Form 6-K ASTRAZENECA PLC For: Apr 29
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of April 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZN:
first-quarter 2020 results
AstraZeneca PLC
29 April 2020 07:00 BST
First-quarter 2020 results
Robust results in unprecedented times; leveraging scientific
expertise in the fight against COVID-19
AstraZeneca delivered a quarter of strong revenue and profit
growth, reflecting the immense efforts of supply-chain, commercial
and other colleagues around the world to get vital medicines to
patients. As part of the fight, the Company has rapidly responded
to the pandemic, firstly in China and then globally.
Pascal Soriot, Chief Executive Officer, commented:
"Our focus ensured another quarter of strong growth across every
therapy area and region. The new medicines performed extremely
well, and our pipeline continued to deliver. Standouts included
landmark news for Tagrisso, Farxiga and Koselugo, our latest oncology medicine. The progress made
on all fronts provides confidence that we will, once again, meet
our full-year commitments.
I could not be prouder of how the AstraZeneca team has responded to
the challenges of COVID-19. We moved quickly to maintain continuity
of care, contribute to society, and use our scientific expertise to
fight the pandemic. We hope our efforts to protect organs from
damage, mitigate the cytokine storm and the associated
hyperinflammatory state, and target the virus prove to be
successful."
COVID-19
The Company donated nine million face masks to support healthcare
workers around the world, delivered in collaboration with
the World Economic Forum's COVID Action Platform. AstraZeneca
also contributed to the UK Government's testing effort with a
dedicated site in Cambridge operated in collaboration with the
University of Cambridge and GlaxoSmithKline plc (GSK),
with a goal to deliver 30,000 tests a day in May 2020.
The Company has mobilised research efforts to find new ways to help
target the virus, reduce the cytokine storm, arising from an
overactive immune response, and potentially protect organs. As part
of the effort to target the virus, the Company is identifying novel
SARS-CoV-2-neutralising monoclonal antibodies that can be used for
treatment, as well as a prophylaxis against viral
infection.
AstraZeneca is evaluating the use of Calquence, approved in a number of countries for the
treatment of chronic lymphocytic leukaemia, in the Phase II CALAVI
trial, which is assessing the suppression of the cytokine storm
that inflames the lungs and other organs of some COVID-19 patients.
The Company is also looking at protecting organs in the Phase III
DARE-19 trial, assessing whether Farxiga, an oral medicine that has demonstrated
benefits in heart failure and kidney disease, can potentially
reduce organ failure. The Company has also joined the UK
Government's ACCORD-2 proof-of-concept clinical-trial platform, to
speed the development of medicines for patients with
COVID-19.
Q1 2020 financial performance
Table 1: Financial summary
|
|
Q1 2020
|
||
|
$m
|
% change
|
||
|
Actual
|
CER1
|
||
|
Total Revenue
|
6,354
|
16
|
17
|
|
Product Sales
|
6,311
|
15
|
17
|
|
Collaboration Revenue
|
43
|
69
|
70
|
|
|
|
|
|
|
Reported2 EPS3
|
$0.59
|
27
|
33
|
|
Core4 EPS
|
$1.05
|
17
|
21
|
Of the growth at CER in Total Revenue, AstraZeneca estimates a
low-to-mid single-digit percentage benefit of short-term inventory
increases in the distribution channel, longer prescriptions and
improved treatment-regimen adherence by patients, as indirect
effects of the ongoing COVID-19 pandemic. This benefit is
anticipated to reverse in the coming months.
The new medicines5 continued
to perform especially well and there was excellent progress from
the pipeline, with several regulatory approvals and particularly
significant news regarding the potential use
of Tagrisso in the adjuvant treatment of
EGFRm6 lung
cancer, as well as Farxiga in chronic kidney
disease.
Total Revenue growth of 16% (17% at CER) to $6,354m; this included
Product Sales of $6,311m (+15%, +17% at CER). Total Revenue
increased in the quarter across all three therapy
areas7 and
in every region. Highlights included:
in
Europe by 22% (25% at CER) to $1,204m; Japan Total Revenue
increased by 10% (8% at CER) to $553m
Broad Company response to COVID-19
AstraZeneca's priority during the COVID-19 global pandemic is to
continue to safely supply all of the Company's medicines to
millions of patients. A description of the specific impact on and
the actions by the Company regarding the pandemic is shown below;
for the latest AstraZeneca communications regarding COVID-19,
please click here.
Office-based colleagues are typically working from home; in a
growing number of countries that are potentially past the
pandemic's peak, however, colleagues have returned to the office,
in line with government guidelines. For supply-chain and research
and development (R&D) roles that cannot be performed from home,
AstraZeneca has put clear processes in place relating to social
distancing. In April 2020, the Company implemented voluntary
assessments of critical supply-chain and manufacturing colleagues
at three sites, using the Company's own laboratories, to rapidly
identify and isolate COVID-19 cases.
The Company did not see any material disruptions to its supply
chain in the period. AstraZeneca's manufacturing sites in China
returned to full capacity within weeks of the declared outbreak,
with little intervening impact on supply. The Company's supply
chain includes an effective inventory management policy for each
medicine, as well as robust business continuity plans (BCPs). These
plans seek to ensure that there are appropriate inventory levels of
active pharmaceutical ingredients and critical materials to ensure
manufacturing and supply continuity. AstraZeneca's approach to BCP
utilises various strategic measures, for example, inventory,
dual-supply processes, and operational agility.
Some medicines experienced particular growth in global demand in
the quarter, partly reflecting short-term inventory increases in
the distribution channel, as well as prescription-lengthening and
improved treatment-regimen adherence by patients. This growth in
the quarter was within the Company's fulfilment capability;
AstraZeneca is, however, closely monitoring fulfilment risks,
particularly within Respiratory & Immunology.
Interactions with healthcare professionals and organisations have
been significantly impacted and virtual meetings today, especially
in the US, Europe and Japan, remain predominant. As part of the
early response to the pandemic, AstraZeneca quickly expanded its
levels of digital activities, including:
In a growing number of countries that are potentially past the
pandemic's peak, face-to-face meetings with healthcare
professionals have been increasingly reinitiated.
AstraZeneca has focused on ensuring the continued safety of
patients in all of its ongoing clinical trials, while activating
continuity plans in order to minimise trial disruption from the
pandemic. Mitigation strategies included home-based treatment and
monitoring options, moving patient recruitment to less-affected
regions, and planning for accelerated recruitment once the pandemic
has receded. Having assessed the COVID-19 impact across the
pipeline, the Company does not expect material delays to
anticipated dates of late-stage and lifecycle-management news flow
in 2020 and 2021.
The impact of COVID-19 on the Company's operations is highly
uncertain and cannot be predicted with confidence and the extent of
any adverse impact on AstraZeneca's operations will depend on the
global duration, extent and severity of the pandemic. To the extent
the pandemic adversely affects AstraZeneca operations and/or
performance, the Company expects it to have the effect of
heightening many of the risks described beginning on page 246 in
the Risk section of the Annual Report and Form
20-F Information 2019, such as
those relating to the delivery of the pipeline or launch of new
medicines, the execution of the Company's commercial strategy, the
manufacturing and supply of medicines and reliance on third-party
goods and services.
In the current environment, the Directors have considered the
impact of a range of possible future COVID-19 related scenarios and
believe the Group retains sufficient liquidity to continue to
operate. As detailed in Note 1 of the Notes to the Interim
Financial Statements, the going-concern basis has been adopted in
these Condensed Consolidated Interim Financial Statements (Interim
Financial Statements). For an impact assessment on the Interim
Financial Statements, also see Note 1.
Guidance
The Company provides guidance for FY 2020 at CER on:
Guidance on Total Revenue and Core EPS reflects the changing nature
and growing strategic impact of Collaboration Revenue which, over
time, will primarily comprise potential income from existing
collaborations as follows:
- A share of gross
profits derived from sales of Enhertu 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)9
- Milestone revenue
from the MSD10 collaboration
on Lynparza
-
Smaller amounts of milestone and royalty revenue from other
marketed and pipeline medicines
The guidance below is subject to the assumption that the global
impact of the COVID-19 pandemic lasts for several more months and
is based on recent trends in the business. The Company will monitor
closely the development of the pandemic and anticipates providing
an update at the H1 2020 results. Variations in performance between
quarters can be expected to continue.
Financial guidance for FY 2020 is unchanged. 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. AstraZeneca recognises the heightened risks
and uncertainties from the impact of COVID-19 referred to
above.
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 April to December 2020 were to remain
at the average of rates seen in the quarter, it is anticipated that
there would be a low single-digit adverse impact on Total Revenue
and Core EPS. In addition, the Company's foreign-exchange rate
sensitivity analysis is contained within the operating and
financial review.
Financial summary
- Total Revenue,
comprising Product Sales and Collaboration Revenue, increased by
16% in the quarter (17% at CER) to $6,354m. Product Sales increased
by 15% (17% at CER) to $6,311m, primarily driven by the performance
of the new medicines, as well as Symbicort's double-digit growth at CER in every
region
- The Reported and Core
Gross Profit Margin11 declined
by two percentage points in the quarter to 77% and 78%
respectively. The falls reflected the impact of one-off
adjustments related to Group inventory, the growth in profit share
from the collaboration with MSD in respect
of Lynparza and an element of foreign-exchange
impact
- Reported Total Operating
Expense increased by 9% in the quarter (10% at CER) to $4,194m and
represented 66% of Total Revenue (Q1 2019: 70%); part of the rise,
also reflected in Core R&D Expense, was driven by the
investment related to Enhertu. Core Total Operating Expense increased by 7% (8%
at CER) to $3,600m and represented 57% of Total Revenue (Q1 2019:
61%); the increase was also driven by SG&A Expense related to
investment in Oncology-medicine launches and AstraZeneca's further
expansion in China. In addition, Reported SG&A Expense was
adversely impacted by intangible asset impairments, including a
$102m charge relating to Bydureon
-
The Reported Operating Profit Margin declined in the quarter by one
percentage point (stable at CER) to 19%; the Core Operating Profit
Margin also declined by one percentage point (stable at CER) to
29%
-
Reported EPS of $0.59 in the quarter, represented an increase of
27% (33% at CER); this was despite an increase in the
weighted-average number of shares to 1,312m (Q1 2019: 1,267m). Core
EPS increased by 17% (21% at CER) to $1.05
Commercial summary
Oncology
Total Revenue increased by 33% in the quarter (34% at CER) to
$2,518m.
Table 2: Select Oncology medicine performances
|
|
Q1 2020
|
||
|
$m
|
% change
|
||
|
Actual
|
CER
|
||
|
Tagrisso: Product
Sales
|
982
|
56
|
58
|
|
Imfinzi: Product
Sales
|
462
|
57
|
57
|
|
Lynparza: Product
Sales
|
397
|
67
|
69
|
|
Calquence: Product
Sales
|
88
|
n/m12
|
n/m
|
|
Enhertu: Collaboration
Revenue
|
14
|
n/m
|
n/m
|
Oncology Total Revenue increased in Emerging Markets by 45% (49% at
CER) to $711m.
New CVRM
Total Revenue increased by 7% in the quarter (8% at CER) to
$1,102m.
Table 3: Select New CVRM medicine performances
|
|
Q1 2020
|
||
|
$m
|
% change
|
||
|
Actual
|
CER
|
||
|
Farxiga: Total
Revenue
|
407
|
16
|
19
|
|
Brilinta: Product
Sales
|
408
|
17
|
19
|
|
Bydureon: Product
Sales
|
100
|
(30)
|
(29)
|
|
Lokelma: Product
Sales
|
11
|
n/m
|
n/m
|
|
Roxadustat: Collaboration Revenue
|
3
|
n/m
|
n/m
|
New CVRM Total Revenue increased in Emerging Markets by 39% in the
quarter (43% at CER) to $332m.
Respiratory & Immunology
Total Revenue increased by 21% in the quarter (22% at CER) to
$1,555m.
Table 4: Select Respiratory & Immunology medicine
performances
|
|
Q1 2020
|
||
|
$m
|
% change
|
||
|
Actual
|
CER
|
||
|
Symbicort: Product
Sales
|
790
|
35
|
36
|
|
Pulmicort: Product
Sales
|
380
|
(1)
|
-
|
|
Fasenra: Product
Sales
|
199
|
54
|
55
|
Respiratory & Immunology Total Revenue increased in Emerging
Markets by 4% (6% at CER) to $540m.
Following the launch of an authorised-generic version
of Symbicort in the US in collaboration with Prasco, LLC
(Prasco), US sales of Symbicort grew by 76% in the quarter to $310m. The
performance partly reflected an element of inventory build by
Prasco.
Emerging Markets
As the Company's largest region, at 36% of Total Revenue, Emerging
Markets' Total Revenue increased by 13% in the quarter (16% at CER)
to $2,273m, including:
Sustainability summary
Recent developments and progress against the Company's
sustainability priorities are reported below:
-
Access to healthcare: during the period, AstraZeneca announced a
donation of nine million face masks to support healthcare workers
around the world as they respond to the COVID-19 global pandemic;
more than eight million masks have already been delivered. In
addition, AstraZeneca, GSK and the University of Cambridge
announced a collaboration to support the UK Government's
five-pillar plan to boost testing
- Environmental
protection: to coincide with Earth Day on 22 April 2020, the
Company announced a new one-year collaboration focusing on water
stewardship with World Wide Fund for Nature Sweden, to identify
opportunities to improve the Company's approach and strategy
towards water stewardship. AstraZeneca's longer-term ambition is to
implement Science-Based Targets for Water, once a global
methodology is available, to lead the way on water stewardship for
the pharmaceutical industry; including the development of
industry-specific tools to assess water risk in the context
of Pharmaceuticals in the
Environment
-
Ethics and transparency: since committing to providing greater
transparency around payments to healthcare professionals and
healthcare organisations at the 2018 Annual General Meeting, the
Company has further progressed this work during the period across
Canada, the Philippines and New Zealand, while continuing to
monitor the regulatory landscape in Argentina, Chile, India and
Morocco
A more extensive sustainability update is provided later in this
announcement.
Notes
The following notes refer to pages one to six.
1.
Constant exchange rates. These are financial measures
that are not accounted for according to generally accepted
accounting principles (GAAP) because they remove the effects of
currency movements from Reported results.
2.
Reported financial measures are the financial results
presented in accordance with International Financial Reporting
Standards (IFRS), as issued by the International Accounting
Standards Board and adopted by the EU. The UK is yet to announce
its IFRS endorsement authority and is anticipated to continue to
follow the EU endorsement process for the foreseeable
future.
3.
Earnings per share.
4.
Core financial measures. These are non-GAAP financial
measures because, unlike Reported performance, they cannot be
derived directly from the information in the Group's Interim
Financial Statements. See the operating and financial review for a
definition of Core financial measures and a reconciliation of Core
to Reported financial measures.
5. Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri. The new medicines are pillars in the three
therapy areas and are important platforms for future growth. The
Total Revenue of Enhertu and roxadustat in the quarter entirely
reflected Ongoing Collaboration Revenue.
6.
Epidermal growth factor receptor mutation.
7.
Defined here as Oncology, New CVRM and Respiratory
& Immunology.
8. New Cardiovascular (CV),
Renal & Metabolism comprises Brilinta and Renal & Diabetes
medicines.
9.
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.
10.
Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the
US and Canada.
11.
Gross Profit is defined as Total Revenue minus Cost of Sales. The
calculation of Reported and Core Gross Margin excludes the impact
of Collaboration Revenue and any associated costs, thereby
reflecting the underlying performance of Product
Sales.
12.
Not meaningful.
Table 5: Pipeline highlights
The following table highlights significant developments in the
late-stage pipeline since the prior results
announcement:
|
Regulatory
approvals
|
- Imfinzi -
ES[11]-SCLC[12] (US)
- Enhertu -
breast cancer (3rd line[13],
HER2+[14])
(JP)
- Koselugo (selumetinib)
- NF1[15] (US)
- Lokelma -
hyperkalaemia (JP)
|
|
Regulatory
submission acceptances and/or submissions
|
- Lynparza -
prostate cancer (2nd line): regulatory submission (JP)
- Koselugo -
NF1: regulatory submission acceptance (EU)
|
|
Major
Phase III data readouts or other significant
developments
|
- Tagrisso -
adjuvant NSCLC[16] (EGFRm):
unblinded for overwhelming efficacy
- Imfinzi -
ES-SCLC: OS[17] confirmed
- Imfinzi +
treme - ES-SCLC: primary endpoint not met
- Imfinzi +/-
treme - bladder cancer (1st line[18]): primary
endpoints not met
- Lynparza -
prostate cancer: secondary OS endpoint met
- Lynparza -
pancreatic cancer: orphan designation (JP)
-
cediranib - ovarian cancer (2nd line[19]): primary
endpoint not met
- Farxiga -
CKD[20]:
primary endpoint met early
|
Table 6: 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
|
|
Q2 2020
|
- Imfinzi -
ES-SCLC: regulatory submission (CN)
- Lynparza -
ovarian cancer (1st line) (PAOLA-1): regulatory decision
(US)
- Lynparza -
breast cancer (BRCAm[21]): regulatory
decision (CN)
- Lynparza -
prostate cancer (2nd line): regulatory decision (US)
- Enhertu -
gastric cancer (3rd line, HER2+): regulatory
submission
- Forxiga -
T2D[22] CVOT[23]:
regulatory decision (CN)
- Farxiga -
HF[24] CVOT:
regulatory decision (US)
- Symbicort -
mild asthma: regulatory submission (EU)
- Bevespi -
COPD[25]:
regulatory decision (CN)
|
|
H2 2020
|
- Tagrisso -
adjuvant NSCLC (EGFRm): regulatory submission
- Imfinzi -
unresectable[26], Stage III NSCLC
(PACIFIC-2): data readout
- Imfinzi -
ES-SCLC: regulatory decision (EU, JP)
- Imfinzi +/-
treme - liver cancer (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[27]:
regulatory decision (EU)
- Forxiga -
HF CVOT: regulatory decision (EU, JP, CN)
- Farxiga -
CKD: regulatory submission
- Brilinta/Brilique -
CAD[28]/T2D CVOT:
regulatory decision (US, EU)
-
roxadustat - anaemia in CKD: regulatory decision (US)
- Symbicort -
mild asthma: regulatory decision (CN)
- Fasenra -
nasal polyposis[29]: data
readout
-
PT010 - COPD: regulatory decision (US, EU)
-
PT027 - asthma: data readout
-
tezepelumab - severe asthma: data readout
-
anifrolumab - lupus (SLE[30]): regulatory
submission
|
|
2021
|
- Imfinzi -
unresectable, Stage III NSCLC (PACIFIC-2): regulatory
submission
- Imfinzi -
adjuvant NSCLC: data readout, regulatory submission
- Imfinzi -
liver cancer (locoregional): data readout, regulatory
submission
- Imfinzi +/-
treme - NSCLC (1st line) (POSEIDON): data readout (OS), regulatory
submission
- Imfinzi +/-
treme - liver cancer (1st line): regulatory submission
- Imfinzi +/-
treme - head & neck cancer (1st line): data readout, regulatory
submission
- Lynparza -
adjuvant breast cancer: data readout, regulatory
submission
- Lynparza -
prostate cancer (2nd line): regulatory decision (JP)
- Lynparza -
prostate cancer (1st line, castration-resistant): data readout,
regulatory submission
- Enhertu -
breast cancer (2nd line, HER2+): data readout, regulatory
submission
- Enhertu -
breast cancer (3rd line, HER2+) (Phase III): data
readout
- Enhertu -
breast cancer (HER2-low[31]): data
readout
- Calquence -
CLL: regulatory decision (JP)
- Koselugo -
NF1: regulatory decision (EU)
-
roxadustat - anaemia in myelodysplastic syndrome[32]: 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 11:45am UK time today. Details can be accessed
via astrazeneca.com.
Report calendar
The Company intends to publish its first-half and second-quarter
financial results on 30 July 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 & Immunology. Based in
Cambridge, UK, AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
For more information, please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team,
please click
here. For Media
contacts, click
here.
Operating and financial review
All narrative on growth and results in this section is based on
actual exchange rates, and financial figures are in US$ millions
($m), unless stated otherwise. The performance shown in this
announcement covers the three-month period to 31 March 2020 (the
quarter or Q1 2020) compared to the three-month period to 31 March
2019 (Q1 2019) respectively, unless stated otherwise.
Core financial measures, EBITDA, Net Debt, Initial Collaboration
Revenue and Ongoing Collaboration Revenue are non-GAAP financial
measures because they cannot be derived directly from the Group's
Interim Financial Statements. Management believes that these
non-GAAP financial measures, when provided in combination with
Reported results, will provide investors and analysts with helpful
supplementary information to understand better the financial
performance and position of the Group on a comparable basis from
period to period. These non-GAAP financial measures are not a
substitute for, or superior to, financial measures prepared in
accordance with GAAP. Core financial measures are adjusted to
exclude certain significant items, such as:
Details on the nature of Core financial measures are provided on
page 80 of the Annual Report and Form
20-F Information 2019.
Reference should be made to the Reconciliation of Reported to Core
financial measures table included in the financial performance
section 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
Interim Financial Statements in this announcement.
Ongoing Collaboration Revenue is defined as Collaboration Revenue
excluding Initial Collaboration Revenue (which is defined as
Collaboration Revenue that is recognised at the date of completion
of an agreement or transaction, in respect of upfront
consideration). Ongoing Collaboration Revenue comprises, among
other items, royalties, milestone revenue and profit-sharing
income. Reference should be made to the Collaboration Revenue table
in this operating and financial review.
The Company strongly encourages investors and analysts not to rely
on any single financial measure, but to review AstraZeneca's
financial statements, including the Notes thereto and other
available Company reports, carefully and in their
entirety.
Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals.
Table 7: Total Revenue by therapy area
|
|
Q1 2020
|
|||
|
$m
|
|
% change
|
||
|
% of total
|
Actual
|
CER
|
||
|
Oncology
|
2,518
|
40
|
33
|
34
|
|
BioPharmaceuticals
|
2,657
|
42
|
15
|
16
|
|
New CVRM
|
1,102
|
17
|
7
|
8
|
|
Respiratory & Immunology
|
1,555
|
24
|
21
|
22
|
|
Other
medicines
|
1,179
|
19
|
(8)
|
(6)
|
|
|
|
|
|
|
|
Total
|
6,354
|
100
|
16
|
17
|
Specialty-care medicines comprise all Oncology
medicines, Brilinta, Lokelma, roxadustat and Fasenra. At 49% of Total Revenue (Q1 2019: 43%),
specialty-care medicine Total Revenue increased by 32% in the
quarter (34% at CER) to $3,139m.
Table 8: Top-ten medicines by Total Revenue
|
Medicine
|
Therapy Area
|
Q1 2020
|
|||
|
$m
|
% of total
|
% change
|
|||
|
Actual
|
CER
|
||||
|
Tagrisso
|
Oncology
|
982
|
15
|
56
|
58
|
|
Symbicort
|
Respiratory
|
790
|
12
|
35
|
36
|
|
Imfinzi
|
Oncology
|
462
|
7
|
57
|
57
|
|
Brilinta
|
CVRM
|
408
|
6
|
17
|
19
|
|
Farxiga
|
CVRM
|
407
|
6
|
16
|
19
|
|
Lynparza
|
Oncology
|
397
|
6
|
67
|
69
|
|
Pulmicort
|
Respiratory
|
380
|
6
|
(1)
|
-
|
|
Nexium
|
Other medicines
|
348
|
5
|
(6)
|
(5)
|
|
Crestor
|
CVRM
|
302
|
5
|
(10)
|
(8)
|
|
Zoladex
|
Oncology
|
228
|
4
|
16
|
19
|
|
|
|
|
|
|
|
|
Total
|
|
4,704
|
74
|
26
|
28
|
Table 9: Collaboration Revenue
|
|
Q1 2020
|
|||
|
$m
|
% of total
|
% change
|
||
|
Actual
|
CER
|
|||
|
Enhertu: profit
share
|
14
|
33
|
n/m
|
n/m
|
|
Roxadustat: profit share
|
3
|
7
|
n/m
|
n/m
|
|
Other Ongoing Collaboration Revenue
|
26
|
60
|
4
|
5
|
|
|
|
|
|
|
|
Total
|
43
|
100
|
69
|
70
|
Other Ongoing Collaboration
Revenue included Zoladex, Farxiga, Nexium OTC and other royalties. No Initial
Collaboration Revenue was recorded in the
quarter.
Total Revenue
The performance of the Company's medicines is shown below, with a
geographical split of Product Sales shown in Note 7.
Table 10: Therapy area and medicine performance
|
Therapy area
|
Medicine
|
Q1 2020
|
|||
|
$m
|
% of total
|
% change
|
|||
|
Actual
|
CER
|
||||
|
Product Sales: Oncology
|
Tagrisso
|
982
|
16
|
56
|
58
|
|
Imfinzi
|
462
|
7
|
57
|
57
|
|
|
Lynparza
|
397
|
6
|
67
|
69
|
|
|
Calquence
|
88
|
1
|
n/m
|
n/m
|
|
|
Zoladex
|
225
|
4
|
16
|
19
|
|
|
Faslodex
|
166
|
3
|
(35)
|
(34)
|
|
|
Iressa
|
77
|
1
|
(42)
|
(41)
|
|
|
Arimidex
|
50
|
1
|
(1)
|
1
|
|
|
Casodex
|
42
|
1
|
(12)
|
(10)
|
|
|
Others
|
13
|
-
|
(37)
|
(36)
|
|
|
Total Oncology
|
2,502
|
40
|
32
|
34
|
|
|
Product Sales: BioPharmaceuticals - CVRM
|
Farxiga
|
405
|
6
|
16
|
19
|
|
Brilinta
|
408
|
6
|
17
|
19
|
|
|
Bydureon
|
100
|
2
|
(30)
|
(29)
|
|
|
Onglyza
|
141
|
2
|
(8)
|
(6)
|
|
|
Byetta
|
20
|
-
|
(32)
|
(31)
|
|
|
Other diabetes
|
13
|
-
|
16
|
18
|
|
|
Lokelma
|
11
|
-
|
n/m
|
n/m
|
|
|
Crestor
|
301
|
5
|
(10)
|
(9)
|
|
|
Seloken/Toprol-XL
|
177
|
3
|
(21)
|
(18)
|
|
|
Atacand
|
66
|
1
|
33
|
36
|
|
|
Others
|
59
|
1
|
(18)
|
(17)
|
|
|
BioPharmaceuticals: total CVRM
|
1,701
|
27
|
(1)
|
1
|
|
|
Product Sales: BioPharmaceuticals - Respiratory &
Immunology
|
Symbicort
|
790
|
13
|
35
|
36
|
|
Pulmicort
|
380
|
6
|
(1)
|
-
|
|
|
Fasenra
|
199
|
3
|
54
|
55
|
|
|
Daliresp/Daxas
|
53
|
1
|
11
|
12
|
|
|
Bevespi
|
12
|
-
|
22
|
22
|
|
|
Breztri
|
4
|
-
|
n/m
|
n/m
|
|
|
Others
|
113
|
2
|
(11)
|
(10)
|
|
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,551
|
25
|
21
|
22
|
|
|
Product Sales: other medicines
|
Nexium
|
338
|
5
|
(7)
|
(6)
|
|
Synagis
|
85
|
1
|
61
|
61
|
|
|
Losec/Prilosec
|
54
|
1
|
(30)
|
(28)
|
|
|
Seroquel XR/IR
|
36
|
1
|
(4)
|
(3)
|
|
|
Others
|
44
|
1
|
(8)
|
(7)
|
|
|
Total other medicines
|
557
|
9
|
(4)
|
(3)
|
|
|
|
Total Product Sales
|
6,311
|
100
|
15
|
17
|
|
|
|
|
|
|
|
|
Total Collaboration Revenue
|
43
|
|
69
|
70
|
|
|
|
|
|
|
|
|
|
Total Revenue
|
6,354
|
|
16
|
17
|
|
Total Revenue summary
Oncology
Total Revenue of $2,518m in the quarter; an increase of 33% (34% at
CER). No Lynparza Collaboration Revenue was recorded in this
quarter. The performance of Enhertu was reflected in Collaboration Revenue; no
Product Sales of Enhertu were recorded in the
quarter.
Oncology Total Revenue represented 40% of overall Total Revenue (Q1
2019: 35%).
Tagrisso
Tagrisso has received
regulatory approval in 81 countries, including the US, China, in
the EU and Japan for the 1st-line treatment of patients with EGFRm
NSCLC. To date, reimbursement has been granted in 20 countries,
with further reimbursement decisions anticipated throughout 2020,
as well as additional regulatory decisions in many countries. This
followed Tagrisso's approval and launch in 88 countries, including
the US, China, in the EU and Japan for the treatment of patients
with EGFR T790M[33]-mutated
NSCLC.
Total Revenue, entirely comprising Product Sales, amounted to $982m
in the quarter and represented growth of 56% (58% at CER). This was
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. Sequentially, Total Revenue increased by $98m
from Q4 2019 to Q1 2020, including sequential growth in the US.
Total Revenue in the US increased by 43% year-on-year in the
quarter to $371m. Demand growth continued,
with Tagrisso established as the standard of care (SoC) in
the 1st-line setting, following regulatory approval in
2018.
In Emerging Markets, Tagrisso Total Revenue increased by 103% in the
quarter (109% at CER) to $280m, with notable growth in China,
following the admission in 2019 to the China National Drug
Reimbursement List (NRDL) in the 2nd-line
setting. Tagrisso Total Revenue in Japan increased by 25% (23%
at CER) to $153m. In Europe, Total Revenue of $162m in the quarter
represented an increase of 62% (66% at CER), driven by its emerging
use in the 1st-line setting, as more reimbursements were granted,
as well as continued strong levels of demand in the 2nd-line
setting.
Imfinzi
Imfinzi has received
regulatory approval in 62 countries, including the US, China, in
the EU and Japan for the treatment of patients with unresectable,
Stage III NSCLC whose disease has not progressed following
platinum-based chemoradiation therapy (CRT). The number of
reimbursement agreements increased to 27 in the quarter. During the
period, Imfinzi was also approved for the treatment of
ES-SCLC patients in the US and Singapore. It is also approved for
the 2nd-line treatment of patients with locally advanced or
metastatic urothelial carcinoma (bladder cancer) in 16 countries,
including in the US.
Total Revenue, entirely comprising Product Sales, amounted to $462m
in the quarter and represented growth of 57%, almost exclusively
for the treatment of unresectable, Stage III NSCLC. Total Revenue
in the US increased by 24% to $286m. In Japan, growth of 66% (64%
at CER) represented sales of $56m. Sales in Europe of $75m followed
recent regulatory approvals and launches. Imfinzi was also launched in the quarter in China
for the treatment of unresectable, Stage III
NSCLC.
Lynparza
Lynparza has received
regulatory approval 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 in the EU in April
2019. Lynparza has now been approved in 64 countries for
the treatment of metastatic breast cancer and, in four countries,
including the US, for the treatment of pancreatic
cancer.
Total Revenue amounted to $397m in the quarter and represented
growth of 67% (69% at CER); no Lynparza Collaboration Revenue was recorded in the
period. The strong performance was geographically spread, with
launches continuing in Emerging Markets and the Established Rest of
World region (RoW).
US sales amounted to $197m and increased by 66%, driven by the
launch in the 1st-line BRCAm ovarian cancer setting at the end of
2018. Lynparza continued to be the leading medicine in the
poly ADP ribose polymerase-inhibitor class, as measured by total
prescription volumes in both ovarian and breast cancer. Sales in
Europe increased by 57% (61% at CER) to $102m, driven by increasing
levels of reimbursement and BRCAm-testing rates, as well as
successful recent 1st-line ovarian cancer launches, including in
the UK and Germany.
Japan sales of Lynparza amounted to $34m, representing growth of 55%
(53% at CER). Emerging Markets sales of $56m, up by 113% (120% 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 admitted to the China NRDL for the same
indication, with effect from January 2020.
Calquence
Total Revenue, entirely comprising Product Sales, amounted to $88m
in the quarter and represented growth of 202%, with the
overwhelming majority of sales in the US. Calquence was approved by the US Food and Drug
Administration (FDA) for the treatment of CLL and small lymphocytic
lymphoma (SLL) in November 2019. Calquence has received 13 regulatory approvals for the
treatment of patients with mantle-cell lymphoma, and six in
CLL.
Enhertu
Product Sales, recorded by Daiichi Sankyo, amounted to $30m. This
reflected sales in the US, where Enhertu has been launched and where Daiichi Sankyo
is the principal. Total Revenue, entirely comprising resulting
Collaboration Revenue recorded by AstraZeneca, amounted to $14m in
the quarter, following the recent launch in the US at the beginning
of the year. Enhertu was approved by the US FDA for the treatment
of 3rd-line HER2+ breast cancer in December
2019.
Legacy: Iressa
Total Revenue, entirely comprising Product Sales, amounted to $77m
in the quarter and represented a decline of 42% (41% at CER). Sales
in Emerging Markets declined by 28% (26% at CER) to $62m,
reflecting Iressa's inclusion on the China volume-based procurement
programme.
Legacy: Faslodex
Total Revenue, entirely comprising Product Sales, amounted to $166m
in the quarter and represented a decline of 35% (34% at
CER).
Emerging Markets sales of Faslodex increased by 7% (10% at CER) to $48m. US
sales declined by 83% to $23m, reflecting the launch of multiple
generic Faslodex medicines. In Europe, where generic
competitor medicines are established, sales increased by 19% (22%
at CER) to $64m, while in Japan, sales increased by 4% (3% at CER)
to $29m.
Legacy: Zoladex
Total Revenue, predominantly comprising Product Sales, amounted to
$228m in the quarter and represented growth of 16% (19% at
CER).
Emerging Markets sales of Zoladex increased by 30% (35% at CER) to $149m.
Sales in Europe increased by 1% (3% at CER) to $35m. In the
Established RoW region, sales declined by 10% (9% at CER) to $39m,
driven by the effects of increased competition.
BioPharmaceuticals: CVRM
Total Revenue, which included roxadustat Ongoing Collaboration
Revenue of $3m and sales of Crestor and other legacy medicines, were stable in
the quarter (increase of 1% at CER) to $1,707m and represented 27%
of Total Revenue (Q1 2019: 31%).
New CVRM Total Revenue, which excluded sales
of Crestor and other legacy medicines, increased by 7%
in the quarter (8% at CER) to $1,102m, reflecting strong
performances from Farxiga and Brilinta. New CVRM Total Revenue represented 17% of
overall Total Revenue in the quarter (Q1 2019: 19%); this change
partly reflected the particular growth of
Oncology.
Farxiga
Total Revenue, predominantly comprising Product Sales, amounted to
$407m in the quarter and represented growth of 16% (19% at
CER).
Emerging Markets sales increased by 49% (55% at CER) to $141m. In
China, Farxiga was admitted to the NRDL with effect from
the start of 2020; as expected, this adversely impacted the price
of the medicine. This impact, however, was offset by the volume
benefit derived from the launch within the NRDL listing. The
performance also reflected growth in the sodium-glucose layer
transport protein 2 (SGLT2) inhibitor class at the expense of the
dipeptidyl-peptidase 4 (DPP-4) inhibitor class.
US sales declined by 14% to $113m. Growth in the quarter was
adversely affected by the impact on price from increased levels of
competition, the mix of sales and managed markets. There were,
however, favourable movements in the share of new-to-brand
prescriptions, a result of a label update in Q3 2019 to reflect
results from the DECLARE CVOT.
Sales in Europe increased by 30% (34% at CER) to $116m, partly
reflecting growth in the SGLT2 inhibitor class and an acceleration
of new-to-brand prescriptions following a similar DECLARE label
update. In Japan, sales to the collaborator, Ono Pharmaceutical
Co., Ltd, which records in-market sales, declined by 24% (25% at
CER) to $13m.
Brilinta
Total Revenue, entirely comprising Product Sales, amounted to $408m
in the quarter and represented growth of 17% (19% at CER). Patient
uptake continued in the treatment of acute coronary syndrome and
high-risk post-myocardial infarction (MI); the performance also
reflected aforementioned short-term inventory increases, given the
hospital-dispensation setting.
Emerging Markets sales of Brilinta increased by 38% (42% at CER) to $134m. US
sales of Brilinta, at $165m, represented an increase of 8%, 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 12% in the quarter
(15% at CER) to $93m, reflecting performances in Spain, Germany and
the UK.
Onglyza
Total Revenue, entirely comprising Product Sales, amounted to $141m
in the quarter and represented a decline of 8% (6% at
CER).
Sales in Emerging Markets increased by 10% (13% at CER) to $47m,
driven by the performance in China. US sales
of Onglyza declined by 14% in the quarter to $67m;
given the significant future potential of Farxiga, the Company continues to prioritise commercial
support over Onglyza. Europe sales declined by 19% (17% at CER) to
$15m, also highlighting the broader trend of a shift away from the
DPP-4 inhibitor class.
Bydureon
Total Revenue, entirely comprising Product Sales, amounted to $100m
in the quarter and represented a decline of 30% (29% at
CER).
US sales of $84m reflected a decline of 28% in the quarter,
resulting from competitive pressures and the impact of managed
markets. Patients continue to transition from the dual-chamber pen
to the BCise device. Bydureon sales in Europe fell by 34% (32% at CER) to
$12m. Reflecting the recent and potential performance
of Bydureon, a $102m intangible asset impairment charge was
recorded in the quarter.
Lokelma
Total Revenue, entirely comprising Product Sales, amounted to $11m
in the quarter and reflected sequential growth of 42% over Q4
2019.
The US represented the overwhelming majority of sales, following
the recent launch of the medicine. Lokelma led new-to-brand prescription market share
during the quarter. The medicine has received regulatory approval
in the EU, China and Japan and for the treatment of hyperkalaemia,
with further launches in several markets anticipated
soon.
Roxadustat
Total Revenue, entirely comprising Ongoing Collaboration Revenue,
amounted to $3m in the quarter. The period saw a focus on achieving
hospital listings across the country. Roxadustat was approved by
the China NMPA for the treatment of anaemia in CKD in
dialysis-dependent and non-dialysis dependent patients in December
2018 and August 2019, respectively. Roxadustat was admitted to the
China NRDL with effect from January 2020.
Legacy: Crestor
Total Revenue, predominantly comprising Product Sales, amounted to
$302m in the quarter and represented a decline of 10% (8% at
CER).
Sales in Emerging Markets declined by 15% (13% at CER) to $192m.
The performance was adversely impacted by the effect of
volume-based procurement in China. US sales increased by 9% to
$28m. In Europe, sales declined by 12% (10% at CER) to $34m. In
Japan, where AstraZeneca collaborates with Shionogi Co. Ltd, sales
increased by 5% (3% at CER) to $34m.
BioPharmaceuticals: Respiratory & Immunology
Total Revenue, which included Ongoing Collaboration Revenue of $3m
from Duaklir and Eklira, increased by 21% in the quarter (22% at CER) to
$1,555m and represented 24% of Total Revenue (Q1 2019:
23%).
Symbicort
Total Revenue, entirely comprising Product Sales, amounted to $790m
in the quarter and represented growth of 35% (36% at
CER).
An authorised-generic version of Symbicort was launched in the US by the Company's
collaborator, Prasco. US sales grew by 76% to $310m; this partly
reflected an element of inventory build by
Prasco. Symbicort also continued its global market-volume and
value leadership within the inhaled corticosteroid / long-acting
beta agonist (LABA) class. Emerging Markets sales increased by 17%
in the quarter (20% at CER) to $156m, reflecting particularly
strong performances in China and the Middle East &
Africa.
In Europe, sales increased by 7% in the quarter (10% at CER) to
$195m. In Japan, sales grew by 40% (38% at CER) to $56m, supported
by the continued effect of AstraZeneca regaining full rights,
following termination in 2019 of the Astellas co-promotion
agreement. In Japan, Symbicort pricing was, however, adversely impacted by
the recent market entry of a generic medicine.
Pulmicort
Total Revenue, entirely comprising Product Sales, amounted to $380m
in the quarter and represented a decline of 1% (stable at
CER).
Emerging Markets, where sales were stable in the quarter (+1% at
CER) at $313m, represented 82% of global Total Revenue
of Pulmicort. The performance in China was impacted by local
COVID-19 pandemic restrictions, resulting in a disruption of
hospital dispensation and significantly reduced access and
attendance to outpatient nebulisation rooms. It also reflected a
particularly benign influenza season in China, resulting in a
significantly reduced number of asthma exacerbations. Sales in the
US declined by 3% to $23m and sales in Europe increased by 3% (6%
at CER) to $26m.
Fasenra
Fasenra has received
regulatory approval in 56 countries, including in the US, the EU
and Japan for the treatment of patients with severe, uncontrolled
eosinophilic asthma. With further regulatory reviews
ongoing, Fasenra has already achieved reimbursement in 39
countries. Total Revenue, entirely comprising Product Sales,
amounted to $199m in the quarter and represented growth of 54% (55%
at CER).
Sales in the US increased by 29% in the quarter to $120m. For the
aforementioned treatment of patients, Fasenra ended the quarter as the leading novel
biologic medicine in the US, as measured by new-to-brand
prescriptions. In Europe, sales of $46m in the quarter represented
an increase of 154% (161% at CER), reflecting a number of
successful launches. Sales in Japan increased by 32% (30% at CER)
to $21m. In its approved indication and among new
patients, Fasenra obtained the leading market share of all
biologic medicines in the 'top-five' European countries and in
Japan. In Emerging Markets, sales amounted to $6m in the quarter
(Q1 2019: $nil).
Daliresp/Daxas
Total Revenue, entirely comprising Product Sales, amounted to $53m
in the quarter and represented growth of 11% (12% at
CER).
US sales, representing 85% of the global total, increased by 10% to
$45m, driven by higher demand, partially offset by adverse
inventory movements.
Bevespi
Total Revenue, entirely comprising Product Sales, amounted to $12m
in the quarter and represented growth of 22%.
Bevespi has been launched
in the US, in a number of European countries and in Japan. The
global LABA / long acting muscarinic antagonist class continued to
grow more slowly than expected.
Breztri
Total Revenue, entirely comprising Product Sales, amounted to $4m
in the quarter (Q1 2019: $nil).
Following regulatory approvals for the treatment of
COPD, Breztri was launched in Japan and
China.
Other medicines (outside the three main therapy areas)
Total Revenue, primarily comprising Product Sales, amounted to
$557m in the quarter; a decline of 4% (3% at CER). Other Total
Revenue represented 9% of overall Total Revenue (Q1 2019:
10%).
Nexium
Total Revenue, predominantly comprising Product Sales, amounted to
$348m in the quarter; a decline of 6% (5% at CER). Emerging Markets
sales of Nexium declined by 2% (an increase of 1% at CER) to
$187m. In Japan, where AstraZeneca collaborates with Daiichi
Sankyo, sales were stable at $79m.
Regional Total Revenue
Table 11: Regional Total Revenue
|
|
Q1 2020
|
|||
|
$m
|
% of total
|
% change
|
||
|
Actual
|
CER
|
|||
|
Emerging Markets
|
2,273
|
36
|
13
|
16
|
|
China
|
1,416
|
22
|
14
|
17
|
|
Ex-China
|
857
|
14
|
12
|
15
|
|
|
|
|
|
|
|
US
|
2,091
|
33
|
16
|
16
|
|
|
|
|
|
|
|
Europe
|
1,204
|
19
|
22
|
25
|
|
|
|
|
|
|
|
Established RoW
|
786
|
12
|
13
|
13
|
|
Japan
|
553
|
9
|
10
|
8
|
|
Canada
|
156
|
2
|
37
|
36
|
|
Other Established RoW
|
77
|
1
|
(1)
|
5
|
|
|
|
|
|
|
|
Total
|
6,354
|
100
|
16
|
17
|
Table 12: Emerging Markets
therapy-area performance
|
|
Q1 2020
|
|||
|
$m
|
% of total
|
% change
|
||
|
Actual
|
CER
|
|||
|
Oncology
|
711
|
31
|
45
|
49
|
|
BioPharmaceuticals
|
872
|
38
|
15
|
18
|
|
New CVRM
|
332
|
15
|
39
|
43
|
|
Respiratory & Immunology
|
540
|
24
|
4
|
6
|
|
Other medicines
|
690
|
30
|
(9)
|
(7)
|
|
|
|
|
|
|
|
Total
|
2,273
|
100
|
13
|
16
|
Table 13: Notable new-medicine
performances in Emerging Markets - Total
Revenue
|
|
Q1 2020
|
||
|
$m
|
% change
|
||
|
Actual
|
CER
|
||
|
Tagrisso
|
280
|
n/m
|
n/m
|
|
Forxiga
|
142
|
49
|
55
|
|
Brilinta
|
134
|
38
|
42
|
|
Lynparza
|
55
|
n/m
|
n/m
|
|
Imfinzi
|
33
|
n/m
|
n/m
|
The new medicines represented 29% of Emerging Markets Total Revenue
(Q1 2019: 18%). Total Revenue from specialty-care medicines
increased by 45% (50% at CER) to $854m and comprised 38% of
Emerging Markets sales in the quarter (Q1 2019: 29%).
China Total Revenue, which included $3m of roxadustat Ongoing
Collaboration Revenue, comprised 62% of Emerging Markets Total
Revenue in the quarter and increased by 14% (17% at CER) to
$1,416m.
New-medicine Total Revenue in China, primarily driven
by Tagrisso and Lynparza in Oncology and Brilinta and Farxiga in New CVRM, delivered particularly
encouraging growth and represented 27% of China Total Revenue (Q1
2019: 13%). This performance was augmented by strong sales
of Zoladex, Symbicort and a resilient performance
from Pulmicort.
Ex-China Emerging Markets, comprising entirely of Product Sales,
increased by 12% in the quarter (15% at CER) to $857m. The new
medicines represented 32% of ex-China Emerging Markets Total
Revenue in the quarter (Q1 2019: 26%), increasing by 41% (45% at
CER) to $277m. The performance was underpinned by strong levels of
growth across the following:
Table 14: Ex-China Emerging Markets:
Total Revenue
|
|
Q1 2020
|
||
|
$m
|
% change
|
||
|
Actual
|
CER
|
||
|
Russia
|
84
|
72
|
66
|
|
Brazil
|
89
|
(5)
|
6
|
|
Ex-Brazil Latin America
|
108
|
7
|
18
|
|
Ex-China Asia Pacific
|
311
|
11
|
12
|
|
Middle East and Africa
|
265
|
11
|
12
|
Financial performance
Table 15: Reported Profit and
Loss
|
|
Q1 2020
|
Q1 2019
|
% change
|
||
|
$m
|
$m
|
Actual
|
CER
|
||
|
Total Revenue
|
6,354
|
5,491
|
16
|
17
|
|
|
Product Sales
|
6,311
|
5,465
|
15
|
17
|
|
|
Collaboration Revenue
|
43
|
26
|
69
|
70
|
|
|
|
|
|
|
|
|
|
Cost of Sales
|
(1,420)
|
(1,129)
|
26
|
26
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
4,934
|
4,362
|
13
|
15
|
|
|
Gross Margin
|
77.5%
|
79.3%
|
(2)
|
(2)
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(87)
|
(78)
|
11
|
13
|
|
|
% Total Revenue
|
1.4%
|
1.4%
|
-
|
-
|
|
|
R&D Expense
|
(1,388)
|
(1,266)
|
10
|
10
|
|
|
% Total Revenue
|
21.8%
|
23.1%
|
1
|
2
|
|
|
SG&A Expense
|
(2,719)
|
(2,514)
|
8
|
9
|
|
|
% Total Revenue
|
42.8%
|
45.8%
|
3
|
3
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
480
|
593
|
(19)
|
(19)
|
|
|
% Total Revenue
|
7.6%
|
10.8%
|
(3)
|
(3)
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
1,220
|
1,097
|
11
|
16
|
|
|
Operating Profit Margin
|
19.2%
|
20.0%
|
(1)
|
-
|
|
|
|
|
|
|
|
|
|
Net Finance Expense
|
(281)
|
(312)
|
(10)
|
(9)
|
|
|
Joint Ventures and Associates
|
(4)
|
(27)
|
(85)
|
(85)
|
|
|
|
|
|
|
|
|
|
Profit Before Tax
|
935
|
758
|
23
|
29
|
|
|
|
|
|
|
|
|
|
Taxation
|
(185)
|
(195)
|
(5)
|
(1)
|
|
|
Tax Rate
|
20%
|
26%
|
|
|
|
|
|
|
|
|
||
|
Profit After Tax
|
750
|
563
|
33
|
40
|
|
|
|
|
|
|
|
|
|
EPS
|
0.59
|
0.47
|
27
|
33
|
|
Table 16: Reconciliation of Reported
Profit Before Tax to EBITDA
|
|
Q1 2020
|
Q1 2019
|
% change
|
|
|
$m
|
$m
|
Actual
|
CER
|
|
|
Reported Profit Before Tax
|
935
|
758
|
23
|
29
|
|
Net Finance Expense
|
281
|
312
|
(10)
|
(9)
|
|
Joint Ventures and Associates
|
4
|
27
|
(85)
|
(85)
|
|
Depreciation, Amortisation and Impairment
|
841
|
676
|
24
|
26
|
|
|
|
|
|
|
|
EBITDA
|
2,061
|
1,773
|
16
|
20
|
Table 17: Reconciliation of Reported
to Core financial measures
|
Q1 2020
|
Reported
|
Restructuring
|
Intangible Asset Amortisation & Impairments
|
Diabetes Alliance
|
Other
|
Core
|
Core % change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
|
|
Gross Profit
|
4,934
|
19
|
17
|
-
|
5
|
4,975
|
12
|
14
|
|
Gross Profit Margin
|
77.5%
|
|
|
|
|
78.1%
|
-2
|
-2
|
|
|
|
|
|
|
|
|
|
|
|
Distribution Expense
|
(87)
|
-
|
-
|
-
|
-
|
(87)
|
11
|
13
|
|
R&D Expense
|
(1,388)
|
11
|
42
|
-
|
(1)
|
(1,336)
|
9
|
9
|
|
SG&A Expense
|
(2,719)
|
25
|
449
|
67
|
1
|
(2,177)
|
5
|
7
|
|
Total Operating Expense
|
(4,194)
|
36
|
491
|
67
|
-
|
(3,600)
|
7
|
8
|
|
|
|
|
|
|
|
|
|
|
|
Other Operating Income & Expense
|
480
|
(2)
|
1
|
-
|
-
|
479
|
(19)
|
(19)
|
|
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
1,220
|
53
|
509
|
67
|
5
|
1,854
|
12
|
16
|
|
Operating Profit Margin
|
19.2%
|
|
|
|
|
29.2%
|
-1
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Net Finance Expense
|
(281)
|
-
|
-
|
57
|
55
|
(169)
|
(11)
|
(11)
|
|
Taxation
|
(185)
|
(11)
|
(107)
|
(31)
|
-
|
(334)
|
1
|
5
|
|
|
|
|
|
|
|
|
|
|
|
EPS
|
$0.59
|
$0.03
|
$0.31
|
$0.07
|
$0.05
|
$1.05
|
17
|
21
|
Profit and Loss summary
The increases in Reported and Core Gross Profit in the quarter
reflected the growth in Product Sales. The declines in the Reported
and Core Gross Margin partly reflected the impact of one-off
adjustments related to Group inventory, the growth in profit share
from the collaboration with MSD in respect
of Lynparza and an element of foreign-exchange
impact.
Reported Total Operating Expense in the quarter represented 66% of
Total Revenue (Q1 2019: 70%), Core Total Operating Expense
represented 57% of Total Revenue (Q1 2019: 61%).
Reported and Core R&D Expense increased partly as a result of
investment in the development of Enhertu. Reported and Core SG&A Expense grew
primarily due to additional select investment in Oncology-medicine
launches and AstraZeneca's further expansion in China. In addition,
Reported SG&A Expense was adversely impacted by an increased
level of intangible asset impairments, including a $102m charge
relating to Bydureon.
Reported and Core Other Operating Income and Expense in the quarter
included $350m of income that reflected an agreement to
divest commercial rights to a number of legacy hypertension
medicines.
The declines in Reported and Core Net Finance Expense partly
reflected a favourable movement in loan interest following the
repayment of a $1bn bond in 2019.
The Reported and Core Tax Rates for the quarter were both 20% (Q1
2019: 26% and 23% respectively). Taxation Paid for the quarter was
$477m, representing 51% of Reported Profit Before Tax (Q1 2019:
$334m, 44%).
Reported EPS of $0.59 in the quarter, represented an increase of
27% (33% at CER). This was despite an increase in the
weighted-average number of shares to 1,312m (Q1 2019: 1,267m). Core
EPS increased by 17% (21% at CER) to $1.05.
Table 18: Cash
Flow
|
|
Q1 2020
|
Q1 2019
|
Change
|
|
$m
|
$m
|
$m
|
|
|
Reported Operating Profit
|
1,220
|
1,097
|
123
|
|
Depreciation, Amortisation and Impairment
|
841
|
676
|
165
|
|
|
|
|
|
|
Increase in Working Capital and Short-Term Provisions
|
(445)
|
(710)
|
265
|
|
Gains on Disposal of Intangible Assets
|
(358)
|
(512)
|
154
|
|
Non-Cash and Other Movements
|
(462)
|
(396)
|
(66)
|
|
Interest Paid
|
(180)
|
(208)
|
28
|
|
Taxation Paid
|
(477)
|
(334)
|
(143)
|
|
|
|
|
|
|
Net Cash Inflow/(Outflow) from Operating Activities
|
139
|
(387)
|
526
|
|
Net Cash Inflow/(Outflow) before Financing Activities
|
148
|
(59)
|
207
|
|
Net Cash Outflow from Financing Activities
|
(2,362)
|
(698)
|
(1,664)
|
The increase in Net Cash Inflows from Operating Activities in the
quarter primarily reflected an underlying improvement in business
performance, combined with favourable working-capital movements.
The positive cash performance was partly offset by the
aforementioned increase in Taxation Paid.
The increase in Net Cash Inflows before Financing Activities
primarily reflected the aforementioned improvement in Net Cash
Inflows from Operating Activities, as well as a reduction in the
Purchase of Intangible Assets, partially offset by a reduction in
cash flows from the Disposal of Intangible Assets. The cash payment
of contingent consideration, in respect of the former Bristol-Myers
Squibb Company (BMS) share of the global diabetes alliance,
amounted to $124m in the quarter.
Capital Expenditure
Capital expenditure amounted to $186m in the quarter, compared to
$174m in Q1 2019. This included investment in the new AstraZeneca
R&D centre on the Biomedical Campus in Cambridge,
UK.
The Company anticipates a broadly stable level of total capital
expenditure in FY 2020 (FY 2019: $979m).
Table 19: Net Debt
summary
|
|
At 31
Mar 2020
|
At 31
Dec 2019
|
At 31
Mar 2019
|
|
$m
|
$m
|
$m
|
|
|
Cash and Cash Equivalents
|
3,413
|
5,369
|
4,136
|
|
Other Investments
|
804
|
911
|
876
|
|
|
|
|
|
|
Cash and Investments
|
4,217
|
6,280
|
5,012
|
|
|
|
|
|
|
Overdrafts and Short-Term Borrowings
|
(691)
|
(225)
|
(2,044)
|
|
Lease Liabilities
|
(653)
|
(675)
|
(714)
|
|
Current Instalments of Loans
|
(1,598)
|
(1,597)
|
(1,500)
|
|
Loans Due After One Year
|
(15,634)
|
(15,730)
|
(17,320)
|
|
|
|
|
|
|
Interest-Bearing Loans and Borrowings (Gross Debt)
|
(18,576)
|
(18,227)
|
(21,578)
|
|
|
|
|
|
|
Net Derivatives
|
(54)
|
43
|
295
|
|
Net Debt
|
(14,413)
|
(11,904)
|
(16,271)
|
Capital allocation
The Board's aim is to continue to strike a balance between the
interests of the business, financial creditors and the Company's
shareholders. After providing for investment in the business,
supporting the progressive dividend policy and maintaining a
strong, investment-grade credit rating, the Board will keep under
review potential investment in immediately earnings-accretive,
value-enhancing opportunities.
Foreign exchange
The Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies' reporting currency. Foreign-exchange
gains and losses on forward contracts for transactional hedging are
taken to profit or loss. In addition, the Company's external
dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment
date.
Table 20: Currency
sensitivities
The Company provides the following currency-sensitivity
information:
|
|
Average Exchange
Rates versus USD
|
|
Annual Impact of 5% Strengthening in Exchange Rate versus USD
($m)[35]
|
|||
|
Currency
|
Primary Relevance
|
FY 2019[36]
|
Q1 2020[37]
|
% change
|
Product Sales
|
Core Operating Profit
|
|
CNY
|
Product
Sales
|
6.92
|
6.99
|
(1)
|
288
|
190
|
|
EUR
|
Product
Sales
|
0.89
|
0.91
|
(1)
|
171
|
68
|
|
JPY
|
Product
Sales
|
108.98
|
108.91
|
-
|
139
|
98
|
|
Other[38]
|
|
|
|
|
231
|
123
|
|
|
|
|
|
|
|
|
|
GBP
|
Operating
Expense
|
0.78
|
0.78
|
-
|
27
|
(93)
|
|
SEK
|
Operating
Expense
|
9.46
|
9.67
|
(2)
|
5
|
(51)
|
Sustainability
AstraZeneca's sustainability approach has three priority
areas[39],
aligned with the Company's purpose and business
strategy:
Recent developments and progress against the Company's priorities
are reported below:
During the period, AstraZeneca announced a donation of nine million
face masks to support healthcare workers around the world as they
respond to the COVID-19 global pandemic. The Company has also
collaborated with the World Economic Forum's
COVID Action Platform, created
with the support of the World Health Organization, to identify
countries in greatest need; more than eight million masks have
already been delivered.
During the period, AstraZeneca proactively communicated with
its healthcare and
community partners, who are working to support healthcare systems,
patients and caregivers around the world, to reinforce the
Company's support of their efforts during the COVID-19 pandemic.
AstraZeneca will continue to meet funding commitments and support
community partner decisions to postpone or cancel programmes or
reallocate funding towards relief and response efforts. For
example, Healthy Heart
Africa (HHA) collaborators who support the delivery of the
Company's programme in local communities in Kenya, Ethiopia,
Tanzania and Ghana, have repurposed local
facilities and diverted resources towards providing protective
clothing to healthcare workers. AstraZeneca's Young Health
Programme partners have stopped all community-based outreach and
are delivering disease prevention messaging over virtual
networks. In addition, the
Company is ensuring that its collaborators are safe and supported
and is encouraging them to follow the appropriate governmental
guidance.
In March 2020, the manuscript 'Burden
of prehypertension among adults in Kenya: a retrospective analysis
of findings from the HHA programme' was published in the BMC Public
Health journal; this was
the third HHA manuscript published in the last twelve months. The
publication outlined the high prevalence of hypertension (HTN) and
pre-HTN in Kenya, with more than 50% of the six million screening
records analysed found to have pre-HTN, in addition to 20% with
HTN, among an average screening age of 45
years.
To coincide with Earth Day on 22 April 2020, AstraZeneca announced
a new one-year
collaboration focusing on water stewardship with World Wide Fund for Nature Sweden, to
identify opportunities to improve the Company's approach and
strategy towards water stewardship. Responsible management of
water, particularly where sites are situated in water-stressed
areas, is critical to the development and manufacture of the
Company's medicines. AstraZeneca's longer-term ambition is to
implement Science-Based Targets for Water, once a global
methodology is available, to lead the way on water stewardship for
the pharmaceutical industry; including the development of
industry-specific tools to assess water risk in the context
of Pharmaceuticals in the
Environment.
This approach will ensure that AstraZeneca is more meaningfully
contributing to the sustainable management of water resources
within river basins. The Company's water target is to maintain
absolute water use at the 2015 level through 2025. Since 2015, the
Company has developed a standard methodology to assess water risk
and stress at its global sites, which has enabled the Company to
broaden its understanding of water-related risks and opportunities
for priority investment. AstraZeneca has prioritised implementing
water-efficiency projects, identified through water audits at 11
sites, including Yelahanka, Bangalore, India; Shanghai, China; and
Canóvanas, Puerto Rico; and implemented rainwater harvesting
at five sites: Wuxi, China; Cambridge, UK; Macclesfield, UK;
Canóvanas, Puerto Rico and Frederick, US.
During the period, the AstraZeneca Green Labs initiative received
two 'My Green
Lab' certifications, reflecting the Company's
commitment to laboratory sustainability. AstraZeneca's R&D site
in Boston, US achieved Gold Level Certification for implementing
over 60% of recommended sustainable lab practices; and the
Company's R&D site in South San Francisco, US achieved Green
Level Certification, awarded for implementing over 80% of
recommended-sustainability practices. This is the highest level of
certification provided by My Green Lab, placing the Company's South
San Francisco site as one of only 10 laboratories certified at this
level, out of more than 400 worldwide. The programme is the first
of its scope in the industry, bringing together scientists,
facilities management, engineering and safety health and
environment to improve the environmental sustainability of research
laboratories. AstraZeneca's major sites in the UK and Sweden are in
scope and aim to become My Green Lab certified in the coming
months.
Since committing to providing greater transparency around payments
to healthcare professionals and healthcare organisations at the
2018 Annual General Meeting, AstraZeneca successfully progressed in
2019 the disclosure programme into an additional five markets
covering Brazil, Colombia, Korea, Mexico and Saudi Arabia. In 2020,
the Company is intending to further progress this work across
Canada, the Philippines (where enhanced legislation has been
recently passed, superseding the existing Administrative Order) and
New Zealand, while continuing to monitor the regulatory landscape
in Argentina, Chile, India and Morocco.
In March 2020, the Company released its sixth
annual Sustainability
Report via its website and
social media. The report was released in conjunction with
the Annual Report and Form
20-F Information 2019. The
report outlined progress and challenges and aims for the future.
Many of the new sustainability initiatives and programmes launched
in 2019 were a result of engagement and activism from AstraZeneca
colleagues around the world, demonstrating how sustainability is
being embedded across the organisation.
For more details on AstraZeneca's sustainability ambition, approach
and targets, please refer to the latest Sustainability Report
2019 and Sustainability Data
Summary 2019. Additional
information is available at astrazeneca.com/sustainability.
Research and development
As the COVID-19 pandemic develops, the Company will evaluate the
impact on the initiation of clinical trials, ongoing recruitment
and follow-ups. It is prudent to assume that some delays will arise
as a consequence of the pandemic. AstraZeneca does not expect
significant delays to anticipated late-stage and
lifecycle-management 2020 and 2021 news-flow dates.
A comprehensive data pack comprising AstraZeneca's pipeline of
medicines in human trials can be found in the latest
clinical-trials appendix, available on astrazeneca.com.
Highlights of developments in the Company's late-stage pipeline
since the prior results announcement are shown
below:
Table 21: 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
-
savolitinib - NSCLC[40]
CVRM
- Farxiga -
multiple indications
-
roxadustat - anaemia in CKD
Respiratory & Immunology
- Fasenra -
multiple indications
- Breztri -
asthma
-
PT027 - asthma
-
tezepelumab - severe asthma
-
nirsevimab - respiratory syncytial virus
-
anifrolumab - lupus (SLE)
-
brazikumab[41] -
inflammatory bowel disease
|
|
Total
projects
in
clinical pipeline
|
167
|
|
Oncology
Oncology: lung cancer
In April 2020, the Company announced that the ADAURA Phase III
trial for Tagrisso in the adjuvant treatment of patients with
Stage IB, II and IIIA EGFRm NSCLC with complete tumour resection
was to be unblinded early following a recommendation from an
Independent Data Monitoring Committee (IDMC), based on its
determination of overwhelming efficacy. The primary endpoint of the
trial is disease-free survival. Tagrisso was assessed against placebo for a treatment
duration of up to three years. The trial will continue to assess
the secondary endpoint of OS. In its communication to AstraZeneca,
the IDMC did not raise any new safety concerns. The data will be
presented at a forthcoming medical meeting.
Table 22: Key Tagrisso trials
in lung cancer
|
Trial
|
Population
|
Design
|
Timeline
|
Status
|
|
Phase
III
ADAURA
|
Adjuvant
EGFRm NSCLC
|
Placebo
or Tagrisso
|
FPCD[42]
Q4
2015
LPCD[43]
Q1
2019
|
Trial
unblinded early due to overwhelming efficacy
|
|
Phase
III
LAURA
|
Locally
advanced, unresectable EGFRm NSCLC
|
Placebo
or Tagrisso
|
FPCD
Q4
2018
First
data anticipated
2021+
|
Recruitment
ongoing
|
|
Phase
III
FLAURA2
|
1st-line
EGFRm NSCLC
|
Tagrisso or Tagrisso + platinum-based
chemotherapy doublet
|
FPCD
Q4
2019
First
data anticipated
2021+
|
Recruitment
ongoing
|
In March 2020, the Company announced that Imfinzi had been approved in the US as a 1st-line
treatment for adult patients with ES-SCLC in combination with SoC
chemotherapies, etoposide plus either carboplatin or cisplatin
(platinum-etoposide) utilising the fixed dose
of Imfinzi 1,500mg every three weeks, for four
cycles with chemotherapy, then every four weeks until progression.
This followed the regulatory approval in Singapore earlier in
the period.
Prior to this, AstraZeneca announced high-level results from the
final analysis of the Phase III CASPIAN trial, which showed
that Imfinzi, in combination with a choice of SoC
chemotherapies, confirmed a sustained, clinically meaningful OS
benefit for patients with ES-SCLC treated in the 1st-line setting.
The second experimental arm, testing tremelimumab, an anti-CTLA4
monoclonal antibody, added to Imfinzi and SoC, did not meet its primary endpoint
of demonstrating a statistically significant improvement in OS. In
June 2019, it was announced that the CASPIAN trial met one primary
endpoint for Imfinzi plus SoC by demonstrating a statistically
significant and clinically meaningful improvement in OS versus SoC
alone at a planned interim analysis.
During the period, AstraZeneca announced that the Phase III DANUBE
trial for Imfinzi and Imfinzi plus tremelimumab in unresectable, Stage IV
(metastatic) bladder cancer did not meet the primary endpoints of
improving OS versus SoC chemotherapy for Imfinzi monotherapy in patients whose tumour cells
and/or tumour-infiltrating immune cells express high levels
(≥25%) of PD-L1[44],
or for Imfinzi plus tremelimumab in patients regardless of
their PD-L1 expression. The safety and tolerability profiles
for Imfinzi and the combination with tremelimumab were
consistent with previous trials. The data will be presented at a
forthcoming medical meeting.
Table 23: Key Imfinzi trials
in lung cancer
|
Trial
|
Population
|
Design
|
Timeline
|
Status
|
|
Phase
III
AEGEAN
|
Neo-adjuvant
(before surgery) NSCLC
|
SoC
chemotherapy +/- Imfinzi,
followed
by
surgery,
followed by placebo or Imfinzi
|
FPCD
Q1
2019
First
data anticipated
2021+
|
Recruitment
ongoing
|
|
Phase
III
ADJUVANT
BR.31[45]
|
Stage
Ib-IIIa NSCLC
|
Placebo
or
Imfinzi
|
FPCD
Q1
2015
LPCD
Q1
2020
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-
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
OS data
anticipated
2021
|
PFS[46] primary
endpoint met
|
|
Phase
III
CASPIAN
|
ES-SCLC
|
SoC
chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
|
FPCD
Q1
2017
LPCD
Q2
2018
|
OS
primary endpoint met for Imfinzi monotherapy
arm
OS
primary endpoint not met for Imfinzi + treme
|
During the period, the AEGEAN trial in neo-adjuvant NSCLC was
expanded to include 800 patients and the primary endpoints
optimised to include event-free survival, as well as major
pathological response. The first data are now anticipated beyond
2021.
As previously announced, the POSEIDON trial
of Imfinzi and chemotherapy trial with and without
tremelimumab in 1st-line NSCLC will continue to assess the
additional primary endpoint of OS, following the positive PFS
readout in 2019, with data anticipated in 2021. The Company
anticipates presenting the trial outcomes at a forthcoming
medical meeting when the overall trial outcomes are
obtained.
Table 24: 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[47] 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[48]
|
TACE[49] 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
|
Primary
endpoints not met
|
|
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 HNSCC[50]
|
SoC
or Imfinzi or Imfinzi + treme
|
FPCD
Q4
2015
LPCD
Q1
2017
First
data
anticipated
2021
|
Recruitment
completed
|
|
Phase
III
HIMALAYA
|
Stage
IV, 1st-line unresectable HCC
|
Sorafenib
or Imfinzi or Imfinzi + treme
|
FPCD
Q4
2017
LPCD
Q4
2019
First
data
anticipated
H2
2020
|
Recruitment
completed
Orphan
Drug Designation (US)[51]
|
|
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
|
The Phase III KESTREL trial's final analysis plan
for Imfinzi with and without tremelimumab in 1st-line
HNSCC is being optimised following learnings from the EAGLE trial
in the 2nd-line HNSCC setting and learned regulatory insights; as
such the data readout is now expected in 2021.
During the period, Lynparza was added to the US National Comprehensive
Cancer Network's guidelines, in combination with bevacizumab in
ovarian cancer patients who had previously been treated with
bevacizumab.
In March 2020, the Company announced that Lynparza had been granted orphan designation in Japan
for the maintenance treatment of germline BRCAm curatively
unresectable pancreatic cancer. The Japan Ministry of Health,
Labour and Welfare (MHLW) grants the designation to medicines
intended for the treatment of diseases that affect fewer than
50,000 patients in Japan and for which there is a high unmet
medical need. During the period, the Company made a regulatory
submission in Japan for Lynparza in prostate cancer, based on data from the
Phase III PROfound trial.
In April 2020, AstraZeneca announced further positive results from
the Phase III PROfound trial of Lynparza in men with metastatic castration-resistant
prostate cancer who have a homologous recombination repair gene
mutation (HRRm) and have progressed on prior treatment with new
hormonal-agent treatments, such as enzalutamide and
abiraterone.
Table 25: 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
prostate
cancer
|
SoC
(abiraterone or enzalutamide) or Lynparza
|
FPCD
Q2
2017
LPCD
Q4
2018
|
Primary
endpoint met
Priority
Review (US)
|
|
Phase
III
PAOLA-1[52]
|
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[53]
|
Recurrent
platinum-sensitive ovarian cancer
|
SoC
chemotherapy or Lynparza or cediranib
+ Lynparza
|
FPCD
Q1
2016
LPCD
Q4
2017
|
Primary
endpoint not met
|
|
Phase
II/III
GY00553
|
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)
During the period, Daiichi Sankyo announced
that Enhertu had been approved by Japan's MHLW for the
treatment of patients with HER2+ unresectable or metastatic breast
cancer, following chemotherapy. Approval
of Enhertu was
based on the results of the pivotal Phase II DESTINY-Breast01 trial
of Enhertu monotherapy in HER2+ metastatic breast
cancer patients.
Table 26: Key Enhertu trials
|
Trial
|
Population
|
Design
|
Timeline
|
Status
|
|
Phase
II
DESTINY-Breast01
|
Stage
IV, HER2+ (IHC[54] 3+ and IHC
2+/ISH[55]+) breast cancer
post trastuzumab emtansine
|
Enhertu
(single
arm)
|
FPCD
Q4
2017
LPCD
Q4
2018
|
Primary
objective met
Breakthrough
Therapy Designation (US)
Approval
(JP), 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
|
Koselugo (NF1)
During the period, the Company announced that the US FDA has
approved the MEK 1/2 inhibitor, Koselugo (formerly selumetinib) for the
treatment of paediatric patients aged two years and older who
suffer from NF1 and symptomatic, inoperable plexiform neurofibromas
(PNs). The approval was based on positive results from the National
Cancer Institute (NCI) Cancer Therapy Evaluation Program-sponsored
Phase II SPRINT Stratum 1 trial, coordinated by the NCI's Center
for Cancer Research, Pediatric Oncology Branch. This was the first
regulatory approval anywhere in the world of a medicine for the
treatment of NF1 PNs.
During the period, Koselugo received a regulatory submission acceptance
in the EU for the treatment of NF1.
Cediranib
In March 2020, the Company announced high-level results from the
Phase III GY004 trial, led by NRG Oncology and sponsored by the US
NCI, that examined the efficacy and safety of the potential new
medicine cediranib when added to Lynparza versus platinum-based chemotherapy in
patients with platinum-sensitive relapsed ovarian cancer. The trial
did not meet the primary endpoint, in the intention-to-treat
population, of a statistically significant improvement in PFS.
Cediranib is an oral vascular endothelial growth factor receptor
inhibitor, which blocks the growth of blood vessels supporting
tumour growth.
CVRM
In March 2020, the Company announced that the DAPA-CKD Phase III
trial for Farxiga in patients with CKD would be stopped early,
following a recommendation from an IDMC, based on its determination
of overwhelming efficacy. The decision followed a routine
assessment of efficacy and safety. The Company anticipates
presentation of the data at a forthcoming medical
meeting.
During the period, the Company decided not to pursue the
application for Farxiga in type-1 diabetes in the US. This followed
a complete response letter received in
2019. Forxiga is currently approved for the treatment of
type-1 diabetes in the EU and Japan.
Table 27: 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[56] +
SoC
Arm 2:
placebo + SoC
|
Time to
first occurrence of CV death or hospitalisation due to HF or an
urgent HF visit
|
FPCD
Q1
2017
LPCD
Q4
2018
|
Primary
endpoint met
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[57] or reaching
ESRD[58] or CV death
or renal death
|
FPCD
Q1
2017
LPCD
Q1
2020
|
Trial
stopped early based on recommendation from an IDMC
Fast
Track designation (US)
|
|
Brilinta
|
|
||||
|
Phase
III THEMIS
|
c.19,000
patients with T2D and CAD without a history of MI or
stroke
|
Arm
1: Brilinta 60mg
BID[59]
Arm 2:
placebo BID on a background of aspirin if not
contra-indicated[60] 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 aspirin if not contra-indicated or
not tolerated
|
Prevention
of the composite of subsequent stroke and death at 30
days
|
FPCD
Q1
2018
LPCD
Q4
2019
|
Primary
endpoint met
|
In April 2020, the US FDA approved a label update for Lokelma to
include a dosing regimen specifically to treat hyperkalaemia
(elevated levels of potassium in the blood) in patients with
end-stage renal disease on chronic haemodialysis. The approval by
the agency was based on positive results from the Phase IIIb
DIALIZE trial.
Similarly, during the period, the Committee for Medicinal Products
for Human Use of the European Medicines Agency adopted a positive
opinion on a dosing and administration label update for Lokelma to
include patients with hyperkalaemia on stable haemodialysis. The
recommendation was also based on data from the Phase IIIb DIALIZE
trial, which showed that 41% of patients receiving Lokelma
maintained pre-dialysis potassium levels on at least three out of
four dialysis treatments after the long interdialytic interval and
did not require urgent rescue therapy. This compared with 1.0% of
patients receiving placebo, making it a statistically significant
and clinically meaningful improvement. The safety profile of
Lokelma observed in DIALIZE was consistent with previous
trials.
In March 2020, Lokelma was approved in Japan for the treatment of
patients with hyperkalaemia. The approval by the MHLW was based on
positive results from stand-alone trials in Japan and the global
clinical-trial programme. Lokelma is approved for the treatment of
hyperkalaemia in the US, EU, Canada, Hong Kong, China, Russia and
most recently, Japan.
During the period, AstraZeneca accomplished a number of regulatory
submissions for roxadustat in rest-of-world countries, including
Brazil, Chile, India, Mexico, Philippines, South Korea and Taiwan.
In addition, a regulatory submission was made to the ACSS
consortium for Australia, Canada and Singapore. FibroGen and
Astellas are responsible for European regulatory submissions,
including Switzerland.
Respiratory & Immunology
AstraZeneca has taken the opportunity to rename its Respiratory
therapy area Respiratory & Immunology. With common pathways and
underlying disease drivers across respiratory and immunology,
AstraZeneca is following the science from chronic lung diseases to
immunology-driven disease areas.
Fasenra (eosinophil-driven
diseases)
During the period, the Company announced three new trials
for Fasenra in skin diseases, adding to the five trials
already underway for the medicine in eosinophil-driven diseases
(EDDs) beyond severe asthma. In EDD, immune-system dysfunction
causes eosinophil recruitment and activation of eosinophils (a type
of white blood cell), leading to chronic local and/or systemic
inflammation. The three new trials for Fasenra in skin diseases include two Phase II trials
to assess the potential of the medicine as a treatment for atopic
dermatitis and chronic spontaneous urticaria, as well as a Phase
III trial in bullous pemphigoid (BP).
Table 28: Key Fasenra lifecycle
management trials
|
Trial
|
Population
|
Design
|
Primary endpoint(s)
|
Timeline
|
Status
|
|
Phase
III OSTRO
|
Patients
(aged 18-75 years) with severe bilateral nasal 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 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[61] =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[62]
|
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[63]
|
Data
anticipated 2021+
|
Recruitment
ongoing
Orphan
Drug Designation (US)
|
|
Phase
III
FJORD
|
BP
|
Placebo
or Fasenra 30mg
Q4W SC
|
Proportion
of patients with partial or
complete
remission of BP whilst off OCS for ≥2 months
at Week
36
|
Data
anticipated 2021+
|
Initiating
|
For more details on the development pipeline, including anticipated
timelines for regulatory submission/acceptances, please refer to
the latest Clinical Trials
Appendix available
on astrazeneca.com.
Interim Financial Statements
Table 29: Condensed consolidated statement of comprehensive income
- Q1 2020
|
For the quarter ended 31 March
|
2020
|
2019
|
|
$m
|
$m
|
|
|
Total Revenue
|
6,354
|
5,491
|
|
Product Sales
|
6,311
|
5,465
|
|
Collaboration Revenue
|
43
|
26
|
|
Cost of Sales
|
(1,420)
|
(1,129)
|
|
Gross Profit
|
4,934
|
4,362
|
|
Distribution costs
|
(87)
|
(78)
|
|
Research and development expense
|
(1,388)
|
(1,266)
|
|
Selling, general and administrative costs
|
(2,719)
|
(2,514)
|
|
Other operating income and expense
|
480
|
593
|
|
Operating Profit
|
1,220
|
1,097
|
|
Finance income
|
51
|
55
|
|
Finance expense
|
(332)
|
(367)
|
|
Share of after-tax losses in associates and joint
ventures
|
(4)
|
(27)
|
|
Profit Before Tax
|
935
|
758
|
|
Taxation
|
(185)
|
(195)
|
|
Profit for the period
|
750
|
563
|
|
Other comprehensive income
|
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
|
Remeasurement of the defined benefit pension liability
|
440
|
10
|
|
Net gains on equity investments measured at fair value through
other comprehensive income
|
171
|
120
|
|
Fair value movements related to own credit risk on bonds designated
as fair value through profit or loss
|
21
|
(1)
|
|
Tax on items that will not be reclassified to profit or
loss
|
(66)
|
(43)
|
|
|
566
|
86
|
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
|
Foreign exchange arising on consolidation
|
(608)
|
53
|
|
Foreign exchange arising on designating borrowings in net
investment hedges
|
(380)
|
(180)
|
|
Fair value movements on cash flow hedges
|
(187)
|
(54)
|
|
Fair value movements on cash flow hedges transferred to profit or
loss
|
45
|
47
|
|
Fair value movements on derivatives designated in net investment
hedges
|
60
|
3
|
|
Costs of hedging
|
(5)
|
(6)
|
|
Tax on items that may be reclassified subsequently to profit or
loss
|
73
|
23
|
|
|
(1,002)
|
(114)
|
|
Other comprehensive loss for the period, net of tax
|
(436)
|
(28)
|
|
Total comprehensive income for the period
|
314
|
535
|
|
Profit attributable to:
|
|
|
|
Owners of the Parent
|
780
|
593
|
|
Non-controlling interests
|
(30)
|
(30)
|
|
|
750
|
563
|
|
Total comprehensive income attributable to:
|
|
|
|
Owners of the Parent
|
345
|
565
|
|
Non-controlling interests
|
(31)
|
(30)
|
|
|
314
|
535
|
|
Basic earnings per $0.25 Ordinary Share
|
$0.59
|
$0.47
|
|
Diluted earnings per $0.25 Ordinary Share
|
$0.59
|
$0.47
|
|
Weighted average number of Ordinary Shares in issue
(millions)
|
1,312
|
1,267
|
|
Diluted weighted average number of Ordinary Shares in issue
(millions)
|
1,313
|
1,268
|
Table 30: Condensed consolidated
statement of financial position
|
|
At 31 Mar 2020
|
At 31 Dec 2019
|
At 31 Mar 2019
|
|
$m
|
$m
|
$m
|
|
|
Assets
|
|
|
|
|
Non-current assets
|
|
|
|
|
Property, plant and equipment
|
7,347
|
7,688
|
7,446
|
|
Right-of-use assets
|
644
|
647
|
707
|
|
Goodwill
|
11,569
|
11,668
|
11,674
|
|
Intangible assets
|
19,718
|
20,833
|
22,852
|
|
Investments in associates and joint ventures
|
44
|
58
|
76
|
|
Other investments
|
1,476
|
1,401
|
1,530
|
|
Derivative financial instruments
|
104
|
61
|
94
|
|
Other receivables
|
527
|
740
|
496
|
|
Deferred tax assets
|
2,960
|
2,718
|
2,531
|
|
|
44,389
|
45,814
|
47,406
|
|
Current assets
|
|
|
|
|
Inventories
|
3,123
|
3,193
|
3,050
|
|
Trade and other receivables
|
5,080
|
5,761
|
5,289
|
|
Other investments
|
752
|
849
|
822
|
|
Derivative financial instruments
|
61
|
36
|
234
|
|
Income tax receivable
|
262
|
285
|
118
|
|
Cash and cash equivalents
|
3,413
|
5,369
|
4,136
|
|
Assets held for sale
|
131
|
70
|
-
|
|
|
12,822
|
15,563
|
13,649
|
|
Total assets
|
57,211
|
61,377
|
61,055
|
|
Liabilities
|
|
|
|
|
Current liabilities
|
|
|
|
|
Interest-bearing loans and borrowings
|
(2,289)
|
(1,822)
|
(3,544)
|
|
Lease liabilities
|
(181)
|
(188)
|
(175)
|
|
Trade and other payables
|
(12,633)
|
(13,987)
|
(13,102)
|
|
Derivative financial instruments
|
(31)
|
(36)
|
(28)
|
|
Provisions
|
(649)
|
(723)
|
(397)
|
|
Income tax payable
|
(1,260)
|
(1,361)
|
(1,010)
|
|
|
(17,043)
|
(18,117)
|
(18,256)
|
|
Non-current liabilities
|
|
|
|
|
Interest-bearing loans and borrowings
|
(15,634)
|
(15,730)
|
(17,320)
|
|
Lease liabilities
|
(472)
|
(487)
|
(539)
|
|
Derivative financial instruments
|
(188)
|
(18)
|
(5)
|
|
Deferred tax liabilities
|
(2,501)
|
(2,490)
|
(3,267)
|
|
Retirement benefit obligations
|
(2,129)
|
(2,807)
|
(2,385)
|
|
Provisions
|
(807)
|
(841)
|
(379)
|
|
Other payables
|
(6,221)
|
(6,291)
|
(6,875)
|
|
|
(27,952)
|
(28,664)
|
(30,770)
|
|
Total liabilities
|
(44,995)
|
(46,781)
|
(49,026)
|
|
Net assets
|
12,216
|
14,596
|
12,029
|
|
Equity
|
|
|
|
|
Capital and reserves attributable to equity holders of the
Parent
|
|
|
|
|
Share capital
|
328
|
328
|
317
|
|
Share premium account
|
7,946
|
7,941
|
4,438
|
|
Other reserves
|
2,056
|
2,046
|
2,046
|
|
Retained earnings
|
448
|
2,812
|
3,682
|
|
|
10,778
|
13,127
|
10,483
|
|
Non-controlling interests
|
1,438
|
1,469
|
1,546
|
|
Total equity
|
12,216
|
14,596
|
12,029
|
Table 31: Condensed consolidated
statement of changes in equity
|
|
Share capital
|
Share premium account
|
Other reserves
|
Retained earnings
|
Total attributable to owners of the parent
|
Non-controlling interests
|
Total equity
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
|
At 1 Jan 2019
|
317
|
4,427
|
2,041
|
5,683
|
12,468
|
1,576
|
14,044
|
|
|
|
|
|
|
|
|
|
|
Adoption of new accounting standards
|
-
|
-
|
-
|
54
|
54
|
-
|
54
|
|
Profit for the period
|
-
|
-
|
-
|
593
|
593
|
(30)
|
563
|
|
Other comprehensive loss
|
-
|
-
|
-
|
(28)
|
(28)
|
-
|
(28)
|
|
Transfer to other reserves
|
-
|
-
|
5
|
(5)
|
-
|
-
|
-
|
|
Transactions with owners:
|
|
|
|
|
|
|
|
|
Dividends
|
-
|
-
|
-
|
(2,403)
|
(2,403)
|
-
|
(2,403)
|
|
Issue of Ordinary Shares
|
-
|
11
|
-
|
-
|
11
|
-
|
11
|
|
Share-based payments charge for the period
|
-
|
-
|
-
|
53
|
53
|
-
|
53
|
|
Settlement of share plan awards
|
-
|
-
|
-
|
(265)
|
(265)
|
-
|
(265)
|
|
|
|
|
|
|
|
|
|
|
Net movement
|
-
|
11
|
5
|
(2,001)
|
(1,985)
|
(30)
|
(2,015)
|
|
|
|
|
|
|
|
|
|
|
At 31 Mar 2019
|
317
|
4,438
|
2,046
|
3,682
|
10,483
|
1,546
|
12,029
|
|
|
|
|
|
|
|
|
|
|
At 1 Jan 2020
|
328
|
7,941
|
2,046
|
2,812
|
13,127
|
1,469
|
14,596
|
|
|
|
|
|
|
|
|
|
|
Profit for the period
|
-
|
-
|
-
|
780
|
780
|
(30)
|
750
|
|
Other comprehensive loss
|
-
|
-
|
-
|
(435)
|
(435)
|
(1)
|
(436)
|
|
Transfer to other reserves
|
-
|
-
|
10
|
(10)
|
-
|
-
|
-
|
|
Transactions with owners:
|
|
|
|
|
|
|
-
|
|
Dividends
|
-
|
-
|
-
|
(2,489)
|
(2,489)
|
-
|
(2,489)
|
|
Issue of Ordinary Shares
|
-
|
5
|
-
|
-
|
5
|
-
|
5
|
|
Share-based payments charge for the period
|
-
|
-
|
-
|
53
|
53
|
-
|
53
|
|
Settlement of share plan awards
|
-
|
-
|
-
|
(263)
|
(263)
|
-
|
(263)
|
|
Net movement
|
-
|
5
|
10
|
(2,364)
|
(2,349)
|
(31)
|
(2,380)
|
|
|
|
|
|
|
|
|
|
|
At 31 Mar 2020
|
328
|
7,946
|
2,056
|
448
|
10,778
|
1,438
|
12,216
|
Table 32: Condensed consolidated
statement of cash flows
|
For the quarter ended 31 March
|
2020
|
2019
|
|
$m
|
$m
|
|
|
Cash flows from operating activities
|
|
|
|
Profit Before Tax
|
935
|
758
|
|
Finance income and expense
|
281
|
312
|
|
Share of after-tax losses of associates and joint
ventures
|
4
|
27
|
|
Depreciation, amortisation and impairment
|
841
|
676
|
|
Increase in working capital and short-term provisions
|
(445)
|
(710)
|
|
Gains on disposal of intangible assets
|
(358)
|
(512)
|
|
Fair value movements on contingent consideration arising from
business combinations
|
(33)
|
8
|
|
Non-cash and other movements
|
(429)
|
(404)
|
|
Cash generated from operations
|
796
|
155
|
|
Interest paid
|
(180)
|
(208)
|
|
Tax paid
|
(477)
|
(334)
|
|
Net cash inflow/(outflow) from operating activities
|
139
|
(387)
|
|
Cash flows from investing activities
|
|
|
|
Payment of contingent consideration from business
combinations
|
(167)
|
(219)
|
|
Purchase of property, plant and equipment
|
(186)
|
(174)
|
|
Disposal of property, plant and equipment
|
-
|
28
|
|
Purchase of intangible assets
|
(190)
|
(586)
|
|
Disposal of intangible assets
|
365
|
1,071
|
|
Movement
in profit-participation liability
|
-
|
150
|
|
Purchase of non-current asset investments
|
(115)
|
(3)
|
|
Disposal of non-current asset investments
|
184
|
17
|
|
Movement in short-term investments, fixed deposits and other
investing instruments
|
98
|
20
|
|
Payments to associates and joint ventures
|
(8)
|
(12)
|
|
Interest received
|
28
|
36
|
|
Net cash inflow from investing activities
|
9
|
328
|
|
Net cash inflow/(outflow) before financing activities
|
148
|
(59)
|
|
Cash flows from financing activities
|
|
|
|
Proceeds from issue of share capital
|
6
|
11
|
|
Issue of loans
|
-
|
500
|
|
Dividends paid
|
(2,398)
|
(2,432)
|
|
Hedge contracts relating to dividend payments
|
(93)
|
26
|
|
Repayment of obligations under leases
|
(53)
|
(42)
|
|
Movement in short-term borrowings
|
176
|
1,239
|
|
Net cash outflow from financing activities
|
(2,362)
|
(698)
|
|
Net decrease in cash and cash equivalents in the
period
|
(2,214)
|
(757)
|
|
Cash and cash equivalents at the beginning of the
period
|
5,223
|
4,671
|
|
Exchange rate effects
|
(32)
|
12
|
|
Cash and cash equivalents at the end of the period
|
2,977
|
3,926
|
|
Cash and cash equivalents consist of:
|
|
|
|
Cash and cash equivalents
|
3,413
|
4,136
|
|
Overdrafts
|
(436)
|
(210)
|
|
|
2,977
|
3,926
|
Notes to the Interim Financial Statements
These unaudited Interim Financial Statements for the three months
ended 31 March 2020 have been prepared in accordance with IAS 34
'Interim Financial Reporting' as issued by the International
Accounting Standards Board (IASB) and as adopted by the EU. The UK
has yet to announce its post-Brexit IFRS-adoption authority and,
for the current time, will follow the EU approval
process.
The unaudited Interim Financial Statements for the three months
ended 31 March 2020 were approved by the Board of Directors for
release on 29 April 2020.
The annual financial statements of the Group are prepared in
accordance with IFRSs as issued by the IASB and adopted by the EU.
Except as noted below, the Interim Financial Statements have been
prepared applying the accounting policies that were applied in the
preparation of the Group's published consolidated financial
statements for the year ended 31 December 2019.
IFRS 3
An amendment to IFRS 3 'Business Combinations' relating to the
definition of a business was endorsed by the EU in April 2020 with
an effective date of 1 January 2020. The change in definition of a
business within IFRS 3 introduces an optional concentration test to
perform a simplified assessment of whether an acquired set of
activities and assets is or is not a business on a transaction by
transaction basis. This change is expected to provide more reliable
and comparable information about certain transactions as it
provides more consistency in accounting in the pharmaceutical
industry for substantially similar transactions for which, under
the previous definition, may have been accounted in different ways,
despite limited differences in substance. The Group has adopted
this amendment from the effective date.
IFRS 9, IAS 39 and IFRS 7
Amendments to IFRS 9 'Financial Instruments', IAS 39 'Financial
Instruments: Recognition and Measurement' and IFRS 7 'Financial
Instruments: Disclosures' relating to interbank offered rate (IBOR)
reform were endorsed by the EU in January 2020. The Group adopted
the amendments in the year ended 31 December 2019. The replacement
of benchmark interest rates such as the London Inter-bank Offered
Rate (IBOR) and other IBORs is a priority for global regulators.
The amendments provide relief from applying specific
hedge-accounting requirements to hedge relationships directly
affected by IBOR reform and have the effect that IBOR reform should
generally not cause hedge accounting to terminate. There is no
financial impact from the early adoption of these
amendments.
The Group has one IFRS 9 designated hedge relationship that is
potentially impacted by IBOR reform, namely a €300m
cross-currency interest-rate swap in a fair-value hedge
relationship with €300m of a €750m 0.875% 2021
non-callable bond. This swap references three-month USD LIBOR and
uncertainty arising from the Group's exposure to IBOR reform will
cease when the swap matures in 2021. The implications on the wider
business of IBOR reform will be assessed this year.
COVID-19
AstraZeneca has assessed the impact of the uncertainty presented by
the COVID-19 pandemic on the Interim Financial Statements
comprising the financial results to 31 March 2020 and the financial
position as at 31 March 2020, specifically considering the impact
on key judgements and significant estimates as detailed on page 173
of the Annual Report and 20-F
Information 2019 along
with a several other areas of increased risk.
A detailed assessment has been performed, focussing on the
following areas:
-
recoverable value of goodwill, intangible assets and property,
plant and equipment
-
impact on key assumptions used to estimate contingent consideration
liabilities
-
key assumptions used in estimating the Group's defined-benefit
pension obligations;
-
basis for estimating clinical-trial accruals
-
key assumptions used in estimating rebates, chargebacks and returns
for US Product Sales
-
valuations of unlisted equity investments
-
expected credit losses associated with changes in credit risk
relating to trade and other receivables
-
net realisable value of inventories
-
fair value of certain financial instruments
-
recoverability of deferred tax assets
Given the significant volatility experienced in the financial
markets, the assumptions used to estimate the Group's material
defined-benefit pension obligations were updated and resulted in a
$678m reduction in the Group's overall defined-benefit pension
deficit. This reduction primarily reflected declines in liability
valuations from lower-inflation expectations and higher discount
rates (due to rising long term AA corporate bond yields) and more
than offset declines in asset values, which held up relatively well
in difficult market conditions. In the UK, £79m of
deficit-recovery contributions were also paid. The sensitivity of
the Group's main defined-benefit liability valuations to changes in
assumptions is set out on page 207 of the Annual Report and Form
20-F Information 2019.
No further material accounting impacts relating to the areas
assessed above were recognised during the three-month period ending
31 March 2020.
The Group will continue to monitor these areas of increased
judgement and risk for material changes.
Going concern
The Group has considerable financial resources available. As at 31
March 2020, the Group had $8.3bn in financial resources (cash and
cash-equivalent balances of $3.4bn, $0.8bn of liquid fixed income
securities and undrawn committed bank facilities of $4.1bn, of
which $3.4bn is available until April 2022, $0.5bn is available
until November 2020 (extendable to November 2021) and $0.2bn is
available until December 2020, with only $2.5bn of borrowings due
within one year). The Group's revenues are largely derived from
sales of medicines which are covered by patents which provide a
relatively high level of resilience and predictability to cash
inflows, although government price interventions in response to
budgetary constraints are expected to continue to adversely affect
revenues in many of the mature markets. The Group, however,
anticipates new revenue streams from both recently launched
medicines and those in development, and the Group has a wide
diversity of customers and suppliers across different geographic
areas. Consequently, the Directors believe that, overall, the Group
is well placed to manage its business risks successfully. In the
current environment, the Directors have also considered the impact
of a range of possible future COVID-19 related scenarios and
believe the Group retains sufficient liquidity to continue to
operate.
Based on the above paragraph, the going-concern basis has been
adopted in these Interim Financial Statements.
Legal proceedings
The information contained in Note 5 updates the disclosures
concerning legal proceedings and contingent liabilities in the
Group's Annual Report and Form
20-F Information 2019.
Financial information
The comparative figures for the financial year ended 31 December
2019 are not the Group's statutory accounts for that financial
year. Those accounts have been reported on by the Group's auditors
and will be delivered to the registrar of companies; their report
was (i) unqualified, (ii) did not include a reference to any
matters to which the auditors drew attention by way of emphasis
without qualifying their report, and (iii) did not contain a
statement under section 498(2) or (3) of the Companies Act
2006.
In accordance with IAS 36 'Impairment of Assets', reviews for
triggers at an individual asset or cash-generating-unit level have
been conducted. This has resulted in a total impairment charge of
$117m being recorded during the three months ended 31 March 2020,
of which $102m is in relation to Bydureon (revised carrying amount of $627m). The
impairment was driven by an overall reduction in forecast Total
Revenue over the remaining asset life, reflecting expectations of
returns from promotional activities, including a level of
anticipated impact resulting from the restrictions in place due to
the COVID-19 pandemic. If Total Revenue projections
for Bydureon were to decline by a further 5% over the
forecast period, it would result in a further impairment charge of
c.$50m.
The table below provides an analysis of Net Debt and a
reconciliation of Net Cash Flow to the movement in Net Debt. The
Group monitors Net Debt as part of its capital-management policy as
described in Note 27 of the Annual Report and Form
20-F Information 2019. Net Debt
is a non-GAAP financial measure.
Table 33: Net
Debt
|
|
At 1 Jan 2020
|
Cash flow
|
Non-cash & other
|
Exchange movements
|
At 31 Mar 2020
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
|
|
Non-current instalments of loans
|
(15,730)
|
-
|
7
|
89
|
(15,634)
|
|
Non-current instalments of leases
|
(487)
|
-
|
-
|
15
|
(472)
|
|
|
|
|
|
|
|
|
Total long-term debt
|
(16,217)
|
-
|
7
|
104
|
(16,106)
|
|
|
|
|
|
|
|
|
Current instalments of loans
|
(1,597)
|
-
|
(1)
|
-
|
(1,598)
|
|
Current instalments of leases
|
(188)
|
58
|
(56)
|
5
|
(181)
|
|
Commercial paper
|
-
|
(85)
|
-
|
-
|
(85)
|
|
Bank collateral
|
(71)
|
(93)
|
-
|
-
|
(164)
|
|
Other short-term borrowings excluding overdrafts
|
(8)
|
2
|
-
|
-
|
(6)
|
|
Overdraft
|
(146)
|
(297)
|
-
|
7
|
(436)
|
|
|
|
|
|
|
|
|
Total current debt
|
(2,010)
|
(415)
|
(57)
|
12
|
(2,470)
|
|
|
|
|
|
|
|
|
Gross borrowings
|
(18,227)
|
(415)
|
(50)
|
116
|
(18,576)
|
|
|
|
|
|
|
|
|
Net derivative financial instruments
|
43
|
93
|
(190)
|
-
|
(54)
|
|
|
|
|
|
|
|
|
Net borrowings
|
(18,184)
|
(322)
|
(240)
|
116
|
(18,630)
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
5,369
|
(1,917)
|
-
|
(39)
|
3,413
|
|
Other investments - current
|
849
|
(98)
|
6
|
(5)
|
752
|
|
Other investments - non-current
|
62
|
-
|
(10)
|
-
|
52
|
|
Cash and investments
|
6,280
|
(2,015)
|
(4)
|
(44)
|
4,217
|
|
|
|
|
|
|
|
|
Net Debt
|
(11,904)
|
(2,337)
|
(244)
|
72
|
(14,413)
|
Non-cash movements in the period include fair-value adjustments
under IFRS 9.
Other investments - non-current are included within the balance of
$1,476m (31 December 2019: $1,401m) in the Condensed consolidated
statement of financial position. The equivalent GAAP measure to net
debt is 'liabilities arising from financing activities' which
excludes the amounts for cash and overdrafts, other investments and
non-financing derivatives shown above and includes the Acerta
Pharma put-option liability of $2,182m (31 December 2019: $2,146m)
shown in non-current other payables.
As detailed in the Group's most recent annual financial statements,
the principal financial instruments consist of derivative financial
instruments, other investments, trade and other receivables, cash
and cash equivalents, trade and other payables, leases and
interest-bearing loans and borrowings. There have been no changes
of significance to the categorisation or fair-value hierarchy
classification of our financial instruments from those detailed in
the Notes to the Group Financial Statements in
the Annual Report and Form
20-F Information 2019.
The Group holds certain equity investments that are categorised as
Level 3 in the fair-value hierarchy and for which fair-value gains
of $6m have been recognised in the quarter ended 31 March 2020.
These are presented in Net gains on equity investments measured at
fair value through other comprehensive income in the Condensed
consolidated statement of comprehensive income.
Financial instruments measured at fair value include $2,228m of
other investments, $2,035m held in money market funds, $327m of
loans designated at fair value through profit or loss, $332m of
loans designated in a fair value hedge relationship and ($54m) of
derivatives as at 31 March 2020. The total fair value of
interest-bearing loans and borrowings at 31 March 2020, which have
a carrying value of $18,576m in the Condensed consolidated
statement of financial position, was $20,929m. Contingent
consideration liabilities arising on business combinations have
been classified under Level 3 in the fair-value hierarchy and
movements in fair value are shown below:
Table 34: Financial
instruments
|
|
2020
|
2019
|
||
|
Diabetes alliance
|
Other
|
Total
|
Total
|
|
|
$m
|
$m
|
$m
|
$m
|
|
|
At 1 January
|
3,300
|
839
|
4,139
|
5,106
|
|
Settlements
|
(124)
|
(43)
|
(167)
|
(219)
|
|
Revaluations
|
(22)
|
(11)
|
(33)
|
8
|
|
Discount unwind
|
57
|
16
|
73
|
90
|
|
|
|
|
|
|
|
At 31 March
|
3,211
|
801
|
4,012
|
4,985
|
Contingent consideration arising from business combinations is
fair-valued using decision-tree analysis, with key inputs including
the probability of success, consideration of potential delays and
the expected levels of future revenues.
The contingent consideration balance relating to BMS's share of the
global diabetes alliance of $3,211m (31 December 2019: $3,300m)
would increase/decline by $321m with an increase/decline in sales
of 10%, as compared with the current estimates.
Included within the BMS contingent consideration liability includes
estimates of royalties payable in relation
to Bydureon. The revised Total Revenue projections
for Bydureon have also resulted in a $22m reduction in
the contingent consideration balance as at 31 March 2020. A further
5% reduction in Bydureon Total Revenue would result in an additional
$11m reduction.
AstraZeneca is involved in various legal proceedings considered
typical to its business, including litigation and investigations
relating to product liability, commercial disputes, infringement of
intellectual property rights, the validity of certain patents,
anti-trust law and sales and marketing practices. The matters
discussed below constitute the more significant developments since
publication of the disclosures concerning legal proceedings in the
Company's Annual Report and Form
20-F Information 2019 (the
Disclosures). Unless noted otherwise below or in the Disclosures,
no provisions have been established in respect of the claims
discussed below.
As discussed in the Disclosures, for the majority of claims in
which AstraZeneca is involved, it is not possible to make a
reasonable estimate of the expected financial effect, if any, that
will result from ultimate resolution of the proceedings. In these
cases, AstraZeneca discloses information with respect only to the
nature and facts of the cases, but no provision is
made.
In cases that have been settled or adjudicated, or where
quantifiable fines and penalties have been assessed and which are
not subject to appeal, or where a loss is probable and we are able
to make a reasonable estimate of the loss, AstraZeneca records the
loss absorbed or makes a provision for its best estimate of the
expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have
relied in calculating these provisions are inherently imprecise.
There can, therefore, be no assurance that any losses that result
from the outcome of any legal proceedings will not exceed the
amount of the provisions that have been booked in the accounts. The
major factors causing this uncertainty are described more fully in
the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and
enforce, its intellectual property.
Matters disclosed in respect of the first quarter of 2020 and to 29
April 2020
Patent litigation
US patent proceedings
As disclosed in February 2020, in response to Paragraph IV notices
from multiple abbreviated new drug application (ANDA) filers,
AstraZeneca filed patent-infringement lawsuits in the US District
Court for the District of Delaware. In its complaint, AstraZeneca
alleged that a generic version of Tagrisso, if approved and
marketed, would infringe a US Orange Book-listed Tagrisso patent.
No trial date has been set.
US patent proceedings
As previously disclosed, AstraZeneca has ANDA litigation against
Mylan Pharmaceuticals Inc. (Mylan) and 3M Company (3M) in the US
District Court for the Northern District of West Virginia. In the
action, AstraZeneca alleges that the defendants' generic versions
of Symbicort, if approved and marketed, would infringe various
AstraZeneca patents. Mylan and 3M allege that their proposed
generic medicines do not infringe the asserted patents and/or that
the asserted patents are invalid and/or unenforceable. The trial of
the Mylan and 3M matter is scheduled for October
2020.
US patent proceedings
In March 2020, Aether Therapeutics, Inc. filed a patent
infringement lawsuit in the US District Court for the District of
Delaware against AstraZeneca, Nektar Therapeutics and Daiichi
Sankyo relating to Movantik.
Commercial litigation
Amplimmune
As disclosed in the US in June 2017, AstraZeneca was served with a
lawsuit filed by the stockholders' agents for Amplimmune, Inc.
(Amplimmune) in Delaware State Court that alleged, among other
things, breaches of contractual obligations relating to a 2013
merger agreement between AstraZeneca and Amplimmune. Trial of the
matter was held in February 2020 and post-trial oral argument is
scheduled for June 2020.
Government investigations/proceedings
Litigation in New York
As disclosed in the US in June 2011, MedImmune received a demand
from the US Attorney's Office for the Southern District of New York
requesting certain documents related to the sales and marketing
activities of Synagis. In July 2011, MedImmune received a similar
court order to produce documents from the Office of the Attorney
General for the State of New York Medicaid and Fraud Control Unit
pursuant to what the government attorneys advised was a joint
investigation. MedImmune has co-operated with these inquiries. In
March 2017, MedImmune was served with a lawsuit filed in US
District Court for the Southern District of New York by the
Attorney General for the State of New York, alleging that MedImmune
inappropriately provided assistance to a single specialty-care
pharmacy. In September 2018, the US District Court in New York
denied MedImmune's motion to dismiss the lawsuit brought by the
Attorney General for the State of New York.
In June 2017, MedImmune was served with a lawsuit in US District
Court for the Southern District of New York by a relator under the
qui tam (whistle-blower) provisions of the federal and certain
state False Claims Acts. The lawsuit was originally filed under
seal in April 2009 and alleged that MedImmune made false claims
about Synagis. In November 2017, MedImmune was served with an
amended complaint in which relator set forth additional false
claims' allegations relating to Synagis. In September 2018, the US District Court in New
York dismissed the relator's lawsuit. In January 2019, relator
appealed the decision of the US District Court in New York. In
March 2020, the United States Court of Appeals for the Second
Circuit affirmed the US District Court's decision dismissing the
relator's lawsuit.
Qui tam litigation
As previously disclosed, in the US, in January and February 2014,
AstraZeneca was served with lawsuits filed in the US District Court
for the District of Delaware under the qui tam provisions of the
federal False Claims Act and related state statutes, alleging that
AstraZeneca directed certain employees to
promote Crestor off-label and provided unlawful remuneration
to physicians in connection with the promotion
of Crestor. The Department of Justice and all US states
declined to intervene in the lawsuits. In March 2019, AstraZeneca
filed a motion to dismiss the complaint. In February 2020, the
District Court partially granted AstraZeneca's motion to
dismiss.
Vermont US Attorney investigation
In April 2020, AstraZeneca received a Civil Investigative Demand
from the US Attorney's Office in Vermont and the Department of
Justice, Civil Division, seeking documents and information relating
to AstraZeneca's relationships with electronic health-record
vendors. AstraZeneca intends to co-operate with this
enquiry.
In April 2020, AstraZeneca completed an agreement to sublicense its
global rights to Movantik, excluding Europe, Canada and Israel, to RedHill
Biopharma (RedHill) for $67.5m. A related intangible was classified
as a current asset held for sale at 31 March
2020.
In April 2020, AstraZeneca and Circassia agreed to terminate the
development and commercialisation agreement relating
to Tudorza and Duaklir in the US. The agreement is expected to
close in Q2 2020. Upon completion, the rights to the assets will
revert to AstraZeneca in consideration for the release of amounts
outstanding under a loan agreement that arose from transactions
relating to the agreement. The loan was previously classified as a
non-current asset and has been reclassified as a current asset at
31 March 2020.
In April 2020, the Company signed and closed an agreement with
Taiyo Pharma Co. Ltd to divest the rights
to Inderal, Tenormin, Seloken and Omepral in Japan for
¥5,900m.
Table 35: Product Sales year-on-year
analysis - Q1 2020
|
|
World
|
Emerging Markets
|
US
|
Europe
|
Established RoW
|
|||||||||
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
|||||
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
Actual
|
CER
|
Actual
|
CER
|
||||||
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
982
|
56
|
58
|
280
|
n/m
|
n/m
|
371
|
43
|
162
|
62
|
66
|
169
|
27
|
26
|
|
Imfinzi
|
462
|
57
|
57
|
33
|
n/m
|
n/m
|
286
|
24
|
75
|
n/m
|
n/m
|
68
|
94
|
93
|
|
Lynparza
|
397
|
67
|
69
|
56
|
n/m
|
n/m
|
197
|
66
|
102
|
57
|
61
|
42
|
57
|
56
|
|
Calquence
|
88
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
86
|
n/m
|
-
|
-
|
-
|
1
|
n/m
|
n/m
|
|
Zoladex*
|
225
|
16
|
19
|
149
|
30
|
35
|
2
|
24
|
35
|
1
|
3
|
39
|
(10)
|
(9)
|
|
Faslodex*
|
166
|
(35)
|
(34)
|
48
|
7
|
10
|
23
|
(83)
|
64
|
19
|
22
|
31
|
7
|
5
|
|
Iressa*
|
77
|
(42)
|
(41)
|
62
|
(28)
|
(26)
|
4
|
(2)
|
5
|
(79)
|
(78)
|
6
|
(69)
|
(69)
|
|
Arimidex*
|
50
|
(1)
|
1
|
41
|
16
|
20
|
-
|
-
|
1
|
(85)
|
(85)
|
8
|
(14)
|
(15)
|
|
Casodex*
|
42
|
(12)
|
(10)
|
33
|
8
|
11
|
-
|
-
|
1
|
(84)
|
(84)
|
8
|
(37)
|
(37)
|
|
Others
|
13
|
(37)
|
(36)
|
8
|
(11)
|
(9)
|
1
|
-
|
1
|
19
|
23
|
3
|
(60)
|
(61)
|
|
Total Oncology
|
2,502
|
32
|
34
|
711
|
45
|
49
|
970
|
26
|
446
|
42
|
46
|
375
|
18
|
17
|
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
405
|
16
|
19
|
141
|
49
|
55
|
113
|
(14)
|
116
|
30
|
34
|
35
|
2
|
3
|
|
Brilinta
|
408
|
17
|
19
|
134
|
38
|
42
|
165
|
8
|
93
|
12
|
15
|
16
|
8
|
10
|
|
Bydureon
|
100
|
(30)
|
(29)
|
1
|
(41)
|
(39)
|
84
|
(28)
|
12
|
(34)
|
(32)
|
3
|
(46)
|
(44)
|
|
Onglyza
|
141
|
(8)
|
(6)
|
47
|
10
|
13
|
67
|
(14)
|
15
|
(19)
|
(17)
|
12
|
(10)
|
(10)
|
|
Byetta
|
20
|
(32)
|
(31)
|
3
|
n/m
|
n/m
|
11
|
(42)
|
4
|
(37)
|
(35)
|
2
|
(17)
|
(13)
|
|
Other diabetes
|
13
|
16
|
18
|
2
|
n/m
|
n/m
|
7
|
(9)
|
3
|
50
|
56
|
1
|
-
|
-
|
|
Lokelma
|
11
|
n/m
|
n/m
|
-
|
-
|
-
|
10
|
n/m
|
1
|
n/m
|
n/m
|
-
|
-
|
-
|
|
Roxadustat
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Crestor*
|
301
|
(10)
|
(9)
|
192
|
(15)
|
(13)
|
28
|
9
|
34
|
(12)
|
(10)
|
47
|
4
|
4
|
|
Seloken/Toprol-XL*
|
177
|
(21)
|
(18)
|
166
|
(14)
|
(11)
|
4
|
(82)
|
4
|
(29)
|
(29)
|
3
|
(2)
|
2
|
|
Atacand*
|
66
|
33
|
36
|
49
|
25
|
29
|
3
|
33
|
8
|
n/m
|
n/m
|
6
|
32
|
36
|
|
Others
|
59
|
(18)
|
(17)
|
37
|
(28)
|
(27)
|
-
|
-
|
19
|
7
|
9
|
3
|
22
|
22
|
|
BioPharmaceuticals: total CVRM
|
1,701
|
(1)
|
1
|
772
|
3
|
6
|
492
|
(12)
|
309
|
9
|
12
|
128
|
2
|
3
|
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
790
|
35
|
36
|
156
|
17
|
20
|
310
|
76
|
195
|
7
|
10
|
129
|
37
|
37
|
|
Pulmicort
|
380
|
(1)
|
-
|
313
|
-
|
1
|
23
|
(3)
|
26
|
3
|
6
|
18
|
(8)
|
(8)
|
|
Fasenra
|
199
|
54
|
55
|
6
|
-
|
-
|
120
|
29
|
46
|
n/m
|
n/m
|
27
|
53
|
53
|
|
Daliresp/Daxas
|
53
|
11
|
12
|
1
|
(8)
|
(4)
|
45
|
10
|
7
|
17
|
21
|
-
|
-
|
-
|
|
Bevespi
|
12
|
22
|
22
|
-
|
-
|
-
|
12
|
15
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Breztri
|
4
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Others
|
113
|
(11)
|
(10)
|
59
|
(14)
|
(12)
|
2
|
38
|
46
|
(15)
|
(13)
|
6
|
n/m
|
n/m
|
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,551
|
21
|
22
|
539
|
4
|
6
|
512
|
48
|
320
|
12
|
15
|
180
|
34
|
34
|
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium
|
338
|
(7)
|
(6)
|
187
|
(2)
|
1
|
40
|
(39)
|
22
|
36
|
41
|
89
|
(3)
|
(3)
|
|
Synagis
|
85
|
61
|
61
|
5
|
n/m
|
n/m
|
7
|
(72)
|
73
|
n/m
|
n/m
|
-
|
-
|
-
|
|
Losec/Prilosec
|
54
|
(30)
|
(28)
|
44
|
(14)
|
(12)
|
2
|
96
|
5
|
(74)
|
(74)
|
3
|
(47)
|
(48)
|
|
Seroquel XR/IR
|
36
|
(4)
|
(3)
|
12
|
(17)
|
(15)
|
13
|
n/m
|
8
|
(67)
|
(67)
|
3
|
(47)
|
(48)
|
|
Others
|
44
|
(8)
|
(7)
|
1
|
n/m
|
n/m
|
25
|
(9)
|
15
|
6
|
9
|
3
|
(82)
|
(82)
|
|
Total other medicines
|
557
|
(4)
|
(3)
|
249
|
-
|
2
|
87
|
(23)
|
123
|
23
|
25
|
98
|
(15)
|
(16)
|
|
Total Product Sales
|
6,311
|
15
|
17
|
2,271
|
13
|
16
|
2,061
|
15
|
1,198
|
22
|
25
|
781
|
13
|
12
|
Table 36: Product Sales quarterly sequential analysis - Q1
2020
|
|
Q1 2020
|
||
|
$m
|
% change
|
||
|
Actual
|
CER
|
||
|
Oncology
|
|
|
|
|
Tagrisso
|
982
|
11
|
11
|
|
Imfinzi
|
462
|
9
|
9
|
|
Lynparza
|
397
|
13
|
13
|
|
Calquence
|
88
|
58
|
58
|
|
Zoladex*
|
225
|
15
|
15
|
|
Faslodex*
|
166
|
-
|
-
|
|
Iressa*
|
77
|
(3)
|
(4)
|
|
Arimidex*
|
50
|
(1)
|
(2)
|
|
Casodex*
|
42
|
(2)
|
(3)
|
|
Others
|
13
|
(52)
|
(52)
|
|
Total Oncology
|
2,502
|
10
|
10
|
|
BioPharmaceuticals: CVRM
|
|
|
|
|
Farxiga
|
405
|
(3)
|
(3)
|
|
Brilinta
|
408
|
(5)
|
(5)
|
|
Bydureon
|
100
|
(28)
|
(28)
|
|
Onglyza
|
141
|
8
|
8
|
|
Byetta
|
20
|
(24)
|
(24)
|
|
Other diabetes
|
13
|
(22)
|
(22)
|
|
Lokelma
|
11
|
42
|
42
|
|
Roxadustat
|
-
|
-
|
-
|
|
Crestor*
|
301
|
2
|
1
|
|
Seloken/Toprol-XL*
|
177
|
(6)
|
(6)
|
|
Atacand*
|
66
|
11
|
12
|
|
Others
|
59
|
(21)
|
(22)
|
|
BioPharmaceuticals: total CVRM
|
1,701
|
(5)
|
(5)
|
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
Symbicort
|
790
|
11
|
11
|
|
Pulmicort
|
380
|
(8)
|
(9)
|
|
Fasenra
|
199
|
(3)
|
(3)
|
|
Daliresp/Daxas
|
53
|
(8)
|
(8)
|
|
Bevespi
|
12
|
9
|
9
|
|
Breztri
|
4
|
n/m
|
n/m
|
|
Others
|
113
|
(16)
|
(17)
|
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,551
|
1
|
1
|
|
Other medicines
|
|
|
|
|
Nexium
|
338
|
(4)
|
(4)
|
|
Synagis
|
85
|
35
|
35
|
|
Losec/Prilosec
|
54
|
18
|
17
|
|
Seroquel XR/IR
|
36
|
(12)
|
(12)
|
|
Others
|
44
|
(71)
|
(70)
|
|
Total other medicines
|
557
|
(15)
|
(15)
|
|
Total Product Sales
|
6,311
|
1
|
1
|
Table 37: Product Sales quarterly sequential analysis - FY
2019
|
|
Q1 2019
|
Q2 2019
|
Q3 2019
|
Q4 2019
|
||||||||
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
$m
|
% change
|
|||||
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
Actual
|
CER
|
|||||
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso
|
630
|
6
|
6
|
784
|
24
|
25
|
891
|
14
|
13
|
884
|
(1)
|
-
|
|
Imfinzi
|
295
|
13
|
13
|
338
|
15
|
15
|
412
|
22
|
22
|
424
|
3
|
4
|
|
Lynparza
|
237
|
13
|
13
|
283
|
19
|
20
|
327
|
16
|
15
|
351
|
7
|
8
|
|
Calquence
|
29
|
21
|
23
|
35
|
21
|
19
|
44
|
27
|
27
|
56
|
25
|
25
|
|
Faslodex*
|
254
|
(6)
|
(6)
|
267
|
5
|
6
|
205
|
(23)
|
(23)
|
166
|
(20)
|
(19)
|
|
Zoladex*
|
194
|
7
|
6
|
197
|
2
|
1
|
226
|
15
|
16
|
196
|
(14)
|
(12)
|
|
Iressa*
|
134
|
20
|
18
|
118
|
(12)
|
(11)
|
91
|
(23)
|
(22)
|
80
|
(13)
|
(12)
|
|
Arimidex*
|
51
|
11
|
10
|
60
|
18
|
17
|
63
|
5
|
5
|
51
|
(20)
|
(18)
|
|
Casodex*
|
48
|
4
|
3
|
57
|
19
|
18
|
52
|
(8)
|
(6)
|
43
|
(18)
|
(17)
|
|
Others
|
20
|
(13)
|
(14)
|
28
|
40
|
29
|
20
|
(27)
|
(22)
|
26
|
30
|
26
|
|
Total Oncology
|
1,892
|
7
|
6
|
2,167
|
15
|
15
|
2,334
|
8
|
8
|
2,274
|
(3)
|
(2)
|
|
BioPharmaceuticals: CVRM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga
|
349
|
(12)
|
(12)
|
377
|
8
|
9
|
398
|
5
|
5
|
419
|
5
|
6
|
|
Brilinta
|
348
|
(7)
|
(8)
|
389
|
12
|
12
|
416
|
7
|
8
|
428
|
3
|
3
|
|
Bydureon
|
142
|
3
|
3
|
141
|
(1)
|
-
|
127
|
(10)
|
(10)
|
139
|
9
|
10
|
|
Onglyza
|
153
|
3
|
3
|
116
|
(24)
|
(24)
|
127
|
9
|
11
|
131
|
3
|
4
|
|
Byetta
|
30
|
(6)
|
(5)
|
25
|
(17)
|
(16)
|
28
|
10
|
13
|
27
|
(2)
|
(4)
|
|
Other diabetes
|
11
|
(8)
|
(17)
|
11
|
-
|
8
|
14
|
26
|
22
|
16
|
17
|
17
|
|
Lokelma
|
-
|
n/m
|
n/m
|
2
|
n/m
|
n/m
|
4
|
n/m
|
n/m
|
8
|
87
|
74
|
|
Roxadustat
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
Crestor*
|
335
|
(5)
|
(6)
|
310
|
(7)
|
(7)
|
337
|
9
|
9
|
296
|
(12)
|
(11)
|
|
Seloken/Toprol-XL*
|
225
|
41
|
38
|
168
|
(25)
|
(25)
|
177
|
6
|
8
|
190
|
7
|
8
|
|
Atacand*
|
50
|
(14)
|
(15)
|
56
|
12
|
14
|
55
|
(1)
|
(1)
|
60
|
8
|
9
|
|
Others
|
71
|
(3)
|
(5)
|
63
|
(11)
|
(8)
|
65
|
4
|
2
|
72
|
13
|
16
|
|
BioPharmaceuticals: total CVRM
|
1,714
|
(2)
|
(3)
|
1,658
|
(3)
|
(3)
|
1,749
|
5
|
6
|
1,785
|
2
|
3
|
|
BioPharmaceuticals: Respiratory & Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
585
|
(8)
|
(8)
|
585
|
-
|
1
|
613
|
5
|
4
|
712
|
16
|
17
|
|
Pulmicort
|
383
|
(2)
|
(2)
|
333
|
(13)
|
(13)
|
337
|
1
|
3
|
413
|
22
|
23
|
|
Fasenra
|
129
|
3
|
4
|
167
|
29
|
30
|
202
|
21
|
21
|
206
|
2
|
2
|
|
Daliresp/Daxas
|
48
|
(11)
|
(12)
|
56
|
17
|
18
|
53
|
(6)
|
(7)
|
58
|
10
|
10
|
|
Bevespi
|
10
|
-
|
(5)
|
10
|
-
|
2
|
10
|
4
|
8
|
12
|
8
|
5
|
|
Breztri
|
-
|
-
|
-
|
-
|
-
|
-
|
1
|
-
|
-
|
1
|
(74)
|
(73)
|
|
Others
|
128
|
(14)
|
(12)
|
101
|
(21)
|
(23)
|
102
|
1
|
(1)
|
135
|
33
|
38
|
|
BioPharmaceuticals: total Respiratory & Immunology
|
1,283
|
(6)
|
(6)
|
1,252
|
(2)
|
(2)
|
1,319
|
5
|
6
|
1,537
|
17
|
17
|
|
Other medicines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium
|
363
|
(7)
|
(8)
|
393
|
8
|
8
|
374
|
(5)
|
(4)
|
353
|
(6)
|
(6)
|
|
Synagis
|
53
|
(79)
|
(79)
|
96
|
81
|
81
|
146
|
52
|
53
|
63
|
(57)
|
(57)
|
|
Losec/Prilosec
|
76
|
27
|
26
|
68
|
(11)
|
(10)
|
73
|
8
|
9
|
46
|
(38)
|
(38)
|
|
Seroquel XR/IR
|
37
|
(34)
|
(33)
|
32
|
(14)
|
(10)
|
82
|
n/m
|
n/m
|
40
|
(50)
|
(49)
|
|
Others
|
47
|
(65)
|
(64)
|
52
|
11
|
11
|
56
|
8
|
-
|
151
|
n/m
|
n/m
|
|
Total other medicines
|
576
|
(35)
|
(36)
|
641
|
11
|
12
|
731
|
14
|
14
|
653
|
(11)
|
(10)
|
|
Total Product Sales
|
5,465
|
(5)
|
(6)
|
5,718
|
5
|
5
|
6,132
|
7
|
8
|
6,250
|
2
|
3
|
Table 38: Historic Collaboration
Revenue
|
|
|
Q1 2020
|
Q1 2019
|
FY 2019
|
FY 2018
|
|
$m
|
$m
|
$m
|
$m
|
||
|
Initial Collaboration Revenue
|
Crestor (Spain)
|
-
|
-
|
-
|
61
|
|
Ongoing Collaboration Revenue
|
Lynparza: regulatory
milestones
|
-
|
-
|
60
|
140
|
|
Lynparza: sales
milestones
|
-
|
-
|
450
|
250
|
|
|
Lynparza/selumetinib: option
payments
|
-
|
-
|
100
|
400
|
|
|
Crestor (Spain)
|
-
|
-
|
39
|
|
|
|
Enhertu: profit
share
|
14
|
-
|
-
|
-
|
|
|
Roxadustat: profit share
|
3
|
-
|
-
|
-
|
|
|
Royalty income
|
17
|
16
|
62
|
49
|
|
|
|
Other Collaboration Revenue
|
9
|
10
|
108
|
141
|
|
|
Total
|
43
|
26
|
819
|
1,041
|
Table 39: Other Operating Income and
Expense
The table below provides an analysis of Reported Other Operating
Income and Expense.
|
Divestment/other
|
Q1 2020
|
Q1 2019
|
FY 2019
|
FY 2018
|
|
$m
|
$m
|
$m
|
$m
|
|
|
Hypertension medicines (ex-US, India and Japan)
|
350
|
-
|
-
|
-
|
|
Synagis (US)
|
-
|
515
|
515
|
-
|
|
Losec (ex-China, Japan, US
and Mexico)
|
-
|
-
|
243
|
-
|
|
Seroquel and Seroquel XR (US, Canada, Europe and
Russia)
|
-
|
-
|
213
|
-
|
|
Arimidex and Casodex (various countries)
|
-
|
-
|
181
|
-
|
|
Nexium (Europe)
and Vimovo (ex-US)
|
-
|
-
|
-
|
728
|
|
Seroquel
|
-
|
-
|
-
|
527
|
|
Legal settlement[67]
|
-
|
-
|
-
|
346
|
|
Atacand
|
-
|
-
|
-
|
210
|
|
Anaesthetics
|
-
|
-
|
-
|
172
|
|
Alvesco, Omnaris and Zetonna
|
-
|
-
|
-
|
139
|
|
Other
|
130
|
78
|
389
|
405
|
|
Total
|
480
|
593
|
1,541
|
2,527
|
Shareholder information
|
Announcement of
first half and second quarter
results
30 July
2020
|
|
|
|
Announcement of
year to date and third quarter
results
5 November
2020
|
|
|
|
|
||
|
Future
dividends will normally be paid as follows:
|
||
|
First
interim:
|
announced
with half-year and second-quarter results and paid in
September
|
|
|
Second
interim:
|
announced
with full-year and fourth-quarter results and paid in
March
|
|
|
|
|
|
The record date for the first interim dividend for 2020, payable on
14 September 2020, will be 14 August 2020. The ex-dividend date
will be 13 August 2020.
Trademarks of the AstraZeneca group of companies appear throughout
this document in italics. Medical publications also appear
throughout the document in italics. AstraZeneca, the AstraZeneca
logotype and the AstraZeneca symbol are all trademarks of the
AstraZeneca group of companies. Trademarks of companies other than
AstraZeneca that appear in this document
include Alvesco, Omnaris and Zetonna, trademarks of Covis
Pharma; Atacand, owned by AstraZeneca or Cheplapharm (depending
on geography); Duaklir, Eklira and Tudorza, trademarks of Almirall,
S.A.; Enhertu, a trade mark of Daiichi
Sankyo;
Inderal and Tenormin, owned by AstraZeneca, Atnahs Pharma or Taiyo
Pharma Co. Ltd (depending on geography); Losec and Omepral, owned by AstraZeneca, Cheplapharm or Taiyo
Pharma Co. Ltd (depending on geography); Seloken, owned by AstraZeneca or Taiyo Pharma Co. Ltd
(depending on geography); Synagis, owned by Arexis AB or AbbVie Inc. (depending on
geography); Vimovo, owned by AstraZeneca or Grünenthal GmbH
(depending on geography).
Information on or accessible through AstraZeneca's websites,
including astrazeneca.com,
does not form part of and is not incorporated into this
announcement.
Addresses for correspondence
|
|
|
|
|
|
Registered office
|
Registrar and transfer office
|
Swedish Central Securities Depository
|
US depositary
Deutsche Bank Trust Company Americas
|
|
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge
CB2 0AA
|
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
|
Euroclear Sweden AB PO Box 191
SE-101 23 Stockholm
|
American Stock Transfer
6201 15th Avenue
Brooklyn
NY 11219
|
|
United Kingdom
|
United Kingdom
|
Sweden
|
United States
|
|
|
|
|
|
|
+44 (0) 20 3749 5000
|
0800 389 1580
|
+46 (0) 8 402 9000
|
+1 (888) 697 8018
|
|
|
+44 (0) 121 415 7033
|
|
+1 (718) 921 8137
|
|
|
|
|
|
Cautionary statements regarding forward-looking
statements
In order, among other things, to utilise the 'safe harbour'
provisions of the US Private Securities Litigation Reform Act 1995,
the Group provides the following cautionary statement:
This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of
the Group, including, among other things, statements about expected
revenues, margins, earnings per share or other financial or other
measures. Although the Group believes its expectations are based on
reasonable assumptions, any forward-looking statements, by their
very nature, involve risks and uncertainties and may be influenced
by factors that could cause actual outcomes and results to be
materially different from those predicted. The Forward-looking
statements reflect knowledge and information available at the date
of preparation of this document and AstraZeneca undertakes no
obligation to update these forward-looking statements. We identify
the forward-looking statements by using the words 'anticipates',
'believes', 'expects', 'intends' and similar expressions in such
statements. Important factors that could cause actual results to
differ materially from those contained in forward-looking
statements, certain of which are beyond our control, include, among
other things:
Nothing in this document, or any related presentation/webcast,
should be construed as a profit forecast.
[11] Extensive
stage.
[12] Small cell lung
cancer.
[13] The treatment of a
cancer in the advanced, metastatic setting after 2nd-line treatment
(see below).
[14] Human epidermal
growth factor receptor 2 positive.
[15] Neurofibromatosis
type 1.
[16] Non-small cell lung
cancer.
[17] Overall
survival.
[18] The initial treatment
of a cancer in the advanced, metastatic
setting.
[19] The treatment of a
cancer in the advanced, metastatic setting after the initial
treatment.
[20] Chronic kidney
disease.
[21] Breast cancer
susceptibility genes 1/2 mutation.
[22] Type-2
diabetes.
[23] CV outcomes
trial.
[24] Heart
failure.
[25] Chronic obstructive
pulmonary disease.
[26] Cannot be removed
completely through surgery.
[27] Chronic lymphocytic
leukaemia.
[28] Coronary artery
disease.
[29] Painless, benign soft
growths inside the nose.
[30] Systemic lupus
erythematosus.
[31] HER2
immunohistochemistry 1+ or 2+ with fluorescence in situ
hybridisation test result negative.
[32] A group of disorders
in which the bone marrow fails to produce healthy blood
cells.
[33] Substitution of
threonine (T) with methionine (M) at position 790 of exon 20
mutation.
[34] Where AstraZeneca
does not retain a significant ongoing interest in medicines or
potential new medicines, income from divestments is reported within
Other Operating Income and Expense in the Company's financial
statements.
[35] As per the FY 2019
results announcement.
[36] Based on average
daily spot rates in FY 2019.
[37] Based on average
daily spot rates from 1 January 2020 to 31 March
2020.
[38] Other currencies
include AUD, BRL, CAD, KRW and RUB.
[39] These priorities were
determined through a materiality assessment conducted in 2018 with
a broad range of external and internal stakeholders, respectively.
Combined, they ensure the maximum possible benefit to patients, the
Company, broader society and the planet. AstraZeneca's
sustainability priorities align with the United Nations Sustainable
Development Goals (SDG), and, in particular, SDG three for 'Good
Health'.
[40] Phase II trial data,
with potential for registration.
[41] Subject to regulatory
approvals associated with AbbVie Inc.'s (AbbVie) proposed
acquisition of Allergan plc (Allergan).
[42] First patient
commenced dosing.
[43] Last patient
commenced dosing.
[44] Programmed
death-ligand 1, a protein that assists in the body's immune
responses.
[45] Conducted by the
Canadian Cancer Trials Group.
[46] Progression-free
survival.
[47] Bacillus
Calmette-Guerin.
[48] Hepatocellular
carcinoma (liver cancer).
[49] Transarterial
chemoembolisation.
[50] Head and neck
squamous cell carcinoma.
[51] The US Orphan Drug
Act grants special status to a medicine or potential medicine to
treat a rare disease or condition upon request of a sponsor.
Designation qualifies the sponsor of the medicine for various
development incentives.
[52] Conducted by the
ARCAGY/Groupe d'Investigateurs national des Etudes des Cancers
Ovariens et du sein.
[53] Conducted by the
National Cancer Institute (US).
[54] Immunohistochemistry.
[55] In situ
hybridisation.
[56] Quaque die, or once a day.
[57] Estimated glomerular
filtration rate.
[58] End-stage renal
disease.
[59] Bis in die, or twice a day.
[60] A specific situation
in which a medicine should not be used as a treatment as it may be
harmful to the patient.
[61] Birmingham Vasculitis
Activity Score.
[62] Hypereosinophilic
syndrome.
[63] Patient-reported
outcomes.
[64] The table provides an
analysis of year-on-year Product Sales, with Actual and CER growth
rates reflecting year-on-year growth. Due to rounding, the sum of a
number of dollar values and percentages may not agree to totals.
*Denotes a legacy medicine.
[65] The table below
provides an analysis of sequential quarterly Product Sales, with
actual and CER growth rates reflecting quarter-on-quarter growth.
Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals. *Denotes a legacy
medicine.
[66] The table below
provides an analysis of sequential quarterly Product Sales, with
actual and CER growth rates reflecting quarter-on-quarter growth.
Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals. *Denotes a legacy
medicine.
[67] Not recorded within
Core Other Operating Income and Expense.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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AstraZeneca
PLC
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Date:
29 April 2020
|
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By: /s/
Adrian Kemp
|
|
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Name:
Adrian Kemp
|
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Title:
Company Secretary
|