Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of February
2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZN: Full-year and
Q4 2019 results
AstraZeneca PLC
14 February 2020 7:00 GMT
Full-year and Q4 2019 results
A year of significant innovation for patients; accelerating the
strategic transition
AstraZeneca delivered a year of strong revenue growth, supported by
the launch of new medicines1 and
further good progress on its pipeline, with several approvals and
data readouts. These trends are set to continue in 2020,
accompanied by growth in earnings and cash. In maintaining its
focus on patients and science, the Company remains on track to
deliver its strategic ambitions.
Full-year Product Sales growth of 12% (15% at
CER2)
to $23,565m included fourth-quarter Product Sales of $6,250m (+8%,
+9% at CER). All three therapy areas and every sales region grew at
CER in the quarter and over the full year. Highlights for the year
included:
- Sales
of new medicines increased by 59% (62% at CER) to $9,906m,
including new-medicine growth in Emerging Markets of 75% (84% at
CER) to $1,865m. New medicines represented 42% of total Product
Sales (FY 2018: 30%)
- Sales growth across the
therapy areas: Oncology +44% (+47% at CER) to $8,667m, New
CVRM3 +9%
(+12% at CER) to $4,376m and Respiratory +10% (+13% at CER) to
$5,391m
- For the first time,
around half of Product Sales in the year were within the
specialty-care4 setting
- Sales
growth across regions: total Emerging Markets sales increased by
18% (24% at CER) to $8,165m, with China sales growth of 29% (35% at
CER); China sales in the quarter increased by 25% (28% at CER) to
$1,189m. US sales increased by 13% in the year to $7,747m; Europe
sales declined by 2% in the year (up by 2% at CER) to $4,350m;
Japan sales increased by 27% (26% at CER) to $2,548m
|
|
FY 2019
|
Q4 2019
|
|
|
$m
|
% change
|
$m
|
% change
|
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Product Sales
|
23,565
|
12
|
15
|
6,250
|
8
|
9
|
|
Collaboration Revenue
|
819
|
(21)
|
(20)
|
414
|
(36)
|
(36)
|
|
Total Revenue
|
24,384
|
10
|
13
|
6,664
|
4
|
5
|
|
|
|
|
|
|
|
|
|
Reported5 Operating
Profit
|
2,924
|
(14)
|
(16)
|
577
|
(46)
|
(56)
|
|
Core6 Operating Profit
|
6,436
|
13
|
13
|
1,545
|
(29)
|
(33)
|
|
|
|
|
|
|
|
|
|
Reported EPS7
|
$1.03
|
(40)
|
(44)
|
$0.24
|
(71)
|
(78)
|
|
Core EPS
|
$3.50
|
1
|
-
|
$0.89
|
(44)
|
(46)
|
Pascal Soriot, Chief Executive Officer, commenting on the results
said:
"In the first full year of our return to growth, we made good
progress in line with our strategy. Results from our new medicines
and Emerging Markets accompanied positive news for patients, most
recently including regulatory approvals of Enhertu in breast cancer
and Calquence in
leukaemia. Our collaborations also progressed at pace, including
that with Daiichi Sankyo, while there were several regulatory
approvals for new medicines in China at the end of the year, such
as Lynparza in first-line ovarian
cancer.
Driven by a strong team, 2020 is anticipated to be another year of
progress for AstraZeneca. We are becoming a better-balanced
business, both regionally and through our medicines. This
transition is a further step towards improving operating leverage
and cash generation. As we accelerate our commitments to achieving
our long-term climate-change and decarbonisation targets, we will
maintain our focus on executing a strategy centred on science and
patients."
Guidance
The Company provides guidance for FY 2020 at CER; Company guidance
is on:
- Total
Revenue, comprising Product Sales and Collaboration
Revenue
- Core
EPS
Prior guidance was on Product Sales and Core EPS. The change to
guiding on Total Revenue and Core EPS reflects the changing nature
and growing strategic impact of Collaboration Revenue, which will
primarily comprise potential income from existing collaborations as
follows:
- A share of gross
profits derived from sales of Enhertu (trastuzumab deruxtecan) in several markets,
where those sales are recorded by Daiichi Sankyo Company, Limited
(Daiichi Sankyo)
- A share of gross
profits derived from sales of roxadustat in China, recorded by
FibroGen Inc. (FibroGen)8
- Milestone revenue
from the MSD9 collaboration
on Lynparza and selumetinib
- Smaller
amounts of milestone and royalty revenue from other marketed and
pipeline medicines
All guidance assumes an unfavourable impact from China lasting up
to a few months as a result of the recent novel coronavirus
(Covid-19) outbreak. The Company will monitor closely the
development of the epidemic and anticipates providing an update at
the time of the Q1 2020 results.
Depending on the impact of the Covid-19 epidemic, Total Revenue is
expected to increase by a high single-digit to a low double-digit
percentage and Core EPS is expected to increase by a mid- to
high-teens percentage.
Variations in performance between quarters can be expected to
continue. The Company is unable to provide guidance and indications
on a Reported basis because the Company cannot reliably forecast
material elements of the Reported result, including any fair-value
adjustments arising on acquisition-related liabilities, intangible
asset impairment charges and legal-settlement provisions. Please
refer to the section Cautionary Statements Regarding
Forward-Looking Statements at the end of this
announcement.
Indications
The Company provides indications for FY 2020 at CER:
- The
Company is focused on improving operating leverage
- A
Core Tax Rate of 18-22%. Variations in the Core Tax Rate between
quarters are anticipated to continue
- Capital
Expenditure is expected to be broadly stable versus the prior
year
Currency impact
If foreign-exchange rates for February to December 2020 were to
remain at the average of rates seen in January 2020, it is
anticipated that there would be a neutral impact on Total Revenue
and a low single-digit adverse impact on Core EPS, versus the prior
year. In addition, the Company's foreign-exchange rate sensitivity
analysis is contained within the operating and financial
review.
Financial summary
-
Product Sales increased by 12% in the year (15% at CER) to
$23,565m, driven by the performances of new medicines and Emerging
Markets
-
The Reported Gross Profit Margin increased by three percentage
points in the year (two at CER) to 79%, partly reflecting the mix
of sales; the Core Gross Profit Margin was stable at 80%. The
performance came despite the impact of a provision
regarding Epanova for inventory and
supply-related costs of $115m, recorded in Reported and Core Cost
of Sales
-
Reported Operating Expense increased by 11% in the year (14% at CER) to
$18,080m and represented 74% of Total Revenue (FY 2018:
74%); part of the rise reflected an
increased level of intangible asset impairments. Core
Operating Expense increased by 4%
(7% at CER) to $14,748m and represented 60% of Total
Revenue (FY 2018: 64%); the increase was driven by investment in
the launches of new medicines and in Emerging Markets
- The
Reported Operating Profit Margin declined in the year by three
percentage points (four at CER) to 12%; the Core Operating Profit
Margin increased by one percentage point (stable at CER) to
26%
-
Reported EPS of $1.03 in the year, based on a weighted-average
number of shares of 1,301m, represented a decline of 40% (44% at
CER); Core EPS increased by 1% (stable at CER) to
$3.50
-
The Board has reaffirmed its commitment to the progressive dividend
policy; a second interim dividend of $1.90 per share has been
declared, taking the unchanged full-year dividend per share to
$2.80
Commercial summary
Oncology
Sales
increased by 44% in the year (47% at CER) to $8,667m,
including:
Table 1: Select Oncology sales
|
|
FY 2019
|
Q4 2019
|
|
|
$m
|
% change
|
$m
|
% change
|
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Tagrisso
|
3,189
|
71
|
74
|
884
|
49
|
49
|
|
Imfinzi
|
1,469
|
n/m
|
n/m
|
424
|
62
|
62
|
|
Lynparza
|
1,198
|
85
|
89
|
351
|
68
|
69
|
|
Calquence
|
164
|
n/m
|
n/m
|
56
|
n/m
|
n/m
|
The strong Oncology performance continued to benefit from new
medicines such as Tagrisso,
Lynparza and Imfinzi. The full impact of recent regulatory approvals
for Calquence and Enhertu is anticipated to favourably affect Total
Revenue growth in 2020.
The performance from legacy Oncology medicines in the year included
a decline in Faslodex sales of 13% (11% at CER) to $892m; the fall
in the fourth quarter of 39% (38% at CER) led to sales
of Faslodex of $166m. These declines reflected the 2019
launch of multiple generic Faslodex medicines in the
US. Iressa sales
also declined in the year by 18% (15% at CER) to $423m and in the
quarter by 29% (28% at CER) to $80m; Iressa continued to be included on the
China volume-based procurement programme in the year. The
Company anticipates continued declines for both
medicines.
Oncology sales increased in Emerging Markets by 45% (52% at CER) to
$2,211m.
New CVRM
Sales
increased by 9% in the year (12% at CER) to $4,376m,
including:
Table 2: Select New CVRM sales
|
|
FY 2019
|
Q4 2019
|
|
|
$m
|
% change
|
$m
|
% change
|
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Farxiga
|
1,543
|
11
|
14
|
419
|
6
|
7
|
|
Brilinta
|
1,581
|
20
|
23
|
428
|
14
|
15
|
|
Bydureon
|
549
|
(6)
|
(5)
|
139
|
1
|
1
|
The Company anticipates reporting on roxadustat sales within Total
Revenue in due course.
New CVRM sales increased in Emerging Markets by 33% in the year
(41% at CER) to $1,133m.
Respiratory
Sales
increased by 10% in the year (13% at CER) to $5,391m,
including:
Table 3: Select Respiratory sales
|
|
FY 2019
|
Q4 2019
|
|
|
$m
|
% change
|
$m
|
% change
|
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Symbicort
|
2,495
|
(3)
|
-
|
712
|
12
|
13
|
|
Pulmicort
|
1,466
|
14
|
18
|
413
|
6
|
7
|
|
Fasenra
|
704
|
n/m
|
n/m
|
206
|
65
|
65
|
Respiratory sales increased in Emerging Markets by 21% (27% at CER)
to $1,987m.
Emerging Markets
As the
Company's largest region, at 35% of total Product Sales, Emerging
Markets sales increased by 18% in the year (24% at CER) to $8,165m,
including:
- A
China sales increase of 29% (35% at CER) to
$4,880m
-
An ex-China sales increase of 6% (12% at CER) to
$3,285m
Sustainability summary
Recent developments and progress against the Company's
sustainability priorities are reported below:
- Access to healthcare:
the Company announced that the Young Health Programme (YHP) will
partner with UNICEF10 to
prevent non-communicable diseases among young people. AstraZeneca
and UNICEF will collaborate on initiatives that will reach more
than five million young people, train c.1,000 youth advocates, and
potentially help to shape public policy around the world over the
next six years
-
Environmental protection: AstraZeneca recently unveiled an
ambitious programme for zero-carbon emissions from its global
operations by 2025 and a carbon-negative value chain by 2030. The
strategy brings forward decarbonisation plans by more than a
decade. In 2019, the Company was ranked 56th overall, as one of the
world's one hundred most sustainable companies by environmental
research and media group, Corporate Knights, and second for
biopharmaceutical companies
-
Ethics and transparency: the Hampton-Alexander independent review
body, which works to support improvements in women's representation
at board level and in leadership roles two layers below the board,
recently published its latest review. In the reviews FTSE 100
ranking, AstraZeneca moved up from seventh place in 2018 to sixth
in 2019 for women represented in the top-three layers of
management
A more extensive sustainability update is provided later in this
announcement.
Notes
These notes refer to pages one to five.
1. Tagrisso, Imfinzi, Lynparza, Calquence, Farxiga, Brilinta, Lokelma, Fasenra, Bevespi and Breztri. These new medicines are pillars in the main
therapy areas and are important platforms for future growth. Over
time, Enhertu and roxadustat will be added to this
list.
2. Constant exchange rates. These are
financial measures that are not accounted for according
to generally-accepted
accounting principles (GAAP) because they remove the effects of
currency movements from Reported results.
3. New Cardiovascular (CV), Renal
& Metabolism comprises Diabetes
medicines, Brilinta and Lokelma. Over time, roxadustat will be added to this
list.
4. Specialty-care medicines comprise
all Oncology medicines, Brilinta, Lokelma and Fasenra.
5.
Reported financial measures are the financial results presented in
accordance with International Financial Reporting Standards, as
issued by the International Accounting Standards Board and adopted
by the EU. The UK is yet to announce its IFRS endorsement process
and is anticipated to continue to follow the EU endorsement process
for the foreseeable future.
6.
Core financial measures. These are non-GAAP financial measures
because, unlike Reported performance, they cannot be derived
directly from the information in the Group's Financial Statements.
See the operating and financial review for a definition of Core
financial measures and a reconciliation of Core to Reported
financial measures.
7.
Earnings per share.
8.
FibroGen and AstraZeneca are collaborating on the development and
commercialisation of roxadustat in the US, China, and other global
markets. FibroGen and Astellas Pharma Inc. (Astellas) are
collaborating on the development and commercialisation of
roxadustat in territories including Japan, Europe, the Commonwealth
of Independent States, the Middle East, and South
Africa.
9. Merck
& Co., Inc., Kenilworth, NJ, US, known as MSD outside the US
and Canada.
10.
United Nations International Children's Emergency
Fund.
Table 4: pipeline highlights
The following table highlights significant developments in the
late-stage pipeline since the prior results
announcement:
|
Regulatory
approvals
|
- Imfinzi -
unresectable[10],
Stage III NSCLC[11] (CN)
- Lynparza -
ovarian cancer (1st line[12],
BRCAm[13])
(SOLO-1) (CN)
- Lynparza -
pancreatic cancer (1st line, BRCAm) (US)
- Enhertu -
breast cancer (3rd line, HER2+[14])
(US)
- Calquence -
CLL[15] (US)
- Qtrilmet -
T2D[16] (EU)
- Lokelma -
hyperkalaemia (CN)
- Breztri -
COPD[17] (CN)
|
|
Regulatory
submission acceptances and/or submissions
|
- Imfinzi -
SCLC[18] (ED[19]):
regulatory submission (JP), acceptance (EU), Priority Review
(US)
- Lynparza -
ovarian cancer (1st line) (PAOLA-1): regulatory submission (JP),
acceptance (EU), Priority Review (US)
- Lynparza -
prostate cancer (2nd line): regulatory submission acceptance (EU),
Priority Review (US)
- Calquence -
CLL: regulatory submission (JP), acceptance (EU)
- selumetinib -
NF1[20]:
regulatory submission acceptance, Priority Review
(US)
- Farxiga -
HF[21] CVOT[22]:
regulatory submission (JP, CN), acceptance (EU), Priority Review
(US)
- Brilinta -
CAD[23]/T2D
CVOT: regulatory submission (JP, CN)
- roxadustat -
anaemia from CKD[24]:
regulatory submission acceptance (US)8
- Symbicort -
mild asthma: regulatory submission (CN)
|
|
Major
Phase
III data readouts or other significant developments
|
- Imfinzi +/-
treme - NSCLC (1st line) (POSEIDON): met Phase III primary endpoint
(PFS[25])
- Imfinzi,
tremelimumab - HCC[26]:
Orphan Drug Designation (US)
- Enhertu -
gastric cancer (3rd line, HER2+): met Phase II primary and key
secondary (OS[27])
endpoints
- Brilinta -
stroke: met Phase III primary endpoint
- Epanova -
mixed dyslipidaemia: Phase III terminated as unlikely to meet
primary endpoint
- roxadustat
- anaemia from CKD: met Phase III pooled safety
objective
- cotadutide -
NASH[28]:
Fast Track designation (US)
|
Table 5: pipeline - anticipated major news flow
Innovation is critical to addressing unmet patient needs and is at
the heart of the Company's growth strategy. The focus on research
and development is designed to yield strong and sustainable results
from the pipeline.
|
Timing
|
News
flow
|
|
H1 2020
|
- Imfinzi -
SCLC (ED): regulatory decision (US)
- Imfinzi +/-
treme - bladder cancer (1st line) (DANUBE): data readout,
regulatory submission
- Imfinzi +/-
treme - head & neck cancer (1st line): data readout, regulatory
submission
- Lynparza -
ovarian cancer (1st line) (PAOLA-1): regulatory decision
(US)
- Lynparza -
breast cancer (BRCAm): regulatory decision (CN)
- Lynparza -
prostate cancer (2nd line): regulatory decision (US)
- Lynparza +
cediranib - ovarian cancer (2nd line): data readout
- Enhertu -
breast cancer (3rd line, HER2+): regulatory decision
(JP)
- Enhertu -
gastric cancer (3rd line, HER2+): regulatory
submission
- selumetinib
- NF1: regulatory decision (US)
- selumetinib
- NF1: regulatory submission (EU)
- Forxiga -
T2D CVOT: regulatory decision (CN)
- Farxiga -
HF CVOT: regulatory decision (US)
- Brilinta -
stroke (THALES): regulatory submission
- Lokelma -
hyperkalaemia: regulatory decision (JP)
- Symbicort -
mild asthma: regulatory submission (EU)
- Bevespi -
COPD: regulatory decision (CN)
|
|
H2 2020
|
- Imfinzi -
unresectable, Stage III NSCLC (PACIFIC-2): data
readout
- Imfinzi -
SCLC (ED): regulatory decision (EU, JP)
- Imfinzi -
SCLC (ED): regulatory submission (CN)
- Imfinzi +/-
treme - HCC (1st line): data readout
- Lynparza -
ovarian cancer (1st line) (PAOLA-1): regulatory decision
(EU)
- Lynparza -
ovarian cancer (3rd line, BRCAm): regulatory submission
(US)
- Lynparza -
pancreatic cancer (1st line, BRCAm): regulatory decision
(EU)
- Lynparza -
prostate cancer (2nd line): regulatory decision (EU)
- Enhertu -
breast cancer (3rd line, HER2+): regulatory submission
(EU)
- Calquence -
CLL: regulatory decision (EU)
- Forxiga -
HF CVOT: regulatory decision (EU, JP, CN)
- Brilinta/Brilique -
CAD/T2D CVOT: regulatory decision (US, EU)
- roxadustat
- anaemia from CKD: regulatory decision (US)
- Symbicort -
mild asthma: regulatory decision (CN)
- Fasenra -
nasal polyposis: data readout
- PT010
- COPD: regulatory decision (US, EU)
- PT027
- asthma: data readout
- tezepelumab
- severe asthma: data readout
- anifrolumab
- lupus (SLE[29]):
regulatory submission
|
|
2021
|
- Imfinzi -
adjuvant NSCLC: data readout, regulatory submission
- Imfinzi -
unresectable, Stage III NSCLC (PACIFIC-2): regulatory
submission
- Imfinzi +/-
treme - NSCLC (1st line) (POSEIDON): data readout (OS), regulatory
submission
- Imfinzi +/-
treme - SCLC (LD[30]): data
readout
- Imfinzi +/-
treme - HCC (1st line): regulatory submission
- Imfinzi -
HCC (locoregional): data readout, regulatory
submission
- Lynparza -
adjuvant breast cancer: data readout, regulatory
submission
- Lynparza -
prostate cancer (1st line, castration-resistant): data readout,
regulatory submission
- Lynparza +
cediranib - ovarian cancer (2nd line): regulatory
submission
- Enhertu -
breast cancer (3rd line, HER2+) (Phase III): data readout,
regulatory submission
- Enhertu -
breast cancer (2nd line, HER2+): data readout
- Enhertu -
breast cancer (HER2-low): data readout
- Calquence -
CLL: regulatory decision (JP)
- Farxiga -
chronic kidney disease: data readout, regulatory
submission
- roxadustat -
anaemia from myelodysplastic syndrome[31]:
data readout
- Fasenra -
nasal polyposis: regulatory submission
- PT027
- asthma: regulatory submission
- tezepelumab
- severe asthma: regulatory submission
|
Conference call
A conference call and webcast for investors and analysts will begin
at 12pm UK time today. Details can be accessed
via astrazeneca.com.
Reporting calendar
The Company intends to publish its first quarter financial results
on 29 April 2020.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: 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. 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 year to 31 December 2019 (the year or FY 2019) and
three-month period to 31 December 2019 (the quarter or Q4 2019)
compared to the year to 31 December 2018 (FY 2018) and three-month
period to 31 December 2018 (Q4 2018) 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 Condensed
Consolidated Financial Statements. Management believes that these
non-GAAP financial measures, when provided in combination with
Reported results, will provide investors and analysts with helpful
supplementary information to understand better the financial
performance and position of the Group on a comparable basis from
period to period. These non-GAAP financial measures are not a
substitute for, or superior to, financial measures prepared in
accordance with GAAP. Core financial measures are adjusted to
exclude certain significant items, such as:
-
Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT
assets
-
Charges and provisions related to restructuring programmes, which
includes charges that relate to the impact of restructuring
programmes on capitalised IT assets
-
Other specified items, principally comprising 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 76 of the Annual
Report and
Form 20-F Information 2018. Reference should be made to the
reconciliation of Core to Reported financial information and the
Reconciliation of Reported to Core financial measures table
included in the financial performance section of 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
Consolidated Financial Information section of 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 6: Total Revenue
|
|
FY 2019
|
Q4 2019
|
|
|
$m
|
% change
|
$m
|
% change
|
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Product Sales
|
23,565
|
12
|
15
|
6,250
|
8
|
9
|
|
Collaboration Revenue
|
819
|
(21)
|
(20)
|
414
|
(36)
|
(36)
|
|
|
|
|
|
|
|
|
|
Total Revenue
|
24,384
|
10
|
13
|
6,664
|
4
|
5
|
Table 7: Product Sales
|
|
FY 2019
|
Q4 2019
|
|
|
$m
|
|
% change
|
$m
|
|
% change
|
|
|
% of total
|
Actual
|
CER
|
% of total
|
Actual
|
CER
|
|
Oncology
|
8,667
|
37
|
44
|
47
|
2,274
|
36
|
29
|
29
|
|
BioPharmaceuticals
|
9,767
|
41
|
10
|
13
|
2,705
|
43
|
10
|
11
|
|
New CVRM
|
4,376
|
19
|
9
|
12
|
1,168
|
19
|
6
|
7
|
|
Respiratory
|
5,391
|
23
|
10
|
13
|
1,537
|
25
|
13
|
14
|
|
Other medicines
|
5,131
|
22
|
(16)
|
(13)
|
1,271
|
20
|
(17)
|
(16)
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
23,565
|
100
|
12
|
15
|
6,250
|
100
|
8
|
9
|
Specialty-care medicines comprise all Oncology
medicines, Brilinta, Lokelma and Fasenra. At 47% of Product Sales (FY 2018: 36%),
specialty-care medicine sales increased by 43% in the year (47% at
CER) to $10,966m.
Table 8: Top-ten medicines by Product Sales
|
Medicine
|
Therapy Area
|
FY 2019
|
Q4 2019
|
|
$m
|
% of total
|
% change
|
$m
|
% change
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Tagrisso
|
Oncology
|
3,189
|
14
|
71
|
74
|
884
|
49
|
49
|
|
Symbicort
|
Respiratory
|
2,495
|
11
|
(3)
|
-
|
712
|
12
|
13
|
|
Brilinta
|
CVRM
|
1,581
|
7
|
20
|
23
|
428
|
14
|
15
|
|
Farxiga
|
CVRM
|
1,543
|
7
|
11
|
14
|
419
|
6
|
7
|
|
Nexium
|
Other medicines
|
1,483
|
6
|
(13)
|
(11)
|
353
|
(10)
|
(10)
|
|
Imfinzi
|
Oncology
|
1,469
|
6
|
n/m
|
n/m
|
424
|
62
|
62
|
|
Pulmicort
|
Respiratory
|
1,466
|
6
|
14
|
18
|
413
|
6
|
7
|
|
Crestor
|
CVRM
|
1,278
|
5
|
(11)
|
(8)
|
296
|
(16)
|
(15)
|
|
Lynparza
|
Oncology
|
1,198
|
5
|
85
|
89
|
351
|
68
|
69
|
|
Faslodex
|
Oncology
|
892
|
4
|
(13)
|
(11)
|
166
|
(39)
|
(38)
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
16,594
|
70
|
20
|
23
|
4,446
|
15
|
16
|
Table 9: Collaboration Revenue
|
|
FY 2019
|
Q4 2019
|
|
|
$m
|
% of total
|
% change
|
$m
|
% change
|
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Initial Collaboration Revenue
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
|
|
|
Ongoing Collaboration Revenue
|
819
|
100
|
(21)
|
(20)
|
414
|
(36)
|
(36)
|
|
Royalties
|
62
|
8
|
29
|
34
|
18
|
59
|
63
|
|
Milestones/other: Lynparza
|
610
|
74
|
(23)
|
(20)
|
350
|
(44)
|
(43)
|
|
Milestones/other: nirsevimab[32]
|
34
|
4
|
n/m
|
n/m
|
-
|
n/m
|
n/m
|
|
Other Milestones/other
|
113
|
14
|
(19)
|
(18)
|
46
|
n/m
|
n/m
|
|
|
|
|
|
|
|
|
|
|
Total
|
819
|
100
|
(21)
|
(20)
|
414
|
(36)
|
(36)
|
Royalties included those associated with Nexium (over-the-counter
format), Zoladex, Tudorza/Eklira and Duaklir. Lynparza milestone and other receipts in Q4 2019, as
part of a collaboration with MSD, comprised sales-milestone income
of $250m and a final option-based receipt of
$100m.
Product Sales
The
performance of the Company's medicines is shown below, with a
geographical split shown in Notes 7 & 8.
Table 10: Therapy area and medicine performance
|
Therapy area
|
Medicine
|
FY 2019
|
Q4 2019
|
|
$m
|
% of total
|
% change
|
$m
|
% change
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Oncology
|
Tagrisso
|
3,189
|
14
|
71
|
74
|
884
|
49
|
49
|
|
Imfinzi
|
1,469
|
6
|
n/m
|
n/m
|
424
|
62
|
62
|
|
Lynparza
|
1,198
|
5
|
85
|
89
|
351
|
68
|
69
|
|
Calquence
|
164
|
1
|
n/m
|
n/m
|
56
|
n/m
|
n/m
|
|
Faslodex[33]
|
892
|
4
|
(13)
|
(11)
|
166
|
(39)
|
(38)
|
|
Zoladex33
|
813
|
3
|
8
|
13
|
196
|
8
|
9
|
|
Iressa33
|
423
|
2
|
(18)
|
(15)
|
80
|
(29)
|
(28)
|
|
Arimidex33
|
225
|
1
|
6
|
11
|
51
|
10
|
11
|
|
Casodex33
|
200
|
1
|
-
|
3
|
43
|
(6)
|
(5)
|
|
Others
|
94
|
-
|
(18)
|
(17)
|
26
|
15
|
12
|
|
Total Oncology
|
8,667
|
37
|
44
|
47
|
2,274
|
29
|
29
|
|
BioPharmaceuticals: CVRM
|
Farxiga
|
1,543
|
7
|
11
|
14
|
419
|
6
|
7
|
|
Brilinta
|
1,581
|
7
|
20
|
23
|
428
|
14
|
15
|
|
Bydureon
|
549
|
2
|
(6)
|
(5)
|
139
|
1
|
1
|
|
Onglyza
|
527
|
2
|
(3)
|
-
|
131
|
(11)
|
(10)
|
|
Byetta
|
110
|
-
|
(13)
|
(11)
|
27
|
(16)
|
(15)
|
|
Other diabetes
|
52
|
-
|
33
|
35
|
16
|
35
|
36
|
|
Lokelma
|
14
|
-
|
n/m
|
n/m
|
8
|
n/m
|
n/m
|
|
Crestor33
|
1,278
|
5
|
(11)
|
(8)
|
296
|
(16)
|
(15)
|
|
Seloken/Toprol-XL33
|
760
|
3
|
7
|
12
|
190
|
18
|
20
|
|
Atacand33
|
221
|
1
|
(15)
|
(11)
|
60
|
3
|
5
|
|
Others
|
271
|
1
|
(9)
|
(6)
|
72
|
1
|
4
|
|
BioPharmaceuticals: total CVRM
|
6,906
|
29
|
3
|
6
|
1,785
|
2
|
4
|
|
BioPharmaceuticals: Respiratory
|
Symbicort
|
2,495
|
11
|
(3)
|
-
|
712
|
12
|
13
|
|
Pulmicort
|
1,466
|
6
|
14
|
18
|
413
|
6
|
7
|
|
Fasenra
|
704
|
3
|
n/m
|
n/m
|
206
|
65
|
65
|
|
Daliresp/Daxas
|
215
|
1
|
14
|
15
|
58
|
8
|
8
|
|
Duaklir
|
77
|
-
|
(19)
|
(15)
|
22
|
(2)
|
-
|
|
Bevespi
|
42
|
-
|
26
|
26
|
12
|
12
|
12
|
|
Breztri
|
2
|
-
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
|
Others
|
390
|
2
|
(13)
|
(9)
|
114
|
(9)
|
(7)
|
|
BioPharmaceuticals: total Respiratory
|
5,391
|
23
|
10
|
13
|
1,537
|
13
|
14
|
|
Other medicines
|
Nexium
|
1,483
|
6
|
(13)
|
(11)
|
353
|
(10)
|
(10)
|
|
Synagis
|
358
|
2
|
(46)
|
(46)
|
63
|
(75)
|
(75)
|
|
Losec/Prilosec
|
263
|
1
|
(3)
|
1
|
46
|
(24)
|
(23)
|
|
Seroquel XR/IR
|
191
|
1
|
(47)
|
(46)
|
40
|
(27)
|
(27)
|
|
Others
|
306
|
1
|
(23)
|
(20)
|
151
|
12
|
14
|
|
Total other medicines
|
2,601
|
11
|
(24)
|
(21)
|
653
|
(27)
|
(27)
|
|
|
Total Product Sales
|
23,565
|
100
|
12
|
15
|
6,250
|
8
|
9
|
Product Sales summary
Oncology
Product
Sales of $8,667m in the year; an increase of 44% (47% at CER).
Oncology Product Sales represented 37% of total Product Sales, up
from 29% in 2018.
Tagrisso
Tagrisso has been approved in 80 countries, including
the US, China, in Europe and Japan for the 1st-line treatment of
patients with epidermal growth factor receptor (EGFR)-mutated
(EGFRm) NSCLC; to date, reimbursement has been granted in 18
countries, with further reimbursement decisions anticipated
throughout 2020, as well as additional regulatory decisions in new
countries. The regulatory decisions regarding the 1st-line setting
followed Tagrisso's approval and launch in 87 countries, including
the US, China, in Europe and Japan for the 2nd-line treatment of
patients with Stage IV EGFR T790M[34]-mutated
NSCLC.
Product Sales in the year of $3,189m represented growth of 71% (74%
at CER), partly driven by the aforementioned regulatory approvals
and reimbursements in the 1st-line setting; continued growth was
also delivered in the 2nd-line setting, for example, within Europe
and Emerging Markets. Sales in the US increased by 46% in the year
to $1,268m. Q4 2019 sales in the US, however, grew sequentially by
only 2% reflecting an increase in inventory movements in Q3 2019
and adverse gross-to-net adjustments[35] in
the fourth quarter. Demand continued and Tagrisso is established as the standard of
care (SoC) in the 1st-line setting, following regulatory
approval in 2018.
In
Emerging Markets, Tagrisso sales increased by 120%
in the year (130% at CER) to $762m, with notable growth in China,
following the admission to the China National Drug Reimbursement List (NRDL) in the 2nd
line setting, which took place at the start of the
year. Sales of Tagrisso in Japan increased by
100% in the year (97% at CER) to $633m; in the final quarter,
however, sales were adversely impacted by a 15% mandated price
reduction that took effect from 1 November 2019. In Europe,
sales of $474m in the year represented an increase of 51%
(59% at CER), driven by emerging use in the 1st-line setting as
more countries granted reimbursement, as well as continued strong
levels of demand in the 2nd-line setting.
Imfinzi
Imfinzi is approved in 61 countries, including the US,
China, in Europe and Japan for the treatment of patients with
unresectable, Stage III NSCLC whose disease has not progressed
following platinum-based chemoradiation therapy (CRT). It is also
approved for the 2nd-line treatment of patients with locally
advanced or metastatic urothelial carcinoma (bladder cancer) in 15
countries, including the US.
Global
Product Sales of Imfinzi increased by
132% in the
year (133% at CER) to $1,469m, of which $1,041m were in the US, almost
entirely for the treatment of unresectable, Stage III NSCLC; sales
in the US increased by 85% in the year. In Japan, sales
of $211m (FY 2018:
$35m) reflected encouraging
levels of demand, supported by higher CRT and treatment
rates. Sales in Europe of $179m (FY 2018: $27m)
followed recent regulatory approvals and launches.
Lynparza
By the end of the year, Lynparza was approved in 73 countries for the
treatment of ovarian cancer. Launches for the treatment of
metastatic breast cancer took place in the US and Japan in 2018 and
regulatory approval was granted in the EU in April
2019. Lynparza has now been approved in 58 countries for
the treatment of metastatic breast cancer and, in the US, for the
treatment of pancreatic cancer.
Product Sales of Lynparza amounted to $1,198m in the year, an increase
of 85% (89% at CER). The strong performance was geographically
spread, with launches continuing in Emerging Markets and the
Established Rest of World region (RoW). Ongoing MSD co-promotion
efforts also contributed to sales.
US sales increased by 81% to $626m, driven by the
launch in the 1st-line BRCAm ovarian cancer setting at the end of
2018. Lynparza remained the leading medicine in the US in
the PARP-inhibitor class, as measured by total prescription volumes
in both ovarian and breast cancer. Sales in Europe increased by 51%
(59% at CER) to $287m, driven by increasing levels of reimbursement
and BRCA-testing rates, as well as the recent 1st-line ovarian- and
breast-indication launches.
Japan sales of Lynparza amounted to $130m in the year, representing
growth of 170% (167% at CER). Emerging Markets sales of $133m, up
by 161% (177% at CER), reflected the regulatory approval
of Lynparza as a 2nd-line maintenance treatment of
patients with ovarian cancer by the China National Medical Products
Administration (NMPA); Lynparza was recently admitted to the China NRDL for
the same indication, with effect from January
2020.
Calquence
Product Sales in the year of $164m; an increase of 164%, with most
sales in the US. Calquence was recently approved by the US FDA for the
treatment of CLL and small lymphocytic lymphoma (SLL) in November
2019.
Legacy: Iressa
Product
Sales in the year of $423m; a decline of 18% (15% at
CER).
Emerging Markets sales were stable in the year (up
by 4% at CER) at $286m; Iressa continued to be included on the China
volume-based procurement programme. Given the growing use
of Tagrisso, sales of Iressa in the US declined by 33% to $17m and by 36%
(32% at CER) to $70m in Europe. Japan sales amounted to $44m,
reflecting a decline of 50%.
Legacy: Faslodex
Product
Sales in the year of $892m; a decline of 13% (11% at
CER).
Emerging Markets sales of Faslodex increased by 29% in the year (36%
at CER) to $198m. US sales declined by 39% to $328m,
reflecting the launch of multiple generic Faslodex medicines; in Q4
2019, Faslodex sales in the US declined by 88% to $17m. In
Europe, where generic competitor medicines are established, sales
in the year increased by 3% (9% at CER) to $229m, while in Japan,
sales increased by 20% (19% at CER) to $131m.
Legacy: Zoladex
Product
Sales in the year of $813m; an increase of 8% (13% at
CER).
Emerging Markets sales of Zoladex increased by 20% (28% at CER) in
the year to $492m. Sales in Europe increased by 2% (7% at
CER) to $135m. In the Established RoW region, sales declined by 11%
(10% at CER) to $179m, driven by the effects of increased
competition.
Further in prostate cancer, the agreement between
AstraZeneca and Janssen Pharmaceutical K. K. in Japan for the
co-promotion of abiraterone acetate, announced in
2013, recently ceased; sales of
abiraterone acetate recorded by AstraZeneca amounted to $36m in the
year.
BioPharmaceuticals: CVRM
Total CVRM sales, which include Crestor and other legacy medicines, increased by 3%
in the year (6% at CER) to $6,906m and represented 29% of total
Product Sales (FY 2018: 32%).
New CVRM sales increased by 9% in the year (12% at CER) to
$4,376m, reflecting strong performances
from Farxiga and Brilinta. New CVRM sales represented 19% of Product Sales
in the year (FY 2018: 19%).
Farxiga
Product
Sales of $1,543m in the year; an increase of 11% (14% at
CER).
Emerging Markets sales increased by 40% (48% at CER) to $471m,
reflecting growth in the sodium-glucose transport protein 2
(SGLT-2) class at the expense of the dipeptidyl-peptidase 4 class;
there was also a further improvement in levels of
access. Farxiga was admitted to the China NRDL with effect
from the start of 2020.
US sales declined by 9% to $537m, impacted by changes in formulary
access for competitor medicines at the beginning of the
year. The level of sales growth in the US in the year was also
adversely affected by the impact on price from increased levels of
competition, the mix of sales and managed markets. There were
favourable movements in the share of new-to-brand prescriptions in
the second half, however, a result of a label update in the US to
reflect results from the DECLARE CVOT. US sales increased
sequentially by 12% from Q3 2019 to Q4 2019.
Sales in Europe increased by 18% (25% at CER) to $373m, partly
reflecting growth in the SGLT-2 class and an acceleration on
new-to-brand prescriptions following the aforementioned DECLARE
label update. In Japan, sales to the collaborator, Ono
Pharmaceutical Co., Ltd, which records in-market sales, increased
by 16% (14% at CER) to $87m.
Onglyza
Product Sales of $527m in the year; a decline of 3% (stable at
CER).
Sales in Emerging Markets increased by 3% (9% at CER) to $176m,
driven by the performance in China. Growth in the US was
supported by improved pricing; US sales of Onglyza increased by 3% in the year to $230m. The US
performance in FY 2018 was adversely impacted by the effect of
gross-to-net adjustments, resulting in a favourable comparison for
FY 2019. There was also a benefit from the mix of sales and
managed markets, offsetting declining class-driven volumes. Europe
sales declined by 22% (17% at CER) to $70m, highlighting the
broader trend of a shift away from the dipeptidyl peptidase-4
inhibitor class. Given the significant future potential
of Farxiga, the Company continues to prioritise commercial
support over Onglyza.
Bydureon
Product Sales of $549m in the year; a decline of 6% (5% at
CER).
Sales were impacted by production constraints in the first half of
the year for the new Bydureon
BCise device and declining
volumes for the dual-chamber pen; these constraints were resolved
in the second half of the year. US sales of $459m represented a
decline of 3% in the year, resulting from the pricing impact of
managed markets and the transition to the BCise device. Bydureon sales in Europe fell by 19% (14% at CER) to
$66m.
Brilinta
Product Sales of $1,581m in the year; an increase of 20% (23%
at CER).
Patient uptake continued in the treatment of acute coronary
syndrome and high-risk post-myocardial
infarction. Emerging Markets sales of Brilinta increased by 42% (49% at CER) to $462m. US
sales of Brilinta, at $710m, represented an increase of 21%, driven
primarily by increasing levels of demand in both hospital and
retail settings, as well as a lengthening in the average-weighted
duration of treatment, reflecting the growing impact of 90-day
prescriptions. Sales of Brilique in Europe increased by 1% in the year (7% at
CER) to $351m, driven by performances in Spain, Italy and the
UK.
Lokelma
Product Sales of $14m in the year (FY 2018: $nil), predominantly in
the US, reflecting the recent launch of the
medicine. Lokelma represented strong levels of new-to-brand
prescriptions by market share at the end of the period in the US.
It is also approved in China and in the EU for the treatment of
hyperkalaemia; launches in several markets are expected
soon.
Legacy: Crestor
Product
Sales of $1,278m in the year; a decline of 11% (8% at
CER).
Sales in Emerging Markets declined by 4% (stable at CER) to $806m.
The performance was adversely impacted in the final quarter by the
effect of volume-based procurement in China; sales
of Crestor in Emerging Markets declined by 12% in the
quarter (10% at CER) to $185m. US sales declined by 39% to
$104m, reflecting the ongoing effect of competition from
generic Crestor medicines. In Europe, sales declined by 27%
(23% at CER) to $148m, reflecting a similar impact. In Japan, where
AstraZeneca collaborates with Shionogi Co. Ltd, sales increased by
3% (2% at CER) to $171m. This followed a period of decline
resulting from the entry of multiple
generic Crestor medicines in the Japan market at the end of
2017.
BioPharmaceuticals: Respiratory
Product Sales of $5,391m in the year; an increase of 10% (13% at
CER). Respiratory represented 23% of total Product Sales (FY 2018:
23%).
Symbicort
Product
Sales in the year of $2,495m; a decline of 3% (stable at
CER).
Symbicort continued its
global market-volume leadership within the inhaled corticosteroid
(ICS) / long-acting beta agonist (LABA) class and became
market-value leader. Emerging Markets sales increased by 11% in the
year (17% at CER) to $547m, reflecting particularly strong
performances in China, Latin America and Asia Pacific. In contrast,
however, volume growth in the US was offset by the impact of
continued pricing pressure and managed-market rebates; US sales
declined by 4% to $829m. This contrasted with US sales
of Symbicort in Q4 2019, where sales increased by 18% to
$244m, partly driven by a comparison with one-off unfavourable
adjustments in Q4 2018. Building on this performance, AstraZeneca
entered an agreement in January 2020 with Prasco, LLC to distribute
an authorised-generic version of Symbicort in the US.
In Europe, sales declined by 12% in the year (7% at CER) to $678m,
driven by price competition and government pricing interventions.
In Japan, sales increased by 9% in the year (7% at CER) to $226m,
supported by the impact of AstraZeneca regaining full rights,
following termination earlier in the year of the Astellas
co-promotion agreement.
Pulmicort
Product
Sales in the year of $1,466m; an increase of 14% (18% at
CER).
Emerging Markets, where sales increased by 20% in
the year (24% at CER) to $1,190m, represented 81% of global sales
of Pulmicort. The performance in China was strengthened by
higher levels of demand and was underpinned by the impact of
AstraZeneca's support in China for over 17,500 nebulisation
centres. Sales in the US declined by 5% to $110m and sales in
Europe declined by 10% (4% at CER) to $81m reflecting the legacy
status of the medicine.
Fasenra
Fasenra has been approved in 53 countries, including
the US, in the EU and Japan for the treatment of severe,
uncontrolled eosinophilic asthma, with further regulatory reviews
ongoing; Fasenra has achieved reimbursement in 36
countries.
Product
Sales in the year of $704m, an increase of 137% (139% at
CER).
Sales in the US increased by 121% in the year to
$482m. In patients with severe, uncontrolled
asthma, Fasenra ended the year as the leading novel biologic
medicine, as measured by new-to-brand
prescriptions.
In Europe, sales of $118m in the year represented
an increase of 268% (287% at CER). Sales in Japan increased by 91%
(89% at CER) to $86m in the year, following the medicine's launch
in 2018. In its approved indication and among new
patients, Fasenra obtained the leading market share of all
biologics in the top-five European countries and in
Japan.
Daliresp/Daxas
Product
Sales in the year of $215m; an increase of 14% (15% at
CER).
US
sales, representing 86% of the global total, increased by 19% to
$184m in the year, driven by favourable affordability-programme
changes and inventory movements.
Duaklir
Product
Sales in the year of
$77m; a decline of 19% (15% at CER).
In
2019, the overwhelming majority of sales were in Europe, where
sales declined by 22% (17% at CER) to $71m, mainly a result of an
adverse performance in Germany. As part of the collaboration agreement announced
in March 2017, Circassia Pharmaceuticals plc (Circassia) became
responsible for the commercialisation of Duaklir in the US, with AstraZeneca continuing to
manufacture and supply the medicine.
Bevespi
Product Sales in the year of $42m; an increase of 26%.
Bevespi saw prescriptions
in the period track in line with other long-acting muscarinic
antagonists / LABA launches; the class in the US, however,
continued to grow more slowly than anticipated.
Breztri
Product Sales in the year of $2m (FY 2018: $nil), entirely in
Japan.
In December 2019, Breztri received regulatory approval in China as a
triple-combination therapy for the treatment of COPD. It also
received regulatory approval in Japan earlier in the
year.
Other medicines (outside the three main therapy
areas)
Product Sales of $2,601m in the year; a decline of 24% (21% at
CER). Other Product Sales represented 11% of total Product Sales,
down from 16% in FY 2018 and 21% in FY 2017.
Nexium
Product
Sales in the year of $1,483m; a decline of 13% (11% at
CER).
Emerging Markets sales of Nexium increased by 8% (14% at CER) to $748m. In
Europe, sales declined by 73% (72% at CER) to $63m, following
divestment of prescription medicine rights in 2018. Sales in the US
declined by 29% to $218m, reflecting its 2015 loss of exclusivity
and, in Japan, where AstraZeneca collaborates with Daiichi Sankyo,
sales declined by 1% (2% at CER) to $401m.
Regional Product Sales
Table 11: Regional Product Sales
|
|
FY 2019
|
Q4 2019
|
|
$m
|
% of total
|
% change
|
$m
|
% change
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Emerging Markets
|
8,165
|
35
|
18
|
24
|
2,091
|
18
|
20
|
|
China
|
4,880
|
21
|
29
|
35
|
1,189
|
25
|
28
|
|
Ex-China
|
3,285
|
14
|
6
|
12
|
902
|
10
|
11
|
|
|
|
|
|
|
|
|
|
|
US
|
7,747
|
33
|
13
|
13
|
2,059
|
1
|
1
|
|
|
|
|
|
|
|
|
|
|
Europe
|
4,350
|
18
|
(2)
|
2
|
1,182
|
1
|
4
|
|
|
|
|
|
|
|
|
|
|
Established RoW
|
3,303
|
14
|
17
|
18
|
918
|
16
|
13
|
|
Japan
|
2,548
|
11
|
27
|
26
|
719
|
22
|
17
|
|
Canada
|
470
|
2
|
(4)
|
(1)
|
126
|
(4)
|
(3)
|
|
Other Established RoW
|
285
|
1
|
(13)
|
(4)
|
73
|
5
|
10
|
|
|
|
|
|
|
|
|
|
|
Total
|
23,565
|
100
|
12
|
15
|
6,250
|
8
|
9
|
Table 12: Emerging Markets Product Sales
|
|
FY 2019
|
Q4 2019
|
|
$m
|
% of total
|
% change
|
$m
|
% change
|
|
Actual
|
CER
|
Actual
|
CER
|
|
Oncology
|
2,211
|
27
|
45
|
52
|
546
|
54
|
57
|
|
BioPharmaceuticals
|
3,120
|
38
|
25
|
31
|
865
|
18
|
20
|
|
New CVRM
|
1,133
|
14
|
33
|
41
|
297
|
25
|
27
|
|
Respiratory
|
1,987
|
24
|
21
|
27
|
568
|
14
|
16
|
|
Other medicines
|
2,834
|
35
|
(1)
|
4
|
680
|
1
|
2
|
|
|
|
|
|
|
|
|
|
|
Total
|
8,165
|
100
|
18
|
24
|
2,091
|
18
|
20
|
Table 13: Notable new-medicine performances in Emerging
Markets
|
Product Sales
|
FY 2019
$m
|
% change
|
|
Actual
|
CER
|
|
Tagrisso
|
762
|
n/m
|
n/m
|
|
Lynparza
|
133
|
n/m
|
n/m
|
|
Farxiga
|
471
|
40
|
48
|
|
Brilinta
|
462
|
42
|
49
|
New medicines represented 23% of Emerging Markets sales (FY 2018:
15%). Sales of specialty-care medicines increased by 44% (52% at
CER) to $2,678m and comprised 33% of Emerging Markets sales in the
year (FY 2018: 27%).
Table 14: Notable other performances in Emerging
Markets
|
Product Sales
|
FY 2019
$m
|
% change
|
|
Actual
|
CER
|
|
Zoladex
|
492
|
20
|
28
|
|
Pulmicort
|
1,190
|
20
|
24
|
|
Symbicort
|
547
|
11
|
17
|
China sales comprised 60% of Emerging Markets sales in the year,
increasing by 29% (35% at CER) to $4,880m. China sales in the
quarter increased by 25% (28% at CER) to $1,189m, when the
performance was adversely impacted by the effect of volume-based
procurement in China. New-medicine sales, primarily driven
by Tagrisso and Lynparza in Oncology and Brilinta and Farxiga in New CVRM, delivered particularly
encouraging growth and represented 19% of China sales (FY 2018:
11%). This performance was augmented by strong sales
of Zoladex, Pulmicort, Nexium and Symbicort.
In early 2019, Tagrisso benefitted
from being added to the 2018 NRDL by the China National Healthcare
Security Administration (NHSA) as a treatment for patients with
Stage IV EGFR T790M-mutated NSCLC. Furthermore, the NHSA published
the preliminary 2019 NRDL in the second half of 2019, which
included one additional AstraZeneca medicine,
namely Kombiglyze for
Diabetes. Respiratory medicines Symbicort for
asthma and COPD and Nexium for
acid reflux also benefitted as reimbursement restrictions were
removed. In December 2019, the NHSA published the final 2019 NRDL,
which was updated to include a further three AstraZeneca
medicines: Lynparza in
ovarian cancer, Forxiga in
T2D and roxadustat in anaemia from CKD; Faslodex,
however, was removed from the list. Since 2012, 15 of the Company's
medicines have also been admitted to China's Essential Drugs
List[36].
Ex-China Emerging Markets sales increased by 6% in the year (12% at
CER) to $3,284m. New medicines represented 29% of Product Sales in
the year (FY 2018: 21%), increasing by 45% (53% at CER). The
performance was underpinned by strong levels of growth at CER in
the following regions:
Table 15: Ex-China Emerging Markets
|
Product Sales
|
FY 2019
|
|
% change
|
|
Actual
|
CER
|
|
Russia
|
35
|
40
|
|
Brazil
|
(2)
|
7
|
|
Ex-Brazil
Latin America
|
3
|
16
|
|
Ex-China
Asia Pacific
|
8
|
10
|
|
Middle
East and Africa
|
3
|
8
|
Financial performance
Table 16: Reported Profit and Loss
|
|
FY 2019
|
FY 2018
|
% change
|
Q4 2019
|
Q4 2018
|
% change
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
|
Product Sales
|
23,565
|
21,049
|
12
|
15
|
6,250
|
5,768
|
8
|
9
|
|
Collaboration Revenue
|
819
|
1,041
|
(21)
|
(20)
|
414
|
649
|
(36)
|
(36)
|
|
Total Revenue
|
24,384
|
22,090
|
10
|
13
|
6,664
|
6,417
|
4
|
5
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales
|
(4,921)
|
(4,936)
|
-
|
5
|
(1,378)
|
(1,637)
|
(16)
|
(10)
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
19,463
|
17,154
|
13
|
16
|
5,286
|
4,780
|
11
|
10
|
|
Gross Profit
Margin[37]
|
79.1%
|
76.6%
|
3
|
2
|
78.0%
|
71.6%
|
6
|
5
|
|
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(339)
|
(331)
|
2
|
7
|
(92)
|
(93)
|
(2)
|
-
|
|
% Total Revenue
|
1.4%
|
1.5%
|
-
|
-
|
1.4%
|
1.5%
|
-
|
-
|
|
R&D Expense
|
(6,059)
|
(5,932)
|
2
|
5
|
(2,091)
|
(2,012)
|
4
|
5
|
|
% Total Revenue
|
24.8%
|
26.9%
|
2
|
2
|
31.4%
|
31.4%
|
-
|
-
|
|
SG&A Expense
|
(11,682)
|
(10,031)
|
16
|
20
|
(3,026)
|
(2,600)
|
16
|
18
|
|
% Total Revenue
|
47.9%
|
45.4%
|
(2)
|
(3)
|
45.4%
|
40.5%
|
(5)
|
(5)
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses
|
(18,080)
|
(16,294)
|
11
|
14
|
(5,209)
|
(4,705)
|
11
|
12
|
|
% Total Revenue
|
74.1%
|
73.8%
|
-
|
-
|
78.2%
|
73.3%
|
(5)
|
(5)
|
|
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
1,541
|
2,527
|
(39)
|
(38)
|
500
|
1,002
|
(50)
|
(50)
|
|
% Total Revenue
|
6.3%
|
11.4%
|
(5)
|
(5)
|
7.5%
|
15.6%
|
(8)
|
(8)
|
|
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
2,924
|
3,387
|
(14)
|
(16)
|
577
|
1,077
|
(46)
|
(56)
|
|
Operating Profit Margin
|
12.0%
|
15.3%
|
(3)
|
(4)
|
8.7%
|
16.8%
|
(8)
|
(10)
|
|
Net Finance Expense
|
(1,260)
|
(1,281)
|
(2)
|
4
|
(312)
|
(311)
|
-
|
(1)
|
|
Joint Ventures and Associates
|
(116)
|
(113)
|
3
|
5
|
(25)
|
(36)
|
(30)
|
(30)
|
|
Profit Before Tax
|
1,548
|
1,993
|
(22)
|
(29)
|
240
|
730
|
(67)
|
(79)
|
|
Taxation
|
(321)
|
57
|
n/m
|
n/m
|
37
|
279
|
(87)
|
(81)
|
|
Tax Rate
|
21%
|
-3%
|
|
|
-15%
|
-38%
|
|
|
|
Profit After Tax
|
1,227
|
2,050
|
(40)
|
(45)
|
277
|
1,009
|
(72)
|
(80)
|
|
|
|
|
|
|
|
|
|
|
|
EPS
|
1.03
|
1.70
|
(40)
|
(44)
|
0.24
|
0.82
|
(71)
|
(78)
|
Table 17:
Reconciliation of Reported Profit Before Tax to
EBITDA[38]
|
|
FY 2019
|
FY 2018
|
% change
|
Q4 2019
|
Q4 2018
|
% change
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
|
Reported Profit Before Tax
|
1,548
|
1,993
|
(22)
|
(29)
|
240
|
730
|
(67)
|
(79)
|
|
Net Finance Expense
|
1,260
|
1,281
|
(2)
|
4
|
312
|
311
|
-
|
(1)
|
|
Joint Ventures and Associates
|
116
|
113
|
3
|
5
|
25
|
36
|
(30)
|
(30)
|
|
Depreciation, Amortisation and Impairment
|
3,762
|
3,753
|
-
|
3
|
1,643
|
1,662
|
(1)
|
-
|
|
|
|
|
|
|
|
|
|
|
|
EBITDA
|
6,686
|
7,140
|
(6)
|
(6)
|
2,220
|
2,739
|
(19)
|
(22)
|
Table 18: FY 2019 reconciliation of Reported to Core financial
measures
|
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Diabetes Alliance
|
Other[39]
|
Core[40]
|
Core % change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
|
Gross Profit
|
19,463
|
73
|
87
|
-
|
-
|
19,623
|
10
|
13
|
|
Gross Profit Margin
|
79.1%
|
|
|
|
|
79.8%
|
-
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(339)
|
-
|
-
|
-
|
-
|
(339)
|
2
|
7
|
|
R&D Expense
|
(6,059)
|
101
|
638
|
-
|
-
|
(5,320)
|
1
|
4
|
|
SG&A Expense
|
(11,682)
|
173
|
1,771
|
(126)
|
775
|
(9,089)
|
5
|
8
|
|
Total Operating Expenses
|
(18,080)
|
274
|
2,409
|
(126)
|
775
|
(14,748)
|
4
|
7
|
|
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
1,541
|
-
|
1
|
-
|
19
|
1,561
|
(27)
|
(26)
|
|
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
2,924
|
347
|
2,497
|
(126)
|
794
|
6,436
|
13
|
13
|
|
Operating Profit Margin
|
12.0%
|
|
|
|
|
26.4%
|
+1
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Net Finance Expense
|
(1,260)
|
-
|
-
|
287
|
208
|
(765)
|
4
|
10
|
|
Taxation
|
(321)
|
(66)
|
(519)
|
(54)
|
(149)
|
(1,109)
|
n/m
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
EPS
|
$1.03
|
$0.22
|
$1.52
|
$0.08
|
$0.65
|
$3.50
|
1
|
-
|
Table 19: Q4 2019 reconciliation of Reported to Core financial
measures
|
|
Reported
|
Restructuring
|
Intangible Asset
Amortisation & Impairments
|
Diabetes Alliance
|
Other41
|
Core42
|
Core
% change
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
|
Gross Profit
|
5,286
|
(49)
|
18
|
-
|
-
|
5,255
|
1
|
1
|
|
Gross Profit Margin
|
78.0%
|
|
|
|
|
77.5%
|
-1
|
-2
|
|
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(92)
|
-
|
-
|
-
|
-
|
(92)
|
(2)
|
-
|
|
R&D Expense
|
(2,091)
|
19
|
578
|
-
|
-
|
(1,494)
|
2
|
4
|
|
SG&A Expense
|
(3,026)
|
26
|
762
|
(420)
|
33
|
(2,625)
|
8
|
9
|
|
Total Operating Expenses
|
(5,209)
|
45
|
1,340
|
(420)
|
33
|
(4,211)
|
5
|
7
|
|
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
500
|
-
|
(2)
|
-
|
3
|
501
|
(50)
|
(50)
|
|
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
577
|
(4)
|
1,356
|
(420)
|
36
|
1,545
|
(29)
|
(33)
|
|
Operating Profit Margin
|
8.7%
|
|
|
|
|
23.2%
|
-11
|
-12
|
|
|
|
|
|
|
|
|
|
|
|
Net Finance Expense
|
(312)
|
-
|
-
|
71
|
55
|
(186)
|
6
|
-
|
|
Taxation
|
37
|
8
|
(279)
|
52
|
(13)
|
(195)
|
n/m
|
n/m
|
|
EPS
|
$0.24
|
-
|
$0.83
|
($0.23)
|
$0.05
|
$0.89
|
(44)
|
(46)
|
Profit and Loss summary
a) Gross Profit
The increase in Reported and Core Gross Profit for the year was a
reflection of the growth in Product Sales. Reported Gross Profit
was adversely impacted in the prior year by the recognition of
costs associated with the closure of two biologic-medicine
manufacturing sites in Colorado, US. A partial reversal of these
costs was recorded in the quarter.
Following the recommendation from an independent Data Monitoring
Committee, AstraZeneca recently decided to terminate the Phase III
STRENGTH trial for Epanova (omega-3 carboxylic acids), due to its low
likelihood of demonstrating a benefit to patients with mixed
dyslipidaemia who are at increased risk of CV disease. This was
considered to be an adjusting event after the reporting period,
resulting in a provision for inventory and supply-related costs of
$115m, recorded in Reported and Core Cost of Sales in FY
2019.
b) Operating Expense
Reported
Operating Expense in the year represented 74% of Total Revenue (FY
2018: 74%), Core Operating Expense represented 60% of Total Revenue
(FY 2018: 64%).
Reported and Core R&D Expense increased partly
a result of investment in the development
of Enhertu. Reported and Core SG&A Expense grew
primarily because of investment in additional colleagues to support
the China expansion strategy, as well as further support for new
medicines. The difference between the growth of Reported and Core
SG&A Expense partly reflected fair-value adjustments arising on
acquisition-related liabilities recognised in 2019, as well as an
increase in legal provisions and intangible asset impairments; the
latter included impairments of Bydureon, Qtern and Tudorza/Eklira.
The aforementioned STRENGTH-trial termination also
resulted in a full impairment of the Epanova intangible asset of $533m, recorded in
Reported R&D Expense in FY 2019.
c) Other Operating Income
and Expense[41]
Reported and Core Other Operating Income and Expense in the year
included:
- $515m,
reflecting an agreement to
sell US rights to Synagis to Swedish
Orphan Biovitrum AB (publ) (Sobi)
- $243m,
reflecting an agreement to
divest the global commercial rights, excluding China, Japan, the US
and Mexico, for Losec and
associated brands to Cheplapharm Arzneimittel GmbH
(Cheplapharm)
- $213m,
reflecting agreements to
sell its commercial rights to Seroquel and Seroquel
XR in the
US, Canada, Europe and Russia to Cheplapharm
- $181m,
reflecting an agreement to
sell the commercial rights to Arimidex and Casodex in
a number of European, African and other countries to Juvisé
Pharmaceuticals
In January 2020, the Company announced that it
had agreed to divest the global commercial rights to a number of
established hypertension medicines,
including Inderal, Tenormin and Zestril to
Atnahs Pharma. Atnahs Pharma will make an upfront payment of $350m
to AstraZeneca. AstraZeneca may also receive future
sales-contingent payments of up to $40m between 2020 and 2022.
Income arising from the upfront and future payments will be
reported in AstraZeneca's financial statements within Other
Operating Income and Expense. The divestment is expected to
complete in the first quarter of 2020.
d) Net Finance Expense
Reported
and Core Net Finance Expense increased at CER in the year, partly
reflecting an adverse movement in loan interest, as well as the
effect of the adoption of IFRS 16 (see Note 1). There was also a
discount unwind in respect of the profit-participation financial
liability in relation to the aforementioned FY 2019 divestment of
the US rights to participate in the future cash flows from the US
profits or losses for nirsevimab, impacting Reported and Core
Finance Expense.
e) Taxation
The
Reported Tax Rate for the year was 21% and the Core Tax Rate was
20% (FY 2018: (3)% and 11% respectively). These tax rates were
higher than the UK Corporation Tax Rate due to the impact of the
geographical mix of profits.
f) EPS
Reported EPS of $1.03 in the year, based on a weighted-average
number of shares of 1,301m, represented a decline of 40% (44% at
CER); Core EPS increased by 1% (stable at CER) to $3.50. The
difference between the Reported and Core performance partly
reflected the impact of a favourable $346m legal settlement in FY
2018 that was recognised as income in Reported Other Operating
Income and Expense. It was also a result of an increase in legal
provisions and revaluation movements on acquisition-related
liabilities in 2019, as well as an increase in intangible asset
impairments.
In April 2019, the Company completed an issue of 44,386,214 new
ordinary shares of $0.25 each at a price of £60.50 per share,
resulting in an increase in share capital of $11m and an increase
in share premium of $3.5bn, net of transaction costs of
$22m.
g) Dividend per share
The Board reaffirms its commitment to the progressive dividend
policy; a second interim dividend of $1.90 per share (146.4 pence,
18.32 SEK) has been declared, taking the unchanged full-year
dividend per share to $2.80 (218.3 pence, 26.81 SEK). Dividend
payments are normally paid as follows:
-
First interim dividend - announced with half-year and
second-quarter results and paid in September
-
Second interim dividend - announced with full-year and
fourth-quarter results and paid in March
The record date for the second interim dividend for 2019, payable
on 30 March 2020, will be 28 February 2020. The ex-dividend date
will be 27 February 2020. The record date for the first interim
dividend for 2020, payable on 14 September 2020, will be 14 August
2020. The ex-dividend date will be 13 August 2020.
Table 20: Cash Flow
|
|
FY 2019
|
FY 2018
|
Change
|
|
|
$m
|
$m
|
$m
|
|
Reported Operating Profit
|
2,924
|
3,387
|
(463)
|
|
Depreciation, Amortisation and Impairment
|
3,762
|
3,753
|
9
|
|
|
|
|
|
|
Increase in Working Capital and Short-Term Provisions
|
(346)
|
(639)
|
293
|
|
Gains on Disposal of Intangible Assets
|
(1,243)
|
(1,885)
|
642
|
|
Non-Cash and Other Movements
|
(236)
|
(785)
|
549
|
|
Interest Paid
|
(774)
|
(676)
|
(98)
|
|
Taxation Paid
|
(1,118)
|
(537)
|
(581)
|
|
|
|
|
|
|
Net Cash Inflow from Operating Activities
|
2,969
|
2,618
|
351
|
|
|
|
|
|
|
Net Cash Inflow before Financing Activities
|
2,312
|
3,581
|
(1,269)
|
|
Net Cash Outflow from Financing Activities
|
(1,765)
|
(2,044)
|
279
|
The increase in Net Cash Inflows from Operating Activities in the
year primarily reflected an underlying improvement in business
performance, combined with favourable working-capital movements and
the impact of the adoption of IFRS 16 (Leases) on 1 January
2019. The positive cash performance was partly offset by an
increase in Taxation Paid, which represented 72% of Reported Profit
Before Tax (FY 2018: 27%); the increase in the amount paid
primarily reflected the phasing of tax payments between periods and
the impact of refunds in FY 2018, following agreement of
prior-period liabilities. The adoption of IFRS 16 resulted in a
presentational change within the cash-flow statement, whereby cash
outflows of $186m are now presented as financing, instead of
operating.
The decline in Net Cash Inflows before Financing Activities
primarily reflected the Purchase of Intangible Assets, which
included:
- The
first of two $675m upfront payments to Daiichi Sankyo as part of
the agreement on Enhertu
- The impact of a
final true-up net payment of $413m to MSD, based on sales
of Nexium and Prilosec from 2014 to 2018; this was accrued
over the same period
Payments from Pfizer, Inc. totalling $250m were received in the
year, recorded within Disposal of Intangible Assets, as part of a
prior agreement to
sell the commercialisation and development rights to AstraZeneca's
late-stage small-molecule antibiotics business in most markets
globally outside the US.
Reflecting an agreement with Luye Pharma Group Ltd, relating to the
rights to Seroquel and Seroquel
XR in the
UK, China and other international markets, announced in
June 2018, AstraZeneca received a deferred consideration payment of
$240m in the quarter, also recorded within Disposal of Intangible
Assets. Other business-development transactions are referred to in
the section Other Operating Income and Expense
above.
The cash payment of contingent consideration, in respect of the
former Bristol-Myers Squibb Company share of the global diabetes
alliance, amounted to $454m in the year (FY 2018:
$349m).
As part of the total consideration received in respect of the
aforementioned agreement to sell US rights
to Synagis, $821m was received and included in Disposal of
Intangible Assets and $150m was related to the rights to
participate in the future cash flows from the US profits or losses
for nirsevimab. This was recognised as a financial liability as the
Company did not fully transfer the risks and rewards of the
underlying cash flows arising from nirsevimab to Sobi; this was
recorded in Other Payables, within Non-current Liabilities. The
associated cash flow was presented within Investing Activities as
AstraZeneca received the payment in exchange for agreeing to
transfer future cashflows relating to an intangible
asset.
In October 2019, Circassia announced the launch
of Duaklir in
the US, upon which the Company made a $91m milestone payment to
Almirall, S.A. (Almirall). Following
the announcement in
December 2019 that Enhertu had
been approved in the US for patients with unresectable or
metastatic HER2-positive breast cancer who have received two or
more prior anti-HER2 based regimens in the metastatic setting,
AstraZeneca accrued a first milestone payment to Daiichi Sankyo for
$125m; this amount was capitalised upon
approval.
In April 2019, the Company completed a placing of new Ordinary
Shares of $3.5bn, in conjunction with the recent strategic
collaboration with Daiichi Sankyo. The purpose of the placing was
to fund the initial upfront and near-term milestone commitments
arising from the collaboration, as well as to strengthen
AstraZeneca's balance sheet. The proceeds from the placing were
recorded in the second quarter, supporting a reduced level of Net
Debt.
h) Capital expenditure
Capital expenditure amounted to $979m in the year, compared to
$1,043m in FY 2018. This included investment in the new AstraZeneca
R&D centre on the Biomedical Campus in Cambridge, UK. The
Company continues to expect total associated capital expenditure
for the project of c.$1.3bn (c.£1bn, translated at
average exchange rates for the year).
The Company anticipates a broadly stable level of total capital
expenditure in FY 2020 (FY 2019: $979m).
Table 21: Debt and capital structure
|
|
At
31 Dec 2019
|
At
31 Dec 2018
|
|
|
$m
|
$m
|
|
Cash and Cash Equivalents
|
5,369
|
4,831
|
|
Other Investments
|
911
|
895
|
|
|
|
|
|
Cash and Investments
|
6,280
|
5,726
|
|
|
|
|
|
Overdrafts and Short-Term Borrowings
|
(225)
|
(755)
|
|
Lease Liabilities[42]
|
(675)
|
-
|
|
Current Instalments of Loans
|
(1,597)
|
(999)
|
|
Loans Due After One Year
|
(15,730)
|
(17,359)
|
|
|
|
|
|
Interest-Bearing Loans and Borrowings (Gross Debt)
|
(18,227)
|
(19,113)
|
|
|
|
|
|
Net Derivatives
|
43
|
384
|
|
Net Debt
|
(11,904)
|
(13,003)
|
Capital allocation
The Board's aim is to continue to strike a balance between the
interests of the business, financial creditors and the Company's
shareholders. After providing for investment in the business,
supporting the progressive dividend policy and maintaining a
strong, investment-grade credit rating, the Board will keep under
review potential investment in immediately earnings-accretive,
value-enhancing opportunities.
Foreign exchange
The
Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies' reporting currency. In addition, the
Company's external dividend payments, paid principally in pounds
sterling and Swedish krona, are fully hedged from announcement to
payment date. Foreign-exchange gains and losses on forward
contracts for transactional hedging are taken to profit or
loss.
Table 22: Currency sensitivities
The Company provides the following currency-sensitivity
information:
|
|
Average Exchange
Rates versus USD
|
|
Annual Impact of 5% Strengthening in Exchange Rate versus USD
($m)[43]
|
|
Currency
|
Primary Relevance
|
FY 2019[44]
|
YTD 2020[45]
|
% change
|
Product Sales
|
Core Operating Profit
|
|
CNY
|
Product
Sales
|
6.92
|
6.93
|
-
|
288
|
190
|
|
EUR
|
Product
Sales
|
0.89
|
0.90
|
(1)
|
171
|
68
|
|
JPY
|
Product
Sales
|
108.98
|
109.38
|
-
|
139
|
98
|
|
Other[46]
|
|
|
|
|
231
|
123
|
|
|
|
|
|
|
|
|
|
GBP
|
Operating
Expense
|
0.78
|
0.77
|
2
|
27
|
(93)
|
|
SEK
|
Operating
Expense
|
9.46
|
9.47
|
-
|
5
|
(51)
|
Sustainability
AstraZeneca's sustainability ambition has three priority
areas[47],
aligned with the Company's purpose and business
strategy:
- Access to healthcare
- Environmental protection
- Ethics and transparency
Recent developments and progress against the Company's priorities
are reported below:
a) Access to healthcare
By the end of December 2019, AstraZeneca's Healthy Heart Africa
(HHA) programme, working with collaborators across Kenya, Ethiopia,
Tanzania and Ghana, had conducted over 13.5 million blood-pressure
screenings and identified over 2.4 million elevated readings since
its launch in 2015. In November 2019, the Company extended the
programme and launched Healthy Heart Asia in India. The launch was
conducted in collaboration with the Ganga Godavari Cancer Screening
Programme, AstraZeneca India's sustainability partner.
In January 2020, AstraZeneca announced that the YHP would partner
with UNICEF to prevent non-communicable diseases among young
people. The Company will support UNICEF with a $12.5m grant to
support programming which will reach more than five million
young people, train approximately 1,000 youth advocates,
and potentially help to shape public policy around the
world over the next six years. In October 2019, AstraZeneca
announced plans to extend the funding for the YHP for a
further five years, with a pledge of $35m to help to educate young
people on the steps that they can take to reduce the risk of
non-communicable diseases.
b) Environmental protection
In January 2020, during the World Economic Forum Annual Meeting in
Davos, Switzerland, AstraZeneca announced an ambitious programme
for zero-carbon emissions from its global operations by 2025. The
Company also announced its commitment to ensuring that its entire
value chain is carbon-negative by 2030, bringing forward
decarbonisation plans by more than a decade. The 'Ambition Zero
Carbon' strategy will accelerate the Company's existing
science-based targets, doubling energy productivity and using
renewable energy for both power and heat, as well as switching to
100% electric-vehicle fleet five years ahead of
schedule.
In addition, the Company also announced plans to invest up to $1bn
to help achieve these goals and to develop the next-generation
respiratory inhalers with near-zero Global Warming Potential
propellants. Also included in the plan is 'AZ Forest', a 50-million
tree-reforestation initiative that will be rolled out over the next
five years.
The Company was recently commended by the global environmental
impact non-profit organisation, CDP, achieving a place on both the
'A List' for Climate Change and the 'A List' for Water Security,
based on data submitted by the Company in 2019. A double 'A List'
status was achieved for the fourth consecutive year. AstraZeneca is
one of a small number of high-performing companies out of thousands
that were scored, and fewer than ten companies worldwide appeared
on both 'A Lists' in the last four years.
c) Ethics and transparency
During the period, the Workforce Disclosure
Initiative[48] released
its 2019 scorecard, underpinned by 138 institutional-investor
signatories. The Company participated for the second year,
indicating its willingness to work towards increasing the amount of
workforce data disclosed.
In January 2020, the Company was included, for the second
consecutive year, in the Bloomberg 2020 Gender-Equality Index. This
year, the index recognised 325 companies which work to advance
women in the workplace through measurement and
transparency.
During the period, the Hampton-Alexander independent review body,
which works to increase the number of women on FTSE 350 boards on a
voluntary business-led basis, published its latest review. It has a
dual focus on improving women's representation at board level and
in leadership roles two layers below board level and covers 23,000
leadership roles across all sectors of British
business.
In the FTSE 100 ranking, AstraZeneca moved up from seventh place in
2018 to sixth in 2019 for women represented in the top three layers
of leadership. With women representing 40% of leaders at this
level, the Company was the highest-ranked pharmaceutical company.
Having moved from five to four women Board members since 2018,
however, AstraZeneca dropped from 12th place to 39th place in 2019,
as this particular metric is sensitive to individual
appointments.
d) Other developments
During the period, AstraZeneca was ranked 56th overall by Corporate
Knights[49],
out of more than 7,000 companies, as one of the world's
one hundred most sustainable companies, and second among
biopharmaceutical companies.
For more details on AstraZeneca's sustainability ambition, approach
and targets, please refer to the latest Sustainability Report
2018 and Sustainability Data
Summary 2018, available
at astrazeneca.com/sustainability.
The 2019 Sustainability Report will be availability in due
course.
Research and development
A comprehensive data pack comprising AstraZeneca's
pipeline of medicines in human trials can be found in the
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 23: Update from the late-stage pipeline
|
New
molecular
entities
and major lifecycle events for medicines in Phase III trials or
under regulatory review
|
17
|
Oncology
- Tagrisso -
NSCLC
- Imfinzi -
multiple cancers
- Lynparza -
multiple cancers
- Enhertu -
breast and other cancers
- capivasertib
- breast cancer
- Calquence -
blood cancers
- tremelimumab
- multiple cancers
- selumetinib -
NF1[50]
- savolitinib
- NSCLC53
CV,
Renal & Metabolism
- roxadustat
- anaemia from CKD
Respiratory
(and immunology)
- Fasenra
- multiple indications
- Breztri -
COPD
- PT027
- asthma
- tezepelumab
- severe asthma
- nirsevimab
- lower respiratory tract infection
- anifrolumab
- lupus
-
brazikumab[51] -
inflammatory bowel disease
|
|
Total
projects
in
clinical pipeline
|
144
|
|
Oncology
At the 2019 American Society of Hematology (ASH) Annual Meeting and
Exposition in Orlando, US, the Company presented over 30 abstracts
including seven oral presentations. Highlights included the first
presentation of data from the pivotal Phase III ELEVATE TN trial,
evaluating the long-term efficacy and safety
of Calquence in combination with obinutuzumab
and Calquence monotherapy versus obinutuzumab combined
with chlorambucil chemotherapy in previously untreated
CLL.
At the 2019 San Antonio Breast Cancer Symposium (SABCS), US,
AstraZeneca presented over 30 abstracts, including three oral
presentations and two spotlight poster discussions. Highlights
included the Enhertu DESTINY-Breast01 Phase II trial data in
HER2-positive breast cancer.
Oncology: lung cancer
a) Tagrisso
Table 24: Key Tagrisso trials in lung cancer
|
Trial
|
Population
|
Design
|
Timeline
|
Status
|
|
Phase
III
ADAURA
|
Adjuvant
EGFRm NSCLC
|
Placebo
or Tagrisso
|
FPCD[52]
Q4
2015
LPCD[53]
Q1
2019
First
data anticipated
2021+[54]
|
Recruitment
completed
|
|
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
|
b) Imfinzi
In December 2019, AstraZeneca announced that it
has received marketing authorisation from the China NMPA
for Imfinzi for the treatment of patients with
unresectable, Stage III NSCLC whose disease has not progressed
following concurrent CRT. The approval of Imfinzi was based on results from the primary
analysis of PFS, supported by OS data from the Phase III PACIFIC
trial.
In November 2019, the Company announced that the
US Food and Drug Administration (FDA) had accepted a supplemental
Biologics License Application and awarded Priority Review status
for Imfinzi for the treatment of patients with
previously untreated ED SCLC, based on results from the Phase III
CASPIAN trial. A Prescription Drug User Fee Act (PDUFA)
date is set for the first quarter of 2020. The Company also
recently made regulatory submissions for Imfinzi in Japan and received a regulatory
submission acceptance in the EU for previously untreated ED SCLC.
The submissions were based on the flat dose of 1,500mg
of Imfinzi, with four cycles of chemotherapy once every
three weeks.
During the period, Imfinzi was assigned Category 1 status for the
treatment of ED SCLC patients within the US National Comprehensive
Cancer Network guidelines.
During the period, the Company announced positive PFS results
for Imfinzi and tremelimumab, an anti-CTLA4 antibody,
when added to chemotherapy, from the Phase III POSEIDON trial in
previously-untreated Stage IV (metastatic) NSCLC. The trial met a
primary endpoint by showing a statistically significant and
clinically meaningful improvement in the final PFS analysis
for Imfinzi and chemotherapy, and a key secondary
endpoint for PFS of Imfinzi plus tremelimumab and chemotherapy. The
safety and tolerability of Imfinzi was consistent with its known safety
profile; the triple combination of Imfinzi plus tremelimumab and chemotherapy delivered
a broadly similar safety profile. The trial will continue to assess
the additional primary endpoint of OS, with data anticipated in
2021.
Table 25: 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
H2
2020
|
Recruitment
ongoing
|
|
Phase
III
ADJUVANT BR.31[55]
|
Stage
Ib-IIIa NSCLC
|
Placebo
or
Imfinzi
|
FPCD
Q1
2015
LPCD
Q4
2019
First
data anticipated
2021
|
Recruitment
completed
|
|
Phase
III
PACIFIC-2
|
Stage
III unresected locally advanced NSCLC
(concurrent
CRT)
|
Placebo
or
Imfinzi
|
FPCD
Q2
2018
LPCD
Q3
2019
First
data anticipated
H2
2020
|
Recruitment
completed
|
|
Phase
III
ADRIATIC
|
Limited-disease
stage SCLC
|
Concurrent
CRT,
followed
by
placebo
or
Imfinzi or Imfinzi + treme
|
FPCD
Q4
2018
First
data anticipated
2021
|
Recruitment
ongoing
|
|
Phase
III
POSEIDON
|
Stage
IV, 1st-line NSCLC
|
SoC
chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
|
FPCD
Q2
2017
LPCD
Q4
2018
|
PFS
primary endpoint met
|
|
Phase
III
CASPIAN
|
Extensive-disease
stage SCLC
|
SoC
chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
|
FPCD
Q1
2017
LPCD
Q2
2018
|
OS
primary endpoint met for Imfinzi monotherapy
arm
|
Imfinzi as a potential new medicine in other tumour
types
The Company continues to advance multiple monotherapy trials
of Imfinzi and combination trials
of Imfinzi with tremelimumab and other potential new
medicines in tumour types other than lung
cancer.
During the period, the Company announced
that Imfinzi and tremelimumab had both been granted
Orphan Drug Designation in the US for the treatment of
HCC. Imfinzi has
now received regulatory approval for the 2nd-line treatment of
patients with locally advanced or metastatic urothelial carcinoma
(bladder cancer) in 15 countries.
Table 26: Key Imfinzi trials in tumour types other than lung
cancer
|
Trial
|
Population
|
Design
|
Timeline
|
Status
|
|
Phase
III
POTOMAC
|
Non-muscle
invasive bladder cancer
|
SoC BCG[56] or
SoC BCG + Imfinzi
|
FPCD
Q4
2018
First
data
anticipated
2021+
|
Recruitment
ongoing
|
|
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
2021+
|
Recruitment
ongoing
|
|
Phase
III
EMERALD-1
|
Locoregional
HCC
|
TACE[57] followed
by placebo or TACE + Imfinzi, followed by Imfinzi +
bevacizumab
or
TACE
+ Imfinzi
followed
by Imfinzi
|
FPCD
Q1
2019
First
data
anticipated
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
First
data anticipated
2021+
|
Recruitment
ongoing
|
|
Phase
III
DANUBE
|
Stage
IV, 1st-line cisplatin chemotherapy- eligible/ineligible bladder
cancer
|
SoC
chemotherapy or Imfinzi or Imfinzi + treme
|
FPCD
Q4
2015
LPCD
Q1
2017
First
data
anticipated
H1
2020
|
Recruitment
completed
|
|
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 head and neck squamous cell carcinoma
|
SoC
or Imfinzi or Imfinzi + treme
|
FPCD
Q4
2015
LPCD
Q1
2017
First
data
anticipated
H1
2020
|
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
2020
|
Recruitment
Completed
Orphan
Drug Designation (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
2021+
|
Recruitment
ongoing
|
Oncology: Lynparza (multiple cancers)
In December 2019, AstraZeneca announced that it had received
marketing authorisation from the China NMPA
for Lynparza as a 1st-line maintenance treatment of adult
patients with newly-diagnosed advanced BRCAm epithelial ovarian,
fallopian tube or primary peritoneal cancer who are in complete or
partial response to 1st-line platinum-based chemotherapy. The
approval in China was based on results from the Phase III SOLO-1
trial.
During the period, the Company announced
that Lynparza had been approved in the US for the
maintenance treatment of adult patients with germline (inherited)
BRCAm metastatic pancreatic adenocarcinoma (pancreatic cancer)
whose disease has not progressed for at least 16 weeks of a
1st-line platinum-based chemotherapy regimen. Patients will be
selected for therapy based on a US FDA-approved companion
diagnostic for Lynparza.
The approval followed the recommendation from the US FDA Oncologic
Drugs Advisory Committee in December 2019
for Lynparza in
this indication and was based on results from the pivotal Phase III
POLO trial, published in The
New England Journal of Medicine and presented at the 2019
American Society of Clinical Oncology Annual
Meeting.
In January 2020, the Company announced that a supplemental New
Drug Application (sNDA) for Lynparza in combination with bevacizumab has been
accepted and granted Priority Review status in the US for the
maintenance treatment of patients with advanced ovarian cancer who
are in complete or partial response to 1st-line platinum-based
chemotherapy with bevacizumab. The Company also made a
regulatory submission for the same indication in Japan and achieved
regulatory submission acceptance in the EU. During the same
period, AstraZeneca also announced that an sNDA
for Lynparza had been accepted and granted Priority
Review status in the US for patients with metastatic
castration-resistant prostate cancer and homologous recombination
repair (HRR) gene mutations, who have progressed following prior
treatment with a new hormonal agent.
At the 21st European Society of Gynaecological Oncology Congress in
Athens, Greece, the Company presented further details from the
Phase III PAOLA-1 trial of maintenance Lynparza with bevacizumab in patients with newly
diagnosed, advanced ovarian cancer treated with platinum-based
chemotherapy and bevacizumab as SoC. The updated data demonstrated
that, in Stage III patients with primary debulking surgery and
residual disease, patients who had received neoadjuvant
chemotherapy and Stage IV patients, PFS was 22.0 months versus 16.6
months, with a hazard ratio of 0.65 (95% CI 0.51 -
0.82).
The Company continues to pursue the joint-venture agreement entered
into in 2015 with Fujifilm Kyowa Kirin Biologics Co., Ltd. to
develop biosimilar bevacizumab to enable the continued strategy of
novel combinations with vascular endothelial growth factor
inhibitors within the pipeline, commencing
with Lynparza and other new medicines. The Phase III AVANA
trial, which evaluated FKB238 (biosimilar bevacizumab) vs. Avastin
(bevacizumab) in patients with advanced/recurrent non-squamous
NSCLC, met the primary objective of efficacy equivalence on key
clinical parameters.
Table 27: 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
2021
|
Recruitment
completed
|
|
Phase
III
PROfound
|
Metastatic castration-resistant 2nd-line+ HRRm[58] prostate
cancer
|
SoC
(abiraterone or enzalutamide) or Lynparza
|
FPCD
Q2
2017
LPCD
Q4
2018
|
Primary
endpoint met
Priority
Review (US)
|
|
Phase
III
PAOLA-1[59]
|
Advanced
1st-line
ovarian
cancer
|
Bevacizumab
maintenance or
bevacizumab
+
Lynparza maintenance
|
FPCD
Q2
2015
LPCD
Q2
2018
|
Primary
endpoint met
Priority
Review (US)
|
|
Phase
III
GY004[60]
|
Recurrent
platinum-sensitive ovarian cancer
|
SoC
chemotherapy or Lynparza or cediranib
+ Lynparza
|
FPCD
Q1
2016
First
data
anticipated
H1
2020
|
Recruitment
ongoing
|
|
Phase
II/III
GY00563
|
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
PROpel
|
Stage
IV, advanced, castration-resistant prostate cancer
|
Abiraterone
or
abiraterone
+
Lynparza
|
FPCD
Q4
2018
First
data
anticipated
2021
|
Recruitment
ongoing
|
Enhertu (breast and other
cancers)
In December 2019, AstraZeneca announced that the US FDA had
approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the
treatment of adult patients with unresectable or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2 based regimens in the metastatic setting. This came under
the Accelerated Approval programme, based on tumour-response rate
and duration of response. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
High-level results from the positive registrational Phase II trial
DESTINY-Gastric01 also showed that Enhertu had achieved a statistically significant and
clinically meaningful improvement in the primary endpoint of
objective response rate (ORR) and a key secondary endpoint of OS in
patients with HER2-positive unresectable or metastatic gastric or
gastroesophageal junction cancer that had progressed following two
or more treatment regimens, including trastuzumab and chemotherapy.
In addition to the planned discussion with the Japan Ministry of
Health, Labour and Welfare, AstraZeneca and Daiichi Sankyo plan to
discuss the data with other health authorities.
During the period, the Company presented detailed positive data
from the global pivotal Phase II single-arm DESTINY-Breast01 trial
at the aforementioned SABCS symposium; an
accompanying article appeared
in The New
England Journal of Medicine. In the
trial, Enhertu was
investigated in patients with HER2-positive metastatic breast
cancer who received two or more prior HER2-targeted regimens. The
primary endpoint of ORR, confirmed by independent central review,
was 60.9% with Enhertu monotherapy
(5.4mg/kg). Patients had a median of six prior therapies for
metastatic disease (a range of 2-27); patients achieved a disease
control rate of 97.3%, with a median duration of response of 14.8
months and median PFS of 16.4 months. The median OS has not yet
been reached, with an estimated survival rate of 86% at one year.
The results were consistent across subgroups of
patients.
Table 28: Key Enhertu trials
|
Trial
|
Population
|
Design
|
Timeline
|
Status
|
|
Phase
II
DESTINY-Breast01
|
Stage IV, HER2+ (IHC[61] 3+
and IHC 2+/ISH[62]+)
breast cancer post trastuzumab emtansine
|
Enhertu (single arm)
|
FPCD
Q4
2017
LPCD
Q4
2018
|
Primary
objective met
Breakthrough
Therapy Designation (US)
Accelerated
approval (US)
|
|
Phase
III
DESTINY-Breast02
|
Stage
IV, HER2+ (IHC 3+ and IHC 2+/ISH+) breast cancer post trastuzumab
emtansine
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2018
First
data anticipated
2021
|
Recruitment ongoing
|
|
Phase
III
DESTINY-Breast03
|
Stage
IV, HER2+ (IHC 3+ and IHC 2+/ISH+) breast cancer
|
Trastuzumab
emtansine or Enhertu
|
FPCD
Q4
2018
First
data anticipated
2021
|
Recruitment ongoing
|
|
Phase
III
DESTINY-Breast04
|
Stage
IV, HER2-low (IHC 1+/2+) breast cancer
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2018
First
data anticipated
2021
|
Recruitment ongoing
|
|
Phase
II
DESTINY-Gastric01
|
Stage
IV, HER2+ (IHC 3+ and IHC 2+/ISH+) gastric cancer
|
SoC
chemotherapy or Enhertu
|
FPCD
Q4
2017
LPCD
Q2
2019
|
Primary
endpoint met
|
Calquence (blood cancers)
In November 2019, AstraZeneca announced that the US FDA had
approved Calquence for the treatment of adult patients with CLL
or SLL. The approval was granted under the administration's
Real-Time Oncology Review programme. Reflecting the newly
established joint Project Orbis programme, approvals in Australia
and Canada followed thereafter and, during the period, the Company
also received regulatory submission acceptance in the EU for CLL
and made a regulatory submission in Japan, for relapsed/refractory
CLL.
The approvals were based on positive results from the interim
analyses of two-Phase III clinical trials, namely ELEVATE TN in
patients with previously untreated CLL, and ASCEND in patients with
relapsed or refractory CLL. Together, the trials showed
that Calquence, in combination with obinutuzumab or as a
monotherapy, significantly reduced the relative risk of disease
progression or death versus the comparator arms in both front-line
and relapsed or refractory CLL. Across both trials, the safety and
tolerability of Calquence were consistent with its established
profile.
During the period, AstraZeneca presented results from the interim
analysis of the ELEVATE TN trial at the aforementioned 2019 ASH
meeting. The trial results demonstrated
that Calquence, combined with obinutuzumab or as monotherapy,
significantly improved PFS compared to chlorambucil plus
obinutuzumab, a standard chemo-immunotherapy treatment, in patients
with previously untreated CLL. At a median follow-up of 28.3
months, Calquence, in combination with obinutuzumab or as a
monotherapy, significantly reduced the risk of disease progression
or death by 90% and 80%, respectively, versus chlorambucil plus
obinutuzumab.
Adverse events (AEs) led to treatment discontinuation in 11.2% of
patients treated with Calquence in combination with obinutuzumab and 8.9% of
patients treated with Calquence monotherapy versus 14.1% of patients treated
with chlorambucil plus obinutuzumab. With over two years of
follow-up, 79% of patients in both the Calquence-containing arms remain
on Calquence as
a monotherapy. In the Calquence combination arm (n=178), the most common AEs
of any grade (≥30%) included headache (39.9%), diarrhoea
(38.8%) and neutropenia (31.5%). In the Calquence monotherapy arm (n=179), the most common AEs
of any grade (≥30%) included headache (36.9%) and diarrhoea
(34.6%). In the chlorambucil plus obinutuzumab arm (n=169), the
most common AEs of any grade (≥30%) included neutropenia
(45.0%), infusion-related reaction (39.6%) and
nausea.
Selumetinib (NF1)
In November 2019, the Company announced that the US FDA had
accepted a New Drug Application (NDA) and granted Priority Review
status for selumetinib as a potential new medicine for paediatric
patients aged three years and older with NF1 and symptomatic,
inoperable plexiform neurofibromas. This was the first acceptance
of a regulatory submission for an oral monotherapy for the
treatment of NF1, a rare and incurable genetic condition. A PDUFA
date is set for the second quarter of 2020.
CVRM
a) Farxiga (heart
failure)
In January 2020, the Company announced the US FDA had accepted an
sNDA and granted Priority Review status
for Farxiga to
reduce the risk of CV death or the worsening of heart failure in
adults with heart failure with reduced ejection fraction, with and
without T2D; the PDUFA date is set for the second quarter of 2020.
During the period, the Company also received regulatory submission
acceptance from the European Medicines Agency (EMA). Regulatory
submissions were also achieved in Japan and China during the
period.
b) Qtrilmet (T2D)
During the period, the Company announced that the European
Commission had approved Qtrilmet (metformin hydrochloride, saxagliptin and
dapagliflozin) modified-release tablets intended to improve
glycaemic control in adults with T2D.
c) Brilinta (stroke)
High-level results from the Phase III THALES trial showed
that 90mg Brilinta, used twice daily and taken with aspirin for 30
days, reached a statistically significant and clinically meaningful
reduction in the risk of the primary composite endpoint of stroke
and death, compared to aspirin alone.
d) Epanova (mixed
dyslipidaemia)
Following the recommendation from an independent Data Monitoring
Committee, AstraZeneca decided to terminate the Phase III STRENGTH
trial for Epanova, due to its low likelihood of demonstrating a
benefit to patients with MDL who are at increased risk of CV
disease. STRENGTH was a large-scale, global CVOT designed to
evaluate the safety and efficacy of Epanova compared
to placebo, both in combination with SoC statin
medicines.
d) Cotadutide
(NASH)
During the period, the US FDA granted Fast Track designation for
cotadutide as a treatment for NASH.
Table 29: Key large CVRM outcomes trials
|
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
|
Farxiga
|
|
|
Phase
III
DAPA-HF
|
c.4,500
patients with HF and reduced ejection fraction, with and without
T2D
|
Arm 1: Farxiga 10mg or 5 mg QD[63] +
SoC
Arm 2:
placebo + SoC
|
Time to
first occurrence of CV death or hHF or an urgent HF
visit
|
FPCD
Q1
2017
LPCD
Q4
2018
|
Primary
endpoint met
Fast
Track designation (US)
|
|
Phase
III
DELIVER
|
c.4,700
patients with HF and preserved ejection fraction, 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 anticipated 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[64] or
CV death or renal death
|
FPCD
Q1
2017
First
data anticipated 2021
|
Fast
Track designation (US)
|
|
Brilinta
|
|
|
Phase
III THEMIS
|
c.19,000 patients with T2D and CAD without a history of
MI[65] or
stroke
|
Arm 1: Brilinta 60mg BID[66]
Arm 2:
placebo BID on a background of acetylsalicylic acid if not
contra-indicated 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 stroke or transient ischaemic
attack
|
Arm
1: Brilinta 90mg
BID
Arm 2:
placebo BID on a background of acetylsalicylic acid 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
|
e) Roxadustat (anaemia)
In November 2019, AstraZeneca and FibroGen presented, during two
oral sessions, detailed results from the Phase III OLYMPUS and
ROCKIES trials at the American Society of Nephrology (ASN) Kidney
Week 2019 in Washington, DC. The results showed that roxadustat
significantly increased haemoglobin levels in non-dialysis
dependent (NDD) patients with anaemia from CKD compared to placebo,
and dialysis-dependent (DD) patients with anaemia from CKD compared
to epoetin alfa, respectively.
The companies presented pooled efficacy and CV safety analyses from
the pivotal Phase III programme during an oral late-breaking
abstract session. The primary efficacy endpoint was achieved
in the pooled analyses for NDD and DD patients, and in all
individual Phase III trials. The pooled analyses showed that
roxadustat did not increase the risk of MACE[67],
MACE+[68] and
all-cause mortality in NDD patients compared to placebo and DD
patients compared to epoetin alfa. In a clinically important
predefined subgroup of incident dialysis[69] patients,
roxadustat reduced the risk of MACE and MACE+ and showed a trend
towards lower risk of all-cause mortality relative to epoetin
alfa.
In December 2019, FibroGen announced the regulatory submission of
an NDA to the US FDA for roxadustat as a potential new medicine for
the treatment of anaemia from CKD, in both NDD and DD CKD
patients. Data from the pooled analyses, together with other
statistical analyses, formed part of the submission. The
regulatory submission was subsequently accepted by the US FDA in
February 2020 with a PDUFA date set for the fourth
quarter of 2020. Roxadustat is approved in China for the treatment
of patients with anaemia from CKD, regardless of whether they
require dialysis, and in Japan for the treatment of DD patients
with anaemia from CKD. In January 2020, FibroGen's collaborator,
Astellas, submitted in Japan an sNDA for the approval of roxadustat
as a potential treatment of anaemia from CKD in NDD
patients.
f) Lokelma (hyperkalaemia)
In January 2020, Lokelma was approved in China for the treatment of
adult patients with hyperkalaemia, (elevated levels of potassium in
the blood). The approval by the NMPA was based on positive results
from the extensive Lokelma clinical-trial programme and a
pharmacodynamic trial in China which showed that patients
receiving Lokelma experienced a significant, rapid and
sustained reduction of potassium levels in the blood. In 2019, the
NMPA included Lokelma on the Accelerated Approval list of
'Overseas New Drugs in Clinical Urgent Needs for China',
recognising the significant unmet need for effective medicines
treating hyperkalaemia. In Japan, a regulatory decision is expected
in the first half of the year.
Respiratory (and immunology)
a) Symbicort (mild asthma)
In December 2019, AstraZeneca made a regulatory submission in China
for Symbicort for the treatment of mild asthma which
contained data from the Phase III SYGMA programme, looking at the
use of Symbicort use as an anti-inflammatory reliever 'as
needed'.
b) Breztri (COPD)
In December 2019, AstraZeneca announced
that Breztri (budesonide/glycopyrronium/formoterol
fumarate) had been approved in China for the maintenance treatment
of COPD, becoming the first approval by the NMPA for a
triple-combination therapy in a pressurised metered-dose inhaler.
The approval followed designation of priority-review status and was
based on results from the Phase III KRONOS trial, in
which Breztri demonstrated a statistically significant
improvement in trough forced expiratory volume in one second
(FEV1), the regulatory endpoint for China, compared with
dual-combination therapies Bevespi (glycopyrronium/formoterol fumarate) and
PT009 (budesonide/formoterol fumarate).
Breztri was approved and
launched in Japan in the third quarter of 2019.
c) Fasenra (eosinophilic
diseases)
In the Phase IIIb ANDHI trial, Fasenra, when added to SoC, demonstrated a
statistically significant reduction in the annual rate of asthma
exacerbations when compared to placebo in patients with baseline
blood eosinophil counts greater than or equal to 150 cells per
microlitre. Safety and tolerability data were consistent with
the known profile of the medicine and full results are expected to
be presented at a forthcoming medical meeting.
Table 30: Key Fasenra trials
|
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
|
Phase
III MELTEMI
|
Asthmatic
adults (aged
18-75
years) on ICS plus LABA2 agonist
|
Fasenra 30mg Q4W SC
Fasenra 30mg Q8W SC
|
Safety
and tolerability
|
FPCD
Q2
2016
LPCD
Q1
2017
Data
anticipated
H2
2020
|
Recruitment
completed
|
|
Phase
IIIb PONENTE
|
Asthmatics (aged 18 years or older) receiving high-dose ICS plus
LABA and chronic OCS[70] with
or without additional asthma controller(s)
|
Fasenra 30mg Q8W SC
38-week
trial
|
Reduction
of OCS dose
|
FPCD
Q3
2018
LPCD
Q3
2019
Data
anticipated
H2
2020
|
Recruitment
completed
|
|
Phase
III OSTRO
|
Patients
(aged 18-75 years) with severe bilateral nasal polyposis;
symptomatic, despite SoC
|
Placebo
or Fasenra 30mg
Q8W SC
|
Nasal-polyposis
burden and reported nasal blockage
|
FPCD
Q1
2018
LPCD
Q2
2019
Data
anticipated
H2
2020
|
Recruitment
completed
|
|
Phase
III
MIRACLE
|
Severe
eosinophilic asthma (aged 12-75 years) despite background
controller medication, medium dose and high dose ICS plus LABA
± chronic oral corticosteroids (CN)
|
Placebo
or Fasenra 30mg
Q8W SC
|
Annual
asthma-exacerbation rate
|
FPCD
Q4
2017
Data
anticipated 2021+
|
Recruitment
ongoing
|
|
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 polyangiitis
|
Fasenra 30mg or
mepolizumab
3x100mg Q4W
|
Proportion of patients who achieve remission, defined as a
score[71] =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
|
HES[72]
|
Placebo
or Fasenra 30mg
Q4W SC
|
Time to
HES worsening flare or any cytotoxic and/or immuno-suppressive
therapy increase or hospitalisation
|
FPCD
Q4
2019
Data
anticipated 2021+
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
|
Phase
III
MESSINA
|
Eosinophilic
oesophagitis
|
Placebo
or Fasenra 30mg
Q4W SC
|
Proportion
of patients with a histologic response
Changes from baseline in dysphagia PRO[73]
|
Data
anticipated 2021+
|
Initiating
Orphan
Drug Designation (US)
|
e) Anifrolumab (lupus)
In November 2019, at the American College of Rheumatology Annual
Meeting in Atlanta, US, detailed results were presented from the
positive Phase III TULIP 2 trial for anifrolumab, a potential new
medicine for the treatment of moderate to severe SLE. The data
demonstrated superiority across multiple efficacy endpoints versus
placebo, with both arms receiving SoC as background treatment.
TULIP 2 data were subsequently published
in The
New England Journal of Medicine; data from the TULIP 1
trial were also presented and published simultaneously
in The
Lancet Rheumatology.
The TULIP 1 trial did not meet its primary endpoint, based on the
SLE Responder Index 4 composite measure[74].
The analyses of secondary endpoints showed, however, efficacy
consistent with TULIP 2 on BICLA[75] response,
reductions in OCS use, and improvements in skin disease activity.
Regulatory submissions for anifrolumab are expected in the second
half of 2020.
Table 31: Key anifrolumab trials
|
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
|
Phase III
TULIP 1
|
Moderate to severely-active SLE patients on background
SoC
|
Placebo or anifrolumab 150mg or 300mg i.v.
Q4W
|
Response in SLE
responder index at week 52
|
FPCD
Q4 2015
LPCD
Q4 2017
|
Primary endpoint not met
Fast Track designation (US)
|
|
Phase III
TULIP 2
|
Moderate to severely-active SLE patients on background
SoC
|
Placebo or anifrolumab 300mg i.v.
Q4W
|
Response in BICLA at week 52
|
FPCD
Q4 2015
LPCD
Q4 2017
|
Primary endpoint met
Fast Track designation (US)
|
|
Phase III
TULIP LTE[76]
|
Moderate to severely active SLE patients on background SoC who have
completed a Phase III anifrolumab trial
|
Placebo or anifrolumab 300mg i.v.
Q4W
|
Long-term safety over 152 weeks
|
FPCD
Q2 2016
LPCD
Q4 2018
Data anticipated
2021+
|
Recruitment completed
Fast Track designation (US)
|
f) Brazikumab (Crohn's disease and ulcerative
colitis)
In January 2020, it was announced that
AstraZeneca will recover the global rights to brazikumab (formerly
MEDI2070), a monoclonal antibody targeting IL-23, from Allergan.
Brazikumab is currently in a Phase IIb/III programme in Crohn's
disease and a Phase IIb trial in ulcerative colitis. AstraZeneca
and Allergan will terminate their existing
license agreement and all rights to
brazikumab will revert to AstraZeneca. The transaction is expected
to complete in the first quarter of 2020, subject to regulatory
approvals associated with AbbVie Inc.'s proposed acquisition of
Allergan and its timely completion. Under the termination
agreement, Allergan will fund up to an agreed amount, estimated to
be the total costs expected to be incurred by AstraZeneca until
completion of development for brazikumab in Crohn's disease and
ulcerative colitis, including the development of a companion
diagnostic.
Pursuant to the 2012 collaboration between Amgen Inc (Amgen) and
AstraZeneca to jointly develop and commercialise a clinical-stage
inflammation portfolio, Amgen is entitled to receive a high
single-digit to low double-digit royalty on sales of brazikumab if
approved and launched. This includes the original inventor royalty.
Other than this, AstraZeneca will own all rights and benefits
arising from the medicine with no other payments due to
Amgen.
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.
Condensed consolidated statement of comprehensive income - FY
2019
|
|
2019
|
2018
|
|
For the year ended 31 December
|
$m
|
$m
|
|
Product Sales
|
23,565
|
21,049
|
|
Collaboration Revenue
|
819
|
1,041
|
|
|
|
|
|
Total Revenue
|
24,384
|
22,090
|
|
Cost of sales
|
(4,921)
|
(4,936)
|
|
|
|
|
|
Gross Profit
|
19,463
|
17,154
|
|
Distribution costs
|
(339)
|
(331)
|
|
Research and development expense
|
(6,059)
|
(5,932)
|
|
Selling, general and administrative costs
|
(11,682)
|
(10,031)
|
|
Other operating income and expense
|
1,541
|
2,527
|
|
|
|
|
|
Operating Profit
|
2,924
|
3,387
|
|
Finance income
|
172
|
138
|
|
Finance expense
|
(1,432)
|
(1,419)
|
|
Share of after-tax losses in associates and joint
ventures
|
(116)
|
(113)
|
|
|
|
|
|
Profit Before Tax
|
1,548
|
1,993
|
|
Taxation
|
(321)
|
57
|
|
|
|
|
|
Profit for the period
|
1,227
|
2,050
|
|
|
|
|
|
Other comprehensive income
|
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
|
Remeasurement of the defined benefit pension liability
|
(364)
|
(46)
|
|
Net losses on equity investments measured at fair value through
other comprehensive income
|
(28)
|
(171)
|
|
Fair-value movements related to own credit risk on bonds designated
as fair-value through profit or loss
|
(5)
|
8
|
|
Tax on items that will not be reclassified to profit or
loss
|
21
|
56
|
|
|
(376)
|
(153)
|
|
|
|
|
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
|
Foreign exchange arising on consolidation
|
40
|
(450)
|
|
Foreign exchange arising on designating borrowings in net
investment hedges
|
(252)
|
(520)
|
|
Fair-value movements on cash flow hedges
|
(101)
|
(37)
|
|
Fair-value movements on cash flow hedges transferred to profit or
loss
|
52
|
111
|
|
Fair-value movements on derivatives designated in net investment
hedges
|
35
|
(8)
|
|
Costs of hedging
|
(47)
|
(54)
|
|
Amortisation of loss on cash flow hedge
|
-
|
1
|
|
Tax on items that may be reclassified subsequently to profit or
loss
|
38
|
51
|
|
|
(235)
|
(906)
|
|
|
|
|
|
Other comprehensive loss for the period, net of tax
|
(611)
|
(1,059)
|
|
Total comprehensive income for the period
|
616
|
991
|
|
|
|
|
|
Profit attributable to:
|
|
|
|
Owners of the Parent
|
1,335
|
2,155
|
|
Non-controlling interests
|
(108)
|
(105)
|
|
|
1,227
|
2,050
|
|
|
|
|
|
Total comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
723
|
1,097
|
|
Non-controlling interests
|
(107)
|
(106)
|
|
|
616
|
991
|
|
|
|
|
|
Basic earnings per $0.25 Ordinary Share
|
$1.03
|
$1.70
|
|
Diluted earnings per $0.25 Ordinary Share
|
$1.03
|
$1.70
|
|
|
|
|
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,301
|
1,267
|
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,301
|
1,267
|