Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of April
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
26 April 2019 07:00 BST
Q1 2019 Results
Another strong top-line performance, with operating leverage
supporting compelling growth in earnings
Results in the first quarter were supported by Product Sales growth
of 10% (14% at CER1)
to $5,465m, a reflection of the sustained performance of new
medicines2 (+77%,
+83% at CER). Global Oncology sales increased by 54% (59% at CER),
New CVRM3 by
15% (19% at CER) and, driven by the strength
of Fasenra, Respiratory sales increased by 9% (14% at CER).
Emerging Markets sales increased by 14% (22% at CER); China sales
increased by 21% (28% at CER), with ex-China Emerging Markets also
delivering strong growth at CER. US sales increased by 20%, while
Europe sales declined by 12% (6% at CER). Japan sales increased by
26% (27% at CER) to $501m.
The Reported Operating Margin increased by seven percentage points
to 20% and the Core Operating Margin increased by 13 percentage
points to 30%. These financial results were accompanied by further
positive pipeline developments, with 2019 set to be another busy
year for news flow.
|
|
Q1 2019
|
|
|
$m
|
% change
|
|
|
Actual
|
CER
|
|
Product
Sales
|
5,465
|
10
|
14
|
|
Collaboration
Revenue4
|
26
|
(87)
|
(86)
|
|
Total
Revenue
|
5,491
|
6
|
11
|
|
|
|
|
|
|
Reported5 Operating
Profit
|
1,097
|
58
|
68
|
|
Core6 Operating
Profit
|
1,650
|
84
|
96
|
|
|
|
|
|
|
Reported
Earnings Per Share (EPS)
|
$0.47
|
75
|
90
|
|
Core
EPS
|
$0.89
|
85
|
100
|
Pascal Soriot, Chief Executive Officer, commenting on the results
said:
"Our 14% Product Sales growth in the quarter reflected the success
of our new medicines and Emerging Markets. In
Oncology,Tagrisso, Imfinzi and Lynparza continued to do well and, in
BioPharma, Farxiga, Brilinta and Fasenra also grew strongly. Emerging Markets, our
largest sales region, delivered an outstanding performance with a
22% growth rate; all of its sub-regions grew strongly, including
China at 28%.
Our Core Operating Profit almost doubled, demonstrating strong
operating-margin improvement. Together with this encouraging
financial start to the year, our highly-productive and sustainable
pipeline continued to deliver, notably with a regulatory approval
for Lynparza in the EU for the treatment of metastatic
breast cancer and approvals of Farxiga in type-1 diabetes. The recently-announced
collaboration with Daiichi Sankyo also broadened an exciting
Oncology portfolio with a potentially-transformative cancer
treatment that could benefit patients around the world. We
appreciate the support from our shareholders in realising this
exceptional opportunity."
Financial summary
-
Product Sales increased by 10% in the quarter (14% at CER) to
$5,465m
-
The Reported Gross Margin increased by two percentage points (three
at CER) to 79%, partly reflecting the mix of Product Sales; the
Core Gross Margin also increased by two percentage points to
80%
- Reported Operating
Expenses increased by 1% (5% at
CER) to $3,858m and represented 70% of Total Revenue
(Q1 2018: 74%). Core
Operating Expenses increased by
1% (5% at CER) to $3,369m and represented 61% of Total
Revenue (Q1 2018: 65%)
- Reported
R&D Expenses declined by 1% (an increase of 3% at CER) to
$1,266m. Core R&D Expenses declined by 1% (an increase of 3% at
CER) to $1,225m
- Reported SG&A Expenses
increased by 2% (7% at CER) to $2,514m; Core SG&A Expenses
increased by 2% (6% at CER) to $2,066m, reflecting ongoing
additional support for new medicines and growth in
China
-
Reported Other Operating Income and Expense increased by 26% (27%
at CER) to $593m, primarily reflecting the impact of the divestment
of US rights to Synagis; Core Other Operating Income
and Expense increased by 379% (383% at CER) to $594m
-
The Reported Operating Margin increased by seven percentage points
to 20%; the Core Operating Margin increased by 13 percentage points
to 30%
-
Reported EPS of $0.47, based on a weighted-average number of shares
of 1,267m, represented an increase of 75% (90% at CER); the
Reported Tax Rate was 26% (Q1 2018: 16%). Core EPS
increased by 85% (100% at CER) to $0.89; the Core Tax Rate was 23%
(Q1 2018: 18%). The tax rates reflected the geographical mix of
profits and the impact of divestment transactions
- On 29 March 2019, the Company initiated an equity
placing of $3.5bn in conjunction with the recent strategic
collaboration with Daiichi Sankyo Company, Limited (Daiichi
Sankyo). The purpose of the placing was to fund the initial upfront
and near-term milestone commitments arising from the collaboration,
as well to strengthen AstraZeneca's balance sheet. One of the
Company's capital-allocation priorities is to maintain a strong,
investment-grade credit rating; the share issuance struck an
appropriate balance between the Company's equity investors and
creditors
Commercial summary
Oncology
Sales
growth of 54% in the quarter (59% at CER) to $1,892m,
including:
-
Tagrisso sales of $630m, representing growth of 86%
(92% at CER) that was driven by the 2018 regulatory approvals as a
standard of care (SoC) in the 1st-line EGFR7-mutated (EGFRm)
NSCLC8 setting. There
was a sequential decline in US sales of Tagrisso reflecting inventory
and gross-to-net movements; underlying demand growth,
however, remained strong. Globally, Tagrisso became AstraZeneca's
biggest-selling medicine in the quarter
-
Imfinzi sales of $295m, representing growth of 376%
(381% at CER). The performance was a result of ongoing launches for
the treatment of patients with unresectable, Stage III NSCLC. The
majority of sales of Imfinzi were in the US, where it
is the only approved medicine following SoC chemoradiation therapy
(CRT) for the curative-intent treatment of patients with Stage III,
unresectable NSCLC
-
Lynparza sales of $237m,
representing growth of 99% (105% at CER), driven by expanded use in
the treatment of ovarian and breast cancer, including a
particularly strong launch in the US as a 1st-line ovarian cancer
treatment
- Oncology sales growth in Emerging Markets
of 35% (46% at CER) to $490m
New
CVRM
Sales
growth of 15% in the quarter (19% at CER) to $1,033m,
including:
- Farxiga sales of $349m, with growth of 17% (23% at
CER), ahead of an anticipated label update in major markets to
reflect results from the DECLARE trial
-
Brilinta sales of $348m,
representing growth of 19% (24% at CER), due to continued market
penetration in the treatment of acute coronary syndrome and
high-risk post-myocardial infarction
-
Bydureon sales of $142m,
an increase of 2% (4% at CER), despite the impact of supply-chain
constraints that are anticipated to ease later in the
year
- New CVRM sales growth in Emerging Markets
of 26% (40% at CER) to $239m
Respiratory
Sales
growth of 9% in the quarter (14% at CER) to $1,283m,
including:
-
A Symbicort sales decline of 8% (3%
at CER) to $585m. US sales, at $176m, declined by 4%, reflecting
continued pricing pressure and the impact of managed-market
rebates, partially offset by positive volumes from government
buying and a favourable gross-to-net adjustment. Emerging Markets
sales increased by 4% (13% at CER) to $133m
-
Pulmicort sales growth of 11% (16% at CER) to
$383m
-
Fasenra sales of $129m, representing growth of 514%
(524% at CER). In the US, new-to-brand prescription data showed
that Fasenra was
the preferred novel-biologic medicine for the treatment of severe
asthma during the period, despite being the third medicine to enter
the market
- Respiratory sales
growth in Emerging Markets of 18% (26% at CER) to $518m, driven by
the aforementioned sales growth of Pulmicort
Emerging
Markets
The
Company's largest region by Product Sales, with growth of 14% in
the quarter (22% at CER) to $2,004m, including:
- A China sales increase of 21% (28% at CER) to
$1,242m. Highlights included Oncology sales growth of 43% (51% at
CER) to $284m and Respiratory growth of 25% (31% at CER) to
$400m
- An ex-China sales increase of 3% (13% at
CER) to $762m; every Emerging Market sub-region delivered strong
growth at CER. Notable performances included sales of $281m in
(non-China) Asia-Pacific (+5%, +9% at CER) and $49m in Russia
(+44%, +68% at CER)
Pipeline highlights
The following table highlights significant developments in the
late-stage pipeline since the prior results
announcement:
|
Regulatory
approvals
|
- Lynparza -
breast cancer (BRCAm9): regulatory
approval (EU)
- Forxiga -
T1D10:
regulatory approval (EU, JP)
- Duaklir -
COPD11:
regulatory approval (US) (by partner)
|
|
Regulatory
submissions and/or acceptances
|
- Lynparza -
breast cancer (BRCAm):
regulatory submission (CN)
- Farxiga -
T2D12 (CVOT13):
regulatory submission acceptance (US, EU)
- PT010
- COPD: regulatory submission acceptance (US, EU)
|
|
Major
Phase III data readouts or other significant
developments
|
- Lynparza -
pancreatic cancer (BRCAm):
met primary endpoint
- selumetinib
- NF114:
Breakthrough Therapy Designation (US)
- Brilinta - CAD15 /
T2D (CVOT): met primary endpoint
- saracatinib
- IPF16:
Orphan Drug Designation (US)
|
FY 2019 guidance reiterated
The Company today reiterates its FY 2019 guidance. All measures in
this section are at CER and Company guidance is on Product Sales
and Core EPS only. All guidance and indications provided assume
that the UK's anticipated exit from the European Union (EU), even
in the event of a no-deal exit, proceeds in an orderly manner such
that the impact is within the range expected, following the
Company's extensive preparations for such an
eventuality.
|
Product Sales
|
A high
single-digit percentage increase
|
In addition to the aforementioned Product Sales growth, the Company
anticipates productivity gains and operating leverage in FY 2019.
Core Operating Profit is anticipated to grow at a faster rate than
Product Sales, despite an anticipated decline in the sum of
Collaboration Revenue and Core Other Operating Income and Expense
vs. the prior year. More details are provided below.
Variations in performance between quarters can be expected to
continue. The Company is unable to provide guidance and indications
on a Reported basis because the Company cannot reliably forecast
material elements of the Reported result, including the 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.
FY 2019 indications
Outside of guidance, the Company provides its indications at CER
for FY 2019 vs. the prior year:
- The Company anticipates strong and sustainable
Product Sales growth to be accompanied by operating leverage,
leading to an improvement in profitability. In FY 2019, the cash
performance is expected to be adversely impacted by a number of
one-off payments relating to prior business-development
transactions; a significant proportion of these payments was made
in Q1 2019
- As part of its long-term growth strategy,
the Company remains committed to focusing on appropriate
cash-generating and value-accretive collaboration and divestment
transactions that reflect the ongoing productivity of the pipeline
and the Company's increasing focus on its main therapy areas. The
sum of Collaboration Revenue and Core Other Operating Income and
Expense, however, is anticipated to decline vs. the prior
year
- Core Operating Expenses are expected to
increase by a low single-digit percentage. Specific support for
medicine launches and AstraZeneca in China historically has
delivered compelling results and elements of that support will
continue. The Company will retain flexibility in its investment
approach
- Core Operating Profit is anticipated to
increase, ahead of Product Sales, by a mid-teens percentage vs. FY
2018
- Capital expenditure is expected to be
broadly stable and restructuring expenses are targeted to reduce
vs. the prior year
- A Core Tax Rate of 18-22% (FY 2018:
11%)
Currency impact
If foreign-exchange rates were to remain at the average of rates
seen in the period January to March 2019, it is anticipated that
there would be a low single-digit percentage adverse impact on
Product Sales and Core EPS. In addition, the Company's
foreign-exchange rate sensitivity analysis is contained within the
operating and financial review.
Sustainability
AstraZeneca's sustainability ambition is founded on making science
accessible and operating in a way that recognises the
interconnection between the health of the business, people and the
planet and that each of these impact one another. The Company's
sustainability ambition is reinforced by its purpose and values,
which are intrinsic to its business model and ensures that the
delivery of its strategy broadens access to healthcare, minimises
the environmental footprint of its activities and products of
medicines and processes and ensures that all business activities
are underpinned by the highest levels of ethics and transparency. A
full update on the Company's sustainability progress is shown in
the Sustainability section of this announcement.
Notes
The following notes refer to pages 1-4:
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. Tagrisso, Imfinzi, Lynparza, Calquence, Farxiga, Brilinta, Lokelma, Fasenra and Bevespi. These new medicines are pillars in the main
therapy areas and are important platforms for future
growth.
3. New Cardiovascular (CV), Renal and
Metabolism, incorporating Diabetes
medicines, Brilinta and Lokelma.
4.
Formerly Externalisation Revenue. Effective from 1 January 2019,
the Company updated the presentation of this element of Total
Revenue within the Statement of Comprehensive Income; see Note
1.
5.
Reported financial measures are the financial results presented in
accordance with International Financial Reporting Standards, as
adopted by the EU and as issued by the International Accounting
Standards Board.
6.
Core financial measures. These are non-GAAP financial measures
because, unlike Reported performance, they cannot be derived
directly from the information in the Company Financial Statements.
See the operating and financial review for a definition of Core
financial measures and a reconciliation of Core to Reported
financial measures.
7.
Epidermal growth factor receptor.
8.
Non-small cell lung cancer.
9.
Breast cancer susceptibility genes 1/2, mutated.
10.
Type-1 diabetes.
11.
Chronic obstructive pulmonary disease.
12.
Type-2 diabetes.
13.
Cardiovascular outcomes trial.
14.
Neurofibromatosis type 1.
15.
Coronary artery disease.
16.
Idiopathic pulmonary fibrosis.
Pipeline: forthcoming 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.
|
Q2
2019
|
- Tagrisso -
NSCLC (1st line, EGFRm): regulatory decision (CN)
- roxadustat -
anaemia of CKD[17]:
data readout (pooled safety)
|
|
H2
2019
|
- Tagrisso -
NSCLC (1st line, EGFRm): data readout (final OS)
- Imfinzi -
unresectable, Stage III NSCLC: regulatory decision
(CN)
- Imfinzi +
treme - NSCLC (1st line) (NEPTUNE): data readout, regulatory
submission
- Imfinzi +/-
treme - NSCLC (1st line) (POSEIDON): data readout, regulatory
submission
- Imfinzi +/-
treme - small-cell lung cancer: data readout, regulatory
submission
- Imfinzi +/-
treme - bladder cancer (1st line): data readout, regulatory
submission
- Imfinzi +/-
treme - head & neck cancer (1st line): data readout, regulatory
submission
- Lynparza -
ovarian cancer (1st line, BRCAm) (SOLO-1): regulatory decision
(EU, JP, CN)
- Lynparza -
ovarian cancer (3rd line, BRCAm): regulatory submission
(US)
- Lynparza -
ovarian cancer (1st line) (PAOLA-1): data readout
- Lynparza -
pancreatic cancer (BRCAm):
regulatory submission
- Lynparza -
prostate cancer (2nd line, castration-resistant): data
readout
- trastuzumab
deruxtecan - advanced/refractory, metastatic breast cancer
(HER2[18]-positive):
data readout, regulatory submission (US)
- Calquence -
CLL[19]:
data readout, regulatory submission
- selumetinib
- NF1: regulatory submission
- Farxiga -
T1D: regulatory decision (US)
- Farxiga -
heart failure CVOT: data readout
- Brilinta -
CAD / T2D CVOT: regulatory submission
- Lokelma -
hyperkalaemia: regulatory submission (JP)
- roxadustat
- anaemia of CKD: regulatory submission (US)
- Symbicort -
mild asthma: regulatory decision (EU), regulatory submission
(CN)
- Bevespi -
COPD: regulatory decision (JP, CN)
- Fasenra -
self administration and autoinjector: regulatory decision (US,
EU)
- PT010
- COPD: regulatory decision (JP, CN)
- PT010
- COPD: data readout (ETHOS)
|
|
2020
|
- Imfinzi -
neo-adjuvant NSCLC: data readout
- Lynparza -
breast cancer (BRCAm):
regulatory decision (CN)
- Lynparza -
ovarian cancer (1st line) (PAOLA-1): regulatory
submission
- Lynparza -
prostate cancer (2nd line, castration-resistant): regulatory
submission
- trastuzumab
deruxtecan - advanced/refractory, metastatic gastric cancer
(HER2-positive): data readout
- Farxiga -
T2D CVOT: regulatory decision (US, EU)
- Farxiga -
heart failure CVOT: regulatory submission
- Brilinta -
stroke (THALES): data readout, regulatory submission
- Epanova -
hypertriglyceridaemia CVOT: data readout
- Lokelma -
hyperkalaemia: regulatory submission (CN)
- roxadustat
- anaemia of myelodysplastic syndrome: data readout
- Fasenra -
nasal polyps: data readout, regulatory submission
- PT010
- COPD: regulatory decision (US, EU)
- tezepelumab
- severe asthma: data readout
|
Conference call
A conference call and webcast for investors and analysts will begin
at 12pm UK time today. Details can be accessed via
astrazeneca.com.
Reporting calendar
The Company intends to publish its first-half and second-quarter
financial results on 25 July 2019.
About AstraZeneca
AstraZeneca 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
its main therapy areas - Oncology, CVRM and Respiratory.
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 us on Twitter @AstraZeneca.
|
Investor
Relations
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
|
Christer
Gruvris
|
BioPharma
(cardiovascular, metabolism)
|
+44 203
749 5711
|
|
Nick
Stone
|
BioPharma
(respiratory, renal)
|
+44 203
749 5716
|
|
Josie
Afolabi
|
Other
medicines
|
+44 203
749 5631
|
|
Craig
Marks
|
Finance,
fixed income
|
+44
7881 615 764
|
|
Jennifer
Kretzmann
|
Corporate
access, retail investors
|
+44 203
749 5824
|
|
US
toll-free
|
|
+1 866
381 7277
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|
Media
Relations
|
|
|
|
Gonzalo
Viña
|
|
+44 203
749 5916
|
|
Rob
Skelding
|
Oncology
|
+44 203
749 5821
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|
Rebecca
Einhorn
|
Oncology
|
+1 301 518 4122
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|
Matt
Kent
|
BioPharma
|
+44 203
749 5906
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Jennifer
Hursit
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Other
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+44
7384 799 726
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Christina Malmberg
Hägerstrand
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Sweden
|
+46 8
552 53 106
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Michele
Meixell
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US
|
+1 302
885 2677
|
Operating and financial review
All
narrative on growth and results in this section is based on actual
exchange rates, unless stated otherwise. Financial figures are in
US$ millions ($m). The performance shown in this announcement
covers the three-month period to 31 March 2019 (the quarter or Q1
2019) compared to the three-month period to 31 March 2018 (Q1 2018)
respectively, unless stated otherwise. All commentary in the
operating and financial review relates to the quarter, 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 Company Condensed
Consolidated Financial Statements. Management believes that these
non-GAAP financial measures, when provided in combination with
Reported results, will provide investors and analysts with helpful
supplementary information to understand better the financial
performance and position of the Company on a comparable basis from
period to period. These non-GAAP financial measures are not a
substitute for, or superior to, financial measures prepared in
accordance with GAAP. Core financial measures are adjusted to
exclude certain significant items, such as:
- Amortisation and impairment of intangible assets,
including impairment reversals but excluding any charges relating
to IT assets
- Charges and provisions related to
restructuring programmes, which includes charges that relate to the
impact of restructuring programmes on capitalised IT
assets
- Other specified items, principally
comprising acquisition-related costs, which include fair-value
adjustments and the imputed finance charge relating to contingent
consideration on business combinations and legal
settlements
Details on the nature of Core financial measures are provided on
page 76 of the Annual
Report and
Form 20-F Information 2018. Reference should be made to the
reconciliation of Core to Reported financial information and the
Reconciliation of Reported to Core financial measures table
included in the financial performance section of this
announcement.
EBITDA is defined as Reported Profit Before Tax after adding back
Net Finance Expense, results from Joint Ventures and Associates and
charges for Depreciation, Amortisation and Impairment. Reference
should be made to the Reconciliation of Reported Profit Before Tax
to EBITDA included in the Financial Performance section of this
announcement.
Net Debt is defined as interest-bearing loans and borrowings 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
section of this announcement. Ongoing Collaboration Revenue is
defined as Collaboration Revenue excluding Initial Collaboration
Revenue (which is defined as Collaboration Revenue that is
recognised at the date of completion of an agreement or
transaction, in respect of upfront consideration). Ongoing
Collaboration Revenue comprises, among other items, royalties,
milestone revenue and profit-sharing income. Reference should be
made to the Collaboration Revenue table in this operating and
financial review.
The Company strongly encourages investors and analysts not to rely
on any single financial measure, but to review AstraZeneca's
financial statements, including the notes thereto and other
available Company reports, carefully and in their
entirety.
Due to rounding, the sum of a number of percentages may not agree
to totals.
Table 1: Total Revenue
|
|
Q1 2019
|
|
$m
|
% change
|
|
Actual
|
CER
|
|
Product
Sales
|
5,465
|
10
|
14
|
|
Collaboration
Revenue
|
26
|
(87)
|
(86)
|
|
|
|
|
|
|
Total Revenue
|
5,491
|
6
|
11
|
Table 2: Product Sales
|
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
CER
|
|
Oncology
|
1,892
|
35
|
54
|
59
|
|
New
CVRM
|
1,033
|
19
|
15
|
19
|
|
Respiratory
|
1,283
|
23
|
9
|
14
|
|
Other
medicines
|
1,257
|
23
|
(25)
|
(21)
|
|
|
|
|
|
|
|
Total Product Sales
|
5,465
|
100
|
10
|
14
|
Table 3: Top-ten medicines
The top-ten medicines in the quarter by Product Sales are shown in
the table below:
|
Medicine
|
Therapy Area
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
CER
|
|
Tagrisso
|
Oncology
|
630
|
12
|
86
|
92
|
|
Symbicort
|
Respiratory
|
585
|
11
|
(8)
|
(3)
|
|
Pulmicort
|
Respiratory
|
383
|
7
|
11
|
16
|
|
Nexium
|
Other medicines
|
363
|
7
|
(19)
|
(16)
|
|
Farxiga
|
CVRM
|
349
|
6
|
17
|
23
|
|
Brilinta
|
CVRM
|
348
|
6
|
19
|
24
|
|
Crestor
|
CVRM
|
335
|
6
|
(14)
|
(9)
|
|
Imfinzi
|
Oncology
|
295
|
5
|
n/m
|
n/m
|
|
Faslodex
|
Oncology
|
254
|
5
|
-
|
4
|
|
Lynparza
|
Oncology
|
237
|
4
|
99
|
n/m
|
|
|
|
|
|
|
|
|
Total
|
|
3,779
|
69
|
19
|
24
|
Table 4: Collaboration Revenue
Ongoing Collaboration Revenue of $26m represented all Collaboration
Revenue in the quarter (Q1 2018: $91m, 47%). A breakdown of
Collaboration Revenue is shown below:
|
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
CER
|
|
Initial Collaboration Revenue
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
Royalties
|
17
|
65
|
n/m
|
n/m
|
|
Milestones/Other[20]
|
9
|
35
|
(89)
|
(89)
|
|
Ongoing Collaboration Revenue
|
26
|
100
|
(72)
|
(71)
|
|
|
|
|
|
|
|
Total Collaboration Revenue
|
26
|
100
|
(87)
|
(86)
|
Product Sales
The
performance of new and legacy medicines is shown below, with a
geographical split shown in Note 7.
Table 5: Therapy area and medicine performance
|
Therapy Area
|
Medicine
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
CER
|
|
Oncology
|
Tagrisso
|
630
|
12
|
86
|
92
|
|
Imfinzi
|
295
|
5
|
n/m
|
n/m
|
|
Lynparza
|
237
|
4
|
99
|
n/m
|
|
Iressa
|
134
|
2
|
2
|
7
|
|
Calquence
|
29
|
1
|
n/m
|
n/m
|
|
Legacy:
|
|
|
|
|
|
Faslodex
|
254
|
5
|
-
|
4
|
|
Zoladex
|
194
|
4
|
5
|
13
|
|
Arimidex
|
51
|
1
|
(6)
|
-
|
|
Casodex
|
48
|
1
|
(8)
|
(4)
|
|
Others
|
20
|
-
|
(26)
|
(22)
|
|
Total Oncology
|
1,892
|
35
|
54
|
59
|
|
BioPharma - CVRM
|
Farxiga
|
349
|
6
|
17
|
23
|
|
Brilinta
|
348
|
6
|
19
|
24
|
|
Onglyza
|
153
|
3
|
19
|
23
|
|
Bydureon
|
142
|
3
|
2
|
4
|
|
Byetta
|
30
|
1
|
(3)
|
-
|
|
Symlin
|
7
|
-
|
(22)
|
(22)
|
|
Legacy:
|
|
|
|
|
|
Crestor
|
335
|
6
|
(14)
|
(9)
|
|
Seloken/Toprol-XL
|
225
|
4
|
13
|
21
|
|
Atacand
|
50
|
1
|
(30)
|
(24)
|
|
Others
|
75
|
1
|
(12)
|
(6)
|
|
Total BioPharma
- CVRM
|
1,714
|
31
|
4
|
9
|
|
BioPharma -Respiratory
|
Symbicort
|
585
|
11
|
(8)
|
(3)
|
|
Pulmicort
|
383
|
7
|
11
|
16
|
|
Fasenra
|
129
|
2
|
n/m
|
n/m
|
|
Daliresp/Daxas
|
48
|
1
|
26
|
29
|
|
Tudorza/Eklira
|
20
|
-
|
(29)
|
(25)
|
|
Duaklir
|
20
|
-
|
(29)
|
(25)
|
|
Bevespi
|
10
|
-
|
n/m
|
n/m
|
|
Others
|
88
|
2
|
9
|
15
|
|
Total BioPharma
- Respiratory
|
1,283
|
23
|
9
|
14
|
|
Othermedicines
|
Nexium
|
363
|
7
|
(19)
|
(16)
|
|
Losec/Prilosec
|
76
|
1
|
10
|
16
|
|
Synagis
|
53
|
1
|
(76)
|
(76)
|
|
Seroquel XR/IR
|
37
|
1
|
(61)
|
(59)
|
|
Movantik/Moventig
|
25
|
-
|
(11)
|
(11)
|
|
Others
|
22
|
-
|
(66)
|
(66)
|
|
Total other medicines
|
576
|
11
|
(38)
|
(36)
|
|
|
Total Product Sales
|
5,465
|
100
|
10
|
14
|
Specialty-care medicines comprise all Oncology medicines
and Fasenra. At 37% of Product Sales (Q1 2018: 25%),
specialty-care medicine sales increased by 62% in the quarter (67%
at CER) to $2,021m.
Product Sales summary
Oncology
Product
Sales of $1,892m; an increase of 54% (59% at CER). Oncology Product
Sales represented 35% of total Product Sales, up from 25% in Q1
2018.
Oncology: lung cancer
Tagrisso
Tagrisso has been approved and launched in over 80
countries, including the US, in Europe, Japan and China for the
2nd-line treatment of patients with EGFR T790M[21]-mutated
NSCLC. By the end of the quarter, Tagrisso had been approved in over 65 countries
including the US, in Europe and Japan for the 1st-line treatment of
patients with EGFRm NSCLC; a number of additional regulatory
reviews are also underway.
Product Sales of $630m represented growth of 86%
(92% at CER), partly driven by regulatory approvals in the 1st-line
setting. Continued growth was also delivered in the 2nd-line
indication in other countries, including in Europe and Emerging
Markets. Tagrisso became AstraZeneca's largest selling
medicine in the quarter.
Sales
in the US increased by 76% to $259m. Tagrisso was established last year
as the SoC in the 1st-line setting with a very high penetration
rate, following the April 2018 regulatory approval. Underlying
demand growth remained strong in the quarter, despite adverse
inventory and gross-to-net movements. Within Emerging
Markets, Tagrisso sales increased by 94%
(108% at CER) to $138m, with notable growth in China,
where the medicine was added to the National Reimbursement
Drug List (NRDL) with effect from January 2019. The Asia-Pacific
region has a relatively high prevalence of lung-cancer patients
with an EGFR mutation; at c.30-40% of the total, this contrasts
with c.10-15% in the Western Hemisphere.
In
Europe, sales of $100m represented an increase of 45% (55% at CER),
driven by further growth in testing rates, positive reimbursement
decisions and strong levels of demand in the 2nd-line setting;
additional decisions are expected in 2019. Sales
of Tagrisso in
Japan increased by 151% (153% at CER) to $123m, reflecting
increasing use as a 1st-line treatment, following the 2018
regulatory approval in this setting where Tagrisso reached a very high
penetration rate. Focused activities to maximise testing and
utilisation rates in the 2nd-line setting also supported the
performance.
Imfinzi
Imfinzi is approved in c.45 countries, including the
US, in Europe and Japan for the treatment of patients with
unresectable, Stage III NSCLC whose disease has not progressed
following platinum-based CRT. It is also approved for the 2nd-line
treatment of patients with locally-advanced or metastatic
urothelial carcinoma (bladder cancer) in eight countries, including
the US.
Global Product Sales of Imfinzi increased by 376% (381% at CER) to $295m,
of which $231m were in the US, almost entirely for the treatment of
unresectable, Stage III NSCLC. Sales of $34m in Japan reflected strong demand, supported by
higher CRT and treatment rates. Sales in Europe of $23m followed recent
regulatory approvals and launches; additional approvals are
expected in due course.
Iressa
Product
Sales of $134m; a growth of 2% (7% at CER).
Emerging Markets sales increased by 21% (28% at
CER) to $86m; Iressa entered the NRDL in China in 2017 and was
included in the China '4+7' pilot tender scheme in 2018. Given the
growing use of Tagrisso, sales of Iressa declined by 50% to $4m in the US and by 13%
(7% at CER) to $26m in Europe. Japan sales amounted to $16m,
reflecting a decline of 20%.
Oncology: Lynparza
By the end of the
quarter, Lynparza was
approved in over 60 countries for the treatment of ovarian cancer.
Launches in the treatment of breast cancer took place in the US and
Japan in 2018 and regulatory approval was received in the EU in
April 2019. Lynparza has now been approved in nearly 40 countries
for the treatment of breast cancer.
Product Sales of Lynparza amounted to $237m, an increase of 99% (105%
at CER). The strong performance was geographically spread, with
launches continuing in Emerging Markets and the Established Rest of
World region (RoW). Ongoing MSD[22] co-promotion
efforts also contributed to sales.
US sales increased by 80% to $119m, driven by the
launch in the 1st-line BRCAm ovarian cancer indication at the end of 2018 and
increased demand that reflected continued growth in the treatment
with Lynparza of patients suffering from ovarian or breast
cancer. Lynparza remained the leading US medicine in the poly
ADP ribose polymerase (PARP)-inhibitor class, as measured by total
prescription volumes and in both ovarian and breast
cancer.
Sales in Europe increased by 55% (62% at CER) to $65m, driven by
increasing levels of reimbursement and BRCA-testing rates; sales also benefitted from
clinical-trial supply. The Company recently rolled out a number of
launches in a broad, 2nd-line, maintenance ovarian-cancer
indication, regardless of BRCA status. In 2018, the Company announced that
the European Medicines Agency (EMA) had approved the use
of Lynparza tablets (300mg twice daily) as a
treatment for the same patient population.
Following the initial launch in April 2018, Japan sales
of Lynparza, as a treatment for 2nd-line maintenance ovarian
cancer andBRCAm breast cancer, amounted to $22m. Emerging
Markets sales of $26m 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), resulting in the subsequent launch
of Lynparza in China, the first PARP inhibitor to be
approved in the country.
Oncology: haematology and other Oncology medicines
Calquence
Product Sales of $29m; an increase of 263%.
Calquence was approved and launched in the US in
October 2017. The medicine delivered a promising performance in the
quarter, with c.40% of new patients now treated in the 2nd-line
setting with Calquence in the approved indication of mantle cell
lymphoma (MCL). At the end of 2018, the first regulatory approvals
outside the US for the treatment of patients with MCL were granted
in Brazil and the UAE.
Legacy: Faslodex
Product
Sales of $254m; a stable performance (4% growth at
CER).
Emerging Markets sales of Faslodex increased by 15% (28% at CER) to $45m. US
sales declined by 6% to $126m; a generic Faslodex medicine did not launch in the quarter.
Europe sales declined by 8% (2% at CER) to $54m, reflecting the
continued impact of generic entrants in certain countries. In
Japan, sales increased by 33% to $28m.
Legacy: Zoladex
Product
Sales of $194m; an increase of 5% (13% at CER).
Emerging Markets sales of Zoladex increased by 13% (23% at CER) to $114m.
Sales in Europe increased by 3% (9% at CER) to $35m. In the
Established RoW region, sales declined by 10% (8% at CER) to $43m,
driven by the effects of increased competition.
BioPharma - CVRM
Total CVRM sales, which include Crestor and other legacy medicines, increased by 4%
(9% at CER) to $1,714m. Total CVRM sales represented 31% of total
Product Sales. New CVRM sales increased by 15% (19% at CER) to
$1,033m, reflecting strong performances
from Farxiga and Brilinta.
CVRM: Diabetes
Farxiga
Product
Sales of $349m; an increase of 17% (23% at CER).
Emerging Markets sales of Forxiga increased by 38% (51% at CER) to $95m,
reflecting ongoing launches, improved levels of patient access and
strong performances in key markets, such as Brazil. US sales
increased by 3% to $131m, impacted by changes in formulary access
for competitor medicines. Sales in Europe increased by 20% (30% at
CER) to $89m. In Japan, sales to the collaborator, Ono
Pharmaceutical Co., Ltd, which records in-market sales in Japan,
increased by 55% to $17m.
Onglyza
Product Sales of $153m, an increase of 19% (23% at CER) was partly
driven by favourable prior year gross-to-net adjustments in the US,
where sales increased by 59% to $78m.
Sales in Emerging Markets increased by 8% (23% at CER) to $43m,
driven by the performance in China. Sales in Europe declined by 17%
to $19m, highlighting the broader trend of a shift away from the
dipeptidyl peptidase-4 inhibitor class. Given the significant
future potential of Farxiga, the Company continues to prioritise commercial
support over Onglyza.
Bydureon
Product Sales of $142m; an increase of 2% (4% at CER).
Sales were adversely impacted by ongoing supply constraints related
to Bydureon
BCise; these are anticipated to
ease later in the year. Sales in the US increased by 5% to
$117m. Favourable sales volumes were driven by continued
growth in the glucagon-like peptide-1 class, at the expense of
insulin, for more-advanced T2D
patients. Bydureon sales in Europe declined by 22% (17% at CER)
to $18m.
Other CVRM medicines
Brilinta
Product Sales of $348m; an increase of 19% (24% at
CER).
Emerging Markets sales of Brilinta increased by 28% (38% at CER) to $97m,
bolstered by the entry onto the NRDL in China in 2017. US sales
of Brilinta, at $153m, represented an increase of 33%. The
performance was 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 declined by 3% in the quarter
(growth of 3% at CER) to $83m; volume demand grew in the
quarter.
Lokelma
Lokelma was approved in
the US and EU in 2018 for the treatment of hyperkalaemia, a serious
condition characterised by elevated potassium levels in the blood
associated with CV, renal and metabolic
diseases. Lokelma's launch programme began in the Nordics in 2018
and further launches are anticipated to commence in major markets
in due course, including the US in H2 2019.
Legacy: Crestor
Product
Sales of $335m; a decline of 14% (9% at CER).
Sales in China declined by 6% (stable at CER) to $137m, partly a
result of Crestor being unsuccessful in the '4+7' pilot tender
scheme. US sales declined by 43% to $26m, underlining the
ongoing impact of generic Crestor medicines. In Europe, sales declined by 40%
(37% at CER) to $39m, reflecting a similar impact that began in
2017. In Japan, where AstraZeneca collaborates with Shionogi
Co. Ltd, sales increased by 23% to $32m. This followed a period of
decline resulting from the entry of multiple
generic Crestor medicines in the market at the end of
2017.
BioPharma - Respiratory
Product Sales of $1,283m; an increase of 9% (14% at CER).
Respiratory Product Sales represented 23% of total Product
Sales.
Symbicort
Product
Sales of $585m; a decline of 8% (3% at CER).
Symbicort continued to
lead the global market by volume within the inhaled corticosteroid
(ICS) / long-acting beta agonist (LABA) class. Emerging Markets
sales of Symbicort increased by 4% (13% at CER) to $133m. In
contrast, US sales declined by 4% to $176m, reflecting continued
pricing pressure and the impact of managed-market rebates. This was
partially offset by positive volumes from government buying and a
favourable gross-to-net adjustment.
In Europe, sales declined by 14% (8% at CER) to $182m; the
performance partly reflected the level of price competition from
other branded and Symbicort-analogue medicines, plus government pricing
interventions. Symbicort, however, continued to retain its
class-leadership position and stabilised its volume market share in
the class, with volume growth achieved in a number of
markets.
In Japan, sales declined by 20% (18% at CER) to $40m following
destocking by Astellas Pharma Co. Ltd (Astellas). In January 2019,
AstraZeneca and Astellas announced that the sale and distribution
of Symbicort, conducted by Astellas in Japan, was to be
transferred back to AstraZeneca and that the co-promotion conducted
by Astellas and AstraZeneca will be terminated on 30 July 2019. The
Company will solely distribute and promote the medicine in Japan
from 31 July 2019. In addition, during the period, the first
generic Symbicort medicine received regulatory approval and
multiple generic Symbicort medicines are anticipated to enter the
Japanese market in due course.
Pulmicort
Product
Sales of $383m; an increase of 11% (16% at CER).
Emerging Markets, where sales increased by 16%
(23% at CER) to $314m, represented 82% of global sales
of Pulmicort. China, making up the overwhelming majority
of Pulmicort sales in Emerging Markets, delivered a
particularly strong double-digit performance, supported by higher
demand and strong underlying volume growth, underpinned by the
impact of AstraZeneca's investment in over 17,000 nebulisation
centres.
Sales
in the US and Europe declined by 17% to $24m and by 7% (4% at CER)
to $25m, respectively, a consequence of the medicine's legacy
status.
Fasenra
Product
Sales of $129m, an increase of 514% (524% at CER).
In November 2017, the Company was granted
regulatory approval for Fasenra in the US as a treatment of patients with
severe, eosinophilic asthma; the approval was followed immediately
by the launch of the medicine and US sales amounted to $93m in the
quarter. New-to-brand prescription data showed
that Fasenra was the preferred novel-biologic medicine
for the treatment of severe asthma during the period, despite being
the third medicine to enter the market.
In Europe and Japan, AstraZeneca was granted
regulatory approval in January 2018 on a similar basis to that in
the US. In Europe, sales totalled $18m in the quarter,
predominantly reflecting strong sales in Germany. Sales in Japan
amounted to $16m, following its launch in the second quarter of
2018. In addition, Fasenra led the novel asthma biologic-medicine class
by new patient share in Germany and Japan during the
period.
Daliresp/Daxas
Product
Sales of $48m; an increase of 26% (29% at CER).
US
sales, representing 85% of the global total, increased by 41% to
$41m, driven by favourable affordability-programme changes and
inventory movements. It is the only oral, selective, long-acting
inhibitor of phosphodiesterase-4, an inflammatory enzyme associated
with COPD.
Duaklir
Product
Sales of $20m; a decline of 29% (25% at CER).
Duaklir,
the Company's first inhaled dual bronchodilator medicine, is now
available for patients in over 25 countries, with almost all sales
emanating from Europe. The global LAMA/LABA class continued to grow
in the period, albeit below expectations.
Bevespi
Product Sales increased by 100% to $10m.
Bevespi saw prescriptions in the period track
in line with other LAMA/LABA launches; the class in the US,
however, continued to grow more slowly than anticipated
previously. Bevespi was the first medicine launched using the
Company's proprietaryAerosphere Delivery Technology.
Other medicines (outside the main therapy
areas)
Product Sales of $576m in the quarter; a decline of 38% (36% at
CER), partly reflecting the aforementioned divestment of US rights
to Synagis, as well as rights to Seroquel in a number of markets. Other Product Sales
represented 11% of total Product Sales, down from
19% in Q1 2018.
Nexium
Product
Sales of $363m; a decline of 19% (16% at CER).
Emerging Markets sales increased by 4% (12% at
CER) to $190m. In Europe, sales declined by 74% to $16m. In October
2018, AstraZeneca announced that it had agreed to divest the
prescription medicine rights to Nexium in Europe to Grünenthal GmbH. Sales in
the US declined by 34% to $66m and in Japan, where AstraZeneca
collaborates with Daiichi Sankyo, sales declined by 16% (15% at
CER) to $75m.
Regional Product Sales
Table 6: Regional Product Sales
|
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
CER
|
|
Emerging Markets[23]
|
2,004
|
37
|
14
|
22
|
|
|
China
|
1,242
|
23
|
21
|
28
|
|
|
Ex-China
|
762
|
14
|
3
|
13
|
|
|
|
|
|
|
|
US
|
1,786
|
33
|
20
|
20
|
|
|
|
|
|
|
|
Europe
|
982
|
18
|
(12)
|
(6)
|
|
|
|
|
|
|
|
Established
RoW
|
693
|
13
|
13
|
16
|
|
|
Japan
|
501
|
9
|
26
|
27
|
|
|
Canada
|
114
|
2
|
(10)
|
(5)
|
|
|
Other Established RoW
|
78
|
1
|
(10)
|
(2)
|
|
|
|
|
|
|
|
TOTAL
|
5,465
|
100
|
10
|
14
|
Table 7: Regional Product Sales, Emerging Markets
Product Sales of $2,004m in the quarter, an increase of 14% (22% at
CER), continuing the strong double-digit growth seen in prior
periods. New medicines represented 18% of Emerging Markets sales
(Q1 2018: 13%). Ex-China Emerging Market sales increased by 3%
(13% at CER) to $762m; every Emerging Market sub-region delivered
strong growth at CER. Notable performances included sales of $281m
in (non-China) Asia-Pacific (+5%, +9% at CER) and $49m in Russia
(+44%, +68% at CER).
|
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
CER
|
|
Oncology
|
490
|
24
|
35
|
46
|
|
|
BioPharma -
CVRM
|
747
|
37
|
7
|
16
|
|
|
BioPharma -
Respiratory
|
518
|
26
|
18
|
26
|
|
|
Other
medicines
|
249
|
12
|
(6)
|
(6)
|
|
|
|
|
|
|
|
Total
|
2,004
|
100
|
14
|
22
|
China sales, comprising 62% of total Emerging Markets sales,
increased by 21% (28% at CER) to $1,242m. New medicines delivered
particularly encouraging sales growth, supported by strong
performances from Pulmicort, Seloken, Crestor, Nexiumand Symbicort. New medicines represented 13% of China sales (Q1
2018: 9%).
Table 8: Regional Product Sales, US
Product Sales of $1,786m; an increase of 20%. New medicines
represented 57% of US Product Sales, up from 37% in Q1 2018. The
performance reflected, in particular, the success of the new
Oncology medicines, including Tagrisso, Imfinzi and Lynparza, plus the strong performance
of Fasenra in Respiratory.
|
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
|
Oncology
|
770
|
43
|
81
|
|
|
BioPharma -
CVRM
|
558
|
31
|
12
|
|
|
BioPharma -
Respiratory
|
346
|
19
|
28
|
|
|
Other
medicines
|
112
|
6
|
(62)
|
|
|
|
|
|
|
Total
|
1,786
|
100
|
20
|
Table 9: Regional Product Sales, Europe
Product Sales of $982m; a decline of 12% (6% at
CER). This partly reflected adverse continued pricing pressures and
the impact of the aforementioned divestment of the prescription
medicine rights to Nexium. Declining sales of Crestor were a result of the 2017 market entry
of Crestor generic medicines, while sales
of Synagis declined by 69% to $28m due to buying
patterns in 2019. Excluding these impacts, the sales performance
was encouraging, with new medicines delivering a promising
performance in the quarter, representing 38% of Europe Product
Sales, up from 24% in Q1 2018.
|
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
CER
|
|
Oncology
|
314
|
32
|
26
|
34
|
|
|
BioPharma -
CVRM
|
283
|
29
|
(13)
|
(8)
|
|
|
BioPharma -
Respiratory
|
285
|
29
|
(13)
|
(7)
|
|
|
Other
medicines
|
100
|
10
|
(55)
|
(49)
|
|
|
|
|
|
|
|
Total
|
982
|
100
|
(12)
|
(6)
|
Table 10: Regional Product Sales, Established RoW
Product Sales of $693m; an increase of 13% (16% at
CER). New medicines represented 38% of Established RoW sales, up
from 16% in Q1 2018. The performance during the quarter reflected,
in particular, the successes of Tagrisso, Imfinzi and Forxiga.
|
|
Q1 2019
|
|
$m
|
% of total
|
% change
|
|
Actual
|
CER
|
|
Oncology
|
318
|
46
|
66
|
67
|
|
|
BioPharma -
CVRM
|
126
|
18
|
2
|
5
|
|
|
BioPharma -
Respiratory
|
134
|
19
|
(8)
|
(5)
|
|
|
Other
medicines
|
115
|
17
|
(23)
|
(18)
|
|
|
|
|
|
|
|
Total
|
693
|
100
|
13
|
16
|
Japan sales, comprising 72% of total Established
RoW, increased by 26% (27% at CER) to $501m. Despite the entry of
generic Crestor medicines in 2018, Crestor sales in Japan increased by 23% to $32m and
represented 6% of Japan sales. New medicines represented 42% of
Japan sales, up from 15% in FY 2018, particularly reflecting the
strong performance of Tagrisso as a 1st-line treatment for patients with
EGFRm NSCLC, following regulatory approval in this setting in the
third quarter 2018.
Financial performance
Table 11: Q1 2019 Reported Profit and Loss
|
|
Reported
|
|
Q1 2019
|
Q1 2018
|
% change
|
|
$m
|
$m
|
Actual
|
CER
|
|
Product
Sales
|
5,465
|
4,985
|
10
|
14
|
|
Collaboration
Revenue
|
26
|
193
|
(87)
|
(86)
|
|
Total
Revenue
|
5,491
|
5,178
|
6
|
11
|
|
|
|
|
|
|
|
Cost of
Sales
|
(1,129)
|
(1,134)
|
-
|
-
|
|
|
|
|
|
|
|
Gross
Profit
|
4,362
|
4,044
|
8
|
13
|
|
Gross Margin[24]
|
79.3%
|
77.3%
|
+2
|
+3
|
|
|
|
|
|
|
|
Distribution
Expense
|
(78)
|
(81)
|
(4)
|
3
|
|
% Total Revenue
|
1.4%
|
1.6%
|
-
|
-
|
|
R&D
Expense
|
(1,266)
|
(1,279)
|
(1)
|
3
|
|
% Total Revenue
|
23.1%
|
24.7%
|
+2
|
+2
|
|
SG&A
Expense
|
(2,514)
|
(2,457)
|
2
|
7
|
|
% Total Revenue
|
45.8%
|
47.5%
|
+2
|
+2
|
|
Other
Operating Income & Expense
|
593
|
469
|
26
|
27
|
|
% Total Revenue
|
10.8%
|
9.1%
|
+2
|
+1
|
|
|
|
|
|
|
|
Operating
Profit
|
1,097
|
696
|
58
|
68
|
|
Operating Profit Margin
|
20.0%
|
13.4%
|
+7
|
+7
|
|
Net
Finance Expense
|
(312)
|
(308)
|
1
|
4
|
|
Joint
Ventures and Associates
|
(27)
|
(14)
|
90
|
90
|
|
Profit
Before Tax
|
758
|
374
|
n/m
|
n/m
|
|
Taxation
|
(195)
|
(58)
|
|
|
|
Tax
Rate
|
26%
|
16%
|
|
|
|
Profit
After Tax
|
563
|
316
|
78
|
95
|
|
|
|
|
|
|
|
EPS
|
$0.47
|
$0.27
|
75
|
90
|
|
|
|
|
|
|
|
Table 12: Reconciliation of Reported Profit Before Tax to
EBITDA[25]
|
|
Q1 2019 $m
|
Q1 2018 $m
|
% change
|
|
Actual
|
CER
|
|
Reported
Profit Before Tax
|
758
|
374
|
n/m
|
n/m
|
|
Net
Finance Expense
|
312
|
308
|
1
|
4
|
|
Joint
Ventures and Associates
|
27
|
14
|
90
|
90
|
|
Depreciation,
Amortisation and Impairment
|
676
|
709
|
(5)
|
-
|
|
|
|
|
|
|
|
EBITDA
|
1,773
|
1,405
|
26
|
33
|
Table 13: Q1 2019 Reconciliation of Reported to Core financial
measures
|
|
Reported
|
Restructuring
|
Intangible Asset
Amortisation & Impairments
|
Diabetes Alliance
|
Other[26]
|
Core[27]
|
Core
% change
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
|
Gross
Profit
|
4,362
|
38
|
25
|
-
|
-
|
4,425
|
7
|
13
|
|
Gross Margin
|
79.3%
|
-
|
-
|
-
|
-
|
80.5%
|
2
|
2
|
|
|
|
|
|
|
|
|
|
|
|
Distribution
Expense
|
(78)
|
-
|
-
|
-
|
-
|
(78)
|
(4)
|
3
|
|
R&D
Expense
|
(1,266)
|
34
|
7
|
-
|
-
|
(1,225)
|
(1)
|
3
|
|
SG&A
Expense
|
(2,514)
|
31
|
337
|
105
|
(25)
|
(2,066)
|
2
|
6
|
|
Other
Operating Income & Expense
|
593
|
-
|
1
|
-
|
-
|
594
|
n/m
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Profit
|
1,097
|
103
|
370
|
105
|
(25)
|
1,650
|
84
|
96
|
|
Operating Profit Margin
|
20.0%
|
-
|
-
|
-
|
-
|
30.0%
|
13
|
13
|
|
|
|
|
|
|
|
|
|
|
|
Net
Finance Expense
|
(312)
|
-
|
-
|
72
|
50
|
(190)
|
12
|
10
|
|
Taxation
|
(195)
|
(22)
|
(76)
|
(36)
|
(1)
|
(330)
|
n/m
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
EPS
|
$0.47
|
$0.06
|
$0.23
|
$0.11
|
$0.02
|
$0.89
|
85
|
100
|
Profit and loss commentary
Gross Profit
Reported Gross Profit increased by 8% in the quarter (13% at CER)
to $4,362m; Core Gross Profit increased by 7% (13% at CER) to
$4,425m, reflecting the growth in Product
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. The Reported Gross Margin increased by two percentage
points (three at CER) to 79.3%; the Core Gross Margin increased by
two percentage points to 80.5%. The increases primarily reflected
the phasing of the mix of sales.
Operating Expenses
Reported R&D Expenses declined by 1% (an
increase of 3% at CER) to $1,266m. Core R&D Expenses declined
by 1% (an increase of 3% at CER) to $1,225m and represented 22% of
Total Revenue (Q1 2018: 24%). Reported SG&A Expenses increased
by 2% (7% at CER) to $2,514m, primarily reflecting ongoing
investment focused on commercial and medical-affairs support for
launches and extensions of the Company's new medicines. These
included Lynparza, Tagrisso, Imfinzi, Calquenceand Fasenra; additional investment was also added to support
sales growth in China. Core SG&A Expenses increased by 2% (6%
at CER) to $2,066m, reflecting the aforementioned investments and
represented 38% of Total Revenue. (Q1 2018:
39%).
Other Operating Income and Expense
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. Reported Other Operating Income and Expense
increased by 26% (27% at CER) to $593m and included $515m that
reflected an agreement to
sell US rights to Synagis to Swedish Orphan Biovitrum AB
(publ).
As part of the total consideration received, $150m related to the
rights to participate in the future cashflows from the US profits
or losses for MEDI8897. This was recognised as a financial
liability and is presented in Other Payables within Non-current
Liabilities. The associated cash flow is presented within Investing
Activities. Core Other Operating Income and Expense increased by
379% (383% at CER) to $594m.
Operating Profit
Reported
Operating Profit increased by 58% in the year (68% at CER) to
$1,097m, partly driven by the increases in Product Sales, the
Reported Gross Margin and Other Operating Income and Expense. The
Reported Operating Margin increased by seven percentage points to
20.0%. Core Operating Profit increased by 84% (96% at CER) to
$1,650m; the Core Operating Margin increased by 13 percentage
points to 30.0%.
Net Finance Expense
Reported
Net Finance Expense increased by 1% (4% at CER) to $312m, partly a
result of higher Net Debt. Excluding the discount-unwind on
acquisition-related liabilities, Core Net Finance Expense increased
by 12% (10% at CER) to $190m.
Profit Before Tax
Reported
Profit Before Tax increased by 103% (122% at CER) to $758m,
reflecting the growth in Product Sales and the Reported Gross
Margin. Core Profit Before Tax increased by 102% (116% at CER) to
$1,433m, also a result of the increase in Core Other Operating
Income and Expense.
Taxation
The
Reported Tax Rate was 26% for the quarter, while the Core Tax Rate
was 23%. These tax rates were higher than the UK Corporation Tax
Rate of 19% due to the impacts of the geographical mix of profit,
as well as divestment transactions. The net cash tax paid for the
quarter was $334m (Q1 2018: $117m), representing 44% of Reported
Profit Before Tax. Increased net cash tax primarily reflected the
phasing of payments.
The
Reported and Core Tax Rates in Q1 2018 were 16% and 18%,
respectively; the net cash tax paid represented 31% of Reported
Profit Before Tax.
EPS
Reported EPS of $0.47 represented an increase of 75% (90% at CER).
Core EPS increased by 85% (100% at CER) to $0.89.
Table 14: Cash Flow
|
|
Q1 2019
|
Q1 2018
|
Change
|
|
$m
|
$m
|
$m
|
|
Reported
Operating Profit
|
1,097
|
696
|
401
|
|
Depreciation,
Amortisation and Impairment
|
676
|
709
|
(33)
|
|
|
|
|
|
|
Increase
in Working Capital and Short-Term Provisions
|
(710)
|
(993)
|
283
|
|
Gains
on Disposal of Intangible Assets
|
(512)
|
(65)
|
(447)
|
|
Non-Cash
and Other Movements
|
(396)
|
(242)
|
(154)
|
|
Interest
Paid
|
(208)
|
(128)
|
(80)
|
|
Tax
Paid
|
(334)
|
(117)
|
(217)
|
|
|
|
|
|
|
Net Cash Outflow From Operating Activities
|
(387)
|
(140)
|
(247)
|
|
|
|
|
|
|
Net Cash (Outflow)/Inflow Before Financing Activities
|
(59)
|
133
|
(192)
|
|
|
|
|
|
|
Net Cash Outflow From Financing Activities
|
(698)
|
(663)
|
(35)
|
A net cash outflow from operating activities of $387m compared to
an outflow of $140m in Q1 2018, partly a result of increased net
tax payments. The Gains on Disposal of Intangible Assets increased
to $512m (Q1 2018: $65m), reflecting the impact of the
aforementioned divestment of US rights to Synagis.
Net cash outflows before financing activities of $59m compared with
an inflow of $133m in Q1 2018. The difference partly reflected the
impact of historic business-development transactions and subsequent
payments reported within Payment of Contingent Consideration on
Business Combinations, as well as within the Purchase of Intangible
Assets. The latter included the impact of a final true-up net
payment of $413m to MSD, based on actual sales
of Nexium and Prilosec from
2014 to 2018;this was accrued over the same period. A payment from
Pfizer, Inc. of $175m was received in the quarter, recorded within
Disposal of Intangible Assets, as part of a
prior agreement to
sell the commercialisation and development rights to AstraZeneca's
late-stage small molecule antibiotics business in most markets
globally outside the US. Reflecting strong sales growth and a
pre-defined increase in royalty rates, the cash payment of
contingent consideration in respect of the Bristol-Myers Squibb
share of the global Diabetes alliance, amounted to $110m in the
quarter (Q1 2018: $62m).
Capital expenditure
Capital expenditure amounted to $174m in the quarter, compared to
$213m in Q1 2018. This included the investment in the new global
headquarters in Cambridge, UK. In November 2018, the Company
successfully completed the transition to Mace Group as construction
manager. Following a detailed review of the construction programme,
in order to optimise operational performance on site and produce a
predictable schedule to completion, overall full completion of the
building is now expected in late 2021. AstraZeneca continues to
target an initial occupation in 2020. The Company maintains its
anticipation of a broadly stable level of capital expenditure in FY
2019.
Table 15: Debt and capital structure
|
|
At 31 March 2019
|
At 31 March 2018
|
|
$m
|
$m
|
|
Cash
and Cash Equivalents
|
4,136
|
3,005
|
|
Other
Investments
|
876
|
868
|
|
|
|
|
|
Cash and Investments
|
5,012
|
3,873
|
|
|
|
|
|
Overdrafts
and Short-Term Borrowings
|
(2,044)
|
(2,776)
|
|
Leases[28]
|
(714)
|
-
|
|
Current
Instalments of Loans
|
(1,500)
|
(1,394)
|
|
Loans
Due After One Year
|
(17,320)
|
(15,684)
|
|
|
|
|
|
Interest-Bearing Loans and Borrowings
(Gross Debt)
|
(21,578)
|
(19,854)
|
|
|
|
|
|
Net
Derivatives
|
295
|
565
|
|
Net Debt
|
(16,271)
|
(15,416)
|
Capital allocation
The Board's aim is to continue to strike a balance between the
interests of the business, financial creditors and the Company's
shareholders. After providing for investment in the business,
supporting the progressive dividend policy and maintaining a
strong, investment-grade credit rating, the Board will keep under
review potential investment in immediately earnings-accretive,
value-enhancing opportunities.
Foreign exchange
The
Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign-exchange contracts against
the individual companies' reporting currency. In addition, the
Company's external dividend payments, paid principally in pounds
sterling and Swedish krona, are fully hedged from announcement to
payment date. Foreign-exchange gains and losses on forward
contracts for transactional hedging are taken to profit or
loss.
Table 16: Currency sensitivities
The Company provides the following currency-sensitivity
information:
|
|
Average ExchangeRates vs. USD
|
|
Annual Impact Of 5% Strengthening in Exchange Rate vs. USD
($m)[29]
|
|
Currency
|
Primary Relevance
|
FY 2018[30]
|
Q1 2019[31]
|
% change
|
Product Sales
|
Core Operating Profit
|
|
CNY
|
Product
Sales
|
6.62
|
6.76
|
(2)
|
221
|
126
|
|
EUR
|
Product
Sales
|
0.85
|
0.88
|
(4)
|
145
|
66
|
|
JPY
|
Product
Sales
|
110.45
|
110.07
|
-
|
114
|
74
|
|
Other[32]
|
|
|
|
|
216
|
105
|
|
|
|
|
|
|
|
|
|
GBP
|
Operating
Expenses
|
0.75
|
0.77
|
(3)
|
26
|
(72)
|
|
SEK
|
Operating
Expenses
|
8.69
|
9.16
|
(5)
|
4
|
(73)
|
Corporate and business development
a) AstraZeneca and
Daiichi Sankyo enter collaboration for novel HER2-targeting
antibody-drug conjugate
In March 2019, AstraZeneca announced
that it had entered into a global development and commercialisation
collaboration agreement with Daiichi Sankyo for trastuzumab
deruxtecan (DS-8201), a proprietary antibody-drug conjugate (ADC)
and potential new targeted medicine for cancer
treatment.
The companies will develop and commercialise trastuzumab
deruxtecan jointly
worldwide, except in Japan where Daiichi Sankyo will maintain
exclusive rights. Daiichi Sankyo will be solely responsible for
manufacturing and supply. Under the terms of the agreement,
AstraZeneca will pay Daiichi Sankyo an upfront payment of $1.35bn,
half of which was due upon execution (and settled in Q2 2019), with
the remainder payable 12 months later. Contingent payments of up to
$5.55bn comprise $3.8bn for potential successful achievement of
future regulatory and other milestones, as well as $1.75bn for
sales-related milestones. Overall, the transaction will be
accounted for as an acquisition of an intangible asset, recognised
initially at the present value of non-contingent consideration,
with future milestones capitalised into the intangible asset as
they are recognised. AstraZeneca and Daiichi Sankyo will share
equally development and commercialisation costs as well as profits
from trastuzumab deruxtecan worldwide, except for Japan, where
Daiichi Sankyo will incur all costs and AstraZeneca will receive a
royalty on sales.
Daiichi Sankyo will record sales in the US, certain countries in
Europe and certain other markets where Daiichi Sankyo has
affiliates. Gross profits and royalties shared with AstraZeneca
will be accounted for as Collaboration Revenue by the Company.
AstraZeneca is expected to record Product Sales in all other
markets worldwide for which profits shared with Daiichi Sankyo will
be accounted for within Cost of Sales.
There were no closing conditions to the agreement and the
transaction completed in March 2019. The transaction and funding
arrangements (see Note 6) did not impact the Company's financial
guidance for 2019. The upfront payment and near-term milestones
were and will be funded from the proceeds of an equity placement
(see Note 6) of approximately $3.5bn before expenses, of which more
than half was and will be used to fund this transaction and the
ongoing collaboration.
b) AstraZeneca enters new
development and commercialisation agreement
for Fasenra
In March 2019, AstraZeneca and Kyowa Hakko Kirin
Co., Ltd. (KHK) announced a new development and commercialisation
agreement for Fasenra in all indications beyond asthma and COPD in
Asia. The Company previously had rights to Fasenra in countries and regions for COPD and asthma
indications. Under the new agreement, AstraZeneca will now have
global rights to Fasenra for all current and future
indications.
Under the terms of the agreement, AstraZeneca made an upfront
payment and, in addition, KHK will receive subsequent payments for
regulatory and commercial milestones. Other financial terms are the
same as prior agreements between the companies. AstraZeneca is now
responsible for the development, sales and marketing
of Fasenra for all indications
globally.
c) Termination of
lanabecestat collaboration with Lilly
In
March 2019, alongside collaboration partner Eli Lilly and Company
(Lilly), AstraZeneca presented the results at the Alzheimer's and
Parkinson's Disease Congress of the AMARANTH and DAYBREAK-ALZ
trials for lanabecestat, an oral beta secretase-cleaving enzyme
inhibitor. The results showed no significant disease-slowing for
those patients treated with lanabecestat and supported the decision
to discontinue the AMARANTH, AMARANTH Extension and DAYBREAK-ALZ
trials. The lanabecestat collaboration with Lilly will be
terminated.
Sustainability
AstraZeneca's sustainability ambition has three priority
areas[33],
aligned with the Company's purpose and business
strategy:
- Access to healthcare
- Environmental
protection
- Ethics and
transparency
Recent developments and progress against the priorities are
reported below:
a) Access to healthcare
During the period, the Company continued its investment in
healthcare systems by expanding its Healthy Heart Africa programme
into Ghana. In March 2019, AstraZeneca signed a Memorandum of
Understanding with Ghana Health Services to bring the programme to
the country, following a key stakeholder meeting to expedite the
development and rollout of Ghana Hypertension
Guidelines.
In March 2019, The Economist Intelligence Unit (EIU) published new
research, supported by AstraZeneca as part of
the Young
Health Programme (YHP), that highlighted the
need for an increased focus on adolescents as a way to address the
growing global burden of non-communicable disease. The EIU
research, Addressing
Non-Communicable Diseases in Adolescence, assessed how ten representative
countries of different income levels are addressing the challenges
associated with non-communicable diseases (NCDs) among adolescents.
It was based on an NCD scorecard evaluating national efforts in
policy, awareness and implementation, with a focus on four risk
factors / health areas: healthy diets, nutrition and physical
exercise; alcohol and tobacco; sexual and reproductive health; and
mental health. The aim of the research was to support policy
discussion around the topic of NCD prevention, particularly as it
relates to young people.
In March 2019, the
Company launched its YHP in Mexico in partnership with Project
HOPE, civil-society organisation Yo Quiero Yo Puedo and the
National Cancer Institute. The aim is to transform the lives of
young people in four districts of Mexico City by helping young
people to change their behaviours, especially the use of tobacco,
excessive consumption of alcohol, unhealthy diet and lack of
physical activity. The programme will also address other barriers
to healthy living, such as pollution and will promote education on
sexual and reproductive health, gender equality and mental-health
issues.
b) Environmental protection
During the period, six research papers co-authored by AstraZeneca
were published on Pharmaceuticals
in the Environment, a notable example being an
article published on environmental exposure and risk predictions
resulting from patient use of medicines in
China.
In the first quarter of 2019, AstraZeneca in Gothenburg, Sweden
launched two new environmental initiatives. The Tork PaperCircle
programme, in partnership with Sodexo and the city of Mölndal,
recycles all paper hand towels used in toilets on site, giving all
employees a visible and tactile way to participate in
sustainability efforts, as well as helping protect the environment
and reduce the business's carbon footprint. The site cafeteria also
launched a new initiative measuring food carbon footprint, with all
dishes labelled based on their climate impact. By choosing dishes
with low impact, colleagues can contribute to reducing the carbon
footprint. The initiative is led by Sodexo, in cooperation with
Klimato. The results of the food's climate impact will be reported
monthly on TV screens across the site.
In the US, the Gaithersburg, MD and Wilmington, DE sites installed
campus-wide composting facilities and the donation of unused
cafeteria food to a local food bank respectively, to support
efforts in waste management and the reduction of the Company's
environmental footprint.
c) Ethics and transparency
During the period, the Company was recognised in
a new
report by the Workforce Disclosure Initiative (WDI),
which aims to drive transparency from businesses on how they manage
their workforce. 90 global companies disclosed to the 2018 WDI
survey. AstraZeneca received a score of 71% vs. a sector average of
57% and a UK average of 58% for transparency around workforce
practices including pay, conditions and
wellbeing.
In the UK
Gender Pay Report 2018, the Company provided gender-pay
information for AstraZeneca in the UK and outlined plans for
supporting women, as well as continuing to improve the diversity of
its employee base. AstraZeneca's 2018 gender-pay gap data compared
favourably with the national average in the UK - 15% vs. 18%
national average. Globally, at the close of 2018, 45% of roles in
the Company were held by women and the Board of Directors comprised
42% women.
In respect of transparency on bioethical topics such as animals in
science, human biological samples and clinical trials, a
newBioethics
Global Standard was published on the
company's website. The updated standard reflected the latest issues
in the field as determined by the AstraZeneca Bioethics Advisory
Group, a group of subject-matter experts and corporate
representatives, sponsored by the Company's Chief Medical
Officer.
During the period, new anti-bullying and
anti sexual-harassment standards
were also published and communicated to global colleagues. The new
standards set out the Company's expectations for behaviour to
ensure all colleagues feel respected, supported and safe at work
from any form of bullying and harassment, be it mental, physical or
sexual.
Other developments
During the period, the Company published its
fourth annual Sustainability
Report,
describing progress and challenges in 2018. The content of the
report was based on those sustainability issues deemed material
through comprehensive stakeholder engagement and analysis; it
included three years of data, where available.
For more details on AstraZeneca's sustainability ambition, approach
and targets, please refer to the latest Sustainability Report
2018 and Sustainability Data
Summary 2018, available
at astrazeneca.com/sustainability.
Research and development
A comprehensive data pack comprising AstraZeneca's
pipeline of medicines in human trials can be found in the
clinical-trials appendix, available on astrazeneca.com.
Highlights of developments in the Company's late-stage pipeline
since the prior results announcement are shown
below:
Table 17: Update from the late-stage pipeline
|
Regulatory
approvals
|
4
|
- Lynparza -
breast cancer (BRCAm):
regulatory approval (EU)
- Forxiga -
T1D: regulatory approval (EU, JP)
- Duaklir -
COPD: regulatory approval (US) (by partner)
|
|
Regulatory
submissions and/or acceptances
|
5
|
- Lynparza -
breast cancer (BRCAm):
regulatory submission (CN)
- Farxiga -
T2D (CVOT): regulatory submission acceptance (US, EU)
- PT010
- COPD: regulatory submission acceptance (US, EU)
|
|
Major
Phase III data readouts or other major developments
|
4
|
- Lynparza -
pancreatic cancer (BRCAm):
met primary endpoint
- selumetinib
- NF1: Breakthrough Therapy Designation (US)
- Brilinta -
CAD/T2D (CVOT): met primary endpoint
- saracatinib
- IPF: Orphan Drug Designation (US)
|
|
New
molecular
entities
and major lifecycle medicines in Phase III trials or under
regulatory review
|
13
|
Oncology
- Tagrisso -
NSCLC[34]
- Imfinzi -
multiple cancers34
- Lynparza -
multiple cancers34
- trastuzumab
deruxtecan - breast and other cancers
- Calquence -
blood cancers
- tremelimumab
- multiple cancers
- selumetinib -
NF1[35]
- savolitinib
- NSCLC
CVRM
- roxadustat
- anaemia of CKD
Respiratory
- PT010
- COPD34
- PT027
- asthma
- tezepelumab
- severe asthma
Other medicines (outside main
therapy areas)
- anifrolumab
- lupus
|
|
Total
projects in clinical pipeline
|
139
|
|
Oncology
AstraZeneca has a deep-rooted heritage in Oncology
and offers a new generation of medicines that have the potential to
transform patients' lives and the Company's future. At least six
Oncology medicines are expected to be launched between 2014 and
2020, of which Tagrisso, Imfinzi, Lynparza, Calquence and Lumoxiti are already benefitting patients. An
extensive pipeline of small-molecule and biologic medicines is in
development and the Company is committed to advancing Oncology
medicines, primarily focused on the treatment of patients with
lung, ovarian, breast and blood cancers.
At the 2019 American Association for Cancer Research (AACR) Annual
Meeting in Atlanta, several abstracts were presented from the
TATTON Phase Ib trial, testing the combination
of Tagrisso with potential new medicines savolitinib or
selumetinib in NSCLC patients who have progressed on prior EGFR
tyrosine kinase inhibitor treatment. In addition, exploratory
analyses of blood and tissue tumour mutational burden (TMB) from
the Phase III MYSTIC trial were presented at the AACR meeting.
These assessed TMB, specifically blood-based, as a potential
biomarker of survival in 1st-line use of Imfinzi with or without tremelimumab vs.
chemotherapy in metastatic NSCLC.
Oncology: lung cancer
a) Tagrisso
Tagrisso 40mg and 80mg
once-daily oral tablets have now received approval in more over 65
countries, including in the US, Japan and in the EU, for the
1st-line treatment of patients with Stage IV EGFRm NSCLC. Multiple
other similar reviews are underway, including in China, where a
decision is anticipated during the second quarter of 2019, based on
a priority review granted in December 2018. Regulatory approvals
have been achieved in over 80 countries, including the US, in the
EU, Japan and in China for the 2nd-line treatment of patients with
EGFR T790M-mutated NSCLC.
Table 18: Key Tagrisso trials in lung cancer
|
Name
|
Phase
|
Population
|
Design
|
Timelines
|
Status
|
|
ADAURA
|
III
|
Adjuvant
EGFRm NSCLC
|
Placebo
orTagrisso
|
FPCD[36] Q4
2015LPCD Q1 2019
First data anticipated 2020+[37]
|
Recruitmentongoing
|
|
LAURA
|
III
|
Locally-advanced,
unresectable EGFRm NSCLC
|
Placebo
orTagrisso
|
FPCD Q3
2018
First
data anticipated 2020+
|
Recruitmentongoing
|
|
SAVANNAH
|
II
|
EGFRm,
MET+ locally advanced or metastatic NSCLC who have progressed
on Tagrisso
|
Tagrisso + savolitinib
|
FPCD Q1
2019
First
data anticipated 2020+
|
Recruitmentinitiating
|
b) Imfinzi
Table 19: Key Imfinzi trials in lung cancer
|
Name
|
Phase
|
Population
|
Design
|
Timelines
|
Status
|
|
AEGEAN
|
III
|
Neo-adjuvant
(before surgery) NSCLC
|
SoC
chemotherapy +/- Imfinzi,
followed
by
surgery
followed by placebo orImfinzi
|
FPCD Q1
2019
First
data anticipated 2020
|
Recruitmentongoing
|
|
ADJUVANT BR.31[38]
|
III
|
Stage
Ib-IIIa NSCLC
|
Placebo
or
Imfinzi
|
FPCD Q1
2015
First
data anticipated 2020+
|
Recruitmentongoing
|
|
PACIFIC
|
III
|
Unresectable,
Stage III NSCLC
|
Concurrent CRT[39],
followed
by
placebo
or
Imfinzi
|
FPCD Q2
2014
LPCD Q2
2016
|
PFS[40] and
OS[41]primary
endpoints both met
|
|
PACIFIC-2
|
III
|
Unresectable,
Stage III NSCLC
|
Concurrent
CRT concurrent with
placebo
or
Imfinzi, followed
by
placebo or
Imfinzi
|
FPCD Q2
2018
First
data anticipated 2020+
|
Recruitmentongoing
|
|
PACIFIC-4
|
III
|
Unresectable,
Stage I-II NSCLC
|
Stereotactic
body
radiation
therapy,
followed
by
placebo or
Imfinzi
|
FPCD Q1
2019
First
data anticipated 2020+
|
Recruitmentongoing
|
|
PACIFIC-5
|
III
|
Unresectable,
Stage III NSCLC
(Asia
predominant)
|
Concurrent
or sequential CRT,
followed
by
placebo
or
Imfinzi
|
FPCD Q1
2019
First
data anticipated 2020+
|
Recruitmentongoing
|
|
ADRIATIC
|
III
|
Limited-disease
stage small cell lung cancer (SCLC)
|
Concurrent
CRT,
followed
by
placebo
or
Imfinzi or Imfinzi+ treme
|
FPCD Q4
2018
First
data anticipated 2020+
|
Recruitmentongoing
|
|
PEARL
|
III
|
Stage
IV, 1st-line NSCLC (Asia)
|
SoC
chemotherapy or Imfinzi
|
FPCD Q1
2017LPCD Q1 2019
First
data anticipated 2020
|
Recruitmentongoing
|
|
MYSTIC
|
III
|
Stage
IV, 1st-line NSCLC
|
SoC
chemotherapy or Imfinzi or
Imfinzi + treme
|
FPCD Q3
2015
LPCD Q3
2016
|
Recruitment
completed
PFS and
OS primary endpoints not met
|
|
NEPTUNE
|
III
|
Stage
IV, 1st-line NSCLC
|
SoC
chemotherapy or Imfinzi +
treme
|
FPCD Q4
2015
LPCD Q2
2017
First
data anticipated H2 2019
|
Recruitment
completed
|
|
POSEIDON
|
III
|
Stage
IV, 1st-line NSCLC
|
SoC
chemotherapy or SoC + Imfinzior SoC + Imfinzi+ treme
|
FPCD Q2
2017
LPCD Q3
2018
First
data anticipated H2 2019
|
Recruitment
completed
|
|
CASPIAN
|
III
|
Extensive-disease
stage SCLC
|
SoC
chemotherapy or SoC + Imfinzior SoC + Imfinzi+ treme
|
FPCD Q1
2017
LPCD Q2
2018
First
data anticipated H2 2019
|
Recruitment
completed
|
Imfinzi as a potential new medicine in other tumour
types
The Company continues to advance multiple monotherapy trials
of Imfinzi and combination trials
of Imfinzi with tremelimumab and other potential new
medicines in tumour types other than lung
cancer.
Imfinzi has received
regulatory approval for the 2nd-line treatment of patients with
locally-advanced or metastatic urothelial carcinoma (bladder
cancer) in the US, Canada, Brazil, Israel, India, Australia, Hong
Kong and the UAE.
Table 20: Key Imfinzi trials in tumour types other than lung
cancer
|
Name
|
Phase
|
Population
|
Design
|
Timelines
|
Status
|
|
Stage I, II & III (non-metastatic disease)
|
|
POTOMAC
|
III
|
Non-muscle
invasive bladder cancer
|
SoC BCG or SoC BCG[42] + Imfinzi
|
FPCD Q3
2018
First
data
anticipated
2020+
|
Recruitment
ongoing
|
|
NIAGARA
|
III
|
Muscle-invasive
bladder cancer
|
Neo-adjuvant
cisplatin and gemcitabine SoC chemotherapy or SoC
+ Imfinzifollowed by
adjuvant placebo orImfinzi
|
FPCD Q1
2019
First
data
anticipated
2020+
|
Recruitment
ongoing
|
|
EMERALD-1
|
III
|
Locoregional
hepatocellular carcinoma (liver cancer)
|
Transarterial
chemoembolisation (TACE) followed by placebo or TACE +Imfinzi followed byImfinzi +
bevacizumab
or
TACE
+ Imfinzi
followed
by Imfinzi
|
FPCD Q1
2019
First
data
anticipated
2020+
|
Recruitment
ongoing
|
|
EMERALD-2
|
III
|
Locoregional
hepatocellular carcinoma at high risk of recurrence after surgery
or radiofrequency ablation
|
Adjuvant Imfinzi orImfinzi +
bevacizumab
|
-
|
Initiating
|
|
CALLA
|
III
|
Locally-advanced
cervical cancer
|
CRT or
CRT +Imfinzi followed
by placebo or Imfinzi
|
FPCD Q1
2019
First
data anticipated 2020+
|
Recruitment
ongoing
|
|
Stage IV (metastatic disease)
|
|
DANUBE
|
III
|
Stage
IV, 1st-line cisplatin chemotherapy- eligible/ineligible bladder
cancer
|
SoC
chemotherapy or Imfinzi or Imfinzi+ treme
|
FPCD Q4
2015
LPCD Q1
2017
First
data
anticipated
H2 2019
|
Recruitment
completed
|
|
NILE
|
III
|
Stage
IV, 1st-line cisplatin chemotherapy- eligible bladder
cancer
|
SoC
chemotherapy or SoC + Imfinzi or SoC + Imfinzi + treme
|
FPCD Q3
2018
First
data
anticipated
2020+
|
Recruitmentongoing
|
|
KESTREL
|
III
|
Stage
IV, 1st-line HNSCC
|
SoC
or Imfinzi orImfinzi + treme
|
FPCD Q4
2015
LPCD Q1
2017
First
data
anticipated
H2 2019
|
Recruitment
completed
|
|
EAGLE
|
III
|
Stage
IV, 2nd-line HNSCC
|
SoC
or Imfinzi orImfinzi + treme
|
FPCD Q4
2015
LPCD Q3
2017
|
Recruitment
completed
OS
primary endpoints not met
|
|
HIMALAYA
|
III
|
Stage
IV, 1st-line unresectable hepatocellular carcinoma
|
Sorafenib
or Imfinzior Imfinzi + treme
|
FPCD Q4
2017
First
data
anticipated
2020+
|
Recruitment
ongoing
|
|
TOPAZ-1
|
III
|
Stage
IV, 1st-line biliary-tract cancers
|
Gemcitabine
and cisplatin SoC chemotherapy or SoC + Imfinzi
|
-
|
Initiating
|
Oncology: Lynparza (multiple
cancers)
During the period, AstraZeneca and MSD announced positive results
from the Phase III POLO trial in pancreatic cancer. The results
demonstrated a statistically-significant and clinically-meaningful
improvement in PFS with Lynparza vs. placebo; the safety and tolerability
profile of Lynparza was consistent with previous trials. POLO
was a randomised, double-blinded, placebo-controlled trial
exploring the efficacy of Lynparza tablets as 1st-line maintenance monotherapy
for patients with germline BRCAm (gBRCAm) metastatic adenocarcinoma of the pancreas
(pancreatic cancer) whose disease has not progressed on
platinum-based chemotherapy.
The Company also recently announced that the EMA had
approved Lynparza as a monotherapy for the treatment of
gBRCAm adult patients who have HER2-negative,
locally-advanced or metastatic breast cancer. Under the
aforementioned collaboration with MSD and following this new
approval, AstraZeneca received $30m as Collaboration Revenue in Q2
2019. Also during the period, the Company acknowledged the
regulatory submission acceptance in China of the supplemental New
Drug Application (sNDA) by the NMPA, seeking approval
for Lynparza monotherapy for gBRCAm, HER2-negative, locally-advanced or metastatic
breast cancer.
Table 21: Key Lynparza trials
|
Name
|
Phase
|
Population
|
Design
|
Timelines
|
Status
|
|
PROfound
|
III
|
Metastatic
castration-resistant prostate cancer, HRRm 2L+
|
SoC
(abiraterone or enzalutamide) or Lynparza
|
FPCD Q2
2017
LPCD Q4
2018
Data
anticipated H2 2019
|
Recruitment
completed
|
|
PAOLA-1[43]
|
III
|
Stage
IV, 1st-line
ovarian
cancer
|
Bevacizumab
maintenance or
bevacizumab
+
Lynparzamaintenance
|
FPCD Q2
2015
LPCD Q2
2018
First
data
anticipated
H2 2019
|
Recruitment
completed
|
|
GY004[44]
|
III
|
Recurrent
platinum-sensitive ovarian cancer
|
SoC
chemotherapy or cediranib or cediranib +Lynparza
|
FPCD Q1
2016
|
Recruitment
ongoing
|
|
GY00544
|
II/III
|
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
2020+
|
Recruitment
ongoing (Phase III component)
|
|
DuO-O
|
III
|
Stage
IV, 1st-line
ovarian
cancer
|
Chemotherapy
+
bevacizumab
or
chemotherapy
+
bevacizumab
+
Imfinzi +/-
Lynparzamaintenance
|
FPCD Q1
2019
First
data
anticipated
2020+
|
Recruitmentongoing
|
|
MEDIOLA
|
I/II
|
Advanced,
2nd-line
gBRCAm
ovarian
cancer
Stage
IV, 1st to 3rd-line
gBRCAm,
HER2-
negative
breast cancer
Stage
IV, 2nd-line SCLC
Stage
IV, 2nd-line
gastric
cancer
|
Lynparza + Imfinzi
|
FPCD Q2
2016
LPCD Q1
2019(all except one cohort)
|
Recruitmentongoing
in one expansion cohort
Initial
data from lung, breast, prostate and ovarian-cancer cohorts
presented in 2017 and 2018
|
|
LYNK-002
|
II
|
HRRm
advanced solid tumours
|
Lynparza
|
-
|
Initiating
|
|
VIOLETTE
|
II
|
Stage
IV, advanced, triple-negative breast cancer:
-HRRm[45](BRCA)
-HRRm
(non-BRCA)
-Non-HRRm
|
Lynparza
Lynparza + ATR
(AZD6738)
Lynparza + WEE1
(AZD1775)
|
FPCD Q2
2018
First
data
anticipated
2020+
|
Recruitmentongoing
|
|
PROpel
|
III
|
Stage
IV, advanced, castration-resistant prostate cancer
|
Abiraterone
or
abiraterone
+
Lynparza
|
FPCD Q4
2018
First
data
anticipated
2020+
|
Recruitment
ongoing
|
|
BAYOU
|
II
|
Stage
IV, 1st line cis-platinum chemotherapy-ineligible
urothelial
bladder
cancer
|
Imfinzi or
Imfinzi + Lynparza
|
FPCD Q1
2018First data
anticipated
2020
|
Recruitment
ongoing
|
|
DuO-LORION
|
II
|
Stage
IV, 1st-line
NSCLC
|
SoC
chemotherapy +Imfinzi,
followed by Imfinzi orImfinzi + Lynparza
maintenance
|
FPCD Q1
2019
Data
anticipated 2020+
|
Recruitment
ongoing
|
Table 22: Key trastuzumab deruxtecan trials
|
Name
|
Phase
|
Population
|
Design
|
Timelines
|
Status
|
|
DESTINY-Breast01
|
II
|
Stage
IV, HER2-positive breast cancer post trastuzumab
emtansine
|
Trastuzumab
deruxtecan
|
FPCD Q3
2017Data anticipated H2 2019
|
Breakthrough
Therapy Designation status awarded
|
|
DESTINY-Breast02
|
III
|
Stage
IV, HER2-positive breast cancer post trastuzumab
emtansine
|
SoC or
trastuzumab deruxtecan
|
FPCD Q3
2018
Data
anticipated 2020+
|
Recruitment ongoing
|
|
DESTINY-Breast03
|
III
|
Stage
IV, HER2-positive breast cancer
|
Trastuzumab
emtansine or trastuzumab deruxtecan
|
FPCD Q3
2018
Data
anticipated 2020+
|
Recruitment ongoing
|
|
DESTINY-Breast04
|
III
|
Stage
IV, HER2-low breast cancer
|
SoC or
trastuzumab deruxtecan
|
FPCD Q4
2018
Data
anticipated 2020+
|
Recruitment ongoing
|
|
DESTNY-Gastric01
|
II
|
Stage
IV, HER2-positive gastric cancer
|
SoC or
trastuzumab deruxtecan
|
FPCD Q4
2017
Data
anticipated 2020
|
Recruitment ongoing
|
Table 23: Key Calquence trials in CLL
|
Name
|
Phase
|
Population
|
Design
|
Timelines
|
Status
|
|
ACE-CL-007
ELEVATE-TN
|
III
|
Previously-untreated
CLL
|
Chlorambucil
+ obinutuzumab
or
obinutuzumab +Calquence
or Calquence
|
FPCD Q2
2015
Data
anticipated H2 2019
|
Recruitment
completed
|
|
ACE
CL-311
|
III
|
Previously-untreated
CLL
|
Fludarabine,
cyclophosphamide and rituximab orCalquence + venetoclax
+/-
obinutuzumab
|
FPCD Q2
2019
Data
anticipated 2020+
|
Recruitment
ongoing
|
|
ACE-CL-309
|
III
|
Relapsed/refractory
CLL
|
Bendamustine
or idelalisib + rituximab orCalquence
|
FPCD Q3
2016
Data
anticipated H2 2019
|
Recruitment
completed
|
|
ACE-CL-006
ELEVATE-RR
|
III
|
Relapsed/refractory
high risk CLL
|
Ibrutinib
orCalquence
|
FPCD Q2
2015
Data
anticipated 2020+
|
Recruitment
ongoing
|
During the period, AstraZeneca received regulatory approval
for Calquence in relapsed MCL in Qatar; approval was
achieved in prior periods in the US, Brazil and the
UAE.
Other Oncology medicines
Selumetinib (NF1)
During the period, the Company announced that the US FDA had
granted Breakthrough Therapy Designation status for the MEK 1/2
inhibitor and potential new medicine, selumetinib. The designation
was for the treatment of paediatric patients aged three years and
older with NF1 symptomatic and/or progressive, inoperable plexiform
neurofibromas, a rare, incurable genetic condition.
CVRM
CVRM forms one of AstraZeneca's main therapy areas and a key growth
driver for the Company. By following the science to understand more
clearly the underlying links between the heart, kidneys and
pancreas, AstraZeneca is investing in a portfolio of medicines to
protect organs and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. The Company's ambition
is to modify or halt the natural course of CVRM diseases and
potentially regenerate organs and restore function, by continuing
to deliver transformative science that improves treatment practices
and CV health for millions of patients.
a) Farxiga (diabetes)
At the American College of Cardiology's (ACC) 68th Annual
Scientific Session in New Orleans, the Company presented positive
results from a pre-specified sub-analysis of the Phase III
DECLARE-TIMI 58 trial showing that Farxiga reduced the relative risk of major adverse
cardiovascular events (MACE) by 16%, compared to placebo in
patients with T2D who had a prior heart attack (myocardial
infarction). In another pre-specified
sub-analysis, Farxiga, compared to placebo reduced the relative
risk of hospitalisation for heart failure (hHF) in patients with
T2D regardless of their ejection fraction (EF) status, a
measurement of the percentage of blood leaving the heart with each
contraction.
These pre-specified sub-analyses of DECLARE-TIMI
58 added to the positive
primary results of the trial presented in November 2018, which
showed that Farxiga significantly reduced the risk of the
composite of hHF or CV death compared to placebo, consistently
across the trial's entire patient population. Additionally, there
were fewer major adverse cardiovascular events observed
with Farxiga in the broad patient population; this did
not, however, reach statistical significance. During the period,
the Company received regulatory acceptances for the DECLARE
submissions in both the US and EU.
In March 2019, the Company announced that the EMA had
approved Forxiga for use in T1D as an adjunct to insulin in
patients with a body-mass index ≥ 27 kg/m2, when insulin
alone does not provide adequate glycaemic control, despite optimal
insulin therapy. In March 2019, the Company announced that the
Japanese Ministry of Health, Labour and Welfare had
approved Forxiga as an oral adjunct treatment to insulin for
adults with T1D. Forxiga is currently under regulatory review in the
US for use as an adjunct treatment to insulin in adults with T1D,
with a decision anticipated in the second half of
2019.
b) Bydureon (diabetes)
During the period, the US FDA approved label updates
for Bydureon and Bydureon
BCise to reflect safety
data from the EXSCEL (EXenatide Study of Cardiovascular Event
Lowering) trial, which demonstrated that Bydureon did not increase the risk of MACE in
patients with T2D and a broad range of CV risk.
c) Brilinta (myocardial
infarction)
During the period, the Company announced that the Phase III THEMIS
trial had met its primary endpoint and demonstrated
that Brilinta, taken in conjunction with aspirin, showed a
statistically-significant reduction in a composite of MACE,
compared to aspirin alone. THEMIS was conducted in over 19,000
patients with CAD and T2D with no history of prior heart attack
(myocardial infarction) or stroke. Preliminary safety results were
consistent with the known profile of Brilinta. The Company intends to present a full evaluation
of the THEMIS data at a forthcoming medical
meeting.
At the aforementioned ACC meeting, the Company presented data from
a secondary analysis of the Phase III TREAT trial, demonstrating
that that STEMI patients, aged 75 years or less, who
received Brilinta following fibrinolysis, had a similar
ischemic risk compared to those receiving clopidogrel, as measured
by the secondary efficacy endpoint which was a composite of CV
death, MI or stroke after 12 months of
treatment. Brilinta showed a similar efficacy in preventing CV
events compared to clopidogrel, with a numerical reduction in
events in the Brilinta arm; this was, however, not statistically
significant. The trial was designed primarily to test for
non-inferiority, compared to clopidogrel, for safety at 30 days and
was not powered statistically to detect significance of any
treatment effects. A secondary safety analysis of TREAT was
consistent with the known safety profile
of Brilinta.
Table 24: Key, large CVRM trials
Major CVRM outcomes trials are highlighted in the following
table:
|
Medicine
|
Trial
|
Mechanism
|
Population
|
Primary endpoint(s)
|
Timeline
|
|
Farxiga
|
DECLARE
|
SGLT2[46]inhibitor
|
c.17,000[47]patients
with type-2 diabetes
|
Superiority
for MACE or superiority for the composite endpoint of CV death or
hHF
|
Primary
safety endpoint met
One of
two primary efficacy endpoints met
|
|
Farxiga
|
DAPA-HF
|
SGLT2
inhibitor
|
c.4,500
patients with heart failure (HF) and reduced ejection fraction,
with and without type-2 diabetes
|
Time to
first occurrence of CV death or hHF or an urgent HF
visit
|
FPCD Q1
2017
LPCD Q3
2018
Data
anticipatedH2 2019
|
|
Farxiga
|
DELIVER
|
SGLT2
inhibitor
|
c.4,700
patients with HF and preserved ejection fraction, with and without
type-2 diabetes
|
Time to
first occurrence of CV death or worsening heart
failure
|
FPCD Q3
2018
Data
anticipated 2020+
|
|
Farxiga
|
DAPA-CKD
|
SGLT2
inhibitor
|
c.4,000
patients with CKD, with and without T2D
|
Time to first occurrence of ≥ 50% sustained decline in
eGFR[48] or
reaching ESRD[49] or
CV death or renal death
|
FPCD Q1
2017LPCD Q1 2019Data anticipated 2020+
|
|
Brilinta
|
THEMIS
|
P2Y12
receptor antagonist
|
c.19,000
patients with T2D and CAD without a history of MI or
stroke
|
Composite
of CV death, non-fatal MI and non-fatal stroke
|
Primary
endpoint metDetails to be presented at a forthcoming medical
meeting
|
|
Brilinta
|
THALES
|
P2Y12
receptor antagonist
|
c.13,000
patients with acute ischaemic stroke or transient ischaemic
attack
|
Prevention
of the composite of subsequent stroke and death at 30
days
|
FPCD Q1
2018
Data
anticipated 2020
|
|
Epanova
|
STRENGTH
|
Omega-3
carboxylic acids
|
c.13,000
patients with mixed dyslipidaemia/
hypertriglycerid-aemia
|
Time to
first occurrence of CV death, non-fatal MI or non-fatal
stroke
|
FPCD Q4
2014
LPCD Q2
2017
Data
anticipated 2020
|
d) Lokelma (hyperkalaemia)
During the period, DIALIZE, a multi-centre, randomised,
placebo-controlled, double-blinded Phase IIIb trial investigating
the efficacy of Lokelma as a treatment for patients with CKD on
haemodialysis with hyperkalaemia, met its primary endpoint. DIALIZE
was the first ever randomised, placebo-controlled trial to evaluate
a potassium binder in patients on haemodialysis and will
potentially inform regulatory updates in major markets. Before
DIALIZE, limited scientific research had been conducted on this
patient population. The Company intends to present results from the
trial at a forthcoming medical meeting.
During the period, patient enrolment in the Phase II PRIORITZE HF
trial was temporarily suspended. The trial was designed to evaluate
the benefits and risks of using Lokelma to initiate and intensify renin angiotensin
aldosterone system inhibitor (RAASi) therapy in HF patients. The
suspension followed the identification of larger than anticipated
measurement discrepancies between potassium-concentration levels at
point of care vs. those in central laboratories. The differences
identified resulted in some patients receiving inappropriate
management of RAASi medication. The trial is anticipated to resume,
following approval of an amendment to the trial protocol to measure
potassium-concentration levels in central laboratories. The
safety-monitoring committee recommended the continuation of the
trial as planned. AstraZeneca anticipates an update to
clinicaltrials.gov in due course.
e) Crestor (CV
disease)
During the period, the Company announced that the Phase III METEOR
China trial met its primary endpoint, demonstrating
thatCrestor slowed progression of carotid intima-media
thickness (CIMT) in adult Chinese patients with subclinical
atherosclerosis. The preliminary safety results were consistent
with the known safety profile of Crestor, which add long-term (two years) safety evidence
of Crestor in the adult Chinese population. METEOR
China was a randomised, double-blinded, placebo-controlled,
multi-centre, parallel group trial assessing the effects
of Crestor 20mg daily treatment for 104 weeks on the
change in CIMT in adult Chinese patients with subclinical
atherosclerosis. In total, 543 patients were randomised from 25
sites in China.
Respiratory
AstraZeneca's Respiratory focus is aimed at transforming the
treatment of patients with asthma and COPD through combined inhaled
therapies and biologic medicines for the unmet medical needs of
specific populations and an early pipeline focused on disease
modification. The growing range of medicines includes a number of
anticipated launches between 2017 and 2020; of
these, Bevespi and Fasenra are already benefitting patients, with
regulatory reviews for Symbicort as an anti-inflammatory reliever in mild
asthma and PT010 in COPD underway. The capability in inhalation
technology spans both pressurised metered-dose inhalers and
dry-powder inhalers to serve patient needs, including the
innovative Aerosphere Delivery Technology, a focus of
AstraZeneca's future-platform development for respiratory-disease
combination therapies.
a) Symbicort (asthma)
In February 2019, the Brazilian Health Regulatory Agency (ANVISA)
granted an expanded indication for Symbicort as a reliever of mild asthma symptoms. In
April, a similar approval was also granted by the Ministry of
Health of the Russian Federation. These approvals were based on
data from the SYGMA 1 and SYGMA 2 trials. SYGMA 1 showed that
using Symbicort as an anti-inflammatory reliever, in place
of a short-acting beta-agonist alone, has the potential to reduce
the risk of severe asthma attacks in this patient population by
64%.
In April 2019, the Global Initiative for Asthma (GINA) announced
updated global recommendations for clinical practice and the
treatment of patients with differing asthma severities. The 2019
GINA Pocket Guide for Asthma Management and Prevention recommends
the use of low dose ICS-formoterol combination therapy, as needed,
as the preferred reliever therapy across all asthma severities.
Short-acting beta-2 agonist monotherapy, as-needed, is no longer
recommended as a preferred reliever therapy.
b) Fasenra (asthma)
During the period, a Phase II trial demonstrated
that Fasenra can
achieve near-complete depletion of eosinophils and improve clinical
outcomes in hypereosinophilic syndrome (HES); the results were
published in the New
England Journal of Medicine. The US FDA granted Orphan Drug
Designation for Fasenra for
the treatment of HES in February 2019. Fasenra is
currently approved as an add-on maintenance treatment for patients
with severe, eosinophilic asthma in the US, EU, Japan and other
markets.
c) Tudorza (COPD)
In March 2019, the US FDA granted regulatory approval
for Tudorza based on the results from the ASCENT trial,
which fulfilled a post-approval commitment to conduct a randomised,
controlled trial to evaluate the risk of MACE
with Tudorza as a treatment for patients with COPD. The
trial achieved its co-primary endpoints for safety (MACE) and
efficacy (exacerbation reduction); the data from the ASCENT trial
has now been added to the US label. Tudorza is a LAMA, administered twice-daily via the
breath-actuated inhaler, Pressair. Tudorza was approved first in the US in 2012 for the
maintenance treatment of COPD.
d) Duaklir (COPD)
In March 2019, the US FDA approved Duaklir as a maintenance treatment for patients with
COPD. The approval was based on data from three Phase III trials,
namely ACLIFORM, AUGMENT and AMPLIFY. The label also included
clinical data from the ASCENT trial, which showed
that Duaklir was effective at reducing COPD
exacerbations. Duaklir is a fixed-dose LAMA/LABA combination,
administered twice-daily via Pressair. It is the only twice-daily LAMA/LABA treatment
in the US with COPD-exacerbation data included in its prescribing
information.
As part of the collaboration agreement announced in March 2017,
Circassia Pharmaceuticals plc will be responsible
for Duaklirin the US with AstraZeneca continuing to
manufacture and supply the medicine.
e) PT010 (COPD)
During the period, the Company received regulatory submission
acceptance for PT010 from the US FDA and the EMA, respectively. The
acceptance was based on results from the KRONOS Phase III trial,
which was published in The
Lancet Respiratory Medicine in October 2018. Results of
the Phase III ETHOS exacerbations trial are anticipated in H2 2019,
potentially further characterising the overall profile of PT010 as
a new medicine for patients with COPD.
f) Tezepelumab (severe, uncontrolled asthma)
During the period, the first patient was recruited into the Phase
III DESTINATION trial, evaluating the safety and tolerability of
tezepelumab in adults and adolescents with severe, uncontrolled
asthma.
g) Saracatinib (IPF)
In March 2019, the US FDA granted Orphan Drug
Designation for saracatinib, a potential new medicine for the
treatment of IPF, a type of lung disease that results in
scarring (fibrosis) of the lungs. IPF is a chronic, progressive,
irreversible and ultimately fatal interstitial lung disease which
affects c.100,000 patients per year in the US. Saracatinib is
an inhibitor of Src kinase, which regulates broad cell functions
including cell growth and cell differentiation. Pre-clinical trials
of saracatinib showed that it inhibits fibroblast activity and
collagen deposition, which are key features of lung fibrosis. More
recently, saracatinib completed its Phase I
development.
Other medicines
There were no research & development updates for medicines
outside of the three main therapy areas in the period.
For more details on the development pipeline, including anticipated
timelines for regulatory submission/acceptances, please refer to
the latest Clinical Trials
Appendix available
on astrazeneca.com.
Condensed consolidated statement of comprehensive
income
|
For
the quarter ended
31 March
|
|
2019
$m
|
|
2018
$m
|
|
Product
Sales
|
|
5,465
|
|
4,985
|
|
Collaboration
Revenue
|
|
26
|
|
193
|
|
Total Revenue
|
|
5,491
|
|
5,178
|
|
Cost of
sales
|
|
(1,129)
|
|
(1,134)
|
|
Gross profit
|
|
4,362
|
|
4,044
|
|
Distribution
costs
|
|
(78)
|
|
(81)
|
|
Research
and development expense
|
|
(1,266)
|
|
(1,279)
|
|
Selling,
general and administrative costs
|
|
(2,514)
|
|
(2,457)
|
|
Other
operating income and expense
|
|
593
|
|
469
|
|
Operating profit
|
|
1,097
|
|
696
|
|
Finance
income
|
|
55
|
|
35
|
|
Finance
expense
|
|
(367)
|
|
(343)
|
|
Share
of after-tax losses in associates and joint ventures
|
|
(27)
|
|
(14)
|
|
Profit before tax
|
|
758
|
|
374
|
|
Taxation
|
|
(195)
|
|
(58)
|
|
Profit for the period
|
|
563
|
|
316
|
|
|
|
|
|
|
|
Other comprehensive income
|
|
|
|
|
|
Items that will not be reclassified to profit or loss
|
|
|
|
|
|
Remeasurement
of the defined benefit pension liability
|
|
10
|
|
27
|
|
Net
gains on equity investments measured at fair value through other
comprehensive income
|
|
120
|
|
118
|
|
Fair
value movements related to own credit risk on bonds designated as
fair value through profit or loss
|
|
(1)
|
|
(1)
|
|
Tax on
items that will not be reclassified to profit or loss
|
|
(43)
|
|
(27)
|
|
|
|
86
|
|
117
|
|
Items that may be reclassified subsequently to profit or
loss
|
|
|
|
|
|
Foreign
exchange arising on consolidation
|
|
53
|
|
167
|
|
Foreign
exchange arising on designating borrowings in net investment
hedges
|
|
(180)
|
|
(99)
|
|
Fair
value movements on cash flow hedges
|
|
(54)
|
|
111
|
|
Fair
value movements on cash flow hedges transferred to profit or
loss
|
|
47
|
|
(80)
|
|
Fair
value movements on derivatives designated in net investment
hedges
|
|
3
|
|
(46)
|
|
Costs
of hedging
|
|
(6)
|
|
(10)
|
|
Tax on
items that may be reclassified subsequently to profit or
loss
|
|
23
|
|
20
|
|
|
|
(114)
|
|
63
|
|
Other comprehensive income for the period, net of tax
|
|
(28)
|
|
180
|
|
Total comprehensive income for the period
|
|
535
|
|
496
|
|
|
|
|
|
|
|
Profit attributable to:
|
|
|
|
|
|
Owners
of the Parent
|
|
593
|
|
340
|
|
Non-controlling
interests
|
|
(30)
|
|
(24)
|
|
|
|
563
|
|
316
|
|
|
|
|
|
|
|
Total comprehensive income attributable to:
|
|
|
|
|
|
Owners
of the Parent
|
|
565
|
|
520
|
|
Non-controlling
interests
|
|
(30)
|
|
(24)
|
|
|
|
535
|
|
496
|
|
|
|
|
|
|
|
Basic
earnings per $0.25 Ordinary Share
|
|
$0.47
|
|
$0.27
|
|
Diluted
earnings per $0.25 Ordinary Share
|
|
$0.47
|
|
$0.27
|
|
Weighted
average number of Ordinary Shares in issue (millions)
|
|
1,267
|
|
1,266
|
|
Diluted
weighted average number of Ordinary Shares in issue
(millions)
|
|
1,268
|
|
1,267
|
Condensed consolidated statement of financial position
|
|
|
At
31 Mar
2019
$m
|
|
At
31 Dec
2018
$m
|
|
At
31 Mar
2018
$m
|
|
ASSETS
Non-current assets
|
|
|
|
|
|
|
|
Property,
plant and equipment
|
|
7,446
|
|
7,421
|
|
7,721
|
|
Right-of-use
assets
|
|
707
|
|
-
|
|
-
|
|
Goodwill
|
|
11,674
|
|
11,707
|
|
11,834
|
|
Intangible
assets
|
|
22,852
|
|
21,959
|
|
25,850
|
|
Investments
in associates and joint ventures
|
|
76
|
|
89
|
|
187
|
|
Other
investments
|
|
1,530
|
|
833
|
|
987
|
|
Derivative
financial instruments
|
|
94
|
|
157
|
|
594
|
|
Other
receivables
|
|
496
|
|
515
|
|
525
|
|
Deferred
tax assets
|
|
2,531
|
|
2,379
|
|
2,401
|
|
|
|
47,406
|
|
45,060
|
|
50,099
|
|
Current assets
|
|
|
|
|
|
|
|
Inventories
|
|
3,050
|
|
2,890
|
|
3,283
|
|
Trade
and other receivables
|
|
5,289
|
|
5,574
|
|
5,444
|
|
Other
investments
|
|
822
|
|
849
|
|
866
|
|
Derivative
financial instruments
|
|
234
|
|
258
|
|
21
|
|
Income
tax receivable
|
|
118
|
|
207
|
|
563
|
|
Cash
and cash equivalents
|
|
4,136
|
|
4,831
|
|
3,005
|
|
Assets
held for sale
|
|
-
|
|
982
|
|
-
|
|
|
|
13,649
|
|
15,591
|
|
13,182
|
|
Total assets
|
|
61,055
|
|
60,651
|
|
63,281
|
|
LIABILITIES
Current liabilities
|
|
|
|
|
|
|
|
Interest-bearing
loans and borrowings
|
|
(3,544)
|
|
(1,754)
|
|
(4,170)
|
|
Lease
liabilities
|
|
(175)
|
|
-
|
|
-
|
|
Trade
and other payables
|
|
(13,102)
|
|
(12,841)
|
|
(11,481)
|
|
Derivative
financial instruments
|
|
(28)
|
|
(27)
|
|
(40)
|
|
Provisions
|
|
(397)
|
|
(506)
|
|
(1,011)
|
|
Income
tax payable
|
|
(1,010)
|
|
(1,164)
|
|
(1,462)
|
|
|
|
(18,256)
|
|
(16,292)
|
|
(18,164)
|
|
Non-current liabilities
|
|
|
|
|
|
|
|
Interest-bearing
loans and borrowings
|
|
(17,320)
|
|
(17,359)
|
|
(15,684)
|
|
Lease
liabilities
|
|
(539)
|
|
-
|
|
-
|
|
Derivative
financial instruments
|
|
(5)
|
|
(4)
|
|
(10)
|
|
Deferred
tax liabilities
|
|
(3,267)
|
|
(3,286)
|
|
(3,987)
|
|
Retirement
benefit obligations
|
|
(2,385)
|
|
(2,511)
|
|
(2,516)
|
|
Provisions
|
|
(379)
|
|
(385)
|
|
(384)
|
|
Other
payables
|
|
(6,875)
|
|
(6,770)
|
|
(7,963)
|
|
|
|
(30,770)
|
|
(30,315)
|
|
(30,544)
|
|
Total liabilities
|
|
(49,026)
|
|
(46,607)
|
|
(48,708)
|
|
Net assets
|
|
12,029
|
|
14,044
|
|
14,573
|
|
EQUITY
|
|
|
|
|
|
|
|
Capital and reserves attributable to equity holders of the
Company
|
|
|
|
|
|
|
|
Share
capital
|
|
317
|
|
317
|
|
317
|
|
Share
premium account
|
|
4,438
|
|
4,427
|
|
4,407
|
|
Other
reserves
|
|
2,046
|
|
2,041
|
|
2,027
|
|
Retained
earnings
|
|
3,682
|
|
5,683
|
|
6,164
|
|
|
|
10,483
|
|
12,468
|
|
12,915
|
|
Non-controlling interests
|
|
1,546
|
|
1,576
|
|
1,658
|
|
Total equity
|
|
12,029
|
|
14,044
|
|
14,573
|
Condensed consolidated statement of changes in equity
|
|
|
Share
capital
$m
|
|
Share
premium
account
$m
|
|
Other
reserves
$m
|
|
Retained
earnings
$m
|
|
Total
attributable
to
owners
$m
|
|
Non-
controlling interests
$m
|
|
Total
equity
$m
|
|
At
1 Jan 2018
|
|
317
|
|
4,393
|
|
2,029
|
|
8,221
|
|
14,960
|
|
1,682
|
|
16,642
|
|
Adoption of new
accounting standards
|
|
-
|
-
|
-
|
-
|
-
|
|
(91)
|
|
(91)
|
|
-
|
|
(91)
|
|
Profit
for the period
|
|
-
|
|
-
|
|
-
|
|
340
|
|
340
|
|
(24)
|
|
316
|
|
Other
comprehensive income
|
|
-
|
|
-
|
|
-
|
|
180
|
|
180
|
|
-
|
|
180
|
|
Transfer to other
reserves
|
|
-
|
|
-
|
|
(2)
|
|
2
|
|
-
|
|
-
|
|
-
|
|
Transactions
with owners:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends
|
|
-
|
|
-
|
|
-
|
|
(2,402)
|
|
(2,402)
|
|
-
|
|
(2,402)
|
|
Issue
of Ordinary Shares
|
|
-
|
|
14
|
|
-
|
|
-
|
|
14
|
|
-
|
|
14
|
|
Share-based
payments charge for the period
|
|
-
|
|
-
|
|
-
|
|
52
|
|
52
|
|
-
|
|
52
|
|
Settlement of share
plan awards
|
|
-
|
|
-
|
|
-
|
|
(138)
|
|
(138)
|
|
-
|
|
(138)
|
|
Net
movement
|
|
-
|
|
14
|
|
(2)
|
|
(2,057)
|
|
(2,045)
|
|
(24)
|
|
(2,069)
|
|
At
31 Mar 2018
|
|
317
|
|
4,407
|
|
2,027
|
|
6,164
|
|
12,915
|
|
1,658
|
|
14,573
|
|
|
|
Share
capital
$m
|
|
Share
premium
account
$m
|
|
Other
reserves
$m
|
|
Retained
earnings
$m
|
|
Total
attributable
to
owners
$m
|
|
Non-
controlling interests
$m
|
|
Total
equity
$m
|
|
At
1 Jan 2019
|
|
317
|
|
4,427
|
|
2,041
|
|
5,683
|
|
12,468
|
|
1,576
|
|
14,044
|
|
Adoption of new accounting
standards[50]
|
|
-
|
|
-
|
|
-
|
|
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
|
Condensed consolidated statement of cash flows
|
For
the quarter ended
31 March
|
|
2019
$m
|
|
2018
$m
|
|
Cash flows from operating activities
|
|
|
|
|
|
Profit
before tax
|
|
758
|
|
374
|
|
Finance
income and expense
|
|
312
|
|
308
|
|
Share
of after-tax losses of associates and joint ventures
|
|
27
|
|
14
|
|
Depreciation,
amortisation and impairment
|
|
676
|
|
709
|
|
Increase
in working capital and short-term provisions
|
|
(710)
|
|
(993)
|
|
Gains
on disposal of intangible assets
|
|
(512)
|
|
(65)
|
|
Non-cash
and other movements
|
|
(396)
|
|
(242)
|
|
Cash generated from operations
|
|
155
|
|
105
|
|
Interest
paid
|
|
(208)
|
|
(128)
|
|
Tax
paid
|
|
(334)
|
|
(117)
|
|
Net cash outflow from operating activities
|
|
(387)
|
|
(140)
|
|
Cash flows from investing activities
|
|
|
|
|
|
Payment
of contingent consideration from business combinations
|
|
(219)
|
|
(62)
|
|
Purchase
of property, plant and equipment
|
|
(174)
|
|
(213)
|
|
Disposal
of property, plant and equipment
|
|
28
|
|
2
|
|
Purchase
of intangible assets
|
|
(586)
|
|
(121)
|
|
Disposal
of intangible assets
|
|
1,071
|
|
362
|
|
Movement
in profit-participation liability
|
|
150
|
|
-
|
|
Purchase
of non-current asset investments
|
|
(3)
|
|
(4)
|
|
Disposal
of non-current asset investments
|
|
17
|
|
1
|
|
Movement
in short-term investments and fixed deposits
|
|
20
|
|
436
|
|
Payments
to joint ventures
|
|
(12)
|
|
(161)
|
|
Interest
received
|
|