more than five million adolescents with non-communicable
disease (NCD) prevention messages and train more than 1,000 young
advocates to promote NCD prevention at local, national and
international levels, as well as positively shape policies and laws
around the world over the next five years.
b)
Environmental protection
During
the period, as part of its Ambition Zero
Carbon strategy, the Company announced it had
accelerated delivery of its renewable power sourcing
targets, achieving 100% supply of certified renewable
imported power across all sites worldwide by the end of 2020, five
years ahead of its original RE100 (renewable energy) commitments;
along with switching to electric vehicles (EV100) and increasing
energy productivity (EP100) in 2025.
As a
Gold Sponsor of Climate Week NYC (21-27 September 2020),
AstraZeneca participated in two virtual events; Katarina Ageborg,
Executive Vice President, Sustainability and Chief Compliance
Officer, took part in a panel for the Climate
Group focused on green economic recovery from COVID-19 and
was interviewed by The
Climate Group about the Company’s commitment to
sustainability and the threat climate change presents to public
health. The Company also led an expert panel
discussing the role of clean heat in industrial
decarbonisation and related challenges, chaired by Louise Nicholls,
AstraZeneca Sustainability Advisory Board member and former
Corporate Head of Human Rights, Food Sustainability and Food
Packaging, at Marks and Spencer plc. Recognising the need to think
beyond power in driving a clean-heat strategy, the Company
joined the
Renewable Thermal Collaborative (RTC) during the period in
support of its clean heat objectives as part of its Ambition Zero
Carbon commitments. RTC is the leading coalition for organisations
committed to decarbonising the energy required for heat in
buildings and industrial processes.
To
drive a more innovative framework for characterising the
environmental risks of active pharmaceutical ingredients the
IMI
PREMIER project was launched with AstraZeneca as the lead
organisation. The IMI is a public-private partnership between
pharmaceutical companies, the European Commission and the European
Federation of Pharmaceutical Industries and Associations. Supported
by the European Commission, the project benefits from €10m
investment to fund the research objectives.
During
the period, as part of the AZ Forest programme, the Company
announced a commitment to plant 20,000 trees in Australia in 2020,
as part of its 25 million tree long-term commitment in Australia.
AZ Forest is a global initiative to plant 50 million trees
worldwide by 2025. In partnership with local governments and One
Tree Planted, a non-profit organisation focused on global
reforestation, this initiative supports the World Economic
Forum’s ‘1T.org – The Champions for a Trillion
Trees’ platform.
c)
Ethics and transparency
During
the period, the Company held its first virtual Environmental,
Social and Corporate Governance (ESG) investor event, led by
Non-Executive Chairman of the Board, Leif Johansson and Katarina
Ageborg. ‘Meet AZN Management:
Leading in Sustainability’ virtual webcast shared
insights into the Company’s sustainability strategy and
governance and was attended by analysts, institutional investors
and ratings agencies, recognising the growing focus of the investor
community on ESG strategy as a guide to sustainable business
performance.
Highlighting
the Company’s continued commitment to transparency and
ethical conduct, a new Data and AI Ethics
position statement was published to establish and make
visible AstraZeneca’s principles around this emerging field
of practice.
During
the period, the Company launched the 2020 Code of Ethics awareness
training across its global employee base. Integrated into a broader
education and awareness campaign to mark Global Ethics Day
2020, the training takes a look at ethical decision making,
featuring inspiring stories from colleagues who are going above and
beyond what is required by regulation, to uphold the company
values.
As part
of the Company’s approach to sustainability strategy and
governance, the AstraZeneca Sustainability Advisory Board
participated in a virtual meeting during the period to discuss
current issues and future strategy. The advisory board comprises
five members of the Senior Executive Team and four external
sustainability experts, plus non-executive Board member Nazneen
Rahman.
For
more details on AstraZeneca’s sustainability ambition,
approach and targets, please refer to the latest Sustainability Report
2019 and Sustainability Data
Summary 2019. Additional information is available at
astrazeneca.com/sustainability.
As the
COVID-19 pandemic continues, the Company will evaluate the impact
on the initiation of clinical trials, ongoing recruitment and
follow-ups. It is prudent to assume that some delays will arise as
a consequence of the pandemic.
A
comprehensive breakdown of AstraZeneca’s pipeline of
medicines in human trials can be found in the latest
clinical-trials appendix, available on astrazeneca.com.
Highlights of developments in the Company’s late-stage
pipeline since the prior results announcement are shown
below:
Table 25: Late-stage pipeline
New
molecular entities and major lifecycle events for medicines in
Phase III trials or under regulatory review
|
20
|
Oncology
- Tagrisso - NSCLC
- Imfinzi - multiple cancers
- Lynparza - multiple
cancers
- Enhertu - multiple cancers
- capivasertib -
breast, prostate cancer
- Calquence - blood cancers
- tremelimumab -
multiple cancers
- monalizumab - head
& neck cancer
CVRM
- Farxiga - multiple
indications
- roxadustat -
anaemia in CKD
Respiratory & Immunology
- Fasenra - multiple
indications
- Breztri/Trixeo - COPD
- PT027 -
asthma
- tezepelumab -
severe asthma
- nirsevimab -
respiratory syncytial virus
- anifrolumab - lupus
(SLE)
- brazikumab -
inflammatory bowel disease
COVID-19
- AZD1222 -
SARS-CoV-2
- AZD7424 -
SARS-CoV-2
|
Total
projects
in
clinical development
|
148
|
|
Total
projects
in
total pipeline
|
172
|
|
Oncology
During
the period, AstraZeneca presented new developments at the European
Society for Medical Oncology (ESMO) Virtual Congress 2020.
AstraZeneca medicines and pipeline molecules featured in 114
abstracts at the congress, including 20 oral presentations and two
Presidential Symposia. The data highlight the breadth of the
portfolio of cancer medicines and the potential of the early-stage
pipeline
Oncology: lung cancer
During
the period, Tagrisso
received regulatory submission acceptance for its supplemental New
Drug Application and was also granted Priority Review in the US for
the adjuvant treatment of patients with early-stage (IB, II and
IIIA) EGFRm NSCLC after complete tumour resection with curative
intent. Tagrisso was also
granted Breakthrough Therapy Designation in the US for the same
treatment setting. In China, the regulatory submission was also
completed and granted priority review.
At the
aforementioned ESMO 2020 congress, Tagrisso results from a prespecified
exploratory analysis of the positive ADAURA Phase III trial were
presented during the Presidential Symposium and simultaneously
published alongside the primary results in The
New England Journal of Medicine. Tagrisso demonstrated a clinically
meaningful improvement in central nervous system (CNS) disease;
Tagrisso was given as
adjuvant treatment for patients with early-stage (IB, II and IIIA)
EGFRm NSCLC, after complete tumour resection. Tagrisso showed an 82% reduction in the
risk of CNS recurrence or death (based on a hazard ratio [HR] of
0.18; 95% confidence interval [CI] 0.10-0.33;
p<0.0001).
Table 26: Key Tagrisso
trials
Trial
|
Population
|
Design
|
Timeline
|
Status
|
Phase
III
NeoADAURA
|
Neo-adjuvant
EGFRm
NSCLC
|
Placebo
or Tagrisso
|
Q2
2020
First
data anticipated
2021+
|
Recruitment
ongoing
|
Phase
III
ADAURA
|
Adjuvant
EGFRm NSCLC
|
Placebo
or Tagrisso
|
FPCD
Q4
2015
Q1
2019
|
Trial
unblinded early due to overwhelming efficacy
|
Phase
III
LAURA
|
Locally
advanced, unresectable EGFRm NSCLC
|
Placebo
or Tagrisso
|
FPCD
Q4
2018
First
data anticipated
2021+
|
Recruitment
ongoing
|
Phase
III
FLAURA2
|
1st-line
EGFRm NSCLC
|
Tagrisso or Tagrisso
+ platinum-based chemotherapy doublet
|
FPCD
Q4
2019
First
data anticipated
2021+
|
Recruitment
ongoing
|
In
August 2020, Imfinzi
received regulatory submission acceptance for its supplemental
Biologics License Application (sBLA) and was also granted Priority
Review in the US for a new four-week, fixed-dose regimen. During
the period, Imfinzi was
granted accelerated assessment in the EU for the same indication.
If approved, Imfinzi could
be administered intravenously every four weeks at a fixed dose of
1,500mg, consistent with the approved dosing in
ES-SCLC.
During
the period, Imfinzi was
approved in the EU and Japan for the treatment of patients with
ES-SCLC, in combination with etoposide plus a choice of platinum
chemotherapy (either carboplatin or cisplatin). The approval was
based on positive results from the CASPIAN Phase III trial. In
China, the regulatory submission was also completed.
During
the aforementioned ESMO 2020 congress, updated results presented
from the Imfinzi PACIFIC
Phase III trial showed that Imfinzi demonstrated a sustained,
clinically meaningful OS and progression-free survival (PFS)
benefit in patients with unresectable, Stage III NSCLC who had not
progressed following concurrent CRT. The results from the updated
post-hoc analyses showed an estimated four-year OS rate of 49.6%
for Imfinzi, versus 36.3%
for placebo, after CRT.
Table 27: Key Imfinzi
trials in lung cancer
Trial
|
Population
|
Design
|
Timeline
|
Status
|
Phase
III
AEGEAN
|
Neo-adjuvant
(before surgery) NSCLC
|
SoC
chemotherapy +/- Imfinzi,
followed
by
surgery,
followed by placebo or Imfinzi
|
FPCD
Q1
2019
First
data anticipated
2021+
|
Recruitment
ongoing
|
Phase
III
|
Stage
Ib-IIIa resected NSCLC
|
Placebo or
Imfinzi
|
FPCD
Q1
2015
LPCD
Q1
2020
First
data anticipated
2021+
|
Recruitment
completed
|
Phase
III
MERMAID-1
|
Stage
II-III
resected
NSCLC
|
SoC
chemotherapy +/- Imfinzi
|
FPCDQ3
2020
First
data anticipated
2021+
|
Recruitmentongoing
|
Phase
III
PACIFIC-2
|
Stage
III unresectable locally advanced NSCLC
(concurrent
CRT)
|
Placebo or
Imfinzi
|
FPCD
Q2
2018
LPCD
Q3
2019
First
data anticipated
H1
2021
|
Recruitment
completed
|
Phase
III
ADRIATIC
|
Limited-
stage
SCLC
|
Concurrent
CRT,
followed
by
placebo
or
Imfinzi or Imfinzi +
treme
|
FPCD
Q4
2018
First
data anticipated
2021+
|
Recruitment
ongoing
|
Phase
III
PEARL
|
Stage
IV, 1st-line NSCLC
|
SoC
chemotherapy or Imfinzi
|
FPCD
Q1
2017
LPCD
Q1
2019
First
data anticipated
H1
2021
|
Recruitment
completed
|
Phase
III
POSEIDON
|
Stage
IV, 1st-line NSCLC
|
SoC
chemotherapy or SoC +
Imfinzi or SoC +
Imfinzi +
treme
|
FPCD
Q2
2017
LPCD
Q4
2018
OS data
anticipated
H2
2021
|
PFS
primary endpoint met
|
Phase
III
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
|
Table 28: Key Imfinzi
trials in tumour types other than lung cancer
Trial
|
Population
|
Design
|
Timeline
|
Status
|
Phase
III
POTOMAC
|
Non-muscle
invasive bladder cancer
|
SoC
BCG39 or SoC BCG + Imfinzi
|
FPCD
Q4
2018LPCDQ3 2020
First
data
anticipated
2021+
|
Recruitmentcompleted
|
Phase
III
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
H2
2021
|
Recruitment
ongoing
|
Phase
III
EMERALD-1
|
|
TACE41
followed by placebo or TACE + Imfinzi, followed by Imfinzi +
bevacizumab
or
TACE +
Imfinzi
followed
by Imfinzi
|
FPCD
Q1
2019
First
data
anticipated
H2
2021
|
Recruitment
ongoing
|
Phase
III
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
2021+
|
Recruitment
ongoing
|
Phase
III
CALLA
|
Locally
advanced cervical cancer
|
CRT or
CRT + Imfinzi, followed by
placebo or Imfinzi
|
FPCD
Q1
2019
LPCDQ4
2020
First
data anticipated
2021+
|
Recruitment
completed
|
Phase
III
|
Resectable
gastric
and gastroesophageal cancer
|
Chemotherapy
or chemotherapy +
Imfinzi
|
Initiating
|
Initiating
|
Phase
IIIKUNLUN
|
Locally
advanced, unresectable oesophageal squamous cell
carcinoma
|
Definitive
CRT or CRT + Imfinzi
|
FPCDQ4
2020First data anticipated2021+
|
Recruitmentongoing
|
Phase
III
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
2021+
|
Recruitment
ongoing
|
Phase
III
KESTREL
|
Stage
IV, 1st-line HNSCC42
|
SoC or
Imfinzi or Imfinzi + treme
|
FPCD
Q4
2015
LPCD
Q1
2017
First
data
anticipated
H1
2021
|
Recruitment
completed
|
Phase
III
HIMALAYA
|
Stage
IV, 1st-line unresectable HCC
|
Sorafenib or
Imfinzi or Imfinzi + treme
|
FPCD
Q4
2017
LPCD
Q4
2019
First
data
anticipated
H2
2021
|
Recruitment
completed
Orphan
Drug Designation (ODD)43 (US)
|
Phase
III
TOPAZ-1
|
Stage
IV, 1st-line biliary-tract cancer
|
Gemcitabine
and cisplatin SoC chemotherapy or SoC + Imfinzi
|
FPCD
Q2
2019
First
data anticipated
H2
2021
|
Recruitment
ongoing
|
c)
Lynparza
(multiple
cancers)
At the
aforementioned ESMO congress, data from the SOLO-1 Phase III trial
in ovarian cancer were presented, where Lynparza demonstrated a long-term PFS
benefit versus placebo as a 1st-line maintenance treatment in
patients with newly diagnosed, advanced BRCAm ovarian cancer who
had a complete or partial response following platinum-based
chemotherapy. Five-year follow-up data from the SOLO-1 trial showed
Lynparza reduced the risk
of disease progression or death by 67% (based on a HR of 0.33; 95%
CI 0.25-0.43) and improved PFS to a median of 56.0 months, versus
13.8 months for placebo.
At the
ESMO congress, final results from the Lynparza prostate PROfound Phase III
trial were also presented, which demonstrated a statistically
significant and clinically meaningful improvement in OS, versus
enzalutamide or abiraterone, in men with 2nd-line mCRPC and BRCA1/2
or ATM gene mutations, a subpopulation of HRR gene mutations. In
the key secondary endpoint of OS, Lynparza reduced the risk of death by
31%, versus enzalutamide or abiraterone (based on a HR of 0.69; 95%
CI 0.50-0.97; p=0.0175), despite 66% of men on new hormonal agent
treatments having crossed over to receive treatment with
Lynparza, following disease
progression.
Table 29: Key Lynparza
trials
Trial
|
Population
|
Design
|
Timeline
|
Status
|
Phase
III
OlympiA
|
Adjuvant
BRCAm breast cancer
|
SoC
placebo or Lynparza
|
FPCD
Q2
2014
LPCD
Q2
2019
First
data anticipated
H1
2021
|
Recruitment
completed
|
Phase
III
PROfound
|
Metastatic
castration-resistant 2nd-line+ HRRm
prostate
cancer
|
SoC
(abiraterone or enzalutamide) or Lynparza
|
FPCD
Q2
2017
LPCD
Q4
2018
|
Primary
endpoint met
Priority
Review (US)
|
Phase
III
|
Advanced
1st-line
ovarian
cancer
|
Bevacizumab
maintenance or
bevacizumab
+
Lynparza maintenance
|
FPCD
Q2
2015
LPCD
Q2
2018
|
Primary
endpoint met
Priority
Review (US)
|
Phase
II/III
GY005
|
Recurrent
platinum-resistant/refractory ovarian cancer
|
SoC
chemotherapy or cediranib or cediranib + Lynparza
|
FPCD
Q2
2016
(Phase
II)
FPCD
Q1
2019
(Phase
III)
First
data
anticipated
2021+
|
Recruitment
ongoing
(Phase
III component)
|
Phase
III
DuO-O
|
Advanced
1st-line
ovarian
cancer
|
Chemotherapy
+
bevacizumab
or
chemotherapy
+
bevacizumab
+
Imfinzi +/-
Lynparza maintenance
|
FPCD
Q1 2019
First
data
anticipated
2021+
|
Recruitment
ongoing
|
Phase
III
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
2021+
|
Recruitment
ongoing
|
Phase
III
PROpel
|
Stage
IV, advanced, castration-resistant prostate cancer
|
Abiraterone
or
abiraterone
+
Lynparza
|
FPCD
Q4
2018
First
data
anticipated
H2
2021
|
Recruitment
ongoing
|
Phase
III
LYNK-003
|
Stage
IV, 1st-line colorectal cancer
|
Bevacizumab
+ 5-FU45 maintenance or bevacizumab +
Lynparza maintenance or
Lynparza
maintenance
|
First
data
anticipated
2021+
|
Initiating
|
During
the period, Centus Biotherapeutics, a joint venture between
Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca, announced
that the European Commission had granted the marketing
authorisation for Equidacent (FKB238), the
company’s biosimilar to Avastin (bevacizumab). Bevacizumab is
an often-used medicine for the treatment of ovarian cancer,
including in combination with Lynparza. AstraZeneca continues to
prioritise the development of Lynparza and other innovative
medicines.
d)
Enhertu
(breast and other
cancers)
During
the period, Daiichi Sankyo announced the regulatory approval of
Enhertu in Japan for the
treatment of patients with HER2+ unresectable advanced or recurrent
gastric cancer that have progressed after chemotherapy.
Enhertu was previously
granted SAKIGAKE46 designation in Japan for this
indication. Regulatory submission acceptance and for an sBLA was also received in the US for Enhertu for the treatment of patients with HER2+,
metastatic gastric or gastroesophageal junction adenocarcinoma and
a Priority Review was also granted.
Table 30: Key Enhertu
trials
Trial
|
Population
|
Design
|
Timeline
|
Status
|
Phase
II
DESTINY-Breast01-U201
|
Stage
IV, HER2+47 breast cancer post trastuzumab
emtansine
|
Enhertu
|
FPCD
Q4
2017
LPCD
Q4
2018
|
Primary
objective met
Breakthrough
Therapy Designation (US)
|
Phase
III
DESTINY-Breast02-U301
|
Stage
IV, HER2+ breast cancer post trastuzumab emtansine
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2018
First
data anticipated
H2
2021
|
Recruitment ongoing
|
Phase
III
DESTINY-Breast03-U302
|
Stage
IV, HER2+ breast cancer
|
Trastuzumab
emtansine or Enhertu
|
FPCD
Q4
2018LPCDQ2 2020
First
data anticipated
H2
2021
|
Recruitment completed
|
Phase
III
DESTINY-Breast04
|
Stage
IV, HER2-low breast cancer
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2018
First
data anticipated
H2
2021
|
Recruitment ongoing
|
Phase
III
DESTINY-Breast06
|
Stage
IV, HER2-low breast cancer post endocrine therapy
|
SoC
chemotherapy or Enhertu
|
FPCDQ3
2020
|
Recruitment
ongoing
|
Phase
II
DESTINY-Gastric01
|
Stage
IV, HER2+ gastric cancer
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2017
LPCD
Q2
2019
|
Primary
endpoint met
Breakthrough
Therapy Designation
(US)
|
Phase
IIDESTINY-Gastric03
|
Stage
IV, HER2+ gastric cancer
|
SoC
chemotherapy or SoC + Enhertu
|
FPCDQ2
2020
|
Recruitmentongoing
|
Phase
II
DESTINY-PanTumour02
|
HER2
expressing tumours
|
Enhertu
|
FPCD
Q3
2020
|
Recruitment
ongoing
|
CVRM
AstraZeneca recently presented full data from the DAPA-CKD Phase
III trial at the European Society of Cardiology (ESC) Congress. The
data were among 20 abstracts presented by the Company at the
congress, showing the breadth of its CV, renal and metabolic
pipeline.
In October 2020, AstraZeneca presented 84 abstracts,
including 12 oral presentations and three late-breaking abstracts,
across its renal portfolio which includes roxadustat, Farxiga and Lokelma, at the American Society of
Nephrology (ASN) Kidney Week 2020 Reimagined.
In October 2020, the Company announced that the China NMPA had
approved an update to the label for Forxiga to include the positive CV outcomes and renal data
from the DECLARE-TIMI 58 Phase III trial in adults with
T2D.
b)
Farxiga
(heart
failure)
In October 2020, the Company announced that the CHMP had adopted a
positive opinion for an indication extension of Forxiga’s marketing authorisation in the EU for the
treatment of symptomatic chronic HFrEF with in adults with and
without T2D.
During
the period, the Company obtained results from the
DETERMINE-preserved and DETERMINE-reduced function and symptom
trials, evaluating Farxiga as a treatment for HFpEF and HFrEF,
respectively. These trials had the same primary endpoints. In the
DETERMINE-reduced trial, Farxiga demonstrated a statistically
significant reduction in HF symptoms, as measured by the Kansas
City Cardiomyopathy Questionnaire (KCCQ)-Total Symptom Score,
versus placebo. This trial did not, however, show a change from
baseline in the distance walked in six minutes, and the
KCCQ-Physical Limitation Score. The DETERMINE HFpEF trial did not
meet any of the three aforementioned endpoints. No new safety
concerns were identified. These results had no impact on
Farxiga’s HFrEF indication, which is approved in the US and
is under regulatory review in other regions, based on
ground-breaking data from the DAPA-HF trial. The large randomised
DELIVER Phase III trial, evaluating Farxiga in HFpEF, is expected
to read out in the second half of 2021.
Phase III trial data, presented at the aforementioned ESC Congress,
showed that Farxiga, on top of SoC, reduced the composite measure of
worsening of renal function or risk of CV or renal death by 39%,
compared to placebo (p<0.0001), in patients with CKD Stages 2-4
and elevated urinary albumin excretion. The absolute risk
reduction (ARR) was 5.3% over the median time in study of 2.4
years. The trial also met all secondary endpoints, including
significantly reducing death from any cause by 31% (ARR = 2.1%,
p=0.0035) compared to placebo. The
results were consistent in patients both with and without
T2D.
In October 2020, the Company announced that Farxiga had been granted US FDA Breakthrough Therapy
Designation for the treatment of patients with CKD, with and
without T2D.
d)
Forxiga
(type-1
diabetes)
During
the period, the European Commission renewed the licence of
Edistride (Forxiga in other EU markets) for the
treatment of T2D. The indication for type-1 diabetes (T1D) will,
however, be withdrawn. Edistride 5mg was approved for the
treatment of adults with insufficiently controlled T1D mellitus, as
an adjunct to insulin in patients with a Body Mass Index
≥27kg/m2, when insulin alone did not provide adequate
glycaemic control, despite optimal insulin therapy. Edistride is marketed only in Spain and
Portugal, where the T2D indication will continue to be available
for patients.
During
the period, the Company decided not to progress with the planned
launch of Qtrilmet
(fixed-dose combination of metformin, Forxiga and Onglyza) in the EU, reflecting adverse
changes in the competitive landscape. This followed the recent
decision not to launch Qternmet in the US for the same
reason.
AstraZeneca made a regulatory submission during the period
for Brilinta in stroke in China, based on results from the
THALES Phase III trial.
Table 31: Key large CVRM outcomes trials
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
Farxiga
|
|
Phase
III
DAPA-HF
|
c.4,500
patients with HF with reduced ejection fraction, with and without
T2D
|
Arm 1:
Farxiga 10mg or 5mg
QD48 + SoC
Arm 2:
placebo + SoC
|
Time to
first occurrence of CV death or hospitalisation due to HF or an
urgent HF visit
|
FPCD
Q1
2017
LPCD
Q4
2018
|
Primary
endpoint met
|
Phase
III
DELIVER
|
c.4,700
patients with HF (HFpEF) with and without T2D
|
Arm 1:
Farxiga 10mg
QD
Arm 2:
placebo
|
Time to
first occurrence of CV death or worsening HF
|
FPCD
Q4
2018
First
data anticipatedH2 2021
|
Recruitment
ongoing
Fast
Track designation (US)
|
Phase
III
DAPA-CKD
|
c.4,000
patients with CKD, with and without T2D
|
Arm 1:
Farxiga 10mg or 5mg
QD
Arm 2:
placebo
|
Time to
first occurrence of ≥ 50% sustained decline in eGFR or
reaching ESRD or CV death or renal death
|
FPCD
Q1
2017
LPCD
Q1
2020
|
Trial
stopped early based on recommendation from an IDMC49
Primary
endpoint and secondary endpoints met
Fast
Track designation (US)
|
Brilinta
|
|
Phase
III THEMIS
|
c.19,000
patients with T2D and CAD without a history of MI or
stroke
|
Arm 1:
Brilinta 60mg
BID50
Arm 2:
placebo BID on a background of aspirin if not
contra-indicated51 or not tolerated
|
Composite
of CV death, non-fatal MI and non-fatal stroke
|
FPCD
Q1
2014
LPCD
Q2
2016
|
Primary
endpoint met
|
Phase
III
THALES
|
c.11,000
patients with acute ischaemic stroke52 or transient ischaemic
attack
|
Arm 1:
Brilinta 90mg
BID
Arm 2:
placebo BID on a background of aspirin if not contra-indicated or
not tolerated
|
Prevention
of the composite of subsequent stroke and death at 30
days
|
FPCD
Q1
2018
LPCD
Q4
2019
|
Primary
endpoint met
Fast
Track
designation
(US)
|
a)
Lokelma
(hyperkalaemia)
In
August 2020, Premier Inc. (Premier), a leading healthcare
improvement company, announced a collaboration with AstraZeneca to help reduce
hospitalisations among patients with hyperkalaemia, which is
characterised by higher-than-normal potassium levels. Premier has
implemented evidence-based care practices with nearly 370 hospitals
across the US, designed to prevent patients with hyperkalaemia from
requiring treatment in the acute-care setting. The companies have
developed a protocol for monitoring and treating patients,
including the potential use of Lokelma, for the treatment of
hyperkalaemia in adults. These evidence-based care practices allow
hospitals to improve care delivery to potentially reduce the risk
for admissions and re-admissions for patients with
hyperkalaemia.
During
the period, AstraZeneca presented more than 40 roxadustat abstracts
at the ASN Kidney Week 2020 Reimagined providing new insights on
the potential of the medicine to transform the standard of care in
anaemia of CKD across key patient sub-populations. Notable
abstracts included:
-
Two late-breaking
presentations of pooled analyses of Phase III trials investigating
the association between haemoglobin (Hb) levels and CV outcomes in
NDD and DD CKD patients. In both analyses, incidence rates of
adjudicated major adverse cardiac events (MACE53) and MACE+54 were evaluated based on Hb level
immediately before the event. In the both the NDD and DD CKD
population, MACE and MACE+ rates were highest when Hb was less than
8g/dL, and the rates declined as Hb increased and were lowest when
achieved Hb levels were greater than or equal to
10g/dL.
-
An oral
presentation exploring whether roxadustat can reduce the risk of
hospitalisation for HF, a common comorbidity in patients with
CKD
-
Analyses of whether
roxadustat has the potential to reduce the risk of red blood cell
transfusions, a treatment for anaemia associated with additional
complications, in both NDD CKD and DD CKD patients
-
An analysis
exploring the effect of roxadustat on achieving Hb ≥10 g/dL
in patients with NDD CKD
-
New data from
pooled analyses of Phase III trials on DD CKD patient subgroups,
including those who are receiving peritoneal dialysis and are new
to dialysis
-
An oral
presentation highlighting that roxadustat is not associated with an
increased risk of neoplasm in patients with CKD
anaemia
Roxadustat
is currently undergoing US FDA regulatory review, with a decision
expected before the end of this year. In the year to date, FibroGen
and AstraZeneca made several regulatory submissions in RoW
countries, including Australia, Brazil, Canada, Chile, India,
Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and
Columbia.
FibroGen
and Astellas have received regulatory approval in DD, and
regulatory submission acceptance for NDD in Japan. In the EU, the
companies received submission acceptance from the EMA in May
2020.
Respiratory & Immunology
At the
2020 European Respiratory Society International Virtual Congress
(ERS 2020), the Company presented 60 abstracts, including 10 oral
presentations and three ‘late-breakers’ from across the
inhaled and biologics portfolio and pipeline. Highlights included a
post-hoc analysis of the ETHOS Phase III trial, showing a
consistent benefit of Breztri in reducing the rate of
moderate or severe COPD exacerbations across all seasons, compared
with dual therapy.
a)
Symbicort
(mild
asthma)
During
the period, the Company received submission acceptance in the EU
for Symbicort Turbuhaler as
an anti-inflammatory reliever for patients with mild
asthma.
During
the period, Breztri, under
the name Trixeo, received a
positive opinion from the CHMP, recommending the medicine for
marketing authorisation in the EU for maintenance treatment in
adult patients with moderate to severe chronic COPD who are not
adequately treated by a combination of an ICS and a LABA, or a
combination of a LABA and a long-acting muscarinic
antagonist.
c)
Fasenra
(eosinophil-driven
diseases)
In
September 2020, AstraZeneca announced positive results from the
OSTRO Phase III trial for Fasenra, in patients with chronic
rhinosinusitis with nasal polyps55. The trial evaluated the effect of
Fasenra on nasal-polyp
burden, assessed by change from baseline in endoscopic total
nasal-polyp score (NPS), at week 40 compared to placebo. In
addition, the trial evaluated the effect of Fasenra on patient-reported nasal
blockage, assessed by change from baseline in mean nasal-blockage
score (NBS), at week 40, compared to placebo. OSTRO recruited 413
patients in Europe and North America. The trial met its co-primary
endpoints, demonstrating a statistically significant improvement in
the endoscopic total NPS and NBS, compared to placebo, in patients
with severe bilateral nasal polyps56 who were still symptomatic, despite
continued treatment with SoC. The following interventions are
considered SoC for nasal polyps: intranasal corticosteroids, prior
surgery and/or use of systemic corticosteroids.
In
October 2020, AstraZeneca announced high-level results from the
PONENTE Phase IIIb open-label trial, which showed OCS-dependent
asthma patients across baseline blood eosinophil counts receiving
Fasenra were able to
eliminate the use of maintenance OCS.
On the
first primary endpoint, 62% (95% CI: 58.2-66.1) of patients
achieved complete elimination of daily OCS use. On the second
primary endpoint, 81% (95% CI 77.2-83.7) of patients achieved
complete elimination or were able to reduce their daily OCS dose to
5mg or less when further reduction was not possible due to adrenal
insufficiency. Both primary endpoints were sustained for at least
four weeks while maintaining asthma control.
Table 32: Key Fasenra
lifecycle management trials
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
Phase
III OSTRO
|
Patients
aged 18-75 years with severe bilateral nasal polyps; symptomatic,
despite SoC
|
Placebo
or Fasenra 30mg
Q8W57 SC58
|
Nasal-polyps
burden and reported nasal blockage
|
FPCD
Q1
2018
LPCD
Q2
2019
|
Co-primary
endpoints met
|
Phase
III RESOLUTE
|
Patients
with moderate to very severe COPD with a history of frequent COPD
exacerbations and elevated peripheral blood
eosinophils
|
Placebo
or Fasenra 100mg Q8W
SC
|
Annualised
rate of moderate or severe COPD exacerbations
|
FPCD
Q4
2019
Data
anticipated 2021+
|
Recruitment
ongoing
|
Phase
III
MANDARA
|
Eosinophilic
granulomatosis with polyangiitis59
|
Fasenra 30mg or
mepolizumab
3x100mg Q4W
|
Proportion
of patients who achieve remission, defined as a score60 =0 and an OCS dose ≤4 mg/day at
weeks 36 and 48
|
FPCD
Q4
2019
Data
anticipated
2021+
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
Phase
III
NATRON
|
|
Placebo
or Fasenra 30mg Q4W
SC
|
Time to
HES worsening flare or any cytotoxic and/or immuno-suppressive
therapy increase or hospitalisation
|
FPCD
Q3
2020
Data
anticipated 2021+
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
Phase
III
MESSINA
|
Eosinophilic
oesophagitis62
|
Placebo
or Fasenra 30mg Q4W
SC
|
Proportion
of patients with a histologic response63
Changes
from baseline in dysphagia64 PRO65
|
FPCD
Q4
2020
Data
anticipated 2021+
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
Phase
III
FJORD
|
|
Placebo
or Fasenra 30mg Q4W
SC
|
Proportion
of patients with partial or
complete
remission of BP whilst off OCS for ≥2 months
at Week
36
|
Data
anticipated 2021+
|
Initiating
|
d)
Anifrolumab (lupus: SLE)
During
the period, the Company received regulatory submission acceptances
for anifrolumab from the US FDA and the EMA for the treatment of
adult patients with moderate to severe SLE. AstraZeneca’s
submissions were based on results from the two TULIP Phase III
trials and the MUSE Phase II trial, in which a reduction in disease
activity and OCS use, and improvement in lupus skin activity were
observed with anifrolumab added to SoC compared to placebo and
SoC.
Anifrolumab
has a well-characterised safety profile, based on the safety and
tolerability findings across all three trials. The Prescription
Drug User Fee Act date, the US FDA action date to provide a
regulatory decision, is anticipated to be in the third quarter of
2021. The EMA regulatory decision is expected in the second half of
2021.
COVID-19
a)
AZD1222 (SARS-CoV-2 vaccine)
During
the period, the University of Oxford and AstraZeneca continued the
recruitment of participants into the global clinical trials of the
recombinant adenovirus vaccine, AZD1222, reaching c.23,000
participants across trials in the UK, Brazil, South Africa and the
US.
In
October 2020, the EMA announced that the CHMP had started a rolling
review of data for AZD1222. A rolling review is one of the
regulatory tools that the EMA uses to flexibly progress the
assessment of a promising medicine or vaccine during a
public-health emergency. AZD1222 was the first potential COVID-19
vaccine to be evaluated in the EU under these
arrangements.
In
September 2020, a voluntary pause to vaccination in the global
trials was triggered following an unexplained illness in one of the
participants receiving the vaccine in the UK Phase II/III trial.
The standard review process for trial-safety events involves the
examination of safety data by independent monitoring committees.
The recommendations from the committees were shared with
international regulators. The US FDA asked for additional
information, issuing a ‘clinical hold’ to the US Phase
III trial during its review. All regulatory authorities
subsequently confirmed that the trials were safe to resume, and
enrolment has recommenced. It is commonplace that, in large-scale
trials, some participants will become unwell, and every unexplained
case has to be independently evaluated to ensure careful assessment
of safety.
Data on
immunogenicity and safety of in older adults was presented at
IDWeek showing AZD1222 has an acceptable tolerability
profile and is immunogenic in adults above 18 years of age,
including older adults. Stronger immune responses were shown after
a second dose given one month apart, across all adult age ranges.
Local and systemic reactions were lower in older adults than
younger adults (<55 years) and reactions were lessened after the
second dose.
Results
from late-stage trials are anticipated later this year, depending
on the rate of infection within the communities where the clinical
trials are being conducted. Data readouts will be submitted to
regulators and published in peer-reviewed scientific
journals.
b)
AZD7442 (long-acting antibody combination for the prevention and
treatment of COVID-19
During
the period, AstraZeneca announced the initiation of a Phase I trial
for AZD7442, a potential LAAB combination therapy for the
prevention and treatment of COVID-19 and in October 2020 announced
plans to advance AZD7442 into two Phase III clinical trials in more
than 6,000 participants at sites in and outside the US to evaluate
safety and efficacy of a 300mg intramuscular (IM) dose in
preventing infection and further trials in approximately 4,000
patients for the treatment of COVID-19 with IM or intravenous doses
ranging from 300-900mg. The LAAB combination has been engineered
with AstraZeneca's proprietary half-life extension technology to
increase the durability of the therapy for six to 12 months
following a single administration.
The US
Government has committed support of around $486m for the
development and supply of AZD7442 under an agreement with the
Biomedical Advanced Research and Development Authority and the
Department of Defense Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense. AstraZeneca plans to
supply up to 100,000 doses starting towards the end of 2020 and the
US Government can acquire up to an additional one million doses in
2021 under a separate agreement.
c)
Other new and existing medicines in the treatment of
COVID-19
In the
year to date, as well as developing preventative approaches against
the SARS-CoV-2 virus, the Company also initiated clinical trials,
detailed in the table below, to investigate AstraZeneca’s new
and existing medicines to treat the infection by suppressing the
body’s overactive immune response or protecting from serious
complications, such as organ failure.
AstraZeneca
is continuing to evaluate the use of Calquence (acalabrutinib), approved in
a number of countries for the treatment of CLL, in the CALAVI Phase
II trial, which is assessing the suppression of the cytokine storm
that inflames the lungs and other organs of some COVID-19 patients.
The Company is also looking at the prospect of protecting organs in
the DARE-19 Phase III trial67, assessing whether Farxiga can potentially reduce organ
failure. Farxiga is being
evaluated in combination with ambrisentan in the Cambridge
University Hospitals NHS Trust’s TACTIC-E Phase II trial.
Farxiga is an oral SGLT2
inhibitor, principally used as a treatment for T2D, that has
demonstrated benefits in HF and CKD.
The
Company has joined the UK Government’s ACCORD
proof-of-concept clinical-trial platform, to speed the development
of medicines for patients with COVID-19 and is supplying
Pulmicort and Symbicort to externally sponsored
research programmes, including the trials detailed
below.
Table 33: Key trials in COVID-1968
Trial
|
Population
|
Design
|
Timeline
|
Status
|
AZD1222
|
Phase
I/II
(UK)
|
Protection
against COVID-19 in participants aged 18-55
|
MenACWY
or
AZD1222
n=1,077
|
FPCD
Q2
2020
LPCD
Q2
2020
|
Initial
data readout
|
Phase
II/III
(UK)
|
Protection
against COVID-19 in participants aged 18-55, 55+ and
paediatric
|
MenACWY
or
AZD1222
n=12,390
|
FPCD
Q2
2020
First
data anticipated
Q4
2020
|
Recruitment
ongoing
|
Phase
III
D8110C00001
(US,
global)
|
Protection
against COVID-19 in participants aged 18+
|
Placebo
or AZD1222
n=40,000
|
FPCD
Q3
2020
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
Phase
I/II
COV005ChAdOx1
nCoV-19 ZA70
(South
Africa)
|
Protection
against COVID-19 in participants aged 18-65
|
Placebo
or AZD1222
n=2,020
|
FPCD
Q2
2020
First
data anticipated
Q4
2020
|
Recruitment
ongoing
|
Phase
II/III
(Brazil)
|
Protection
against COVID-19 in participants aged 18-55
|
MenACWY
or
AZD1222
n=10,000
|
FPCD
Q2
2020
First
data anticipated
Q4
2020
|
Recruitment
ongoing
|
AZD7442
|
Phase
I
|
COVID-19
|
Placebo
or AZD7442
|
-
|
Recruitment
completed
|
Phase
III
PROVENT
|
Protection
against COVID-19
(prophylaxis)
|
Placebo
or AZD7442
n=5,000
|
First
data anticipated
H1
2021
|
Initiating
|
Phase
III
STORMCHASER
|
Protection
against COVID-19
(post-exposure
prophylaxis)
|
Placebo
or AZD7442
n=1,125
|
First
data anticipated
H1
2021
|
Initiating
|
Phase
III
|
COVID-19
(treatment)
|
Current
SoC or AZD7442
n=c.4,000
|
First
data anticipated
H1
2021
|
Initiating
|
Acalabrutinib
|
Phase
II
CALAVI
(US and
ex-US)
|
COVID-19
|
Current
SoC or SoC+ acalabrutinib
|
First
data anticipated
Q4
2020
|
Recruitment
completed
|
Farxiga
|
Phase
III
DARE-19
|
COVID-19
|
Current
SoC or current SoC +
Farxiga
|
First
data anticipated
Q4
2020
|
Recruitment
ongoing
|
Phase
II
|
COVID-19
|
Current
SoC or current SoC + Farxiga + ambrisentan
|
First
data anticipated
Q4
2020
|
Recruitment
ongoing
|
Symbicort
|
Phase
IIIa
|
COVID-19
|
Current
SoC or SoC + Symbicort
|
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
Pulmicort
|
Phase
IIIa
|
COVID-19
|
Current
SoC or SoC + Pulmicort
|
First
data anticipated
Q4
2020
|
Recruitment
ongoing
|
Phase
IIIa
|
COVID-19
|
Current
SoC or SoC + Pulmicort
|
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
MEDI3506
|
Phase
II
|
COVID-19
|
Current
SoC or current SoC + MEDI3506
|
First
data anticipated
H1
2021
|
Recruitment
ongoing
|
Other developments
During
the period, AstraZeneca and Samsung Biologics announced the signing
of a long-term supply agreement, under which Samsung Biologics will
provide large-scale commercial manufacturing capacity for substance
and product for AstraZeneca’s biologics
medicines.
In
October 2020, Lonza Group AG announced an agreement to provide
capacity for the manufacturing of AZD7442 at their new facility in
Portsmouth, NH, US, with operations expected to start in H1
2021.
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.
Interim Financial Statements
Table 34: Condensed consolidated statement of comprehensive income
- YTD 2020
For the nine
months ended 30
September
|
2020
|
2019
|
$m
|
$m
|
Total Revenue
|
19,207
|
17,720
|
Product Sales
|
18,879
|
17,315
|
Collaboration Revenue
|
328
|
405
|
|
|
|
Cost of Sales
|
(3,774)
|
(3,543)
|
|
|
|
Gross Profit
|
15,433
|
14,177
|
|
|
|
Distribution costs
|
(290)
|
(247)
|
Research and development expense
|
(4,272)
|
(3,968)
|
Selling, general and administrative costs
|
(8,084)
|
(8,656)
|
Other operating income and expense
|
888
|
1,041
|
|
|
|
Operating Profit
|
3,675
|
2,347
|
Finance income
|
80
|
133
|
Finance expense
|
(985)
|
(1,081)
|
Share of after-tax losses in associates and joint
ventures
|
(21)
|
(91)
|
|
|
|
Profit Before Tax
|
2,749
|
1,308
|
Taxation
|
(610)
|
(358)
|
Profit for the period
|
2,139
|
950
|
|
|
|
Other comprehensive income
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
Remeasurement of the defined benefit pension liability
|
(191)
|
(151)
|
Net gains/(losses) on equity investments measured at fair value
through other comprehensive income
|
974
|
(136)
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
(1)
|
(1)
|
Tax on items that will not be reclassified to profit or
loss
|
(70)
|
21
|
|
712
|
(267)
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
Foreign exchange arising on consolidation
|
(121)
|
(385)
|
Foreign exchange arising on designating borrowings in net
investment hedges
|
145
|
(491)
|
Fair value movements on cash flow hedges
|
2
|
(156)
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
(115)
|
109
|
Fair value movements on derivatives designated in net investment
hedges
|
39
|
35
|
Costs of hedging
|
10
|
(35)
|
Tax on items that may be reclassified subsequently to profit or
loss
|
7
|
62
|
|
(33)
|
(861)
|
Other comprehensive income/(loss) for the period, net of
tax
|
679
|
(1,128)
|
Total comprehensive income/(loss) for the period
|
2,818
|
(178)
|
|
|
|
Profit attributable to:
|
|
|
Owners of the Parent
|
2,184
|
1,022
|
Non-controlling interests
|
(45)
|
(72)
|
|
2,139
|
950
|
Total comprehensive income attributable to:
|
|
|
Owners of the Parent
|
2,864
|
(107)
|
Non-controlling interests
|
(46)
|
(71)
|
|
2,818
|
(178)
|
Basic earnings per $0.25 Ordinary Share
|
$1.66
|
$0.79
|
Diluted earnings per $0.25 Ordinary Share
|
$1.66
|
$0.79
|
|
|
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,312
|
1,297
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,313
|
1,297
|
Table 35: Condensed consolidated statement of comprehensive income
- Q3 2020
For the quarter ended 30 September
|
2020
|
2019
|
$m
|
$m
|
Total Revenue
|
6,578
|
6,406
|
Product Sales
|
6,520
|
6,132
|
Collaboration Revenue
|
58
|
274
|
Cost of Sales
|
(1,370)
|
(1,351)
|
Gross Profit
|
5,208
|
5,055
|
|
|
|
Distribution costs
|
(99)
|
(88)
|
Research and development expense
|
(1,495)
|
(1,346)
|
Selling, general and administrative costs
|
(2,730)
|
(3,199)
|
Other operating income and expense
|
287
|
335
|
|
|
|
Operating Profit
|
1,171
|
757
|
Finance income
|
7
|
37
|
Finance expense
|
(324)
|
(353)
|
Share of after-tax losses in associates and joint
ventures
|
(1)
|
(32)
|
|
|
|
Profit Before Tax
|
853
|
409
|
Taxation
|
(202)
|
(129)
|
Profit for the period
|
651
|
280
|
|
|
|
Other comprehensive income
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
Remeasurement of the defined benefit pension liability
|
14
|
96
|
Net losses on equity investments measured at fair value through
other comprehensive income
|
(95)
|
(82)
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
(7)
|
1
|
Tax on items that will not be reclassified to profit or
loss
|
9
|
4
|
|
(79)
|
19
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
Foreign exchange arising on consolidation
|
373
|
(299)
|
Foreign exchange arising on designating borrowings in net
investment hedges
|
162
|
(305)
|
Fair value movements on cash flow hedges
|
133
|
(113)
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
(114)
|
95
|
Fair value movements on derivatives designated in net investment
hedges
|
(21)
|
44
|
Costs of hedging
|
6
|
(38)
|
Tax on items that may be reclassified subsequently to profit or
loss
|
(22)
|
42
|
|
517
|
(574)
|
Other comprehensive income/(loss) for the period, net of
tax
|
438
|
(555)
|
Total comprehensive income/(loss) for the period
|
1,089
|
(275)
|
|
|
|
Profit attributable to:
|
|
|
Owners of the Parent
|
648
|
299
|
Non-controlling interests
|
3
|
(19)
|
|
651
|
280
|
Total comprehensive income attributable to:
|
|
|
Owners of the Parent
|
1,087
|
(257)
|
Non-controlling interests
|
2
|
(18)
|
|
1,089
|
(275)
|
Basic earnings per $0.25 Ordinary Share
|
$0.49
|
$0.23
|
Diluted earnings per $0.25 Ordinary Share
|
$0.49
|
$0.23
|
|
|
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,312
|
1,312
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,313
|
1,312
|
Table 36: Condensed consolidated statement of financial
position
|
At 30 Sep 2020
|
At 31 Dec 2019
|
At 30 Sep 2019
|
$m
|
$m
|
$m
|
Assets
|
|
|
|
Non-current assets
|
|
|
|
Property, plant and equipment
|
7,707
|
7,688
|
7,317
|
Right-of-use assets
|
653
|
647
|
690
|
Goodwill
|
11,711
|
11,668
|
11,595
|
Intangible assets
|
20,613
|
20,833
|
21,454
|
Investments in associates and joint ventures
|
42
|
58
|
43
|
Other investments
|
1,173
|
1,401
|
1,293
|
Derivative financial instruments
|
119
|
61
|
56
|
Other receivables
|
685
|
740
|
384
|
Deferred tax assets
|
3,243
|
2,718
|
2,554
|
|
45,946
|
45,814
|
45,386
|
Current assets
|
|
|
|
Inventories
|
3,683
|
3,193
|
3,129
|
Trade and other receivables
|
5,668
|
5,761
|
5,279
|
Other investments
|
374
|
849
|
813
|
Derivative financial instruments
|
37
|
36
|
9
|
Intangible assets
|
-
|
-
|
95
|
Income tax receivable
|
332
|
285
|
228
|
Cash and cash equivalents
|
8,072
|
5,369
|
3,967
|
Assets held for sale
|
-
|
70
|
-
|
|
18,166
|
15,563
|
13,520
|
Total assets
|
64,112
|
61,377
|
58,906
|
Liabilities
|
|
|
|
Current liabilities
|
|
|
|
Interest-bearing loans and borrowings
|
(3,402)
|
(1,822)
|
(228)
|
Lease liabilities
|
(183)
|
(188)
|
(349)
|
Trade and other payables
|
(13,406)
|
(13,987)
|
(12,538)
|
Derivative financial instruments
|
(9)
|
(36)
|
(26)
|
Provisions
|
(621)
|
(723)
|
(401)
|
Income tax payable
|
(1,321)
|
(1,361)
|
(1,234)
|
|
(18,942)
|
(18,117)
|
(14,776)
|
Non-current liabilities
|
|
|
|
Interest-bearing loans and borrowings
|
(18,271)
|
(15,730)
|
(17,218)
|
Lease liabilities
|
(483)
|
(487)
|
(363)
|
Derivative financial instruments
|
(16)
|
(18)
|
(55)
|
Deferred tax liabilities
|
(2,576)
|
(2,490)
|
(2,595)
|
Retirement benefit obligations
|
(2,895)
|
(2,807)
|
(2,392)
|
Provisions
|
(854)
|
(841)
|
(990)
|
Other payables
|
(6,457)
|
(6,291)
|
(6,848)
|
|
(31,552)
|
(28,664)
|
(30,461)
|
Total liabilities
|
(50,494)
|
(46,781)
|
(45,237)
|
Net assets
|
13,618
|
14,596
|
13,669
|
Equity
|
|
|
|
Capital and reserves attributable to equity holders of the
Parent
|
|
|
|
Share capital
|
328
|
328
|
328
|
Share premium account
|
7,952
|
7,941
|
7,919
|
Other reserves
|
2,039
|
2,046
|
2,052
|
Retained earnings
|
1,876
|
2,812
|
1,865
|
|
12,195
|
13,127
|
12,164
|
Non-controlling interests
|
1,423
|
1,469
|
1,505
|
Total equity
|
13,618
|
14,596
|
13,669
|
Table 37: Condensed consolidated statement of changes in
equity
|
Share capital
|
Share premium account
|
Other reserves
|
Retained earnings
|
Total attributable to owners of the parent
|
Non-controlling interests
|
Total equity
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
At 1 Jan 2019
|
317
|
4,427
|
2,041
|
5,683
|
12,468
|
1,576
|
14,044
|
|
|
|
|
|
|
|
|
Adoption of new accounting standards
|
-
|
-
|
-
|
54
|
54
|
-
|
54
|
Profit for the period
|
-
|
-
|
-
|
1,022
|
1,022
|
(72)
|
950
|
Other comprehensive loss
|
-
|
-
|
-
|
(1,129)
|
(1,129)
|
1
|
(1,128)
|
Transfer to other reserves
|
-
|
-
|
11
|
(11)
|
-
|
-
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(3,583)
|
(3,583)
|
-
|
(3,583)
|
Issue of Ordinary Shares
|
11
|
3,492
|
-
|
-
|
3,503
|
-
|
3,503
|
Share-based payments charge for the period
|
-
|
-
|
-
|
154
|
154
|
-
|
154
|
Settlement of share plan awards
|
-
|
-
|
-
|
(325)
|
(325)
|
-
|
(325)
|
|
|
|
|
|
|
|
|
Net movement
|
11
|
3,492
|
11
|
(3,818)
|
(304)
|
(71)
|
(375)
|
|
|
|
|
|
|
|
|
At 30 Sep 2019
|
328
|
7,919
|
2,052
|
1,865
|
12,164
|
1,505
|
13,669
|
|
|
|
|
|
|
|
|
At 1 Jan 2020
|
328
|
7,941
|
2,046
|
2,812
|
13,127
|
1,469
|
14,596
|
|
|
|
|
|
|
|
|
Profit for the period
|
-
|
-
|
-
|
2,184
|
2,184
|
(45)
|
2,139
|
Other comprehensive income
|
-
|
-
|
-
|
680
|
680
|
(1)
|
679
|
Transfer to other reserves
|
-
|
-
|
(7)
|
7
|
-
|
-
|
-
|
Transactions with owners:
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(3,669)
|
(3,669)
|
-
|
(3,669)
|
Issue of Ordinary Shares
|
-
|
11
|
-
|
-
|
11
|
-
|
11
|
Share-based payments charge for the period
|
-
|
-
|
-
|
187
|
187
|
-
|
187
|
Settlement of share plan awards
|
-
|
-
|
-
|
(325)
|
(325)
|
-
|
(325)
|
|
|
|
|
|
|
|
|
Net movement
|
-
|
11
|
(7)
|
(936)
|
(932)
|
(46)
|
(978)
|
|
|
|
|
|
|
|
|
At 30 Sep 2020
|
328
|
7,952
|
2,039
|
1,876
|
12,195
|
1,423
|
13,618
|
Table 38: Condensed consolidated statement of cash
flows
For the nine
months ended 30
September
|
2020
|
2019
|
$m
|
$m
|
Cash flows from operating activities
|
|
|
Profit Before Tax
|
2,749
|
1,308
|
Finance income and expense
|
905
|
948
|
Share of after-tax losses of associates and joint
ventures
|
21
|
91
|
Depreciation, amortisation and impairment
|
2,352
|
2,119
|
Increase in working capital and short-term provisions
|
(255)
|
(812)
|
Gains on disposal of intangible assets
|
(535)
|
(833)
|
Fair value movements on contingent consideration arising from
business combinations
|
(14)
|
(13)
|
Non-cash and other movements
|
(484)
|
326
|
|
|
|
Cash generated from operations
|
4,739
|
3,134
|
Interest paid
|
(517)
|
(575)
|
Tax paid
|
(1,221)
|
(965)
|
|
|
|
Net cash inflow from operating activities
|
3,001
|
1,594
|
|
|
|
Cash flows from investing activities
|
|
|
Payment of contingent consideration from business
combinations
|
(663)
|
(487)
|
Purchase of property, plant and equipment
|
(598)
|
(659)
|
Disposal of property, plant and equipment
|
67
|
31
|
Purchase of intangible assets
|
(1,460)
|
(1,416)
|
Disposal of intangible assets
|
664
|
1,400
|
Movement
in profit-participation liability
|
-
|
150
|
Purchase of non-current asset investments
|
(119)
|
(6)
|
Disposal of non-current asset investments
|
1,121
|
18
|
Movement in short-term investments, fixed deposits and other
investing instruments
|
530
|
196
|
Payments to associates and joint ventures
|
(8)
|
(49)
|
Interest received
|
43
|
107
|
|
|
|
Net cash outflow from investing activities
|
(423)
|
(715)
|
|
|
|
Net cash inflow before financing activities
|
2,578
|
879
|
|
|
|
Cash flows from financing activities
|
|
|
Proceeds from issue of share capital
|
11
|
3,503
|
Issue of loans
|
2,968
|
500
|
Repayment of loans
|
-
|
(1,500)
|
Dividends paid
|
(3,572)
|
(3,592)
|
Hedge contracts relating to dividend payments
|
(101)
|
4
|
Repayment of obligations under leases
|
(157)
|
(131)
|
Movement in short-term borrowings
|
858
|
(555)
|
|
|
|
Net cash inflow/(outflow) from financing activities
|
7
|
(1,771)
|
|
|
|
Net increase/(decrease) in cash and cash equivalents in the
period
|
2,585
|
(892)
|
Cash and cash equivalents at the beginning of the
period
|
5,223
|
4,671
|
Exchange rate effects
|
(14)
|
-
|
|
|
|
Cash and cash equivalents at the end of the period
|
7,794
|
3,779
|
|
|
|
Cash and cash equivalents consist of:
|
|
|
Cash and cash equivalents
|
8,072
|
3,967
|
Overdrafts
|
(278)
|
(188)
|
|
|
|
|
7,794
|
3,779
|
Notes to the Interim Financial Statements
1)
Basis of preparation and accounting policies
These
unaudited Interim Financial Statements for the nine months ended 30
September 2020 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 EU. The UK is in the process of establishing its post-Brexit
IFRS-adoption authority, which is expected to be operational later
in 2020, but for the current time, will follow the EU approval
process.
The
unaudited Interim Financial Statements for the nine months ended 30
September 2020 were approved by the Board of Directors for
publication on 5 November 2020.
The
annual financial statements of the Group are prepared in accordance
with IFRSs as issued by the IASB and adopted by 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 2019.
IFRS 3
An
amendment to IFRS 3 ‘Business Combinations’ relating to
the definition of a business was endorsed by the EU in April 2020,
with an effective date of 1 January 2020. The change in definition
of a business within IFRS 3 introduces an optional concentration
test to perform a simplified assessment of whether an acquired set
of activities and assets is or is not a business on a transaction
by transaction basis. This change is expected to provide more
reliable and comparable information about certain transactions as
it provides more consistency in accounting in the pharmaceutical
industry for substantially similar transactions for which, under
the previous definition, may have been accounted in different ways,
despite limited differences in substance. The Group has adopted
this amendment from the effective date.
IFRS 9, IAS 39 and IFRS 7
Amendments
to IFRS 9 ‘Financial Instruments’, IAS 39
‘Financial Instruments: Recognition and Measurement’
and IFRS 7 ‘Financial Instruments: Disclosures’
relating to interbank offered rate (IBOR) reform were endorsed by
the EU in January 2020; the Group adopted the amendments in the
year ended 31 December 2019. The replacement of benchmark interest
rates, such as the London Inter-bank Offered Rate (LIBOR) and other
IBORs is a priority for global regulators. The amendments provide
relief from applying specific hedge-accounting requirements to
hedge relationships directly affected by IBOR reform and have the
effect that IBOR reform should generally not cause hedge accounting
to terminate. There is no financial impact from the early adoption
of these amendments.
The
Group has one IFRS 9 designated hedge relationship that is
potentially 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 are currently being
assessed.
Government grants
Government
grants are recognised in the Consolidated statement of
comprehensive income so as to match with the related expenses that
they are intended to compensate. Where grants are received in
advance of the related expenses, they are initially recognised in
the Consolidated statement of financial position and released to
match the related expenditure.
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 30 September 2020 and the financial
position as at 30 September 2020, specifically considering the
impact on key judgements and significant estimates as detailed on
page 173 of the Annual Report and 20-F
Information 2019 along with a several other areas of
increased risk.
A
detailed assessment has been performed, focussing on the following
areas:
-
recoverable value
of goodwill, intangible assets and property, plant and
equipment
-
impact on key
assumptions used to estimate contingent-consideration
liabilities
-
key assumptions
used in estimating the Group’s defined-benefit pension
obligations
-
basis for
estimating clinical-trial accruals
-
key assumptions
used in estimating rebates, chargebacks and returns for US Product
Sales
-
valuations of
unlisted equity investments
-
expected credit
losses associated with changes in credit risk relating to trade and
other receivables
-
net realisable
value of inventories
-
fair value of
certain financial instruments
-
recoverability of
deferred-tax assets
-
effectiveness of
hedge relationships
There
were no material accounting impacts identified relating to the
above areas during the nine-month period ended 30 September
2020.
The
Group will continue to monitor these areas of increased judgement,
estimation and risk for material changes.
Going concern
The
Group has considerable financial resources available. As at 30
September 2020, the Group had $12.6bn in financial resources (cash
and cash-equivalent balances of $8.1bn, $0.4bn of liquid fixed
income securities and undrawn committed bank facilities of $4.1bn,
of which $3.4bn is available until April 2022, $0.5bn is available
until November 2021 and $0.2bn is available until December 2020),
with only $3.6bn of borrowings due within one year). Subsequent to
30 September 2020, the $3.4bn committed facilities were extended to
April 2024, and the $0.7bn facilities amended and made available
until November 2022. 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. In the
current environment, the Directors have also considered the impact
of possible future COVID-19 related scenarios and believe the Group
retains sufficient liquidity to continue to operate.
Based
on the above paragraph, 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 2019.
Financial information
The
comparative figures for the financial year ended 31 December 2019
are not the Group’s statutory accounts for that financial
year. Those accounts have been reported on by the Group’s
auditors and have been delivered to the registrar of companies;
their report was (i) unqualified, (ii) did not include a reference
to any matters to which the auditors drew attention by way of
emphasis without qualifying their report, and (iii) did not contain
a statement under section 498(2) or (3) of the Companies Act
2006.
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 impairment charge of $188m
being recorded against intangible assets during the nine months
ended 30 September 2020.
During
the first quarter of 2020, a charge of $102m was recorded in
relation to Bydureon
(revised carrying amount of $596m). The impairment was driven by an
overall reduction in forecast Total Revenue over the remaining
asset life, reflecting expectations of returns from promotional
activities, including a level of anticipated impact resulting from
the restrictions in place due to the COVID-19 pandemic. If Total
Revenue projections for Bydureon were to decline by a further
10% over the forecast period, it would result in a reduction in the
recoverable amount of c.$100m.
During
the second quarter of 2020, charges recorded included $65m and $31m
in relation to Duaklir and
Eklira/Tudorza, respectively. The revised
carrying amounts are $281m and $127m, respectively. In addition,
there was also a $95m impairment reversal in relation to
FluMist with revised
carrying amount of $253m.
The
$95m impairment reversal in relation to FluMist reflected a change in expected
sales volumes, following pre-orders received during the
period.
The
impairment charges for Duaklir and Eklira/Tudorza were a consequence of revised
market-volume and share assumptions, following adverse performances
during H1 2020, compared to previous forecasts during the H1 2020.
If Total Revenue projections for these medicines were to decline by
a further 20% over the forecast period, it would result in
additional reductions to the recoverable amounts of c.$60m for
Duaklir and c.$30m for
Eklira/Tudorza. During the third quarter,
additional impairment charges were recorded of $34m and $14m in
relation to the US rights for Duaklir and Eklira/Tudorza, respectively, (revised
carrying amount of $17m and $53m, respectively).
During
the third quarter, an additional impairment for a development asset
of $21m was taken, due to the cessation of the development
programme.
The
table below provides an analysis of Net Debt and a reconciliation
of Net Cash Flow to the movement in Net Debt. The Group monitors
Net Debt as part of its capital-management policy as described in
Note 27 of the Annual Report and Form
20-F Information 2019. Net Debt is a non-GAAP financial
measure.
Table 39: Net Debt
|
At
1 Jan 2020
|
Cash flow
|
Non-cash & other
|
Exchange movements
|
At
30 Sep 2020
|
$m
|
$m
|
$m
|
$m
|
$m
|
Non-current instalments of loans
|
(15,730)
|
(2,968)
|
545
|
(118)
|
(18,271)
|
Non-current instalments of leases
|
(487)
|
-
|
2
|
2
|
(483)
|
|
|
|
|
|
|
Total long-term debt
|
(16,217)
|
(2,968)
|
547
|
(116)
|
(18,754)
|
|
|
|
|
|
|
Current instalments of loans
|
(1,597)
|
-
|
(557)
|
(32)
|
(2,186)
|
Current instalments of leases
|
(188)
|
172
|
(168)
|
1
|
(183)
|
Commercial paper
|
-
|
(793)
|
-
|
-
|
(793)
|
Bank collateral
|
(71)
|
(62)
|
-
|
-
|
(133)
|
Other short-term borrowings excluding overdrafts
|
(8)
|
(3)
|
-
|
(1)
|
(12)
|
Overdraft
|
(146)
|
(137)
|
-
|
5
|
(278)
|
|
|
|
|
|
|
Total current debt
|
(2,010)
|
(823)
|
(725)
|
(27)
|
(3,585)
|
|
|
|
|
|
|
Gross borrowings
|
(18,227)
|
(3,791)
|
(178)
|
(143)
|
(22,339)
|
|
|
|
|
|
|
Net derivative financial instruments
|
43
|
101
|
(13)
|
-
|
131
|
|
|
|
|
|
|
Net borrowings
|
(18,184)
|
(3,690)
|
(191)
|
(143)
|
(22,208)
|
|
|
|
|
|
|
Cash and cash equivalents
|
5,369
|
2,722
|
-
|
(19)
|
8,072
|
Other investments - current
|
849
|
(530)
|
61
|
(6)
|
374
|
Other investments - non-current
|
62
|
-
|
(62)
|
-
|
-
|
Cash and investments
|
6,280
|
2,192
|
(1)
|
(25)
|
8,446
|
|
|
|
|
|
|
Net Debt
|
(11,904)
|
(1,498)
|
(192)
|
(168)
|
(13,762)
|
Non-cash
movements in the period include fair-value adjustments under IFRS
9.
Other
investments - non-current are included within the balance of
$1,173m (31 December 2019: $1,401m) in the Condensed consolidated
statement of financial position. The equivalent GAAP measure to net
debt is ‘liabilities arising from financing
activities’, which excludes the amounts for cash and
overdrafts, other investments and non-financing derivatives shown
above and includes the Acerta Pharma put-option liability of
$2,255m (31 December 2019: $2,146m), shown in non-current other
payables.
Net
Debt increased by $1,858m in the year to date, principally due to
Net cash inflow before financing activities of $2,578m being offset
by the payment of the second interim dividend of 2019 and first
interim dividend of 2020 of $3,572m.
Details
of the committed undrawn bank facilities are disclosed within the
going-concern section of Note 1.
During
the nine months to 30 September 2020, there were no changes to the
Company’s credit ratings issued by Standard and Poor’s
(long term: BBB+, short term A-2) and Moody’s (long term: A3,
short term P-2).
As
detailed in the Group’s most recent annual financial
statements, the principal financial instruments consist of
derivative financial instruments, other investments, trade and
other receivables, cash and cash equivalents, trade and other
payables, leases and interest-bearing loans and borrowings. During
the period, equity investments previously categorised as Level 3 in
the fair-value hierarchy (carrying value of $103m at 31 December
2019) are now categorised as Level 1 (carrying value of $132m at 30
September 2020) on availability of quoted prices in an active
market. There have been no other changes of significance to the
categorisation or fair-value hierarchy classification of financial
instruments from those detailed in the Notes to the Group Financial
Statements in the Annual Report and Form
20-F Information 2019.
The
Group holds certain equity investments that are categorised as
Level 3 in the fair-value hierarchy and for which fair-value gains
of $63m have been recognised in the nine months ended 30 September
2020. All other fair-value gains and/or losses that are presented
in Net gains/(losses) on equity investments measured at fair value
through other comprehensive income in the Condensed consolidated
statement of comprehensive income for the nine months ended 30
September 2020 are Level 1 fair-value measurements.
Financial
instruments measured at fair value include $1,547m of other
investments, $7,024m held in money-market funds, $342m of loans
designated at fair value through profit or loss, $355m of loans
designated in a fair-value hedge relationship and $131m of
derivatives as at 30 September 2020. The total fair value of
interest-bearing loans and borrowings at 30 September 2020, which
have a carrying value of $22,339m in the Condensed consolidated
statement of financial position, was $25,704m.
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 40: Financial instruments - contingent
consideration
|
2020
|
2019
|
Diabetes alliance
|
Other
|
Total
|
Total
|
$m
|
$m
|
$m
|
$m
|
At 1 January
|
3,300
|
839
|
4,139
|
5,106
|
Settlements
|
(394)
|
(269)
|
(663)
|
(487)
|
Revaluations
|
(22)
|
8
|
(14)
|
(13)
|
Discount unwind
|
174
|
38
|
212
|
269
|
|
|
|
|
|
At 30 September
|
3,058
|
616
|
3,674
|
4,875
|
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 $3,058m (31 December 2019: $3,300m)
would increase/decline by $306m with an increase/decline in sales
of 10%, as compared with the current estimates.
Included
within the BMS contingent consideration liability are estimates of
royalties payable in relation to Bydureon. The revised Total Revenue
projections for Bydureon
also resulted in a $22m reduction in the contingent consideration
balance as at 30 September 2020. A further 10% reduction in
Bydureon Total Revenue
would result in an additional $22m reduction.
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 rights, the validity of certain patents,
anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since
publication of the disclosures concerning legal proceedings in the
Company's Annual Report and Form 20-F Information 2019 and H1 2020
results (the Disclosures). Unless noted otherwise below or in the
Disclosures, no provisions have been established in respect of the
claims discussed below.
As
discussed in the Disclosures, for the majority of claims in which
AstraZeneca is involved, it is not possible to make a reasonable
estimate of the expected financial effect, if any, that will result
from ultimate resolution of the proceedings. In these cases,
AstraZeneca discloses information with respect only to the nature
and facts of the cases, but no provision is made.
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 has 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
intellectual property.
Matters disclosed in respect of the third quarter of 2020 and to 5
November 2020
Patent litigation
Enhertu
US patent proceeding
In October 2020, Seagen Inc. 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. AstraZeneca Pharmaceuticals LP
co-commercialises Enhertu
with
Daiichi Sankyo, Inc. in the United States.
Faslodex
Patent proceedings outside the US
As previously disclosed, in Italy, Actavis Group Ptc ehf. and
Actavis Italy S.p.A. filed actions alleging that the Italian part
of European Patent No. EP 1,250,138 (the ‘138 patent) and
European Patent Nos. EP 2,266,573 (the ‘573 patent) are
invalid. In July 2018, the Court of Turin determined that the
‘138 patent is invalid. In July 2019, the Court of Milan
determined that the ‘573 patent is invalid. AstraZeneca
appealed both decisions. In June 2020, the Court of Appeal of Turin
upheld the invalidity decision as to the ‘138 patent. In
August 2020, the Court of Milan denied AstraZeneca’s requests
for a preliminary injunction against Teva Italia
Srl. Patent infringement
and patent-invalidity proceedings are ongoing against various
parties.
As
previously disclosed, in France, in June 2018 the Commercial Court
of Nanterre denied AstraZeneca’s request for a preliminary
injunction against Sandoz SAS (Sandoz) to prevent a potential
launch of its generic Faslodex in France. Additionally, in
June 2018 Sandoz served AstraZeneca
with an invalidation writ against European Patent Nos. EP
2,266,573; EP 1,250,138; and EP 1,272,195. Patent infringement and
patent invalidity proceedings are ongoing with Sandoz. A trial of
the matter is scheduled for November 2020.
Symbicort
US patent proceedings
As
previously disclosed, AstraZeneca initiated ANDA litigation against
Mylan Pharmaceuticals Inc. (Mylan) and 3M Company (3M) in the US
District Court for the Northern District of West Virginia. 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 product does 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. The
trial of the matter was heard in October 2020 and closing argument
is scheduled for January 2021.
Product Liability Litigation
Nexium and Losec/Prilosec
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 scheduled for November 2021. 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.
Commercial litigation
Amplimmune
As
previously disclosed, in June 2017, AstraZeneca was served with a
lawsuit filed by the stockholders' agents for Amplimmune, Inc.
(Amplimmune) in Delaware State Court that alleged, among other
things, breaches of contractual obligations relating to a 2013
merger agreement between AstraZeneca and Amplimmune. Following the
trial of the matter in February 2020, post-trial oral argument was
heard in August 2020. A decision is awaited.
Anti-Terrorism Act Civil Lawsuit
As
previously disclosed, in July 2020, the US District Court for the
District of Columbia granted AstraZeneca’s and certain other
pharmaceutical and/or medical-device companies’ motion and
dismissed a lawsuit filed by US nationals (or their estates,
survivors, or heirs) who were killed or wounded in Iraq between
2005 and 2011, which had alleged that the defendants violated the
US Anti-Terrorism Act and various state laws by selling
pharmaceuticals and medical supplies to the Iraqi Ministry of
Health. The plaintiffs are appealing the District Court’s
order dismissing the litigation.
Definiens
In July 2020, AstraZeneca received a notice of arbitration
filed with the German Institution of Arbitration from the sellers of Definiens AG (Sellers)
regarding the 2014 Share Purchase Agreement (SPA) between
AstraZeneca and the Sellers. The Sellers claim they are owed
approximately $140m in earn-outs under the SPA. AstraZeneca
disputes the claims of the Sellers. The arbitration tribunal has
not yet set a timetable for the arbitration.
Seroquel XR Antitrust
Litigation
As
previously disclosed, in 2019 and 2020, AstraZeneca was named in
several related complaints brought in the US District Court for the
Southern District of New York (the Court), including several
putative class-action lawsuits that were purportedly brought on
behalf of classes of direct purchasers or end payors of
Seroquel XR, that allege
AstraZeneca and generic medicine manufacturers violated antitrust
laws when settling patent litigation related to Seroquel XR. In August 2020, the Court
granted AstraZeneca’s motions to transfer all such lawsuits
to the US District Court for the District of Delaware.
Government investigations/proceedings
Iraqi Ministry of Health Anti-Corruption Probe
As
previously disclosed, in July 2018, AstraZeneca, along with other
companies, received an inquiry from the US Department of Justice
(DOJ) pursuant to the Foreign Corrupt Practices Act in connection
with an anticorruption investigation relating to activities in
Iraq, including interactions with the Iraqi government. In August
2020, the DOJ notified AstraZeneca that it does not intend to
institute an enforcement action and is closing the
inquiry.
Toprol-XL
Louisiana Attorney General Litigation
As
previously disclosed, in July
2020, the Louisiana First Circuit Court of Appeals (the
Appellate Court) reversed and remanded a Louisiana state trial court (the Trial Court)
ruling that had granted AstraZeneca’s motion for
summary judgment and dismissed a state court complaint, brought by
the Attorney General for the State of Louisiana, alleging that
AstraZeneca engaged in unlawful monopolisation and unfair trade
practices in connection with the enforcement of its Toprol-XL patents. In August 2020,
AstraZeneca petitioned the Louisiana Supreme Court to review the
decision of the Appellate Court and reinstate the Trial
Court’s summary judgment ruling. That petition remains
pending.
Taxation
As
previously disclosed in the Annual Report and Form
20-F Information 2019, AstraZeneca faces a number of audits
and reviews in jurisdictions around the world and, in some cases,
is in dispute with the tax authorities. The issues under discussion
are often complex and can require many years to resolve. Accruals
for tax contingencies require management to make key judgements
with respect to the ultimate outcome of current and potential
future tax audits, and actual results could vary from these
estimates. The total net accrual to cover the worldwide tax
exposure for transfer pricing and other international tax
contingencies of $138m (31 December 2019: $140m) reflected the
progress in those tax audits and reviews during the year to date
and for those audits where AstraZeneca and tax authorities are in
dispute, AstraZeneca estimates the potential for reasonably
possible additional liabilities above and beyond the amount
provided to be up to $233m, including associated interest (December
2019: $76m). There was no material change to this estimate in the
quarter. The Company believes, however, that it is unlikely that
these additional liabilities will arise. It is possible that some
of these contingencies may reduce in the future to the extent that
any tax authority challenge is concluded, or matters lapse
following expiry of the relevant statutes of limitation resulting
in a reduction in the tax charge in future periods.
There was no material change in the period to the other tax
contingencies.
In
October 2020, AstraZeneca agreed to sell the commercial rights
to Atacand and Atacand Plus in around 70
countries globally to Cheplapharm , which will pay AstraZeneca
a total of $400m in non-contingent consideration, with $250m
payable on completion and the remainder in the first half of 2021.
The present value of the consideration will be recognised in the
Company’s financial statements within Other Operating Income
and Expense.
In
October 2020, $3.4bn committed bank facilities were extended to
April 2024 (with two additional one-year extension options at
lenders’ discretion). Additionally, in November 2020, further
committed facilities totalling $0.7bn were amended and extended to
November 2021 (with an additional extension option to November 2022
at the Group’s discretion).
46 SAKIGAKE promotes early research and development
in Japan for innovative pharmaceuticals and provides a
rapid-authorisation scheme for unapproved medicines for serious and
life-threatening diseases.
48 Quaque die, or once a
day.
50 Bis in die, or twice a
day.
62 White blood cells
gather in the lining of the oesophagus.
74 Conducted by Direction de la Recherche Clinique et
de l’Innovation L’Assistance Publique - Hôpitaux
de Paris (DRCI AP-HP).
7)
|
Table 41: Product Sales year-on-year analysis - YTD
202078
|
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
3,171
|
38
|
39
|
950
|
72
|
78
|
1,144
|
26
|
503
|
49
|
50
|
574
|
14
|
13
|
Imfinzi
|
1,487
|
42
|
43
|
113
|
n/m
|
n/m
|
885
|
17
|
254
|
n/m
|
n/m
|
235
|
53
|
53
|
Lynparza
|
1,280
|
51
|
53
|
195
|
94
|
n/m
|
631
|
46
|
311
|
50
|
51
|
143
|
34
|
34
|
Calquence
|
340
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
335
|
n/m
|
-
|
-
|
-
|
2
|
n/m
|
n/m
|
Koselugo
|
20
|
n/m
|
n/m
|
-
|
-
|
-
|
20
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex*
|
672
|
9
|
13
|
427
|
12
|
18
|
6
|
17
|
104
|
5
|
6
|
135
|
2
|
2
|
Faslodex*
|
450
|
(38)
|
(37)
|
142
|
(3)
|
3
|
45
|
(85)
|
171
|
2
|
3
|
92
|
(9)
|
(10)
|
Iressa*
|
201
|
(41)
|
(40)
|
163
|
(28)
|
(26)
|
10
|
(25)
|
11
|
(81)
|
(81)
|
17
|
(60)
|
(60)
|
Arimidex*
|
149
|
(14)
|
(11)
|
121
|
3
|
7
|
-
|
-
|
3
|
(88)
|
(88)
|
25
|
(27)
|
(27)
|
Casodex*
|
133
|
(16)
|
(14)
|
104
|
4
|
7
|
1
|
(93)
|
2
|
(84)
|
(84)
|
26
|
(42)
|
(41)
|
Others
|
39
|
(44)
|
(43)
|
20
|
(8)
|
(4)
|
1
|
n/m
|
4
|
(29)
|
(28)
|
14
|
(66)
|
(66)
|
Total Oncology
|
7,942
|
24
|
26
|
2,238
|
34
|
40
|
3,078
|
21
|
1,363
|
33
|
34
|
1,263
|
9
|
8
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
1,373
|
22
|
26
|
488
|
44
|
54
|
385
|
(3)
|
363
|
33
|
34
|
137
|
19
|
19
|
Brilinta
|
1,230
|
7
|
9
|
392
|
13
|
18
|
537
|
7
|
257
|
(2)
|
(1)
|
44
|
2
|
5
|
Onglyza
|
365
|
(8)
|
(6)
|
154
|
18
|
23
|
134
|
(23)
|
43
|
(19)
|
(19)
|
34
|
(10)
|
(9)
|
Bydureon
|
326
|
(21)
|
(20)
|
3
|
(70)
|
(68)
|
278
|
(18)
|
38
|
(24)
|
(23)
|
7
|
(30)
|
(26)
|
Byetta
|
50
|
(40)
|
(38)
|
8
|
1
|
7
|
24
|
(52)
|
11
|
(26)
|
(25)
|
7
|
(19)
|
(17)
|
Other diabetes
|
35
|
(4)
|
(4)
|
5
|
n/m
|
n/m
|
20
|
(30)
|
9
|
35
|
38
|
1
|
56
|
38
|
Lokelma
|
48
|
n/m
|
n/m
|
3
|
n/m
|
n/m
|
37
|
n/m
|
3
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
Crestor*
|
882
|
(10)
|
(8)
|
560
|
(10)
|
(7)
|
71
|
(19)
|
94
|
(16)
|
(15)
|
157
|
(3)
|
(3)
|
Seloken/Toprol-XL*
|
620
|
9
|
14
|
592
|
15
|
21
|
9
|
(69)
|
12
|
(37)
|
(37)
|
7
|
(12)
|
(7)
|
Atacand*
|
180
|
11
|
18
|
133
|
14
|
21
|
7
|
(11)
|
22
|
-
|
-
|
18
|
24
|
27
|
Others
|
145
|
(27)
|
(26)
|
93
|
(33)
|
(31)
|
-
|
-
|
45
|
(2)
|
(1)
|
7
|
(55)
|
(54)
|
BioPharmaceuticals: total CVRM
|
5,254
|
3
|
5
|
2,431
|
9
|
15
|
1,502
|
(7)
|
897
|
5
|
6
|
424
|
2
|
3
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
2,042
|
15
|
16
|
423
|
6
|
11
|
755
|
29
|
521
|
3
|
4
|
343
|
18
|
20
|
Fasenra
|
666
|
34
|
34
|
10
|
n/m
|
n/m
|
423
|
23
|
140
|
72
|
74
|
93
|
34
|
34
|
Pulmicort
|
628
|
(40)
|
(39)
|
479
|
(43)
|
(42)
|
53
|
(40)
|
55
|
(8)
|
(6)
|
41
|
(32)
|
(32)
|
Daliresp/Daxas
|
163
|
4
|
4
|
3
|
(12)
|
(9)
|
141
|
6
|
18
|
(7)
|
(6)
|
1
|
(8)
|
(6)
|
Bevespi
|
36
|
19
|
19
|
1
|
n/m
|
n/m
|
33
|
11
|
2
|
n/m
|
n/m
|
-
|
-
|
-
|
Breztri
|
21
|
n/m
|
n/m
|
14
|
n/m
|
n/m
|
3
|
n/m
|
-
|
-
|
-
|
4
|
n/m
|
n/m
|
Others
|
273
|
(17)
|
(16)
|
122
|
(27)
|
(25)
|
8
|
n/m
|
132
|
(12)
|
(11)
|
11
|
(5)
|
(2)
|
BioPharmaceuticals: total Respiratory & Immunology
|
3,829
|
(1)
|
1
|
1,052
|
(26)
|
(23)
|
1,416
|
20
|
868
|
6
|
7
|
493
|
14
|
15
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium*
|
1,115
|
(1)
|
1
|
563
|
(2)
|
2
|
127
|
(28)
|
59
|
21
|
21
|
366
|
10
|
10
|
Synagis*
|
294
|
-
|
-
|
-
|
-
|
-
|
47
|
29
|
247
|
(5)
|
(5)
|
-
|
-
|
-
|
Losec/Prilosec*
|
144
|
(34)
|
(32)
|
119
|
(18)
|
(16)
|
3
|
(50)
|
17
|
(63)
|
(63)
|
5
|
(74)
|
(75)
|
FluMist*
|
116
|
n/m
|
n/m
|
-
|
-
|
-
|
65
|
n/m
|
49
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
Seroquel XR/IR*
|
98
|
(35)
|
(34)
|
41
|
(2)
|
1
|
22
|
(19)
|
21
|
(68)
|
(68)
|
14
|
(7)
|
(8)
|
Others
|
87
|
(35)
|
(35)
|
6
|
45
|
42
|
38
|
(53)
|
38
|
(15)
|
(15)
|
5
|
3
|
3
|
Total other medicines
|
1,854
|
(5)
|
(4)
|
729
|
(5)
|
(1)
|
302
|
(13)
|
431
|
(7)
|
(8)
|
392
|
5
|
5
|
Total Product Sales
|
18,879
|
9
|
11
|
6,450
|
6
|
11
|
6,298
|
11
|
3,559
|
12
|
13
|
2,572
|
8
|
8
|
8)
|
Table
42: Product Sales year-on-year analysis - Q3 202079
|
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
1,155
|
30
|
30
|
355
|
59
|
61
|
419
|
20
|
178
|
42
|
37
|
203
|
6
|
5
|
Imfinzi
|
533
|
29
|
29
|
50
|
n/m
|
n/m
|
311
|
9
|
87
|
59
|
55
|
85
|
30
|
29
|
Lynparza
|
464
|
42
|
42
|
75
|
79
|
88
|
224
|
32
|
114
|
48
|
44
|
51
|
33
|
33
|
Calquence
|
145
|
n/m
|
n/m
|
2
|
91
|
115
|
142
|
n/m
|
-
|
-
|
-
|
1
|
n/m
|
n/m
|
Koselugo
|
13
|
n/m
|
n/m
|
-
|
-
|
-
|
13
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
Zoladex*
|
230
|
2
|
3
|
139
|
(4)
|
(1)
|
1
|
(1)
|
36
|
4
|
3
|
54
|
18
|
17
|
Faslodex*
|
138
|
(33)
|
(32)
|
41
|
(16)
|
(11)
|
12
|
(81)
|
54
|
(6)
|
(8)
|
31
|
(19)
|
(19)
|
Iressa*
|
54
|
(41)
|
(40)
|
43
|
(31)
|
(30)
|
3
|
(50)
|
3
|
(83)
|
(83)
|
5
|
(30)
|
(33)
|
Arimidex*
|
42
|
(34)
|
(32)
|
32
|
(31)
|
(29)
|
-
|
-
|
1
|
(83)
|
(84)
|
9
|
(15)
|
(15)
|
Casodex*
|
44
|
(16)
|
(16)
|
34
|
-
|
2
|
1
|
n/m
|
1
|
(79)
|
(84)
|
8
|
(42)
|
(39)
|
Others
|
13
|
(39)
|
(36)
|
6
|
8
|
22
|
1
|
n/m
|
1
|
(45)
|
(47)
|
5
|
(60)
|
(61)
|
Total Oncology
|
2,831
|
21
|
22
|
777
|
26
|
30
|
1,127
|
23
|
475
|
26
|
23
|
452
|
7
|
6
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
525
|
32
|
35
|
181
|
37
|
47
|
148
|
18
|
141
|
48
|
44
|
55
|
27
|
26
|
Brilinta
|
385
|
(7)
|
(7)
|
102
|
(22)
|
(20)
|
185
|
3
|
84
|
(8)
|
(11)
|
14
|
(5)
|
(5)
|
Onglyza
|
109
|
(14)
|
(13)
|
55
|
24
|
27
|
29
|
(47)
|
14
|
(18)
|
(19)
|
11
|
(1)
|
1
|
Bydureon
|
110
|
(14)
|
(14)
|
1
|
(55)
|
(51)
|
93
|
(13)
|
14
|
(14)
|
(16)
|
2
|
(7)
|
(3)
|
Byetta
|
15
|
(46)
|
(44)
|
3
|
(12)
|
(8)
|
6
|
(66)
|
3
|
(28)
|
(22)
|
3
|
(3)
|
(12)
|
Other diabetes
|
11
|
(19)
|
(20)
|
1
|
n/m
|
n/m
|
6
|
(44)
|
3
|
23
|
21
|
1
|
n/m
|
n/m
|
Lokelma
|
21
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
16
|
n/m
|
1
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
Crestor*
|
300
|
(11)
|
(10)
|
191
|
(11)
|
(9)
|
26
|
(23)
|
30
|
(18)
|
(19)
|
53
|
1
|
-
|
Seloken/Toprol-XL*
|
225
|
27
|
32
|
216
|
31
|
36
|
3
|
(17)
|
4
|
(30)
|
(30)
|
2
|
(30)
|
(25)
|
Atacand*
|
54
|
(2)
|
4
|
39
|
(5)
|
4
|
2
|
13
|
7
|
6
|
6
|
6
|
3
|
1
|
Others
|
39
|
(41)
|
(41)
|
28
|
(36)
|
(38)
|
-
|
-
|
10
|
(37)
|
(36)
|
1
|
(91)
|
(79)
|
BioPharmaceuticals: total CVRM
|
1,794
|
3
|
4
|
819
|
5
|
10
|
514
|
(4)
|
311
|
6
|
4
|
150
|
5
|
5
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
599
|
(2)
|
(2)
|
132
|
(4)
|
1
|
197
|
(3)
|
165
|
7
|
4
|
105
|
(11)
|
(11)
|
Fasenra
|
240
|
19
|
18
|
3
|
12
|
26
|
151
|
11
|
52
|
43
|
39
|
34
|
24
|
23
|
Pulmicort
|
151
|
(55)
|
(55)
|
109
|
(60)
|
(59)
|
17
|
(49)
|
14
|
(8)
|
(12)
|
11
|
(44)
|
(45)
|
Daliresp/Daxas
|
57
|
8
|
9
|
1
|
(10)
|
(13)
|
51
|
15
|
5
|
(30)
|
(33)
|
-
|
-
|
-
|
Bevespi
|
14
|
38
|
36
|
1
|
-
|
-
|
12
|
23
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
Breztri
|
10
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
3
|
n/m
|
-
|
-
|
-
|
2
|
31
|
37
|
Others
|
90
|
(12)
|
(13)
|
42
|
(20)
|
(20)
|
1
|
(52)
|
44
|
(3)
|
(5)
|
3
|
(16)
|
(15)
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,161
|
(12)
|
(12)
|
293
|
(37)
|
(35)
|
432
|
1
|
281
|
9
|
6
|
155
|
(9)
|
(9)
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium*
|
401
|
7
|
9
|
193
|
(6)
|
(2)
|
47
|
(17)
|
22
|
34
|
25
|
139
|
45
|
45
|
Synagis*
|
118
|
(19)
|
(19)
|
(5)
|
-
|
-
|
26
|
n/m
|
97
|
(33)
|
(33)
|
-
|
-
|
-
|
Losec/Prilosec*
|
45
|
(38)
|
(38)
|
38
|
(23)
|
(24)
|
-
|
(83)
|
7
|
(50)
|
(52)
|
-
|
(98)
|
(97)
|
FluMist*
|
116
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
65
|
n/m
|
49
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
Seroquel XR/IR*
|
35
|
(57)
|
(56)
|
13
|
(22)
|
(19)
|
8
|
(81)
|
7
|
(66)
|
(65)
|
7
|
70
|
69
|
Others
|
19
|
(56)
|
(57)
|
3
|
n/m
|
n/m
|
5
|
(85)
|
10
|
(41)
|
(46)
|
1
|
n/m
|
n/m
|
Total other medicines
|
734
|
1
|
1
|
242
|
(9)
|
(6)
|
151
|
5
|
192
|
(10)
|
(12)
|
149
|
38
|
38
|
Total Product Sales
|
6,520
|
6
|
7
|
2,131
|
-
|
4
|
2,224
|
10
|
1,259
|
10
|
8
|
906
|
7
|
7
|
9)
|
Table
43: Product Sales quarterly sequential analysis - 202080
|
|
Q1 2020
|
Q2 2020
|
Q3 2020
|
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
982
|
11
|
11
|
1,034
|
5
|
7
|
1,155
|
12
|
9
|
|
Imfinzi
|
462
|
9
|
9
|
492
|
6
|
8
|
533
|
8
|
6
|
|
Lynparza
|
397
|
13
|
13
|
419
|
5
|
7
|
464
|
11
|
8
|
|
Calquence
|
88
|
58
|
58
|
107
|
21
|
23
|
145
|
36
|
35
|
|
Koselugo
|
-
|
-
|
-
|
7
|
n/m
|
n/m
|
13
|
75
|
75
|
|
Zoladex*
|
225
|
15
|
15
|
217
|
(3)
|
-
|
230
|
6
|
3
|
|
Faslodex*
|
166
|
-
|
-
|
146
|
(12)
|
(9)
|
138
|
(5)
|
(8)
|
|
Iressa*
|
77
|
(3)
|
(4)
|
70
|
(9)
|
(7)
|
54
|
(23)
|
(24)
|
|
Arimidex*
|
50
|
(1)
|
(2)
|
58
|
17
|
16
|
42
|
(28)
|
(27)
|
|
Casodex*
|
42
|
(2)
|
(3)
|
47
|
14
|
12
|
44
|
(7)
|
(8)
|
|
Others
|
13
|
(52)
|
(52)
|
12
|
(11)
|
(1)
|
13
|
4
|
3
|
|
Total Oncology
|
2,502
|
10
|
10
|
2,609
|
4
|
6
|
2,831
|
8
|
6
|
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
405
|
(3)
|
(3)
|
443
|
9
|
13
|
525
|
19
|
16
|
|
Brilinta
|
408
|
(5)
|
(5)
|
437
|
7
|
9
|
385
|
(12)
|
(13)
|
|
Onglyza
|
141
|
8
|
8
|
115
|
(19)
|
(17)
|
110
|
(6)
|
(6)
|
|
Bydureon
|
100
|
(28)
|
(28)
|
116
|
16
|
17
|
109
|
(5)
|
(7)
|
|
Byetta
|
20
|
(24)
|
(24)
|
15
|
(28)
|
(28)
|
15
|
1
|
4
|
|
Other diabetes
|
13
|
(22)
|
(22)
|
10
|
(21)
|
(19)
|
11
|
9
|
6
|
|
Lokelma
|
11
|
42
|
42
|
17
|
56
|
58
|
21
|
22
|
26
|
|
Crestor*
|
301
|
2
|
1
|
281
|
(7)
|
(4)
|
300
|
7
|
5
|
|
Seloken/Toprol-XL*
|
177
|
(6)
|
(6)
|
218
|
23
|
27
|
225
|
4
|
3
|
|
Atacand*
|
66
|
11
|
12
|
59
|
(11)
|
(5)
|
54
|
(9)
|
(12)
|
|
Others
|
59
|
(21)
|
(22)
|
48
|
(18)
|
(16)
|
39
|
(19)
|
(22)
|
|
BioPharmaceuticals: total CVRM
|
1,701
|
(5)
|
(5)
|
1,759
|
3
|
6
|
1,794
|
2
|
-
|
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
790
|
11
|
11
|
653
|
(17)
|
(15)
|
599
|
(8)
|
(11)
|
|
Fasenra
|
199
|
(3)
|
(3)
|
227
|
14
|
15
|
240
|
5
|
4
|
|
Pulmicort
|
380
|
(8)
|
(9)
|
97
|
(74)
|
(73)
|
151
|
56
|
49
|
|
Daliresp/Daxas
|
53
|
(8)
|
(8)
|
53
|
(1)
|
(3)
|
57
|
8
|
11
|
|
Bevespi
|
12
|
9
|
9
|
10
|
(19)
|
(21)
|
14
|
47
|
46
|
|
Breztri
|
4
|
n/m
|
n/m
|
7
|
58
|
64
|
10
|
45
|
48
|
|
Others
|
113
|
(16)
|
(17)
|
70
|
(38)
|
(36)
|
90
|
27
|
22
|
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,551
|
1
|
1
|
1,117
|
(28)
|
(26)
|
1,161
|
4
|
1
|
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
Nexium*
|
338
|
(4)
|
(4)
|
377
|
12
|
14
|
401
|
6
|
4
|
|
Synagis*
|
85
|
35
|
35
|
90
|
6
|
7
|
118
|
31
|
29
|
|
Losec/Prilosec*
|
54
|
18
|
17
|
45
|
(15)
|
(15)
|
45
|
-
|
-
|
|
FluMist*
|
-
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
116
|
n/m
|
n/m
|
|
Seroquel XR/IR*
|
36
|
(12)
|
(12)
|
27
|
(26)
|
(23)
|
35
|
32
|
29
|
|
Others
|
44
|
(71)
|
(70)
|
24
|
(46)
|
(42)
|
19
|
(17)
|
(19)
|
|
Total other medicines
|
557
|
(15)
|
(15)
|
563
|
1
|
4
|
734
|
30
|
27
|
|
Total Product Sales
|
6,311
|
1
|
1
|
6,048
|
(4)
|
(2)
|
6,520
|
8
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
10)
|
Table
44: Product Sales quarterly sequential analysis - 201981
|
|
Q1 2019
|
Q2 2019
|
Q3 2019
|
Q4 2019
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
630
|
6
|
6
|
784
|
24
|
25
|
891
|
14
|
13
|
884
|
(1)
|
-
|
Imfinzi
|
295
|
13
|
13
|
338
|
15
|
15
|
412
|
22
|
22
|
424
|
3
|
4
|
Lynparza
|
237
|
13
|
13
|
283
|
19
|
20
|
327
|
16
|
15
|
351
|
7
|
8
|
Calquence
|
29
|
21
|
23
|
35
|
21
|
19
|
44
|
27
|
27
|
56
|
25
|
25
|
Faslodex*
|
254
|
(6)
|
(6)
|
267
|
5
|
6
|
205
|
(23)
|
(23)
|
166
|
(20)
|
(19)
|
Zoladex*
|
194
|
7
|
6
|
197
|
2
|
1
|
226
|
15
|
16
|
196
|
(14)
|
(12)
|
Iressa*
|
134
|
20
|
18
|
118
|
(12)
|
(11)
|
91
|
(23)
|
(22)
|
80
|
(13)
|
(12)
|
Arimidex*
|
51
|
11
|
10
|
60
|
18
|
17
|
63
|
5
|
5
|
51
|
(20)
|
(18)
|
Casodex*
|
48
|
4
|
3
|
57
|
19
|
18
|
52
|
(8)
|
(6)
|
43
|
(18)
|
(17)
|
Others
|
20
|
(13)
|
(14)
|
28
|
40
|
29
|
20
|
(27)
|
(22)
|
26
|
30
|
26
|
Total Oncology
|
1,892
|
7
|
6
|
2,167
|
15
|
15
|
2,334
|
8
|
8
|
2,274
|
(3)
|
(2)
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
349
|
(12)
|
(12)
|
377
|
8
|
9
|
398
|
5
|
5
|
419
|
5
|
6
|
Brilinta
|
348
|
(7)
|
(8)
|
389
|
12
|
12
|
416
|
7
|
8
|
428
|
3
|
3
|
Onglyza
|
153
|
3
|
3
|
116
|
(24)
|
(24)
|
127
|
9
|
11
|
131
|
3
|
4
|
Bydureon
|
142
|
3
|
3
|
141
|
(1)
|
-
|
127
|
(10)
|
(10)
|
139
|
9
|
10
|
Byetta
|
30
|
(6)
|
(5)
|
25
|
(17)
|
(16)
|
28
|
10
|
13
|
27
|
(2)
|
(4)
|
Other diabetes
|
11
|
(8)
|
(17)
|
11
|
-
|
8
|
14
|
26
|
22
|
16
|
17
|
17
|
Lokelma
|
-
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
8
|
87
|
74
|
Crestor*
|
335
|
(5)
|
(6)
|
310
|
(7)
|
(7)
|
337
|
9
|
9
|
296
|
(12)
|
(11)
|
Seloken/Toprol-XL*
|
225
|
41
|
38
|
168
|
(25)
|
(25)
|
177
|
6
|
8
|
190
|
7
|
8
|
Atacand*
|
50
|
(14)
|
(15)
|
56
|
12
|
14
|
55
|
(1)
|
(1)
|
60
|
8
|
9
|
Others
|
71
|
(3)
|
(5)
|
63
|
(11)
|
(8)
|
65
|
4
|
2
|
72
|
13
|
16
|
BioPharmaceuticals: total CVRM
|
1,714
|
(2)
|
(3)
|
1,658
|
(3)
|
(3)
|
1,749
|
5
|
6
|
1,785
|
2
|
3
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
585
|
(8)
|
(8)
|
585
|
-
|
1
|
613
|
5
|
4
|
712
|
16
|
17
|
Pulmicort
|
383
|
(2)
|
(2)
|
333
|
(13)
|
(13)
|
337
|
1
|
3
|
413
|
22
|
23
|
Fasenra
|
129
|
3
|
4
|
167
|
29
|
30
|
202
|
21
|
21
|
206
|
2
|
2
|
Daliresp/Daxas
|
48
|
(11)
|
(12)
|
56
|
17
|
18
|
53
|
(6)
|
(7)
|
58
|
10
|
10
|
Bevespi
|
10
|
-
|
(5)
|
10
|
-
|
2
|
10
|
4
|
8
|
12
|
8
|
5
|
Breztri
|
-
|
-
|
-
|
-
|
-
|
-
|
1
|
-
|
-
|
1
|
(74)
|
(73)
|
Others
|
128
|
(14)
|
(12)
|
101
|
(21)
|
(23)
|
102
|
1
|
(1)
|
135
|
33
|
38
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,283
|
(6)
|
(6)
|
1,252
|
(2)
|
(2)
|
1,319
|
5
|
6
|
1,537
|
17
|
17
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium*
|
363
|
(7)
|
(8)
|
393
|
8
|
8
|
374
|
(5)
|
(4)
|
353
|
(6)
|
(6)
|
Synagis*
|
53
|
(79)
|
(79)
|
96
|
81
|
81
|
146
|
52
|
53
|
63
|
(57)
|
(57)
|
Losec/Prilosec*
|
76
|
27
|
26
|
68
|
(11)
|
(10)
|
73
|
8
|
9
|
46
|
(38)
|
(38)
|
Seroquel XR/IR*
|
37
|
(34)
|
(33)
|
32
|
(14)
|
(10)
|
82
|
n/m
|
n/m
|
40
|
(50)
|
(49)
|
Others
|
47
|
(65)
|
(64)
|
52
|
11
|
11
|
56
|
8
|
-
|
151
|
n/m
|
n/m
|
Total other medicines
|
576
|
(35)
|
(36)
|
641
|
11
|
12
|
731
|
14
|
14
|
653
|
(11)
|
(10)
|
Total Product Sales
|
5,465
|
(5)
|
(6)
|
5,718
|
5
|
5
|
6,132
|
7
|
8
|
6,250
|
2
|
3
|
80 The table provides an analysis of sequential
quarterly Product Sales, with actual and CER growth rates
reflecting quarter-on-quarter growth. Due to rounding, the sum of a
number of dollar values and percentages may not agree to totals.
*Denotes a legacy medicine.
81 The table below 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 45: Historic Collaboration Revenue
|
|
YTD 2020
|
YTD 2019
|
FY 2019
|
FY 2018
|
$m
|
$m
|
$m
|
$m
|
Initial Collaboration Revenue
|
Crestor (Spain)
|
-
|
-
|
-
|
61
|
Ongoing Collaboration Revenue
|
Lynparza: regulatory
milestones
|
135
|
60
|
60
|
140
|
Lynparza: sales
milestones
|
-
|
200
|
450
|
250
|
Lynparza/selumetinib: option
payments
|
-
|
-
|
100
|
400
|
Crestor (Spain)
|
-
|
-
|
39
|
-
|
Enhertu: profit
share
|
63
|
-
|
-
|
-
|
Roxadustat: profit share
|
19
|
-
|
-
|
-
|
Royalty income
|
47
|
42
|
62
|
49
|
|
Other Collaboration Revenue
|
64
|
103
|
108
|
141
|
Total
|
328
|
405
|
819
|
1,041
|
Table 46: Other Operating Income and Expense
The
table below provides an analysis of Reported Other Operating Income
and Expense.
|
YTD 2020
|
YTD 2019
|
FY 2019
|
FY 2018
|
$m
|
$m
|
$m
|
$m
|
Hypertension medicines (ex-US, India and Japan)
|
350
|
-
|
-
|
-
|
Monetisation of an asset previously licensed
|
120
|
-
|
-
|
-
|
Brazikumab licence termination funding
|
51
|
-
|
-
|
-
|
Inderal, Tenormin, Seloken and Omepral (Japan)
|
51
|
-
|
-
|
-
|
Synagis (US)
|
-
|
515
|
515
|
-
|
Losec (ex-China, Japan, US and
Mexico)
|
-
|
243
|
243
|
-
|
Seroquel and Seroquel XR (US,
Canada, Europe and Russia)
|
-
|
-
|
213
|
-
|
Arimidex and
Casodex
(various
countries)
|
-
|
-
|
181
|
-
|
Nexium (Europe) and
Vimovo
(ex-US)
|
-
|
-
|
-
|
728
|
Seroquel
|
-
|
-
|
-
|
527
|
Legal settlement
|
-
|
-
|
-
|
346
|
Atacand
|
-
|
-
|
-
|
210
|
Anaesthetics
|
-
|
-
|
-
|
172
|
Alvesco, Omnaris and Zetonna
|
-
|
-
|
-
|
139
|
Other
|
316
|
283
|
389
|
405
|
Total
|
888
|
1,041
|
1,541
|
2,527
|
Shareholder information
Announcement of
full year and fourth quarter results
|
11
February 2021
|
Announcement of
first quarter results
|
30
April 2021
|
Announcement of
half year and second quarter results
|
29 July
2021
|
Announcement of
year to date and third quarter results
|
12
November 2021
|
|
Dividends are
normally be paid as follows:
|
First
interim:
|
announced
with the half year and fourth quarter results and paid in
March
|
Second
interim:
|
announced
with full year and fourth quarter results and paid in
March
|
The
record date for the second interim dividend for 2020, payable on 29
March 2021, will be 26 February 2021. The ex-dividend date will be
25 February 2021.
Trademarks
of the AstraZeneca group of companies appear throughout this
document in italics. Medical publications also appear throughout
the document in italics. AstraZeneca, the AstraZeneca logotype and
the AstraZeneca symbol are all trademarks of the AstraZeneca group
of companies. Trademarks of companies other than AstraZeneca that
appear in this document include Alvesco, Omnaris and Zetonna, trademarks of Covis Pharma;
Arimidex and Casodex, owned by AstraZeneca or
Juvisé (depending on geography); Atacand, owned by AstraZeneca or
Cheplapharm (depending on geography); Avastin, a trademark of Genentech, Inc.;
Equidacent, a trademark of
Centus Biotherapeutics; Broncho-Vaxom, a trademark of OM Pharma
SA; Duaklir, Eklira and Tudorza, trademarks of Almirall, S.A.;
Enhertu, a trademark of
Daiichi Sankyo; Inderal,
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); Zestril, owned by AstraZeneca or Atnahs
Pharma (depending upon 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 intellectual property (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
-
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
-
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
-
and the impact that
the COVID-19 global pandemic may have or continue to have on these
risks, on the Group’s ability to continue to mitigate these
risks, and on the Group’s operations, financial results or
financial condition
Nothing
in this document, or any related presentation/webcast, should be
construed as a profit forecast.
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:
05 November
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Aug 2024 to Sep 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Sep 2023 to Sep 2024